Title 9 Animals and Animal Products Parts 1 to 199

Revised as of January 1, 2013

Containing a codification of documents of general applicability and future effect

As of January 1, 2013

Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register

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Legal Status and Use of Seals and Logos The seal of the National Archives and Records Administration (NARA) authenticates the Code of Federal Regulations (CFR) as the official codification of Federal regulations established under the Federal Register Act. Under the provisions of 44 U.S.C. 1507, the contents of the CFR, a special edition of the Federal Register, shall be judicially noticed. The CFR is prima facie evidence of the original documents published in the Federal Register (44 U.S.C. 1510). It is prohibited to use NARA’s official seal and the stylized Code of Federal Regulations logo on any republication of this material without the express, written permission of the Archivist of the United States or the Archivist’s designee. Any person using NARA’s official seals and logos in a manner inconsistent with the provisions of 36 CFR part 1200 is subject to the penalties specified in 18 U.S.C. 506, 701, and 1017.

Use of ISBN Prefix This is the Official U.S. Government edition of this publication and is herein identified to certify its authenticity. Use of the 0–16 ISBN prefix is for U.S. Government Printing Office Official Edi- tions only. The Superintendent of Documents of the U.S. Govern- ment Printing Office requests that any reprinted edition clearly be labeled as a copy of the authentic work with a new ISBN.

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Page Explanation ...... v

Title 9:

Chapter I—Animal and Plant Health Inspection Service, Depart- ment of Agriculture ...... 3

Finding Aids:

Table of CFR Titles and Chapters ...... 1031

Alphabetical List of Agencies Appearing in the CFR ...... 1051

List of CFR Sections Affected ...... 1061

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To cite the regulations in this volume use title, part and section number. Thus, 9 CFR 1.1 refers to title 9, part 1, section 1.

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The Code of Federal Regulations is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. The Code is divided into 50 titles which represent broad areas subject to Federal regulation. Each title is divided into chapters which usually bear the name of the issuing agency. Each chapter is further sub- divided into parts covering specific regulatory areas. Each volume of the Code is revised at least once each calendar year and issued on a quarterly basis approximately as follows: Title 1 through Title 16...... as of January 1 Title 17 through Title 27 ...... as of April 1 Title 28 through Title 41 ...... as of July 1 Title 42 through Title 50...... as of October 1 The appropriate revision date is printed on the cover of each volume. LEGAL STATUS The contents of the Federal Register are required to be judicially noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie evidence of the text of the original documents (44 U.S.C. 1510). HOW TO USE THE CODE OF FEDERAL REGULATIONS The Code of Federal Regulations is kept up to date by the individual issues of the Federal Register. These two publications must be used together to determine the latest version of any given rule. To determine whether a Code volume has been amended since its revision date (in this case, January 1, 2013), consult the ‘‘List of CFR Sections Affected (LSA),’’ which is issued monthly, and the ‘‘Cumulative List of Parts Affected,’’ which appears in the Reader Aids section of the daily Federal Register. These two lists will identify the Federal Register page number of the latest amendment of any given rule. EFFECTIVE AND EXPIRATION DATES Each volume of the Code contains amendments published in the Federal Reg- ister since the last revision of that volume of the Code. Source citations for the regulations are referred to by volume number and page number of the Federal Register and date of publication. Publication dates and effective dates are usually not the same and care must be exercised by the user in determining the actual effective date. In instances where the effective date is beyond the cut- off date for the Code a note has been inserted to reflect the future effective date. In those instances where a regulation published in the Federal Register states a date certain for expiration, an appropriate note will be inserted following the text. OMB CONTROL NUMBERS The Paperwork Reduction Act of 1980 (Pub. L. 96–511) requires Federal agencies to display an OMB control number with their information collection request.

VerDate Mar<15>2010 15:28 Mar 12, 2013 Jkt 229028 PO 00000 Frm 00005 Fmt 8008 Sfmt 8092 Y:\SGML\229028.XXX 229028 wreier-aviles on DSK5TPTVN1PROD with CFR Many agencies have begun publishing numerous OMB control numbers as amendments to existing regulations in the CFR. These OMB numbers are placed as close as possible to the applicable recordkeeping or reporting requirements. PAST PROVISIONS OF THE CODE Provisions of the Code that are no longer in force and effect as of the revision date stated on the cover of each volume are not carried. Code users may find the text of provisions in effect on any given date in the past by using the appropriate List of CFR Sections Affected (LSA). For the convenience of the reader, a ‘‘List of CFR Sections Affected’’ is published at the end of each CFR volume. For changes to the Code prior to the LSA listings at the end of the volume, consult previous annual editions of the LSA. For changes to the Code prior to 2001, consult the List of CFR Sections Affected compilations, published for 1949- 1963, 1964-1972, 1973-1985, and 1986-2000. ‘‘[RESERVED]’’ TERMINOLOGY The term ‘‘[Reserved]’’ is used as a place holder within the Code of Federal Regulations. An agency may add regulatory information at a ‘‘[Reserved]’’ location at any time. Occasionally ‘‘[Reserved]’’ is used editorially to indicate that a portion of the CFR was left vacant and not accidentally dropped due to a printing or computer error. INCORPORATION BY REFERENCE What is incorporation by reference? Incorporation by reference was established by statute and allows Federal agencies to meet the requirement to publish regulations in the Federal Register by referring to materials already published elsewhere. For an incorporation to be valid, the Director of the Federal Register must approve it. The legal effect of incorporation by reference is that the material is treated as if it were published in full in the Federal Register (5 U.S.C. 552(a)). This material, like any other properly issued regulation, has the force of law. What is a proper incorporation by reference? The Director of the Federal Register will approve an incorporation by reference only when the requirements of 1 CFR part 51 are met. Some of the elements on which approval is based are: (a) The incorporation will substantially reduce the volume of material published in the Federal Register. (b) The matter incorporated is in fact available to the extent necessary to afford fairness and uniformity in the administrative process. (c) The incorporating document is drafted and submitted for publication in accordance with 1 CFR part 51. What if the material incorporated by reference cannot be found? If you have any problem locating or obtaining a copy of material listed as an approved incorporation by reference, please contact the agency that issued the regulation containing that incorporation. If, after contacting the agency, you find the material is not available, please notify the Director of the Federal Register, National Archives and Records Administration, 8601 Adelphi Road, College Park, MD 20740-6001, or call 202-741-6010. CFR INDEXES AND TABULAR GUIDES A subject index to the Code of Federal Regulations is contained in a separate volume, revised annually as of January 1, entitled CFR INDEX AND FINDING AIDS. This volume contains the Parallel Table of Authorities and Rules. A list of CFR titles, chapters, subchapters, and parts and an alphabetical list of agencies publishing in the CFR are also included in this volume.

VerDate Mar<15>2010 15:28 Mar 12, 2013 Jkt 229028 PO 00000 Frm 00006 Fmt 8008 Sfmt 8092 Y:\SGML\229028.XXX 229028 wreier-aviles on DSK5TPTVN1PROD with CFR An index to the text of ‘‘Title 3—The President’’ is carried within that volume. The Federal Register Index is issued monthly in cumulative form. This index is based on a consolidation of the ‘‘Contents’’ entries in the daily Federal Reg- ister. A List of CFR Sections Affected (LSA) is published monthly, keyed to the revision dates of the 50 CFR titles. REPUBLICATION OF MATERIAL There are no restrictions on the republication of material appearing in the Code of Federal Regulations. INQUIRIES For a legal interpretation or explanation of any regulation in this volume, contact the issuing agency. The issuing agency’s name appears at the top of odd-numbered pages. For inquiries concerning CFR reference assistance, call 202–741–6000 or write to the Director, Office of the Federal Register, National Archives and Records Administration, 8601 Adelphi Road, College Park, MD 20740-6001 or e-mail [email protected]. SALES The Government Printing Office (GPO) processes all sales and distribution of the CFR. For payment by credit card, call toll-free, 866-512-1800, or DC area, 202- 512-1800, M-F 8 a.m. to 4 p.m. e.s.t. or fax your order to 202-512-2104, 24 hours a day. For payment by check, write to: US Government Printing Office – New Orders, P.O. Box 979050, St. Louis, MO 63197-9000. ELECTRONIC SERVICES The full text of the Code of Federal Regulations, the LSA (List of CFR Sections Affected), The United States Government Manual, the Federal Register, Public Laws, Public Papers of the Presidents of the United States, Compilation of Presi- dential Documents and the Privacy Act Compilation are available in electronic format via www.ofr.gov. For more information, contact the GPO Customer Con- tact Center, U.S. Government Printing Office. Phone 202-512-1800, or 866-512-1800 (toll-free). E-mail, [email protected]. The Office of the Federal Register also offers a free service on the National Archives and Records Administration’s (NARA) World Wide Web site for public law numbers, Federal Register finding aids, and related information. Connect to NARA’s web site at www.archives.gov/federal-register. The e-CFR is a regularly updated, unofficial editorial compilation of CFR material and Federal Register amendments, produced by the Office of the Federal Register and the Government Printing Office. It is available at www.ecfr.gov.

CHARLES A. BARTH, Director, Office of the Federal Register. January 1, 2013.

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Title 9—ANIMALS AND ANIMAL PRODUCTS is composed of two volumes. The first volume contains chapter I—Animal and Plant Health Inspection Service, Depart- ment of Agriculture (parts 1–199). The second volume contains chapter II—Pack- ers and Stockyards Administration, Department of Agriculture and chapter III— Food Safety and Inspection Service, Department of Agriculture (part 200–End). The contents of these volumes represent all current regulations codified under this title of the CFR as of January 1, 2013.

For this volume, Cheryl E. Sirofchuck was Chief Editor. The Code of Federal Regulations publication program is under the direction of Michael L. White, as- sisted by Ann Worley.

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(This book contains parts 1 to 199)

EDITORIAL NOTE: Other regulations issued by the Department of Agriculture appear in title 7, title 36, chapter II, and title 41, chapter 4.

Part

CHAPTER I—Animal and Plant Health Inspection Service, Department of Agriculture ...... 1

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SUBCHAPTER A—ANIMAL WELFARE

Part Page 1 Definition of terms ...... 7 2 Regulations ...... 13 3 Standards ...... 46 4 Rules of practice governing proceedings under the Animal Welfare Act ...... 126 11 Horse protection regulations ...... 127 12 Rules of practice governing proceedings under the Horse Protection Act ...... 145

SUBCHAPTER B—COOPERATIVE CONTROL AND ERADICATION OF LIVESTOCK OR POULTRY DISEASES 49 Rules of practice governing proceedings under certain acts ...... 146 50 Animals destroyed because of tuberculosis ...... 146 51 Animals destroyed because of brucellosis ...... 156 52 Swine destroyed because of pseudorabies ...... 169 53 Foot-and-mouth disease, pleuropneumonia, rinderpest, and certain other communicable diseases of livestock or poultry ...... 173 54 Control of scrapie ...... 177 55 Control of chronic wasting disease ...... 191 56 Control of H5/H7 low pathogenic avian influenza .... 202

SUBCHAPTER C—INTERSTATE TRANSPORTATION OF ANIMALS (INCLUDING POULTRY) AND ANIMAL PRODUCTS 70 Rules of practice governing proceedings under certain acts ...... 211 71 General provisions...... 211 72 Texas (splenetic) fever in cattle ...... 233 73 Scabies in cattle ...... 238

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Part Page 74 Prohibition of interstate movement of land tortoises ...... 244 75 Communicable diseases in horses, asses, ponies, mules, and zebras ...... 245 76 [Reserved] 77 Tuberculosis ...... 248 78 Brucellosis ...... 277 79 Scrapie in sheep and goats ...... 316 80 Johne’s disease in domestic animals ...... 338 81 Chronic wasting disease in deer, elk, and moose ..... 340 82 Exotic Newcastle Disease (END) and chlamydiosis 344 83 Viral hemorrhagic septicemia ...... 358 85 Pseudorabies ...... 362 88 Commercial transportation of equines for slaughter ...... 375 89 Statement of policy under the Twenty-Eight Hour Law ...... 378

SUBCHAPTER D—EXPORTATION AND IMPORTATION OF ANIMALS (INCLUDING POULTRY) AND ANIMAL PRODUCTS 91 Inspection and handling of livestock for exportation ...... 381 92 Importation of animals and animal products: Pro- cedures for requesting recognition of regions ...... 396 93 Importation of certain animals, birds, fish, and poultry, and certain animal, bird, and poultry products; requirements for means of conveyance and shipping containers ...... 399 94 Rinderpest, foot-and-mouth disease, exotic New- castle disease, African swine fever, classical swine fever, swine vesicular disease, and bovine spongiform encephalopathy: prohibited and restricted importations ...... 543 95 Sanitary control of animal byproducts (except casings), and hay and straw, offered for entry into the United States ...... 593 96 Restriction of importations of foreign animal casings offered for entry into the United States ...... 610 97 Overtime services relating to imports and exports 617 98 Importation of certain animal embryos and animal semen ...... 624 99 Rules of practice governing proceedings under certain acts ...... 647

SUBCHAPTER E—VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS 101 Definitions ...... 648 4

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Part Page 102 Licenses for biological products ...... 653 103 Experimental production, distribution, and evaluation of biological products prior to licensing ...... 657 104 Permits for biological products ...... 658 105 Suspension, revocation, or termination of biological licenses or permits ...... 661 106 Exemption for biological products used in department programs or under department control or supervision ...... 663 107 Exemptions from preparation pursuant to an unsuspended and unrevoked license ...... 663 108 Facility requirements for licensed establishments 664 109 Sterilization and pasteurization at licensed establishments ...... 668 112 Packaging and labeling ...... 668 113 Standard requirements...... 677 114 Production requirements for biological products ... 804 115 Inspections ...... 814 116 Records and reports ...... 815 117 Animals at licensed establishments ...... 817 118 Detention; seizure and condemnation ...... 819 121 Possession, use, and transfer of select agents and toxins ...... 821 122 Organisms and vectors ...... 840 123 Rules of practice governing proceedings under the Virus-Serum-Toxin Act ...... 841 124 Patent term restoration ...... 841

SUBCHAPTER F—USER FEES 130 User fees...... 847

SUBCHAPTER G—LIVESTOCK IMPROVEMENT 145 National Poultry Improvement Plan for Breeding Poultry ...... 870 146 National Poultry Improvement Plan for Commer- cial Poultry ...... 922 147 Auxiliary provisions on National Poultry Improve- ment Plan ...... 934 149 Voluntary Trichinae Certification Program ...... 978

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Part SUBCHAPTER H—ANIMAL BREEDS Page 151 Recognition of breeds and books of record of purebred animals ...... 994

SUBCHAPTER I—VOLUNTARY INSPECTION AND CERTIFICATION SERVICE 156 Voluntary inspection and certification service ...... 1005

SUBCHAPTER J—ACCREDITATION OF VETERINARIANS AND SUSPENSION OR REVOCATION OF SUCH ACCREDITATION 160 Definition of terms ...... 1008 161 Requirements and standards for accredited veterinarians and suspension or revocation of such accreditation ...... 1009 162 Rules of practice governing revocation or suspension of veterinarians’ accreditation ...... 1017

SUBCHAPTER K—PUBLIC INFORMATION 165 Availability of information ...... 1019

SUBCHAPTER L—SWINE HEALTH PROTECTION 166 Swine health protection ...... 1020 167 Rules of practice governing proceedings under the Swine Health Protection Act ...... 1026 168–199 [Reserved]

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PART 1—DEFINITION OF TERMS Ambient temperature means the air temperature surrounding the animal. Animal means any live or dead dog, AUTHORITY: 7 U.S.C. 2131–2159; 7 CFR 2.22, cat, nonhuman primate, guinea pig, 2.80, and 371.7. hamster, rabbit, or any other warmblooded animal, which is being used, or § 1.1 Definitions. is intended for use for research, teach- For the purposes of this subchapter, ing, testing, experimentation, or exhi- unless the context otherwise requires, bition purposes, or as a pet. This term the following terms shall have the excludes birds, rats of the genus Rattus, meanings assigned to them in this sec- and mice of the genus Mus, bred for use tion. The singular form shall also sig- in research; horses not used for re- nify the plural and the masculine form search purposes; and other farm ani- shall also signify the feminine. Words mals, such as, but not limited to, live- undefined in the following paragraphs stock or poultry used or intended for shall have the meaning attributed to use as food or fiber, or livestock or them in general usage as reflected by poultry used or intended for use for im- definitions in a standard dictionary. proving animal nutrition, breeding, AC Regional Director means a veteri- management, or production efficiency, narian or his designee, employed by or for improving the quality of food or APHIS, who is assigned by the Admin- fiber. With respect to a dog, the term istrator to supervise and perform the means all dogs, including those used official work of APHIS in a given State for hunting, security, or breeding purposes. or States. As used in part 2 of this sub- Animal act means any performance of chapter, the AC Regional Director animals where such animals are shall be deemed to be the person in trained to perform some behavior or charge of the official work of APHIS in action or are part of a show, perform- the State in which the dealer, exhibi- ance, or exhibition. tor, research facility, intermediate APHIS official means any person em- handler, carrier, or operator of an auc- ployed by the Department who is au- tion sale has his principal place of busi- thorized to perform a function under ness. the Act and the regulations in 9 CFR Act means the Act of August 24, 1966 parts 1, 2, and 3. (Pub. L. 89–544), (commonly known as Attending veterinarian means a person the Laboratory Animal Welfare Act), who has graduated from a veterinary as amended by the Act of December 24, school accredited by the American Vet- 1970 (Pub. L. 91–579), (the Animal Wel- erinary Medical Association’s Council fare Act of 1970), the Act of April 22, on Education, or has a certificate 1976 (Pub. L. 94–279), (the Animal Wel- issued by the American Veterinary fare Act of 1976), and the Act of Decem- Medical Association’s Education Com- ber 23, 1985 (Pub. L. 99–198), (the Food mission for Foreign Veterinary Grad- Security Act of 1985), and as it may be uates, or has received equivalent for- subsequently amended. mal education as determined by the Activity means, for purposes of part 2, Administrator; has received training subpart C of this subchapter, those ele- and/or experience in the care and man- ments of research, testing, or teaching agement of the species being attended; procedures that involve the care and and who has direct or delegated au- use of animals. thority for activities involving animals Administrative unit means the organi- at a facility subject to the jurisdiction zational or management unit at the de- of the Secretary. partmental level of a research facility. Buffer area means that area in a pri- Administrator. The Administrator, mary enclosure for a swim-with-the- Animal and Plant Health Inspection dolphin program that is off-limits to Service, or any person authorized to members of the public and that di- act for the Administrator. rectly abuts the interactive area.

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Business hours means a reasonable through any place outside thereof, or number of hours between 7 a.m. and 7 within any territory, possession, or the p.m., Monday through Friday, except District of Columbia; or for legal Federal holidays, each week (2) Which affects the commerce de- of the year, during which inspections scribed in this part. by APHIS may be made. Committee means the Institutional Business year means the 12-month pe- Animal Care and Use Committee riod during which business is con- (IACUC) established under section 13(b) ducted, and may be either on a cal- of the Act. It shall consist of at least endar or fiscal-year basis. three (3) members, one of whom is the means the operator of any air- Carrier attending veterinarian of the research line, railroad, motor carrier, shipping facility and one of whom is not affili- line, or other enterprise which is en- ated in any way with the facility other gaged in the business of transporting than as a member of the committee, any animals for hire. Cat means any live or dead cat (Felis however, if the research facility has catus) or any cat-hybrid cross. more than one Doctor of Veterinary Class ‘‘A’’ licensee (breeder) means a Medicine (DVM), another DVM with person subject to the licensing require- delegated program responsibility may ments under part 2 and meeting the serve. The research facility shall estab- definition of a ‘‘dealer’’ (§ 1.1), and lish the Committee for the purpose of whose business involving animals con- evaluating the care, treatment, hous- sists only of animals that are bred and ing, and use of animals, and for certi- raised on the premises in a closed or fying compliance with the Act by the stable colony and those animals ac- research facility. quired for the sole purpose of maintain- Dealer means any person who, in ing or enhancing the breeding colony. commerce, for compensation or profit, Class ‘‘B’’ licensee means a person delivers for transportation, or trans- subject to the licensing requirements ports, except as a carrier, buys, or under part 2 and meeting the definition sells, or negotiates the purchase or sale of a ‘‘dealer’’ (§ 1.1), and whose business of: Any dog or other animal whether includes the purchase and/or resale of alive or dead (including unborn ani- any animal. This term includes bro- mals, organs, limbs, blood, serum, or kers, and operators of an auction sale, other parts) for research, teaching, as such individuals negotiate or ar- testing, experimentation, exhibition, range for the purchase, sale, or trans- or for use as a pet; or any dog at the port of animals in commerce. Such in- wholesale level for hunting, security, dividuals do not usually take actual or breeding purposes. This term does physical possession or control of the not include: A retail pet store, as de- animals, and do not usually hold ani- fined in this section, unless such store mals in any facilities. A class ‘‘B’’ li- sells any animal to a research facility, censee may also exhibit animals as a an exhibitor, or a dealer (wholesale); minor part of the business. any retail outlet where dogs are sold Class ‘‘C’’ licensee (exhibitor) means a person subject to the licensing require- for hunting, breeding, or security pur- ments under part 2 and meeting the poses; or any person who does not sell definition of an ‘‘exhibitor’’ (§ 1.1), and or negotiate the purchase or sale of whose business involves the showing or any wild or exotic animal, dog, or cat displaying of animals to the public. A and who derives no more than $500 class ‘‘C’’ licensee may buy and sell gross income from the sale of animals animals as a minor part of the business other than wild or exotic animals, in order to maintain or add to his ani- dogs, or cats during any calendar year. mal collection. Department means the U.S. Depart- Commerce means trade, traffic, trans- ment of Agriculture. portation, or other commerce: Deputy Administrator means the Dep- (1) Between a place in a State and uty Administrator for Animal Care any place outside of such State, includ- (AC) or any other official of AC to ing any foreign country, or between whom authority has been delegated to points within the same State but act in his stead.

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Dog means any live or dead dog or intended for use as food or fiber, or (Canis familiaris) or any dog-hybrid for improving animal nutrition, breed- cross. ing, management, or production effi- Dwarf hamster means any species of ciency, or for improving the quality of hamster such as the Chinese and Arme- food or fiber. This term also includes nian species whose adult body size is animals such as rabbits, mink, and substantially less than that attained chinchilla, when they are used solely by the Syrian or Golden species of for purposes of meat or fur, and ani- hamsters. mals such as horses and llamas when Endangered species means those spe- used solely as work and pack animals. cies defined in the Endangered Species Federal agency means an Executive Act (16 U.S.C. 1531 et seq.) and as it may agency as such term is defined in sec- be subsequently amended. tion 105 of title 5, United States Code, Euthanasia means the humane de- and with respect to any research facil- struction of an animal accomplished by ity means the agency from which the a method that produces rapid uncon- sciousness and subsequent death with- research facility receives a Federal out evidence of pain or distress, or a award for the conduct of research, ex- method that utilizes anesthesia pro- perimentation, or testing involving the duced by an agent that causes painless use of animals. loss of consciousness and subsequent Federal award means any mechanism death (including a grant, award, loan, con- Exhibitor means any person (public or tract, or cooperative agreement) under private) exhibiting any animals, which which Federal funds are used to sup- were purchased in commerce or the in- port the conduct of research, experi- tended distribution of which affects mentation, or testing, involving the commerce, or will affect commerce, to use of animals. The permit system es- the public for compensation, as deter- tablished under the authorities of the mined by the Secretary. This term in- Endangered Species Act, the Marine cludes carnivals, circuses, animal acts, Mammal Protection Act, and the Mi- zoos, and educational exhibits, exhib- gratory Bird Treaty Act, are not con- iting such animals whether operated sidered to be Federal awards under the for profit or not. This term excludes re- Animal Welfare Act. tail pet stores, horse and dog races, or- Federal research facility means each ganizations sponsoring and all persons department, agency, or instrumen- participating in State and county fairs, tality of the United States which uses livestock shows, rodeos, field trials, live animals for research or experimen- coursing events, purebred dog and cat tation. shows and any other fairs or exhibi- Field study means a study conducted tions intended to advance agricultural on free-living wild animals in their arts and sciences as may be determined natural habitat. However, this term ex- by the Secretary. cludes any study that involves an Exotic animal means any animal not invasive procedure, harms, or materi- identified in the definition of ‘‘animal’’ ally alters the behavior of an animal provided in this part that is native to a under study. foreign country or of foreign origin or character, is not native to the United Handling means petting, feeding, wa- States, or was introduced from abroad. tering, cleaning, manipulating, load- This term specifically includes animals ing, crating, shifting, transferring, im- such as, but not limited to, lions, ti- mobilizing, restraining, treating, train- gers, leopards, elephants, camels, ante- ing, working and moving, or any simi- lope, anteaters, kangaroos, and water lar activity with respect to any ani- buffalo, and species of foreign domestic mal. cattle, such as Ankole, Gayal, and Yak. Housing facility means any land, Farm animal means any domestic spe- premises, shed, barn, building, trailer, cies of cattle, sheep, swine, goats, lla- or other structure or area housing or mas, or horses, which are normally and intended to house animals. have historically, been kept and raised Hybrid cross means an animal result- on farms in the United States, and used ing from the crossbreeding between

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two different species or types of ani- gaged in any business in which he re- mals. Crosses between wild animal spe- ceives custody of animals in connec- cies, such as lions and tigers, are con- tion with their transportation in com- sidered to be wild animals. Crosses be- merce. tween wild animal species and domes- Inspector means any person employed tic animals, such as dogs and wolves or by the Department who is authorized buffalo and domestic cattle, are consid- to perform a function under the Act ered to be domestic animals. and the regulations in 9 CFR parts 1, 2, Impervious surface means a surface and 3. that does not permit the absorption of Institutional official means the indi- fluids. Such surfaces are those that can vidual at a research facility who is au- be thoroughly and repeatedly cleaned thorized to legally commit on behalf of and disinfected, will not retain odors, the research facility that the require- and from which fluids bead up and run ments of 9 CFR parts 1, 2, and 3 will be off or can be removed without their met. being absorbed into the surface mate- Isolation in regard to marine mam- rial. mals means the physical separation of Indoor housing facility means any animals to prevent contact and a sepa- structure or building with environ- rate, noncommon, water circulation mental controls housing or intended to and filtration system for the isolated house animals and meeting the fol- animals. lowing three requirements: Licensed veterinarian means a person (1) It must be capable of controlling who has graduated from an accredited the temperature within the building or school of veterinary medicine or has structure within the limits set forth received equivalent formal education for that species of animal, of maintain- as determined by the Administrator, ing humidity levels of 30 to 70 percent and who has a valid license to practice and of rapidly eliminating odors from veterinary medicine in some State. within the building; and Licensee means any person licensed (2) It must be an enclosure created by according to the provisions of the Act the continuous connection of a roof, and the regulations in part 2 of this floor, and walls (a shed or barn set on subchapter. top of the ground does not have a con- Major operative procedure means any tinuous connection between the walls surgical intervention that penetrates and the ground unless a foundation and and exposes a body cavity or any proce- floor are provided); and dure which produces permanent im- (3) It must have at least one door for pairment of physical or physiological entry and exit that can be opened and functions. closed (any windows or openings which Minimum horizontal dimension (MHD) provide natural light must be covered means the diameter of a circular pool with a transparent material such as of water, or in the case of a square, rec- glass or hard plastic). tangle, oblong, or other shape pool, the Interactive area means that area in a diameter of the largest circle that can primary enclosure for a swim-with-the- be inserted within the confines of such dolphin program where an interactive a pool of water. session takes place. Mobile or traveling housing facility Interactive session means a swim-with- means a transporting vehicle such as a the-dolphin program session where truck, trailer, or railway car, used to members of the public enter a primary house animals while traveling for exhi- enclosure to interact with cetaceans. bition or public education purposes. Intermediate handler means any per- Nonconditioned animals means ani- son, including a department, agency, or mals which have not been subjected to instrumentality of the United States special care and treatment for suffi- or of any State or local government cient time to stabilize, and where nec- (other than a dealer, research facility, essary, to improve their health. exhibitor, any person excluded from Nonhuman primate means any the definition of a dealer, research fa- nonhuman member of the highest order cility, or exhibitor, an operator of an of mammals including prosimians, auction sale, or a carrier), who is en- monkeys, and apes.

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Operator of an auction sale means any Principal investigator means an em- person who is engaged in operating an ployee of a research facility, or other auction at which animals are pur- person associated with a research facil- chased or sold in commerce. ity, responsible for a proposal to con- Outdoor housing facility means any duct research and for the design and structure, building, land, or premise, implementation of research involving housing or intended to house animals, animals. which does not meet the definition of Quorum means a majority of the any other type of housing facility pro- Committee members. vided in the regulations, and in which Random source means dogs and cats temperatures cannot be controlled obtained from animal pounds or shel- within set limits. ters, auction sales, or from any person Painful procedure as applied to any who did not breed and raise them on animal means any procedure that his or her premises. would reasonably be expected to cause Registrant means any research facil- more than slight or momentary pain or ity, carrier, intermediate handler, or distress in a human being to which exhibitor not required to be licensed that procedure was applied, that is, under section 3 of the Act, registered pain in excess of that caused by injec- pursuant to the provisions of the Act tions or other minor procedures. and the regulations in part 2 of this Paralytic drug means a drug which subchapter. causes partial or complete loss of mus- Research facility means any school cle contraction and which has no anes- (except an elementary or secondary thetic or analgesic properties, so that school), institution, organization, or the animal cannot move, but is completely aware of its surroundings and person that uses or intends to use live can feel pain. animals in research, tests, or experiments, and that (1) purchases or trans- Person means any individual, partnership, firm, joint stock company, ports live animals in commerce, or (2) corporation, association, trust, estate, receives funds under a grant, award, or other legal entity. loan, or contract from a department, Pet animal means any animal that agency, or instrumentality of the has commonly been kept as a pet in United States for the purpose of car- family households in the United rying out research, tests, or experi- States, such as dogs, cats, guinea pigs, ments: Provided, That the Adminis- rabbits, and hamsters. This term ex- trator may exempt, by regulation, any cludes exotic animals and wild ani- such school, institution, organization, mals. or person that does not use or intend to Positive physical contact means pet- use live dogs or cats, except those ting, stroking, or other touching, schools, institutions, organizations, or which is beneficial to the well-being of persons, which use substantial numbers the animal. (as determined by the Administrator) Pound or shelter means a facility that of live animals the principal function accepts and/or seizes animals for the of which schools, institutions, organi- purpose of caring for them, placing zations, or persons, is biomedical re- them through adoption, or carrying search or testing, when in the judg- out law enforcement, whether or not ment of the Administrator, any such the facility is operated for profit. exemption does not vitiate the purpose Primary conveyance means the main of the Act. method of transportation used to con- Retail pet store means any outlet vey an animal from origin to destina- where only the following animals are tion, such as a motor vehicle, plane, sold or offered for sale, at retail, for ship, or train. use as pets: Dogs, cats, rabbits, guinea Primary enclosure means any struc- pigs, hamsters, gerbils, rats, mice, go- ture or device used to restrict an ani- phers, chinchilla, domestic ferrets, do- mal or animals to a limited amount of mestic farm animals, birds, and cold- space, such as a room, pen, run, cage, blooded species. Such definition ex- compartment, pool, or hutch. cludes—

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(1) Establishments or persons who Study area means any building room, deal in dogs used for hunting, security, area, enclosure, or other containment or breeding purposes; outside of a core facility or centrally (2) Establishments or persons exhib- designated or managed area in which iting, selling, or offering to exhibit or animals are housed for more than 12 sell any wild or exotic or other nonpet hours. species of warmblooded animals (ex- Swim-with-the-dolphin (SWTD) pro- cept birds), such as skunks, raccoons, gram means any human-cetacean inter- nonhuman primates, squirrels, ocelots, active program in which a member of foxes, coyotes, etc.; the public enters the primary enclosure (3) Any establishment or person sell- in which an SWTD designated cetacean ing warmblooded animals (except birds, is housed to interact with the animal. and laboratory rats and mice) for re- This interaction includes, but such in- search or exhibition purposes; and clusions are not limited to, wading, (4) Any establishment wholesaling swimming, snorkeling, or scuba diving any animals (except birds, rats and in the enclosure. This interaction ex- mice). cludes, but such exclusions are not lim- (5) Any establishment exhibiting pet ited to, feeding and petting pools, and animals in a room that is separate the participation of any member(s) of from or adjacent to the retail pet store, the public audience as a minor segment or in an outside area, or anywhere off of an educational presentation or per- the retail pet store premises. formance of a show. Sanctuary area means that area in a Transporting device means an interim primary enclosure for a swim-with-the- vehicle or device, other than man, used dolphin program that is off-limits to to transport an animal between the the public and that directly abuts the primary conveyance and the terminal buffer area. facility or in and around the terminal facility of a carrier or intermediate Sanitize means to make physically handler. clean and to remove and destroy, to Transporting vehicle means any truck, the maximum degree that is practical, car, trailer, airplane, ship, or railroad agents injurious to health. car used for transporting animals. means the Secretary of Ag- Secretary Weaned means that an animal has be- riculture of the United States or his come accustomed to take solid food representative who shall be an em- and has so done, without nursing, for a ployee of the Department. period of at least 5 days. Sheltered housing facility means a Wild animal means any animal which housing facility which provides the is now or historically has been found in animals with shelter; protection from the wild, or in the wild state, within the elements; and protection from tem- the boundaries of the United States, its perature extremes at all times. A shel- territories, or possessions. This term tered housing facility may consist of includes, but is not limited to, animals runs or pens totally enclosed in a barn such as: Deer, skunk, opossum, rac- or building, or of connecting inside/out- coon, mink, armadillo, coyote, squir- side runs or pens with the inside pens rel, fox, wolf. in a totally enclosed building. Wild state means living in its origi- Standards means the requirements nal, natural condition; not domes- with respect to the humane housing, ticated. exhibition, handling, care, treatment, Zoo means any park, building, cage, temperature, and transportation of enclosure, or other structure or animals by dealers, exhibitors research premise in which a live animal or ani- facilities, carriers, intermediate han- mals are kept for public exhibition or dlers, and operators of auction sales as viewing, regardless of compensation. set forth in part 3 of this subchapter. State means a State of the United [54 FR 36119, Aug. 31, 1989, as amended at 55 States, the District of Columbia, Com- FR 12631, Apr. 5, 1990; 58 FR 39129, July 22, 1993; 62 FR 43275, Aug. 13, 1997; 63 FR 47148, monwealth of Puerto Rico, the Virgin Sept. 4, 1998; 63 FR 62926, Nov. 10, 1998; 65 FR Islands, Guam, American Samoa, or 6314, Feb. 9, 2000; 68 FR 12285, Mar. 14, 2003; 69 any other territory or possession of the FR 31514, June 4, 2004; 69 FR 42099, July 14, United States. 2004]

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EFFECTIVE DATE NOTE: At 64 FR 15920, Apr. Subpart E—Identification of Animals 2, 1999, the definitions of buffer area, interactive area, interactive session, sanctuary area, 2.50 Time and method of identification. and swim-with-the-dolphin (SWTD) program 2.51 Form of official tag. were suspended, effective Apr. 2, 1999. 2.52 How to obtain tags. 2.53 Use of tags. PART 2—REGULATIONS 2.54 Lost tags. 2.55 Removal and disposal of tags. Subpart A—Licensing Subpart F—Stolen Animals Sec. 2.60 Prohibition on the purchase, sale, use, 2.1 Requirements and application. or transportation of stolen animals. 2.2 Acknowledgement of regulations and standards. Subpart G—Records 2.3 Demonstration of compliance with standards and regulations. 2.75 Records: Dealers and exhibitors. 2.4 Non-interference with APHIS officials. 2.76 Records: Operators of auction sales and 2.5 Duration of license and termination of brokers. license. 2.77 Records: Carriers and intermediate 2.6 Annual license fees. handlers. 2.7 Annual report by licensees. 2.78 Health certification and identification. 2.8 Notification of change of name, address, 2.79 C.O.D. shipments. control, or ownership of business. 2.80 Records, disposition. 2.9 Officers, agents, and employees of licensees whose licenses have been sus- Subpart H—Compliance With Standards pended or revoked. and Holding Period 2.10 Licensees whose licenses have been suspended or revoked. 2.100 Compliance with standards. 2.11 Denial of initial license application. 2.101 Holding period. 2.12 Termination of a license. 2.102 Holding facility.

Subpart B—Registration Subpart I—Miscellaneous

2.25 Requirements and procedures. 2.125 Information as to business; furnishing 2.26 Acknowledgement of regulations and of same by dealers, exhibitors, operators standards. of auction sales, intermediate handlers, 2.27 Notification of change of operation. and carriers. 2.126 Access and inspection of records and Subpart C—Research Facilities property. 2.30 Registration. 2.127 Publication of names of persons sub- 2.31 Institutional Animal Care and Use ject to the provisions of this part. Committee (IACUC). 2.128 Inspection for missing animals. 2.32 Personnel qualifications. 2.129 Confiscation and destruction of ani- 2.33 Attending veterinarian and adequate mals. veterinary care. 2.130 Minimum age requirements. 2.34 [Reserved] 2.131 Handling of animals. 2.35 Recordkeeping requirements. 2.132 Procurement of dogs, cats, and other 2.36 Annual report. animals; dealers. 2.37 Federal research facilities. 2.133 Certification for random source dogs 2.38 Miscellaneous. and cats. 2.134 Contingency planning.

Subpart D—Attending Veterinarian and AUTHORITY: 7 U.S.C. 2131–2159; 7 CFR 2.22, Adequate Veterinary Care 2.80, and 371.7.

2.40 Attending veterinarian and adequate SOURCE: 54 FR 36147, Aug. 31, 1989, unless veterinary care (dealers and exhibitors). otherwise noted.

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Subpart A—Licensing such animals to a research facility, an exhibitor, a dealer, or a pet store dur- § 2.1 Requirements and application. ing any calendar year and is not other- (a)(1) Any person operating or intend- wise required to obtain a license; ing to operate as a dealer, exhibitor, or (iii) Any person who maintains a operator of an auction sale, except per- total of three (3) or fewer breeding fe- sons who are exempted from the licens- male dogs, cats, and/or small exotic or ing requirements under paragraph wild mammals, such as hedgehogs, (a)(3) of this section, must have a valid degus, spiny mice, prairie dogs, flying license. A person must be 18 years of squirrels, and jerboas, and who sells age or older to obtain a license. A per- only the offspring of these dogs, cats, son seeking a license shall apply on a or small exotic or wild mammals, form which will be furnished by the AC which were born and raised on his or Regional Director in the State in her premises, for pets or exhibition, which that person operates or intends and is not otherwise required to obtain to operate. The applicant shall provide a license. This exemption does not ex- the information requested on the appli- tend to any person residing in a house- cation form, including a valid mailing hold that collectively maintains a address through which the licensee or total of more than three breeding fe- applicant can be reached at all times, male dogs, cats, and/or small exotic or and a valid premises address where ani- wild mammals, regardless of owner- mals, animal facilities, equipment, and ship, nor to any person maintaining records may be inspected for compli- breeding female dogs, cats, and/or ance. The applicant shall file the com- small exotic or wild mammals on pleted application form with the AC premises on which more than three Regional Director. breeding female dogs, cats, and/or (2) If an applicant for a license or li- small exotic or wild mammals are cense renewal operates in more than maintained, nor to any person acting one State, he or she shall apply in the in concert with others where they col- State in which he or she has his or her lectively maintain a total of more than principal place of business. All prem- three breeding female dogs, cats, and/or ises, facilities, or sites where such per- small exotic or wild mammals regard- son operates or keeps animals shall be less of ownership; indicated on the application form or on a separate sheet attached to it. The (iv) Any person who sells fewer than completed application form, along with 25 dogs and/or cats per year, which the application fee indicated in para- were born and raised on his or her graph (c) of this section, and the an- premises, for research, teaching, or nual license fee indicated in table 1 or testing purposes or to any research fa- 2 of § 2.6 shall be filed with the AC Re- cility and is not otherwise required to gional Director. obtain a license. This exemption does (3) The following persons are exempt not extend to any person residing in a from the licensing requirements under household that collectively sells 25 or section 2 or section 3 of the Act: more dogs and/or cats, regardless of (i) Retail pet stores which sell non- ownership, nor to any person acting in dangerous, pet-type animals, such as concert with others where they collec- dogs, cats, birds, rabbits, hamsters, tively sell 25 or more dogs and/or cats, guinea pigs, gophers, domestic ferrets, regardless of ownership. The sale of chinchilla, rats, and mice, for pets, at any dog or cat not born and raised on retail only: Provided, That, Anyone the premises for research purposes re- wholesaling any animals, selling any quires a license; animals for research or exhibition, or (v) Any person who arranges for selling any wild, exotic, or nonpet ani- transportation or transports animals mals retail, must have a license; solely for the purpose of breeding, ex- (ii) Any person who sells or nego- hibiting in purebred shows, boarding tiates the sale or purchase of any ani- (not in association with commercial mal except wild or exotic animals, transportation), grooming, or medical dogs, or cats, and who derives no more treatment, and is not otherwise re- than $500 gross income from the sale of quired to obtain a license;

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(vi) Any person who buys, sells, The applicant may pay the fee by cer- transports, or negotiates the sale, pur- tified check, cashier’s check, personal chase, or transportation of any animals check, money order, or credit card. An used only for the purposes of food or applicant whose check is returned by a fiber (including fur); bank will be charged a fee of $20 for (vii) Any person who breeds and each returned check. If an applicant’s raises domestic pet animals for direct check is returned, subsequent fees retail sales to another person for the must be paid by certified check, cash- buyer’s own use and who buys no ani- ier’s check, or money order. mals for resale and who sells no ani- (e) The failure of any person to com- mals to a research facility, an exhibi- ply with any provision of the Act, or tor, a dealer, or a pet store (e.g., a any of the provisions of the regulations purebred dog or cat fancier) and is not or standards in this subchapter, shall otherwise required to obtain a license; constitute grounds for denial of a li- (viii) Any person who buys animals cense; or for its suspension or revoca- solely for his or her own use or enjoy- tion by the Secretary, as provided in ment and does not sell or exhibit ani- the Act. mals, or is not otherwise required to obtain a license; (Approved by the Office of Management and (b) No person shall have more than Budget under control number 0579–0254) one license. [54 FR 36147, Aug. 31, 1989, as amended at 63 (c) A license will be issued to any ap- FR 62926, Nov. 10, 1998; 69 FR 42099, July 14, plicant, except as provided in §§ 2.10 and 2004] 2.11, when: (1) The applicant has met the re- § 2.2 Acknowledgement of regulations quirements of this section and §§ 2.2 and standards. and 2.3; and (a) Application for initial license. (2) The applicant has paid the appli- APHIS will supply a copy of the application fee of $10 and the annual license cable regulations and standards to the fee indicated in § 2.6 to the appropriate applicant with each request for a li- Animal Care regional office for an ini- cense application. The applicant shall tial license, and, in the case of a li- acknowledge receipt of the regulations cense renewal, the annual license fee and standards and agree to comply has been received by the appropriate with them by signing the application Animal Care regional office on or be- form before a license will be issued. fore the expiration date of the license. (b) Application for license renewal. (d)(1) A licensee who wishes a re- APHIS will renew a license after the newal must submit to the appropriate applicant certifies by signing the appli- Animal Care regional office a com- cation form that, to the best of the ap- pleted application form and the annual plicant’s knowledge and belief, he or license fee indicated in § 2.6 by certified she is in compliance with the regula- check, cashier’s check, personal check, tions and standards and agrees to con- money order, or credit card. The appli- tinue to comply with the regulations cation form and the annual license fee and standards. APHIS will supply a must be received by the appropriate copy of the applicable regulations and Animal Care regional office on or be- standards to the applicant upon re- fore the expiration date of the license. quest. An applicant whose check is returned by the bank will be charged a fee of $20 (Approved by the Office of Management and Budget under control number 0579–0254) for each returned check. A returned check will be deemed nonpayment of [60 FR 13895, Mar. 15, 1995, as amended at 69 fee and will result in the denial of the FR 42100, July 14, 2004] license. If an applicant’s check is returned, subsequent fees must be paid § 2.3 Demonstration of compliance by certified check, cashier’s check, or with standards and regulations. money order. (a) Each applicant must demonstrate (2) A license fee indicated in § 2.6 that his or her premises and any ani- must also be paid if an applicant is ap- mals, facilities, vehicles, equipment, or plying for a changed class of license. other premises used or intended for use

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in the business comply with the regula- en, abuse (including verbally abuse), or tions and standards set forth in parts 2 harass any APHIS official in the course and 3 of this subchapter. Each appli- of carrying out his or her duties. cant for an initial license or license renewal must make his or her animals, § 2.5 Duration of license and termi- premises, facilities, vehicles, equip- nation of license. ment, other premises, and records (a) A license issued under this part available for inspection during busi- shall be valid and effective unless: ness hours and at other times mutually (1) The license has been revoked or agreeable to the applicant and APHIS, to ascertain the applicant’s compliance suspended pursuant to section 19 of the with the standards and regulations. Act. (b) Each applicant for an initial li- (2) The license is voluntarily termi- cense must be inspected by APHIS and nated upon request of the licensee, in demonstrate compliance with the regu- writing, to the AC Regional Director. lations and standards, as required in (3) The license has expired or been paragraph (a) of this section, before terminated under this part. APHIS will issue a license. If the first (4) The annual license fee has not inspection reveals that the applicant’s been paid to the appropriate Animal animals, premises, facilities, vehicles, Care regional office as required. There equipment, other premises, or records will not be a refund of the annual li- do not meet the requirements of this cense fee if a license is terminated subchapter, APHIS will advise the ap- prior to its expiration date. plicant of existing deficiencies and the (b) Any person who is licensed must corrective measures that must be completed to come into compliance with file an application for a license renewal the regulations and standards. An ap- and an annual report form (APHIS plicant who fails the first inspection Form 7003), as required by § 2.7 of this will have two additional chances to part, and pay the required annual li- demonstrate his or her compliance cense fee. The required annual license with the regulations and standards fee must be received in the appropriate through a second inspection by APHIS. Animal Care regional office on or be- The applicant must request the second fore the expiration date of the license inspection, and if applicable, the third or the license will expire and automati- inspection, within 90 days following the cally terminate. Failure to comply first inspection. If the applicant fails with the annual reporting require- inspection or fails to request reinspec- ments or pay the required annual li- tions within the 90-day period, he or cense fee on or before the expiration she will forfeit the application fee and date of the license will result in auto- cannot reapply for a license for a pe- matic termination of the license. riod of 6 months from the date of the (c) Any person who seeks the rein- failed third inspection or the expira- statement of a license that has been tion of the time to request a third in- automatically terminated must follow spection. Issuance of a license will be denied until the applicant dem- the procedure applicable to new appli- onstrates upon inspection that the ani- cants for a license set forth in § 2.1. mals, premises, facilities, vehicles, (d) Licenses are issued to specific equipment, other premises, and records persons for specific premises and do not are in compliance with all regulations transfer upon change of ownership, nor and standards in this subchapter. are they valid at a different location. (e) A license which is invalid under (Approved by the Office of Management and Budget under control number 0579–0254) this part shall be surrendered to the AC Regional Director. If the license [54 FR 36147, Aug. 31, 1989, as amended at 69 cannot be found, the licensee shall pro- FR 42100, July 14, 2004] vide a written statement so stating to § 2.4 Non-interference with APHIS offi- the AC Regional Director. cials. [54 FR 36147, Aug. 31, 1989, as amended at 60 A licensee or applicant for an initial FR 13895, Mar. 15, 1995; 63 FR 62926, Nov. 10, license shall not interfere with, threat- 1998; 69 FR 42100, July 14, 2004]

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§ 2.6 Annual license fees. see shall each pay a fee based on the net compensation received from the (a) For an initial license, the appli- leased animals calculated from Table 1 cant must submit a $10 application fee in addition to the initial license fee in paragraph (c) of this section. prescribed in this section. Licensees (3) The annual license renewal fee for applying for license renewal or changed a broker or operator of an auction sale class of license must submit only the shall be that of a class ‘‘B’’ dealer and license fee prescribed in this section. shall be based on the total gross The license fee for an initial license, li- amount, expressed in dollars, derived cense renewal, or changed class of li- from commissions or fees charged for cense is determined from table 1 or 2 in the sale of animals, or for negotiating paragraph (c) of this section. Para- the sale of animals, by brokers or by graph (b) of this section indicates the the operator of an auction sale, to re- method used to calculate the license search facilities, dealers, exhibitors, fee. All initial license and changed retail pet stores, and persons for use as class of license fees must be submitted pets, during the preceding business to the appropriate Animal Care re- year (calendar or fiscal). gional office, and, in the case of license (4) In the case of a new applicant for renewals, all fees must be received by a license as a dealer, broker or oper- the appropriate Animal Care regional ator of an auction sale who did not op- office on or before the expiration date erate during a preceding business year, of the license. the annual license fee will be based on (b)(1) Class ‘‘A’’ license. The annual the anticipated yearly dollar amount license renewal fee for a Class ‘‘A’’ of business, as provided in paragraphs dealer shall be based on 50 percent of (b)(1), (2), and (3) of this section, de- the total gross amount, expressed in dollars, derived from the sale of ani- rived from the sale of animals to re- mals to research facilities, dealers, ex- search facilities, dealers, exhibitors, hibitors, retail pet stores, and persons retail pet stores, and persons for use as for use as pets, directly or through an pets, directly or through an auction auction sale, by the dealer or applicant sale. during his or her preceding business (5) The amount of the annual fee to year (calendar or fiscal) in the case of be paid upon application for a class a person who operated during such a ‘‘C’’ license as an exhibitor under this year. If animals are leased, the lessor section shall be based on the number of shall pay a fee based on 50 percent of animals which the exhibitor owned, any compensation received from the held, or exhibited at the time the ap- leased animals and the lessee shall pay plication is signed and dated or during a fee based upon the net compensation the previous year, whichever is greater, received from the leased animals, as in- and will be the amount listed in Table dicated for dealers in Table 1 in para- 2 in paragraph (c) of this section. Ani- graph (c) of this section. mals which are leased shall be included (2) Class ‘‘B’’ license. The annual li- in the number of animals being held by cense renewal fee for a Class ‘‘B’’ deal- both the lessor and the lessee when cal- er shall be established by calculating culating the annual fee. An exhibitor the total amount received from the shall pay his or her annual license fee sale of animals to research facilities, on or before the expiration date of the dealers, exhibitors, retail pet stores, license and the fee shall be based on and persons for use as pets, directly or the number of animals which the ex- through an auction sale, during the hibitor is holding or has held during preceding business year (calendar or fiscal) less the amount paid for the ani- the year (both owned and leased). mals by the dealer or applicant. This (c) The license fee shall be computed net difference, exclusive of other costs, in accordance with the following ta- shall be the figure used to determine bles: the license fee of a Class ‘‘B’’ dealer. If animals are leased, the lessor and les-

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TABLE 1—DEALERS, BROKERS, AND OPERATORS § 2.7 Annual report by licensees. OF AN AUCTION SALE—CLASS ‘‘A’’ AND ‘‘B’’ (a) Each year, within 30 days prior to LICENSE the expiration date of his or her li- Annual or cense, a licensee shall file with the AC But not Initial changed Over over license class of Regional Director an application for li- fee license fee cense renewal and annual report upon a form which the AC Regional Director $0 ...... $500 $30 $40 500 ...... 2,000 60 70 will furnish to him or her upon request. 2,000 ...... 10,000 120 130 (b) A person licensed as a dealer shall 10,000 ...... 25,000 225 235 set forth in his or her license renewal 25,000 ...... 50,000 350 360 application and annual report the dol- 50,000 ...... 100,000 475 485 100,000 ...... 750 760 lar amount of business, from the sale of animals, upon which the license fee is based, directly or through an auction TABLE 2—EXHIBITORS—CLASS ‘‘C’’ LICENSE sale, to research facilities, dealers, ex- Annual or hibitors, retail pet stores, and persons Initial changed Number of animals license class of li- for use as pets, by the licensee during fee cense fee the preceding business year (calendar 1 to 5 ...... $30 $40 or fiscal), and any other information as 6 to 25 ...... 75 85 may be required thereon. 26 to 50 ...... 175 185 (c) A licensed dealer who operates as 51 to 500 ...... 225 235 a broker or an operator of an auction 501 and up ...... 300 310 sale shall set forth in his or her license (d) If a person meets the licensing re- renewal application and annual report quirements for more than one class of the total gross amount, expressed in license, he shall be required to obtain a dollars, derived from commissions or license and pay the fee for the type fees charged for the sale of animals by business which is predominant for his the licensee to research facilities, deal- operation, as determined by the Sec- ers, exhibitors, retail pet stores, and retary. persons for use as pets, during the pre- (e) In any situation in which a li- ceding business year (calendar or fis- censee shall have demonstrated in cal), and any other information as may writing to the satisfaction of the Sec- be required thereon. retary that he or she has good reason (d) A person licensed as an exhibitor to believe that the dollar amount of his shall set forth in his or her license re- or her business for the forthcoming newal application and annual report business year will be less than the pre- the number of animals owned, held, or vious business year, then his or her es- exhibited by him or her, including timated dollar amount of business those which are leased, during the pre- shall be used for computing the license vious year or at the time he signs and fee for the forthcoming business year: dates the report, whichever is greater. Provided, however, That if the dollar amount upon which the license fee is [54 FR 36147, Aug. 31, 1989, as amended at 63 based for that year does in fact exceed FR 62926, Nov. 10, 1998] the amount estimated, the difference § 2.8 Notification of change of name, in amount of the fee paid and that address, control, or ownership of which was due under paragraphs (b) business. and (c) of this section based upon the actual dollar business upon which the A licensee shall promptly notify the license fee is based, shall be payable in AC Regional Director by certified mail addition to the required annual license of any change in the name, address, fee for the next subsequent year, on the management, or substantial control or anniversary date of his or her license ownership of his business or operation, as prescribed in this section. or of any additional sites, within 10 days of any change. [54 FR 36147, Aug. 31, 1989, as amended at 63 FR 62926, Nov. 10, 1998; 69 FR 42101, July 14, [54 FR 36147, Aug. 31, 1989, as amended at 63 2004] FR 62926, Nov. 10, 1998]

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§ 2.9 Officers, agents, and employees of (2) Is not in compliance with any of licensees whose licenses have been the regulations or standards in this suspended or revoked. subchapter; Any person who has been or is an of- (3) Has had a license revoked or ficer, agent, or employee of a licensee whose license is suspended, as set forth whose license has been suspended or rein § 2.10; voked and who was responsible for or (4) Has pled nolo contendere (no con- participated in the violation upon test) or has been found to have violated which the order of suspension or rev- any Federal, State, or local laws or ocation was based will not be licensed regulations pertaining to animal cru- within the period during which the elty within 1 year of application, or order of suspension or revocation is in after 1 year if the Administrator deter- effect. mines that the circumstances render the applicant unfit to be licensed; § 2.10 Licensees whose licenses have (5) Is or would be operating in viola- been suspended or revoked. tion or circumvention of any Federal, (a) Any person whose license has State, or local laws; or been suspended for any reason shall not (6) Has made any false or fraudulent be licensed in his or her own name or statements or provided any false or in any other manner within the period fraudulent records to the Department during which the order of suspension is or other government agencies, or has in effect. No partnership, firm, corpora- pled nolo contendere (no contest) or has tion, or other legal entity in which any been found to have violated any Fed- such person has a substantial interest, eral, State, or local laws or regulations financial or otherwise, will be licensed pertaining to the transportation, own- during that period. Any person whose ership, neglect, or welfare of animals, license has been suspended for any rea- or is otherwise unfit to be licensed and son may apply to the AC Regional Di- the Administrator determines that the rector, in writing, for reinstatement of issuance of a license would be contrary his or her license. No license will be re- to the purposes of the Act. newed during the period that it is suspended. Renewal of the license may be (b) An applicant whose license appli- initiated during the suspension in ac- cation has been denied may request a cordance with §§ 2.2(b) and 2.12. hearing in accordance with the applica- (b) Any person whose license has ble rules of practice for the purpose of been revoked shall not be licensed in showing why the application for license his or her own name or in any other should not be denied. The license de- manner; nor will any partnership, firm, nial shall remain in effect until the corporation, or other legal entity in final legal decision has been rendered. which any such person has a substan- Should the license denial be upheld, tial interest, financial or otherwise, be the applicant may again apply for a li- licensed. cense 1 year from the date of the final (c) Any person whose license has been order denying the application, unless suspended or revoked shall not buy, the order provides otherwise. sell, transport, exhibit, or deliver for (c) No partnership, firm, corporation, transportation, any animal during the or other legal entity in which a person period of suspension or revocation. whose license application has been denied has a substantial interest, finan- [54 FR 36147, Aug. 31, 1989, as amended at 63 cial or otherwise, will be licensed with- FR 62926, Nov. 10, 1998; 69 FR 42101, July 14, in 1 year of the license denial. 2004] (d) No license will be issued under § 2.11 Denial of initial license applica- circumstances that the Administrator tion. determines would circumvent any (a) A license will not be issued to any order suspending, revoking, termi- applicant who: nating, or denying a license under the (1) Has not complied with the re- Act. quirements of §§ 2.1, 2.2, 2.3, and 2.4 and [54 FR 36147, Aug. 31, 1989, as amended at 69 has not paid the fees indicated in § 2.6; FR 42101, July 14, 2004]

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§ 2.12 Termination of a license. APHIS, and by filing it with the AC Regional Director. A license may be terminated during the license renewal process or at any [54 FR 36147, Aug. 31, 1989, as amended at 63 other time for any reason that an ini- FR 62926, Nov. 10, 1998] tial license application may be denied pursuant to § 2.11 after a hearing in ac- § 2.27 Notification of change of operation. cordance with the applicable rules of practice. (a) A registrant shall notify the AC Regional Director by certified mail of [69 FR 42101, July 14, 2004] any change in the name, address, or ownership, or other change in oper- Subpart B—Registration ations affecting its status as an exhibitor, carrier, or intermediate handler, § 2.25 Requirements and procedures. within 10 days after making such (a) Each carrier and intermediate change. handler, and each exhibitor not re- (b)(1) A registrant which has not quired to be licensed under section 3 of used, handled, or transported animals the Act and the regulations of this sub- for a period of at least 2 years may be chapter, shall register with the Sec- placed in an inactive status by making retary by completing and filing a prop- a written request to the AC Regional erly executed form which will be fur- Director a registrant shall notify the nished, upon request, by the AC Re- AC Regional Director in writing at gional Director. The registration form least 10 days before using, handling, or shall be filed with the AC Regional Di- transporting animals again after being rector for the State in which the reg- in an inactive status. istrant has his or her principal place of (2) A registrant which goes out of business, and shall be updated every 3 business or which ceases to function as years by the completion and filing of a a carrier, intermediate handler, or ex- new registration form which will be hibitor, or which changes its method of provided by the AC Regional Director. operation so that it no longer uses, (b) A subsidiary of a business cor- handles, or transports animals, and poration, rather than the parent cor- which does not plan to use, handle, or poration, will be registered as an ex- transport animals again at any time in hibitor unless the subsidiary is under the future, may have its registration such direct control of the parent cor- canceled by making a written request poration that the Secretary determines to the AC Regional Director. The that it is necessary that the parent former registrant is responsible for re- corporation be registered to effectuate registering and demonstrating its com- the purposes of the Act. pliance with the Act and regulations (c) No registrant or person required should it start using, handling, or to be registered shall interfere with, transporting animals at any time after threaten, abuse (including verbally its registration is canceled. abuse), or harass any APHIS official [54 FR 36147, Aug. 31, 1989, as amended at 63 who is in the course of carrying out his FR 62926, Nov. 10, 1998] or her duties. [54 FR 36147, Aug. 31, 1989, as amended at 63 Subpart C—Research Facilities FR 62926, Nov. 10, 1998; 69 FR 42101, July 14, 2004] § 2.30 Registration. (a) Requirements and procedures. (1) § 2.26 Acknowledgment of regulations Each research facility other than a and standards. Federal research facility, shall register APHIS will supply a copy of the regu- with the Secretary by completing and lations and standards in this sub- filing a properly executed form which chapter with each registration form. will be furnished, upon request, by the The registrant shall acknowledge re- AC Regional Director. The registration ceipt of and shall agree to comply with form shall be filed with the AC Re- the regulations and standards by sign- gional Director for the State in which ing a form provided for this purpose by the research facility has its principal

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place of business, and shall be updated inactive). A research facility shall no- every 3 years by the completion and fil- tify the AC Regional Director in writing of a new registration form which ing at least 10 days before using, han- will be provided by the AC Regional Di- dling, or transporting animals again rector. Except as provided in paragraph after being in an inactive status. (a)(2) of this section, where a school or (3) A research facility which goes out department of a university or college of business or which ceases to function uses or intends to use live animals for as a research facility, or which changes research, tests, experiments, or teach- its method of operation so that it no ing, the university or college rather longer uses, handles, or transports ani- than the school or department will be mals, and which does not plan to use, considered the research facility and handle, or transport animals at any will be required to register with the time in the future, may have its reg- Secretary. An official who has the legal istration canceled by making a written authority to bind the parent organiza- request to the AC Regional Director. tion shall sign the registration form. The research facility is responsible for (2) In any situation in which a school reregistering and demonstrating its or department of a university or col- compliance with the Act and regula- lege demonstrates to the Secretary tions should it start using, handling, or that it is a separate legal entity and its transporting animals at any time after operations and administration are its registration is canceled. independent of those of the university (d) No research facility shall inter- or college, the school or department fere with, threaten, abuse (including will be registered rather than the uni- verbally abuse), or harass any APHIS versity or college. official who is in the course of carrying (3) A subsidiary of a business cor- out his or her duties. poration, rather than the parent cor- [54 FR 36147, Aug. 31, 1989, as amended at 63 poration, will be registered as a re- FR 62926, Nov. 10, 1998; 69 FR 42101, July 14, search facility unless the subsidiary is 2004] under such direct control of the parent corporation that the Secretary deter- § 2.31 Institutional Animal Care and mines that it is necessary that the par- Use Committee (IACUC). ent corporation be registered to effec- (a) The Chief Executive Officer of the tuate the purposes of the Act. research facility shall appoint an Insti- (b) Acknowledgment of regulations and tutional Animal Care and Use Com- standards. APHIS will supply a copy of mittee (IACUC), qualified through the the regulations and standards in this experience and expertise of its mem- subchapter with each registration bers to assess the research facility’s form. The research facility shall ac- animal program, facilities, and proce- knowledge receipt of and shall agree to dures. Except as specifically authorized comply with the regulations and stand- by law or these regulations, nothing in ards by signing a form provided for this this part shall be deemed to permit the purpose by APHIS, and by filing it with Committee or IACUC to prescribe the AC Regional Director. methods or set standards for the de- (c) Notification of change of operation. sign, performance, or conduct of actual (1) A research facility shall notify the research or experimentation by a re- AC Regional Director by certified mail search facility. of any change in the name, address, or (b) IACUC membership. (1) The mem- ownership, or other change in oper- bers of each Committee shall be ap- ations affecting its status as a research pointed by the Chief Executive Officer facility, within 10 days after making of the research facility; such change. (2) The Committee shall be composed (2) A research facility which has not of a Chairman and at least two addi- used, handled, or transported animals tional members; for a period of at least 2 years may be (3) Of the members of the Committee: placed in an inactive status by making (i) At least one shall be a Doctor of a written request to the AC Regional Veterinary Medicine, with training or Director. A research facility shall file experience in laboratory animal an annual report of its status (active or science and medicine, who has direct or

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delegated program responsibility for minority views. The reports shall be activities involving animals at the re- updated at least once every six months search facility; upon completion of the required semi- (ii) At least one shall not be affili- annual evaluations and shall be main- ated in any way with the facility other tained by the research facility and than as a member of the Committee, made available to APHIS and to offi- and shall not be a member of the im- cials of funding Federal agencies for in- mediate family of a person who is af- spection and copying upon request. The filiated with the facility. The Sec- reports must contain a description of retary intends that such person will the nature and extent of the research provide representation for general facility’s adherence to this subchapter, community interests in the proper care must identify specifically any depar- and treatment of animals; tures from the provisions of title 9, (4) If the Committee consists of more chapter I, subchapter A—Animal Wel- than three members, not more than fare, and must state the reasons for three members shall be from the same each departure. The reports must dis- administrative unit of the facility. tinguish significant deficiencies from (c) IACUC functions. With respect to minor deficiencies. A significant defi- activities involving animals, the ciency is one which, with reference to IACUC, as an agent of the research fa- Subchapter A, and, in the judgment of cility, shall: the IACUC and the Institutional Offi- (1) Review, at least once every six cial, is or may be a threat to the health months, the research facility’s pro- or safety of the animals. If program or gram for humane care and use of ani- facility deficiencies are noted, the re- mals, using title 9, chapter I, sub- ports must contain a reasonable and chapter A—Animal Welfare, as a basis specific plan and schedule with dates for evaluation; for correcting each deficiency. Any (2) Inspect, at least once every six failure to adhere to the plan and sched- months, all of the research facility’s ule that results in a significant defi- animal facilities, including animal ciency remaining uncorrected shall be study areas, using title 9, chapter I, reported in writing within 15 business subchapter A-Animal Welfare, as a days by the IACUC, through the Insti- basis for evaluation; Provided, however, tutional Official, to APHIS and any That animal areas containing free-liv- Federal agency funding that activity; ing wild animals in their natural habi- (4) Review, and, if warranted, inves- tat need not be included in such inspec- tigate concerns involving the care and tion; use of animals at the research facility (3) Prepare reports of its evaluations resulting from public complaints re- conducted as required by paragraphs (c)(1) and (2) of this section, and submit ceived and from reports of noncompli- the reports to the Institutional Official ance received from laboratory or re- of the research facility; Provided, how- search facility personnel or employees; ever, That the IACUC may determine (5) Make recommendations to the In- the best means of conducting evalua- stitutional Official regarding any as- tions of the research facility’s pro- pect of the research facility’s animal grams and facilities; and Provided, fur- program, facilities, or personnel train- ther, That no Committee member wishing; ing to participate in any evaluation (6) Review and approve, require modi- conducted under this subpart may be fications in (to secure approval), or excluded. The IACUC may use sub- withhold approval of those components committees composed of at least two of proposed activities related to the Committee members and may invite ad care and use of animals, as specified in hoc consultants to assist in conducting paragraph (d) of this section; the evaluations, however, the IACUC (7) Review and approve, require modi- remains responsible for the evaluations fications in (to secure approval), or and reports as required by the Act and withhold approval of proposed signifi- regulations. The reports shall be re- cant changes regarding the care and viewed and signed by a majority of the use of animals in ongoing activities; IACUC members and must include any and

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(8) Be authorized to suspend an activ- (vi) The animals’ living conditions ity involving animals in accordance will be appropriate for their species in with the specifications set forth in accordance with part 3 of this subparagraph (d)(6) of this section. chapter, and contribute to their health (d) IACUC review of activities involv- and comfort. The housing, feeding, and ing animals. (1) In order to approve nonmedical care of the animals will be proposed activities or proposed signifi- directed by the attending veterinarian cant changes in ongoing activities, the or other scientist trained and experi- IACUC shall conduct a review of those enced in the proper care, handling, and components of the activities related to use of the species being maintained or the care and use of animals and deter- studied; mine that the proposed activities are (vii) Medical care for animals will be in accordance with this subchapter unavailable and provided as necessary by less acceptable justification for a de- a qualified veterinarian; parture is presented in writing; Pro- (viii) Personnel conducting proce- vided, however, That field studies as de- dures on the species being maintained fined in part 1 of this subchapter are or studied will be appropriately quali- exempt from this requirement. Fur- fied and trained in those procedures; ther, the IACUC shall determine that (ix) Activities that involve surgery the proposed activities or significant include appropriate provision for pre- changes in ongoing activities meet the operative and post-operative care of following requirements: the animals in accordance with estab- (i) Procedures involving animals will lished veterinary medical and nursing avoid or minimize discomfort, distress, practices. All survival surgery will be and pain to the animals; performed using aseptic procedures, in- (ii) The principal investigator has cluding surgical gloves, masks, sterile considered alternatives to procedures instruments, and aseptic techniques. that may cause more than momentary Major operative procedures on non-ro- or slight pain or distress to the ani- dents will be conducted only in facili- mals, and has provided a written nar- ties intended for that purpose which rative description of the methods and shall be operated and maintained under sources, e. g., the Animal Welfare Infor- aseptic conditions. Non-major opera- mation Center, used to determine that tive procedures and all surgery on ro- alternatives were not available; dents do not require a dedicated facil- (iii) The principal investigator has ity, but must be performed using asep- provided written assurance that the ac- tic procedures. Operative procedures tivities do not unnecessarily duplicate conducted at field sites need not be previous experiments; performed in dedicated facilities, but (iv) Procedures that may cause more must be performed using aseptic proce- than momentary or slight pain or dis- dures; tress to the animals will: (x) No animal will be used in more (A) Be performed with appropriate than one major operative procedure sedatives, analgesics or anesthetics, from which it is allowed to recover, un- unless withholding such agents is justi- less: fied for scientific reasons, in writing, (A) Justified for scientific reasons by by the principal investigator and will the principal investigator, in writing; continue for only the necessary period (B) Required as routine veterinary of time; procedure or to protect the health or (B) Involve, in their planning, con- well-being of the animal as determined sultation with the attending veteri- by the attending veterinarian; or narian or his or her designee; (C) In other special circumstances as (C) Not include the use of paralytics determined by the Administrator on an without anesthesia; individual basis. Written requests and (v) Animals that would otherwise ex- supporting data should be sent to the perience severe or chronic pain or dis- Animal and Plant Health Inspection tress that cannot be relieved will be Service, Animal Care, 4700 River Road, painlessly euthanized at the end of the Unit 84, Riverdale, Maryland 20737–1234; procedure or, if appropriate, during the (xi) Methods of euthanasia used must procedure; be in accordance with the definition of

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the term set forth in 9 CFR part 1, § 1.1 its decision, with documentation in of this subchapter, unless a deviation is Committee minutes, in light of the in- justified for scientific reasons, in writ- formation provided by the principal ining, by the investigator. vestigator; (2) Prior to IACUC review, each mem- (5) The IACUC shall conduct con- ber of the Committee shall be provided tinuing reviews of activities covered by with a list of proposed activities to be this subchapter at appropriate inter- reviewed. Written descriptions of all vals as determined by the IACUC, but proposed activities that involve the not less than annually; care and use of animals shall be avail- (6) The IACUC may suspend an activ- able to all IACUC members, and any ity that it previously approved if it de- member of the IACUC may obtain, termines that the activity is not being upon request, full Committee review of conducted in accordance with the de- those activities. If full Committee re- scription of that activity provided by view is not requested, at least one the principal investigator and approved member of the IACUC, designated by by the Committee. The IACUC may the chairman and qualified to conduct suspend an activity only after review the review, shall review those activi- of the matter at a convened meeting of ties, and shall have the authority to a quorum of the IACUC and with the approve, require modifications in (to suspension vote of a majority of the secure approval), or request full Com- quorum present; mittee review of any of those activi- (7) If the IACUC suspends an activity ties. If full Committee review is re- involving animals, the Institutional Of- quested for a proposed activity, ap- ficial, in consultation with the IACUC, proval of that activity may be granted shall review the reasons for suspension, only after review, at a convened meet- take appropriate corrective action, and ing of a quorum of the IACUC, and with report that action with a full expla- the approval vote of a majority of the nation to APHIS and any Federal agen- quorum present. No member may par- cy funding that activity; and ticipate in the IACUC review or ap- (8) Proposed activities and proposed proval of an activity in which that significant changes in ongoing activi- member has a conflicting interest (e.g., ties that have been approved by the is personally involved in the activity), IACUC may be subject to further ap- except to provide information re- propriate review and approval by offi- quested by the IACUC, nor may a mem- cials of the research facility. However, ber who has a conflicting interest con- those officials may not approve an ac- tribute to the constitution of a tivity involving the care and use of quorum; animals if it has not been approved by (3) The IACUC may invite consult- the IACUC. ants to assist in the review of complex (e) A proposal to conduct an activity issues arising out of its review of pro- involving animals, or to make a sig- posed activities. Consultants may not nificant change in an ongoing activity approve or withhold approval of an ac- involving animals, must contain the tivity, and may not vote with the following: IACUC unless they are also members of (1) Identification of the species and the IACUC; the approximate number of animals to (4) The IACUC shall notify principal be used; investigators and the research facility (2) A rationale for involving animals, in writing of its decision to approve or and for the appropriateness of the spe- withhold approval of those activities cies and numbers of animals to be used; related to the care and use of animals, (3) A complete description of the pro- or of modifications required to secure posed use of the animals; IACUC approval. If the IACUC decides (4) A description of procedures de- to withhold approval of an activity, it signed to assure that discomfort and shall include in its written notification pain to animals will be limited to that a statement of the reasons for its deci- which is unavoidable for the conduct of sion and give the principal investigator scientifically valuable research, includ- an opportunity to respond in person or ing provision for the use of analgesic, in writing. The IACUC may reconsider anesthetic, and tranquilizing drugs

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where indicated and appropriate to (5) Utilization of services (e.g., Na- minimize discomfort and pain to ani- tional Agricultural Library, National mals; and Library of Medicine) available to pro- (5) A description of any euthanasia vide information: method to be used. (i) On appropriate methods of animal care and use; [54 FR 36147, August 31, 1989, as amended by (ii) On alternatives to the use of live 59 FR 67611, Dec. 30, 1994; 63 FR 62926, Nov. 10, 1998] animals in research; (iii) That could prevent unintended § 2.32 Personnel qualifications. and unnecessary duplication of research involving animals; and (a) It shall be the responsibility of (iv) Regarding the intent and require- the research facility to ensure that all ments of the Act. scientists, research technicians, animal technicians, and other personnel § 2.33 Attending veterinarian and ade- involved in animal care, treatment, quate veterinary care. and use are qualified to perform their (a) Each research facility shall have duties. This responsibility shall be ful- an attending veterinarian who shall filled in part through the provision of provide adequate veterinary care to its training and instruction to those per- animals in compliance with this sec- sonnel. tion: (b) Training and instruction shall be (1) Each research facility shall em- made available, and the qualifications ploy an attending veterinarian under of personnel reviewed, with sufficient formal arrangements. In the case of a frequency to fulfill the research facili- part-time attending veterinarian or ty’s responsibilities under this section consultant arrangements, the formal and § 2.31. arrangements shall include a written (c) Training and instruction of per- program of veterinary care and regu- sonnel must include guidance in at larly scheduled visits to the research least the following areas: facility; (1) Humane methods of animal main- (2) Each research facility shall assure tenance and experimentation, includ- that the attending veterinarian has ap- ing: propriate authority to ensure the pro- (i) The basic needs of each species of vision of adequate veterinary care and animal; to oversee the adequacy of other as- (ii) Proper handling and care for the pects of animal care and use; and various species of animals used by the (3) The attending veterinarian shall facility; be a voting member of the IACUC; Pro- (iii) Proper pre-procedural and post- vided, however, That a research facility procedural care of animals; and with more than one Doctor of Veteri- (iv) Aseptic surgical methods and nary Medicine (DVM) may appoint to procedures; the IACUC another DVM with dele- (2) The concept, availability, and use gated program responsibility for ac- of research or testing methods that tivities involving animals at the re- limit the use of animals or minimize search facility. animal distress; (b) Each research facility shall estab- (3) Proper use of anesthetics, analge- lish and maintain programs of ade- sics, and tranquilizers for any species quate veterinary care that include: of animals used by the facility; (1) The availability of appropriate fa- (4) Methods whereby deficiencies in cilities, personnel, equipment, and animal care and treatment are re- services to comply with the provisions ported, including deficiencies in animal of this subchapter; care and treatment reported by any (2) The use of appropriate methods to employee of the facility. No facility prevent, control, diagnose, and treat employee, Committee member, or lab- diseases and injuries, and the avail- oratory personnel shall be discrimi- ability of emergency, weekend, and nated against or be subject to any re- holiday care; prisal for reporting violations of any (3) Daily observation of all animals regulation or standards under the Act; to assess their health and well-being;

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Provided, however, That daily observa- (2) The USDA license or registration tion of animals may be accomplished number of the person if he or she is li- by someone other than the attending censed or registered under the Act; veterinarian; and Provided, further, (3) The vehicle license number and That a mechanism of direct and fre- State, and the driver’s license number quent communication is required so (or photographic identification card for that timely and accurate information nondrivers issued by a State) and State on problems of animal health, behav- of the person, if he or she is not li- ior, and well-being is conveyed to the censed or registered under the Act; attending veterinarian; (4) The date of acquisition of each (4) Guidance to principal investiga- dog or cat; tors and other personnel involved in (5) The official USDA tag number or the care and use of animals regarding tattoo assigned to each dog or cat handling, immobilization, anesthesia, under § 2.38(g) of this subpart; analgesia, tranquilization, and euthanasia; and (6) A description of each dog or cat (5) Adequate pre-procedural and post- which shall include: procedural care in accordance with cur- (i) The species and breed or type of rent established veterinary medical animal; and nursing procedures. (ii) The sex; (iii) The date of birth or approximate § 2.34 [Reserved] age; and (iv) The color and any distinctive § 2.35 Recordkeeping requirements. markings; (a) The research facility shall main- (7) Any identification number or tain the following IACUC records: mark assigned to each dog or cat by (1) Minutes of IACUC meetings, in- the research facility; cluding records of attendance, activi- (8) If dogs or cats are acquired from ties of the Committee, and Committee any person not licensed or registered deliberations; under the Act and not a pound or shel- (2) Records of proposed activities inter, the research facility must obtain a volving animals and proposed signifi- certification that the animals were cant changes in activities involving born and raised on the person’s prem- animals, and whether IACUC approval ises and that the person has sold fewer was given or withheld; and than 25 dogs and/or cats that year. (3) Records of semiannual IACUC re- (c) In addition to the information reports and recommendations (including quired to be kept and maintained by minority views), prepared in accord- every research facility concerning each ance with the requirements of § 2.31(c)(3) of this subpart, and for- live dog or cat under paragraph (a) of warded to the Institutional Official. this section, every research facility (b) Every research facility shall transporting, selling, or otherwise dis- make, keep, and maintain records or posing of any live dog or cat to another forms which fully and correctly dis- person, shall make and maintain close the following information con- records or forms which fully and cor- cerning each live dog or cat purchased rectly disclose the following informa- or otherwise acquired, owned, held, or tion: otherwise in their possession or under (1) The name and address of the per- their control, transported, euthanized, son to whom a live dog or cat is trans- sold, or otherwise disposed of by the reported, sold, or otherwise disposed of; search facility. The records shall in- (2) The date of transportation, sale, clude any offspring born of any animal euthanasia, or other disposition of the while in the research facility’s posses- animal; and sion or under its control: (3) The method of transportation, in- (1) The name and address of the per- cluding the name of the initial carrier son from whom a dog or cat was pur- or intermediate handler, or if a pri- chased or otherwise acquired, whether vately owned vehicle is used to trans- or not the person is required to be li- port the dog or cat, the name of the censed or registered under the Act; owner of the privately owned vehicle.

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(d)(1) The USDA Interstate and Inter- confidential will be governed by appli- national Certificate of Health Exam- cable sections of the Freedom of Infor- ination for Small Animals (APHIS mation Act. Whenever the Adminis- Form 7001) and Record of Aquisition trator notifies a research facility in and Dogs and Cats on Hand (APHIS writing that specified records shall be Form 7005) are forms which may be retained pending completion of an in- used by research facilities to keep and vestigation or proceeding under the maintain the information required by Act, the research facility shall hold paragraph (b) of this section. those records until their disposition is (2) The USDA Interstate and Inter- authorized in writing by the Adminis- national Certificate of Health Exam- trator. ination for Small Animals (APHIS (Approved by the Office of Management and Form 7001) and Record of Disposition of Budget under control number 0579–0254) Dogs and Cats (APHIS Form 7006) are [54 FR 36147, Aug. 31, 1989, as amended at 58 forms which may be used by research FR 39129, July 22, 1993; 60 FR 13895, Mar. 15, facilities to keep and maintain the in- 1995; 69 FR 42101, July 14, 2004] formation required by paragraph (c) of this section. § 2.36 Annual report. (e) One copy of the record containing (a) The reporting facility shall be the information required by paragraphs that segment of the research facility, (b) and (c) of this section shall accom- or that department, agency, or instru- pany each shipment of any live dog or mentality of the United States, that cat sold or otherwise disposed of by a uses or intends to use live animals in research facility; Provided, however, research, tests, experiments, or for That, except as provided in § 2.133 of teaching. Each reporting facility shall this part, information that indicates submit an annual report to the AC Re- the source and date of acquisition of gional Director for the State where the any dog or cat need not appear on the facility is located on or before Decem- copy of the record accompanying the ber 1 of each calendar year. The report shipment. One copy of the record con- shall be signed and certified by the taining the information required by CEO or Institutional Official, and shall paragraphs (b) and (c) of this section cover the previous Federal fiscal year. shall be retained by the research facil- (b) The annual report shall: ity. (1) Assure that professionally accept- (f) All records and reports shall be able standards governing the care, maintained for at least three years. treatment, and use of animals, includ- Records that relate directly to pro- ing appropriate use of anesthetic, an- posed activities and proposed signifi- algesic, and tranquilizing drugs, prior cant changes in ongoing activities re- to, during, and following actual reviewed and approved by the IACUC search, teaching, testing, surgery, or shall be maintained for the duration of experimentation were followed by the the activity and for an additional three research facility; years after completion of the activity. (2) Assure that each principal investi- All records shall be available for in- gator has considered alternatives to spection and copying by authorized painful procedures; APHIS or funding Federal agency rep- (3) Assure that the facility is adher- resentatives at reasonable times. ing to the standards and regulations APHIS inspectors will maintain the under the Act, and that it has required confidentiality of the information and that exceptions to the standards and will not remove the materials from the regulations be specified and explained research facilities’ premises unless by the principal investigator and ap- there has been an alleged violation, proved by the IACUC. A summary of all they are needed to investigate a pos- such exceptions must be attached to sible violation, or for other enforce- the facility’s annual report. In addition ment purposes. Release of any such to identifying the IACUC-approved ex- materials, including reports, sum- ceptions, this summary must include a maries, and photographs that contain brief explanation of the exceptions, as trade secrets or commercial or finan- well as the species and number of ani- cial information that is privileged or mals affected;

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(4) State the location of all facilities sponsible for all corrective action to be where animals were housed or used in taken at the facility and for the grant- actual research, testing, teaching, or ing of all exceptions to inspection pro- experimentation, or held for these pur- tocol. poses; (5) State the common names and the § 2.38 Miscellaneous. numbers of animals upon which teach- (a) Information as to business: fur- ing, research, experiments, or tests nishing of same by research facilities. were conducted involving no pain, dis- Each research facility shall furnish to tress, or use of pain-relieving drugs. any APHIS official any information Routine procedures (e.g., injections, concerning the business of the research tattooing, blood sampling) should be facility which the APHIS official may reported with this group; request in connection with the enforce- (6) State the common names and the ment of the provisions of the Act, the numbers of animals upon which experi- regulations, and the standards in this ments, teaching, research, surgery, or subchapter. The information shall be tests were conducted involving accom- furnished within a reasonable time and panying pain or distress to the animals as may be specified in the request for and for which appropriate anesthetic, information. analgesic, or tranquilizing drugs were (b) Access and inspection of records and used; property. (1) Each research facility (7) State the common names and the shall, during business hours, allow numbers of animals upon which teach- APHIS officials: ing, experiments, research, surgery, or (i) To enter its place of business; tests were conducted involving accom- (ii) To examine records required to be panying pain or distress to the animals kept by the Act and the regulations in and for which the use of appropriate this part; anesthetic, analgesic, or tranquilizing (iii) To make copies of the records; drugs would have adversely affected (iv) To inspect the facilities, prop- the procedures, results, or interpreta- erty, and animals, as the APHIS offi- tion of the teaching, research, experi- cials consider necessary to enforce the ments, surgery, or tests. An expla- provisions of the Act, the regulations, nation of the procedures producing and the standards in this subchapter; pain or distress in these animals and and the reasons such drugs were not used (v) To document, by the taking of shall be attached to the annual report; photographs and other means, condi- (8) State the common names and the tions and areas of noncompliance. numbers of animals being bred, condi- (2) The use of a room, table or other tioned, or held for use in teaching, facilities necessary for the proper ex- testing, experiments, research, or sur- amination of the records and for in- gery but not yet used for such pur- spection of the property or animals poses. shall be extended to APHIS officials by [54 FR 36147, Aug. 31, 1989, as amended at 63 the research facility. FR 62926, Nov. 10, 1998] (c) Publication of names of research facilities subject to the provisions of this § 2.37 Federal research facilities. part. APHIS will publish lists of re- Each Federal research facility shall search facilities registered in accord- establish an Institutional Animal Care ance with the provisions of this sub- and Use Committee which shall have part in the FEDERAL REGISTER. The the same composition, duties, and re- lists may be obtained upon request sponsibilities required of nonfederal re- from the AC Regional Director. search facilities by § 2.31 with the fol- (d) Inspection for missing animals. lowing exceptions: Each research facility shall allow, upon (a) The Committee shall report defi- request and during business hours, po- ciencies to the head of the Federal lice or officers of other law enforce- agency conducting the research rather ment agencies with general law en- than to APHIS; and forcement authority (not those agen- (b) The head of the Federal agency cies whose duties are limited to en- conducting the research shall be re- forcement of local animal regulations)

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to enter its place of business to inspect be euthanized. The research facility animals and records for the purpose of from which the animals were con- seeking animals that are missing, fiscated shall bear all costs incurred in under the following conditions: performing the placement or eutha- (1) The police or other law officer nasia activities authorized by this sec- shall furnish to the research facility a tion. written description of the missing ani- (f) Handling. (1) Handling of all animal and the name and address of its mals shall be done as expeditiously and owner before making a search; carefully as possible in a manner that (2) The police or other law officer does not cause trauma, overheating, shall abide by all security measures re- excessive cooling, behavioral stress, quired by the research facility to pre- physical harm, or unnecessary discom- vent the spread of disease, including fort. the use of sterile clothing, footwear, (2)(i) Physical abuse shall not be used and masks where required, or to pre- to train, work, or otherwise handle ani- vent the escape of an animal. mals. (e) Confiscation and destruction of ani- (ii) Deprivation of food or water shall mals. (1) If an animal being held by a not be used to train, work, or otherwise research facility is not being used to handle animals; Provided, however: carry out research, testing, or experi- That the short-term withholding of mentation, and is found by an APHIS food or water from animals, when spec- official to be suffering as a result of the ified in an IACUC-approved activity failure of the research facility to com- that includes a description of moni- ply with any provision of the regula- toring procedures, is allowed by these tions or the standards set forth in this regulations. subchapter, the APHIS official shall (g) Identification of dogs and cats. (1) make a reasonable effort to notify the All live dogs or cats, including those research facility of the condition of the from any exempt source, delivered for animal(s) and request that the condi- transportation, transported, purchased tion be corrected and that adequate or otherwise acquired. sold, or disposed care be given to alleviate the animal’s of by a research facility, shall be iden- suffering or distress, or that the ani- tified at the time of such delivery for mal(s) be destroyed by euthanasia. In transportation, purchase, sale, dis- the event that the research facility re- posal, or acquisition in one of the fol- fuses to comply with this request, the lowing ways: APHIS official may confiscate the ani- (i) By the official tag or tattoo which mal(s) for care, treatment, or disposal was affixed to the animal at the time it as indicated in paragraph (e)(2) of this was acquired by the research facility, section, if, in the opinion of the Admin- as required by this section; or istrator, the circumstances indicate (ii) By a tag, tattoo, or collar, ap- the animal’s health is in danger. plied to the live dog or cat by the re- (2) In the event that the APHIS offi- search facility and which individually cial is unable to locate or notify the re- identifies the dog or cat by number. search facility as required in this sec- (2) All official tag or tattoo numbers tion, the APHIS official shall contact a shall be correctly listed in the records local police or other law officer to ac- of purchase, acquisition, disposal, or company him or her to the premises sale which shall be maintained in ac- and shall provide for adequate care cordance with § 2.35. when necessary to alleviate the ani- (3) Unweaned puppies or kittens need mal’s suffering. If, in the opinion of the not be individually identified while Administrator, the condition of the they are maintained as a litter with animal(s) cannot be corrected by this their dam in the same primary enclo- temporary care, the APHIS official sure, provided the dam has been indi- shall confiscate the animal(s). vidually identified. (3) Confiscated animals may be (4) The official tag shall be made of a placed, by sale or donation, with other durable alloy such as brass, bronze, or registrants or licensees that comply steel, or of a durable plastic. Alu- with the standards and regulations and minum of a sufficient thickness to as- can provide proper care, or they may sure the tag is durable and legible may

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also be used. The tag may be circular cial tag is euthanized, or dies from in shape and not less than 11⁄4 inches in other causes, the research facility shall diameter, or oblong and flat in shape remove and retain the tag for the re- and not less than 2 inches by 3⁄4 inch, quired period, as set forth in paragraph and riveted to an acceptable collar. (g)(11) of this section. (5) Each tag shall have the following (11) All official tags removed and re- information embossed or stamped on so tained by a research facility shall be that it is easily readable: held until called for by an APHIS offi- (i) The letters ‘‘USDA’’; cial or for a period of 1 year. (ii) Numbers identifying the State (12) When official tags are removed and dealer, exhibitor, or research facil- from animals for disposal, the tags ity (e.g., 39–AB); and must be disposed of so as to preclude (iii) Numbers identifying the animal their reuse for animal identification. (e.g., 82488). No animal identification number shall (6) Official tags shall be serially num- be used within any 5-year period fol- bered and shall be applied to dogs or lowing its previous use. cats in the manner set forth in this section in as close to consecutive nu- (h) Health certification. (1) No research merical order as possible. No tag num- facility, including a Federal research ber shall be used to identify more than facility, shall deliver to any inter- one animal or shall be reused within a mediate handler or carrier for trans- 5-year period. portation, in commerce, or shall trans- (7) Research facilities may obtain, at port in commerce any dog, cat, or their own expense, official tags from nonhuman primate unless the dog, cat, commercial tag manufacturers. 1 At the or nonhuman primate is accompanied time the research facility is registered, by a health certificate executed and the Department will assign identifica- issued by a licensed veterinarian. The tion letters and numbers to be used on health certificate shall state that: the official tags. (i) The licensed veterinarian in- (8) Each research facility shall be spected the dog, cat, or nonhuman pri- held accountable for all official tags mate on a specified date which shall acquired. In the event an official tag is not be more than 10 days prior to the lost from a dog or cat while in the pos- delivery of the dog, cat, or nonhuman session of a research facility, the facil- primate for transportation; and ity shall make a diligent effort to lo- (ii) When so inspected, the dog, cat, cate and reapply the tag to the proper or nonhuman primate appeared to the animal. If the lost tag is not located, licensed veterinarian to be free of any the research facility shall affix another infectious disease or physical abnor- official tag to the animal in the man- mality which would endanger the ani- ner prescribed in this section and mal(s) or other animals or endanger record the tag number on the official public health. records. (2) The Secretary may provide excep- (9) When a dog or cat wearing or tions to the health certification re- identified by an official tag arrives at a quirement on an individual basis for research facility, the facility may con- animals shipped to a research facility tinue to use that tag to identify the for purposes of research, testing, or ex- dog or cat or the tag may be replaced perimentation when the research facil- as indicated in paragraph (g)(1) of this ity requires animals not eligible for section. All tags removed by a research certification. Requests should be ad- facility shall be retained and disposed dressed to the Animal and Plant of as indicated in this section. Health Inspection Service, Animal (10) Where a dog or cat to which is af- Care, 4700 River Road, Unit 84, River- fixed or which is identified by an offi- dale, Maryland 20737–1234. (3) The U.S. Interstate and Inter- 1 A list of the commercial manufacturers national Certificate of Health Exam- who produce these tags and are known to the Department may be obtained from the AC ination for Small Animals (APHIS Regional Director. Any manufacturer who Form 7001) may be used for health cer- desires to be included in the list should notification by a licensed veterinarian as tify the Administrator. required by this section.

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(i) Holding of animals. If any research (4) Each research facility shall com- facility obtains prior approval of the ply with the regulations set forth in AC Regional Director, it may arrange § 2.133 of subpart I of this part. to have another person hold animals: [54 FR 36147, Aug. 31, 1989, as amended at 58 Provided, That: FR 39129, July 22, 1993; 59 FR 67612, Dec. 30, (1) The other person agrees, in writ- 1994; 60 FR 13895, Mar. 15, 1995; 63 FR 62926, ing, to comply with the regulations in Nov. 10, 1998; 69 FR 42101, July 14, 2004] this part and the standards in part 3 of EFFECTIVE DATE NOTE: At 77 FR 76823, Dec. this subchapter, and to allow inspec- 31, 2012, § 2.38 was amended by adding new tion of the premises by an APHIS offi- paragraphs (i)(4) and (l), effective Jan 30, 2013. For the convenience of the user, the cial during business hours; added text is set forth as follows: (2) The animals remain under the total control and responsibility of the § 2.38 Miscellaneous. research facility; and (3) The Institutional Official agrees, * * * * * in writing, that the other person or (i) * * * premises is a recognized animal site (4) The other person or premises must ei- under its research facility registration. ther be directly included in the research fa- APHIS Form 7009 shall be used for ap- cility’s contingency plan required under paragraph (l) of this section or must develop proval. its own contingency plan in accordance with (j) Holding period. Research facilities paragraph (l) of this section. that obtain dogs and cats from sources other than dealers, exhibitors, and ex- * * * * * empt persons shall hold the animals for (l) Contingency planning. (1) Research fa- 5 full days, not including the day of ac- cilities must develop, document, and follow quisition, after acquiring the animal, an appropriate plan to provide for the hu- excluding time in transit, before they mane handling, treatment, transportation, may be used by the facility. Research housing, and care of their animals in the facilities shall comply with the identi- event of an emergency or disaster (one which could reasonably be anticipated and expected fication of animals requirements set to be detrimental to the good health and forth in § 2.38(g) during this period. well-being of the animals in their posses- (k) Compliance with standards and pro- sion). Such contingency plans must: hibitions. (1) Each research facility (i) Identify situations the facility might shall comply in all respects with the experience that would trigger the need for the measures identified in a contingency regulations set forth in subpart C of plan to be put into action including, but not this part and the standards set forth in limited to, emergencies such as electrical part 3 of this subchapter for the hu- outages, faulty HVAC systems, fires, and mane handling, care, treatment, hous- animal escapes, as well as natural disasters ing, and transportation of animals; the facility is most likely to experience. (ii) Outline specific tasks required to be Provided, however, That exceptions to carried out in response to the identified the standards in part 3 and the provi- emergencies or disasters including, but not sions of subpart C of this part may be limited to, detailed animal evacuation in- made only when such exceptions are structions or shelter-in-place instructions specified and justified in the proposal and provisions for providing backup sources to conduct the activity and are ap- of food and water as well as sanitation, ventilation, bedding, veterinary care, etc.; proved by the IACUC. (iii) Identify a chain of command and who (2) No person shall obtain live dogs or (by name or by position title) will be respon- cats by use of false pretenses, misrepre- sible for fulfilling these tasks; and sentation, or deception. (iv) Address how response and recovery will be handled in terms of materials, re- (3) No person shall acquire, buy, sell, sources, and training needed. exhibit, use for research, transport, or (2) For current registrants, the contin- offer for transportation, any stolen gency plan must be in place by July 29, 2013. animal. For research facilities registered after this date, the contingency plan must be in place prior to conducting regulated activities. The plan must be reviewed by the research facility on at least an annual basis to ensure that

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it adequately addresses the criteria listed in care and to oversee the adequacy of paragraph (l)(1) of this section. Each reg- other aspects of animal care and use. istrant must maintain documentation of (b) Each dealer or exhibitor shall es- their annual reviews, including documenting any amendments or changes made to their tablish and maintain programs of ade- plan since the previous year’s review, such as quate veterinary care that include: changes made as a result of recently pre- (1) The availability of appropriate fa- dicted, but historically unforeseen, cir- cilities, personnel, equipment, and cumstances (e.g., weather extremes). Contin- services to comply with the provisions gency plans, as well as all annual review doc- of this subchapter; umentation and training records, must be made available to APHIS and any funding (2) The use of appropriate methods to Federal agency representatives upon request. prevent, control, diagnose, and treat Facilities maintaining or otherwise handling diseases and injuries, and the avail- marine mammals in captivity must also ability of emergency, weekend, and comply with the requirements of § 3.101(b) of holiday care; this subchapter. (3) Daily observation of all animals (3) The facility must provide and document to assess their health and well-being; participation in and successful completion of Provided, however, That daily observa- training for its personnel regarding their roles and responsibilities as outlined in the tion of animals may be accomplished plan. For current registrants, training of fa- by someone other than the attending cility personnel must be completed by Sep- veterinarian; and Provided, further, tember 27, 2013; for research facilities reg- That a mechanism of direct and fre- istered after July 29, 2013, training of facility quent communication is required so personnel must be completed within 60 days that timely and accurate information of the facility putting its contingency plan on problems of animal health, behav- in place. Employees hired 30 days or more before the contingency plan is put in place ior, and well-being is conveyed to the must also be trained by that date. For em- attending veterinarian; ployees hired less than 30 days before that (4) Adequate guidance to personnel date or after that date, training must be con- involved in the care and use of animals ducted within 30 days of their start date. regarding handling, immobilization, Any changes to the plan as a result of the anesthesia, analgesia, tranquilization, annual review must be communicated to em- and euthanasia; and ployees through training which must be conducted within 30 days of making the changes. (5) Adequate pre-procedural and post- procedural care in accordance with established veterinary medical and nurs- Subpart D—Attending Veterinarian ing procedures. and Adequate Veterinary Care

§ 2.40 Attending veterinarian and ade- Subpart E—Identification of quate veterinary care (dealers and Animals exhibitors). (a) Each dealer or exhibitor shall § 2.50 Time and method of identifica- have an attending veterinarian who tion. shall provide adequate veterinary care (a) A class ‘‘A’’ dealer (breeder) shall to its animals in compliance with this identify all live dogs and cats on the section. premises as follows: (1) Each dealer and exhibitor shall (1) All live dogs and cats held on the employ an attending veterinarian premises, purchased, or otherwise ac- under formal arrangements. In the case quired, sold or otherwise disposed of, or of a part-time attending veterinarian removed from the premises for delivery or consultant arrangements, the for- to a research facility or exhibitor or to mal arrangements shall include a writ- another dealer, or for sale, through an ten program of veterinary care and reg- auction sale or to any person for use as ularly scheduled visits to the premises a pet, shall be identified by an official of the dealer or exhibitor; and tag of the type described in § 2.51 af- (2) Each dealer and exhibitor shall as- fixed to the animal’s neck by means of sure that the attending veterinarian a collar made of material generally has appropriate authority to ensure considered acceptable to pet owners as the provision of adequate veterinary a means of identifying their pet dogs or

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cats 2, or shall be identified by a dis- maintained in accordance with §§ 2.75 tinctive and legible tattoo marking ac- and 2.77. Any new official tag or tattoo ceptable to and approved by the Ad- number shall be used on all records of ministrator. any subsequent sales by the dealer or (2) Live puppies or kittens, less than exhibitor, of any dog or cat. 16 weeks of age, shall be identified by: (3) Live puppies or kittens less than (i) An official tag as described in 16 weeks of age, shall be identified by: § 2.51; (i) An official tag as described in (ii) A distinctive and legible tattoo § 2.51; marking approved by the Adminis- (ii) A distinctive and legible tattoo trator; or marking approved by the Adminis- (iii) A plastic-type collar acceptable trator; or to the Administrator which has legibly (iii) A plastic-type collar acceptable placed thereon the information re- to the Administrator which has legibly quired for an official tag pursuant to placed thereon the information re- § 2.51. quired for an official tag pursuant to (b) A class ‘‘B’’ dealer shall identify § 2.51. all live dogs and cats under his or her (4) When any dealer has made a rea- control or on his or her premises as fol- sonable effort to affix an official tag to lows: a cat, as set forth in paragraphs (a) and (1) When live dogs or cats are held, (b) of this section, and has been unable purchased, or otherwise acquired, they to do so, or when the cat exhibits seri- shall be immediately identified: ous distress from the attachment of a (i) By affixing to the animal’s neck collar and tag, the dealer shall attach an official tag as set forth in § 2.51 by the collar and tag to the door of the means of a collar made of material primary enclosure containing the cat generally acceptable to pet owners as a and take measures adequate to main- means of identifying their pet dogs or tain the identity of the cat in relation 3 cats ; or to the tag. Each primary enclosure (ii) By a distinctive and legible tat- shall contain no more than one weaned too marking approved by the Adminis- cat without an affixed collar and offi- trator. cial tag, unless the cats are identified (2) If any live dog or cat is already by a distinctive and legible tattoo or identified by an official tag or tattoo plastic-type collar approved by the Ad- which has been applied by another ministrator. dealer or exhibitor, the dealer or ex- (c) A class ‘‘C’’ exhibitor shall iden- hibitor who purchases or otherwise ac- tify all live dogs and cats under his or quires the animal may continue identi- her control or on his or her premises, fying the dog or cat by the previous whether held, purchased, or otherwise identification number, or may replace acquired: the previous tag with his own official (1) As set forth in paragraph (b)(1) or tag or approved tattoo. In either case, the class B dealer or class C exhibitor (b)(3) of this section, or shall correctly list all old and new offi- (2) By identifying each dog or cat cial tag numbers or tattoos in his or with: her records of purchase which shall be (i) An official USDA sequentially numbered tag that is kept on the door of the animal’s cage or run; 2 In general, well fitted collars made of (ii) A record book containing each leather or plastic will be acceptable under this provision. The use of certain types of animal’s tag number, a written descrip- chains presently used by some dealers may tion of each animal, the data required also be deemed acceptable. APHIS will deter- by § 2.75(a), and a clear photograph of mine the acceptability of a material pro- each animal; and posed for usage as collars from the stand- (iii) A duplicate tag that accom- point of humane considerations on an indi- panies each dog or cat whenever it vidual basis in consultation with the dealer leaves the compound or premises. or exhibitor involved. The use of materials such as wire, elastic, or sharp metal that (d) Unweaned puppies or kittens need might cause discomfort or injury to the dogs not be individually identified as re- or cats is not acceptable. quired by paragraphs (a) and (b) of this 3 See footnote 2 in § 2.50(a)(1). section while they are maintained as a

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litter with their dam in the same pri- also be used. The tag shall be one of mary enclosure, provided the dam has the following shapes: been individually identified. (1) Circular in shape and not less (e)(1) All animals, except dogs and than 11⁄4 inches in diameter, or cats, delivered for transportation, (2) Oblong and flat in shape, not less transported, purchased, sold, or other- than 2 inches by 3⁄4 inch and riveted to wise acquired or disposed of by any an acceptable collar. dealer or exhibitor shall be identified (b) Each tag shall have the following by the dealer or exhibitor at the time information embossed or stamped on so of delivery for transportation, pur- that it is easily readable: chase, sale, acquisition or disposal, as (1) The letters ‘‘USDA’’; provided for in this paragraph and in (2) Numbers identifying the State records maintained as required in and dealer, exhibitor, or research facil- §§ 2.75 and 2.77. ity (e.g., 39–AB); and (2) When one or more animals, other (3) Numbers identifying the animal than dogs or cats, are confined in a pri- (e.g., 82488). mary enclosure, the animal(s) shall be (c) Official tags shall be serially identified by: numbered. No individual dealer or ex- (i) A label attached to the primary hibitor shall use any identification tag enclosure which shall bear a descrip- number more than once within a 5-year tion of the animals in the primary en- period. closure, including: § 2.52 How to obtain tags. (A) The number of animals; (B) The species of the animals; Dealers or exhibitors may obtain, at their own expense, official tags from (C) Any distinctive physical features commercial tag manufacturers. 4 At the of the animals; and time the dealer or exhibitor is issued a (D) Any identifying marks, tattoos, license or is registered, the Depart- or tags attached to the animals; ment will assign identification letters (ii) Marking the primary enclosure and numbers and inform them of the with a painted or stenciled number identification letters and numbers to which shall be recorded in the records be used on the official tags. of the dealer or exhibitor together with: [54 FR 36147, Aug. 31, 1989, as amended at 63 (A) A description of the animal(s); FR 62927, Nov. 10, 1998] (B) The species of the animal(s); and § 2.53 Use of tags. (C) Any distinctive physical features of the animal(s); or Official tags obtained by a dealer, ex- (iii) A tag or tattoo applied to each hibitor, or research facility, shall be animal in the primary enclosure by the applied to dogs or cats in the manner dealer or exhibitor which individually set forth in § 2.50 and in as close to con- identifies each animal by description secutive numerical order as possible. or number. No tag number shall be used to identify more than one animal. No number (3) When any animal, other than a shall be repeated within a 5-year pe- dog or cat, is not confined in a primary riod. enclosure, it shall be identified on a record, as required by § 2.75, which shall § 2.54 Lost tags. accompany the animal at the time it is delivered for transportation, trans- Each dealer or exhibitor shall be held ported, purchased, or sold, and shall be accountable for all official tags ac- kept and maintained by the dealer or quired. In the event an official tag is exhibitor as part of his or her records. lost from a dog or cat while in the possession of a dealer or exhibitor, the § 2.51 Form of official tag. 4 (a) The official tag shall be made of a A list of the commercial manufacturers who produce these tags and are known to the durable alloy such as brass, bronze, or Department may be obtained from the AC steel, or of a durable plastic. Alu- Regional Director. Any manufacturer who minum of a sufficient thickness to as- desires to be included in the list should no- sure the tag is durable and legible may tify the Administrator.

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dealer or exhibitor shall make a dili- chased or otherwise acquired whether gent effort to locate and reapply the or not the person is required to be li- tag to the proper animal. If the lost tag censed or registered under the Act; is not located, the dealer or exhibitor (ii) The USDA license or registration shall affix another official tag to the number of the person if he or she is li- animal in the manner prescribed in censed or registered under the Act; § 2.50, and record the tag number on the (iii) The vehicle license number and official records. State, and the driver’s license number § 2.55 Removal and disposal of tags. (or photographic identification card for nondrivers issued by a State) and State (a) Where a dog or cat to which is af- of the person, if he or she is not li- fixed or which is identified by an offi- censed or registered under the Act; cial tag is euthanized, or dies from (iv) The name and address of the per- other causes, the dealer or exhibitor son to whom a dog or cat was sold or shall remove and retain the tag for the required period, as set forth in para- given and that person’s license or reg- graph (b) of this section. istration number if he or she is li- (b) All official tags removed and re- censed or registered under the Act; tained by a dealer or exhibitor shall be (v) The date a dog or cat was ac- held until called for by an APHIS offi- quired or disposed of, including by eu- cial or for a period of 1 year. thanasia; (c) When official tags are removed (vi) The official USDA tag number or from animals for disposal, the tags tattoo assigned to a dog or cat under must be disposed of so as to preclude §§ 2.50 and 2.54; their reuse for animal identification. (vii) A description of each dog or cat No animal identification number shall which shall include: be used within any 5-year period fol- (A) The species and breed or type; lowing its previous use. (B) The sex; (C) The date of birth or approximate Subpart F—Stolen Animals age; and (D) The color and any distinctive § 2.60 Prohibition on the purchase, sale, use, or transportation of stolen markings; animals. (viii) The method of transportation No person shall buy, sell, exhibit, use including the name of the initial car- for research, transport, or offer for rier or intermediate handler or, if a transportation, any stolen animal. privately owned vehicle is used to transport a dog or cat, the name of the Subpart G—Records owner of the privately owned vehicle; (ix) The date and method of disposi- § 2.75 Records: Dealers and exhibitors. tion of a dog or cat, e.g., sale, death, (a)(1) Each dealer, other than opera- euthanasia, or donation. tors of auction sales and brokers to (2) Each dealer and exhibitor shall whom animals are consigned, and each use Record of Aquisition and Dogs and exhibitor shall make, keep, and main- Cats on Hand (APHIS Form 7005) and tain records or forms which fully and Record of Disposition of Dogs and Cats correctly disclose the following infor- (APHIS Form 7006) to make, keep, and mation concerning each dog or cat pur- maintain the information required by chased or otherwise acquired, owned, paragraph (a)(1) of this section: Pro- held, or otherwise in his or her posses- vided, that if a dealer or exhibitor who sion or under his or her control, or uses a computerized recordkeeping sys- which is transported, euthanized, sold, tem believes that APHIS Form 7005 and or otherwise disposed of by that dealer APHIS Form 7006 are unsuitable for or exhibitor. The records shall include him or her to make, keep, and main- any offspring born of any animal while tain the information required by para- in his or her possession or under his or graph (a)(1) of this section, the dealer her control. or exhibitor may request a variance (i) The name and address of the per- from the requirement to use APHIS son from whom a dog or cat was pur- Form 7005 and APHIS Form 7006.

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(i) The request for a variance must tion concerning animals other than consist of a written statement describ- dogs and cats, purchased or otherwise ing why APHIS Form 7005 and APHIS acquired, owned, held, leased, or other- Form 7006 are unsuitable for the dealer wise in his or her possession or under or exhibitor to make, keep, and main- his or her control, or which is trans- tain the information required by para- ported, sold, euthanized, or otherwise graph (a)(1) of this section, and a de- disposed of by that dealer or exhibitor. scription of the computerized record- The records shall include any offspring keeping system the person would use in born of any animal while in his or her lieu of APHIS Form 7005 and APHIS possession or under his or her control. Form 7006 to make, keep, and maintain (i) The name and address of the per- the information required by paragraph son from whom the animals were pur- (a)(1) of this section. APHIS will advise chased or otherwise acquired; the person as to the disposition of his (ii) The USDA license or registration or her request for a variance from the number of the person if he or she is li- requirement to use APHIS Form 7005 censed or registered under the Act; and APHIS Form 7006. (iii) The vehicle license number and (ii) A dealer or exhibitor whose re- State, and the driver’s license number quest for a variance has been denied (or photographic identification card for may request a hearing in accordance nondrivers issued by a State) and State with the applicable rules of practice for of the person, if he or she is not li- the purpose of showing why the request censed or registered under the Act; for a variance should not be denied. (iv) The name and address of the per- The denial of the variance shall remain son to whom an animal was sold or in effect until the final legal decision given; has been rendered. (v) The date of purchase, acquisition, (3) The USDA Interstate and Inter- sale, or disposal of the animal(s); national Certificate of Health Exam- (vi) The species of the animal(s); and ination for Small Animals (APHIS (vii) The number of animals in the Form 7001) may be used by dealers and shipment. exhibitors to make, keep, and maintain (2) Record of Animals on Hand (other the information required by § 2.79. than dogs and cats) (APHIS Form 7019) (4) One copy of the record containing and Record of Acquisition, Disposition, the information required by paragraph or Transport of Animals (other than (a)(1) of this section shall accompany dogs and cats) (APHIS Form 7020) are each shipment of any dog or cat pur- forms which may be used by dealers chased or otherwise acquired by a deal- and exhibitors to keep and maintain er or exhibitor. One copy of the record the information required by paragraph containing the information required by (b)(1) of this section concerning ani- paragraph (a)(1) of this section shall mals other than dogs and cats except accompany each shipment of any dog as provided in § 2.79. or cat sold or otherwise disposed of by (3) One copy of the record containing a dealer or exhibitor: Provided, however, the information required by paragraph that, except as provided in § 2.133(b) of (b)(1) of this section shall accompany this part for dealers, information that each shipment of any animal(s) other indicates the source and date of acqui- than a dog or cat purchased or other- sition of a dog or cat need not appear wise acquired by a dealer or exhibitor. on the copy of the record accom- One copy of the record containing the panying the shipment. One copy of the information required by paragraph record containing the information re- (b)(1) of this section shall accompany quired by paragraph (a)(1) of this sec- each shipment of any animal other tion shall be retained by the dealer or than a dog or cat sold or otherwise dis- exhibitor. posed of by a dealer or exhibitor; Pro- (b)(1) Every dealer other than opera- vided, however, That information which tors of auction sales and brokers to indicates the source and date of acqui- whom animals are consigned, and ex- sition of any animal other than a dog hibitor shall make, keep, and maintain or cat need not appear on the copy of records or forms which fully and cor- the record accompanying the shipment. rectly disclose the following informa- The dealer or exhibitor shall retain one

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copy of the record containing the infor- of any animal. One copy of the record mation required by paragraph (b)(1) of containing the information required by this section. paragraph (a) of this section shall be retained by the operator of such auc- [54 FR 36147, Aug. 31, 1989, as amended at 58 FR 39129, July 22, 1993; 58 FR 45041, Aug. 26, tion sale, or broker, for each animal 1993; 60 FR 13895, Mar. 15, 1995; 69 FR 42102, sold by the auction sale or broker. July 14, 2004] [54 FR 36147, Aug. 31, 1989, as amended at 69 FR 42102, July 14, 2004] § 2.76 Records: Operators of auction sales and brokers. § 2.77 Records: Carriers and inter- (a) Every operator of an auction sale mediate handlers. or broker shall make, keep, and main- (a) In connection with all live ani- tain records or forms which fully and mals accepted for shipment on a C.O.D. correctly disclose the following infor- basis or other arrangement or practice mation concerning each animal con- under which the cost of an animal or signed for auction or sold, whether or the transportation of an animal is to not a fee or commission is charged: be paid and collected upon delivery of (1) The name and address of the per- the animal to the consignee, the ac- son who owned or consigned the ani- cepting carrier or intermediate han- mal(s) for sale; dler, if any, shall keep and maintain a (2) The name and address of the copy of the consignor’s written guar- buyer or consignee who received the antee for the payment of transpor- animal; tation charged for any animal not (3) The USDA license or registration claimed as provided in § 2.80, including, number of the person(s) selling, con- where necessary, both the return trans- signing, buying, or receiving the ani- portation charges and an amount suffi- mals if he or she is licensed or reg- cient to reimburse the carrier for out- istered under the Act; of-pocket expenses incurred for the (4) The vehicle license number and care, feeding, and storage of the ani- State, and the driver’s license number mal. The carrier or intermediate han- (or photographic identification card for dler at destination shall also keep and nondrivers issued by a State) and State maintain a copy of the shipping docu- of the person, if he or she is not li- ment containing the time, date, and censed or registered under the Act; method of each attempted notification (5) The date of the consignment; and the final notification to the con- (6) The official USDA tag number or signee and the name of the person noti- tattoo assigned to the animal under fying the consignee, as provided in §§ 2.50 and 2.54; § 2.80. (7) A description of the animal which (b) In connection with all live dogs, shall include: cats, or nonhuman primates delivered (i) The species and breed or type of for transportation, in commerce, to animal; any carrier or intermediate handler, by (ii) The sex of the animal; and any dealer, research facility, exhibitor, (iii) The date of birth or approximate operator of an auction sale, broker, or age; and department, agency or instrumentality (iv) The color and any distinctive of the United States or of any state or markings; local government, the accepting car- (8) The auction sales number or rier or intermediate handler shall keep records number assigned to the animal. and maintain a copy of the health cer- (b) One copy of the record containing tification completed as required by the information required by paragraph § 2.79, tendered with each live dog, cat, (a) of this section shall be given to the or nonhuman primate. consignor of each animal, one copy of the record shall be given to the pur- § 2.78 Health certification and identi- chaser of each animal: Provided, how- fication. ever, That information which indicates (a) No dealer, exhibitor, operator of the source and date of consignment of an auction sale, broker, or department, any animal need not appear on the agency, or instrumentality of the copy of the record given the purchaser United States or of any State or local

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government shall deliver to any inter- tification by a licensed veterinarian as mediate handler or carrier for trans- required by this section. portation, in commerce, or shall trans- [54 FR 36147, August 31, 1989, as amended at port in commerce any dog, cat, or 59 FR 67612, Dec. 30, 1994; 60 FR 13896, Mar. 15, nonhuman primate unless the dog, cat, 1995; 63 FR 62927, Nov. 10, 1998; 69 FR 42102, or nonhuman primate is accompanied July 14, 2004] by a health certificate executed and § 2.79 C.O.D. shipments. issued by a licensed veterinarian. The health certificate shall state that: (a) No carrier or intermediate han- (1) The licensed veterinarian in- dler shall accept any animal for trans- spected the dog, cat, or nonhuman pri- portation, in commerce, upon any C.O.D. or other basis where any money mate on a specified date which shall is to be paid and collected upon deliv- not be more than 10 days prior to the ery of the animal to the consignee, un- delivery of the dog, cat, or nonhuman less the consignor guarantees in writ- primate for transportation; and ing the payment of all transportation, (2) when so inspected, the dog, cat, or including any return transportation, if nonhuman primate appeared to the li- the shipment is unclaimed or the con- censed veterinarian to be free of any signee cannot be notified in accordance infectious disease or physical abnor- with paragraphs (b) and (c) of this sec- mality which would endanger the ani- tion, including reimbursing the carrier mal(s) or other animals or endanger or intermediate handler for all out-of- public health. pocket expenses incurred for the care, (b) The Secretary may provide excep- feeding, and storage or housing of the tions to the health certification re- animal. quirement on an individual basis for (b) Any carrier or intermediate han- animals shipped to a research facility dler receiving an animal at a destina- for purposes of research, testing, or ex- tion on a C.O.D. or other basis any perimentation when the research facil- money is to be paid and collected upon ity requires animals not eligible for delivery of the animal to the consignee certification. Requests should be ad- shall attempt to notify the consignee at least once every 6 hours for a period dressed to the Animal and Plant of 24 hours after arrival of the animal Health Inspection Service, Animal at the animal holding area of the ter- Care, 4700 River Road, Unit 84, River- minal cargo facility. The carrier or in- dale, Maryland 20737–1234. termediate handler shall record the (c) No intermediate handler or car- time, date, and method of each at- rier to whom any live dog, cat, or tempted notification and the final no- nonhuman primate is delivered for tification to the consignee, and the transportation by any dealer, research name of the person notifying the con- facility, exhibitor, broker, operator of signee, on the shipping document and an auction sale, or department, agency, on the copy of the shipping document or instrumentality of the United accompanying the C.O.D. shipment. If States or any State or local govern- the consignee cannot be notified of the ment shall receive a live dog, cat, or C.O.D. shipment within 24 hours after nonhuman primate for transportation, its arrival, the carrier or intermediate in commerce, unless and until it is ac- handler shall return the animal to the companied by a health certificate consignor, or to whomever the con- issued by a licensed veterinarian in ac- signor has designated, on the next cordance with paragraph (a) of this sec- practical available transportation, in tion, or an exemption issued by the accordance with the written agreement Secretary in accordance with para- required in paragraph (a) of this sec- graph (b) of this section. tion and shall notify the consignor. Any carrier or intermediate handler (d) The U.S. Interstate and Inter- which has notified a consignee of the national Certificate of Health Exam- arrival of a C.O.D. or other shipment of ination for Small Animals (APHIS an animal, where any money is to be Form 7001) may be used for health cer- paid and collected upon delivery of the animal to the consignee, which is not

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claimed by the consignee within 48 their disposition is authorized by the hours from the time of notification, Administrator. shall return the animal to the consignor, or to whomever the consignor Subpart H—Compliance With has designated, on the next practical Standards and Holding Period available transportation, in accordance with the written agreement required in § 2.100 Compliance with standards. paragraph (a) of this section and shall notify the consignor. (a) Each dealer, exhibitor, operator of (c) It is the responsibility of any car- an auction sale, and intermediate han- rier or intermediate handler to hold, dler shall comply in all respects with feed, and care for any animal accepted the regulations set forth in part 2 and for transportation, in commerce, under the standards set forth in part 3 of this a C.O.D. or other arrangement where subchapter for the humane handling, any money is to be paid and collected care, treatment, housing, and transpor- upon delivery of the animal until the tation of animals. consignee accepts shipment at destina- (b) Each carrier shall comply in all tion or until returned to the consignor respects with the regulations in part 2 or his or her designee should the con- and the standards in part 3 of this sub- signee fail to accept delivery of the chapter setting forth the conditions animal or if the consignee could not be and requirements for the humane notified as prescribed in paragraph (b) transportation of animals in commerce of this section. and their handling, care, and treat- (d) Nothing in this section shall be ment in connection therewith. construed as prohibiting any carrier or intermediate handler from requiring § 2.101 Holding period. any guarantee in addition to that re- (a) Any live dog or cat acquired by a quired in paragraph (a) of this section dealer 5 or exhibitor shall be held by for the payment of the cost of any him or her, under his or her super- transportation or out-of-pocket or vision and control, for a period of not other incidental expenses incurred in less than 5 full days, not including the the transportation of any animal. day of acquisition, after acquiring the § 2.80 Records, disposition. animal, excluding time in transit: Pro- vided, however: (a) No dealer, exhibitor, broker, operator of an auction sale, carrier, or in- (1) That any live dog or cat acquired termediate handler shall, for a period by a dealer or exhibitor from any pri- of 1 year, destroy or dispose of, without vate or contract animal pound or shel- the consent in writing of the Adminis- ter shall be held by that dealer or ex- trator, any books, records, documents, hibitor under his or her supervision or other papers required to be kept and and control for a period of not less maintained under this part. than 10 full days, not including the day (b) Unless otherwise specified, the of acquisition, after acquiring the ani- records required to be kept and main- mal, excluding time in transit; tained under this part shall be held for (2) Live dogs or cats which have com- 1 year after an animal is euthanized or pleted a 5-day holding period with an- disposed of and for any period in excess other dealer or exhibitor, or a 10-day of one year as necessary to comply holding period with another dealer or with any applicable Federal, State, or exhibitor if obtained from a private or local law. Whenever the Administrator contract shelter or pound, may be sold notifies a dealer, exhibitor, broker, op- or otherwise disposed of by subsequent erator of an auction sale, carrier, or in- dealers or exhibitors after a minimum termediate handler in writing that holding period of 24 hours by each sub- specified records shall be retained sequent dealer or exhibitor excluding pending completion of an investigation time in transit; or proceeding under the Act, the dealer, exhibitor, broker, operator of an 5 An operator of an auction sale is not con- auction sale, carrier, or intermediate sidered to have acquired a dog or cat which handler shall hold those records until is sold through the auction sale.

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(3) Any dog or cat suffering from dis- the premises by an APHIS official dur- ease, emaciation, or injury may be de- ing business hours; and stroyed by euthanasia prior to the (2) The animals remain under the completion of the holding period re- total control and responsibility of the quired by this section; and research facility or intermediate han- (4) Any live dog or cat, 120 days of dler. age or less, that was obtained from the [54 FR 36147, Aug. 31, 1989, as amended at 60 person that bred and raised such dog or FR 13896, Mar. 15, 1995; 63 FR 62927, Nov. 10, cat, may be exempted from the 5-day 1998; 69 FR 42102, July 14, 2004] holding requirement and may be dis- EFFECTIVE DATE NOTE: At 77 FR 76823, Dec. posed of by dealers or exhibitors after a 31, 2012, § 2.102 was amended by adding new minimum holding period of 24 hours, paragraphs (a)(4) and (b)(3), effective Jan. 30, excluding time in transit. Each subse- 2013. For the convenience of the user, the quent dealer or exhibitor must also added text is set forth as follows: hold each such dog or cat for a 24-hour § 2.102 Holding facility. period excluding time in transit. (a) * * * (b) During the period in which any (4) The other person or premises must ei- dog or cat is being held as required by ther be directly included in the dealer’s or this section, the dog or cat shall be un- exhibitor’s contingency plan required under loaded from any means of conveyance § 2.134 or must develop its own contingency in which it was received, for food, plan in accordance with § 2.134. (b) * * * water, and rest, and shall be handled, (3) The other person or premises must ei- cared for, and treated in accordance ther be directly included in the intermediate with the standards set forth in part 3, handler’s contingency plan required under subpart A, of this subchapter and § 2.134 or must develop its own contingency § 2.131. plan in accordance with § 2.134. § 2.102 Holding facility. Subpart I—Miscellaneous (a) If any dealer or exhibitor obtains the prior approval of the AC Regional § 2.125 Information as to business; furnishing of same by dealers, exhibi- Director, he may arrange to have an- tors, operators of auction sales, in- other person hold animals for the re- termediate handlers, and carriers. quired period provided for in paragraph Each dealer, exhibitor, operator of an (a) of § 2.101: Provided, That: auction sale, intermediate handler, and (1) The other person agrees in writing carrier shall furnish to any APHIS offi- to comply with the regulations in part cial any information concerning the 2 and the standards in part 3 of this business of the dealer, exhibitor, oper- subchapter and to allow inspection of ator of an auction sale, intermediate his premises by an APHIS official dur- handler or carrier which the APHIS of- ing business hours; and ficial may request in connection with (2) The animals remain under the the enforcement of the provisions of total control and responsibility of the the Act, the regulations and the stand- dealer or exhibitor. ards in this subchapter. The informa- (3) Approval will not be given for a tion shall be furnished within a reason- dealer or exhibitor holding a license as able time and as may be specified in set forth in § 2.1 to have animals held the request for information. for purposes of this section by another licensed dealer or exhibitor. APHIS § 2.126 Access and inspection of Form 7009 shall be used for approval. records and property. (b) If any intermediate handler ob- (a) Each dealer, exhibitor, inter- tains prior approval of the AC Regional mediate handler, or carrier, shall, dur- Director, it may arrange to have an- ing business hours, allow APHIS offi- other person hold animals: Provided, cials: That: (1) To enter its place of business; (1) The other person agrees in writing (2) To examine records required to be to comply with the regulations in part kept by the Act and the regulations in 2 and the standards in part 3 of this this part; subchapter and to allow inspection of (3) To make copies of the records;

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(4) To inspect and photograph the fa- ness name and current Act license or reg- cilities, property and animals, as the istration number and, in the event that any APHIS officials consider necessary to animal is leased, borrowed, loaned, or under enforce the provisions of the Act, the some similar arrangement, the name of the person who owns such animal; regulations and the standards in this (ii) The name, identification number or subchapter; and identifying characteristics, species (common (5) To document, by the taking of or scientific name), sex and age of each ani- photographs and other means, condi- mal; and tions and areas of noncompliance. (iii) The names, dates, and locations (with (b) The use of a room, table, or other addresses) where the animals will travel, be facilities necessary for the proper ex- housed, and be exhibited, including all an- amination of the records and inspec- ticipated dates and locations (with address- tion of the property or animals must be es) for any stops and layovers that allow or extended to APHIS officials by the require removal of the animals from the transport enclosures. Unanticipated delays dealer, exhibitor, intermediate handler of such length shall be reported to the AC or carrier, and a responsible adult shall Regional Director the next APHIS business be made available to accompany day. APHIS Regional offices are available APHIS officials during the inspection each weekday, except on Federal holidays, process. from 8 a.m. to 5 p.m. (2) The itinerary shall be revised as nec- [54 FR 36147, Aug. 31, 1989, as amended at 69 essary, and the AC Regional Director shall FR 42102, July 14, 2004] be notified of any changes. If initial notifica- EFFECTIVE DATE NOTE: At 77 FR 76814, Dec. tion of a change due to an emergency is 31, 2012, § 2.126 was amended by revising the made by a means other than email or fac- section heading and adding a new paragraph simile, it shall be followed by written docu- (c) and OMB citation at the end of the sec- mentation at the earliest possible time. For tion, effective Jan. 30, 2013. For the conven- changes that occur after normal APHIS busi- ience of the user, the added and revised text ness hours, the change shall be conveyed to is set forth as follows: the AC Regional Director no later than the following APHIS business day. APHIS Re- § 2.126 Access and inspection of records and gional offices are available each weekday, property; submission of itineraries. except on Federal holidays, from 8 a.m. to 5 p.m. * * * * * (Approved by the Office of Management and (c) Any person who is subject to the Ani- Budget under control number 0579–0361) mal Welfare regulations and who intends to exhibit any animal at any location other § 2.127 Publication of names of per- than the person’s approved site (including, sons subject to the provisions of but not limited to, circuses, traveling edu- this part. cational exhibits, animal acts, and petting zoos), except for travel that does not extend APHIS will publish lists of persons li- overnight, shall submit a written itinerary censed or registered in accordance with to the AC Regional Director. The itinerary the provisions of this part in the FED- shall be received by the AC Regional Direc- ERAL REGISTER. The lists may be ob- tor no fewer than 2 days in advance of any tained upon request from the AC Re- travel and shall contain complete and accu- gional Director. rate information concerning the where- abouts of any animal intended for exhibition [54 FR 36147, Aug. 31, 1989, as amended at 63 at any location other than the person’s ap- FR 62927, Nov. 10, 1998] proved site. If the exhibitor accepts an en- gagement for which travel will begin with § 2.128 Inspection for missing animals. less than 48 hours’ notice, the exhibitor shall immediately contact the AC Regional Direc- Each dealer, exhibitor, intermediate tor in writing with the required information. handler and carrier shall allow, upon APHIS expects such situations to occur in- request and during business hours, po- frequently, and exhibitors who repeatedly lice or officers of other law enforce- provide less than 48 hours’ notice will, after ment agencies with general law en- notice by APHIS, be subject to increased forcement authority (not those agen- scrutiny under the Act. cies whose duties are limited to en- (1) The itinerary shall include the following: forcement of local animal regulations) (i) The name of the person who intends to to enter his or her place of business to exhibit the animal and transport the animal inspect animals and records for the for exhibition purposes, including any busi- purpose of seeking animals that are

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missing, under the following condi- (c) Confiscated animals may be: tions: (1) Placed, by sale or donation, with (a) The police or other law officer other licensees or registrants that shall furnish to the dealer, exhibitor, comply with the standards and regula- intermediate handler or carrier a writ- tions and can provide proper care; or ten description of the missing animal (2) Placed with persons or facilities and the name and address of its owner that can offer a level of care equal to before making a search. or exceeding the standards and regula- (b) The police or other law officer tions, as determined by APHIS, even if shall abide by all security measures re- the persons or facilities are not li- quired by the dealer, exhibitor, inter- censed by or registered with APHIS; or mediate handler or carrier to prevent (3) Euthanized. the spread of disease, including the use (d) The dealer, exhibitor, inter- of sterile clothing, footwear, and mediate handler, or carrier from whom masks where required, or to prevent the animals were confiscated must bear the escape of an animal. all costs incurred in performing the § 2.129 Confiscation and destruction of placement or euthanasia activities au- animals. thorized by this section. (a) If an animal being held by a deal- [54 FR 36147, Aug. 31, 1989, as amended at 66 er, exhibitor, intermediate handler, or FR 239, Jan. 3, 2001] by a carrier is found by an APHIS official to be suffering as a result of the § 2.130 Minimum age requirements. failure of the dealer, exhibitor, inter- No dog or cat shall be delivered by mediate handler, or carrier to comply any person to any carrier or inter- with any provision of the regulations mediate handler for transportation, in or the standards set forth in this sub- commerce, or shall be transported in chapter, the APHIS official shall make commerce by any person, except to a a reasonable effort to notify the dealer, registered research facility, unless exhibitor, intermediate handler, or car- such dog or cat is at least eight (8) rier of the condition of the animal(s) weeks of age and has been weaned. and request that the condition be corrected and that adequate care be given § 2.131 Handling of animals. to alleviate the animal’s suffering or distress, or that the animal(s) be de- (a) All licensees who maintain wild stroyed by euthanasia. In the event or exotic animals must demonstrate that the dealer, exhibitor, inter- adequate experience and knowledge of mediate handler, or carrier refuses to the species they maintain. comply with this request, the APHIS (b)(1) Handling of all animals shall be official may confiscate the animal(s) done as expeditiously and carefully as for care, treatment, or disposal as indi- possible in a manner that does not cated in paragraph (b) of this section, cause trauma, overheating, excessive if, in the opinion of the Administrator, cooling, behavioral stress, physical the circumstances indicate the ani- harm, or unnecessary discomfort. mal’s health is in danger. (2)(i) Physical abuse shall not be used (b) In the event that the APHIS offi- to train, work, or otherwise handle ani- cial is unable to locate or notify the mals. dealer, exhibitor, intermediate han- (ii) Deprivation of food or water shall dler, or carrier as required in this sec- not be used to train, work, or otherwise tion, the APHIS official shall contact a handle animals; Provided, however, local police or other law officer to ac- That the short-term withholding of company him to the premises and shall food or water from animals by exhibi- provide for adequate care when nec- tors is allowed by these regulations as essary to alleviate the animal’s suf- long as each of the animals affected re- fering. If in the opinion of the Adminis- ceives its full dietary and nutrition re- trator, the condition of the animal(s) quirements each day. cannot be corrected by this temporary (c)(1) During public exhibition, any care, the APHIS official shall con- animal must be handled so there is fiscate the animals. minimal risk of harm to the animal

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and to the public, with sufficient dis- (1) Other dealers who are licensed tance and/or barriers between the ani- under the Act and in accordance with mal and the general viewing public so the regulations in part 2; as to assure the safety of animals and (2) State, county, or city owned and the public. operated animal pounds or shelters; (2) Performing animals shall be al- and lowed a rest period between perform- (3) A legal entity organized and oper- ances at least equal to the time for one ated under the laws of the State in performance. which it is located as an animal pound (3) Young or immature animals shall or shelter, such as a humane shelter or not be exposed to rough or excessive contract pound. public handling or exhibited for periods (b) No person shall obtain live dogs, of time which would be detrimental to cats, or other animals by use of false their health or well-being. pretenses, misrepresentation, or deception. (4) Drugs, such as tranquilizers, shall (c) Any dealer, exhibitor, research fa- not be used to facilitate, allow, or pro- cility, carrier, or intermediate handler vide for public handling of the animals. who also operates a private or contract (d)(1) Animals shall be exhibited only animal pound or shelter shall comply for periods of time and under condi- with the following: tions consistent with their good health (1) The animal pound or shelter shall and well-being. be located on premises that are phys- (2) A responsible, knowledgeable, and ically separated from the licensed or readily identifiable employee or at- registered facility. The animal housing tendant must be present at all times facility of the pound or shelter shall during periods of public contact. not be adjacent to the licensed or reg- (3) During public exhibition, dan- istered facility. gerous animals such as lions, tigers, (2) Accurate and complete records wolves, bears, or elephants must be shall be separately maintained by the under the direct control and super- licensee or registrant and by the pound vision of a knowledgeable and experi- or shelter. The records shall be in ac- enced animal handler. cordance with §§ 2.75 and 2.76, unless (4) If public feeding of animals is al- the animals are lost or stray. If the lowed, the food must be provided by animals are lost or stray, the pound or the animal facility and shall be appro- shelter records shall provide: priate to the type of animal and its nu- (i) An accurate description of the ani- tritional needs and diet. mal; (e) When climatic conditions present (ii) How, where, from whom, and a threat to an animal’s health or well- when the dog or cat was obtained; being, appropriate measures must be (iii) How long the dog or cat was held taken to alleviate the impact of those by the pound or shelter before being conditions. An animal may never be transferred to the dealer; and subjected to any combination of tem- (iv) The date the dog or cat was perature, humidity, and time that is transferred to the dealer. detrimental to the animal’s health or (3) Any dealer who obtains or ac- well-being, taking into consideration quires a live dog or cat from a private such factors as the animal’s age, spe- or contract pound or shelter, including a pound or shelter he or she operates, cies, breed, overall health status, and shall hold the dog or cat for a period of acclimation. at least 10 full days, not including the [54 FR 36147, Aug. 31, 1989, as amended at 63 day of acquisition, excluding time in FR 10498, Mar. 4, 1998; 69 FR 42102, July 14, transit, after acquiring the animal, and 2004] otherwise in accordance with § 2.101. (d) No dealer or exhibitor shall know- § 2.132 Procurement of dogs, cats, and ingly obtain any dog, cat, or other ani- other animals; dealers. mal from any person who is required to (a) A class ‘‘B’’ dealer may obtain be licensed but who does not hold a live random source dogs and cats only current, valid, and unsuspended li- from: cense. No dealer or exhibitor shall

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knowingly obtain any dog or cat from (i) The species and breed or type (for any person who is not licensed, other mixed breeds, estimate the two domi- than a pound or shelter, without ob- nant breeds or types); taining a certification that the animals (ii) The sex; were born and raised on that person’s (iii) The date of birth or, if unknown, premises and, if the animals are for re- then the approximate age; search purposes, that the person has (iv) The color and any distinctive sold fewer than 25 dogs and/or cats that markings; and year, or, if the animals are for use as (v) The Official USDA-approved iden- pets, that the person does not maintain tification number of the animal. How- more than three breeding female dogs ever, if the certification is attached to and/or cats. a certificate provided by a prior dealer which contains the required descrip- (Approved by the Office of Management and Budget under control number 0579–0254) tion, then only the official identification numbers are required; [54 FR 36147, Aug. 31, 1989, as amended at 69 (4) The name and address of the per- FR 42102, July 14, 2004] son, pound, or shelter from which the dog or cat was acquired by the dealer, § 2.133 Certification for random source dogs and cats. and an assurance that the person, pound, or shelter was notified that the (a) Each of the entities listed in para- cat or dog might be used for research graphs (a)(1) through (a)(3) of this sec- or educational purposes; tion that acquire any live dog or cat (5) The date the dealer acquired the shall, before selling or providing the dog or cat from the person, pound, or live dog or cat to a dealer, hold and shelter referred to in paragraph (b)(4) care for the dog or cat for a period of of this section; and not less than 5 full days after acquiring (6) If the dealer acquired the dog or the animal, not including the date of cat from a pound or shelter, a signed acquisition and excluding time in tran- statement by the pound or shelter that sit. This holding period shall include at it met the requirements of paragraph least one Saturday. The provisions of (a) of this section. This statement this paragraph apply to: must at least describe the animals by (1) Each pound or shelter owned and their official USDA identification num- operated by a State, county, or city; bers. It may be incorporated within the (2) Each private pound or shelter es- certification if the dealer makes the tablished for the purpose of caring for certification at the time that the ani- animals, such as a humane society, or mals are acquired from the pound or other organization that is under con- shelter or it may be made separately tract with a State, county, or city, and attached to the certification later. that operates as a pound or shelter, and If made separately, it must include the that releases animals on a voluntary same information describing each ani- basis; and mal as is required in the certification. (3) Each research facility licensed by A photocopy of the statement will be USDA as a dealer. regarded as a duplicate original. (b) A dealer shall not sell, provide, or (c) The original certification required make available to any person a live under paragraph (b) of this section random source dog or cat unless the shall accompany the shipment of a live dealer provides the recipient of the dog dog or cat to be sold, provided, or oth- or cat with certification that contains erwise made available by the dealer. the following information: (d) A dealer who acquires a live dog (1) The name, address, USDA license or cat from another dealer must obtain number, and signature of the dealer; from that dealer the certification re- (2) The name, address, USDA license quired by paragraph (b) of this section or registration number, if such number and must attach that certification (in- exists, and signature of the recipient of cluding any previously attached cer- the dog or cat; tification) to the certification which he (3) A description of each dog or cat or she provides pursuant to paragraph being sold, provided, or made available (b) of this section (a photocopy of the that shall include: original certification will be deemed a

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duplicate original if the dealer does not but not limited to, detailed animal dispose of all of the dogs or cats in a evacuation instructions or shelter-in- single transaction). place instructions and provisions for (e) A dealer who completes, provides, providing backup sources of food and or receives a certification required water as well as sanitation, ventila- under paragraph (b) of this section tion, bedding, veterinary care, etc.; shall keep, maintain, and make avail- (3) Identify a chain of command and able for APHIS inspection a copy of the who (by name or by position title) will certification for at least 1 year fol- be responsible for fulfilling these tasks; lowing disposition. and (f) A research facility which acquires (4) Address how response and recov- any live random source dog or cat from ery will be handled in terms of mate- a dealer must obtain the certification rials, resources, and training needed. required under paragraph (b) of this (b) For current licensees and reg- section and shall keep, maintain, and istrants, the contingency plan must be make available for APHIS inspection in place by July 29, 2013. For new deal- the original for at least 3 years fol- ers, exhibitors, intermediate handlers, lowing disposition. and carriers licensed or registered after (g) In instances where a research fa- this date, the contingency plan must cility transfers ownership of a live ran- be in place prior to conducting regu- dom source dog or cat acquired from a lated activities. The plan must be re- dealer to another research facility, a viewed by the dealer, exhibitor, inter- copy of the certification required by mediate handler, or carrier on at least paragraph (b) of this section must ac- an annual basis to ensure that it ade- company the dog or cat transferred. quately addresses the criteria listed in The research facility to which the dog paragraph (a) of this section. Each li- or cat is transferred shall keep, main- censee and registrant must maintain tain, and make available for APHIS in- documentation of their annual reviews, spection the copy of the certification including documenting any amend- for at least 3 years following disposi- ments or changes made to their plan tion. since the previous year’s review, such [58 FR 39129, July 22, 1993] as changes made as a result of recently predicted, but historically unforeseen, § 2.134 Contingency planning. circumstances (e.g., weather extremes). (a) Dealers, exhibitors, intermediate Contingency plans, as well as all an- handlers, and carriers must develop, nual review documentation and train- document, and follow an appropriate ing records, must be made available to plan to provide for the humane han- APHIS upon request. Traveling entities dling, treatment, transportation, hous- must carry a copy of their contingency ing, and care of their animals in the plan with them at all times and make event of an emergency or disaster (one it available for APHIS inspection while which could reasonably be anticipated in travel status. Dealers, exhibitors, in- and expected to be detrimental to the termediate handlers, and carriers good health and well-being of the ani- maintaining or otherwise handling ma- mals in their possession). Such contin- rine mammals in captivity must also gency plans must: comply with the requirements of (1) Identify situations the licensee or § 3.101(b) of this subchapter. registrant might experience that would (c) Dealers, exhibitors, intermediate trigger the need for the measures iden- handlers, and carriers must provide tified in a contingency plan to be put and document participation in and suc- into action including, but not limited cessful completion of training for per- to, emergencies such as electrical out- sonnel regarding their roles and re- ages, faulty HVAC systems, fires, me- sponsibilities as outlined in the plan. chanical breakdowns, and animal es- For current licensees and registrants, capes, as well as natural disasters most training of dealer, exhibitor, inter- likely to be experienced; mediate handler, and carrier personnel (2) Outline specific tasks required to must be completed by September 27, be carried out in response to the identi- 2013. For new dealers, exhibitors, inter- fied emergencies or disasters including, mediate handlers, or carriers licensed

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or registered after July 29, 2013, train- 3.19 Handling. ing of personnel must be completed within 60 days of the dealer, exhibitor, Subpart B—Specifications for the Humane intermediate handler, or carrier put- Handling, Care, Treatment, and Trans- ting their contingency plan in place. portation of Guinea Pigs and Hamsters Employees hired 30 days or more before FACILITIES AND OPERATING STANDARDS their contingency plan is put in place 3.25 Facilities, general. must also be trained by that date. For 3.26 Facilities, indoor. employees hired less than 30 days be- 3.27 Facilities, outdoor. fore that date or after that date, train- 3.28 Primary enclosures. ing must be conducted within 30 days of their start date. Any changes to the ANIMAL HEALTH AND HUSBANDRY STANDARDS plan as a result of the annual review 3.29 Feeding. must be communicated to employees 3.30 Watering. through training which must be con- 3.31 Sanitation. ducted within 30 days of making the 3.32 Employees. changes. 3.33 Classification and separation. 3.34 [Reserved] [77 FR 76823, Dec. 31, 2012]

EFFECTIVE DATE NOTE: At 77 FR 76823, Dec. TRANSPORTATION STANDARDS 31, 2012, § 2.134 was added, effective Jan. 30, 3.35 Consignments to carriers and inter- 2013. mediate handlers. 3.36 Primary enclosures used to transport PART 3—STANDARDS live guinea pigs and hamsters. 3.37 Primary conveyances (motor vehicle, Subpart A—Specifications for the Humane rail, air, and marine). Handling, Care, Treatment, and Trans- 3.38 Food and water requirements. portation of Dogs and Cats 3.39 Care in transit. 3.40 Terminal facilities. FACILITIES AND OPERATING STANDARDS 3.41 Handling.

Sec. Subpart C—Specifications for the Humane 3.1 Housing facilities, general. Handling, Care, Treatment and Trans- 3.2 Indoor housing facilities. portation of Rabbits 3.3 Sheltered housing facilities. 3.4 Outdoor housing facilities. FACILITIES AND OPERATING STANDARDS 3.5 Mobile or traveling housing facilities. 3.50 Facilities, general. 3.6 Primary enclosures. 3.51 Facilities, indoor. ANIMAL HEALTH AND HUSBANDRY STANDARDS 3.52 Facilities, outdoor. 3.53 Primary enclosures. 3.7 Compatible grouping. 3.8 Exercise for dogs. ANIMAL HEALTH AND HUSBANDRY STANDARDS 3.9 Feeding. 3.54 Feeding. 3.10 Watering. 3.55 Watering. 3.11 Cleaning, sanitization, housekeeping, 3.56 Sanitation. and pest control. 3.57 Employees. 3.12 Employees. 3.58 Classification and separation. TRANSPORTATION STANDARDS 3.59 [Reserved]

3.13 Consignments to carriers and inter- TRANSPORTATION STANDARDS mediate handlers. 3.60 Consignments to carriers and inter- 3.14 Primary enclosures used to transport mediate handlers. live dogs and cats. 3.61 Primary enclosures used to transport 3.15 Primary conveyances (motor vehicle, live rabbits. rail, air, and marine). 3.62 Primary conveyances (motor vehicle, 3.16 Food and water requirements. rail, air, and marine). 3.17 Care in transit. 3.63 Food and water requirements. 3.18 Terminal facilities. 3.64 Care in transit. 3.65 Terminal facilities.

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3.66 Handling. 3.116 Care in transit. 3.117 Terminal facilities. Subpart D—Specifications for the Humane 3.118 Handling. Handling, Care, Treatment, and Trans- portation of Nonhuman Primates Subpart F—Specifications for the Humane Handling, Care, Treatment, and Trans- FACILITIES AND OPERATING STANDARDS portation of Warmblooded Animals 3.75 Housing facilities, general. Other Than Dogs, Cats, Rabbits, Ham- 3.76 Indoor housing facilities. sters, Guinea Pigs, Nonhuman Pri- 3.77 Sheltered housing facilities. mates, and Marine Mammals 3.78 Outdoor housing facilities. 3.79 Mobile or traveling housing facilities. FACILITIES AND OPERATING STANDARDS 3.80 Primary enclosures. 3.125 Facilities, general. 3.81 Environment enhancement to promote 3.126 Facilities, indoor. psychological well-being. 3.127 Facilities, outdoor. ANIMAL HEALTH AND HUSBANDRY STANDARDS 3.128 Space requirements.

3.82 Feeding. ANIMAL HEALTH AND HUSBANDRY STANDARDS 3.83 Watering. 3.129 Feeding. 3.84 Cleaning, sanitization, housekeeping, 3.130 Watering. and pest control. 3.131 Sanitation. 3.85 Employees. 3.132 Employees. TRANSPORTATION STANDARDS 3.133 Separation. 3.134–3.135 [Reserved] 3.86 Consignments to carriers and intermediate handlers. TRANSPORTATION STANDARDS 3.87 Primary enclosures used to transport 3.136 Consignments to carriers and inter- nonhuman primates. mediate handlers. 3.88 Primary conveyances (motor vehicle, 3.137 Primary enclosures used to transport rail, air, and marine). live animals. 3.89 Food and water requirements. 3.138 Primary conveyances (motor vehicle, 3.90 Care in transit. rail, air, and marine). 3.91 Terminal facilities. 3.139 Food and water requirements. 3.92 Handling. 3.140 Care in transit. 3.141 Terminal facilities. Subpart E—Specifications for the Humane 3.142 Handling. Handling, Care, Treatment, and Trans- portation of Marine Mammals AUTHORITY: 7 U.S.C. 2131–2159; 7 CFR 2.22, 2.80, and 371.7. FACILITIES AND OPERATING STANDARDS SOURCE: 32 FR 3273, Feb. 24, 1967, unless 3.100 Special considerations regarding com- otherwise noted. pliance and/or variance. 3.101 Facilities, general. 3.102 Facilities, indoor. Subpart A—Specifications for the 3.103 Facilities, outdoor. Humane Handling, Care, 3.104 Space requirements. Treatment, and Transportation 1 ANIMAL HEALTH AND HUSBANDRY STANDARDS of Dogs and Cats 3.105 Feeding. SOURCE: 56 FR 6486, Feb. 15, 1991, unless 3.106 Water quality. 3.107 Sanitation. otherwise noted. 3.108 Employees or attendants. 3.109 Separation. FACILITIES AND OPERATING STANDARDS 3.110 Veterinary care. 3.111 Swim-with-the-dolphin programs. § 3.1 Housing facilities, general. (a) Structure; construction. Housing TRANSPORTATION STANDARDS facilities for dogs and cats must be de- 3.112 Consignments to carriers and inter- signed and constructed so that they are mediate handlers. structurally sound. They must be kept 3.113 Primary enclosures used to transport in good repair, and they must protect marine mammals. 3.114 Primary conveyances (motor vehicle, the animals from injury, contain the rail, air, and marine). 3.115 Food and drinking water require- 1 These minimum standards apply only to ments. live dogs and cats, unless stated otherwise.

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animals securely, and restrict other sand, gravel, grass, or other similar animals from entering. material must be raked or spot-cleaned (b) Condition and site. Housing facili- with sufficient frequency to ensure all ties and areas used for storing animal animals the freedom to avoid contact food or bedding must be free of any ac- with excreta. Contaminated material cumulation of trash, waste material, must be replaced whenever this raking junk, weeds, and other discarded mate- and spot-cleaning is not sufficient to rials. Animal areas inside of housing prevent or eliminate odors, insects, facilities must be kept neat and free of pests, or vermin infestation. All other clutter, including equipment, fur- surfaces of housing facilities must be niture, and stored material, but may cleaned and sanitized when necessary contain materials actually used and to satisfy generally accepted hus- necessary for cleaning the area, and bandry standards and practices. Saniti- fixtures or equipment necessary for zation may be done using any of the proper husbandry practices and re- methods provided in § 3.11(b)(3) for pri- search needs. Housing facilities other mary enclosures. than those maintained by research facilities and Federal research facilities (d) Water and electric power. The hous- must be physically separated from any ing facility must have reliable electric other business. If a housing facility is power adequate for heating, cooling, located on the same premises as an- ventilation, and lighting, and for car- other business, it must be physically rying out other husbandry require- separated from the other business so ments in accordance with the regula- that animals the size of dogs, skunks, tions in this subpart. The housing fa- and raccoons are prevented from enter- cility must provide adequate running ing it. potable water for the dogs’ and cats’ (c) Surfaces—(1) General requirements. drinking needs, for cleaning, and for The surfaces of housing facilities—in- carrying out other husbandry require- cluding houses, dens, and other fur- ments. niture-type fixtures and objects within (e) Storage. Supplies of food and bed- the facility—must be constructed in a ding must be stored in a manner that manner and made of materials that protects the supplies from spoilage, allow them to be readily cleaned and contamination, and vermin infestation. sanitized, or removed or replaced when The supplies must be stored off the worn or soiled. Interior surfaces and floor and away from the walls, to allow any surfaces that come in contact with cleaning underneath and around the dogs or cats must: supplies. Foods requiring refrigeration (i) Be free of excessive rust that pre- must be stored accordingly, and all vents the required cleaning and saniti- food must be stored in a manner that zation, or that affects the structural prevents contamination and deteriora- strength of the surface; and tion of its nutritive value. All open (ii) Be free of jagged edges or sharp supplies of food and bedding must be points that might injure the animals. kept in leakproof containers with (2) Maintenance and replacement of tightly fitting lids to prevent contami- surfaces. All surfaces must be main- nation and spoilage. Only food and bed- tained on a regular basis. Surfaces of housing facilities—including houses, ding that is currently being used may dens, and other furniture-type fixtures be kept in the animal areas. Sub- and objects within the facility—that stances that are toxic to the dogs or cannot be readily cleaned and sani- cats but are required for normal hus- tized, must be replaced when worn or bandry practices must not be stored in soiled. food storage and preparation areas, but (3) Cleaning. Hard surfaces with may be stored in cabinets in the ani- which the dogs or cats come in contact mal areas. must be spot-cleaned daily and sani- (f) Drainage and waste disposal. Hous- tized in accordance with § 3.11(b) of this ing facility operators must provide for subpart to prevent accumulation of ex- regular and frequent collection, re- creta and reduce disease hazards. moval, and disposal of animal and food Floors made of dirt, absorbent bedding, wastes, bedding, debris, garbage, water,

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other fluids and wastes, and dead ani- solid resting boards, or other methods mals, in a manner that minimizes con- of conserving body heat must be pro- tamination and disease risks. Housing vided when temperatures are below 50 facilities must be equipped with dis- °F (10 °C). The ambient temperature posal facilities and drainage systems must not fall below 45 °F (7.2 °C) for that are constructed and operated so more than 4 consecutive hours when that animal waste and water are rap- dogs or cats are present, and must not idly eliminated and animals stay dry. rise above 85 °F (29.5 °C) for more than Disposal and drainage systems must 4 consecutive hours when dogs or cats minimize vermin and pest infestation, are present. The preceding require- insects, odors, and disease hazards. All ments are in addition to, not in place drains must be properly constructed, of, all other requirements pertaining to installed, and maintained. If closed climatic conditions in parts 2 and 3 of drainage systems are used, they must this chapter. be equipped with traps and prevent the backflow of gases and the backup of (b) Ventilation. Indoor housing facili- sewage onto the floor. If the facility ties for dogs and cats must be suffi- uses sump or settlement ponds, or ciently ventilated at all times when other similar systems for drainage and dogs or cats are present to provide for animal waste disposal, the system their health and well-being, and to must be located far enough away from minimize odors, drafts, ammonia lev- the animal area of the housing facility els, and moisture condensation. Ven- to prevent odors, diseases, pests, and tilation must be provided by windows, vermin infestation. Standing puddles of vents, fans, or air conditioning. Auxil- water in animal enclosures must be iary ventilation, such as fans, blowers, drained or mopped up so that the ani- or air conditioning must be provided mals stay dry. Trash containers in when the ambient temperature is 85 °F housing facilities and in food storage (29.5 °C) or higher. The relative humid- and food preparation areas must be ity must be maintained at a level that leakproof and must have tightly fitted ensures the health and well-being of lids on them at all times. Dead ani- the dogs or cats housed therein, in ac- mals, animal parts, and animal waste cordance with the directions of the at- must not be kept in food storage or tending veterinarian and generally ac- food preparation areas, food freezers, cepted professional and husbandry food refrigerators, or animal areas. practices. (g) Washrooms and sinks. Washing fa- (c) Lighting. Indoor housing facilities cilities such as washrooms, basins, for dogs and cats must be lighted well sinks, or showers must be provided for enough to permit routine inspection animal caretakers and must be readily and cleaning of the facility, and obser- accessible. vation of the dogs and cats. Animal § 3.2 Indoor housing facilities. areas must be provided a regular diurnal lighting cycle of either natural or (a) Heating, cooling, and temperature. artificial light. Lighting must be uni- Indoor housing facilities for dogs and formly diffused throughout animal fa- cats must be sufficiently heated and cilities and provide sufficient illumina- cooled when necessary to protect the dogs and cats from temperature or hu- tion to aid in maintaining good house- midity extremes and to provide for keeping practices, adequate cleaning, their health and well-being. When dogs adequate inspection of animals, and for or cats are present, the ambient tem- the well-being of the animals. Primary perature in the facility must not fall enclosures must be placed so as to pro- below 50 °F (10 °C) for dogs and cats not tect the dogs and cats from excessive acclimated to lower temperatures, for light. those breeds that cannot tolerate lower (d) Interior surfaces. The floors and temperatures without stress or discom- walls of indoor housing facilities, and fort (such as short-haired breeds), and any other surfaces in contact with the for sick, aged, young, or infirm dogs animals, must be impervious to mois- and cats, except as approved by the at- ture. The ceilings of indoor housing fa- tending veterinarian. Dry bedding, cilities must be impervious to moisture

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or be replaceable (e.g., a suspended uniformly diffused throughout animal ceiling with replaceable panels). facilities and provide sufficient illu- [56 FR 6486, Feb. 15, 1991, as amended at 63 mination to aid in maintaining good FR 10498, Mar. 4, 1998] housekeeping practices, adequate cleaning, adequate inspection of ani- § 3.3 Sheltered housing facilities. mals, and for the well-being of the ani- (a) Heating, cooling, and temperature. mals. Primary enclosures must be The sheltered part of sheltered housing placed so as to protect the dogs and facilities for dogs and cats must be suf- cats from excessive light. ficiently heated and cooled when nec- (d) Shelter from the elements. Dogs and essary to protect the dogs and cats cats must be provided with adequate from temperature or humidity ex- shelter from the elements at all times tremes and to provide for their health to protect their health and well-being. and well-being. The ambient tempera- The shelter structures must be large ture in the sheltered part of the facil- enough to allow each animal to sit, ity must not fall below 50 °F (10 °C) for stand, and lie in a normal manner and dogs and cats not acclimated to lower to turn about freely. temperatures, for those breeds that (e) Surfaces. (1) The following areas in cannot tolerate lower temperatures sheltered housing facilities must be without stress and discomfort (such as impervious to moisture: short-haired breeds), and for sick, aged, (i) Indoor floor areas in contact with young, or infirm dogs or cats, except as the animals; approved by the attending veteri- (ii) Outdoor floor areas in contact narian. Dry bedding, solid resting with the animals, when the floor areas boards, or other methods of conserving are not exposed to the direct sun, or body heat must be provided when tem- are made of a hard material such as peratures are below 50 °F (10 °C). The wire, wood, metal, or concrete; and ambient temperature must not fall below 45 °F (7.2 °C) for more than 4 con- (iii) All walls, boxes, houses, dens, secutive hours when dogs or cats are and other surfaces in contact with the present, and must not rise above 85 °F animals. (29.5 °C) for more than 4 consecutive (2) Outside floor areas in contact hours when dogs or cats are present. with the animals and exposed to the di- The preceding requirements are in ad- rect sun may consist of compacted dition to, not in place of, all other re- earth, absorbent bedding, sand, gravel, quirements pertaining to climatic con- or grass. ditions in parts 2 and 3 of this chapter. [56 FR 6486, Feb. 15, 1991, as amended at 63 (b) Ventilation. The enclosed or shel- FR 10498, Mar. 4, 1998] tered part of sheltered housing facilities for dogs and cats must be suffi- § 3.4 Outdoor housing facilities. ciently ventilated when dogs or cats (a) Restrictions. (1) The following cat- are present to provide for their health egories of dogs or cats must not be and well-being, and to minimize odors, drafts, ammonia levels, and moisture kept in outdoor facilities, unless that condensation. Ventilation must be pro- practice is specifically approved by the vided by windows, doors, vents, fans, or attending veterinarian: air conditioning. Auxiliary ventilation, (i) Dogs or cats that are not accli- such as fans, blowers, or air-condi- mated to the temperatures prevalent in tioning, must be provided when the the area or region where they are ambient temperature is 85 °F (29.5 °C) maintained; or higher. (ii) Breeds of dogs or cats that cannot (c) Lighting. Sheltered housing facili- tolerate the prevalent temperatures of ties for dogs and cats must be lighted the area without stress or discomfort well enough to permit routine inspec- (such as short-haired breeds in cold cli- tion and cleaning of the facility, and mates); and observation of the dogs and cats. Ani- (iii) Sick, infirm, aged or young dogs mal areas must be provided a regular or cats. diurnal lighting cycle of either natural (2) When their acclimation status is or artificial light. Lighting must be unknown, dogs and cats must not be

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kept in outdoor facilities when the am- provide for their health and well-being. bient temperature is less than 50 °F (10 The ambient temperature in the mo- °C). bile or traveling housing facility must (b) Shelter from the elements. Outdoor not fall below 50 °F (10 °C) for dogs and facilities for dogs or cats must include cats not acclimated to lower tempera- one or more shelter structures that are tures, for those breeds that cannot tol- accessible to each animal in each out- erate lower temperatures without door facility, and that are large enough stress or discomfort (such as short- to allow each animal in the shelter haired breeds), and for sick, aged, structure to sit, stand, and lie in a nor- young, or infirm dogs and cats. Dry mal manner, and to turn about freely. bedding, solid resting boards, or other In addition to the shelter structures, methods of conserving body heat must one or more separate outside areas of be provided when temperatures are shade must be provided, large enough ° ° to contain all the animals at one time below 50 F (10 C). The ambient tem- ° and protect them from the direct rays perature must not fall below 45 F (7.2 ° of the sun. Shelters in outdoor facili- C) for more than 4 consecutive hours ties for dogs or cats must contain a when dogs or cats are present, and roof, four sides, and a floor, and must: must not exceed 85 °F (29.5 °C) for more (1) Provide the dogs and cats with than 4 consecutive hours when dogs or adequate protection and shelter from cats are present. The preceding re- the cold and heat; quirements are in addition to, not in (2) Provide the dogs and cats with place of, all other requirements per- protection from the direct rays of the taining to climatic conditions in parts sun and the direct effect of wind, rain, 2 and 3 of this chapter. or snow; (b) Ventilation. Mobile or traveling (3) Be provided with a wind break and housing facilities for dogs and cats rain break at the entrance; and must be sufficiently ventilated at all (4) Contain clean, dry, bedding mate- times when dogs or cats are present to rial if the ambient temperature is provide for the health and well-being of ° ° below 50 F (10 C). Additional clean, the animals, and to minimize odors, dry bedding is required when the tem- drafts, ammonia levels, moisture con- ° ° perature is 35 F (1.7 C) or lower. densation, and exhaust fumes. Ventila- (c) Construction. Building surfaces in tion must be provided by means of win- contact with animals in outdoor hous- dows, doors, vents, fans, or air condi- ing facilities must be impervious to tioning. Auxiliary ventilation, such as moisture. Metal barrels, cars, refrigerators or freezers, and the like must fans, blowers, or air conditioning, must not be used as shelter structures. The be provided when the ambient tempera- floors of outdoor housing facilities may ture within the animal housing area is be of compacted earth, absorbent bed- 85 °F (29.5 °C) or higher. ding, sand, gravel, or grass, and must (c) Lighting. Mobile or traveling be replaced if there are any prevalent housing facilities for dogs and cats odors, diseases, insects, pests, or must be lighted well enough to permit vermin. All surfaces must be main- proper cleaning and inspection of the tained on a regular basis. Surfaces of facility, and observation of the dogs outdoor housing facilities—including and cats. Animal areas must be pro- houses, dens, etc.—that cannot be read- vided a regular diurnal lighting cycle ily cleaned and sanitized, must be re- of either natural or artificial light. placed when worn or soiled. Lighting must be uniformly diffused throughout animal facilities and pro- § 3.5 Mobile or traveling housing facili- vide sufficient illumination to aid in ties. maintaining good housekeeping prac- (a) Heating, cooling, and temperature. tices, adequate cleaning, adequate in- Mobile or traveling housing facilities spection of animals, and for the well- for dogs and cats must be sufficiently being of the animals. heated and cooled when necessary to protect the dogs and cats from tem- [32 FR 3273, Feb. 24, 1967, as amended at 63 perature or humidity extremes and to FR 10498, Mar. 4, 1998]

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§ 3.6 Primary enclosures. structed of metal strands, the strands 1 Primary enclosures for dogs and cats must either be greater than ⁄8 of an must meet the following minimum re- inch in diameter (9 gauge) or coated quirements: with a material such as plastic or fiber- (a) General requirements. (1) Primary glass. The suspended floor of any pri- enclosures must be designed and con- mary enclosure must be strong enough structed of suitable materials so that so that the floor does not sag or bend they are structurally sound. The pri- between the structural supports. mary enclosures must be kept in good (b) Additional requirements for cats— repair. (1)Space. Each cat, including weaned (2) Primary enclosures must be con- kittens, that is housed in any primary structed and maintained so that they: enclosure must be provided minimum (i) Have no sharp points or edges that vertical space and floor space as fol- could injure the dogs and cats; lows: (ii) Protect the dogs and cats from (i) Prior to February 15, 1994 each cat injury; housed in any primary enclosure shall (iii) Contain the dogs and cats se- be provided a minimum of 21⁄2 square curely; feet of floor space; (iv) Keep other animals from enter- (ii) On and after February 15, 1994: ing the enclosure; (A) Each primary enclosure housing (v) Enable the dogs and cats to re- cats must be at least 24 in. high (60.96 main dry and clean; cm); (vi) Provide shelter and protection (B) Cats up to and including 8.8 lbs (4 from extreme temperatures and weath- kg) must be provided with at least 3.0 er conditions that may be uncomfort- ft2 (0.28 m2); able or hazardous to all the dogs and (C) Cats over 8.8 lbs (4 kg) must be cats; provided with at least 4.0 ft2 (0.37 m2); (vii) Provide sufficient shade to shel- (iii) Each queen with nursing kittens ter all the dogs and cats housed in the must be provided with an additional primary enclosure at one time; amount of floor space, based on her (viii) Provide all the dogs and cats breed and behavioral characteristics, with easy and convenient access to and in accordance with generally ac- clean food and water; cepted husbandry practices. If the addi- (ix) Enable all surfaces in contact tional amount of floor space for each with the dogs and cats to be readily nursing kitten is equivalent to less cleaned and sanitized in accordance than 5 percent of the minimum require- with § 3.11(b) of this subpart, or be re- ment for the queen, such housing must placeable when worn or soiled; be approved by the attending veteri- (x) Have floors that are constructed narian in the case of a research facil- in a manner that protects the dogs’ and ity, and, in the case of dealers and ex- cats’ feet and legs from injury, and hibitors, such housing must be ap- that, if of mesh or slatted construc- proved by the Administrator; and tion, do not allow the dogs’ and cats’ (iv) The minimum floor space re- feet to pass through any openings in quired by this section is exclusive of the floor; any food or water pans. The litter pan (xi) Provide sufficient space to allow may be considered part of the floor each dog and cat to turn about freely, space if properly cleaned and sanitized. to stand, sit, and lie in a comfortable, (2) Compatibility. All cats housed in normal position, and to walk in a nor- the same primary enclosure must be mal manner; and compatible, as determined by observa- (xii) Primary enclosures constructed tion. Not more than 12 adult noncondi- on or after February 20, 1998 and floors tioned cats may be housed in the same replaced on or after that date, must primary enclosure. Queens in heat may comply with the requirements in this not be housed in the same primary en- paragraph (a)(2). On or after January closure with sexually mature males, 21, 2000, all primary enclosures must be except for breeding. Except when main- in compliance with the requirements in tained in breeding colonies, queens this paragraph (a)(2). If the suspended with litters may not be housed in the floor of a primary enclosure is con- same primary enclosure with other

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adult cats, and kittens under 4 months mined by the attending veterinarian. If of age may not be housed in the same the additional amount of floor space primary enclosure with adult cats, for each nursing puppy is less than 5 other than the dam or foster dam. Cats percent of the minimum requirement with a vicious or aggressive disposition for the bitch, such housing must be ap- must be housed separately. proved by the attending veterinarian in (3) Litter. In all primary enclosures, a the case of a research facility, and, in receptacle containing sufficient clean the case of dealers and exhibitors, such litter must be provided to contain ex- housing must be approved by the Ad- creta and body wastes. ministrator. (4) Resting surfaces. Each primary en- (iii) The interior height of a primary closure housing cats must contain a enclosure must be at least 6 inches resting surface or surfaces that, in the higher than the head of the tallest dog aggregate, are large enough to hold all in the enclosure when it is in a normal the occupants of the primary enclosure standing position: Provided That, prior at the same time comfortably. The to February 15, 1994, each dog must be resting surfaces must be elevated, im- able to stand in a comfortable normal pervious to moisture, and be able to be position. easily cleaned and sanitized, or easily (2) Compatibility. All dogs housed in replaced when soiled or worn. Low rest- the same primary enclosure must be ing surfaces that do not allow the compatible, as determined by observa- space under them to be comfortably oc- tion. Not more than 12 adult noncondi- cupied by the animal will be counted as tioned dogs may be housed in the same part of the floor space. primary enclosure. Bitches in heat may (5) Cats in mobile or traveling shows or not be housed in the same primary en- acts. Cats that are part of a mobile or closure with sexually mature males, traveling show or act may be kept, except for breeding. Except when main- while the show or act is traveling from tained in breeding colonies, bitches one temporary location to another, in with litters may not be housed in the transport containers that comply with same primary enclosure with other all requirements of § 3.14 of this subpart adult dogs, and puppies under 4 months other than the marking requirements of age may not be housed in the same in § 3.14(a)(6) of this subpart. When the primary enclosure with adult dogs, show or act is not traveling, the cats other than the dam or foster dam. Dogs must be placed in primary enclosures with a vicious or aggressive disposition that meet the minimum requirements must be housed separately. of this section. (3) Dogs in mobile or traveling shows or (c) Additional requirements for dogs— acts. Dogs that are part of a mobile or (1) Space. (i) Each dog housed in a pri- traveling show or act may be kept, mary enclosure (including weaned pup- while the show or act is traveling from pies) must be provided a minimum one temporary location to another, in amount of floor space, calculated as transport containers that comply with follows: Find the mathematical square all requirements of § 3.14 of this subpart of the sum of the length of the dog in other than the marking requirements inches (measured from the tip of its in § 3.14(a)(6) of this subpart. When the nose to the base of its tail) plus 6 show or act is not traveling, the dogs inches; then divide the product by 144. must be placed in primary enclosures The calculation is: (length of dog in that meet the minimum requirements inches + 6) × (length of dog in inches + of this section. 6) = required floor space in square (4) Prohibited means of primary enclo- inches. Required floor space in inches/ sure. Permanent tethering of dogs is 144 = required floor space in square prohibited for use as primary enclo- feet. sure. Temporary tethering of dogs is (ii) Each bitch with nursing puppies prohibited for use as primary enclosure must be provided with an additional unless approval is obtained from amount of floor space, based on her APHIS. breed and behavioral characteristics, (d) Innovative primary enclosures and in accordance with generally ac- not precisely meeting the floor area cepted husbandry practices as deter- and height requirements provided in

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paragraphs (b)(1) and (c)(1) of this sec- must be made available to APHIS upon tion, but that provide the dogs or cats request, and, in the case of research fa- with a sufficient volume of space and cilities, to officials of any pertinent the opportunity to express species-typ- funding Federal agency. The plan, at a ical behavior, may be used at research minimum, must comply with each of facilities when approved by the Com- the following: mittee, and by dealers and exhibitors (a) Dogs housed individually. Dogs when approved by the Administrator. over 12 weeks of age, except bitches (Approved by the Office of Management and with litters, housed, held, or main- Budget under control number 0579–0093) tained by any dealer, exhibitor, or research facility, including Federal re- [56 FR 6486, Feb. 15, 1991, as amended at 62 search facilities, must be provided the FR 43275, Aug. 13, 1997; 63 FR 3023, Jan. 21, 1998; 63 FR 37482, July 13, 1998] opportunity for exercise regularly if they are kept individually in cages, ANIMAL HEALTH AND HUSBANDRY pens, or runs that provide less than two STANDARDS times the required floor space for that dog, as indicated by § 3.6(c)(1) of this § 3.7 Compatible grouping. subpart. Dogs and cats that are housed in the (b) Dogs housed in groups. Dogs over same primary enclosure must be com- 12 weeks of age housed, held, or main- patible, with the following restrictions: tained in groups by any dealer, exhibi- (a) Females in heat (estrus) may not tor, or research facility, including Fed- be housed in the same primary enclo- eral research facilities, do not require sure with males, except for breeding additional opportunity for exercise reg- purposes; ularly if they are maintained in cages, (b) Any dog or cat exhibiting a vi- pens, or runs that provide in total at cious or overly aggressive disposition least 100 percent of the required space must be housed separately; for each dog if maintained separately. (c) Puppies or kittens 4 months of Such animals may be maintained in age or less may not be housed in the compatible groups, unless: same primary enclosure with adult (1) Housing in compatible groups is dogs or cats other than their dams or not in accordance with a research pro- foster dams, except when permanently posal and the proposal has been ap- maintained in breeding colonies; proved by the research facility Com- (d) Dogs or cats may not be housed in mittee; the same primary enclosure with any (2) In the opinion of the attending other species of animals, unless they veterinarian, such housing would ad- are compatible; and versely affect the health or well-being (e) Dogs and cats that have or are of the dog(s); or suspected of having a contagious dis- (3) Any dog exhibits aggressive or vi- ease must be isolated from healthy ani- cious behavior. mals in the colony, as directed by the (c) Methods and period of providing ex- attending veterinarian. When an entire ercise opportunity. (1) The frequency, group or room of dogs and cats is method, and duration of the oppor- known to have or believed to be ex- tunity for exercise shall be determined posed to an infectious agent, the group by the attending veterinarian and, at may be kept intact during the process research facilities, in consultation with of diagnosis, treatment, and control. and approval by the Committee. (2) Dealers, exhibitors, and research § 3.8 Exercise for dogs. facilities, in developing their plan, Dealers, exhibitors, and research fa- should consider providing positive cilities must develop, document, and physical contact with humans that en- follow an appropriate plan to provide courages exercise through play or dogs with the opportunity for exercise. other similar activities. If a dog is In addition, the plan must be approved housed, held, or maintained at a facil- by the attending veterinarian. The ity without sensory contact with an- plan must include written standard other dog, it must be provided with procedures to be followed in providing positive physical contact with humans the opportunity for exercise. The plan at least daily.

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(3) The opportunity for exercise may veterinary care. The food must be be provided in a number of ways, such uncontaminated, wholesome, palat- as: able, and of sufficient quantity and nu- (i) Group housing in cages, pens or tritive value to maintain the normal runs that provide at least 100 percent condition and weight of the animal. of the required space for each dog if The diet must be appropriate for the maintained separately under the min- individual animal’s age and condition. imum floor space requirements of (b) Food receptacles must be used for § 3.6(c)(1) of this subpart; dogs and cats, must be readily acces- (ii) Maintaining individually housed sible to all dogs and cats, and must be dogs in cages, pens, or runs that pro- located so as to minimize contamina- vide at least twice the minimum floor tion by excreta and pests, and be pro- space required by § 3.6(c)(1) of this sub- tected from rain and snow. Feeding part; pans must either be made of a durable (iii) Providing access to a run or open material that can be easily cleaned and area at the frequency and duration pre- sanitized or be disposable. If the food scribed by the attending veterinarian; receptacles are not disposable, they or must be kept clean and must be sani- (iv) Other similar activities. tized in accordance with § 3.11(b) of this (4) Forced exercise methods or de- subpart. Sanitization is achieved by vices such as swimming, treadmills, or using one of the methods described in carousel-type devices are unacceptable § 3.11(b)(3) of this subpart. If the food for meeting the exercise requirements receptacles are disposable, they must of this section. be discarded after one use. Self-feeders (d) Exemptions. (1) If, in the opinion of may be used for the feeding of dry food. the attending veterinarian, it is inap- If self-feeders are used, they must be propriate for certain dogs to exercise kept clean and must be sanitized in ac- because of their health, condition, or cordance with § 3.11(b) of this subpart. well-being, the dealer, exhibitor, or re- Measures must be taken to ensure that search facility may be exempted from there is no molding, deterioration, and meeting the requirements of this sec- caking of feed. tion for those dogs. Such exemption must be documented by the attending § 3.10 Watering. veterinarian and, unless the basis for If potable water is not continually exemption is a permanent condition, available to the dogs and cats, it must must be reviewed at least every 30 days be offered to the dogs and cats as often by the attending veterinarian. as necessary to ensure their health and (2) A research facility may be ex- well-being, but not less than twice empted from the requirements of this daily for at least 1 hour each time, un- section if the principal investigator de- less restricted by the attending veteri- termines for scientific reasons set forth narian. Water receptacles must be kept in the research proposal that it is inap- clean and sanitized in accordance with propriate for certain dogs to exercise. § 3.11(b) of this subpart, and before Such exemption must be documented being used to water a different dog or in the Committee-approved proposal cat or social grouping of dogs or cats. and must be reviewed at appropriate intervals as determined by the Com- § 3.11 Cleaning, sanitization, house- mittee, but not less than annually. keeping, and pest control. (3) Records of any exemptions must (a) Cleaning of primary enclosures. Ex- be maintained and made available to creta and food waste must be removed USDA officials or any pertinent fund- from primary enclosures daily, and ing Federal agency upon request. from under primary enclosures as often (Approved by the Office of Management and as necessary to prevent an excessive Budget under control number 0579–0093) accumulation of feces and food waste, to prevent soiling of the dogs or cats § 3.9 Feeding. contained in the primary enclosures, (a) Dogs and cats must be fed at least and to reduce disease hazards, insects, once each day, except as otherwise pests and odors. When steam or water might be required to provide adequate is used to clean the primary enclosure,

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whether by hosing, flushing, or other moving the contaminated material as methods, dogs and cats must be re- necessary to prevent odors, diseases, moved, unless the enclosure is large pests, insects, and vermin infestation. enough to ensure the animals would (c) Housekeeping for premises. Prem- not be harmed, wetted, or distressed in ises where housing facilities are lo- the process. Standing water must be cated, including buildings and sur- removed from the primary enclosure rounding grounds, must be kept clean and animals in other primary enclo- and in good repair to protect the ani- sures must be protected from being mals from injury, to facilitate the hus- contaminated with water and other bandry practices required in this sub- wastes during the cleaning. The pans part, and to reduce or eliminate breed- under primary enclosures with grill- ing and living areas for rodents and type floors and the ground areas under other pests and vermin. Premises must raised runs with mesh or slatted floors be kept free of accumulations of trash, must be cleaned as often as necessary junk, waste products, and discarded to prevent accumulation of feces and matter. Weeds, grasses, and bushes food waste and to reduce disease haz- must be controlled so as to facilitate ards pests, insects and odors. cleaning of the premises and pest con- (b) Sanitization of primary enclosures trol, and to protect the health and and food and water receptacles. (1) Used well-being of the animals. primary enclosures and food and water (d) Pest control. An effective program receptacles must be cleaned and sani- for the control of insects, external tized in accordance with this section parasites affecting dogs and cats, and before they can be used to house, feed, birds and mammals that are pests, or water another dog or cat, or social must be established and maintained so grouping of dogs or cats. as to promote the health and well- (2) Used primary enclosures and food being of the animals and reduce con- and water receptacles for dogs and cats tamination by pests in animal areas. must be sanitized at least once every 2 [56 FR 6486, Feb. 15, 1991, as amended at 63 weeks using one of the methods pre- FR 3023, Jan. 21, 1998] scribed in paragraph (b)(3) of this section, and more often if necessary to § 3.12 Employees. prevent an accumulation of dirt, de- Each person subject to the Animal bris, food waste, excreta, and other dis- Welfare regulations (9 CFR parts 1, 2, ease hazards. and 3) maintaining dogs and cats must (3) Hard surfaces of primary enclo- have enough employees to carry out sures and food and water receptacles the level of husbandry practices and must be sanitized using one of the fol- care required in this subpart. The em- lowing methods: ployees who provide for husbandry and (i) Live steam under pressure; care, or handle animals, must be super- (ii) Washing with hot water (at least vised by an individual who has the 180 °F (82.2 °C)) and soap or detergent, knowledge, background, and experience as with a mechanical cage washer; or in proper husbandry and care of dogs (iii) Washing all soiled surfaces with and cats to supervise others. The em- appropriate detergent solutions and ployer must be certain that the super- disinfectants, or by using a combina- visor and other employees can perform tion detergent/disinfectant product to these standards. that accomplishes the same purpose, with a thorough cleaning of the sur- TRANSPORTATION STANDARDS faces to remove organic material, so as to remove all organic material and § 3.13 Consignments to carriers and in- mineral buildup, and to provide saniti- termediate handlers. zation followed by a clean water rinse. (a) Carriers and intermediate han- (4) Pens, runs, and outdoor housing dlers must not accept a dog or cat for areas using material that cannot be transport in commerce more than 4 sanitized using the methods provided hours before the scheduled departure in paragraph (b)(3) of this section, such time of the primary conveyance on as gravel, sand, grass, earth, or absorb- which the animal is to be transported. ent bedding, must be sanitized by re- However, a carrier or intermediate

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handler may agree with anyone con- before delivery of the animal to the signing a dog or cat to extend this time carrier or intermediate handler for by up to 2 hours. transport in commerce, certifying that (b) Carriers and intermediate han- the animal is acclimated to tempera- dlers must not accept a dog or cat for tures lower than those required in transport in commerce unless they are §§ 3.18 and 3.19 of this subpart. Even if provided with the name, address, and the carrier or intermediate handler re- telephone number of the consignee. ceives this certification, the tempera- (c) Carriers and intermediate han- tures the dog or cat is exposed to while dlers must not accept a dog or cat for in a terminal facility must not be transport in commerce unless the con- lower than 45 °F (2.2 °C) for more than signor certifies in writing to the car- 4 consecutive hours when dogs or cats rier or intermediate handler that the are present, as set forth in § 3.18, nor dog or cat was offered food and water lower than 45 °F (2.2 °C) for more than during the 4 hours before delivery to 45 minutes, as set forth in § 3.19, when the carrier or intermediate handler. moving dogs or cats to or from ter- The certification must be securely at- minal facilities or primary convey- tached to the outside of the primary ances. A copy of the certification must enclosure in a manner that makes it accompany the dog or cat to its des- easily noticed and read. Instructions tination and must include the fol- for no food or water are not acceptable lowing information: unless directed by the attending veteri- (1) The consignor’s name and address; narian. Instructions must be in compli- (2) The tag number or tattoo assigned ance with § 3.16 of this subpart. The to each dog or cat under §§ 2.38 and 2.50 certification must include the fol- of this chapter; lowing information for each dog and (3) A statement by a veterinarian, cat: dated no more than 10 days before de- (1) The consignor’s name and address; livery, that to the best of his or her (2) The tag number or tattoo assigned knowledge, each of the dogs or cats to each dog or cat under §§ 2.38 and 2.50 of this chapter; contained in the primary enclosure is acclimated to air temperatures lower (3) The time and date the animal was ° ° last fed and watered and the specific than 50 F (10 C); but not lower than a instructions for the next feeding(s) and minimum temperature, specified on a watering(s) for a 24-hour period; and certificate, that the attending veteri- (4) The consignor’s signature and the narian has determined is based on gen- date and time the certification was erally accepted temperature standards signed. for the age, condition, and breed of the (d) Carriers and intermediate han- dog or cat; and dlers must not accept a dog or cat for (4) The signature of the veterinarian transport in commerce in a primary and the date the certification was enclosure unless the primary enclosure signed. meets the requirements of § 3.14 of this (f) When a primary enclosure con- subpart. A carrier or intermediate han- taining a dog or cat has arrived at the dler must not accept a dog or cat for animal holding area at a terminal fa- transport if the primary enclosure is cility after transport, the carrier or in- obviously defective or damaged and termediate handler must attempt to cannot reasonably be expected to safe- notify the consignee upon arrival and ly and comfortably contain the dog or at least once in every 6-hour period cat without causing suffering or injury. thereafter. The time, date, and method (e) Carriers and intermediate han- of all attempted notifications and the dlers must not accept a dog or cat for actual notification of the consignee, transport in commerce unless their and the name of the person who noti- animal holding area meets the min- fies or attempts to notify the consignee imum temperature requirements pro- must be written either on the carrier’s vided in §§ 3.18 and 3.19 of this subpart, or intermediate handler’s copy of the or unless the consignor provides them shipping document or on the copy that with a certificate signed by a veteri- accompanies the primary enclosure. If narian and dated no more than 10 days the consignee cannot be notified within

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24 hours after the dog or cat has ar- (4) The dog or cat can be easily and rived at the terminal facility, the car- quickly removed from the enclosure in rier or intermediate handler must re- an emergency; turn the animal to the consignor or to (5) Unless the enclosure is perma- whomever the consignor designates. If nently affixed to the conveyance, ade- the consignee is notified of the arrival quate devices such as handles or and does not accept delivery of the dog handholds are provided on its exterior, or cat within 48 hours after arrival of and enable the enclosure to be lifted the dog or cat, the carrier or inter- without tilting it, and ensure that any- mediate handler must return the ani- one handling the enclosure will not mal to the consignor or to whomever come into physical contact with the the consignor designates. The carrier animal contained inside; or intermediate handler must continue (6) Unless the enclosure is perma- to provide proper care, feeding, and nently affixed to the conveyance, it is housing to the dog or cat, and main- clearly marked on top and on one or tain the dog or cat in accordance with more sides with the words ‘‘Live Ani- generally accepted professional and mals,’’ in letters at least 1 inch (2.5 husbandry practices until the con- cm.) high, and with arrows or other signee accepts delivery of the dog or markings to indicate the correct up- cat or until it is returned to the con- right position of the primary enclo- signor or to whomever the consignor sure; designates. The carrier or intermediate (7) Any material, treatment, paint, handler must obligate the consignor to preservative, or other chemical used in reimburse the carrier or intermediate or on the enclosure is nontoxic to the handler for the cost of return transpor- animal and not harmful to the health tation and care. or well-being of the animal; (Approved by the Office of Management and (8) Proper ventilation is provided to Budget under control number 0579–0093) the animal in accordance with paragraph (c) of this section; and § 3.14 Primary enclosures used to (9) The primary enclosure has a solid, transport live dogs and cats. leak-proof bottom or a removable, Any person subject to the Animal leak-proof collection tray under a slat- Welfare regulations (9 CFR parts 1, 2, ted or mesh floor that prevents seepage and 3) must not transport or deliver for of waste products, such as excreta and transport in commerce a dog or cat un- body fluids, outside of the enclosure. If less the following requirements are a slatted or mesh floor is used in the met: enclosure, it must be designed and con- (a) Construction of primary enclosures. structed so that the animal cannot put The dog or cat must be contained in a any part of its body between the slats primary enclosure such as a compart- or through the holes in the mesh. Un- ment, transport cage, carton, or crate. less the dogs and cats are on raised Primary enclosures used to transport slatted floors or raised floors made of dogs and cats must be constructed so mesh, the primary enclosure must con- that: tain enough previously unused litter to (1) The primary enclosure is strong absorb and cover excreta. The litter enough to contain the dogs and cats se- must be of a suitably absorbent mate- curely and comfortably and to with- rial that is safe and nontoxic to the stand the normal rigors of transpor- dogs and cats. tation; (b) Cleaning of primary enclosures. A (2) The interior of the primary enclo- primary enclosure used to hold or sure has no sharp points or edges and transport dogs or cats in commerce no protrusions that could injure the must be cleaned and sanitized before animal contained in it; each use in accordance with the meth- (3) The dog or cat is at all times se- ods provided in § 3.11(b)(3) of this sub- curely contained within the enclosure part. If the dogs or cats are in transit and cannot put any part of its body for more than 24 hours, the enclosures outside the enclosure in a way that must be cleaned and any litter re- could result in injury to itself, to han- placed, or other methods, such as mov- dlers, or to persons or animals nearby; ing the animals to another enclosure,

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must be utilized to prevent the soiling (3) If a primary enclosure is perma- of the dogs or cats by body wastes. If it nently affixed to the primary convey- becomes necessary to remove the dog ance so that there is only a front ven- or cat from the enclosure in order to tilation opening for the enclosure, the clean, or to move the dog or cat to an- primary enclosure must be affixed to other enclosure, this procedure must be the primary conveyance in such a way completed in a way that safeguards the that the front ventilation opening can- dog or cat from injury and prevents es- not be blocked, and the front ventila- cape. tion opening must open directly to an (c) Ventilation. (1) Unless the primary unobstructed aisle or passageway in- enclosure is permanently affixed to the side the conveyance. The ventilation conveyance, there must be: opening must be at least 90 percent of (i) Ventilation openings located on the total area of the front wall of the two opposing walls of the primary en- enclosure, and must be covered with closure and the openings must be at bars, wire mesh, or smooth expanded least 16 percent of the surface area of metal having air spaces. each such wall, and the total combined (d) Compatibility. (1) Live dogs or cats surface area of the ventilation open- transported in the same primary enclo- ings must be at least 14 percent of the sure must be of the same species and be total combined surface area of all the maintained in compatible groups, ex- walls of the primary enclosure; or cept that dogs and cats that are pri- (ii) Ventilation openings on three vate pets, are of comparable size, and walls of the primary enclosure, and the are compatible, may be transported in openings on each of the two opposing the same primary enclosure. walls must be at least 8 percent of the (2) Puppies or kittens 4 months of age total surface area of the two walls, and or less may not be transported in the the ventilation openings on the third same primary enclosure with adult wall of the primary enclosure must be dogs or cats other than their dams. at least 50 percent of the total surface (3) Dogs or cats that are overly ag- area of that wall, and the total combined surface area of the ventilation gressive or exhibit a vicious disposition openings must be at least 14 percent of must be transported individually in a the total combined surface area of all primary enclosure. the walls of the primary enclosure; or (4) Any female dog or cat in heat (iii) Ventilation openings located on (estrus) may not be transported in the all four walls of the primary enclosure same primary enclosure with any male and the ventilation openings on each of dog or cat. the four walls must be at least 8 per- (e) Space and placement. (1) Primary cent of the total surface area of each enclosures used to transport live dogs such wall, and the total combined sur- and cats must be large enough to en- face area of the openings must be at sure that each animal contained in the least 14 percent of total combined sur- primary enclosure has enough space to face area of all the walls of the primary turn about normally while standing, to enclosure; and stand and sit erect, and to lie in a nat- (iv) At least one-third of the ventila- ural position. tion area must be located on the upper (2) Primary enclosures used to trans- half of the primary enclosure. port dogs and cats must be positioned (2) Unless the primary enclosure is in the primary conveyance so as to pro- permanently affixed to the conveyance, vide protection from the elements. projecting rims or similar devices must (f) Transportation by air. (1) No more be located on the exterior of each en- than one live dog or cat, 6 months of closure wall having a ventilation open- age or older, may be transported in the ing, in order to prevent obstruction of same primary enclosure when shipped the openings. The projecting rims or via air carrier. similar devices must be large enough (2) No more than one live puppy, 8 to provide a minimum air circulation weeks to 6 months of age, and weighing space of 0.75 in. (1.9 cm) between the over 20 lbs (9 kg), may be transported primary enclosure and anything the in a primary enclosure when shipped enclosure is placed against. via air carrier.

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(3) No more than two live puppies or § 3.15 Primary conveyances (motor ve- kittens, 8 weeks to 6 months of age, hicle, rail, air, and marine). that are of comparable size, and weigh- (a) The animal cargo space of pri- ing 20 lbs (9 kg) or less each, may be mary conveyances used to transport transported in the same primary enclo- dogs and cats must be designed, con- sure when shipped via air carrier. structed, and maintained in a manner (4) Weaned live puppies or kittens that at all times protects the health less than 8 weeks of age and of com- and well-being of the animals trans- parable size, or puppies or kittens that ported in them, ensures their safety are less than 8 weeks of age that are and comfort, and prevents the entry of littermates and are accompanied by engine exhaust from the primary con- their dam, may be transported in the veyance during transportation. same primary enclosure when shipped (b) The animal cargo space must have to research facilities, including Federal a supply of air that is sufficient for the research facilities. normal breathing of all the animals (g) Transportation by surface vehicle or being transported in it. privately owned aircraft. (1) No more (c) Each primary enclosure con- than four live dogs or cats, 8 weeks of taining dogs or cats must be positioned age or older, that are of comparable in the animal cargo space in a manner size, may be transported in the same that provides protection from the ele- primary enclosure when shipped by ments and that allows each dog or cat surface vehicle (including ground and enough air for normal breathing. water transportation) or privately (d) During air transportation, dogs owned aircraft, and only if all other re- and cats must be held in cargo areas quirements of this section are met. that are heated or cooled as necessary (2) Weaned live puppies or kittens to maintain an ambient temperature less than 8 weeks of age and of com- and humidity that ensures the health parable size, or puppies or kittens that and well-being of the dogs or cats. The are less than 8 weeks of age that are cargo areas must be pressurized when littermates and are accompanied by the primary conveyance used for air their dam, may be transported in the transportation is not on the ground, same primary enclosure when shipped unless flying under 8,000 ft. Dogs and to research facilities, including Federal cats must have adequate air for breath- research facilities, and only if all other ing at all times when being trans- requirements in this section are met. ported. (h) Accompanying documents and (e) During surface transportation, records. Shipping documents that must auxiliary ventilation, such as fans, accompany shipments of dogs and cats blowers or air conditioning, must be may be held by the operator of the pri- used in any animal cargo space con- mary conveyance, for surface transpor- taining live dogs or cats when the am- tation only, or must be securely at- bient temperature within the animal tached in a readily accessible manner ° ° to the outside of any primary enclosure cargo space reaches 85 F (29.5 C). Moreover, the ambient temperature that is part of the shipment, in a man- ° ° ner that allows them to be detached for may not exceed 85 F (29.5 C) for a period of more than 4 hours; nor fall examination and securely reattached, ° ° such as in a pocket or sleeve. Instruc- below 45 F (7.2 C) for a period of more tions for administration of drugs, than 4 hours. The preceding require- medication, and other special care ments are in addition to, not in place must be attached to each primary en- of, all other requirements pertaining to closure in a manner that makes them climatic conditions in parts 2 and 3 of easy to notice, to detach for examina- this chapter. (f) Primary enclosures must be position, and to reattach securely. Food tioned in the primary conveyance in a and water instructions must be at- manner that allows the dogs and cats tached in accordance with § 3.13(c). to be quickly and easily removed from (Approved by the Office of Management and the primary conveyance in an emer- Budget under control number 0579–0093) gency. [56 FR 6486, Feb. 15, 1991, as amended at 63 (g) The interior of the animal cargo FR 3023, Jan. 21, 1998] space must be kept clean.

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(h) Live dogs and cats may not be mary enclosure and placed so that the transported with any material, sub- receptacles can be filled from outside stance (e.g., dry ice) or device in a the enclosure without opening the manner that may reasonably be ex- door. Food and water containers must pected to harm the dogs and cats or be designed, constructed, and installed cause inhumane conditions. so that a dog or cat cannot leave the primary enclosure through the food or [56 FR 6486, Feb. 15, 1991, as amended at 63 FR 10498, 10499, Mar. 4, 1998] water opening. (Approved by the Office of Management and § 3.16 Food and water requirements. Budget under control number 0579–0093) (a) Each dog and cat that is 16 weeks of age or more must be offered food at § 3.17 Care in transit. least once every 24 hours. Puppies and (a) Surface transportation (ground and kittens less than 16 weeks of age must water). Any person subject to the Ani- be offered food at least once every 12 mal Welfare regulations transporting hours. Each dog and cat must be of- dogs or cats in commerce must ensure fered potable water at least once every that the operator of the conveyance, or 12 hours. These time periods apply to a person accompanying the operator, dealers, exhibitors, research facilities. observes the dogs or cats as often as including Federal research facilities, circumstances allow, but not less than who transport dogs and cats in their once every 4 hours, to make sure they own primary conveyance, starting from have sufficient air for normal breath- the time the dog or cat was last offered ing, that the ambient temperature is food and potable water before transpor- within the limits provided in § 3.15(e), tation was begun. These time periods and that all applicable standards of apply to carriers and intermediate han- this subpart are being complied with. dlers starting from the date and time The regulated person must ensure that stated on the certificate provided the operator or person accompanying under § 3.13(c) of this subpart. Each dog the operator determines whether any and cat must be offered food and pota- of the dogs or cats are in obvious phys- ble water within 4 hours before being ical distress and obtains any veteri- transported in commerce. Consignors nary care needed for the dogs or cats at who are subject to the Animal Welfare the closest available veterinary facil- regulations (9 CFR parts 1, 2, and 3) ity. must certify that each dog and cat was (b) Air transportation. During air offered food and potable water within transportation of dogs or cats, it is the the 4 hours preceding delivery of the responsibility of the carrier to observe dog or cat to a carrier or intermediate the dogs or cats as frequently as cir- handler for transportation in com- cumstances allow, but not less than merce, and must certify the date and once every 4 hours if the animal cargo time the food and potable water was of- area is accessible during flight. If the fered, in accordance with § 3.13(c) of animal cargo area is not accessible this subpart. during flight, the carrier must observe (b) Any dealer, research facility, in- the dogs or cats whenever they are cluding a Federal research facility, or loaded and unloaded and whenever the exhibitor offering any dog or cat to a animal cargo space is otherwise acces- carrier or intermediate handler for sible to make sure they have sufficient transportation in commerce must se- air for normal breathing, that the ani- curely attach to the outside of the pri- mal cargo area meets the heating and mary enclosure used for transporting cooling requirements of § 3.15(d), and the dog or cat, written instructions for that all other applicable standards of the in-transit food and water require- this subpart are being complied with. ments for a 24-hour period for the dogs The carrier must determine whether and cats contained in the enclosure. any of the dogs or cats are in obvious The instructions must be attached in a physical distress, and arrange for any manner that makes them easily no- needed veterinary care as soon as pos- ticed and read. sible. (c) Food and water receptacles must (c) If a dog or cat is obviously ill, in- be securely attached inside the pri- jured, or in physical distress, it must

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not be transported in commerce, except hours at any time dogs or cats are to receive veterinary care for the con- present. The ambient temperature dition. must be measured in the animal hold- (d) Except during the cleaning of pri- ing area by the carrier, intermediate mary enclosures, as required in § 3.14(b) handler, or a person transporting dogs of this subpart, during transportation or cats who is subject to the Animal in commerce a dog or cat must not be Welfare regulations (9 CFR parts 1, 2, removed from its primary enclosure, and 3), outside any primary enclosure unless it is placed in another primary containing a dog or cat at a point not enclosure or facility that meets the re- more than 3 feet (0.91 m) away from an quirements of § 3.6 or § 3.14 of this sub- outside wall of the primary enclosure, part. and approximately midway up the side (e) The transportation regulations of the enclosure. The preceding re- contained in this subpart must be com- quirements are in addition to, not in plied with until a consignee takes place of, all other requirements per- physical delivery of the dog or cat if taining to climatic conditions in parts the animal is consigned for transpor- 2 and 3 of this chapter. tation, or until the animal is returned (e) Shelter. Any person subject to the to the consignor. Animal Welfare regulations (9 CFR parts 1, 2, and 3) holding a live dog or § 3.18 Terminal facilities. cat in an animal holding area of a ter- (a) Placement. Any person subject to minal facility must provide the fol- the Animal Welfare regulations (9 CFR lowing: parts 1, 2, and 3) must not commingle (1) Shelter from sunlight and extreme shipments of dogs or cats with inani- heat. Shade must be provided that is mate cargo in animal holding areas of sufficient to protect the dog or cat terminal facilities. from the direct rays of the sun. (b) Cleaning, sanitization, and pest con- (2) Shelter from rain or snow. Suffi- trol. All animal holding areas of ter- cient protection must be provided to minal facilities must be cleaned and allow the dogs and cats to remain dry sanitized in a manner prescribed in during rain, snow, and other precipita- § 3.11(b)(3) of this subpart, as often as tion. necessary to prevent an accumulation (f) Duration. The length of time any of debris or excreta and to minimize person subject to the Animal Welfare vermin infestation and disease hazards. regulations (9 CFR parts 1, 2, and 3) can Terminal facilities must follow an ef- hold dogs and cats in animal holding fective program in all animal holding areas of terminal facilities upon ar- areas for the control of insects, rival is the same as that provided in ectoparasites, and birds and mammals § 3.13(f) of this subpart. that are pests to dogs and cats. [56 FR 6486, Feb. 15, 1991, as amended at 63 (c) Ventilation. Ventilation must be FR 10499, Mar. 4, 1998] provided in any animal holding area in a terminal facility containing dogs or § 3.19 Handling. cats, by means of windows, doors, (a) Any person subject to the Animal vents, or air conditioning. The air Welfare regulations (9 CFR parts 1, 2, must be circulated by fans, blowers, or and 3) who moves (including loading air conditioning so as to minimize and unloading) dogs or cats within, to, drafts, odors, and moisture condensa- or from the animal holding area of a tion. Auxiliary ventilation, such as ex- terminal facility or a primary convey- haust fans, vents, fans, blowers, or air ance must do so as quickly and effi- conditioning must be used in any ani- ciently as possible and must provide mal holding area containing dogs and the following during movement of the cats, when the ambient temperature is dog or cat: 85 °F (29.5 °C) or higher (1) Shelter from sunlight and extreme (d) Temperature. The ambient tem- heat. Sufficient shade must be provided perature in an animal holding area to protect the dog or cat from the di- containing dogs or cats must not fall rect rays of the sun. The dog or cat below 45 °F (7.2 °C) or rise above 85 °F must not be exposed to an ambient air (29.5 °C) for more than four consecutive temperature above 85 °F (29.5 °C) for a

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period of more than 45 minutes while (c) This section applies to movement being moved to or from a primary con- of a dog or cat from primary convey- veyance or a terminal facility. The ance to primary conveyance, within a temperature must be measured in the primary conveyance or terminal facil- manner provided in § 3.18(d) of this sub- ity, and to or from a terminal facility part. The preceding requirements are or a primary conveyance. in addition to, not in place of, all other requirements pertaining to climatic (Approved by the Office of Management and Budget under control number 0579–0093) conditions in parts 2 and 3 of this chapter. [56 FR 6486, Feb. 15, 1991, as amended at 63 (2) Shelter from rain and snow. Suffi- FR 10499, Mar. 4, 1998] cient protection must be provided to allow the dogs and cats to remain dry Subpart B—Specifications for the during rain, snow, and other precipita- Humane Handling, Care, tion. Treatment, and Transportation (3) Shelter from cold temperatures. of Guinea Pigs and Hamsters Transporting devices on which live dogs or cats are placed to move them FACILITIES AND OPERATING STANDARDS must be covered to protect the animals when the outdoor temperature falls § 3.25 Facilities, general. ° ° below 50 F (10 C). The dogs or cats (a) Structural strength. Indoor and must not be exposed to an ambient outdoor housing facilities for guinea ° ° temperature below 45 F (7.2 C) for a pigs or hamsters shall be structurally period of more than 45 minutes, unless sound and shall be maintained in good they are accompanied by a certificate repair, to protect the animals from in- of acclimation to lower temperatures jury, to contain the animals, and to reas provided in § 3.13(e). The tempera- strict the entrance of other animals. ture must be measured in the manner (b) Water and electric power. Reliable provided in § 3.18(d) of this subpart. The and adequate electric power, if re- preceding requirements are in addition quired to comply with other provisions to, not in place of, all other require- of this subpart, and adequate potable ments pertaining to climatic condi- water shall be available. tions in parts 2 and 3 of this chapter. (c) Supplies of food and bed- (b) Any person handling a primary Storage. enclosure containing a dog or cat must ding shall be stored in facilities which use care and must avoid causing phys- adequately protect such supplies ical harm or distress to the dog or cat. against spoilage or deterioration and infestation or contamination by (1) A primary enclosure containing a vermin. Food supplies shall be stored live dog or cat must not be placed on in containers with tightly fitting lids unattended conveyor belts, or on ele- or covers or in the original containers vated conveyor belts, such as baggage as received from the commercial claim conveyor belts and inclined con- sources of supply. Refrigeration shall veyor ramps that lead to baggage claim be provided for supplies of perishable areas, at any time; except that a pri- food. mary enclosure may be placed on inclined conveyor ramps used to load and (d) Waste disposal. Provisions shall be unload aircraft if an attendant is made for the removal and disposal of present at each end of the conveyor animal and food wastes, bedding, dead belt. animals, and debris. Disposal facilities shall be so provided and operated as to (2) A primary enclosure containing a minimize vermin infestation, odors, dog or cat must not be tossed, dropped, and disease hazards. or needlessly tilted, and must not be stacked in a manner that may reason- (e) Washroom and sinks. Facilities, ably be expected to result in its falling. such as washrooms, basins, or sinks, It must be handled and positioned in shall be provided to maintain cleanli- the manner that written instructions ness among animal caretakers. and arrows on the outside of the pri- [32 FR 3273, Feb. 24, 1967, as amended at 44 mary enclosure indicate. FR 63492, Nov. 2, 1979]

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§ 3.26 Facilities, indoor. shelving and other accessories, shall be (a) Heating. Indoor housing facilities constructed of smooth material sub- for guinea pigs or hamsters shall be stantially impervious to liquids and sufficiently heated when necessary to moisture. protect the animals from the cold, and (2) Primary enclosures shall be con- to provide for their health and comfort. structed and maintained so that the The ambient temperature shall not be guinea pigs or hamsters contained allowed to fall below 60 °F. nor to ex- therein have convenient access to clean ceed 85 °F. food and water as required in this sub- (b) Ventilation. Indoor housing facili- part. ties for guinea pigs or hamsters shall (3) Primary enclosures having a solid be adequately ventilated to provide for floor shall be provided with clean bed- the health and comfort of the animals ding material. at all times. Such facilities shall be (4) Primary enclosures equipped with provided with fresh air either by means mesh or wire floors shall be so con- of windows, doors, vents, or air condi- structed as to allow feces to pass tioning, and shall be ventilated so as to through the spaces of the mesh or wire: minimize drafts, odors, and moisture Provided, however, That such floors condensation. The ambient tempera- shall be constructed so as to protect ture shall not be allowed to rise above the animals’ feet and legs from injury. 85 °F. (b) Space requirements for primary en- (c) Lighting. Indoor housing facilities closures acquired before August 15, 1990— for guinea pigs or hamsters shall have (1) Guinea pigs and hamsters. Primary ample light, by natural or artificial enclosures shall be constructed and means, or both, of good quality and maintained so as to provide sufficient well distributed. Such lighting shall space for each animal contained there- provide uniformly distributed illu- in to make normal postural adjust- mination of sufficient light intensity ments with adequate freedom of move- to permit routine inspection and clean- ment. ing during the entire working period. (2) Guinea pigs. In addition to the pro- Primary enclosures shall be so placed visions of paragraph (b)(1) of this sec- as to protect the guinea pigs or ham- tion, the following space requirements sters from excessive illumination. are applicable to primary enclosures (d) Interior surfaces. The interior for guinea pigs: building surfaces of indoor housing fa- (i) The interior height of any primary cilities shall be constructed and main- enclosure used to confine guinea pigs tained so that they are substantially shall be at least 61⁄2 inches. impervious to moisture and may be (ii) Each guinea pig housed in a pri- readily sanitized. mary enclosure shall be provided a minimum amount of floor space in ac- § 3.27 Facilities, outdoor. cordance with the following table: (a) Hamsters shall not be housed in Minimum outdoor facilities. space per (b) Guinea pigs shall not be housed in Weight or stage of maturity guinea pig (square outdoor facilities unless such facilities inches) are located in an appropriate climate Weaning to 350 grams ...... 60 and prior approval for such outdoor 350 grams or more ...... 90 housing is obtained from the Deputy Breeders ...... 180 Administrator. (3) Hamsters. In addition to the provi- § 3.28 Primary enclosures. sions of paragraph (b)(1) of this section, All primary enclosures for guinea the following space requirements are pigs and hamsters shall conform to the applicable to primary enclosures for following requirements: hamsters: (a) General. (1) Primary enclosures (i) The interior height of any primary shall be structurally sound and main- enclosure used to confine hamsters tained in good repair to protect the shall be at least 51⁄2 inches, except that guinea pigs and hamsters from injury. in the case of dwarf hamsters, such in- Such enclosures, including their racks, terior height shall be at least 5 inches.

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(ii) A nursing female hamster, to- shall be provided a minimum amount gether with her litter, shall be housed of floor space in any primary enclosure in a primary enclosure which contains as follows: no other hamsters and which provides Weight Minimum floor at least 121 square inches of floor space per ham- space: Provided, however, That in the ster g ozs case of dwarf hamsters such floor space in2 cm2 shall be at least 25 square inches. (iii) The minimum amount of floor <60 <2.1 10 64.52 60 to 80 2.1–2.8 13 83.88 space per individual hamster and the 80 to 100 2.8–3.5 16 103.23 maximum number of hamsters allowed >100 >3.5 19 122.59 in a single primary enclosure, except as provided for nursing females in para- (iv) A nursing female hamster, to- graph (b)(3)(ii) of this section, shall be gether with her litter, shall be housed in accordance with the following table: in a primary enclosure that contains no other hamsters and that provides at Minimum space per Maximum least 121 square inches of floor space: hamster (square population Provided, however, That in the case of Age inches) per enclosure nursing female dwarf hamsters such Dwarf Other floor space shall be at least 25 square Weaning to 5 wks ...... 5.0 10.0 20 inches. 5 to 10 wks ...... 7.5 12.5 16 (3) Innovative primary enclosures 10 wks. or more ...... 9 15.0 13 that do not precisely meet the space requirements of paragraph (c)(1) or (c) Space requirements for primary en- (c)(2) of this section, but that do pro- closures acquired on or after August 15, vide guinea pigs or hamsters with a 1990—(1) Guinea pigs. (i) Primary enclo- sufficient volume of space and the op- sures shall be constructed and main- portunity to express species-typical be- tained so as to provide sufficient space havior, may be used at research facili- for each guinea pig contained therein ties when approved by the Institutional to make normal postural adjustments Animal Care and Use Committee, and with adequte freedom of movement. by dealers and exhibitors when ap- (ii) The interior height of any pri- proved by the Administrator. mary enclosure used to confine guinea pigs shall be at least 7 inches (17.78 [32 FR 3273, Feb. 24, 1967, as amended at 55 cm). FR 28882, July 16, 1990] (iii) Each guinea pig shall be provided a minimum amount of floor ANIMAL HEALTH AND HUSBANDRY space in any primary enclosure as fol- STANDARDS lows: § 3.29 Feeding. Minimum (a) Guinea pigs and hamsters shall be Weight or stage of maturity floor space fed each day except as otherwise might in2 cm2 be required to provide adequate veterinary care. The food shall be free from Weaning to 350 grams ...... 60 387.12 >350 grams ...... 101 651.65 contamination, wholesome, palatable Nursing females with their litters ...... 101 651.65 and of sufficient quantity and nutritive value to meet the normal daily re- (2) Hamsters. (i) Primary enclosures quirements for the condition and size shall be constructed and maintained so of the guinea pig or hamster. as to provide sufficient space for each (b) Food comprising the basic diet hamster contained therein to make shall be at least equivalent in quality normal postural adjustments with ade- and content to pelleted rations pro- quate freedom of movement. duced commercially and commonly (ii) The interior height of any pri- available from feed suppliers. mary enclosure used to confine ham- (c) The basic diet of guinea pigs and sters shall be at least 6 inches (15.24 hamsters may be supplemented with cm). good quality fruits or vegetables con- (iii) Except as provided in paragraph sistent with their individual dietary re- (c)(2)(iv) of this section, each hamster quirements.

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(d) Food receptacles, if used, shall be able foods, or moisture condensation, accessible to all guinea pigs or ham- the guinea pigs or hamsters shall be sters in a primary enclosure and shall transferred to clean primary enclo- be located so as to minimize contami- sures. nation by excreta. All food receptacles (3) Prior to the introduction of guin- shall be kept clean and shall be sani- ea pigs or hamsters into empty pri- tized at least once every 2 weeks. If mary enclosures previously occupied, self-feeders are used for the feeding of such enclosures shall be sanitized in pelleted feed, measures must be taken the manner provided in paragraph to prevent molding, deterioration or (a)(4) of this section. caking of the feed. Hamsters may be (4) Primary enclosures for guinea fed pelleted feed on the floor of a pri- pigs or hamsters shall be sanitized by mary enclosure. washing them with hot water (180 °F.) (e) Fruit or vegetable food supple- and soap or detergent as in a mechan- ments may be placed upon the bedding ical cage washer, or by washing all within the primary enclosure: Provided, soiled surfaces with a detergent solu- however, That the uneaten portion of tion followed by a safe and effective such supplements and any bedding disinfectant, or by cleaning all soiled soiled as a result of such feeding prac- surfaces with live steam. tices shall be removed from the pri- (b) Housekeeping. Premises (buildings mary enclosure when such uneaten and grounds) shall be kept clean and in supplements accumulate or such bed- good repair in order to protect the ani- ding becomes soiled to a degree that mals from injury and to facilitate the might be harmful or uncomfortable to prescribed husbandry practices set animals therein. forth in this subpart. Premises shall remain free of accumulations of trash. § 3.30 Watering. (c) Pest control. An effective program Unless food supplements consumed for the control of insects, by guinea pigs or hamsters supply ectoparasites, and avian and mamma- them with their normal water require- lian pests shall be established and ments, potable water shall be provided maintained. daily except as might otherwise be required to provide adequate veterinary § 3.32 Employees. care. Open containers used for dis- A sufficient number of employees pensing water to guinea pigs or ham- shall be utilized to maintain the pre- sters shall be so placed in or attached scribed level of husbandry practices set to the primary enclosure as to mini- forth in this subpart. Such practices mize contamination from excreta. All shall be under the supervision of an watering receptacles shall be sanitized animal caretaker who has a back- when dirty: Provided, however, That ground in animal husbandry or care. such receptacles shall be sanitized at least once every 2 weeks. § 3.33 Classification and separation. Animals housed in the same primary § 3.31 Sanitation. enclosure shall be maintained in com- (a) Cleaning and sanitation of primary patible groups, with the following addi- enclosures. (1) Primary enclosures shall tional restrictions: be cleaned and sanitized often enough (a) Except where harem breeding is to prevent an accumulation of excreta practiced, preweanling guinea pigs or debris: Provided, however, That such shall not be housed in the same pri- enclosures shall be sanitized at least mary enclosure with adults other than once every 2 weeks in the manner pro- their parents. vided in paragraph (a)(4) of this sec- (b) Guinea pigs shall not be housed in tion. the same primary enclosure with ham- (2) In the event a primary enclosure sters, nor shall guinea pigs or hamsters becomes soiled or wet to a degree that be housed in the same primary enclo- might be harmful or uncomfortable to sure with any other species of animals. the animals therein due to leakage of (c) Guinea pigs or hamsters under the watering system, discharges from quarantine or treatment for a commu- dead or dying animals, spoiled perish- nicable disease shall be separated from

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other guinea pigs or hamsters and consignor, stating that the primary en- other susceptible species of animals in closure complies with § 3.36 of the such a manner as to minimize dissemi- standards, unless such primary enclo- nation of such disease. sure is obviously defective or damaged and it is apparent that it cannot rea- § 3.34 [Reserved] sonably be expected to contain the live guinea pig or hamster without causing TRANSPORTATION STANDARDS suffering or injury to such live guinea pig or hamster. A copy of such certifi- AUTHORITY: Sections 3.35 through 3.41 cate shall accompany the shipment to issued under secs. 3, 5, 6, 10, 11, 14, 16, 17, 21; 80 Stat. 353; 84 Stat. 1561, 1562, 1563, 1564; 90 destination. The certificate of compli- Stat. 418, 419, 420, 423; (7 U.S.C. 2133, 2135, ance shall include at least the fol- 2136, 2140, 2141, 2144, 2146, 2147, 2151); 37 FR lowing information: 28464, 28477, 38 FR 19141. (1) Name and address of the consignor; § 3.35 Consignments to carriers and in- (2) The number of guinea pigs or termediate handlers. hamsters in the primary enclosure(s); (a) Carriers and intermediate han- (3) A certifying statement (e.g., ‘‘I dlers shall not accept any live guinea hereby certify that the ll (number) pig or hamster presented by any dealer, primary enclosure(s) which are used to research facility, exhibitor, operator of transport the animal(s) in this ship- an auction sale, or other person, or any ment complies (comply) with USDA department, agency, or instrumen- standards for primary enclosures (9 tality of the United States or any CFR part 3).’’); and State or local government for ship- (4) The signature of the consignor, ment, in commerce, more than 4 hours and date. prior to the scheduled departure of the (c) Carriers or intermediate handlers primary conveyance on which it is to whose facilities fail to meet the min- be transported: Provided, however, That imum temperature allowed by the the carrier or intermediate handler and standards may accept for transpor- any dealer, research facility, exhibitor, tation or transport, in commerce, any operator of an auction sale, or other live hamster consigned by any depart- person, or any department, agency, or ment, agency, or instrumentality of instrumentality of the United States the United States or of any State or or any State or local government may local government, or by any person (in- mutually agree to extend the time of cluding any licensee or registrant acceptance to not more than 6 hours if under the Act, as well as any private specific prior scheduling of the animal individual) if the consignor furnishes shipment to destination has been to the carrier or intermediate handler made. a certificate executed by a veterinarian (b) Any carrier or intermediate han- accredited by this Department pursu- dler shall only accept for transpor- ant to part 160 of this title on a speci- tation or transport, in commerce any fied date which shall not be more than live guinea pig or hamster in a primary 10 days prior to delivery of such ham- enclosure which conforms to the re- ster for transportation in commerce, quirements set forth in § 3.36 of the stating that such live hamster is accli- standards: Provided, however, That any mated to air temperatures lower than carrier or intermediate handler may those prescribed in §§ 3.40 and 3.41. A accept for transportation or transport, copy of such certificate shall accom- in commerce, any live guinea pig or pany the shipment to destination. The hamster consigned by any department, certificate shall include the following agency, or instrumentality of the information: United States having laboratory ani- (1) Name and address of the con- mal facilities or exhibiting animals, or signor; any licensed or registered dealer, re- (2) The number of hamsters in the search facility, exhibitor, or operator shipment; of an auction sale, if such consignor (3) A certifying statement (e.g., ‘‘I furnishes to the carrier or intermediate hereby certify that the animal(s) in handler a certificate, signed by the this shipment is (are), to the best of

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my knowledge, acclimated to air tem- openings on each such wall shall be at peratures lower than 7.2 °C. (45 °F.).’’); least 16 percent of the total surface and area of each such wall, or there are (4) The signature of the USDA ac- ventilation openings located on all four credited veterinarian, assigned accredi- walls of the primary enclosure and the tation number, and date. ventilation openings on each such wall (d) Carriers and intermediate han- shall be at least 8 percent of the total dlers shall attempt to notify the con- surface area of each such wall: Pro- signee at least once in every 6 hour pe- vided, however, That at least one-third riod following the arrival of any live of the total minimum area required for guinea pig or hamster at the animal ventilation of the primary enclosure holding area of the terminal cargo fa- shall be located on the lower one-half cility. The time, date, and method of of the primary enclosure and at least each attempted notification and the one-third of the total minimum area final notification to the consignee and required for ventilation of the primary the name of the person notifying the enclosure shall be located on the upper consignee shall be recorded on the copy one-half of the primary enclosure; (6) of the shipping document retained by except as provided in paragraph (i) of the carrier or intermediate handler and this section, projecting rims or other on a copy of the shipping document ac- devices shall be on the exterior of the companying the animal shipment. outside walls with any ventilation [42 FR 31563, June 21, 1977, as amended at 43 openings to prevent obstruction of the FR 22163, May 16, 1978; 44 FR 63492, Nov. 2, ventilation openings and to provide a 1979] minimum air circulation space of 1.9 centimeters (.75 inches) between the § 3.36 Primary enclosures used to primary enclosure and any adjacent transport live guinea pigs and ham- cargo or conveyance wall; and (7) ex- sters. cept as provided in paragraph (i) of this No person subject to the Animal Wel- section, adequate handholds or other fare regulations shall offer for trans- devices for lifting shall be provided on portation, or transport, in commerce the exterior of the primary enclosure any live guinea pig or hamster in a pri- to enable the primary enclosure to be mary enclosure that does not conform lifted without tilting and to ensure to the following requirements: that the person handling the primary (a) Primary enclosures, such as com- enclosure will not be in contact with partments, transport cages, cartons, or the guinea pigs or hamsters. crates, used to transport live guinea (b) Live guinea pigs or hamsters pigs or hamsters shall be constructed tranported in the same primary enclo- in such a manner that (1) the struc- sure shall be of the same species and tural strength of the enclosure shall be maintained in compatible groups. sufficient to contain the live guinea (c) Primary enclosures used to trans- pigs or hamsters and to withstand the port live guinea pigs or hamsters shall normal rigors of transportation; (2) the be large enough to ensure that each interior of the enclosure shall be free animal contained therein has sufficient from any protrusions that could be in- space to turn about freely and to make jurious to the live guinea pigs or ham- normal postural adjustments. sters contained therein; (3) the inner (d) Not more than 15 live guinea pigs surfaces of corrugated fiberboard, card- shall be transported in the same pri- board, or plastic containers shall be mary enclosure. No more than 50 live covered or laminated with wire mesh hamsters shall be transported in the or screen where necessary to prevent same primary enclosure. escape of the animals; (4) the openings (e) In addition to the other provisions of such enclosures are easily accessible of this section, the following require- at all times for emergency removal of ments shall also apply to primary en- the live guinea pigs or hamsters; (5) ex- closures used to transport live guinea cept as provided in paragraph (i) of this pigs or hamsters: section, there are ventilation openings (1) Guinea pigs. (i) The interior height located on two opposite walls of the of primary enclosures used to tranport primary enclosure and the ventilation live guinea pigs weighing up to 500

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grams shall be at least 15.2 centimeters MINIMUM SPACE PER LIVE GUINEA PIG— (6 inches) and the interior height of Continued primary enclosures used to transport Square live guinea pigs weighing over 500 Weight (grams) centi- Square grams shall be at least 17.8 centimeters meters inches (7 inches). Over 600 ...... 354.8 55 (ii) Each live guinea pig transported in a primary enclosure shall be pro- (2) Hamsters. (i) The interior height of vided a minimum amount of floor primary enclosures used to transport space in accordance with the following live hamsters shall be at least 15.2 cen- table: timeters (6 inches) except that in the case of dwarf hamsters such interior MINIMUM SPACE PER LIVE GUINEA PIG height shall be at least 12.7 centimeters (5 inches). Square Square Weight (grams) centi- inches (ii) Each live hamster transported in meters a primary enclosure shall be provided a Up to 350 ...... 193.6 30 minimum amount of floor space in ac- 350 to 600 ...... 290.3 45 cordance with the following table:

MINIMUM SPACE PER LIVE HAMSTER

Dwarf Other Age Square Square centi- Square centi- Square meters inches meters inches

Weaning to 5 wks ...... 32.2 5.0 45.2 7 5 to 10 wks ...... 48.3 7.5 71.0 11 Over 10 wks ...... 58.1 9.0 96.8 15

(f) Primary enclosures used to trans- primary enclosure which is part of such port live guinea pigs or hamsters as shipment. provided in this section shall have solid (i) When a primary enclosure is per- bottoms to prevent leakage in ship- manently affixed within the animal ment and shall be cleaned and sanitized cargo space of the primary conveyance in a manner prescribed in § 3.31 of the so that the front opening is the only standards, if previously used. Such pri- source of ventilation for such primary mary enclosures shall contain clean enclosure, the front opening shall open litter of a suitable absorbent material, directly to the outside or to an unob- which is safe and nontoxic to the guin- structed aisle or passageway within the ea pigs or hamsters, in sufficient quan- primary conveyance. Such front ven- tity to absorb and cover excreta, unless tilation opening shall be at least 90 the guinea pigs or hamsters are on wire percent of the total surface area of the or other nonsolid floors. front wall of the primary enclosure and (g) Primary enclosures used to trans- covered with bars, wire mesh or port live guinea pigs or hamsters, ex- smooth expanded metal. cept where such primary enclosures are [42 FR 31563, June 21, 1977, as amended at 43 permanently affixed in the animal FR 21163, May 16, 1978; 55 FR 28882, July 16, cargo space of the primary conveyance, 1990] shall be clearly marked on top and on one or more sides with the words ‘‘Live § 3.37 Primary conveyances (motor ve- Animals’’ in letters not less than 2.5 hicle, rail, air, and marine). centimeters (1 inch) in height, and with (a) The animal cargo space of pri- arrows or other markings, to indicate mary conveyances used in transporting the correct upright position of the con- live guinea pigs and hamsters shall be tainer. designed and constructed to protect (h) Documents accompanying the the health, and ensure the safety and shipment shall be attached in an easily comfort of the live guinea pigs and accessible manner to the outside of a hamsters at all times.

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(b) The animal cargo space shall be § 3.38 Food and water requirements. constructed and maintained in a man- (a) If live guinea pigs or hamsters are ner to prevent the ingress of engine ex- to be transported for a period of more haust fumes and gases from the pri- than 6 hours, the animals shall have mary conveyance during transpor- access to food and water or a type of tation in commerce. food, which provides the requirements (c) No live guinea pig or hamster for food and water in quantity and shall be placed in an animal cargo quality sufficient to satisfy their food space that does not have a supply of air and water needs, during transit. sufficient for normal breathing for (b) Any dealer, research facility, ex- each live animal contained therein, hibitor or operator of an auction sale and the primary enclosures shall be po- offering any live guinea pig or hamster sitioned in the animal cargo space in to any carrier or intermediate handler such a manner that each live guinea for transportation, in commerce, shall pig or hamster has access to sufficient provide an adequate supply of food or air for normal breathing. type of food, which provides the re- (d) Primary enclosures shall be posi- quirements for food and water, within tioned in the primary conveyance in the primary enclosure to meet the re- such a manner that in an emergency quirements of this section. the live guinea pigs or hamsters can be (c) No carrier or intermediate han- removed from the primary conveyance dler shall accept for transportation, in as soon as possible. commerce, any live guinea pig or ham- (e) The interior of the animal cargo ster without an adequate supply of food space shall be kept clean. or type of food, which provides the re- (f) Live guinea pigs and hamsters quirements for food and water, within shall not be transported with any ma- the primary enclosure to meet the re- terial, substance (e.g., dry ice) or de- quirements of this section. vice which may reasonably be expected [42 FR 31563, June 21, 1977] to be injurious to the health and well- being of the guinea pigs and hamsters § 3.39 Care in transit. unless proper precaution is taken to (a) During surface transportation, it prevent such injury. shall be the responsibility of the driver (g) The animal cargo space of pri- or other employee to visually observe mary conveyances used to transport the live guinea pigs or hamsters as fre- guinea pigs or hamsters shall be me- quently as circumstances may dictate, chanically sound and provide fresh air but not less than once every 4 hours, to by means of windows, doors, vents, or assure that they are receiving suffi- air conditioning so as to minimize cient air for normal breathing, their drafts, odors, and moisture condensa- ambient temperatures are within the tion. Auxiliary ventilation, such as prescribed limits, all other applicable fans, blowers, or air conditioners, shall standards are being complied with and be used in any cargo space containing to determine whether any of the live live guinea pigs or hamsters when the guinea pigs or hamsters are in obvious ambient temperature in the animal physical distress and to provide any cargo space is 75 °F (23.9 °C) or higher. needed veterinary care as soon as pos- The ambient temperature within the sible. When transported by air, live animal cargo space shall not exceed 85 guinea pigs and hamsters shall be vis- °F (29.5 °C) or fall below 45 °F (7.2 °C), ually observed by the carrier as fre- except that the ambient temperature quently as circumstances may dictate, in the cargo space may be below 45 °F but not less than once every 4 hours, if the animal cargo space is accessible (7.2 °C) for hamsters if the hamsters are during flight. If the animal cargo space accompanied by a certificate of accli- is not accessible during flight, the car- mation to lower temperatures, as pro- rier shall visually observe the live vided in § 3.35(c) of this part. guinea pigs or hamsters whenever load- [42 FR 31563, June 21, 1977, as amended at 55 ed and unloaded and whenever the ani- FR 28882, July 16, 1990] mal cargo space is otherwise accessible

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to assure that they are receiving suffi- provisions of this paragraph, the air cient air for normal breathing, their temperature around any live guinea pig ambient temperatures are within the or hamster shall be measured and read prescribed limits, all other applicable outside the primary enclosure which standards are being complied with and contains such guinea pig or hamster at to determine whether any such live a distance not to exceed .91 meters (3 guinea pigs or hamsters are in obvious feet) from any one of the external walls physical distress. The carrier shall proof the primary enclosure and measured vide any needed veterinary care as on a level parallel to the bottom of soon as possible. No guinea pig or ham- such primary enclosure at a point ster in obvious physical distress shall which approximates half the distance be transported in commerce. between the top and bottom of such (b) During the course of transpor- primary enclosure. tation, in commerce, live guinea pigs or hamsters shall not be removed from [43 FR 56215, Dec. 1, 1978, as amended at 55 their primary enclosures unless placed FR 28883, July 16, 1990] in other primary enclosures or facilities conforming to the requirements § 3.41 Handling. provided in this subpart. (a) Any person who is subject to the Animal Welfare regulations and who [42 FR 31563, June 21, 1977] moves live guinea pigs or hamsters § 3.40 Terminal facilities. from an animal holding area of a terminal facility to a primary conveyance No person subject to the Animal Wel- or vice versa shall do so as quickly and fare regulations shall commingle ship- efficiently as possible. Any person sub- ments of live guinea pigs or hamsters ject to the Animal Welfare Act and with inanimate cargo. All animal hold- holding any live guinea pig or hamster ing areas of a terminal facility where in an animal holding area of a terminal shipments of live guinea pigs or ham- facility or transporting any live guinea sters are maintained shall be cleaned pig or hamster to or from a terminal and sanitized as prescribed in § 3.31 of facility shall provide the following: the standards often enough to prevent an accumulation of debris or excreta, (1) Shelter from sunlight. When sun- to minimize vermin infestation, and to light is likely to cause overheating or prevent a disease hazard. An effective discomfort, sufficient shade shall be program for the control of insects, provided to protect the live guinea pigs ectoparasites, and avian and mamma- and hamsters from the direct rays of lian pests shall be established and the sun and such live guinea pigs or maintained for all animal holding hamsters shall not be subjected to sur- areas. Any animal holding area con- rounding air temperatures which ex- taining live guinea pigs or hamsters ceed 29.5 °C. (85 °F.), and which shall be shall be provided with fresh air by measured and read in the manner pre- means of windows, doors, vents, or air scribed § 3.40 of this part, for a period of conditioning and may be ventilated or more than 45 minutes. air circulated by means of fans, blow- (2) Shelter from rain or snow. Live ers, or an air conditioning system so as guinea pigs and hamsters shall be pro- to minimize drafts, odors, and moisture vided protection to allow them to re- condensation. Auxiliary ventilation, main dry during rain or snow. such as exhaust fans and vents or fans (3) Shelter from cold weather. Trans- or blowers or air conditioning shall be porting devices shall be covered to pro- used for any animal holding area con- vide protection for live guinea pigs and taining live guinea pigs and hamsters hamsters when the outdoor air tem- when the air temperature within such perature falls below 10 °C. (50 °F.), and animal holding area is 23.9 °C. (75. °F.) such live guinea pigs and hamsters or higher. The air temperature around shall not be subjected to surrounding any live guinea pig or hamster in any air temperatures which fall below 7.2 animal holding area shall not be al- °C. (45 °F.), and which shall be meas- lowed to fall below 7.2 °C. (45 °F.) nor be ured and read in the manner prescribed allowed to exceed 29.5 °C. (85 °F.) at any in § 3.40 of this part, for a period of time. To ascertain compliance with the more than 45 minutes.

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(b) Care shall be exercised to avoid (b) Ventilation. Indoor housing facili- handling of the primary enclosure in ties for rabbits shall be adequately ven- such a manner that may cause physical tilated to provide for the health and or emotional trauma to the live guinea comfort of the animals at all times. pig or hamster contained therein. Such facilities shall be provided with (c) Primary enclosures used to trans- fresh air either by means of windows, port any live guinea pig or hamster doors, vents, or air conditioning and shall not be tossed, dropped, or need- shall be ventilated so as to minimize lessly tilted and shall not be stacked in drafts, odors, and moisture condensa- a manner which may reasonably be ex- tion. Auxiliary ventilation, such as expected to result in their falling. haust fans and vents or air condi- [43 FR 21163, May 16, 1978, as amended at 43 tioning, shall be provided when the am- FR 56216, Dec. 1, 1978; 55 FR 28883, July 16, bient temperature is 85 °F. or higher. 1990] (c) Lighting. Indoor housing facilities for rabbits shall have ample light, by Subpart C—Specifications for the natural or artificial means, or both, of Humane Handling, Care, good quality and well distributed. Such Treatment and Transportation lighting shall provide uniformly dis- of Rabbits tributed illumination of sufficient light intensity to permit routine in- FACILITIES AND OPERATING STANDARDS spection and cleaning during the entire § 3.50 Facilities, general. working period. Primary enclosures shall be so placed as to protect the rab- (a) Structural strength. Indoor and bits from excessive illumination. outdoor housing facilities for rabbits (d) The interior shall be structurally sound and shall be Interior surfaces. maintained in good repair, to protect building surfaces of indoor housing fa- the animals from injury, to contain the cilities shall be constructed and main- animals, and to restrict the entrance of tained so that they are substantially other animals. impervious to moisture and may be (b) Water and electric power. Reliable readily sanitized. and adequate electric power, if required to comply with other provisions § 3.52 Facilities, outdoor. of this subpart, and adequate potable (a) Shelter from sunlight. When sun- water shall be available. light is likely to cause overheating or (c) Storage. Supplies of food and bed- discomfort, sufficient shade shall be ding shall be stored in facilities which provided to allow all rabbits kept out- adequately protect such supplies doors to protect themselves from the against infestation or contamination direct rays of the sun. When the atmos- by vermin. Refrigeration shall be pro- pheric temperature exceeds 90 °F. arti- vided for supplies of perishable food. ficial cooling shall be provided by a (d) Waste disposal. Provision shall be sprinkler system or other means. made for the removal and disposal of (b) Shelter from rain or snow. Rabbits animal and food wastes, bedding, dead animals, and debris. Disposal facilities kept outdoors shall be provided with shall be so provided and operated as to access to shelter to allow them to re- minimize vermin infestation, odors, main dry during rain or snow. and disease hazards. (c) Shelter from cold weather. Shelter (e) Washroom and sinks. Facilities, shall be provided for all rabbits kept such as washrooms, basins, or sinks, outdoors when the atmospheric tem- shall be provided to maintain cleanli- perature falls below 40 °F. ness among animal caretakers. (d) Protection from predators. Outdoor [32 FR 3273, Feb. 24, 1967, as amended at 44 housing facilities for rabbits shall be FR 63492, Nov. 2, 1979] fenced or otherwise enclosed to minimize the entrance of predators. § 3.51 Facilities, indoor. (e) Drainage. A suitable method shall (a) Heating. Indoor housing facilities be provided to rapidly eliminate excess for rabbits need not be heated. water.

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§ 3.53 Primary enclosures. with adequate freedom of movement. All primary enclosures for rabbits Each rabbit housed in a primary enclo- shall conform to the following require- sure shall be provided a minimum ments: amount of floor space, exclusive of the space taken up by food and water re- (a) General. (1) Primary enclosures shall be structurally sound and main- ceptacles, in accordance with the fol- tained in good repair to protect the lowing table: rabbits from injury, to contain them, Minimum and to keep predators out. space per Category Individual weights rabbit (2) Primary enclosures shall be con- (pounds) (square structed and maintained so as to en- inches) able the rabbits to remain dry and Groups ...... 3 through 5 ...... 144 clean. 6 through 8 ...... 288 (3) Primary enclosures shall be con- 9 or more ...... 432 structed and maintained so that the Individual adults ...... 3 through 5 ...... 180 6 through 8 ...... 360 rabbits contained therein have conven- 9 through 11 ...... 540 ient access to clean food and water as 12 or more ...... 720 required in this subpart. Nursing females ...... 3 through 5 ...... 576 6 through 8 ...... 720 (4) The floors of the primary enclo- 9 through 11 ...... 864 sures shall be constructed so as to pro- 12 or more ...... 1080 tect the rabbits’ feet and legs from injury. Litter shall be provided in all pri- (c) Space requirements for primary en- mary enclosures having solid floors. closures acquired on or after August 15, (5) A suitable nest box containing 1990. (1) Primary enclosures shall be clean nesting material shall be pro- constructed and maintained so as to vided in each primary enclosure hous- provide sufficient space for the animal ing a female with a litter less than one to make normal postural adjustments month of age. with adequate freedom of movement. (b) Space requirements for primary en- (2) Each rabbit housed in a primary closures acquired before August 15, 1990. enclosure shall be provided a minimum Primary enclosures shall be con- amount of floor space, exclusive of the structed and maintained so as to pro- space taken up by food and water re- vide sufficient space for the animal to ceptacles, in accordance with the fol- make normal postural adjustments lowing table:

Individual weights Minimum floor space Minimum interior height

kg lbs m2 ft2 cm in

Individual rabbits (weaned) ...... <2 <4.4 0.14 1.5 35.56 14 2–4 4.4–8.8 0.28 3.0 35.56 14 4–5.4 8.8–11.9 0.37 4.0 35.56 14 >5.4 >11.9 0.46 5.0 35.56 14

Weight of nursing female Minimum floor space/fe- Minimum interior height male & litter kg lbs cm in m2 ft2

Females with litters ...... <2 <4.4 0.37 4.0 35.56 14 2–4 4.4–8.8 0.46 5.0 35.56 14 4–5.4 8.8–11.9 0.56 6.0 35.56 14 >5.4 >11.9 0.70 7.5 35.56 14

(3) Innovative primary enclosures facilities when approved by the Institu- that do not precisely meet the space tional Animal Care and Use Com- requirements of paragraph (c)(2) of this mittee, and by dealers and exhibitors section, but that do provide rabbits when approved by the Administrator. with a sufficient volume of space and [32 FR 3273, Feb. 24, 1967, as amended at 55 the opportunity to express species-typ- FR 28883, July 16, 1990] ical behavior, may be used at research

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ANIMAL HEALTH AND HUSBANDRY previously occupied, such enclosures STANDARDS shall be sanitized in the manner provided in paragraph (b)(3) of this sec- § 3.54 Feeding. tion. (a) Rabbits shall be fed at least once (3) Primary enclosures for rabbits each day except as otherwise might be shall be sanitized by washing them required to provide adequate veteri- with hot water (180 °F.) and soap or de- nary care. The food shall be free from tergent as in a mechanical cage wash- contamination, wholesome, palatable er, or by washing all soiled surfaces and of sufficient quantity and nutritive with a detergent solution followed by a value to meet the normal daily re- safe and effective disinfectant, or by quirements for the condition and size cleaning all soiled surfaces with live of the rabbit. steam or flame. (b) Food receptacles shall be acces- (c) Housekeeping. Premises (buildings sible to all rabbits in a primary enclo- and grounds) shall be kept clean and in sure and shall be located so as to mini- good repair in order to protect the ani- mize contamination by excreta. All mals from injury and to facilitate the food receptacles shall be kept clean prescribed husbandry practices set and sanitized at least once every 2 forth in this subpart. Premises shall re- weeks. If self feeders are used for the main free of accumulations of trash. feeding of dry feed, measures must be (d) Pest control. An effective program taken to prevent molding, deteriora- for the control of insects, tion or caking of the feed. ectoparasites, and avian and mammalian pests shall be established and § 3.55 Watering. maintained. Sufficient potable water shall be provided daily except as might otherwise § 3.57 Employees. be required to provide adequate veteri- A sufficient number of employees nary care. All watering receptacles shall be utilized to maintain the pre- shall be sanitized when dirty: Provided, scribed level of husbandry practices set however, That such receptacles shall be forth in this subpart. Such practices sanitized at least once every 2 weeks. shall be under the supervision of an animal caretaker who has a back- § 3.56 Sanitation. ground in animal husbandry or care. (a) Cleaning of primary enclosures. (1) Primary enclosures shall be kept rea- § 3.58 Classification and separation. sonably free of excreta, hair, cobwebs Animals housed in the same primary and other debris by periodic cleaning. enclosure shall be maintained in com- Measures shall be taken to prevent the patible groups, with the following addi- wetting of rabbits in such enclosures if tional restrictions: a washing process is used. (a) Rabbits shall not be housed in the (2) In primary enclosures equipped same primary enclosure with any other with solid floors, soiled litter shall be species of animals unless required for removed and replaced with clean litter scientific reasons. at least once each week. (3) If primary enclosures are equipped (b) Rabbits under quarantine or with wire or mesh floors, the troughs treatment for a communicable disease or pans under such enclosures shall be shall be separated from other rabbits cleaned at least once each week. If and other susceptible species of ani- worm bins are used under such enclo- mals in such a manner as to minimize sures they shall be maintained in a dissemination of such disease. sanitary condition. § 3.59 [Reserved] (b) Sanitization of primary enclosures. (1) Primary enclosures for rabbits shall TRANSPORTATION STANDARDS be sanitized at least once every 30 days in the manner provided in paragraph AUTHORITY: Sections 3.60 through 3.66 (b)(3) of this section. issued under secs. 3, 5, 6, 10, 11, 14, 16, 17, 21; (2) Prior to the introduction of rab- 80 Stat. 353; 84 Stat. 1561, 1562, 1563, 1564; 90 bits into empty primary enclosures Stat. 418, 420, 423 (7 U.S.C. 2133, 2135, 2136,

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2140, 2141, 2144, 2146, 2147, 2151); 37 FR 28464, certificate shall include at least the 28477, 38 FR 19141. following information: SOURCE: Sections 3.60 through 3.66 appear (1) Name and address of the con- at 42 FR 31565, June 21, 1977, unless otherwise signor; noted. (2) The number of rabbits in the primary enclosure(s); § 3.60 Consignments to carriers and in- (3) A certifying statement (e.g., ‘‘I termediate handlers. hereby certify that the ll (number) (a) Carriers and intermediate han- primary enclosure(s) which are used to dlers shall not accept any live rabbit transport the animal(s) in this ship- presented by any dealer, research facil- ment complies (comply) with USDA ity, exhibitor, operator of an auction standards for primary enclosures (9 sale, or other person, or any depart- CFR part 3).’’); and ment, agency, or instrumentality of (4) The signature of the consignor, the United States or any State or local and date. government for shipment, in com- (c) Carriers or intermediate handlers merce, more than 4 hours prior to the whose facilities fail to meet the min- scheduled departure of the primary imum temperature allowed by the conveyance on which it is to be trans- standards may accept for transpor- ported: Provided, however, That the car- tation or transport, in commerce, any rier or intermediate handler and any live rabbit consigned by any depart- dealer, research facility, exhibitor, opment, agency, or instrumentality of erator of an auction sale, or other per- the United States or of any State or son, or any department, agency, or in- local government, or by any person (instrumentality of the United States or cluding any licensee or registrant any State or local government may under the Act, as well as any private mutually agree to extend the time of individual) if the consignor furnishes acceptance to not more than 6 hours if to the carrier or intermediate handler specific prior scheduling of the animal a certificate executed by a veterinarian shipment to destination has been accredited by this Department pursu- made. ant to part 160 of this title on a speci- (b) Any carrier or intermediate han- fied date which shall not be more than dler shall only accept for transpor- 10 days prior to delivery of such rabbit tation or transport, in commerce, any for transportation in commerce, stat- live rabbit in a primary enclosure ing that such live rabbit is acclimated which conforms to the requirements to air temperatures lower than those set forth in § 3.61 of the standards: Pro- prescribed in §§ 3.65 and 3.66. A copy of vided, however, That any carrier or in- such certificate shall accompany the termediate handler may accept for shipment to destination. The certifi- transportation or transport, in com- cate shall include at least the fol- merce, any live rabbit consigned by lowing information: any department, agency, or instrumen- (1) Name and address of the con- tality of the United States having lab- signor; oratory animal facilities or exhibiting (2) The number of rabbits in the ship- animals or any licensed or registered ment; dealer, research facility, exhibitor, or (3) A certifying statement (e.g., ‘‘I operator of any auction sale, if such hereby certify that the animal(s) in consignor furnishes to the carrier or this shipment is (are), to the best of intermediate handler a certificate, my knowledge, acclimated to air tem- signed by the consignor, stating that peratures lower than 7.2 °C. (45 °F.).)’’; the primary enclosure complies with and § 3.61 of the standards, unless such pri- (4) The signature of the USDA ac- mary enclosure is obviously defective credited veterinarian, assigned accredi- or damaged and it is apparent that it tation number, and date. cannot reasonably be expected to con- (d) Carriers and intermediate han- tain the live rabbit without causing dlers shall attempt to notify the con- suffering or injury to such live rabbit. signee at least once in every 6 hour pe- A copy of such certificate shall accom- riod following the arrival of any live pany the shipment to destination. The rabbit at the animal holding area of

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the terminal cargo facility. The time, on the upper one-half of the primary date, and method of each attempted enclosure; notification and the final notification (5) Except as provided in paragraph to the consignee and the name of the (h) of this section, projecting rims or person notifying the consignee shall be other devices shall be on the exterior of recorded on the copy of the shipping the outside walls with any ventilation document retained by the carrier or in- openings to prevent obstruction of the termediate handler and on a copy of ventilation openings and to provide a the shipping document accompanying minimum air circulation space 1.9 cen- the animal shipment. timeters (.75 inch) between the primary enclosure and any adjacent cargo or [42 FR 31565, June 21, 1977, as amended at 43 conveyance wall; and FR 21164, May 16, 1978; 44 FR 63493, Nov. 2, 1979] (6) Except as provided in paragraph (h) of this section, adequate handholds § 3.61 Primary enclosures used to or other devices for lifting shall be pro- transport live rabbits. vided on the exterior of the primary enclosure to enable the primary enclo- No person subject to the Animal Wel- sure to be lifted without tilting and to fare regulations shall offer for trans- ensure that the person handling the portation or transport in commerce primary enclosure will not be in con- any live rabbit in a primary enclosure tact with the rabbit. that does not conform to the following (b) Live rabbits transported in the requirements: same primary enclosure shall be main- (a) Primary enclosures, such as com- tained in compatible groups and shall partments, transport cages, cartons, or not be transported in the same primary crates, used to transport live rabbits enclosure with other specie of animals. shall be constructed in such a manner (c) Primary enclosures used to trans- that: port live rabbits shall be large enough (1) The stuctural strength of the en- to ensure that each rabbit contained closure shall be sufficient to contain therein has sufficient space to turn the live rabbits and to withstand the about freely and to make normal pos- normal rigors of transportation; tural adjustments. (2) The interior of the enclosure shall (d) Not more than 15 live rabbits be free from any protrusions that could shall be transported in the same pri- be injurious to the live rabbits con- mary enclosure. tained therein; (e) Primary enclosures used to trans- (3) The openings of such enclosures port live rabbits as provided in this are easily accessible at all times for section shall have solid bottoms to pre- emergency removal of the live rabbits; vent leakage in shipment and shall be (4) Except as provided in paragraph cleaned and sanitized in a manner pre- (h) of this section, there are ventila- scribed in § 3.56 of the standards, if pre- tion openings located on two opposite viously used. Such primary enclosures walls of the primary enclosure and the shall contain clean litter of a suitable ventilation openings on each such wall absorbent material which is safe and shall be at least 16 percent of the total nontoxic to the rabbits, in sufficient surface area of each such wall, or there quantity to absorb and cover excreta, are ventilation openings located on all unless the rabbits are on wire or other four walls of the primary enclosure and nonsolid floors. the ventilation openings on each such (f) Primary enclosures used to trans- wall shall be at least 8 percent of the port live rabbits, except where such total surface area of each such wall: primary enclosures are permanently af- Provided, however, That at least one- fixed in the animal cargo space of the third of the total minimum area re- primary conveyance, shall be clearly quired for ventilation of the primary marked on top and on one or more enclosure shall be located on the lower sides with the works ‘‘Live Animal’’ in one-half of the primary enclosure and letters not less than 2.5 centimeters (1 at least one-third of the total min- inch) in height, and with arrows or imum area required for ventilation of other markings, to indicate the correct the primary enclosure shall be located upright position of the container.

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(g) Documents accompanying the unless proper precaution is taken to shipment shall be attached in an easily prevent such injury. accessible manner to the outside of a (g) The animal cargo space of pri- primary enclosure which is part of such mary conveyances used to transport shipment. rabbits shall be mechanically sound (h) When a primary enclosure is per- and provide fresh air by means of win- manently affixed within the animal dows, doors, vents, or air conditioning cargo space of the primary conveyance so as to minimize drafts, odors, and so that the front opening is the only moisture condensation. Auxiliary ven- source of ventilation for such primary tilation, such as fans, blowers, or air enclosure, the front opening shall open conditioners, shall be used in any cargo directly to the outside or to an unob- space containing live rabbits when the structed aisle or passageway within the ambient temperature in the animal primary conveyance. Such front ven- cargo space is 75 °F (23.9 °C) or higher. tilation opening shall be at least 90 The ambient temperature within the percent of the total surface area of the animal cargo space shall not exceed 85 front wall of the primary enclosure and °F (29.5 °C) or fall below 45 °F (7.2 °C), covered with bars, wire mesh or except that the ambient temperature smooth expanded metal. in the cargo space may be below 45 °F ° [42 FR 31565, June 21, 1977, as amended at 43 (7.2 C) if the rabbits are accompanied FR 21164, May 16, 1978; 55 FR 28883, July 16, by a certificate of acclimation to lower 1990] temperatures, as provided in § 3.60(c) of this part. § 3.62 Primary conveyances (motor vehicle, rail, air, and marine). [42 FR 31565, June 21, 1977, as amended at 55 FR 28883, July 16, 1990] (a) The animal cargo space of primary conveyances used in transporting § 3.63 Food and water requirements. live rabbits shall be designed and con- (a) If live rabbits are to be trans- structed to protect the health, and en- ported for a period of more than 6 sure the safety and comfort of the rab- hours, they shall have access to food bits contained therein at all times. (b) The animal cargo space shall be and water or a type of food, which pro- constructed and maintained in a man- vides the requirements for food and ner to prevent the ingress of engine ex- water in quantity and quality suffi- haust fumes and gases from the pri- cient to satisfy their food and water mary conveyance during transpor- needs, during transit. tation in commerce. (b) Any dealer, research facility, ex- (c) No live rabbit shall be placed in hibitor or operator of an auction sale an animal cargo space that does not offering any live rabbit to any carrier have a supply of air sufficient for nor- or intermediate handler for transpor- mal breathing for each live animal con- tation, in commerce, shall provide an tained therein, and the primary enclo- adequate supply of food or type of food, sures shall be positioned in the animal which provides the requirements for cargo space in such a manner that each food and water, within the primary en- rabbit has access to sufficient air for closure to meet the requirements of normal breathing. this section. (d) Primary enclosures shall be posi- (c) No carrier or intermediate han- tioned in the primary conveyance in dler shall accept for transportation, in such a manner that in an emergency commerce, any live rabbit without an the live rabbits can be removed from adequate supply of food or type of food, the primary conveyance as soon as pos- which provides the requirements for sible. food and water, within the primary en- (e) The interior of the animal cargo closure to meet the requirements of space shall be kept clean. this section. (f) Live rabbits shall not be transported with any material, substance § 3.64 Care in transit. (e.g., dry ice) or device which may rea- (a) During surface transportation, it sonably be expected to be injurious to shall be the responsibility of the driver the health and well-being of the rabbits or other employee to visually observe

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the live rabbits as frequently as cir- with fresh air by means of windows, cumstances may dictate, but not less doors, vents, or air conditioning and than once every 4 hours, to assure that may be ventilated or air circulated by they are receiving sufficient air for means of fans, blowers, or an air condi- normal breathing, their ambient tem- tioning system so as to minimize peratures are within the prescribed drafts, odors, and moisture condensa- limits, all other applicable standards tion. Auxiliary ventilation, such as ex- are being complied with and to deter- haust fans and vents or fans or blowers mine whether any of the live rabbits or air conditioning shall be used for are in obvious physical disress and to any animal holding area containing provide any needed veterinary care as live rabbits when the air temperature soon as possible. When transported by within such animal holding area is 23.9 air, live rabbits shall be visually ob- °C. (75 °F.) or higher. The air tempera- served by the carrier as frequently as ture around any live rabbit in any ani- circumstances may dictate, but not mal holding area shall not be allowed less than once every 4 hours, if the to fall below 7.2 °C. (45 °F.) nor be al- cargo space is accessible during flight. lowed to exceed 29.5 °C. (85 °F.) at any If the animal cargo space is not acces- time. To ascertain compliance with the sible during flight, the carrier shall provisions of this paragraph, the air visually observe the live rabbits when- temperature around any live rabbit ever loaded and unloaded and whenever shall be measured and read outside the the animal cargo space is otherwise ac- primary enclosure which contains such cessible to assure that they are receiv- rabbit at a distance not to exceed .91 ing sufficient air for normal breathing, meters (3 feet) from any one of the ex- their ambient temperatures are within ternal walls of the primary enclosure the prescribed limits, all other applica- and on a level parallel to the bottom of ble standards are being complied with such primary enclosure at a point and to determine whether any such live which approximates half the distance rabbits are in obvious physical distress. between the top and bottom of such The carrier shall provide any needed primary enclosure. veterinary care as soon as possible. No [43 FR 56216, Dec. 1, 1978, as amended at 55 rabbit in obvious physical distress FR 28883, July 16, 1990]] shall be transported in commerce. (b) During the course of transpor- § 3.66 Handling. tation, in commerce, live rabbits shall (a) Any person who is subject to the not be removed from their primary en- Animal Welfare regulations and who closures unless placed in other primary moves live rabbits from an animal enclosures or facilities conforming to holding area of a terminal facility to a the requirements provided in this sub- primary conveyance or vice versa shall part. do so as quickly and efficiently as possible. Any person subject to the Animal § 3.65 Terminal facilities. Welfare regulations and holding any No person subject to the Animal Wel- live rabbit in an animal holding area of fare regulations shall commingle ship- a terminal facility or transporting any ments of live rabbits with inanimate live rabbit to or from a terminal facil- cargo. All animal holding areas of a ity shall provide the following: terminal facility where shipments of (1) Shelter from sunlight. When sun- rabbits are maintained shall be cleaned light is likely to cause overheating or and sanitized as prescribed in § 3.56 of discomfort, sufficient shade shall be the standards often enough to prevent provided to protect the live rabbits an accumulation of debris or excreta, from the direct rays of the sun and to minimize vermin infestation, and to such live rabbits shall not be subjected prevent a disease hazard. An effective to surrounding air temperatures which program for the control of insects, exceed 29.5 °C. (85 °F.), and which shall ectoparasites, and avian and mamma- be measured and read in the manner lian pests shall be established and prescribed in § 3.65 of this part, for a pe- maintained for all animal holding riod of more than 45 minutes. areas. Any animal holding area con- (2) Shelter from rain or snow. Live rab- taining live rabbits shall be provided bits shall be provided protection to

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allow them to remain dry during rain be designed and constructed so that or snow. they are structurally sound for the spe- (3) Shelter from cold weather. Trans- cies of nonhuman primates housed in porting devices shall be covered to pro- them. They must be kept in good re- vide protection for live rabbits when pair, and they must protect the ani- the outdoor air temperature falls below mals from injury, contain the animals 10 °C. (50 °F.), and such live rabbits securely, and restrict other animals shall not be subjected to surrounding from entering. air temperatures which fall below 7.2 (b) Condition and site. Housing facili- °C. (45 °F.), and which shall be meas- ties and areas used for storing animal ured and read in the manner prescribed food or bedding must be free of any ac- in § 3.65 of this part, for a period of cumulation of trash, waste material, more than 45 minutes unless such rab- junk, weeds, and other discarded mate- bits are accompanied by a certificate of rials. Animal areas inside of housing acclimation to lower temperatures as facilities must be kept neat and free of prescribed in § 3.60(c). clutter, including equipment, fur- (b) Care shall be exercised to avoid niture, or stored material, but may handling of the primary enclosure in contain materials actually used and such a manner that may cause physical necessary for cleaning the area, and or emotional trauma to the live rabbit fixtures and equipment necessary for contained therein. proper husbandry practices and re- (c) Primary enclosures used to trans- search needs. Housing facilities other port any live rabbit shall not be tossed, than those maintained by research fa- dropped, or needlessly tilted and shall cilities and Federal research facilities not be stacked in a manner which may must be physically separated from any reasonably be expected to result in other businesses. If a housing facility their falling. is located on the same premises as any other businesses, it must be physically [43 FR 21164, May 16, 1978, as amended at 43 FR 56216, Dec. 1, 1978; 55 FR 28883, July 16, separated from the other businesses so 1990] that animals the size of dogs, skunks, and raccoons, are prevented from en- Subpart D—Specifications for the tering it. (c) Surfaces—(1) General requirements. Humane Handling, Care, The surfaces of housing facilities—in- Treatment, and Transportation cluding perches, shelves, swings, boxes, of Nonhuman Primates 2 houses, dens, and other furniture-type fixtures or objects within the facility— SOURCE: 56 FR 6495, Feb. 15, 1991, unless must be constructed in a manner and otherwise noted. made of materials that allow them to be readily cleaned and sanitized, or re- FACILITIES AND OPERATING STANDARDS moved or replaced when worn or soiled. Furniture-type fixtures or objects must § 3.75 Housing facilities, general. be sturdily constructed and must be (a) Structure: construction. Housing strong enough to provide for the safe facilities for nonhuman primates must activity and welfare of nonhuman primates. Floors may be made of dirt, ab- 2 Nonhuman primates include a great diver- sorbent bedding, sand, gravel, grass, or sity of forms, ranging from the marmoset other similar material that can be weighing only a few ounces, to the adult go- readily cleaned, or can be removed or rilla weighing hundreds of pounds, and include more than 240 species. They come from replaced whenever cleaning does not Asia, Africa, and Central and South Amer- ica, and they live in different habitats in na- these minimum specifications must be ap- ture. Some have been transported to the plied in accordance with the customary and United States from their natural habitats generally accepted professional and hus- and some have been raised in captivity in the bandry practices considered appropriate for United States. Their nutritional and activity each species, and necessary to promote their requirements differ, as do their social and psychological well-being. environmental requirements. As a result, the These minimum standards apply only to conditions appropriate for one species do not live nonhuman primates, unless stated oth- necessarily apply to another. Accordingly, erwise.

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eliminate odors, diseases, pests, in- cleaning and for carrying out other sects, or vermin. Any surfaces that husbandry requirements. come in contact with nonhuman pri- (e) Storage. Supplies of food and bed- mates must: ding must be stored in a manner that (i) Be free of excessive rust that pre- protects the supplies from spoilage, vents the required cleaning and saniti- contamination, and vermin infestation. zation, or that affects the structural The supplies must be stored off the strength of the surface; and floor and away from the walls, to allow (ii) Be free of jagged edges or sharp cleaning underneath and around the points that might injure the animals. supplies. Food requiring refrigeration (2) Maintenance and replacement of must be stored accordingly, and all surfaces. All surfaces must be main- food must be stored in a manner that tained on a regular basis. Surfaces of prevents contamination and deteriora- housing facilities—including houses, tion of its nutritive value. Only the dens, and other furniture-type fixtures food and bedding currently being used and objects within the facility—that may be kept in animal areas, and when cannot be readily cleaned and sani- not in actual use, open food and bed- tized, must be replaced when worn or ding supplies must be kept in leakproof soiled. containers with tightly fitting lids to (3) Cleaning. Hard surfaces with prevent spoilage and contamination. which nonhuman primates come in Substances that are toxic to the contact must be spot-cleaned daily and nonhuman primates but that are re- sanitized in accordance with § 3.84 of quired for normal husbandry practices this subpart to prevent accumulation must not be stored in food storage and of excreta or disease hazards. If the preparation areas, but may be stored in species scent mark, the surfaces must cabinets in the animal areas. be sanitized or replaced at regular in- (f) Drainage and waste disposal. Hous- tervals as determined by the attending ing facility operators must provide for veterinarian in accordance with gen- regular and frequent collection, re- erally accepted professional and hus- moval, and disposal of animal and food bandry practices. Floors made of dirt, wastes, bedding, dead animals, debris, absorbent bedding, sand, gravel, grass, garbage, water, and any other fluids or other similar material, and planted and wastes, in a manner that mini- enclosures must be raked or spot- mizes contamination and disease risk. cleaned with sufficient frequency to Housing facilities must be equipped ensure all animals the freedom to with disposal facilities and drainage avoid contact with excreta. Contami- systems that are constructed and oper- nated material must be removed or re- ated so that animal wastes and water placed whenever raking and spot clean- are rapidly eliminated and the animals ing does not eliminate odors, diseases, stay dry. Disposal and drainage sys- insects, pests, or vermin infestation. tems must minimize vermin and pest All other surfaces of housing facilities infestation, insects, odors, and disease must be cleaned and sanitized when hazards. All drains must be properly necessary to satisfy generally accepted constructed, installed, and maintained. husbandry standards and practices. If closed drainage systems are used, Sanitization may be done by any of the they must be equipped with traps and methods provided in § 3.84(b)(3) of this prevent the backflow of gases and the subpart for primary enclosures. backup of sewage onto the floor. If the (d) Water and electric power. The hous- facility uses sump ponds, settlement ing facility must have reliable electric ponds, or other similar systems for power adequate for heating, cooling, drainage and animal waste disposal, ventilation, and lighting, and for car- the system must be located far enough rying out other husbandry require- away from the animal area of the hous- ments in accordance with the regula- ing facility to prevent odors, diseases, tions in this subpart. The housing fa- insects, pests, and vermin infestation. cility must provide running potable If drip or constant flow watering de- water for the nonhuman primates’ vices are used to provide water to the drinking needs. It must be adequate for animals, excess water must be rapidly

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drained out of the animal areas by gut- generally accepted professional and ters or pipes so that the animals stay husbandry practices. dry. Standing puddles of water in ani- (c) Lighting. Indoor housing facilities mal areas must be mopped up or must be lighted well enough to permit drained so that the animals remain routine inspection and cleaning of the dry. Trash containers in housing facili- facility, and observation of the ties and in food storage and food prepa- nonhuman primates. Animal areas ration areas must be leakproof and must be provided a regular diurnal must have tightly fitted lids on them lighting cycle of either natural or arti- at all times. Dead animals, animal ficial light. Lighting must be uni- parts, and animal waste must not be formly diffused throughout animal fa- kept in food storage or food prepara- cilities and provide sufficient illumination areas, food freezers, food refrig- tion to aid in maintaining good house- erators, and animal areas. keeping practices, adequate cleaning, (g) Washrooms and sinks. Washing fa- adequate inspection of animals, and for cilities, such as washrooms, basins, the well-being of the animals. Primary sinks, or showers must be provided for enclosures must be placed in the hous- animal caretakers and must be readily ing facility so as to protect the accessible. nonhuman primates from excessive light. § 3.76 Indoor housing facilities. § 3.77 Sheltered housing facilities. (a) Heating, cooling, and temperature. (a) Heating, cooling, and temperature. Indoor housing facilities must be suffi- The sheltered part of sheltered housing ciently heated and cooled when nec- facilities must be sufficiently heated essary to protect nonhuman primates and cooled when necessary to protect from temperature extremes and to pro- the nonhuman primates from tempera- vide for their health and well-being. ture extremes, and to provide for their The ambient temperature in the facil- health and well-being. The ambient ° ° ity must not fall below 45 F (7.2 C) for temperature in the sheltered part of more than 4 consecutive hours when the facility must not fall below 45 °F nonhuman primates are present, and (7.2 °C) for more than 4 consecutive ° ° must not rise above 85 F (29.5 C) for hours when nonhuman primates are more than 4 consecutive hours when present, and must not rise above 85 °F nonhuman primates are present. The (29.5 °C) for more than 4 consecutive ambient temperature must be main- hours when nonhuman primates are tained at a level that ensures the present, unless temperatures above 85 health and well-being of the species °F (29.5 °C) are approved by the attend- housed, as directed by the attending ing veterinarian, in accordance with veterinarian, in accordance with gen- generally accepted husbandry prac- erally accepted professional and hus- tices. The ambient temperature must bandry practices. be maintained at a level that ensures (b) Ventilation. Indoor housing facili- the health and well-being of the species ties must be sufficiently ventilated at housed, as directed by the attending all times when nonhuman primates are veterinarian, in accordance with gen- present to provide for their health and erally accepted professional and hus- well-being and to minimize odors, bandry practices. drafts, ammonia levels, and moisture (b) Ventilation. The sheltered part of condensation. Ventilation must be pro- sheltered animal facilities must be suf- vided by windows, doors, vents, fans, or ficiently ventilated at all times to pro- air conditioning. Auxiliary ventilation, vide for the health and well-being of such as fans, blowers, or air condi- nonhuman primates and to minimize tioning, must be provided when the odors, drafts, ammonia levels, and ambient temperature is 85 °F (29.5 °C) moisture condensation. Ventilation or higher. The relative humidity main- must be provided by windows, doors, tained must be at a level that ensures vents, fans, or air conditioning. Auxil- the health and well-being of the ani- iary ventilation, such as fans, blowers, mals housed, as directed by the attend- or air conditioning, must be provided ing veterinarian, in accordance with when the ambient temperature is 85 °F

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(29.5 °C) or higher. The relative humid- ficient distance from the outside wall ity maintained must be at a level that or fence of the primary enclosure to ensures the health and well-being of prevent physical contact between ani- the species housed, as directed by the mals inside the enclosure and outside attending veterinarian, in accordance the perimeter fence. Such fences less with generally accepted professional than 3 feet in distance from the pri- and husbandry practices. mary enclosure must be approved by (c) Lighting. The sheltered part of the Administrator. A perimeter fence sheltered housing facilities must be is not required if: lighted well enough to permit routine (1) The outside walls of the primary inspection and cleaning of the facility, enclosure are made of a sturdy, durable and observation of the nonhuman pri- material such as concrete, wood, plas- mates. Animal areas must be provided tic, metal, or glass, and are high a regular diurnal lighting cycle of ei- enough and constructed in a manner ther natural or artificial light. Light- that restricts contact with or entry by ing must be uniformly diffused humans and animals that are outside throughout animal facilities and pro- the sheltered housing facility; or vide sufficient illumination to aid in (2) The housing facility is surrounded maintaining good housekeeping prac- by a natural barrier that restricts the tices, adequate cleaning, adequate in- nonhuman primates to the housing fa- spection of animals, and for the well- cility and protects them from contact being of the animals. Primary enclo- with unauthorized humans and animals sures must be placed in the housing fa- that are outside the sheltered housing cility so as to protect the nonhuman facility, and the Administrator gives primates from excessive light. written permission (d) Shelter from the elements. Sheltered (g) Public barriers. Fixed public exhib- housing facilities for nonhuman pri- its housing nonhuman primates, such mates must provide adequate shelter as zoos, must have a barrier between from the elements at all times. They the primary enclosure and the public must provide protection from the sun, at any time the public is present, that rain, snow, wind, and cold, and from restricts physical contact between the any weather conditions that may public and the nonhuman primates. occur. Nonhuman primates used in trained (e) Capacity: multiple shelters. Both animal acts or in uncaged public exhib- the sheltered part of sheltered housing its must be under the direct control facilities and any other necessary shel- and supervision of an experienced han- ter from the elements must be suffi- dler or trainer at all times when the ciently large to provide protection public is present. Trained nonhuman comfortably to each nonhuman pri- primates may be permitted physical mate housed in the facility. If aggres- contact with the public, as allowed sive or dominant animals are housed in under § 2.131, but only if they are under the facility with other animals, there the direct control and supervision of an must be multiple shelters or other experienced handler or trainer at all means to ensure that each nonhuman times during the contact. primate has access to shelter. (f) Perimeter fence. On and after Feb- (Approved by the Office of Management and ruary 15, 1994, the outdoor area of a Budget under control number 0579–0093) sheltered housing facility must be enclosed by a fence that is of sufficient § 3.78 0utdoor housing facilities. height to keep unwanted species out. (a) Acclimation. Only nonhuman pri- Fences less than 6 feet high must be mates that are acclimated, as deter- approved by the Administrator. The mined by the attending veterinarian, fence must be constructed so that it to the prevailing temperature and hu- protects nonhuman primates by re- midity at the outdoor housing facility stricting unauthorized humans, and during the time of year they are at the animals the size of dogs, skunks, and facility, and that can tolerate the raccoons from going through it or range of temperatures and climatic under it and having contact with the conditions known to occur at the facil- nonhuman primates. It must be of suf- ity at that time of year without stress

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or discomfort, may be kept in outdoor cility and protects them from contact facilities. with unauthorized humans and animals (b) Shelter from the elements. Outdoor that are outside the housing facility, housing facilities for nonhuman pri- and the Administrator gives written mates must provide adequate shelter permission. from the elements at all times. It must (e) Public barriers. Fixed public exhib- provide protection from the sun, rain, its housing nonhuman primates, such snow, wind, and cold, and from any as zoos, must have a barrier between weather conditions that may occur. the primary enclosure and the public The shelter must safely provide heat to at any time the public is present, in the nonhuman primates to prevent the order to restrict physical contact be- ambient temperature from falling tween the public and the nonhuman below 45 °F (7.2 °C), except as directed primates. Nonhuman primates used in by the attending veterinarian and in trained animal acts or in uncaged pub- accordance with generally accepted lic exhibits must be under the direct professional and husbandry practices. control and supervision of an experi- (c) Capacity: multiple shelters. The enced handler or trainer at all times shelter must be sufficiently large to when the public is present. Trained comfortably provide protection for nonhuman primates may be allowed each nonhuman primate housed in the physical contact with the public, but facility. If aggressive or dominant ani- only if they are under the direct con- mals are housed in the facility with trol and supervision of an experienced other animals there must be multiple handler or trainer at all times during shelters, or other means to ensure pro- the contact. tection for each nonhuman primate (Approved by the Office of Management and housed in the facility. Budget under control number 0579–0093) (d) Perimeter fence. On and after Feb- ruary 15, 1994, an outdoor housing facil- § 3.79 Mobile or traveling housing fa- ity must be enclosed by a fence that is cilities. of sufficient height to keep unwanted (a) Heating, cooling, and temperature. species out. Fences less than 6 feet Mobile or traveling housing facilities high must be approved by the Adminis- must be sufficiently heated and cooled trator. The fence must be constructed when necessary to protect nonhuman so that it protects nonhuman primates primates from temperature extremes by restricting unauthorized humans, and to provide for their health and and animals the size of dogs, skunks, well-being. The ambient temperature and raccoons from going through it or in the traveling housing facility must under it and having contact with the not fall below 45 °F (7.2 °C) for more nonhuman primates. It must be of suf- than 4 consecutive hours when ficient distance from the outside wall nonhuman primates are present, and or fence of the primary enclosure to must not rise above 85 °F (29.5 °C) for prevent physical contact between ani- more than 4 consecutive hours when mals inside the enclosure and outside nonhuman primates are present. The the perimeter fence. Such fences less ambient temperature must be main- than 3 feet in distance from the pri- tained at a level that ensures the mary enclosure must be approved by health and well-being of the species the Administrator. A perimeter fence housed, as directed by the attending is not required if: veterinarian, and in accordance with (1) The outside walls of the primary generally accepted professional and enclosure are made of a sturdy, durable husbandry practices. material such as concrete, wood, plas- (b) Ventilation. Traveling housing fa- tic, metal, or glass, and are high cilities must be sufficiently ventilated enough and constructed in a manner at all times when nonhuman primates that restricts contact with or entry by are present to provide for the health humans and animals that are outside and well-being of nonhuman primates the housing facility; or and to minimize odors, drafts, ammo- (2) The housing facility is surrounded nia levels, moisture condensation, and by a natural barrier that restricts the exhaust fumes. Ventilation must be nonhuman primates to the housing fa- provided by means of windows, doors,

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vents, fans, or air conditioning. Auxil- (ii) Protect the nonhuman primates iary ventilation, such as fans, blowers, from injury; or air conditioning, must be provided (iii) Contain the nonhuman primates when the ambient temperature in the securely and prevent accidental open- traveling housing facility is 85 °F (29.5 ing of the enclosure, including opening °C) or higher. by the animal; (c) Lighting. Mobile or traveling (iv) Keep other unwanted animals housing facilities must be lighted well from entering the enclosure or having enough to permit routine inspection physical contact with the nonhuman and cleaning of the facility, and obser- primates; vation of the nonhuman primates. Ani- (v) Enable the nonhuman primates to mal areas must be provided a regular remain dry and clean; diurnal lighting cycle of either natural (vi) Provide shelter and protection or artificial light. Lighting must be from extreme temperatures and weath- uniformly diffused throughout animal er conditions that may be uncomfort- facilities and provide sufficient illu- able or hazardous to the species of mination to aid in maintaining good nonhuman primate contained; housekeeping practices, adequate (vii) Provide sufficient shade to shel- cleaning, adequate inspection of ani- ter all the nonhuman primates housed mals, and for the well-being of the ani- in the primary enclosure at one time; mals. Primary enclosures must be (viii) Provide the nonhuman pri- placed in the housing facility so as to mates with easy and convenient access protect the nonhuman primates from to clean food and water; excessive light. (ix) Enable all surfaces in contact (d) Public barriers. There must be a with nonhuman primates to be readily barrier between a mobile or traveling cleaned and sanitized in accordance housing facility and the public at any with § 3.84(b)(3) of this subpart, or re- time the public is present, in order to placed when worn or soiled; restrict physical contact between the (x) Have floors that are constructed nonhuman primates and the public. in a manner that protects the Nonhuman primates used in traveling nonhuman primates from injuring exhibits, trained animal acts, or in un- themselves; and caged public exhibits must be under (xi) Provide sufficient space for the the direct control and supervision of an nonhuman primates to make normal experienced handler or trainer at all postural adjustments with freedom of times when the public is present. movement. Trained nonhuman primates may be al- (b) Minimum space requirements. Pri- lowed physical contact with the public, mary enclosures must meet the min- but only if they are under the direct imum space requirements provided in control and supervision of an experi- this subpart. These minimum space re- enced handler or trainer at all times quirements must be met even if perch- during the contact. es, ledges, swings, or other suspended fixtures are placed in the enclosure. § 3.80 Primary enclosures. Low perches and ledges that do not allow the space underneath them to be Primary enclosures for nonhuman comfortably occupied by the animal primates must meet the following min- will be counted as part of the floor imum requirements: space. (a) General requirements. (1) Primary (1) Prior to February 15, 1994: enclosures must be designed and con- (i) Primary enclosures must be constructed of suitable materials so that structed and maintained so as to pro- they are structurally sound for the spe- vide sufficient space to allow each cies of nonhuman primates contained nonhuman primate to make normal in them. They must be kept in good re- postural adjustments with adequate pair. freedom of movement; and (2) Primary enclosures must be con- (ii) Each nonhuman primate housed structed and maintained so that they: in a primary enclosure must be pro- (i) Have no sharp points or edges that vided with a minimum floor space could injure the nonhuman primates; equal to an area at least three times

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the area occupied by the primate when other nonhuman primates, will be de- standing on four feet. termined by the typical weight of ani- (2) On and after February 15, 1994: mals of its species, except for (i) The minimum space that must be brachiating species and great apes 3 and provided to each nonhuman primate, will be calculated by using the fol- whether housed individually or with lowing table: 4

Weight Floor area/animal Height Group lbs. (kg.) ft.2 (m 2) in. (cm.)

1 ...... under 2.2 ...... (under 1) ...... 1.6 (0.15) 20 (50.8) 2 ...... 2.2–6.6 ...... (1–3) ...... 3.0 (0.28) 30 (76.2) 3 ...... 6.6–22.0 ...... (3–10) ...... 4.3 (0.40) 30 (76.2) 4 ...... 22.0–33.0 ...... (10–15) ...... 6.0 (0.56) 32 (81.28) 5 ...... 33.0–55.0 ...... (15–25) ...... 8.0 (0.74) 36 (91.44) 6 ...... over 55.0 ...... (over 25) ...... 25.1 (2.33) 84 (213.36)

(ii) Dealers. exhibitors, and research sure, the minimum space requirement facilities, including Federal research for the enclosure is the sum of the min- facilities, must provide great apes imum floor area space required for weighing over 110 lbs. (50 kg) an addi- each individual nonhuman primate in tional volume of space in excess of that the table in paragraph (b)(2)(i) of this required for Group 6 animals as set section, and the minimum height re- forth in paragraph (b)(2)(i) of this sec- quirement for the largest nonhuman tion, to allow for normal postural ad- primate housed in the enclosure. Pro- justments. vided however, that mothers with in- (iii) In the case of research facilities, fants less than 6 months of age may be any exemption from these standards maintained together in primary enclo- must be required by a research pro- sures that meet the floor area space posal or in the judgment of the attend- and height requirements of the mother. ing veterinarian and must be approved (c) Innovative primary enclosures not by the Committee. In the case of deal- precisely meeting the floor area and ers and exhibitors, any exemption from height requirements provided in para- these standards must be required in the graphs (b)(1) and (b)(2) of this section, judgment of the attending veterinarian but that do provide nonhuman pri- and approved by the Administrator. mates with a sufficient volume of space (iv) When more than one nonhuman and the opportunity to express species- primate is housed in a primary enclo-

3 The different species of nonhuman pri- and require the minimum space require- mates are divided into six weight groups for ments of lighter weight species, unless the determining minimum space requirements, animal is obviously unable to make normal except that all brachiating species of any postural adjustments and movements within weight are grouped together since they re- the primary enclosure. quire additional space to engage in species- 4 Examples of the kinds of nonhuman pri- typical behavior. The grouping provided is mates typically included in each age group based upon the typical weight for various are: species and not on changes associated with Group 1—marmosets, tamarins, and infants obesity, aging, or pregnancy. These condi- (less than 6 months of age) of various spe- tions will not be considered in determining a cies. nonhuman primate’s weight group unless the Group 2—capuchins, squirrel monkeys and animal is obviously unable to make normal similar size species, and juveniles (6 months postural adjustments and movements within to 3 years of age) of various species. the primary enclosure. Different species of Group 3—macaques and African species. prosimians vary in weight and should be Group 4—male macaques and large African grouped with their appropriate weight group. species. They have not been included in the weight Group 5—baboons and nonbrachiating spe- table since different species typically fall cies larger than 33.0 lbs. (15 kg.). into different weight groups. Infants and ju- Group 6—great apes over 55.0 lbs. (25 kg.), veniles of certain species are substantially except as provided in paragraph (b)(2)(ii) of lower in weight than adults of those species this section, and brachiating species.

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typical behavior, may be used at re- shelter by individual animals. and are search facilities when approved by the not known to be hazardous to the Committee, and by dealers and exhibi- health and well-being of each other. tors when approved by the Adminis- Compatibility of nonhuman primates trator. must be determined in accordance with (Approved by the Office of Management and generally accepted professional prac- Budget under control number 0579–0093) tices and actual observations, as directed by the attending veterinarian, § 3.81 Environment enhancement to to ensure that the nonhuman primates promote psychological well-being. are in fact compatible. Individually Dealers, exhibitors, and research fa- housed nonhuman primates must be cilities must develop, document, and able to see and hear nonhuman pri- follow an appropriate plan for environ- mates of their own or compatible spe- ment enhancement adequate to pro- cies unless the attending veterinarian mote the psychological well-being of determines that it would endanger nonhuman primates. The plan must be their health, safety, or well-being. in accordance with the currently ac- (b) Environmental enrichment. The cepted professional standards as cited physical environment in the primary in appropriate professional journals or enclosures must be enriched by pro- reference guides, and as directed by the viding means of expressing noninju- attending veterinarian. This plan must rious species-typical activities. Species be made available to APHIS upon re- differences should be considered when quest, and, in the case of research fa- determining the type or methods of en- cilities, to officials of any pertinent richment. Examples of environmental funding agency. The plan, at a min- enrichments include providing perches, imum, must address each of the fol- swings, mirrors, and other increased lowing: cage complexities; providing objects to (a) Social grouping. The environment manipulate; varied food items; using enhancement plan must include spe- foraging or task-oriented feeding meth- cific provisions to address the social ods; and providing interaction with the needs of nonhuman primates of species care giver or other familiar and knowl- known to exist in social groups in na- edgeable person consistent with per- ture. Such specific provisions must be sonnel safety precautions. in accordance with currently accepted (c) Special considerations. Certain professional standards, as cited in ap- nonhuman primates must be provided propriate professional journals or ref- special attention regarding enhance- erence guides, and as directed by the ment of their environment, based on attending veterinarian. The plan may the needs of the individual species and provide for the following exceptions: in accordance with the instructions of (1) If a nonhuman primate exhibits the attending veterinarian. Nonhuman vicious or overly aggressive behavior, primates requiring special attention or is debilitated as a result of age or are the following: other conditions (e.g., arthritis), it should be housed separately; (1) Infants and young juveniles; (2) Nonhuman primates that have or (2) Those that show signs of being in are suspected of having a contagious psychological distress through behav- disease must be isolated from healthy ior or appearance; animals in the colony as directed by (3) Those used in research for which the attending veterinarian. When an the Committee-approved protocol re- entire group or room of nonhuman pri- quires restricted activity; mates is known to have or believed to (4) Individually housed nonhuman be exposed to an infectious agent, the primates that are unable to see and group may be kept intact during the hear nonhuman primates of their own process of diagnosis, treatment, and or compatible species; and control. (5) Great apes weighing over 110 lbs. (3) Nonhuman primates may not be (50 kg). Dealers, exhibitors, and re- housed with other species of primates search facilities must include in the or animals unless they are compatible, environment enhancement plan special do not prevent access to food, water, or provisions for great apes weighing over

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110 lbs. (50 kg), including additional op- ANIMAL HEALTH AND HUSBANDRY portunities to express species-typical STANDARDS behavior. (d) Restraint devices. Nonhuman pri- § 3.82 Feeding. mates must not be maintained in re- (a) The diet for nonhuman primates straint devices unless required for must be appropriate for the species, health reasons as determined by the at- size, age, and condition of the animal, tending veterinarian or by a research and for the conditions in which the proposal approved by the Committee at nonhuman primate is maintained, ac- research facilities. Maintenance under cording to generally accepted professional and husbandry practices and nu- such restraint must be for the shortest tritional standards. The food must be period possible. In instances where clean, wholesome, and palatable to the long-term (more than 12 hours) re- animals. It must be of sufficient quan- straint is required, the nonhuman pri- tity and have sufficient nutritive value mate must be provided the opportunity to maintain a healthful condition and daily for unrestrained activity for at weight range of the animal and to meet least one continuous hour during the its normal daily nutritional require- period of restraint, unless continuous ments. restraint is required by the research (b) Nonhuman primates must be fed proposal approved by the Committee at at least once each day except as other- research facilities. wise might be required to provide ade- (e) Exemptions. (1) The attending vet- quate veterinary care. Infant and juve- erinarian may exempt an individual nile nonhuman primates must be fed as nonhuman primate from participation often as necessary in accordance with in the environment enhancement plan generally accepted professional and because of its health or condition, or in husbandry practices and nutritional consideration of its well-being. The standards, based upon the animals’ age basis of the exemption must be re- and condition. corded by the attending veterinarian (c) Food and food receptacles, if used, for each exempted nonhuman primate. must be readily accessible to all the nonhuman primates being fed. If mem- Unless the basis for the exemption is a bers of dominant nonhuman primate or permanent condition, the exemption other species are fed together with must be reviewed at least every 30 days other nonhuman primates, multiple by the attending veterinarian. feeding sites must be provided. The (2) For a research facility, the Com- animals must be observed to determine mittee may exempt an individual that all receive a sufficient quantity of nonhuman primate from participation food. in some or all of the otherwise required (d) Food and food receptacles, if used, environment enhancement plans for must be located so as to minimize any scientific reasons set forth in the re- risk of contamination by excreta and search proposal. The basis of the ex- pests. Food receptacles must be kept emption shall be documented in the ap- clean and must be sanitized in accord- proved proposal and must be reviewed ance with the procedures listed in at appropriate intervals as determined § 3.84(b)(3) of this subpart at least once by the Committee, but not less than every 2 weeks. Used food receptacles annually. must be sanitized before they can be (3) Records of any exemptions must used to provide food to a different be maintained by the dealer, exhibitor, nonhuman primate or social grouping or research facility and must be made of nonhuman primates. Measures must available to USDA officials or officials be taken to ensure there is no molding, deterioration, contamination, or cak- of any pertinent funding Federal agen- ing or wetting of food placed in self- cy upon request. feeders. (Approved by the Office of Management and Budget under control number 0579–0093) § 3.83 Watering. Potable water must be provided in sufficient quantity to every nonhuman

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primate housed at the facility. If pota- tized in accordance with this section ble water is not continually available before it can be used to house another to the nonhuman primates, it must be nonhuman primate or group of offered to them as often as necessary nonhuman primates. to ensure their health and well-being, (2) Indoor primary enclosures must but no less than twice daily for at least be sanitized at least once every 2 weeks l hour each time, unless otherwise re- and as often as necessary to prevent an quired by the attending veterinarian, excessive accumulation of dirt, debris, or as required by the research proposal waste, food waste, excreta, or disease approved by the Committee at research hazard, using one of the methods pre- facilities. Water receptacles must be scribed in paragraph (b)(3) of this sec- kept clean and sanitized in accordance tion. However, if the species of with methods provided in § 3.84(b)(3) of nonhuman primates housed in the pri- this subpart at least once every 2 mary enclosure engages in scent mark- weeks or as often as necessary to keep ing, the primary enclosure must be them clean and free from contamina- sanitized at regular intervals deter- tion. Used water receptacles must be mined in accordance with generally ac- sanitized before they can be used to cepted professional and husbandry provide water to a different nonhuman practices. primate or social grouping of (3) Hard surfaces of primary enclo- nonhuman primates. sures and food and water receptacles (Approved by the Office of Management and must be sanitized using one of the fol- Budget under control number 0579–0093) lowing methods: (i) Live steam under pressure; § 3.84 Cleaning, sanitization, house- (ii) Washing with hot water (at least keeping, and pest control. 180 °F (82.2 °C)) and soap or detergent, (a) Cleaning of primary enclosures. Ex- such as in a mechanical cage washer; creta and food waste must be removed (iii) Washing all soiled surfaces with from inside each indoor primary enclo- appropriate detergent solutions or dis- sure daily and from underneath them infectants, or by using a combination as often as necessary to prevent an ex- detergent/disinfectant product that ac- cessive accumulation of feces and food complishes the same purpose, with a waste, to prevent the nonhuman pri- thorough cleaning of the surfaces to re- mates from becoming soiled, and to remove organic material, so as to remove duce disease hazards, insects, pests, all organic material and mineral build- and odors. Dirt floors, floors with ab- up, and to provide sanitization followed sorbent bedding, and planted areas in by a clean water rinse. primary enclosures must be spot- (4) Primary enclosures containing cleaned with sufficient frequency to material that cannot be sanitized using ensure all animals the freedom to the methods provided in paragraph avoid contact with excreta, or as often (b)(3) of this section, such as sand, as necessary to reduce disease hazards, gravel, dirt, absorbent bedding, grass, insects, pests, and odors. When steam or planted areas, must be sanitized by or water is used to clean the primary removing the contaminated material enclosure, whether by hosing, flushing, as necessary to prevent odors, diseases, or other methods, nonhuman primates pests, insects, and vermin infestation. must be removed, unless the enclosure (c) Housekeeping for premises. Prem- is large enough to ensure the animals ises where housing facilities are lo- will not be harmed, wetted, or dis- cated, including buildings and sur- tressed in the process. Perches, bars, rounding grounds, must be kept clean and shelves must be kept clean and re- and in good repair in order to protect placed when worn. If the species of the the nonhuman primates from injury, to nonhuman primates housed in the pri- facilitate the husbandry practices re- mary enclosure engages in scent mark- quired in this subpart, and to reduce or ing, hard surfaces in the primary enclo- eliminate breeding and living areas for sure must be spot-cleaned daily. rodents, pests, and vermin. Premises (b) Sanitization of primary enclosures must be kept free of accumulations of and food and water receptacles. (1) A trash, junk, waste, and discarded mat- used primary enclosure must be sani- ter. Weeds, grass, and bushes must be

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controlled so as to facilitate cleaning mediate handler. The certification of the premises and pest control. must be securely attached to the out- (d) Pest control. An effective program side of the primary enclosure in a man- for control of insects, external ner that makes it easily noticed and parasites affecting nonhuman pri- read. Instructions for no food or water mates, and birds and mammals that are not acceptable unless directed by are pests, must be established and the attending veterinarian. Instruc- maintained so as to promote the health tions must be in compliance with § 3.89 and well-being of the animals and re- of this subpart. The certification must duce contamination by pests in animal include the following information for areas. each nonhuman primate: (1) The consignor’s name and address; § 3.85 Employees. (2) The species of nonhuman primate; Every person subject to the Animal (3) The time and date the animal was Welfare regulations (9 CFR parts 1, 2, last fed and watered and the specific and 3) maintaining nonhuman primates instructions for the next feeding(s) and must have enough employees to carry watering(s) for a 24-hour period; and out the level of husbandry practices and care required in this subpart. The (4) The consignor’s signature and the employees who provide husbandry date and time the certification was practices and care, or handle signed. nonhuman primates, must be trained (d) Carriers and intermediate han- and supervised by an individual who dlers must not accept a nonhuman pri- has the knowledge, background, and mate for transport in commerce unless experience in proper husbandry and the primary enclosure meets the re- care of nonhuman primates to super- quirements of § 3.87 of this subpart. A vise others. The employer must be cer- carrier or intermediate handler must tain that the supervisor can perform to not accept a nonhuman primate for these standards. transport if the primary enclosure is obviously defective or damaged and TRANSPORTATION STANDARDS cannot reasonably be expected to safely and comfortably contain the § 3.86 Consignments to carriers and intermediate handlers. nonhuman primate without suffering or injury. (a) Carriers and intermediate han- (e) Carriers and intermediate handlers must not accept a nonhuman pri- dlers must not accept a nonhuman primate for transport in commerce more mate for transport in commerce unless than 4 hours before the scheduled departure time of the primary convey- their animal holding area facilities ance on which the animal is to be meet the minimum temperature re- transported. However, a carrier or in- quirements provided in §§ 3.91 and 3.92 termediate handler may agree with of this subpart, or unless the consignor anyone consigning a nonhuman pri- provides them with a certificate signed mate to extend this time by up to 2 by a veterinarian and dated no more hours. than 10 days before delivery of the ani- (b) Carriers and intermediate han- mal to the carrier or intermediate handlers must not accept a nonhuman pri- dler for transport in commerce, certi- mate for transport in commerce unless fying that the animal is acclimated to they are provided with the name, ad- temperatures lower than those that are dress, telephone number, and telex required in §§ 3.91 and 3.92 of this sub- number, if applicable, of the consignee. part. Even if the carrier or inter- (c) Carriers and intermediate han- mediate handler receives this certifi- dlers must not accept a nonhuman pri- cation, the temperatures the mate for transport in commerce unless nonhuman primate is exposed to while the consignor certifies in writing to in the carrier’s or intermediate han- the carrier or intermediate handler dler’s custody must not be lower than that the nonhuman primate was of- the minimum temperature specified by fered food and water during the 4 hours the veterinarian in accordance with before delivery to the carrier or inter- paragraph (e)(4) of this section, and

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must be reasonably within the gen- signor or to whomever the consignor erally and professionally accepted tem- designates. The carrier or intermediate perature range for the nonhuman pri- handler must continue to provide prop- mate, as determined by the veteri- er care, feeding, and housing to the narian, considering its age, condition, nonhuman primate, and maintain the and species. A copy of the certification nonhuman primate in accordance with must accompany the nonhuman pri- generally accepted professional and mate to its destination and must in- husbandry practices until the conclude the following information for signee accepts delivery of the each primary enclosure: nonhuman primate or until it is re- (1) The consignor’s name and address; turned to the consignor or to whom- (2) The number of nonhuman pri- ever the consignor designates. The car- mates contained in the primary enclo- rier or intermediate handler must obli- sure; gate the consignor to reimburse the (3) The species of nonhuman primate carrier or intermediate handler for the contained in the primary enclosure; cost of return transportation and care. (4) A statement by a veterinarian (Approved by the Office of Management and that to the best of his or her knowl- Budget under control number 0579–0093) edge, each of the nonhuman primates contained in the primary enclosure is § 3.87 Primary enclosures used to acclimated to air temperatures lower transport nonhuman primates. than 50 °F (10 °C), but not lower than a Any person subject to the Animal minimum temperature specified on the Welfare regulations (9 CFR parts 1, 2, certificate based on the generally and and 3) must not transport or deliver for professionally accepted temperature transport in commerce a nonhuman range for the nonhuman primate, con- primate unless it is contained in a pri- sidering its age, condition, and species; mary enclosure, such as a compart- and ment, transport cage, carton, or crate, (5) The veterinarian’s signature and and the following requirements are the date the certification was signed. met: (f) When a primary enclosure con- (a) Construction of primary enclosures. taining a nonhuman primate has ar- Primary enclosures used to transport rived at the animal holding area of a nonhuman primates may be connected terminal facility after transport, the or attached to each other and must be carrier or intermediate handler must constructed so that: attempt to notify the consignee upon (1) The primary enclosure is strong arrival and at least once in every 6- enough to contain the nonhuman pri- hour period after arrival. The time, mate securely and comfortably and to date, and method of all attempted noti- withstand the normal rigors of trans- fications and the actual notification of portation; the consignee, and the name of the per- (2) The interior of the enclosure has son who notifies or attempts to notify no sharp points or edges and no protru- the consignee must be written either sions that could injure the animal con- on the carrier’s or intermediate han- tained in it; dler’s copy of the shipping document or (3) The nonhuman primate is at all on the copy that accompanies the pri- times securely contained within the mary enclosure. If the consignee can- enclosure and cannot put any part of not be notified within 24 hours after its body outside the enclosure in a way the nonhuman primate has arrived at that could result in injury to the ani- the terminal facility, the carrier or in- mal, or to persons or animals nearby; termediate handler must return the (4) The nonhuman primate can be animal to the consignor or to whom- easily and quickly removed from the ever the consignor designates. If the enclosure in an emergency; consignee is notified of the arrival and (5) The doors or other closures that does not take physical delivery of the provide access into the enclosure are nonhuman primate within 48 hours secured with animal-proof devices that after arrival of the nonhuman primate, prevent accidental opening of the en- the carrier or intermediate handler closure, including opening by the must return the animal to the con- nonhuman primate;

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(6) Unless the enclosure is perma- must be at least 8 percent of the total nently affixed to the conveyance, ade- surface area of each such wall and be quate devices such as handles or located above the midline of the enclo- handholds are provided on its exterior, sure. and enable the enclosure to be lifted (2) Unless the primary enclosure is without tilting it, and ensure that any- permanently affixed to the conveyance, one handling the enclosure will not projecting rims or similar devices must come into physical contact with the be located on the exterior of each en- animal contained inside; closure wall having a ventilation open- (7) Any material, treatment, paint, ing, in order to prevent obstruction of preservative, or other chemical used in the openings. The projecting rims or or on the enclosure is nontoxic to the similar devices must be large enough animal and not harmful to the health to provide a minimum air circulation or well-being of the animal; space of 0.75 inches (1.9 centimeters) (8) Proper ventilation is provided to between the primary enclosure and the nonhuman primate in accordance anything the enclosure is placed with paragraph (c) of this section; against. (9) Ventilation openings are covered (3) If a primary enclosure is perma- with bars, wire mesh, or smooth ex- nently affixed to the primary convey- panded metal having air spaces; and ance so that there is only a front ven- (10) The primary enclosure has a tilation opening for the enclosure, the solid, leak-proof bottom, or a remov- primary enclosure must be affixed to able, leak-proof collection tray under a the primary conveyance in such a way slatted or wire mesh floor that pre- that the front ventilation opening can- vents seepage of waste products, such not be blocked, and the front ventila- as excreta and body fluids, outside of tion opening must open directly to an the enclosure. If a slatted or wire mesh unobstructed aisle or passageway in- floor is used in the enclosure, it must side of the conveyance. The ventilation be designed and constructed so that the opening must be at least 90 percent of animal cannot put any part of its body the total area of the front wall of the between the slats or through the holes enclosure, and must be covered with in the mesh. It must contain enough bars, wire mesh, or smooth expanded previously unused litter to absorb and metal having air spaces. cover excreta. The litter must be of a (d) Compatibility. (1) Only one live suitably absorbent material that is nonhuman primate may be transported safe and nontoxic to the nonhuman pri- in a primary enclosure, except as fol- mate and is appropriate for the species lows: transported in the primary enclosure. (i) A mother and her nursing infant (b) Cleaning of primary enclosures. A may be transported together; primary enclosure used to hold or (ii) An established male-female pair transport nonhuman primates in com- or family group may be transported to- merce must be cleaned and sanitized gether, except that a female in estrus before each use in accordance with the must not be transported with a male methods provided in § 3.84(b)(3) of this nonhuman primate; subpart. (iii) A compatible pair of juveniles of (c) Ventilation. (1) If the primary en- the same species that have not reached closure is movable, ventilation open- puberty may be transported together. ings must be constructed in one of the (2) Nonhuman primates of different following ways: species must not be transported in ad- (i) If ventilation openings are located jacent or connecting primary enclo- on two opposite walls of the primary sures. enclosure, the openings on each wall (e) Space requirements. Primary enclo- must be at least 16 percent of the total sures used to transport nonhuman pri- surface area of each such wall and be mates must be large enough so that located above the midline of the enclo- each animal contained in the primary sure; or enclosure has enough space to turn (ii) If ventilation openings are lo- around freely in a normal manner and cated on all four walls of the primary to sit in an upright, hands down posi- enclosure, the openings on every wall tion without its head touching the top

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of the enclosure. However, certain larg- (b) The animal cargo space must have er species may be restricted in their a supply of air that is sufficient for the movements, in accordance with profes- normal breathing of all the animals sionally accepted standards of care, being transported in it. when greater freedom of movement (c) Each primary enclosure con- would be dangerous to the animal, its taining nonhuman primates must be handler, or to other persons. positioned in the animal cargo space in (f) Marking and labeling. Primary en- a manner that provides protection closures, other than those that are per- from the elements and that allows each manently affixed to a conveyance, nonhuman primate enough air for nor- must be clearly marked in English on mal breathing. the top and on one or more sides with (d) During air transportation, the the words ‘‘Wild Animals,’’ or ‘‘Live ambient temperature inside a primary Animals,’’ in letters at least 1 inch (2.5 conveyance used to transport cm.) high, and with arrows or other nonhuman primates must be main- markings to indicate the correct up- tained at a level that ensures the right position of the primary enclo- health and well-being of the species sure. Permanently affixed primary en- housed, in accordance with generally closures must be clearly marked in accepted professional and husbandry English with the words ‘‘Wild Ani- practices, at all times a nonhuman pri- mals’’ or ‘‘Live Animals,’’ in the same mate is present. manner. (e) During surface transportation, (g) Accompanying documents and the ambient temperature inside a pri- records. Shipping documents that must mary conveyance used to transport accompany shipments of nonhuman nonhuman primates must be main- primates may be held by the operator tained between 45 °F (7.2 °C) and 85 °F of the primary conveyance, for surface (30 °C) at all times a nonhuman pri- transportation only, or must be se- mate is present. curely attached in a readily accessible (f) A primary enclosure containing a manner to the outside of any primary nonhuman primate must be placed far enclosure that is part of the shipment, enough away from animals that are in a manner that allows them to be de- predators or natural enemies of tached for examination and securely nonhuman primates, whether the other reattached, such as in a pocket or animals are in primary enclosures or sleeve. Instructions for administration not, so that the nonhuman primate of drugs, medication, and other special cannot touch or see the other animals. care must be attached to each primary (g) Primary enclosures must be posi- enclosure in a manner that makes tioned in the primary conveyance in a them easy to notice, to detach for ex- manner that allows the nonhuman pri- amination, and to reattach securely. mates to be quickly and easily re- Food and water instructions must be moved from the primary conveyance in attached in accordance with § 3.86(c) of an emergency. this subpart. (h) The interior of the animal cargo (Approved by the Office of Management and space must be kept clean Budget under control number 0579–0093) (i) Nonhuman primates must not be transported with any material, sub- § 3.88 Primary conveyances (motor ve- stance (e.g., dry ice), or device in a hicle, rail, air, and marine). manner that may reasonably be ex- (a) The animal cargo space of pri- pected to harm the nonhuman primates mary conveyances used to transport or cause inhumane conditions. nonhuman primates must be designed, constructed, and maintained in a man- § 3.89 Food and water requirements. ner that at all times protects the (a) Each nonhuman primate that is 1 health and well-being of the animals year of age or more must be offered transported in it, ensures their safety food 5 at least once every 24 hours. and comfort, and prevents the entry of engine exhaust from the primary con- 5 Proper food for purposes of this section is veyance during transportation. described in § 3.82 of this subpart, with the

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Each nonhuman primate that is less leave the primary enclosure through than 1 year of age must be offered food the food or water opening. at least once every 12 hours. Each (Approved by the Office of Management and nonhuman primate must be offered po- Budget under control number 0579–0093) table water at least once every 12 hours. These time periods apply to § 3.90 Care in transit. dealers, exhibitors, and research facilities, including Federal research facili- (a) Surface transportation (ground and ties, who transport nonhuman pri- water). Any person subject to the Ani- mates in their own primary convey- mal Welfare regulations (9 CFR parts 1, ances, starting from the time the 2, and 3) transporting nonhuman pri- nonhuman primate was last offered mates in commerce must ensure that food and potable water before transpor- the operator of the conveyance or a tation was begun. These time periods person accompanying the operator of apply to carriers and intermediate han- the conveyance observes the nonhuman dlers starting from the date and time primates as often as circumstances stated on the certification provided allow, but not less than once every 4 under § 3.86(c) of this subpart. Each hours, to make sure that they have suf- nonhuman primate must be offered ficient air for normal breathing, that food and potable water within 4 hours the ambient temperature is within the before being transported in commerce. limits provided in § 3.88(d) of this sub- Consignors who are subject to the Ani- part, and that all other applicable mal Welfare regulations (9 CFR parts 1, standards of this subpart are being 2, and 3) must certify that each complied with. The regulated person nonhuman primate was offered food transporting the nonhuman primates and potable water within the 4 hours must ensure that the operator or the preceding delivery of the nonhuman person accompanying the operator de- primate to a carrier or intermediate termines whether any of the nonhuman handler for transportation in com- primates are in obvious physical dis- merce, and must certify the date and tress, and obtains any veterinary care time the food and potable water was of- needed for the nonhuman primates at fered, in accordance with § 3.86(c) of the closest available veterinary facil- this subpart. ity. (b) Any dealer, exhibitor, or research (b) Air transportation. During air facility, including a Federal research transportation of nonhuman primates, facility, offering a nonhuman primate it is the responsibility of the carrier to to a carrier or intermediate handler for observe the nonhuman primates as fre- transportation in commerce must sequently as circumstances allow, but curely attach to the outside of the pri- not less than once every 4 hours if the mary enclosure used for transporting animal cargo area is accessible during the nonhuman primate, written in- flight. If the animal cargo area is not structions for a 24-hour period for the accessible during flight, the carrier in-transit food and water requirements must observe the nonhuman primates of the nonhuman primate(s) contained whenever they are loaded and unloaded in the enclosure. The instructions must and whenever the animal cargo space is be attached in a manner that makes otherwise accessible to make sure that them easily noticed and read. the nonhuman primates have sufficient (c) Food and water receptacles must air for normal breathing, that the am- be securely attached inside the pri- bient temperature is within the limits mary enclosure and placed so that the provided in § 3.88(d) of this subpart, and receptacles can be filled from outside that all other applicable standards of of the enclosure without opening the this subpart are being complied with. door. Food and water receptacles must The carrier must determine whether be designed, constructed, and installed any of the nonhuman primates is in ob- so that a nonhuman primate cannot vious physical distress, and arrange for any needed veterinary care for the necessities and circumstances of the mode of nonhuman primates as soon as pos- travel taken into account. sible.

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(c) If a nonhuman primate is obvi- The air must be circulated by fans, ously ill, injured, or in physical dis- blowers, or air conditioning so as to tress, it must not be transported in minimize drafts, odors, and moisture commerce, except to receive veterinary condensation. Auxiliary ventilation, care for the condition. such as exhaust fans, vents, fans, blow- (d) During transportation in com- ers, or air conditioning, must be used merce, a nonhuman primate must not in any animal holding area containing be removed from its primary enclosure nonhuman primates when the ambient unless it is placed in another primary temperature is 85 °F (29.5 °C) or higher. enclosure or a facility that meets the (d) Temperature. The ambient tem- requirements of § 3.80 or § 3.87 of this perature in an animal holding area subpart. Only persons who are experi- containing nonhuman primates must enced and authorized by the shipper, or not fall below 45 °F (7.2 °C) or rise authorized by the consignor or the con- above 85 °F (29.5 °C) for more than four signee upon delivery, if the animal is consecutive hours at any time consigned for transportation, may re- nonhuman primates are present. The move nonhuman primates from their ambient temperature must be meas- primary enclosure during transpor- ured in the animal holding area by the tation in commerce, unless required for carrier, intermediate handler, or a per- the health or well-being of the animal. son transporting nonhuman primates (e) The transportation regulations who is subject to the Animal Welfare contained in this subpart must be com- regulations (9 CFR parts 1, 2, and 3), plied with until a consignee takes outside any primary enclosure con- physical delivery of the animal if the taining a nonhuman primate at a point animal is consigned for transportation, not more than 3 feet (0.91 m.) away or until the animal is returned to the from an outside wall of the primary en- consignor. closure, on a level that is even with the enclosure and approximately midway § 3.91 Terminal facilities. up the side of the enclosure. (a) Placement. Any persons subject to (e) Shelter. Any person subject to the the Animal Welfare regulations (9 CFR Animal Welfare regulations (9 CFR parts l, 2, and 3) must not commingle parts l, 2, and 3) holding a nonhuman shipments of nonhuman primates with primate in an animal holding area of a inanimate cargo or with other animals terminal facility must provide the fol- in animal holding areas of terminal fa- lowing: cilities. Nonhuman primates must not (1) Shelter from sunlight and extreme be placed near any other animals, in- heat. Shade must be provided that is cluding other species of nonhuman pri- sufficient to protect the nonhuman primates, and must not be able to touch mate from the direct rays of the sun. or see any other animals, including (2) Shelter from rain or snow. Suffi- other species of nonhuman primates. cient protection must be provided to (b) Cleaning, sanitization, and pest con- allow nonhuman primates to remain trol. All animal holding areas of ter- dry during rain, snow, and other pre- minal facilities must be cleaned and cipitation. sanitized in a manner prescribed in (f) Duration. The length of time any § 3.84(b)(3) of this subpart, as often as person subject to the Animal Welfare necessary to prevent an accumulation regulations (9 CFR parts 1, 2, and 3) can of debris or excreta and to minimize hold a nonhuman primate in an animal vermin infestation and disease hazards. holding area of a terminal facility Terminal facilities must follow an ef- upon arrival is the same as that pro- fective program in all animal holding vided in § 3.86(f) of this subpart. areas for the control of insects, ectoparasites, and birds and mammals § 3.92 Handling. that are pests of nonhuman primates. (a) Any person subject to the Animal (c) Ventilation. Ventilation must be Welfare regulations (9 CFR parts 1, 2, provided in any animal holding area in and 3) who moves (including loading a terminal facility containing and unloading) nonhuman primates nonhuman primates by means of win- within, to, or from the animal holding dows, doors, vents, or air conditioning. area of a terminal facility or a primary

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conveyance must do so as quickly and tioned in the manner that written in- efficiently as possible, and must pro- structions and arrows on the outside of vide the following during movement of the primary enclosure indicate. the nonhuman primate: (c) This section applies to movement (1) Shelter from sunlight and extreme of a nonhuman primate from primary heat. Sufficient shade must be provided conveyance to primary conveyance, to protect the nonhuman primate from within a primary conveyance or ter- the direct rays of the sun. A nonhuman minal facility, and to or from a ter- primate must not be exposed to an am- minal facility or a primary convey- bient temperature above 85 °F (29.5 °C) ance. for a period of more than 45 minutes (Approved by the Office of Management and while being moved to or from a pri- Budget under control number 0579–0093) mary conveyance or a terminal facility, The ambient temperature must be Subpart E—Specifications for the measured in the manner provided in § 3.91(d) of this subpart. Humane Handling, Care, (2) Shelter from rain or snow. Suffi- Treatment, and Transportation cient protection must be provided to of Marine Mammals allow nonhuman primates to remain dry during rain, snow, and other pre- SOURCE: 44 FR 36874, June 22, 1979, unless cipitation. otherwise noted. (3) Shelter from cold temperatures. FACILITIES AND OPERATING STANDARDS Transporting devices on which nonhuman primates are placed to move § 3.100 Special considerations regard- them must be covered to protect the ing compliance and/or variance. animals when the outdoor temperature (a) All persons subject to the Animal falls below 45 °F (7.2 °C). A nonhuman Welfare Act who maintain or otherwise primate must not be exposed to an am- handle marine mammals in captivity bient air temperature below 45 °F (7.2 ° must comply with the provisions of C) for a period of more than 45 min- this subpart, except that they may utes, unless it is accompanied by a cer- apply for and be granted a variance, 6 tificate of acclimation to lower tem- by the Deputy Administrator, from one peratures as provided in § 3.86(e) of this or more specified provisions of § 3.104. subpart. The ambient temperature The provisions of this subpart shall not must be measured in the manner pro- apply, however, in emergency cir- vided in § 3.91(d) of this subpart. cumstances where compliance with one (b) Any person handling a primary or more requirements would not serve enclosure containing a nonhuman pri- the best interest of the marine mam- mate must use care and must avoid mals concerned. causing physical harm or distress to (b) An application for a variance the nonhuman primate. must be made to the Deputy Adminis- (1) A primary enclosure containing a trator in writing. The request must in- nonhuman primate must not be placed clude: on unattended conveyor belts or on ele- (1) The species and number of ani- vated conveyor belts, such as baggage mals involved, claim conveyor belts and inclined con- (2) A statement from the attending veyor ramps that lead to baggage claim veterinarian concerning the age and areas, at any time; except that a pri- health status of the animals involved, mary enclosure may be placed on in- and concerning whether the granting of clined conveyor ramps used to load and a variance would be detrimental to the unload aircraft if an attendant is marine mammals involved, present at each end of the conveyor (3) Each provision of the regulations belt. that is not met, (2) A primary enclosure containing a nonhuman primate must not be tossed, 6 Written permission from the Deputy Ad- dropped, or needlessly tilted, and must ministrator to operate as a licensee or reg- not be stacked in a manner that may istrant under the Act without being in full reasonably be expected to result in its compliance with one or more specified provi- falling. It must be handled and posi- sions of § 3.104.

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(4) The time period requested for a (f) Any facility housing marine mam- variance, mals that does not meet all of the (5) The specific reasons why a vari- space requirements as of July 30, 1984, ance is requested, and must meet all of the requirements by (6) The estimated cost of coming into September 28, 1984, or may operate compliance, if construction is involved. without meeting such requirements (c) After receipt of an application for until action is taken on an application a variance, the Deputy Administrator for a variance if the application is sub- may require the submission in writing mitted to the Deputy Administrator on of a report by two experts rec- or before September 28, 1984. ommended by the American Associa- (g) A research facility may be grant- tion of Zoological Parks and Aquar- ed a variance from specified require- iums and approved by the Deputy Ad- ments of this subpart when such vari- ministrator concerning potential ad- ance is necessary for research purposes verse impacts on the animals involved and is fully explained in the experi- or on other matters relating to the ef- mental design. Any time limitation fects of the requested variance on the stated in this section shall not be ap- health and well-being of such marine plicable in such case. mammals. Such a report will be re- [49 FR 26681, June 28, 1984; 63 FR 2, Jan. 2, quired only in those cases when the 1998] Deputy Administrator determines that such expertise is necessary to deter- § 3.101 Facilities, general. mine whether the granting of a vari- (a) Construction requirements. (1) In- ance would cause a situation detri- door and outdoor housing facilities for mental to the health and well-being of marine mammals must be structurally the marine mammals involved. The sound and must be maintained in good cost of such report is to be paid by the repair to protect the animals from in- applicant. jury, to contain the animals within the (d) Variances granted for facilities facility, and to restrict the entrance of because of ill or infirm marine mam- unwanted animals. Lagoon and similar mals that cannot be moved without natural seawater facilities must main- placing their well-being in jeopardy, or tain effective barrier fences extending for facilities within 0.3048 meters (1 above the high tide water level, or foot) of compliance with any space re- other appropriate measures, on all quirement may be granted for up to the sides of the enclosure not contained by life of the marine mammals involved. dry land to fulfill the requirements of Otherwise, variances shall be granted this section. for a period not exceeding July 30, 1986, (2) All marine mammals must be pro- Provided, however, That under cir- vided with protection from abuse and cumstances deemed justified by the harassment by the viewing public by Deputy Administrator, a maximum ex- the use of a sufficient number of uni- tension of 1 year may be granted to at- formed or readily identifiable employ- tain full compliance. A written request ees or attendants to supervise the for the extension must be received by viewing public, or by physical barriers, the Deputy Administrator by May 30, such as fences, walls, glass partitions, 1986. Consideration for extension by the or distance, or any combination of Deputy Administrator will be limited these. to unforeseen or unusual situations (3) All surfaces in a primary enclo- such as when necessary public funds sure must be constructed of durable, cannot be allocated in an appropriate nontoxic materials that facilitate time frame for a facility to attain full cleaning, and disinfection as appro- compliance by July 30, 1986. priate, sufficient to maintain water (e) The Deputy Administrator shall quality parameters as designated in deny any application for a variance if § 3.106. All surfaces must be maintained he determines that it is not justified in good repair as part of a regular, on- under the circumstances or that allow- going maintenance program. All facili- ing it will be detrimental to the health ties must implement a written protocol and well-being of the marine mammals on cleaning so that surfaces do not involved. constitute a health hazard to animals.

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(4) Facilities that utilize natural Refrigerators and freezers (or chilled water areas, such as tidal basins, bays, and/or iced coolers for under 12 hours) or estuaries (subject to natural tide- must be used for perishable food. No water action), for housing marine substances that are known to be or mammals are exempt from the drain- may be toxic or harmful to marine age requirements of paragraph (c)(1) of mammals may be stored or maintained this section. in the marine mammal food storage or (b) Water and power supply. Reliable preparation areas, except that cleaning and adequate sources of water and elec- agents may be kept in secured cabinets tric power must be provided by the fa- designed and located to prevent food cility housing marine mammals. Writ- contamination. Food, supplements, and ten contingency plans must be sub- medications may not be used beyond mitted to and approved by the Deputy commonly accepted shelf life or date Administrator regarding emergency sources of water and electric power in listed on the label. the event of failure of the primary (e) Waste disposal. Provision must be sources, when such failure could rea- made for the removal and disposal of sonably be expected to be detrimental animal and food wastes, dead animals, to the good health and well-being of trash, and debris. Disposal facilities the marine mammals housed in the fa- must be provided and operated in a cility. Contingency plans must include, manner that will minimize odors and but not be limited to, specific animal the risk of vermin infestation and dis- evacuation plans in the event of a disease hazards. All waste disposal proce- aster and should describe back-up sys- dures must comply with all applicable tems and/or arrangements for relo- Federal, State, and local laws per- cating marine mammals requiring arti- taining to pollution control, protection ficially cooled or heated water. If the of the environment, and public health. emergency contingency plan includes (f) Employee washroom facilities. Wash- release of marine mammals, the plan room facilities containing basins, must include provision for recall train- sinks, and, as appropriate, showers, ing and retrieval of such animals. must be provided and conveniently lo- (c) Drainage. (1) Adequate drainage cated to maintain cleanliness among must be provided for all primary enclo- employees, attendants, and volunteers. sure pools and must be located so that These facilities must be cleaned and all of the water contained in such pools sanitized daily. may be effectively eliminated when necessary for cleaning the pool or for (g) Enclosure or pool environmental en- other purposes. Drainage effluent from hancements. Any nonfood objects pro- primary enclosure pools must be dis- vided for the entertainment or stimula- posed of in a manner that complies tion of marine mammals must be of with all applicable Federal, State, and sufficient size and strength to not be local pollution control laws. ingestible, readily breakable, or likely (2) Drainage must be provided for pri- to cause injury to marine mammals, mary enclosures and areas imme- and be able to be cleaned, sanitized, diately surrounding pools. All drain and/or replaced effectively. covers and strainers must be securely fastened in order to minimize the po- [66 FR 251, Jan. 3, 2001] tential risk of animal entrapment. EFFECTIVE DATE NOTE: At 77 FR 76824, Dec. Drains must be located so as to rapidly 31, 2012, § 3.101 was amended by adding a new eliminate excess water (except in sentence at the end of paragraph (b), effec- pools). Drainage effluent must be dis- tive Jan. 30, 2013. For the convenience of the posed of in a manner that complies user, the added text is set forth as follows: with all applicable Federal, State, and § 3.101 Facilities, general. local pollution control laws. (d) Storage. Supplies of food must be stored in facilities that adequately pro- * * * * * tect such supplies from deterioration, (b) * * * Facilities handling marine mam- spoilage (harmful microbial growth), mals must also comply with the require- and vermin or other contamination. ments of § 2.134 of this subchapter.

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§ 3.102 Facilities, indoor. may encounter during the period they (a) Ambient temperature. The air and are so housed do not adversely affect water temperatures in indoor facilities their health and comfort. A marine shall be sufficiently regulated by heat- mammal shall not be introduced to an ing or cooling to protect the marine outdoor housing facility until it is ac- mammals from extremes of tempera- climated to the air and water temperature, to provide for their good health ture ranges which it will encounter and well-being and to prevent discom- therein. The following requirements fort, in accordance with the currently shall be applicable to all outdoor pools. accepted practices as cited in appro- (1) The water surface of pools in out- priate professional journals or ref- door primary enclosures housing polar erence guides, depending upon the spe- bears and ice or cold water dwelling cies housed therein. Rapid changes in species of pinnipeds shall be kept suffi- air and water temperatures shall be ciently free of solid ice to allow for avoided. entry and exit of the animals. (b) Ventilation. Indoor housing facili- (2) The water surface of pools in out- ties shall be ventilated by natural or door primary enclosures housing artificial means to provide a flow of cetaceans and sea otters shall be kept fresh air for the marine mammals and free of ice. to minimize the accumulation of chlo- (3) No sirenian or warm water dwell- rine fumes, other gases, and objection- ing species of pinnipeds or cetaceans able odors. A vertical air space aver- shall be housed in outdoor pools where aging at least 1.83 meters (6 feet) shall water temperature cannot be main- be maintained in all primary enclo- tained within the temperature range to sures housing marine mammals, in- meet their needs. cluding pools of water. (b) Shelter. Natural or artificial shel- (c) Lighting. Indoor housing facilities ter which is appropriate for the species for marine mammals shall have ample concerned, when the local climatic lighting, by natural or artificial conditions are taken into consider- means, or both, of a quality, distribu- ation, shall be provided for all marine tion, and duration which is appropriate mammals kept outdoors to afford them for the species involved. Sufficient protection from the weather or from lighting must be available to provide direct sunlight. uniformly distributed illumination (c) Perimeter fence. On and after May which is adequate to permit routine in- 17, 2000, all outdoor housing facilities spections, observations, and cleaning of (i.e., facilities not entirely indoors) all parts of the primary enclosure in- must be enclosed by a perimeter fence cluding any den areas. The lighting that is of sufficient height to keep ani- shall be designed so as to prevent over- mals and unauthorized persons out. exposure of the marine mammals con- Fences less than 8 feet high for polar tained therein to excessive illumina- bears or less than 6 feet high for other tion. 7 marine mammals must be approved in writing by the Administrator. The [44 FR 36874, June 22, 1979; 63 FR 2, Jan. 2, fence must be constructed so that it 1998] protects marine mammals by restrict- § 3.103 Facilities, outdoor. ing animals and unauthorized persons from going through it or under it and (a) Environmental temperatures. Ma- having contact with the marine mam- rine mammals shall not be housed in mals, and so that it can function as a outdoor facilities unless the air and secondary containment system for the water temperature ranges which they animals in the facility when appropriate. The fence must be of sufficient 7 Lighting intensity and duration must be distance from the outside of the pri- consistent with the general well-being and mary enclosure to prevent physical comfort of the animal involved. When pos- contact between animals inside the en- sible, it should approximate the lighting conditions encountered by the animal in its closure and animals or persons outside natural environment. At no time shall the the perimeter fence. Such fences less lighting be such that it will cause the animal than 3 feet in distance from the pri- discomfort or trauma. mary enclosure must be approved in

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writing by the Administrator. For nat- poses. If maintenance in such enclo- ural seawater facilities, such as la- sures for nonmedical training, breed- goons, the perimeter fence must pre- ing, or holding is to last longer than 2 vent access by animals and unauthor- weeks, such extension must be justified ized persons to the natural seawater fa- in writing by the attending veteri- cility from the abutting land, and must narian on a weekly basis. If mainte- encompass the land portion of the fa- nance in such enclosures for transfer is cility from one end of the natural sea- to last longer than 1 week, such exten- water facility shoreline as defined by sion must be justified in writing by the low tide to the other end of the natural attending veterinarian on a weekly seawater facility shoreline defined by basis. Any enclosure that does not low tide. A perimeter fence is not re- meet the minimum space requirement quired: for primary enclosures (including, but (1) Where the outside walls of the pri- not limited to, medical pools or enclo- mary enclosure are made of sturdy, du- sures, holding pools or enclosures, and rable material, which may include cer- gated side pools smaller than the min- tain types of concrete, wood, plastic, imum space requirements) may not be metal, or glass, and are high enough used for permanent housing purposes. and constructed in a manner that re- Rotating animals between enclosures stricts entry by animals and unauthor- that meet the minimum space require- ized persons and the Administrator ments and enclosures that do not is not gives written approval; or an acceptable means of complying with (2) Where the outdoor housing facil- the minimum space requirements for ity is protected by an effective natural primary enclosures. barrier that restricts the marine mam- (b) Cetaceans. Primary enclosures mals to the facility and restricts entry housing cetaceans shall contain a pool by animals and unauthorized persons of water and may consist entirely of a and the Administrator gives written pool of water. In determining the min- approval; or imum space required in a pool holding (3) Where appropriate alternative se- cetaceans, four factors must be satis- curity measures are employed and the fied. These are MHD, depth, volume, Administrator gives written approval; and surface area. For the purposes of or this subpart, cetaceans are divided into (4) For traveling facilities where ap- Group I cetaceans and Group II propriate alternative security meas- cetaceans as shown in Table III in this ures are employed. section. [44 FR 36874, June 22, 1979, as amended at 64 (1)(i) The required minimum horizontal FR 56147, Oct. 18, 1999] dimension (MHD) of a pool for Group I cetaceans shall be 7.32 meters (24.0 feet) § 3.104 Space requirements. or two times the average adult length (a) General. Marine mammals must be of the longest species of Group I ceta- housed in primary enclosures that cean housed therein (as measured in a comply with the minimum space re- parallel or horizontal line, from the tip quirements prescribed by this part. of its upper jaw, or from the most ante- These enclosures must be constructed rior portion of the head in bulbous and maintained so that the animals headed animals, to the notch in the contained within are provided suffi- tail fluke 8 ), whichever is greater; ex- cient space, both horizontally and cept that such MHD measurement may vertically, to be able to make normal be reduced from the greater number by postural and social adjustments with adequate freedom of movement, in or 8 The body length of a Monodon monoceros out of the water. (An exception to (narwhale) is measured from the tip of the these requirements is provided in upper incisor tooth to the notch in the tail § 3.110(b) for isolation or separation for fluke. If the upper incisor is absent or does medical treatment and/or medical not extend beyond the front of the head, then it is measured like other cetaceans, from the training.) Enclosures smaller than re- tip of the upper jaw to the notch in the tail quired by the standards may be tempo- fluke. Immature males should be anticipated rarily used for nonmedical training, to develop the ‘‘tusk’’ (usually left incisor breeding, holding, and transfer pur- tooth) beginning at sexual maturity.

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up to 20 percent if the amount of the to 20 percent if the amount of the re- reduction is added to the MHD at the duction is added to the MHD at the 90- 90-degree angle and if the minimum degree angle and if the minimum vol- volume and surface area requirements ume and surface area requirements are are met based on an MHD of 7.32 me- met based on an MHD of 7.32 meters ters (24.0 feet) or two times the average (24.0 feet) or four times the average adult length of the longest species of adult length of the longest species of Group I cetacean housed therein, Group II cetacean housed therein, whichever is greater. whichever is greater. (ii) The MHD of a pool for Group II (iii) In a pool housing a mixture of cetaceans shall be 7.32 meters (24.0 feet) Group I and Group II cetaceans, the or four times the average adult length MHD shall be the largest required for of the longest species of cetacean to be any cetacean housed therein. housed therein (as measured in a par- (iv) Once the required MHD has been allel or horizontal line from the tip of satisfied, the pool size may be required its upper jaw, or from the most ante- to be adjusted to increase the surface rior portion of the head in bulbous area and volume when cetaceans are headed animals, to the notch in the added. Examples of MHD and volume tail fluke), whichever is greater; except requirements for Group I cetaceans are that such MHD measurement may be shown in Table I, and for Group II reduced from the greater number by up cetaceans in Table II.

TABLE I—GROUP I CETACEANS 1

Representative average adult Minimum horizontal dimen- Minimum required depth Volume of water required for lengths sion (MHD) each additional cetacean in excess of two Meters Feet Meters Feet Meters Feet Cubic meters feet

1.68 5 .5 7 .32 24 1 .83 6 8 .11 284 .95 2.29 7 .5 7 .32 24 1 .83 6 15 .07 529.87 2.74 9 .0 7 .32 24 1 .83 6 21 .57 763.02 3.05 10 .0 7 .32 24 1.83 6 26 .73 942.00 3.51 11 .5 7 .32 24 1.83 6 35 .40 1,245.79 3.66 12 .0 7 .32 24 1.83 6 38 .49 1,356.48 4.27 14 .0 8 .53 28 2.13 7 60 .97 2,154.04 5.49 18 .0 10 .97 36 2 .74 9 129.65 4,578 .12 5.64 18 .5 11 .28 37 2 .82 9 .25 140.83 4,970 .33 5.79 19 .0 11 .58 38 2 .90 9 .50 152.64 5,384 .32 6.71 22 .0 13 .41 44 3 .36 11 237.50 8,358 .68 6.86 22 .5 13 .72 45 3 .43 11 .25 253.42 8,941 .64 7.32 24 .0 14 .63 48 3 .66 12 307.89 10,851 .84 8.53 28 .0 17 .07 56 4 .27 14 487.78 17,232 .32

1 All calculations are rounded off to the nearest hundredth. In converting the length of cetaceans from feet to meters, 1 foot equals .3048 meter. Due to rounding of meter figures as to the length of the cetacean, the correlation of meters to feet in subsequent calculations of MHD and additional volume of water required per cetacean, over two, may vary slightly from a strict feet to meters ratio. Cubic meters is based on: 1 cubic foot=0.0283 cubic meter.

TABLE II—GROUP II CETACEANS 1

Representative average adult Minimum horizontal dimen- Minimum required depth Volume of water required for length sion (MHD) each additional cetacean in excess of four Meters Feet Meters Feet Meters Feet Cubic me- Cubic feet ters 1

1.52 5 .0 7 .32 24 1 .83 6 13 .28 471.00 1.68 5 .5 7 .32 24 1 .83 6 16 .22 569.91 1.83 6 .0 7 .32 24 1 .83 6 19 .24 678.24 2.13 7 .0 8 .53 28 1 .83 6 26 .07 923.16 2.29 7 .5 9 .14 30 1 .83 6 30 .13 1,059 .75 2.44 8 .0 9 .75 32 1 .83 6 34 .21 1,205 .76 2.59 8 .5 10 .36 34 1.83 6 38 .55 1,361.19 2.74 9 .0 10 .97 36 1.83 6 43 .14 1,526.04

1 Converting cubic feet to cubic meters is based on: 1 cubic foot=0.0283 of a cubic meter.

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TABLE III—AVERAGE ADULT LENGTHS OF MARINE MAMMALS MAINTAINED IN CAPTIVITY 1

Average adult length Species Common name In meters In feet

Group I Cetaceans: Balaenoptera acutorostrata ...... Minke whale ...... 8 .50 27 .9 Cephalorhynchus commersonii ...... Commerson’s dolphin ...... 1 .52 5 .0 Delphinapterus leucas ...... Beluga whale ...... 4 .27 14 .0 Monodon monoceros ...... Narwhale ...... 3 .96 13 .0 Globicephala melaena ...... Long-finned pilot whale ...... 5 .79 19 .0 Globicephala macrorhynchus ...... Short-finned pilot whale ...... 5 .49 18.0 Grampus griseus ...... Risso’s dolphin ...... 3.66 12 .0 Orcinus orca ...... Killer whale ...... 7.32 24 .0 Pseudorca carassidens ...... False killer whale ...... 4 .35 14.3 Tursiops truncatus (Atlantic) ...... Bottlenose dolphin ...... 2 .74 9 .0 Tursiops truncatus (Pacific) ...... Bottlenose dolphin ...... 3 .05 10.0 Inia geoffrensis ...... Amazon porpoise ...... 2 .44 8 .0 Phocoena phocoena ...... Harbor porpoise ...... 1 .68 5 .5 Pontoporia blainvillei ...... Franciscana ...... 1 .52 5 .0 Sotalia fluviatilis ...... Tucuxi ...... 1 .68 5 .5 Platanista, all species ...... River dolphin ...... 2.44 8 .0 Group II Cetaceans: Delphinus delphis ...... Common dolphin ...... 2.59 8 .5 Feresa attenuata ...... Pygmy killer whale ...... 2 .44 8 .0 Kogia breviceps ...... Pygmy sperm whale ...... 3 .96 13 .0 Kogia simus ...... Dwarf sperm whale ...... 2 .90 9 .5 Lagenorhynchus acutus ...... Atlantic white-sided dolphin ...... 2 .90 9 .5 Lagenorhynchus cruciger ...... Hourglass dolphin ...... 1.70 5 .6 Lagenorhynchus obliquidens ...... Pacific white-sided dolphin ...... 2 .29 7.5 Lagenorhynchus albirostris ...... White-beaked dolphin ...... 2.74 9 .0 Lagenorhynchus obscurus ...... Duskey dolphin ...... 2 .13 7.0 Lissodelphis borealis ...... Northern right whale dolphin ...... 2 .74 9 .0 Neophocaena phocaenoides ...... Finless porpoise ...... 1.83 6 .0 Peponocephala electra ...... Melon-headed whale ...... 2.74 9 .0 Phocoenoides dalli ...... Dall’s porpoise ...... 2.00 6 .5 Stenella longirostris ...... Spinner dolphin ...... 2 .13 7 .0 Stenella coeruleoalba ...... Striped dolphin ...... 2 .29 7 .5 Stenella attenuata ...... Spotted dolphin ...... 2.29 7 .5 Stenella plagiodon ...... Spotted dolphin ...... 2 .29 7 .5 Steno bredanensis ...... Rough-toothed dolphin ...... 2 .44 8 .0 1 This table contains the species of marine mammals known by the Department to be presently in captivity or that are likely to become captive in the future. Anyone who is subject to the Animal Welfare Act having species of marine mammals in captivity which are not included in this table should consult the Deputy Administrator with regard to the average adult length of such animals.

Average adult length Species Common name In meters In feet Male Female Male Female

Group I Pinnipeds: Arctocephalus gazella** ...... Antarctic Fur Seal ...... 1.80 1 .20 5 .9 3 .9 Arctocephalus tropicalis** ...... Amsterdam Island Fur Seal ...... 1 .80 1 .45 5 .9 4 .75 Arctocephalus australis** ...... South American Fur Seal ...... 1 .88 1 .42 6 .2 4 .7 Arctocephalus pusillis** ...... Cape Fur Seal ...... 2 .73 1 .83 8 .96 6.0 Callorhinus ursinus** ...... Northern Fur Seal ...... 2.20 1 .45 7 .2 4 .75 Eumetopias jubatus** ...... Steller’s Sea Lion ...... 2 .86 2.40 9 .4 7 .9 Hydrurga leptonyx ...... Leopard Seal ...... 2 .90 3 .30 9 .5 10.8 Mirounga angustirostris** ...... Northern Elephant Seal ...... 3 .96 2.49 13 .0 8 .2 Mirounga leonina** ...... Southern Elephant Seal ...... 4.67 2 .50 15 .3 8 .2 Odobenus rosmarus** ...... Walrus ...... 3 .15 2 .60 10.3 8 .5 Otaria flavescens** ...... South American Sea Lion ...... 2 .40 2 .00 7 .9 6 .6 Phoca caspica ...... Caspian Seal ...... 1.45 1 .40 4 .75 4 .6 Phoca fasciata ...... Ribbon Seal ...... 1 .75 1 .68 5 .7 5 .5 Phoca larga ...... Harbor Seal ...... 1 .70 1.50 5 .6 4 .9 Phoca vitulina ...... Habor Seal ...... 1.70 1 .50 5 .6 4 .9 Zalophus californianus ...... California Sea Lion ...... 2 .24 1 .75 7 .3 5 .7 Halichoerus grypus** ...... Grar Seal ...... 2 .30 1 .95 7.5 6.4 Phoca sibirica ...... Baikal Seal ...... 1 .70 1 .85 5 .6 6 .1 Phoca groenlandica ...... Harp Seal ...... 1 .85 1.85 6 .1 6 .1 Leptonychotes weddelli** ...... Weddell Seal ...... 2 .90 3 .15 9 .5 10 .3 Lobodon carcinophagus** ...... Crabeater Seal ...... 2 .21 2 .21 7 .3 7 .3

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Average adult length Species Common name In meters In feet Male Female Male Female

Ommatophoca rossi** ...... Ross Seal ...... 1 .99 2 .13 6 .5 7 .0 Group II Pinnipeds: Erignathus barbatus ...... Bearded Seal ...... 2 .33 2 .33 7.6 7.6 Phoca hispida ...... Ringed Seal ...... 1 .35 1 .30 4.4 4.3 Cystophora cristata ...... Hooded Seal ...... 2 .60 2 .00 8.5 6.6

NOTE. **Any Group I animals maintained together will be considered as Group II when the animals maintained together include two or more sexually mature males from species marked with a double asterisk (**) regardless of whether the sexually mature males from the same species.

Average adult length Species Common name In meters In feet

Sirenia: Dugong dugong ...... Dugong ...... 3 .35 11.0 Trichechus manatus ...... West Indian Manatee ...... 3 .51 11 .5 Trichechus inunguis ...... Amazon Manatee ...... 2 .44 8 .0 Mustelidae: Enhydra lutris ...... Sea Otter ...... 1 .25 4 .1

(2) The minimum depth requirement for as well as the surface area may have to primary enclosure pools for all be adjusted to allow for additional cetaceans shall be one-half the average space necessary for such cetaceans. See adult length of the longest species to Tables I, II, and IV for volumes and be housed therein, regardless of Group surface area requirements. The addi- I or Group II classification, or 1.83 me- tional volume needed shall be based on ters (6.0 feet), whichever is greater, and the number and kind of cetaceans can be expressed as d=L/2 or 6 feet, housed therein and shall be determined whichever is greater. Those parts of in the following manner. the primary enclosure pool which do (i) The minimum volume of water re- not meet the minimum depth require- quired for up to two Group I cetaceans ment cannot be included when calcu- is based upon the following formula: lating space requirements for 2 cetaceans. ⎛ ⎞ = MHD ×× (3) Pool volume. A pool of water hous- Volume ⎝ ⎠ 314. depth ing cetaceans which satisfies the MHD 2 and which meets the minimum depth When there are more than two Group I requirement, will have sufficient vol- cetaceans housed in a primary enclo- ume and surface area to hold up to two sure pool, the additional volume of Group I cetaceans or up to four Group water required for each additional II cetaceans. If additional cetaceans Group I cetacean in excess of two is are to be added to the pool, the volume based on the following formula:

⎛ Average Adult Length⎞ 2 Volume= ××314. depth ⎝ 2 ⎠

See Table I for required volumes. ⎛ ⎞ 2 (ii) The minimum volume of water = MHD ×× required for up to four Group II Volume ⎝ ⎠ 314. depth cetaceans is based upon the following 2 formula:

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When there are more than four Group 2 II cetaceans housed in a primary enclo- ⎛ ⎞ = MHD ×× sure pool, the additional volume of Volume ⎝ ⎠ 314. depth water required for each additional 2 Group II cetacean in excess of four is Then the volume necessary for the based on the following formula: cetaceans to be housed in the pool must be calculated (by obtaining the Volume = (Average Adult Length)2 × × sum of the volumes required for each 3.14 depth animal). If this volume is greater than See Table II for required volumes. that obtained by using the MHD and (iii) When a mixture of both Group I depth figures, then the additional volume required may be added by enlarg- and Group II cetaceans are housed to- ing the pool in its lateral dimensions gether, the MHD must be satisfied as or by increasing its depth, or both. The stated in § 3.104(b)(1), and the minimum minimum surface area requirements depth must be satisfied as stated in discussed next must also be satisfied. § 3.104(b)(2). Based on these figures, the (4)(i) The minimum surface area re- resulting volume must then be cal- quirements for each cetacean housed in culated a pool, regardless of Group I or Group II classification, are calculated as follows:

⎛ average adult body length⎞ 2 Surface Area = ××314.., 15 or: SA = (L/2)2 ×× 314 .. 15 ⎝ 2 ⎠

In a pool containing more than two Group II cetaceans. Pool surfaces Group I cetaceans or more than four where the depth does not meet the Group II cetaceans, 9 the additional minimum requirements cannot be used surface area which may be required in determining the required surface when animals are added must be cal- area. culated for each such animal. (iii) Surface area requirements are (ii) When a mixture of Group I and given in Table IV. Group II cetaceans are to be housed in a pool, the required MHD, depth, and TABLE IV—MINIMUM SURFACE AREA REQUIRED volume must be met. Then the required FOR EACH CETACEAN surface area must be determined for Average adult length of each Surface area required for each animal in the pool. The sum of cetacean each cetacean these surface areas must then be com- Meters Feet Sq. meters 1 Sq. feet pared to the surface area which is obtained by a computation based on the 1.68 5.5 3.31 33.62 10 2.13 7.0 5.36 57.70 required MHD of the pool. The larger 2.29 7.5 6.15 66.23 of the two figures represents the sur- 2.59 8.5 7.90 85.07 face area which is required for a pool 2.74 9.0 8.86 95.38 housing a mixture of Group I and 3.05 10.0 10.94 117.75 3.51 11.5 14.47 155.72 3.66 12.0 15.75 169.56 9 A pool containing up to two Group I 4.27 14.0 21.44 230.79 cetaceans or up to four Group II cetaceans 5.49 18.0 35.44 381.51 which meets the required MHD and depth 5.64 18.5 37.43 403.00 5.79 19.0 39.49 425.08 will have the necessary surface area and vol- 6.71 22.0 52.94 569.91 ume required for the animals contained 6.86 22.5 55.38 596.11 therein. 7.32 24.0 63.01 678.24 10 Since the MHD represents the diameter 8.53 28.0 85.76 923.16 of a circle, the surface area based on the 1 Square meter=square feet/9×0.8361. MHD is calculated by use of the following formula: (c) Sirenians. Primary enclosures SA = π × (MHD / 2)2. housing sirenians shall contain a pool

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of water and may consist entirely of a activity area shall be computed using pool of water. the following methods: (1) The required MHD of a primary (i) Group I pinnipeds. Square the aver- enclosure pool for sirenians shall be age adult length of each pinniped to be two times the average adult length of contained in the primary enclosure. the longest species of sirenian to be Add the figures obtained for each of the housed therein. Calculations shall be pinnipeds in the primary enclosure to based on the average adult length of determine the dry resting or social ac- such sirenians as measured in a hori- tivity area required for such pinnipeds. zontal line from the tip of the muzzle If only a single Group I pinniped is to the notch in the tail fluke of maintained in the primary enclosure, dugongs and from the tip of the muzzle the minimum dry resting or social ac- to the most distal point in the rounded tivity area shall be twice the square of tail of the manatee. the average adult length of that single (2) The minimum depth requirements Group I pinniped. Examples: for primary enclosure pools for all sire- (average adult length)2 of 1st Group I nians shall be one-half the average pinniped+(average adult length)2 of adult length of the longest species to 2nd Group I pinniped=Total DRA be housed therein, or 1.52 meters (5.0 for two pinnipeds feet), whichever is greater. Those parts × of the primary enclosure pool which do DRA for one pinniped=2 (average 2 not meet the minimum depth require- adult length of Group I pinniped) ments cannot be included when calcu- (ii) Group II pinnipeds. List all lating space requirements for sire- pinnipeds contained in a primary en- nians. closure by average adult length in de- (3) A pool which satisfies the required scending order from the longest species MHD and depth shall be adequate for of pinniped to the shortest species of one or two sirenians. Volume and sur- pinniped. Square the average adult face area requirements for additional length of each pinniped. Multiply the animals shall be calculated using the average adult length squared of the same formula as for Group I cetaceans, longest pinniped by 1.5, the second except that the figure for depth re- longest by 1.4, the third longest by 1.3, quirement for sirenians shall be one- the fourth longest by 1.2, and the fifth half the average adult length or 1.52 longest by 1.1, as indicated in the fol- meters (5.0 feet), whichever is greater. lowing example. Square the average (d) Pinnipeds. (1) Primary enclosures adult length of the sixth pinniped and housing pinnipeds shall contain a pool each additional pinniped. Add the fig- of water and a dry resting or social ac- ures obtained for all the pinnipeds in tivity area that must be close enough the primary enclosure to determine the to the surface of the water to allow required minimum dry resting or social easy access for entering or leaving the activity area required for such pool. For the purposes of this subpart, pinnipeds. If only a single Group II pinnipeds have been divided into Group pinniped is maintained in the primary I pinnipeds and Group II pinnipeds as enclosure, the minimum dry resting or shown in Table III in this section. In social activity area must be computed certain instances some Group I for a minimum of two pinnipeds. pinnipeds shall be considered as Group Examples: DRA for 1 Group II Pinniped II pinnipeds. (See Table III). = [(Average adult length)2 × 1.5] + (2) The minimum size of the dry rest- [(Average adult length)2 × 1.4] ing or social activity area of the primary enclosure for pinnipeds (exclusive 1st pinniped (avg. adult length)2×1.5=social and DRA re- of the pool of water) shall be based on quired 2nd pinniped (avg. adult length)2×1.4=social and DRA re- the average adult length of each quired pinniped contained therein, as meas- 3rd pinniped (avg. adult length)1×1.3=social and DRA re- ured in a horizontal or extended posi- quired 2× tion in a straight line from the tip of 4th pinniped (avg. adult length) 1.2=social and DRA required its nose to the tip of its tail. The min- 5th pinniped (avg. adult length)2×1.1=social and DRA re- imum size of the dry resting or social quired

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Each pinniped over 5 (avg. adult length)2=social and DRA (e) Polar bears. Primary enclosures required housing polar bears shall consist of a Total minimum social activity and dry resting area required pool of water, a dry resting and social for all pinnipeds housed in a primary enclosure. activity area, and a den. A minimum of 37.16 square meters (400 square feet) of If all the pinnipeds in the primary en- dry resting and social activity area closure are of the same species, the shall be provided for up to two polar same descending order of calculation bears, with an additional 3.72 square shall apply. Example: Hooded seal—av- meters (40 square feet) of dry resting erage adult length of male=8.5 feet and and social activity area for each addi- female=6.6 feet. In a primary enclosure tional polar bear. The dry resting and containing 2 males and 2 females, the social activity area shall be provided social or DRA required would be the with enough shade to accommodate all sum of [(8.5)2×1.5] + [(8.5)2×1.4] of the polar bears housed in such pri- +[(6.6)2×1.3] + [(6.6)2×1.2]. mary enclosure at the same time. The If two or more sexually mature males pool of water shall have an MHD of not are maintained together in a primary less than 2.44 meters (8.0 feet) and a enclosure, the dry resting or social ac- surface area of at least 8.93 square me- tivity area shall be divided into two or ters (96.0 square feet) with a minimum more separate areas with sufficient vis- depth of 1.52 meters (5.0 feet) with the ual barriers (such as fences, rocks, or exception of any entry and exit area. foliage) to provide relief from aggres- This size pool shall be adequate for two sive animals. polar bears. For each additional bear, (iii) Mixture of Group I and Group II the surface area of the pool must be in- pinnipeds. In a primary enclosure where creased by 3.72 square meters (40 square a mixture of Group I and Group II feet). In measuring this additional sur- pinnipeds is to be housed, the dry rest- face area, parts of the pool which do ing or social activity area shall be cal- not meet minimum depth cannot be culated as for Group II pinnipeds. The considered. The den shall be at least dry resting or social activity area shall 1.83 meters (6 feet) in width and depth be divided into two or more separate and not less than 1.52 meters (5 feet) in areas with sufficient visual barriers height. It will be so positioned that the (such as fences, rocks, or foliage) to viewing public shall not be visible from provide relief from aggressive animals. the interior of the den. A separate den (3)(i) The minimum surface area of a shall be provided for each adult female pool of water for pinnipeds shall be at of breeding age which is permanently least equal to the dry resting or social housed in the same primary enclosure activity area required. with an adult male of breeding age. Fe- (ii) The MHD of the pool shall be at male polar bears in traveling acts or least one and one-half (1.5) times the shows must be provided a den when average adult length of the largest spe- pregnancy has been determined. cies of pinniped to be housed in the en- (f) Sea otters. (1) Primary enclosures closure; except that such MHD meas- for sea otters shall consist of a pool of urement may be reduced by up to 20 water and a dry resting area. The MHD percent if the amount of the reduction of the pool of water for sea otters shall is added to the MHD at the 90-degree be at least three times the average angle. adult length of the sea otter contained (iii) The pool of water shall be at therein (measured in a horizontal line least 0.91 meters (3.0 feet) deep or one- from the tip of its nose to the tip of its half the average adult length of the tail) and the pool shall be not less than longest species of pinniped contained .91 meters (3.0 feet) deep. When more therein, whichever is greater. Parts of than two sea otters are housed in the the pool that do not meet the min- same primary enclosure, additional dry imum depth requirement cannot be resting area as well as pool volume is used in the calculation of the dry rest- required to accommodate the addi- ing and social activity area, or as part tional sea otters. (See Table V). of the MHD or required surface area of (2) The minimum volume of water re- the pool. quired for a primary enclosure pool for 105

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sea otters shall be based on the sea ot- be based on the sea otter’s average ter’s average adult length. The min- adult length. The minimum dry resting imum volume of water required in the area for one or two sea otters shall be pool shall be computed using the fol- computed using the following method: lowing method: Multiply the square of Square the average adult length of the the sea otter’s average adult length by sea otter and multiply the total by 3.14 and then multiply the total by 0.91 3.14. When the enclosure is to contain meters (3.0 feet). This volume is satis- more than two sea otters, the dry rest- factory for one or two otters. To cal- ing area for each additional animal culate the additional volume of water shall be computed by multiplying one- for each additional sea otter above two in a primary enclosure, multiply one- half of the sea otter’s average adult half of the square of the sea otter’s av- length by 3.14. Using 1.25 meters or 4.1 erage adult length by 3.14, then mul- feet (the average adult length of a sea tiply by 0.91 meters (3.0 feet). (See otter), the calculations for additional Table V). space will result in the following fig- (3) The minimum dry resting area re- ures: quired for one or two sea otters shall

TABLE V—ADDITIONAL SPACE REQUIRED FOR EACH SEA OTTER WHEN MORE THAN TWO IN A PRIMARY ENCLOSURE

Average adult length of sea otter Resting area Pool Volume Meters Feet Square meters Square Feet Cubic meters Cubic feet

1.25 4.1 1.96 6.44 2.23 79.17

[44 FR 36874, June 22, 1979, as amended at 45 FR 63261, Sept. 24, 1980; 49 FR 26682, 26685, June 28, 1984; 49 FR 27922, July 9, 1984; 63 FR 2, Jan. 2, 1998; 63 FR 47148, Sept. 4, 1998; 66 FR 252, Jan. 3, 2001]

ANIMAL HEALTH AND HUSBANDRY essary knowledge to assure that each STANDARDS marine mammal receives an adequate quantity of food to maintain it in good § 3.105 Feeding. health. Such employee or attendant is (a) The food for marine mammals required to have the ability to recog- must be wholesome, palatable, and free nize deviations from a normal state of from contamination and must be of good health in each marine mammal so sufficient quantity and nutritive value that the food intake can be adjusted to maintain marine mammals in a accordingly. Inappetence exceeding 24 state of good health. The diet must be hours must be reported immediately to prepared with consideration for factors the attending veterinarian. Public such as age, species, condition, and size feeding may be permitted only in the of the marine mammal being fed. Ma- presence and under the supervision of a rine mammals must be offered food at sufficient number of knowledgeable, least once a day, except as directed by uniformed employees or attendants. the attending veterinarian. Such employees or attendants must as- (b) Food receptacles, if used, must be sure that the marine mammals are re- located so as to be accessible to all ma- ceiving the proper amount and type of rine mammals in the same primary en- food. Only food supplied by the facility closure and must be placed so as to where the marine mammals are kept minimize contamination of the food may be fed to the marine mammals by they contain. Such food receptacles the public. Marine mammal feeding must be cleaned and sanitized after records noting the estimated indi- each use. vidual daily consumption must be (c) Food, when given to each marine maintained at the facility for a period mammal individually, must be given of 1 year and must be made available by an employee or attendant respon- for APHIS inspection. For marine sible to management who has the nec- mammals that are individually fed and

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not subject to public feeding, the feed- chemical additives (e.g. chlorine and ing records should reflect an accurate copper) that are added to the water to account of food intake; for animals fed, maintain water quality standards. Fa- in part, by the public, and for large, cilities using natural seawater shall be group-fed colonies of marine mammals exempt from pH and chemical testing where individual rations are not prac- unless chemicals are added to maintain tical or feasible to maintain, the daily water quality. However, they are re- food consumption should be estimated quired to test for coliforms. Records as precisely as possible. must be kept documenting the time (d) Food preparation and handling when all such samples were taken and must be conducted so as to assure the the results of the sampling. Records of wholesomeness and nutritive value of all such test results shall be main- the food. Frozen fish or other frozen tained by management for a 1-year pe- food must be stored in freezers that are riod and must be made available for in- maintained at a maximum tempera- spection purposes on request. ¥ ° ° ture of 18 C (0 F). The length of (c) Salinity. Primary enclosure pools time food is stored and the method of of water shall be salinized for marine storage, the thawing of frozen food, and cetaceans as well as for those other the maintenance of thawed food must marine mammals which require be conducted in a manner that will salinized water for their good health minimize contamination and that will and well-being. The salinity of the assure that the food retains nutritive value and wholesome quality until the water in such pools shall be maintained time of feeding. When food is thawed in within a range of 15–36 parts per thou- standing or running water, cold water sand. must be used. All foods must be fed to (d) Filtration and water flow. Water the marine mammals within 24 hours quality must be maintained by filtra- following the removal of such foods tion, chemical treatment, or other from the freezers for thawing, or if the means so as to comply with the water food has been thawed under refrigera- quality standards specified in this section, it must be fed to the marine tion. mammals within 24 hours of thawing. § 3.107 Sanitation. [66 FR 252, Jan. 3, 2001] (a) Primary enclosures. (1) Animal and § 3.106 Water quality. food waste in areas other than the pool (a) General. The primary enclosure of water must be removed from the pri- shall not contain water which would be mary enclosures at least daily, and detrimental to the health of the ma- more often when necessary, in order to rine mammal contained therein. provide a clean environment and mini- (b) Bacterial standards. (1) The coli- mize health and disease hazards. form bacteria count of the primary en- (2) Particulate animal and food closure pool shall not exceed 1,000 MPN waste, trash, or debris that enters the (most probable number) per 100 ml. of primary enclosure pools of water must water. Should a coliform bacterial be removed at least daily, or as often count exceed 1,000 MPN, two subse- as necessary, to maintain the required quent samples may be taken at 48-hour water quality and to minimize health intervals and averaged with the first and disease hazards to the marine sample. If such average count does not mammals. fall below 1,000 MPN, then the water in (3) The wall and bottom surfaces of the pool shall be deemed unsatisfac- the primary enclosure pools of water tory, and the condition must be cor- must be cleaned as often as necessary rected immediately. to maintain proper water quality. Nat- (2) When the water is chemically ural organisms (such as algae, treated, the chemicals shall be added coelenterates, or molluscs, for exam- so as not to cause harm or discomfort ple) that do not degrade water quality to the marine mammals. as defined in § 3.106, prevent proper (3) Water samples shall be taken and maintenance, or pose a health or dis- tested at least weekly for coliform ease hazard to the animals are not con- count and at least daily for pH and any sidered contaminants.

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(b) Food preparation. Equipment and for such employees. This training utensils used in food preparation must course will include, but is not limited be cleaned and sanitized after each use. to, species appropriate husbandry tech- Kitchens and other food handling areas niques, animal handling techniques, where animal food is prepared must be and information on proper reporting cleaned at least once daily and sani- protocols, such as recordkeeping and tized at least once every week. Sani- notification of veterinary staff for tizing must be accomplished by wash- medical concerns. ing with hot water (8 °C, 180 °F, or (c) Any training of marine mammals higher) and soap or detergent in a me- must be done by or under the direct su- chanical dishwasher, or by washing all pervision of experienced trainers. soiled surfaces with a detergent solu- (d) Trainers and handlers must meet tion followed by a safe and effective professionally recognized standards for disinfectant, or by cleaning all soiled experience and training. surfaces with live steam. Substances such as cleansing and sanitizing [66 FR 253, Jan. 3, 2001] agents, pesticides, and other poten- § 3.109 Separation. tially toxic agents must be stored in properly labeled containers in secured Marine mammals, whenever known cabinets designed and located to pre- to be primarily social in the wild, must vent contamination of food storage be housed in their primary enclosure preparation surfaces. with at least one compatible animal of (c) Housekeeping. Buildings and the same or biologically related spe- grounds, as well as exhibit areas, must cies, except when the attending veteri- be kept clean and in good repair. narian, in consultation with the hus- Fences must be maintained in good re- bandry/training staff, determines that pair. Primary enclosures housing ma- such housing is not in the best interest rine mammals must not have any loose of the marine mammal’s health or objects or sharp projections and/or well-being. However, marine mammals edges which may cause injury or trau- that are not compatible must not be ma to the marine mammals contained housed in the same enclosure. Marine therein. mammals must not be housed near (d) Pest control. A safe and effective other animals that cause them unrea- program for the control of insects, sonable stress or discomfort or inter- ectoparasites, and avian and mamma- fere with their good health. Animals lian pests must be established and housed separately must have a written maintained. Insecticides or other such plan, approved by the attending veteri- chemical agents must not be applied in narian, developed in consultation with primary enclosures housing marine the husbandry/training staff, that in- mammals except when deemed essen- cludes the justification for the length tial by an attending veterinarian. of time the animal will be kept separated or isolated, information on the [66 FR 253, Jan. 3, 2001] type and frequency of enrichment and § 3.108 Employees or attendants. interaction, if appropriate, and provisions for periodic review of the plan by (a) A sufficient number of adequately the attending veterinarian. Marine trained employees or attendants, re- mammals that are separated for non- sponsible to management and working medical purposes must be held in fa- in concert with the attending veteri- cilities that meet minimum space re- narian, must be utilized to maintain quirements as outlined in § 3.104. the prescribed level of husbandry practices set forth in this subpart. Such [66 FR 253, Jan. 3, 2001] practices must be conducted under the supervision of a marine mammal care- § 3.110 Veterinary care. taker who has demonstrable experience (a) Newly acquired marine mammals in marine mammal husbandry and must be isolated from resident marine care. mammals. Animals with a known med- (b) The facility will provide and doc- ical history must be isolated unless or ument participation in and successful until the newly acquired animals can completion of a facility training course be reasonably determined to be in good

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health by the attending veterinarian. into this holding facility prior to such Animals without a known medical his- cleaning and/or sanitizing procedures. tory must be isolated until it is deter- Any marine mammal exposed to a con- mined that the newly acquired animals tagious animal must be evaluated by are determined to be in good health by the attending veterinarian and mon- the attending veterinarian. Any com- itored and/or isolated for an appro- municable disease condition in a newly priate period of time as determined by acquired marine mammal must be rem- the attending veterinarian. edied before it is placed with resident (d) Individual animal medical records marine mammals, unless, in the judg- must be kept and made available for ment of the attending veterinarian, the APHIS inspection. These medical potential benefits of a resident animal records must include at least the fol- as a companion to the newly acquired lowing information: animal outweigh the risks to the resi- (1) Animal identification/name, a dent animal. physical description, including any (b) Holding facilities must be in place identifying markings, scars, etc., age, and available to meet the needs for iso- and sex; and lation, separation, medical treatment, (2) Physical examination informa- and medical training of marine mam- tion, including but not limited to mals. Marine mammals that are iso- length, weight, physical examination lated or separated for nonmedical pur- results by body system, identification poses must be held in facilities that of all medical and physical problems meet minimum space requirements as with proposed plan of action, all diag- outlined in § 3.104. Holding facilities nostic test results, and documentation used only for medical treatment and of treatment. medical training need not meet the (e) A copy of the individual animal minimum space requirements as out- medical record must accompany any lined in § 3.104. Holding of a marine marine mammal upon its transfer to mammal in a medical treatment or another facility, including contract or medical training enclosure that does satellite facilities. not meet minimum space requirements (f) All marine mammals must be vis- for periods longer than 2 weeks must be ually examined by the attending vet- noted in the animal’s medical record erinarian at least semiannually and and the attending veterinarian must must be physically examined under the provide a justification in the animal’s supervision of and when determined to medical record. If holding in such en- be necessary by the attending veteri- closures for medical treatment and/or narian. All cetaceans and sirenians medical training is to last longer than must be physically examined by the at- 2 weeks, such extension must be justi- tending veterinarian at least annually, fied in writing by the attending veteri- unless APHIS grants an exception from narian on a weekly basis. In natural la- this requirement based on consider- goon or coastal enclosures where isola- ations related to the health and safety tion cannot be accomplished, since of the cetacean or sirenian. These ex- water circulation cannot be controlled aminations must include, but are not or isolated, separation of newly ac- limited to, a hands-on physical exam- quired marine mammals must be ac- ination, hematology and blood chem- complished using separate enclosures istry, and other diagnostic tests as de- situated within the facility to prevent termined by the attending veteri- direct contact and to minimize the risk narian. of potential airborne and water cross- (g)(1) A complete necropsy, including contamination between newly acquired histopathology samples, micro- and resident animals. biological cultures, and other testing (c) Any holding facility used for med- as appropriate, must be conducted by ical purposes that has contained a ma- or under the supervision of the attend- rine mammal with an infectious or ing veterinarian on all marine mam- contagious disease must be cleaned mals that die in captivity. A prelimi- and/or sanitized in a manner prescribed nary necropsy report must be prepared by the attending veterinarian. No by the veterinarian listing all healthy animals may be introduced pathologic lesions observed. The final

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necropsy report must include all gross (a) Space requirements. The primary and histopathological findings, the re- enclosure for SWTD cetaceans shall sults of all laboratory tests performed, contain an interactive area, a buffer and a pathological diagnosis. area, and a sanctuary area. None of (2) Necropsy records will be main- these areas shall be made uninviting to tained at the marine mammal’s home the animals. Movement of cetaceans facility and at the facility at which it into the buffer or sanctuary area shall died, if different, for a period of 3 years not be restricted in any way. Notwith- and must be presented to APHIS in- standing the space requirements set spectors when requested. forth in § 3.104, each of the three areas required for SWTD programs shall [66 FR 253, Jan. 3, 2001] meet the following space requirements: (1) The horizontal dimension for each § 3.111 Swim-with-the-dolphin pro- area must be at least three times the grams. average adult body length of the spe- Swim-with-the-dolphin programs cies of cetacean used in the program; shall comply with the requirements in (2) The minimum surface area re- this section, as well as with all other quired for each area is calculated as applicable requirements of the regula- follows: tions pertaining to marine mammals. (i) Up to two cetaceans:

⎛ 3 × average adult body length (L)⎞ 2 Surface Area ( SA).= × 314 ⎝ 2 ⎠

(ii) Three cetaceans: and humans at all times while within the interactive area. If water clarity ⎛ × ⎞ 2 does not allow these observations, the = 3 L ×× SA ⎝ ⎠ 314. 2 interactive sessions shall be canceled 2 until the required clarity is provided. (iii) Additional SA for each animal in (c) Employees and attendants. Each excess of three: SWTD program shall have, at the minimum, the following personnel, with ⎛ 2 × L⎞ 2 the following minimum backgrounds SA = × 314. (each position shall be held by a sepa- ⎝ 2 ⎠ rate individual, with a sufficient num- (3) The average depth for sea pens, la- ber of attendants to comply with goons, and similar natural enclosures § 3.111(e)(4)): at low tide shall be at least 9 feet. The (1) Licensee or manager—at least one average depth for any manmade enclo- full-time staff member with at least 6 sure or other structure not subject to years experience in a professional or tidal action shall be at least 9 feet. A managerial position dealing with cap- portion of each area may be excluded tive cetaceans; when calculating the average depth, (2) Head trainer/behaviorist—at least but the excluded portion may not be one full-time staff member with at used in calculating whether the inter- least 6 years experience in training active, buffer, and sanctuary area meet cetaceans for SWTD behaviors in the the requirements of paragraphs (a)(1), past 10 years, or an equivalent amount (a)(2), and (a)(4) of this section. of experience involving in-water train- (4) The minimum volume required for ing of cetaceans, who serves as the each animal is calculated as follows: head trainer for the SWTD program; × (3) Trainer/supervising attendant—at Volume = SA 9 least one full-time staff member with (b) Water clarity. Sufficient water at least 3 years training and/or han- clarity shall be maintained so that at- dling experience involving human/ceta- tendants are able to observe cetaceans cean interaction programs;

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(4) Attendant—an adequate number session, to include the telephone and of staff members who are adequately FAX numbers for APHIS, Animal Care, trained in the care, behavior, and for reporting injuries or complaints. training of the program animals. At- Members of the public shall agree, in tendants shall be designated by the writing, to abide by the rules and in- trainer, in consultation with the head structions before being allowed to par- trainer/behaviorist and licensee/man- ticipate in the session. Any participant ager, to conduct and monitor inter- who fails to follow the rules or instruc- active sessions in accordance with tions shall be removed from the session § 3.111(e); and by the facility. (5) Attending veterinarian—at least (6) All interactive sessions shall have one staff or consultant veterinarian at least two attendants or other au- who has at least the equivalent of 2 years full-time experience (4,160 or thorized SWTD personnel (i.e., head more hours) with cetacean medicine trainer/behaviorist or trainer/super- within the past 10 years, and who is li- vising attendant). At least one attend- censed to practice veterinary medicine. ant shall be positioned out of the (d) Program animals. Only cetaceans water. One or more attendants or other that meet the requirements of authorized SWTD personnel may be po- § 3.111(e)(2) and (3) may be used in sitioned in the water. If a facility has SWTD programs. more than two incidents during inter- (e) Handling. (1) Interaction time (i.e., active sessions within a year’s time designated interactive swim sessions) span that have been dangerous or for each cetacean shall not exceed 2 harmful to either a cetacean or a hours per day. Each program cetacean human, APHIS, in consultation with shall have at least one period in each 24 the head trainer/behaviorist, will deter- hours of at least 10 continuous hours mine if changes in attendant positions without public interaction. are needed. (2) All cetaceans used in an inter- (7) All SWTD programs shall limit active session shall be adequately interaction between cetaceans and hu- trained and conditioned in human mans so that the interaction does not interaction so that they respond in the harm the cetaceans, does not remove session to the attendants with appro- the element of choice from the priate behavior for safe interaction. cetaceans by actions such as, but not The head trainer/behaviorist, trainer/ limited to, recalling the animal from supervising attendant, or attendant shall, at all times, control the nature the sanctuary area, and does not elicit and extent of the cetacean interaction unsatisfactory, undesirable, or unsafe with the public during a session, using behaviors from the cetaceans. All the trained responses of the program SWTD programs shall prohibit grasp- animal. ing or holding of the cetacean’s body, (3) All cetaceans used in interactive unless under the direct and explicit in- sessions shall be in good health, includ- struction of an attendant eliciting a ing, but not limited to, not being infec- specific cetacean behavior, and shall tious. Cetaceans undergoing veterinary prevent the chasing or other harass- treatment may be used in interactive ment of the cetaceans. sessions only with the approval of the (8) In cases where cetaceans used in attending veterinarian. an interactive session exhibit unsatis- (4) The ratio of human participants factory, undesirable, or unsafe behav- to cetaceans shall not exceed 3:1. The iors, including, but not limited to, ratio of human participants to attend- charging, biting, mouthing, or sexual ants or other authorized SWTD per- contact with humans, such cetaceans sonnel (i.e., head trainer/behaviorist or shall either be removed from the inter- trainer/supervising attendant) shall active area or the session shall be ter- not exceed 3:1. minated. Written criteria shall be de- (5) Prior to participating in an SWTD veloped by each SWTD program, and interactive session, members of the shall be submitted to and approved by public shall be provided with oral and written rules and instructions for the

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APHIS 11 regarding conditions and pro- (vi) The resume of the licensee and/or cedures for maintaining compliance manager, the head trainer/behaviorist, with paragraph (e)(4) of this section; the trainer/supervising attendant, any for the termination of a session when other attendants, and the attending removal of a cetacean is not possible; veterinarian; and regarding criteria and protocols for (vii) The current behavior patterns handling program animal(s) exhibiting and health of each cetacean, to be as- unsatisfactory, undesirable, or unsafe sessed and submitted by the attending behaviors, including retraining time veterinarian; and techniques, and removal from the (viii) For facilities that employ a program and/or facility, if appropriate. part-time attending veterinarian or The head trainer/behaviorist shall de- consultant arrangements, a written termine when operations will be termi- program of veterinary care (APHIS nated, and when they may resume. In the absence of the head trainer/ form 7002), including protocols and behaviorist, the determination to ter- schedules of professional visits; and minate a session shall be made by the (ix) A detailed description of the trainer/supervising attendant. Only the monitoring program to be used to de- head trainer/behaviorist may deter- tect and identify changes in the behav- mine when a session may be resumed. ior and health of the cetaceans. (f) Recordkeeping. (1) Each facility (2) All SWTD programs shall comply shall provide APHIS 12 with a descrip- in all respects with the regulations and tion of its program at least 30 days standards set forth in parts 2 and 3 of prior to initiation of the program, or in this subchapter. the case of any program in place before (3) Individual animal veterinary September 4, 1998, not later than Octo- records, including all examinations, ber 5, 1998. The description shall in- laboratory reports, treatments, and ne- clude at least the following: cropsy reports shall be kept at the (i) Identification of each cetacean in SWTD site for at least 3 years and shall the program, by means of name and/or be made available to an APHIS official number, sex, age, and any other means upon request during inspection. the Administrator determines to be (4) The following records shall be necessary to adequately identify the kept at the SWTD site for at least 3 cetacean; years and shall be made available to an (ii) A description of the educational APHIS official upon request during in- content and agenda of planned inter- spection: active sessions, and the anticipated av- (i) Individual cetacean feeding erage and maximum frequency and du- records; and ration of encounters per cetacean per day; (ii) Individual cetacean behavioral (iii) The content and method of pre- records. encounter orientation, rules, and in- (5) The following reports shall be structions, including restrictions on kept at the SWTD site for at least 3 types of physical contact with the years and shall be made available to an cetaceans; APHIS official upon request during in- (iv) A description of the SWTD facil- spection: ity, including the primary enclosure (i) Statistical summaries of the num- and other SWTD animal housing or ber of minutes per day that each ani- holding enclosures at the facility; mal participated in an interactive ses- (v) A description of the training, in- sion; cluding actual or expected number of (ii) A statistical summary of the hours each cetacean has undergone or number of human participants per will undergo prior to participation in month in the SWTD program; and the program; (6) A description of any changes made in the SWTD program, which shall be 11 Send to Administrator, c/o Animal and submitted to APHIS 13 on a semi-an- Plant Health Inspection Service, Animal nual basis. Care, 4700 River Road Unit 84, Riverdale, Maryland 20737–1234. 12 See footnote 11 in § 3.111(e)(8). 13 See footnote 11 in § 3.111(e)(8).

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(7) All incidents resulting in injury of each cetacean (i.e., whether in an ac- to either cetaceans or humans partici- tive breeding program, pregnant, or pating in an interactive session, which nursing). shall be reported to APHIS within 24 (5) The attending veterinarian shall hours of the incident. 14 Within 7 days examine water quality records and proof any such incident, a written report vide a written assessment, to remain at shall be submitted to the Adminis- the SWTD site for at least 3 years, of trator. 15 The report shall provide a de- the overall water quality during the tailed description of the incident and preceding month. Such records shall be shall establish a plan of action for the made available to an APHIS official prevention of further occurrences. upon request during inspection. (g) Veterinary care. (1) The attending (6) In the event that a cetacean dies, veterinarian shall conduct on-site eval- complete necropsy results, including uations of each cetacean at least once all appropriate histopathology, shall be a month. The evaluation shall include recorded in the cetacean’s individual a visual inspection of the animal; ex- file and shall be made available to amination of the behavioral, feeding, APHIS officials during facility inspec- and medical records of the animal; and tions, or as requested by APHIS. The a discussion of each animal with an necropsy shall be performed within 48 animal care staff member familiar with hours of the cetacean’s death, by a vet- the animal. erinarian experienced in marine mam- (2) The attending veterinarian shall mal necropsies. If the necropsy is not observe an interactive swim session at to be performed within 3 hours of the the SWTD site at least once each discovery of the cetacean’s death, the month. cetacean shall be refrigerated until ne- (3) The attending veterinarian shall cropsy. Written results of the necropsy conduct a complete physical examina- shall be available in the cetacean’s in- tion of each cetacean at least once dividual file within 7 days after death every 6 months. The examination shall for gross pathology and within 45 days include a profile of the cetacean, in- after death for histopathology. cluding the cetacean’s identification (Approved by the Office of Management and (name and/or number, sex, and age), Budget under control numbers 0579–0036 and weight, 16 length, axillary girth, appe- 0579–0115) tite, and behavior. The attending vet- [63 FR 47148, Sept. 4, 1998] erinarian shall also conduct a general EFFECTIVE DATE NOTE: At 64 FR 15920, Apr. examination to evaluate body condi- 2, 1999, § 3.111 was suspended, effective Apr. 2, tion, skin, eyes, mouth, blow hole and 1999. cardio-respiratory system, genitalia, and feces (gastrointestinal status). The TRANSPORTATION STANDARDS examination shall also include a complete blood count and serum chemistry § 3.112 Consignments to carriers and analysis. Fecal and blow hole smears intermediate handlers. shall be obtained for cytology and (a) Carriers and intermediate han- parasite evaluation. dlers shall not accept any marine (4) The attending veterinarian, dur- mammal that is presented by any dealing the monthly site visit, shall record er, research facility, exhibitor, oper- the nutritional and reproductive status ator of an auction sale, or other person, or any department, agency, or in- 14 Telephone numbers for APHIS, Animal strumentality of the United States or Care, regional offices can be found in local any State or local government for ship- telephone books. ment, in commerce, more than 4 hours 15 See footnote 11 in § 3.111(e)(8). prior to the scheduled departure of the 16 Weight may be measured either by scale primary conveyance on which it is to or calculated using the following formulae: be transported, and that is not accom- ¥ Females: Natural log of body mass = 8.44 panied by a health certificate signed by + 1.34(natural log of girth) + 1.28(natural log of standard length). the attending veterinarian stating that Males: Natural log of body mass= ¥10.3 + the animal was examined within the 1.62(natural log of girth) + 1.38(natural log of prior 10 days and found to be in accept- standard length). able health for transport: Provided,

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however, That the carrier or inter- perature within the range of 7.2 °C (45 mediate handler and any dealer, re- °F) to 23.9 °C (75 °F) allowed by § 3.117 of search facility, exhibitor, operator of this subpart may accept for transpor- an auction sale, or other person, or any tation or transport, in commerce, any department, agency, or instrumen- marine mammal consigned by any de- tality of the United States or any partment, agency, or instrumentality State or local government may mutu- of the United States or of any State or ally agree to extend the time of accept- local government, or by any person (in- ance to not more than 6 hours if spe- cluding any licensee or registrant cific prior scheduling of the animal under the Act, as well as any private shipment to destination has been individual) if the consignor furnishes made. to the carrier or intermediate handler (b) Any carrier or intermediate han- a certificate executed by the attending dler shall only accept for transpor- veterinarian on a specified date that is tation or transport, in commerce, any not more than 10 days prior to delivery marine mammal in a primary trans- of the animal for transportation in port enclosure that conforms to the re- commerce, stating that the marine quirements in § 3.113 of this subpart: mammal is acclimated to a specific air Provided, however, That any carrier or temperature range lower or higher intermediate handler may accept for than those prescribed in §§ 3.117 and transportation or transport, in com- 3.118. A copy of the certificate must ac- merce, any marine mammal consigned company the shipment to destination. by any department, agency, or instru- The certificate must include at least mentality of the United States having the following information: laboratory animal facilities or exhib- (1) Name and address of the con- iting animals or any licensed or reg- signor; istered dealer, research facility, exhibi- (2) The number, age, and sex of ani- tor, or operator of an auction sale if mals in the shipment; the consignor furnishes to the carrier (3) A certifying statement (e.g., ‘‘I or intermediate handler a certificate, hereby certify that the animal(s) in signed by the consignor, stating that this shipment is (are), to the best of the primary transport enclosure com- my knowledge, acclimated to an air plies with § 3.113 of this subpart, unless temperature range of llll’’); and such primary transport enclosure is ob- (4) The signature of the attending viously defective or damaged and it is veterinarian and the date. apparent that it cannot reasonably be (d) Carriers and intermediate han- expected to contain the marine mam- dlers must attempt to notify the con- mal without causing suffering or injury signee (receiving party) at least once to the marine mammal. A copy of any in every 6-hour period following the ar- such certificate must accompany the rival of any marine mammals at the shipment to destination. The certifi- animal holding area of the terminal cate must include at least the fol- cargo facility. The time, date, and lowing information: method of each attempted notification (1) Name and address of the con- and the final notification to the consignor; signee and the name of the person noti- (2) The number, age, and sex of ani- fying the consignee must be recorded mals in the primary transport enclo- on the copy of the shipping document sure(s); retained by the carrier or intermediate (3) A certifying statement (e.g., ‘‘I handler and on a copy of the shipping hereby certify that the—(number) pri- document accompanying the animal mary transport enclosure(s) that are shipment. used to transport the animal(s) in this [66 FR 254, Jan. 3, 2001] shipment complies (comply) with USDA standards for primary transport § 3.113 Primary enclosures used to enclosures (9 CFR part 3).’’); and transport marine mammals. (4) The signature of the consignor, No dealer, research facility, exhibi- and date. tor, or operator of an auction sale shall (c) Carriers or intermediate handlers offer for transportation or transport, in whose facilities fail to maintain a tem- commerce, any marine mammal in a

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primary enclosure that does not con- (b) Straps, slings, harnesses, or other form to the following requirements: devices used for body support or re- (a) Primary enclosures that are used straint, when transporting marine to transport marine mammals other mammals such as cetaceans and sire- than cetaceans and sirenians must: nians must: (1) Be constructed from materials of (1) Be designed so as not to prevent sufficient structural strength to con- access to the marine mammals by attain the marine mammals; tendants for the purpose of admin- (2) Be constructed from material that istering in-transit care; is durable, nontoxic, and cannot be (2) Be equipped with special padding chewed and/or swallowed; to prevent trauma or injury at critical (3) Be able to withstand the normal weight pressure points on the body of rigors of transportation; the marine mammals; and (4) Have interiors that are free from (3) Be capable of keeping the animals any protrusions or hazardous openings from thrashing about and causing in- that could be injurious to the marine jury to themselves or their attendants, mammals contained within; and yet be adequately designed so as (5) Be constructed so that no parts of not to cause injury to the animals. the contained marine mammals are ex- (c) Primary enclosures used to trans- posed to the outside of the enclosures port marine mammals must be large in any way that may cause injury to enough to assure that: the animals or to persons who are nearby or who handle the enclosures; (1) In the case of pinnipeds, polar (6) Have openings that provide access bears, and sea otters, each animal has into the enclosures and are secured sufficient space to turn about freely in with locking devices of a type that can- a stance whereby all four feet or flip- not be accidentally opened; pers are on the floor and the animal (7) Have such openings located in a can sit in an upright position and lie in manner that makes them easily acces- a natural position; sible at all times for emergency re- (2) In the case of cetaceans and sire- moval and potential treatment of any nians, each animal has sufficient space live marine mammal contained within; for support of its body in slings, har- (8) Have air inlets at heights that nesses, or other supporting devices, if will provide cross ventilation at all used (as prescribed in paragraph (b) of levels (particularly when the marine this section), without causing injury to mammals are in a prone position), are such cetaceans or sirenians due to con- located on all four sides of the enclo- tact with the primary transport enclosures, and cover not less than 20 per- sure: Provided, however, That animals cent of the total surface area of each may be restricted in their movements side of the enclosures; according to professionally accepted (9) Have projecting rims or other de- standards when such freedom of move- vices placed on any ends and sides of ment would constitute a danger to the the enclosures that have ventilation animals, their handlers, or other per- openings so that there is a minimum sons. air circulation space of 7.6 centimeters (d) Marine mammals transported in (3.0 inches) between the enclosures and the same primary enclosure must be of any adjacent cargo or conveyance wall; the same species and maintained in (10) Be constructed so as to provide compatible groups. Marine mammals sufficient air circulation space to that have not reached puberty may not maintain the temperature limits set be transported in the same primary en- forth in this subpart; and closure with adult marine mammals (11) Be equipped with adequate other than their dams. Socially de- handholds or other devices on the exte- pendent animals (e.g., sibling, dam, and rior of the enclosures to enable them to other members of a family group) must be lifted without unnecessary tilting be allowed visual and olfactory contact and to ensure that the persons han- whenever reasonable. Female marine dling the enclosures will not come in mammals may not be transported in contact with any marine mammal con- the same primary enclosure with any tained inside. mature male marine mammals.

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(e) Primary enclosures used to trans- ture for the species involved and to port marine mammals as provided in provide for the safety and comfort of this section must have solid bottoms to the marine mammal, or other appro- prevent leakage in shipment and must priate safeguards (such as, but not lim- be cleaned and sanitized in a manner ited to, cooling the animal with cold prescribed in § 3.107 of this subpart, if water, adding ice to water-filled enclo- previously used. Within the primary sures, and use of fans) must be em- enclosures used to transport marine ployed to maintain the animal at an mammals, the animals will be main- appropriate temperature. tained on sturdy, rigid, solid floors (b) The animal cargo space must be with adequate drainage. constructed and maintained in a man- (f) Primary enclosures used to trans- ner that will prevent the ingress of en- port marine mammals, except where gine exhaust fumes and gases in excess such primary enclosures are perma- of that ordinarily contained in the pas- nently affixed in the animal cargo senger compartments. space of the primary conveyance, must (c) Marine mammals must only be be clearly marked on top (when placed in animal cargo spaces that present) and on at least one side, or on have a supply of air sufficient for each all sides whenever possible, with the live animal contained within. Primary words ‘‘Live Animal’’ or ‘‘Wild Ani- transport enclosures must be posi- mal’’ in letters not less than 2.5 centi- tioned in the animal cargo spaces of meters (1 inch) in height, and with ar- primary conveyances in such a manner rows or other markings to indicate the that each marine mammal contained correct upright position of the con- within will have access to sufficient tainer. air. (g) Documents accompanying the (d) Primary transport enclosures shipment must be attached in an easily must be positioned in primary convey- accessible manner to the outside of a ances in such a manner that, in an primary enclosure that is part of such emergency, the live marine mammals shipment or be in the possession of the can be removed from the conveyances shipping attendant. as soon as possible. (h) When a primary transport enclo- (e) The interiors of animal cargo sure is permanently affixed within the spaces in primary conveyances must be animal cargo space of the primary con- kept clean. veyance so that the front opening is (f) Live marine mammals must not the only source of ventilation for such knowingly be transported with any ma- primary enclosure, the front opening terial, substance, or device that may be must open directly to the outside or to injurious to the health and well-being an unobstructed aisle or passageway of the marine mammals unless proper within the primary conveyance. Such precaution is taken to prevent such in- front ventilation opening must be at jury. least 90 percent of the total surface (g) Adequate lighting must be avail- area of the front wall of the primary able for marine mammal attendants to enclosure and covered with bars, wire properly inspect the animals at any mesh, or smooth expanded metal. time. If such lighting is not provided by the carrier, provisions must be [66 FR 255, Jan. 3, 2001] made by the shipper to supply such § 3.114 Primary conveyances (motor lighting. vehicle, rail, air and marine). [66 FR 255, Jan. 3, 2001] (a) The animal cargo space of primary conveyances used in transporting § 3.115 Food and drinking water re- live marine mammals must be con- quirements. structed in a manner that will protect (a) Those marine mammals that re- the health and assure the safety and quire drinking water must be offered comfort of the marine mammals con- potable water within 4 hours of being tained within at all times. All primary placed in the primary transport enclo- conveyances used must be sufficiently sure for transport in commerce. Marine temperature-controlled to provide an mammals must be provided water as appropriate environmental tempera- often as necessary and appropriate for

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the species involved to prevent dehy- (c) Carriers must inform the crew as dration, which would jeopardize the to the presence of the marine mam- good health and well-being of the animals on board the craft, inform the in- mals. dividual accompanying the marine (b) Marine mammals being trans- mammals of any unexpected delays as ported in commerce must be offered soon as they become known, and ac- food as often as necessary and appro- commodate, except as precluded by priate for the species involved or as de- safety considerations, requests by the termined by the attending veteri- shipper or his agent to provide access narian. to the animals or take other necessary actions for the welfare of the animals if [66 FR 256, Jan. 3, 2001] a delay occurs. § 3.116 Care in transit. (d) A sufficient number of employees or attendants of the shipper or receiver (a) A licensed veterinarian, em- of cetaceans or sirenians being trans- ployee, and/or attendant of the shipper ported, in commerce, must provide for or receiver of any marine mammal such cetaceans and sirenians during pe- being transported, in commerce, riods of transport by: knowledgeable and experienced in the (1) Keeping the skin moist or pre- area of marine mammal care and trans- venting the drying of the skin by such port, must accompany all marine methods as intermittent spraying of mammals during periods of transpor- water or application of a nontoxic tation to provide for their good health emollient; and well-being, to observe such marine (2) Assuring that the pectoral flippers mammals to determine whether they are allowed freedom of movement at need veterinary care, and to obtain any all times; needed veterinary care as soon as pos- (3) Making adjustments in the posi- sible. Any transport of greater than 2 tion of the marine mammals when nec- hours duration requires a transport essary to prevent necrosis of the skin plan approved by the attending veteri- at weight pressure points; narian that will include the specifica- (4) Keeping the animal cooled and/or tion of the necessity of the presence of warmed sufficiently to prevent over- a veterinarian during the transport. If heating, hypothermia, or temperature the attending veterinarian does not ac- related stress; and company the animal, communication (5) Calming the marine mammals to with the veterinarian must be main- avoid struggling, thrashing, and other tained in accordance with § § 2.33(b)(3) unnecessary activity that may cause and 2.40(b)(3) of this chapter. overheating or physical trauma. (b) The following marine mammals (e) A sufficient number of employees may be transported in commerce only or attendants of the shipper or receiver when the transport of such marine of pinnipeds or polar bears being trans- mammals has been determined to be ported, in commerce, must provide for appropriate by the attending veteri- such pinnipeds and polar bears during narian: periods of transport by: (1) A pregnant animal in the last half (1) Keeping the animal cooled and/or of pregnancy; warmed sufficiently to prevent over- (2) A dependent unweaned young ani- heating, hypothermia, or temperature mal; related stress; and (3) A nursing mother with young; or (2) Calming the marine mammals to (4) An animal with a medical condi- avoid struggling, thrashing, and other tion requiring veterinary care, that unnecessary activity that may cause would be compromised by transport. overheating or physical trauma. The attending veterinarian must note (f) Sea otters must be transported in on the accompanying health certificate primary enclosures that contain false the existence of any of the above condi- floors through which water and waste tions. The attending veterinarian must freely pass to keep the interior of the also determine whether a veterinarian transport unit free from waste mate- should accompany such marine mam- rials. Moisture must be provided by mals during transport. water sprayers or ice during transport.

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(g) Marine mammals may be removed closure not to exceed 0.91 meters (3 from their primary transport enclo- feet). sures only by the attendants or other [66 FR 256, Jan. 3, 2001] persons capable of handling such mammals safely. § 3.118 Handling. [66 FR 256, Jan. 3, 2001] (a) Carriers and intermediate handlers moving marine mammals from § 3.117 Terminal facilities. the animal holding area of the ter- Carriers and intermediate handlers minal facility to the primary convey- must not commingle marine mammal ance or from the primary conveyance shipments with inanimate cargo. All to the animal holding area of the ter- animal holding areas of a terminal fa- minal facility must provide the fol- cility of any carrier or intermediate lowing: handler where marine mammal ship- (1) Movement of animals as expedi- ments are maintained must be cleaned tiously as possible. and sanitized in a manner prescribed in (2) Shelter from overheating and direct § 3.107 of this subpart to minimize sunlight. When sunlight is likely to health and disease hazards. An effec- cause overheating, sunburn, or discom- tive program for the control of insects, fort, sufficient shade must be provided ectoparasites, and avian and mamma- to protect the marine mammals. Ma- lian pests must be established and rine mammals must not be subjected to maintained for all animal holding surrounding air temperatures that ex- areas. Any animal holding area con- ceed 23.9 °C (75 °F) unless accompanied taining marine mammals must be ven- by an acclimation certificate in ac- tilated with fresh air or air circulated cordance with § 3.112 of this subpart. by means of fans, blowers, or an air The temperature must be measured conditioning system so as to minimize and read within or immediately adja- drafts, odors, and moisture condensa- cent to the primary transport enclo- tion. Auxiliary ventilation, such as ex- sure. haust fans and vents or fans or blowers (3) Shelter from cold weather. Marine or air conditioning must be used for mammals must be provided with spe- any animal holding area containing cies appropriate protection against marine mammals when the air tem- cold weather, and such marine mam- perature within such animal holding mals must not be subjected to sur- area is 23.9 °C (75 °F) or higher. The air rounding air temperatures that fall temperature around any marine mam- below 7.2 °C (45 °F) unless accompanied mal in any animal holding area must by an acclimation certificate in ac- not be allowed to fall below 7.2 °C (45 cordance with § 3.112 of this subpart. °F). The air temperature around any The temperature must be measured polar bear must not be allowed to ex- and read within or immediately adja- ceed 29.5 °C (85 °F) at any time and no cent to the primary transport enclo- polar bear may be subjected to sur- sure. rounding air temperatures that exceed (b) Care must be exercised to avoid 23.9 °C (75 °F) for more than 4 hours at handling of the primary transport en- any time. The ambient temperature closure in a manner that may cause must be measured in the animal hold- physical harm or distress to the marine ing area upon arrival of the shipment mammal contained within. by the attendant, carrier, or inter- (c) Enclosures used to transport any mediate handler. The ambient tem- marine mammal must not be tossed, perature must be measured halfway up dropped, or needlessly tilted and must the outside of the primary transport not be stacked unless properly secured. enclosure at a distance from the external wall of the primary transport en- [66 FR 257, Jan. 3, 2001]

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Subpart F—Specifications for the § 3.126 Facilities, indoor. Humane Handling, Care, (a) Ambient temperatures. Tempera- Treatment, and Transportation ture in indoor housing facilities shall of Warmblooded Animals be sufficiently regulated by heating or Other Than Dogs, Cats, Rab- cooling to protect the animals from the bits, Hamsters, Guinea Pigs, extremes of temperature, to provide for Nonhuman Primates, and Ma- their health and to prevent their discomfort. The ambient temperature rine Mammals shall not be allowed to fall below nor rise above temperatures compatible SOURCE: 36 FR 24925, Dec. 24, 1971, unless with the health and comfort of the ani- otherwise noted. Redesignated at 44 FR 36874, mal. July 22, 1979. (b) Ventilation. Indoor housing facili- FACILITIES AND OPERATING STANDARDS ties shall be adequately ventilated by natural or mechanical means to pro- § 3.125 Facilities, general. vide for the health and to prevent dis- (a) Structural strength. The facility comfort of the animals at all times. must be constructed of such material Such facilities shall be provided with and of such strength as appropriate for fresh air either by means of windows, the animals involved. The indoor and doors, vents, fans, or air-conditioning outdoor housing facilities shall be and shall be ventilated so as to mini- structurally sound and shall be main- mize drafts, odors, and moisture contained in good repair to protect the densation. animals from injury and to contain the (c) Lighting. Indoor housing facilities animals. shall have ample lighting, by natural (b) Water and power. Reliable and ade- or artificial means, or both, of good quate electric power, if required to quality, distribution, and duration as comply with other provisions of this appropriate for the species involved. subpart, and adequate potable water Such lighting shall be uniformly dis- shall be available on the premises. tributed and of sufficient intensity to (c) Storage. Supplies of food and bed- permit routine inspection and cleaning. ding shall be stored in facilities which Lighting of primary enclosures shall be adequately protect such supplies designed to protect the animals from against deterioration, molding, or con- excessive illumination. tamination by vermin. Refrigeration (d) Drainage. A suitable sanitary shall be provided for supplies of perish- method shall be provided to eliminate able food. rapidly, excess water from indoor hous- (d) Waste disposal. Provision shall be ing facilities. If drains are used, they made for the removal and disposal of shall be properly constructed and kept animal and food wastes, bedding, dead in good repair to avoid foul odors and animals, trash and debris. Disposal fa- installed so as to prevent any backup cilities shall be so provided and oper- of sewage. The method of drainage ated as to minimize vermin infesta- shall comply with applicable Federal, tion, odors, and disease hazards. The State, and local laws and regulations disposal facilities and any disposal of relating to pollution control or the animal and food wastes, bedding, dead protection of the environment. animals, trash, and debris shall comply with applicable Federal, State, and § 3.127 Facilities, outdoor. local laws and regulations relating to (a) Shelter from sunlight. When sun- pollution control or the protection of light is likely to cause overheating or the environment. discomfort of the animals, sufficient (e) Washroom and sinks. Facilities, shade by natural or artificial means such as washrooms, basins, showers, or shall be provided to allow all animals sinks, shall be provided to maintain kept outdoors to protect themselves cleanliness among animal caretakers. from direct sunlight. [36 FR 24925, Dec. 24, 1971. Redesignated at 44 (b) Shelter from inclement weather. FR 36874, June 22, 1979, and amended at 44 FR Natural or artificial shelter appro- 63492, Nov. 2, 1979] priate to the local climatic conditions

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for the species concerned shall be pro- mals and unauthorized persons and the vided for all animals kept outdoors to Administrator gives written approval; afford them protection and to prevent or discomfort to such animals. Individual (3) Where appropriate alternative se- animals shall be acclimated before curity measures are employed and the they are exposed to the extremes of the Administrator gives written approval; individual climate. or (c) Drainage. A suitable method shall (4) For traveling facilities where ap- be provided to rapidly eliminate excess propriate alternative security meas- water. The method of drainage shall ures are employed; or comply with applicable Federal, State, (5) Where the outdoor housing facil- and local laws and regulations relating ity houses only farm animals, such as, to pollution control or the protection but not limited to, cows, sheep, goats, of the environment. pigs, horses (for regulated purposes), or (d) Perimeter fence. On or after May donkeys, and the facility has in place 17, 2000, all outdoor housing facilities effective and customary containment (i.e., facilities not entirely indoors) and security measures. must be enclosed by a perimeter fence [36 FR 24925, Dec. 24, 1971. Redesignated at 44 that is of sufficient height to keep ani- FR 36874, July 22, 1979, as amended at 64 FR mals and unauthorized persons out. 56147, Oct. 18, 1999; 65 FR 70770, Nov. 28, 2000] Fences less than 8 feet high for potentially dangerous animals, such as, but § 3.128 Space requirements. not limited to, large felines (e.g., lions, Enclosures shall be constructed and tigers, leopards, cougars, etc.), bears, maintained so as to provide sufficient wolves, rhinoceros, and elephants, or space to allow each animal to make less than 6 feet high for other animals normal postural and social adjust- must be approved in writing by the Ad- ments with adequate freedom of move- ministrator. The fence must be con- ment. Inadequate space may be indi- structed so that it protects the animals cated by evidence of malnutrition, poor in the facility by restricting animals condition, debility, stress, or abnormal and unauthorized persons from going behavior patterns. through it or under it and having contact with the animals in the facility, ANIMAL HEALTH AND HUSBANDRY and so that it can function as a sec- STANDARDS ondary containment system for the animals in the facility. It must be of § 3.129 Feeding. sufficient distance from the outside of (a) The food shall be wholesome, pal- the primary enclosure to prevent phys- atable, and free from contamination ical contact between animals inside and of sufficient quantity and nutritive the enclosure and animals or persons value to maintain all animals in good outside the perimeter fence. Such health. The diet shall be prepared with fences less than 3 feet in distance from consideration for the age, species, con- the primary enclosure must be ap- dition, size, and type of the animal. proved in writing by the Adminis- Animals shall be fed at least once a day trator. A perimeter fence is not re- except as dictated by hibernation, vet- quired: erinary treatment, normal fasts, or (1) Where the outside walls of the pri- other professionally accepted prac- mary enclosure are made of sturdy, du- tices. rable material, which may include cer- (b) Food, and food receptacles, if tain types of concrete, wood, plastic, used, shall be sufficient in quantity metal, or glass, and are high enough and located so as to be accessible to all and constructed in a manner that re- animals in the enclosure and shall be stricts entry by animals and unauthor- placed so as to minimize contamina- ized persons and the Administrator tion. Food receptacles shall be kept gives written approval; or clean and sanitary at all times. If self- (2) Where the outdoor housing facil- feeders are used, adequate measures ity is protected by an effective natural shall be taken to prevent molding, con- barrier that restricts the animals to tamination, and deterioration or cak- the facility and restricts entry by ani- ing of food.

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§ 3.130 Watering. in this subpart. Such practices shall be If potable water is not accessible to under a supervisor who has a back- the animals at all times, it must be ground in animal care. provided as often as necessary for the § 3.133 Separation. health and comfort of the animal. Fre- quency of watering shall consider age, Animals housed in the same primary species, condition, size, and type of the enclosure must be compatible. Animals animal. All water receptacles shall be shall not be housed near animals that kept clean and sanitary. interfere with their health or cause them discomfort. § 3.131 Sanitation. §§ 3.134–3.135 [Reserved] (a) Cleaning of enclosures. Excreta shall be removed from primary enclo- TRANSPORTATION STANDARDS sures as often as necessary to prevent contamination of the animals con- SOURCE: Sections 3.136 through 3.142 appear tained therein and to minimize disease at 42 FR 31569, June 21, 1977, unless otherwise hazards and to reduce odors. When en- noted. Redesignated at 44 FR 36874, July 22, closures are cleaned by hosing or flush- 1979. ing, adequate measures shall be taken to protect the animals confined in such § 3.136 Consignments to carriers and intermediate handlers. enclosures from being directly sprayed with the stream of water or wetted in- (a) Carriers and intermediate han- voluntarily. dlers shall not accept any live animals (b) Sanitation of enclosures. Subse- presented by any dealer, research facil- quent to the presence of an animal ity, exhibitor, operator of an auction with an infectious or transmissible dis- sale, or other person, or any depart- ease, cages, rooms, and hard-surfaced ment, agency, or instrumentality of pens or runs shall be sanitized either the United States or any State or local by washing them with hot water (180 F. government for shipment, in com- at source) and soap or detergent, as in merce, more than 4 hours prior to the a mechanical washer, or by washing all scheduled departure of the primary soiled surfaces with a detergent solu- conveyance on which it is to be trans- tion followed by a safe and effective ported: Provided, however, That the car- disinfectant, or by cleaning all soiled rier or intermediate handler and any surfaces with saturated live steam dealer, research facility, exhibitor, op- under pressure. Pens or runs using erator of an auction sale, or other per- gravel, sand, or dirt, shall be sanitized son, or any department, agency, or in- when necessary as directed by the at- strumentality of the United States or tending veterinarian. any State or local government may (c) Housekeeping. Premises (buildings mutually agree to extend the time of and grounds) shall be kept clean and in acceptance to not more than 6 hours if good repair in order to protect the ani- specific prior scheduling of the animal mals from injury and to facilitate the shipment to destination has been prescribed husbandry practices set made. forth in this subpart. Accumulations of (b) Any carrier or intermediate han- trash shall be placed in designated dler shall only accept for transpor- areas and cleared as necessary to pro- tation or transport, in commerce, any tect the health of the animals. live animal in a primary enclosure (d) Pest control. A safe and effective which conforms to the requirements program for the control of insects, set forth in § 3.137 of the standards: Pro- ectoparasites, and avian and mamma- vided, however, That any carrier or in- lian pests shall be established and termediate handler may accept for maintained. transportation or transport, in commerce, any live animal consigned by § 3.132 Employees. any department, agency, or instrumen- A sufficient number of adequately tality of the United States having lab- trained employees shall be utilized to oratory animal facilities or exhibiting maintain the professionally acceptable animals or any licensed or registered level of husbandry practices set forth dealer, research facility, exhibitor, or

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operator of an auction sale if the con- (3) A certifying statement (e.g., ‘‘I signor furnishes to the carrier or inter- hereby certify that the animal(s) in mediate handler a certificate, signed this shipment is (are), to the best of by the consignor, stating that the pri- my knowledge, acclimated to air tem- mary enclosure complies with § 3.137 of peratures lower than 7.2 °C. (45 °F.)’’); the standards, unless such primary en- and closure is obviously defective or dam- (4) The signature of the USDA ac- aged and it is apparent that it cannot credited veterinarian, assigned reasonably be expected to contain the accrediation number, and date. live animal without causing suffering (d) Carriers and intermediate han- or injury to such live animal. A copy of dlers shall attempt to notify the con- such certificate shall accompany the signee at least once in every 6 hour pe- shipment to destination. The certifi- riod following the arrival of any live cate shall include at least the fol- animals at the animal holding area of lowing information: the terminal cargo facility. The time, (1) Name and address of the con- date, and method of each attempted signor; notification and the final notification (2) The number of animals in the pri- to the consignee and the name of the mary enclosure(s); person notifying the consignee shall be recorded on the copy of the shipping (3) A certifying statement (e.g., ‘‘I document retained by the carrier or in- hereby certify that the ll (number) termediate handler and on a copy of primary enclosure(s) which are used to the shipping document accompanying transport the animal(s) in this ship- the animal shipment. ment complies (comply) with USDA standards for primary enclosures (9 [42 FR 31569, June 21, 1977, as amended at 43 CFR part 3).’’); and FR 21166, May 16, 1978. Redesignated at 44 FR (4) The signature of the consignor, 36874, July 22, 1979, and amended at 44 FR 63493, Nov. 2, 1979] and date. (c) Carriers or intermediate handlers § 3.137 Primary enclosures used to whose facilities fail to meet the min- transport live animals. imum temperature allowed by the No dealer, research facility, exhibi- standards may accept for transpor- tor, or operator of an auction sale shall tation or transport, in commerce, any offer for transportation or transport, in live animal consigned by any depart- commerce, any live animal in a pri- ment, agency, or instrumentality of mary enclosure which does not con- the United States or of any State or form to the following requirements: local government, or by any person (in- (a) Primary enclosures, such as com- cluding any licensee or registrant partments, transport cages, cartons, or under the Act, as well as any private crates, used to transport live animals individual) if the consignor furnishes shall be constructed in such a manner to the carrier or intermediate handler that (1) the structural strength of the a certificate executed by a veterinarian enclosure shall be sufficient to contain accredited by this Department pursu- the live animals and to withstand the ant to part 160 of this title on a speci- normal rigors of transportation; (2) the fied date which shall not be more than interior of the enclosure shall be free 10 days prior to delivery of such animal from any protrusions that could be infor transportation in commerce, stat- jurious to the live animals contained ing that such live animal is acclimated therein; (3) the opernings of such enclo- to air temperatures lower than those sures are easily accessible at all times prescribed in §§ 3.141 and 3.142. A copy for emergency removal of the live ani- of such certificate shall accompany the mals; (4) except as provided in para- shipment to destination. The certifi- graph (g) of this section, there are ven- cate shall include at least the fol- tilation openings located on two oppo- lowing information: site walls of the primary enclosure and (1) Name and address of the con- the ventilation openings on each such signor; wall shall be at least 16 percent of the (2) The number of animals in the total surface area of each such wall, or shipment; there are ventilation openings located

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on all four walls of the primary enclo- (d) Primary enclosures used to trans- sure and the ventilation openings on port live animals as provided in this each such wall shall be at least 8 per- section shall have solid bottoms to pre- cent of the total surface area of each vent leakage in shipment and still be such wall: Provided, however, That at cleaned and sanitized in a manner pre- least one-third of the total minimum scribed in § 3.131 of the standards, if area required for ventilation of the pri- previously used. Such primary enclo- mary enclosure shall be located on the sures shall contain clean litter of a lower one-half of the primary enclosure suitable absorbant material, which is and at least one-third of the total min- safe and nontoxic to the live animals imum area required for ventilation of contained therein, in sufficient quan- the primary enclosure shall be located tity to absorb and cover excreta, unless on the upper one-half of the primary the animals are on wire or other enclosure; (5) except as provided in nonsolid floors. paragraph (g) of this section, pro- (e) Primary enclosures used to trans- jecting rims or other devices shall be port live animals, except where such on the exterior of the outside walls primary enclosures are permanently af- with any ventilation openings to pre- fixed in the animal cargo space of the vent obstruction of the ventilation primary conveyance, shall be clearly openings and to provide a minimum air marked on top and on one or more circulation space of 1.9 centimeters (.75 sides with the words ‘‘Live Animal’’ or inch) between the primary enclosure ‘‘Wild Animal’’, whichever is appro- and any adjacent cargo or conveyance priate, in letters not less than 2.5 cen- wall; and (6) except as provided in para- timeters (1 inch) in height, and with graph (g) of this section, adequate arrows or other markings to indicate handholds or other devices for lifting the correct upright position of the con- shall be provided on the exterior of the tainer. primary enclosure to enable the pri- (f) Documents accompanying the mary enclosure to be lifted without shipment shall be attached in an easily tilting and to ensure that the person accessible manner to the outside of a handling the primary enclosure will primary enclosure which is part of such not be in contact with the animal. shipment. (b) Live animals transported in the (g) When a primary enclosure is per- same primary enclosure shall be of the manently affixed within the animal same species and maintained in com- cargo space of the primary conveyance patible groups. Live animals that have so that the front opening is the only not reached puberty shall not be trans- source of ventilation for such primary ported in the same primary enclosure enclosure, the front opening shall open with adult animals other than their directly to the outside or to an unob- dams. Socially dependent animals (e.g., structed aisle or passageway within the sibling, dam, and other members of a primary conveyance. Such front ven- family group) must be allowed visual tilation opening shall be at least 90 and olfactory contact. Any female ani- percent of the total surface area of the mal in season (estrus) shall not be front wall of the primary enclosure and transported in the same primary enclo- covered with bars, wire mesh or sure with any male animal. smooth expanded metal. (c) Primary enclosures used to trans- [42 FR 31569, June 21, 1977, as amended at 43 port live animals shall be large enough FR 21166, May 16, 1978. Redesignated at 44 FR to ensure that each animal contained 36874, July 22, 1979] therein has sufficient space to turn about freely and to make normal pos- § 3.138 Primary conveyances (motor tural adjustments: Provided, however, vehicle, rail, air, and marine). That certain species may be restricted (a) The animal cargo space of pri- in their movements according to pro- mary conveyances used in transporting fessionally acceptable standards when live animals shall be designed and con- such freedom of movement would constructed to protect the health, and en- stitute a danger to the animals, their sure the safety and comfort of the live handlers, or other persons. animals contained therein at all times.

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(b) The animal cargo space shall be accepted practice, require feeding more constructed and maintained in a man- frequently shall be so fed. ner to prevent the ingress of engine ex- (c) A sufficient quantity of food and haust fumes and gases from the pri- water shall accompany the live animal mary conveyance during transpor- to provide food and water for such ani- tation in commerce. mals for a period of at least 24 hours, (c) No live animal shall be placed in except as directed by hibernation, vet- an animal cargo space that does not erinary treatment, normal fasts, and have a supply of air sufficient for nor- other professionally accepted prac- mal breathing for each live animal con- tices. tained therein, and the primary enclo- (d) Any dealer, research facility, ex- sures shall be positioned in the animal hibitor or operator of an auction sale cargo space in such a manner that each offering any live animal to any carrier live animal has access to sufficient air or intermediate handler for transpor- for normal breathing. tation in commerce shall affix to the (d) Primary enclosures shall be posi- outside of the primary enclosure used tioned in the primary conveyance in for transporting such live animal, writ- such a manner that in an emergency ten instructions concerning the food the live animals can be removed from and water requirements of such animal the primary conveyance as soon as pos- while being so transported. sible. (e) No carrier or intermediate handler shall accept any live animals for (e) The interior of the animal cargo transportation in commerce unless space shall be kept clean. written instructions concerning the (f) Live animals shall not be trans- food and water requirements of such ported with any material, substance animal while being so transported is af- (e.g., dry ice) or device which may rea- fixed to the outside of its primary en- sonably be expected to be injurious to closure. the health and well-being of the animals unless proper precaution is taken § 3.140 Care in transit. to prevent such injury. (a) During surface transportation, it shall be the responsibility of the driver § 3.139 Food and water requirements. or other employee to visually observe (a) All live animals shall be offered the live animals as frequently as cir- potable water within 4 hours prior to cumstances may dictate, but not less being transported in commerce. Deal- than once every 4 hours, to assure that ers, exhibitors, research facilities and they are receiving sufficient air for operators of auction sales shall provide normal breathing, their ambient tem- potable water to all live animals trans- peratures are within the prescribed ported in their own primary convey- limits, all other applicable standards ance at least every 12 hours after such are being complied with and to deter- transportation is initiated, and car- mine whether any of the live animals riers and intermediate handlers shall are in obvious physical distress and to provide potable water to all live ani- provide any needed veterinary care as mals at least every 12 hours after ac- soon as possible. When transported by ceptance for transportation in com- air, live animals shall be visually ob- merce: Provided, however, That except served by the carrier as frequently as as directed by hibernation, veterinary circumstances may dictate, but not treatment or other professionally ac- less than once every 4 hours, if the ani- cepted practices, those live animals mal cargo space is accessible during which, by common accepted practices, flight. If the animal cargo space is not require watering more frequently shall accessible during flight, the carrier be so watered. shall visually observe the live animals (b) Each live animal shall be fed at whenever loaded and unloaded and least once in each 24 hour period, ex- whenever the animal cargo space is cept as directed by hibernation, veteri- otherwise accessible to assure that nary treatment, normal fasts, or other they are receiving sufficient air for professionally accepted practices. normal breathing, their ambient tem- Those live animals which, by common peratures are within the prescribed

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limits, all other applicable standards lowed to exceed 29.5 °C. (85 °F.) at any are being complied with and to deter- time: Provided, however, That no live mine whether any such live animals animal shall be subjected to sur- are in obvious physical distress. The rounding air temperatures which ex- carrier shall provide any needed veteri- ceed 23.9 °C. (75 °F.) for more than 4 nary care as soon as possible. No ani- hours at any time. To ascertain com- mal in obvious physical distress shall pliance with the provisions of this be transported in commerce. paragraph, the air temperature around (b) Wild or otherwise dangerous ani- any live animal shall be measured and mals shall not be taken from their pri- read outside the primary enclosure mary enclosure except under extreme which contains such animal at a dis- emergency conditions: Provided, how- tance not to exceed .91 meters (3 feet) ever, That a temporary primary enclo- from any one of the external walls of sure may be used, if available, and such the primary enclosure and on a level temporary primary enclosure is struc- parallel to the bottom of such primary turally strong enough to prevent the enclosure at a point which approxi- escape of the animal. During the course mates half the distance between the of transportation, in commerce, live top and bottom of such primary enclo- animals shall not be removed from sure. their primary enclosures unless placed [43 FR 56217, Dec. 1, 1978. Redesignated at 44 in other primary enclosures or facili- FR 36874, July 22, 1979] ties conforming to the requirements provided in this subpart. § 3.142 Handling. (a) Carriers and intermediate han- § 3.141 Terminal facilities. dlers shall move live animals from the Carriers and intermediate handlers animal holding area of the terminal fa- shall not commingle live animal ship- cility to the primary conveyance and ments with inanimate cargo. All ani- from the primary conveyance to the mal holding areas of a terminal facility animal holding area of the terminal fa- of any carrier or intermediate handler cility as expeditiously as possible. Car- wherein live animal shipments are riers and intermediate handlers hold- maintained shall be cleaned and sani- ing any live animal in an animal hold- tized in a manner prescribed in § 3.141 ing area of a terminal facility or in of the standards often enough to pre- transporting any live animal from the vent an accumulation of debris or ex- animal holding area of the terminal fa- creta, to minimize vermin infestation cility to the primary conveyance and and to prevent a disease hazard. An ef- from the primary conveyance to the fective program for the control of in- animal holding area of the terminal fa- sects, ectoparasites, and avian and cility, including loading and unloading mammalian pests shall be established procedures, shall provide the following: and maintained for all animal holding (1) Shelter from sunlight. When sun- areas. Any animal holding area con- light is likely to cause overheating or taining live animals shall be provided discomfort, sufficient shade shall be with fresh air by means of windows, provided to protect the live animals doors vents, or air conditioning and from the direct rays of the sun and may be ventilated or air circulated by such live animals shall not be sub- means of fans, blowers, or an air condi- jected to surrounding air temperatures tioning system so as to minimize which exceed 29.5 °C. (85 °F), and which drafts, odors, and moisture condensa- shall be measured and read in the man- tion. Auxiliary ventilation, such as ex- ner prescribed in § 3.141 of this part, for haust fans and vents or fans or blowers a period of more than 45 minutes. or air conditioning shall be used for (2) Shelter from rain or snow. Live ani- any animal holding area containing mals shall be provided protection to live animals when the air temperature allow them to remain dry during rain within such animal holding area is 23.9 or snow. °C. (75.°F.) or higher. The air tempera- (3) Shelter from cold weather. Trans- ture around any live animal in any ani- porting devices shall be covered to pro- mal holding area shall not be allowed vide protection for live animals when to fall below 7.2 °C. (45 °F.) nor be al- the outdoor air temperature falls below

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10 °C. (50 °F) and such live animals Subpart B—Supplemental Rules of shall not be subjected to surrounding Practice air temperatures which fall below 7.2 °C. (45 °F.), and which shall be meas- § 4.10 Summary action. ured and read in the manner prescribed in § 3.141 of this part, for a period of (a) In any situation where the Ad- more than 45 minutes unless such ani- ministrator has reason to believe that mals are accompanied by a certificate any person licensed under the Act has of acclimation to lower temperatures violated or is violating any provision of as prescribed in § 3.136(c). the Act, or the regulations or stand- (b) Care shall be exercised to avoid ards issued thereunder, and he deems it handling of the primary enclosure in warranted under the circumstances, such a manner that may cause physical the Administrator may suspend such or emotional trauma to the live animal person’s license temporarily, for a pe- contained therein. riod not to exceed 21 days, effective, ex- (c) Primary enclosures used to trans- cept as provided in § 4.10(b), upon writ- port any live animal shall not be ten notification given to such person of tossed, dropped, or needlessly tilted the suspension of his license pursuant and shall not be stacked in a manner to § 1.147(b) of the Uniform Rules of which may reasonably be expected to Practice (7 CFR 1.147(b)). result in their falling. (b) In any case of actual or threatened physical harm to animals in vio- [43 FR 21167, May 16, 1978, as amended at 43 FR 56217, Dec. 1, 1978. Redesignated at 44 FR lation of the Act, or the regulations or 36874, July 22, 1979] standards issued thereunder, by a person licensed under the Act, the Admin- PART 4—RULES OF PRACTICE GOV- istrator may suspend such person’s li- ERNING PROCEEDINGS UNDER cense temporarily, for a period not to exceed 21 days, effective upon oral or THE ANIMAL WELFARE ACT written notification, whichever is earlier. In the event of oral notification, a Subpart A—General written confirmation thereof shall be Sec. given to such person pursuant to 4.1 Scope and applicability of rules of prac- § 1.147(b) of the Uniform Rules of Prac- tice. tice (7 CFR 1.147(b)) as promptly as circumstances permit. Subpart B—Supplemental Rules of Practice (c) The temporary suspension of a li- 4.10 Summary action. cense shall be in addition to any sanc- 4.11 Stipulations. tion which may be imposed against AUTHORITY: 7 U.S.C. 2149 and 2151; 7 CFR said person by the Secretary pursuant 2.22, 2.80, and 371.7. to the Act after notice and opportunity for hearing. SOURCE: 42 FR 10959, Feb. 25, 1977, unless otherwise noted. § 4.11 Stipulations. Subpart A—General (a) At any time prior to the issuance of a complaint seeking a civil penalty § 4.1 Scope and applicability of rules under the Act, the Administrator, in of practice. his discretion, may enter into a stipu- The Uniform Rules of Practice for lation with any person in which: the Department of Agriculture promul- (1) The Administrator gives notice of gated in subpart H of part 1, subtitle A, an apparent violation of the Act, or the title 7, Code of Federal Regulations, regulations or standards issued there- are the Rules of Practice applicable to under, by such person and affords such adjudicatory, administrative pro- person an opportunity for a hearing re- ceedings under section 19 of the Animal garding the matter as provided by the Welfare Act (7 U.S.C. 2149). In addition, Act; the Supplemental Rules of Practice set (2) Such person expressly waives forth in subpart B of this part shall be hearing and agrees to pay a specified applicable to such proceedings. penalty within a designated time; and

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(3) The Administrator agrees to ac- of 1976 (Pub. L. 94–360), 15 U.S.C. 1821 et cept the specified penalty in settle- seq., and any legislation amendatory ment of the particular matter involved thereof. if it is paid within the designated time. Action device means any boot, collar, (b) If the specified penalty is not paid chain, roller, or other device which en- within the time designated in such a circles or is placed upon the lower ex- stipulation, the amount of the stipu- tremity of the leg of a horse in such a lated penalty shall not be relevant in manner that it can either rotate any respect to the penalty which may around the leg, or slide up and down be assessed after issuance of a com- the leg so as to cause friction, or which plaint. can strike the hoof, coronet band or fetlock joint. PART 11—HORSE PROTECTION Administrator means the Adminis- REGULATIONS trator, Animal and Plant Health In- spection Service, or any person author- Sec. ized to act for the Administrator. 11.1 Definitions. Animal and Plant Health Inspection 11.2 Prohibitions concerning exhibitors. Service (APHIS) means the Animal and 11.3 Scar rule. Plant Health Inspection Service of the 11.4 Inspection and detention of horses. United States Department of Agri- 11.5 Access to premises and records. culture. 11.6 Inspection space and facility require- APHIS representative means any em- ments. 11.7 Certification and licensing of des- ployee of APHIS, or any officer or em- ignated qualified persons (DQP’s). ployee of any State agency who is au- 11.20 Responsibilities and liabilities of man- thorized by the Administrator to per- agement. form inspections or any other func- 11.21 Inspection procedures for designated tions authorized by the Act, including qualified persons (DQPs). the inspection of the records of any 11.22 Records required and disposition horse show, horse exhibition, horse sale thereof. 11.23 Inspection of records. or horse auction. 11.24 Reporting by management. APHIS Show Veterinarian means the 11.25 Minimum penalties to be assessed and APHIS Doctor of Veterinary Medicine enforced by HIOs that license DQPs. responsible for the immediate super- 11.40 Prohibitions and requirements con- vision and conduct of the Department’s cerning persons involved in transpor- activities under the Act at any horse tation of certain horses. show, horse exhibition, horse sale or 11.41 Reporting required of horse industry horse auction. organizations or associations. Department means the United States AUTHORITY: 15 U.S.C. 1823–1825 and 1828; 7 Department of Agriculture. CFR 2.22, 2.80, and 371.7. Designated Qualified Person or DQP SOURCE: 44 FR 25179, Apr. 27, 1979, unless means a person meeting the require- otherwise noted. ments specified in § 11.7 of this part who has been licensed as a DQP by a § 11.1 Definitions. horse industry organization or associa- For the purpose of this part, unless tion having a DQP program certified by the context otherwise requires, the fol- the Department and who may be ap- lowing terms shall have the meanings pointed and delegated authority by the assigned to them in this section. The management of any horse show, horse singular form shall also impart the plu- exhibition, horse sale or horse auction ral and the masculine form shall also under section 4 of the Act to detect or impart the feminine. Words of art un- diagnose horses which are sore or to defined in the following paragraphs otherwise inspect horses and any shall have the meaning attributed to records pertaining to such horses for them by trade usage or general usage the purposes of enforcing the Act. as reflected by definition in a standard Exhibitor means (1) any person who dictionary, such as ‘‘Webster’s.’’ enters any horse, any person who al- Act means the Horse Protection Act lows his horse to be entered, or any of 1970 (Pub. L. 91–540) as amended by person who directs or allows any horse the Horse Protection Act Amendments in his custody or under his direction,

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control or supervision to be entered in ing, rubbing, palpating and observation any horse show or horse exhibition; (2) of vital signs, and the use of any diag- any person who shows or exhibits any nostic device or instrument, and may horse, any person who allows his horse require the removal of any shoe, pad, to be shown or exhibited, or any person action device, or any other equipment, who directs or allows any horse in his substance or paraphernalia from the custody or under his direction, control, horse when deemed necessary by the or supervision to be shown or exhibited person conducting such inspection. in any horse show or horse exhibition; Lubricant means mineral oil, glyc- (3) any person who enters or presents erine or petrolatum, or mixtures exclu- any horse for sale or auction, any per- sively thereof, that is applied to the son who allows his horse to be entered limbs of a horse solely for protective or presented for sale or auction, or any and lubricating purposes while the person who allows any horse in his cus- horse is being shown or exhibited at a tody or under his direction, control, or horse show, horse exhibition, horse sale supervision to be entered or presented or horse auction. for sale or auction in any horse sale or Management means any person or per- horse auction; or (4) any person who sons who organize, exercise control sells or auctions any horse, any person over, or administer or are responsible who allows his horse to be sold or auc- for organizing, directing, or admin- tioned, or any person who directs or al- istering any horse show, horse exhi- lows any horse in his custody or under bition, horse sale or horse auction and his direction, control, or supervision to specifically includes, but is not limited be sold or auctioned. to, the sponsoring organization and Horse means any member of the spe- show manager. cies Equus caballus. Person means any individual, cor- Horse exhibition means a public dis- poration, company, association, firm, play of any horses, singly or in groups, partnership, society, organization, but not in competition, except events joint stock company, or other legal en- where speed is the prime factor, rodeo tity. events, parades, or trail rides. Regional Director means the APHIS Horse industry organization or associa- veterinarian who is assigned by the Ad- tion means an organized group of peo- ministrator to supervise and perform ple, having a formal structure, who are official duties of APHIS under the Act 1 engaged in the promotion of horses in a specified State or States. means the Secretary of Ag- through the showing, exhibiting, sale, Secretary riculture or anyone who has heretofore auction, registry, or any activity or may hereafter be delegated author- which contributes to the advancement ity to act in his stead. of the horse. Show manager means the person who Horse sale or horse auction means any has been delegated primary authority event, public or private, at which by a sponsoring organization for man- horses are sold or auctioned, regardless aging a horse show, horse exhibition, of whether or not said horses are exhib- horse sale or horse auction. ited prior to or during the sale or auc- Sore when used to describe a horse tion. means: Horse show means a public display of (1) An irritating or blistering agent any horses, in competition, except has been applied, internally or exter- events where speed is the prime factor, nally by a person to any limb of a rodeo events, parades, or trail rides. horse, Inspection means the examination of (2) Any burn, cut, or laceration has any horse and any records pertaining been inflicted by a person on any limb to any horse by use of whatever means of a horse, are deemed appropriate and necessary for the purpose of determining compli- 1 ance with the Act and regulations. Information as to the name and address of the Regional Director for the State or States Such inspection may include, but is concerned can be obtained by writing to the not limited to, visual examination of a Animal and Plant Health Inspection Service, horse and records, actual physical ex- Animal Care, 4700 River Road Unit 84, River- amination of a horse including touch- dale, MD 20737–1234.

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(3) Any tack, nail, screw, or chemical with individual rollers of uniform size, agent has been injected by a person weight and configuration, provided into or used by a person on any limb of each such device may not weigh more a horse, or than 6 ounces, including the weight of (4) Any other substance or device has the fastener. been used by a person on any limb of a (2) Chains weighing more than 6 horse or a person has engaged in a ounces each, including the weight of practice involving a horse, and, as a re- the fastener. sult of such application, infliction, in- (3) Chains with links that are not of jection, use, or practice, such horse uniform size, weight and configuration; suffers, or can reasonably be expected and, chains that have twisted links or to suffer, physical pain or distress, in- double links. flammation, or lameness when walk- (4) Chains that have drop links on ing, trotting, or otherwise moving, ex- any horse that is being ridden, worked cept that such term does not include on a lead, or otherwise worked out or such an application, infliction, injec- moved about. tion, use, or practice in connection (5) More than one action device on with the therapeutic treatment of a any one limb of a horse. horse by or under the supervision of a (6) Chains or lignum vitae, stainless person licensed to practice veterinary steel, or aluminum rollers which are medicine in the State in which such not smooth and free of protrusions, treatment was given. projections, rust, corrosion, or rough Sponsoring organization means any or sharp edges. person under whose immediate aus- (7)(i) Boots, collars, or any other de- pices and responsibility a horse show, vices, with protrusions or swellings, or horse exhibition, horse sale, or horse rigid, rough, or sharp edges, seams or auction is conducted. any other abrasive or abusive surface State means any of the several that may contact a horse’s leg; and States, the District of Columbia, the (ii) Boots, collars, or any other de- Commonwealth of Puerto Rico, the vices that weigh more than 6 ounces, Virgin Islands, Guam, American except for soft rubber or soft leather Samoa, or the Trust Territory of the bell boots and quarter boots that are Pacific Islands. used as protective devices. [44 FR 1561, Jan. 5, 1979, as amended at 53 FR (8) Pads or other devices on yearling 14782, Apr. 26, 1988; 53 FR 28372, July 28, 1988; horses (horses up to 2 years old) that 56 FR 13749, Apr. 4, 1991; 59 FR 67612, Dec. 30, elevate or change the angle of such 1994; 63 FR 62927, Nov. 10, 1998] horses’ hooves in excess of 1 inch at the heel. § 11.2 Prohibitions concerning exhibi- (9) Any weight on yearling horses, ex- tors. cept a keg or similar conventional (a) General prohibitions. Notwith- horseshoe, and any horseshoe on year- standing the provisions of paragraph ling horses that weighs more than 16 (b) of this section, no chain, boot, roll- ounces. er, collar, action device, nor any other (10) Artificial extension of the toe device, method, practice, or substance length, whether accomplsihed with shall be used with respect to any horse pads, acrylics or any other material or at any horse show, horse exhibition, or combinations thereof, that exceeds 50 horse sale or auction if such use causes percent of the natural hoof length, as or can reasonably be expected to cause measured from the coronet band, at the such horse to be sore. center of the front pastern along the (b) Specific prohibitions. The use of front of the hoof wall, to the distal por- any of the following devices, equip- tion of the hoof wall at the tip of the ment, or practices on any horse at any toe. The artificial extension shall be horse show, horse exhibition, or horse measured from the distal portion of the sale or auction is prohibited: hoof wall at the tip of the toe at a 90 (1) All beads, bangles, rollers, and degree angle to the proximal (foot/ similar devices, with the exception of hoof) surface of the shoe. rollers made of lignum vitae (hard- (11) Toe length that does not exceed wood), aluminum, or stainless steel, the height of the heel by 1 inch or

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more. The length of the toe shall be (18) Shoeing a horse, or trimming a measured from the coronet band, at the horse’s hoof in a manner that will center of the front pastern along the cause such horse to suffer, or can rea- front of the hoof wall to the ground. sonably be expected to cause such The heel shall be measured from the horse to suffer pain or distress, inflam- coronet band, at the most lateral por- mation, or lameness when walking, tion of the rear pastern, at a 90 degree trotting, or otherwise moving. angle to the ground, not including nor- (19) Lead or other weights attached mal caulks at the rear of a horseshoe to the outside of the hoof wall, the out- that do not exceed 3⁄4 inch in length. side surface of the horseshoe, or any That portion of caulk at the rear of a portion of the pad except the bottom horseshoe in excess of 3⁄4 of an inch surface within the horseshoe. Pads may shall be added to the height of the heel not be hollowed out for the purpose of in determining the heel/toe ratio. inserting or affixing weights, and (12) Pads that are not made of leath- weights may not extend below the er, plastic, or a similar pliant material. bearing surface of the shoe. Hollow (13) Any object or material inserted shoes or artificial extensions filled between the pad and the hoof other with mercury or similar substances are than acceptable hoof packing, which prohibited. includes pine tar, oakum, live rubber, (c) Substances. All substances are pro- sponge rubber, silicone, commercial hibited on the extremities above the hoof packing or other substances used hoof of any Tennessee Walking Horse to maintain adequate frog pressure or or racking horse while being shown, ex- sole consistency. hibited, or offered for sale at any horse (14) Single or double rocker-bars on show, horse exhibition, or horse sale or the bottom surface of horseshoes which auction, except lubricants such as glyc- extend more than 11⁄2 inches back from erine, petrolatum, and mineral oil, or the point of the toe, or which would mixtures thereof: Provided, That: cause, or could reasonably be expected (1) The horse show, horse exhibition, to cause, an unsteadiness of stance in or horse sale or auction management the horse with resulting muscle and agrees to furnish all such lubricants tendon strain due to the horse’s weight and to maintain control over them and balance being focused upon a small when used at the horse show, horse ex- fulcrum point. 2 hibition, or horse sale or auction. (15) Metal hoof bands, such as used to (2) Any such lubricants shall be ap- anchor or strengthen pads and shoes, plied only after the horse has been in- placed less than 1⁄2 inch below the coro- spected by management or by a DQP net band. and shall only be applied under the su- (16) Metal hoof bands that can be eas- pervision of the horse show, horse exhi- ily and quickly loosened or tightened bition, or horse sale, or auction man- by hand, by means such as, but not agement. limited to, a wing-nut or similar fas- (3) Horse show, horse exhibition, or tener. horse sale or auction management (17) Any action device or any other makes such lubricants available to De- device that strikes the coronet band of partment personnel for inspection and the foot of a horse except for soft rub- sampling as they deem necessary. ber or soft leather bell boots that are (d) Competition restrictions—2 Year-Old used as protective devices. Horses. Horse show or horse exhibition workouts or performances of 2-year-old 2 This prohibition is not intended to dis- Tennessee Walking Horses and racking allow corrective devices, such as Memphis horses and working exhibitions of 2- bars which consist of a metal bar(s) crossing year-old Tennessee Walking Horses and from the ground surface of one side of the racking horses (horses eligible to be horseshoe to the ground surface of the other shown or exhibited in 2-year-old class- side of the horseshoe, and the purpose of es) at horse sales or horse auctions which is to correct a lameness or pathological condition of the foot: Provided, That that exceed a total of 10 minutes con- such metal bar(s) do not act as a single ful- tinuous workout or performance with- crum point so as to affect the balance of the out a minimum 5-minute rest period horse. between the first such 10-minute period

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and the second such 10-minute period, other bilateral evidence of abuse indic- and, more than two such 10-minute pe- ative of soring including, but not lim- riods per performance, class, or work- ited to, excessive loss of hair. out are prohibited. (b) The posterior surfaces of the pas- (e) Information requirements—horse re- terns (flexor surface), including the lated. Failing to provide information or sulcus or ‘‘pocket’’ may show bilateral providing any false or misleading infor- areas of uniformly thickened epithelial mation required by the Act or regula- tissue if such areas are free of prolifer- tions or requested by Department rep- ating granuloma tissue, irritation, resentatives, by any person that owns, moisture, edema, or other evidence of trains, shows, exhibits, or sells or has inflammation. custody of, or direction or control over [44 FR 25179, Apr. 27, 1979, as amended at 53 any horse shown, exhibited, sold, or FR 14782, Apr. 26, 1988, 53 FR 28373, July 28, auctioned or entered for the purpose of 1988] being shown, exhibited, sold, or auctioned at any horse show, horse exhi- § 11.4 Inspection and detention of bition, or horse sale or auction is pro- horses. hibited. Such information shall in- For the purpose of effective enforce- clude, but is not limited to: Informa- ment of the Act: tion concerning the registered name, (a) Each horse owner, exhibitor, markings, sex, age, and legal ownership trainer, or other person having custody of the horse; the name and address of of, or responsibility for, any horse at the horse’s training and/or stabling fa- any horse show, horse exhibition, or cilities; the name and address of the horse sale or auction, shall allow any owner, trainer, rider, any other exhibi- APHIS representative to reasonably in- tor, or other legal entity bearing respect such horse at all reasonable sponsibility for the horse; the class in times and places the APHIS represent- which the horse is entered or shown; ative may designate. Such inspections the exhibitor identification number; may be required of any horse which is and, any other information reasonably stabled, loaded on a trailer, being pre- related to the identification, owner- pared for show, exhibition, or sale or ship, control, direction, or supervision auction, being exercised or otherwise of any such horse. on the grounds of, or present at, any [44 FR 25179, Apr. 27, 1979, as amended at 53 horse show, horse exhibition, or horse FR 14782, Apr. 26, 1988, 53 FR 15641, May 2, sale or auction, whether or not such 1988, 53 FR 28372, July 28, 1988, 53 FR 41562, horse has or has not been shown, exhib- Oct. 24, 1988, 53 FR 45854, Nov. 14, 1988; 54 FR ited, or sold or auctioned, or has or has 7178, Feb. 17, 1989] not been entered for the purpose of § 11.3 Scar rule. being shown or exhibited or offered for sale or auction at any such horse show, The scar rule applies to all horses horse exhibition, or horse sale or auc- born on or after October 1, 1975. Horses tion. APHIS representatives will not subject to this rule that do not meet generally or routinely delay or inter- the following scar rule criteria shall be rupt actual individual classes or per- considered to be ‘‘sore’’ and are subject formances at horse shows, horse exhibi- to all prohibitions of section 5 of the tions, or horse sales or auctions for the Act. The scar rule criteria are as fol- purpose of examining horses, but they lows: may do so in extraordinary situations, (a) The anterior and anterior-lateral such as but not limited to, lack of surfaces of the fore pasterns (extensor proper facilities for inspection, refusal surface) must be free of bilateral of management to cooperate with De- granulomas, 5 other bilateral patholog- partment inspection efforts, reason to ical evidence of inflammation, and, believe that failure to immediately perform inspection may result in the 3,4 [Reserved] loss, removal, or masking of any evi- 5 Granuloma is defined as any one of a rather large group of fairly distinctive focal dence of a violation of the Act or the lesions that are formed as a result of inflam- regulations, or a request by manage- matory reactions caused by biological, ment that such inspections be per- chemical, or physical agents. formed by an APHIS representative.

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(b) When any APHIS representative etc., for such detained horse: Provided, notifies the owner, exhibitor, trainer, That: or other person having custody of or (1) Such feeding, watering, and other responsibility for a horse at any horse normal custodial and maintenance care show, horse exhibition, or horse sale or of the detained horse is rendered under auction that APHIS desires to inspect the direct supervision of an APHIS rep- such horse, it shall not be moved from resentative. the horse show, horse exhibition, or (2) Any non-emergency veterinary horse sale or auction until such inspec- care of the detained horse requiring the tion has been completed and the horse use, application, or injection of any has been released by an APHIS rep- drugs or other medication for thera- resentative. peutic or other purposes is rendered by (c) For the purpose of examination, a Doctor of Veterinary Medicine in the testing, or taking of evidence, APHIS presence of an APHIS representative representatives may detain for a period not to exceed 24 hours any horse, at and, the identity and dosage of the any horse show, horse exhibition, or drug or other medication used, applied, horse sale or auction, which is sore or or injected and its purpose is furnished which an APHIS veterinarian has prob- in writing to the APHIS representative able cause to believe is sore. Such de- prior to such use, application, or injec- tained horse may be marked for identi- tion by the Doctor of Veterinary Medi- fication and any such identifying cine attending the horse. The use, ap- markings shall not be removed by any plication, or injection of such drug or person other than an APHIS represent- other medication must be approved by ative. the APHIS Show Veterinarian or his (d) Detained horses shall be kept appointed representative. under the supervision of an APHIS rep- (f) It shall be the policy of APHIS to resentative or secured under an official inform the owner, trainer, exhibitor, or USDA seal or seals in a horse stall, other person having immediate custody horse trailer, or other facility to which of or responsibility for any horse alleg- access shall be limited. It shall be the edly found to be in violation of the Act policy of APHIS to have at least one or the regulations of such alleged vio- representative present in the imme- lation or violations before the horse is diate detention area when a horse is released by an APHIS representative. being held in detention. The official (g) The owner, trainer, exhibitor, or USDA seal or seals may not be broken other person having immediate custody or removed by any person other than of or responsibility for any horse or an APHIS representative, unless: horses that an APHIS representative (1) The life or well-being of the de- determines shall be detained for exam- tained horse is immediately endan- ination, testing, or taking of evidence gered by fire, flood, windstorm, or pursuant to paragraph (e) of this sec- other dire circumstances that are beyond human control. tion shall be informed after such deter- (2) The detained horse is in need of mination is made and shall allow said such immediate veterinary attention horse to be immediately put under the that its life may be in peril before an supervisory custody of APHIS or se- APHIS representative can be located. cured under official USDA seal as pro- (3) The horse has been detained for a vided in paragraph (d) of this section maximum 24-hour detention period, until the completion of such examina- and an APHIS representative is not tion, testing, or gathering of evidence, available to release the horse. or until the 24-hour detention period (e) The owner, exhibitor, trainer, or expires. other person having custody of or re- (h) The owner, trainer, exhibitor, or sponsibility for any horse detained by other person having custody of or re- APHIS for further examination, test- sponsibility for any horse allegedly ing, or the taking of evidence shall be found to be in violation of the Act or allowed to feed, water, and provide regulations, and who has been notified other normal custodial and mainte- of such alleged violation by an APHIS nance care, such as walking, grooming, representative as stated in paragraph

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(f) of this section, may request reexam- (b) Exhibitors. (1) Each horse owner, ination and testing of said horse within exhibitor, or other person having cus- a 24-hour period: Provided, That: tody of or responsibility for any horse (1) Such request is made to the at any horse show, horse exhibition, or APHIS Show Veterinarian immediately horse sale or auction shall, without fee, after the horse has been examined by charge, assessment, or other compensa- APHIS representatives and before such tion, admit any APHIS representative horse has been removed from the or Designated Qualified Person ap- APHIS inspection facilities; and pointed by management, to all areas of (2) The APHIS Show Veterinarian de- barns, compounds, horse vans, horse termines that sufficient cause for reex- trailers, stables, stalls, paddocks, or amination and testing exists; and other show, exhibition, or sale or auc- (3) The horse is maintained under tion grounds or related areas at any APHIS supervisory custody as pre- horse show, horse exhibition, or horse scribed in paragraph (d) of this section sale or auction, for the purpose of in- until such reexamination and testing specting any such horse at any and all has been completed. reasonable times. (i) The owner, exhibitor, trainer, or (2) Each owner, trainer, exhibitor, or other person having custody of, or re- other person having custody of or responsibility for any horse being in- sponsibility for, any horse at any horse spected shall render such assistance as show, horse exhibition, or horse sale or the APHIS representative may request auction shall promptly present his for purposes of such inspection. horse for inspection upon notification, (ii) [Reserved] orally or in writing, by any APHIS rep- [44 FR 25179, Apr. 27, 1979, as amended at 56 resentative or Designated Qualified FR 13750, Apr. 4, 1991] Person appointed by management, that said horse has been selected for exam- § 11.5 Access to premises and records. ination for the purpose of determining Requirements regarding access to whether such horse is in compliance premises for inspection of horses and with the Act and regulations. records are as follows: [44 FR 25179, Apr. 27, 1979, as amended at 56 (a) Management. (1) The management FR 13750, Apr. 4, 1991] of any horse show, horse exhibition, or horse sale or auction shall, without fee, § 11.6 Inspection space and facility re- charge, assessment, or other compensa- quirements. tion, provide APHIS representatives The management of every horse with unlimited access to the grand- show, horse exhibition, or horse sale or stands, sale ring, barns, stables, auction, containing Tennessee Walking grounds, offices, and all other areas of Horses or racking horses, shall provide, any horse show, horse exhibition, or without fee, sufficient space and facili- horse sale or auction, including any ad- ties for APHIS representatives to carry jacent areas under their direction, con- out their duties under the Act and reg- trol, or supervision for the purpose of ulations at every horse show, horse ex- inspecting any horses, or any records hibition, or horse sale or auction, con- required to be kept by regulation or taining Tennessee Walking Horses or otherwise maintained. racking horses, whether or not man- (2) The management of any horse agement has received prior notification show, horse exhibition, or horse sale or or otherwise knows that such show auction shall, without fee, charge, as- may be inspected by APHIS. The man- sessment, or other compensation, pro- agement of every horse show, horse ex- vide APHIS representatives with an hibition, horse sale or auction which adequate, safe, and accessible area for does not contain Tennessee Walking the visual inspection and observation Horses or racking horses shall provide, of horses while such horses are com- without fee, such sufficient space and petitively or otherwise performing at facilities when requested to do so by any horse show or horse exhibition, or APHIS representatives. With respect to while such horses are being sold or auc- such space and facilities, it shall be the tioned or offered for sale or auction at responsibility of management to pro- any horse sale or horse auction. vide at least the following:

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(a) Sufficient space in a convenient and soring practices (such as Doctors location to the horse show, horse exhi- of Veterinary Medicine with a small bition, or horse sale or auction arena, animal practice who own, train, judge, acceptable to the APHIS Show Veteri- or show horses, or Doctors of Veteri- narian, in which horses may be phys- nary Medicine who teach equine re- ically, thermographically, or otherwise lated subjects in an accredited college inspected. or school of veterinary medicine). Ac- (b) Protection from the elements of credited Doctors of Veterinary Medi- nature, such as rain, snow, sleet, hail, cine who meet these criteria may be li- windstorm, etc., if required by the censed as DQP’s by a horse industry or- APHIS Show Veterinarian. ganization or association whose DQP (c) A means to control crowds or on- program has been certified by the De- lookers in order that APHIS personnel partment under this part without un- may carry out their duties without in- dergoing the formal training require- terference and with a reasonable meas- ments set forth in this section. ure of safety, if requested by the (2) Farriers, horse trainers, and other APHIS Show Veterinarian. knowledgeable horsemen whose past (d) An accessible, reliable, and con- experience and training would qualify venient 110-volt electrical power them for positions as horse industry source, if electrical service is available organization or association stewards or at the show, exhibition, or sale or auc- judges (or their equivalent) and who tion site and is requested by the APHIS have been formally trained and li- Show Veterinarian. censed as DQP’s by a horse industry or- (e) An appropriate area adjacent to ganization or association whose DQP the inspection area for designated program has been certified by the De- horses to wait for inspection, and an partment in accordance with this sec- area to be used for detention of horses. tion. [44 FR 25181, Apr. 27, 1979, as amended at 56 (b) Certification requirements for DQP FR 13750, Apr. 4, 1991] programs. The Department will not license DQP’s on an individual basis. Li- § 11.7 Certification and licensing of designated qualified persons censing of DQP’s will be accomplished (DQP’s). only through DQP programs certified by the Department and initiated and (a) Basic qualifications of DQP appli- maintained by horse industry organiza- cants. DQP’s holding a valid, current tions or associations. Any horse indus- DQP license issued in accordance with try organization or association desir- this part may be appointed by the management of any horse show, horse exhi- ing Department certification to train bition, horse sale, or horse auction, as and license DQP’s under the Act shall 6 qualified persons in accordance with submit to the Administrator a formal section 4(c) of the Act, to inspect request in writing for certification of horses to detect or diagnose soring and its DQP program and a detailed outline to otherwise inspect horses, or any of such program for Department ap- records pertaining to any horse for the proval. Such outline shall include the purpose of enforcing the Act. Individ- organizational structure of such orga- uals who may be licensed as DQP’s nization or association and the names under this part shall be: of the officers or persons charged with (1) Doctors of Veterinary Medicine the management of the organization or who are accredited in any State by the association. The outline shall also con- United States Department of Agri- tain at least the following: culture under part 161 of chapter I, (1) The criteria to be used in select- title 9 of the Code of Federal Regula- ing DQP candidates and the minimum tions, and who are: qualifications and knowledge regarding (i) Members of the American Associa- horses each candidate must have in tion of Equine Practitioners, or order to be admitted to the program. (ii) Large animal practitioners with substantial equine experience, or 6 Animal and Plant Health Inspection Serv- (iii) Knowledgeable in the area of ice, Animal Care, 4700 River Road, Unit 84, equine lameness as related to soring Riverdale, Maryland 20737–1234.

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(2) A copy of the formal training pro- 10 days prior to each such clinic or gram, classroom and practical, re- seminar. quired to be completed by each DQP (v) One hour of classroom instruction candidate before being licensed by such regarding the DQP standards of con- horse industry organization or associa- duct promulgated by the licensing or- tion, including the minimum number ganization or association pursuant to of hours, classroom and practical, and paragraph (d)(7) of this section. the subject matter of the training pro- (vi) One hour of classroom instruc- gram. Such training program must tion on recordkeeping and reporting re- meet the following minimum standards quirements and procedures. in order to be certified by the Depart- (3) A sample of a written examina- ment under the Act. tion which must be passed by DQP can- (i) Two hours of classroom instruc- didates for successful completion of the tion on the anatomy and physiology of program along with sample answers the limbs of a horse. The instructor and the scoring thereof, and proposed teaching the course must be specified, passing and failing standards. and a resume of said instructor’s back- (4) The criteria to be used to deter- ground, experience, and qualifications mine the qualifications and perform- to teach such course shall be provided ance abilities of DQP candidates selected for the training program and the to the Administrator. 6 criteria used to indicate successful (ii) Two hours of classroom instruc- completion of the training program, in tion on the Horse Protection Act and addition to the written examination re- regulations and their interpretation. quired in paragraph (b)(3) of this sec- Instructors for this course must be fur- tion. nished or recommended by the Depart- (5) The criteria and schedule for a ment. Requests for instructors to be continuing education program and the furnished or recommended must be criteria and methods of monitoring and 6 made to the Administrator in writing appraising performance for continued at least 30 days prior to such course. licensing of DQP’s by such organiza- (iii) Four hours of classroom instruction or association. A continuing edu- tion on the history of soring, the phys- cation program for DQP’s shall consist ical examination procedures necessary of not less than 4 hours of instruction to detect soring, the detection and di- per year. agnosis of soring, and related subjects. (6) Procedures for monitoring horses The instructor teaching the course in the unloading, preparation, warmup, must be specified and a summary of and barn areas, or other such areas. said instructor’s background, experi- Such monitoring may include any ence, and qualifications to teach such horse that is stabled, loaded on a trail- course must be provided to the Admin- er, being prepared for show, exhibition, istrator. 6 sale, or auction, or exercised, or that is (iv) Four hours of practical instruc- otherwise on the grounds of, or present tion in clinics and seminars utilizing at, any horse show, horse exhibition, or live horses with actual application of horse sale or auction. the knowledge gained in the classroom (7) The methods to be used to insure subjects covered in paragraphs (b)(2)(i), uniform interpretation and enforce- (ii), and (iii) of this section. Methods ment of the Horse Protection Act and and procedures required to perform a regulations by DQP’s and uniform pro- thorough and uniform examination of a cedures for inspecting horses for com- horse shall be included. The names of pliance with the Act and regulations; the instructors and a resume of their (8) Standards of conduct for DQP’s background, academic and practical promulgated by the organization or as- experience, and qualifications to sociation in accordance with paragraph present such instruction shall be pro- (d)(7) of this section; and vided to the Administrator. 6 Notifica- (9) A formal request for Department tion of the actual date, time, duration, certification of the DQP program. subject matter, and geographic loca- The horse industry organizations or as- tion of such clinics or seminars must sociations that have formally re- be sent to the Administrator 6 at least quested Department certification of

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their DQP training, enforcement, and years following the first such violation, maintenance program will receive a and for a period of at least 5 years fol- formal notice of certification from the lowing the second such violation and Department, or the reasons, in writing, any subsequent violation; why certification of such program can- (5) Not license any person as a DQP not be approved. A current list of cer- until such person has attended and tified DQP programs and licensed worked two recognized or affiliated DQP’s will be published in the FEDERAL horse shows, horse exhibitions, horse REGISTER at least once each year, and sales, or horse auctions as an appren- as may be further required for the pur- tice DQP and has demonstrated the pose of deleting programs and names of ability, qualifications, knowledge and DQP’s that are no longer certified or li- integrity required to satisfactorily exe- censed, and of adding the names of pro- cute the duties and responsibilities of a grams and DQP’s that have been cer- DQP; tified or licensed subsequent to the (6) Not license any person as a DQP if publication of the previous list. such person has been disqualified by (c) Licensing of DQP’s. Each horse in- the Secretary from making detection, dustry organization or association re- diagnosis, or inspection for the purpose ceiving Department certification for of enforcing the Act, or if such person’s the training and licensing of DQP’s DQP license is canceled by another under the Act shall: horse industry organization or associa- (1) Issue each DQP licensed by such tion. horse industry organization or association a numbered identification card (d) Requirements to be met by DQP’s bearing the name and personal signa- and Licensing Organizations or Associa- ture of the DQP, a picture of the DQP, tions. (1) Any licensed DQP appointed and the name and address, including by the management of any horse show, the street address or post office box horse exhibition, horse sale or auction and zip code, of the licensing organiza- to inspect horses for the purpose of de- tion or association; tecting and determining or diagnosing (2) Submit a list to the Adminis- horses which are sore and to otherwise trator 6 of names and addresses includ- inspect horses for the purpose of en- ing street address or post office box forcing the Act and regulations, shall and zip code, of all DQP’s that have keep and maintain the following infor- successfully completed the certified mation and records concerning any DQP program and have been licensed horse which said DQP recommends be under the Act and regulations by such disqualified or excused for any reason horse industry organization or associa- at such horse show, horse exhibition, tion; horse sale or auction, from being (3) Notify the Department of any ad- shown, exhibited, sold or auctioned, in ditions or deletions of names of li- a uniform format required by the horse censed DQP’s from the licensed DQP industry organization or association list submitted to the Department or of that has licensed said DQP: any change in the address of any li- (i) The name and address, including censed DQP or any warnings and li- street address or post office box and zip cense revocations issued to any DQP li- code, of the show and the show man- censed by such horse industry organi- ager. zation or association within 10 days of (ii) The name and address, including such change; street address or post office box and zip (4) Not license any person as a DQP if code, of the horse owner. such person has been convicted of any (iii) The name and address, including violation of the Act or regulations oc- street address or post office box and zip curring after July 13, 1976, or paid any code, of the horse trainer. fine or civil penalty in settlement of (iv) The name and address, including any proceeding regarding a violation of street address or post office box and zip the Act or regulations occurring after code, of the horse exhibitor. July 13, 1976, for a period of at least 2 (v) The exhibitors number and class number, or the sale or auction tag 6 See footnote 6 to this section. number of said horse.

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(vi) The date and time of the inspec- DQP recommended be disqualified or tion. excused for any reason. The informa- (vii) A detailed description of all of tion concerning the identity of such the DQP’s findings and the nature of horses shall include: the alleged violation, or other reason (A) The registered name of each for disqualifying or excusing the horse, horse. including said DQP’s statement regard- (B) The name and address of the ing the evidence or facts upon which owner, trainer, exhibitor, or other per- the decision to disqualify or excuse son having custody of or responsibility said horse was based. for the care of each such horse dis- (viii) The name, age, sex, color, and qualified or excused. markings of the horse; and (4) Each horse industry organization (ix) The name or names of the show or association having a Department manager or other management rep- certified DQP program shall provide, resentative notified by the DQP that by certified mail if personal service is such horse should be excused or dis- not possible, to the trainer and owner qualified and whether or not such man- of each horse allegedly found in viola- ager or management representative ex- tion of the Act or its regulations or cused or disqualified such horse. otherwise disqualified or excused for Copies of the above records shall be any reason, the following information; submitted by the involved DQP to the (i) The name and date of the show, horse industry organization or associa- exhibition, sale, or auction. tion that has licensed said DQP within (ii) The name of the horse and the 72 hours after the horse show, horse ex- reason why said horse was excused, dis- hibition, horse sale, or horse auction is qualified, or alleged to be in violation over. (2) The DQP shall inform the custo- of the Act or its regulations. dian of each horse allegedly found in (5) Each horse industry organization violation of the Act or its regulations, or association having a Department or disqualified or excused for any other certified DQP program shall provide reason, of such action and the specific each of its licensed DQP’s with a cur- reasons for such action. rent list of all persons that have been (3) Each horse industry organization disqualified by order of the Secretary or association having a Department from showing or exhibiting any horse, certified DQP program shall submit a or judging or managing any horse report to the Department containing show, horse exhibition, horse sale, or the following information, from horse auction. The Department will records required in paragraph (d)(1) of make such list available, on a current this section and other available basis, to organizations and associations sources, to the Department on a maintaining a certified DQP program. monthly basis: (6) Each horse industry organization (i) The identity of all horse shows, or association having a Department horse exhibitions, horse sales, or horse certified DQP program shall develop auctions that have retained the serv- and provide a continuing education ices of DQP’s licensed by said organiza- program for licensed DQP’s which pro- tion or association during the month vides not less than 4 hours of instruc- covered by the report. Information con- tion per year to each licensed DQP. cerning the identity of such horse (7) Each horse industry organization shows, horse exhibitions, horse sales, or association having a Department or horse auctions shall include: certified DQP program shall promul- (A) The name and location of the gate standards of conduct for its show, exhibition, sale, or auction. DQP’s, and shall provide administra- (B) The name and address of the man- tive procedures within the organization ager. or association for initiating, maintain- (C) The date or dates of the show, ex- ing, and enforcing such standards. The hibition, sale, or auction. procedures shall include the causes for (ii) The identity of all horses at each and methods to be utilized for can- horse show, horse exhibition, horse celing the license of any DQP who fails sale, or horse auction that the licensed to properly and adequately carry out

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his duties. Minimum standards of con- settlement of any proceeding regarding duct for DQP’s shall include the fol- a violation of the Act or regulations lowing; occurring after July 13, 1976. (i) A DQP shall not exhibit any horse (f) Cancellation of DQP license. (1) at any horse show or horse exhibition, Each horse industry organization or as- or sell, auction, or pruchase any horse sociation having a DQP program cer- sold at a horse sale or horse auction at tified by the Department shall issue a which he or she has been appointed to written warning to any DQP whom it inspect horses; has licensed who violates the rules, (ii) A DQP shall not inspect horses at regulations, by-laws, or standards of any horse show, horse exhibition, horse conduct promulgated by such horse in- sale or horse auction in which a horse dustry organization or association pur- or horses owned by a member of the suant to this section, who fails to fol- DQP’s immediate family or the DQP’s low the procedures set forth in § 11.21 of employer are competing or are being this part, or who otherwise carries out offered for sale; his duties and responsibilities in a less (iii) A DQP shall follow the uniform than satisfactory manner, and shall inspection procedures of his certified cancel the license of any DQP after a organization or association when in- second violation. Upon cancellation of specting horses; and his DQP license, the DQP may, within (iv) The DQP shall immediately in- 30 days thereafter, request a hearing form management of each case regard- before a review committee of not less ing any horse which, in his opinion, is than three persons appointed by the li- in violation of the Act or regulations. censing horse industry organization or (e) Prohibition of appointment of cer- association. If the review committee tain persons to perform duties under the sustains the cancellation of the license, Act. The management of any horse the DQP may appeal the decision of show, horse exhibition, horse sale, or such committee to the Administrator horse auction shall not appoint any within 30 days from the date of such person to detect and diagnose horses decision, and the Administrator shall which are sore or to otherwise inspect make a final determination in the mat- horses for the purpose of enforcing the ter. If the Administrator finds, after Act, if that person: providing the DQP whose license has (1) Does not hold a valid, current been canceled with a notice and an op- DQP license issued by a horse industry portunity for a hearing, 7 that there is organization or association having a sufficient cause for the committee’s de- DQP program certified by the Depart- termination regarding license cancella- ment. tion, he shall issue a decision sus- (2) Has had his DQP license canceled taining such determination. If he does by the licensing organization or asso- not find that there was sufficient cause ciation. to cancel the license, the licensing or- (3) Is disqualified by the Secretary from performing diagnosis, detection, ganization or association shall rein- and inspection under the Act, after no- state the license. tice and opportunity for a hearing, 7 (2) Each horse industry organization when the Secretary finds that such per- or association having a Department son is unfit to perform such diagnosis, certified DQP program shall cancel the detection, or inspection because he has license of any DQP licensed under its failed to perform his duties in accord- program who has been convicted of any ance with the Act or regulations, or be- violation of the Act or regulations or cause he has been convicted of a viola- of any DQP who has paid a fine or civil tion of any provision of the Act or reg- penalty in settlement of any alleged ulations occurring after July 13, 1976, violation of the Act or regulations if or has paid any fine or civil penalty in such alleged violation occurred after July 13, 1976. (g) Revocation of DQP program certifi- 7 Hearing would be in accordance with the Uniform Rules of Practice for the Depart- cation of horse industry organizations or ment of Agriculture in subpart H of part 1, associations. Any horse industry organi- subtitle A, title 7, Code of Federal Regula- zation or association having a Depart- tions (7 CFR 1.130 et seq.) ment certified DQP program that has

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not received Department approval of bition, horse sale, or horse auction. the inspection procedures provided for Horses entered for sale or auction at a in paragraph (b)(6) of this section, or horse sale or horse auction must be that otherwise fails to comply with the identified as sore or otherwise in viola- requirements contained in this part, tion of the Act or regulations prior to may have such certification of its DQP the sale or auction and prohibited from program revoked, unless, upon written entering the sale or auction ring. Sore notification from the Department of horses or horses otherwise in violation such failure to comply with the re- of the Act or regulations that have quirements in this section, such orga- been entered in a horse show or horse nization or association takes imme- exhibition for the purpose of show or diate action to rectify such failure and exhibition must be identified and ex- takes appropriate steps to prevent a re- cused prior to the show or exhibition. currence of such noncompliance within Any horses found to be sore or other- the time period specified in the Depart- wise in violation of the Act or regula- ment notification, or otherwise ade- tions during actual participation in the quately explains such failure to comply show or exhibition, must be removed to the satisfaction of the Department. from further participation prior to the Any horse industry organization or as- tyeing of the class or the completion of sociation whose DQP program certifi- the exhibition. All horses tyed first in cation has been revoked may appeal each Tennessee Walking Horse or such revocation to the Administrator 6 racking horse class or event at any in writing within 30 days after the date horse show or horse exhibition shall be of such revocation and, if requested, inspected after being shown or exhib- shall be afforded an opportunity for a ited to determine if such horses are hearing. 7 All DQP licenses issued by a sore or otherwise in violation of the horse industry organization or associa- Act or regulations. tion whose DQP program certification (b)(1) The management of any horse has been revoked shall expire 30 days show, horse exhibition, horse sale or after the date of such revocation, or 15 auction which designates and appoints days after the date the revocation be- a Designated Qualified Person (or per- comes final after appeal, unless they sons) to inspect horses shall accord are transferred to a horse industry or- said DQP access to all records and ganization or association having a pro- areas of the grounds of such show, ex- gram currently certified by the Depart- hibition, sale, or auction and the same ment. right to inspect horses and records as (Approved by the Office of Management and is accorded to any APHIS representa- Budget under control number 0579–0056) tive. Further, management shall not [44 FR 1563, Jan. 5, 1979, as amended at 44 FR take any action which would interfere 25182, Apr. 27, 1979; 48 FR 57471, Dec. 30, 1983; with or influence said DQP in carrying 55 FR 41993, Oct. 17, 1990; 56 FR 13750, Apr. 4, out his duties or making decisions con- 1991; 59 FR 67612, Dec. 30, 1994; 63 FR 62927, cerning whether or not any horse is Nov. 10, 1998; 77 FR 33618, June 7, 2012] sore or otherwise in violation of the Act or regulations. In the event man- § 11.20 Responsibilities and liabilities agement is dissatisfied with the per- of management. formance of a particular DQP, includ- (a) The management of any horse ing disagreement with decisions con- show, horse exhibition, or horse sale or cerning violations, management shall auction which does not appoint and re- not dismiss or otherwise interfere with tain a DQP shall be responsible for said DQP during the DQP’s appointed identifying all horses that are sore or tour of duty. 8 However, management otherwise in violation of the Act or should immediately notify, in writing, regulations, and shall disqualify or dis- the Department 6 and the organization allow any horses which are sore or oth- or association that licensed the DQP, erwise in violation of the Act or regu- as to why the performance of said DQP lations from participating or competing in any horse show, horse exhi- 8 The duration of the show, exhibition, or sale or auction. 6,7 See previous footnotes 6 and 7. 6 See footnote 6 to § 11.7.

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was inadequate or otherwise unsatis- volving said horse has begun or before factory. Management which designates said horse is offered for sale or auction. and appoints a DQP shall immediately (c) The management of any horse disqualify or disallow from being show, exhibition, sale, or auction that shown, exhibited, sold, or auctioned designates and appoints a DQP to in- any horse identified by the DQP to be spect horses shall appoint and des- sore or otherwise in violation of the ignate at least two DQP’s when more Act or regulations or any horse other- than 150 horses are entered. wise known by management to be sore or in violation of the Act or regula- (Approved by the Office of Management and tions. Should management fail to dis- Budget under control number 0579–0056) qualify or disallow from being shown, [44 FR 25182, Apr. 27, 1979, as amended at 48 exhibited, sold or auctioned any such FR 57471, Dec. 30, 1983; 55 FR 41993, Oct. 17, horse, said management shall assume 1990; 56 FR 13750, Apr. 4, 1991; 57 FR 62175, full responsibility for and liabilities Dec. 30, 1992] arising from the showing, exhibition, sale, or auction of said horses. § 11.21 Inspection procedures for des- (2) The DQP shall physically inspect: ignated qualified persons (DQPs). (i) All Tennessee Walking Horses and (a)(1) During the preshow inspection, racking horses entered for sale or auc- the DQP shall direct the custodian of tion, (ii) all Tennessee Walking Horses the horse to walk and turn the horse in and racking horses entered in any ani- a manner that allows the DQP to deter- mated gait class (whether under saddle, mine whether the horse exhibits signs horse to cart, or otherwise), (iii) all of soreness. The DQP shall determine Tennessee Walking Horses and racking whether the horse moves in a free and horses entered for exhibition before easy manner and is free of any signs of they are admitted to be shown, exhib- soreness. ited, sold, or auctioned, and (iv) all (2) The DQP shall digitally palpate Tennessee Walking Horses and racking the front limbs of the horse from knee horses tyed first in their class or event to hoof, with particular emphasis on at any horse show, horse exhibition, the pasterns and fetlocks. The DQP horse sale, or horse auction. Such in- shall examine the posterior surface of spection shall be for the purpose of de- the pastern by picking up the foot and termining whether any such horses are examining the posterior (flexor) sur- in violation of the Act or regulations. face. The DQP shall apply digital pres- Such physical examination shall be sure to the pocket (sulcus), including conducted in accordance with the in- the bulbs of the heel, and continue the spection procedures provided for in palpation to the medial and lateral sur- § 11.21 of this part. The DQP shall observe horses in the warmup ring and faces of the pastern, being careful to during actual performances whenever observe for responses to pain in the possible, and shall inspect any Ten- horse. While continuing to hold onto nessee Walking Horse or racking horse the pastern, the DQP shall extend the at any time he deems necessary to de- foot and leg of the horse to examine termine whether any such horse shown, the front (extensor) surfaces, including exhibited, sold, or auctioned is in vio- the coronary band. The DQP may ex- lation of the Act or regulations. If amine the rear limbs of all horses in- present at other shows, he shall exam- spected after showing, and may examine any horse which he determines ine the rear limbs of any horse exam- should be examined for compliance ined preshow or on the showgrounds with the Act and regulations. when he deems it necessary, except (3) The DQP shall immediately re- that the DQP shall examine the rear port, to the management of any horse limbs of all horses exhibiting lesions show, horse exhibition, or horse sale or on, or unusual movement of, the rear auction, any horse which, in his opin- legs. While carrying out the procedures ion, is sore or otherwise in violation of set forth in this paragraph, the DQP the Act or regulations. Such report shall also inspect the horse to deter- shall be made, whenever possible, be- mine whether the provisions of § 11.3 of fore the show class or exhibitioin in- this part are being complied with, and

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particularly whether there is any evi- § 11.22 Records required and disposi- dence of inflammation, edema, or pro- tion thereof. liferating granuloma tissue. (a) The management of any horse (3) The DQP shall observe and inspect show, horse exhibition, or horse sale or all horses for compliance with the pro- auction, that contains Tennessee Walk- visions set forth in § 11.2(a) through ing Horses or racking horses, shall § 11.2(c) of this part. All action devices, maintain for a period of at least 90 pads, and other equipment shall be ob- days following the closing date of said served and/or examined to assure that show, exhibition, or sale or auction, all they are in compliance with the regula- pertinent records containing: tions. All such equipment on horses ex- (1) The dates and place of the horse amined postshow, and on horses exam- show, horse exhibition, horse sale, or ined preshow that are not clearly in horse auction. compliance, shall be weighed and/or (2) The name and address (including measured. street address or post office box number and ZIP code) of the sponsoring or- (4) The DQP shall instruct the custo- ganization. dian of the horse to control it by hold- (3) The name and address of the horse ing the reins approximately 18 inches show, exhibition, horse sale or horse from the bit shank. The DQP shall not auction management. be required to examine a horse if it is (4) The name and address (including presented in a manner that might street address or post office box num- cause the horse not to react to a DQP’s ber and ZIP code) of the DQP, if any, examination, or if whips, cigarette employed to conduct inspections under smoke, or other actions or para- § 11.20; and, the name of the horse in- phernalia are used to distract a horse dustry organization or association cer- during examination. All such incidents tifying the DQP. shall be reported to the show manage- (5) The name and address (including ment and the DQP licensing organiza- street address or post office box num- tion. ber, and ZIP code) of each show judge. (b) The DQP shall inspect horses no (6) A copy of each class or sale sheet more than three classes ahead of the containing the names of horses, the time the inspected horses are to be names and addresses (including street shown, except that, in shows with address, post office box and ZIP code) fewer than 150 horses, the DQP shall in- of horse owners, the exhibitor number spect horses no more than 2 classes and class number, or sale number as- ahead of the time the inspected horses signed to each horse, the show class or are to be shown. Inspected horses shall sale lot number, and the name and ad- be held in a designated area that is dress (including street address, post of- under observation by the DQP or fice box, and ZIP code) of the person APHIS representative. Horses shall not paying the entry fee and entering the be permitted to leave the designated horse in a horse show, horse exhibition, area before showing. Only the horse, or horse sale or auction. the rider, the groom, the trainer, the (7) A copy of the official horse show, DQP(s) and APHIS representatives horse exhibition, horse sale, or horse shall be allowed in the designated area. auction program, if any such program (c) The DQP may carry out addi- has been prepared. tional inspection procedures as he (8) The identification of each horse, deems necessary to determine whether including the name of the horse, the the horse is sore. name and address (including street address, post office box, and ZIP code) of (d) The HIO that licensed the DQP the owner, the trainer, the rider or shall assess and enforce penalties for other exhibitor, and the location (in- violations in accordance with § 11.25 cluding street address, post office box, and shall report all violations in ac- and ZIP code) of the home barn or cordance with § 11.20(b)(4). other facility where the horse is sta- [55 FR 41993, Oct. 17, 1990; as amended at 56 bled. FR 13750, Apr. 4, 1991; 57 FR 62175, Dec. 30, (b) The management of any horse 1992; 77 FR 33618, June 7, 2012] show, horse exhibition, or horse sale or

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auction containing Tennessee Walking upon the request of the APHIS rep- Horses or racking horses shall des- resentative. ignate a person to maintain the records [44 FR 25179, Apr. 27, 1979. Redesignated at 55 required in this section. FR 41993, Oct. 17, 1990, as amended at 56 FR (c) The management of any horse 13750, Apr. 4, 1991] show, horse exhibition, or horse sale or auction containing Tennessee Walking § 11.24 Reporting by management. Horses or racking horses shall furnish (a) Within 5 days following the con- to any APHIS representative, upon re- clusion of any horse show, horse exhi- quest, the name and address (including bition, or horse sale or auction, con- street address, or post office box, and taining Tennessee Walking Horses or ZIP code) of the person designated by racking horses, the managements of the sponsoring organization or man- such show, exhibition, sale or auction 1 ager to maintain the records required shall submit to the Regional Director by this section. for the State in which the show, exhibition, sale or auction was held, the in- (d) The Administrator may, in spe- formation required by § 11.22(a)(1) cific cases, require that a horse show, through (6) for each horse excused or horse exhibition, or horse sale or auc- disqualified by management or its rep- tion records be maintained by manage- resentatives from being shown, exhib- ment for a period in excess of 90 days. ited, sold or auctioned, and the reasons (Approved by the Office of Management and for such action. If no horses are ex- Budget under control numbers 0579–0056, and cused or disqualified, the management 0579–0058) shall submit a report so stating. (b) Within 5 days following the con- (44 U.S.C. 3506) clusion of any horse show, horse exhi- [44 FR 25179, Apr. 27, 1979, as amended at 48 bition, or horse sale or auction which FR 57471, Dec. 30, 1983. Redesignated at 55 FR does not contain Tennessee Walking 41993, Oct. 17, 1990; 56 FR 13750, Apr. 4, 1991] Horses or racking horses, the management of such show, exhibition, sale or § 11.23 Inspection of records. auction shall inform the Regional Di- (a) The management of any horse rector for the State in which the show, show, horse exhibition, or horse sale or exhibition, sale or auction was held, of auction shall permit any APHIS rep- any case where a horse was excused or resentative, upon request, to examine disqualified by management or its rep- and make copies of any and all records resentatives from being shown, exhib- pertaining to any horse, either re- ited, sold or auctioned because it was quired in any part of the regulations, found to be sore. or otherwise maintained, during ordi- (Approved by the Office of Management and nary business hours or such other Budget under control number 0579–0056) times as may be mutually agreed upon. [44 FR 25179, Apr. 27, 1979, as amended at 48 A room, table, or other facilities nec- FR 57471, Dec. 30, 1983; 55 FR 41994, Oct. 17, essary for proper examination of such 1990; 56 FR 13750, Apr. 4, 1991; 63 FR 62927, records shall be made available to the Nov. 10, 1998] APHIS representative. § 11.25 Minimum penalties to be as- (b) Horse industry organizations or sessed and enforced by HIOs that li- associations who train, maintain, and cense DQPs. license DQP’s under a certified DQP (a) Rulebook. Each HIO that licenses program shall permit any APHIS rep- DQPs in accordance with § 11.7 must in- resentative, upon request, to examine clude in its rulebook, and enforce, pen- and copy any and all records relating alties for the violations listed in this to the DQP program which are required section that equal or exceed the pen- by any part of the regulations. Such re- alties listed in paragraph (c) of this quests shall be made during ordinary section and must also enforce the re- business hours or such other times as quirement in paragraph (d) of this sec- mutually agreed upon. A room, table or tion. other facilities necessary for proper examination shall be made available 1 See footnote 1 to § 11.1.

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(b) Suspensions. (1) For the violations show, exhibition, sale, or auction. First listed in paragraph (c) of this section offense: Suspension for 60 days. Second that require a suspension, any individ- offense: Suspension for 120 days. Third uals who are responsible for showing offense and any subsequent offenses: the horse, exhibiting the horse, enter- Suspension for 1 year. ing or allowing the entry of the horse (3) Scar rule violation. A horse is found in a show or exhibition, selling the to be in violation of the scar rule in horse, auctioning the horse, or offering § 11.3. The horse must be dismissed the horse for sale or auction must be from the remainder of the horse show, suspended. This may include, but may exhibition, sale, or auction. First of- not be limited to, the manager, trainer, fense: Suspension for 2 weeks (14 days). rider, custodian, or seller, as applica- Second offense: Suspension for 60 days. ble. In addition, if the owner allowed Third offense and any subsequent of- any activity listed in this paragraph, fenses: Suspension for 1 year. the owner must be suspended as well. (4) Foreign substance violations. Viola- (2) Any person who is responsible for tions of the prohibition against the use the shipping, moving, delivering, or re- of foreign substances in § 11.2(c). ceiving of any horse that is found to be bilaterally sore or unilaterally sore as (i) Before or during the show, exhi- defined in paragraph (c) of this section, bition, sale, or auction. The horse must in violation of the scar rule in § 11.3, or be dismissed from the remainder of the in violation of the prohibition against horse show, exhibition, sale, or auc- the use of foreign substances in tion. § 11.2(c), with reason to believe that (ii) After the show, exhibition, sale, or such horse was to be shown, exhibited, auction. Suspension for 2 weeks (14 entered for the purpose of being shown days). The horse must be dismissed or exhibited, sold, auctioned, or offered from the remainder of the horse show, for sale in any horse show, horse exhi- exhibition, sale, or auction. bition, or horse sale or auction, must (5) Equipment violation. Violations of be suspended; Provided, that this re- the equipment-related prohibitions in quirement does not apply if the horse § 11.2(b)(1) through (b)(10) and (b)(12) was transported by a common or con- through (b)(17). tract carrier or an employee thereof in (i) Before or during the show, exhi- the usual course of the carrier’s busi- bition, sale, or auction. The horse must ness or the employee’s employment, be dismissed from the remainder of the unless the carrier or employee had rea- horse show, exhibition, sale, or auc- son to believe that the horse was sore. tion. (3) A person who is suspended must (ii) After the show, exhibition, sale, or not be permitted to show or exhibit auction. Suspension for 2 weeks (14 any horse or judge or manage any days). The horse must be dismissed horse show, horse exhibition, or horse from the remainder of the horse show, sale or auction for the duration of the exhibition, sale, or auction. suspension. (6) Shoeing violation. Violation of the (4) Any person with multiple suspen- shoeing-related prohibitions in sions must serve them consecutively, § 11.2(b)(18). The horse must be dis- not concurrently. missed from the remainder of the horse (c) Minimum penalties—(1) Bilateral show, exhibition, sale, or auction. sore. A horse is found to be sore in both its forelimbs or hindlimbs. The horse (7) Heel-toe ratio. Violation of the must be dismissed from the remainder heel-toe ratio requirement in of the horse show, exhibition, sale, or § 11.2(b)(11). The horse must be dis- auction. First offense: Suspension for 1 missed from the remainder of the horse year. Second offense: Suspension for 2 show, exhibition, sale, or auction. years. Third offense and any subse- (8) Suspension violation. A violation of quent offenses: Suspension for 4 years. any suspension penalty previously (2) Unilateral sore. A horse is found to issued. Suspension for an additional 6 be sore in one of its forelimbs or months (180 days) for each occurrence. hindlimbs. The horse must be dis- (d) Unruly or fractious horse. A horse missed from the remainder of the horse that cannot be inspected in accordance

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with § 11.21. The horse must be dis- (2) Name and address (including missed from the individual class for street address, post office box, and ZIP which it was to be inspected. code) of the horse trainer. (e) Appeals. The HIO must provide a (3) Name and address (including process in its rulebook for alleged vio- street address, post office box, and ZIP lators to appeal penalties. The process code) of the carrier transporting the must be approved by the Department. horse, and of the driver of the means of For all appeals, the appeal must be conveyance used. granted and the case heard and decided by the HIO or the violator must begin (4) Origin of the shipment and date serving the penalty within 60 days of thereof, and, the date of the violation. The HIO must (5) Destination of shipment. submit to the Department all decisions (b) [Reserved] on penalty appeals within 30 days of (Approved by the Office of Management and the completion of the appeal. When a Budget under control number 0579–0056) penalty is overturned on appeal, the HIO must also submit evidence com- [44 FR 25179, Apr. 27, 1979, as amended at 48 posing the record of the HIO’s decision FR 57471, Dec. 30, 1983; 56 FR 13750, Apr. 4, on the appeal. 1991] (f) Departmental prosecution. The De- partment retains the authority to ini- § 11.41 Reporting required of horse industry organizations or associa- tiate enforcement proceedings with re- tions. spect to any violation of the Act, including violations for which penalties Each horse industry organization or are assessed in accordance with this association which sponsors, or which section, and to impose the penalties sanctions any horse show, horse exhi- authorized by the Act if the Depart- bition, or horse sale or auction, shall ment determines that such actions are furnish the Department 6 by March 1 of necessary to fulfill the purpose of the each year with all such organization or Act and this part. In addition, the De- association rulebooks, and disciplinary partment reserves the right to inform procedures for the previous year per- the Attorney General of any violation taining to violations of the Horse Pro- of the Act or of this part, including tection Act or regulations, applicable violations for which penalties are as- to such horse show, horse exhibition, sessed in accordance with this section. or horse sale or auction. Rulebooks and [77 FR 33618, June 7, 2012] information relating to disciplinary procedures for violations of the Horse § 11.40 Prohibitions and requirements Protection Act or regulations should concerning persons involved in be readily available to all exhibitors, transportation of certain horses. trainers, and owners of horses at such (a) Each person who ships, trans- show, exhibition, sale, or auction. Each ports, or otherwise moves, or delivers horse industry organization or associa- or receives for movement, any horse tion shall furnish the Department 6 with reason to believe such horse may with a quarterly report of all discipli- be shown, exhibited, sold or auctioned nary actions taken against the man- at any horse show, horse exhibition, or agement or any horse show, horse exhi- horse sale or auction, shall allow and assist in the inspection of such horse at bition, horse sale, or horse auction, any such show, exhibition, sale, or auc- any exhibitor, or any licensed DQP, for tion to determine compliance with the violation of the Horse Protection Act Act as provided in § 11.4 of the regula- or regulations, and the results thereof. tions and shall furnish to any APHIS (Approved by the Office of Management and representatives upon his request the Budget under control number 0579–0056) following information: (1) Name and address (including [44 FR 25179, Apr. 27, 1979, as amended at 48 street address, post office box, and ZIP FR 57471, Dec. 30, 1983] code) of the horse owner and of the shipper, if different from the owner or trainer. 6 See footnote 6 to § 11.7.

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PART 12—RULES OF PRACTICE Subpart B—Supplemental Rules of GOVERNING PROCEEDINGS Practice UNDER THE HORSE PROTECTION ACT § 12.10 Stipulations. (a) At any time prior to the issuance Subpart A—General of a complaint seeking a civil penalty Sec. under the Act, the Administrator, in 12.1 Scope and applicability of rules of prac- his discretion, may enter into a stipu- tice. lation with any person in which: (1) The Administration gives notice Subpart B—Supplemental Rules of Practice of an apparent violation of the Act or 12.10 Stipulations. the regulations issued thereunder by AUTHORITY: 15 U.S.C. 1825 and 1828; 7 CFR such person and affords such person an 2.22, 2.80, and 371.7. opportunity for a hearing regarding the matter as provided by the Act; Subpart A—General (2) Such person expressly waives hearing and agrees to a specified order § 12.1 Scope and applicability of rules including an agreement to pay a speci- of practice. fied civil penalty within a designated The Uniform Rules of Practice for time; and the Department of Agriculture promul- (3) The Administrator agrees to ac- gated in subpart H of part 1, subtitle A, cept the specified order including a title 7, Code of Federal Regulations, civil penalty in settlement of the par- are the Rules of Practice applicable to ticular matter involved if it is paid adjudicatory, administrative pro- within the designated time. ceedings under section 6(a) of the Horse (b) If the specified penalty is not paid Protection Act of 1970 (15 U.S.C. within the time designated in such a 1825(a)) and sections 6 (b) and (c) of the Horse Protection Act (15 U.S.C. 1825 (b) stipulation, the amount of the stipu- and (c)). In addition, the Supplemental lated penalty shall not be relevant in Rules of Practice set forth in subpart B any respect to the penalty which may of this part shall be applicable to such be assessed after issuance of a com- proceedings. plaint. [42 FR 10959, Feb. 25, 1977, as amended at 68 [42 FR 10960, Feb. 25, 1977, as amended at 68 FR 6342, Feb. 7, 2003] FR 6342, Feb. 7, 2003]

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PART 49—RULES OF PRACTICE Subpart B—Supplemental Rules of GOVERNING PROCEEDINGS Practice UNDER CERTAIN ACTS § 49.10 Stipulations. Subpart A—General (a) At any time prior to the issuance of a complaint seeking a civil penalty Sec. under any of the Acts listed in § 49.1, 49.1 Scope and applicability of rules of prac- the Administrator, in his discretion, tice. may enter into a stipulation with any person in which: Subpart B—Supplemental Rules of Practice (1) The Administrator or the Admin- 49.10 Stipulations. istrator’s delegate gives notice of an apparent violation of the applicable AUTHORITY: 7 U.S.C. 8301–8317; 7 CFR 2.22, Act, or the regulations issued there- 2.80, and 371.4. under, by such person and affords such SOURCE: 48 FR 30094, June 30, 1983, unless person an opportunity for a hearing re- otherwise noted. garding the matter as provided by such Act; Subpart A—General (2) Such person expressly waives hearing and agrees to pay a specified § 49.1 Scope and applicability of rules penalty within a designated time; and of practice. (3) The Administrator agrees to accept the penalty in settlement of the The Uniform Rules of Practice for particular matter involved if the pen- the Department of Agriculture promul- alty is paid within the designated time. gated in subpart H of part 1, subtitle A, (b) If the penalty is not paid within title 7, Code of Federal Regulations, the time designated in such a stipula- are the Rules of Practice applicable to tion, the amount of the stipulated pen- adjudicatory, administrative pro- alty shall not be relevant in any re- ceedings under the following statutory spect to the penalty which may be as- provisions: sessed after issuance of a complaint. Act of May 29, 1884, commonly known as the Animal Industry Act, section 7, as amend- PART 50—ANIMALS DESTROYED ed (21 U.S.C. 117), BECAUSE OF TUBERCULOSIS Act of February 2, 1903, commonly known as the Cattle Contagious Diseases Act of 1903, Sec. section 3, as amended (21 U.S.C. 122), 50.1 Definitions. Act of March 3, 1905, Section 6, as amended (21 U.S.C. 127), Subpart A—General Indemnity Act of July 2, 1962, section 6(a), as amended (21 U.S.C. 134e). 50.2 Applicability of this subpart; cooperation with States. The Animal Health Protection Act (7 U.S.C. 50.3 Payment to owners for animals de- 8301 et seq.) stroyed. In addition, the Supplemental Rules of 50.4 Classification of cattle, bison, captive cervids, and other livestock as infected, Practice set forth in subpart B of this exposed, or suspect. part shall be applicable to such pro- 50.5 Record of tests. ceedings. 50.6 Identification of animals to be destroyed because of tuberculosis. [48 FR 30094, June 30, 1983, as amended at 68 50.7 Destruction of animals. FR 6342, Feb. 7, 2003] 50.8 Payment of expenses for transporting and disposing of infected, exposed, and suspect animals. 50.9 Appraisals. 50.10 Report of appraisals.

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50.11 Report of salvage proceeds. family Cervidae raised or maintained 50.12 Claims for indemnity. in captivity for the production of meat 50.13 Disinfection of premises, conveyances, and other agricultural products, for and materials. 50.14 Claims not allowed. sport, or for exhibition, including time 50.15–50.16 [Reserved] such animals are moved interstate; or any wild cervid that is moved inter- Subpart B—Dairy Cattle and Facilities in state, during the period of time from the El Paso, Texas, Region capture until release into the wild. A captive cervid that escapes will con- 50.17 Payment. 50.18 Identification and disposal of cattle. tinue to be considered a captive cervid 50.19 Report of salvage proceeds. as long as it bears an official eartag or 50.20 Claims for payment. other identification approved by the 50.21 Schedule of payments. Administrator as unique and traceable 50.22 Claims not allowed. with which to trace the animal back to AUTHORITY: 7 U.S.C. 8301–8317; 7 CFR 2.22, its herd of origin. 2.80, and 371.4. Department. The United States De- SOURCE: 40 FR 27009, June 26, 1975, unless partment of Agriculture. otherwise noted. Designated tuberculosis epidemiologist (DTE). A State or Federal epidemiolo- § 50.1 Definitions. gist designated by the Administrator For the purposes of this part, the fol- to make decisions concerning the use lowing terms mean: and interpretation of diagnostic tests Accredited veterinarian. A veteri- for tuberculosis and the management narian approved by the Administrator of tuberculosis affected herds. A DTE in accordance with the provisions of has the responsibility to determine the part 161 of this title to perform func- scope of epidemiologic investigations, tions specified in parts 1, 2, 3, and 11 of determine the status of animals and subchapter A, and subchapters B, C, herds, assist in the development of in- and D of this chapter, and to perform dividual herd plans, and coordinate dis- functions required by cooperative ease surveillance and eradication pro- State-Federal disease control and grams within the geographic area of eradication programs. the DTE’s responsibility. Administrator. The Administrator, Destroyed. Condemned under State Animal and Plant Health Inspection authority and destroyed by slaughter Service, or any person authorized to or by death otherwise. act for the Administrator. Animal and Plant Health Inspection Heifer. A female dairy cow that has Service. The Animal and Plant Health not given birth. Inspection Service of the United States Herd. Except for livestock assembled Department of Agriculture (APHIS). at feedlots, any group of livestock APHIS representative. A veterinarian maintained for at least 4 months on or other person employed by APHIS in common ground for any purpose, or animal health activities, who is au- two or more groups of livestock under thorized to perform the function in- common ownership or supervision, geo- volved. graphically separated but that have an Approved herd plan. A herd manage- interchange or movement of livestock ment and testing plan based on the dis- without regard to health status, as de- ease history and movement patterns of termined by the Administrator. an individual herd, designed by the Herd depopulation. Removal by herd owner and a State representative slaughter or other means of destruc- or APHIS representative to determine tion of all cattle, bison, and captive the disease status of livestock in the cervids in a herd, as well as any other herd and to eradicate tuberculosis exposed livestock in the herd, prior to within the herd. The plan must be restocking with new livestock. jointly approved by the State animal Livestock. Cattle, bison, captive health official and the Veterinarian in cervids, swine, dairy goats, and other Charge. hoofed animals (such as llamas, al- Captive cervid. All species of deer, elk, pacas, and antelope) raised or main- moose, and all other members of the tained in captivity for the production

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of meat and other products, for sport, State. Any State, territory, the Dis- or for exhibition. trict of Columbia, or Puerto Rico. Milking cow. A female dairy cow that State animal health official. The indi- has given birth and is being used for vidual employed by a State who is re- milk production. sponsible for livestock and poultry dis- Mortgage. Any mortgage, lien or ease control and eradication programs other security or interest that is rein that State. corded under State law or identified in State representative. A veterinarian or the indemnity claim form filed under other person who is employed in live- § 50.12 and held by any person other stock sanitary work of a State or a po- than the one claiming indemnity. litical subdivision of a State and who is Net salvage. The amount received for authorized by the State or political animals destroyed because of tuber- subdivision to perform the function in- culosis, after deducting freight, truck- volved under a memorandum of under- ing, yardage, commission, slaughtering standing with the Department. charges, and similar costs to the Tuberculosis. The contagious, infec- owner. tious, and communicable disease Owner. Any person who has a legal or rightful title to livestock whether or caused by Mycobacterium bovis. not they are subject to a mortgage. Veterinarian in Charge. The veteri- Permit. A permit for movement of nary official of APHIS who is assigned livestock directly to slaughter, listing by the Administrator to supervise and the disease status and identification of perform official animal health work of the animal, where consigned, cleaning APHIS in the State concerned. and disinfection requirements, and [40 FR 27009, June 26, 1975, as amended at 45 proof of slaughter certification. FR 32287, May 16, 1980; 51 FR 33735, Sept. 23, Person. Any individual, corporation, 1986; 52 FR 1317, Jan. 13, 1987; 52 FR 39614, company, association, firm, partner- Oct. 23, 1987; 56 FR 36998, Aug. 2, 1991; 58 FR ship, society, or joint stock company, 34698, June 29, 1993; 60 FR 37808, July 24, 1995; or any organized group of any of the 63 FR 34263, June 24, 1998; 63 FR 72122, Dec. foregoing. 31, 1998; 67 FR 7590, Feb. 20, 2002; 67 FR 48750, Quarantined feedlot. A confined area July 26, 2002] under the direct supervision and control of a State livestock official who Subpart A—General Indemnity shall establish procedures for the accounting of all livestock entering or § 50.2 Applicability of this subpart; co- leaving the area. The quarantined feed- operation with States. lot shall be maintained for finish feed- (a) The provisions of this subpart ing of livestock in drylot with no pro- apply to all payments made by the De- vision for pasturing and grazing. All partment for the destruction of ani- livestock leaving such feedlot must mals because of tuberculosis, except as only move directly to slaughter in ac- specifically provided in subpart B of cordance with established procedures this part. for handling quarantined livestock. (b) The Administrator cooperates Reactor cattle, bison, and captive with the proper State authorities in cervids. Cattle, bison, and captive the eradication of tuberculosis and cervids are classified as reactors for tu- pays Federal indemnities for the de- berculosis in accordance with the struction of cattle, bison, captive ‘‘Uniform Methods and Rules Bovine cervids, or swine affected with or ex- Tuberculosis Eradication,’’ based on a posed to tuberculosis. positive response to an official tuberculin test. [67 FR 48751, July 26, 2002] Registered livestock. Livestock for which individual records of ancestry § 50.3 Payment to owners for animals are maintained, and for which indi- destroyed. vidual registration certificates are (a) The Administrator is authorized issued and recorded by a recognized to agree on the part of the Department breed association whose purpose is the to pay indemnity to owners of the fol- improvement of the breed. lowing animals:

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(1) Cattle, bison, or captive cervids (c) Cattle and bison are classified as destroyed because the animals are in- suspects for tuberculosis based on a fected with or exposed to tuberculosis; positive response to an official tuber- (2) Cattle, bison, or captive cervids culin test, in accordance with the that have been classified as suspect for ‘‘Uniform Methods and Rules—Bovine tuberculosis, except that the payment Tuberculosis Eradication’’ (incor- of indemnity for the destruction of sus- porated into the regulations by ref- pect cattle, bison, and captive cervids erence in part 77). Captive cervids are will be withheld until the tuberculosis classified as suspects for tuberculosis status of the suspect animal has been in the same manner as cattle and determined and, if the cattle, bison, or bison. captive cervid is found to be infected (d) The designated tuberculosis epi- with tuberculosis, until all cattle, demiologist will determine whether bison, and captive cervids 12 months of livestock other than cattle, bison, or age or older in the claimant’s herd captive cervids are classified as ex- have been tested for tuberculosis under posed to tuberculosis by reason of asso- APHIS or State supervision; and ciation with an affected herd of cattle, (3) Other livestock destroyed because bison, or captive cervids. they are classified as exposed to tuber- [40 FR 27009, June 26, 1975, as amended at 52 culosis by the designated tuberculosis FR 39614, Oct. 23, 1987; 56 FR 36998, Aug. 2, epidemiologist by reason of an associa- 1991; 60 FR 37809, July 24, 1995; 63 FR 34264, tion with an affected herd of cattle, June 24, 1998; 67 FR 7591, Feb. 20, 2002] bison, or captive cervids. (b) In each case, the joint State-Fed- § 50.5 Record of tests. eral indemnity paid, together with the When any cattle, bison, or captive amount for net salvage the owner re- cervid in a herd is classified by an ceives, may not exceed the appraised APHIS or State representative or ac- value of the animal, as determined in credited veterinarian as a reactor to a accordance with § 50.9. Additionally, test for tuberculosis, a complete test the Department will in no case pay record shall be made for such herd, in- more than $3,000 for an animal that is cluding the reactor tag number of each destroyed. reacting animal and the registration [67 FR 7591, Feb. 20, 2002] name and number of each reacting registered animal. VS Form 6–22 or an § 50.4 Classification of cattle, bison, equivalent State form shall be used for captive cervids, and other livestock the record of any herd having any reac- as infected, exposed, or suspect. tor to a tuberculin test. A copy of the (a) Cattle, bison, and captive cervids applicable test record shall be given to are classified as infected with tuber- the owner of any such herd, and one culosis on the basis of an intradermal copy of each such record shall be fur- tuberculin test applied by a Federal, nished to the appropriate State veteri- State, or an accredited veterinarian or narian’s office. by other diagnostic procedure approved [40 FR 27009, June 26, 1975, as amended at 52 in advance by the Administrator. FR 39614, Oct. 23, 1987; 56 FR 36998, Aug. 2, (b) Cattle, bison, and captive cervids 1991; 60 FR 37809, July 24, 1995; 63 FR 34264, are classified as exposed to tuber- June 24, 1998] culosis when such cattle, bison, and captive cervids (1) are part of a known § 50.6 Identification of animals to be infected herd, or (2) are found to have destroyed because of tuberculosis. moved from an infected herd before the (a) Livestock to be destroyed because time infection was disclosed in such of tuberculosis must be identified as herd and after the time such herd had follows: apparently become infected, or (3) are (1) Livestock classified as reactors found to have been exposed by virtue of for tuberculosis must be identified nursing a reactor dam: Provided, That within 15 days after being classified as cattle, bison, and captive cervids clas- reactors, except that the veterinarian sified as exposed to tuberculosis shall in charge may extend the time limit be removed direct to slaughter. for identification to 30 days when he or

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she receives a request for such an ex- credited veterinarian, or an individual tension prior to the expiration date of authorized for this purpose by an the original 15-day period allowed and APHIS representative. circumstances beyond the control of (d) Other exposed livestock. Livestock the owner warrant such an extension, other than cattle, bison, or captive and the Administrator may extend the cervids that are destroyed under the time limit for identification beyond 30 provisions of § 50.3 must be identified days upon request in specific cases by tagging with a serially numbered when circumstances beyond the control metal eartag attached to either ear. of the owner warrant such an exten- All such animals to be destroyed must sion. be transported to the place of destruc- (2) Livestock other than reactors for tion in vehicles closed with seals pro- tuberculosis that are to be destroyed vided by APHIS or shall be accom- because of tuberculosis must be identi- panied to the place of destruction by fied prior to movement from the premises of origin to the place of destruc- an APHIS or State representative: Pro- tion. vided, however, that animals destroyed (b) Reactor cattle, bison, and captive and disposed of under the direct super- cervids. Reactor cattle, bison, and cap- vision of an APHIS or State represent- tive cervids must be identified by ative on the premises where they were branding the letter ‘‘T,’’ at least 5 by 5 exposed do not require individual iden- centimeters (2 by 2 inches) in size, high tification. on the left hip near the tailhead and by [67 FR 7591, Feb. 20, 2002] attaching to the left ear an approved metal eartag bearing a serial number § 50.7 Destruction of animals. and the inscription ‘‘U.S. Reactor,’’ or a similar State reactor tag. Reactor (a) Slaughter or disposal. Livestock to cattle, bison, and captive cervids may be destroyed because of tuberculosis be moved interstate to slaughter with- must be shipped direct to slaughter out branding if they are permanently under permit to a Federal or State in- identified by the letters ‘‘TB’’ tattooed spected slaughtering establishment or legibly in the left ear, they are sprayed be disposed of by rendering, burial, or on the left ear with yellow paint, and incinerating in an approved manner they are either accompanied by an under supervision of an APHIS or State APHIS or State representative or employee. moved directly to slaughter in vehicles (b) Time limit for destruction of ani- closed with official seals. The official mals. Livestock for which Federal in- seals must be applied and removed by demnity may be paid because of tuber- an APHIS representative, State rep- culosis must be destroyed and carcass resentative, accredited veterinarian, or disposal completed within 15 days after an individual authorized for this pur- the date of appraisal, except that the pose by an APHIS representative. appropriate Veterinarian in Charge, for (c) Exposed cattle, bison, and captive reasons satisfactory to him, may ex- cervids. Exposed cattle, bison, and cap- tend the time limit for slaughter to 30 tive cervids must be identified by days when request for such extension is branding the letter ‘‘S,’’ at least 5 by 5 received by him prior to the expiration centimeters (2 by 2 inches) in size, high of the original 15-day period allowed, on the left hip near the tailhead and by and the Administrator may extend the attaching to either ear an approved time limit for slaughter beyond 30 metal eartag bearing a serial number. days, upon request in specific cases and Exposed cattle, bison, and captive for reasons satisfactory to him. cervids may be moved interstate to slaughter without branding if they are (Approved by the Office of Management and either accompanied by an APHIS or Budget under control number 0579–0051) State representative or moved directly [40 FR 27009, June 26, 1975, as amended at 45 to slaughter in vehicles closed with of- FR 32287, May 16, 1980; 52 FR 39614, Oct. 23, ficial seals. The official seals must be 1987; 56 FR 36998, Aug. 2, 1991; 60 FR 37809, applied and removed by an APHIS rep- July 24, 1995; 63 FR 34264, June 24, 1998; 67 FR resentative, State representative, ac- 7591, Feb. 20, 2002]

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§ 50.8 Payment of expenses for trans- by the owner of the animals, the owner porting and disposing of infected, will have 15 days from the receipt of exposed, and suspect animals. the appraisal to submit to the Admin- The Department may pay, when ap- istrator a request for a review of the proved in advance in writing by the appraisal, along with the reasons why Veterinarian in Charge, one half the the animals should be appraised at a expenses of transporting infected, ex- higher value. The decision by the Ad- posed, or suspect livestock to slaughter ministrator regarding the value of the or to the point where disposal will take animals is final. place, and one half the expenses of de- (c) When livestock to be destroyed stroying, burying, incinerating, ren- because of tuberculosis are appraised, dering, or otherwise disposing of in- due consideration will be given to their fected, exposed, or suspect livestock; breeding value as well as to their dairy Provided that, the Department may pay or meat value. Livestock presented for more than one-half of the expenses payment as registered must be accom- when the Administrator determines panied by their registration papers. If that doing so will contribute to the tu- the registration papers are temporarily berculosis eradication program. For re- not available, or if the livestock are imbursement to be made, the owner of less than 3 years old and unregistered, the animals must present the Veteri- the veterinarian in charge may grant a narian in Charge with a copy of either reasonable time for the presentation of a receipt for expenses paid or a bill for their registration papers. services rendered. Any bill for services rendered by the owner must not be [67 FR 7591, Feb. 20, 2002] greater than the normal fee for similar § 50.10 Report of appraisals. services provided by a commercial hauler or renderer. Appraisals of livestock made in accordance with § 50.9 shall be recorded [62 FR 49592, Sept. 23, 1997; as amended at 63 on forms furnished by APHIS. The ap- FR 34264, June 24, 1998; 67 FR 7591, Feb. 20, praisal form shall be signed by the ap- 2002] praiser and by the owner certifying his § 50.9 Appraisals. acceptance of the appraisal. The ‘‘date of appraisal’’ shall be the date that the (a) Livestock to be destroyed because owner signs the appraisal form. The of tuberculosis under § 50.3 must be ap- original of the appraisal form and as praised within 15 days after being classified as infected with tuberculosis, ex- many copies thereof as may be required cept that the veterinarian in charge for APHIS, the State, and the owner of may extend the time limit for ap- the animals shall be sent to the appro- praisal to 30 days when he or she re- priate Veterinarian in Charge. ceives a request for such an extension [40 FR 27009, June 26, 1975, as amended at 52 before the end of the expiration date of FR 39614, Oct. 23, 1987; 56 FR 36998, Aug. 2, the original 15-day period allowed and 1991; 60 FR 37809, July 24, 1995; 63 FR 34264, circumstances beyond the control of June 24, 1998; 67 FR 7592, Feb. 20, 2002] the owner warrant such an extension, and the Administrator may extend the § 50.11 Report of salvage proceeds. time limit for appraisal beyond 30 days A report of the salvage derived from upon request in specific cases when cir- the sale of each animal on which a cumstances beyond the control of the claim for indemnity may be made owner warrant such an extension. under the provisions of § 50.3 shall be (b) Animals for which indemnity is to made on a salvage form acceptable to be paid under this part must be ap- APHIS which shall be signed by the praised at their fair market value by purchaser or his agent or by the selling an appraiser selected by APHIS. APHIS agent handling the animals. If the live- may decline to accept any appraisal stock are sold by the pound, the sal- that appears to it to be unreasonable vage form shall show the weight, price or out of proportion to the value of like per pound, gross receipts, expenses if animals of a like quality. Should the any, and net proceeds. If the livestock appraisal made by the appraiser se- are not sold on a per pound basis, the lected by APHIS be deemed inadequate net purchase price of each animal must

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be stated on the salvage form and an the APHIS indemnity claim form has explanation showing how the amount been approved by a proper State offi- was arrived at must be submitted. In cial and if payment of the claim has the event the animals are not disposed been recommended by the appropriate of through regular slaughterers or Veterinarian in Charge or an official through selling agents, the owner shall designated by him. On claims for in- furnish, in lieu of the salvage form, an demnity made under the provisions of affidavit showing the amount of sal- § 50.3, the Veterinarian in Charge or of- vage obtained by him and shall certify ficial designated by him shall record on that such amount is all that he has re- the APHIS indemnity claim form the ceived or will receive as salvage for amount of Federal and State indem- said animals. In an emergency, a cer- nity payments that appear to be due to tificate executed by the appropriate the owner of the animals. The owner of Veterinarian in Charge will be accept- the animals shall be furnished a copy able in lieu of the owner’s affidavit. of the APHIS indemnity claim form. The salvage shall be considered to be The Veterinarian in Charge or official the net amount received for an animal designated by him shall then forward after deducting freight, truckage, yard- the APHIS indemnity claim form to age, commission, slaughtering charges, the appropriate official for further ac- and similar costs. The original of the tion on the claim. No charges for hold- salvage form or the affidavit of the ing the livestock on the farm pending owner or certificate of the appropriate slaughter or for trucking by the owner Veterinarian in Charge, furnished in shall be so deducted or otherwise paid lieu thereof, shall be furnished to the by the Department. Veterinarian in charge if it is not already in his possession. Additional cop- [40 FR 27009, June 26, 1975, as amended at 52 ies may be furnished to the State offi- FR 39614, Oct. 23, 1987; 56 FR 36998, Aug. 2, cials, if required. Destruction of live- 1991; 60 FR 37809, July 24, 1995; 63 FR 34264, June 24, 1998; 67 FR 7592, Feb. 20, 2002] stock by burial, incineration or other disposal of carcasses shall be super- § 50.13 Disinfection of premises, con- vised by an APHIS or State representa- veyances, and materials. tive who shall prepare and transmit to the Veterinarian in Charge a report All premises, including all struc- identifying the animals and showing tures, holding facilities, conveyances, the disposition thereof. or materials which are determined by the appropriate Veterinarian in Charge (Approved by the Office of Management and to constitute a health hazard to hu- Budget under control number 0579–0001) mans or animals because of tuber- [40 FR 27009, June 26, 1975, as amended at 48 culosis shall be properly cleaned and FR FR 57471, Dec. 30, 1983; 52 FR 39614, Oct. disinfected, in accordance with proce- 23, 1987; 56 FR 36998, Aug. 2, 1991; 60 FR 37809, dures approved by the Department, July 24, 1995; 63 FR 34264, June 24, 1998; 67 FR within 15 days after the removal of tu- 7592, Feb. 20, 2002] berculosis infected or exposed livestock § 50.12 Claims for indemnity. except that the Veterinarian in Charge, for reasons satisfactory to him, may Claims for Federal indemnity for extend the time limit for disinfection livestock destroyed because of tuber- to 30 days when request for such exten- culosis shall be presented on indemnity sion is received by him prior to the ex- claim forms furnished by APHIS on piration date of the original 15-day pe- which the owner of the animals covered riod allowed. thereby shall certify that the animals are or are not, subject to any mortgage [40 FR 27009, June 26, 1975, as amended at 52 as defined in this Part. If the owner FR 39614, Oct. 23, 1987; 60 FR 37809, July 24, states there is a mortgage, the APHIS 1995; 67 FR 7592, Feb. 20, 2002] indemnity claim form shall be signed by the owner and by each person hold- § 50.14 Claims not allowed. ing a mortgage on the animals con- Claims for compensation for live- senting to the payment of any indem- stock destroyed because of tuberculosis nity allowed to the person specified will not be allowed in any of the fol- thereon. Payment will be made only if lowing cases:

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(a) The claimant has failed to comply cervids were added to the claimant’s with any of the requirements of this herd. part: (f) For exposed cattle, bison, or cap- (b) All cattle, bison, and captive tive cervids destroyed during herd de- cervids 12 months of age or over in the population, if a designated tuberculosis claimant’s herd have not been tested epidemiologist has determined that for tuberculosis under APHIS or State other livestock in the herd have been supervision: Provided, however, that exposed to tuberculosis by reason of as- cattle, bison, and captive cervids de- sociation with tuberculous livestock, stroyed because of tuberculosis are ex- and those other livestock determined empt from this testing requirement if to have been exposed to tuberculosis the cattle, bison, and captive cervids have not been destroyed. are subjected to a postmortem exam- (g) For livestock other than cattle, ination for tuberculosis by a Federal or bison, and captive cervids that are de- State veterinarian. stroyed because of association with (c) There is substantial evidence that herds of affected cattle, bison, or cap- the owner of the animals or the agent tive cervids: of the owner has in any way been re- (1) If the livestock did not reside sponsible for any attempt to obtain in- among the herd for a period of 4 demnity funds for the animals unlaw- months or more; fully or improperly. (2) If the livestock have not received (d) At the time the cattle, bison, or a postmortem examination for tuber- captive cervids in the claimant’s herd culosis; or were tested for tuberculosis, the cattle, (3) If the livestock were added to a bison, captive cervids, or other live- herd that was under quarantine for tuberculosis at the time the livestock stock in the herd belonged to or were were added to the herd, unless an ap- on the premises of any person to whom proved herd plan was in effect at that they had been sold, shipped, or deliv- time. ered for slaughter unless or until all of the cattle, bison, captive cervids, and [67 FR 7592, Feb. 20, 2002] other livestock remaining on the premises or in the herd from which the test- §§ 50.15–50.16 [Reserved] ed cattle, bison, or captive cervids originated are tested or otherwise ex- Subpart B—Dairy Cattle and Fa- amined for tuberculosis in a manner cilities in the El Paso, Texas, satisfactory to the Administrator or Region his or her designated representative.

(e) If the cattle, bison, or captive SOURCE: 67 FR 48751, July 26, 2002, unless cervids were added to a herd while the otherwise noted. herd was quarantined for tuberculosis, unless an approved herd plan was in ef- § 50.17 Payment. fect at the time the claim was filed. As (a) Eligibility for payment. Owners of part of the approved herd plan, cattle, dairy operations, including owners of bison, or captive cervids added to a dairy cattle and other property used in herd quarantined for tuberculosis connection with a dairy business or must: fluid milk processing plant, are eligible (1) Be from an accredited herd, as de- to receive payment from the Depart- fined in § 77.1 of this chapter; or ment under this subpart in connection (2)(i) Be from a herd that tested nega- with a buffer zone depopulation pro- tive to an official tuberculin test, as gram due to tuberculosis, provided the defined in § 77.1 of this chapter, during owners meet all applicable require- the 60 days before the cattle, bison, or ments of this subpart and the dairy captive cervids were added to the cattle herd is within the area cir- claimant’s herd; and cumscribed by the following bound- (ii) Have been found negative to an aries: Beginning at the point where the official tuberculin test, as defined in Hudspeth-El Paso County line inter- § 77.1 of this chapter, during the 60 days sects U.S. Highway 62; then west along before the cattle, bison, or captive U.S. Highway 62 to the El Paso Toll

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Bridge; then southeast along the Rio APHIS officials with the opportunity Grande River to the Fort Hancock-El to monitor and evaluate the removal Porvenir Bridge; then northeast along operations; and spur 148 to Interstate 10; then north- (7) Such other terms, provisions, and west along Interstate 10 to the conditions as agreed by each owner and Hudspeth-El Paso County line; then APHIS. north along the Hudspeth-El Paso (c) Amount of payment for cattle and County line to the point of beginning. other property. Upon approval of a (b) To be eligible for payment, each claim submitted in accordance with of the owners of dairy cattle and other § 50.20 of this subpart, owners eligible property within the area described in for payments under paragraph (a) of paragraph (a) of this section must sign this section will receive payments for and adhere to an agreement with cattle and other property, the amount APHIS to do the following: of which is determined by the following (1) Cease all dairy cattle operations rates: within the described area and dispose (1) For milking cows, an amount not of all sexually intact cattle on the to exceed $2,922 per animal; and dairy operation premises no later than (2) For heifers, an amount not to ex- 3 years after all eligible owners have ceed $834 per animal. signed their respective agreements; (d) Any dairy cattle added to a prem- (2) Conduct no dairy farming or other ises after the date an owner has signed dairy activity, including the rearing of the agreement required under para- breeding cattle, but not including the graph (b) of this section will not be in- grazing or feeding of steers and spayed cluded in the rate calculation in para- heifers intended for terminal market, graph (c) of this section and must be within the area described in paragraph disposed of within 3 years after all eli- (a) of this section until the described gible owners have signed their respec- area and the adjoining area of Mexico tive agreements. have been declared free of bovine tu- (e) Amount of payment for certain other berculosis, as determined property. In addition to the amounts epidemiologically by APHIS, but in paid under paragraph (c) of this sec- any event for a period of not less than tion, amounts will be paid as follows: 20 years after all eligible owners have (1) For expenses in relocating equip- signed their respective agreements. ment of a reverse osmosis plant in El (3) Allow a covenant to be placed on Paso County, TX, an amount equal to their properties where dairy operations the costs of relocating the plant’s have been conducted that will prevent equipment, not to exceed $675,000. the establishment of any breeding cat- (2) In conjunction with the perma- tle operations (not including the graz- nent closure of a fluid milk processing ing or feeding of steers and spayed heif- plant in El Paso County, TX, an ers intended for terminal market) on amount not to exceed $950,000, with the premises until the described area payment to be made in the same man- and the adjoining area of Mexico have ner and at the same times, on a pro been declared free of bovine tuber- rata basis, as payments are made to culosis, as determined such owners for their dairy cattle and epidemiologically by APHIS, but in other property. any event for a period of not less than 20 years after all eligible owners have (Approved by the Office of Management and signed their respective agreements. Budget under control number 0579–0193) (4) Maintain responsibility for all [67 FR 48751, July 26, 2002, as amended at 68 cattle on the premises used in the FR 10361, Apr. 4, 2003] dairy operation until those animals are removed from the premises; § 50.18 Identification and disposal of (5) Make all arrangements for the re- cattle. moval of sexually intact cattle from (a) All dairy cattle disposed of under the premises; this subpart must travel from the (6) Notify APHIS officials of the in- premises of origin to their final des- tended removal of all sexually intact tination with an approved metal cattle from the premises and provide eartag, supplied by APHIS or the State

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representative, bearing a serial number mented by an affidavit of the owner and attached to each animal’s left ear. that identifies the animals and de- (b) Dairy cattle disposed of under scribes their disposition. The owner this subpart must be shipped under per- must provide a copy of the affidavit to mit either: the veterinarian in charge within 3 (1) Directly to slaughter at a Federal months of destruction of the animals. or State inspected slaughtering estab- The salvage form, disposal certificate, lishment; or or affidavit will be for information pur- (2) Under permit directly to a live- poses only and will have no effect on stock market and, under the super- the amount of any payment due. vision of an APHIS representative or State representative, through a live- (Approved by the Office of Management and stock market pen that is dedicated to Budget under control number 0579–0193) and marked exclusively for use for animals moved to slaughter, and then di- § 50.20 Claims for payment. rectly to slaughter at a Federal or Claims for payment, other than for State inspected slaughtering establish- reimbursement of relocation expenses ment. of the reverse osmosis dairy plant, (Approved by the Office of Management and must be presented on payment claim Budget under control number 0579–0193) forms furnished by APHIS. 3 On the claim form, the owner must certify § 50.19 Report of salvage proceeds. that the animals or other property are, A report of the salvage derived from or are not, subject to any mortgage. If the sale of each animal for which a the owner states that there is a mort- claim for payment is made under this gage, the claim form must be signed by subpart must be made on a salvage the owner and by each person holding a form acceptable to APHIS that must be signed by the purchaser or by the sell- mortgage on the cattle or other prop- ing agent handling the animals. If the erty, who must agree that the person cattle are sold by the pound, the sal- specified on the claim form may re- vage form must show the weight, price ceive any payment due. The APHIS per pound, gross receipts, expenses if veterinarian in charge or the official any, and net proceeds. If the cattle are designated by him or her will record on not sold on a per-pound basis, the net the claim form the amount of payment purchase price of each animal must be that appears to be due to the owner, stated on the salvage form and an ex- and the owner will be furnished a copy planation showing how the amount was of the APHIS payment claim form. The arrived at must be submitted. In the veterinarian in charge or official des- event the animals are not disposed of ignated by him or her will then forward through regular slaughterers or the APHIS payment claim form to the through selling agents, the owner must appropriate APHIS official for further furnish, in lieu of the salvage form, an action on the claim. The Department affidavit showing the amount of sal- will not pay any costs arising from the vage obtained by him or her and must holding of the cattle pending slaughter, certify that such amount is all he or or for trucking and other transpor- she has received or will receive as sal- tation costs, yardage, commission, vage for the animals. The original of slaughtering charges, or for any other the salvage form or the affidavit of the costs related to having the cattle owner must be furnished to the veteri- slaughtered. The owner of the reverse narian in charge within 3 months of de- osmosis plant must submit copies of struction of the animals, if such document is not already in his or her possession. Disposal of cattle by burial, in- 1,2 [Reserved] cineration, or other means must be su- 3 Claim forms may obtained from the vet- pervised by an APHIS or State rep- erinarian in charge. The location of the veterinarian in charge may be obtained by writ- resentative, who will prepare and ing to National Animal Health Program VS, transmit to the veterinarian in charge APHIS, 4700 River Road Unit 43, Riverdale, a report identifying the animals and MD 20737, or by referring to the local tele- showing their disposition, or be docu- phone book.

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the relevant documentation for reloca- the Administrator, that the claimant tion of equipment to the veterinarian has been responsible for any attempt to in charge. obtain payment funds for such cattle (Approved by the Office of Management and or other dairy property unlawfully or Budget under control number 0579–0193) improperly. § 50.21 Schedule of payments. PART 51—ANIMALS DESTROYED (a) The Department will make pay- BECAUSE OF BRUCELLOSIS ment, other than for reimbursement of relocation expenses of the equipment Subpart A—Indemnity for Cattle, Bison, of the reverse osmosis plant, at 90-day and Swine intervals. The first payment will be made no earlier than 30 days after all Sec. 51.1 Definitions. owners eligible for payment have 51.2 Cooperation with States. signed their agreements required under 51.3 Payment to owners for animals de- § 50.17(b). The Department will deter- stroyed. mine the amount to be paid to each 51.4 Record of tests. owner in each payment by multiplying 51.5 Identification of animals to be de- the total agreement amount for that stroyed because of brucellosis. owner by a fraction that is arrived at 51.6 Destruction of animals; time limit for by dividing the initial census number destruction of animals. 51.7 Claims for indemnity. of dairy cattle for the respective owner 51.8 Disinfection of premises, conveyances, into the number of dairy cattle that and materials. have been removed from the owner’s 51.9 Claims not allowed. herd during that payment period. From 51.10 Part 53 of this chapter not applicable. this amount, 10 percent will be withheld until all animals in the herd have Subpart B—Indemnity for Sheep, Goats, been disposed of and the requirements and Horses of this subpart have been met. The pay- 51.20 Definitions. ments to other property owners will be 51.21 Cooperation with States. determined by multiplying the total 51.22 Payment to owners for goats, sheep, agreement amount for that other prop- and horses destroyed. erty times the same ratio as for the 51.23 Eligibility for indemnity. herd related to that other property, 51.24 Maximum per-head indemnity minus 10 percent. The Department will amounts. make payment for reimbursement of 51.25 Proof of destruction. 51.26 Record of tests. relocation expenses of the reverse os- 51.27 Identification of goats, sheep, and mosis plant within 30 days after the re- horses to be destroyed. location of the plant is completed and 51.28 Moving goats, sheep, and horses to be the owner of the plant has submitted destroyed. to APHIS all documentation of the 51.29 Destruction of animals; time limit. costs of the relocation. 51.30 Claims for indemnity. (b) The Department will not make 51.31 Disinfecting premises, conveyances, final payments until the premises used and materials. for dairy operations have been without 51.32 Claims not allowed. 51.33 Multiple indemnity payments. sexually intact cattle for at least 30 days and until APHIS has inspected AUTHORITY: 7 U.S.C. 8301–8317; 7 CFR 2.22, the premises and has found them to be 2.80, and 371.4. free of manure, except for non-solid areas such as lagoons, and free of all Subpart A—Indemnity for Cattle, feedstuffs that are not in barns, con- Bison, and Swine tainers or feeders. § 51.1 Definitions. § 50.22 Claims not allowed. For the purposes of this part, the fol- The Department will not allow lowing terms shall be construed, re- claims for payment if the claimant has spectively, to mean: failed to comply with any of the re- Accredited veterinarian. A veteri- quirements of this subpart, or there is narian approved by the Administrator substantial evidence, as determined by in accordance with the provisions of

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part 161 of this title to perform func- of permanent incisors (20 months of age tions specified in parts 1, 2, 3, and 11 of or more). subchapter A, and subchapters B, C, Condemn. The determination made by and D of this chapter, and to perform an APHIS representative, State rep- functions required by cooperative resentative, or accredited veterinarian state-federal disease control and eradi- that animals for which indemnity is cation programs. sought under this Part shall be de- Administrator. The Administrator, stroyed. Animal and Plant Health Inspection Dairy cattle. A female bovine of a rec- Service, or any person authorized to ognized dairy breed over 20 months of act for the Administrator. age, which has calved or is within 90 Animal and Plant Health Inspection days of parturition and which is a Service. The Animal and Plant Health member of a dairy herd used to produce Inspection Service of the United States milk for commercial use. Department of Agriculture (APHIS or Destroyed. Condemned under State Service). authority and slaughtered or otherwise Animals. Cattle, bison, and breeding dies. swine. Herd. Any group of animals of the APHIS representative. An individual same species maintained on common employed by APHIS who is authorized ground for any purpose, or two or more to perform the function involved. groups of animals (of the same species) Appraisal. An estimate of the fair under common ownership or super- market value of an animal to be de- vision, geographically separated but stroyed because of brucellosis. The es- which have an interchange or move- timate shall be based upon the meat, ment of animals without regard to dairy, or breeding value of the animal. health status. Brucellosis exposed animal. Except for Herd Depopulation. Removal by a brucellosis reactor animal, any ani- slaughter or other means of destruc- mal that: (1) Is part of or has been in tion of all cattle, bison, or swine in a contact with a herd known to be af- herd or from a specific premises or fected; or (2) has been in contact with under common ownership prior to re- a brucellosis reactor animal for a pe- stocking such premises with new ani- riod of 24 hours or longer; or (3) has mals, except that steers and spayed been in contact with a brucellosis reac- heifers or barrows and gilts maintained tor animal which has aborted, calved for feeding purposes may be retained or farrowed within the past 30 days, or on the premises if the Veterinarian in has a vaginal or uterine discharge. Charge finds such retention to be com- Brucellosis reactor animal. Any animal patible with eradication efforts. The classified as a brucellosis reactor as Veterinarian in Charge may also per- provided in the definition of official mit removal of nonpregnant heifers, test in § 78.1 of this chapter. without payment of indemnity, to Claimant. A person who files a claim Quarantined Feedlots in lieu of imme- for indemnity under § 51.7 for animals diate slaughter. destroyed under this part. Herd known to be affected. Any herd in Complete herd test. An official test for which any animal has been classified as brucellosis (as defined in 9 CFR 78.1) a brucellosis reactor and which has not performed under APHIS supervision in been released from quarantine. a cattle or bison herd on all cattle or Inbred or hybrid swine. Any breeding bison that are (1) 6 months of age or swine which are the progeny of two or more and not official vaccinates, ex- more breeds of registered swine and cept steers and spayed heifers; or (2) which are maintained to produce in- Official calfhood vaccinates of any age bred or hybrid swine, and for which that are parturient or postparturient; records of ancestry exist through or (3) Official calfhood vaccinates of which such swine can be individually beef breeds or bison with the first pair identified as progeny of said registered of permanent incisors fully erupted (2 swine. years of age or more); or (4) Official Mortgage. Any mortgage, lien, or calfhood vaccinates of dairy breeds other security or interest that is re- with partial eruption of the first pair corded under State law or identified in

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the indemnity claim form filed under ican Breed Association, Inc., American § 51.7 and held by any person other than Chianina Association, American Dexter the one claiming indemnity. Cattle Association, American Galloway Official seal. A serially numbered Breeders Association, American metal strip consisting of a self-locking Gelbvieh Association, American Guern- device on one end and a slot on the sey Cattle Club, American Hereford As- other end, which forms a loop when the sociation, American International ends are engaged, which cannot be re- Charolais Association, American used if opened, and is applied by a rep- (International Marchigiana Society, resentative of the Veterinarian in American Jersey Cattle Club, Amer- Charge or the State animal health official. ican Maine-Anjou Association, Amer- Owner. Any person who has a legal or ican Milking Shorthorn Society, Amer- rightful title to animals whether or not ican Murray Grey Association, Amer- they are subject to a mortgage. ican Normande Association, American Permit. An official document for Pinzgauer Association, American movement of animals under this sub- Polled Hereford Association, American part issued by an APHIS representa- Red Brangus Association, American tive, state representative, or accred- Red Poll Association, American Salers ited veterinarian listing the disease Association, American Scotch High- status and identification of the animal, land Breeders Association, American where consigned, cleaning and dis- Shorthorn Association, American infecting requirements, and proof of Simmental Association, Inc., American slaughter certification. Tarentaise Asssociation, Ankina Person. Any individual, corporation, Breeders, Inc., Ayrshire Breeders Asso- company, association, firm, partner- ciation, Barzona Breed Association of ship, society, or joint stock company, America, Beefmaster Breeders Uni- or other legal entity. versal, Belted Galloway Society, Recognized slaughtering establishment. Brahmanstein Breeders Association, Any slaughtering establishment oper- Brown Swiss Beef International, Inc., ating under the Federal Meat Inspec- Brown Swiss Cattle Breeders Associa- tion Act (21 U.S.C. 601 et seq.)or a State tion of U.S.A., Char-Swiss Breeders As- meat inspection act. 1 Registered breed association. An asso- sociation, Devon Cattle Association, ciation formed and perpetuated for the Inc., Dutch Belted Cattle Association maintenance of records of purebreeding of America, Inc., Foundation of animal species for a specific breed Beefmaster Association, Galloway Cat- whose characteristics are set forth in tle Society of America, Inc., Galloway Constitutions, By-Laws, and other Performance International, Holstein- rules of the association. The records Friesian Association of America, Inter- maintained by such an association national Braford Association, Inter- shall include an Official Herd Book or national Brangus Breeders Association, other recordkeeping format and Cer- Inc., International Maine-Anjou Asso- tificates of Registration or Recorda- ciation, Marky Cattle Association, Mid tion which identify an animal as a reg- America RX3 Cattle Company, Na- istered animal of that registered breed tional Beefmaster Association, North association. Known registered breed as- American Limousin Foundation, Pan sociations are: American Angus Asso- American Zebu Association, Red and ciation, American Beefalo Association, White Dairy Cattle Association, Red Inc., The American Black Maine-Anjou Angus Association of America, Red Association, American Blonde Poll Beef Breeders International, Red d’Aquitaine Association, American Poll Cattle Club of America, Santa Brahman Breeders Association, Amer- Gertrudis Breeders International, ican Brahmental Association, Amer- Simbrah Association, South Devon Breed Society, Sussex Cattle Associa- 1 A list of recognized slaughtering estab- tion of America, Texas Longhorn lishments is available upon request from the Animal and Plant Health Inspection Service, Breeders Association of America, and 4700 River Road Unit 37, Riverdale, MD 20737– White Park Cattle Association of 1231. America.

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Registered cattle. Cattle for which in- Health Inspection Service, in the State dividual records of ancestry are re- concerned. corded and maintained by a breed asso- [42 FR 64336, Dec. 23, 1977] ciation whose purpose is the improvement of the bovine species, and for EDITORIAL NOTE: For FEDERAL REGISTER ci- which individual registration certifi- tations affecting § 51.1, see the List of CFR cates are issued and recorded by such Sections Affected, which appears in the Finding Aids section of the printed volume breed association. and at www.fdsys.gov. Registered swine. Any breeding swine for which a certificate of pure breeding § 51.2 Cooperation with States. has been issued by a purebred swine as- The Administrator has been dele- sociation. gated the authority to cooperate with Sexually intact exposed female calf. A the proper State authorities in the female bovine less than 6 months of age eradication of brucellosis and to pay that is nursed by a brucellosis reactor indemnities for the destruction of bru- at the time such reactor is condemned, cellosis-reactor animals or brucellosis- and that has not been altered to make exposed animals. it incapable of reproduction. Specifically approved stockyard. Prem- [42 FR 64336, Dec. 23, 1977, as amended at 54 ises approved by the Administrator, in FR 32435, Aug. 8, 1989] accordance with § 71.20 of this chapter, for assembling cattle or bison for sale. 2 § 51.3 Payment to owners for animals destroyed. State. Any State, the District of Co- lumbia, Puerto Rico, the Virgin Islands (a) Cattle and bison. The Adminis- of the United States, Guam, the North- trator may authorize the payment of ern Mariana Islands, or any other terri- Federal indemnity by the U.S. Depart- tory or possession of the United States. ment of Agriculture to any owner State animal health official. The indi- whose cattle or bison are destroyed vidual employed by a State who is re- after having been approved for destruc- sponsible for livestock and poultry dis- tion by APHIS under the brucellosis ease control and eradication programs eradication program. 3 In all cases, the in that State. amount of Federal indemnity will be State representative. An individual em- determined in accordance with the reg- ployed in animal health activities by a ulations in this part that were in effect State or a political subdivision thereof, on the date that reactors were found or and who is authorized by such State or the date that whole-herd depopulation political subdivision to perform the or destruction of individual animals function involved under a cooperative was approved. Prior to payment of in- agreement with the United States De- demnity, proof of destruction 4 must be partment of Agriculture. Unofficial vaccinate. Any cattle or 3 The Administrator shall authorize pay- bison which have been vaccinated for ment of Federal indemnity by the U.S. De- brucellosis other than in accordance partment of Agriculture at the maximum with the provisions for official vac- per-head rates in § 51.3: (a) As long as suffi- cinates set forth in § 78.1 of this chap- cient funds appropriated by Congress appear to be available for this purpose for the re- ter. mainder of the fiscal year; (b) in States or Veterinarian in Charge. The veteri- areas not under Federal quarantine; (c) in nary official of the Animal and Plant States requesting payment of Federal indem- Health Inspection Service, United nity; and (d) in States not requesting a lower States Department of Agriculture, who rate. is assigned by the Administrator to su- 4 The Veterinarian in Charge shall accept pervise and perform offical animal any of the following documents as proof of destruction: (a) A postmortem report; (b) a health work of the Animal and Plant meat inspection certification of slaughter; (c) a written statement by a State represent- 2 Notices containing lists of specifically ap- ative, APHIS representative, or accredited proved stockyards are published in the FED- veterinarian attesting to the destruction of ERAL REGISTER. Lists of specifically ap- the animal; (d) a written, sworn statement proved stockyards also may be obtained from by the owner or caretaker of the animal at- the State animal health official, State rep- testing to the destruction of the animal; (e) resentatives, or APHIS representatives. Continued

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furnished to the Veterinarian in described in paragraphs (a)(2)(ii)(A) and Charge. (a)(2)(ii)(B) of this section, involving (1) Eligibility for indemnity. Owners of fair market value of the animal to be the following types of animals de- destroyed or a fixed rate, for deter- stroyed because of brucellosis are eligi- mining the maximum amounts of in- ble to receive Federal indemnity for demnity they may receive. 3 The meth- their animals: od chosen must be used for all animals (i) Cattle and bison identified as re- to be destroyed. Owners have the op- actors as a result of a complete herd tion of having an appraisal done prior test and any sexually intact exposed fe- to choosing the method used. Apprais- male calves; als will be conducted by an inde- (ii) Cattle and bison in a herd that pendent appraiser selected by the Ad- has been approved for depopulation; ministrator. The cost of the appraisals and will be borne by APHIS. (iii) Brucellosis-exposed cattle and (A) Appraisal method. Each eligible brucellosis-exposed bison that were animal will be appraised to determine previously sold or traded from any herd its fair market value. The indemnity that was, subsequent to the sale or shall be the appraised value, minus the trade, found to be affected with brucel- salvage value. losis. Epidemiological information (B) Fixed-rate method. The indemnity such as test results, herd history, and shall not exceed $250 per animal for related evidence will be used to estab- bison and nonregistered cattle other lish a probable date when the herd was than dairy cattle and $750 per animal first affected with brucellosis. Animals for registered cattle and nonregistered sold after that date will be considered dairy cattle. to be exposed; those sold before that (b) Swine—(1) Brucellosis reactor swine. date will not. The Administrator may authorize 3 the (2) Maximum per-head indemnity payment of Federal indemnity by the amounts. Owners of the types of ani- United States Department of Agri- mals described in § 51.3(a)(1) are eligible culture to an owner whose breeding to receive Federal indemnity for their swine are destroyed as brucellosis reac- animals in the following amounts: tors. The indemnity shall not exceed (i) Brucellosis reactors and sexually in- $25 per head for registered, inbred, or tact exposed female calves. Except for hybrid swine, or $10 per head for all brucellosis reactors and sexually intact other breeding swine. Prior to payment exposed female calves destroyed as of indemnity, proof of destruction 4 part of a whole-herd depopulation, the shall be furnished to the Veterinarian indemnity for cattle and bison that are in Charge. brucellosis reactors shall not exceed (2) Herd depopulation. The Adminis- $250 for any registered cattle and non- trator may authorize 3 the payment of registered dairy cattle or $50 for any Federal indemnity by the United bison or nonregistered cattle other States Department of Agriculture to than dairy cattle, and the indemnity an owner whose herd of breeding swine for sexually intact exposed female or whose whole herd is destroyed be- calves shall not exceed $50. cause of brucellosis. The indemnity (ii) Herd depopulations and individual shall not exceed $150 per head for reg- exposed animals. Owners of herds that istered, inbred, or hybrid breeding have been approved for depopulation swine, and $65 per head for all other and owners of brucellosis-exposed cat- breeding swine, except that in the case tle and brucellosis-exposed bison that of whole herd depopulation, indemnity meet the conditions of § 51.3 (a)(1)(iii) payments shall be paid on all swine in may choose either of the two methods the herd at fair market value, as determined by the Administrator, based on a permit (VS Form 1–27) consigning the ani- an appraisal conducted by an inde- mal from a farm or livestock market di- pendent appraiser assigned by the Ad- rectly to a recognized slaughtering establishment; or (f) in unique situations where the ministrator. In cases where indemnity documents listed above are not available, is paid for whole herd depopulation, in- other similarly reliable forms of proof of de- demnity payments, plus any salvage, struction. must not exceed the appraised value of

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each animal. Indemnity payment shall State veterinarian’s office by such per- be made only for brucellosis exposed son who completes the test record. swine or for swine from a herd known (Approved by the Office of Management and to be affected and only when the Ad- Budget under control number 0579–0047) ministrator determines that the destruction of all swine in the herd will [42 FR 64336, Dec. 23, 1977, as amended at 48 FR 57472, Dec. 30, 1983; 54 FR 32435, Aug. 8, contribute to the Brucellosis Eradi- 1989; 56 FR 18506, Apr. 23, 1991] cation Program. Prior to payment of indemnity, proof of destruction 4 shall § 51.5 Identification of animals to be be furnished to the Veterinarian in destroyed because of brucellosis. Charge. (a) The claimant shall be responsible (3) Exposed swine. The Administrator for insuring that any animal for which may authorize 3 the payment of Federal indemnity is claimed shall be identi- indemnity by the United States De- fied in accordance with the provisions partment of Agriculture to an owner of this section within 15 days after hav- whose breeding swine are destroyed being been classified as a reactor or for cause of brucellosis. The indemnity any other animal subject to this part shall not exceed $150 per head for reg- within 15 days after having been con- istered, inbred, or hybrid swine, or $65 demned. The veterinarian in charge per head for all other breeding swine. may extend the time limit to 30 days Indemnity payment shall be made only when a request for such extension is refor such brucellosis exposed swine and ceived by him prior to the expiration only when the Administrator deter- date of the original 15 day period al- mines that the destruction of such lowed, and when he determines that swine will contribute to the Brucellosis the extension will not adversely affect Eradication Program. Prior to pay- the brucellosis eradication program; and except further, that the Adminis- ment of indemnity, proof of destruc- trator shall upon request in specific tion 4 shall be furnished to the Veteri- cases, extend the time limit beyond the narian in Charge. 30-day period when unusual or unfore- (Approved by the Office of Management and seen circumstances occur which pre- Budget under control number 0579–0047) vent or hinder the identification of the animals within the 30-day period, such [42 FR 64336, Dec. 23, 1977] as, but not limited to, floods, storms, EDITORIAL NOTE: For FEDERAL REGISTER ci- or other Acts of God which are beyond tations affecting § 51.3, see the List of CFR the control of the owner, or when iden- Sections Affected, which appears in the tification is delayed due to require- Finding Aids section of the printed volume ments of another Federal Agency. and at www.fdsys.gov. (b) Except as provided in paragraph (b)(4) of this section, cattle and bison § 51.4 Record of tests. to be destroyed because of brucellosis The claimant shall be responsible for shall be individually identified prior to providing information to an APHIS moving interstate by attaching to the representative, State representative, or left ear a metal tag bearing a serial accredited veterinarian so that a com- number and the inscription ‘‘U.S. Reac- plete test record may be made by such tor,’’ or a similar State reactor tag, person on an APHIS approved form for and must be: each herd known to be affected, includ- (1) ‘‘B’’ branded (as defined in § 78.1); ing the reactor tag number of each bru- or cellosis reactor animal and the reg- (2) Accompanied directly to slaugh- istration name and number of each ter by an APHIS or State representa- brucellosis reactor registered animal. tive; or A copy of the applicable test record (3) Moved in vehicles closed with offi- shall be given to the owner of any such cial seals applied and removed by an herd, and one copy of each such record APHIS representative, State represent- shall be furnished to the appropriate ative, accredited veterinarian, or an individual authorized for this purpose by an APHIS representative. The official

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seal numbers must be recorded on the permit to a slaughtering establishment accompanying permit. where State or Federal Meat inspection (4) Reactor and exposed cattle and is available, or to a market approved bison in herds scheduled for herd de- by the State Animal Health Official, or population may be moved interstate to a market approved by the Adminis- without eartagging or branding if they trator, for sale to such slaughtering es- are identified by USDA approved tablishment; 5 except that in the case backtags and either accompanied di- of indemnity for whole herd depopula- rectly to slaughter by an APHIS or tion, as provided for in § 51.3, swine State representative or moved directly shall be destroyed, if possible, on the to slaughter in vehicles closed with of- premises where the animals are held or ficial seals. Such official seals must be penned at the time the indemnity is applied and removed by an APHIS rep- approved, or may be moved for destruc- resentative, State representative, action to another location when move- credited veterinarian, or an individual ment to the location is approved in ad- authorized for this purpose by an vance by an APHIS representative. In APHIS representative. cases where the swine are destroyed (c) Swine shall be individually identi- other than at a slaughtering establish- fied by tagging with a metal tag bear- ment, the carcasses of the swine shall ing a serial number and inscription be disposed of by burial, incineration, ‘‘U.S. Reactor’’ or a similar State reac- or other disposal means authorized by tor tag or other identification approved applicable State law. The destruction by the Administrator, upon request in and disposition of animals destroyed in specific cases, attached to the left ear of each animal. accordance with this section other than at a slaughtering establishment (Approved by the Office of Management and shall be performed in the presence of Budget under control number 0579–0047) an APHIS representative. [42 FR 64336, Dec. 23, 1977, as amended at 47 (d) Time limit for destruction of ani- FR 53324, Nov. 26, 1982; 48 FR 57472, Dec. 30, mals. Payment of indemnity shall be 1983; 50 FR 11993, Mar. 27, 1985; 54 FR 32435, made under this part only if the ani- Aug. 8, 1989; 56 FR 18506, Apr. 23, 1991; 60 FR mals are destroyed within 15 days after 48367, Sept. 19, 1995] the date of identification, pursuant to § 51.6 Destruction of animals; time § 51.5 of the regulations in this part, ex- limit for destruction of animals. cept that the appropriate Veterinarian (a) Cattle. The claimant shall be rein Charge may extend the time limit to sponsible for ensuring that cattle sub- 30 days when request for such exten- ject to this part shall be sold under sion is received from the owner prior to permit to a recognized slaughtering es- the expiration date of the original 15– tablishment or to a specifically ap- day period allowed, or when the ani- proved stockyard for sale to a recog- mals were sold for slaughter prior to nized slaughtering establishment. the expiration date of the original 15– (b) Bison. The claimant shall be re- day period, and when the Veterinarian sponsible for insuring that bison sub- in Charge determines that such exten- ject to this part shall be sold under sion will not adversely affect the Bru- permit to a State or Federal slaugh- cellosis Eradication Program; and ex- tering establishment approved by the cept further, that the Administrator Administrator for this purpose or to a shall, upon request in specific cases, stockyard approved by the Adminis- extend the time limit beyond the 30- trator for sale to such a slaughtering day period when unusual and unfore- establishment, Provided, However, That seen circumstances occur which pre- the Administrator may approve such vent or hinder the destruction of the other bison slaughtering establish- animals within the 30-day period, such ments as may be deemed necessary to as, but not limited to, floods, storms, accomplish destruction of bison subject or other Acts of God which are beyond to this part. (c) Swine. The claimant shall be re- 5 Markets are approved by the Adminis- sponsible for insuring that swine sub- trator in accordance with § 76.18 of this chap- ject to this part shall be sold under ter.

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the control of the owner, or when de- istration papers are unavailable or if struction is delayed due to require- the cattle are less than 1 year old and ments of another Federal Agency. are not registered at the time the claim for indemnity is submitted, the (Approved by the Office of Management and Budget under control number 0579–0047) Veterinarian in Charge may grant a 60- day extension or the Administrator [42 FR 64336, Dec. 23, 1977, as amended at 45 may grant an extension longer than 60 FR 43680, June 27, 1980; 45 FR 86410, Dec. 31, days for the presentation of registra- 1980; 46 FR 5861, Jan. 21, 1981; 47 FR 53324, Nov. 26, 1982; 48 FR 57472, Dec. 30, 1983; 50 FR tion papers. 11993, Mar. 27, 1985; 51 FR 11300, Apr. 2, 1986; (Approved by the Office of Management and 51 FR 32599, Sept. 12, 1986; 54 FR 32435, Aug. Budget under control number 0579–0047) 8, 1989; 56 FR 18506, Apr. 23, 1991; 59 FR 12533, Mar. 17, 1994] [42 FR 64336, Dec. 23, 1977. Redesignated at 46 FR 13674, Feb. 23, 1981, and 47 FR 53324, Nov. § 51.7 Claims for indemnity. 26, 1982, and amended at 47 FR 53324, Nov. 26, 1982; 48 FR 57472, Dec. 30, 1983; 50 FR 11993, (a) Claims for indemnity for animals Mar. 27, 1985; 54 FR 32435, Aug. 8, 1989; 56 FR destroyed because of brucellosis shall 18506, Apr. 23, 1991] be presented on indemnity claim forms furnished by APHIS on which the § 51.8 Disinfection of premises, convey- owner of the animals covered thereby ances, and materials. shall certify that the animals are or All premises, including all struc- are not subject to any mortgage as de- tures, holding facilities, conveyances, fined in this part. If the owner states and materials, contaminated because there is a mortgage, the APHIS indem- of occupation or use by brucellosis re- nity claim form shall be signed by the actor or exposed animals shall be prop- owner and by each person holding a erly cleaned and disinfected with a dis- mortgage on the animals, consenting infectant permitted by APHIS in ac- to the payment of any indemnity al- cordance with recommendations of the lowed to the person specified thereon. APHIS or State representative within Payment will be made only if the 15 days from the date reactors were re- claimant has submitted a complete in- moved from the premises, except that demnity claim form to, and such claim the appropriate Veterinarian in Charge has been approved by the Veterinarian may extend the time limit for disinfec- in Charge or by an APHIS representation to 30 days when request for such tive designated by him. On claims for extension is received by him prior to indemnity made under the provisions the expiration date of the original 15- of § 51.3, the Veterinarian in Charge or day period allowed, and when he deter- an APHIS representative designated by mines that such extension will not ad- him shall record on the APHIS indem- versely affect the Brucellosis Eradi- nity claim form the amount of Federal cation Program; and except further, and State indemnity payments that ap- that the Administrator may, upon re- pear to be due to the owner of the ani- quest in specific cases, extend the time mals. The owner of the animals shall limit beyond the 30-day period when be furnished a copy of the completed unusual and unforeseen circumstances APHIS indemnity claim form. The Vet- occur, such as but not limited to erinarian in Charge or an APHIS rep- floods, storms, or other Acts of God, resentative designated by him shall which are beyond the control of the then forward the completed APHIS in- owner, preventing or hindering the dis- demnity claim form to the Adminis- infection of premises, conveyances, and trator for further action on the claim. materials. Certain premises may be ex- No charges for holding the animals on empted from such cleaning and dis- the farm pending slaughter or for infecting requirements by approval of trucking by the owner shall be so de- the appropriate Veterinarian in Charge ducted or otherwise paid by the United on written recommendations by the States Department of Agriculture. APHIS or State representative or when (b) Claims for indemnity for reg- a written report by the APHIS or State istered cattle shall be accompanied by representative determines that there the cattle’s registration papers issued are no buildings, holding facilities, in the name of the owner. If the reg- conveyances, or other materials on the

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premises that would require such ter; shipped for slaugher, or delivered cleaning and disinfection. for slaughter. (h) If any known brucellosis reactor (Approved by the Office of Management and animal remains in the herd, unless, in Budget under control number 0579–0047) the opinion of the Veterinarian in [42 FR 64336, Dec. 23, 1977. Redesignated at 46 Charge, a reasonable search has been FR 13674, Feb. 23, 1981, and 47 FR 53324, Nov. made for the brucellosis reactor animal 26, 1982; 48 FR 57472, Dec. 30, 1983; 50 FR 11993, and the brucellosis reactor animal Mar. 27, 1985; 54 FR 32435, Aug. 8, 1989; 56 FR could not be found and removed. 18506, Apr. 23, 1991] (i) If the animals are brucellosis reac- § 51.9 Claims not allowed. tor animals which are slaughtered other than as part of a herd depopula- Claims for compensation for animals tion, and which are from a herd: (1) destroyed because of brucellosis shall That was already classified as a ‘‘herd not be allowed if any of the following known to be affected’’ at the time the circumstances exist: animals were identified as brucellosis (a) If the claimant has failed to com- reactor animals and (2) for which an ply with any of the requirements of approved action plan or approved indi- this part. vidual herd plan (as defined in § 78.1 of (b) If the existence of brucellosis in this chapter) was not in effect at the the animal was determined based on time the claim was filed. the results of an official test, as de- (Approved by the Office of Management and fined in § 78.1 of this chapter, and spe- Budget under control number 0579–0047) cific instructions for the administration of the official test had not pre- [42 FR 64336, Dec. 23, 1977. Redesignated at 46 viously been issued to the individual FR 13674, Feb. 23, 1981, and 47 FR 53324, Nov. 26, 1982, and amended at 47 FR 53324, Nov. 26, performing the test by APHIS and the 1982; 48 FR 57472, Dec. 30, 1983; 50 FR 11993, State animal health official. Mar. 27, 1985; 50 FR 47036, Nov. 14, 1985; 51 FR (c) If all cattle, bison, and swine eli- 11300, Apr. 2, 1986; 54 FR 32435, Aug. 8, 1989; 56 gible for testing in the claimant’s herd FR 18506, Apr. 23, 1991; 63 FR 47423, Sept. 8, have not been tested for brucellosis 1998] under APHIS or State supervision. § 51.10 Part 53 of this chapter not ap- (d) If the animals are: plicable. (1) Barrows or gilts maintained for feeding purposes; or No claim for indemnity for animals (2) Spayed heifers or steers, unless destroyed because of brucellosis shall the steers are work oxen, or unless the hereafter be paid under the regulations contained in part 53 of this chapter, spayed heifers or steers are unweaned but all such claims shall be presented animals in a herd approved for depopu- and paid pursuant to and in compliance lation in accordance with § 51.3 of this with regulations contained in this part. part. (e) If the animals are classified as re- [42 FR 64336, Dec. 23, 1977. Redesignated at 46 actors and are unofficial vaccinates, FR 13674, Feb. 23, 1981, and 47 FR 53324, Nov. unless there is either a record of a neg- 26, 1982; 50 FR 11993, Mar. 27, 1985] ative official test made not less than 30 days following the date of unofficial Subpart B—Indemnity for Sheep, vaccination or unless other APHIS ap- Goats, and Horses proved tests show the unofficial vaccinates are affected with virulent SOURCE: 69 FR 41912, July 13, 2004, unless Brucella. otherwise noted. (f) If there is substantial evidence that the owner or his agent has in any § 51.20 Definitions. way been responsible for any unlawful Accredited veterinarian. A veteri- or improper attempt to obtain indem- narian approved by the Administrator nity funds for such animal. in accordance with the provisions of (g) If, at the time of test or con- part 161 of this title to perform func- demnation, the animals belonged to or tions specified in parts 1, 2, 3, and 11 of were upon the premises of any person subchapter A, and subchapters B, C, to whom they had been sold for slaugh- and D of this chapter, and to perform

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functions required by cooperative results for brucellosis in accordance State-Federal disease control and with one of the following tests: eradication programs. Administrator. The Administrator, Test Positive results Animal and Plant Health Inspection Standard plate test (SPT) ...... If antibody titer positive at Service, or any person authorized to 1:100 dilution or higher. act for the Administrator. Standard tube test (STT) ...... If antibody titer positive at Affected herd/flock. Any herd or flock 1:100 dilution or higher. Rivanol test ...... If antibody titer positive at in which any cattle, bison, breeding 1:50 dilution or higher. swine, sheep, or goat has been classi- Particle concentration fluores- If reading is 0.3 or lower. fied as a brucellosis reactor and which cence immunoassay has not been released from quarantine. (PCFIA). Complement fixation test (CF) If reading is 2+:20 dilution. Animal. Sheep, goats, and horses. Animal and Plant Health Inspection (3) Any cattle, bison, or swine classi- Service (APHIS). The Animal and Plant fied as a brucellosis reactor as provided Health Inspection Service of the United in the definition of official test in § 78.1 States Department of Agriculture. of this chapter. APHIS representative. An individual Condemn. The determination made by employed by APHIS who is authorized an APHIS representative, State rep- to perform the function involved. resentative, or accredited veterinarian Appraisal. An estimate of the fair that animals for which indemnity is market value of an animal to be de- sought under this subpart will be destroyed because of brucellosis. stroyed. Brucellosis exposed. Except for brucel- Designated brucellosis epidemiologist. losis reactors, animals that are part of An epidemiologist selected by the a herd known to be affected, or are in State animal health official and the a quarantined feedlot or a quarantined Veterinarian in Charge to perform the pasture, or are brucellosis suspects, or functions required. The regional epi- that have been in contact with a bru- demiologist and the APHIS brucellosis cellosis reactor for a period of 24 hours staff must concur in the selection and or more, or for a period of less than 24 appointment of the designated epi- hours if the brucellosis reactor has demiologist. aborted, calved, or farrowed within the past 30 days or has a vaginal or uterine Destroyed. Condemned under State discharge. authority and slaughtered or otherwise dies. Brucellosis reactor animal. (1) Any sheep or goat that has been determined Flock. Any group of sheep maintained by a designated brucellosis epidemiolo- on common ground for any purpose, or gist 1 to be affected with brucellosis, two or more groups of sheep under based on test results, herd/flock his- common ownership or supervision, geo- tory, and/or culture results. Any test graphically separated but which have used for cattle and bison under the an interchange or movement of ani- APHIS official brucellosis eradication mals without regard to health status. program (see part 78 of this chapter) Herd. Any group of goats, or mixed may be used, but test results must be sheep and goats, maintained on com- interpreted by a designated brucellosis mon ground for any purpose, or two or epidemiologist. more groups of goats, or two or more (2) Any horse that has been deter- groups of mixed sheep and goats, under mined by a designated brucellosis epi- common ownership or supervision, geo- demiologist to be affected with brucel- graphically separated but which have losis, based on epidemiological infor- an interchange or movement of ani- mation or culture results, or positive mals without regard to health status. Herd/flock depopulation. Removal by slaughter or other means of destruc- 1 Requirements for designated brucellosis tion of all sheep or goats in a flock or epidemiologists are contained in Veterinary Services Memorandum No. 551.10. A copy of herd, or from a specific premises or this memorandum may be obtained from an under common ownership prior to re- APHIS representative, the State animal stocking such premises with new ani- health official, or a State representative. mals.

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Mortgage. Any mortgage, lien, or in- concerned, or any person authorized to terest that is recorded under State law act for the Veterinarian in Charge. or identified in the indemnity claim form filed in accordance with this sub- § 51.21 Cooperation with States. part, and held by any person other than The Administrator has been dele- the one claiming indemnity. gated the authority to cooperate with Official seal. A serially numbered the proper State authorities in the metal strip consisting of a self-locking eradication of brucellosis and to pay device on one end and a slot on the indemnities for the destruction of bru- other end, which forms a loop when the cellosis-reactor animals or brucellosis- ends are engaged and which cannot be exposed animals. reused if opened, and is applied by a representative of the Veterinarian in § 51.22 Payment to owners for goats, sheep, and horses destroyed. Charge or the State animal health official. (a) The Administrator may authorize Owner. Any person who has legal or the payment of Federal indemnity by rightful title to sheep, goats, and the U.S. Department of Agriculture to horses, whether or not the animals are any owner whose goats, sheep, or horses are destroyed after having been subject to a mortgage. approved for destruction by APHIS. 1 Permit. An official document for Goats or sheep must be destroyed as movement of animals under this subpart of a whole herd/flock depopulation part issued by an APHIS representa- to be eligible for Federal indemnity. tive, State representative, or accred- (b) The amount of Federal indemnity ited veterinarian listing the disease will be determined in accordance with status and identification of the animal, the regulations in this part that were where consigned, cleaning and dis- in effect on the date infected animals infecting requirements, and proof of were found, or the date that the whole- slaughter certification. herd/flock depopulation or destruction Person. Any individual, corporation, of individual animals was approved. company, association, firm, partner- (c) Prior to payment of indemnity, ship, society, or joint stock company, proof of destruction must be furnished or other legal entity. to the Veterinarian in Charge. Registered sheep and goats. Sheep and goats for which individual records of § 51.23 Eligibility for indemnity. ancestry are recorded and maintained Owners of animals destroyed because by a breed association whose purpose is of brucellosis are eligible to receive the improvement of the species, and for Federal indemnity for their animals if which individual registration certifi- the animals are: cates are issued and recorded by such (a) Sheep and goats in an affected breed association. herd or flock; State. Any State, the District of Co- (b) Sheep and goats that were ob- lumbia, Puerto Rico, the Virgin Islands tained from a herd or flock that was of the United States, Guam, the North- subsequently found to be an affected ern Mariana Islands, or any other terri- herd or flock. Epidemiological informa- tory or possession of the United States. tion such as test results, herd/flock his- State representative. An individual em- tory, and related evidence will be used ployed in animal health activities by a to establish a probable date when the State or a political subdivision thereof, herd or flock was first affected with and who is authorized by such State or political subdivision to perform the 1 The Administrator will authorize pay- function involved under a cooperative ment of Federal indemnity by the U.S. De- agreement with the United States De- partment of Agriculture as provided in partment of Agriculture. § 51.24: (a) As long as sufficient funds appro- Veterinarian in Charge. The APHIS priated by Congress appear to be available for this purpose for the remainder of the fis- veterinary official who is assigned by cal year; (b) in States or areas not under the Administrator to supervise and Federal quarantine; (c) in States requesting perform the official animal health payment of Federal indemnity; and (d) in work of APHIS in the State or area States not requesting a lower rate.

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brucellosis. Animals removed from the each animal. It must also include the herd or flock after that date will be individual identification of each tested considered exposed to the disease and animal. Any unique, individually num- eligible for indemnity; those removed bered identification is acceptable. The before that date will not; animal’s owner and the appropriate (c) Individual horses that have been State veterinarian’s office will each re- found to be brucellosis reactor animals. ceive a copy of the test record. § 51.24 Maximum per-head indemnity (Approved by the Office of Management and amounts. Budget under control number 0579–0185) Owners of the types of animals listed in § 51.22 of this subpart are eligible to § 51.27 Identification of goats, sheep, receive Federal indemnity for their and horses to be destroyed. animals. All animals must be individ- The claimant must ensure that any ually appraised to determine their fair goats, sheep, and horses for which in- market value. The indemnity amount demnity is claimed are marked with will be the appraised value minus the unique, individually numbered identi- salvage value of the animal, up to a fication showing they are to be de- maximum of $20,000 per animal in the stroyed. This must be done within 15 case of horses. An independent ap- days after the animals are condemned. praiser selected by the Administrator The Veterinarian in Charge may ex- will conduct appraisals. APHIS will pay the cost of appraisals. tend the time limit to 30 days when the Veterinarian in Charge receives a re- § 51.25 Proof of destruction. quest for extension prior to the expira- The Veterinarian in Charge will action date of the original 15-day period, cept any of the following documents as and when the Veterinarian in Charge proof of destruction: determines that the extension will not (a) A postmortem report; adversely affect the brucellosis eradi- (b) A meat inspection certification of cation program. However, the Adminis- slaughter; trator may extend the time limit be- (c) A written statement by a State yond 30 days when unusual or unfore- representative, APHIS representative, seen circumstances occur that prevent or accredited veterinarian attesting to or hinder the identification of the ani- the destruction of the animals; mal within 30 days, such as, but not (d) A written, sworn statement by limited to, floods, storms, or other the owner or caretaker of the animal Acts of God, which are beyond the con- attesting to the destruction of the ani- trol of the owner, or when identifica- mals; tion is delayed due to requirements of (e) A permit (VS Form 1–27) con- another Federal agency. signing the animal from a farm or livestock market directly to a slaughter (Approved by the Office of Management and establishment; or Budget under control number 0579–0185) (f) In unique situations where none of the documents listed above are avail- § 51.28 Moving goats, sheep, and able, other similarly reliable forms of horses to be destroyed. proof of destruction. Goats, sheep, and horses to be de- (Approved by the Office of Management and stroyed because of brucellosis must be Budget under control number 0579–0185) accompanied by a permit and either: (a) Accompanied directly to slaugh- § 51.26 Record of tests. ter by an APHIS or State representa- An APHIS representative, State rep- tive; or resentative, or accredited veterinarian (b) Moved in vehicles closed with offi- will compile, on an APHIS-approved cial seals applied and removed by an form, a complete test record for each APHIS representative, State represent- animal. The claimant must provide any ative, accredited veterinarian, or an in- information necessary to complete the dividual authorized for this purpose by form. The test record must include the an APHIS representative. The official type of test and the test results for

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seal numbers must be recorded on the APHIS. On the form, the owner of the accompanying permit. animals must certify whether the animals are subject to a mortgage. If the (Approved by the Office of Management and Budget under control number 0579–0185) owner states there is a mortgage, the claim form must be signed by the § 51.29 Destruction of animals; time owner and by each mortgage holder, limit. consenting to the payment of any in- (a) The claimant must ensure that demnity allowed to the owner. Pay- goats, sheep, and horses infected with ment will be made only if the claimant or exposed to B. abortus are either: has submitted a complete indemnity (1) Sold under permit to a recognized claim form to the Veterinarian in slaughtering establishment; Charge and the claim has been ap- (2) Moved to an approved stockyard proved by the Veterinarian in Charge for sale to a recognized slaughtering or by an APHIS representative des- establishment; or ignated by him or her. The Veteri- (3) Destroyed and buried, incinerated, narian in Charge or an APHIS rep- or rendered in accordance with applica- resentative designated by the Veteri- ble State law. narian in Charge will record on the (b) The claimant must ensure that APHIS indemnity claim form the goats and sheep destroyed because of B. amount of Federal and State indem- melitensis are destroyed and buried, in- nity payments that appear to be due to cinerated, or rendered in accordance the owner of the animals. The owner of with applicable State law. the animals will receive a copy of the (c) Indemnity will be paid under this completed APHIS indemnity claim part only if the animals are destroyed form. The owner is responsible for pay- within 15 days after the date they are ing all fees for holding the animals on marked with identification showing the farm pending disposal and for all they are to be destroyed. However, the trucking fees. Veterinarian in Charge may extend the (b) Claims for indemnity for reg- time limit to 30 days if: istered sheep and registered goats must (1) The animals’ owner asks the Vet- be accompanied by the animal’s reg- erinarian in Charge for an extension istration papers, issued in the name of before the initial 15-day period expires, the owner. If the registration papers or the animals were sold for slaughter are unavailable or if the animal is less before the original 15-day period ex- than 1 year old and not registered at pires; and the time the claim for indemnity is (2) The Veterinarian in Charge deter- submitted, the Veterinarian in Charge mines that extending the time limit may grant a 60-day extension or the will not adversely affect the Brucel- Administrator may grant an extension losis Eradication Program. longer than 60 days for the presen- (d) The Administrator may extend tation of registration papers. Any ani- the time limit beyond 30 days when un- mal that is not registered but is eligi- usual and unforeseen circumstances ble for registration at the time the occur that prevent or hinder the de- claim is submitted will be considered struction of the animals within 30 unregistered unless the animal has days, such as, but not limited to, been in the flock for less than 12 floods, storms, or other Acts of God, months. which are beyond the control of the (Approved by the Office of Management and owner, or when destruction is delayed Budget under control number 0579–0185) due to requirements of another Federal agency. § 51.31 Disinfecting premises, convey- (Approved by the Office of Management and ances, and materials. Budget under control number 0579–0185) All premises, including all structures, holding facilities, conveyances, § 51.30 Claims for indemnity. and materials contaminated because (a) Claims for indemnity for goats, they have been used by animals de- sheep, and horses destroyed because of stroyed because of brucellosis, must be brucellosis must be made using an in- properly cleaned and disinfected in ac- demnity claim form furnished by cordance with recommendations of the

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APHIS or State representative. Clean- § 51.33 Multiple indemnity payments. ing and disinfecting must be completed APHIS has indemnity programs for within 15 days from the date the ani- several other livestock diseases. How- mals were removed from the premises, ever, if a claim is paid for indemnity except that the Veterinarian in Charge for animals destroyed because of bru- may extend the time limit for disinfec- cellosis, no other claims for indemnity tion to 30 days when he or she receives will be paid for the same animals. a request prior the expiration date of the original 15 days, and when the Vet- PART 52—SWINE DESTROYED erinarian in Charge determines that an BECAUSE OF PSEUDORABIES extension will not adversely affect the Brucellosis Eradication Program. The Sec. Administrator may extend the time 52.1 Definitions. limit beyond 30 days when unusual and 52.2 Payment of indemnity. unforeseen circumstances occur that 52.3 Appraisal of swine. 52.4 Presentation of claims. prevent or hinder disinfection of the 52.5 Report of net salvage proceeds. premises, conveyances, and materials 52.6 Claims not allowed. within 30 days, such as, but not limited 52.7 Disinfection of premises, conveyances, to floods, storms, or other Acts of God, and materials. which are beyond the control of the AUTHORITY: 7 U.S.C. 8301–8317; 7 CFR 2.22, owner. A premises may be exempted 2.80, and 371.4. from such cleaning and disinfecting re- SOURCE: 64 FR 2549, Jan. 15, 1999, unless quirements if the APHIS or State rep- otherwise noted. resentative recommends it in writing and the Veterinarian in Charge ap- § 52.1 Definitions. proves. Accredited veterinarian. A veterinarian approved by the Administrator (Approved by the Office of Management and in accordance with the provisions of Budget under control number 0579–0185) part 161 of this chapter to perform § 51.32 Claims not allowed. functions specified in subchapters B, C, and D of this chapter. Claims for indemnity for goats, Administrator. The Administrator, sheep, and horses destroyed because of Animal and Plant Health Inspection brucellosis will not be allowed if any of Service, or any other employee of the the following circumstances exist: Animal and Plant Health Inspection (a) The claimant has failed to comply Service, United States Department of with any of the requirements of this Agriculture, delegated to act in the Ad- part; ministrator’s stead. (b) The claim is based on a brucel- Animal and Plant Health Inspection losis test, and the person who adminis- Service (APHIS). The Animal and Plant tered the test was not properly trained, Health Inspection Service of the United authorized, or certified at the time of States Department of Agriculture. the test; APHIS employee. Any individual em- (c) Testing of goats, sheep, and ployed by the Animal and Plant Health Inspection Service who is authorized horses in the herd or flock for brucel- by the Administrator to do any work losis was not done under APHIS or or perform any duty in connection with State supervision, or by an accredited the control and eradication of disease. veterinarian; Approved differential pseudorabies test. (d) There is substantial evidence that Any test for the diagnosis of the claim is an unlawful or improper pseudorabies that can distinguish vac- attempt to obtain indemnity; or cinated swine from infected swine; is (e) If, at the time of test or con- produced under license from the Sec- demnation, the animals belonged to or retary of Agriculture under the Virus- were upon the premises of any person Serum-Toxin Act of March 4, 1913, and to whom they had been sold for slaugh- subsequent amendments (21 U.S.C. 151 ter, shipped for slaughter, or delivered et seq.) with indications for use in the for slaughter. Cooperative State-Federal

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Pseudorabies Eradication Program; or based on a diagnosis by an official and is conducted in a laboratory ap- pseudorabies epidemiologist. proved by the Administrator. 1 Materials. Parts of barns or other Department. The United States De- structures, straw, hay, and other feed partment of Agriculture. for animals, farm products or equip- Herd. Any group of swine maintained ment, clothing, and articles stored in on common ground for any purpose, or or adjacent to barns or other struc- two or more groups of swine under tures. common ownership or supervision that Mortgage. Any mortgage, lien, or are geographically separated but that other security or beneficial interest are determined by an official held by any person other than the one pseudorabies epidemiologist to have an claiming indemnity. interchange or movement of animals Net salvage. The amount received for that could cause the transmission of swine destroyed because of pseudorabies from one group to an- pseudorabies, after deducting freight, other. trucking, yardage, commission, slaughtering charges, and similar costs to the Inspector in charge. An APHIS em- owner. ployee who is designated by the Admin- Official pseudorabies epidemiologist. A istrator to take charge of work in con- State or Federally employed veteri- nection with the control and eradi- narian designated by the State animal cation of disease. health official and the veterinarian in Known infected breeding sow. Any charge to investigate and diagnose breeding sow that has been determined pseudorabies in livestock. to be infected with pseudorabies based Official pseudorabies test. Any test for on an official pseudorabies test or an the diagnosis of pseudorabies approved approved differential pseudorabies test, by the Administrator and conducted in or as diagnosed by an official a laboratory approved by the Adminis- pseudorabies epidemiologist as having trator. The following tests for the diag- pseudorabies. nosis of pseudorabies have been ap- Known infected herd. Any herd in proved by the Administrator: Micro- which swine have been determined to titration Serum-Virus Neutralization be infected with pseudorabies based on Test; Virus Isolation and Identification an official pseudorabies test or an ap- Test; Fluorescent Antibody Tissue Sec- proved differential pseudorabies test, tion Test; Enzyme-Linked Immunosorbent Assay (ELISA) Test, 1 The names and addresses of laboratories except for approved differential approved by the Administrator to conduct pseudorabies tests other than the approved differential pseudorabies tests are glycoprotein I (gpI) ELISA test; Latex published in the Notices Section of the FED- Agglutination Test (LAT); and Particle ERAL REGISTER. A list of approved labora- Concentration Fluorescence tories is also available upon request from the Immunoassay (PCFIA) Test. 2 State, Animal and Plant Health Inspection Service, 4700 River Road Unit 37, Riverdale, Maryland Federal, and university laboratories 20737–1231. State, Federal, and university lab- will be approved by the Administrator oratories will be approved by the Adminis- following his determination that the trator when he or she determines that the laboratory: has personnel trained at laboratory: employs personnel trained at the the Veterinary Services Diagnostic National Veterinary Services Laboratories Laboratory at Ames, Iowa, assigned to assigned to supervise the testing; follows supervise the test; follows standard standard test protocols; meets check test test protocol; meets check test pro- proficiency requirements; and will report all test results to State and Federal animal ficiency requirements; and will report health officials. Before the Administrator may withdraw approval of any laboratory for 2 Copies of the test protocols (Rec- failure to meet any of these conditions, the ommended Minimum Standards for Diag- Administrator must give written notice of nostic Tests Employed in the Diagnosis of the proposed withdrawal to the director of Pseudorabies (Aujeszky’s Disease) are avail- the laboratory, and must give the director able upon request from the Animal and Plant an opportunity to respond. If there are con- Health Inspection Service, Veterinary Serv- flicts as to any material fact, a hearing will ices, Operational Support, 4700 River Road be held to resolve the conflict. Unit 33, Riverdale, MD 20737–1231.

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all test results to State and Federal State representative. A person regu- animal health officials. 3 larly employed in the animal health Official seal. A serially numbered work of a State and who is authorized metal or plastic strip, consisting of a by that State to perform the function self-locking device on one end and a involved under a cooperative agree- slot on the other end, that forms a loop ment with the United States Depart- when the ends are engaged and that ment of Agriculture. cannot be reused if opened, or a seri- Veterinarian in charge. The veterinary ally numbered, self-locking button that official of Veterinary Services, APHIS, can be used for this purpose. who is assigned by the Administrator Permit. An official document for to supervise and perform official ani- movement of swine under this part mal health work for APHIS in the that is issued by an APHIS employee, State concerned. State representative, or accredited veterinarian and that lists the disease sta- [64 FR 2549, Jan. 15, 1999, as amended at 65 tus and individual identification of the FR 20711, Apr. 18, 2000; 68 FR 6342, Feb. 7, 2003] animal, where consigned, cleaning and disinfection requirements, and proof of § 52.2 Payment of indemnity. slaughter certification by a recognized slaughtering establishment. (a) Except as provided in paragraph Person. Any individual, corporation, (b) of this section, the Administrator is company, association, firm, partner- authorized to agree on the part of the ship, society, joint stock company, or Department to pay indemnity to the other legal entity. owner of herds of swine destroyed be- Pseudorabies. The contagious, infec- cause the herds are known to be in- tious, and communicable disease of fected with pseudorabies, or individual livestock and other animals, also breeding sows destroyed because they known as Aujeszky’s disease, mad itch, are known to be infected with or infectious bulbar paralysis. pseudorabies. The amount of indemnity Recognized slaughtering establishment. paid, together with the amount for net A slaughtering establishment oper- salvage the owner receives when the ating under the Federal Meat Inspec- animals are slaughtered, shall not ex- tion Act (21 U.S.C. 601 et seq.) or a State ceed the fair market value of the meat inspection act. 4 swine. Such swine must be sent di- Secretary. The Secretary of Agri- rectly to slaughter under permit in a culture of the United States, or any of- conveyance closed with an official seal ficer or employee of the Department applied and removed by either an delegated to act in the Secretary’s APHIS employee, a State representa- stead. tive, an accredited veterinarian, or an State. Each of the States of the individual authorized for this purpose United States, the District of Colum- by an APHIS employee. The swine bia, Puerto Rico, the Northern Mariana must be sent to a recognized slaugh- Islands, Guam, the Virgin Islands of tering establishment. the United States, or any other terri- (b) If swine from herds that are de- tory or possession of the United States. stroyed because the herds are known to be infected with pseudorabies are not 3 Before the Administrator withdraws the accepted at a recognized slaughtering approval of any laboratory, the Director of establishment, or the owner and an the laboratory will be given a notice by the APHIS employee or State representa- Administrator of the proposed disapproval tive agree they will not be accepted by and the reasons for it, and the Director will a recognized slaughtering establish- have the opportunity to respond. In those in- ment, the Administrator is authorized stances where there are conflicts as to the to pay 100 percent of the expenses of facts, a hearing will be held to resolve such conflicts. the purchase, destruction, and disposi- 4 A list of recognized slaughtering estab- tion of such swine. lishments is available upon request from the (Approved by the Office of Management and Animal and Plant Health Inspection Service, Budget under control number 0579–0151) 4700 River Road Unit 37, Riverdale, Maryland 20737–1231. [65 FR 20711, Apr. 18, 2000]

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§ 52.3 Appraisal of swine. § 52.5 Report of net salvage proceeds. (a) Herds of swine and individual A report of the amount for net sal- breeding sows to be destroyed because vage derived from the sale of each ani- they are known to be infected with mal for which a claim for indemnity is pseudorabies will be appraised by an made under § 52.2(a) must be made on a APHIS employee and a representative salvage form that shows the gross re- of the State jointly, a representative of ceipts, expenses if any, and net pro- the State alone, or, if the State au- ceeds. The original or a copy of the sal- thorities approve, by an APHIS em- vage form must be furnished by the ployee alone. owner to the veterinarian in charge. (b) The appraisal of swine will be (Approved by the Office of Management and based on the fair market value as de- Budget under control number 0579–0151) termined by the meat or breeding value [65 FR 20712, Apr. 18, 2000] of the animals. Animals may be appraised in groups, provided that where § 52.6 Claims not allowed. appraisal is by the head, each animal (a) The Department will not allow in the group is the same value per claims arising out of the destruction of head, and where appraisal is by the swine unless the swine have been ap- pound, each animal in the group is the praised as prescribed in this part and same value per pound. the owners have signed a written (c) Appraisals of swine must be re- agreement to the appraisals. ported on forms furnished by APHIS (b) The Department will not allow and signed by the owner of the swine. claims arising out of the destruction of Reports of appraisals must show the swine that have been moved or handled number of swine and the value per head by the owner or a representative of the or the weight and value by pound. owner in violation of a law or regula- (Approved by the Office of Management and tion administered by the Secretary re- Budget under control number 0579–0137) garding animal disease, or in violation of a law or regulation for which the [64 FR 2549, Jan. 15, 1999, as amended at 65 FR 20711, Apr. 18, 2000] Secretary has entered into a cooperative agreement. § 52.4 Presentation of claims. (Approved by the Office of Management and (a) When swine have been destroyed Budget under control number 0579–0137) under § 52.2(a), any claim for indemnity [64 FR 2549, Jan. 15, 1999. Redesignated at 65 must be presented, along with the re- FR 20711, Apr. 18, 2000] port of net salvage proceeds required under § 52.5, to the veterinarian in § 52.7 Disinfection of premises, convey- charge on a form furnished by APHIS. ances, and materials. (b) When swine have been destroyed All premises, including barns, stock- under § 52.2(b), any claim for indemnity yards and pens, and all cars and other must be presented, through the inspec- conveyances, and the materials on any tor in charge, to APHIS on a form fur- premises or conveyances used to house nished by APHIS. or transport swine for which indemnity (c) For all claims for indemnity, the is paid under this part must be cleaned owner of the swine must certify on the and disinfected under the supervision claim form that the swine covered are, of an APHIS employee after removal of or are not, subject to any mortgage as the swine from the known infected defined in this part. If the owner states herd. Premises may be restocked with there is a mortgage, the owner and swine 30 days following an approved each person holding a mortgage on the cleaning and disinfection, unless an of- swine must sign, consenting to the ficial pseudorabies epidemiologist de- payment of indemnity to the person termines that a shorter or longer pe- specified on the form. riod of time is adequate or necessary to protect new animals against infection. (Approved by the Office of Management and The owner to whom the indemnity is Budget under control number 0579–0137) paid will be responsible for expenses in- [65 FR 20711, Apr. 18, 2000] curred in connection with the cleaning

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and disinfection, except for cleaning by the Administrator to do any work and disinfection of the conveyances or perform any duty in connection with used to transport the swine to the loca- the control and eradication of disease. tion of disposal. Bird. Any member of the class aves [64 FR 13065, Mar. 17, 1999. Redesignated at 65 other than poultry. FR 20711, Apr. 18, 2000] Department. The United States De- partment of Agriculture. PART 53—FOOT-AND-MOUTH DIS- Disease. Foot-and-mouth disease, rin- EASE, PLEUROPNEUMONIA, RIN- derpest, contagious pleuropneumonia, exotic Newcastle disease, highly patho- DERPEST, AND CERTAIN OTHER genic avian influenza, infectious salm- COMMUNICABLE DISEASES OF on anemia, spring viremia of carp, or LIVESTOCK OR POULTRY any other communicable disease of livestock or poultry that in the opinion Sec. of the Secretary constitutes an emer- 53.1 Definitions. gency and threatens the livestock or 53.2 Determination of existence of disease; agreements with States. poultry of the United States. 53.3 Appraisal of animals or materials. Exotic Newcastle Disease (END). Any 53.4 Destruction of animals. virulant Newcastle disease. Exotic 53.5 Disinfection or destruction of mate- Newcastle disease is an acute, rapidly rials. spreading, and usually fatal viral dis- 53.6 Disinfection of animals. ease of birds and poultry. 53.7 Disinfection of premises, conveyances, Highly pathogenic avian influenza. (1) and materials. 53.8 Presentation of claims. Any influenza virus that kills at least 53.9 Mortgage against animals or materials. 75 percent of eight 4- to 6-week-old sus- 53.10 Claims not allowed. ceptible chickens within 10 days following intravenous inoculation with 0.2 AUTHORITY: 7 U.S.C. 8301–8317; 7 CFR 2.22, 2.80, and 371.4. ml of a 1:10 dilution of a bacteria-free, infectious allantoic fluid; CROSS REFERENCE: For non-applicability of (2) Any H5 or H7 virus that does not part 53 with respect to certain claims for indemnity, see § 51.10 of this chapter. meet the criteria in paragraph (1) of this definition, but has an amino acid § 53.1 Definitions. sequence at the hemagglutinin cleavage site that is compatible with highly Accredited veterinarian. A veterinarian approved by the Administrator pathogenic avian influenza viruses; or in accordance with part 161 of this (3) Any influenza virus that is not an chapter to perform functions specified H5 or H7 subtype and that kills one to in parts 1, 2, 3, and 11 of subchapter A five chickens and grows in cell culture of this chapter and subchapters B, C, in the absence of trypsin. and D of this chapter, and to perform Inspector in charge. An APHIS em- functions required by cooperative ployee who is designated by the Admin- State-Federal disease control and istrator to take charge of work in con- eradication programs. nection with the control and eradi- Administrator. The Administrator, cation of disease. Animal and Plant Health Inspection ISA Program veterinarian. The APHIS Service, or any person authorized to veterinarian assigned to manage the act for the Administrator. infectious salmon anemia program for Animal and Plant Health Inspection APHIS in the State of Maine and who Service. The Animal and Plant Health reports to the Area Veterinarian in Inspection Service of the United States Charge. Department of Agriculture (APHIS). Materials. Parts of barns or other Animals. Livestock, poultry, and all structures, straw, hay, and other feed other members of the animal kingdom, for animals, farm products or equip- including birds whether domesticated ment, clothing, and articles stored in or wild, but not including man. or adjacent to barns or other struc- APHIS employee. Any individual em- tures. ployed by the Animal and Plant Health Mortgage. Any mortgage, lien, or Inspection Service who is authorized other security or beneficial interest

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held by any person other than the one from any State, the Department may claiming indemnity. pay up to 100 percent of the purchase, Person. Any individual, corporation, destruction, and disposition of animals company, association, firm, partner- and materials required to be destroyed: ship, society, joint stock company, or Provided, further, That the cooperative other legal entity. program for the purchase, destruction, Pet bird. Any bird that is kept for and disposition of birds shall be limited personal pleasure and is not for sale. to birds which are identified in docu- Poultry. Chickens, ducks, geese, mentation pursuant to Cooperative swans, turkeys, pigeons, doves, pheas- Agreements, 1 as constituting a threat ants, grouse, partridges, quail, guinea to the poultry industry of the United fowl, and pea fowl. States: And provided further, That the Secretary. The Secretary of Agri- Secretary may authorize other ar- culture of the United States, or any of- rangements for the payment of such ficer or employee of the Department to expenses upon finding that an extraor- whom authority has been or may be dinary emergency exists. delegated to act in the Secretary’s stead. [37 FR 5689, Mar. 18, 1972, as amended at 49 FR 3448, Jan. 27, 1984; 49 FR 26712, June 29, State. Each of the States of the 1984; 61 FR 56883, Nov. 5, 1996; 67 FR 17610, United States, the District of Colum- Apr. 11, 2002; 67 FR 67095, Nov. 4, 2002] bia, Puerto Rico, the Northern Mariana Islands, Guam, the Virgin Islands of § 53.3 Appraisal of animals or mate- the United States, or any other terri- rials. tory or possession of the United States. (a) Animals affected by or exposed to [61 FR 56882, Nov. 5, 1996, as amended at 67 disease, and materials required to be FR 17610, Apr. 11, 2002; 69 FR 27827, May 17, destroyed because of being contami- 2004; 74 FR 18287, Apr. 22, 2009] nated by or exposed to disease shall be appraised by an APHIS employee and a § 53.2 Determination of existence of representative of the State jointly, or, disease; agreements with States. if the State authorities approve, by an (a) The Administrator is hereby au- APHIS employee alone. thorized to invite the proper State au- (b) The appraisal of animals shall be thorities to cooperate with the Depart- based on the fair market value and ment in the control and eradication of shall be determined by the meat, egg any disease within the meaning of production, dairy or breeding value of § 53.1. such animals. Animals may be ap- (b) Upon agreement of the authori- praised in groups providing they are ties of the State to enforce quarantine the same species and type and pro- restrictions and orders and directives viding that where appraisal is by the properly issued in the control and head each animal in the group is the eradication of such a disease, the Ad- same value per head or where appraisal ministrator is hereby authorized to is by the pound each animal in the agree, on the part of the Department, group is the same value per pound. to cooperate with the State in the con- (c) Appraisals of animals shall be re- trol and eradication of the disease, and, ported on forms furnished by APHIS. except as provided in § 53.11, to pay 50 Reports of appraisals shall show the percent (and in the case of exotic New- number of animals of each species and castle disease or highly pathogenic the value per head or the weight and avian influenza, up to 100 percent, and value by pound. in the case of infectious salmon ane- (d) Appraisals of materials shall be mia, up to 60 percent) of the expenses reported on forms furnished by APHIS. of purchase, destruction and disposi- Reports of appraisals of materials tion of animals and materials required shall, when practicable, show the num- to be destroyed because of being con- ber, size or quantity, unit price, and taminated by or exposed to such disease: Provided, however, That if the ani- 1 Agreements between the Departments and mals were exposed to such disease prior the particular State involved relating to co- to or during interstate movement and operative animal (including poultry) disease are not eligible to receive indemnity prevention, control, and eradication.

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total value of each kind of material ap- stroyed, showing the disposition there- praised. of. [28 FR 5935, June 13, 1963, as amended at 35 [28 FR 5935, June 13, 1963, as amended at 56 FR 13981, Sept. 3, 1970; 36 FR 25217, Dec. 30, FR 51974, Oct. 17, 1991] 1971; 56 FR 51974, Oct. 17, 1991; 68 FR 6343, Feb. 7, 2003] § 53.6 Disinfection of animals. § 53.4 Destruction of animals. Animals of species not susceptible to the disease for which a quarantine has (a) Except as provided in paragraph been established, but which have been (b) of this section, animals infected exposed to the disease, shall be dis- with or exposed to disease shall be infected when necessary by such meth- killed promptly after appraisal and dis- ods as the Administrator shall pre- posed of by burial or burning, unless scribe from time to time. otherwise specifically provided by the Administrator, at his or her discretion. [28 FR 5935, June 13, 1963, as amended at 56 In the case of animals depopulated due FR 51974, Oct. 17, 1991] to spring viremia of carp or infectious salmon anemia, salvageable fish may § 53.7 Disinfection of premises, convey- be sold for rendering, processing, or ances, and materials. any other purpose approved by the Ad- All premises, including barns, cor- ministrator. The proceeds gained from rals, stockyards and pens, and all cars, the sale of the fish will be subtracted vessels, aircraft, and other convey- from any payment from APHIS for ances, and the materials thereon, shall which the producer or owner is eligible be cleaned and disinfected under super- under § 53.2(b) or § 53.11. vision of an APHIS employee whenever (b) [Reserved] necessary for the control and eradi- (c) The killing of animals and the cation of disease. Expenses incurred in burial, burning, or other disposal of connection with such cleaning and dis- carcasses of animals pursuant to the infection shall be shared according to regulations in this part shall be super- the agreement reached under § 53.2 with vised by an APHIS employee who shall the State in which the work is done. In prepare and transmit to the Adminis- the case of low pathogenic avian influ- trator a report identifying the animals enza related to the 2002 disease situa- and showing the disposition thereof. tions in Virginia and Texas associated with the H5 or H7 virus, premises may [28 FR 5935, June 13, 1963, as amended at 56 FR 51974, Oct. 17, 1991; 67 FR 67095, Nov. 4, not be restocked with poultry until at 2002; 68 FR 42569, July 18, 2003; 69 FR 27827, least 7 days following such cleaning May 17, 2004; 71 FR 56323, Sept. 26, 2006] and disinfection, unless the Adminis- trator determines that a shorter or § 53.5 Disinfection or destruction of longer period of time is adequate or materials. necessary to protect new poultry (a) In order to prevent the spread of against infection. disease, materials contaminated by or [68 FR 42569, July 18, 2003] exposed to disease shall be disinfected: Provided, however, That in all cases in § 53.8 Presentation of claims. which the cost of disinfection would exceed the value of the materials or dis- (a) Claims for the following must be infection would be impracticable for presented to APHIS, through the in- any reason, the materials shall be de- spector in charge, on a form approved stroyed, after appraisal as provided in by the Administrator: § 53.3. (1) Compensation for the value of ani- (b) The disinfection or destruction of mals; materials under this section shall be (2) The cost of burial, burning, or under the supervision of an APHIS em- other disposition of animals; ployee who shall prepare and transmit (3) The value of material destroyed; to the Administrator a certificate iden- and tifying all materials which are de- (4) The expenses of destruction.

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(b) [Reserved] try for which the animal or material was destroyed, or in violation of a law (Approved by the Office of Management and Budget under control number 0579–0208) or regulation for the enforcement of which the Secretary enters or has en- [67 FR 67095, Nov. 4, 2002, as amended at 68 tered into a cooperative agreement for FR 42570, July 18, 2003; 71 FR 56323, Sept. 26, the control and eradication of such dis- 2006] ease. § 53.9 Mortgage against animals or ma- (e) The Department will not allow terials. claims arising out of the destruction of fish due to infectious salmon anemia When animals or materials have been (ISA) unless the claimants have agreed destroyed pursuant to the require- in writing to participate fully in the ments contained in this part, any cooperative ISA control program ad- claim for indemnity shall be presented ministered by APHIS and the State of on forms furnished by APHIS on which Maine. Participants in the ISA control the owner of the animals or materials program must: shall certify that the animals or mate- (1) Establish and maintain a veteri- rials covered thereby, are, or are not, nary client-patient relationship with subject to any mortgage as defined in an APHIS accredited veterinarian and this part. If the owner states there is a inform the ISA Program Veterinarian mortgage, forms furnished by APHIS in writing of the name of their accred- shall be signed by the owner and by ited veterinarian at the time the par- each person holding a mortgage on the ticipant enrolls in the ISA program animals or materials, consenting to the and within 15 days of any change in ac- payment of any indemnity allowed to credited veterinarians. the person specified thereon. (2) Cooperate with and assist in peri- [28 FR 5935, June 13, 1963, as amended at 56 odic on-site disease surveillance, test- FR 51974, Oct. 17, 1991] ing, and reporting activities for ISA, which will be conducted by their § 53.10 Claims not allowed. APHIS accredited veterinarian or a (a) The Department will not allow State or Federal official as directed by claims arising under the terms of this the ISA Program Veterinarian. part if the payee has not complied with (3) Develop and implement biosecu- all quarantine requirements. rity protocols for use at all partici- (b) Expenses for the care and feeding pant-leased finfish sites and partici- of animals held for destruction will not pant-operated vessels engaged in aqua- be paid by the Department, unless the culture operations throughout Maine. payment of such expense is specifically A copy of these protocols shall be sub- authorized or approved by the Adminis- mitted to the ISA Program Veteri- trator. narian at the time the participant en- (c) The Department will not allow rolls in the ISA program and within 15 claims arising out of the destruction of days of any change in the protocols. animals or materials unless they shall (4) Develop, with the involvement of have been appraised as prescribed in the participant’s accredited veteri- this part and the owners thereof shall narian and the fish site health man- have executed a written agreement to ager, a site-specific ISA action plan for the appraisals. the control and management of ISA. A (d) The Department will not allow copy of the action plan shall be sub- claims arising out of the destruction of mitted to APHIS for review at the time animals or materials which have been the participant enrolls in the ISA pro- moved or handled by the owner thereof gram and within 15 days of any change or its officer, employee, or agent, act- in the action plan. ing within the scope of his or its office, (5) Participate in the State of employment or agency, in violation of Maine’s integrated pest management a law or regulation administered by (IPM) program for the control of sea the Secretary for the prevention of the lice on salmonids. A copy of the man- introduction into or the dissemination agement plan developed by the partici- within the United States of any com- pant for the State IPM program shall municable disease of livestock or poul- be submitted to APHIS for review at

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the time the participant enrolls in the tible species into their farming estab- ISA program and within 15 days of any lishment. change in the management plan. (Approved by the Office of Management and (6) Submit to the ISA Program Vet- Budget under control number 0579–0192) erinarian at the time the participant [28 FR 5935, June 13, 1963, as amended at 45 enrolls in the ISA program a complete FR 86411, Dec. 31, 1980; 56 FR 51974; 67 FR and current fish inventory information 17611, Apr. 11, 2002; 69 FR 27827, May 17, 2004] for each participant-leased finfish site with site and cage identifiers. Fish in- PART 54—CONTROL OF SCRAPIE ventory information must include the numbers, age, date of saltwater trans- Sec. fer, vaccination status, and previous 54.1 Definitions. therapeutant history for all fish in 54.2 Cooperative agreements and memo- each participant-leased finfish site. randa of understanding with States. (7) Maintain, and make available to the ISA Program Veterinarian upon re- Subpart A—Scrapie Indemnification quest, mortality data for each partici- Program pant-leased finfish site and pen in pro- 54.3 Animals eligible for indemnity pay- duction. ments. (8) Cooperate with and assist APHIS 54.4 Application by owners for indemnity in the completion of biosecurity audits payments. at all participant-leased finfish sites 54.5 Certification by owners. 54.6 Amount of indemnity payments. and participant-operated vessels in- 54.7 Procedures for destruction of animals. volved in salmonid aquaculture. 54.8 Requirements for flock plans and post- (f) The Department will not allow exposure management and monitoring claims arising out of the destruction of plans. fish due to spring viremia of carp (SVC) 54.9 Waiver of requirements for scrapie con- unless the claimants have done the fol- trol pilot projects. lowing: 54.10 Tests for scrapie. 54.11 Approval of laboratories to run official (1) Depopulated all SVC-infected and scrapie tests and official genotype tests. SVC-exposed fish on their property under the supervision of USDA or Subpart B—Scrapie Flock Certification State officials; Program (2) Thoroughly cleaned and dis- 54.20 Administration. infected all affected sites and all af- 54.21 Participation. fected equipment under the supervision 54.22 State scrapie certification boards. of USDA or State officials; AUTHORITY: 7 U.S.C. 8301–8317; 7 CFR 2.22, (3) If an affected site is to be re- 2.80, and 371.4. stocked after cleaning and disinfection, the claimant must have done the fol- SOURCE: 66 FR 43982, Aug. 21, 2001, unless otherwise noted. lowing: (i) Restocked with fish certified free § 54.1 Definitions. of SVC by an APHIS-approved labora- Accredited veterinarian. A veteri- tory or in accordance with the diag- narian approved by the Administrator nostic procedures described in the Of- in accordance with part 161 of this fice of International des Epizooties chapter to perform functions specified Manual of Diagnostic Tests For Aquat- in subchapters B, C, and D of this chap- ic Animals; ter. (ii) Demonstrated that their water Administrator. The Administrator of sources are from first-use spring water, the Animal and Plant Health Inspec- spring water without fish, well water, tion Service or any employee of the ozone or ultraviolet treated surface United States Department of Agri- water, or bore-hole water and are free culture authorized to act for the Ad- of wild carp and any other SVC-suscep- ministrator. tible species; and Animal. A sheep or goat. (iii) Prevented the migration of wild Animal and Plant Health Inspection carp and any other wild SVC-suscep- Service (APHIS). The Animal and Plant

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Health Inspection Service of the United Destroyed. (1) Euthanized by means States Department of Agriculture. other than slaughter, and the carcass APHIS representative. An individual disposed of, by means authorized by employed by APHIS in animal health the Administrator; or activities who is authorized by the Ad- (2) In the case of exposed or high-risk ministrator to perform the function in- animals that are not known to be involved. fected, either euthanized or disposed of Approved laboratory. A laboratory ap- by slaughter; or proved by the Administrator in accord- (3) Moved to a quarantined research ance with § 54.11 to conduct one or facility if the movement has been ap- more scrapie tests, or genotype tests, proved by the Administrator. on one or more tissues. Electronic implant. Any radio fre- Approved test. A test for the diagnosis quency identification implant device of scrapie approved by the Adminis- approved for use in the scrapie program trator for use in the scrapie eradi- by the Administrator. The Adminis- cation or certification program in ac- trator will approve an electronic im- cordance with § 54.10. plant after determining that it is tam- Area veterinarian in charge. The vet- per resistant, not harmful to the ani- erinary official of APHIS who is as- mal, and readable by equipment avail- signed by the Administrator to super- able to APHIS and State representa- vise and perform the official animal tives. health work of APHIS in the State con- Exposed animal. (1) Any animal that cerned. has been in the same flock at the same Breed association and registries. Orga- time as a scrapie-positive female ani- nizations listed in § 151.9 of this chapter mal, excluding limited contacts; or that maintain the permanent records (2) Any animal born in a flock after a of ancestry or pedigrees of animals (in- scrapie-positive animal was born into cluding the animal’s sire and dam), in- that flock or lambed in that flock, if dividual identification of animals, and born before that flock completes the ownership of animals. requirements of a flock plan; or Certificate. An official document (3) Any animal that was commingled issued in accordance with § 79.5 of this with a scrapie-positive female animal chapter by an APHIS representative, during or up to 30 days after she State representative, or accredited vet- lambed, kidded, or aborted, or while a erinarian at the point of origin of an visible vaginal discharge was present, interstate movement of animals. or that was commingled with any other Commingle, commingled, commingling. scrapie-positive female animal for 24 Animals grouped together and having hours or more, including during activi- physical contact with each other, in- ties such as shows and sales or while in cluding contact through a fence, but marketing channels; or not limited contacts. Commingling (4) Any animal in a noncompliant also includes sharing the same section flock. in a transportation unit where there is Exposed flock. Any flock in which a physical contact. scrapie-positive animal was born or Designated scrapie epidemiologist. An lambed. Any flock that currently con- epidemiologist who has demonstrated tains a female high-risk, exposed, or the knowledge and ability to perform suspect animal, or that once contained the functions required and who has a female high-risk, exposed, or suspect been selected by the State animal animal that lambed in the flock and health official and the area veteri- from which tissues were not submitted narian in charge. The regional epi- for official testing and found negative. demiologist and the APHIS National A flock that has completed a post-ex- Scrapie Program Coordinator must posure management and monitoring concur in the selection and appoint- plan following the exposure will no ment of the designated scrapie epi- longer be an exposed flock. demiologist. The designated scrapie Flock. All animals that are main- epidemiologist must satisfactorily tained on a single premises and all ani- complete training designated by mals under common ownership or su- APHIS. pervision on two or more premises with

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animal interchange between the prem- plan to control the spread of scrapie ises. Changes in ownership of part or from, and eradicate scrapie in, an in- all of a flock do not change the iden- fected flock or source flock or to re- tity of the flock or the regulatory reduce the risk of the occurrence of quirements applicable to the flock. scrapie in a flock that contains a high- Animals maintained temporarily on a risk or an exposed animal. As part of a premises for activities such as shows flock plan, the flock owner must pro- and sales or while in marketing chan- vide the facilities and personnel needed nels are not a flock. More than one to carry out the requirements of the flock may be maintained on a single flock plan. The flock plan must include premises if: the requirements in § 54.8(a) through (1) The flocks are enrolled as sepa- (f). rate flocks in the SFCP; or Flock sire. A sexually intact male ani- (2) A State or APHIS representative mal that has ever been used for breed- determines, based upon examination of ing in a flock. flock records, that: High-risk animal. A sexually intact (i) There is no interchange of animals animal, excluding male sheep that between the flocks; have tested RR at codon 171 and AA at (ii) The flocks never commingle and codon 136 using an official genotype are kept at least 30 feet apart at all test, that is: times or are separated by a solid wall (1) The progeny of a scrapie-positive through, over, or under which fluids dam; or cannot pass and through which contact (2) Born in the same flock during the cannot occur; same lambing season as progeny of a (iii) The flocks have separate flock scrapie-positive dam, unless the prog- records and identification; eny of the scrapie-positive dam are (iv) The flocks have separate lambing from separate contemporary lambing facilities, including buildings and pas- groups; or tures, and a pasture or building used (3) Born in the same flock during the for lambing by one flock is not used by same lambing season that a scrapie- the other flock at any time; and positive animal was born, or during (v) The flocks do not share equip- any subsequent lambing season, if born ment without cleaning and disinfection before that flock completes the rein accordance with § 54.7(e). Additional quirements of a flock plan; or guidance on acceptable means of clean- (4) An exposed female sheep that has ing and disinfection is also available in not tested QR, HR, or RR at codon 171 the Scrapie Flock Certification Pro- using an official genotype test. gram standards and the Scrapie Eradi- Infected flock. The flock of origin of a cation Uniform Methods and Rules. female animal that a State or APHIS Flock of origin. The flock in which an representative has determined to be a animal most recently resided in which scrapie-positive animal; or any flock in it either was born, gave birth, or was which a State or APHIS representative used for breeding purposes. The deter- has determined that a scrapie-positive mination of an animal’s flock of origin female animal has resided unless an may be based either on the physical epidemiologic investigation conducted presence of the animal in the flock, the by a State or APHIS representative presence of official identification on shows that the animal did not lamb or the animal traceable to the flock, the abort in the flock. A flock will no presence of other identification on the longer be considered an infected flock animal that is listed on the bill of sale, after it has completed the require- or other evidence, such as registry ments of a flock plan. records. Limited contacts. Incidental contacts Flock plan. A written flock manage- between animals from different flocks ment agreement signed by the owner of off the flock’s premises such as at fairs, a flock, the accredited veterinarian, if shows, exhibitions and sales; between one is employed by the owner, and a ewes being inseminated, flushed, or im- State or APHIS representative in planted; or between rams at ram test which each participant agrees to un- or collection stations. Embryo transfer dertake actions specified in the flock and artificial insemination equipment

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and surgical tools must be sterilized premises affected by scrapie, individual between animals for these contacts to animal identification and premises be considered limited contacts. Lim- identification data, and other data to ited contacts do not include any con- support the Scrapie Eradication Pro- tact, incidental or otherwise, with ani- gram and the Scrapie Flock Certifi- mals in the same flock or with a fe- cation Program. male animal during or up to 30 days National Veterinary Services Labora- after she lambed, kidded or aborted or tories (NVSL). The National Veterinary when there is any visible vaginal dis- Services Laboratories, APHIS, U.S. De- charge. Limited contacts do not in- partment of Agriculture, or an NVSL clude any activity where uninhibited cooperating or contract laboratory. contact occurs, such as sharing an en- Noncompliant flock. (1) Any source or closure, sharing a section of a trans- infected flock whose owner declines to port vehicle, or residing in other flocks enter into a flock plan or post-exposure for breeding or other purposes. Exam- management and monitoring plan ples of limited contacts may be found agreement within 30 days of being so in the Scrapie Flock Certification Pro- designated, or whose owner is not in gram standards. compliance with either agreement; Live-animal screening test. Any test for (2) Any exposed flock whose owner the diagnosis of scrapie in a live ani- fails to make animals available for mal that is approved by the Adminis- testing within 60 days of notification, trator as usually reliable but not defin- or as mutually agreed, or whose owner itive for diagnosing scrapie, and that is fails to submit required postmortem conducted in a laboratory approved by samples; the Administrator. 1 (3) Any flock whose owner has mis- Mortgage. Any mortgage, lien, or represented, or who employs a person other security or interest held by any who has misrepresented, the scrapie person other than the one claiming in- status of an animal or any other infor- demnity. mation on a certificate, permit, owner National Scrapie Database. A database statement, or other official document designated by the Administrator in within the last 5 years; or which APHIS and State animal health (4) Any flock whose owner or man- agencies cooperatively enter data con- ager has moved, or who employs a per- cerning scrapie outbreaks, flocks and son who has moved, an animal in violation of this chapter within the last 5 1 The names and addresses of laboratories years. approved by the Administrator to conduct Official genotype test. Any test to de- live-animal screening tests will be published termine the genotype of a live or dead in the Notices Section of the FEDERAL REG- animal that is conducted at either an ISTER. A list of approved laboratories is also available upon request from the Animal and approved laboratory or at the National Plant Health Inspection Service, Veterinary Veterinary Services Laboratories, Services, National Animal Health Programs when the animal is officially identified Staff, 4700 River Road Unit 43, Riverdale, MD and the samples used for the test are 20737–1235. State, Federal, and university lab- collected and shipped to the laboratory oratories will be approved by the Adminis- by either an accredited veterinarian or trator when he or she determines that the a State or APHIS representative laboratory: (a) Employs personnel trained by Official test. Any test for the diag- the National Veterinary Services Labora- tories assigned to supervise the testing; (b) nosis of scrapie in a live or dead animal follows standard test protocols; (c) meets that is approved by the Administrator check test proficiency requirements; and (d) for that use and conducted either at an will report all test results to State and Fed- approved laboratory or at the National eral animal health officials. Before the Ad- Veterinary Services Laboratories. ministrator may withdraw approval of any Owner. A person, partnership, com- laboratory for failure to meet any of these pany, corporation, or any other legal conditions, the Administrator must give entity who has legal or rightful title to written notice of the proposed withdrawal to the director of the laboratory and must give animals, whether or not they are sub- the director an opportunity to respond. If ject to a mortgage. there are conflicts as to any material fact, a Post-exposure management and moni- hearing will be held to resolve the conflicts. toring plan. A written agreement signed

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by the owner of a flock, any accredited Scrapie-positive animal. An animal for veterinarian employed by the owner, which a diagnosis of scrapie has been and a State or APHIS representative in made by the National Veterinary Serv- which each participant agrees to un- ices Laboratories or another labora- dertake actions specified in the agree- tory authorized by the Administrator ment to monitor for the occurrence of to conduct scrapie tests in accordance scrapie in the flock for at least 5 years with this part, through: after the last high-risk or scrapie-posi- (1) Histopathological examination of tive animal is removed from the flock central nervous system (CNS) tissues or after the last exposure of the flock from the animal for characteristic mi- to a scrapie-positive animal, unless croscopic lesions of scrapie; otherwise specified by a State or (2) The use of proteinase-resistant APHIS representative. As part of a protein analysis methods including but post-exposure management and moni- not limited to immunohistochemistry toring plan, the flock owner must pro- and/or western blotting on CNS and/or vide the facilities and personnel needed peripheral tissue samples from a live or to carry out the requirements of the a dead animal for which a given meth- plan. The plan must include the re- od has been approved by the Adminis- quirements in § 54.8. trator for use on that tissue; Scrapie control pilot project. A pilot (3) Bioassay; project authorized by the Adminis- (4) Scrapie associated fibrils (SAF) trator in writing, designed to test or detected by electron microscopy; or improve program procedures or to fa- (5) Any other test method approved cilitate research, in order to control by the Administrator in accordance 3 and eradicate scrapie. In addition to with § 54.10. APHIS, participants may include State Separate contemporary lambing groups. animal health agencies, flock owners, To be a separate contemporary and other parties as necessary. lambing group, the group must be Scrapie Eradication Program. The co- maintained separately such that the operative State-Federal program ad- animals cannot come into physical contact with other lambs, kids, ewes or ministered by APHIS and Consistent States to control and eradicate scrapie. Scrapie Eradication Uniform Methods www.aphis.usda.gov/vs/scrapie, or from the Animal and Plant Health Inspection Service, and Rules (UM&R). Cooperative proce- National Animal Health Programs Staff, 4700 dures and standards adopted by APHIS River Road Unit 43, Riverdale, MD 20737–1235. and Consistent States for controlling 3 The names and addresses of laboratories and eradicating scrapie. The UM&R approved by the Administrator to conduct will be reviewed at least annually by tests are published in the Notices Section of representatives of the livestock indus- the FEDERAL REGISTER. A list of approved try and appropriate State and Federal laboratories is also available upon request from the Animal and Plant Health Inspec- agencies and the public and will be re- tion Service, Veterinary Services, National vised, and published as needed by Animal Health Programs Staff, 4700 River APHIS. Road Unit 43, Riverdale, MD 20737–1235. Scrapie Flock Certification Program State, Federal, and university laboratories (SFCP). The cooperative Federal-State- will be approved by the Administrator when industry voluntary program for the he or she determines that the laboratory: (a) control of scrapie conducted in accord- Employs personnel trained by the National Veterinary Services Laboratories assigned to ance with this subpart. supervise the testing; (b) follows standard Scrapie Flock Certification Program test protocols; (c) meets check test pro- standards. Cooperative procedures and ficiency requirements; and (d) will report all standards adopted by APHIS and State test results to State and Federal animal scrapie certification boards for reduc- health officials. Before the Administrator ing the incidence and controlling the may withdraw approval of any laboratory for spread of scrapie through flock certifi- failure to meet any of these conditions, the 2 Administratr must give written notice of the cation. proposed withdrawal to the director of the laboratory and must give the director an op- 2 Individual copies of the Scrapie Flock portunity to respond. If there are conflicts as Certification Program standards may be ob- to any material fact, a hearing will be held tained on the World Wide Web at URL http:// to resolve the conflict.

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does or birth fluids or placenta from an approved genotyping laboratory, or other ewes or does. This separate main- if DNA collection and storage are re- tenance must preclude contact through quired for breed registration and the a fence, during lambing and for 60 days breed registration has appropriate safe- following the date the last lamb or kid guards in place to ensure the integrity is born in a lambing season, and must of the banking process, the owner may preclude using the same lambing facil- request verification of the animal’s ity as other ewes or does, unless the identity based on DNA comparison if lambing facility is cleaned and dis- adequate records and identification infected under supervision by an have been maintained by the owner and APHIS representative, State represent- the repository to show that the ative, or an accredited veterinarian be- archived DNA is that of the animal tween lambings in accordance with that has been traced to the flock. The § 54.7(e). Additional guidance on accept- owner will be responsible for all costs able means of cleaning and disinfection for the DNA comparison. A flock will is also available in the Scrapie Flock no longer be a source flock after it has Certification Program standards and completed the requirements of a flock the Scrapie Eradication Uniform Meth- ods and Rules. The flock owner must plan. maintain adequate records to docu- State. Each of the 50 States, the Dis- ment which animals were maintained trict of Columbia, the Northern Mar- in each contemporary lambing group iana Islands, Puerto Rico, and all terri- and to document when cleaning and tories or possessions of the United disinfection was performed and who su- States. pervised it. State representative. An individual em- Slaughter channels. Animals in ployed in animal health activities by a slaughter channels include any animal State or a political subdivision of a that is sold, transferred, or moved ei- State and who is authorized by the ther directly to a slaughter facility, to State or political subdivision to per- an individual for custom slaughter, or form the function involved. for feeding for the express purpose of Suspect animal. An animal will be des- improving the animals’ condition for ignated a suspect animal in accordance movement to slaughter. Any sexually with § 79.4 of this chapter if it is: intact animal that is commingled with (1) A sheep or goat that exhibits any breeding animals or that has been bred of the following possible signs of is not in slaughter channels. When sell- scrapie and that has been determined ing animals for slaughter, owners to be suspicious for scrapie by an ac- should note on the bill of sale that the credited veterinarian or a State or animals are sold only for slaughter. APHIS representative: Weight loss de- Source flock. A flock in which a State spite retention of appetite; behavioral or APHIS representative has deter- abnormalities; pruritus (itching); wool mined that at least one animal was born that was diagnosed as a scrapie- pulling; biting at legs or side; lip positive animal at an age of 72 months smacking; motor abnormalities such as or less. The determination that an ani- incoordination, high stepping gait of mal was born in a flock will be based forelimbs, bunny hop movement of rear on such information as the presence of legs, or swaying of back end; increased official identification on the animal sensitivity to noise and sudden move- traceable to the flock, the presence of ment; tremor, ‘‘star gazing,’’ head other identification on the animal that pressing, recumbency, or other signs of is listed on the bill of sale, or other evi- neurological disease or chronic wast- dence, such as registry records, to show ing. that a scrapie-positive animal was born (2) A sheep or goat that has tested in the flock, combined with the ab- positive for scrapie or for the pro- sence of records indicating that the teinase resistant protein associated animal was purchased from outside and with scrapie on a live-animal screening added to the flock. If DNA from the test or any other test, unless the ani- animal was previously collected by an mal is designated a scrapie-positive accredited veterinarian and stored at animal.

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(3) A sheep or goat that has tested in- (1) Destruction of high-risk animals; conclusive or suggestive on an official (2) Destruction of animals based on test for scrapie. an epidemiologic investigation, when Unofficial test. Any test for the diag- the Administrator determines that the nosis of scrapie or for the detection of destruction of these animals will con- the proteinase resistant protein associ- tribute to the eradication of scrapie; ated with scrapie in a live or dead ani- (3) Destruction of live scrapie-posi- mal that either has not been approved tive animals; by the Administrator or that was not (4) Destruction of animals that test conducted at an approved laboratory or positive on a live-animal screening at the National Veterinary Services test; and Laboratories. (5) Destruction of suspect animals that are destroyed at the request of an § 54.2 Cooperative agreements and APHIS representative. memoranda of understanding with States. (b) No indemnity will be paid for an animal if the owner of the animal fails APHIS will execute cooperative to provide APHIS, within 30 days of re- agreements and/or memoranda of un- quest, animal registration certificates, derstanding with the animal health sale and movement records, or other agency of any State in order to coop- records requested in accordance with eratively administer the Scrapie Eradi- § 54.5. No indemnity will be paid until cation Program and the Scrapie Flock the premises, including all structures, Certification Program within that holding facilities, conveyances, and State. These agreements will describe materials contaminated because of oc- the respective roles of APHIS and cupation or use by the depopulated ani- State personnel in implementing the mals, have been properly cleaned and Scrapie Eradication Program and the disinfected in accordance with § 54.7(e). Scrapie Flock Certification Program. Additional guidance on acceptable Each agreement may specify the finan- means of cleaning and disinfection is cial, material, and personnel resources also available in the Scrapie Flock Cer- to be committed to these programs and tification Program standards and the other scrapie control measures by Scrapie Eradication Uniform Methods APHIS and the State; assign specific and Rules. Premises or portions of activities related to the control of premises may be exempted from the scrapie within a State to APHIS or cleaning and disinfecting requirements State personnel; establish schedules for if a designated scrapie epidemiologist APHIS representatives or State rep- determines, based on epidemiologic in- resentatives to visit flocks; establish vestigation, that cleaning and disinfec- procedures for maintaining and sharing program records specified in this part, tion of such buildings, holding facili- and specify other responsibilities of ties, conveyances, or other materials State representatives and APHIS rep- on the premises will not significantly resentatives in support of the Scrapie reduce the risk of the spread of scrapie, Eradication Program and the Scrapie either because effective disinfection is Flock Certification Program. not possible or because the normal operations on the premises prevent trans- (Approved by the Office of Management and mission of scrapie. No indemnity will Budget under control number 0579–0101) be paid to an owner if the owner assembled or increased his flock for the pur- Subpart A—Scrapie pose of collecting or increasing indem- Indemnification Program nity. § 54.3 Animals eligible for indemnity § 54.4 Application by owners for in- payments. demnity payments. (a) Indemnity may be paid for an ani- (a) Normally, an application for in- mal only after the owner of the animal demnification will be initiated by a has applied for indemnification and State or APHIS representative who is been approved in accordance with § 54.4. working with the owner of a flock that Indemnity may be paid only for the fol- has already been determined to be an lowing: infected flock or source flock, or that

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is already under a State movement re- (a) The owner will make available for striction. In such cases, the flock review upon request by a State or owner will confirm information about APHIS representative all bills of sale, the flock’s eligibility for indemnity pedigree registration certificates, and that is contained in the application other records regarding movement of submitted by the State or APHIS rep- animals into and from the flock; resentative. However, the owner of any (b) If the owner maintains any flock flock may apply directly to receive in- after the payment of indemnity or ac- demnification by submitting to the Ad- quires a new flock that is housed on ministrator a written request con- the same premises within 5 years after taining the following information: the last high-risk or scrapie-positive (1) Name, address, and social security animal is removed, the owner will number of the flock owner; maintain the flock in accordance with (2) Number and breed(s) of animals in a post-exposure management and moni- the flock, including a current inven- toring plan for 5 years; tory; (c) If the animal for which indemnity (3) Location of flock premises; is paid is subject to any mortgage, the owner consents to the payment of the (4) Reasons the owner believes ani- indemnity, up to the value of the mort- mals in his or her flock may be eligible gage, to the person(s) holding the for indemnification, including any di- mortgage; agnosis of scrapie made for animals in (d) That the animal may be removed the flock; any signs of scrapie observed to a U.S. Department of Agriculture fa- in the flock by the owner; and any cility or a quarantined research facil- movement of animals into the flock ity, slaughtered, or euthanized and from flocks infected with or exposed to necropsied and tissues removed for di- scrapie; agnostic or other purposes. (5) A copy of the registration papers issued in the name of the owner for any § 54.6 Amount of indemnity payments. registered animals in the flock (reg- (a) Indemnity paid for sheep in ac- istration papers are not required for cordance with § 54.3 will be set based on the payment of indemnity for animals the following price reports published that are not registered). If the registra- by the Agricultural Marketing Service tion papers are unavailable, the owner (AMS). If pricing information is un- may choose to accept a lesser indem- available from these markets during a nity in accordance with § 54.6(b)(2) or given week or month or if the numbers the area veterinarian in charge may of animals sold are too low to give an grant a 60-day extension or the Admin- accurate market value, the preceding istrator may grant an extension longer week or month’s value will be used. than 60 days for the presentation of The AMS reports from the most recent registration papers; and week or month prior to the date APHIS (6) Signed release letters addressed to offers to pay an owner indemnity shall any sheep or goat registry associations be used to calculate the indemnity for that maintain records of the owner’s that owner’s sheep: sheep or goats requesting the associa- (1) The weekly weighted average tions to release to APHIS all records Choice/Prime slaughter lamb price per maintained by the association on sheep pound at Greeley, CO; or goats currently or formerly owned (2) The weekly weighted average by the applicant. Utility slaughter ewe price per pound (b) APHIS will evaluate each applica- at San Angelo, TX; tion to determine whether the owner’s (3) The monthly weighted average flock contains animals eligible for in- commercial western ewe lamb replace- demnity in accordance with § 54.3. ment price per head; (4) The monthly weighted average § 54.5 Certification by owners. commercial western yearling ewe re- Before any indemnity is paid to an placement price per head; owner, the owner must sign a written (5) The monthly weighted average agreement with APHIS, certifying the commercial western running age ewe following: price per head.

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(6) The monthly weighted average ceding 12 to 24 months in determining commercial western aged ewe price per the indemnity amount, but the indem- head. nity shall not exceed the maximum in- (b) For animals under 1 year of age, demnity calculated for registered sheep the basic indemnity shall equal the in accordance with this section. price per pound from paragraph (a)(1) (1) If records and identification are of this section times the greater of 50 inadequate to determine the actual age lbs or the actual weight of the animal; of animals, an APHIS or State rep- except that, for ewe lambs under 1 year resentative will count all sexually in- of age, the indemnity shall equal the tact animals that are apparently under per-head price from paragraph (a)(3) of 1 year of age, and those that are appar- this section if that price is higher. For ently at least 1 and under 2 years of sexually intact sheep 8 years of age or age, based on examination of their older and castrated animals 1 year of teeth, and the indemnity for these ani- age or older, the basic indemnity shall mals will be calculated. The total num- equal the price per pound from para- ber of these animals will be subtracted graph (a)(2) of this section times 150, from the total number of sexually in- based on an average weight of 150 lbs. tact animals in the group to be indem- For sexually intact sheep at least 1 nified, and indemnity for the remain- year of age and under 2 years of age, der will be calculated based on the as- the indemnity shall equal the greater sumption that the remainder of the of the price per head from paragraph flock is 80 percent aged 2 to 6 years and (a)(4) of this section, or the price per 20 percent aged 6 to 8 years. pound from paragraph (a)(2) of this sec- (2) Any animal that is not registered tion times 150, based on an average at the time indemnity is first offered, weight of 150 lbs. For sexually intact but is eligible to be registered, will re- sheep at least 2 years of age and under ceive the registered animal premium 6 years of age, the basic indemnity reduced by $50. shall equal the greater of the price per (c) For animals destroyed by slaugh- head from paragraph (a)(5) of this sec- ter, the owner will retain the salvage tion or the price per pound from para- value (the amount paid by a slaughter graph (a)(2) of this section times 150, plant for the animal) of the animals in based on an average weight of 150 lbs. lieu of receiving the base indemnity. If For sexually intact sheep at least 6 the salvage value, less transport costs, years of age and under 8 years of age, is less than the base indemnity, APHIS the basic indemnity will equal the will pay the owner the difference. greater of the price per head from para- APHIS will also indemnify the owner graph (a)(6) of this section or the price in the amount of any registered animal per pound from paragraph (a)(2) of this or flock sire premiums for which the section times 150, based on an average animal qualifies. weight of 150 lbs. A premium shall be (d) If the owner disagrees with the added to the basic indemnity for each average weight estimate, he may have registered animal, equal to $100 for the sheep weighed at a public scale at each registered animal under 1 year of his own expense, provided that the age, $200 for each registered animal at sheep may not come in contact with least 1 year of age and under 4 years of other sheep or goats during movement age, and $100 for each registered animal to the public scales, and will be paid at least 4 years of age and under 8 based on the actual weight times the years of age. An additional premium of AMS weekly average price. $50 will be added to the basic indem- (e) Indemnity will be paid to an nity for each flock sire. The owner owner only for animals actually in a must provide adequate records to qual- flock at the time indemnity is first of- ify for these premiums. When the ani- fered. Animals removed from the flock mals to be indemnified are goats, or as part of a post-exposure management are sheep that fall outside the classes and monitoring plan will be paid in- covered previously in this paragraph, demnity based on the AMS average the Administrator may take into con- prices at the time an APHIS represent- sideration the producer’s purchase ative designates the animals for re- records and sales records for the pre- moval.

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§ 54.7 Procedures for destruction of determines that doing so will con- animals. tribute to scrapie eradication. For re- (a) Scrapie-positive and suspect ani- imbursement to be made, the owner of mals for which indemnification is the animals must present the area vet- sought must be destroyed on the prem- erinarian in charge with a copy of ei- ises where they are held, pastured, or ther a receipt for expenses paid or a penned at the time indemnity is ap- bill for services rendered. Any bill for proved or moved to an approved re- services rendered by the owner must search facility, unless the APHIS rep- not be greater than the normal fee for resentative involved approves in ad- similar services provided by a commer- vance of destruction moving the ani- cial hauler or disposal facility. mals to another location for destruc- (e) Cleaning and disinfection of prem- tion. Animals that are not scrapie-posi- ises and equipment. When required, tive or suspect animals for which in- cleaning and disinfection shall be con- demnification is sought may be: ducted under the supervision of a State (1) Slaughtered when moved in accordance with part 79 of this chapter or APHIS representative as follows. and with the prior written approval of Additional guidance on acceptable the APHIS representative involved; means of cleaning and disinfection is (2) Destroyed on the premises where also available in the Scrapie Flock Cer- they are held, pastured, or penned at tification Program standards and the the time indemnity is approved; Scrapie Eradication Uniform Methods (3) Moved to an approved research fa- and Rules: cility; or (1) Drylot areas. When required, re- (4) Moved to another location for de- move the manure and top 1–2 inches of struction if an APHIS representative soil to reduce contamination. Bury, till approves the movement in advance. under, or compost the removed mate- (b) The carcasses of animals de- rial in areas not accessed by domestic stroyed in accordance with this section animals or wildlife. are authorized by the Administrator to (2) Cement, wood, metal, and other non- be buried, incinerated, or disposed of earth surfaces, tools, equipment, instru- by other methods in accordance with ments, feed, hay, bedding, and other ma- local, State, and Federal laws. The car- terials. Remove all organic material casses of scrapie-positive and suspect and compost or incinerate. Clean and animals may not be processed for wash all surfaces, tools, equipment, human or animal food. (c) The destruction of animals and and instruments using hot water and disposition of their carcasses in accord- detergent. Allow all surfaces, tools, ance with this part must be monitored equipment, and instruments to dry by an APHIS representative who will completely before disinfecting and prepare and transmit to the Adminis- sanitizing using the following methods: trator a report identifying the animals (i) Incinerate items by high-tempera- and showing their disposition. ture incineration methods; (d) APHIS may pay the reasonable (ii) Autoclave instruments, small costs of disposal for scrapie-positive tools, and other items at 136 °C for 1 and suspect animals that are indem- hour; nified. To obtain reimbursement for (iii) To clean dry surfaces, apply a 2- disposal costs, animal owners must ob- percent chlorine bleach solution at tain written approval of the disposal room temperature (at least 18.3 °C for 1 costs from APHIS, prior to disposal. hour, or apply a 1-molar solution of so- The Administrator may also authorize dium hydroxide (approximately 5 oz. of payment of up to half the reasonable sodium hydroxide dissolved in l gallon disposal costs for animals that are eli- water) at room temperature for at gible to be destroyed by slaughter least 1 hour. Note: A 2-molar solution under this section but for which slaughter is not a practical or cost effi- is more effective than a 1-molar solu- cient means of disposal; Provided that, tion and should be used when cir- APHIS may pay more than one-half of cumstances permit. the expenses when the Administrator

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§ 54.8 Requirements for flock plans ative, APHIS representative, or an ac- and post-exposure management and credited veterinarian, and not remove monitoring plans. them from a flock without written per- (a) The owner of the flock or his or mission of a State or APHIS represent- her agent must identify all animals 1 ative: year of age or over within the flock. (1) Any sheep or goat exhibiting All animals less than 1 year of age weight loss despite retention of appe- must be identified when a change of tite; behavioral abnormalities; pruritus ownership occurs, with the exception of (itching); wool pulling; biting at legs or those animals under 1 year of age mov- side; lip smacking; motor abnormali- ing within slaughter channels that ties such as incoordination, high step- must be identified in accordance with ping gait of forelimbs, bunny hop §§ 79.2 and 79.3 of this chapter. The form movement of rear legs, swaying of back of identification must be an electronic end; increased sensitivity to noise and implant, flank tattoo, ear tattoo, or sudden movement; tremor, ‘‘star gaz- tamper-resistant ear tag approved for ing,’’ head pressing, recumbency, or this use by APHIS. In the case of goats, other signs of neurological disease or the form of identification may alter- chronic wasting illness; and natively be a tail fold tattoo. The official identification must provide a (2) Any sheep or goat in the flock unique identification number that is that has tested positive for scrapie or applied by the owner of the flock or his for the proteinase resistant protein as- or her agent and must be linked to that sociated with scrapie on a live-animal flock in the National Scrapie Database. screening test or any other test. (b) Upon request by a State or APHIS (f) Requirements for flock plans only. representative, the owner of the flock (1) An epidemiologic investigation or his or her agent must have an ac- must be conducted to identify high- credited veterinarian collect tissues risk and exposed animals that cur- from animals for scrapie diagnostic rently reside in the flock or that pre- purposes and submit them to a labora- viously resided in the flock, and all tory designated by a State or APHIS high-risk animals, scrapie-positive ani- representative. mals, and suspect animals must be re- (c) Upon request by a State or APHIS moved from the flock. The animals representative, the owner of the flock must be removed either by movement or his or her agent must make animals to an approved research facility or by in the flock and the records required to euthanization and disposal of the car- be kept as a part of these plans avail- casses by burial, incineration, or other able for inspection. methods in accordance with local, (d) The owner of the flock or his or State, and Federal laws, or, in the case her agent must meet requirements of high-risk animals, by movement to found necessary by a State or APHIS slaughter in accordance with the provi- representative to monitor for scrapie sions of part 79 of this chapter, or upon and to prevent the recurrence of request in individual cases by another scrapie in the flock and to prevent the means determined by the Adminis- spread of scrapie from the flock. These other requirements may include, but trator to be sufficient to prevent the are not limited to: Utilization of a live- spread of scrapie; animal screening test; restrictions on (2) The premises of a flock under a the animals that may be moved from flock plan must be cleaned and dis- the flock; segregated lambing; cleaning infected in accordance with § 54.7(e). and disinfection of lambing facilities; Additional guidance on acceptable and/or education of the owner of the means of cleaning and disinfection is flock and personnel working with the also available in the Scrapie Flock Cer- flock in techniques to recognize clin- tification Program standards and the ical signs of scrapie and to control the Scrapie Eradication Uniform Methods spread of scrapie. and Rules. Premises or portions of (e) The owner of the flock or his or premises may be exempted from the her agent must immediately report the cleaning and disinfecting requirements following animals to a State represent- if a designated scrapie epidemiologist

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determines, based on epidemiologic in- toring plans. A designated scrapie epi- vestigation, that cleaning and disinfec- demiologist may modify the require- tion of such buildings, holding facili- ments of a flock plan or post-exposure ties, conveyances, or other materials management and monitoring plan to on the premises will not significantly accommodate the situation of a par- reduce the risk of the spread of scrapie, ticular flock if the modified plan re- either because effective disinfection is quires: not possible or because the normal op- (1) That a State or APHIS represent- erations on the premises prevent trans- ative inspect the flock and flock mission of scrapie. No area where a records at least once every 12 months; scrapie-positive animal lambed or (2) The testing of animals at a level aborted may be exempted; that will result in 99 percent con- (3) The owner of the flock, or his or fidence of detecting a 1 percent preva- her agent, must request breed associa- lence in the flock (for flock plans tions and registries, livestock markets, only); and packers to disclose records to (3) The official identification of all APHIS representatives or State rep- animals upon leaving the premises of resentatives, to be used to identify the flock for purposes other than source flocks and trace exposed ani- slaughter and of all animals over 18 mals, including high-risk animals; and months of age (as evidenced by the (4) The flock owner must agree to eruption of the second incisor) in conduct post-exposure management slaughter channels; and and monitoring. (4) Recordkeeping including: (g) Requirements for post-exposure management and monitoring plans only: The (i) For acquired animals, the date of plan must require that a State or acquisition, name and address of the APHIS representative inspect the flock person from whom the animal was ac- and flock records at least once every 12 quired, any identifying marks or tags months. The owner of the flock or his present on the animal including the or her agent must maintain, and keep animal’s individual official identifica- for a minimum of 5 years after an ani- tion number from its electronic im- mal dies or is otherwise removed from plant, flank tattoo, ear tattoo, tamper a flock, the following records for each resistant ear tag, or, in the case of animal in the flock: goats, tail fold tattoo, and any sec- (1) Any identifying marks or tags ondary form of identification the present on the animal, including the owner of the flock may choose to main- animal’s individual official identifica- tain. tion number from its electronic im- (ii) For animals leaving the premises plant, flank tattoo, ear tattoo, tamper of the flock, the disposition of the ani- resistant ear tag, or, in the case of mal, including, for those animals that goats, tail fold tattoo, and any sec- are required to be identified, any iden- ondary form of identification the tifying marks or tags present on the owner of the flock may choose to main- animal, including the animal’s indi- tain; vidual official identification number (2) Sex, year of birth, breed, and from its electronic implant, flank tat- when possible to determine, the fol- too, ear tattoo, tamper resistant ear lowing: sire, dam, and offspring of the tag, or, in the case of goats, a tail fold animal; tattoo, and any secondary form of iden- (3) Date of acquisition and previous tification the owner of the flock may flock, if the animal was not born in the choose to maintain, the date and cause flock; and of death, if known, or date of removal (4) Disposition of the animal, includ- from the flock and name and address of ing the date and cause of death, if the person to whom the animal was known, or date of removal from the transferred. flock and name and address of the per- (iii) Maintenance of these records for son to whom the animal was trans- 5 years. ferred. (5) Requirements equivalent to those (h) Modification of flock plans and contained in paragraphs (b), (c), (d), post-exposure management and moni- and (e) of this section.

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(i) Post-exposure management and mon- (5) Any other data requested by the itoring plans for exposed flocks that were Administrator to determine the suit- not source flocks and in which a scrapie ability of the test for program use. infected animal did not lamb. A des- (b) To be approved, a scrapie test ignated scrapie epidemiologist shall de- must be able to be replicated at the Na- termine the testing and monitoring re- tional Veterinary Services Labora- quirements for these flocks based on tories, or another reliable, timely, and the exposure risk of the individual cost effective method of check testing flock. must be available to APHIS. (c) A test or combination of tests § 54.9 Waiver of requirements for may be approved for the identification scrapie control pilot projects. of suspect animals, for the identifica- The Administrator may waive the tion of scrapie-positive animals, or for following requirements of this part for other purposes such as flock certifi- participants in a scrapie control pilot cation. For a test to be approved for project by recording the requirements the identification of scrapie-positive waived in the scrapie control pilot animals, the test must have a speci- project plan: ficity comparable to the specificity of (a) The determination that an animal the currently approved tests. For a test is a high-risk animal, if the scrapie to be approved as a live animal screen- control pilot project plan contains ing test for the identification of sus- testing or other procedures that indi- pect animals, the test must be usually cate that an animal, despite meeting reliable but need not be definitive for the definition of high-risk animal, is diagnosing scrapie. unlikely to spread scrapie; and (d) Specific guidelines for use of ap- (b) The requirement that high-risk proved scrapie tests within the Scrapie animals must be removed from a flock Eradication Program or Scrapie Flock if the scrapie control pilot project plan Certification Program will be added to contains alternative procedures to pre- this part as tests are approved and will vent the further spread of scrapie with- also be contained in the Scrapie Eradi- out removing high-risk animals from cation UM&R and the Scrapie Flock the flock. Certification Program standards based on the characteristics of the test, in- § 54.10 Tests for scrapie. cluding specificity, sensitivity, and predictive value. (a) The Administrator may approve (e) If an owner elects to have an unof- new tests for the diagnosis of scrapie ficial test conducted on an animal for conducted on live or dead animals for scrapie, or for the proteinase resistant use in the Scrapie Eradication Pro- protein associated with scrapie, and gram. The Administrator will base the that animal tests positive to such a approval or disapproval of a test on the test, the animal will be designated a evaluation by APHIS and, when appro- suspect animal, unless: priate, outside scientists, of: (1) The test was run as part of a bona (1) A standardized test protocol that fide research protocol designed to must include a description of the test, evaluate an unapproved test in which a description of the reagents, mate- the owner is not informed of the test rials, and equipment used for the test, result; or the test methodology, and any control (2) The test protocol includes appro- or quality assurance procedures; priate measures to prevent the spread (2) Data to support reproducibility, of scrapie. that is, the ability to reproduce the same result repeatedly on a given sam- § 54.11 Approval of laboratories to run ple; official scrapie tests and official (3) Data to support suitability, that genotype tests. is, data to show that similar results (a) State, Federal, and university can be produced when the test is run at laboratories, or in the case of genotype other laboratories; tests, private laboratories will be ap- (4) Data to support the sensitivity proved by the Administrator when he and specificity of the test; and or she determines that the laboratory:

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(1) Employs personnel assigned to su- industry, including owners of flocks, pervise the testing who are qualified to slaughtering and rendering establish- conduct the test based on education, ments, and breed associations and reg- training, and experience and who have istries; accredited veterinarians; and been trained by the National Veteri- State governments. APHIS coordinates nary Services Laboratories (NVSL) or with State scrapie certification boards who have completed equivalent train- and State animal health agencies to ing approved by NVSL; encourage flock owners to certify their (2) Has adequate facilities and equip- flocks as free of scrapie by being in ment to conduct the test; continuous compliance with the (3) Follows standard test protocols; Scrapie Flock Certification Program (4) Meets check test proficiency re- standards. quirements; (5) Meets recordkeeping require- § 54.21 Participation. ments; (6) Will retain records, slides, blocks, Any owner of a sheep or goat flock and other specimens from all cases for may apply to enter the Scrapie Flock at least 1 year and from positive cases Certification Program by sending a for 5 years; written request to a State scrapie cer- (7) Will allow APHIS to inspect the tification board or to the area veteri- laboratory without notice during nor- narian in charge. A notice containing a mal business hours; and current list of flocks participating in (8) Will report all test results to the Scrapie Flock Certification Pro- State and Federal animal health offi- gram, and the certification status of cials within agreed timeframes. An in- each flock, may be obtained from the spection may include, but is not lim- APHIS web site at URL http:// ited to, review and copying of records, www.aphis.usda.gov/vs/scrapie. A list of examination of slides, observation of noncompliant flocks may also be ob- the test being conducted, and inter- tained from this site, and either list viewing of personnel. may be obtained by writing to the Ani- (b) A laboratory may request ap- mal and Plant Health Inspection Serv- proval to conduct one or more types of ice, National Animal Health Programs scrapie test or genotype test on one or Staff, VS, APHIS, 4700 River Road Unit more types of tissue. To be approved, a 43, Riverdale, MD 20737–1235. laboratory must meet the requirements in paragraph (a) of this section (Approved by the Office of Management and for each type of test and for each type Budget under control number 0579–0101) of tissue for which they request approval. § 54.22 State scrapie certification (c) The Administrator may withdraw boards. approval of any laboratory for failure An area veterinarian in charge, after to meet any of the conditions required consulting with a State representative by paragraph (a) of this section. The and industry representatives, may ap- Administrator shall give written notice point a State scrapie certification of the proposed withdrawal to the di- board for the purpose of coordinating rector of the laboratory and shall give activities for the Scrapie Flock Certifi- the director an opportunity to respond. cation Program, including making de- If there are conflicts as to any material cisions to admit flocks to the Scrapie fact concerning the reason for with- Flock Certification Program and to drawal, a hearing will be held to re- change flock status in accordance with solve the conflicts. the Scrapie Flock Certification Pro- gram standards. These boards are not Subpart B—Scrapie Flock appointed for the purpose of providing Certification Program APHIS with consensus advice or policy recommendations. No more than one § 54.20 Administration. State scrapie certification board may The Scrapie Flock Certification Pro- be formed in each State. Each State gram is a cooperative effort between scrapie certification board shall in- APHIS; members of the sheep and goat clude as members the area veterinarian

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in charge, one or more State represent- Animal identification number (AIN). A atives, one or more accredited veteri- numbering system for the official iden- narians, when possible, and one or tification of individual animals in the more owners of flocks, and, at the dis- United States. The AIN contains 15 dig- cretion of the area veterinarian in its, with the first 3 being the country charge, may include other members. code (840 for the United States), the alpha characters USA, or the numeric PART 55—CONTROL OF CHRONIC code assigned to the manufacturer of WASTING DISEASE the identification device by the Inter- national Committee on Animal Record- ing. Sec. 55.1 Definitions. Animal and Plant Health Inspection Service (APHIS). The Animal and Plant Subpart A—Chronic Wasting Disease Health Inspection Service of the United Indemnification Program States Department of Agriculture. APHIS employee. Any individual em- 55.2 Payment of indemnity. ployed by the Animal and Plant Health 55.3 Appraisal and destruction of captive Inspection Service who is authorized cervids. by the Administrator to do any work 55.4 Disinfection of premises, conveyances, or perform any duty in connection with and materials. 55.5 Presentation of claims for indemnity. the control and eradication of disease. 55.6 Mortgage against animals. Approved State CWD Herd Certification 55.7 Claims not allowed. Program. A program operated by a 55.8 Official CWD tests and approval of lab- State government for certification of oratories to conduct official CWD tests. cervid herds with respect to CWD that the Administrator has determined to Subpart B—Chronic Wasting Disease Herd meet the requirements of § 55.23(a). Certification Program Cervid. All members of the family Cervidae and hybrids, including deer, 55.21 Administration. elk, moose, caribou, reindeer, and re- 55.22 Participation and enrollment. 55.23 Responsibilities of States and enrolled lated species. For the purposes of this herd owners. part, the term ‘‘cervid’’ refers specifi- 55.24 Herd status. cally to cervids susceptible to CWD. 55.25 Animal identification. These are animals in the genera Odocoileus, Cervus, and Alces and their AUTHORITY: 7 U.S.C. 8301–8317; 7 CFR 2.22, 2.80, and 371.4. hybrids, i.e., deer, elk, and moose. Commingled, commingling. Animals are SOURCE: 67 FR 5931, Feb. 8, 2002, unless oth- commingled if they have direct contact erwise noted. with each other, have less than 10 feet of physical separation, or share equip- § 55.1 Definitions. ment, pasture, or water sources/water- Accredited veterinarian. A veteri- shed. Animals are considered to have narian approved by the Administrator commingled if they have had such con- in accordance with part 161 of this tact with a positive animal or contami- chapter to perform functions specified nated premises within the last 5 years. in subchapters B, C, and D of this chap- CWD-exposed animal. An animal that ter. is part of a CWD-positive herd, or that Administrator. The Administrator, has been exposed to a CWD-positive Animal and Plant Health Inspection animal or contaminated premises with- Service, or any person authorized to in the previous 5 years. act for the Administrator. CWD-exposed herd. A herd in which a Animal. Any farmed or captive deer, CWD-positive animal has resided with- elk, or moose. in 5 years prior to that animal’s diag- Animal identification. A device or nosis as CWD-positive, as determined means of animal identification ap- by an APHIS employee or State rep- proved for use under this part by resentative. APHIS. Examples of animal identifica- CWD Herd Certification Program. The tion devices that APHIS has approved Chronic Wasting Disease Herd Certifi- are listed in § 55.25. cation Program established by this

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part. This program includes both herds Herd plan. A written herd and/or that are directly enrolled in the CWD premises management agreement de- Herd Certification Program and herds veloped by APHIS in collaboration that are included based on their par- with the herd owner, State representa- ticipation in Approved State CWD Herd tives, and other affected parties. The Certification Programs. herd plan will not be valid until it has CWD-positive animal. An animal that been reviewed and signed by the Ad- has had a diagnosis of CWD established ministrator, the State representative, through official confirmatory testing and the herd owner. A herd plan sets conducted by the National Veterinary out the steps to be taken to eradicate Services Laboratories. CWD from a CWD-positive herd, to con- CWD positive herd. A herd in which a trol the risk of CWD in a CWD-exposed CWD positive animal resided at the or CWD-suspect herd, or to prevent in- time it was diagnosed and which has troduction of CWD into that herd or not been released from quarantine. any other herd. A herd plan will re- CWD-source herd. A herd that is iden- quire specified means of identification tified through testing, tracebacks, and/ for each animal in the herd; regular ex- or epidemiological evaluations to be amination of animals in the herd by a the source of CWD-positive animals veterinarian for clinical signs of dis- identified in other herds. ease; reporting to a State or APHIS CWD-suspect animal. An animal for representative of any clinical signs of a which an APHIS employee or State central nervous system disease or representative has determined that un- chronic wasting condition in the herd; official CWD test results, laboratory maintaining records of the acquisition evidence or clinical signs suggest a di- and disposition of all animals entering agnosis of CWD, but for which official or leaving the herd, including the date laboratory results have been inconclu- of acquisition or removal, name and sive or not yet conducted. address of the person from whom the animal was acquired or to whom it was CWD-suspect herd. A herd for which disposed; and the cause of death, if the unofficial CWD test results, laboratory animal died while in the herd. A herd evidence, or clinical signs suggest a di- plan may also contain additional re- agnosis of CWD, as determined by an quirements to prevent or control the APHIS employee or State representa- possible spread of CWD, depending on tive, but for which official laboratory the particular circumstances of the results have been inconclusive or not herd and its premises, including but yet conducted. not limited to depopulation of the All animals in Deer, elk, and moose. herd, specifying the time for which a the genera Odocoileus, Cervus, and premises must not contain cervids Alces and their hybrids. after CWD-positive, -exposed, or -sus- Department. The United States De- pect animals are removed from the partment of Agriculture. premises; fencing requirements; selec- Farmed or captive. Privately or pub- tive culling of animals; restrictions on licly maintained or held for economic sharing and movement of possibly con- or other purposes within a perimeter taminated livestock equipment; prem- fence or confined area, or captured ises cleaning and disinfection require- from a free-ranging population for ments; or other requirements. A herd interstate movement and release. plan may be reviewed and changes to it Herd. One or more animals that are: suggested at any time by any party (1) Under common ownership or su- signatory to it, in response to changes pervision and are grouped on one or in the situation of the herd or premises more parts of any single premises (lot, or improvements in understanding of farm, or ranch) or the nature of CWD epidemiology or (2) All animals under common owner- techniques to prevent its spread. The ship or supervision on two or more revised herd plan will become effective premises which are geographically sep- after it is reviewed by the Adminis- arated but on which animals have been trator and signed by the Adminis- interchanged or had direct or indirect trator, the State representative, and contact with one another. the herd owner.

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Herd status. The status of a herd as- ber must both appear on the official signed under the CWD Herd Certifi- tag. cation Program in accordance with (4) Any other numbering system ap- § 55.24, indicating a herd’s relative risk proved by the Administrator for the for CWD. Herd status is based on the identification of animals in commerce. number of years of monitoring without Official appraiser (APHIS official ap- evidence of the disease and any specific praiser, State official appraiser). A per- determinations that the herd has con- son authorized by APHIS (an APHIS tained or has been exposed to a CWD- official appraiser) or a State (a State positive, -exposed or -suspect animal. official appraiser) to appraise animals Materials. Parts of barns or other for the purposes of this part. An offi- structures, straw, hay, and other feed cial appraiser may be an APHIS em- for animals, farm products or equip- ployee, a State employee, or a profes- ment, clothing, and any other articles sional livestock appraiser working on the premises that have been in con- under contract to APHIS or a State. tact with captive cervids. Official CWD test. Any test for the di- Mortgage. Any mortgage, lien, or agnosis of CWD approved by the Ad- other security or beneficial interest ministrator and conducted in a labora- held by any person other than the one tory approved by the Administrator in claiming indemnity. accordance with § 55.8 of this part. National Uniform Eartagging System. A Person. Any individual, corporation, numbering system for the official iden- company, association, firm, partner- tification of individual animals in the United States providing a nationally ship, society, joint stock company, or unique identification number for each other legal entity. animal. The National Uniform Premises identification number (PIN). A Eartagging System employs an eight- nationally unique number assigned by or nine-character alphanumeric for- a State, Tribal, and/or Federal animal mat, consisting of a two-number State health authority to a premises that is, or territory code, followed by two or in the judgment of the State, Tribal, three letters and four additional num- and/or Federal animal health author- bers. Official APHIS disease control ity, a geographically distinct location programs may specify which format to from other premises. The premises employ. identification number is associated Official animal identification. A device with an address, geospatial coordi- or means of animal identification ap- nates, and/or location descriptors proved for use under this part by which provide a verifiably unique loca- APHIS to uniquely identify individual tion. The premises identification num- animals. Examples of approved official ber may be used in conjunction with a animal identification devices are listed producer’s own livestock production in § 55.25. The official animal identifica- numbering system to provide a unique tion must include a nationally unique identification number for an animal. It animal identification number that ad- may also be used as a component of a heres to one of the following num- group/lot identification number. The bering systems: premises identification number may (1) National Uniform Eartagging Sys- consist of: tem. The CWD program allows the use (1) The State’s two-letter postal ab- of either the eight-character or nine- breviation followed by the premises’ character format for cervids. assigned number; or (2) Animal identification number (2) A seven-character alphanumeric (AIN). code, with the right-most character (3) Premises-based number system. being a check digit. The check digit The premises-based number system number is based upon the ISO 7064 Mod combines an official premises identi- 36/37 check digit algorithm. fication number (PIN), as defined in Secretary. The Secretary of Agri- this section, with a producer’s live- culture of the United States, or any of- stock production numbering system to ficer or employee of the Department provide a unique identification num- delegated to act in the Secretary’s ber. The PIN and the production num- stead.

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State. Each of the States of the mals, CWD exposed animals, and CWD United States, the District of Colum- suspect animals, and for State expendi- bia, Puerto Rico, the Northern Mariana tures for associated carcass disposal Islands, Guam, the Virgin Islands of and cleaning and disinfection costs re- the United States, or any other terri- sulting from such purchase and de- tory or possession of the United States. struction, in accordance with coopera- State representative. A person regu- tive agreements signed by the Adminis- larly employed in the animal health trator and the duly authorized agent of work of a State and who is authorized the State. by that State to perform the function involved. § 55.3 Appraisal and destruction of Trace back herd. A herd in which a captive cervids. CWD-positive animal formerly resided. (a) CWD positive herds, or individual Trace forward herd. A herd that has CWD suspect animals or exposed ani- received exposed animals from a CWD- positive herd within 5 years prior to mals removed by APHIS from a herd the diagnosis of CWD in the positive for testing, will be appraised by an herd or from the identified date of APHIS official appraiser and a State entry of CWD into the positive herd. official appraiser jointly, or, if APHIS Veterinarian in charge. The veterinary and State authorities agree, by either a official of Veterinary Services, APHIS, State official appraiser or an APHIS of- who is assigned by the Administrator ficial appraiser alone. to supervise and perform official ani- (b) The appraisal of cervids will be mal health work for APHIS in the the fair market value as determined by State concerned. the meat or breeding value of the animals. Animals may be appraised in [67 FR 5931, Feb. 8, 2002, as amended at 71 FR 41701, July 21, 2006; 77 FR 35565, June 13, 2012] groups, provided that where appraisal is by the head, each animal in the Subpart A—Chronic Wasting group is the same value per head, and Disease Indemnification Program where appraisal is by the pound, each animal in the group is the same value § 55.2 Payment of indemnity. per pound. (c) Appraisals of cervids must be re- The Administrator is authorized to ported on forms furnished by APHIS pay for the purchase and destruction of CWD positive animals, CWD exposed and signed by the appraisers, and animals, and CWD suspect animals. signed by the owner of the cervids to Subject to available funding, the indicate agreement with the appraisal amount of the Federal payment for any amount. Reports of appraisals must such animals will be 95 percent of the show the number of cervids and the appraised value established in accord- value per head or the weight and value ance with § 55.3 of this part, but the by pound. Federal payment shall not exceed $3,000 (d) In accordance with instructions per animal. If a non-Federal source from an APHIS employee, cervids for makes a payment for an animal for which indemnification is sought must which a Federal indemnity is paid, and be: the non-Federal payment exceeds 5 per- (1) Destroyed on the premises where cent of the appraised value established they are held, pastured, or penned at in accordance with § 55.3 of this part, the time indemnity is approved; the amount of the Federal payment for (2) Moved to another location for de- any such animals will be reduced by struction under conditions specified by the amount by which the non-Federal the APHIS employee; or payment exceeds 5 percent of the ap- (3) Moved to an approved research fa- praised value. The Administrator is also authorized to reimburse State gov- cility under conditions specified by the ernments or State animal health agen- APHIS employee. cies for payments they make for the (e) The carcasses of any cervids de- purchase and destruction, on or after stroyed in accordance with this part October 1, 2001, of CWD positive ani- are authorized by the Administrator to

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be incinerated, destroyed in an alka- infecting premises when the procedures line hydrolysis tissue digestor, or dis- needed to conduct effective cleaning posed of by any other method author- and disinfection are unusually exten- ized by an APHIS employee and in ac- sive and require methods that are not cordance with local, State, and Federal normally available on a premises. For laws. APHIS will pay the reasonable example, normal procedures would in- costs of destruction and carcass dis- clude washing surfaces with high-pres- posal for animals that are indemnified. sure hoses and disinfectants and bury- To obtain reimbursement for disposal ing or burning contaminated materials. costs, animal owners must obtain writ- Unusually extensive procedures would ten approval of the disposal costs from include disposing of contaminated ma- APHIS, prior to disposal. Except in terials by digestive disposal or high- cases where APHIS or a State directly temperature incineration. arranges for disposal, the owner of the animals must present an APHIS em- § 55.5 Presentation of claims for in- ployee with a written contract or esti- demnity. mate of disposal costs. Prior to receiv- Claims for indemnity for the value of ing reimbursement, the owner must animals destroyed must be documented also present an APHIS employee with a on a form furnished by APHIS and pre- copy of either a receipt for expenses sented to an APHIS employee or a paid by the owner or a bill for services State representative authorized to ac- rendered to the owner. Any bill for cept the claims. services rendered presented by the owner must not be greater than the (Approved by the Office of Management and normal fee for similar services pro- Budget under control number 0579–0189) vided by commercial entities. The car- § 55.6 Mortgage against animals. casses of cervids destroyed in accordance with this section may not be sold When cervids have been destroyed to be processed for human or animal under this part, any claim for indem- food, including dietary supplements. nity must be presented on forms furnished by APHIS. The owner of the (Approved by the Office of Management and cervids must certify on the forms that Budget under control number 0579–0189) the cervids covered are, or are not, sub- § 55.4 Disinfection of premises, convey- ject to any mortgage as defined in this ances, and materials. part. If the owner states there is a mortgage, the owner and each person After cervids are destroyed in accord- holding a mortgage on the cervids ance with this part, all premises, in- must sign, consenting to the payment cluding barns, stockyards and pens, all of indemnity to the person specified on cars and other conveyances, and all the form. other materials on any premises or conveyances used to house or transport (Approved by the Office of Management and such cervids must be cleaned and dis- Budget under control number 0579–0189) infected under the supervision of an APHIS employee or a State representa- § 55.7 Claims not allowed. tive, using methods specified by the (a) The Department will not allow APHIS employee or a State representa- claims arising out of the destruction of tive. Premises may not be restocked cervids unless the cervids have been ap- with cervids until after the date speci- praised as prescribed in this part and fied in the herd plan required by the owners have signed the appraisal § 55.7(b) of this part. The owner to form indicating agreement with the ap- whom the indemnity is paid will be re- praisal amount as required by § 55.3(c) sponsible for expenses incurred in con- of this part. nection with the cleaning and disinfec- (b) The Department will not allow tion, except that APHIS or a State will claims arising out of the destruction of pay for cleaning and disinfection of the cervids unless the owners have signed a conveyances used to transport the written agreement with APHIS in cervids to the location of disposal. which they agree that if they maintain However, APHIS may also decide to cervids in the future on the premises pay the cost of cleaning and dis- used for cervids for which indemnity is

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paid, they will maintain the cervids in (3) Data to support suitability, that accordance with a herd plan and will is, data to show that similar results not introduce cervids onto the prem- can be produced when the test is run at ises until after the date specified in other laboratories; that herd plan. Persons who violate (4) Data to support the sensitivity this written agreement may be subject and specificity of the test; and to civil and criminal penalties. (5) Any other data requested by the (c) The Department will not allow Administrator to determine the suit- claims arising out of the destruction of ability of the test for program use. cervids that have been moved or han- (c) Specific protocols for official CWD dled by the owner or a representative tests are available upon request to of the owner in violation of a law or NVSL. regulation administered by the Sec- (d) State, Federal, and university retary regarding animal disease, or in laboratories will be approved by the violation of a law or regulation for Administrator to conduct official CWD which the Secretary has entered into a tests when he or she determines that cooperative agreement. the laboratory: (1) Employs personnel assigned to su- (Approved by the Office of Management and pervise the testing who are qualified to Budget under control number 0579–0189) conduct the test based on education, training, and experience and who have § 55.8 Official CWD tests and approval been trained by NVSL or who have of laboratories to conduct official completed equivalent training ap- CWD tests. proved by NVSL; (a) An official CWD test is: (2) Has adequate facilities and equip- (1) Histopathological examination of ment to conduct the test; central nervous system (CNS) tissues (3) Follows standard test protocols; from the animal for characteristic mi- (4) Meets check test proficiency re- croscopic lesions of CWD, using test quirements; protocols provided by the National (5) Meets recordkeeping require- Veterinary Services Laboratories ments; (NVSL); (6) Will retain records, slides, blocks, (2) The use of proteinase-resistant and other specimens from all cases for protein analysis methods including but at least 1 year and from positive cases not limited to immunohistochemistry for 5 years; and/or western blotting on CNS and/or (7) Will allow APHIS to inspect 1 the peripheral tissue samples from a live or laboratory without notice during nor- a dead animal, using test protocols pro- mal business hours; and vided by NVSL; or (8) Will report all test results to (3) Any other test method approved State and Federal animal health offi- by the Administrator in accordance cials within agreed timeframes. with this section. (e) The Administrator may withdraw approval of any laboratory for failure (b) The Administrator may approve to meet any of the conditions required new tests for the diagnosis of CWD con- by paragraph (d) of this section. The ducted on live or dead animals, and Administrator shall give written notice will base the approval or disapproval of of the proposed withdrawal to the di- a test on the evaluation by APHIS and, rector of the laboratory and shall give when appropriate, outside scientists, the director an opportunity to respond. of: If there are conflicts as to any material (1) A standardized test protocol that fact concerning the reason for with- must include a description of the test, drawal, a hearing will be held to re- a description of the reagents, mate- solve the conflicts. The hearing will be rials, and equipment used for the test, conducted in accordance with rules of the test methodology, and any control or quality assurance procedures; 1 An inspection may include, but is not lim- (2) Data to support reproducibility, ited to, review and copying of records, exam- that is, the ability to reproduce the ination of slides, observation of the test same result repeatedly on a given sam- being conducted, and interviewing of per- ple; sonnel.

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practice that will be adopted by the and if needed will require the owner to Administrator for the proceeding. submit more details about the herd animals and operations. An application Subpart B—Chronic Wasting Dis- for participation may be denied if ease Herd Certification Pro- APHIS or the State determines that gram the applicant has previously violated State or Federal laws or regulations for livestock, and that the nature of SOURCE: 77 FR 35566, June 13, 2012, unless the violation indicates that the appli- otherwise noted. cant may not faithfully comply with the requirements of the CWD Herd Cer- § 55.21 Administration. tification Program. If the enrolling The CWD Herd Certification Program herd is a CWD-positive herd or CWD- is a cooperative effort between APHIS, exposed herd, immediately after enroll- State animal health and wildlife agen- ment it must begin complying with a cies, and deer, elk, and moose owners. herd plan developed in accordance with APHIS coordinates with these State § 55.24. After determining that the herd agencies to encourage deer, elk, and is eligible to participate in accordance moose owners to certify their herds as with this paragraph, APHIS or the ap- low risk for CWD by being in contin- propriate State agency will send the uous compliance with the CWD Herd herd owner a notice of enrollment that Certification Program standards. includes the herd’s enrollment date. In- quiries regarding which herds are par- § 55.22 Participation and enrollment. ticipating in the CWD Herd Certifi- (a) Participation by States. Any State cation Program and their certification that operates a State program to cer- should be directed to the State rep- tify the CWD status of deer, elk, or resentative of the relevant State. moose may request the Administrator (1) Enrollment date. With the excep- to designate the State program as an tions listed in this paragraph, the en- Approved State CWD Herd Certifi- rollment date for any herd that joins cation Program. The Administrator the CWD Herd Certification Program will approve or disapprove a State pro- after August 13, 2012 will be the date gram in accordance with § 55.23(a). In the herd is approved for participation. States with an Approved State CWD (i) For herds already participating in Herd Certification Program, program State CWD programs, the enrollment activities will be conducted in accord- date will be the first day that the herd ance with the guidelines of that pro- participated in a State program that gram as long as the State program APHIS subsequently determines quali- meets the minimum requirements of fies as an Approved State CWD Herd this part. A list of Approved State Certification Program in accordance CWD Herd Certification Programs may with § 55.23(a) of this part. be obtained by writing to the National (ii) For herds that enroll directly in Center for Animal Health Program, the Federal CWD Herd Certification VS, APHIS, 4700 River Road Unit 43, Program, which is allowed only when Riverdale, MD 20737–1235. there is no Approved State CWD Herd (b) Participation by owners. Any owner Certification Program in their State of a farmed or captive deer, elk, or and which is subject to the availability moose herd may apply to enroll in an of appropriated funds, the enrollment Approved State CWD Herd Certifi- date will be the earlier of: cation Program by sending a written (A) The date APHIS approves enroll- request to the appropriate State agen- ment; or cy. Subject to the availability of ap- (B) If APHIS determines that the propriated funds for a Federal CWD herd owner has maintained the herd in Herd Certification Program, the owner a manner that substantially meets the may apply to the APHIS veterinarian conditions specified in § 55.23(b) for in charge if no Approved State CWD herd owners, the first day that the herd Herd Certification Program exists in participated in such a program. How- the herd’s State. APHIS or the State ever, in such cases the enrollment date will determine the herd’s eligibility, may not be set at a date more than 3

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years prior to the date that APHIS ap- (ii) Designate herds as CWD-positive, proved enrollment of the herd. CWD-exposed, or CWD-suspect and (iii) For new herds that were formed promptly restrict movement of ani- from and contain only animals from mals from the herd after an APHIS em- herds enrolled in the CWD Herd Certifi- ployee or State representative deter- cation Program, the enrollment date mines that the herd contains or has will be the latest enrollment date for contained a CWD-positive animal; any source herd for the animals. (iii) Remove herd movement restric- (2) [Reserved] tions only after completion of a herd plan agreed upon by the State rep- (Approved by the Office of Management and resentative, APHIS, and the owner; Budget under control number 0579–0237) (iv) Conduct an epidemiologic inves- § 55.23 Responsibilities of States and tigation of CWD-positive, CWD-ex- enrolled herd owners. posed, and CWD-suspect herds that includes the designation of suspect and (a) Approval of State programs and re- exposed animals and that identifies sponsibilities of States. In reviewing a animals to be traced; State program’s eligibility to be des- (v) Conduct tracebacks of CWD-posi- ignated an Approved State CWD Herd tive animals and traceouts of CWD-ex- Certification Program, the Adminis- posed animals and report any out-of- trator will evaluate a written state- State traces to the appropriate State ment from the State that describes the promptly after receipt of notification State’s CWD control and deer, elk, and of a CWD-positive animal; and moose herd certification activities and (vi) Conduct tracebacks based on that cites relevant State statutes, reg- slaughter or other sampling promptly ulations, and directives pertaining to after receipt of notification of a CWD- animal health activities and reports positive animal at slaughter. and publications of the State. In deter- (6) Effectively monitors and enforces mining whether the State program State quarantines and State reporting qualifies, the Administrator will deter- laws and regulations for CWD. mine whether the State: (7) Has designated at least one State (1) Has the authority, based on State animal health official, or has worked law or regulation, to restrict the intra- with APHIS to designate an APHIS of- state movement of all CWD-positive, ficial, to coordinate CWD Herd Certifi- CWD-suspect, and CWD-exposed ani- cation Program activities in the State. mals. (8) Has programs to educate those en- (2) Has the authority, based on State gaged in the interstate movement of law or regulation, to require the deer, elk, and moose regarding the prompt reporting of any animal sus- identification and recordkeeping re- pected of having CWD and test results quirements of this part. for any animals tested for CWD to (9) Requires, based on State law or State or Federal animal health au- regulation, and effectively enforces thorities. identification of all animals in herds (3) Has, in cooperation with APHIS participating in the CWD Herd Certifi- personnel, drafted and signed a memo- cation Program; randum of understanding with APHIS (10) Maintains in the CWD National that delineates the respective roles of Database administered by APHIS, or in the State and APHIS in CWD Herd Cer- a State database approved by the Ad- tification Program implementation. ministrator as compatible with the (4) Has placed all known CWD-posi- CWD National Database, the State’s: tive, CWD-exposed, and CWD-suspect (i) Premises information and as- animals and herds under movement re- signed premises numbers; strictions, with movement of animals (ii) Individual animal information on from them only for destruction or all deer, elk, and moose in herds par- under permit. ticipating in the CWD Herd Certifi- (5) Has effectively implemented poli- cation Program in the State; cies to: (iii) Individual animal information (i) Promptly investigate all animals on all out-of-State deer, elk, and moose reported as CWD-suspect animals; to be traced; and

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(iv) Accurate herd status data. or State representative and must make (11) Requires that tissues from all the carcasses of the animals available CWD-exposed or CWD-suspect animals for tissue sampling and testing in ac- that die or are depopulated or other- cordance with instructions from the wise killed be submitted to a labora- APHIS or State representative. In tory authorized by the Administrator cases where animals escape or dis- to conduct official CWD tests and re- appear and thus are not available for quires appropriate disposal of the car- tissue sampling and testing, or when casses of CWD-positive, CWD-exposed, the owner provides samples that are of and CWD-suspect animals. such poor quality that they cannot be (b) Responsibilities of enrolled herd tested for CWD, an APHIS representa- owners. Herd owners who enroll in the tive will investigate whether the un- CWD Herd Certification Program agree availability of animals or usable sam- to maintain their herds in accordance ples for testing constitutes a failure to with the following conditions: comply with program requirements and (1) Each animal in the herd must be will affect the herd’s status in the CWD identified using means of animal iden- Herd Certification Program; tification specified in § 55.25. All ani- (4) The owner must maintain herd mals in an enrolled herd must be iden- records that include a complete inven- tified before reaching 12 months of age. tory of animals that states the species, In addition, all animals of any age in age, and sex of each animal, the date of an enrolled herd must be identified be- acquisition and source of each animal fore being moved from the herd prem- that was not born into the herd, the ises. In addition, all animals in an enrolled herd must be identified before date of disposal and destination of any the inventory required under para- animal removed from the herd, and all graph (b)(4) of this section, and animals individual identification numbers found to be in violation of this require- (from tags, tattoos, electronic im- ment during the inventory must be plants, etc.) associated with each ani- identified during or after the inventory mal. Upon request by an APHIS em- on a schedule specified by the APHIS ployee or State representative, the employee or State representative con- owner must allow either of these offi- ducting the inventory; cials or a designated accredited veteri- (2) The herd premises must have pe- narian access to the premises and herd rimeter fencing adequate to prevent in- to conduct an inventory. The owner gress or egress of cervids. This fencing will be responsible for assembling, han- must also comply with any applicable dling, and restraining the animals and State regulations; for all costs incurred to present the (3) The owner must immediately re- animals for inspection. The APHIS em- port to an APHIS employee or State ployee or State representative may representative all animals that escape order either an inventory that consists or disappear, and all deaths (including of review of herd records with visual animals killed on premises maintained examination of an enclosed group of for hunting and animals sent to slaugh- animals, or a complete physical herd ter) of deer, elk, and moose in the herd inventory with verification to rec- aged 12 months or older; Except that, oncile all animals and identifications APHIS employees or State representa- with the records maintained by the tives may approve reporting schedules owner. In the latter case, the owner other than immediate notification must present the entire herd for in- when herd conditions warrant it in the spection under conditions where the opinion of both APHIS and the State. APHIS employee, State representative, The report must include the identifica- or accredited veterinarian can safely tion numbers of the animals involved read all identification on the animals. and the estimated time and date of the During inventories, the owner must co- death, escape, or disappearance. For operate with the inspector to resolve animals that die (including animals any discrepancies to the satisfaction of killed on premises maintained for the person performing the inventory. hunting and animals sent to slaugh- Inventory of a herd will be conducted ter), the owner must inform an APHIS no more frequently than once per year,

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unless an APHIS employee, State rep- will have the same status as the lowest resentative, or accredited veterinarian status of any herd that provided ani- determines that more frequent inven- mals for the new herd. If the herd con- tories are needed based on indications tinues to meet the requirements of the that the herd may not be in compliance CWD Herd Certification Program, each with CWD Herd Certification Program year, on the anniversary of the enroll- requirements. A complete physical ment date the herd status will be up- herd inventory must be performed on a graded by 1 year; i.e., Second Year sta- herd in accordance with this paragraph tus, Third Year status, Fourth Year at the time a herd is enrolled in the status, and Fifth Year status. One year CWD Herd Certification Program; Ex- from the date a herd is placed in Fifth cept that, APHIS may accept a com- Year status, the herd status will be plete physical herd inventory per- changed to Certified, and the herd will formed by an APHIS employee, State remain in Certified status as long as it representative, or accredited veteri- is enrolled in the program, provided its narian not more than 1 year before the status is not lost or suspended in ac- herd’s date of enrollment in the CWD cordance with this section. Herd Certification Program as ful- (b) Loss or suspension of herd status. filling the requirement for an initial (1) If a herd is designated a CWD-posi- inventory. In addition, a complete tive herd or a CWD-exposed herd, it physical herd inventory must be per- will immediately lose its program sta- formed for all herds enrolled in the tus and may only reenroll after enter- CWD Herd Certification Program no ing into a herd plan. more than 3 years after the last com- (2) If a herd is designated a CWD-sus- plete physical herd inventory for the pect herd, a trace back herd, or a trace herd; forward herd, it will immediately be (5) If an owner wishes to maintain placed in Suspended status pending an separate herds, he or she must main- epidemiologic investigation by APHIS tain separate herd inventories, records, or a State animal health agency. If the working facilities, water sources, epidemiologic investigation determines equipment, and land use. There must that the herd was not commingled with be a buffer zone of at least 30 feet be- a CWD-positive animal, the herd will tween the perimeter fencing around be reinstated to its former program separate herds, and no commingling of status, and the time spent in Sus- animals may occur. Movement of ani- pended status will count toward its mals between herds must be recorded promotion to the next herd status as if they were separately owned herds; level. (6) New animals may be introduced (i) If the epidemiologic investigation into the herd only from other herds en- determines that the herd was commin- rolled in the CWD Herd Certification gled with a CWD-positive animal, the Program. If animals are received from herd will lose its program status and an enrolled herd with a lower program will be designated a CWD-exposed herd. status, the receiving herd will revert to (ii) If the epidemiological investiga- that lower program status. If animals tion is unable to make a determination are obtained from a herd not partici- regarding the exposure of the herd, be- pating in the program, then the receiv- cause the necessary animal or animals ing herd will be required to start over are no longer available for testing (i.e., in the program. a trace animal from a known positive (Approved by the Office of Management and herd died and was not tested) or for Budget under control number 0579–0237) other reasons, the herd status will continue as Suspended unless and until a § 55.24 Herd status. herd plan is developed for the herd. If a (a) Initial and subsequent status. When herd plan is developed and imple- a herd is first enrolled in the CWD Herd mented, the herd will be reinstated to Certification Program, it will be placed its former program status, and the in First Year status; except that, if the time spent in Suspended status will herd is composed solely of animals ob- count toward its promotion to the next tained from herds already enrolled in herd status level; Except that, if the epi- the Program, the newly enrolled herd demiological investigation finds that

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the owner of the herd has not fully upon which the herd owner relies to complied with program requirements show that the reasons for the action for animal identification, animal test- are incorrect or do not support the ac- ing, and recordkeeping, the herd will be tion. Specifically, to appeal designa- reinstated into the CWD Herd Certifi- tion of an animal as CWD-positive, the cation Program at the First Year sta- owner may present as evidence the re- tus level, with a new enrollment date sults of a DNA test requested and paid set at the date the herd entered into for by the owner to determine whether Suspended status. Any herd reinstated previous official CWD test results were after being placed in Suspended status correctly associated with an animal must then comply with the require- that belonged to the owner. If the ments of the herd plan as well as the owner intends to present such test re- requirements of the CWD Herd Certifi- sults as evidence, he or she shall re- cation Program. The herd plan will request the tests and state this in the quire testing of all animals that die in written notice sent to the Adminis- the herd for any reason, regardless of trator. In such cases the Administrator the age of the animal, may require may postpone a decision on the appeal movement restrictions for animals in for a reasonable period pending receipt the herd based on epidemiologic evi- of such test results. To this end, lab- dence regarding the risk posed by the oratories approved under § 55.8 are au- animals in question, and may include thorized to conduct DNA tests to com- other requirements found necessary to pare tissue samples tested for CWD to control the risk of spreading CWD. samples from tissues that were col- (3) If an APHIS or State representa- lected at the same time from the same tive determines that animals from a animal and are attached to an official herd enrolled in the program have com- identification device. Such DNA tests mingled with animals from a herd with are available only if the animal owner a lower program status, the herd with arranged to submit animal tissue at- the higher program status will be re- tached to an official identification de- duced to the status of the herd with vice along with the other tissues that which its animals commingled. were collected for the official CWD (c) Cancellation of enrollment by Ad- test. The Administrator will grant or ministrator. The Administrator may deny the appeal in writing as promptly cancel the enrollment of an enrolled as circumstances permit, stating the herd by giving written notice to the reason for his or her decision. If the herd owner. In the event of such can- Administrator grants an appeal of the cellation, any herd enrolled in the CWD status of a CWD-positive animal, the Herd Certification Program by that animal shall be redesignated as CWD- herd owner may not reach Certified suspect pending further investigation status until 5 years after the herd own- to establish the final status of the ani- er’s new application for enrollment is mal and its herd. If there is a conflict approved by APHIS, regardless of the as to any material fact, a hearing will status of the animals of which the herd be held to resolve the conflict. Rules of is composed. The Administrator may practice concerning the hearing will be cancel enrollment after determining adopted by the Administrator. that the herd owner failed to comply (2) [Reserved] with any requirements of this subpart. (d) Herd status of animals added to Before enrollment is canceled, an herds. A herd may add animals from APHIS representative will inform the herds with the same or a higher herd herd owner of the reasons for the pro- status in the CWD Herd Certification posed cancellation. Program with no negative impact on (1) Herd owners may appeal designa- the certification status of the receiving tion of an animal as CWD-positive, can- herd.5 If animals are acquired from a cellation of enrollment of a herd, or loss or suspension of herd status by 5 Note that in addition to this requirement, writing to the Administrator within 10 § 81.3 of this chapter restricts the interstate days after being informed of the rea- movement of farmed and captive deer, elk, sons for the action. The appeal must and moose based on their status in the CWD include all of the facts and reasons Herd Certification Program.

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herd with a lower herd status, the re- § 56.1 Definitions. ceiving herd reverts to the program Administrator. The Administrator, status of the sending herd. If a herd Animal and Plant Health Inspection participating in the CWD Herd Certifi- Service, or any other employee of the cation Program acquires animals from Animal and Plant Health Inspection a nonparticipating herd, the receiving Service delegated to act in the Admin- herd reverts to First Year status with istrator’s stead. a new enrollment date of the date of Animal and Plant Health Inspection acquisition of the animal. Service (APHIS). The Animal and Plant (Approved by the Office of Management and Health Inspection Service of the U.S. Budget under control number 0579–0237.) Department of Agriculture. Breeding flock. A flock that is com- § 55.25 Animal identification. posed of stock that has been developed Each animal required to be identified for commercial egg or meat production by this subpart must have at least two and is maintained for the principal pur- forms of animal identification attached pose of producing chicks for the ulti- to the animal. One of the animal iden- mate production of eggs or meat for tifications must be official animal human consumption. identification as defined in this part, Classification. A designation earned with a nationally unique animal identi- by participation in a Plan program. fication number that is linked to that Commercial flock or slaughter plant. A animal in the CWD National Database commercial poultry flock or slaughter or in an approved State database. The plant that is required because of its second animal identification must be size to participate in the special provi- unique for the individual animal within sions in part 146 of this chapter in the herd and also must be linked to order to participate in the Plan. that animal and herd in the CWD Na- Cooperating State Agency. Any State tional Database or in an approved authority recognized by the Depart- State database. The means of animal ment to cooperate in the administra- identification must be approved for tion of the provisions of this part 56. this use by APHIS, and must be an This may include the State animal electronic implant, flank tattoo, ear health authority or the Official State tattoo, tamper-resistant ear tag, or Agency. other device approved by APHIS. Department. The U.S. Department of Agriculture. (Approved by the Office of Management and Domesticated. Propagated and main- Budget under control number 0579–0237) tained under the control of a person. Flock plan. A written flock manage- PART 56—CONTROL OF H5/H7 ment agreement developed by APHIS LOW PATHOGENIC AVIAN INFLU- and the Official State Agency with ENZA input from the flock owner and other affected parties. A flock plan sets out Sec. the steps to be taken to eradicate H5/ 56.1 Definitions. H7 LPAI from a positive flock, or to 56.2 Cooperation with States. prevent introduction of H5/H7 LPAI 56.3 Payment of indemnity. into another flock. A flock plan shall 56.4 Determination of indemnity amounts. include, but is not necessarily limited 56.5 Destruction and disposal of poultry and cleaning and disinfection of premises, to, poultry and poultry product move- conveyances, and materials. ment and geographically appropriate 56.6 Presentation of claims for indemnity. infected and control/monitoring zones. 56.7 Mortgage against poultry or eggs. Control measures in the flock plan 56.8 Conditions for payment. should include detailed plans for safe 56.9 Claims not allowed. handling of conveyances, containers, 56.10 Initial State response and contain- and other associated materials that ment plan. could serve as fomites; disposal of AUTHORITY: 7 U.S.C. 8301–8317; 7 CFR 2.22, flocks; cleaning and disinfection; down- 2.80, and 371.4. time; and repopulation. SOURCE: 71 FR 56323, Sept. 26, 2006, unless H5/H7 low pathogenic avian influenza otherwise noted. (LPAI). An infection of poultry caused

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by an influenza A virus of H5 or H7 Official appraiser (APHIS official ap- subtype that has an intravenous patho- praiser, State official appraiser). A per- genicity index test in 6-week-old chick- son authorized by APHIS to appraise ens less than 1.2 or any infection with poultry for the purposes of this part. A influenza A viruses of H5 or H7 subtype State official appraiser is selected by a for which nucleotide sequencing has State and authorized by APHIS. not demonstrated the presence of mul- Official State Agency. The State au- tiple basic amino acids at the cleavage thority recognized by the Department site of the hemagglutinin. to cooperate in the administration of H5/H7 LPAI exposed. At risk of devel- the Plan. oping H5/H7 LPAI because of associa- Plan. The provisions of the National tion with birds or poultry infected with Poultry Improvement Plan contained H5/H7 LPAI, excrement from birds or in parts 145, 146, and 147 of this chapter. poultry infected with H5/H7 LPAI, or Poultry. Domesticated fowl, including other material touched by birds or chickens, turkeys, ostriches, emus, poultry infected with H5/H7 LPAI, or rheas, cassowaries, waterfowl, and because there is reason to believe that game birds, except doves and pigeons, association has occurred with H5/H7 which are bred for the primary purpose LPAI or vectors of H5/H7 LPAI, as de- of producing eggs or meat. termined by the Cooperating State Secretary. The Secretary of the Agency and confirmed by APHIS. United States Department of Agri- H5/H7 LPAI virus infection (infected). culture, or any officer or employee of (1) Poultry will be considered to be in- the Department delegated to act in the fected with H5/H7 LPAI for the pur- Secretary’s stead. poses of this part if: State. Any of the States, the District (i) H5/H7 LPAI virus has been iso- of Columbia, the Commonwealth of lated and identified as such from poul- Puerto Rico, Guam, the Common- try; or wealth of the Northern Mariana Is- (ii) Viral antigen or viral RNA spe- lands, the Virgin Islands of the United cific to the H5 or H7 subtype of AI virus States, or any territory or possession has been detected in poultry; or of the United States. (iii) Antibodies to the H5 or H7 Table-egg layer. A domesticated subtype of the AI virus that are not a chicken grown for the primary purpose consequence of vaccination have been of producing eggs for human consump- detected in poultry. If vaccine is used, tion. methods should be used to distinguish United States. All of the States. vaccinated birds from birds that are both vaccinated and infected. In the [71 FR 56323, Sept. 26, 2006, as amended at 75 case of isolated serological positive re- FR 10656, Mar. 9, 2010; 76 FR 15792, Mar. 22, sults, H5/H7 LPAI infection may be 2011] ruled out on the basis of a thorough ep- § 56.2 Cooperation with States. idemiological investigation that does not demonstrate further evidence of (a) The Administrator has been dele- H5/H7 LPAI infection, as determined by gated the authority to cooperate with APHIS. Cooperating State Agencies in the (2) The official determination that eradication of H5/H7 LPAI. This co- H5/H7 LPAI virus has been isolated and operation may include, but is not nec- identified, viral antigen or viral RNA essarily limited to, the following ac- specific to the H5 or H7 subtype of AI tivities: virus has been detected, or antibodies (1) Payment to Cooperating State to the H5 or H7 subtype of AI virus Agencies for surveillance and moni- have been detected may only be made toring associated with poultry that by the National Veterinary Services have been infected with or exposed to Laboratories. H5/H7 LPAI; Mortgage. Any mortgage, lien, or (2) Transfer of vaccine for H5/H7 other security or beneficial interest LPAI to Cooperating State Agencies if held by any person other than the one provided for in the initial State re- claiming indemnity for the destruction sponse and containment plan approved of poultry or eggs due to H5/H7 LPAI. by APHIS under § 56.10; and

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(3) Payment for vaccine administra- provided in paragraph (b) of this section by Cooperating State Agencies, if tion: provided for in the initial State re- (1) Destruction and disposal of poul- sponse and containment plan approved try that were infected with or exposed by APHIS under § 56.10. to H5/H7 LPAI; (b)(1) Any payment made to a State (2) Destruction of any eggs destroyed or an Official State Agency for the ac- during testing of poultry for H5/H7 tivities listed in paragraphs (a)(1) and LPAI during an outbreak of H5/H7 (a)(3) of this section must be made LPAI; and through a cooperative agreement be- (3) Cleaning and disinfection of prem- tween the Cooperating State Agency ises, conveyances, and materials that and APHIS. The payment for which the came into contact with poultry that Cooperating State Agency is eligible were infected with or exposed to H5/H7 will be determined in the cooperative LPAI; or, in the case of materials, if agreement. the cost of cleaning and disinfection (i) For any Cooperating State Agency would exceed the value of the mate- that participates in the National Poul- rials or cleaning and disinfection would try Improvement Plan diagnostic sur- be impracticable for any reason, the veillance program for H5/H7 LPAI, as destruction and disposal of the mate- described in § 146.14 of this chapter, and rials. has an initial State response and con- (b) Percentage of costs eligible for in- tainment plan for H5/H7 LPAI that is demnity. Except for poultry that are de- approved by APHIS, as described in scribed by the categories in paragraphs § 56.10 of this part, the cooperative (b)(1) through (b)(3) of this section, the agreement will provide that the Co- Administrator is authorized to pay 100 operating State Agency is eligible for percent of the costs, as determined in payment of 100 percent of the costs of accordance with § 56.4, of the activities surveillance and monitoring and 100 described in paragraphs (a)(1) through percent of the costs of vaccine adminis- (a)(3) of this section, regardless of tration, as determined in the coopera- whether the infected or exposed poul- tive agreement. try participate in the Plan. For in- (ii) For any Cooperating State Agen- fected or exposed poultry that are de- cy that does not meet the criteria in scribed by the categories in paragraphs paragraph (b)(1)(i) of this section, the (b)(1) through (b)(3) of this section, the cooperative agreement will provide Administrator is authorized to pay 25 that the Cooperating State Agency is percent of the costs of the activities eligible for payment of 25 percent of described in paragraphs (a)(1) through the costs of surveillance and moni- (a)(3) of this section: toring and 25 percent of the costs of (1) The poultry are from a breeding vaccine administration, as determined flock that participates in any Plan pro- in the cooperative agreement. gram in part 145 of this chapter but (2) Transfer of vaccine under para- that does not participate in the U.S. graph (a)(2) of this section must be ac- Avian Influenza Clean or the U.S. H5/ complished through a cooperative H7 Avian Influenza Clean program of agreement between the Cooperating the Plan available to the flock in part State Agency and APHIS. 145 of this chapter; or (c) Cooperating State Agencies will (2) The poultry are from a commer- be responsible for making the deter- cial flock or slaughter plant, but the mination to request Federal assistance flock or slaughter plant does not par- under this part in the event of an out- ticipate in the U.S. Avian Influenza break of H5/H7 LPAI. Monitored program available to the [71 FR 56323, Sept. 26, 2006, as amended at 75 commercial flock or slaughter plant in FR 10656, Mar. 9, 2010] part 146 of this chapter; or (3) The poultry are located in a State § 56.3 Payment of indemnity. that does not participate in the diag- (a) Activities eligible for indemnity. The nostic surveillance program for H5/H7 Administrator may pay indemnity for LPAI, as described in § 146.14 of this the activities listed in paragraphs chapter, or that does not have an ini- (a)(1) through (a)(3) of this section, as tial State response and containment

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plan for H5/H7 LPAI that is approved mentation maintained by the claimant by APHIS under § 56.10, unless such verifying expenditures for disposal ac- poultry participate in the Plan with tivities authorized by this part. Any another State that does participate in disposal of poultry infected with or ex- the diagnostic surveillance program for posed to H5/H7 LPAI for which indem- H5/H7 LPAI, as described in § 146.14 of nity is requested must be performed this chapter, and has an initial State under a compliance agreement between response and containment plan for H5/ the claimant, the Cooperating State H7 LPAI that is approved by APHIS Agency, and APHIS. APHIS will review under § 56.10. claims for indemnity for disposal to en- (c) Other sources of payment. If the re- sure that all expenditures relate di- cipient of indemnity for any of the ac- rectly to activities described in § 56.5 tivities listed in paragraphs (a)(1) and in the initial State response and through (a)(3) of this section also re- containment plan described in § 56.10. If ceives payment for any of those activi- disposal is performed by the Cooper- ties from a State or from other ating State Agency, APHIS will indem- sources, the indemnity provided under nify the Cooperating State Agency for this part will be reduced by the total disposal under a cooperative agree- amount of payment received from the ment. State or other sources. (3) The destruction and disposal of [71 FR 56323, Sept. 26, 2006, as amended at 75 the indemnified poultry must be con- FR 10657, Mar. 9, 2010; 76 FR 15792, Mar. 22, ducted in accordance with the initial 2011; 76 FR 65935, Oct. 25, 2011] State response and containment plan for H5/H7 LPAI, as described in § 56.10. § 56.4 Determination of indemnity (b) Destruction of eggs. Indemnity for amounts. eggs destroyed during an outbreak for (a) Destruction and disposal of poultry. testing for H5/H7 LPAI will be based on (1) Indemnity for the destruction of the fair market value of the eggs, as poultry infected with or exposed to H5/ determined by an appraisal. Eggs de- H7 LPAI will be based on the fair mar- stroyed for testing for H5/H7 LPAI will ket value of the poultry, as determined be appraised by an APHIS official ap- by an appraisal. Poultry infected with praiser and a State official appraiser or exposed to H5/H7 LPAI that are re- jointly, or, if APHIS and State authori- moved by APHIS or a Cooperating ties agree, by either an APHIS official State Agency from a flock will be ap- appraiser or a State official appraiser praised by an APHIS official appraiser alone. Appraisals of eggs must be re- and a State official appraiser jointly, ported on forms furnished by APHIS or, if APHIS and State authorities and signed by the appraisers and must agree, by either an APHIS official ap- be signed by the owners of the eggs to praiser or a State official appraiser indicate agreement with the appraisal alone. For laying hens, the appraised amount. Appraisals of eggs must be value should include the hen’s pro- signed by the owners of the eggs prior jected future egg production. Apprais- to the destruction of the poultry, un- als of poultry must be reported on less the owners, APHIS, and the Co- forms furnished by APHIS and signed operating State Agency agree that the by the appraisers and must be signed eggs may be destroyed immediately. by the owners of the poultry to indi- Reports of appraisals must show the cate agreement with the appraisal number of eggs and the value per egg. amount. Appraisals of poultry must be (c) Cleaning and disinfection. (1) In- signed by the owners of the poultry demnity for cleaning and disinfection prior to the destruction of the poultry, of premises, conveyances, and mate- unless the owners, APHIS, and the Co- rials that came into contact with poul- operating State Agency agree that the try that are infected with or exposed to poultry may be destroyed immediately. H5/H7 LPAI will be based on receipts or Reports of appraisals must show the other documentation maintained by number of birds and the value per head. the claimant verifying expenditures for (2) Indemnity for disposal of poultry cleaning and disinfection activities au- infected with or exposed to H5/H7 LPAI thorized by this part. Any cleaning and will be based on receipts or other docu- disinfection of premises, conveyances,

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and materials for which indemnity is § 56.5 Destruction and disposal of requested must be performed under a poultry and cleaning and disinfec- compliance agreement between the tion of premises, conveyances, and claimant, the Cooperating State Agen- materials. cy, and APHIS. APHIS will review (a) Destruction of poultry. Poultry claims for indemnity for cleaning and that are infected with or exposed to H5/ disinfection to ensure that all expendi- H7 LPAI may be required to be de- tures relate directly to activities destroyed at the discretion of the Cooper- scribed in § 56.5 and in the initial State ating State Agency and APHIS and in response and containment plan de- accordance with the initial State re- scribed in § 56.10. sponse and containment plan described (2) In the case of materials, if the in § 56.10. The Cooperating State Agen- cy and APHIS will select a method to cost of cleaning and disinfection would use for the destruction of such poultry exceed the value of the materials or based on the following factors: cleaning and disinfection would be im- (1) The species, size, and number of practicable for any reason, indemnity the poultry to be destroyed; for the destruction of the materials (2) The environment in which the will be based on the fair market value poultry are maintained; of those materials, as determined by an (3) The risk to human health or safe- appraisal. Materials will be appraised ty of the method used; by an APHIS official appraiser and a (4) Whether the method requires spe- State official appraiser jointly, or, if cialized equipment or training; APHIS and State authorities agree, by (5) The risk that the method poses of either an APHIS official appraiser or a spreading the H5/H7 LPAI virus; State official appraiser alone. Indem- (6) Any hazard the method could pose nity for disposal of the materials will to the environment; be based on receipts or other docu- (7) The degree of bird control and re- mentation maintained by the claimant straint required to administer the de- verifying expenditures for disposal ac- struction method; tivities authorized by this part. Ap- (8) The speed with which destruction praisals of materials must be reported must be conducted; and on forms furnished by APHIS and (9) Consistency of the method with humane euthanasia guidelines. signed by the appraisers and must be (b) Disposal of poultry. Carcasses of signed by the owners of the materials poultry that have died from H5/H7 to indicate agreement with the ap- LPAI infection or poultry that have praisal amount. Appraisals of mate- been humanely slaughtered to fulfill rials must be signed prior to the de- depopulation requirements must be dis- struction of the materials, unless the posed of promptly and efficiently in ac- owners, APHIS, and the Cooperating cordance with the initial State re- State Agency agree that the materials sponse and containment plan described may be destroyed immediately. Any in § 56.10 to prevent the spread of H5/H7 disposal of materials for which indem- LPAI infection. Disposal methods will nity is requested must be performed be selected by the Cooperating State under a compliance agreement between Agency and APHIS and may include the claimant, the Cooperating State one or more of the following: Burial, Agency, and APHIS. APHIS will review incineration, composting, or rendering. claims for compensation for disposal to Regardless of the method used, strict ensure that all expenditures relate di- biosecurity procedures must be imple- rectly to activities described in § 56.5 mented and enforced for all personnel and in the initial State response and and vehicular movement into and out containment plan described in § 56.10. of the area in accordance with the initial State response and containment (Approved by the Office of Management and plan to prevent dissemination of the Budget under control number 0579–0007) H5/H7 LPAI virus. [71 FR 56323, Sept. 26, 2006, as amended at 75 (c) Controlled marketing. (1) At the FR 10657, Mar. 9, 2010] discretion of the Cooperating State Agency and APHIS, poultry that has

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been infected with or exposed to H5/H7 infected with or exposed to H5/H7 LPAI LPAI may be allowed to move for con- on a premises, the following procedures trolled marketing in accordance with should be completed prior to cleaning the initial State response and contain- and disinfection: ment plan described in § 56.10 and in ac- (i) Secure and remove all feathers cordance with the following require- that might blow around outside the ments: house in which the infected or exposed (i) Poultry infected with or exposed poultry were held by raking them to- to H5/H7 LPAI must not be transported gether and burning the pile; to a market for controlled marketing (ii) Apply insecticides and until 21 days after the acute phase of rodenticides immediately after the re- the infection has concluded, as deter- moval of the birds, before the house mined by the Cooperating State Agen- cools; cy in accordance with the initial State (iii) Close the house in which the response and containment plan de- poultry were held, maintaining just scribed in § 56.10; and enough ventilation to remove mois- (ii) Within 7 days prior to slaughter, ture. Heat the house to 100 °F and begin each flock to be moved for controlled in-house composting. Leave the house marketing must be tested for H5/H7 undisturbed for a minimum of 21 days LPAI using a test approved by the Co- and for as long as possible thereafter, operating State Agency and found to in order to allow as much H5/H7 LPAI be free of the virus. virus as possible to die a natural death. (2) Poultry moved for controlled mar- (iv) Heat the house to 100 °F for the keting will not be eligible for indem- 72 hours prior to cleaning and disinfec- nity under § 56.3. However, any costs re- tion. lated to cleaning and disinfection of (2) Cleaning and disinfection. All premises, conveyances, and materials premises, conveyances, and materials that came into contact with poultry that came into contact with poultry that are moved for controlled mar- that were infected with or exposed to keting will be eligible for indemnity H5/H7 LPAI must be cleaned and dis- under § 56.3. infected. Cleaning and disinfection (d) Cleaning and disinfection of prem- must be performed on all buildings ises, conveyances, and materials. Prem- that came into contact with poultry ises, conveyances, and materials that that were infected with or exposed to came into contact with poultry in- H5/H7 LPAI within a premises, includ- fected with or exposed to H5/H7 LPAI ing pumphouses and service areas. To must be cleaned and disinfected; Pro- accomplish cleaning and disinfection, vided, that materials for which the cost the following procedures should be of cleaning and disinfection would ex- completed: ceed the value of the materials or for (i) Disposal of manure, debris, and feed. which cleaning and disinfection would Clean up all manure, debris, and feed. be impracticable for any reason may be Compost manure, debris, and feed in destroyed and disposed. Cleaning and the house if possible. If this is not pos- disinfection must be performed in ac- sible, set up a system for hauling ma- cordance with the initial State re- nure, debris, and feed to an approved sponse and containment plan described site for burial, piling, or composting. in § 56.10, which must be approved by Do not clean out the house or move or APHIS. Cleaning and disinfection must spread litter until any H5/H7 LPAI also be performed in accordance with virus that may have contaminated the any applicable State and local environ- manure and litter is dead, as deter- mental regulations. This paragraph (d) mined by the Cooperating State Agen- provides guidelines for the develop- cy and in accordance with the initial ment of a cleaning and disinfection State response and containment plan plan for a premises and for the mate- described in § 56.10. If composting is rials and conveyances on that prem- used as a disposal method, manure and ises. litter should be composted in accord- (1) Preparation for cleaning and dis- ance with State and local regulations. infection. Following the depopulation If litter is piled, the litter pile must be or controlled marketing of all poultry covered and allowed to sit undisturbed

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for an amount of time approved by the and other closed areas to ensure ade- Cooperating State Agency and APHIS quate disinfection. and in accordance the initial State re- (vi) Cleaning and disinfection of con- sponse and containment plan described veyances. Clean and disinfect all trucks in § 56.10. Drying and heat in situ over and vehicles used in transporting af- time are effective and may be used in fected poultry or materials before soil place of composting if weather condi- dries in place. Both exterior, including tions or conditions in the building are the undercarriage, and interior sur- favorable. After use, equipment used to faces, including truck cabs, must be clean out manure, debris, and feed cleaned. The interior of the truck cabs must be cleaned, disinfected, and in- should be washed with clean water and spected at the site to which the ma- sponged with a disinfectant authorized nure and litter was transported. In the in § 71.10(a) of this chapter. Manure and case of inclement weather, the equip- litter removed from these vehicles ment may be cleaned, disinfected, and should be handled in a manner similar inspected at off-site wash stations at to that described in paragraph (d)(2)(i) the discretion of the Cooperating State of this section. Agency and APHIS. (3) Activities after cleaning and dis- (ii) Cleaning of premises and materials. infection. Premises should be checked Cleaning and washing should be thor- for virus before repopulation in accord- ough to ensure that all materials or ance with the initial State response substances contaminated with H5/H7 and containment plan described in LPAI virus, especially manure, dried § 56.10. The premises may not be re- blood, and other organic materials, are stocked with poultry until after the removed from all surfaces. Spray all date specified in the initial State re- contaminated surfaces above the floor sponse and containment plan described with detergent and water to knock in § 56.10. dust down to the floor, using no more (4) Destruction and disposal of mate- water than necessary. Wash equipment rials. In the case of materials for which and houses with detergent and water. the cost of cleaning and disinfection Disassemble equipment as required to would exceed the value of the mate- clean all contaminated surfaces. Spe- rials or for which cleaning and disinfec- cial attention should be given to auto- tion would be impracticable for any matic feeders and other closed areas to reason, the destruction and disposal of ensure adequate cleaning. Inspect the materials must be conducted in ac- houses and equipment to ensure that cordance with the initial State re- cleaning has removed all contaminated sponse and containment plan described materials or substances. Rinse with in § 56.10. fresh water and let houses and equip- [71 FR 56323, Sept. 26, 2006, as amended at 75 ment dry completely before applying FR 10657, Mar. 9, 2010] disinfectant. (iii) Disinfection of premises and mate- § 56.6 Presentation of claims for in- rials. When cleaning has been com- demnity. pleted and all surfaces are dry, all inte- Claims for the following must be doc- rior surfaces of the structure should be umented on a form furnished by APHIS saturated with a disinfectant reg- and presented to an APHIS employee istered with the U.S. Environmental or the State representative authorized Protection Agency (EPA) for AI virus to accept the claims: per label instructions or a disinfectant (a) Compensation for the value of approved by the EPA for use under a poultry to be destroyed due to infec- Federal Insecticide, Rodenticide, and tion with or exposure to H5/H7 LPAI; Fungicide Act section 18 exemption. A (b) Compensation for the value of power spray unit should be used to eggs to be destroyed during testing for spray the disinfectant on all surfaces H5/H7 LPAI; and that may be treated with the disinfect- (c) Compensation for the cost of ant according to its EPA label, making cleaning and disinfection of premises, sure that the disinfectant gets into conveyances, and materials that came cracks and crevices. Special attention into contact with poultry infected with should be given to automatic feeders or exposed to H5/H7 LPAI, or, in the

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case of materials, if the cost of clean- the Administrator may pay contrac- ing and disinfection would exceed the tors eligible for compensation under value of the materials or cleaning and this section 100 percent of the indem- disinfection would be impracticable for nity determined in paragraph (a) of any reason, the cost of destruction and this section. disposal for the materials. (2) If indemnity for the destroyed poultry or eggs is being provided for 25 (Approved by the Office of Management and Budget under control number 0579–0007) percent of eligible costs under § 56.3(b), the Administrator may pay contrac- [71 FR 56323, Sept. 26, 2006, as amended at 75 tors eligible for compensation under FR 10657, Mar. 9, 2010] this section 25 percent of the indemnity determined in paragraph (a) of § 56.7 Mortgage against poultry or eggs. this section. (c) If a contractor receiving indem- When poultry or eggs have been de- nity under this section has received stroyed under this part, any claim for any payment under his or her contract indemnity must be presented on forms from the owner of the poultry or eggs furnished by APHIS. The owner of the at the time the poultry or eggs are de- poultry or eggs must certify on the stroyed, the amount of indemnity for forms that the poultry or eggs covered which the contract grower is eligible are, or are not, subject to any mort- will be reduced by the amount of the gage as defined in this part. If the payment the contract grower has al- owner states there is a mortgage, the ready received. owner and each person holding a mort- (d) If indemnity is paid to a con- gage on the poultry or eggs must sign tractor under this section, the owner of the APHIS-furnished form, consenting the poultry or eggs will be eligible to to the payment of indemnity to the receive the difference between the in- person specified on the form. demnity paid to the growers and the (Approved by the Office of Management and total amount of indemnity that may be Budget under control number 0579–0007) paid for the poultry or eggs. (e) In the event that determination of [71 FR 56323, Sept. 26, 2006, as amended at 75 FR 10657, Mar. 9, 2010] indemnity to a party with which the owner of destroyed poultry or eggs has § 56.8 Conditions for payment. entered into a contract for the growing (a) When poultry or eggs have been or care of the poultry or eggs using the destroyed pursuant to this part, the method described in paragraph (a) of Administrator may pay claims to any this section is determined to be im- party with which the owner of the practical or inappropriate, APHIS may poultry or eggs has entered into a con- use any other method that the Admin- tract for the growing or care of the istrator deems appropriate to make poultry or eggs. The indemnity the Ad- that determination. ministrator may pay to such a party or [71 FR 56323, Sept. 26, 2006, as amended at 75 parties shall be determined as follows: FR 10657, Mar. 9, 2010] (1) Divide the value of the contract the owner of the poultry or eggs en- § 56.9 Claims not allowed. tered into with another party for the (a) The Department will not allow growing and care of the poultry or eggs claims arising out of the destruction of in dollars by the duration of the con- poultry unless the poultry have been tract as it was signed prior to the H5/ appraised as prescribed in this part and H7 LPAI outbreak in days; the owners have signed the appraisal (2) Multiply this figure by the time in form indicating agreement with the ap- days between the date the other party praisal amount as required by began to provide services relating to § 56.4(a)(1). the destroyed poultry or eggs under the (b) The Department will not allow contract and the date the poultry or claims arising out of the destruction of eggs were destroyed due to H5/H7 LPAI. poultry unless the owners have signed (b)(1) If indemnity for the destroyed a written agreement with APHIS in poultry or eggs is being provided for 100 which they agree that if they maintain percent of eligible costs under § 56.3(b), poultry in the future on the premises

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used for poultry for which indemnity is (2) A minimum biosecurity plan fol- paid, they will maintain the poultry in lowed by all poultry producers; accordance with a plan set forth by the (3) Provisions for adequate diagnostic Cooperating State Agency and will not resources; introduce poultry onto the premises (4) Detailed, specific procedures for until after the date specified by the Co- initial handling and investigation of operating State Agency. Persons who suspected cases of H5/H7 LPAI; do not maintain their poultry and (5) Detailed, specific procedures for premises in accordance with this writ- reporting test results to APHIS. These ten agreement will not be eligible to procedures must be developed after ap- receive indemnity under this part. propriate consultation with poultry (c) The Department will not allow producers in the State and must pro- claims arising out of the destruction of vide for the reporting only of con- poultry unless the poultry have been firmed cases of H5/H7 LPAI in accord- moved or handled by the owner in ac- ance with § 146.13 of this chapter; cordance with an agreement for the (6) Detailed, strict quarantine meas- control and eradication of H5/H7 LPAI ures for presumptive and confirmed and in accordance with part 56, for any index cases; progeny of any poultry unless the poul- (7) Provisions for developing flock try have been moved or handled by the plans for infected and exposed flocks; owner in accordance with an agree- (8) Detailed plans for disposal of in- ment for the control and eradication of fected flocks, including preexisting H5/H7 LPAI and in accordance with agreements with regulatory agencies part 56, or for any poultry that become and detailed plans for carcass disposal, or have become infected with or ex- disposal sites, and resources for con- posed to H5/H7 LPAI because of actions ducting disposal, and detailed plans for not in accordance with an agreement disposal of materials that come into for the control and eradication of H5/H7 contact with poultry infected with or LPAI or a violation of this part. exposed to H5/H7 LPAI; (Approved by the Office of Management and (9) Detailed plans for cleaning and Budget under control number 0579–0007) disinfection of premises, repopulation, and monitoring after repopulation; [71 FR 56323, Sept. 26, 2006, as amended at 75 FR 10657, Mar. 9, 2010] (10) Provisions for appropriate control/monitoring zones, contact surveys, § 56.10 Initial State response and con- and movement restrictions; tainment plan. (11) Provisions for monitoring activi- (a) In order for poultry owners within ties in control zones; a State to be eligible for indemnity for (12) If vaccination is considered as an 100 percent of eligible costs under option, a written plan for use in place § 56.3(b), the State in which the poultry with proper controls and provisions for participate in the Plan must have in APHIS approval of any use of vaccine; place an initial State response and con- (13) Plans for H5/H7 LPAI-negative tainment plan that has been approved flocks that provide for quarantine, by APHIS. The initial State response testing, and controlled marketing; and and containment plan must be devel- (14) Public awareness and education oped by the Official State Agency. In programs regarding avian influenza. States where the Official State Agency (b) If a State is designated a U.S. is different than the Cooperating State Avian Influenza Monitored State, Lay- Agency, the Cooperating State Agency ers under § 146.24(a) of this chapter or a must also participate in the develop- U.S. Avian Influenza Monitored State, ment of the plan. The plan must be ad- Turkeys under § 146.44(a) of this chap- ministered by the Cooperating State ter, it will lose that status during any Agency of the relevant State. This plan outbreak of H5/H7 LPAI and for 90 days must include: after the destruction and disposal of all (1) Provisions for a standing emer- infected or exposed birds and cleaning gency disease management committee, and disinfection of all affected prem- regular meetings, and exercises, in- ises are completed. cluding coordination with any tribal [71 FR 56323, Sept. 26, 2006, as amended at 75 governments that may be affected; FR 10658, Mar. 9, 2010]

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PART 70—RULES OF PRACTICE Subpart B—Supplemental Rules of GOVERNING PROCEEDINGS Practice UNDER CERTAIN ACTS § 70.10 Stipulations. Subpart A—General (a) At any time prior to the issuance of a complaint seeking a civil penalty Sec. under any of the Acts listed in § 70.1, 70.1 Scope and applicability of rules of prac- the Administrator, in his discretion, tice. may enter into a stipulation with any person in which: Subpart B—Supplemental Rules of Practice (1) The Administrator or the Admin- 70.10 Stipulations. istrator’s delegate gives notice of an apparent violation of the Act, or the AUTHORITY: 7 U.S.C. 8301–8317; 7 CFR 2.22, regulations issued thereunder, by such 2.80, and 371.4. person and affords such person an op- SOURCE: 48 FR 30094, June 30, 1983, unless portunity for a hearing regarding the otherwise noted. matter as provided by the Act; (2) Such person expressly waives Subpart A—General hearing and agrees to pay a specified penalty within a designated time; and § 70.1 Scope and applicability of rules (3) The Administrator agrees to ac- of practice. cept the penalty in settlement of the The Uniform Rules of Practice for particular matter involved if the penalty is paid within the designated time. the Department of Agriculture promul- (b) If the penalty is not paid within gated in subpart H of part 1, subtitle A, the time designated in such a stipula- title 7, Code of Federal Regulations, tion, the amount of the stipulated pen- are the Rules of Practice applicable to alty shall not be relevant in any re- adjudicatory, administrative pro- spect to the penalty which may be as- ceedings under the following statutory sessed after issuance of a complaint. provisions: Act of May 29, 1884, commonly known as the PART 71—GENERAL PROVISIONS Animal Industry Act, section 7, as amended (21 U.S.C. 117), Sec. Act of February 2, 1903, commonly known as 71.1 Definitions. the Cattle Contagious Diseases Act of 1903, 71.2 Secretary to issue rule governing quar- Section 3, as amended (21 U.S.C. 122), antine and interstate movement of dis- Act of March 3, 1905, Section 6, as amended eased animals, including poultry. (21 U.S.C. 127), 71.3 Interstate movement of diseased ani- Act of July 2, 1962, Section 6(a), as amended mals and poultry generally prohibited. (21 U.S.C. 134e). 71.4 Maintenance of certain facilities and premises in a sanitary condition re- The Animal Health Protection Act (7 U.S.C. quired; cleaning and disinfection, when 8301 et seq.). required; animals classed as ‘‘exposed.’’ Sections 901–905 of the Federal Agriculture 71.5 Unsanitary railroad cars, trucks, boats, Improvement and Reform Act of 1996 (7 aircraft or other means of conveyance; U.S.C. 1901 note). interstate movement restricted. 71.6 Carrier responsible for cleaning and dis- In addition, the Supplemental Rules of infecting of railroad cars, trucks, boats, Practice set forth in subpart B of this aircraft or other means of conveyance. part shall be applicable to such pro- 71.7 Means of conveyance, facilities, prem- ceedings. ises, and cages and other equipment; methods of cleaning and disinfecting. [48 FR 30094, June 30, 1983, as amended at 66 71.10 Permitted disinfectants. FR 63615, Dec. 7, 2001; 68 FR 6343, Feb. 7, 2003] 71.11 Cresylic disinfectant as permitted disinfectant; specifications.

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71.12 Sodium orthophenylphenate as per- assigned to the manufacturer of the mitted disinfectant for premises infected identification device by the Inter- with tuberculosis. national Committee on Animal Record- 71.13 Inspection of shipments in transit by APHIS representative. ing. The AIN beginning with the 840 71.14 Slaughter of poultry or other animals prefix may be used only on animals to prevent spread of disease; ascertain- born in the United States. ment of value and compensation. APHIS representative. An individual 71.15 Movement from quarantined to free employed by APHIS who is authorized area and shipment therefrom; conditions to perform the function involved. under which permitted. Approved livestock facility. A stock- 71.16 Inspection and certification of poultry or other animals for interstate move- yard, livestock market, buying station, ment. concentration point, or any other 71.17 Interstate movement of dead poultry premises under State or Federal veteri- or other animals prohibited in same car nary supervision where livestock are with live poultry or other animals. assembled and that has been approved 71.18 Individual identification of certain under § 71.20. cattle 2 years of age or over for move- Area veterinarian in charge. The vet- ment in interstate commerce. 71.19 Identification of swine in interstate erinary official of APHIS who is as- commerce. signed by the Administrator to super- 71.20 Approval of livestock facilities. vise and perform the official animal 71.21 Tissue and blood testing at slaughter. health work of the Animal and Plant 71.22 Removal and loss of official identifica- Health Inspection Service in the State tion devices. concerned. AUTHORITY: 7 U.S.C. 8301–8317; 7 CFR 2.22, Breeding sheep and goats. Any sexu- 2.80, and 371.4. ally intact sheep or goat that is not SOURCE: 28 FR 5937, June 13, 1963, unless moving either directly to slaughter or otherwise noted. through one or more restricted sales and/or terminal feedlots and then di- § 71.1 Definitions. rectly to slaughter. As used in this part, the following Breeder swine. Sexually intact swine terms shall have the meanings set over 6 months of age. forth in this section. Commingling. The mixing or assem- Accredited veterinarian. A veteri- bling of swine from one premises with narian who is approved by the Admin- swine from any other premises, includ- istrator, in accordance with part 161 of ing, but not limited to, loading swine this chapter, to perform official animal from more than one premises on the health work of the Animal and Plant same truck, trailer, vessel, or railroad Health Inspection Service specified in car, unless swine from different prem- subchapters A, B, C, and D of this chap- ises are kept separate on the means of ter and to perform work required by conveyance by dividers. cooperative State-Federal disease con- Consistent States. Those States listed trol and eradication programs. as consistent States in § 79.1 of this Administrator. The Administrator, subchapter because they meet certain Animal and Plant Health Inspection standards, as provided in § 79.6 of this Service, or any person authorized to subchapter, for conducting an active act for the Administrator. State scrapie program involving the Animal and Plant Health Inspection identification of scrapie in sheep and Service. The Animal and Plant Health goats for the purpose of controlling the Inspection Service of the United States spread of scrapie. Department of Agriculture (APHIS). Department. The United States De- Animal identification number (AIN). A partment of Agriculture. numbering system for the official iden- Feeder swine. Swine under 6 months tification of individual animals in the of age that are not slaughter swine. United States providing a nationally Food Safety and Inspection Service unique identification number for each (FSIS). The Food Safety and Inspection animal. The AIN contains 15 digits, Service, United States Department of with the first 3 being the country code Agriculture. (840 for the United States), the alpha Free area. The States, Territories, or characters USA, or the numeric code the District of Columbia or portions

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thereof not quarantined by the Sec- including any disease of regulatory retary of Agriculture for the specific concern to APHIS or to the States in- contagious, infectious, or commu- volved, and an accurate statement that nicable animal disease mentioned in swine on the premises from which the each part. swine are to be moved have been in- Group/lot identification number (GIN). spected by the swine production sys- The identification number used to tem accredited veterinarian(s) within uniquely identify a ‘‘unit of animals’’ 30 days prior to the interstate move- of the same species that is managed to- ment and consistent with the dates gether as one group throughout the specified by the premises’ swine pro- preharvest production chain. The GIN duction health plan and found free consists of a seven-character premises from signs of communicable disease. identification number (PIN), as defined Livestock. Horses, cattle, bison, in this section, a six-digit representa- cervids, camelids, sheep, goats, swine, tion of the date on which the group or and other farm-raised animals. lot of animals was assembled (MM/DD/ Livestock market. A stockyard, buying YY), and two additional digits, ranging station, concentration point, or any from 01 to 99, for the numbering of dif- other premises where livestock are as- ferent groups or lots of animals assem- sembled for sale or sale purposes. bled on the same premises on the same Moved (movement) in interstate com- day. When more than one group of ani- merce. Shipped, transported, delivered, mals is assembled, the groups will be or otherwise aided, induced, or caused designated consecutively as 01, 02, 03, to be moved from the point of origin of etc. the interstate movement to the ani- Horses. Horses, asses, mules, ponies, mals’ final destination, such as a and zebras. slaughtering establishment or a farm Inconsistent States. Those States not for breeding or raising, and including included in the list of consistent States any temporary stops along the way, appearing in § 79.1 of this subchapter. such as at a stockyard or dealer prem- Interstate. From one State into or ises for feed, water, rest, or sale. through any other State. Official Brand Inspection Agency. The Interstate commerce. Trade, traffic, duly constituted body elected, ap- transportation, or other commerce be- pointed, or delegated or granted au- tween a place in a State and any place thority by a State or governmental outside of that State, or between subdivision thereof, to administer laws, points within a State but through any regulations, ordinances or rules per- place outside of that State. taining to the brand identification of Interstate swine movement report. A livestock. paper or electronic document signed by Official brand inspection certificate. A a producer moving swine giving notice certificate issued by an official brand that a group of animals is being moved inspection agency in any State in across State lines in a swine produc- which such certificates are required for tion system. This document must con- movement of livestock. tain the name of the swine production Official eartag. An identification tag system; the name, location, and prem- providing unique identification for in- ises identification number of the prem- dividual animals. An official eartag ises from which the swine are to be which contains or displays an AIN with moved; the name, location, and prem- an 840 prefix must bear the U.S. shield. ises identification number of the prem- The design, size, shape, color, and ises to which the swine are to be other characteristics of the official moved; the date of movement; and the eartag will depend on the needs of the number, age, and type of swine to be users, subject to the approval of the moved. This document must also con- Administrator. The official eartag tain a description of any individual or must be tamper-resistant and have a group identification associated with high retention rate in the animal. Offi- the swine, the name of the swine pro- cial eartags must adhere to one of the duction system accredited veteri- following numbering systems: narian(s), the health status of the herd (1) National Uniform Eartagging Sys- from which the swine are to be moved, tem.

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(2) Animal identification number (2) A seven-character alphanumeric (AIN). code, with the right-most character (3) Premises-based number system. being a check digit. The check digit The premises-based number system number is based upon the ISO 7064 Mod combines an official premises identi- 36/37 check digit algorithm. fication number (PIN), as defined in Purebred registry association. A swine this section, with a producer’s live- breed association formed and perpet- stock production numbering system to uated for the maintenance of records of provide a unique identification num- purebreeding of swine species for a spe- ber. The PIN and the production num- cific breed whose characteristics are ber must both appear on the official set forth in constitutions, by-laws, and tag. other rules of the association. (4) Any other numbering system ap- Quarantined area. The States, Terri- proved by the Administrator for the tories, or the District of Columbia or identification of animals in commerce. portions thereof quarantined by the Official identification device or method. Secretary of Agriculture for the spe- A means of officially identifying an cific contagious, infectious, or commu- animal or group of animals using de- nicable animal disease mentioned in vices or methods approved by the Ad- each part. ministrator, including, but not limited Slaughter swine. Swine being sold or to, official tags, tattoos, and registered moved for slaughter purposes only. brands when accompanied by a certifi- State. Any of the 50 States, the Com- cate of inspection from a recognized brand inspection authority. monwealth of Puerto Rico, the Com- Official swine tattoo. A tattoo, con- monwealth of the Northern Mariana Is- forming to the six-character alpha-nu- lands, the District of Columbia, and meric National Tattoo System, that any territories and possessions of the provides a unique identification for United States. each herd or lot of swine. State animal health official. The State Person. Any individual, corporation, official responsible for livestock and company, association, firm, partner- poultry disease control and eradication ship, society, or joint stock company, programs. or other legal entity. State representative. An individual em- Premises. A location where livestock ployed in animal health work by a or poultry are housed or kept. State or a political subdivision thereof Premises identification number (PIN). A and authorized by such State or polit- nationally unique number assigned by ical subdivision to perform the func- a State, Tribal, and/or Federal animal tion involved. health authority to a premises that is, Swine production health plan. A writ- in the judgment of the State, Tribal, ten agreement developed for a swine and/or Federal animal health author- production system designed to main- ity, a geographically distinct location tain the health of the swine and detect from other premises. The premises signs of communicable disease. identification number is associated The plan must identify all premises with an address, geospatial coordi- that are part of the swine production nates, and/or location descriptors system and that receive or send swine which provide a verifiably unique loca- in interstate commerce and must pro- tion. The premises identification num- vide for health monitoring of all swine ber may be used in conjunction with a within the system. Such health moni- producer’s own livestock production toring must include inspections by the numbering system to provide a unique swine production system accredited identification number for an animal. It veterinarian(s). Inspections of all iden- may also be used as a component of a tified premises that contain swine that group/lot identification number (GIN). are or will be in the process of moving The premises identification number interstate within the swine production may consist of: system and of all swine on those prem- (1) The State’s two-letter postal ab- ises must be conducted by the accred- breviation followed by the premises’ ited veterinarian(s) at intervals of no assigned number; or greater than 30 days. Inspections of all

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identified receiving premises that con- APHIS that provides unique identifica- tain only swine that have completed tion for each animal. their interstate movement within a [28 FR 5937, June 13, 1963] single swine production system and of all swine on those premises must be EDITORIAL NOTE: For FEDERAL REGISTER ci- conducted in accordance with State tations affecting § 71.1, see the List of CFR Sections Affected, which appears in the regulations. The plan must also de- Finding Aids section of the printed volume scribe the recordkeeping system of the and at www.fdsys.gov. swine production system. The plan will not be valid unless it is signed by an of- § 71.2 Secretary to issue rule gov- ficial of each swine production system erning quarantine and interstate identified in the plan, the swine pro- movement of diseased animals, including poultry. duction system accredited veterinarian(s), an APHIS representative, When the Secretary of Agriculture and the State animal health official shall determine the fact that poultry from each State in which the swine or other animals in any State, Terri- production system has premises. In the tory, or the District of Columbia are plan, the swine production system affected with any contagious, infec- must acknowledge that it has been in- tious, or communicable disease of live- formed of and has notified the man- stock or poultry for which, in his opin- agers of all its premises listed in the ion, a quarantine should be established plan that any failure of the partici- or that other basis for a quarantine ex- pants in the swine production system ists, notice will be given of that fact, to abide by the provisions of the plan and a rule will be issued accordingly, placing in quarantine such State, Ter- and the applicable provisions of this ritory, or the District of Columbia, or part and part 85 of this chapter con- specified portion thereof. This rule will stitutes a basis for the cancellation of either absolutely forbid the interstate the swine production health plan, as movement of the quarantined animals well as other administrative or crimi- from the quarantined area or will indi- nal sanctions, as appropriate. cate the regulations under which inter- Swine production system. A swine pro- state movements may be made. duction enterprise that consists of multiple sites of production; i.e., sow [34 FR 15641, Oct. 9, 1969] herds, nursery herds, and growing or § 71.3 Interstate movement of diseased finishing herds, but not including animals and poultry generally pro- slaughter plants or livestock markets, hibited. that are connected by ownership or (a) Animals or poultry affected with contractual relationships, between any of the following diseases, which are which swine move while remaining endemic to the United States: Equine under the control of a single owner or piroplasmosis, bovine piroplasmosis or a group of contractually connected splenetic fever, scabies in cattle, owners. pseudorabies, acute swine erysipelas, Swine production system accredited vet- tuberculosis, Johne’s disease, brucel- erinarian. An accredited veterinarian losis, scrapie, bluetongue, anthrax, who is named in a swine production chlamydiosis, and Newcastle disease, health plan for a premises within a or any other communicable disease swine production system and who per- which is endemic to the United States, forms inspection of such premises and or which are cattle fever tick infested, animals and other duties related to the shall not be moved interstate. movement of swine in a swine produc- (b) Animals or poultry affected with tion system. any of the following diseases, not Tick infested. Infested with the ticks known to exist in the United States: Boophilus annulatus (Margaropus foot-and-mouth disease, rinderpest, Af- annulatus), Boophilus microplus, or rican swine fever, classical swine fever, Rhipicephalus evertsi evertsi. Teschen disease, contagious bovine United States. All of the States. pleuropneumonia, European fowl pest, United States Department of Agri- dourine, contagious equine metritis, culture backtag. A backtag issued by vesicular exanthema, screwworms and

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glanders, scabies in sheep or any other interstate; and the name and address of communicable foreign disease not the owner or shipper. known to exist in the United States, (1) Livestock affected with one or shall not be moved interstate. more of the following diseases may be (c) Notwithstanding the provisions of moved interstate for immediate paragraphs (a) and (b) of this section: slaughter to a slaughtering establish- (1) Domestic animals that have re- ment where State or Federal meat in- acted to an official test for brucellosis, spection is maintained; Actinomycosis, are not affected with any other disease actinobacillosis, anaplasmosis, atroph- referred to in this section, and are not ic rhinitis, contagious ecthyma, foot tick infested may be moved interstate rot, infectious keratitis, ram in accordance with part 78 of this chap- epididymitis, ringworm, swine influ- ter. enza, arthritis (simple lesions only), (2) Domestic animals that are posi- and shipping fever. tive to an official Johne’s disease test, (2) Cattle with slight unopened cases are not affected with any other disease of actinomycosis or actinobacillosis (or referred to in this section, and are not both) may be moved interstate to a tick infested may be moved interstate feed lot in the State of destination: in accordance with part 80 of this chap- Provided, That such cattle are not after. fected with any other disease named in this paragraph. (3) Cattle which have reacted to the (3) Sheep affected with or exposed to tuberculin test, which are not affected contagious ecthyma may be moved with any other disease referred to in interstate to a feed lot located in a this section and are not tick infested, State the laws, rules, or regulations of may be moved interstate in accordance which require that such sheep be seg- with the provisions of § 77.17 of this regated or quarantined under a permit subchapter. from an official of such State: Provided, (4) Swine infected with or exposed to That such sheep are not affected with pseudorabies may be moved interstate any other disease named in this para- in accordance with part 85 of this chap- graph. ter. (4) Livestock affected with one or (5) [Reserved] more of the following diseases may be (6) Sheep or goats designated, with moved interstate for any purpose to a regard to scrapie, as exposed animals, State the laws, rules, or regulations of high-risk animals, suspect animals, or which require that such livestock be scrapie-positive animals, as those segregated or quarantined under a per- terms are defined in part 79 of this submit from the appropriate livestock chapter, may be moved interstate only sanitary official of such State: actino- in accordance with part 79 of this sub- mycosis, actinobacillosis, contagious chapter. ecthyma, foot rot, and shipping fever: (d) Notwithstanding the provisions of Provided, That such livestock is not af- paragraphs (a) and (b) of this section, fected with any other disease named in livestock which is found to be diseased this paragraph. may be moved interstate in accordance (5) Livestock affected with infectious with paragraphs (d)(1) through (6) of keratitis or ringworm (or both) may be this section: Provided, That such live- moved interstate for any purpose if stock is not tick infested or affected treated under the supervision of an with any disease referred to in this sec- APHIS or State representative or an tion other than the diseases named in accredited veterinarian prior to move- this paragraph: And provided further, ment: Provided, That such livestock is That such livestock is accompanied by not affected with any other disease a certificate, issued by an APHIS or named in this paragraph. Livestock af- State representative or accredited vet- fected with infectious keratitis or erinarian stating the destination of the ringworm (or both) and also with an- animals; the purpose for which they other disease named in this paragraph are to be moved; the number of animals may be moved interstate only under covered by the certificate; the point the applicable provisions of paragraphs from which the animals are moved (d)(1) through (4) of this section after

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being so treated for infectious keratitis EDITORIAL NOTE: For FEDERAL REGISTER ci- or ringworm (or both). Such livestock tations affecting § 71.3, see the List of CFR will be subject to further treatment at Sections Affected, which appears in the destination, if required. Finding Aids section of the printed volume and at www.fdsys.gov. (6) Fish affected with spring viremia of carp may be moved interstate only if EFFECTIVE DATE NOTE: At 73 FR 52184, they are being moved directly to a fa- Sept. 9, 2008, § 71.3 was amended in paragraph (a), in the list of diseases which are endemic cility to be processed into food for to the United States, by adding the words human consumption. ‘‘viral hemorrhagic septicemia,’’ after (7) Other movements. The Adminis- ‘‘chlamydiosis,’’; and by adding a new para- trator may provide for the movement, graph (c)(5), effective Nov. 10, 2008. At 73 FR not otherwise provided for in this para- 63867, Oct. 28, 2008, the effective date was de- graph, of animals affected with the dis- layed until Jan. 9, 2009. At 74 FR 1, Jan. 2, 2009, the effective date was delayed indefi- eases named in paragraph (d)(1) of this nitely. For the convenience of the user, the section, under such conditions as he added text is set forth as follows: may prescribe to prevent the spread of disease. The Administrator will § 71.3 Interstate movement of diseased ani- promptly notify the appropriate live- mals and poultry generally prohibited. stock sanitary officials of the States involved of any such action. * * * * * (e) Notwithstanding the provisions of (c) * * * paragraphs (a) and (b) of this section, (5) Fish affected with viral hemorrhagic the Administrator in specific cases and septicemia may be moved interstate in ac- under such conditions as he may pre- cordance with part 83 of this subchapter. scribe to prevent the dissemination of disease may provide for the interstate * * * * * movement of individual animals affected with contagious, infectious, or § 71.4 Maintenance of certain facilities communicable disease to a designated and premises in a sanitary condi- diagnostic or research facility when action required; cleaning and disinfection, when required; animals companied by a permit from the appro- classed as ‘‘exposed.’’ priate livestock sanitary official in the State of destination: Provided, That (a) Yards, pens, chutes, alleys, and animals so moved shall be maintained other facilities and premises which are in quarantine at such designated facil- used in connection with the interstate ity until freed of disease as determined movement of livestock or poultry shall by tests recognized by the Department, be maintained by the person in posses- until natural death, or until disposal sion of the facilities and premises in a by euthanasia. clean and sanitary condition, in accordance with good animal husbandry (f) Before offering cattle or other practices, and shall be subject to in- livestock or poultry for interstate spection by an APHIS or State rep- transportation, transporting them resentative. When an APHIS or State interstate, or introducing them into representative determines that such fa- any stockyards or upon routes of traf- cilities or premises are not in such fic for interstate transportation, all clean and sanitary condition and gives persons, companies, or corporations are written notice of his determination to required to exercise reasonable dili- such person, the facilities and premises gence to ascertain whether such ani- shall be cleaned and disinfected in ac- mals or poultry are affected with any cordance with §§ 71.7 and 71.10 through contagious, infectious, or commu- 71.12 by such person under the super- nicable disease, or have been exposed vision of an APHIS or State represent- to the contagion or infection of any ative or an accredited veterinarian be- such disease by contact with other ani- fore such premises are again used for mals or poultry so diseased or by loca- livestock or poultry. tion in pens, cars, or other vehicles, or (b) Yards, pens, chutes, alleys, and upon premises that have contained ani- other facilities and premises which mals or poultry so diseased. have contained interstate shipments of [28 FR 5937, June 13, 1963] cattle, sheep, swine, poultry, or other

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animals affected with, or carrying the which have been used in the interstate infection of, any contagious, infec- transportation of cattle, sheep, goats, tious, or communicable disease of live- swine, poultry, or other animals af- stock or poultry other than slight un- fected with, or carrying the infection opened cases of actinomycosis or acti- of, any contagious, infectious, or com- nobacillosis (or both), bovine foot rot, municable disease of livestock or poul- atrophic rhinitis, ram epididymitis, try, other than slight unopened cases ringworm, infectious keratitis, and ar- of actinomycosis or actinobacillosis (or thritis (simple lesions only), shall be both), atrophic rhinitis, bovine foot cleaned and disinfected under the su- rot, brucellosis, ram epididymitis, pervision of an APHIS or State rep- ringworm, infectious keratitis, and ar- resentative or an accredited veteri- thritis (simple lesions only), shall be narian in accordance with §§ 71.7 and cleaned and disinfected under APHIS 71.10 through 71.12 before such premises supervision in accordance with §§ 71.7 are again used for animals, and any and 71.10 through 71.12 at the point poultry or other animals unloaded into where the animals are unloaded and such yards or premises before they the final carrier shall be responsible have been so cleaned and disinfected for such cleaning and disinfecting: Pro- shall thereafter be classed as ‘‘ex- vided, That when APHIS supervision is posed’’ within the meaning of the regu- not available at such point, the means lations in this subchapter and shall not of conveyance may be cleaned and dis- be moved interstate except in compli- infected under the supervision of a ance with the provisions of such regu- State representative or an accredited lations applicable to ‘‘exposed’’ ani- veterinarian. mals. (b) No railroad car, truck, boat, aircraft or other means of conveyance [34 FR 15641, Oct. 9, 1969, as amended at 55 FR 11156, Mar. 27, 1990; 55 FR 15320, Apr. 23, 1990; from which poultry or other animals 62 FR 27933, May 22, 1997] affected with an infectious, contagious or communicable disease of livestock § 71.5 Unsanitary railroad cars, trucks, or poultry, other than those specified boats, aircraft or other means of in § 71.4(b), have been unloaded shall conveyance; interstate movement thereafter be used in connection with restricted. the interstate movement of animals, No person who receives notice from including poultry, or be moved inter- an APHIS representative that a rail- state until it has been cleaned and dis- road car, truck, boat, aircraft or other infected by the final carrier under the means of conveyance owned or oper- supervision of an APHIS or State rep- ated by such person is not in a clean resentative or an accredited veteri- and sanitary condition in accordance narian in accordance with §§ 71.7 and with good animal husbandry practices, 71.10 through 71.12. shall thereafter use such means of con- (c) If APHIS supervision or other su- veyance in connection with the inter- pervision as required by paragraph (a) state movement of livestock or poul- or (b) of this section or proper cleaning try, or move said means of conveyance and disinfecting facilities are not interstate, until it has been cleaned available at the point where the ani- and disinfected under the supervision mals are unloaded, upon permission of an APHIS or State representative or first received from the Animal and an accredited veterinarian in accord- Plant Health Inspection Service, the ance with §§ 71.7 and 71.10 through 71.12. means of conveyance may be forwarded empty to a point at which such super- [34 FR 15641, Oct. 9, 1969, as amended at 55 FR 11156, Mar. 27, 1990; 55 FR 15320, Apr. 23, 1990; vision and facilities are available, and 62 FR 27933, May 22, 1997] there be cleaned and disinfected under supervision in accordance with §§ 71.7 § 71.6 Carrier responsible for cleaning and 71.10 through 71.12. and disinfecting of railroad cars, trucks, boats, aircraft or other [34 FR 15641, Oct. 9, 1969, as amended at 37 FR means of conveyance. 25337, Nov. 30, 1972; 39 FR 4465, Feb. 4, 1974; 55 FR 11156, Mar. 27, 1990; 55 FR 15320, Apr. 23, (a) Railroad cars, trucks, boats, air- 1990; 62 FR 27934, May 22, 1997; 74 FR 14709, craft, and other means of conveyance Apr. 1, 2009]

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§ 71.7 Means of conveyance, facilities, (2) Liquefied phenol (U.S.P. strength premises, and cages and other 87 percent phenol) in the proportion of equipment; methods of cleaning at least 6 fluid ounces to 1 gallon of and disinfecting. water. (a) Railroad cars, trucks, aircraft, or (3) Chlorinated lime (U.S.P. strength, other means of conveyance, except 30 percent available chlorine) in the boats, required by the regulations in proportion of 1 pound to 3 gallons of this subchapter to be cleaned and dis- water. infected shall be treated in the fol- (4) Sodium hydroxide (Lye) prepared lowing manner: Remove all litter and in a fresh solution in the proportion of manure from all portions of the con- not less than 1 pound avoirdupois of so- veyance, including any external ledges dium hydroxide of not less than 95 per- and framework; clean the exterior and cent purity to 6 gallons of water, or interior of the conveyance; and satu- one 131⁄2 ounce can to 5 gallons of rate the entire interior surface, includ- water. Due to the extreme caustic na- ing the inner surface of the doors of the ture of sodium hydroxide solution, pre- conveyance, with a permitted dis- cautionary measures such as the wear- infectant specified in §§ 71.10 through ing of rubber gloves, boots, raincoat, 71.12. and goggles should be observed. An (b) Boats required by the regulations acid solution such as vinegar shall be in this subchapter to be cleaned and kept readily available in case any of disinfected shall be treated in the fol- the sodium hydroxide solution should lowing manner: Remove all litter and manure from the decks and stalls, and come in contact with the body. all other parts of the boat occupied or (5) Disinfectants which are registered traversed by any poultry or other ani- under the Federal Insecticide, Fun- mals and from the portable chutes or gicide, and Rodenticide Act (7 U.S.C. other appliances or fixtures used in 135 et seq.), with tuberculocidal claims, loading and unloading the animals, and as disinfectants for general use, may be saturate with a permitted disinfectant used for the purpose of this part in ac- the entire surface of the deck, stalls, or cordance with directions on the labels other parts of the boat occupied or tra- accepted in connection with their reg- versed by any animals or with which istration. However, disinfectants which they may come in contact or which fall in this category are not permitted have contained litter or manure. for use in outbreaks of foreign animal (c) Yards, pens, chutes, alleys, cages, diseases unless in specific cases such and other equipment required by the use is approved in advance by the Ad- regulations in this subchapter to be ministrator. disinfected shall be treated in the fol- (b) The use of ‘‘cresylic disinfectant’’ lowing manner: Empty all troughs, is permitted subject to the following racks, or other feeding or watering ap- conditions: pliances; remove all litter and manure (1) The manufacturer thereof shall from the floors, posts, or other parts; have obtained specific permission from and saturate the entire surface of the APHIS for the use of his products in of- fencing, troughs, chutes, floors, walls, ficial disinfection. To obtain such per- and other parts with a permitted dis- mission manufacturers shall first sub- infectant specified in §§ 71.10 through mit a sample of at least 8 ounces for 71.12. examination, together with a state- [34 FR 15642, Oct. 9, 1969, as amended at 61 FR ment of the formula employed and a 56883, Nov. 5, 1996] guaranty that the product will be maintained of a quality uniform with § 71.10 Permitted disinfectants. the sample submitted. (a) Disinfectants permitted for use on (2) To prevent confusion, the product cars, boats, and other vehicles, prem- of each manufacturer and distributor ises, and cages and other equipment shall bear a distinctive trade name or are as follows: brand, together with the name of the (1) ‘‘Cresylic disinfectant’’ in the pro- manufacturer or distributor. portion of at least 4 fluid ounces to 1 (3) The product shall at all times con- gallon of water. form to specifications for composition

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and performance issued by the Admin- § 71.12 Sodium orthophenylphenate as istrator. permitted disinfectant for premises infected with tuberculosis. [28 FR 5937, June 13, 1963, as amended at 32 FR 19157, Dec. 20, 1967; 37 FR 8864, May 2, (a) A permitted brand of sodium 1972; 37 FR 9460, May 11, 1972; 55 FR 11156, orthophenylphenate in a proportion of Mar. 27, 1990; 55 FR 15320, Apr. 23, 1990; 61 FR at least one pound to 12 gallons of 56883, Nov. 5, 1996] water is permitted in tuberculosis eradication work for disinfecting in- § 71.11 Cresylic disinfectant as per- fected premises following the removal mitted disinfectant; specifications. of cattle that reacted to the tuberculin The following specifications will be test. employed for determining the suit- (b) It is absolutely necessary that the ability of cresylic disinfectant for use solution be applied at a temperature of under the provisions of § 71.10(b)(3): 60 °F. or over. Whenever the tempera- (a) The product shall remain a uni- ture of the building to be disinfected is form liquid when held at 0 °C. (32 °F.) below 60 °F., as indicated by a wall for 3 hours (chill test). thermometer, the solution shall be (b) The product shall dissolve com- heated to 120 °F. and higher in very pletely in 30 parts of distilled water at cold weather, to insure effective dis- 25 °C. (77 °F.) within 2 minutes (solu- infection. tion-rate test), producing a solution entirely free from globules and not § 71.13 Inspection of shipments in more than faintly opalescent (solu- transit by APHIS representative. bility-degree test). All persons and corporations having (c) The product shall contain not control of the interstate transpor- more than 25 percent of inert ingredi- tation of livestock or poultry shall, ents (water and glycerin), not more ex- when directed by an APHIS inspector cess alkali than the equivalent of 0.5 so to do, stop the same in transit for percent of sodium hydroxide, and not inspection, and if any of such poultry less than 21 percent of soap exclusive of or other animals are found upon such water, glycerin, and excess alkali. inspection to be infected with any con- (d) The product shall contain not less tagious, infectious, or communicable than 50 percent and not more than 53 disease or to have been exposed to such percent of total phenols. It shall con- infection, the person or corporation tain less than 5 percent of benzophenol having control of the transportation of (C6H5OH). such poultry or other animals shall, (e) The methods of determining com- upon receipt of an order from an pliance with the specifications in para- APHIS representative so to do, cease graphs (a) to (d) of this section will be the carriage, transportation, or moving those described in United States De- of such poultry or other animals unless partment of Agriculture Bulletin 1308, such carriage, transportation, or mov- Chemical and Physical Methods for the ing can be accomplished in accordance Control of Saponified Cresol Solutions, so far as they are applicable. with the regulations in this subchapter governing the interstate movement of (f) Any suitable glyceride, fat acid, or poultry or other animals infected with resin acid may be used in preparing the soap, but not all are suitable nor are or which have been exposed to the in- all grades of a single product equally fection of such disease, and in all cases suitable, Also various grades of com- after the discovery of such infection or mercial cresylic acid differ in suit- exposure thereto such poultry or other ability. Therefore, manufacturers are animals shall be handled in accordance cautioned to prepare a trial laboratory with such regulations. batch from every set of ingredients and [28 FR 5937, June 13, 1963, as amended at 34 to prove its conformity with para- FR 15642, Oct. 9, 1969; 55 FR 11156, Mar. 27, graphs (a) and (b) of this section, before 1990; 55 FR 15320, Apr. 23, 1990; 62 FR 27934, proceeding with manufacture on a fac- May 22, 1997] tory scale.

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§ 71.14 Slaughter of poultry or other of such inspection or treatment and animals to prevent spread of dis- the result thereof is required by any of ease; ascertainment of value and the regulations in this subchapter as a compensation. condition precedent to the movement When, in order to prevent the spread interstate of any poultry or other ani- of any contagious, infectious, or com- mal or class of poultry or other ani- municable disease, it becomes nec- mals, or any poultry or other animal or essary to slaughter any diseased or ex- class of poultry or other animals is so posed animals, including poultry, and required to be accompanied in inter- the purchase of such animals, including state movement by such certificate, poultry, by the United States is au- statement, test chart, or other writing, thorized by law and an appropriation is no such poultry or other animal or available therefor, the value of the ani- poultry or other animals shall be mals, including poultry shall be moved interstate unless and until the ascertained and compensation made following requirements are also com- therefor in accordance with the orders plied with: or regulations of the Secretary of Agri- (1) In the case of such movement by culture. a common carrier issuing waybills or [28 FR 5937, June 13, 1963, as amended at 34 other form or forms of billing covering FR 15642, Oct. 9, 1969] the movement, the said certificate, statement, test chart, or other writing § 71.15 Movement from quarantined to shall be delivered to such carrier at the free area and shipment therefrom; time the poultry or other animal or conditions under which permitted. poultry or other animals are delivered No livestock or poultry shall be for shipment, and shall become the shipped, trailed, driven, or hauled in property of the carrier, and be by such private conveyance from the quar- carrier attached to the billing covering antined area in any State, Territory, the transportation of such poultry or or the District of Columbia to the free other animal or poultry or other ani- area in the same State, Territory, or mals, and accompany such billing to the District of Columbia and subse- destination, and be filed with such bill- quently delivered to a transportation ing for future reference. company for shipment or moved to any (2) In case of such movement other- other State, Territory, or the District wise than by common carrier issuing of Columbia without complying with waybills or other form or forms of bill- all Federal and State regulations pering, the said certificate, statement, taining to such movements. test chart, or other writing shall ac- [28 FR 5937, June 13, 1963, as amended at 34 company the poultry or other animal FR 15642, Oct. 9, 1969] or poultry or other animals to destination and be delivered to the consignees, § 71.16 Inspection and certification of or, in case the consignor and consignee poultry or other animals for inter- is the same person, to the first pur- state movement. chaser purchasing during or after such (a) Assistance and facilities. When movement in interstate commerce, or poultry or other animals are to be in- to the person to whom the poultry or spected and certified by an APHIS rep- other animal or poultry or other ani- resentative, assistance and proper fa- mals are delivered. cilities for restraining them shall be [28 FR 5937, June 13, 1963, as amended at 34 provided in order that a careful inspec- FR 15642, Oct. 9, 1969; 55 FR 11156, Mar. 27, tion may be made, and the representa- 1990; 55 FR 15320, Apr. 23, 1990; 62 FR 27934, tive while making the inspection shall May 22, 1997] not be interfered with in any manner; otherwise inspection will be imme- § 71.17 Interstate movement of dead diately discontinued. poultry or other animals prohibited (b) Certificates and other statements to in same car with live poultry or accompany shipments. Whenever inspec- other animals. tion or treatment and the issuance of a No dead poultry or other animals certificate, statement, test chart, or shall be offered or accepted for trans- other writing showing the performance portation or transported in the same

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car with live poultry or other animals other document 2 stating: (A) The point from the original point of shipment in from which the animals are moved any State or Territory or the District interstate; (B) the destination of the of Columbia to or through any other animals; (C) the number of animals State, Territory, or the District of Co- covered by the statement, or other doc- lumbia. ument; (D) the name and address of the owner at the time of the movement; (E) [28 FR 5937, June 13, 1963, as amended at 34 the name and address of the previous FR 15642, Oct. 9, 1969] owner if ownership changed within four months prior to the movement of the § 71.18 Individual identification of cer- cattle; (F) the name and address of the tain cattle 2 years of age or over for movement in interstate commerce. shipper; and (G) the identifying numbers of the backtags or other approved (a) No cattle 2 years of age or over, identification applied: Provided, That except steers and spayed heifers and identification numbers are not required cattle of any age which are being to be recorded on such statement or moved interstate during the course of document for cattle moved from a normal ranching operations without stockyard posted under the provisions change of ownership to another prem- of the Packers and Stockyards Act, ises owned, leased, or rented by the 1921, as amended (7 U.S.C. 181 et seq.), 3 same individual as provided in directly to a recognized slaughtering §§ 78.9(a)(3)(ii), 78.9(b)(3)(iv), and establishment as defined in § 78.1 of this 78.9(c)(3)(iv) of this chapter, shall be chapter; or moved in interstate commerce other (ii) May be moved in interstate com- than in accordance with the require- merce only from a farm, ranch, or feed- ments of this section. Any movement lot to a recognized slaughtering estab- in interstate commerce of any cattle lishment as defined in § 78.1 of this shall also comply with the other appli- chapter; or to a stockyard posted under cable provisions in this part and other the provisions of the Packers and parts of this subchapter. Stockyards Act, 1921, as amended (7 (1) When permitted under such other U.S.C. 181 et seq.), for sale and shipment provisions, cattle subject to this sec- to such a slaughtering establishment, tion: if such cattle are identified upon arrival at such slaughtering establish- (i) May be moved in interstate comment or stockyard by the application merce from any point to any destina- of Department-approved backtags or by tion, if such cattle, when moved in other approved identification as pre- interstate commerce, are identified by scribed in paragraph (a)(1)(i) of this 1 a Department-approved backtag af- section and, except as provided in para- fixed a few inches from the midline and graph (a)(5) of this section when moved just behind the shoulder of the animal, interstate, are accompanied by a state- or by such other means approved by ment signed by the owner or shipper of the Administrator, upon request in spe- the cattle, or other document 2 stating: cific cases, and if except as provided in (A) The point from which the animals paragraph (a)(5) of this section such are moved interstate; (B) the destina- cattle when moved interstate are action of the animals; (C) the number of companied by a statement signed by animals covered by the statement or the owner or shipper of the cattle, or 2 Other document means a shipping permit, 1 Department-approved backtags are avail- an official health certificate, an official able at recognized slaughtering establish- brand inspection certificate, a bill of lading, ments and specifically approved stockyards a waybill, or an invoice on which is listed and from State representatives and APHIS the required information. representatives. A list of recognized slaugh- 3 Posted stockyards are designated by post- tering establishments and specifically ap- ing notice at such stockyards and by publi- proved stockyards may be obtained as indi- cation in the FEDERAL REGISTER. Informa- cated in § 78.1 of this chapter. The terms tion concerning posted stockyards may also ‘‘State representative’’ and ‘‘APHIS rep- be obtained from the Washington office or resentative’’ are defined in § 78.1 of this chap- the area offices of the Packers and Stock- ter. yards Administration.

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other document; and (D) the name and purebred animals which are moved in address of the owner at the time of interstate commerce for any purpose movement; (E) the name and address of other than slaughter and are identified the previous owner if ownership in a manner acceptable to the appro- changed within four months prior to priate breed association for registra- the movement of the cattle; and (F) the tion purposes; or are identified by a name and address of the shipper: Pro- brand registered with an official brand vided, That the application of backtags inspection agency and are accompanied is not required if such cattle are moved by an official brand inspection certifi- in interstate commerce to a recognized cate as prescribed in paragraph slaughtering establishment as defined (a)(1)(ii) of this section. in § 78.1 of this chapter and if, when (2) The owner’s or shipper’s state- moved in interstate commerce, such ment or other document 2 or registered cattle are identified by a brand reg- purebred identification required by istered with an official brand inspec- this section for cattle moved under tion agency and are accompanied by an paragraph (a)(1)(i) or (ii) of this section official brand inspection certificate: shall be delivered to the management And provided, further, That the applica- of the stockyard or slaughtering estab- tion of backtags is not required when lishment at the time of delivery of the such cattle are moved in interstate cattle; 5 and documents accompanying commerce to a recognized slaughtering animals moved under paragraph establishment as defined in § 78.1 of this (a)(1)(iii) of this section for breeding or chapter, which maintains records of dairy purposes shall be delivered to the ownership of cattle by slaughter lot consignee. All such documents shall be number; 4 or made available for inspection on re- (iii) May be moved in interstate com- quest by a State or Federal representa- merce for any purpose other than tive or an accredited veterinarian, as slaughter if such cattle, when moved in defined in § 78.1, at any time within the interstate commerce, are identified by year from the date of such delivery. Animal and Plant Health Inspection (3) Each person who ships, transports, Service-approved eartags in lieu of or otherwise causes the cattle to be backtags, and, except as provided in moved in interstate commerce is re- paragraph (a)(5) of this section, are ac- sponsible for the identification of the companied when moved interstate by cattle as required by this section. an owner’s statement or other docu- (4) No person shall remove or tamper ment 2 stating: (A) The point from with or cause the removal of or tam- which the animals are moved inter- pering with a backtag, eartag, brand, state, (B) the destination of the ani- or other identification device required mals, (C) the number of animals cov- to be on cattle pursuant to this section ered by the statement or other docu- while such cattle are being moved in ment, (D) the identifying numbers of interstate commerce, except at the the eartags, and (E) the name and ad- time of slaughter, or as may be author- dress of the owner at the time of move- ized by the Administrator, upon re- ment; (F) the name and address of the quest in specific cases and under such previous owner if ownership changed conditions as the Administrator, may within four months prior to the move- impose to ensure continuing identifica- ment of the cattle; and (G) the name tion. and address of the shipper: Provided, (5) Cattle that would otherwise be re- That identification by eartag is not required to be accompanied by an owner- quired if such animals are registered shipper statement or other document 2 as a condition of movement in interstate commerce under paragraph (a)(1) 4 It is the responsibility of the person who causes the interstate movement to deter- of this section, shall not be required to mine whether the establishment maintains such records. As evidence that the establish- 5 The backtag or other identification num- ment does maintain such records such person bers should be included on the receiving doc- should obtain a statement to that effect ument of the stockyard or establishment for from the management of the establishment all such cattle identified by backtags or and retain it for a period of five years from other identification after arrival at such the date of shipment. stockyard or establishment.

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be accompanied by such an owner-ship- shall remain so identified while they per statement or other document 6 if are in interstate commerce. the following conditions are met: if the (3) Each person who buys or sells, for cattle are moved to a recognized his or her own account or as the agent slaughtering establishment as defined of the buyer or seller, transports, rein § 78.1 of this chapter or to a stock- ceives for transportation, offers for yard specifically approved under § 71.20; sale or transportation, or otherwise if the cattle are moved from a farm or handles swine in interstate commerce, other premises where the cattle to be is responsible for the identification of moved interstate have been kept for the swine as provided by this section. not less than four months prior to the (b) Means of swine identification ap- date of movement; and if such farm or proved by the Administrator are: other premises has not had on the (1) Official eartags, when used on any premises any cattle or bison from any swine; other premises within four months (2) United States Department of Ag- prior to the date of movement. riculture backtags, when used on swine (b) In lieu of the backtags, eartags, moving to slaughter; and brands referred to in this section, (3) Official swine tattoos, when used any other official identification device on swine moving to slaughter, when or method that is approved by the Ad- the use of the official swine tattoo has ministrator may also be used. been requested by a user or the State animal health official, and the Admin- [38 FR 22768, Aug. 24, 1973, as amended at 47 FR 55656, Dec. 13, 1982; 50 FR 45987, Nov. 6, istrator authorizes its use in writing 1985; 51 FR 32599, Sept. 12, 1986; 52 FR 2987, based on a determination that the tat- Jan. 30, 1987; 55 FR 11156, Mar. 27, 1990; 62 FR too will be retained and visible on the 27934, May 22, 1997; 68 FR 62226, Nov. 3, 2003; carcass of the swine after slaughter, so 69 FR 64649, Nov. 8, 2004] as to provide identification of the swine; § 71.19 Identification of swine in inter- (4) Tattoos of at least 4-characters state commerce. when used on swine moving to slaugh- (a)(1) Except as provided in para- ter, except sows and boars as provided graphs (c) and (g) of this section, no in § 78.33 of this chapter; swine may be sold, transported, re- (5) Ear notching when used on any ceived for transportation, or offered for swine, if the ear notching has been resale or transportation, in interstate corded in the book of record of a pure- commerce, unless each swine is identi- bred registry association; fied at whichever of the following (6) Tattoos on the ear or inner flank comes first: of any swine, if the tattoos have been (i) The point of first commingling of recorded in the book of record of a the swine in interstate commerce with swine registry association; swine from any other source; (7) For slaughter swine and feeder (ii) Upon unloading of the swine in swine, an eartag or tattoo bearing the interstate commerce at any livestock premises identification number as- market; signed by the State animal health offi- (iii) Upon transfer of ownership of cial to the premises on which the swine the swine in interstate commerce; or originated; and (iv) Upon arrival of the swine in (8) Any other official identification interstate commerce at their final des- device or method that is approved by tination. the Administrator. (2) The identification shall be by (c) Swine that are kept as a group are means of identification approved by not required to be individually identi- the Administrator and listed in para- fied when in interstate commerce if: graph (b) of this section. All swine (1) They were born on the same premises; (2) They were raised on the same 6 Other document means a shipping permit, an official health certificate, an official premises where they were born; brand inspection certificate, a bill of lading, (3) They are moved in a group di- a waybill, or an invoice on which is listed rectly to a slaughtering establishment the required information. from the place where they were raised;

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(4) They are not mixed with swine (e)(1) Each person who buys or sells, from any other premises, between the for his or her own account or as the time they are born and the time they agent of the buyer or seller, transports, arrive at the slaughtering establish- receives for transportation, offers for ment; and sale or transportation, or otherwise (5) They are slaughtered one after an- handles swine in interstate commerce, other, as a group, and not mixed with must keep records relating to the other swine at slaughter; or approved transfer of ownership, shipment, or identification is applied to the swine handling of the swine, such as yarding after entry into the slaughtering estab- receipts, sale tickets, invoices, and lishment. waybills upon which is recorded: (d) Serial numbers of United States (i) All serial numbers and other ap- Department of Agriculture backtags proved means of identification appear- and official swine tattoos will be as- ing on the swine that are necessary to signed to each person who applies to identify it to the person from whom it the State animal health official or the was purchased or otherwise obtained; area veterinarian in charge for the and State in which that person maintains (ii) The street address, including city his/her or its place of business. Serial and state, or the township, county, and numbers of official eartags will be as- state, and the telephone number, if signed to each accredited veterinarian available, of the person from whom the or State or Federal representative who swine were purchased or otherwise ob- requests official eartags from the State tained. animal health official or the area vet- (2) Each person required to keep erinarian in charge, whoever is respon- records under this paragraph must sible for issuing official eartags in that maintain the records at his/her or its State. Persons assigned serial numbers place of business for at least 2 years of United States Department of Agri- after the person has sold or otherwise culture backtags, official swine tat- disposed of the swine to another per- toos, and official eartags must: son, and for such further period as the (1) Record the following information Administrator may require by written on a document: notice to the person, for purposes of (i) All serial numbers applied to the any investigation or action involving swine; the swine identified in the records. The (ii) Any other serial numbers and ap- person shall make the records avail- proved identification appearing on the able for inspection and copying during swine that are needed to identify the ordinary business hours (8 a.m. to 5:30 swine to its previous owner and loca- p.m., Monday through Friday) by any tion; authorized employee of the United (iii) The street address, including the States Department of Agriculture, city and state, or the township, county, upon that employee’s request and pres- and state, of the premises where the entation of his or her official creden- approved means of identification were tials. applied; and (f) No person may remove or tamper (iv) The telephone number, if avail- with any approved means of identifica- able, of the person who owns or pos- tion required to be on swine pursuant sesses the swine. to this section while it is in interstate (2) Maintain these records at the per- commerce, except at the time of son’s place of business for 2 years; and slaughter as provided in 9 CFR (3) Make these records available for 309.16(e). inspection and copying during ordinary (g) Swine moving interstate within a business hours (8 a.m. to 5:30 p.m., swine production system. Swine moving Monday through Friday) upon request within a swine production system to by any authorized employee of the other than slaughter or a livestock United States Department of Agri- market are not required to be individ- culture, upon that employee’s request ually identified when moved in inter- and presentation of his or her official state commerce under the following credentials. conditions:

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(1) The swine may be moved inter- health officials access to the premises state only to another premises identi- upon request to inspect animals and re- fied in a valid swine production health view records. plan for that swine production system. (8) Once a month, each swine produc- (2) The swine production system tion system must send APHIS a writ- must operate under a valid swine pro- ten summary based on the interstate duction health plan, in which both the swine movement report data that sending and receiving States have shows how many animals were moved agreed to allow the movement. in the past month, the premises from (3) The swine must have been found which they were moved, and the prem- free from signs of any communicable ises to which they were moved. disease during the most recent inspec- (h) Cancellation of and withdrawal tion of the premises by the swine pro- from a swine production health plan. The duction system accredited veteri- following procedures apply to cancella- narian(s) within 30 days prior to move- tion of, or withdrawal from, a swine ment. production health plan: (4) Prior to the movement of any (1) A State animal health official swine, the producer(s) moving swine may cancel his or her State’s participa- must deliver the required interstate tion in a swine production health plan swine movement report to the fol- by giving written notice to all swine lowing individuals identified in the producers, APHIS representatives, ac- swine production health plan: credited veterinarians, and other State (i) The swine production system ac- animal health officials listed in the credited veterinarian for the premises plan. Withdrawal shall be effective from which the swine are to be moved, upon the date specified by the State and animal health official in the notice, (ii) The State animal health officials but for shipments in transit, with- for the sending and receiving States, drawal shall become effective 7 days and any other State employees des- after the date of such notice. Upon ignated by the State animal health officials. withdrawal of a State, the swine pro- (5) The receiving premises must not duction health plan may continue to commingle swine received from dif- operate among the other States and ferent premises in a manner that pre- parties signatory to the plan. vents identification of the premises (2) A swine production system may that sent the swine or groups of swine. withdraw one or more of its premises This may be achieved by use of perma- from participation in the plan upon nent premises or individual identifica- giving written notice to the Adminis- tion marks on animals, by keeping trator, the accredited veterinarian(s), groups of animals received from one all swine producers listed in the plan, premises physically separate from ani- and State animal health officials listed mals received from other premises, or in the plan. Withdrawal shall be effec- by any other effective means. tive upon the date specified by the (6) Each premises must maintain, for swine production system in the written 3 years after their date of creation, notice, but for shipments in transit, records that will allow an APHIS rep- withdrawal shall become effective 7 resentative or State animal health offi- days after the date of such notice. cial to trace any animal on the prem- (3) The Administrator may cancel a ises back to its previous premises, and swine production health plan by giving must maintain copies of each swine written notice to all swine producers, production health plan signed by the accredited veterinarians, and State producer, all interstate swine move- animal health officials listed in the ment reports issued by the producer, plan. The Administrator shall cancel a and all reports the swine production swine production health plan after de- system accredited veterinarian(s) issue termining that swine movements with- documenting the health status of the in the swine production system have swine on the premises. occurred that were not in compliance (7) Each premises must allow APHIS with the swine production health plan representatives and State animal or with other requirements of this

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chapter. Before a swine health produc- for the day-to-day operations of the tion plan is canceled, an APHIS rep- livestock facility shall execute the fol- resentative will inform a representa- lowing agreement: tive of the swine production system of AGREEMENT—APPROVED LIVESTOCK the reasons for the proposed cancella- FACILITY FOR HANDLING LIVESTOCK tion. The swine production system may PURSUANT TO TITLE 9 OF THE CODE appeal the proposed cancellation in OF FEDERAL REGULATIONS writing to the Administrator within 10 [Name of facility] days after being informed of the rea- [Address and telephone number of facility] sons for the proposed cancellation. The I, [name of the individual legally responsible appeal must include all of the facts and for the day-to-day operations of the livestock reasons upon which the swine produc- facility], operator of [name of facility], hereby tion system relies to show that the rea- agree to maintain and operate the livestock sons for the proposed cancellation are facility located at [address of premises] in ac- incorrect or do not support the can- cordance with the applicable provisions of this agreement and Chapter I, Title 9, of the cellation. The Administrator will grant Code of Federal Regulations (9 CFR). or deny the appeal in writing as promptly as circumstances permit, Cooperation stating the reason for his or her deci- (1) The State animal health official and sion. If there is a conflict as to any ma- the area veterinarian in charge shall be pro- terial fact, a hearing will be held to re- vided with a schedule of the facility’s sale solve the conflict. Rules of practice days, which shall indicate the types of ani- concerning the hearing will be adopted mals that will be handled at the facility on by the Administrator. However, can- each sale day, and shall be apprised of any changes to that schedule prior to the imple- cellation of the disputed swine produc- mentation of the changes. tion health plan shall become effective (2) An accredited veterinarian, State rep- pending final determination in the pro- resentative, or APHIS representative shall ceeding if the Administrator deter- be on the facility premises on all sale days to mines that such action is necessary to perform duties in accordance with State and protect the public’s health, interest, or Federal regulations. safety. Such cancellation shall become (3) State representatives and APHIS representatives shall be granted access to the effective upon oral or written notifica- facility during normal business hours to tion, whichever is earlier, to the swine evaluate whether the facility and its oper- production system representative. In ations are in compliance with the applicable the event of oral notification, written provisions of this agreement and 9 CFR parts confirmation shall be given as prompt- 71, 75, 78, 79, and 85. ly as circumstances allow. This can- (4) An APHIS representative, State rep- cellation shall continue in effect pend- resentative, or accredited veterinarian shall ing the completion of the proceeding, be immediately notified of the presence at the facility of any livestock that are known and any judicial review thereof, unless to be infected, exposed, high-risk and otherwise ordered by the Adminis- scrapie-positive or suspect, or that show trator. signs of possibly being infected, with any infectious, contagious, or communicable dis- [53 FR 40385, Oct. 14, 1988, as amended at 55 ease. FR 11156, Mar. 27, 1990; 55 FR 15320, Apr. 23, (5) Any reactor, suspect, exposed, high- 1990; 59 FR 67612, Dec. 30, 1994; 62 FR 27934, risk, or scrapie positive livestock shall be May 22, 1997; 62 FR 54758, Oct. 22, 1997; 66 FR held in quarantined pens apart from all other 65603, Dec. 20, 2001; 69 FR 64649, Nov. 8, 2004; livestock at the facility. This requirement 74 FR 14709, Apr. 1, 2009] shall not apply to scrapie-exposed sheep that are not also designated high-risk animals or § 71.20 Approval of livestock facilities. to sheep or goats designated under 9 CFR (a) To qualify for approval by the Ad- part 79 as scrapie-exposed or high-risk ani- ministrator as an approved livestock mals that either are not pregnant based on facility 7 and to retain such designa- the animal being male, an owner certifi- tion, the individual legally responsible cation that any female animals have not been exposed to a male in the preceding 6 months, or a certificate issued by an accred- 7 A list of approved livestock facilities may ited veterinarian stating the animals are be obtained by writing to National Animal open; or that the animals are under 12 Health Programs, VS, APHIS, 4700 River months of age and are not visibly pregnant Road Unit 36, Riverdale, MD 20737–1231. and are maintained in the same pen only

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with other animals that will be moved di- or discharges may have contact shall be con- rectly to slaughter or to a terminal feedlot structed of materials that are substantially in accordance with 9 CFR parts 71 and 79. impervious to moisture and able to with- (6) No reactor, suspect, exposed, high-risk, stand continued cleaning and disinfection. or scrapie-positive livestock, nor any live- (13) Electrical outlets shall be provided at stock that show signs of being infected with the chute area for branding purposes. any infectious, contagious, or communicable disease, may be sold at or moved from the fa- Standards for Handling Different Classes of cility, except in accordance with 9 CFR parts Livestock 71, 75, 78, 79, and 85. (By his or her initials, the operator of the facility shall signify the class or classes of Records livestock that the facility will handle.) (7) Documents such as weight tickets, sales (14) Cattle and bison: slips, and records of origin, identification, —This facility will handle cattle and bison: and destination that relate to livestock that [Initials of operator, date] are in, or that have been in, the facility shall —This facility will handle cattle and bison be maintained by the facility for a period of known to be brucellosis reactors, suspects, 2 years, or for a period of 5 years in the case or exposed: [Initials of operator, date] of sheep or goats. APHIS representatives and —This facility will not handle cattle and State representatives shall be permitted to bison known to be brucellosis reactors, review and copy those documents during nor- suspects, or exposed and such cattle and mal business hours. bison will not be permitted to enter the facility: [Initials of operator, date] Identification (i) Cattle and bison shall be received, han- (8) All livestock must be officially identi- dled, and released by the facility only in ac- fied in accordance with the applicable regu- cordance with 9 CFR parts 71 and 78. lations in 9 CFR parts 71, 75, 78, 79, and 85 at (ii) All brucellosis reactor, brucellosis sus- the time of, or prior to, entry into the facil- pect, and brucellosis exposed cattle or bison ity. arriving at the facility shall be placed in quarantined pens and consigned from the fa- Cleaning and Disinfection cility only in accordance with 9 CFR part 78. (iii) Any cattle or bison classified as bru- (9) The facility, including all yards, docks, cellosis reactors at the facility shall be iden- pens, alleys, sale rings, chutes, scales, means tified in accordance with 9 CFR part 78, of conveyance, and their associated equip- placed in quarantined pens, and consigned ment, shall be maintained in a clean and from the facility only to a recognized slaugh- sanitary condition. The operator of the facil- tering establishment or an approved inter- ity shall be responsible for the cleaning and mediate handling facility in accordance with disinfection of the facility in accordance 9 CFR part 78. with 9 CFR part 71 and for maintaining an (iv) Any cattle or bison classified as bru- adequate supply of disinfectant and service- cellosis exposed at the facility shall be iden- able equipment for cleaning and disinfection. tified in accordance with 9 CFR part 78, General Facilities and Equipment Standards placed in quarantined pens, and consigned from the facility only to a recognized slaugh- (10) All facilities and equipment shall be tering establishment, approved intermediate maintained in a state of good repair. The fa- handling facility, quarantined feedlot, or cility shall contain well-constructed and farm of origin in accordance with 9 CFR part well-lighted livestock handling chutes, pens, 78. alleys, and sales rings for the inspection, (v) The identity of cattle from Class Free identification, vaccination, testing, and States or areas and Class A States or areas branding of livestock. shall be maintained. (11) Quarantined pens shall be clearly la- (vi) The identity of cattle from Class B beled with paint or placarded with the word States or areas shall be maintained, and ‘‘Quarantined’’ or the name of the disease of test-eligible cattle from Class B States or concern, and shall be cleaned and disinfected areas shall not be placed in pens with cattle in accordance with 9 CFR part 71 as well as from any other area until they have fulfilled 9 CFR 54.7(e)(2) if the disease of concern is the requirements of 9 CFR part 78 for release scrapie and the quarantined animal gave from the facility. birth or aborted at the facility, before being (vii) The identity of cattle from Class C used to pen livestock that are not reactor, States or areas shall be maintained, and suspect, exposed, high-risk, or scrapie-posi- test-eligible cattle from Class C States or tive animals. areas shall not be placed in pens with cattle (12) Quarantined pens shall have adequate from any other area until they have fulfilled drainage, and the floors and those parts of the requirements of 9 CFR part 78 for release the walls of the quarantined pens with which from the facility. reactor, suspect, exposed, high-risk, or (viii) The identity of cattle from quar- scrapie-positive livestock, their excrement, antined areas shall be maintained, and test-

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eligible cattle from quarantined areas shall —This facility will handle horses: [Initials of not be placed in pens with cattle from any operator, date] other area until they have fulfilled the re- —This facility will handle equine infectious quirements of 9 CFR part 78 for release from anemia (EIA) reactors: [Initials of operator, the facility. date] (ix) Test-eligible cattle that are penned —This facility will not handle horses known with test-eligible cattle from a lower class to be EIA reactors and will not permit EIA State or area, in violation of this agreement, reactors to enter the facility: [Initials of shall have the status of the State or area of operator, date] lower class for any subsequent movement. (i) Horses shall be received, handled, and (x) Laboratory space shall be furnished and released by the livestock facility only in ac- maintained for conducting diagnostic tests. cordance with 9 CFR parts 71 and 75. All test reagents, testing equipment, and (ii) Any horses classified as EIA reactors documents relating to the State-Federal co- and accepted by the facility for sale shall be operative eradication programs on the facili- placed in quarantined pens at least 200 yards ty’s premises shall be secured to prevent from all non-EIA-reactor horses. misuse and theft. Adequate heat, cooling, (iii) Any horses classified as EIA reactors electricity, water piped to a properly drained and accepted by the facility for sale shall be sink, and sanitation shall be provided for consigned from the facility only to a slaugh- properly conducting diagnostic tests. tering establishment or to the home farm of (15) Swine: the reactor in accordance with 9 CFR part 75. —This facility will handle breeding swine: (iv) Fly Control Program: The livestock fa- [Initials of operator, date] cility shall have in effect a fly control pro- —This facility will handle slaughter swine: gram utilizing at least one of the following: [Initials of operator, date] Baits, fly strips, electric bug killers (‘‘Fly —This facility will handle feeder swine: Zappers,’’ ‘‘Fly Snappers,’’ or similar equip- [Initials of operator, date] ment), or the application of a pesticide effec- —This facility will handle pseudorabies reac- tive against flies, applied according to the tor, suspect, or exposed swine: [Initials of schedule and dosage recommended by the operator, date]. manufacturer for fly control. —This facility will not handle swine known (17) Sheep and goats: to be pseudorabies reactor, suspect, or ex- —This facility will handle breeding sheep or posed swine and such swine will not be per- goats: [Initials of operator, date] mitted to enter the facility: [Initials of op- —This facility will handle slaughter sheep or erator, date]. goats: [Initials of operator, date] (i) Swine shall be received, handled, and re- —This facility will handle scrapie-exposed leased by the livestock facility only in ac- goats or high-risk sheep or goats: [Initials cordance with 9 CFR parts 71, 78, and 85. of operator, date] (ii) Pens, alleys, and sales rings for hold- —This facility will not handle goats known ing, inspecting, and otherwise handling to be scrapie-exposed or sheep or goats swine shall be imperviously surfaced. known to be high-risk animals, nor permit (iii) Slaughter swine may be handled only such animals to enter the facility: [Initials on days when no feeder swine or breeder of operator, date] swine are present at the facility, unless the (i) All sheep and goats must be received, facility has provisions to keep slaughter handled, and released by the facility only in swine physically separated from feeder swine accordance with 9 CFR parts 71 and 79. and breeder swine or unless those areas of (ii) All sheep and goats at the facility must the facility used by slaughter swine have be officially identified and relevant records been cleaned and disinfected before being related to those identified animals must be used by feeder swine or breeder swine. maintained by the facility operator, as re- (iv) No feeder swine or breeder swine may quired under 9 CFR part 79. remain in the livestock facility for more (iii) The identity of sheep and goats from than 72 hours, and no slaughter swine may consistent States and inconsistent States remain in the livestock market for more must be maintained by the facility operator. than 120 hours. (iv) Sexually intact animals that do not (v) Feeder swine shall be kept separate and meet the requirements of part 79 to be sold apart from other swine while in the livestock as breeding animals must be maintained in facility. separated enclosures at all times from ani- (vi) No release shall be issued for the re- mals that may be offered for sale as breeding moval of slaughter swine from the livestock animals unless all animals maintained in an facility unless the slaughter swine are con- enclosure arrived at the facility as part of signed for immediate slaughter or to another the same consignment and are separated slaughter market and the consignee is iden- prior to sale. tified on the release document. (v) Any sheep or goats that are designated, (16) Horses: with regard to scrapie, as high-risk, suspect

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or scrapie-positive animals, and goats des- concerning the hearing will be adopted ignated with regard to scrapie as exposed by the Administrator. animals, excluding slaughter sheep or goats (2) In the case of withdrawal, before that are designated as exposed or high-risk animals and are not pregnant, must be held such action is taken, the operator of in quarantined pens while at the facility. the facility will be informed of the reasons for the proposed withdrawal. The Approvals operator of the facility may appeal the (18) Request for approval: proposed withdrawal in writing to the I hereby request approval for this facility Administrator within 10 days after to operate as an approved livestock facility being informed of the reasons for the for the classes of livestock indicated in paragraphs (14) through (17) of this agreement. I proposed withdrawal. The appeal must acknowledge that I have received a copy of 9 include all of the facts and reasons CFR parts 71, 75, 78, 79, and 85, and acknowl- upon which the person relies to show edge that I have been informed and under- that the reasons for the proposed withstand that failure to abide by the provisions drawal are incorrect or do not support of this agreement and the applicable provi- the withdrawal of the approval of the sions of 9 CFR parts 71, 75, 78, 79, and 85 constitutes a basis for the withdrawal of this ap- livestock facility to receive livestock proval. [Printed name and signature of oper- moved interstate under this sub- ator, date of signature] chapter. The Administrator will grant (19) Pre-approval inspection of livestock or deny the appeal in writing as facility conducted by [printed name and title promptly as circumstances permit, of APHIS representative] on [date of inspection]. stating the reason for his or her deci- (20) Recommend approval: [Printed name and signature of State animal sion. If there is a conflict as to any ma- health official, date of signature] terial fact, a hearing will be held to re- [Printed name and signature of area veteri- solve the conflict. Rules of practice narian in charge, date of signature] concerning the hearing will be adopted (21) Approval granted: by the Administrator. However, with- [Printed name and signature of the Adminis- drawal shall become effective pending trator, Animal and Plant Health Inspection Service, date of signature] final determination in the proceeding when the Administrator determines (b) Denial and withdrawal of approval. that such action is necessary to pro- The Administrator may deny or with- tect the public health, interest, or safe- draw the approval of a livestock facil- ty. Such withdrawal shall be effective ity to receive livestock moved inter- upon oral or written notification, state under this subchapter upon a de- whichever is earlier, to the operator of termination that the livestock facility is not or has not been maintained and the facility. In the event of oral notifi- operated in accordance with the agree- cation, written confirmation shall be ment set forth in paragraph (a) of this given as promptly as circumstances section. allow. This withdrawal shall continue (1) In the case of a denial, the oper- in effect pending the completion of the ator of the facility will be informed of proceeding, and any judicial review the reasons for the denial and may ap- thereof, unless otherwise ordered by peal the decision in writing to the Ad- the Administrator. ministrator within 10 days after receiv- (3) Approval for a livestock facility ing notification of the denial. The ap- to handle livestock under this sub- peal must include all of the facts and chapter will be automatically with- reasons upon which the person relies to drawn by the Administrator when: show that the livestock facility was (i) The operator of the facility noti- wrongfully denied approval to receive fies the Administrator, in writing, that livestock moved interstate under this the facility no longer handles livestock subchapter. The Administrator will moved interstate under this sub- grant or deny the appeal in writing as chapter; or promptly as circumstances permit, (ii) The person who signed the agree- stating the reason for his or her deci- ment executed in accordance with sion. If there is a conflict as to any material fact, a hearing will be held to re- paragraph (a) of this section is no solve the conflict. Rules of practice

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longer responsible for the day-to-day their facility for blood and tissue sam- operations of the facility. ple collection; (2) The establishment allows APHIS, (Approved by the Office of Management and FSIS, or APHIS contractors to take Budget under control number 0579–0258) blood and tissue samples from all live- [62 FR 27934, May 22, 1997, as amended at 62 stock or poultry at the facility without FR 54758, Oct. 22, 1997; 63 FR 32119, June 12, cost to the United States, and specifi- 1998; 68 FR 62226, Nov. 3, 2003; 74 FR 14709, cally allows these personnel access to Apr. 1, 2009] the processing line to collect samples; and § 71.21 Tissue and blood testing at (3) The establishment allows APHIS, slaughter. FSIS, or APHIS contractors to record (a) Any person moving livestock or the identification of individual animals poultry interstate for slaughter or ren- and retain any external or internal dering may only move the animals to a identification devices. slaughtering establishment or a ren- (b) The establishment must provide dering establishment that has been office and sample collection space, in- listed by the Administrator 8 for the cluding necessary furnishings, light, purposes of this part. Livestock or heat, and janitor service, rent free, for poultry may not be removed from the the use by APHIS, FSIS, or APHIS premises of a slaughtering establish- contractors collecting samples for ment or a rendering establishment list- blood and tissue testing under this sec- ed by the Administrator except under a tion. The Administrator will inform permit issued by APHIS, and in accord- each establishment of the exact ance with applicable FSIS regulations amount and type of space required, in this title. A slaughtering establish- taking into account whether APHIS ment or rendering establishment may will be conducting complete tests at receive livestock or poultry in inter- the facility, or only collecting samples state commerce only if the establish- and sending them elsewhere for test- ment has been listed by the Adminis- ing. At the discretion of the Adminis- trator. The Administrator may list a trator, small plants need not furnish slaughtering establishment or a ren- facilities as prescribed in this section if dering establishment after determining adequate facilities exist in a nearby that collecting samples for testing convenient location. In granting or de- from the establishment is not cur- nying listing of an establishment, the rently necessary for the purposes of Administrator will consider whether APHIS disease surveillance programs the space at the facility: and the establishment has agreed to (1) Is conveniently located, properly allow testing and to provide the access ventilated, and provided with lockers and facilities required by this section suitable for the protection and storage upon future APHIS notification that of supplies; testing is required at the establish- (2) Has sufficient light to be adequate ment. The Administrator will list a for proper conduct of sample collection slaughtering or rendering establish- and processing; ment after determining that it meets (3) Includes racks, receptacles, or the following facility and access re- other suitable devices for retaining quirements: such parts as the head, glands, and (1) The establishment provides space viscera, and all parts and blood to be and equipment in accordance with collected, until after the post-mortem examination is completed; paragraph (b) of this section 9 within (4) Includes tables, benches, and other equipment on which sample col- 8 A list of these slaughtering or rendering lection and processing are to be per- establishments may be obtained by writing formed, of such design, material, and to National Center for Animal Health Pro- construction as to enable sample col- grams, VS, APHIS, 4700 River Road Unit 43, Riverdale, MD 20737–1231. lection and processing in a safe, ready, 9 FSIS also has equipment and space re- efficient, and clean manner; quirements for official establishments at (5) Has adequate arrangements, in- § 307.2(c) of this title. cluding liquid soap and cleansers, for

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cleansing and disinfecting hands, dis- drawal. The operator of the establish- section tools, floors, and other articles ment may appeal the proposed with- and places that may be contaminated drawal in writing to the Administrator by diseased carcasses or otherwise; and within 10 days after being informed of (6) Has adequate facilities, including the reasons for the proposed with- denaturing materials, for the proper drawal. The appeal must include all of disposal in accordance with this chap- the facts and reasons upon which the ter of tissue, blood, and other waste person relies to show that the reasons generated during test sample collec- for the proposed withdrawal are incor- tion. rect or do not support the withdrawal (c) The Administrator will give the of the listing. The Administrator will operator of the establishment actual grant or deny the appeal in writing as notice that APHIS, FSIS, or an APHIS promptly as circumstances permit, contractor will be taking blood and/or stating the reason for his or her deci- tissue samples at the establishment. sion. If there is a conflict as to any ma- The Administrator may give the oper- terial fact, a hearing will be held to re- ator of the establishment notice in any solve the conflict. Rules of practice form or by any means that the Admin- concerning the hearing will be adopted istrator reasonably believes will reach by the Administrator. However, with- the operator of the establishment prior drawal shall become effective pending to the start of sample collection. final determination in the proceeding (1) The notice will include the antici- when the Administrator determines pated date and time sample collection that such action is necessary to pro- will begin. The notice will also include tect the public health, interest, or safe- the anticipated ending date and time. ty. Such withdrawal shall be effective (2) The Administrator will give the upon oral or written notification, operator of the establishment as much whichever is earlier, to the operator of advance notice as possible. However, the establishment. In the event of oral the actual amount of notice will de- notification, written confirmation pend on the specific situation. shall be given as promptly as cir- (d) Denial and withdrawal of listing. cumstances allow. This withdrawal The Administrator may deny or with- shall continue in effect pending the draw the listing of an establishment completion of the proceeding, and any upon a determination that the estab- judicial review thereof, unless other- lishment is not in compliance with the wise ordered by the Administrator. requirements of this section. (Approved by the Office of Management and (1) In the case of a denial, the oper- Budget under control number 0579–0212) ator of the establishment will be in- [69 FR 10150, Mar. 4, 2004] formed of the reasons for the denial and may appeal the decision in writing § 71.22 Removal and loss of official to the Administrator within 10 days identification devices. after receiving notification of the de- Official identification devices are in- nial. The appeal must include all of the tended to provide permanent identi- facts and reasons upon which the per- fication of livestock and to ensure the son relies to show that the establish- ability to find the source of animal dis- ment was wrongfully denied listing. ease outbreaks. Removal of these de- The Administrator will grant or deny vices, including devices applied to im- the appeal in writing as promptly as ported animals in their countries of or- circumstances permit, stating the rea- igin and recognized by the Adminis- son for his or her decision. If there is a trator as official, is prohibited except conflict as to any material fact, a hear- at the time of slaughter. If an official ing will be held to resolve the conflict. identification device is lost and it is Rules of practice concerning the hear- necessary to retag an animal with a ing will be adopted by the Adminis- new official number, every effort trator. should be made to correlate the new of- (2) In the case of withdrawal, before ficial number with the previous official such action is taken, the operator of number of the animal. If an official the establishment will be informed of identification device applied to an im- the reasons for the proposed with- ported animal in its country of origin

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is lost following importation into the 72.19 Interstate shipments and use of pine United States, the animal may only be straw, grass, litter from quarantined retagged with an official identification area; prohibited until disinfected. device using a numbering system other 72.20 Exhibition of noninfected cattle in the quarantined area; restrictions under than an animal identification number which permitted. beginning with the 840 prefix. 72.21 Animals infested with or exposed to [73 FR 54062, Sept. 18, 2008] ticks subject to same restrictions as cattle. 72.22 Cars, vehicles, and premises; cleaning PART 72—TEXAS (SPLENETIC) FEVER and treatment after containing infested IN CATTLE or exposed animals. 72.23 Cars or other vehicles having carried Sec. infested or exposed cattle in quarantined 72.1 Ticks [Boophilus annulatus area shall be cleaned and treated. (Margaropus annulatus), Boophilus 72.24 Litter and manure from carriers and microplus, or Rhipicephalus evertsi premises of tick-infested animals; de- evertsi]; interstate movement of infested struction or treating required. or exposed animals prohibited. 72.25 Dipping methods. 72.2 Splenetic or tick fever in cattle in AUTHORITY: 7 U.S.C. 8301–8317; 7 CFR 2.22, Texas, the Virgin Islands of the United 2.80, and 371.4. States and vectors of said disease in the Northern Mariana Islands, the Common- SOURCE: 28 FR 5940, June 13, 1963, unless wealth of Puerto Rico and the Island of otherwise noted. Guam: Restrictions on movement of cattle. § 72.1 Ticks [Boophilus annulatus 72.3 Areas quarantined in the Virgin Islands (Margaropus annulatus), Boophilus of the United States, the Northern Mar- microplus, or Rhipicephalus evertsi iana Islands, the Commonwealth of Puer- evertsi]; interstate movement of in- to Rico, and the Island of Guam. fested or exposed animals prohib- 72.4 [Reserved] ited. 72.5 Area quarantined in Texas. No animals infested with ticks 72.6 Interstate movement of cattle from [Boophilus annulatus (Margaropus quarantined areas not eradicating ticks. 72.7 Interstate movement of cattle from co- annulatus), Boophilus microplus, or operating States. Rhipicephalus evertsi evertsi] or ex- 72.8 Interstate movement of cattle from posed to tick infestation shall be free premises upon inspection and certifi- shipped, trailed, driven, or otherwise cation by APHIS inspector. moved interstate for any purpose, ex- 72.9 Interstate movements of cattle; inspec- cept as provided in this part. tion and certification by APHIS inspector required. § 72.2 Splenetic or tick fever in cattle 72.10 Inspected or dipped and certified cat- in Texas, the Virgin Islands of the tle subject to restrictions of State of des- United States and vectors of said tination. disease in the Northern Mariana Is- 72.11 Quarantined area; cattle considered lands, the Commonwealth of Puerto infested; requirements for placing in non- Rico and the Island of Guam: Re- infectious pens or premises. strictions on movement of cattle. 72.12 Cattle; exposure to tick infestation after treatment or inspection prohibited. Notice is hereby given that the con- 72.13 Permitted dips and procedures. tagious, infectious, and communicable 72.14 [Reserved] disease known as splenetic or tick 72.15 Owners assume responsibility; must fever exists in cattle in portions of the execute agreement prior to dipping or State of Texas and the Virgin Islands treatment waiving all claims against United States. of the United States. Notice is also 72.16 Designated dipping stations to be ap- hereby given that ticks which are vec- proved by the Administrator, APHIS on tors of said disease exist in the North- recommendations of State authorities; ern Mariana Islands, the Common- facilities. wealth of Puerto Rico, and the Island 72.17 Unloading noninfected cattle for rest, of Guam. Therefore, portions of the feed, and water only, permitted in au- State of Texas, the Virgin Islands of thorized pens for such purpose. 72.18 Movement interstate; specification by the United States, the Northern Mar- the Deputy Administrator, Veterinary iana Islands, the Commonwealth of Services of treatment required when dip- Puerto Rico and the Island of Guam ping facilities unavailable. are hereby quarantined as provided in

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§§ 72.3 and 72.5, and the movement of § 72.6 Interstate movement of cattle cattle therefrom into any other State from quarantined areas not eradi- or Territory or the District of Colum- cating ticks. bia shall be made only in accordance Cattle in quarantined areas where with the provisions of this part and tick eradication is not being con- part 71 of this chapter. ducted 3 may be shipped or transported [43 FR 60864, Dec. 29, 1978] interstate in accordance with §§ 72.9 through 72.15 under the following con- § 72.3 Areas quarantined in the Virgin ditions: The cattle must have been Islands of the United States, the dipped twice with a permitted dip as Northern Mariana Islands, the Com- provided in § 72.13, with an interval of 7 monwealth of Puerto Rico, and the to 12 days between dippings imme- Island of Guam. diately preceding shipment, at a des- The entire Territories of the Virgin ignated dipping station approved under Islands of the United States and the Is- § 72.16 and located in the State of origin land of Guam, the Northern Mariana of the shipment or, in specific cases, Islands, and the Commonwealth of after having been otherwise treated at Puerto Rico are quarantined. a designated dipping station under the supervision of an APHIS inspector and [43 FR 60864, Dec. 29, 1978] in a manner approved by the Adminis- trator. In all cases, the cattle must be § 72.4 [Reserved] inspected by an APHIS inspector just § 72.5 Area quarantined in Texas. prior to final dipping, found to be apparently free of ticks, and be certified The area quarantined in Texas is the as such by APHIS before the cattle quarantined area described in the regu- may be released for interstate move- lations of the Texas Animal Health ment. Commission (TAHC) contained in §§ 41.14 through 41.22 of title 4, part II, [66 FR 21061, Apr. 27, 2001] of the Texas Administrative Code (4 TAC 41.14 through 41.22), effective June § 72.7 Interstate movement of cattle from cooperating States. 23, 2002, which is incorporated by reference. This incorporation by reference Cattle in areas where tick eradi- was approved by the Director of the cation is being conducted in coopera- Federal Register in accordance with 5 tion with State authorities, 3 which on U.S.C. 552(a) and 1 CFR part 51. Copies inspection by an APHIS inspector are of 4 TAC 41.14 through 41.22 may be ob- found to be apparently free from ticks, tained from the TAHC at 2105 Kramer may, after one dipping, with a per- Lane, Austin, TX 78758, and from area mitted dip as provided in § 72.13, under offices of the TAHC, which are listed in the supervision of an APHIS inspector local Texas telephone directories. The and certification by the inspector, be TAHC also maintains a copy of its reg- shipped or transported interstate for ulations on its Internet homepage at dip as provided in § 72.13, under the supervision of an APHIS inspector and http://www.tahc.state.tx.us/. Copies may certification by the inspector, be be inspected at the Animal and Plant shipped or transported interstate for Health Inspection Service, Veterinary any purpose upon compliance with the Services, suite 3B08, 4700 River Road, requirements set forth in §§ 72.9 Riverdale, MD, or at the National Ar- through 72.15. chives and Records Administration (NARA). For information on the avail- [36 FR 20358, Oct. 21, 1971, as amended at 56 ability of this material at NARA, call FR 51975, Oct. 17, 1991] 202–741–6030, or go to: http:// www.archives.gov/federallregister/ 3 Information regarding the identities of codeloflfederallregulations/ such areas may be obtained from the Animal ibrllocations.html. and Plant Health Inspection Service, Veteri- nary Services, National Animal Health Pro- [69 FR 8329, Feb. 24, 2004, as amended at 69 grams, 4700 River Road Unit 43, Riverdale, FR 18803, Apr. 9, 2004] Maryland 20737–1231.

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§ 72.8 Interstate movement of cattle § 72.11 Quarantined area; cattle con- from free premises upon inspection sidered infested; requirements for and certification by APHIS inspec- placing in noninfectious pens or tor. premises. Cattle located in areas where tick Cattle of the quarantined area shall eradication is being conducted in co- be considered infested and shall not be operation with the State authorities, placed in noninfectious pens or prem- and which are on premises shown by ises until after the final inspection or the official records of tick eradication dipping. to be free from ticks, may, upon inspection and certification by an APHIS § 72.12 Cattle; exposure to tick infesta- inspector, be shipped or transported tion after treatment or inspection interstate for any purpose without dip- prohibited. ping upon compliance with the require- The cattle shall not be exposed to ments set forth under §§ 72.9, 72.10, tick infestation after treatment and/or 72.12. inspection. [28 FR 5940, June 13, 1963, as amended at 56 FR 51975, Oct. 17, 1991] § 72.13 Permitted dips and procedures. (a) Dipping requirements; facilities; § 72.9 Interstate movements of cattle; handling. The dipping of cattle for inspection and certification by interstate movement shall be done APHIS inspector required. only with a permitted dip and at places All interstate movements of in- where proper equipment is provided for spected and certified and dipped and dipping and for handling the cattle in a certified cattle shall be accompanied to manner to prevent exposure to infec- final destination by a certificate of an tion after the final dipping. Cattle APHIS inspector (which certificate which are to be dipped shall be given shall show that the cattle so being an opportunity to drink sufficient moved have been dipped as required by water to quench their thirst prior to § 72.6 or by § 72.7 and are free of ticks, or dipping, be carefully handled, and not have been inspected as required by dipped while they are in a heated or ex- § 72.8 and are free of ticks); all such cer- hausted condition. Dipped cattle shall tificates shall be handled, delivered, not be loaded for shipment until dry. 4 kept, and preserved in accordance with (b) Permitted dips. The dips at present the provisions of § 72.16; and all such permitted by the Department in offi- cattle shall be handled through non- cial dipping for interstate movement infectious pens, alleys, and chutes, and are: when shipped shall be loaded into clean (1) Approved proprietary brands of a and disinfected cars or trucks, and Dioxathion (Delnav ®) emulsifiable con- shall not be unloaded in the quar- centrate used at a concentration of antined area except at such points re- 0.125 to 0.150 percent. 4 served for noninfested cattle as may (2) Approved proprietary brands of from time to time be authorized by coumaphos (Co-Ral ®), 25 percent wet- APHIS. table powder or flowable form labeled [28 FR 5940, June 13, 1963, as amended at 56 for use as a 0.25 percent dip and used at FR 51975, Oct. 17, 1991] a concentration of 0.125 to 0.250. 4

§ 72.10 Inspected or dipped and cer- 4 Care is required when treating animals tified cattle subject to restrictions and in maintaining the required concentra- of State of destination. tion of chemicals in dipping baths. Detailed All such interstate movements of in- information concerning the use of, criteria spected or dipped and certified cattle for, and names of proprietary brands of per- are subject to such restrictions, which mitted dips—as well the use of compressed are not inconsistent with the regula- air, vat management techniques, and other information—is available from the Animal tions in this subchapter, as may be im- and Plant Health Inspection Service, Veteri- posed at destination by the officials of nary Services, National Animal Health Pro- the State, Territory, or the District of grams, 4700 River Road Unit 43, Riverdale, Columbia. MD 20737–1231.

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(3) Approved proprietary brands of the cattle, offered for shipment, or his organophosphorous insecticides agent duly authorized thereto, shall (Prolate ®) if used in a Prolate-water first execute and deliver to an APHIS bath where the concentration level is inspector an application for inspection at least 0.15 percent and if used in ac- and supervised dipping wherein he shall cordance with the EPA approved label. agree to waive all claims against the (4) Approved proprietary brands of United States for any loss or damage organophosphorous insecticides to said cattle occasioned by or result- (Ciodrin ®) if used in a concentration of ing from dipping or other treatment 0.44 to 0.54 percent and if used in ac- under this part, or resulting from any cordance with the EPA approved label. subsequent treatment prior to their (c) Approval of dips. Proprietary interstate shipment, or resulting from brands of dips are permitted to be used the fact that they are later found to be for purposes of this part only when ap- still tick infested, and also for all sub- proved by the Administrator, APHIS. sequent loss or damage to any other Before a dip will be specifically ap- cattle in the possession or control of proved as a permitted dip for the eradi- such owner which may come into con- cation of ticks, APHIS will require tact with the cattle so dipped or treat- that the product be registered under ed. the provisions of the Federal Insecti- [28 FR 5940, June 13, 1963, as amended at 56 cide, Fungicide and Rodenticide Act, as FR 51975, Oct. 17, 1991] amended (7 U.S.C. 135 et seq.); that its efficacy and stability have been dem- § 72.16 Designated dipping stations to onstrated; that trials have been con- be approved by the Administrator, ducted to determine that its concentra- APHIS on recommendations of tion can be maintained and that under State authorities; facilities. actual field conditions the dipping of When deemed advisable and upon rec- cattle with a solution of definite ommendation by the proper livestock strength will effectually eradicate sanitary authorities, designated dip- ticks without injury to the animals ping stations may be approved by the dipped. Administrator, APHIS as points at (d) Tissue residues; restriction on which cattle of the quarantined area of slaughter. Tissue residues are created the State in which said station is lo- following use of certain dips. Animals cated may be inspected, dipped, and treated with such dips should not be certified for interstate movement. The slaughtered for food purposes until the facilities furnished shall include proper expiration of such period as may be re- dipping equipment, noninfectious pens quired under the Federal Meat Inspec- constructed in accordance with § 72.17 tion Act (21 U.S.C. 601 et seq.). The and a roofed or covered section of pens length of this period shall be specified of sufficient size to protect all dipped on each certificate issued by the in- animals from exposure to rain or hot spector who supervises the dipping. sun. All alleys, chutes, and pens shall be paved or properly floored. [33 FR 18089, Dec. 5, 1968, as amended at 34 FR 12214, July 24, 1969; 36 FR 19157, Sept. 30, [28 FR 5940, June 13, 1963, as amended at 50 1971; 36 FR 19972, Oct. 14, 1971; 37 FR 13529, FR 430, Jan. 4, 1985; 56 FR 51974, Oct. 17, 1991] July 11, 1972; 38 FR 19012, July 17, 1973; 40 FR 12768, Mar. 21, 1975; 42 FR 19854, Apr. 15, 1977; § 72.17 Unloading noninfected cattle 47 FR 11002, Mar. 15, 1982; 49 FR 19799, May 10, for rest, feed, and water only, per- 1984; 49 FR 32540, Aug. 15, 1984; 50 FR 430, 431, mitted in authorized pens for such Jan. 4, 1985; 56 FR 51974, Oct. 17, 1991; 66 FR purpose. 21062, Apr. 27, 2001] (a) Specifications for construction and § 72.14 [Reserved] maintenance. Cattle of the free area, and cattle of the quarantined area § 72.15 Owners assume responsibility; when properly dipped, inspected, and must execute agreement prior to certified in accordance with this part, dipping or treatment waiving all which are transported interstate by claims against United States. rail through the quarantined area shall When the cattle are to be dipped not be unloaded therein for rest, feed, under APHIS supervision the owner of and water unless they are unloaded

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into the properly equipped, noninfec- noninfectious pens shall be shipped in tious pens set apart for such cattle at noninfectious cars from points outside such points as may from time to time of the quarantined area so handled that be authorized by APHIS. Such non- they may not become infectious. infectious pens and the platforms, [28 FR 5940, June 13, 1963, as amended at 56 chutes, and alleys leading thereto shall FR 51975, Oct. 17, 1991] be constructed and maintained in accordance with the specifications set § 72.18 Movement interstate; specifica- out in paragraphs (a)(1) to (6) of this tion by the Deputy Administrator, section. Veterinary Services of treatment re- (1) The outside fences enclosing such quired when dipping facilities un- pens, and the fences on either side of available. the alleys, chutes, and platforms lead- (a) Tick-infested cattle. Cattle of the ing thereto, shall be tight board fences free area which are tick-infested may not less than 6 feet high on the inside. be moved interstate for any purpose (2) If such pens, alleys, chutes, and after they have been treated in the platforms are adjacent to pens, alleys, same manner as cattle under § 72.6: Pro- chutes, and platforms used by cattle of vided, however, That when dipping the quarantined area, there shall be be- equipment is not available at the place tween them a space not less than 10 where the cattle are, said treatment feet wide, which shall be inaccessible shall be given at a place and in the to livestock. This space shall be lim- manner specified by the Administrator, ited on each side by the 6–foot fence re- APHIS. quired by paragraph (a)(1) of this sec- (b) Tick-exposed cattle. Cattle of the tion. The remaining space around such free area which have been exposed to yards shall be limited as in paragraph tick infestation may be moved inter- (a)(3) of this section. state for any purpose after they have (3) If such pens, alleys, chutes, and been treated in the same manner as platforms are isolated from other pens, cattle under § 72.7: Provided, however, alleys, chutes, or platforms, there shall That when dipping equipment is not be built and maintained outside thereof available at the place where the cattle on all sides to which cattle of the vi- are, said treatment shall be given at a cinity might otherwise approach a cat- place and in the manner specified by tle-proof fence not less than 5 feet high the Administrator, APHIS. and not less than 15 feet from the 6– (c) Cattle moved contrary to regula- foot fence required by paragraph (a)(1) tions. Cattle which have been moved of this section. from the quarantined area to the free (4) The only means of egress from area without first having been treated such pens shall be by way of the alleys, in the manner provided in either § 72.6 chutes, and platforms inclosed by 6– or § 72.7 or inspected in the manner pro- foot fences as required by paragraph vided in § 72.8 shall not be shipped or (a)(1) of this section, to cars for refor- moved interstate until they have been warding; and under no circumstances treated in the same manner as cattle shall there exist any connection be- under § 72.6: Provided, however, That tween such pens and other adjacent when dipping equipment is not avail- premises. able at the place where the cattle are, (5) Such noninfectious premises shall said treatment shall be given at a place be so located, or such drainage facili- and in the manner specified by the Ad- ties shall be provided therefor, that ministrator, APHIS. water from the surrounding area will [28 FR 5940, June 13, 1963, as amended at 50 not flow on to or through them. FR 430, Jan. 4, 1985; 56 FR 51974, Oct. 17, 1991] (6) Such pens shall be marked by a conspicuous sign bearing the words § 72.19 Interstate shipments and use of ‘‘Noninfectious Pens’’ in letters not pine straw, grass, litter from quar- less than 10 inches in height. antined area; prohibited until dis- (b) Materials for use in noninfectious infected. pens; source, shipment, handling. The Pine straw, grass, or similar litter hay, straw, or similar materials re- collected from tick-infested pastures, quired for feed and bedding in such ranges, or premises may disseminate

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the contagion of splenetic, southern, or a State or Federal inspector or an ac- Texas fever; therefore pine straw, credited veterinarian. grass, or similar litter originating in the quarantined area shall not be [38 FR 21996, Aug. 15, 1973] transported or moved interstate there- § 72.23 Cars or other vehicles having from or used as packing material or car carried infested or exposed cattle in bedding for commodities or livestock quarantined area shall be cleaned to be transported or moved from the and treated. quarantined area of any State, Terri- tory, or the District of Columbia, to or Cars or others vehicles which have through the free area of any other carried cattle exposed to or infested State, Territory, or the District of Co- with ticks within the quarantined area lumbia, unless such material is first of any State shall be cleaned and treat- disinfected in accordance with the pro- ed in the required concentration with a visions of § 72.24. permitted dip listed in § 72.13 before being moved interstate under super- § 72.20 Exhibition of noninfected cattle vision of a State or Federal inspector in the quarantined area; restric- or an accredited veterinarian. tions under which permitted. [38 FR 21996, Aug. 15, 1973] The exhibition of noninfected cattle at fairs or exhibitions in the quar- § 72.24 Litter and manure from car- antined area and their reshipment to riers and premises of tick-infested the free area without dipping may, by animals; destruction or treating rewritten order of the Administrator, quired. APHIS be permitted: Provided, That The litter and manure removed from the cattle shall be handled under such cars, boats, or other vehicles and from conditions as may be prescribed in each pens, chutes, alleys, or other premises case to preclude any danger of the or inclosures which have contained spread of infection. interstate shipments of tick-infested [28 FR 5940, June 13, 1963, as amended at 56 animals, shall be destroyed or treated FR 51974, Oct. 17, 1991] by the transportation or yard company, or other owner thereof, under § 72.21 Animals infested with or ex- APHIS supervision, by saturating it in posed to ticks subject to same re- the required concentration with a per- strictions as cattle. mitted dip listed in § 72.13, or shall be Animals other than cattle which are otherwise disposed of under prior per- infested with ticks [Boophilus mission received from the Adminis- annulatus (Margaropus annulatus), trator, APHIS. Boophilus microplus, or Rhipicephalus evertsi evertsi] or exposed to tick in- [38 FR 21996, Aug. 15, 1973, as amended at 56 festation shall not be moved interstate FR 51974, 51975, Oct. 17, 1991] unless they are treated, handled, and moved in accordance with the require- § 72.25 Dipping methods. ments specified in §§ 72.9 through 72.15 Dipping is accomplished by thor- and § 72.18 of this part governing the oughly wetting the entire skin by ei- interstate movement of cattle. ther immersion in a chemical solution in a dip vat, or by spraying with a § 72.22 Cars, vehicles, and premises; chemical solution using a spray-dip cleaning and treatment after con- machine or a hand-held sprayer. taining infested or exposed animals. Cars and other vehicles, and yards, [50 FR 430, Jan. 4, 1985] pens, chutes, or other premises or facilities, which have contained inter- PART 73—SCABIES IN CATTLE state shipments of animals infested with or exposed to ticks, shall be Sec. cleaned and treated within 72 hours of 73.1 Interstate movement prohibited. use and prior to further use in the re- 73.1a [Reserved] quired concentration with a permitted 73.1b Quarantine policy. dip listed in § 72.13 under supervision of 73.1c Definitions.

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73.2 Interstate shipment for immediate may promulgate regulations and may slaughter from quarantined or nonquar- prohibit or restrict the movement in antined areas; conditions under which interstate commerce of any animal, ar- permitted. 73.3 Shipment for purposes other than ticle, or means of conveyance as the slaughter; conditions under which per- Secretary determines necessary to pre- mitted. vent the introduction or dissemination 73.4 Interstate shipment of exposed but not of any pest or disease of livestock. Pur- visibly diseased cattle from a quar- suant to this authority, the Depart- antined or nonquarantined area; condi- ment has quarantined various areas be- tions under which permitted. cause of cattle scabies and has issued 73.5 Interstate shipment of undiseased cattle from quarantined area; when per- the regulations in this part governing mitted. the interstate movement of cattle from 73.6 Placarding means of conveyance and such areas. It is the policy of the De- marking billing of shipments of treated partment to quarantine those portions scabby cattle or cattle exposed to sca- of any State that are clearly identifi- bies. able, and in which exist animals af- 73.7 Movement from quarantined to free fected with cattle scabies, or mites area and shipment therefrom; restrictions under which permitted. which are the contagion of said disease 73.8 Cattle infected or exposed during tran- and not to quarantine an entire State sit. for cattle scabies if the State adopts 73.9 Owners assume responsibility; must and enforces requirements for the execute agreement prior to dipping or intrastate movement of cattle that are treatment waiving all claims against at least as stringent as the require- United States. 73.10 Permitted dips; substances allowed. ments in the regulations in this part 73.11 Treatment of means of conveyance for interstate movements of cattle. and premises having contained scabby Further, it is the policy of the Depart- cattle. ment to remove the quarantine from 73.12 Ivermectin. any quarantined area when it is deter- AUTHORITY: 7 U.S.C. 8301–8317; 7 CFR 2.22, mined that scabies-affected animals 2.80, and 371.4. and the mites which are the contagion of scabies no longer exist in such areas. § 73.1 Interstate movement prohibited. [38 FR 31671, Nov. 16, 1973, as amended at 68 (a) Cattle affected with scabies. No cat- FR 6343, Feb. 7, 2003] tle affected with scabies shall be shipped, trailed, driven, or otherwise § 73.1c Definitions. moved interstate for any purpose except as provided in this part. For purposes of this part the fol- (b) Cattle affected with or exposed to lowing terms shall have the meaning scabies. No cattle which, just prior to set forth in this section. movement, were affected with or ex- Administrator. The Administrator, posed to scabies shall be shipped, Animal and Plant Health Inspection trailed, driven, or otherwise moved Service, or any person authorized to interstate for any purpose except as act for the Administrator. provided in this part. Animal and Plant Health Inspection (c) Cattle from area quarantined for Service. The Animal and Plant Health scabies. No cattle shall be shipped, Inspection Service of the United States trailed, driven, or otherwise moved Department of Agriculture (APHIS or interstate from the area quarantined Service). for the disease of scabies in cattle ex- APHIS Inspector. A veterinarian or cept as provided in this part. livestock inspector employed by the [28 FR 5945, June 13, 1963, as amended at 41 Animal and Plant Health Inspection FR 5384, Feb. 6, 1976] Service, U.S. Department of Agri- culture, in animal health activities, § 73.1a [Reserved] who is authorized to perform the function involved. § 73.1b Quarantine policy. State Inspector. A veterinarian or live- Under the Animal Health Protection stock inspector regularly employed in Act (7 U.S.C. 8301 et seq.), the Secretary animal health activities by a State or

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a political subdivision thereof, author- APHIS or State inspector within 10 ized by such State or political subdivi- days prior to the date of shipment and sion to perform the function involved when accompanied by a certificate under a cooperative agreement with from such inspector showing the cattle the U.S. Department of Agriculture. to be free from disease. [41 FR 5384, Feb. 6, 1976, as amended at 56 FR [31 FR 8907, June 28, 1966, as amended at 36 52463, Oct. 21, 1991] FR 23996, Dec. 17, 1971; 38 FR 18011, July 6, 1973; 41 FR 5384, Feb. 6, 1976; 49 FR 10530, Mar. § 73.2 Interstate shipment for imme- 20, 1984; 49 FR 33120, Aug. 21, 1984; 56 FR 52463, diate slaughter from quarantined Oct. 21, 1991; 66 FR 21062, Apr. 27, 2001] or nonquarantined areas; conditions under which permitted. § 73.3 Shipment for purposes other than slaughter; conditions under (a) Conditions under which permitted which permitted. after one dipping. Cattle which, just prior to shipment, were affected with Cattle affected with scabies may be scabies but have been dipped once in a shipped interstate for any purpose if permitted dip (other than a toxaphene dipped twice in a permitted dip, 10 to 14 dip), under the supervision of an days apart, under the supervision of an APHIS inspector or State inspector, APHIS inspector or State inspector, within 10 days prior to the date of ship- and so certified by such inspector, or ment may be shipped or transported such cattle may be so shipped if dipped interstate for immediate slaughter to a once in a permitted dip under APHIS recognized slaughtering center, upon supervision or State supervision at the point of origin, provided arrangements compliance with the following condi- have been made for the second dipping, tions: under APHIS supervision, en route or (1) They shall not be diverted en at destination within 10 to 14 days after route. the first dipping. If shipped in the lat- (2) The means of conveyance shall be ter manner the means of conveyance placarded and the billing shall be containing the cattle shall be plac- marked ‘‘Treated Scabby Cattle,’’ in arded and the billing shall be marked accordance with § 73.6. ‘‘Treated Scabby Cattle,’’ in accord- (b) After one dipping; to be slaughtered ance with § 73.6. within 14 days or redipped by owner. Cat- tle shipped interstate subject to the [28 FR 5945, June 13, 1963, as amended at 41 provisions of paragraph (a) of this sec- FR 5384, Feb. 6, 1976; 49 FR 10530, Mar. 20, tion shall be slaughtered within 14 days 1984; 49 FR 33120, Aug. 21, 1984; 56 FR 52463, from the date of the dipping or shall be Oct. 21, 1991; 66 FR 21062, Apr. 27, 2001] again dipped by the owner. § 73.4 Interstate shipment of exposed (c) When part of diseased herd not visi- but not visibly diseased cattle from bly affected. Cattle of the free area not a quarantined or nonquarantined visibly diseased with scabies, but which area; conditions under which per- may be part of a diseased herd, may be mitted. shipped or transported interstate for Cattle not visibly diseased with sca- immediate slaughter to any recognized bies, but which are known to be part of slaughtering center where separate a diseased herd or to have come in con- pens are provided for yarding exposed tact with diseased cattle or infectious cattle: Provided, That means of convey- means of conveyance or premises, may ance in which the cattle are trans- be shipped interstate for any purpose if ported shall be placarded and the bill- dipped at the point of origin, under the ing accompanying the shipment shall supervision of an APHIS inspector or be marked ‘‘Cattle Exposed to Scabies’’ State inspector, in a permitted dip, or in accordance with § 73.6. the cattle may be dipped en route by (d) Undiseased herds in quarantined special permission first had and ob- area; conditions under which permitted. tained from the Administrator; but in Cattle of herds of the quarantined area such event the means of conveyance which are not diseased with scabies shall be placarded and the billing shall may be shipped, transported, or other- be marked ‘‘Cattle Exposed to Sca- wise moved interstate for immediate bies,’’ in accordance with § 73.6, and the slaughter, upon inspection by an cattle shall not be permitted to mingle

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with other cattle until disposed of in the number of the cattle; (e) the point accordance with the regulations in this from which the cattle are to be moved part. interstate; (f) that the cattle shall not [28 FR 5945, June 13, 1963, as amended at 41 be diverted en route; and (g) the name FR 5384, Feb. 6, 1976; 56 FR 52463, Oct. 21, and address of the owner or shipper of 1991] the cattle.

§ 73.5 Interstate shipment of (Approved by the Office of Management and undiseased cattle from quarantined Budget under control number 0579–0051) area; when permitted. [31 FR 8907, June 28, 1966 as amended at 36 FR Cattle of any herd in any quar- 23996, Dec. 17, 1971; 38 FR 10252, Apr. 26, 1973; 38 FR 18011, July 6, 1973; 41 FR 5384, Feb. 6, antined area, which herd is not dis- 1976; 48 FR 57472, Dec. 30, 1983; 49 FR 10530, eased with scabies, may be shipped, Mar. 20, 1984; 49 FR 33120, Aug. 21, 1984; 56 FR transported, or otherwise moved inter- 52463, Oct. 21, 1991; 66 FR 21062, Apr. 27, 2001] state for any purpose upon inspection by an APHIS or State inspector within § 73.6 Placarding means of conveyance 10 days prior to the date of shipment and marking billing of shipments of and when accompanied by a certificate treated scabby cattle or cattle ex- from such inspector showing the cattle posed to scabies. to be free from such disease or expo- When cattle are shipped as ‘‘Treated sure thereto. When it is determined by Scabby Cattle,’’ or ‘‘Cattle Exposed to the Administrator that all cattle of all Scabies,’’ the transportation compa- herds in any quarantined area have nies shall securely affix to and main- been inspected for scabies by an APHIS tain upon both sides of each means of or State inspector, that all the infected conveyance carrying such cattle a du- or exposed herds have been identified, rable, conspicuous placard, not less and that all the infected herds have than 51⁄2 by 8 inches in size, on which been dipped twice, and all the exposed shall be printed with permanent black herds have been dipped in a permitted ink in boldfaced letters, not less than dip as prescribed in § 73.10, under super- 11⁄2 inches in height, the words, vision of an APHIS or APHIS-approved ‘‘Treated Scabby Cattle,’’ or ‘‘Cattle inspector, cattle of herds in such area Exposed to Scabies,’’ as the case may which are not diseased with or exposed be. These placards shall also show the to scabies may be moved interstate in name of the place from which the ship- accordance with this section, without ment was made, the date of the ship- further APHIS inspection or certifi- ment (which must correspond to the cation, directly to a slaughtering plant date of the waybills and other papers), where Federal Meat Inspection is the name of the transportation com- maintained: Provided further, that pany, and the name of the place of des- treatment with ivermectin may be tination. The carrier issuing the way- used in lieu of dipping for a herd of cat- bills, conductors’ manifests, memo- tle treated together if the herd is phys- randa, and bills of lading pertaining to ically separated for 14 days following such shipments shall plainly write or treatment from all cattle not a part of stamp upon the face of each such paper the herd treated together with the words, ‘‘Treated Scabby Cattle,’’ or ivermectin. Information may be ob- ‘‘Cattle Exposed to Scabies,’’ as the tained from an APHIS inspector wheth- case may be. If for any reason the plac- er a determination as required by this ards required by this part have not section is currently applicable to au- been affixed to the means of convey- thorize such movement. Cattle moved ance as aforesaid, or the placards have interstate under this section shall not been removed, destroyed, or rendered be diverted en route and must be ac- illegible, or the cattle are rebilled or companied by a waybill or similar doc- are transferred to other means of con- ument, or a statement signed by the veyance, the placards shall be imme- owner or shipper of the cattle, stating: diately affixed or replaced by the car- (a) That the cattle are not known to be rier, and the new waybills shall be infected with scabies or exposed there- marked as aforesaid by the carrier to; (b) [Reserved]; (c) the purpose for issuing them, the intention being that which the cattle are to be moved; (d) the billing accompanying the shipment

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shall be marked and the means of con- § 73.8 Cattle infected or exposed dur- veyance containing the cattle shall be ing transit. placarded ‘‘Treated Scabby Cattle,’’ or (a) Healthy cattle from unquarantined ‘‘Cattle Exposed to Scabies,’’ as the State exposed en route. Should healthy case may be, from the time of shipment cattle in transit from a State not quar- until the cattle arrive at destination or antined by the Secretary of Agri- point of dipping and the disposition of culture for scabies in cattle be un- the means of conveyance is indicated loaded en route and placed in infec- by an APHIS inspector or State inspec- tious premises, they shall be treated as tor. exposed cattle, and their further move- [28 FR 5945, June 13, 1963, as amended at 41 ment shall be subject to the provisions FR 5384, Feb. 6, 1976; 49 FR 10530, Mar. 20, of this part with respect to the move- 1984; 49 FR 33120, Aug. 21, 1984; 56 FR 52463, ment of exposed cattle. Oct. 21, 1991; 66 FR 21062, Apr. 27, 2001] (b) Interstate shipments of cattle under APHIS or State certificate found affected § 73.7 Movement from quarantined to or exposed en route. Cattle shipped free area and shipment therefrom; restrictions under which permitted. interstate under a certificate from an APHIS inspector or State inspector or No person, firm, or corporation shall other cattle which are found en route deliver for transportation, transport, to be affected with scabies or to have drive on foot, or otherwise move inter- been exposed thereto, shall thereafter state from the free area of any State, be handled in the same manner as dis- Territory, or the District of Columbia eased or exposed cattle are required by any cattle which have been moved from this part to be handled, and the means the quarantined area of the same of conveyance and the chutes, alleys, State, Territory, or the District of Co- and pens which have been occupied by lumbia into such free area: Provided, diseased animals shall be cleaned and however, That such cattle may be deliv- disinfected as provided in §§ 71.4 ered for transportation, transported, through 71.11 of this subchapter. driven on foot, or otherwise moved interstate for the purposes for which [28 FR 5945, June 13, 1963, as amended at 41 the shipment, transportation, or other FR 5384, Feb. 6, 1976; 56 FR 52463, Oct. 21, movement interstate of cattle of the 1991] quarantined area is permitted by this § 73.9 Owners assume responsibility; part, Provided, That in such shipment must execute agreement prior to and transportation or other movement dipping or treatment waiving all the requirements of this part governing claims against United States. the shipment and transportation or When the cattle are to be dipped other movement of cattle of the quar- under APHIS supervision or control, antined area are strictly complied the owner of the cattle offered for ship- with: And provided further, That this ment, or his agent duly authorized section shall not apply to cattle of the thereto, shall first execute and deliver quarantined area which, before being to an APHIS inspector an application moved into the free area, are certified for inspection and supervised dipping by an APHIS inspector or State inspec- wherein he shall agree to waive all tor as free from disease and are accom- claims against the United States for panied by such certificate in their ship- any loss or damage to said cattle occa- ment by transportation or other move- sioned by or resulting from dipping or ment interstate. other treatment under this part, or re- (Approved by the Office of Management and sulting from any subsequent treatment Budget under control number 0579–0051) prior to their interstate shipment, or (44 U.S.C. 3506) resulting from the fact that they are later found to be still scabies infested, [28 FR 5945, June 13, 1963, as amended at 41 and also for all subsequent loss or dam- FR 5384, Feb. 6, 1976; 48 FR 57472, Dec. 30, age to any other cattle in the posses- 1983; 56 FR 52463, Oct. 21, 1991] sion or control of such owner which

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may come into contact with the cattle dipping bath for toxaphene emulsions so dipped or treated. must be kept within a temperature ° [41 FR 4012, Jan. 28, 1976, as amended at 56 range of 40–80 F., and at a concentra- FR 52463, Oct. 21, 1991] tion between 0.50 and 0.60 percent throughout the dipping operations. 2 § 73.10 Permitted dips; substances al- (c) Proprietary brands of lime-sul- lowed. phur or toxaphene dips may be used in (a) The dips at present permitted by official dipping only after specific per- the Department for the treatment, as mission therefor has been granted by required in this part, of cattle affected the Administrator. Before a dip will be with or exposed to scabies, are as fol- specifically approved as a permitted lows: dip for the eradication of scabies in (1) Lime-sulphur dip, other than pro- cattle, the APHIS 3 will require that prietary brands thereof, made in the the product be registered under the proportion of 12 pounds of unslaked provisions of the Federal Insecticide, lime (or 16 pounds of commercial hy- Fungicide and Rodenticide Act, as drated lime, not airslaked lime) and 24 amended (7 U.S.C. 135 et seq.); that is ef- pounds of flowers of sulphur or sulphur ficacy and stability have been dem- flour to 100 gallons of water; or a spe- onstrated; that trials have been con- cifically permitted proprietary brand ducted to determine that its concentra- of lime-sulphur dip. (2) Dips made from specifically per- tion can be maintained and that under mitted proprietary brand emulsions of actual filed conditions the dipping of toxaphene and maintained throughout cattle in a bath of definite strength the dipping operation at a concentra- will effectually eradicate scabies infection between 0.50 and 0.60 percent tion without injury to the animals toxaphene. Animals treated by such dipped. dips should not be slaughtered for food [34 FR 7443, May 8, 1969, as amended at 39 FR purposes until the expiration of such 39715, Nov. 11, 1974; 40 FR 12768, Mar. 21, 1975; period as may be required under the 40 FR 42179, Sept. 11, 1975; 41 FR 5384, Feb. 6, Federal Meat Inspection Act (21 U.S.C., 1976; 41 FR 37307, Sept. 3, 1976; 50 FR 431, Jan. Supp. III, 601 et seq.). The length of this 4, 1985; 56 FR 52463, Oct. 21, 1991] required period shall be specified on each certificate issued by the APHIS § 73.11 Treatment of means of convey- inspector or State inspector who super- ance and premises having con- vises the dipping with such dips. tained scabby cattle. (3) Approved proprietary brands of Means of conveyance, yards, pens, ® coumaphos (Co-Ral ), 25 percent wet- sheds, chutes, or other premises or fa- table powder or flowable form used at a cilities which have contained cattle of concentration of 0.30 percent. a consignment in which scabies is (4) Approved proprietary brands of found shall be treated within 72 hours organophosphorous insecticides of use and prior to further use in the (Prolate ®) used at a concentration of required concentration with a per- 0.15 percent to 0.25 percent. mitted dip listed in § 73.10 under super- (b) The dipping bath for lime-sulphur dip must be used at a temperature of 95 vision of a State or Federal inspector ° to 105 °F., and must be maintained or an accredited veterinarian. through the dipping operation at a con- [38 FR 21996, Aug. 15, 1973, as amended at 41 centration of not less than 2 percent of FR 5384, Feb. 6, 1976] ‘‘sulphide sulphur’’, as indicated by the field test for lime-sulphur dipping 2 Care must be exercised in dipping animals baths approved by the APHIS. 1 The and in maintaining the bath at the standard concentration. Detailed instructions will be 1 The field test for lime-sulphur dipping issued for the guidance of employees who baths is described in U.S. Department of Ag- may be called upon to use them in the sca- riculture Bulletin 163, for sale by the Super- bies eradication program. intendent of Documents, Government Print- 3 Information as to the names of such dips ing Office, Washington, D.C. 20402, at 5 cents may be obtained from the APHIS or a APHIS a copy. inspector.

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§ 73.12 Ivermectin. 1 interstate without restrictions under this part. Accordingly, cattle from nonquar- (a) Cattle affected with scabies or antined areas which had been treated with which just prior to movement were af- ivermectin more than 14 days before move- fected with or exposed to scabies may ment interstate may be moved interstate be moved interstate from a nonquar- without restriction under this part unless antined area after being treated with following treatment they become affected ivermectin under the supervision of an with scabies or just prior to movement be- APHIS inspector or State inspector in come affected with or exposed to scabies. accordance with the directions on the (b) Cattle may be moved interstate label of the drug if the following condi- from a quarantined area after being tions are met: treated with ivermectin under the su- (1) Such cattle are kept physically pervision of an APHIS inspector or separated for 14 days following treat- State inspector in accordance with the ment from all cattle not part of the group treated together with ivermectin directions on the label of the drug if (regardless of whether the cattle are the following conditions are met: moved interstate before the end of the (1) Such cattle are moved interstate 14-day period); and within 21 days following treatment (2) If such cattle are moved inter- with ivermectin; and state before the end of the 14th day fol- (2) Such cattle are kept physically lowing treatment, at the time of inter- separated for 14 days following treat- state movement they are accompanied ment from all cattle not part of the by a certificate issued and signed by an group treated together with ivermectin APHIS inspector or State inspector (regardless of whether the cattle are identifying the group of cattle treated moved interstate before the end of the with ivermectin and stating the date 14 day period); and, if such cattle are on which the cattle were treated with moved within the 15- to 21-day period ivermectin; and following treatment, they remain kept (3) If such cattle are moved inter- physically separated from all cattle state before the end of the 14th day fol- not a part of the group treated to- lowing treatment, at the time of inter- gether with ivermectin until after they state movement the means of convey- are moved interstate; and ance carrying them is placarded and (3) Such cattle are accompanied at the billing marked in accordance with the time of interstate movement by a § 73.6. certificate issued and signed by an NOTE: Cattle from nonquarantined areas APHIS inspector or State inspector which are not affected with scabies or which identifying the group of cattle treated just prior to movement were not affected with ivermectin and stating the date with or exposed to scabies may be moved on which the cattle were treated with ivermectin; and 1 Tissue residues remain following treat- (4) If such cattle are moved inter- ment with ivermectin. Cattle treated with ivermectin are not allowed to be slaughtered state before the end of the 14 day pe- for food purposes until the expiration of such riod following treatment, at the time period as may be required under the Federal of interstate movement the means of Meat Inspection Act (21 U.S.C. 601 et seq.). conveyance carrying them is placarded Further, the animal drug regulations in 21 and the billing marked in accordance CFR parts 522 and 556 promulgated under the with § 73.6. Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) contain limitations on the [49 FR 10530, Mar. 20, 1984 and 49 FR 33120, use of ivermectin and contain tolerances for Aug. 21, 1984; 56 FR 52463, Oct. 21, 1991; 66 FR ivermectin in edible cattle tissue. With re- 21062, Apr. 27, 2001] spect to the limitations 21 CFR part 522 provides the following: ‘‘For subcutaneous use only. Not for intramuscular use. Do not treat PART 74—PROHIBITION OF INTER- cattle within 35 days of slaughter. Because a STATE MOVEMENT OF LAND TOR- withdrawal time in milk has not been estab- TOISES lished, do not use in female dairy cattle of breeding age. Federal law restricts this drug to use by or on the order of a licensed veteri- AUTHORITY: 7 U.S.C. 8301–8317; 7 CFR 2.22, narian.’’ 2.80, and 371.4.

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§ 74.1 General prohibition. D of this chapter, and to perform func- The interstate movement of leopard tions required by cooperative State- tortoise (Geochelone pardalis), African Federal disease control and eradication spurred tortoise (Geochelone sulcata), programs. and Bell’s hingeback tortoise (Kinixys Administrator. The Administrator, belliana) is prohibited except when tor- Animal and Plant Health Inspection toises are accompanied by either a Service, or any person authorized to health certificate or a certificate of act for the Administrator. veterinary inspection. The health cer- Animal and Plant Health Inspection tificate or certificate of veterinary in- Service. The Animal and Plant Health spection must be signed by an accred- Inspection Service of the United States ited veterinarian within 30 days prior Department of Agriculture (APHIS or to the interstate movement and must Service). state that the tortoises have been ex- Animals. Cattle, sheep, goats, other amined by that veterinarian and found ruminants, swine, horses, asses, mules, free of ticks. zebras, dogs, and poultry. APHIS representative. An individual [66 FR 37128, July 17, 2001] employed by APHIS who is authorized to perform the functions involved. PART 75—COMMUNICABLE DIS- Approved stockyard. A stockyard, live- EASES IN HORSES, ASSES, stock market, or other premises, under PONIES, MULES, AND ZEBRAS state or federal veterinary supervision where horses or other equines are as- DOURINE IN HORSES AND ASSES sembled for sale purposes, and which Sec. has been approved by the Adminis- 75.1–75.3 [Reserved] trator under § 71.20 of this chapter. Certificate. An official document EQUINE INFECTIOUS ANEMIA (SWAMP FEVER) issued by a State representative, 75.4 Interstate movement of equine infec- APHIS representative, or an accredited tious anemia reactors and approval of veterinarian at the point of origin of laboratories, diagnostic facilities, and re- the interstate movement on which are search facilities. listed: (1) The description, including CONTAGIOUS EQUINE METRITIS (CEM) age, breed, color, sex, and distinctive markings when present (such as 75.5–75.10 [Reserved] brands, tattoos, scars or blemishes), of AUTHORITY: 7 U.S.C. 8301–8317; 7 CFR 2.22, each reactor to be moved; (2) the num- 2.80, and 371.4. ber of reactors covered by the docu- SOURCE: 28 FR 5950, June 13, 1963, unless ment; (3) the purpose for which the re- otherwise noted. actors are to be moved; (4) the points of origin and destination; (5) consignor; DOURINE IN HORSES AND ASSES and (6) the consignee; and which states that each reactor identified on the cer- §§ 75.1–75.3 [Reserved] tificate meets the requirements of EQUINE INFECTIOUS ANEMIA (SWAMP § 75.4(b). FEVER) Interstate. From any State into or through any other State. § 75.4 Interstate movement of equine Official seal. A serially numbered infectious anemia reactors and ap- metal or plastic strip, or a serially proval of laboratories, diagnostic numbered button, consisting of a self- facilities, and research facilities. locking device on one end and a slot on (a) Definitions. For the purpose of this the other end, which forms a loop when section, the following terms have the the ends are engaged and which cannot meanings set forth in this paragraph. be reused if opened. It is applied by an Accredited veterinarian. A veteri- APHIS representative or State rep- narian approved by the Administrator resentative. in accordance with the provisions of Official test. Any test for the labora- part 161 of this title to perform func- tory diagnosis of equine infectious ane- tions specified in parts 1, 2, 3, and 11 of mia that utilizes a diagnostic product subchapter A, and subchapters B, C and that is: (1) Produced under license from

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the Secretary of Agriculture, and found State. Any State, the District of Co- to be efficacious for that diagnosis, lumbia, Puerto Rico, the Virgin Islands under the Virus-Serum-Toxin Act of of the United States, Guam, the North- March 4, 1913, and subsequent amend- ern Mariana Islands, or any other terri- ments (21 U.S.C. 151 et seq.); and (2) con- tory or possession of the United States. ducted in a laboratory approved by the State animal health official. The Administrator. individial employed by a State who is Officially identified. The permanent responsible for livestock and poultry identification of a reactor using the disease control and eradication pro- National Uniform Tag code number as- grams. signed by the United States Depart- State representative. An individual em- ment of Agriculture to the State in ployed in animal health activities of a which the reactor was tested, followed State or a State’s political subdivision, by the letter ‘‘A’’, 1 which markings who is authorized by that State to per- shall be permanently applied to the reform the function involved under a co- actor by an APHIS representative, operative agreement with the United State representative or accredited vet- States Department of Agriculture. erinarian who shall use for the purpose Veterinarian in Charge. The veteri- a hot iron or chemical brand, nary official of APHIS who is assigned freezemarking or a lip tattoo. If hot by the Administrator to supervise and iron or chemical branding or perform the animal health activities of freezemarking is used, the markings APHIS in the State concerned. shall be not less than two inches high (b) Interstate movement. No reactor and shall be applied to the left shoulder may be moved interstate unless the re- or left side of the neck of the reactor. actor is officially identified, is accom- If a lip tattoo is used, each character of panied by a certificate, and meets the the tattoo shall be not less than one conditions of either paragraph (b)(1), inch high and three-fourths of an inch (b)(2), (b)(3), or (b)(4) of this section: wide and shall be applied to the inside Provided, That official identification is surface of the upper lip of the reactor. not necessary if the reactor is moved Operator. The individual responsible directly to slaughter under a permit for the day-to-day operations of the and in a conveyance sealed with an of- specifically approved stockyard. ficial seal: Permit. An official document (VS (1) The reactor is moved interstate Form 1–27 or a State form which con- for immediate slaughter, either to a tains the same information, but not a Federally inspected slaughtering estab- ‘‘permit for entry’’) issued by an lishment operating under the provi- APHIS representative, State represent- sions of the Federal Meat Inspection ative, or accredited veterinarian which Act (21 U.S.C. 601 et seq.) or to a State- lists the owner’s name and address, inspected slaughtering establishment points of origin and destination, num- that has inspection by a State rep- ber of animals covered, purpose of the resentative at time of slaughter; or movement, and one of the following: (2) The reactor is moved interstate to The individual animal registered breed a diagnostic or research facility after association registration tattoo, indi- the individual issuing the certificate vidual animal registered breed associa- has consulted with the State animal tion registration number, or similar in- health official in the State of destina- dividual identification, including name, age, sex, breed, color, and mark- tion and has determined that the reac- ings. tor to be moved interstate will be Reactor. Any horse, ass, mule, pony maintained in isolation sufficient to or zebra which is subjected to an offi- prevent the transmission of equine in- cial test and found positive. fectious anemia to other horses, asses, ponies, mules, or zebras, and will remain quarantined under State author- 1 Information as to the National Uniform ity at the diagnostic or research facil- Tag code number system can be obtained from the Animal and Plant Health Inspec- ity until natural death, slaughter, or tion Service, Veterinary Services, National until disposed of by euthanasia; or Animal Health Programs, 4700 River Road (3) The reactor is moved interstate to Unit 43, Riverdale, Maryland 20737–1231. its home farm after the individual

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issuing the certificate has consulted (2) The Administrator will approve with the State animal health official in diagnostic or research facilities to the State of destination and has deter- which reactors may be moved inter- mined that the reactor to be moved state under paragraph (b)(2) of this sec- interstate will be maintained in isolation, after a determination by the Ad- tion sufficient to prevent the trans- ministrator that the facility has facili- mission of equine infectious anemia to ties and employs procedures which are other horses, asses, ponies, mules, or adequate to prevent the transmission zebras, and will remain quarantined of equine infectious anemia from reac- under State authority on the reactor’s tors to other equine animals. 3 home farm until natural death, slaugh- (d) Denial and withdrawal of approval ter, or until disposed of by euthanasia; of laboratories and diagnostic or research and facilities. The Administrator may deny (4) The reactor is moved interstate or withdraw approval of any laboratory through no more than one approved to conduct the official test, or of any stockyard for sale for immediate diagnostic or research facility to re- slaughter, and is moved within five ceive reactors moved interstate, upon a days of its arrival at the approved determination that the laboratory or stockyard directly to: diagnostic or research facility does not (i) Slaughter at a federally inspected meet the criteria for approval under slaughtering establishment operating paragraph (c) of this section. under the provisions of the Federal (1) In the case of a denial, the oper- Meat Inspection Act (21 U.S.C. 601 et ator of the laboratory or facility will seq.), or, be informed of the reasons for denial (ii) Slaughter at a state-inspected and may appeal the decision in writing slaughtering establishment that has to the Administrator within 10 days inspection by a state representative at after receiving notification of the de- the time of slaughter, or, nial. The appeal must include all of the (iii) The home farm of the reactor in facts and reasons upon which the per- accordance with paragraph (b)(3) of son relies to show that the laboratory this section. or facility was wrongfully denied ap- (c) Approval of Laboratories, and Diag- proval to conduct the official test or nostic or Research Facilities. (1) The Ad- receive reactors moved interstate. The ministrator will approve laboratories Administrator will grant or deny the to conduct the official test only after appeal in writing as promptly as cir- consulting with the State animal cumstances permit, stating the reason health official in the State in which for his or her decision. If there is a con- the laboratory is located and after de- flict as to any material fact, a hearing termining that the laboratory: will be held to resolve the conflict. (i) Has technical personnel assigned Rules of practice concerning the hear- to conduct the official test who have ing will be adopted by the Adminis- received training prescribed by the Na- trator. tional Veterinary Services Labora- (2) In the case of withdrawal, before tories; such action is taken, the operator of (ii) Uses United States Department of the laboratory or facility will be in- Agriculture licensed antigen; formed of the reasons for the proposed (iii) Follows standard test protocol prescribed by the National Veterinary addresses of approved laboratories can be ob- Services Laboratories; tained from the Animal and Plant Health In- (iv) Meets check test proficiency re- spection Service, Veterinary Services, Na- quirements prescribed by the National tional Animal Health Programs, 4700 River Veterinary Services Laboratories; and Road Unit 43, Riverdale, Maryland 20737–1231. (v) Reports all official test results to 3 Facilities and procedures which are ade- the State animal health official and quate to prevent the transmission of equine infectious anemia, and the names and ad- 2 the Veterinarian in Charge. dresses of approved diagnostic or research facilities, can be obtained from the Animal 2 Training requirements, standard test pro- and Plant Health Inspection Service, Veteri- tocols, and check test proficiency require- nary Services, National Animal Health Pro- ments prescribed by the National Veterinary grams, 4700 River Road Unit 43, Riverdale, Services Laboratories, and the names and Maryland 20737–1231.

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withdrawal. The operator of the labora- or research facility no longer receives tory or facility may appeal the pro- reactors moved interstate. posed withdrawal in writing to the Ad- (Approved by the Office of Management and ministrator within 10 days after being Budget under control number 0579–0051) informed of the reasons for the pro- [51 FR 12597, Apr. 14, 1986, as amended at 51 posed withdrawal. The appeal must in- FR 30327, Aug. 26, 1986; 55 FR 13506, 13507, clude all of the facts and reasons upon Apr. 11, 1990; 57 FR 2440, Jan. 22, 1992; 57 FR which the person relies to show that 57337, Dec. 4, 1992; 59 FR 67133, Dec. 29, 1994; the reasons for the proposed with- 59 FR 67613, Dec. 30, 1994; 60 FR 14619, Mar. 20, drawal are incorrect or do not support 1995; 62 FR 27936, May 22, 1997; 66 FR 21062, the withdrawal of the approval of the Apr. 27, 2001] laboratory or facility to conduct the CONTAGIOUS EQUINE METRITIS (CEM) official test or receive reactors moved interstate. The Administrator will §§ 75.5–75.10 [Reserved] grant or deny the appeal in writing as promptly as circumstances permit, PART 76 [RESERVED] stating the reason for his or her decision. If there is a conflict as to any ma- PART 77—TUBERCULOSIS terial fact, a hearing will be held to resolve the conflict. Rules of practice Subpart A—General Provisions concerning the hearing will be adopted by the Administrator. However, the Sec. withdrawal shall become effective 77.1 Material incorporated by reference. 77.2 Definitions. pending final determination in the pro- 77.3 Tuberculosis classifications of States ceeding when the Administrator deter- and zones. mines that such action is necessary to 77.4 Application for and retention of zones. protect the public health, interest, or safety. Such withdrawal shall be effec- Subpart B—Cattle and Bison tive upon oral or written notification, 77.5 Definitions. whichever is earlier, to the operator of 77.6 Applicability of this subpart. the laboratory or facility. In the event 77.7 Accredited-free States or zones. of oral notification, written confirma- 77.8 Interstate movement from accredited- tion shall be given as promptly as cir- free States and zones. cumstances allow. The withdrawal 77.9 Modified accredited advanced States or zones. shall continue in effect pending the 77.10 Interstate movement from modified completion of the proceeding, and any accredited advanced States and zones. judicial review thereof, unless other- 77.11 Modified accredited States or zones. wise ordered by the Administrator. 77.12 Interstate movement from modified (3) Approval for a laboratory to con- accredited States and zones. duct the official test will be automati- 77.13 Accreditation preparatory States or zones. cally withdrawn by the Administrator 77.14 Interstate movement from accredita- when the operator of the approved lab- tion preparatory States and zones. oratory notifies the National Veteri- 77.15 Nonaccredited States or zones. nary Services Laboratories in Ames, 77.16 Interstate movement from nonaccred- Iowa, in writing, that the laboratory ited States and zones. no longer conducts the official test. 77.17 Interstate movement of cattle and bison that are exposed, reactors, or sus- (4) Approval for a diagnostic or re- pects, or from herds containing suspects. search facility to receive reactors 77.18 Other movements. moved interstate will be automatically 77.19 Cleaning and disinfection of premises, withdrawn by the Administrator when conveyances, and materials. the operator of the approved diagnostic Subpart C—Captive Cervids or research facility notifies the Admin- istrator, in writing, that the diagnostic 77.20 Definitions. 77.21 Applicability of this subpart. 77.22 Accredited-free States or zones. 77.23 Interstate movement from accredited- free States and zones.

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77.24 Modified accredited advanced States the availability of this material at or zones. NARA, call 202–741–6030, or go to: http:// 77.25 Interstate movement from modified www.archives.gov/federallregister/ accredited advanced States and zones. code of federal regulations/ 77.26 Modified accredited States or zones. l l l 77.27 Interstate movement from modified ibrllocations.html; accredited States and zones. (2) Are available for inspection at the 77.28 Accreditation preparatory States or APHIS reading room, room 1141, USDA zones. South Building, 14th Street and Inde- 77.29 Interstate movement from accredita- pendence Avenue, SW., Washington, tion preparatory States and zones. DC; or 77.30 Nonaccredited States or zones. 77.31 Interstate movement from nonaccred- (3) May be obtained from the Na- ited States and zones. tional Animal Health Programs, Vet- 77.32 General restrictions. erinary Services, APHIS, 4700 River 77.33 Testing procedures for tuberculosis in Road Unit 43, Riverdale, MD 20737–1231. captive cervids. 77.34 Official tuberculosis tests. [65 FR 63517, Oct. 23, 2000, as amended at 69 77.35 Interstate movement from accredited FR 18803, Apr. 9, 2004] herds. 77.36 Interstate movement from qualified § 77.2 Definitions. herds. As used in this part, the following 77.37 Interstate movement from monitored terms shall have the meanings set herds. 77.38 Interstate movement from herds that forth in this section except as other- are not accredited, qualified, or mon- wise specified. itored. Accredited veterinarian. A veteri- 77.39 Other interstate movements. narian approved by the Administrator 77.40 Procedures for and interstate move- in accordance with the provisions of ment to necropsy and slaughter. part 161 of subchapter J to perform 77.41 Cleaning and disinfection of premises, functions specified in subchapters B, C, conveyances, and materials. and D of this chapter. AUTHORITY: 7 U.S.C. 8301–8317; 7 CFR 2.22, Administrator. The Administrator, 2.80, and 371.4. Animal and Plant Health Inspection SOURCE: 65 FR 63517, Oct. 23, 2000, unless Service, or any person authorized to otherwise noted. act for the Administrator. Affected herd. A herd of livestock in Subpart A—General Provisions which there is strong and substantial evidence that Mycobacterium bovis ex- § 77.1 Material incorporated by ref- ists. This evidence should include, but erence. is not limited to, any of the following: Uniform Methods and Rules—Bovine Histopathology, polymerase chain re- Tuberculosis Eradication. The Uniform action (PCR) assay, bacterial isolation Methods and Rules—Bovine Tuber- or detection, testing data, or epidemio- culosis Eradication (January 22, 1999, logic evidence such as contact with edition) has been approved for incorpo- known sources of infection. ration by reference into the Code of Animal. All species of animals except Federal Regulations by the Director of man, birds, or reptiles. the Federal Register in accordance Animal and Plant Health Inspection with 5 U.S.C. 552(a) and 1 CFR part 51. Service (APHIS). The Animal and Plant (a) The procedures specified in the Health Inspection Service of the United Uniform Methods and Rules—Bovine States Department of Agriculture. Tuberculosis Eradication (January 22, Animal identification number (AIN). A 1999, edition) must be followed for the numbering system for the official iden- interstate movement of certain ani- tification of individual animals in the mals regulated under this part. United States providing a nationally (b) Availability. Copies of the Uniform unique identification number for each Methods and Rules—Bovine Tuber- animal. The AIN contains 15 digits, culosis Eradication: with the first 3 being the country code (1) Are available for inspection at the (840 for the United States), the alpha National Archives and Records Admin- characters USA, or the numeric code istration (NARA). For information on assigned to the manufacturer of the

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identification device by the Inter- in conjunction with APHIS representa- national Committee on Animal Record- tives, in which an official test for tu- ing. The AIN beginning with the 840 berculosis is conducted on all livestock prefix may be used only on animals in any tuberculosis-affected herd in a born in the United States. State or zone, all livestock in any herd APHIS representative. An individual into which livestock from the affected employed by APHIS who is authorized herd have been moved, all potential tu- to perform the function involved. berculosis source herds, and all live- Area veterinarian in charge. The vet- stock herds and animals that are likely erinary official of APHIS who is as- to have been exposed to the affected signed by the Administrator to super- herd. vise and perform the official animal Herd. Except for livestock assembled health work of APHIS in the State con- at feedlots, any group of livestock cerned. maintained for at least 4 months on Certificate. An official document common ground for any purpose, or issued by an APHIS representative, a State representative, or an accredited two or more groups of livestock under veterinarian at the point of origin of a common ownership or supervision, geo- shipment of livestock to be moved graphically separated but that have an under this part, which shows the iden- interchange or movement of livestock tification tag, tattoo, or registration without regard to health status, as de- number or similar identification of termined by the Administrator. each animal to be moved; the number, Interstate. From one State into or breed, sex, and approximate age of the through any other State. animals covered by the document; the Livestock. Cattle, bison, cervids, purpose for which the animals are to be swine, dairy goats, and other hoofed moved; the date and place of issuance; animals (such as llamas, alpacas, and the points of origin and destination; antelope) raised or maintained in cap- the consignor and the consignee; and tivity for the production of meat and which states that the animal or ani- other products, for sport, or for exhi- mals identified on the certificate meet bition, as well as previously free-rang- the requirements of this part. ing cervids that are captured, identi- Cooperating State and Federal animal fied, and moved interstate. health officials. The State and Federal Moved. Shipped, transported, or oth- animal health officials responsible for erwise moved, or delivered or received overseeing and implementing the Na- for movement. tional Cooperative State/Federal Bo- Moved directly. Moved without stop- vine Tuberculosis Eradication Pro- ping or unloading at livestock assem- gram. bly points of any type. Livestock being Depopulate. To destroy all livestock moved directly may be unloaded from in a herd by slaughter or by death otherwise. the means of conveyance while en Designated tuberculosis epidemiologist route only with permission of the State (DTE). A State or Federal epidemiolo- animal health official and only if the gist designated by the Administrator animals are isolated so that they can- to make decisions concerning the use not mingle with any livestock other and interpretation of diagnostic tests than those with which they are being for tuberculosis and the management shipped. of tuberculosis affected herds. A DTE Official eartag. An identification tag has the responsibility to determine the providing unique identification for in- scope of epidemiologic investigations, dividual animals. An official eartag determine the status of animals and which contains or displays an AIN with herds, assist in the development of in- an 840 prefix must bear the U.S. shield. dividual herd plans, and coordinate dis- The design, size, shape, color, and ease surveillance and eradication pro- other characteristics of the official grams within the geographic area of eartag will depend on the needs of the the DTE’s responsibility. users, subject to the approval of the Epidemiologic investigation. An inves- Administrator. The official eartag tigation that is conducted by a State must be tamper-resistant and have a

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high retention rate in the animal. Offi- (1) The State’s two-letter postal ab- cial eartags must adhere to one of the breviation followed by the premises’ following numbering systems: assigned number; or (1) National Uniform Eartagging Sys- (2) A seven-character alphanumeric tem. code, with the right-most character (2) Animal identification number being a check digit. The check digit (AIN). number is based upon the ISO 7064 Mod (3) Premises-based number system. 36/37 check digit algorithm. The premises-based number system Premises of origin identification. (1) An combines an official premises identi- APHIS-approved eartag or tattoo bear- fication number (PIN), as defined in ing a premises identification number this section, with a producer’s live- (PIN), as defined in this section; stock production numbering system to (2) A name assigned by a State or provide a unique identification num- Federal animal health authority to the ber. The PIN and the production num- premises on which the animals origi- ber must both appear on the official nated that, in the judgment of that tag. State or Federal animal health authority, is a geographically distinct loca- (4) Any other numbering system ap- tion from other livestock production proved by the Administrator for the units; or identification of animals in commerce. (3) A brand registered with an official Official seal. A seal issued by a State brand registry. or APHIS representative, consisting of State. Any State, the District of Co- a serially numbered, metal or plastic lumbia, Puerto Rico, or any territory strip, with a self-locking device on one of the United States. end and a slot on the other end, which State animal health official. The State forms a loop when the ends are engaged official responsible for livestock and and that cannot be reused if opened, or poultry disease control and eradication a serially numbered, self-locking but- programs. ton that can be used for this purpose. State representative. A veterinarian or Officially identified. Identified by other person employed in livestock means of an official eartag or by means sanitary work of a State or a political of an individual tattoo or hot brand subdivision of a State and who is au- that provides unique identification for thorized by such State or political sub- each animal. division of a State to perform the func- Person. Any individual, corporation, tion involved under a memorandum of company, association, firm, partner- understanding with APHIS. ship, society, joint stock company, or Transportation document. Any docu- other legal entity. ment accompanying the interstate Premises identification number (PIN). A movement of livestock, such as an nationally unique number assigned by owner’s statement, manifest, switch a State, Tribal, and/or Federal animal order, or vehicle record, on which is health authority to a premises that is, stated the point from which the ani- in the judgment of the State, Tribal, mals are moved interstate, the destina- and/or Federal animal health author- tion of the animals, the number of ani- ity, a geographically distinct location mals covered by the document, and the from other premises. The premises name and address of the owner or ship- identification number is associated per. with an address, geospatial coordi- Tuberculosis. The contagious, infec- nates, and/or other location descriptors tious, and communicable disease which provide a verifiably unique loca- caused by Mycobacterium bovis. (Also re- tion. The premises identification num- ferred to as bovine tuberculosis.) ber may be used in conjunction with a United States. All of the States. producer’s own livestock production Zone. A defined geographic land area numbering system to provide a unique identifiable by geological, political, identification number for an animal. manmade, or surveyed boundaries, The premises identification number with mechanisms of disease spread, ep- may consist of: idemiological characteristics, and the

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ability to control the movement of ani- cies at risk of tuberculosis at a rate mals across the boundaries of the zone that allows detection of tuberculosis in taken into account. the overall population of livestock at a [65 FR 63517, Oct. 23, 2000, as amended at 66 2 percent prevalence rate with 95 per- FR 7592, Feb. 20, 2002; 69 FR 64649, Nov. 8, cent confidence. The designated tuber- 2004; 70 FR 61026, Oct. 20, 2005; 72 FR 39305, culosis epidemiologist must review re- July 18, 2007; 73 FR 54062, Sept. 18, 2008] ports of all testing for each zone within the State within 30 days of the testing; § 77.3 Tuberculosis classifications of and States and zones. (3) The State must enter into a The Administrator shall classify each memorandum of understanding with State for tuberculosis in accordance APHIS in which the State agrees to ad- with this part. A zone comprising less here to any conditions for zone rec- than an entire State will be given a ognition particular to that request. particular classification upon request (b) Retention of APHIS recognition of the State only if the Administrator of a zone is subject to annual review by determines that: the Administrator. To retain recogni- (a) The State meets the requirements tion of a zone, a State must continue of this part for establishment of zones; to comply with the requirements of (b) The State has adopted and is en- paragraphs (a)(1), (a)(2), and (a)(3) of forcing regulations that impose restric- this section, as well as the require- tions on the intrastate movement of ments for maintaining or improving cattle, bison, and captive cervids that the tuberculosis risk classification of are substantially the same as those in each zone in the State, and must retain place under this part for the interstate for at least 2 years all certificates re- movement of cattle, bison, and captive quired under this part for the move- cervids; and ment of cattle, bison, and captive (c) The designation of part of a State cervids. as a zone will otherwise be adequate to prevent the interstate spread of tuber- (Approved by the Office of Management and culosis. Budget under control number 0579–0146)

§ 77.4 Application for and retention of zones. Subpart B—Cattle and Bison (a) A State animal health official § 77.5 Definitions. may request at any time that the Ad- ministrator designate part of a State As used in subpart B, the following as having a different tuberculosis clas- terms shall have the meanings set sification under this part than the rest forth in this section except as other- of the State. The requested zones must wise specified. be delineated by the State animal Accreditation preparatory State or zone. health authorities, subject to approval A State or zone that is or is part of a by the Administrator. The request State that has the authority to enforce from the State must demonstrate that and complies with the provisions of the the State complies with the following ‘‘Uniform Methods and Rules—Bovine requirements: Tuberculosis Eradication’’ and in (1) The State must have the legal and which tuberculosis is prevalent in less financial resources to implement and than 0.5 percent of the total number of enforce a tuberculosis eradication pro- herds of cattle and bison in the State gram and must have in place an infra- or zone. structure, laws, and regulations that Accredited-free State or zone. A State require and ensure that State and Fed- or zone that is or is part of a State that eral animal health authorities are noti- has the authority to enforce and com- fied of tuberculosis cases in domestic plies with the provisions of the ‘‘Uni- livestock or outbreaks in wildlife; form Methods and Rules—Bovine Tu- (2) The State in which the intended berculosis Eradication,’’ has zero per- zones are located must maintain, in cent prevalence of affected cattle and each intended zone, clinical and epi- bison herds, and has had no findings of demiologic surveillance of animal spe- tuberculosis in any cattle or bison

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herds in the State or zone for the pre- Modified accredited advanced State or vious 5 years. Except that: The require- zone. A State or zone that is or is part ment of freedom from tuberculosis in of a State that has the authority to en- herds is 2 years from the depopulation force and complies with the provisions of the last affected herd in States or of the ‘‘Uniform Methods and Rules— zones that were previously accredited Bovine Tuberculosis Eradication’’ and free and in which all herds affected in which tuberculosis has been preva- with tuberculosis were depopulated, 3 lent in less than 0.01 percent of the years in all other States or zones that total number of herds of cattle and have depopulated all affected herds, bison in the State or zone for each of and 3 years in States or zones that the most recent 2 years. Except that: have conducted surveillance that dem- The Administrator, upon his or her re- onstrates that other livestock herds view, may allow a State or zone with and wildlife are not at risk of being in- fewer than 30,000 herds to have up to 3 fected with tuberculosis, as determined affected herds for each of the most re- by the Administrator based on a risk cent 2 years, depending on the veteri- assessment conducted by APHIS. nary infrastructure, livestock demo- Accredited herd. To establish or main- graphics, and tuberculosis control and tain accredited herd status, the herd eradication measures in the State or owner must comply with all of the prozone. visions of the ‘‘Uniform Methods and Modified accredited State or zone. A Rules—Bovine Tuberculosis Eradi- State or zone that is or is part of a cation’’ regarding accredited herds. All State that has the authority to enforce cattle and bison in a herd must be free and complies with the provisions of the from tuberculosis. ‘‘Uniform Methods and Rules—Bovine Approved feedlot. A confined area ap- Tuberculosis Eradication’’ and in proved jointly by the State animal which tuberculosis has been prevalent in less than 0.1 percent of the total health official and the Administrator number of herds of cattle and bison in for feeding cattle and bison for slaugh- the State or zone for the most recent ter, with no provisions for pasturing or year. Except that: The Administrator, grazing. upon his or her review, may allow a A Approved slaughtering establishment. State or zone with fewer than 10,000 slaughtering establishment operating herds to have up to 10 affected herds under the provisions of the Federal for the most recent year, depending on Meat Inspection Act (21 U.S.C. 601 et the veterinary infrastructure, live- ) or a State-inspected slaughtering seq. stock demographics, and tuberculosis establishment that has inspection by a control and eradication measures in State inspector at the time of slaugh- the State or zone. ter. Negative cattle and bison. Cattle and Cattle and bison not known to be af- bison that are classified negative for fected. All cattle and bison except those tuberculosis in accordance with the originating from tuberculosis affected ‘‘Uniform Methods and Rules—Bovine herds or from herds containing tuber- Tuberculosis Eradication,’’ based on culosis suspect cattle or bison. the results of an official tuberculin Department. The U.S. Department of test. Agriculture (USDA). Nonaccredited State or zone. A State or Exposed cattle and bison. Cattle and zone that is or is part of a State that bison, except reactor cattle and bison, does not meet the standards of the that are part of an affected herd. ‘‘Uniform Methods and Rules—Bovine Feedlot. A facility for congregating Tuberculosis Eradication’’ or in which finished fed cattle prior to their being tuberculosis is prevalent in 0.5 percent shipped to slaughter. or more of the total number of herds of Finished fed cattle. Cattle fattened on cattle and bison in the State or zone. a ration of feed concentrates to reach a Official tuberculin test. Any test for slaughter condition equivalent to that tuberculosis conducted on cattle or which would be attained on full feed bison in accordance with the ‘‘Uniform with a high concentrate grain ration Methods and Rules—Bovine Tuber- for 90 days. culosis Eradication.’’

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Permit. An official document issued Zero percent prevalence. No finding of for movement of cattle or bison under tuberculosis in any cattle, bison, or this part by an APHIS representative, goat herd in a State or zone. State representative, or an accredited [65 FR 63517, Oct. 23, 2000, as amended at 70 veterinarian at the point of origin of a FR 61026, Oct. 20, 2005] shipment of cattle or bison to be moved directly to slaughter, that shows the § 77.6 Applicability of this subpart. tuberculosis status of each animal (re- All references in this subpart to the actor, suspect, or exposed), the eartag tuberculosis status of States and zones number of each animal and the name of pertain to such status for cattle and the owner of such animal, the estab- bison only. lishment to which the animals are to be moved, the purpose for which the § 77.7 Accredited-free States or zones. animals are to be moved, and that they (a) The following are accredited-free are eligible for such movement under States: Alabama, Alaska, Arizona, Ar- the applicable provisions of §§ 77.17 and kansas,Colorado, Connecticut, Dela- 77.18. ware, Florida, Georgia, Hawaii, Idaho, Quarantined feedlot. A confined area Illinois, Indiana, Iowa, Kansas, Ken- under the direct supervision and con- tucky, Louisiana, Maine, Maryland, trol of a State livestock official who Massachusetts, Minnesota, Mississippi, shall establish procedures for the ac- Missouri, Montana, Nebraska, Nevada, counting of all livestock entering or New Hampshire, New Jersey, New Mex- leaving the area. The quarantined feed- ico, New York, North Carolina, North lot shall be maintained for finish feed- Dakota, Ohio, Oklahoma, Oregon, ing of livestock in drylot with no pro- Pennsylvania, Puerto Rico, Rhode Is- vision for pasturing and grazing. All land, South Carolina, South Dakota, livestock leaving such feedlot must Tennessee, Texas, Utah, Vermont, Vir- only move directly to slaughter in ac- ginia, the Virgin Islands of the United cordance with established procedures States, Washington, West Virginia, for handling quarantined livestock. Wisconsin, and Wyoming. Reactor cattle and bison. Cattle and (b) The following are accredited-free bison that are classified as reactors for zones: tuberculosis in accordance with the (1) All of the State of Michigan ex- ‘‘Uniform Methods and Rules—Bovine cept for the zones that comprise those Tuberculosis Eradication.’’ counties in Michigan described in Suspect cattle and bison. Cattle and § 77.9(b)(1) and § 77.11(b)(1). bison that are classified as suspects for (2) [Reserved] tuberculosis in accordance with the (c) If an affected herd is detected in a ‘‘Uniform Methods and Rules—Bovine State or zone classified as accredited- Tuberculosis Eradication.’’ free, and the herd is depopulated and Uniform Methods and Rules—Bovine an epidemiologic investigation is com- Tuberculosis Eradication. Uniform meth- pleted within 90 days of the detection ods and rules for eradicating bovine tu- of the affected herd with no evidence of berculosis in the United States, ap- the spread of tuberculosis, the State or proved by APHIS on January 22, 1999, zone may retain its accredited-free sta- which is incorporated by reference at tus. If two or more affected herds are § 77.1. detected in an accredited-free State or zone within a 48-month period, the Whole herd test. An official tuberculin State or zone will be removed from the test of all cattle and bison in a herd list of accredited-free States or zones that are 12 months of age or older, and and will be reclassified as modified ac- of all cattle and bison in the herd that credited advanced. are less than 12 months of age and were (d) If any livestock other than cattle not born into the herd, except those or bison are included in a newly assem- cattle and bison that are less than 12 bled herd on a premises where a tuber- months of age and were born in and culous herd has been depopulated, the originated from an accredited herd. State or zone must apply the herd test

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requirements contained in the ‘‘Uni- § 77.8 Interstate movement from ac- form Methods and Rules—Bovine Tu- credited-free States and zones. berculosis Eradication’’ (January 22, Cattle or bison that originate in an 1999, edition), which is incorporated by accredited-free State or zone may be reference at § 77.1, to those other live- moved interstate without restriction. stock in the same manner as to cattle and bison. Failure to do so will result § 77.9 Modified accredited advanced in reclassification of the State or zone States or zones. as modified accredited advanced. (a) The following are modified ac- (e) If tuberculosis is diagnosed within credited advanced States: California. an accredited-free State or zone in an (b) The following are modified ac- animal not specifically regulated by credited advanced zones: this part and a risk assessment con- (1) A zone in Michigan that comprises ducted by APHIS determines that the Antrim, Charlevoix, Cheboygan, outbreak poses a tuberculosis risk to Crawford, Emmet, Otsego, and Presque livestock within the State or zone, the Isle Counties. State or zone must implement a tuber- (2) [Reserved] culosis management plan, approved (c) If any livestock other than cattle jointly by the State animal health offi- or bison are included in a newly assem- cial and the Administrator, within 6 bled herd on a premises where a tuber- months of the diagnosis. The manage- culous herd has been depopulated, the ment plan must include provisions for State or zone must apply the herd test immediate investigation of tuber- requirements contained in the ‘‘Uni- culosis in animals held for exhibition form Methods and Rules—Bovine Tu- and in livestock and wildlife; the pre- berculosis Eradication’’ (January 22, vention of the spread of the disease to 1999), which is incorporated by ref- other animals held for exhibition and erence at § 77.1, for such newly assem- to livestock and wildlife; increased sur- bled herds to those other livestock in veillance for tuberculosis in animals the same manner as to cattle and held for exhibition and wildlife; eradi- bison. Failure to do so will result in cation of tuberculosis from individual the removal of the State or zone from herds; a timeline for tuberculosis the list of modified accredited ad- eradication; and performance standards vanced States or zones and its being re- by which to measure yearly progress classified as modified accredited. toward eradication. If a State or zone (d) If tuberculosis is diagnosed within does not implement such a plan within a modified accredited advanced State the required 6 months, the State or or zone in an animal not specifically zone will lose its accredited-free status regulated by this part and a risk as- and will be reclassified as modified ac- sessment conducted by APHIS deter- credited advanced. mines that the outbreak poses a tuber- (f) Accredited-free State or zone sta- culosis risk to livestock within the tus must be renewed annually. To qual- State or zone, the State or zone must ify for renewal of accredited-free State implement a tuberculosis management or zone status, a State must submit an plan, approved jointly by the State ani- annual report to APHIS certifying that mal health official and the Adminis- the State or zone within the State trator, within 6 months of the diag- complies with the provisions of the nosis. The management plan must in- ‘‘Uniform Methods and Rules—Bovine clude provisions for immediate inves- Tuberculosis Eradication.’’ The report tigation of tuberculosis in animals held must be submitted to APHIS each year for exhibition and in livestock and between October 1 and November 30. wildlife; the prevention of the spread of (Approved by the Office of Management and the disease to other animals held for Budget under control number 0579–0146) exhibition and to livestock and wild- [65 FR 63517, Oct. 23, 2000] life; increased surveillance for tuberculosis in animals held for exhibition EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 77.7, see the List of CFR and wildlife; eradication of tuber- Sections Affected, which appears in the culosis from individual herds; a Finding Aids section of the printed volume timeline for tuberculosis eradication; and at www.fdsys.gov. and performance standards by which to

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measure yearly progress toward eradi- fected with or exposed to tuberculosis, cation. If a State or zone does not im- may be moved interstate only under plement such a plan within the re- one of the following conditions: quired 6 months, the State or zone will (a) The cattle or bison are moved di- be reclassified as modified accredited. rectly to slaughter at an approved (e) Modified accredited advanced slaughtering establishment. State or zone status must be renewed (b) The cattle or bison are sexually annually. To qualify for renewal of a intact heifers moved to an approved modified accredited advanced State or feedlot, or are steers or spayed heifers; zone status, a State must submit an and are either officially identified or annual report to APHIS certifying that identified by premises of origin identi- the State or zone complies with the fication. provisions of the ‘‘Uniform Methods (c) The cattle or bison are from an and Rules—Bovine Tuberculosis Eradi- accredited herd and are accompanied cation.’’ The report must be submitted by a certificate stating that the ac- to APHIS each year between October 1 credited herd completed the testing and November 30. necessary for accredited status with (f) To qualify for accredited-free sta- negative results within 1 year prior to tus, a modified accredited advanced the date of movement. State or zone must demonstrate to the (d) The cattle or bison are sexually Administrator that it complies with intact animals; are not from an accred- the provisions of the ‘‘Uniform Meth- ited herd; are officially identified; and ods and Rules—Bovine Tuberculosis are accompanied by a certificate stat- Eradication,’’ has zero percent preva- ing that they were negative to an offi- lence of affected cattle and bison herds, cial tuberculin test conducted within and has had no findings of tuberculosis 60 days prior to the date of movement. in any cattle or bison in the State or zone for the previous 5 years. Except (Approved by the Office of Management and that: The requirement of freedom from Budget under control numbers 0579–0146, tuberculosis is 2 years from the de- 0579–0220, and 0579–0229) population of the last affected herd in [65 FR 63517, Oct. 23, 2000, as amended at 68 States or zones that were previously FR 20336, Apr. 25, 2003; 68 FR 43621, July 24, accredited free and in which all herds 2003] affected with tuberculosis were depopulated, 3 years in all other States or § 77.11 Modified accredited States or zones that have depopulated all af- zones. fected herds, and 3 years in States or (a) The following are modified ac- zones that have conducted surveillance credited States: None. that demonstrates that other livestock (b) The following are modified ac- herds and wildlife are not at risk of credited zones: being infected with tuberculosis, as de- (1) A zone in Michigan that comprises termined by the Administrator based Alcona, Alpena, Montmorency, and on a risk assessment conducted by Oscoda Counties. APHIS. (2) [Reserved] (Approved by the Office of Management and (c) If any livestock other than cattle Budget under control number 0579–0146) or bison are included in a newly assem- [65 FR 63517, Oct. 23, 2000] bled herd on a premises where a tuberculous herd has been depopulated, the EDITORIAL NOTE: For FEDERAL REGISTER ci- State or zone must apply the herd test tations affecting § 77.9, see the List of CFR Sections Affected, which appears in the requirements contained in the ‘‘Uni- Finding Aids section of the printed volume form Methods and Rules—Bovine Tu- and at www.fdsys.gov. berculosis Eradication’’ (January 22, 1999, edition), which is incorporated by § 77.10 Interstate movement from reference at § 77.1, for such newly as- modified accredited advanced sembled herds to those other livestock States and zones. in the same manner as to cattle and Cattle or bison that originate in a bison. Failure to do so will result in modified accredited advanced State or the removal of the State or zone from zone, and that are not known to be in- the list of modified accredited States

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or zones and its being reclassified as 2 years, depending on the veterinary accreditation preparatory. infrastructure, livestock demo- (d) If tuberculosis is diagnosed within graphics, and tuberculosis control and a modified accredited State or zone in eradication measures in the State or an animal not specifically regulated by zone. this part and a risk assessment conducted by APHIS determines that the (Approved by the Office of Management and outbreak poses a tuberculosis risk to Budget under control number 0579–0146) livestock within the State or zone, the [65 FR 63517, Oct. 23, 2000; 65 FR 64479, Oct. 27, State or zone must implement a tuber- 2000, as amended at 69 FR 20809, Apr. 19, 2004; culosis management plan, approved 73 FR 19142, Apr. 9, 2008; 73 FR 60102, Oct. 10, jointly by the State animal health offi- 2008; 74 FR 67053, Dec. 18, 2009; 75 FR 60588, cial and the Administrator, within 6 Oct. 1, 2010; 76 FR 56636, Sept. 14, 2011] months of the diagnosis. The management plan must include provisions for § 77.12 Interstate movement from immediate investigation of tuber- modified accredited States and culosis in animals held for exhibition zones. and in livestock and wildlife; the pre- Cattle or bison that originate in a vention of the spread of the disease to modified accredited State or zone, and other animals held for exhibition and that are not known to be infected with to livestock and wildlife; increased sur- or exposed to tuberculosis, may be veillance for tuberculosis in animals moved interstate only under one of the held for exhibition and wildlife; eradi- following conditions: cation of tuberculosis from individual (a) The cattle or bison are moved di- herds; a timeline for tuberculosis rectly to slaughter at an approved eradication; and performance standards slaughtering establishment. by which to measure yearly progress (b) The cattle or bison are sexually toward eradication. If a State or zone intact heifers moved to an approved does not implement such a plan within feedlot, or are steers or spayed heifers; the required 6 months, the State or zone will be reclassified as accredita- are either officially identified or iden- tion preparatory. tified by premises of origin identifica- (e) Modified accredited State or zone tion; and are accompanied by a certifi- status must be renewed annually. To cate stating that they were classified qualify for renewal of a modified ac- negative to an official tuberculin test credited State or zone status, a State conducted within 60 days prior to the must submit an annual report to date of movement. APHIS certifying that the State or (c) The cattle or bison are from an zone complies with the provisions of accredited herd and are accompanied the ‘‘Uniform Methods and Rules—Bo- by a certificate stating that the ac- vine Tuberculosis Eradication.’’ The credited herd completed the testing report must be submitted to APHIS necessary for accredited status with each year between October 1 and No- negative results within 1 year prior to vember 30. the date of movement. (f) To qualify for modified accredited (d) The cattle or bison are sexually advanced status, a modified accredited intact animals; are not from an accred- State or zone must demonstrate to the ited herd; are officially identified; and Administrator that it complies with are accompanied by a certificate stat- the provisions of the ‘‘Uniform Meth- ing that the herd from which they ods and Rules—Bovine Tuberculosis originated was negative to a whole Eradication’’ and that tuberculosis has herd test conducted within 1 year prior been prevalent in less than 0.01 percent of the total number of herds of cattle to the date of movement and that the and bison in the State or zone for the individual animals to be moved were most recent 2 years. Except that: The negative to an additional official tu- Administrator, upon his or her review, berculin test conducted within 60 days may allow a State or zone with fewer prior to the date of movement, except than 30,000 herds to have up to 3 af- that the additional test is not required fected herds for each of the most recent if the animals are moved interstate

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within 60 days following the whole herd State or zone will be reclassified as test. nonaccredited. (e) Accreditation preparatory State (Approved by the Office of Management and or zone status must be renewed annu- Budget under control number 0579–0146) ally. To qualify for renewal of accredi- [65 FR 63517, Oct. 23, 2000, as amended at 70 tation preparatory State or zone sta- FR 29582, May 24, 2005] tus, a State must submit an annual report to APHIS certifying that the § 77.13 Accreditation preparatory State or zone complies with the provi- States or zones. sions of the ‘‘Uniform Methods and (a) The following are accreditation Rules—Bovine Tuberculosis Eradi- preparatory States: None. cation.’’ The report must be submitted (b) The following are accreditation to APHIS each year between October 1 preparatory zones: None. and November 30. (c) If any livestock other than cattle (f) To qualify for modified accredited or bison are included in a newly assem- status, an accreditation preparatory bled herd on a premises where a tuber- State or zone must demonstrate to the culous herd has been depopulated, the Administrator that it complies with State or zone must apply the herd test the provisions of the ‘‘Uniform Meth- requirements contained in the ‘‘Uni- ods and Rules—Bovine Tuberculosis form Methods and Rules—Bovine Tu- Eradication’’ and that tuberculosis has berculosis Eradication’’ (January 22, been prevalent in less than 0.1 percent 1999 edition), which is incorporated by of the total number of herds of cattle reference at § 77.1, for such newly as- and bison in the State or zone for the sembled herds to those other livestock most recent year. Except that: The Ad- in the same manner as to cattle and ministrator, upon his or her review, bison. Failure to do so will result in may allow a State or zone with fewer the removal of the State or zone from than 10,000 herds to have up to 10 af- the list of accreditation preparatory fected herds for the most recent year, States or zones and its being reclassi- depending on the veterinary infrastruc- fied as nonaccredited. ture, livestock demographics, and tu- (d) If tuberculosis is diagnosed within berculosis control and eradication an accreditation preparatory State or measures in the State or zone. zone in an animal not specifically regu- (Approved by the Office of Management and lated by this part and a risk assess- Budget under control number 0579–0146) ment conducted by APHIS determines that the outbreak poses a tuberculosis § 77.14 Interstate movement from ac- risk to livestock within the State or creditation preparatory States and zone, the State or zone must imple- zones. ment a tuberculosis management plan, Cattle or bison that originate in an approved jointly by the State animal accreditation preparatory State or health official and the Administrator, zone, and that are not known to be in- within 6 months of the diagnosis. The fected with or exposed to tuberculosis, management plan must include provi- may be moved interstate only under sions for immediate investigation of one of the following conditions: tuberculosis in animals held for exhi- (a) The cattle or bison are moved di- bition and in livestock and wildlife; the rectly to slaughter at an approved prevention of the spread of the disease slaughtering establishment. to other animals held for exhibition (b) The cattle or bison are sexually and to livestock and wildlife; increased intact heifers moved to an approved surveillance for tuberculosis in ani- feedlot, or are steers or spayed heifers; mals held for exhibition and wildlife; are officially identified or identified by eradication of tuberculosis from indi- a premises of origin identification; and vidual herds; a timeline for tuber- are accompanied by a certificate stat- culosis eradication; and performance ing that the herd from which they standards by which to measure yearly originated was negative to a whole progress toward eradication. If a State herd test conducted within 1 year prior or zone does not implement such a plan to the date of movement and that the within the required 6 months, the individual animals to be moved were

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negative to an additional official tu- § 77.16 Interstate movement from non- berculin test conducted within 60 days accredited States and zones. prior to the date of movement, except Cattle or bison that originate in a that the additional test is not required nonaccredited State or zone, and that if the animals are moved interstate are not known to be infected with or within 6 months following the whole exposed to tuberculosis, may be moved herd test. interstate only if the cattle or bison (c) The cattle or bison are from an are accompanied by VS Form 1–27 and accredited herd; are officially identi- are moved interstate for slaughter in fied; and are accompanied by a certifi- an officially sealed means of convey- cate stating that the accredited herd ance directly to an approved slaugh- completed the testing necessary for ac- tering establishment. credited status with negative results § 77.17 Interstate movement of cattle within 1 year prior to the date of move- and bison that are exposed, reac- ment and that the animals to be moved tors, or suspects, or from herds con- were negative to an official tuberculin taining suspects. test conducted within 60 days prior to (a) Reactor cattle and bison. Cattle or the date of movement. bison that have been classified as reac- (d) The cattle or bison are sexually tor cattle or bison may be moved inter- intact animals; are not from an accred- state only if they are moved directly to ited herd; are officially identified; and slaughter at an approved slaughtering are accompanied by a certificate stat- establishment and only in accordance ing that the herd from which they with the following conditions: originated was negative to a whole (1) Reactor cattle and bison must be herd test conducted within 1 year prior individually identified by attaching to to the date of movement and that the the left ear an approved metal eartag individual animals to be moved were bearing a serial number and the in- negative to two additional official tu- scription ‘‘U.S. Reactor,’’ or a similar berculin tests conducted at least 60 State reactor tag, and must be: days apart and no more than 6 months (i) Branded with the letter ‘‘T,’’ at apart, with the second test conducted least 5 by 5 centimeters (2 by 2 inches) within 60 days prior to the date of in size, high on the left hip near the movement, except that the second ad- tailhead; or ditional test is not required if the ani- (ii) Permanently identified with the mals are moved interstate within 60 letters ‘‘TB’’ tattooed legibly in the days following the whole herd test. left ear and sprayed with yellow paint on the left ear and either accompanied (Approved by the Office of Management and directly to slaughter by an APHIS or Budget under control number 0579–0146) State representative or moved directly [65 FR 63517, Oct. 23, 2000, as amended at 70 to slaughter in vehicles closed with of- FR 29582, May 24, 2005] ficial seals. Such official seals must be applied and removed by an APHIS rep- § 77.15 Nonaccredited States or zones. resentative, State representative, ac- (a) The following are nonaccredited credited veterinarian, or an individual authorized for this purpose by an States: None. APHIS representative. (b) The following are nonaccredited (2) The reactor cattle or bison must zones: None. be accompanied by a permit; and (c) To qualify for accreditation pre- (3) The reactor cattle or bison may paratory status, a nonaccredited State not be moved interstate in a means of or zone must demonstrate to the Ad- conveyance containing any animals ministrator that it complies with the susceptible to tuberculosis unless all of provisions of the ‘‘Uniform Methods the animals are being moved directly and Rules—Bovine Tuberculosis Eradi- to slaughter; and cation’’ and that tuberculosis is preva- (4) Any person who moves reactor lent in less than 0.5 percent of the total cattle or bison interstate under this number of herds of cattle and bison in paragraph must plainly write or stamp the State or zone. upon the face of the transportation

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document the words ‘‘Tuberculin Reac- graphs (a)(2), (a)(3), and (a)(5) of this tor’’ and the following statement: section. ‘‘This conveyance must be cleaned and (c) Suspect cattle and bison. Suspect disinfected in accordance with 9 CFR cattle or bison from herds in which no 77.17(a)(5).’’; and reactor cattle or bison have been dis- (5) Each means of conveyance in closed on an official tuberculin test, as which reactor cattle or bison have been well as negative cattle or bison from transported interstate under this para- such herds, may be moved interstate graph must be cleaned and disinfected only if they are moved directly to by the carrier, in accordance with the slaughter to an approved slaughtering provisions of §§ 71.6, 71.7, and 71.10 of establishment. this subchapter, under the supervision (Approved by the Office of Management and of an APHIS representative or State Budget under control number 0579–0051) representative or an accredited veterinarian or other person designated by § 77.18 Other movements. the Administrator. If, at the point where the cattle or bison are unloaded, The Administrator may, with the such supervision or proper cleaning and concurrence of the State animal health disinfecting facilities are not available, official of the State of destination, and permission is obtained from an upon request in specific cases, allow APHIS representative or State rep- the interstate movement of cattle or resentative, the empty means of con- bison not otherwise provided for in this veyance may be moved to a location part that have not been classified as re- where such supervision and facilities actor cattle or bison and are not other- are available for cleaning and dis- wise known to be affected with tuber- infecting. Permission will be granted if culosis, under such conditions as the such movement does not present a risk Administrator may prescribe in each specific case to prevent the spread of of disseminating tuberculosis. tuberculosis. The Administrator shall (b) Exposed cattle and bison. Except promptly notify the appropriate State for the movement of exposed cattle to animal health official of the State of a quarantined feedlot in accordance destination of any such action. with § 50.16 of this chapter, exposed cattle or bison may be moved interstate § 77.19 Cleaning and disinfection of only if they are moved directly to premises, conveyances, and mate- slaughter to an approved slaughtering rials. establishment and only in accordance All conveyances and associated with the following conditions: equipment, premises, and structures (1) Exposed cattle and bison must be that are used for receiving, holding, individually identified by attaching to shipping, loading, unloading, and deliv- either ear an approved metal eartag ering cattle or bison in connection bearing a serial number and must be: with their interstate movement and (i) Branded with the letter ‘‘S,’’ at that are determined by cooperating least 5 by 5 centimeters (2 by 2 inches) State and Federal animal health offi- in size, high on the left hip near the cials to be contaminated because of oc- tailhead; or cupation or use by tuberculous or reac- (ii) Accompanied directly to slaugh- tor livestock must be cleaned and dis- ter by an APHIS or State representa- infected under the supervision of the tive; or cooperating State or Federal animal (iii) Moved directly to slaughter in health officials. Such cleaning and dis- vehicles closed with official seals. Such infecting must be done in accordance official seals must be applied and re- with procedures approved by the co- moved by an APHIS representative, operating State or Federal animal State representative, accredited veteri- health officials. Cleaning and disinfec- narian, or an individual authorized for tion must be completed before the this purpose by an APHIS representa- premises, conveyances, or materials tive. may again be used to convey, hold, or (2) The exposed cattle and bison must in any way come in contact with any be moved in accordance with para- livestock.

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Subpart C—Captive Cervids state, during the period of time from capture until release into the wild. A § 77.20 Definitions. captive cervid that escapes will con- As used in subpart C, the following tinue to be considered a captive cervid terms shall have the meanings set as long as it bears an official eartag or forth in this section except as other- other identification approved by the wise specified. Administrator as unique and traceable Accreditation preparatory State or zone. with which to trace the animal back to A State or zone that is or is part of a its herd of origin. State that has the authority to enforce Comparative cervical tuberculin (CCT) and complies with the provisions of the test. The intradermal injection of bio- ‘‘Uniform Methods and Rules—Bovine logically balanced USDA bovine PPD Tuberculosis Eradication’’ and in tuberculin and avian PPD tuberculin which tuberculosis is prevalent in less at separate sites in the mid-cervical than 0.5 percent of the total number of area to determine the probable pres- herds of captive cervids in the State or ence of bovine tuberculosis (M. bovis) zone. by comparing the response of the two Accredited herd. A herd of captive tuberculins at 72 hours (plus or minus 6 cervids that has tested negative to at hours) following injection. least two consecutive official tuber- Designated accredited veterinarian. An culosis tests of all eligible captive accredited veterinarian who is trained cervids in accordance with § 77.33(f) and and approved by cooperating State and that meets the standards set forth in Federal animal health officials to con- § 77.35. The tests must be conducted at duct the single cervical tuberculin 9–15 month intervals. (SCT) test on captive cervids. Accredited-free State or zone. A State Exposed captive cervid. Any captive or zone that is or is part of a State that cervid that has been exposed to tuber- has the authority to enforce and com- culosis by reason of associating with plies with the provisions of the ‘‘Uni- captive cervids, cattle, bison, or other form Methods and Rules—Bovine Tu- livestock from which M. bovis has been berculosis Eradication,’’ has zero per- isolated. cent prevalence of affected captive Modified accredited State or zone. A cervid herds, and has had no findings of State or zone that is or is part of a tuberculosis in any captive cervid State that has the authority to enforce herds in the State or zone for the pre- and complies with the provisions of the vious 5 years. Except that: The require- ‘‘Uniform Methods and Rules—Bovine ment of freedom from tuberculosis in Tuberculosis Eradication’’ and in herds is 2 years from the depopulation which tuberculosis has been prevalent of the last affected herd in States or in less than 0.1 percent of the total zones that were previously accredited number of herds of captive cervids in free and in which all herds affected the State or zone for the most recent with tuberculosis were depopulated, 3 year. Except that: The Administrator, years in all other States or zones that upon his or her review, may allow a have depopulated all affected herds, State or zone with fewer than 10,000 and 3 years in States or zones that herds to have up to 10 affected herds have conducted surveillance that dem- for the most recent year, depending on onstrates that other livestock herds the veterinary infrastructure, live- and wildlife are not at risk of being in- stock demographics, and tuberculosis fected with tuberculosis, as determined control and eradication measures in by the Administrator based on a risk the State or zone. assessment conducted by APHIS. Modified accredited advanced State or Captive cervid. All species of deer, elk, zone. A State or zone that is or is part moose, and all other members of the of a State that has the authority to en- family Cervidae raised or maintained force and complies with the provisions in captivity for the production of meat of the ‘‘Uniform Methods and Rules— and other agricultural products, for Bovine Tuberculosis Eradication’’ and sport, or for exhibition, including time in which tuberculosis has been preva- such animals are moved interstate; or lent in less than 0.01 percent of the any wild cervid that is moved inter- total number of herds of captive

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cervids in the State or zone for the standard concentration of 1 mg protein most recent 2 years. Except that: The per 1 mL of solution. Administrator, upon his or her review, Qualified herd. A herd of captive may allow a State or zone with fewer cervids that has tested negative to at than 30,000 herds to have up to 3 af- least one official tuberculosis test of fected herds for each of the most recent all eligible captive cervids (see 2 years, depending on the veterinary § 77.33(f)) within the past 12 months and infrastructure, livestock demo- that is not classified as an accredited graphics, and tuberculosis control and herd. eradication measures in the State or Quarantine. Prohibition from inter- zone. state movement, except for slaughter Monitored herd. A herd on which iden- or necropsy. tification records are maintained on Reactor. Any captive cervid that captive cervids inspected for tuber- shows a response to the SCT test or the culosis at an approved slaughtering es- CCT test and is classified a reactor by tablishment or an approved diagnostic the testing veterinarian; or any sus- laboratory and on captive cervids test- pect captive cervid that is classified a ed for tuberculosis in accordance with reactor upon slaughter inspection or interstate movement requirements, necropsy after histopathology and/or and which meets the standards set culture of selected tissues by the USDA forth in § 77.37. or State veterinarian performing or su- Negative. Showing no response to the pervising the slaughter inspection or SCT test or the CCT test, or classified necropsy. negative for tuberculosis by the testing Regular-kill slaughter animal. An ani- veterinarian based upon history, sup- mal that is slaughtered for food or any plemental tests, examination of the reason other than because of a disease carcass, and histopathology and cul- regulated under 9 CFR chapter I (such ture of selected tissues. as tuberculosis, brucellosis, or any other livestock disease for which move- No gross lesions (NGL). Having no visi- ment of animals is restricted under 9 ble lesions indicative of bovine tuber- CFR chapter I). culosis detected upon necropsy or Single cervical tuberculin (SCT) test. slaughter inspection. The intradermal injection of 0.1 mL A State or Nonaccredited State or zone. (5,000 tuberculin units) of USDA PPD zone that is or is part of a State or bovis tuberculin in the mid-cervical zone that does not meet the standards area with a reading by visual observa- of the ‘‘Uniform Methods and Rules— tion and palpation at 72 hours (plus or Bovine Tuberculosis Eradication’’ or in minus 6 hours) following injection. which tuberculosis is prevalent in 0.5 Suspect. Any captive cervid that is percent or more of the total number of not negative to the SCT test or the herds of captive cervids in the State or CCT test and that is not classified as a zone. reactor by the testing veterinarian. Official tuberculosis test. Any of the Tuberculin. A product that is ap- following tests for bovine tuberculosis proved by and produced under USDA li- in captive cervids, applied and reported cense for injection into cervids and in accordance with this part: other animals for the purpose of de- (1) The single cervical tuberculin tecting bovine tuberculosis. (SCT) test. Tuberculous. Having lesions indic- (2) The comparative cervical tuber- ative of tuberculosis, infected with tu- culin test (CCT) test. berculosis based on isolation of M. Permit. An official document issued bovis, or being from a herd in which M. by a representative of APHIS, a State bovis has been isolated. representative, or an accredited veteri- USDA. The United States Depart- narian that must accompany any reac- ment of Agriculture. tor, suspect, or exposed captive cervid Whole herd test. An official tuber- moved interstate. culosis test of all captive cervids in a Purified protein derivative (PPD). Pro- herd that are 12 months of age or older, tein extract from an M. bovis culture and of all captive cervids in the herd that is resuspended in solution at a that are less than 12 months of age and

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were not born into the herd, except culosis management plan, approved those captive cervids that are less than jointly by the State animal health offi- 12 months of age and were born in and cial and the Administrator, within 6 originated from an accredited herd. months of the diagnosis. The manage- Zero percent prevalence. No finding of ment plan must include provisions for tuberculosis in any herd of captive immediate investigation of tuber- cervids in a State or zone. culosis in animals held for exhibition and in livestock and wildlife; the pre- [65 FR 63517, Oct. 23, 2000, as amended at 70 FR 61026, Oct. 20, 2005; 71 FR 24805, Apr. 27, vention of the spread of the disease to 2006] other animals held for exhibition and to livestock and wildlife; increased sur- § 77.21 Applicability of this subpart. veillance for tuberculosis in animals All references in this subpart to the held for exhibition and wildlife; eradi- tuberculosis status of States and zones cation of tuberculosis from individual pertain to such status for captive herds; a timeline for tuberculosis cervids. eradication; and performance standards by which to measure yearly progress § 77.22 Accredited-free States or zones. toward eradication. If a State or zone (a) The following are accredited-free does not implement such a plan within States: None. the required 6 months, the State or (b) The following are accredited-free zone will lose its accredited-free status zones: None. and will be reclassified as modified ac- (c) If an affected herd is detected in a credited advanced. State or zone classified as accredited- (f) Accredited-free State or zone sta- free, and the herd is depopulated and a tus must be renewed annually. To qual- complete epidemiologic investigation ify for renewal of accredited-free State is completed within 120 days of the de- or zone status, a State must submit an tection of the affected herd with no annual report to APHIS certifying that evidence of the spread of tuberculosis, the State or zone within the State the State or zone may retain its ac- complies with the provisions of the credited-free status. If two or more af- ‘‘Uniform Methods and Rules—Bovine fected herds are detected in an accred- Tuberculosis Eradication.’’ The report ited-free State or zone within a 48- must be submitted to APHIS each year month period, the State or zone will be between October 1 and November 30. removed from the list of accredited- (Approved by the Office of Management and free States or zones and will be reclas- Budget under control number 0579–0146) sified as modified accredited advanced. (d) If any livestock other than cap- § 77.23 Interstate movement from active cervids are included in a newly as- credited-free States and zones. sembled herd on a premises where a tu- Notwithstanding any other provi- berculous herd has been depopulated, sions of this part, captive cervids that the State or zone must apply the herd originate in an accredited-free State or test requirements contained in the zone may be moved interstate without ‘‘Uniform Methods and Rules—Bovine restriction. Tuberculosis Eradication’’ (January 22, 1999 edition), which is incorporated by § 77.24 Modified accredited advanced reference at § 77.1, to those other live- States or zones. stock in the same manner as to captive (a) The following are modified ac- cervids. Failure to do so will result in credited advanced States: None. reclassification of the State or zone as (b) The following are modified ac- modified accredited advanced. credited advanced zones: None. (e) If tuberculosis is diagnosed within (c) If any livestock other than cap- an accredited-free State or zone in an tive cervids are included in a newly as- animal not specifically regulated by sembled herd on a premises where a tu- this part and a risk assessment con- berculous herd has been depopulated, ducted by APHIS determines that the the State or zone must apply the herd outbreak poses a tuberculosis risk to test requirements contained in the livestock within the State or zone, the ‘‘Uniform Methods and Rules—Bovine State or zone must implement a tuber- Tuberculosis Eradication’’ (January 22,

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1999 edition), which is incorporated by Eradication,’’ has zero percent preva- reference at § 77.1, for such newly as- lence of affected captive cervid herds, sembled herds to those other livestock and has had no findings of tuberculosis in the same manner as to captive in any captive cervids in the State or cervids. Failure to do so will result in zone for the previous 5 years. Except the removal of the State or zone from that: The requirement of freedom from the list of modified accredited ad- tuberculosis is 2 years from the de- vanced States or zones and its being repopulation of the last affected herd in classified as modified accredited. States or zones that were previously (d) If tuberculosis is diagnosed within accredited-free and in which all herds a modified accredited advanced State affected with tuberculosis were depopu- or zone in an animal not specifically regulated by this part and a risk as- lated, 3 years in all other States or sessment conducted by APHIS deter- zones that have depopulated all af- mines that the outbreak poses a tuber- fected herds, and 3 years in States or culosis risk to livestock within the zones that have conducted surveillance State or zone, the State or zone must that demonstrates that other livestock implement a tuberculosis management herds and wildlife are not at risk of plan, approved jointly by the State ani- being infected with tuberculosis, as de- mal health official and the Adminis- termined by the Administrator based trator, within 6 months of the diag- on a risk assessment conducted by nosis. The management plan must in- APHIS. clude provisions for immediate investigation of tuberculosis in animals held (Approved by the Office of Management and for exhibition and in livestock and Budget under control number 0579–0146) wildlife; the prevention of the spread of § 77.25 Interstate movement from the disease to other animals held for modified accredited advanced exhibition and to livestock and wild- States and zones. life; increased surveillance for tuberculosis in animals held for exhibition Captive cervids that originate in a and wildlife; eradication of tuber- modified accredited advanced State or culosis from individual herds; a zone, and that are not known to be in- timeline for tuberculosis eradication; fected with or exposed to tuberculosis, and performance standards by which to may be moved interstate only under measure yearly progress toward eradi- one of the following conditions: cation. If a State or zone does not im- (a) The captive cervids are moved di- plement such a plan within the re- rectly to slaughter at an approved quired 6 months, the State or zone will slaughtering establishment. be reclassified as modified accredited. (b) The captive cervids are from an (e) Modified accredited advanced accredited herd, qualified herd, or mon- State or zone status must be renewed itored herd; are officially identified; annually. To qualify for renewal of a and are accompanied by a certificate modified accredited advanced State or stating that the herd completed the re- zone status, a State must submit an quirements for accredited herd, quali- annual report to APHIS certifying that the State or zone complies with all the fied herd, or monitored herd status provisions of the ‘‘Uniform Methods within 24 months prior to the date of and Rules—Bovine Tuberculosis Eradi- movement. cation’’ regarding modified accredited (c) The captive cervids are officially advanced States. The report must be identified and are accompanied by a submitted to APHIS each year between certificate stating that they were nega- October 1 and November 30. tive to an official tuberculin test con- (f) To qualify for accredited-free sta- ducted within 90 days prior to the date tus, a modified accredited advanced of movement. State or zone must demonstrate to the (Approved by the Office of Management and Administrator that it complies with Budget under control number 0579–0146) the provisions of the ‘‘Uniform Meth- ods and Rules—Bovine Tuberculosis

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§ 77.26 Modified accredited States or an animal not specifically regulated by zones. this part and a risk assessment con- (a) States listed in paragraph (b) of ducted by APHIS determines that the this section must submit to APHIS 1 by outbreak poses a tuberculosis risk to October 23, 2001 data demonstrating livestock within the State or zone, the that the State complies with the UMR State or zone must implement a tuber- or the State will be redesignated as culosis management plan, approved nonaccredited. If a State does submit jointly by the State animal health offi- surveillance data by October 23, 2001 cial and the Administrator, within 6 that meets the UMR standards, and months of the diagnosis. The manage- that APHIS believes qualifies the State ment plan must include provisions for for a classification other than modified immediate investigation of tuber- accredited, APHIS will initiate rule- culosis in animals held for exhibition making to change the State’s classi- and in livestock and wildlife; the pre- fication. vention of the spread of the disease to (b) The following are modified ac- other animals held for exhibition and credited States: Alabama, Alaska, Ari- to livestock and wildlife; increased sur- zona, Arkansas, California, Colorado, veillance for tuberculosis in animals Connecticut, Delaware, Florida, Geor- held for exhibition and wildlife; eradi- gia, Hawaii, Idaho, Illinois, Indiana, cation of tuberculosis from individual Iowa, Kansas, Kentucky, Louisiana, herds; a timeline for tuberculosis Maine, Maryland, Massachusetts, eradication; and performance standards Michigan, Minnesota, Mississippi, Mis- by which to measure yearly progress souri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mex- toward eradication. If a State or zone ico, New York, North Carolina, North does not implement such a plan within Dakota, Ohio, Oklahoma, Oregon, the required 6 months, the State or Pennsylvania, Puerto Rico, Rhode Is- zone will be reclassified as accredita- land, South Carolina, South Dakota, tion preparatory. Tennessee, Texas, Utah, Vermont, the (f) Modified accredited State or zone Virgin Islands of the United States, status must be renewed annually. To Virginia, Washington, West Virginia, qualify for renewal of a modified ac- Wisconsin, and Wyoming. credited State or zone status, a State (c) The following are modified ac- must submit an annual report to credited zones: None. APHIS certifying that the State or (d) If any livestock other than cap- zone complies with the provisions of tive cervids are included in a newly as- the ‘‘Uniform Methods and Rules—Bo- sembled herd on a premises where a tu- vine Tuberculosis Eradication.’’ The berculous herd has been depopulated, report must be submitted to APHIS the State or zone must apply the herd each year between October 1 and No- test requirements contained in the vember 30. ‘‘Uniform Methods and Rules—Bovine (g) To qualify for modified accredited Tuberculosis Eradication’’ (January 22, advanced status, a modified accredited 1999, edition), which is incorporated by State or zone must demonstrate to the reference at § 77.1, for such newly as- Administrator that it complies with sembled herds to those other livestock the provisions of the ‘‘Uniform Meth- in the same manner as to captive ods and Rules—Bovine Tuberculosis cervids. Failure to do so will result in Eradication’’ and that tuberculosis has the removal of the State or zone from been prevalent in less than 0.01 percent the list of modified accredited States of the total number of captive cervids or zones and its being reclassified as accreditation preparatory. in the State or zone for the most re- (e) If tuberculosis is diagnosed within cent 2 years. Except that: The Adminis- a modified accredited State or zone in trator, upon his or her review, may allow a State or zone with fewer than 30,000 herds to have up to 3 affected 1 Send the information to National Animal Health Programs, Veterinary Services, herds for each of the most recent 2 APHIS, 4700 River Road, Unit 42, Riverdale, years, depending on the veterinary in- Maryland 20737–1231. frastructure, livestock demographics,

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and tuberculosis control and eradi- Tuberculosis Eradication’’ (January 22, cation measures in the State or zone. 1999, edition), which is incorporated by reference at § 77.1, for such newly as- (Approved by the Office of Management and Budget under control number 0579–0146) sembled herds to those other livestock in the same manner as to captive § 77.27 Interstate movement from cervids. Failure to do so will result in modified accredited States and the removal of the State or zone from zones. the list of accreditation preparatory Except for captive cervids from a States or zones and its being reclassi- qualified herd or monitored herd, as fied as nonaccredited. provided in §§ 77.36 and 77.37, respec- (d) If tuberculosis is diagnosed within tively, captive cervids that originate in an accreditation preparatory State or a modified accredited State or zone, zone in an animal not specifically regu- and that are not known to be infected lated by this part and a risk assess- with or exposed to tuberculosis, may be ment conducted by APHIS determines moved interstate only under one of the that the outbreak poses a tuberculosis following conditions: risk to livestock within the State or (a) The captive cervids are moved di- zone, the State or zone must imple- rectly to slaughter at an approved ment a tuberculosis management plan, slaughtering establishment. approved jointly by the State animal (b) The captive cervids are from an health official and the Administrator, accredited herd and are accompanied within 6 months of the diagnosis. The by a certificate stating that the ac- management plan must include provi- credited herd completed the testing sions for immediate investigation of necessary for accredited status with tuberculosis in animals held for exhi- negative results within 24 months prior bition and in livestock and wildlife; the to the date of movement. prevention of the spread of the disease (c) The captive cervids are sexually to other animals held for exhibition intact animals; are not from an accred- and to livestock and wildlife; increased ited herd; are officially identified; and surveillance for tuberculosis in ani- are accompanied by a certificate stat- mals held for exhibition and wildlife; ing that the herd from which they eradication of tuberculosis from indi- originated was negative to a whole vidual herds; a timeline for tuber- herd test conducted within 1 year prior culosis eradication; and performance to the date of movement and that the standards by which to measure yearly individual animals to be moved were progress toward eradication. If a State negative to an additional official tu- or zone does not implement such a plan berculin test conducted within 90 days within the required 6 months, the prior to the date of movement, except State or zone will be reclassified as that the additional test is not required nonaccredited. if the animals are moved interstate (e) Accreditation preparatory State within 6 months following the whole or zone status must be renewed annu- herd test. ally. To qualify for renewal of accredi- (Approved by the Office of Management and tation preparatory State or zone sta- Budget under control number 0579–0146) tus, a State must submit an annual report to APHIS certifying that the § 77.28 Accreditation preparatory State or zone complies with the provi- States or zones. sions of the ‘‘Uniform Methods and (a) The following are accreditation Rules—Bovine Tuberculosis Eradi- preparatory States: None. cation.’’ The report must be submitted (b) The following are accreditation to APHIS each year between October 1 preparatory zones: None. and November 30. (c) If any livestock other than cap- (f) To qualify for modified accredited tive cervids are included in a newly as- status, an accreditation preparatory sembled herd on a premises where a tu- State or zone must demonstrate to the berculous herd has been depopulated, Administrator that it complies with the State or zone must apply the herd the provisions of the ‘‘Uniform Meth- test requirements contained in the ods and Rules—Bovine Tuberculosis ‘‘Uniform Methods and Rules—Bovine Eradication’’ and that tuberculosis has

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been prevalent in less than 0.1 percent mals are moved interstate within 6 of the total number of herds of captive months following the whole herd test. cervids in the State or zone for the (Approved by the Office of Management and most recent year. Except that: The Ad- Budget under control number 0579–0146) ministrator, upon his or her review, may allow a State or zone with fewer § 77.30 Nonaccredited States or zones. than 10,000 herds to have up to 10 af- (a) The following are nonaccredited fected herds for the most recent year, States: None. depending on the veterinary infrastruc- (b) The following are nonaccredited ture, livestock demographics, and tu- zones: None. berculosis control and eradication (c) To qualify for accreditation pre- measures in the State or zone. paratory status, a nonaccredited State (Approved by the Office of Management and or zone must demonstrate to the Ad- Budget under control number 0579–0146) ministrator that it complies with the provisions of the ‘‘Uniform Methods § 77.29 Interstate movement from ac- and Rules—Bovine Tuberculosis Eradi- creditation preparatory States and cation’’ and that tuberculosis is preva- zones. lent in less than 0.5 percent of the total number of herds of captive cervids in Except for captive cervids from a the State or zone. qualified herd or monitored herd, as provided in §§ 77.36 and 77.37, respec- § 77.31 Interstate movement from non- tively, captive cervids that originate in accredited States and zones. an accreditation preparatory State or Captive cervids that originate in a zone, and that are not known to be in- nonaccredited State or zone and that fected with or exposed to tuberculosis, are not known to be infected with or may be moved interstate only under exposed to tuberculosis may not be one of the following conditions: moved interstate only if they are ac- (a) The captive cervids are moved di- companied by VS Form 1–27 and are rectly to slaughter at an approved moved interstate in an officially sealed slaughtering establishment. means of conveyance directly to (b) The captive cervids are from an slaughter at an approved slaughtering accredited herd; are officially identi- establishment. fied; and are accompanied by a certificate stating that the accredited herd § 77.32 General restrictions. completed the testing necessary for ac- (a) Except for movement from accredited status with negative results credited-free States and zones in ac- within 24 months prior to the date of cordance with § 77.23, movement from movement and that the individual ani- accredited herds in accordance with mals to be moved were negative to an § 77.35, and movement to slaughter in official tuberculin test conducted with- accordance with §§ 77.25(a), 77.27(a), in 90 days prior to the date of move- 77.29(a), and 77.31(d), no captive cervid ment. may be moved interstate unless it has (c) The captive cervids are sexually been tested using an official tuber- intact animals; are not from an accred- culosis test, and it is moved in compli- ited herd; are officially identified; and ance with this part. are accompanied by a certificate stat- (b) No captive cervid with a response ing that the herd from which they to any official tuberculosis test is eli- originated was negative to a whole gible for interstate movement unless herd test conducted within 1 year prior the captive cervid subsequently tests to the date of movement and that the negative to a supplemental official tu- individual animals to be moved were berculosis test or is moved interstate negative to two additional official tu- directly to slaughter or necropsy in ac- berculin tests conducted at least 90 cordance with § 7.40. days apart and no more than 6 months (c) Except for captive cervids moving apart, with the second test conducted interstate under permit directly to within 90 days prior to the date of slaughter or necropsy under § 77.40, movement, except that the second ad- each captive cervid or shipment of cap- ditional test is not required if the ani- tive cervids to be moved interstate

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must be accompanied by a certificate River Road Unit 43, Riverdale, MD issued within 30 days of the movement 20737–1231. by a State or Federal animal health of- (d) Reporting of tests—(1) SCT and CCT ficial or an accredited veterinarian. tests. For the SCT and CCT tests, the (d) Captive cervids in zoological testing veterinarian must submit a re- parks that have been accredited by the port to cooperating State and Federal American Zoo and Aquarium Associa- animal health officials of the State in tion (AZA) are exempt from the regula- which the captive cervid is tested. The tions in this part when the captive report must include the following in- cervids are moved directly interstate formation for all SCT and CCT tests between AZA member facilities. Any administered: The number of the indi- captive cervids moved interstate that vidual eartag or other identification are not moved directly from an AZA approved by the Administrator; the member facility to another AZA mem- age, sex, and breed of each captive ber facility must be moved in accord- cervid tested; a record of all responses; ance with the regulations in this sub- the size of each response for the CCT part. test; and the test interpretation. (2) [Reserved] § 77.33 Testing procedures for tuber- (e) Test interpretation.(1) Interpreta- culosis in captive cervids. tion of an SCT test will be based upon (a) Approved testers. Except as ex- the judgment of the testing veteri- plained in paragraph (a)(1) of this sec- narian after observation and palpation tion, official tuberculosis tests may of the injection site, in accordance only be given by a veterinarian em- with the classification requirements ployed by the State in which the test is described in § 77.34(a). administered or by a veterinarian em- (2) Interpretation of a CCT test will ployed by USDA. be in accordance with the classifica- (1) A designated accredited veteri- tion requirements described in narian may conduct the SCT test, ex- § 77.34(b). cept as provided in § 77.34(a)(2) and (3) [Reserved] § 77.39(e) and (f). (f) Captive cervids eligible for testing. (2) [Reserved] Except as provided in § 77.35(a)(1) and (b) Approved diagnostic laboratories. (1) § 77.36(a)(1), testing of herds for indi- With one exception, histopathology vidual herd classification must include and culture results for all tuberculosis all captive cervids 1 year of age or over diagnoses will be accepted only from and any captive cervids other than nat- the National Veterinary Services Lab- ural additions (captive cervids born oratories (NVSL) in Ames, IA. The ex- into the herd) under 1 year of age. ception is that results will be accepted [65 FR 63517, Oct. 23, 2000, as amended at 71 from a laboratory of the Food Safety FR 24806, Apr. 27, 2006] and Inspection Service, USDA, for tissue examination of regular-kill slaugh- § 77.34 Official tuberculosis tests. ter animals in those cases where no (a) Single cervical tuberculin (SCT) test. submission is made to NVSL. (1) The SCT test is the primary test to (2) [Reserved] be used in individual captive cervids (c) Identification. Any captive cervid and in herds of unknown tuberculous tested with an official tuberculosis test status. Each captive cervid that re- must bear official identification in the sponds to the SCT test must be classi- form of an official eartag, or another fied as a suspect until it is retested identification device or method ap- with the CCT test and is either found proved by the Administrator as unique negative for tuberculosis or is classi- and traceable, at the time of the offi- fied as a reactor, unless, with the ex- cial tuberculosis test. Use of any iden- ception of a designated accredited vet- tification device or method other than erinarian, the testing veterinarian de- an official eartag must first be ap- termines that the captive cervid should proved by the Administrator as unique be classified as a reactor based on its and traceable. Written requests for ap- response to the SCT test. A designated proval must be sent to National Ani- accredited veterinarian must classify a mal Health Programs, VS, APHIS, 4700 responding captive cervid as a suspect,

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unless the DTE determines, based on (i) It has a response to the bovine epidemiological evidence, that the cap- PPD tuberculin that is greater than 2 tive cervid should be classified as a re- mm and that is at least 0.5 mm greater actor. than the response to the avian PPD tu- (2) The SCT test is the primary test berculin; or to be used in affected herds and in (ii) It has been classified as a suspect herds that have received captive on two successive CCT tests. cervids from an affected herd. When (iii) Any exceptions to reactor classi- used with affected herds or in herds fication under the conditions in para- that have received captive cervids from graph (b)(4)(i) and (b)(4)(ii) of this sec- an affected herd, the SCT test may tion must be justified by the testing only be administered by a veterinarian veterinarian in writing and have the employed by the State in which the concurrence of the DTE. test is administered or employed by USDA. In affected herds or herds that [65 FR 63517, Oct. 23, 2000, as amended at 71 have received captive cervids from an FR 24806, Apr. 27, 2006] affected herd, each captive cervid that responds to the SCT test must be clas- § 77.35 Interstate movement from ac- sified as a reactor, unless the DTE de- credited herds. termines that the captive cervid should (a) Qualifications. To be recognized as be classified as a suspect because of an accredited herd: possible exposure to a tuberculous ani- (1) All captive cervids in the herd eli- mal. gible for testing in accordance with (b) Comparative cervical tuberculin § 77.33(f) must have tested negative to (CCT) test. (1) The CCT test is a supple- at least two consecutive official tuber- mental test that may only be used for culosis tests, conducted at 9–15 month retesting captive cervids classified as intervals. However, captive cervids suspects. The CCT test may be used in under 1 year of age that are not natural affected herds only after the herd has additions to the herd do not have to be tested negative to at least two whole tested if they were born in and origi- herd SCT tests and only with the prior nate from an accredited herd. written consent of the DTE. The CCT (2) The owner of the herd must have test may not be used as a primary test a document issued by cooperating for herds of unknown tuberculous sta- State or Federal animal health offi- tus. cials stating that the herd has met the (2) A captive cervid tested with the requirements in paragraph (a)(1) of this CCT test must be classified as negative section and is classified as an accred- if it has a response to the bovine PPD tuberculin that is less than 1 mm. ited herd. (3) Unless the testing veterinarian (b) Movement allowed. Except as pro- determines that the captive cervid vided in § 77.23 with regard to captive should be classified as a reactor be- cervids that originate in an accredited- cause of possible exposure to a tuber- free State or zone, and except as pro- culous animal, a captive cervid tested vided in § 77.31 with regard to captive with the CCT test must be classified as cervids that originate in a nonaccred- a suspect if: ited State or zone, a captive cervid (i) It has a response to the bovine from an accredited herd may be moved PPD tuberculin that is greater than 2 interstate without further tuberculosis mm and that is equal to the response testing only if it is accompanied by a to the avian PPD tuberculin; or certificate, as provided in § 77.32(c), (ii) It has a response to the bovine that includes a statement that the cap- PPD tuberculin that is equal to or tive cervid is from an accredited herd. greater than 1mm and equal to or less If a group of captive cervids from an than 2mm and that is equal to or great- accredited herd is being moved inter- er than the response to the avian PPD state together to the same destination, tuberculin. all captive cervids in the group may be (4) A captive cervid tested with the moved under one certificate. CCT test must be classified as a reactor (c) Herd additions allowed. No captive if: cervid may be added to an accredited

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herd except in accordance with para- the accredited herd for purposes of graphs (c)(4) and (c)(5), and either para- interstate movement until they have graph (c)(1), (c)(2), or (c)(3) of this sec- tested negative to an official tuber- tion, as follows: culosis test and have been released (1) The captive cervid to be added from isolation. must be moved directly from an ac- (4) A captive cervid to be added must credited herd; not have been exposed during the 90 (2) The captive cervid to be added days prior to its movement to either: must be moved directly from a quali- (i) A captive cervid from a herd with fied or monitored herd and must have a lower classification status than its tested negative to an official tuber- own; or culosis test conducted within 90 days (ii) Any tuberculous livestock. prior to movement to the premises of (d) Maintenance of accredited herd sta- the accredited herd. Any captive cervid tus. To maintain status as an accred- moved from a qualified or monitored ited herd, the herd must test negative herd must also be isolated from all to an official tuberculosis test within members of the accredited herd until it 33–39 months from the anniversary date tests negative to an official tuber- of the second consecutive test with no culosis test conducted at least 90 days evidence of tuberculosis disclosed (that following the date of arrival at the is, the test on which the herd was rec- premises of the accredited herd. If a ognized as accredited or the accred- group of captive cervids is being moved iting test). Each time the herd is tested together, the entire group must be iso- for reaccreditation, it must be tested lated from all other livestock during 33–39 months from the anniversary date the testing period, but captive cervids of the accrediting test, not from the in the group need not be isolated from last date of reaccreditation (for exam- each other during that period. Such ple, if a herd is accredited on January herd additions will not receive status 1 of a given year, the anniversary date as members of the accredited herd for will be January 1 of every third year). purposes of interstate movement until Accredited herd status is valid for 36 they have tested negative to an official months (1,095 days) from the anniver- tuberculosis test and have been re- sary date of the accrediting test. If the leased from isolation; or herd is tested between 36 and 39 months (3) If the captive cervid to be added is after the anniversary date, its accred- not being moved directly from a classi- ited herd status will be suspended for fied herd, the captive cervid must be the interim between the anniversary isolated from all other members of the date and the reaccreditation test. Dur- herd of origin and must test negative ing the suspension period, the herd will to two official tuberculosis tests. The be considered ‘‘unclassified’’ and cap- isolation must begin at the time of the tive cervids may be moved interstate first official tuberculosis test. The from the herd only in accordance with tests must be conducted at least 90 the movement requirements for the days apart, and the second test must be State or zone in which the herd is lo- conducted within 90 days prior to cated. movement to the premises of the ac- [65 FR 63517, Oct. 23, 2000, as amended at 71 credited herd. The captive cervid must FR 24806, Apr. 27, 2006] also be isolated from all members of the accredited herd until it tests nega- § 77.36 Interstate movement from tive to an official tuberculosis test qualified herds. conducted at least 90 days following (a) Qualifications. To be recognized as the date of arrival at the premises of a qualified herd: the accredited herd. If a group of cap- (1) All captive cervids in the herd eli- tive cervids is being moved together, gible for testing in accordance with the entire group must be isolated from § 77.33(f) must have tested negative to all other animals during the testing pe- one official tuberculosis test that was riod, but captive cervids in the group administered to the herd within a 7- need not be isolated from each other month period. However, captive cervids during that period. Such herd additions under 1 year of age that are not natural will not receive status as members of additions do not have to be tested if

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they were born in and originate from cludes a statement that the captive an accredited, qualified, or monitored cervid is from a qualified herd and will herd. otherwise meet the requirements of (2) The owner of the herd must have this paragraph. a document issued by cooperating (c) Herd additions allowed. No captive State and Federal animal health offi- cervid may be added to a qualified herd cials stating that the herd has met the except in accordance with paragraph requirement in paragraph (a)(1) of this (c)(4) and either paragraph (c)(1), (c)(2), section and is classified as a qualified or (c)(3) of this section, as follows: herd. (1) The captive cervid to be added (b) Movement allowed. Except as pro- must be moved directly from an ac- vided in § 77.23 with regard to captive credited herd; cervids that originate in an accredited- (2) The captive cervid to be added free State or zone, and except as pro- must be moved directly from a quali- vided in § 77.31 with regard to captive fied or monitored herd and must have cervids that originate in a nonaccred- tested negative to an official tuber- ited State or zone, a captive cervid culosis test conducted within 90 days from a qualified herd may be moved prior to movement to the premises of interstate only if: the accredited herd; (1) The captive cervid is not known (3) If the captive cervid to be added is to be infected with or exposed to tuber- not being moved directly from a classi- culosis; and fied herd, the captive cervid must be (2) The captive cervid is accompanied isolated from all other animals in its by a certificate, as provided in herd of origin and must test negative § 77.32(c), that includes a statement to two official tuberculosis tests prior that the captive cervid is from a quali- to movement. The isolation must begin fied herd. Except as provided in para- at the time of the first official tuber- graphs (b)(3) and (b)(4) of this section, culosis test. The tests must be con- the certificate must also state that the ducted at least 90 days apart, and the captive cervid has tested negative to second test must be conducted within an official tuberculosis test conducted 90 days prior to movement to the prem- within 90 days prior to the date of ises of the qualified herd. The captive movement. If a group of captive cervids cervid must then be kept in isolation from a qualified herd is being moved from all animals until it tests negative interstate together to the same des- to an official tuberculosis test con- tination, all captive cervids in the ducted at least 90 days following the group may be moved under one certifi- date of arrival at the premises of the cate. qualified herd. If a group of captive (3) Captive cervids under 1 year of cervids is being moved together, the age that are natural additions to the entire group must be isolated from all qualified herd or that were born in and other livestock during the testing pe- originate from a classified herd may riod, but captive cervids in the group move without testing, provided that need not be isolated from each other the certificate accompanying them during that period. Such herd additions states that the captive cervids are nat- will not receive status as members of ural additions to the qualified herd or the qualified herd for purposes of inter- were born in and originated from a state movement until they have tested classified herd and have not been ex- negative to an official tuberculosis test posed to captive cervids from an un- and been released from isolation. classified herd. (4) A captive cervid to be added must (4) Captive cervids being moved not have been exposed during the 90 interstate for the purpose of exhibition days prior to its movement to either: only may be moved without testing, (i) A captive cervid from a herd with provided they are returned to the a lower classification status than its premises of origin no more than 90 days own; or after leaving the premises, have no (ii) Any tuberculous livestock. contact with other livestock during (d) Maintenance of qualified herd sta- movement and exhibition, and are ac- tus. To maintain status as a qualified companied by a certificate that in- herd, the herd must test negative to an

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official tuberculosis test within 9–15 imum number of 178 captive cervids months from the anniversary date of must be slaughter inspected or tested the first test with no evidence of tuber- for interstate movement over a 3-year culosis disclosed (this is the qualifying period to meet this requirement. test). Each time the herd is retested for (b) Movement allowed. Except as pro- qualified status, it must be tested 9–15 vided in § 77.23 with regard to captive months from the anniversary date of cervids that originate in an accredited- the qualifying test, not from the last free State or zone, and except as pro- date of requalification (for example, if vided in § 77.31 with regard to captive a herd is qualified on January 1 of a cervids that originate in a nonaccred- given year, the anniversary date will ited State or zone, a captive cervid be January 1 of each consecutive year). from a monitored herd may be moved Qualified herd status remains in effect interstate only if: for 12 months (365 days) following the (1) The captive cervid is not known anniversary date of the qualifying test. to be infected with or exposed to tuber- Qualified herd status will be suspended culosis; and between the anniversary date and the (2) The captive cervid is accompanied requalifying test, if the herd is not by a certificate, as provided in tested within 12 months. During the § 77.32(c), that includes a statement suspension period, the herd will be con- that the captive cervid is from a mon- sidered ‘‘unclassified’’ and captive itored herd. Except as provided in para- cervids may be moved interstate from graph (b)(3) of this section, the certifi- the herd only in accordance with the cate must also state that the captive movement requirements for the State cervid has tested negative to an official or zone in which the herd is located. tuberculosis test conducted within 90 days prior to the date of movement. If § 77.37 Interstate movement from mon- a group of captive cervids from a monitored herds. itored herd is being moved interstate (a) Qualifications. To be recognized as together to the same destination, all a monitored herd: captive cervids in the group may be (1) Identification records must be moved under one certificate. maintained by the person, firm, or cor- (3) Captive cervids under 1 year of poration responsible for the manage- age that are natural additions to the ment of the herd for as long as status monitored herd or that were born in as a monitored herd is desired. Such and originate from a classified herd records must be maintained on all cap- may move without testing, provided tive cervids in the herd that are that the certificate accompanying slaughtered, inspected, and found nega- them states that the captive cervids tive for tuberculosis at an approved are natural additions to the monitored slaughtering establishment or herd or were born in and originated necropsied at an approved diagnostic from a classified herd and have not laboratory. Identification records may been exposed to captive cervids from also include captive cervids from the an unclassified herd. herd that tested negative for tuber- (c) Herd additions allowed. No captive culosis in accordance with require- cervid may be added to a monitored ments for interstate movement. No less herd except in accordance with para- than one-half of the captive cervids on graph (c)(4) and either paragraph (c)(1), which records are kept must be slaugh- (c)(2), or (c)(3) of this section, as fol- ter inspected; and lows: (2) A sufficient number of captive (1) The captive cervid to be added cervids in the herd must be slaughter must be moved directly from an ac- inspected or tested for interstate move- credited herd; ment to ensure that tuberculosis infection at a prevalence level of 2 percent or more will be detected with a con- tested for interstate movement, depending on the size of a herd, to meet this require- 2 fidence level of 95 percent. A max- ment may be obtained from the National Animal Health Programs staff, Veterinary 2 A chart showing the number of captive Services, APHIS, 4700 River Road Unit 43, cervids that must be slaughter inspected or Riverdale, MD 20737–1231.

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(2) The captive cervid to be added and the number of captive cervids that must be moved directly from a quali- have tested negative for tuberculosis in fied or monitored herd and must have accordance with interstate movement tested negative to an official tuber- requirements. The number of slaughter culosis test conducted within 90 days inspections or negative testing captive prior to movement to the premises of cervids reported in any given year the monitored herd; or must be at least 25 percent of the total (3) If the captive cervid to be added is number required over a 3-year period to not being moved directly from a classi- qualify a herd for monitored herd sta- fied herd, the captive cervid must be tus. During each consecutive 3-year pe- isolated from all other animals and riod, 100 percent of the qualifying total must test negative to two official tu- must be reported. berculosis tests. The isolation must begin at the time of the first official [65 FR 63517, Oct. 23, 2000, as amended at 71 FR 24806, Apr. 27, 2006] tuberculosis test. The tests must be conducted at least 90 days apart, and § 77.38 Interstate movement from the second test must be conducted herds that are not accredited, quali- within 90 days prior to movement to fied, or monitored. the premises of the monitored herd. The Administrator may, with the The captive cervid must then be kept concurrence of the cooperating State in isolation from all animals until it animal health officials of the State of tests negative to an official tuber- destination, and upon request in spe- culosis test conducted at least 90 days cific cases, permit the movement of following the date it arrives at the captive cervids not otherwise provided premises of the monitored herd. If a for in this part which have not been group of captive cervids is being moved classified as reactors and are not other- together, the entire group must be iso- wise known to be affected with tuber- lated from all other animals during the culosis, under such conditions as the testing period, but captive cervids in Administrator may prescribe in each the group need not be isolated from specific case to prevent the spread of each other during that period. Such tuberculosis. The Administrator shall herd additions will not receive status promptly notify the appropriate co- as members of the monitored herd for operating State animal health officials purposes of interstate movement until of the State of destination of any such they have tested negative to an official action. tuberculosis test and been released from isolation. § 77.39 Other interstate movements. (4) A captive cervid to be added must not have been exposed during the 90 (a) Herds containing a suspect—(1) The days prior to its movement to either: suspect. (i) A captive cervid classified (i) A captive cervid from a herd with as a suspect on the SCT test must be a lower classification status than its quarantined until it is slaughtered or own; or retested by the CCT test and found (ii) Any tuberculous livestock. negative for tuberculosis. Retesting (d) Maintenance of monitored herd sta- must be as follows: tus. The person, firm, or corporation (A) The first CCT test must be ad- responsible for the management of the ministered within the first 10 days fol- herd must submit an annual report to lowing the SCT test or, if not, must be cooperating State or Federal animal administered at least 90 days after the health officials prior to the anniver- SCT test. If the CCT test is adminis- sary date of classification. This report tered within 10 days of the SCT test, must give the number of captive the injection must be on the side of the cervids currently in the herd; the num- neck opposite the injection for the SCT ber of captive cervids from the herd 1 test. year of age and older identified, (B) [Reserved] slaughtered, and inspected at an ap- (ii) A captive cervid classified as a proved slaughtering establishment or suspect on the first CCT test must be necropsied at an approved diagnostic quarantined until the following has oc- laboratory during the preceding year; curred:

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(A) A suspect on the first CCT test is be subject to the provisions for affected tested with a second CCT test at least herds in paragraph (d) of this section. 90 days after the first CCT test and is (iii) If upon slaughter inspection or found negative for tuberculosis. necropsy all reactors exhibit no gross (B) [Reseerved] lesions (NGL) of tuberculosis and no (2) The remainder of the herd. Any evidence of tuberculosis infection is herd containing a suspect to an official found by histopathology and culture of tuberculosis test must be quarantined M. bovis on specimens taken from the until the suspect is retested by the NGL animals, the remainder of the CCT test or the BTB test and found herd may be released from quarantine, negative for tuberculosis, or the sus- and captive cervids from the herd may pect is inspected at slaughter or be moved interstate in accordance with necropsied and found negative for tu- the herd classification status in effect berculosis after histopathology and before the herd was quarantined if one culture of selected tissues. If the sus- of the following conditions is met: pect is found negative for tuberculosis (A) The remainder of the herd is upon testing, or after slaughter inspec- given a whole herd test and is found tion or necropsy and histopathology negative for tuberculosis. and culture of selected tissues, the (B) The remainder of the herd is herd may be released from quarantine given a whole herd test, and all reac- and will return to the herd classifica- tors to the whole herd test exhibit no tion status in effect before the herd gross lesions (NGL) of tuberculosis was quarantined. If the suspect is clas- upon slaughter inspection or necropsy sified as a reactor upon testing, or and no evidence of tuberculosis infec- after slaughter inspection or necropsy tion is found by histopathology or cul- and histopathology and/or culture of ture of M. bovis on specimens taken selected tissues, the herd may be re- from the NGL animals. leased from quarantine only in accord- (iv) If no evidence of tuberculosis is ance with paragraph (b) of this section found in any reactor upon slaughter infor herds containing a reactor. spection or necropsy, but it is not pos- (b) Herds containing a reactor. The fol- sible to conduct a whole herd test on lowing requirements apply to herds the remainder of the herd, the herd will containing a reactor, except for herds be evaluated, based on criteria such as that have received captive cervids from the testing history of the herd and the an affected herd. Herds that have re- State history of tuberculosis infection, ceived captive cervids from an affected by the DTE to determine whether the herd must be quarantined and tested in herd may be released from quarantine. accordance with paragraph (e) of this (c) Herds found to have only lesions of section. tuberculosis. A herd in which captive (1) The reactor. Captive cervids classi- cervids with lesions compatible with or fied as reactors must be quarantined. suggestive of tuberculosis are found by (2) The remainder of the herd. Any histopathology without the isolation of herd containing reactors must be quar- M. bovis may be released from quarantined until the reactors are slaugh- antine and return to the herd classi- tered or necropsied in accordance with fication status in effect before the herd § 77.40 and: was quarantined, with the concurrence (i) If, upon slaughter inspection or of the DTE, if the herd tests negative necropsy, any reactors exhibit lesions to tuberculosis on a whole herd test compatible with or suggestive of tuber- conducted 90 days following the re- culosis, found by histopathology, with- moval of the lesioned captive cervid, out the isolation of M. bovis, the re- provided the herd has not been exposed mainder of the herd may be released to M. bovis during the 90 days. To main- from quarantine in accordance with tain its herd classification status, the the provisions of paragraph (c) of this herd must test negative to two annual section. whole herd tests beginning 10–12 (ii) If M. bovis is isolated from any re- months after the herd is released from actors, the remainder of the herd will quarantine. If any captive cervids in be considered an affected herd, and will the herd respond to one of the tests,

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the herd will be subject to the provi- (2) If any of the exposed captive sions of paragraph (a) or (b) of this sec- cervids are found to exhibit lesions tion. If the herd is not given the two compatible with or suggestive of tuber- annual whole herd tests, it will become culosis, found by histopathology, with- an unclassified herd. out the isolation of M. bovis, the receiv- (d) Affected herds. A herd determined ing herd will be subject to appropriate to be an affected herd must be quar- testing as determined by the DTE. antined until the herd has tested nega- (3) If all the exposed captive cervids tive to three whole herd tests in suc- test negative for tuberculosis, the re- cession, with the first test given 90 ceiving herd will be released from quar- days or more after the last test yield- antine if it is given a whole herd test ing a reactor and the last two tests and is found negative for tuberculosis given at intervals of not less than 180 and will return to the herd classifica- days. If the herd tests negative to the tion in effect before the herd was quar- three whole herd tests, it will be re- antined. In addition, the receiving herd leased from quarantine, but will be must be retested with the SCT test 1 considered an unclassified herd, and year after release from quarantine in captive cervids may only be moved order for captive cervids from the herd interstate from the herd in accordance to continue to be moved interstate. with the movement requirements for Supplemental diagnostic tests may be the State or zone in which the herd is used if any captive cervids in the herd located. In addition, the herd must be show a response to the SCT test. (f) Source herds. A herd suspected of given five consecutive annual whole being the source of tuberculous captive herd tests after release from quar- cervids based on a slaughter traceback antine. (These five tests will count to- investigation must be quarantined ward qualifying the herd for herd clas- upon notification (by the person con- sification.) As an alternative to test- ducting the investigation) to the USDA ing, the herd may be depopulated. area veterinarian in charge for the (e) Herds that have received captive State in which the herd resides, and a cervids from an affected herd. If a herd herd test must be scheduled. If the herd has received captive cervids from an af- is suspected of being the source of fected herd, the captive cervids from slaughter captive cervids having le- the affected herd of origin will be con- sions of tuberculosis, the herd test sidered exposed to tuberculosis. The ex- must be done by a veterinarian em- posed captive cervids and the receiving ployed by the State in which the test is herd must be quarantined. The exposed administered or employed by USDA. captive cervids must be slaughtered, (1) If the herd is identified as the necropsied, or tested with the SCT test source of captive cervids having lesions by a veterinarian employed by the of tuberculosis and M. bovis has been State in which the test is administered confirmed by bacterial isolation from or employed by USDA. Any exposed the slaughter animal, all captive captive cervid that responds to the cervids in the herd that respond to the SCT test must be classified as a reactor SCT test must be classified as reactors. and must be slaughter inspected or If none respond to the SCT test, the necropsied. Any exposed captive cervid herd may be released from quarantine that tests negative to the SCT test will and will return to the herd classifica- be considered as part of the affected tion status in effect before the herd herd of origin for purposes of testing, was quarantined, unless the DTE quarantine, and the five annual whole judges that additional testing is appro- herd tests required for affected herds in priate to ensure the herd’s freedom paragraph (d) of this section. from tuberculosis. (1) If bovine tuberculosis is confirmed (2) If the herd is identified as the in any of the exposed captive cervids source of captive cervids that exhibit by bacterial isolation of M. bovis, the lesions compatible with or suggestive receiving herd will be classified as an of tuberculosis, found by affected herd and will be subject to the histopathology, without the isolation provisions for affected herds in para- of M. bovis, all captive cervids in the graph (d) of this section. herd that respond to the SCT test must

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be classified as suspects, and supple- employed by the State in which the mental tests must be applied. captive cervid was classified, and who (3) If the herd is not identified as the is trained in tuberculosis necropsy pro- source herd, the herd will be released cedures. from quarantine if the herd is given a (2) If, upon necropsy, a captive cervid whole herd test and is found negative is found without evidence of M. bovis for tuberculosis. The herd will then re- infection by histopathology and cul- turn to the herd classification status in ture, the captive cervid will be consid- effect before the herd was quarantined. ered negative for tuberculosis. (g) Newly assembled herds. (1)A newly (3) Reactors, suspects, and exposed assembled herd will be classified as captive cervids may be slaughtered having the herd status of the herd from only at an approved slaughtering es- which the captive cervids originated. If tablishment, as defined in § 77.20. the herd is assembled from captive (b) Interstate movement to necropsy or cervids from more than one herd, it slaughter—(1) Permit. Any reactor, sus- will be classified as having the herd pect, or exposed captive cervid to be status of the originating herd with the moved interstate to necropsy or lowest status. A newly assembled herd slaughter must be accompanied by a will also assume the testing schedule of permit issued by a representative of the herd status it is given. Captive APHIS, a State representative, or an cervids in the herd must have no expo- accredited veterinarian. The captive sure to captive cervids from a herd of cervid must remain on the premises lesser status than the herd of origin de- where it was identified as a reactor, termining the status of the newly as- suspect, or exposed captive cervid until sembled herd or to any tuberculous a permit for its movement is obtained. livestock. No stopover or diversion from the des- (2) A herd newly assembled on prem- tination listed on the permit is al- ises where a tuberculous herd has been lowed. If a change in destination be- depopulated must be given two con- comes necessary, a new permit must be secutive annual whole herd tests. The obtained from a cooperating State or first test must be administered at least Federal animal health official or an ac- 6 months after the assembly of the new credited veterinarian before the inter- herd. If the whole herd tests are not state movement begins. The permit conducted within the indicated time- must list: frame, the herd will be quarantined. If (i) The classification of the captive the herd tests negative to the two cervid (reactor, suspect, or exposed); whole herd tests, there are no further (ii) The reactor eartag number or, for requirements. If any captive cervid in suspects and exposed captive cervids, the herd responds on one of the whole the official eartag or other approved herd tests, the herd will be subject to identification number; the provisions of paragraph (a) or (b) of (iii) The owner’s name and address; this section. If the premises has been (iv) The origin and destination of the vacant for more than 1 year preceding captive cervids; the assembly of the new herd on the (v) The number of captive cervids premises, these requirements may be covered by the permit; and waived if the risk of tuberculosis trans- (vi) The purpose of the movement. mission to the newly assembled herd is (2) Identification of reactors. Reactors deemed negligible by cooperating State must be tagged with an official eartag and Federal animal health officials. attached to the left ear and bearing a [65 FR 63517, Oct. 23, 2000, as amended at 71 serial number and the inscription ‘‘U.S. FR 24806, Apr. 27, 2006] Reactor,’’ and either: (i) Branded with the letter ‘‘T’’ high § 77.40 Procedures for and interstate on the left hip near the tailhead and at movement to necropsy and slaugh- least 5 by 5 centimeters (2 by 2 inches) ter. in size; or (a) Procedures for necropsy and slaugh- (ii) Permanently identified by the ter. (1) A necropsy must be performed letters ‘‘TB’’ tattooed legibly in the by or under the supervision of a veteri- left ear, sprayed on the left ear with narian who is employed by USDA or yellow paint, and either accompanied

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directly to necropsy or slaughter by an PART 78—BRUCELLOSIS APHIS or State representative or moved directly to necropsy or slaugh- Subpart A—General Provisions ter in a vehicle closed with official seals. Such official seals must be ap- Sec. 78.1 Definitions. plied and removed by an APHIS rep- 78.2 Handling of certificates, permits, and resentative, State representative, ac- ‘‘S’’ brand permits for interstate move- credited veterinarian, or an individual ment of animals. authorized for this purpose by an 78.3 Handling in transit of cattle and bison APHIS representative. moved interstate. 78.4 [Reserved] (3) Identification of exposed captive cervids. Exposed captive cervids must Subpart B—Restrictions on Interstate be identified by an official eartag or Movement of Cattle Because of Brucellosis other approved identification and either: 78.5 General restrictions. 78.6 Steers and spayed heifers. (i) Branded with the letter ‘‘S’’ high 78.7 Brucellosis reactor cattle. on the left hip near the tailhead and at 78.8 Brucellosis exposed cattle. least 5 by 5 centimeters (2 by 2 inches) 78.9 Cattle from herds not known to be af- in size; or fected. (ii) Either accompanied directly to 78.10 Official vaccination of cattle moving into and out of Class B and Class C necropsy or slaughter by an APHIS or States or areas. State representative or moved directly 78.11 Cattle moved to a specifically ap- to necropsy or slaughter in a vehicle proved stockyard not in accordance with closed with official seals. Such official this part. seals must be applied and removed by 78.12 Cattle from quarantined areas. 78.13 Other movements. an APHIS representative, State rep- 78.14 Rodeo bulls. resentative, accredited veterinarian, or 78.15–78.19 [Reserved] an individual authorized for this purpose by an APHIS representative. Subpart C—Restrictions on Interstate Movement of Bison Because of Brucellosis § 77.41 Cleaning and disinfection of premises, conveyances, and mate- 78.20 General restrictions. 78.21 Bison steers and spayed heifers. rials. 78.22 Brucellosis reactor bison. All conveyances and associated 78.23 Brucellosis exposed bison. equipment, premises, and structures 78.24 Bison from herds not known to be af- that are used for receiving, holding, fected. 78.25 Other movements. shipping, loading, unloading, and deliv- 78.26–78.29 [Reserved] ering captive cervids in connection with their interstate movement and Subpart D—Restrictions on Interstate that are determined by cooperating Movement of Swine Because of Brucellosis State and Federal animal health offi- 78.30 General restrictions. cials to be contaminated because of oc- 78.31 Brucellosis reactor swine. cupation or use by tuberculous or reac- 78.32 Brucellosis exposed swine. tor livestock must be cleaned and dis- 78.33 Sows and boars. infected under the supervision of the 78.34 Other movements. cooperating State or Federal animal 78.35–78.39 [Reserved] health officials. Such cleaning and dis- Subpart E—Designation of Brucellosis infecting must be done in accordance Areas with the procedures approved by the cooperating State or Federal animal 78.40 Designation of States/areas. health officials. Cleaning and disinfec- 78.41 State/area classification. 78.42 Quarantined areas. tion must be completed before the 78.43 Validated brucellosis-free States. premises, conveyances, or materials AUTHORITY: 7 U.S.C. 8301–8317; 7 CFR 2.22, may again be used to convey, hold, or 2.80, and 371.4. in any way come in contact with any livestock. SOURCE: 51 FR 32580, Sept. 12, 1986, unless otherwise noted.

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Subpart A—General Provisions Person Postparturient § 78.1 Definitions. Purebred registry association Qualified herd The following terms are defined in Quarantined area this section: Quarantined feedlot Quarantined pasture Accredited veterinarian Recognized slaughtering establishment Administrator ‘‘S’’ branded Animals ‘‘S’’ brand permit Animal and Plant Health Inspection Service Sow Animal identification number Specifically approved stockyard APHIS representative State Approved brucella vaccine State animal health official Approved individual herd plan State representative Approved intermediate handling facility Successfully closed case Area Swine brucellosis ‘‘B’’ branded Test-eligible cattle and bison Boar United States Brucellosis United States Department of Agriculture Brucellosis exposed backtag Brucellosis negative Validated brucellosis-free herd Brucellosis reactor Validated brucellosis-free State Brucellosis ring test Veterinarian in Charge Brucellosis suspect Whole herd vaccination Certificate Certified brucellosis-free herd As used in this part, the following Class A State or area terms shall have the meanings set Class B State or area forth in this section. Class C State or area Accredited veterinarian. A veteri- Class Free State or area narian approved by the Administrator Complete herd test (CHT) in accordance with the provisions of Confirmatory test Dairy cattle part 161 of this title to perform func- Designated epidemiologist tions specified in parts 1, 2, 3, and 11 of Directly subchapter A, and subchapters B, C, Epidemiologist and D of this chapter, and to perform Epidemiology functions required by cooperative Farm of origin State-Federal disease control and Feral swine eradication programs. Finished fed cattle Administrator. The Administrator, Herd Animal and Plant Health Inspection Herd blood test Herd known to be affected Service, or any person authorized to Herd not known to be affected act for the Administrator. Herd of origin of swine Animals. Cattle, bison, and swine. Interstate Animal and Plant Health Inspection Market cattle identification test cattle Service (APHIS). The Animal and Plant Market swine test (MST) reactor Health Inspection Service of the United Market swine test swine States Department of Agriculture. Monitored-negative feral swine population Animal identification number (AIN). A Moved numbering system for the official iden- Moved (movement) in interstate commerce tification of individual animals in the Official adult vaccinate Official brand inspection certificate United States providing a nationally Official brand recording agency unique identification number for each Official calfhood vaccinate animal. The AIN contains 15 digits, Official eartag with the first 3 being the country code Official seal (840 for the United States), the alpha Official swine tattoo characters USA, or the numeric code Official test assigned to the manufacturer of the Official vaccinate identification device by the Inter- Official vaccination eartag Originate national Committee on Animal Record- Parturient ing. The AIN beginning with the 840 Permit prefix may be used only on animals Permit for entry born in the United States.

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APHIS representative. An individual ing to cattle or bison which are or have employed by APHIS who is authorized been in the facility shall be maintained to perform the function involved. by the facility for a period of 2 years; Approved brucella vaccine. A Brucella (e) State representatives and APHIS product approved by and produced representatives shall be granted, at under license of the United States De- reasonable hours, access to all docu- partment of Agriculture for injection ments required to be maintained by the into cattle or bison to enhance their facility and authority to reproduce the resistance to brucellosis. documents; and (f) Each entrance and Approved individual herd plan. A herd exit to the facility must prominently management and testing plan designed display a sign bearing the following by the herd owner, the owner’s veteri- words: ‘‘All cattle and bison entering narian if so requested, and a State rep- this facility must go directly to resentative or APHIS representative to slaughter or a quarantined feedlot’’. determine the disease status of animals The Administrator may withdraw or in the herd and to control and eradi- deny approval of any intermediate han- cate brucellosis within the herd. The dling facility in accordance with § 71.20 plan must be jointly approved by the of this chapter. State animal health official and the Area. That portion of any State Veterinarian in Charge. which has a separate brucellosis classi- Approved intermediate handling facil- fication under this part. ity. Premises approved by the Adminis- ‘‘B’’ branded. Branding with a hot trator and the State animal health of- iron the letter ‘‘B’’ high on the left hip ficial for receiving and handling cattle near the tailhead and at least 5 by 5 and bison for release only to recognized centimeters (2 by 2 inches) in size. slaughtering establishments and quar- Boar. An uncastrated male swine 6 antined feedlots. Cattle and bison may months of age or over which is or has be held at an approved intermediate been capable of being used for breeding handling facility for a maximum of 7 purposes. days and may not change ownership Brucellosis. The contagious, infec- during this time. No cattle or bison, tious, and communicable disease except cattle or bison moved directly caused by bacteria of the genus from a farm of origin, shall be per- Brucella. It is also known as Bangs dis- mitted to enter an approved inter- ease, undulant fever, and contagious mediate handling facility unless they abortion. are accompanied by a permit or ‘‘S’’ Brucellosis exposed. Except for brucel- brand permit. Cattle or bison trans- losis reactors, animals that are part of ported in vehicles closed with official a herd known to be affected, or are in seals are prohibited from entering the a quarantined feedlot or a quarantined approved intermediate handling facil- pasture, or are brucellosis suspects, or ity. No cattle or bison shall be per- that have been in contact with a bru- mitted to leave an approved inter- cellosis reactor for a period of 24 hours mediate handling facility unless they or more, or for a period of less than 24 are accompanied by a permit or ‘‘S’’ hours if the brucellosis reactor has brand permit which lists a recognized aborted, calved, or farrowed within the slaughtering establishment or a quar- past 30 days or has a vaginal or uterine antined feedlot as the point of destina- discharge. tion. To qualify for and retain ap- Brucellosis negative. An animal sub- proval, the following conditions must jected to one or more official tests re- be met: (a) The facility must be sepa- sulting in a brucellosis negative classi- rate and apart from other livestock fication or reclassified as brucellosis handling facilities for breeding cattle negative by a designated epidemiolo- and breeding bison; (b) Serviceable gist as provided for in the definition of equipment for cleaning and disinfec- official test. tion shall be furnished and maintained Brucellosis reactor. An animal sub- with adequate disinfectant on hand; (c) jected to an official test resulting in a The facility must be cleaned and dis- brucellosis reactor classification or infected in accordance with § 71.4(a) of subjected to a bacteriological examina- this chapter; (d) Any document relat- tion for field strain Brucella abortus and

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found positive or reclassified as a bru- (1) The document must be a state cellosis reactor by a designated epi- form or APHIS form that requires indi- demiologist as provided for in the defi- vidual identification of animals; nition of official test. (2) A legible copy of the document Brucellosis ring test. The brucellosis must be stapled to the original and ring test is conducted on composite each copy of the certificate; milk or cream samples from dairy (3) Each copy of the document must herds and is interpreted as either nega- identify each animal to be moved with tive or suspicious (positive). Herds the certificate, but any information which are negative to the brucellosis pertaining to other animals, and any ring test and which are not quar- unused space on the document for re- antined as brucellosis affected are clas- cording animal identification, must be sified as brucellosis negative for public crossed out in ink; and health ordinances and surveillance pur- (4) The following information must poses. Herds classified as suspicious re- be written in ink in the identification quire a herd blood test to determine column on the original and each copy animal and herd status. of the certificate and must be circled Brucellosis suspect. An animal sub- or boxed, also in ink, so that no addi- jected to an official test resulting in a tional information can be added: brucellosis suspect classification or re- (i) The name of the document; and classified as a brucellosis suspect by a (ii) Either the serial number on the designated epidemiologist as provided document or, if the document is not for in the definition of official test. imprinted with a serial number, both Certificate. An official document the name of the person who prepared issued by an APHIS representative, the document and the date the docu- state representative, or accredited vet- ment was signed. erinarian at the point of origin of an (c) As an alternative to typing or interstate movement of animals. writing ownership brands on a certifi- (a) The certificate must show the of- cate, an official brand inspection cer- ficial eartag number, individual animal tificate may be used to provide this in- register breed association registration formation, but only under the fol- tattoo, individual animal registered lowing conditions: breed association registration brand, (1) A legible copy of the official brand individual animal registered breed as- inspection certificate must be stapled sociation registration number, or simi- to the original and each copy of the lar individual identification of each certificate; animal to be moved; the number of ani- (2) Each copy of the official brand in- mals covered by the certificate; the spection certificate must show the purpose for which the animals are to be ownership brand of each animal to be moved; the points of origin and des- moved with the certificate, but any tination; the consignor; and the con- other ownership brands, and any un- signee. Ownership brands may be used used space for recording ownership in place of individual animal identi- brands, must be crossed out in ink; fication on certificates for cattle (3) The following information must moved interstate when no official test be written in ink in the identification for brucellosis is required under this column on the original and each copy part, provided the ownership brands of the certificate and must be circled are registered with the official brand or boxed, also in ink, so that no addi- recording agency. Except as provided tional information can be added: in paragraphs (b) and (c) of this defini- (i) The name of the attached docu- tion, all of the information required by ment; and this paragraph must be typed or writ- (ii) Either the serial number on the ten on the certificate. official brand inspection certificate or, (b) As an alternative to typing or if the official brand inspection certifi- writing individual animal identifica- cate is not imprinted with a serial tion on a certificate, another document number, both the name of the person may be used to provide this informa- who prepared the official brand inspection, but only under the following con- tion certificate and the date it was ditions: signed.

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Certified brucellosis-free herd. A herd (c) Loss of certification. A herd which of cattle or bison which has qualified loses certified brucellosis-free herd sta- for and whose owner has been issued a tus because a brucellosis reactor is certified brucellosis-free herd certifi- found in the herd may be recertified cate signed by the appropriate State only by repeating the certification animal health official and the Veteri- process, except that certified brucel- narian in Charge. losis-free herd status may be reinstated (a) Certification. The following meth- without repeating the certification ods may be used to qualify a herd: process if epidemiological studies and (1) By conducting at least two con- bacteriological cultures conducted by secutive negative herd blood tests not an APHIS representative or State rep- less than 10 months nor more than 14 resentative show that the herd was not months apart; or affected with Brucella abortus. (2) As an alternative for dairy cattle, Class A State or area. A State or area by conducting a minimum of four con- which meets standards for classifica- secutive negative brucellosis ring tests, tion as a Class A State or area and is or other official brucellosis milk test certified as such on initial classifica- approved by the Administrator, at not tion or on reclassification by the State less than 90-day intervals, followed by animal health official, the Veteri- a negative herd blood test within 90 narian in Charge, and the Adminis- days after the last negative brucellosis trator. Any reclassification will be ring test or other official brucellosis made in accordance with § 78.40 of this milk test approved by the Adminis- part. The following are the standards trator. to attain and maintain Class A status. (b) Maintaining certification. Certified (a) Surveillance—(1) Brucellosis ring brucellosis-free herd status will remain test. The brucellosis ring test shall be in effect for 1 year beginning with the conducted in the State or area at least date of issuance of the certified brucel- four times per year at approximately losis-free herd certificate. The fol- 90-day intervals. All herds producing lowing methods may be used to main- milk for sale shall be included in at tain herd certification: least three of the four brucellosis ring (1) A negative herd blood test must tests per year. be conducted within 10 to 12 months of (2) Market Cattle Identification (MCI) the last certification date for contin- program—(i) Coverage. All recognized uous status. Lapsed certification may slaughtering establishments in the be reinstated if a herd blood test is State or area must participate in the conducted within 14 months of the last MCI program. Blood samples shall be certification date. A new recertifi- collected from at least 95 percent of all cation test date may be established if cows and bulls 2 years of age or over at requested by the owner and if the herd each recognized slaughtering establish- is negative to a herd blood test on that ment and subjected to an official test; date, provided that date is within 1 (ii) Brucellosis reactors—(A) year of the previous certification date. Tracebacks. At least 90 percent of all (2) As an alternative for dairy cattle, brucellosis reactors found in the course a minimum of four consecutive nega- of MCI testing must be traced to the tive brucellosis ring tests, or other offi- farm of origin. cial brucellosis milk test approved by (B) Successfully closed cases. The State the Administrator, must be conducted or area must successfully close at least at approximately 90-day intervals, with 95 percent of the MCI reactor cases the fourth test conducted within 60 traced to the farm of origin during the days before the 1-year anniversary of 12-consecutive-month period imme- the previous certification date. diately prior to the most recent anni- (3) The Administrator may allow an- versary of the date the State or area other testing protocol to be used if the was classified Class A. To successfully Administrator determines that such a close an MCI reactor case, State rep- protocol is adequate to determine there resentatives or APHIS representatives is no evidence of brucellosis in the must conduct an epidemiologic inves- herd. tigation at the farm of origin within 15

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days after notification by the coopera- (b) Herd infection rate—(1) Percentage tive State-Federal laboratory that bru- of herds affected. States or areas must cellosis reactors were found on the MCI not exceed a cattle herd infection rate, test. Herd blood tests must be con- based on the number of herds found to ducted or the herd must be confined to have brucellosis reactors within the the premises under quarantine within State or area during any 12 consecutive 30 days after notification that brucel- months due to field strain Brucella losis reactors were found on the MCI abortus, of 0.25 percent or 2.5 herds per test, unless a designated epidemiolo- 1,000, except in States with 10,000 or gist determines that: fewer herds. A special review by the (1) The brucellosis reactor is located Administrator will be made to deter- in a herd in a different State than the mine if such small herd population State where the MCI blood sample was States would qualify for Class A status. collected. In such cases a State rep- Locations of herds, sources of brucel- resentative or APHIS representative losis, and brucellosis control measures must give written notice of the MCI taken by the State will be considered. test results to the State animal health (2) Epidemiologic investigation. Within official in the State where the brucel- 15 days after notification by the coop- losis reactor is located; or erative State-Federal laboratory that (2) Evidence indicates that the bru- brucellosis reactors have been found in cellosis reactor is from a herd that no any herd, State representatives or longer presents a risk of spreading bru- APHIS representatives shall inves- cellosis, or is from a herd that is un- tigate that herd to identify possible likely to be infected with brucellosis. sources of brucellosis. All possible Such evidence could include, but is not sources of brucellosis identified shall limited to, situations where: be contacted within an additional 15 (i) The brucellosis reactor is traced days to determine appropriate action. back to a herd that has been sold for (3) All herds known to be affected slaughter in entirety; shall have approved individual herd (ii) The brucellosis reactor is traced plans in effect within 15 days after no- back to a herd that is certified brucel- tification by a State representative or losis free and is 100-percent vaccinated; APHIS representative of a brucellosis or reactor in the herd. Each State shall (iii) The brucellosis reactor showed a ensure that such approved individual low titer in the MCI test and is traced herd plans are effectively complied back to a dairy herd that is 100 percent with, as determined by the Adminis- vaccinated and has tested negative to trator. the most recent brucellosis ring test Class B State or area. A State or area required by this section for herds pro- which meets standards for classifica- ducing milk for sale. tion as a Class B State or area and is (3) Epidemiologic surveillance—(i) Adja- certified as such on initial classifica- cent herds. All adjacent herds or other tion or on reclassification by the State herds having contact with cattle in a animal health official, the Veteri- herd known to be affected shall have an narian in Charge, and the Adminis- approved individual herd plan in effect trator. Any reclassification will be within 15 days of notification of brucel- made in accordance with § 78.40 of this losis in the herd known to be affected; part. The following are the standards (ii) Epidemiologically traced herds. All to attain and maintain Class B status. herds from which cattle are moved into (a) Surveillance—(1) Brucellosis ring a herd known to be affected and all test. The brucellosis ring test shall be herds which have received cattle from conducted in the State or area at least a herd known to be affected shall have four times per year at approximately an approved individual herd plan in ef- 90-day intervals. All herds producing fect within 15 days of locating the milk for sale shall be included in at source herd or recipient herd. (iii) Each least three of the four brucellosis ring State shall ensure that such approved tests per year. individual herd plans are effectively (2) Market Cattle Identification (MCI) complied with, as determined by the program—(i) Coverage. All recognized Administrator. slaughtering establishments in the

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State or area must participate in the vaccinated and has tested negative to MCI program. Blood samples shall be the most recent brucellosis ring test collected from at least 95 percent of all required by this section for herds pro- cows and bulls 2 years of age or over at ducing milk for sale. each recognized slaughtering establish- (3) Epidemiologic surveillance—(i) Adja- ment and subjected to an official test; cent herds. All adjacent herds or other (ii) Brucellosis reactors—(A) herds having contact with cattle in a Tracebacks. At least 80 percent of all herd known to be affected shall have an brucellosis reactors found in the course approved individual herd plan in effect of MCI testing must be traced to the within 45 days of notification of brucel- farm of origin. losis in the herd known to be affected; (B) Successfully closed cases. The State (ii) Epidemiologically traced herds. All or area must successfully close at least herds from which cattle are moved into 90 percent of the MCI reactor cases a herd known to be affected and all traced to the farm of origin during the herds which have received cattle from 12-consecutive-month period imme- a herd known to be affected shall have diately prior to the most recent anni- an approved individual herd plan in ef- versary of the date the State or area fect within 45 days of locating the was classified Class B. To successfully source herd or recipient herd. (iii) Each close an MCI reactor case, State rep- State shall ensure that such approved resentatives or APHIS representatives individual herd plans are effectively must conduct an epidemiologic inves- complied with, as determined by the tigation at the farm of origin within 30 Administrator. days after notification by the coopera- (b) Herd infection rate—(1) Percentage tive State-Federal laboratory that bru- of herds affected. States or areas must cellosis reactors were found on the MCI not exceed a cattle herd infection rate, test. Herd blood tests must be con- based on the number of herds found to ducted or the herd must be confined to have brucellosis reactors within the the premises under quarantine within State or area during any 12 consecutive 30 days after notification that brucel- months due to field strain Brucella losis reactors were found on the MCI abortus, of 1.5 percent or 15 herds per test, unless a designated epidemiologist determines that: 1,000, except in States with 1,000 or (1) The brucellosis reactor is located fewer herds. A special review by the in a herd in a different State than the Administrator will be made to deter- State where the MCI blood sample was mine if such small herd population collected. In such cases a State rep- States would qualify for Class B status. resentative or APHIS representative Locations of herds, sources of brucel- must give written notice of the MCI losis, and brucellosis control measures test results to the State animal health taken by the State will be considered. official in the State where the brucel- (2) Epidemiologic investigation. Within losis reactor is located; or 45 days after notification by the coop- (2) Evidence indicates that the bru- erative State-Federal laboratory that cellosis reactor is from a herd that no brucellosis reactors have been found in longer presents a risk of spreading bru- any herd, State representatives or cellosis, or is from a herd that is un- APHIS representatives shall inves- likely to be infected with brucellosis. tigate that herd to identify possible Such evidence could include, but is not sources of brucellosis. All possible limited to, situations where: sources of brucellosis identified shall (i) The brucellosis reactor is traced be contacted within an additional 30 back to a herd that has been sold for days to determine appropriate action. slaughter in entirety; (3) All herds known to be affected (ii) The brucellosis reactor is traced shall have approved individual herd back to a herd that is certified brucel- plans in effect within 45 days after no- losis free and is 100-percent vaccinated; tification by a State representative or or APHIS representative of a brucellosis (iii) The brucellosis reactor showed a reactor in the herd. Each State shall low titer in the MCI test and is traced ensure that such approved individual back to a dairy herd that is 100 percent herd plans are effectively complied

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with, as determined by the Adminis- State where the MCI blood sample was trator. collected. In such cases a State rep- Class C State or area. A State or area resentative or APHIS representative which meets standards for classifica- must give written notice of the MCI tion as a Class C State or area and is test results to the State animal health certified as such on initial classifica- official in the State where the brucel- tion or on reclassification by the State losis reactor is located; or animal health official, the Veteri- (2) Evidence indicates that the bru- narian in Charge, and the Adminis- cellosis reactor is from a herd that no trator. Any reclassification will be longer presents a risk of spreading bru- made in accordance with § 78.40 of this cellosis, or is from a herd that is un- part. The following are the standards likely to be infected with brucellosis. to attain and maintain Class C status. Such evidence could include, but is not (a) Surveillance—(1) Brucellosis ring limited to, situations where: test. The brucellosis ring test shall be (i) The brucellosis reactor is traced conducted in the State or area at least back to a herd that has been sold for four times per year at approximately slaughter in entirety; 90-day intervals. All herds producing (ii) The brucellosis reactor is traced milk for sale shall be included in at back to a herd that is certified brucel- least three of the four brucellosis ring losis free and is 100-percent vaccinated; tests per year. or (2) Market Cattle Identification (MCI) (iii) The brucellosis reactor showed a program—(i) Coverage. All recognized slaughtering establishments in the low titer in the MCI test and is traced State or area must participate in the back to a dairy herd that is 100 percent MCI program. Blood samples shall be vaccinated and has tested negative to collected from at least 95 percent of all the most recent brucellosis ring test cows and bulls 2 years of age or over at required by this section for herds pro- each recognized slaughtering establish- ducing milk for sale. ment and subjected to an official test; (3) Epidemiologic surveillance—(i) Adja- (ii) Brucellosis reactors—(A) cent herds. All adjacent herds or other Tracebacks. At least 80 percent of all herds having contact with cattle in a brucellosis reactors found in the course herd known to be affected shall have an of MCI testing must be traced to the approved individual herd plan in effect farm of origin. within 45 days of notification of brucel- (B) Successfully closed cases. The State losis in the herd known to be affected; or area must successfully close at least (ii) Epidemiologically traced herds. All 90 percent of the MCI reactor cases herds from which cattle are moved into traced to the farm of origin during the a herd known to be affected and all 12-consecutive-month period imme- herds which have received cattle from diately prior to the most recent anni- a herd known to be affected shall have versary of the date the State or area an approved individual herd plan in ef- was classified Class C. To successfully fect within 45 days of locating the close an MCI reactor case, State rep- source herd or recipient herd. (iii) Each resentatives or APHIS representatives State shall ensure that such approved must conduct an epidemiologic inves- individual herd plans are effectively tigation at the farm of origin within 30 complied with, as determined by the days after notification by the coopera- Administrator. tive State-Federal laboratory that bru- (b) Herd infection rate—(1) Percentage cellosis reactors were found on the MCI of herds affected. States or areas exceed test. Herd blood tests must be con- a cattle herd infection rate, based on ducted or the herd must be confined to the number of herds found to have bru- the premises under quarantine within cellosis reactors within the State or 30 days after notification that brucel- area during any 12 consecutive months losis reactors were found on the MCI due to field strain Brucella abortus, of test, unless a designated epidemiolo- 1.5 percent or 15 herds per 1,000, except gist determines that: in States with 1,000 or fewer herds. A (1) The brucellosis reactor is located special review by the Administrator in a herd in a different State than the will be made to determine if such small

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herd population States should be clas- State or area in which brucellosis has sified as a Class C State. Locations of been known to exist must be released herds, sources of brucellosis, and bru- from any State or Federal brucellosis cellosis control measures taken by the quarantine prior to classification. In State will be considered. addition, if any herds of other species (2) Epidemiologic investigation. Within of domestic livestock have been found 45 days after notification by the coop- to be affected with brucellosis, they erative State-Federal laboratory that must be subjected to an official test brucellosis reactors have been found in and found negative, slaughtered, or any herd, State representatives or quarantined so that no foci of brucel- APHIS representatives shall inves- losis in any species of domestic live- tigate that herd to identify possible stock are left uncontrolled. The fol- sources of brucellosis. All possible lowing are the standards to maintain sources of brucellosis identified shall Class Free status. be contacted within an additional 30 (a) Surveillance—(1) Testing require- days to determine appropriate action. ments—(i) States or areas that have been (3) All herds known to be affected Class Free for 5 consecutive years or shall have approved individual herd longer and that do not have B. abortus in plans in effect within 45 days after no- wildlife. All recognized slaughtering es- tification by a State representative or tablishments in the State or area, upon APHIS representative of a brucellosis request by APHIS, must agree to par- reactor in the herd. Each State shall ticipate in market cattle identification ensure that such approved individual (MCI) testing as part of the national herd plans are effectively complied brucellosis surveillance plan. with, as determined by the Adminis- (ii) States or areas that have not been trator. Class Free for 5 consecutive years or (c) Compliance with minimum proce- longer or that have B. abortus in wildlife. dural standards. (1) A State must imple- The State or area must carry out test- ment and maintain minimum proce- ing as provided in paragraphs dural standards. (a)(1)(ii)(A) and (a)(1)(ii)(B) of this defi- (2) A State or area must make con- nition: tinued progress over a 2-year period in (A) Brucellosis ring test. The State or reducing the prevalence of brucellosis area shall conduct as many brucellosis as determined by epidemiologic evalua- ring tests per year as are necessary to tion or it will be placed under Federal ensure that all herds producing milk quarantine. for sale are tested at least twice per Class Free State or area. A State or year at approximately 6-month inter- area which meets standards for classi- vals. Another official brucellosis milk fication as a Class Free State or area test may be used as approved by the and is certified as such on initial clas- Administrator. sification or on reclassification by the (B) Market Cattle Identification (MCI) State animal health official, the Vet- program. All recognized slaughtering erinarian in Charge, and the Adminis- establishments in the State or area trator. For initial classification or re- must participate in the MCI program. classification, all cattle herds in the Blood samples shall be collected from State or area must have remained free at least 95 percent of all cows and bulls of Brucella abortus for 12 consecutive 2 years of age or over at each recog- months, based on surveillance and epi- nized slaughtering establishment and demiologic investigations as required subjected to an official test. for Class A States or areas, and the (2) Brucellosis reactors. All Class Free State or area must have a cattle herd States or areas must comply with the infection rate, based on the number of following requirements upon detection herds found to have brucellosis reac- of a brucellosis reactor: tors within the State or area during (i) Tracebacks. The State or area any 12 consecutive months due to must trace at least 90 percent of all Brucella abortus, of 0.0 percent or 0 brucellosis reactors found in the course herds per 1,000. Any reclassification of MCI testing to the farm of origin. will be made in accordance with § 78.40 (ii) Successfully closed cases. The State of this part. All cattle herds in the or area must successfully close at least

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95 percent of the MCI reactor cases (B) Epidemiologically traced herds. All traced to the farm of origin during the herds from which cattle are moved into 12-consecutive-month period imme- a herd known to be affected and all diately prior to the most recent anni- herds which have received cattle from versary of the date the State or area a herd known to be affected shall be was classified Class Free. To success- placed under quarantine and have an fully close an MCI reactor case, State approved individual herd plan in effect representatives or APHIS representa- within 15 days of locating the source tives must conduct an epidemiologic herd or recipient herd. Each State shall investigation at the farm of origin ensure that such approved individual within 15 days after notification by the herd plans are effectively complied cooperative State-Federal laboratory with, as determined by the Adminis- that brucellosis reactors were found on trator. the MCI test. Herd blood tests must be (b) Herd infection rate—(1) Affected conducted or the herd must be confined herds. Except as provided in paragraph to the premises under quarantine with- (b)(4) of this definition, all cattle herds in 30 days after notification that bru- in the State or area must remain free cellosis reactors were found on the MCI of Brucella abortus. test, unless a designated epidemiolo- (2) Epidemiologic investigation. Within gist determines that: 15 days after notification by the coop- (A) The brucellosis reactor is located erative State-Federal laboratory that in a herd in a different State than the brucellosis reactors have been found in State where the MCI blood sample was any herd, State representatives or collected. In such cases a State rep- APHIS representatives shall inves- resentative or APHIS representative tigate that herd to identify possible must give written notice of the MCI sources of brucellosis. All possible test results to the State animal health sources of brucellosis identified shall official in the State where the brucel- be contacted within an additional 15 losis reactor is located; or days to determine appropriate action. (B) Evidence indicates that the brucellosis reactor is from a herd that no (3) Approved herd plans. All herds longer presents a risk of spreading bru- known to be affected shall have ap- cellosis, or is from a herd that is un- proved individual herd plans in effect likely to be infected with brucellosis. within 15 days after notification by a Such evidence could include, but is not State representative or APHIS rep- limited to, situations where: resentative of a brucellosis reactor in (1) The brucellosis reactor is traced the herd. Each State shall ensure that back to a herd that has been sold for such approved individual herd plans are slaughter in entirety; effectively complied with, as deter- (2) The brucellosis reactor is traced mined by the Administrator. back to a herd that is certified brucel- (4) Affected herd. If any herd in a losis free and is 100-percent vaccinated; Class Free State or area is found to be or affected with brucellosis, the State or (3) The brucellosis reactor showed a area may retain its Class Free status if low titer in the MCI test and is traced it meets the conditions of this para- back to a dairy herd that is 100 percent graph; provided that the Administrator vaccinated and has tested negative to may reclassify a State or area to a the most recent brucellosis ring test lower status upon finding that contin- required by this section for herds pro- ued detection of brucellosis presents a ducing milk for sale. risk that the disease will spread. (iii) Epidemiologic surveillance—(A) (i) The affected herd. (A) The affected Adjacent herds. All adjacent herds or herd must be quarantined immediately, other herds having contact with cattle and, within 60 days, tested for brucel- in a herd known to be affected shall be losis and depopulated; or placed under quarantine and have an (B) The affected herd must be quar- approved individual herd plan in effect antined immediately and tested for within 15 days after notification of bru- brucellosis as required by the Adminis- cellosis in the herd known to be af- trator until there is no evidence of bru- fected; cellosis in the herd; and

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(ii) Other herds. An epidemiological (i) Define and explain the basis for investigation must be performed with- the geographic area in which a disease in 60 days of the detection of an in- risk exists from B. abortus and to which fected animal in a herd. All herds on the brucellosis management plan ac- premises adjacent to the affected herd tivities apply; (adjacent herds), all herds from which (ii) Describe epidemiologic assess- animals may have been brought into ment and surveillance activities to the affected herd (source herds), and all identify occurrence of B. abortus in do- herds that may have had contact with mestic livestock and wildlife and po- or accepted animals from the affected tential risks for spread of disease; and herd (contact herds) must be (iii) Describe mitigation activities to epidemiologically investigated, and prevent the spread of B. abortus from each of those herds must be placed domestic livestock and/or wildlife, as under an approved individual herd applicable, within or from the brucel- plan. If the investigating epidemiolo- losis management area. gist determines that a herd blood test Complete herd test (CHT). An official for a particular adjacent herd, source swine brucellosis test of all swine on a herd, or contact herd is not warranted, premises that are 6 months of age or the epidemiologist must include that older and maintained for breeding pur- determination, and the reasons sup- poses. porting it, in the individual herd plan. Confirmatory test. A follow-up test to (iii) APHIS review. After the close of verify any official test results. Con- the 60-day period following the date an firmatory tests include the standard animal in the herd is determined to be tube test, the Rivanol test, the com- infected, APHIS will conduct a review plement fixation test (CF), the fluores- to confirm that the requirements of cence polarization assay (FP assay), paragraphs (b)(4)(i) and (b)(4)(ii) of this the particle concentration fluorescence definition have been satisfied and that immunoassay (PCFIA), the semen plas- the State or area is in compliance with ma test, and the standard plate test. all other applicable provisions. A bovine animal of a rec- (c) Brucellosis management plans. (1) Dairy cattle. Any State in which the Administrator ognized dairy breed. has determined wildlife are infected Designated epidemiologist. An epi- with B. abortus must develop and im- demiologist selected by the State ani- plement a brucellosis management mal health official and the Veteri- plan approved by the Administrator. narian in Charge to perform the func- The existence of B. abortus in wildlife tions required. The regional epi- will be determined by the Adminis- demiologist and the APHIS brucellosis trator, based on, but not limited to, staff must concur in the selection and histopathology, testing data, or epide- appointment of the designated epi- miology. The Administrator may also demiologist. require a Class Free State or area to Directly. Without unloading en route develop and implement a brucellosis if moved in a means of conveyance, or management plan under any other cir- without stopping if moved in any other cumstances if the Administrator deter- manner. mines it is necessary to prevent the Epidemiologist. A veterinarian who spread of brucellosis. The State must has received a master’s degree in epide- sign a memorandum of understanding miology or completed a course of study (MOU) with the Administrator that de- in epidemiology sponsored by the Ani- scribes its brucellosis management mal and Plant Health Inspection Serv- plan. The MOU must be updated annu- ice, United States Department of Agri- ally. The Administrator may reclassify culture. to a lower status any State or area Epidemiology. A branch of medical that has not implemented an approved science that deals with the incidence, brucellosis management plan within 6 distribution, and control of disease in months of being required to develop the animal population. one. Farm of origin. (a) Premises where (2) The brucellosis management plan cattle or bison are born and remain reflected in the MOU must: prior to movement from the premises

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but which are not used to assemble cat- Interstate. From any State into or tle or bison from any other premises through any other State. for 4 months before such movement; or Market cattle identification test cattle. (b) Premises where cattle or bison re- Cows and bulls 2 years of age or over main for not less than 4 months imme- which have been moved to recognized diately before movement from the slaughtering establishments, and test- premises but which are not used to as- eligible cattle which are subjected to semble cattle or bison from any other an official test for the purposes of premises for 4 months before such movement at farms, ranches, auction movement. markets, stockyards, quarantined Feral swine. Free-roaming swine. For- feedlots, or other assembly points. merly free-roaming swine could qualify Such cattle shall be identified by an of- for reclassification as domestic swine ficial eartag and/or United States De- upon testing negative to an official partment of Agriculture backtag prior swine brucellosis test after a period of to or at the first market, stockyard, at least 60 days’ confinement in isola- quarantined feedlot, or slaughtering es- tion from other feral swine. tablishment they reach. Finished fed cattle. Cattle fattened on Market swine test (MST) reactor. Mar- a ration of feed concentrates to reach a ket swine test swine with a positive re- slaughter condition equivalent to that action to a swine brucellosis confirm- which would be attained on full feed atory test or other official test, if no with a high concentrate grain ration confirmatory test is performed. for 90 days. Market swine test swine. Sows and boars which have been moved to Herd. (a) All animals under common slaughtering establishments and sows ownership or supervision that are and boars which are subjected to an of- grouped on one or more parts of any ficial test for the purposes of move- single premises (lot, farm, or ranch); or ment at farms, ranches, auction mar- (b) All animals under common owner- kets, stockyards, or other assembly ship or supervision on two or more points. premises which are geographically sep- Monitored-negative feral swine popu- arated but on which animals from the lation. Feral swine indicating no evi- different premises have been inter- dence of infection (indicators would in- changed or had contact with each clude positive blood tests or clinical other. signs, such as abortion) and originating (c) For the purposes of this part, the from a specified, geographically iso- term herd does not include animals lated area (a forest area, hunting pre- that are contained within a federally serve, or swamp, for example) may be approved research facility. classified by the designated epi- Herd blood test. A blood test for bru- demiologist as a monitored-negative cellosis conducted in a herd on all cat- feral swine population. tle or bison 6 months of age or over, ex- Moved. Shipped, transported, deliv- cept steers and spayed heifers. ered, or received for movement, or oth- Herd known to be affected. Any herd in erwise aided, induced, or caused to be which any animal has been classified as moved. a brucellosis reactor and which has not Moved (movement) in interstate com- been released from quarantine. merce. Moved from the point of origin Herd not known to be affected. Any of the interstate movement to the ani- herd in which no animal has been clas- mals’ final destination, such as a sified as a brucellosis reactor or any slaughtering establishment or a farm herd in which one or more animals for breeding or raising, and including have been classified as brucellosis reac- any temporary stops for any purpose tors but which has been released from along the way, such as at a stockyard quarantine. or dealer premises for feed, water, rest, Herd of origin of swine. Any herd in or sale. which swine are farrowed and remain Official adult vaccinate. (a) Female until movement or any herd in which cattle or female bison older than the swine remain for 30 days immediately specified ages defined for official prior to movement. calfhood vaccinate and vaccinated by

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an APHIS representative, State rep- mal registered breed association reg- resentative, or accredited veterinarian istration brands or individual animal with a reduced dose approved brucella registered breed association registra- vaccine, diluted so as to contain at tion tattoos may be substituted for of- least 300 million and not more than 1 ficial eartags. billion live cells per 2 mL dose of Official eartag. An identification tag Brucella abortus Strain 19 vaccine or at providing unique identification for in- the dosage indicated on the label individual animals. An official eartag structions for other approved brucella which contains or displays an AIN with vaccines, as part of a whole herd vac- an 840 prefix must bear the U.S. shield. cination plan authorized jointly by the The design, size, shape, color, and State animal health official and the other characteristics of the official Veterinarian in Charge; and eartag will depend on the needs of the (b)(1) Permanently identified by a users, subject to the approval of the ‘‘V’’ hot brand high on the hip near the Administrator. The official eartag tailhead at least 5 by 5 centimeters (2 must be tamper-resistant and have a by 2 inches) in size, or by an official AV high retention rate in the animal. Offi- (adult vaccination) tattoo in the right cial eartags must adhere to one of the ear preceded by the quarter of the year following numbering systems: and followed by the last digit of the (a) National Uniform Eartagging Sys- year; and tem. (2) Identified with an official eartag (b) Animal identification number or individual animal registered breed (AIN). association registration brand or individual animal registered breed associa- (c) Premises-based number system. tion tattoo. The premises-based number system Official brand inspection certificate. A combines an official premises identi- document issued by an official brand fication number (PIN), as defined in inspection agency in any State which § 71.1 of this chapter, with a producer’s requires such documents for movement livestock production numbering sys- of cattle. tem to provide a unique identification Official brand recording agency. The number. The PIN and the production duly constituted body authorized by a number must both appear on the offi- State or governmental subdivision cial tag. thereof to administer laws, regula- (d) Any other numbering system ap- tions, ordinances or rules pertaining to proved by the Administrator for the the brand identification of cattle. identification of animals in commerce. Official calfhood vaccinate. (a) Female Official identification device or method. cattle or female bison vaccinated while A means of officially identifying an from 4 through 12 months of age by an animal or group of animals using de- APHIS representative, State represent- vices or methods approved by the Ad- ative, or accredited veterinarian with a ministrator, including, but not limited reduced dose approved brucella vaccine to, official tags, tattoos, and registered containing at least 2.7 billion and not brands when accompanied by a certifi- more than 10 billion live cells per 2 mL cate of inspection from a recognized dose of Brucella abortus Strain 19 vac- brand inspection authority. cine or at the dosage indicated on the Official seal. A serially numbered, label instructions for other approved metal or plastic strip, consisting of a brucella vaccines; and self-locking device on one end and a (b) Permanently identified by a tat- slot on the other end, which forms a too and by an official vaccination loop when the ends are engaged and eartag in the right ear. However, if al- which cannot be reused if opened, or a ready identified with an official eartag serially numbered, self-locking button prior to vaccination, an additional tag which can be used for this purpose. is not required. The tattoo must in- Official swine tattoo. A tattoo, conclude the U.S. Registered Shield and forming to the six-character alpha-nu- ‘‘V,’’ preceded by the quarter of the meric National Tattoo System, that year and followed by the last digit of provides a unique identification for the year of vaccination. Individual ani- each herd or lot of swine.

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Official test—(a) Classification of cattle sults of other official tests conducted and bison—(1) Standard card test. (i) A in the cooperative State-Federal lab- test to determine the brucellosis dis- oratory to give the designated epi- ease status of test-eligible cattle and demiologist additional information bison when conducted according to in- when classifying cattle and bison. structions approved by APHIS and the (iii) Standard card test results are in- State in which the test is to be con- terpreted as either negative or positive. A ducted and when conducted under the moderate to marked clumping aggluti- following circumstances: nation reaction is a positive result. (A) When conditions and time are Test-eligible cattle and bison positive such that no other test is available; or to the standard card test are classified (B) When the owner or the owner’s as brucellosis reactors. Test-eligible agent requests it because of time or cattle and bison negative to the stand- situation constraints; or ard card test are classified as brucel- (C) In specifically approved stock- losis negative. yards when the State animal health of- (2) Standard tube test (STT) or stand- ficial either: ard plate test (SPT). A test to determine (1) Designates the standard card test the brucellosis disease status of test-el- as the official test for determining the igible cattle and bison when conducted brucellosis disease status of cattle and according to instructions approved by bison in all specifically approved APHIS and the State in which the test stockyards in the State. In these is to be conducted. Cattle and bison are States, no other official test except the classified according to the following Buffered Acidified Plate Antigen test agglutination reactions: shall be used in specifically approved stockyards; or SPT OR STT CLASSIFICATION—OFFICIAL VAC- (2) Designates the standard card test CINATES VACCINATED WITH A BRUCELLA as the official test for determining the ABORTUS STRAIN 19 APPROVED BRUCELLA brucellosis disease status of non-vac- VACCINE cinated cattle or bison (the CITE ® test may be designated as a supplemental Titer Classification test for non-vaccinated cattle or bison 1:50 1:100 1:200 that test positive to the standard card ¥ ...... ¥ ...... ¥ ...... Negative. test); and designates the standard card ¥ ¥ test as the official test for determining I ...... Do. + ...... ¥ ...... ¥ ...... Do. the brucellosis disease status of official + ...... I ...... ¥ ...... Suspect. ® vaccinates and the CITE test, the + ...... + ...... ¥ ...... Do. standard plate test, or the Rivanol test + ...... + ...... I ...... Do. as supplemental tests for official vac- + ...... + ...... + ...... Reactor. cinates that test positive to the stand- ¥ No agglutination. ard card test. If supplemental tests are I Incomplete agglutination. conducted, cattle or bison that are + Complete agglutination. positive to the standard card test shall OFFICIAL VACCINATES VACCINATED WITH AN AP- be classified as brucellosis suspects if PROVED BRUCELLA VACCINE OTHER THAN A all of the supplemental tests conducted BRUCELLA ABORTUS STRAIN 19 APPROVED disclose a negative or suspect reaction, BRUCELLA VACCINE and shall be classified as brucellosis reactors if any one of the supplemental Titer tests conducted has a positive reaction; Classification or 1:50 1:100 1:200 (D) To test market cattle identifica- ¥ ...... ¥ ...... ¥ ...... Negative. tion (MCI) program test samples. Cat- I ...... ¥ ...... ¥ ...... Suspect. tle and bison which test positive to the + ...... ¥ ...... ¥ ...... Do. ¥ BAPA test or RST under the MCI pro- + ...... I ...... Do. + ...... + ...... ¥ ...... Reactor. gram must be retested using the stand- + ...... + ...... I ...... Do. ard card test or the standard plate or + ...... + ...... + ...... Do. tube agglutination test. ¥ No agglutination. (ii) Results of the standard card test I Incomplete agglutination. also may be used to supplement the re- + Complete agglutination.

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ALL CATTLE AND BISON WHICH ARE NOT (C) Less than 50 percent fixation (2 OFFICIAL VACCINATES plus) in a dilution of 1:10—brucellosis negative. Titer Classification (4) Technicon automated complement- 1:50 1:100 1:200 fixation test. A test to determine the brucellosis disease status of test-eligi- ¥ ...... ¥ ...... ¥ ...... Negative. I ...... ¥ ...... ¥ ...... Suspect. ble cattle and bison when conducted + ...... ¥ ...... ¥ ...... Do. according to instructions approved by + ...... I ...... ¥ ...... Do. APHIS and the State in which the test + ...... + ...... ¥ ...... Reactor. + ...... + ...... I ...... Do. is to be conducted. Cattle and bison are + ...... + ...... + ...... Do. classified according to the following re- ¥ No agglutination. actions: I Incomplete agglutination. (i) Cattle and bison which are not of- + Complete agglutination. ficial vaccinates: (3) Manual complement-fixation (CF) (A) Fixation in a dilution of 1:10 or test. A test to determine the brucellosis higher—brucellosis reactor; disease status of test-eligible cattle (B) Fixation in a dilution of 1:5 but and bison when conducted according to no fixation in a dilution of 1:10—brucel- instructions approved by APHIS and losis suspect; the State in which the test is to be (C) No fixation in a dilution of 1:5 or conducted. Cattle and bison are classi- lower—brucellosis negative; fied according to the following reac- (ii) Official vaccinates vaccinated tions: with a Brucella abortus Strain 19 ap- (i) Cattle and bison which are not of- proved brucella vaccine: ficial vaccinates: (A) Fixation in a dilution of 1:20 or (A) Fifty percent fixation (2 plus) in higher—brucellosis reactor; a dilution of 1:20 or higher—brucellosis (B) Fixation in a dilution of 1:10 but reactor; no fixation in a dilution of 1:20—brucel- (B) Fifty percent fixation (2 plus) in a losis suspect; dilution of 1:10 but less than 50 percent (C) Fixation in a dilution of 1:5 or fixation (2 plus) in a dilution of 1:20— less but no fixation in a dilution of brucellosis suspect; 1:10—brucellosis negative. (C) Less than 50 percent fixation (2 (iii) Official vaccinates vaccinated plus) in a dilution of 1:10—brucellosis with an approved brucella vaccine negative; other than a Brucella abortus Strain 19 (ii) Official vaccinates vaccinated approved brucella vaccine: with a Brucella abortus Strain 19 ap- (A) Fixation in a dilution of 1:10 or proved brucella vaccine: higher—brucellosis reactor; (A) Twenty-five percent fixation (1 (B) Fixation in a dilution of 1:5 but plus) in a dilution of 1:40 or higher— no fixation in a dilution of 1:10—brucel- brucellosis reactor; losis suspect; (B) Fifty percent fixation (2 plus) in a (C) No fixation in a dilution of 1:5 or dilution of 1:10 but less than 25 percent lower—brucellosis negative. fixation (1 plus) in a dilution of 1:40— (5) Rivanol test. A test to determine brucellosis suspect; the brucellosis disease status of test-el- (C) Less than 50 percent fixation (2 igible cattle and bison when conducted plus) in a dilution of 1:10—brucellosis according to instructions approved by negative. APHIS and the State in which the test (iii) Official vaccinates vaccinated is to be conducted. Cattle and bison are with an approved brucella vaccine classified according to the following other than a Brucella abortus Strain 19 agglutination reactions: approved brucella vaccine: (i) Cattle and bison which are not of- (A) Fifty percent fixation (2 plus) in ficial vaccinates: a dilution of 1:20 or higher—brucellosis (A) Complete agglutination at a titer reactor; of 1:25 or higher—brucellosis reactor; (B) Fifty percent fixation (2 plus) in a (B) Less than complete agglutination dilution of 1:10 but less than 50 percent at a titer of 1:25—brucellosis negative; fixation (2 plus) in a dilution of 1:20— (ii) Official adult vaccinates more brucellosis suspect; than 5 months after vaccination with a

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Brucella abortus Strain 19 approved bison negative to the BAPA test are brucella vaccine and official calfhood classified as brucellosis negative. Cat- vaccinates vaccinated with a Brucella tle and bison positive to the BAPA test abortus Strain 19 approved brucella shall be subjected to other official vaccine: tests to determine their brucellosis (A) Incomplete agglutination at a classification. titer of 1:100 or higher—brucellosis re- (8) Rapid screening test (RST). A test actor; to determine the brucellosis disease (B) Complete agglutination at a titer status of test-eligible cattle and bison of 1:25 or higher when the manual or in cooperative State-Federal labora- technicon automated complement-fixa- tories when conducted according to in- tion test is not conducted—brucellosis structions approved by APHIS and the reactor; State in which the test is to be con- (C) Complete agglutination at a titer ducted. RST results are interpreted as of 1:50 or less when the manual com- either negative or positive. Cattle and plement-fixation test or the technicon bison negative to the RST are classi- automated complement-fixation test is fied as brucellosis negative. Cattle and conducted and results in a classifica- bison positive to the RST shall be sub- tion of brucellosis suspect or brucel- jected to other official tests to deter- losis negative—brucellosis suspect; mine their brucellosis classification. (D) Less than complete agglutination (9) Concentration immunoassay tech- at a titer of 1:25—brucellosis negative; nology (CITE ®) test. An enzyme (iii) Official adult vaccinates less immunoassay that may be used as a di- than 5 months after vaccination with a agnostic supplement to the standard Brucella abortus Strain 19 approved card test by designated epidemiologists brucella vaccine: Less than complete agglutination at the 1:50 titer—brucel- determining the brucellosis disease losis negative. status of cattle and bison. The test must be done in accordance with the (iv) Official vaccinates vaccinated ® with an approved brucella vaccine CITE Brucella abortus Antibody Test other than a Brucella abortus Strain 19 Kit instructions, licensed by the approved brucella vaccine: United States Department of Agri- (A) Complete agglutination at a titer culture and approved as of December of 1:25 or higher—brucellosis reactor; 31, 1987, and incorporated by reference. (B) Less than complete agglutination This incorporation by reference was ap- at a titer of 1:25—brucellosis negative. proved by the Director of the Federal (6) Semen plasma test. A test to deter- Register in accordance with 5 U.S.C. mine the brucellosis disease status of 552(a) and 1 CFR part 51. Copies may be bulls used for artificial insemination obtained from AgriTech Systems, Inc., when conducted in conjunction with an 100 Fore Street, Portland, ME 04101. official serological test and according Copies may be inspected at the Animal to instructions approved by APHIS and and Plant Health Inspection Service, the State in which the test is to be Veterinary Services, Operational Sup- conducted. The classification of such port, 4700 River Road Unit 33, River- bulls shall be based on the maximum dale, Maryland 20737–1231, or at the Na- agglutination titer of either the offi- tional Archives and Records Adminis- cial serological test or the semen plas- tration (NARA). For information on ma test. the availability of this material at (7) Buffered acidified plate antigen NARA, call 202–741–6030, or go to: http:// (BAPA) test. A test to determine the www.archives.gov/federallregister/ brucellosis disease status of test-eligi- codeloflfederallregulations/ ble cattle and bison at recognized ibrllocations.html. slaughtering establishments and spe- (10) Particle concentration fluorescence cifically approved stockyards when immunoassay (PCFIA) test. An auto- conducted according to instructions mated serologic test to determine the approved by APHIS and the State in brucellosis disease status of test-eligi- which the test is to be conducted. ble cattle and bison when conducted BAPA test results are interpreted as according to instructions approved by either negative or positive. Cattle and APHIS. Cattle and bison are classified

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according to the following ratio be- read between 10 and 20 mP above the tween the test sample and a known negative control mean should be re- negative sample (S/N ratio): tested using 20 microliters of sample. If the 20-microliter sample is >20 mP S/N ratio Classification above the mean negative control, the Greater than .60 ...... Negative. sample is considered positive. If the 20- Greater than .30 but less than or Suspect. microliter sample is still in the 10 to 20 equal to .60. .30 or less ...... Positive. mP range above the mean negative control, the sample is considered sus- (11) D-Tec ® Brucella A test. An auto- pect. If the 20-microliter sample is <10 mated serologic test to determine the mP above the mean negative control, brucellosis disease status of test-eligi- the sample is considered negative. Cat- ble cattle and bison when conducted tle and bison negative to the FP assay according to instructions approved by are classified as brucellosis negative. APHIS. The degree of reactivity is Cattle and bison with positive FP measured by the ratio of the average assay results are classified as brucel- optical density of the sample to that of losis reactors, while cattle and bison the Negative Control (S/N) and is ex- with suspect FP assay results are clas- pressed as Percent Inhibition (1–S/N) × sified as brucellosis suspects. 100. The brucellosis disease status of (14) The evaluation of test results for the animals is classified according to all cattle and bison shall be the respon- the following established criteria: sibility of a designated epidemiologist Percent inhibition Classification in each State. The designated epidemiologist shall consider the animal Less than or equal to 40 percent ...... Negative. and herd history and other epidemio- Greater than 40 percent and less than Suspect. or equal to 70 percent. logic factors when determining the Greater than 70 percent ...... Reactor. brucellosis classification of cattle and bison. Deviations from the brucellosis (12) Rapid Automated Presumptive classification criteria as provided in (RAP) test. An automated serologic test this definition of official test are ac- to detect the presence of Brucella anti- ceptable when made by the designated bodies in test-eligible cattle and bison. epidemiologist. RAP test results are interpreted as ei- (i) The designated epidemiologist ther positive or negative; the results may consider the results of CITE ® are interpreted and reported by a scan- tests when evaluating the results of ning autoreader that measures alter- standard card tests of cattle and bison. ations in light transmission through (b) Classification of swine—(1) Stand- each test well and the degree of agglu- ard card test. A test to determine the tination present. Cattle and bison negative to the RAP test are classified as brucellosis disease status of swine. brucellosis negative; cattle and bison Standard card test results are inter- positive to the RAP test shall be sub- preted as either negative or positive. A jected to other official tests to deter- moderate to marked clumping aggluti- mine their brucellosis disease classi- nation reaction is a positive result. fication. Swine negative to the standard card (13) Fluorescence polarization assay test are classified as brucellosis nega- (FP assay). An automated serologic test tive. Swine positive to the standard to determine the brucellosis status of card test in a herd not known to be af- test-eligible cattle and bison when con- fected but negative to any other offi- ducted according to instructions ap- cial test or bacteriological culture for proved by APHIS. FP assays are inter- brucella are classified as brucellosis preted as either positive, negative, or suspects. Other swine positive to the suspect. A 10-microliter sample is used. standard card test are classified as bru- If a sample reads <10 millipolarization cellosis reactors. units (mP) above the mean negative (2) Standard tube test. A test to deter- control, the sample is considered nega- mine the brucellosis disease status of tive. If a sample reads >20 mP above swine. the mean negative control, the sample (i) If all of the following apply: (A) is considered positive. Samples that The swine are part of a herd not known

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to be affected; (B) No swine tested, in- (4) Rapid Automated Presumptive dividually or as part of a group, has a (RAP) test. An automated serologic test complete agglutination reaction at a to detect the presence of Brucella anti- dilution of 1:100 or higher; and (C) the bodies in test-eligible swine. RAP test swine are tested as part of a herd blood results are interpreted as either posi- test or are part of a validated brucel- tive or negative; the results are inter- losis-free herd, then the swine are clas- preted and reported by a scanning sified according to the following agglu- autoreader that measures agglutina- tination reactions: tion based on alterations in light transmission through each test well. Titer Classification Swine negative to the RAP test are 1:25 1:50 1:100 classified as brucellosis negative; swine I ...... ]— ...... ¥ ...... Negative. positive to the RAP test shall be sub- + ...... ¥ ...... ¥ ...... Do. jected to other official tests to deter- + ...... I ...... ¥ ...... Do. mine their brucellosis disease classi- + ...... + ...... ¥ ...... Do. fication. + ...... + ...... I ...... Do. (5) Fluorescence polarization assay (FP ¥ No agglutination. I Incomplete agglutination. assay). An automated serologic test to + Complete agglutination. determine the brucellosis status of test-eligible swine when conducted ac- (ii) If any of the following apply: (A) The swine are part of a herd known to cording to instructions approved by be affected; (B) Any swine tested, indi- APHIS. FP assays are interpreted as vidually or as part of a group, has a either positive, negative, or suspect. A complete agglutination reaction at a 40-microliter sample is used. If a sam- dilution of 1:100 or higher or; (C) The ple reads <10 millipolarization units swine are not part of a validated bru- (mP) above the mean negative control, cellosis-free herd and are not being the sample is considered negative. If a tested as part of a herd blood test, then sample reads >20 mP above the mean the swine are classified according to negative control, the sample is consid- the following agglutination reactions: ered positive. Samples that read between 10 and 20 mP above the negative Titer Classification control mean must be retested using 40 1:25 1:50 1:100 microliters of sample. If the 40- microliter sample is >20 mP above the I ...... ¥ ...... ¥ ...... Negative. mean negative control, the sample is ¥ ¥ + ...... Reactor. considered positive. If the 40-microliter + ...... I ...... ¥ ...... Do. + ...... + ...... ¥ ...... Do. sample is still in the 10 to 20 mP range + ...... + ...... I ...... Do. above the mean negative control, the + ...... + ...... + ...... Do. sample is considered suspect. If the 40- ¥ No agglutination. microliter sample is <10 mP above the I Incomplete agglutination. mean negative control, the sample is + Complete agglutination. considered negative. Swine with nega- (3) Particle concentration fluoresence tive FP assay results are classified as immunoassay (PCFIA). An automated brucellosis negative. Swine with posi- serologic test to determine the brucel- tive FP assay results are classified as losis disease status of test-eligible brucellosis reactors, while swine with swine when conducted according to in- suspect FP assay results are classified structions approved by the Animal and as brucellosis suspects. Plant Health Inspection Service. Swine (6) The evaluation of test results for are classified according to the fol- all swine shall be the responsibility of lowing ratios between the test sample a designated epidemiologist in each and a known negative sample (S/N State. The designated epidemiologist ratio): shall consider the animal and herd history and other epidemiologic factors S/N Ratio Classification when determining the brucellosis clas- 0.71 or greater ...... Negative. sification of swine. Deviations from the 0.51 to 0.70 ...... Suspect. brucellosis classification criteria as 0.50 or less ...... Reactor. provided in this definition of official

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test are acceptable when made by the tains the same information but not a designated epidemiologist. ‘‘permit for entry’’ or ‘‘ ‘S’ brand per- Official vaccinate. An official calfhood mit’’) issued by an APHIS representa- vaccinate or an official adult vac- tive, State representative, or accred- cinate. The accredited veterinarian, ited veterinarian which lists the own- State representative or APHIS rep- er’s name and address, points of origin resentative who performs the vaccina- and destination, number of animals tion must forward a completed official covered, purpose of the movement, any vaccination certificate for each animal reactor tag number, and one of the fol- vaccinated to the State animal health lowing: The official eartag number, in- official of the State in which the ani- dividual animal registered breed asso- mal was vaccinated. ciation registration tattoo, individual Official vaccination eartag. An APHIS animal registered breed association approved identification eartag con- registration brand, United States De- forming to the alpha-numeric National partment of Agriculture backtag (when Uniform Eartagging System which pro- applied serially, only the beginning and vides unique identification for each the ending numbers need be recorded), animal. The eartag shall have a ‘‘V’’ individual animal registered breed as- followed by 2 letters and 4 numbers. sociation registration number, or simi- States which require more official vac- lar individual identification. (A new cination eartags than the number of permit is required for each change in combinations available in the ‘‘V’’ se- destination. However, permits accom- ries of tags shall use a ‘‘T’’ or ‘‘S’’ fol- panying cattle or bison to an approved lowed by 2 letters and 4 numbers. Du- intermediate handling facility may list plicate reissue of official vaccination either the approved intermediate han- eartags shall not be made more often dling facility, a quarantined feedlot or than once each 15 years. a recognized slaughtering establish- Originate. (a) Animals will have the ment as the point of destination. If the status of the herd from which they are permit lists a quarantined feedlot or a moved if: recognized slaughtering establishment (1) They were born and maintained in as the point of destination, then the the herd since birth; or permit must list the approved inter- (2) They have been in the herd for at mediate handling facility as a tem- least 120 days. porary stopping point, and no addi- (b) Animals will have the status of tional permit is required for the subse- the State or area from which they are quent movement of the cattle or bison moved if: to the quarantined feedlot or to the (1) They were born and maintained in recognized slaughtering establish- the State or area since birth; or ment.) (2) They were previously moved from Permit for entry. A premovement au- a State or area of equal or higher class thorization for entry of cattle into a to the State or area; or State from the State animal health of- (3) They were previously moved from ficial of the State of destination. It a State or area of lower class to the State or area where they are now lo- may be oral or written. cated and have been in the new State Person. Any individual, corporation, or area for at least 120 days. company, association, firm, partner- (c) Cattle penned in a specifically ap- ship, society, or joint stock company proved stockyard with cattle from a or other legal entity. lower class State or area, in violation Postparturient. Having given birth. of the requirements set forth in § 71.20 Purebred registry association. A swine of this chapter, shall have the status of breed association formed and perpet- the State or area of lower class for any uated for the maintenance of records of subsequent movement. purebreeding of swine species for a spe- Parturient. Visibly prepared to give cific breed whose characteristics are birth or within 2 weeks of giving birth set forth in Constitutions, By-Laws, (springers). and other rules of the association. Permit. An official document (VS Qualified herd. (a) Qualification. (1) Form 1–27 or a State form which con- Any herd of cattle or bison which is in

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a quarantined area, not known to be af- (a) All cattle and bison, except steers fected, and negative to two consecutive and spayed heifers, leaving the quar- herd blood tests. The first of these two antined feedlot must (1) Be accom- herd blood tests shall be conducted not panied by a permit and move directly more than 240 days nor less than 120 to a recognized slaughtering establish- days prior to the date of classification ment; or (2) Be ‘‘S’’ branded and ac- as a qualified herd. The second herd companied by an ‘‘S’’ brand permit and blood test may not be conducted less move directly to an approved inter- than 90 days nor more than 150 days mediate handling facility and then di- after the first test. Additionally, the rectly to another quarantined feedlot second herd blood test must be within or a recognized slaughtering establish- 120 days of the date of classification as ment; or (3) Be accompanied by a per- a qualified herd; or mit issued by the State animal health (2) Any certified brucellosis-free herd official and move directly to another in a quarantined area which is negative quarantined feedlot; or (4) After being to a herd blood test 120 days before or ‘‘S’’ branded at the quarantined feed- after designation of the area as a quar- lot, be accompanied by an ‘‘S’’ brand antined area. permit and move directly to a specifi- (b) Requalification. In order to remain cally approved stockyard approved to a qualified herd, a herd must be nega- receive brucellosis exposed cattle and tive to successive requalifying herd bison and then directly to a recognized blood tests. Each requalifying test slaughtering establishment or another shall be conducted not more than 120 quarantined feedlot; or (5) After being days from the date of the preceding ‘‘S’’ branded at the quarantined feed- herd blood test. All cattle or bison lot, be accompanied by an ‘‘S’’ brand added to a qualified herd must be in- permit and move directly to a specifi- cluded in two successive herd blood cally approved stockyard approved to tests of the qualified herd to qualify as receive brucellosis exposed cattle and cattle or bison from the qualified herd. bison and then directly to an approved Quarantined area. An area that does intermediate handling facility and not meet the criteria for classification then directly to another quarantined as Class Free, Class A, Class B, or Class feedlot or a recognized slaughtering es- C. tablishment. However, finished fed cat- Quarantined feedlot.1 A confined area tle moving directly to a recognized under State quarantine approved joint- slaughtering establishment are exempt ly by the State animal health official from the permit/’’S’’ brand permit re- and the Veterinarian in Charge. Ap- quirement. proval will be granted only after a (b) The State animal health official State representative or APHIS rep- and the Veterinarian in Charge shall resentative inspects the confined area establish procedures for accounting for and determines that all cattle and all cattle and bison entering or leaving bison are secure and isolated from con- quarantined feedlots. tact with all other cattle and bison, Quarantined pasture. A confined graz- that there are facilities for identifying ing area under State quarantine ap- cattle and bison, and that there is no proved by the State animal health offi- possibility of brucellosis being me- cial, Veterinarian in Charge and the chanically transmitted from the con- Administrator. A justification of the fined area. The quarantined feedlot need for the quarantined pasture must shall be maintained for feeding cattle be prepared by the State animal health and bison for slaughter, with no provi- official and/or Veterinarian in Charge sions for pasturing or grazing. All cat- and submitted to the Administrator. tle and bison in a quarantined feedlot, An intensified brucellosis eradication except steers and spayed heifers, shall effort which produces large numbers of be treated as brucellosis exposed. brucellosis exposed cattle or bison or official adult vaccinates needing the 1 A list of quarantined feedlots in any State grazing period to reach slaughter con- may be obtained from the State animal dition would be an acceptable justifica- health official, a State representative, or an tion. Approval will be granted only APHIS representative. after a State representative or APHIS

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representative inspects the confined Rodeo bulls. Male cattle kept solely grazing area and determines that all for performance at rodeos. cattle and bison are secure and isolated ‘‘S’’ branded. Branding with a hot from contact with all other cattle and iron the letter ‘‘S’’ high on the left hip bison, that there are facilities for iden- near the tailhead and at least 5 by 5 tifying the cattle and bison, and that centimeters (2 by 2 inches) in size. there is no possibility of brucellosis ‘‘S’’ brand permit. A document pre- being mechanically transmitted from pared at the point of origin which lists the confined grazing area. The quar- the points of origin and destination, antined pasture shall be for utilizing the number of animals covered, the available forage for growth or to im- purpose of movement, and one of the prove flesh condition of cattle or bison. following: The official eartag number, No cattle or bison may be moved inter- individual animal registered breed as- state into these quarantined pastures, sociation registration tattoo, indi- which shall be restricted for use by cat- vidual animal registered breed associa- tle or bison originating within the tion registration brand, individual ani- State. All cattle or bison shall be of mal registered breed association reg- the same sex, except that neutered cat- istration number, United States De- tle and bison may share the quar- partment of Agriculture backtag (when antined pasture. All cattle and bison, applied serially, only the beginning and except steers and spayed heifers, must the ending numbers need be recorded), be ‘‘S’’ branded upon entering the quar- or similar individual identification. If antined pasture. All cattle and bison, the document is prepared at a quar- except steers and spayed heifers, leav- antined feedlot, it shall be prepared by ing the quarantined pasture must move an accredited veterinarian, a State rep- directly to a recognized slaughtering resentative, or an individual des- establishment or quarantined feedlot, ignated for that purpose by the State or directly to an approved intermediate animal health official. If the document handling facility and then directly to a is prepared at any other point of ori- recognized slaughtering establishment, gin, it shall be prepared by an accred- or directly to an approved intermediate ited veterinarian, State representative, handling facility and then directly to a or APHIS representative. (A new ‘‘S’’ quarantined feedlot and then directly brand permit is required for each to a recognized slaughtering establish- change in destination. However, ‘‘S’’ ment. The movement shall be in ac- brand permits accompanying cattle or cordance with established procedures bison to approved intermediate han- for handling brucellosis exposed cattle dling facilities may list either the ap- and bison, including issuance of ‘‘S’’ proved intermediate handling facility, brand permits prior to movement. The a quarantined feedlot, or a recognized State animal health official and Vet- slaughtering establishment as the erinarian in Charge shall establish pro- point of destination. If the ‘‘S’’ brand cedures for accounting for all cattle permit lists a quarantined feedlot or a and bison entering and leaving the recognized slaughtering establishment quarantined pasture. All brucellosis ex- as the point of destination, the ‘‘S’’ posed cattle and bison must vacate the brand permit must list the approved in- premises on or before the expiration of termediate handling facility as a tem- approval, which may not last longer porary stopping point, and no addi- than 10 months. tional ‘‘S’’ brand permit is required for Recognized slaughtering establishment.2 the subsequent movement of the cattle Any slaughtering establishment oper- or bison from the approved inter- ating under the provisions of the Fed- mediate handling facility to the quar- eral Meat Inspection Act (21 U.S.C. 601 antined feedlot or to the recognized et seq.) or a State meat inspection act. slaughtering establishment. Subse- quent movements from the quar- 2 A list of recognized slaughtering estab- antined feedlot shall be subject to re- lishments in any State may be obtained from quirements set forth in the definition an APHIS representative, the State animal of ‘‘quarantined feedlot’’ in this sec- health official, or a State representative. tion.)

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Sow. A female swine which is partu- (d) Official calfhood vaccinates of rient or postparturient. dairy breeds with partial eruption of Specifically approved stockyard.3 Prem- the first pair of permanent incisors (20 ises where cattle or bison are assem- months of age or over). bled for sale or sale purposes and which United States. All of the States. meet the standards set forth in § 71.20 United States Department of Agri- of this chapter and are approved by the culture backtag. A backtag issued by Administrator. APHIS that provides unique identifica- State. Any State, the District of Co- tion for each animal. lumbia, Puerto Rico, the Virgin Islands Validated brucellosis-free herd. (a) A of the United States, Guam, the North- swine herd not known to be infected ern Mariana Islands or any other terri- with swine brucellosis, located in a tory or possession of the United States. validated brucellosis-free State; or State animal health official. The State (b) A swine herd in a State that has official responsible for livestock and not been validated as brucellosis-free, poultry disease control and eradication provided the herd meets the conditions programs. for validation, as follows: State representative. An individual em- (1) Validation. A swine herd may be ployed in animal health work by a validated as brucellosis-free if it has State or a political subdivision thereof been found brucellosis negative after and authorized by such State or polit- either a complete-herd test (CHT) or an ical subdivision to perform the func- incremental CHT. The incremental tion involved under a memorandum of CHT may be conducted by testing all understanding with the United States breeding swine 6 months of age or older Department of Agriculture. with negative results within 365 days, Successfully closed case. Follow up of either in four 25-percent increments, an MCI reactor traceback with an epi- with those tests being conducted on demiologic investigation which results the 90th, 180th, 270th, and 360th days of in brucellosis testing or quarantine of the testing cycle, or in 10-percent in- the herd of origin, or a determination crements every 25–35 days until 100 per- by a designated brucellosis epidemiolo- cent of those swine have been tested. In gist that justification exists for not cases where unforseen circumstances testing or quarantining the herd of ori- warrant such action, the Adminis- gin. trator may approve an extension of up Swine brucellosis. The communicable to 15 days of the date on which a test disease of swine caused by Brucella suis under the 25-percent incremental herd (B. suis) biovar 1 or 3. test is to be conducted, thus allowing a Test-eligible cattle and bison. For pur- test to be conducted no later than the poses of interstate movement, test-eli- 105th, 195th, 285th, or 375th day of the gible cattle and bison are: testing cycle. No swine may be tested (a) Cattle and bison which are not of- twice during the testing cycle to com- ficial vaccinates and which have lost ply with either the 25 percent require- their first pair of temporary incisors ment or the 10 percent requirement. No (18 months of age or over), except further testing is required once 100 per- steers and spayed heifers; cent of the breeding swine have been (b) Official calfhood vaccinates 18 tested. After all breeding swine have months of age or over which are partu- tested brucellosis negative, a herd may rient or postparturient; be validated as brucellosis-free. Unless (c) Official calfhood vaccinates of the Administrator has approved an al- beef breeds or bison with the first pair ternative testing schedule, which of permanent incisors fully erupted (2 might extend the testing cycle, a herd years of age or over); and retains validated brucellosis-free status for a maximum of 365 days. (2) Maintaining validation. Validation 3 Notices containing lists of specifically ap- may be continuously maintained if a proved stockyards are published in the FED- ERAL REGISTER. Lists of specifically ap- complete herd test (CHT) is performed proved stockyards also may be obtained from once every 365 days, with negative re- the State animal health official, State rep- sults, or an incremental CHT is per- resentatives, or APHIS representatives. formed. The incremental CHT may be

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conducted by testing all breeding swine (3) Statistical analysis. Demonstrating, 6 months of age or older, with negative by a statistical analysis of all official results, within 365 days in either four swine brucellosis test results (includ- 25-percent increments, with those tests ing herd validation, MST, change-of- being conducted on the 90th, 180th, ownership, diagnostic) during the 2- 270th, and 360th days of the testing year qualification period, a surveil- cycle, or in 10-percent increments lance level equivalent or superior to every 25–35 days until 100 percent of CHT and MST testing programs dis- those swine have been tested. In cases cussed in this paragraph. where unforeseen circumstances war- (c) To maintain validation, a State rant such action, the Administrator must annually survey at least 5 per- may approve an alternative testing cent of its breeding swine, and dem- schedule under which the 25 percent or onstrate traceback to herd of origin of 10 percent incremental CHT would be at least 80 percent of all MST reactors. completed, with negative results, with- A State must demonstrate its con- in 420 days, during which time the tinuing ability to meet the criteria set herd’s validated brucellosis-free status forth in paragraph (c) of this definition would be continued. No swine may be within 36–40 months of receiving vali- tested twice during the testing cycle to dated brucellosis-free State status to comply with these requirements. No retain that status. further testing is required once 100 per- Veterinarian in Charge. The veteri- cent of the breeding swine have been nary official of the Animal and Plant tested. Health Inspection Service, United Validated brucellosis-free State. A States Department of Agriculture, who State may apply for validated-free sta- is assigned by the Administrator to su- tus when: pervise and perform the official animal (a) Any herd found to have swine bru- health work of the Animal and Plant cellosis during the 2-year qualification Health Inspection Service in the State period preceding the application has concerned. been depopulated. More than one find- Whole herd vaccination. The vaccina- ing of a swine brucellosis-infected herd tion of all female cattle and female during the qualification period dis- bison 4 months of age or over in a herd qualifies the State from validation as when authorized by the State animal brucellosis-free; and health official and the Veterinarian in (b) During the 2-year qualification Charge, and conducted in accordance period, the State has completed sur- with the definitions of official adult veillance, annually, as follows: vaccinate and official calfhood vaccinate. (1) Complete herd testing. Subjecting all swine in the State that are 6 (Approved by the Office of Management and months of age or older and maintained Budget under control number 0579–0047) for breeding purposes to an official [51 FR 32580, Sept. 12, 1986] swine brucellosis test; or (2) Market swine testing. Subjecting 20 EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 78.1, see the List of CFR percent of the State’s swine 6 months Sections Affected, which appears in the of age or older and maintained for Finding Aids section of the printed volume breeding purposes to an official swine and at www.fdsys.gov. brucellosis test, and demonstrating successful traceback of at least 80 per- § 78.2 Handling of certificates, permits, cent of market swine test (MST) reac- and ‘‘S’’ brand permits for inter- tors to the herd of origin. Blood sam- state movement of animals. ples may be collected from MST swine (a) Any certificate, permit, or ‘‘S’’ if the swine can be identified to their brand permit required by this part for herd of origin, in accordance with the interstate movement of animals § 71.19(b) of this subchapter. All MST shall be delivered to the person moving reactor herds are subject to a CHT the animals by the shipper or shipper’s within 30 days of the MST laboratory agent at the time the animals are de- report date, as determined by a des- livered for movement and shall accom- ignated epidemiologist; or pany the animals to their destination

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and be delivered to the consignee or § 78.7 Brucellosis reactor cattle. the person receiving the animals. (a) Destination. Brucellosis reactor (b) The APHIS representative, State cattle may be moved interstate only representative, or accredited veteri- for immediate slaughter as follows: narian issuing a certificate or permit (1) Directly to a recognized slaugh- required for the interstate movement tering establishment; of animals under this part, except for (2) Directly to an approved inter- permits for entry and ‘‘S’’ brand per- mediate handling facility and then di- mits, shall forward a copy thereof as rectly to a recognized slaughtering es- follows: tablishment; or (1) A copy of each certificate shall be (3) From a farm of origin directly to forwarded to the State animal health a specifically approved stockyard ap- official of the State of destination, or proved to receive brucellosis reactors to the State animal health official of and then (i) Directly to a recognized slaugh- the State of origin for forwarding to tering establishment; or the State of destination; or (ii) Directly to an approved inter- (2) A copy of each permit shall be for- mediate handling facility and then di- warded to the State animal health offi- rectly to a recognized slaughtering es- cial of the State of destination. tablishment. (Approved by the Office of Management and (b) Identification. Brucellosis reactor Budget under control number 0579–0047) cattle must be individually identified prior to moving interstate by attach- [51 FR 32580, Sept. 12, 1986, as amended at 56 ing to the left ear a metal tag bearing FR 54533, Oct. 22, 1991; 56 FR 58639, Nov. 21, a serial number and the inscription 1991] ‘‘U.S. Reactor,’’ or a metal tag bearing a serial number designated by the § 78.3 Handling in transit of cattle and bison moved interstate. State animal health official for identifying brucellosis reactors, and must be: Cattle and bison moving interstate, (1) ‘‘B’’ branded (as defined in § 78.1); except cattle and bison moved directly or to a recognized slaughtering establish- (2) Accompanied directly to slaugh- ment, approved intermediate handling ter by an APHIS or State representa- facility, or quarantined feedlot, shall tive; or be moved only in a means of convey- (3) Moved in vehicles closed with offi- ance which has been cleaned in accord- cial seals applied and removed by an ance with §§ 71.5, 71.7, 71.10, and 71.11 of APHIS representative, State represent- this chapter and, if unloaded in the ative, accredited veterinarian, or an in- course of such movement, shall be han- dividual authorized for this purpose by dled only in pens cleaned in accordance an APHIS representative. The official with the provisions of §§ 71.4, 71.7, 71.10, seal numbers must be recorded on the and 71.11 of this chapter. accompanying permit. (c) Permit. Brucellosis reactor cattle § 78.4 [Reserved] moving interstate shall be accompanied to destination by a permit. (d) Marking of records. Each person Subpart B—Restrictions on Inter- moving brucellosis reactor cattle interstate Movement of Cattle Be- state shall, in the course of interstate cause of Brucellosis movement, plainly write or stamp the words ‘‘Brucellosis Reactor’’ upon the § 78.5 General restrictions. face of any document that person pre- Cattle may not be moved interstate pares in connection with such move- except in compliance with this subpart. ment. (e) Segregation en route. Brucellosis § 78.6 Steers and spayed heifers. reactor cattle shall not be moved interstate in any means of conveyance con- Steers and spayed heifers may be taining animals which are not brucel- moved interstate without restriction losis reactors unless all the animals under this subpart. are for immediate slaughter or unless

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the brucellosis reactor cattle are kept (i) Individually identified by an offi- separate from the other animals by a cial eartag or a United States Depart- partition securely affixed to the sides ment of Agriculture backtag; of the means of conveyance. (ii) Accompanied by a permit or ‘‘S’’ (Approved by the Office of Management and brand permit; and Budget under control number 0579–0051) (iii)(A) ‘‘S’’ branded before leaving the premises from which they are to be [51 FR 32580, Sept. 12, 1986, as amended at 59 FR 67133, Dec. 29, 1994; 60 FR 48367, Sept. 19, moved interstate; or 1995] (B) ‘‘B’’ branded when a claim for indemnity is made under part 51 of this § 78.8 Brucellosis exposed cattle. chapter; or Brucellosis exposed cattle may be (C) Official adult vaccinates; or moved interstate only as follows: (D) Moved in vehicles closed with of- (a) Movement to recognized slaugh- ficial seals applied and removed by an tering establishments. (1) Finished fed APHIS representative, State represent- cattle from a quarantined feedlot may ative, accredited veterinarian, or an in- be moved interstate dividual authorized for this purpose by (i) Directly to a recognized slaugh- an APHIS representative. The official tering establishment without further seal numbers must be recorded on the restriction under this part; or accompanying permit or ‘‘S’’ brand (ii) Directly to an approved inter- permit. mediate handling facility and then di- (4) Brucellosis exposed cattle moving rectly to a recognized slaughtering es- to slaughter from a farm of origin may tablishment if accompanied by a per- be moved directly to a specifically ap- mit or ‘‘S’’ brand permit. proved stockyard approved to receive (2) Brucellosis exposed cattle may be brucellosis exposed cattle and then di- moved interstate directly to a recog- rectly to a recognized slaughtering es- nized slaughtering establishment if tablishment if such cattle are: such cattle are: (i) Individually identified by an offi- (i) Individually identified by an official eartag or United States Depart- cial eartag or a United States Depart- ment of Agriculture backtag; ment of Agriculture backtag; (ii) Accompanied by a permit or ‘‘S’’ (ii) Accompanied by a permit or ‘‘S’’ brand permit; and brand permit; and (iii)(A) ‘‘S’’ branded before leaving (iii)(A) ‘‘S’’ branded before leaving the premises from which they are to be the premises from which they are to be moved interstate; or moved interstate; or (B) ‘‘B’’ branded when a claim for in- (B) ‘‘B’’ branded when a claim for indemnity is made under part 51 of this demnity is made under part 51 of this chapter; or chapter; or (C) Official adult vaccinates; or (C) Official adult vaccinates; or (D) Accompanied directly to slaugh- (D) Moved in vehicles closed with of- ter by an APHIS or State representa- ficial seals applied and removed by an tive; or APHIS representative, State represent- (E) Moved in vehicles closed with of- ative, accredited veterinarian, or an in- ficial seals applied and removed by an dividual authorized for this purpose by APHIS representative, State represent- an APHIS representative. ative, accredited veterinarian, or an in- The official seal numbers must be re- dividual authorized for this purpose by corded on the accompanying permit or an APHIS representative. ‘‘S’’ brand permit. The official seal numbers must be re- (5) Brucellosis exposed cattle moving corded on the accompanying permit or to slaughter from a farm of origin may ‘‘S’’ brand permit. be moved directly to a specifically ap- (3) Brucellosis exposed cattle may be proved stockyard approved to receive moved interstate directly to an ap- brucellosis exposed cattle and then di- proved intermediate handling facility rectly to an approved intermediate and then directly to a recognized handling facility and then directly to a slaughtering establishment if such cat- recognized slaughtering establishment tle are: if such cattle are:

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(i) Individually identified by an offi- (c) Movement other than in accordance cial eartag or United States Depart- with paragraphs (a) and (b) of this sec- ment of Agriculture backtag; tion. Brucellosis exposed cattle for (ii) Accompanied by a permit or ‘‘S’’ which no claim for indemnity is being brand permit; and made by the owner under part 51 of this (iii)(A) ‘‘S’’ branded before leaving chapter also may be moved interstate the premises from which they are to be in accordance with § 78.10 and as fol- moved interstate; or lows: (B) ‘‘B’’ branded when a claim for in- (1) Such brucellosis exposed cattle demnity is made under part 51 of this from herds known to be affected other chapter; or than female cattle which originate in (C) Official adult vaccinates; or Class B States or areas or Class C (D) Moved in vehicles closed with official seals applied and removed by an States or areas may be moved inter- APHIS representative, State represent- state if the cattle are: ative, accredited veterinarian, or an in- (i) Under 6 months of age and weaned dividual authorized for this purpose by from brucellosis reactors or brucellosis an APHIS representative. The official exposed cows not less than 30 days im- seal numbers must be recorded on the mediately preceding interstate move- accompanying permit or ‘‘S’’ brand ment; or permit. (ii) Under 6 months of age and nurs- (b) Movement to quarantined feedlots. ing brucellosis exposed cows in a herd Brucellosis exposed cattle for which no subjected to a herd blood test within 10 claim for indemnity is being made by days prior to interstate movement; or the owner under part 51 of this chapter (iii) Official vaccinates under 1 year may be moved interstate directly to a of age from a herd following an ap- quarantined feedlot, or from a farm of proved individual herd plan. origin directly to a specifically ap- (2) Cattle moved interstate from a proved stockyard approved to receive farm of origin directly to a specifically brucellosis exposed cattle and then di- approved stockyard in accordance with rectly to a quarantined feedlot, or from § 78.9(b)(3)(iii), 78.9(c)(3)(iii), or 78.9(d)(3) a farm of origin directly to an approved of this part and subsequently deter- intermediate handling facility and then directly to a quarantined feedlot, mined to be brucellosis exposed may be or from a farm of origin directly to a moved interstate directly back to the specifically approved stockyard ap- farm of origin under the following con- proved to receive brucellosis exposed ditions: cattle and then directly to an approved (i) Prior to interstate movement, intermediate handling facility and State representatives of the State in then directly to a quarantined feedlot, which the cattle are located and the if the cattle are: State of destination advise APHIS that (1) Individually identified by an offi- such movement would not be contrary cial eartag or a United States Depart- to the laws and regulations of their re- ment of Agriculture backtag; spective States; (2) Accompanied by a permit or ‘‘S’’ (ii) Prior to interstate movement, brand permit; and the State representative of the State of (3)(i) ‘‘S’’ branded before leaving the destination agrees to quarantine the premises from which they are to be cattle on arrival and to require that all moved interstate; or test-eligible cattle on the farm of ori- (ii) Official adult vaccinates; or gin be subjected to an official test; and (iii) Moved in vehicles closed with of- (iii) The cattle are accompanied to ficial seals applied and removed by an the farm of origin by a permit. APHIS representative, State representative, accredited veterinarian, or an in- (Approved by the Office of Management and dividual authorized for this purpose by Budget under control number 0579–0051) an APHIS representative. The official [51 FR 32580, Sept. 12, 1986, as amended at 54 seal numbers must be recorded on the FR 1925, Jan. 18, 1989; 56 FR 54533, 54534, Oct. accompanying permit or ‘‘S’’ brand 22, 1991; 56 FR 65782, Dec. 18, 1991; 59 FR 67133, permit. Dec. 29, 1994; 60 FR 48367, Sept. 19, 1995]

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§ 78.9 Cattle from herds not known to tion. Such cattle may be moved inter- be affected. state other than in accordance with Male cattle which are not test eligi- paragraphs (a)(1) and (2) of this section ble and are from herds not known to be only if: affected may be moved interstate with- (i) Such cattle are moved interstate out further restriction. Female cattle from a farm of origin directly to a spe- which are not test eligible and are from cifically approved stockyard; or herds not known to be affected may be (ii) Such cattle are moved interstate moved interstate only in accordance from a farm of origin or returned inter- with § 78.10 of this part and this sec- state to a farm of origin in the course tion. Test-eligible cattle which are not of normal ranching operations, without brucellosis exposed and are from herds change of ownership, directly to or not known to be affected may be moved from another premises owned, leased, interstate only in accordance with or rented by the same individual; or § 78.10 and as follows: (a) Class Free States/areas. Test-eligi- (iii) Such cattle are moved interstate ble cattle which originate in Class Free accompanied by a certificate which States or areas, are not brucellosis ex- states, in addition to the items speci- posed, and are from a herd not known fied in § 78.1, that the cattle originated to be affected may be moved interstate in a Class Free State or area. from Class Free States or areas only as (b) Class A States/areas. Test-eligible specified below: cattle which originate in Class A (1) Movement to recognized slaughtering States or areas, are not brucellosis ex- establishments. (i) Such cattle may be posed, and are from a herd not known moved interstate directly to a recog- to be affected may be moved interstate nized slaughtering establishment or di- from Class A States or areas only as rectly to a specifically approved stock- specified below: yard and then directly to a recognized (1) Movement to recognized slaughtering slaughtering establishment without re- establishments. (i) Such cattle may be striction under this subpart. moved interstate from a farm of origin (ii) Such cattle may be moved inter- or nonquarantined feedlot directly to a state from a farm of origin directly to recognized slaughtering establishment an approved intermediate handling fa- or directly to a specifically approved cility and then directly to a recognized slaughtering establishment if accom- stockyard and then directly to a recog- panied by a permit. nized slaughtering establishment with- (iii) Such cattle may be moved inter- out restriction under this subpart. state from other than a farm of origin (ii) Such cattle may be moved inter- directly to an approved intermediate state from a farm of origin directly to handling facility and then directly to a an approved intermediate handling fa- recognized slaughtering establishment cility without restriction under this if such cattle are accompanied by a subpart. permit. (iii) Such cattle from other than a (2) Movement to quarantined feedlots. farm of origin or nonquarantined feed- Such cattle may be moved interstate lot may be moved interstate directly to without restriction under this subpart a recognized slaughtering establish- directly to a quarantined feedlot, or di- ment or directly to a specifically ap- rectly to a specifically approved stock- proved stockyard and then directly to yard and then directly to a quar- a recognized slaughtering establish- antined feedlot, or directly to a specifi- ment if identity to the Class A State or cally approved stockyard and then di- area is maintained by means of identi- rectly to an approved intermediate fication tag numbers appearing on sale handling facility and then directly to a records showing the consignor or by quarantined feedlot, or directly to an penning cattle from the farm or State approved intermediate handling facility and then directly to a quarantined or area apart from other animals. feedlot. (iv) Such cattle from other than a (3) Movement other than in accordance farm of origin may be moved interstate with paragraphs (a)(1) and (2) of this sec- accompanied by a permit.

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(A) Directly to an approved inter- (iii) Such cattle are moved interstate mediate handling facility and then di- from a farm of origin directly to a spe- rectly to a recognized slaughtering es- cifically approved stockyard and are tablishment; or subjected to an official test upon ar- (B) Directly to a specifically ap- rival at the specifically approved proved stockyard and then directly to stockyard prior to losing their identity an approved intermediate handling fa- with the farm of origin; or cility and then directly to a recognized (iv) Such cattle are moved interstate slaughtering establishment. from a farm of origin or returned inter- (2) Movement to quarantined feedlots. state to a farm of origin in the course (i) Such cattle may be moved inter- of normal ranching operations, without state from a farm of origin directly to change of ownership, directly to or a quarantined feedlot, or directly to a from another premises owned, leased, specifically approved stockyard and or rented by the same individual. then directly to a quarantined feedlot, (c) Class B States/areas. Test-eligible or directly to a specifically approved cattle which originate in Class B stockyard and then directly to an ap- States or areas, are not brucellosis ex- proved intermediate handling facility posed, and are from a herd not known and then directly to a quarantined to be affected may be moved interstate feedlot, or directly to an approved in- from Class B States or areas only termediate handling facility and then under the conditions specified below: directly to a quarantined feedlot, if the (1) Movement to recognized slaughtering identity of the farm of origin of the establishments. (i) Such cattle may be cattle is maintained by means of iden- moved interstate from a farm of origin tification tag numbers appearing on or a nonquarantined feedlot directly to sale records showing the consignor or a recognized slaughtering establish- by penning cattle from the farm of ori- ment without restriction under this gin apart from other animals. subpart. (ii) Such cattle from other than a farm of origin may be moved interstate (ii) Such cattle may be moved inter- directly to a quarantined feedlot or di- state from a farm of origin directly to rectly to a specifically approved stock- an approved intermediate handling fa- yard and then directly to a quar- cility without restriction under this antined feedlot if identity to the Class subpart. A State or area is maintained by (iii) Such cattle may be moved inter- means of identification tag numbers state from a nonquarantined feedlot di- appearing on sale records showing the rectly to an approved intermediate consignor or by penning cattle from handling facility and then directly to a one farm or State or area apart from recognized slaughtering establishment other animals. if they are accompanied by a permit or (3) Movement other than in accordance ‘‘S’’ brand permit. with paragraphs (b)(1) and (2) of this sec- (iv) Such cattle may be moved inter- tion. Such cattle may be moved interstate from a farm of origin or a non- state other than in accordance with quarantined feedlot directly to a spe- paragraphs (b)(1) and (2) of this section cifically approved stockyard and then only if: to a recognized slaughtering establish- (i) Such cattle originate in a certified ment if: brucellosis-free herd and are accom- (A) They are negative to an official panied interstate by a certificate which test conducted at the specifically ap- states, in addition to the items speci- proved stockyard and are accompanied fied in § 78.1, that the cattle originated to slaughter by a certificate or ‘‘S’’ in a certified brucellosis-free herd; or brand permit which states, in addition (ii) Such cattle are negative to an of- to the items specified in § 78.1, the test ficial test within 30 days prior to such dates and results of the official tests; interstate movement and are accom- or panied interstate by a certificate which (B) They originate from a certified states, in addition to the items speci- brucellosis-free herd and identity to fied in § 78.1, the test dates and results the certified brucellosis-free herd is of the official tests; or maintained; or

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(C) They are ‘‘S’’ branded at the spe- by a certificate or ‘‘S’’ brand permit cifically approved stockyard, accom- which states, in addition to the items panied by an ‘‘S’’ brand permit, and specified in § 78.1, the test dates and removed directly to a recognized slaugh- sults of the official tests; or tering establishment; or (B) They originate from a certified (D) They are moved from the specifi- brucellosis-free herd and identity to cally approved stockyard accompanied the certified brucellosis-free herd is by an ‘‘S’’ brand permit and in vehicles maintained; or closed with official seals applied and (C) They are ‘‘S’’ branded, accom- removed by an APHIS representative, a panied by an ‘‘S’’ brand permit, and State representative, an accredited moved directly to a recognized slaugh- veterinarian, or an individual author- tering establishment; or ized for this purpose by an APHIS rep- (D) They are accompanied by an ‘‘S’’ resentative. brand permit and moved in vehicles The official seal numbers must be re- closed with official seals applied and corded on the accompanying ‘‘S’’ brand removed by an APHIS representative, a permit. State representative, an accredited (v) Such cattle may be moved inter- veterinarian, or by an individual au- state from a farm of origin or a non- thorized for this purpose by an APHIS quarantined feedlot directly to a spe- representative. cifically approved stockyard and then The official seal numbers must be re- to an approved intermediate handling corded on the accompanying ‘‘S’’ brand facility and then directly to a recog- permit. nized slaughtering establishment if: (vii) Such cattle from other than a (A) They are negative to an official farm of origin or a nonquarantined test conducted at the specifically ap- feedlot may be moved interstate to an proved stockyard and are accompanied approved intermediate handling facil- by an ‘‘S’’ brand permit which states, ity and then directly to a recognized in addition to the items specified in slaughtering establishment only if: § 78.1, the test dates and results of the official tests; or (A) They are negative to an official (B) They originate from a certified test within 30 days prior to such inter- brucellosis-free herd, identity to the state movement and are accompanied certified brucellosis-free herd is main- by a permit or ‘‘S’’ brand permit which tained, and they are accompanied by states, in addition to the items speci- an ‘‘S’’ brand permit; or fied in § 78.1, the test dates and results (C) They are ‘‘S’’ branded at the spe- of the official tests; or cifically approved stockyard, accom- (B) They originate from a certified panied by an ‘‘S’’ brand permit, and brucellosis-free herd, identity to the moved directly to an approved inter- certified brucellosis-free herd is main- mediate handling facility; or tained, and they are accompanied by (D) They are accompanied by an ‘‘S’’ an ‘‘S’’ brand permit; or brand permit and moved in vehicles (C) They are ‘‘S’’ branded, accom- closed with official seals applied and panied by an ‘‘S’’ brand permit, and removed by an APHIS representative, moved directly to an approved inter- State representative, accredited veteri- mediate handling facility; or narian, or an individual authorized for (D) They are accompanied by an ‘‘S’’ this purpose by an APHIS representa- brand permit and moved in vehicles tive. The official seal numbers must be closed with official seals applied and recorded on the accompanying ‘‘S’’ removed by an APHIS representative, brand permit. State representative, accredited veteri- (vi) Such cattle from other than a narian, or an individual authorized for farm of origin or a nonquarantined this purpose by an APHIS representa- feedlot may be moved interstate to a tive. The official seal numbers must be recognized slaughtering establishment recorded on the accompanying ‘‘S’’ only if: brand permit. (A) They are negative to an official (2) Movement to quarantined feedlots. test within 30 days prior to such inter- (i) Such cattle may be moved interstate movement and are accompanied state from a farm of origin directly to:

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(A) A quarantined feedlot if such cat- (3) Movement other than in accordance tle are ‘‘S’’ branded upon arrival at the with paragraphs (c)(1) and (2) of this sec- quarantined feedlot; or tion. Such cattle may be moved inter- (B) A specifically approved stockyard state other than in accordance with and then directly to a quarantined paragraphs (c)(1) and (2) of this section feedlot or directly to an approved in- only if: termediate handling facility and then (i) Such cattle originate in a certified directly to a quarantined feedlot, if the brucellosis-free herd and are accom- cattle are ‘‘S’’ branded upon arrival at panied interstate by a certificate which the specifically approved stockyard states, in addition to the items speci- and are accompanied to the quar- fied in § 78.1, that the cattle originated antined feedlot by an ‘‘S’’ brand per- in a certified brucellosis-free herd; or mit; or (ii) Such cattle are negative to an of- (C) An approved intermediate han- ficial test within 30 days prior to inter- dling facility and then directly to a state movement, have been issued a quarantined feedlot, if the cattle are permit for entry, and are accompanied ‘‘S’’ branded upon arrival at the ap- interstate by a certificate which proved intermediate handling facility states, in addition to the items speci- and are accompanied to the quar- fied in § 78.1, the test dates and results antined feedlot by an ‘‘S’’ brand per- of the official tests; or mit; or (iii) Such cattle are moved interstate (D) A quarantined feedlot, a specifi- from a farm of origin directly to a spe- cally approved stockyard and then di- cifically approved stockyard and are rectly to a quarantined feedlot, or an subjected to an official test upon ar- approved intermediate handling facil- rival at the specifically approved ity and then directly to a quarantined stockyard prior to losing their identity feedlot if the cattle are accompanied with the farm of origin; or by an ‘‘S’’ brand permit and moved in (iv) Such cattle are moved interstate vehicles closed with official seals ap- from a farm of origin or returned inter- plied and removed by an APHIS rep- state to a farm of origin in the course resentative, State representative, ac- of normal ranching operations, without credited veterinarian, or an individual change of ownership, directly to or authorized for this purpose by an from another premises owned, leased or APHIS representative. The official seal rented by the same individual, and (A) numbers must be recorded on the ac- The cattle being moved originate from companying ‘‘S’’ brand permit. a herd in which (1) All the cattle were (ii) Such cattle from other than a negative to a herd blood test within 1 farm of origin may be moved interstate year prior to the interstate movement; to a quarantined feedlot if: (2) Any cattle added to the herd after (A) They are negative to an official such herd blood test were negative to test within 30 days prior to such move- an official test within 30 days prior to ment and are accompanied by a certifi- the date the cattle were added to the cate which states, in addition to the herd; (3) None of the cattle in the herd items specified in § 78.1, the test dates have come in contact with any other and results of the official tests; or cattle; and (B) The cattle are accom- (B) They are ‘‘S’’ branded, accompanied interstate by a document which panied by an ‘‘S’’ brand permit, and states the dates and results of the herd moved directly to a quarantined feed- blood test and the name of the labora- lot; or tory in which the official tests were (C) They are accompanied by an ‘‘S’’ conducted. brand permit and moved in vehicles (v) The State animal health officials closed with official seals applied and of the State of origin and State of des- removed by an APHIS representative, tination may waive the requirements State representative, accredited veteri- of paragraph (c)(3)(iv) of this section in narian, or an individual authorized for writing. this purpose by an APHIS representa- (d) Class C States/areas. All female tive. The official seal numbers must be cattle and test-eligible male cattle recorded on the accompanying ‘‘S’’ which originate in Class C States or brand permit. areas, are not brucellosis exposed, and

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are from a herd not known to be af- quarantined feedlot directly to a spe- fected may be moved interstate from cifically approved stockyard and then Class C States or areas only under the to an approved intermediate handling conditions specified below: facility and then directly to a recog- (1) Movement to recognized slaughtering nized slaughtering establishment if: establishments. (i) Such cattle may be (A) They are negative to an official moved interstate from a farm of origin test conducted at the specifically ap- or a nonquarantined feedlot directly to proved stockyard and are accompanied a recognized slaughtering establish- by an ‘‘S’’ brand permit which states, ment without restriction under this in addition to the items specified in subpart. § 78.1, the test dates and results of the (ii) Such cattle may be moved inter- official tests; or state from a farm of origin directly to an approved intermediate handling fa- (B) They originate from a certified cility without restriction under this brucellosis-free herd, identity to the subpart. certified brucellosis-free herd is main- (iii) Such cattle may be moved inter- tained, and they are accompanied by state from a nonquarantined feedlot dian ‘‘S’’ brand permit; or rectly to an approved intermediate (C) They are ‘‘S’’ branded at the spe- handling facility and then directly to a cifically approved stockyard, accom- recognized slaughtering establishment panied by an ‘‘S’’ brand permit, and if they are accompanied by a permit or moved directly to an approved inter- ‘‘S’’ brand permit. mediate handling facility; or (iv) Such cattle may be moved inter- (D) They are accompanied by an ‘‘S’’ state from a farm of origin or a non- brand permit and moved in vehicles quarantined feedlot directly to a spe- closed with official seals applied and cifically approved stockyard and then removed by an APHIS representative, to a recognized slaughtering establish- State representative, accredited veteri- ment if: narian, or an individual authorized for (A) They are negative to an official this purpose by an APHIS representa- test conducted at the specifically ap- tive. The official seal numbers must be proved stockyard and are accompanied recorded on the accompanying ‘‘S’’ by a certificate or ‘‘S’’ brand permit brand permit. which states, in addition to the items (vi) Such cattle from other than a specified in § 78.1, the test dates and re- farm of origin or a nonquarantined sults of the official tests; or feedlot may be moved interstate to a (B) They originate from a certified recognized slaughtering establishment brucellosis-free herd and identity to only if: the certified brucellosis-free herd is (A) They are negative to an official maintained; or (C) They are ‘‘S’’ branded at the spe- test within 30 days prior to such inter- cifically approved stockyard, accom- state movement and are accompanied panied by an ‘‘S’’ brand permit, and by a certificate or ‘‘S’’ brand permit moved directly to a recognized slaugh- which states, in addition to the items tering establishment; or specified in § 78.1, the test dates and re- (D) They are moved from the specifi- sults of the official tests; or cally approved stockyard accompanied (B) They originate from a certified by an ‘‘S’’ brand permit and in vehicles brucellosis-free herd and identity to closed with official seals applied and the certified brucellosis-free herd is removed by an APHIS representative, a maintained; or State representative, an accredited (C) They are ‘‘S’’ branded, accom- veterinarian, or an individual author- panied by an ‘‘S’’ brand permit, and ized for this purpose by an APHIS rep- moved directly to a recognized slaugh- resentative. tering establishment; or The official seal numbers must be re- (D) They are accompanied by an ‘‘S’’ corded on the accompanying ‘‘S’’ brand brand permit and moved in vehicles permit. closed with official seals applied and (v) Such cattle may be moved inter- removed by an APHIS representative, a state from a farm of origin or a non- State representative, an accredited

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veterinarian, or by an individual au- and are accompanied to the quar- thorized for this purpose by the APHIS antined feedlot by an ‘‘S’’ brand per- representative. mit; or The official seal numbers must be re- (D) A quarantined feedlot, a specifi- corded on the accompanying ‘‘S’’ brand cally approved stockyard and then di- permit. rectly to a quarantined feedlot, or an (vii) Such cattle from other than a approved intermediate handling facil- farm of origin or a nonquarantined ity and then directly to a quarantined feedlot may be moved interstate to an feedlot if the cattle are accompanied approved intermediate handling facil- by an ‘‘S’’ brand permit and moved in ity and then directly to a recognized vehicles closed with official seals ap- slaughtering establishment only if: plied and removed by an APHIS rep- (A) They are negative to an official resentative, State representative, ac- test within 30 days prior to such inter- credited veterinarian, or an individual state movement and are accompanied authorized for this purpose by an by a permit or ‘‘S’’ brand permit which APHIS representative. The official seal states, in addition to the items speci- numbers must be recorded on the ac- fied in § 78.1, the test dates and results companying ‘‘S’’ brand permit. of the official tests; or (ii) Such cattle from other than a (B) They originate from a certified farm of origin may be moved interstate brucellosis-free herd, identity to the to a quarantined feedlot if: certified brucellosis-free herd is main- (A) They are negative to an official tained, and they are accompanied by test within 30 days prior to such move- an ‘‘S’’ brand permit; or ment and are accompanied by a certifi- (C) They are ‘‘S’’ branded, accom- cate which states, in addition to the panied by an ‘‘S’’ brand permit, and items specified in § 78.1, the test dates moved directly to an approved inter- and results of the official tests; or mediate handling facility; or (B) They are ‘‘S’’ branded, accom- (D) They are accompanied by an ‘‘S’’ panied by an ‘‘S’’ brand permit, and brand permit and moved in vehicles moved directly to a quarantined feed- closed with official seals applied and lot; or removed by an APHIS representative, (C) They are accompanied by an ‘‘S’’ State representative, accredited veteri- brand permit and moved in vehicles narian, or an individual authorized for closed with official seals applied and this purpose by an APHIS representa- removed by an APHIS representative, tive. The official seal numbers must be State representative, accredited veteri- recorded on the accompanying ‘‘S’’ narian, or an individual authorized for brand permit. this purpose by an APHIS representa- (2) Movement to quarantined feedlots. tive. The official seal numbers must be (i) Such cattle may be moved inter- recorded on the accompanying ‘‘S’’ state from a farm of origin directly to: brand permit. (A) A quarantined feedlot if such cat- (3) Movement other than in accordance tle are ‘‘S’’ branded upon arrival at the with paragraphs (d)(1) or (2) of this sec- quarantined feedlot; or tion. Such cattle may be moved inter- (B) A specifically approved stockyard state other than in accordance with and then directly to a quarantined paragraphs (d)(1) or (2) of this section feedlot, or directly to an approved in- only if such cattle originate in a cer- termediate handling facility and then tified brucellosis-free herd and are ac- directly to a quarantined feedlot, if the companied interstate by a certificate cattle are ‘‘S’’ branded upon arrival at which states, in addition to the items the specifically approved stockyard specified in § 78.1 of this part, that the and are accompanied to the quar- cattle originated in a certified brucel- antined feedlot by an ‘‘S’’ brand per- losis-free herd. mit; or (Approved by the Office of Management and (C) An approved intermediate han- Budget under control number 0579–0051) dling facility and then directly to a [51 FR 32580, Sept. 12, 1986, as amended at 54 quarantined feedlot, if the cattle are FR 1925, Jan. 18, 1989; 56 FR 54533, 54534, Oct. ‘‘S’’ branded upon arrival at the ap- 22, 1991; 56 FR 58638, Nov. 21, 1991; 59 FR 67133, proved intermediate handling facility Dec. 29, 1994; 60 FR 48368, Sept. 19, 1995]

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§ 78.10 Official vaccination of cattle (c) Female cattle born after January moving into and out of Class B and 1, 1984, which are 4 months of age or Class C States or areas. over must be official vaccinates to (a) Female dairy cattle born after move interstate out of a Class C State January 1, 1984, which are 4 months of or area 4 inder § 78.9(d)(3) of this part. age or over must be official vaccinates Female cattle from a certified brucel- to move interstate into or out of a losis-free herd that are eligible for offi- Class B State or area 4 unless they are cial calfhood vaccination and required moved interstate directly to a recog- by this paragraph to be officially vac- nized slaughtering establishment or cinated may be moved interstate from quarantined feedlot, or directly to an a farm of origin directly to a specifi- approved intermediate handling facil- cally approved stockyard and be offi- ity and then directly to a recognized cially vaccinated upon arrival at the slaughtering establishment, or directly specifically approved stockyard. to an approved intermediate handling [51 FR 32580, Sept. 12, 1986, as amended at 54 facility and then directly to a quar- FR 1926, Jan. 18, 1989; 56 FR 58638, Nov. 21, antined feedlot and then directly to a 1991] recognized slaughtering establishment, or directly to an approved intermediate § 78.11 Cattle moved to a specifically handling facility and then directly to a approved stockyard not in accord- quarantined feedlot and then directly ance with this part. to a recognized slaughtering establish- Cattle, except brucellosis reactors ment. Female cattle eligible for offi- and brucellosis exposed cattle, which cial calfhood vaccination and required are moved interstate to a specifically by this paragraph to be officially vac- approved stockyard but fail to comply cinated may be moved interstate from with the requirements of this part for a farm of origin directly to a specifi- release from the specifically approved cally approved stockyard and be offi- stockyard may be moved from the specially vaccinated upon arrival at the cifically approved stockyard only as specifically approved stockyard. follows: (b) Female cattle born after January (a) With the concurrence of the State 1, 1984, which are 4 months of age or animal health officials of the State of over must be official vaccinates to origin and State of destination, di- move into a Class C State or area 4 un- rectly back to the farm of origin ac- less they are moved interstate directly companied by a permit; or to a recognized slaughtering (b) Directly to an approved inter- establishiment, or directly to an ap- mediate handling facility and then di- proved intermediate handling facility rectly to a recognized slaughtering es- and then directly to a recognized tablishment or directly to an approved slaughtering establishment, or directly intermediate handling facility and to an approved intermediate handling then directly to a quarantined feedlot facility and then directly to a quar- and then directly to a recognized antined feedlot and then directly to a slaughtering establishment if such cat- recognized slaughtering establishment. tle are ‘‘S’’ branded and accompanied Female cattle eligible for official by an ‘‘S’’ brand permit; or calfhood vaccination and required by (c) Directly to a recognized slaugh- this paragraph to be officially vac- tering establishment if such cattle are cinated may be moved interstate from (1) ‘‘S’’ branded and accompanied by a farm of origin directly to a specifi- an ‘‘S’’ brand permit; or cally approved stockyard and be offi- (2) Accompanied by an ‘‘S’’ brand cially vaccinated upon arrival at the permit and moved in vehicles closed specifically approved stockyard. with official seals applied and removed by an APHIS representative, State rep- 4 Female cattle imported into the United resentative, an accredited veteri- States may be exempted from the vaccina- narian, or an individual authorized for tion requirements of this paragraph with the this purpose by an APHIS representa- concurrence of the State animal health offi- tive. cial of the State of destination. This concurrence is required prior to the importation of The official seal numbers must be re- the cattle into the United States. corded on the ‘‘S’’ brand permit; or

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(d) Directly to a quarantined feedlot ‘‘S’’ brand permit which states, in addi- if such cattle are ‘‘S’’ branded and action to the items specified in § 78.1, the companied by an ‘‘S’’ brand permit. test dates and results of the official (Approved by the Office of Management and tests; or Budget under control number 0579–0047) (iii) Cattle from qualified herds in a [51 FR 32580, Sept. 12, 1986, as amended at 56 quarantined area may be moved inter- FR 54534, Oct. 22, 1991; 56 FR 58638, 58639, Nov. state from a farm of origin directly to 21, 1991] a specifically approved stockyard and then directly to an approved inter- § 78.12 Cattle from quarantined areas. mediate handling facility and then di- Not withstanding any provisions in rectly to a recognized slaughtering es- the regulations to the contrary, cattle tablishment or directly to an approved may be moved interstate from a quar- intermediate handling facility and antined area only in accordance with then directly to a quarantined feedlot § 78.10 and this section. and then directly to a recognized (a) Steers and spayed heifers. Steers slaughtering establishment if they are and spayed heifers may be moved inter- negative to an official test within 30 state without restriction under this days prior to such interstate move- section. ment and are accompanied by a permit (b) Brucellosis reactor cattle. Brucel- losis reactor cattle may be moved or ‘‘S’’ brand permit which states, in interstate in accordance with § 78.7. addition to the items specified in § 78.1, (c) Brucellosis exposed cattle. Brucel- the test dates and results of the official losis exposed cattle may be moved tests; or interstate in accordance with § 78.8(a) (iv) Cattle from qualified herds in a or (b). quarantined area may be moved inter- (d) Movement from qualified herds. Cat- state in accordance with § 78.8(a). tle from qualified herds in any quar- (2) Movement to quarantined feedlots. antined area may be moved interstate (i) Cattle from qualified herds in a only as follows: quarantined area may be moved inter- (1) Movement to recognized slaughtering state from a farm of origin directly to establishments. (i) Cattle from qualified a quarantined feedlot, or directly to a herds in a quarantined area may be specifically approved stockyard and moved interstate from a farm of origin then directly to a quarantined feedlot, directly to a recognized slaughtering or directly to an approved intermediate establishment or directly to a specifically approved stockyard and then di- handling facility and then directly to a rectly to a recognized slaughtering es- quarantined feedlot if the cattle are tablishment if they are negative to an negative to an official test within 30 official test within 30 days prior to days prior to such interstate move- such interstate movement and are ac- ment and are accompanied by a certifi- companied by a certificate or ‘‘S’’ cate which states, in addition to the brand permit which states, in addition items specified in § 78.1 of this part, the to the items specified in § 78.1, the test test dates and results of the official dates and results of the official tests; tests; or or (ii) Cattle from qualified herds in a (ii) Cattle from qualified herds in a quarantined area may be moved in ac- quarantined area may be moved inter- cordance with § 78.8(b). state from a farm of origin directly to (3) Movement other than in accordance an approved intermediate handling fa- with paragraph (d)(1) or (2) of this sec- cility and then directly to a recognized tion. Cattle from qualified herds in a slaughtering establishment or directly quarantined area may be moved inter- to an approved intermediate handling state other than in accordance with facility and then directly to a quar- paragraph (d)(1) or (2) of this section, antined feedlot and then directly to a either directly from a farm of origin or recognized slaughtering establishment if they are negative to an official test from a farm of origin through no more within 30 days prior to such interstate than one specifically approved stock- movement and are accompanied by an yard if

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(i) The cattle, except official vac- (4) A certificate accompanies each cinates less than 1 year of age and cat- interstate movement of the bull; and tle less than 6 months of age, are nega- (5) A permit for entry is issued for tive to an official test within 30 days each interstate movement of the bull. prior to such interstate movement; and (b) A bull that would qualify as a (ii) The cattle are accompanied inter- rodeo bull, but that is used for breeding state by a certificate which states, in purposes during the 365 days following addition to the items specified in § 78.1, the date of being tested, may be moved the test dates and results of the official interstate only if the bull meets the retests when such tests are required. quirements for cattle in this subpart. (e) Movement from herds which are not qualified. Cattle from herds known to (Approved by the Office of Management and be affected or from herds which are not Budget under control number 0579–0047) qualified in any quarantined area may [56 FR 58639, Nov. 21, 1991, as amended at 67 be moved interstate only in accordance FR 70310, Nov. 22, 2002; 69 FR 64650, Nov. 8, with § 78.8(a) or (b). 5 2004] (Approved by the Office of Management and §§ 78.15–78.19 [Reserved] Budget under control number 0579–0051) [51 FR 32580, Sept. 12, 1986, as amended at 56 Subpart C—Restrictions on Inter- FR 58638, Nov. 21, 1991; 59 FR 67133, Dec. 29, state Movement of Bison Be- 1994] cause of Brucellosis § 78.13 Other movements. § 78.20 General restrictions. The Administrator may, upon request in specific cases, permit the Bison may not be moved interstate interstate movement of cattle not oth- except in compliance with this subpart. erwise provided for in this subpart, § 78.21 Bison steers and spayed heif- under such conditions as the Adminis- ers. trator may prescribe in each case to prevent the spread of brucellosis. The Bison steers and spayed heifers may Administrator shall promptly notify be moved interstate without restric- the State animal health officials of the tion under this subpart. States involved of any such action. § 78.22 Brucellosis reactor bison. [51 FR 32580, Sept. 12, 1986, as amended at 56 (a) Destination. Brucellosis reactor FR 54534, Oct. 22, 1991] bison may be moved interstate only for § 78.14 Rodeo bulls. immediate slaughter as follows: (1) Directly to a recognized slaugh- (a) A rodeo bull that is test-eligible tering establishment; and that is from a herd not known to (2) Directly to an approved inter- be affected may be moved interstate if: mediate handling facility and then di- (1) The bull is classified as brucel- rectly to a recognized slaughtering es- losis negative based upon an official test conducted less than 365 days before tablishment; or the date of interstate movement: Pro- (3) From a farm of origin directly to vided, however, That the official test is a specifically approved stockyard ap- not required for a bull that is moved proved to receive brucellosis reactors only between Class Free States; and then (2) The bull is identified with an offi- (i) Directly to a recognized slaugh- cial eartag or any other official identi- tering establishment; or fication device or method approved by (ii) Directly to an approved inter- the Administrator; mediate handling facility and then di- (3) There is no change of ownership rectly to a recognized slaughtering es- since the date of the last official test; tablishment. (b) Identification. Brucellosis reactor bison must be individually identified 5 A herd which is not qualified in a quarantined area may become a qualified herd prior to moving interstate by attach- upon compliance with the provisions set ing to the left ear a metal tag bearing forth in § 78.1 in the definition of ‘‘qualified a serial number and the inscription herd.’’ ‘‘U.S. Reactor,’’ or a metal tag bearing

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a serial number designated by the proved to receive brucellosis exposed State animal health official for identi- bison and then fying brucellosis reactors, and must be: (i) Directly to a recognized slaugh- (1) ‘‘B’’ branded (as defined in § 78.1); tering establishment; or or (ii) Directly to an approved inter- (2) Accompanied directly to slaugh- mediate handling facility and then di- ter by an APHIS or State representa- rectly to a recognized slaughtering es- tive; or tablishment. (3) Moved in vehicles closed with offi- (b) Movement to quarantined feedlots. cial seals applied and removed by an Brucellosis exposed bison may be APHIS representative, State represent- moved directly to a quarantined feed- ative, accredited veterinarian, or an in- lot or, from a farm of origin, directly dividual authorized for this purpose by to a specifically approved stockyard an APHIS representative. The official approved to receive brucellosis exposed seal numbers must be recorded on the bison and then directly to a quar- accompanying permit. antined feedlot. Such bison shall be ac- (c) Permit. Brucellosis reactor bison companied by a permit or ‘‘S’’ brand moving interstate shall be accom- permit. panied to destination by a permit. (c) Movement other than in accordance (d) Marking of records. Each person with paragraphs (a) or (b) of this section. moving brucellosis reactor bison inter- Brucellosis exposed bison which are state shall, in the course of interstate from herds known to be affected, but movement, plainly write or stamp the which are not part of a herd being de- words ‘‘Brucellosis Reactor’’ upon the populated under Part 51 of this chap- face of any document that person pre- ter, may move without restriction if pares in connection with such move- the bison: ment. (1) Are under 6 months of age and (e) Segregation en route. Brucellosis were weaned from brucellosis reactor reactor bison shall not be moved inter- or brucellosis exposed bison not less state in any means of conveyance con- than 30 days immediately preceding taining animals which are not brucel- interstate movement; or losis reactors unless all of the animals (2) Are under 6 months of age and are for immediate slaughter or unless nursing brucellosis exposed bison in a the brucellosis reactor bison are kept herd subjected to a herd blood test separate from the other animals by a within 10 days prior to interstate partition securely affixed to the sides movement; or of the means of conveyance. (3) Are official vaccinates under 1 year of age from a herd following an (Approved by the Office of Management and Budget under control number 0579–0051) approved individual herd plan. [51 FR 32580, Sept. 12, 1986, as amended at 59 (Approved by the Office of Management and FR 67133, Dec. 29, 1994; 60 FR 48368, Sept. 19, Budget under control number 0579–0051) 1995] [51 FR 32580, Sept. 12, 1986, as amended at 59 FR 67133, Dec. 29, 1994] § 78.23 Brucellosis exposed bison. Brucellosis exposed bison may be § 78.24 Bison from herds not known to moved interstate only as follows: be affected. (a) Movement to recognized slaugh- Bison from herds not known to be af- tering establishments. Brucellosis ex- fected may be moved interstate only as posed bison may be moved interstate follows: for slaughter accompanied by a permit (a) Movement to recognized slaugh- or ‘‘S’’ brand permit and as follows: tering establishments. Bison from herds (1) Directly to a recognized slaugh- not known to be affected may be moved tering establishment or directly to an directly to a recognized slaughtering approved intermediate handling facil- establishment without restriction ity and then directly to a recognized under this subpart. slaughtering establishment; or (b) Movement to quarantined feedlots. (2) From a farm of origin directly to Bison from herds not known to be af- a specifically approved stockyard ap- fected may be moved directly to a

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quarantined feedlot without restriction §§ 78.26–78.29 [Reserved] under this subpart. (c) Movement from public zoo to public Subpart D—Restrictions on Inter- zoo. Bison from herds not known to be state Movement of Swine Be- affected may be moved from a zoo cause of Brucellosis owned by a governmental agency to another such zoo if handled in accordance § 78.30 General restrictions. with § 78.3. (a) Brucellosis reactor swine, brucel- (d) Movement other than in accordance losis exposed swine, feral swine, sows, with paragraphs (a), (b), or (c) of this sec- and boars may not be moved interstate tion. Bison from herds not known to be or in interstate commerce except in affected may be moved interstate other compliance with this subpart. than in accordance with paragraphs (b) Each person who causes the move- (a), (b), or (c) of this section only as ment of swine in interstate commerce follows: is responsible for the identification of (1) Such bison under 6 months of age the swine as required by this subpart. may be moved interstate when accom- No such person shall remove or tamper panied by a certificate. with or cause the removal of or tam- (2) Such bison which are official vac- pering with an identification tattoo or cinates under 2 years of age and are not approved swine identification tag re- parturient or postparturient may be quired in this subpart except at the moved interstate when accompanied by time of slaughter, or as may be author- a certificate. ized by the Administrator upon request (3) Such bison may be moved inter- in specific cases and under such condi- state if they are negative to an official tions as the Administrator may impose test within 30 days prior to such move- to ensure continuing identification. ment and are accompanied by a certifi- (c)(1) Feral swine may be moved cate which states, in addition to the interstate directly to slaughter if they items specified in § 78.1, the dates and do not come into physical contact with results of the official tests. any domestic swine or other livestock. (4) Such bison may be moved inter- (2) Feral swine from monitored-nega- state if they originate in a certified tive populations may be moved interstate other than directly to slaughter brucellosis-free herd and are accom- if accompanied by a permit issued by panied by a certificate which states, in the APHIS representative or the State addition to the items specified in § 78.1, animal health official in the State of that the bison originated in a certified origin. brucellosis-free herd. (3) Feral swine found negative to an (Approved by the Office of Management and official test within the 30 days prior to Budget under control number 0579–0047) the interstate movement may be moved interstate other than directly to [51 FR 32580, Sept. 12, 1986, as amended at 56 slaughter if accompanied by a permit FR 58639, Nov. 21, 1991] issued by the APHIS representative or § 78.25 Other movements. the State animal health official in the State of origin. The Administrator may, upon request in specific cases, permit the [51 FR 32580, Sept. 12, 1986, as amended at 56 interstate movement of bison not oth- FR 54534, Oct. 22, 1991; 59 FR 18952, Apr. 21, 1994] erwise provided for in this subpart, under such conditions as the Adminis- § 78.31 Brucellosis reactor swine. trator may prescribe in each case to prevent the spread of brucellosis. The (a) Destination. Brucellosis reactor Administrator shall promptly notify swine may be moved interstate only for immediate slaughter as follows: the State animal health officials of the (1) Directly to a recognized slaugh- States involved of any such action. tering establishment; or [51 FR 32580, Sept. 12, 1986, as amended at 56 (2) Directly to a stockyard posted FR 54534, Oct. 22, 1991] under the Packers and Stockyards Act,

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as amended (7 U.S.C. 181 et seq.), or di- herd known to be affected only if such rectly to a market agency or dealer swine are individually identified by at- registered under the Packers and taching to the left ear a metal tag Stockyards Act, for sale to a recog- bearing a serial number and the in- nized slaughtering eatablishment in ac- scription, ‘‘U.S. Reactor,’’ or a metal cordance with the following require- tag bearing a serial number designated ments: by the State animal health official for (b) Identification. Brucellosis reactor identifying brucellosis reactors. swine shall be individually identified by attaching to the left ear a metal tag (Approved by the Office of Management and Budget under control number 0579-0051) bearing a serial number and the inscription, ‘‘U.S. Reactor,’’ or a metal [59 FR 12533, Mar. 17, 1994, as amended at 59 tag bearing a serial number designated FR 67133, Dec. 29, 1994] by the State animal health official for identifying brucellosis reactors. § 78.33 Sows and boars. (c) Permit. Brucellosis reactor swine (a) Sows and boars may be moved in shall be accompanied to destination by interstate commerce for slaughter or a permit. for sale for slaughter if they are identi- (d) Marking of records. Each person fied in accordance with § 71.19 of this moving brucellosis reactor swine inter- chapter either: state shall, in the course of interstate (1) Before being moved in interstate movement, plainly write or stamp the commerce and before being mixed with words ‘‘Brucellosis Reactor’’ upon the swine from any other source; or face of any document that person pre- (2) After being moved in interstate pares in connection with such move- commerce but before being mixed with ment. swine from any other source only if (e) Segregation en route. Brucellosis they have been moved directly from reactor swine shall not be moved inter- their herd of origin to: state in any means of conveyance con- (i) A recognized slaughtering estab- taining animals which are not brucel- lishment; or losis reactors unless all of the animals (ii) A stockyard, market agency, or in the shipment are for immediate dealer operating under the Packers and slaughter, or unless the brucellosis re- Stockyards Act, as amended (7 U.S.C. actor swine are kept separate from 181 et seq.). other animals by a partition securely (b) Sows and boars may be moved in affixed to the sides of the means of con- interstate commerce for breeding only veyance. if they are identified in accordance (Approved by the Office of Management and with § 71.19 of this chapter before being Budget under control number 0579–0051) moved in interstate commerce and be- [51 FR 32580, Sept. 12, 1986, as amended at 59 fore being mixed with swine from any FR 67133, Dec. 29, 1994] other source, and the sows and boars either: § 78.32 Brucellosis exposed swine. (1) Are from a validated brucellosis- (a) Brucellosis exposed swine may be free herd or a validated brucellosis-free moved interstate only if accompanied State and are accompanied by a certifi- by a permit and only for immediate cate that states, in addition to the slaughter as follows: items specified in § 78.1, that the swine (1) Directly to a recognized slaugh- originated in a validated brucellosis- tering establishment; or free herd or a validated brucellosis-free (2) Directly to a stockyard posted State; or under the Packers and Stockyards Act, (2) Have tested negative to an official as amended (7 U.S.C. 181 et seq.), or di- test conducted within 30 days prior to rectly to a market agency or dealer interstate movement and are accom- registered under the Packers and panied by a certificate that states, in Stockyards Act, for sale to a recog- addition to the items specified in § 78.1, nized slaughtering establishment. the dates and results of the official (b) Brucellosis exposed swine from a tests. herd known to be affected with brucel- (c) Sows and boars may be moved in losis may be moved interstate from the interstate commerce for purposes other

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than slaughter or breeding without re- case of any reclassification to a lower striction under this subpart if they are class, reclassification as a quarantined identified in accordance with § 71.19 of State or area, or removal of validated this chapter. brucellosis-free status, the State ani- [62 FR 27936, May 22, 1997] mal health official of the State involved will be notified of such reclassi- § 78.34 Other movements. fication or removal, and will be given The Administrator may, upon re- an opportunity to present objections quest in specific cases, permit the and arguments to the Administrator movement in interstate commerce of prior to the reclassification or removal swine not otherwise provided for in taking place. this subpart under such conditions as [51 FR 32580, Sept. 12, 1986, as amended at 53 the Administrator may prescribe in FR 2222, Jan. 27, 1988; 56 FR 54533, Oct. 22, each case to prevent the spread of bru- 1991; 56 FR 55803, Oct. 30, 1991] cellosis. The Administrator shall promptly notify the State animal § 78.41 State/area classification. health officials of the States involved (a) Class Free. Alabama, Alaska, Ari- of any such action. zona, Arkansas, California, Colorado, [51 FR 32580, Sept. 12, 1986, as amended at 56 Connecticut, Delaware, Florida, Geor- FR 54534, Oct. 22, 1991] gia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, §§ 78.35–78.39 [Reserved] Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Mis- Subpart E—Designation of souri, Montana, Nebraska, Nevada, Brucellosis Areas New Hampshire, New Jersey, New Mex- ico, New York, North Carolina, North § 78.40 Designation of States/areas. Dakota, Ohio, Oklahoma, Oregon, The Administrator may amend Pennsylvania, Puerto Rico, Rhode Is- §§ 78.41 and 78.42 to reclassify States land, South Carolina, South Dakota, and areas as Class Free, Class A, Class Tennessee, Texas, Utah, Vermont, Vir- B, Class C, or quarantined when the gin Islands, Virginia, Washington, West Administrator determines that the Virginia, Wisconsin, and Wyoming. States or areas meet the appropriate (b) Class A. None. definitions in § 78.1. The Administrator (c) Class B. None. may approve the division of a State into two brucellosis classification [51 FR 32580, Sept. 12, 1986] areas upon finding that: (a) The State EDITORIAL NOTE: For FEDERAL REGISTER ci- has legislative and regulatory author- tations affecting § 78.41, see the List of CFR ity for maintaining separate areas; (b) Sections Affected, which appears in the The State has committed resources to Finding Aids section of the printed volume enforcing the different requirements in and at www.fdsys.gov. each area; (c) The State has an effec- § 78.42 Quarantined areas. tive method for monitoring and controlling movement of cattle across the None. intrastate boundary; (d) The State has defined the intrastate boundary by § 78.43 Validated brucellosis-free county lines or by recognizable geo- States. graphic features, such as rivers and Alabama, Alaska, Arizona, Arkansas, highways; and (e) Each area of the California, Colorado, Connecticut, State meets the standards for the bru- Delaware, Florida, Georgia, Hawaii, cellosis classification requested. The Idaho, Illinois, Indiana, Iowa, Kansas, Administrator may amend § 78.43 to re- Kentucky, Louisiana, Maine, Mary- classify States as validated brucellosis- land, Massachusetts, Michigan, Min- free States or remove such status when nesota, Mississippi, Missouri, Montana, the Administrator determines that Nebraska, Nevada, New Hampshire, such States meet or do not meet the New Jersey, New Mexico, New York, standards of a validated brucellosis- North Carolina, North Dakota, Ohio, free State as defined in § 78.1. In the Oklahoma, Oregon, Pennsylvania,

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Puerto Rico, Rhode Island, South Caro- with the first 3 being the country code lina, South Dakota, Tennessee, Texas, (840 for the United States), the alpha Utah, Vermont, Virgin Islands, Vir- characters USA, or the numeric code ginia, Washington, West Virginia, Wis- assigned to the manufacturer of the consin, Wyoming. identification device by the Inter- [53 FR 4382, Feb. 16, 1988; 53 FR 21979, June 13, national Committee on Animal Record- 1988] ing. The AIN beginning with the 840 prefix may be used only on animals EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 78.43, see the List of CFR born in the United States. Sections Affected, which appears in the APHIS representative. An individual Finding Aids section of the printed volume employed by APHIS in animal health and at www.fdsys.gov. activities who is authorized by the Ad- ministrator to perform the function in- PART 79—SCRAPIE IN SHEEP AND volved. GOATS Approved laboratory. A laboratory approved by the Administrator in accord- Sec. ance with § 54.11 of this chapter to con- 79.1 Definitions. duct one or more scrapie tests, or geno- 79.2 Identification of sheep and goats in type tests, on one or more tissues. interstate commerce. 79.3 General restrictions. Area veterinarian in charge. The vet- 79.4 Designation of scrapie-positive ani- erinary official of APHIS who is as- mals, high-risk animals, exposed ani- signed by the Administrator to super- mals, suspect animals, exposed flocks, vise and perform the official animal infected flocks, noncompliant flocks, and health work of APHIS in the State con- source flocks; notice to owners. cerned. 79.5 Issuance of certificates. 79.6 Standards for States to qualify as Con- Blackfaced sheep. Any purebred suf- sistent States. folk, hampshire, shropshire or cross 79.7 Waiver of requirements for scrapie con- thereof, any non-purebred sheep known trol pilot projects. to have suffolk, hampshire, or shrop- AUTHORITY: 7 U.S.C. 8301–8317; 7 CFR 2.22, shire ancestors, and any non-purebred 2.80, and 371.4. sheep of unknown ancestry with a black face, except commercial hair SOURCE: 66 FR 43990, Aug. 21, 2001, unless otherwise noted. sheep. Breed association and registries. Orga- § 79.1 Definitions. nizations listed in § 151.9 of this chapter Accredited veterinarian. A veteri- that maintain the permanent records narian approved by the Administrator of ancestry or pedigrees of animals (in- in accordance with part 161 of this cluding the animal’s sire and dam), in- chapter to perform functions specified dividual identification of animals, and in subchapters B, C, and D of this chap- ownership of animals. ter. Certificate. An official document Administrator. The Administrator of issued in accordance with § 79.5 by an the Animal and Plant Health Inspec- APHIS representative, State represent- tion Service or any employee of the ative, or accredited veterinarian at the United States Department of Agri- point of origin of an interstate move- culture authorized to act for the Ad- ment of animals. ministrator. Commercial hair sheep. Any commer- Animal. A sheep or goat. cial sheep with hair rather than wool Animal and Plant Health Inspection that is either a full-blooded hair sheep Service (APHIS). The Animal and Plant or that resulted from the cross of a Health Inspection Service of the United hair sheep with a whitefaced wool States Department of Agriculture. sheep. Animal identification number (AIN). A Commercial sheep or goat. Any animal numbering system for the official iden- from a flock from which animals are tification of individual animals in the moved only either directly to slaughter United States providing a nationally or through slaughter channels to unique identification number for each slaughter or any animal that is raised animal. The AIN contains 15 digits, only for meat or fiber production and

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that is not registered with a sheep or Electronic implant. Any radio fre- goat registry or used for exhibition. quency identification implant device Commingle, commingled, commingling. approved for use in the scrapie program Animals grouped together and having by the Administrator. The Adminis- physical contact with each other, in- trator will approve an electronic im- cluding contact through a fence, but plant after determining that it is tam- not limited contacts. Commingling per resistant, not harmful to the ani- also includes sharing the same section mal, and readable by equipment avail- in a transportation unit where there is able to APHIS and State representa- physical contact. tives. Consistent State. (1) A State that the Exposed animal. (1) Any animal that Administrator has determined con- has been in the same flock at the same ducts an active State scrapie control time as a scrapie-positive female ani- program that either: mal, excluding limited contacts; or (i) Meets the requirements of § 79.6; or (2) Any animal born in a flock after a (ii) Effectively enforces a State de- scrapie-positive animal was born into signed plan that the Administrator de- that flock or lambed in that flock, if termines is at least as effective in con- born before that flock completes the trolling scrapie as the requirements of requirements of a flock plan; or § 79.6. (3) Any animal that was commingled (2) The Administrator has deter- with a scrapie-positive female animal mined the following States to be Con- during or up to 30 days after she sistent States: Alabama, Alaska, Ari- lambed, kidded, or aborted, or while a zona, Arkansas, California, Colorado, visible vaginal discharge was present, Connecticut, Delaware, Florida, Geor- or that was commingled with any other gia, Hawaii, Idaho, Illinois, Indiana, scrapie-positive female animal for 24 Iowa, Kansas, Kentucky, Louisiana, hours or more, including during activi- Maine, Maryland, Massachusetts, ties such as shows and sales or while in Michigan, Minnesota, Mississippi, Mis- marketing channels; or souri, Montana, Nebraska, Nevada, (4) Any animal in a noncompliant New Hampshire, New Jersey, New Mex- flock. ico, New York, North Carolina, North Exposed flock. Any flock in which a Dakota, Ohio, Oklahoma, Oregon, scrapie-positive animal was born or Pennsylvania, Rhode Island, South lambed. Any flock that currently con- Carolina, South Dakota, Tennessee, tains a female high-risk, exposed, or Texas, Utah, Vermont, Virginia, Wash- suspect animal, or that once contained ington, West Virginia, Wisconsin, and a female high-risk, exposed, or suspect Wyoming. animal that lambed in the flock and Designated scrapie epidemiologist. An from which tissues were not submitted epidemiologist who has demonstrated for official testing and found negative. the knowledge and ability to perform A flock that has completed a post-ex- the functions required and who has posure management and monitoring been selected by the State animal plan following the exposure will no health official and the area veteri- longer be an exposed flock. narian in charge. The regional epi- Flock. All animals that are main- demiologist and the APHIS National tained on a single premises and all ani- Scrapie Program Coordinator must mals under common ownership or su- concur in the selection and appoint- pervision on two or more premises with ment of the designated scrapie epi- animal interchange between the prem- demiologist. The designated scrapie ises. Changes in ownership of part or epidemiologist must satisfactorily all of a flock do not change the iden- complete training designated by tity of the flock or the regulatory re- APHIS. quirements applicable to the flock. Direct movement to slaughter. Trans- Animals maintained temporarily on a ported to a facility for slaughter, with- premises for activities such as shows out stops or unloading except for feed- and sales or while in marketing chan- ing and watering during which the ani- nels are not a flock. More than one mals are not commingled with any flock may be maintained on a single other animals. premises if:

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(1) The flocks are enrolled as sepa- the requirements in § 54.8(a)(f) of this rate flocks in the SFCP; or chapter. (2) A State or APHIS representative High-risk animal. A sexually intact determines, based upon examination of animal, excluding male sheep that flock records, that: have tested RR at codon 171 and AA at (i) There is no interchange of animals codon 136 using an official genotype between the flocks; test, that is: (ii) The flocks never commingle and (1) The progeny of a scrapie-positive are kept at least 30 feet apart at all dam; or times or are separated by a solid wall (2) Born in the same flock during the through, over, or under which fluids cannot pass and through which contact same lambing season as progeny of a cannot occur; scrapie-positive dam, unless the prog- (iii) The flocks have separate flock eny of the scrapie-positive dam are records and identification; from separate contemporary lambing (iv) The flocks have separate lambing groups; or facilities, including buildings and pas- (3) Born in the same flock during the tures, and a pasture or building used same lambing season that a scrapie- for lambing by one flock is not used by positive animal was born, or during the other flock at any time; and any subsequent lambing season, if born (v) The flocks do not share equip- before that flock completes the re- ment without cleaning and disinfection quirements of a flock plan; or in accordance with § 54.7(e) of this (4) An exposed female sheep that has chapter. Additional guidance on ac- not tested QR, HR, or RR at codon 171 ceptable means of cleaning and dis- using an official genotype test. infection is also available in the Inconsistent State. Any State other Scrapie Flock Certification Program than a Consistent State. standards and the Scrapie Eradication Infected flock. The flock of origin of a Uniform Methods and Rules. female animal that a State or APHIS Flock of origin. The flock in which an representative has determined to be a animal most recently resided in which it either was born, gave birth, or was scrapie-positive animal; or any flock in used for breeding purposes. The deter- which a State or APHIS representative mination of an animal’s flock of origin has determined that a scrapie-positive may be based either on the physical female animal has resided unless an presence of the animal in the flock, the epidemiologic investigation conducted presence of official identification on by a State or APHIS representative the animal traceable to the flock, the shows that the animal did not lamb or presence of other identification on the abort in the flock. A flock will no animal that is listed on the bill of sale, longer be considered an infected flock or other evidence, such as registry after it has completed the require- records. ments of a flock plan. Flock plan. A written flock manage- Interstate commerce. Trade, traffic, ment agreement signed by the owner of transportation, or other commerce be- a flock, the accredited veterinarian, if tween a place in a State and any place one is employed by the owner, and a outside of that State, or between State or APHIS representative in points within a State but through any which each participant agrees to un- place outside that State. dertake actions specified in the flock Limited contacts. Incidental contacts plan to control the spread of scrapie between animals from different flocks from, and eradicate scrapie in, an in- off the flock’s premises such as at fairs, fected flock or source flock or to reduce the risk of the occurrence of shows, exhibitions and sales; between scrapie in a flock that contains a high- ewes being inseminated, flushed, or im- risk or an exposed animal. As part of a planted; or between rams at ram test flock plan, the flock owner must pro- or collection stations. Embryo transfer vide the facilities and personnel needed and artificial insemination equipment to carry out the requirements of the and surgical tools must be sterilized flock plan. The flock plan must include between animals for these contacts to

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be considered limited contacts. Lim- from an infected, source, or exposed ited contacts do not include any con- flock. The term brand includes official tact, incidental or otherwise, with ani- brand registry brands on eartags in mals in the same flock or with an ani- those States whose brand law or regu- mal during or up to 30 days after she lation recognizes brands placed on lambed, kidded or aborted or when eartags as official brands. Low-risk there is any visible vaginal discharge. commercial sheep may only exist in a Limited contacts do not include any State where scrapie has not been diag- activity where uninhibited contact oc- nosed in the previous 10 years in com- curs, such as sharing an enclosure, mercial whitefaced, whitefaced cross, sharing a section of a transport vehi- or commercial hair sheep that were not cle, or residing in other flocks for commingled with female blackfaced breeding or other purposes. Examples sheep. of limited contacts may be found in the Low-risk goat. A goat that is not a Scrapie Flock Certification Program scrapie-positive, suspect, high-risk, or standards. exposed animal, that has not been com- Live-animal screening test. Any test for mingled with sheep, and that is from: the diagnosis of scrapie in a live ani- (1) A State in which scrapie has not mal that is approved by the Adminis- trator as usually reliable but not defin- been identified in a goat during the itive for diagnosing scrapie, and that is previous 10 years; conducted in a laboratory approved by (2) A State in which scrapie has been the Administrator. 1 identified in a goat during the previous Low-risk commercial sheep. Commer- 10 years, but the scrapie-positive goat cial whitefaced, whitefaced cross, or was not born in the State and resided commercial hair sheep from a flock in the State for less than 54 months with no known risk factors for scrapie, and did not kid while in the State; or, including any exposure to female (3) A State in which scrapie has been blackfaced sheep, that are identified identified in a goat during the previous with a legible permanent brand or 10 years, and the scrapie-positive goat earnotch pattern registered with an of- was commingled with sheep, but flock ficial brand registry and that are not records allowed a complete epidemio- scrapie-positive, suspect, high-risk, or logic investigation to be completed and exposed animals and are not animals all resulting infected, source, and exposed goat herds have completed flock 1 The names and addresses of laboratories plans and are in compliance with post- approved by the Administrator to conduct exposure monitoring plans. live-animal screening tests will be published National Scrapie Database. A database in the Notices Section of the FEDERAL REG- designated by the Administrator in ISTER. A list of approved laboratories is also which APHIS and State animal health available upon request from the Animal and Plant Health Inspection Service, Veterinary agencies cooperatively enter data con- Services, National Animal Health Programs cerning scrapie outbreaks, flocks and Staff, 4700 River Road Unit 43, Riverdale, MD premises affected by scrapie, individual 20737–1235. State, Federal, and university lab- animal identification and premises oratories will be approved by the Adminis- identification data, and other data to trator when he or she determines that the support the Scrapie Eradication Pro- laboratory: (a) Employs personnel trained by gram and the Scrapie Flock Certifi- the National Veterinary Services Labora- cation Program. tories assigned to supervise the testing; (b) follows standard test protocols; (c) meets Noncompliant flock. (1) Any source or check test proficiency requirements; and (d) infected flock whose owner declines to will report all test results to State and Fed- enter into a flock plan or post-exposure eral animal health officials. Before the Ad- management and monitoring plan ministrator may withdraw approval of any agreement within 30 days of being so laboratory for failure to meet any of these designated, or whose owner is not in conditions, the Administrator will give writ- compliance with either agreement; ten notice of the proposed withdrawal to the director of the laboratory, and will give the (2) Any exposed flock whose owner director an opportunity to respond. If there fails to make animals available for are conflicts as to any material fact, a hear- testing within 60 days of notification, ing will be held to resolve the conflicts. or as mutually agreed, or whose owner

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fails to submit required postmortem gram. Examples are listed in samples; § 79.2(a)(2). (3) Any flock whose owner has mis- Official identification device or method. represented, or who employs a person A means of officially identifying an who has misrepresented, the scrapie animal or group of animals using de- status of an animal or any other infor- vices or methods approved by the Ad- mation on a certificate, permit, owner ministrator, including, but not limited statement, or other official document to, official tags, tattoos, and registered within the last 5 years; or brands when accompanied by a certifi- (4) Any flock whose owner or man- cate of inspection from a recognized ager has moved, or who employs a per- brand inspection authority. son who has moved, an animal in viola- Official test. Any test for the diag- tion of this chapter within the last 5 nosis of scrapie in a live or dead animal years. that is approved by the Administrator Official eartag. An identification tag for that use and conducted either at an providing unique identification for in- approved laboratory or at the National dividual animals. An official eartag Veterinary Services Laboratories. which contains or displays an AIN with Owner. A person, partnership, com- an 840 prefix must bear the U.S. shield. pany, corporation, or any other legal The design, size, shape, color, and entity who has legal or rightful title to animals, whether or not they are sub- other characteristics of the official ject to a mortgage. eartag will depend on the needs of the Owner statement. A written statement users, subject to the approval of the by the owner that includes the owner’s Administrator. The official eartag name, signature, address, and phone must be tamper-resistant and have a number, date the animals left the flock high retention rate in the animal. Offi- of origin, the premises identification cial eartags must adhere to one of the number assigned to the premises, the following numbering systems: number of animals, the premises por- (1) National Uniform Eartagging Sys- tion of the premises identification if tem. premises identification is used, and a (2) Animal identification number statement that the animals were either (AIN). born or were used for breeding purposes (3) Premises-based number system. on the premises to which the premises The premises-based number system identification is assigned. combines an official premises identi- Ownership brand. A unique perma- fication number (PIN), as defined in nent legible brand or earnotch pattern this section, with a producer’s live- applied to an animal that indicates stock production numbering system to ownership by a particular person when provide a unique identification num- the brand pattern is registered with a ber. The PIN and the production num- State’s official brand recording agency. ber must both appear on the official Permit. An official document issued in tag. connection with the interstate move- (4) Any other numbering system ap- ment of animals (VS Form 1–27 or a proved by the Administrator for the State form that contains the same in- identification of animals in commerce. formation) that is issued by an APHIS Official genotype test. Any test to de- representative, State representative, or termine the genotype of a live or dead an accredited veterinarian authorized animal that is conducted at either an to sign such permits. A new permit is approved laboratory or at the National required for each change in destination Veterinary Services Laboratories, for an animal. A permit lists the own- when the animal is officially identified er’s name and address; points of origin and the samples used for the test are and destination; number of animals collected and shipped to the laboratory covered; purpose of the movement; by either an accredited veterinarian or whether the animals are from an ex- a State or APHIS representative. posed, noncompliant, infected, or Official identification. Identification source flock; whether the animal is a mark or device approved by APHIS for high-risk, exposed, scrapie-positive, or use in the Scrapie Eradication Pro- scrapie suspect animal; transportation

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vehicle license number or other identi- The premises identification number fication number; and seal number (if a may consist of: seal is required). A permit also lists all (1) The State’s two-letter postal ab- official identification on the animals breviation followed by the premises’ covered, including the official eartag assigned number; or number, individual animal registered (2) A seven-character alphanumeric breed association registration tattoo, code, with the right-most character individual animal registered breed as- being a check digit. The check digit sociation registration brand, United number is based upon the ISO 7064 Mod States Department of Agriculture 36/37 check digit algorithm. backtag (when applied serially, only Scrapie Eradication Program. The co- the beginning and the ending numbers operative State-Federal program ad- need be recorded), individual animal ministered by APHIS and Consistent registered breed association registra- States to control and eradicate scrapie. tion number, or any other form of offi- Scrapie Eradication Uniform Methods cial identification present on the ani- and Rules (UM&R). Cooperative proce- mal. dures and standards adopted by APHIS Premises identification. An APHIS ap- and Consistent States for controlling proved eartag, backtag, or legible tat- and eradicating scrapie. The UM&R too bearing the premises identification will be reviewed at least annually by number (PIN), as defined in this sec- representatives of the livestock indus- tion, or a flock identification number, try, appropriate State and Federal or a legible permanent brand or ear agencies, and the public and will be notch pattern registered with an offi- drafted, revised, and published as need- cial brand registry. Premises identi- ed by APHIS. fication may be used when official indi- Scrapie Flock Certification Program vidual animal identification is re- (SFCP). The cooperative Federal-State- quired, if the premises identification industry voluntary program for the method either includes a unique ani- control of scrapie conducted in accord- mal number or is used in conjunction ance with subpart B of part 54 of this with the producer’s livestock produc- chapter. tion numbering system to provide a Scrapie Flock Certification Program unique identification number and standards. Cooperative procedures and where, if brands or ear notches are standards adopted by APHIS and State Scrapie Certification Boards for reduc- used, the animals are accompanied by ing the incidence and controlling the an official brand inspection certificate. spread of scrapie through flock certifi- Clearly visible and/or legible paint cation. 2 brands may be used on animals moving Scrapie-positive animal. An animal for directly to slaughter and on animals which a diagnosis of scrapie has been moving for grazing or other manage- made by the National Veterinary Serv- ment purposes without change in own- ices Laboratories or another labora- ership. tory authorized by the Administrator Premises identification number (PIN). A to conduct scrapie tests in accordance nationally unique number assigned by with this chapter, through: a State, Tribal, and/or Federal animal (1) Histopathological examination of health authority to a premises that is, central nervous system (CNS) tissues in the judgment of the State, Tribal, from the animal for characteristic mi- and/or Federal animal health author- croscopic lesions of scrapie; ity, a geographically distinct location (2) The use of proteinase-resistant from other premises. The premises protein analysis methods including but identification number is associated not limited to immunohistochemistry with an address, geospatial coordi- and/or western blotting on CNS and/or nates, and/or other location descriptors which provide a verifiably unique loca- 2 tion. The premises identification num- Individual copies of the SFCP standards may be obtained on the World Wide Web at ber may be used in conjunction with a URL http://www.aphis.usda.gov/vs, or from the producer’s own livestock production Animal and Plant Health Inspection Service, numbering system to provide a unique National Animal Health Programs Staff, 4700 identification number for an animal. River Road Unit 43, Riverdale, MD 20737–1235.

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peripheral tissue samples from a live or cation Uniform Methods and Rules. a dead animal for which a given meth- The flock owner must maintain ade- od has been approved by the Adminis- quate records to document which ani- trator for use on that tissue; mals were maintained in each contem- (3) Bioassay; porary lambing group and to document (4) Scrapie associated fibrils (SAF) when cleaning and disinfection was detected by electron microscopy; or performed and who supervised it. (5) Any other test method approved Slaughter channels. Animals in by the Administrator in accordance slaughter channels include any animal with § 54.10 of this chapter. 3 that is sold, transferred, or moved ei- Separate contemporary lambing groups. ther directly to a slaughter facility, to To be a separate contemporary an individual for custom slaughter, or lambing group, the group must be for feeding for the express purpose of maintained separately such that the improving the animals’ condition for animals cannot come into physical movement to slaughter. Any sexually contact with other lambs, kids, ewes or intact animal that is commingled with does or birth fluids or placenta from breeding animals or that has been bred other ewes or does. This separate main- is not in slaughter channels. When sell- tenance must preclude contact through ing animals for slaughter, owners a fence, during lambing and for 60 days should note on the bill of sale that the following the date the last lamb or kid animals are sold only for slaughter. is born in a lambing season, and must Source flock. A flock in which a State preclude using the same lambing facil- or APHIS representative has deter- ity as other ewes or does, unless the mined that at least one animal was lambing facility is cleaned and dis- born that was diagnosed as a scrapie- infected under supervision by an positive animal at an age of 72 months APHIS representative, State represent- or less. The determination that an ani- ative, or an accredited veterinarian be- mal was born in a flock will be based tween lambings in accordance with on such information as the presence of § 54.7(e) of this chapter. Additional official identification on the animal guidance on acceptable means of clean- traceable to the flock, the presence of ing and disinfection is also available in other identification on the animal that the Scrapie Flock Certification Pro- is listed on the bill of sale, or other evi- gram standards and the Scrapie Eradi- dence, such as registry records, to show that a scrapie-positive animal was born 3 The names and addresses of laboratories in the flock, combined with the ab- approved by the Administrator to conduct sence of records indicating that the tests are published in the Notices Section of animal was purchased from outside and the FEDERAL REGISTER. A list of approved added to the flock. If DNA from the laboratories is also available upon request from the Animal and Plant Health Inspec- animal was previously collected by an tion Service, Veterinary Services, National accredited veterinarian and stored at Animal Health Programs Staff, 4700 River an approved genotyping laboratory, or Road Unit 43, Riverdale, MD 20737–1235. if DNA collection and storage are re- State, Federal, and university laboratories quired for breed registration and the will be approved by the Administrator when breed registration has appropriate safe- he or she determines that the laboratory: (a) guards in place to ensure the integrity Employs personnel trained by the National of the banking process, the owner may Veterinary Services Laboratories assigned to supervise the testing; (b) follows standard request verification of the animal’s test protocols; (c) meets check test pro- identity based on DNA comparison if ficiency requirements; and (d) will report all adequate records and identification test results to State and Federal animal have been maintained by the owner and health officials. Before the Administrator the repository to show that the may withdraw approval of any laboratory for archived DNA is that of the animal failure to meet any of these conditions, the that has been traced to the flock. The Administrator must give written notice of owner will be responsible for all costs the proposed withdrawal to the director of the laboratory and must give the director an for the DNA comparison. A flock will opportunity to respond. If there are conflicts no longer be a source flock after it has as to any material fact, a hearing will be completed the requirements of a flock held to resolve the conflict. plan.

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State. Each of the 50 States, the Dis- tact with another flock, and from trict of Columbia, the Northern Mar- which animals are moved only to an- iana Islands, Puerto Rico, and all terri- other terminal feedlot or directly to tories or possessions of the United slaughter. States. (3) Records of all animals entering State representative. An individual em- and leaving a terminal feedlot must be ployed in animal health activities by a maintained for 1 year after the animal State or a political subdivision of a leaves the feedlot and must include the State and who is authorized by the person from whom the animals were State or political subdivision to per- acquired and the slaughtering facility form the function involved. in which they were slaughtered. Suspect animal. An animal will be des- Records must be made available for in- ignated a suspect animal in accordance spection by an APHIS or State rep- with § 79.4 if it is: resentative upon request. (1) A sheep or goat that exhibits any United States. All of the States. of the following possible signs of Unofficial test. Any test for the diag- scrapie and that has been determined nosis of scrapie or for the detection of to be suspicious for scrapie by an ac- the proteinase resistant protein associ- credited veterinarian or a State or ated with scrapie in a live or dead ani- APHIS representative: Weight loss de- mal that either has not been approved spite retention of appetite; behavioral by the Administrator or that was not abnormalities; pruritus (itching); wool conducted at an approved laboratory or pulling; biting at legs or side; lip at the National Veterinary Services smacking; motor abnormalities such as Laboratories. incoordination, high stepping gait of forelimbs, bunny hop movement of rear [66 FR 43990, Aug. 21, 2001, as amended at 69 legs, or swaying of back end; increased FR 64650, Nov. 8, 2004; 72 FR 39306, July 18, sensitivity to noise and sudden move- 2007; 73 FR 54062, Sept. 18, 2008] ment; tremor, ‘‘star gazing,’’ head pressing, recumbency, or other signs of § 79.2 Identification of sheep and goats in interstate commerce. neurological disease or chronic wasting. (a) No sheep or goat that is required (2) A sheep or goat that has tested to be individually identified or prem- positive for scrapie or for the pro- ises identified by § 79.3 may be sold, teinase resistant protein associated transported, received for transpor- with scrapie on a live-animal screening tation, or offered for sale or transpor- test or any other test, unless the ani- tation in interstate commerce unless mal is designated a scrapie-positive each sheep or goat is identified in ac- animal. cordance with this section. (3) A sheep or goat that has tested in- (1) The sheep or goat must be identi- conclusive or suggestive on an official fied to its flock of origin and, for an test for scrapie. animal born after January 1, 2002, to Terminal feedlot. (1) A dry lot ap- its flock of birth, by the owner of the proved by a State or APHIS represent- flock or his or her agent; at whichever ative or an accredited veterinarian au- of the following points in commerce thorized to perform this function where comes first, Except that; animals born animals are separated from all other after January 1, 2002, may be moved animals by at least 30 feet at all times interstate direct to slaughter without or are separated by a solid wall identification to flock of birth until through, over, or under which fluids June 1, 2003, and animals that cannot cannot pass and contact cannot occur be identified to their flock of origin be- and from which animals are moved cause Consistent States have exempted only to another terminal feedlot or di- them from flock of origin identifica- rectly to slaughter; or tion in intrastate commerce in accord- (2) A pasture when approved by and ance with § 79.6(a)(10)(i) may be moved maintained under the supervision of interstate with only individual animal the State and in which only nonpreg- identification traceable to the State of nant animals are permitted, where origin and to the owner of the animals there is no direct fence-to-fence con- at the time they were so identified:

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(i) The point of first commingling of are moving to an approved livestock the sheep or goats in interstate com- market in accordance with paragraph merce with sheep or goats from any (a)(1)(iii) of this section or to an ap- other flock of origin; proved slaughter plant in accordance (ii) Upon unloading of the sheep or with paragraph (a)(1)(v) of this section. goats in interstate commerce at any (2) The sheep or goats must be identi- livestock market, except a market de- fied by one of the following means of scribed in paragraph (a)(1)(iii) of this identification, and must remain so section; identified until they reach their final (iii) Upon leaving a livestock market destination: that has been approved in accordance (i) Electronic implants for animals with this chapter to handle sheep and required to be identified by the SFCP, goats in interstate commerce and that when used in a flock participating in has agreed to act as an agent for the the SFCP and when accompanied by a owner to apply official identification certificate or owner statement that in- to the animals. In such cases the ani- cludes the electronic implant numbers mals must be: and the name of the chip manufac- (A) Moved to the market and main- turer; tained until officially identified in dis- (ii) Official eartags, including tags tinguishable groups identifiable to approved for use in the SFCP or their flocks of origin and when re- APHIS-approved premises identifica- quired their flock of birth by means of tion number eartags when combined partitions or other such maintenance; with a unique animal identification and, number; (B) Accompanied by an owner state- (iii) United States Department of Ag- ment that contains the information riculture backtags or official premises needed to officially identify the ani- identification backtags that include a mals to their flock of origin and, when unique animal identification number, required, their flock of birth; when used on sheep or goats moving di- (iv) Upon transfer of ownership of the rectly to slaughter and when applied sheep or goats in interstate commerce; within 3 inches of the poll on the dorsal (v) In the case of animals shipped di- surface of the head or neck; rectly to slaughter at a slaughter plant (iv) Legible official registry tattoos that has agreed to act as an agent for that have been recorded in the book of the owner to apply official identifica- record of a sheep or goat registry asso- tion to the animals, upon arrival of the ciation when the animal is accom- sheep or goats in interstate commerce panied by either a registration certifi- at the slaughter plant. In such cases cate or a certificate of veterinary in- the animals must be: spection. These tattoos may also be (A) Moved to the slaughter plant and used as premises identification if they maintained until officially identified in contain a unique premises prefix that distinguishable groups identifiable to has been linked in the National Scrapie their flocks of origin and when re- Database with the assigned premises quired their flock of birth by means of identification number of the flock of partitions or other such maintenance; origin; and, (v) Premises identification eartags or (B) Accompanied by an owner state- tattoos, if the premises identification ment that contains the information method includes a unique animal num- needed to officially identify the ani- ber or is combined with a flock eartag mals to their flock of origin and, when that has a unique animal number and required, their flock of birth. If the the animal is accompanied by an owner slaughter plant has agreed to allow statement; APHIS to conduct slaughter sampling, (vi) Premises identification when animals need not be identified if they premises identification is allowed by arrive at the plant on days that an § 79.3 and the animal is accompanied by APHIS designated sampler is not avail- an owner statement; or able at the plant to collect samples; or (vii) Any other official identification (vi) Prior to moving a sheep or goat method or device approved by the Ad- across a State line, unless the animals ministrator.

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(3) The owner of the flock of origin is backtag, and tattoo numbers (series of responsible for the identification of alphanumeric USDA tags and backtags animals required to be identified by may be assigned as premises identifica- this section. No person who buys or tion if they are linked to the premises sells, for his or her own account or as in the National Scrapie Database) will the agent of the buyer or seller, trans- be assigned to animal owners by the ports, receives for transportation, of- State animal health official or the area fers for sale or transportation, or oth- veterinarian in charge, whoever is re- erwise handles sheep or goats in inter- sponsible for assigning premises codes state commerce shall receive or other- in that State. Persons assigned serial wise handle any animal in interstate numbers of United States Department commerce that has not been identified of Agriculture backtags, official sheep as required by this section. If an ani- and goat tattoos, official eartags, and mal loses its identification to its flock premises identification numbers must: of origin while in interstate commerce (1) If the person assigned the num- it is the responsibility of the person bers is a flock owner, so that the as- who has control or possession of the signed numbers are directly linked to animal to identify the animal prior to the flock of origin in the national commingling it with any other ani- scrapie database, record the following mals. This shall be done by applying information on a document: individual animal identification to the (i) The premises identification num- animal as required in paragraph (a)(2) ber or serial numbers; of this section and recording the means (ii) The number of animals so identi- of identification and the corresponding fied; animal identification number. If the (iii) The date the animals were iden- flock of origin cannot be determined, tified; all possible flocks of origin shall be (iv) For animals born after January listed on the record. 1, 2002, that were not born in the flock (b) Serial numbers for use in official of origin and that are not identified to identification will be assigned to each the previous flock of origin, the indi- person who applies to the State animal vidual identification number applied health official or the area veterinarian and the name, street address, including in charge for the State in which that the city and State, or the township, person maintains his or her place of county, and State, and the telephone business. Serial numbers of official number, if the telephone number is eartags will be assigned to each accred- available, of the flock of birth if ited veterinarian or State or APHIS known. representative who requests official (2) If the person assigned the num- eartags from the State animal health bers is a veterinarian, extension agent, official or the area veterinarian in auction market operator, dealer, or charge, whoever is responsible for any person other than the owner of the issuing official eartags in that State. flock of origin, record the following in- The official responsible for issuing formation on a document: eartags in a State may assign serial (i) All serial numbers applied to a numbers of official eartags to other re- sheep or goat; sponsible persons, such as 4–H leaders, (ii) Any other serial numbers and ap- if the State animal health official and proved identification appearing on the the area veterinarian in charge agree sheep or goat; that such assignments will improve (iii) The street address, including the scrapie control and eradication within city and State, or the township, coun- the State. Persons assigned serial num- ty, and State, of the premises where bers may either directly apply eartags the approved means of identification to animals, or may reassign eartag was applied; numbers to producers. If these persons (iv) The date the identification was reassign eartag numbers, they must applied; maintain appropriate records that per- (v) The name, street address, includ- mit traceback of animals to their flock ing the city and State, or the township, of origin, or flock of birth when re- county, and State, and the telephone quired. Premises identification eartag, number if the telephone number is

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available, of the owner of the flock of for use as premises identification. This origin and, if different, the person who does not preclude the owner of a flock owns or possesses the sheep or goat, from using a premises identification and number tag assigned to that flock on (vi) For animals born after January an animal owned by him that resides in 1, 2002, that were not born in the flock that flock but that was born or pre- of origin and that are not identified to viously resided on a different premises the previous flock of origin, the indi- as long as the records required in para- vidual identification number applied graph (b)(1)(iv) of this section are and the name, street address, including maintained. the city and State, or the township, (d) Each person who buys or sells, for county, and State, and the telephone his or her own account or as the agent number if the telephone number is of the buyer or seller, transports, re- available, of the flock of birth if ceives for transportation, offers for known. sale or transportation, or otherwise (vii) The serial numbers, the manu- handles sheep or goats in interstate facturer, and the type and color of all commerce must ensure that the ani- official tags received. Usually main- mals are identified as required in this taining the tag invoice will meet this part and must keep records relating to requirement. the transfer of ownership, shipment, or (3) Maintain these records for 5 years; handling of the sheep or goats, such as and yarding receipts, sale tickets, invoices, (4) Make these records available for and waybills. inspection and copying during ordinary (1) If official individual animal iden- business hours (8 a.m. to 5:30 p.m., tification is required, the records must Monday through Friday) upon request include the number of sheep and/or by any authorized employee of the goats; the breed or cross if known; the United States Department of Agri- name, street address, including city culture or the State, and presentation and State, or the township, county, and of his or her official credentials. State, and the telephone number if the (5) Any person who fails to comply telephone number is available, of the with these requirements shall not be owner of the flock of origin and, if dif- assigned serial numbers of United ferent, the person from whom the sheep States Department of Agriculture or goats were purchased or otherwise backtags, official sheep and goat tat- obtained; and a copy of any documents toos, official eartags, or premises iden- required to accompany the animal in- tification numbers. If a person who is cluding any certificate, owner state- not in compliance with these requirement, letter, or permit; and ments has already been assigned such (i) For animals not in slaughter serial numbers, the Administrator may channels the records must include all withdraw the assignment by giving no- serial numbers and other approved tice to such person. After such notice means of identification appearing on the person shall be subject to criminal the sheep or goat. This requirement and civil penalties if he continues to may usually be met by maintaining a use those assigned serial numbers. copy of the certificate that accom- (c) No person shall apply a premises panied the animals. The premises num- identification number or a brand or ber may be recorded instead of the in- earnotch pattern to an animal that did dividual numbers in the case of ani- not originate on the premises to which mals identified with premises identi- the number was assigned by a State or fication if: APHIS representative or to which the (A) The premises identification brand or earnotch pattern has been as- meets the requirements of paragraph signed by an official brand registry. (a)(2)(v) of this section for individual This includes individual identification animal identification; or such as USDA tags and backtags that (B) The animals are allowed to move have been assigned to a premises for interstate with only premises identi- use as premises identification and reg- fication in accordance with § 79.3. istration tattoos that contain prefixes (ii) For animals in slaughter chan- that have been assigned to a premises nels that are identified with individual

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animal identification traceable to the ment of Agriculture or the State, upon flock of origin or that are identified to that employee’s request and presen- the flock of origin with official prem- tation of his or her official credentials. ises identification that meets the re- (e) No person may remove or tamper quirements for individual animal iden- with any means of identification re- tification, no additional records are required to be on sheep or goats pursuant quired; to this section while the animals are in (iii) For animals in slaughter chan- interstate commerce, and, at the time nels that are identified with individual of slaughter, animal identification animal identification traceable to a must be maintained throughout post- previous flock but not to the flock of mortem inspection in accordance with origin, or that are identified with offi- regulations of the Food Safety and In- cial premises identification that meets spection Service, U.S. Department of the requirements for individual animal Agriculture, in chapter III of this title. identification that is traceable to a (f) Requirements for approval of official previous flock but not to the flock of premises and individual identification origin, the records must include all se- tags. (1) The Administrator may ap- rial numbers and other approved means prove tag companies to produce official of identification appearing on the premises and/or individual identifica- sheep or goat; tion tags for use on sheep or goats. (iv) For animals that are not re- Tags may be plastic or metal and must quired to be identified until they reach be an appropriate size for use in sheep their final destination, the records and goats. Tags must be able to legibly must include the final destination. accommodate the required alpha- (2) If official premises identification numeric sequences. Tags must resist is required or allowed, the records removal and be difficult to place on an- must include: other animal once removed, but need (i) The premises identification num- not be tamper-proof. Tags must be ber(s) and the number of animals iden- readily distinguishable as USDA offi- tified with each premises number; cial sheep and goat tags, must carry (ii) Copies of any required documents the alphanumeric sequences, symbols, such as the brand inspection certificate, an owner’s statement, an accred- or logos specified by APHIS, and must ited veterinarian’s statement, or a have a means of discouraging counter- health certificate; feiting, such as use of a unique (iii) The name, street address, includ- copywrited logo or trade mark. Tags ing city and State, or the township, for use only on animals in slaughter county, and State, and the telephone channels must be marked with the number if the telephone number is words ‘‘Meat’’ or ‘‘For Slaughter available, of the owner of the flock of Only,’’ or else must be used in conjunc- origin and, if different, the person from tion with an ear tattoo of the word whom the sheep or goats were pur- ‘‘Meat.’’ chased or otherwise obtained. (2) Written requests for approval of (3) Each person required to keep official premises identification tags for records under this paragraph must sheep and goats should be sent to the maintain the records for at least 5 Animal and Plant Health Inspection years after the person has sold or oth- Service, Veterinary Services, National erwise disposed of the sheep or goat to Animal Health Programs Staff, Atten- another person, and for such further tion: National Scrapie Program Coordi- period as the Administrator may re- nator, 4700 River Road Unit 43, River- quire by written notice to the person, dale, MD 20737–1235. The request must for purposes of any investigation or ac- include: tion involving the sheep or goat identi- (i) Data supporting the durability of fied in the records. The person must the tag and durability and legibility of make the records available for inspec- the identification numbers and high re- tion and copying during ordinary busi- tention rates of the tags in animals, ness hours (8 a.m. to 5:30 p.m., Monday preferably sheep and/or goats. Pref- through Friday) by any authorized em- erence will be given to tags with high ployee of the United States Depart- legibility and retention rates in sheep

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and goats that minimize injury to the proval may be withdrawn with 60 days ear. written notice. Any person who is ap- (ii) A signed statement agreeing to: proved to produce official premises or (A) Send official eartags only to a individual identification tags in ac- State or APHIS representative, to a cordance with this section and who flock owner at the address to which the knowingly produces tags that are not premises number or tag sequence was in compliance with the requirements of assigned by a State or APHIS rep- this section, and any person who is not resentative, or as directed by APHIS; approved to produce such tags but does (B) Provide a monthly report by so, shall be subject to such civil pen- State of all tags produced, including alties and such criminal liabilities as the tag sequences produced and the are provided by 18 U.S.C. 1001, 7 U.S.C. person’s and address to which the tags 8313, or other applicable Federal stat- were shipped; and utes. Such action may be in addition (C) When required by APHIS, enter to, or in lieu of, withdrawal of approval the sequences of tags shipped into the to produce tags. National Scrapie Database through a (g) New types of identification. Written web page interface or other means requests for approval of sheep or goat specified by APHIS. identification devices and markings (iii) Twenty-five sample tags. Addi- not listed in paragraph (a)(2) of this tional tags must be submitted if re- section should be sent to the Animal quested by APHIS. and Plant Health Inspection Service, (3) Approval to produce official prem- Veterinary Services, National Animal ises and/or individual identification Health Programs Staff, 4700 River Road tags will be valid for 1 year and must Unit 43, Riverdale, MD 20737–1235. If the be renewed annually. The Adminis- Administrator determines that the de- trator may also grant approval to vices and markings will provide a produce tags for periods of less than 1 means of tracing sheep and goats in year in cases where all of the submis- interstate commerce, a proposal will be sions required by this section have not published in the FEDERAL REGISTER to been received or evaluated but there is add the devices and markings to the substantial evidence that the tags list of approved means of sheep and meet the requirements of this section. goat identification. The Administrator may decline to renew a company’s approval if the tags [66 FR 43990, Aug. 21, 2001, as amended at 68 do not show adequate retention and du- FR 6343, Feb. 7, 2003; 69 FR 64650, Nov. 8, 2004] rability in field use or if any of the requirements of this section are not met § 79.3 General restrictions. by the tag company. If a company’s The following prohibitions and move- tags do not show adequate retention ment conditions apply to the interstate and durability in field use or if any of movement of sheep and goats, and no the requirements of this section are sheep or goat may move interstate ex- not met by the tag company, the ap- cept in compliance with them.

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INTERSTATE MOVEMENT GENERAL RESTRICTIONS FOR SHEEP AND GOATS Note: A CONSISTENT STATE is one whose intrastate identification, reporting, and movement restrictions for infected and source flocks and high-risk animals are consistent with the APHIS standards for State scrapie programs.

Type of interstate movement Moved from INCONSISTENT state Moved from CONSISTENT state

(a) Sale or other movement of breeding animals, show animals or any other animal not specifically addressed in this chart. General Condition: No animal may be removed from slaughter channels in interstate commerce if it was sold at a slaughter-only auction, is identified with a tag or ear tattoo marked ‘‘meat’’ or ‘‘slaughter only,’’ or was sold with a bill of sale marked for slaughter only, and other animals may be removed from slaughter channels in interstate commerce only if they are identified to their flock of birth.— (1) High-risk, scrapie-positive, or sus- Prohibited 1 ...... Prohibited 1 pect animals, or animals from a noncompliant flock. (2) Non-high-risk animals from an in- Prohibited 1 ...... Prohibited, 1 except as allowed in an ap- fected or source flock that are not proved scrapie control pilot project scrapie-positive or suspect animals. flock plan and must meet the requirements for exposed animals. (3) Sexually intact exposed animals Flock must be enrolled in the Complete Official individual animal identification that are not scrapie-positive, sus- Monitored category of the Scrapie and a permit. 2 For any female ex- pect, or high-risk animals and are Flock Certification Program or equiva- posed sheep the results of an official not animals from an infected or lent APHIS recognized program, have genotype test must be included on or source flock. official individual animal identification, attached to the permit and must be and a permit. 2 For any female ex- QR or RR at codon 171. For any fe- posed sheep the results of an official male animal moving for exhibition, the genotype test must be included on or permit must include a statement by attached to the permit and must be both the owner and an accredited vet- QR or RR at codon 171. For any fe- erinarian that the animal has not male animal moving for exhibition, the lambed or aborted within 30 days of permit must include a statement by being exhibited and is not due to lamb both the owner and the accredited vet- within 30 days of being exhibited and erinarian that the animal has not that there is no visible vaginal dis- lambed or aborted within 30 days of charge. For any animal born after 1– being exhibited and is not due to lamb 1–2002, the permit must include the within 30 days of being exhibited and flock of birth and the flock of origin, if that there is no visible vaginal dis- different. charge. For any animal born after 1– 1–2002, the certificate must include the flock of birth and the flock of origin, if different. (4)(i) Sexually intact sheep except as allowed in (a)(7). (ii) Sexually intact goats, except for Flock must be enrolled in the Complete Official individual animal identification low-risk goats. Monitored category of the Scrapie and a certificate. For any animal born Flock Certification Program or equiva- after 1–1–2002, the certificate must in- lent APHIS-recognized program, have clude the flock of birth and the flock of official individual animal identification, origin, if different. and a certificate. For any animal born after 1–1–2002, the certificate must include the flock of birth and the flock of origin, if different. (5) Sexually intact low-risk goats ...... Official individual animal identification Official individual animal identification and a certificate. For any animal born and a certificate. For any animal born after 1–1–2002, the certificate must in- after 1–1–2002, the certificate must include the flock of birth and the flock of clude the flock of birth and the flock of origin, if different. origin, if different. (6) Castrated animals that are not Official individual animal identification None, except for exposed animals that scrapie-positive or suspect animals. and a certificate. must have official individual animal identification.

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INTERSTATE MOVEMENT GENERAL RESTRICTIONS FOR SHEEP AND GOATS—Continued Note: A CONSISTENT STATE is one whose intrastate identification, reporting, and movement restrictions for infected and source flocks and high-risk animals are consistent with the APHIS standards for State scrapie programs.

Type of interstate movement Moved from INCONSISTENT state Moved from CONSISTENT state

(7) Low-risk commercial sheep ...... Official individual animal identification (i) Official premises identification that is and a certificate, and the flock must a permanent brand or ear notch pat- be enrolled in the Complete Monitored tern registered with an official brand category of the Scrapie Flock Certifi- registry; cation Program or an equivalent (ii) A brand inspection certificate; APHIS-recognized program. For any (iii) An owner statement dated within 30 animal born after 1–1–2002, the certifi- days stating that the animals were cate must include the flock of birth and born in the flock, that the flock does the flock of origin, if different. not contain any animal exhibiting signs of scrapie, that to the best of his or her knowledge the flock has no risk factors for or exposure to scrapie, and that the flock has never contained: (A) Any animal diagnosed as having scrapie; (B) any female blackfaced sheep; or (C) any female blackfaced cross sheep that were not born in the flock; and (iv) An accredited veterinarian’s statement issued within 12 months of the date of movement indicating that, to the best of his or her knowledge, the flock has no known risk factors for or exposure to scrapie, and that he or she has inspected the flock and it does not contain: (A) Any animal exhibiting signs of scrapie; (B) any female blackfaced sheep; or (C) any female blackfaced cross sheep that were not born in the flock. The statements must include the owner’s name, address, and the premises identification number and a drawing of the owner’s registered brand or ear notch pattern. (8) Commercial low-risk goats...... Official individual animal identification None. and a certificate. For any animal born after 1–1–2002, the certificate must include the flock of birth and the flock of origin, if different. (b) Sale or other movement directly to slaughter, through slaughter channels to slaughter, or to feedlots for later movement to slaughter of animals that are under 18 months of age as evidenced by eruption of the second incisor, not pregnant, and have not lambed or kidded. General Condition: No animal may be removed from slaughter channels in interstate slaughter channels in interstate commerce if it was sold at a slaughter-only auction, is identified with a tag or ear tattoo marked ‘‘meat’’ or ‘‘slaughter only,’’ or was sold with a bill of sale marked for slaughter only, and other animals may be removed from slaughter channels in interstate commerce only if they are identified to their flock of birth.— (1) Scrapie-positive or suspect ani- Prohibited 1 ...... Prohibited. 1 mal. (2) Sexually intact high-risk animals Official individual animal identification Official individual animal identification and sexually intact animals from in- and a permit, or a permit and an indel- and a permit, or a permit and an indel- fected or source flocks that are not ible ‘‘S’’ mark on the left jaw, or sealed ible ‘‘S’’ mark on the left jaw, or sealed scrapie-positive or suspect animals. conveyance and a permit. (Note: these conveyance and a permit. (Note: these animals may only be permitted to animals may only be permitted to slaughter or to terminal feedlots. 3) slaughter or to terminal feedlots. 3)

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Type of interstate movement Moved from INCONSISTENT state Moved from CONSISTENT state

(3) Exposed sexually intact animals Official individual animal identification for Official individual animal identification for that are not scrapie-positive, sus- any animal that is not moving directly any animal that is not moving direct to pect, or high-risk. animals and that to slaughter or to a terminal feedlot. 3,4 slaughter or to a terminal feedlot. 3,4 are not animals from an infected or (Note: pregnant animals and animals (Note: Pregnant animals and animals source flock. with a visible vaginal discharge may with a visible vaginal discharge may only be permitted to slaughter or to only be permitted to slaughter or to terminal feedlots.). terminal feedlots.) (4) Sexually intact sheep that are not Official premises identification or official None. scrapie-positive, suspect, high-risk, individual animal identification for any or exposed animals and are not animal that is not moving direct to animals from an infected or source slaughter or to a terminal feedlot. 3 flock. (5) Sheep enrolled in the selective None ...... None. monitored or complete monitored category of the SFCP that are not scrapie-positive, suspect, high-risk, or exposed animals. (6) Castrated animals that are not None ...... None. scrapie-positive, or suspect animals. (7) Sexually intact goats that are not None ...... None. scrapie-positive, suspect, high-risk, or exposed animals and are not animals from an infected or source flock. (c) Sale or other movement directly to slaughter, through slaughter channels to slaughter, or to feedlots for later movement to slaughter of animals that are over 18 months of age, as evidenced by eruption of the second incisor, or that are pregnant or that have lambed or kidded. General Condition: No animal may be removed from slaughter channels in interstate commerce if it was sold at a slaughter-only auction, is identified with a tag or ear tattoo marked ‘‘meat’’ or ‘‘slaughter only,’’ or was sold with a bill of sale marked for slaughter only, and other animals may be removed from slaughter channels in interstate commerce only if they are identified to their flock of birth.— (1) Scrapie-positive or suspect ani- Prohibited 1 ...... Prohibited. 1 mal. (2) Sexually intact high-risk animals Official individual animal identification Official individual animal identification and sexually intact animals from and a permit, or a permit and an indel- and a permit, or a permit and an indel- an infected or source flock that are ible ‘‘S’’ mark on the left jaw, or sealed ible ‘‘S’’ mark on the left jaw, or sealed not scrapie-positive, or suspect conveyance and a permit. (Note: these conveyance and a permit. (Note: animals. animals may only be permitted to These animals may only be permitted slaughter or to terminal feedlots. 3 to slaughter or to terminal feedlots. 3 (3) Sexually intact exposed animals Official individual animal identification Official individual animal identification. that are not scrapie-positive, sus- and a permit, or a permit and an indel- (Note: pregnant animals and animals pect, or high-risk animals and are ible ‘‘S’’ mark on the left jaw, or sealed with a visible vaginal discharge may not animals from an infected or conveyance and a permit when mov- only be moved directly to slaughter or source flock. ing directly to slaughter. (Note: preg- to terminal feedlots.3,4 nant animals and animals with a visible vaginal discharge may only be permitted to slaughter or to terminal feedlots. 3,4 (4) Sheep over 18 months of age Official individual animal identification Official individual animal identification. 4 that are not scrapie-positive, sus- and a certificate. 4. pect, sexually intact high-risk, or sexually intact exposed animals and that are not sexually intact animals from an infected or source flock.

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Type of interstate movement Moved from INCONSISTENT state Moved from CONSISTENT state

(5) Low-risk commercial sheep ...... Official individual animal identification (i) Official premises identification that is and a certificate 4. a permanent legible brand or ear notch pattern registered with an official brand registry or, in the case of animals moving directly to slaughter, may be a legible paint brand registered with an official brand registry; (ii) A brand inspection certificate; (iii) An owner statement dated within 30 days of the movement stating that the flock does not contain any animal exhibiting signs of scrapie, and that, to the best of his or her knowledge, the flock has no risk factors for or exposure to scrapie and has never contained: (A) Any animal diagnosed as having scrapie; (B) any female blackfaced sheep; or (C) any female blackfaced cross sheep that was not born in the flock; (iv) An accredited veterinarian’s statement issued within 12 months of the date of movement indicating that, to the best of his or her knowledge, the flock has no known risk factors for or exposure to scrapie, and that he or she has inspected the flock and it does not contain: (A) Any animal exhibiting signs of scrapie; (B) any female blackfaced sheep; or (C) any female blackfaced cross sheep that was not born in the flock. The statements must include the owner’s name, address, and the premises identification number and a drawing of the owner’s registered brand or ear notch pattern. 4 (6) Goats that are not scrapie-posi- None ...... None. tive, suspect, sexually intact high- risk, or sexually intact exposed animals and that are not sexually intact animals from an infected or source flock. (d) Movement of animals for grazing or other management purposes without change of ownership.— (1) Scrapie-positive, suspect, or sex- Prohibited 1 ...... Prohibited. 1 ually intact high-risk animals. (2) Non-high-risk animals from an in- Prohibited 1 ...... Prohibited, 1 except as allowed in an ap- fected or source flock. proved scrapie control pilot project flock plan and must meet the requirements for exposed animals. (3) Sexually intact exposed animals Official individual animal identification Official individual animal identification that are not scrapie-positive, sus- and a permit. 2 For any female ex- and a permit. 2 For any female ex- pect, or high-risk animals and that posed sheep the results of an official posed sheep the results of an official are not animals from an infected or genotype test must be included on or genotype test must be included on or source flock. attached to the permit and must be attached to the permit and must be QR or RR at codon 171. QR or RR at codon 171. (4) Sexually intact sheep or sexually Official premises identification and a cer- None. intact goats that have been com- tificate.. mingled with sheep and that are not scrapie-positive, suspect, high- risk, or exposed animals and are not animals from an infected or source flock.

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Type of interstate movement Moved from INCONSISTENT state Moved from CONSISTENT state

(5) Sexually intact goats that have None ...... None. not been commingled with sheep and that are not scrapie-positive, suspect, high-risk, or exposed animals and are not animals from an infected or source flock. (6) Castrated animals that are not None ...... None. scrapie-positive or suspect animals and are not an animal from an infected or source flock. 1 Animals prohibited movement may be moved interstate only if they are moving interstate for destruction or research as approved by the Administrator. 2 A copy of the permit must be sent to the State veterinarian and the AVIC of the receiving State prior to movement of animals. 3 No exposed or high-risk animal from any State or any animal from an Inconsistent State shall be removed from slaughter channels once it has entered interstate commerce. 4 Official individual animal identification or official premises identification is not required for these slaughter animals if the animals are kept as a group on the same premises on which they were born or used for breeding purposes and are not commingled with animals from another premises at any time, including throughout the feeding, marketing, and slaughter process.

§ 79.4 Designation of scrapie-positive mals. Flocks meeting the definition of animals, high-risk animals, exposed infected or source flocks that are des- animals, suspect animals, exposed ignated as exposed flocks must com- flocks, infected flocks, noncompli- plete a post exposure monitoring and ant flocks, and source flocks; notice to owners. management plan. Testing may include live-animal testing using a live-animal (a) Designation. A designated scrapie official test, an official genotype test, epidemiologist will designate an ani- the culling and postmortem examina- mal to be a scrapie-positive animal, high-risk animal, exposed animal, or tion and testing of genetically suscep- suspect animal after determining that tible animals in the flock that cannot the animal meets the criteria of the be evaluated by a live animal test, and relevant definition in § 79.1. postmortem examination and testing (1) A State or APHIS veterinarian of animals found dead or cull animals will designate an animal to be a sus- at slaughter. pect animal after determining that the (ii) If an owner does not make his or animal meets the criteria of the rel- her animals available for testing with- evant definition in § 79.1. in 60 days of notification or as mutu- (2) A designated scrapie epidemiolo- ally agreed or fails to submit required gist will designate a flock to be a postmortem samples, the flock will be source, infected, or exposed flock after designated a source, infected, or ex- reviewing sale, movement, and breed- posed flock, whichever definition ap- ing records that indicate the flock plies. Any flock that is pending des- meets the criteria of the relevant defi- ignation must comply with the move- nition in § 79.1. ment restrictions for infected flocks. (i) A designated scrapie epidemiologist may conduct testing of animals if (3) A designated scrapie epidemiolo- he or she determines such testing is gist will designate a flock to be a non- needed to properly designate a flock to compliant flock after determining that be a source, infected, or exposed flock. the flock meets the definition of a non- The designated scrapie epidemiologist compliant flock in § 79.1. will select animals for testing in a (b) Redesignation. (1) A designated manner that will provide a 95 percent scrapie epidemiologist may reclassify confidence of detecting scrapie at a an animal designated a high-risk ani- prevalence of 1 percent or, when flock mal as an exposed animal after receiv- records are adequate and all exposed ing negative results from an official animals that lambed in the flock are test or in accordance with an approved available for testing, may limit the Scrapie Control Pilot Project. testing to all exposed and suspect ani-

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(2) A State or APHIS veterinarian animals found dead or cull animals at may remove the suspect animal des- slaughter. A designated scrapie epi- ignation from an animal that had clin- demiologist shall redesignate an ex- ical signs of scrapie and that did not posed flock as a noncompliant flock if test positive for scrapie or for the pro- the owner fails to make his animals teinase resistant protein associated available for testing within 60 days of with scrapie upon determination that notification or as mutually agreed or it is alive and no longer exhibits such fails to submit required postmortem signs, or that the signs are not caused samples. by scrapie. (6) Based on an epidemiologic inves- (3) A designated scrapie epidemiolo- tigation and testing, a designated gist may remove the suspect animal scrapie epidemiologist may redesignate designation from an animal that has an infected flock or source flock as an tested positive for scrapie or for the exposed flock. The designated scrapie proteinase resistant protein associated epidemiologist may only use this op- with scrapie on an unofficial test based tion when the epidemiologic investiga- on knowledge of the test used or based tion reveals that the scrapie exposure on an epidemiologic investigation was minor or could not be confirmed which may include additional testing due to inadequate records. The des- of the suspect animal and or animals ignated scrapie epidemiologist will se- that have been commingled with the lect animals for testing in a manner suspect animal. that will provide a 95 percent con- (4) A designated scrapie epidemiolo- fidence of detecting scrapie at a preva- gist may remove the suspect animal lence of 1 percent or, when flock designation from an animal that tested records are adequate and all exposed positive on a live-animal screening test animals that lambed in the flock are based on an epidemiologic investiga- available for testing, may limit the tion which includes additional official testing to all exposed and suspect ani- testing of the suspect animal and when mals. Testing may include live-animal appropriate, animals that have been testing using a live-animal official commingled with the suspect animal. test, an official genotype test, the cull- (5) A designated scrapie epidemiologist may remove the exposed flock des- ing and postmortem examination and ignation after completing an epidemio- testing of genetically susceptible ani- logic investigation or upon completion mals in the flock that cannot be evalu- of a post-exposure management and ated by a live animal test, and post- monitoring plan. As part of the epi- mortem examination and testing of demiologic investigation the des- animals found dead or cull animals at ignated scrapie epidemiologist may slaughter. Infected or source flocks conduct testing of animals if he or she that are redesignated as exposed flocks determines such testing is needed to must complete a post exposure moni- properly redesignate the flock. The toring and management plan. If an designated scrapie epidemiologist will owner does not make his or her ani- select animals for testing in a manner mals available for testing within 60 that will provide a 95 percent con- days of notification or as mutually fidence of detecting scrapie at a preva- agreed or fails to submit required post- lence of 1 percent or, when flock mortem samples, the flock designation records are adequate and all exposed will remain unchanged. animals that lambed in the flock are (7) A designated scrapie epidemiolo- available for testing, may limit the gist may remove the noncompliant testing to all exposed and suspect ani- flock designation after reviewing any mals. Testing may include live-animal required testing of the flock and deter- testing using a live-animal official mining that the flock has complied test, an official genotype test, the cull- with the required testing or no longer ing and postmortem examination and meets the definition of a noncompliant testing of genetically susceptible ani- flock. mals in the flock that cannot be evalu- (8) A designated scrapie epidemiolo- ated by a live animal test, and post- gist may redesignate an exposed ani- mortem examination and testing of mal, exposed flock, or infected flock by

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removing that designation after com- premises identification 4 that is as- pleting an epidemiologic investigation signed to the flock of origin and that and determining that the exposure was meets the requirements for individual limited to a scrapie-positive male ani- animal identification, the premises mal that was not born in the flock (the number may be recorded instead of the owner must have adequate records and individual identification numbers. A animal identification to show that the certificate must also show the number scrapie-positive male animal was pur- of animals covered by the certificate; chased). the purpose for which the animals are (c) Notice to owner. As soon as pos- to be moved; the points of origin and sible after making such a determina- destination; the consignor, and the tion, a State or APHIS representative consignee. Certificates must indicate the flock of birth for any breeding will attempt to notify the owner(s) of sheep born after January 1, 2002, that the flock(s) in writing that their flock are covered by the certificate. The cer- contained or contains a scrapie-posi- tificate must include a statement by tive animal, a suspect animal, a high- the issuing accredited or State or Fed- risk animal or an exposed animal, or eral veterinarian that the animals were that the flock is an infected, source, not exhibiting clinical signs associated exposed, or noncompliant flock or that with scrapie at the time of examina- the flock is pending designation as an tion and an owner statement indi- infected, source, exposed, or non- cating whether the animal is or is not compliant flock. The notice will in- a scrapie-positive, suspect, high-risk or clude: exposed animal and whether it origi- (1) A description of the interstate nated in an infected, source, exposed, movement restrictions and identifica- or noncompliant flock. Except as pro- tion requirements; vided in paragraphs (b) and (c) of this (2) Reporting requirements; section, all of the information required (3) Sample submission requirements by this paragraph must be typed or for suspect and high-risk animals con- written on the certificate. Note that in tained in this part; accordance with § 79.3(a), (b), and (c), (4) Options for controlling the spread scrapie-positive, suspect, and high-risk of scrapie from, and eradicating scrapie animals, some exposed animals, and in, an infected flock or source flock or animals that originated in an infected to reduce the risk of the occurrence of or source flock require permits rather scrapie in a flock that contains a high- than certificates. risk or an exposed animal; and (b) Animal identification documents attached to certificates. As an alternative (5) In the case of flocks that are to typing or writing individual animal pending designation the notification identification on a certificate, another shall include the testing options avail- document may be used to provide this able to them and the designation their information, but only under the fol- flock will receive if they decline to lowing conditions: test. (1) The document must be a State form or APHIS form that requires indi- § 79.5 Issuance of certificates. vidual identification of animals; (a) Certificates are required as speci- (2) A legible copy of the document fied by § 79.3 for certain interstate must be stapled to the original and movements of animals. A certificate each copy of the certificate; must show the official ear tag number, (3) Each copy of the document must individual animal registered breed as- identify each animal to be moved with sociation registration tattoo, individual animal registered breed associa- 4 Ownership brands may be used on certifi- tion registration brand, individual ani- cates for sheep and goats moved interstate mal registered breed association reg- when premises identification is required istration number, and any other offi- under this part, provided the ownership cial individual identification of each brands are legible and are registered with the official brand recording agency and the animal to be moved; provided that, in animals are accompanied by a brand inspec- the case of animals identified with tion certificate.

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the certificate, but any information will evaluate the State statutes, regu- pertaining to other animals, and any lations, and directives pertaining to unused space on the document for re- animal health activities; reports and cording animal identification, must be publications of the State animal health crossed out in ink; and agency; and a written statement from (4) The following information must the State animal health agency de- be typed or written in ink in the iden- scribing State scrapie control activi- tification column on the original and ties and certifying that these activities each copy of the certificate and must meet the requirements of this section. be circled or boxed, also in ink, so that In determining whether a State is a no additional information can be Consistent State, the Administrator added: will determine whether the State: (i) The name of the document; and (1) Has the authority, based on State (ii) Either the serial number on the law or regulation, to restrict the move- document or, if the document is not ment of all scrapie-infected and source imprinted with a serial number, both the name of the person who prepared flocks. the document and the date the docu- (2) Has the authority, based on State ment was signed. law or regulation, to require the re- (c) Ownership brands documents at- porting of any animal suspected of hav- tached to certificates. As an alternative ing scrapie and test results for any ani- to typing or writing ownership brands mals tested for scrapie to State or Fed- on a certificate, an official brand in- eral animal health authorities. spection certificate may be used to (3) Has, in cooperation with APHIS provide this information, but only personnel, drafted and signed a memo- under the following conditions: randum of understanding between (1) A legible copy of the official brand APHIS and the State that delineates inspection certificate must be stapled the respective roles of each in the Na- to the original and each copy of the tional Scrapie Program implementa- certificate; tion. (2) Each copy of the official brand in- (4) Has placed all known scrapie-inspection certificate must show the fected and source flocks under move- ownership brand of each animal to be ment restrictions, with movement of moved with the certificate, but any animals only to slaughter, to feedlots other ownership brands, and any un- under permit and movement restric- used space for recording ownership tions that ensure later movement to brands, must be crossed out in ink; and slaughter, for destruction, or for re- (3) The following information must search. Scrapie-positive and suspect be typed or written in ink in the offi- animals may be moved only for trans- cial identification column on the origi- port to an approved research facility or nal and each copy of the certificate and for purposes of destruction. must be circled or boxed, also in ink, so (5) Has effectively implemented poli- that no additional information can be cies to: added: (i) The name of the attached docu- (i) Investigate all animals reported ment; and as scrapie suspect animals within 7 (ii) Either the serial number on the days of notification; official brand inspection certificate or, (ii) Designate a flock’s status, within if the official brand inspection certifi- 15 days of notification that the flock cate is not imprinted with a serial contains a scrapie-positive animal, number, both the name of the person based on an investigation by State or who prepared the official brand inspec- Federal animal health authorities and tion certificate and the date it was in accordance with this part; signed. (iii) Restrict the movement, in accordance with paragraph (a)(4) of this § 79.6 Standards for States to qualify section, of newly designated scrapie-in- as Consistent States. fected and source flocks within 7 days (a) In reviewing a State for Con- after they are designated in accordance sistent State status, the Administrator with § 79.4;

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(iv) Relieve infected and source flock that the animal may be traced to its movement restrictions only after com- flock of birth; provided that: pletion of a flock plan created in ac- (A) A State may exempt commercial cordance with § 54.14 of this chapter or goats in intrastate commerce that a flock plan created in accordance with have not been in contact with sheep an approved scrapie control pilot from this identification requirement if project, or as permitted by the condi- there has been in that State no case of tions of such a flock plan, and after scrapie in a commercial goat in the agreement by the owner to comply past 10 years that originated in that with a 5-year post-exposure manage- State and cannot be attributed to expo- ment and monitoring plan; sure to infected sheep, and there are no (v) Conduct an epidemiologic inves- exposed commercial goat herds in that tigation of source and infected flocks State; and that includes the designation of high- (B) A State may exempt commercial risk and exposed animals and that whitefaced sheep or commercial hair identifies animals to be traced; sheep under 18 months of age in intra- (vi) Conduct tracebacks of scrapie- state commerce from this identifica- positive animals and traceouts of high- risk and exposed animals and report tion requirement if there has been in any out-of-State traces to the appro- that State no case of scrapie in the ex- priate State within 45 days of receipt of empted class that originated from that notification of a scrapie-positive ani- State, and there are no exposed com- mal; and mercial whitefaced or hair sheep flocks (vii) Conduct tracebacks based on in that State that have been exposed slaughter sampling within 15 days of by a female animal. receipt of notification of a scrapie-posi- (C) States that exempt these types of tive animal at slaughter. commercial animals must put in place (6) Effectively monitors and enforces the regulations necessary to require quarantines. identification of these animals within (7) Effectively enforces State report- 90 days of these conditions no longer ing laws and regulations for scrapie. existing. (8) Has designated at least one (ii) Maintains in the National APHIS or State animal health official Scrapie Database administered by to coordinate scrapie program activi- APHIS, or in a State database ap- ties in the State and to serve as the proved by the Administrator as com- designated scrapie epidemiologist in patible with the National Scrapie the State. Database, the State’s: (9) Has educated those engaged in the (A) Premises information and as- interstate movement of sheep and signed premises numbers and indi- goats regarding the identification and vidual identification number sequences recordkeeping requirements of this assigned for use as premises identifica- part. tion; (10) Has provided APHIS with a plan (B) Individual animal information on and timeline for complying with the all scrapie-positive, suspect, high-risk, following additional requirements, and exposed animals in the State; which must be met within 2 years of (C) Individual animal information on designation of the State as a Con- 5 all out-of-State animals to be traced; sistent State : and (i) Requires, based on State law or (D) Accurate flock status data. regulation, and effectively enforces official identification upon change of (iii) Requires official individual iden- ownership of all animals of any age not tification of any live scrapie-positive, in slaughter channels and any sheep suspect, or high-risk animal of any age over 18 months of age as evidenced by and of any sexually intact exposed ani- eruption of the second incisor such mal of more than 1 year of age or any sexually intact exposed animal of less 5 This provision would apply until January than 1 year of age upon change of own- 1, 2003. Any State designated as a Consistent ership (except for exposed animals State after that date would have to meet all moving in slaughter channels at less requirements prior to designation. than 1 year of age), whether or not the

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animal resides in a source or infected (b) [Reserved] flock. (iv) Effectively enforces movement PART 80—JOHNE’S DISEASE IN restrictions on all scrapie-positive, sus- DOMESTIC ANIMALS pect, and high-risk animals throughout their lives unless they are moved in ac- Sec. cordance with § 79.3. 80.1 Definitions. (v) Requires that tissues from all 80.2 General restrictions. scrapie-positive or suspect animals and 80.3 Movement of domestic animals that are female high-risk animals that have positive to an official Johne’s disease lambed (when they have died or have test. been destroyed) be submitted to a lab- 80.4 Segregation of animals positive to an oratory authorized by the Adminis- official Johne’s disease test during interstate movement. trator to conduct scrapie tests and requires complete destruction of the car- AUTHORITY: 7 U.S.C. 8301–8317; 7 CFR 2.22, casses of scrapie-positive and suspect 2.80, and 371.4. animals. SOURCE: 65 FR 18878, Apr. 10, 2000, unless (vi) Prohibits any animal from being otherwise noted. removed from slaughter channels unless it is identified to the flock of § 80.1 Definitions. birth, is not from an Inconsistent The following definitions apply to State, and is not scrapie-exposed or this part: from an infected or source flock. Administrator. The Administrator, (b) If the Administrator determines Animal and Plant Health Inspection that statutory changes are needed to Service, or any person authorized to bring a State into full compliance, the act for the Administrator. Administrator may grant up to a 2- Animal identification number (AIN). A year extension to allow a State to ac- numbering system for the official iden- quire additional authorities before re- tification of individual animals in the moving a State’s Consistent Status. United States providing a nationally The decision to grant an extension will unique identification number for each be based on the State’s ability to pre- animal. The AIN contains 15 digits, vent the movement of scrapie-infected with the first 3 being the country code animals out of the State and on the (840 for the United States), the alpha progress being made in making the characters USA, or the numeric code needed statutory changes. assigned to the manufacturer of the identification device by the Inter- § 79.7 Waiver of requirements for national Committee on Animal Record- scrapie control pilot projects. ing. The AIN beginning with the 840 (a) The Administrator may waive the prefix may be used only on animals following requirements of this part for born in the United States. participants in a scrapie control pilot APHIS. The Animal and Plant Health project by recording the requirements Inspection Service of the United States waived in the scrapie control pilot Department of Agriculture. project plan: APHIS representative. An individual (1) The determination that an animal employed by APHIS who is authorized is a high-risk animal, if the scrapie to perform the function involved. control pilot project plan contains Approved livestock facility. A stock- testing or other procedures that indi- yard, livestock market, buying station, cate that an animal, despite meeting concentration point, or any other the definition of high-risk animal, is premises that has been approved under unlikely to spread scrapie; and § 71.20 of this chapter. (2) The requirement that high-risk Area veterinarian in charge. An APHIS animals must be removed from a flock, veterinarian authorized by the Admin- if the scrapie control pilot project plan istrator to supervise and manage the contains alternative procedures to pre- animal health work of APHIS in a vent the further spread of scrapie with- specified area of the United States. out removing high-risk animals from Interstate. From one State into or the flock. through any other State.

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Johne’s disease. An infectious and Owner-shipper statement. A statement communicable disease that primarily signed by the owner or shipper of ani- affects cattle, sheep, goats, and other mals, which states: The number of ani- domestic, exotic, and wild ruminants, mals to be moved, the official eartag also known as paratuberculosis, caused number of each animal, the species of by Mycobacterium paratuberculosis. the animals, points of origin and des- Moved. Shipped, transported, deliv- tination, the consignor and consignee, ered, or received for movement, or oth- a statement that the animals are posi- erwise aided, induced, or caused to be tive to an official Johne’s disease test, moved. and any additional information re- Official eartag. An identification tag quired by this part. providing unique identification for in- Premises identification number (PIN). A dividual animals. An official eartag nationally unique number assigned by which contains or displays an AIN with a State, Tribal, and/or Federal animal an 840 prefix must bear the U.S. shield. health authority to a premises that is, The design, size, shape, color, and in the judgment of the State, Tribal, other characteristics of the official and/or Federal animal health author- eartag will depend on the needs of the ity, a geographically distinct location users, subject to the approval of the from other premises. The premises Administrator. The official eartag identification number is associated must be tamper-resistant and have a with an address, geospatial coordi- high retention rate in the animal. Offi- cial eartags must adhere to one of the nates, and/or other location descriptors following numbering systems: which provide a verifiably unique loca- (1) National Uniform Eartagging Sys- tion. The premises identification num- tem. ber may be used in conjunction with a (2) Animal identification number producer’s own livestock production (AIN). numbering system to provide a unique (3) Premises-based number system. identification number for an animal. The premises-based number system The premises identification number combines an official premises identi- may consist of: fication number (PIN), as defined in (1) The State’s two-letter postal ab- this section, with a producer’s live- breviation followed by the premises’ stock production numbering system to assigned number; or provide a unique identification num- (2) A seven-character alphanumeric ber. The PIN and the production num- code, with the right-most character ber must both appear on the official being a check digit. The check digit tag. number is based upon the ISO 7064 Mod (4) Any other numbering system ap- 36/37 check digit algorithm. proved by the Administrator for the Recognized slaughtering establishment. identification of animals in commerce. A slaughtering establishment 2 oper- Official Johne’s disease test. An orga- ating under the Federal Meat Inspec- nism detection test approved by the tion Act (21 U.S.C. 601 et seq.) or a State Administrator and conducted in a lab- inspected slaughtering establishment. oratory approved by the Adminis- State. Any of the 50 States, the Com- trator. 1 monwealth of Puerto Rico, the Com- monwealth of the Northern Mariana Is- 1 A list of currently approved laboratories lands, the District of Columbia, and and the requirements for obtaining approval any territories and possessions of the are available from the Diagnostic Bacteri- ology Laboratory, National Veterinary Serv- United States. ices Laboratories, P.O. Box 844, Ames, Iowa State animal health official. The State 50010. the Administrator will approve labora- official responsible for livestock and tories to conduct an official Johne’s disease poultry disease control and eradication test only after determining that the labora- programs. tory meets the check test proficiency requirements prescribed by the National Vet- erinary Services Laboratories. Approval will 2 A list of recognized slaughtering estab- continue as long as such check test pro- lishments in any State may be obtained from ficiency requirements are met on an annual an APHIS representative, the State animal basis. health official, or a State representative.

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State representative. An individual em- cleaned and disinfected in accordance ployed in animal health work by a with § 71.7 of this chapter. State or political subdivision of a State, and who is authorized by the § 80.4 Segregation of animals positive State or political subdivision to per- to an official Johne’s disease test during interstate movement. form tasks required by this part. United States. All of the States. Animals that are positive to an official Johne’s disease test may not be [65 FR 18878, Apr. 10, 2000, as amended at 69 moved interstate in a railroad car, FR 64650, Nov. 8, 2004; 72 FR 39306, July 18, 2007; 73 FR 54062, Sept. 18, 2008] boat, truck, or other vehicle containing healthy animals susceptible to § 80.2 General restrictions. Johne’s disease unless all of the animals are for immediate slaughter, or Domestic animals that are positive unless the positive animals are kept to an official Johne’s disease test may separate from the other animals by a not be moved interstate except in com- partition that is securely affixed to the pliance with this part. sides of the vehicle and prevents the § 80.3 Movement of domestic animals transfer of fecal matter from the ani- that are positive to an official mals positive to an official Johne’s dis- Johne’s disease test. ease test to the healthy animals in the (a) Movement of domestic animals for vehicle. slaughter. Domestic animals that are positive to an official Johne’s disease PART 81—CHRONIC WASTING test may be moved interstate for DISEASE IN DEER, ELK, AND MOOSE slaughter if: (1) The animals are moved directly to Sec. a recognized slaughtering establish- 81.1 Definitions. ment or to an approved livestock facil- 81.2 Identification of deer, elk, and moose in interstate commerce. ity for sale to a recognized slaugh- 81.3 General restrictions. tering establishment; 81.4 Issuance of certificates. (2) An owner-shipper statement that 81.5 Movement of deer, elk, or moose identifies the animals as positive to an through a State to another State. official Johne’s disease test accom- 81.6 Federal preemption of State and local panies the animals during the move- laws and regulations with respect to ment and is delivered to the consignee; CWD. (3) Each animal bears an official AUTHORITY: 7 U.S.C. 8301–8317; 7 CFR 2.22, eartag; and 2.80, and 371.4. (4) The animals are moved to the des- SOURCE: 77 FR 35569, June 13, 2012, unless tination in one continuous movement otherwise noted. without unloading. (b) Other movements. The Adminis- § 81.1 Definitions. trator may, upon request in specific These definitions are applicable to cases, allow domestic animals that are this part: positive to an official Johne’s disease Accredited veterinarian. A veteri- test to be moved interstate other than narian approved by the Administrator as provided in paragraph (a) of this sec- in accordance with part 161 of this tion, under such conditions as the Ad- chapter to perform functions specified ministrator may prescribe in each case in subchapters B, C, and D of this chap- to prevent the spread of Johne’s dis- ter. ease. The Administrator will promptly Administrator. The Administrator, notify the State animal health officials Animal and Plant Health Inspection of the States involved of any such ac- Service, or any person authorized to tion. act for the Administrator. (c) Cleaning and disinfecting. Each Animal. Any farmed or captive deer, means of conveyance used to transport elk, or moose. the animals must be cleaned and dis- Animal and Plant Health Inspection infected in accordance with § 71.6 of Service (APHIS). The Animal and Plant this chapter. The facilities in which Health Inspection Service of the United the animals were maintained must be States Department of Agriculture.

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Animal identification. A device or Eartagging System employs an eight- means of animal identification ap- or nine-character alphanumeric for- proved for use under this part by mat, consisting of a two-number State APHIS. Examples of animal identifica- or territory code, followed by two or tion devices that APHIS has approved three letters and four additional num- are listed in § 55.25 of this chapter. bers. Official APHIS disease control Animal identification number (AIN). A programs may specify which format to numbering system for the official iden- employ. tification of individual animals in the Official animal identification. A device United States. The AIN contains 15 dig- or means of animal identification ap- its, with the first 3 being the country proved for use under this part by code (840 for the United States), the APHIS to uniquely identify individual alpha characters USA, or the numeric animals. Examples of approved official code assigned to the manufacturer of animal identification devices are listed the identification device by the Inter- in § 55.25 of this chapter. The official national Committee on Animal Record- animal identification must include a ing. nationally unique animal identifica- APHIS employee. Any individual em- tion number that adheres to one of the ployed by the Animal and Plant Health following numbering systems: Inspection Service who is authorized (1) National Uniform Eartagging Sys- by the Administrator to do any work tem. The CWD program allows the use or perform any duty in connection with of either the eight-character or nine- the control and eradication of disease. character format for cervids. Cervid. All members of the family (2) Animal identification number Cervidae and hybrids, including deer, (AIN). elk, moose, caribou, reindeer, and re- (3) Premises-based number system. lated species. For the purposes of this The premises-based number system part, the term ‘‘cervid’’ refers specifi- combines an official premises identi- cally to cervids susceptible to CWD. fication number (PIN), as defined in These are animals in the genera this section, with a producer’s live- Odocoileus, Cervus, and Alces and their stock production numbering system to hybrids, i.e., deer, elk, and moose. provide a unique identification num- Chronic wasting disease (CWD). A ber. The PIN and the production num- transmissible spongiform ber must both appear on the official encephalopathy of cervids. Clinical tag. signs in affected animals include, but (4) Any other numbering system ap- are not limited to, loss of body condi- proved by the Administrator for the tion, behavioral changes, excessive sal- identification of animals in commerce. ivation, increased drinking and urina- Premises identification number (PIN). A tion, depression, and eventual death. nationally unique number assigned by CWD Herd Certification Program. The a State, Tribal, and/or Federal animal Chronic Wasting Disease Herd Certifi- health authority to a premises that is, cation Program established in part 55 in the judgment of the State, Tribal, of this chapter. and/or Federal animal health author- Deer, elk, and moose. All animals in ity, a geographically distinct location the genera Odocoileus, Cervus, and from other premises. The premises Alces and their hybrids. identification number is associated Farmed or captive. Privately or pub- with an address, geospatial coordi- licly maintained or held for economic nates, and/or location descriptors or other purposes within a perimeter which provide a verifiably unique loca- fence or confined area, or captured tion. The premises identification num- from a wild population for interstate ber may be used in conjunction with a movement and release. producer’s own livestock production National Uniform Eartagging System. A numbering system to provide a unique numbering system for the official iden- identification number for an animal. It tification of individual animals in the may also be used as a component of a United States providing a nationally group/lot identification number. The unique identification number for each premises identification number may animal. The National Uniform consist of:

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(1) The State’s two-letter postal ab- have two forms of animal identifica- breviation followed by the premises’ tion, one of which is official animal assigned number; or identification, and the certificate (2) A seven-character alphanumeric issued in accordance with § 81.4 that ac- code, with the right-most character companies the animal must state that being a check digit. The check digit the source population has been docu- number is based upon the ISO 7064 Mod mented to be low risk for CWD, based 36/37 check digit algorithm. on a CWD surveillance program in wild cervid populations that is approved by § 81.2 Identification of deer, elk, and the State Government of the receiving moose in interstate commerce. State and by APHIS. Each animal required to be identified (c) Animals moved to slaughter. The by this part must have at least two farmed or captive deer, elk, or moose forms of animal identification attached must be moved directly to a recognized to the animal. The means of animal slaughtering establishment for slaugh- identification must be approved for ter, must have two forms of animal this use by APHIS, and must be an identification, one of which is official electronic implant, flank tattoo, ear animal identification, and must be ac- tattoo, tamper-resistant ear tag, or companied by a certificate issued in ac- other device approved by APHIS. One cordance with § 81.4. of the animal identifications must be (d) Research animal movements and an official animal identification as de- permits. A research animal permit is re- fined in this part, with a nationally quired for the interstate movement of unique animal identification number cervids for research purposes. The per- that is linked to that animal in the mit will specify any special conditions CWD National Database or in an ap- of the movement determined by the proved State database. The second ani- Administrator to be necessary to pre- mal identification must be unique for vent the dissemination of CWD. The the individual animal within the herd Administrator may, at his or her dis- and also must be linked to that animal cretion, issue the permit if he or she and herd in the CWD National Data- determines that the destination facil- base or in an approved State database. ity has adequate biosecurity and that (Approved by the Office of Management and the movement authorized will not re- Budget under control number 0579–0237) sult in the interstate dissemination of CWD. § 81.3 General restrictions. (1) To apply for a research animal No farmed or captive deer, elk, or permit, contact an APHIS employee or moose may be moved interstate unless State representative and provide the it meets the requirements of this sec- following information: tion. (i) The name and address of the per- (a) Animals in the CWD Herd Certifi- son to whom the special permit is cation Program. The captive deer, elk, issued, the address at which the re- or moose is: search cervids to be moved interstate (1) Enrolled in the CWD Herd Certifi- are being held, and the name and ad- cation Program and the herd has dress of the person receiving the achieved Certified status in accordance cervids to be moved interstate; with § 55.24 of this chapter; and (ii) The number and type of cervids (2) Is accompanied by a certificate to be moved interstate; issued in accordance with § 81.4 that (iii) The reason for the interstate identifies its herd of origin and that movement; states that the animal’s herd has (iv) Any safeguards in place to pre- achieved Certified status and that the vent transmission of CWD during animal does not show clinical signs as- movement or at the receiving location; sociated with CWD. andP≤(v) The date on which movement (b) Animals captured for interstate will occur. movement and release. If the captive (2) A copy of the research animal per- deer, elk, or moose was captured from mit must accompany the cervids a wild population for interstate move- moved, and copies must be submitted ment and release, each animal must so that a copy is received by the State

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animal health official and the veteri- document may be used to provide this narian in charge for the State of des- information, but only under the fol- tination at least 72 hours prior to the lowing conditions: arrival of the cervids at the destination (1) The document must be a State listed on the research animal permit. form or APHIS form that requires indi- (e) Interstate movements approved by vidual identification of animals; the Administrator. Notwithstanding any (2) A legible copy of the document other provision of this part, interstate must be stapled to the original and movement of farmed or captive deer, each copy of the certificate; elk, and moose may be allowed on a (3) Each copy of the document must case-by-case basis when the Adminis- trator determines that adequate survey identify each animal to be moved with and mitigation procedures are in place the certificate, but any information to prevent dissemination of CWD and pertaining to other animals, and any issues a permit for the movement. unused space on the document for recording animal identification, must be § 81.4 Issuance of certificates. crossed out in ink; and (a) Information required on certificates. (4) The following information must A certificate must show any official be typed or written in ink in the iden- animal identification numbers of each tification column on the original and animal to be moved. A certificate must each copy of the certificate and must also show the number of animals cov- be circled or boxed, also in ink, so that ered by the certificate; the purpose for no additional information can be which the animals are to be moved; the added: points of origin and destination; the (i) The name of the document; and consignor; and the consignee. The cer- (ii) Either the serial number on the tificate must include a statement by document or, if the document is not the issuing accredited veterinarian, imprinted with a serial number, both State veterinarian, or Federal veteri- the name of the person who issued the narian that the animals were not ex- document and the date the document hibiting clinical signs associated with was issued. CWD at the time of examination. The certificate must also include a state- (Approved by the Office of Management and ment that the animals are from a herd Budget under control number 0579–0237) that has achieved Certified status in the CWD Herd Certification Program, § 81.5 Movement of deer, elk, or moose and must provide the herd’s program through a State to another State. status, with the following exceptions: Farmed or captive deer, elk, or (1) Certificates issued for animals moose may be moved through a State captured from a wild population for or locality whose laws or regulations interstate movement and release do on the movement of those animals are not need to state that the animals are more restrictive than this part to an- from a herd that has achieved Certified other State under the following condi- status in the CWD Herd Certification tions: Program but must include the statement required in § 81.3(b); and (a) The farmed or captive deer, elk, (2) Certificates issued for animals or moose must be eligible to move moved directly to slaughter do not interstate under § 81.3. need to state that the animals are from (b) The farmed or captive deer, elk, a herd that has achieved Certified sta- or moose must meet the entry require- tus in the CWD Herd Certification Pro- ments of the destination State listed gram and must state that an APHIS on the certificate or permit accom- employee or State representative has panying the animal. been notified in advance of the date the (c) Except in emergencies, the farmed animals are being moved to slaughter. or captive deer, elk, or moose must not (b) Animal identification documents at- be unloaded until their arrival at their tached to certificates. As an alternative destination. to typing or writing individual animal identification on a certificate, another

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§ 81.6 Federal preemption of State and SOURCE: 61 FR 56883, Nov. 5, 1996, unless local laws and regulations with re- otherwise noted. spect to CWD. State and local laws and regulations Subpart A—Exotic Newcastle on farmed or captive deer, elk, or Disease (END) moose with respect to CWD that are more restrictive than the regulations § 82.1 Definitions. in this part are not preempted by this As used in connection with this subpart, except as described in § 81.5. part, the following terms shall have the meaning set forth in this section. PART 82—EXOTIC NEWCASTLE DIS- Administrator. The Administrator of EASE (END) AND CHLAMYDI- the Animal and Plant Health Inspec- OSIS tion Service or any individual authorized to act for the Administrator. Subpart A—Exotic Newcastle Disease Animal and Plant Health Inspection (END) Service. The Animal and Plant Health Inspection Service of the United States Sec. Department of Agriculture. 82.1 Definitions. 82.2 Criteria for determining birds or poul- Bird. Any member of the class aves try to be infected with, exposed to, or other than poultry. free from END. Commercial birds. Birds that are 82.3 Quarantined areas. moved or kept for resale, breeding, 82.4 General provisions. public display, or any other purpose, 82.5 Interstate movement of live birds and except pet birds. live poultry from a quarantined area. Dressed carcasses. Carcasses of birds 82.6 Interstate movement of dead birds and dead poultry from a quarantined area. or poultry that have been eviscerated, 82.7 Interstate movement of manure and lit- with heads and feet removed, or parts ter from a quarantined area. or products of such carcasses. 82.8 Interstate movement of eggs, other END. Any virulant Newcastle disease. than hatching eggs, from a quarantined END is an acute, rapidly spreading, and area. usually fatal viral disease of birds and 82.9 Interstate movement of hatching eggs poultry. from a quarantined area. 82.10 Interstate movement of vehicles, Exposed. At risk of developing END cages, coops, containers, troughs, and because of association with birds or other equipment from a quarantined poultry infected with END, excrement area. from birds or poultry infected with 82.11 Issuance of permits. END, or other material touched by 82.12 Other interstate movements and spe- birds or poultry infected with END, or cial permits. because there is reason to believe that 82.13 Denial and withdrawal of permits and special permits. association has occurred with END or 82.14 Removal of quarantine. vectors of END, as determined by ei- 82.15 Replacement birds and poultry. ther a Federal veterinarian or a State 82.16 Extraordinary emergencies: applica- veterinarian. bility of regulations. Federal representative. An individual employed and authorized by the Fed- Subpart B—Chlamydiosis in Poultry eral government to perform the tasks 82.19 Definitions. required by this subpart. 82.20 General restrictions. Federal veterinarian. A veterinarian 82.21 Vehicles, cages, coops, containers, employed and authorized by the Fed- troughs, and other equipment used for eral government to perform the tasks infected poultry. required by this subpart. 82.22 Cleaning and disinfecting premises. 82.23 Issuance of permits. Hatching eggs. Eggs in which birds or 82.24 Other interstate movements and spe- poultry are allowed to develop. cial permits. Infected. Affected by the virus or bac- 82.25 Denial and withdrawal of permits and terium that causes the specified dis- special permits. ease. AUTHORITY: 7 U.S.C. 8301–8317; 7 CFR 2.22, Interstate. From one State into or 2.80, and 371.4. through any other State.

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Known to be exposed. Determined by Islands, Guam, the Virgin Islands of either a Federal veterinarian or a the United States, or any other terri- State veterinarian to be at risk of de- tory or possession of the United States. veloping END because of association State animal health official. The State with birds or poultry infected with official responsible for livestock- and END, excrement from birds or poultry poultry-disease control and eradication infected with END, or other material programs. touched by birds or poultry infected State representative. An individual em- with END, or because there is reason to ployed in animal health work and au- believe that association has occurred thorized by a State or political subdivi- with END or vectors of END, as deter- sion of a State to perform the tasks re- mined by either a Federal veterinarian quired by this subpart. or a State veterinarian. State veterinarian. A veterinarian em- Known to be infected. Determined by ployed and authorized by a State or po- either a Federal veterinarian or a litical subdivision of a State to per- State veterinarian to be affected by the form the tasks required by this sub- virus or bacterium that causes the part. specified disease. Veterinarian in charge. A Federal vet- Litter. Material that is used to collect erinarian employed by the Animal and and absorb bodily wastes from birds or Plant Health Inspection Service and poultry. authorized by the Administrator to su- Moved. Shipped, transported or other- pervise and manage the animal health wise moved, or delivered or received for work of the Animal and Plant Health movement, by any person. Inspection Service in a specified area Official seal. A serially numbered of the United States. metal or plastic strip, consisting of a [61 FR 56883, Nov. 5, 1996, as amended at 73 self-locking device on one end and a 30297, May 27, 2008; 74 FR 18287, Apr. 22, 2009] slot on the other end, that forms a loop when the ends are engaged and that § 82.2 Criteria for determining birds or cannot be reused if opened, or a seri- poultry to be infected with, exposed to, or free from END. ally numbered, self-locking button that can be used for this purpose. (a) The determination that birds or Person. Any individual, corporation, poultry are infected with END must be company, association, firm, partner- made by either a Federal veterinarian ship, society, joint stock company, or or a State veterinarian. 1 They will other legal entity. base that determination on one or Pet birds. Birds, except ratites, that more of the following factors: clinical are kept for the personal pleasure of evidence (signs, post-mortem lesions, their individual owners and are not in- and history of the occurrence of END); tended for resale. diagnostic tests; 2 or epidemiological Poultry. Chickens, doves, ducks, evidence (evaluation of clinical evi- geese, grouse, guinea fowl, partridges, dence and the degree of risk posed by pea fowl, pheasants, pigeons, quail, the potential spread of END based on swans, and turkeys. Ratites. Cassowaries, emus, kiwis, os- 1 The location of Federal veterinarians and triches, and rheas. State veterinarians may be obtained by writ- Recognized slaughtering establishment. ing to Emergency Programs, Veterinary Services, Animal and Plant Health Inspec- Any slaughtering facility operating tion Service, 4700 River Road, Unit 41, River- under the Federal Meat Inspection Act dale, MD 20737–1231, or by referring to the (21 U.S.C. 601 et seq.), the Poultry Prod- local telephone book. ucts Inspection Act (21 U.S.C. 451 et 2 A copy of the protocols for END diag- seq.), or State meat or poultry inspec- nostic tests may be obtained by writing to tion acts. Emergency Programs, Veterinary Services, Render. Reduce, convert, or melt Animal and Plant Health Inspection Service, down by heating to a temperature of at 4700 River Road Unit 41, Riverdale, MD 20737– ° 1231. The protocols are also found in ‘‘Rec- least 230 F so that oil is removed. ommended Uniform Diagnostic Procedures,’’ State. Each of the States of the published by the Committee of the American United States, the District of Colum- Association of Veterinary Laboratory Diag- bia, Puerto Rico, the Northern Mariana nosticians.

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population and exposure factors, in- main designated as a quarantined area cluding evaluation of whether the birds until all of the requirements of § 82.14 and poultry have had the opportunity have been met. to be in contact with birds or poultry (c) The following areas are quar- infected with END or with excrement antined because of END: There are no from birds or poultry infected with areas in the United States quarantined END, or if the birds and poultry have because of END. shared feed or water with birds or poultry infected with END). [61 FR 56883, Nov. 5, 1996, as amended at 67 FR 70675, Nov. 26, 2002; 68 FR 1517, Jan. 13, (b) The determination that birds or 2003; 68 FR 3376, Jan. 24, 2003; 68 FR 7413, Feb. poultry are exposed to END must be 14, 2003; 68 FR 18532, Apr. 16, 2003; 68 FR 26987, made by either a Federal veterinarian 26989, May 19, 2003; 68 FR 34781, June 11, 2003; or a State veterinarian. They will base 68 FR 45744, Aug. 4, 2003; 68 FR 54800, Sept. 19, that determination on an evaluation of 2003] all related circumstances, including: the proximity of the birds or poultry to § 82.4 General provisions. birds or poultry infected with END, to (a) Prohibitions. The following arti- excrement from birds or poultry in- cles may not be moved interstate from fected with END, and to other material a quarantined area: touched by birds or poultry infected (1) Dead birds and dead poultry, in- with END; the number of birds or poul- cluding any parts of the birds or poultry infected with END to which the try, that are infected with END, or are birds or poultry were exposed; the spe- from a flock of birds or poultry in- cies involved; the virulence of the END fected with END; to which the birds or poultry were ex- (2) Litter used by or manure gen- posed; and the length of time the birds erated by birds or poultry, or a flock of or poultry were in contact with birds birds or poultry, infected with END, or poultry infected with END, and to except as provided in § 82.7(b); material touched by birds or poultry (3) Any eggs from birds or poultry, or infected with END. Birds or poultry de- a flock of birds or poultry, infected termined to be exposed to END will with END; continue to be treated as exposed un- (4) Hatching eggs from flocks of birds less they are subsequently determined or poultry exposed to END; and to be infected with END or until either (5) Live birds or live poultry from a Federal veterinarian or a State vet- flocks infected with or exposed to END. erinarian finds them to be free of END (b) Restrictions. The following articles based on one or more of the factors may be moved interstate from a quar- listed in paragraph (a) of this section. antined area only in accordance with (Approved by the Office of Management and this subpart: Budget under control number 0579–0116) (1) Live birds or live poultry not known to be infected with or exposed § 82.3 Quarantined areas. to END; (a) Any area where birds or poultry (2) Dressed carcasses of birds and infected with END are located will be poultry, and other dead birds and dead designated as a quarantined area. A poultry, including any parts of the quarantined area is any geographical birds or poultry, that are not known to area, which may be a premises or all or be infected with END; part of a State, deemed by epidemio- (3) Litter used by or manure gen- logical evaluation to be sufficient to erated by birds or poultry not known contain all birds or poultry known to to be infected with END; be infected with or exposed to END. (4) Eggs, other than hatching eggs, Less than an entire State will be des- from birds or poultry from flocks not ignated as a quarantined area only if known to be infected with END; the State enforces restrictions on (5) Hatching eggs from birds or poul- intrastate movements from the quar- try not known to be infected with or antined area that are at least as strin- exposed to END; and gent as this subpart. (6) Cages, coops, containers, troughs, (b) Any area designated as a quar- vehicles, or other equipment used for antined area because of END will re- birds, poultry, eggs, manure, or litter.

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(c) Exceptions. This subpart does not interstate movement. The individual to apply to the interstate movement of whom the permit is issued must allow birds, poultry, or other articles from a Federal representatives and State rep- quarantined area if the interstate resentatives to examine the birds at movement is made by the United any time until they are declared free of States Department of Agriculture for END by either a Federal veterinarian purposes of research or diagnosis. or a State veterinarian. [61 FR 56883, Nov. 5, 1996, as amended at 73 (ii) All other pet birds. Pet birds that 30297, May 27, 2008] do not meet the criteria in paragraph (a)(2)(i) of this section may only be § 82.5 Interstate movement of live moved to a USDA-approved quarantine birds and live poultry from a quar- facility outside the quarantined area antined area. for a 30-day quarantine before being re- (a) Pet birds. An individual may move leased. The individual to whom the per- his or her pet birds interstate from a mit is issued must maintain ownership quarantined area only if the birds are and control of the birds and maintain not known to be infected with or ex- them isolated from other birds or poul- posed to END and the following re- try until the time they arrive at the quirements are fulfilled: USDA-approved quarantine facility. (1) Epidemiological and testing require- The pet bird owner is responsible for ments. For all pet birds moved inter- all costs associated for keeping his or state, epidemiological evidence must her pet birds at the USDA-approved indicate that the birds are not infected quarantine facility for the 30-day quar- with any communicable disease. antine period. (i) Pet birds that have been under the (2) Movement restrictions. All pet birds control and ownership of the owner for at must be moved interstate from a quar- least 90 days. Pet birds that have been antined area under the following condi- under the ownership and control of the tions: individual to whom the permit is issued for the 90 days before interstate (i) The birds are accompanied by a movement, show no clinical signs of permit obtained in accordance with sickness (such as diarrhea, nasal dis- § 82.11. charge, ocular discharge, ruffled feath- (ii) The birds are moved interstate by ers, or lack of appetite) during the 90 the individual to whom the permit is days before interstate movement, and issued. have been maintained apart from other (iii) The birds are caged while being birds and poultry in the quarantined moved interstate. area during the 90 days before inter- (iv) Within 24 hours of a bird’s dying state movement may be moved to a lo- or showing clinical signs of sickness cation outside the quarantined area for (such as diarrhea, nasal discharge, ocu- subsequent examination. The indi- lar discharge, ruffled feathers, or lack vidual to whom the permit is issued of appetite), the individual to whom must maintain ownership and control the permit is issued notifies the veteri- of the birds and maintain them apart narian in charge or the State animal from other birds and poultry from the health official 4 in the State to which time they arrive at the place to which the birds are moved. the individual is taking them until a (v) The individual to whom the per- Federal representative or State rep- mit is issued submits copies of the per- resentative 3 examines the birds and de- mit so that a copy is received by the termines that the birds show no clin- State animal health official and the ical signs of END. The examination veterinarian in charge for the State of will not be less than 30 days after the 4 The location of the veterinarian in charge 3 The location of Federal representatives or the State animal health official may be and State representatives may be obtained obtained by writing to Emergency Programs, by writing to Emergency Programs, Veteri- Veterinary Services, Animal and Plant nary Services, Animal and Plant Health In- Health Inspection Service, 4700 River Road, spection Service, 4700 River Road, Unit 41, Unit 41, Riverdale, MD 20737–1231, or by refer- Riverdale, MD 20737–1231. ring to the local telephone book.

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destination within 72 hours of the ar- § 82.6 Interstate movement of dead rival of the birds at the destination birds and dead poultry from a quar- listed on the permit. antined area. (b) Other birds (including commercial (a) Except as provided in paragraph birds) and poultry. Except as provided (b) of this section for dressed carcasses, for pet birds in paragraph (a) of this dead birds and dead poultry, including section, a person may move live birds any parts of the birds and poultry, that (including commercial birds) and live are not known to be infected with END poultry that are not known to be in- may be moved interstate from a quar- fected with or exposed to END inter- antined area only if: state from a quarantined area only if: (1) The dead birds and dead poultry (1) The birds and poultry are accom- are accompanied by a permit obtained panied by a permit obtained in accord- in accordance with § 82.11; ance with § 82.11; (2) The dead birds and dead poultry (2) The birds or poultry are covered are covered in such a way as to prevent in such a way as to prevent feathers feathers and other debris from blowing and other debris from blowing or fall- or falling off the means of conveyance; ing off the means of conveyance; (3) The dead birds and dead poultry are moved in a means of conveyance ei- (3) The birds or poultry are moved in ther under official seal or accompanied a means of conveyance either under of- by a Federal representative; ficial seal or are accompanied by a (4) The dead birds and dead poultry Federal representative; are not unloaded until their arrival at (4) Except for emergencies, the birds the destination listed on the permit re- or poultry are not unloaded until their quired by paragraph (a)(1) of this sec- arrival at the destination listed on the tion; permit required by paragraph (b)(1) of (5) The dead birds and dead poultry this section; are moved, without stopping, to the (5) If poultry or ratites, the poultry destination listed on the permit re- or ratites are moved interstate to a quired by paragraph (a)(1) of this sec- recognized slaughtering establish- tion, except for normal traffic condi- ment 5 and are slaughtered within 24 tions, such as traffic lights and stop hours of arrival at the recognized signs; slaughtering establishment; (6) The dead birds and dead poultry (6) If birds other than poultry, the are disposed of, within 24 hours after birds are moved to a site approved by being loaded for interstate movement, the Administrator; and by burial or composting in accordance (7) The permit required by paragraph with the procedures set forth in (b)(1) of this section is presented upon § 82.14(c)(1) and (c)(2), or by rendering, arrival at the recognized slaughtering incineration, or other means approved establishment or approved site to a by the Administrator as being ade- State representative or Federal rep- quate to prevent the dissemination of resentative. Copies of the permit must END; and also be submitted so that a copy is re- (7) Copies of the permit accom- ceived by the State animal health offi- panying the dead birds and dead poul- cial and the veterinarian in charge for try interstate are submitted so that a the State of destination within 72 copy is received by the State animal hours of arrival at the recognized health official and the veterinarian in slaughtering establishment. charge for the State of destination within 72 hours of the arrival of the (Approved by the Office of Management and dead birds and dead poultry at the des- Budget under control number 0579–0116) tination listed on the permit required [61 FR 56883, Nov. 5, 1996, as amended at 73 by paragraph (a)(1) of this section. 30297, May 27, 2008] (b) Dressed carcasses from birds and poultry that are not known to be in- 5 A list of recognized slaughtering estab- fected with END may be moved inter- lishments in any State may be obtained from state from a quarantined area only if: a Federal representative, the State animal (1) The dressed carcasses are from health official, or a State representative. birds or poultry that were slaughtered

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in a recognized slaughtering establish- normal traffic conditions, such as traf- ment; 6 fic lights and stop signs; and (2) The dressed carcasses have been (8) Copies of the permit accom- processed in one of the following ways: panying the dressed carcasses are sub- (i) They are packed in hermetically mitted so that a copy is received by the sealed containers and cooked by a com- State animal health official and the mercial method after such packing to veterinarian in charge for the State of produce articles which are shelf-stable destination within 72 hours of the ar- without refrigeration; or rival of the dressed carcasses at the (ii) They have been thoroughly destination listed on the permit re- cooked and have a thoroughly cooked quired by paragraph (b)(4) of this sec- appearance throughout; tion. (3) If the dressed carcasses are from poultry, the processing establishment (Approved by the Office of Management and Budget under control number 0579–0116) that treats the dressed carcasses in accordance with paragraph (b)(2) of this [61 FR 56883, Nov. 5, 1996, as amended at 73 section employs the following safe- 30298, May 27, 2008] guards: (i) If receiving or handling any live § 82.7 Interstate movement of manure and litter from a quarantined area. poultry, there must be complete separation between the slaughter portion of (a) Manure generated by and litter the establishment and the portions of used by birds or poultry not known to the establishment in which further be infected with END may be moved processing takes place; interstate from a quarantined area (ii) If the plant processes dressed car- only if: casses from both quarantined and non- (1) The manure and litter is accom- quarantined areas, all areas, utensils, panied by a permit obtained in accord- and equipment likely to contact the ance with § 82.11; poultry carcasses to be processed, in- (2) The manure and litter has been cluding skimming, deboning, cutting, heated throughout, in the quarantined and packing areas, are cleaned and dis- area, to a temperature of not less than infected in accordance with part 71 of 175 °F (79.4 °C) or subjected to any this chapter between the processing of other treatment approved by the Ad- dressed poultry carcasses from the ministrator as being adequate to pre- quarantined area and the processing of vent the dissemination of END, and dressed poultry carcasses from non- then placed either in a previously unquarantined areas; used container or in a container that (iii) The dressed carcasses are stored has been cleaned and disinfected, since in a manner that ensures that no cross- last being used, in accordance with contamination with potentially infec- part 71 of this chapter; tious materials, such as raw or unproc- (3) The declaration or affidavit re- essed products, occurs; quired by § 82.11(b) lists the location of (4) The dressed carcasses are accom- the poultry or birds that generated the panied by a permit obtained in accord- manure or used the litter, and the ance with § 82.11; name and address of the owner of the (5) The dressed carcasses are moved poultry or birds that generated the main a means of conveyance either under nure or used the litter; and official seal or accompanied by a Fed- (4) Copies of the permit accom- eral representative; panying the manure and litter inter- (6) The dressed carcasses are not un- state are submitted so that a copy is loaded until their arrival at the des- received by the State animal health of- tination listed on the permit required ficial and the veterinarian in charge by paragraph (b)(4) of this section; for the State of destination within 72 (7) The dressed carcasses are moved, hours of the arrival of the manure and without stopping, to the destination litter at the destination listed on the listed on the permit required by para- permit. graph (b)(4) of this section, except for (b) Compost derived from manure generated by and litter used by birds or 6 See footnote 5 to § 82.5. poultry known to be infected with END

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may be moved interstate from a quar- known to be infected with END may be antined area only if: moved interstate from a quarantined (1) The manure and litter is accom- area only if: panied by a permit obtained in accord- (1) The eggs are accompanied by a ance with § 82.11; permit obtained in accordance with (2) All birds and poultry have been § 82.11; removed from the premises where the (2) The eggs have been cleaned and manure or litter is held; sanitized in accordance with 9 CFR (3) After all birds are removed from part 590; the premises where the manure or lit- (3) The establishment that processes ter is held, all manure and litter inside the eggs, other than hatching eggs, for and outside the bird or poultry house sale establishes procedures adequate to remains undisturbed for at least 28 ensure that the eggs are free of END, days before being moved from the in- including: fected premises for composting; (i) The establishment separates proc- (4) Composting is done at a site ap- essing and layer facilities, the incom- proved by the Administrator and under ing and outgoing eggs at the establish- a protocol approved by the Adminis- ment, and any flocks that may reside trator as being adequate to prevent the at the establishment; dissemination of END. All manure and (ii) The establishment implements litter from the infected premises must controls to ensure that trucks, ship- be moved to the composting site at the ping companies, or other visitors do same time; not expose the processing plant to (5) Following the composting process, END; the composted manure or litter re- (iii) Equipment used in the establish- mains undisturbed for an additional 15 ment is cleaned and disinfected in ac- days before movement; cordance with part 71 of this chapter at (6) After this 15-day period, all of the intervals determined by the Adminis- composted manure or litter from the trator to ensure that the equipment infected site is removed at the same cannot transmit END to the eggs, time; other than hatching eggs, being proc- (7) The resulting compost must be essed; and transported either in a previously unused container or in a container that (iv) The eggs are packed either in has been cleaned and disinfected, since previously unused flats or cases, or in last being used, in accordance with used plastic flats that were cleaned or part 71 of this chapter; disinfected since last being used, in ac- (8) The vehicle in which the resulting cordance with part 71 of this chapter; compost is to be transported has been (4) The eggs are moved to a facility cleaned and disinfected, since last where they are examined to ensure being used, in accordance with part 71 they have been cleaned and sanitized in of this chapter; and accordance with paragraph (a)(2) of (9) Copies of the permit accom- this section; and panying the compost derived from the (5) Copies of the permit accom- manure and the litter are submitted so panying the eggs interstate are sub- that a copy is received by the State mitted so that a copy is received by animal health official and the veteri- both the State animal health official narian in charge for the State of des- and the veterinarian in charge for the tination within 72 hours of arrival of State of destination within 72 hours of the compost at the destination listed the arrival of the eggs at the facility. on the permit. (b) Any flats or cases intended for reuse after being used to move eggs [61 FR 56883, Nov. 5, 1996, as amended at 73 interstate to a facility under this sec- 30298, May 27, 2008] tion must be cleaned and disinfected in § 82.8 Interstate movement of eggs, accordance with part 71 of this chapter other than hatching eggs, from a before being moved to a premises quarantined area. where birds or poultry are kept. (a) Eggs, other than hatching eggs, [61 FR 56883, Nov. 5, 1996, as amended at 73 from birds or poultry from flocks not 30299, May 27, 2008]

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§ 82.9 Interstate movement of hatching area only in accordance with the fol- eggs from a quarantined area. lowing conditions: Hatching eggs from birds or poultry (1) They are made of hard plastic or not known to be infected with or ex- metal, and the other conditions of this posed to END may be moved interstate section are met; or from a quarantined area only if: (2) They are made of a disposable ma- (a) The hatching eggs are accom- terial, such as cardboard, fiber, or panied by a permit obtained in accord- waxed cardboard, are previously un- ance with § 82.11; used, and are disposed of by inciner- (b) Copies of the permit accom- ation without being reused after being panying the hatching eggs are sub- moved interstate. mitted so that a copy is received by (c) Before moving interstate any ve- both the State animal health official hicles, cages, coops, containers, and the veterinarian in charge for the troughs, or other equipment described State of destination within 72 hours of in paragraph (b)(1) of this section, and the arrival of the hatching eggs at the after using these items to move birds, premises described in paragraph (c) of poultry, eggs, manure, or litter inter- this section; state from a quarantined area, the ve- (c) The hatching eggs have been kept hicles, cages, coops, containers, in accordance with the sanitation prac- troughs, and other equipment must be tices specified in §§ 147.22 and 147.25 of cleaned and disinfected in accordance the National Poultry Improvement with paragraphs (c)(1) through (c)(5) of Plan; and this section: (d) The hatching eggs are held in the (1) Clean and disinfect the vehicles, State of destination at a premises des- cages, coops, containers, troughs, and ignated jointly by the veterinarian in other equipment at the place where the charge and the State animal health of- birds, poultry, eggs, manure, and litter ficial from the time of arrival until are unloaded or where the equipment is hatch and the birds and poultry used, no more than 2 hours after the hatched from the eggs are held at the birds, poultry, eggs, manure, and litter designated premises for not less than 30 are unloaded or the equipment is used; days following hatch. During this hold- (2) Clean the items in accordance ing period, the eggs and any birds or with part 71 of this chapter; poultry hatched from the eggs are sub- (3) Have a Federal representative or ject to any inspections, disinfections, State representative 7 inspect the items and tests as may be required by the Ad- after they have been cleaned; ministrator to determine their freedom (4) Disinfect the items in the pres- from END. ence of a Federal representative or State representative; and [61 FR 56883, Nov. 5, 1996, as amended at 73 (5) Disinfect the items in accordance 30299, May 27, 2008] with part 71 of this chapter and by § 82.10 Interstate movement of vehi- using a disinfectant as specified in part cles, cages, coops, containers, 71 of this chapter. troughs, and other equipment from (d) If the place where the cleaning a quarantined area. and disinfection would otherwise be re- (a) This section does not apply to quired has no facilities for cleaning and cages, coops, or other containers or disinfecting, the items may be moved equipment used by or to move pet birds to a place where facilities are available moved interstate in accordance with for cleaning and disinfecting, provided § 82.5(a). a Federal representative or State rep- (b) Vehicles, cages, coops, containers, resentative has determined that such troughs, and other equipment that movement will not cause a risk of the have held or that have otherwise been spread of END. used in a quarantined area in the han- (e) Vehicles, cages, coops, containers, dling of birds or poultry or their eggs, troughs, and other equipment that are or for manure generated by or litter moved interstate under this section used by the birds or poultry, may be moved interstate from a quarantined 7 See footnote 3 to § 82.5.

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must be accompanied by a permit ob- interstate only if all of the listed retained in accordance with § 82.11, and quirements are met. copies of the permit accompanying the vehicles, cages, coops, containers, (Approved by the Office of Management and Budget under control number 0579–0116) troughs, and other equipment interstate must be submitted so that a copy § 82.12 Other interstate movements is received by the State animal health and special permits. official and the veterinarian in charge 8 for the State of destination within 72 (a) A special permit is required for hours of the arrival of the vehicles, the interstate movement of birds, poul- cages, coops, containers, troughs, and try, or other items whose movement is other equipment at the destination restricted under this subpart, from a listed on the permit. quarantined area in a manner or to a destination other than is specifically (Approved by the Office of Management and prescribed by this subpart, under spe- Budget under control number 0579–0116) cial conditions determined by the Ad- ministrator to be necessary to prevent § 82.11 Issuance of permits. the dissemination of END. A special (a) Application for the permits re- permit is required for the disposal of quired by this subpart to move inter- dead birds or dead poultry that are in- state from a quarantined area birds, fected with END, or dead birds or dead eggs, poultry, or other items requiring poultry from flocks infected with END, a permit under this part must be in or manure generated by or eggs from writing. The application must be sub- birds or poultry infected with END, in mitted to a Federal representative or a manner other than is specifically pre- State representative and must include scribed in this subpart, and for clean- the following: ing and disinfection carried out in a (1) The applicant’s name and mailing manner other than is specifically pre- address; scribed in this subpart, under special (2) The name and mailing address of conditions determined by the Adminis- the person who will receive the birds, trator to be necessary to prevent the eggs, poultry, or other items; dissemination of END. To apply for a (3) The addresses of both the origin special permit, contact the veteri- and destination of the birds, eggs, poul- narian in charge 9 for the State in try, or other items; which the birds, poultry, or other (4) The number and types of birds, items are located. The Administrator poultry, eggs, and other items intended may, at his or her discretion, issue spe- for interstate movement; and cial permits if he or she determines (5) The reason for the interstate that the activity authorized will not movement. (b) In addition to the information re- result in the interstate dissemination quired by paragraph (a) of this section, of END. to obtain permits to move birds, poul- (b) The special permit will list the try, eggs, manure, litter, cages, coops, name and address of the person to containers, troughs, vehicles or other whom the special permit is issued, and equipment interstate from a quar- the special conditions under which the antined area, an applicant for a permit interstate movement, disposal, or must submit to a Federal representa- cleaning and disinfection may be car- tive or State representative a declara- ried out. tion or affidavit listing the require- (1) For an interstate movement, the ments of § 82.5 for live birds or live special permit will also include the fol- poultry, § 82.6 for dead birds and dead lowing: poultry, § 82.7 for litter or manure, (i) The name and mailing address of § 82.8 for eggs other than hatching eggs, the person who will receive the birds, § 82.9 for hatching eggs, or § 82.10 for poultry, or other items; cages, coops, containers, troughs, vehi- (ii) The addresses of both the origin cles, and other equipment, and stating and destination of the birds, poultry, that the applicant will move the items or other items;

8 See footnote 4 of § 82.5. 9 See footnote 4 to § 82.5.

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(iii) The number and type of birds, or safety. The Administrator will send poultry, or other items to be moved the person to whom the permit or spe- interstate; and cial permit has been issued a written (iv) The reason for the interstate explanation of why the permit or spe- movement. cial permit is to be or was withdrawn. (2) For destruction or cleaning and (c) Appeals. Denial or withdrawal of a disinfection, the special permit will permit or special permit may be ap- also include the following: pealed to the Administrator within 10 (i) The address of the place where the days after receipt of the written notice dead birds, dead poultry, manure, or of denial or withdrawal. The appeal eggs are located; and must be in writing 10 and must state all (ii) The number and type of birds, of the facts and reasons upon which the poultry, or other items involved. person relies to show that the permit (c) For an interstate movement, a or special permit was wrongfully de- copy of the special permit must accom- nied or withdrawn. The Administrator pany the items moved, and copies must will grant or deny the appeal, in writ- be submitted so that a copy is received ing, explaining all of the reasons for by the State animal health official and the decision, as promptly as cir- the veterinarian in charge for the cumstances allow. In cases where there State of destination within 72 hours of is a conflict as to any material fact, the arrival of the birds, poultry, or the person denied a permit or special other items at the destination listed on permit, or from whom a permit or spe- the special permit. cial permit is withdrawn, shall be given (Approved by the Office of Management and an opportunity for a hearing with re- Budget under control number 0579–0116) spect to the merits of the validity of the denial or withdrawal in accordance § 82.13 Denial and withdrawal of per- with rules of practice adopted for the mits and special permits. proceeding. (a) Denial. If the Administrator determines that the applicant for a per- (Approved by the Office of Management and mit or special permit is not complying Budget under control number 0579–0116) with or could not comply with this sub- § 82.14 Removal of quarantine. part or any special conditions needed to prevent the dissemination of END, An area will be removed from quar- or, in the case of a special permit, that antine only when all of the following the special permit is not required requirements have been met: under this subpart, the Administrator (a) All birds and poultry exposed to may deny the request for a permit or END in the quarantined area have been special permit. If the request is denied, found to be free of END; the Administrator will send the appli- (b) All birds and poultry infected cant a written notice explaining why with END in the quarantined area have the permit or special permit was de- been euthanized; nied. (c) All birds and poultry, including (b) Withdrawal. The Administrator any parts of the birds and poultry, may withdraw a permit or special per- euthanized in accordance with para- mit, orally or in writing, if he or she graph (b) of this section, and all birds determines the person to whom the and poultry in the quarantined area, permit or special permit has been including any parts of the birds and issued is violating either this subpart poultry, that died from any cause other or some condition specified in the per- than slaughter, have been buried, remit or special permit. The Adminis- duced to ashes by incineration, ren- trator may withdraw the permit or spe- dered, or reduced to dust by cial permit without advance notice if composting: he or she determines that the person to whom the permit or special permit has 10 Written appeals should be sent to the Ad- been issued is violating either this sub- ministrator, c/o Emergency Programs, Vet- part or some condition specified in the erinary Services, Animal and Plant Health permit or special permit in a way that Inspection Service, 4700 River Road, River- threatens the public health, interest, dale, MD 20737–1231.

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(1) If the birds and poultry are bur- product may not be spread or otherwise ied, all birds and poultry infected with utilized until at least 30 days following END must be buried in the quarantined completion of the second heating cycle. area. The birds and poultry must be (iii) Composting of birds and poultry buried in a location that meets all must be carried out at least 50 yards United States Environmental Protec- from any building or pen where poultry tion Agency, State, and local require- and birds are housed and be inacces- ments for landfills. They must be bur- sible to birds and poultry. Composted ied at least 6 feet deep and be covered material may not be commingled with, at the time of burial with soil; and or otherwise be brought into contact (2) If the birds and poultry are with, non-composted manure cake; composted, all birds and poultry in- (d) All eggs produced by birds or fected with END must be composted in poultry infected with or exposed to the quarantined area. The birds and END in the quarantined area have been poultry must be composted according buried, reduced to ashes by inciner- to the following instructions or accord- ation, or rendered. If the eggs are bur- ing to another procedure approved by ied, the eggs must be buried in the the Administrator as being adequate to quarantined area in a location that prevent the dissemination of END: meets all United States Environmental (i) Place a 1-foot layer of litter and Protection Agency requirements and manure in a free-standing composter all State and local requirements for bin, unless the compost pile will be landfills. The eggs must be buried at covered in accordance with paragraph least 6 feet deep and be covered at the (c)(2)(ii) of this section. Add a 6-inch time of burial with soil; layer of straw, peanut hulls, or wood (e) All manure generated by or litter chips. Add a layer of dead birds or dead used by birds or poultry infected with poultry, leaving 6 inches between the or exposed to END in the quarantined carcasses and the bin walls. Add water area has been reduced to ashes by in- sparingly and cover with 6 inches of a cineration, or has been buried, dry mixture of litter and manure. Re- composted, or spread on a field and peat the layering process two more turned under, as follows: times and cap with a double layer of (1) Burial. If the manure or litter is dry manure cake. After the bin is buried, the manure and litter must be capped off and covered, monitor the buried at least 6 feet deep and covered temperature in the compost pile daily, at the time of burial with soil. The ma- using a 36-inch probe-type thermom- nure and litter must be buried in the eter. The temperature of the compost quarantined area in a location that pile must reach at least 140 °F. After 30 meets all United States Environmental days from the date the compost pile is Protection Agency and State and local created, turn over to aerate the entire requirements for landfills; mixture. Allow mixture to reach at (2) Composting. If the manure and lit- least 140 °F once again. After comple- ter is composted, the manure and litter tion of the second cycle, the mixture must be composted in the quarantined must remain covered with any mate- area. The manure and litter must be rial that prevents penetration of air composted according to the following and moisture until spread or otherwise method, or according to another proce- utilized. The composted material may dure approved by the Administrator as not be spread or otherwise utilized being adequate to prevent the dissemi- until at least 30 days following comple- nation of END: Place the manure and tion of the second heating cycle. litter in rows 3 to 5 feet high and 5 to (ii) Composting of birds and poultry 10 feet at the base. The area where the may be accomplished outside of cov- manure, litter, and other material used ered bins by following the layering and in composting are placed must be such temperature requirements set forth in that there is no runoff from the paragraph (c)(2)(i) of this section, then composted material out of the area, no covering the compost pile with tarpau- saturation into the ground, and no lins or 6-mm polyethylene sheets an- moisture, except for that required by chored with tires or straw bales. The this paragraph, onto the composted mixture must be kept moist. The final material from above. The composting

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area must be at least 50 yards from any of this chapter. The items must be in- building or pen where birds or poultry spected after cleaning, and before dis- are housed and be inaccessible to birds infection, by a Federal representative and poultry. The manure and litter or State representative, and then must must be mixed so as to attain a carbon be disinfected in the presence of a Fed- to nitrogen ratio of approximately 30:1, eral representative or State represent- a moisture content of between 40 to 50 ative, with a disinfectant listed in part percent, and a supply of oxygen to the 71 of this chapter; and composted material. If a carbon source (h) The premises where birds or poul- other than manure or litter is needed, try infected with or exposed to END wood chips, straw, or peanut hulls may were located have been cleaned and dis- be used. The manure and litter must be infected in accordance with part 71 of covered with tarpaulin or 6-mm polyethylene sheets, be anchored with tires this chapter. The premises have been or straw bales, and be mixed to ensure inspected after cleaning, and before adequate ventilation every 10 to 15 disinfection, by a Federal representa- days. The composted material must tive or State representative, and then rise to a temperature of 140 °F, as de- have been disinfected in the presence of termined by use of a 36-inch probe-type a Federal representative or State rep- thermometer. The composted material resentative with a disinfectant listed may not be spread or otherwise utilized in part 71 of this chapter. for at least 30 days from the time the (i) After the other conditions of this 140 °F temperature is reached; and section are fulfilled, an area will not be (3) Spreading and turning under. released from quarantine until fol- Spreading and turning under of manure lowup surveillance over a period of or litter may be used as a means of dis- time determined by the Administrator posal only if carried out under the di- indicates END is not present in the rect supervision of a Federal represent- quarantined area. ative or a State representative. If the manure or litter is spread on a field (Approved by the Office of Management and and turned under, the field must be in Budget under control number 0579–0116) the quarantined area, at least 50 yards [61 FR 56883, Nov. 5, 1996, as amended at 73 away from any building or pen where 30299, May 27, 2008] poultry or birds are housed, and inaccessible to birds and poultry. The ma- § 82.15 Replacement birds and poultry. nure or litter must be turned under Birds and poultry that have been de- within 24 hours of being spread on the stroyed because of a quarantine for field, and the field must be left undis- END may not be replaced by birds or turbed for at least 30 days; poultry moved interstate into the (f) All vehicles with which the birds quarantined area until the Adminis- or poultry infected with or exposed to trator decides that END has been END or their excrement or litter have eradicated and that replacement birds had physical contact have been cleaned or poultry will not become infected and disinfected in accordance with part with END. 71 of this chapter. The vehicles have been inspected after cleaning, and be- § 82.16 Extraordinary emergencies; ap- fore disinfection, by a Federal rep- plicability of regulations. resentative or State representative, and then have been disinfected in the When, in accordance with sec. 10407 presence of a Federal representative or of the Animal Health Protection Act (7 State representative with a disinfect- U.S.C. 8306), the Secretary of Agri- ant listed in part 71 of this chapter; culture determines that an extraor- (g) All cages, coops, containers, dinary emergency exists because of troughs, and other equipment used for END, the regulations in this subpart birds or poultry infected with or ex- regarding interstate movement shall be posed to END, or their excrement or applicable to intrastate movement litter have been reduced to ashes by in- within any State or portion of a State cineration, or have been cleaned and subject to the Secretary’s declaration disinfected in accordance with part 71 of extraordinary emergency until such

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time as the Secretary terminates that State. Each of the States of the declaration. United States, the District of Colum- bia, Puerto Rico, the Northern Mariana [68 FR 1517, Jan. 13, 2003] Islands, Guam, the Virgin Islands of the United States, or any other terri- Subpart B—Chlamydiosis in tory or possession of the United States. Poultry State animal health official. The State official responsible for livestock- and § 82.19 Definitions. poultry-disease control and eradication As used in connection with this sub- programs. part, the following terms shall have State representative. An individual em- the meaning set forth in this section. ployed in animal health work and au- Accredited veterinarian. A veteri- thorized by a State or political subdivi- narian approved by the Administrator sion of a State to perform the tasks rein accordance with part 161 of this quired by this subpart. chapter to perform functions specified Veterinarian in charge. A Federal vet- in subchapters B, C, and D of this chap- erinarian employed by the Animal and ter. Plant Health Inspection Service and Administrator. The Administrator of authorized by the Administrator to su- the Animal and Plant Health Inspec- pervise and manage the animal health tion Service or any individual author- work of the Animal and Plant Health ized to act for the Administrator. Inspection Service in a specified area Animal and Plant Health Inspection of the United States. Service. The Animal and Plant Health § 82.20 General restrictions. Inspection Service of the United States Department of Agriculture. The following items may not be Bird. Any member of the class aves moved interstate: other than poultry. (a) Live poultry infected with Chlamydiosis. A contagious bacterial chlamydiosis; disease of birds and poultry, character- (b) Dead poultry that were infected ized by respiratory and systemic infec- with chlamydiosis when they died, and tion. The disease is also known as psit- parts of dead poultry that were in- tacosis in psittacine birds and as orni- fected with chlamydiosis when they thosis in poultry. died; and (c) Offal from poultry infected with Federal representative. An individual chlamydiosis. employed and authorized by the Fed- eral government to perform the tasks § 82.21 Vehicles, cages, coops, con- required by this subpart. tainers, troughs, and other equip- Federal veterinarian. A veterinarian ment used for infected poultry. employed and authorized by the Fed- (a) Before moving vehicles, cages, eral government to perform the tasks coops, containers, troughs, and other required by this subpart. equipment interstate that have held or Infected. Affected by the virus or bac- have otherwise been used in the han- terium that causes the specified dis- dling of poultry infected with ease. chlamydiosis, and after using these Interstate. From one State into or items to move poultry infected with through any other State. chlamydiosis interstate, the vehicles, Moved. Shipped, transported or other- cages, coops, containers, troughs, and wise moved, or delivered or received for other equipment must be cleaned and movement, by any person. disinfected in accordance with para- Person. Any individual, corporation, graphs (a)(1) through (a)(5) of this sec- company, association, firm, partner- tion: ship, society, joint stock company, or (1) Clean and disinfect the vehicles, other legal entity. cages, coops, containers, troughs, and Poultry. Chickens, doves, ducks, other equipment at the place where the geese, grouse, guinea fowl, partridges, poultry are unloaded or where the pea fowl, pheasants, pigeons, quail, equipment is used, no more than 2 swans, and turkeys. hours after the poultry infected with

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chlamydiosis are unloaded or the (b) After being cleaned, the premises equipment is used; must be inspected by a Federal rep- (2) Clean the items in accordance resentative, State representative, or an with part 71 of this chapter; accredited veterinarian; and (3) Have a Federal representative, (c) After being inspected, the prem- State representative, 1 or an accredited ises must be disinfected in the presence veterinarian, inspect the items after of a Federal representative, State rep- they have been cleaned; resentative, or an accredited veteri- (4) Disinfect the items in the pres- narian, in accordance with part 71 of ence of a Federal representative, State this chapter, using a disinfectant listed representative, or an accredited veteri- in part 71 of this chapter. narian; and (Approved by the Office of Management and (5) Disinfect the items in accordance Budget under control numbers 0579–0116 and with part 71 of this chapter and by 0579–0032) using a disinfectant as specified in part 71 of this chapter. § 82.23 Issuance of permits. (b) If the place where the cleaning (a) Application for the permit re- and disinfection would otherwise be required by this subpart to move vehi- quired has no facilities for cleaning and cles, cages, coops, containers, troughs, disinfecting, the items may be moved or other equipment interstate must be to a place where facilities are available in writing, and must be submitted to a for cleaning and disinfecting, provided Federal representative or State rep- a Federal representative or State representative. The application must in- resentative has determined that such clude the following: movement will not cause a risk of the (1) The applicant’s name and mailing spread of chlamydiosis. address; (c) Vehicles, cages, coops, containers, (2) The name and mailing address of troughs, and other equipment moved the person who will receive the items; interstate under this section must be (3) The addresses of both the origin accompanied by a permit obtained in and destination of the items; accordance with § 82.23, and copies of (4) The number and types of items in- the permit accompanying the vehicles, tended for interstate movement; and cages, coops, containers, troughs, and (5) The reason for the interstate other equipment interstate must be movement. submitted so that a copy is received by (b) Exceptions. This subpart does not both the State animal health official apply to the interstate movement of and the veterinarian in charge 2 for the poultry, vehicles, cages, coops, con- State of destination within 72 hours of tainers, troughs, or other equipment or the arrival of the vehicles, cages, material if the interstate movement is coops, containers, troughs, and other made by the United States Department equipment at the destination listed on of Agriculture for the purposes of re- the permit. search or diagnosis. (Approved by the Office of Management and (Approved by the Office of Management and Budget under control numbers 0579–0116 and Budget under control number 0579–0116) 0579–0032) § 82.24 Other interstate movements § 82.22 Cleaning and disinfecting and special permits. premises. (a) A special permit is required for Premises that contained poultry that the interstate movement of items were infected with chlamydiosis must whose movement interstate is re- be cleaned and disinfected in accord- stricted under this subpart in a manner ance with this section before any poul- or to a destination other than is spe- try are moved interstate onto the cifically prescribed by this subpart. A premises. special permit is required for the dis- (a) The premises must be cleaned in infection of vehicles, premises, cages, accordance with part 71 of this chapter; coops, containers, troughs, and other equipment by a method other than is 1 See footnote 3 to § 82.5. specifically prescribed by this subpart. 2 See footnote 4 to § 82.5. To apply for a special permit, contact

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the veterinarian in charge for the the permit or special permit was de- State in which the items are located. nied. The Administrator may, at his or her (b) Withdrawal. The Administrator discretion, issue special permits if he may withdraw a permit or special per- or she determines the activity author- mit, orally or in writing, if he or she ized will not increase the risk of determines the person to whom the spreading chlamydiosis interstate. permit or special permit has been (b) The special permit will list the issued is violating either this subpart name and address of the person to or some condition specified in the per- whom the special permit is issued, and mit or special permit. The Adminis- the special conditions under which the trator may withdraw the permit or spe- interstate movement, or cleaning and cial permit without advance notice if disinfection, may be carried out. he or she determines that the person to (1) For an interstate movement, the whom the permit or special permit has special permit will also include the fol- been issued is violating either this sub- lowing: part or some condition specified in the (i) The name and mailing address of permit or special permit in a way that the person who will receive the items; threatens the public health, interest, (ii) The addresses of both the origin or safety. The Administrator will send and destination of the items; the person to whom the permit or spe- (iii) The number and type of items to cial permit has been issued a written be moved interstate; and (iv) The reason for the interstate explanation of why the permit or spe- movement. cial permit is to be or was withdrawn. (2) For cleaning and disinfection, the (c) Appeals. Denial or withdrawal of a special permit will also include the fol- permit or special permit may be ap- lowing: pealed to the Administrator within 10 (i) The address of the place where the days after receipt of the written notice items are located; and of denial or withdrawal. The appeal (ii) The number and type of items in- must be in writing 3 and must state all volved. of the facts and reasons upon which the (c) For an interstate movement, a person relies to show that the permit copy of the special permit must accom- or special permit was wrongfully de- pany the items moved, and copies must nied or withdrawn. The Administrator be submitted so that a copy is received will grant or deny the appeal, in writ- by both the State animal health offi- ing, explaining all of the reasons for cial and the veterinarian in charge for the decision, as promptly as cir- the State of destination within 72 cumstances allow. In cases where there hours of the arrival of the items at the is a conflict as to any material fact, destination listed on the special per- the person denied a permit or special mit. permit, or from whom a permit or special permit is withdrawn, shall be given (Approved by the Office of Management and Budget under control number 0579–0116) an opportunity for a hearing with respect to the merits or validity of the § 82.25 Denial and withdrawal of per- denial or withdrawal in accordance mits and special permits. with rules of practice adopted for the (a) Denial. If the Administrator de- proceeding. termines that the applicant for a per- (Approved by the Office of Management and mit or special permit is not complying Budget under control number 0579–0116) with or could not comply with this subpart or any special conditions needed to prevent the spread of chlamydiosis, PART 83—VIRAL HEMORRHAGIC or, in the case of a special permit, that SEPTICEMIA the special permit is not required under this subpart, the Administrator Sec. may deny the request for a permit or 83.1 Definitions. special permit. If the request is denied, 83.2 General restrictions. the Administrator will send the applicant a written notice explaining why 3 See footnote 10 to § 82.13.

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83.3 Interstate movement of live VHS-regu- VHS-regulated fish used, or intended to lated fish species from VHS-regulated be used, as live bait. areas. Competent authority. The State, Trib- 83.4 VHS-regulated fish and VHS-regulated al, or Federal entity with the legal re- areas. 83.5 Interstate Certificate of Inspection sponsibility for ensuring or supervising (ICI). the implementation of aquatic animal 83.6 Testing requirements. health measures. 83.7 Shipping containers; cleaning and dis- Cultured fish. Fish of the same species infection. and age class, originating from the AUTHORITY: 7 U.S.C. 8301–8317; 7 CFR 2.22, same broodstock and on the same 2.80, and 371.4. water supply, whose care is partly or SOURCE: 73 FR 52184, Sept. 9, 2008, unless totally managed from the first life otherwise noted. stage onwards. Department. The United States De- EFFECTIVE DATE NOTE: At 73 FR 52184, partment of Agriculture (USDA). Sept. 9, 2008, part 83 was added, effective Nov. 10, 2008. At 73 FR 63867, Oct. 28, 2008, the Interstate. From one State into or effective date was delayed until Jan. 9, 2009. through any other State. At 74 FR 1, Jan. 2, 2009, the effective date Interstate Certificate of Inspection was delayed indefinitely. (ICI). An official document issued by an accredited veterinarian or a State, § 83.1 Definitions. Tribal, or Federal competent authority Accredited veterinarian. A veteri- in the originating State that certifies narian who is approved by the Admin- that the fish being moved interstate istrator, in accordance with part 161 of originated from a facility that has been this chapter, to perform official animal found free of VHS virus. health work of the Animal and Plant Moved (movement). Shipped, trans- Health Inspection Service specified in ported, delivered, or otherwise aided, subchapters A, B, C, and D of this chap- induced, or caused to be moved. ter; and to perform work required by Person. Any individual, corporation, cooperative State-Federal disease con- company, association, firm, partner- trol and eradication programs. ship, society, or joint stock company, Administrator. The Administrator, or other legal entity. Animal and Plant Health Inspection Secure water source. A biosecure water Service, or any person authorized to supply that does not contain pathogens act for the Administrator. or has not had the opportunity to be Anadromous fish. Fish that are born contaminated with pathogens. Bio- and spawn in freshwater, but which secure water supplies include well, spend part of their lifecycle in salt- spring, or borehole water; surface water. water that does not contain fish popu- Animal and Plant Health Inspection lations; or water that has been treated Service (APHIS). The Animal and Plant to eliminate aquatic animal pathogens. Health Inspection Service of the United State. Any of the 50 States, the Com- States Department of Agriculture. monwealth of Puerto Rico, the Com- APHIS representative. A veterinarian monwealth of the Northern Mariana Is- or other individual employed by APHIS lands, the District of Columbia, and who is authorized to perform the serv- any territories and possessions of the ices required by this part. United States. Approved laboratory. A laboratory au- State animal health official. The State thorized by a State, Tribal, or Federal official responsible for livestock, dis- competent authority for aquatic ani- ease control, and eradication programs. mal health to perform assays for the VHS-regulated area. Any State or por- detection of VHS virus. tion of a State listed in accordance Catch-and-release fishing. Fishing for with § 83.4. pleasure or for recreational purposes, VHS-regulated fish. Any fish species including tournaments, organized fish- listed in accordance with § 83.4. ing competitions, fishing derbies, or VHS virus. Any North American (type other types of contests where individ- IV) strain of viral hemorrhagic septi- uals catch, compare, and release live cemia (VHS) virus, a rhabdovirus of VHS-regulated fish. This term excludes fish.

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Viral hemorrhagic septicemia (VHS). A (c) Live VHS-regulated fish may be disease caused by infection with VHS moved interstate for research or diag- virus. nostic purposes provided that: (1) The fish are accompanied by a VS § 83.2 General restrictions. Form 1–27; Live VHS-regulated fish may not be (2) The fish are transported in sealed moved interstate from a VHS-regulated conveyances; area except in compliance with this (3) The facility that receives the fish part. meets the following conditions: (i) The facility discharges its waste § 83.3 Interstate movement of live water to a municipal sewage system VHS-regulated fish species from that includes waste water disinfection VHS-regulated areas. sufficient to neutralize any VHS virus or to either a non-discharging settling (a) Except as provided in paragraphs pond or a settling pond that disinfects, (b) through (e) of this section, live according to all applicable local, State, VHS-regulated fish, including fish and Federal regulations, sufficiently to moved to live fish markets, may only neutralize any VHS virus. be moved interstate from a VHS-regu- (ii) Offal, including carcasses, from lated area if the fish originated from a the facility is either rendered or facility that has been found free of the composted. VHS virus in accordance with § 83.6 and (4) Any water used to transport the the fish are accompanied by an Inter- fish is disposed to a municipal sewage state Certificate of Inspection (ICI) system that includes waste water dis- issued by an accredited veterinarian or infection sufficient to neutralize any a State, Tribal, or Federal competent VHS virus or to either a non-dis- authority for aquatic animal health. charging settling pond or a settling (b) Live VHS-regulated fish may be pond that disinfects, according to all moved interstate directly to a slaugh- applicable local, State, and Federal tering establishment provided that: regulations, sufficiently to neutralize (1) The fish are accompanied by a VS any VHS virus. Form 1–27; (d) Live VHS-regulated fish may be (2) The fish are transported in sealed moved interstate during catch-and-re- conveyances; lease fishing. (3) The slaughtering establishment (e) The Administrator may, on a meets the following conditions: case-by-case basis, permit the inter- (i) The slaughtering establishment state movement of fish not otherwise discharges its waste water to a munic- provided for in this part, under such ipal sewage system that includes waste conditions as the Administrator may water disinfection sufficient to neu- prescribe in each case to prevent the tralize any VHS virus or to either a introduction and dissemination of non-discharging settling pond or a set- VHS. tling pond that disinfects, according to (Approved by the Office of Management and all applicable local, State, and Federal Budget under control number 0579–0340) regulations, sufficiently to neutralize any VHS virus. § 83.4 VHS-regulated fish and VHS-reg- (ii) Offal, including carcasses, from ulated areas. the slaughtering establishment is ei- (a)(1) APHIS will list as a VHS-regu- ther rendered or composted. lated fish any fish species found in (4) Any water used to transport the freshwater to be susceptible to the fish is disposed of in a municipal sew- North American (type IV) strain of age system that includes waste water VHS virus under natural (i.e., non-con- disinfection sufficient to neutralize trolled) conditions of exposure and any VHS virus or to either a non-dis- from which VHS virus has been iso- charging settling pond or a settling lated in cell culture or other assay de- pond that disinfects, according to all termined by the Administrator to be applicable local, State, and Federal adequate to detect VHS virus, with regulations, sufficiently to neutralize confirmation of strain identity through any VHS virus. genetic sequencing. Anadromous fish

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that have migrated into freshwater and (b) The ICI must state that: from which VHS strain type IV(a) has (1) The live fish were inspected by the been isolated will not be considered accredited veterinarian or a State, VHS-regulated fish. Tribal, or Federal competent authority (2) If APHIS determines that, in ac- for aquatic animal health within 72 cordance with the criteria in paragraph hours prior to shipment, and were (a)(1) of this section, a species should found to be free of any clinical signs of be added to the list of VHS-regulated disease consistent with VHS. species, APHIS will publish a notice in (2) The live fish covered by the ICI the FEDERAL REGISTER announcing originated in an area or facility that that determination. has demonstrated freedom from VHS in (b)(1) APHIS will list as a VHS-regu- accordance with § 83.6. lated area each State or portion of a State from which VHS virus has been (c) The ICI must include the fol- detected in any VHS-regulated fish spe- lowing information: cies (with or without clinical signs of (1) The name, address, and phone disease) in a water source that is not a number of the owner or owner’s agent. secure water source, or which the Ad- (2) The name, address, and phone ministrator determines should be regu- number of the facility in which the fish lated based on criteria such as inad- originated. equate surveillance or movement re- (3) The name, address, and phone quirements, or other epidemiologic in- number of the person or facility who formation. will receive the fish; or the State or (2) If the Administrator determines other regulatory authority responsible that a State or portion of a State for oversight of the environment in meets the criteria in paragraph (b)(1) which the fish will be introduced. of this section, APHIS will publish a (4) The name, address, and phone notice of its decision in the FEDERAL number of the shipping or transpor- REGISTER and take comments from the tation company. public. The designation as a VHS-regu- (5) The species and number of the lated area will become effective upon fish. publication of this notice. After re- (6) The lot (or other) identification of viewing the comments, APHIS will the shipment. issue a second notice in the FEDERAL (7) The name, address, and phone REGISTER announcing its decision on number of the approved laboratory whether or not the designation as a that performed the testing required by VHS-regulated area will remain in ef- § 83.6. fect. (c) APHIS maintains the lists of (i) The number of fish tested; VHS-regulated fish and VHS-regulated (ii) The assay(s) used for testing; and areas on the APHIS aquaculture Web (iii) The test results. site at http://www.aphis.usda.gov/ (8) The date the certificate was animallhealth/animalldislspec/aqua- issued. culture. The lists may be obtained from (9) The type of water source accord- the Animal and Plant Health Inspec- ing to § 83.6(c). tion Service, Veterinary Services, Na- tional Aquaculture Program, 4700 River (Approved by the Office of Management and Budget under control number 0579–0340) Road Unit 46, Riverdale, MD 20737–1231. § 83.6 Testing requirements. § 83.5 Interstate Certificate of Inspec- tion (ICI). (a) A facility can demonstrate free- (a) Live VHS-regulated fish moved dom from VHS through negative test- interstate in accordance with § 83.3(a) ing results provided by an approved must be accompanied by an ICI issued laboratory. Testing must meet the fol- by an accredited veterinarian or a lowing conditions: State, Tribal, or Federal competent au- (1) Be conducted with a sample size thority for aquatic animal health. An that provides for a 95 percent con- ICI will be valid for 30 days from the fidence level of detecting a 2 percent date of issuance. prevalence of infection in the facility.

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(i) Facilities with cultured fish of (c) For VHS-regulated fish main- VHS-regulated species which can docu- tained on a secure water source, test ment a 2-year history of negative test- results will be valid for 6 months from ing for VHS virus, can conduct testing the date of sample collection provided at a sampling level to provide a 95 per- that no fish of a lesser or unknown cent confidence level of detecting a 5 health status are introduced into the percent prevalence of infection in the facility. Test results for fish held on a facility. Such testing must be con- water source that is not a secure water ducted twice a year, with at least 3 source will be valid for 30 days from months between tests. the date of sample collection. (ii) Facilities with cultured fish of VHS-regulated species which can docu- § 83.7 Shipping containers; cleaning and disinfection. ment a 4-year history of negative testing for VHS virus can conduct testing (a) All live fish that are to be moved at a sampling level to provide a 95 per- interstate in accordance with § 83.3(a) cent confidence level of detecting a 10 must be moved in new containers or in percent prevalence of infection in the containers that have been cleaned and facility. Such testing must be con- disinfected. ducted twice a year, with at least 3 (1) Cleaning and disinfection of ship- months between tests. ping containers must be monitored by (iii) Such facilities must be on a se- the accredited veterinarian or State, cure water source, and document that Tribal, or Federal competent authority any VHS-regulated species in the facil- for aquatic animal health who issues ity that originated in VHS-regulated the ICI. States or Canadian provinces originate (2) Cleaning and disinfection must be from facilities of the same or higher sufficient to neutralize any VHS virus health status. to which shipping containers may have (2) Include virus isolation or other been exposed. assays authorized by the Adminis- (3) The cleaning and disinfection pro- trator, using appropriate cell lines to tocols used must be referenced in the detect VHS virus, if present. All sus- ICI or in a separate cleaning and dis- pect VHS cytopathic effects must be infection certificate accompanying the positively identified as VHS through shipment. molecular assays and/or genetic se- (b) [Reserved] quencing. (Approved by the Office of Management and (3) Use proportional numbers of each Budget under control number 0579–0340) VHS-regulated fish species which might be present in the facility. PART 85—PSEUDORABIES (4) Be conducted at water temperatures between 50 and 72 °F, or at other Sec. times or under environmental condi- 85.1 Definitions. tions when VHS is most likely to be de- 85.2 Notice relating to the existence of the tected, if present. contagion of pseudorabies. (b) When APHIS adds a new species 85.3 General restriction. to the list of VHS-regulated species 85.4 Interstate movement of livestock. 85.5 Interstate movement of infected swine after a facility has been determined to or exposed swine. be free of VHS in accordance with para- 85.6 Interstate movement of pseudorabies graph (a) of this section, the facility vaccinate swine, except swine from must conduct additional testing on fish qualified negative gene-altered vac- of the newly listed species, if present in cinated herds, not known to be infected the facility, and the fish must be free with or exposed to pseudorabies. of VHS virus for the facility to retain 85.7 Interstate movement of swine not vac- its free status. VHS testing must be cinated for pseudorabies and not known to be infected with or exposed to conducted on each newly listed species pseudorabies. with a sample size that provides for a 85.8 Interstate movement of swine from a 95 percent confidence level of detecting qualified negative gene-altered vac- a 2 percent prevalence of infection in cinated herd. the facility. 85.9 Other interstate movements.

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85.10 Interstate movement of swine semen Approved livestock market. A stock- and swine embryos for insemination of or yard, livestock market, buying station, implantation into swine. concentration point or any other prem- 85.11 Permits and certificates. ises under State or Federal veterinary 85.12 Cleaning and disinfecting means of conveyance. supervision where swine are assembled 85.13 Cleaning and disinfecting livestock for sale or sale purposes, and which has markets and other facilities. been approved by the Administrator under § 71.20 of this chapter. 2,3 AUTHORITY: 7 U.S.C. 8301–8317; 7 CFR 2.22, 2.80, and 371.4. Certificate. An official document issued by an Animal and Plant Health SOURCE: 44 FR 10309, Feb. 16, 1979, unless Inspection Service representative, otherwise noted. State representative, or accredited vet- § 85.1 Definitions. erinarian for and prior to the interstate movement of swine that are not For purposes of this part, the fol- known to be infected with or exposed lowing terms mean: to pseudorabies, and are not Accredited veterinarian. A veteri- pseudorabies vaccinates, except for of- narian approved by the Administrator ficial gene-altered pseudorabies vac- in accordance with the provisions of cinates vaccinated with a glycoprotein part 161 of this title to perform func- I (gpI) deleted gene-altered tions specified in parts 1, 2, 3, and 11 of pseudorabies vaccine or from a quali- subchapter A, and subchapters B, C, fied negative gene-altered vaccinated and D of this chapter, and to perform herd. The document must state: (a) The functions required by cooperative number and description of the swine to state-federal disease control and eradi- be moved; (b) That the swine to be cation programs. moved are not known to be infected Administrator. The Administrator, with or exposed to pseudorabies; (c) Animal and Plant Health Inspection The purpose for which the swine are to Service, or any person authorized to be moved; (d) The points of origin and act for the Administrator. Animal and Plant Health Inspection Sevice. The Animal and Plant Health laboratory: (a) Employs personnel trained at the National Veterinary Services Labora- Inspection Service of the United States tories assigned to supervise the testing; (b) Department of Agriculture (APHIS or follows standard test protocols; (c) meets Service). check test proficiency requirements; and (d) Approved differential pseudorabies test. will report all test results to State and Fed- Any test for the diagnosis of eral animal health officials. Before the Ad- pseudorabies that: (a) Can distinguish ministrator may withdraw approval of any vaccinated swine from infected swine; laboratory for failure to meet any of these (b) Is produced under license from the conditions, the Administrator must give written notice of the proposed withdrawal to Secretary of Agriculture under the the director of the laboratory, and must give Virus-Serum-Toxin Act of March 4, the director an opportunity to respond. If 1913, and subsequent amendments (21 there are conflicts as to any material fact, a U.S.C. 151 et seq.) with indications for hearing will be held to resolve the conflict. use in the Cooperative State-Federal 2 Notices containing lists of such approved Pseudorabies Eradication Program; livestock markets are published in the FED- and (c) Is conducted in a laboratory ap- ERAL REGISTER. Information concerning live- 1 stock markets can be obtained from the Vet- proved by the Administrator. erinarian in Charge, Veterinary Services, Animal and Plant Health Inspection Service, 1 The names and addresses of laboratories United States Department of Agriculture for approved by the Administrator to conduct the State in question. approved differential pseudorabies tests are 3 Before the Administrator withdraws ap- published in the Notices Section of the FED- proval of any livestock market, the owner of ERAL REGISTER. A list of approved labora- such livestock market shall be given notice tories is also available upon request from the by the Administrator of the proposed with- Animal and Plant Health Inspection Service, drawal of approval and the reasons therefor Veterinary Services, Operational Support, and such owner shall have an opportunity to 4700 River Road Unit 33, Riverdale, Maryland present his views thereon. In those instances 20737–1231. State, Federal, and university lab- where there are conflicts as to the facts, a oratories will be approved by the Adminis- hearing shall be held to resolve such con- trator when he or she determines that the flicts.

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destination; (e) The consignor and con- Isolation. Separation of swine by a signee; and (f) Any additional informa- physical barrier in such a manner that tion required by this part. other swine do not have access to the Common ground. The ground, areas, isolated swine’s body, excrement, or buildings or equipment communally discharges; not allowing the isolated shared by any specific group or groups swine to share a building with a com- of livestock. mon ventilation system with other Contact. Direct access to other swine, swine; and not allowing the isolated their excrement, or discharges; or shar- swine to be within ten feet of other ing a building with a common ventila- swine if not sharing a building with a tion system with other swine, or being common ventilation system. within ten feet of other swine if not Known infected herd. Any herd in sharing a building with a common ventilation system. which any livestock has been deter- Exposed livestock. Any livestock that mined to be infected with pseudorabies has been in contact with an animal in- by an official pseudorabies test, an ap- fected with pseudorabies, including all proved differential pseudorabies test, livestock in a known infected herd; ex- or diagnosed by an official cept that livestock, other than swine, pseudorabies epidemiologist as having that have not been exposed to a clin- pseudorabies. ical case of the disease for a period of (a) A herd of livestock, other than 10 consecutive days shall no longer be swine, shall no longer be classified as a considered to be exposed livestock. known infected herd after 10 days since Exposed swine. Any swine that has the last clinical case of pseudorabies in been in contact with an animal in- the herd. fected with pseudorabies, including all (b) A herd of swine which has been re- swine in a known infected herd. leased from pseudorabies quarantine in Farm of origin. A farm where the accordance with the following provi- swine were born, or on which they have sions shall no longer be classified as a resided for at least 90 consecutive days known infected herd if: immediately prior to the interstate (1) All swine positive to an official shipment. pseudorabies test have been removed Feedlot. A premises where swine are from the premises; all swine which re- fed physically separated from swine kept for breeding or other purposes and main in the herd, except swine nursing from which such swine are moved di- from their mothers, are subjected to an rectly to a recognized slaughtering es- official pseudorabies serologic test and tablishment or directly through one or found negative 30 days or more after more slaughter markets and then di- removal of swine positive to an official rectly to a recognized slaughtering es- pseudorabies test; and no livestock on tablishment, quarantined herd, or the permises have shown clinical signs quarantined feedlot. of pseudorabies after removal of the Herd. Any group of livestock main- postive swine; or tained on common ground for any pur- (2) All swine have been depopulated pose, or two or more groups of live- for 30 days and the herd premises have stock under common ownership or su- been cleaned and disinfected in accord- pervision, geographically separated, ance with § 85.13; or but which have an interchange or (3) In a herd of swine in which swine movement of animals without regard are positive to an official pseudorabies to whether the animals are infected serologic test but no swine are postive with or exposed to pseudorabies. at titers greater than 1:8, all titered Infected livestock. Any livestock de- swine are subjected to another official termined to be infected with pseudorabies serologic test and found pseudorabies by an official negative; and all other swine in the pseudorabies test, or diagnosed by an official pseudorabies epidemiologist as herd which an epidemiologist, approved having pseudorabies. by the State animal health official and Interstate. From any State into or the Veterinarian in Charge, requires to through any other State. be subjected to an official pseudorabies

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serologic test are tested and found neg- swine may be retested with an ap- ative. 4 proved differential test within 30 days (4) In a herd of swine containing offi- of the initial test if they are isolated cial gene-altered pseudorabies vac- from the remainder of the herd until cinates: the retest shows them to be negative. (i) All vaccinates have been vac- Livestock. Swine, cattle, sheep or cinated with the same official gene-al- goats. tered pseudorabies vaccine; and Moved. Shipped, transported, or oth- (ii) All swine positive to an approved erwise moved, or delivered or received differential pseudorabies test have for movement by land, water, or air. been gone from the herd for at least 60 Official gene-altered pseudorabies vac- days; and cinate. Swine vaccinated with an offi- (iii) No livestock on the same prem- cial gene-altered pseudorabies vaccine, ises as the herd have shown clinical in accordance with directions on the signs of pseudorabies since removal of label. the positive swine; and Official gene-altered pseudorabies vac- (iv) The herd has been tested for cine. Any official pseudorabies vaccine pseudorabies and found negative in ac- for which there is an approved differen- cordance with one of the following two tial pseudorabies test. provisions: (A) All swine in the herd, except Official pseudorabies epidemiologist. A suckling swine, are tested with an ap- state or federally employed veteri- proved differential pseudorabies test. If narian designated by the State animal all tested swine are found negative, no health official and the veterinarian in further testing is required. If any swine charge to investigate and diagnose test positive, they may be retested pseudorabies in livestock. with an approved differential Official pseudorabies serologic test. An pseudorabies test within 30 days of the official pseudorabies test, as defined in first test if they are isolated from the this section, conducted on swine serum remainder of the herd until the retest to detect the presence or absence of shows them to be negative. pseudorabies antibodies. (B) All swine in the herd over 6 Official pseudorabies test. Any test for months of age and a random sample of the diagnosis of pseudorabies approved 30 or more swine in each segregated by the Administrator conducted in a group of swine in the herd between 2 laboratory approved by the Adminis- and 6 months of age are tested with an trator as listed in a Veterinary Serv- approved differential pseudorabies test. ices Notice listing such laboratories. 5 Not less than 30 days nor more than 60 The following tests for the diagnosis of days after this first test, another ran- pseudorabies have been approved by dom sample of 30 or more swine in each the Administrator: 1. Microtitration segregated group of swine in the herd Serum-Virus Neutralization Test; 2. between 2 and 6 months of age is tested Virus Isolation and Identification Test; with an approved differential 3. Fluorescent Antibody Tissue Section pseudorabies test. If all swine are nega- Test; 4. Enzyme-Linked tive on these tests, no further testing Immunosorbent Assay (ELISA) Test, is required. If any swine test positive except for approved differential on either of these tests, the positive pseudorabies tests other than the glycoprotein I (gpI) ELISA test; 5. 4 The epidemiologist shall consider the fol- Latex Agglutination Test (LAT); and 6. lowing epidemiologic evidence to determine Particle Concentration Fluorescence which swine in the herd, in addition to the Immunoassay (PCFIA) Test, including titered swine, must be subjected to an official pseudorbies serologic test and found negative: (a) the percentage and number of 5 Notices containing lists of laboratories titered swine in the herd; (b) the number of approved for the purposes of the regulations titered swine as compared to the number of in this part are published in the FEDERAL swine tested; (c) the extent of the contact of REGISTER Notices Section. The lists are also members of the herd with the titered swine; available upon request from the Animal and (d) the prevalence of pseudorabies in the Plant Health Inspection Service, Veterinary area; (e) the herd management practices; and Services, Operational Support, 4700 River (f) any other reliable epidemiologic evidence. Road Unit 33, Riverdale, Maryland 20737–1231.

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the gpI PCFIA test. 6 State, Federal, to be moved; (b) the points of origin and University laboratories will be ap- and destination; (c) the consignor and proved by the Administrator following consignee; and (d) any additional infor- the determination by him that the lab- mation required by this part. oratory: (a) Has personnel trained at Permit. An official document issued the Veterinary Services Diagnostic for and prior to the interstate move- Laboratory, Ames, Iowa, assigned to ment of pseudorabies infected, exposed supervise the test, (b) follows standard or vaccinated swine under this part by test protocol, (c) meets check test pro- an Animal and Plant Health Inspection ficiency requirements, and (d) will re- Service representative, State rep- port all test results to State and Fed- resentative, or an accredited veteri- eral animal health officials. 7 narian which states: (a) The number of Official pseudorabies vaccine. Any swine to be moved; (b) the purpose for pseudorabies virus vaccine produced which the swine are to be moved; (c) under license from the Secretary of Ag- the points of origin and destination; (d) riculture under the Virus, Serum and the consignor and the consignee; and Toxin Act of March 4, 1913, and any leg- (e) any additional information required islation amendatory thereof (21 U.S.C. by this part. 151 et seq.). Pseudorabies. The contagious, infec- Official vaccinate. Any swine which tious, and communicable disease of have been: (a) Vaccinated with an offi- livestock and other animals also cial pseudorabies vaccine by an accred- known as Aujeszky’s disease, mad itch, ited veterinarian or a State or Federal or infectious bulbar paralysis. veterinarian in accordance with rec- Pseudorabies controlled vaccinated ommendations on the vaccine label and herd. (a) Pseudorabies controlled vac- the laws and regulations of the State cinated herd status is attained by sub- in which the swine are vaccinated; (b) jecting all swine over 6 months of age identified by a numbered pink eartag to an official pseudorabies serologic approved by the State in which such test and finding all swine so tested neg- 8 swine are vaccinated; and (c) reported ative. The herd must not have been a as official vaccinates at the time of known infected herd within the past 30 vaccination to the State animal health days. Any swine in the herd over 6 official. months of age may be vaccinated for Owner-shipper statement. A statement pseudorabies within 15 days after being signed by the owner or shipper of swine subjected to an official pseudorabies which states: (a) The number of swine serologic test and found negative. 1 (b) If on the qualifying official 6 Copies of the test protocols (Rec- pseudorabies serologic test or any sub- ommended Minimum Standards for Diag- sequent official pseudorabies test, any nostic Tests Employed in the Diagnosis of Pseudorabies (Aujeszky’s Disease)) published swine so tested are positive, as a Veterinary Services Notice, May 17, pseudorabies controlled vaccinated 1978, are available upon request from the herd status is attained or regained by: Animal and Plant Health Inspection Service, removing all positive swine; cleaning Veterinary Services, Operational Support, and disinfecting the herd premises in 4700 River Road, Unit 33, Riverdale, Mary- accordance with § 85.13; subjecting all land 20737–1231. swine in the herd, except swine nursing 7 Before the Administrator withdraws the from their mothers, to an official approval of any laboratory, the Director of such laboratory shall be given a notice by pseudorabies serologic test 30 days or the Administrator of the proposed dis- more after removal of the positive approval and the reasons therefore and such swine and finding all swine so tested Director shall have an opportunity to negative; and, after an interval of 30 to present his views thereon. In those instances 60 days after the first such negative of- where there are conflicts as to the facts, a ficial pseudorabies serologic herd test, hearing shall be held to resolve such con- subjecting all swine in the herd over 6 flicts. months of age to another official 8 The numbered pink eartags are available commercially. Should any problem arise re- pseudorabies serologic test and finding garding the availability of such eartags, con- all swine so tested negative. tact the appropriate State animal health of- (c)(1) Pseudorabies controlled vac- ficial. cinated herd status is maintained by:

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subjecting 25 percent of all the off- exposed to pseudorabies, and in which spring to an official pseudorabies sero- no swine are vaccinated for logic test when they are between 16 and pseudorabies, may achieve status as a 20 weeks of age and finding all swine so qualified negative gene-altered vac- tested negative, or by leaving 10 per- cinated herd under the following condi- cent of the swine over 6 months of age tions: in the herd unvaccinated and sub- (1) All swine in the herd over 6 jecting all such unvaccinated swine to months of age must be tested with an an official pseudorabies serologic test official pseudorabies serologic test. For every 80–105 days and finding all swine a minimum of 30 days before the test, so tested negative. the herd must not have been a known (2) Any swine in the herd over 6 infected herd. During the 90 days before months of age may be vaccinated for the test, at least 90 percent of the pseudorabies within 15 days after being swine in the herd either must have subjected to an official pseudorabies been on the premises and a part of the serologic test and found negative; Pro- herd, or must have entered the herd divided That, if pseudorabies controlled rectly from a qualified pseudorabies vaccinated herd status is to be main- negative herd. If any of the tested tained by testing unvaccinated swine swine are found positive on this or any over 6 months of age, at least 10 per- other official pseudorabies test prior to cent of the swine in the herd over 6 vaccination with the official gene-al- months of age shall remain tered pseudorabies vaccine, the re- unvaccinated. quirements in paragraph (a)(2) must be (3) All swine intended to be added to met. a pseudorabies controlled vaccinated (2) All swine that are positive on an herd shall be isolated until the swine official pseudorabies test must be re- have been found negative to an official moved from the herd, or must be iso- pseudorabies serologic test conducted lated until another official 30 days or more after the swine have pseudorabies test conducted within 30 been placed in isolation. Not more than days of the first test shows them to be 90 percent of the swine over 6 months negative. If the results of the second of age added to the herd may be vac- test are negative, no additional testing cinated for pseudorabies. All additions is required before the herd may be vac- to the herd which are to be vaccinated cinated in accordance with paragraph for pseudorabies shall be vaccinated (a)(3). If the results of the second test within 15 days after being subjected to are positive, all swine that tested posi- such official pseudorabies serologic tive must be removed from the herd. test. All additions to the herd shall be Not less than 30 days after any positive added to the herd within 30 days after swine are removed from the herd, all such official pseudorabies serologic remaining swine in the herd, except test. suckling swine, must be tested with an (4) Swine which have not been vac- official pseudorabies serologic test and cinated for pseudorabies and which are found negative. Not less than 30 days to be tested to maintain pseudorabies after this negative test, the herd must controlled vaccinated herd status shall be tested again in accordance with be maintained in the herd so that the paragraph (a)(1). pseudorabies vaccinates can physically (3) Not more than 30 days after test touch nonvaccinates or so that the results show the herd to be negative for pseudorabies vaccinates are within 10 pseudorabies in accordance with para- feet of nonvaccinates while sharing a graph (a)(1), all swine in the herd over direct common ventilation system with 6 months of age must be vaccinated such nonvaccinates. with an official gene-altered Pseudorabies vaccinate. Any swine pseudorabies vaccine. Only one official that have been vaccinated with any gene-altered pseudorabies vaccine may product containing antigens for be used in the herd. pseudorabies. (b) Any herd designated as a qualified Qualified negative gene-altered vac- pseudorabies negative herd may cinated herd. (a) Any herd in which no achieve new status as a qualified nega- swine are known to be infected with or tive gene-altered vaccinated herd if all

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swine in the herd over 6 months of age official gene-altered pseudorabies vac- are vaccinated with an official gene-al- cinates must be vaccinated with an of- tered pseudorabies vaccine. Only one ficial gene-altered pseudorabies vac- official gene-altered pseudorabies vaccine. Only one official gene-altered cine may be used in the herd. pseudorabies vaccine may be used in (c) Any herd in which no swine are the herd. known to be infected with or exposed (d) Qualified negative gene-altered to pseudorabies, and in which the only vaccinated herd status is maintained swine vaccinated for pseudorabies are under the following conditions: official gene-altered pseudorabies vac- (1) All swine over 6 months of age in cinates, may achieve status as a quali- the herd must be official gene-altered fied negative gene-altered vaccinated pseudorabies vaccinates, and only one herd under the following conditions: official gene-altered pseudorabies vac- (1) Only one official gene-altered cine may be used in the herd. pseudorabies vaccine may be used in (2) All swine over 6 months of age in the herd. the herd must be tested at least once a (2) All swine in the herd over 6 year with an approved differential months of age must be tested with an pseudorabies test and found negative; approved differential pseudorabies test. except that, if any swine are positive, For a minimum of 60 days before the the herd may maintain its status if the test, the herd must not have been a positive swine are isolated from the known infected herd. During the 90 rest of the herd until they are found days before the test, at least 90 percent negative to a second approved differen- of the swine in the herd either must tial pseudorabies test conducted within have been on the premises and a part of 30 days of the first. The requirement the herd or must have entered the herd for annual testing of all swine in the directly from a qualified pseudorabies herd over 6 months of age may be met negative herd or a qualified negative by testing 25 percent of the swine over gene-altered vaccinated herd. If any of 6 months of age every 80–105 days, or by the tested swine are found positive on testing 10 percent of the swine over 6 this test, the requirements in para- months of age each month. No swine graph (c)(3) must be met. may be tested twice in 1 year to com- (3) All swine positive on an approved ply with the 25 percent requirement, or differential pseudorabies test must be twice in 10 months to comply with the removed from the herd, or must be iso- 10 percent requirement. lated until another approved differen- (3) Swine may be added to a qualified tial pseudorabies test conducted within negative gene-altered vaccinated herd 30 days of the first test shows them to only under one of the following condi- be negative. If the results of the second tions: test are negative, no additional testing (i) The swine are moved to the quali- is required before the herd may be vac- fied negative gene-altered vaccinated cinated in accordance with paragraph herd from another qualified negative (c)(4). If the results of the second test gene-altered vaccinated herd, or from a are positive, all swine that tested posi- qualified pseudorabies negative herd, tive must be removed from the herd. without having any contact en route No less than 30 days after any negative with swine other than those from a swine are removed from the herd, all qualified negative gene-altered vac- remaining swine in the herd, except cinated herd or a qualified suckling swine, must be tested with an pseudorabies negative herd. approved differential pseudorabies test (ii) The swine are moved to the quali- and found negative. No less than 30 fied negative gene-altered vaccinated days after this negative test, the herd herd from a qualified pseudorabies neg- must be tested again in accordance ative herd, have contact en route with with paragraph (c)(2). swine other than those from a qualified (4) No more than 30 days after test re- negative gene-altered vaccinated herd sults show the herd to be negative for or a qualified pseudorabies negative pseudorabies in accordance with para- herd, and, before being added, are iso- graph (c)(2), all swine in the herd over lated until they are found negative to 6 months of age that are not already an official pseudorabies serologic test

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conducted 30 days or more after the subjecting all swine in the herd over 6 swine are isolated. months of age to another official (iii) The swine are moved to the pseudorabies serologic test and finding qualified negative gene-altered vac- all swine so tested negative; or cinated herd from another qualified (2) If on any qualifying official negative gene-altered vaccinated herd, pseudorabies serologic test or any sub- have contact en route with swine other sequent official pseudorabies serologic than those from a qualified negative test, any swine so tested are positive, gene-altered vaccinated herd or a but no swine are positive at titers qualified pseudorabies negative herd, greater than 1:8, qualified pseudorabies and, before being added, are isolated negative herd status is attained or re- until they are found negative to an ap- gained by: Subjecting all titered swine proved differential pseudorabies test and all other swine required to be test- conducted 30 days or more after the ed by an epidemiologist, approved by swine are isolated. the State animal health official and (iv) The swine are removed to the the Veterinarian in Charge, to an offi- qualified negative gene-altered vac- cial pseudorabies serologic test and cinated herd from a herd other than a finding all such swine negative. 1 qualified negative gene-altered vac- (c) Qualified pseudorabies negative cinated herd or a qualified herd status is maintained by subjecting pseudorabies negative herd, and, before all swine over 6 months of age in the being added, are isolated until they are herd to an official pseudorabies sero- found negative to two official logic test at least once each year (this pseudorabies serologic tests, one con- must be accomplished by testing 25 ducted at the time the swine are iso- percent of swine over 6 months of age lated, and the second conducted 30 days every 80–105 days and finding all swine or more after the swine are isolated. so tested negative, or by testing 10 per- Qualified pseudorabies negative herd. cent of the swine over 6 months of age (a) Qualified pseudorabies negative each month and finding all swine so herd status is attained by subjecting tested negative; no swine shall be test- all swine over 6 months of age to an of- ed twice in 1 year to comply with the ficial pseudorabies serologic test and 25 percent requirement or twice in 10 finding all swine so tested negative. months to comply with the 10 percent The herd must not have been a known requirement). All swine intended to be infected herd within the past 30 days. A added to a qualified pseudorabies nega- minimum of 90 percent of the swine in tive herd shall be isolated until the the herd must have been on the prem- swine have been found negative to two ises and a part of the herd for at least official pseudorabies serologic tests, 90 days prior to the qualifying official one conducted 30 days or more after pseudorabies serologic test or have en- the swine have been placed in isolation, tered directly from another qualified the second test being conducted 30 days pseudorabies negative herd. or more after the first test; except (1) (b)(1) If on a qualifying official swine intended to be added to a quali- pseudorabies serologic test or any sub- fied pseudorabies negative herd di- sequent official pseudorabies test, any rectly from another qualified swine so tested are positive, qualified pseudorabies negative herd may be pseudorabies negative herd status is at- added without isolation or testing; (2) tained or regained by: Removing all swine intended to be added to a quali- positive swine and cleaning and dis- fied pseudorabies negative herd from infecting the herd premises in accord- another qualified pseudorabies nega- ance with § 85.13; subjecting all swine in tive herd, but with interim contact the herd, except swine nursing from with swine other than those from a sin- their mothers, to an official gle qualified pseudorabies negative pseudorabies serologic test 30 days or herd, shall be isolated until the swine more after removal of the positive have been found negative to an official swine and finding all swine so tested pseudorabies serologic test, conducted negative; and, after an interval of 30 to 30 days or more after the swine have 60 days after the first such negative of- been placed in isolation; (3) swine re- ficial pseudorabies serologic herd test, turned to the herd after contact with

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swine other than those from a single before being used for feeding or breed- qualified pseudorabies negative herd ing swine.9,10 shall be isolated until the swine have State. Any State or Territory of the been found negative to an official United States, the District of Colum- pseudorabies serologic test conducted bia, Puerto Rico, Guam or the North- 30 days or more after the swine have ern Mariana Islands. been placed in isolation. State animal health official. The State animal health official who is respon- Quarantined feedlot. A premises where sible for the livestock and poultry dis- pseudorabies infected or exposed swine ease control and eradication programs are fed under the supervision and con- in the official’s State or his designated trol of the State animal health official, representative. and from which such swine are moved State representative. A person regu- directly to a recognized slaughtering larly employed in animal health work establishment or directly through one of a State and who is authorized by or more slaughter markets and then di- such State to perform the function in- rectly to a recognized slaughtering es- volved under a Cooperative Agreement tablishment in accordance with the with the United States Department of provisions of this part. Agriculture. Quarantined herd. A herd in which Swine not known to be infected with or pseudorabies infected or exposed swine exposed to pseudorabies. Any swine from are bred, reared, and fed under the su- a herd of swine in which no animal has pervision and control of the State ani- been classified as a reactor to an offi- mal health official, and from which cial pseudorabies test, or has been di- such swine are moved interstate diagnosed as having pseudorabies or sus- rectly to a recognized slaughtering es- pected of having pseudorabies by a vet- tablishment or directly through one or erinarian; or any swine from a herd of more slaughter markets and then di- swine which has been released from rectly to a recognized slaughtering es- quarantine or has met the requirements of release from quarantine in ac- tablishment, or from which exposed of- cordance with the definition of known ficially vaccinated swine which were infected herd in § 85.1. negative to an official pseudorabies se- Veterinarian in charge. The veterinary rologic test may be moved only to a official of Veterinary Services, Animal quarantined herd or quarantined feed- and Plant Health Inspection Service, lot. United States Department of Agri- Recognized slaughtering establishment. culture, who is assigned by the Admin- A slaughtering establishment operated istrator to supervise and perform offi- under the provisions of the Federal cial animal health work of the Animal Meat Inspection Act (21 U.S.C. 601 et and Plant Health Inspection Service in seq.) or a State inspected slaughtering the State concerned. establishment. Slaughter market. A livestock market 9 Notices containing lists of slaughter mar- approved in accordance with § 71.20 of kets approved for the purposes of the regula- this chapter, at which swine for sale tions in this part are published in the FED- and shipment for slaughter are handled ERAL REGISTER. Information concerning slaughter markets can be obtained from the only on days when no swine are han- Veterinarian in Charge, Veterinary Services, dled for sale and shipment for feeding Animal and Plant Health Inspection Service, or breeding purposes unless facilities U.S. Department of Agriculture, for the are provided to keep slaughter swine State in question. physically separated from feeder and 10 Before the Administrator withdraws ap- breeder swine, and feeder and breeder proval of any slaughter market, the owner of such slaughter market shall be given notice swine use no facilities previously used by the Administrator of the proposed with- by slaughter swine on the day these drawal of approval and the reasons therefore classes of swine are at the market. The and such owner shall have an opportunity to facilities used by slaughter swine shall present his views thereon. In those instances be cleaned and disinfected in accord- where there are conflicts as to the facts, a hearing shall be held to resolve such con- ance with the requirements of this part flicts.

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Veterinary Services. Veterinary Serv- § 85.5 Interstate movement of infected ices, Animal and Plant Health Inspec- swine or exposed swine. tion Service, United States Depart- Infected swine or exposed swine, ment of Agriculture. other than swine described in § 85.4 (a) Veterinary Services representative. A or (b), shall only be moved interstate person employed by Veterinary Serv- in accordance with the following provi- ices, Animal and Plant Health Inspec- sions: tion Service, United States Depart- (a) Movement of infected or exposed ment of Agriculture, who is authorized swine for slaughter. Infected or exposed to perform the function involved. swine shall be moved interstate for (Approved by the Office of Management and slaughter only if: Budget under control number 0579–0069) (1) The swine are moved directly to a recognized slaughtering establishment [44 FR 10309, Feb. 16, 1979] or directly through one or more EDITORIAL NOTE: For FEDERAL REGISTER ci- slaughter markets and then directly to tations affecting § 85.1, see the List of CFR a recognized slaughtering establish- Sections Affected, which appears in the ment; Finding Aids section of the printed volume (2) The swine are accompanied by a and at www.fdsys.gov. permit or owner-shipper statement and such permit or owner-shipper state- § 85.2 Notice relating to the existence ment is delivered to the consignee; of the contagion of pseudorabies. (3) The permit, in addition to the in- Notice is hereby given that there is formation in § 85.1, or the owner-ship- reason to believe that the contagion of per statement, in addition to the infor- pseudorabies may exist in each State mation in § 85.1, lists the identification and that to prevent the spread and dis- of the swine as required by § 71.19 of semination of the contagion thereof, this chapter; except if the swine are and to protect the livestock of the moved interstate and the indentity of United States, the regulations in this the farm of origin of each swine is part are promulgated. maintained, the permit or the owner- shipper statement need not list the § 85.3 General restriction. identification required by § 71.19 of this Livestock shall not be moved inter- chapter, if such swine are identified to state except in compliance with the the farm of orgin at the recognized regulations in this part. slaughtering establishment or the first slaughter market; and § 85.4 Interstate movement of live- (4) The swine are moved to destina- stock. tion in one continuous movement with- (a) Livestock showing clinical evi- out unloading enroute. dence of pseudorabies shall not be (b) Movement of exposed swine to a moved interstate. quarantined herd or a quarantined feed- (b) Livestock that have been exposed lot. Exposed swine shall be moved to an animal showing clinical evidence interstate directly to a quarantined of pseudorabies shall not be moved herd or quarantined feedlot only if: interstate within 10 days of such expo- (1) The swine are negative to an offi- sure. cial pseudorabies serologic test 21 days (c) Except as provided in paragraphs or more after last being exposed to any (a) and (b) of this section, livestock livestock showing clinical evidence of other than swine may be moved inter- pseudorabies; (2) The swine are officially vac- state without restriction under this cinated for pseudorabies within 15 days part. after the negative test; (d) Except as provided in paragraphs (3) The swine are moved interstate (a) and (b) of this section, swine, swine within 30 days after the negative test; semen, and swine embryos shall be (4) The swine are accompanied by a moved interstate only in compliance permit and such permit is delivered to with the regulations in this part. the consignee; and [44 FR 10309, Feb. 16, 1979, as amended at 50 (5) The permit, in addition to the in- FR 47352, Nov. 15, 1985] formation described in § 85.1, states: (i)

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The present pseudorabies quarantine Pseudorabies vaccinate swine, except status of the farm of origin; (ii) the swine from qualified negative gene-al- identification of the swine as required tered vaccinated herds, not known to by § 71.19 of this chapter; (iii) the date be infected with or exposed to of the official pseudorabies serologic pseudorabies shall be moved interstate test and the name of the laboratory directly to a quarantined herd or quar- where the test was conducted; (iv) the antined feedlot only if: date of the official vaccination for (1) The swine are accompanied by a pseudorabies; and (v) that approval for permit and such permit is delivered to the interstate movement has been the consignee; and issued by the State animal health offi- (2) The permit in addition to infor- cial of the State of destination prior to the interstate movement of the swine. mation described in § 85.1 states: (i) The pseudorabies status of the herd; (ii) the (Approved by the Office of Management and identification of the swine required by Budget under control number 0579–0051) § 71.19 of this chapter; (iii) the date of [44 FR 10309, Feb. 16, 1979, as amended at 48 the vaccination for pseudorabies; and FR 57472, Dec. 30, 1983; 50 FR 47352, Nov. 15, (iv) that approval for the interstate 1985; 53 FR 40387, Oct. 14, 1988; 59 FR 67133, movement has been issued by the State Dec. 29, 1994] animal health official of the State of § 85.6 Interstate movement of destination prior to the interstate pseudorabies vaccinate swine, ex- movement of the swine. cept swine from qualified negative (c) General movements. Swine vac- gene-altered vaccinated herds, not cinated for pseudorabies with a known to be infected with or ex- glycoprotein I (gpI) deleted gene-al- posed to pseudorabies. tered pseudorabies vaccine and not Pseudorabies vaccinate swine, except known to be infected with or exposed swine from qualified negative gene-al- to pseudorabies, but that are not from tered vaccinated herds, not known to a qualified negative gene-altered vac- be infected with or exposed to cinated herd, may be moved interstate pseudorabies shall only be moved inter- to destinations other than those set state in accordance with the following forth in paragraphs (a) and (b) of this provisions: section only if: (a) Movement of pseudorabies vaccinate swine, except swine from qualified nega- (1) The swine are accompanied by a tive gene-altered vaccinated herds, for certificate and such certificate is deliv- slaughter. Pseudorabies vaccinate ered to the consignee; and swine, except swine from qualified neg- (2) The certificate, in addition to the ative gene-altered vaccinated herds, information described in § 85.1, states: not known to be infected with or ex- (i) The identification required by posed to pseudorabies shall be moved § 71.19 of this chapter; interstate for slaughter only if: (ii) That each animal to be moved (1) The swine are moved directly to a was vaccinated for pseudorabies with a recognized slaughtering establishment gpI-deleted gene-altered pseudorabies or directly through one or more vaccine; slaughter markets and then directly to (iii) That each animal to be moved a recognized slaughtering establish- was subjected to a gpI enzyme-linked ment; immunosorbent assay (ELISA) or a gpI (2) The swine are accompanied by a Particle Concentration Fluorescence permit or owner-shipper statement and Immunoassay (PCFIA) approved dif- such permit or owner-shipper state- ferential pseudorabies test no more ment is delivered to the consignee; and than 30 days prior to the interstate (3) The swine are moved to destination in one continuous movement with- movement and was found negative; out unloading enroute. (iv) The date of the gpI ELISA or the (b) Movement of pseudorabies vaccinate gpI PCFIA approved differential swine, except swine from qualified nega- pseudorabies test; and tive gene-altered vaccinated herds, to a (v) The name of the laboratory that quarantined herd or quarantined feedlot. conducted the gpI ELISA or the gpI

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PCFIA approved differential nition of known infected herd in § 85.1, pseudorabies test. and (i) Unless the swine are moving inter- (Approved by the Office of Management and Budget under control number 0579–0051) state in a swine production system in compliance with § 71.19(g) of this chap- [44 FR 10309, Feb. 16, 1979, as amended at 48 ter, the swine are accompanied by an FR 57472, Dec. 30, 1983; 50 FR 47352, Nov. 15, owner-shipper statement and are 1985; 53 FR 40387, Oct. 14, 1988; 55 FR 19253, May 9, 1990; 59 FR 67133, Dec. 29, 1994; 60 FR moved from a farm of origin directly to 26355, May 17, 1995; 63 FR 17316, Apr. 9, 1998] an approved livestock market; and (A) The owner-shipper statement is § 85.7 Interstate movement of swine delivered to the consignee, and not vaccinated for pseudorabies (B) The swine are identified at the and not known to be infected with approved livestock market to the farm or exposed to pseudorabies. of origin by the identification required Swine not vaccinated for/ by § 71.19 of this chapter. pseudorabies and not known to be in- (ii) Unless the swine are moving fected with or exposed to pseudorabies interstate in a swine production sys- shall only be moved interstate in ac- tem in compliance with § 71.19(g) of this cordance with the following provisions: chapter, the swine are accompanied by (a) Movement for slaughter. Swine not a certificate and such certificate is de- vaccinated for pseudorabies and not livered to the consignee; the certifi- known to be infected with or exposed cate, in addition to the information in to pseudorabies may be moved inter- § 85.1, states the identification of the state for slaughter without further re- farm of origin of each swine being striction under this part directly to a moved by a means of identification re- recognized slaughtering establishment quired by § 71.19 of this chapter, and ap- or directly through one or more proval for the interstate movement has slaughter markets and then directly to been issued by the State animal health a recognized slaughtering establish- official of the State of destination ment. prior to the interstate movement of (b) Movement to a feedlot, quarantined the swine, and feedlot, quarantined herd, or approved (A) The swine are moved directly to a livestock market. Swine not vaccinated feedlot, quarantined feedlot, quar- for pseudorabies and not known to be antined herd or approved livestock infected with or exposed to market from a farm of origin; or pseudorabies may be moved interstate (B) The swine are moved directly to a only if: feedlot, quarantined feedlot, quar- (1) The swine are moved from a quali- antined herd or approved livestock fied pseudorabies negative herd di- market from an approved livestock rectly to a feedlot, quarantined feedlot, market which received the swine di- quarantined herd, or approved live- rectly from a farm of origin, or stock market; or (C) The swine are moved directly to a (2) The swine are moved directly to a feedlot, quarantined feedlot, or quar- feedlot, quarantined feedlot, quarantined herd from an approved live- antined herd, or to an approved livestock market, which received the swine stock market for subsequent move- from another approved livestock mar- ment to a feedlot or quarantined feed- ket, which received the swine directly lot, quarantined herd in accordance from a farm of origin. with paragraph (c) of this section; or (c) General movements. Swine not vac- (3) The swine are moved from a State cinated for pseudorabies and not which requires the State animal health known to be infected with or exposed official of that State to be immediately to pseudorabies may be moved inter- notified of any suspected or confirmed state only if: case of pseudorabies in that State and (1) Unless the swine are moving which requires that exposed or infected interstate in a swine production sys- livestock be quarantined, such quar- tem in compliance with § 71.19(g) of this antine to be released only after having chapter, the swine are accompanied by met quarantine release standards no a certificate and such certificate is de- less restrictive than those in the defi- livered to the consignee; and

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(2) The certificate, in addition to the certificate must be delivered to the information described in § 85.1, states: consignee. In addition to the informa- (i) The identification required by § 71.19 tion required by § 85.1 of this part, the of this chapter; and (ii) that each ani- certificate must state: (1) That the mal to be moved: (A) Was subjected to swine are from a qualified negative an official pseudorabies serologic test gene-altered vaccinated herd; (2) The within 30 days prior to the interstate date of the herd’s last qualifying test; movement and was found negative, the (3) The identification for the swine to test date and the name of the labora- be moved interstate, in accordance tory conducting the test; or (B) is part with § 71.19 of this chapter; and (4) If of a currently recognized qualified the swine to be moved are official gene- pseudorabies negative herd and the altered pseudorabies vaccinates, the of- date of the last qualifying test; or, (C) ficial gene-altered pseudorabies vac- is part of a pseudorabies controlled cine used in the herd. vaccinated herd and is one of the off- [55 FR 19253, May 9, 1990, as amended at 66 spring that was subjected to the offi- FR 65604, Dec. 20, 2001; 69 FR 64651, Nov. 8, cial pseudorabies serologic test to 2004] achieve or maintain the status of the herd as a pseudorabies controlled vac- § 85.9 Other interstate movements. cinated herd, and the date of the last The Administrator may, upon retest to maintain said status. quest in specific cases, permit the (Approved by the Office of Management and interstate movement of livestock not Budget under control number 0579–0069) otherwise provided for in this part under such conditions as he may pre- [44 FR 10309, Feb. 16, 1979, as amended at 48 scribe to prevent the spread of FR 57472, Dec. 30, 1983; 50 FR 47352, Nov. 15, 1985; 53 FR 40387, Oct. 14, 1988; 66 FR 65604, pseudorabies. The Animal and Plant Dec. 20, 2001; 69 FR 64651, Nov. 8, 2004] Health Inspection Service intends that such authority be used only in situa- § 85.8 Interstate movement of swine tions and under circumstances pre- from a qualified negative gene-al- senting problems that could not have tered vaccinated herd. been reasonably anticipated in advance Swine from a qualified negative gene- and in unique situations. The Animal altered vaccinated herd, and not known and Plant Health Inspection Service to be infected with or exposed to does not intend that such authority be pseudorabies, may be moved inter- used repeatedly to cover the same estate only in accordance with the fol- problem, but that the regulation be lowing provisions: amended to conform with needed (a) Without further restriction under changes as they come to light. this part if: [44 FR 10309, Feb. 16, 1979, as amended at 54 (1) The swine are moved directly to a FR 21049, May 16, 1989. Redesignated at 55 FR recognized slaughtering establishment, 19253, May 9, 1990] or directly through one or more slaughter markets and then directly to § 85.10 Interstate movement of swine a recognized slaughtering establish- semen and swine embryos for in- ment; or semination of or implantation into (2) The swine are moved directly to a swine. feedlot, quarantined feedlot, or ap- Swine semen and swine embryos proved livestock market; or moved interstate for insemination of (3) The swine are moved from an ap- swine or implantation into swine shall proved livestock market to a feedlot, be accompanied by a document issued quarantined feedlot, or other approved by an accredited veterinarian stating livestock market; or that the donor swine are not known to (4) The swine are moved interstate in be infected with or exposed to a swine production system in compli- pseudorabies, were negative to an offi- ance with § 71.19(g) of this chapter. cial pseudorabies serologic test within (b) For all interstate movements 30 days prior to the collection of the other than those set forth in paragraph semen or embryos or were members of (a) of this section, the swine must be a qualified pseudorabies negative herd, accompanied by a certificate, and the and had not been exposed to

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pseudorabies within 30 days prior to Rodenticide Act, as amended (7 U.S.C. the collection of the semen or embryos. 135 et seq.) with herpes virucidal claims. These disinfectants shall be used in ac- (Approved by the Office of Management and Budget under control number 0579–0032) cordance with directions on their labels accepted in connection with their [44 FR 10309, Feb. 16, 1979, as amended at 50 registration. FR 47353, Nov. 15, 1985. Redesignated at 55 FR 19253, May 9, 1990; 59 FR 67133, Dec. 29, 1994] [44 FR 10309, Feb. 16, 1979, as amended at 62 FR 27937, May 22, 1997] § 85.11 Permits and certificates. (a) Each permit, certificate or owner- PART 88—COMMERCIAL TRANS- shipper statement required under this PORTATION OF EQUINES FOR part to accompany swine interstate SLAUGHTER shall be delivered with the swine to the consignee by the person delivering the Sec. swine. 88.1 Definitions. (b) A copy of each permit or certifi- 88.2 General information. cate required under this part to accom- 88.3 Standards for conveyances. pany swine interstate shall be mailed 88.4 Requirements for transport. or delivered to the State animal health 88.5 Requirements at a slaughtering facility. official of the State of destination by 88.6 Violations and penalties. the person issuing the document within 3 days of the interstate movement of AUTHORITY: 7 U.S.C. 1901, 7 CFR 2.22, 2.80, the swine covered by said document. 371.4. SOURCE: 66 FR 63615, Dec. 7, 2001, unless (Approved by the Office of Management and otherwise noted. Budget under control number 0579–0069) [44 FR 10309, Feb. 16, 1979, as amended at 48 § 88.1 Definitions. FR 57472, Dec. 30, 1983. Redesignated at 55 FR The following definitions apply to 19253, May 9, 1990] this part: § 85.12 Cleaning and disinfecting APHIS. The Animal and Plant Health means of conveyance. Inspection Service of the U.S. Depart- ment of Agriculture. All means of conveyance used in con- Assembly point. Any facility, includ- nection with the interstate movement ing auction markets, ranches, feedlots, of pseudorabies infected or exposed and stockyards, in which equines are livestock shall be cleaned and dis- gathered in commerce. infected in accordance with § 71.7 of Commercial transportation. Movement this chapter using one of the disinfect- for profit via conveyance on any high- ants registered under the Federal In- way or public road. secticide, Fungicide and Rodenticide Conveyance. Trucks, tractors, trail- Act, as amended (7 U.S.C. 135 et seq.) ers, or semitrailers, or any combina- with herpes virucidal claims. These tion of these, propelled or drawn by disinfectants shall be used in accord- mechanical power. ance with directions on their labels ac- Equine. Any member of the Equidae cepted in connection with their reg- family, which includes horses, asses, istration. mules, ponies, and zebras. [44 FR 10309, Feb. 16, 1979, as amended at 62 Equine for slaughter. Any member of FR 27937, May 22, 1997] the Equidae family being transferred to a slaughter facility, including an as- § 85.13 Cleaning and disinfecting live- sembly point, feedlot, or stockyard. stock markets and other facilities. Euthanasia. The humane destruction Livestock markets and other facili- of an animal by the use of an anes- ties used in connection with the inter- thetic agent or other means that state movement of pseudorabies in- causes painless loss of consciousness fected or exposed livestock shall be and subsequent death. cleaned and disinfected in compliance Feedlot. Any facility which consoli- with § 71.7 of this chapter using one of dates livestock for preconditioning, the disinfectants registered under the feeding, fattening, or holding before Federal Insecticide, Fungicide and being sent to slaughter.

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Owner/shipper. Any individual, part- the regulations in this part, a USDA nership, corporation, or cooperative as- representative may request from any sociation that engages in the commer- individual or other entity who trans- cial transportation of more than 20 ported the equines information regard- equines per year to slaughtering facili- ing the business of that individual or ties, except any individual or other en- other entity. When such information is tity who transports equines to slaugh- requested, the individual or other enti- tering facilities incidental to his or her ty who transported the equines must principal activity of production agri- provide the information within 30 days culture (production of food or fiber). and in a format as may be specified by Owner-shipper certificate. VS Form 10– the USDA representative. 13, 1 which requires the information [66 FR 63615, Dec. 7, 2001, as amended at 76 specified by § 88.4(a)(3) of this part. FR 55216, Sept. 7, 2011] Secretary. The Secretary of Agri- culture. § 88.3 Standards for conveyances. Slaughtering facility. A commercial establishment that slaughters equines (a) The animal cargo space of convey- for any purpose. ances used for the commercial trans- Stallion. Any uncastrated male portation of equines for slaughter equine that is 1 year of age or older. must: Stockyard. Any place, establishment, (1) Be designed, constructed, and or facility commonly known as stock- maintained in a manner that at all yards, conducted, operated, or managed times protects the health and well- for profit or nonprofit as a public mar- being of the equines being transported ket for livestock producers, feeders, (e.g., provides adequate ventilation, market agencies, and buyers, con- contains no sharp protrusions, etc.); sisting of pens, or other enclosures, and (2) Include means of completely seg- their appurtenances, in which live cat- regating each stallion and each aggres- tle, sheep, swine, horses, mules, or sive equine on the conveyance so that goats are received, held, or kept for no stallion or aggressive equine can sale or shipment in commerce. come into contact with any of the USDA. The U.S. Department of Agri- other equines on the conveyance; culture. (3) Have sufficient interior height to USDA backtag. A backtag issued by allow each equine on the conveyance to APHIS that conforms to the eight- stand with its head extended to the character alpha-numeric National fullest normal postural height; and Backtagging System and that provides (4) Be equipped with doors and ramps unique identification for each animal. of sufficient size and location to pro- USDA representative. Any employee of vide for safe loading and unloading. the USDA who is authorized by the (b) Equines for slaughter must not be Deputy Administrator for Veterinary transported in any conveyance that Services of APHIS, USDA, to enforce has the animal cargo space divided into this part. two or more stacked levels, except that conveyances lacking the capability to [66 FR 63615, Dec. 7, 2001, as amended at 76 convert from two or more stacked lev- FR 55216, Sept. 7, 2011] els to one level may be used until De- § 88.2 General information. cember 7, 2006. Conveyances with col- lapsible floors (also known as ‘‘floating (a) State governments may enact and decks’’) must be configured to trans- enforce regulations that are consistent port equines on one level only. with or that are more stringent than the regulations in this part. [66 FR 63615, Dec. 7, 2001, as amended at 76 (b) To determine whether an indi- FR 55216, Sept. 7, 2011] vidual or other entity found to trans- § 88.4 Requirements for transport. port equines for slaughter is subject to (a) Prior to the commercial transpor- 1 Forms may be obtained from the National tation of equines for slaughter, the Animal Health Programs Staff, Veterinary owner/shipper must: Services, APHIS, 4700 River Road Unit 43, (1) For a period of not less than 6 Riverdale, MD 20737–1231. consecutive hours immediately prior to

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the equines being loaded on the con- (ix) The date, time, and place the veyance, provide each equine appro- equine was loaded on the conveyance; priate food (i.e., hay, grass, or other and food that would allow an equine in (x) A statement that the equine was transit to maintain well-being), pota- provided access to food, water, and rest ble water, and the opportunity to rest; prior to transport in accordance with (2) Apply a USDA backtag 2 to each paragraph (a)(1) of this section; and equine in the shipment; (4) Load the equines on the convey- (3) Complete and sign an owner-ship- ance so that: per certificate for each equine being (i) Each equine has enough floor transported. The owner-shipper certifi- space to ensure that no equine is cate for each equine must accompany crowded in a way likely to cause injury the equine throughout transit to or discomfort; and slaughter and must include the fol- (ii) Each stallion and any aggressive equines are completely segregated so lowing information, which must be that no stallion or aggressive equine typed or legibly completed in ink: can come into contact with any other (i) The owner/shipper’s name, ad- equine on the conveyance. dress, and telephone number; (b) During commercial transpor- (ii) The receiver’s (destination) tation of equines for slaughter, the name, address, and telephone number; owner/shipper must: (iii) The name of the auction/market, (1) Drive in a manner to avoid caus- if applicable; ing injury to the equines; (iv) A description of the conveyance, (2) Observe the equines as frequently including the license plate number; as circumstances allow, but not less (v) A description of the equine’s than once every 6 hours, to check the physical characteristics, including physical condition of the equines and such information as sex, breed, color- ensure that all requirements of this ing, distinguishing markings, perma- part are being followed. The owner/ nent brands, tattoos, and electronic de- shipper must obtain veterinary assist- vices that could be used to identify the ance as soon as possible from an equine equine; veterinarian for any equines in obvious (vi) The number of the USDA physical distress. Equines that become backtag applied to the equine in ac- nonambulatory en route must be cordance with paragraph (a)(2) of this euthanized by an equine veterinarian. section; If an equine dies en route, the owner/ (vii) A statement of fitness to travel shipper must contact the nearest at the time of loading, which will indi- APHIS office as soon as possible and cate that the equine is able to bear allow an APHIS veterinarian to exam- weight on all four limbs, able to walk ine the equine. If an APHIS veterinarian is not available, the owner/ship- unassisted, not blind in both eyes, per must contact an equine veteri- older than 6 months of age, and not narian; likely to give birth during the trip; (3) Offload from the conveyance any (viii) A description of any preexisting equine that has been on the convey- injuries or other unusual condition of ance for 28 consecutive hours and pro- the equine, such as a wound or blind- vide the equine appropriate food, pota- ness in one eye, that may cause the ble water, and the opportunity to rest equine to have special handling needs; for at least 6 consecutive hours; and (4) If offloading is required en route 2 USDA backtags are available at recog- to the slaughtering facility, the owner/ nized slaughtering establishments and spe- shipper must prepare another owner- cifically approved stockyards and from State shipper certificate as required by para- representatives and APHIS representatives. graph (a)(2) of this section and record A list of recognized slaughtering establish- the date, time, and location where the ments and specifically approved stockyards may be obtained as indicated in § 78.1 of this offloading occurred. In this situation, chapter. The terms ‘‘State representative’’ both owner-shipper certificates would and ‘‘APHIS representative’’ are defined in need to accompany the equines for § 78.1 of this chapter. slaughter.

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(c) Handling of all equines for slaugh- (b) If the owner/shipper arrives dur- ter shall be done as expeditiously and ing normal business hours, the owner/ carefully as possible in a manner that shipper must not leave the premises of does not cause unnecessary discomfort, a slaughtering facility until the stress, physical harm, or trauma. Elec- equines have been examined by a USDA tric prods may not be used on equines representative. However, if the owner/ for slaughter for any purpose, includ- shipper arrives outside of normal busi- ing loading or offloading on the con- ness hours, the owner/shipper may veyance, except when human safety is leave the premises but must return to threatened. the premises of the slaughtering facil- (d) At any point during the commer- ity to meet the USDA representative cial transportation of equines for upon his or her arrival. slaughter, a USDA representative may (c) Any owner/shipper transporting examine the equines, inspect the con- equines to slaughtering facilities out- veyance, or review the owner-shipper side of the United States must present certificates required by paragraph (a)(3) of this section. the owner-shipper certificates to USDA (e) At any time during the commer- representatives at the border. cial transportation of equines for slaughter, a USDA representative may § 88.6 Violations and penalties. direct the owner/shipper to take appro- (a) The Secretary is authorized to as- priate actions to alleviate the suffering sess civil penalties of up to $5,000 per of any equine. If deemed necessary by violation of any of the regulations in the USDA representative, such actions this part. could include securing the services of (b) Each equine transported in viola- an equine veterinarian to treat an tion of the regulations of this part will equine, including performing eutha- be considered a separate violation. nasia if necessary. (f) The individual or other entity who (Approved by the Office of Management and signs the owner-shipper certificate Budget under control number 0579–0160) must maintain a copy of the owner- shipper certificate for 1 year following PART 89—STATEMENT OF POLICY the date of signature. UNDER THE TWENTY-EIGHT HOUR (Approved by the Office of Management and LAW Budget under control numbers 0579–0160 and 0579–0332) Sec. [66 FR 63615, Dec. 7, 2001, as amended at 76 89.1 Amount of feed. FR 55216, Sept. 7, 2011] 89.2 Two or more feedings at same station. 89.3 Feeding, watering, and resting live- § 88.5 Requirements at a slaughtering stock in the car. facility. 89.4 Watering. (a) Upon arrival at a slaughtering fa- 89.5 Feeding pens. cility, the owner/shipper must: AUTHORITY: 49 U.S.C. 80502; 7 CFR 2.22, 2.80, (1) Ensure that each equine has ac- and 371.4. cess to appropriate food and potable water after being offloaded; SOURCE: 28 FR 5967, June 13, 1963, unless (2) Present the owner-shipper certifi- otherwise noted. cates to a USDA representative; § 89.1 Amount of feed. (3) Allow a USDA representative access to the equines for the purpose of (a) Under normal conditions, the examination; and amount of feed designated in the fol- (4) Allow a USDA representative ac- lowing schedule will be considered as cess to the animal cargo area of the sustaining rations for livestock in conveyance for the purpose of inspec- transit when fed at the intervals re- tion. quired by the Twenty-Eight Hour Law:

At second and subse- Species and quantity of livestock At first feeding station quent feeding stations

Cattle and beef type or range calves (for each car 1) ...... 200 lbs. of hay 1,2 ...... 300 lbs. of hay. 1,2

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At second and subse- Species and quantity of livestock At first feeding station quent feeding stations

Dairy calves (for each car deck 1) ...... 100 lbs. of hay 1,2 ...... 150 lbs. of hay. 1,2 Horses and mules (for each car 1) ...... 400 lbs. of hay 1,2 ...... 400 lbs. of hay. 1,2 Sheep and goats (for each car deck 1) ...... 200 lbs. of hay 1,2 ...... 300 lbs. of hay. 1,2 Lambs and kids (for each car deck 1) ...... 100 lbs. of hay 1,2 ...... 150 lbs. of hay. 1,2 Swine (for each carload lot, in single or double deck car, the amount of shelled corn 2 indicated): Lots of not more than 18,000 lbs ...... 2 bushels ...... 2 bushels. More than 18,000 lbs. but not more than 21,000 lbs ...... 21⁄2 bushels ...... 21⁄2 bushels. More than 21,000 lbs. but not more than 24,000 lbs ...... 3 bushels ...... 3 bushels. More than 24,000 lbs. but not more than 27,000 lbs ...... 31⁄2 bushels ...... 31⁄2 bushels. More than 27,000 lbs. but not more than 30,000 lbs ...... 4 bushels ...... 4 bushels. More than 30,000 lbs.—proportionately larger amounts. 1 The requirements set forth the sustaining rations for a full load of livestock in a railroad car 40 feet in length. The requirements for a full load of livestock in railroad cars of different sizes should be modified proportionately, i.e., a load of livestock transported in a car 50 feet in length would require an additional 25 percent of feed or 2.5 percent for each additional foot of car over 40 feet. 2 Or the equivalent in other suitable feed. Dairy calves too young to eat hay or grain, or shipped without their dams, should be given a sufficient amount of prepared calf feed, milk, raw eggs, or other suitable feed. All feed should be of good quality.

(b) When the owner of a consignment destination, whichever is closer, would of livestock desires that they be fed not ordinarily exceed 40 hours. larger amounts of feed than those designated in paragraph (a) of this section § 89.3 Feeding, watering, and resting for the particular kind and quantity of livestock in the car. livestock, or the carrier believes that (a) Livestock should be unloaded into they should be fed larger amounts, the pens of the character described in amounts to be fed should be agreed § 89.5(a) for feeding, watering, and rest- upon, if practicable, by the owner and ing, unless there is ample room in the the carrier at the time the animals are car for all of the animals to lie down at offered for shipment. the same time. (c) When emergency conditions arise, (b) If livestock are watered in the such as severe changes in the weather, car, adequate facilities should be pro- which increase the rigors of transpor- vided and ample water furnished to in- tation, the livestock should receive sure all the animals an opportunity to amounts of feed, additional to those drink their fill. In the case of hogs, designated in paragraph (a) of this sec- water should be available for not less tion, sufficient to sustain them until than 1 hour. they arrive at the next feeding station (c) Livestock unloaded for feed and or destination. water and returned to the car for rest (d) When the movement of livestock should be allowed to remain in the pens is delayed en route so that the period not less than 2 hours. of their confinement in the cars mate- (d) Livestock unloaded for water and rially exceeds that specified by the returned to the car for feed and rest Twenty-Eight Hour Law, the livestock should be allowed to remain in the pens should receive additional feed in pro- not less than 1 hour. portion to such excess time. (e) When livestock are fed in the car, the feed should be evenly distributed § 89.2 Two or more feedings at same throughout the car. station. When livestock are held at a feeding § 89.4 Watering. station 12 hours after the last previous Livestock should be furnished an feed has been substantially consumed, ample supply of potable water. Water they should again be fed the ration pre- treated with chemicals for industrial scribed by § 89.1(a) for that station: Pro- or boiler use, or taken from streams or vided, however, That they may be held ponds containing sewage, mud, or other without such feeding for a period objectionable matter should not be longer than 12 hours if the time they used. Troughs and other receptacles are so held, added to the time required should be clean. In cold weather, the to reach the next feeding station or water should be free from ice.

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§ 89.5 Feeding pens. concrete, cinders, gravel, hard-packed earth, or other suitable material, and (a) Stock pens and other enclosures (4) suitable protection from weather for feeding, watering, and resting live- reasonably to be expected in the region stock in transit should have (1) suffi- in which the pens are located. cient space for all of the livestock to (b) Care should be taken to protect lie down at the same time, (2) properly livestock unloaded en route at a point designed facilities for feeding and wa- having marked difference in tempera- tering the livestock, (3) reasonably ture from that at the point from which well-drained, clean, and safe floors of they were shipped.

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PART 91—INSPECTION AND HAN- SOURCE: 42 FR 28990, June 7, 1977, unless DLING OF LIVESTOCK FOR EX- otherwise noted. PORTATION Subpart A—General Provisions Subpart A—General Provisions § 91.1 Definitions. Sec. Whenever in the regulations in this 91.1 Definitions. part the following terms are used, they 91.2 Animals to be handled in compliance with regulations. shall be construed as follows: 91.3 General export requirements. Accredited veterinarian. A veteri- 91.4 Other movements and conditions. narian approved by the Administrator in accordance with the provisions of Subpart B—Diagnostic Tests, Treatments part 161 of this title to perform functions specified in parts 1, 2, 3, and 11 of 91.5 Cattle. 91.6 Goats. subchapter A, and subchapters B, C, 91.7 Captive cervids. and D of this chapter, and to perform 91.8 Sheep. functions required by cooperative 91.9 Swine. State-Federal disease control and eradication programs. Subpart C—Ports of Embarkation, Facilities, Administrator. The Administrator, Health Certification Animal and Plant Health Inspection 91.14 Ports of embarkation and export in- Service, or any person authorized to spection facilities. act for the Administrator. 91.15 Inspection of animals for export. Animal and Plant Health Inspection 91.16 Certification of animals for export. Service. The Animal and Plant Health Inspection Service of the United States Subpart D—Inspection of Vessels and Department of Agriculture (APHIS or Accommodations Service). 91.17 Accommodations for humane treat- Animals. Horses, cattle (including ment of animals on ocean vessels. American bison), captive cervids, 91.18 Cleaning and disinfection of transport sheep, swine, and goats. carriers for export. APHIS representative. An individual 91.19 Inspection of ocean vessels prior to loading. employed by APHIS who is authorized 91.20 General construction. to perform the function involved. 91.21 Ventilation. Department. The United States De- 91.22 Protection from heat of boilers and en- partment of Agriculture. gines. Horses. Horses, mules, and asses. 91.23 Loading ramps and doors. Inspector. An inspector of the Animal 91.24 Attendants. and Plant Health Inspection Service. 91.25 Space requirements for animals on ocean vessels. Miniature swine. Swine bred and 91.26 Concrete flooring. raised as pets or for laboratory testing 91.27 Troughs and hayracks. purposes that do not weigh more than 91.28 Stanchions and rails. 100 pounds at maturity. 91.29 Hatches. Official brucellosis vaccinate. An offi- 91.30 Defective fittings. cial adult vaccinate or an official calfhood vaccinate as defined in § 78.1 Subpart E—Cleaning and Disinfecting of of this chapter. Aircraft Origin health certificate. An official 91.41 Cleaning and disinfecting of aircraft. document issued by an APHIS rep- AUTHORITY: 7 U.S.C. 8301–8317; 19 U.S.C. resentative or an accredited veteri- 1644a(c); 21 U.S.C. 136, 136a, and 618; 46 U.S.C. narian at the point of origin of a ship- 3901 and 3902; 7 CFR 2.22, 2.80, and 371.4. ment of animals to be moved under

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this part, which shows the identifica- time period, and the origin health cer- tion tag, tattoo, or registration num- tificate will remain valid for that time ber or similar identification of each period. The origin health certificate animal to be moved, the number, breed, must certify that the animals were sex, and approximate age of the ani- found upon inspection to be healthy mals covered by the document, the and free from evidence of commu- date and place of issuance, the points nicable disease and exposure to com- of origin and destination, the con- municable disease. The origin health signor, and the consignee, and which certificate must be endorsed by an au- states that the animal or animals iden- thorized APHIS veterinarian in the tified on the certificate meet the ex- State of origin and must include any port health requirements. test results added by the authorized Premises of origin. The farm or other APHIS veterinarian pursuant to premises where the animals intended § 161.4(k) of this chapter (any added test for export are being raised or assem- results must be initialed by the author- bled, or both, immediately before ized veterinarian). The origin health movement for export. certificate must individually identify Roofing paper. Any saturated roofing the animals in the shipment as to spe- paper of a grade known to the trade as cies, breed, sex, and age and, if applica- 30–pound roofing paper. ble, must also show registration name State of origin. The State in which the and number, tattoo markings, or other premises of origin is located. natural or acquired markings. The ori- Veterinary Services. The Veterinary gin health certificate must include all Services, Animal and Plant Health In- test results, certifications, or other spection Service of the Department. statements required by the country of [42 FR 28990, June 7, 1977, as amended at 53 destination. FR 51746, Dec. 23, 1988; 57 FR 23047, June 1, (b) Inspection. All animals in each ex- 1992; 57 FR 39353, Aug. 31, 1992; 63 FR 72129, port shipment, except animals intended Dec. 31, 1998; 72 FR 40065, July 23, 2007] for export by land to Mexico or Canada, shall have been inspected, tested, or § 91.2 Animals to be handled in compli- treated in the manner prescribed in ance with regulations. this part prior to the movement of the No animals covered by the regula- export shipment to the export inspections in this part shall be exported to a tion facility. All animals in each ex- foreign country except in compliance port shipment intended for export by with the provisions in this part. land to Mexico or Canada shall have been inspected, tested, or treated in § 91.3 General export requirements. the manner prescribed in this part (a) All animals intended for expor- prior to the movement of the animals tation to a foreign country, except by from the State of origin. The Adminis- land to Mexico or Canada, must be ac- trator may, upon request of the appro- companied from the State of origin of priate animal health official of the the export movement to the port of country of destination, waive the tu- embarkation by an origin health cer- berculosis and brucellosis tests re- tificate. All animals intended for ex- ferred to in §§ 91.5(a) and (b), 91.6(a)(1) portation by land to Mexico or Canada and (2), and 91.9(a) of this part when he must be accompanied from the State of finds such tests are not necessary to origin of the export movement to the prevent the exportation of diseased border of the United States by an ori- animals from the United States. gin health certificate. The origin (c) Testing. All samples for tests re- health certificate must certify that the quired by §§ 91.5 through 91.13 for expor- animals were inspected within the 30 tation of animals under this section days prior to the date of export, except shall be taken by an inspector or an ac- as follows: When the Administrator al- credited veterinarian in the State of lows sampling or testing to be done origin of the export movement. The more than 30 days prior to the date of samples must be taken and tests must export, in accordance with paragraph be made within the 30 days prior to the (c) of this section, then the animals date of export, except that the Admin- also may be inspected within that same istrator may allow such sampling or

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testing to be conducted more than 30 § 91.4 Other movements and condi- days prior to the date of export if re- tions. quired or allowed by the receiving The Administrator may, upon re- country, and the tuberculin test may quest in specific cases, permit the ex- be conducted within the 90 days prior portation of livestock not otherwise to the date of export. The test for bru- provided for in this part under such cellosis shall be conducted in a cooper- conditions as he may prescribe in each ating State-Federal laboratory 1 in ac- specific case to prevent the spread of cordance with the Recommended Bru- livestock diseases and to insure the hu- cellosis Eradication Uniform Methods mane treatment of the animals while and Rules. in transit. (d) Movement in cleaned and dis- [43 FR 27171, June 23, 1978. Redesignated at 45 infected carriers or containers. The origin FR 86412, Dec. 31, 1980, and amended at 57 FR health certificate accompanying ani- 23047, June 1, 1992] mals shall be accompanied by a statement from the issuing accredited vet- Subpart B—Diagnostic Tests, erinarian or inspector that the means Treatments of conveyance or container has been cleaned and disinfected since last used for animals with a disinfectant ap- SOURCE: 45 FR 86412, Dec. 31, 1980, unless proved under § 71.10 of this chapter, otherwise noted. prior to loading, or that the carrier or § 91.5 Cattle. container has not previously been used in transporting animals. In order to be eligible for export, cat- (e) Clean and disinfected facilities for tle shall be tested with results as specified in this section, and the origin unloading animals. Animals intended health certificate shall specify the type for exportation to Mexico or Canada or of tests conducted, the dates of the enroute to a port of embarkation shall tests, and the results of the tests. be unloaded only into a facility which (a) Tuberculosis. All cattle over 1 shall have been cleaned and disinfected month of age shall be negative to a with a disinfectant approved under caudal intradermal tuberculin test § 71.10 of this chapter, under the super- using 0.1 ml. of tuberculin with a read- vision of an inspector or an accredited ing obtained 72 hours (plus or minus six veterinarian prior to such unloading. A hours) after injection as prescribed in statement certifying to such action Veterinary Services Memorandum shall be attached to the origin health 552.15 ‘‘Instructions and Procedures for certificate by the supervising inspector Conducting Tuberculin Tests in Cat- or accredited veterinarian. tle,’’ section VIII A. 2 (Approved by the Office of Management and (1) Provided that, such tests are not Budget under control number 0579–0020) required for any of the following: (i) Cattle exported directly to slaugh- [42 FR 28990, June 7, 1977, as amended at 44 ter in a country that the Adminis- FR 28298, May 15, 1979. Redesignated and trator has determined has an accept- amended at 45 FR 86412, Dec. 31, 1980; 48 FR 57472, Dec. 30, 1983; 57 FR 23047, 23048, June 1, able tuberculosis surveillance system 1992; 59 FR 48994, Sept. 26, 1994; 59 FR 67613, at slaughter plants and that agrees to Dec. 30, 1994; 60 FR 4536, Jan. 24, 1995; 60 FR share any findings of tuberculosis in 9611, Feb. 21, 1995; 60 FR 13898, Mar. 15, 1995; U.S. origin cattle with APHIS; 67 FR 11560, Mar. 15, 2002; 75 FR 57658, Sept. (ii) Cattle exported directly to 22, 2010] slaughter from a State designated as an Accredited-Free State in § 77.7 of this chapter; 1 A list of cooperating State-Federal laboratories may be obtained from the Adminis- 2 Copies of this publication may be ob- trator, Animal and Plant Health Inspection tained from the Animal and Plant Health In- Service, Veterinary Services, National Cen- spection Service, Veterinary Services, Na- ter for Import-Export, 4700 River Road, Unit tional Center for Import-Export, 4700 River 38, Riverdale, Maryland 20737–1231. Road, Riverdale, Maryland 20737–1231.

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(iii) Cattle exported to a country ectoparasites within 30 days preceding that does not require cattle from the the date of export. Such treatment United States to be tested for tuber- shall be made using a pesticide reg- culosis as described in this part; or istered by the Environmental Protec- (iv) Cattle exported from a State des- tion Agency for use in treating animals ignated as an Accredited-free State in infested with the ectoparasite involved § 77.7 of this chapter to a country that in accordance with the label require- does not require cattle from Accred- ments. Treatment shall be personally ited-free States to be tested for tuber- supervised and certified on the origin culosis as described in this part. health certificate by an accredited vet- (2) The Administrator has deter- erinarian who shall be ready to apply mined that the following countries an antidote if adverse side effects occur have an acceptable tuberculosis sur- following treatment. veillance system at slaughter plants: Canada and Mexico. (Approved by the Office of Management and Budget under control number 0579–0020) (b) Brucellosis. All cattle over 6 months of age shall be negative to a [45 FR 86412, Dec. 31, 1980, as amended at 48 test for brucellosis conducted as pre- FR 57472, Dec. 30, 1983; 55 FR 12634, Apr. 5, scribed in ‘‘Standard Agglutination 1990; 56 FR 366, Jan. 4, 1991; 57 FR 23047, June 1, 1992; 59 FR 67614, Dec. 30, 1994; 60 FR 4536, Test Procedures for the Diagnosis of Jan. 24, 1995; 60 FR 13898, Mar. 15, 1995; 61 FR 2 Brucellosis’’ or ‘‘Supplemental Test 6918, Feb. 23, 1996; 62 FR 3446, Jan. 23, 1997; 72 Procedures for the Diagnosis of Brucel- FR 40066, July 23, 2007] losis.’’ 2 (1) Provided that, such tests are not § 91.6 Goats. required for any of the following: (a) In order to be eligible for export, (i) Official vaccinates of dairy breeds goats shall be tested with results as under 20 months of age; specified in this section, and the origin (ii) Official vaccinates of beef breeds health certificate for such animals under 24 months of age; shall specify the type of test con- (iii) Steers and spayed heifers; ducted, the date of the tests, and the (iv) Cattle exported directly to results of the tests. slaughter in a country that the Admin- (1) Tuberculosis. All goats over 1 istrator has determined has an accept- month of age shall be negative to a able brucellosis surveillance system at caudal intradermal tuberculin test slaughter plants and that agrees to using 0.1 ml. of tuberculin with a read- share any findings of brucellosis in ing obtained 72 hours (plus or minus 6 U.S. origin cattle with APHIS; hours) after injection as prescribed in (v) Cattle exported directly to Veterinary Services Memorandum slaughter from a State designated as a 552.15. Class Free State in 9 CFR 78.41; (2) Brucellosis. Dairy and breeding (vi) Cattle exported to a country that goats shall be negative to a plate or does not require cattle from the United tube agglutination test for brucellosis States to be tested for brucellosis as as prescribed in ‘‘Standard Agglutina- described in this part; or tion Test Procedures for the Diagnosis (vii) Cattle exported from a State of Brucellosis.’’ 2 designated as a Class Free State in § 78.41 of this chapter to a country that (3) No goat shall be exported if it is a does not require cattle from Class Free scrapie-positive animal or an exposed States to be tested for brucellosis as animal, as defined in 9 CFR parts 54 described in this part. and 79, or if it has ever been in an in- (2) The Administrator has deter- fected flock, source flock, or trace mined that the following country has flock, as defined in 9 CFR parts 54 and an acceptable brucellosis surveillance 79; or if it is the progeny, parent, or system at slaughter plants: Canada. sibling of any scrapie-positive animal. (c) Treatment for ectoparasites. All cat- (4) Exemptions. (i) Goats exported for tle, except those found free of immediate slaughter need not comply ectoparasites or those intended for ex- with the requirements of paragraphs portation for slaughter purposes to any foreign country, shall be treated for 2 See footnote 2 to § 91.5.

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(a)(1), (a)(2), (a)(3), and (a)(5) of this proved by the Administrator. 3 except section. that sheep for export to Canada or (ii) Tuberculosis testing is not re- Mexico for immediate slaughter may quired for goats over 1 month of age ex- be identified by flock brands. ported to a country that does not re- (Approved by the Office of Management and quire goats from the United States to Budget under control number 0579–0020) be tested for tuberculosis as described [45 FR 86412, Dec. 31, 1980, as amended at 57 in paragraph (a)(1) of this section. FR 23047, 23048, June 1, 1992; 59 FR 48994, (iii) Brucellosis testing is not re- Sept. 26, 1994; 59 FR 67133, Dec. 29, 1994; 59 FR quired for dairy and breeding goats ex- 67614, Dec. 30, 1994; 61 FR 6918, Feb. 23, 1996] ported to a country that does not require goats from the United Stated to § 91.9 Swine. be tested for brucellosis as described in (a) No swine shall be exported if they paragraph (a)(2) of this section. were fed garbage at any time. The (5) All goats intended for export shall swine shall be accompanied by a cer- be identified by eartags or tattoos ap- tification from the owner stating that proved by the Administrator, except they were not fed garbage, and that that goats for export to Canada or any additions to the herd made within Mexico for immediate slaughter may the 30 days immediately preceding the be identified by flock brands. export shipment have been maintained isolated from the swine to be exported. (Approved by the Office of Management and (b) Except as provided in paragraph Budget under control number 0579–0020) (c) of this section, all breeding swine [45 FR 86412, Dec. 31, 1980, as amended at 48 shall be tested for and show negative FR 57472, Dec. 30, 1983; 57 FR 23048, June 1, test results to brucellosis by a test pre- 1992; 59 FR 48994, Sept. 26, 1994; 60 FR 4536, scribed in ‘‘Standard Agglutination Jan. 24, 1995; 76 FR 29992, May 24, 2011] Test Procedures for the Diagnosis of Brucellosis’’ or ‘‘Supplemental Test § 91.7 Captive cervids. Procedures for the Diagnosis of Brucel- To be eligible for export, a captive losis.’’ The test results shall be classi- cervid must be accompanied by an ori- fied negative in accordance with the gin health certificate stating that the provisions prescribed in the Rec- captive cervid has tested negative to ommended Brucellosis Eradication an official single cervical tuberculin Uniform Methods and Rules, chapter 2, test for tuberculosis, as described in part II, G, 1, 2, and 3. part 77, subpart B, of this chapter, (c) Breeding swine exported to a within 90 days prior to export. The ori- country that does not require breeding gin health certificate must specify the swine from the United States to be date the test was conducted and the tested for brucellosis need not comply test results. with the requirements of paragraph (b) of this section. [63 FR 72129, Dec. 31, 1998] [76 FR 29992, May 24, 2011] § 91.8 Sheep. (a) No sheep shall be exported if it is Subpart C—Ports of Embarkation, a scrapie-positive animal or an exposed Facilities, Health Certification animal, as defined in 9 CFR parts 54 and 79, or if it has ever been in an in- § 91.14 Ports of embarkation and export inspection facilities. fected flock, source flock, or trace flock, as defined in 9 CFR parts 54 and (a) All ports that have export inspec- 79; or if it is the progeny, parent, or tion facilities which the Administrator sibling of any scrapie-positive animal. (1) Sheep exported for immediate 3 Information concerning eartags or tattoos slaughter need not comply with the re- approved by the Administrator may be ob- quirements of paragraph (a)(2) of this tained, upon request, from the Animal and section. Plant Health Inspection Service, Veterinary Services, National Center for Import-Export, (2) All sheep intended for export shall 4700 River Road Unit 38, Riverdale, Maryland be identified by eartags or tattoos ap- 20737–1231.

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has determined satisfy the require- alleys and over all of the inspection ments of paragraph (c) of this section area. are hereby designated as ports of em- (2) Size. The facility shall be large barkation. A list of designated ports of enough to accommodate all the ani- embarkation can be viewed on the mals in a single export shipment at one Internet at http://www.aphis.usda.gov/ time. A minimum space twice the rate regulations/vs/iregs/animals/ or obtained required per animal in § 91.25(b) shall be from a Veterinary Services area office. provided for each animal. Facilities Information on area offices is available that inspect horses must have ceilings at http://www.aphis.usda.gov/ at least 12 feet high in any areas where animallhealth/arealoffices/. All ani- horses are inspected. mals, except animals being exported by (3) Inspection implements. The facility land to Mexico or Canada, shall be ex- shall have a separate area available for ported through said ports or through inspection and identification of the ports designated in special cases under animals. Pens and animal restraining paragraph (b) of this section. devices shall be provided in this area (b) In special cases, other ports may which are sufficient for the inspection be designated as ports of embarkation and identification of each animal. Pens by the Administrator, with the concur- or yards shall be provided for appro- rence of the Commissioner of the Bu- priate segregation, treatment, or both, reau of Customs and Border Protec- of animals of questionable health station, when the exporter can show to tus apart from animals qualified for exportation under this part. the satisfaction of the Administrator (4) Cleaning and disinfection. The fa- that the animals to be exported would cility and equipment shall be cleaned suffer undue hardship if they are re- and disinfected with a disinfectant per- quired to be moved to a port listed as mitted under § 71.10 of this chapter a designated port of embarkation in ac- under the supervision of a Federal in- cordance with paragraph (a) of this sec- spector prior to entry of each export tion. Ports shall be designated in spe- shipment into the export inspection fa- cial cases as ports of embarkation only cility. Personnel tending the animals if the inspection facilities are approved shall, if they come in contact with ani- as meeting the requirements of para- mals outside of the facility, be required graph (c) of this section. to change or sanitize their outer cloth- (c) Standards for export inspection fa- ing and footwear. All facilities must cilities. Inspection facilities located at have running water available to wash ports of embarkation designated under and disinfect the facilities. On and paragraph (a) of this section, and in- after March 23, 1995, facilities to be ap- spection facilities designated in special proved must have a drainage system; cases under paragraph (b) of this sec- and, on and after March 23, 1997, every tion, shall meet the following require- facility approved before March 23, 1995, ments: must have a drainage system. The (1) Materials. Floors of pens, alleys, drainage system must control surface and chutes shall be made of impervious drainage into or from the facility in a materials and finished so as to be skid- manner that prevents any significant resistant. Impervious floors are those risk of livestock diseases being spread constructed of a material that resists into or from the facility. the absorption of fluids. Such mate- (5) Feed and water. An ample supply rials include concrete, asphalt, brick, of running, potable water shall be made metal, or other synthetic material that available to the animals intended for may be cleaned and disinfected. export, and in cold weather such water Fences, gates, and other parts of the shall be kept free of ice. Feed and feed- facility shall be constructed of wood, ing facilities appropriate for the ani- metal, or other material that will se- mals intended for export shall be pro- curely restrain the animals in a safe vided. and humane manner. The facility shall (6) Access; approval of arrangements. have a roof adequate to protect the Access to all parts of the facility shall animals from inclement weather over be allowed to an inspector at all times, at least three-fourths of the pens and day or night, and the arrangement for

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handling the animals shall be subject this section, shall be obtained from the to the approval of the inspector. Ap- Administrator. Approval of an export proval shall be granted by the inspec- inspection facility under paragraph (a) tor if he finds that such arrangements or (b) of this section will be denied or will not permit the dissemination of revoked for failure to meet the stand- communicable diseases of livestock to ards in paragraph (c) of this section. the animals in the export shipment. Designated ports of embarkation and (7) Testing and treatment. Testing and export facilities shall be reevaluated treatment of animals in export inspec- annually, by means of an APHIS site tion facilities shall be performed by an inspection, for continued compliance accredited veterinarian under the su- with the standards contained in para- pervision of an APHIS veterinarian. graph (c) of this section. If the port or Tests related to APHIS animal disease facility fails to pass the annual inspec- programs shall be performed in accord- tion, its designation will be revoked, ance with the Recommended Brucel- and it will be removed from the list of losis Eradication Uniform Methods and designated ports and facilities. A writ- Rules. ten notice of any proposed denial or (8) Location. The arrangement and lo- revocation shall be given to the oper- cation of the facilities shall provide for ator of the facility, and he or she will the isolation of all animals in the facil- be given an opportunity to present his ity from contact with any other ani- or her views thereon. Such notice shall mals. Isolation of separate export ship- list in detail the deficiencies con- ments in the facility shall be at the cerned. After remedying the defi- discretion of the inspector. ciencies, an operator may request an- (9) Disposal of animal wastes. The ap- other inspection. Approval of a port of plication for approval of an export in- embarkation in connection with the spection facility shall be accompanied designation of an export inspection fa- by a certification from the authorities cility in special cases shall be limited having jurisdiction over environmental to the special case for which the des- affairs in the locality of the facility ignation was made. stating that the facility complies with (Approved by the Office of Management and the applicable State and local regula- Budget under control number 0579–0020) tions or ordinances and the require- [42 FR 28990, June 7, 1977] ments, if any, of the United States En- vironmental Protection Agency, re- EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 91.14, see the List of CFR garding disposal of animal wastes. Sections Affected, which appears in the (10) Lighting. The facility shall be Finding Aids section of the printed volume equipped with artifical lighting to pro- and at www.fdsys.gov. vide not less than 70 foot candle power in the inspection area and not less than § 91.15 Inspection of animals for ex- 40 foot candle power in the remainder port. of the facility. (a) All animals offered for expor- (11) Office and rest room. A suitable of- tation to any foreign country, except fice and adequate rest room facilities by land to Mexico or Canada, shall be shall be provided at the export inspec- inspected within 24 hours of embar- tion facility site for use of the inspec- kation by an APHIS veterinarian at an tors. The facility must have a working export inspection facility at a port list- telephone. ed as a designated port of embarkation (12) Walkways. Facilities where in accordance with § 91.14(a), or at a horses are inspected must have walk- port or inspection facility designated ways in front of horse stalls wide by the Administrator in a special case enough to allow APHIS personnel to under § 91.14(b). safely remove horses from the stalls for (b) Such animals shall be held for a inspection, if necessary. period of not less than 5 hours at the (d) Approval and denial or revocation of port of embarkation or export inspec- approval. Approval of each export in- tion facility during which time the ani- spection facility for designation under mals shall be given a careful visual paragraph (a) of this section, and in health inspection. Sorting, grouping, special cases under paragraph (b) of identification, or other handling of the

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animals by the exporter may be before Subpart D—Inspection of Vessels or after this period of time. If indi- and Accommodations vidual clinical inspection of an animal is deemed necessary by an APHIS vet- § 91.17 Accommodations for humane erinarian for the purpose of deter- treatment of animals on ocean ves- mining its health status, such inspec- sels. tion may be made during this period of (a) The owner or operator of an ocean time or thereafter. vessel carrying animals from the (c) Feed and water. All animals shall United States to a foreign country be allowed a period of at least 5 hours shall provide, for such animals, feed for rest at the export inspection facil- and water, space, ventilation, fittings, ity, with adequate feed and water and other facilities aboard the carrier available, before movement to an as set forth in this part. For animals ocean vessel or aircraft for loading for embarked for a voyage which will be of export. (This may be the same period more than 36 hours duration, there required by paragraph (b) for health in- shall be provided to the satisfaction of spection.) However, feed and water will the inspector sufficient amounts of not be required if the animals were suitable feed and fresh water, and prop- transported to the export inspection fa- er accommodations shall be provided cility in a carrier in which adequate on board for storage and distribution of feed and water were provided and if suf- the water and feed. The feed shall not ficient evidence is presented to an be exposed to the weather at sea. How- APHIS veterinarian that the animals, ever, such feed and water shall not be if under 30 days of age, will arrive in required if it is determined by the the country of destination within 24 APHIS veterinarian that the animals, hours after they were last fed and wa- if under 30 days of age will arrive in the tered, in the United States, or in the country of destination within 24 hours case of other animals within 36 hours after they were last fed and watered in after they were last fed and watered in the United States, or, in the case of the United States other animals, within 36 hours after [42 FR 28990, June 7, 1977, as amended at 44 they were last fed and watered in the FR 28299, May 15, 1979. Redesignated at 45 FR United States. 86413, Dec. 31, 1980, and amended at 57 FR (b) Owners masters, or operators of 23048, June 1, 1992; 60 FR 4536, Jan. 24, 1995; 60 such vessels shall not accept for trans- FR 9611, Feb. 21, 1995; 76 FR 18348, Apr. 4, portation any animal that in the judg- 2011] ment of the APHIS veterinarian is in an unfit condition to withstand the rig- § 91.16 Certification of animals for export. ors of such transportation. Further, no animal intended for export shall be If, upon inspection by an APHIS vet- placed aboard any ocean vessel, unless erinarian at the export inspection fa- in the opinion of the inspector the cility, the animals offered for export loading arrangements, fittings, ven- are found to be sound, healthy, and free tilation systems, and the arrangements from evidence of communicable disease provided by the vessel for their use rea- or exposure thereto, an export certifi- sonably assure arrival of a viable ani- cate, VS Form 17–37, shall be issued by mal in the country of destination. said APHIS veterinarian and shall con- Halters, ropes, or other suitable equip- tain a statement to that effect. ment provided for the handling and [42 FR 28990, June 7, 1977. Redesignated at 45 tying of horses shall be found to be sat- FR 86413, Dec. 31, 1980, as amended at 57 FR isfactory by the APHIS veterinarian to 23047, 23048, June 1, 1992] assure humane treatment of the animals. [42 FR 28990, June 7, 1977. Redesignated at 45 FR 86413, Dec. 31, 1980, as amended at 57 FR 23047, June 1, 1992]

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§ 91.18 Cleaning and disinfection of porter, transporting company, or their transport carriers for export. agent, at a foreign port, for an inspec- All fittings, utensils and equipment, tion to determine if the fittings aboard unless new, to be used in the loading, the vessel are in compliance with the stowing, or other handling of animals provisions of this part. A notarized aboard surface vessels under the provi- statement from an engineering concern sions of this part, shall first be cleaned shall be required to certify to the rate and disinfected under the supervision of air exchange in each compartment. of an inspector before being used for, or Such notarized statement shall be rein connection with, the transportation quired upon first use of such vessel: of animals from any United States Provided, That such notarized state- port. Such disinfection of halters, ment may again be required by the Ad- ropes, and similar equipment used in ministrator if substantive changes in handling and tying of animals shall be fittings aboard the vessel have been by immersion in an approved disinfect- made since the vessel was last cer- ant. When the surface vessel has last tified. been used to carry livestock to or from [42 FR 28990, June 7, 1977. Redesignated at 45 a foot-and-mouth disease infected FR 86413, Dec. 31, 1980, and amended at 57 FR country, the approved disinfectant 23047, 23048, June 1, 1992] shall be a freshly prepared solution of: (a) Sodium carbonate (4 percent) in § 91.20 General construction. the proportion of 1 pound to 3 gallons A variety of construction materials of water. such as wood, metal plate, or pipe may (b) 4 percent sodium carbonate plus be used for stalls, crates, or pens 0.1 percent sodium silicate. aboard ocean vessels. Pipe fittings (c) Sodium hydroxide (Lye) prepared have the advantage of smooth surfaces, in a fresh solution in the proportion of easy maintenance, long range economy not less than 1 pound avoirdupois of so- and spaces between pipe rails to allow dium hydroxide of not less than 95 per- for feeding, watering, cleaning and bet- cent purity to 6 gallons of water, or ter ventilation. Material used for one 131⁄2-ounce can to 5 gallons of stalls, crates, or pens shall be properly water. 7 formed, closely fitted, and rigidly se- For carriers returning from other for- cured in place. Special care shall be eign countries, the approved disinfect- taken to design and finish all edges, ant shall be a disinfectant permitted welds, and hardware that are accessible for use under § 71.10, part 71 of this to animals. A combination of wood and chapter. steel pipe or other steel profile construction may be accepted if the con- [42 FR 28990, June 7, 1977. Redesignated and amended at 45 FR 86413, Dec. 31, 1980; 53 FR struction complies with the regula- 51746, Dec. 23, 1988] tions in this part. Where the sides of pens are adjacent to the ship’s sides § 91.19 Inspection of ocean vessels which have steel casing, frames, stays prior to loading. or similar fittings, the carrier shall It shall be the responsibility of the cover these profiles with wooden bat- owners or the masters of an ocean ves- tens of at least 2 inch thick lumber or sel intended for use in exporting live- plywood of similar strength to prevent stock to present the vessel to an in- animals from injury. spector at a United States port of em- [42 FR 28990, June 7, 1977. Redesignated at 45 barkation or at the descretion of the FR 86413, Dec. 31, 1980] Administrator, upon request of the ex- § 91.21 Ventilation. 7Due to the extreme caustic nature of so- Each underdeck compartment on dium hydroxide solution, precautionary which animals are being transported measures such as the wearing of rubber aboard an ocean vessel shall be gloves, boots, raincoat, and goggles should be observed. An acid solution such as vinegar equipped with a system of mechanical shall be kept readily available in case any of ventilation that will furnish a com- the sodium hydroxide solution should come plete change of air in each compart- in contact with the body. ment every 2 minutes when deck

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height 8 is less than 8 feet and every 21⁄2 24 inches. A sufficient number of minutes when the deck height 8 exceeds athwartship alleyways at least 24 8 feet. Spare motors and fans shall be inches in width shall be provided to af- available on board, for replacement or ford ready access to scuppers and to repair of the ventilation system during ends of alleyways running fore and aft. the voyage. A spare motor and fan of However, on exposed decks where scup- an approved type in working order pers and the end of fore and aft alley- shall be aboard the vessel for each type ways are readily accessible athwart- of motor or fan used. Net pen space in ship alleyways are not required and if any compartment shall not exceed 80 the alleyways are to be used for feeding percent of the deck area. or watering livestock, but not for loading or unloading of livestock, such al- [42 FR 28990, June 7, 1977. Redesignated at 45 leyways shall have a minimum width FR 86413, Dec 31, 1980] of 28 inches. § 91.22 Protection from heat of boilers [42 FR 28990, June 7, 1977. Redesignated at 45 and engines. FR 86413, Dec. 31, 1980] No animals shall be stowed along the alleyways leading to the engine or boil- § 91.24 Attendants. er rooms unless the sides of said engine It shall be the responsibility of the or boiler rooms are covered by a tongue captain of the ocean vessel to carry at and groove tight sheathing producing a least three men on board the vessel 3-inch-wide air space except that on who are experienced in the handling of ships powered with internal combus- the kind/kinds of livestock to be car- tion engines this sheathing may not be ried, and a sufficient number of attend- required at the discretion of the inspec- ants, satisfactory to the inspector or tor. the APHIS veterinarian at the port embarkation to insure proper care of the [42 FR 28990, June 7, 1977. Redesignated at 45 animals: Provided, however, That only FR 86413, Dec. 31, 1980] one person experienced in the handling § 91.23 Loading ramps and doors. of the kind/kinds of livestock to be carried and a sufficient number of attend- (a) Ramps connecting one deck of a ants, satisfactory to the APHIS veteri- ship to another shall have a clear narian at the port of embarkation, to width of 3 feet and a clear height of not insure proper care of the animals must less than 6 feet 6 inches. The incline of be carried on board the ocean vessel if the ramps shall not exceed 1:2 (261⁄2°) less than 800 head of livestock are car- between the ramps and the horizontal ried. plane. The ramps shall be fitted with footlocks of approximately 2″×2″ lum- [42 FR 28990, June 7, 1977, as amended at 43 ber and spaced no more than one foot FR 27171, June 23, 1978. Redesignated at 45 FR 86413, Dec. 31, 1980, and amended at 57 FR apart. The ramps shall have side fenc- 23047, June 1, 1992] ing not less than 5 feet in height. Side doors in ship’s shell plating through § 91.25 Space requirements for animals which livestock are to be loaded shall on ocean vessels. have a height of not less than 6 feet for (a) General requirements. A general cattle and 6 feet 6 inches for horses. space requirement for any individual (b) Alleyways running fore and aft on animal in stalls or crates on ocean ves- the ocean vessel that are used for feed- sels shall be six inches more in height, ing, watering, and loading animals, in- depth, and width than the measure- cluding horses in box stalls, shall have ments of the animal concerned. The a minimum width of 3 feet. However, number of animals in each stall, pen or for a distance not to exceed 8 feet at other container, the cubic inches of air the end of alleyways in the bow and the available for each animal, and the ven- stern of ship, and where obstructions of tilation capability of the transporting less than 3 feet in length occur, the carrier are other criteria used to deter- width may be reduced to a minimum of mine final space requirements for each animal. Guidelines of space require- 8 Deck height is the height from the ceiling ments for storage of animals in pens to the floor. are listed in paragraphs (b) and (c) of

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this section. Final determination of Space in space needed and manner of loading of square feet allowed per animals for export shipment will be animal— made by the inspector or the APHIS 1,400 ...... 22.7 veterinarian at the port of embar- 1,450 ...... 23.3 kation, based upon the size and type of 1,500 ...... 24.0 animals presented, weather, destina- 1,550 ...... 24.6 tion, route, and means of transpor- 1,600 ...... 25.3 1,650 ...... 25.9 tation employed for the export ship- 1.700 ...... 26.6 ment. 1,750 ...... 27.2 (b) Space guidelines: 1,800 ...... 27.8

Space in (c) Space guidelines for containers. square feet allowed per Containers used aboard containerized animal— ocean vessels measure 8 feet in width Animal weight, pounds: outside but vary from 7 feet 3 inches to 100 ...... 4.0 7 feet 9 inches in width inside and from 150 ...... 5.0 17 feet to 40 feet in length. For such 200 ...... 6.0 250 ...... 6.9 containers the space requirements and 300 ...... 7.9 minimum pen widths shown in the fol- 350 ...... 8.9 lowing charts shall be used whenever 400 ...... 9.9 450 ...... 10.9 the length of the animal exceeds the 500 ...... 11.8 width of the container. For ready 550 ...... 12.5 measurement of dairy cattle only, the 600 ...... 13.2 650 ...... 13.9 distance from the withers to the pin 700 ...... 14.6 bone multiplied by 1.65 gives the ap- 750 ...... 15.3 proximate total length. Length of 800 ...... 15.9 other cattle and large animals will re- 850 ...... 16.6 900 ...... 17.3 quire measurement of their total 950 ...... 17.8 length. Other animals larger than 1,000 ...... 18.4 those shown in the following charts 1,050 ...... 18.9 1,100 ...... 19.4 shall be stowed subject to the approval 1,150 ...... 19.9 of the inspector or the APHIS veteri- 1,200 ...... 20.4 narian at the port of embarkation. 1,250 ...... 21.0 1,300 ...... 21.5 Maximum inside length of container 1,350 ...... 22.0 pens shall be 12 feet 9 inches.

3 head 4 head Weight Square feet per head Square feet Width Square feet Width

CONTAINERS 7′9″ IN WIDTH

800 18.5 ...... 74.0 9′7″ 850 19.5 ...... 78.0 10′1″ 900 20.4 61.2 7′11″ 81.6 10′6″ 950 21.4 64.2 8′4″ 85.6 11′1″ 1,000 22.4 67.5 8′9″ 90.6 11′7″ 1,050 23.4 70.2 9′1″ 93.6 12′1″ 1,100 24.5 73.5 9′6″ 98.0 12′8″ 1,150 25.5 76.2 9′10″ ...... 1,200 26.5 79.5 10′3″ ...... 1,250 27.4 82.2 10′6″ ...... 1,300 28.4 85.2 11′0″ ...... 1,350 29.6 88.8 11′6″ ...... 1,400 30.8 92.4 12′0″ ...... 1,450 31.9 95.7 12′4″ ...... 1,500 32.9 98.7 12′9″ ......

CONTAINERS 7′3″ IN WIDTH

700 16.3 ...... 65.2 9′9″ 750 17.5 52.2 7′3″ 70.0 9′8″ 800 18.9 56.7 7′9″ 75.6 10′5″ 850 20.1 60.3 8′3″ 80.4 11′1″ 900 21.3 63.9 8′9″ 85.2 11′9″

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3 head 4 head Weight Square feet per head Square feet Width Square feet Width

950 22.3 66.9 9′2″ 89.2 12′4″ 1,000 23.7 71.1 9′8″ ...... 1,050 24.8 74.1 10′1″ ...... 1,100 26.0 78.6 10′9″ ...... 1,150 27.1 81.3 11′3″ ...... 1,200 28.4 85.5 11′10″ ...... 1,250 29.6 88.8 12′3″ ...... 1,300 30.9 92.7 12′9″ ......

(d) Special requirements. If an animal disabled aboard ship. The number of to be loaded on an ocean vessel is in such stalls shall be as follows: One for the third trimester of pregnancy or the the first 4 to 10 horses shipped, another route of the carrier will be into or for any number in excess of 10 up to through a tropical area, 9 the space re- and including 25, and still another for quired for each animal shall be in- each additional 25 horses or fraction creased by 10 percent. If the animal to thereof. be exported is in the third trimester of (f)(1) Except as provided in paragraph pregnancy and the route of the vessel (c) of this section, space in pens on will be into or through such area, the ocean vessels for cattle weighing 1000 space required for such animal shall be pounds or more shall be no less than 8 increased by 20 percent. (See also para- feet in width and 6 feet 3 inches from graph (g). In addition, hospital pens roof or beams overhead to flooring measuring not less than 3 feet by 8 feet underfoot, except that when floors are for each animal shall be provided at raised over pipes and similar obstruc- the rate of 3 such pens for each 100 tions, a height of not less than 6 feet head loaded, except as provided for may be permitted at the discretion of horses in paragraph (e) of this section. the inspector. Pens for cattle weighing (e) Size of stalls or pens for horses on less than 1,100 pounds may not exceed ocean vessels. Space for horses in pens 226 square feet. Pens for cattle weigh- on ocean vessels shall not be less than ing 1,100 pounds or more may not ex- 6 feet 6 inches from roof or beams over- ceed 610 square feet. When any such head to floor underfoot. Space con- pen includes stanchions, sounding taining up to 120 square feet may be tubes, ventilators, and other obstruc- used for stowage of horses and shall be tions, 20 percent more space for each at least 8 feet but not more than 9 feet animal shall be required. in width (thwartship) except that upon (2) Single stalls in ocean vessels for approval of the inspector or the APHIS cattle weighing 1000 pounds or more veterinarian at the port of embar- shall be not less than 8 feet in length kation, pens 7 feet wide may be allowed by 3 feet in width. for medium-sized horses. Single stalls (3) Calves and yearlings may be shall be not less than 21⁄2 feet wide. stowed in pens or stalls at the discre- Mares in foal shall be shipped only in tion of the inspector or the APHIS vet- separate stalls which shall be not less erinarian at the port of embarkation. than 8 feet long by 3 feet wide and for (g) Space for sheep, goats, and swine on mares due to foal en route and for stal- ocean vessels. Space for sheep, goats, lions, stalls shall not be less than 8 feet and swine on ocean vessels shall not be long by 5 feet wide and shall be readily less than 3 feet in height and the accessible to ship personnel. Extra length and width of pens shall not ex- stalls suitably located shall be proceed 15×8 feet. An increase of 50 percent vided in each compartment or on decks square footage shall be required for where horses are carried so that ade- animals in the third trimester of preg- quate hospital space can be made avail- nancy, notwithstanding other provi- able for any horses that become sick or sions in paragraph (d). [42 FR 28990, June 7, 1977. Redesignated and 9 The area situated between the Tropic of amended at 45 FR 86413, Dec. 31, 1980; 53 FR Cancer and the Tropic of Capricorn. 40407, Oct. 17, 1988; 57 FR 23047, June 1, 1992]

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§ 91.26 Concrete flooring. with nails of a length that will permit (a) Pens aboard an ocean vessel shall 1 inch clinch in 1 inch flooring and 2 have a 3 inch concrete pavement, pro- inch penetration in 2 inch flooring. portioned and mixed to give 2000 psi. (2) Sheep, goats, and swine. Footlocks compressive strength in 28 days. The in pens for sheep, goats, and swine ″× ″ pavement shall have a broom or rough shall be of not less than 1 2 lumber, finish. Steel angle bars may be used for four to each pen, equally distributed footlocks if they are mounted into the and laid in the manner prescribed in flooring in such a way that, at the paragraph (c)(1) of this section for same time, the bars serve as horses and cattle. gutterways. The angle bars shall not be [42 FR 28990, June 7, 1977. Redesignated at 45 less than 2 inches by 2 inches and 5⁄16 FR 86413, Dec. 31, 1980, and amended at 57 FR inches in thickness, and spaced on 12 23047, June 1, 1992] inch centers running for and aft on the vessel. § 91.27 Troughs and hayracks. (b)(1) Horses and cattle. Flooring shall All stalls and pens aboard an ocean be laid athwartship and secured by vessel shall be equipped with proper placing ends beneath the under side of troughs for feeding and watering ani- foot and rump boards or under a 2″×4″ mals as provided in this section. Racks strip nailed along these boards. Floors or nets furnished for feeding hay shall may be either of two types, flush or be of a type acceptable to the inspec- raised. The flush type shall be con- tor. The feeding of hay to the animals structed of not less than 1″ thick lum- on ocean vessels may be by means of ber laid flat on the deck. The raised dispensing the hay from racks or nets type shall be constructed of not less or by placing the hay on the floor of than 2″ thick lumber nailed to the pens in which the animals are con- ″× ″ scantlings of at least 2 3 dimensions fined. laid 2 feet 6 inches apart. If desired, (a) Horses and cattle. Troughs may be flooring may be laid in portable sec- constructed of metal or wood and may tions. Flooring will not be required on be either removable or fixed. The space ships with wooden decks provided between the first footlock and foot- footlocks are secured to the decks. Ce- board may be utilized for feeding cat- ment or composite material diagonally tle, provided a 2″×4″ piece of lumber is scored one-half inch deep may be used affixed along the top surface of said on iron decks instead of wooden floor- footlock so that it, together with the ing if the footlocks are molded in the footboard and the battens, will form an same and bolted to the deck. enclosure. If wooden troughs are used (2) Sheep, goats, and swine. Flooring for feeding, an adequate supply of for sheep, goats, and swine shall be the buckets or other metal containers shall same as prescribed in this section for be provided for the proper watering of horses and cattle, except that the the animals. raised flooring need not be greater (b) Sheep, goats, and swine. Pens for than 12 inch in thickness. these animals shall have feed troughs (3) Drainage. Provisions shall be made not less than 8 inches wide and shall be for drainage of urine and surface water equipped with proper receptacles for from all parts of the vessel used for watering. Pens for sheep and goats carriage of animals including sufficient shall also have ample hayracks suit- scuppers. A walkway shall provide easy able for these animals. access to the scuppers. (c)(1) Horses and cattle. In pens for [42 FR 28990, June 7, 1977. Redesignated at 45 horses or cattle, there shall be four FR 86413, Dec. 31, 1980] footlocks of 1″×4″ lumber laid fore and aft with flat side down, and so placed § 91.28 Stanchions and rails. as to provide in-between spaces of 12, (a)(1) Pipes used for stanchions and 14, 26, and 14 inches, beginning at in- rails for pens aboard an ocean vessel side of the footboard. Additional shall be made of zinc coated, galva- footlocks shall be added at 14 inch in- nized, extra strong, medium carbon tervals in pens having a depth of 9 feet steel. Steel pipes or other steel profiles or more. They shall be well secured shall consist of not less than 4 pipes or

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profiles, the upper one to have 3 inch spector. Information concerning the diameter and the others a diameter of modifications shall be made available not less than 21⁄2 inches. Stanchions to APHIS, at its request. On open rail shall not be of less than 31⁄2 inches di- ships, spaces between the rails shall be ameter; shall not be of less than 5⁄16 blocked out to permit the affixing of inch thickness and shall not be placed outside planking. If supplementary more than 8 feet apart center to center. stanchions are required for rump (2) Threaded pipe connections shall boards, these shall not be less than not be used. All parts shall be cut from 3″×4″ in size and shall be secured to factory fabricated, seamless pipe. beams and decks as outlined above. On (3) Bolt and pin holes shall not be upper deck fittings at ends of unpro- drilled to more than 1⁄32 inch oversize. tected stalls, a stanchion not less than Holes shall be properly located and 3″×4″ in size shall be similarly spaced centered on pipe. and secured to beams and decks and (4) Pipe shall not be deformed or properly braced. Stanchions on weakened by welding such items as re- underdecks shall be constructed, inforcing rods or hinges thereto. Weld- spaced, and secured in the same man- ing shall be used for such attachment ner as upper deck fittings. to be exposed in the finished work. (2) Sheep, goats, and swine. Stan- Pins, plates, and parts other than pipe chions for single or double tier pens for shall be made of galvanized steel. All sheep, goats, and swine shall be con- areas where galvanizing of the steel structed of not less 3″×4″ lumber set at has eroded or has been damaged shall not greater distance than 5 feet on cen- be finished with a rust preventative. ters and secured as outlined in para- (5) Pipe rails shall be placed in proper graph (d)(1). alignment with tops of all gates at the (e) For all animals, two beams of same height. 2″×6″ lumber shall be bolted on each (b) All gates of animal pens aboard side of the stanchions using 5⁄8 inch an ocean vessel shall have smooth fin- bolts, nuts, and washers. Beams shall ished surfaces and the pivot-pins shall extend from outside planking to at have a minimum diameter of 3⁄4 inch. least 2 feet beyond the line of the (c) Animals may be carried on upper breast boards unless the beams butt on decks of an ocean vessel in space abut- the ship’s deck fittings. Two beams of ting the outside rails or bulwarks only 2″×6″ lumber shall be used to support if such rails or bulwarks are 3 feet or the roof of single tier pens on exposed more in height from the deck and are decks and the floor of double tier pens of sufficient strength to hold the nec- on all decks. essary fittings securely or if the space (f) All pens for carrying animals on available is sufficient to permit secur- exposed decks aboard an ocean vessel ing the required fittings to provide the shall be roofed with not less than 1 necessary strength. When animals are inch thick, watertight lumber extend- carried on upper decks, bulkheads shall ing from outside planking to at least 2 be erected at all unprotected ends of feet beyond the line of breast boards: stalls. Provided, That, if tongue and grooved (d)(1) Cattle and horses. Rail stan- lumber is used, it must be caulked or chions for pens aboard an ocean vessel covered so that it is watertight or if for cattle or horses shall be con- square edged lumber is used it shall be structed of not less that 4″ or 6″ lumber covered with a saturated roofing paper set 5 feet apart on centers secured to known to the trade as 30 pound roofing the ship’s rail or bulwark with 5⁄8 inch paper and shall be securely battened. or larger bolts or collars and with heels (g) All pens for carrying animals on raced to the sheer streak or waterway. exposed decks shall be provided with Inboard stanchions of 4″×6″ lumber outside planking of not less than 11⁄2 shall be set in line with the rail stan- inch tongue and groove lumber, laid chions and properly braced: Provided, fore and aft of ship, driven tightly to- however, That the method of securing gether and securely nailed to backs of and bracing of stanchions may be stanchions in a manner to cover all modified as approved by the under- open spaces properly. However, during writer of the cargo bureau, and the in- warm weather the top course planking

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may be left off in order to allow a free into pens or removal therefrom and for circulation of air. On vessels with feeding or watering. closed bulwarks, the outside planking (i)(1) Horses and cattle. Rump boards shall extend not less than 6 inches in pens for horses or cattle shall form below the upper edge of the bulwark. a solid wall at least 4 feet high for cat- (h)(1) Horses. All stalls and pens for tle and 4 feet 6 inches high for horses horses shall be equipped with breast and shall be of lumber not less than 11⁄2 boards of no less than 2″×10″ dressed inches thick if tongued and grooved or lumber with the top edge placed 3 feet 2 inches thick if square edged or of ply- 10 inches from the floor and securely wood of the same strength. Where the nailed to the stanchions. Where deck is clear of obstructions, rump butting occurs, the joints are to be on boards may be set on the inside of the the stanchions and shall be covered rail stanchions. When this is not pos- with metal plates 3 inches square or 5 sible, sections so affected may be inches in diameter and not less than 1⁄4 brought forward to clear such obstruc- inch in thickness. A 5⁄8 inch bolt shall tions and shall be fastened by stan- then be passed through the plate, joint, chions provided for this purpose. On and stanchion and securely fastened lower decks where the ship’s construc- with a nut. All breast boards shall have tion so justifies, rump boards may be 1 inch holes bored through them at affixed to 2″×6″ wooden pieces set the proper distances for tying animals. An same as prescribed for stanchions. occasional pen shall be provided with a Rump boards may be formed by filling removable breast board in order that spaces between cargo battens. Rump animals may be loaded into and re- boards in stalls or pens built alongside moved from the stalls and pens. All hatches need be carried down only to stalls and pens shall be provided with the coaming line. foot boards of not less than 2″×10″ lum- (2) Sheep, goats, and swine. Pens for ber securely nailed or bolted to the sheep, goats, and swine on all exposed stanchions. At the discretion of the in- decks shall be provided with rump spector, small ponies, asses, small boards of the specified size built to a mules, mares with foal at foot, young height of 2 feet 6 inches. unbroken horses or gentle horses of (j)(1) Horses and cattle. Division any size may be stowed loose in pens. boards in pens for horses and cattle In these cases, a sufficient number of shall be used to separate all stalls and finished 2″×10″ lumber shall be placed pens and to close the sides thereof at between the breast and foot boards to the ends of rows. They shall be used in effectively contain the animals. sets of four boards of 2″×10″ dressed (2) Cattle. All stalls and pens for cat- lumber separated by 3 inch spacers, tle shall be provided with boards as re- shall extend from the rump boards to quired for horses in paragraph (a), ex- the inboard stanchions, and shall be cept that the front or breast boards fitted into appropriate channels or shall be constructed in sets of three or slots at both ends in a manner that more boards of 2″×10″ dressed lumber will permit their ready removal. separated by 3 inch spacers and placed (2) Sheep, goats, and swine. Division on the foot board so that the front of boards and those forming ends of pens the pen extends 48 inches or more in for sheep, goats, and swine shall be the height from the floor. One or more of same as prescribed for rump boards for the breast boards may be left off if feed these animals in paragraph (i) of this or water troughs are to be mounted ex- section. ternally. [45 FR 28990, June 7, 1977. Redesignated at 45 (3) Sheep, goats, and swine. Front FR 86413, Dec. 31, 1980, and amended at 57 FR boards in pens for sheep, goats, and 23047, June 1, 1992] swine shall be of not less than 1″×6″ pieces of lumber approximately spaced § 91.29 Hatches. and extending to the proper height for (a) Animals may be placed on hatches these species of animals. Provision on exposed decks on an ocean vessel if shall be made for removing a section of the pens or stalls are securely lashed front boards to allow entry of animals down.

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(b) Animals may be placed on hatches that creates an aerosol or mist that on underdecks on an ocean vessel pro- covers 100 percent of the surfaces in the vided the height requirements of § 91.25 stowage area, except for any loaded (e) and (f) are met and sufficient space cargo and deck surface under it that, in shall be left clear on such hatches for the opinion of the inspector, do not passageway across ship. contain materials that may contain (c) On all hatches on which animals animal disease pathogens such as gar- are carried and under which hay and bage, soil, manure, plant materials, in- feed or animals are stowed, sufficient sects, waste paper, or debris. After space shall be left clear for the proper cleaning and disinfection is performed, removal and handling of such hay and the inspector shall sign and deliver to feed and animal carcasses. Such hatch- the captain of the aircraft or other rees shall be watertight. sponsible official of the airline in- [42 FR 28990, June 7, 1977. Redesignated at 45 volved, a document stating that the FR 86413, Dec. 31, 1980] aircraft has been properly cleaned and disinfected, and stating further the § 91.30 Defective fittings. date, the carrier, the flight number, If previously used fittings aboard an and the name of the airport and the ocean vessel are employed, any portion city and state in which it is located. If thereof found by the inspector to be an aircraft is cleaned and disinfected worn, decayed, unsound, or otherwise at one airport, then flies to a subse- defective shall be replaced. quent airport, with or without stops en route, to load animals for export, the [42 FR 28990, June 7, 1977. Redesignated at 45 inspector at the subsequent airport FR 86413, Dec. 31, 1980] will determine, based on examination of the cleaning and disinfection docu- Subpart E—Cleaning and ments, whether the previous cleaning Disinfecting of Aircraft and disinfection is adequate or whether to order a new cleaning and disinfec- § 91.41 Cleaning and disinfecting of tion. If the aircraft has loaded any aircraft. cargo in addition to animals, the in- Prior to loading of animals, the stow- spector at the subsequent airport will age area of aircraft to be used to export determine whether to order a new animals under the provisions of this cleaning and disinfection based on both part shall, under the supervision of an examination of the cleaning and dis- inspector, be cleaned and then disinfection documents and inspection of infected using a freshly prepared solu- the stowage area for materials that tion of 4 percent sodium carbonate plus may contain animal disease pathogens 0.1 percent sodium silicate. In addition, such as garbage, soil, manure, plant all loading ramps, fittings, and equip- materials, insects, waste paper, or de- ment to be used in loading the animals bris. on the aircraft shall be cleaned and disinfected using an approved disinfectant [53 FR 51747, Dec. 23, 1988] listed in § 71.10 of this chapter. The time at which the cleaning and dis- PART 92—IMPORTATION OF ANI- infection is performed must be ap- MALS AND ANIMAL PRODUCTS: proved by the inspector, who will give PROCEDURES FOR REQUESTING approval only if he or she determines RECOGNITION OF REGIONS that the cleaning and disinfection will be effective up to the projected time of Sec. loading of animals. If the animals are 92.1 Definitions. not loaded by the projected time, the 92.2 Application for recognition of the ani- inspector shall determine whether fur- mal health status of a region. ther cleaning and disinfection are nec- 92.3 Movement restrictions. essary. The cleaning must remove all 92.4 Reestablishment of a region’s disease- garbage, soil, manure, plant materials, free status. insects, paper, and other debris from AUTHORITY: 7 U.S.C. 1622 and 8301–8317; 21 the stowage area. The disinfectant so- U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, lution must be applied with a device 2.80, and 371.4.

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SOURCE: 62 FR 56012, Oct. 28, 1997, unless the United Kingdom (England, Scot- otherwise noted. land, Wales, the Isle of Man, and Northern Ireland). § 92.1 Definitions. Import (imported, importation) into the Active surveillance. Sample collection United States. To bring into the terri- using a systematic or statistically de- torial limits of the United States. signed survey methodology to actively Passive surveillance. A surveillance seek out and find cases of animals with system that does not depend on active a restricted disease agent, or to deter- participation by the responsible agency mine the prevalence of the restricted to seek out and monitor a restricted disease agent in the population. disease agent. The system relies on Adjacent region. Any geographic land mandatory reporting, a pool of trained area, whether or not identifiable by ge- investigators, diagnostic submission ological, political or surveyed bound- procedures and laboratory support, and aries, that shares common boundaries periodic public information and con- with any region. tinuing education programs on dis- Administrator. The Administrator of eases. the Animal and Plant Health Inspec- Prevalence. The number of cases of a tion Service or any other employee of disease in existence at a given time in the Animal and Plant Health Inspec- a designated area. tion Service, United States Depart- Region. Any defined geographic land ment of Agriculture, delegated to act region identifiable by geological, polit- in the Administrator’s stead. ical or surveyed boundaries. A region Animal and Plant Health Inspection may consist of any of the following: Service (APHIS). The Animal and Plant (1) A national entity (country); Health Inspection Service of the United (2) Part of a national entity (zone, States Department of Agriculture. county, department, municipality, par- Animals. All species of the animal ish, Province, State, etc.); kingdom, except man, including: Cat- (3) Parts of several national entities tle, sheep, goats, other ruminants, combined into an area; or swine, horses, asses, mules, zebras, (4) A group of national entities (coun- dogs, poultry, and birds that are sus- tries) combined into a single area. ceptible to communicable diseases of Restricted disease agent. Any commu- livestock and poultry or capable of nicable disease agent or its vector not being carriers of those diseases or their known to exist in the United States or arthropod vectors. that is subject to a Federal or coopera- Communicable disease. Any contagious tive Federal/State control or eradi- or infectious disease of animals. It can cation program within the United be transmitted either directly or indi- States. rectly to a susceptible animal from an Surveillance. Systems to find, mon- infected animal, vector, inanimate itor, and confirm the existence or ab- source, or other sources. sence of a restricted disease agent or Contagious disease. Any commu- agents in livestock, poultry and other nicable disease transmitted from one animals. Surveillance may be passive animal to another by direct contact or or active. by feed, water, aerosol, or contami- United States. All of the States of the nated objects. United States, the District of Colum- Disease agent. A virus, bacterium, or bia, Guam, the Northern Mariana Is- other organism that causes disease in lands, Puerto Rico, the Virgin Islands animals. of the United States, and all other ter- European Union. The organization of ritories and possessions of the United Member States consisting of Austria, States. Belgium, Bulgaria, Cyprus, the Czech Vector-borne disease. A disease trans- Republic, Denmark, Estonia, Finland, mitted to an animal through an inter- France, Germany, Greece, Hungary, mediate arthropod vector, including Italy, Latvia, Lithuania, Luxembourg, ticks or insects. Malta, the Netherlands, Poland, Por- [62 FR 56012, Oct. 28, 1997, as amended at 68 tugal, Romania, Slovakia, Slovenia, FR 16938, Apr. 7, 2003; 72 FR 67232, Nov. 28, Republic of Ireland, Spain, Sweden, and 2007]

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§ 92.2 Application for recognition of information about the region. More de- the animal health status of a region. tailed information regarding the spe- (a) The representative of the national cific types of information that will en- government(s) of any country or coun- able APHIS to most expeditiously con- tries who has the authority to make duct an evaluation of the request is such a request may request that APHIS available at http://www.aphis.usda.gov/ recognize the animal health status of a importlexport/animals/reglrequest.shtml region.1 Such requests must be made in or by contacting the Director, Sanitary English and must be sent to the Ad- Trade Issues Team, National Center for ministrator, c/o National Center for Import and Export, VS, APHIS, 4700 Import and Export, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD River Road Unit 38, Riverdale, MD 20737. For a region to be considered his- 20737–1231. (Where possible, include a torically free of a disease, the disease copy of the request and accompanying must not have been reported in domes- information in electronic format.) tic livestock for at least the past 25 (b) Requests for recognition of the years and must not have been reported animal health status of a region, other in wildlife for at least the past 10 than requests submitted in accordance years. with paragraph (c) of this section, must (1) Scope of the evaluation being re- include, in English, the following infor- quested. mation about the region. More detailed (2) Veterinary control and oversight. information regarding the specific (3) Disease history and vaccination types of information that will enable practices APHIS to most expeditiously conduct (4) Disease notification. an evaluation of the request is avail- (5) Disease detection. able at http://www.aphis.usda.gov/ (6) Barriers to disease introduction. importlexport/animals/reglrequest.shtml (d) A list of those regions that have or by contacting the Director, Sanitary requested APHIS’ recognition of their Trade Issues Team, National Center for animal health status, the disease(s) Import and Export, VS, APHIS, 4700 under evaluation, and, if available, the River Road Unit 38, Riverdale, MD animal(s) or product(s) the region wish- 20737. es to export, is available at http:// (1) Scope of the evaluation being re- www.aphis.usda.gov/importlexport/ani- quested. mals/reglrequest.shtml. (2) Veterinary control and oversight. (e) If, after review and evaluation of (3) Disease history and vaccination the information submitted in accord- practices. ance with paragraph (b) or (c) of this (4) Livestock demographics and section, APHIS believes the request traceability. can be safely granted, APHIS will indi- (5) Epidemiological separation from cate its intent and make its evaluation potential sources of infection. available for public comment through (6) Surveillance. a document published in the FEDERAL (7) Diagnostic laboratory capabili- REGISTER. ties. (f) APHIS will provide a period of (8) Emergency preparedness and re- time during which the public may com- sponse. ment on its evaluation. During the (c) Requests for recognition that a comment period, the public will have region is historically free of a disease access to the information upon which based on the amount of time that has APHIS based its evaluation, as well as elapsed since the disease last occurred the evaluation itself. Once APHIS has in a region, if it has ever occurred, reviewed all comments received, it will must include, in English, the following make a final determination regarding the request and will publish that determination in the FEDERAL REGISTER. 1 Additionally, APHIS may choose to ini- (g) If a region is granted animal tiate an evaluation of the animal health status of a foreign region on its own initiative. health status under the provisions of In such cases, APHIS will follow the same this section, that region may be reevaluation and notification procedures set quired to submit additional informa- forth in this section. tion pertaining to animal health status

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or allow APHIS to conduct additional APHIS will take into consideration the information collection activities in standards of the World Organization order for that region to maintain its for Animal Health (OIE) for reinstate- animal health status. ment of disease-free status, as well as all relevant information obtained (Approved by the Office of Management and Budget under control number 0579–0219) through public comments or collected by or submitted to APHIS through [62 FR 56012, Oct. 28, 1997, as amended at 68 other means. FR 50054, Aug. 20, 2003; 77 FR 1389, Jan. 10, (2) Prior to taking any action to re- 2012; 77 FR 44109, July 27, 2012] lieve prohibitions or restrictions, § 92.3 Movement restrictions. APHIS will make information regarding its reassessment of the region’s dis- Whenever the European Commission ease status available to the public for (EC) establishes a quarantine for a dis- comment. APHIS will announce the ease in the European Union in a region availability of this information in the the Animal and Plant Health Inspec- FEDERAL REGISTER. tion Service recognizes as one in which (c) Determination. Based on the reas- the disease is not known to exist and sessment conducted in accordance with the EC imposes prohibitions or other paragraph (b) of this section, including restrictions on the movement of ani- comments regarding the reassessment mals or animal products from the quar- information, APHIS will take one of antined area in the European Union, the following actions: such animals and animal products are (1) Publish a notice of its decision to prohibited importation into the United reinstate the disease-free status of the States. region, or a portion of the region; [68 FR 16938, Apr. 7, 2003] (2) Publish a notice of its decision to continue the prohibitions or restric- § 92.4 Reestablishment of a region’s tions on the imports of animals and disease-free status. animal products from that region; or This section applies to regions that (3) Publish another document in the are designated under this subchapter as FEDERAL REGISTER for comment. free of a specific animal disease and then experience an outbreak of that [77 FR 1389, Jan. 10, 2012] disease. (a) Interim designation. If a region rec- PART 93—IMPORTATION OF CER- ognized as free of a specified animal TAIN ANIMALS, BIRDS, FISH, AND disease in this subchapter experiences POULTRY, AND CERTAIN ANIMAL, an outbreak of that disease, APHIS BIRD, AND POULTRY PRODUCTS; will take immediate action to prohibit REQUIREMENTS FOR MEANS OF or restrict imports of animals and ani- CONVEYANCE AND SHIPPING mal products from that region. The prohibitions or restrictions may be im- CONTAINERS posed on only a portion of the region previously recognized as free of a dis- Subpart A—Birds ease. In these cases, APHIS will inform Sec. the public as soon as possible through 93.100 Definitions. notice in the FEDERAL REGISTER of the 93.101 General prohibitions; exceptions. basis for its decision to prohibit or re- 93.102 Ports designated for the importation strict imports from the smaller area of of birds. that region previously recognized as 93.103 Import permits for birds; and reserva- free. tion fees for space at quarantine facili- (b) Reassessment of the disease situa- ties maintained by APHIS. 93.104 Certificates for pet birds, commercial tion. (1) Following removal of disease- birds, zoological birds, and research free status from all or part of a region, birds. APHIS may reassess the disease situa- 93.105 Inspection at the port of entry. tion in that region to determine wheth- 93.106 Quarantine requirements. er it is necessary to continue the interim prohibitions or restrictions. In CANADA reassessing a region’s disease status, 93.107 Special provisions.

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Subpart B—Poultry 93.310 Quarantine stations, visiting restricted; sales prohibited. 93.200 Definitions. 93.311 Milk from quarantined horses. 93.201 General prohibitions; exceptions. 93.312 Manure from quarantined horses. 93.202 Inspection of certain aircraft and 93.313 Appearance of disease among horses other means of conveyance and shipping in quarantine. containers thereon; unloading, cleaning, and disinfection requirements. 93.314 Horses, certification, and accom- 93.203 Ports designated for the importation panying equipment. of poultry. CANADA 93.204 Import permits for poultry and for poultry test specimens for diagnostic 93.315 Import permit and declaration for purposes; and reservation fees for space horses. at quarantine facilities maintained by 93.316 Horses from Canada for immediate APHIS. slaughter. 93.205 Certificate for live poultry and hatch- 93.317 Horses from Canada. ing eggs. 93.318 Special provisions. 93.206 Declaration and other documents for poultry. CENTRAL AMERICA AND WEST INDIES 93.207 Inspection at the port of entry. 93.208 Articles accompanying poultry. 93.319 Import permit and declaration for 93.209 Quarantine requirements. horses. 93.210 Poultry quarantine facilities. 93.320 Horses from Central America and the 93.211 Quarantine stations, visiting re- West Indies. stricted; sales prohibited. 93.212 Manure from quarantined poultry. MEXICO 93.213 Appearance of disease among poultry 93.321 Import permits and applications for in quarantine. inspection for horses. CANADA 93.322 Declaration for horses. 93.323 Inspection. 93.214 Import permit and declaration for 93.324 Detention for quarantine. poultry. 93.215 Special provisions. 93.325 Horses from Mexico. 93.216 Poultry from Canada. 93.326 Horses for immediate slaughter.

CENTRAL AMERICA AND THE WEST INDIES Subpart D—Ruminants

93.217 Import permit and declaration for 93.400 Definitions. poultry. 93.401 General prohibitions; exceptions. MEXICO 93.402 Inspection of certain aircraft and other means of conveyance and shipping 93.218 Import permits and applications for containers thereon; unloading, cleaning, inspection for poultry. and disinfection requirements. 93.219 Declaration for poultry. 93.403 Ports designated for the importation 93.220 Inspection at port of entry. of ruminants. Subpart C—Horses 93.404 Import permits for ruminants and for ruminant test specimens for diagnostic 93.300 Definitions. purposes; and reservation fees for space 93.301 General prohibitions; exceptions. at quarantine facilities maintained by 93.302 Inspection of certain aircraft and APHIS. other means of conveyance and shipping 93.405 Health certificate for ruminants. containers thereon; unloading, cleaning, 93.406 Diagnostic tests. and disinfection requirements. 93.407 Declaration and other documents for 93.303 Ports designated for the importation ruminants. of horses. 93.408 Inspection at the port of entry. 93.304 Import permits for horses from re- 93.409 Articles accompanying ruminants. gions affected with CEM and for horse 93.410 Movement from conveyances to quar- specimens for diagnostic purposes; res- antine station. ervation fees for space at quarantine fa- 93.411 Quarantine requirements. cilities maintained by APHIS. 93.305 Declaration and other documents for 93.412 Ruminant quarantine facilities. horses. 93.413 Quarantine stations, visiting re- 93.306 Inspection at the port of entry. stricted; sales prohibited. 93.307 Articles accompanying horses. 93.414 Milk from quarantined ruminants. 93.308 Quarantine requirements. 93.415 Manure from quarantined ruminants. 93.309 Horse quarantine facilities; payment 93.416 Appearance of disease among information. ruminants in quarantine.

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CANADA CANADA 93.417 Import permit and declaration for 93.516 Import permit and declaration for ruminants. swine. 93.418 Cattle from Canada. 93.517 Swine from Canada. 93.419 Sheep and goats from Canada. 93.518 Swine from Canada for immediate 93.420 Ruminants from Canada for imme- slaughter. diate slaughter other than bovines, 93.519 Special provisions. sheep, and goats. CENTRAL AMERICA AND WEST INDIES 93.421 Special provisions. 93.520 Import permit and declaration for CENTRAL AMERICA AND WEST INDIES swine.

93.422 Import permit and declaration for MEXICO ruminants. 93.423 Ruminants from Central America and 93.521 Declaration for swine. the West Indies. Subpart F—Dogs MEXICO 93.600 Importation of dogs. 93.424 Import permits and applications for inspection of ruminants. Subpart G—Miscellaneous Animals 93.425 Declaration for ruminants. 93.426 Inspection at port of entry. 93.700 Definitions. 93.701 Prohibitions. 93.427 Cattle from Mexico. 93.702 Restrictions. 93.428 Sheep and goats and wild ruminants 93.703 Ports designated for importation. from Mexico. 93.704 Import permit. 93.429 Ruminants for immediate slaughter. 93.705 Health certificate. 93.706 Notification of arrival. ADDITIONAL GENERAL PROVISIONS 93.707 Inspection at the port of first arrival. 93.430–93.431 [Reserved] 93.432 Cattle from the Republic of Ireland. Subpart H—Elephants, Hippopotami, 93.433–93.434 [Reserved] Rhinoceroses, and Tapirs 93.435 Sheep and goats. 93.800 Definitions. 93.436 Ruminants from regions of minimal 93.801 Prohibitions. risk for BSE. 93.802 Import permit. Subpart E—Swine 93.803 Health certificate. 93.804 Declaration upon arrival. 93.500 Definitions. 93.805 Ports of entry, inspection, and treat- 93.501 General prohibitions; exceptions. ment. 93.502 Inspection of certain aircraft and 93.806 Animals refused entry. other means of conveyance and shipping 93.807 Other importations. containers thereon; unloading, cleaning, and disinfection requirements. Subpart I—Aquatic Animal Species 93.503 Ports designated for the importation 93.900 Definitions. of swine. 93.504 Import permits for swine and for GENERAL PROVISIONS FOR SVC-REGULATED swine specimens for diagnostic purposes; FISH SPECIES and reservation fees for space at quar- 93.901 General restrictions; exceptions. antine facilities maintained by APHIS. 93.902 Ports designated for the importation 93.505 Certificate for swine. of live fish, fertilized eggs, and gametes. 93.506 Declaration and other documents for 93.903 Import permits for live fish, fertilized swine. eggs, and gametes. 93.507 Inspection at the port of entry. 93.904 Health certificate for live fish, fer- 93.508 Articles accompanying swine. tilized eggs, and gametes. 93.509 Movement from conveyances to quar- 93.905 Declaration and other documents for antine station. live fish, fertilized eggs, and gametes. 93.510 Quarantine requirements. 93.906 Inspection at the port of entry. 93.511 Swine quarantine facilities. 93.907–93.909 [Reserved] 93.512 Quarantine stations, visiting restricted; sales prohibited. GENERAL PROVISIONS FOR VHS-REGULATED 93.513 Milk from quarantined swine. FISH SPECIES 93.514 Manure from quarantined swine. 93.910 General restrictions; exceptions. 93.515 Appearance of disease among swine in 93.911 Ports designated for the importation quarantine. of live VHS-regulated fish species.

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93.912 Import permits. Licensed veterinarian. Any person li- 93.913 Health certificate. censed by any region or political sub- 93.914 Declaration and other documents. division thereof to practice veterinary 93.915 Inspection at the port of entry. medicine. 93.916 Special provisions. Pen-raised. Cared for in a fenced en- AUTHORITY: 7 U.S.C. 1622 and 8301–8317; 21 closure, such that the ratites are kept U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, apart from wild ratites, poultry, and 2.80, and 371.4. other animals; can be readily observed, SOURCE: 55 FR 31495, Aug. 2, 1990, unless and be restrained for inspection and otherwise noted. Redesignated at 62 FR 56012, treatment. A flock is not considered to Oct. 28, 1997. be pen-raised if ratites captured in the wild have been added to it after March Subpart A—Birds 8, 1994. Performing or theatrical birds. Birds, § 93.100 Definitions. except ratites, which are to be used in Wherever in this subpart the fol- shows, theatrical acts or performances lowing terms are used, unless the con- only. text otherwise requires, they shall be Persons. Any individual, corporation, construed, respectively, to mean: company, association, firm, partner- Administrator. The Administrator of ship, society or joint stock company. the Animal and Plant Health Inspec- Pet birds. Birds, except ratites, which tion Service or any other employee of are imported for the personal pleasure the Animal and Plant Health Inspec- of their individual owners and are not tion Service, United States Depart- intended for resale. ment of Agriculture, to whom author- Port Veterinarian. A veterinarian em- ity has been or may be delegated to act ployed by the Animal and Plant Health in the Administrator’s stead. Inspection Service to perform duties Animal and Plant Health Inspection required under this part at a port of Service. The Animal and Plant Health entry. Inspection Service of the United States Poultry. Chickens, doves, ducks, Department of Agriculture (APHIS or geese, grouse, guinea fowl, partridges, Service.) pea fowl, pheasants, pigeons, quail, Animals. Cattle, sheep, goats, other swans, and turkeys (including eggs for ruminants, swine, horses, asses, mules, hatching). zebras, dogs, and poultry. Production season. That period of APHIS representative. A veterinarian time, usually approximately 9 months or other individual employed by the each year, from the time ratites in a Animal and Plant Health Inspection flock begin laying eggs until the Service, United States Department of ratites cease laying eggs. Agriculture, who is authorized to per- Ratites. Cassowaries, emus, kiwis, os- form the services required by this part. triches, and rheas. Birds. All members of the class aves Region. Any defined geographic land (including eggs for hatching), other area identifiable by geological, polit- than poultry. ical, or surveyed boundaries. A region Commercial birds. Birds which are im- may consist of any of the following: ported for resale, breeding, public dis- (1) A national entity (country); play, or any other purpose, except pet (2) Part of a national entity (zone, birds, zoological birds, research birds, county, department, municipality, par- or performing or theatrical birds. ish, Province, State, etc.); Communicable disease. Any con- (3) Parts of several national entities tagious, infectious, or communicable combined into an area; or disease of domestic livestock, poultry (4) A group of national entities (coun- or other animals. tries) combined into a single area. Department. The United States De- Research birds. Birds which are to be partment of Agriculture (USDA). used for research purposes only. Inspector. An employee of the Animal Smuggled birds. Any bird which has and Plant Health Inspection Service been brought into the United States authorized to perform duties required contrary to any Federal law or regula- under this subpart. tion and which has been seized by any

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official of any Department of the (b)(1) Birds from Canada may be im- United States Government or which ported in accordance with this section has been abandoned to the United or, except for ratites in accordance States. with the provisions applicable to im- United States. All of the States of the portation of poultry from Canada as United States, the District of Colum- specified in §§ 93.205, 93.214, and 93.216 of bia, Guam, Northern Mariana Islands, this part. Puerto Rico, the Virgin Islands of the (2) Ratites and hatching eggs of United States, and all other Territories ratites may be imported into the and Possessions of the United States. United States only in accordance with Veterinary Services. The Veterinary the provisions in this part that apply Services unit of the Department. to commercial and zoological birds, Zoological birds. Birds intended for and, where specified, with the provi- breeding or public display, for rec- sions that apply to ratites or hatching reational or educational purposes, at a eggs of ratites. zoological park. (3) Except for ratites imported as zo- Zoological park. A professionally oper- ological birds, and ratites and ratite ated zoo, park, garden or other place, hatching eggs imported from Canada in maintained under the constant surveil- accordance with § 93.107, ratites and lance of a Doctor of Veterinary Medi- hatching eggs of ratites may not be im- cine, for the exhibition of live animals, ported into the United States unless pigeons or birds, for the purpose of pub- the following conditions are met: lic recreation or education. (i) The ratites or hatching eggs are produced by a pen-raised flock, and, in [55 FR 31495, Aug. 2, 1990, as amended at 56 FR 31865, July 12, 1991; 59 FR 10732, Mar. 8, the case of ratites, maintained in a 1994; 59 FR 47068, Sept. 14, 1994. Redesignated pen-raised flock; and amended at 62 FR 56012, 56013, Oct. 28, (ii) Each ratite produced in the flock 1997] is identified with an identification number by means of a microchip im- § 93.101 General prohibitions; excep- planted at 1-day of age in the pipping tions. muscle of ostriches and in the upper (a) No product or bird subject to the neck of other ratites, each ratite added provisions of this part shall be brought from outside the flock is identified in into the United States except in ac- like manner upon arrival in the flock, cordance with the regulations in this except that the microchip need not be part and part 94 of this subchapter;1 implanted in the pipping muscle or the nor shall any such product or bird be upper neck, and each ratite already in handled or moved after physical entry the flock as of March 8, 1994 is identi- into the United States before final re- fied in like manner, prior to the next lease from quarantine orany other visit to the flock premises by an form of governmental detention except APHIS representative under in compliance with such regulations; § 93.103(a)(2)(iv), except that the Provided, That the Administrator may microchip need not be implanted in the upon request in specific cases permit pipping muscle or the upper neck; products or birds to be brought into or (iii) On the date it is produced, each through the United States under such hatching egg produced in the flock is conditions as he or she may prescribe, marked in indelible ink with the date when he or she determines in the spe- of the production, and with identifica- cific case that such action will not en- tion, assigned by the national govern- danger the livestock or poultry of the ment of the region of export, of the United States. No live birds, and no premises and region from which the hatching eggs from birds, shall be im- ratites or hatching eggs are intended ported into the United States if the for exportation; birds have been vaccinated for the H5 (iv) The owner or manager of the or H7 subtype of avian influenza. premises from which the ratites or hatching eggs are intended for impor- 1 Importations of certain animals from var- tation into the United States main- ious regions are absolutely prohibited under tains on a daily basis a register listing part 94 because of specified diseases. the following:

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(A) Number of live ratites hatched in the United States establishes a max- the flock or added to the flock, and imum number of hatching eggs of number of live ratites removed from ratites that may be produced on each the flock, and the microchip number premises over a set production season. for each of these ratites; The ceiling for each premises is cal- (B) Number of eggs produced in the culated jointly by a full-time salaried flock and date of production, and num- veterinary officer of the national gov- ber of eggs removed from the flock and ernment of the region of export and the date of production; and APHIS representative who conducts (C) Number of eggs in incubator/ the site visit required under hatcher and date of production; § 93.103(a)(2)(iv), and is adjusted jointly (v) The owner or manager of the by an APHIS representative and a full- premises submits a copy of the reg- time salaried veterinary officer of the isters to the National Veterinary Serv- national government of the region of ice of the region of export on a quar- export according to changes in the terly basis. The region of export in number of laying hens in the flock; turn submits a copy of the registers to (x) The region of export conducts the Administrator upon his or her re- random inspections of each premises quest; 2 intending to export ratites or hatching (vi) The region from which the eggs of ratites to the United States, at ratites or hatching eggs are exported least twice during each production sea- to the United States maintains a reg- son, to ensure that all ratites and istry of premises that wish to export hatching eggs of ratites on the prem- ratites or hatching eggs of ratites to ises are identified as required under the United States, that lists each paragraphs (b)(3)(ii) and (b)(3)(iii) of ratite according to the microchip num- this section. These inspections must be ber required under paragraph (b)(3)(iv) conducted by either a veterinary offi- of this section, and also maintains a cer of the national government of the count of hatching eggs of ratites pro- region of export or an employee of that duced on or added to the premises; government responsible for the protec- (vii) Before a premises is added to the tion of fish and wildlife. If any ratites registry, either a veterinary officer of or hatching eggs are not identified as the national government of the region required, the region of export must not of export, or an employee of that gov- issue the export certificate required ernment responsible for the protection under § 93.104(a). The region of export of fish and wildlife, visits the premises must record, on the copy of the report and determines that all ratites and required to be sent to the Adminis- hatching eggs of ratites are identified trator under paragraph (b)(3)(v) of this as required under paragraphs (b)(3)(ii) section, whether all ratites and hatch- and (b)(3)(iii) of this section. ing eggs are identified as required; (viii) The region from which the (xi) The region of export requires ratites or hatching eggs of ratites are each premises on which ratites or exported to the United States requires hatching eggs of ratites intended for each premises from which ratites or export to the United States are kept to hatching eggs of ratites are exported to the United States to receive approval submit to the National Veterinary from the National Veterinary Service Service of that region a copy of the of that region before ratites are added certificate required under § 93.104(a); to the premises from outside the prem- (xii) The person intending to import ises, and also prohibits the addition of ratites into the United States provides ratites to a flock during production the APHIS veterinary inspector at the seasons; intended port of entry with a reader ca- (ix) The region from which ratites or pable of reading the microchip im- hatching eggs of ratites are exported to planted in each of the ratites. (4) Ratites and hatching eggs of ratites may not be imported into the 2 Copies should be mailed to the Animal and Plant Health Inspection Service, Veteri- United States in any container that nary Services, National Center for Import- holds hay, straw, grasses, wood chips, Export, 4700 River Road Unit 38, Riverdale, sawdust, or other materials likely to Maryland 20737–1231. harbor ectoparasites. Ratites and

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hatching eggs of ratites that are im- (c)(3) of this section, pet birds of ported into the United States in con- United States origin that have been tainers holding such materials will be outside the country for more than 60 refused entry. days may be imported by their owner (c)(1) Pet birds offered for entry from if: Canada and which are not known to be (A) The pet birds are accompanied by affected with or exposed to any com- an import permit issued by APHIS: municable disease of poultry, which are Provided, that an import permit will caged (prior to release from the port of not be required for pet birds returning entry) and which are personal pets, from Canada or Mexico through a land may be imported by the owner thereof border port; and at any port of entry designated in (B) The pet birds are found upon port §§ 93.103 or 93.203: Provided, That, such of entry veterinary inspection to be birds are found upon port of entry vet- free of poultry diseases; and erinary inspection under § 93.105 to be (C) The pet birds are accompanied by free of poultry diseases and at the time a United States veterinary health cer- of entry the owner signs and furnishes tificate issued prior to the departure of to the Administrator, a statement the birds from the United States and stating that the bird or birds have been the certificate shows the number from in his or her possession for a minimum the leg band, tattoo, or microchip af- of 90 days preceding the date of impor- fixed to the birds prior to departure; tation and that during such time such and birds have not been in contact with (D) During port of entry veterinary poultry or other birds (for example, as- inspection it is determined that the sociation with other avian species at number from the leg band, tattoo, or exhibitions or in aviaries.) microchip on the bird is the same as (2)(i) Except for pet birds that have the one listed on the health certificate; been in any region where highly patho- and genic avian influenza exists, which are (E) The owner importing the pet subject to the provisions of paragraph birds signs and furnishes to the Admin- (c)(3) of this section, pet birds of istrator the following: United States origin that have not (1) A notarized declaration under been outside the country for more than oath or affirmation (or a statement 60 days may be offered for entry under signed by the owner and witnessed by a the provisions of paragraph (c)(1) of Department inspector) stating that the this section if: bird or birds have not been in contact (A) The pet birds are accompanied by with poultry or other birds while out of an import permit issued by APHIS: the region (for example, association Provided, that an import permit will with other avian species at exhibitions not be required for pet birds returning or at aviaries); and from Canada or Mexico through a land (2) An agreement on VS Form 17–8, border port; and obtainable from a Federal inspector at (B) The birds are also accompanied the port of entry, stating: by a United States veterinary health (i) That the birds will be maintained certificate issued prior to the depar- in confinement in his or her personal ture of the birds from the United possession separate and apart from all States and the certificate shows the poultry and other birds for a minimum number from the leg band, tattoo, or of 30 days following importation at the microchip affixed to the birds prior to address where the birds are to be held departure; and and made available for health inspec- (C) During port of entry veterinary tion and testing by Department inspec- inspection it is determined that the tors upon request until released at the number from the leg band, tattoo, or end of such period by such an inspec- microchip on the bird is the same as tor; and the one listed on the health certificate. (ii) That appropriate Federal officials (ii) Except for pet birds that have in the State of destination will be im- been in any region where highly patho- mediately notified if any signs of dis- genic avian influenza exists, which are ease are noted in any of the birds or subject to the provisions of paragraph any bird dies during that period. The

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owner importing such birds must com- the certificate was authorized to do so. ply with the provisions of the afore- Certificates in a foreign language must mentioned agreement before the birds be translated into English at the ex- may be released from confinement. Ex- pense of the importer. cept for pet birds that have been in any (ii) An advanced reservation fee as region where highly pathogenic avian required by § 93.103(a)(3) and a request influenza exists, lots of pet birds of for space which has been confirmed in United States origin which do not oth- writing, at a USDA-operated quar- erwise meet the requirements of para- antine facility shall be made with the graphs (c)(1) or (2) of this section may port veterinarian 3 at the port where be offered for entry under the provi- the birds are to be held for a minimum sions of paragraph (c)(4) of this section. 30-day isolation in a biologically secure (3) Any pet birds of United States ori- unit separate and apart from all other gin that have been in any region iden- avian species, except, that birds arriv- tified in accordance with § 94.6(a)(2) of ing without an advanced reservation this subchapter as a region where high- may be handled if an isolation unit is ly pathogenic avian influenza exists, available, provided the reservation fee regardless of the length of time such as required in § 93.103(a)(3) is paid. Pet birds have been outside of the United birds offered for entry at a port of States, may only be imported through entry that has not been designated in the port of Los Angeles, CA, Miami, § 93.102(a), or pet birds arriving without FL, or New York, NY, and only under an advanced reservation at a port of the following conditions: entry designated in § 93.102(a) but at (i) The birds meet the requirements which isolation units are not available, of paragraphs (c)(2)(ii)(A) through (D) shall be refused entry at such port. of this section; and However, such pet birds may be trans- (ii) The birds are quarantined for a ported at the owner’s expense to an- minimum of 30 days, and for such other port of entry designated in longer period as may be required by the § 93.102(a) if available quarantine space Administrator in any specific case, at a exists, if the reservation fee is paid and USDA quarantine facility in accord- the birds are shipped to such other port ance with § 93.106. under conditions deemed sufficient by (4) Pet birds which are not known to the Administrator to prevent the be affected with or exposed to commu- spread of communicable diseases of nicable diseases of poultry may be of- poultry: Provided, That pet birds arriv- fered for entry at one of the ports of ing with or without an advance res- entry designated in § 93.102(a) under the ervation at the port of Hidalgo, Texas, following conditions: will be transported at Department ex- (i) The pet birds shall be accom- pense to the quarantine facility at Mis- sion, Texas, if available quarantine panied by a veterinary health certifi- space exists at that facility, until quar- cate issued by a national government antine facilities are available at Hi- veterinary officer of the region of ex- dalgo, Texas; and pet birds arriving port stating that he or she personally with or without an approved reserva- inspected the birds listed on the health tion entered at the port of New York, certificate and found them to be free of New York, will be transported at De- evidence of Newcastle disease, partment expense to the quarantine fa- chlamydiosis, and other communicable cility at Newburgh, New York, if avail- diseases of poultry, and that the birds able quarantine space exists at the fa- were being exported in compliance cility, until quarantine facilities are with the laws and regulations of the re- available at New York, New York. Fol- gion of export, or if exported from Mex- lowing the isolation period, if such ico, shall be accompanied either by such a certificate or by a certificate issued by a veterinarian accredited by 3 The names and addresses of the port vet- the National Government of Mexico erinarians, as well as a fee schedule for quarantine charges, are available from the Ani- and endorsed by a full-time salaried mal and Plant Health Inspection Service, veterinary officer of the National Gov- Veterinary Services, Operational Support, ernment of Mexico, thereby rep- 4700 River Road Unit 33, Riverdale, Maryland resenting that the veterinarian issuing 20737–1231.

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birds are found to be free from commu- into a bird holding facility which is nicable diseases of poultry, the birds provided by the carrier or its agent and shall be returned at Department ex- has been approved 5 in advance by the pense to the respective ports of Hi- Administrator in accordance with dalgo, Texas, or New York, New York, paragraph (d)(3) of this section as ade- as appropriate, for Agriculture release quate to prevent the spread within the for entry through U.S. Customs. United States of any livestock or poul- (iii) During the isolation period, the try disease, and they are maintained birds shall be subjected to such tests there under continuous confinement and procedures as required by the Ad- until loaded aboard a means of convey- ministrator to determine whether the ance for transportation from the birds are free from communicable dis- United States and are maintained eases of poultry. under continuous confinement aboard (iv) Following the isolation period, if such means of conveyance until it the birds are found to be free of com- leaves the United States; the import municable disease of poultry, the port permit will specify any additional con- veterinarian shall issue an agriculture ditions necessary to assure that the release for entry through U.S. Cus- transit of the poultry or birds through toms. If the birds are found during port the United States can be made without of entry inspection or during quar- endangering the livestock or poultry of antine to be infected with or exposed to the United States, and that Depart- a communicable disease of poultry, ment inspectors may inspect the poul- such birds shall be refused entry and try or birds on board such means of handled in accordance with § 93.106(a) of conveyance or in such holding facility this part. to ascertain whether the requirements (v) The owner of the birds is respon- of this paragraph are met, and dispose sible for all costs which result from of them in accordance with the Animal these procedures and shall reimburse Health Protection Act (7 U.S.C. 8301 et APHIS for governmental expenses in seq.) if such conditions are not met; accordance with § 93.210 (b) and (c) of and this part. (d) The provisions in this subpart re- (2) The carrier or its agent executes lating to birds shall not apply to and furnishes to the collector of Cus- healthy birds, except ratites, not toms at the first port of arrival a dec- known to be infected with or exposed, laration stating that the poultry or within the 90 days preceding the date birds will be retained aboard such of export from the region of origin, to means of conveyance or in an approved communicable diseases of poultry, if an holding facility during transhipment as import permit 4 has been obtained required by this paragraph. under § 93.103 of this chapter and all (3) Provisions for the approval of fa- conditions therein are observed; and if cilities required in this paragraph are: such birds are handled as follows: (i) They must be sufficiently isolated (1)(i) They are maintained under con- to prevent direct or indirect contact tinuous confinement in transit through with all other animals and birds while the United States aboard an aircraft, in the United States. ocean vessel, or other means of convey- (ii) They must be so constructed that ance; or they provide adequate protection (ii) Except for birds in transit against environmental conditions and through Anchorage, Alaska, under can be adequately cleaned, washed and § 93.103(c) of this part, which are not al- disinfected. lowed to be unloaded, they are un- (iii) They must provide for disposal of loaded, in the course of such transit, animal and bird carcasses, manure, bedding, waste and any related ship- 4 Such permit may be obtained from the ping materials in a manner that will Animal and Plant Health Inspection Service, prevent dissemination of disease. Veterinary Services, Operational Support, (iv) They must have provisions for 4700 River Road Unit 33, Riverdale, Maryland adequate sources of feed and water and 20737–1231. Requests for approval of such facilities should also be made to the Deputy Administrator. 5 See footnote 4 in subpart A.

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for attendants for the care and feeding (iii) The owner importing the birds of birds in the facility. signs and furnishes to the Adminis- (v) They must comply with addi- trator the following: tional requirements as may be imposed (A) A notarized declaration under by the Administrator if deemed appli- oath or affirmation (or a statement cable for a particular shipment. signed by the owner and witnessed by a (vi) They must also comply with all Department inspector) stating that the applicable local, State and Federal re- birds have not been in contact with quirements for environmental quality other birds while out of the region (for and with the provisions of the Animal example, association with other avian Welfare Regulations in chapter I of this species at exhibitions or at aviaries); title, as applicable. and (e) Commercial birds, zoological (B) An agreement on VS Form 17–8, birds, research birds, or pet birds may obtainable from a Federal inspector at be imported into the United States if the port of entry, stating: they meet the requirements of (1) That the birds will be maintained §§ 93.102(a), 93.103, 93.104, 93.105(a), and in confinement in his or her personal 93.106(a) which specifically apply to possession separate and apart from all such birds and the requirements of all birds and other birds for a minimum of other sections in this part that are ap- 30 days following importation at the plicable to poultry generally. address where the birds are to be held (f) Performing or theatrical birds re- and made available for health inspec- turning to the United States. (1) Per- tion and testing by Department inspec- forming or theatrical birds of United tors upon request until released at the States origin that are returning to the end of such period by such an inspec- United States from Canada or Mexico tor; and may be imported if: (2) That appropriate Federal officials (i) The birds are found upon port of in the State of destination will be im- entry veterinary inspection to be free mediately notified if any signs of dis- of avian diseases; and ease are noted in any of the birds or (ii) The birds are accompanied by a any birds die during that period. The United States veterinary health certifi- owner importing such poultry must cate issued prior to the departure of comply with the provisions of the the birds from the United States and aforementioned agreement before the the certificate shows the number from birds may be released from confine- the leg band, tattoo, or microchip af- ment. Except for performing or theat- fixed to the birds prior to departure; rical birds that have been in any region and where highly pathogenic avian influ- (iii) During port of entry veterinary enza exists, performing or theatrical inspection it is determined that the birds of United States origin which do number from the leg band, tattoo, or not otherwise meet the requirements of microchip on the birds is the same as paragraphs (f)(1) or (2) of this section the one listed on the health certificate. may be offered for entry under the pro- (2) Except for performing or theat- visions of § 93.101(c). rical birds that have been in any region (3) Any performing or theatrical where highly pathogenic avian influ- birds of United States origin that have enza exists, which are subject to the been in any region identified in accord- provisions of paragraph (f)(3) of this ance with § 94.6(a)(2) of this subchapter section, performing or theatrical poul- as a region where highly pathogenic try of United States origin that have avian influenza exists may only be im- been outside the United States in a reported through the port of Los Angeles, gion other than Canada or Mexico may CA, Miami, FL, or New York, NY, and be imported if: only under the following conditions: (i) The birds meet the requirements (i) The birds meet the requirements of paragraphs (f)(1)(i) through (iii) of of paragraphs (f)(1)(i) through (iii) of this section; and this section; and (ii) The birds are accompanied by an (ii) The birds are accompanied by an import permit issued by APHIS; and import permit issued by APHIS; and

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(iii) The birds are quarantined for a be exposed such birds shall be held in minimum of 30 days, and for such permanent quarantine in accordance longer period as may be required by the with such conditions as the Deputy Ad- Administrator in any specific case, at a ministrator may prescribe to protect quarantine facility maintained by poultry of the United States. At the APHIS in accordance with paragraphs time any smuggled bird enters the (c)(3)(ii) through (c)(3)(iv) of this sec- quarantine facility, it shall be identi- tion. fied in a manner approved by the Ad- (g) Any smuggled bird shall: ministrator. (1) Be refused entry into the United (4) If the laboratory tests for END States and be removed from the United are negative and as determined by the States, 6 or port veterinarian the birds are free of (2) Be quarantined in a USDA-oper- clinical evidence of diseases of poultry ated quarantine facility pending nega- at the end of the quarantine period, the tive results to two consecutive tests port veterinarian shall issue an agri- for exotic Newcastle disease (END) 7 ad- cultural release for entry of the birds ministered not less than 30 days apart, through the United States Customs with the first test administered within Service at the termination of the quar- seven days after the bird enters the fa- antine period. Providing that the sale cility. of the smuggled birds is not contrary (3) Tissue samples from any smuggled to any Federal law or regulation, ex- bird which has died prior to release penses incurred by the Department for from quarantine shall be submitted for the handling of the smuggled birds END isolation. Smuggled birds shall under this paragraph shall be reim- also be subject to such other tests and bursed from funds derived from the sale procedures to determine whether the or disposition of the smuggled birds birds are free from communicable dis- after their release from quarantine. eases of poultry other than END when Any smuggled bird which by law may the port veterinarian determine that not be sold, or so disposed, shall be the bird in question has shown physical quarantined in accordance with such symptoms of being affected with or ex- procedures as the Deputy Adminis- posed to communicable diseases of trator may establish to prevent the in- poultry. A lot of smuggled birds placed troduction of communicable diseases of into the quarantine facility shall be livestock or poultry into the United handled on an ‘‘all-in, all-out’’ basis: States, in accordance with the law. Provided, That birds of endangered and threatened species, as determined by (Approved by the Office of Management and the Department of the Interior (16 Budget under control numbers 0579–0220 and 0579–0245) U.S.C. 1533, as amended) shall be separated for quarantine and testing as sep- [55 FR 31495, Aug. 2, 1990. Redesignated at 62 arate lots. If END or any other commu- FR 56012, Oct. 28, 1997] nicable disease of poultry is diagnosed EDITORIAL NOTE: For FEDERAL REGISTER ci- in any smuggled bird at any point or if tations affecting § 93.101, see the List of CFR it is determined that any smuggled Sections Affected, which appears in the bird has been exposed to END or any Finding Aids section of the printed volume other such communicable disease, such and at www.fdsys.gov. birds shall not be released from quar- § 93.102 Ports designated for the im- antine and shall be disposed of in ac- portation of birds. cordance with procedures established by the Administrator to prevent the (a) Special ports for pet birds. The fol- entry of communicable diseases of live- lowing ports are designated as ports of stock or poultry into the United entry for pet birds imported under the States. However, if endangered or provisions of § 93.101(c) and performing threatened species are determined to or theatrical birds imported under the provisions of § 93.101(f): Los Angeles and San Ysidro, CA; Miami, FL; New York, 6 Birds that would require handfeeding will be refused entry. NY; Baudette, MN; and Hidalgo, TX. 7 Such tests are conducted according to the (b) Designation of other ports. The Sec- Protocol for END which is available upon re- retary of the Treasury has approved quest from the Administrator. the designation as quarantine stations

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of the ports specified in this section. In tion 8 must include the following infor- special cases other ports may be des- mation: ignated as quarantine stations under (i) The name, address, and telephone this section by the Administrator, with number of the importer; the concurrence of the Secretary of the (ii) The status of the importer, such Treasury. as individual, partnership, or corpora- (c) Notwithstanding any other provi- tion (if incorporated, include State sions of this section, all commercial where incorporated and date of incor- birds, zoological birds, or research poration); birds shall be imported only at a port (iii) Name and address of the quar- of entry specified in § 93.105. antine facility; (d) Limited ports. The following ports (iv) Date of intended quarantine; are designated as ports of entry for pet (v) The purpose of the importation; birds imported under the provisions of (vi) The region of origin; § 93.101(c)(1) or (2) and performing or (vii) The name and address of the ex- theatrical birds imported under the porter; provisions of § 93.101(f): Anchorage and (viii) The port of embarkation in the Fairbanks, AK; San Diego, CA; Jack- foreign region; sonville, Port Canaveral, St. Peters- (ix) The mode of transportation, burg-Clearwater, and Tampa, FL; At- route of travel, and port of entry in the lanta, GA; Honolulu, HI; Chicago, IL; United States; New Orleans, LA; Baltimore, MD; Port- (x) The name and location of the land, ME; Minneapolis, MN; Great quarantine facility in the United Falls, MT; Covington, KY (Greater Cin- States to which delivery will be made cinnati International Airport); Port- from the port of entry, in accordance land, OR; San Juan, PR; Galveston and with § 93.106(c)(5); Houston, TX; and Seattle, Spokane, (xi) A drawing of the floor plan for and Tacoma, WA. the facility showing the location of the [55 FR 31495, Aug. 2, 1990, as amended at 59 bird holding area; equipment storage FR 36026, July 15, 1994; 60 FR 16045, Mar. 29, areas; office areas; clothes storage and 1995; 60 FR 25120, May 11, 1995; 61 FR 68125, change areas; feed storage areas; ne- Dec. 27, 1996. Redesignated and amended at 62 cropsy areas (showing entry and refrig- FR 56012, 56014, Oct. 28, 1997; 65 FR 38178, eration); washing areas for equipment; June 20, 2000; 67 FR 6370, Feb. 12, 2002] shower areas; ventilation arrangements; and entries and exits; and, for a § 93.103 Import permits for birds; and reservation fees for space at quar- facility for hatching eggs of ratites in antine facilities maintained by which the hatching eggs of one lot may APHIS. be quarantined at the same time as the (a) Application for permit; reservation hatched chicks from a previously quar- required. Before any permit application antined lot, the incubation/hatcher and is submitted, all construction at the bird (chick) holding areas; and quarantine facility must be completed. (xii) Date and certification, by signa- (1) For pet birds, commercial birds, ture of the importer (permit appli- research birds, zoological birds, and cant), after the following language: performing or theatrical birds, in- I certify that the information provided tended for importation into the United herein is true and correct to the best of States, except as otherwise provided in my knowledge and belief, and agree to §§ 93.101(b) and (c), 93.103(c), and comply with the applicable regulations 93.107(b), the importer shall first apply for and obtain an import permit. The 8 VS import permit application forms are importer (permit applicant) shall sub- available from local offices of Veterinary mit a completed VS form 17–128 for Services, which are listed in telephone direc- ratites or hatching eggs of ratites; or, tories, or from the Animal and Plant Health for other birds, a completed VS form Inspection Service, Veterinary Services, Na- 17–20; or shall submit a document that tional Center for Import-Export, 4700 River Road Unit 38, Riverdale, Maryland 20737–1231. states that it is an application for a For other permit requirements for birds, the permit to import ratites, hatching eggs regulations issued by the U.S. Department of of ratites, or birds other than ratites or the Interior (title 50, Code of Federal Regula- hatching eggs of ratites. The applications, parts 14 and 17) should be consulted.

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in title 9, Code of Federal Regulations, (A) Any requirement of this subpart §§ 93.100 through 93.107; is not complied with; (xiii) In addition, the application for (B) The importer (permit applicant) a permit to import ratites or hatching or any person responsibly connected eggs of ratites, except for ratites and with the importer’s business, any per- hatching eggs of ratites imported from son responsibly connected with the pri- Canada in accordance with § 93.107, vately owned bird quarantine facility shall specify the number of ratites or through which the importation is in- hatching eggs intended for importa- tended, or, in the case of the importation, the size of the flock of origin, and tion of ratites or ratite hatching eggs, the location of the premises where the the operator of the flock of origin or a flock of origin is kept; and shall state person responsibly connected with the that, from the date of application owner of the flock of origin, has been through the date of export, APHIS rep- convicted of any crime under any law resentatives shall be granted access to regarding the import or export of the premises where the flock of origin goods, regarding the quarantine of any is kept. (For ratites intended for im- animal or bird, or the illegal move- portation as zoological birds, the flock ment of goods within a region, or in- of origin shall be the ratites intended volving fraud, bribery, extortion, or of for importation.) any other crime involving lack of the (2)(i) An import permit will be issued integrity needed for the conduct of op- only after an APHIS representative has erations affecting the importation of inspected the quarantine facility iden- birds; tified on the permit application, and (C) The importer (permit applicant) has determined that it meets the or any person responsibly connected standards set forth in § 93.106(c) of this with the importer’s business, any per- part. son responsibly connected with the pri- (ii) An application for a permit to vately owned bird quarantine facility import pet birds, commercial birds, re- intended for use for the importation, search birds, zoological birds, and per- or, in the case of the importation of forming or theatrical birds, may be de- ratites or ratite hatching eggs, the op- nied or withdrawn because of: Commu- erator of the flock of origin or a person nicable disease conditions in the area responsibly connected with the owner or region of origin, or in a region where of the flock of origin, threatens to forc- the shipment has been or will be held ibly assault or forcibly assaults, in- or through which the shipment has timidates, or interferes with any been or will be transported; defi- APHIS representative or employee in ciencies in the regulatory programs for or on account of the performance of his the control or eradication of animal or her official duties, unless, promptly diseases and the unavailability of vet- upon the incident being brought to the erinary services in the above men- importer’s attention by the authorized tioned countries; the importer’s failure supervisor of the APHIS representative to provide satisfactory evidence con- or employee, and to the satisfaction of cerning the origin, history, and health that supervisor, the importer justifies status of the animals; the lack of satis- the incident, takes effective steps to factory information necessary to deter- prevent a recurrence, or provides ac- mine that the importation will not be ceptable assurance that there will not likely to transmit any communicable be any recurrences; or disease to livestock or poultry of the (D) For any violation of the regula- United States; the lack of APHIS per- tions in this subpart. sonnel; any outstanding debts to (iii) In addition, a permit to import APHIS the permit applicant has not ratites or hatching eggs of ratites, ex- paid when due; or any other cir- cept for ratites or hatching eggs of cumstances which the Administrator ratites imported from Canada in ac- believes require such denial or with- cordance with § 93.107, will be denied or drawal to prevent the dissemination of withdrawn unless APHIS representa- any communicable disease of livestock tives are granted access to the prem- or poultry into the United States, such ises where the flock of origin is kept as if: (or, in the case of zoological birds, to

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the premises where the birds are kept), tice which shall be adopted for the pro- from the date of the application for the ceeding. However, withdrawal of a per- permit through the date of export. mit shall become effective pending (iv) Except for ratites intended for final determination in the proceeding, importation as zoological birds and when the Administrator determines ratites and hatching eggs of ratites im- that such action is necessary to pro- ported from Canada in accordance with tect the public health, interest, or safe- § 93.107, a permit to import ratites or ty. Such withdrawal shall be effective hatching eggs of ratites will be denied upon oral or written notification, or withdrawn unless an APHIS rep- whichever is earlier, to the importer. resentative has visited the premises In the event of oral notification, writ- where the flock of origin is kept within ten confirmation shall be given to the the 12-month period before the in- importer as promptly as circumstances tended importation and has determined permit. This withdrawal shall continue that the flock is pen-raised and con- in effect pending the completion of the tains sufficient breeding pairs to proceeding and any judicial review produce the number of ratites or hatch- thereof, unless otherwise ordered by ing eggs intended for importation. the Administrator. (v) A permit to import ratites or (viii) If APHIS receives more than hatching eggs of ratites will be denied one application for a permit to import or withdrawn if an inspection of the birds through a specified port of entry premises of the flock or origin, carried at approximately the same time, such out by the national government of the that APHIS personnel could provide region of export under § 93.101(b)(3), in- services to only one importer (permit dicates that the ratites and hatching applicant) who requests them, APHIS eggs are not identified and marked as will issue the permit to the first im- required under § 93.101(b)(3). porter who meets the requirements of (vi) For the purposes of this section, this subpart to deposit, with the Ad- a person shall be deemed to be respon- ministrator, the completed cooperative sibly connected with an importer’s and trust fund agreement, accompanied business, a privately owned bird quar- by the required deposit. antine facility, or an owner of a flock of origin, if such person has an owner- (3)(i) The importer or importer’s ship, mortgage, or lease interest in the agent shall pay or ensure payment of a physical plant of the importer’s busi- reservation fee for each lot of birds to ness, the privately owned bird quar- be quarantined in a facility maintained antine facility, or the farm of the flock by USDA. For birds the reservation fee of origin, or if such person is a partner, shall be 100 percent of the cost of pro- officer, director, holder or owner of 10 viding care, feed, and handling during per centum or more of the voting stock quarantine, as estimated by the quar- of the importer’s business, the pri- antine facility’s veterinarian in charge. vately owned bird quarantine facility, (ii) At the time the importer or the or the farm of the flock of origin, or is importer’s agent requests a reservation an employee of the importer’s business, of quarantine space, the importer or the privately owned bird quarantine fa- importer’s agent shall pay the reserva- cility, or the owner of the flock of ori- tion fee by check or U.S. money order gin. or ensure payment of the reservation (vii) A permit may be denied or with- fee by an irrevocable letter of credit drawn at any time by the Adminis- from a commercial bank (the effective trator, for any of the reasons provided date on such letter of credit shall run in paragraphs (a)(2)(ii), (iii), (iv), or (v) to 30 days after the date the birds are of this section. Before such action is scheduled to be released from quar- taken, the importer will be informed of antine); except that anyone who issues the reasons for the proposed action a check to the Department for a res- and, upon request in case of a dispute ervation fee which is returned because of material facts, shall be afforded an of insufficient funds shall be denied opportunity for a hearing with respect any further request for reservation of a to the merits or validity of such ac- quarantine space until the outstanding tion, in accordance with rules of prac- amount is paid.

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(iii) Any reservation fee paid by the closing of an airport due to inclem- check or U.S. money order shall be ap- ent weather or the unavailability of plied against the expenses incurred for the reserved space due to the extension services received by the importer or of another quarantine.) importer’s agent in connection with (v) If the reservation fee was ensured the quarantine for which the reserva- by a letter of credit and the fee is to be tion was made. Any part of the reserva- forfeited under paragraph (a)(3)(iv) of tion fee which remains unused after this section, the Department will draw being applied against the expenses in- against the letter of credit unless the curred for services received by the im- reservation fee is otherwise paid at porter or the importer’s agent in con- least 3 days prior to the expiration nection with the quarantine for which date of the letter of credit. the reservation was made, shall be re- (vi) When a reservation is cancelled turned to the individual who paid the in accordance with paragraph reservation fee. If the reservation fee is (a)(3)(iv)(A) of this section and the pro- ensured by a letter of credit, the De- visions of paragraph (a)(3)(iv)(B) of this partment will draw against the letter section do not apply, a $40.00 cancella- of credit unless payment for services tion fee shall be charged. If a reserva- received by the importer or importer’s tion fee was paid, the cancellation fee agent in connection with the quar- shall be deducted from any reservation antine is otherwise made at least 3 fee returned to the importer or the im- days prior to the expiration date of the porter’s agent. If the reservation fee letter of credit. was ensured by a letter of credit, the (iv) Any reservation fee shall be for- Department will draw the amount of feited if the importer or the importer’s the cancellation fee against the letter agent fails to present for entry, within of credit unless the cancellation fee is 24 hours following the designated time otherwise paid at least 3 days prior to of arrival, the lot of birds for which the the expiration date of the letter of reservation was made: Except that a credit. reservation fee shall not be forfeited if: (4) Permit applications for ratites. (i) If (A) Written notice of cancellation quarantine space for ratites is desired from the importer or the importer’s at either the New York Animal Import agent is received by the office of the Center or the Miami Animal Import veterinarian in charge of the quar- Center, permit applications must be 9 antine facility during regular business submitted to the New York Animal Im- hours (8:00 a.m. to 4:30 p.m. Monday port Center, USDA, APHIS, Veterinary through Friday, excluding holidays) no Services, 200 Drury Lane, Rock Tavern, later than 15 days for birds prior to the NY, 12575, or to the port veterinarian in beginning of the time of importation as charge of the New York Animal Import specified in the import permit or as ar- Center. ranged with the veterinarian in charge (ii) Quarantine space for ratites will of the quarantine facility if no import be offered in the order that permit ap- permit is required (the 15 day period plications are or have been received, shall not include Saturdays, Sundays, beginning with those permit applica- or holidays), or tions received on August 12, 1991. Res- (B) The Administrator determines ervations for quarantine space at the that services, other than provided by Miami Animal Import Center will be carriers, necessary for the importation limited to a maximum of 100 ratites per of the poultry or birds within the re- permit application. There will be a sin- quested period are unavailable because gle waiting list for quarantine space at of unforeseen circumstances as deter- the Miami Animal Import Center and mined by the Administrator, (such as the New York Animal Import Center. Importers who prefer one of these two 9 The addresses of USDA quarantine facili- facilities over the other may remain on ties may be found in telephone directories the waiting list until space opens up at listing the facilities or by contacting the Animal and Plant Health Inspection Service, the facility of their choice. Veterinary Services, National Center for Im- (b) Permit. Except as provided in port-Export, 4700 River Road Unit 38, River- paragraph (c) of this section, when a dale, Maryland 20737–1231. permit is issued, the original and two

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copies will be sent to the importer. It (vii) The name and address of the per- shall be the responsibility of the im- son to whom the birds or poultry will porter to forward the original permit be delivered. and one copy to the shipper in the re- (2) The importer completes a copy of gion of origin, and it shall also be the the import permit obtained under para- responsibility of the importer to insure graph (c)(1) of this section for each sep- that the shipper presents the copy of arate shipment of birds intended to the permit to the carrier and makes transit the port of Anchorage, Alaska, proper arrangements for the original by inserting the following information permit to accompany the shipment to on a copy of the permit: the specified U.S. port of entry for (i) The species, breed, and number of presentation to the collector of cus- birds to be imported; toms. The time prescribed in permits (ii) The region of origin; from the importation of pet birds, com- (iii) The name and address of the ex- mercial birds, zoological birds, or re- porter; (iv) The port of embarkation in the search birds, shall not exceed 30 days, foreign region; and for performing or theatrical birds (v) The mode of transportation and shall not exceed 90 days. Birds for the route of travel; which a permit is required by these (vi) The proposed date of arrival of regulations will not be eligible for the birds; and entry if a permit has not been issued; if (vii) The name and address of the per- unaccompanied by such a permit; if son to whom the birds will be deliv- shipment is from any port other than ered. the one designated in the permit; if ar- (3) The importer, not less than 2 rival in the United States is at any weeks prior to the anticipated date of port other than the one designated in arrival of each separate intransit ship- the permit; if the birds offered for ment of birds at the port of Anchorage, entry differ from those described in the Alaska, provides the port veterinarian permit. with a copy of the completed import (c) Notwithstanding any other provi- permit; sions in this part, importers are not re- (4) A copy of the completed import quired to obtain an import permit and permit accompanies each separate provide the shipper with an original intransit shipment of birds or poultry import permit for each individual ship- to the port of Anchorage, Alaska; ment of birds other than ratites (5) Import permits issued for mul- transiting the port of Anchorage, Alas- tiple shipments of birds transiting the ka, if the following conditions are met: port of Anchorage, Alaska, will be (1) The importer applies for and ob- valid only during the calendar year in tains an import permit for multiple which they are issued. shipments of birds transiting the port (Approved by the Office of Management and of Anchorage, Alaska, in accordance Budget under control number 0579–0040) with the provisions of this section and [55 FR 31495, Aug. 2, 1990, as amended at 56 related requirements concerning appli- FR 31866, July 12, 1991; 57 FR 21725, May 22, cation for the permit. However, the fol- 1992; 59 FR 10733, Mar. 8, 1994; 59 FR 47068, lowing information is not required on Sept. 14, 1994; 59 FR 47235, Sept. 15, 1994; 59 the application: FR 67614, Dec. 30, 1994; 61 FR 68125, Dec. 27, (i) The species, breed, and number of 1996. Redesignated and amended at 56012, birds to be imported; 56014, Oct. 28, 1997; 65 FR 38178, June 20, 2000] (ii) The region of origin; § 93.104 Certificate for pet birds, com- (iii) The name and address of the ex- mercial birds, zoological birds, and porter; research birds. (iv) The port of embarkation in the (a) General. All pet birds, except as foreign region; provided for in § 93.101 (b) and (c) of this (v) The mode of transportation and part; all research birds; and all com- the route of travel; mercial birds and zoological birds, in- (vi) The proposed date of arrival of cluding ratites and hatching eggs of the birds; and ratites, offered for importation from

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any part of the world, shall be accom- the veterinarian issuing the certifi- panied by a certificate issued by a full- cate; time salaried veterinary officer of the (2) That, except when the certificate national government of the exporting is for zoological birds or ratites im- region, or issued by a veterinarian au- ported from Canada in accordance with thorized or accredited by the national § 93.107, the flock of origin is pen- government of the exporting region raised and the ratites covered by the and endorsed by a full-time salaried certificate were produced and main- veterinary officer of the national gov- tained in that flock; ernment of that region. (3) That no evidence of Newcastle dis- (b) Birds other than ratites. The cer- ease, chlamydiosis, or other commu- tificate for birds other than ratites nicable disease of poultry was found in must state: the flock of origin; (1) That all birds covered by the cer- (4) That insofar as has been possible tificate have been inspected by the vet- to determine, the flock of origin was erinarian issuing the certificate; not exposed to Newcastle disease, (2) That no evidence of Newcastle dis- chlamydiosis, or other communicable ease, chlamydiosis, or other commu- disease of pountry during the 90 days nicable disease of poultry was found immediately preceding the expor- among the birds; tation; (3) That insofar as has been possible (5) That none of the ratites intended to determine, the birds were not ex- for shipment to the United States have posed to Newcastle disease, chlamydiosis, or other communicable been vaccinated with Newcastle disease disease of poultry during the 90 days vaccine or with a vaccine for the H5 or immediately preceding their expor- H7 subtype of avian influenza; tation; (6) That Newcastle disease did not (4) That the birds have not been vac- occur anywhere on the premises where cinated with with a vaccine for the H5 the flock of origin was kept or on adja- or H7 subtype of avian influenza; cent premises during the 90 days imme- (5) That Newcastle disease did not diately preceding the exportation; occur anywhere on the premises from (7) That neither the premises where which the birds were to be exported or the flock of origin was kept nor any ad- on adjacent premises during the 90 jacent premises was located in any days immediately preceding the expor- area under quarantine for poultry dis- tation of the birds; eases at any time during the 90 days (6) That neither the premises from immediately preceding the expor- which the birds were to be exported nor tation, and that the ratites have not any adjacent premises were located in been moved through a region identified any area under quarantine for poultry in accordance with § 94.6(a) of this sub- diseases at any time during the 90 days chapter as a region where highly path- immediately preceding the exportation ogenic avian influenza exists; of the birds, and that the birds have (8) That, except as provided in § 93.107 not been moved through a region iden- for ratites imported from Canada for tified in accordance with § 94.6(a) of immediate slaughter, the ratites were this subchapter as a region where high- treated at least 3 days but not more ly pathogenic avian influenza exists; than 14 days before being loaded for and shipment to the United States with a (7) That the birds were placed into pesticide of a type and concentration previously unused containers at the sufficient to kill ectoparasites on the premises from which the birds were to ratites; be exported. (9) That the pesticide was applied to (c) Ratites other than hatching eggs. all body surfaces of the ratites under The certificate for ratites other than the supervision of the veterinarian hatching eggs must state: issuing the certificate; (1) That, except as provided in para- (10) That the ratites, after being graph (c)(13) of this section, all ratites treated for ectoparasites, did not have covered by the certificate, and their physical contact with, or share a pen flock of origin, have been inspected by or bedding materials with, any ratite

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not in the same shipment to the United immediately preceding the exportation States; and of the hatching eggs; (11) That the ratites were placed in (5) That Newcastle disease did not previously unused containers for ship- occur anywhere on the premises where ment to the United States at the prem- the flock of origin was kept or on adja- ises where the flock of origin was kept. cent premises during the 90 days imme- (12) The number of ratites contained diately preceding the exportation of in the shipment; the hatching eggs; (13) That the number of ratites and (6) That neither the premises where hatching eggs of ratites exported from the flock of origin was kept nor any ad- the flock of origin has not exceeded the jacent premises were located in any ceiling required to be established under area under quarantine for poultry dis- § 93.101(b)(3)(ix); eases at any time during the 90 days (14) That all the ratites and hatching immediately preceding the exportation eggs of ratites in the flock from which of the hatching eggs; and the ratites come were identified in ac- (7) That the hatching eggs were cordance with § 93.101(b)(3); placed into previously unused containers for shipment to the United (15) Except for ratites imported from States at the premises where the flock Canada in accordance with § 93.107, the of origin was kept. number of ratite laying hens in the (8) The number of hatching eggs con- flock from which the ratites come; tained in the shipment; (16) For ratites required to be treated (9) That the number of ratites and prior to shipment with a pesticide for hatching eggs of ratites exported from ectoparasites, the certificate must also the flock of origin has not exceeded the state the name, concentration, and ceiling required to be established under date of administration of the pesticide § 93.101(b)(3)(ix); used to treat the ratites; (10) That all the ratites and hatching (17) When ratites intended for impor- eggs of ratites in the flock from which tation are zoological birds, only the the hatching eggs come were identified ratites to be imported must be in- in accordance with § 93.101(b)(3); spected, and the provisions in para- (11) Except for hatching eggs of graphs (c)(3), (c)(4), (c)(5), (c)(6), (c)(7), ratites imported from Canada in ac- and (c)(11) that apply to the flock of or- cordance with § 93.107, the number of igin shall apply only to the ratites in- ratite laying hens in the flock from tended for importation. which the hatching eggs come. (d) Hatching eggs of ratites. The certificate for hatching eggs of ratites (Approved by the Office of Management and must state: Budget under control number 0579–0040) (1) That the flock of origin of the [56 FR 31866, July 12, 1991; 56 FR 41726, Aug. hatching eggs has been inspected by 22, 1991, as amended at 57 FR 28080, June 24, the veterinarian issuing the certifi- 1992; 59 FR 10733, Mar. 8, 1994; 59 FR 47235, cate; Sept. 15, 1994; 61 FR 56891, Nov. 5, 1996; 61 FR 68126, Dec. 27, 1996. Redesignated and amend- (2) That, except when the certificate ed at 62 FR 56012, 56014, Oct. 28, 1997; 76 FR is for hatching eggs of ratites imported 4053, Jan. 24, 2011] from Canada in accordance with § 93.107, the flock of origin is pen- § 93.105 Inspection at the port of raised, and the hatching eggs covered entry. by the certificate were produced by (a) All commercial birds, zoological that flock; birds, and research birds, including (3) That no evidence of Newcastle dis- hatching eggs of ratites, but excluding ease, chlamydiosis, or other commu- other ratites, imported into the United nicable disease of poultry was found in States, must be inspected by the port the flock of origin; veterinarian at the Customs port of (4) That insofar as has been possible entry, which may be any international to determine, the flock of origin was airport, or any land-border port within not exposed to Newcastle disease, 20 miles of an international airport, chlamydiosis, or other communicable serviced by Customs, as well as, for Ca- disease of poultry during the 90 days nadian-origin hatching eggs of ratites,

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ports listed in § 93.107 (c). However, out’’ basis, at a Customs port of entry, hatching eggs of ratites may be at a USDA quarantine facility when ar- shipped, in bond, from the port of first rangements have been made in advance arrival to the Customs port of entry at by the importer and approval is grant- which they will be quarantined, for ined in the permit described in § 93.103, or spection, at that port. in facilities that meet the require- (b) All pet birds imported from any ments of paragraph (c) of this section. part of the world, except pet birds from At a USDA quarantine facility each Canada and pet birds meeting the pro- psittacine bird shall be individually visions of § 93.101(c)(2), shall be sub- identified by the Department within 7 jected to inspection at the Customs days of the entry of the bird into the port of entry by a veterinary inspector bird quarantine facility with a serially of APHIS and such birds shall be per- numbered legband which has been mitted entry only at the ports listed in coded to the quarantine facility or by § 93.102(a). Pet birds of Canadian origin other suitable means of identification. and those birds meeting the provisions The identification device must be ap- of § 93.101(c)(2) shall be subject to vet- proved by the Administrator, before it erinary inspection at any of the ports shall be used to identify birds under of entry listed in § 93.102 and 93.203. this section. Such means of identifica- (c) Ratites, other than hatching eggs tion shall be supplied by the Depart- of ratites, imported from any part of ment at cost to the importer. The De- the world must be inspected at the Cus- partment shall make an identification toms port of entry by a veterinary in- record at the time such bird is so iden- spector of APHIS and, except as pro- tified containing the species of the vided in § 93.107(b) for ratites imported bird, including the common and sci- from Canada, shall be permitted entry entific name, and the number of the only at one of the following ports of entry: identification device placed on the (1) Ostriches: bird. The daily log and the identifica- (i) Up to 36 inches in height (as meas- tion record shall be maintained for 12 ured from the top of the head to the months following the date of the re- base of the feet) or 30 pounds in weight: lease of the bird from quarantine. Prior New York, NY; Stewart Airport, New- to use of a privately owned quarantine burgh, NY; and Miami, FL. facility, a Cooperative and Trust Fund (ii) Exceeding 36 inches in height or Agreement as set forth in paragraph 30 pounds in weight: New York, NY, (c)(5) of this section shall be executed and Stewart Airport, Newburgh, NY. by the importer and the Department (2) Ratites other than ostriches: New and appropriate funds shall be depos- York, NY; Stewart Airport, Newburgh, ited with the Administrator pursuant NY; and Miami, FL. to the Cooperative and Trust Fund Agreement. If the birds are found free [55 FR 31495, Aug. 2, 1990, as amended at 56 of evidence of communicable diseases FR 31867, July 12, 1991; 57 FR 21726, May 22, of poultry during quarantine, then the 1992; 59 FR 36026, July 15, 1994; 59 FR 47069, Sept. 14, 1994; 61 FR 68126, Dec. 27, 1996. Re- port veterinarian shall issue an agri- designated and amended at 62 FR 56012, 56014, culture release for entry through U.S. Oct. 28, 1997; 65 FR 38178, June 20, 2000] Customs. If the birds are found during port of entry inspection or during quar- § 93.106 Quarantine requirements. antine, to be infected with or exposed (a) Birds other than ratites and hatch- to a communicable disease of poultry, ing eggs of ratites. Each lot of pet birds, such birds shall be refused entry or except as provided for in § 93.101(c) of shall be held for an additional period in this part; research birds; and commer- quarantine until determined to be free cial birds and zoological birds, except of evidence of any communicable dis- ratites and hatching eggs of ratites, ease, or shall be otherwise disposed of imported into the United States shall as directed by the Administrator. See be quarantined for a minimum of 30 also paragraph (c)(3)(ii)(E) of this sec- days, and for such longer period as may tion. be required by the Administrator, in (b) Ratites and hatching eggs of ratites. any specific case, on an ‘‘all-in, all- (1) Each lot of ratites imported from

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any part of the world except as pro- the inspector determines that the vided in § 93.107, shall be quarantined ratites are free of ectoparasites. upon arrival for a minimum of 30 days, (4) If the ratites, including chicks and for such longer period as may be hatched during quarantine, are deter- required by the Administrator to determined to be free of communicable dis- mine the ratites’ freedom from eases, the port veterinarian shall issue ectoparasites and communicable dis- an agricultural release for entry eases. Quarantine shall be on an ‘‘all- through U.S. Customs. If the port vet- in, all-out’’ basis, as described in para- erinarian finds evidence of commu- graph (c)(3)(ii)(A) of this section, at the nicable disease, or exposure to commu- New York Animal Import Center at nicable disease, during port of entry in- Newburgh, NY, when the port of entry spection or quarantine of the ratites, is either New York, NY, or Stewart the ratites shall be refused entry, or Airport, Newburgh, NY; or at the shall be held in quarantine until they Miami Animal Import Center, Miami, are determined to be free of communicable disease, or shall be otherwise FL, when the port of entry is Miami, disposed of as directed by the Adminis- FL. Reservations for space in these trator. quarantine facilities must be made in (c) Standards for privately owned bird advance of arrival and in accordance quarantine facilities and handling proce- with § 93.103 of this part. dures for importation of birds. Before the (2) Each lot of hatching eggs of Administrator will issue an import per- ratites imported from any part of the mit for a lot of birds, the Adminis- world except as provided in § 93.107, trator must determine that the pri- shall be quarantined upon arrival, in- vately owned bird quarantine facility cubated for the full incubation period to be used to quarantine birds imported (approximately 42 days), and held in into the United States (the facility) quarantine for a minimum of 30 days and its maintenance and operation following the hatch of the last chick in meet the minimum requirements of the lot, and for such longer period as paragraphs (c)(1) through (c)(5) of this may be required by the Administrator section, that adequate APHIS per- to determine the ratites’ freedom from sonnel are available to provide services communicable diseases. Quarantine required by the facility, and that a Co- shall be conducted at a facility that operative and Trust Fund Agreement meets the requirements of paragraph between the importer and the Depart- (c) of this section, and in the manner ment has been executed, and the re- prescribed by paragraph (c) of this sec- quired funds have been deposited, in action. cordance with that agreement. The (3) During the quarantine period, the cost of the facility and all costs associ- ratites, including chicks hatched in ated with its maintenance and oper- quarantine, shall be tested for viral ation must be borne by the importer, diseases of poultry, including New- in accordance with the provisions of castle disease. If any of the ratites ex- paragraph (e) of this section. hibit evidence of other communicable (1) Supervision of the facility. The fa- diseases, they will be subjected to such cility shall be maintained under the su- additional tests as may be required by pervision of the port veterinarian at the Administrator to determine their the Customs port of entry. freedom from communicable diseases. (2) Physical plant requirements. The fa- Ratites other than those imported as cility shall comply with the following hatching eggs also shall be treated for requirements: ectoparasites 10 by an inspector until (i) Location. Each privately owned bird quarantine facility shall be located: 10 APHIS will use an EPA registered dust (A) Within the immediate metropoli- formulation that contains 5 percent carbaryl tan area of the port of entry to prevent as the only active ingredient. The dust formulation will be used in accordance with all the imported birds, while in transit to applicable directions, restrictions, and pre- the quarantine facility, from intro- cautions on the label. Treated birds may not ducing or disseminating disease to do- be slaughtered for food purposes. mestic poultry or livestock.

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(B) At least one-half mile from any (G) Have a separate area for washing concentration of avian species, such as, facility equipment; but not limited to, poultry processing (H) Have a shower at the entrance plants, poultry or bird farms, pigeon into the area comprised of the bird lofts, or other bird quarantine facili- holding and necropsy rooms and a ties. Factors such as prevailing winds, clothes storage and change area at the efficiency of the air filtration sys- each end of the shower area; tem of the quarantine facility, possible (I) Have a storage area for equipment exposure to poultry or birds moving in necessary for quarantine operations; local traffic, etc., shall be taken into (J) Have equipment necessary to consideration. maintain the facility in clean and sani- (ii) Construction. Each quarantine fa- tary condition, including insect and cility shall consist of a single, self-con- pest control equipment; tained building, which shall: (K) Have a receptacle for soiled and (A) Be constructed only with mate- contaminated clothing in the clothes rial that can withstand continued change area located nearest the en- cleaning and disinfection. All solid trance to the bird holding area; walls, floors, and ceilings must be con- (L) All construction must be com- structed of impervious material. All pleted before any permit application is openings to the outside must be dou- submitted in accordance with § 93.103. ble-screened, with an interior screen of (M) An APHIS representative shall metal or nylon mesh that is impervious inspect the facility to determine to biting insects such as gnats or mos- whether the facility complies with the quitos, and an exterior metal screen standards set forth in this section be- that is rodent-proof and is made of fore any permit is issued in accordance wire, such as rabbit wire, hardware with § 93.103. Inspections shall take cloth, or smooth welded wire, with place at least once each year. (N) In addition, a facility for hatch- mesh size no larger than 1 inch×1.5 ing eggs of ratites, in which the hatch- inches (2.54 cm×3.81 cm). The interior ing eggs of one lot may be quarantined and exterior screens must be separated at the same time as the hatched chicks by at least 3 inches (7.62 cm); from the previously quarantined lot, (B) Have a bird holding area of suffi- shall: cient size to prevent overcrowding of (1) Have a wall or a wall with a lock- the birds in quarantine. (All access able door separating the incubator/ into this holding area shall be from hatcher area from the bird (chick) within the building and each entryway holding area, and this wall or wall- into such area shall be equipped with with-door shall provide an airtight seal self-closing, double doors: Provided, between the two areas, shall be imper- That emergency exits to the outside vious to water, and shall be able to may exist in the bird holding area if re- withstand continued cleaning and dis- quired by local fire ordinances. Such infection; emergency exits shall be constructed (2) Have a necropsy or sample collec- so as to permit their opening from the tion area in both the incubator/hatcher inside of the facility only.); area and the bird (chick) holding area; (C) Have a ventilation capacity suffi- and cient to control moisture and odor at (3) Have separate entrances, showers, levels that are not injurious to the toilets, and dressing room facilities for health of the birds in quarantine; the exclusive use of personnel working (D) Have a vermin-proof feed storage in the incubator/hatcher area and the area; bird (chick) holding area. (E) Have office space for record- (O) The bird (chick) holding area in keeping; any facility for hatching eggs of ratites (F) Have a separate necropsy room shall be of a size large enough to ac- which shall have refrigerated storage commodate 75 percent of the incubator space for carcasses retained for labora- capacity, with a minimum of 10 square tory examination and facilities ade- feet per egg. quate for specimen preparation and (P) If a facility for hatching eggs of carcass disposal; ratites has a sun room, the sun room

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shall be connected to the chick holding to record the entry and exit of all per- area by a wall with a lockable door. sons entering the facility and controls This wall; the other walls, if any; and at all doorways and other openings to the flooring, must be impervious to the facility to prevent escape or acci- water and able to withstand continued dental entry of birds. cleaning and disinfection. All walls of (3) Operational procedures. The fol- the sun room must be at least 8 feet lowing procedures shall be observed at high. the facility at all times. (1) Any of the exterior walls may be (i) Personnel. Access to the facility replaced by a double-screened wall set shall be granted only to persons work- in a concrete or concrete-block curb. ing at the facility or to persons specifi- The double screening shall be of wire cally granted such access by the port mesh or wire mesh and nylon mesh, as veterinarian. provided in paragraph (c)(2)(ii)(A) of (A) All personnel granted access to this section, with the interior and exte- the bird holding area or the incubator/ rior screens of the sun room wall sepa- hatcher area shall: rated by at least 3 inches (7.62 cm); the (1) Wear clean protective clothing concrete or concrete block curb must and footwear upon entering the bird be at least 12 inches high, impermeable holding area or the incubator/hatcher to water, and able to prevent the es- area; cape of water, manure, and debris. ( ) Change protective clothing and (2) The sun room shall have a roof, 2 such as a double-mesh-screened roof or footwear when they become soiled or a glass roof, that is both impervious to contaminated; free-flying birds and biting insects (3) Shower when entering and leaving (such as gnats or mosquitoes) and capa- any bird holding area, any incubator/ ble of preventing contact between hatcher area, and any necropsy area. chicks and free-flying birds. Showering when moving between the (3) Be attended by personnel working incubator/hatcher area and the bird in the bird (chick) holding area when- holding area is not required when the ever chicks are in the sun room. eggs in the hatching area and the (iii) Sanitation and security. Arrange- chicks in the holding area are part of ments shall exist for: the same lot; (A) A supply of water adequate to (4) Work exclusively with one lot of meet all watering and cleaning needs. birds until the lot’s release from quar- (B) Disposal of wastes by inciner- antine, and have no contact with other ation or a public sewer system which birds or poultry until the release date. meets all applicable environmental (B) The importer shall handle soiled quality control standards; clothing worn within the quarantine (C) Control of surface drainage onto unit in a manner approved by the port or from the facility to prevent any dis- veterinarian as adequate to preclude ease agent from entering or escaping; transmission of a poultry disease agent (D) Protective clothing and footwear from the facility. adequate to insure that workers at the (ii) Handling of the birds in quarantine. facility have clean clothing and foot- The birds shall be kept in the quar- wear at the start of each workday and antine facility for a minimum of 30 at any time such articles become soiled days and while in quarantine shall be or contaminated; handled in compliance with the fol- (E) Power cleaning and disinfecting lowing requirements: equipment with adequate capacity to (A) Each lot of birds to be quar- disinfect the facility and equipment; antined shall be placed in the facility (F) Sufficient stocks of a disinfectant on an ‘‘all-in, all-out’’ basis. No birds authorized in § 71.10(a)(5) of this chap- shall be taken out of the lot while it is ter; in quarantine except for diagnostic (G) A security system which prevents purposes and if additional birds are contact of birds in quarantine with per- added to a lot, the total quarantine pe- sons not authorized entry to the facil- riod for that lot shall be extended so ity and with other birds and animals. that all birds will have completed at Such a system shall include a daily log least 30 consecutive days of quarantine

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before release for entry into the com- port of entry for necropsy by a Depart- merce of the United States. The quar- ment poultry disease diagnostician antine period may be extended as pro- who may submit specimens from such vided in paragraph (a) of this section. birds for laboratory examination. (1) Hatching eggs of ratites com- (E) During the period of quarantine, prising a single lot may be added to the the birds shall be subjected to such facility in stages, provided the entire tests and procedures as are required in lot has been placed in the facility no specific cases by the port veterinarian, later than 15 days after the arrival of to determine whether the birds are free the first shipment. from communicable diseases of poultry (2) If hatching eggs of ratites begin to and it shall be the responsibility of the hatch in the incubator/hatcher area importer to identify individually each while ratite chicks from the previously psittacine bird within 7 days of the quarantined lot remain in the bird entry of the bird into the quarantine (chick) holding area, then the separate facility with a serially numbered lots assume the status of a single lot, legband which has been coded to the and will be released from quarantine in quarantine facility or by other suitable accordance with paragraph (c)(3)(ii)(A) means of identification. Any identifica- of this section. tion device must be approved by the (B) The birds may be vaccinated dur- Administrator, upon written request to ing quarantine only with a vaccine him, before it shall be used to identify that has been approved by the Admin- birds under this section. Such means of istrator, and is administered by a li- identification shall be supplied by the censed veterinarian under the direct importer, and the importer shall insure supervision of a veterinarian employed that each bird is so identified at the by the Animal and Plant Health In- time the bird is released from the facil- spection Service. The Administrator ity. If frank or clinical Newcastle dis- will approve a vaccine if: ease occurs among any birds in quar- (1) The vaccine is licensed by the antine, all birds in the facility shall be Animal and Plant Health Inspection destroyed or refused entry and the en- Service in accordance with § 102.5 of tire facility shall be thoroughly this chapter; and cleaned and then disinfected as di- (2) The vaccine is not one that is used rected under the supervision of an in- to prevent Newcastle disease, avian inspector. fluenza, or any other hemagglutinating 11 (F) The quarantine facility from virus of poultry. which a lot of birds has been released (C) Birds of the psittacine family shall be thoroughly cleaned and dis- shall receive a balanced, medicated infected with a disinfectant authorized feed ration treatment containing not in § 71.10(a)(5) of this chapter, under su- less than 1% CTC with not more than pervision of an inspector before a new 0.7% calcium for the entire quarantine lot is placed in the facility. period as a precautionary measure (iii) Records. It shall be the responsi- against chlamydiosis (psittacosis). bility of the importer to maintain a (D) The importer shall immediately collect all birds which die in quar- current daily log for each lot of birds, antine and hold them under refrigera- recording such information as the gen- tion, within the facility, shall account eral condition of the birds each day, for all birds in the shipment, and shall source of origin of the birds in the lot, not dispose of any carcass or parts total number of birds in the lot when thereof unless authorized to do so by a imported, number of dead birds when Veterinary Medical Officer of APHIS of lot arrived, date lot was placed into the the Department. Birds that die enroute facility, number of deaths each day in to the United States or while in quar- the lot during the quarantine period, antine shall be made available at the necropsy results, and laboratory findings on birds that died during the quarantine date of prescribed tests and re- 11 A list of approved vaccines is available from the Animal and Plant Health Inspec- sults, Department import permit num- tion Service, Veterinary Services, National bers of each lot, date lot was removed Center for Import-Export, 4700 River Road from the facility, and any other obser- Unit 38, Riverdale, Maryland 20737–1231. vations pertinent to the general health

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of the birds in the lot. The importer determined by the Administrator to be shall also make an identification sufficient to cover all costs incurred by record, at the time each psittacine bird the Department in providing services is identified, containing the species of in accordance with that agreement, as the bird, including the common and specified in paragraph (c)(5)(iii) of this scientific name and the number of the section. identification device placed on each (iii) Cooperative and Trust Fund psittacine bird. The daily log and the Agreement. identification record shall be main- COOPERATIVE AND TRUST FUND AGREEMENT tained for 12 months following the date BETWEEN lll (NAME OF IMPORTER) AND of release of the bird from quarantine THE UNITED STATES DEPARTMENT OF AGRI- and shall be made available to APHIS CULTURE, ANIMAL AND PLANT HEALTH IN- personnel upon request. SPECTION SERVICE. (4) Additional requirements as to lo- This agreement is made and entered into cation, security, physical plant and fa- by and between lllll (name of im- cilities, sanitation, and other items porter), hereinafter referred to as the Im- may be imposed by the Administrator, porter, and the U.S. Department of Agri- in each specific case in order to assure culture, Animal and Plant Health Inspection that the quarantine of the birds in such Service, hereinafter referred to as the Serv- facility will be adequate to enable de- ice, with respect to llllll (quarantine facility and address of facility). Whereas, the termination of their health status, pre- Service is authorized pursuant to the Animal vent spread of disease among birds in Health Protection Act (7 U.S.C. 8301 et seq.) quarantine, and prevent escape of poul- to regulate the introduction of animals into try disease agents from the facility. the United States in order to prevent the in- (5) Cooperative and Trust Fund troduction of animal and poultry diseases Agreement for services required by im- into the United States; and porter at a privately owned bird quar- Whereas, the Importer is interested in the importation of certain birds from regions antine facility. presently under restrictions for such impor- (i) When the Administrator deter- tation; and mines that a privately owned bird Whereas, the Importer is equipped with a quarantine facility meets the require- bird quarantine facility that meets the re- ments set forth in paragraph (c) of this quirements of paragraph (c) of this section; section, the Department and the im- and porter shall execute a Cooperative and Whereas, the Importer has requested the Service to conduct inspections, perform lab- Trust Fund Agreement, as specified in oratory procedures, complete examinations, paragraph (c)(5)(iii) of this section. In and supervise the isolation, quarantine, and conjunction with the Cooperative and care and handling of birds to insure that Trust Fund Agreement, the importer they meet the Department’s quarantine re- shall deposit with the Administrator a quirements before release into the United money order or cashier’s check in an States; and amount determined by the Adminis- Whereas, it is the intention of the parties hereto that such cooperation shall be for trator to cover all costs incurred by their mutual benefit and the benefit of the the Department in providing services people of the United States; in accordance with the provisions of Now therefore, for and in consideration of the Cooperative and Trust Fund Agree- the promises and mutual covenants herein ment. Any unobligated funds will, upon contained, the parties hereto do hereby mu- request, be returned to the importer, tually agree with each other as follows: after the birds’ release from quar- (A) The Importer Agrees: (1) To operate the quarantine facility in antine. accordance with all Federal Laws and regu- (ii) The Administrator may provide lations. services required by the importer at a (2) To provide a current list of designated privately owned quarantine facility for personnel employed by the Importer who will the importation of birds on a first be used to handle and care for birds during come, first served basis, if adequate the quarantine period. The list will include APHIS personnel are available to pro- the legal names, current residential addresses, and social security numbers of the des- vide those services, upon determining ignated personnel. The list will be furnished that the importer has executed a Coop- to the port veterinarian at the time an appli- erative and Trust Fund Agreement, cation for an import permit to import birds and has deposited funds in an amount into the quarantine facility is submitted to

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the Service. The list will be updated for any (11) To install a hood with a viewing win- changes in or additions to the designated dow over the necropsy table. personnel in advance of such personnel work- (12) To bag waste material in leakproof ing in the quarantine facility. bags. Such material shall be handled in a (3) To furnish to the Service a signed state- manner that spoilage is kept to a minimum ment from each of the designated personnel and control of pests is maintained. Such ma- employed by the Importer which provides terial shall be disposed of by incineration or that such personnel agree that for a period of by public sewer or other method authorized 3 days from their most recent contact with by the Administrator to prevent the spread birds in the quarantine facility, such per- of disease. The disposition of such material sonnel will refrain from having contact with shall only be under the direction and super- other birds and poultry. This restriction vision of the Service. ceases to apply on the date the birds are re- (13) To feed chlortetracycline to psittacine leased from quarantine. birds, upon their arrival in the facility as (4) To not permit any designated personnel prescribed in § 93.106(c)(3)(ii)(C). which the Service determines to be unfit to (14) To install an electronic security sys- be employed at a quarantine facility upon tem which is coordinated through or with written notice from the Service. Such deter- the local police so that monitoring of the mination shall be based upon such employ- quarantine facility is maintained whenever ee’s committing or aiding and abetting in Service personnel are not at the facility or, the commission of any violation of title 9, in lieu of such electronic monitoring system Code of Federal Regulations, part 93. The Im- to arrange for continuous guarding of the fa- porter further agrees to suspend any des- cility with personnel from a bonded, security ignated employee from working at a quar- company. Provided, That, if exotic Newcastle antine facility when the Service has reason disease is diagnosed in any of the birds in the to believe that such employee has violated quarantine facility, continuous guarding of any provision of title 9, Code of Federal Reg- the facility with personnel from a bonded se- ulations, part 93, and the Administrator has curity company shall be maintained by the determined that the actions of such em- Importer. The electronic security system if ployee constitute a severe threat to intro- installed shall be of the ‘‘silent type’’ and duce or disseminate a communicable disease shall be triggered to ring at the monitoring of poultry into the United States. Such ac- site and not at the facility. The electronic tion shall be made upon receipt of notice system shall be approved by Underwriter’s from the Service requiring such action by Laboratories. the Importer. Written instructions shall be provided to the (5) To allow the unannounced entry into monitoring agency which shall require that the quarantine facility of Service personnel upon activation of the alarm, the police and or other persons authorized by the Service a representative of the Service designated by for the purpose of inspecting birds in quar- the Service shall be notified by the moni- antine, the operations at the quarantine fa- toring agency. Such instructions, as well as cility and to ascertain compliance with the any changes in such instructions, shall be Standards for quarantine facilities and han- filed in writing with the Administrator. The dling procedures for importation of birds Importer shall notify the Service whenever a contained in title 9, Code of Federal Regula- break in security occurs or is suspected of tions, § 93.106(c). occurring. (6) To provide permanent restrooms in (15) To not have non-Service personnel in both the clean and the quarantine areas of the quarantine area when birds are in the the quarantine facility. quarantine facility unless Service personnel (7) To provide a T.V. monitoring system or are present. a window or windows sufficient to provide a (16) To have seals of the Service placed on full view of the quarantine area excluding all entrances and exits of the facility when the clothes changing area. determined necessary by the Service and to (8) To install a communication system be- take all necessary steps to ensure that such tween the clean and quarantine areas of the seals are only broken in the presence of quarantine facility. Such communication Service personnel. system shall not interfere with the mainte- (17) To decide what the disposition of a lot nance of the biological security of the quar- of birds will be within 48 hours following offi- antine area. cial notification that such a lot is infected (9) To secure all windows and any openings with or exposed to exotic Newcastle disease. in the quarantine facility in a manner satis- Final disposition of the infected or exposed factory to the Department which will insure lot is to be accomplished within 4 working the biological security of the quarantine fa- days following official notification. Disposi- cility and prevent the unauthorized removal tion of the birds will be under the super- of birds. vision of the Service. (10) To install tamperproof hasps and to in- (18) To furnish a telephone number or num- stall hinges on doors from which the pins bers to the Service at which the Importer cannot be removed. can be reached on a daily basis or furnish the

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same for an agent or representative that can charge of any designated personnel employed act and make decisions on the Importer’s be- by the Importer, the Service will inform, in half. writing, the Importer and the designated (19) To deposit with the Service, upon exe- personnel of the basis for such action. If such cution of this agreement, a money order or person contests such action he or she shall cashier’s check, in an amount determined by be permitted to present his or her views to the Administrator to be sufficient to defray the Administrator, provided such request is all costs incurred by the Service in providing made within 30 days of the receipt of the services required. If such costs exceed the de- aforementioned written notice. If a final deposited amount, the importer will pay for additional costs incurred, based on official ac- termination is made by the Administrator counting records, within 14 days of receipt of that such personnel should be discharged, he the bill showing the balance due. or she shall notify such personnel and the (20) To provide for the maintenance and op- Importer of such determination. eration of the quarantine facility in accord- (C) It is mutually understood and agreed: ance with standards for quarantine facilities (1) That a maximum capacity will be es- and handling procedures for importation of tablished for each quarantine lot. This will birds contained in title 9, Code of Federal be based upon the capacity of the quarantine Regulations, § 93.106(c). facility to handle the birds. The number of (B) The Service agrees: birds on the permits will not exceed this ca- (1) To furnish the services of technical and/ pacity. or professional personnel needed to conduct (2) If the seals referred to in paragraph inspections, perform laboratory procedures, (c)(5)(iii)(A)(16) of this section are broken by complete examinations, and supervise the isolation, quarantine, and care and handling other than Service personnel, it will be con- of birds being imported to ensure that they sidered a breach in security and an imme- meet the Department’s quarantine require- diate accounting of all birds in the facility ments before release into the United States. shall be made by the Service. If any birds are (2) To issue permits 3 working days fol- determined to be missing from the facility, lowing receipt of the permit application, de- the quarantine period will be extended for an pending upon the availability of personnel to additional 30-day period. provide the services required for quarantine (3) During the performance of this coopera- and the results of an APHIS representative’s tive work, the Importer agrees to be bound inspection of the quarantine facility. by the equal opportunity and nondiscrimina- (3) To provide the Importer within 30 days tion provisions as set forth in exhibit B and following receipt of a written request from nonsegregation of facilities provisions as set the Importer, with an accounting of funds forth in exhibit C, 12 which are attached here- expended in providing services under para- to and made a part thereof. graph (B)(1) of this agreement. Any unobligated balance upon termination or expira- (4) No member of or delegate to Congress tion of this agreement shall be returned to or resident commissioner, shall be admitted the Importer. to any share or part of this agreement or to (4) To inform the Importer when a diag- any benefit to arise therefrom; but this pro- nosis of END has been made in any facility. vision shall not be construed to extend to (5) To promptly inform the Embassy or this agreement if made with a corporation of Consulate of the foreign region to which lots its general benefit. of birds, refused entry into the United States (5) This agreement shall become effective due to a diagnosis of END, are to be shipped. upon date of final signature and shall con- (6) To notify in writing the Importer of any tinue until the permitted lot of birds is redesignated employee which the Service be- leased from quarantine. This agreement may lieves should be suspended from work at the be amended by agreement of the parties in quarantine facility and the basis for such ac- writing. It may be terminated by either tion. Similar notice shall be afforded to the party upon 30 days written notice to the designated employee. Subsequent to such other party. suspension, the designated employee shall have the right to request an immediate re- Date lllllllllllllllllllll view of such action by the Administrator, in- llllllllllllllllllllllll cluding presenting his or her views to the Importer Administrator in an informal conference. If Date lllllllllllllllllllll the Administrator makes a final determina- llllllllllllllllllllllll tion that grounds existed to suspend such employee, he or she shall notify the Importer and the suspended employee of his or her de- 12 Import-Export Animals Staff, Veterinary cision and such employee shall be discharged Services, APHIS, USDA, will furnish each by the Importer. importer with copies of exhibits B and C (7) Prior to any final determination being prior to their signing the Cooperative and made by the Service concerning the dis- Trust Fund Agreement.

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Administrator, Animal and Plant Health In- (b) Ratites from Canada. Ratites that spection Service, United States Depart- were hatched and raised in Canada or ment of Agriculture ratites that were legally imported into (d) Charges for services. The charges to Canada and, upon arrival in Canada, be borne by the importer for services were quarantined for a minimum of 28 provided for quarantine facilities ap- days at a Canadian quarantine facility proved in accordance with paragraph and remained in Canada for an addi- (c) of this section shall be: tional 60 days following completion of (1) The appropriate GS hourly rate quarantine may be imported into the (including appropriate premium pay in United States: accordance with 5 U.S.C. 5541–5549) of (1) Without being quarantined upon the employee who actually performs arrival in the United States; and the service, including his or her travel (2) At any of the following ports of time and his or her travel expenses: entry: Anchorage, AK; Fairbanks, AK; Provided, however, Such time and travel Los Angeles, CA; San Diego, CA; Den- expense shall not exceed the time and ver, CO; Miami, FL; Tampa, FL; At- travel expense to and from his or her lanta, GA; Eastport, ID; Chicago, IL; official duty station; New Orleans, LA; Boston, MA; Balti- (2) All applicable user fees, as listed more, MD; Houlton, ME; Jackman, ME; in part 130 of this chapter; and Detroit, MI; Port Huron, MI; Sault Ste. (3) A surcharge for overhead based on Marie, MI; Minneapolis, MN; Raymond, the most current historical data avail- MT; Sweetgrass, MT; Buffalo, NY; able showing the percentage of APHIS Champlain, NY; New York, NY; Stew- funds expended for administrative sup- art Airport, Newburgh, NY; Dunseith, port. ND; Pembina, ND; Portal, ND; Port- (e) Requirements of other Federal land, OR; San Juan, PR; Houston, TX; laws and regulations, such as the De- Highgate Springs, VT; Seattle, WA; partment’s Animal Welfare Regula- and Sumas, WA; and tions in subchapter A of this chapter (3) If offered for entry at a Canadian shall also apply as applicable to the land border port listed in § 93.203(b), quarantine facilities. without an import permit; and [55 FR 31495, Aug. 2, 1990. Redesignated at 62 (4) If consigned directly to slaughter FR 56012, Oct. 28, 1997] from the port of entry, without being

EDITORIAL NOTE: For FEDERAL REGISTER ci- treated for ectoparasites within 3 to 14 tations affecting § 93.106, see the List of CFR days before shipment to the United Sections Affected, which appears in the States, as otherwise required by Finding Aids section of the printed volume § 93.104(c)(8); and and at www.fdsys.gov. (5) If in compliance with all of the applicable regulations of the U.S. Fish CANADA 13 and Wildlife Service contained in Title § 93.107 Special provisions. 50, subchapter B, of the Code of Federal Regulations. (a) In-bond shipments from Canada. (c) Ratite eggs from Canada. Hatching Birds from Canada transported in-bond eggs of ratites that were laid in Canada through the United States for imme- may be imported into the United diate export shall be inspected at the States: border port of entry and, when accompanied by an import permit obtained (1) Without being quarantined upon under § 93.103 of this part and all condi- arrival in the United States; and tions therein are observed, shall be al- (2) At any of the ports of entry listed lowed entry into the United States and in paragraph (b)(2) of this section or shall be otherwise handled as provided authorized by § 93.105(a); and in paragraph (d) of § 93.101. (3) If offered for entry at a Canadian land border port listed in § 93.203(b), without an import permit; and 13 Importations from Canada shall be subject to § 93.107, in addition to other sections (4) If in compliance with all of the in this part which are in terms applicable to applicable regulations of the U.S. Fish such importations. and Wildlife Service contained in Title

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50, subchapter B, of the Code of Federal and slaughter thereat within two Regulations. weeks from the date of entry. Inspector. An employee of the Animal [55 FR 31495, Aug. 2, 1990, as amended at 61 and Plant Health Inspection Service FR 68126, Dec. 27, 1996. Redesignated and amended at 56012, 56015, Oct. 28, 1997; 65 FR authorized to perform duties required 38178, June 20, 2000; 67 FR 68022, Nov. 8, 2002] under this subpart. Operator. For the purpose of § 93.209, any person operating an approved quar- Subpart B—Poultry antine facility. § 93.200 Definitions. Performing or theatrical poultry. Poul- try which are to be used in shows, the- Wherever in this subpart the fol- atrical acts or performances only. lowing terms are used, unless the con- Port veterinarian. A veterinarian em- text otherwise requires, they shall be ployed by the Animal and Plant Health construed, respectively, to mean: Inspection Service to perform duties Accredited veterinarian. A veteri- required under this part at a port of narian approved by the Administrator entry. in accordance with the provisions of Poultry. Chickens, doves, ducks, part 161 of this title to perform func- geese, grouse, guinea fowl, partridges, tions specified in parts 1, 2, 3, and 11 of pea fowl, pheasants, pigeons, quail, subchapter A, and subchapters B, C, swans, and turkeys (including eggs for and D of this chapter, and to perform hatching). functions required by cooperative Region. Any defined geographic land state-federal disease control and eradi- area identifiable by geological, polit- cation programs. ical, or surveyed boundaries. A region Administrator. The Administrator of may consist of any of the following: the Animal and Plant Health Inspec- (1) A national entity (country); tion Service or any other employee of (2) Part of a national entity (zone, the Animal and Plant Health Inspec- county, department, municipality, par- tion Service, United States Depart- ish, Province, State, etc.) ment of Agriculture, to whom author- (3) Parts of several national entities ity has been or may be delegated to act combined into an area; or in the Administrator’s stead. (4) A group of national entities (coun- Animal and Plant Health Inspection tries) combined into a single area. Service. The Animal and Plant Health Swine. The domestic hog and all vari- Inspection Service of the United States eties of wild hogs. Department of Agriculture (APHIS or United States. All of the States of the Service). United States, the District of Colum- Animals. Cattle, sheep, goats, other bia, Guam, Northern Mariana Islands, ruminants, swine, horses, asses, mules, Puerto Rico, the Virgin Islands of the zebras, dogs, and poultry. United States, and all other Territories Communicable disease. Any con- and Possessions of the United States. tagious, infectious, or communicable Veterinary services. The Veterinary disease of domestic livestock, poultry Services unit of the Department. or other animals. [55 FR 31495, Aug. 2, 1990. Redesignated and Department. The United States De- amended at 62 FR 56012, 56015, Oct. 28, 1997] partment of Agriculture (USDA). Fever tick. Boophilus annulatus, in- § 93.201 General prohibitions; excep- cluding, but not limited to, the vari- tions. eties Americana and Australia. (a) No poultry or product subject to Immediate slaughter. Consignment di- the provisions of this part shall be rectly from the port of entry to a rec- brought into the United States except ognized slaughtering establishment 1 in accordance with the regulations in this part and part 94 of this sub- 2 1 The name of recognized slaughtering es- chapter; nor shall any such poultry or tablishments approved under this part may be obtained from the Area Veterinarian in 2 Importations of certain animals from var- Charge, Veterinary Services, for the State of ious regions are absolutely prohibited under destination of the shipment. part 94 because of specific diseases.

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product be handled or moved after tation from the United States and are physical entry into the United States maintained under continuous confine- before final release from quarantine or ment aboard such means of conveyance any other form of governmental deten- until it leaves the United States; the tion except in compliance with such import permit will specify any addi- regulations; Provided, That, the Admin- tional conditions necessary to assure istrator may upon request in specific that the transit of the poultry through cases permit poultry or products to be the United States can be made without brought into or through the United endangering the livestock or poultry of States under such conditions as he or the United States, and that Depart- she may prescribe, when he or she de- ment inspectors may inspect the poul- termines in the specific case that such try on board such means of conveyance action will not endanger the livestock or in such holding facility to ascertain or poultry of the United States. No live whether the requirements of this para- poultry, and no hatching eggs from graph are met, and dispose of them in poultry, shall be imported into the accordance with the Animal Health United States if the poultry have been Protection Act (7 U.S.C. 8301 et seq.) if vaccinated for the H5 or H7 subtype of such conditions are not met; and avian influenza. (2) The carrier or its agent executes (b) The provisions in this part 93 re- and furnishes to the collector of Cus- lating to poultry shall not apply to toms at the first port of arrival a dec- healthy poultry not known to be in- laration stating that the poultry will fected with or exposed, within the 90 be retained aboard such means of con- days preceding the date of export from veyance or in an approved holding fa- the region of origin, to communicable cility during transshipment as required diseases of poultry, if an import per- by this paragraph. mit 3 has been obtained under § 93.204 of (3) Provisions for the approval of fa- this chapter and all conditions therein cilities required in this paragraph are: are observed; and if such poultry are (i) They must be sufficiently isolated handled as follows: to prevent direct or indirect contact (1)(i) They are maintained under con- with all other animals and birds while tinuous confinement in transit through in the United States. the United States aboard an aircraft, (ii) They must be so constructed that ocean vessel, or other means of convey- they provide adequate protection ance; or against environmental conditions and (ii) Except for poultry in transit can be adequately cleaned, washed and through Anchorage, Alaska, under disinfected. § 93.204(c) of this part, which are not al- (iii) They must provide for disposal of lowed to be unloaded, they are un- animal and bird carcasses, manure, loaded, in the course of such transit, bedding, waste and any related ship- into an animal or bird holding facility ping materials in a manner that will which is provided by the carrier or its prevent dissemination of disease. 4 agent and has been approved in ad- (iv) They must have provisions for vance by the Administrator in accord- adequate sources of feed and water and ance with paragraph (b)(3) of this sec- for attendants for the care and feeding tion as adequate to prevent the spread of poultry in the facility. within the United States of any live- (v) They must comply with addi- stock or poultry disease, and they are tional requirements as may be imposed maintained there under continuous by the Administrator if deemed appli- confinement until loaded aboard a cable for a particular shipment. means of conveyance for transpor- (vi) They must also comply with all applicable local, State and Federal re- 3 Such permit may be obtained from the quirements for environmental quality Animal and Plant Health Inspection Service, and with the provisions of the Animal Veterinary Services, National Center for Im- Welfare Regulations in chapter I of this port-Export, 4700 River Road Unit 38, River- dale, Maryland 20737–1231. Requests for ap- title, as applicable. proval of such facilities should also be made (c) Performing or theatrical poultry re- to the Deputy Administrator. turning to the United States. (1) Per- 4 See footnote 3 in subpart B. forming or theatrical poultry of United

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States origin that are returning to the released at the end of such period by United States from Canada or Mexico such an inspector; and may be imported if: (2) That appropriate Federal officials (i) The poultry are found upon port of in the State of destination will be im- entry veterinary inspection to be free mediately notified if any signs of dis- of poultry diseases; and ease are noted in any of the poultry or (ii) The poultry are accompanied by a any poultry die during that period. The United States veterinary health certifi- owner importing such poultry must cate issued prior to the departure of comply with the provisions of the the poultry from the United States and aforementioned agreement before the the certificate shows the number from poultry may be released from confine- the leg band, tattoo, or microchip af- ment. fixed to the poultry prior to departure; (3) Any performing or theatrical and poultry of United States origin that (iii) During port of entry veterinary have been in any region listed in inspection it is determined that the § 94.6(d) of this subchapter as a region number from the leg band, tattoo, or where highly pathogenic avian influ- microchip on the poultry is the same enza exists may only be imported as the one listed on the health certifi- through the port of Los Angeles, CA, cate. Miami, FL, or New York, NY, and only (2) Except for performing or theat- under the following conditions: rical poultry that have been in any re- (i) The poultry meet the require- gion where highly pathogenic avian in- ments of paragraphs (c)(1)(i) through fluenza exists, which are subject to the (iii) of this section; and provisions of paragraph (c)(3) of this (ii) The poultry are accompanied by section, performing or theatrical poul- an import permit issued by APHIS; and try of United States origin that have been outside the United States in a re- (iii) The poultry are quarantined for gion other than Canada or Mexico may a minimum of 30 days, and for such be imported if: longer period as may be required by the (i) The poultry meet the require- Administrator in any specific case, at a ments of paragraphs (c)(1)(i) through quarantine facility maintained by (iii) of this section; and APHIS in accordance with §§ 93.209 and (ii) The poultry are accompanied by 93.210. an import permit issued by APHIS; and (d) The provisions in this part relat- (iii) The owner importing the poultry ing to poultry shall not be applicable signs and furnishes to the Adminis- to performing or theatrical poultry. trator the following: (Approved by the Office of Management and (A) A notarized declaration under Budget under control number 0579–0245) oath or affirmation (or a statement [55 FR 31495, Aug. 2, 1990. Redesignated and signed by the owner and witnessed by a amended at 56012, 56015, Oct. 28, 1997; 68 FR Department inspector) stating that the 6344, Feb. 7, 2003; 69 FR 25825, May 10, 2004; 76 poultry have not been in contact with FR 4053, Jan. 24, 2011] poultry or other birds while out of the region (for example, association with § 93.202 Inspection of certain aircraft other avian species at exhibitions or at and other means of conveyance and aviaries); and shipping containers thereon; un- (B) An agreement on VS Form 17–8, loading, cleaning, and disinfection obtainable from a Federal inspector at requirements. the port of entry, stating: (a) Inspection: All aircraft and other (1) That the poultry will be main- means of conveyance (including ship- tained in confinement in his or her per- ping containers thereon) moving into sonal possession separate and apart the United States from any foreign re- from all poultry and other birds for a gion are subject to inspection without minimum of 30 days following importa- a warrant by properly identified and tion at the address where the poultry designated inspectors to determine are to be held and made available for whether they are carrying any animal, health inspection and testing by De- carcass, product or article regulated or partment inspectors upon request until subject to disposal under any law or

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regulation administered by the Sec- § 93.203 Ports designated for the im- retary of Agriculture for prevention of portation of poultry. the introduction or dissemination of (a) Air and ocean ports. The following any communicable animal disease. ports have APHIS inspection and quar- (b) Unloading requirements: Whenever antine facilities necessary for quar- in the course of any such inspection at antine stations and all poultry shall be any port in the United States the in- entered into the United States through spector has reason to believe that the these stations, except as provided in means of conveyance or container is paragraphs (b), (c), (d) and (e) of this contaminated with material of animal section: Los Angeles, California; (including poultry) origin, such as, but Miami, Florida; and Newburgh, New not limited to, meat, organs, glands, York. extracts, secretions, fat, bones, blood, (b) Canadian border ports. The following land border ports are designated lymph, urine, or manure, so as to as having the necessary inspection fa- present a danger of the spread of any cilities for the entry of poultry from communicable animal disease, the in- Canada: Eastport, Idaho; Houlton and spector may require the unloading of Jackman, Maine; Detroit, Port Huron, the means of conveyance and the and Sault Ste. Marie, Michigan; emptying of the container if he or she Baudette, Minnesota; Opheim, Ray- deems it necessary to enable him or mond, and Sweetgrass, Montana; Alex- her to determine whether the means of andria Bay, Buffalo, and Champlain, conveyance or container is in fact so New York; Dunseith, Pembina, and contaminated. The principal operator Portal, North Dakota; Derby Line and of the means of conveyance and his or Highgate Springs, Vermont; Oroville her agent in charge of the means of and Sumas, Washington. conveyance shall comply with any such (c) Mexican border ports. The fol- requirement under the immediate su- lowing land border ports are designated pervision of, and in the time and man- as having the necessary inspection fa- ner prescribed by, the inspector. cilities for the entry of poultry from (c) Cleaning and disinfection: When- Mexico: Brownsville, Hidalgo, Laredo, ever, upon inspection under this sec- Eagle Pass, Del Rio, Presidio, and El tion, an inspector determines that a Paso, Texas; Douglas, Naco, Nogales, Sasabe, and San Luis, Arizona; means of conveyance or shipping con- Calexico and San Ysidro, California; tainer is contaminated with material and Antelope Wells, and Columbus, of animal origin so as to present a dan- New Mexico. ger of the spread of any communicable (d) Limited ports. The following ports animal disease, he or she shall notify are designated as having inspection fa- the principal operator of the means of cilities for the entry of poultry and conveyance or his or her agent in poultry products such as poultry test charge, of such determination and the specimens, or hatching eggs and day requirements under this section. The old chicks which do not appear to re- person so notified shall cause the quire restraint and holding inspection cleaning and disinfection of such facilities: Anchorage and Fairbanks, means of conveyance and container Alaska; San Diego, California; Jack- under the immediate supervision of, sonville, Port Canaveral, St. Peters- and in the time and manner prescribed burg-Clearwater, and Tampa, Florida; by, the inspector. Atlanta, Georgia; Honolulu, Hawaii; (d) For purposes of this section, the Chicago, Illinois; New Orleans, Lou- term ‘‘shipping container’’ means any isiana; Portland, Maine; Baltimore, container of a type specially adapted Maryland; Minneapolis, Minnesota; for use in transporting any article on Great Falls, Montana; Portland, Or- the means of conveyance involved. egon; San Juan, Puerto Rico; Gal- veston and Houston, Texas; and Se- [55 FR 31495, Aug. 2, 1990, as amended at 59 attle, Spokane, and Tacoma, Wash- FR 67614, Dec. 30, 1994. Redesignated and ington. amended at 62 FR 56012, 56015, Oct. 28, 1997; 68 (e) Designation of other ports. The Sec- FR 6344, Feb. 7, 2003] retary of the Treasury has approved

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the designation as quarantine stations been or will be held or through which of the ports specified in this section. In the shipment has been or will be trans- special cases other ports may be des- ported; deficiencies in the regulatory ignated as quarantine stations under programs for the control or eradication this section by the Administrator, with of animal diseases and the unavail- the concurrence of the Secretary of the ability of veterinary services in the Treasury. above mentioned regions; the import- [55 FR 31495, Aug. 2, 1990, as amended at 58 er’s failure to provide satisfactory evi- FR 37642, July 13, 1993; 60 FR 16045, Mar. 29, dence concerning the origin, history, 1995; 60 FR 25120, May 11, 1995. Redesignated and health status of the poultry; the at 56012, Oct. 28, 1997, as amended at 65 FR lack of satisfactory information nec- 38178, June 20, 2000; 67 FR 6370, Feb. 12, 2002; 67 FR 68022, Nov. 8, 2002] essary to determine that the importation will not be likely to transmit any § 93.204 Import permits for poultry communicable disease to livestock or and for poultry test specimens for poultry of the United States; or any diagnostic purposes; and reserva- other circumstances which the Admin- tion fees for space at quarantine facilities maintained by APHIS. istrator believes require such denial to prevent the dissemination of any com- (a) Application for permit; reservation municable disease of livestock or poul- required. (1) For poultry and poultry try into the United States. test specimens for diagnostic screening purposes, intended for importation (3)(i) The importer or importer’s from any part of the world, except as agent shall pay or ensure payment of a otherwise provided for in §§ 93.204(c), reservation fee for each lot of poultry 93.214, 93.217, and 93.218, the importer to be quarantined in a facility main- shall first apply for and obtain from tained by USDA. For poultry, the res- APHIS an import permit. The applica- ervation fee shall be 100 percent of the tion shall specify the name and address cost of providing care, feed, and han- of the importer; the species, breed, dling during quarantine, as estimated number or quantity of poultry or poul- by the quarantine facility’s veteri- try test specimens to be imported; the narian in charge. purpose of the importation; the region (ii) At the time the importer or the of origin; the name and address of the importer’s agent requests a reservation exporter; the port of embarkation in of quarantine space, the importer or the foreign region; the mode of trans- importer’s agent shall pay the reserva- portation, route of travel, and the port tion fee by check or U.S. money order of entry in the United States; the pro- or ensure payment of the reservation posed date of arrival of the poultry or poultry test specimens to be imported; fee by an irrevocable letter of credit and the name of the person to whom from a commercial bank (the effective the poultry or poultry test specimens date on such letter of credit shall run will be delivered and the location of to 30 days after the date the poultry the place in the United States to which are scheduled to be released from quar- delivery will be made from the port of antine); except that anyone who issues entry. Additional information may be a check to the Department for a res- required in the form of certificates ervation fee which is returned because concerning specific diseases to which of insufficient funds shall be denied the poultry are susceptible, as well as any further request for reservation of a vaccinations or other precautionary quarantine space until the outstanding treatments to which the poultry or amount is paid. poultry test specimens have been sub- (iii) Any reservation fee paid by jected. Notice of any such requirement check or U.S. money order shall be ap- will be given to the applicant in each plied against the expenses incurred for case. services received by the importer or (2) An application for permit to im- importer’s agent in connection with port poultry may also be denied be- the quarantine for which the reserva- cause of: Communicable disease condition was made. Any part of the reservations in the area or region of origin, or in a region where the shipment has tion fee which remains unused after

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being applied against the expenses in- this section, the Department will draw curred for services received by the im- against the letter of credit unless the porter or the importer’s agent in con- reservation fee is otherwise paid at nection with the quarantine for which least 3 days prior to the expiration the reservation was made, shall be re- date of the letter of credit. turned to the individual who paid the (vi) When a reservation is cancelled reservation fee. If the reservation fee is in accordance with paragraph ensured by a letter of credit, the De- (a)(3)(iv)(A) of this section and the pro- partment will draw against the letter visions of paragraph (a)(3)(iv)(B) of this of credit unless payment for services section do not apply, a $40.00 cancella- received by the importer or importer’s tion fee shall be charged. If a reserva- agent in connection with the quar- tion fee was paid, the cancellation fee antine is otherwise made at least 3 shall be deducted from any reservation days prior to the expiration date of the fee returned to the importer or the im- letter of credit. porter’s agent. If the reservation fee (iv) Any reservation fee shall be for- was ensured by a letter of credit, the feited if the importer or the importer’s Department will draw the amount of agent fails to present for entry, within the cancellation fee against the letter 24 hours following the designated time of credit unless the cancellation fee is of arrival, the lot of poultry for which otherwise paid at least 3 days prior to the reservation was made: Except that the expiration date of the letter of a reservation fee shall not be forfeited credit. if: (b) Permit. Except as provided in (A) Written notice of cancellation paragraph (c) of this section, when a from the importer or the importer’s permit is issued, the original and two agent is received by the office of the copies will be sent to the importer. It veterinarian in charge of the quar- shall be the responsibility of the im- 5 antine facility during regular business porter to forward the original permit hours (8:00 a.m. to 4:30 p.m., Monday and one copy to the shipper in the re- through Friday, excluding holidays) no gion of origin, and it shall also be the later than 15 days prior to the begin- responsibility of the importer to insure ning of the time of importation as that the shipper presents the copy of specified in the import permit or as ar- the permit to the carrier and makes ranged with the veterinarian in charge proper arrangements for the original of the quarantine facility if no import permit to accompany the shipment to permit is required (the 15 day period the specified U.S. port of entry for shall not include Saturdays, Sundays, presentation to the collector of cus- or holidays), or toms. Poultry and poultry test speci- (B) The Administrator determines mens for diagnostic screening purposes that services, other than provided by for poultry intended for importation carriers, necessary for the importation into the United States for which a per- of the poultry within the requested pe- mit has been issued, will be received at riod are unavailable because of unfore- the specified port of entry within the seen circumstances as determined by time prescribed in the permit which the Administrator, (such as the closing shall not exceed 14 days from the first of an airport due to inclement weather day that the permit is effective for all or the unavailability of the reserved permits, except that the time pre- space due to the extension of another scribed in permits from the importa- quarantine). tion of poultry shall not exceed 30 (v) If the reservation fee was ensured days, and for performing or theatrical by a letter of credit and the fee is to be poultry shall not exceed 90 days. Poul- forfeited under paragraph (a)(3)(iv) of try and poultry test specimens for which a permit is required by these 5 The addresses of USDA quarantine facili- regulations will not be eligible for ties may be found in telephone directories entry if a permit has not been issued; if listing the facilities or by contacting the Animal and Plant Health Inspection Service, unaccompanied by such a permit; if Veterinary Services, National Center for Im- shipment is from any port other than port-Export, 4700 River Road Unit 38, River- the one designated in the permit; if ar- dale, Maryland 20737–1231. rival in the United States is at any

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port other than the one designated in (vi) The proposed date of arrival of the permit; if the poultry or poultry the poultry or pigeons; and test specimens offered for entry differ (vii) The name and address of the per- from those described in the permit; or son to whom the poultry or pigeons if the poultry or poultry test specimens will be delivered. are not handled as outlined in the ap- (3) The importer, not less than 2 plication for the permit and as speci- weeks prior to the anticipated date of fied in the permit issued. arrival of each separate intransit ship- (c) Notwithstanding any other provi- ment of poultry or pigeons at the port sions in this part, importers are not re- of Anchorage, Alaska, provides the quired to obtain an import permit and port veterinarian with a copy of the provide the shipper with an original completed import permit; import permit for each individual ship- (4) A copy of the completed import ment of poultry or pigeons transiting permit accompanies each separate the port of Anchorage, Alaska, if the intransit shipment of poultry or pi- following conditions are met: geons to the port of Anchorage, Alas- (1) The importer applies for and ob- ka; tains an import permit for multiple (5) Import permits issued for mul- shipments of poultry or pigeons tiple shipments of poultry or pigeons transiting the port of Anchorage, Alas- transiting the port of Anchorage, Alas- ka, in accordance with the provisions ka, will be valid only during the cal- of this section and related require- endar year in which they are issued. ments concerning application for the permit. However, the following infor- [55 FR 31495, Aug. 2, 1990, as amended at 59 mation is not required on the applica- FR 67614, Dec. 30, 1994. Redesignated and tion: amended at 56012, 56015, Oct. 28, 1997] (i) The species, breed, and number of § 93.205 Certificate for live poultry and poultry or pigeons to be imported; hatching eggs. (ii) The individual poultry identification; (a) Live poultry. All live poultry, ex- (iii) The region of origin; cept eggs for hatching, offered for im- (iv) The name and address of the exportation from any region of the world porter; shall be accompanied by a certificate stating that such poultry and their (v) The port of embarkation in the flock or flocks of origin were inspected foreign region; on the premises of origin immediately (vi) The mode of transportation and before the date of movement from such the route of travel; region and that they were then found (vii) The proposed date of arrival of to be free of evidence of communicable the poultry or pigeons; and diseases of poultry. The certificate (viii) The name and address of the shall also state that, as far as it has person to whom the poultry or pigeons been possible to determine, during the will be delivered. 90 days prior to movement, the poultry (2) The importer completes a copy of were not exposed to communicable dis- the import permit obtained under para- eases of poultry and the premises were graph (c)(1) of this section for each sep- not in any area under quarantine. The arate shipment of poultry or pigeons certificate shall also state that the intended to transit the port of Anchor- poultry have not been vaccinated with age, Alaska, by inserting the following a vaccine for the H5 or H7 subtype of information on a copy of the permit: avian influenza. The certificate shall (i) The species, breed, and number of also state that the poultry have been poultry or pigeons to be imported; kept in the region from which they are (ii) The region of origin; offered for importation since they were (iii) The name and address of the ex- hatched, or for at least 90 days imme- porter; diately preceding the date of move- (iv) The port of embarkation in the ment, that the poultry have not been foreign region; moved through a region identified in (v) The mode of transportation and accordance with § 94.6(a) of this sub- the route of travel; chapter as a region where any form of

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highly pathogenic avian influenza ex- ered, and the location of the place to ists, and that, as far as it has been pos- which such delivery will be made. sible to determine, no case of European fowl pest (fowl plague) or Newcastle § 93.207 Inspection at the port of disease occurred on the premises where entry. such poultry were kept, or on adjoining Inspection shall be made at the port premises, during that 90-day period. of entry of all poultry imported from (b) Hatching eggs. All eggs for hatch- any part of the world except as pro- ing offered for importation from any vided in §§ 93.215 and 93.220. All poultry part of the world shall be accompanied found to be free from communicable by a certificate stating that the flock disease and not to have been exposed or flocks of origin were found upon in- thereto within 90 days prior to their spection to be free from evidence of exportation to the United States shall communicable diseases of poultry, the be admitted subject to the other provi- hatching eggs are from poultry that sions in this part; all other poultry have not been vaccinated with a vac- shall be refused entry. Poultry refused cine for the H5 or H7 subtype of avian entry, unless exported within a time influenza and that during the 90 days fixed in each case by the Adminis- prior to movement, the flock or flocks trator, and in accordance with other of origin were not exposed to commu- provisions he or she may require in nicable diseases of poultry and the each case for their handling shall be premises were not in any area under disposed of as the Administrator may quarantine. direct. Such portions of the trans- (c) Nature of certificate. The certifi- porting vessel, and of its cargo, which cate required by this section shall be have been exposed to any such poultry issued by a salaried veterinary officer or their emanations shall be dis- of the national government of the re- infected in such manner as may be con- gion of origin, or if the articles are ex- sidered necessary by the inspector in ported from Mexico, may alternatively charge at the port of entry, to prevent be issued by a veterinarian accredited the introduction or spread of livestock by the National Government of Mexico or poultry disease, before the cargo is and endorsed by a full-time salaried allowed to land. veterinary officer of the National Gov- [55 FR 31495, Aug. 2, 1990. Redesignated and ernment of Mexico, thereby rep- amended at 56012, 56015, Oct. 28, 1997; 68 FR resenting that the veterinarian issuing 6344, Feb. 7, 2003] the certificate was authorized to do so. § 93.208 Articles accompanying poul- [76 FR 4053, Jan. 24, 2011] try. No litter or manure, fodder or other § 93.206 Declaration and other docu- aliment, nor any equipment such as ments for poultry. boxes, buckets, ropes, chains, blankets, (a) The certificates, declarations, and or other things used for or about poul- affidavits required by the regulations try governed by the regulations this in this part shall be presented by the part, shall be landed from any convey- importer or his or her agent to the col- ance except under such restrictions as lector of customs at the port of entry, the inspector in charge at the port of upon arrival of poultry at such port, entry shall direct. for the use of the veterinary inspector at the port of entry. § 93.209 Quarantine requirements. (b) For all poultry offered for impor- (a) Poultry, other than eggs for tation, the importer or his or her agent hatching, imported, except as provided shall first present two copies of a dec- in § 93.216 of this part, shall be quar- laration which shall list the port of antined for not less than 30 days, entry, the name and address of the im- counting from the date of arrival at porter, the name and address of the the port of entry. During their quar- broker, the origin of the poultry, the antine, such poultry shall be subject to number, breed, species, and purpose of any inspections, disinfections, and the importation, the name of the per- tests as may be required by the Admin- son to whom the poultry will be deliv- istrator, to determine their freedom

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from communicable diseases of poul- the poultry may be disposed of as the try, and their freedom from exposure Administrator, may direct, including to such diseases. sale in accordance with the procedure (b) Poultry eggs for hatching im- described in paragraph (b) of this sec- ported, except from regions designated tion. The importer, or his or her agent, in § 94.6(a) of this subchapter as free of shall request in writing such inspection exotic Newcastle disease and highly and other services as may be required, pathogenic avian influenza, shall be and shall waive all claim against the quarantined from time of arrival at the United States and APHIS or any em- port of entry until hatched and the ployee of APHIS for damages which poultry from such eggs shall remain may arise from such services. The Ad- quarantined for not less than 30 days ministrator may prescribe reasonable following hatch. During their quar- rates for the services provided under antine, such eggs for hatching and this paragraph. When it is found nec- poultry from such eggs shall be subject essary to extend the usual minimum to any inspections, disinfections, and quarantine period, the importer, or his tests as may be required by the Admin- or her agent, shall be so advised in istrator, to determine their freedom writing and shall pay for such addi- from communicable diseases of poul- tional quarantine and other services try. required. Payment for all services re- [55 FR 31495, Aug. 2, 1990, as amended at 61 ceived by the importer, or his or her FR 56891, Nov. 5, 1996. Redesignated and agent, in connection with each sepa- amended at 62 FR 56012, 56015, Oct. 28, 1997; 76 rate lot of poultry shall be made by FR 4054, Jan. 24, 2011] certified check or U.S. money order prior to release of the poultry. If such § 93.210 Poultry quarantine facilities. payment is not made, the poultry may (a) Privately operated quarantine facili- be sold in accordance with the proce- ties. The importer, or his or her agent, dure described in paragraph (b) of this of poultry subject to quarantine under section, or otherwise disposed of as di- the regulations in this part shall ar- rected by the Administrator. range for acceptable transportation to (b) Quarantine facilities maintained by the privately operated quarantine fa- APHIS. The importer, or his or her cility and for the care, feed, and han- agent, of poultry subject to quarantine dling of the poultry from the time of under the regulations in this part shall unloading at the quarantine port to the arrange for acceptable transportation time of release from quarantine. Such to the quarantine facility, and for the arrangements shall be agreed to in ad- care, feed, and handling of the poultry vance by the Administrator. All ex- from the time they arrive at the quar- penses resulting therefrom or incident antine port to the time of release from thereto shall be the responsibility of quarantine. Such arrangements shall the importer; APHIS assumes no re- be agreed to in advance by the Admin- sponsibility with respect thereto. The istrator. The importer or his or her quarantine facility must be suitable for agent shall request in writing such in- the quarantine of such poultry and spection and other services as may be must be approved by the Administrator required, and shall waive all claim prior to the issuance of any import per- against the United States and APHIS mit. The facilities occupied by poultry or any employee of APHIS, for dam- should be kept clean and sanitary to ages which may arise from such serv- the satisfaction of the inspector as- ices. All expenses resulting therefrom signed to supervise the quarantine. If or incident thereto shall be the respon- for any cause the care, feed, or han- sibility of the importer; APHIS as- dling of poultry, or the sanitation of sumes no responsibility with respect the facilities, is neglected, in the opin- thereto. The Administrator may pre- ion of the inspector assigned to super- scribe reasonable rates for the services vise the quarantine, such services may provided under this paragraph. When it be furnished by APHIS in the same is found necessary to extend the usual manner as though arrangements had minimum quarantine period, the im- been made for such services as provided porter, or his or her agent, shall be so by paragraph (b) of this section, and/or advised in writing and shall pay for

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such additional quarantine and other quarantine period, owners, officers or services required. Payment for services registry societies, and others having received by the importer, or his or her official business or whose services may agent, in connection with each sepa- be necessary in the removal of the rate lot of poultry shall be made by poultry may be admitted upon written certified check or U.S. money order permission from the said inspector. No prior to release of the poultry. If such exhibition or sale shall be allowed payment is not made, the poultry may within the quarantine grounds. be sold in accordance with the procedure described in this paragraph or § 93.212 Manure from quarantined otherwise disposed of as directed by the poultry. Administrator. When payment is not No manure shall be removed from the made and the poultry are to be sold to quarantine premises until the release recover payment for services received, of the poultry producing same. the importer, or his or her agent, will be notified by the inspector that if said § 93.213 Appearance of disease among charges are not immediately paid or poultry in quarantine. satisfactory arrangements made for payment, the poultry will be sold at If any contagious disease appears public sale to pay the expense of care, among poultry during the quarantine feed, and handling during that period. period special precautions shall be The sale will be held after the expira- taken to prevent spread of the infection of the quarantine period, at such tion to other poultry in the quarantine time and place as may be designated by station or to those outside the grounds. the General Services Administration or The affected poultry shall be disposed other designated selling agent. The of as the Administrator may direct, de- proceeds of the sale, after deducting pending upon the nature of the disease. the charges for care, feed, and handling 6 of the poultry and other expenses, in- CANADA cluding the expense of the sale, shall be held in a Special Deposit Account in § 93.214 Import permit and declaration for poultry. the United States Treasury for 6 months from the date of sale. If not (a) For poultry intended for importa- claimed by the importer, or his or her tion from Canada, the importer shall agent, within 6 months from the date first apply for and obtain from APHIS of sale, the amount so held shall be an import permit as provided in § 93.204: transferred from the Special Deposit Provided, That an import permit is not Account to the General Fund Account required for poultry if offered for entry in the United States Treasury. at a land border port designated in (c) Amounts collected from the im- § 93.203(b). porter, or his or her agent, for service (b) For all poultry offered for impor- rendered shall be deposited so as to be tation from Canada, the importer or available for defraying the expenses in- his or her agent shall present two cop- volved in this service. ies of a declaration as provided in § 93.206. § 93.211 Quarantine stations, visiting restricted; sales prohibited. [55 FR 31495, Aug. 2, 1990. Redesignated and Visitors shall not be admitted to the amended at 62 FR 56012, 56015, Oct. 28, 1997] quarantine enclosure during any time that poultry are in quarantine except § 93.215 Special provisions. that an importer (or his or her accred- (a) In-bond shipments from Canada. (1) ited agent or veterinarian) may be ad- Poultry from Canada transported in- mitted to the yards and buildings con- bond through the United States for im- taining his or her quarantined poultry mediate export shall be inspected at at such intervals as may be deemed necessary, and under such conditions 6 Importations from Canada shall be sub- and restrictions as may be imposed, by ject to §§ 93.214 to 93.216, inclusive, in addi- the inspector in charge of the quar- tion to other sections in this part which are antine station. On the last day of the in terms applicable to such importations.

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the border port of entry and, when ac- upon examination by the veterinary in- companied by an import permit ob- spector at the U.S. port of entry, are tained under § 93.204 of this part and all found by the inspector to be free of conditions therein are observed, shall communicable diseases and exposure be allowed entry into the United States thereto and are determined to be the and shall be otherwise handled as pro- identical poultry covered by said cer- vided in paragraph (b) of § 93.201. Poul- tificates or that they otherwise quali- try not accompanied by a permit shall fied for entry into Canada under the meet the requirements of this part in Canadian regulations. the same manner as poultry destined (Approved by the Office of Management and for importation into the United States, Budget under control number 0579–0020) except that the Administrator may [55 FR 31495, Aug. 2, 1990, as amended at 59 permit their inspection at some other FR 67133, Dec. 29, 1994. Redesignated and point when he or she finds that such amended at 62 FR 56012, 56015, Oct. 28, 1997] action will not increase the risk that communicable disease of livestock and § 93.216 Poultry from Canada. poultry will be disseminated to the Poultry imported from Canada is not livestock or poultry of the United required to meet the requirements of States. § 93.209 but shall meet all other require- (2) In-transit shipments through Can- ments of this part applicable to poultry ada. Poultry originating in the United or to animals generally. States and transported directly through Canada may re-enter the [55 FR 31495, Aug. 2, 1990. Redesignated and United States without Canadian health amended at 62 FR 56012, 56015, Oct. 28, 1997] or test certificates when accompanied CENTRAL AMERICA AND THE WEST by copies of the United States export INDIES 7 health certificates properly issued and endorsed in accordance with regula- § 93.217 Import permit and declaration tions in part 91 of this chapter: Pro- for poultry. vided, That, to qualify for entry, the (a) For poultry intended for importa- date, time, port of entry, and signature tion from regions of Central America of the Canadian Port Veterinarian that or of the West Indies, the importer inspected the poultry for entry into shall first apply for and obtain from Canada shall be recorded on the United APHIS an import permit as provided in States health certificate, or a paper § 93.204: Provided, That the Adminis- containing the information shall be at- trator, when he or she finds that such tached to the certificate that accom- action may be taken without endan- panies the poultry. In all cases it shall gering the livestock or poultry indus- be determined by the veterinary in- try of the United States, may, upon re- spector at the United States port of quest by any person, authorize the im- entry that the poultry are the identical portation by such person, without such poultry covered by said certificate. application or permit, from the British (b) Exhibition poultry. Poultry from Virgin Islands into the Virgin Islands the United States which have been ex- of the United States, of poultry con- hibited at the Royal Agricultural Win- signed for immediate slaughter, and ter Fair at Toronto or other publicly such authorization may be limited to a recognized expositions in Canada, in- particular shipment or extend to all cluding racing, rodeo, circus, or stage shipments under this paragraph by exhibitions in Canada, and have not such person during a specified period of been in that region for more than 90 time. days are eligible for return to the (b) For all poultry offered for impor- United States without Canadian health tation from regions of Central America or test certificates, if they are accom- or of the West Indies, the importer or panied by copies of the United States health certificate, issued and endorsed 7 Importations from regions of Central in accordance with the export regula- America and the West Indies shall be subject tions contained in part 91 of this chap- to § 93.217, in addition to other sections in ter for entry into Canada: Provided, this part, which are in terms applicable to That all poultry offered for re-entry such importations.

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his or her agent shall present two cop- disease and fever tick infestation and ies of a declaration as provided in not to have been exposed thereto, shall § 93.206. be admitted into the United States (c) All poultry offered for importa- subject to the other applicable provi- tion from regions of Central America sions of this part. Poultry found to be and the West Indies shall also meet the affected with or to have been exposed additional requirements in §§ 93.205, to a communicable disease, or infested 93.207, 93.209, and 93.210 to qualify for with fever ticks, shall be refused entry. entry. All poultry which fail to meet Poultry refused entry, unless exported these requirements shall be rejected within a time fixed in each case by the entry and shall be disposed of as di- Administrator, shall be disposed of as rected by the Administrator in accord- said Administrator may direct. ance with applicable laws. (b) Poultry covered by paragraph (a) [55 FR 31495, Aug. 2, 1990. Redesignated and of this section shall be imported amended at 62 FR 56012, 56015, Oct. 28, 1997] through ports designated in § 93.203. [55 FR 31495, Aug. 2, 1990, as amended at 57 8 MEXICO FR 12190, Apr. 9, 1992. Redesignated and amended at 62 FR 56012, 56016, Oct. 28, 1997] § 93.218 Import permits and applications for inspection for poultry. Subpart C—Horses (a) For poultry intended for importation from Mexico, the importer shall § 93.300 Definitions. first apply for and obtain from APHIS an import permit as provided in § 93.204. Wherever in this subpart the fol- (b) For poultry intended for importa- lowing terms are used, unless the con- tion into the United States from Mex- text otherwise requires, they shall be ico, the importer or his or her agent construed, respectively, to mean: shall deliver to the veterinary inspec- Accredited veterinarian. A veteri- tor at the port of entry an application, narian approved by the Administrator in writing, for inspection, so that the in accordance with the provisions of veterinary inspector and customs rep- part 161 of this title to perform func- resentatives may make mutually satis- tions specified in parts 1, 2, 3, and 11 of factory arrangements for the orderly subchapter A, and subchapters B, C, inspection of the poultry. and D of this chapter, and to perform functions required by cooperative [55 FR 31495, Aug. 2, 1990. Redesignated and State-Federal disease control and amended at 62 FR 56012, 56016, Oct. 28, 1997] eradication programs. § 93.219 Declaration for poultry. Administrator. The Administrator of the Animal and Plant Health Inspec- For all poultry offered for importation Service or any other employee of tion from Mexico, the importer or his the Animal and Plant Health Inspec- or her agent shall present two copies of tion Service, United States Depart- a declaration as provided in § 93.206. ment of Agriculture, to whom author- [55 FR 31495, Aug. 2, 1990. Redesignated and ity has been or may be delegated to act amended at 62 FR 56012, 56016, Oct. 28, 1997] in the Administrator’s stead. Animals. Cattle, sheep, goats, other § 93.220 Inspection at port of entry. ruminants, swine, horses, asses, mules, (a) All poultry offered for entry from zebras, dogs, and poultry. Mexico, including such poultry in- Animal and Plant Health Inspection tended for movement through the Service. The Animal and Plant Health United States in bond for immediate Inspection Service of the United States return to Mexico, shall be inspected at Department of Agriculture (APHIS or the port of entry, and all such poultry Service). found to be free from communicable APHIS representative. A veterinarian or other individual employed by the 8 Importations from Mexico shall be sub- Animal and Plant Health Inspection ject to §§ 93.218 to 93.220 inclusive, in addition Service, United States Department of to other sections in this part which are in Agriculture, who is authorized to per- terms applicable for such importations. form the services required by this part.

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Code of practice. A voluntary system to horses, samples taken from horses, of procedures designed to reduce dis- and any other objects or substances ease spread, that is established by the that have been in the quarantine area veterinarians and horse industry in a during the quarantine of horses. region and that includes procedures for Operator. A person other than the the following: Testing for and treat- Federal Government who owns or man- ment of the diseases, quarantine of ages and has responsibility for the horses that are affected with or are services provided by a temporary, pri- suspected of being affected with the vately owned quarantine facility or a disease, certification of whether horses permanent, privately owned quarantine have been affected with or exposed to facility. the disease, and hygiene for personnel Permanent, privately owned quarantine conducting treatments and specimen facility. A facility that offers quar- collections. antine services for horses to the gen- Communicable disease. Any con- eral public on a continuing basis and tagious, infectious, or communicable that is owned and operated by an enti- disease of domestic livestock, poultry ty other than the Federal Government or other animals. (also permanent facility). Department. The United States De- Persons. Any individual, corporation, partment of Agriculture (USDA). company, association, firm, partner- Fever tick. Boophilus annulatus, in- ship, society or joint stock company. cluding, but not limited to, the vari- Port Veterinarian. A veterinarian em- eties Americana and Australia. ployed by the Animal and Plant Health Horses. Horses, asses, mules, and ze- Inspection Service to perform duties bras. required under this part at a port of Immediate slaughter. Consignment di- entry. rectly from the port of entry to a rec- Quarantine area. That area in a per- ognized slaughtering establishment 1 manent, privately owned quarantine and slaughter thereat within two facility that comprises all of the lot- weeks from the date of entry. holding areas in the facility, and any Inspector. An employee of the Animal other areas in the facility that horses and Plant Health Inspection Service have access to, including loading docks authorized to perform duties required for receiving and releasing horses, and under this subpart. any areas used to conduct examina- Licensed Veterinarian. Any person li- tions of horses and take samples and censed by any country or political sub- where samples are processed or exam- division thereof to practice veterinary ined. medicine. Recognized slaughtering establishment.2 Lot. A group of horses that, while An establishment where slaughtering held on a premises or conveyance, have operations are regularly carried on had opportunity for physical contact under federal or state inspection and with other horses in the group or with which has been approved by the Animal their excrement or discharges at any and Plant Health Inspection Service to time during their shipment to the receive animals for slaughter under United States. this part. Lot-holding area. That area in a per- Region. Any defined geographic land manent, privately owned quarantine area identifiable by geological, polit- facility in which a single lot of horses ical, or surveyed boundaries. A region is held at one time. may consist of any of the following: Nonquarantine area. That area in a (1) A national entity (country); permanent, privately owned quarantine (2) Part of a national entity (zone, facility that includes offices, storage county, department, municipality, par- areas, and other areas outside the quarantine area, and that is off limits ish, Province, State, etc.) (3) Parts of several national entities combined into an area; or 1 The name of recognized slaughtering es- (4) A group of national entities (coun- tablishments approved under this part may be obtained from the Area Veterinarian in tries) combined into a single area. Charge, Veterinary Services, for the State of destination of the shipment. 2 See footnote 1 to subpart C.

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State animal health official. The State upon request in specific cases permit official responsible for livestock and horses to be brought into or through poultry disease control and eradication the United States under such condi- programs. tions as he or she may prescribe, when Temporary, privately owned quarantine he or she determines in the specific facility. A facility that offers quar- case that such action will not endanger antine services for horses imported for the livestock or poultry of the United a specific event and that is owned and States. operated by an entity other than the (b) The provisions in this part 93 re- Federal Government (also temporary lating to horses shall not apply to facility). healthy horses in transit through the United States. All of the States of the United States if they are not known to United States, the District of Colum- be infected with or exposed, within 60 bia, Guam, Northern Mariana Islands, days preceding the date of export from Puerto Rico, the Virgin Islands of the the region of origin, to communicable United States, and all other Territories diseases of horses if an import permit 4 and Possessions of the United States. has been obtained under § 93.304 of this Veterinarian in Charge. The veteri- chapter and all conditions therein are nary official of the Animal and Plant observed; and if such horses are han- Health Inspection Service, United dled as follows: States Department of Agriculture, who (1)(i) They are maintained under con- is assigned by the Administrator to su- tinuous confinement in transit through pervise and perform the official animal the United States aboard an aircraft, health work of the Animal and Plant ocean vessel, or other means of convey- Health Inspection Service in the State ance; or concerned. (ii) They are unloaded, in the course Veterinary Services. The Veterinary of such transit, into a horse holding fa- Services unit of the Department. cility which is provided by the carrier 5 Weanling or yearling. Any horse, or its agent and has been approved in weaned from its dam, that was foaled advance by the Administrator in ac- not more than 731 days prior to its cordance with paragraph (b)(3) of this being offered for entry into the United section as adequate to prevent the States. A horse will not be considered spread within the United States of any to be a weanling or yearling if its first livestock or poultry disease, and they permanent incisors have erupted. are maintained there under continuous confinement until loaded aboard a [55 FR 31495, Aug. 2, 1990, as amended at 56 means of conveyance for transpor- FR 15489, Apr. 17, 1991; 61 FR 52239, Oct. 7, tation from the United States and are 1996. Redesignated and amended at 62 FR maintained under continuous confine- 56012, 56016, Oct. 28, 1997; 74 FR 31595, July 2, ment aboard such means of conveyance 2009] until it leaves the United States; the § 93.301 General prohibitions; excep- import permit will specify any additions. tional conditions necessary to assure that the transit of the horses through (a) No horse or product subject to the the United States can be made without provisions of this part shall be brought endangering the livestock or poultry of into the United States except in ac- the United States, and that Depart- cordance with the regulations in this 3 ment inspectors may inspect the horses part and part 94 of this subchapter; on board such means of conveyance or nor shall any such horse or product be in such holding facility to ascertain handled or moved after physical entry whether the requirements of this para- into the United States before final re- graph are met, and dispose of them in lease from quarantine or any other accordance with the Animal Health form of governmental detention except in compliance with such regulations; 4 Provided, That, the Administrator may Such permit may be obtained from the Animal and Plant Health Inspection Service, Veterinary Services, National Center for Im- 3 Importations of certain animals from var- port-Export, 4700 River Road Unit 38, River- ious regions are absolutely prohibited under dale, Maryland 20737–1231. part 94 because of specific diseases. 5 See footnote 4 to subpart C.

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Protection Act (7 U.S.C. 8301 et seq.) if www.aphis.usda.gov/importlexport/ani- such conditions are not met; and mals/animalldiseaselstatus.shtml. Cop- (2) The carrier or its agent executes ies of the list will also be available via and furnishes to the collector of Cus- postal mail, fax, or email upon request toms at the first port of arrival a dec- to the Sanitary Trade Issues Team, Na- laration stating that the horses will be tional Center for Import and Export, retained aboard such means of convey- Veterinary Services, Animal and Plant ance or in an approved holding facility Health Inspection Service, 4700 River during transshipment as required by Road Unit 38, Riverdale, Maryland this paragraph. 20737. (3) Provisions for the approval of fa- (ii) APHIS will add a region to the cilities required in this paragraph are: list upon determining that the disease (i) They must be sufficiently isolated exists in the region based on reports to prevent direct or indirect contact APHIS receives of outbreaks of the dis- with all other animals and birds while ease from veterinary officials of the ex- in the United States. porting country, from the World Orga- (ii) They must be so constructed that nization for Animal Health (OIE), or they provide adequate protection from other sources the Administrator against environmental conditions and determines to be reliable, or upon de- can be adequately cleaned, washed and termining that the region trades horses disinfected. freely with a region in which CEM ex- (iii) They must provide for disposal of ists without testing for CEM. APHIS horse carcasses, manure, bedding, will remove a region from the list after waste and any related shipping mate- conducting an evaluation of the region rials in a manner that will prevent dis- in accordance with § 92.2 of this sub- semination of disease. chapter and finding that the disease is (iv) They must have provisions for not present in the region. In the case of adequate sources of feed and water and a region formerly not on this list that for attendants for the care and feeding is added due to an outbreak, the region of horses in the facility. may be removed from the list in ac- (v) They must comply with addi- cordance with the procedures for rees- tional requirements as may be imposed tablishment of a region’s disease-free by the Administrator if deemed appli- status in § 92.4 of this subchapter. cable for a particular shipment. (2) Exceptions. The provisions of para- (vi) They must also comply with all graph (c)(1) of this section shall not applicable local, State and Federal reapply to the following: quirements for environmental quality and with the provisions of the Animal (i) Wild (non-domesticated) species of Welfare Regulations in chapter I of this equidae if captured in the wild or im- title, as applicable. ported from a zoo or other facility (c) Specific prohibitions regarding con- where it would be unlikely that the tagious equine metritis; exceptions—(1) animal would come in contact with do- Importation prohibited. Except as pro- mesticated horses used for breeding; vided in paragraph (c)(2) of this sec- (ii) Geldings; tion, notwithstanding the other provi- (iii) Weanlings or yearlings that have sions of this part concerning the im- never been used for breeding, and portation of horses into the United whose age and breeding status are cer- States, the importation of all horses tified on the import health certificate from any region that APHIS considers required under § 93.314(a); to be affected with contagious equine (iv) Horses imported in accordance metritis (CEM) and the importation of with conditions prescribed by the Ad- all horses that have been in any such ministrator as provided in § 93.301(a); region within the 12 months imme- (v) Spanish Pure Breed horses im- diately preceding their being offered ported for permanent entry from Spain for entry into the United States is pro- or thoroughbred horses imported for hibited. permanent entry from France, Ger- (i) A list of regions that APHIS con- many, Ireland, or the United Kingdom siders to be affected with CEM is main- if the horses meet the requirements of tained on the APHIS Web site at http:// paragraph (d) of this section;

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(vi) Stallions or mares over 731 days certified by the breed association to be of age imported for permanent entry if current, true, and factual for the fol- the horses meet the requirements of lowing information: paragraph (e) of this section; (1) Identification of the horse by (vii) Horses over 731 days of age im- name, sex, age, breed, and all identi- ported into the United States for no fying marks; more than 90 days to compete in speci- (2) Identification of all premises fied events if the horses meet the re- where the horse has been since reach- quirements of paragraph (f)(1) of this ing 731 days of age and the dates that section; the horse was at such premises; (viii) Horses over 731 days of age imported into the United States for non- (3) For thoroughbred horses, that competitive public exhibition and en- none of the premises where the horse tertainment purposes if the horses has been since reaching 731 days of age meet the requirements of paragraph are breeding premises; and (f)(2) of this section; and (4) For Spanish Pure Breed horses (ix) Horses temporarily exported from Spain, that since reaching 731 from the United States or from another days of age: region not known to be affected with (i) The horse has never been on a CEM to a region listed under paragraph premises that is exclusively a breeding (c)(1) of this section within the 12 premises; months immediately preceding their (ii) The horse has never been bred; being offered for entry into the United (iii) Breeding of the horse has never States if the horses meet the require- been attempted; and ments of paragraph (g) of this section. (iv) The horse has never been com- (d) Spanish Pure Breed horses from mingled and left unattended with adult Spain and thoroughbred horses from horses of the opposite sex; France, Germany, Ireland, and the United Kingdom. (1) Spanish Pure Breed horses (C) He or she has compared the from Spain and thoroughbred horses records maintained by the approved from France, Germany, Ireland, and breed association with the records kept the United Kingdom may be imported by the trainer and has found the infor- for permanent entry if the horses meet mation in those two sets of records to the following requirements: be consistent and current; (i) Each horse is accompanied at the (D) For Spanish Pure Breed horses time of importation by an import per- and thoroughbred horses over 731 days mit in accordance with § 93.304; of age, cultures negative for CEM were (ii) Each horse is accompanied at the obtained from three sets of specimens time of importation by an import collected within a 12-day period from health certificate issued in accordance the mucosal surfaces of the clitoral with § 93.314(a). In addition to the infor- fossa, distal cervix or endometrium, mation required by § 93.314(a), the vet- and the clitoral sinuses of any female erinarian signing and issuing the cer- horses and from the surfaces of the pre- tificate must certify that: puce, the urethral sinus, the distal ure- (A) He or she has examined the daily thra, and the fossa glandis, including records of the horse’s activities main- the diverticulum of the fossa glandis, tained by the trainer and certified to of any male horses. For both male and be current, true, and factual by the female horses, the sets of specimens veterinarian in charge of the training must be taken within a 12-day period or racing stable; with no less than 72 hours between (B) He or she has examined the each set, and the last of these sets of records of the horse’s activities main- specimens must be collected within 30 tained by a breed association specifi- days prior to exportation. All speci- cally approved by the Department 6 and mens required by this paragraph must be collected by a licensed veterinarian 6 The following breed associations and their record systems have been approved by the Department: Asociacion National de Kingdom and Ireland; Haras du Pain for Criadores de Caballos de Pura Raza Espanola France; and Direktorium fu¨ r Vollblutzucht for Spain; Weatherby’s Ltd. for the United und Rennen e.v. for Germany.

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who either is, or is acting in the pres- or mare will be consigned to a State ence of, the veterinarian signing the that the Administrator has approved to certificate; and receive such horses in accordance with (E) All specimens required by para- paragraph (h) of this section; graph (d)(1)(ii)(D) of this section were (ii) The horses are accompanied at received within 48 hours of collection the time of importation by an import by a laboratory approved to culture for health certificate issued in accordance CEM by the national veterinary service with § 93.314(a); of the region of export and were accom- (iii) A set of specimens must be col- panied by a statement indicating the lected from each horse within 30 days date and time of their collection. prior to the date of export by a licensed (2) If any specimen collected in ac- veterinarian who either is, or is acting cordance with paragraph (d)(1)(ii)(D) of in the presence of, the veterinarian this section is found to be positive for signing the certificate. For stallions, CEM, the horse must be treated for the specimens must be collected from CEM in a manner approved by the na- the prepuce, urethral sinus, distal ure- tional veterinary service of the region thra, and fossa glandis, including the of export. After the treatment is com- diverticulum of the fossa glandis; for pleted, at least 21 days must pass be- mares, the specimens must be collected fore the horse will be eligible to be from the mucosal surfaces of the clit- tested again in accordance with para- oral fossa and the clitoral sinuses. All graph (d)(1)(ii)(D) of this section. All of the specimens collected must be cul- treatments performed, and the dates of tured for CEM with negative results in the treatments, must be recorded on a laboratory approved to culture for the health certificate. CEM by the national veterinary service (3) Spanish Pure Breed horses and of the region of origin; thoroughbred horses imported under (iv) The horses described on the cer- paragraph (d)(1) of this section may be tificate must not have been used for released upon completion of the Fed- natural breeding, for the collection of eral quarantine required under § 93.308. semen for artificial insemination in Spanish Pure Breed horses and thor- the case of stallions, or for artificial oughbred horses found positive for insemination in the case of mares, CEM that have been treated and re- from the time the specimens were col- tested as provided in paragraph (d)(2) of lected through the date of export; this section shall, upon completion of (v) All specimens required by para- the Federal quarantine required under graph (e)(1)(iii) of this section must be § 93.308, be consigned to an approved received within 48 hours of collection State listed under paragraph (h)(6) or by a laboratory approved to culture for (h)(7) of this section, where they shall CEM by the national veterinary service be quarantined under State or Federal of the region of export and must be ac- supervision until the stallions have companied by a statement indicating met the testing and treatment require- the date and time of their collection; ments of paragraph (e)(3) of this sec- and tion and the mares have met the test- (vi) If any specimen collected in ac- ing and treatment requirements of cordance with paragraph (e)(1)(iii) of paragraph (e)(5) of this section. this section is found to be positive for (e) Stallions and mares over 731 days of CEM, the stallion or mare must be age from CEM-affected regions. (1) Stal- treated for CEM in a manner approved lions or mares over 731 days of age may by the national veterinary service of be imported for permanent entry from the region of export. After the treat- a region listed under paragraph (c)(1) of ment is completed, at least 21 days this section if the horses meet the fol- must pass before the horse will be eligi- lowing requirements: ble to be tested again in accordance (i) Each horse is accompanied at the with paragraph (e)(1)(ii) of this section. time of importation by an import per- All treatments performed, and the mit issued in accordance with § 93.304. dates of the treatments, must be re- The import permit must indicate that, corded on the health certificate. after completion of the Federal quar- (2) Post-entry. (i) Stallions and mares antine required in § 93.308, the stallion imported under paragraph (e)(1) of this

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section must complete the Federal and urethral sinus while the stallion is quarantine required under § 93.308. in full erection with a solution of not Upon completion of the Federal quar- less than 2 percent surgical scrub antine, stallions must be sent to an ap- chlorhexidine and then thoroughly proved State listed under paragraph coating (packing) the stallion’s pre- (h)(6) of this section, and mares must puce, penis, including the fossa glandis, be sent to an approved State listed and urethral sinus with an ointment ef- under paragraph (h)(7) of this section. fective against the CEM organism. 7 (ii) Once in the approved State, the The treatment shall be performed by stallions or mares shall be quarantined an accredited veterinarian and mon- under State or Federal supervision itored by a State or Federal veteri- until the stallions have met the testing narian. and treatment requirements of para- (B) Each mare to which the stallion graph (e)(3) of this section and the has been test bred shall be cultured for mares have met the testing and treat- CEM from three sets of specimens from ment requirements of paragraph (e)(5) the mucosal surfaces of the clitoral of this section. fossa, clitoral sinuses, and from either (iii) All tests and cultures required the distal cervix or endometrium be- by paragraphs (e)(3) through (e)(5) of tween the third and fourteenth day this section shall be conducted at the after breeding, with negative results. National Veterinary Services Labora- The sets of specimens must be col- tories, Ames, IA, or at a laboratory ap- lected on three separate occasions proved by the Administrator in accord- within a 12-day period with no less ance with paragraph (i) of this section than 72 hours between each set. A com- to conduct CEM cultures and tests. plement fixation test for CEM must be (iv) To be eligible for CEM culture or done with negative results on the twen- testing, all specimens collected in ac- ty-first day after the breeding. cordance with paragraphs (e)(3) (ii) If any culture or test required by through (e)(5) of this section must be this paragraph is positive for CEM, the received by the National Veterinary stallion shall be treated as described in Services Laboratories or the approved paragraph (e)(3)(i)(A) of this section laboratory within 48 hours of collection and retested by being test bred to two and must be accompanied by a state- mares no less than 21 days after the ment indicating the date and time of last day of treatment. their collection. (iii) A stallion may be released from (3) Testing and treatment requirements State quarantine only if all cultures for stallions. (i) Once the stallion is in and tests of specimens from the mares used for test breeding are negative for the approved State, three sets of speci- CEM and all cultures performed on mens consisting of one culture swab specimens taken from the stallion are from each location shall be taken from negative for CEM. the prepuce, the urethral sinus, the dis- (4) Requirements for test mares. (i) tal urethra, and the fossa glandis, in- Mares to be used to test stallions for cluding the diverticulum of the fossa CEM shall be permanently identified glandis, of the stallion and be cultured before the mares are used for such test- for CEM. The sets of specimens must be ing with the letter ‘‘T.’’ The marking collected on three separate occasions shall be permanently applied by an in- within a 12-day period with no less spector, a State inspector, or an ac- than 72 hours between each set. No credited veterinarian who shall use a sooner than after the second set of hot iron, freezemarking, or a lip tat- specimens is collected and cultured for too. If a hot iron or freezemarking is CEM with negative results, the stallion used, the marking shall not be less must be test bred to two test mares than 2 inches (5.08 cm) high and shall that meet the requirements of para- be applied to the left shoulder or left graph (e)(4) of this section. Upon completion of the test breeding: 7 A list of ointments effective against the (A) The stallion must be treated for 5 CEM organism may be obtained from the Na- consecutive days by thoroughly clean- tional Center for Import and Export, Import/ ing and washing (scrubbing) its pre- Export Animals, VS, APHIS, 4700 River Road puce, penis, including the fossa glandis, Unit 39, Riverdale, MD 20737–1231.

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side of the neck of the mare. If a lip ministrator in accordance with para- tattoo is used, the marking shall not graph (i) of this section to conduct be less than 1 inch (2.54 cm) high and CEM cultures and tests. 0.75 inch (1.9 cm) wide and shall be ap- (ii) After the three sets of specimens plied to the inside surface of the upper required by paragraph (e)(5)(i) of this lip of the test mare. section have been collected, an accred- (ii) The test mares must be qualified ited veterinarian shall manually re- prior to breeding as apparently free move organic debris from the sinuses of from CEM and may not be used for each mare and then flush the sinuses breeding from the time specimens are with a cerumalytic agent. 8 taken to qualify the mares as free from (iii) For 5 consecutive days after the CEM. To qualify, each mare shall be sinuses have been cleaned, an accred- tested with negative results by a com- ited veterinarian shall aseptically plement fixation test for CEM, and clean and wash (scrub) the external specimens taken from each mare shall genitalia and vaginal vestibule, includ- be cultured negative for CEM. For each ing the clitoral fossa, with a solution culture, sets of specimens shall be col- of not less than 2 percent chlorhexidine lected on three separate occasions from in a detergent base and then fill the the mucosal surfaces of the clitoral clitoral fossa and sinuses, and coat the fossa, clitoral sinuses, and from either external genitalia and vaginal vesti- the distal cervix or endometrium with- bule with an antibiotic ointment effec- in a 12-day period with no less than 72 tive against the CEM organism. 9 hours between each set. (iv) A mare may be released from (iii) A test mare that has been used State quarantine only if all cultures to test stallions for CEM may be re- performed on specimens taken from leased from quarantine only if: the mare are negative for CEM. (A) The test mare is found negative (v) If any culture required by this for CEM on all cultures and tests re- paragraph is positive for CEM, the quired under paragraph (e)(3)(ii) of this mare shall be treated as described in section; or paragraphs (e)(5)(ii) and (e)(5)(iii) of (B) The test mare is subjected to an this section. No less than 21 days after ovariectomy by an accredited veteri- the last day of treatment, the mare narian under the direct supervision of a shall be tested again in accordance State or Federal veterinarian; or with paragraph (e)(5)(i) of this section. (C) The test mare is treated and han- If all specimens are negative for CEM, dled in accordance with paragraph the mare may be released from quar- (e)(5) of this section; or antine. (D) The test mare is moved directly (f) Special provisions for temporary im- to slaughter without unloading en portation for competition or entertainment route, is euthanized, or dies. purposes. (1) Horses over 731 days of age (5) Testing and treatment requirements may be imported into the United for mares. (i) Once the mare is in the States for no more than 90 days to approved State, a complement fixation compete in specified events provided test for CEM must be done, and three that the conditions in paragraphs (f)(3) sets of specimens shall be collected through (f)(12) of this section are met. from the mucosal surfaces of the clit- (2) Horses over 731 days of age may be oral fossa and clitoral sinuses, with one temporarily imported into the United set of specimens including a specimen States solely for noncompetitive public from the surfaces of the distal cervix or exhibition and entertainment purposes endometrium in nonpregnant mares. The sets of specimens must be col- 8 Recommended protocols for the flushing lected on three separate occasions of sinuses may be obtained from the Na- within a 12-day period with no less tional Center for Import and Export, Import/ than 72 hours between each set. An ac- Export Animals, VS, APHIS, 4700 River Road credited veterinarian shall collect Unit 39, Riverdale, MD 20737–1231. 9 A list of ointments effective against the specimens and shall submit each set of CEM organism may be obtained from the Na- specimens to the National Veterinary tional Center for Import and Export, Import/ Services Laboratories in Ames, IA, or Export Animals, VS, APHIS, 4700 River Road to a laboratory approved by the Ad- Unit 39, Riverdale, MD 20737–1231.

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provided that the conditions in para- (A) Must not be entered in competi- graphs (f)(3) through (f)(12) of this sections. tion are met. (B) Must be regularly used in per- (3) At the time of importation, each formances or exhibitions, unless sick horse must be accompanied by an im- or injured. A horse that is no longer port permit in accordance with § 93.304 performing or being exhibited must be and a health certificate issued in ac- exported or made eligible for perma- cordance with § 93.314. For horses im- nent entry in accordance with para- ported in accordance with paragraph graph (f)(9) of this section. (f)(2) of this section, the health certifi- (C) Must be kept with the other cate must also certify that cultures horses listed on the import permit, un- negative for CEM were obtained from less otherwise approved by an APHIS three sets of specimens collected from representative. the mucosal surfaces of the clitoral (ii) Except as provided in paragraph fossa and clitoral sinuses, with one set (f)(5)(viii) of this section, the horse of specimens including a specimen must be moved according to the from the surfaces of the distal cervix or itinerary and methods of transport endometrium, of any female horses and specified in the import permit provided from the surfaces of the prepuce, the for in § 93.304. urethral sinus, the distal urethra, and (iii) The horse must be monitored by the fossa glandis, including the diver- an accredited veterinarian or APHIS ticulum of the fossa glandis, of any representative to ensure that the pro- male horses. For both female and male visions of paragraphs (f)(5)(ii), (f)(5)(vi), horses, the sets of specimens must be and (f)(5)(vii) of this section are met. If collected on three separate occasions the monitoring is performed by an ac- within a 12-day period with no less credited veterinarian, the Veterinarian than 72 hours between each set, and the in Charge will ensure that the accred- last of these sets of specimens must be ited veterinarian is familiar with the collected within 30 days prior to expor- requirements of this section and spot tation. All specimens required by this checks will be conducted by an APHIS paragraph must be collected by a li- representative to ensure that the re- censed veterinarian who either is, or is quirements of this section are being acting in the presence of, the veteri- met. If an APHIS representative finds narian signing the certificate. that requirements are not being met, (4) Following the horse’s arrival in the Administrator may require that all the United States: remaining monitoring be conducted by (i) A horse imported in accordance APHIS representatives to ensure com- with paragraph (f)(1) of this section pliance. may remain in the United States for (iv) Except when in transit, the horse not more than 90 days, except as pro- must be kept on a premises that has vided in paragraph (f)(9) of this section. been approved by an APHIS representa- (ii) A horse imported in accordance tive. For horses imported in accord- with paragraph (f)(2) of this section ance with paragraph (f)(1) of this sec- may remain in the United States in- tion, such approval may be oral or in definitely, except as provided in para- writing. If the approval is oral, it will graph (f)(9) of this section, as long as be confirmed in writing by the Admin- the conditions of paragraphs (f)(3) istrator as soon as circumstances per- through (f)(12) of this section are met mit. For horses imported in accordance and the horse’s owner or importer ap- with paragraph (f)(2) of this section, plies for and obtains from APHIS an the approval will be in writing. To re- import permit, as provided for in ceive approval, the premises: § 93.304, each year prior to the anniver- (A) Must not be a breeding premises; sary date of the horse’s arrival in the and United States. (B) Must be or contain a building or (5) While the horse is in the United temporary structure in which the horse States, the following conditions must can be kept in a stall that is separated be met: from other stalls that contain horses (i) A horse imported in accordance that are not listed on the import per- with paragraph (f)(2) of this section: mit, either by an empty stall, by an

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open area across which horses cannot risk to other horses in the United touch each other, or by a solid wall States. that is at least 8 feet (2.4 meters) high. (xi) The owner or importer of the (v) While in transit, the horse must horse must comply with any other probe moved in either an aircraft or a visions of this part applicable to him or sealed van or trailer. If the horse is her. moved in a sealed van or trailer, the (6) Except as provided in paragraph seal may be broken only by an APHIS (f)(7) of this section, if the owner or im- representative at the horse’s destina- porter wishes to change the horse’s tion, except in situations where the itinerary or the methods by which the horse’s life is in danger. horse is transported from that which (vi) Except when actually competing, he or she specified in the application performing, or being exhibited or exer- for the import permit, the owner or im- cised, the horse must be kept in a pas- porter must make the request for ture approved by APHIS or in a stall change in writing to the Adminis- that is separated from other stalls con- trator. Requests for change must be taining horses that are not listed on submitted to APHIS no less than 15 the import permit, either by an empty days before the proposed date of the stall, by an open area across which change. Requests may be submitted to horses cannot touch each other, or by a APHIS by postal mail, commercial de- solid wall that is at least 8 feet (2.4 me- livery service, fax, or e-mail. The ters) high. change in itinerary or method of trans- (vii) The horse may not be used for port may not be made without the breeding purposes (including artificial written approval of the Administrator, insemination or semen collection) and who may grant the request for change may not have any other sexual contact when he or she determines that grant- with other horses. The horse may not ing the request will not endanger other undergo any genital examinations, ex- horses in the United States and that cept that a horse imported in accord- sufficient APHIS personnel are avail- ance with paragraph (f)(2) of this sec- able to provide the services required by tion may undergo genital examinations the owner or importer. for diagnosis or treatment of a medical condition with the prior approval of an (7) In response to an emergency or APHIS representative. other unforeseen circumstances or (viii) The horse may be moved for di- events (e.g., weather-related transpor- agnosis or treatment of a medical con- tation delays, vehicle breakdown, med- dition with the prior approval of an ical emergencies, etc.), the horse’s APHIS representative. itinerary or methods of transportation (ix) After the horse is transported may be changed, with the prior ap- anywhere in the United States, any ve- proval of an APHIS representative, hicle in which the horse was trans- from that which is specified in the ap- ported must be cleaned and disinfected plication for an import permit. Re- in the presence of an APHIS represent- quests for such a change may be sub- ative, according to the procedures spec- mitted to APHIS by telephone, postal ified in §§ 71.7 through 71.12 of this mail, commercial delivery service, fax, chapter, before any other horse is or e-mail. Approval may be oral or in transported in the vehicle. writing. If the approval is oral, it will (x) The cleaning and disinfection be confirmed in writing by the Admin- specified in paragraph (f)(5)(ix) of this istrator as soon as circumstances per- section must be completed before the mit. vehicle is moved from the place where (8) The Administrator may cancel, the horse is unloaded. In those cases orally or in writing, the import permit where the facilities or equipment for provided for under § 93.304 whenever the cleaning and disinfection are inad- Administrator finds that the owner or equate at the place where the horse is importer of the horse has not complied unloaded, the Administrator may allow with the provisions of paragraphs (f)(3) the vehicle to be moved to another lo- through (f)(7) of this section or any cation for cleaning and disinfection conditions imposed under those provi- when the move will not pose a disease sions. If the cancellation is oral, the

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Administrator will confirm the can- do not permit the horse to be kept on cellation and the reasons for the can- those premises, or when the Adminis- cellation in writing as soon as cir- trator determines that keeping the cumstances permit. Any person whose horse on the above specified premises import permit is canceled may appeal will pose a disease risk to horses in the the decision in writing to the Adminis- United States, the horse must be kept, trator within 10 days after receiving at the expense of the owner or im- oral or written notification of the can- porter, on an alternative premises ap- cellation, whichever is earlier. If the proved by the Administrator. appeal is sent by mail, it must be post- (10) Stallions or mares over 731 days marked within 10 days after the owner of age that are imported in accordance or importer receives oral or written no- with paragraphs (f)(1) or (f)(2) of this tification of the cancellation, which- section may be eligible to remain in ever is earlier. The appeal must include the United States if the following is all of the facts and reasons upon which completed: the person relies to show that the im- (i) Following completion of the port permit was wrongfully canceled. itinerary specified in the import per- The Administrator will grant or deny mit provided for in § 93.304, the horse’s the appeal in writing as promptly as owner or importer applies for and re- circumstances permit, stating the rea- ceives a new import permit that speci- son for his or her decision. If there is a fies that the stallion or mare will be conflict as to any material fact, a hear- moved to an approved State listed ing will be held to resolve the conflict. under paragraph (h)(6) or (h)(7) of this Rules of practice concerning the hear- section; and ing will be adopted by the Adminis- (ii) The stallion or mare is trans- trator. ported in a sealed vehicle that has been (9) Except in those cases where an ap- cleaned and disinfected to an approved peal is in process, any person whose facility in an approved State where it import permit is canceled must move is quarantined under State or Federal the horse identified in the import per- supervision until the stallion or mare mit out of the United States within 10 has met the testing and treatment re- days after receiving oral or written no- quirements of paragraph (e)(3) or (e)(5) tification of cancellation, whichever is of this section. earlier. The horse is not permitted to (11) All costs and charges associated enter competition, perform, or be ex- with the supervision and maintenance hibited from the date the owner or im- of a horse imported under paragraphs porter receives the notice of cancella- (f)(1) or (f)(2) of this section will be tion until the horse is moved out of the borne by the horse’s owner or importer. United States or until resolution of an The costs associated with the super- appeal in favor of the owner or im- vision and maintenance of the horse by porter. Except when being exercised, an APHIS representative at his or her the horse must be kept, at the expense usual places of duty will be reimbursed of the owner or importer, in a stall on by the horse’s owner or importer the premises where the horse is located through user fees payable under part when the notice of cancellation is re- 130 of this chapter. ceived or, if the horse is in transit (12) In the event that an APHIS rep- when the notice of cancellation is re- resentative must be temporarily de- ceived, on the premises where it is next tailed from his or her usual place of scheduled to compete, perform, or be duty in connection with the super- exhibited according to the import pervision and maintenance of a horse im- mit. The stall in which the horse is ported under this paragraph (f), the kept must be separated from other owner or importer of the horse must stalls containing horses that are not execute a trust fund agreement with listed on the import permit, either by APHIS to reimburse all expenses (in- an empty stall, by an open area across cluding travel costs, salary, per diem which horses cannot touch each other, or subsistence, administrative ex- or by a solid wall that is at least 8 feet penses, and incidental expenses) in- (2.4 meters) high. In cases where the curred by the Department in connec- owners of the above specified premises tion with the temporary detail. Under

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the trust fund agreement, the horse’s the amount deposited will be insuffi- owner or importer must deposit with cient to cover the services APHIS is APHIS an amount equal to the esti- scheduled to provide during the re- mated cost, as determined by APHIS, mainder of the horse’s stay, APHIS for the APHIS representative to in- will issue to the horse’s owner or im- spect the premises at which the horse porter a bill to restore the deposited will compete, perform, or be exhibited; amount to a level sufficient to cover to conduct the monitoring required by the estimated cost to APHIS for the re- paragraph (f)(5)(iii) of this section; and mainder of the horse’s stay in the to supervise the cleaning and disinfec- United States. The horse’s owner or tion required by paragraph (f)(5)(ix) of importer must pay the amount billed this section. The estimated costs will within 14 days after receiving the bill. be based on the following factors: If the bill is not paid within 14 days (i) Number of hours needed for an APHIS representative to conduct the after its receipt, APHIS will cease to required inspection and monitoring; perform the services provided for in (ii) For services provided during reg- paragraph (f)(5) of this section until ular business hours (8 a.m. to 4:30 p.m., the bill is paid. The Administrator will Monday through Saturday, except holi- inform the owner or importer of the days), the average salary, per hour, for cessation of services orally or in writ- an APHIS representative; ing. If the notice of cessation is oral, (iii) For services provided outside the Administrator will confirm, in regular business hours, the applicable writing, the notice of cessation and the rate for overtime, night differential, or reason for the cessation of services as Sunday or holiday pay, based on the soon as circumstances permit. In such average salary, per hour, for an APHIS a case, the horse must be kept, at the representative; expense of the owner or importer and (iv) Number of miles from the prem- until the bill is paid, in a stall either ises at which the horse competes, per- on the premises at which the horse is forms, or is exhibited to the APHIS of- located when the notice of cessation of fice or facility that is monitoring the services is received or, if the horse is in activities; transit when the notice of cessation of (v) Government rate per mile for services is received, on the premises at automobile travel or, if appropriate, which it is next scheduled to compete, cost of other means of transportation perform, or be exhibited according to between the premises at which the the import permit. The stall in which horse competes, performs, or is exhib- the horse is kept must be separated ited and the APHIS office or facility; from other stalls containing horses (vi) Number of trips between the that are not listed on the import per- premises at which the horse competes, mit, either by an empty stall, by an performs, or is exhibited and the open area across which horses cannot APHIS office or facility that APHIS touch each other, or by a solid wall representatives are required to make in that is at least 8 feet (2.4 meters) high. order to conduct the required inspec- In cases where the owners of the prem- tion and monitoring; (vii) Number of days the APHIS rep- ises where the horse would be kept fol- resentative conducting the inspection lowing a cessation of services do not and monitoring must be in ‘‘travel sta- permit the horse to be kept on those tus’’; premises, or when the Administrator (viii) Applicable Government per determines that keeping the horse on diem rate; and the premises will pose a disease risk to (ix) Cost of related administrative other horses in the United States, the support services. horse must be kept, at the expense of (13) If a trust fund agreement with the owner or importer, on an alter- APHIS has been executed by the owner native premises approved by the Ad- or importer of a horse in accordance ministrator. Until the bill is paid, the with paragraph (f)(12) of this section horse is not permitted to enter com- and APHIS determines, during the petition, perform, or be exhibited. Any horse’s stay in the United States, that amount deposited in excess of the costs

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to APHIS to provide the required serv- cordance with the export regulations in ices will be refunded to the horse’s part 91 of this chapter; owner or importer. (4) The horse must be examined by an (g) Special provisions for the importa- inspector at the U.S. port of entry and tion of horses that have been temporarily found by the inspector to be the iden- exported to a CEM-affected region. If a tical horse covered by the documents horse has been temporarily exported required by paragraphs (a) through (c) for not more than 60 days from the of this section and found by the inspec- United States to a CEM-affected region tor to be free of communicable disease listed under paragraph (c)(1) of this and exposure thereto; and section, or if a horse has been tempo- (5) The horse must be quarantined rarily exported for not more than 60 and tested at the U.S. port of entry as days from another region not known to provided in § 93.308 of this part prior to be affected with CEM to a CEM-af- release. fected region during the 12 months pre- (h) Approval of States. In order for a ceding its exportation to the United State to be approved to receive stal- States, the horse may be eligible for re- lions or mares over 731 days of age turn or importation into the United from a CEM-affected region listed States without meeting the require- under paragraph (c)(1) of this section ments of paragraphs (d) through (f) of that are imported under paragraph (e) this section under the following condi- of this section, the State must meet tions: the following conditions: (1) The horse must be accompanied (1) The State must enter into a writ- by a certificate that meets the require- ten agreement with the Administrator, ments of § 93.314(a) of this part issued whereby the State agrees to enforce its by each CEM-affected region that the laws and regulations to control CEM horse has visited during the term of its and to abide by the conditions of approval established by the regulations temporary exportation, and each cer- in this part. tificate must contain the following ad- (2) The State must agree to quar- ditional declarations: antine all stallions and mares over 731 (i) That the horse was held separate days of age imported under the provi- and apart from all other horses except sions of paragraph (e) of this section for the time it was actually partici- until the stallions have been treated in pating in an event or was being exer- accordance with paragraph (e)(3) of this cised by its trainer; section and the mares have been treat- (ii) That the premises on which the ed in accordance with paragraph (e)(5) horse was held were not used for any of this section. equine breeding purpose; (3) The State must agree to quar- (iii) That the horse was not bred to antine all mares used to test stallions or bred by any animal, nor did it have for CEM until the mares have been re- any other sexual contact or genital ex- leased from quarantine in accordance amination while in such region; and with paragraph (e)(4) of this section. (iv) That all transport while in such (4) The State must have laws or regu- region was carried out in cleaned and lations requiring that stallions over 731 disinfected vehicles in which no other days of age imported under paragraph horses were transported since such (e) of this section be treated in the cleaning and disinfection; manner specified in paragraph (e)(3) of (2) The horse is accompanied by an this section, and that mares over 731 import permit issued in accordance days of age imported under paragraph with § 93.304 of this part at the time of (e) of this section be treated in the exportation; manner specified in paragraph (e)(5) of (3) If the horse was temporarily ex- this section. ported from the United States and is (5) Approval of any State to receive being returned to the United States, stallions or mares imported from re- the horse must be accompanied by a gions affected with CEM may be sus- copy of the United States health cer- pended by the Administrator upon his tificate issued for its exportation from or her determination that any require- the United States and endorsed in ac- ments of this section are not being

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met. After such action is taken, the (B) A minimum of 2 years experience animal health authorities of the ap- working in a bacteriology laboratory; proved State will be informed of the and reasons for the action and afforded an (C) Experience working with the CEM opportunity to present their views organism, including knowledge of the thereon before such suspension is final- specific media requirements, atmos- ized; however, such suspension of ap- pheric requirements, and procedures proval shall continue in effect unless for the isolation and identification of 10 otherwise ordered by the Adminis- the CEM organism. trator. In those instances where there (ii) Follows standard test protocols that will reliably and consistently pro- is a conflict as to the facts, a hearing vide for the isolation and identification shall be held to resolve such conflict. of the CEM organism; 11 and (6) A list of States approved by (iii) Reports all official test results APHIS to receive stallions over 731 to the State animal health official and days of age imported under paragraph the Veterinarian in Charge. (e) of this section is maintained on the (2) To retain approval, the laboratory APHIS Web site at http:// must meet the requirements prescribed www.aphis.usda.gov/importlexport/ani- in paragraph (i)(1) of this section, and mals/downloads/ shall test with the CEM organism each stateslapplconductlcemltesting.pdf. lot of media it prepares to ensure that Copies of the list will also be available the media will support growth of the via postal mail, fax, or email upon re- laboratory’s reference culture. Media quest to the Sanitary Trade Issues that will not support growth of the ref- Team, National Center for Import and erence culture must be discarded. Export, Veterinary Services, Animal (3) The Administrator may deny or and Plant Health Inspection Service, withdraw approval of any laboratory to 4700 River Road Unit 38, Riverdale, conduct CEM culturing or testing upon Maryland 20737. a determination that the laboratory (7) A list of States approved by does not meet the criteria for approval APHIS to receive mares over 731 days or maintenance of approval under para- of age imported under paragraph (e) of graphs (i)(1) and (i)(2) of this section. this section is maintained on the (i) In the case of a denial of approval, APHIS Web site at http:// the operator of the laboratory will be informed of the reasons for denial and, www.aphis.usda.gov/importlexport/ani- upon request, will be afforded an oppor- mals/downloads/ tunity for a hearing with respect to the states app conduct cem testing.pdf. l l l l merits or validity of the denial in ac- Copies of the list will also be available cordance with rules of practice that via postal mail, fax, or email upon re- will be adopted for the hearing. quest to the Sanitary Trade Issues (ii) In the case of a withdrawal of ap- Team, National Center for Import and proval, before such action is taken, the Export, Veterinary Services, Animal operator of the laboratory will be in- and Plant Health Inspection Service, formed of the reasons for the proposed 4700 River Road Unit 38, Riverdale, withdrawal and, upon request, will be Maryland 20737. afforded an opportunity for a hearing (i) Approval of laboratories. (1) The Ad- with respect to the merits or validity ministrator will approve a laboratory of the proposed withdrawal in accord- to conduct CEM cultures and tests only ance with rules of practice that will be after consulting with the State animal adopted for the hearing. However, the health official in the State in which the laboratory is located and after de- 10 When training regarding CEM culturing termining that the laboratory: and testing is necessary, it may be obtained (i) Has technical personnel assigned at the National Veterinary Services Labora- to conduct the CEM culturing and test- tories, Ames, IA 50010. 11 ing who possess the following min- Standard test protocols recommended by the National Veterinary Services Labora- imum qualifications: tories and a list of approved laboratories can (A) A bachelor’s degree in microbi- be obtained from the National Veterinary ology; Services Laboratories, Ames, IA 50010.

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withdrawal will become effective pend- a region formerly not on this list that ing a final determination in the hear- is added due to a detection, the region ing when the Administrator determines may be removed from the list in ac- that such action is necessary to pro- cordance with the procedures for rees- tect the public health, interest, or safe- tablishment of a region’s disease-free ty. The withdrawal will be effective status in § 92.4 of this subchapter. upon oral or written notification, (1) A veterinarian must treat horses whichever is earlier, to the operator of with ivermectin 3 to 5 days prior to the the laboratory. In the event of oral no- date of export to the United States ac- tification, written confirmation will be cording to the recommended dose pre- given as promptly as circumstances scribed on the product’s label. allow. The withdrawal will continue in (2) Horses must be examined for effect pending completion of the hear- screwworm by a full-time salaried vet- ing and any judicial review of the hear- erinary official of the exporting coun- ing, unless otherwise ordered by the try within 24 hours prior to shipment Administrator. to the United States. The official must (iii) Approval for a laboratory to con- fully examine the horses, including duct CEM culturing or testing will be their external genitalia. If horses are automatically withdrawn by the Ad- found to be infested with screwworm, ministrator when the operator of the they must be treated until free from approved laboratory notifies the Na- infestation. tional Veterinary Services Labora- (3) At the time horses are loaded onto tories, Ames, IA 50010, in writing, that a means of conveyance for export, a the laboratory no longer conducts CEM veterinarian must treat any visible culturing and testing. wounds on the animals with a solution (j) Examination and treatment for of coumaphos dust at a concentration screwworm. Horses from regions where of 5 percent active ingredient. APHIS considers screwworm to exist (4) Horses must be accompanied to may be imported into the United the United States by a certificate States only if they meet the require- signed by a full-time salaried veteri- ments in paragraphs (j)(1) through (7) nary official of the exporting country. of this section and all other applicable The certificate must state that the requirements of this part. APHIS will horses, including their external geni- maintain a list of regions where talia, have been thoroughly examined screwworm is considered to exist on and found free of screwworm and that the APHIS Web site at http:// the horses have been treated in accord- www.aphis.usda.gov/importlexport/ani- ance with paragraphs (j)(1) and (j)(3) of mals/animalldiseaselstatus.shtml. Cop- this section. ies of the list will also be available via (5) Horses must be quarantined upon postal mail, fax, or email upon request arrival in the United States at an to the Sanitary Trade Issues Team, Na- APHIS animal import center for at tional Center for Import and Export, least 7 days. Veterinary Services, Animal and Plant (6) Horses must be examined for Health Inspection Service, 4700 River screwworm by a veterinarian within 24 Road Unit 38, Riverdale, Maryland hours after arrival at an APHIS animal 20737. APHIS will add a region to the import center in the United States. list upon determining that screwworm The examining veterinarian must ex- exists in the region based on reports amine horses, including their external APHIS receives of detections of the genitalia, to determine whether the pest from veterinary officials of the ex- horse is infested with screwworm. porting country, from the World Orga- (7) Horses must be held at the animal nization for Animal Health (OIE), or import center for a minimum of 7 days. from other sources the Administrator On day 7, prior to the horses’ release, determines to be reliable. APHIS will the horses must be examined by a vet- remove a region from the list after con- erinarian at the expense of the owner ducting an evaluation of the region in or broker. For this examination, male accordance with § 92.2 of this sub- horses must be tranquilized or sedated chapter and finding that screwworm is so that the external genitalia of the not present in the region. In the case of horses can be thoroughly examined. If

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screwworm is found during this exam- (c) Cleaning and disinfection: When- ination, the horses must be held in ever, upon inspection under this sec- quarantine and treated until free of in- tion, an inspector determines that a festation. means of conveyance or shipping container is contaminated with material (Approved by the Office of Management and Budget under control numbers 0579–0040, of animal origin so as to present a dan- 0579–0165, and 0579–0324) ger of the spread of any communicable animal disease, he or she shall notify [55 FR 31495, Aug. 2, 1990. Redesignated and the principal operator of the means of amended at 62 FR 56012, 56016, Oct. 28, 1997] conveyance or his or her agent in EDITORIAL NOTE: For FEDERAL REGISTER ci- charge, of such determination and the tations affecting § 93.301, see the List of CFR requirements under this section. The Sections Affected, which appears in the person so notified shall cause the Finding Aids section of the printed volume and at www.fdsys.gov. cleaning and disinfection of such means of conveyance and container § 93.302 Inspection of certain aircraft under the immediate supervision of, and other means of conveyance and and in the time and manner prescribed shipping containers thereon; un- by, the inspector. loading, cleaning, and disinfection (d) For purposes of this section, the requirements. term ‘‘shipping container’’ means any (a) Inspection: All aircraft and other container of a type specially adapted means of conveyance (including ship- for use in transporting any article on ping containers thereon) moving into the means of conveyance involved. the United States from any foreign re- [55 FR 31495, Aug. 2, 1990. Redesignated and gion are subject to inspection without amended at 62 FR 56012, 56016, Oct. 28, 1997; 68 a warrant by properly identified and FR 6344, Feb. 7, 2003] designated inspectors to determine whether they are carrying any animal, § 93.303 Ports designated for the im- carcass, product or article regulated or portation of horses. subject to disposal under any law or (a) Air and ocean ports. The following regulation administered by the Sec- ports have APHIS inspection and quar- retary of Agriculture for prevention of antine facilities necessary for quar- the introduction or dissemination of antine stations and all horses shall be any communicable animal disease. entered into the United States through (b) Unloading requirements: Whenever these stations, except as provided in in the course of any such inspection at paragraphs (b), (c), (d), (e), and (f) of any port in the United States the in- this section, §§ 93.308(a), (b) and (c) and spector has reason to believe that the 93.317: Los Angeles, California; Miami, means of conveyance or container is Florida; and Newburgh, New York. contaminated with material of animal (b) Canadian border ports. (1) The fol- (including poultry) origin, such as, but lowing land border ports are designated not limited to, meat, organs, glands, as having the necessary inspection fa- extracts, secretions, fat, bones, blood, cilities for the entry of horses from lymph, urine, or manure, so as to Canada: Eastport, Idaho; Houlton and present a danger of the spread of any Jackman, Maine; Detroit, Port Huron, communicable animal disease, the in- and Sault Ste. Marie, Michigan; spector may require the unloading of Baudette, Minnesota; Opheim, Ray- the means of conveyance and the mond, and Sweetgrass, Montana; Alex- emptying of the container if he or she andria Bay, Buffalo, and Champlain, deems it necessary to enable him or New York; Dunseith, Pembina, and her to determine whether the means of Portal, North Dakota; Derby Line and conveyance or container is in fact so Highgate Springs, Vermont; Oroville contaminated. The principal operator and Sumas, Washington. of the means of conveyance and his or (2) International Falls, Minnesota, is her agent in charge of the means of designated as a port of entry for horses conveyance shall comply with any such from Canada. requirement under the immediate su- (c) Mexican border ports. The fol- pervision of, and in the time and man- lowing land border ports are designated ner prescribed by, the inspector. for the entry of horses from Mexico:

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Brownsville, Hidalgo, Laredo, Eagle Finding Aids section of the printed volume Pass, Del Rio, Presidio, and El Paso, and at www.fdsys.gov. Texas; Douglas, Naco, Nogales, Sasabe, and San Luis, Arizona; Calexico and § 93.304 Import permits for horses San Ysidro, California; and Antelope from regions affected with CEM Wells, Columbus, and Santa Teresa, and for horse specimens for diagnostic purposes; reservation fees New Mexico. for space at quarantine facilities (d) Limited ports. The following ports maintained by APHIS. are designated as having inspection facilities for the entry of horses and (a) Application for permit; reservation horse products such as horse test speci- required. (1)(i) For horses from regions mens which do not appear to require listed in § 93.301(c)(1) of the regulations, restraint and holding inspection facili- horses intended for quarantine at a pri- ties: Anchorage and Fairbanks, Alaska; vately owned quarantine facility, and San Diego, California; Jacksonville, St. horse test specimens for diagnostic Petersburg-Clearwater, and Tampa, screening purposes, intended for impor- Florida; Atlanta, Georgia; Honolulu, tation from any part of the world, ex- Hawaii; Chicago, Illinois; New Orleans, cept as otherwise provided for in Louisiana; Portland, Maine; Baltimore, §§ 93.315, 93.319, and 93.321, the importer Maryland; Boston, Massachusetts; Min- shall first apply for and obtain from neapolis, Minnesota; Great Falls, Mon- APHIS an import permit. The applica- tana; Dayton, Ohio; Portland, Oregon; tion shall specify the name and address San Juan, Puerto Rico; Memphis, Ten- of the importer; the species, breed, nessee (no live animals); Galveston and number or quantity of horses or horse Houston, Texas; and Seattle, Spokane, test specimens to be imported; the pur- and Tacoma, Washington. pose of the importation; individual (e) Ports for horses to be quarantined at horse identification which includes a privately owned quarantine facilities. description of the horse, name, age, Horses, except horses from or which markings, if any, registration number, have transited any region in which Af- if any, and tattoo or eartag; the region rican horsesickness is declared to of origin; the name and address of the exist, 12 may be entered into the United exporter; the port of embarkation in States at any port specified in para- the foreign region; the mode of trans- graph (a) of this section, or at any portation, route of travel, and the port other port designated as an inter- of entry in the United States; the pro- national port or airport by the U.S. posed date of arrival of the horses or Customs Service and quarantined at horse test specimens to be imported; privately owned quarantine facilities and the name of the person to whom provided that applicable provisions of the horses or horse test specimens will §§ 93.301(c), 93.304(a), 93.306, 93.308(a), (b) be delivered and the location of the and (c), and 93.314 are met. place in the United States to which de- (f) Designation of other ports. The Sec- livery will be made from the port of retary of the Treasury has approved entry. Additional information may be the designation as quarantine stations required in the form of certificates of the ports specified in this section. In concerning specific diseases to which special cases other ports may be des- the horses are susceptible, as well as ignated as quarantine stations under vaccinations or other precautionary this section by the Administrator, with treatments to which the horses or the concurrence of the Secretary of the horse test specimens have been sub- Treasury. jected. Notice of any such require- [55 FR 31495, Aug. 2, 1990. Redesignated at 62 ments will be given to the applicant in FR 56012, Oct. 28, 1997] each case. EDITORIAL NOTE: For FEDERAL REGISTER ci- (ii) Horses intended for importation tations affecting § 93.303, see the List of CFR under § 93.301(f)(1) of this part must Sections Affected, which appears in the meet the permit requirements of paragraph (a)(1)(i) of this section. Addition- 12 Information as to the regions where Afri- ally, for horses intended for importa- can horsesickness is declared to exist may be tion under § 93.301(f)(1) of this part, the obtained from the Administrator. horse’s owner or importer must include

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the following information with the ap- (I) A written plan for handling sick plication for permit that is required by or injured horses that includes: paragraph (a)(1)(i) of this section: (1) The name, address, and phone (A) That the application is being number of each accredited veterinarian made for a horse that will remain in who will provide veterinary services in the United States for no more than 90 the United States; days; (2) The name, address, and phone (B) The names, dates, and locations number of medical facilities to be used of the events in which the horse will to diagnose or treat sick or injured compete while in the United States; horses while in the United States; and (C) The names and locations of the (3) A plan to return sick or injured premises on which the horse will be horses to performance condition. kept while in the United States, and (J) An application for a trust fund or the dates the horse will be kept on escrow account agreement with APHIS each premises; and in accordance with § 93.301(f)(12). (D) The methods and routes by which (iv) Approval of an application for a the horse will be transported while in permit to import a horse under the United States. § 93.301(f) of this part is contingent (iii) Horses intended for importation upon a determination by the Adminis- under § 93.301(f)(2) must meet the per- trator that sufficient APHIS personnel mit requirements of paragraph (a)(1)(i) are available to provide the services re- of this section. Additionally, for horses quired. If more than one application for intended for importation under an import permit is received, APHIS § 93.301(f)(2), the horse’s owner or im- personnel will be assigned in the order porter must include the following in- that applications that otherwise meet formation with the application for per- the requirements of this section are remit that is required by paragraph ceived. (a)(1)(i) of this section: (2) An application for permit to import horses from regions listed in (A) The individual identifying infor- § 93.301(c)(1) or horses intended for mation required in paragraph (a)(1)(i) quarantine at a privately owned quar- of this section for all horses to be im- antine facility, may also be denied be- ported. cause of: Communicable disease condi- (B) The permanent electronic identi- tions in the area or region of origin, or fication of each horse to be imported, if in a region where the shipment has applicable. In the event that a horse been or will be held or through which has permanent electronic identifica- the shipment has been or will be trans- tion, the horse must be accompanied ported; deficiencies in the regulatory by a compatible reader. programs for the control or eradication (C) Photographs (head and lateral of animal diseases and the unavail- views) that are sufficient to identify ability of veterinary services in the each horse on an electronic medium above mentioned regions; the import- approved by APHIS. er’s failure to provide satisfactory evi- (D) The proposed total length of stay dence concerning the origin, history, in the United States. and health status of the horses; the (E) A description of the shows or lack of satisfactory information nec- events in which the horse will perform essary to determine that the importa- while in the United States. tion will not be likely to transmit any (F) The names, dates, and locations communicable disease to livestock or of the venues in which the horse will poultry of the United States; or any perform while in the United States. other circumstances which the Admin- (G) The names and locations of the istrator believes require such denial to premises on which the horse will be prevent the dissemination of any com- kept while in the United States, and municable disease of livestock or poul- the dates the horse will be kept on try into the United States. each premises. (3)(i) The importer or importer’s (H) The methods and routes by which agent shall pay or ensure payment of a the horse will be transported while in reservation fee for each lot of horses to the United States. be quarantined in a facility maintained

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by USDA. For horses, the reservation ensured by a letter of credit, the De- fee shall be 100 percent of the cost of partment will draw against the letter providing care, feed, and handling dur- of credit unless payment for services ing quarantine, as estimated by the received by the importer or importer’s quarantine facility’s veterinarian in agent in connection with the quar- charge. antine is otherwise made at least 3 (ii) At the time the importer or the days prior to the expiration date of the importer’s agent requests a reservation letter of credit. of quarantine space, the importer or (iv) Any reservation fee shall be for- importer’s agent shall pay the reserva- feited if the importer or the importer’s tion fee by check or U.S. money order agent fails to present for entry, within or ensure payment of the reservation 24 hours following the designated time fee by an irrevocable letter of credit of arrival, the horse for which the res- from a commercial bank (the effective ervation was made: Except that a res- date on such letter of credit shall run ervation fee shall not be forfeited if the to 30 days after the date the horses are Administrator determines that serv- scheduled to be released from quar- ices, other than provided by carriers, antine); except that anyone who issues necessary for the importation of the a check to the Department for a res- horses within the required period are ervation fee which is returned because unavailable because of unforeseen cir- of insufficient funds shall be denied cumstances as determined by the Ad- any further request for reservation of a quarantine space until the outstanding ministrator (such as the closing of an amount is paid. airport due to inclement weather or (iii) Any reservation fee paid by the unavailability of the reserved space check or U.S. money order shall be ap- due to the extension of another quar- plied against the expenses incurred for antine). services received by the importer or (v) If the reservation fee was ensured importer’s agent in connection with by a letter of credit and the fee is to be the quarantine for which the reserva- forfeited under paragraph (a)(3)(iv) of tion was made. Any part of the reserva- this section, the Department will draw tion fee which remains unused after against the letter of credit unless the being applied against the expenses in- reservation fee is otherwise paid at curred for services received by the im- least 3 days prior to the expiration porter or the importer’s agent in con- date of the letter of credit. nection with the quarantine for which (vi) If a reservation is canceled, the the reservation was made, shall be re- importer or the importer’s agent will turned to the individual who paid the be charged a fee according to the fol- reservation fee. If the reservation fee is lowing schedule:

Cancellation date Fee

30 or more days before the scheduled reservation date ...... 25 percent of the reservation fee. 15–29 days before the scheduled reservation date ...... 50 percent of the reservation fee. Less than 15 days before the scheduled reservation date ...... 100 percent of the reservation fee.

(vii) If the reservation fee was en- and it shall also be the responsibility sured by a letter of credit, the Depart- of the importer to ensure that the shipment will draw the amount of the can- per presents the copy of the permit to cellation fee against the letter of cred- the carrier and makes the necessary it unless the cancellation fee is other- arrangements for the original permit wise paid at least 3 days prior to the to accompany the shipment to the expiration date of the letter of credit. specified U.S. port of entry for presen- (b) Permit. (1) When a permit is tation to the collector of customs. issued, the original and two copies will (2) Horses and horse test specimens be sent to the importer. It shall be the for which a permit is required under responsibility of the importer to for- paragraph (a) of this section will be re- ward the original permit and one copy ceived at the port of entry specified on to the shipper in the region of origin, the permit within the time prescribed

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in the permit, which shall not exceed 14 ered, and the location of the place to days from the first day that the permit which such delivery will be made. is effective. (3) Horses and horse test specimens § 93.306 Inspection at the port of for which a permit is required under entry. paragraph (a) of this section will not be Inspection shall be made at the port eligible for entry if: of entry of all horses imported from (i) A permit has not been issued for any part of the world except as pro- the importation of the horse or horse vided in §§ 93.318 and 93.323. All horses test specimen; found to be free from communicable (ii) If the horse or horse test speci- disease and not to have been exposed men is unaccompanied by the permit thereto within 60 days prior to their issued for its importation; exportation to the United States shall (iii) If the horse or horse test speci- be admitted subject to the other provi- men is shipped from any port other sions in this part; all other horses shall than the one designated in the permit; be refused entry. Horses refused entry, unless exported within a time fixed in (iv) If the horse or horse test speci- each case by the Administrator of Vet- men arrives in the United States at erinary Service, and in accordance any port other than the one designated with other provisions he or she may rein the permit; quire in each case for their handling (v) If the horse or horse test speci- shall be disposed of as the Adminis- men offered for entry differs from that trator may direct. Such portions of the described in the permit; or transporting vessel, and of its cargo, (vi) If the horse or horse test speci- which have been exposed to any such men is not handled as outlined in the horses or their emanations shall be dis- application for the permit and as speci- infected in such manner as may be con- fied in the permit issued. sidered necessary by the inspector in (Approved by the Office of Management and charge at the port of entry, to prevent Budget under control numbers 0579–0040 and the introduction or spread of livestock 0579–0324) or poultry disease, before the cargo is [55 FR 31495, Aug. 2, 1990. Redesignated at 62 allowed to land. FR 56012, Oct. 28, 1997] [55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56016, Oct. 28, 1997; 68 EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 93.304, see the List of CFR FR 6344, Feb. 7, 2003] Sections Affected, which appears in the Finding Aids section of the printed volume § 93.307 Articles accompanying horses. and at www.fdsys.gov. No litter or manure, fodder or other aliment, nor any equipment such as § 93.305 Declaration and other docu- boxes, buckets, ropes, chains, blankets, ments for horses. or other things used for or about horses (a) The certificates, declarations, and governed by the regulations this part, affidavits required by the regulations shall be landed from any conveyance in this part shall be presented by the except under such restrictions as the importer or his or her agent to the col- inspector in charge at the port of entry lector of customs at the port of entry, shall direct. upon arrival of horses at such port, for the use of the veterinary inspector at § 93.308 Quarantine requirements. the port of entry. (a) Except as provided in this section (b) For all horses offered for importa- and in § 93.324, horses intended for im- tion, the importer or his or her agent portation into the United States from shall first present two copies of a dec- any part of the world shall be shipped laration which shall list the port of directly to a port designated in §§ 93.303 entry, the name and address of the im- and 92.324 and be quarantined at said porter, the name and address of the port until negative results to port of broker, the origin of the horses, the entry tests are obtained and the horses number, breed, species, and purpose of are certified by the port veterinarian the importation, the name of the per- to be free from clinical evidence of dis- son to whom the horses will be deliv- ease.

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(1) Except as provided in §§ 93.317 and for at least 60 days. This restriction 93.324 and in paragraph (a)(1)(i) of this also applies to horses that have section, horses intended for importa- stopped in or transited a region consid- tion from the Western Hemisphere ered affected with African horse sick- shall be quarantined at a port des- ness. ignated in § 93.303 for not less than 7 (i) A list of regions that APHIS con- days to be evaluated for signs of Ven- siders affected with African horse sick- ezuelan equine encephalomyelitis. ness is maintained on the APHIS Web (i) Horses imported from regions of site at http://www.aphis.usda.gov/ the Western Hemisphere that APHIS importlexport/animals/ considers to be free of Venezuelan animalldiseaselstatus.shtml. Copies of equine encephalomyelitis are exempt the list will also be available via postal from the requirements of paragraph mail, fax, or email upon request to the (a)(1) of this section. A list of regions Sanitary Trade Issues Team, National that APHIS has declared free of Ven- Center for Import and Export, Veteri- ezuelan equine encephalomyelitis is nary Services, Animal and Plant maintained on the APHIS Web site at Health Inspection Service, 4700 River http://www.aphis.usda.gov/importlexport/ Road Unit 38, Riverdale, Maryland animals/animallimport/equine/ 20737. equinelimportlquarantine.shtml. Copies (ii) APHIS will add a region to the of the list will also be available via list upon determining that the disease postal mail, fax, or email upon request exists in the region based on reports to the Sanitary Trade Issues Team, Na- APHIS receives of outbreaks of the dis- tional Center for Import and Export, ease from veterinary officials of the ex- Veterinary Services, Animal and Plant porting country, from the World Orga- Health Inspection Service, 4700 River nization for Animal Health (OIE), or Road Unit 38, Riverdale, Maryland from other sources the Administrator 20737. determines to be reliable. APHIS will (ii) APHIS will add a region to the remove a region from the list after con- list of those it has declared free of Ven- ducting an evaluation of the region in ezuelan equine encephalomyelitis after accordance with § 92.2 of this sub- it conducts an evaluation of the region chapter and finding that the disease is in accordance with § 92.2 of this sub- not present in the region. In the case of chapter and finds that the disease is a region formerly not on this list that not present. In the case of a region for- is added due to an outbreak, the region merly on this list that is removed due may be removed from the list in ac- to an outbreak, the region may be re- cordance with the procedures for rees- turned to the list in accordance with tablishment of a region’s disease-free the procedures for reestablishment of a status in § 92.4 of this subchapter. region’s disease-free status in § 92.4 of (3) To qualify for release from quar- this subchapter. APHIS will remove a antine, all horses, except horses from region from the list of those it has de- Iceland, must test negative to official clared free of Venezuelan equine tests for dourine, glanders, equine encephalomyelitis upon determining piroplasmosis, and equine infectious that the disease exists in the region anemia. 13 However, horses imported based on reports APHIS receives of outbreaks of the disease from veteri- 13 Because the official tests for dourine and nary officials of the exporting country, glanders are performed only at the National from the World Organization for Ani- Veterinary Services Laboratories in Ames, mal Health (OIE), or from other IA, the protocols for those tests have not sources the Administrator determines been published and are, therefore, not avail- to be reliable. able; however, copies of ‘‘Protocol for the (2) Horses intended for importation Complement-Fixation Test for Equine from regions APHIS considers to be af- Piroplasmosis’’ and ‘‘Protocol for the fected with African horse sickness may Immunno-Diffusion (Coggins) Test For Equine Infectious Anemia’’ may be obtained enter the United States only at the from the Animal and Plant Health Inspec- port of New York, and must be quar- tion Service, Veterinary Services, National antined at the New York Animal Im- Center for Import-Export, 4700 River Road port Center in Newburgh, New York, Unit 38, Riverdale, MD 20737–1231.

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from Australia and New Zealand are cilities must be submitted no less than exempt from testing for dourine and 15 days before the proposed date of glanders. In addition, all horses must entry of horses into the facility to undergo any other tests, inspections, APHIS, Veterinary Services, National disinfections, and precautionary treat- Center for Import and Export, 4700 ments that may be required by the Ad- River Road Unit 39, Riverdale, MD ministrator to determine their freedom 20737–1231. Before facility approval can from communicable diseases. be granted, a veterinary medical offi- (4) Any quarantine period required cer of APHIS must inspect the facility for a horse shall be counted using the to determine whether it complies with first day after arrival of the horse at the standards set forth in this section: the quarantine facility as the first day Provided, however, that approval of any of quarantine and may be extended for temporary facility and use of such fa- such additional period as the Adminis- cility will be contingent upon a deter- trator may require to determine its mination made by the Administrator freedom from disease. Any horse which that adequate personnel are available is positive to any of the port of entry to provide required services at the fa- tests named in this paragraph or any cility. Approval of any facility may be other test required by the Adminis- refused and approval of any quarantine trator, or which is found by the port facility may be withdrawn at any time veterinarian to exhibit evidence of by the Administrator, upon his or her communicable disease during quar- determination that any requirements antine shall be refused entry into the of this section are not being met. Be- United States and removed by the im- fore such action is taken, the operator porter to a country other than the of the facility will be informed of the United States within 10 days of the reasons for the proposed action by the date that the importer is notified by Administrator and afforded an oppor- APHIS that such horse has been re- tunity to present his or her views. If fused entry into the United States. there is a conflict as to any material Upon request, the Administrator may fact, a hearing will be held to resolve grant additional time for the removal the conflict. The cost of the facility of a horse from the United States in and all maintenance and operational any case in which he or she determines costs of the facility will be borne by that delay is unavoidable due to the operator. unforseen circumstances and the addi- (2) Standards and handling procedures. tional time for removal of the horse The facility must be maintained and will not present a threat of the spread operated in accordance with the fol- of communicable disease to other ani- lowing standards: mals in the United States. At the op- (i) Inspection. Inspection and quar- tion of the importer, such horse may be antine services must be arranged by disposed of in accordance with such the operator or his or her agent with conditions as the Administrator be- the APHIS Veterinarian in Charge for lieves necessary to prevent the dis- the State in which the approved facil- semination of communicable disease ity is located 14 no less than 7 days be- into the United States. The importer fore the proposed date of entry of the shall be responsible for all costs of such horses into the quarantine facility. removal or disposal. (ii) Physical plant requirements. (A) (b) Temporary, privately owned quar- The facility must be located and con- antine facilities. Horses presented for structed to prevent horses from having entry into the United States as pro- physical contact with animals outside vided in § 93.303(e) may be quarantined the facility. in temporary, privately owned quar- (B) The facility must be constructed antine facilities that meet the require- only with materials that can withstand ments of paragraphs (b)(1) and (b)(2) of this section and that have been ap- 14 The name and the address of the Veteri- proved by the Administrator for a spe- narian in Charge in any State is available cific importation. from APHIS, Veterinary Services, National (1) Approval. Requests for approval Center for Import and Export, 4700 River and plans for proposed temporary fa- Road Unit 39, Riverdale, MD 20737–1231.

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repeated cleaning and disinfection. Dis- an approved temporary facility must infectants authorized in 9 CFR part 71 be handled in accordance with para- must be used. All walls, floors, and graph (a) of this section while in quar- ceilings must be constructed of solid antine. material that is impervious to mois- (c) Permanent, privately owned quar- ture. Doors, windows, and other open- antine facilities. Horses presented for ings of the facility must be provided entry into the United States as pro- with double screens that will prevent vided in § 93.303(e) may be quarantined insects from entering the facility. in permanent, privately owned quar- (iii) Sanitation and security. (A) The antine facilities approved by the Ad- operator of the facility must arrange ministrator as meeting the require- for a supply of water adequate to clean ments of paragraphs (c)(1) through and disinfect the facility. (c)(6) of this section. (B) All feed and bedding must origi- (1) APHIS approval—(i) Approval pro- nate from an area not under quar- cedures. Persons seeking APHIS ap- antine because of splenetic or tick proval of a permanent, privately owned fever (see part 72 of this chapter) and quarantine facility must write to the must be stored within the facility. Administrator, c/o National Center for (C) Upon the death of any horse, the Import and Export, Veterinary Serv- operator must arrange for the disposal ices, APHIS, 4700 River Road Unit 39, of the horse’s carcass by incineration. Riverdale, MD 20737–1231. The applica- Disposal of all other waste removed tion letter must include the full name from the facility during the time the and mailing address of the applicant; horses are in quarantine or from horses the location and street address of the that are refused entry into the United facility for which approval is sought; States must be either by incineration blueprints of the facility; a description or in a public sewer system that meets of the financial resources available for all applicable environmental quality construction, operation, and mainte- control standards. Following comple- nance of the facility; the anticipated tion of the quarantine period and the source or origin of horses to be quar- release of the horses into the United antined, as well as the expected size States, all waste may be removed from the quarantine facility without further and frequency of shipments; a contin- restriction. gency plan for horses needing emer- (D) The facility must be maintained gency veterinary care; and a contin- and operated in accordance with any gency plan for the disposal of all the additional requirements the Adminis- horses capable of being housed in the trator deems appropriate to prevent facility. the dissemination of any commu- (A) If APHIS determines that an ap- nicable disease. plication is complete and merits fur- (E) The facility must comply with all ther consideration, the person applying applicable local, State, and Federal refor facility approval must enter into a quirements for environmental quality. service agreement with APHIS wherein (iv) Personnel. (A) Access to the facil- the applicant agrees to pay the cost of ity will be granted only to persons all APHIS services associated with working at the facility or to persons APHIS’ evaluation of the application specifically granted such access by an and facility. APHIS charges for the APHIS representative. evaluation of the application and facil- (B) The operator must provide at- ity at hourly rates listed in § 130.30 of tendants for the care and feeding of this chapter. This service agreement horses while in the quarantine facility. applies only to fees accrued during the (C) Persons working in the quar- application process. If the facility is antine facility may not come in con- approved by APHIS, facility owners tact with any horses outside the quar- must enter into a compliance agree- antine facility during the quarantine ment in accordance with paragraph period for any horses in the facility. (c)(2) of this section. (v) Handling of horses in quarantine. (B) Requests for approval must be Horses offered for importation into the submitted to APHIS at least 120 days United States that are quarantined in prior to the date of application for

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local building permits. Requests for ap- already in operation may be withdrawn proval will be evaluated on a first- at any time by the Administrator for come, first-served basis. any of the reasons provided in para- (ii) Criteria for approval. Before a fa- graph (c)(1)(iv)(C) of this section. cility may operate as a permanent, pri- (A) Before facility approval is denied vately owned quarantine facility for or withdrawn, the operator of the facil- horses, it must be approved by APHIS. ity will be informed of the reasons for To be approved: the proposed action by the Adminis- (A) The facility must meet all of the trator and afforded an opportunity to requirements of this section; present his or her views. If there is a (B) The facility must meet any addi- conflict as to any material fact, APHIS tional requirements that may be im- will afford the operator, upon request, posed by the Administrator in each the opportunity for a hearing with re- specific case, as specified in the com- spect to the merits or validity of such pliance agreement required under para- action. graph (c)(2) of this section, to ensure (B) The Administrator may withdraw that the quarantine of horses in the fa- approval of an existing facility prior to cility will be adequate to determine a final determination in the hearing if their health status, as well as to pre- the Administrator determines that vent the transmission of diseases into, such action is necessary to protect ani- within, and from the facility; and mal health or the public health, inter- (C) The Administrator must deter- est, or safety. Such withdrawal will be mine that sufficient personnel, includ- effective upon oral or written notifica- ing one or more APHIS veterinarians tion, whichever is earlier, to the oper- and other professional, technical, and ator of the facility. In the event of oral support personnel, are available to notification, APHIS will promptly give serve as APHIS representatives at the written confirmation to the operator of facility. If the facility is approved, the facility. This withdrawal will con- APHIS representatives will be present tinue in effect pending the completion at all import quarantine operations in of the hearing and any judicial review, order to monitor them and will be unless otherwise ordered by the Admin- present in order to provide other tech- istrator. In addition to withdrawal of nical services to ensure the biological approval for the reasons provided in security of the facility, including, but paragraph (c)(1)(iv)(C) of this section, not limited to, those specified in para- the Administrator will also automati- graph (c)(4)(v)(H) of § 93.308. The Ad- cally withdraw approval when the oper- ministrator’s determination will be ator of any approved facility notifies based on the expected size and fre- the APHIS Veterinarian in Charge for quency of shipments to the facility, as the State in which the facility is lo- described in the application for ap- cated, in writing, that the facility is no proval of a permanent facility, as well longer in operation.15 as any other pertinent information in (C) The Administrator may deny or the application. APHIS will assign per- withdraw approval of a permanent, pri- sonnel to facilities requesting approval vately owned facility if: in the order that the facilities are ap- (1) Any requirement of this section or proved. The Administrator has sole dis- the compliance agreement is not com- cretion on the number of APHIS per- plied with; or sonnel to be assigned to the facility. (2) The operator fails to remit any (iii) Maintaining approval. To main- charges for APHIS services rendered; tain APHIS approval, the operator or must continue to comply with all the (3) The operator or a person respon- requirements of paragraph (c) of this sibly connected with the business of section and the terms of the compli- the quarantine facility acts as a paid ance agreement executed in accordance with paragraph (c)(2) of this section. 15 The name and address of the Veteri- (iv) Denial or withdrawal of approval. narian in Charge in any State is available Approval for a proposed permanent, from APHIS, Veterinary Services, National privately owned quarantine facility Center for Import and Export, 4700 River may be denied or approval for a facility Road Unit 39, Riverdale, MD 20737–1231.

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agent (broker) for the importation or the hiring of employees and other per- subsequent sale of horses; or sonnel to attend to the horses as well (4) The operator or a person respon- as to maintain and operate the facility; sibly connected with the business of all costs associated with the care of the quarantine facility is or has been quarantined horses, such as feed, bed- found by a court of competent jurisdic- ding, medicines, inspections, testing, tion to have violated any law or regu- laboratory procedures, and necropsy lation pertaining to the importation or examinations; and all APHIS charges quarantine of any animal; or for the services of APHIS representa- (5) The operator or a person respon- tives in accordance with this section sibly connected with the business of and part 130 of this chapter; the quarantine facility is or has been (D) The operator agrees to bar from convicted of any crime involving fraud, the facility any employee or other per- bribery, or extortion or any other sonnel at the facility who fails to com- crime involving a lack of the integrity ply with paragraph (c) of this section needed for the conduct of operations af- or other provisions of this part, any fecting the importation of animals; or terms of the compliance agreement, or (6) The approved quarantine facility related instructions from APHIS rep- has not been in use to quarantine resentatives; horses for a period of at least 1 year. (E) The operator agrees to dem- (D) For the purposes of this section, onstrate, to the satisfaction of the Ad- a person is deemed to be responsibly ministrator, that the routine cleaning connected with the business of the and maintenance of the facility, the quarantine facility if such person has daily care of animals in quarantine, an ownership, mortgage, or lease inter- the disposal of wastes at the facility, est in the facility’s physical plant, or if the cleaning and disinfection proce- such person is a partner, officer, direc- dures employed by the facility, the tor, holder, or owner of 10 percent or handling, washing, and disposal of more of its voting stock, or is an em- soiled and contaminated clothing worn ployee in a managerial or executive ca- within the facility, and the disposal of pacity. dead horses, whether onsite or offsite, (v) Approval for existing facilities. Any adhere to the best practices of biologi- permanent, privately owned quarantine cal security and animal care; facility operating under APHIS author- (F) The operator agrees to random ization on August 3, 2009 must be ap- spot audits by APHIS representatives proved by APHIS to continue quar- to determine whether employees and antine operations by August 3, 2010 or other personnel are complying with else must cease horse quarantine oper- these practices; and ations. (G) The operator of the facility al- (2) Compliance agreement. (i) All per- lows the Administrator to amend the manent, privately owned quarantine compliance agreement at any time facilities for horses must operate in ac- after approval of the facility in order cordance with a compliance agreement to incorporate related instructions executed by the operator or his or her issued by APHIS representatives while agent and the Administrator, which the facility is operational must be renewed on an annual basis. (3) Physical plant requirements. The fa- (ii) The compliance agreement must cility must meet the following require- provide that: ments as determined by an APHIS in- (A) The facility must meet all appli- spection prior to admitting horses into cable requirements of this section; the facility: (B) The operator agrees to have (i) Location. The quarantine facility APHIS representatives present at all must be located in proximity to a port import quarantine operations at the fa- authorized under § 93.303(e). The site cility in order to monitor the import and the specific routes for the move- quarantine operations; ment of horses from the port to the (C) The operator agrees to be respon- site must be approved by the Adminis- sible for the cost of the facility; all trator based on consideration of wheth- costs associated with its maintenance er the site or routes would put the and operation; all costs associated with horses in a position that could result in

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the transmission of communicable dis- (E) Loading docks. The facility must eases to domestic horses. have separate docks for animal receiv- (ii) Construction. The facility must be ing and releasing and for general re- of sound construction, in good repair, ceiving and pickup, unless a single and properly designed to prevent the dock used for both purposes is cleaned escape of quarantined horses. It must and disinfected after each use in ac- have adequate capacity to receive and cordance with paragraph (c)(4)(iv)(F) of house shipments of horses as lots on an this section. ‘‘all in, all out’’ basis, whereby sepa- (F) Surfaces. The facility must be rate lots of horses can be received and constructed so that the floor surfaces housed without contact with any other with which horses have contact are lots being quarantined at the facility. nonslip and wear-resistant. All floor The facility must include the fol- surfaces with which the horses, their lowing: excrement, or discharges have contact (A) Perimeter fencing. The facility must provide for adequate drainage. must be surrounded by a security fence All floor and wall surfaces with which of sufficient height and design to pre- the horses, their excrement, or dis- vent the entry of unauthorized people charges have contact must be imper- and animals from outside the facility vious to moisture and be able to with- and to prevent the escape of the horses stand frequent cleaning and disinfec- in quarantine. tion without deterioration. Ceilings (B) Entrances and exits. All entryways and wall surfaces with which the into the nonquarantine area of the fa- horses, their excrement, or discharges cility must be equipped with a secure and lockable door. While horses are in do not have contact must be able to quarantine, all access to the quar- withstand cleaning and disinfection be- antine area for horses must be from tween shipments of horses. All floor within the building, and each such and wall surfaces must be free of sharp entryway to the quarantine area must edges that could cause injury to horses. be equipped with a series of solid self- (G) Horse stalls. The stalls in which closing double doors. Emergency exits horses are kept must be large enough to the outside are permitted in the to allow each animal to make normal quarantine area. Such emergency exits postural and social adjustments with must be constructed so as to permit adequate freedom of movement. Exer- their being opened from the inside of cise equipment for horses may be kept the facility only. in the stalls, provided that there will (C) Windows and other openings. The still be sufficient space within the facility must be constructed so that stalls for the horses to move freely any windows or other openings in the once the equipment is installed. quarantine area are double-screened (H) Aisleways. The aisleways through with screening of sufficient gauge and which horses are moved to and from mesh to prevent the entry or exit of in- stalls must be wide enough to provide sects and other vectors of diseases of for safe movement of horses, including horses and to provide ventilation suffi- allowing horses to turn around in the cient to ensure the comfort and safety aisleway, preventing horses in facing of all horses in the facility. The inte- stalls from coming into contact with rior and exterior screens must be sepa- horses in the aisleway, and adequately rated by at least 3 inches (7.62 cm). All ventilating the stalls. screening of windows or other openings (I) Means of isolation. Physical bar- must be easily removable for cleaning, riers must separate different lots of but must otherwise remain locked and horses in the facility so that horses in secure at all times in a manner satis- one lot cannot have physical contact factory to APHIS representatives in with horses in another lot or with their order to ensure the biological security of the facility. excrement or discharges. Stalls must be available that are capable of iso- (D) Lighting. The entire facility, including its stalls and hallways, must lating any horses exhibiting signs of have adequate lighting. illness.

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(J) Showers. A shower must be lo- operations. Storage space must include cated at each entrance to the quar- separate, secure storage for pesticides antine area. If the facility has a ne- and for medical and other biological cropsy area, a shower must be located supplies, as well as a separate vermin- at the entrance to the necropsy area. A proof storage area for feed and bedding, clothes-storage and clothes-changing if feed and bedding are stored at the fa- area must be provided with each show- cility. If the facility has multiple lot- er area. There must also be one or holding areas, then separate storage more receptacles near each shower so space for any reusable supplies and that clothing that has been worn into equipment that are not disinfected the quarantine area can be deposited in after each use in accordance with part a receptacle prior to entering the show- 71 of this chapter must be provided for er. each lot-holding area. (K) APHIS space. The facility must (N) Additional space needs. The facil- have adequate space for APHIS rep- ity must have an area for washing and resentatives to conduct examinations drying clothes, linens, and towels and and testing of the horses in quarantine, an area for cleaning and disinfecting prepare and package samples for mail- equipment used in the facility. The fa- ing, and store the necessary equipment cility must also include a work area for and supplies for duplicate samples. The the repair of equipment. space provided to conduct examina- (O) Restrooms. The facility must have tions and testing must include a refrig- permanent restrooms in both the quar- erator-freezer in which to store sam- antine and nonquarantine areas of the ples. The examination space must in- facility. clude equipment to provide for the safe (P) Ventilation and climate control. inspection of horses. The facility must The facility must be constructed with also include a secure, lockable office an air handling system capable of con- for APHIS use with enough room for a trolling and maintaining the ambient desk, chair, and filing cabinet. temperature, air quality, humidity, (L) Necropsy area. The facility must and odor at levels that are not inju- either include an area for conducting rious or harmful to the health of horses necropsies onsite or must have des- in quarantine. Air supplied to the quar- ignated an alternate facility at which a antine area must not be recirculated or suitable necropsy area is available. If reused for other ventilation needs. Air the facility has a necropsy area, it handling systems for lot-holding areas must be of sufficient size to perform must be separate from air handling necropsies on horses and be equipped systems for other operational and ad- with adequate lighting, hot and cold ministrative areas of the facility. In running water, a drain, a cabinet for addition, if the facility is equipped to storing instruments, a refrigerator- handle more than one lot of horses at a freezer for storing specimens, and an time, the air handling system must be autoclave to sterilize veterinary equip- adequate to ensure that there is no ment. If the facility does not have such cross-contamination of air between an area, it must specify an alternate separate lot-holding areas. facility at which a suitable necropsy (Q) Fire protection. The facility, in- area is available, a route from the cluding the lot-holding areas, must quarantine facility to the alternate fa- have a fire alarm voice communication cility’s necropsy area, and the safe- system. guards that will be in place to ensure (R) Communication system. The facil- that communicable diseases of horses ity must have a communication system are not spread during transit. This al- between the nonquarantine and quar- ternate facility and transport method- antine areas of the facility. ology must be approved by the Admin- (iii) Sanitation. To ensure that proper istrator under the procedures for re- animal health and biological security questing variances outlined in para- measures are observed, the facility graph (c)(6) of this section. must have the following: (M) Storage. The facility must have (A) Equipment and supplies nec- sufficient storage space for equipment essary to maintain the facility in clean and supplies used in import quarantine and sanitary condition, including pest

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control equipment and supplies and (I) The capability to control surface cleaning and disinfecting equipment drainage and effluent into, within, and with adequate capacity to disinfect the from the facility in a manner that pre- facility and equipment. vents the spread of disease into, with- (B) Any reusable equipment and sup- in, or from the facility. If the facility plies that are not disinfected after each is approved to handle more than one use in accordance with part 71 of this lot of horses at the same time, the chapter maintained separately for each drainage system must be adequate to lot of horses. ensure that there is no cross-contami- (C) Equipment and supplies used in nation between lot-holding areas. the quarantine area maintained sepa- (iv) Security. Facilities must provide rately from equipment and supplies the following security measures: used in the nonquarantine area. (A) The facility and premises must be (D) A supply of potable water ade- kept locked and secure at all times quate to meet all watering and clean- while horses are in quarantine. ing needs, with water faucets for hoses (B) The facility and premises must located throughout the facility. An have signs indicating that the facility emergency supply of water for horses is a quarantine area and no visitors are in quarantine must also be maintained. allowed. (E) A stock of disinfectant authorized (C) The facility and premises must be in part 71 of this chapter or otherwise guarded at all times by one or more approved by the Administrator that is representatives of a bonded security sufficient to disinfect the entire facil- company, or, alternatively, the facility ity. must have an electronic security sys- (F) The capability to dispose of tem that indicates the entry of unau- wastes, including manure, urine, and thorized persons into the facility. Elec- used bedding, by means of burial, incin- tronic security systems must be co- eration, or public sewer. Other waste ordinated through or with the local po- material must be handled in such a lice so that monitoring of the quar- manner that minimizes spoilage and antine facility is maintained whenever the attraction of pests and must be dis- APHIS representatives are not at the posed of by incineration, public sewer, facility. The electronic security sys- or other preapproved manner that pre- tem must be of the ‘‘silent type’’ and vents the spread of disease. Disposal of must be triggered to ring at the moni- wastes must be carried out in accord- toring site and not at the facility. The ance with the terms of the compliance electronic security system must be ap- agreement, and is subject to spot au- proved by Underwriter’s Laboratories. dits by APHIS representatives. The operator must provide written in- (G) The capability to dispose of horse structions to the monitoring agency carcasses in a manner approved by the stating that the police and a represent- Administrator and under conditions ative of APHIS designated by APHIS that minimize the risk of disease must be notified by the monitoring spread from carcasses. agency if the alarm is triggered. The (H) For incineration to be carried out operator must also submit a copy of at the facility, the facility must have those instructions to the Adminis- incineration equipment that is de- trator. The operator must notify the tached from other facility structures designated APHIS representative and is capable of burning animal waste whenever a breach of security occurs or and refuse. The incineration site must is suspected of having occurred. In the also include an area sufficient for solid event that disease is diagnosed in quar- waste holding. Incineration may also antined horses, the Administrator may take place at a local site away from require the operator to have the facil- the facility premises. All incineration ity guarded by a bonded security com- activities, whether onsite or offsite, pany in a manner that the Adminis- must be carried out in accordance with trator deems necessary to ensure the the terms of the compliance agree- biological security of the facility. ment, and are subject to spot audits by (D) The operator must furnish a tele- APHIS representatives. phone number or numbers to APHIS at

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which the operator or his or her agent who have access to the facility. The can be reached at all times. list must include the names, current (E) APHIS is authorized to place residential addresses, and employee APHIS seals on any or all entrances identification numbers of each person. and exits of the facility when deter- When the operator wishes to grant ac- mined necessary by APHIS and to take cess to the facility to persons who have all necessary steps to ensure that such not previously had access to it, the op- seals are broken only in the presence of erator must update the list prior to an APHIS representative. If someone such persons having access to the quar- other than an APHIS representative antine facility. breaks such seals, APHIS will consider (C) The operator must provide APHIS the act a breach in security and APHIS with signed statements from each em- representatives will make an imme- ployee and any other personnel hired diate accounting of all horses in the fa- by the operator and working at the facility. If a breach in security occurs, cility in which the person agrees to APHIS may extend the quarantine pe- comply with paragraph (c) of this sec- riod as long as necessary to determine tion and applicable provisions of this that the horses are free of commu- part, all terms of the compliance nicable diseases. agreement, and any related instruc- (4) Operating procedures. The fol- tions from APHIS representatives per- lowing procedures must be observed at taining to import quarantine oper- the facility at all times: ations, including contact with animals (i) Oversight by APHIS representatives. both inside and outside the facility. (A) Import quarantine operations at a (iii) Authorized access. Access to the privately owned quarantine facility facility premises as well as inside the may only be conducted with the phys- quarantine area will be granted only to ical presence of and monitoring by APHIS representatives, authorized em- APHIS representatives. APHIS rep- ployees, and other personnel of the op- resentatives are also authorized to per- erator assigned to work at the facility. form the services required by this sec- All other persons are prohibited from tion and by the compliance agreement. the premises unless specifically grant- (B) If, as the result of a spot audit, or ed access by an APHIS representative. for any other reason, APHIS deter- Any visitors granted access must be ac- mines that the operator has failed to companied at all times by an APHIS properly care for, feed, or handle quar- representative while on the premises or antined horses as required in this para- in the quarantine area of the facility. graph (c) or in accordance with the (iv) Sanitary requirements. (A) All per- terms of the compliance agreement, or sons granted access to the quarantine has failed to maintain and operate the area must: facility as provided in this paragraph (1) Shower when entering and leaving (c) or in accordance with the terms of the quarantine area; the compliance agreement, APHIS rep- (2) Shower when leaving the necropsy resentatives will furnish such services, area if a necropsy is in the process of will make arrangements for the sale or being performed or has just been com- disposal of quarantined horses at the pleted, or if all or portions of the exam- quarantine facility owner’s expense, or ined animal remain exposed; will begin the process for withdrawal of (3) Wear clean protective work cloth- approval of the quarantine facility ing and footwear upon entering the specified in paragraph (c)(1)(iv) of this quarantine area; section. (4) Wear disposable gloves when han- (ii) Personnel. (A) The operator must dling sick horses and then wash hands provide adequate personnel to main- after removing gloves; and tain the facility and care for the horses (5) Change protective clothing, foot- in quarantine, including attendants to wear, and gloves when they become care for and feed horses, and other per- soiled or contaminated. sonnel as needed to maintain, operate, (B) The operator is responsible for and administer the facility. providing a sufficient supply of cloth- (B) The operator must provide APHIS ing and footwear to ensure that all per- with an up-to-date list of all personnel sons provided access to the quarantine

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area at the facility have clean, protec- and disinfected after each use in active clothing, and footwear when they cordance with the terms of the compli- enter the quarantine area. ance agreement within a time period (C) The operator is responsible for authorized by the APHIS representa- the handling, washing, and disposal of tive and with a disinfectant authorized soiled and contaminated clothing worn in part 71 of this chapter or otherwise within the quarantine facility in ac- approved by the Administrator. APHIS cordance with the terms of the compli- representatives may conduct spot au- ance agreement. At the end of each dits of all cleaning and disinfection of workday, work clothing worn into the the loading dock. quarantine area must be collected and (G) That area of the facility in which kept in a bag until the clothing is a lot of horses has been held or has had washed. Used footwear must either be access to must be thoroughly cleaned left in the clothes-changing area or and disinfected, with a disinfectant au- cleaned with hot water (148 °F min- thorized in part 71 of this chapter or imum) and detergent and disinfected in otherwise approved by the Adminis- accordance with the terms of the com- trator, in accordance with the terms of pliance agreement. APHIS representa- the compliance agreement, upon re- tives may conduct spot audits of all lease of the horses before a new lot of handling, cleaning, and/or disposal of horses is placed in that area of the fa- used clothing or used footwear. cility. APHIS representatives may con- (D) All equipment (including trac- duct spot audits of all cleaning and dis- tors) must be cleaned and disinfected infection of lot-holding areas. prior to being used in the quarantine (v) Handling of the horses in quar- area of the facility with a disinfectant antine. (A) All horses must be handled authorized in part 71 of this chapter or in accordance with paragraph (a) of otherwise approved by the Adminis- this section. trator. The equipment must remain (B) Each lot of horses to be quar- dedicated to the facility for the entire antined must be placed in the facility quarantine period. Any equipment used on an ‘‘all-in, all out’’ basis. No horse with quarantined horses (e.g., halters, may be taken out of the lot while it is floats, feed, water buckets, and exer- in quarantine, except for diagnostic cise equipment) must remain dedicated purposes or as provided in paragraph to that particular lot of quarantined (a)(4) of this section, and no horse may horses for the duration of the quar- be added to the lot while the lot is in antine period or be cleaned and dis- quarantine. Once import quarantine infected before coming in contact with operations have been completed on a horses from another lot. Prior to its re- lot, but while the lot is still at the fa- moval from the quarantine premises, cility, a horse may be removed from any equipment must be cleaned and that lot. disinfected in accordance with the (C) The facility must provide suffi- terms of the compliance agreement. cient feed and bedding for the horses in APHIS representatives may conduct quarantine, and it must be free of spot audits of all cleaning and disinfec- vermin and not spoiled. Feed and bed- tion of equipment. ding must originate from an area that (E) Any vehicle, before entering or is not listed in part 72 of this chapter leaving the quarantine area of the fa- as an area quarantined for splenetic or cility, must be cleaned and disinfected tick fever. in accordance with the terms of the (D) Breeding of horses or collection compliance agreement within a time of germplasm from horses is prohibited period authorized by the APHIS rep- during the quarantine period. resentative and with a disinfectant au- (E) Horses in quarantine will be sub- thorized in part 71 of this chapter or jected to such tests and procedures as otherwise approved by the Adminis- directed by an APHIS representative to trator. APHIS representatives may determine whether they are free from conduct spot audits of all cleaning and communicable diseases of horses. disinfection of vehicles. (F) Any death or suspected illness of (F) If the facility has a single loading horses in quarantine must be reported dock, the loading dock must be cleaned immediately to APHIS. The affected

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horses must be disposed of as the Ad- deny or suspend approval of the facility ministrator may direct, or depending until appropriate remedial measures on the nature of the disease, must be have been applied. cared for as directed by APHIS to pre- (6) Variances. The Administrator may vent the spread of the disease. grant variances to existing require- (G) Quarantined horses requiring spe- ments relating to location, construc- cialized medical attention or addition, and other design features of the tional postmortem testing may be physical facility, as well as to sanita- transported off the quarantine site, if tion, security, operating procedures, authorized by APHIS. A second quar- recordkeeping, and other provisions of antine site must be established to paragraph (c) of this section, but only house the horses at the facility of des- if the Administrator determines that tination (e.g., veterinary teaching hos- the variance causes no detrimental im- pital). In such cases, APHIS may ex- pact to the overall biological security tend the quarantine period for that of the import quarantine operations. horse and for its lot until the results of The operator must submit a request for any outstanding tests or postmortem a variance from the requirements for results are received. the construction of the facility in para- (H) Should a horse be determined to graph (c)(3) of this section to the Ad- be infected with or exposed to a Feder- ministrator in writing prior to the con- ally regulated disease of horses, ar- struction of the facility. The operator rangements for the final disposition of must submit a request for a variance the infected or exposed horse must be from the operational requirements in accomplished within 10 days of the date paragraph (c)(4) of this section to the that the importer is notified by the Administrator in writing at least 30 overseeing APHIS representative that days in advance of the arrival of horses the horse has been refused entry into to the facility. Any variance must also the United States. APHIS representa- be expressly provided for in the compli- tives must be physically present at and ance agreement. directly monitor the subsequent dis- (Approved by the Office of Management and position of the horse. The operator Budget under control number 0579–0313) must have a preapproved contingency [55 FR 31495, Aug. 2, 1990] plan for the disposal of all horses housed at the facility prior to issuance EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 93.308, see the List of CFR of the import permit. Sections Affected, which appears in the (I) Vaccination of horses in quar- Finding Aids section of the printed volume antine is prohibited. However, once im- and at www.fdsys.gov. port quarantine operations have been completed on a lot, but while the lot is § 93.309 Horse quarantine facilities; still at the facility, horses in that lot payment information. may be vaccinated. (a) Privately operated quarantine facili- (vi) Records. (A) The facility operator ties. The importer, or his or her agent, must maintain a current daily record of horses subject to quarantine under to record the entry and exit of all per- the regulations in this part shall ar- sons entering and leaving the quar- range for acceptable transportation to antine facility. the privately operated quarantine fa- (B) The operator must maintain the cility and for the care, feed, and han- daily record, along with any records dling of the horses from the time of un- kept by APHIS and deposited with the loading at the quarantine port to the operator, for at least 2 years following time of release from quarantine. Such the date of release of the horses from arrangements shall be agreed to in ad- quarantine and must make such vance by the Administrator. All ex- records available to APHIS representa- penses resulting therefrom or incident tives upon request. thereto shall be the responsibility of (5) Environmental quality. If APHIS the importer; APHIS assumes no re- determines that a privately operated sponsibility with respect thereto. The quarantine facility does not meet ap- quarantine facility must be suitable for plicable local, State, or Federal envi- the quarantine of such horses and must ronmental regulations, APHIS may be approved by the Administrator prior

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to the issuance of any import permit. against the United States and APHIS The facilities occupied by horses or any employee of APHIS, for dam- should be kept clean and sanitary to ages which may arise from such serv- the satisfaction of the inspector as- ices. All expenses resulting therefrom signed to supervise the quarantine. If or incident thereto shall be the respon- for any cause the care, feed, or han- sibility of the importer; APHIS as- dling of horses, or the sanitation of the sumes no responsibility with respect facilities, is neglected, in the opinion thereto. The Administrator may pre- of the inspector assigned to supervise scribe reasonable rates for the services the quarantine, such services may be provided under this paragraph. When it furnished by APHIS in the same man- is found necessary to extend the usual ner as though arrangements had been minimum quarantine period, the im- made for such services as provided by porter, or his or her agent, shall be so paragraph (b) of this section, and/or the advised in writing and shall pay for horses may be disposed of as the Ad- such additional quarantine and other ministrator, may direct, including sale services required. Payment for services in accordance with the procedure de- received by the importer, or his or her scribed in paragraph (b) of this section. agent, in connection with each sepa- The importer, or his or her agent, shall rate lot of horses shall be made by cer- request in writing such inspection and tified check or U.S. money order prior other services as may be required, and to release of the horses. If such pay- shall waive all claim against the ment is not made, the horses may be United States and APHIS or any em- sold in accordance with the procedure ployee of APHIS for damages which described in this paragraph or other- may arise from such services. The Ad- wise disposed of as directed by the Ad- ministrator, may prescribe reasonable ministrator. When payment is not rates for the services provided under this paragraph. When it is found nec- made and the horses are to be sold to essary to extend the usual minimum recover payment for services received, quarantine period, the importer, or his the importer, or his or her agent, will or her agent, shall be so advised in be notified by the inspector that if said writing and shall pay for such addi- charges are not immediately paid or tional quarantine and other services satisfactory arrangements made for required. Payment for all services re- payment, the horses will be sold at ceived by the importer, or his or her public sale to pay the expense of care, agent, in connection with each sepa- feed, and handling during that period. rate lot of horses shall be made by cer- The sale will be held after the expira- tified check or U.S. money order prior tion of the quarantine period, at such to release of the horses. If such pay- time and place as may be designated by ment is not made, the horses may be the General Services Administration or sold in accordance with the procedure other designated selling agent. The described in paragraph (b) of this sec- proceeds of the sale, after deducting tion, or otherwise disposed of as di- the charges for care, feed, and handling rected by the Administrator. of the horses and other expenses, in- (b) Quarantine facilities maintained by cluding the expense of the sale, shall be APHIS. The importer, or his or her held in a Special Deposit Account in agent, of horses subject to quarantine the United States Treasury for 6 under the regulations in this part shall months from the date of sale. If not arrange for acceptable transportation claimed by the importer, or his or her to the quarantine facility, and for the agent, within 6 months from the date care, feed, and handling of the horses of sale, the amount so held shall be from the time they arrive at the quar- transferred from the Special Deposit antine port to the time of release from Account to the General Fund Account quarantine. Such arrangements shall in the United States Treasury. be agreed to in advance by the Admin- (c) Amounts collected from the im- istrator. The importer or his or her porter, or his or her agent, for service agent shall request in writing such in- rendered shall be deposited so as to be spection and other services as may be available for defraying the expenses in- required, and shall waive all claim volved in this service.

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§ 93.310 Quarantine stations, visiting as the Administrator may direct, de- restricted; sales prohibited. pending upon the nature of the disease. Visitors are not permitted in the quarantine enclosure during any time § 93.314 Horses, certification, and accompanying equipment. that the horses are in quarantine unless an APHIS representative specifi- (a) Horses offered for importation cally grants access under such condi- from any part of the world shall be actions and restrictions as may be im- companied by a certificate of a salaried posed by APHIS. An importer (or his or veterinary officer of the national gov- her agent or accredited veterinarian) ernment of the region of origin, or if may be admitted to the lot-holding exported from Mexico, shall be accom- area(s) containing his or her quar- panied either by such a certificate or antined horses at such intervals as by a certificate issued by a veteri- may be deemed necessary, and under narian accredited by the National Gov- such conditions and restrictions as ernment of Mexico and endorsed by a may be imposed, by an APHIS rep- full-time salaried veterinary officer of resentative. On the last day of the the National Government of Mexico, quarantine period, owners, officers or thereby representing that the veteri- registry societies, and others having narian issuing the certificate was au- official business or whose services may thorized to do so, showing that: be necessary in the removal of the (1) The horses described in the cer- horses may be admitted upon written tificate have been in said region during permission from an APHIS representa- the 60 days preceding exportation; tive. No exhibition or sale shall be al- (2) That each horse has been in- lowed within the quarantine grounds. spected on the premises of origin and [74 FR 31601, July 2, 2009] found free of evidence of communicable disease and, insofar as can be deter- § 93.311 Milk from quarantined horses. mined, exposure thereto during the 60 Milk or cream from horses quar- days preceding exportation; antined under the provisions of this (3) That each horse has not been vac- part shall not be used by any person cinated with a live or attenuated or in- other than those in charge of such activated vaccine during the 14 days horses, nor be fed to any animals other preceding exportation: Provided, how- than those within the same enclosure, ever, that in specific cases the Adminis- without permission of the inspector in trator may authorize horses that have charge of the quarantine station and been vaccinated with an inactivated subject to such restrictions as he or vaccine to enter the United States she may consider necessary to each in- when he or she determines that in such stance. No milk or cream shall be re- cases and under such conditions as he moved from the quarantine premises or she may prescribe such importation except in compliance with all State will not endanger the livestock in the and local regulations. United States, and such horses comply with all other applicable requirements § 93.312 Manure from quarantined of this part; horses. (4) That, insofar as can be deter- No manure shall be removed from the mined, no case of African horse sick- quarantine premises until the release ness, dourine, glanders, surra, epizootic of the horses producing same. lymphangitis, ulcerative lymphangitis, equine piroplasmosis, Venezuelan § 93.313 Appearance of disease among equine encephalomyelitis, vesicular horses in quarantine. stomatitis, or equine infectious anemia If any contagious disease appears has occurred on the premises of origin among horses during the quarantine or on adjoining premises during the 60 period special precautions shall be days preceding exportation; and taken to prevent spread of the infec- (5) That, except as provided in tion to other animals in the quarantine § 93.301(g): station or to those outside the grounds. (i) The horses have not been in any The affected horses shall be disposed of region listed in § 93.301(c)(1) as affected

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with CEM during the 12 months imme- agent shall present two copies of a dec- diately prior to their importation into laration as provided in § 93.305. the United States; [55 FR 31495, Aug. 2, 1990. Redesignated and (ii) The horses have not been on any amended at 62 FR 56012, 56017, Oct. 28, 1997] premises at any time during which time such premises were found by an § 93.316 Horses from Canada for imme- official of the veterinary services of diate slaughter. the national government of the region Horses imported from Canada for im- where such premises are located, to be mediate slaughter shall be consigned affected with CEM; from the port of entry directly to a rec- (iii) The horses have not been bred by ognized slaughtering establishment or bred to any horses from an affected and there be slaughtered within two premises; and weeks from the date of entry. Such (iv) The horses have had no other horses shall be inspected at the port of contact with horses that have been entry and otherwise handled in accord- found to be affected with CEM or with ance with § 93.306. As used in this sec- horses that were imported from regions tion, ‘‘directly’’ means without unload- affected with CEM. ing en route if moved in a means of (b) If a horse is presented for impor- conveyance, or without stopping if tation from a region where it has been moved in any other manner. for less than 60 days, the horse must be [55 FR 31495, Aug. 2, 1990, as amended at 59 accompanied by a certificate that FR 28216, June 1, 1994. Redesignated and meets the requirements of paragraph amended at 62 FR 56012, 56017, Oct. 28, 1997] (a) of this section that has been issued by a salaried veterinary officer of the § 93.317 Horses from Canada. national government of each region in (a) Except as provided in paragraph which the horse has been during the 60 (c) of this section, horses from Canada days immediately preceding its ship- shall be inspected as provided in ment to the United States. The dates § 93.306; shall be accompanied by a cer- during which the horse was in each re- tificate as required by § 93.314 which gion during the 60 days immediately shall include evidence of a negative preceding its exportation to the United test for equine infectious anemia for States shall be included as a part of the which blood samples were drawn during certification. the 180 days preceding exportation to (c) Following the port-of-entry in- the United States and which test was spection required by § 93.306 of this conducted in a laboratory approved by part, and before a horse offered for im- the Canada Department of Agriculture portation from any part of the world is or the United States Department of released from the port of entry, an in- Agriculture; Except, that horses accom- spector may require the horse and its panying their dams which were foaled accompanying equipment to be dis- after their dam was so tested negative infected as a precautionary measure need not be so tested; and shall other- against the introduction of foot-and- wise be handled as provided in § 93.314: mouth disease or any other disease Provided, however, That certificates re- dangerous to the livestock of the quired for horses from Canada may be United States. either issued or endorsed by a salaried [61 FR 52245, Oct. 7, 1996. Redesignated and veterinarian of the Canadian Govern- amended at 62 FR 56012, 56017, Oct. 28, 1997; 63 ment: And provided, further, That FR 53783, Oct. 7, 1998] USDA veterinary port inspection is not required for horses imported from Can- CANADA 16 ada under temporary Customs authorization for a period of 30 days from the § 93.315 Import permit and declaration date of issue of the certificate and the for horses. certificate issued is valid for an unlim- For all horses offered for importation ited number of importations into the from Canada, the importer or his or her United States during the 30-day period.

16 Importations from Canada shall be sub- dition to other sections in this part which ject to §§ 93.315, 93.316, 93.317 and 93.318, in ad- are in terms applicable to such importations.

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(b) Horses of United States origin livestock or poultry of the United that are imported into Canada under States. an export health certificate valid for a (2) In-transit shipments through Can- period of 30 days from the date of issue ada. Horses originating in the United may re-enter the United States an un- States and transported directly limited number of times during the 30- through Canada may re-enter the day period, without USDA veterinary United States without Canadian health port inspection, at any Custom land or test certificates when accompanied border port of entry designated for ani- by copies of the United States export mals from Canada, if accompanied by health certificates properly issued and the original export health certificate endorsed in accordance with regula- under which they were permitted entry tions in part 91 of this chapter: Pro- into Canada. vided, That, to qualify for entry, the (c) Horses for immediate slaughter date, time, port of entry, and signature may be imported from Canada without of the Canadian Port Veterinarian that the certification prescribed in para- inspected the horses for entry into graph (a) of this section, but shall be Canada shall be recorded on the United subject to the other applicable provi- States health certificate, or a paper sions of this part, and shall be accom- containing the information shall be at- panied by a certificate issued or en- tached to the certificate that accom- dorsed by a salaried veterinarian of the panies the horses. In all cases it shall Canadian Government stating that: be determined by the veterinary in- (1) The horses were inspected on the spector at the United States port of premises where assembled for shipment entry that the horses are the identical to the United States within the 30 days horses covered by said certificate. immediately prior to the date of export (b) Exhibition horses. Except as pro- and were found free of evidence of com- vided in § 93.317(b), horses from the municable disease, and United States which have been exhib- (2) As far as can be determined, they ited at the Royal Agricultural Winter have not been exposed to any such dis- Fair at Toronto or other publicly rec- ease during the 60 days immediately ognized expositions in Canada, includ- preceding their exportation. ing racing, horse shows, rodeo, circus, or stage exhibitions in Canada, and [55 FR 31495, Aug. 2, 1990, as amended at 56 have not been in that region for more FR 33863, July 24, 1991. Redesignated and than 90 days are eligible for return to amended at 62 FR 56012, 56017, Oct. 28, 1997] the United States without Canadian health or test certificates, if they are § 93.318 Special provisions. accompanied by copies of the United (a) In-bond shipments from Canada. (1) States health certificate, issued and Horses from Canada transported in- endorsed in accordance with the export bond through the United States for im- regulations contained in part 91 of this mediate export shall be inspected at chapter for entry into Canada: Pro- the border port of entry and, when ac- vided, That in the case of horses for ex- companied by an import permit ob- hibition, including race horses, the cer- tained under § 93.304 of this part and all tificates shall certify that negative re- conditions therein are observed, shall sults were obtained from official tests be allowed entry into the United States for equine infectious anemia for which and shall be otherwise handled as pro- blood samples were drawn within 180 vided in paragraph (b) of § 93.301. Horses days of the date that the horses are of- not accompanied by a permit shall fered for return to the United States: meet the requirements of this part in And, provided further, That all horses the same manner as horses destined for offered for re-entry upon examination importation into the United States, ex- by the veterinary inspector at the U.S. cept that the Administrator may per- port of entry, are found by the inspec- mit their inspection at some other tor to be free of communicable diseases point when he or she finds that such and exposure thereto and are deter- action will not increase the risk that mined to be the identical horses cov- communicable diseases of livestock ered by said certificates or are the nat- and poultry will be disseminated to the ural increase of such horses born after

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official test dates certified on the factory arrangements for the orderly dam’s health certificate. inspection of the horses. The veteri- [55 FR 31495, Aug. 2, 1990. Redesignated and nary inspector at the port of entry will amended at 62 FR 56012, 56017, Oct. 28, 1997] provide the importer or his or her agent with a written statement assign- CENTRAL AMERICA AND THE WEST ing a date when the horses may be pre- INDIES 17 sented for import inspection.

§ 93.319 Import permit and declaration § 93.322 Declaration for horses. for horses. For all horses offered for importation For all horses offered for importation from Mexico, the importer or his or her from regions of Central America or of agent shall present two copies of a dec- the West Indies, the importer or his or laration as provided in § 93.305. her agent shall present two copies of a declaration as provided in § 93.305. [55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56017, Oct. 28, 1997] [55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56017, Oct. 28, 1997] § 93.323 Inspection. § 93.320 Horses from Central America (a) All horses offered for entry from and the West Indies. Mexico, including such horses intended Horses from Central America and the for movement through the United West Indies shall be inspected as pro- States in bond for immediate return to vided in § 93.306; shall be accompanied Mexico, shall be inspected at a facility by a certificate and otherwise handled described in § 93.324, and all such horses as provided in § 93.314; and shall be found to be free from communicable quarantined and tested as provided in disease and fever tick infestation, and § 93.308(a), (b) and (c): Provided, That not to have been exposed thereto, shall any such horses that are found to be in- be admitted into the United States fested with fever ticks, Boophilus subject to the other applicable provi- annulatus, shall not be permitted entry sions of this part. Horses found to be until they have been freed therefrom affected with or to have been exposed by dipping in a permitted arsenical so- to a communicable disease, or infested lution or by other treatment approved with fever ticks, shall be refused entry. by the Administrator. Horses refused entry, unless exported [55 FR 31495, Aug. 2, 1990. Redesignated and within a time fixed in each case by the amended at 62 FR 56012, 56017, Oct. 28, 1997] Administrator, shall be disposed of as said Administrator may direct. MEXICO 18 (b) Horses covered by paragraph (a) of § 93.321 Import permits and applica- this section shall be imported through tions for inspection for horses. facilities described in § 93.324, which are For horses intended for importation equipped with facilities necessary for into the United States from Mexico, proper chute inspection, dipping, and the importer or his or her agent shall testing, as provided in this part. deliver to the veterinary inspector at [55 FR 31495, Aug. 2, 1990, as amended at 58 the port of entry an application, in FR 45238, Aug. 27, 1993. Redesignated at 62 FR writing, for inspection, so that the vet- 56012, 56017, Oct. 28, 1997] erinary inspector and customs representatives may make mutually satis- § 93.324 Detention for quarantine. Horses intended for importation from 17 Importations from regions of Central Mexico shall be quarantined until they America and the West Indies shall be subject qualify for release from such quar- to §§ 93.319 and 93.320, in addition to other antine, either at an APHIS facility des- sections in this subpart, which are in terms ignated in § 93.303 (a) or at a facility in applicable to such importations. 18 Importations from Mexico shall be sub- Mexico. In order to qualify for such re- ject to §§ 93.321 to 93.326 inclusive, in addition lease, all horses while so detained shall to other sections in this subpart which are in test negative to an official test for dou- terms applicable for such importations. rine, glanders, equine piroplasmosis,

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equine infectious anemia, 19 and such sions of §§ 93.321, 93.322, and 93.323 for other tests that may be required by the immediate slaughter if accompanied by Administrator to determine their free- a certificate of a salaried veterinarian dom from other communicable dis- of the Mexican Government, or by a eases. Such horses shall also be sub- certificate issued by a veterinarian ac- jected to such other inspections and credited by the Mexican Government disinfections deemed necessary by the and endorsed by a salaried veterinarian Administrator, and they shall be re- of the Mexican Government, thereby leased from quarantine only if found to representing that the veterinarian be free from any communicable disease issuing the certificate was authorized upon inspection. to do so, stating that he or she has inspected such horses on the premises of [55 FR 31495, Aug. 2, 1990, as amended at 56 FR 15489, Apr. 17, 1991; 58 FR 45238, Aug. 27, origin and found them free of evidence 1993; 59 FR 67614, Dec. 30, 1994; 60 FR 5128, of communicable disease, and that, so Jan. 26, 1995; 61 FR 39853, July 31, 1996; 61 FR far as it has been possible to deter- 52246, Oct. 7, 1996. Redesignated at 62 FR mine, they have not been exposed to 56012, 56017, Oct. 28, 1997, as amended at 63 FR any such disease common to animals of 3640, Jan. 26, 1998] their kind during the preceding 60 days, and if the horses are shipped by § 93.325 Horses from Mexico. rail or truck, the certificate shall fur- Horses offered for entry from Mexico ther specify that the horses were load- shall be inspected as provided in ed into cleaned and disinfected cars or §§ 93.306 and 93.323; shall be accom- trucks for transportation directly to panied by a certificate and otherwise the port of entry. Such horses shall be handled as provided in § 93.314; and consigned from a facility described in shall be quarantined and tested as pro- § 93.324 to a recognized slaughtering es- vided in § 93.324: Provided, That horses tablishment and there slaughtered offered for importation from tick-in- within 2 weeks from the date of entry. fected areas of Mexico shall be chute Such horses shall be moved from the inspected, unless in the judgment of port of entry in conveyances sealed the inspector a satisfactory inspection with seals of the United States Govern- can be made otherwise. If upon inspec- ment. tion they are found to be apparently [55 FR 31495, Aug. 2, 1990, as amended at 57 free from fever ticks, before entering FR 28080, June 24, 1992; 58 FR 45238, Aug. 27, the United States they shall be dipped 1993; 60 FR 5128, Jan. 26, 1995; 61 FR 39853, once in a permitted arsenical solution July 31, 1996. Redesignated and amended at or be otherwise treated in a manner ap- 62 FR 56012, 56017, Oct. 28, 1997; 63 FR 3640, proved by the Administrator. Jan. 26, 1998] [55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56017, Oct. 28, 1997] Subpart D—Ruminants

§ 93.326 Horses for immediate slaugh- SOURCE: 55 FR 31495, Aug. 2, 1990, unless ter. otherwise noted. Redesignated at 62 FR 56012, Horses may be imported from Mex- Oct. 28, 1997. ico, subject to the applicable provi- § 93.400 Definitions.

19 In view of the fact that official test for Wherever in this subpart the fol- dourine and glanders are run exclusively at lowing terms are used, unless the con- the National Veterinary Services Labora- text otherwise requires, they shall be tory, Ames, Iowa, protocols for these tests construed, respectively, to mean: have not been published and are therefore Accredited herd. An accredited herd is not available; copies of ‘‘Protocol for the one that has passed at least two con- Complement-Fixation Test for Equine secutive annual official tuberculin Piroplasmosis’’ and ‘‘Protocol for the tests and has no evidence of bovine tu- Immuno-Diffusion (Coggins) Test for Equine berculosis. All animals in a herd must Infectious Anemia’’ may be obtained from the Animal and Plant Health Inspection be free from tuberculosis. Service, Veterinary Services, National Cen- Accredited veterinarian. A veteri- ter for Import-Export, 4700 River Road Unit narian approved by the Administrator 38, Riverdale, Maryland 20737–1231. in accordance with the provisions of

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part 161 of this title to perform func- an agreement with Veterinary Services tions specified in parts 1, 2, 3, and 11 of in which the management of the facil- subchapter A, and subchapters B, C, ity agrees that only designated individ- and D of this chapter, and to perform uals will break the seals, that the facil- functions required by cooperative ity will contact an APHIS representa- state-federal disease control and eradi- tive or USDA Food Safety and Inspec- cation programs. tion Service inspector immediately if Administrator. The Administrator of the seals are not intact when the the Animal and Plant Health Inspec- means of conveyance arrives or if the tion Service or any other employee of animals being transported appear to be the Animal and Plant Health Inspec- sick or injured due to transport condition Service, United States Depart- tions, and that the facility will cooper- ment of Agriculture, to whom author- ate with APHIS representatives, USDA ity has been or may be delegated to act Food Safety and Inspection Service in- in the Administrator’s stead. spectors, and State representatives in Animal and Plant Health Inspection maintaining records of sealed ship- Service. Animal and Plant Health In- ments received. spection Service of the United States Bovine. Bos taurus, Bos indicus, and Department of Agriculture (APHIS or Bison bison. Service). Bovine spongiform encephalopathy Animals. Cattle, sheep, goats, other (BSE) minimal risk region. A region list- ruminants, swine, horses, asses, mules, ed in § 94.18(a)(3) of this subchapter. zebras, dogs, and poultry. Brucellosis certified free herd. A herd in APHIS representative. A veterinarian which all eligible cattle in the herd or other individual employed by the were negative to brucellosis tests Animal and Plant Health Inspection under the Canadian requirements and Service, United States Department of which is officially certified by the Ca- Agriculture, who is authorized to per- nadian Government as a brucellosis form the services required by this part. free listed herd. Area veterinarian in charge (AVIC). Brucellosis certified-free province or ter- The veterinary official of APHIS who is ritory of Canada. A province or terri- assigned by the Administrator to su- tory of Canada in which all herds of pervise and perform the official animal cattle are brucellosis certified free. health work of APHIS in the State con- The brucellosis certified free provinces cerned. and territories of Canada are Alberta, As a group. Collectively, in such a British Columbia, Manitoba, New manner that the identity of the ani- Brunswick, Newfoundland (including mals as a unique group is maintained. Labrador), Northwest Territories, Nova Authorized USDA representative. An Scotia, Ontario, Quebec, Prince Edward APHIS Veterinary Services employee, Island, Saskatchewan, and Yukon Ter- a USDA Food Safety and Inspection ritory. Service inspector, a State representative, an accredited veterinarian, or an Camelid. All species of the family employee of an accredited veteri- Camelidae, including camels, guanacos, narian, slaughtering establishment, or llamas, alpacas, and vicunas. feedlot who is designated by the ac- Cattle. Animals of the bovine species. credited veterinarian or management Cervid. All members of the family of the slaughtering establishment or Cervidae and hybrids, including deer, feedlot to perform the function in- elk, moose, caribou, reindeer, and re- volved. In order to designate an em- lated species. ployee to break official seals, an ac- Communicable disease. Any con- credited veterinarian or the manage- tagious, infectious, or communicable ment of a slaughtering establishment disease of domestic livestock, poultry or feedlot must first supply in writing or other animals. the name of the designated individual Department. The United States De- to the APHIS AVIC in the State where partment of Agriculture (USDA). the seals will be broken. Additionally, Designated feedlot. A feedlot that has the management of a slaughtering es- been designated by the Administrator tablishment or feedlot must enter into as one that is eligible to receive sheep

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and goats imported from a BSE mini- and slaughtered within 2 weeks from mal-risk region and whose owner or le- the date of entry. gally responsible representative has Inspector. Any individual authorized signed an agreement in accordance by the Administrator of APHIS or the with § 93.419(d)(8) of this subpart to ad- Commissioner of Customs and Border here to, and is in compliance with, the Protection, Department of Homeland requirements for a designated feedlot. Security, to enforce the regulations in Federal veterinarian. A veterinarian this subpart. employed and authorized by the Fed- Lot. A group of ruminants that, while eral Government to perform the tasks held on a conveyance or premises, has required by this subpart. opportunity for physical contact with Fever tick. Boophilus annulatus, in- each other or with each other’s excre- cluding, but not limited to, the vari- ment or discharges at any time be- eties Americana and Australia. tween arrival at the quarantine facility Flock. Any group of one or more and 60 days prior to export to the sheep maintained on common ground; United States. or two or more groups of sheep under Lot-holding area. That area in a pri- common ownership or supervision on vately owned medium or minimum se- two or more premises that are geo- curity quarantine facility in which a graphically separated, but among single lot of ruminants is held at one which there is an interchange or move- time. ment of animals. Moved directly. Moved without un- Herd. Any group of one or more ani- loading and without stopping except mals maintained on common ground; for refueling, or for traffic conditions or two or more groups of animals under such as traffic lights or stop signs. common ownership or supervision on Moved directly by land. Moved by rail, two or more premises that are geo- truck, or other land vehicle without graphically separated, but among unloading and without stopping except which there is an interchange or move- for refueling, or for traffic conditions ment of animals. such as traffic lights or stop signs. Herd of origin. The herd within which Nonquarantine area. That area of a an individual animal was born and privately owned medium or minimum raised and that was maintained on security quarantine facility that in- common ground for at least 4 months. cludes offices, storage areas, and other For a group of one or more animals to areas outside the quarantine area, and qualify as a herd of origin for the pur- that is off limits to ruminants, samples poses of § 93.406, animals may be added taken from ruminants, and any other to the herd during or after the 4-month objects or substances that have been in qualifying period only if they: the quarantine area during the quar- (1) Originated from a tuberculosis- antine of ruminants. free herd; or Official identification device or method. (2) Originated from an accredited A means of officially identifying an herd or originated from a herd of origin animal or group of animals using de- that tested negative to a whole herd vices or methods approved by the Ad- test, and the individual cattle to be ministrator, including, but not limited added to the herd also tested negative to, official tags, tattoos, and registered to any additional individual tests for brands when accompanied by a certifi- tuberculosis required by the Adminis- cate of inspection from a recognized trator. brand inspection authority. For ani- Immediate slaughter. Consignment di- mals intended for importation into the rectly from the port of entry to a rec- United States, the device or method of 1 ognized slaughtering establishment identification used must have been approved by the Administrator for that 1 The name of recognized slaughtering es- type of import before the animal is ex- tablishments approved under this part may ported to the United States. be obtained from the area veterinarian in charge for the State of destination of the shipment. The name and address of the area spection Service, Veterinary Services, Na- veterinarian in charge in any State is avail- tional Center for Import and Export, 4700 able from the Animal and Plant Health In- River Road Unit 39, Riverdale, MD 20737–1231.

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Official tuberculin test. A test for bo- quirements for medium security facili- vine tuberculosis that is approved by ties in § 93.412(d); and the Administrator as equivalent to the (4) Provides the necessary level of international standard test described quarantine services for the holding of in the Manual of Standards for Diag- ruminants in an indoor, vector-proof nostic Tests and Vaccines, Office Inter- environment prior to the animals’ national des Episodes, and that is ad- entry into the United States. Quar- ministered and reported by a full-time antine services would have to include salaried veterinary officer of the na- testing or observation for any OIE list- tional government of the region of ori- ed diseases and other livestock diseases gin, or administered and reported by a exotic to the United States, as well as veterinarian designated or accredited any other diseases, as necessary, to be by the national government of the re- determined by the Administrator. gion of origin and endorsed by a full- Privately owned minimum security time salaried veterinary officer of the quarantine facility (minimum security fa- national government of the region of cility). A facility that: origin, representing that the veteri- (1) Is owned, operated, and financed narian issuing the certificate was au- by a person other than the Federal thorized to do so. Government; Officially identified. Individually iden- (2) Is subject to the strict oversight tified by means of an official identi- of APHIS representatives; fication device or method. (3) Is constructed, operated, and Operator. A person other than the maintained in accordance with the re- Federal Government who owns or oper- quirements for minimum security fa- ates, subject to APHIS’ approval and cilities in § 93.412(d); oversight, a privately owned medium (4) Is used for the quarantine of or minimum security quarantine facil- ruminants that pose no significant ity. risk, as determined by the Adminis- Permitted dip. A dip permitted by the trator, of introducing or transmitting Administrator to be used in the official to the U.S. livestock population any dipping of cattle for fever ticks and for livestock disease that is biologically dipping cattle and sheep for scabies. transmissible by vectors; and (5) Provides the necessary level of Persons. Any individual, corporation, quarantine services for the outdoor company, association, firm, partner- holding of ruminants, prior to the ani- ship, society or joint stock company. mals’ entry into the United States. Port Veterinarian. A veterinarian em- Quarantine services would have to in- ployed by the Animal and Plant Health clude testing or observation for any Inspection Service to perform duties OIE listed diseases and other livestock required under this part at a port of diseases exotic to the United States, as entry. well as any other diseases, as nec- Positive for a transmissible spongiform essary, to be determined by the Admin- encephalopathy. A sheep or goat for istrator. which a diagnosis of a transmissible Quarantine area. That area of a pri- spongiform encephalopathy has been vately owned medium or minimum se- made. curity quarantine facility that com- Premises of origin. Except as otherwise prises all of the lot-holding areas in the used in § 93.423 of this subpart, the facility and any other areas in the fa- premises where the animal was born. cility that ruminants have access to, Privately owned medium security quar- including loading docks for receiving antine facility (medium security facility). and releasing ruminants, and any areas A facility that: used to conduct examinations of (1) Is owned, operated, and financed ruminants and take samples and any by a person other than the Federal areas where samples are processed or Government; examined. (2) Is subject to the strict oversight Recognized slaughtering establishment.2 of APHIS representatives; An establishment where slaughtering (3) Is constructed, operated, and maintained in accordance with the re- 2 See footnote 1.

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operations are regularly carried on gazing,’’ head pressing, recumbency, or under federal or state inspection and other signs of neurological disease or which has been approved by the Animal chronic wasting. and Plant Health Inspection Service to Swine. The domestic hog and all vari- receive animals for slaughter under eties of wild hogs. this part. Temporary inspection facility. A tem- Region. Any defined geographic land porary facility that is constructed of area identifiable by geological, polit- metal panels that can be erected and ical, or surveyed boundaries. A region broken down alongside the transpor- may consist of any of the following: tation vessel carrying ruminants that (1) A national entity (country); are imported into the United States in (2) Part of a national entity (zone, accordance with § 93.408 of this subpart county, department, municipality, par- and that will be quarantined at a min- ish, Province, State, etc.); imum or medium security quarantine (3) Parts of several national entities facilities located more than 1 mile combined into an area; or from the port of entry. (4) A group of national entities (coun- Tuberculosis-free herd. A herd which is tries) combined into a single area. not known to be infected with bovine Ruminants. All animals which chew tuberculosis (M. bovis) and which is cer- the cud, such as cattle, buffaloes, tified by the Canadian Government as sheep, goats, deer, antelopes, camels, a tuberculosis-free herd. llamas and giraffes. United States. All of the States of the State representative. A veterinarian or United States, the District of Colum- other person employed in livestock bia, Guam, Northern Mariana Islands, sanitary work by a State or political Puerto Rico, the Virgin Islands of the subdivision of a State who is author- United States, and all other Territories ized by such State or political subdivi- and Possessions of the United States. sion of a State to perform the function Veterinary Services. The Veterinary involved under a memorandum of un- Services unit of the Department. derstanding with APHIS. Wether. A castrated male sheep or State veterinarian. A veterinarian em- goat. ployed and authorized by a State or po- Whole herd test. An official tuberculin litical subdivision of a State to per- test of all cattle in a herd of origin form the tasks required by this sub- that are 6 months of age or older, and part. of all cattle in the herd of origin that Suspect for a transmissible spongiform are less than 6 months of age and were encephalopathy. (1) A sheep or goat that not born into the herd of origin, except has tested positive for a transmissible those cattle that are less than 6 spongiform encephalopathy or for the months of age and: proteinase resistant protein associated (1) Were born in and originated from with a transmissible spongiform a tuberculosis-free herd; or encephalopathy, unless the animal is (2) Were born in and originated from designated as positive for a trans- an accredited herd or originated from a missible spongiform encephalopathy; herd of origin that has tested negative or to a whole herd test, and the individual (2) A sheep or goat that exhibits any cattle have tested negative to any ad- of the following signs and that has ditional individual tests for tuber- been determined to be suspicious for a culosis required by the Administrator. transmissible spongiform World Organization for Animal Health encephalopathy by a veterinarian: (OIE). The international organization Weight loss despite retention of appe- recognized by the World Trade Organi- tite; behavior abnormalities; pruritus zation for setting animal health stand- (itching); wool pulling; biting at legs or ards, reporting global animal situa- side; lip smacking; motor abnormali- tions and disease status, and pre- ties such as incoordination, high step- senting guidelines and recommenda- ping gait of forelimbs, bunny hop tions on sanitary measures related to movement of rear legs, or swaying of animal health. back end; increased sensitivity to noise Zoological park. A professionally oper- and sudden movement; tremor, ‘‘star ated zoo, park, garden or other place,

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maintained under the constant surveil- under § 93.404 of this chapter and all lance of a Doctor of Veterinary Medi- conditions therein are observed; and if cine, for the exhibition of live animals, such ruminants are handled as follows: pigeons or birds, for the purpose of pub- (1)(i) They are maintained under con- lic recreation or education. tinuous confinement in transit through the United States aboard an aircraft, [55 FR 31495, Aug. 2, 1990. Redesignated at 62 ocean vessel, or other means of convey- FR 56012, Oct. 28, 1997] ance; or EDITORIAL NOTE: For FEDERAL REGISTER ci- (ii) They are unloaded, in the course tations affecting § 93.400, see the List of CFR of such transit, into a ruminant hold- Sections Affected, which appears in the ing facility which is provided by the Finding Aids section of the printed volume and at www.fdsys.gov. carrier or its agent and has been approved 5 in advance by the Adminis- § 93.401 General prohibitions; excep- trator in accordance with paragraph tions. (b)(3) of this section as adequate to prevent the spread within the United (a) No ruminant or product subject to States of any livestock disease, and the provisions of this part shall be they are maintained there under con- brought into the United States except tinuous confinement until loaded in accordance with the regulations in aboard a means of conveyance for this part and part 94 of this sub- transportation from the United States 3 chapter; nor shall any such ruminant and are maintained under continuous or product be handled or moved after confinement aboard such means of con- physical entry into the United States veyance until it leaves the United before final release from quarantine or States; the import permit will specify any other form of governmental deten- any additional conditions necessary to tion except in compliance with such assure that the transit of the regulations. Notwithstanding any ruminants through the United States other provision of this subpart, the im- can be made without endangering the portation of any ruminant that has livestock or poultry of the United been in a region listed in § 94.18(a)(1) or States, and that Department inspec- (a)(2) of this subchapter is prohibited. tors may inspect the ruminants on Provided, however, the Administrator board such means of conveyance or in may upon request in specific cases per- such holding facility to ascertain mit ruminants or products to be whether the requirements of this para- brought into or through the United graph are met, and dispose of them in States under such conditions as he or accordance with the Animal Health she may prescribe, when he or she de- Protection Act (7 U.S.C. 8301 et seq.) if termines in the specific case that such such conditions are not met; and action will not endanger the livestock (2) The carrier or its agent executes or poultry of the United States. and furnishes to the collector of Cus- (b) Except for ruminants prohibited toms at the first port of arrival a dec- entry, the provisions in this part relat- laration stating that the ruminants ing to ruminants shall not apply to will be retained aboard such means of healthy ruminants in transit through conveyance or in an approved holding the United States if they are not facility during transshipment as re- known to be infected with or exposed, quired by this paragraph. within 60 days preceding the date of ex- (3) Provisions for the approval of fa- port from the region of origin, to com- cilities required in this paragraph are: municable diseases of such ruminants, (i) They must be sufficiently isolated 4 if an import permit has been obtained to prevent direct or indirect contact with all other animals and birds while 3 Importations of certain animals from var- in the United States. ious regions are absolutely prohibited under (ii) They must be so constructed that part 94 because of specified diseases. they provide adequate protection 4 Such permit may be obtained from the Animal and Plant Health Inspection Service, Veterinary Services, National Center for Im- proval of such facilities should also be made port-Export, 4700 River Road Unit 38, River- to the Administrator. dale, Maryland 20737–1231. Requests for ap- 5 See footnote 4 to subpart D.

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against environmental conditions and the introduction or dissemination of can be adequately cleaned, washed and any communicable animal disease. disinfected. (b) Unloading requirements: Whenever (iii) They must provide for disposal of in the course of any such inspection at ruminant carcasses, manure, bedding, any port in the United States the in- waste and any related shipping mate- spector has reason to believe that the rials in a manner that will prevent dis- means of conveyance or container is semination of disease. contaminated with material of animal (iv) They must have provisions for (including poultry) origin, such as, but adequate sources of feed and water and for attendants for the care and feeding not limited to, meat, organs, glands, of ruminants in the facility. extracts, secretions, fat, bones, blood, (v) They must comply with addi- lymph, urine, or manure, so as to tional requirements as may be imposed present a danger of the spread of any by the Administrator if deemed appli- communicable animal disease, the in- cable for a particular shipment. spector may require the unloading of (vi) They must also comply with all the means of conveyance and the applicable local, State and Federal re- emptying of the container if he or she quirements for environmental quality deems it necessary to enable him or and with the provisions of the Animal her to determine whether the means of Welfare Regulations in chapter I of this conveyance or container is in fact so title, as applicable. contaminated. The principal operator (c) Removal and loss of official identi- of the means of conveyance and his or fication devices. Official identification her agent in charge of the means of devices are intended to provide perma- conveyance shall comply with any such nent identification of livestock and to requirement under the immediate su- ensure the ability to find the source of pervision of, and in the time and man- animal disease outbreaks. Removal of ner prescribed by, the inspector. these devices is prohibited except at the time of slaughter. If an official (c) Cleaning and disinfection: When- identification device is lost, and it is ever, upon inspection under this sec- necessary to retag an animal with a tion, an inspector determines that a new official number, every effort means of conveyance or shipping con- should be made to correlate the new of- tainer is contaminated with material ficial number with the previous official of animal origin so as to present a dan- number of the animal. ger of the spread of any communicable animal disease, he or she shall notify [55 FR 31495, Aug. 2, 1990, as amended at 59 the principal operator of the means of FR 67614, Dec. 30, 1994. Redesignated and amended at 62 FR 56012, 56017, Oct. 28, 1997; 68 conveyance or his or her agent in FR 6344, Feb. 7, 2003; 68 FR 31940, May 29, charge, of such determination and the 2003; 69 FR 64651, Nov. 8, 2004] requirements under this section. The person so notified shall cause the § 93.402 Inspection of certain aircraft cleaning and disinfection of such and other means of conveyance and shipping containers thereon; un- means of conveyance and container loading, cleaning, and disinfection under the immediate supervision of, requirements. and in the time and manner prescribed (a) Inspection: All aircraft and other by, the inspector. means of conveyance (including ship- (d) For purposes of this section, the ping containers thereon) moving into term ‘‘shipping container’’ means any the United States from any foreign re- container of a type specially adapted gion are subject to inspection without for use in transporting any article on a warrant by properly identified and the means of conveyance involved. designated inspectors to determine [55 FR 31495, Aug. 2, 1990. Redesignated and whether they are carrying any animal, amended at 62 FR 56012, 56017, Oct. 28, 1997; 68 carcass, product or article regulated or FR 6344, Feb. 7, 2003] subject to disposal under any law or regulation administered by the Sec- retary of Agriculture for prevention of

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§ 93.403 Ports designated for the im- land, Oregon; San Juan, Puerto Rico; portation of ruminants. Memphis, Tennessee (no live animals); (a) Air and ocean ports. The following El Paso, Galveston, and Houston, ports have APHIS inspection and quar- Texas; and Seattle, Spokane, and Ta- antine facilities necessary for quar- coma, Washington. antine stations and all ruminants shall (f) Designation of other ports. The Sec- be entered into the United States retary of the Treasury has approved through these stations, except as pro- the designation as quarantine stations vided in paragraphs (b), (c), (d), (e), and of the ports specified in this section. In (f) of this section; Miami, Florida; and special cases other ports may be des- Newburgh, New York. ignated as quarantine stations under (b) Canadian border ports. The fol- this section by the Administrator, with lowing land border ports are designated the concurrence of the Secretary of the as having the necessary inspection fa- Treasury. cilities for the entry of ruminants from (g) Ports and privately owned quar- Canada: Eastport, Idaho; Houlton and antine facilities. Ruminants may be im- Jackman, Maine; Detroit, Port Huron, ported into the United States at any and Sault Ste. Marie, Michigan; port specified in paragraph (a) of this Baudette, Minnesota; Opheim, Ray- section, or at any other port des- mond, and Sweetgrass, Montana; Alex- ignated as an international port or air- andria Bay, Buffalo, and Champlain, port by the Bureau of Customs and New York; Dunseith, Pembina, and Border Protection, and quarantined at Portal, North Dakota; Derby Line and an APHIS-approved privately owned Highgate Springs, Vermont; Oroville quarantine facility, provided the appli- and Sumas, Washington. cable provisions of §§ 93.401, 93.404(a), (c) Mexican border ports. The fol- 93.407, 93.408, and 93.412 are met. lowing land border ports are designated [55 FR 31495, Aug. 2, 1990, as amended at 57 as having the necessary inspection fa- FR 2010, Jan. 17, 1992; 58 FR 38283, July 16, cilities for the entry of ruminants from 1993; 60 FR 16045, Mar. 29, 1995; 60 FR 25120, Mexico: Brownsville, Hidalgo, Laredo, May 11, 1995. Redesignated and amended at 62 Eagle Pass, Del Rio, and Presidio, FR 56012, 56017, Oct. 28, 1997; 64 FR 23179, Apr. 30, 1999; 65 FR 38178, June 20, 2000; 67 FR Texas: Douglas, Naco, Nogales, Sasabe, 68022, Nov. 8, 2002; 71 FR 29773, May 24, 2006] and San Luis, Arizona; Calexico and San Ysidro, California; and Antelope § 93.404 Import permits for ruminants Wells, Columbus, and Santa Teresa, and for ruminant test specimens for New Mexico. diagnostic purposes; and reserva- (d) Special ports. Charlotte Amalie, tion fees for space at quarantine fa- St. Thomas, and Christiansted, St. cilities maintained by APHIS. Croix, in the United States Virgin Is- (a) Application for permit; reservation lands, are hereby designated as quar- required. (1) For ruminants and rumi- antine stations for the entry of nant test specimens for diagnostic ruminants from the British Virgin Is- screening purposes intended for impor- lands into the United States Virgin Is- tation from any part of the world, ex- lands for immediate slaughter. cept as otherwise provided for in (e) Limited ports. The following ports §§ 93.417, 93.422, and 93.424, the importer are designated as having inspection fa- shall first apply for and obtain from cilities for the entry of ruminants and APHIS an import permit. The applica- ruminant products such as ruminant tion shall specify the name and address test specimens which do not appear to of the importer; the species, breed, require restraint and holding inspec- number or quantity of ruminants or ru- tion facilities: Anchorage and Fair- minant test specimens to be imported; banks, Alaska; San Diego, California; the purpose of the importation; indi- Jacksonville, St. Petersburg-Clear- vidual ruminant identification, which water, and Tampa, Florida; Atlanta, includes a description of the ruminant, Georgia; Honolulu, Hawaii, Chicago, Il- name, age, markings, if any, registra- linois; New Orleans, Louisiana; Port- tion number, if any, and tattoo or land, Maine; Baltimore, Maryland; Bos- eartag; the region of origin; for cattle, ton, Massachusetts; Minneapolis, Min- the address of or other means of identi- nesota; Great Falls, Montana; Port- fying the premises of the herd of origin

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and any other premises where the cat- other circumstances which the Admin- tle resided prior to export, including istrator believes require such denial to the State or its equivalent, the munici- prevent the dissemination of any com- pality or nearest city, and the specific municable disease of livestock or poul- location of the premises, or an equiva- try into the United States. lent method, approved by the Adminis- (4)(i) The importer or importer’s trator, of identifying the location of agent shall pay or ensure payment of a the premises; the name and address of reservation fee for each lot of the exporter; the port of embarkation ruminants to be quarantined in a facil- in the foreign region; the mode of ity maintained by USDA. For transportation, route of travel, and the ruminants, the reservation fee shall be port of entry in the United States; the 100 percent of the cost of providing name and address of the quarantine fa- care, feed, and handling during quar- cility, if the ruminants are to be quarantine, as estimated by the quarantine antined at a privately owned quar- facility’s veterinarian in charge. antine facility; the proposed date of ar- (ii) At the time the importer or the rival of the ruminants or ruminant test importer’s agent requests a reservation specimens to be imported; and the of quarantine space, the importer or name of the person to whom the importer’s agent shall pay the reserva- ruminants or ruminant test specimens tion fee by check or U.S. money order will be delivered and the location of or ensure payment of the reservation the place in the United States to which fee by an irrevocable letter of credit delivery will be made from the port of from a commercial bank (the effective entry. Additional information may be date on such letter of credit shall run required in the form of certificates to 30 days after the date the ruminants concerning specific diseases to which are scheduled to be released from quar- the ruminants are susceptible, as well antine); except that anyone who issues as vaccinations or other precautionary a check to the Department for a res- treatments to which the ruminants or ervation fee which is returned because ruminant test specimens have been of insufficient funds shall be denied subjected. Notice of any such require- any further request for reservation of a ment will be given to the applicant in quarantine space until the outstanding each case. amount is paid. (2) An application for permit to im- (iii) Any reservation fee paid by port will be denied for domestic check or U.S. money order shall be ap- ruminants from any region designated plied against the expenses incurred for in § 94.1 of this chapter as a region services received by the importer or where rinderpest or foot-and-mouth importer’s agent in connection with disease exists. the quarantine for which the reserva- (3) An application for permit to im- tion was made. Any part of the reserva- port ruminants may also be denied be- tion fee which remains unused after cause of: Communicable disease condi- being applied against the expenses in- tions in the area or region of origin, or curred for services received by the im- in a region where the shipment has porter or the importer’s agent in con- been or will be held or through which nection with the quarantine for which the shipment has been or will be trans- the reservation was made, shall be reported; deficiencies in the regulatory turned to the individual who paid the programs for the control or eradication reservation fee. If the reservation fee is of animal diseases and the unavail- ensured by a letter of credit, the De- ability of veterinary services in the partment will draw against the letter above mentioned regions; the import- of credit unless payment for services er’s failure to provide satisfactory evi- received by the importer or importer’s dence concerning the origin, history, agent in connection with the quar- and health status of the ruminants; the antine is otherwise made at least 3 lack of satisfactory information nec- days prior to the expiration date of the essary to determine that the importa- letter of credit. tion will not be likely to transmit any (iv) Any reservation fee shall be for- communicable disease to livestock or feited if the importer or the importer’s poultry of the United States; or any agent fails to present for entry, within

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24 hours following the designated time of credit unless the cancellation fee is of arrival, the lot of ruminants for otherwise paid at least 3 days prior to which the reservation was made: Except the expiration date of the letter of that a reservation fee shall not be for- credit. feited if: (b) Permit. When a permit is issued, (A) Written notice of cancellation the original and two copies will be sent from the importer or the importer’s to the importer. It shall be the respon- agent is received by the office of the sibility of the importer to forward the veterinarian in charge of the quar- original permit and one copy to the 6 antine facility during regular business shipper in the region of origin, and it hours (8:00 a.m. to 4:30 p.m. Monday shall also be the responsibility of the through Friday, excluding holidays) no importer to insure that the shipper later than 15 days for ruminants prior presents the copy of the permit to the to the beginning of the time of impor- carrier and makes proper arrangements tation as specified in the import per- for the original permit to accompany mit or as arranged with the veterinarian in charge of the quarantine fa- the shipment to the specified U.S. port cility if no import permit is required of entry for presentation to the col- (the 15 days period shall not include lector of customs. Ruminants and ru- Saturdays, Sundays, or holidays), or minant test specimens for diagnostic (B) The Administrator determines screening purposes for ruminants in- that services, other than provided by tended for importation into the United carriers, necessary for the importation States for which a permit has been of the ruminants within the requested issued, will be received at the specified period are unavailable because of un- port of entry within the time pre- foreseen circumstances as determined scribed in the permit which shall not by the Administrator, (such as the exceed 14 days from the first day that closing of an airport due to inclement the permit is effective for all permits. weather or the unavailability of the re- Ruminants and ruminant test speci- served space due to the extension of an- mens for which a permit is required by other quarantine). these regulations will not be eligible (v) If the reservation fee was ensured for entry if a permit has not been by a letter of credit and the fee is to be issued; if unaccompanied by such a per- forfeited under paragraph (a)(4)(iv) of mit; if shipment is from any port other this section, the Department will draw than the one designated in the permit; against the letter of credit unless the if arrival in the United States is at any reservation fee is otherwise paid at port other than the one designated in least 3 days prior to the expiration the permit; if the ruminants or rumi- date of the letter of credit. nant test specimens offered for entry (vi) When a reservation is cancelled differ from those described in the per- in accordance with paragraph mit; if the ruminants or ruminant test (a)(4)(iv)(A) of this section and the pro- specimens are not handled as outlined visions of paragraph (a)(4)(iv)(B) of this in the application for the permit and as section do not apply, a $40.00 cancella- specified in the permit issued; or if tion fee shall be charged. If a reserva- ruminants or swine other than those tion fee was paid, the cancellation fee covered by import permits are aboard shall be deducted from any reservation the transporting carrier. fee returned to the importer or the im- (c) Wild ruminants from regions where porter’s agent. If the reservation fee foot-and-mouth disease or rinderpest ex- was ensured by a letter of credit, the ists. This paragraph (c) applies to the Department will draw the amount of importation of wild ruminants, such the cancellation fee against the letter as, but not limited to, giraffes, deer and antelopes, from regions designated 6 The addresses of USDA quarantine facili- in part 94 of this subchapter as counties may be found in telephone directories tries in which foot-and-mouth disease listing the facilities or by contacting the or rinderpest exist. Animal and Plant Health Inspection Service, Veterinary Services, National Center for Im- (1) Permits for the importation of port-Export, 4700 River Road Unit 38, River- wild ruminants will be issued only for dale, Maryland 20737–1231. importations through the Port of New

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York, and only if the animals are im- any such disease during this 1-year pe- ported for exhibition in a PEQ Zoo. A riod, its manure and other wastes need PEQ Zoo is a zoological park or other not be disposed of within the zoo after place maintained for the exhibition of the 1-year period. If, however, an live animals for recreational or edu- APHIS veterinarian determines that an cational purposes that: imported ruminant does show signs of (i) Has been approved by the Admin- any communicable disease during this istrator in accordance with paragraph 1-year period, an APHIS veterinarian (c)(2) of this section to receive and will investigate the disease and deter- maintain imported wild ruminants; and mine whether the ruminant’s manure (ii) Has entered into the agreement and other wastes may safely be dis- with APHIS set forth in paragraph posed of outside the zoo after the 1- (c)(4) of this section for the mainte- year period has ended. nance and handling of imported wild (4) Prior to the issuance of an import ruminants. permit under this section, the operator (2) Approval of a PEQ Zoo shall be on of the approved PEQ Zoo to which the the basis of an inspection, by an au- imported ruminants are to be con- thorized representative of the Depart- signed, and the importer of the ment, of the physical facilities of the ruminants, if such operator and im- establishment and its methods of oper- porter are different parties, shall exe- ation. Standards for acceptable phys- cute an agreement covering each rumi- ical facilities shall include satisfactory nant or group of ruminants for which pens, cages, or enclosures in which the the import permit is requested. The imported ruminants can be maintained agreement shall be in the following so as not to be in contact with the gen- form: eral public and free from contact with domestic livestock; natural or estab- AGREEMENT FOR THE IMPORTATION, lished drainage from the PEQ Zoo QUARANTINE AND EXHIBITION OF CER- which will avoid contamination of land TAIN WILD RUMINANTS AND WILD areas where domestic livestock are SWINE kept or with which domestic livestock llll, operator(s) of the zoological park may otherwise come in contact; provi- known as llllllllll (Name) located sion for the disposition of manure, at llllllllll (City and state), and other wastes, and dead ruminants with- llllllllll (Importer) hereby rein the PEQ Zoo; and other reasonable quest a permit for the importation of facilities considered necessary to pre- llll (Number and kinds of animals) for vent the dissemination of diseases from exhibition purposes at the said zoological the PEQ Zoo. The operator of the PEQ park, said animals originating in a region where foot-and-mouth disease or rinderpest Zoo shall have available the services of exists and being subject to restrictions under a full-time or part-time veterinarian, regulations contained in part 93, title 9, Code or a veterinarian on a retainer basis, of Federal Regulations. who shall make periodic examinations In making this request, it is understood of all animals maintained at the PEQ and agreed that: Zoo for evidence of disease; who shall 1. The animals for which an import permit make a post-mortem examination of is requested will be held in isolation at a each animal that dies; and who shall port of embarkation in the region of origin, make a prompt report of suspected approved by the Administrator as a port having facilities which are adequate for main- cases of contagious or communicable taining wild animals in isolation from all diseases to an APHIS representative or other animals and having veterinary super- the State agency responsible for live- vision by officials of the region of origin of stock disease control programs. the animals. Such animals will be held in (3) Manure and other animal wastes such isolation for not less than 60 days under must be disposed of within the PEQ the supervision of the veterinary service of Zoo park for a minimum of one year that region to determine whether the ani- following the date an imported wild ru- mals show any clinical evidence of foot-and- mouth disease, rinderpest, or other commu- minant enters the zoo. If an APHIS nicable disease that is exotic to the United veterinarian determines that an im- States or for which APHIS has an eradi- ported ruminant shows no signs of any cation or control program in 9 CFR chapter communicable disease or exposure to I, and to assure that the animals will not

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have been exposed to such a disease within chapter I, and determines that the carcass, the 60 days next before their exportation body part, or biological specimen will be from that region. moved only for scientific research or mu- 2. Shipment will be made direct from such seum display purposes. port of embarkation to the port of New York as the sole port of entry in the United llllllllllllllllllllllll States. If shipment is made by ocean vessel (Signature of importer) the animals will not be unloaded in any for- Subscribed and sworn to before me this eign port en route. If shipment is made by ll day of ll, ll. air, the animals will not be unloaded at any llllllllllllllllllllllll port or other place of landing, except at a (Title or designation) port approved by the Administrator as a port llllllllllllllllllllllll not located in a region where rinderpest or (Name of zoological park) foot-and-mouth disease exists or as a port in By lllllllllllllllllllll such a region having facilities and inspec- (Signature of officer of zoological park) tion adequate for maintaining wild animals in isolation from all other animals. llllllllllllllllllllllll 3. No ruminants or swine will be aboard the (Title of officer) transporting vehicle, vessel or aircraft, ex- Subscribed and sworn to before me this cept those for which an import permit has ll day of ll,ll been issued. llllllllllllllllllllllll 4. The animals will be quarantined for not (Title or designation) less than 30 days in the Department’s Ani- (Approved by the Office of Management and mal Import Center in Newburgh, New York. Budget under control numbers 0579–0040 and 5. Upon release from quarantine the ani- 0579–0224) mals will be delivered to the zoological park named in this agreement to become the prop- [55 FR 31495, Aug. 2, 1990, as amended at 59 erty of the park and they will not be sold, FR 28216, June 1, 1994; 59 FR 31924, June 21, exchanged or removed from the premises 1994; 59 FR 67615, Dec. 30, 1994; 62 FR 23637, without the prior consent of APHIS. If May 1, 1997. Redesignated and amended at 62 moved to another zoological park in the FR 56012, 56018, Oct. 28, 1997; 65 FR 38178, United States, the receiving zoological park June 20, 2000; 68 FR 6344, Feb. 7, 2003; 68 FR must be approved by the Administrator in 35533, June 16, 2003; 71 FR 29773, May 24, 2006] accordance with paragraph 6 of this agreement. § 93.405 Health certificate for 6. The Administrator will approve the ruminants. movement of an imported animal subject to this agreement if the Administrator deter- (a) All ruminants intended for impor- mines that the animal has spent at least one tation from any part of the world, ex- year in quarantine in a PEQ Zoo following cept as provided in §§ 93.423(c) and importation without showing clinical evi- 93.428(d), shall be accompanied by a dence of foot-and-foot mouth disease, rinder- certificate issued by a full-time sala- pest, or other communicable disease that is ried veterinary officer of the national exotic to the United States or for which government of the region of origin, or APHIS has an eradication or control program in 9 CFR chapter I, and determines issued by a veterinarian designated or that the receiving zoological park is accred- accredited by the national government ited by the American Zoo and Aquarium As- of the region of origin and endorsed by sociation (AZA), or the receiving zoological a full-time salaried veterinary officer park has facilities and procedures in place of the national government of the re- related to preventing the spread of commu- gion of origin, representing that the nicable animal diseases (including but not veterinarian issuing the certificate was limited to procedures for animal identifica- authorized to do so. The certificate tion, record keeping, and veterinary care) that are equivalent to those required for shall state: AZA accreditation. The Administrator will (1) That the ruminants have been approve the movement of a carcass, body kept in that region during the last 60 part, or biological specimen derived from an days immediately preceding the date of imported animal subject to this agreement if shipment to the United States, and the Administrator determines that the ani- that during this time the region has mal has spent at least one year in quar- been entirely free from foot-and-mouth antine in a PEQ Zoo following importation disease, rinderpest, contagious without showing clinical evidence of foot- and-foot mouth disease, rinderpest, or other pleuropneumonia, and surra; provided, communicable disease that is exotic to the however, that for wild ruminants for United States or for which APHIS has an exhibition purposes, the certificate eradication or control program in 9 CFR need specify only that the district of

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origin has been free from the listed dis- to shipment to the United States. If eases; and provided further, that for ruminants are found to be infested sheep and goats, with respect to con- with screwworm, they must be treated tagious pleuropneumonia, the certifi- until free from infestation. cate may specify only that the district (iii) At the time ruminants are load- of origin has been free from this dis- ed onto a means of conveyance for ex- ease; port, a veterinarian must treat any (2) That the ruminants are not in visible wounds on the animals with a quarantine in the region of origin; and solution of coumaphos dust at a con- (3) If the ruminants are from any re- centration of 5 percent active ingre- gion where screwworm is considered to dient. exist, the ruminants may be imported (iv) The ruminants must be accom- into the United States only if they panied to the United States by a cer- meet the requirements of paragraphs tificate signed by a full-time salaried (a)(3)(i) through (iv) of this section and veterinary official of the exporting all other applicable requirements of country. The certificate must state this part. APHIS will maintain a list of that the ruminants have been thor- regions where screwworm is considered oughly examined and found free of to exist on the APHIS Web site at screwworm and that the ruminants http://www.aphis.usda.gov/importlexport/ have been treated in accordance with animals/animalldiseaselstatus.shtml. paragraphs (a)(3)(i) and (a)(3)(iii) of Copies of the list will also be available this section. via postal mail, fax, or email upon re- (4) If the ruminants are bovines, quest to the Sanitary Trade Issues sheep, or goats from regions listed as Team, National Center for Import and BSE minimal-risk regions in Export, Veterinary Services, Animal § 94.18(a)(3) of this subchapter, the cer- and Plant Health Inspection Service, tificate must also include the name 4700 River Road Unit 38, Riverdale, and address of the importer; the spe- Maryland 20737. APHIS will add a re- cies, breed, number or quantity of gion to the list upon determining that ruminants to be imported; the purpose screwworm exists in the region based of the importation; individual rumi- on reports APHIS receives of detec- nant identification, which includes the tions of the pest from veterinary offi- official identification required under cials of the exporting country, from §§ 93.419(c) and 93.436(a)(3) and (b)(4) of the World Organization for Animal this subchapter, and any other identi- Health (OIE), or from other sources the fication present on the animal, includ- Administrator determines to be reli- ing registration number, if any; a de- able. APHIS will remove a region from scription of the ruminant, including the list after conducting an evaluation age, color, and markings, if any; region of the region in accordance with § 92.2 of origin; the address of or other means of this subchapter and finding that of identifying the premises of origin screwworm is not present in the region. and any other premises where the In the case of a region formerly not on ruminants resided immediately prior this list that is added due to a detec- to export, including the State or its tion, the region may be removed from equivalent, the municipality or nearest the list in accordance with the proce- city, or an equivalent method, ap- dures for reestablishment of a region’s proved by the Administrator, of identi- disease-free status in § 92.4 of this sub- fying the location of the premises, and chapter. the specific physical location of the (i) A veterinarian must treat the destination where the ruminants are to ruminants with ivermectin 3 to 5 days be moved after importation; the name prior to the date of export to the and address of the exporter; the port of United States according to the rec- embarkation in the foreign region; and ommended dose prescribed on the prod- the mode of transportation, route of uct’s label. travel, and port of entry in the United (ii) The ruminants must be fully ex- States. amined for screwworm by a full-time (b) Goats. (1) In addition to the state- salaried veterinary official of the ex- ments required by paragraph (a) of this porting country within 24 hours prior section, the certificate accompanying

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goats from any part of the world, ex- that has produced offspring that have cept for goats imported from Canada been affected with scrapie; for immediate slaughter, must state: (ii) That none of the female sheep in (i) That none of the goats in the herd the flock from which the sheep will be from which the goats will be imported imported has been impregnated, during is the progeny of a sire or dam that has the 5 years immediately preceding been affected with scrapie or that has shipment of the sheep to the United produced offspring that have been af- States, with germ plasm from a flock fected with scrapie; known to be infected with scrapie; (ii) That none of the female goats in (iii) That the veterinarian issuing the the herd from which the goats will be certificate has inspected the sheep in imported has been impregnated, during the flock from which the animals will the 5 years immediately preceding be imported and found the flock to be shipment of the goats to the United free of any evidence of infectious or States, with germ plasm from a herd contagious disease; and known to be infected with scrapie; (iv) That as far as it is possible for (iii) That the veterinarian issuing the the veterinarian who inspects the ani- certificate has inspected the goats in mals to determine, none of the sheep in the herd from which the animals will the flock from which the animals will be imported and found the herd to be be imported has been exposed to any infectious or contagious disease during free of any evidence of infectious or the 60 days immediately preceding contagious disease; and shipment to the United States. (iv) That as far as it is possible for (2) In addition, except for sheep im- the veterinarian who inspects the ani- ported from Canada for immediate mals to determine, none of the goats in slaughter, the certificate accom- the herd from which the animals will panying sheep intended for importation be imported has been exposed to any from any part of the world except Aus- infectious or contagious disease during tralia and New Zealand must state that the 60 days immediately preceding the sheep have not been in any flock shipment to the United States. nor had contact with sheep or goats (2) In addition, the certificate accom- that have been in any flock or herd panying goats intended for importation where scrapie has been diagnosed or from any part of the world except Aus- suspected during the 5 years imme- tralia and New Zealand must state: diately prior to shipment. (i) That the goats have not been in (3) In addition, the certificate accom- any herd nor had contact with sheep or panying sheep intended for importation goats that have been in any flock or from Australia and New Zealand must herd where scrapie has been diagnosed state that none of the female sheep in or suspected during the 5 years imme- the flock from which the sheep will be diately prior to shipment; and imported has been impregnated, during (ii) That the goats have not had any the 5 years immediately preceding contact with sheep during the 5 years shipment of the sheep to the United immediately prior to shipment; pro- States, with germ plasm from a region vided that, this statement is not re- other than Australia, New Zealand, or quired if the goats are imported in ac- the United States, or from a flock of cordance with § 93.435(a) into a herd in unknown scrapie status; provided that, the United States that participates in this statement is not required if the the Voluntary Scrapie Flock Certifi- sheep are imported in accordance with cation Program. § 93.435(a) into a flock in the United (c) Sheep. (1) In addition to the state- States that participates in the Vol- ments required by paragraph (a) of this untary Scrapie Flock Certification section, the certificate accompanying Program. sheep intended for importation from (d) If ruminants are unaccompanied any part of the world must state: by the certificate as required by para- (i) That none of the sheep in the graphs (a), (b), and (c) of this section, flock from which the sheep will be im- or if such ruminants are found upon in- ported is the progeny of a sire or dam spection at the port of entry to be af- that has been affected with scrapie or fected with a communicable disease or

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to have been exposed thereto, they had been added to the herd tested nega- shall be refused entry and shall be han- tive to any individual tests for tuber- dled or quarantined, or otherwise dis- culosis required by the Administrator; posed of as the Administrator may di- or rect. (ii) For sexually intact cattle that (Approved by the Office of Management and are from an accredited herd, the herd Budget under control numbers 0579–0040, was certified as an accredited herd for 0579–0165, and 0579–0234) tuberculosis within 1 year prior to the date of exportation to the United [55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56018, Oct. 28, 1997] States; or (iii) For sexually intact cattle that EDITORIAL NOTE: For FEDERAL REGISTER ci- are not from an accredited herd, the tations affecting § 93.405, see the List of CFR Sections Affected, which appears in the cattle originated from a herd of origin Finding Aids section of the printed volume that tested negative to a whole herd and at www.fdsys.gov. test for tuberculosis within 1 year prior to the date of exportation to the § 93.406 Diagnostic tests. United States, and the animals each (a) Tuberculosis and brucellosis tests of tested negative to one additional offi- cattle. Except as provided in paragraph cial tuberculin test conducted no more (d) of this section and in §§ 93.418, than 6 months and no less than 60 days 93.427(d), and 93.432, all cattle imported prior to the date of exportation to the from any part of the world, except for United States, and any individual cat- immediate slaughter, must be accom- tle that had been added to the herd panied by a certificate of a salaried tested negative to any individual tests veterinary officer of the national gov- for tuberculosis required by the Admin- ernment of the region of origin, or if istrator, except that the additional exported from Mexico, must be accom- test is not required if the animals are panied either by such a certificate or exported within 6 months of when the by a certificate issued by a veteri- herd of origin tested negative to a narian accredited by the National Gov- whole herd test. ernment of Mexico and endorsed by a (b) Tuberculosis and brucellosis tests of full-time salaried veterinary officer of goats. Except as provided in §§ 93.419 the National Government of Mexico, and 93.428(b), all goats offered for im- thereby representing that the veteri- portation, except for immediate narian issuing the certificate was au- slaughter, shall be accompanied by a thorized to do so, stating that: satisfactory certificate of a salaried (1) Brucellosis. The cattle have been veterinary officer of the national gov- tested for brucellosis with negative re- ernment of the region of origin, or if sults within 30 days prior to the date of exported from Mexico, shall be accom- their exportation to the United States; panied either by such a certificate or Provided, that the brucellosis test will by a certificate issued by a veteri- not be required for steers, spayed heif- narian accredited by the National Gov- ers, or any cattle less than 6 months ernment of Mexico and endorsed by a old. The certificate must give the dates full-time salaried veterinary officer of and places of testing, names of the con- the National Government of Mexico, signor and consignee, and a description thereby representing that the veteri- of the cattle, with breed, ages, and narian issuing the certificate was au- markings; and thorized to do so, showing that the (2) Tuberculosis. (i) For steers and goats have been tested for tuberculosis spayed heifers, the cattle originated and brucellosis with negative results from a herd of origin that tested nega- within 30 days of the date of their ex- tive to a whole herd test for tuber- portation. The said certificate shall culosis within 1 year prior to the date give the dates and places of testing, of exportation to the United States, method of testing, names of consignor and the animals each tested negative and consignee, and a description of the to an additional official tuberculin test goats, including breed, ages, markings, conducted within 60 days prior to the and tattoo and eartag numbers. date of exportation to the United (c) Further tests during quarantine. States, and any individual cattle that Ruminants that have been tested as

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prescribed in paragraphs (a) and (b) of ruminants except as provided in this section and that are subject to §§ 93.423(c) and 93.427(a) shall be refused quarantine at the port of entry, as pro- entry. Ruminants refused entry, unless vided in § 93.411 or § 93.427, must be re- exported within a time fixed in each tested during the last 10 days of the case by the Administrator, and in ac- quarantine period under the super- cordance with other provisions he or vision of a veterinary inspector by one she may require in each case for their or more of the methods approved by handling shall be disposed of as the Ad- the Administrator, except that cattle ministrator may direct in accordance tested in accordance with paragraph with the Animal Health Protection Act (a)(2)(i) of this section are not required (7 U.S.C. 8301 et seq.). Such portions of to be retested for tuberculosis. the transporting vessel, and of its (d) Testing exemptions. Cattle from cargo, which have been exposed to any Australia and New Zealand are exempt such ruminants or their emanations from the brucellosis testing require- shall be disinfected in such manner as ments of paragraph (a)(1) of this sec- may be considered necessary by the in- tion. spector in charge at the port of entry, to prevent the introduction or spread [55 FR 31495, Aug. 2, 1990, as amended at 57 of livestock or poultry disease, before FR 28080, June 24, 1992; 58 FR 68509, Dec. 28, 1993. Redesignated and amended at 62 FR the cargo is allowed to land. 56012, 56018, Oct. 28, 1997; 66 FR 20190, Apr. 20, [55 FR 31495, Aug. 2, 1990. Redesignated and 2001; 68 FR 35533, June 16, 2003; 69 FR 21042, amended at 62 FR 56012, 56018, Oct. 28, 1997; 68 Apr. 20, 2004] FR 6344, Feb. 7, 2003]

§ 93.407 Declaration and other docu- § 93.409 Articles accompanying ments for ruminants. ruminants. (a) The certificates, declarations, and No litter or manure, fodder or other affidavits required by the regulations aliment, nor any equipment such as in this part shall be presented by the boxes, buckets, ropes, chains, blankets, importer or his or her agent to the col- or other things used for or about lector of customs at the port of entry, ruminants governed by the regulations upon arrival of ruminants at such port, in this part, shall be landed from any for the use of the veterinary inspector conveyance except under such restric- at the port of entry. tions as the inspector in charge at the (b) For all ruminants offered for import of entry shall direct. portation, the importer or his or her agent shall first present two copies of a § 93.410 Movement from conveyances declaration which shall list the port of to quarantine station. entry, the name and address of the im- Platforms and chutes used for han- porter, the name and address of the dling imported ruminants shall be broker, the origin of the ruminants, cleaned and disinfected under APHIS the number, breed, species, and purpose supervision after being so used. The of the importation, the name of the said ruminants shall not be unneces- person to whom the ruminants will be sarily moved over any highways nor al- delivered, and the location of the place lowed to come in contact with other to which such delivery will be made. animals, but shall be transferred from the conveyance to the quarantine § 93.408 Inspection at the port of grounds in boats, cars, or vehicles ap- entry. proved by the inspector in charge at Inspection shall be made at the port the port of entry. Such cars, boats, or of entry of all ruminants imported vehicles shall be cleaned and dis- from any part of the world except as infected under APHIS supervision im- provided in §§ 93.421 and 93.426. All mediately after such use, by the carrier ruminants found to be free from com- moving the same. The railway cars so municable disease and not to have been used shall be either cars reserved for exposed thereto within 60 days prior to this exclusive use or box cars not oth- their exportation to the United States erwise employed in the transportation shall be admitted subject to the other of animals or their fresh products. provisions in this part; all other When movement of the aforesaid

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ruminants upon or across a public in writing inspection and other serv- highway is unavoidable, it shall be ices as may be required, and shall under such careful supervision and re- waive all claims against the United strictions as the inspector in charge at States and APHIS or any employee of the port of entry and the local authori- APHIS for damages which may arise ties may direct. from such services. The Administrator may prescribe reasonable rates for the § 93.411 Quarantine requirements. services provided under this paragraph. (a) Except for cattle from Central When APHIS finds it necessary to ex- America and the West Indies, and extend the usual minimum quarantine cept for ruminants from Canada and period, APHIS shall advise the oper- Mexico, all ruminants imported into ator in writing, and the operator must the United States shall be quarantined pay for such additional quarantine and for not less than 30 days counting from other services required. The operator the date of arrival at the port of entry. must pay for all services received in (b) Wild ruminants shall be subject, connection with each separate lot of during their quarantine, to such in- ruminants as specified in the compli- spections, disinfection, blood tests, or ance agreement required under para- other tests as may be required by the graph (d)(2) of this section. Administrator to determine their free- (b) Quarantine facilities maintained by dom from disease. APHIS. The importer, or his or her [61 FR 17238, Apr. 19, 1996. Redesignated at 62 agent, of ruminants subject to quar- FR 56012, Oct. 28, 1997] antine under the regulations in this part shall arrange for acceptable trans- § 93.412 Ruminant quarantine facili- portation to the quarantine facility, ties. and for the care, feed, and handling of (a) Privately owned quarantine facili- the ruminants from the time they ar- ties. The operator of a privately owned rive at the quarantine port to the time medium or minimum security quar- of release from quarantine. Such ar- antine facility subject to the regula- rangements shall be agreed to in ad- tions in this subpart shall arrange for vance by the Administrator. The im- acceptable transportation from the porter or his or her agent shall request port to the privately owned quarantine in writing such inspection and other facility and for the care, feeding, and services as may be required, and shall handling of the ruminants from the waive all claim against the United time of unloading at the port to the States and APHIS or any employee of time of release from the quarantine fa- APHIS, for damages which may arise cility. Such arrangements shall be from such services. All expenses result- agreed to in advance by the Adminis- ing therefrom or incident thereto shall trator. All expenses related to these ac- be the responsibility of the importer; tivities shall be the responsibility of APHIS assumes no responsibility with the operator. The privately owned respect thereto. The Administrator quarantine facility must be suitable for may prescribe reasonable rates for the the quarantine of the ruminants and services provided under this paragraph. must be approved by the Administrator When it is found necessary to extend prior to the issuance of any import per- the usual minimum quarantine period, mit. The facilities occupied by the the importer, or his or her agent, shall ruminants should be kept clean and be so advised in writing and shall pay sanitary to the satisfaction of the for such additional quarantine and APHIS representatives. If for any other services required. Payment for cause, the care, feeding, or handling of services received by the importer, or ruminants, or the sanitation of the fa- his or her agent, in connection with cilities is neglected, in the opinion of each separate lot of ruminants shall be the overseeing APHIS representative, made by certified check or U.S. money such services may be furnished by order prior to release of the ruminants. APHIS in the same manner as though If such payment is not made, the arrangements had been made for such ruminants may be sold in accordance services as provided by paragraph (b) of with the procedure described in this this section. The operator must request paragraph or otherwise disposed of as

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directed by the Administrator. When ticipated source(s) or origin(s) of payment is not made and the ruminants to be quarantined, as well as ruminants are to be sold to recover the expected size and frequency of ship- payment for services received, the im- ments, and a contingency plan for the porter, or his or her agent, will be noti- possible destruction and disposal of all fied by the inspector that if said ruminants capable of being held in the charges are not immediately paid or facility. satisfactory arrangements made for (A) If APHIS determines that an ap- payment, the ruminants will be sold at plication is complete and merits fur- public sale to pay the expense of care, ther consideration, the person applying feed, and handling during that period. for facility approval must agree to pay The sale will be held after the expira- the costs of all APHIS services associ- tion of the quarantine period, at such ated with APHIS’ evaluation of the ap- time and place as may be designated by plication and facility. APHIS charges the General Services Administration or for evaluation services at hourly rates other designated selling agent. The are listed in § 130.30 of this chapter. If proceeds of the sale, after deducting the facility is approved by APHIS, the the charges for care, feed, and handling operator must enter into a compliance of the ruminants and other expenses, agreement in accordance with para- including the expense of the sale, shall graph (d)(2) of this section. be held in a Special Deposit Account in (B) Requests for approval must be the United States Treasury for 6 submitted at least 120 days prior to the months from the date of sale. If not date of application for local building claimed by the importer, or his or her permits. Requests for approval will be agent, within 6 months from the date evaluated on a first-come, first-served of sale, the amount so held shall be basis. transferred from the Special Deposit (ii) Criteria for approval. Before a fa- Account to the General Fund Account cility may be built to operate as a pri- in the United States Treasury. vately owned medium or minimum se- (c) APHIS collection of payments curity quarantine facility for from the importer, or his or her agent, ruminants, it must be approved by or the operator, for service rendered APHIS. To be approved: shall be deposited so as to be available (A) APHIS must find, based on an en- for defraying the expenses involved in vironmental assessment, and based on this service. any required Federal, State, and local (d) Standards for privately owned quar- environmental permits or evaluations antine facilities for ruminants—(1) APHIS secured by the operator and copies of approval of facilities—(i) Approval proce- which are provided to APHIS, that the dures. Persons seeking APHIS approval operation of the facility will not have of a privately owned medium or min- significant environmental effects; imum security quarantine facility for (B) The facility must meet all the re- ruminants must make written applica- quirements of paragraph (d) of this section to the Administrator, c/o National tion; Center for Import and Export, Veteri- (C) The facility must meet any addi- nary Services, APHIS, 4700 River Road tional requirements that may be im- Unit 39, Riverdale, MD 20737–1231. The posed by the Administrator in each application must include the full name specific case, as specified in the com- and mailing address of the applicant; pliance agreement required under para- the location and street address of the graph (d)(2) of this section, to ensure facility for which approval is sought; that the quarantine of ruminants in blueprints of the facility; a description the facility will be adequate to enable of the financial resources available for determination of their health status, construction, operation and mainte- as well as to prevent the transmission nance of the facility; copies of all ap- of livestock diseases into, within, and proved State permits for construction from the facility; and and operation of the facility (but not (D) The Administrator must deter- local building permits), as well as cop- mine whether sufficient personnel, in- ies of all approved Federal, State, and cluding one or more APHIS veterinar- local environmental permits; the an- ians and other professional, technical,

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and support personnel, are available to graph (d)(1)(iv)(C) of this section, the serve as APHIS representatives at the Administrator will also automatically facility and provide continuous over- withdraw approval when the operator sight and other technical services to of any approved facility notifies the ensure the biological security of the fa- area veterinarian in charge for the cility, if approved. APHIS will assign State in which the facility is located, personnel to facilities requesting ap- in writing, that the facility is no proval in the order that the facilities longer in operation. 7 meet all of the criteria for approval. (C) The Administrator may deny or The Administrator has sole discretion withdraw the approval of a privately on the number of APHIS personnel to owned medium or minimum security be assigned to the facility. quarantine facility if: (iii) Maintaining approval. To main- (1) Any requirement of paragraph (d) tain APHIS approval, the operator of this section or the compliance agree- must continue to comply with all the ment is not met; or requirements of paragraph (d) of this (2) The facility has not been in use to section as well as the terms of the com- quarantine ruminants for a period of at pliance agreement executed in accord- least 1 year; or ance with paragraph (d)(2) of this sec- (3) The operator fails to remit any tion. charges for APHIS services rendered; (iv) Withdrawal or denial of approval. or Approval of a proposed privately owned (4) The operator or a person respon- medium or minimum security quar- sibly connected with the business of antine facility may be denied or ap- the facility is or has been convicted of proval of a facility already in oper- any crime under any law regarding the ation may be withdrawn at any time importation or quarantine of any ani- by the Administrator for any of the mal; or reasons provided in paragraph (5) The operator or a person respon- (d)(1)(iv)(C) of this section. sibly connected with the business of (A) Before facility approval is denied the facility is or has been convicted of or withdrawn, APHIS will inform the a crime involving fraud, bribery, extor- operator of the proposed or existing fa- tion, or any other crime involving a cility and include the reasons for the lack of integrity needed for the con- proposed action. If there is a conflict as duct of operations affecting the impor- to any material fact, APHIS will afford tation of animals; or the operator, upon request, the oppor- (6) Any other requirement under the tunity for a hearing with respect to the Animal Health Protection Act (7 U.S.C. merits or validity of such action in ac- 8301–8317) or the regulations thereunder cordance with rules of practice that are not met. APHIS adopts for the proceeding. (D) For the purposes of paragraph (B) Withdrawal of approval of an ex- (d)(1)(iv) of this section, a person is isting facility will become effective deemed to be responsibly connected pending final determination in the pro- with the business of the facility if such ceeding when the Administrator deter- person has an ownership, mortgage, or mines that such action is necessary to lease interest in the facility, or if such protect the public health, interest, or person is a partner, officer, director, safety. Such withdrawal will be effec- holder, or owner of 10 percent or more tive upon oral or written notification, of its voting stock, or an employee in a whichever is earlier, to the operator of managerial or executive capacity. the facility. In the event of oral notifi- (2) Compliance agreement. (i) A pri- cation, APHIS will give written con- vately owned medium or minimum se- firmation to the operator of the facil- curity quarantine facility must operate ity as promptly as circumstances allow. This withdrawal will continue in 7 effect pending the completion of the The name and address of the area veterinarian in charge in any State is available proceeding and any judicial review, un- from the Animal and Plant Health Inspec- less otherwise ordered by the Adminis- tion Servcie, Veterinary Services, National trator. In addition to withdrawal of ap- Center for Import and Export, 4700 River proval for the reasons provided in para- road Unit 39, Riverdale, MD 20737–1231.

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in accordance with a compliance agree- ceived in connection with each lot of ment executed by the operator or other ruminants in quarantine shall be made designated representative of the facil- prior to release of the ruminants. The ity and by the Administrator. The operator must pay for any other costs compliance agreement must be signed incurred by APHIS with respect to the by both parties before a facility may quarantine following the release of the commence operations. The compliance ruminants, based on official records, agreement must provide that: within 14 days of receipt of the bill (A) The facility must meet all appli- showing the balance due. APHIS will cable requirements of paragraph (d) of return to the operator any unobligated this section; funds deposited with APHIS, after the (B) The facility’s quarantine oper- release of the lot of ruminants from ations are subject to the strict over- the facility and termination or expira- sight of APHIS representatives; tion of the compliance agreement, or, (C) The operator agrees to be respon- if requested, credit to the operator’s sible for the cost of building the facil- account such funds to be applied to- ity; all costs associated with its main- wards payment of APHIS services at a tenance and operation; all costs associ- future date. ated with the hiring of personnel to at- (ii) Prior to the entry of each subse- tend to the ruminants, as well as to quent lot of ruminants into the me- maintain and operate the facility; all dium or minimum security facility, a costs associated with the care of quar- new compliance agreement must be ex- antined ruminants, such as feed, bed- ecuted, and a certified check or U.S. ding, medicines, inspections, testing, money order to the Administrator laboratory procedures, and necropsy must be deposited to cover the esti- examinations; all costs associated with mated costs, as determined by the Ad- the death or destruction and disposi- ministrator, of professional, technical, tion of quarantined ruminants; and all and support services to be provided by APHIS charges for the services of APHIS at the facility over the duration APHIS representatives in accordance of the quarantine. with this section and part 130 of this (3) Physical plant requirements. A pri- chapter; vately owned medium or minimum se- (D) The operator obtained, prior to curity quarantine facility must meet execution of this agreement, a finan- the following requirements as deter- cial instrument (insurance or surety mined by an APHIS inspection before bond) approved by APHIS that finan- ruminants may be admitted to it. cially guarantees the operator’s ability to cover all costs and other financial li- (i) Location. (A) The medium or min- abilities and obligations of the facility, imum security facility must be located including a worst case scenario in at a site approved by the Adminis- which all quarantined ruminants must trator, and the specific routes for the be destroyed and disposed of because of movement of ruminants from the port an animal health emergency, as deter- must be approved in advance by the mined by the Administrator. Administrator, based on consideration (E) The operator will deposit with of whether the site or routes would put the Administrator, prior to com- the animals in a position that could re- mencing quarantine operations, a cer- sult in their transmitting commu- tified check or U.S. money order to nicable livestock diseases. cover the estimated costs, as deter- (B) In the case of a medium security mined by the Administrator, of profes- facility, the facility must be located at sional, technical, and support services least one-half mile from any premises to be provided by APHIS at the facility holding livestock. In the case of a min- over the duration of the quarantine. If imum security facility, the Adminis- actual costs incurred by APHIS over trator will establish the required min- the quarantine period exceed the depos- imum distance between the facility ited amount, the operator will pay for and other premises holding livestock any additional costs incurred by on a case-by-case basis. APHIS, based on official accounting (C) If the medium or minimum secu- records. Payment for all services re- rity facility is to be located more than

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1 mile from a designated port, the oper- (A) Loading docks. The facility must ator must make arrangements for the include separate docks for animal re- imported ruminants to be held in a ceiving and releasing and for general temporary inspection facility to allow receiving and pickup, or, alternatively, for the inspection of the imported a single dock may be used for both pur- ruminants by a Federal or State veteri- poses if the dock is cleaned and dis- narian prior to the animals’ movement infected after each use in accordance to the medium or minimum security with paragraph (d)(4)(iv)(D) of this sec- facility. tion. (1) The temporary inspection facility (B) Perimeter fencing. The facility must have adequate space for Federal must be surrounded by double-security or State veterinarians to conduct ex- perimeter fencing separated by at least aminations and testing of the imported 30 feet and of sufficient height and de- ruminants. sign to prevent the entry of unauthor- (2) The examination space of the ized persons and animals from outside temporary inspection facility must be the facility and to prevent the escape equipped with appropriate animal re- of any ruminants in quarantine. straining devices for the safe inspec- (C) Means of isolation. The facility tion of ruminants. must provide pens, chutes, and other (3) The temporary inspection facility animal restraining devices, as appro- may not hold more than one lot of ani- priate, for inspection and identifica- mals at the same time. tion of each animal, as well as for seg- (4) In seeking APHIS approval of the regation, treatment, or both, of any ru- temporary inspection facility, the op- minant exhibiting signs of illness. The erator must provide APHIS with the medium or minimum security facility following information: The port of must also have lot-holding areas of suf- entry; a description of the temporary ficient size to prevent overcrowding. A inspection facility; and the anticipated medium security facility may hold source(s) of the materials to be used for more than one lot of ruminants as long the facility. as the lots are separated by physical (5) If the ruminants, upon inspection barriers such that ruminants in one lot at the temporary inspection facility, do not have physical contact with are determined to be infected with or ruminants in another lot or with their exposed to a disease that precludes excrement or discharges. A minimum their entry into the United States, the security facility may not hold more animals will be refused entry. than one lot of animals at the same Ruminants refused entry remain the time. responsibility of the operator, but sub- (D) APHIS space. The facility must ject to further handling or disposition have adequate space for APHIS rep- as directed by the Administrator in ac- resentatives to conduct examinations cordance with § 93.408 of this subpart. and draw samples for testing of (6) APHIS’ approval to build and op- ruminants in quarantine, prepare and erate a medium or minimum security package samples for mailing, and store facility outside the immediate vicinity duplicate samples and the necessary of a designated port is contingent upon equipment and supplies for each lot of APHIS’ approval of the temporary in- ruminants. The examination space spection facility at the port, as well as must be equipped with appropriate ani- approval of the routes for the move- mal restraining devices for the safe in- ment of ruminants from the port to the spection of ruminants. The facility medium or minimum security facility. must also provide a secure, lockable of- (ii) Construction. The medium or min- fice for APHIS use with enough room imum security facility must be of for a desk, chair, and filing cabinet. sound construction, in good repair, and (E) Storage. The facility must have properly designed to prevent the escape sufficient storage space for equipment of quarantined ruminants. It must and supplies used in quarantine oper- have adequate capacity to receive and ations. Storage space must include sep- hold a shipment of ruminants as a lot arate, secure storage for pesticides and on an ‘‘all-in, all-out’’ basis and must for medical and other biological sup- include the following: plies, as well as a separate storage area

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for feed and bedding, if feed and bed- in order to ensure the biological secu- ding are stored at the facility. rity of the facility. (F) Other work areas. The facility (C) Surfaces. The medium security fa- must include work areas for the repair cility must be constructed so that the of equipment and for cleaning and dis- floor surfaces with which ruminants infecting equipment used in the facil- have contact are nonslip and wear-re- ity. sistant. All floor surfaces with which (iii) Additional construction require- the ruminants, their excrement, or dis- ments for medium security facilities. For charges have contact must slope gradu- medium security facilities only, the ally to the center, where one or more following requirements must also be drains of at least 8 inches in diameter met: are located for adequate drainage, or, (A) Self-contained building. The me- alternatively, must be of slatted or dium security facility must be con- other floor design that allows for ade- structed so that the quarantine area is quate drainage. All floor and wall surfaces with which the ruminants, their located in a secure, self-contained excrement, or discharges have contact building that contains appropriate con- must be impervious to moisture and be trol measures against the spread of able to withstand frequent cleaning livestock diseases biologically trans- and disinfection without deterioration. missible by vectors. All entryways into Other ceiling and wall surfaces with the nonquarantine area of the building which the ruminants, their excrement, must be equipped with a secure and or discharges do not have contact must lockable door. While ruminants are in be able to withstand cleaning and dis- quarantine, all access to the quar- infection between shipments of antine area must be from within the ruminants. All floor and wall surfaces building. Each entryway to the quar- must be free of sharp edges that could antine area must be equipped with a cause injury to ruminants. solid self-closing door. Separate access (D) Ventilation and climate control. must be provided within the quar- The medium security facility must be antine area to each lot-holding area so constructed with a heating, ventila- that it is not necessary to move tion, and air conditioning (HVAC) sys- through one lot-holding area to gain tem capable of controlling and main- access to another lot-holding area. taining the ambient temperature, air Entryways to each lot-holding area quality, moisture, and odor at levels within the quarantine area would also that are not injurious or harmful to have to be equipped with a solid lock- the health of ruminants in quarantine. able door. Emergency exits to the out- Air supplied to lot-holding areas must side may exist in the quarantine area if not be recirculated or reused for other required by local fire ordinances. Such ventilation needs. HVAC systems for emergency exits must be constructed lot-holding areas must be separate so as to permit their opening from the from air handling systems for other inside of the facility only. operational and administrative areas of (B) Windows and other openings. Any the facility. In addition, if the facility windows or other openings in the quar- is approved to handle more than one antine area must be double-screened lot of ruminants at a time, each lot- with screening of sufficient gauge and holding area must have its own sepa- mesh to prevent the entry or exit of in- rate HVAC system that is designed to sects and other vectors of livestock dis- prevent cross-contamination between eases and to provide ventilation suffi- the separate lot-holding areas. cient to ensure the comfort and safety (E) Lighting. The medium security fa- of all ruminants in the facility. The in- cility must have adequate lighting terior and exterior screens must be sep- throughout, including in the lot-hold- arated by at least 3 inches (7.62 cm). ing areas and other areas used to exam- All screening of windows or other open- ine ruminants and conduct necropsies. ings must be easily removable for (F) Fire protection. The medium secu- cleaning, yet otherwise remain locked rity facility, including the lot-holding and secure at all times in a manner areas, must have a fire alarm and voice satisfactory to APHIS representatives communication system.

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(G) Monitoring system. The medium (A) Equipment and supplies nec- security facility must have a television essary to maintain the facility in a monitoring system or other arrange- clean and sanitary condition, including ment sufficient to provide a full view pest control equipment and supplies of the lot-holding areas. and cleaning and disinfecting equip- (H) Communication system. The me- ment with adequate capacity to dis- dium security facility must have a infect the facility and equipment. communication system between the (B) Separately maintained sanitation nonquarantine and quarantine areas of and pest control equipment and sup- the facility. plies for each lot-holding area if the fa- (I) Necropsy area. The medium secu- cility will hold more than one lot of rity facility must have an area that is ruminants at a time (applicable to me- of sufficient size to perform necropsies dium security facilities only). on ruminants and that is equipped with (C) A supply of potable water ade- adequate lighting, hot and cold run- quate to meet all watering and clean- ning water, a drain, a cabinet for storing needs, with water faucets for hoses ing instruments, a refrigerator-freezer located throughout the facility. An for storing specimens, and an autoclave emergency supply of water for to sterilize veterinary equipment. ruminants in quarantine also must be (J) Additional storage requirements. maintained. Feed storage areas in the medium secu- (D) A stock of disinfectant author- rity facility must be vermin-proof. ized in § 71.10(a)(5) of this chapter or Also, if the medium security facility otherwise approved by the Adminis- has multiple lot-holding areas, then trator that is sufficient to disinfect the separate storage space for supplies and entire facility. equipment must be provided for each (E) The capability to dispose of lot-holding area. wastes, including manure, urine, and (K) Showers. In a medium security fa- used bedding, by means of burial, incin- cility, there must be a shower at the eration, or public sewer. Other waste entrance to the quarantine area. A material must be handled in such a shower also must be located at the entrance to the necropsy area. A clothes- manner that minimizes spoilage and storage and clothes-changing area the attraction of pests and must be dis- must be provided at each end of each posed of by incineration, public sewer, shower area. There also must be one or or other preapproved manner that pre- more receptacles near each shower so vents the spread of disease. Disposal of that clothing that has been worn in a wastes must be carried out under the lot-holding area or elsewhere in the direct oversight of APHIS representa- quarantine area can be deposited in the tives. receptacle(s) prior to entering the (F) The capability to dispose of rumi- shower. nant carcasses in a manner approved (L) Restrooms. The medium security by the Administrator and under condi- facility must have permanent rest- tions that prevent the spread of disease rooms in both the nonquarantine and from the carcasses. quarantine areas of the facility. (G) For incineration to be carried out (M) Break room. The medium security at the facility, incineration equipment facility must have an area within the that is detached from other facility quarantine area for breaks and meals. structures and is capable of burning (N) Laundry area. The medium secu- wastes or carcasses as required. The in- rity facility must have an area for cineration site must include an area washing and drying clothes, linens, and sufficient for solid waste holding. In- towels. cineration may also take place at a (iv) Sanitation. To ensure that proper local site away from the facility prem- animal health and biological security ises. All incineration activities must measures are observed, a privately be carried out under the direct over- owned medium or minimum security sight of an APHIS representative. quarantine facility must provide the (H) The capability to control surface following: drainage and effluent into, within, and

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from the facility in a manner that pre- tem that prevents the entry of unau- vents the spread of disease into, with- thorized persons into the facility and in, and from the facility. If the facility prevents animals outside the facility is approved to handle more than one from having contact with ruminants in lot of ruminants at the same time, quarantine; there must be separate drainage sys- (2) If an electronic security system is tems for each lot-holding area in order used, the electronic security system to prevent cross contamination. must be coordinated through or with (v) Security. (A) A privately owned the local police so that monitoring of medium or minimum security quar- the facility is maintained whenever antine facility must provide the fol- APHIS representatives are not at the lowing security measures: facility. The electronic security sys- (1) The facility and premises must be tem must be of the ‘‘silent type’’ and kept locked and secure at all times must be triggered to ring at the moni- while the ruminants are in quarantine. toring site and, if the operator chooses, (2) The facility and premises must at the facility. The operator must pro- have signs indicating that the facility vide written instructions to the moni- is a quarantine area and no visitors are toring agency stating that the police allowed. and an APHIS representative des- (3) The operator must furnish a tele- ignated by APHIS must be notified by phone number or numbers to APHIS at the monitoring agency if the alarm is which the operator or his or her agent triggered. The operator also must sub- can be reached at all times. mit a copy of those instructions to the (4) APHIS is authorized to place seals Administrator. The operator must no- on any or all entrances and exits of the tify the designated APHIS representa- facility, when determined necessary by tive whenever a break in security oc- APHIS to ensure security, and to take curs or is suspected of occurring. all necessary steps to ensure that the (4) Operating procedures. The fol- seals are broken only in the presence of lowing procedures must be followed at an APHIS representative. If the seals a privately owned medium or minimum are broken by someone other than an security quarantine facility at all APHIS representative, it will be con- times: sidered a breach in security, and an im- (i) APHIS oversight. (A) The quar- mediate accounting of all ruminants in antine of ruminants at the facility will the facility will be made by an APHIS be subject to the strict oversight of representative. If a breach in security APHIS representatives authorized to occurs, APHIS may extend the quar- perform the services required by this antine period as long as necessary to subpart. determine that the ruminants are free (B) If, for any reason, the operator of communicable livestock diseases. fails to properly care for, feed, or han- (5) In the event that a communicable dle the quarantined ruminants as re- livestock disease is diagnosed in quar- quired in paragraph (d) of this section, antined ruminants, the Administrator or in accordance with animal health may require that the operator have the and husbandry standards provided else- facility guarded by a bonded security where in this chapter, or fails to main- company, at the expense of the oper- tain and operate the facility as pro- ator of the facility, in a manner that vided in paragraph (d) of this section, the Administrator deems necessary to APHIS representatives are authorized ensure the biological security of the fa- to furnish such neglected services at cility. the operator’s expense, as authorized in (B) A privately owned medium secu- paragraph (a) of this section. rity facility also must provide the fol- (ii) Personnel. (A) The operator must lowing security measures: provide adequate personnel to main- (1) The medium security facility and tain the facility and care for the premises must be guarded at all times ruminants in quarantine, including at- by one or more representatives of a tendants to care for and feed bonded security company, or, alter- ruminants, and other personnel as natively, the medium security facility needed to maintain, operate, and ad- must have an electronic security sys- minister the facility.

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(B) The operator must provide APHIS (3) Change protective clothing, foot- with an updated list of all personnel wear, and gloves when they become who have access to the facility. The soiled or contaminated. list must include the names, current (4) Be prohibited, if determined nec- residential addresses, and identifica- essary by the overseeing APHIS rep- tion numbers of each person, and must resentative, from having contact with be updated with any changes or addi- any susceptible animals outside the fa- tions in advance of such person having cility for at least 5 days after the last access to the quarantine facility. contact with ruminants in quarantine, (C) The operator must provide APHIS or for a longer period of time deter- with signed statements from all per- mined necessary by the overseeing sonnel having access to the facility in APHIS representative to prevent the transmission of livestock diseases. which the person agrees to comply (B) All equipment (including trac- with paragraph (d) of this section and tors) must be cleaned and disinfected applicable provisions of this part, all prior to being used in the quarantine terms of the compliance agreement, area of the facility with a disinfectant and any related instructions from that is authorized in § 71.10(a)(5) of this APHIS representatives pertaining to chapter or that is otherwise approved quarantine operations, including con- by the Administrator. The equipment tact with animals both inside and out- must remain dedicated to the facility side the facility. for the entire quarantine period. Any (iii) Authorized access. (A) Access to equipment used with quarantined the facility premises as well as inside ruminants must remain dedicated to the quarantine area will be granted that particular lot of ruminants for the only to APHIS representatives and duration of the quarantine period or be other persons specifically authorized to cleaned and disinfected before coming work at the facility. All other persons in contact with ruminants from an- are prohibited from the premises unless other lot. Prior to its use on another specifically granted access by an lot of ruminants or its removal from APHIS representative. Any visitors the quarantine area, such equipment granted access must be accompanied at must be cleaned and disinfected to the all times by an APHIS representative satisfaction of an APHIS representa- while on the premises. tive. (B) All visitors, except veterinary (C) Any vehicle, before entering or practitioners who enter the facility to leaving the quarantine area of the fa- provide emergency care, must sign an cility, must be immediately cleaned affidavit before entering the quar- and disinfected under the oversight of antine area, if determined necessary by an APHIS representative with a dis- the overseeing APHIS representative, infectant that is authorized in declaring that they will not have con- § 71.10(a)(5) of this chapter or that is otherwise approved by the Adminis- tact with any susceptible animals out- trator. side the facility for at least 5 days (D) If the facility has a single loading after contact with the ruminants in dock, the loading dock must be imme- quarantine, or for a period of time de- diately cleaned and disinfected after termined by the overseeing APHIS rep- each use under the oversight of an resentative as necessary to prevent the APHIS representative with a disinfect- transmission of communicable live- ant that is authorized in § 71.10(a)(5) of stock diseases of ruminants. this chapter or that is otherwise ap- (iv) Sanitary practices. (A) All persons proved by the Administrator. granted access to the quarantine area (E) That area of the facility in which must: a lot of ruminants had been held or had (1) Wear clean protective work cloth- access must be thoroughly cleaned and ing and footwear upon entering the disinfected under the oversight of an quarantine area. APHIS representative upon release of (2) Wear disposable gloves when han- the ruminants, with a disinfectant that dling sick animals and then wash is authorized in § 71.10(a)(5) of this hands after removing gloves. chapter or that is otherwise approved

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by the Administrator, before a new lot (B) The facility must provide suffi- of ruminants is placed in that area of cient feed and bedding for the the facility. ruminants in quarantine, and it must (F) For medium security facilities be free of vermin and not spoiled. Feed only, the following additional sanitary and bedding must originate from a re- practices also must be followed: gion that has been approved by APHIS (1) All persons granted access to the as a source for feed and bedding. quarantine area, must: (C) Breeding of ruminants or collec- (i) Shower when leaving the quar- tion of germ plasm from ruminants is antine area. prohibited during the quarantine pe- (ii) Shower before entering a lot-hold- riod unless necessary for a required im- ing area if previously exposed from ac- port testing procedure. cess to another lot-holding area. (D) Ruminants in quarantine will be (iii) Shower when leaving the ne- subjected to such tests and procedures cropsy area if a necropsy is in the proc- as directed by an APHIS representative ess of being performed or has just been to determine whether the ruminants completed, or if all or portions of the are free of communicable livestock dis- examined animal remain exposed. eases. While in quarantine, ruminants (iv) Be prohibited, unless specifically may be vaccinated only with vaccines allowed otherwise by the overseeing that have been approved by the APHIS APHIS representative, from having representative and licensed in accord- contact with any ruminants in the fa- ance with § 102.5 of this chapter. 8 Vac- cility, other than the lot or lots of cines must be administered either by ruminants to which the person is as- an APHIS veterinarian or an accred- signed or is granted access. ited veterinarian under the direct over- (2) The operator is responsible for sight of an APHIS representative. providing a sufficient supply of cloth- (E) Any death or suspected illness of ing and footwear to ensure that work- ruminants in quarantine must be re- ers and others provided access to the ported immediately to the overseeing quarantine area of the facility have clean, protective clothing and footwear APHIS representative. The affected before entering the facility. ruminants must be disposed of as the (3) The operator is responsible for the Administrator may direct or, depend- proper handling, washing, and disposal ing on the nature of the disease, must of soiled and contaminated clothing be cared for as directed by APHIS to worn in the quarantine area in a man- prevent the spread of disease. ner approved by an APHIS representa- (F) Quarantined ruminants requiring tive as adequate to preclude the trans- specialized medical attention or addi- mission of disease within and from the tional postmortem testing may be facility. At the end of each workday, transported off the quarantine site, if work clothing worn into each lot-hold- authorized by APHIS. A second quar- ing area and elsewhere in the quarantine site must be established to antine area must be collected and kept house the ruminants at the facility of in bags until the clothing is washed. destination (e.g., veterinary college Used footwear must either be left in hospital). In such cases, APHIS may the clothes changing area or cleaned extend the quarantine period until the with hot water (148 °F minimum) and results of any outstanding tests or detergent and disinfected as directed postmortems are received. by an APHIS representative. (G) Should the Administrator deter- (v) Handling of ruminants in quar- mine that an animal health emergency antine. (A) Each lot of ruminants to be exists at the facility, arrangements for quarantined must be placed in the fa- the final disposition of the infected or cility on an ‘‘all-in, all-out’’ basis. No ruminant may be taken out of a lot while the lot is in quarantine, except 8 A list of approved vaccines is available for diagnostic purposes, and no rumi- from the Center for Veterinary Biologics, nant may be added to a lot while in USDA, APHIS, VS, 510 south 17th Street6, quarantine. Suite 104, Ames, IA 50010.

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exposed lot of ruminants must be ac- § 93.413 Quarantine stations, visiting complished within 4 workdays fol- restricted; sales prohibited. lowing disease confirmation. Subse- Visitors are not permitted in the quent disposition of the ruminants quarantine enclosures during any time must occur under the direct oversight that ruminants are in quarantine unof APHIS representatives. less the APHIS representative or in- (vi) Recordkeeping. (A) The operator must maintain a current daily log, to spector in charge specifically grants record the entry and exit of all persons access under such conditions and re- entering and leaving the facility. strictions as may be imposed by the (B) The operator must retain the APHIS representative or inspector in daily log, along with any logs kept by charge. An importer (or his or her ac- APHIS and deposited with the oper- credited agent or veterinarian) may be ator, for at least 2 years following the admitted to the yards and buildings date of release of the ruminants from containing his or her quarantined quarantine and must make such logs ruminants at such intervals as may be available to APHIS representatives deemed necessary, and under such con- upon request. ditions and restrictions as may be im- (5) Environmental quality. If APHIS posed, by the APHIS representative or determines that a privately owned me- the inspector in charge of the quar- dium or minimum security quarantine antine facility or station. On the last facility does not meet applicable local, day of the quarantine period, owners, State, or Federal environmental regu- officers, or registry societies, and oth- lations, APHIS may deny or suspend ers having official business or whose approval of the facility until appro- services may be necessary in the re- priate remedial measures have been ap- moval of the ruminants may be admit- plied. ted upon written permission from the (6) Other laws. A privately owned me- APHIS representative or inspector in dium or minimum security quarantine charge. No exhibition or sale shall be facility must comply with other appli- allowed within the quarantine grounds. cable Federal laws and regulations, as well as with all applicable State and [71 FR 29779, May 24, 2006] local codes and regulations. (7) Variances. The Administrator may § 93.414 Milk from quarantined ruminants. grant variances to existing requirements relating to location, construc- Milk or cream from ruminants quar- tion, and other design features of a pri- antined under the provisions of this vately owned medium security quar- part shall not be used by any person antine facility or minimum security other than those in charge of such quarantine facility as well as to sanita- ruminants, nor be fed to any animals tion, security, operating procedures, other than those within the same en- recordkeeping, and other provisions in closure, without permission of the paragraph (d) of this section, but only APHIS representative or inspector in if the Administrator determines that charge of the quarantine station and the variance causes no detrimental im- subject to such restrictions as he or pact to the health of the ruminants or she may consider necessary to each in- to the overall biological security of the stance. No milk or cream shall be re- quarantine operations. The operator moved from the quarantine premises must submit a request for a variance to except in compliance with all State the Administrator in writing at least and local regulations. 30 days in advance of the arrival of the [55 FR 31495, Aug. 2, 1990. Redesignated at 62 ruminants to the facility. Any variance FR 56012, Oct. 28, 1997, as amended at 71 FR also must be expressly provided for in 29779, May 24, 2006] the compliance agreement. (Approved by the Office of Management and § 93.415 Manure from quarantined Budget under control number 0579–0232) ruminants. [55 FR 31495, Aug. 2, 1990. Redesignated at 62 No manure shall be removed from the FR 56012, Oct. 28, 1997, as amended at 71 FR quarantine premises until the release 29773, May 24, 2006] of the ruminants producing same.

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§ 93.416 Appearance of disease among accordance with § 93.405(a). The certifi- ruminants in quarantine. cate must state that the cattle have If any contagious disease appears been inspected and were found to be among ruminants during the quar- free from any evidence of commu- antine period special precautions shall nicable disease and that, as far as can be taken to prevent spread of the infec- be determined, they have not been ex- tion to other animals in the quarantine posed to any such disease during the station or to those outside the grounds. preceding 60 days. Cattle found un- The affected ruminants shall be disqualified upon inspection at the port of posed of as the Administrator may di- entry will be refused entry into the rect, depending upon the nature of the United States. disease. (b) Tuberculin-test certificates. (1) Cat- tle from Canada from a herd in which CANADA 8 any cattle have been determined to have tuberculosis shall not be imported § 93.417 Import permit and declaration into the United States. for ruminants. (2) Except for cattle prohibited from (a) For ruminants intended for im- importation under paragraph (b)(1) of portation from Canada, the importer this section, cattle from Canada may shall first apply for and obtain from be imported into the United States if: APHIS an import permit as provided in (i) The cattle are imported for imme- § 93.404: Provided, That an import per- diate slaughter in accordance with mit is not required for ruminants of- § 93.420; or fered for entry at a land border port (ii) The cattle are imported for move- designated in § 93.403(b) if such rumi- ment to a feedlot and then to slaughter nant is: and the certificate accompanying the (1) A wether; cattle shows, in addition to the infor- (2) A sheep or goat imported for im- mation required under § 93.405, the mediate slaughter; or breed of the animal, and: (3) A ruminant other than a sheep or (A) That the cattle are from a tuber- goat and that ruminant: culosis-free herd; or (i) Was born in Canada or the United (B) The date and place the cattle States, and has been in no region other were last tested for tuberculosis; that than Canada or the United States, or the cattle were found negative for tu- (ii) Has been legally imported into berculosis on such test; and that such Canada from some other region and untest was performed within 60 days pre- conditionally released in Canada so as ceding the arrival of the cattle at the to be eligible to move freely within port of entry; or that region without restriction of any (C) That the cattle are at least five kind and has been in Canada after such days but not more than four weeks of release for 60 days or longer. age and, therefore, exempt from the tu- (b) For all ruminants offered for im- berculosis testing requirement; or portation from Canada, the importer or (D) For a calf imported with its dam, his or her agent shall present two cop- the date and place the calf’s dam was ies of a declaration as provided in last tested for tuberculosis; that the § 93.407. dam was found negative for tuber- [55 FR 31495, Aug. 2, 1990, as amended at 60 culosis on such test; that such test was FR 13900, Mar. 15, 1995. Redesignated and performed within 60 days preceding the amended at 62 FR 56012, 56018, Oct. 28, 1997] arrival of the calf and dam at the port of entry; and that the calf was born § 93.418 Cattle from Canada. after such test was performed. (a) Health certificates. Cattle intended (c) Brucellosis test or vaccination cer- for importation from Canada must be tificates. (1) Cattle from Canada from a accompanied by a certificate issued in herd in which any cattle have been determined to have brucellosis may not 8 Importations from Canada shall be sub- be imported into the United States; ject to §§ 93.417 to 93.421, inclusive, in addi- (2) Except for cattle prohibited from tion to other sections in this part which are importation into the United States in terms applicable to such importations. under paragraph (c)(1) of this section,

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cattle 6 months of age or older from lished by the U.S. Food and Drug Ad- Canada may be imported into the ministration at 21 CFR 589.2000, and, United States if the following condi- before the animal’s arrival at the port tions are met: of entry into the United States, must (i) The cattle are imported for imme- be officially identified with unique in- diate slaughter in accordance with dividual identification that is trace- § 93.420; able to the premises of origin of the (ii) The cattle are steers; or animal. No person may alter, deface, (iii) The cattle are imported for remove, or otherwise tamper with the movement to a feedlot and then to official identification while the animal slaughter and the certificate accom- is in the United States or moving into panying the cattle shows, in addition or through the United States, except to the information required under that the identification may be removed § 93.405, the breed of the animal, and: at the time of slaughter. The animals (A) That the cattle are from a brucel- must be accompanied by the certifi- losis certified-free herd, province, or cation issued in accordance with territory; or § 93.405 that states, in addition to the (B) The date and place the cattle statements required by § 93.405, that were last tested for brucellosis; that the conditions of this paragraph have the cattle were found negative for bru- been met. Additionally, for sheep and cellosis on such test; and that such test goats imported for immediate slaugh- was performed within 30 days preceding ter, the certificate must state that the the arrival of the cattle at the port of conditions of paragraphs (d)(1) through entry; or (d)(3) of this section have been met, (C) That the female cattle under 18 and, for sheep and goats imported for months of age were vaccinated against other than immediate slaughter, the brucellosis in accordance with Cana- dian regulations; the date of such vac- certificate must state that the condi- cination; the dosage of vaccine used; tions of paragraphs (e)(1) and (e)(2) of and the age of each animal on the date this section have been met. of vaccination. (d) Sheep and goats imported for immediate slaughter. Sheep and goats im- [55 FR 31495, Aug. 2, 1990, as amended at 55 ported from Canada for immediate FR 49990, Dec. 4, 1990; 58 FR 37641, July 13, slaughter must be imported only 1993; 59 FR 28216, June 1, 1994; 61 FR 17238, Apr. 19, 1996. Redesignated and amended at 62 through a port of entry listed in FR 56012, 56018, Oct. 28, 1997; 71 FR 12997, Mar. § 93.403(b) or as provided for in § 93.403(f) 14, 2006] in a means of conveyance sealed in Canada with seals of the Canadian Gov- § 93.419 Sheep and goats from Canada. ernment, and must be moved directly (a) Sheep and goats intended for im- as a group from the port of entry to a portation from Canada must be accom- recognized slaughtering establishment panied by a certificate issued in ac- for slaughter as a group. The sheep and cordance with § 93.405. goats shall be inspected at the port of (b) If the sheep or goats are unaccom- entry and otherwise handled in accord- panied by the certificate required by ance with § 93.408. The seals on the paragraph (a) of this section, or if they means of conveyance must be broken are found upon inspection at the port only at the port of entry by the APHIS of entry to be affected with or exposed port veterinarian or at the recognized to a communicable disease, they shall slaughtering establishment by an au- be refused entry and shall be handled thorized USDA representative. If the or quarantined, or otherwise disposed seals are broken by the APHIS port of, as the Administrator may direct. veterinarian at the port of entry, the (c) Any sheep or goats imported from means of conveyance must be resealed Canada must not be pregnant, must be with seals of the U.S. Government be- less than 12 months of age when im- fore being moved to the recognized ported into the United States and when slaughtering establishment. The ship- slaughtered, must be from a flock or ment must be accompanied from the herd subject to a ruminant feed ban port of entry to the recognized slaugh- equivalent to the requirements estab- tering establishment by APHIS Form

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VS 17–33, which must include the loca- cludes the official identification re- tion of the recognized slaughtering es- quired under paragraph (c) of this sec- tablishment. Additionally, the sheep tion and any other identification and goats must meet the following con- present on the animal, including reg- ditions: istration number, if any: (1) The animals have not tested posi- (3) The seals of the national govern- tive for and are not suspect for a trans- ment of Canada must be broken only at missible spongiform encephalopathy; the port of entry by the APHIS port (2) The animals have not resided in a veterinarian or at the designated feed- flock or herd that has been diagnosed lot by an authorized USDA representa- with BSE; and tive. If the seals are broken by the (3) The animals’ movement is not re- APHIS port veterinarian at the port of stricted within Canada as a result of entry, the means of conveyance must exposure to a transmissible spongiform be resealed with seals of the U.S. Gov- encephalopathy. ernment before being moved to the des- (e) Imported for feeding. Any sheep or ignated feedlot; goats imported from Canada for feed- (4) The animals must remain at the ing at a feedlot must be imported only designated feedlot until transported to through a port of entry listed in a recognized slaughtering establish- § 93.403(b) or as provided for in § 93.403(f) ment. The animals must be moved di- in a means of conveyance sealed in the rectly to the recognized slaughtering region of origin with seals of the na- establishment in a means of convey- tional government of the region of ori- ance sealed with seals of the U.S. Gov- gin, must be moved directly as a group ernment by an accredited veterinarian, from the port of entry to a designated a State representative, or an APHIS feedlot, must not be commingled with representative. The seals must be bro- any sheep or goats that are not being ken at the recognized slaughtering es- moved directly to slaughter from the tablishment only by an authorized designated feedlot at less than 12 USDA representative; months of age, and must meet the fol- (5) The animals must be accompanied lowing conditions: to the recognized slaughtering estab- (1) The sheep and goats must be per- lishment by APHIS Form VS 1–27 or manently and humanely identified be- other documentation deemed accept- fore arrival at the port of entry with a able by the Administrator, which must distinct and legible ‘‘C’’ mark, properly identify the physical location of the applied with a freeze brand, hot iron, or recognized slaughtering establishment, other method, and easily visible on the the individual responsible for the live animal and on the carcass before movement of the animals, and the indi- skinning. The mark must be not less vidual identification of each animal, than 1 inch or more than 11⁄4 inches which includes the official identifica- high. Other means of permanent identi- tion required under paragraph (c) of fication may be used upon request if this section and any other identifica- deemed adequate by the Administrator tion present on the animal, including to humanely identify the animal in a registration number, if any; distinct and legible way as having been (6) The animals must be less than 12 imported from Canada; months of age when slaughtered; (2) The animals may be moved from (7) To be approved to receive sheep or the port of entry only to a feedlot des- goats imported for feeding, a feedlot ignated in accordance with paragraph must have signed a written agreement (e)(7) of this section and must be ac- with the Administrator stating that companied from the port of entry to the feedlot: the designated feedlot by APHIS Form (i) Will not remove official identifica- VS 17–130 or other movement docu- tion from animals unless medically mentation deemed acceptable by the necessary, in which case new official Administrator, which must identify identification will be applied and cross the physical location of the feedlot, the referenced in the records; individual responsible for the move- (ii) Will monitor all incoming im- ment of the animals, and the individual ported feeder animals to ensure that identification of each animal, which in- they have the required ‘‘C’’ brand;

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(iii) Will maintain records of the ac- § 93.420 Ruminants from Canada for quisition and disposition of all im- immediate slaughter other than bo- ported sheep and goats entering the vines, sheep, and goats. feed lot, including the official identi- The requirements for the importa- fication number and all other identi- tion of sheep and goats from Canada fying information, the age of each ani- for immediate slaughter are contained mal, the date each animal was acquired in § 93.419. The requirements for the im- and the date each animal was shipped portation of bovines from Canada for to slaughter, and the name and loca- immediate slaughter are contained in tion of the plant where each animal § 93.436. All other ruminants imported was slaughtered. For Canadian animals from Canada for immediate slaughter, that die in the feedlot, the feedlot will in addition to meeting all other appli- remove the official identification de- cable requirements of this part, must vice if affixed to the animal, or will be imported only through a port of record any other official identification entry listed in § 93.403(b) or as provided on the animal and place the official for in § 93.403(f) to a recognized slaughtering establishment for slaughter, in identification device or record of offi- conveyances that must be sealed with cial identification in a file with a seals of the U.S. Government at the record of the disposition of the carcass; port of entry. The seals may be broken (iv) Will maintain copies of the only at a recognized slaughtering es- APHIS Forms VS 17–130 and VS 1–27 or tablishment in the United States by an other movement documentation authorized USDA representative. The deemed acceptable by the Adminis- shipment must be accompanied from trator that have been issued for incom- the port of entry to the recognized ing animals and for animals moved to slaughtering establishment by APHIS slaughter and that list the official Form VS 17–33, which must include the identification of each animal; location of the recognized slaughtering (v) Will allow State and Federal ani- establishment. Such ruminants shall mal health officials access to inspect be inspected at the port of entry and its premises and animals and to review otherwise handled in accordance with inventory records and other required § 93.408. files upon request; (Approved by the Office of Management and (vi) Will keep required records for at Budget under control number 0579–0277) least 5 years; [72 FR 53377, Sept. 18, 2007] (vii) Will designate either the entire feedlot or pens within the feedlot as § 93.421 Special provisions. terminal for sheep and goats to be (a) In-bond shipments from Canada. (1) moved only directly to slaughter at Cattle, sheep, and goats from Canada less than 12 months of age, and transported in-bond through the (viii) Agrees that if inventory cannot United States for immediate export be reconciled or if animals are not shall be inspected at the border port of moved to slaughter as required the ap- entry and, when accompanied by an proval of the feedlot will be imme- import permit obtained under § 93.404 of diately withdrawn. this part and all conditions therein are observed, shall be allowed entry into (Approved by the Office of Management and the United States and shall be other- Budget under control numbers 0579–0040, wise handled as provided in paragraph 0579–0234, and 0579–0277) (b) of § 93.401. Ruminants not accom- [55 FR 31495, Aug. 2, 1990, as amended at 59 panied by a permit shall meet the re- FR 28216, June 1, 1994; 61 FR 17239, Apr. 19, quirements of this part in the same 1996. Redesignated and amended at 62 FR manner as ruminants destined for im- 56012, 56018, Oct. 28, 1997; 68 FR 6344, Feb. 7, portation into the United States, ex- 2003; 70 FR 547, Jan. 4, 2005; 70 FR 71217, Nov. cept that the Administrator may per- 28, 2005; 71 FR 12997, Mar. 14, 2006; 72 FR 53376, mit their inspection at some other Sept. 18, 2007; 73 FR 3383, Jan. 18, 2008] point when he or she finds that such action will not increase the risk that communicable diseases of livestock

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and poultry will be disseminated to the CENTRAL AMERICA AND WEST INDIES 9 livestock or poultry of the United States. § 93.422 Import permit and declaration for ruminants. (2) In-transit shipments through Can- ada. Ruminants originating in the (a) For ruminants intended for im- United States and transported directly portation from regions of Central through Canada may re-enter the America or of the West Indies, the im- United States without Canadian health porter shall first apply for and obtain or test certificates when accompanied from APHIS an import permit as pro- by copies of the United States export vided in § 93.404: Provided, That the Ad- ministrator, when he or she finds that health certificates properly issued and such action may be taken without en- endorsed in accordance with regula- dangering the livestock or poultry in- tions in part 91 of this chapter: Pro- dustry of the United States, may, upon vided, That, to qualify for entry, the request by any person, authorize the date, time, port of entry, and signature importation by such person, without of the Canadian Port Veterinarian that such application or permit, from the inspected the ruminants for entry into British Virgin Islands into the Virgin Canada shall be recorded on the United Islands of the United States, of States health certificate, or a paper ruminants consigned for immediate containing information shall be at- slaughter, and such authorization may tached to the certificate that accom- be limited to a particular shipment or panies the ruminants. In all cases it extend to all shipments under this shall be determined by the veterinary paragraph by such person during a inspector at the United States port of specified period of time. The importa- entry that the ruminants are the iden- tion of cattle from any area infested tical ruminants covered by said certifi- with cattle fever ticks is prohibited ex- cate. cept as provided in paragraph (c) of (b) Exhibition ruminants. Ruminants § 93.423. from the United States which have (b) For all ruminants offered for im- been exhibited at the Royal Agricul- portation from countries of Central tural Winter Fair at Toronto or other America or of the West Indies, the importer or his or her agent shall present publicly recognized expositions in Can- two copies of a declaration as provided ada, including racing, rodeo, circus, or in § 93.407. stage exhibitions in Canada, and have not been in that region for more than [55 FR 31495, Aug. 2, 1990. Redesignated and 90 days are eligible for return to the amended at 62 FR 56012, 56019, Oct. 28, 1997] United States without Canadian health § 93.423 Ruminants from Central or test certificates, if they are accom- America and the West Indies. panied by copies of the United States (a) Ruminants intended for importa- health certificate, issued and endorsed tion from Central America and the in accordance with the export regula- West Indies, except as provided in para- tions contained in part 91 of this chap- graph (c) of this section, must be ac- ter for entry into Canada: Provided, companied by a certificate issued in ac- That all ruminants offered for re-entry cordance with § 93.405(a) stating that upon examination by the veterinary in- the animals have been in that region at spector at the U.S. port of entry, are least 60 days immediately preceding found by the inspector to be free of the date of shipment to the United communicable diseases and exposure States; that he or she has inspected the thereto and are determined to be the ruminants on the premises of origin identical ruminants covered by said and found them free from evidence of certificates or are the natural increase any communicable disease; and that, as of such ruminants born after official test dates certified on the dam’s health 9 Importations from regions of Central certificate. America and the West Indies shall be subject to §§ 93.422 and 93.423, in addition to other [55 FR 31495, Aug. 2, 1990. Redesignated and sections in this part, which are in terms ap- amended at 62 FR 56012, 56018, Oct. 28, 1997] plicable to such importations.

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far as it has been possible to determine, such cattle are free from evi- mine, the ruminants have not been ex- dence of communicable disease and posed to any communicable disease have not been exposed to any such dis- during the preceding 60 days. If no such ease common to animals of their kind, veterinary officer is available in the re- other than splenetic, southern, or tick gion of origin, ruminants, other than fever, during the 60 days preceding sheep and goats, may be accompanied their movement to the United States by an affidavit of the owner or im- Virgin Islands. porter stating that such ruminants (d) If ruminants are unaccompanied have been in the region from which by the certificate or affidavit as re- they were directly shipped to the quired by paragraphs (a), (b), or (c) of United States for a period of at least 60 this section, or if they are found upon days immediately preceding the date of inspection at the port of entry to be af- shipment therefrom, and that during fected with a communicable disease or such period no communicable disease to have been exposed thereto, they has existed among them or among ani- shall be refused entry, except as pro- mals of their kind with which they vided in paragraph (c) of this section. have come in contact. Ruminants for Ruminants refused entry shall be han- which such affidavit is presented, un- dled or quarantined, or otherwise dis- less imported for immediate slaughter, posed of as the Administrator may di- shall be quarantined at the port of rect. entry at least seven days and during that time shall be subjected to such (Approved by the Office of Management and dipping, blood tests or other tests, as Budget under control number 0579–0040) may be required by the Administrator [55 FR 31495, Aug. 2, 1990, as amended at 61 to determine their freedom from com- FR 17239, Apr. 19, 1996. Redesignated and municable diseases. If imported for im- amended at 62 FR 56012, 56019, Oct. 28, 1997; 68 mediate slaughter, such animals shall FR 6344, Feb. 7, 2003]

be handled as provided in § 93.420. 10 (b) The certificate accompanying MEXICO sheep and goats intended for importa- § 93.424 Import permits and application from Central America and the tions for inspection of ruminants. West Indies must, in addition to the statements required by paragraph (a) (a) Forruminants intended for impor- of this section, meet all of the require- tation from Mexico, the importer shall ments of § 93.405. first apply for and obtain from APHIS (c) Cattle, which have been infested an import permit as provided in § 93.404: with or exposed to fever ticks, may be Provided, That an import permit is not imported from the British Virgin Is- required for a ruminant offered for lands into the United States Virgin Is- entry at a land border port designated lands, for immediate slaughter, only, if in § 93.403(c), if such animal is: they are free from fever ticks at the (1) A wether; or time of such importation; if they are (2) A sheep or goat imported for im- entered through one of the ports des- mediate slaughter. ignated in § 93.403(d) and are consigned (b) For ruminants intended for im- to a recognized slaughtering establish- portation into the United States from ment with facilities approved by the Mexico, the importer or his or her Administrator for holding the animals agent shall deliver to the veterinary in isolation until slaughtered, which inspector at the port of entry an appli- shall be within 14 days after the date of cation, in writing, for inspection, so entry into the United States Virgin Is- that the veterinary inspector and cus- lands; and if they are accompanied by a toms representatives may make mutu- certificate of a responsible official of ally satisfactory arrangements for the the government of the British Virgin orderly inspection of the animals. For Islands certifying that the cattle originated in and are being shipped directly 10 Importations from Mexico shall be sub- from the British Virgin Islands, that ject to §§ 93.424 to 93.429, inclusive, in addi- they are free of fever ticks, and that, tion to other sections in this part which are as far as it has been possible to deter- in terms applicable for such importations.

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all cattle, except those entering pursu- ping, and testing, as provided in this ant to the third proviso in § 93.427(d), part. and except for steers, an official record [55 FR 31495, Aug. 2, 1990, as amended at 60 of negative brucellosis test conducted FR 13898, Mar. 15, 1995. Redesignated and on the herd of origin as required in amended at 62 FR 56012, 56019, Oct. 28, 1997; 68 § 93.427(d) shall be presented to the vet- FR 6344, Feb. 7, 2003] erinary inspector at the port of entry § 93.427 Cattle from Mexico. when application is made for inspection. The veterinary inspector at the (a) Cattle and other ruminants import of entry will provide the importer ported from Mexico, except animals or his or her agent with a written being transported in bond for imme- statement assigning a date when the diate return to Mexico or animals imported for immediate slaughter, may animals may be presented for import be detained at the port of entry, and inspection. there subjected to such disinfection, [55 FR 31495, Aug. 2, 1990, as amended at 60 blood tests, other tests, and dipping as FR 13898, 13900, Mar. 15, 1995. Redesignated required in this part to determine their and amended at 56012, 56019, Oct. 28, 1997; 68 freedom from any communicable dis- FR 35534, June 16, 2003] ease or infection of such disease. The importer shall be responsible for the § 93.425 Declaration for ruminants. care, feed, and handling of the animals For all ruminants offered for impor- during the period of detention. tation from Mexico, the importer or his (b) Fever ticks. (1) Except as provided or her agent shall present two copies of in paragraph (b)(2) of this section, all a declaration as provided in § 93.407. cattle intended for importation from Mexico, for purposes other than imme- [55 FR 31495, Aug. 2, 1990. Redesignated and diate slaughter, shall be accompanied amended at 62 FR 56012, 56019, Oct. 28, 1997] by a certificate issued in accordance with § 93.405(a), and showing that the § 93.426 Inspection at port of entry. veterinarian issuing the certificate in- (a) All ruminants offered for entry spected the cattle at the time of move- from Mexico, including such ruminants ment to the port of entry and found intended for movement through the them free from any evidence of com- United States in bond for immediate municable disease and that, as far as it return to Mexico, shall be inspected at has been possible to determine, they the port of entry, and all such have not been exposed to any such dis- ruminants found to be free from com- ease, including splenetic, southern or municable disease and fever tick infes- tick fever, during the preceding 60 days tation, and not to have been exposed and, if shipped by rail or truck, the certificate shall further specify that the thereto, shall be admitted into the cattle were loaded into clean and dis- United States subject to the other ap- infected cars or trucks for transpor- plicable provisions of this part. tation direct to the port of entry. They Ruminants found to be affected with or shall also be accompanied by a certifi- to have been exposed to a commu- cate of the importer, or his or her nicable disease, or infested with fever agent supervising the shipment, stat- ticks, shall be refused entry except as ing that while en route to the port of provided in § 93.427(b)(2). Ruminants re- entry they have not been trailed or fused entry shall be handled or quar- driven through any district or area in- antined or otherwise disposed of as the fested with fever ticks. Notwith- Administrator may direct. standing such certificates, such cattle (b) Ruminants covered by paragraph shall be detained as provided in para- (a) of this section shall be imported graph (a) of this section and shall be through ports, designated in § 93.403, dipped at least once, under the super- which are equipped with facilities nec- vision of an inspector, in one of the essary for proper chute inspection, dip- permitted dips listed in § 72.13(b) of this chapter. The selection of the permitted dip to be used will be made by the port veterinarian in each case. The owner or

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his or her agent shall first execute an dip to be used will be made by the port application for inspection and dipping veterinarian in each case. If found to as provided in paragraph (b)(2)(iii) of be infested with fever ticks, the entire this section. lot of cattle shall be rejected and will (2) Cattle that have been exposed to not be again inspected for entry until splenetic, southern, or tick fever, or 10 to 14 days after they have again been that have been infested with or exposed dipped in the manner provided by para- to fever ticks, may be imported from graph (b)(2)(ii) of this section. Mexico for admission into the United (v) The conditions at the port of States, except into areas of Texas quar- entry shall be such that the subsequent antined because of said disease or tick movement of the cattle can be made infestation as specified in § 72.5 of this without exposure to fever ticks. chapter, either at one of the land bor- (c) Tuberculosis. (1) Each steer im- der ports in Texas listed in § 93.403(c) or ported into the United States from at the port of Santa Teresa, NM, pro- Mexico shall be identified with a dis- vided that the following conditions are tinct, permanent, and legible ‘‘M’’ strictly observed and complied with: mark applied with a freeze brand, hot (i) The cattle shall be accompanied iron, or other method prior to arrival by a certificate issued in accordance at a port of entry, unless the steer is with § 93.405(a), and showing that the imported for slaughter in accordance veterinarian issuing the certificate has with § 93.429. Each spayed heifer im- inspected the cattle and found them ported into the United States from free from fever ticks and any evidence Mexico shall be identified with a dis- of communicable disease, and that, as tinct, permanent, and legible ‘‘Mx’’ far as it has been possible to deter- mark applied with a freeze brand, hot mine, they have not been exposed to iron, or other method prior to arrival any such disease, except splenetic, at a port of entry, unless the spayed southern, or tick fever, during the 60 heifer is imported for slaughter in ac- days immediately preceding their cordance with § 93.429. The ‘‘M’’ or movement to the port of entry. ‘‘Mx’’ mark shall be not less than 2 (ii) The cattle shall be shown by a inches nor more than 3 inches high, certificate issued in accordance with and shall be applied to each animal’s § 93.405(a) to have been dipped in a tick- right hip, high on the tailhead (over icidal dip within 7 to 12 days before the junction of the sacral and first coc- being offered for entry. cygeal vertebrae). (iii) The importer, or his or her duly (2) Cattle from a herd or herds in authorized agent, shall first execute which one or more reactors to the tu- and deliver to an inspector at the port berculin test have been disclosed shall of entry an application for inspection not be eligible for importation until and supervised dipping wherein he or the herd to which the animals in the she shall agree to waive all claims lot belong achieve accredited herd sta- against the United States for any loss tus as defined in § 93.400, and provided or damage to the cattle occasioned by that the animals offered for entry have or resulting from dipping, or resulting met the other applicable requirements from the fact that they are later found of this section. to be still tick infested; and also for all (3) All sexually intact cattle accom- subsequent loss or damage to any other panied by the certificate required by cattle in the possession or control of § 93.405(a) will be detained at the port of such importer which may come into entry under the supervision of the port contact with the cattle so dipped. veterinarian until tested for tuber- (iv) The cattle when offered for entry culosis with negative results: Provided, shall receive a chute inspection by an That if any reactor is disclosed in any inspector. If found free from ticks they lot when so tested at the port of entry, shall be given one dipping in one of the the entire lot will be refused entry and permitted dips listed in § 72.13(b) of this the entire lot or any portion of it will chapter under the supervision of an in- not be eligible for importation until spector 7 to 14 days after the dipping the herd to which the animals in the required by paragraph (b)(2)(ii) of this lot belong achieve accredited herd sta- section. The selection of the permitted tus as defined in § 93.400, and provided

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that the animals offered for entry have antined feedlot, as defined in § 78.1 of met the other applicable requirements this chapter and thereafter handled in of this section. accordance with the provisions of (4) The importation of Holstein § 78.12 of this chapter: Provided, further, steers, Holstein spayed heifers, Hol- That if any suspect but no reactor is stein cross steers, and Holstein cross disclosed in any lot when so tested at spayed heifers from Mexico is prohib- the port of entry, any cattle found to ited. be negative to such test and any calves (d) Brucellosis. All cattle offered for under 6 months of age in such lot may importation into the United States enter without further restriction under from Mexico shall be individually iden- this paragraph (d): And provided further, tified with a numbered, blue metal That any cattle other than cattle eartag issued by the Mexican Ministry which are classified as a reactor or sus- of Agriculture and Water Resources (SARH); and except in the case of pect to a test for brucellosis may enter steers, shall be eligible for entry into the United States from Mexico without the United States only if, in addition the certificate or any test otherwise re- to complying with other applicable quired by this paragraph, if they are provisions of this part, they: individually identified with a num- (1) Are accompanied by a certificate bered, blue metal eartag issued by the issued in accordance with § 93.405(a) Mexican Ministry of Agriculture and stating: Water Resources (SARH) and are con- (i) That such cattle originated in a signed and moved to a slaughtering es- herd in which all cattle (except calves tablishment for immediate slaughter, under 6 months of age and steers) were or to a quarantined feedlot, in accord- tested for brucellosis not less than 30 ance with the first proviso in this para- days nor more than 90 days prior to the graph and otherwise comply with the date of certification and were found to applicable provisions of this part. be negative; (ii) The date and place such herd was [55 FR 31495, Aug. 2, 1990, as amended at 57 tested; and FR 2010, Jan. 17, 1992; 57 FR 28080, 28081, June (iii) That the cattle in the herd have 24, 1992; 58 FR 68509, Dec. 28, 1993; 59 FR 24886, May 13, 1994; 59 FR 65897, Dec. 22, 1994; 60 FR been isolated from all other cattle 13898, Mar. 15, 1995; 61 FR 17239, Apr. 19, 1996. from the time the herd was tested neg- Redesignated and amended at 62 FR 56012, ative for brucellosis to the date of the 56019, Oct. 28, 1997; 62 FR 64266, Dec. 5, 1997; offer of the cattle for entry into the 66 FR 20190, Apr. 20, 2001; 69 FR 9750, Mar. 2, United States; and 2004; 74 FR 5, Jan. 2, 2009] (2) Except for calves under 6 months of age, are subjected to an additional EFFECTIVE DATE NOTE: At 74 FR 5, Jan. 2, 2009, as corrected at 74 FR 22091, May 12, 2009, test for brucellosis at the port of entry § 93.427 was amended by revising paragraph and found negative to such test: Pro- (b)(2) introductory text, effective date de- vided, That if any reactor is disclosed layed indefinitely. For the convenience of in any lot when so tested at the port of the user, the revised text is set forth as fol- entry, the entire lot shall be refused lows: entry and the entire lot or any portion thereof may not be reoffered for entry § 93.427 Cattle from Mexico. until retested and recertified in accordance with paragraphs (d)(1) and (2) of * * * * * this section or any cattle found to be negative to such test and any calves (b) * * * under 6 months of age in such lot may (2) Cattle that have been exposed to splenetic, southern, or tick fever, or that have enter if consigned and moved under been infested with or exposed to fever ticks, U.S. Department of Agriculture seal may be imported from Mexico for admission and without diversion to recognized into the United States, except into areas of slaughtering establishment as defined Texas quarantined because of said disease or in § 78.1 of this chapter for immediate tick infestation as specified in § 72.5 of this slaughter, or if consigned and moved chapter, at one of the land border ports in under U.S. Department of Agriculture Texas listed in § 93.403(c), the port of Santa seal and without diversion to a quar-

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Teresa, NM, or the port of San Luis, AZ, pro- are subject to inspection at the port of vided that the following conditions are entry as provided in § 93.426. strictly observed and complied with: (Approved by the Office of Management and Budget under control number 0579–0040) * * * * * [55 FR 31495, Aug. 2, 1990, as amended at 56 § 93.428 Sheep and goats and wild FR 367, Jan. 4, 1991; 57 FR 28081, June 24, 1992; ruminants from Mexico. 61 FR 17239, Apr. 19, 1996. Redesignated and amended at 62 FR 56012, 56019, Oct. 28, 1997; 68 (a) Sheep and goats intended for im- FR 6344, Feb. 7, 2003] portation from Mexico shall be accompanied by a certificate issued in ac- § 93.429 Ruminants for immediate cordance with § 93.405 and stating, if slaughter. such sheep and goats are shipped by Ruminants, other than sheep and rail or truck, that such animals were goats, may be imported from Mexico, loaded into cleaned and disinfected subject to the applicable provisions of cars or trucks for transportation direct §§ 93.424, 93.425, 93.426, and 93.427(b)(2) to the port of entry. Notwithstanding for immediate slaughter if accom- such certificate, such sheep and goats panied by a certificate issued in accordance with § 93.405(a) and stating shall be detained as provided in that the veterinarian who issued the § 93.427(a) and shall be dipped at least certificate has inspected the animals in once in a permitted scabies dip under the herd from which the ruminants will supervision of an inspector. be imported and found them free of evi- (b) The certificate accompanying dence of communicable disease, and goats offered for importation from that, so far as it has been possible to Mexico shall, in addition to the state- determine, they have not been exposed ments required by paragraph (a) of this to any such disease common to animals section, state that such goats have of their kind during the preceding 60 been tested for tuberculosis and brucel- days, and if the ruminants are shipped losis with negative results within 30 by rail or truck, the certificate shall days preceding their being offered for further specify that the ruminants entry, and give the date and method of were loaded into cleaned and dis- testing, the name of the consignor and infected cars or trucks for transpor- of the consignee, and a description of tation directly to the port of entry. the animals including breed, ages, Such ruminants shall be moved from markings, and tattoo and eartag num- the port of entry in conveyances sealed bers. Notwithstanding such certifi- with seals of the United States Govern- cation, such goats shall be detained or ment. Sheep and goats from any part of quarantined as provided in § 93.427 and Mexico may be imported only in com- retested for brucellosis. pliance with other applicable sections in this part. (c) If sheep or goats are unaccompanied by the certificate as required by [55 FR 31495, Aug. 2, 1990, as amended at 57 paragraphs (a) and (b) of this section, FR 28081, June 24, 1992; 61 FR 17239, Apr. 19, or if they are found upon inspection or 1996. Redesignated and amended at 62 FR 56012, 56019, Oct. 28, 1997] retesting, as provided for in this part, to be affected with a communicable ADDITIONAL GENERAL PROVISIONS disease or to have been exposed there- to, they shall be refused entry and §§ 93.430–93.431 [Reserved] shall be handled or quarantined, or otherwise disposed of as the Adminis- § 93.432 Cattle from the Republic of Ireland. trator may direct. (d) Certificates will not be required (a) All cattle to be imported from the for wild ruminants, other than sheep Republic of Ireland shall be accom- and goats, originating in and shipped panied by a certificate issued or en- direct from Mexico, but such animals dorsed by a salaried veterinarian of the Republic of Ireland showing that the cattle originated from a herd which is officially certified by the Republic of

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Ireland as a brucellosis qualified for ex- stock not destined for export to the port herd and that the cattle meet the United States for at least 60 days prior requirements in § 93.432(c). to export. (b) A brucellosis qualified for export (3) The cattle were negative to the herd is a herd in which all of the cattle following tests conducted not less than have been maintained as a herd unit 60 nor more than 120 days from the date for at least two years prior to importa- of export and a second set of tests con- tion and all of the test eligible cattle ducted within 30 days of the date of ex- in the herd (i.e., cattle over 6 months of port; age, except steers and spayed heifers) (i) Plate or Tube agglutination test have been tested annually for brucel- conducted in dilutions to detect reac- losis and found negative in accordance with Republic of Ireland requirements tions at 30, 60, 120, and 240 Inter- for at least two years prior to importa- national Units per milliliter (IU/ml); tion. The most recent negative herd (ii) Brucellosis card test (Rose Ben- test must have been conducted within gal test); 12 months of the date of importation. (iii) Complement Fixation (CF) test In addition: conducted in dilutions to detect (1) Such herd unit may include cattle prozone reactions, when present. which were born and raised within such (4) Cattle are eligible for entry only herd unit during the two year period, if classified as negative at 30 IU to the or cattle which were moved directly to Plate or Tube agglutination test, nega- the herd from another herd unit of like tive to the brucellosis card test and status; or negative to the CF test as performed (2) Such herd unit may include other and interpreted by standard methods cattle (except brucellosis reactors, sus- at the Republic of Ireland Brucellosis pects and animals listed in Diagnostic Laboratory. Any animal ex- § 93.432(c)(1)) if: hibiting a prozone serological reaction (i) Such other cattle have been tested is ineligible for export to the United for brucellosis and found negative States. within 30 days prior to entry into the (5) Cattle showing a serological titer herd unit and all eligible cattle in the herd unit have been tested for brucel- more than 60 IU to the Plate or Tube losis and found negative not less than agglutination test, or a reaction to the 90 days following the date when the Brucellosis card test (Rose Bengal) or last of the other cattle had been added CF test that would be interpreted to be to the herd unit; or an infected animal (reactor) under the (ii) All eligible cattle in the herd unit Republic of Ireland brucellosis control have been tested negative for brucel- program. Animals from that herd of or- losis no less than 180 days nor more igin and all other cattle having the op- than 12 months (365 days) following the portunity for contact with the reactor date when the last of the other cattle animal shall not be eligible for export had been added to the herd unit. to the United States. Brucellosis bac- (c) The certificate accompanying cat- teriologically positive animals, if tle offered for importation from the known, regardless of serologic reac- Republic of Ireland shall show that the tions, are not eligible for importation cattle are from a brucellosis qualified nor are any animals in contact with for export herd and that they meet the such animals. following requirements: (6) The cattle were moved directly to (1) The cattle to be exported were not the port of export from the isolation born to or nursed by brucellosis reac- facility without contact with any other tors and they were not born in a herd cattle which are not qualified for ex- at the time the herd was under quar- port to the United States. antine due to brucella infection. (2) The cattle were placed in an isola- (d) The certificate accompanying the tion facility approved by a full-time, cattle offered for importation must salaried, Government of Ireland veteri- also show the dates and places of test- nary official, on separate premises a ing, names of the consignor and con- minimum of 500 yards from other live- signee, and descriptions of the cattle,

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including breed, ages, markings, and Scrapie Flock Certification Program tattoo and eartag numbers. identification number of the receiving flock or herd as part of the application [55 FR 31495, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56019, Oct. 28, 1997] for an import permit. (d) Sheep and goats may be imported §§ 93.433–93.434 [Reserved] under paragraph (a)(1) of this section only if they come from a flock or herd § 93.435 Sheep and goats. in the region of origin that participates (a) Except as provided in paragraph in a program determined by the Ad- (b) of this section, all sheep and goats ministrator to be equivalent to the imported into the United States must Voluntary Scrapie Flock Certification be placed in a flock or herd in the Program, and the flock or herd has United States that participates in the been determined by the Administrator Voluntary Scrapie Flock Certification to be at a level equivalent to ‘‘Cer- Program (see 9 CFR part 54, subpart B) tified’’ in the Voluntary Scrapie Flock and: Certification Program. (1) The flock or herd qualifies as a (e) Sheep and goats may be imported ‘‘Certified’’ flock or herd; or under paragraph (a)(2) of this section (2) The flock or herd owner has only if they are placed in a Certifiable agreed, in writing, to maintain the Class C flock or herd participating in flock or herd in compliance with all re- the Voluntary Scrapie Flock Certifi- quirements of the Voluntary Scrapie cation Program; except, that if the Flock Certification Program until the sheep and goats come from a flock or flock or herd qualifies as a ‘‘Certified’’ herd in the region of origin that par- flock or herd. ticipates in a program determined by (b) The following sheep and goats are the Administrator to be equivalent to not subject to paragraph (a) of this sec- the Voluntary Scrapie Flock Certifi- tion: cation Program, then the sheep and (1) Goats intended for importation goats may be placed in a herd or flock from Australia, Canada, or New Zea- in the United States which would be land; classified at a level equivalent to or (2) Goats intended for importation lower (i.e., at a greater risk) than the from any region other than Australia, certification level, as determined by Canada, or New Zealand, provided that the Administrator, of the flock or herd such goats have not had any contact from which the sheep or goats are to be with sheep during the 5 years imme- imported. diately prior to shipment, in accord- (f) Sheep and goats imported under ance with § 93.405(b)(2)(ii); paragraph (a)(2) of this section must be (3) Sheep intended for importation monitored for scrapie disease until the from Australia, Canada, or New Zea- flock or herd qualifies as a ‘‘Certified’’ land, provided that none of the female flock or herd. sheep in the flock from which the sheep (g) Except for imported sheep and will be imported has been impregnated, goats placed in Certifiable Class C during the 5 years immediately pre- flocks or herds, the certificate accom- ceding shipment of the sheep to the panying sheep or goats imported under United States, with germ plasm from a paragraph (a) of this section must con- region other than Australia, Canada, tain the following statement: ‘‘The ani- New Zealand, or the United States, in mals identified on this certificate have accordance with § 93.405(c)(3); been monitored by a salaried veteri- (4) Wethers; nary officer of [name of country of ori- (5) Sheep or goats imported for im- gin], for [number of months], in the same mediate slaughter; and source flock or herd which had been de- (6) Wild sheep or goats imported for termined by the Administrator, exhibition purposes to an approved zoo- APHIS, prior to the exportation of logical park in accordance with these animals to the United States, to § 93.404(c). be equivalent to [certification level] of (c) Sheep or goats may be imported the Voluntary Scrapie Flock Certifi- under paragraph (a) of this section only cation Program authorized under 9 if the importer provides the Voluntary CFR part 54, subpart B.’’

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(1) The Administrator will determine, § 93.436 Ruminants from regions of based upon information supplied by the minimal risk for BSE. importer, whether the flock or herd The importation of ruminants from from which the animals are to be im- regions listed in § 94.18(a)(3) of this sub- ported participates in a program in the chapter is prohibited, unless the condi- country of origin that is equivalent to tions of this section and any other ap- the Voluntary Scrapie Flock Certifi- plicable conditions of this part are cation Program, and if so, at what met. Once the ruminants are imported, level the source flock or herd should be if they do not meet the conditions of classified. this section, they must be disposed of (2) In order for the Administrator to as the Administrator may direct. make a determination, the importer (a) Bovines for immediate slaughter. must supply the following information Bovines from a region listed in with the application for an import per- § 94.18(a)(3) of this subchapter may be mit no less than 1 month prior to the imported for immediate slaughter anticipated date of importation: under the following conditions: (i) The name, title, and address of a (1) The bovines must have been born knowledgeable official in the veteri- on or after a date determined by nary services of the region of origin; APHIS to be the date of effective en- (ii) The details of scrapie control pro- forcement of a ruminant-to-ruminant grams in the region of origin, including feed ban in the region of export. For information on disease surveillance bovines imported from Canada, that and border control activities and the date is March 1, 1999. length of time such activities have (2) Before the animal’s arrival at the been in effect; port of entry into the United States, (iii) Any available information con- each bovine imported into the United cerning additions, within the 5 years States from a BSE minimal-risk region immediately preceding shipment to the must be officially identified with United States, to the flock or herd unique individual identification that is from which the sheep and goats will be traceable to the premises of origin of imported; the animal. No person may alter, de- (iv) Any available data concerning face, remove, or otherwise tamper with disease incidence, within the 5 years the official identification while the immediately preceding shipment to the animal is in the United States or mov- United States, in the flock or herd ing into or through the United States, from which the sheep or goats are to be except that the identification may be imported, including, but not limited to, removed at slaughter; the results of diagnostic tests, espe- (3) The bovines must be accompanied cially histopathology tests, conducted by a certificate issued in accordance on any animals in the flock or herd; with § 93.405 that states, in addition to (v) Information concerning the the statements required by § 93.405, health, within the 5 years immediately that the conditions of paragraphs (a)(1) preceding shipment to the United and (a)(2) of this section have been States, of other ruminants, flocks, and met; herds with which the imported sheep (4) The bovines must be imported and goats, and with which animals in only through a port of entry listed in the sheep or goats’ flock or herd might § 93.403(b) or as provided for in have had physical contact, and a de- § 93.403(f). The bovines shall be inscription of the type and frequency of spected at the port of entry and other- such physical contact; and wise handled in accordance with (vi) Any other information requested § 93.408; (5) The bovines must be moved di- by the Administrator in specific cases rectly from the port of entry to a rec- as needed to make a determination. ognized slaughtering establishment. (Approved by the Office of Management and Bovines imported from Canada must be Budget under control numbers 0579–0040 and moved to the slaughtering establish- 0579–0101) ment in conveyances that are sealed [61 FR 17240, Apr. 19, 1996. Redesignated and with seals of the U.S. Government at amended at 62 FR 56012, 56019, Oct. 28, 1997] the port of entry. The seals may be

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broken only at the recognized slaugh- face, remove, or otherwise tamper with tering establishment by an authorized the official identification while the USDA representative; and animal is in the United States or mov- (6) The bovines must be accompanied ing into or through the United States, from the port of entry to the recog- except that the identification may be nized slaughtering establishment by removed at slaughter; APHIS Form VS 17–33. (4) The bovines must be accompanied (b) Bovines for other than immediate by a certificate issued in accordance slaughter. Bovines from a region listed with § 93.405 that states, in addition to in § 94.18(a)(3) of this subchapter may the statements required by § 93.405, be imported for other than immediate that the conditions of paragraphs (a)(1) slaughter under the following condi- and (a)(2) of this section have been tions: met; and (1) The bovines must have been born (5) The bovines must be imported on or after a date determined by only through a port of entry listed in APHIS to be the date of effective en- § 93.403(b) or as provided for in forcement of a ruminant-to-ruminant § 93.403(f). feed ban in the region of export. For (c) Sheep and goats for immediate bovines imported from Canada, that slaughter. Sheep and goats from a re- date is March 1, 1999. gion listed in § 94.18(a)(3) of this sub- (2) The bovines must be permanently chapter may be imported for imme- and humanely identified before arrival diate slaughter under the conditions at the port of entry with a distinct and set forth in this subpart for such sheep legible mark identifying the exporting and goats. The conditions for the im- country. Acceptable means of perma- portation of sheep and goats from Can- nent identification include the fol- ada for immediate slaughter are set lowing: forth in §§ 93.405 and 93.419. (i) A mark properly applied with a (d) Sheep and goats for feeding. Sheep freeze brand, hot iron, or other method, and goats from a region listed in and easily visible on the live animal § 94.18(a)(3) of this subchapter may be and on the carcass before skinning. imported for other than immediate Such a mark must be not less than 2 slaughter under the conditions set inches nor more than 3 inches high, forth in this subpart for such sheep and and must be applied to each animal’s goats. The conditions for the importa- right hip, high on the tail-head (over tion of sheep and goats from Canada the junction of the sacral and first for other than immediate slaughter are set forth in §§ 93.405 and 93.419. cocygeal vertebrae). Bovines exported (e) Cervids. There are no BSE-related from Canada so marked must be restrictions on the importation of marked with ‘‘C N’’; L cervids from a region listed in (ii) A tattoo with letters identifying § 94.18(a)(3) of this subchapter. the exporting country must be applied (f) Camelids. There are no BSE-re- to the inside of one ear of the animal. lated restrictions on the importation of For bovines exported from Canada, the camelids from a region listed in tattoo must read ‘‘CAN’’; § 94.18(a)(3) of this subchapter. (iii) Other means of permanent identification upon request if deemed ade- (Approved by the Office of Management and quate by the Administrator to hu- Budget under control number 0579–0234) manely identify the animal in a dis- [70 FR 548, Jan. 4, 2005, as amended at 70 FR tinct and legible way as having been 71217, Nov. 28, 2005; 71 FR 12997, Mar. 14, 2006; imported from the BSE minimal-risk 72 FR 53377, Sept. 18, 2007; 73 FR 3384, Jan. 18, exporting region. 2008] (3) Before the animal’s arrival at the port of entry into the United States, Subpart E—Swine each bovine imported into the United States from a BSE minimal-risk region § 93.500 Definitions. must be officially identified with Wherever in this subpart the fol- unique individual identification that is lowing terms are used, unless the con- traceable to the premises of origin of text otherwise requires, they shall be the animal. No person may alter, de- construed, respectively, to mean:

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Accredited veterinarian. A veteri- cate of inspection from a recognized narian approved by the Administrator brand inspection authority. in accordance with the provisions of Port veterinarian. A veterinarian em- part 161 of this title to perform func- ployed by the Animal and Plant Health tions specified in parts 1, 2, 3, and 11 of Inspection Service to perform duties subchapter A, and subchapters B, C, required under this part at a port of and D of this chapter, and to perform entry. functions required by cooperative Recognized slaughtering establishment. 2 state-federal disease control and eradi- An establishment where slaughtering cation programs. operations are regularly carried on Administrator. The Administrator of under federal or state inspection and the Animal and Plant Health Inspec- which has been approved by the Animal tion Service or any other employee of and Plant Health Inspection Service to the Animal and Plant Health Inspec- receive animals for slaughter under tion Service, United States Depart- this part. ment of Agriculture, to whom author- Region. Any defined geographic land ity has been or may be delegated to act area identifiable by geological, polit- in the Administrator’s stead. ical, or surveyed boundaries. A region Animal and Plant Health Inspection may consist of any of the following: Service. The Animal and Plant Health (1) A national entity (country); Inspection Service of the United States (2) Part of a national entity (zone, Department of Agriculture (APHIS or county, department, municipality, par- Service). ish, Province, State, etc.); Animals. Cattle, sheep, goats, other (3) Parts of several national entities ruminants, swine, horses, asses, mules, combined into an area; or zebras, dogs, and poultry. (4) A group of national entities (coun- APHIS representative. A veterinarian tries) combined into a single area. or other individual employed by the Ruminants. All animals which chew Animal and Plant Health Inspection the cud, such as cattle, buffaloes, Service, United States Department of sheep, goats, deer, antelopes, camels, Agriculture, who is authorized to per- llamas and giraffes. form the services required by this part. Swine. The domestic hog and all vari- Communicable disease. Any con- eties of wild hogs. tagious, infectious, or communicable United States. All of the States of the disease of domestic livestock, poultry or other animals. United States, the District of Colum- Department. The United States De- bia, Guam, Northern Mariana Islands, partment of Agriculture (USDA). Puerto Rico, the Virgin Islands of the Immediate slaughter. Consignment di- United States, and all other Territories rectly from the port of entry to a rec- and Possessions of the United States. ognized slaughtering establishment 1 Veterinary Services. The Veterinary and slaughter thereat within two Services unit of the Department. weeksfrom the date of entry. Zoological park. A professionally oper- Inspector. An employee of the Animal ated zoo, park, garden or other place, and Plant Health Inspection Service maintained under the constant surveil- authorized to perform duties required lance of a Doctor of Veterinary Medi- under this subpart. cine, for the exhibition of live animals, Official identification device or method. pigeons or birds, for the purpose of pub- A means of officially identifying an lic recreation or education. animal or group of animals using de- [55 FR 31495, Aug. 2, 1990. Redesignated and vices or methods approved by the Ad- amended at 62 FR 56012, 56020, Oct. 28, 1997; 69 ministrator, including, but not limited FR 64651, Nov. 8, 2004; 71 FR 29070, May 19, to, official tags, tattoos, and registered 2006; 72 FR 67232, Nov. 28, 2007; 76 FR 70039, brands when accompanied by a certifi- Nov. 10, 2011; 77 FR 1391, Jan. 10, 2012]

1 The name of recognized slaughtering es- 2 The name of recognized slaughtering establishments approved under this part may tablishments approved under this part may be obtained from the Area Veterinarian in be obtained from the Area Veterinarian in Charge, Veterinary Services, for the State of Charge, Veterinary Services, for the State of destination of the shipment. destination of the shipment.

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§ 93.501 General prohibitions; excep- livestock or poultry disease, and they tions. are maintained there under continuous (a) No swine or product subject to the confinement until loaded aboard a provisions of this part shall be brought means of conveyance for transpor- into the United States except in ac- tation from the United States and are cordance with the regulations in this maintained under continuous confine- part and part 94 of this subchapter;3 ment aboard such means of conveyance nor shall any such swine or product be until it leaves the United States; the handled or moved after physical entry import permit will specify any addi- into the United States before final re- tional conditions necessary to assure lease from quarantine or any other that the transit of the swine through form of governmental detention except the United States can be made without in compliance with such regulations; endangering the livestock or poultry of Provided, That, the Administrator may the United States, and that Depart- upon request in specific cases permit ment inspectors may inspect the swine swine or products to be brought into or on board such means of conveyance or through the United States under such in such holding facility to ascertain conditions as he or she may prescribe, whether the requirements of this para- when he or she determines in the spe- graph are met, and dispose of them in cific case that such action will not en- accordance with the Animal Health danger the livestock or poultry of the Protection Act (7 U.S.C. 8301 et seq.) if United States. such conditions are not met; and (b) Except for swine prohibited entry, (2) The carrier or its agent executes the provisions in this part 93 relating and furnishes to the collector of Cus- to swine shall not apply to healthy toms at the first port of arrival a dec- swine in transit through the United laration stating that the swine will be States if they are not known to be in- retained aboard such means of convey- fected with or exposed, within 60 days ance or in an approved holding facility preceding the date of export from the during transshipment as required by region of origin, to communicable dis- this paragraph. eases of such swine, if an import per- (3) Provisions for the approval of fa- mit 4 has been obtained under § 93.504 of cilities required in this paragraph are: this Chapter and all conditions therein are observed; and if such swine are han- (i) They must be sufficiently isolated dled as follows: to prevent direct or indirect contact (1)(i) They are maintained under con- with all other animals and birds while tinuous confinement in transit through in the United States. the United States aboard an aircraft, (ii) They must be so constructed that ocean vessel, or other means of convey- they provide adequate protection ance; or against environmental conditions and (ii) They are unloaded, in the course can be adequately cleaned, washed and of such transit, into a swine holding fa- disinfected. cility which is provided by the carrier (iii) They must provide for disposal of or its agent and has been approved 5 in swine carcasses, manure, bedding, advance by the Administrator in ac- waste and any related shipping mate- cordance with paragraph (d)(3) of this rials in a manner that will prevent dis- section as adequate to prevent the semination of disease. spread within the United States of any (iv) They must have provisions for adequate sources of feed and water and 3 Importations of certain animals from var- for attendants for the care and feeding ious countries are absolutely prohibited of swine in the facility. under part 94 because of specified diseases. (v) They must comply with addi- 4 Such permit may be obtained from the tional requirements as may be imposed Animal and Plant Health Inspection Service, by the Administrator if deemed appli- Veterinary Services, National Center for Im- cable for a particular shipment. port-Export, 4700 River Road Unit 38, River- dale, Maryland 20737–1231. Requests for ap- (vi) They must also comply with all proval of such facilities should also be made applicable local, State and Federal re- to the Administrator. quirements for environmental quality 5 See footnote 4 to subpart E. and with the provisions of the Animal

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Welfare Regulations in chapter I of this of the means of conveyance and his or title, as applicable. her agent in charge of the means of (c) Removal and loss of official identi- conveyance shall comply with any such fication devices. Official identification requirement under the immediate su- devices are intended to provide perma- pervision of, and in the time and man- nent identification of livestock and to ner prescribed by, the inspector. ensure the ability to find the source of (c) Cleaning and disinfection: When- animal disease outbreaks. Removal of ever, upon inspection under this sec- these devices is prohibited except at tion, an inspector determines that a the time of slaughter. If an official means of conveyance or shipping con- identification device is lost and it is tainer is contaminated with material necessary to retag an animal with a of animal origin so as to present a dan- new official number, every effort ger of the spread of any communicable should be made to correlate the new of- animal disease, he or she shall notify ficial number with the previous official the principal operator of the means of number of the animal. conveyance or his or her agent in charge, of such determination and the [55 FR 31495, Aug. 2, 1990, as amended at 59 requirements under this section. The FR 67615, Dec. 30, 1994. Redesignated and person so notified shall cause the amended at 62 FR 56012, 56020, Oct. 28, 1997; 68 FR 6344, Feb. 7, 2003; 69 FR 64651, Nov. 8, 2004] cleaning and disinfection of such means of conveyance and container § 93.502 Inspection of certain aircraft under the immediate supervision of, and other means of conveyance and and in the time and manner prescribed shipping containers thereon; un- by, the inspector. loading, cleaning, and disinfection (d) For purposes of this section, the requirements. term ‘‘shipping container’’ means any (a) Inspection: All aircraft and other container of a type specially adapted means of conveyance (including ship- for use in transporting any article on ping containers thereon) moving into the means of conveyance involved. the United States from any foreign re- [55 FR 31495, Aug. 2, 1990. Redesignated and gion are subject to inspection without amended at 62 FR 56012, 56020, Oct. 28, 1997; 68 a warrant by properly identified and FR 6344, Feb. 7, 2003] designated inspectors to determine whether they are carrying any animal, § 93.503 Ports designated for the im- carcass, product or article regulated or portation of swine. subject to disposal under any law or (a) Air and ocean ports. The following regulation administered by the Sec- ports have APHIS inspection and quar- retary of Agriculture for prevention of antine facilities necessary for quar- the introduction or dissemination of antine stations and all swine shall be any communicable animal disease. entered into the United States through (b) Unloading requirements: Whenever these stations, except as provided in in the course of any such inspection at paragraphs (b), (c), (d), (e), and (f) of any port in the United States the in- this section: Los Angeles, California; spector has reason to believe that the Miami, Florida; and Newburgh, New means of conveyance or container is York. contaminated with material of animal (b) Canadian border ports. The fol- (including poultry) origin, such as, but lowing land border ports are designated not limited to, meat, organs, glands, as having the necessary inspection fa- extracts, secretions, fat, bones, blood, cilities for the entry of swine from lymph, urine, or manure, so as to Canada: Eastport, Idaho; Houlton and present a danger of the spread of any Jackman, Maine; Detroit, Port Huron, communicable animal disease, the in- and Sault Ste. Marie, Michigan; spector may require the unloading of Baudette, Minnesota; Opheim, Ray- the means of conveyance and the mond, and Sweetgrass, Montana; Alex- emptying of the container if he or she andria Bay, Buffalo, and Champlain, deems it necessary to enable him or New York; Dunseith, Pembina, and her to determine whether the means of Portal, North Dakota; Derby Line and conveyance or container is in fact so Highgate Springs, Vermont; Oroville contaminated. The principal operator and Sumas, Washington.

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(c) Mexican border ports. The fol- § 93.504 Import permits for swine and lowing land border ports are designated for swine specimens for diagnostic as having the necessary inspection fa- purposes; and reservation fees for cilities for the entry of swine from space at quarantine facilities main- Mexico: Brownsville, Hidalgo, Laredo, tained by APHIS. Eagle Pass, Del Rio, Presidio, and El (a) Application for permit; reservation Paso, Texas; Douglas, Naco, Nogales, required. (1) For swine and swine test Sasabe, and San Luis, Arizona; specimens for diagnostic screening pur- Calexico and San Ysidro, California; poses, intended for importation from and Antelope Wells, and Columbus, any part of the world, except as other- New Mexico. wise provided for in §§ 93.516 and 93.520, (d) Special ports. Charlotte Amalie, the importer shall first apply for and St. Thomas, and Christiansted, St. obtain from APHIS an import permit. Croix, in the United States Virgin Is- The application shall specify the name lands, are hereby designated as quar- and address of the importer; the spe- antine stations for the entry of swine cies, breed, number or quantity of from the British Virgin Islands into swine or swine test specimens to be im- the United States Virgin Islands for ported; the purpose of the importation; immediate slaughter. individual swine identification which (e) Limited ports. The following ports includes a description of the swine, are designated as having inspection fa- name, age, markings, if any, registra- cilities for the entry of swine and swine tion number, if any, and tattoo or products such as swine test specimens eartag; the region of origin; the name which do not appear to require re- and address of the exporter; the port of straint and holding inspection facili- embarkation in the foreign region; the ties: Anchorage and Fairbanks, Alaska; mode of transportation, route of travel, San Diego, California; Jacksonville, St. and the port of entry in the United Petersburg-Clearwater, and Tampa, States; the proposed date of arrival of Florida; Atlanta, Georgia; Honolulu, the swine or swine test specimens to be Hawaii; Chicago, Illinois; New Orleans, imported; and the name of the person Louisiana; Portland, Maine; Baltimore, to whom the swine or swine test speci- Maryland; Boston, Massachusetts; Min- mens will be delivered and the location neapolis, Minnesota; Great Falls, Mon- of the place in the United States to tana; Portland, Oregon; San Juan, which delivery will be made from the Puerto Rico; Memphis, Tennessee (no port of entry. Additional information live animals); Galveston and Houston, may be required in the form of certifi- Texas; and Seattle, Spokane, and Ta- cates concerning specific diseases to coma, Washington. which the swine are susceptible, as well as vaccinations or other precautionary (f) Designation of other ports. The Sec- treatments to which the swine or swine retary of the Treasury has approved test specimens have been subjected. the designation as quarantine stations Notice of any such requirements will of the ports specified in this section. In be given to the applicant in each case. special cases other ports may be des- (2) An application for permit to im- ignated as quarantine stations under port will be denied for domestic swine this section by the Administrator, with from any region designated in § 94.1 of the concurrence of the Secretary of the this chapter as a region where rinder- Treasury. pest or foot-and-mouth disease exists. [55 FR 31495, Aug. 2, 1990, as amended at 58 (3) An application for permit to im- FR 38283, July 16, 1993; 60 FR 16045, Mar. 29, port swine may also be denied because 1995; 60 FR 25120, May 11, 1995. Redesignated of: Communicable disease conditions in at 62 FR 56012, Oct. 28, 1997, as amended at 64 the area or region of origin, or in a re- FR 23179, Apr. 30, 1999; 65 FR 38178, June 20, gion where the shipment has been or 2000; 67 FR 68022, Nov. 8, 2002] will be held or through which the shipment has been or will be transported; deficiencies in the regulatory programs for the control or eradication of animal

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diseases and the unavailability of vet- partment will draw against the letter erinary services in the above men- of credit unless payment for services tioned regions; the importer’s failure received by the importer or importer’s to provide satisfactory evidence con- agent in connection with the quar- cerning the origin, history, and health antine is otherwise made at least 3 status of the swine; the lack of satis- days prior to the expiration date of the factory information necessary to deter- letter of credit. mine that the importation will not be (iv) Any reservation fee shall be for- likely to transmit any communicable feited if the importer or the importer’s disease to livestock or poultry of the agent fails to present for entry, within United States; or any other cir- 24 hours following the designated time cumstances which the Administrator of arrival the lot of swine for which the believes require such denial to prevent reservation was made: Except that a the dissemination of any commu- reservation fee shall not be forfeited if: nicable disease of livestock or poultry (A) Written notice of cancellation into the United States. from the importer or the importer’s (4)(i) The importer or importer’s agent is received by the office of the agent shall pay or ensure payment of a veterinarian in charge of the quar- reservation fee for each lot of swine to antine facility 6 during regular business be quarantined in a facility maintained hours (8:00 a.m. to 4:30 p.m. Monday by USDA. For swine the reservation fee through Friday, excluding holidays) no shall be 100 percent of the cost of pro- later than 15 days prior to the begin- viding care, feed, and handling during ning of the time of importation as quarantine, as estimated by the quar- specified in the import permit or as ar- antine facility’s veterinarian in charge. ranged with the veterinarian in charge (ii) At the time the importer or the of the quarantine facility if no import importer’s agent requests a reservation permit is required (the 15 day period of quarantine space, the importer or shall not include Saturdays, Sundays, importer’s agent shall pay the reserva- or holidays), or tion fee by check or U.S. money order (B) The Administrator determines or ensure payment of the reservation that services, other than provided by fee by an irrevocable letter of credit carriers, necessary for the importation from a commercial bank (the effective of the swine within the requested pe- date on such letter of credit shall run riod are unavailable because of unfore- to 30 days after the date the swine are seen circumstances as determined by scheduled to be released from quar- the Administrator, (such as the closing antine); except that anyone who issues of an airport due to inclement weather or the unavailability of the reserved a check to the Department for a res- space due to the extension of another ervation fee which is returned because quarantined.) of insufficient funds shall be denied (v) If the reservation fee was ensured any further request for reservation of a by a letter of credit and the fee is to be quarantine space until the outstanding forfeited under paragraph (a)(4)(iv) of amount is paid. this section, the Department will draw (iii) Any reservation fee paid by against the letter of credit unless the check or U.S. money order shall be ap- reservation fee is otherwise paid at plied against the expenses incurred for least 3 days prior to the expiration services received by the importer or date of the letter of credit. importer’s agent in connection with (vi) When a reservation is cancelled the quarantine for which the reserva- in accordance with paragraph tion was made. Any part of the reserva- (a)(4)(iv)(A) of this section and the pro- tion fee which remains unused after visions of paragraph (a)(4)(iv)(B) of this being applied against the expenses incurred for services received by the importer or the importer’s agent in con- 6 The addresses of USDA quarantine facili- nection with the quarantine for which ties may be found in telephone directories listing the facilities or by contacting the the reservation was made, shall be re- Animal and Plant Health Inspection Service, turned to the individual who paid the Veterinary Services, National Center for Im- reservation fee. If the reservation fee is port-Export, 4700 River Road Unit 38, River- ensured by a letter of credit, the De- dale, Maryland 20737–1231.

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section do not apply, a $40.00 cancella- as regions in which foot-and-mouth dis- tion fee shall be charged. If a reserva- ease or rinderpest exist. tion fee was paid, the cancellation fee (1) Permits for the importation of shall be deducted from any reservation wild swine will be issued only for im- fee returned to the importer or the importations through the Port of New porter’s agent. If the reservation fee York, and only if the animals are im- was ensured by a letter of credit, the ported for exhibition in a PEQ Zoo. A Department will draw the amount of PEQ Zoo is a zoological park or other the cancellation fee against the letter place maintained for the exhibition of of credit unless the cancellation fee is live animals for recreational or edu- otherwise paid at least 3 days prior to cational purposes that: the expiration date of the letter of (i) Has been approved by the Admin- credit. istrator in accordance with paragraph (b) Permit. When a permit is issued, (c)(2) of this section to receive and the original and two copies will be sent maintain imported wild swine; and to the importer. It shall be the respon- (ii) Has entered into the agreement sibility of the importer to forward the with APHIS set forth in paragraph original permit and one copy to the (c)(4) of this section for the mainte- shipper in the region of origin, and it nance and handling of imported wild shall also be the responsibility of the swine. importer to insure that the shipper (2) Approval of a PEQ Zoo shall be on presents the copy of the permit to the the basis of an inspection, by an au- carrier and makes proper arrangements thorized representative of the Depart- for the original permit to accompany ment, of the physical facilities of the the shipment to the specified U.S. port establishment and its methods of oper- of entry for presentation to the col- ation. Standards for acceptable phys- lector of customs. Swine and swine test ical facilities shall include satisfactory specimens for diagnostic screening pur- pens, cages, or enclosures in which the poses for swine intended for importa- imported swine can be maintained so tion into the United States for which a as not to be in contact with the general permit has been issued, will be received public and free from contact with do- at the specified port of entry within mestic livestock; natural or estab- the time prescribed in the permit lished drainage from the PEQ Zoo which shall not exceed 14 days from the which will avoid contamination of land first day that the permit is effective areas where domestic livestock are for all permits. Swine and swine test kept or with which domestic livestock specimens for which a permit is re- may otherwise come in contact; provi- quired by these regulations will not be sion for the disposition of manure, eligible for entry if a permit has not other wastes, and dead swine within been issued; if unaccompanied by such the PEQ Zoo; and other reasonable fa- a permit; if shipment is from any port cilities considered necessary to prevent other than the one designated in the the dissemination of diseases from the permit; if arrival in the United States PEQ Zoo. The operator of the PEQ Zoo is at any port other than the one des- shall have available the services of a ignated in the permit; if the swine or full-time or part-time veterinarian, or swine test specimens offered for entry a veterinarian on a retainer basis, who differ from those described in the per- shall make periodic examinations of all mit; if the swine or swine test speci- animals maintained at the PEQ Zoo for mens are not handled as outlined in the evidence of disease; who shall make a application for the permit and as speci- post-mortem examination of each ani- fied in the permit issued; or if mal that dies; and who shall make a ruminants or swine other than those prompt report of suspected cases of covered by import permits are aboard contagious or communicable diseases the transporting carrier. to appropriate state or federal live- (c) Wild swine from regions where foot- stock sanitary officials. and-mouth disease or rinderpest exists. (3) Manure and other animal wastes This paragraph (c) applies to the im- must be disposed of within the PEQ portation of wild swine from countries Zoo park for a minimum of one year designated in part 94 of this subchapter following the date an imported wild

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swine enters the zoo. If an APHIS vet- cation or control program in 9 CFR chapter erinarian determines that an imported I, and to assure that the animals will not swine shows no signs of any commu- have been exposed to such a disease within the 60 days next before their exportation nicable disease during this 1-year pe- from that region. riod, its manure and other wastes need 2. Shipment will be made direct from such not be disposed of within the zoo after port of embarkation to the port of New York the 1-year period. If, however, an as the sole port of entry in this region. If APHIS veterinarian determines that shipment is made by ocean vessel, the ani- the swine does show signs of any com- mals will not be unloaded in any foreign port municable disease during this 1-year en route. If shipment is made by air, the ani- period, an APHIS veterinarian will in- mals will not be unloaded at any port or other place of landing, except at a port ap- vestigate the disease and determine proved by the Administrator as a port not lo- whether the swine’s manure and other cated in a region where rinderpest or foot- wastes may safely be disposed of out- and-mouth disease exists or as a port in such side the zoo after the 1-year period has a region having facilities and inspection ade- ended. quate for maintaining wild animals in isola- (4) Prior to the issuance of an import tion from all other animals. permit under this section, the operator 3. No ruminants or swine will be aboard the transporting vehicle, vessel or aircraft, ex- of the approved PEQ Zoo to which the cept those for which an import permit has imported swine are to be consigned, been issued. and the importer of the swine, if such 4. The animals will be quarantined for not operator and importer are different less than 30 days in the Department’s Ani- parties, shall execute an agreement mal Import Center in Newburgh, New York. covering each swine or group of swine 5. Upon release from quarantine the ani- for which the import permit is re- mals will be delivered to the zoological park named in this agreement to become the prop- quested. The agreement shall be in the erty of the park and they will not be sold, following form: exchanged or removed from the premises without the prior consent of APHIS. If AGREEMENT FOR THE IMPORTATION, moved to another zoological park in the QUARANTINE AND EXHIBITION OF CER- United States, the receiving zoological park TAIN WILD RUMINANTS AND WILD must be approved by the Administrator in SWINE accordance with paragraph 6 of this agreement. llll, operator(s) of the zoological park 6. The Administrator will approve the known as llllll (Name) located at movement of an imported animal subject to lllllll (City and state), and this agreement if the Administrator deter- llllll (Importer) hereby request a per- mines that the animal has spent at least one mit for the importation of llll (Number year in quarantine in a PEQ Zoo following and kinds of animals) for exhibition purposes importation without showing clinical evi- at the said zoological park, said animals dence of foot-and-mouth disease, rinderpest, originating in a region where foot-and- or other communicable disease that is exotic mouth disease or rinderpest exists and being to the United States or for which APHIS has subject to restrictions under regulations an eradication or control program in 9 CFR contained in part 93, title 9, Code of Federal chapter I, and determines that the receiving Regulations. zoological park is accredited by the Amer- In making this request, it is understood ican Zoo and Aquarium Association (AZA), and agreed that: or the receiving zoological park has facilities 1. The animals for which an import permit and procedures in place related to preventing is requested will be held in isolation at a the spread of communicable animal diseases port of embarkation in the region of origin, (including but not limited to procedures for approved by the Administrator as a port hav- animal identification, record keeping, and ing facilities which are adequate for main- veterinary care) that are equivalent to those taining wild animals in isolation from all required for AZA accreditation. The Admin- other animals and having veterinary super- istrator will approve the movement of a car- vision by officials of the region of origin of cass, body part, or biological specimen de- the animals. Such animals will be held in rived from an imported animal subject to such isolation for not less than 60 days under this agreement if the Administrator deter- the supervision of the veterinary service of mines that the animal has spent at least one that region to determine whether the ani- year in quarantine in a PEQ Zoo following mals show any clinical evidence of foot-and- importation without showing clinical evi- mouth disease, rinderpest, or other commu- dence of foot-and-foot mouth disease, rinder- nicable disease that is exotic to the United pest, or other communicable disease that is States or for which APHIS has an eradi- exotic to the United States or for which

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APHIS has an eradication or control pro- contagious pleuropneumonia, may gram in 9 CFR chapter I, and determines specify freedom from such disease of that the carcass, body part, or biological the district of origin only. For domes- specimen will be moved only for scientific research or museum display purposes. tic swine, the certificate shall also show that the entire region of origin is llllllllllllllllllllllll free of African swine fever and swine (Signature of importer) Subscribed and sworn to before me this vesicular disease and that, for 60 days ll day of ll, ll immediately preceding the time of llllllllllllllllllllllll movement from the premises of origin, (Title or designation) no swine erysipelas or swine plague has llllllllllllllllllllllll existed on such premises or on adjoin- (Name of zoological park) ing premises. Additionally, except for By lllllllllllllllllllll the APHIS-defined European CSF re- (Signature of officer of zoological park) gion, as defined in § 94.0 of this sub- llllllllllllllllllllllll chapter, for which additional certifi- (Title of officer) cation is required under § 94.24(b)(6), for Subscribed and sworn to before me this domestic swine the certificate shall day of , ll ll ll show that the entire region of origin is llllllllllllllllllllllll free of classical swine fever. (Title or designation) (b) Swine from any region where (Approved by the Office of Management and screwworm is considered to exist may Budget under control number 0579–0040) only be imported into the United [55 FR 31495, Aug. 2, 1990 as amended at 59 FR States if they meet the requirements of 28216, June 1, 1994; 59 FR 31924, June 21, 1994; paragraphs (b)(1) through (b)(4) of this 59 FR 67615, Dec. 30, 1994; 62 FR 23638, May 1, section and all other applicable re- 1997. Redesignated and amended at 62 FR 56012, 56020, Oct. 28, 1997; 68 FR 6344, Feb. 7, quirements of this part. APHIS will 2003] maintain a list of regions where screwworm is considered to exist on § 93.505 Certificate for swine. the APHIS Web site at http:// (a) All swine offered for importation www.aphis.usda.gov/importlexport/ani- from any part of the world except as mals/animalldiseaselstatus.shtml. Cop- provided in § 93.517 shall be accom- ies of the list will also be available via panied by a certificate of a salaried postal mail, fax, or email upon request veterinary officer of the national gov- to the Sanitary Trade Issues Team, Na- ernment of the region of origin, or if tional Center for Import and Export, exported from Mexico, shall be accom- Veterinary Services, Animal and Plant panied either by such a certificate or Health Inspection Service, 4700 River by a certificate issued by a veteri- Road Unit 38, Riverdale, Maryland narian accredited by the National Gov- 20737. APHIS will add a region to the ernment of Mexico and endorsed by a list upon determining that screwworm full-time salaried veterinary officer of exists in the region based on reports the National Government of Mexico, APHIS receives of detections of the thereby representing that the veteri- pest from veterinary officials of the ex- narian issuing the certificate was au- porting country, from the World Orga- thorized to do so, stating that such nization for Animal Health (OIE), or swine have been kept in said region at from other sources the Administrator least 60 days immediately preceding determines to be reliable. APHIS will the date of movement therefrom and remove a region from the list after con- that said region during such period has ducting an evaluation of the region in been entirely free from foot-and-mouth accordance with § 92.2 of this sub- disease, rinderpest, contagious chapter and finding that screwworm is pleuropneumonia, and surra: Provided, not present in the region. In the case of however, That certificates for wild a region formerly not on this list that swine for exhibition purposes need is added due to a detection, the region specify freedom from the said diseases may be removed from the list in ac- of the district of origin only: And pro- cordance with the procedures for rees- vided further, That in the case of swine tablishment of a region’s disease-free the certificate, as far as it relates to status in § 92.4 of this subchapter.

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(1) A veterinarian must treat the the use of the veterinary inspector at swine with ivermectin 3 to 5 days prior the port of entry. to the date of export to the United (b) For all swine offered for importa- States according to the recommended tion, the importer or his or her agent dose prescribed on the product’s label. shall first present two copies of a dec- (2) The swine must be fully examined laration which shall list the port of for screwworm by a full-time salaried entry, the name and address of the im- veterinary official of the exporting porter, the name and address of the country within 24 hours prior to ship- broker, the origin of the swine, the ment to the United States. If swine are number, breed, species, and purpose of found to be infested with screwworm, the importation, the name of the per- they must be treated until free from son to whom the swine will be deliv- infestation. ered, and the location of the place to (3) At the time swine are loaded onto which such delivery will be made. a means of conveyance for export, a veterinarian must treat any visible § 93.507 Inspection at the port of wounds on the animals with a solution entry. of coumaphos dust at a concentration Inspection shall be made at the port of 5 percent active ingredient. of entry of all swine imported from any (4) The swine must be accompanied to the United States by a certificate part of the world except as provided in signed by a full-time salaried veteri- § 93.519. All swine found to be free from nary official of the exporting country. communicable disease and not to have The certificate must state that the been exposed thereto within 60 days swine have been thoroughly examined prior to their exportation to the United and found free of screwworm and that States shall be admitted subject to the the swine have been treated in accord- other provisions in this part; all other ance with paragraphs (b)(1) and (b)(3) of swine shall be refused entry. Swine re- this section. fused entry, unless exported within a (c) If swine are unaccompanied by the time fixed in each case by the Adminis- certificate as required by paragraph (a) trator, and in accordance with other of this section, or if such swine are provisions he or she may require in found upon inspection at the port of each case for their handling shall be entry to be affected with a commu- disposed of as the Administrator may nicable disease or to have been exposed direct. Such portions of the trans- thereto, they shall be refused entry and porting vessel, and of its cargo, which shall be handled or quarantined, or have been exposed to any such swine or otherwise disposed of as the Adminis- their emanations shall be disinfected trator may direct. in such manner as may be considered necessary by the inspector in charge at (Approved by the Office of Management and Budget under control number 0579–0165) the port of entry, to prevent the introduction or spread of livestock or poul- [55 FR 31495, Aug. 2, 1990, as amended at 57 try disease, before the cargo is allowed FR 28081, June 24, 1992. Redesignated and to land. amended at 62 FR 56012, 56020, Oct. 28, 1997; 65 FR 67623, Nov. 13, 2000; 67 FR 11565, Mar. 15, [55 FR 31495, Aug. 2, 1990. Redesignated and 2002; 68 FR 6344, Feb. 7, 2003; 68 FR 16938, Apr. amended at 62 FR 56012, 56020, Oct. 28, 1997; 68 7, 2003; 71 FR 29070, May 19, 2006; 71 FR 31069, FR 6344, Feb. 7, 2003] June 1, 2006; 72 FR 67232, Nov. 28, 2007; 73 FR 50878, Aug. 29, 2008; 76 FR 70039, Nov. 10, 2011; § 93.508 Articles accompanying swine. 77 FR 1391, Jan. 10, 2012] No litter or manure, fodder or other § 93.506 Declaration and other docu- aliment, nor any equipment such as ments for swine. boxes, buckets, ropes, chains, blankets, (a) The certificates, declarations, and or other things used for or about swine affidavits required by the regulations governed by the regulations in this in this part shall be presented by the part, shall be landed from any convey- importer or his or her agent to the col- ance except under such restrictions as lector of customs at the port of entry, the inspector in charge at the port of upon arrival of swine at such port, for entry shall direct.

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§ 93.509 Movement from conveyances the quarantine of such swine and must to quarantine station. be approved by the Administrator prior Platforms and chutes used for han- to the issuance of any import permit. dling imported swine shall be cleaned The facilities occupied by swine should and disinfected under APHIS super- be kept clean and sanitary to the satis- vision after being so used. The said faction of the inspector assigned to su- swine shall not be unnecessarily moved pervise the quarantine. If for any cause over any highways nor allowed to come the care, feed, or handling of swine, or in contact with other swine, but shall the sanitation of the facilities, is ne- be transferred from the conveyance to glected, in the opinion of the inspector the quarantine grounds in boats, cars, assigned to supervise the quarantine, or vehicles approved by the inspector such services may be furnished by in charge at the port of entry. Such APHIS in the same manner as though cars, boats, or vehicles shall be cleaned arrangements had been made for such and disinfected under APHIS super- services as provided by paragraph (b) of vision immediately after such use, by this section, and/or the swine may be the carrier moving the same. The rail- disposed of as the Administrator, may way cars so used shall be either cars re- direct, including sale in accordance served for this exclusive use or box cars with the procedure described in para- not otherwise employed in the trans- graph (b) of this section. The importer, portation of swine or their fresh prod- or his or her agent, shall request in ucts. When movement of the aforesaid writing such inspection and other serv- swine upon or across a public highway ices as may be required, and shall is unavoidable, it shall be under such waive all claim against the United careful supervision and restrictions as States and APHIS or any employee of the inspector in charge at the port of APHIS for damages which may arise entry and the local authorities may di- from such services. The Administrator, rect. may prescribe reasonable rates for the services provided under this paragraph. § 93.510 Quarantine requirements. When it is found necessary to extend Swine shall be quarantined for not the usual minimum quarantine period, less than 15 days, counting from the the importer, or his or her agent, shall date of arrival at the port of entry. be so advised in writing and shall pay During their quarantine, wild swine for such additional quarantine and shall be subject to such inspections, other services required. Payment for disinfection, blood tests, or other tests all services received by the importer, as may be required by the Adminis- or his or her agent, in connection with trator, to determine their freedom each separate lot of swine shall be from disease and the infection of dis- made by certified check or U.S. money ease. order prior to release of the swine. If such payment is not made, the swine § 93.511 Swine quarantine facilities. may be sold in accordance with the (a) Privately operated quarantine facili- procedure described in paragraph (b) of ties. The importer, or his or her agent, this section, or otherwise disposed of as of swine subject to quarantine under directed by the Administrator. the regulations in this part shall ar- (b) Quarantine facilities maintained by range for acceptable transportation to APHIS. The importer, or his or her the privately operated quarantine fa- agent, of swine subject to quarantine cility and for the care, feed, and han- under the regulations in this part shall dling of the swine from the time of un- arrange for acceptable transportation loading at the quarantine port to the to the quarantine facility, and for the time of release from quarantine. Such care, feed, and handling of the swine arrangements shall be agreed to in ad- from the time they arrive at the quar- vance by the Administrator. All ex- antine facility, and for the care, feed, penses resulting therefrom or incident and handling of the swine from the thereto shall be the responsibility of time they arrive at the quarantine port the importer; APHIS assumes no re- to the time of release from quarantine. sponsibility with respect thereto. The Such arrangements shall be agreed to quarantine facility must be suitable for in advance by the Administrator. The

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importer or his or her agent shall re- available for defraying the expenses in- quest in writing such inspection and volved in this service. other services as may be required, and shall waive all claim against the § 93.512 Quarantine stations, visiting United States and APHIS or any em- restricted; sales prohibited. ployee of APHIS, for damages which Visitors shall not be admitted to the may arise from such services. All ex- quarantine enclosure during any time penses resulting therefrom or incident that swine are in quarantine except thereto shall be the responsibility of that an importer (or his or her accred- the importer; APHIS assumes no re- ited agent or veterinarian) may be ad- sponsibility with respect thereto. The mitted to the yards and buildings con- Administrator may prescribe reason- taining his or her quarantined swine at able rates for the services provided such intervals as may be deemed nec- under this paragraph. When it is found essary, and under such conditions and necessary to extend the usual min- restrictions as may be imposed, by the imum quarantine period, the importer, inspector in charge of the quarantine or his or her agent, shall be so advised station. On the last day of the quar- in writing and shall pay for such addi- antine period, owners, officers or reg- tional quarantine and other services istry societies, and others having offi- required. Payment for services received cial business or whose services may be by the importer, or his or her agent, in necessary in the removal of the swine connection with each separate lot of may be admitted upon written permis- swine shall be made by certified check sion from the said inspector. No exhi- or U.S. money order prior to release of bition or sale shall be allowed within the swine. If such payment is not the quarantine grounds. made, the swine may be sold in accordance with the procedure described in § 93.513 Milk from quarantined swine. this paragraph or otherwise disposed of Milk or cream from swine quar- as directed by the Administrator. When antined under the provisions of this payment is not made and the swine are part shall not be used by any person to be sold to recover payment for serv- other than those in charge of such ices received, the importer, or his or swine, nor be fed to any animals other her agent, will be notified by the in- than those within the same enclosure, spector that if said charges are not im- without permission of the inspector in mediately paid or satisfactory arrange- charge of the quarantine station and ments made for payment, the swine subject to such restrictions as he or will be sold at public sale to pay the she may consider necessary to each in- expense of care, feed, and handling dur- stance. No milk or cream shall be re- ing that period. The sale will be held moved from the quarantine premises after the expiration of the quarantine except in compliance with all State period, at such time and place as may and local regulations. be designated by the General Services Administration or other designated § 93.514 Manure from quarantined selling agent. The proceeds of the sale, swine. after deducting the charges for care, No manure shall be removed from the feed, and handling of the swine and quarantine premises until the release other expenses, including the expense of the swine producing same. of the sale, shall be held in a Special Deposit Account in the United States § 93.515 Appearance of disease among Treasury for 6 months from the date of swine in quarantine. sale. If not claimed by the importer, or If any contagious disease appears his or her agent, within 6 months from among swine during the quarantine pe- the date of sale, the amount so held riod special precautions shall be taken shall be transferred from the Special to prevent spread of the infection to Deposit Account to the General Fund other animals in the quarantine sta- Account in the United States Treasury. tion or to those outside the grounds. (c) Amounts collected from the im- The affected swine shall be disposed of porter, or his or her agent, for service as the Administrator may direct, de- rendered shall be deposited so as to be pending upon the nature of the disease.

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CANADA 7 tion but shall be subject to the provisions of §§ 93.507, 93.516, and 93.518. § 93.516 Import permit and declaration for swine. [55 FR 34195, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56020, Oct. 28, 1997; 68 (a) For swine intended for importa- FR 16938, Apr. 7, 2003] tion from Canada, the importer shall first apply for and obtain from APHIS § 93.518 Swine from Canada for imme- an import permit as provided in § 93.504: diate slaughter. Provided, That an import permit is not Swine imported from Canada for im- required for swine offered for entry at mediate slaughter shall be consigned a land border port designated in from the port of entry directly to a rec- § 93.503(b) if such swine: ognized slaughtering establishment (1) Was born in Canada or the United and there be slaughtered within two States, and has been in no region other weeks from the date of entry. As used than Canada or the United States, or in this section, ‘‘directly’’ means with- (2) Has been legally imported into out unloading en route if moved in a Canada from some other region and un- means of conveyance, or without stop- conditionally released in Canada so as ping if moved in any other manner. to be eligible to move freely within [55 FR 31495, Aug. 2, 1990, as amended at 59 that region without restriction of any FR 28216, June 1, 1994. Redesignated at 62 FR kind and has been in Canada after such 56012, Oct. 28, 1997] release for 60 days or longer. (b) For all swine offered for importa- § 93.519 Special provisions. tion from Canada, the importer or his (a) In-bond shipments from Canada. (1) or her agent shall present two copies of Swine from Canada transported in- a declaration as provided in § 93.506. bond through the United States for immediate export shall be inspected at [55 FR 31495, Aug. 2, 1990. Redesignated and the border port of entry and, when ac- amended at 62 FR 56012, 56020, Oct. 28, 1997] companied by an import permit ob- § 93.517 Swine from Canada. tained under § 93.504 of this part and all conditions therein are observed, shall (a) For purposes other than immediate be allowed entry into the United States slaughter. Swine offered for importa- and shall be otherwise handled as pro- tion from Canada for purposes other vided in paragraph (b) of § 93.501. Swine than immediate slaughter shall be ac- not accompanied by a permit shall companied by a certificate issued or meet the requirements of this part in endorsed by a salaried veterinarian of the same manner as swine destined for the Canadian Government showing importation into the United States, ex- that said swine have been inspected on cept that the Administrator may per- the premises of origin immediately be- mit their inspection at some other fore the date of movement therefrom point when he or she finds that such and found to be free of evidence of com- action will not increase the risk that municable disease and that, as far as it communicable diseases of livestock has been possible to determine, they and poultry will be disseminated to the were not exposed to any such disease livestock or poultry of the United during the preceding 60 days; in addi- States. tion, the certificate shall show that no (2) In-transit shipments through Can- classical swine fever or swine plague ada. Swine originating in the United has existed on the premises of origin or States and transported directly on adjoining premises for such 60 days. through Canada may re-enter the (b) For immediate slaughter. Swine for United States without Canadian health immediate slaughter may be imported or test certificates when accompanied from Canada without certification as by copies of the United States export prescribed in paragraph (a) of this sec- health certificates properly issued and endorsed in accordance with regula- 7 Importations from Canada shall be sub- tions in part 91 of this chapter: Pro- ject to §§ 93.516 to 93.519, inclusive, in addi- vided, That, to qualify for entry, the tion to other sections in this part which are date, time, port of entry, and signature in terms applicable to such importations. of the Canadian Port Veterinarian that

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inspected the swine for entry into Can- MEXICO 9 ada shall be recorded on the United States health certificate, or a paper § 93.521 Declaration for swine. containing the information shall be at- For all swine offered for importation tached to the certificate that accom- from Mexico, the importer or his or her panies the swine. In all cases it shall be agent shall present two copies of a dec- determined by the veterinary inspector laration as provided in § 93.506. at the United States port of entry that the swine are the identical swine cov- [55 FR 34195, Aug. 2, 1990. Redesignated and ered by said certificate. amended at 62 FR 56012, 56020, Oct. 28, 1997] (b) Exhibition swine. Swine from the United States which have been exhib- Subpart F—Dogs ited at the Royal Agricultural Winter Fair at Toronto or other publicly rec- § 93.600 Importation of dogs. ognized expositions in Canada, includ- (a) All dogs. Dogs from any region of ing racing, rodeo, circus, or stage exhibitions in Canada, and have not been in the world where screwworm is consid- that region for more than 90 days are ered to exist may only be imported eligible for return to the United States into the United States if they meet the without Canadian health or test cer- requirements of paragraphs (a)(1) and tificates, if they are accompanied by (2) of this section and all other applica- copies of the United States health cer- ble requirements of this part. APHIS tificate, issued and endorsed in accord- will maintain a list of regions where ance with the export regulations con- screwworm is considered to exist on tained in Part 91 of this chapter for the APHIS Web site at http:// entry into Canada: Provided, That all www.aphis.usda.gov/importlexport/ani- swine offered for re-entry upon exam- mals/animalldiseaselstatus.shtml. Cop- ination by the veterinary inspector at ies of the list will also be available via the U.S. port of entry, are found by the postal mail, fax, or email upon request inspector to be free of communicable to the Sanitary Trade Issues Team, Na- diseases and exposure thereto and are tional Center for Import and Export, determined to be the identical swine Veterinary Services, Animal and Plant covered by said certificates or are the Health Inspection Service, 4700 River natural increase of such swine born Road Unit 38, Riverdale, Maryland after official test dates certified on the 20737. APHIS will add a region to the dam’s health certificate. list upon determining that screwworm exists in the region based on reports (Approved by the Office of Management and Budget under control number 0579–0020) APHIS receives of detections of the pest from veterinary officials of the ex- [55 FR 31495, Aug. 2, 1990, as amended at 59 porting country, from the World Orga- FR 67133, Dec. 29, 1994. Redesignated and amended at 62 FR 56012, 56020, Oct. 28, 1997] nization for Animal Health (OIE), or from other sources the Administrator CENTRAL AMERICA AND WEST INDIES 8 determines to be reliable. APHIS will remove a region from the list after con- § 93.520 Import permit and declaration ducting an evaluation of the region in for swine. accordance with § 92.2 of this sub- For all swine offered for importation chapter and finding that screwworm is from countries of Central America or not present in the region. In the case of of the West Indies, the importer or his a region formerly not on this list that or her agent shall present two copies of is added due to a detection, the region a declaration as provided in § 93.506. may be removed from the list in accordance with the procedures for rees- [55 FR 34195, Aug. 2, 1990. Redesignated and amended at 62 FR 56012, 56020, Oct. 28, 1997] tablishment of a region’s disease-free status in § 92.4 of this subchapter. 8 Importations from regions of Central America and the West Indies shall be subject 9 Importations from Mexico shall be sub- to § 93.520, in addition to other sections in ject to § 93.521, in addition to other sections this part, which are in terms applicable to in this subpart, which are in terms applica- such importations. ble to such importations.

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(1) Dogs must be accompanied by a Brushtail possum. Vulpine phalangers certificate signed by a full-time sala- (Trichosurus vulpecula) of the family ried veterinary official of the region of Phalangeridae. origin stating that the dog has been in- Delivery. The transfer of goods or inspected for screwworm within 5 days terest in goods from one person to an- preceding its shipment to the United other. States. Enter (entry). To introduce into the (2) The certificate must state that commerce of the United States after the dog is either free from screwworm release from government detention. or was found to be infested with Hedgehog. All members of the family screwworm and was held in quarantine Erinaceidae. and treated until free from screwworm Import (imported, importation). To prior to leaving the region of origin. bring into the territorial limits of the (b) Dogs for handling livestock. Collie, United States. Shepherd, and other dogs that are im- Inspector. An employee of the Animal ported from any part of the world ex- and Plant Health Inspection Service cept Canada, Mexico, and regions of authorized to perform duties required Central America and the West Indies under this subpart. and that are to be used in the handling Person. Any individual, corporation, of sheep or other livestock must be in- company, association, firm, partner- spected and quarantined at the port of ship, society, or joint stock company. entry for a sufficient time to determine Region. Any defined geographic land their freedom from tapeworm (Taenia area identifiable by geological, polit- spp.). If found to be infested with tape- ical, or surveyed boundaries. A region worm, dogs must be treated under the may consist of any of the following: supervision of an inspector at the port (1) A national entity (country); of entry until they are free from infes- (2) Part of a national entity (zone, tation. county, department, municipality, par- (Approved by the Office of Management and ish, Province, State, etc.) Budget under control number 0579–0165) (3) Parts of several national entities [65 FR 67623, Nov. 13, 2000, as amended at 67 combined into an area; or FR 11565, Mar. 15, 2002; 73 FR 50878, Aug. 29, (4) A group of national entities (coun- 2008; 77 FR 1391, Jan. 10, 2012] tries) combined into a single area. Tenrec. All members of the family Subpart G—Miscellaneous Tenrecidae. Animals United States. All of the States of the United States, the District of Colum- bia, Guam, the Northern Mariana Is- SOURCE: 60 FR 55181, unless otherwise lands, Puerto Rico, the Virgin Islands noted. Redesignated at 62 FR 56012, Oct. 28, 1997. of the United States, and all other territories and possessions of the United § 93.700 Definitions. States. Wherever in this subpart the fol- [55 FR 34195, Aug. 2, 1990. Redesignated and lowing terms are used, unless the con- amended at 62 FR 56012, 56020, Oct. 28, 1997] text otherwise requires, they shall be construed, respectively, to mean: § 93.701 Prohibitions. Administrator. The Administrator of (a) No person may import a hedgehog the Animal and Plant Health Inspec- or tenrec into the United States from tion Service or any other employee of any region designated in § 94.1 of this the Animal and Plant Health Inspec- chapter as a region where foot-and- tion Service, United States Depart- mouth disease exists. ment of Agriculture, delegated to act (b) No person may import a brushtail in the Administrator’s stead. possum or hedgehog into the United Animal and Plant Health Inspection States from New Zealand. Service. The Animal and Plant Health (c) No person may import leopard Inspection Service of the United States tortoise (Geochelone pardalis), African Department of Agriculture (APHIS). spurred tortoise (Geochelone sulcata), or

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Bell’s hingeback tortoise (Kinixys with the concurrence of the Secretary belliana) into the United States. of the Treasury. [55 FR 31495, Aug. 2, 1990. Redesignated and [60 FR 55181, Oct. 30, 1995. Redesignated at 62 amended at 56012, 56021, Oct. 28, 1997; 65 FR FR 56012, Oct. 28, 1997, as amended at 65 38178, 15218, Mar. 22, 2000] June 20, 2000; 67 FR 68022, Nov. 8, 2002]

§ 93.702 Restrictions. § 93.704 Import permit. (a) General requirements. No person Hedgehogs and tenrecs not specifi- may import a hedgehog or tenrec into cally prohibited from being imported the United States unless it is accom- under § 93.701 may be imported into the panied by an import permit issued by United States only in accordance with APHIS and is imported into the United the regulations in this subpart. States within 30 days after the pro- [55 FR 31495, Aug. 2, 1990. Redesignated and posed date of arrival stated in the im- amended at 62 FR 56012, 56021, Oct. 28, 1997] port permit. The importer or his or her agent must notify the inspector at the § 93.703 Ports designated for importa- port of first arrival of the date of ar- tion. rival at least 72 hours before the hedge- (a) Any person importing a hedgehog hog or tenrec arrives in the United or tenrec into the United States may States. import it, except as provided in para- (b) Import permit required. Any person graph (b) of this section, only through who desires to import a hedgehog or the following ports: tenrec must complete and submit one copy of an application (VS Form 17–129) (1) Air and ocean ports. Anchorage and for an import permit to the Import-Ex- Fairbanks, AK; San Diego and Los An- port Animals Staff, National Center for geles, CA; Denver, CO; Jacksonville, Import-Export, Veterinary Services, Miami, St. Petersburg-Clearwater, and Animal and Plant Health Inspection Tampa, FL; Atlanta, GA; Chicago, IL; Service, United States Department of New Orleans, LA; Portland, ME; Balti- Agriculture, 4700 River Road Unit 39, more, MD; Boston, MA; Minneapolis, Riverdale, Maryland 20737–1231. This MN; Great Falls, MT; Newburgh, NY; staff will supply application forms for Portland, OR; San Juan, PR; Galveston import permits upon request. A sepa- and Houston, TX; and Seattle, Spo- rate application must be prepared for kane, and Tacoma, WA. each shipment. (2) Canadian border ports. Eastport, (c) Application for an import permit. ID; Houlton and Jackman, ME; De- The importer must complete, sign, and troit, Port Huron, and Sault Ste. date the application for an import per- Marie, MI; Opheim, Raymond, and mit, which must include the following Sweetgrass, MT; Alexandria Bay, Buf- information: falo, and Champlain, NY; Dunseith, (1) The name and address of the ship- Pembina, and Portal, ND; Derby Line per in the region of origin of the hedge- and Highgate Springs, VT; Oroville and hog or tenrec intended for importation Sumas, WA. into the United States. (3) Mexican border ports. Douglas, (2) The name, address, and telephone Naco, Nogales, Sasabe, and San Luis, number of the importer. (3) The port of embarkation. AZ; Calexico and San Ysidro, CA; Ante- (4) The region from which the hedge- lope Wells, and Columbus, NM; and hog or tenrec will be shipped to the Brownsville, Hidalgo, Laredo, Eagle United States. Pass, Del Rio, Presidio, and El Paso, (5) The mode of transportation. TX. (6) The number, breed, species, and (b) The Secretary of the Treasury has descriptions of the hedgehogs or approved the designation, as inspection tenrecs to be imported. stations, of the ports specified in para- (7) The purpose of the importation. graph (a) of this section. In special (8) The route of travel, including all cases, the Administrator may des- carrier stops en route. ignate other ports as inspection sta- (9) The proposed shipping and arrival tions in accordance with this section, dates.

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(10) The port of first arrival in the (4) That the hedgehog or tenrec was United States. inspected by the individual issuing the (11) The name, mailing address, and health certificate and was found free of telephone number of the person to any ectoparasites not more than 72 whom the hedgehog or tenrec will be hours before being loaded on the means delivered in the United States. of conveyance which transported the (12) The location of the place where animal to the United States; delivery will be made in the United (5) That all body surfaces of the States. hedgehog or tenrec were treated for (13) Any remarks regarding the ship- ectoparasites under the supervision of ment. the veterinarian issuing the health cer- (d) Issuance of an import permit. Upon tificate at least 3 days but not more receipt of the application, APHIS will than 14 days before being loaded on the review the application. If the hedgehog means of conveyance that transported or tenrec appears to be eligible to be the animal to the United States; imported into the United States, (6) That the pesticide and the con- APHIS will issue an import permit in- centration used would kill the types of dicating the applicable requirements ectoparasites that may infest the ani- under this subpart for the importation mal to be imported; of the hedgehog or tenrec. Even though (7) That the hedgehog or tenrec, after an import permit has been issued for being treated for ectoparasites in ac- the importation of a hedgehog or cordance with paragraphs (a)(5) and tenrec, the animal may enter the (a)(6) of this section, had physical con- United States only if all other applica- tact only with, or shared a pen or bed- ble requirements of this subpart have ding materials only with, treated been met. hedgehogs or tenrecs in the same ship- (Approved by the Office of Management and ment to the United States; and Budget under control number 0579–0040) (8) The name and concentration of [55 FR 31495, Aug. 2, 1990. Redesignated and the pesticide used to treat the hedge- amended at 62 FR 56012, 56021, Oct. 28, 1997] hog or tenrec. (b) [Reserved] § 93.705 Health certificate. (Approved by the Office of Management and (a) No person may import a hedgehog Budget under control number 0579–0040) or tenrec into the United States unless it is accompanied by a health certifi- [55 FR 31495, Aug. 2, 1990. Redesignated and cate either issued by a full-time sala- amended at 62 FR 56012, 56021, Oct. 28, 1997] ried veterinary officer of the national § 93.706 Notification of arrival. government of the exporting region or issued by a veterinarian authorized or Upon the arrival of a hedgehog or accredited by the national government tenrec at the port of first arrival in the of the exporting region and endorsed by United States, the importer or his or a full-time salaried veterinary officer her agent must present the import per- of the national government of that re- mits and health certificates required gion. The health certificate must con- by this subpart to the collector of cus- tain the names and street addresses of toms for the use of the inspector at the consignor and consignee and must that port. state: (1) That the hedgehog or tenrec origi- § 93.707 Inspection at the port of first nated in a region that has been recog- arrival. nized as free of foot-and-mouth disease (a) A hedgehog or tenrec from any by the USDA; part of the world must be inspected by (2) That the hedgehog or tenrec has an APHIS inspector at the port of first never been in a region where foot-and- arrival. Subject to the other provisions mouth disease exists; in this subpart, a shipment of hedge- (3) That the hedgehog or tenrec has hogs or tenrecs may enter the United not been commingled with any other States only if each hedgehog or tenrec hedgehog or tenrec that originated in in the shipment is found free of or has ever been in a region where foot- ectoparasites and any clinical signs of and-mouth disease exists; communicable diseases.

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(b) If any hedgehog or tenrec in a Incinerate (incinerated). To reduce to shipment is found to be infested with ash by burning. ectoparasites or demonstrates any clin- Inspector. An employee of APHIS who ical signs of communicable diseases, is authorized to perform the function then the entire shipment will be re- involved. fused entry. The importer will be given Person. Any individual, corporation, the following options: company, association, firm, partner- (1) Remove the shipment from the ship, society, joint stock company, or United States; or any other legal entity. (2) Release the shipment to the U.S. Region. Any defined geographic land Department of Agriculture. The Ad- area identifiable by geological, polit- ministrator will destroy or otherwise ical, or surveyed boundaries. A region dispose of the shipment as necessary to may consist of any of the following: prevent the possible introduction into the United States of communicable (1) A national entity (country); animal diseases. (2) Part of a national entity (zone, county, department, municipality, par- Subpart H—Elephants, Hippo- ish, Province, State, etc.) (3) Parts of several national entities potami, Rhinoceroses, and combined into an area; or Tapirs (4) A group of national entities (coun- § 93.800 Definitions. tries) combined into a single area. United States. All of the several The following terms, when used in States of the United States, the Dis- this part, shall be construed as defined. trict of Columbia, Guam, the Northern Those terms used in the singular form Mariana Islands, Puerto Rico, the Vir- in this part shall be construed as the gin Islands of the United States, and plural form and vice versa, as the case all other territories and possessions of may demand. the United States. Accredited veterinarian. A veterinarian approved by the Administrator United States health certificate. An of- in accordance with part 161 of this ficial document issued by an APHIS chapter to perform functions specified representative or an accredited veteri- in parts 1, 2, 3, and 11 of this chapter, narian at the point of origin of a move- and subchapters B, C, and D of this ment of animals. It must show the chapter; and to perform functions re- identification tag, tattoo, or registra- quired by cooperative State-Federal tion number of each animal to be disease control and eradication pro- moved; the age and sex of each animal grams. to be moved; the number of animals Administrator. The Administrator, covered by the document; the points of Animal and Plant Health Inspection origin and destination; the consignor; Service, or any person authorized to and the consignee. act for the Administrator. Veterinary Services. The Veterinary Animal and Plant Health Inspection Services unit of the Animal and Plant Service. The Animal and Plant Health Health Inspection Service of the United Inspection Service of the United States States Department of Agriculture. Department of Agriculture (APHIS). APHIS representative. A veterinarian [52 FR 29502, Aug. 10, 1987, as amended at 57 FR 23048, 23049, June 1, 1992. Redesignated or other person employed by APHIS in and amended at 62 FR 56012, 56021, Oct. 28, animal health activities, who is au- 1997] thorized to perform the function involved. § 93.801 Prohibitions. Enter (entered, entry) into the United Elephants, hippopotami, rhinoc- States. To introduce into the commerce eroses, or tapirs shall not be imported of the United States after release from government detention. or entered into the United States unless in accordance with this part. Import (imported, importation) into the United States. To bring into the terri- [52 FR 29502, Aug. 10, 1987. Redesignated at 62 torial limits of the United States. FR 56012, Oct. 28, 1997]

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§ 93.802 Import permit. the United States shall be issued for (a) An elephant, hippopotamus, rhi- the importation of the elephant, hippo- noceros, or tapir shall not be imported potamus, rhinoceros, or tapir described into the United States unless accom- in the application if such animal ap- panied by an import permit issued by pears to be eligible to be imported. APHIS and unless imported into the Even though an import permit has United States within 30 days after the been issued for the importation of an proposed date of arrival stated in the elephant, hippopotamus, rhinoceros, or import permit. The port veterinarian tapir, the animal may be imported only must be notified of the date of arrival if all applicable requirements of this at least 72 hours before the animal ar- part are met. rives in the United States. [52 FR 29502, Aug. 10, 1987, as amended at 57 (b) An application for an import per- FR 23049, June 1, 1992; 59 FR 67615, Dec. 30, mit must be submitted to the Animal 1994. Redesignated at 62 FR 56012, Oct. 28, and Plant Health Inspection Service, 1997] Veterinary Services, National Center § 93.803 Health certificate. for Import-Export, 4700 River Road Unit 38, Riverdale, Maryland 20737–1231. (a) An elephant, hippopotamus, rhi- pplication forms for import permits noceros, or tapir shall not be imported may be obtained from this staff. into the United States unless accom- (c) The completed application shall panied by a health certificate either include the following information: signed by a salaried veterinarian of the (1) The name and address of the per- national veterinary services of the re- son intending to export an elephant, gion where the inspection and treat- hippopotamus, rhinoceros, or tapir to ment required by this section occurred the United States; or signed by a veterinarian authorized (2) The name and address of the per- by the national veterinary services of son intending to import an elephant, such region and endorsed by a salaried hippopotamus, rhinoceros, or tapir into veterinarian of the national veterinary the United States; services of such region (the endorse- (3) The species, breed, and number of ment representing that the veteri- elephants, hippopotami, rhinoceroses, narian signing the health certificate or tapirs to be imported; was authorized to do so), certifying: (4) The purpose of the importation; (1) That the elephant, hippopotamus, (5) The port of embarkation; rhinoceros, or tapir was inspected by (6) The name and concentration of the individual signing the health cer- the pesticide intended to be used to tificate and found free of any treat the elephant, hippopotamus, rhi- ectoparasites not more than 72 hours noceros, or tapir for ectoparasites prior before being loaded on the means of to the animal being transported to the conveyance which transported the ani- United States; mal to the United States; and (7) The mode of transportation; (2) That the elephant, hippopotamus, (8) The route of travel; rhinoceros, or tapir was treated for (9) The port of entry in the United ectoparasites at least 3 days but not States and, if applicable, the address of more than 14 days before being loaded the facility to be provided by the im- on the means of conveyance which porter for inspection, treatment, and transported the animal to the United incineration pursuant to § 93.6 of this States. The animal shall have been part; treated, under the supervision of the (10) The proposed date of arrival in individual signing the health certifi- the United States; and cate, by being thoroughly wetted with (11) The name and address of the per- a pesticide applied with either a spray- son to whom the elephant, hippo- er with a hand-held nozzle, a spray-dip potamus, rhinoceros, or tapir will be machine, or a dip vat; and delivered in the United States. (3) That the elephant, hippopotamus, (d) After receipt and review of the ap- rhinoceros, or tapir, after being treated plication by APHIS, an import permit for ectoparasites in accordance with indicating the applicable conditions paragraph (a)(2) of this section, did not under this part for importation into have physical contact with or share a

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pen or bedding materials with any ele- potamus, rhinoceros, or tapir will be phant, hippopotamus, rhinoceros, or delivered. tapir not in the same shipment to the [52 FR 29502, Aug. 10, 1987; 52 FR 35350, Sept. United States; and 18, 1987, as amended at 57 FR 23049, June 1, (4) The name and concentration of 1992; 59 FR 67615, Dec. 30, 1994. Redesignated the pesticide used to treat the animal and amended at 62 FR 56012, 56021, Oct. 28, (such pesticide and the concentration 1997] used must be adequate to kill the types § 93.805 Ports of entry, inspection, and of ectoparasites likely to infest the treatment. 1 animal to be imported; a list of recommended pesticides and concentra- (a) An elephant, hippopotamus, rhinoceros, or tapir shall be imported into tions may be obtained from the Animal the United States only: and Plant Health Inspection Service, (1) At Los Angeles, California; Veterinary Services, National Center Miami, Florida; and Newburgh, New for Import-Export, 4700 River Road York; or Unit 38, Riverdale, Maryland 20737–1231; (2) On a case-by-case basis, at an- and other port of entry if: (5) The name and address of the con- (i) The animals will be inspected and signor and consignee. treated at a facility provided by the [52 FR 29502, Aug. 10, 1987; 52 FR 35350, Sept. importer; 18, 1987, as amended at 57 FR 23049, June 1, (ii) The Administrator has deter- 1992; 59 FR 67615, Dec. 30, 1994. Redesignated mined that the importer’s facility is and amended at 62 FR 56012, 56021, Oct. 28, adequate for inspection, treatment, 1997] and incineration required under this section; § 93.804 Declaration upon arrival. (iii) The Administrator has deter- Upon arrival of an elephant, hippo- mined that an inspector is available to potamus, rhinoceros, or tapir at a port perform at the importer’s facility the of entry, the importer or the import- services that are required under this er’s agent shall notify APHIS of the ar- section; and rival by giving an inspector a com- (iv) The Administrator has determined that an inspector is available to pleted VS Form 17–29, ‘‘Declaration of perform at the port of entry the serv- Importation for Animals, Animal ices that are required under this sec- Semen, Birds, Poultry, and Eggs for tion if the animals will be inspected Hatching.’’ (This form is available and treated at a facility provided by from the Animal and Plant Health In- the importer. spection Service, Veterinary Services, (b) An elephant, hippopotamus, rhi- National Center for Import-Export, noceros, or tapir shall be entered into 4700 River Road Unit 38, Riverdale, the United States only under the fol- Maryland 20737–1231.) It must state: lowing conditions: (a) The port of entry; (1) Any documents accompanying the (b) The date of arrival; animal shall be subject to inspection (c) The import permit number; by an inspector at the port of entry; (d) The name of the carrier and iden- (2) If the animal is to be moved from tification of the means of conveyance; the port of entry to a facility provided (e) The name and address of the im- by the importer: porter; (i) At the port of entry the animal (f) The name and address of the shall be subject to as much inspection broker; by an inspector as is feasible and shall (g) The region from which the ele- be sprayed or dipped, as feasible, under phant, hippopotamus, rhinoceros, or the supervision of an inspector and tapir was shipped; (h) The number, species, and purpose 1 Importers must also meet all require- of importation of the elephant, hippo- ments of the U.S. Department of the Interior regulations relevant to the importation of potamus, rhinoceros, or tapir; and elephants, hippopotami, rhinoceroses, and (i) The name and address of the per- tapirs, including regulations concerning son to whom the elephant, hippo- ports of entry.

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with a permitted dip listed in § 72.13(b) listed in § 72.13(b) of this chapter for as of this chapter; many times as necessary until the in- (ii) At the port of entry, as much spector finds no ectoparasites; and hay, straw, feed, bedding, and other thereafter the animal shall be sprayed material as can feasibly be removed or dipped one additional time in ac- from the shipping crate or vehicle con- cordance with label instructions with a taining the animal shall be removed, permitted dip listed in § 72.13(b) of this sealed in plastic bags, and incinerated chapter; by the importer under the supervision (4) All hay, straw, feed, bedding, and of an inspector; other material that has been placed (iii) At the port of entry, the ship- with the animal at any time prior to ping crate or the vehicle containing the final treatment referred to in para- the animal shall be sealed by an inspec- graph (b)(3) of this section, and any tor with an official seal of the United plastic sheet used to wrap any shipping States Department of Agriculture: crate, shall be sealed in plastic bags (iv) If the animal is moved from the and incinerated under the supervision port of entry in a shipping crate, plas- of an inspector; tic must be fastened around the ship- (5) Any shipping crate shall be, under ping crate so that all animal waste, hay, straw, feed, bedding, and other the supervision of an inspector, either material accompanying the animal are cleaned and disinfected using a dis- retained inside the crate, but not so as infectant listed in § 71.10 of this chapter to interefere with ventilation, feeding, or incinerated; and if the shipping and watering of the animal; crate is cleaned and disinfected, it (v) After the arrival of the animal at shall then be treated under the super- the facility provided by the importer, vision of an inspector with a permitted the seal shall be broken by an inspec- dip listed in § 72.13(b) of this chapter; tor; (6) Any means of conveyance used to (3) The animal shall be inspected by transport an animal not in a shipping an inspector within 24 hours of being crate shall be, under the supervision of unloaded at the port of entry or at a fa- an inspector, cleaned and disinfected cility provided by the importer, and using a disinfectant listed in § 71.10 of shall be treated under the supervision this chapter and then treated with a of an inspector, as follows: permitted dip listed in § 72.13(b) of this (i) The animal shall be removed from chapter. its shipping crate or cargo hold, placed [52 FR 29502, Aug. 10, 1987, as amended at 57 on a concrete or other nonporous sur- FR 23049, June 1, 1992. Redesignated at 62 FR face, and physically inspected for 56012, Oct. 28, 1997; 65 FR 38178, June 20, 2000] ectoparasites by an inspector. If inspection and treatment are not per- § 93.806 Animals refused entry. formed upon unloading, the animal must be isolated from all other ani- Any elephant, hippopotamus, rhinoc- mals, except those in the same ship- eros, or tapir refused entry into the ment, and kept in a facility with a non- United States for noncompliance with porous floor and where any the requirements of this part shall be ectoparasites that may drop off the removed from the United States within animal can be contained and destroyed, a time period specified by the Adminis- until the animal has been inspected trator or shall be considered abandoned and treated; by the importer, and pending removal (ii) If the inspector finds no or abandonment, the animal shall be ectoparasites, the animal shall be subject to such safeguards as the in- sprayed or dipped one time in accord- spector determines necessary to pre- ance with label instructions with a per- vent the possible introduction of mitted dip listed in § 72.13(b) of this ectoparasites into the United States. If chapter; or such animal is not removed from the (iii) If the inspector finds United States within such time period ectoparasites, the animal shall be or is abandoned, it may be seized, de- sprayed or dipped in accordance with stroyed, or otherwise disposed of as the label instructions with a permitted dip Administrator determines necessary to

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prevent the possible introduction of text otherwise requires, they shall be ectoparasites into the United States. construed, respectively, to mean: Administrator. The Administrator, [52 FR 29502, Aug. 10, 1987, as amended at 57 FR 23049, June 1, 1992. Redesignated at 62 FR Animal and Plant Health Inspection 56012, Oct. 28, 1997] Service, or any person authorized to act for the Administrator. § 93.807 Other importations. Animal and Plant Health Inspection (a) Elephants, hippopotami, rhinoc- Service. The Animal and Plant Health eroses, and tapirs are exempt from the Inspection Service of the United States regulations in this part under the fol- Department of Agriculture (APHIS). lowing circumstances: APHIS representative. A veterinarian (1) They are imported from Canada or other individual employed by the and are accompanied by a document Animal and Plant Health Inspection signed by a salaried veterinarian of the Service, United States Department of Canadian Government that states: Agriculture, who is authorized to perform the services required by this part. (i) They were not imported into Can- ada during the year preceding their im- Certifying official. An individual au- portation into the United States; and thorized by the competent authority of a country to sign health certificates (ii) They did not, during the year pre- for aquatic animals. ceding their importation into the United States, have physical contact Competent authority. The national with or share a pen or bedding mate- veterinary services or other authority rials with any elephant, hippopotamus, of a country, having the responsibility rhinoceros, or tapir imported into Can- and competence for ensuring or super- ada during that year; or vising the implementation of aquatic animal health measures. (2) They were exported into Canada from the United States and then im- Container. A transport receptacle ported back into the United States ac- that is specially constructed to facili- companied by a United States health tate transportation of aquatic animals certificate. or aquatic animal products by one or several means of transport. (b) Notwithstanding other provisions in this part, the Administrator may in Department. The United States De- specific cases allow the importation partment of Agriculture (USDA). and entry of elephants, hippopotami, Fertilized egg. A viable fertilized rhinoceroses, or tapirs into the United ovum of an aquatic animal. States other than as provided for in Gamete. The sperm or unfertilized egg this part under such conditions as the of aquatic animals that is held or Administrator may prescribe to pre- transported separately. vent the introduction of ectoparasites Inspector. An employee of the Animal into the United States. and Plant Health Inspection Service authorized to perform duties required (Approved by the Office of Management and under this subpart. Budget under control number 0579–0020) Person. Any individual, corporation, [52 FR 29502, Aug. 10, 1987; 52 FR 35350, Sept. company, association, firm, partner- 18, 1987, as amended at 57 FR 23049, June 1, ship, society or joint stock company. 1992; 59 FR 67133, Dec. 29, 1994. Redesignated Port veterinarian. A veterinarian em- at 62 FR 56012, Oct. 28, 1997, as amended at 64 ployed by the Animal and Plant Health FR 23179, April 30, 1999] Inspection Service to perform duties required under this subpart at a port of Subpart I—Aquatic Animal entry. Species Region. Any defined geographic land area identifiable by geological, polit- SOURCE: 71 FR 51435, Aug. 30, 2006, unless ical, or surveyed boundaries. A region otherwise noted. may consist of any of the following: (1) A national entity (country); § 93.900 Definitions. (2) Part of a national entity (zone, Wherever in this subpart the fol- county, department, municipality, par- lowing terms are used, unless the con- ish, Province, State, etc.);

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(3) Parts of several national entities whose care is partly or totally managed from combined into an area; or the first life stage onwards. (4) A group of national entities (countries) combined into a single area. * * * * * Spring viremia of carp (SVC). A disease Secure water source. A biosecure water sup- caused by infection with spring viremia ply that does not contain pathogens or has of carp virus, a rhabodivrus capable of not had the opportunity to be contaminated infecting several carp species, in addi- with pathogens. Biosecure water supplies in- tion to some other cyprinid and clude well, spring, or borehole water; surface ictalurid fish species. water that does not contain fish populations; SVC-susceptible species. Common carp or water that has been treated to eliminate (Cyprinus carpio), grass carp aquatic animal pathogens. (Ctenopharyngodon idellus), silver carp (Hypophthalmichthys molitrix), bighead * * * * * carp (Aristichthys nobilis), Crucian carp VHS-regulated fish. Any fish species listed (Carassius carassius), goldfish (Carassius in accordance with § 93.910. auratus), tench (Tinca tinca), and VHS-regulated region. Any region listed in sheatfish (Silurus glanis). accordance with § 93.910. United States. All of the States of the VHS virus. Any North American (type IV) United States, the District of Colum- strain of VHS virus, a rhabdovirus of fish. bia, Guam, Northern Mariana Islands, Viral hemorrhagic septicemia (VHS). A dis- Puerto Rico, the Virgin Islands of the ease caused by infection with VHS virus. United States, and all other territories GENERAL PROVISIONS FOR SVC- and possessions of the United States. REGULATED FISH SPECIES EFFECTIVE DATE NOTE: At 73 FR 52186, Sept. 9, 2008, § 93.900 was amended by adding EFFECTIVE DATE NOTE: At 73 FR 52186, definitions, effective Nov. 10, 2008. At 73 FR Sept. 9, 2008, subpart I was amended by add- 63867, Oct. 28, 2008, the effective date was de- ing an undesignated center heading pre- layed until Jan. 9, 2009. At 74 FR 1, Jan. 2, ceding § 93.901, effective Nov. 10, 2008. At 73 2009, the effective date was delayed indefi- FR 63867, Oct. 28, 2008, the effective date was nitely. For the convenience of the user, the delayed until Jan. 9, 2009. At 74 FR 1, Jan. 2, added text is set forth as follows: 2009, the effective date was delayed indefinitely. § 93.900 Definitions. § 93.901 General restrictions; excep- * * * * * tions. Anadromous fish. Fish that are born and (a) No live fish, fertilized eggs, or spawn in freshwater, but which spend part of gametes of SVC-susceptible species their lifecycle in saltwater. may be imported into the United States except in accordance with this * * * * * subpart, 11 nor shall any such live fish, Approved laboratory. A laboratory author- fertilized eggs, or gametes be moved ized by the competent authority of a country from the port of entry after arrival for aquatic animal health to perform assays until released by the port veterinarian; for the detection of VHS virus. provided that the Administrator may, Catch-and-release fishing. Fishing for pleas- upon request in specific cases, allow ure or for recreational purposes, including the importation of SVC-susceptible tournaments, organized fishing competi- live fish, fertilized eggs, or gametes tions, fishing derbies, or other types of contests where individuals catch, compare, and under conditions other than those set release live VHS-regulated fish. This term excludes VHS-regulated fish used, or in- 11 The importation of live cultures of SVC tended to be used, as live bait. virus, preserved SVC virus viral RNA or DNA, tissue samples containing viable SVC * * * * * virus, or other specimens intended for diagnostic or research purposes and which con- Cultured fish. Fish of the same species and tain viable SVC virus may be imported only age class, originating from the same under permit in accordance with 9 CFR part broodstock and on the same water supply, 122.

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forth in this subpart when the Admin- tion against environmental conditions istrator determines that such move- and so that it can be adequately ment will not result in the introduc- cleaned, washed and disinfected; tion of SVC into the United States. (iii) Provision must be made for dis- (b) Other provisions of this subpart posal of fish carcasses, shipping water, relating to the importation of live fish, waste and any associated shipping ma- fertilized eggs, and gametes shall not terials in a manner that will prevent apply to shipments of SVC-susceptible dissemination of disease; species of live fish, fertilized eggs, or (iv) Provision must be made for ade- gametes in transit through the United quate sources of feed and water and for States if an import permit has been ob- attendants for the care and feeding of tained under § 93.903 and all conditions live fish, fertilized eggs, or gametes in of the permit are observed; and if the the facility; live fish, fertilized eggs, and gametes (v) The holding facility must comply are handled as follows: with all applicable local, State and (1) They are maintained under con- Federal requirements for environ- tinuous confinement while in transit mental quality. through the United States aboard an (vi) The holding facility must comply aircraft, ocean vessel, or other means with any additional requirements that of conveyance; or may be imposed by the Administrator (2) They are unloaded, in the course for a particular shipment if necessary of such transit, into a holding facil- to prevent the dissemination of dis- ity 12 that is provided by the carrier or ease. its agent and has been approved by the (Approved by the Office of Management and Administrator in accordance with Budget under control number 0579–0301) paragraph (b)(4) of this section as ade- [71 FR 51435, Aug. 30, 2006; 71 FR 54552, Sept. quate to prevent the spread within the 15, 2006] United States of any finfish disease; they are maintained there under con- § 93.902 Ports designated for the im- tinuous confinement until loaded portation of live fish, fertilized aboard a means of conveyance for eggs, and gametes. transportation from the United States; (a) The following ports are des- and are maintained under continuous ignated as ports of entry for live fish, confinement aboard such means of con- fertilized eggs, and gametes of SVC- veyance until it leaves the United susceptible species imported under this States. subpart: (3) They are moved in accordance (1) Air and ocean ports. Los Angeles with any additional conditions pre- and San Francisco, CA; Miami and scribed in the permit and determined Tampa, FL; Atlanta, GA; Honolulu, HI; by the Administrator to be necessary Chicago, IL; Boston, MA; Newark, NJ; to ensure that the live fish, fertilized New York, NY; Portland, OR; Dallas- eggs, or gametes through the United Ft. Worth, TX; and San Juan, PR. States do not introduce SVC into the (2) Canadian border ports. Detroit, MI; United States. Buffalo-Niagara, NY; and Blaine and (4) For a holding facility to be ap- Seattle, WA. proved by the Administrator: (3) Mexican border ports. Otay Mesa, (i) The holding facility must be suffi- CA. ciently isolated to prevent direct or in- (b) Designation of other ports. Other direct contact of the live fish, fertilized ports may be designated by the Admin- eggs, or gametes it contains with any istrator in specific cases with the con- other SVC-susceptible species in the currence of the Secretary of the De- United States; partment of Homeland Security. (ii) The holding facility must be constructed to provide adequate protec- § 93.903 Import permits for live fish, fertilized eggs, and gametes.

12 Requests for approval of such facilities (a) Live fish, fertilized eggs, or should be made to the Animal and Plant gametes of SVC-susceptible species im- Health Inspection Service at the address pro- ported into the United States must be vided in § 93.903 for permit applications. accompanied by an import permit

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issued by APHIS and must be imported § 93.904 Health certificate for live fish, within 30 days after the proposed date fertilized eggs, and gametes. of arrival stated in the import permit. (a) General. All live fish, fertilized (b) An application for an import per- eggs, and gametes of SVC-susceptible mit must be submitted for each ship- species that are imported from any re- ment of live fish, fertilized eggs, or gion of the world must be accompanied gametes of SVC-susceptible species to by a health certificate issued by a full- the Animal and Plant Health Inspec- time salaried veterinarian of the nation Service, Veterinary Services, Na- tional government of the exporting re- tional Center for Import and Export, gion, or issued by a certifying official 4700 River Road Unit 38, Riverdale, MD and endorsed by the competent author- 20737–1231. Application forms for im- ity of that country. The health certifi- port permits may be obtained from this cate must be written in English or con- address. tain an English translation. The health (c) A completed application shall in- certificate will be valid for 30 days clude the following information: from the date of issuance. The health (1) The name and address of the per- certificate for the live fish, fertilized son intending to export live fish, fer- eggs, or gametes must state that: tilized eggs, or gametes of SVC-suscep- (1) The live fish, fertilized eggs, or tible species to the United States; gametes were inspected by the veteri- (2) The proposed date of shipment to narian or certifying official who issued the United States; the certificate within 72 hours prior to (3) The name and address of the per- shipment, and were found to be free of son intending to import live fish, fer- any clinical signs of disease consistent tilized eggs, or gametes of SVC-suscep- with SVC; and tible species into the United States; (2) The live fish, fertilized eggs, or (4) The species and number of live gametes covered by the health certifi- fish, fertilized eggs, or gametes of SVC- cate meet the requirements of this sec- susceptible species to be imported into tion. the United States; (b) Surveillance. The live fish, fer- (5) The purpose of the importation; tilized eggs, or gametes must meet the (6) The port of embarkation; following conditions to be eligible for (7) The mode of transportation; importation into the United States: (8) The route of travel, including all (1) The live fish, fertilized eggs, or carrier stops en route; gametes must originate in a region or (9) The port of entry in the United establishment which conducts a sur- States; veillance program for SVC under the (10) The proposed date of arrival in supervision of the competent author- the United States; and ity. (11) The name and address of the per- (2) The region or establishment must son to whom the live fish, fertilized demonstrate freedom from SVC eggs, or gametes of SVC-susceptible through a minimum of 2-years’ contin- species will be delivered in the United uous health history, supported by lab- States. oratory testing by a pathogen detec- (d) If APHIS determines that the live tion facility approved for SVC viral as- fish, fertilized eggs, or gametes are eli- says by the competent authority. gible for importation, APHIS will issue (3) SVC-susceptible fish populations an import permit indicating the appli- in the region or establishment must be cable conditions for importation. An tested at least twice annually, with at import permit does not guarantee that least 3 months between the tests and at any live fish, fertilized eggs, or times or under environmental condi- gametes will be allowed entry into the tions that would facilitate the detec- United States; the fish, fertilized eggs, tion of SVCV if it were present. Sam- or gametes will be allowed to enter the pling procedures must utilize an as- United States only if they meet all ap- sumed pathogen prevalence of 2 per- plicable requirements of the permit cent, with a corresponding confidence and regulations. level of 95 percent. Samples must be (Approved by the Office of Management and collected and submitted by a certifying Budget under control number 0579–0301) official or veterinarian recognized by

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the competent authority. The standard § 93.905 Declaration and other docu- screening method for SVC must include ments for live fish, fertilized eggs, isolation of SVCV in cell culture, using and gametes. either the epithelioma papulosum (a) For all live fish, fertilized eggs, cyprini (EPC) or fathead minnow and gametes offered for importation (FHM) cell lines. However, the Admin- under this subpart, the importer or his istrator may authorize other assays for or her agent must submit the following SVCV detection in lieu of virus isola- documents to the collector of customs tion through cell culture, if the Admin- for use by the port veterinarian: istrator determines that such assays (1) All permits, certificates, or other provide equivalent assurance of the documentation required by this sub- SVC status of an exporting region or part; and establishment. All viral testing results (2) Two copies of a declaration that must be negative. lists the port of entry, the name and (c) Shipping containers. All live fish, address of the importer, the name and fertilized eggs, and gametes must be address of the broker, the origin of the shipped to the United States in new live fish, fertilized eggs, or gametes, containers or in used containers that the number, species, and the purpose of have been cleaned and disinfected in the importation, the name of the per- accordance with this section. son to whom the fish will be delivered, (1) Cleaning and disinfection of ship- and the location of the place to which ping containers must take place under such delivery will be made. the supervision of the veterinarian or (b) [Reserved] certifying official who issues the health certificate. (Approved by the Office of Management and Budget under control number 0579–0301) (2) Cleaning and disinfection must be sufficient to neutralize any SVC virus § 93.906 Inspection at the port of to which shipping containers may have entry. been exposed. Acceptable disinfection (a) All live fish, fertilized eggs, and procedures include individual or com- gametes of SVC-susceptible species im- bination treatments with: Solutions ported from any part of the world must having a pH of 12 or higher or 3 or be presented for inspection at a port of lower with a contact time of at least 10 entry designated under § 93.902. The ° minutes; heat at or above 56 C for at APHIS port veterinarian must be noti- least 15 minutes; chlorine solutions fied at least 72 hours in advance of the having a concentration of at least 500 arrival in the United States of a ship- ppm with a contact time of at least 10 ment of live fish, fertilized eggs, or minutes; iodine solutions having a con- gametes of SVC-susceptible species. centration of at least 100 ppm with a Any shipment of live SVC-susceptible contact time of at least 10 minutes; ul- fish species that the port veterinarian traviolet exposure (254 nm; min expo- determines to exhibit clinical signs sure of 10,000 microwatt seconds/cm2); consistent with SVCV infection or dis- or other disinfectants such as Virkon ease, or any shipments of live fish, fer- used according to the manufacturer’s tilized eggs, and gametes of SVC-sus- directions. The Administrator may au- ceptible species that otherwise do not thorize other procedures if the Admin- meet the requirements of this subpart, istrator determines they are adequate shall be refused entry. to neutralize the SVC virus. (b) Shipments refused entry, unless (3) Cleaning and disinfection proto- exported within a time fixed in each cols must be referenced in the health case by the Administrator, and in ac- certificate or in a separate cleaning cordance with other provisions he or and disinfection certificate accom- she may require in each case for their panying the shipment to the U.S. port handling, shall be disposed of as the of entry. Administrator may direct. (Approved by the Office of Management and (Approved by the Office of Management and Budget under control number 0579–0301) Budget under control number 0579–0301)

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§§ 93.907–93.909 [Reserved] strain type IV(a) has been isolated will not be considered VHS-regulated fish. EFFECTIVE DATE NOTE: At 73 FR 52186, (2) If APHIS determines that, in ac- Sept. 9, 2008, §§ 93.907 through 93.909 were cordance with the criteria in paragraph added and reserved, effective Nov. 10, 2008. At (b)(1) of this section, a species should 73 FR 63867, Oct. 28, 2008, the effective date was delayed until Jan. 9, 2009. At 74 FR 1, be added to the list of VHS-regulated Jan. 2, 2009, the effective date was delayed species, APHIS will publish a notice in indefinitely. the FEDERAL REGISTER announcing that determination. GENERAL PROVISIONS FOR VHS- (c)(1) APHIS will list as a VHS-regu- REGULATED FISH SPECIES lated region any region in which VHS virus has been officially reported to the SOURCE: 73 FR 52186, Sept. 9, 2008, unless World Health Organization for Animal otherwise noted. Health by the country’s competent au- EFFECTIVE DATE NOTE: At 73 FR 52186, thority for aquatic animal health from Sept. 9, 2008, an undesignated center heading any fish species in a water source that and new §§ 93.910 through 93.916 were added to is not a secure water source, or which subpart I after the newly reserved §§ 93.907 the Administrator determines to be at through 93.909, effective Nov. 10, 2008. At 73 risk of having VHS based on criteria FR 63867, Oct. 28, 2008, the effective date was delayed until Jan. 9, 2009. At 74 FR 1, Jan. 2, such as inadequate surveillance, less 2009, the effective date was delayed indefi- restrictive import requirements, or nitely. other epidemiologic information. (2) If the Administrator determines § 93.910 General restrictions; excep- that a region meets the criteria in tions. paragraph (c)(1) of this section, APHIS (a) No live VHS-regulated species of will publish a notice of its decision in fish may be imported into the United the FEDERAL REGISTER and take com- States from VHS-regulated regions ex- ments from the public. The designation cept in accordance with this subpart or as a VHS-regulated region will become the regulations of the U.S. Fish and effective upon publication of this no- Wildlife Service (FWS) in 50 CFR tice. After reviewing the comments, 16.13(a)(3) and 16.13(b), nor may such APHIS will issue a second notice in the live VHS-regulated fish be moved from FEDERAL REGISTER announcing its de- the port of entry after arrival until re- cision on whether or not the designa- leased by an APHIS representative or tion as a VHS-regulated region will re- FWS official; Provided, that the Admin- main in effect. istrator may, upon request in specific (d) APHIS maintains the lists of cases, allow the importation of live VHS-regulated fish and VHS-regulated VHS-regulated fish into the United regions on the APHIS aquaculture Web States under conditions other than site at http://www.aphis.usda.gov/ those specifically set forth in this sub- animallhealth/animalldislspec/aqua- part when the Administrator deter- culture. The lists may be obtained from mines that such movement will not re- the Animal and Plant Health Inspec- sult in the further introduction of VHS tion Service, Veterinary Services, Na- into the United States. tional Aquaculture Program, 4700 River (b)(1) APHIS will list as a VHS-regu- Road Unit 46, Riverdale, MD 20737–1231. lated fish any fish species found in (e) Other provisions of this subpart freshwater to be susceptible to the relating to the importation of live North American (type IV) strain of VHS-regulated fish shall not apply to VHS virus under natural (i.e., non-con- shipments of such fish imported from trolled) conditions of exposure and VHS-regulated regions if they are im- from which VHS virus has been iso- ported in accordance with the FWS lated in cell culture or other assay de- regulations in 50 CFR 16.13. termined by the competent authority (f) Other provisions of this subpart to be adequate to detect VHS virus, relating to the importation of live with confirmation of strain identity VHS-regulated fish shall not apply to through genetic sequencing. Anad- shipments of such fish in transit romous fish species that have migrated through the United States, if an import into freshwater and from which VHS permit has been obtained under § 93.912

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and all conditions of the permit are ob- (g) Other provisions of this subpart served, and if the live VHS-regulated relating to the importation of live fish species are handled as follows: VHS-regulated fish shall not apply to (1) They are maintained under con- fish moved into the United States from tinuous confinement while in transit VHS-regulated regions during catch- through the United States aboard an and-release fishing. aircraft, ocean vessel, or other means of conveyance; or, if they are unloaded § 93.911 Ports designated for the im- in the course of such transit, they are portation of live VHS-regulated fish placed in a holding facility that is pro- species. vided by the carrier or its agent and (a) Live VHS-regulated fish from has been approved by the Adminis- VHS-regulated regions may be im- trator as adequate to prevent the ported into the United States without spread within the United States of any an import permit through the fol- finfish disease; they are maintained lowing Canadian border ports: there under continuous confinement Eastport, ID; Houlton and Jackman, until loaded aboard a means of convey- ME; Detroit, Port Huron, and Sault ance for transportation from the Ste. Marie, MI; Baudette, MN; Opheim, United States; and they are maintained Raymond, and Sweetgrass, MT; Alex- under continuous confinement aboard andria Bay, Buffalo, and Champlain, such means of conveyance until it NY; Dunseith, Pembina, and Portal, leaves the United States. ND; Derby Line and Highgate Springs, (2) They are moved in accordance VT; and Oroville and Sumas, WA. with any additional conditions pre- (b) Live VHS-regulated fish may be scribed in the permit that the Adminis- imported into the United States with trator has determined to be necessary an import permit through the fol- to ensure that the fish do not introduce lowing ports: Anchorage, AK; Los An- VHS into the United States. geles and San Francisco, CA; Miami (3) For a holding facility to be ap- and Tampa, FL; Atlanta, GA; Hono- proved by the Administrator, the fol- lulu, HI; Chicago, IL; Boston, MA; New- lowing conditions must be met: ark, NJ; Jamaica and Newburgh, NY; (i) The holding facility must be suffi- Portland, OR; Memphis, TN; Dallas-Ft. ciently isolated to prevent direct or in- Worth, TX; Seattle, WA; and San Juan, direct contact of the live fish it con- PR. tains with any other live VHS-regulated fish species in the United States. (c) Designation of other ports. Other (ii) The holding facility must be con- ports may be designated by the Admin- structed to provide adequate protec- istrator in specific cases with the con- tion against environmental conditions currence of the Secretary of the De- and so that it can be adequately partment of Homeland Security. cleaned, washed, and disinfected. § 93.912 Import permits. (iii) Provision must be made for disposal of fish carcasses, shipping water, (a) Live VHS-regulated fish imported effluent, waste, and any associated from VHS-regulated regions through a shipping materials in a manner that limited port as described in § 93.911(b) will prevent dissemination of disease. must be accompanied by an import per- (iv) Provision must be made for ade- mit issued by APHIS and must be im- quate sources of feed and water and for ported within 30 days of the proposed attendants for the care and feeding of arrival date stated in the import per- fish in the facility. mit. (v) The holding facility must comply (b) An application for an import per- with all applicable local, State, and mit must be submitted for each ship- Federal requirements for environment of live VHS-regulated fish to the mental quality. Animal and Plant Health Inspection (vi) The holding facility must comply Service, Veterinary Services, National with any additional requirements that Center for Import and Export, 4700 the Administrator may impose on a River Road Unit 38, Riverdale, MD particular shipment in order to prevent 20737–1231. Application forms for im- the dissemination of disease. port permits may be obtained from this

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address. Applications may also be ob- an English translation. The health cer- tained from the following APHIS Web tificate will be valid for 30 days from site: http://www.aphis.usda.gov/vs/ncie/ the date of issuance. The health certifi- pdf/vs17-129.pdf. cate for the live VHS-regulated fish (c) A completed application must in- must state that: clude the following information: (1) The live fish were inspected by the (1) The name and address of the per- veterinarian or certifying official who son intending to export live VHS-regu- issued the certificate within 72 hours lated fish to the United States; prior to shipment, and were found to be (2) The proposed date of shipment to free of any clinical signs of disease con- the United States; sistent with VHS; and (3) The name and address of the per- (2) The live fish covered by the health son intending to import live VHS-regu- certificate originated in a region or fa- lated fish into the United States; cility that has demonstrated freedom (4) The species and number of live from VHS through testing in accord- VHS-regulated fish to be imported into ance with paragraphs (b) and (c) of this the United States; section. (5) The purpose of the importation; (b) Testing. A facility can dem- (6) The port of embarkation; onstrate freedom from VHS through (7) The mode of transportation; negative testing results by a pathogen (8) The route of travel, including all detection laboratory approved for VHS carrier stops en route; viral assays by the competent author- (9) The port of entry in the United ity of that country. Testing must meet States; the following conditions: (10) The proposed date of arrival in (1) Testing must be conducted with a the United States; and testing sample size that provides for a (11) The name and address of the per- 95 percent confidence level of detecting son to whom the live VHS-regulated a 2 percent prevalence of infection in fish will be delivered in the United the facility. States. (i) Facilities with cultured fish of (d) If APHIS determines that the live VHS-regulated species which can docu- VHS-regulated fish from VHS-regu- ment a 2-year history of negative test- lated regions are eligible for importa- ing for VHS virus can conduct testing tion, APHIS will issue an import per- at a sampling level to provide a 95 permit indicating the applicable condi- cent confidence level of detecting a 5 tions for importation. An import per- percent prevalence of infection in the mit does not guarantee that any live facility. Such testing must be con- VHS-regulated fish will be allowed ducted twice a year, with at least 3 entry into the United States; the VHS- months between tests. regulated fish will be allowed to enter (ii) Facilities with cultured fish of the United States only if they meet all VHS-regulated species which can docu- applicable requirements of the permit ment a 4-year history of negative test- and regulations. ing for VHS virus can conduct testing (Approved by the Office of Management and at a sampling level to provide a 95 per- Budget under control number 0579–0340) cent confidence level of detecting a 10 percent prevalence of infection in the § 93.913 Health certificate. facility. Such testing must be con- (a) General. All live VHS-regulated ducted twice a year, with at least 3 fish that are imported from VHS-regu- months between tests. lated regions for other than immediate (iii) Such facilities must be on a se- slaughter or research or laboratory use cure water source, and document that must be accompanied by a health cer- any VHS-regulated species in the facil- tificate issued by a full-time salaried ity that originated in VHS-regulated veterinarian of the national govern- States or Canadian provinces originate ment of the exporting country, or from facilities of the same or higher issued by a certifying official and en- health status. dorsed by the competent authority of (2) Tests must include virus isolation that country. The health certificate or other assays authorized by the com- must be written in English or contain petent authority, using appropriate

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cell lines to detect VHS virus, if Protection officer for use by the port present. All suspect VHS cytopathic ef- veterinarians: fects must be positively identified as (1) All permits, certificates, or other VHS through molecular assays and/or documentation required under §§ 93.912 genetic sequencing. and 93.913; and (3) Proportional numbers of each (2) Two copies of a declaration that VHS-regulated fish species which lists the port of entry; the name and might be present in a shipment must address of the importer; the name and be used for testing, if applicable. address of the broker; the origin of the (4) Testing must be conducted at live fish; the number, species, and the water temperatures between 50 and 72 purpose of the importation; the name ° F, or at other times or under environ- of the person to whom the fish will be mental conditions when VHS virus is delivered; and the location of the place most likely to be detected, if present. to which such delivery will be made. (c) When APHIS adds a new species (b) [Reserved] to the list of VHS-regulated species after a facility has been determined to (Approved by the Office of Management and be free of VHS in accordance with para- Budget under control number 0579–0340) graph (b) of this section, the facility must conduct additional testing on fish § 93.915 Inspection at the port of of the newly listed species, if present in entry. the facility, and the fish must be free (a) Shipments of live VHS-regulated of VHS virus for the facility to retain fish must be presented for inspection at its free status. VHS testing must be a port of entry designated under conducted on each newly listed species § 93.911. For live fish entering through a with a sample size that provides for a limited port listed in § 93.911(c), the 95 percent confidence level of detecting APHIS port veterinarian must be noti- a 2 percent prevalence of infection in fied at least 72 hours in advance of the the fish facility. arrival in the United States of the (d) Shipping containers. Except as pro- shipment. Any shipment that does not vided in § 93.910(e)–(g), all live fish that meet the requirements of this subpart are to be shipped to the United States will be refused entry. must be shipped in new containers or (b) Shipments refused entry must be in containers that have been cleaned exported within a time fixed in each and disinfected. case by the Administrator, and in ac- (1) Cleaning and disinfection of ship- cordance with other provisions he or ping containers must be monitored by she may require in each case for their the veterinarian or certifying official handling, or the shipment will be dis- who issues the health certificate. posed of as the Administrator may di- (2) Cleaning and disinfection must be rect. sufficient to neutralize any VHS virus to which shipping containers may have (Approved by the Office of Management and been exposed. Budget under control number 0579–0340) (3) The cleaning and disinfection protocols used must be referenced in the § 93.916 Special provisions. health certificate or in a separate (a) Slaughter. Live VHS-regulated fish cleaning and disinfection certificate from VHS-regulated regions may be accompanying the shipment to the U.S. imported directly for slaughter under port of entry. the following conditions: (Approved by the Office of Management and (1) An import permit has been ob- Budget under control number 0579–0340) tained under § 93.912 and all conditions of the permit are observed. § 93.914 Declaration and other docu- (2) An APHIS representative at the ments. port seals the means of conveyance (a) For live VHS-regulated fish of- with official seals. fered for importation under this sub- (3) The shipment is moved directly part, the importer or his or her agent from the port of entry to a slaugh- must submit the following documents tering establishment that meets the to the appropriate Customs and Border following conditions:

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(i) The slaughtering establishment PART 94—RINDERPEST, FOOT-AND- discharges its waste water to a munic- MOUTH DISEASE, EXOTIC NEW- ipal sewage system that includes waste CASTLE DISEASE, AFRICAN SWINE water disinfection sufficient to neu- FEVER, CLASSICAL SWINE FEVER, tralize any VHS virus or to either a SWINE VESICULAR DISEASE, AND non-discharging settling pond or a settling pond that disinfects, according to BOVINE SPONGIFORM all applicable local, State, and Federal ENCEPHALOPATHY: PROHIBITED regulations, sufficiently to neutralize AND RESTRICTED IMPORTATIONS any VHS virus. Sec. (ii) Offal, including carcasses, from 94.0 Definitions. the slaughtering establishment is ei- 94.1 Regions where rinderpest or foot-and- ther rendered or composted. mouth disease exists; importations pro- (4) An APHIS representative will hibited. unseal the vehicle upon arrival at the 94.2 Fresh (chilled or frozen) products slaughtering establishment. (other than meat), and milk and milk products of ruminants and swine. (5) Any water used to transport the 94.3 Organs, glands, extracts, or secretions fish is disposed to a municipal sewage of ruminants or swine. system that includes waste water dis- 94.4 Cured or cooked meat from regions infection sufficient to neutralize any where rinderpest or foot-and-mouth dis- VHS virus or to either a non-disease exists. 94.5 Regulation of certain garbage. charging settling pond or a settling 94.6 Carcasses, meat, parts or products of pond that disinfects, according to all carcasses, and eggs (other than hatching applicable local, State, and Federal eggs) of poultry, game birds, or other regulations, sufficiently to neutralize birds; importations from regions where any VHS virus. exotic Newcastle disease or highly patho- (b) Research or laboratory use. Live genic avian influenza is considered to exist. VHS-regulated fish may be imported 94.7 Disposal of animals, meats, and other from a VHS-regulated region for re- articles ineligible for importation. search or laboratory use under the fol- 94.8 Pork and pork products from regions lowing conditions: where African swine fever exists or is (1) An import permit has been ob- reasonably believed to exist. 94.9 Pork and pork products from regions tained under § 93.912 and all conditions where classical swine fever exists. of the permit are observed. 94.10 Swine from regions where classical (2) The laboratory or research facil- swine fever exists. ity disposes of effluent to a municipal 94.11 Restrictions on importation of meat sewage system that includes waste and other animal products from specified water disinfection sufficient to neu- regions. 94.12 Pork and pork products from regions tralize any VHS virus or to either a where swine vesicular disease exists. non-discharging settling pond or a set- 94.13 Restrictions on importation of pork or tling pond that disinfects, according to pork products from specified regions. all applicable local, State, and Federal 94.14 Swine from regions where swine vesic- regulations, sufficiently to neutralize ular disease exists; importations prohibited. any VHS virus. 94.15 Animal products and materials; move- (3) Carcasses must be rendered or ment and handling. composted. 94.16 Milk and milk products. (4) Any water used to transport the 94.17 Dry-cured pork products from regions fish is disposed to a municipal sewage where foot-and-mouth disease, rinderpest, African swine fever, classical swine system that includes waste water dis- fever, or swine vesicular disease exists. infection sufficient to neutralize any 94.18 Restrictions on importation of meat VHS virus or to either a non-dis- and edible products from ruminants due charging settling pond or a settling to bovine spongiform encephalopathy. pond that disinfects, according to all 94.19 Restrictions on importation from BSE applicable local, State, and Federal minimal-risk regions of meat and edible products from ruminants. regulations, sufficiently to neutralize 94.20 Gelatin derived from horses or swine, any VHS virus. or from ruminants that have not been in

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any region where bovine spongiform the area to be added in accordance with encephalopathy exists. § 92.2 of this subchapter and finds that 94.21 [Reserved] the risk profile for the area is equiva- 94.22 Restrictions on importation of beef lent with respect to classical swine from Uruguay. 94.23 Importation of poultry meat and other fever to the risk profile for the region poultry products from Sinaloa and So- it is joining. nora, Mexico. Authorized inspector. Any individual 94.24 Restrictions on the importation of authorized by the Administrator of pork, pork products, and swine from the APHIS or the Commissioner of Cus- APHIS-defined European CSF region. toms and Border Protection, Depart- 94.25 Restrictions on the importation of live ment of Homeland Security, to enforce swine, pork, or pork products from certain regions free of classical swine fever. the regulations in this part. 94.26 Restrictions on importation of live Birds. All members of the class Aves poultry, poultry meat, and other poultry (other than poultry or game birds). products from specified regions. Bovine. Bos taurus, Bos indicus, and 94.27 Importation of whole cuts of boneless Bison bison. beef from Japan. Bovine spongiform encephalopathy AUTHORITY: 7 U.S.C. 450, 7701–7772, 7781–7786, (BSE) minimal-risk region. A region that: and 8301–8317; 21 U.S.C. 136 and 136a; 31 U.S.C. (1) Maintains, and, in the case of re- 9701; 7 CFR 2.22, 2.80, and 371.4. gions where BSE was detected, had in place prior to the detection of BSE in § 94.0 Definitions. an indigenous ruminant, risk mitiga- As used in this part, the following tion measures adequate to prevent terms shall have the meanings set widespread exposure and/or establish- forth in this section. ment of the disease. Such measures in- Administrator. The Administrator, clude the following: Animal and Plant Health Inspection (i) Restrictions on the importation of Service, or any person authorized to animals sufficient to minimize the pos- act for the Administrator. sibility of infected ruminants being im- Animal and Plant Health Inspection ported into the region, and on the im- Service. The Animal and Plant Health portation of animal products and ani- Inspection Service, of the United mal feed containing ruminant protein States Department of Agriculture sufficient to minimize the possibility (APHIS.) of ruminants in the region being ex- APHIS representative. An individual posed to BSE; employed by Animal and Plant Health (ii) Surveillance for BSE at levels Inspection Service, United States De- that meet or exceed recommendations partment of Agriculture, who is au- of the World Organization for Animal thorized to perform the function in- Health (Office International des volved. Epizooties) for surveillance for BSE; APHIS-defined European CSF region. A and single region of Europe recognized by (iii) A ruminant-to-ruminant feed APHIS as low risk for classical swine ban that is in place and is effectively fever. enforced. (1) A list of areas included in the re- (2) In regions where BSE was de- gion is maintained on the APHIS Web tected, conducted an epidemiological site at http://www.aphis.usda.gov/ investigation following detection of importlexport/animals/ BSE sufficient to confirm the adequacy animalldiseaselstatus.shtml. Copies of of measures to prevent the further in- the list will also be available via postal troduction or spread of BSE, and con- mail, fax, or email upon request to the tinues to take such measures. Sanitary Trade Issues Team, National (3) In regions where BSE was de- Center for Import and Export, Veteri- tected, took additional risk mitigation nary Services, Animal and Plant measures, as necessary, following the Health Inspection Service, 4700 River BSE outbreak based on risk analysis of Road Unit 38, Riverdale, Maryland the outbreak, and continues to take 20737. such measures. (2) APHIS will add an area to the re- Cervid. All members of the family gion after it conducts an evaluation of Cervidae and hybrids, including deer,

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elk, moose, caribou, reindeer, and re- and Inspection Service, United States lated species. Department of Agriculture, to perform Cold spot. The area in a flexible plas- the function involved. tic cooking tube or other type of con- Game birds. Migratory birds, includ- tainer loaded with meat product, or the ing certain ducks, geese, pigeons, and areas at various points along the belt doves (‘‘migratory’’ refers to seasonal in an oven chamber, slowest to reach flight to and from the United States); the required temperature during the free-flying quail, wild grouse, wild cooking process. The cold spot(s) for pheasants (as opposed to those that are each container is experimentally deter- commercial, domestic, or pen-raised). mined before the cooking process be- House. A structure, enclosed by walls gins, and once identified, remains con- and a roof, in which poultry are raised. stant. Immediate export. The period of time Contact. Known or potential commin- determined by APHIS, based on ship- gling of products during processing or ping routes and timetables, to be the storage, or while being transported shortest practicable interval of time from any point to any other point. between the arrival in the United Contact includes the simultaneous processing in the same room, locker, or States of an incoming carrier and the container, but not necessarily the same departure from the United States of an storage facility or conveyance, as long outgoing carrier, to transport a con- as adequate security measures are signment of products. taken to prevent commingling, as de- Import (imported, importation) into the termined by an authorized APHIS rep- United States. To bring into the terri- resentative. torial limits of the United States. Container. For the purposes of § 94.1(c) Indicator piece. A cube or slice of and § 94.16(c), this term means a recep- meat to be used for the pink juice test, tacle, sometimes refrigerated, which is required to meet minimum size speci- designed to be filled with cargo, sealed, fications. and then moved, without unsealing or Operator. The operator responsible unloading, aboard a variety of different for the day-to-day operations of a facil- transporting carriers. ity. Department. The United States De- Personal use. Only for personal con- partment of Agriculture (USDA, De- sumption or display and not distrib- partment). uted further or sold. Direct transloading. The transfer of Pink juice test. Determination of cargo directly from one means of con- whether meat has been thoroughly veyance to another. cooked by observation of whether the Exotic Newcastle disease (END). Any flesh and juices have lost all red and virulent Newcastle disease. Exotic pink color. Newcastle disease is an acute, rapidly Port of arrival. Any place in the spreading, and usually fatal viral dis- United States at which a product or ar- ease of birds and poultry. ticle arrives, unless the product or ar- Farm equipment. Equipment used in ticle remains on the means of convey- the production of livestock or crops, ance on which it arrived within the ter- including, but not limited to, mowers, harvesters, loaders, slaughter machin- ritorial limits of the United States. ery, agricultural tractors, farm en- Positive for a transmissible spongiform gines, farm trailers, farm carts, and encephalopathy. A sheep or goat for farm wagons, but excluding auto- which a diagnosis of a transmissible mobiles and trucks. spongiform encephalopathy has been Flock of origin. The flock in which the made. eggs were produced. Poultry. Chickens, turkeys, swans, Food Safety and Inspection Service. partridges, guinea fowl, pea fowl; non- The Food Safety and Inspection Serv- migratory ducks, geese, pigeons, and ice (FSIS) of the United States Depart- doves; commercial, domestic, or pen- ment of Agriculture. raised grouse, pheasants, and quail. FSIS inspector. An individual author- Premises of origin. The premises where ized by the Administrator, Food Safety the flock of origin is kept.

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Region. Any defined geographic land encephalopathy, unless the animal is area identifiable by geological, polit- designated as positive for a trans- ical, or surveyed boundaries. A region missible spongiform encephalopathy; may consist of any of the following: or (1) A national entity (country); (2) A sheep or goat that exhibits any (2) Part of a national entity (zone, of the following signs and that has county, department, municipality, par- been determined to be suspicious for a ish, Province, State, etc.) transmissible spongiform (3) Parts of several national entities encephalopathy by a veterinarian: combined into an area; or Weight loss despite retention of appe- (4) A group of national entities (coun- tite; behavior abnormalities; pruritus tries) combined into a single area. (itching); wool pulling; biting at legs or Region of origin. For meat and meat products, the region in which the ani- side; lip smacking; motor abnormali- mal from which the meat or meat prod- ties such as incoordination, high step- ucts were derived was born, raised and ping gait of forelimbs, bunny hop slaughtered; and for eggs, the region in movement of rear legs, or swaying of which the eggs were laid. back end; increased sensitivity to noise Restricted zone for classical swine fever. and sudden movement; tremor, ‘‘star An area, delineated by the relevant gazing,’’ head pressing, recumbency, or competent veterinary authorities of other signs of neurological disease or the region in which the area is located, chronic wasting. that surrounds and includes the loca- Temperature indicator device (TID). A tion of an outbreak of classical swine precalibrated temperature-measuring fever in domestic swine or detection of instrument containing a chemical com- the disease in wild boar, and from pound activated at a specific tempera- which the movement of domestic swine ture (the melting point of the chemical is prohibited. compound) identical to the processing Ruminants. All animals that chew the temperature that must be reached by cud, such as cattle, buffaloes, sheep, the meat being cooked. The Adminis- goats, deer, antelopes, camels, llamas trator will approve a TID for use after and giraffes. determining that the chemical com- Sentinel bird. A chicken that has been pound in the device is activated at the raised in an environment free of patho- specific temperature required. gens that cause communicable diseases of poultry and that has not been in- Thoroughly cooked. Heated suffi- fected with, exposed to, or immunized ciently to inactivate any pathogen with any strain of virus that causes that may be present, as indicated by Newcastle disease. the required TID or pink juice test. Specified risk materials (SRMs). Those United States. All of the States. bovine parts considered to be at par- Veterinarian in Charge. The veteri- ticular risk of containing the bovine nary official of the Animal and Plant spongiform encephalopathy (BSE) Health Inspection Service, United agent in infected animals, as listed in States Department of Agriculture, who the FSIS regulations at 9 CFR 310.22(a). is assigned by the Administrator to su- State. Any of the several States of the pervise and perform the official animal United States, the Commonwealth of health work of the Animal and Plant the Northern Mariana Islands, the Health Inspection Service in the State Commonwealth of Puerto Rico, the or area concerned. District of Columbia, Guam, the Virgin Wild swine. Any swine which are al- Islands of the United States, or any lowed to roam outside an enclosure. other territory or possession of the United States. [52 FR 33801, Sept. 8, 1987] Suspect for a transmissible spongiform EDITORIAL NOTE: For FEDERAL REGISTER ci- encephalopathy. (1) A sheep or goat that tations affecting § 94.0, see the List of CFR has tested positive for a transmissible Sections Affected, which appears in the spongiform encephalopathy or for the Finding Aids section of the printed volume proteinase resistant protein associated and at www.fdsys.gov. with a transmissible spongiform

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§ 94.1 Regions where rinderpest or section, or that enters a port in or oth- foot-and-mouth disease exists; im- erwise transits a region in which rin- portations prohibited. derpest or foot-and-mouth disease ex- (a) APHIS considers rinderpest or ists, is prohibited: foot-and-mouth disease to exist in all (1) Except as provided in part 93 of regions of the world except those de- this chapter for wild ruminants and clared free of one or both of these dis- wild swine; eases by APHIS. (2) Except as provided in paragraph (1) A list of regions that APHIS has (d) of this section for fresh (chilled or declared free of rinderpest and a list of frozen) meat of ruminants or swine regions APHIS has declared free of foot that is otherwise eligible for importa- and mouth disease are maintained on tion under this part but that enters a the APHIS Web site at http:// port or otherwise transits a region www.aphis.usda.gov/importlexport/ani- where rinderpest or foot-and-mouth mals/animalldiseaselstatus.shtml. Cop- disease exists; and ies of the list will also be available via (3) Except as provided in § 94.4 of this postal mail, fax, or email upon request part for cooked or cured meat from re- to the Sanitary Trade Issues Team, Na- gions where rinderpest or foot-and- tional Center for Import and Export, mouth disease exists. Veterinary Services, Animal and Plant (4) Except as provided in § 94.22 for Health Inspection Service, 4700 River fresh (chilled or frozen) beef from Uru- Road Unit 38, Riverdale, Maryland guay. 20737. (c) The importation of any used farm (2) APHIS will add a region to the equipment that originates in any re- list of those it has declared free of rin- gion where rinderpest or foot-and- derpest or foot-and-mouth disease, or mouth disease exists, as designated in both, after it conducts an evaluation of paragraph (a) of this section, is prohib- the region in accordance with § 92.2 of ited, unless the equipment is accom- this subchapter and finds that the dis- panied by an original certificate signed ease, or diseases, are not present. In by an authorized official of the na- the case of a region formerly on this tional animal health service of the ex- list that is removed due to an out- porting region that states that the break, the region may be returned to equipment, after its last use and prior the list in accordance with the proce- to export, was steam-cleaned free of all dures for reestablishment of a region’s exposed dirt and other particulate mat- disease-free status in § 92.4 of this sub- ter. Such farm equipment is subject to chapter. APHIS will remove a region APHIS inspection at the port of ar- from the list of those it has declared rival. If it is found during such inspec- free of rinderpest or foot-and-mouth tion to contain any exposed dirt or disease upon determining that the dis- other particulate matter, it will be de- ease exists in the region based on re- nied entry into the United States, un- ports APHIS receives of outbreaks of less, in the judgment of the APHIS in- the disease from veterinary officials of spector, the amount of exposed soil is the exporting country, from the World minimal enough to allow cleaning at Organization for Animal Health (OIE), the port of arrival, and there are ade- or from other sources the Adminis- quate facilities and personnel at the trator determines to be reliable. port to conduct such cleaning without (b) The importation of any ruminant risk of disease contamination. or swine or any fresh (chilled or frozen) (d) Except as otherwise provided in meat of any ruminant or swine 1 that this part, fresh (chilled or frozen) meat originates in any region where rinder- of ruminants or swine raised and pest or foot-and-mouth disease exists, slaughtered in a region free of foot- as designated in paragraph (a) of this and-mouth disease and rinderpest, as designated in paragraph (a)(2) of this section, and fresh (chilled or frozen) 1 Importation of animals and meat includes bringing the animals or meat within the ter- beef exported from Uruguay in accord- ritorial limits of the United States on a ance with § 94.22, which during ship- means of conveyance for use as sea stores or ment to the United States enters a for other purposes. port or otherwise transits a region

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where rinderpest or foot-and-mouth by the officer-in-charge, or certifi- disease exists may be imported pro- cation from a foreign government that vided that all of the following condi- the original seal was removed and the tions are met: new seal applied by officials of that (1) The meat is accompanied by the government) that demonstrates to the foreign meat inspection certificate re- satisfaction of the Administrator that quired by § 327.4 of this title and, upon the meat was not contaminated or ex- arrival of the meat in the United posed to contamination during move- States, the foreign meat inspection ment from the region of origin to the certificate is presented to an author- United States; and ized inspector at the port of arrival; (6) The meat is found by an author- (2) The meat is placed in the trans- ized inspector to be as represented on porting carrier in a hold, compartment, the foreign meat inspection certificate. or, if the meat is containerized, in a container that which was sealed in the (Approved by the Office of Management and region of origin by an official of such Budget under control numbers 0579–0015 and region with serially numbered seals ap- 0579–0195) proved by APHIS, so as to prevent con- [30 FR 12118, Sept. 23, 1965] tact of the meat with any other cargo, handling of the meat after the hold, EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 94.1, see the List of CFR compartment, or container is sealed, Sections Affected, which appears in the and the loading of any cargo into and Finding Aids section of the printed volume the removal of any cargo from the and at www.fdsys.gov. sealed hold, compartment, or container en route to the United States; § 94.2 Fresh (chilled or frozen) prod- (3) If any foreign official breaks a ucts (other than meat), and milk seal applied in the region of origin in and milk products of ruminants and order to inspect the meat, he or she swine. then reseals the hold, compartment, or (a) The importation of fresh (chilled container with a new serially num- or frozen) products (other than meat bered seal; and, if any member of a and milk and milk products) derived ship’s crew breaks a seal, the serial from ruminants or swine, originating number of the seal, the location of the in, shipped from, or transiting any re- seal, and the reason for breaking the gion designated in § 94.1(a) as a region seal are recorded in the ship’s log. affected with rinderpest or foot-and- (4) The serial numbers of the seals mouth disease is prohibited, except as used to seal the hold, compartment, or provided in § 94.3 and parts 95 and 96 of container are recorded on the foreign this chapter. meat inspection certificate which ac- (b) The importation of milk and milk companies the meat; products of ruminants and swine origi- (5) Upon arrival of the carrier in the nating in, shipped from, or transiting United States port of arrival, the seals any region designated in § 94.1(a) as a are found by an APHIS representative region affected with rinderpest or foot- to be intact, and the representative and-mouth disease is prohibited, except finds that there is no evidence indi- as provided in § 94.16. cating that any seal has been tampered with; Provided that, if the representa- [40 FR 44123, Sept. 25, 1975, as amended at 62 tive finds that any seal has been bro- FR 56022, Oct. 28, 1997; 77 FR 1392, Jan. 10, ken or has a different number than is 2012] recorded on the foreign meat inspection certificate, then the meat may re- § 94.3 Organs, glands, extracts, or se- main eligible for entry into the United cretions of ruminants or swine. States only if APHIS personnel are The importation of fresh (chilled or available to inspect the hold, compart- frozen) organs, glands, extracts, or se- ment, or container, the packages of cretions derived from ruminants or meat, and all accompanying docu- swine, originating in any region where mentation; and the importer furnishes rinderpest or foot-and-mouth disease additional documentation (either cop- exists, as designated in § 94.1, except for ies of pages from the ship’s log signed pharmaceutical or biological purposes

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under conditions prescribed by the Ad- graphs (a)(1), (a)(2) and (a)(3)(i) of this ministrator in each instance, is prohib- section. Upon arrival of the cured meat ited. in the United States, the certificate must be presented to an authorized in- [28 FR 5980, June 13, 1963, as amended at 53 FR 48520, Dec. 1, 1988; 62 FR 56022, Oct. 28, spector at the port of arrival. 1997; 63 FR 67574, Dec. 8, 1998] (b) The importation of cooked meats from ruminants or swine originating in § 94.4 Cured or cooked meat from re- any region where rinderpest or foot- gions where rinderpest or foot-and- and-mouth disease exists, as designated mouth disease exists. in § 94.1, is prohibited, except as pro- (a) The importation of cured meats vided in this section. derived from ruminants or swine, origi- (1) The cooked meat must be boneless nating in any region where rinderpest and must be thoroughly cooked. or foot-and-mouth disease exists, as (2) The cooked meat must have been designated in § 94.1, is prohibited unless prepared in an establishment that is el- the following conditions have been ful- igible to have its products imported filled: into the United States under the Fed- (1) All bones shall have been com- eral Meat Inspection Act (21 U.S.C. 601 pletely removed in the region of origin. et seq.) and the regulations in 9 CFR (2) The meat shall have been held in 327.2; must meet all other applicable an unfrozen, fresh condition for at requirements of the Federal Meat In- least 3 days immediately following the spection Act and regulations there- slaughter of the animals from which it under (9 CFR Chapter III); and must was derived. have been approved by the Adminis- (3)(i) The meat shall have been thor- trator in accordance with paragraph (c) oughly cured and fully dried in such of this section. manner that it may be stored and han- (3) Canned product (canned meat), as dled without refrigeration, as in the defined in § 318.300(d) of this chapter, is case of salami and other summer sau- exempt from the requirements in this sages, tasajo, xarque, or jerked beef, section. bouillon cubes, dried beef, and West- (4) Ground meat cooked in an oven. phalia, Italian and similar type hams. Ground meat must be shaped into pat- The term ‘‘fully dried’’ as used in this ties no larger than 5 inches in diameter paragraph means dried to the extent and 1-inch thick. Each patty must that the water-protein ratio in the wet- weigh no more than 115 grams, with fat test portion of the product does not ex- content no greater than 30 percent. ceed 2.25 to 1. These patties must be broiled at 210 °C (ii) Laboratory analysis of samples to for at least 133 seconds, then cooked in determine the water-protein ratios will moist heat (steam heat) in a contin- not be made in the case of all ship- uous, belt-fed oven for not less than 20 ments of cured and dried meats. How- minutes, to yield an internal exit tem- ever, in any case in which the inspector perature of at least 99.7 °C, as measured is uncertain whether the meat com- by temperature indicator devices plies with the requirements of para- (TID’s) placed in temperature monitor graph (a)(3)(i) of this section, he will patties positioned, before the belt send a sample of the meat representa- starts moving through the oven, on tive of the wettest portion to the Meat each of the predetermined cold spots Inspection Division for analysis of the along the oven belt. TID’s must be used water-protein ratio. Pending such anal- at the beginning of each processing ysis the meat shall not be released or run. removed from the port of arrival. (5) Meat cooked in tubes. Ground meat (4) The cured meat shall be accom- (which must not include cardiac mus- panied by a certificate issued by an of- cle), cubes of meat, slices of meat, or ficial of the national government of anatomical cuts of meat (cuts taken the region of origin who is authorized from the skeletal muscle tissue) weigh- to issue the foreign meat inspection ing no more than 5 kg (11.05 lbs) must certificate required by § 327.4 of this be loaded into a flexible or semiflexible title, stating that such meat has been cooking tube constructed of plastic or prepared in accordance with para- other material approved by the U.S.

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Food and Drug Administration. The issue the meat inspection certificate meat must then be cooked in either required by § 327.4 of this title. If a TID boiling water or in a steam-fed oven, in is not used, a cylindrical or square either a batch cooker or a continuous piece of at least 3.8 cm (1.5 in) in each cooker, to reach a minimum internal dimension must be cut from the cold temperature of 79.4 °C (175 °F) at the spot of each tube. The cylindrical or cold spot after cooking for at least 1.75 square piece will be the indicator piece hours. Thoroughness of cooking must for the pink juice test. The indicator be determined by a TID registering the piece or piece containing the TID must target temperature at the cold spot, or be sealed in plastic or other material by the pink juice test as follows: approved by the U.S. Food and Drug (i) Cubes of meat and ground meat. For Administration, and be accompanied cubes of meat, at least 50 percent of by a certificate issued by the official meat pieces per tube must be 3.8 cm who selected the tube. The certificate (1.5 in) or larger in each dimension must provide the date the tube was after cooking or, if more than 50 per- cooked and the cooker and batch num- cent of the cubes of meat pieces per ber, and the date the tube was selected tube are smaller than 3.8 cm (1.5 in) in any dimension after cooking, or if the for sampling. Each batch per cooker meat is ground meat, an indicator must have at least one but no more piece consisting of a single piece of than two indicator pieces or pieces con- meat of sufficient size for a pink juice taining TID’s. All indicator pieces and test to be performed (3.8 cm (1.5 in) or pieces containing TID’s must be indi- larger in each dimension after cooking) vidually sealed, properly labeled, and must have been placed at the cold spot enclosed together in one sealed box of the tube. that accompanies the shipment. Any (ii) Slices of meat. At least 50 percent indicator pieces or pieces containing of the slices of meat must be 3.8 cm (1.5 TID’s that are not used to accompany a in) or larger in each dimension after shipment to the United States must be cooking or, if more than 50 percent of destroyed following loading of the meat pieces are smaller than 3.8 cm (1.5 batch into a container; and in) in any dimension after cooking, an (ii) After removing the indicator indicator piece of sufficient size for a piece or piece containing a TID, all re- pink juice test to be performed (3.8 cm maining meat from the same batch (1.5 in) or larger in each dimension may be cut into smaller cubes and after cooking) must be placed at the sealed in plastic or other material ap- cold spot of the tube. proved by the U.S. Food and Drug Ad- (iii) Anatomical cuts of meat. An indi- ministration. After being processed cator piece removed from an anatom- into smaller cubes once, the meat may ical cut of meat after cooking must be not be further processed before ship- removed from the center of the cut, ment to the United States. The cubes farthest from all exterior points and be of meat and the indicator piece or 3.8 cm (1.5 in) or larger in each dimen- piece containing a TID must be accom- sion for performance of the pink juice panied to the United States by a cer- test. tificate as provided in paragraph (b)(8) (6) Further processing of meat cooked in of this section. tubes. Cubes of meat, slices of meat, or anatomical cuts of meat (cuts taken (7) Any TID used in accordance with from the skeletal muscle tissue) paragraph (b)(4) or (b)(5) of this section cooked in tubes in accordance with must remain in the meat, as originally paragraph (b)(5) of this section may be inserted, and must accompany the processed further after cooking if the cooked meat whose temperature it has following provisions are met: gauged when that meat is shipped to (i) For meat that is cooked and is in- the United States. tended for further processing, up to (8) Pork rind pellets (pork skins). Pork two tubes from each batch per cooker rind pellets (pork skins) must be must be randomly selected by the offi- cooked in one of the following ways: cial of the National Government of the (i) One-step process. The pork skins region of origin who is authorized to must be cooked in oil for at least 80

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minutes when oil temperature is con- (i) Request for approval of any de- sistently maintained at a minimum of frost facility must be made to the Ad- 114 °C. ministrator. The Administrator will (ii) Two-step process. The pork skins approve a defrost facility only under must be dry-cooked at 260 °C for ap- the following conditions: proximately 210 minutes after which (A) The defrost facility has equip- they must be cooked in hot oil (deep- ment and procedures that permit FSIS fried) at 104 °C for an additional 150 inspectors to determine whether meat minutes. is thoroughly cooked; (9) Certificate. (i) The cooked meat (B) The defrost facility is located at must be accompanied by a certificate a port of arrival; and issued by an official of the National (C) The defrost facility is approved Government of the region of origin who by the Food Safety and Inspection is authorized to issue the foreign meat inspection certificate required under Service, United States Department of 3 § 327.4 of this title, stating: ‘‘This Agriculture. cooked meat produced for export to the (ii) The Administrator may deny ap- United States meets the requirements proval of any defrost facility if the Ad- of title 9, Code of Federal Regulations, ministrator determines that the de- § 94.4(b).’’ Upon arrival of the cooked frost facility does not meet the condi- meat in the United States, the certifi- tions for approval. If approval is de- cate must be presented to an author- nied, the operator of the defrost facil- ized inspector at the port of arrival. ity will be informed of the reasons for (ii) For cooked meat that is further denial and be given an opportunity to processed in accordance with para- respond. The operator will be afforded graph (b)(6) of this section, the certifi- an opportunity for a hearing with re- cate must include the following state- spect to any disputed issues of fact. ment, in addition to the certification The hearing will be conducted in ac- required under paragraph (b)(9)(i) of cordance with rules of practice that this section: ‘‘No more than two tubes will be adopted for the proceeding. were randomly selected per batch per (iii) The Administrator may with- cooker for cutting an indicator piece or draw approval of any defrost facility as obtaining a piece containing a TID. follows: (A) When the operator of the The indicator piece or piece containing defrost facility notifies the Adminis- a TID represents a shipment of (de- trator in writing that the defrost facil- scribe form of processed product—e.g., diced cubes of a particular size). A ity no longer performs the required piece containing a TID or a piece 3.8 services; or (B) when the Administrator cm (1.5 in) or larger in each dimension determines that the defrost facility was cut from the cold spot of the tube, does not meet the conditions for ap- and was sealed and marked with the proval. Before the Administrator with- following cooking date, cooker, and draws approval from any defrost facil- batch: lllll and the following date ity, the operator of the defrost facility of selection of the tubelllll. The will be informed of the reasons for the total number of indicator pieces or proposed withdrawal and given an op- pieces containing TID’s enclosed in a portunity to respond. The operator will sealed box islllll.’’ be afforded a hearing with respect to (10) The meat is inspected by an FSIS any disputed issues of fact. The hearing inspector at a port of arrival in a de- will be conducted in accordance with frost facility approved by the Adminis- rules of practice that will be adopted trator 2 and the meat is found to be thoroughly cooked. 3 Conditions for the approval of any defrost facility by the Food Safety and Inspection 2 The names and addresses of approved de- Service, United States Department of Agri- frost facilities and conditions for approval culture, may be obtained from the Import In- may be obtained from the Administrator, spection Division, International Programs, Animal and Plant Health Inspection Service, Food Safety and Inspection Service, United United States Department of Agriculture, States Department of Agriculture, Wash- Washington, DC 20250. ington, DC 20250.

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for the proceeding. If approval of a de- representative, including travel, sal- frost facility is withdrawn, the Admin- ary, subsistence, administrative over- istrator will remove its name from the head, and other incidental expenses (in- list of approved defrost facilities. cluding an excess baggage provision up (c) Meat processing establishment; to 150 pounds). As funds from that standards. (1) Before the Administrator amount are obligated, a bill for costs will approve a meat processing estab- incurred based on official accounting lishment for export shipment of cooked records will be issued, to restore the meat to the United States, the Admin- deposit to the original level, revised as istrator must determine: necessary to allow for inflation or (i) That the meat processing estab- other changes in estimated costs. To be lishment has furnished APHIS with a current, bills must be paid within 14 description of the process used to inac- days of receipt. tivate rinderpest or FMD virus that (2) Establishment. An APHIS rep- may be present in meat intended for resentative will conduct an on-site export to the United States, and with evaluation, and subsequent inspec- blueprints of the facilities where this tions, as provided in § 94.4(c)(1), to de- meat is cooked and packaged; termine whether the following condi- (ii) That an APHIS representative tions are met: has inspected the establishment and (i) The facilities used for processing found that it meets the standards set cooked meat in the meat processing es- forth in paragraph (c)(2) of this section; tablishment are separate from the fa- (iii) That the operator of the estab- cilities used for processing raw meat lishment has signed a cooperative serv- (precooking, boning, preparation, and ice agreement with APHIS, stating: (A) curing), with only the through-the-wall That all cooked meat processed for im- cooking system through which the portation into the United States will meat product is delivered at the end of be processed in accordance with the re- the cooking cycle connecting them; quirements of this part; (B) that a full- and there is at all times a positive air time, salaried meat inspection official flow from the cooked to the raw prod- of the National Government of the ex- uct side; porting region will supervise the proc- (ii) The cooking equipment has the essing (including certification of the capacity to cook all meat pieces in ac- cold spot) and examination of the prod- cordance with § 94.4(b)(4) or (b)(5); uct, and certify that it has been proc- (iii) Workers who process cooked essed in accordance with this section; meat are at all times kept separate and (C) that APHIS personnel or other from workers who process raw meat, persons authorized by the Adminis- and have, for their exclusive use: A sep- trator may enter the establishment, arate entrance, dining area, toilets, unannounced, to inspect the establish- lavatories with cold and hot water, ment and its records; and soap, disinfectants, paper towels, (iv) That the operator of the estab- clothes hampers and waste baskets for lishment has entered into a trust fund disposal, and changing rooms stocked agreement with APHIS and is current with the clean clothing and rubber in paying all costs for an APHIS rep- boots into which all persons must resentative to inspect the establish- change upon entering the establishment for initial evaluation, and periment. Workers and all other persons odically thereafter, including travel, entering the establishment must wash salary, subsistence, administrative their hands and change into the clean overhead, and other incidental ex- clothing and boots provided in the penses (including an excess baggage changing rooms before entering the provision up to 150 pounds). In accord- cooking facilities, and must leave this ance with the terms of the trust fund clothing for laundering and disagreement, before the APHIS rep- infecting before exiting from the estab- resentative’s site inspection, the oper- lishment, regardless of the amount of ator of the processing establishment time spent inside or away from the es- must deposit with the Administrator tablishment; an amount equal to the approximate (iv) Original records identifying the cost of one inspection by an APHIS slaughtering facility from which the

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meat was obtained and the date the plant pests and livestock or poultry meat entered the meat processing es- diseases, and that it is certified by an tablishment, and original certification appropriate Government official as (including temperature recording currently complying with the applica- charts and graphs), must be kept for all ble laws for environmental protection. cooked meat by the full-time salaried Approved sewage system. A sewage sys- meat inspection official of the National tem approved by the Administrator, Government of the exporting region as- Animal and Plant Health Inspection signed to the establishment, and must Service, upon his determination that be retained for 2 years. the system is designed and operated in (Approved by the Office of Management and such a way as to preclude the discharge Budget under control number 0579–0015) of sewage effluents onto land surfaces or into lagoons or other stationary [28 FR 5980, June 13, 1963] waters, and otherwise is adequate to EDITORIAL NOTE: For FEDERAL REGISTER ci- prevent the dissemination of plant tations affecting § 94.2, see the List of CFR pests and livestock or poultry diseases, Sections Affected, which appears in the and that is certified by an appropriate Finding Aids section of the printed volume and at www.fdsys.gov. Government official as currently complying with the applicable laws for en- § 94.5 Regulation of certain garbage. vironmental protection. (a) General restrictions—(1) Interstate Carrier. The principal operator of a movements of garbage from Hawaii and means of conveyance. U.S. territories and possessions to the con- Continental United States. The 49 tinental United States. Hawaii, Puerto States located on the continent of Rico, American Samoa, the Common- North America and the District of Co- wealth of the Northern Mariana Is- lumbia. lands, the Federated States of Micro- Garbage. All waste material that is nesia, Guam, the U.S. Virgin Islands, derived in whole or in part from fruits, Republic of the Marshall Islands, and vegetables, meats, or other plant or the Republic of Palau are hereby quar- animal (including poultry) material, antined, and the movement of garbage and other refuse of any character what- therefrom to any other State is hereby soever that has been associated with prohibited except as provided in this any such material. section in order to prevent the intro- Incineration. To reduce garbage to duction and spread of exotic plant ash by burning. pests and diseases. Inspector. A properly identified em- (2) Imports of garbage. In order to pro- ployee of the U.S. Department of Agri- tect against the introduction of exotic culture or other person authorized by animal and plant pests, the importa- the Department to enforce the provi- tion of garbage from all foreign coun- sions of applicable statutes, quar- tries except Canada is prohibited ex- antines, and regulations. cept as provided in paragraph (c)(2) of Interstate. From one State into or this section. through any other State. (b) Definitions—Agricultural waste. By- Person. Any individual, corporation, products generated by the rearing of company, association, firm, partner- animals and the production and har- ship, society, or joint stock company. vest of crops or trees. Animal waste, a Shelf-stable. The condition achieved large component of agricultural waste, in a product, by application of heat, includes waste (e.g., feed waste, bed- alone or in combination with other in- ding and litter, and feedlot and pad- gredients and/or other treatments, of dock runoff) from livestock, dairy, and being rendered free of microorganisms other animal-related agricultural and capable of growing in the product farming practices. under nonrefrigerated conditions (over Approved facility. A facility approved 50 °F or 10 °C). by the Administrator, Animal and Sterilization. Cooking garbage at an Plant Health Inspection Service, upon internal temperature of 212 °F for 30 his determination that it has equip- minutes. ment and uses procedures that are ade- Stores. The food, supplies, and other quate to prevent the dissemination of provisions carried for the day-to-day

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operation of a conveyance and the care fruits and vegetables; and all eggs; and and feeding of its operators. the items previously cleared from the Yard waste. Solid waste composed aircraft as prescribed by this paragraph predominantly of grass clippings, have been disposed of according to the leaves, twigs, branches, and other gar- procedures for disposing of regulated den refuse. garbage, as specified in paragraphs (c) Garbage generated onboard a con- (c)(4)(ii) and (c)(4)(iii) of this section. veyance—(1) Applicability. This section (B) After the garbage and stores re- applies to garbage generated onboard ferred to in paragraph (c)(2)(i)(A) of any means of conveyance during inter- this section were removed, the aircraft national or interstate movements as has not been in a non-Canadian foreign provided in this section and includes port. food scraps, table refuse, galley refuse, (ii) Exception 2: Other conveyances. food wrappers or packaging materials, Garbage on or removed in the United and other waste material from stores, States from a means of conveyance food preparation areas, passengers’ or other than an aircraft is exempt from crews’ quarters, dining rooms, or any requirements under paragraph (c)(4) of other areas on the means of convey- this section if the following conditions ance. This section also applies to meals are met when the garbage is on or re- and other food that were available for moved from the means of conveyance: consumption by passengers and crew (A) The means of conveyance is ac- on an aircraft but were not consumed. companied by a certificate from an in- (i) Not all garbage generated onboard spector stating the following: a means of conveyance is regulated for (1) That the means of conveyance had the purposes of this section. Garbage previously been cleared of all garbage regulated for the purposes of this sec- and of all meats and meat products, tion is defined as ‘‘regulated garbage’’ whatever the country of origin, except in paragraphs (c)(2) and (c)(3) of this meats that are shelf-stable; all fresh section. and condensed milk and cream from (ii) Garbage that is commingled with countries designated in § 94.1 as those regulated garbage is also regulated gar- in which foot-and-mouth disease exists; bage. all fresh fruits and vegetables; and all (2) Garbage regulated because of move- eggs; and the items previously cleared ments outside the United States or Can- from the means of conveyance as pre- ada. For purposes of this section, gar- scribed by this paragraph have been bage on or removed from a means of disposed of according to the procedures conveyance is regulated garbage, if, for disposing of regulated garbage, as when the garbage is on or removed specified in paragraphs (c)(4)(ii) and from the means of conveyance, the (c)(4)(iii) of this section. means of conveyance has been in any (2) That the means of conveyance had port outside the United States and then been cleaned and disinfected in Canada within the previous 2-year pe- the presence of the inspector; and riod. There are, however, two excep- (B) Since being cleaned and dis- tions to this provision. These excep- infected, the means of conveyance has tions are as follows: not been in a non-Canadian foreign (i) Exception 1: Aircraft. Garbage on or port. removed from an aircraft is exempt (3) Garbage regulated because of certain from requirements under paragraph movements to or from Hawaii, territories, (c)(4) of this section if the following or possessions. For purposes of this sec- conditions are met when the garbage is tion, garbage on or removed from a on or removed from the aircraft: means of conveyance is regulated gar- (A) The aircraft had previously been bage, if at the time the garbage is on or cleared of all garbage and of all meats removed from the means of convey- and meat products, whatever the coun- ance, the means of conveyance has try of origin, except meats that are moved during the previous 1-year pe- shelf-stable; all fresh and condensed riod, either directly or indirectly, to milk and cream from countries des- the continental United States from any ignated in § 94.1 as those in which foot- territory or possession or from Hawaii, and-mouth disease exists; all fresh to any territory or possession from any

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other territory or possession or from Hawaii; or to Hawaii from any terri- Hawaii, or to Hawaii from any territory or possession. tory or possession. There are, however, (4) Restrictions on regulated garbage. two exceptions to this provision. These (i) Regulated garbage may not be dis- exceptions are as follows: posed of, placed on, or removed from a (i) Exception 1: Aircraft. Garbage on or means of conveyance except in accord- removed from an aircraft is exempt ance with this section. from requirements under paragraph (ii) Regulated garbage is subject to (c)(4) of this section if the following general surveillance for compliance two conditions are met when the gar- with this section by inspectors and to bage is on or removed from the air- disposal measures authorized by the craft: Plant Protection Act and the Animal (A) The aircraft had been previously Health Protection Act to prevent the cleared of all garbage and all fresh introduction and dissemination of fruits and vegetables, and the items pests and diseases of plants and live- previously cleared from the aircraft as stock. prescribed by this paragraph have been (iii) All regulated garbage must be disposed of according to the procedures contained in tight, covered, leak-proof for disposing of regulated garbage, as specified in paragraphs (c)(4)(ii) and receptacles during storage on board a (c)(4)(iii) of this section. means of conveyance while in the terri- (B) After the garbage and stores re- torial waters, or while otherwise with- ferred to in paragraph (c)(3)(i)(A) of in the territory of the United States. this section were removed, the aircraft All such receptacles shall be contained has not moved to the continental inside the guard rail if on a watercraft. United States from any territory or Such regulated garbage shall not be possession or from Hawaii, to any ter- unloaded from such means of convey- ritory or possession from any other ance in the United States unless such territory or possession or from Hawaii, regulated garbage is removed in tight, or to Hawaii from any territory or pos- covered, leak-proof receptacles under session. the direction of an inspector to an ap- (ii) Exception 2: Other conveyances. proved facility for incineration, steri- Garbage on or removed from a means lization, or grinding into an approved of conveyance other than an aircraft is sewage system, under direct super- exempt from requirements under para- vision by such an inspector, or such graph (c)(4) of this section if the fol- regulated garbage is removed for other lowing two conditions are met when handling in such manner and under the garbage is on or removed from the such supervision as may, upon request means of conveyance: in specific cases, be approved by the (A) The means of conveyance is ac- Administrator as adequate to prevent companied by a certificate from an in- the introduction and dissemination of spector stating that the means of con- plant pests and animal diseases and veyance had been cleared of all garbage sufficient to ensure compliance with and all fresh fruits and vegetables, and applicable laws for environmental pro- the items previously cleared from the tection. Provided that, a cruise ship means of conveyance as prescribed by may dispose of regulated garbage in this paragraph have been disposed of landfills at Alaskan ports only, if and according to the procedures for dis- only if the cruise ship does not have posing of regulated garbage, as speci- prohibited or restricted meat or animal fied in paragraphs (c)(4)(ii) and products on board at the time it enters (c)(4)(iii) of this section. Alaskan waters for the cruise season, (B) After being cleared of the garbage and only if the cruise ship, except for and stores referred to in paragraph incidental travel through international (c)(3)(ii)(A) of this section, the means waters necessary to navigate safely be- of conveyance has not moved to the tween ports, remains in Canadian and continental United States from any U.S. waters off the west coast of North territory or possession or from Hawaii; America, and calls only at continental to any territory or possession from any U.S. and Canadian ports during the en- other territory or possession or from tire cruise season.

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(A) Application for approval of a fa- (d) Garbage generated in Hawaii—(1) cility or sewage system may be made Applicability. This section applies to in writing by the authorized represent- garbage generated in households, com- ative of any carrier or by the official mercial establishments, institutions, having jurisdiction over the port or and businesses prior to interstate place of arrival of the means of convey- movement from Hawaii, and includes ance to the Administrator, Animal and used paper, discarded cans and bottles, Plant Health Inspection Service, U.S. and food scraps. Such garbage includes, Department of Agriculture, Wash- and is commonly known as, municipal ington, DC 20250. The application must solid waste. be endorsed by the operator of the fa- (i) Industrial process wastes, mining cility or sewage system. wastes, sewage sludge, incinerator ash, (B) Approval will be granted if the or other wastes from Hawaii that the Administrator determines that the re- Administrator determines do not pose quirements set forth in this section are risks of introducing animal or plant met. Approval may be denied or with- pests or diseases into the continental drawn at any time, if the Adminis- United States are not regulated under trator determines that such require- this section. (ii) The interstate movement from ments are not met, after notice of the Hawaii to the continental United proposed denial or withdrawal of the States of agricultural wastes and yard approval and the reasons therefor, and waste (other than incidental amounts an opportunity to demonstrate or (less than 3 percent) that may be achieve compliance with such require- present in municipal solid waste de- ments, has been afforded to the oper- spite reasonable efforts to maintain ator of the facility or sewage system source separation) is prohibited. and to the applicant for approval. How- (iii) Garbage generated onboard any ever, approval may also be withdrawn means of conveyance during interstate without such prior procedure in any movement from Hawaii is regulated case in which the public health, inter- under paragraph (c) of this section. est, or safety requires immediate ac- (2) Restrictions on interstate movement tion, and in such case, the operator of of garbage. The interstate movement of the facility or sewage system and the garbage generated in Hawaii to the applicant for approval shall promptly continental United States is regulated thereafter be given notice of the with- as provided in this section. drawal and the reasons therefore and (i) The garbage must be processed, an opportunity to show cause why the packaged, safeguarded, and disposed of approval should be reinstated. using a methodology that the Adminis- (iv) The Plant Protection and Quar- trator has determined is adequate to antine Programs and Veterinary Serv- prevent the introduction and dissemi- ices, Animal, and Plant Health Inspec- nation of plant pests into noninfested tion Service, will cooperate with other areas of the United States. Federal, State, and local agencies re- (ii) The garbage must be moved under sponsible for enforcing other statutes a compliance agreement in accordance and regulations governing disposal of with paragraph (e) of this section. the regulated garbage to the end that APHIS will only enter into a compli- such disposal shall be adequate to pre- ance agreement when the Adminis- vent the dissemination of plant pests trator is satisfied that the Agency has and livestock or poultry diseases and first satisfied all its obligations under comply with applicable laws for envi- the National Environmental Policy Act ronmental protection. The inspectors, and all applicable Federal and State in maintaining surveillance over regu- statutes to fully assess the impacts as- lated garbage movements and disposal, sociated with the movement of garbage shall coordinate their activities with under the compliance agreement. the activities of representatives of the (iii) All such garbage moved inter- U.S. Environmental Protection Agency state from Hawaii to any of the conti- and other Federal, State, and local nental United States must be moved in agencies also having jurisdiction over compliance with all applicable laws for such regulated garbage. environmental protection.

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(e) Compliance agreement and cancella- (4) Any compliance agreement may tion—(1) Any person engaged in the be canceled, either orally or in writing, business of handling or disposing of by an inspector whenever the inspector garbage in accordance with this section finds that the person who has entered must first enter into a compliance into the compliance agreement has agreement with the Animal and Plant failed to comply with this section. If Health Inspection Service (APHIS). the cancellation is oral, the cancella- Compliance agreement forms (PPQ tion and the reasons for the cancella- Form 519) are available without charge tion will be confirmed in writing as from local USDA/APHIS/Plant Protec- promptly as circumstances allow. Any tion and Quarantine offices, which are person whose compliance agreement listed in telephone directories. has been canceled may appeal the deci- (2) A person who enters into a com- sion, in writing, within 10 days after pliance agreement, and employees or receiving written notification of the agents of that person, must comply cancellation. The appeal must state all with the following conditions and any of the facts and reasons upon which the supplemental conditions which are list- person relies to show that the complied in the compliance agreement, as ance agreement was wrongfully can- deemed by the Administrator to be celed. As promptly as circumstances necessary to prevent the introduction allow, the Administrator will grant or and dissemination into or within the deny the appeal, in writing, stating the United States of plant pests and live- reasons for the decision. A hearing will stock or poultry diseases: be held to resolve any conflict as to (i) Comply with all applicable provi- any material fact. Rules of practice sions of this section; concerning a hearing will be adopted (ii) Allow inspectors access to all by the Administrator. This administra- records maintained by the person re- tive remedy must be exhausted before a garding handling or disposal of gar- person can file suit in court chal- bage, and to all areas where handling lenging the cancellation of a compli- or disposal of garbage occurs; ance agreement. (iii)(A) If the garbage is regulated (5) Where a compliance agreement is under paragraph (c) of this section, re- denied or canceled, the person who en- move garbage from a means of convey- tered into or applied for the compliance only in tight, covered, leak-proof ance agreement may be prohibited, at receptacles; the discretion of the Administrator, (B) If the garbage is regulated under from handling or disposing of regulated paragraph (d) of this section, transport garbage. garbage interstate in sealed, leak-proof (Approved by the Office of Management and packaging approved by the Adminis- Budget under control numbers 0579–0015, trator; 0579–0054, and 0579–0292) (iv) Move the garbage only to a facil- [71 FR 49317, Aug. 23, 2006] ity approved by the Administrator; and (v) At the approved facility, dispose § 94.6 Carcasses, meat, parts or prod- of the garbage in a manner approved by ucts of carcasses, and eggs (other the Administrator and described in the than hatching eggs) of poultry, compliance agreement. game birds, or other birds; importa- (3) Approval for a compliance agree- tions from regions where exotic ment may be denied at any time if the Newcastle disease or highly patho- Administrator determines that the ap- genic avian influenza is considered to exist. plicant has not met or is unable to meet the requirements set forth in this (a) Disease status of regions for exotic section. Prior to denying any applica- Newcastle disease (END) and highly path- tion for a compliance agreement, ogenic avian influenza (HPAI)—(1) Re- APHIS will provide notice to the appli- gions in which END is not considered to cant thereof, and will provide the ap- exist. (i) END is considered to exist in plicant with an opportunity to dem- all the regions of the world except the onstrate or achieve compliance with following: Argentina, Australia, Can- requirements. ada, Chile, Costa Rica, Denmark, Fiji,

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Finland, France, Great Britain (Eng- it conducts an evaluation of the region land, Scotland, Wales, and the Isle of and finds that HPAI is not likely to be Man), Greece, Iceland, Luxembourg, present in its commercial bird or poul- Mexico (States of Campeche, Quintana try populations. Roo, and Yucatan), New Zealand, Re- (b) Carcasses, and parts or products of public of Ireland, Spain, Sweden, and carcasses, including meat, from regions Switzerland. APHIS has evaluated where END or HPAI is considered to exist. these regions for the presence of END. This paragraph applies to carcasses, Regions not listed may have END, or and parts or products of carcasses,4 in- may not have been evaluated for END cluding meat, of poultry, game birds, status. or other birds that were raised or (ii) APHIS will remove a region from slaughtered in any region where END the list in paragraph (a)(1)(i) of this or any subtype of HPAI is considered section upon determining that END ex- to exist (see paragraph (a) of this sec- ists there based on reports APHIS re- tion); are imported from any such receives of outbreaks of the disease in gion; or are moved into or through any commercial birds or poultry from vet- such region at any time before impor- erinary officials of the exporting coun- tation or during shipment to the try, from the World Organization for United States. Animal Health (OIE), or from other (1) Carcasses of game birds, if evis- sources the Administrator determines cerated with heads and feet removed, to be reliable. APHIS will add a region may be imported from regions where to this list after it conducts an evalua- END is considered to exist. Carcasses tion of the region and finds that END is of game birds may not be imported not likely to be present in its commer- from regions where any subtype of cial bird or poultry populations. In the HPAI is considered to exist. Viscera, case of a region formerly on this list heads, and feet removed from game that is removed due to an outbreak, birds in any of these regions are ineli- the region may be returned to the list gible for entry into the United States. in accordance with the procedures for (2) Carcasses, or parts or products of reestablishment of a region’s disease- carcasses, of poultry, game birds, and free status in § 92.4 of this subchapter. other birds may be imported for con- (2) Regions in which HPAI is considered signment to any museum, educational to exist. (i) A list of such regions is institution or other establishment maintained on the APHIS National which has provided the Administrator Center for Import and Export Web site with evidence that it has the equip- at http://www.aphis.usda.gov/ ment, facilities, and capabilities to importlexport/animals/ store, handle, process, or disinfect such animalldiseaselstatus.shtml. Copies of articles so as to prevent the introduc- the list will also be available via postal tion or dissemination of END or HPAI mail, fax, or e-mail upon request to into the United States, and which is Sanitary Trade Issue Team, National approved by the Administrator.5 Center for Import and Export, Veteri- (3) Carcasses, or parts or products of nary Services, Animal and Plant carcasses, including meat, of poultry, Health Inspection Service, 4700 River game birds, or other birds, may be im- Road, Unit 38, Riverdale, Maryland ported if packed in hermetically sealed 20737. containers and if cooked by a commer- (ii) APHIS will consider a region to cial method after such packing to have HPAI and add it to this list ref- produce articles that are shelf stable erenced in paragraph (a)(2)(i) of this without refrigeration. section upon determining that HPAI exists in commercial birds or poultry in the region based on reports APHIS 4 Animal byproducts are regulated under receives of outbreaks of the disease part 95 of this subchapter. 5 from veterinary officials of the export- The names and addresses of approved establishments may be obtained from, and re- ing country, from the OIE, or from quests for approval may be made to the Na- other sources the Administrator deter- tional Center for Import-Export, Veterinary mines to be reliable. APHIS will re- Services, APHIS, 4700 River Road, Unit 38, move a region from this list only after Riverdale, Maryland 20737–1231.

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(4) Carcasses and parts or products of tional government has determined that carcasses, including meat, of poultry, the seals are intact and free of any evi- game birds, or other birds, may be im- dence of tampering. The official must ported if they are accompanied by a attest to this fact by signing the cer- certificate that is signed by a full- tificate accompanying the shipment. time, salaried veterinarian of the gov- (B) [Reserved] ernment agency responsible for animal (ii) Handling of poultry, game bird, or health in the region and that specifies other bird carcasses or parts or products. that the articles were cooked through- Establishments in regions where END out to reach a minimum internal tem- or HPAI is considered to exist that perature of 74 °C (165 °F). process poultry, game bird, or other (5) Carcasses, and parts or products bird carcasses or parts or products for of carcasses, including meat, of poul- export to the United States: try, game birds, or other birds, that (A) May not receive or handle any originated in a region considered to be live poultry or birds. free of END and any subtype of HPAI, (B) Must keep any records required and that are processed (cut, packaged, by this section on file at the facility or other processing) in a region where for a period of at least 2 years after ex- END or HPAI is considered to exist, port of processed products to the may be imported under the following United States, and must make those conditions: records available to USDA inspectors (i) Shipment to processing establish- during inspections. ments. All poultry, game bird, or other (C) May process carcasses or parts or bird products from such regions shall products that originate in any region, be shipped from the END and HPAI- provided that: free region where they originated to a (1) All areas, utensils, and equipment processing establishment 6 in the re- likely to contact the carcasses or parts gion where END or HPAI is considered or products to be processed, including to exist in closed containers sealed skinning, deboning, cutting, and pack- with serially numbered seals applied by ing areas, are cleaned and disinfected an official of the national government between processing carcasses or parts of that region. They must be accom- or products from regions where END or panied by a certificate that is signed HPAI is considered to exist and proc- by a full-time, salaried veterinarian of essing those from END and HPAI-free the government agency responsible for regions. animal health in the region and that (2) Carcasses or parts or products in- specifies the products’ region of origin, tended for export to the United States the processing establishment to which are not handled, cut, or otherwise proc- the carcasses or parts or products are essed at the same time as any car- consigned, and the numbers of the seals casses or parts or products not eligible applied to the shipping containers. for export to the United States. (A) The poultry, game bird, or other (3) Carcasses or parts or products in- bird carcasses or parts or products may tended for export to the United States be removed from containers at the are packed in clean new packaging that processing establishment in the region is clearly distinguishable from that where END or HPAI is considered to containing any carcasses or parts or exist only after an official of the na- products not eligible for export to the United States. 6 As a condition of entry into the United (4) Carcasses or parts or products are States, poultry species and poultry products stored in a manner that ensures that addressed by the Poultry Products Inspec- no cross-contamination occurs. tion Act (PPIA, 21 U.S.C. 451 et seq.) and reg- (iii) Cooperative service agreement. Op- ulations thereunder (9 CFR, chapter III, part erators of processing establishments 381), must also meet all of the requirements must enter into a cooperative service of the PPIA and part 381, including require- agreement with APHIS to pay all ex- ments that the poultry or poultry products be prepared only in establishments approved penses incurred by APHIS in inspecting by FSIS. Species subject to these require- the establishment. APHIS anticipates ments include chickens, turkeys, ducks, that such inspections will occur once a geese, guineas, ratites, or squabs. year. The cooperative service account

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must always contain a balance that is through any region where END is con- at least equal to the cost of one inspec- sidered to exist at any time before im- tion. APHIS will charge the coopera- portation or during shipment to the tive service account for travel, salary, United States. and subsistence of APHIS employees, (1) With a certificate. The eggs may be as well as administrative overhead and imported if they are accompanied by a other incidental expenses (including certificate signed by a salaried veteri- excess baggage charges up to 150 nary officer of the national govern- pounds). ment of the region of origin or, if ex- (iv) Shipment to the United States. ported from Mexico, accompanied ei- Poultry, game bird, or other bird car- ther by such a certificate or by a cer- casses or parts or products to be im- tificate issued by a veterinarian ac- ported into the United States must be credited by the national government of shipped from the region where they Mexico and endorsed by a full-time sal- were processed in closed containers aried veterinary officer of the national sealed with serially numbered seals ap- government of Mexico, thereby rep- plied by an official of the national gov- resenting that the veterinarian issuing ernment of that region. The shipments the certificate was authorized to do so, must be accompanied by a certificate and: signed by an official of the national (i) The eggs are imported in cases government of the region where arti- marked with the identity of the flock cles were processed that lists the num- of origin and sealed with the seal of the bers of the seals applied and states that national government of the region of all of the conditions of this section origin. have been met. A copy of this certifi- (ii) The certificate accompanying the cate must be kept on file at the proc- eggs is presented to an authorized in- essing establishment for at least 2 spector when the eggs reach the port of years. arrival in the United States. (6) Poultry, game bird, or other bird carcasses or parts or products that do (iii) The certificate identifies the not otherwise qualify for importation flock of origin and shows the region of under paragraphs (b)(1) through (5) of origin, the port of embarkation, the this section may be imported only if port of arrival, the name and address of the importer applies to, and is granted the exporter and importer, the total a permit by, the Administrator, au- number of eggs, and cases of eggs, thorizing such importation. A permit shipped with the certificate, and the will be given only when the Adminis- date the certificate was signed. trator determines that such importa- (iv) The certificate states that the tion will not constitute a risk of intro- eggs qualify for importation in accord- duction or dissemination of END or ance with this section. HPAI into the United States. Applica- (v) The certificate states that no tion for a permit may be made in ac- more than 90 days before the certifi- cordance with paragraph (d) of this sec- cate was signed, a salaried veterinary tion. officer of the national government of (c) Eggs (other than hatching eggs) the region of origin or, if exported from from regions where END is considered to Mexico, by a veterinarian accredited exist. Eggs (other than hatching eggs 7) by the national government of Mexico, from poultry, game birds, or other inspected the flock of origin and found birds may be imported only in accord- no evidence of communicable diseases ance with this section if they: Are laid of poultry. by poultry, game birds, or other birds (vi) The eggs were washed, to remove that are raised in any region where foreign material from the surface of END is considered to exist (see para- the shells, and sanitized on the prem- graph (a) of this section); are imported ises of origin with a hypochlorite solu- from any region where END is consid- tion of from 100 ppm to 200 ppm avail- ered to exist; or are moved into or able chlorine. (vii) The eggs were packed on the 7 The requirements for importing hatching premises of origin in previously unused eggs are contained in part 93 of this chapter. cases.

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(viii) Before leaving the premises of flock of origin, for the 90 days prior to origin, the cases in which the eggs were the issuance of the certificate. packed were sealed with a seal of the (2) To an approved establishment for national government of the region of breaking and pasteurization. The eggs origin by the salaried veterinarian of may be imported if they are moved the national government of the region from the port of arrival in the United of origin who signed the certificate or, States, under seal of the United States if exported from Mexico, by the veteri- Department of Agriculture, to an ap- narian accredited by the national gov- proved establishment for breaking and ernment of Mexico who signed the cer- pasteurization. Establishments will be tificate. approved when the Administrator de- (ix) In addition, if the eggs were laid termines that pasteurization and sani- in any region where END is considered tation procedures for handling the to exist (see paragraph (a) of this sec- eggs, and for disposing of egg shells, tion), the certificate must also state: cases, and packing materials, are ade- (A) No END occurred on the premises quate to prevent the introduction of of origin or on adjoining premises dur- END into the United States. ing the 90 days before the certificate (3) For scientific, educational, or re- was signed. search purposes. The eggs may be im- (B) There is no evidence that the ported if they are imported for sci- flock of origin was exposed to END dur- entific, educational, or research pur- ing the 90 days before the certificate poses and the Administrator has deter- was signed. mined that the importation can be (C) The eggs are from a flock of ori- made under conditions that will pre- gin found free of END as follows: On vent the introduction of END into the the seventh and fourteenth days of the United States. The eggs must be ac- 21-day period before the certificate is companied by a permit obtained from signed, at least 1 cull bird (a sick or APHIS prior to the importation in ac- dead bird, not a healthy bird that was cordance with paragraph (f) of this sec- killed) for each 10,000 live birds occu- tion, and they must be moved and han- pying each poultry house certified for dled as specified on the permit to pre- exporting table eggs was tested for vent the introduction of END into the END virus using embryonated egg in- United States. oculation technique. The weekly cull (4) Other. The eggs may be imported rate of birds of every exporting poultry when the Administrator determines house within the exporting farm does that the eggs have been cooked or proc- not exceed 0.1 percent. The tests essed or will be handled in a manner that will prevent the introduction of present no clinical or immunological END into the United States. The eggs evidence of END by embryonated egg must be accompanied by a permit ob- inoculation technique from tissues of tained from APHIS prior to the impor- birds that were culled and have been tation in accordance with paragraph (f) collected by a salaried veterinary offi- of this section, and they must be cer of the national government of the moved and handled as specified on the region of origin or by a veterinarian permit to prevent the introduction of accredited by the national government END into the United States. of Mexico. All examinations and (d) To apply for a permit, contact the embryonated egg inoculation tests Animal and Plant Health Inspection were conducted in a laboratory located Service, Veterinary Services, National in the region of origin, and the labora- Center for Import-Export, 4700 River tory was approved to conduct the ex- Road Unit 38, Riverdale, Maryland aminations and tests by the veterinary 20737–1231. services organization of the national government of that region. All results (Approved by the Office of Management and were negative for END. Budget under control numbers 0579–0015, (D) Egg drop syndrome is notifiable 0579–0245, 0579–0328, and 0579–0367) in the region of origin and there have [39 FR 39546, Nov. 8, 1974; 39 FR 41242, Nov. 26, been no reports of egg drop syndrome 1974] in the flocks of origin of the eggs, or EDITORIAL NOTE: For FEDERAL REGISTER ci- within a 50 kilometer radius of the tations affecting § 94.6, see the List of CFR

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Sections Affected, which appears in the into the United States by any means Finding Aids section of the printed volume but are not offered for entry into this and at www.fdsys.gov. country, and other animals, meats, and other articles prohibited importation § 94.7 Disposal of animals, meats, and other articles ineligible for importa- under other sections of this part, which tion. come into the United States by any means, whether they are offered for (a) Ruminants and swine, and fresh entry into this country or not, shall be (chilled or frozen) meats, prohibited immediately destroyed or otherwise importation under §§ 94.1, 94.8, 94.9, disposed of as the Administrator may 94.10, 94.12, 94.14, or 94.18, which come direct at any time. into the United States by ocean vessel and are offered for entry and refused [68 FR 6345, Feb. 7, 2003] admission into this country, shall be destroyed or otherwise disposed of as § 94.8 Pork and pork products from re- the Administrator may direct, unless gions where African swine fever ex- they are exported by the consignee ists or is reasonably believed to exist. within 48 hours, and meanwhile are retained under such isolation and other (a) African swine fever exists or the safeguards as the Administrator may Administrator has reason to believe require to prevent the introduction or that African swine fever exists in the dissemination of livestock diseases regions listed under paragraph (a)(2) of into the United States. this section. (b) Ruminants and swine, and fresh (1) The Administrator bases the rea- (chilled or frozen) meats, prohibited son to believe African swine fever ex- importation under §§ 94.1, 94.8, 94.9, ists in a region on the following fac- 94.10, 94.12, 94.14, or 94.18, which come tors: into the United States aboard an air- (i) When a region allows the importa- plane or railroad car and are offered for tion of host animals, pork or pork entry and refused admission into this products, or vectors of African swine country, shall be destroyed or other- fever from a region in which African wise disposed of as the Administrator swine fever exists under conditions may direct, unless they are exported by which the Administrator has deter- the consignee within 24 hours, and mined are less stringent than those meanwhile are retained under such iso- prescribed by this chapter for import- lation and other safeguards as the Ad- ing host animals, pork or pork prod- ministrator may require to prevent the ucts, or vectors of African swine fever introduction or dissemination of live- into the United States from a region in stock diseases into the United States. which African swine fever exists; or (c) Ruminants and swine, and fresh (ii) When a region allows the impor- (chilled or frozen) meats, prohibited tation or use of African swine fever importation under §§ 94.1, 94.8, 94.9, virus or cultures under conditions 94.10, 94.12, 94.14, or 94.18, which come which the Administrator has deter- into the United States by any means mined are less stringent than those other than ocean vessel, airplane, or prescribed by this chapter for the im- railroad car and are offered for entry portation or use of African swine fever and refused admission into this coun- virus or cultures into or within the try, shall be destroyed or otherwise United States; or disposed of as the Administrator may (iii) When a region has a contiguous direct, unless they are exported by the border with, or is subject to commer- consignee within 8 hours, and mean- cial exchange or natural spread of Afri- while are retained under such isolation can swine fever host animals, host ma- and other safeguards as the Adminis- terials, or vectors with, another region trator may require to prevent the in- with known outbreaks of African swine troduction or dissemination of live- fever; or stock diseases into the United States. (iv) A region’s lack of a disease de- (d) Ruminants and swine, and fresh tection, control, or reporting system (chilled or frozen) meats, prohibited capable of detecting or controlling Af- importation under §§ 94.1, 94.8, 94.9, rican swine fever and reporting it to 94.10, 94.12, 94.14, or 94.18, which come the United States in time to allow the

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United States to take appropriate ac- (2) Such pork or pork product is not tion to prevent the introduction of Af- otherwise prohibited importation rican swine fever into the United under this part and is consigned di- States; or rectly from the port of arrival in the (v) Any other fact or circumstance United States to a meat processing es- found to exist which constitutes a risk tablishment operating under Federal of introduction of African swine fever meat inspection, approved by the Ad- into the United States. ministrator, for further processing of (2) A list of regions where African such pork or pork product by heat. swine fever exists or the Administrator (3) Such pork or pork product: has reason to believe that African (i) Was processed in a single estab- swine fever exists is maintained on the lishment that meets the requirements in paragraph (b)(5) of this section. APHIS Web site at http:// (ii) Was heated by other than a flash- www.aphis.usda.gov/importlexport/ani- heating method to an internal tem- mals/animalldiseaselstatus.shtml. Cop- perature of at least 69 °C. (156 °F.) ies of the list will also be available via throughout after the bones had been postal mail, fax, or email upon request removed. to the Sanitary Trade Issues Team, Na- (iii) Is accompanied to the United tional Center for Import and Export, States by an original certificate stat- Veterinary Services, Animal and Plant ing that all of the requirements of this Health Inspection Service, 4700 River section have been met. The certificate Road Unit 38, Riverdale, Maryland must be written in English. The certifi- 20737. cate must be issued by an official of (3) APHIS will add a region to the the national government of the region list upon determining that the disease in which the processing establishment exists in the region based on reports is located. The official must be author- APHIS receives of outbreaks of the dis- ized to issue the foreign meat inspec- ease from veterinary officials of the ex- tion certificate required by part 327 of porting country, from the World Orga- chapter III of this title. Upon arrival of nization for Animal Health (OIE), or the pork or pork products in the from other sources the Administrator United States, the certificate must be determines to be reliable, or upon de- presented to an authorized inspector at termining that there is reason to be- the port of arrival. lieve the disease exists in the region. (4) The pork product is pork rind pel- APHIS will remove a region from the lets (pork skins) that were cooked in list after conducting an evaluation of one of the following ways in an estab- the region in accordance with § 92.2 of lishment that meets the requirements this subchapter and finding that the in paragraph (b)(5) of this section: disease is not present and that there is (i) One-step process. The pork skins no reason to believe the disease is must be cooked in oil for at least 80 present. In the case of a region for- minutes when oil temperature is con- merly not on this list that is added due sistently maintained at a minimum of to an outbreak, the region may be re- 114 °C. moved from the list in accordance with (ii) Two-step process. The pork skins the procedures for reestablishment of a must be dry-cooked at a minimum of region’s disease-free status in § 92.4 of 260 °C for approximately 210 minutes this subchapter. after which they must be cooked in hot (b) No pork or pork products may be oil (deep-fried) at a minimum of 104 °C imported into the United States from for an additional 150 minutes. any region listed in this section unless: (5) The processing establishment 8 in (1) Such pork or pork product has a region listed in this section must been fully cooked by a commercial method in a container hermetically 8 As a condition of entry into the United sealed promptly after filling but before States, pork or pork products must also meet all of the requirements of the Federal such cooking, so that such cooking and Meat Inspection Act (21 U.S.C. 601 et seq.) and sealing produced a fully-sterilized regulations thereunder (9 CFR, chapter III, product which is shelf-stable without part 327), including requirements that the refrigeration; or Continued

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comply with the following require- Finding Aids section of the printed volume ments: and at www.fdsys.gov. (i) All areas, utensils, and equipment likely to contact the pork or pork § 94.9 Pork and pork products from regions where classical swine fever products to be processed, including exists. skinning, deboning, cutting, and packing areas, and related utensils and (a) APHIS considers classical swine equipment, must be cleaned and dis- fever to exist in all regions of the world infected after processing pork or pork except those declared free of the disease by APHIS. products not eligible for export to the (1) A list of regions that APHIS has United States and before processing declared free of classical swine fever is any pork or pork products eligible for maintained on the APHIS Web site at export to the United States. http://www.aphis.usda.gov/importlexport/ (ii) Pork or pork products eligible for animals/animalldiseaselstatus.shtml. export to the United States may not be Copies of the list will also be available handled, cut, or otherwise processed at via postal mail, fax, or email upon re- the same time as any pork or pork quest to the Sanitary Trade Issues products not eligible for export to the Team, National Center for Import and United States. Export, Veterinary Services, Animal (iii) Pork or pork products eligible and Plant Health Inspection Service, for export to the United States must be 4700 River Road Unit 38, Riverdale, packed in clean new packaging that is Maryland 20737. clearly distinguishable from that con- (2) APHIS will add a region to the taining any pork or pork products not list of those it has declared free of clas- eligible for export to the United States. sical swine fever after it conducts an (c) Pork or pork products consigned evaluation of the region in accordance from the port of arrival to an approved with § 92.2 of this subchapter and finds establishment under the provisions of that the disease is not present. In the paragraph (b)(2) of this section shall be case of a region formerly on this list moved from the port of arrival to the that is removed due to an outbreak, approved establishment under Customs the region may be returned to the list seals or seals of the Administrator, and in accordance with the procedures for shall be otherwise handled as the Ad- reestablishment of a region’s disease- ministrator, may direct in order to free status in § 92.4 of this subchapter. guard against the introduction and dis- APHIS will remove a region from the semination of the contagion of African list of those it has declared free of clas- swine fever. Seals applied under this sical swine fever upon determining section shall not be broken except by that the disease exists in the region persons authorized to do so by the Ad- based on reports APHIS receives of ministrator. outbreaks of the disease from veteri- (d) Pork or pork products imported nary officials of the exporting country, into the United States from a region from the World Organization for Ani- listed in this section which do not meet mal Health (OIE), or from other the requirements specified in this sec- sources the Administrator determines tion shall be seized, quarantined, and to be reliable. disposed of as the Administrator, may (b) The APHIS-defined European CSF direct in order to guard against the in- region is a single region of low-risk for troduction and dissemination of the CSF. contagion of the disease. (c) Except as provided in § 94.24 for (Approved by the Office of Management and the APHIS-defined European CSF re- Budget under control number 0579–0015) gion, no fresh pork or pork product may be imported into the United [28 FR 5980, June 13, 1963] States from any region where classical EDITORIAL NOTE: For FEDERAL REGISTER ci- swine fever is known to exist unless it tations affecting § 94.8, see the List of CFR complies with the following require- Sections Affected, which appears in the ments: 9

pork or pork products be prepared only in 9 See also other provisions of this part and approved establishments. parts 93, 95, and 96 of this chapter, and part

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(1) Such pork or pork product has shipment from such free region: And, been treated in accordance with one of provided further, That the certificate the following procedures: required by paragraph (c)(3) of this sec- (i) Such pork and pork product has tion also states that: The container been fully cooked by a commercial seals specified in paragraph method in a container hermetically (c)(1)(iii)(C)(1) of this section were sealed promptly after filling but before found intact and free of any evidence of such cooking, so that such cooking and tampering on arrival at the processing sealing produced a fully sterilized prod- establishment by a national veterinary uct which is shelf-stable without re- inspector; and the processing establish- frigeration; ment from which the pork or pork (ii) Such pork or pork product is in product is shipped to the United States compliance with the following require- does not receive or process any live ments: swine, and uses only pork or pork prod- (A) All bones were completely re- uct which originates in regions listed moved prior to cooking; and under paragraph (a) of this section as (B) Such pork or pork product was free of classical swine fever and proc- heated by other than a flash-heating method to an internal temperature of esses all such pork or pork products in 69 °C. (156 °F.) throughout; accordance with paragraph (c)(1)(i), (iii) Such pork or pork product is in (ii), or (iii) of this section; or compliance with the following require- (iv) Pork rind pellets (pork skins) ments: originating in regions where classical (A) All bones have been completely swine fever is known to exist may be removed in the region of origin, and imported into the United States pro- (B) The meat has been held in an vided they have been cooked in one of unfrozen, fresh condition for at least 3 the following ways: days immediately following the slaugh- (A) One-step process. The pork skins ter of the animals from which it was must be cooked in oil for at least 80 derived, and minutes when oil temperature is con- (C) The meat has been thoroughly sistently maintained at a minimum of cured and fully dried for a period of not 114 °C. less than 90 days so that the product is (B) Two-step process. The pork skins shelf stable without refrigeration: Pro- must be dry-cooked at a minimum of vided, That the period of curing and 260 °C for approximately 210 minutes drying shall be 45 days if the pork or after which they must be cooked in hot pork product is accompanied to the oil (deep-fried) at a minimum of 104 °C processing establishment by a certifi- for an additional 150 minutes. cate of an official of the national gov- (2) Articles under paragraph (c)(1)(ii), ernment of a classical swine fever free (iii), or (iv) of this section were pre- region which specifies that: pared in an inspected establishment (1) The pork involved originated in that region and the pork or pork prod- that is eligible to have its products im- uct was consigned to a processing es- ported into the United States under tablishment in llllll (a region the Federal Meat Inspection Act and not listed under paragraph (a) of this § 327.2 of this title; and, section as free of classical swine fever), (3) In addition to the foreign meat in- in a closed container sealed by the na- spection certificate required by § 327.4 tional veterinary authorities of the of this title, pork and pork products classical swine fever free region by prepared under paragraph (c)(1)(ii), seals of a serially numbered type; and (iii), or (iv) of this section shall be ac- (2) The numbers of the seals used companied by a certificate that states were entered on the meat inspection that the provisions of paragraph certificate of the classical swine fever (c)(1)(ii), (iii), or (iv) of this section free region which accompanied the have been met. This certificate shall be issued by an official of the national 327 of this title, for other prohibitions and government of the region of origin who restrictions upon the importation of swine is authorized to issue the foreign meat and swine products. inspection certificate required by § 327.4

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of this title. 10 Upon arrival of the pork only after an official of that region’s or pork products in the United States, national government has determined the certificate must be presented to an that the seals are intact and free of authorized inspector at the port of ar- any evidence of tampering. rival. (2) Handling of uncooked pork and pork (4) Small amounts of pork or pork products. Establishments 11 in regions product, subject to the restrictions in where CSF is considered to exist that this section, may in specific cases be process uncooked pork or pork prod- imported for purposes of examination, ucts for export to the United States: testing, or analysis if the importer ap- (i) May not receive or handle any live plies for and receives written approval swine; for such importation from the Admin- (ii) May not receive, handle, or proc- istrator. Approval will be granted only ess uncooked pork or pork products when the Administrator determines that originate in regions affected with that the articles have been processed CSF; by heat in a manner so that such im- (iii) Must keep the certificate re- portation will not endanger the live- quired by paragraph (e)(1)(i) of this sec- stock of the United States. tion on file at the facility for a period (d) Thoroughly cured and fully dried of at least 2 years after export of proc- pork and pork products from regions essed products to the United States, where both classical swine fever and and must make those records available swine vesicular disease are known or to USDA inspectors during inspections; considered to exist need not comply and with paragraph (c)(1)(iii) of this section (iv) Must be evaluated and approved if they are in compliance with the pro- by APHIS through a site inspection. visions of § 94.12(b)(1)(iii) of this part. (3) Compliance agreement. The opera- (e) Uncooked pork or pork products tors of the processing establishment that originated in a region considered must sign a compliance agreement to be free of classical swine fever (CSF) with APHIS, stating that: and are processed in a region where (i) All meat processed for importa- CSF exists may be imported into the tion to the United States will be proc- United States under the following con- essed in accordance with the require- ditions: ments of this part; and (1) Shipment to approved establish- (ii) A full-time, salaried meat inspec- ments. (i) The uncooked pork or pork tion official of the national govern- products must be shipped from the ment of the region in which the proc- CSF-free region of origin in closed con- essing facility is located will supervise tainers sealed with serially numbered the processing and examination of the seals applied by an official of the na- product, and certify that it has been tional government of that region. They processed in accordance with this sec- must be accompanied by a certificate tion; and that is signed by an official of that region’s national government and that (iii) APHIS personnel or other per- specifies the product’s region of origin, sons authorized by the Administrator the name and number of the establish- may enter the establishment, unan- ment of origin, and the processing es- nounced, to inspect the establishment tablishment to which the uncooked and its records. pork or pork products are consigned, (4) Cooperative service agreement. The and the numbers of the seals applied to processing establishment, or a party on the shipping containers. its behalf, must enter into a coopera- (ii) The uncooked pork or pork prod- tive service agreement with APHIS to ucts may be removed from containers pay all expenses incurred by APHIS for at the processing establishment in the the initial evaluation of the processing region where CSF is considered to exist establishment and periodically thereafter, including travel, salary, subsistence, administrative overhead, and 10 The certification required may be placed other incidental expenses, including on the foreign meat inspection certificate prescribed by § 327.4 of this title or may be contained in a separate document. 11 See footnote 9.

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excess baggage up to 150 pounds. In ac- § 94.10 Swine from regions where clas- cordance with the terms of the cooper- sical swine fever exists. ative service agreement, before the (a) APHIS considers classical swine APHIS representative’s site inspection, fever to exist in all regions of the world the operator of the processing estab- except those declared free of the dis- lishment or the party acting on their ease by APHIS. behalf must deposit with the Adminis- (1) A list of regions that APHIS has trator an amount equal to the approxi- declared free of classical swine fever is mate cost of one inspection by an maintained on the APHIS Web site at APHIS representative, including trav- http://www.aphis.usda.gov/importlexport/ el, salary, subsistence, administrative animals/animalldiseaselstatus.shtml. overhead, and other incidental ex- Copies of the list will also be available penses, including excess baggage up to via postal mail, fax, or email upon re- 150 pounds. As funds from that amount quest to the Sanitary Trade Issues are obligated, a bill for costs incurred Team, National Center for Import and based on official accounting records Export, Veterinary Services, Animal will be issued to restore the deposit to and Plant Health Inspection Service, the original level, revised as necessary 4700 River Road, Unit 38, Riverdale, to allow for inflation or other changes Maryland 20737. in estimated costs. To be current, bills (2) APHIS will add a region to the must be paid within 14 days of receipt. list of those it has declared free of clas- (5) Shipment to the United States. sical swine fever after it conducts an Uncooked pork or pork products to be evaluation of the region in accordance imported into the United States must with § 92.2 of this subchapter and finds be shipped from the region where they that the disease is not present. In the were processed in closed containers case of a region formerly on this list sealed with serially numbered seals ap- that is removed due to an outbreak, plied by an official of the national gov- the region may be returned to the list ernment of that region. The shipments in accordance with the procedures for must be accompanied by a certificate reestablishment of a region’s disease- signed by an official of the national free status in § 92.4 of this subchapter. government of the region where the APHIS will remove a region from the pork or pork products were processed list of those it has declared free of clas- that lists the numbers of the seals ap- sical swine fever upon determining plied and states that all of the condi- that the disease exists in the region tions of this paragraph (e) have been based on reports APHIS receives of met. The certificate shall also state outbreaks of the disease from veteri- that the container seals specified in nary officials of the exporting country, paragraph (e)(1)(i) and (ii) of this sec- from the World Organization for Ani- tion were found by an official of the re- mal Health (OIE), or from other gion’s national government to be in- sources the Administrator determines tact and free of any evidence of tam- to be reliable. pering on arrival at the processing es- (b) The APHIS-defined European CSF tablishment in the CSF-affected re- region is a single region of low-risk for gion. A copy of this certificate must be CSF. kept on file at the processing establish- (c) Except as provided in § 94.24 for ment for at least 2 years. the APHIS-defined European CSF region, no swine that are moved from or (Approved by the Office of Management and transit any region where classical Budget under control numbers 0579–0015 and swine fever is known to exist may be 0579–0333) imported into the United States, ex- [37 FR 21149, Oct. 6, 1972] cept for wild swine imported into the United States in accordance with para- EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 94.9, see the List of CFR graph (d) of this section. Sections Affected, which appears in the (d) Wild swine may be allowed impor- Finding Aids section of the printed volume tation into the United States by the and at www.fdsys.gov. Administrator upon request in specific

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cases under § 93.501 or § 93.504(c) of this http://www.aphis.usda.gov/importlexport/ chapter. animals/animalldiseaselstatus.shtml. Copies of the list will also be available [71 FR 29070, May 19, 2006, as amended at 71 FR 31070, June 1, 2006; 72 FR 30470, June 1, via postal mail, fax, or email upon re- 2007; 72 FR 67232, Nov. 28, 2007; 75 FR 69857, quest to the Sanitary Trade Issues Nov. 16, 2010; 76 FR 70039, Nov. 10, 2011; 77 FR Team, National Center for Import and 1393, Jan. 10, 2012] Export, Veterinary Services, Animal and Plant Health Inspection Service, § 94.11 Restrictions on importation of 4700 River Road Unit 38, Riverdale, meat and other animal products Maryland 20737. from specified regions. (3) APHIS will add a region to the (a) The meat of ruminants or swine, list of those whose products are regu- and other animal products, and ship lated under this section after con- stores, airplane meals, and baggage ducting an evaluation of the region and containing such meat or animal prod- determining that one or more of the ucts originating in any region listed as circumstances described in paragraph provided in paragraph (a)(2) of this sec- (a)(1) of this section exists. APHIS will tion may not be imported into the remove a region from the list upon con- United States unless the requirements ducting an evaluation of the region and in this section, in addition to other ap- determining that the circumstances in plicable requirements of chapter III of paragraph (a)(1) of this section no this title, are met. However, meat and longer exist or upon determining that meat products that meet the require- rinderpest or foot-and-mouth disease ments of § 94.4 do not have to comply exists in the region. with the requirements of this section. (b) All meat or other animal product As used in this section, the term from such regions, whether in personal- ‘‘other animal product’’ means all use amounts or commercial lots (ex- parts of the carcass of any ruminant or cept that which has been fully cooked swine, other than meat and articles by a commercial method in a container regulated under part 95 or part 96 of hermetically sealed promptly after fill- this chapter. ing but before such cooking and sealing (1) The regions listed under para- produced a fully sterilized product graph (a)(2) of this section have been which is shelf-stable without refrigera- declared free of rinderpest and foot- tion) shall have been prepared only in and-mouth disease by APHIS as pro- an inspected establishment that is eli- vided in § 94.1(a) but supplement their gible to have its products imported national meat supply by the importa- into the United States under the Fed- tion of fresh (chilled or frozen) meat of eral Meat Inspection Act (21 U.S.C. 601 ruminants or swine from regions that et seq.) and the regulations in § 327.2, APHIS considers to be affected with chapter III of this title, issued there- rinderpest or foot-and-mouth disease as under, and shall be accompanied by a provided in § 94.1(a); or have a common Department-approved meat inspection land border with regions considered to certificate prescribed in § 327.4 in chap- be affected with rinderpest or foot-and- ter III of this title, or similar certifi- mouth disease; or import ruminants or cate approved by the Administrator, as swine from regions considered to be af- adequate to effectuate the purposes of fected with rinderpest or foot-and- this section, regardless of the purpose mouth disease under conditions less re- or amount of product in the shipment. strictive than would be acceptable for (c) Additional certification. Meat of importation into the United States. ruminants or swine or other animal Thus, the meat may be commingled products from any region listed under with the fresh (chilled or frozen) meat paragraph (a)(2) of this section must be of animals from an affected region, re- accompanied by additional certifi- sulting in an undue risk of introducing cation by a full-time salaried veteri- rinderpest or foot-and-mouth disease nary official of the agency in the na- into the United States. tional government that is responsible (2) A list of regions whose products for the health of the animals within are regulated under this section is that region. Upon arrival of the meat maintained on the APHIS Web site at of ruminants or swine or other animal

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product in the United States, the cer- § 94.12 Pork and pork products from tification must be presented to an au- regions where swine vesicular dis- thorized inspector at the port of ar- ease exists. rival. The certification must give the (a) APHIS considers swine vesicular name and official establishment num- disease to exist in all regions of the ber of the establishment where the ani- world except those declared free of the mals were slaughtered, and shall state disease by APHIS. that: (1) A list of regions that APHIS has (1) The slaughtering establishment is declared free of swine vesicular disease not permitted to receive animals that is maintained on the APHIS Web site originated in, or have ever been in, or at http://www.aphis.usda.gov/ that have been aboard a means of con- importlexport/animals/ veyance at the time such means of con- animalldiseaselstatus.shtml. Copies of veyance called at or landed at a port the list will also be available via postal in, a region designated under § 94.1(a) as mail, fax, or email upon request to the a region where rinderpest or foot-and- Sanitary Trade Issues Team, National mouth disease exists; Center for Import and Export, Veteri- (2) The slaughtering establishment is nary Services, Animal and Plant not permitted to receive meat or other Health Inspection Service, 4700 River animal products derived from Road Unit 38, Riverdale, Maryland ruminants or swine which originated in 20737. such a rinderpest or foot-and-mouth (2) APHIS will add a region to the disease affected region, or meat or list of those it has declared free of other animal products from a rinder- swine vesicular disease after it con- pest and foot-and-mouth disease free ducts an evaluation of the region in ac- region transported through a rinder- cordance with § 92.2 of this subchapter pest or foot-and-mouth disease affected and finds that the disease is not region except in containers sealed with present. In the case of a region for- serially numbered seals of the National merly on this list that is removed due Government of the noninfected region to an outbreak, the region may be re- of origin; turned to the list in accordance with (3) The meat or other animal product the procedures for reestablishment of a covered by the certificate was derived region’s disease-free status in § 92.4 of from animals born and raised in a re- this subchapter. APHIS will remove a gion listed under § 94.1(a) as free of rin- region from the list of those it has de- derpest and foot-and-mouth disease and clared free of swine vesicular disease the meat or other animal product has upon determining that the disease ex- never been in any region in which rin- ists in the region based on reports derpest or foot-and-mouth disease ex- APHIS receives of outbreaks of the dis- isted; ease from veterinary officials of the ex- (4) The meat or other animal product porting country, from the World Orga- has been processed, stored, and trans- nization for Animal Health (OIE), or ported to the means of conveyance that from other sources the Administrator will bring the article to the United determines to be reliable. States in a manner to preclude its (b) No pork or pork product may be being commingled or otherwise in con- imported into the United States from tact with meat or other animal prod- any region where swine vesicular dis- ucts that do not comply with the con- ease is known to exist unless it com- ditions contained in this certificate. plies with the following requirements and it is not otherwise prohibited im- (Approved by the Office of Management and portation into the United States under Budget under control number 0579–0015) this part: [38 FR 2752, Jan. 30, 1973] (1) Such pork or pork product has been treated in accordance with one of EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 94.11, see the List of CFR the following procedures: Sections Affected, which appears in the (i) Such pork or pork product has Finding Aids section of the printed volume been fully cooked by a commercial and at www.fdsys.gov. method in a container hermetically

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sealed promptly after filling, but be- free region, has been cured and dried fore such cooking, so that such cooking and is in compliance with the following and sealing produced a fully sterilized requirements: product which is shelf-stable without (A) All bones have been completely refrigeration. removed, either in the region of origin (ii) Such pork or pork product is in or in the region where the pork or pork compliance with the following require- products are processed; and ments: (B)(1) Such pork or pork product is (A) All bones were completely re- accompanied from the swine vesicular moved prior to cooking; and disease free region of origin to the (B) Such pork or pork product reprocessing establishment in the swine ceived heat treatment in a commer- vesicular disease affected region by a cially accepted manner used for perish- certificate signed by an official of the able canned pork products so that it National Government of the swine ve- reached an internal temperature of 69 sicular disease free region of origin °C. (156 °F.) throughout. specifying that the pork or pork prod- (iii) Such pork or pork product if uct involved originated in that region cured and dried is in compliance with and the pork or pork product was con- the following requirements: signed to a processing establishment in (A) All bones have been completely llllll (a region not listed under removed in the region of origin, and paragraph (a)(1) of this section as free (B) Such pork or pork products shall of swine vesicular disease), in a closed be consigned directly from the port of container sealed by the national veteri- entry in the United States to a meat nary authorities of the swine vesicular processing establishment operating disease free region of origin by seals of under Federal meat inspection and ap- a serially numbered type. The numbers proved by the Administrator, 12 for of these seals shall be entered on this heating to an internal temperature of certificate; and 166 °F. During movement from the port (2) The certificate required by para- of entry to the meat processing estab- graph (b)(3) of this section shall also lishment, the pork or pork products state that: must be moved under Department seals (i) The container seals specified in or seals of the U.S. Customs Service, paragraph (b)(1)(iv)(B)(1) of this section and shall be otherwise handled as the were found intact and free of any evi- Administrator may direct in order to dence of tampering on arrival at the guard against the introduction and dis- processing establishment in the swine semination of swine vesicular disease. vesicular disease affected region by a Seals applied under this section may national veterinary inspector of that not be broken except by persons au- region, thorized by the Administrator to do so. (ii) The processing establishment (iv) Such pork or pork product, if it from which the pork or pork product originated in a swine vesicular disease was shipped to the United States does not receive or process any live swine, 12 The names and addresses of approved es- and uses only pork or pork products tablishments may be obtained from, and re- which originate in regions listed under quest for approval of any establishment may paragraph (a)(1) of this section as free be made to, the Animal and Plant Health In- of swine vesicular disease; and spection Service, Veterinary Services, Na- tional Center for Import-Export, 4700 River (iii) That such establishment proc- Road Unit 38, Riverdale, Maryland 20737–1231. esses all such pork or pork products in Establishments will be approved only if the accordance with paragraph (b)(1)(i), Administrator determines that the imported (ii), (iii) or (iv) of this section. articles will be so handled at the establish- (v) Such pork or pork product is in ment as to prevent the introduction and dis- compliance with the following require- semination of livestock or poultry diseases ments: into the United States. Approval of any es- (A) All bones were completely re- tablishment may be refused or withdrawn only after the operator thereof has been moved prior to cooking; and given notice of the proposed action and has (B) Such pork or pork product re- had an opportunity to present his views ceived continual heat treatment in an thereon. oven for a minimum of 10 hours so that

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it reached an internal temperature of not endanger the livestock of the 65 °C. (149 °F.) throughout. The oven United States. temperature started at a minimum of (c) Requirements for pork-filled pasta 62 °C. (143.6 °F.) and reached at least 85 products from regions affected with swine °C. (185 °F.). vesicular disease. (1) Pork-filled pasta (vi) Pork rind pellets (pork skins) products processed for export to the must be cooked in one of the following United States may only be filled with ways: pork or pork products that are other- (A) One-step process. The pork skins wise eligible to be exported to the must be cooked in oil for at least 80 United States and that meet the re- minutes when oil temperature is con- quirements of paragraph (b)(1)(i), (ii), sistently maintained at a minimum of or (v) of this section or of § 94.17. 114 °C. (2) The operator of the pork-filled (B) Two-step process. The pork skins pasta processing facility must have must be dry-cooked at a minimum of signed a cooperative service agreement 260 °C for approximately 210 minutes with APHIS prior to receipt of the pork after which they must be cooked in hot oil (deep-fried) at a minimum of 104 °C intended to be used in pork-filled pasta for an additional 150 minutes. products, stating that all such pork (2) Articles under paragraph (b)(1)(ii), will be processed only in accordance (iii) or (iv) of this section were pre- with § 94.12 or § 94.17. Pursuant to the pared in an inspected establishment cooperative service agreement, the es- that is eligible to have its products im- tablishment must allow the unan- ported into the United States under nounced entry into the establishment the Federal Meat Inspection Act and of APHIS representatives, or other per- the regulations in § 327.2 in chapter III sons authorized by the Administrator, of this title. for the purpose of inspecting the facili- (3) In addition to the foreign meat in- ties, operations, and records of the es- spection certificate required in § 327.4 tablishment. The establishment must of this title, pork or pork products pre- be current in paying all costs for such pared under paragraph (b)(1)(ii), (iii) or inspections (it is anticipated that such (iv) of this section shall be accom- inspections will occur up to four times panied by certification that paragraph per year). These costs include travel, (b)(1)(ii), (b)(1)(iii)(A), or (b)(1)(iv)(B)(2) salary, subsistence, administrative of this section has been met. The cer- overhead, and other incidental ex- tification shall be issued by an official penses (including an excess baggage of the national government of the re- provision up to 150 pounds). In accord- gion of origin who is authorized to ance with the terms of the cooperative issue the foreign meat inspection cer- service agreement, the operator of the tificate required by § 327.4 of this processing establishment must deposit title. 13 Upon arrival of the pork or with the Administrator an amount pork products in the United States, the equal to the approximate costs for certificate must be presented to an au- APHIS to inspect the establishment thorized inspector at the port of ar- one time, including travel, salary, sub- rival. sistence, administrative overhead and (4) Small amounts of pork or pork other incidental expenses (including an product subject to the restrictions of excess baggage provision up to 150 this section, may in specific cases be pounds), and, as funds from that imported for purposes of examination, amount are obligated, bills for costs in- testing, or analysis, if the importer ap- curred based on official accounting plies for and receives written approval records will be issued to restore the de- for such importation from the Admin- posit to its original level. Amounts to istrator, authorizing such importation. restore the deposit to its original level Approval will be granted only when the must be paid within 14 days of receipt Administrator determines that the ar- of such bills. ticles have been processed by heat in a (3) At the pasta processing establish- manner so that such importation will ment, pork intended to be used for pork-filled pasta products for export to 13 See footnote 10. the United States must be stored apart

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from any meat or meat products not el- minimum of 2 years, an original record igible for export to the United States, of each lot of pork or pork products either in a separate storage room or fa- used for pork-filled pasta products for cility or in a separate area of the same export to the United States. Each storage room. Any storage room area record must include the following: reserved for pork or pork products eli- (i) The date that the cooked or dry- gible for export to the United States cured pork product was received in the must be separated by at least 1 meter processing facility; from any storage room area where (ii) The number of packages, the meat or meat products ineligible for number of hams or cooked pork prod- export to the United States are stored ucts per package, and the weight of and must be marked by signs and by each package; having its borders outlined on the (iii) A lot number or other identifica- floor. tion marks; (4) Prior to handling pork used for (iv) The health certificate that ac- pork-filled pasta products intended for companied the cooked or dry-cured export to the United States, workers at pork product from the slaughter/proc- the processing facility who handle pork essing facility to the meat-filled pasta or pork products in the facility must product processing facility; and shower and put on a full set of clean (v) The date that the pork or pork clothes, or wait 24 hours after handling product used in the pasta started dry pork or pork products that are not eli- curing (if the product used is a dry- gible for importation into the United cured ham) or the date that the prod- States. uct was cooked (if the product used is (5) All equipment and machinery that a cooked pork product). will come in contact with the pork or (10) The pork-filled pasta must be ac- other ingredients of pork-filled pasta companied by a certificate issued by an products intended for export to the official of the National Government of United States must be cleaned and dis- the region in which the pasta product infected before each use. is processed who is authorized to issue (6) Processing lines working with the foreign meat inspection certificate pork-filled pasta products for export to required under § 327.4 of this title, stat- the United States must be totally dedi- ing that the pork-filled pasta product cated to the production of such prod- has been processed in accordance with ucts for the time needed to complete a the requirements of this section. given lot. When any processing line in Upon arrival of the pork-filled pasta a facility is working with pork-filled in the United States, the certificate pasta products intended for export to must be presented to an inspector at the United States, no other processing the port of arrival. lines in the same facility may work on (Approved by the Office of Management and products using meat that is not eligible Budget under control numbers 0579–0015 and for export to the United States. 0579–0214) (7) Processing facilities that are com- [38 FR 20610, Aug. 2, 1973] pletely dedicated to producing only pork-filled pasta products for export to EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 94.12, see the List of CFR the United States and do not receive, Sections Affected, which appears in the handle, or process any animal product Finding Aids section of the printed volume not intended for export to the United and at www.fdsys.gov. States are exempt from the requirements of paragraphs (c)(3) through § 94.13 Restrictions on importation of (c)(6) of this section. pork or pork products from speci- (8) During processing, the pork-filled fied regions. pasta must be steam-heated to a min- (a) Pork or pork products and ship’s imum internal temperature of 90 °C, stores, airplane meals, and baggage then dried, cooled, and packed to make containing pork or pork products, the product shelf stable without refrig- other than those articles regulated eration. under part 95 or part 96 of this chapter, (9) The processing facility must produced in any region listed under maintain under lock and key, for a paragraph (a)(2) of this section may not

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be imported into the United States unaccompanied by the foreign meat in- less the requirements of this section, in spection certificate required by § 327.4 addition to other applicable require- of this title. Upon arrival of the pork ments of part 327 of this title, are met. or pork products in the United States, (1) The regions listed under para- the foreign meat inspection certificate graph (a)(2) of this section have been must be presented to an authorized in- declared free of swine vesicular disease spector at the port of arrival. as provided in § 94.12(a) but supplement (c) Unless such pork or pork products their national pork supply by the im- are treated according to one of the pro- portation of fresh (chilled or frozen) cedures described in § 94.12(b) of this meat of animals from regions where part, the pork or pork products must swine vesicular disease is considered to be accompanied by an additional cer- exist, or have a common border with tificate issued by a full-time salaried such regions, or have trade practices veterinary official of the agency in the that are less restrictive than are ac- national government responsible for ceptable to the United States. Thus, the health of the animals within that the pork or pork products may be com- region. Upon arrival of the pork or mingled with fresh (chilled or frozen) pork products in the United States, the meat of animals from a region where certificate must be presented to an au- swine vesicular disease is considered to thorized inspector at the port of ar- exist, resulting in an undue risk of rival. The certificate shall state the swine vesicular disease introduction name and official establishment num- into the United States. ber of the establishment where the (2) A list of regions whose products are regulated under this section is swine involved were slaughtered and maintained on the APHIS Web site at the pork was processed. The certificate http://www.aphis.usda.gov/importlexport/ shall also state that: animals/animalldiseaselstatus.shtml. (1) The slaughtering establishment is Copies of the list will also be available not permitted to receive animals that via postal mail, fax, or email upon re- originated in a region considered to quest to the Sanitary Trade Issues have swine vesicular disease or that Team, National Center for Import and have ever been in a region in which Export, Veterinary Services, Animal swine vesicular disease existed. and Plant Health Inspection Service, (2) The slaughtering establishment is 4700 River Road Unit 38, Riverdale, not permitted to receive pork derived Maryland 20737. from swine which originated in such a (3) APHIS will add a region to the region or pork from swine from a swine list of those whose products are regu- vesicular disease free region which has lated under this section after con- been transported through a region ducting an evaluation of the region and where swine vesicular disease is consid- determining that one or more of the ered to exist except pork which was circumstances listed in paragraph transported in containers sealed with (a)(1) of this section exists. APHIS will serially numbered seals of the National remove a region from the list upon con- Government of a region of origin listed ducting an evaluation of the region and under § 94.12(a) as a region considered determining that the circumstances in free of the disease. paragraph (a)(1) of this section no (3) The pork has been processed, longer exist or upon determining that stored, and transported to the means of swine vesicular disease exists in the re- conveyance that will bring the article gion. to the United States in a manner that (b) All such pork or pork products, precludes its being commingled or oth- except those treated in accordance erwise coming in contact with pork or with § 94.12(b)(1)(i) of this part, shall pork products that have not been han- have been prepared only in inspected dled in accordance with the require- establishments that are eligible to ments of this section. have their products imported into the United States under the Federal Meat (Approved by the Office of Management and Inspection Act (21 U.S.C. 601 et seq.) and Budget under control number 0579–0015) under § 327.2 of this title and shall be [38 FR 20611, Aug. 2, 1973]

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EDITORIAL NOTE: For FEDERAL REGISTER ci- and Yucatan, Mexico, that are not eli- tations affecting § 94.13, see the List of CFR gible for entry into the United States Sections Affected, which appears in the in accordance with this part may tran- Finding Aids section of the printed volume and at www.fdsys.gov. sit the United States via land border ports for immediate export if the fol- § 94.14 Swine from regions where lowing conditions are met: swine vesicular disease exists; im- (1) The person desiring to move the portations prohibited. pork and pork products through the (a) Swine vesicular disease is known United States obtains a United States to exist in all regions of the world ex- Veterinary Permit for Importation and cept those listed under § 94.12(a) of this Transportation of Controlled Materials part. No swine which are moved from and Organisms and Vectors (VS Form or transit any region in which swine 16–6). (An application for the permit vesicular disease is known to exist may may be obtained from the Animal and be imported into the United States ex- Plant Health Inspection Service, Vet- cept wild swine imported in accordance erinary Services, National Center for with paragraph (b) of this section. Import-Export, 4700 River Road Unit 38, (b) Wild swine may be allowed impor- Riverdale, Maryland 20737–1231.) tation into the United States by the (2) The pork or pork products are Administrator upon request in specific packaged at a Tipo Inspeccio´ n Federal cases under § 93.501 or § 93.504(c) of this plant in Baja California, Baja Cali- chapter. fornia Sur, Campeche, Chihuahua, (Approved by the Office of Management and Coahuila, Nuevo Leon, Quintana Roo, Budget under control number 0579–0040) Sinaloa, Sonora, or Yucatan, Mexico, [54 FR 7395, Feb. 21, 1989, as amended at 55 in leakproof containers and sealed with FR 31558, Aug. 2, 1990; 59 FR 67134, Dec. 29, serially numbered seals of the Govern- 1994; 62 FR 56023, Oct. 28, 1997; 77 FR 1394, ment of Mexico, and the containers re- Jan. 10, 2012] main sealed during the entire time they are in transit across Mexico and § 94.15 Animal products and materials; the United States. movement and handling. (3) The person moving the pork and (a) Any animal product or material pork products through the United which would be eligible for entry into States notifies, in writing, the Plant the United States, as specified in the Protection and Quarantine Officer at regulations in this part, may transit the United States port of arrival prior through the United States for imme- to such transiting. The notification diate export if the following conditions must include the following information are met: regarding the pork and pork products: (1) Notification of the transiting of (i) Permit number; such animal product or material must be made by the importer to the Plant (ii) Times and dates of arrival in the Protection and Quarantine Officer at United States; the United States port of arrival prior (iii) Time schedule and route to be to such transiting, and followed through the United States; (2) The animal product or material and transited shall be contained in a (iv) Serial numbers of the seals on sealed, leakproof carrier or container the containers. which shall remain sealed while aboard (4) The pork and pork products tran- the transporting carrier or other sit the United States under Customs means of conveyance, or if the con- bond and are exported from the United tainer or carrier in which such animal States within the time limit specified product or material is transported is on the permit. Any pork or pork prod- offloaded in the United States for re- ucts that have not been exported with- shipment, it shall remain sealed at all in the time limit specified on the per- times. mit or that have not been transited in (b) Pork and pork products from Baja accordance with the permit or applica- California, Baja California Sur, ble requirements of this part will be de- Campeche, Chihuahua, Coahuila, Nuevo stroyed or otherwise disposed of as the Leon, Quintana Roo, Sinaloa, Sonora, Administrator may direct pursuant to

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the Animal Health Protection Act (7 ported from the United States within U.S.C. 8301 et seq.). the time limit specified on the permit. (c) Poultry carcasses, parts, or prod- Any poultry carcasses, parts, or products (except eggs and egg products) ucts that have not been exported with- from Baja California, Baja California in the time limit specified on the per- Sur, Campeche, Chihuahua, Nuevo mit or that have not transited in ac- Leon, Quintana Roo, Sinaloa, Sonora, cordance with the permit or applicable Tamaulipas, or Yucatan, Mexico, that requirements of this part will be de- are not eligible for entry into the stroyed or otherwise disposed of as the United States in accordance with the Administrator may direct pursuant to regulations in this part may transit the United States via land ports for im- the Animal Health Protection Act (7 mediate export if the following condi- U.S.C. 8301 et seq.). tions are met: (d) Meat and other products of (1) The person desiring to move the ruminants or swine from regions listed poultry carcasses, parts, or products in § 94.11(a) and pork and pork products through the United States obtains a from regions listed in § 94.13 that do not United States Veterinary Permit for meet the requirements of § 94.11(b) or Importation and Transportation of § 94.13(a) may transit through the Controlled Materials and Organisms United States for immediate export, and Vectors (VS Form 16–6). An appli- provided the provisions of paragraph cation for the permit may be obtained (a) of this section are met, and pro- from the Animal and Plant Health In- vided all other applicable provisions of spection Service, Veterinary Services, this part are met. National Center for Import-Export, (e) Any meat or other animal prod- 4700 River Road Unit 38, Riverdale, ucts not otherwise eligible for entry Maryland 20737–1231. into the United States, as provided in (2) The poultry carcasses, parts, or products are packaged at a Tipo this part and part 95 of this chapter, Inspeccioo´ n Federal plant in Baja Cali- may transit the United States for im- fornia, Baja California Sur, Campeche, mediate export if the following condi- Chihuahua, Nuevo Leon, Quintana Roo, tions are met: Sinaloa, Sonora, Tamaulipas, or Yuca- (1) Notification of the transiting of tan, Mexico, in leakproof containers such meat or other animal product is with serially numbered seals of the made by the importer to the Plant Pro- Government of Mexico, and the con- tection and Quarantine officer at the tainers remain sealed during the entire United States port of arrival prior to time they are in transit across Mexico such transiting; and the United States. (2) The meat or other animal product (3) The person moving the poultry is contained in a sealed, leakproof car- carcasses, parts, or products through rier or container, which remains sealed the United States notifies, in writing, while aboard the transporting carrier the Plant Protection and Quarantine or other means of conveyance, or, if Officer at the U.S. port of arrival prior the container or carrier in which the to such transiting. The notification must include the following information meat or other animal product is trans- regarding the poultry to transit the ported is offloaded in the United States United States: for reshipment, it remains sealed at all (i) Permit number; times; (ii) Times and dates of arrival in the (3) Such transit is limited to the United States; maritime or airport port of arrival (iii) Time schedule and route to be only, with no overland movement out- followed through the United States; side the airport terminal area or dock and area of the maritime port; and (iv) Serial numbers of the seals on (4) The meat or other animal product the containers. is not held or stored for more than 72 (4) The poultry carcasses, parts, or products transit the United States under U.S. Customs bond and are ex-

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hours at the maritime or airport port house 14 under the supervision of an in- of arrival. spector of the Animal and Plant Health Inspection Service pending movement (Approved by the Office of Management and Budget under control numbers 0579–0040 and to an approved establishment. Such 0579–0145) products shall be transported from the United States port of first arrival to an [43 FR 4595, Feb. 3, 1978, as amended at 57 FR approved establishment 14 or an ap- 23928, June 5, 1992; 57 FR 43886, Sept. 23, 1992; proved warehouse, 14 and from an ap- 59 FR 67616, Dec. 30, 1994; 60 FR 57315, Nov. 15, 14 1995; 61 FR 32647, June 25, 1996; 62 FR 24804, proved warehouse to an approved es- May 7, 1997; 62 FR 56023, Oct. 28, 1997; 65 FR tablishment 14 only under Department 37270, June 14, 2000; 65 FR 50605, Aug. 21, 2000; seals or seals of the U.S. Customs Serv- 68 FR 6345, Feb. 7, 2003] ice. Such seals shall be broken only by such an inspector or other person au- § 94.16 Milk and milk products. thorized to do so by the Administrator. (a) The following milk products are Such products shall not be removed exempt from the provisions of this from the approved warehouse 14 or ap- part: proved establishment 14 except upon (1) Cheese, but not including cheese special permission by the Adminis- with liquid and not including cheese trator, and upon compliance with all containing any item that is regulated by other sections of this part, unless such item is independently eligible for 14 The names and addresses of approved es- importation into the United States tablishments or warehouses or information under this part; as to approved manner of processing, and re- (2) Butter; and quest for approval of any such establish- (3) Butteroil. ment, warehouse, or manner of processing may be made to the Animal and Plant (b) Milk and milk products origi- Health Inspection Service, Veterinary Serv- nating in, or shipped from, any region ices, National Center for Import-Export, 4700 where rinderpest or foot-and-mouth River Road Unit 38, Riverdale, Maryland disease is considered to exist under 20737–1231. Any establishment or warehouse § 94.1(a) may be imported into the will be approved for the purpose of this sec- United States if they meet the require- tion only if the operator has provided the Administrator, with satisfactory evidence ments of paragraphs (b)(1), (2), or (3) of that the establishment or warehouse has the this section: equipment, facilities, and capability to (1) They are in a concentrated liquid store, handle and process the imported dry form and have been processed by heat milk or dry milk product subject to by a commercial method in a container § 94.16(b)(2) in a manner which will prevent the introduction or dissemination of live- hermetically sealed promptly after fill- stock diseases into the United States. Simi- ing but before such heating, so as to be larly, processing methods will be approved shelf stable without refrigeration. only if the Administrator determines they (2) They are dry milk or dry milk are adequate to prevent the introduction or products, including dry whole milk, dissemination of such diseases into the United States. Approval of any establish- nonfat dry milk, dried whey, dried but- ment or warehouse or processing method termilk, and formulations which con- may be refused or withdrawn by the Admin- tain any such dry milk products, and istrator only after the operator thereof has are consigned directly to an approved been given notice of the proposed action and establishment 14 for further processing has had an opportunity to present his views in a manner approved by the Adminis- thereon, and upon a determination by the Administrator that the conditions for ap- trator, as adequate to prevent the in- proval are not met. Approval of an establish- troduction or dissemination of live- ment or warehouse may also be withdrawn stock diseases into the United States. after such notice and opportunity if the Ad- However, in specific cases, upon re- ministrator determines that such imported quest by the importer to the Adminis- dry milk or milk products have been stored, trator, and approval by the Adminis- handled, or processed by the operator thereof other than at an approved establishment or trator, they may be stored for a tem- warehouse or other than in an approved porary period in an approved ware- manner.

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the conditions and requirements speci- (2) The numbers of such seals are list- fied by him for such movement in each ed on, or are on a list attached to, the specific case. bill of lading or similar document ac- (3) Milk and milk products not ex- companying the shipment. empted under paragraph (a) and not of (3) Upon arrival of the carrier at the classes included within the provisions United States port, an inspector of the of paragraphs (b)(1) or (2) of this sec- Animal and Plant Health Inspection tion may be imported if the importer Service determines that the seals are first applies to and receives written intact and that their numbers are in permission from the Administrator, au- agreement with the numbers appearing thorizing such importation. Permission on the accompanying document; Pro- will be granted only when the Adminis- vided, That, if the representative finds trator determines that such action will that any seal has been broken or has a not endanger the health of the live- different number than is recorded on stock of the United States. Products the accompanying document, then the subject to this provision include but milk or milk products may remain eli- are not limited to condensed milk, gible for entry into the United States long-life milks such as sterilized milk, only if APHIS personnel are available casein and caseinates, lactose, and lac- to inspect the hold, compartment, or talbumin. container, the cartons or other con- (4) Small amounts of milk and milk tainers of milk or milk products, and products subject to the restrictions of all accompanying documentation; and this part may in specific cases be im- the importer furnishes additional docu- ported for purposes of examination, mentation (either copies of pages from testing, or analysis, if the importer ap- the ship’s log signed by the officer-in- plies to and receives written approval charge, or certification from a foreign for such importation from the Admin- government that the original seal was istrator. Approval will be granted only removed and the new seal applied by when the Administrator determines officials of the government) that dem- that such action will not endanger the onstrates to the satisfaction of the Ad- health of the livestock of the United ministrator that the milk or milk States. products were not contaminated or ex- (c) Milk and milk products origi- posed to contamination during move- nating in and shipped from regions list- ment from the region of origin to the ed under § 94.1(a) as free of rinderpest United States. and foot-and-mouth disease but which (d) Except for milk and milk prod- have entered a port or otherwise ucts imported from Canada, and except transited a region where APHIS con- as provided in this paragraph, milk or siders either disease to exist may not milk products imported from a region be imported into the United States un- listed under § 94.1(a) as free of rinder- less: pest and foot-and-mouth disease must (1) The product was transported be accompanied by a certificate en- under serially numbered official seals dorsed by a full-time, salaried veteri- applied at the point of origin of the narian employed by the region of ex- shipment by an authorized representa- port. The certificate must state that tive of the region of such origin; except the milk was produced and processed in that, if any seal applied at the point of a region listed under § 94.1(a) as free of origin was broken by any foreign offi- rinderpest and foot-and-mouth disease, cial to inspect the shipment, an au- or that the milk product was processed thorized representative of that region in one such region from milk produced applied a new serially numbered offi- in another such region. The certificate cial seal to the hold, compartment, or must name the region in which the container in which the milk or milk milk was produced and the region in products were transported; and if any which the milk or milk product was member of a ship’s crew broke a seal, processed. Further, the certificate the serial number of the seal, the loca- must state that, except for movement tion of the seal, and the reason for under seal as described in § 94.16(c), the breaking the seal were recorded in the milk or milk product has never been in ship’s log. a region in which rinderpest or foot-

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and-mouth disease exists. Milk or milk (d) The whole ham, pork shoulder, or products from a region listed under pork loin was accompanied from the § 94.1(a) as free of rinderpest and foot- slaughtering facility to the processing and-mouth disease and that were proc- establishment by a numbered certifi- essed in whole or in part from milk or cate issued by a person authorized by milk products from a region not listed the government of the region of origin under § 94.1(a) as free of rinderpest and stating that the provisions of para- foot-and-mouth disease may be im- graphs (a) and (c) of this section have ported into the United States only in been met; accordance with paragraph (b)(3) of (e) The ham, pork shoulder, or pork this section. loin was processed whole as set forth in (Approved by the Office of Management and paragraph (i) of this section in only one Budget under control number 0579–0015) processing establishment;15 [40 FR 44123, Sept. 25, 1975] (f) The ham, pork shoulder, or pork loin was processed whole in a proc- EDITORIAL NOTE: For FEDERAL REGISTER ci- essing establishment that prior to the tations affecting § 94.16, see the List of CFR processing of any hams, pork shoul- Sections Affected, which appears in the Finding Aids section of the printed volume ders, or pork loins in accordance with and at www.fdsys.gov. this section, was inspected by a veterinarian of APHIS and determined by the § 94.17 Dry-cured pork products from Administrator, to be capable of meet- regions where foot-and-mouth dis- ing the provisions of this section for ease, rinderpest, African swine processing hams, pork shoulders, or fever, classical swine fever, or pork loins for importation into the swine vesicular disease exists. United States; Notwithstanding any other provi- (g) The ham, pork shoulder, or pork sions in this part, dry-cured ham, pork loin was processed whole in a proc- shoulder, or pork loin, whether whole essing establishment for which the op- or sliced and packaged, shall not be erator of the establishment has signed prohibited from being imported into an agreement with APHIS prior to re- the United States if it meets the fol- ceipt of the hams, pork shoulders, or lowing conditions: pork loins for processing, stating that (a) Except for Italian-type hams, all hams, pork shoulders, or pork loins Serrano hams, Iberian hams, Iberian processed for importation into the pork shoulders, and Iberian pork loins United States will be processed only in that have been processed in accordance accordance with the provisions of this with paragraph (i) of this section, the part; dry-cured ham, pork shoulder, or pork (h) Workers who handle fresh pork in loin came from a swine that was never the processing establishment where the out of the region in which the dry- dry-cured ham, pork shoulder, or pork cured ham, pork shoulder, or pork loin loin was processed whole are required was processed; to shower and put on a full set of clean (b) The ham, pork shoulder, or pork clothes, or to wait 24 hours after han- loin came from a region determined by dling fresh pork, before handling hams, the Administrator, to have and to en- pork shoulders, or pork loins that have force laws requiring the immediate re- progressed in the aging/curing process porting to the national veterinary as follows: services in that region any premises (1) In the case of Italian-type hams found to have any animal infected with processed in accordance with para- foot-and-mouth disease, rinderpest, Af- graph (i)(1) of this section, those that rican Swine fever, classical swine fever, or swine vesicular disease; (c) The ham, pork shoulder, or pork 15 As a condition of entry into the United loin came from a swine that was not on States, pork and pork products must also any premises where foot-and-mouth meet all of the requirements of the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) and disease, rinderpest, African swine regulations thereunder (9 CFR, chapter III), fever, classical swine fever, or swine including requirements that the pork or vesicular disease exists or had existed pork products be prepared only in approved within 60 days prior to slaughter; establishments.

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have progressed beyond the final wash for 5–7 days at a temperature of 15–23 stage; °C. (59–73.4 °F.) and a relative humidity (2) In the case of Serrano hams or of 55–85 percent; thereafter the ham Iberian hams or pork shoulders proc- was placed for curing in a chamber essed in accordance with paragraphs maintained for a minimum of 314 days (i)(2), (i)(3), or (i)(4) of this section, at a temperature of 15–20 °C. (59–68 °F.) those that have progressed beyond salt- and at a relative humidity of 65–80 pering; and cent at the beginning and increased by (3) In the case of Iberian pork loins 5 percent every 21⁄2 months until a rel- processed in accordance with para- ative humidity of 85 percent was graph (i)(5) of this section, those that reached. have progressed beyond being placed in (2) Serrano hams. Serrano hams were a casing. processed as follows (190-day minimum (i) The dry-cured ham, pork shoulder, curing process): or pork loin was processed whole in ac- (i) If the ham is received frozen, it cordance with this paragraph. Except was thawed in a chamber with relative for pork fat treated to at least 76 °C humidity between 70 and 80 percent, (168.8 °F), which may have been placed with room temperature maintained at over the meat during curing, the dry- 12 °C to 13 °C (53.6 °F to 55.4 °F) for the cured pork product must have had no first 24 hours, then at 13 °C to 14 °C (55.4 contact with any other meat or animal °F to 57.2 °F) until the internal tem- product during processing. perature of the ham reached 3 °C to 4 °C (1) Italian-type hams. The ham was (37.4 °F to 39.2 °F), at which point the processed for a period of not less than blood vessels at the end of the femur 400 days in accordance with the fol- were massaged to remove any remain- lowing conditions: after slaughter the ing blood. ham was held at a temperature of 0–3 (ii) The ham was covered in salt and °C. (32–34.7 °F) for a minimum of 72 placed in a chamber maintained at a hours during which time the ‘‘aitch’’ temperature from 0 °C to 4 °C (32 °F to bone and the foot was removed and the 39.2 °F), with relative humidity be- blood vessels at the end of the femur tween 75 and 95 percent, for a period no were massaged to remove any remain- less than 0.65 days per kg and no more ing blood; thereafter the ham was cov- than 2 days per kg of the weight of the ered with an amount of salt equal to 4– ham. 6 percent of the weight of the ham, (iii) The ham was rinsed with water with a sufficient amount of water and/or brushed to remove any remain- added to ensure that the salt had ad- ing surface salt. hered to the ham; thereafter the ham (iv) The ham was placed in a chamber was placed for 5–7 days on racks in a maintained at a temperature of 0 °C to chamber maintained at a temperature 6 °C (32 °F to 42.8 °F), with a relative of 0–4 °C. (32–39.2 °F) and at a relative humidity of 70 to 95 percent, for no less humidity of 70–85 percent; thereafter than 40 and no more than 60 days; the ham was covered with an amount (v) The ham was placed for curing in of salt equal to 4–6 percent of the a chamber with a relative humidity of weight of the ham, with a sufficient 60 to 80 percent and a temperature amount of water added to ensure that gradually raised in 3 phases, as follows: the salt had adhered to the ham; there- (A) A temperature of 6 °C to 16 °C after the ham was placed for 21 days in (42.8 °F to 60.8 °F), maintained for a a chamber maintained at a tempera- minimum of 45 days; ture of 0–4 °C. (32–39.2 °F.) and at a rel- (B) A temperature of 16 °C to 24 °C ative humidity of 70–85 percent; there- (60.8 °F to 75.2 °F), maintained for a after the salt was brushed off the ham; minimum of 35 days; thereafter the ham was placed in a (C) A temperature of 24 °C to 34 °C chamber maintained at a temperature (75.2 °F to 93.2 °F), maintained for a of 1–6 °C. (33.8–42.8 °F.) and at a relative minimum of 30 days; humidity of 65–80 percent for between (vi) Finally, with the relative humid- 52 and 72 days; thereafter the ham was ity unchanged at 60 to 80 percent, the brushed and rinsed with water; there- temperature was lowered to 12 °C to 20 after the ham was placed in a chamber °C (53.6 °F to 68 °F) and maintained at

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that level for a minimum of 35 days, at least 560 days after the start of the until at least 190 days after the start of curing process. the curing process; Except that: In a re- (4) Iberian pork shoulders. Iberian gion where swine vesicular disease ex- pork shoulders were processed as fol- ists, the ham must be maintained at lows (240-day minimum curing process): that level an additional 370 days, until (i) If the pork shoulder is received at least 560 days after the start of the frozen, it was thawed at a room tem- curing process. perature of 12 °C to 13 °C (53.6 °F to 55.4 (3) Iberian hams. Iberian hams were °F), with the relative humidity be- processed as follows (365-day minimum tween 75 and 85 percent, for approxi- curing process): mately 24 hours, until the internal (i) If the ham is received frozen, it temperature reached 3 °C to 4 °C (37.4 was thawed in a chamber with relative °F to 39.2 °F), at which point the blood humidity between 70 and 80 percent, vessels in the scapular region were with room temperature maintained at massaged to remove any remaining 5.5 °C to 6.5 °C (41.9 °F to 43.7 °F) for the blood. first 24 hours, then at 9.5 °C to 10.5 °C (ii) The pork shoulder was covered in (49.1 °F to 50.9 °F) until the internal salt and placed in a chamber main- ° ° temperature of the ham reached 3 °C to tained at a temperature of 0 C to 4 C ° ° 4 °C (37.4 °F to 39.2 °F), at which point (32 F to 39.2 F) with the relative hu- the blood vessels at the end of the midity between 75 and 95 percent, for a femur were massaged to remove any re- period of no less than 0.65 days per kg maining blood. and no more than 2 days per kg of the weight of the pork shoulder. (ii) The ham was covered in salt and (iii) The pork shoulder was rinsed placed in a chamber maintained at a with water and/or brushed to remove temperature from 0 °C to 4 °C (32 °F to any remaining surface salt. 39.2 °F), with relative humidity be- (iv) The pork shoulder was placed in tween 75 and 95 percent, and kept in a chamber maintained at a tempera- the chamber for a period no less than ture of 0 °C to 6 °C (32 °F to 42.8 °F) and 0.65 days per kg and no more than 2 a relative humidity of 70 to 95 percent days per kg of the weight of the ham; for not less than 40 days and not more (iii) The ham was rinsed with water than 60 days. and/or brushed to remove any remain- (v) The pork shoulder was placed for ing surface salt. curing in a chamber at a temperature (iv) The ham was placed in a chamber of 6 °C to 16 °C (42.8 °F to 60.8 °F) and maintained at a temperature of 0 °C to a relative humidity of 60 to 80 percent 6 °C (32 °F to 42.8 °F), with relative hu- for a minimum of 90 days. midity of 70 to 95 percent, for no less (vi) The temperature was raised to 16 than 40 and no more than 60 days. °C to 26 °C (60.8 °F to 78.8 °F) and the (v) The ham was placed for curing in relative humidity was changed to 55 to a chamber with a temperature of 6 °C 85 percent, and those levels were main- to 16 °C (42.8 °F to 60.8 °F) and relative tained for a minimum of 90 days. humidity of 60 to 80 percent for a min- (vii) Finally, the temperature was re- imum of 90 days. duced to 12 °C to 22 °C (53.6 °F to 71.6 (vi) The temperature was raised to 16 °F) and the relative humidity was °C to 26 °C (60.8 °F to 78.8 °F) and the raised to 60 to 90 percent for a min- relative humidity reduced to 55 to 85 imum of 45 days, until at least 240 days percent, for a minimum of 90 days. after the start of the curing process. (vii) Finally, with the relative hu- (5) Iberian pork loins. Iberian pork midity raised to 60 to 90 percent, the loins were processed as follows (130-day temperature was lowered to 12 °C to 22 minimum curing process): °C (53.6 °F to 71.6 °F) and maintained at (i) If the pork loin is received frozen, that level for a minimum of 115 days, it was thawed at a room temperature until at least 365 days after the start of maintained at 11 °C to 12 °C (51.8 °F to the curing process; Except that: In a re- 53.6 °F), with the relative humidity be- gion where swine vesicular disease ex- tween 70 and 80 per cent for the first 24 ists, the ham must be maintained at hours, then between 75 and 85 percent, that level an additional 195 days, until until the loin’s internal temperature

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reached 3 °C to 4 °C (37.4 °F to 39.2 °F), lishment immediately prior to salting, at which point the external fat, under the supervision of a person au- aponeurosis, and tendons were cleaned thorized to supervise such activity by from the loin. the veterinary services of the national (ii) The pork loin was covered in a government of the region of origin; pickle preparation (25–30 grams of salt (2) The whole dry-cured ham, if it is for each kilogram of pork loin) and processed in accordance with para- placed in a chamber where it was main- graphs (i)(2) or (i)(3) of this section, or tained at a relative humidity of 75 to 95 the whole dry-cured pork shoulder, if it percent and a temperature of 3 °C to 4 is processed in accordance with para- °C (37.4 °F to 39.2 °F) for 72 hours. graph (i)(4) of this section, bears an ink (iii) The pork loin was removed from seal (with the identifying number of the pickle preparation (25–30 grams of the slaughtering establishment) which salt for each kilogram of pork loin), ex- was placed thereon at the slaughtering ternally cleaned (brushed or rinsed), establishment under the direct super- placed in an artificial casing, and fas- vision of a person authorized to super- tened shut with a metal clip. vise such activity by the veterinary (iv) The pork loin was placed for cur- services of the national government of ing in a chamber with a relative hu- the region of origin, and an ink seal midity of 60 to 90 percent and a tem- (with the identifying number of the perature gradually raised in 3 phases, processing establishment and the date as follows: the salting began) which was placed (A) A temperature of 2 °C to 6 °C (35.6 thereon at the processing establish- °F to 42.8 °F), maintained for a min- ment, immediately prior to salting, imum of 20 days; under the supervision of a person au- (B) A temperature of 6 °C to 15 °C thorized to supervise such activity by (42.8 °F to 59.0 °F), maintained for a the veterinary services of the national minimum of 20 days; government of the region of origin; or (C) A temperature of 15 °C to 25 °C (3) The whole dry-cured pork loin, if (59.0 °F to 77.0 °F), maintained for a it is processed in accordance with para- minimum of 40 days; graph (i)(5) of this section, is packaged (v) Finally, with the relative humid- with material that bears a seal of the ity unchanged at 60 to 80 percent and government of the region of origin the temperature lowered to 0 °C to 5 °C which was placed thereon at the (32.0 °F to 41.0 °F), the pork loin was slaughtering establishment under the vacuum-packed and maintained under direct supervision of a person author- those conditions for a minimum of 15 ized to supervise such activity by the days, until at least 130 days after the veterinary services of the national gov- start of the curing process. ernment of the region of origin, and (j)(1) The whole ham, if it is Italian- bears a tamper-proof plastic tag, se- type ham processed in accordance with curely attached to the pork loin itself, paragraph (i)(1) of this section, bears a that states the identifying number of hot iron brand or an ink seal (with the the slaughtering establishment and the identifying number of the slaughtering date the pork loin was placed in the establishment) which was placed there- pickle preparation under the super- on at the slaughtering establishment vision of a person authorized to super- under the direct supervision of a person vise such activity by the veterinary authorized to supervise such activity service of the national government of by the veterinary services of the na- the region of origin. tional government of the region of ori- (k) The whole dry-cured ham, pork gin, bears a button seal (approved by shoulder, or pork loin came from an es- the Administrator, as being tamper- tablishment where a person authorized proof) on the hock that states the by the veterinary services of the na- month and year the ham entered the tional government of the region of ori- processing establishment and a hot gin to conduct activities under this iron brand (with the identifying num- paragraph, maintained original records ber of the processing establishment and (which shall be kept for a minimum of the date salting began) which were two years) identifying the dry-cured placed thereon at the processing estab- ham, pork shoulder, or pork loin by the

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date it entered the processing estab- (n) The whole dry-cured ham, pork lishment, by the slaughtering facility shoulder, or pork loin came from a from which it came, and by the number processing establishment that has en- of the certificate which accompanied tered into a cooperative service agree- the dry-cured ham, pork shoulder, or ment executed by the operator of the pork loin from the slaughtering facil- establishment or a representative of ity to the processing establishment, the establishment and APHIS, and that and where such original records are pursuant to the cooperative service maintained under lock and key by such agreement is current in paying all person, with access to such original costs for a veterinarian of APHIS to in- records restricted to officials of the spect the establishment (it is antici- government of the region of origin, of- pated that such inspections will occur ficials of the United States Govern- up to four times per year), including ment, and such person maintaining the travel, salary, subsistence, administra- records; tive overhead, and other incidental ex- (l) The whole dry-cured ham, pork penses (including an excess baggage shoulder, or pork loin came from a provision up to 150 pounds). In accord- processing establishment which allows ance with the terms of the cooperative the unannounced entry into the estab- service agreement, the operator of the lishment of APHIS personnel, or other processing establishment shall deposit persons authorized by the Adminis- with the Administrator, an amount trator, for the purpose of inspecting equal to the approximate costs for a the establishment and records of the veterinarian to inspect the establish- establishment; ment one time, including travel, sal- (m) The dry-cured ham, pork shoul- ary, subsistence, administrative over- der, or pork loin was processed in ac- head and other incidental expenses (in- cordance with one of the following cri- cluding an excess baggage provision up teria: (1) The ham, if it is an Italian- to 150 pounds), and as funds from that type ham processed in accordance with amount are obligated, bills for costs in- paragraph (i)(1) of this section, was curred based on official accounting processed in a region which has been records will be issued to restore the de- determined by the Administrator, to be posit to its original level. Amounts to free of rinderpest, and which has restore the deposit to its original level through its veterinary services sub- shall be paid within 14 days of receipt mitted to the Administrator, a written of such bills. statement stating that it conducts a (o) The dry-cured ham, pork shoul- program to authorize persons to super- der, or pork loin is accompanied at the vise activities specified under this sec- time of importation into the United tion; States by a certificate issued by a per- (2) The Serrano ham, processed in ac- son authorized to issue such certifi- cordance with paragraph (i)(2) of this cates by the veterinary services of the section, and came from any breed of national government of the region of large, white swine, including but not origin, stating: limited to Landrace, Pietrain, Duroc, (1) That all the provisions of this sec- Jersey, Hampshire, and Yorkshire tion have been complied with, includ- breeds, and crosses of such breeds; ing paragraphs (i) and (m) of this sec- (3) The Iberian ham, processed in action; cordance with paragraph (i)(3) of this (2) The paragraph of this section section, and came from a swine of the under which the dry-cured ham, pork Iberico breed of pigs; shoulder, or pork loin was processed; (4) The Iberian pork shoulder, proc- and stating further that, if the product essed in accordance with paragraph covered by the certificate: (i)(4) of this section, and came from a (i) Is an Italian-type ham processed swine of the Iberico breed of pigs; under paragraph (i)(1) of this section, it (5) The Iberian pork loin, if processed was processed for a minimum of 400 in accordance with paragraph (i)(5) of days; this section, and came from a swine of (ii) Is a Serrano ham processed under the Iberico breed of pigs. paragraph (i)(2) of this section, it was:

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(A) Processed for a minimum of 190 room, the room must have no direct ac- days in a region free of swine vesicular cess to areas in the facility where pork disease, in a facility authorized by the is cured and dried and it must be capa- veterinary services of the national gov- ble of being closed off from the rest of ernment of that region to process only the facility so unauthorized individuals meat from regions free of swine vesic- cannot enter. ular disease; or, (iii) The slicing/packaging facility, (B) Processed for a minimum of 560 including all equipment used to handle days in any region, in a facility that pork and pork products, such as con- may also process meat from regions tainers, work surfaces, slicing ma- where swine vesicular disease exists; chines, and packaging equipment, must (iii) Is an Iberian ham processed be cleaned and disinfected after sliced under paragraph (i)(3) of this section, it and packaged pork products that are was: not eligible for export to the United (A) Processed for a minimum of 365 States leave the facility, and before days in a region free of swine vesicular whole dry-cured hams, pork shoulders, disease, in a facility authorized by the or pork intended for importation into veterinary services of the national gov- the United States enter the facility for ernment of that region to process only slicing and packaging. Cleaning and meat from regions free of swine vesic- disinfecting must be adequate to en- ular disease; or, sure that disease agents of concern are (B) Processed for a minimum of 560 killed or inactivated and that pork days in any region, in a facility that products intended for importation into may also process meat from regions the United States are not contami- where swine vesicular disease exists; nated. (iv) Is a dry-cured pork shoulder, it (iv) The slicing/packaging facility was processed in accordance with para- must maintain under lock and key for graph (i)(4) of this section for a min- a minimum of 2 years, original records imum of 240 days; or on each lot of whole dry-cured hams, (v) Is a dry-cured pork loin, it was pork shoulders, and pork loins entering processed in accordance with para- the facility for slicing and packaging graph (i)(5) of this section for a min- under this section, including: imum of 130 days. (A) The approval number of the facil- (p) Whole hams, pork shoulders, and ity where the whole ham, shoulder, or pork loins that have been dry-cured in loin was dry-cured in accordance with accordance with paragraph (i) of this paragraph (i) of this section; section may be transported to a facil- (B) The date the whole ham, shoul- ity in the same region for slicing and der, or loin started dry-curing; packaging in accordance with this (C) The date the whole ham, shoul- paragraph. der, or loin completed dry-curing; (1) The slicing/packaging facility. (i) (D) The date the whole ham, shoul- The slicing/packaging facility 16 must der, or loin was sliced and packaged; be inspected, prior to slicing and pack- and aging any hams, pork shoulders, or (E) A copy of all certifications re- pork loins in accordance with this quired under paragraph (p) of this sec- paragraph, by an APHIS representative tion. and determined by the Administrator (v) Access to records required to be to be capable of meeting the provisions maintained under paragraph (p) of this of this paragraph. section must be restricted to officials (ii) The slicing/packaging facility of the national government of the re- must be either in a separate, physically gion of origin, representatives of the detached building, or in a separate United States Government, and per- room in the facility where the whole sons maintaining the records. ham, pork shoulder, or pork loin was (vi) The operator of the slicing/pack- dry-cured in accordance with para- aging facility must have signed a coop- graph (i) of this section. If the slicing/ erative service agreement with APHIS packaging facility is in a separate prior to receipt of the whole dry-cured hams, pork shoulders, or pork loins for 16 See footnote 15. slicing and packaging, stating that all

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hams, pork shoulders, or pork loins lot of dry-cured hams, pork shoulders, sliced and packaged at the facility for and pork loins at the slicing/packaging importation into the United States will facility; that each lot of dry-cured be sliced and packaged only in accord- hams, pork shoulders, and pork loins ance with this section. was sliced and packaged in accordance (vii) The operator of the slicing/pack- with the requirements of this para- aging facility must be current, in ac- graph; and that the sliced and pack- cordance with the terms of the cooper- aged pork ham, shoulder, or loin is the ative service agreement signed with same dry-cured ham, pork shoulder, or APHIS, in paying all costs for an pork loin certified under paragraph APHIS representative to inspect the (p)(2)(i). establishment, including travel, salary, (iii) The sliced and packaged dry- subsistence, administrative overhead, cured pork ham, pork shoulder, or pork and other incidental expenses. loin must be labeled with the date that (viii) The slicing/packaging facility processing of the meat under paragraph must allow the unannounced entry into (i) of this section began, and with the the establishment of APHIS represent- date the meat was sliced and packaged. atives, or other persons authorized by the Administrator, for the purpose of (Approved by the Office of Management and Budget under control number 0579–0015) inspecting the establishment and records of the establishment. [52 FR 11625, Apr. 10, 1987, as amended at 53 (ix) Workers at the slicing/packaging FR 48520, Dec. 1, 1988; 54 FR 7395, Feb. 21, facility who handle pork or pork prod- 1989, 59 FR 55024, Nov. 3, 1994; 59 FR 67134, ucts in the facility must shower and Dec. 29, 1994; 62 FR 46181, Sept. 2, 1997; 62 FR 56023, Oct. 28, 1997; 62 FR 61004, Nov. 14, 1997; put on a full set of clean clothes, or 64 FR 38550, July 19, 1999; 68 FR 16939, Apr. 7, wait 24 hours after handling pork or 2003; 73 FR 17885, Apr. 2, 2008; 74 FR 18288, pork products that are not eligible for Apr. 22, 2009; 76 FR 4054, 4055, Jan. 24, 2011; 77 importation into the United States, be- FR 1395, Jan. 10, 2012] fore handling dry-cured hams, pork shoulders, or pork loins in the slicing/ § 94.18 Restrictions on importation of packaging facility that are intended meat and edible products from for importation into the United States. ruminants due to bovine spongiform encephalopathy. (x) Pork products intended for importation into the United States may not (a)(1) Bovine spongiform be in the slicing/packaging facility at encephalopathy exists in the following the same time as pork products not in- regions: Austria, Belgium, the Czech tended for exportation to the United Republic, Denmark, Finland, France, States. Germany, Greece, the Republic of Ire- (2) Slicing and packaging and labeling land, Israel, Italy, Japan, Liech- procedures. (i) A full-time salaried vet- tenstein, Luxembourg, Oman, The erinarian employed by the national Netherlands, Poland, Portugal, Slo- government of the region of origin vakia, Slovenia, Spain, Switzerland, must inspect each lot of whole dry- and the United Kingdom. cured hams, pork shoulders, and pork (2) The following regions, because of loins at the slicing/packaging facility, import requirements less restrictive before slicing is begun, and must cer- than those that would be acceptable for tify in English that it is eligible for im- import into the United States and/or portation into the United States in ac- because of inadequate surveillance, cordance with this section; and present an undue risk of introducing (ii) Either a full-time salaried veteri- bovine spongiform encephalopathy into narian employed by the national gov- the United States: Albania, Andorra, ernment of the region of origin, or, if Bosnia-Herzegovina, Bulgaria, Croatia, the national government of the region the Federal Republic of Yugoslavia, of origin recognizes a local consortium Hungary, the Former Yugoslav Repub- as responsible for product quality, a lic of Macedonia, Monaco, Norway, Ro- representative of that local consor- mania, San Marino, and Sweden. tium, must certify in English that he (3) The following are minimal-risk or she personally supervised the entire regions with regard to bovine process of slicing and packaging each spongiform encephalopathy: Canada.

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(4) A region may request at any time the requirements of paragraphs (d)(1) that the Administrator consider its re- through (d)(5) of this section are met: moval from a list in paragraphs (a)(1) (1) The person moving the articles or (a)(2) of this section, or its addition must obtain a United States Veteri- to or removal from the list in para- nary Permit for Importation and graph (a)(3) of this section, by fol- Transportation of Controlled Materials lowing the procedures in part 92 of this and Organisms and Vectors by filing a subchapter. permit application on VS form 16–3. 18 (b) Except as provided in paragraph (2) The articles must be sealed in (d) of this section or in §§ 94.19 or 94.27, leakproof containers bearing serial the importation of meat, meat prod- numbers during transit. Each con- ucts, and edible products other than tainer must remain sealed during the meat (except for gelatin as provided in entire time that it is in the United paragraph (c) of this section, milk, and States. milk products) from ruminants that (3) The person moving the articles have been in any of the regions listed must notify, in writing, the inspector in paragraph (a) of this section is pro- at both the place in the United States hibited. where the articles will arrive and the (c) Gelatin. The importation of gela- port of export before such transit. The tin derived from ruminants that have notification must include the: been in any region listed in paragraph (i) United States Veterinary Permit (a) of this section is prohibited unless for Importation and Transportation of the following conditions or the condi- Controlled Materials and Organisms tions of § 94.19(f) have been met: and Vectors permit number; (1) The gelatin must be imported for (ii) Times and dates of arrival in the use in human food, human pharma- United States; ceutical products, photography, or (iii) Times and dates of exportation some other use that will not result in from the United States; the gelatin coming in contact with (iv) Mode of transportation; and ruminants in the United States. (v) Serial numbers of the sealed con- (2) The person importing the gelatin tainers. must obtain a United States Veteri- (4) The articles must transit the nary Permit for Importation and United States in Customs bond. Transportation of Controlled Materials (5) The commodities must be eligible and Organisms and Vectors by filing a to enter the United States in accord- permit application on VS form 16–3. 17 ance with § 94.19 and must be accom- (3) The permit application must state panied by the certification required by the intended use of the gelatin and the that section. Additionally, the fol- name and address of the consignee in lowing conditions must be met: the United States. (i) The shipment must be exported (d) Transit shipment of articles. Meat, from the United States within 7 days of meat products, and edible products its entry; other than meat that are prohibited (ii) The commodities may not be importation into the United States in transloaded while in the United States, accordance with this section may tran- except for direct transloading under sit air and ocean ports in the United the supervision of an authorized in- States for immediate export if the con- spector, who must break the seals of ditions of paragraph (d)(1) through the national government of the region (d)(4) of this section are met. If such of origin on the means of conveyance commodities are derived from bovines, that carried the commodities into the sheep, or goats from a region listed in United States and seal the means of paragraph (a)(3) of this section, they conveyance that will carry the com- are eligible to transit the United modities out of the United States with States by overland transportation if seals of the U.S. Government;

17 VS form 16–3 may be obtained from the 18 VS form 16–3 may be obtained from the Animal and Plant Health Inspection Service, Animal and Plant Health Inspection Service, Veterinary Services, National Center for Im- Veterinary Services, National Center for Im- port-Export, 4700 River Road Unit 38, River- port-Export, 4700 River Road Unit 38, River- dale, Maryland 20737–1231. dale, Maryland 20737–1231.

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(iii) A copy of the import permit re- CFR 589.2000 and meets the following quired under paragraph (d)(1) of this conditions: section must be presented to the in- (1) The meat, meat byproduct, or spector at the port of arrival and the meat food product is derived from bo- port of export in the United States. vines for which an air-injected stun- (Approved by the Office of Management and ning process was not used at slaughter; Budget under control number 0579–0015) and (2) The SRMs of the bovines were re- [56 FR 63868, Dec. 6, 1991] moved at slaughter. EDITORIAL NOTE: For FEDERAL REGISTER ci- (b) Whole or half carcasses of bovines. tations affecting § 94.18, see the List of CFR The carcasses are derived from bovines Sections Affected, which appears in the for which an air-injected stunning Finding Aids section of the printed volume and at www.fdsys.gov. process was not used at slaughter and that meet the following conditions: § 94.19 Restrictions on importation (1) The bovines are subject to a rumi- from BSE minimal-risk regions of nant feed ban equivalent to the re- meat and edible products from quirements established by the U.S. ruminants. Food and Drug Administration at 21 Except as provided in § 94.18 and this CFR 589.2000; and section, the importation of meat, meat (2) The SRMs of the bovines were re- products, and edible products other moved at slaughter. than meat (excluding gelatin that (c) Meat, meat byproducts, and meat meets the conditions of § 94.18(c), milk, food products from sheep or goats or other and milk products), from bovines, ovines or caprines. The meat, meat by- sheep, or goats that have been in any product, or meat food product, as de- of the regions listed in § 94.18(a)(3) is fined by FSIS in 9 CFR 301.2, is derived prohibited. The commodities listed in from ovines or caprines that are from a paragraphs (a) through (f) of this sec- flock or herd subject to a ruminant tion may be imported from a region feed ban equivalent to the require- listed in § 94.18(a)(3) if the conditions of ments established by the U.S. Food and this section are met; if (except for com- Drug Administration at 21 CFR modities described in paragraph (e) of 589.2000, that were less than 12 months this section) the commodities are ac- of age when slaughtered, and that meet companied by an original certificate of the following conditions: such compliance issued by a full-time (1) The animals were slaughtered at a salaried veterinary officer of the na- facility that either slaughters only tional government of the region of ori- sheep and/or goats or other ovines and gin, or issued by a veterinarian des- caprines less than 12 months of age or ignated or accredited by the national complies with a segregation process ap- government of the region of origin and proved by the national veterinary au- endorsed by a full-time salaried veteri- thority of the region of origin and the nary officer of the national govern- Administrator as adequate to prevent ment of the region of origin, rep- contamination or commingling of the resenting that the veterinarian issuing meat with products not eligible for im- the certificate was authorized to do so; portation into the United States; and if all other applicable require- (2) The animals did not test positive ments of this part are met. for and were not suspect for a trans- (a) Meat, meat byproducts, and meat missible spongiform encephalopathy; food products from bovines. The meat, (3) The animals have not resided in a meat byproduct, or meat food product, flock or herd that has been diagnosed as defined by FSIS in 9 CFR 301.2—that with BSE; and those terms as applied to bison shall (4) The animals’ movement is not re- have a meaning comparable to those stricted within Canada as a result of provided in 9 CFR 301.2 with respect to exposure to a transmissible spongiform cattle, sheep, and goats—is derived encephalopathy. from bovines that have been subject to (d) Carcasses of ovines and caprines. a ruminant feed ban equivalent to the The carcasses are derived from ovines requirements established by the U.S. or caprines that are from a flock or Food and Drug Administration at 21 herd subject to a ruminant feed ban

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equivalent to the requirements estab- (1) The bones of bovines subject to a lished by the U.S. Food and Drug Ad- ruminant feed ban equivalent to the re- ministration at 21 CFR 589.2000, that quirements established by the U.S. were less than 12 months of age when Food and Drug Administration at 21 slaughtered, and that meet the fol- CFR 589.2000 and from which SRMs lowing conditions: were removed, and the gelatin has not (1) The animals were slaughtered at a been commingled with materials ineli- facility that either slaughters only gible for entry into the United States; sheep and/or goats or other ovines and or caprines less than 12 months of age or (2) The hides of bovines, and the gela- complies with a segregation process ap- tin has not been commingled with ma- proved by the national veterinary au- terials ineligible for entry into the thority of the region of origin and the United States. Administrator as adequate to prevent (g) Ports. All products to be brought contamination or commingling of the into the United States under this sec- meat with products not eligible for im- tion must, if arriving at a land border portation into the United States; port, arrive at one of the following (2) The animals did not test positive ports: Eastport, ID; Houlton, ME; De- for and were not suspect for a trans- troit (Ambassador Bridge), Port Huron, missible spongiform encephalopathy; and Sault St. Marie, MI; International (3) The animals have not resided in a Falls, MN; Sweetgrass, MT; Alexandria flock or herd that has been diagnosed Bay, Buffalo (Lewiston Bridge and with BSE; and Peace Bridge), and Champlain, NY; (4) The animals’ movement is not re- Pembina and Portal, ND; Derby Line stricted within Canada as a result of and Highgate Springs, VT; and Blaine exposure to a transmissible spongiform (Pacific Highway and Cargo Ops), encephalopathy. Lynden, Oroville, and Sumas (Cargo), (e) Meat or dressed carcasses of hunter- WA. harvested wild sheep, goats, or other ruminants other than cervids. The meat [70 FR 550, Jan. 4, 2005, as amended at 70 FR 12113, Mar. 11, 2005; 72 FR 53378, Sept. 18, 2007; or dressed carcass (eviscerated and the 73 FR 3384, Jan. 18, 2008] head is removed) is derived from a wild sheep, goat, or other ruminant other § 94.20 Gelatin derived from horses or than a cervid and meets the following swine, or from ruminants that have conditions: not been in any region where bo- (1) The meat or dressed carcass is de- vine spongiform encephalopathy ex- rived from an animal that has been le- ists. gally harvested in the wild, as verified Gelatin derived from horses or swine, by proof such as a hunting license, tag, or from ruminants that have not been or the equivalent that the hunter must in any region listed in § 94.18(a) of this show to the United States Customs and part, must be accompanied at the time Border Protection official; and of importation into the United States (2) The animal from which the meat by an official certificate issued by a is derived was harvested within a juris- veterinarian employed by the national diction specified by the Administrator government of the region of origin. The for which the game and wildlife service official certificate must state the spe- of the jurisdiction has informed the cies of animal from which the gelatin Administrator either that the jurisdic- is derived and, if the gelatin is derived tion conducts no type of game feeding from ruminants, certify that the gela- program, or has complied with, and tin is not derived from ruminants that continues to comply with, a ruminant have been in any region listed in feed ban equivalent to the require- § 94.18(a). ments established by the U.S. Food and Drug Administration at 21 CFR (Approved by the Office of Management and 589.2000. Budget under control number 0579–0015) (f) Gelatin other than that allowed im- [58 FR 50251, Sept. 27, 1993, as amended at 59 portation under § 94.18(c). The gelatin is FR 67134, Dec. 29, 1994; 62 FR 56023, Oct. 28, derived from: 1997. Redesignated at 70 FR 550, Jan. 4, 2005]

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§ 94.21 [Reserved] cass still has not reached a pH of 5.8 or less after 60 hours, the meat from the § 94.22 Restrictions on importation of carcass may not be exported to the beef from Uruguay. United States. Notwithstanding any other provi- (j) An authorized veterinary official sions of this part, fresh (chilled or fro- of the Government of Uruguay certifies zen) beef from Uruguay may be ex- on the foreign meat inspection certifi- ported to the United States under the cate that the above conditions have following conditions: been met. (a) The meat is beef from bovines (k) The establishment in which the that have been born, raised, and bovines are slaughtered allows periodic slaughtered in Uruguay. on-site evaluation and subsequent in- (b) Foot-and-mouth disease has not spection of its facilities, records, and been diagnosed in Uruguay within the operations by an APHIS representa- previous 12 months. tive. (c) The beef came from bovines that [68 FR 31949, May 29, 2003. Redesignated at 70 originated from premises where foot- FR 550, Jan. 4, 2005] and-mouth disease has not been present during the lifetime of any bo- § 94.23 Importation of poultry meat vines slaughtered for the export of beef and other poultry products from to the United States. Sinaloa and Sonora, Mexico. (d) The beef came from bovines that Notwithstanding any other provi- were moved directly from the premises sions of this part, poultry meat and of origin to the slaughtering establish- other poultry products from the States ment without any contact with other of Sinaloa and Sonora, Mexico, may be animals. imported into the United States under (e) The beef came from bovines that the following conditions: received ante-mortem and post- (a) The poultry meat or other poultry mortem veterinary inspections, paying products are derived from poultry born particular attention to the head and and raised in Sinaloa or Sonora and feet, at the slaughtering establish- slaughtered in Sinaloa or Sonora at a ment, with no evidence found of vesic- federally inspected slaughter plant ular disease. under the direct supervision of a full- (f) The beef consists only of bovine time salaried veterinarian of the Gov- parts that are, by standard practice, ernment of Mexico, and the slaughter part of the animal’s carcass that is plant must be approved to export poul- placed in a chiller for maturation after try meat and other poultry products to slaughter. Bovine parts that may not the United States in accordance with 9 be imported include all parts of bovine CFR 381.196. heads, feet, hump, hooves, and internal (b) If processed, the poultry meat or organs. other poultry products were processed (g) All bone and visually identifiable in either Sinaloa or Sonora, Mexico, in blood clots and lymphoid tissue have a federally inspected processing plant been removed from the beef. that is under the direct supervision of (h) The beef has not been in contact a full-time salaried veterinarian of the with meat from regions other than Government of Mexico. those listed in § 94.1(a)(2). (c) The poultry meat or other poultry (i) The beef came from bovine car- products have not been in contact with casses that were allowed to maturate poultry from any State in Mexico other at 40 to 50 °F (4 to 10 °C) for a minimum than Sinaloa or Sonora or with poultry of 36 hours after slaughter and that from any other region not listed in reached a pH of 5.8 or less in the loin § 94.6 as a region where exotic New- muscle at the end of the maturation castle disease is not known to exist. period. Measurements for pH must be (d) The foreign meat inspection cer- taken at the middle of both longissimus tificate accompanying the poultry dorsi muscles. Any carcass in which the meat or other poultry products (re- pH does not reach 5.8 or less may be al- quired by 9 CFR 381.197) includes state- lowed to maturate an additional 24 ments certifying that the requirements hours and be retested, and, if the car- in paragraphs (a), (b), and (c) of this

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section have been met and, if applica- a region in which classical swine fever ble, listing the numbers of the seals re- is known to exist, except for the quired by paragraph (e)(1) of this sec- APHIS-defined European CSF region; tion. (ii) A restricted zone in the APHIS- (e) The shipment of poultry meat or defined European CSF region estab- other poultry products has not been in lished because of detection of classical any State in Mexico other than Sinaloa swine fever in domestic swine, from the or Sonora or in any other region not time of detection until the designation listed in § 94.6 as a region where exotic of the zone as a restricted zone is re- Newcastle disease is not known to moved by the competent veterinary au- exist, unless: thority or until 6 months following de- (1) The poultry meat or other poultry population of the swine on affected products arrive at the U.S. port of premises in the restricted zone and the entry in shipping containers bearing cleaning and disinfection of the last af- intact, serially numbered seals that fected premises in the zone, whichever were applied at the federally inspected is later; or slaughter plant by a full-time salaried (iii) A restricted zone in the APHIS- veterinarian of the Government of defined European CSF region estab- Mexico, and the seal numbers cor- lished because of the detection of clas- respond with the seal numbers listed sical swine fever in wild boar, from the on the foreign meat inspection certifi- time of detection until the designation cate; or of the zone as a restricted zone is re- (2) The poultry meat or other poultry moved by the competent veterinary au- products arrive at the U.S. port of thority. entry in shipping containers bearing (2) The pork and pork products must seals that have different numbers than not have been commingled with pork the seal numbers on the foreign meat or pork products derived from other inspection certificate, but, upon in- swine that were in any of the regions spection of the hold, compartment, or or zones described in paragraphs container and all accompanying docu- (a)(1)(i) through (a)(1)(iii) of this sec- mentation, an APHIS representative is tion, unless the other swine were satisfied that the poultry containers slaughtered after the periods described. were opened and resealed en route by Additionally, the pork and pork prod- an appropriate official of the Govern- ucts must not have been derived from ment of Mexico and the poultry meat swine that were commingled with or other poultry products were not con- other swine that were in any of the re- taminated or exposed to contamination gions or zones described in paragraphs during movement from Sinaloa or So- (a)(1)(i) through (a)(1)(iii) of this sec- nora to the United States. tion, unless the swine from which the [65 FR 15526, Mar. 23, 2000. Redesignated at 70 pork or pork products were derived FR 550, Jan. 4, 2005] were slaughtered after the periods described. § 94.24 Restrictions on the importation (3) The swine from which the pork or of pork, pork products, and swine pork products were derived must not from the APHIS-defined European have transited any region or zone de- CSF region. scribed in paragraphs (a)(1)(i) through (a) Pork and pork products. In addition (a)(1)(iii) of this section, unless the to meeting all other applicable provi- swine were moved directly through the sions of this part, fresh pork and pork region or zone in a sealed means of con- products imported from the APHIS-de- veyance with the seal determined to be fined European CSF region must meet intact upon arrival at the point of des- the following conditions: tination, or unless the swine were (1) The pork or pork products must slaughtered after the periods described. not have been derived from swine that (4) No equipment or materials used in were in any of the following regions or transporting the swine from which the zones, unless the swine were slaugh- pork or pork products were derived tered after the periods described: from the farm of origin to the slaugh- (i) Any region when the region was tering establishment may have been classified under §§ 94.9(a) and 94.10(a) as used previously for transporting swine

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that do not meet the requirements of tion, unless the swine are exported this section, unless the equipment and after the periods described. materials have first been cleaned and (4) The swine must not have disinfected. transited any region or zone described (5) The pork and pork products must in paragraphs (b)(2)(i) through be accompanied by a certificate issued (b)(2)(iii) of this section, unless the by an official of the competent veteri- swine were moved directly through the nary authority who is authorized to region or zone in a sealed means of con- issue the foreign meat inspection cer- veyance with the seal determined to be tificate required by § 327.4 of this title, intact upon arrival at the point of des- stating that the applicable provisions tination, or unless the swine are ex- of paragraphs (a)(1) through (a)(4) of ported after the periods described; 19 this section have been met. (5) No equipment or materials used in (b) Live swine. In addition to meeting transporting the swine may have been all other applicable provisions of this used previously for transporting swine title, live swine imported from the that do not meet the requirements of APHIS-defined European CSF region this section, unless the equipment and must meet the following conditions: (1) The swine must be breeding swine. materials have first been cleaned and (2) The swine must not have been in disinfected. any of the following regions or zones, (6) The swine must be accompanied unless the swine are exported to the by a certificate issued by a salaried United States after the periods de- veterinary officer of the competent scribed: veterinary authority, stating that the (i) Any region when the region was conditions of paragraphs (b)(1) through classified under §§ 94.9(a) and 94.10(a) as (b)(5) of this section have been met. 20 a region in which classical swine fever (c) The certificates required by para- is known to exist, except for the graphs (a)(5) and (b)(6) of this section APHIS-defined European CSF region; must be presented by the importer to (ii) A restricted zone in the APHIS- an authorized inspector at the port of defined European CSF region estab- arrival, upon arrival of the swine, pork, lished because of the detection of clas- or pork products at the port. sical swine fever in domestic swine, from the time of detection until the (Approved by the Office of Management and designation of the zone as a restricted Budget under control numbers 0579–0218 and 0579–0265) zone is removed by the competent veterinary authority or until 6 months [71 FR 29071, May 19, 2006. Redesignated at 71 following depopulation of the swine on FR 31070, June 1, 2006, as amended at 72 FR affected premises in the restricted zone 67232, Nov. 28, 2007; 74 FR 18288, Apr. 22, 2009; and the cleaning and disinfection of the 76 FR 4054, Jan. 24, 2011; 76 FR 70039, Nov. 10, 2011; 77 FR 1395, Jan. 10, 2012] last affected premises in the zone, whichever is later; or § 94.25 Restrictions on the importation (iii) A restricted zone in the APHIS- of live swine, pork, or pork prod- defined European CSF region estab- ucts from certain regions free of lished because of the detection of clas- classical swine fever. sical swine fever in wild boar, from the time of detection until the designation (a) Live swine, pork, or pork products of the zone as a restricted zone is re- and ship stores, airplane meals, and moved by the competent veterinary au- baggage containing pork or pork prod- thority. ucts, other than those articles regu- (3) The swine must not have been lated under part 95 or part 96 of this commingled with other swine that chapter, may not be imported into the have at any time been in any of the re- United States from a region listed gions or zones described in paragraphs under paragraph (a)(2) of this section (b)(2)(i) through (b)(2)(iii) of this sec- unless the requirements in this section,

19 The certification required may be placed 20 The certification required may be placed on the foreign meat inspection certificate re- on the certificate required by § 93.505(a) of quired by § 327.4 of this title or may be con- this chapter or may be contained in a sepa- tained in a separate document. rate document

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in addition to other applicable require- gion of export. Upon arrival of the ments of part 93 of this chapter and swine in the United States, the certifi- part 327 of this title, are met. cation must be presented to an author- (1) The regions listed under para- ized inspector at the port of arrival. graph (a)(2) of this section have been The certification must identify both declared free of classical swine fever the exporting region and the region of (CSF) by APHIS in accordance with origin as a region listed under §§ 94.9 §§ 94.9(a) and 94.10(a) but either supple- and 94.10 as free of CSF at the time the ment their pork supplies with fresh swine were in the region and must (chilled or frozen) pork imported from state that: regions considered to be affected by (1) The swine have not lived in a re- CSF, or supplement their pork supplies gion classified under §§ 94.9 and 94.10 as with pork from CSF-affected regions a region in which CSF is known to that is not processed in accordance exist; with the requirements of this part, or (2) The swine have never been com- share a common land border with CSF- mingled with swine that have been in a affected regions, or import live swine region that is classified under §§ 94.9 from CSF-affected regions under condi- and 94.10 as a region in which CSF is tions less restrictive than would be ac- known to exist; ceptable for importation into the (3) The swine have not transited a re- United States. Thus, the live swine, gion classified under §§ 94.9 and 94.10 as pork, or pork products from those re- a region in which CSF is known to gions may be commingled with live exist unless moved directly through swine, pork, or pork products from the region to their destination in a CSF-affected regions, resulting in a sealed means of conveyance with the risk of CSF introduction into the seal intact upon arrival at the point of United States. destination; and (2) A list of regions whose live swine, pork, and pork products are regulated (4) The conveyances or materials under this section is maintained on the used in transporting the swine, if pre- APHIS Web site at http:// viously used for transporting swine, www.aphis.usda.gov/importlexport/ani- have been cleaned and disinfected in mals/animalldiseaselstatus.shtml. Cop- accordance with the requirements of ies of the list will also be available via § 93.502 of this chapter. postal mail, fax, or email upon request (c) Pork or pork products. The pork or to the Sanitary Trade Issues Team, Na- pork products must be accompanied by tional Center for Import and Export, a certification issued by a full-time Veterinary Services, Animal and Plant salaried veterinary officer of the na- Health Inspection Service, 4700 River tional government of the region of ex- Road Unit 38, Riverdale, Maryland port. Upon arrival of the pork or pork 20737. products in the United States, the cer- (3) APHIS will add a region to the tification must be presented to an au- list of those whose live swine, pork, thorized inspector at the port of ar- and pork products are regulated under rival. The certification must identify this section after conducting an eval- both the exporting region and the re- uation of the region and determining gion of origin of the pork or pork prod- that one or more of the circumstances ucts as a region listed under §§ 94.9 and described in paragraph (a)(1) of this 94.10 as free of CSF at the time the section exists. APHIS will remove a re- pork or pork products were in the region from the list upon conducting an gion and must state that: evaluation of the region and deter- (1) The pork or pork products were mining that the circumstances in para- derived from swine that were born and graph (a)(1) of this section no longer raised in a region listed under §§ 94.9 exist or upon determining that clas- and 94.10 as free of CSF and were sical swine fever exists in the region. slaughtered in such a region at a feder- (b) Live swine. The swine must be ac- ally inspected slaughter plant that is companied by a certification issued by under the direct supervision of a full- a full-time salaried veterinary officer time salaried veterinarian of the na- of the national government of the re- tional government of that region and

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that is eligible to have its products im- clared such regions to be free of END, ported into the United States under live poultry originating in such free re- the Federal Meat Inspection Act (21 gions may be commingled with live U.S.C. 601 et seq.) and the regulations in poultry originating in an END-affected § 327.2 of this title; region and the meat and other animal (2) The pork or pork products were products produced in such free regions derived from swine that have not lived may be commingled with the fresh in a region classified under §§ 94.9 and (chilled or frozen) meat of animals 94.10 as a region in which CSF is known from an END-affected region, resulting to exist; in an undue risk of introducing END (3) The pork or pork products have into the United States. Therefore, live never been commingled with pork or poultry, poultry meat and other poul- pork products that have been in a re- try products, and ship stores, airplane gion that is classified under §§ 94.9 and meals, and baggage containing such 94.10 as a region in which CSF is known meat or animal products originating in to exist; the free regions listed in this section (4) The pork or pork products have may not be imported into the United not transited through a region classi- States unless the following require- fied under §§ 94.9 and 94.10 as a region in ments, in addition to all other applica- which CSF is known to exist unless ble requirements of part 93 of this moved directly through the region to chapter and of chapter III of this title, their destination in a sealed means of are met: conveyance with the seal intact upon (a) Additional certification. Live poul- arrival at the point of destination; and try, poultry meat, and other poultry (5) If processed, the pork or pork products from any region designated in products were processed in a region this section must be accompanied by listed under §§ 94.9 and 94.10 as free of an additional certification by a full- CSF in a federally inspected processing time salaried veterinary officer of the plant that is under the direct super- national Government of the exporting vision of a full-time salaried veterinary region. Upon arrival of the live poul- official of the national government of try, poultry meat, or other poultry that region. product in the United States, the cer- (Approved by the Office of Management and tification must be presented to an au- Budget under control numbers 0579–0230 and thorized inspector at the port of ar- 0579–0235) rival. (b) Live poultry. The certification ac- [71 FR 31070, June 1, 2006, as amended at 72 FR 30470, June 1, 2007; 76 FR 15211, Mar. 21, companying live poultry must identify 2011; 77 FR 1395, Jan. 10, 2012] the exporting region of the poultry as a region designated in § 94.6(a) as free of § 94.26 Restrictions on importation of END and highly pathogenic avian in- live poultry, poultry meat, and fluenza at the time the poultry were in other poultry products from speci- the region and must state that: fied regions. (1) The poultry have not been in con- Argentina and the Mexican States of tact with poultry or poultry products Campeche, Quintana Roo, and Yucatan, from any region where END is consid- which are declared in § 94.6(a)(1) to be ered to exist; free of exotic Newcastle disease (END), (2) The poultry have not lived in a re- supplement their meat supply by the gion where END is considered to exist; importation of fresh (chilled or frozen) and poultry meat from regions designated (3) The poultry have not transited in § 94.6(a) as regions where END is con- through a region where END is consid- sidered to exist, have a common land ered to exist unless moved directly border with regions where END is con- through the region in a sealed means of sidered to exist, or import live poultry conveyance with the seal intact upon from regions where END is considered arrival at the point of destination. to exist under conditions less restric- (c) Poultry meat or other poultry prod- tive than would be acceptable for im- ucts. The certification accompanying portation into the United States. Thus, poultry meat or other poultry products even though the Department has de- must state that:

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(1) The poultry meat or other poultry chapter III), including the require- products are derived from poultry that ments for removal of SRMs and the meet all requirements of this section prohibition on the use of air-injection and that have been slaughtered in a re- stunning devices prior to slaughter on gion designated in § 94.6(a) as free of cattle from which the beef is derived. END and highly pathogenic avian in- (b) The beef is derived from cattle fluenza at a federally inspected slaugh- that were not subjected to a pithing ter plant that is under the direct super- process at slaughter. vision of a full-time salaried veteri- (c) An authorized veterinary official narian of the national Government of of the Government of Japan certifies the exporting region and that is ap- on an original certificate that the proved to export poultry meat and above conditions have been met. other poultry products to the United States in accordance with § 381.196 of [70 FR 73918, Dec. 14, 2005, as amended at 75 FR 65432, Oct. 25, 2010] this title; (2) The poultry meat or other poultry products have not been in contact with PART 95—SANITARY CONTROL OF poultry meat or other poultry products ANIMAL BYPRODUCTS (EXCEPT from any region where END is consid- CASINGS), AND HAY AND ered to exist; STRAW, OFFERED FOR ENTRY (3) The poultry meat or other poultry INTO THE UNITED STATES products have not transited through a region where END is considered to Sec. exist unless moved directly through 95.1 Definitions. the region in a sealed means of convey- 95.2 Region of origin. ance with the seal intact upon arrival 95.3 Byproducts from diseased animals pro- at the point of destination; and hibited. (4) If processed, the poultry meat or 95.4 Restrictions on the importation of processed animal protein, offal, tankage, other poultry products were processed fat, glands, certain tallow other than tal- in a region designated in § 94.6(a) as low derivatives, and blood and blood free of END and highly pathogenic products due to bovine spongiform avian influenza in a federally inspected encephalopathy. processing plant that is under the di- 95.5 Untanned hides and skins and bird tro- rect supervision of a full-time salaried phies; requirements for entry. veterinarian of the national Govern- 95.6 Untanned hides, skins, and bird tro- ment of the exporting region. phies; importations permitted subject to restrictions. (Approved by the Office of Management and 95.7 Wool, hair, and bristles; requirements Budget under control number 0579–0228) for unrestricted entry. 95.8 Wool, hair, and bristles; importations [69 FR 3823, Jan. 27, 2004. Redesignated at 70 permitted subject to restrictions. FR 550, Jan. 4, 2005, as amended at 71 FR 4813, 95.9 Glue stock; requirements for unre- Jan. 30, 2006; 76 FR 4055, Jan. 24, 2011] stricted entry. 95.10 Glue stock; importations permitted § 94.27 Importation of whole cuts of subject to restrictions. boneless beef from Japan. 95.11 Bones, horns, and hoofs for trophies or Notwithstanding the provisions of museums; disinfected hoofs. § 94.18, whole cuts of boneless beef de- 95.12 Bones, horns, and hoofs; importations rived from cattle that were born, permitted subject to restrictions. 95.13 Bone meal for use as fertilizer or as raised, and slaughtered in Japan may feed for domestic animals; requirements be imported into the United States for entry. under the following conditions: 95.14 Blood meal, tankage, meat meal, and (a) The beef is prepared in an estab- similar products, for use as fertilizer or lishment that is eligible to have its animal feed; requirements for entry. products imported into the United 95.15 Blood meal, blood albumin, intestines, States under the Federal Meat Inspec- and other animal byproducts for indus- tion Act (21 U.S.C. 601 et seq.) and the trial use; requirements for unrestricted entry. regulations in 9 CFR 327.2 and the beef 95.16 Blood meal, blood albumin, intestines, meets all other applicable require- and other animal byproducts for indus- ments of the Federal Meat Inspection trial use; importations permitted subject Act and regulations thereunder (9 CFR to restrictions.

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95.17 Glands, organs, ox gall, and like mate- tagions of foot-and-mouth disease and rials; requirements for unrestricted rinderpest. entry. 95.18 Glands, organs, ox gall, and like mate- Approved establishment means an es- rials; importations permitted subject to tablishment approved by Veterinary restrictions. Services for the receipt and handling of 95.19 Animal stomachs. restricted import animal byproducts. 95.20 Animal manure. Approved sewerage system means a 95.21 Hay and straw; requirements for unre- drainage system equipped and operated stricted entry. 95.22 Hay and straw; importations per- so as to carry and dispose of sewage mitted subject to restrictions. without endangering livestock through 95.23 Previously used meat covers; importa- the contamination of streams or fields tions permitted subject to restrictions. and approved by the Veterinary Serv- 95.24 Methods for disinfection of hides, ices. skins, and other materials. 95.25 Transportation of restricted import Approved warehouse means a ware- products; placarding cars and marking house having facilities approved by billing; unloading enroute. Veterinary Services for the handling 95.26 Railroad cars, trucks, boats, aircraft and storage, apart from other merchan- and other means of conveyance, equip- dise, of restricted import products. ment or containers, yards, and premises; Bird trophy. A carcass or part of a cleaning and disinfection. 95.27 Regulations applicable to products carcass of a wild bird taken as game from Territorial possessions. during a hunting expedition for the 95.28 Hay or straw and similar material purpose of processing into taxidermy from tick-infested areas. mounts for personal exhibition. 95.29 Certification for certain materials. Blood meal means dried blood of ani- 95.30 Restrictions on entry of products and byproducts of poultry, game birds, or mals. other birds from regions where highly Bone meal means ground animal pathogenic avian influenza (HPAI) exists. bones and hoof meal and horn meal. AUTHORITY: 7 U.S.C. 8301–8317; 21 U.S.C. 136 Bovine. Bos taurus, Bos indicus, and and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and Bison bison. 371.4. Bovine spongiform encephalopathy SOURCE: 28 FR 5981, June 13, 1963, unless (BSE) minimal-risk region. A region list- otherwise noted. ed in § 94.18(a)(3) of this subchapter. Department means the United States § 95.1 Definitions. Department of Agriculture. Whenever in the regulations in this Deputy Administrator of Veterinary part the following words, names, or Services means the Deputy Adminis- terms are used they shall be construed, trator of Veterinary Services. respectively, to mean: Direct transloading. The transfer of Administrator means the Adminis- cargo directly from one means of con- trator, Animal and Plant Health In- veyance to another. spection Service, or any individual au- Glue stock means fleshings, hide thorized to act for the Administrator. cuttings and parings, tendons, or other Animal and Plant Health Inspection collagenous parts of animal carcasses. Service (APHIS) means the Animal and Plant Health Inspection Service of the Hay and straw means dried grasses, United States Department of Agri- clovers, legumes, and similar materials culture. or stalks or stems of various grains, Animal byproducts means hides, skins, such as barley, oats, rice, rye, and hair, wool, glue stock, bones, hoofs, wheat. horns, bone meal, hoof meal, horn Inspector. Any individual authorized meal, blood meal, meat meal, tankage, by the Administrator of APHIS or the glands, organs, or other parts or prod- Commissioner of Customs and Border ucts of ruminants and swine unsuitable Protection, Department of Homeland for human consumption. Security, to enforce the regulations in Approved chlorinating equipment this part. means equipment approved by Veteri- Meat meal or tankage means the ren- nary Services as efficient for the dis- dered and dried carcasses or parts of infection of effluents against the con- the carcasses of animals.

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Offal. The inedible parts of a butch- and sudden movement; tremor, ‘‘star ered animal that are removed in dress- gazing,’’ head pressing, recumbency, or ing, consisting largely of the viscera other signs of neurological disease or and the trimmings, which may include, chronic wasting. but are not limited to, brains, thymus, United States means the several pancreas, liver, heart, kidney. States, the District of Columbia, Positive for a transmissible spongiform Guam, the Northern Mariana Islands, encephalopathy. A sheep or goat for Puerto Rico, the Virgin Islands of the which a diagnosis of a transmissible United States, and all other territories spongiform encephalopathy has been and possessions of the United States. made. Veterinary Services means the Veteri- Processed animal protein means meat nary Services unit of the Animal and meal, bone meal, meat and bone meal, Plant Health Inspection Service, blood meal, dried plasma and other United States Department of Agri- blood products, hydrolyzed proteins, culture. hoof meal, horn meal, poultry meal, feather meal, fish meal, and any other [28 FR 5981, June 13, 1963, as amended at 56 similar products. FR 19796, Apr. 30, 1991; 56 FR 63869, Dec. 6, Region. Any defined geographic land 1991; 62 FR 56024, Oct. 28, 1997; 66 FR 42600, Aug. 14, 2001; 70 FR 551, Jan. 4, 2005; 70 FR area identifiable by geological, polit- 71218, Nov. 28, 2005; 74 FR 66226, Dec. 15, 2009] ical, or surveyed boundaries. A region may consist of any of the following: § 95.2 Region of origin. (1) A national entity (country); (2) Part of a national entity (zone, No products or materials specified in county, department, municipality, par- the regulations in this part shall be im- ish, Province, State, etc.) ported unless there be shown upon the (3) Parts of several national entities commercial invoice, or in some other combined into an area; or manner satisfactory to the Deputy Ad- (4) A group of national entities (coun- ministrator, Veterinary Services, the tries) combined into a single area. name of the region of origin of such Specified risk materials (SRMs). Those product or material: Provided, That the bovine parts considered to be at par- region of origin shall be construed to ticular risk of containing the bovine mean (a) in the case of an animal by- spongiform encephalopathy (BSE) product, the region in which such prod- agent in infected animals, as listed in uct was taken from an animal or ani- the FSIS regulations at 9 CFR 310.22(a). mals, and (b) in the case of other mate- Suspect for a transmissible spongiform rials, the region in which such mate- encephalopathy. (1) A sheep or goat that rials were produced. has tested positive for a transmissible [28 FR 5981, June 13, 1963, as amended at 62 spongiform encephalopathy or for the FR 56024, Oct. 28, 1997] proteinase resistant protein associated with a transmissible spongiform § 95.3 Byproducts from diseased ani- encephalopathy, unless the animal is mals prohibited. designated as positive for a trans- The importation of any animal by- missible spongiform encephalopathy; product taken or removed from an ani- or mal affected with anthrax, foot-and- (2) A sheep or goat that exhibits any mouth disease, or rinderpest is prohib- of the following signs and that has ited. been determined to be suspicious for a transmissible spongiform § 95.4 Restrictions on the importation encephalopathy by a veterinarian: of processed animal protein, offal, Weight loss despite retention of appe- tankage, fat, glands, certain tallow tite; behavior abnormalities; pruritus other than tallow derivatives, and (itching); wool pulling; biting at legs or blood and blood products due to bo- side; lip smacking; motor abnormali- vine spongiform encephalopathy. ties such as incoordination, high step- (a) Except as provided in paragraphs ping gait of forelimbs, bunny hop (c) through (i) of this section, the im- movement of rear legs, or swaying of portation of the following is prohib- back end; increased sensitivity to noise ited:

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(1) Any of the materials listed in be imported for scientific, educational, paragraphs (a)(1)(i) through (a)(1)(iv) of or research purposes if the Adminis- this section that have been derived trator determines that the importation from animals that have been in any re- can be made under conditions that will gion listed in § 94.18(a) of this chapter: prevent the introduction of bovine (i) Processed animal protein, tank- spongiform encephalopathy into the age, offal, and tallow other than tallow United States. Serum from ruminants derivatives, unless, in the opinion of imported in accordance with this para- the Administrator, the tallow cannot graph must be accompanied by a per- be used in feed, regardless of the ani- mit issued by APHIS in accordance mal species from which the material with § 104.4 of this chapter, and must be was derived; moved and handled as specified on the (ii) Glands, unprocessed fat tissue, permit. and blood and blood products derived (c) Materials that are otherwise pro- from ruminants; hibited importation into the United (iii) Processed fats and oils, and de- States under paragraph (a) of this sec- rivatives of processed animal protein, tion may be imported into the United tankage, and offal, regardless of the States if the following conditions are animal species from which the mate- met prior to importation: rial was derived; and (1) The material is derived from a (iv) Derivatives of glands and blood nonruminant species, or from a rumi- and blood products derived from nant species if the ruminants have ruminants. never been in any region listed in (2) Any of the materials listed in § 94.18(a) of this chapter. paragraphs (a)(2)(i) through (a)(2)(iv) of (2) In regions listed in § 94.18(a)(1) or this section that have been stored, ren- (a)(2) of this subchapter as regions in dered, or otherwise processed in a re- which BSE exists or that present an gion listed in § 94.18(a) of this chapter, undue risk of introducing BSE into the or that have otherwise been associated United States, all steps of processing with a facility in a region listed in and storing the material are carried § 94.18(a) of this chapter or with any out in a facility that has not been used material listed in paragraph (a)(1) for the processing and storage of mate- through (a)(3) of this section: rials derived from ruminants that have (i) Processed animal protein, tank- been in any region listed in § 94.18(a) of age, offal, and tallow other than tallow this subchapter. derivatives, unless, in the opinion of (3) In regions listed in § 94.18(a)(3) of the Administrator, the tallow cannot this subchapter as BSE minimal-risk be used in feed, regardless of the ani- regions, all steps of processing and mal species from which the material storing the material are carried out in was derived; a facility that has not been used for (ii) Glands and unprocessed fat tissue the processing and storage of materials derived from ruminants; derived from ruminants that have been (iii) Processed fats and oils, and de- in any region listed in § 94.18(a)(1) or rivatives of processed animal protein, (a)(2) of this subchapter as a region in tankage, and offal, regardless of the which BSE exists or a region that pre- animal species from which the mate- sents an undue risk of introducing BSE rial was derived; and into the United States. (iv) Derivatives of glands from (4) The facility demonstrates to ruminants. APHIS that the materials intended for (3) Products containing any of the exportation to the United States were items prohibited importation under transported to and from the facility in paragraphs (a)(1) and (a)(2) of this sec- a manner that would prevent cross- tion. contamination by or commingling with (b) Except as provided in paragraphs prohibited materials. (d), (e), and (i) of this section, the im- (5) Except for facilities in regions portation of serum from ruminants listed in § 94.18(a)(3) of this subchapter, that have been in any region listed in if the facility processes or handles any § 94.18(a) of this chapter is prohibited, material derived from mammals, the except that serum from ruminants may facility has entered into a cooperative

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service agreement executed by the op- Riverdale, MD 20737–1231, or electroni- erator of the facility and APHIS. In ac- cally at http://www.aphis.usda.gov/ncie.) cordance with the cooperative service (d) Except as provided in paragraph agreement, the facility must be cur- (e) of this section, the importation of rent in paying all costs for a veteri- serum albumin, serocolostrum, narian of APHIS to inspect the facility amniotic liquids or extracts, and pla- (it is anticipated that such inspections cental liquids derived from ruminants will occur approximately once per that have been in any region listed in year), including travel, salary, subsist- § 94.18(a) of this chapter, and collagen ence, administrative overhead, and and collagen products that meet any of other incidental expenses (including the conditions listed in paragraphs excess baggage provisions up to 150 (a)(1) through (a)(3) of this section, is pounds). In addition, the facility must prohibited unless the following condi- have on deposit with APHIS an unobli- tions have been met: gated amount equal to the cost for (1) The article is imported for use as APHIS personnel to conduct one in- an ingredient in cosmetics; spection. As funds from that amount (2) The person importing the article are obligated, a bill for costs incurred has obtained a United States Veteri- based on official accounting records nary Permit for Importation and will be issued to restore the deposit to Transportation of Controlled Materials the original level, revised as necessary and Organisms and Vectors by filing a to allow for inflation or other changes permit application on VS form 16–3 (VS in estimated costs. To be current, bills Form 16–3 may be obtained from must be paid within 14 days of receipt. APHIS, Veterinary Services, National In facilities in regions listed in Center for Import-Export, 4700 River § 94.18(a)(3) of this subchapter, the in- Road Unit 38, Riverdale, MD 20737–1231, spections that would otherwise be con- or electronically at http:// ducted by APHIS must be conducted at www.aphis.usda.gov/ncie.); and least annually by a representative of (3) The permit application states the the government agency responsible for intended use of the article and the animal health in the region. name and address of the consignee in (6) The facility allows periodic the United States. APHIS inspection of its facilities, (e) Bovine blood and blood products records, and operations. that are otherwise prohibited importa- (7) Each shipment to the United tion under paragraph (a)(1) or (d) of States is accompanied by an original this section may be imported into the certificate signed by a full-time, sala- United States if they meet the fol- ried veterinarian of the government lowing conditions: agency responsible for animal health in (1) For blood collected at slaughter the region of export certifying that the and for products derived from blood conditions of paragraphs (c)(1) through collected at slaughter: (c)(4) of this section have been met; ex- (i) The blood was collected in a cept that, for shipments of animal feed closed system in which the blood was from a region listed in § 94.18(a)(3) of conveyed directly from the animal in a this subchapter, the certificate may be closed conduit to a closed receptacle, signed by a person authorized to issue or was collected otherwise in a hygien- such certificates by the veterinary ic manner that prevents contamination services of the national government of of the blood with SRMs. the region of origin. (ii) The slaughtered animal passed (8) The person importing the ship- ante-mortem inspection and was not ment has applied for and obtained from subjected to a pithing process or to a APHIS a United States Veterinary Per- stunning process with a device inject- mit for Importation and Transpor- ing compressed air or gas into the cra- tation of Controlled Materials and Or- nial cavity; ganisms and Vectors by filing a permit (2) For fetal bovine serum: application on VS form 16–3. (VS Form (i) The blood from which the fetal bo- 16–3 may be obtained from APHIS, Vet- vine serum was derived was collected erinary Services, National Center for in a closed system in which the blood Import-Export, 4700 River Road Unit 38, was conveyed directly from the animal

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in a closed conduit to a closed recep- Center for Import-Export, 4700 River tacle, or was collected otherwise in a Road Unit 38, Riverdale, MD 20737–1231, hygienic manner that prevents con- or electronically at http:// tamination of the blood with SRMs; www.aphis.usda.gov/ncie. (ii) The dam of the fetal calf passed NOTE TO PARAGRAPH (f): Insulin that is not ante-mortem inspection and was not prohibited from importation under this para- subjected to a pithing process or to a graph may be prohibited from importation stunning process with a device inject- under other Federal laws, including the Fed- ing compressed air or gas into the cra- eral Food, Drug, and Cosmetic Act, 21 U.S.C, nial cavity; 321 et seq.) (iii) The uterus was removed from (g) Tallow otherwise prohibited im- the dam’s abdominal cavity intact and portation under paragraph (a)(1) of this taken to a separate area sufficiently section may be imported into the removed from the slaughtering area of United States if it meets the following the facility to ensure that the fetal conditions: blood was not contaminated with (1) The tallow is derived from bovines SRMs when collected. that have not been in a region listed in (3) For blood collected from live § 94.18(a)(1) or (a)(2) of this subchapter; donor bovines and for products derived from blood collected from live donor (2) The tallow is composed of a max- bovines: imum level of insoluble impurities of (i) The blood was collected in a 0.15 percent in weight; closed system in which the blood was (3) After processing, the tallow was conveyed directly from the animal in a not exposed to or commingled with any closed conduit to a closed receptacle, other animal origin material; and or was collected otherwise in a hygien- (4) Each shipment to the United ic manner that prevents contamination States is accompanied by an original of the blood with SRMs; certificate signed by a full-time sala- (ii) The donor animal was free of ried veterinary officer of the national clinical signs of disease. government of the region of origin, or (4) Each shipment to the United issued by a veterinarian designated by States is accompanied by an original or accredited by the national govern- certificate signed by a full-time sala- ment of the region of origin and en- ried veterinary officer of the national dorsed by a full-time salaried veteri- government of the region of origin, or nary officer of the national govern- issued by a veterinarian designated by ment of the region of origin, rep- or accredited by the national govern- resenting that the veterinarian issuing ment of the region of origin, rep- the certificate was authorized to do so. resenting that the veterinarian issuing The certificate must state that the re- the certificate was authorized to do so. quirements of paragraphs (f)(1) through The certificate must state that the re- (f)(3) of this section have been met; and quirements of paragraph (e)(1), (e)(2), (5) The shipment, if arriving at a U.S. or (e)(3) of this section, as applicable, land border port, arrives at a port list- have been met. ed in § 94.19(g) of this subchapter. (f) Insulin otherwise prohibited from (h) Offal that is otherwise prohibited importation into the United States importation under paragraph (a)(1) of under paragraph (a) of this section is this section may be imported if the not prohibited from importation under offal is derived from cervids or the that paragraph if the insulin is for the offal is derived from bovines, ovines, or personal medical use of the person im- caprines from a region listed in porting it and if the person importing § 94.18(a)(3) of this subchapter that have the shipment has applied for and ob- not been in a region listed in tained from APHIS a United States § 94.18(a)(1) or (a)(2) of this subchapter, Veterinary Permit for Importation and and the following conditions are met: Transportation of Controlled Materials (1) If the offal is derived from bo- and Organisms and Vectors by filing a vines, the offal: permit application on VS form 16–3. (i) Contains no SRMs and is derived (VS Form 16–3 may be obtained from from bovines from which the SRMs APHIS, Veterinary Services, National were removed;

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(ii) Is derived from bovines for which of this subchapter, they are eligible to an air-injected stunning process was transit the United States by overland not used at slaughter; and transportation if the requirements of (iii) Is derived from bovines that are paragraphs (i)(1) through (i)(4) of this subject to a ruminant feed ban equiva- section are met: lent to the requirements established by (1) The person moving the articles the U.S. Food and Drug Administration has obtained from APHIS a United at 21 CFR 589.2000; States Veterinary Permit for Importa- (2) If the offal is derived from ovines tion and Transportation of Controlled or caprines, the offal: Materials and Organisms and Vectors (i) Is derived from ovines or caprines by filing a permit application on VS that were less than 12 months of age form 16–3. (VS Form 16–3 may be ob- when slaughtered and that are from a tained from APHIS, Veterinary Serv- flock or herd subject to a ruminant ices, National Center for Import-Ex- feed ban equivalent to the require- port, 4700 River Road Unit 38, River- ments established by the U.S. Food and dale, MD 20737–1231, or electronically at Drug Administration at 21 CFR http://www.aphis.usda.gov/ncie.) 589.2000; (2) The articles are sealed in leak- (ii) Is not derived from ovines or proof containers bearing serial num- caprines that have tested positive for bers during transit. Each container re- or are suspect for a transmissible mains sealed during the entire time spongiform encephalopathy; that it is in the United States. (iii) Is not derived from animals that (3) The person moving the articles have resided in a flock or herd that has notifies, in writing, the inspector at been diagnosed with BSE; and both the place in the United States (iv) Is derived from ovines or where the articles will arrive and the caprines whose movement was not report of export before such transit. The stricted in the BSE minimal-risk re- notification includes the following: gion as a result of exposure to a trans- (i) United States Veterinary Permit missible spongiform encephalopathy. for Importation and Transportation of (3) Each shipment to the United Controlled Materials and Organisms States is accompanied by an original and Vectors permit number; certificate signed by a full-time sala- (ii) Times and dates of arrival in the ried veterinary officer of the national United States; government of the region of origin, or issued by a veterinarian designated by (iii) Times and dates of exportation or accredited by the national govern- from the United States; ment of the region of origin and en- (iv) Mode of transportation; and dorsed by a full-time salaried veteri- (v) Serial numbers of the sealed con- nary officer of the national govern- tainers. ment of the region of origin, rep- (4) The articles are eligible to enter resenting that the veterinarian issuing the United States in accordance with the certificate was authorized to do so. this section and are accompanied by The certificate must state that the re- the certification required by this sec- quirements of paragraph (g)(1) or (g)(2) tion. Additionally, the following condi- of this section have been met; and tions must be met: (4) The shipment, if arriving at a U.S. (i) The shipment is exported from the land border port, arrives at a port list- United States within 7 days of its ed in § 94.19(g) of this subchapter. entry; (i) Transit shipment of articles. Arti- (ii) The commodities are not cles that are prohibited importation transloaded while in the United States, into the United States in accordance except for direct transloading under with this section may transit air and the supervision of an inspector, who ocean ports in the United States for must break the seals of the national immediate export if the conditions of government of the region of origin on paragraphs (i)(1) through (i)(3) of this the means of conveyance that carried section are met. If such commodities the commodities into the United are derived from bovines, sheep, or States and seal the means of convey- goats from a region listed in§ 94.18(a)(3) ance that will carry the commodities

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out of the United States with seals of toir in which is maintained an inspec- the U.S. Government; tion service that meets the require- (iii) A copy of the import permit re- ments and has been approved pursuant quired under paragraph (i)(1) of this to part 327 of this title; and section is presented to the inspector at (ii) The hides or skins are accom- the port of arrival and the port of ex- panied by a certificate bearing the seal port in the United States. of the proper department of that na- (Approved by the Office of Management and tional government and signed by an of- Budget under control numbers 0579–0015 and ficial veterinary inspector of the re- 0579–0183) gion in which the ruminants were slaughtered. The certificate must state [66 FR 42600, Aug. 14, 2001, as amended at 70 FR 552, Jan. 4, 2005; 70 FR 12113, Mar. 11, 2005; that the hides or skins were taken 70 FR 71218, Nov. 28, 2005; 71 FR 12998, Mar. from ruminants slaughtered in an abat- 14, 2006; 72 FR 53378, Sept. 18, 2007; 73 FR 3384, toir that meets the requirements of Jan. 18, 2008] paragraph (a)(3)(i) of this section and that the hides or skins are free from § 95.5 Untanned hides and skins and anthrax, foot-and-mouth disease, and bird trophies; requirements for rinderpest. entry. (4) Untanned ruminant hides or skins Untanned hides and skins and bird from any region may be imported with- trophies 1 may be imported into the out other restriction if an inspector de- United States if they meet the require- termines, based on inspection and upon ments of this section. Except for rumi- examination of a shipper or importer nant hides or skins from Mexico, certificate, that they have been pickled untanned hides and skins and bird tro- in a solution of salt containing mineral phies may also be imported if handled acid and packed in barrels, casks, or at an approved establishment as set tight cases while still wet with such so- forth in § 95.6. lution. The solution must be deter- (a) Untanned hides and skins. (1) Ex- mined by the inspector to have a pH of cept for ruminant hides or skins from less than or equal to 5. Mexico, any untanned hides or skins of (5) Untanned ruminant hides or skins ruminants from regions free of foot- from any region may be imported with- and-mouth disease and rinderpest and out other restriction if an inspector de- any untanned hides or skins of swine termines, based on inspection and upon from regions free of foot-and-mouth examination of a shipper or importer disease, rinderpest, and African swine certificate, that they have been treated fever may be imported without further with lime in such manner and for such restriction. period as to have obviously been proc- (2) Untanned ruminant hides or skins essed, to have become dehaired, and to may be imported from any region with- have reached the stage of preparation out other restriction if an inspector de- for immediate manufacture into prod- termines, based on inspection and upon ucts ordinarily made from rawhide. examination of a shipper or importer (b) Ruminant hides and skins from certificate, that they are hard dried hides or skins. Mexico. Ruminant hides and skins from (3) Except for ruminant hides or Mexico may enter the United States skins from Mexico, untanned abattoir without other restriction if: hides or skins of ruminants may be im- (1) They are free of ticks and have ported from any region without other been subjected to any one of the treat- restriction if the following requirements specified in paragraphs (a)(2), ments are met: (a)(4), or (a)(5) of this section; or (i) The ruminants from which the (2) They are inspected and found to hides or skins were taken have been have been frozen solid for 24 hours by slaughtered under national government an inspector and are accompanied by a inspection in a region2 and in an abat- certificate attesting to that fact issued

1 The importation of bird trophies is also Inspection Service, Veterinary Services, Na- subject to restrictions under § 95.30. tional Center for Import and Export, 4700 2 Names of these regions will be furnished River Road Unit 38, Riverdale, Maryland upon request to the Animal and Plant Health 20737-1231.

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by the shipper or importer that is re- customs seals from a coast or border viewed by the inspector, and are free port of arrival, with the approval of an from ticks; or inspector at said port, to another port (3) They are free from ticks and are in the United States for consumption accompanied by a certificate issued by entry subject to the other provisions of a full-time salaried veterinary officer this section. of the Government of Mexico stating (b) They shall be moved from the that they have been treated with an coast or border port of arrival or, in acaricide; or case of I. T. or in-bound shipments, (4) They are bovine hides taken from from the interior port to the approved cattle that were subjected to a ticki- establishment in cars or trucks or in cidal dip in one of the permitted dips vessel compartments with no other ma- listed in § 72.13(b) of this chapter at a terials contained therein, sealed with Mexican facility 7 to 12 days prior to seals of the Department, which shall slaughter, and are free from ticks. not be broken except by inspectors or (c) Bird trophies. Bird trophies from other persons authorized by the Deputy regions designated in § 94.6 of this sub- Administrator, Veterinary Services so chapter as free of exotic Newcastle dis- to do, or without sealing as aforesaid ease and free of HPAI subtype H5N1 and with other freight when packed in may be imported without further re- tight cases or casks acceptable to the striction if accompanied by a certifi- inspector in charge at the port of cate of origin issued by the national entry. government of the region of export. (c) They shall be handled at the ap- (Approved by the Office of Management and proved establishment under the direc- Budget under control numbers 0579–0015 and tion of an inspector in a manner ap- 0579–0307) proved by the Deputy Administrator, [74 FR 66226, Dec. 15, 2009, as amended at 76 Veterinary Services to guard against FR 28887, May 19, 2011] the dissemination of foot-and-mouth disease, rinderpest, African swine § 95.6 Untanned hides, skins, and bird fever, and exotic Newcastle disease. trophies; importations permitted They shall not be removed therefrom subject to restrictions. except upon special permission of the Except for ruminant hides or skins Deputy Administrator, Veterinary from Mexico, hides or skins or bird tro- Services and upon compliance with all phies offered for importation which do the conditions and requirements of this not meet the conditions or require- section relative to the movement of ments of § 95.5 shall be handled and the said hides and skins or bird tro- treated in the following manner after phies from the port of arrival to the arrival at the port of entry: said establishment. (a) They shall be consigned from the coast or border port of arrival to an ap- (Approved by the Office of Management and proved establishment and shall be sub- Budget under control number 0579–0015) ject to disinfection by such method or [28 FR 5981, June 13, 1963, as amended by 59 methods as the Deputy Administrator, FR 67134, Dec. 29, 1994; 74 FR 66227, Dec. 15, Veterinary Services may prescribe un- 2009; 76 FR 28887, May 19, 2011] less the said establishment discharges drainage into an approved sewerage § 95.7 Wool, hair, and bristles; require- system or has an approved chlorinating ments for unrestricted entry. equipment adequate for the proper dis- Wool, hair, or bristles derived from infection of effluents: Provided, how- ruminants and/or swine which do not ever, That upon permission of the Dep- meet the conditions or requirements uty Administrator, Veterinary Serv- specified in any one of paragraphs (a) ices such hides or skins or bird trophies to (d) of this section shall not be im- may be stored for a temporary period ported except subject to handling and in approved warehouses under bond, treatment in accordance with § 95.8 and under the supervision of an inspec- after their arrival at the port of entry: tor: And provided further, That I. T. or Provided, however, That no bloodstained inbound shipments of hides or skins or wool, hair, or bristles shall be imported bird trophies may go forward under under any condition:

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(a) Such wool, hair, or bristles may (a) Such wool, hair, or bristles shall be imported without other restriction be consigned from the coast or border if originating in and shipped directly port of arrival to an approved estab- from a region not declared by the Sec- lishment: Provided, however, That upon retary of Agriculture to be infected permission by the Deputy Adminis- with foot-and-mouth disease or rinder- trator, Veterinary Services such wool, pest. hair, or bristles may be stored for a (b) Wool or hair clipped from live ani- temporary period in approved ware- mals or pulled wool or hair may be im- houses under bond and under the super- ported without other restriction if the vision of an inspector: And provided fur- said wool or hair is reasonably free ther, That I. T. on in-bond shipments of from animal manure in the form of wool, hair, or bristles may go forward dung locks or otherwise. under customs seals from a coast or (c) Wool, hair, or bristles taken from border port of arrival, with the ap- sheep, goats, cattle, or swine, when proval of an inspector at said port, to such animals have been slaughtered another port for consumption entry, under national government inspection subject to the other provisions of this in a region 3 and in an abattoir in section. which is maintained an inspection (b) Such wool, hair, or bristles shall service determined by the Secretary of be moved from the coast or border port Agriculture to be adequate to assure of arrival or, in the case of I. T. or in- that such materials have been removed bond shipments, from the interior port from animals found at time of slaugh- to the establishment in cars or trucks ter to be free from anthrax, foot-and- or in vessel compartments with no mouth disease, and rinderpest, and to other materials contained therein, assure further the identity of such ma- sealed with seals of the Department, terials until loaded upon the trans- which shall not be broken except by in- porting vessel, may be imported with- spectors or other persons authorized by out other restriction if accompanied by the Deputy Administrator, Veterinary a certificate bearing the seal of the Services so to do, or without sealing as proper department of said national aforesaid and with other freight when government and signed by an official packed in tight cases acceptable to an veterinary inspector of such region inspector. showing that the therein described (c) Such wool, hair, or bristles shall wool, hair, or bristles were taken from be handled at the establishment under animals slaughtered in such specified the direction of an inspector in a man- abattoir and found free from anthrax, ner approved by the Deputy Adminis- foot-and-mouth disease, and rinderpest. trator, Veterinary Services to guard (d) Wool, hair, or bristles which have against the dissemination of foot-and- been scoured, thoroughly washed, or mouth disease and rinderpest. Such dyed may be imported without other products shall not be removed there- restriction. from except upon special permission of the Deputy Administrator, Veterinary (Approved by the Office of Management and Budget under control number 0579–0015) Services and upon compliance with all the conditions and requirements of this [28 FR 5981, June 13, 1963, as amended at 48 section relative to the movement of FR 57472, Dec. 30, 1983; 62 FR 56024, Oct. 28, the said wool, hair, or bristles from the 1997; 74 FR 66226, Dec. 15, 2009] port of arrival to the said establish- § 95.8 Wool, hair, and bristles; importa- ment. tions permitted subject to restric- (Approved by the Office of Management and tions. Budget under control number 0579–0015) Wool, hair, or bristles offered for im- [28 FR 5981, June 13, 1963, as amended by 59 portation which do not meet the condi- FR 67134, Dec. 29, 1994] tions or requirements of § 95.7 shall be handled and treated in the following § 95.9 Glue stock; requirements for un- manner after arrival at the port of restricted entry. entry: Glue stock which does not meet the conditions or requirements specified in 3 See footnote 2 in § 95.5. any one of paragraphs (a) to (c) of this

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section shall not be imported except (a) It shall be consigned from the subject to handling and treatment in coast or border port of arrival to an ap- accordance with § 95.10 after arrival at proved establishment and shall be sub- the port of entry: ject to disinfection by such method or (a) Glue stock originating in and methods as the Deputy Administrator, shipped directly from a region not de- Veterinary Services may prescribe un- clared by the Secretary of Agriculture less the said establishment discharges to be infected with foot-and-mouth dis- drainage into an approved sewerage ease or rinderpest may be imported system or has an approved chlorinating without other restriction. equipment adequate for the proper dis- (b) Glue stock may be imported with- infection of effluents: Provided, how- out other restriction if found upon in- ever, That upon permission by the Dep- spection by an inspector, or by certifi- uty Administrator, Veterinary Serv- cate of the shipper or importer satis- ices glue stock may be stored for a factory to said inspector, to have been temporary period in approved ware- properly treated by acidulation or by houses under bond and under the super- soaking in milk of lime or a lime paste; vision of an inspector: And provided fur- or to have been dried so as to render ther, That I. T. or in-bond shipments of each piece of the hardness of a sun- glue stock may go forward under cus- dried hide. toms seals from a coast or border port (c) Glue stock taken from cattle, of arrival with the approval of an in- sheep, goats, or swine slaughtered spector at said port to another port for under national government inspection consumption entry, subject, after ar- in a region 4 and in an abattoir in rival at the latter port, to the other which is maintained an inspection provisions of this section. service determined by the Secretary of (b) It shall be moved from the coast Agriculture to be adequate to assure or border port of arrival or, in case of that such materials have been removed I. T. or in-bond shipments, from the in- from animals found at time of slaugh- terior port to the establishment in cars ter to be free from anthrax, foot-and- or trucks or in vessel compartments mouth disease, and rinderpest, and to with no other materials contained assure further the identity of such ma- therein, sealed with seals of the De- terials until loaded upon the trans- partment, which shall not be broken porting vessel, may be imported with- except by inspectors or other persons out other restriction if accompanied by authorized by the Deputy Adminis- a certificate bearing the seal of the trator, Veterinary Services so to do, or proper department of said national without sealing as aforesaid and with government and signed by an official other freight when packed in tight veterinary inspector of such region cases or casks acceptable to an inspec- showing that the therein described glue tor at port of entry. stock was taken from animals slaugh- (c) It shall be handled at the estab- tered in such specified abattoir and lishment under the direction of an in- found free from anthrax foot-and- spector in a manner approved by the mouth disease, and rinderpest. Deputy Administrator, Veterinary Services to guard against the dissemi- (Approved by the Office of Management and Budget under control number 0579–0015) nation of foot-and-mouth disease and rinderpest. It shall not be removed [28 FR 5981, June 13, 1963, as amended at 48 therefrom except upon special permis- FR 57472, Dec. 30, 1983; 62 FR 56024, Oct. 28, 1997; 74 FR 66226, Dec. 15, 2009] sion of the Deputy Administrator, Vet- erinary Services and upon compliance § 95.10 Glue stock; importations per- with all the conditions and require- mitted subject to restrictions. ments of this section relative to the Glue stock offered for importation movement of the said glue stock from which does not meet the conditions or the port of arrival to the said estab- requirements of § 95.9 shall be handled lishment. and treated in the following manner (Approved by the Office of Management and after arrival at the port of entry: Budget under control number 0579–0015) [28 FR 5981, June 13, 1963, as amended by 59 4 See footnote 2 in § 95.5. FR 67134, Dec. 29, 1994]

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§ 95.11 Bones, horns, and hoofs for tro- subject to the other provisions of this phies or museums; disinfected section. hoofs. (b) They shall be moved from the (a) Clean, dry bones, horns, and coast or border port of arrival or, in hoofs, that are free from undried pieces case of I. T. or in-bond shipments, from of hide, flesh, and sinew and are offered the interior port to the establishment for entry as trophies or for consign- in cars or trucks with no other mate- ment to museums may be imported rials contained therein, sealed with without other restrictions. seals of the Department, which shall not be broken except by inspectors or (b) Clean, dry hoofs disinfected in the other persons authorized by the Deputy region of origin may be imported with- Administrator, Veterinary Services so out other restrictions if the following to do, or without sealing as aforesaid conditions are met: and with other freight when packed in (1) The hoofs have been disinfected tight cases or casks acceptable to an using one of the following methods: inspector at the port of entry. ° ° (i) Dry heat at 180 F (82.2 C) for 30 (c) They shall be handled at the es- minutes; tablishment under the direction of an (ii) Soaking in boiling water for 20 inspector in a manner to guard against minutes; the dissemination of anthrax, foot-and- (iii) Soaking in a 0.1 percent chlorine mouth disease, and rinderpest, and the bleach solution for 2 hours; bags, burlap, or other containers there- (iv) Soaking in a 5 percent acetic of, before leaving the establishment, acid solution for 2 hours; or shall be disinfected by heat or other- (v) Soaking in a 5 percent hydrogen wise, as directed by the Deputy Admin- peroxide solution for 2 hours. istrator, Veterinary Services or burned (2) The hoofs are accompanied by a at the establishment. They shall not be certificate issued by the national gov- removed therefrom except upon special ernment of the region of origin and permission of the Deputy Adminis- signed by an official veterinary inspec- trator, Veterinary Services and upon tor of that region stating that the compliance with all the conditions and hoofs have been disinfected and de- requirements of this section relative to scribing the manner in which the dis- the movement of the said bones, horns, infection was accomplished. and hoofs. [28 FR 5981, June 13, 1963, as amended at 59 (Approved by the Office of Management and FR 9400, Feb. 28, 1994; 62 FR 56024, Oct. 28, Budget under control number 0579–0015) 1997] [28 FR 5981, June 13, 1963, as amended by 59 FR 67134, Dec. 29, 1994] § 95.12 Bones, horns, and hoofs; importations permitted subject to restric- § 95.13 Bone meal for use as fertilizer tions. or as feed for domestic animals; re- Bones, horns, and hoofs offered for quirements for entry. importation which do not meet the Steamed or degelatinized or special conditions or requirements of § 95.11 steamed bone meal, which, in the nor- shall be handled and treated in the fol- mal process of manufacture, has been lowing manner after arrival at the port prepared by heating bone under a min- of entry: imum of 20 pounds steam pressure for (a) They shall be consigned from the at least one hour at a temperature of coast or border port of arrival to an ap- not less than 250 °Fahrenheit (121 proved establishment having facilities °Centigrade), may be imported without for their disinfection or their conver- further restrictions for use as fertilizer sion into products customarily made or as feed for domestic animals if such from bones, horns, or hoofs: Provided, products are free from pieces of bone, however, That I. T. or in-bond ship- hide, flesh, and sinew and contain no ments of bones, horns, or hoofs may go more than traces of hair and wool. forward under customs seals from a Bone meal for use as fertilizer or as coast or border port of arrival, with the feed for domestic animals which does approval of an inspector at said port, not meet these requirements will not to another port for consumption entry be eligible for entry.

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§ 95.14 Blood meal, tankage, meat ever, That upon permission by the Dep- meal, and similar products, for use uty Administrator, Veterinary Serv- as fertilizer or animal feed; require- ices they may be stored for a tem- ments for entry. porary period in approved warehouses Dried blood or blood meal, lungs or under bond and under the supervision other organs, tankage, meat meal, of an inspector: And provided further, wool waste, wool manure, and similar That I. T. or in-bond shipments of such products, for use as fertilizer or as feed products may go forward under cus- for domestic animals, shall not be im- toms seals from a coast or border port ported except subject to handling and of arrival, with the approval of an in- treatment in accordance with para- spector at said port, to another port of graphs (a), (b), and (c) of § 95.16, unless: consumption entry, subject after ar- (a) Such products originated in and rival at the latter port to the other were shipped directly from a region not provisions of this section. declared by the Secretary of Agri- (b) They shall be moved from the culture to be infected with foot-and- coast or border port of arrival or, in mouth disease or rinderpest; or the case of I. T. or in-bond shipments, (b) The inspector at the port of entry from the interior port to the establish- finds that such products have been ment in cars or trucks or in vessel fully processed by tanking under live compartments with no other materials steam or by dry rendering. contained therein, sealed with seals of the Department, which shall not be [28 FR 5981, June 13, 1963, as amended at 62 broken except by Veterinary Services FR 56024, Oct. 28, 1997] inspectors or other persons authorized § 95.15 Blood meal, blood albumin, in- by the Deputy Administrator, Veteri- testines, and other animal byprod- nary Services so to do, or without seal- ucts for industrial use; require- ing as aforesaid and with other freight ments for unrestricted entry. when packed in tight cases or casks ac- Blood meal, blood albumin, bone ceptable to an inspector at the port of meal, intestines, or other animal mate- entry. rials intended for use in the industrial (c) They shall be handled at the es- arts shall not be imported except sub- tablishment under the direction of an ject to handling and treatment in ac- inspector in a manner to guard against cordance with § 95.16, unless such prod- the dissemination of foot-and-mouth ucts originated in and were shipped di- disease and rinderpest. They shall not rectly from a region not declared by be removed therefrom except upon spe- the Secretary of Agriculture to be in- cial permission of the Deputy Adminis- fected with foot-and-mouth disease or trator, Veterinary Services and upon rinderpest. compliance with all the conditions and requirements of this section relative to (Approved by the Office of Management and the movement of the said products Budget under control number 0579–0015) from the port of arrival to the said es- [28 FR 5981, June 13, 1963, as amended by 59 tablishment. FR 67134, Dec. 29, 1994; 62 FR 56024, Oct. 28, 1997] (Approved by the Office of Management and Budget under control number 0579–0015) § 95.16 Blood meal, blood albumin, in- [28 FR 5981, June 13, 1963, as amended by 59 testines, and other animal byprod- FR 67134, Dec. 29, 1994] ucts for industrial use; importations permitted subject to restrictions. § 95.17 Glands, organs, ox gall, and like Blood meal, blood albumin, bone materials; requirements for unre- meal, intestines, or other animal mate- stricted entry. rials intended for use in the industrial Glands, organs, ox gall or bile, bone arts, which do not meet the conditions marrow, and various like materials de- or requirements of § 95.15 shall be han- rived from domestic ruminants or dled and treated in the following man- swine, intended for use in the manufac- ner after arrival at the port of entry. ture of pharmaceutical products shall (a) They shall be consigned from the not be imported except subject to han- coast or border port of arrival to an ap- dling and treatment in accordance with proved establishment: Provided, how- § 95.18, unless such glands, organs, or

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materials originated in and were Administrator, Veterinary Services shipped directly from a region not de- may deem necessary in each instance. clared by the Secretary of Agriculture (Approved by the Office of Management and to be infected with foot-and-mouth dis- Budget under control number 0579–0015) ease or rinderpest. [28 FR 5981, June 13, 1963, as amended by 59 [28 FR 5981, June 13, 1963, as amended at 62 FR 67134, Dec. 29, 1994] FR 56024, Oct. 28, 1997] § 95.20 Animal manure. § 95.18 Glands, organs, ox gall, and like Manure of horses, cattle, sheep, other materials; importations permitted ruminants, and swine shall not be im- subject to restrictions. ported except upon permission from Glands, organs, ox gall or bile, bone the Deputy Administrator, Veterinary marrow, and various like materials de- Services. Importations permitted shall rived from domestic ruminants or be subject to such restrictions as he may deem necessary in each instance: swine, which do not meet the require- Provided, however, That manure pro- ments of § 95.17 may be imported for duced by animals while in transit to pharmaceutical purposes if in tight the United States shall be subject only containers and consigned to an ap- to the requirements of the Department proved establishment: Provided, how- regulations governing the importation ever, That upon special permission of of domestic livestock and other ani- the Deputy Administrator, Veterinary mals. Services they may be stored for a temporary period in approved warehouses (Approved by the Office of Management and Budget under control number 0579–0015) under bond and under the supervision of an inspector. They shall be handled [28 FR 5981, June 13, 1963, as amended by 59 FR 67134, Dec. 29, 1994] and processed at the said establishment in a manner approved by the Dep- § 95.21 Hay and straw; requirements uty Administrator, Veterinary Serv- for unrestricted entry. ices and the containers shall be de- Except as provided in § 95.28, hay or stroyed or disinfected as prescribed by straw shall not be imported except sub- him. They shall not be removed there- ject to handling and treatment in ac- from except upon special permission of cordance with § 95.22 after arrival at the Deputy Administrator, Veterinary the port of entry, unless such hay or Services and upon compliance with all straw originated in and was shipped di- the conditions and requirements of this rectly from a region not declared by section relative to the movement of the Secretary of Agriculture to be in- the said glands, organs, ox gall, and fected with foot-and-mouth disease or like materials from the port of arrival rinderpest. to the said establishment. [28 FR 5981, June 13, 1963, as amended at 62 FR 56024, Oct. 28, 1997] (Approved by the Office of Management and Budget under control number 0579–0015) § 95.22 Hay and straw; importations [28 FR 5981, June 13, 1963, as amended at 59 permitted subject to restrictions. FR 67134, Dec. 29, 1994] Except as provided in § 95.28, hay or straw which does not meet the condi- § 95.19 Animal stomachs. tions or requirements of § 95.21 shall be Stomachs or portions of the stom- handled and treated in the following achs of ruminants or swine, other than manner upon arrival at the port of those imported for food purposes under entry: the meat-inspection regulations of the (a) Hay or straw packing materials Department, shall not be imported shall be burned or disinfected at the ex- without permission from the Deputy pense of the importer or consignee in Administrator, Veterinary Services. the manner and at the time directed by Importations permitted shall be sub- the Deputy Administrator, Veterinary ject to such restrictions as the Deputy Services. (b) Hay or straw for use as feeding material, bedding, or similar purposes

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shall be stored and held in quarantine § 95.24 Methods for disinfection of for a period of not less than 90 days in hides, skins, and other materials. an approved warehouse at the port of Hides, skins, and other materials re- entry and shall be otherwise handled as quired by the regulations in this part directed by the Deputy Administrator, to be disinfected shall be subjected to Veterinary Services. disinfection by methods found satisfactory and approved from time to time § 95.23 Previously used meat covers; importations permitted subject to by the Deputy Administrator, Veteri- restrictions. nary Services. Cloth or burlap which has been used § 95.25 Transportation of restricted im- to cover fresh or frozen meats origi- port products; placarding cars and nating in any region designated in § 94.1 marking billing; unloading enroute. of this subchapter as a region in which (a) Transportation companies or rinderpest or foot-and-mouth disease other operators of cars, trucks or other exists, shall not be imported except vehicles carrying import products or under the following conditions: materials moving under restriction, (a) The cloth or burlap shall be con- other than those in tight cases or signed from the coast or border port of casks, shall affix to and maintain on arrival to an establishment specifically both sides of all such vehicles durable approved for the purpose by the Deputy placards not less than 51⁄2 by 6 inches in Administrator, Veterinary Services. size, on which shall be printed with (b) The cloth or burlap shall be im- permanent black ink and in boldface mediately moved from the coast or letters not less than 11⁄2 inches in border port of arrival, or in case of I. T. height the words ‘‘Restricted import or in-bond shipments from the interior product.’’ These placards shall also port, to the establishment, in railroad bear the words ‘‘Clean and disinfect cars or trucks, or in vessel compart- this car or truck.’’ Each of the way- ments, with no other material con- bills, conductors’ manifests, memo- tained therein, sealed with seals of the randa, and bills of lading pertaining to Department, which shall not be broken such shipments shall have the words except by inspectors or other persons ‘‘Restricted import product, clean and authorized by the Deputy Adminis- disinfect car or truck,’’ plainly written trator, Veterinary Services: Provided, or stamped upon its face. If for any rea- however, That upon permission of the son the placards required by this sec- Deputy Administrator, Veterinary tion have not been affixed to each car, Services, such cloth or burlap may be or the billing has not been marked by stored for a temporary period in ap- the initial or the connecting carrier, or proved warehouses at the port of ar- the placards have been removed, de- rival under bond and under the super- stroyed, or rendered illegible, the plac- vision of an inspector. ards shall be immediately affixed or re- (c) The material shall be disinfected placed and the billing marked by the and otherwise handled at the establish- initial or connecting carrier, the inten- ment under the direction of an inspection being that the billing accom- tor in a manner approved by the Dep- panying the shipment shall be marked uty Administrator, Veterinary Serv- and each car, truck or other vehicle ices to guard against the dissemination placarded as specified in this section of foot-and-mouth disease and rinder- from the time such shipment leaves the pest, and the material shall not be report of entry until it is unloaded at moved therefrom, except upon special final destination and the cars, trucks permission of the Deputy Adminis- or other vehicles are cleaned and dis- trator, Veterinary Services, until all of infected as required by § 95.26. the conditions and requirements of this (b) If it is necessary to unload section have been complied with. enroute any of the materials or prod- (Approved by the Office of Management and ucts transported in a placarded car, Budget under control number 0579–0015) truck or other vehicle as provided in [28 FR 5981, June 13, 1963, as amended by 59 this section, the car, truck or other ve- FR 67134, Dec. 29, 1994; 62 FR 56024, Oct. 28, hicle from which the transfer is made 1997] and any part of the premises in or upon

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which the product or material may thorized representative of Veterinary have been placed in the course of un- Services is not maintained or where loading or reloading shall be cleaned proper facilities cannot be provided, and disinfected by the carrier, in ac- the transportation company shall seal, cordance with the provisions of § 95.26, bill, and forward the cars in which the and the said carrier shall immediately products or materials were transported report the matter, by telegraph, to the to a point to be agreed upon between Deputy Administrator, Veterinary the transportation company and Vet- Services, Washington, DC 20251. Such erinary Services, and the transpor- report shall include the following in- tation company shall there clean and formation: Nature of emergency; place disinfect the said cars under the super- where product or material was un- vision of Veterinary Services. loaded; original points of shipment and (b) Methods of cleaning and dis- destination; number and materials of infecting. (1) Railroad cars, trucks, air- the original car or truck; and number craft and means of conveyance other and initials of the car, truck or other than boats, equipment or containers, vehicle into which the product or ma- required by this part to be cleaned and terial is reloaded in case the original disinfected shall be treated in the fol- car or truck is not used. lowing manner: Collect all litter and (Approved by the Office of Management and other refuse therefrom and destroy by Budget under control number 0579–0015) burning or other approved method, [28 FR 5981, June 13, 1963, as amended at 48 clean the exterior and interior of the FR 57472, Dec. 30, 1983] cars or trucks, and the areas of the aircraft or other means of conveyance, § 95.26 Railroad cars, trucks, boats, equipment or containers that may have aircraft and other means of convey- been contaminated, and saturate the ance, equipment or containers, entire surface with a permitted dis- yards, and premises; cleaning and disinfection. infectant approved for use in this part. (2) Boats required by this part to be Railroad cars, trucks, boats, aircraft cleaned and disinfected shall be treated and other means of conveyance, equip- in the following manner: Collect all lit- ment or containers, yards, and prem- ter and other refuse from the decks, ises which have been used in the trans- compartments, and all other parts of portation, handling, or storing of restricted import products or materials, the boat used for the transportation of other than those contained in leak the products or materials covered by proof cases or casks, shall be cleaned this part, and from the portable chutes and disinfected with a disinfectant ap- or other appliances, fixtures or areas proved for use in this part under the used in loading and unloading same, supervision of the division at the time and destroy the litter and other refuse and in the manner provided in this sec- by burning or by other approved meth- tion. Except as provided in paragraph ods, and saturate the entire surface of (a) of this section, such railroad cars, the said decks, compartments, and trucks, boats, aircraft and other means other parts of the boat with a per- of conveyance, equipment or con- mitted disinfectant approved for use in tainers, shall not be moved in inter- this part. state or foreign commerce until they (3) Buildings, sheds, and premises re- have been so treated. quired by this part to be disinfected (a) Cars to be cleaned and disinfected shall be treated in the following man- by final carrier at destination. Cars re- ner: Collect all litter and other refuse quired by this part to be cleaned and therefrom and destroy the same by disinfected shall be so treated by the burning or other approved methods, final carrier at destination as soon as and saturate the entire surface of the possible after unloading and before the fencing, chutes, floors, walls, and other same are moved from such final des- parts with a permitted disinfectant ap- tination for any purpose: Provided, proved for use in this part. however, That when the products or (c) Permitted disinfectants. The dis- materials are destined to points at infectants permitted for use in dis- which an inspector or other duly au- infecting railroad cars, trucks, boats,

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aircraft and other means of convey- from any place under the jurisdiction ance, equipment or containers, yards, of the United States to which the ani- and premises against infection of foot- mal-quarantine laws of this country do and-mouth disease and rinderpest are not apply. freshly prepared solutions of: (1) Sodium carbonate (4 percent) in § 95.28 Hay or straw and similar mate- the proportion of 1 pound to 3 gallons rial from tick-infested areas. of water. Hay or straw, grass, or similar mate- (2) Sodium carbonate (4 percent) plus rial from tick-infested pastures, sodium silicate (0.1 percent) in the pro- ranges, or premises may disseminate portion of 1 pound of sodium carbonate the contagion of splenetic, Southern or plus sodium silicate to 3 gallons of Texas fever when imported for animal water. feed or bedding; therefore, such hay or (3) Sodium hydroxide (Lye) prepared straw, grass, or similar materials shall in a fresh solution in the proportion of not be imported unless such material is not less than 1 pound avoirdupois of so- first disinfected with a disinfectant dium hydroxide of not less than 95 per- specified in § 95.26(d). cent purity to 6 gallons of water, or one 131⁄2-ounce can to 5 gallons of § 95.29 Certification for certain mate- water. 5 rials. (d) Permitted disinfectants against (a) In addition to meeting any other ticks. The disinfectants permitted for certification or permit requirements of use against tick infestation are lique- this chapter, the following articles fied phenol (U. S. P. strength 87 per- may be imported into the United cent phenol) in the proportion of at States from any region not listed in least 6 fluid ounces to one gallon of § 94.18(a) only if they are accompanied water; or chlorinated lime (U. S. P. by a certificate, as described in para- strength 30 percent available chlorine) graph (b) of this section: in the proportion of one pound to three (1) Processed animal protein, tank- gallons of water; or any one of the cre- age, offal, and tallow other than tallow sylic disinfectants permitted by the derivatives, unless, in the opinion of Animal and Plant Health Inspection the Administrator, the tallow cannot Service in the proportion of at least be used in feed, regardless of the ani- four fluid ounces to one gallon of mal species from which the material is water; or through application of boil- derived; ing water if the treatment is against (2) Glands and unprocessed fat tissue rinder-pest or foot-and-mouth disease derived from ruminants; and tick infestation; or other disinfect- (3) Processed fats and oils, and de- ants or treatments approved by the rivatives of processed animal protein, Deputy Administrator, Veterinary tankage, and offal, regardless of the Services. animal species from which the mate- [28 FR 5981, June 13, 1963, as amended at 32 rial is derived; FR 19157, Dec. 20, 1967; 74 FR 66226, Dec. 15, (4) Derivatives of glands from 2009] ruminants; and (5) Any product containing any of the § 95.27 Regulations applicable to products from Territorial possessions. materials listed in paragraphs (a)(1) through (a)(4) of this section. The regulations in this part shall be (b) The certificate required by para- applicable to all the products and ma- graph (a) of this section must be an terials specified in this part which are original official certificate, signed by a offered for entry into the United States full-time, salaried veterinarian of the agency responsible for animal health in 5 Due to the extreme caustic nature of so- the exporting region, that states the dium hydroxide solution, precautionary following: measures such as the wearing of rubber (1) The animal species from which gloves, boots, raincoat and goggles should be observed. An acid solution such as vinegar the material was derived; shall be kept readily available in case any of (2) The region in which any facility the sodium hydroxide solution should come where the material was processed is loin contact with the body. cated;

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(3) That the material was derived PART 96—RESTRICTION OF IMPOR- only from animals that have never TATIONS OF FOREIGN ANIMAL been in any region listed in § 94.18(a) of CASINGS OFFERED FOR ENTRY this chapter, with the regions listed in § 94.18(a) specifically named; INTO THE UNITED STATES (4) That the material did not origi- Sec. nate in, and was never stored in, ren- 96.1 Definitions. dered or processed in, or otherwise as- 96.2 Prohibition of casings due to African sociated with a facility in a region list- swine fever and bovine spongiform ed in § 94.18(a); and encephalopathy. (5) The material was never associated 96.3 Certificate for animal casings. with any of the materials listed in 96.4 Uncertified animal casings; disposition. 96.5 Instructions regarding handling cer- paragraph (a) of this section that have tified animal casings. been in a region listed in § 94.18(a). 96.6 Certified foreign animal casings arriv- (c) The certification required by ing at seaboard or border port. paragraph (a) of this section must 96.7 Dried bladders, weasands, and casings. clearly correspond to the shipment by 96.8 Uncertified casings; disinfection at sea- means of an invoice number, shipping board port. 96.9 Casings admitted on disinfection; seal- marks, lot number, or other method of ing; transfer and disinfection. identification. 96.10 Uncertified casings; transportation for disinfection; original shipping con- (Approved by the Office of Management and tainers; disposition of salt. Budget under control number 0579–0183) 96.11 Disinfecting plant and equipment for [66 FR 42601, Aug. 14, 2001] uncertified casings. 96.12 Uncertified casings not disinfected in § 95.30 Restrictions on entry of prod- 30 days; disposition. ucts and byproducts of poultry, 96.13 Uncertified casings; disinfection with game birds, or other birds from re- hydrochloric acid. gions where highly pathogenic 96.14 Uncertified casings; disinfection with avian influenza (HPAI) exists. saturated brine solution. (a) Products or byproducts, including AUTHORITY: 7 U.S.C. 8301–8317; 21 U.S.C. 136 feathers, birds’ nests, and bird tro- and 136a; 7 CFR 2.22, 2.80, and 371.4. phies, of poultry, game birds, or other SOURCE: 28 FR 5986, June 13, 1963, unless birds may be imported from a region otherwise noted. identified in accordance with § 94.6(a)(2) of this subchapter as a region where § 96.1 Definitions. HPAI exists only if the Administrator Administrator. The Administrator, has determined that the importation Animal and Plant Health Inspector can be made under conditions that will Service, or any person authorized to prevent the introduction of HPAI into act for the Administrator. the United States. The articles must be Animal and Plant Health Inspection accompanied by a permit obtained Service. The Animal and Plant Health from APHIS prior to the importation Inspection Service of the United States in accordance with paragraph (b) of Department of Agriculture (APHIS or this section, and they must be moved Service). and handled as specified on the permit Animal casings. Intestines, stomachs, to prevent the introduction of HPAI esophagi, and urinary bladders from into the United States. cattle, sheep, swine, or goats that are (b) To apply for a permit, contact the used to encase processed meats in foods Animal and Plant Health Inspection such as sausage. Service, Veterinary Services, National APHIS representative. An individual Center for Import and Export, 4700 employed by APHIS who is authorized River Road Unit 38, Riverdale, Mary- to perform the function involved. land 20737–1231. Authorized inspector. Any individual authorized by the Administrator of (Approved by the Office of Management and APHIS or the Commissioner of Cus- Budget under control number 0579–0245) toms and Border Protection, Depart- [69 FR 25826, May 10, 2004, as amended at 76 ment of Homeland Security, to enforce FR 4055, Jan. 24, 2011] the regulations in this subpart.

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Department. The United States De- gion listed under § 94.8(a) of this sub- partment of Agriculture. chapter in a closed container sealed Food and Drug Administration. The with serially numbered seals applied by Food and Drug Administration of the an official of the national government United States Department of Health of the region of origin. and Human Services. (3) Origin certificate. The casings were Food Safety and Inspection Service. accompanied from the region of origin The Food Safety and Inspection Serv- to the processing establishment by a ice of the United States Department of certificate written in English and Agriculture. signed by an official of the national Import (imported, importation) into the government of the region of origin United States. To bring into the terri- specifying the region of origin, the torial limits of the United States. processing establishment to which the Region. Any defined geographic land swine casings were consigned, and the area identifiable by geological, polit- numbers of the seals applied. ical, or surveyed boundaries. A region (4) Integrity of seals. The casings were may consist of any of the following: taken out of the container at the proc- (1) A national entity (country); essing establishment only after an offi- (2) Part of a national entity (zone, cial of the national government of the county, department, municipality, par- region where the processing establish- ish, Province, State, etc.) ment is located determined that the (3) Parts of several national entities seals were intact and free of any evi- combined into an area; or dence of tampering and had so stated (4) A group of national entities (coun- on the certificate referred to in para- tries) combined into a single area. graph (a)(3) of this section. United States. All of the States of the (5) The processing establishment. The United States, the District of Colum- casings were processed at a single proc- bia, Guam, the Northern Mariana Is- essing establishment 1 in a region listed lands, Puerto Rico, the Virgin Islands under § 94.8(a) of this subchapter. The of the United States, American Samoa, processing establishment does not re- and the territories and possessions of ceive or process any live swine and uses the United States. only pork and pork products that originate in a region not listed under (Approved by the Office of Management and § 94.8(a) of this subchapter and that are Budget under control number 0579–0015) shipped to the processing establish- [57 FR 28082, June 24, 1992, as amended at 57 ment in accordance with paragraphs FR 29785, July 7, 1992; 59 FR 67134, Dec. 29, (a)(2) through (a)(4) of this section. 1994; 62 FR 56024, Oct. 28, 1997; 70 FR 553, Jan. (6) Compliance agreement. The proc- 4, 2005; 72 FR 53379, Sept. 18, 2007] essing establishment is operated by § 96.2 Prohibition of casings due to Af- persons who have entered into a valid rican swine fever and bovine written compliance agreement with spongiform encephalopathy. APHIS to maintain on file at the proc- (a) Swine casings. The importation of essing establishment for at least 2 swine casings that originated in or years copies of the certificates referred were processed in a region where Afri- to in paragraph (a)(4) of this section, to can swine fever exists, as listed under allow APHIS personnel to make unan- § 94.8(a) of this subchapter, is prohib- nounced inspections as necessary to ited, with the following exception: monitor compliance with the provi- Swine casings that are processed in a sions of this section, and to otherwise region where African swine fever exists comply with the provisions of this sec- may be imported into the United tion. States under the following conditions: (1) Origin of casings. The swine cas- 1 As a condition of entry into the United ings were derived from swine raised States, pork or pork products must also and slaughtered in a region not listed meet all of the requirements of the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) and under § 94.8(a) of this subchapter. regulations under the Act (9 CFR, chapter (2) Shipping requirements. The casings III, part 327), including requirements that were shipped from the region of origin the pork or pork products be prepared only to a processing establishment in a rein approved establishments.

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(7) Cooperative service agreement. The the swine casings in the United States, processing establishment is operated the certificate must be presented to an by persons who have entered into a co- authorized inspector at the port of ar- operative service agreement with rival. APHIS. The establishment is current (b) Ruminant casings. The importa- in paying for APHIS personnel to in- tion of casings, except stomachs, from spect the establishment (it is antici- ruminants that originated in or were pated that such inspections will occur processed in any region listed in once per year). In addition, the proc- § 94.18(a) of this subchapter is prohib- essing establishment has on deposit ited, except as provided in paragraphs with APHIS an unobligated amount (b)(1) and (b)(2) of this section: equal to the cost for APHIS personnel (1) Casings that are derived from to conduct one inspection, including sheep that were slaughtered in a region travel, salary, subsistence, administra- listed in § 94.18(a)(3) of this subchapter tive overhead, and other incidental ex- at less than 12 months of age and that penses (including excess baggage provi- were from a flock subject to a rumi- sions up to 150 pounds). nant feed ban equivalent to the re- (8) Compliance agreement cancellation. quirements established by the U.S. Any compliance agreement may be Food and Drug Administration at 21 canceled orally or in writing by the in- CFR 589.2000 may be imported. spector who is supervising its enforce- (2) Casings that are derived from bo- ment whenever the authorized inspec- vines that were slaughtered in a region tor finds that such person has failed to listed in § 94.18(a)(3) of this subchapter comply with the provisions of this sec- may be imported, provided, if the cas- tion or any conditions imposed by this ings are derived from the small intes- section. If the cancellation is oral, the tine, the casings are derived from that decision and the reasons will be con- part of the small intestine that is eligi- firmed in writing, as promptly as cir- ble for use as human food in accord- cumstances allow. Any person whose ance with the requirements established compliance agreement has been can- by the Food Safety and Inspection celed may appeal the decision to the Service at 9 CFR 310.22 and the Food Administrator, in writing, within 10 and Drug Administration at 21 CFR days after receiving written notifica- 189.5. tion of the cancellation. The appeal (3) Casings imported in accordance should state all of the facts and rea- with either paragraph (b)(1) or (b)(2) of sons upon which the person relies to this section must be accompanied by a show that the compliance agreement certificate that: was wrongfully canceled. The Adminis- (i) States that the casings meet the trator will grant or deny the appeal, in conditions of this section; writing, stating the reasons for such (ii) Is written in English; (iii) Is signed by an individual eligi- decision, as promptly as circumstances ble to issue the certificate required allow. If there is a conflict as to any under § 96.3; and material fact, a hearing will be held to (iv) Is presented to an authorized in- resolve such conflict. Rules of Practice spector at the port of entry. governing such a hearing will be adopted by the Administrator. (Approved by the Office of Management and (9) Export certification. The casings Budget under control number 0579–0015) are accompanied to the United States [65 FR 1307, Jan. 10, 2000, as amended at 70 by an original certificate stating that FR 553, Jan. 4, 2005; 72 FR 53379, Sept. 18, all of the requirements of this section 2007; 77 FR 1395, Jan. 10, 2012] have been met. The certificate must be written in English. The certificate § 96.3 Certificate for animal casings. must be issued by an official of the na- (a) No animal casings shall be im- tional government of the region in ported into the United States from any which the processing establishment is foreign region unless they are accom- located. The official must be author- panied by a certificate signed by either ized to issue the foreign meat inspec- (1) a veterinarian salaried by the nation certificate required by part 327 in tional government of the region in chapter III of this title. Upon arrival of which the animals were slaughtered

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and the casings were collected, and the region in which the animals were slaugh- who is authorized by the national gov- tered and the casings were collected.) ernment to conduct casings inspections Official title: llllllllllllllll and issue certificates, and who has in- Signature: llllllllllllllllll spected the casings before issuing the Official issuing the certificate. (Veterinarian certificate and determined that the salaried by the national government of the casings meet the criteria described in region in which the animals were slaughtered and the casings were collected.) the Foreign Official Certificate for Ani- Official title: llllllllllllllll mal Casings; or (2) a non-government (d) In addition to meeting the re- veterinarian authorized to issue the quirements of this section, the certifi- certificate by the national government of the region in which the animals were cate accompanying sheep casings from slaughtered and the casings were col- a region listed in § 94.18(a)(3) of this lected, who has inspected the casings subchapter must state that the casings before issuing the certificate and deter- meet the requirements of § 96.2(b)(1), mined that the casings meet the cri- and the certificate accompanying bo- teria described in the Foreign Official vine casings from a region listed in Certificate for Animal Casings. A cer- § 94.18(a)(3) of this subchapter must tificate issued by a non-government state that the casings meet the re- veterinarian is valid only if the certifi- quirements of § 96.2(b)(2). cate is endorsed by a veterinarian sala- (Approved by the Office of Management and ried by the national government of the Budget under control number 0579–0015) region in which the animals were slaughtered and the casings were col- [28 FR 5986, June 13, 1963, as amended at 48 FR 57472, Dec. 30, 1983. Redesignated and lected. amended at 57 FR 28082, June 24, 1992. Redes- (b) All signatures on the certificate ignated at 58 FR 47031, Sept. 7, 1993, as shall be original. amended at 62 FR 56024, Oct. 28, 1997; 70 FR (c) The certificate shall bear the in- 553, Jan. 4, 2005; 72 FR 53379, Sept. 18, 2007] signia of the national government of the region in which the animals were § 96.4 Uncertified animal casings; dis- slaughtered and the casings were col- position. lected, and shall be in the following Animal casings which are unaccom- form: panied by the required certificate, FOREIGN OFFICIAL CERTIFICATE FOR ANIMAL those shipped in sheepskins or other CASINGS skins as containers, and those found upon inspection to be unclean or un- Place (City) (Region) llllllllll sound when offered for importation llll (Date) llll into the United States shall be kept in I hereby certify that the animal casings herein described were derived from healthy customs custody until exported or de- animals (cattle, sheep, swine, or goats), stroyed, or until disinfected and which received, ante mortem and post denaturated as prescribed by the Ad- mortem veterinary inspections at the time ministrator, Animal and Plant Health of slaughter, are clean and sound, and were Inspection Service (APHIS) in §§ 96.5 prepared and handled only in a sanitary through 96.16. manner and were not subjected to contagion prior to exportation. [28 FR 5986, June 13, 1963. Redesignated and amended at 57 FR 28082, 28083, June 24, 1992; Kind of casings lllllllllllllll 57 FR 29785, July 7, 1992. Redesignated and Number of packages lllllllllllll amended at 58 FR 47031, Sept. 7, 1993] Weight lllllllllllllllllll

Identification marks on the packages lll § 96.5 Instructions regarding handling Consignor llllllllllllllllll certified animal casings. (Address) (a) Animal casings are not classed as Consignee llllllllllllllllll meat product, therefore the certificate (Destination) required for foreign meat product is Shipping marks lllllllllllllll not acceptable for animal casings of- Signature: llllllllllllllllll Official issuing the certificate. (Non-govern- fered for importation. ment veterinarian authorized to issue the (b) Casings offered for importation certificate by the national government of into the United States shall remain in

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customs custody at the port until re- are destined to a point in the United leased by an APHIS inspector for ad- States where an APHIS inspector is mission into the United States or oth- stationed, shall be shipped in United erwise disposed of as required by this States Customs custody to destination part. for release. (c) The provision that under certain (c) Properly certified foreign animal conditions casings which have been of- casing arriving in the United States at fered for importation shall be exported, a seaboard or border port where no shall be construed to mean the removal APHIS inspector is stationed, which of the casings from the United States are destined to a point in the United or its possessions. States where no APHIS inspector is (1) The provision that under certain stationed, shall be transported in conditions casings be destroyed shall United States Customs custody to the be construed to mean the treatment or nearest point where an APHIS inspec- handling of the casings in a manner to tor is stationed for release at that take away completely the usefulness of point. them as by tanking or incineration. (d) Properly certified foreign animal (2) The provision that under certain casings forming a part of a foreign conditions casings shall be disinfected meat consignment routed through a and denatured shall be construed to border port to an interior point in the mean such treatment and handling as United States shall be transported to will be prescribed by the Adminis- destination as though the entire con- trator, Animal and Plant Health In- signment consisted of meat. In such spection Service (APHIS) to free them cases the APHIS inspector who in- from pathogenic substances or orga- spects the meat at destination shall su- nisms, or to render such substances pervise the release of the casings. and organisms inert; and that the nature of the casings be changed to make [28 FR 5986, June 13, 1963, as amended at 57 FR 29785, July 7, 1992. Redesignated at 58 FR them unfit for eating without destroy- 47031, Sept. 7, 1993] ing other useful properties. For instance, each casing may be split § 96.7 Dried bladders, weasands, and throughout its length and after dis- casings. infection, as above indicated, be re- Dried animal bladders, dried leased for industrial use. weasands, and all other dried animal (d) Dried intestines offered for impor- casings offered for importation into the tation into the United States for use as United States as food containers unac- gut strings or similar purpose are not companied by foreign certification regarded as animal casings within the which have been retained in the dry meaning of this part. Such dried intes- state continuously for not less than 90 tines are classed with tendons, sinews, days from the date of shipment shown and similar articles and are subject to on the consular invoice, may be re- the provisions of part 95. leased for entry as food containers [28 FR 5986, June 13, 1963. Redesignated and without disinfection. amended at 57 FR 28082, 28083, June 24, 1992; 57 FR 29785, July 7, 1992. Redesignated at 58 [28 FR 5986, June 13, 1963. Redesignated at 58 FR 47031, Sept. 7, 1993] FR 47031, Sept. 7, 1993]

§ 96.6 Certified foreign animal casings § 96.8 Uncertified casings; disinfection arriving at seaboard or border port. at seaboard port. (a) Properly certified foreign animal Uncertified foreign animal casings casings arriving in the United States arriving at a seaboard port may be im- at a seaboard or border port where an ported into the United States for use as APHIS inspector is stationed shall be food containers after they have been released for entry by the inspector at disinfected under the direct supervision the seaboard or border port. of an APHIS inspector at the seaboard (b) Properly certified foreign animal port. casings arriving in the United States [28 FR 5986, June 13, 1963, as amended at 57 at a seaboard or border port where no FR 29785, July 7, 1992. Redesignated at 58 FR APHIS inspector is stationed, which 47031, Sept. 7, 1993]

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§ 96.9 Casings admitted on disinfec- one 131⁄2-ounce can to 5 gallons of tion; sealing; transfer and disinfec- water. 2 tion. (2) This solution shall be thoroughly Foreign animal casings offered for applied to all exterior surfaces of the importation into the United States containers and be allowed to remain which are admitted upon disinfection for at least thirty minutes to accom- shall be handled as follows: plish disinfection. The containers should then be washed with water to (a) The containers of such casings remove the caustic soda which other- shall be sealed on the steamship pier or wise might cause injury to the han- other place of first arrival. Four seals dlers of the packages. shall be affixed to both ends of each (b) When uncertified foreign casings tierce, barrel, and similar container in are removed from the original shipping the space where the ends of the con- containers these containers shall be de- tainer enter the staves, by means of stroyed by burning or promptly and red sealing wax imprinted with the No. thoroughly disinfected both inside and 3 Veterinary Services brass brand from out with the solution and in the man- which ‘‘INSP’D & P’S’D’’ and the estab- ner above prescribed. If these con- lishment number have been removed. tainers are to be re-used it is impor- (b) Uncertified animal casings sealed tant that they be thoroughly washed as above indicated shall be transferred both inside and out with water after from the steamship pier or other place disinfection has been completed, and in of first arrival to the premises of the order to insure against the injurious ef- importer or other designated place, fect of caustic soda remaining in the where they shall be disinfected by the wood it is advisable to allow the con- importer under the supervision of an tainers to stand for not less than six APHIS inspector before they are of- hours filled with water. fered for sale. The object of this ruling (c) The salt removed from all original is to place full responsibility for dis- shipping containers of uncertified for- infection of casings on the original im- eign animal casings shall be imme- porter and to prevent the sale of cas- diately dissolved in water and heated ings subject to disinfection by the pur- to boiling, or disposed of as provided in chaser. paragraph (c)(1) or (2) of this section as [28 FR 5986, June 13, 1963, as amended at 57 follows: FR 29785, July 7, 1992. Redesignated at 58 FR (1) Dissolve the salt in the proportion 47031, Sept. 7, 1993] of 90 pounds of salt to 100 gallons of water. Add 23⁄4 gallons of C. P. hydro- § 96.10 Uncertified casings; transpor- chloric acid containing not less than 35 tation for disinfection; original percent actual HCl; mix thoroughly shipping containers; disposition of and allow the solution to stand for at salt. least thirty minutes. The finished solu- (a) Foreign animal casings imported tion must contain not less than 1 per- into the United States without certifi- cent actual hydrochloric acid. (This so- cation may be forwarded in customs lution may be utilized in the disinfec- custody to a USDA-approved facility tion of casings as prescribed in § 96.13.) for disinfection under APHIS super- (2) Dissolve the salt in the proportion vision and release by the United States of 90 pounds of salt to 100 gallons of Customs authorities, provided that, be- water. Add 20 pounds of 95 percent to 98 fore being transported over land in the percent sodium hydroxide (commercial United States, each and every con- ‘‘76 percent caustic soda’’) and stir tainer of such casings shall be disinfected by the application of a solu- 2 Due to the extreme caustic nature of so- tion of sodium hydroxide prepared as dium hydroxide solution, and of sodium car- follows: bonate solution to a lesser degree, pre- (1) Sodium hydroxide (Lye) prepared cautionary measures such as the wearing of in a fresh solution in the proportion of rubber gloves, boots, raincoat and goggles not less than 1 pound avoirdupois of so- should be observed. An acid solution such as vinegar shall be kept readily available in dium hydroxide of not less than 95 per- case any of the sodium hydroxide solution cent purity to 6 gallons of water, or should come in contact with the body.

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until solution is complete; and allow it than 35 percent actual HCl and mix to stand for at least 30 minutes. (This throughly. The finished solution must solution may be utilized in the dis- contain not less than 1 percent actual infection of casing containers as pre- hydrochloric acid. scribed in paragraphs (a)(2) and (b) of (b) Containers of the disinfectant so- this section. lution may be either of wood or of (3) It is best to employ flaked caustic metal, but the interior surfaces must soda and not the variety which is very be protected by means of an acid resist- finely powdered. The fine powder is ir- ant coating. ritating and injurious to workers if it becomes suspended in the air. Con- (c) Not more than 175 pounds casings tainers of caustic soda should be kept shall be treated with each 100 gallons tightly closed as the product deterio- of the solution. After the treatment of rates from contact with the air. 175 pounds of casings, or at the end of the day if less than 175 pounds of cas- [28 FR 5986, June 13, 1963, as amended at 32 ings are disinfected in any one day, the FR 19158, Dec. 20, 1967; 57 FR 29785, July 7, 1992. Redesignated and amended at 58 FR solution shall be discarded unless 47031, Sept. 7, 1993; 62 FR 56024, Oct. 28, 1997; means are provided for accurately de- 65 FR 1307, Jan. 10, 2000] termining the loss of strength. In event means for accurately determining loss § 96.11 Disinfecting plant and equip- of strength are provided it will be per- ment for uncertified casings. missible to restore the strength of the Uncertified foreign animal casings solution with fresh acid and use it re- shall be disinfected only at a plant peatedly. whose sanitation and disinfecting (d) Shake as much of the adherent equipment have been approved by an salt as possible from the casings and APHIS inspector. weigh them. Bundles must be separated [28 FR 5986, June 13, 1963, as amended at 57 but individual hanks need not be un- FR 29785, July 7, 1992. Redesignated at 58 FR tied. Place the casings in the dis- 47031, Sept. 7, 1993] infecting solution a few hanks at a § 96.12 Uncertified casings not dis- time with vigorous agitation to insure infected in 30 days; disposition. the fullest possible contact of the solu- Foreign animal casings offered for tion with them. Then keep the casings importation without certification shall completely submerged in the solution be disinfected as prescribed in § 96.13 for not less than three-fourths of an within a period of 30 days after arrival hour. in the United States, subject to the (e) Remove the casings from the solu- ability of Division inspectors to cover tion, rinse them with water, and place their respective districts. Otherwise them in a solution containing 81⁄2 such casings shall be exported or de- pounds of sodium bicarbonate in each stroyed. 100 gallons of water. 100 gallons of this [28 FR 5986, June 13, 1963. Redesignated and solution is sufficient for 175 pounds of amended at 58 FR 47031, Sept. 7, 1993] casings. Keep the casings in this solution for 30 minutes, moving them about § 96.13 Uncertified casings; disinfec- frequently and vigorously so as to in- tion with hydrochloric acid. sure complete contact of the solution Foreign animal casings offered for with the casings. After this neutraliza- importation into the United States tion, remove the casings from the so- without certification may be dis- dium bicarbonate solution and wash infected, as prescribed in this section, them to remove the excess of bicarbon- under the supervision of an APHIS in- ate. spector for use as food containers, as an alternative for foreign certification. (Approved by the Office of Management and (a) Disinfect the casings in a solution Budget under control number 0579–0015) made as follows: Dissolve 90 pounds [28 FR 5986, June 13, 1963, as amended at 57 common salt in 100 gallons water and FR 29785, July 7, 1992. Redesignated at 58 FR mix. Add 23⁄4 gallons (10.35 liters) C. P. 47031, Sept. 7, 1993, as amended at 59 FR hydrochloric acid containing not less 67134, Dec. 29, 1994]

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§ 96.14 Uncertified casings; disinfec- ing thermometer should be located at a tion with saturated brine solution. point which would be approximately at Foreign animal casings offered for the bottom of the volume of casings importation into the United States being disinfected. upon disinfection, may either be dis- [28 FR 5986, June 13, 1963, as amended at 57 infected with hydrochloric acid as at FR 29785, July 7, 1992. Redesignated at 58 FR present or if preferred may be sub- 47031, Sept. 7, 1993] merged in a saturated brine solution at a temperature not less than 127 °F. for PART 97—OVERTIME SERVICES RE- at least 15 minutes. The time held as LATING TO IMPORTS AND EX- well as the temperature of such brine PORTS solution must be recorded on a one- hour dial of a recording thermometer Sec. and filed in the local APHIS office for 97.1 Overtime work at laboratories, border official inspection at any time. In ports, ocean ports, and airports. order that this required temperature 97.2 Administrative instructions prescribing may be more readily maintained, such commuted traveltime. casings must first be submerged in a AUTHORITY: 7 U.S.C. 8301–8317; 49 U.S.C. brine solution at approximately 127 °F. 80503; 7 CFR 2.22, 2.80, and 371.4. for about five minutes immediately before the 15-minute recorded submersion § 97.1 Overtime work at laboratories, period begins. This may be done either border ports, ocean ports, and air- in the testing vat or a preliminary vat. ports. 1 By following this procedure the tem- (a) Any person, firm, or corporation perature will not vary unduly and thus having ownership, custody, or control cause unsatisfactory results. After re- of animals, animal byproducts, or moving the casings from the testing other commodities or articles subject vat, it will be found advantageous to to inspection, laboratory testing, cer- submerge them in another vat con- tification, or quarantine under this taining cold brine solution or cold subchapter and subchapter G of this water in order to remove the extra chapter, and who requires the services heat from the casings as promptly as of an employee of the Animal and possible, but of course this is optional Plant Health Inspection Service on a with the importer. In order to obtain Sunday or holiday, or at any other the most satisfactory results, the time outside the regular tour of duty of hanks, rings, and similar units must be the employee, shall sufficiently in ad- separated as much as possible without vance of the period of Sunday or holi- untying, but ‘‘dolls’’ will not be per- day or overtime service request the mitted to be disinfected by this heating Animal and Plant Health Inspection method. In order to keep the tempera- Service inspector in charge to furnish ture of the brine in the testing vat of a the service and shall pay the Govern- uniform degree, it is necessary to agi- ment at the rate listed in the following tate the solution occasionally by mov- table, except as provided in paragraphs ing the casings. The tip of the record- (a)(1), (a)(2), and (a)(3) of this section:

OVERTIME FOR INSPECTION, LABORATORY TESTING, CERTIFICATION, OR QUARANTINE OF ANIMALS, ANIMAL PRODUCTS OR OTHER REGULATED COMMODITIES

Overtime rates (per hour) Outside the employee’s normal tour of duty Oct. 1, 2003–Sept. 30, Oct. 1, 2004–Sept. 30, 2004 2005 Beginning Oct. 1, 2005

Monday through Saturday and holidays ...... $48.00 $49.00 $51.00 Sundays ...... 63.00 65.00 67.00

1 For designated ports of entry for certain 93.403, 93.503, 93.703, and 93.805 and for des- animals, animal semen, poultry, and hatch- ignated ports of entry for certain purebred ing eggs see 9 CFR §§ 93.102, 93.203, 93.303, animals see 9 CFR §§ 151.1 through 151.3.

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(1) For any services performed on a (2) Owners and operators of aircraft Sunday or holiday, or at any time after will be provided service without reim- 5 p.m. or before 8 a.m. on a weekday, in bursement during regularly established connection with the arrival in or de- hours of service on a Sunday or holi- parture from the United States of a day; and private aircraft or private vessel, the (3) The overtime rate to be charged total amount payable shall not exceed owners or operators of aircraft at air- $25 for all inspection services per- ports of entry or other places of inspec- formed by the Customs Service, Immi- tion as a consequence of the operation gration and Naturalization Service, of the aircraft, for work performed outside of the regularly established hours Public Health Service, and the Depart- of service is listed in the following ment of Agriculture; table:

OVERTIME FOR COMMERCIAL AIRLINE INSPECTION SERVICES 1

Overtime rates (per hour) Outside the employee’s normal tour of duty Oct. 1, 2003–Sept. 30, Oct. 1, 2004–Sept. 30, 2004 2005 Beginning Oct. 1, 2005

Monday through Saturday and holidays ...... $39.00 $40.00 $41.00 Sundays ...... 51.00 53.00 55.00 1 These charges exclude administrative overhead costs.

(b) A minimum charge of 2 hours charged and the percentage applicable shall be made for any Sunday or holi- in each circumstance are as reflected day or unscheduled overtime duty per- in the following table: formed by an employee on a day when Com- no work was scheduled for him or her, Actual 2 1 2-hour muted or which is performed by an employee time guarantee traveltime charge—no charge (CTT) on his or her regular workday begin- minimum charge ning either at least 1 hour before his or her scheduled tour of duty or which is Charges for Inspection Within Metropolitan Area of Employee’s Headquarters not in direct continuation of the employee’s regular tour of duty. In addi- Work beginning tion, each such period of Sunday or before daily tour begins: holiday or unscheduled overtime work 8 to 59 min- Yes ...... No ...... None. to which the 2-hour minimum charge utes. applies may include a commuted trav- 60 to 119 min- ...... Yes ...... 1⁄2 CTT. eltime period (CTT) the amount of utes. 120 minutes ...... Yes ...... Full CTT. which shall be prescribed in adminis- or more. trative instructions to be issued by the Work beginning Administrator, Animal and Plant after daily tour ends: Health Inspection Service for the areas Direct continu- Yes ...... No ...... None. in which the Sunday or holiday or ation. overtime work is performed and such Break-in-service period shall be established as nearly as of: 2–29 minutes ...... Yes ...... None. may be practicable to cover the time 30–60 min- ...... Yes ...... 1⁄2 CTT. necessarily spent in reporting to and utes. returning from the place at which the 61 minutes or ...... Yes ...... Full CTT. employee performs such Sunday, holi- more. day or overtime duty. With respect to Charges for Inspection Services Performed Outside places of duty within the metropolitan Metropolitan Area of Employee’s Headquarters area of the employee’s headquarters, Work beginning such CTT period shall not exceed 3 before daily tour hours. It shall be administratively de- begins: termined from time to time which days 8 to 59 min- Yes ...... No ...... 1⁄2 CTT. utes. constitute holidays. The circumstances 60 minutes or ...... Yes ...... Full CTT. under which such CTT periods shall be more.

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difference to the agent, broker, or prin- Actual Com- 2-hour muted 2 time 1 cipal, or billing the agent, broker, or charge—no guarantee traveltime minimum charge (CTT) principal for the difference. charge (3) The prepayment must be in some Work beginning guaranteed form, such as money order, after daily tour certified check, or cash. Prepayment in ends: guaranteed form will continue until Direct continu- Yes ...... No ...... 1⁄2 CTT. ations. the Animal and Plant Health Inspec- 2–59 minutes No ...... Yes ...... 1⁄2 CTT. tion Service determines that the agent, 60 minutes or No ...... Yes ...... Full CTT. broker, or principal has established an more. acceptable credit history. Charges for Call Out Inspection Service on Holiday or (4) For security reasons, cash pay- Nonworkday ments will be accepted only from 7 a.m. to 5 p.m., and only at a location des- Work beginning at No ...... Yes ...... Full CTT. any time. ignated by the Animal and Plant Health Inspection Service inspector. 1 Actual time charged when work is contiguous with the daily tour will be in quarter hour multiples, with service time of (e)(1) Any principal, or any person, 8 minutes or more rounded up to the next quarter hour and firm, partnership, corporation, or other any time of less than 8 minutes will be disregarded. 2 The full CTT allowance will be the amount of commuted legal entity requesting Sunday, holi- traveltime prescribed for the place at which the inspections day, or overtime services of an Animal are performed. See part 97.2. One-half CTT is 1⁄2 of the full CTT period. and Plant Health Inspection Service inspector, and who has a debt to the Ani- (c) As used in this section— mal and Plant Health Inspection Serv- (1) The term private aircraft means ice more than 60 days delinquent, must any civilian aircraft not being used to transport persons or property for com- pay the inspector before service is pro- pensation or hire, and vided. (2) The term private vessel means any (2) Since the payment must be col- civilian vessel not being used (i) to lected before service can be provided, transport persons or property for com- the Animal and Plant Health Inspec- pensation or hire, or (ii) in fishing option Service inspector will estimate erations or in processing of fish or fish the amount to be paid. Any difference products. between the inspector’s estimate and (d)(1) Any principal, or any person, the actual amount owed to the Animal firm, partnership, corporation, or other and Plant Health Inspection Service legal entity acting as an agent or will be resolved as soon as reasonably broker by requesting Sunday, holiday, possible following the delivery of serv- or overtime services of an Animal and ice, with the Animal and Plant Health Plant Health Inspection Service in- Inspection Service either returning the spector on behalf of any other person, difference to the agent, broker, or prin- firm, partnership, corporation, or other cipal, or billing the agent, broker, or legal entity (principal), and who has principal for the difference. not previously requested such service (3) The prepayment must be in some from an Animal and Plant Health In- guaranteed form, such as money order, spection Service inspector, must pay certified check, or cash. Prepayment in the inspector before service is pro- guaranteed form will continue until vided. the debtor pays the delinquent debt. (2) Since the payment must be col- (4) For security reasons, cash pay- lected before service can be provided, ments will be accepted only from 7 a.m. the Animal and Plant Health Inspec- to 5 p.m., and only at a location des- tion Service inspector will estimate ignated by the Animal and Plant the amount to be paid. Any difference Health Inspection Service inspector. between the inspector’s estimate and (f) Reimbursable Sunday, holiday, or the actual amount owed to the Animal overtime services will be denied to any and Plant Health Inspection Service principal, or any person, firm, partner- will be resolved as soon as reasonably ship, corporation, or other legal entity possible following the delivery of serv- who has a debt to the Animal and ice, with the Animal and Plant Health Plant Health Inspection Service more Inspection Service either returning the than 90 days delinquent. Services will

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be denied until the delinquent debt is COMMUTED TRAVELTIME ALLOWANCES— paid. Continued [38 FR 28814, Oct. 17, 1973, as amended at 42 [In hours] FR 1455, Jan. 7, 1977; 49 FR 1176, Jan. 10, 1984; Metropolitan Area 49 FR 12191, Mar. 29, 1984; 50 FR 723, Jan. 7, Location covered Served from 1985; 52 FR 16823, May 6, 1987; 53 FR 52992, Within Outside Dec. 30, 1988; 54 FR 13516, Apr. 4, 1989; 55 FR 3198, Jan. 31, 1990; 55 FR 41059, Oct. 9, 1990; 56 Mexicali ...... Calexico ...... 1 Newport Beach ...... do ...... 4 FR 1082, Jan. 11, 1991; 58 FR 32434, June 10, Ontario ...... do ...... 3 1993; 62 FR 56025, Oct. 28, 1997; 67 FR 48523, Ramona ...... San Ysidro ...... 2 July 25, 2002; 68 FR 51882, Aug. 29, 2003] Sacramento ...... 1 ...... Do ...... San Francisco ...... 5 § 97.2 Administrative instructions pre- San Diego ...... 1 ...... scribing commuted traveltime. Do ...... San Ysidro ...... 2 San Francisco ...... 2 ...... Each period of overtime and holiday including, Ala- duty as prescribed in § 97.1 shall in ad- meda, Rich- dition include a commuted traveltime mond, Pitts- period for the respective ports, sta- burg, and other ports in tions, and areas in which employees San Fran- are located. The prescribed computed cisco and San traveltime periods are as follows: Pablo Bay areas. San Louis San Pedro ...... 6 OMMUTED RAVELTIME LLOWANCES C T A Obispo. [In hours] San Ysidro ...... 1 ...... Stockton ...... San Francisco ...... 4 Metropolitan Area Colorado: Location covered Served from Within Outside Stapleton Inter- Arvada ...... 1 ...... national Air- Alaska: port, Denver. Anchorage ...... 1 ...... Do ...... Aurora ...... 2 Do ...... Palmer ...... 3 Connecticut: Arizona: Bradley Inter- Westerly, RI ...... 5 Douglas ...... 1 ...... national Air- Do ...... Nogales ...... 6 port. Do ...... Phoenix ...... 6 Do ...... Willington ...... 1 Do ...... Sierra Vista ...... 3 Bradley Inter- Ashford ...... 1 Naco ...... Douglas ...... 2 national Air- Do ...... Nogales ...... 4 port, Windsor Do ...... Phoenix ...... 6 Locks. Do ...... Sierra Vista ...... 2 Do ...... Hartford ...... 2 ...... Nogales ...... 1 ...... Do ...... Douglas ...... 6 Do ...... N. Stonington, CT ...... 4 Do ...... Phoenix ...... 6 Do ...... Waterbury, CT ...... 3 Do ...... Sierra Vista ...... 3 Delaware: San Luis ...... Phoenix ...... 6 Wilmington ...... Dover ...... 3 Do ...... Yuma ...... 2 Florida: Sasabe ...... Douglas ...... 6 Jacksonville ...... 2 ...... Do ...... Nogales ...... 4 Miami ...... 2 ...... Do ...... Phoenix ...... 6 Port Everglades Miami ...... 2 Do ...... Sierra Vista ...... 6 St. Petersburg .. Tampa ...... 2 Do ...... Tuscon ...... 3 Do ...... Miami ...... 6 California: Tampa ...... 2 ...... Calexico ...... San Ysidro ...... 6 Do ...... Miami ...... 6 Edwards Air Los Angeles ...... 4 Georgia: Force Base. Atlanta Inter- Acworth ...... 3 Los Angeles San Bernardino ...... 5 and Los An- national Air- geles Inter- port. national Air- Do ...... Carrollton ...... 3 port. Do ...... Covington ...... 3 Do ...... Los Angeles ...... 2 ...... Do ...... Forsyth ...... 3 Los Angeles Los Angeles ...... 2 Port of Bruns- Savannah ...... 4 Harbor, San wick. Pedro, includ- Port of Savan- ...... do ...... 2 ...... ing Long nah. Beach, Wil- Port of St...... do ...... 6 mington, and Mary’s. Terminal Is- Hawaii: land. Kawaihae ...... Waimea ...... 1 March Field ...... do ...... 5 Hilo ...... do ...... 3

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COMMUTED TRAVELTIME ALLOWANCES— COMMUTED TRAVELTIME ALLOWANCES— Continued Continued [In hours] [In hours]

Metropolitan Area Metropolitan Area Location covered Served from Location covered Served from Within Outside Within Outside

Honolulu, in- ...... 2 ...... New Orleans in- ...... do ...... 4 cluding Aiea, cluding Orle- Barber’s Point ans Parish Naval Air Sta- and all points tion, Honolulu on the east International bank of the Airport, West Mississippi Loch, Middle River from the Loch, East St. Charles- Loch, Pearl Jefferson Par- City and ish boundary Waipahu. to and includ- Idaho: ing Boise ...... Caldwell or Mid- ...... 2 Chalmette, dleton. LA, and all points on the Eastport ...... Bonners Ferry ...... 2 west bank Do ...... Spokane, WA ...... 6 from the St. Illinois: Charles-Jef- Chicago ...... 3 ...... ferson Parish Do ...... Geneseo ...... 6 boundary to Do ...... Kirkland ...... 4 but excluding Springfield ...... 2 ...... Belle Chasse, Indiana: LA. Indianapolis ...... 1 ...... Undesignated ...... do ...... 3 ports. Do ...... Anderson ...... 2 Maine: Do ...... West Lafayette ...... 3 Bangor ...... Augusta ...... 3 Iowa: Do ...... Newport ...... 1 Ames ...... 1 ...... Houlton ...... 1 ...... Kentucky: Jackman ...... Augusta ...... 6 Standiford Field Frankfort ...... 3 Do ...... Bangor ...... 5 Do ...... Louisville ...... 1 ...... Do ...... Newport ...... 5 Louisiana: Port of Portland Augusta ...... 3 Acadian Re- Abbeville ...... 2 Do ...... Bangor ...... 6 gional Airport, Do ...... Concord, NH ...... 4 New Iberia. Maryland: Any point below Baton Rouge ...... 4 Baltimore: ...... 3 ...... Chalmette Largo ...... Bowie ...... 2 ...... and on the Do ...... Owings Mills ...... 3 ...... East Bank, Do ...... Easton ...... 4 Belle Chasse, Laurel ...... Bowie ...... 2 ...... LA, and Do ...... Owings Mills ...... 3 ...... points to and Do ...... Easton ...... 4 including Port Massachusetts: Sulphur on Boston ...... 3 ...... the west bank. Do ...... Grafton ...... 4 Any point on the ...... do ...... 2 Do ...... Loudon, NH ...... 5 Mississippi Do ...... N. Attleboro ...... 4 River above Do ...... Westerly, RI ...... 4 the St. Mexico: 1 Charles-Jef- Ciudad Acuna .. Del Rio, TX ...... 1 ⁄2 ferson Parish Do ...... Eagle Pass, TX ...... 3 boundary to Do ...... Laredo, TX ...... 6 and including Do ...... Pleasanton, TX ...... 6 Gramercy. Juarez ...... El Paso, TX ...... 1 Morgan City ...... do ...... 5 Nuevo Laredo .. Del Rio, TX ...... 4 Do ...... Eagle Pass, TX ...... 5 Do ...... Laredo, TX ...... 11⁄2 Do ...... Pharr, TX ...... 6 Do ...... Pleasanton, TX ...... 5 Ojinaga ...... El Paso, TX ...... 6 Do ...... Presidio, TX ...... 1 Piedras Negras Eagle Pass, TX ...... 1 Do ...... Laredo, TX ...... 5 Do ...... Pharr, TX ...... 10 Do ...... Pleasanton, TX ...... 5

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COMMUTED TRAVELTIME ALLOWANCES— COMMUTED TRAVELTIME ALLOWANCES— Continued Continued [In hours] [In hours]

Metropolitan Area Metropolitan Area Location covered Served from Location covered Served from Within Outside Within Outside

Reynosa (Pharr Eagle Pass, TX ...... 12 Port of Salem ... Hightstown ...... 31⁄2 ...... International Do ...... Mount Holly ...... 3 ...... Bridge). Do ...... Princeton ...... 4 ...... Do ...... Hidalgo, TX ...... 1 New Mexico: Do ...... Laredo, TX ...... 5 Columbus ...... 1 ...... Do ...... Mission, TX ...... 1 Do ...... Las Cruces ...... 4 Do ...... Pharr, TX ...... 1 Port of Colum- Deming ...... 2 San Jeronimo ... El Paso, TX ...... 2 bus. Do ...... Presidio, TX ...... 6 New York: Do ...... Santa Theresa, ...... 1 Alexandria Bay ...... 1 ...... NM. Buffalo ...... 2 ...... Michigan: Do ...... Akron ...... 2 Detroit ...... 3 ...... Champlain ...... 1 ...... Do ...... Beaverton ...... 6 Do ...... Highgate Springs, ...... 2 Do ...... Chelsea ...... 3 VT. Do ...... Clara ...... 6 Do ...... Milton, VT ...... 3 Do ...... Kalamazoo ...... 5 Do ...... Calais, VT ...... 5 Do ...... Lansing ...... 4 Malone ...... Champlain ...... 3 Do ...... Port Huran ...... 4 Newburgh ...... 1 ...... Port Huron ...... 1 ...... Do ...... New York, NY ...... 4 Do ...... Beaverton ...... 6 New York ...... 3 ...... Do ...... Chelsea ...... 6 Niagara Falls .... Akron ...... 2 Do ...... Clara ...... 6 Odgensburg ...... 1 ...... Do ...... Detroit ...... 3 Port of Albany ...... 1 ...... Do ...... Lansing ...... 5 Rochester ...... Buffalo ...... 4 Do ...... Kalamazoo ...... 6 Rooseveltown .. Odgensburg ...... 2 Minnesota: Rouses Point ... Champlain ...... 1 Minneapolis/St...... 2 ...... Stewart Airport, Albany ...... 4 Paul Inter- Newburgh. national Air- North Carolina: port. Iredell ...... Franklin ...... 6 Do ...... Rochester ...... 3 Do ...... Lumberton ...... 6 Do ...... Princeton ...... 3 Do ...... Raleigh ...... 6 Noyes ...... Pembina ...... 1 North Dakota: Missouri: Dunseith ...... Minot ...... 4 Kansas City Jefferson ...... 6 Do ...... Pembina ...... 6 International Minot ...... 1 ...... Airport. Peace Gardens Bottineau ...... 1 St. Louis Airport Beaufort ...... 3 Pembina ...... 1 ...... St. Louis Zoo- ...... do ...... 3 Do ...... Fargo ...... 6 logical Park. Do ...... Valley City ...... 6 Montana: Portal ...... 1 ...... Bozeman ...... 1 ...... Do ...... Bismarck ...... 6 Bozeman Lab- Bozeman ...... 1 ...... Do ...... Dickinson ...... 6 oratory. Do ...... Minot ...... 4 Great Falls Air- Great Falls ...... 1 ...... Ohio: port. Vandalia Dayton Greenville ...... 2 Do ...... Helena ...... 5 International Helena ...... 1 ...... Airport. Port of Opheim Plentywood ...... 5 Do ...... Pickerington ...... 3 Do ...... Opheim ...... 1 Wilmington ...... Greenville ...... 4 Port of Ray- Plentywood ...... 1 ...... Do ...... Pickerington ...... 3 mond. Oregon: Do ...... Raymond ...... 1 Hermiston ...... Troutdale ...... 6 Port of Great Falls ...... 5 Portland ...... Salem ...... 3 Sweetgrass. Do ...... Sunny Valley ...... 6 Do ...... Shelby ...... 2 Do ...... Tigard ...... 2 ...... Do ...... Sunburst/ 1 ...... Do ...... Troutdale ...... 2 ...... Sweetgrass. Pennsylvania: Sweetgrass ...... 1 ...... Harrisburg ...... Camp Hill ...... 1 ...... Nebraska: Do ...... Morgantown ...... 3 Lincoln Airport ...... 1 ...... Do ...... Northumberland ...... 2 New Jersey: Do ...... Shippensburg ...... 3 Newark Inter- Hightstown ...... 2 ...... Philadelphia ...... 3 ...... national Air- Puerto Rico: port. Aquadilla ...... Aquadilla ...... 2 Do ...... Mount Holly ...... 3 ...... Salinas ...... San Juan ...... 4 Do ...... Princeton ...... 2 ...... San Juan ...... 2 ......

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COMMUTED TRAVELTIME ALLOWANCES— COMMUTED TRAVELTIME ALLOWANCES— Continued Continued [In hours] [In hours]

Metropolitan Area Metropolitan Area Location covered Served from Location covered Served from Within Outside Within Outside

Tennessee: Do ...... McAllen, Edinburg ...... 6 Fort Campbell, Nashville ...... 2 or Mission. Clarkesville. Presidio ...... 1 ...... Memphis ...... 2 ...... Do ...... El Paso ...... 6 Memphis ...... Gadsden ...... 4 Utah: Memphis ...... Jackson ...... 4 Nashville ...... 2 ...... Salt Lake City .. Murray and 2 ...... Ogden. Texas: Brownsville ...... 1 ...... Vermont: Do ...... Laredo or San An- ...... 6 Burlington Inter- Burlington ...... 1 ...... tonio. national Air- Brownsville and Harlingen and San ...... 1 port. Brownsville Benito. Do ...... Milton ...... 1 International Do ...... Calais ...... 3 Airport. Derby Line ...... Milton ...... 4 Do ...... McAllen or Edin- ...... 3 Do ...... Calais ...... 4 burg. Highgate ...... 1 ...... Do ...... Weslaco ...... 2 Dallas-Forth Decatur ...... 2 Do ...... Milton ...... 2 Worth Inter- Do ...... Calais ...... 4 national Air- Highgate ...... do ...... 1 port. Springs. Do ...... Ft. Worth or Dal- ...... 2 Virginia: las. Dulles Inter- Annapolis, MD ..... 3 ...... Del Rio ...... 1 ...... national Air- Do ...... Eagle Pass ...... 3 port. Do ...... Edinburg, McAllen ...... 6 Do ...... Richmond ...... 5 or Mission. Do ...... Warrenton ...... 3 Do ...... Laredo or San An- ...... 5 Port of Rich- ...... 2 ...... tonio. mond. Eagle Pass ...... 1 ...... Washington: Do ...... Del Rio ...... 3 Do ...... Edinburgh, ...... 6 Blaine ...... 1 ...... McAllen or Mis- Do ...... Seattle ...... 6 sion. Lynden ...... Blaine ...... 2 Do ...... Laredo or San An- ...... 5 Do ...... Seattle ...... 6 tonio. Moses Lake ..... Oroville, WA ...... 6 El Paso ...... 1 ...... Do ...... Spokane ...... 5 Do ...... Hatchita or ...... 6 Do ...... Wenatchee ...... 3 Deming, NM. Do ...... Las Cruces, NM ...... 3 Do ...... Yakima ...... 4 Forney ...... Corsicana ...... 3 Oroville ...... 1 ...... Do ...... Ft. Worth ...... 3 Sea-Tac Airport Olympia ...... 3 Do ...... Tyler ...... 3 Seattle ...... 2 ...... Harlingen ...... Edinburg, McAllen ...... 2 Sumas ...... Blaine ...... 2 or Mission. Do ...... Olympia ...... 6 Do ...... Weslaco ...... 1 Do ...... Seattle ...... 6 Hidalgo ...... Brownsville ...... 3 Tacoma ...... do ...... 3 Do ...... Edinburg, Mission ...... 1 and McAllen. Yelm ...... Olympia ...... 2 Do ...... Harlingen ...... 2 Do ...... Seattle ...... 3 Do ...... Lyford ...... 2 Wisconsin: Do ...... Rio Grande City ...... 2 Barron ...... Ripon ...... 6 Houston (includ- ...... 2 Madison ...... 1 ...... ing Houston Monroe ...... Madison ...... 3 Interconti- nental Airport). Do ...... Bellville, TX ...... 4 [39 FR 41356, Nov. 27, 1974] Do ...... Bryan, TX ...... 4 Do ...... Georgetown, TX ...... 8 EDITORIAL NOTE: For FEDERAL REGISTER ci- Do ...... Pleasanton, TX ...... 8 tations affecting § 97.2, see the List of CFR Laredo ...... 1 ...... Sections Affected, which appears in the Do ...... Brownsville or San ...... 6 Finding Aids section of the printed volume Antonio. Do ...... Eagle Pass ...... 5 and at www.fdsys.gov.

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PART 98—IMPORTATION OF CER- AUTHORITY: 7 U.S.C. 1622 and 8301–8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, TAIN ANIMAL EMBRYOS AND 2.80, and 371.4. ANIMAL SEMEN § 98.1 Prohibition. Sec. 98.1 Prohibition. An embryo shall not be imported or entered into the United States unless Subpart A—Ruminant and Swine Embryos in accordance with the provisions of from Regions Free of Rinderpest and this part. Foot-and-Mouth Disease; and Embryos [50 FR 43563, Oct. 25, 1985. Redesignated at 56 of Horses and Asses FR 58808, Oct. 30, 1991] 98.2 Definitions. 98.3 General conditions. Subpart A—Ruminant and Swine 98.4 Import permit. Embryos from Regions Free of 98.5 Health certificate. 98.6 Ports of entry. Rinderpest and Foot-and- 98.7 Declaration upon arrival. Mouth Disease; and Embryos 98.8 Inspection. of Horses and Asses 98.9 Embryos refused entry. 98.10 Other importations. § 98.2 Definitions. 98.10a Embryos from sheep in regions other than Australia, Canada, and New Zea- The following terms, when used in land. this subpart, shall be construed as defined. Those terms used in the singular Subpart B—Ruminant and Swine Embryos form in this subpart shall be construed from Regions Where Rinderpest or as the plural form and vice versa, as Foot-and-Mouth Disease Exists the case may demand. 98.11 Definitions. Administrator. The Administrator, 98.12 General prohibitions. Animal and Plant Health Inspection 98.13 Import permit. Service, or any person authorized to 98.14 Health certificate. act for the Administrator. 98.15 Health requirements. Animal. Any cattle, sheep, goats, 98.16 The embryo collection unit. other ruminants, swine, horses, or 98.17 Procedures. asses. 98.18 Shipment of embryos to the United Animal and Plant Health Inspection States. 98.19 Arrival and inspection at the port of Service. The Animal and Plant Health entry. Inspection Service of the United States 98.20 Embryos refused entry. Department of Agriculture (APHIS). 98.21 Embryos from sheep in regions other Approved artificial insemination center. than Australia, Canada, and New Zea- A facility approved or licensed by the land. national government of the region in which the facility is located to collect Subpart C—Certain Animal Semen and process semen under the general 98.30 Definitions. supervision of such government. 98.31 General prohibitions; exceptions. Approved embryo transfer unit. A facil- 98.32 Inspection of certain aircraft and ity approved or licensed by the na- other means of conveyance and shipping tional government of the region in containers thereon; unloading, cleaning, and disinfection requirements. which the facility is located for the ar- 98.33 Ports designated for the importation tificial insemination of donor dams or of certain animal semen. for conception as a result of artificial 98.34 Import permits for poultry semen and breeding by a donor sire and for col- animal semen. lecting and processing embryos for ex- 98.35 Declaration, health certificate, and port under the general supervision of other documents for animal semen. such government. 98.36 Animal semen from Canada. Department. The United States De- 98.37 [Reserved] 98.38 Restrictions on the importation of partment of Agriculture. swine semen from the APHIS-defined Eu- Embryo. The initial stage of an ani- ropean CSF region. mal’s development after collection

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from the natural mother, while it is ca- rinderpest and foot-and-mouth disease, pable of being transferred to a recipi- and: ent dam, but not including an embryo (a) The embryo is exported to the that has been transferred to a recipient United States from the region in which dam. it was conceived; Enter (entered, entry) into the United (b) The embryo was conceived as a re- States. To introduce into the commerce sult of artificial insemination with of the United States after release from semen collected from a donor sire at an governmental detention at the port of approved artificial insemination cen- entry. ter, or the embryo as conceived as a re- Flock. A herd. sult of natural breeding by a donor sire Herd. All animals maintained on any at an approved embryo transfer unit; single premises; and all animals under (c) If artificially inseminated, the common ownership or supervision on donor dam conceived the embryo after two or more premises which are geo- being inseminated in an approved em- graphically separated, but among bryo transfer unit with semen collected which there is an interchange or move- at an approved artificial insemination ment of animals. center; Import (imported, importation) into the (d) At the time of collection of the United States. To bring into the terri- semen used to conceive the embryo or torial limits of the United States. at the time of natural breeding, the Inspector. An employee of APHIS who donor sire met all requirements the is authorized to perform the function donor sire would have to meet under involved. part 93 of this chapter for a health cer- Person. Any individual, corporation, tificate required as a condition of im- company, association, firm, partner- portation into the United States; ship, society, joint stock company, or (e) At the time of collection of the any other legal entity. embryo from the donor dam, the donor Region. Any defined geographic land dam met all requirements the donor area identifiable by geological, polit- dam would have to meet under part 92 ical, or surveyed boundaries. A region of this chapter for a health certificate may consist of any of the following: required as a condition of importation into the United States; (1) A national entity (country); (f) There is no basis for denying an (2) Part of a national entity (zone, import permit for the donor sire or county, department, municipality, par- donor dam under § 93.304(a)(2) for ish, Province, State, etc.) horses, § 93.404(a)(2) or (3) for (3) Parts of several national entities ruminants, and § 93.504(a)(2) or (3) for combined into an area; or swine of this chapter; (4) A group of national entities (coun- (g) The embryo is collected and tries) combined into a single area. maintained under conditions deter- United States. All of the several mined by the Administrator to be ade- States of the United States, the Dis- quate to protect against contamination trict of Columbia, Guam, the Northern of the embryo with infectious animal Mariana Islands, Puerto Rico, the Vir- disease organisms; and gin Islands of the United States and all (h) The embryo was determined, other territories and possessions of the based on microscopic examination, to United States. have an intact zona pellucida at the [50 FR 43563, Oct. 25, 1985. Redesignated and time the embryo was placed into its amended at 56 FR 55808, Oct. 30, 1991; 57 FR immediate container (straw or ampule) 29194, July 1, 1992; 61 FR 17241, Apr. 19, 1996; for shipping. 62 FR 56025, Oct. 28, 1997] (i) The embryo is contained in a shipping container which at the time of § 98.3 General conditions. offer for entry is sealed with an official Except as provided in subpart B of seal which was affixed to the shipping this part, an animal embryo shall not container by a full-time salaried vet- be imported into the United States un- erinarian of the national animal health less it is from a region listed under service of the region of origin or by a § 94.1(a) of this chapter as being free of veterinarian authorized to do so by the

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national animal health service of the pear to be eligible to be imported. Even region of origin. though an import permit has been [50 FR 43563, Oct. 25, 1985, as amended at 55 issued for the importation of an em- FR 31558, Aug. 2, 1990; 56 FR 55809, Oct. 30, bryo, the embryo may be imported 1991; 57 FR 29194, July 1, 1992; 62 FR 56025, only if all applicable requirements of Oct. 28, 1997; 77 FR 1396, Jan. 10, 2012] this subpart are met.

§ 98.4 Import permit. [50 FR 43563, Oct. 25, 1985, as amended at 56 FR 55809, Oct. 30, 1991; 57 FR 29194, July 1, (a) Except as provided in subpart B of 1992; 59 FR 67616, Dec. 30, 1994; 62 FR 56025, this part, an animal embryo shall not Oct. 28, 1997] be imported into the United States unless accompanied by an import permit § 98.5 Health certificate. issued by APHIS and unless imported (a) Except as provided in subpart B of into the United States within 14 days this part, an animal embryo shall not after the proposed date of arrival stat- be imported into the United States un- ed in the import permit. (b) An application for an import per- less it is accompanied by a certificate mit must be submitted to the Animal issued by a full-time salaried veteri- and Plant Health Inspection Service, nary officer of the national govern- Veterinary Services, National Center ment of the region of origin, or issued for Import-Export, 4700 River Road by a veterinarian designated or accred- Unit 38, Riverdale, Maryland 20737–1231. ited by the national government of the An application form for an import per- region of origin and endorsed by a full- mit may be obtained from this staff. time salaried veterinary officer of the (c) The completed application shall national government of the region of include the following information: origin, representing that the veteri- (1) The name and address of the per- narian issuing the certificate was au- son intending to export an embryo thorized to do so. The certificate shall from the region of origin, state: (2) The name and address of the per- (1) The dates, places, types, and re- son intending to import an embryo, sults of all examinations and tests per- (3) The species, breed, and number of formed on the donor sire and donor embryos to be imported, dam as a condition for importation of (4) The purpose of the importation, the embryo, and the names and ad- (5) The region in which the embryo is dresses of persons or laboratories con- conceived, ducting the examinations or tests, and (6) The port of embarkation, a statement that any other require- (7) The mode of transportation, ments established by § 98.3 have been (8) The route of travel, complied with, (9) The port of entry in the United (2) The name and address of the con- States, signor and consignee, (10) The proposed date of arrival in (3) The name and address of the ap- the United States, proved artificial insemination center (11) The name and address of the per- where the semen for the embryo was son to whom the embryo will be deliv- collected, if applicable, ered in the United States, and (12) The measures to be taken to en- (4) The name and address of the ap- sure that the embryo is collected and proved embryo transfer unit where the maintained under conditions adequate donor dam was inseminated or bred and to protect against contamination of the embryo was collected, and the embryo with infectious animal dis- (5) The measures taken to ensure ease organisms. that the embryo was collected and (d) After receipt and review of the ap- maintained under conditions adequate plication by APHIS, an import permit to protect against contamination of indicating the applicable conditions the embryo with infectious animal dis- under this subpart for importation into ease organisms. the United States shall be issued for (b) The certificate accompanying the importation of embryos described sheep or goat embryos intended for im- in the application if such embryos ap- portation from any part of the world

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shall, in addition to the statements re- (i) The name and address of the per- quired by paragraph (a) of this section, son to whom the embryo will be deliv- state that: ered. (1) The embryos’ sire and dam have [50 FR 43563, Oct. 25, 1985, as amended at 57 not been in any flock or herd nor had FR 29194, July 1, 1992; 62 FR 56025, Oct. 28, contact with sheep or goats which have 1997] been in any flock or herd where scrapie has been diagnosed or suspected during § 98.8 Inspection. the 5 years prior to the date of collec- Any embryo offered for entry into tion of the embryos; the United States in accordance with (2) The embryos’ sire and dam showed this subpart and documents accom- no evidence of scrapie at the time the panying the embryo shall be subject to embryos were collected; inspection by an inspector at the time the embryo is offered for entry in order (3) Scrapie has not been suspected to determine whether the embryo is el- nor confirmed in any progeny of the igible for entry. The import permit and embryos’ donor dam; and the health certificate shall be given to (4) The parents of the embryos’ sire the inspector. and dam are not, nor were not, affected with scrapie. [50 FR 43563, Oct. 25, 1985, as amended at 56 FR 55809, Oct. 30, 1991] (Approved by the Office of Management and Budget under control number 0579–0040) § 98.9 Embryos refused entry. [50 FR 43563, Oct. 25, 1985, as amended at 56 Any embryo refused entry into the FR 55809, Oct. 30, 1991; 61 FR 15183, Apr. 5, United States for noncompliance with 1996; 61 FR 17241, Apr. 19, 1996; 62 FR 56025, the requirements of this subpart shall Oct. 28, 1997] be removed from the United States within a time period specified by the § 98.6 Ports of entry. Administrator or abandoned by the importer for destruction, and pending An embryo shall not be imported into such action shall be subject to such the United States unless at a port of safeguards as the inspector determines entry listed in § 93.303 for horses, § 93.403 necessary to prevent the possible intro- for ruminants, or § 93.503 for swine of duction into the United States of infec- this chapter. tious animal diseases. If such embryo [50 FR 43563, Oct. 25, 1985, as amended at 55 is not removed from the United States FR 31558, Aug. 2, 1990; 62 FR 56025, Oct. 28, within such time period, or abandoned 1997] for destruction, it may be seized, destroyed, or otherwise disposed of as the § 98.7 Declaration upon arrival. inspector determines necessary to pre- Upon arrival of an embryo at a port vent the possible introduction into the United States of infectious animal dis- of entry, the importer or the import- eases. er’s agent shall notify APHIS of the arrival by giving an inspector a docu- [50 FR 43563, Oct. 25, 1985, as amended at 56 ment stating: FR 55809, Oct. 30, 1991; 57 FR 29194, July 1, (a) The port of entry, 1992] (b) The date of arrival, § 98.10 Other importations. (c) Import permit number, Notwithstanding other provisions in (d) Carrier, and identification of the this part, the Administrator may in means of conveyance, specific cases allow the importation (e) The name and address of the im- and entry into the United States of em- porter, bryos other than as provided for in this (f) The name and address of the part under such conditions as the Ad- broker, ministrator may prescribe to prevent (g) The region of origin of the em- the introduction into the United States bryo, of infectious animal diseases. (h) The number, species, and purpose [50 FR 43563, Oct. 25, 1985, as amended at 57 of importation of the embryo, and FR 29194, July 1, 1992]

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§ 98.10a Embryos from sheep in re- and sire whose flock in the region of gions other than Australia, Canada, origin participates in a program deter- and New Zealand. mined by the Administrator to be (a) Except for embryos from sheep in equivalent to the Voluntary Scrapie Australia, Canada, or New Zealand, Flock Certification Program, then the embryos from sheep may only be im- embryos may be placed in a flock in ported into the United States if they the United States which would be clas- comply with all applicable provisions sified at a level equivalent to or lower of this subpart and one of the following (i.e., at a greater risk) than the certifi- conditions: cation level, as determined by the Ad- (1) The embryos are transferred to fe- ministrator, of either the flock of the males in a flock in the United States dam or the flock of the sire, whichever that participates in the Voluntary one presents the greater risk. Scrapie Flock Certification Program (e) The flock to which the sheep em- (see 9 CFR part 54, subpart B) and bryos are transferred pursuant to para- qualifies as a ‘‘Certified’’ flock; or graph (a)(2) of this section must be (2) The embryos are transferred to fe- monitored for scrapie disease until the males in a flock in the United States flock, and all first generation progeny that participates in the Voluntary resulting from the embryos imported Scrapie Flock Certification Program in accordance with this section, quali- (see 9 CFR part 54, subpart B) and the fies as a ‘‘Certified’’ flock. flock owner has agreed, in writing, to (f) Except for sheep embryos being maintain the flock, and all first gen- placed in Certifiable Class C flocks, the eration progeny resulting from em- certificate accompanying sheep embryos imported in accordance with this bryos imported under paragraph (a) of section, in compliance with all require- this section must contain the following ments of the Voluntary Scrapie Flock statement: ‘‘The embryos identified on Certification Program until the flock, this certificate are the progeny of a including all first generation progeny dam and sire that have been monitored resulting from embryos imported in ac- by a salaried veterinary officer of cordance with this section, qualifies as [name of region of origin], for [number of a ‘‘Certified’’ flock. months], in the same source flock which (b) Sheep embryos may be imported had been determined by the Adminis- under paragraph (a) of this section only trator, APHIS, prior to the exportation if the importer provides the Voluntary of these embryos to the United States, Scrapie Flock Certification Program to be equivalent to [certification level (of identification number of the receiving dam or sire) presenting greater risk] of flock as part of the application for an the Voluntary Scrapie Flock Certifi- import permit. (c) Sheep embryos may be imported cation Program authorized under 9 under paragraph (a)(1) of this section CFR part 54, subpart B.’’ only if they are the progeny of a dam (1) The Administrator will determine, and sire that are part of flocks in the based upon information supplied by the region of origin that participate in a importer, whether the flock of the em- program determined by the Adminis- bryos’ dam and sire participates in a trator to be equivalent to the Vol- program in the region of origin that is untary Scrapie Flock Certification equivalent to the Voluntary Scrapie Program, and the flocks have been de- Flock Certification Program, and if so, termined by the Administrator to be at at what level the source flock would be a level equivalent to ‘‘Certified’’ in the classified. Voluntary Scrapie Flock Certification (2) In order for the Administrator to Program. make a determination, the importer (d) Sheep embryos may be imported must supply the following information under paragraph (a)(2) of this section with the application for an import per- only if they are transferred to animals mit, no less than 1 month prior to the in a Certifiable Class C flock partici- anticipated date of importation: pating in the Voluntary Scrapie Flock (i) The name, title, and address of a Certification Program; except, that if knowledgeable official in the veteri- the embryos are the progeny of a dam nary services of the region of origin;

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(ii) The details of scrapie control pro- Embryo. The initial stages of develop- grams in the region of origin, including ment of an animal, after collection information on disease surveillance from the natural mother and while it is and border control activities and the capable of being transferred to a recipi- length of time such activities have ent dam, but not after it has been been in effect; transferred to a recipient dam. (iii) Any available information con- Embryo collection unit. Area or areas cerning additions, within the 5 years where the donor dam will be bred to immediately preceding collection of produce embryos for importation into the embryos, to the flock of the em- the United States, and where the embryos’ sire and dam; bryos will be collected, processed, and (iv) Any available data concerning stored pending shipment to the United disease incidence, within the 5 years States. immediately preceding collection of Foreign Animal Disease Diagnostic Lab- the embryos, in the flock of the em- oratory. The Foreign Animal Disease bryos’ sire and dam, including, but not Diagnostic Laboratory of the Animal limited to, the results of diagnostic and Plant Health Inspection Service. tests, especially histopathology tests, Herd of origin. The herd in which the conducted on any animals in the flock; donor dam is kept during the 60 days (v) Information concerning the before the donor dam is required to be health, within the 5 years immediately housed in an embryo collection unit, in preceding collection of the embryos, of accordance with § 98.17(a) of this sub- other ruminants, flocks, and herds part. with which the embryos’ sire and dam Import. To bring into the territorial and the flock of the embryos’ sire and limits of the United States. dam might have had physical contact, Inspector. An employee of the Animal and a description of the type and fre- and Plant Health Inspection Service quency of the physical contact; and who is authorized to perform the func- (vi) Any other information requested tion involved. by the Administrator in specific cases Official veterinarian. A full-time sala- as needed to make a determination. ried veterinarian of the national gov- (g) All first generation progeny re- ernment of the country of origin or a sulting from embryos imported under veterinarian employed by the Animal this section are subject to the require- and Plant Health Inspection Service ments of 9 CFR part 54 and all other (APHIS), and designated by APHIS to applicable regulations. supervise or conduct procedures re- (Approved by the Office of Management and quired by this subpart, and to certify Budget under control numbers 0579–0040 and that requirements of this subpart have 0579–0101) been met. [61 FR 17241, Apr. 19, 1996, as amended at 62 Person. Any individual, corporation, FR 56025, Oct. 28, 1997] company, association, firm, partnership, society, joint stock company, or other legal entity. Subpart B—Ruminant and Swine Region. Any defined geographic land Embryos From Regions Where area identifiable by geological, polit- Rinderpest or Foot-and-Mouth ical, or surveyed boundaries. A region Disease Exists may consist of any of the following: (1) A national entity (country); SOURCE: 56 FR 55809, Oct. 30, 1991, unless (2) Part of a national entity (zone, otherwise noted. county, department, municipality, parish, Province, State, etc.); § 98.11 Definitions. (3) Parts of several national entities Animal and Plant Health Inspection combined into an area; or Service. The Animal and Plant Health (4) A group of national entities (coun- Inspection Service of the United States tries) combined into a single area. Department of Agriculture. Region of origin. The region in which Collection of embryos. Embryos re- the embryo is conceived and collected moved from a single donor dam in one and from which the embryo is imported operation. into the United States.

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Ruminant. All animals which chew (3) The name and address of the place the cud, including cattle, buffaloes, where the donor dam will be bred and camelids, cervids (deer, elk, moose, and where the embryo(s) will be collected; antelope), sheep, goats, and giraffes. (4) The species, breed, and number of Swine. The domestic hog and all vari- embryos to be imported; eties of wild hogs. (5) The purpose of the importation; United States. All of the States of the (6) The port of embarkation; United States, the District of Colum- (7) The mode of transportation; bia, Guam, the Northern Mariana Is- (8) The route of travel; lands, Puerto Rico, the Virgin Islands (9) The port of entry in the United of the United States, and all other ter- States; ritories and possessions of the United (10) The proposed date of arrival in States. the United States; and (11) The name and address of the per- [56 FR 55809, Oct. 30, 1991, as amended at 61 FR 15183, Apr. 5, 1996; 62 FR 56025, Oct. 28, son to whom the embryos will be deliv- 1997] ered in the United States. (Approved by the Office of Management and § 98.12 General prohibitions. Budget under control number 0579–0040) (a) Ruminant and swine embryos [56 FR 55809, Oct. 30, 1991, as amended at 59 may not be imported from regions FR 67616, Dec. 30, 1994; 61 FR 15183, Apr. 5, where rinderpest or foot-and-mouth 1996; 62 FR 56025, Oct. 28, 1997] disease exists except in accordance with this subpart. § 98.14 Health certificate. (b) Ruminant and swine embryos (a) Ruminant and swine embryos may not be imported into the United shall not be imported into the United States from any region other than the States unless they are accompanied by region in which they were conceived a certificate issued by a full-time sala- and collected. ried veterinary officer of the national [56 FR 55809, Oct. 30, 1991, as amended at 61 government of the region of origin, or FR 15183, Apr. 5, 1996; 62 FR 56025, Oct. 28, issued by a veterinarian designated or 1997] accredited by the national government of the region of origin and endorsed by § 98.13 Import permit. a full-time salaried veterinary officer (a) Ruminant and swine embryos and of the national government of the re- all test samples required by this sub- gion of origin, representing that the part may be imported into the United veterinarian issuing the certificate was States from regions where foot-and- authorized to do so. mouth disease or rinderpest exists only (b) The health certificate must state: if accompanied by import permits (1) The name and address of the place issued by the Animal and Plant Health where the embryos were collected; Inspection Service (APHIS). (2) The name and address of the (b) An application for the import per- vetrinarian who collected the embryos; mits must be submitted to the Animal (3) The date of embryo collection; and Plant Health Inspection Service, (4) The identification and breed of Veterinary Services, National Center the donor dam and donor sire; for Import-Export, 4700 River Road (5) The number of ampules or straws Unit 38, Riverdale, Maryland 20737–1231. covered by the health certificate and Application forms also may be ob- the identification number or code on tained at this same address. The appli- each ampule or straw; cation for a permit to import embryos (6) The dates, types, and results of all will also serve as the application for a examinations and tests performed on permit to import test samples for those the donor dam and donor sire as a con- embryos; separate applications are not dition for importing the embryos; required. The application must include (7) The dates and results of all tests the following information: performed on unfertilized eggs, (1) The name and address of the ex- nontransferrable embryos, and embryo porter; collection and wash fluids; (2) The name and address of the im- (8) The names and addresses of the porter; consignor and consignee;

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(9) That the embryos are being im- ease, Rift Valley fever, rinderpest, or ported into the United States in ac- vesicular stomatitis; or cordance with subpart B of 9 CFR part (ii) Swine: African swine fever, foot- 98. and-mouth disease, classical swine (c) If any of the information required fever, pseudorabies, rinderpest, swine by paragraph (b) of this section is pro- vesicular disease, or vesicular stoma- vided in code, deciphering information titis. must be attached to the health certifi- (2) During the year before embryo cate. collection, no case of the following dis- (d) The health certificate accom- eases occurred within 5 kilometers of panying sheep or goat embryos in- the embryo collection unit or in any tended for importation from any part herd in which the donor dam was of the world shall, in addition to the present: statements required by paragraph (b) of this section, state that: (i) Ruminant: Bovine spongiform (1) The embryos’ sire and dam have encephalopathy, contagious bovine not been in any flock or herd nor had pleuropneumonia, foot-and-mouth dis- contact with sheep or goats which have ease, Rift Valley fever, rinderpest, or been in any flock or herd where scrapie vesicular stomatitis; or has been diagnosed or suspected during (ii) Swine: African swine fever, foot- the 5 years prior to the date of collec- and-mouth disease, classical swine tion of the embryos; fever, pseudorabies, rinderpest, swine (2) The embryos’ sire and dam showed vesicular disease, or vesicular stoma- no evidence of scrapie at the time the titis. embryos were collected; (3) During the 60 days before embryo (3) Scrapie has not been suspected collection, the donor dam did not re- nor confirmed in any progeny of the ceive a vaccination for either rinder- embryos’ donor dam; and pest or foot-and-mouth disease. (4) The parents of the embryos’ sire (4) During the 60 days before the and dam are not, nor were not, affected donor dam was required to be in the with scrapie. embryo collection unit, in accordance (e) There must be a separate health with § 98.17(a) of this subpart, the donor certificate for each collection of em- dam remained in the same herd, and no bryos. ruminants or swine were added to that (Approved by the Office of Management and herd. Budget under control number 0579–0040) (5)(i) On the day of embryo collec- [56 FR 55809, Oct. 30, 1991, as amended at 61 tion, and again not less than 30 days FR 15183, Apr. 5, 1996; 61 FR 17242, Apr. 19, nor more than 120 days afterward, one 1996; 62 FR 56025, Oct. 28, 1997] sample of at least 10 ml of serum was collected from the donor dam, frozen, § 98.15 Health requirements. and sent to the Foreign Animal Disease Ruminant and swine embryos may be Diagnostic Laboratory for testing. imported from a region where rinder- (ii) The donor dam was determined to pest or foot-and-mouth disease exists be free of foot-and-mouth disease based only if all of the following conditions upon tests of the pair of serum sam- are met: ples. In addition, if any of the following (a) The donor dam is determined to diseases exist in the region of origin, be free of communicable diseases based the donor dam was determined to be on tests, and examinations, and other free of these diseases based upon addi- requirements, as follows: tional tests of the serum samples: (1) During the year before embryo collection, no case of the following dis- (A) Ruminant: Contagious bovine eases occurred in the embryo collec- pleuropneumonia, Rift Valley fever, tion unit or in any herd in which the rinderpest, or vesicular stomatitis; or donor dam was present: (B) Swine: African swine fever, clas- (i) Ruminant: Bovine spongiform sical swine fever, pseudorabies, rinder- encephalopathy, contagious bovine pest, swine vesicular disease, or vesic- pleuropneumonia, foot-and-mouth dis- ular stomatitis.

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(iii) If the donor dam was in any herd (B) Swine: African swine fever, bru- during the year before embryo collec- cellosis, foot-and-mouth disease, clas- tion that was not certified free of bru- sical swine fever, pseudorabies, rinder- cellosis by the national government of pest, swine vesicular disease, tuber- the region of origin, the donor dam was culosis, and vesicular stomatitis. determined to be free of brucellosis (ii) All signs of any other commu- based on tests of the serum samples. nicable disease must be listed on the (iv) The only official test results will health certificate that accompanies be those provided by the Foreign Ani- the embryos to the United States. mal Disease Diagnostic Laboratory. (b) The donor dam or donor sire is de- (6) If the donor dam was in any herd termined to be free of communicable during the year before embryo collec- diseases based on other testing or cer- tion that was not certified free of tu- tifications if required by the Adminis- berculosis by the national government trator. The Administrator may require of the region of origin, the donor dam additional testing or certifications if was determined to be free of tuber- he or she determines that they are nec- culosis by an official veterinarian essary to determine either the donor based on an intradermal tuberculin dam’s or the donor sire’s freedom from test. The test must have been adminis- communicable diseases. Circumstances tered to the donor dam by an official that may result in additional testing veterinarian not less than 30 days nor or certifications include, but are not more than 120 days after embryo col- limited to: lection, and not less than 60 days after (1) The existence of communicable any previously administered diseases of livestock, other than those intradermal test for tuberculosis. diseases specifically listed, in the re- (7)(i) Not less than 30 days nor more gion of origin; than 120 days after embryo collection, (2) A high prevalence or an increase the donor dam was examined by an of- in the incidence of a communicable dis- ficial veterinarian and found free of ease in the region of origin; clinical evidence of the following dis- (3) The use of natural breeding, rath- eases: er than artificial insemination to con- (A) Ruminant: Bovine spongiform ceive the embryos; encephalopathy, brucellosis, con- (4) The use of fresh, rather than fro- tagious bovine pleuropneumonia, foot- zen semen, for artificial insemination; and-mouth disease, Rift Valley fever, and rinderpest, tuberculosis, and vesicular (5) The use of semen collected at a stomatitis; or site other than an artificial insemina- (B) Swine: African swine fever, bru- tion center approved by the national cellosis, foot-and-mouth disease, clas- government of the region of origin. sical swine fever, pseudorabies, rinder- (c) Embryos produced by any donor pest, swine vesicular disease, tuber- dam or sire that dies before being ex- culosis, and vesicular stomatitis. amined and tested as required under (ii) All signs of any other commu- this subpart will not be eligible for im- nicable disease must be listed on the portation into the United States. health certificate that accompanies [56 FR 55809, Oct. 30, 1991, as amended at 61 the embryos to the United States. FR 15183, Apr. 5, 1996; 62 FR 56025, Oct. 28, (8)(i) Between the time the embryos 1997; 68 FR 16940, Apr. 7, 2003] were collected and all examinations and tests required by this subpart were § 98.16 The embryo collection unit. completed, no animals in the embryo Ruminant and swine embryos may be collection unit with the donor dam, or imported into the United States from a in the donor dam’s herd of origin, ex- region where rinderpest or foot-and- hibited any clinical evidence of: mouth disease exists only if they were (A) Ruminant: Bovine spongiform conceived, collected, processed, and encephalopathy, brucellosis, con- stored prior to importation at an em- tagious bovine pleuropneumonia, foot- bryo collection unit. The embryo col- and-mouth disease, Rift Valley fever, lection unit may be located on the rinderpest, tuberculosis, and vesicular premises where the donor dam’s herd of stomatitis; or origin is kept, or at any other location,

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provided that the embryo collection constructed of materials that can with- unit has been inspected and approved stand repeated cleaning and disinfec- by an APHIS veterinarian and that the tion. following requirements are met: [56 FR 55809, Oct. 30, 1991, as amended at 61 (a) Animal holding and breeding FR 15184, Apr. 5, 1996; 62 FR 56025, Oct. 28, area(s). The embryo collection unit 1997] must have an area or areas for holding the donor dams and for breeding them § 98.17 Procedures. (either natural breeding or artificial (a) Housing of the donor dam. (1) Be- insemination). ginning at least 24 hours before a donor (b) Embryo collection area. The embryo dam is bred to produce embryos for im- collection must have a room or outdoor portation to the United States, the area for collection of embryos that donor dam must be housed at an em- contains a device or devices for re- bryo collection unit. straining embryo donors during em- (2) The donor dam must remain at bryo collection. If a room, the floor, the embryo collection unit until the walls, and ceiling must be impervious embryos for importation into the to moisture and constructed of mate- United States have been collected. rials that can withstand repeated (3) After collection of embryos, the cleaning and disinfection. If an outdoor donor dam must either remain at the area, the area must have a floor that is embryo collection unit or be returned impervious to moisture and is con- to the herd of origin and remain there structed of materials that can with- until all examinations and tests re- stand repeated cleaning and disinfec- quired by this subpart have been com- tion. If the outdoor area also has walls pleted. or a roof, the walls or roof also must be (4) During the time the donor dam is impervious to moisture and be con- in the embryo collection unit, in ac- structed of materials that can with- cordance with paragraphs (a)(1) stand repeated cleaning and disinfec- through (a)(3) of this section, no ani- tion. mals may be in the embryo collection (c) Embryo processing area. The em- unit with the donor dam unless: bryo collection unit must have an en- (i) They meet the requirements of closed room, which may be mobile, § 98.15 of this subpart that are applica- that is used only for processing em- ble to the donor dam at that time; bryos. The walls, floor, and ceiling of (ii) They are part of the donor dam’s the room must be impervious to mois- herd of origin; or ture and constructed of materials that (iii) They are serving as donor sires can withstand repeated cleaning and for the production of embryos to be im- disinfection. The room must contain a ported into the United States. work surface for handling the embryos, (b) Oversight and supervision. (1) All such as a table or countertop that is procedures associated with the produc- impervious to moisture. The room also tion of embryos for importation into must contain a microscope with a min- the United States, including artificial imum of 50x magnification, and equip- insemination, natural breeding, and ment for freezing the embryos. cleaning and disinfection, must be per- (d) Embryo storage area. The embryo formed under the oversight of an collection unit must have one lockable APHIS veterinarian. Collecting test area that is used only for storing fro- samples, and collecting, processing, zen embryos intended for importation and storing embryos, must be super- into the United States. vised in person by an APHIS veteri- (e) Area for cleaning and disinfecting or narian. sterilizing equipment. The embryo col- (2) Officials from the Animal and lection unit must have an enclosed Plant Health Inspection Service must room used for cleaning and disinfecting be given access to all areas of the em- or sterilizing equipment used for artifi- bryo collection unit and the donor cial insemination or for collection, dam’s herd of origin during the time processing, or storage of embryos. The the donor dam is housed there, in ac- walls, floor, and ceiling of the room cordance with paragraphs (a)(1) must be impervious to moisture and through (a)(3) of this section.

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(c) Personnel. All personnel must put used for artificial insemination or for on clean outer garments, including dis- collection, processing, or storage of infected boots, and must scrub their embryos must be kept free of insects, hands with soap and water each time rodents, trash, manure, and other ani- they enter the embryo collection unit mal matter and must be cleaned with and before entering any room or area soap and water and disinfected before listed in § 98.16 of this subpart. being used to prepare equipment for do- (d) Cleaning, disinfection, and steriliza- nors of embryos intended for importation. (1) All equipment that comes in tion into the United States, and at contact with embryos or with media least daily while in use for this pur- used for their collection or processing pose. must be sterile. Equipment used for (e) Media; cryogenic agent. (1) All embryos from one donor dam, or with media containing products of animal associated media, may not be used for origin and used for embryo collection embryos or associated media from any and processing must be from sources in other donor dam until it has been resterilized. the United States or Canada. (2) All equipment that comes in con- (2) The liquid nitrogen used to freeze tact with a donor dam’s secretions or embryos may not have been used pre- excretions must be sterile and may not viously for any other products of ani- be used with any other donor dam until mal origin. it has been resterilized. (f) Collection and processing of embryos. (3) Containers used for storing em- (1) If embryos are collected in an out- bryos or for shipping embryos to the door area, they must be collected by United States must be examined and using a closed collection system so found free of any organic matter and that the embryos are not exposed to then disinfected before the ampules or open air until they are inside the em- straws are placed inside. bryo processing room. (4) The floor, ceiling, and walls of any (2) Embryos from donors that do not room or outdoor area used for embryo meet the requirements of § 98.15 of this collection, and the restraining de- subpart that are applicable at the time vice(s) used for this procedure, must be of embryo collection may not be in the cleaned with soap and water and dis- processing room at the same time as infected before the room or area is used embryos intended for importation into to collect embryos intended for impor- the United States. tation to the United States, and at (3) Each embryo must be washed at least daily while in use for this pur- least 10 times. Each wash must be ac- pose. complished by transferring the embryo (5) The room and work surface used into an aliquot of fresh medium that is for processing embryos must be kept 100 times the volume of the embryo free of insects, rodents, trash, manure, plus any fluid transferred from the pre- and other animal matter and must be vious wash. No more than 10 embryos cleaned with soap and water and dis- from the same flush may be washed to- infected before the room is used for embryos intended for importation to gether. A sterile micropipette must be the United States, and the work sur- used for each transfer, and the embryos face must be cleaned and disinfected at must be well agitated throughout the least daily while in use for this pur- entire volume of the wash before the pose. next transfer. Embryos from different (6) The area of the embryo collection donors may not be washed together. unit used to store embryos intended for (4) After the last wash, each embryo importation to the United States must must be microscopically examined over be kept free of insects, rodents, trash, its entire surface at not less than 50× manure, and other animal matter and magnification. An embryo may not be must be cleaned with soap and water imported into the United States unless and disinfected before being used to its zona pellucida is found to be intact store the embryos. and free from any adherent material. (7) The room used for cleaning and (5) After washing and examination of disinfecting or sterilizing equipment the zona pellucida, embryos must be

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individually packaged in sterile am- (h) Storage of embryos. (1) Frozen em- pules or straws and frozen in liquid ni- bryos to be imported into the United trogen. The donor dam’s and sire’s States must be stored in a locked area identifications and breed, the date of or must remain in the custody of an of- embryo collection, the name and ad- ficial veterinarian until they are sealed dress of the place where the embryos in accordance with paragraph (h)(2) of were collected, and an identification this section and released for shipment number for the straw or ampule must to the United States in accordance be recorded with indelible markings on with § 98.18(a) of this subpart; except each ampule or straw. If any of this in- that, the embryos may be moved to a formation is provided in code, deci- U.S. Department of Agriculture-oper- phering information must be attached ated animal import center in either to the health certificate for the em- New York, Hawaii, or Florida, under bryos. seal and in the custody of that indi- (6) The Administrator may require vidual, and remain in quarantine there additional measures to be taken in until all tests and examinations reprocessing embryos after collection quired by this subpart have been com- (for example, adding trypsin to the pleted and all test results have been washes) if he or she determines that provided by the Foreign Animal Dis- such measures are necessary to ensure ease Diagnostic Laboratory. the embryos freedom from infectious (2) Containers in which embryos will agents that may cause communicable be imported into the United States diseases. Circumstances that may re- must be sealed by an official veteri- sult in such additional measures being narian with the official seal of the re- required include, but are not limited gion of origin or, if the official veteri- to: narian is an employee of the Animal (i) The existence of communicable and Plant Health Inspection Service, diseases of livestock, other than those with an official seal of the United diseases specifically listed, in the re- States Department of Agriculture. The gion of origin; and seal number must be recorded on the (ii) A high prevalence or an increase health certificate that accompanies in the incidence of a communicable dis- the embryos to the United States. ease in the region of origin. (Approved by the Office of Management and (g) Preparation of test samples; tests. (1) Budget under control number 0579–0040) All nontransferrable embryos and [56 FR 55809, Oct. 30, 1991, as amended at 61 unfertilized eggs from each collection FR 15184, Apr. 5, 1996; 62 FR 56026, Oct. 28, of embryos intended for importation 1997] into the United States must be pooled, frozen in liquid nitrogen, and sent to § 98.18 Shipment of embryos to the the Foreign Animal Disease Diagnostic United States. Laboratory for testing under the per- (a) Release from the embryo collection sonal supervision of an APHIS veteri- unit. Except as provided in § 98.17(h)(1) narian. The collection and last two of this subpart, embryos may not be wash fluids from the collection of em- moved from the embryo collection unit bryos must be frozen and sent to the until all tests and examinations re- Foreign Animal Disease Diagnostic quired by this subpart have been com- Laboratory for testing under the per- pleted and the Import-Export Animals sonal supervision of an APHIS veteri- Staff, Veterinary Services, APHIS, has narian. Samples from different collec- received written notification of all test tions may not be mixed. results from the Foreign Animal Dis- (2) All samples collected in accord- ease Diagnostic Laboratory. ance with paragraph (g)(1) of this sec- (b) Route. The sealed shipping con- tion must be tested and found negative tainers must be routed directly to the for viral contamination. The wash U.S. port of entry designated on the fluids also must be found negative for import permit. bacterial contamination. The only offi- (c) Ports of entry. The embryos may cial results for these tests will be those be imported into the United States provided by the Foreign Animal Dis- only through a port of entry listed in ease Diagnostic Laboratory. § 93.203(a) of this chapter.

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(d) Date of arrival in the United States. text otherwise requires, they shall be Embryos that arrive at the port of construed, respectively, to mean: entry more than 14 days after the pro- Administrator. The Administrator of posed date of arrival stated in the im- the Animal and Plant Health Inspec- port permit will not be eligible for im- tion Service or any other employee of portation into the United States. the Animal and Plant Health Inspec- [56 FR 55809, Oct. 30, 1991, as amended at 62 tion Service, United States Depart- FR 56026, Oct. 28, 1997] ment of Agriculture, to whom authority has been or may be delegated to act § 98.19 Arrival and inspection at the in the Administrator’s stead. port of entry. Animal and Plant Health Inspection (a) Upon arrival at the port of entry, Service. The Animal and Plant Health the importer or the importer’s agent Inspection Service of the United States must present an inspector at the port Department of Agriculture (APHIS or with the original health certificate and Service.) the original import permit for the em- Animals. Cattle, sheep, goats, other bryos. ruminants, swine, horses, asses, zebras, (b) The shipping container and all and poultry. straws or ampules containing embryos Cattle. Animals of the bovine species. must be made available to an inspector Communicable disease. Any con- at the port of entry for inspection, and tagious, infectious, or communicable may not be removed from the port of disease of domestic livestock, poultry entry until an inspector determines or other animals. that the embryos are eligible for entry Department. The United States De- in accordance with this subpart and re- partment of Agriculture (USDA). leases them. Flock. A herd. Herd. All animals maintained on any § 98.20 Embryos refused entry. single premises; and all animals under If any embryos are determined to be common ownership or supervision on ineligible for importation into the two or more premises which are geo- United States upon arrival at the port graphically separated, but among of entry, the importer must remove the which there is an interchange or move- embryos from the United States within ment of animals. 30 days, or the embryos will be de- Horses. Horses, asses, mules, and ze- stroyed. bras. Inspector. An employee of the Animal § 98.21 Embryos from sheep in regions and Plant Health Inspection Service other than Australia, Canada, and authorized to perform duties required New Zealand. under this subpart. Except for embryos from sheep in Port veterinarian. A veterinarian em- Australia, Canada, or New Zealand, ployed by the Animal and Plant Health embryos from sheep may only be im- Inspection Service to perform duties ported into the United States if they required under this part at a port of comply with all applicable provisions entry. of this subpart and with § 98.10a. Poultry. Chickens, doves, ducks, geese, grouse, guinea fowl, partridges, (Approved by the Office of Management and pea fowl, pheasants, pigeons, quail, Budget under control numbers 0579–0040 and 0579–0101) swans, and turkeys (including eggs for hatching). [61 FR 17242, Apr. 19, 1996] Region. Any defined geographic land area identifiable by geological, polit- Subpart C—Certain Animal Semen ical, or surveyed boundaries. A region may consist of any of the following: SOURCE: 55 FR 31558, Aug. 2, 1990, unless (1) A national entity (country); otherwise noted. (2) Part of a national entity (zone, county, department, municipality, par- § 98.30 Definitions. ish, Province, State, etc.) Whenever in this subpart of the fol- (3) Parts of several national entities lowing terms are used, unless the con- combined into an area; or

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(4) A group of national entities (coun- region other than the region in which tries) combined into a single area. it was collected. Restricted zone for classical swine fever. [55 FR 31558, Aug. 2, 1990. Redesignated at 56 An area, delineated by the relevant FR 55809, Oct. 30, 1991, and amended at 58 FR competent veterinary authorities of 37643, July 13, 1993; 59 FR 26596, May 23, 1994; the region in which the area is located, 62 FR 56026, Oct. 28, 1997] that surrounds and includes the location of an outbreak of classical swine § 98.32 Inspection of certain aircraft fever in domestic swine or detection of and other means of conveyance and shipping containers thereon; un- the disease in wild boar, and from loading, cleaning, and disinfection which the movement of domestic swine requirements. is prohibited. (a) Inspection: All aircraft and other Ruminants. All animals which chew means of conveyance (including ship- the cud, such as cattle, buffaloes, ping containers thereon) moving into sheep, goats, deer, antelopes, camels, the United States from any foreign re- llamas and giraffes. gion are subject to inspection without Swine. The domestic hog and all vari- a warrant by properly identified and eties of wild hogs. designated inspectors to determine United States. All of the States of the whether they are carrying any animal, United States, the District of Colum- carcass, product or article regulated or bia, Guam, Northern Mariana Islands, subject to disposal under any law or Puerto Rico, the Virgin Islands of the regulation administered by the Sec- United States, and all other Territories retary of Agriculture for prevention of and Possessions of the United States. the introduction or dissemination of any communicable animal disease. [55 FR 31558, Aug. 2, 1990. Redesignated at 56 (b) Unloading requirements: Whenever FR 55809, Oct. 30, 1991; 61 FR 17242, Apr. 19, in the course of any such inspection at 1996; 62 FR 56026, Oct. 28, 1997; 65 FR 56777, Sept. 20, 2000; 71 FR 29071, May 19, 2006; 72 FR any port in the United States the in- 67233, Nov. 28, 2007; 76 FR 70039, Nov. 10, 2011; spector has reason to believe that the 77 FR 1396, Jan. 10, 2012] means of conveyance or container is contaminated with material of animal § 98.31 General prohibitions; excep- (including poultry) origin, such as, but tions. not limited to, meat, organs, glands, (a) No product subject to the provi- extracts, secretions, fat, bones, blood, sions of this subpart shall be brought lymph, urine, or manure, so as to present a danger of the spread of any into the United States except in ac- communicable animal disease, the in- cordance with the regulations in this spector may require the unloading of subpart and part 94 of this subchapter; the means of conveyance and the nor shall any such product be handled emptying of the container if he or she or moved after physical entry into the deems it necessary to enable him or United States before final release from her to determine whether the means of quarantine or any other form of gov- conveyance or container is in fact so ernmental detention except in compli- contaminated. The principal operator ance with such regulations; Provided, of the means of conveyance and his or That, except as prohibited by section her agent in charge of the means of 306 of the Act of June 17, 1930, as conveyance shall comply with any such amended (19 U.S.C. 1306), the Adminis- requirement under the immediate su- trator may upon request in specific pervision of, and in the time and man- cases permit products to be brought ner prescribed by, the inspector. into or through the United States (c) Cleaning and disinfection: When- under such conditions as he or she may ever, upon inspection under this sec- prescribe, when he or she determines in tion, an inspector determines that a the specific case that such action will means of conveyance or shipping con- not endanger the livestock or poultry tainer is contaminated with material of the United States. of animal origin so as to present a dan- (b) Animal semen may not be im- ger of the spread of any communicable ported into the United States from any animal disease, he or she shall notify

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the principal operator of the means of Honolulu, Hawaii; Chicago, Illinois; conveyance or his or her agent in New Orleans, Louisiana; Portland, charge, of such determination and the Maine; Baltimore, Maryland; Boston, requirements under this section. The Massachusetts; International Falls and person so notified shall cause the Minneapolis, Minnesota; Great Falls, cleaning and disinfection of such Montana; Portland, Oregon; San Juan, means of conveyance and container Puerto Rico; Memphis, Tennessee; Gal- under the immediate supervision of, veston and Houston, Texas; Seattle, and in the time and manner prescribed Spokane, and Tacoma, Washington. by, the inspector. (e) Designation of other ports. The Sec- (d) For purposes of this section, the retary of the Treasury has approved term ‘‘shipping container’’ means any the designation as quarantine stations container of a type specially adapted of the ports specified in this section. In for use in transporting any article on special cases other ports may be des- the means of conveyance involved. ignated as quarantine stations under [55 FR 31558, Aug. 2, 1990. Redesignated at 56 this section by the Administrator, with FR 55809, Oct. 30, 1991; 62 FR 56026, Oct. 28, the concurrence of the Secretary of the 1997; 68 FR 6345, Feb. 7, 2003] Treasury.

§ 98.33 Ports designated for the impor- [55 FR 31558, Aug. 2, 1990. Redesignated at 56 tation of certain animal semen. FR 55809, Oct. 30, 1991, and amended at 58 FR 37643, July 13, 1993; 60 FR 16045, Mar. 29, 1995; (a) Air and ocean ports. The following 60 FR 25120, May 11, 1995; 64 FR 23179, Apr. 30, air and ocean ports are designated as 1999; 65 FR 38178, June 20, 2000; 67 FR 68022, having inspection facilities for the November 8, 2002] entry of animal semen: Los Angeles, California; Miami, Florida; and New- § 98.34 Import permits for poultry burgh, New York. semen and animal semen. (b) Canadian border ports. The fol- (a) Application for permit; reservation lowing land border ports are designated required. (1) For poultry semen and ani- as having inspection facilities for the mal semen, intended for importation entry of animal semen from Canada: from any part of the world, except as Eastport, Idaho; Houlton and Jackman, otherwise provided for in § 98.36, the Maine; Detroit, Port Huron, and Sault importer shall first apply for and ob- Ste. Marie, Michigan; Baudette, Min- tain from APHIS an import permit. nesota; Opheim, Raymond, and The application shall specify the name Sweetgrass, Montana; Alexandria Bay, and address of the importer; the spe- Buffalo, and Champlain, New York; cies, breed, quantity of animal semen Dunseith, Pembina, and Portal, North to be imported; the purpose of the im- Dakota; Derby Line and Highgate portation; individual animal identifica- Springs, Vermont; Oroville and Sumas, tion (except poultry) which includes a Washington. description of the animal, name, age, (c) Mexican border ports. The fol- markings, if any, registration number, lowing land border ports are designated if any, and tattoo or eartag; the region as having inspection facilities for the of origin; the name and address of the entry of animal semen from Mexico: exporter; the port of embarkation in Douglas, Naco, Nogales, San Luis, and the foreign region; the mode of trans- Sasabe, Arizona; Calexico and San portation, route of travel, and the port Ysidro, California; Antelope Wells, Co- of entry in the United States; the pro- lumbus, and Santa Teresa, New Mex- posed date of arrival of the animal ico; Brownsville, Del Rio, Eagle Pass, semen to be imported; and the name of El Paso, Hidalgo, Laredo, and Presidio, the person to whom the animal semen Texas. will be delivered and the location of (d) Limited ports. The following lim- the place in the United States to which ited ports are designated as having in- delivery will be made from the port of spection facilities for the entry of ani- entry. Additional information may be mal semen: Anchorage and Fairbanks, required in the form of certificates Alaska; San Diego, California; Jack- concerning specific diseases to which sonville, St. Petersburg-Clearwater, the animals are susceptible, as well as and Tampa, Florida; Atlanta, Georgia; vaccinations or other precautionary

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treatments to which the animals or Poultry semen and animal semen for animal semen have been subjected. No- which a permit is required by these tice of any such requirements will be regulations will not be eligible for given to the applicant in each case. entry if a permit has not been issued; if (2) An application for permit to im- unaccompanied by such a permit; if port will be denied for semen from shipment is from any port other than ruminants or swine from any region the one designated in the permit; if ar- where it has been declared, under sec- rival in the United States is at any tion 306 of the Act of June 17, 1930, that port other than the one designated in foot-and-mouth disease or rinderpest the permit; if the animal semen offered has been determined to exist, except as for entry differs from that described in provided in paragraph (c) of this sec- the permit; or if the animal semen is tion. not handled as outlined in the applica- (3) An application for permit to im- tion for the permit and as specified in port poultry semen or animal semen the permit issued. may also be denied because of: Commu- (c) Animal semen from regions where nicable disease conditions in the area rinderpest or foot-and-mouth disease ex- or region of origin, or in a region ists. Importation of semen of ruminants through which the shipment has been or swine, originating in any region des- or will be transported; deficiencies in ignated in paragraph (a) of § 94.1 of this the regulatory programs for the con- subchapter as a region where rinder- trol or eradication of animal diseases pest or foot-and-mouth disease is deter- and the unavailability of veterinary mined to exist, is prohibited, except services in the above mentioned re- that semen from ruminants or swine gions; the importer’s failure to provide originating in such a region may be of- satisfactory evidence concerning the fered for entry into the United States origin, history, and health status of the at the port of New York and later re- animals or animal semen; the lack of leased from such port provided the fol- satisfactory information necessary to lowing conditions have been fulfilled: determine that the importation will (1) The importer has applied for and not be likely to transmit any commu- obtained an import permit for the nicable disease to livestock or poultry semen in accordance with the provi- of the United States; or any other cir- sions of this section and related re- cumstances which the Administrator quirements concerning application believes require such denial to prevent therefor, which permit is in effect at the dissemination of any commu- the time of importation, and has depos- nicable disease of livestock or poultry ited with the Department prior to the into the United States. issuance of the permit sufficient funds (b) Permit. When a permit is issued, so as to be available for defraying esti- the original and two copies will be sent mated expenses to be incurred in con- to the importer. It shall be the respon- nection with the proposed semen im- sibility of the importer to forward the portation and following the issuance of original permit and one copy to the the permit has deposited such other shipper in the region of origin, and it amounts as may be required from time shall also be the responsibility of the to time to defray unanticipated costs importer to insure that the shipper or increased expenses. Such an import presents the copy of the permit to the permit may be denied for the reasons carrier and makes proper arrangements specified in paragraph (a)(3) of this sec- for the original permit to accompany tion. Furthermore, an import permit the shipment to the specified U.S. port will be revoked unless the following of entry for presentation to the col- conditions have been complied with: lector of customs. Animal semen in- (i) The donor animal shall have been tended for importation into the United inspected on the farm of origin or on States for which a permit has been another premises (the inspection may issued, will be received at the specified be on another premises only if a veteri- port of entry within the time pre- narian of the Department has traced scribed in the permit which shall not the donor animal back to its farm of exceed 14 days from the first day that origin) by a veterinarian of the United the permit is effective for all permits. States Department of Agriculture who,

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in cooperation with the veterinary Foreign Animal Disease Diagnostic service of the region of origin of the Laboratory, Greenport, New York, and donor animal, shall have determined, to any other test for rinderpest, foot- insofar as possible, that the donor ani- and-mouth disease or other commu- mal was never infected with rinderpest nicable disease prescribed by the Ad- or foot-and-mouth disease; that the ministrator. donor animal was never on a farm or (iv) In the case of a ruminant, each other premise where rinderpest or foot- blood sample collected pursuant to and-mouth disease then existed; that paragraph (c)(1)(ii) or (vi) of this sec- the donor animal has not been on a tion shall have been tested for foot- premise that had an animal that was and-mouth disease using the virus in- susceptible to the virus of rinderpest or fection associated (VIA) test and each foot-and-mouth disease and that was O-P sample collected pursuant to para- exposed to either disease during the 12 graph (c)(1)(ii) or (iv) of this section months immediately prior to the date shall have been tested for foot-and- of inspection of the donor animal; that mouth disease using the virus isolation the donor animal, if a ruminant, has test. In the case of a swine, each blood never been vaccinated against rinder- sample collected pursuant to paragraph pest; that the donor animal, if a swine, (c)(1)(ii) or (vi) of this section shall has never been vaccinated against rin- have been tested for foot-and-mouth derpest or foot-and-mouth disease; and disease using the virus infection associ- that the donor animal was free from ated (VIA) test and the virus neutral- evidence of other communicable dis- ization test.’’ 1 ease; (v) Following isolation, preliminary (ii) The donor animal shall have been veterinary inspection, and testing permanently identified in a manner while the donor animal was on the satisfactory to a veterinarian of this farm of origin or other acceptable loca- Department; a blood sample and an tion, the donor animal shall have been oesophageal-pharyngeal tissue sample transported, under such conditions as (O-P sample) from such a donor rumi- the Department veterinarian pre- nant and a blood sample from such a scribed to prevent exposure of the ani- donor swine for tests as specified in mal to the virus of rinderpest or foot- paragraph (c)(1)(iv) of this section or and-mouth disease, to an isolation fa- other tests shall have been collected by cility properly equipped for the nec- a veterinarian of the United States De- essary care and maintenance of the partment of Agriculture and trans- donor animal and for the proper collec- ported by air to the New York Port tion and handling of semen, approved Veterinarian for delivery to the For- by a veterinarian of this Department and under the direct supervision of eign Animal Disease Diagnostic Lab- such veterinarian; oratory, Greenport, New York, in con- (vi) The semen of the donor animal tainers approved by a veterinarian of shall have been collected at the ap- this Department, sealed in the region proved isolation facility under the di- of origin by a veterinarian of this De- rect supervision of a veterinarian of partment; and pending the results of this Department (any number of collec- the tests, the donor animal shall have tions may be made); such veterinarian been kept in isolation on the farm of shall take a 0.5 ml sample of semen origin or other acceptable location from each semen collection; and all under the supervision of a veterinarian handling procedures, such as examina- of this Department, and during such tion, dilution, refrigeration, and prepa- isolation period no animal susceptible ration of the semen for shipment, shall to rinderpest or foot-and-mouth disease have been under the direct supervision shall have been permitted to enter such farm or location and no other source of exposure to rinderpest or foot-and- 1 The test procedures for the virus infection mouth disease shall have been present; associated (VIA) test, the virus isolation test, and the virus neutralization test are (iii) The blood samples from the available from the Chief, Foreign Animal donor animal shall have been negative Disease Diagnostic Laboratory, National to the tests specified in paragraph Veterinary Services Laboratories, P.O. Box (c)(1)(iv) of this section made at the 848, Greenport, NY 11944.

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of a veterinarian of this Department. (5) The semen sample from each col- In the case of a ruminant, a blood sam- lection shall have consisted of unproc- ple and an O-P sample shall have been essed semen without any added sub- taken from the donor animal by a vet- stances, and shall have been tested at erinarian of the Department within 7 the Foreign Animal Disease Diagnostic days after the final semen collection, Laboratory, Greenport, New York. and between 21 to 28 days after the tak- Such tests shall have been performed ing of these samples another blood by injecting the semen samples into sample shall have been taken from the test animals which are susceptible to donor animal by a veterinarian of the rinderpest or foot-and-mouth disease. Department. In the case of a swine, a The semen collected at the approved blood sample shall have been taken isolation facility, other than the semen from the donor animal by a veteri- samples, may be held in the region of narian of the Department within 7 days origin or at the port of New York, at after the final semen collection, and the option of the importer, until all of between 21 to 28 days after the taking the testing required to be conducted of the sample, another blood sample under this section is completed. shall have been taken from the donor (6) If it is determined that the re- animal by a veterinarian of the Depart- quirements set forth in this paragraph ment. have been complied with and there are (2) The semen collected at the ap- no indications that the donor animal proved isolation facility shall have or the semen from the donor animal harbors the virus of rinderpest or foot- been at all times, except during air and-mouth disease or any other com- transportation to New York, in the municable disease and if the donor ani- custody of a veterinarian of this De- mal, blood samples from the donor ani- partment. mal, O-P samples (if applicable) from (3) The semen for which an import the donor animal, and semen samples permit has been issued shall have been from the donor animal are negative to transported by air to the port of New all other tests required, the semen York in liquid nitrogen containers ap- shall be released for shipment to the proved by a veterinarian of this De- consignee listed by the importer; oth- partment; sealed in the region of origin erwise the semen shall be destroyed or by a veterinarian of this Department; disposed of as the Administrator, may and accompanied by a statement by direct. such veterinarian showing the identi- (7) Porcine semen from the People’s Re- fication of the donor animal and the public of China. In addition to the other dates the semen was collected, along requirements of this part, porcine with a certificate regarding the health semen may be imported into the status of the donor animal as of the United States from the People’s Repub- date of shipment of the semen to the lic of China (PRC) only after the offi- port of New York. All semen received cial veterinary organization (OVO) of at the port of New York shall be held the PRC has certified that the PRC is under quarantine in liquid nitrogen free of African swine fever, rinderpest, storage at such port in the custody of and Teschen’s disease, and after the APHIS until released or otherwise dis- following conditions have been ful- posed of as provided in this section. filled: (4) The donor animal shall have been (i) The donor boars must pass a 60- retained at the approved isolation fa- day isolation/collection period in a facility in the region where the semen cility jointly approved by the OVO of was collected until all of the applicable the PRC and the USDA as adequate to samples referred to in paragraph prevent exposure of the donor boars to (c)(1)(vi) of this section have been col- infectious diseases. Any other swine at lected by a veterinarian of the Depart- the isolation facility, such as teaser ment for tests as specified in paragraph animals, must also meet the require- (c)(1)(iv) of this section at the Foreign ments of this paragraph. No animals Animal Disease Diagnostic Laboratory, may be added to the group after the Greenport, New York, and any other start of the 60-day isolation/collection tests as required by the Administrator. period. The Department will permit

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collection of semen to be initiated at culosis, or pseudorabies on these prem- the beginning of the isolation/collec- ises or on premises adjacent to these tion period. The facility shall be premises for one year prior to the col- cleaned and disinfected with a 4 per- lection of semen. cent sodium carbonate solution used in (iii) During the 60-day isolation/col- accordance with applicable label in- lection period, the boars offered for structions in the presence of OVO quar- collection of semen shall be subjected antine personnel prior to the start of to the following tests, 2 in lieu of the the isolation. During the isolation/col- tests required by paragraphs (c)(1)(iv) lection period, personnel handling the and (vi) of this section. If test samples animals shall not have contact with from any donor boars are lost, dam- other domestic farm livestock (this aged, or destroyed prior to testing, or term does not include pets such as dogs if test results are inconclusive, the and cats). Raw animal food wastes donor boars involved shall be subjected (garbage) shall not be fed to the donor to retesting: boars while in isolation. At the start of (A) Foot-and-mouth disease: the isolation/collection period, and (1) Microtiter virus neutralization again after 14 days of isolation, all ani- (VN) test for types, A, O, C, and Asia. mals offered for collection of semen (The PRC will test for types A and O, must be given an intramuscular injec- and the United States will test for tion of dihydrostreptomycin at a rate types C and Asia at the USDA Foreign of 25 mg/kg dosage as a precautionary Animal Disease Diagnostic Laboratory treatment for leptospirosis. Feed and (FADDL)). bedding used during the isolation/col- (2) Agar gel immunodiffusion (AGID) lection period shall not originate from test using virus infection associated areas infected with epizootic diseases antigen (VIAA) in serum. (Animals and must meet veterinary hygienic re- having responses to the AGID test or quirements established by the OVO of reacting to the VN test at 1:10 dilution the PRC concerning freedom of the feed or greater shall be eliminated as semen and bedding from contamination that donors, and all other swine in contact could transmit diseases. During the with them shall be retested within 30 isolation/collection period the swine at days. If the whole group does not have the collection center shall not have di- the above responses and there is no rect contact with, or exposure to, any clinical evidence of FMD, the group other animals not included in the shall be eligible for collection of semen group at the isolation facility. Expo- with respect to FMD. Otherwise, none sure consists of contact with yards, of the group shall qualify as donors of pens, or other facilities or vehicles that semen for export.) have been in contact with animals and (B) Brucellosis: Standard tube test have not been cleaned and disinfected. (STT) at less than 30 IU/ml, and card (ii) Donor boars shall be selected test (antigen and protocol to be sup- from premises which are solely swine plied by USDA). breeding operations. These premises (C) Swine vesicular disease: Virus must be located at the center of an neutralization test at 1:40 dilution (se- area with a 16 km radius that was free rums to be tested at FADDL). of foot-and-mouth disease (FMD), (D) Classical swine fever: Fluorescent swine vesicular disease (SVD), and antibody neutralization (FAN) test at classical swine fever for three years 1:16 dilution. prior to semen collection. Donor boars (E) Japanese B encephalitis: shall not have been vaccinated against Hemagglutination inhibition (HI) test, these diseases. There shall have been negative according to PRC standards. no cases of these diseases on these (F) Pseudorabies: Virus neutraliza- premises for five years prior to the col- tion at 1:4 dilution. lection of semen. There shall have been no animal introduced into these prem- 2 Technical information on laboratory ises from farms affected with these dis- methods and procedures for these tests may eases for three years prior to the col- be obtained from the Administrator, c/o Di- lection of semen. There shall have been rector, National Veterinary Services Labora- no evidence of brucellosis, tuber- tories, P.O. Box 844, Ames, IA 50010.

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(G) Tuberculosis: Intradermal test identification consistent with the pro- using bovine PPD tuberculin (Positive visions of § 79.2 of this chapter; and animals will be necropsied. If there are (2) Records of any sale of F1 progeny, lesions of TB in the test positive pigs, including the name and address of the the whole group will be ineligible as buyer, will be kept for a period of 5 semen donors. If no lesions are found, years. APHIS may view and copy these the rest of the pigs will be eligible as records during normal business hours. semen donors with respect to tuberculosis. [55 FR 31558, Aug. 2, 1990. Redesignated at 56 FR 55809, Oct. 30, 1991, and amended at 58 FR All samples of the above tests, except 37644, July 13, 1993; 59 FR 26596, May 23, 1994; as noted for FMD, SVD, and TB, will be 62 FR 56026, Oct. 28, 1997; 68 FR 16940, Apr. 7, submitted to laboratories designated 2003; 72 FR 64128, Nov. 15, 2007] by the OVO of the PRC. At least 21 days after the final collection of semen § 98.35 Declaration, health certificate, for exportation, the donor animals will and other documents for animal be retested for the diseases listed semen. above, with the exception of tuber- (a) The certificates, declarations, and culosis and Japanese encephalitis. In affidavits required by the regulations addition, aliquots of each ejaculate of in this subpart shall be presented by semen collected shall be submitted to the importer or his or her agent to the FADDL for pathogen isolation tests for collector of customs at the port of FMD, brucellosis, swine vesicular dis- entry, upon arrival of animal semen at ease, classical swine fever, Japanese such port, for the use of the veterinary encephalitis, and pseudorabies. inspector at the port of entry. (iv) The semen will not be eligible for (b) For all animal semen offered for release in the United States until all importation, the importer or his or her tests in paragraph (c)(7)(iii) of this sec- agent shall first present two copies of a tion have been completed with nega- declaration which shall list the port of tive results. entry, the name and address of the im- (v) Each semen straw or ampule for porter, the name and address of the export must be identified with the broker, the origin of the animal semen, name or identification number of the the number, breed, species, and purpose donor boar and with the date of collec- of the importation, the name of the tion. A USDA veterinarian shall certify person to whom the animal semen will that he or she has supervised the col- be delivered, and the location of the lection and processing of the semen place to which such delivery will be and its storage until the time it is made. shipped to the United States. Each shipment will be accompanied by a (c) All animal semen intended for im- USDA veterinarian unless the semen is portation into the United States shall shipped directly to the port of New be accompanied by a health certificate York, with no stops en route. Shipment issued by a full-time salaried veteri- to the United States will be in accord- nary officer of the national govern- ance with the terms of a USDA import ment of the region of origin, or issued permit. Semen imported in accordance by a veterinarian designated or accred- with this section shall be released by ited by the national government of the USDA to the importer only after all re- region of origin and endorsed by a full- quirements of this section have been time salaried veterinary officer of the met. national government of the region of (d) Sheep and goat semen from regions origin, representing that the veteri- where scrapie exists. Importation of narian issuing the certificate was au- semen of sheep and goats is subject to thorized to do so. the requirements in § 98.35(e). Applica- (d) The health certificate must state: tions for a permit to import sheep and (1) The name and address of the place goat semen must include statements where the semen was collected; that: (2) The name and address of the vet- (1) All first generation (F1) progeny erinarian who supervised the collection resulting from imported semen will be of the semen; identified with a permanent official (3) The date of semen collection;

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(4) The identification and breed of (iv) The feeding of sheep and goats the donor animal; with meat-and-bone meal or greaves (5) The number of ampules or straws derived from ruminants has been covered by the health certificate and banned and the ban effectively en- the identification number or code on forced in the whole region; and each ampule or straw; (3) Semen originating in regions (6) The dates, types, and results of all other than Australia and New Zealand examinations and tests performed on is to be transferred to females in a the donor animal as a condition for im- flock that is listed in the Scrapie Na- porting the semen; tional Database as part of the Scrapie (7) The seal number on the shipping Program in the United States. Im- container; ported semen may be further distrib- (8) The names and addresses of the uted to any other listed flock with consignor and consignee; and (9) That the semen is being imported written notification to the APHIS Vet- into the United States in accordance erinary Services area office. with subpart C of 9 CFR part 98. (f) All shipping containers carrying (e) The certificate accompanying animal semen for importation into the sheep or goat semen intended for im- United States must be sealed with an portation from any part of the world official seal of the national veterinary shall, in addition to the statements re- service of the region of origin. The quired by paragraph (d) of this section, health certificate must show the seal state that: number on the shipping container. The (1) The donor animals: semen must remain in the sealed con- (i) Are permanently identified, to en- tainer until arrival in the United able traceback to their establishment States and, at the U.S. port of entry, of origin; and an inspector determines that either: (ii) Have been kept since birth in es- (1) The seal numbers on the health tablishments in which no case of certificate and shipping container scrapie had been confirmed during match; or their residency; and (2) The seal numbers on the health (iii) Neither showed clinical signs of certificate and shipping container do scrapie at the time of semen collection not match, but an APHIS representa- nor developed scrapie between the time tive at the port of entry is satisfied of semen collection and the export of that the shipping container contains semen to the United States; and the semen described on the health cer- (iv) The dam of the semen donor is tificate, import permit, declaration, not, nor was not, affected with scrapie. (2) In the region where the semen and any other accompanying docu- originates: ments. (i) Scrapie is a compulsorily (Approved by the Office of Management and notifiable disease; and Budget under control number 0579–0040) (ii) An effective surveillance and [55 FR 31558, Aug. 2, 1990. Redesignated at 56 monitoring system for scrapie is in FR 55809, Oct. 30, 1991, as amended at 58 FR place; and 37644, July 13, 1993; 61 FR 15184, Apr. 5, 1996; (iii) Affected sheep and goats are 61 FR 17242, Apr. 19, 1996; 62 FR 56026, Oct. 28, slaughtered and completely destroyed; 1997; 65 FR 56777, Sept. 20, 2000; 72 FR 64128, and Nov. 15, 2007]

§ 98.36 Animal semen from Canada. (a) General importation requirements for animal semen from Canada.

If the product is . . . Then . . .

(1) Equine semen ...... There are no importation requirements under this part.

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If the product is . . . Then . . .

(2) Sheep or goat semen.... The importer or his agent, in accordance with §§ 98.34 and 98.35 of this part, must present: (i) An import permit; (ii) Two copies of a declaration; and (iii) A health certificate.

(3) Animal semen other See paragraph (b) of this section. than equine, sheep, or goat semen.

(b) Importation requirements for animal semen other than equine, sheep, or goat semen from Canada.

If the product is offered for And . . . Or . . . Then . . . entry at a ...

(1) Canadian The donor animal The donor animal The importer or his land border was born in Can- was legally im- agent, in accord- port listed ada or the United ported into Can- ance with § 98.35 of in § 98.33(b) States and has ada, released to this part, must of this part. never been in a remove freely in present: gion other than Canada, and has (i) Two copies of a Canada or the been released in declaration; and United States. Canada for no less (ii) A health certifi- than 60 days. cate.

(2) Canadian The donor animal The importer or his land border does not meet the agent, in accord- port listed special conditions ance with §§ 98.34 in § 98.33(b) listed above in and 98.35 of this of this part. paragraph (b)(1) of part, must this table. present: (i) An import permit; (ii) Two copies of a declaration; and (iii) A health certificate. (3) Port not The importer or his listed in agent, in accord- § 98.33(b) of ance with §§ 98.34 this part. and 98.35 of this part, must present: (i) An import permit; (ii) Two copies of a declaration; and (iii) A health certificate.

[65 FR 56778, Sept. 20, 2000]

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§ 98.37 [Reserved] (d) The semen must not have been collected from a donor boar that § 98.38 Restrictions on the importation transited any region or zone described of swine semen from the APHIS-de- in paragraphs (b)(1) through (b)(3) of fined European CSF region. this section during the periods de- In addition to meeting all other ap- scribed, unless the donor boar was plicable provisions of this part, swine moved directly through the region or semen imported from the APHIS-de- zone in a sealed means of conveyance fined European CSF region, as defined with the seal determined to be intact in § 94.0 of this subchapter, must meet upon arrival at the point of destina- the following conditions, except as tion, or unless the semen was collected noted in paragraph (h) of this section after the periods described; with regard to swine semen imported (e) The donor boar must be held in from Denmark, Finland, the Republic isolation for at least 30 days prior to of Ireland, Sweden, or the United King- entering the semen collection center. dom: (f) No more than 30 days prior to (a) The semen must come from a being held in isolation as required by semen collection center approved for paragraph (e) of this section, the donor export by the competent veterinary au- boar must be tested with negative re- thority. sults with a classical swine fever test (b) The semen must not have been approved by the World Organization for collected from a donor boar that was in Animal Health. any of the following regions or zones, (g) No equipment or materials used unless the semen was collected after in transporting the donor boar from the periods described: the farm of origin to the semen collec- (1) Any region when the region was tion center may have been used pre- classified under §§ 94.9(a) and 94.10(a) of viously for transporting swine that do this chapter as a region in which clas- not meet the requirements of this sec- sical swine fever is known to exist, ex- tion, unless such equipment or mate- cept for the APHIS-defined European rials have first been cleaned and dis- CSF region; infected. (2) A restricted zone in the APHIS- (h) Except for semen collected from defined European CSF region estab- swine in Denmark, Finland, the Repub- lished because of the detection of clas- lic of Ireland, Sweden, or the United sical swine fever in domestic swine, Kingdom, before the semen is exported from the time of detection until the to the United States, the donor boar designation of the zone as a restricted must be held at the semen collection zone is removed by the competent vet- center and observed by the center veterinary authority or until 6 months erinarian for at least 40 days following following depopulation of the swine on collection of the semen, and, along affected premises in the restricted zone with all other swine at the semen col- and the cleaning and disinfection of the lection center, exhibit no clinical signs last affected premises in the zone, of classical swine fever. whichever is later; or (i) The semen must be accompanied (3) A restricted zone in the APHIS- by a certificate issued by a salaried defined European CSF region estab- veterinary officer of the competent lished because of the detection of clas- veterinary authority, stating that the sical swine fever in wild boar, from the provisions of paragraphs (a) through time of detection until the designation (h) of this section have been met. 3 of the zone as a restricted zone is removed by the competent veterinary au- (Approved by the Office of Management and thority. Budget under control numbers 0579–0218 and (c) The semen must not have been 0579–0265) collected from a donor boar that was [71 FR 29072, May 19, 2006, as amended at 72 commingled with swine that at any FR 67233, Nov. 28, 2007; 76 FR 70040, Nov. 10, time were in any of the regions or 2011; 77 FR 1396, Jan. 10, 2012] zones described in paragraphs (b)(1) through (b)(3) of this section, unless 3 The certification required may be placed the semen was collected after the peri- on the certificate required under § 98.35(c) or ods described. may be contained in a separate document.

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EFFECTIVE DATE NOTE: At 77 FR 74558, Dec. Act of July 2, 1962, section 6(a), as amended 17, 2012, § 98.38 was amended by, in the intro- (21 U.S.C. 134e), ductory text, removing the words ‘‘, except Act of May 6, 1970, section 2, as amended (21 as noted in paragraph (h) of this section with U.S.C. 135a). regard to swine semen imported from Den- The Animal Health Protection Act, section mark, Finland, the Republic of Ireland, Swe- 10414 (7 U.S.C. 8313) den, or the United Kingdom’’; by removing paragraph (h); by redesignating paragraph (i) In addition, the Supplemental Rules of as paragraph (h); and in newly redesignated paragraph (h), by removing the words Practice set forth in subpart B of this ‘‘through (h)’’ and adding the words part shall be applicable to such pro- ‘‘through (g)’’ in their place, effective Jan. ceedings. 16, 2013. [48 FR 30095, June 30, 1983. Redesignated at 52 FR 29502, Aug. 10, 1987, as amended at 68 FR PART 99—RULES OF PRACTICE 6345, Feb. 7, 2003] GOVERNING PROCEEDINGS UNDER CERTAIN ACTS Subpart B—Supplemental Rules of Practice Subpart A—General Sec. § 99.10 Stipulations. 99.1 Scope and applicability of rules of prac- (a) At any time prior to the issuance tice. of a complaint seeking a civil penalty Subpart B—Supplemental Rules of Practice under any of the Acts listed in § 99.1, the Administrator, in his discretion, 99.10 Stipulations. may enter into a stipulation with any AUTHORITY: 7 U.S.C. 8301–8317; 7 CFR 2.22, person in which: 2.80, and 371.4. (1) The Administrator or the Admin- SOURCE: 48 FR 30095, June 30, 1983, unless istrator’s delegate gives notice of an otherwise noted. Redesignated at 52 FR 29502, apparent violation of the applicable Aug. 10, 1987. Act, or the regulations issued thereunder, by such person and affords such Subpart A—General person an opportunity for a hearing regarding the matter as provided by such § 99.1 Scope and applicability of rules of practice. Act; (2) Such person expressly waives The Uniform Rules of Practice for the Department of Agriculture promul- hearing and agrees to pay a specified gated in subpart H of part 1, subtitle A, penalty within a designated time; and title 7, Code of Federal Regulations, (3) The Administrator agrees to ac- are the Rules of Practice applicable to cept the penalty in settlement of the adjudicatory, administrative pro- particular matter involved if the pen- ceedings under the following statutory alty is paid within the designated time. provisions: (b) If the penalty is not paid within the time designated in such a stipula- Act of May 29, 1884, commonly known as the Animal Industry Act, section 7, as amend- tion, the amount of the stipulated pen- ed (21 U.S.C. 117), alty shall not be relevant in any re- Act of August 30, 1890, section 6, as amended spect to the penalty which may be as- (21 U.S.C. 104), sessed after issuance of a complaint. Act of February 2, 1903, commonly known as the Cattle Contagious Diseases Act of 1903, [48 FR 30095, June 30, 1983. Redesignated and section 3, as amended (21 U.S.C. 122), amended at 52 FR 29502, Aug. 10, 1987]

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PART 101—DEFINITIONS immunostimulants, certain cytokines, antigenic or immunizing components Sec. of live organisms, and diagnostic com- 101.1 Applicability. ponents, that are of natural or syn- 101.2 Administrative terminology. thetic origin, or that are derived from 101.3 Biological products and related terms. synthesizing or altering various sub- 101.4 Labeling terminology. stances or components of substances 101.5 Testing terminology. such as microorganisms, genes or ge- 101.6 Cell cultures. netic sequences, carbohydrates, pro- 101.7 Seed organisms. teins, antigens, allergens, or anti- AUTHORITY: 21 U.S.C. 151–159; 7 CFR 2.22, bodies. 2.80, and 371.4. (1) A product’s intended use shall be SOURCE: 38 FR 8426, Apr. 2, 1973, unless oth- determined through an objective stand- erwise noted. ard and not a subjective one, and would be dependent on factors such as rep- § 101.1 Applicability. resentations, claims (either oral or When used in parts 101 through 117 of written), packaging, labeling, or ap- this subchapter, the meaning of the pearance. words and phrases listed shall be as de- (2) The term analogous products shall fined in this part. include: (i) Substances, at any stage of pro- § 101.2 Administrative terminology. duction, shipment, distribution, or The following administrative words sale, which are intended for use in the and phrases shall mean: treatment of animals and which are Adjacent herd. Adjacent herds are similar in function to biological prod- herds physically contiguous to the herd ucts in that they act, or are intended of origin; there are no herds between to act, through the stimulation, sup- an adjacent herd and the herd of origin. plementation, enhancement, or modu- Administrator. The Administrator, lation of the immune system or im- Animal and Plant Health Inspection mune response; or Service, or any person authorized to (ii) Substances, at any stage of pro- act for the Administrator. duction, shipment, distribution, or Animal and Plant Health Inspection sale, which are intended for use in the Service. The agency in the Department treatment of animals through the de- of Agriculture responsible for admin- tection or measurement of antigens, istering the Virus-Serum-Toxin Act. antibodies, nucleic acids, or immunity; Biological products. The term biologi- or cal products, also referred to in this (iii) Substances, at any stage of pro- subchapter as biologics, biologicals, or duction, shipment, distribution, or products, shall mean all viruses, se- sale, which resemble or are represented rums, toxins (excluding substances as biological products intended for use that are selectively toxic to microorga- in the treatment of animals through nisms, e.g., antibiotics), or analogous appearance, packaging, labeling, products at any stage of production, claims (either oral or written), rep- shipment, distribution, or sale, which resentations, or through any other are intended for use in the treatment means. of animals and which act primarily (3) The term treatment shall mean the through the direct stimulation, sup- prevention, diagnosis, management, or plementation, enhancement, or modu- cure of diseases of animals. lation of the immune system or im- Department. The U.S. Department of mune response. The term ‘‘biological Agriculture. products’’ includes but is not limited Distributor. A person who sells, dis- to vaccines, bacterins, allergens, anti- tributes, or otherwise places in chan- bodies, antitoxins, toxoids, nels of trade, one or more biological

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products he does not produce or im- Licensed establishment. An establish- port. ment operated by a person holding an Division. A marketing unit estab- unexpired, unsuspended, and unrevoked lished by the licensee which may be U.S. Veterinary Biologics Establish- named on labels, advertisements and ment License. promotional material in addition to Licensee. A person to whom an estab- the name and address of the producer. lishment license and at least one prod- Domestic animals. All animals, other uct license has been issued. than man, including poultry. Microorganisms. Microscopic or sub- Establishment. One or more premises microscopic organisms, which are designated on the establishment li- sometimes referred to as organisms, cense. which may introduce or disseminate Guidelines. Guidelines establish prin- disease of animals. ciples or practices related to test pro- Nonadjacent herd. Nonadjacent herds cedures, manufacturing practices, are all herds other than the herd of ori- product standards, scientific protocols, gin and other than herds adjacent to labeling, and other technical or policy the herd of origin. Herds adjacent to considerations. Guidelines contain pro- the herd of origin but in a different cedures or standards of general applica- State from the herd of origin are also bility that are usually not regulatory considered nonadjacent herds. in nature, but that are related to mat- Permittee. A person who resides in the ters that fall under the Virus-Serum- United States or operates a business Toxin Act. Guidelines issued by the establishment within the United agency include Veterinary Biologics States, to whom a permit to import bi- Licensing Considerations, Memoranda, ological products has been issued. Notices, and Supplemental Assay Person. Any individual, firm, partner- Methods. ship, corporation, company, associa- Herd. Any group of animals, includ- tion, educational institution, State or ing birds, fish, and reptiles, maintained local governmental agency, or other at a common location (e.g. lot, farm or organized group of any of the fore- ranch) for any purpose. The herd (or going, or any agent, officer, or em- flock) includes all animals subse- ployee of any thereof. quently housed at the common loca- Premises. All buildings, appur- tion. If the principal animals of a group tenances, and equipment used to are moved to a different location, the produce and store biological products group is still considered the same herd. located within a particular land area Herd of origin. The herd from which shown on building plans or drawings the microorganism used as seed for furnished by the applicant or the li- production of an autogenous biologic is censee and designated by an address isolated. Offspring and excess breeding adequate for identification. stock (not the principal animals) Prepare or preparation. Sometimes removed or sold from one group of ani- ferred to as manufacture or produce, mals to another have changed herds means the steps and procedures used in and are no longer considered part of the processing, testing, packaging, la- the herd they originated from. Groups beling, and storing of a biological prod- of animals under the same ownership uct. but at different locations are separate Regulations. The provisions in parts herds. 101 through 118 of this subchapter. Inspection. An examination made by Research investigator or research spon- an inspector to determine the fitness of sor. A person who has requested au- animals, establishments, facilities, and thorization to ship an experimental bi- procedures used in connection with the ological product for the purpose of preparation, testing, and distribution evaluating such product, or has been of biological products and the examina- granted such authorization. tion or testing of biological products. Secretary. The Secretary of Agri- Inspector. Any officer or employee of culture of the United States or any of- Animal and Plant Health Inspection ficer or employee of the Department to Service who is authorized by the Ad- whom authority has heretofore been ministrator to do inspection work. delegated, or to whom authority may

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hereafter be delegated, to act in his unrevoked product license for such stead. product. Subsidiary. A corporation in which a (b) Experimental biological product. A corporate licensee owns in excess of 50 biological product which is being eval- percent of the voting stock. uated to substantiate an application Veterinary Services. Veterinary Serv- for a product license or permit. ices unit of Animal and Plant Health (c) Completed product. A biological Inspection Service of the Department. product in bulk or final container pro- Virus-Serum-Toxin Act. The Act of duced in compliance with the regula- March 4, 1913, 37 Stat. 832–833; as tions to final form and composition. amended December 23, 1985, Public Law (d) Finished product. A completed 99–198, 99 Stat. 1654–1655; and as further product which has been bottled, sealed, amended September 28, 1988, Public packaged, and labeled as required by Law 100–449, 102 Stat. 1868; 21 U.S.C. the regulations. 151–159. (e) Released product. A finished prod- U.S. Veterinary Biological Product Li- uct released for marketing after all re- cense. A document, sometimes referred quirements have been satisfactorily to as a product license, which is issued complied with. pursuant to part 102 of this subchapter (f) Fraction. A specific antigen, its to the holder of an establishment li- antibodies, or its antitoxin which con- cense, as a part of and ancillary to the stitutes a component of a biological establishment license, and which au- product. thorizes production of a specified bio- (g) Diluent. A liquid used to re- logical product in the designated li- hydrate a desiccated product or a liq- censed establishment. uid used to dilute another substance. U.S. Veterinary Biological Product Per- (h) Serial. The total quantity of commit. A document, sometimes referred to pleted product which has been thor- as a permit, issued to a person author- oughly mixed in a single container and izing the importation of specified bio- identified by a serial number: Provided, logical products subject to restrictions That, when all or part of a serial of liq- and controls as provided in the regula- uid biological product is packaged as tions. diluent for all or part of a serial of des- U.S. Veterinary Biologics Establishment iccated product, the resulting combina- License. A document referred to as an tion packages shall be considered a se- establishment license, which is issued rial of the multiple fraction product. pursuant to part 102 of this subchapter, (i) Subserial. Each of two or more authorizing the use of designated prem- properly identified portions of a serial ises for production of biological prod- which are further processed at different ucts specified in one or more unex- times or under different conditions pired, unsuspended, and unrevoked such as, but not limited to, being des- product license(s). iccated in different size final containers and/or at different times. [38 FR 8426, Apr. 2, 1973; 38 FR 9221, Apr. 12, (j) Outline of production. A detailed 1973, as amended at 40 FR 46093, Oct. 6, 1975; 41 FR 44358, Oct. 8, 1976; 49 FR 22624, May 31, protocol of methods of manufacture to 1984; 52 FR 30131, Aug. 13, 1987; 56 FR 66782, be followed in the preparation of a bio- 66783, Dec. 26, 1991; 57 FR 38756, Aug. 27, 1992; logical product and which may some- 62 FR 31328, June 9, 1997; 64 FR 43044, Aug. 9, times be referred to as an outline. 1999] (k) Product Code Number. A number assigned by Animal and Plant Health § 101.3 Biological products and related Inspection Service to each type of li- terms. censed biological product. When used in conjunction with or in (l) Harvest date. Unless otherwise reference to a biological product, the specified in a filed Outline of Produc- following terms shall mean: tion, the harvest date shall be the date (a) Licensed biological product. A bio- blood or tissues are collected for pro- logical product prepared within a li- duction or the date cultures of living censed establishment by a person hold- microorganisms are removed from pro- ing an unexpired, unsuspended, and duction incubators.

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(m) Bacterin. An inactivated bacterial (1) Upon or attached to a final con- product consisting of an antigenic sus- tainer of a biological product; pension of organisms or particulate (2) Appearing upon any immediate parts of organisms, representing a carton or box used to package such whole culture or a concentrate thereof, final container; and with or without the unevaluated (3) Appearing on any accompanying growth products, which has been inac- enclosures (leaflets, inserts, or circu- tivated as demonstrated by acceptable lars) on which required information or tests written into the filed Outline of directions as to the use of the biologi- Production for the product. cal product shall be found. (n) Toxoid. An inactivated bacterial (b) Labeling. All labels and other product which consists of a sterile, an- written, printed, or graphic matter ac- tigenic toxin or toxic growth product, which has resulted from the growth of companying the final container. bacterial organisms in a culture me- (c) Final container. The unit, bottle, dium from which the bacterial cells vial, ampule, tube, or other receptacle have been removed, which has been in- into which any biological product is activated without appreciable loss of filled for distribution and sale. antigenicity as measured by suitable (d) True name. The name entered on tests, and which is nontoxic as dem- the product license or permit at the onstrated by acceptable tests written time of issuance to differentiate the bi- into the filed Outline of Production. ological product from others: Provided, (o) Bacterin-toxoid. An inactivated That, the principal part of such name bacterial product which is either: shall be emphasized on such license or (1) A suspension of organisms, rep- permit by being more prominently let- resenting a whole culture or a con- tered than descriptive terms which centrate thereof, with the toxic growth may be necessary to complete the dif- products from the culture which has ferentiation. been inactivated without appreciable (e) Serial number. Numbers or num- loss of antigenicity as measured by bers and letters used to identify and suitable tests, the inactivation of orga- distinguish one serial from others. nisms and toxins being demonstrated (f) Expiration date. A date designating by acceptable tests written into the the end of the period during which a bi- filed Outline of Production: Provided, ological product, when properly stored That it shall contain cellular antigens and handled, can be expected with rea- and shall stimulate the development of sonable certainty, to be efficacious. antitoxin; or (g) A number assigned (2) A combination product in which Label number. one or more toxoids or bacterin-toxoids by Animal and Plant Health Inspection is combined with one or more bacterins Service to each label or sketch sub- or one or more bacterin-toxoids. mitted for review. (p) Bacterial extract. An inactivated (h) Master label. The finished carton, bacterial product which consists of the container, or enclosure label for the sterile, nontoxic, antigenic derivatives smallest size final container that is au- extracted from bacterial organisms or thorized for a biological product, that from culture medium in which bac- serves as the Master template label ap- terial organisms have grown. plicable to all other size containers or cartons of the same product that is [38 FR 8426, Apr. 2, 1973, as amended at 42 FR marketed by a licensee, subsidiary, di- 63770, Dec. 20, 1977; 50 FR 24903, June 14, 1985; 56 FR 66782, Dec. 26, 1991; 60 FR 14354, Mar. 17, vision, or distributor. 1995] [38 FR 8426, Apr. 2, 1973, as amended at 42 FR 63770, Dec. 20, 1977; 56 FR 66782, Dec. 26, 1991; § 101.4 Labeling terminology. 61 FR 29464, June 11, 1996] Terms pertaining to identification and packaging of biological products § 101.5 Testing terminology. shall mean: Terms used when evaluating biologi- (a) Label. All written, graphic, or cal products shall mean: printed matter:

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(a) Standard Requirement. Test meth- parison or to add validity to the re- ods, procedures, and criteria estab- sults. lished by Animal and Plant Health In- (k) Day. Time elapsing between any spection Service for evaluating biologi- regular working hour of one day and cal products to be pure, safe, potent, any regular working hour of the fol- and efficacious, and not to be worth- lowing day. less, contaminated, dangerous, or (l) No test. A test which produces in- harmful under the Act. conclusive or invalid results and there- (b) Log. Logarithm computed to the fore, cannot be used to evaluate a bio- base 10. logical product. (c) Pure or purity. Quality of a bio- (m) Healthy. Apparently normal in all logical product prepared to a final form vital functions and free of signs of dis- relatively free of extraneous micro-or- ease. ganisms and extraneous material (or- (n) Unfavorable reactions. Overt ad- ganic or inorganic) as determined by verse changes which occur in healthy test methods or procedures established test animals subsequent to initiation by Animal and Plant Health Inspection of a test and manifested during the ob- Service in Standard Requirements or servation period prescribed in the test in the approved Outline of Production protocol which are attributable either for such product, but free of extraneous to the biological product being tested microorganisms or material which in or to factors unrelated to such product the opinion of the Administrator ad- as determined by the responsible indi- versely affects the safety, potency, or vidual conducting the test. efficacy of such product. (o) Master reference. A Master Ref- (d) Safe or safety. Freedom from prop- erence is a reference whose potency is erties causing undue local or systemic correlated, directly or indirectly, to reactions when used as recommended host animal immunogenicity. The Mas- or suggested by the manufacturer. ter Reference may be used as the work- (e) Sterile or sterility. Freedom from ing reference in in vitro tests for rel- viable contaminating microorganisms ative potency. The Master Reference as demonstrated by procedures pre- may also be used to establish the rel- scribed in part 113 of this subchapter, ative potency of a serial of product Standard Requirements, and approved used in requalification studies and to Outlines of Production. establish the relative potency of work- (f) Potent or potency. Relative ing references. The preparation of a strength of a biological product as de- Master Reference as described in a filed termined by test methods or proce- Outline of Production may be: dures as established by Animal and (1) A completed serial of vaccine or Plant Health Inspection Service in bacterin prepared in accordance with a Standard Requirements or in the ap- filed Outline of Production; proved Outline of Production for such (2) A purified preparation of a protec- product. tive immunogen or antigen; or (g) Efficacious or efficacy. Specific (3) A nonadjuvanted harvested cul- ability or capacity of the biological ture of microorganisms. product to effect the result for which it (p) Working reference. A Working Ref- is offered when used under the condi- erence is the reference preparation tions recommended by the manufac- that is used in the in vitro test for the turer. release of serials of product. Working (h) Dose. The amount of a biological References may be: product recommended on the label to (1) Master References; or be given to one animal at one time. (2) Serials of product that have been (i) Vaccinate. An animal which has prepared and qualified, in a manner ac- been inoculated, injected, or otherwise ceptable to Animal and Plant Health administered a biological product Inspection Service for use as reference being evaluated. preparations. (j) Control animal. An animal, which (q) Qualifying serial. (1) A serial of bi- may be referred to as a control, used in ological product used to test for a test procedure for purposes of com- immunogenicity when the Master or

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Working Reference is a purified anti- (d) Master Cell Stock (MCS). The sup- gen or nonadjuvanted harvest material. ply of cells of a specific passage level Qualifying serials shall be produced in from which cells for production of bio- accordance with the filed Outline of logics originate. Production, tested for immunogenicity in accordance with methods deemed [38 FR 8426, Apr. 2, 1973, as amended at 40 FR appropriate by the Animal and Plant 45419, Oct. 2, 1975; 49 FR 22624, May 31, 1984] Health Inspection Service, and have a geometric mean relative potency, when § 101.7 Seed organisms. compared to the Master Reference, of When used in conjunction with or in not greater than 1.0 as established by: reference to seed organisms, the fol- independent parallel line assays with lowing shall mean: five or more replicates; or other valid (a) Master Seed. An organism at a spe- assay methods for determining relative cific passage level which has been se- antigen content which demonstrate lected and permanently stored by the linearity, specificity, and reproduc- producer from which all other seed pas- ibility at least equivalent to the par- sages are derived within permitted lev- allel line assay and are acceptable to els. the Animal and Plant Health Inspec- (b) Working Seed. An organism at a tion Service. passage level between Master Seed and (2) Qualifying serials used to re- Production Seed. qualify or extend the dating period of a Master Reference shall be determined (c) Production Seed. An organism at a to be immunogenic in accordance with specified passage level which is used methods deemed appropriate by the without further propagation for initi- Animal and Plant Health Inspection ating preparation of a fraction. Service as provided in paragraph (a)(1) [49 FR 22625, May 31, 1984] of this section, and, in addition, shall be within their permitted dating period and have been prepared in accordance PART 102—LICENSES FOR with the production method described BIOLOGICAL PRODUCTS in the currently filed Outline of Pro- duction. Sec. (r) Immunogenicity. The ability of a 102.1 Licenses issued by the Administrator. biological product to elicit an immune 102.2 Licenses required. response in animals as determined by 102.3 License applications. test methods or procedures acceptable 102.4 U.S. Veterinary Biologics Establish- to the Animal and Plant Health Inspec- ment License. tion Service. 102.5 U.S. Veterinary Biological Product Li- cense. [38 FR 8426, Apr. 2, 1973, as amended at 40 FR 102.6 Conditional licenses. 45419, Oct. 2, 1975; 41 FR 6751, Feb. 13, 1976; 43 FR 3701, Jan. 27, 1978; 56 FR 66782, 66783 Dec. AUTHORITY: 21 U.S.C. 151–159; 7 CFR 2.22, 26, 1991; 62 FR 19037, Apr. 18, 1997] 2.80, and 371.4.

§ 101.6 Cell cultures. § 102.1 Licenses issued by the Adminis- When used in conjunction with or in trator. reference to cell cultures, which may Each establishment qualified to pre- be referred to as tissue cultures, the pare biological products under the following terms shall mean: Virus-Serum-Toxin Act shall hold an (a) Batches of primary cells. A pool of unexpired and unrevoked U.S. Veteri- original cells derived from normal tis- nary Biologics Establishment License sue up to and including the 10th sub- issued by the Administrator and a U.S. culture. Veterinary Biological Product License (b) Cell line. A pool of cells which are for each product prepared in such es- 11 or more subcultures from the tissue tablishment unless the product is sub- of origin. ject to the provisions of 9 CFR parts (c) Subculture. Each flask to flask 103 or 106 of this subchapter. transfer or passage regardless of the number of cell replications. [60 FR 48021, Sept. 18, 1995]

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§ 102.2 Licenses required. (6) A new application shall be made when a change of ownership, operation, (a) Every person who prepares bio- or location of an establishment occurs; logical products subject to the Virus- or prior to the expiration of a U.S. Vet- Serum-Toxin Act shall hold an unex- erinary Biologics Establishment Li- pired, unsuspended, and unrevoked U.S. cense issued for an interim period of Veterinary Biologics Establishment Li- time. cense and at least one unexpired, un- (b) U.S. Veterinary Biological Product suspended, and unrevoked U.S. Veteri- License. (1) The licensee of each estab- nary Biological Product License issued lishment or applicant for an establish- by the Administrator to prepare a bio- ment license shall make written appli- logical product. cation to the Administrator for a U.S. (b) An applicant who applies for an Veterinary Biological Product License establishment license must also apply for each biological product to be pre- for at least one product license. An es- pared in the licensed establishment. tablishment license will not be issued (2) Each application for a U.S. Veteri- without a license authorizing the pro- nary Biological Product License shall duction of a biological product in the be supported by: establishment. (i) At least two copies of an Outline [52 FR 11026, Apr. 7, 1987, as amended at 56 of Production prepared in accordance FR 66783, Dec. 26, 1991; 61 FR 52873, Oct. 9, with §§ 114.8 and 114.9 of this sub- 1996] chapter; and (ii) At least three copies of test re- § 102.3 License applications. ports and research data sufficient to (a) U.S. Veterinary Biologics Establish- establish purity, safety, potency, and ment License. (1) The operator of each efficacy of the product; and establishment of the kind specified in (iii) Legends prepared as prescribed § 102.2 shall make written application in § 108.5 of this subchapter designating to the Administrator for a license. which facilities are to be used in the Blank forms of application will be fur- preparation of each fraction; and nished upon request to Animal and (iv) Labels in finished form or Plant Health Inspection Service. sketches prepared as prescribed in (2) When a person conducts more § 112.5 of this subchapter, together with than one establishment, a separate ap- information regarding all claims to be plication shall be made for each estab- made on labels and in advertising mat- lishment. ter to be used in connection with or re- (3) Whenever subsidiaries are to oper- lated to the biological product. ate in an establishment for which li- (Approved by the Office of Management and cense application is made, the appli- Budget under control number 0579–0013) cant shall apply for permission for such [39 FR 37763, Oct. 24, 1974, as amended at 48 subsidiaries to operate in the establish- FR 57472, Dec. 30, 1983; 49 FR 21043, May 18, ment and furnish therewith a complete 1984; 50 FR 50763, Dec. 12, 1985; 56 FR 66783, statement regarding the relationship Dec. 26, 1991; 75 FR 20772, Apr. 21, 2010] between the applicant and the subsidiaries. § 102.4 U.S. Veterinary Biologics Estab- (4) Facilities documents, prepared as lishment License. prescribed in part 108 of this sub- (a) Before a U.S. Veterinary Biologics chapter, shall accompany the applica- Establishment License will be issued tion for license unless previously filed by the Administrator for any establish- with Animal and Plant Health Inspec- ment, an inspection shall be made to tion Service. determine whether the condition, (5) Each application for a U.S. Veteri- equipment, facilities, and the like, of nary Biologics Establishment License the establishment, and the methods shall be accompanied by an application used to prepare biological products are for one or more U.S. Veterinary Bio- in conformity with the requirements in logical Product Licenses and the sup- the regulations. porting documents required by para- (b) A license shall not be issued un- graph (b)(2) of this section. less:

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(1) In the opinion of the Adminis- operations conducted in the licensed trator, the condition of the establish- establishment. ment, including its facilities, and the (f) When a licensee no longer holds at methods of preparation of biological least one unexpired, unsuspended, or products are such as reasonably to as- unrevoked product license authorizing sure that the products shall accomplish the preparation of a biological product, the purpose for which they are in- or is in the process of obtaining a prod- tended; and uct license, the establishment license (2) The Administrator is satisfied on shall no longer be valid and shall be re- the basis of information before him turned to the Administrator. In the that: case where an establishment license (i) The establishment shall be oper- expires or is suspended or revoked, any ated in compliance with the Act and product license authorizing prepara- applicable regulations and be under the tion of a product at such establishment supervision of person(s) competent in shall be invalid indefinitely or for as the preparation of biological products; long as the suspension is in effect. and (g) Any license issued under this part (ii) The applicant, or the person hav- to establishments in which biological products are prepared shall be issued ing the responsibility for producing bi- on condition that the licensee permit ological products in the establishment, the inspection of such establishments, or both, is qualified by education and products, product preparation, and all experience, and has demonstrated fit- relevant records as provided in part 115 ness to produce such products in com- of this subchapter. Failure to permit pliance with the Act and regulations inspection may result in the license issued pursuant thereto; Provided, being suspended or revoked. That, previous violations of the Act, or (h) The provisions of paragraph (b) of such regulations or both shall be rel- this section shall also be applicable to, evant to the Administrator’s deter- and be considered by, the Adminis- mination of fitness. trator in connection with each applica- (3) Written assurance is filed with tion for an additional product license. Animal and Plant Health Inspection Service that the biological products (Approved by the Office of Management and which are licensed to be prepared Budget under control number 0579–0013) therein shall not be so advertised as to [39 FR 37762, Oct. 24, 1974; 39 FR 38364, Nov. 1, mislead or deceive the purchasers and 1974, as amended at 41 FR 44359, Oct. 8, 1976; that the packages or containers in 48 FR 57472, Dec. 30, 1983; 52 FR 11026, Apr. 7, which the same are to be marketed 1987; 52 FR 30131, Aug. 13, 1987; 56 FR 66783, Dec. 26, 1991; 60 FR 48021, Sept. 18, 1995; 61 FR shall not bear any statement, design, 52873, Oct. 9, 1996; 62 FR 13294, Mar. 20, 1997] or device which is false or misleading in any particular. § 102.5 U.S. Veterinary Biological (c) U.S. Veterinary Biologics Estab- Product License. lishment Licenses shall be numbered. (a) Authorization to produce each bi- (d) Two or more licenses may bear ological product shall be specified on a the same number when they are issued U.S. Veterinary Biological Product Li- for establishments under the same cense, issued by the Administrator, and ownership or control, provided a serial supplementary to the U.S. Veterinary letter is added to one or more to iden- Biologics Establishment License tify each license and the product pro- named therein. duced thereunder. (b) The following shall appear on the (e) When a U.S. Veterinary Biologics U.S. Veterinary Biological Product Li- Establishment License is issued for an cense: establishment, it shall not apply to (1) The U.S. Veterinary Biologics Es- more than one person at the same loca- tablishment License Number for the es- tion, except that subsidiaries of the li- tablishment from which the product is censee, when named in the license, may released for marketing. operate thereunder at the establish- (2) The true name of the product. ment named. The licensee with its sub- (3) The product code number for the sidiaries will be held responsible for all product.

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(4) The date of issuance. needed. Copies of any supporting docu- (5) Any restrictions designated by the ments, such as scientific literature, Administrator under paragraph (e) of published or unpublished articles, or this section. data from tests, should be attached to (6) When necessary to comply with the request. When a decision is reached § 102.6 of this part, a termination date regarding the request, the person sub- and a brief description of requirements mitting the request will be sent writ- to be met for reissuance. ten notification of such decision. (c) The following provisions shall (Approved by the Office of Management and apply to all licensed biological prod- Budget under control number 0579–0013) ucts: (1) Licensed biological products shall [39 FR 37763, Oct. 24, 1974, as amended at 48 FR 57472, Dec. 30, 1983; 50 FR 50764, Dec. 12, be prepared as required by the regula- 1985; 52 FR 11026, Apr. 7, 1987; 56 FR 66783, tions and in accordance with a filed Dec. 26, 1991; 57 FR 38760, Aug. 27, 1992; 59 FR Outline of Production as prescribed in 67616, Dec. 30, 1994; 62 FR 13294, Mar. 20, 1997; §§ 114.8 and 114.9 of this subchapter. No 64 FR 43044, Aug. 9, 1999; 75 FR 20772, Apr. 21, change shall be made in the prepara- 2010] tion of a biological product without prior approval of the Administrator. § 102.6 Conditional licenses. (2) In addition to restrictions im- In order to meet an emergency condi- posed by the Administrator pursuant tion, limited market, local situation, to paragraph (e) of this section, bio- or other special circumstance, includ- logical products may be subject to re- ing production solely for intrastate use strictions which are imposed by any under a State-operated program, the State or other jurisdiction pertaining Administrator may, in response to an to the distribution and use of such application submitted as specified in products, based on local disease condi- § 102.3(b) of this part, issue a conditions. tional U.S. Veterinary Biological Prod- (3) When requested by the Adminis- uct License to an establishment under trator, a licensee shall submit a list of an expedited procedure which assures licensed biological products prepared purity and safety, and a reasonable ex- in the licensed establishment. pectation of efficacy. Preparation of (d) Where the Administrator deter- products under a conditional license mines that the protection of domestic shall be in compliance with all applica- animals or the public health, interest, ble regulations and standards and may or safety, or both, necessitates restric- be restricted as follows: tions on the use of a product, the prod- (a) The preparation may be limited uct shall be subject to such additional to a predetermined time period which restrictions as are prescribed on the li- shall be established at the time of cense. Such restrictions may include, issuance and specified on the license. but are not limited to, limits on dis- Prior to termination of the license, the tribution of the product or provisions licensee may request reissuance. Such that the biological product is re- requests shall be substantiated with stricted to use by veterinarians, or data and information obtained since under the supervision of veterinarians, the license was issued. After consid- or both. ering all data and information avail- (e) Any person may request that the able, the Administrator shall either re- distribution and use of a veterinary bi- issue the U.S. Veterinary Biological ological product be restricted if the re- Product License or allow it to termi- striction pertains to the protection of nate. domestic animals or the public health, (b) Distribution may be limited to interest, or safety, or both. All re- the extent necessary to assure that the quests must be sent, in writing, to the product will meet the basic criteria for Director, Center for Veterinary Bio- issuance of the conditional license. logics, Policy, Evaluation, and Licens- (c) Labeling for the product may be ing, 1920 Dayton Avenue, P.O. Box 844, required to contain information on the Ames, IA 50010. Requests must specify conditional status of the license. the restriction(s) being requested and [52 FR 11026, Apr. 7, 1987, as amended at 60 must explain why the restrictions are FR 48021; Sept. 18, 1995]

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PART 103—EXPERIMENTAL PRO- experimental biological products or DUCTION, DISTRIBUTION, AND live organisms. EVALUATION OF BIOLOGICAL (a) Surviving test animals (including challenged control animals) shall not PRODUCTS PRIOR TO LICENSING be removed from the premises on which the tests are conducted for at least 14 Sec. days after administration of an experi- 103.1 Preparation of experimental biological products. mental biological product or live orga- 103.2 Disposition of animals administered nisms: Provided, however, That this experimental biological products or live holding period may be increased or de- organisms. creased as permitted or requested by 103.3 Shipment of experimental biological the Administrator following review of products. all relevant information or data avail- AUTHORITY: 21 U.S.C. 151–159; 7 CFR 2.22, able. 2.80, and 371.4. (b) All animals administered experimental biological products which are § 103.1 Preparation of experimental bi- to be slaughtered at establishments ological products. subject to the Federal Meat Inspection Except as otherwise provided in this Act, as amended and extended (21 section, experimental biological prod- U.S.C. 601 et. seq.) are subject to the ap- ucts which are neither composed of nor plicable requirements of § 309.16 of this prepared with organisms or antigens title (Meat Inspection Regulations). used in biologicals already licensed, (c) Except as otherwise provided in shall not be prepared in the production this paragraph, the research investi- facilities of a licensed establishment. gator or research sponsor shall main- Upon application therefor, the Admin- tain adequate records relative to the istrator may authorize the preparation disposition of each animal adminis- of experimental products on the prem- tered experimental biological products. ises of a licensed establishment if he These records shall be maintained for a determines that such preparation will minimum period of two years from the not result in contamination of the li- date that an experimental product was censed products. Each request for per- administered to such animal, and shall mission to prepare an experimental bi- show the name and address of the ological product on licensed premises owner; number, species, class and loca- shall indicate the nature of the unli- tion of the animals; and if sold, the censed product, designate facilities to name and address of the consignee, be used, and specify precautions which buyer, commission, firm or abattoir: will be taken to prevent contamination Provided, however, That a research in- of licensed products. Such requests vestigator or research sponsor may be shall be submitted to the Adminis- exempted from these recordkeeping re- trator. Research facilities that are en- quirements by the Administrator on tirely separate and apart from facili- the basis of acceptable data dem- ties used for the preparation of licensed onstrating that use of the experimental biological products will not be consid- biological product will not result in the ered a part of the licensed premises for presence of any unwholesome condition purposes of this section. in the edible parts of animals subsequently presented for slaughter. (Approved by the Office of Management and Budget under control number 0579–0013) (Approved by the Office of Management and Budget under control number 0579–0059) [30 FR 11848, Sept. 16, 1965, as amended at 48 FR 57473, Dec. 30, 1983; 56 FR 66783, Dec. 26, [30 FR 11848, Sept. 16, 1965, as amended at 48 1991] FR 57473, Dec. 30, 1983; 56 FR 66783, Dec. 26, 1991; 66 FR 21063, Apr. 27, 2001] § 103.2 Disposition of animals administered experimental biological prod- § 103.3 Shipment of experimental bio- ucts or live organisms. logical products. Safeguards as herein provided shall Except as provided in this section, no be established by the research investi- person shall ship or deliver for ship- gator or research sponsor to control ment in or from the United States, the disposition of all animals administered District of Columbia, or any Territory

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of the United States any unlicensed bi- experimental biological product in ological product for experimental use meat animals is not likely to result in in animals. For the benefit of license the presence of any unwholesome con- applicants and to permit and encourage dition in the edible parts of animals research, a person may be authorized subsequently presented for slaughter. by the Administrator to ship unli- (g) A statement from the research in- censed biological products for the pur- vestigator or research sponsor agreeing pose of evaluating such experimental to furnish, upon the Administrator’s products by treating limited numbers request, additional information con- of animals, Provided, that, the Admin- cerning each group of meat animals in- istrator determines that the conditions volved prior to movement of these ani- under which the experiment is to be mals from the premises where the test conducted are adequate to prevent the is to be conducted. Such information spread of disease and approves the pro- shall include the owner’s name and ad- cedures set forth in the request for dress; number, species, class and loca- such authorization. Special restriction of animals involved; date ship- tions or tests may be imposed, espe- ment is anticipated; along with name cially in the case of products con- and address of consignee, buyer, com- taining live organisms, when they are mission firm or abattoir. deemed necessary or advisable by the (h) Any information the Adminis- Administrator. A request for author- trator may require in order to assess ization to ship an unlicensed biological the product’s impact on the environ- product for experimental study and ment. evaluation shall be accompanied by the [26 FR 7726, Aug. 18, 1961, as amended at 30 following: FR 11848, Sept. 16, 1965; 52 FR 30131, Aug. 13, (a) One copy of a permit or letter of 1987; 56 FR 66783, Dec. 26, 1991; 75 FR 20772, permission from the proper State or Apr. 21, 2010] foreign animal health authorities of each State or foreign country involved. PART 104—PERMITS FOR (b) Two copies of a tentative list of BIOLOGICAL PRODUCTS the names of the proposed recipients and quantity of experimental product Sec. that is to be shipped to each individual. 104.1 Permit required. In the event of subsequent changes, ad- 104.2 Permit authorized. ditional information shall be furnished 104.3 Permit application. when such facts are known; 104.4 Products for research and evaluation. (c) Two copies of a description of the 104.5 Products for distribution and sale. product, recommendations for use, and 104.6 Products for transit shipment only. results of preliminary research work; 104.7 Product permit. 104.8 Illegal shipments. (d) Two copies of labels or label sketches which show the name or iden- AUTHORITY: 21 U.S.C. 151–159; 7 CFR 2.22, tification of the product and bear a 2.80, and 371.4. statement, ‘‘Notice! For Experimental SOURCE: 38 FR 32916, Nov. 29, 1973, unless Use Only—Not For Sale,’’ or equiva- otherwise noted. lent. The U.S. Veterinary License legend shall not appear on such labels; § 104.1 Permit required. and Unless otherwise authorized or di- (e) Two copies of a proposed general rected by the Administrator, each per- plan covering the methods and proce- mit to import a biological product into dures for evaluating the product and the United States shall be issued in ac- for maintaining records of the quan- cordance with the regulations in this tities of experimental product pre- part. pared, shipped and used. At the conclu- (a) No biological product shall be sion of field studies, results shall be ob- brought into the United States unless a tained, summarized, and submitted to permit has been issued for such prod- the Animal and Plant Health Inspec- uct. A separate U.S. Veterinary Bio- tion Service. logical Product Permit shall be re- (f) Data acceptable to the Adminis- quired for each shipment of biological trator demonstrating that use of the product to be imported: Provided, That,

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a permit shall also be required for each Internet at (http://www.aphis.usda.gov/ transit shipment of biological products animallhealth/vetlbiologics/ moved through the United States. vblforms.shtml) and application for a (b) Each person importing biological permit to import a veterinary biologic products shall hold an unexpired, un- for research and evaluation or transit suspended, and unrevoked permit shipment may be made on the Internet issued by Animal and Plant Health In- at (http://www.aphis.usda.gov/ spection Service. Such person shall re- animallhealth/permits/ side within the United States, or oper- vetlbiolpermits.shtml). ate a business establishment within (b) The application shall specify the the United States, or both. type of permit required, the port of entry at which the product shall be [38 FR 32916, Nov. 29, 1973, as amended at 56 FR 66783, Dec. 26, 1991; 56 FR 66783, Dec. 26, cleared through Customs, the esti- 1991] mated quantity involved, and the anticipated date on which the importa- § 104.2 Permit authorized. tion shall be made. (a) Animal and Plant Health Inspec- (Approved by the Office of Management and tion Service is authorized to issue Budget under control number 0579–0013) three types of permits for importing bi- [38 FR 32916, Nov. 29, 1973, as amended at 48 ological products. They shall be: FR 57473, Dec. 30, 1983; 56 FR 66783, Dec. 26, (1) U.S. Veterinary Biological Prod- 1991; 75 FR 20772, Apr. 21, 2010] uct Permit for Research and Evalua- tion; § 104.4 Products for research and eval- (2) U.S. Veterinary Biological Prod- uation. uct Permit for Distribution and Sale; (a) An application for a U.S. Veteri- or nary Biological Product Permit to im- (3) U.S. Veterinary Biological Prod- port a biological product for research uct Permit for Transit Shipment Only. and evaluation shall be accompanied (b) A permit shall not be issued for a by a brief description of such product, biological product from countries methods of propagating antigens in- known to have exotic diseases, includ- cluding composition of medium, spe- ing but not limited to foot-and-mouth cies of animals or cell cultures in- disease, rinderpest, fowl pest (fowl volved, degree of inactivation or at- plague), swine vesicular disease, New- tenuation, recommendations for use, castle disease, and African swine fever, and the proposed plan of evaluation. if in the opinion of the Administrator, The applicant shall also provide any in- such products may endanger the live- formation the Administrator may re- stock or poultry of this country. quire in order to assess the product’s (c) A permit shall not be issued until impact on the environment. an inspector has determined the condi- (b)(1) A permit to import a biological tion of the equipment and facilities of product for research and evaluation the producer, of the applicant, or of shall not be issued unless the scientific both if such a determination is consid- capabilities of the investigator are de- ered necessary by the Administrator. termined to be adequate to safeguard (d) A permit shall not be issued for a domestic animals and protect public biological product prepared in the health, interest, or safety from any United States, exported, and presented deleterious effects which might result for reentry except as provided in from use of such product. Special re- § 104.4(d). strictions or tests may be specified as [38 FR 32916, Nov. 29, 1973, as amended at 56 part of the permit when they are FR 66783, Dec. 26, 1991; 56 FR 66783, Dec. 26, deemed necessary or advisable by the 1991] Administrator. (2) No person shall ship a product im- § 104.3 Permit application. ported under this section for research (a) Each person desiring to import a and evaluation anywhere in or from biological product shall make written the United States unless authorized by application to Animal and Plant the Administrator in accordance with Health Inspection Service for a permit. the provisions of § 103.3 of this sub- Application forms are available on the chapter.

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(c) A biological product shall not be matters pertaining to the preparation imported for Research and Evaluation of such product and that each biologi- which is not packaged and labeled in cal product shall be prepared in accord- accordance with § 112.9 of this sub- ance with the regulations applicable to chapter. the product or in a manner acceptable (d) When a licensed product has been to the Administrator so as to carry out exported from the United States, a per- the purposes of the Act. mit may be issued to the producer for (4) The methods to be used in the a small quantity of such product for in preparation of each biological product vitro Research and Evaluation tests: Provided, That, the importation of such shall be written into an approved Out- product will not endanger the livestock line of Production prepared in accord- or poultry of this country. ance with the applicable provisions of part 114 of this subchapter. Two copies (Approved by the Office of Management and of such Outlines of Production shall be Budget under control number 0579–0013) submitted to Animal and Plant Health [38 FR 32916, Nov. 29, 1973, as amended at 48 Inspection Service and be approved be- FR 57473, Dec. 30, 1983; 52 FR 30131, Aug. 13, fore the permit is issued. 1987; 56 FR 66783, Dec. 26, 1991] (5) Data shall be furnished by the ap- § 104.5 Products for distribution and plicant which establishes that the sale. product involved complies with the An application for a U.S. Veterinary provisions of the Act and the regula- Biological Product Permit to import a tions issued pursuant thereto. When biological product for Distribution and deemed necessary to obtain required Sale shall be accompanied by sup- information, Animal and Plant Health porting material necessary to satisfy Inspection Service may require that the requirements provided in this sec- the product be tested under field condition. tions within or outside the United (a) A permit shall not be issued un- States as the occasion demands. less the conditions under which the bi- (b) The permittee shall furnish the ological product is to be prepared or following: the methods to be used are such as to (1) Adequate facilities for storing all reasonably insure that the product is imported biological products. An in- pure, safe, potent, and efficacious. spection of such facilities shall be (1) Two copies of blueprints of the producing foreign establishment shall made by inspectors before a permit is be submitted with the application un- issued and additional inspections shall less satisfactory plans are on file with be made at any time subsequent to the Animal and Plant Health Inspection importation of the biological products Service from a previous application. if deemed necessary by the Adminis- The production facilities to be used for trator; each product prepared at the establish- (2) Information regarding all claims ment shall be designated. to be made on labels and advertising (2) The manufacturer shall submit matter used in connection with or rewritten authorization for properly ac- lated to the biological product to be credited inspectors to inspect without imported; previous notification, and at such (3) Mounted copies of final container times as may be demanded by the labels, carton labels, and enclosures to aforesaid inspectors, all parts of the es- be used with the imported product as tablishment in which biological prod- provided in part 112 of this subchapter; ucts shall be prepared, all processes of and preparation, and all records relative to (4) Samples of each serial from each such preparation. shipment of biological products im- (3) The manufacturer shall furnish written assurance that a biological ported or offered for importation. Such product to be imported for Distribution samples shall be collected, examined, and Sale shall be prepared under the and tested in a manner specified by the supervision of a person competent by Administrator. The biological products education and experience to handle all

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being sampled shall not be further dis- (c) A permit shall not be used after tributed by the permittee until re- the date specified. leased by Animal and Plant Health In- [38 FR 32916, Nov. 29, 1973, as amended at 56 spection Service. FR 66783, Dec. 26, 1991; 62 FR 13294, Mar. 20, 1997] (Approved by the Office of Management and Budget under control number 0579–0013) § 104.8 Illegal shipments. [38 FR 32916, Nov. 29, 1973, as amended at 48 (a) Biological products which are pre- FR 57473, Dec. 30, 1983; 49 FR 21044, May 18, sented for importation without a per- 1984; 56 FR 66783, Dec. 26, 1991; 75 FR 20772, mit having been issued shall be re- Apr. 21, 2010] turned to the country of origin at the § 104.6 Products for transit shipment expense of the importer or in lieu only. thereof, destroyed by Department personnel. An application for a permit for Tran- (b) Biological products for Distribu- sit Shipment Only shall be required tion and Sale presented for importa- when a biological product is being tion under a permit and found to be shipped from one foreign country to worthless, contaminated, dangerous, or another foreign country by way of the harmful shall, within a period of 30 United States. The shipment shall days after such finding, be returned to move under a permit subject to the fol- the country of origin at the expense of lowing restrictions: the importer or in lieu thereof, de- (a) The shipment shall be confined to stroyed by Department personnel: Pro- the carrier at all times when such ship- vided, That such product shall not be ment is to transit the United States on returned to the country of origin while the same carrier on which it arrived. If bearing a U.S. permit number on the the shipment is to be transferred to a label. carrier other than the one on which it shall arrive into the United States, a PART 105—SUSPENSION, REVOCA- schedule of arrival and departure of TION, OR TERMINATION OF BIO- each shipment shall be furnished by LOGICAL LICENSES OR PERMITS the permittee to Animal and Plant Health Inspection Service prior to ar- Sec. rival in the United States. 105.1 Suspension or revocation. (b) The permittee shall be responsible 105.2 Notification of infractions. to Animal and Plant Health Inspection 105.3 Notices re: worthless, contaminated, dangerous, or harmful biological prod- Service for handling, storing, and for- ucts. warding of the biological product. Ani- 105.4 Termination of licenses and permits mal and Plant Health Inspection Serv- for inactivity. ice shall be notified of all shipments AUTHORITY: 21 U.S.C. 151–159; 7 CFR 2.22, received and forwarded by the per- 2.80, and 371.4. mittee and an accurate accounting shall be made. § 105.1 Suspension or revocation. (Approved by the Office of Management and (a) An establishment license, product Budget under control number 0579–0013) license, or permit issued under the Virus-Serum-Toxin Act may be for- [38 FR 32916, Nov. 29, 1973, as amended at 48 mally suspended or revoked after op- FR 57473, Dec. 30, 1983; 56 FR 66784, Dec. 26, portunity for hearing has been ac- 1991; 61 FR 52873, Oct. 9, 1996] corded the licensee or permittee as pro- § 104.7 Product permit. vided in part 123 of this subchapter if the Secretary is satisfied that the li- (a) A permit shall be numbered and cense or permit is being used to facili- dated. tate or effect the preparation, sale, (b) The purpose for which the product barter, exchange, shipment, or impor- is imported shall be specified on the tation contrary to said Act of any permit as for Research and Evaluation, worthless, contaminated, dangerous, or Distribution and Sale, or Transit Ship- harmful biological product. Such use ment Only. may be found to exist if:

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(1) The construction of the establish- and the license for the product shall be ment in which the biological product is subject to suspension or revocation prepared is defective, or the establish- under the provisions of § 105.1(b). ment is not conducted as required by [42 FR 31430, June 21, 1977, as amended at 56 the regulations in parts 101 through 118 FR 66783, Dec. 26, 1991] of this subchapter; (2) The methods of preparation of the § 105.3 Notices re: worthless, contami- product are faulty, or the product con- nated, dangerous, or harmful bio- tains impurities or lacks potency; logical products. (3) The product is so labeled or adver- (a) If at any time it appears that the tised as to mislead or deceive the pur- preparation, sale, barter, exchange, chaser in any particular; shipment, or importation, as provided (4) The licensee, permittee, or the in the Virus-Serum-Toxin Act, of any foreign manufacturer has failed to biological product by any person hold- maintain and make available for ining a license or permit may be dan- spection records in connection with the gerous in the treatment of domestic development and preparation of prod- animals, the Secretary may without uct, has failed to provide complete and hearing notify the licensee or per- accurate information when requested, mittee, and pending determination of or has failed to provide complete and formal proceedings instituted under accurate information in the Outline of part 123 of this subchapter for suspen- Production or in reports and records; sion or revocation of the license or per- (5) The licensee or permittee has vio- mit insofar as it authorizes the manu- lated or failed to comply with any pro- facture or importation of the par- vision of the Virus-Serum-Toxin Act or ticular product, no person so notified the regulations in this subchapter; shall thereafter so prepare, sell, barter, (6) The license or permit is otherwise exchange, ship, deliver for shipment, or used to facilitate or effect the prepara- import such product. tion, sale, barter, exchange, shipment, (b) If a serial of biological product is or importation, contrary to the Virus- found to be unsatisfactory according to Serum-Toxin Act, of any worthless, applicable Standard Requirements, the contaminated, dangerous, or harmful Administrator may notify the licensee biological product. to stop distribution and sale of the se- (b) In case of willfulness or where the rial. public health, interest, or safety so re- (c) When notified to stop distribution quired the Secretary may, without and sale of a serial or subserial of a hearing, informally suspend such es- veterinary biological product under the tablishment license, product license, or provisions of paragraph (a) or (b) of permit upon the grounds set forth in this section, veterinary biologics li- paragraph (a) of this section pending censees or permittees shall: determination of formal proceedings (1) Stop the preparation, distribu- under part 123 of this subchapter for tion, sale, barter, exchange, shipment, suspension or revocation of the license or importation of the affected serial(s) or permit. or subserial(s) of any veterinary bio- [38 FR 23512, Aug. 31, 1973, as amended at 41 logical product pending further in- FR 44359, Oct. 8, 1976; 61 FR 52874, Oct. 9, 1996; structions from APHIS. 64 FR 43044, Aug. 9, 1999] (2) Immediately, but no later than 2 days, send stop distribution and sale § 105.2 Notification of infractions. notifications to any wholesalers, job- If an infraction of a requirement of a bers, dealers, foreign consignees, or product license is brought to the atten- other persons known to have any such tion of the licensee by written notifica- veterinary biological product in their tion thereof by Animal and Plant possession, which instruct them to stop Health Inspection Service, a subse- the preparation, distribution, sale, bar- quent violation of similar nature oc- ter, exchange, shipment, or importa- curring with the same licensed biologi- tion of any such veterinary biological cal product within 6 months of the said product. All notifications shall be doc- written notification shall be umented in writing by the licensee or primafacie evidence of willful violation permittee.

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(3) Account for the remaining quan- the supervision or control of the De- tity of each serial(s) or subserial(s) of partment in the prevention, control or any such veterinary biological product eradication of animal diseases in con- at each location in the distribution nection with (a) an official USDA pro- channel known to the manufacturer (li- gram; or (b) an emergency animal dis- censee) or importer (permittee). ease situation, or (c) a USDA experi- (4) When required by the Adminis- mental use of the product. trator, submit complete and accurate [45 FR 65184, Oct. 2, 1980, as amended at 56 FR reports of all notifications concerning 66783, Dec. 26, 1991] stop distribution and sale actions to the Animal and Plant Health Inspec- tion Service pursuant to § 116.5 of this PART 107—EXEMPTIONS FROM subchapter. PREPARATION PURSUANT TO AN UNSUSPENDED AND UNREVOKED (Approved by the Office of Management and Budget under control number 0579–0318) LICENSE

[38 FR 23512, Aug. 31, 1973, as amended at 56 Sec. FR 66783, Dec. 26, 1991; 72 FR 17798, Apr. 10, 107.1 Veterinary practitioners and animal 2007] owners. 107.2 Products under State license. § 105.4 Termination of licenses and permits for inactivity. AUTHORITY: 21 U.S.C. 151–159; 7 CFR 2.22, 2.80, and 371.4. (a) If a biological product has not been prepared by a licensee, or im- § 107.1 Veterinary practitioners and ported by a permittee for a period of 5 animal owners. years or more, the Administrator may Products prepared as provided in require the licensee to show intent to paragraphs (a) and (b) of this section resume production, or the permittee to and establishments in which such prod- show intent to resume importation, ucts are prepared, shall be exempt from within 6 months of notification. If the preparation pursuant to unsuspended licensee does not resume preparation, and unrevoked establishment and prod- or the permittee does not resume im- uct licenses. Persons exempt from li- portation, within 6 months of notifica- censure under this part shipping prod- tion, or within a mutually agreeable ucts which contain live organisms shall period, the product license, or permit, provide any information the Adminis- may be terminated by the Adminis- trator may require prior to shipment, trator. or at any other time deemed necessary, (b) When a license or permit is termi- in order to assess the products’ safety nated, the licensee or permittee shall and effect on the environment. The continue to be subject to the applicable shipment or delivery for shipment any- records provisions of § 116.8. where in or from the United States of [61 FR 52874, Oct. 9, 1996] any exempted product which is worthless, contaminated, dangerous, or PART 106—EXEMPTION FOR BIO- harmful is prohibited, and any person LOGICAL PRODUCTS USED IN DE- shipping such product, or delivering PARTMENT PROGRAMS OR such product for shipment, shall be UNDER DEPARTMENT CONTROL subject to sanctions under the Act. (a)(1) Products prepared by a veteri- OR SUPERVISION nary practitioner (veterinarian) solely for administration to animals in the AUTHORITY: 21 U.S.C. 151–159; 7 CFR 2.22, course of a State licensed professional 2.80, and 371.4. practice of veterinary medicine by such veterinarian under a veterinarian- § 106.1 Biological products; exemption. client-patient relationship and estab- The Administrator may exempt any lishments in which such products are biological product from one or more of prepared shall be exempt from licens- the requirements of this subchapter if ing under the Act and regulations. he determines that such product will Such a relationship is considered to be used by the Department or under exist when:

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(i) The veterinarian has assumed the (b) A request for exemption under responsibility for making medical this section must be made by the ap- judgments regarding the health of the propriate State authority and shall in- animal(s) and the need for medical clude information demonstrating that: treatment, and the client (owner or (1) The State has the authority to li- other caretaker) has agreed to follow cense viruses, serums, toxins, and anal- the instructions of the veterinarian; ogous products and establishments and when that produce such products; and (ii) There is sufficient knowledge of (2) The State has the authority to re- the animal(s) by the veterinarian to view the purity, safety, potency, and initiate at least a general or prelimi- efficacy of such products prior to re- nary diagnosis of the medical condition lease to the market; and of the animal(s). This means that the (3) The State has the authority to re- veterinarian has recently seen and is view product test results to assure personally acquainted with the keeping compliance with applicable standards and care of the animal(s), and/or by of purity, safety, and potency prior to medically appropriate and timely vis- release to the market; and its to the premises where the animal(s) (4) The State has the authority to are kept; and when deal effectively with violations of (iii) The practicing veterinarian is State law regulating viruses, serums, readily available for followup in case of toxins, and analogous products; and adverse reactions or failure of the regi- (5) The State effectively exercises the men. authority specified in paragraphs (b)(1) (2) Veterinarians preparing products through (4) of this section consistent subject to the exemption for products with the intent of the Act prohibiting under this section shall maintain and the preparation, sale, barter, exchange, make available for inspection by Ani- or shipment of worthless, contami- mal and Plant Health Inspection Serv- ice representatives or other Federal nated, dangerous, or harmful viruses, employees designated by the Secretary serums, toxins, or analogous products. such records as are necessary to estab- (c) Each product to be exempted and lish that a valid veterinarian-client-pa- each establishment preparing such tient relationship exists and that there product shall be identified by the State is a valid basis for the exemption under and the State shall give written notifi- this section. cation to the Administrator of each (b) Products prepared by a person such product and establishment. The solely for administration to animals State shall also give written notice to owned by that person shall be exempt the Administrator of each new license from the requirement that preparation issued and of each license terminated. be pursuant to an unsuspended and (d) In order to determine whether a unrevoked license. State exercises its authority with respect to biological products and estab- [52 FR 30131, Aug. 13, 1987, as amended at 56 lishments and whether its laws and FR 66783, Dec. 26, 1991] regulations are being achieved, the Ad- § 107.2 Products under State license. ministrator, in cooperation with proper State authorities, may conduct an on- (a) The Administrator shall exempt site evaluation of the State’s program from the requirement of preparation which may include inspection of estab- pursuant to an unsuspended and lishments and/or products to be in- unrevoked USDA establishment and cluded under the exemptions in this product license, any biological product section. prepared solely for distribution within the State of production pursuant to a [52 FR 30131, Aug. 13, 1987, as amended at 56 license granted by such State under a FR 66783, Dec. 26, 1991] program determined by the Adminis- trator to be consistent with the intent PART 108—FACILITY REQUIREMENTS of the Act to prohibit the preparation, FOR LICENSED ESTABLISHMENTS sale, barter, exchange, or shipment of worthless, contaminated, dangerous, or Sec. harmful biological products. 108.1 Applicability.

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108.2 Plot plans, blueprints, and legends re- (a) Reduce the entire premises to any quired. standard scale on one sheet of paper 108.3 Preparation of plot plans. which meets any of the American 108.4 Preparation of blueprints. standard trimmed sizes. Indicate the 108.5 Preparation of legends. scale used. 108.6 Revision of plot plans, blueprints, and legends. (b) Clearly mark the boundaries of 108.7 Filing of plot plans, blueprints, and the licensed premises and indicate legends. what marking denotes the boundaries. 108.8 Construction of buildings. Such boundaries shall coincide with 108.9 Dressing rooms and other facilities. some readily apparent perimeter line. 108.10 Outer premises and stables. Identify all fences, walls, or streets. 108.11 Water quality requirements. (c) Show buildings as reduced dimen- AUTHORITY: 21 U.S.C. 151–159; 7 CFR 2.22, sional drawings in the proper scale dis- 2.80, and 371.4. tance relationship with each other. SOURCE: 39 FR 16854, May 10, 1974, unless (d) Number, letter, or otherwise iden- otherwise noted. tify all buildings so that they may be correlated with the respective blue- § 108.1 Applicability. prints and legends. Unless otherwise authorized by the (e) Describe on the plot plan the use Administrator, all buildings, appur- of immediate adjacent properties such tenances, and equipment used in the as, residential area, pasture, box fac- preparation of biological products shall tory, or the like. be in compliance with the regulations (f) Show compass points. in this part. Each land area on which (g) Show date of preparation. such buildings and appurtenances are (h) Apply signature of responsible of- located shall be identified by an ad- ficial of the firm. dress which shall appear on the establishment license. § 108.4 Preparation of blueprints. [39 FR 16854, May 10, 1974, as amended at 56 (a) Blueprints, drawn to any suitable FR 66783, Dec. 26, 1991] scale, on regular blueprint paper or a good grade of white paper of any one of § 108.2 Plot plans, blueprints, and leg- the American standard trimmed sizes ends required. shall be acceptable: Provided, That the Each applicant for an establishment same scale shall be used for future revi- license shall prepare a plot plan show- sions unless the entire blueprint is re- ing all buildings for each particular vised. Indicate the scale used. land area, blueprints for each building (b) Use a single sheet of paper for used in the preparation of biological each floor of all buildings in which bio- products and legends containing a brief logical products are prepared. Illus- description of all activities in each trate in detail the areas in each build- room or area. ing utilized for such preparation. (c) If only a portion of a floor is used § 108.3 Preparation of plot plans. in the preparation of a biological prod- Plot plans shall show all of the build- uct, the blueprint shall illustrate the ings on a particular land area, whether entire floor in essentially the same de- or not they are all used for the prepa- tail throughout. All functions or ac- ration and initial shipping of biological tivities performed in the remainder of products: Provided, That, when a great the floor shall be indicated. number of buildings are on the same (d) Identify the floors if the drawing premises, only those surrounding the is not for all floors in a multiple-story buildings used for preparation and ini- building and identify activities on each tial shipping of biological products floor. shall be shown. The presence of the re- (e) Identify all rooms by letters or mainder of the buildings may be ac- numbers. counted for by a single statement de- (f) Show the location of important noting the total number of such build- stationary equipment by a suitable ings not used for the preparation or code which will be further identified on shipping of biological products. legends.

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(g) Explain on the blueprint or on the are not regarded as stationary but are legend, by a statement or listing, maintained in certain rooms. which rooms are equipped with water [39 FR 16854, May 10, 1974, as amended at 40 outlets, drains, and lighting. Show the FR 51413, Nov. 5, 1975; 50 FR 50764, Dec. 12, location of doors and windows. 1985] (h) Show compass points. (i) Show building number. § 108.6 Revision of plot plans, blue- (j) Show date of preparation. prints, and legends. (k) Apply signature of responsible of- Preliminary drawings may be sub- ficial of firm. mitted to Animal and Plant Health In- spection Service for comment prior to § 108.5 Preparation of legends. construction of new facilities or when A brief description of the activities remodeling is anticipated, old facilities performed in each room or area shall are to be torn down, or other changes be prepared as provided in this section affecting the workflow are to be made. and shall be referred to as a legend. The licensee shall: Legends shall be provided for each plot (a) Prepare revised plot plans, blue- plan and each blueprint or drawing. All prints, or legends and submit to Ani- pages of the legends shall be numbered, mal and Plant Health Inspection Serv- identified with corresponding plot plan ice for review and filing when changes or blueprint, and submitted in booklet have been completed. Also prepare a form either stapled together or clipped statement to accompany each revision into a suitable folder. to identify, by date of the superseded (a) Plot plan legends shall show the item, what is being superseded. following: (b) Prepare a drawing of the revised (1) Number of each building and the rooms, unit, or section to the same functions performed in each: Provided, scale as the blueprint on file which That if it is a multiple-story building shall be stamped and applied to the ex- in which biological products are pre- isting blueprint. If changes are numer- pared or handled, briefly describe func- ous, prepare a new blueprint. tions performed on each floor. (c) Drawings of new buildings may be (2) A practical and nontechnical de- added to existing plot plans. Indicate scription of construction materials the distance from surrounding build- used throughout those buildings used ings and boundary lines. entirely or partially for production and (d) Any change prescribed in this sec- handling of biological products. tion shall necessitate a change in one (b) Blueprint legends shall show the or more pages of the respective leg- following: ends. The revised pages shall carry the (1) A listing of all rooms by identi- same numbers as superseded pages. fying letters or numbers and the frac- [39 FR 16854, May 10, 1974, as amended at 56 tions prepared in each. Exceptions may FR 66783, Dec. 26, 1991] be listed for general purpose areas or rooms. Functions performed in each § 108.7 Filing of plot plans, blueprints, area and room shall be described, and legends. whether the licensed or unlicensed Two copies of all plot plans, blue- products. In rooms where products are prints, and legends, including revi- exposed to the surroundings, a descrip- sions, shall be submitted to Animal tion of decontamination procedures and Plant Health Inspection Service and other precautions against cross for review and filing. When the re- contamination shall be included. viewer takes exception to a submitted (2) A listing of the coded stationary item, such item shall be returned with equipment. appropriate comments for correction (3) A general listing of other essen- and resubmission. Acceptable submis- tial biological equipment such as mills, sions shall be stamped as filed and the centrifuges, mixing tanks, bottling and date noted. One stamped copy shall be sealing equipment, and the like, which returned and two copies retained for

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Animal and Plant Health Inspection ing hot and cold running water, soap, Service files. towels, and the like. They shall be in [39 FR 16854, May 10, 1974, as amended at 56 sufficient number, ample in size, con- FR 66783, Dec. 26, 1991; 75 FR 20772, Apr. 21, veniently located, properly ventilated, 2010] and meeting all requirements as to sanitary construction and equipment. § 108.8 Construction of buildings. (a) These rooms and facilities shall (a) The floors, walls, ceilings, parti- be separate from rooms or compart- tions, posts, doors, and all other parts ments in which biological products are of all structures, rooms, or facilities prepared, handled, or stored. used for the preparation of biological (b) These rooms and facilities shall products or ingredients of biological be so located in the establishment as to products at licensed establishments be readily accessible to all persons shall be of such material, construction, without having to enter or pass and finish as may be readily and thor- through biological products prepara- oughly cleaned. tion areas. (b) All rooms used in connection with the preparation of biological products § 108.10 Outer premises and stables. shall be so constructed and arranged as to prevent cross-contamination of such (a) The outer premises of licensed es- biological products. Halls or walkways tablishments, embracing docks, drive- shall be provided for the movement of ways, approaches, yards, pens, chutes, personnel or materials to each biologi- and alleys shall be drained properly cal products preparation area without and kept in a clean and orderly condi- going through another such area. tion. No nuisance shall be allowed in (c) Rooms or compartments separate any licensed establishment or on its from the remainder of the establish- premises. ment shall be provided at licensed es- (b) Stables or other premises for ani- tablishments for preparing, handling, mals used in the production or testing and storing virulent or dangerous of biological products at licensed es- microorganisms and products. tablishments shall be properly venti- (d) All rooms and compartments at lated and lighted, appropriately licensed establishments shall have an drained and guttered, and kept in sani- adequate air handling system to supply tary condition. proper ventilation sufficient to insure (c) Every practical precaution shall sanitary and hygienic conditions for be taken to keep licensed establish- the protection of the products and per- ments free of flies, rats, mice, and sonnel. other vermin. The accumulation, on (e) The supply of hot and cold water the premises of an establishment, of at licensed establishments shall be any material in which flies or other ample and clean. Adequate facilities vermin may breed is forbidden. Suit- shall be provided for the distribution of able arrangements, in keeping with the water in each establishment and for local health practices, shall be made the washing of all containers, machin- for the disposal of all refuse. ery, instruments, other equipment, and animals used in the preparation of a bi- § 108.11 Water quality requirements. ological product. A certification from the appropriate (f) There shall be an efficient drain- water pollution control agency, that age and plumbing system for each li- the establishment is in compliance censed establishment and premises with applicable water quality control thereof, and all drains and gutters standards, pursuant to section 401 of shall be properly installed with ap- the Federal Water Pollution Control proved traps and vents. Act, as amended (86 Stat. 877; 33 U.S.C. § 108.9 Dressing rooms and other fa- 1341), shall be filed with Animal and cilities. Plant Health Inspection Service for Each licensed establishment shall each licensed establishment. have dressing rooms, toilet facilities, [39 FR 16854, May 10, 1974, as amended at 56 and lavatory accommodations, includ- FR 66783, Dec. 26, 1991]

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PART 109—STERILIZATION AND § 109.3 Pasteurizers. PASTEURIZATION AT LICENSED All pasteurizing equipment shall ESTABLISHMENTS meet the requirements in paragraphs (a), (b), and (c) of this section and be Sec. acceptable to Animal and Plant Health 109.1 Equipment and the like. Inspection Service. 109.2 Sterilizers. (a) Metal serum containers shall be 109.3 Pasteurizers. used in licensed establishments. During AUTHORITY: 21 U.S.C. 151–159; 7 CFR 2.22, the heating process, each container 2.80, and 371.4. shall be surrounded by a separate water jacket or equivalent so that the § 109.1 Equipment and the like. entire container, including its lid, is (a) All containers, instruments, and heated to the required temperature. other apparatus and equipment, before Each serum container shall be equipped being used in preparing, handling, or with a motor-driven agitator and a sep- storing biological products, at a li- arate automatic recording thermom- censed establishment, except as other- eter. wise prescribed herein, shall be thor- (b) Each water bath shall have an oughly sterilized by live steam at a automatic temperature control to temperature of at least 120 °C. for not limit the temperature of the water to a less than one-half hour, or by dry heat maximum of 62 °C., an automatic re- at a temperature of at least 160 °C. for cording thermometer, an indicating not less than one hour. If for any rea- thermometer set in a fixed position, son such methods of sterilization are and circulating mechanism adequate to impracticable, then a process known to insure equal temperatures throughout be equally efficacious in destroying the bath. The heating unit for the bath microorganisms and their spores may shall be separated from the serum con- be substituted after approval by the tainer and the water jacket. Administrator. (c) Accurate thermometers at li- (b) Instruments which are found to be censed establishments shall be used at damaged by exposure to the degree of frequent intervals to check tempera- heat prescribed in this section, after tures of the serum as registered by re- having been thoroughly cleaned, may cording thermometers. be sterilized by boiling for not less [35 FR 16039, Oct. 13, 1970, as amended at 56 than 15 minutes. FR 66783, Dec. 26, 1991] [23 FR 10051, Dec. 23, 1958, as amended at 34 FR 18119, Nov. 11, 1969; 56 FR 66783, Dec. 26, PART 112—PACKAGING AND 1991] LABELING § 109.2 Sterilizers. Sec. Steam and dry-heat sterilizers used 112.1 General. in connection with the processing of bi- 112.2 Final container label, carton label, ological products at licensed establish- and enclosure. ments shall be equipped with auto- 112.3 Diluent labels. matic temperature recording gauges: 112.4 Subsidiaries, divisions, distributors, Provided, That other record keeping and permittees. systems may be used when approved by 112.5 Review and approval of labeling. the Administrator. When gauges are 112.6 Packaging biological products. used, they shall be periodically stand- 112.7 Special additional requirements. ardized to assure accuracy. Charts and 112.8 For export only. other temperature records made during 112.9 Biological products imported for reproduction shall be available at all search and evaluation. times charts and records shall be kept 112.10 Special packaging and labeling. in accordance with part 116 of this AUTHORITY: 21 U.S.C. 151–159; 7 CFR 2.22, chapter. 2.80, and 371.4.

[35 FR 16039, Oct. 13, 1970, as amended at 56 SOURCE: 38 FR 12094, May 9, 1973, unless FR 66783, Dec. 26, 1991] otherwise noted.

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§ 112.1 General. name shall be identical with that shown in the product license under (a) Unless otherwise authorized or directed by the Administrator, each bio- which such product is prepared, or the logical product prepared at a licensed permit under which it is imported, establishment, or imported, shall be shall be prominently lettered and packaged and labeled as prescribed in placed giving equal emphasis to each this part before it is removed from the word composing it. Descriptive terms licensed establishment or presented for used in the true name on the product importation: Provided, That biological license or permit shall also appear. Ab- products to be imported for research breviations of the descriptive terms and evaluation shall be subject to may be used on the final container packaging and labeling requirements label if complete descriptive terms ap- in § 112.9. Provided further, That, unless pear on a carton label and enclosures; otherwise exempted, all preparation, (2) If the biological product is pre- including packaging and labeling, of bi- pared in the United States, the name ological products shall only be per- and address of the producer (licensee or formed in a licensed establishment subsidiary) or if the biological product under an approved Outline of Produc- is prepared in a foreign country, the tion. name and address of the permittee and (b) No person shall apply or affix to of the foreign producer. or include with, or cause to be applied (3) The license or permit number as- or affixed to or included with, any car- signed by the Department which shall ton or final container of a biological be shown only in one of the following product, any label, stamp, mark or forms respectively: ‘‘U.S. Veterinary statement that is false or misleading in License No. lll,’’ or ‘‘U.S. Vet. Li- any particular, is not in compliance cense No. lll,’’ or ‘‘U.S. Vet Lic. No. with the regulations, or is not ap- lll,’’ or ‘‘U.S. Veterinary Permit No. proved by APHIS. lll,’’ or ‘‘U.S. Permit No. lll.’’ (c) No person shall alter, mark or remove any approved labeling affixed to (4) Storage temperature rec- or included with any biological product ommendation for the biological prod- ° prior to selling or otherwise distrib- uct stated as not over 45 F. or stated ° uting such product. In addition, no per- as not over 7 C. or stated as not over ° ° son shall mark any carton, other con- 45 F. or 7 C. tainer, or final container of a biologi- (5) Full instructions for the proper cal product so as to falsify the labeling, use of the product, including vaccina- make it misleading, or cause it to be il- tion schedules, warnings, cautions, and legible. the like: Provided, That in the case of (d) Labels that are stamped, printed very small final container labels or or glued directly on cartons, other con- carton, a statement as to where such tainers, or final containers shall be leg- information is to be found, such as ible throughout the dating period. Bio- ‘‘See enclosure for complete direc- logical products bearing labels, which tions,’’ ‘‘Full directions on carton,’’ or have been altered, mutilated, de- comparable statement; stroyed, obliterated or removed, shall (6) In the case of a multiple-dose be withheld from the market. final container, a warning to use entire [38 FR 12094, May 9, 1973, as amended at 59 contents when first opened: Provided, FR 43445, Aug. 24, 1994] That a diagnostic or a desensitizing antigen packaged in a multiple-dose § 112.2 Final container label, carton final container is exempt; label, and enclosure. (7) If the biological product contains (a) Unless otherwise provided, final viable or dangerous organisms or vi- container labels, carton labels, and en- ruses, a warning to ‘‘Burn this con- closures (inserts, circulars, or leaflets) tainer and all unused contents,’’ except shall include the information specified that in the case of a small one-dose in this section. container, the statement ‘‘Burn this (1) The principal part of the true container’’ or ‘‘Burn this vial’’ may be name of the biological product which used.

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(8) In the case of a biological product leading and may include factual state- recommended for use in domestic ani- ments regarding variable response of mals, the edible portion of which may different animals when vaccinated as be used for food purposes, a with- directed but may not include dis- holding statement of not less than 21 claimers of merchantability, fitness for days to read: ‘‘Do not vaccinate within the purpose offered, or responsibility (insert number) days before slaughter’’ for the product. or ‘‘Do not vaccinate food-producing (c) Labels of biological products pre- animals within (insert number) days pared at licensed establishments or im- before slaughter’’: Provided, That ported shall not include any statement, longer periods shall be stated when design, or device, which overshadows deemed necessary by the Adminis- the true name of the product as li- trator. Very small final container la- censed or which is false or misleading bels are exempted from this require- in any particular or which may other- ment. wise deceive the purchaser. (9) The following information shall (d) Carton labels and enclosures shall appear on the final container label and be subject to paragraph (d)(1), (d)(2), carton label, if any, but need not ap- and (d)(3) of this section. pear on the enclosure: (1) The statement, ‘‘Restricted to use (i) A permitted expiration date; by or under the direction of a veteri- (ii) The number of doses where appli- narian’’ or ‘‘Restricted to use by a vet- cable; erinarian,’’ shall be used on all carton (iii) The recoverable quantity of the labels and enclosures when such re- content of each final container stated striction is prescribed on the product in cubic centimeters (cc.) or milliliters license. (ml.) or units. (2) If the licensee states on the car- (iv) A serial number by which the ton labels and enclosures of a product product can be identified with the man- that its sales are restricted to veteri- ufacturer’s records of preparation: Pro- narians, then the entire production of vided, That when a liquid antigenic that particular product in the licensed fraction is to be used instead of a water establishment shall be so restricted by diluent for one or more desiccated an- the licensee. tigenic fractions in a combination (3) The statement ‘‘For veterinary package, a hyphenated serial number use only’’ or an equivalent statement composed of a serial number for the may appear on the carton labels and desiccated fraction and the serial num- enclosures for a product if such state- ber for the liquid fraction shall be used ment is being used to indicate that the on the carton; product is recommended specifically (10) In the case of a product which for animals, and not for humans. contains an antibiotic added during the (e) When label requirements of a for- production process, the statement eign country conflict with the require- ‘‘Contains lll as a preservative,’’ or ments as prescribed in this part, spe- an equivalent statement indicating the cial labels may be approved for use on antibiotic added shall appear on car- biological products to be exported to tons and enclosures if used: Provided, such country. When laws, regulations, That if cartons are not used, such in- or other requirements of foreign coun- formation shall appear on the final tries require exporters of biological container label; products prepared in a licensed estab- (11) The number of final containers of lishment to furnish official certifi- biological product and the number of cation that such products have been doses in each final container shall be prepared in accordance with the Virus- stated on each carton label for all car- Serum-Toxin Act and regulations tons containing more than one final issued pursuant thereto, such certifi- container of biological product. The cation may be made by Animal and number of final containers of diluent, if Plant Health Inspection Service upon any, and the quantity in each shall request of the licensee. also be stated on each carton label. (f) If a carton label or an enclosure is (b) Labels may also include any other required to complete the labeling for a statement which is not false or mis- multiple-dose final container of liquid

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biological product, only one final con- container’’ or ‘‘Burn this vial’’ may be tainer shall be packaged in each car- used. ton: Provided, That if the multiple-dose (g) The establishment license number final container is fully labeled without or the permit number, as the case may a carton label or enclosure, two or be, in one of the forms provided in more final containers may be packaged § 112.2(a)(3). in a single carton which shall be considered a shipping box. Labels or stick- [38 FR 12094, May 9, 1973; 38 FR 13476, May 22, ers for shipping boxes shall not contain 1973, and amended at 39 FR 16856, May 10, false or misleading information but 1974] need not be submitted for approval. § 112.4 Subsidiaries, divisions, dis- (Approved by the Office of Management and tributors, and permittees. Budget under control number 0579–0013) Labels used by subsidiaries, divi- [38 FR 12094, May 9, 1973, as amended at 39 sions, distributors, and permittees FR 16856, May 10, 1974; 41 FR 44359, Oct. 8, shall be affixed by the licensee in a li- 1976; 42 FR 11825, Mar. 1, 1977; 42 FR 29854, censed establishment where the prod- June 10, 1977; 42 FR 41850, Aug. 19, 1977; 48 FR uct is produced. Such labels shall com- 57473, Dec. 30, 1983; 56 FR 66784, Dec. 26, 1991] ply with requirements for their review, § 112.3 Diluent labels. approval, and filing as provided in the Each final container of diluent, other regulations. than a liquid biological product, pack- (a) Subsidiaries. Labels to be used on aged with desiccated biological prod- a licensed biological product prepared ucts shall bear a label that includes the by a subsidiary operating in a licensed following: establishment shall be submitted in ac- (a) The name—Sterile Diluent. cordance with § 112.5. Only labels ap- (b) True name of the biological prod- proved for use on such product shall be uct with which the diluent is packaged, used by the subsidiary. except that when the firm packages all (b) Divisions. Labels to be used on a desiccated biological products with the licensed biological product prepared in same diluent, or two or more types of a licensed establishment for distribu- diluent are used, and the licensees’ tion by a division or marketing unit of methods of identification and storage the licensee shall be submitted in ac- insure that all products are packaged cordance with § 112.5. The name, ad- with the correct type of diluent, labels dress, and license number of the li- affixed to the containers of diluent are censee shall be prominently placed on exempt from this provision. such labels. The relationship of the di- (c) The recoverable quantity of con- vision or marketing unit to the li- tents in cubic centimeters (cc) or milli- censee shall appear prominently on the liters (ml). label by use of the term ‘‘division of’’ (d) A serial number by which the dil- or equivalent. uent can be identified with the manu- (c) Distributors. The name and address facturer’s records of preparation; of the distributor or any statement, de- (e) Name and address of the licensee sign, or device shall not be placed on or the permittee; the labels or containers of a licensed (f) In the case of a diluent with which biological product in a manner which a desiccated biological product is to could be false or misleading or which come in contact while the diluent is in could indicate that the distributor is its original container; and, the manufacturer of such product or (1) Is in a multiple-dose container, a operating under the license number positive warning that all of the biologi- shown on the label. The manufacturer cal product shall be used at the time shall be identified by name, address, the container is first opened; and/or and license number with the term (2) The biological product is com- ‘‘manufactured by,’’ ‘‘produced by,’’ or posed of viable or dangerous organisms an equivalent term prominently placed or viruses, the notice, ‘‘Burn this con- in connection therewith. The name and tainer and all unused contents,’’ except address of the distributor may be that, in the case of a small one-dose placed on labels or containers if the container, the statement ‘‘Burn this term ‘‘distributor,’’ or ‘‘distributed

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by,’’ or an equivalent term is promi- (c)(1) Labels must be submitted to nently placed in connection therewith. the Animal and Plant Health Inspec- (d) Permittees. The name and address tion Service for review and written ap- of the permittee and any statement, proval. Only labels which are approved design, or device shall not be placed on as provided in § 112.5(d) may be used. the labels or containers of a biological When changes are made in approved la- product imported for sale and distribu- bels, the new labels shall be subject to tion in accordance with § 104.5 in a review and approval before use: Pro- manner which could be false or mis- vided, That certain minor changes may leading or which could falsely indicate be made in labels for products with ap- that the permittee is the manufacturer proved labels or master labels, and the of such product. The manufacturer revised labels may be used prior to re- shall be identified by name and address view by APHIS, with the provision that with the term ‘‘manufactured by,’’ a new label or master label bearing ‘‘produced by,’’ or an equivalent term these changes is submitted to APHIS prominently placed in connection for review and written approval within therewith. Reference to the permittee 60 days of label use, and that such shall be made by name, address, and minor changes do not render the prod- permit number with the term ‘‘im- uct mislabeled or the label false and ported by,’’ ‘‘produced for,’’ or an misleading in any particular. equivalent term prominently placed in (2) Minor label changes that may be connection therewith. made under the provision for products [50 FR 46417, Nov. 8, 1985, as amended at 59 with approved labels or master labels FR 43445, Aug. 24, 1994] are: (i) Changes in the physical dimen- § 112.5 Review and approval of label- sions of the label provided that such ing. change does not affect the legibility of Labels used with biological products the label; prepared at licensed establishments or (ii) Change in the color of label print, imported for general distribution and provided that such change does not af- sale must be submitted to the Animal fect the legibility of the label; and Plant Health Inspection Service (iii) The addition or deletion of a for review for compliance with the reg- Trade Mark (TM) or Registered (R) ulations and approval in writing prior symbol; to use, except as provided in paragraph (iv) The correction of typographical (c) of this section and under the master errors; label system provided in paragraph (d) (v) Adding or changing label control of this section. numbers of bar codes; and (a) Transmittal forms, available on (vi) Revising or updating logos. the Internet at (http:// (d) Labels and sketches submitted www.aphis.usda.gov/animallhealth/ shall be prepared in the number and vetlbiologics/vblforms.shtml), shall be manner prescribed in this paragraph. used with each submission of sketches (1) Copies required: (including proofs) and labels. Separate (i) For label sketches, submit two forms shall be used for each biological copies of each sketch of a final con- product but only one copy of the form tainer label, carton label, and enclo- shall be used for all sketches and labels sure. Sketches must be legible, and submitted at the same time for the must include all information specified same biological product. in § 112.2. One copy of each sketch will (b) Sketches may be submitted for be returned with applicable comments, comment to Animal and Plant Health and one copy will be held on file by Inspection Service by the licensee or APHIS for no more than one year after permittee before preparing the finished processing, until replaced by a finished label. Such sketches shall be returned label: Provided, That sketches sub- to the licensee or permittee with committed in support of an application for ments, if any. Failure of the reviewer a license or permit shall be held as long to take exception to a sketch shall not as the application is considered active. constitute approval of a finished label (ii) For master label sketches, sub- subsequently prepared. mit for each product two copies of each

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sketch of an enclosure, label for the (i) Each label or sketch shall be se- smallest size final container, and car- curely fastened to a separate sheet of ton label; Provided, That labels for heavy bond paper (81⁄2″ × 11″) in such a larger size containers and/or cartons manner that all information is avail- that are identical, except for physical able for review. dimensions, need not be submitted. One (ii) Two-or three-part cartons, in- copy of each master label sketch will cluding ‘‘sleeves,’’ shall be considered be returned with applicable comments, as one label. All parts shall be sub- and one copy will be held on file by mitted together. APHIS for one year after processing, (iii)(A) When two final containers are until replaced by a finished master packaged together in a combination label that is submitted according to package, the labels for each shall be § 112.5(d)(1)(iii): Provided, That master mounted on the same sheet of paper label sketches submitted in support of and shall be treated as one label. For an application for license or permit diagnostic test kits, the labels for use shall be held as long as the application on the individual reagent containers to is considered active. be included in the kit shall be mounted (iii) For finished labels, submit two together on a single sheet of paper, if copies of each finished final container possible; if necessary, a second sheet of label, carton label, and enclosure: Pro- paper may be used. The carton label vided, That when an enclosure is to be and enclosure shall be mounted on separate individual sheets. used with more than one product, one (B) If either final container label is extra copy shall be submitted for each also used alone or in another combina- additional product. One copy of each tion package, sets of separate labels for finished label will be retained by each biological product with which it is APHIS. One copy will be stamped and used shall be submitted for review. returned to the licensee. Labels to (iv) When the same final container which exceptions are taken shall be label is applied by different methods marked as sketches and handled under such as paper or screen printing, one of § 112.5(d)(1)(i). each shall be mounted on the same (iv) For finished master labels, sub- sheet of paper as one submission. mit for each product two copies each of (3) To appear on the top of each page: the enclosure and the labels for the (i)(A) Name and product code number smallest size final container and car- of the biological product as it appears ton. Labels for larger sizes of con- on the product license or permit. tainers or cartons of the same product (B) Extra copies of enclosures to be that are identical, except for physical used with another product shall bear dimensions, need not be submitted. the name and code number of the prod- Such labels become eligible for use, uct affected. concurrent with the approval of the ap- (ii)(A) Designation of the specimen as propriate finished master label: Pro- a label or master label: sketch, final vided, That the marketing of larger container label, carton label, or enclo- sizes of final containers is approved in sure. the filed Outline of Production, and the (B) If two final container labels or appropriate larger sizes of containers multiple parts are on one sheet, each or cartons are identified on the label shall be named, and the label or part mounting sheet. When a master label being revised shall be designated. enclosure is to be used with more than (iii) Size of package (dose, ml., cc., or one product, one extra copy for each units) for which the labels or enclo- additional product shall be submitted. sures are to be used. One copy of each finished master label (4) To appear on the bottom of each will be retained by APHIS. One copy page: The reason for and information will be stamped and returned to the li- relevant to the submission shall be censee. Master labels to which excep- stated in the lower left hand corner as: tions are taken will be marked as (i) Master label dose sizes approved sketches and handled under for code llllll. § 112.5(d)(1)(ii). (ii) Replacement for label, master (2) Mounting: label, and/or sketch No. llllll.

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(iii) Reference to label or master certain minor differences permitted in label No. llllll. accordance with § 112.5(c). (iv) Addition to label No. llllll. (Approved by the Office of Management and (v) License Application Pending Budget under control number 0579–0013) llllll. [38 FR 12094, May 9, 1973, as amended at 48 (vi) Foreign Language copy of Label FR 57473, Dec. 30, 1983; 49 FR 21044, May 18, No. llllll. 1984; 56 FR 66783, Dec. 26, 1991; 59 FR 43445, (e) Special requirements for foreign Aug. 24, 1994; 61 FR 29464, June 11, 1996; 61 FR language labels: 33175, June 26, 1996; 64 FR 43044, Aug. 9, 1999; 75 FR 20772, Apr. 21, 2010] (1) If true, a statement that the label is a direct translation from a cor- § 112.6 Packaging biological products. responding approved domestic label. (a) Each multiple-dose final con- (2) If the foreign language label is not tainer of a biological product which re- a direct translation of an approved do- quires a diluent for administration mestic label, an English version shall shall be packaged in an individual car- be submitted with an explanation for ton with a container of the proper vol- the difference in texts. ume of diluent for that dose as speci- (3) Foreign language portion of a bi- fied in the filed Outline of Production. lingual label shall be a true translation Each multiple-dose final container of a of the English portion. Reference to ad- product which does not require a dil- ditional information on the enclosure uent for administration need not be shall not be made unless that enclosure packaged in an individual carton un- is also bilingual. less the final container labeling does (f) When a request is received from not contain all information required by Animal and Plant Health Inspection the regulations. Such information Service, the licensee or permittee shall must be included in or on a carton. Ex- ceptions are provided in paragraphs (c) submit a list of all approved labels cur- and (d) of this section and § 112.8. rently being used. Each label listed (b) Single-dose final containers of a shall be identified as to: product need not be packaged one per (1) Name and product code number as carton. For single-dose products which it appears on the product license or require a diluent for administration, permit for the product; and the number of containers of the proper (2) Where applicable, the size of the amount of diluent specified in the filed package (doses, ml., cc., or units) on Outline of Production for the number which the label shall be used; and of doses contained in the carton shall (3) Label number and date assigned; be included in each carton. and (c) Poultry products for mass admin- (4) Name of licensee or subsidiary ap- istration (including but not limited to pearing on the label as the producer. administration through drinking water (g) At the time of an inspection, or and spray) and products used in auto- when requested by APHIS, licensees or matic vaccinating systems (including permittees shall make all labels and but not limited to pneumatic beak master labels, including labels ap- injectors and automated needle injectors) may be packaged in mul- proved for use but exempted from filing tiple-dose final containers as specified under the master label system, avail- in the filed Outline of Production. able for review by authorized inspec- Poultry products for manual adminis- tors. Such labels shall be identical to tration to individual birds shall not ex- the approved label or master label exceed 1,000 doses in each final container. cept for physical dimensions, reference Diluent need not be packaged with the to recoverable volume or doses and/or final container(s) of the product, but the licensee shall provide the required number of containers of diluent as specified in the filed Outline of Produc- tion. The following requirements apply to cartons containing more than one final container of poultry product:

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(1) They shall be sealed prior to leav- flammation of the eyelids of humans, ing the licensed establishment. and a warning to the user to avoid in- (2) The contents may not be repack- fecting his eyes shall be included on aged. the enclosure. (3) The contents of such cartons may (b) In the case of a biological product not be sold in fractional units. containing infectious bronchitis virus, (4) The following statement must ap- all labels shall show the infectious pear in a prominent place on the car- bronchitis virus type or types used in ton label: ‘‘Federal regulations pro- the product. Abbreviation is permitted. hibit the repackaging or sale of the (c) In the case of a biological product contents of this carton in fractional containing inactivated rabies virus, units. Do not accept if seal is broken.’’ carton labels, enclosures, and all but (d) Diluent for the following products very small final container labels shall need not be packaged with the final include a warning against freezing and container(s) of the product, but the li- the recommendations provided in this censee shall provide the consumer with paragraph. the required number of containers of (1) That vaccine be administered to the proper amount of diluent as speci- animals at 3 months of age or older, fied in the filed Outline of Production: with a repeat dose 1 year later. (1) Marek’s Disease Vaccine. (2) Subsequent revaccination as de- (2) Poultry vaccines administered to termined from the results of duration individual birds using automatic vacci- of immunity studies conducted as pre- nating equipment. scribed in § 113.209, paragraph (b) or (c), (e) Final containers of biological or both. product prepared at a licensed estab- (d) In the case of a biological product lishment, or imported, in cartons or containing modified live rabies virus, other containers shall not be removed the carton labels, enclosures, and all from such cartons or containers for but very small final container labels sale or distribution, unless each final shall include the recommendations container bears, or is packaged in a provided in this paragraph. carton with, complete and approved la- (1) For low egg-passage (below the beling which is affixed to or included 180th egg-passage level) the statement with each container by the licensed es- ‘‘For Use in Dogs Only! Not For Use in tablishment producing the product or Any Other Animal!’’ by the producer in the case of imported (2) For other vaccines containing product: Provided, That this paragraph modified live rabies virus, the state- is not intended to apply to licensed ment ‘‘For Use In (designate animal(s)) veterinary practitioners administering Only! Not For Use In Any Other Ani- or dispensing biological products in the mal!’’ course of their practice under a veteri- (3) Intramuscular injection at one nary-client-patient-relationship as site in the thigh shall be recommended. that term is used in § 107.1. (4) The statement ‘‘In event of acci- (f) Labels which are affixed to or in- dental exposure to the vaccine virus, cluded with a biological product shall the possible hazard to human health not be removed or altered in any man- should be considered and State Public ner. Health Officials should be consulted for [47 FR 8761, Mar. 2, 1982, as amended at 48 FR specific recommendations’’ shall be 12691, Mar. 28, 1983; 59 FR 43445, Aug. 24, 1994; prominently placed on all carton labels 64 FR 43044, Aug. 9, 1999] and on enclosures, if used. (5) That vaccine be administered to § 112.7 Special additional require- animals at 3 months of age or older, ments. with a repeat dose 1 year later. The label requirements in this sec- (6) Subsequent revaccination as de- tion are additional to those prescribed termined from the results of duration elsewhere in this part. of immunity studies conducted as pre- (a) In the case of biological products scribed in § 113.312, paragraph (b) or (c), containing live Newcastle Disease or both. virus, a caution statement indicating (e) In the case of bovine that Newcastle Disease can cause in- rhinotracheitis vaccine containing

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modified live virus, all labeling except except that if the animal is less than 12 small final container labels shall bear weeks of age, a second dose should be the following statement: ‘‘Do not use given at 12 to 16 weeks of age. Annual in pregnant cows or in calves nursing revaccination with a single dose is rec- pregnant cows.’’: Provided, That such ommended. vaccines which have been shown to be (2) Modified live virus vaccines. Vac- safe for use in pregnant cows may be cinate healthy cats of any age with one excepted from this label requirement dose except that if the animal is less by the Administrator. than 12 weeks of age, a second dose (f) Unless otherwise authorized in a should be given at 12 to 16 weeks of filed Outline of Production, labels for age. Annual revaccination with a sin- inactivated bacterial products shall gle dose is recommended. Do not vac- contain an unqualified recommenda- cinate pregnant cats. tion for a repeat dose to accomplish (j) In the case of normal serum, anti- primary immunization to be given at serum, or antiserum derivatives, the an appropriate time interval: Provided, type of preservative used shall be indi- That, repeat dose recommendations cated on all labels. prescribed in paragraphs (f)(1) through (k) Unless acceptable data has been (3) of this section are required for prod- filed with Animal and Plant Health In- ucts containing the fractions listed. spection Service, to show that develop- (1) Clostridium haemolyticum. ‘‘Repeat ment of corneal opacity is not associ- the dose every 5 or 6 months in animals ated with the product, carton labels subject to reexposure.’’ and enclosures used with biological (2) Erysipelothrix rhusiopathiae. products containing modified live ca- ‘‘Swine: For breeding animals, repeat nine hepatitis virus or modified live ca- after 21 days and annually. Turkeys: nine adenovirus Type 2 shall bear the Repeat dose every 3 months.’’ following statement: ‘‘Occasionally, (3) Clostridium botulinum Type C. ‘‘Re- transient corneal opacity may occur vaccinate breeders 1 month before following the administration of this breeding.’’ product.’’ (g) In the case of a liquid product au- (l) All labels for autogenous biologics thorized in a filed Outline of Produc- shall bear the following statement: tion to be used as a diluent in a com- ‘‘Potency and efficacy of autogenous bination package, the carton labels and biologics have not been established. enclosures used for serials which are ei- This product is prepared for use only ther not tested for bactericidal or viri- by or under the direction of a veterinarian or approved specialist.’’ cidal activity or have been found un- (m) In the case of biological products satisfactory by such test shall contain containing Marek’s disease virus, all the statement: ‘‘CAUTION: DO NOT labels shall specify the Marek’s disease USE AS DILUENT FOR LIVE VAC- virus serotype(s) used in the product. CINES.’’ (h) In the case of wart vaccine, rec- (Approved by the Office of Management and ommendations shall be limited to use Budget under control number 0579–0013) in cattle. Indications for use shall be [38 FR 12094, May 9, 1973] for prophylactic use only, as an aid in EDITORIAL NOTE: For FEDERAL REGISTER ci- the control of viral papillomas (warts). tations affecting § 112.7, see the List of CFR All labels shall include a dosage rec- Sections Affected, which appears in the ommendation of at least 10 ml to be Finding Aids section of the printed volume given subcutaneously and the dose re- and at www.fdsys.gov. peated in 3 to 5 weeks. (i) Unless otherwise authorized in an § 112.8 For export only. Outline of Production filed subsequent The applicable regulations for pack- to the effective date of these amend- aging and labeling a biological product ments, all but very small final con- produced in the United States shall tainer labels for Feline Panleukopenia apply to such biological product if ex- Vaccines shall contain the following ported from the United States except recommendations for use: as otherwise provided in this section. (1) Killed virus vaccines. Vaccinate Only labels approved as provided in healthy cats of any age with one dose § 112.5 shall be used.

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(a) Biological products which have § 112.9 Biological products imported been packaged and labeled for export for research and evaluation. or which have been exported, shall be A biological product imported for re- subject to the applicable provisions in search and evaluation under a permit this paragraph. issued in accordance with § 104.4, with (1) After leaving the licensed estab- the exception of products imported lishment, a biological product shall not under § 104.4(d), shall be labeled as probe bottled, repackaged, relabeled, or vided in this section. otherwise altered in any way while in (a) The label shall identify the prod- the United States; and uct and the name and address of the (2) An exported biological product manufacturer and shall provide in- shall not be returned to the United structions for proper use of the prod- States: Provided, That, in the case of a uct, including all warnings and cau- biological product exported in labeled tions needed by the permittee to safely final containers, the Administrator use the product. may authorize by permit the importa- (b) Labels on each product to be fur- tion of a limited number for research ther distributed in accordance with and evaluation by the producing li- § 103.3 shall bear the statement ‘‘No- censee; and tice! For Experimental Use Only—Not (3) An exported biological product for Sale!’’ which is bottled, rebottled, or altered (c) The labeling shall contain any in any way in a foreign country shall other information deemed necessary by not bear a label which indicates by es- the Administrator and specified on the tablishment license number that it has permit. been prepared in the United States. [50 FR 46417, Nov. 8, 1985, as amended at 56 (b) Desiccated and frozen liquid prod- FR 66784, Dec. 26, 1991] ucts, packaged and labeled as for domestic use, may be exported without § 112.10 Special packaging and labeling. the diluent required for rehydration or dilution, as the case may be, if the la- A biological product, which requires beling includes adequate instructions special packaging and/or labeling not for preparing the product for use and provided for in this part, shall be pack- the words ‘‘For Export Only’’. aged and/or labeled in accordance with (c) Final containers of products, la- requirements written into the approved beled or unlabeled, may be exported in outline for such product. sealed shipping boxes, adequately identified as to contents with an approved PART 113—STANDARD label, and plainly marked ‘‘For Export REQUIREMENTS Only’’: Provided, That such products shall not be diverted to domestic use. APPLICABILITY (d) Completed inactivated liquid Sec. products, antiserums, and antitoxins, 113.1 Compliance. may be exported in large multiple-dose 113.2 Testing aids. containers identified with an approved 113.3 Sampling of biological products. label that contains the words ‘‘For Ex- 113.4 Exemptions to tests. port Only’’ prominently displayed. 113.5 General testing. 113.6 Animal and Plant Health Inspection (e) Concentrated inactivated liquid Service testing. product, completed except for dilution 113.7 Multiple fractions. to the proper strength for use, may be 113.8 In vitro tests for serial release. exported in large multiple-dose con- 113.9 New potency test. tainers identified with an approved 113.10 Testing of bulk material for export or label that contains the words ‘‘For Ex- for further manufacture. port Only’’ prominently displayed. STANDARD PROCEDURES [38 FR 12094, May 9, 1973, as amended at 39 113.25 Culture media for detection of bac- FR 19202, May 31, 1974; 40 FR 46093, Oct. 6, teria and fungi. 1975; 43 FR 11145, Mar. 17, 1978; 56 FR 66784, 113.26 Detection of viable bacteria and fungi Dec. 26, 1991] except in live vaccine.

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113.27 Detection of extraneous viable bac- 113.102 Leptospira Icterohaemorrhagiae teria and fungi in live vaccines. Bacterin. 113.28 Detection of mycoplasma contamina- 113.103 Leptospira Canicola Bacterin. tion. 113.104 Leptospira Grippotyphosa Bacterin. 113.29 Determination of moisture content in 113.105 Leptospira Hardjo Bacterin. desiccated biological products. 113.106 Clostridium Chauvoei Bacterin. 113.30 Detection of Salmonella contamina- 113.107 Clostridium Haemolyticum tion. Bacterin. 113.31 Detection of avian lymphoid leukosis. 113.108 Clostridium Novyi Bacterin-Toxoid. 113.32 Detection of Brucella contamination. 113.109 Clostridium Sordellii Bacterin-Tox- 113.33 Mouse safety tests. oid. 113.34 Detection of hemagglutinating vi- 113.110 Clostridium Botulinum Type C ruses. Bacterin-Toxoid. 113.35 Detection of viricidal activity. 113.111 Clostridium Perfringens Type C Tox- 113.36 Detection of pathogens by the chick- oid and Bacterin-Toxoid. en inoculation test. 113.112 Clostridium Perfringens Type D Tox- 113.37 Detection of pathogens by the chick- oid and Bacterin-Toxoid. en embryo inoculation test. 113.113 Autogenous biologics. 113.38 Guinea pig safety test. 113.114 Tetanus Toxoid. 113.39 Cat safety tests. 113.115 Staphylococcus Aureus Bacterin- 113.40 Dog safety tests. Toxoid. 113.41 Calf safety test. 113.116 Pasteurella Multocida Bacterin, 113.42 Detection of lymphocytic chorio- Avian Isolate, Type 4. meningitis contamination. 113.117 Pasteurella Multocida Bacterin, 113.43 Detection of chlamydial agents. Avian Isolate, Type 1. 113.44 Swine safety test. 113.118 Pasteurella Multocida Bacterin, 113.45 Sheep safety test. Avian Isolate, Type 3. 113.46 Detection of cytopathogenic and/or 113.119 Erysipelothrix Rhusiopathiae hemadsorbing agents. Bacterin. 113.47 Detection of extraneous viruses by 113.120 Salmonella Typhimurium Bacterin. the fluorescent antibody technique. 113.121 Pasteurella Multocida Bacterin. INGREDIENT REQUIREMENTS 113.122 Salmonella Choleraesuis Bacterin. 113.123 Salmonella Dublin Bacterin. 113.50 Ingredients of biological products. 113.51 Requirements for primary cells used KILLED VIRUS VACCINES for production of biologics. 113.200 General requirements for killed 113.52 Requirements for cell lines used for virus vaccines. production of biologics. 113.201 Canine Distemper Vaccine, Killed 113.53 Requirements for ingredients of ani- Virus. mal origin used for production of bio- 113.202 Canine Hepatitis and Canine logics. Adenovirus Type 2 Vaccine, Killed Virus. 113.54 Sterile diluent. 113.203 Feline Panleukopenia Vaccine, 113.55 Detection of extraneous agents in Killed Virus. Master Seed Virus. 113.204 Mink Enteritis Vaccine, Killed LIVE BACTERIAL VACCINES Virus. 113.205 Newcastle Disease Vaccine, Killed 113.64 General requirements for live bac- Virus. terial vaccines. 113.206 Wart Vaccine, Killed Virus. 113.65 Brucella Abortus Vaccine. 113.207 Encephalomyelitis Vaccine, Eastern, 113.66 Anthrax Spore Vaccine—Nonencap- Western, and Venezuelan, Killed Virus. sulated. 113.208 Avian Encephalomyelitis Vaccine, 113.67 Erysipelothrix Rhusiopathiae Vac- Killed Virus. cine. 113.209 Rabies Vaccine, Killed Virus. 113.68 Pasteurella Haemolytica Vaccine, 113.210 Feline Calicivirus Vaccine, Killed Bovine. Virus. 113.69 Pasteurella Multocida Vaccine, Bo- 113.211 Feline Rhinotracheitis Vaccine, vine. Killed Virus. 113.70 Pasteurella Multocida Vaccine, Avian 113.212 Bursal Disease Vaccine, Killed Isolate. Virus. 113.71 Chlamydia Psittaci Vaccine (Feline 113.213 Pseudorabies Vaccine, Killed Virus. Pneumonitis), Live Chlamydia. 113.214 Parvovirus Vaccine, Killed Virus (Canine). INACTIVATED BACTERIAL PRODUCTS 113.215 Bovine Virus Diarrhea Vaccine, 113.100 General requirements for inac- Killed Virus. tivated bacterial products. 113.216 Bovine Rhinotracheitis Vaccine, 113.101 Leptospira Pomona Bacterin. Killed Virus.

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LIVE VIRUS VACCINES ological product manufactured in a li- 113.300 General requirements for live virus censed establishment and to each serial vaccines. or subserial of a biological product in 113.301 Ovine Ecthyma Vaccine. each shipment imported for distribu- 113.302 Distemper Vaccine—Mink. tion and sale. 113.303 Bluetongue Vaccine. 113.304 Feline Panleukopenia Vaccine. § 113.2 Testing aids. 113.305 Canine Hepatitis and Canine Adenovirus Type 2 Vaccine. To better ensure consistent and re- 113.306 Canine Distemper Vaccine. producible test results when Standard 113.308 Encephalomyelitis Vaccine, Ven- Requirement tests prescribed in the ezuelan. regulations are conducted, National 113.309 Bovine Parainfluenza3 Vaccine. Veterinary Services Laboratories, U.S. 113.310 Bovine Rhinotracheitis Vaccine. Department of Agriculture, may pro- 113.311 Bovine Virus Diarrhea Vaccine. 113.312 Rabies Vaccine, Live Virus. vide testing aids, when available, to li- 113.313 Measles Vaccine. censees, permittees, and applicants for 113.314 Feline Calicivirus Vaccine. licenses and permits. Such aids shall be 113.315 Feline Rhinotracheitis Vaccine. as follows: 113.316 Canine Parainfluenza Vaccine. (a) Supplemental Assay Method 113.317 Parvovirus Vaccine (Canine). (SAM) is a technical bulletin con- 113.318 Pseudorabies Vaccine. 113.319–113.324 [Reserved] taining detailed instructions for con- 113.325 Avian Encephalomyelitis Vaccine. ducting a test. Such instructions shall 113.326 Avian Pox Vaccine. be in accordance with the procedures 113.327 Bronchitis Vaccine. currently being followed at National 113.328 Fowl Laryngotracheitis Vaccine. Veterinary Services Laboratories and 113.329 Newcastle Disease Vaccine. as improved, proven procedures are de- 113.330 Marek’s Disease Vaccines. veloped, shall be revised and reissued 113.331 Bursal Disease Vaccine. prior to application. 113.332 Tenosynovitis Vaccine. (b) Standard Reference Preparation DIAGNOSTICS AND REAGENTS is a serum, virus, bacterial culture, or 113.400–113.405 [Reserved] antigen to be used in test systems for 113.406 Tuberculin, Intradermic. direct comparison with serials of bio- 113.407 Pullorum antigen. logical products under test. 113.408 Avian mycoplasma antigen. (c) Standard Test Reagent is a serum, 113.409 Tuberculin—PPD Bovis, antitoxin, fluorescent antibody con- Intradermic. jugate, toxin, virus, bacterial cultural, ANTIBODY PRODUCTS or antigen to be used in test systems but not for direct comparison with se- 113.450 General requirements for antibody rials of biological products under test. products. 113.451 Tetanus Antitoxin. (d) Seed cultures are small quantities 113.452 Erysipelothrix Rhusiopathiae Anti- of standard organisms to be propagated body. by the recipient to establish a supply 113.453 [Reserved] for use. 113.454 Clostridium Perfringens Type C (e) Test Code Number is a number as- Antitoxin. signed by Animal and Plant Health In- 113.455 Clostridium Perfringens Type D spection Service to each test procedure Antitoxin. 113.456–113.498 [Reserved] specified in the Standard Requirements 113.499 Products for treatment of failure of and in each filed Outline of Production passive transfer. where such test is conducted to support a request for release of a serial or sub- AUTHORITY: 21 U.S.C. 151–159; 7 CFR 2.22, 2.80, and 371.4. serial.

SOURCE: 34 FR 18004, Nov. 7, 1969, unless [39 FR 21041, June 18, 1974, as amended at 40 otherwise noted. FR 758, Jan. 3, 1975; 50 FR 21799, May 29, 1985; 56 FR 66784, Dec. 26, 1991] APPLICABILITY § 113.3 Sampling of biological prod- § 113.1 Compliance. ucts. The regulations in this part apply to Each licensee and permittee shall each serial or subserial of a licensed bi- furnish representative samples of each

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serial or subserial of a biological prod- section, the number of such samples uct manufactured in the United States from each serial and the minimum or imported into the United States as quantity of product to be provided in prescribed in this section. Additional each sample shall be stated in the filed samples may be purchased in the open Outline of Production. market by a Animal and Plant Health (b) Unless otherwise prescribed by Inspection Service representative. the Administrator, the number of final (a) Either an employee of the Depart- container samples to be selected from ment of Agriculture, of the licensee, or each serial and subserial shall be: of the permittee, as designated by the (1) Vaccines: Administrator shall select prerelease (i) Six multiple-dose samples of samples of biological product in the Brucella Abortus Vaccine; number prescribed in paragraph (b) of (ii) Twelve samples of all other live this section. Each sample shall be bacterial vaccines; marked for identification by the person (iii) Two samples of Coccidiosis Vac- making the selection after which they cine; shall be packaged by the licensee or (iv) Eighteen samples of Rabies Vac- permittee, as the case may be, and for- cine, Modified Live Virus; warded to National Veterinary Serv- (v) Sixteen samples of all other vac- ices Laboratories; except that an em- cines consisting of live microorga- ployee of the Department may forward nisms; or deliver the samples to National Vet- (vi) Thirty single-dose or 14 multiple- erinary Services Laboratories if such dose samples of Equine action deemed advisable by the Admin- Encephalomyelitis Vaccine, Killed istrator. Virus; (1) Selection shall be made as fol- (vii) Twenty-two single-dose or 14 lows: multiple-dose samples of Rabies Vac- (i) Nonviable liquid biological prod- cine, Killed Virus; ucts—either bulk or final container (viii) Sixteen single-dose or 12 mul- samples of completed product shall be tiple-dose samples of all other vaccines selected for purity, safety, or potency consisting of killed microorganisms. tests. Biological product in final con- (2) tainer shall be selected to test for via- Bacterins and bacterin-toxoids: ble bacteria and fungi. (i) Twelve samples of single-fraction (ii) Viable liquid biological products; products; samples shall be in final containers and (ii) Thirteen samples of two-fraction shall be randomly selected at the end products; of the filling operation. Bulk con- (iii) Fourteen samples of products tainers of completed product may be consisting of 3 or more fractions. sampled when authorized by the Ad- (3) Antiserums: Twelve samples of ministrator. antiserum recommended for large ani- (iii) Desiccated biological products; mals or 14 samples of antiserum rec- samples shall be in final containers and ommended for small animals or the shall be randomly selected if des- number of reagent serum samples pre- iccated in the final container. Biologi- scribed in the filed Outline of Produc- cal products desiccated in bulk shall be tion for the product. sampled at the end of the filling oper- (4) Antitoxins: ation. (i) Fourteen single-dose or 12 mul- (iv) Representative samples of each tiple dose samples of Tetanus Anti- serial or subserial in each shipment of toxin; imported biological products shall be (ii) Twelve samples of all other selected. antitoxins. (2) Comparable samples shall be used (5) Toxoids: by Animal and Plant Health Inspection (i) Eighteen single-dose or 12 mul- Service, the licensee, and the per- tiple dose samples of all toxoids. mittee for similar tests. (6) Antigens: Twelve samples of poul- (3) When bulk samples of completed try antigens or 20 samples of tuber- product in liquid form are to be tested culin or four samples of all other diag- as prescribed in paragraph (a)(1) of this nostic antigens.

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(7) Diagnostic test kits: Two samples of a licensed product shall be submitted diagnostic test kits. The licensee or only upon request from the animal and permittee will hold one of these se- Plant Health Inspection Service. Ex- lected samples at the storage tempera- cept for miscellaneous products speci- ture recommended on the label while fied in paragraph (b)(9) of this section, awaiting a request by the animal and the number of such samples shall be at Plant Health Inspection Service to sub- least one and one-half times the num- mit the additional sample. If submis- ber prescribed for such product in para- sion is not requested by the Animal graph (b) of this section. Samples of and Plant Health Inspection Service, Master Seeds and Master Cell Stocks the additional sample may be returned with a minimum individual volume of 1 to the serial inventory after the serial ml shall be submitted as follows: is released. In the case of diagnostic test kits in which final packaging con- (1) Ten samples of Bacterial Master sists of multiple microtiter test plates Seeds. or strips, the licensee or permittee may (2) Thirteen samples of viral Master submit a specified number of test Seeds or nonviral Master Seeds requir- plates or strips along with all other ing cell culture propagation. For Mas- test reagents as prescribed in a filed ter Seeds isolated or passed in a cell Outline of Production and retain a line different from the species of in- similar amount as a second sample for tended use, an additional 2 samples are submission upon request. When the ini- required for each additional species. tial sample is not representative of For Master Seeds grown in cell culture final packaging by the licensee of per- and intended for use in more than one mittee, e.g., does not consist of all the species, an additional 2 samples are re- microtiter test plates or strips, the sec- quired for each additional species. ond sample is not eligible to be re- (3) Thirty-six samples of at least 1 ml turned to serial inventory after the se- each or six samples of at least 1 ml rial is released. each, one sample of at least 20 ml, and (8) Autogenous biologics: With the ex- one sample of at least 10 ml of Master ception of the first serial or subserial, Cell Stocks. In the case of Master Cell 10 samples must be selected and sub- Stocks which are persistently infected mitted to the Animal and Plant Health with a virus, an additional four sam- Inspection Service from each serial or ples of at least 1 ml each are required. subserial of an autogenous biologic eligible to be shipped that consists of If these persistently infected cell more than 50 containers. For first seri- stocks are intended for use in more als or subserials eligible for shipment than one species, an additional two consisting of more than 50 containers, samples of at least 1 ml each are re- 10 samples from each serial or subserial quired for each additional species. must be selected and held for submis- (4) Four samples of the Master Cell sion to the Animal and Plant Health Stock + n (highest passage) cells. Inspection Service upon request in ac- (d) Sterile diluent: A sample of Ster- cordance with paragraph (e)(4) of this ile Diluent shall accompany each sam- section. For serials or subserials of au- ple of product, other than Marek’s Dis- togenous biologic with 50 or fewer con- ease Vaccine, if such diluent is re- tainers, no samples, other than those quired to rehydrate or dilute the prod- required by paragraph (e) of this sec- uct before use. The volume of diluent tion, are required. shall be an appropriate amount to re- (9) Miscellaneous: The number of sam- hydrate or dilute the product. Samples ples from products not in the cat- of Sterile Diluent prepared for use with egories provided for in paragraphs Marek’s Disease Vaccine shall be sub- (b)(1) through (b)(8) of this section mitted upon request from the Animal shall be prescribed in the filed Outline and Plant Health Inspection Service. of Production for the product. (c) Prelicensing and Outline of Pro- (e) Reserve samples shall be selected duction changes: Samples needed to from each serial and subserial of bio- support a license application or a logical product. Such samples shall be change in the Outline of Production for

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selected at random from final con- tion or Standard Requirements for the tainers of completed product by an em- product to establish the product to be ployee of the Department, of the li- pure, safe, potent, and efficacious. censee, or of the permittee, as des- (b) Tests of biological products shall ignated by the administrator. Each be observed by a competent employee sample shall: of the manufacturer during all critical (1) Consist of 5 single-dose packages, periods. A critical period shall be the 2 multiple-dose packages, or 2 diag- time when certain specified reactions nostic test kits, except that, in the must occur in required tests to prop- case of diagnostic test kits in which erly evaluate the results. final packaging consists of multiple (c) Records of all tests shall be kept microtiter test plates or strips, a sam- in accordance with part 116 of this ple may consist of a specified number chapter. Results of all required tests of test plates or strips along with all prescribed in the filed Outline of Pro- other test reagents as prescribed in a duction or the Standard Requirements filed Outline of Production; for the product shall be submitted to (2) Be adequate in quantity for appro- Animal and Plant Health Inspection priate examination and testing; Service. Blank forms shall be furnished (3) Be truly representative and in upon request to Animal and Plant final containers; Health Inspection Service. (4) Be held in a special compartment (d) When the initial or any subse- set aside by the licensee or permittee quent test is declared a ‘‘No test,’’ the for holding these samples under refrig- reasons shall be reported in the test eration at the storage temperature rec- records, the results shall not be consid- ommended on the labels for 6 months ered as final, and the test may be re- after the expiration date stated on the peated. labels. The samples that are stored in (e) When new test methods are devel- this manner shall be delivered to the oped and approved by Animal and Animal and Plant Health Inspection Plant Health Inspection Service, bio- Service upon request. logical products tested thereafter shall (Approved by the Office of Management and be evaluated by such methods, and if Budget under control number 0579–0013) not found to be satisfactory when so [38 FR 29886, Oct. 30, 1973, as amended at 40 tested shall not be released. FR 758, Jan. 3, 1975; 40 FR 49768, Oct. 24, 1975; (Approved by the Office of Management and 41 FR 56627, Dec. 29, 1976; 48 FR 9506, Mar. 7, Budget under control number 0579–0059) 1983; 48 FR 57473, Dec. 30, 1983; 50 FR 21799, May 29, 1985; 56 FR 66784, Dec. 26, 1991; 60 FR [34 FR 18004, Nov. 4, 1969, as amended at 39 14356, Mar. 17, 1995; 67 FR 15713, Apr. 3, 2002] FR 25463, July 11, 1974; 40 FR 45420, Oct. 2, 1975; 40 FR 46093, Oct. 6, 1975; 41 FR 6751, Feb. § 113.4 Exemptions to tests. 13, 1976; 48 FR 57473, Dec. 30, 1983; 56 FR 66784, Dec. 26, 1991] (a) The test methods and procedures contained in all applicable Standard § 113.6 Animal and Plant Health In- Requirements shall be complied with spection Service testing. unless otherwise exempted by the Ad- A biological product shall with rea- ministrator and provided that such ex- sonable certainty yield the results in- emption is noted in the filed Outline of tended when used as recommended or Production for the product. suggested in its labeling or proposed la- (b) Test methods and procedures by beling prior to the expiration date. which the biological products shall be (a) The Administrator is authorized evaluated shall be designated in the to cause a biological product, manufac- Outline of Production for such prod- tured in the United States or imported ucts. into the United States, to be examined [38 FR 29887, Oct. 30, 1973, as amended at 56 and tested for purity, safety, potency, FR 66784, Dec. 26, 1991] or efficacy; in which case, the licensee or permittee shall withhold such prod- § 113.5 General testing. uct from the market until a determina- (a) No biological product shall be re- tion has been made. leased prior to the completion of tests (b) The final results of each test con- prescribed in a filed Outline of Produc- ducted by the licensee and Animal and

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Plant Health Inspection Service shall release when an evaluation can, with be considered in evaluating a biological reasonable certainty, be made by: product. A serial or subserial which has (1) Subjecting the master seed to the been found unsatisfactory by a re- applicable requirements prescribed in quired test prescribed in a filed Outline §§ 113.64, 113.100, 113.200, and 113.300; of Production or Standard Require- (2) Testing the Master Seed for ment is not in compliance with the reg- immunogenicity in a manner accept- ulations and shall not be released for able to the Animal and Plant Health market. Inspection Service (APHIS); [34 FR 18004, Nov. 7, 1969, as amended at 40 (3) Establishing satisfactory potency FR 45420, Oct. 2, 1975; 40 FR 53378, Nov. 18, for the product in accordance with the 1975; 41 FR 6751, Feb. 13, 1976; 56 FR 66784, following provisions: Dec. 26, 1991] (i) Potency for live products may be determined by log10 virus titer or de- § 113.7 Multiple fractions. termining the live bacterial count (a) When a biological product con- based on the protective dose used in tains more than one immunogenic frac- the Master Seed immunogenicity test tion, the completed product shall be plus an adequate overage for adverse evaluated by tests applicable to each conditions and test error; and fraction. (ii) Potency for inactivated products (b) When similar potency tests are re- may be determined using tests for rel- quired for more than one fraction of a ative antigen content by comparing combination biological product, dif- the antigen content of the test serial ferent animals must be used to evalu- to a reference preparation using a par- ate each fraction except when written allel line immunoassay or equivalent Standard Requirements or outlines of method which measures linearity, production make provisions and set specificity, and reproducibility in a forth conditions for use of the same manner acceptable to APHIS. animals for testing different fractions. (b) In the case of live products, each (c) When the same safety test is re- serial and subserial of desiccated prod- quired for more than one fraction, re- uct derived from an approved Master quirements are fulfilled by satisfactory Seed and bulk or final container sam- results from one test of the completed ples of each serial of completed liquid product. product derived from an approved Mas- (d) When an inactivated fraction(s) is ter Seed shall be evaluated by a test used as a diluent for a live virus frac- procedure acceptable to APHIS. On the tion(s), the inactivated fraction(s) may basis of the results of the test, as com- be tested separately and the live virus pared with the required minimum po- fraction(s) may be tested separately: tency, each serial and subserial shall Provided, That, the viricidal test re- either be released to the firm for mar- quirements prescribed in § 113.100 are keting or withheld from the market. complied with. The evaluation of such products shall (e) Virus titrations for a multivirus be made in accordance with the fol- product shall be conducted by methods lowing criteria: which will quantitate each virus. (1) If the initial test shows the count [34 FR 18004, Nov. 7, 1969, as amended at 40 or titer to equal or exceed the required FR 46093, Oct. 6, 1975; 56 FR 66785, Dec. 26, minimum, the serial or subserial is sat- 1991] isfactory without additional testing. (2) If the initial test shows the count § 113.8 In vitro tests for serial release. or titer to be lower than the required (a) Master Seed which has been es- minimum, the serial or subserial may tablished as pure, safe, and be retested, using double the number of immunogenic shall be used for pre- samples. The average counts or titers paring seed for production as specified obtained in the retests shall be deter- in the Standard Requirements or in the mined. If the average is less than the filed Outline of Production. The Ad- required minimum, the serial or sub- ministrator may exempt a product serial is unsatisfactory without further from a required animal potency test for consideration.

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(3) If the average is equal to or great- ceptable to APHIS. 1 Firms currently er than the required minimum, the fol- using immunoassays which do not sat- lowing shall apply to live virus vac- isfy this requirement shall have 2 years cines: from the effective date of the final rule (i) If the difference between the aver- to update their filed Outlines of Pro- age titer obtained in the retests and duction to be in compliance with this the titer obtained in the initial test is requirement unless granted an exten- 100.7 or greater, the initial titer may be sion by the Administrator based on a considered a result of test system error showing by the firm seeking the exten- and the serial or subserial considered sion that they have made a good faith satisfactory for virus titer. effort with due diligence to achieve (ii) If the difference between the av- compliance. On the basis of the results erage titer obtained in the retests and of such test procedures, each serial the titer obtained in the initial test is that meets the required minimum po- less than 100.7, a new average shall be tency shall be released to the firm for determined using the titers obtained in marketing; each serial not meeting the all tests. If the new average is below required minimum potency shall be the required minimum, the serial or withheld from the market. The evalua- subserial is unsatisfactory. tion of such products shall be made in accordance with the following criteria: (4) If the average is equal to or great- (1) A test that results in no valid er than the required minimum, the fol- lines is considered a ‘‘no test’’ and may lowing shall apply to bacterial vac- be repeated. cines: (2) An initial test (test 1) that results (i) If the average count obtained in in valid lines that are not parallel is the retests is at least three times the considered a valid equivocal test. Re- count obtained in the initial test, the lease of the serial may not be based on initial count may be considered a re- such test since the result cannot be sult of test system error and the serial termed ‘‘satisfactory’’ or ‘‘unsatisfac- or subserial considered satisfactory for tory.’’ bacterial count. (3) If the initial test (test 1) shows (ii) If the average count obtained in that potency equals or exceeds the re- the retests is less than three times the quired minimum potency, the serial is count obtained in the initial test, a satisfactory without additional test- new average shall be determined using ing. the counts obtained in all tests. If the (4) If the initial test (test 1) is an new average count is below the re- equivocal test due to lack of par- quired minimum, the serial or sub- allelism, the serial may be retested up serial is unsatisfactory. to three times (tests 2, 3, and 4) with (5) Exceptions. When a product is eval- disposition to be as specified in para- uated in terms other than log10 virus graphs (c)(4)(i) and (ii) of this section; titer or organism count, an appropriate Provided, That, if the serial is not re- difference between the average potency tested or the other provisions of this value obtained in the retests and the section are not satisfied, the serial potency value obtained in the initial shall be deemed unsatisfactory. test shall be established for use in (i) If: The first retest (test 2) fol- paragraphs (b)(3) and (b)(4) of this sec- lowing an initial equivocal test; the tion to evaluate such products and second retest (test 3) following two shall be specified in the product Stand- consecutive equivocal tests (tests 1 and ard Requirement or filed Outline of Production. 1 A method for evaluating relative antigen (c) In the case of inactivated prod- content, Supplemental Assay Method 318, ucts, bulk or final container samples of and relative potency calculation software completed product from each serial de- are available from the United States Depart- rived from an approved Master Seed, ment of Agriculture, Animal and Plant shall be evaluated for relative antigen Health Inspection Service, Veterinary Serv- content (potency) as compared with an ices, National Veterinary Services Labora- tories, Center for Veterinary Biologics—Lab- unexpired reference by a parallel line oratory, 1800 Dayton Road, P. O. Box 844, immunoassay or other procedure ac- Ames, Iowa 50010.

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2); or the third retest (test 4) following serial equals or exceeds the required three consecutive equivocal tests (tests minimum potency, the serial is deemed 1, 2, and 3) shows that the potency satisfactory. If both retests (tests 2 and equals or exceeds the required min- 3) or if the third retest (test 4) is an imum potency, the serial is satisfac- equivocal test, the accumulated test tory. results shall be considered indicative of (ii) If the first retest (test 2) fol- a lack of potency and release of the se- lowing an initial equivocal test shows rial withheld, in which case the li- that potency is less than the required censee may submit data confirming the minimum potency, disposition of the continued validity of the test system serial will be based on the outcome of to APHIS for review and approval. If retests 2 and 3 (tests 3 and 4) as follows: the data are acceptable to APHIS, the if either retest (test 3 or 4) shows that potency test may be repeated by the potency is less than the required min- firm, subject to the provisions specified imum potency, the serial is unsatisfac- in paragraphs (c)(4) (i) and (ii) and tory. If either retest 2 or retest 3 (tests (c)(5) (i) and (ii) of this section, and 3 or 4) is an equivocal test, or in the confirmatory testing by APHIS. event that each retest (tests 2, 3, and 4) (d) Extending the dating of a reference. following an initial equivocal test is All determinations of relative antigen also an equivocal test, the accumulated content using parallel line test results shall be considered indic- immunoassays or equivalent methods ative of a lack of potency and release shall be conducted with an unexpired of the serial withheld. In which case, reference. The lot of reference used to the licensee may submit data confirming the continued validity of the determine antigenic content shall have test system to APHIS for review and an initial dating period equal to the approval. If the data are acceptable to dating of the product or as supported APHIS, the potency test may be re- by data acceptable to APHIS, except peated by the firm, subject to the pro- that frozen references may have an ini- visions specified in paragraphs (i) and tial dating of up to 5 years, Provided, (ii) and confirmatory testing by That the request for dating of the fro- APHIS. zen references beyond the dating of the (5) If the initial test (test 1) shows product is supported by preliminary that potency is less than the required data acceptable to APHIS and includes minimum potency, the serial may be provisions for monitoring the stability retested a minimum of two times (tests of the reference to determine when the 2 and 3) but not more than three times potency starts to decline and for tak- (tests 2, 3, and 4) with disposition as ing the appropriate steps to requalify a specified in paragraphs (c)(5) (i) and (ii) reference with declining potency either of this section; Provided, That, if the by testing a Qualifying Serial in host serial is not retested or the other pro- animals or by providing other evidence visions of this section are not satisfied, of immunogenicity, e.g., antibody the serial shall be deemed unsatisfac- titers or laboratory animal test data tory. previously correlated to host animal (i) If two consecutive retests (tests 2 protection in a manner acceptable to and 3) show that potency of the serial APHIS. Prior to the expiration date, equals or exceeds the required min- such reference may be granted an ex- imum potency, the serial is satisfac- tension of dating, Provided, That its tory. If one of the two retests (test 2 or immunogenicity has been confirmed 3) shows that the potency is less than using a Qualifying Serial of product in the required minimum potency, the se- a manner acceptable to APHIS. The rial is unsatisfactory. dating period of the Master Reference (ii) If one of the retests (tests 2 or 3) and Working Reference may be ex- shows that the potency equals or extended by data acceptable to APHIS if ceeds the required minimum potency the minimum potency of the Master and the other retest (test 2 or 3) is an Reference is determined to be ade- equivocal test, a third retest (test 4) quately above the minimum level need- may be performed. If the third retest ed to provide protection in the host (test 4) shows that the potency of the animal. If a new Master Reference is

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established, it shall be allowed an ini- subjected to similar animal potency tial dating period equal to the dating tests by Animal and Plant Health In- of the product or as supported by data spection Service or the licensee or acceptable to APHIS, except that fro- both. zen references may have an initial dat- (ii) If another serial is found unsatis- ing period of 5 years, or as supported factory for potency, the product shall by data acceptable to APHIS. Prior to be removed from the market while a the expiration date, such reference reevaluation of the product is made may be granted an extension of dating and the problem is resolved. by confirming its immunogenicity using a Qualifying Serial of product. [49 FR 22625, May 31, 1984, as amended at 56 (e) Final container samples of com- FR 66784, 66786, Dec. 26, 1991; 62 FR 19038, Apr. pleted product derived from Master 18, 1997; 72 FR 72564, Dec. 21, 2007] Seed found immunogenic in accordance § 113.9 New potency test. with paragraph (a) of this section and found satisfactory in accordance with A potency test written into the filed paragraphs (b) and (c) of this section Outline of Production for a product may also be subjected to an animal po- shall be considered confidential infor- tency test by Animal and Plant Health mation by Animal and Plant Health In- Inspection Service as provided in this spection Service until at least two ad- paragraph. Products shall be used ac- ditional product licenses are issued for cording to label directions including the product or unless use of the test is dose(s) and route of administration. authorized by the licensee, in which (1) A one stage test using 20 vac- case, such potency test may be pub- cinates and 5 controls or a two stage lished as part of the Standard Require- test using 10 vaccinates and 5 controls ment for the product. for each stage shall be used. The cri- (a) Until a potency test is published teria used for judging the specific reas part of the Standard Requirement sponse in the controls and vaccinates for the product, reference to such a shall be in accordance with the test test shall be made in the filed Outline protocol used in the Master Seed of Production and the test shall be con- immunogenicity test. ducted. (2) If at least 80 percent of the con- (b) When a potency test has been pub- trols do not show specific responses to lished as part of the Standard Require- challenge, the test is inconclusive and ment, such test shall be conducted un- may be repeated. If a vaccinate shows less the product is specifically exempt- the specific responses to challenge ex- ed as provided in § 113.4. pected in the controls, the vaccinate shall be listed as a failure. [40 FR 14084, Mar. 28, 1975, as amended at 56 (3) The results of the testing shall be FR 66784, Dec. 26, 1991] evaluated according to the following table: § 113.10 Testing of bulk material for export or for further manufacture. CUMULATIVE TOTALS When a product is prepared in a licensed establishment for export in Num- Failures for Failures for large multiple-dose containers as pro- Stage ber of satisfactory unsatisfac- ani- vided in § 112.8(d) or (e) of this sub- mals serials tory serials chapter or for further manufacturing 1 ...... 10 1 or less ...... 3 or more. purposes as provided in § 114.3(d) of this 2 (or 1) ...... 20 4 or less ...... 5 or more. subchapter, samples of the bulk material shall be subjected to all required (4) When a serial has been found un- tests prescribed in the filed Outline of satisfactory for potency by the test Production or Standard Requirements provided in paragraphs (e)(1), (2), and for the product. Samples of con- (3) of this section, the serial shall be centrated liquid product shall be di- withheld from the market and the fol- luted to a volume equal to the contents lowing actions taken: of the sample times the concentration (i) The Administrator shall require factor prior to initiating potency tests. that at least two additional serials prepared with the same Master Seed be [49 FR 45846, Nov. 21, 1984]

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STANDARD PROCEDURES may be considered in determining the proper ratio. § 113.25 Culture media for detection of bacteria and fungi. [35 FR 16039, Oct. 13, 1970, as amended at 37 FR 2430, Feb. 1, 1972; 41 FR 27715, July 6, 1976; (a) Ingredients for which standards 56 FR 66784, Dec. 26, 1991] are prescribed in the United States Pharmacopeia, or elsewhere in this § 113.26 Detection of viable bacteria part, shall conform to such standards. and fungi except in live vaccine. In lieu of preparing the media from the Each serial and subserial of biologi- individual ingredients, they may be cal product except live vaccines shall made from dehydrated mixtures which, be tested as prescribed in this section when rehydrated with purified water, unless otherwise specified by the Ad- have the same or equivalent composi- ministrator. When cell lines, primary tion as such media and have growth- cells, or ingredients of animal origin promoting buffering, and oxygen ten- used in the preparation of a biological sion-controlling properties equal to or product are required to be free of via- better than such media. The formulas ble bacteria and fungi, they shall also for the composition of the culture be tested as prescribed in this section. media prescribed in §§ 113.26 and 113.27 (a) The media to be used shall be as are set forth in the United States Phar- follows: macopeia, 19th Edition. (1) Fluid Thioglycollate Medium with (b) The licensee shall test each quan- 0.5 percent beef extract shall be used to tity of medium prepared at one time test for bacteria in biological products from individual ingredients and the containing clostridial toxoids, first quantity prepared from each lot of bacterins, and bacterin-toxoids. commercial dehydrated medium for (2) Fluid Thioglycollate Medium with growth-promoting qualities. If any por- or without 0.5 percent beef extract tion of a lot of commercial dehydrated shall be used to test for bacteria in bio- medium is held for 90 days or longer logical products other than clostridial after being so tested, it shall be re- toxoids, bacterins, and bacterin-tox- tested before use. Two or more strains oids. of micro-organisms that are exacting (3) Soybean-Casein Digest Medium in their nutritive requirements shall be shall be used to test biological prod- used. More than one dilution shall be ucts for fungi; provided, that Fluid used to demonstrate the adequacy of Thioglycollate Medium without beef the medium to support the growth of a extract shall be substituted when test- minimum number of micro-organisms. ing biological products containing mer- (c) The sterility of the medium shall curial preservatives. be confirmed by incubating an ade- (b) Test procedure: quate number of test vessels and exam- (1) Ten test vessels shall be used for ining each for growth. Additional con- each of two media selected in accord- trol may be used by incubation of rep- ance with paragraph (a)(1), (a)(2), or resentative uninoculated test vessels (a)(3) of this section. Each test vessel for the required incubation period dur- shall contain sufficient medium to ne- ing each test. gate the bacteriostatic or fungistatic (d) A determination shall be made by activity in the inoculum as determined the licensee for each biological product in § 113.25(d). of the ratio of inoculum to medium (2) Inoculum: which shall result in sufficient dilution (i) When completed product is tested, of such product to prevent 10 final container samples from each bacteriostatic and fungistatic activity. serial and each subserial shall be test- The determination may be made by ed. One ml from each sample shall be tests on a representative biological inoculated into a corresponding indi- product for each group of comparable vidual test vessel of culture medium: products containing identical preserva- Provided, That, if each final container tives at equal or lower concentrations. sample contains less than 2 ml, one- Inhibitors or neutralizers of preserva- half of the contents shall be used as tives, approved by the Administrator, inoculum for each test vessel.

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(ii) When cell lines, primary cells, or section. A Master Seed found unsatis- ingredients of animal origin are tested, factory shall not be used in vaccine at least a 20 ml test sample from each production and a serial found unsatis- lot shall be tested. One ml shall be in- factory shall not be released. oculated into each test vessel of me- (a) Live viral vaccines. Each serial and dium. subserial of live viral vaccine shall be (3) Incubation shall be for an observa- tested for purity as prescribed in this ° ° tion period of 14 days at 30 to 35 C. to paragraph. However, products of chick- ° test for bacteria and 14 days at 20 to 25 en embryo origin recommended for ad- ° C. to test for fungi. ministration other than by parenteral (4) If the inoculum renders the me- injection may be tested as provided in dium turbid so that the absence of paragraph (e) of this section. growth cannot be determined by visual (1) Soybean Casein Digest Medium examination, subcultures shall be made on the seventh to eleventh day from bi- shall be used. ological products prepared from (2) Ten final container samples from clostridial toxoids, bacterins, and each serial and subserial shall be test- bacterin-toxoids and the third to sev- ed. enth day for other biological products. (3) Immediately prior to starting the Portions of the turbid medium in test, frozen liquid vaccine shall be amounts of not less than 1.0 ml. shall thawed, and desiccated vaccine shall be be transferred to 20 to 25 ml. of fresh rehydrated as recommended on the medium, and incubated the balance of label with accompanying diluent or the 14-day period. with sterile purified water. (c) Examine the contents of all test (4) To test for bacteria, place 0.2 ml vessels for macroscopic microbial of vaccine from each final container growth during the incubation period. into a corresponding individual vessel When demonstrated by adequate con- containing at least 120 ml of Soybean trols to be invalid, the test may be re- Casein Digest Medium. Additional me- peated. For each set of test vessels rep- dium shall be used if the determination resenting a serial or subserial in a required in § 113.25(d) indicates the need valid test, the following rules shall for a greater dilution of the product. apply: Incubation shall be at 30 °to 35 °C for 14 (1) If no growth is found in any test days. vessel, the serial or subserial meets the (5) To test for fungi, place 0.2 ml of requirements of the test. vaccine from each final container sam- (2) If growth is found in any test ves- ple into a corresponding individual vessel, one retest to rule out faulty tech- sel containing at least 40 ml of Soy- nique may be conducted using 20 un- bean Casein Digest Medium. Additional opened final container samples. medium shall be used if the determina- (3) If growth is found in any test ves- tion required in § 113.25(d) indicates the sel of the final test, the serial, sub- need for a greater dilution of the prod- serial, or ingredients to be used in the uct. Incubation shall be at 20 °to 25 °C preparation of a biological product, as the case may be, is unsatisfactory. for 14 days. (6) Examine the contents of all test [35 FR 16039, Oct. 13, 1970, as amended at 37 vessels macroscopically for microbial FR 2430, Feb. 1, 1972; 39 FR 21042, June 18, growth at the end of the incubation pe- 1974; 40 FR 758, Jan. 3, 1975; 40 FR 14084, Mar. 28, 1975; 56 FR 66784, Dec. 26, 1991] riod. If growth in a vessel cannot be reliably determined by visual examina- § 113.27 Detection of extraneous viable tion, judgment shall be confirmed by bacteria and fungi in live vaccines. subcultures, microscopic examination, Unless otherwise specified by the Ad- or both. ministrator or elsewhere exempted in (7) For each set of test vessels rep- this part, each serial and subserial of resenting a serial or subserial tested live vaccine and each lot of Master according to these procedures, the fol- Seed Virus and Master Seed Bacteria lowing rules shall apply: shall be tested for extraneous viable (i) If growth is found in 2 or 3 test bacteria and fungi as prescribed in this vessels of the initial test, 1 retest to

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rule out faulty technique may be con- subculturing, microscopic examina- ducted using 20 unopened final con- tion, or both. tainer samples. (7) For each set of test vessels rep- (ii) If no growth is found in 9 or 10 of resenting a serial or subserial tested the test vessels in the initial test, or 19 according to these procedures, the fol- or 20 vessels in the retest, the serial or lowing rules shall apply: subserial meets the requirements of (i) If extraneous growth is found in 2 the test. or 3 test vessels of the initial test, 1 (iii) If growth is found in four or retest to rule out faulty technique may more test vessels in the initial test, or be conducted using 20 unopened final two or more in a retest, the serial or container samples. subserial is unsatisfactory. (ii) If no extraneous growth is found (b) Live bacterial vaccines. Each serial in 9 or 10 test vessels in the initial test, or subserial of live bacterial vaccine or 19 or 20 vessels in the retest, the se- shall be tested for purity as prescribed rial or subserial meets the require- in this paragraph. ments of the test. (1) Soybean Casein Digest Medium (iii) If extraneous growth is found in and Fluid Thioglycollate Medium shall 4 or more test vessels in the initial be used. test, or 2 or more in a retest, the serial (2) Ten final container samples from or subserial is unsatisfactory. each serial and subserial shall be test- (c) Master Seed Virus. Not less than 4 ed. ml of each lot of Master Seed Virus (3) Immediately prior to starting the shall be tested. Frozen liquid Master test, frozen liquid vaccine shall be Seed Virus shall be thawed, and des- thawed, and desiccated vaccine shall be iccated Master Seed Virus shall be re- rehydrated as recommended on the hydrated with Soybean Casein Digest label with accompanying diluent or Medium immediately prior to starting with sterile purified water. Product the test. recommended for mass vaccination (1) To test for bacteria, place 0.2 ml shall be rehydrated at the rate of 30 ml of the sample of Master Seed Virus into sterile purified water per 1,000 doses. 10 individual vessels each containing at (4) To test for extraneous bacteria, least 120 ml of Soybean Casein Digest place 0.2 ml of vaccine from each final Medium. Incubation shall be at 30 °to container into a corresponding indi- 35 °C for 14 days. vidual vessel containing at least 40 ml (2) To test for fungi, place 0.2 ml of of Fluid Thioglycollate Medium. Addi- the sample of Master Seed Virus into 10 tional medium shall be used if the de- individual vessels each containing at termination required in § 113.25(d) indi- least 40 ml of Soybean Casein Digest cates the need for a greater dilution of ° the product. Incubation shall be at 30 Medium. Incubation shall be at 20 to ° °to 35 °C for 14 days. 25 C for 14 days. (5) To test for extraneous fungi, place (3) Examine the contents of all test 0.2 ml of vaccine from each final con- vessels macroscopically for microbial tainer into a corresponding individual growth at the end of the incubation pe- vessel containing at least 40 ml of Soy- riod. If growth in a vessel cannot be re- bean Casein Digest Medium. Additional liably determined by visual examina- medium shall be used if the determination, judgment shall be confirmed by tion required in § 113.25(d) indicates the subcultures, microscopic examination, need for a greater dilution of the prod- or both. uct. Incubation shall be at 20 °to 25 °C (4) For each set of test vessels rep- for 14 days. resenting a lot of Master Seed Virus (6) Examine the contents of all test tested according to these procedures, vessels macroscopically for atypical the following rules shall apply: microbial growth at the end of the in- (i) If growth is found in any test ves- cubation period. If growth of extra- sel of the initial test, one retest to rule neous microorganisms cannot be reli- out faulty technique may be conducted ably determined by visual examina- using a new sample of Master Seed tion, judgment shall be confirmed by Virus.

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(ii) If growth is found in any test ves- (2) Ten final containers from each se- sel of the final test, the lot of Master rial and each subserial shall be tested. Seed Virus is unsatisfactory. (3) Immediately prior to starting the (d) Master Seed Bacteria. Not less than test, frozen liquid vaccine shall be 4 ml of each lot of Master Seed Bac- thawed, and lyophilized vaccine shall teria shall be tested. Frozen liquid be rehydrated to the quantity rec- Master Seed Bacteria shall be thawed, ommended on the label using the ac- and desiccated Master Seed Bacteria companying sterile diluent or sterile shall be rehydrated with sterile puri- purified water. Product recommended fied water immediately prior to start- for mass vaccination shall be re- ing the test. hydrated at the rate of 30 ml sterile pu- (1) To test for extraneous bacteria, rified water per 1,000 doses. place 0.2 ml of the sample of Master (4) From each container sample, each of 2 plates shall be inoculated with vac- Seed Bacteria into 10 individual vessels cine equal to 10 doses if the vaccine is each containing at least 40 ml of Fluid recommended for poultry or 1 dose if Thioglycollate Medium. Incubation the vaccine is recommended for other shall be at 30 °to 35 °C for 14 days. animals. Twenty ml of medium shall be (2) To test for extraneous fungi, place added to each plate. One plate shall be 0.2 ml of the sample of Master Seed incubated at 30 °to 35 °for 7 days and Bacteria into 10 individual vessels each the other plate shall be incubated at 20 containing at least 40 ml of Soybean °to 25 °C for 14 days. Casein Digest Medium. Incubation (5) Colony counts shall be made for ° ° shall be at 20 to 25 C for 14 days. each plate at the end of the incubation (3) Examine the contents of all test period. An average colony count for the vessels macroscopically for atypical 10 samples representing the serial or microbial growth at the end of the in- subserial shall be made for each incu- cubation period. If growth of extra- bation condition. neous microorganisms cannot be reli- (6) For each set of test vessels rep- ably determined by visual examina- resenting a serial or subserial tested tion, judgment shall be confirmed by according to these procedures, the fol- subcultures, microscopic examination, lowing rules shall apply: or both. (i) If the average count at either in- (4) For each set of test vessels rep- cubation condition exceeds 1 colony per resenting a lot of Master Seed Bacteria dose for vaccines recommended for tested according to these procedures, poultry, or 10 colonies per dose for vac- the following rules shall apply: cines recommended for other animals (i) If extraneous growth is found in in the initial test, 1 retest to rule out any test vessel of the initial test, one faulty technique may be conducted retest to rule out faulty technique may using 20 unopened final containers. be conducted using a new sample of (ii) If the average count at either in- Master Seed Bacteria. cubation condition of the final test for (ii) If extraneous growth is found in a serial or subserial exceeds 1 colony any test vessel of the final test, the lot per dose for vaccines recommended for of Master Seed Bacteria is unsatisfac- poultry, or 10 colonies per dose for vac- tory. cines recommended for other animals, (e) Live viral vaccines of chicken em- the serial or subserial is unsatisfac- bryo origin recommended for adminis- tory. tration other than by parenteral injec- [48 FR 28430, June 22, 1983, as amended at 56 tion, which were not tested or have not FR 66784, Dec. 26, 1991] been found free of bacteria and fungi by the procedures prescribed in paragraph § 113.28 Detection of mycoplasma con- (a) of this section, may be tested ac- tamination. cording to the procedures prescribed in The heart infusion test, using heart this paragraph. infusion broth and heart infusion agar, (1) Brain Heart Infusion Agar shall be provided in this section shall be con- used with 500 Kinetic (Kersey) units of ducted when a test for mycoplasma penicillinase per ml of medium added contamination is prescribed in an ap- just prior to pouring the plates. plicable Standard Requirement or in

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the filed Outline of Production for the (d) The test procedure provided in product. this paragraph shall be followed when (a) Media additives provided in this conducting the mycoplasma detection paragraph shall be prepared as follows: test. (1) DPN-Cysteine Solution: (1) Preparation of inoculum. Imme- (i) Use Nicotinamide adenine diately prior to starting the test, fro- dinucleotide (oxidized) and L-Cysteine zen liquid vaccine shall be thawed, and hydrochloride. lyophilized vaccine shall be rehydrated (ii) Prepare 1 gram/100 milliliters to the volume recommended on the (ml) purified water (1 percent solution) label with mycoplasma medium. In the of each. Mix the solutions together; the case of a lyophilized biological product, cysteine reduces the DPN. Filter steri- e.g., 1,000 dose vial of poultry vaccine lize, dispense in appropriate amounts to be administered via the drinking and store frozen at ¥20 degrees centi- water, the vaccine shall be rehydrated grade. to 30 ml with mycoplasma medium. In (2) Inactivated horse serum—horse the case of a cell line or a sample of serum which has been inactivated at 56 primary cells, the inoculum shall con- °C for 30 minutes. sist of the resuspended cells. Control (b) Heart infusion broth shall be pre- tests shall be established as provided in pared as provided in this paragraph. paragraph (d)(4) of this section. (1) Dissolve in 970 ml of purified (2) Inoculation of plate. Plate 0.1 ml water, 25 grams of heart infusion broth, of inoculum on an agar plate and make 10 grams of proteose peptone No. 3, and a short, continuous streak across the either 5 grams of yeast autolysate or 5 plate with a pipet. Tilt the plate to ml of fresh yeast extract. allow the inoculum to flow over the (2) Add the following: surface. 1 percent tetrazolium chloride (ml) ...... 5.5 (3) Inoculation of flask of medium. 1 percent thallium acetate (ml) ...... 25 Penicillin (units) ...... 500,000 Transfer 1 ml of the inoculum into a Inactivated horse serum (ml) ...... 100 flask containing 100 ml mycoplasma medium and mix thoroughly. Incubate (3) Adjust pH to 7.9 with NaOH, filter the flask at 33 to 37 °C for 14 days dur- sterilize, and dispense 100 ml aliquots ing which time, one of four agar plates into 125 ml flasks and store until need- shall be streaked with 0.1 ml of mate- ed. rial from the incubating flask of inocu- (4) Add 2 ml of DPN-Cysteine solu- lated medium on the 3d day, one on the tion to each 100 ml of broth on day of use. 7th day, one on the 10th day, and one on the 14th day post-inoculation. (c) Heart Infusion Agar shall be prepared as provided in this paragraph. (4) Control tests shall be conducted (1) Dissolve in 900 ml of purified simultaneously with the detection test water by boiling the following: using techniques provided in paragraphs (d)(2) and (3) of this section, ex- Heart infusion agar (g) ...... 25 Heart-infusion broth (g) ...... 10 cept the inoculum for the positive con- Proteose peptone No. 3 (g) ...... 10 trol test shall be selected mycoplasma 1 pct thallium acetate (ml) ...... 25 cultures and the negative control test (2) Cool the medium and adjust pH to shall be uninoculated medium from the 7.9 with NaOH. same lot used in the detection test. (3) Autoclave the medium. (5) All plates shall be incubated in a (4) Cool the medium 30 minutes in a high humidity, 4–6 percent CO2 atmos- 56 °C waterbath. phere at 33 °to 37 °C for 10–14 days and (5) Dissolve 5 grams of yeast autoly- examined with a stereoscopic micro- sate in 100 ml of distilled water, filter scope at 35x to 100x or with a regular sterilize, and add to the medium. microscope at 100x. (6) Add to the medium: (e) Interpretation of test results. (1) If growth appears on at least one 126 ml of inactivated horse serum 21 ml of DPN-Cysteine solution of the plates in the positive control 525,000 units of Penicillin. test and does not appear on any of the Dispense 10 ml aliquots into 60×15 mm dis- plates in the negative control test, the posable culture dishes or petri dishes. test is valid.

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(2) If mycoplasma colonies are found (ii) After bottles have cooled, insert on any of the plates inoculated with stoppers and weigh and record the material being tested, the results are weights of the bottles as ‘‘A.’’ positive for mycoplasma contamina- (iii) Return weighing bottles to the tion. desiccator. (2) Remove the sample container [38 FR 29887, Oct. 30, 1973, as amended at 41 seal. FR 6752, Feb. 13, 1976; 41 FR 32882, Aug. 6, (i) Using a spatula, break up the sam- 1976] ple plug and transfer the required § 113.29 Determination of moisture amount of sample to the previously content in desiccated biological tared weighing bottle. products. (ii) Insert the stopper and weigh and record the weights of the weighing bot- Methods provided in this section tles as ‘‘B.’’ must be used when a determination of (3) Place the weighing bottle with the moisture content in desiccated biologi- stopper at an angle in the vacuum cal products is prescribed in an appli- oven. Set the vacuum to < 2.5 kPa and cable Standard Requirement or in the the temperature to 60 ±3 °C. filed Outline of Production for the (4) After a minimum of 3 hours of product. Firms currently using meth- drying time, turn off the vacuum pump ods other than those provided in this and allow dry air to bleed into the oven section for determining the moisture until the pressure inside the oven is content in desiccated biological prod- equalized with the prevailing atmos- ucts have until November 5, 2004 to up- pheric pressure. date their Outlines of Production to be (5) While the bottle is still warm, rein compliance with this requirement. place the stopper in its normal position (a) Final container samples of com- and transfer the weighing bottle to the pleted product shall be tested. The desiccator. weight loss of the sample due to drying (i) Allow a minimum of 2 hours for in a vacuum oven shall be determined. the weighing bottle to cool to room All procedures should be performed in temperature or for its weight to reach an environment with a relative humid- equilibrium. ity less than 45 percent. The equipment (ii) Weigh, and record the weight as necessary to perform the test is as fol- ‘‘C.’’ lows: (6) Calculate the percentage of mois- (1) Cylindrical weighing bottles with ture in the original sample as follows: airtight glass stoppers. (B¥C)/(B¥A) × (100) = Percentage of re- (2) Vacuum oven equipped with vali- sidual moisture, where: dated thermometer and thermostat. A A = tare weight of weighing bottle suitable air-drying device should be at- B¥A = weight of sample before drying tached to the inlet valve. B¥C = weight of sample after drying (3) Balance, accurate to 0.1 mg (rated (7) The results are considered satis- precision ±0.01mg). factory if the percentage of residual (4) Desiccator jar equipped with phos- moisture is less than or equal to the phorous pentoxide, silica gel, or equiv- manufacturer’s specification. alent. [68 FR 57608, Oct. 6, 2003] (5) Desiccated vaccine in original sealed vial. Sample and control should § 113.30 Detection of Salmonella con- be kept at room temperature in their tamination. original airtight containers until use. The test for detection of Salmonella (b) Test procedure: contamination provided in this section (1) Thoroughly cleaned and labeled shall be conducted when such a test is sample-weighing bottles with stoppers prescribed in an applicable Standard should be allowed to dry at 60 ±3 °C Requirement or in the filed Outline of under vacuum at less than 2.5 kPa. Production for the product. (i) Transfer hot bottles and stoppers (a) Samples shall be collected from into the desiccator and allow to cool to the bulk suspension before room temperature. bacteriostatic or bactericidal agents

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have been added. When tissue culture preparation of the questionable vaccine products are to be tested, 1 ml of tissue virus that cannot be neutralized, inac- extract used as the source of cells or 1 tivated, or separated shall be tested ml of the minced tissue per se shall be each week during the preparation of tested. such questionable vaccine. (b) Five ml of the liquid vaccine sus- (2) When cell cultures are tested, 5 ml pension shall be used to inoculate each of the final cell suspension as prepared 100 ml of liquid broth medium (tryptose for seeding of production cell cultures and either selenite F or tetrathionate). shall be used as inoculum. When vac- The inoculated media shall be incu- cines are tested, the equivalent of 200 ° bated 18–24 hours at 35–37 C. doses of Newcastle disease vaccine or (c) Transfers shall be made to either 500 doses of other vaccines for use in MacConkey agar or Salmonella- poultry, or one dose of vaccine for use Shigella agar, incubated for 18–24 hours in other animals shall be used as and examined. inoculum. Control cultures shall be (d) If no growth typical of Salmonella prepared from the same cell suspension is noted, the plates shall be incubated as the cultures for testing the vaccine. an additional 18–24 hours and again examined. (3) Uninoculated chick embryo fibro- (e) If suspicious colonies are ob- blast cell cultures shall act as negative served, further subculture on suitable controls. One set of chick fibroblast media shall be made for positive identi- cultures inoculated with subgroup A fication. If Salmonella is found, the virus and another set inoculated with bulk suspension is unsatisfactory. subgroup B virus shall act as positive controls, A and B respectively. [38 FR 29888, Oct. 30, 1973] (4) The cell cultures shall be propa- ° § 113.31 Detection of avian lymphoid gated at 35–37 C for at least 21 days. leukosis. They shall be passed when necessary to maintain viability and samples har- The complement-fixation test for de- vested from each passage shall be test- tection of avian lymphoid leukosis pro- ed for group specific antigen. vided in this section shall be conducted on all biological products containing (b) The microtiter complement-fixa- virus which has been propagated in tion test shall be performed using ei- substrates of chicken origin: Provided, ther the 50 percent or the 100 percent An inactivated viral product shall be hemolytic end point technique to de- exempt from this requirement if the li- termine complement unitage. Five 50 censee can demonstrate to Animal and percent hemolytic units or two 100 per- Plant Health Inspection Service that cent hemolytic units of complement the agent used to inactivate the vac- shall be used for each test. cine virus would also inactivate lymph- (1) All test materials, including posi- oid leukosis virus. tive and negative controls, shall be (a) Propagation of contaminating stored at ¥60 °C or colder until used in lymphoid leukosis viruses, if present, the test. Before use, each sample shall shall be done in chick embryo cell cul- be thawed and frozen three times to tures. disrupt intact cells and release the (1) Each vaccine virus, cytopathic to group specific antigen. chick embryo fibroblast cells, shall be (2) The antiserum used in the effectively neutralized, inactivated, or microtiter complement-fixation test separated so that minimal amounts of shall be a standard reagent supplied or lymphoid leukosis virus can be propa- approved by the Animal and Plant gated on cell culture during the 21-day Health Inspection Service. Four units growth period. If a vaccine virus can- of antiserum shall be used for each not be effectively neutralized, inac- test. tivated, or separated, a sample of an- (3) Presence of complement-fixing ac- other vaccine prepared the same week tivity in the harvested samples (from from material harvested from each passages) at the 1:4 or higher dilution, source flock (or other sampling proce- in the absence of anticomplementary dure acceptable to Animal and Plant activity, shall be considered a positive Health Inspection Service) used for the test unless the activity can definitely

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be established to be caused by some- or toxic for the animals for which it is thing other than lymphoid leukosis recommended, the licensee shall dem- virus, subgroups A and/or B. Activity onstrate the safety of such product by at the 1:2 dilution shall be considered an acceptable test written into such suspicious and the sample further sub- Outline of Production. cultured to determine presence or ab- (a) Final container samples of com- sence of the group specific antigen. pleted product from live virus vaccines (4) Biological products or primary shall be tested for safety using young cells which are found contaminated adult mice in accordance with the test with lymphoid leukosis viruses are un- provided in this paragraph. satisfactory. Source flocks from which (1) Vaccine prepared for use as rec- contaminated material was obtained ommended on the label shall be tested are also unsatisfactory. by inoculating eight mice [38 FR 29888, Oct. 30, 1973, as amended at 38 intraperitoneally or subcutaneously FR 32917, Nov. 29, 1973; 39 FR 21042, June 18, with 0.5 mL (the inoculation volume 1974; 56 FR 66784, Dec. 26, 1991] may be divided among more than one § 113.32 Detection of Brucella contami- injection site), and the animals ob- nation. served for 7 days. The test for detection of Brucella (2) If unfavorable reactions attrib- contamination provided in this section utable to the product occur in any of shall be conducted when such a test is the mice during the observation period, prescribed in an applicable Standard the serial or subserial is unsatisfac- Requirement or in a filed Outline of tory. If unfavorable reactions which Production for the product. are not attributable to the product (a) One ml of the minced tissue used occur, the test shall be declared incon- as the source of cells or 1 ml of the exclusive and may be repeated: Provided, tract of the tissue prior to the addition That, if the test is not repeated, the se- of antibiotics, diluent and stabilizer, rial or subserial shall be declared un- shall be inoculated onto each of three satisfactory. tryptose agar plates and incubated in a (b) Bulk or final container samples of 10 percent CO2 atmosphere at a tem- completed product from liquid prod- perature of 35–37 °C for at least 7 days. ucts, such as but not limited to (b) If colonies are identified as antiserums and bacterins, shall be test- Brucella, the biological product is un- ed for safety in accordance with the satisfactory. test provided in this paragraph. (c) If colonies suspicious of Brucella (1) Unless otherwise prescribed in the are observed but cannot be identified Standard Requirement or approved in a as a Brucella species, either filed Outline of Production for the (1) The biological product shall be re- product, a 0.5 ml dose shall be injected garded as unsatisfactory and de- intraperitoneally or subcutaneously stroyed; or (2) Further subculture or other proce- into eight mice and the animals ob- dures shall be carried out until a posi- served for 7 days. tive identification can be made. (2) If unfavorable reactions attributable to the product occur in any of [38 FR 29888, Oct. 30, 1973] the mice during the observation period, § 113.33 Mouse safety tests. the serial or subserial is unsatisfactory. If unfavorable reactions which One of the mouse safety tests pro- are not attributable to the product vided in this section shall be conducted occur, the test shall be declared incon- when such test is prescribed in a clusive and may be repeated: Provided, Standard Requirement or in the filed That, if the test is not repeated, the se- Outline of Production for a biological rial or subserial shall be declared un- product recommended for animals other than poultry: Provided, That if satisfactory. the inherent nature of one or more in- [38 FR 34727, Dec. 18, 1973, as amended at 39 gredients makes the biological product FR 16857, May 10, 1974; 72 FR 72564, Dec. 21, lethal or toxic for mice but not lethal 2007]

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§ 113.34 Detection of hemagglutinating biological product used as diluent for a viruses. desiccated live virus vaccine in a com- The test for detection of bination package. hemagglutinating viruses provided in (a) Bulk or final container samples of this section shall be conducted when completed product from each serial such a test is prescribed in an applica- shall be tested. ble Standard Requirement or in the (b) The product shall be tested with filed Outline of Production for the each virus fraction for which it is to be product. used as a diluent. If the vaccine to be (a) Final container samples of com- rehydrated contains more than one pleted product rehydrated as rec- virus fraction, the test shall be con- ommended on the label shall be used as ducted with each fraction after neu- inoculum: Provided, That poultry vac- tralization of the other fraction(s), and/ cines distributed without diluent shall or dilution of the vaccine beyond the be rehydrated with 30 ml of sterile dis- titer range of the other fraction(s), or tilled water per 1,000 doses and used as the test shall be conducted using rep- inoculum. When one or more fractions resentative single-fraction desiccated are to be used in combination with vaccines which are prepared by the li- Newcastle Disease Vaccine, test sam- censee and which are licensed. Pro- ples shall be collected from bulk sus- vided, That the Administrator may au- pensions of each prior to mixing with thorize licensees to prepare and use un- the Newcastle Disease Vaccine. licensed single-fraction vaccines for (b) Each of ten 9- to 10-day-old this purpose. embryonating eggs from Newcastle dis- (c) Test procedure: (1) Rehydrate at ease susceptible flocks shall be inocu- least two vials of the vaccine with the lated into the allantoic cavity with 0.2 liquid product under test according to ml of the undiluted inoculum. label recommendations and pool the (1) Test five uninoculated embryos of contents. the same age and from the same flock (2) Rehydrate at least two vials of as those used for the test as negative the vaccine with the same volume of controls. sterile purified water and pool the con- (2) Test an allantoic fluid sample of tents. Newcastle disease virus as a positive (3) Neutralize to remove other frac- control. tions, if necessary. (c) Three to five days post-inocula- (4) Hold the two pools of vaccine at tion, a sample of allantoic fluid from room temperature (20 °to 25 °C) for 2 each egg shall be tested separately by a hours. The holding period shall begin rapid plate test for hemagglutinating when rehydration is completed. activity using a 0.5 percent suspension (5) Titrate the virus(es) in each pool of fresh chicken red blood cells. of vaccine as provided in the filed Out- (d) If the results are inconclusive, line of Production or an applicable one or two blind passages shall be made standard requirement. using fluids from each of the original (6) Compare respective titers. test eggs. Fluids from dead and live (d) If the titer of the vaccine virus(es) embryos may be pooled separately for rehydrated with the product under test inoculum in these passages. is more than 0.7 log10 below the titer of (e) If hemagglutinating activity at- the vaccine virus(es) rehydrated with tributable to the product is observed, sterile purified water, the product is the serial is unsatisfactory. unsatisfactory for use as diluent. [38 FR 29889, Oct. 30, 1973] (e) If the product is unsatisfactory in the first test, one retest to rule out § 113.35 Detection of viricidal activity. faulty techniques may be conducted The test for detection of viricidal ac- using four vials of the vaccine for each tivity provided in this section shall be pool and the acceptability of the prod- conducted when such a test is pre- uct judged by the results of the second scribed in an applicable standard retest. quirement or in the filed Outline of (f) Liquid products found to be unsat- Production for each inactivated liquid isfactory for use as diluent by this test

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are not prohibited from release as sepa- tested shall be considered unsatisfac- rate licensed products if labeled as pre- tory. scribed in § 112.7(g). [38 FR 29889, Oct. 30, 1973, as amended at 39 [44 FR 25412, May 1, 1979, as amended at 56 FR 21042, June 18, 1974; 43 FR 7610, Feb. 24, FR 66784, Dec. 26, 1991; 64 FR 43044, Aug. 9, 1978] 1999] § 113.37 Detection of pathogens by the chicken embryo inoculation test. § 113.36 Detection of pathogens by the chicken inoculation test. The test for detection of extraneous pathogens provided in this section The test for detection of extraneous shall be conducted when such a test is pathogens provided in this section prescribed in an applicable Standard shall be conducted when such a test is Requirement or in the filed Outline of prescribed in an applicable Standard Production for the product. Requirement or in the filed Outline of (a) The biological product to be test- Production for the product. ed shall be prepared for use as rec- (a) The biological product to be test- ommended on the label, or in the case ed shall be prepared for use as rec- of desiccated vaccine to be used in ommended on the label, or in the case poultry, rehydrated with sterile dis- of desiccated vaccine to be used in tilled water at the rate of 30 ml per poultry, rehydrated with sterile dis- 1,000 doses. tilled water at the rate of 30 ml per (b) One volume of the prepared vac- 1,000 doses. cine shall be mixed with up to nine volumes of sterile heat-inactivated spe- (b) At least 25 healthy susceptible cific antiserum to neutralize the vac- young chickens, properly identified and cine virus in the product. Each lot of obtained from the same source and antiserum shall be demonstrated by hatch, shall be immunized at least 14 virus neutralization tests not to in- days prior to being put on test. The im- hibit other viruses known to be pos- munizing agent shall be the same as sible contaminants. the product to be tested but from a se- (c) After neutralization, 0.2 ml of the rial previously tested and found satis- vaccine-serum mixture shall be inocu- factory. lated into each of at least 20 fully sus- (c) At least 20 of the previously im- ceptible chicken embryos. munized birds shall be inoculated with (1) Twenty embryos, 9 to 11 days old, 10 label doses of the vaccine being test- shall be inoculated on the chorio- ed by each of the following routes: Sub- allantoic membrane (CAM) with 0.1 ml, cutaneous, intratracheal, eye-drop, and and in the allantoic sac with 0.1 ml. comb scarification (1 cm2). Twenty (2) Eggs shall be candled daily for 7 birds may be used for each route or days. Deaths occurring during the first combination of routes. 24 hours shall be disregarded but at least 18 viable embryos shall survive 24 (d) At least five birds shall be iso- hours post-inoculation for a valid test. lated as control birds. Examine all embryos and CAM’s from (e) All birds shall be observed for 21 embryos which die after the first day. days for signs of septicemic diseases, When necessary, embryo subcultures respiratory diseases, or other shall be made to determine the cause of pathologic conditions. a death. The test shall be concluded on (f) If the controls remain healthy and the seventh day post-inoculation and unfavorable reactions attributable to the surviving embryos (including the product occur in the vaccinates, CAM’s) examined. the serial or subserial tested is unsatis- (d) If death and/or abnormality at- factory. If the controls do not remain tributable to the inoculum occur, the healthy or if unfavorable reactions not serial is unsatisfactory: Provided, That, attributable to the product occur in if there is a vaccine virus override, the the vaccinates, or both, the test shall test may be repeated, using a higher be declared inconclusive and may be titered antiserum. repeated: Provided, That, if the test is [38 FR 29889, Oct. 30, 1973, as amended at 39 not repeated, the serial of subserial FR 21042, June 18, 1974]

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§ 113.38 Guinea pig safety test. in a 50 percent plaque reduction test or other serum-neutralization test of The guinea pig safety test provided equal sensitivity. in this section shall be conducted when (iii) When determining susceptibility prescribed in a Standard Requirement to a virus which does not lend itself to or approved Outline of Production for a the methods in paragraphs (a)(1)(i) and biological product. When desiccated (ii) of this section, a method acceptable products are tested, final container to Animal and Plant Health Inspection samples of completed product prepared Service shall be used. for administration in the manner rec- (2) Each of at least 10 susceptible cats ommended on the label shall be used. shall be administered a sample of the When liquid products are tested, either Master Seed Virus equivalent to the bulk or final container samples of com- amount of virus to be used in one cat pleted product shall be used. dose of the vaccine, by the method to (a) Unless otherwise specified in the be recommended on the label, and the Standard Requirement or approved cats observed each day for 14 days. Outline of Production for the product, (3) If unfavorable reactions attrib- a 2 ml dose shall be injected either utable to the virus occur in any of the intramuscularly or subcutaneously cats during the observation period, the into each of two guinea pigs and the Master Seed Virus is unsatisfactory. If animals observed for 7 days. unfavorable reactions occur which are (b) If unfavorable reactions attrib- not attributable to the Master Seed utable to the product occur in either of Virus, the test shall be declared incon- the guinea pigs during the observation clusive and repeated: Provided, That, if period, the serial or subserial is unsat- not repeated, the Master Seed Virus isfactory. If unfavorable reactions shall be unsatisfactory. which are not attributable to the prod- (b) The cat safety test provided in uct occur, the test shall be declared in- this paragraph shall be used when a se- conclusive and may be repeated: Pro- rial of vaccine is tested for safety be- vided, That, if the test is not repeated, fore release. the serial or subserial shall be declared (1) Each of two healthy cats shall be unsatisfactory. administered 10 cat doses by the meth- [39 FR 16857, May 10, 1974; 39 FR 20368, June od recommended on the label and the 10, 1974] cats observed each day for 14 days. (2) If unfavorable reactions attrib- § 113.39 Cat safety tests. utable to the biological product occur The safety tests provided in this sec- during the observation period, the se- tion shall be conducted when pre- rial is unsatisfactory. If unfavorable scribed in a standard requirement or in reactions occur which are not attrib- the filed Outline of Production for a bi- utable to the product, the test shall be ological product recommended for use declared inconclusive and repeated: in cats. Provided, That, if not repeated, the se- (a) The cat safety test provided in rial shall be unsatisfactory. this paragraph shall be used when the [44 FR 58898, Oct. 12, 1979, as amended at 56 Master Seed Virus is tested for safety. FR 66784, Dec. 26, 1991] (1) The test animals shall be determined to be susceptible to the virus § 113.40 Dog safety tests. under test as follows: The safety tests provided in this sec- (i) Throat swabs shall be collected tion shall be conducted when pre- from each cat and individually tested scribed in a Standard Requirement or on susceptible cell cultures for the in the filed Outline of Production for a presence of the virus. Blood samples biological product recommended for shall also be drawn and individual use in dogs. Serials which are not serum samples tested for antibody to found to be satisfactory when tested the virus. pursuant to the procedures in this sec- (ii) The cats shall be considered sus- tion may not be released for shipment. ceptible if swabs are negative for virus (a) The dog safety test provided in isolation and the serums are free of this paragraph shall be used when the virus antibody at the 1:2 final dilution Master Seed Virus is tested for safety.

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(1) The test animals shall be deter- unsatisfactory. If unfavorable reac- mined to be susceptible to the virus tions which are not attributable to the under test by a method acceptable to product occur, the test shall be de- the Animal and Plant Health Inspec- clared inconclusive and may be re- tion Service. peated: Provided, That, if the test is not (2) Each of at least 10 susceptible repeated, the serial or subserial shall dogs shall be administered a sample of be declared unsatisfactory. the Master Seed Virus equivalent to the amount of virus to be used in one [39 FR 27428, July 29, 1974] dog dose of the vaccine, by the method recommended on the label, and the dog § 113.42 Detection of lymphocytic choriomeningitis contamination. shall be observed each day for 14 days. (3) If unfavorable reactions attrib- The test for detection of lymphocytic utable to the virus occur in any of the choriomeningitis (LCM) virus provided dogs during the observation period, the in this section shall be conducted when Master Seed Virus is unsatisfactory. If such a test is prescribed in an applica- unfavorable reactions occur which are ble Standard Requirement or in a filed not attributable to the Master Seed Outline of Production. Vaccine virus Virus, the test shall be declared incon- may be neutralized with specific anti- clusive and may be repeated: Provided: serum when necessary. That, if the test is not repeated, the (a) Each of at least 10 mice obtained Master Seed Virus shall be considered from a source free of LCM shall be in- unsatisfactory. jected in the footpad of a hindfoot with (b) The dog safety test provided in 0.02 ml of the material being tested and this paragraph shall be used when a se- observed each day for 21 days. rial of vaccine is tested for safety be- (b) If any of the mice show swelling fore release. in the injected footpad or if more than (1) Each of two healthy dogs shall be one becomes systemically abnormal, administered 10 dog doses by the meth- the material being tested is unsatisfac- od recommended on the label and the tory. dogs shall be observed each day for 14 days. [42 FR 6794, Feb. 4, 1977] (2) If unfavorable reactions attributable to the biological product occur § 113.43 Detection of chlamydial during the observation period, the se- agents. rial is unsatisfactory. If unfavorable The test for chlamydial agents pro- reactions occur which are not attrib- vided in this section shall be conducted utable to the biological product, the when such a test is prescribed in an ap- test shall be declared inconclusive and plicable standard requirement or in a may be repeated: Provided, That, if the filed Outline of Production. test is not repeated, the serial shall be (a) The yolk sac of 6-day-old chicken considered unsatisfactory. embryos shall be injected. Three [60 FR 14358, Mar. 17, 1995] groups of 10 embryos shall be used sequentially. § 113.41 Calf safety test. (1) The inoculum for each embryo in The calf safety test provided in this the first group shall consist of 0.5 ml of section shall be conducted when pre- a mixture of equal parts of the seed scribed in a Standard Requirement or virus with phosphate buffered saline in the filed Outline of Production for a that may contain Streptomycin, product. Vancomycin, Kanamycin, or a com- (a) Test procedure. Each of two calves bination thereof. Not more than 2 mg/ shall be injected with the equivalent of ml of each antibiotic shall be used. 10 doses of vaccine administered in the (2) On the 10th day postinoculation, manner recommended on the label and the yolk sac of viable embryos shall be observed each day for 21 days. harvested, pooled, homogenized as a 20 (b) Interpretation. If unfavorable reac- percent suspension in phosphate tions attributable to the product occur buffered saline antibiotic diluent, and in either of the calves during the obser- 0.5 ml of the mixture injected into the vation period, the serial or subserial is second group of chicken embryos. This

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process shall be repeated for the injec- which the product is recommended tion of the third group of embryos with the equivalent of two doses of bac- using the yolk sacs of viable embryos terial vaccine or 10 doses of viral vac- from the second group. cine. (3) For each of the three passages, (2) Administer vaccine in the manner embryo deaths occurring within 48 recommended on the label. hours of injection shall be disregarded, (3) Observe sheep each day for 21 except that if more than three such days. deaths occur at any passage, that pas- (b) Interpretation. If unfavorable reac- sage shall be repeated. tions attributable to the product occur (b) If one or more embryo deaths in either of the sheep during the obser- occur at any passage after 48 hours vation period, the serial or subserial is postinjection, the yolk sacs from each unsatisfactory. If unfavorable reac- of the dead embryos shall be subcul- tions which are not attributable to the tured into 10 additional embryos. If one product occur, the test shall be de- or more embryo deaths again occur due clared inconclusive and may be re- to chlamydial agents, the Master Seed peated; Provided, That, if the test is not Virus is unsatisfactory for use to repeated, the serial or subserial shall produce vaccine. be declared unsatisfactory. [44 FR 58899, Oct. 12, 1979] [48 FR 33476, July 22, 1983]

§ 113.44 Swine safety test. § 113.46 Detection of cytopathogenic and/or hemadsorbing agents. The swine safety test provided in this section shall be conducted when pre- The tests for detection of scribed in a Standard Requirement or cytopathogenic and/or hemadsorbing in the filed Outline of Production for a agents provided in this section shall be product. conducted when prescribed in an appli- (a) Test procedure. (1) Inject each of cable Standard Requirement or in the two swine of the minimum age for filed Outline of Production for a prod- which the product is recommended uct. with the equivalent of two doses of bac- (a) Test for cytopathogenic agents. One terial vaccine or 10 doses of viral vac- or more monolayers that are at least 6 2 cine. cm and at least 7 days from the last (2) Administer vaccine in the manner subculture shall be tested as provided recommended on the label. in this paragraph. (3) Observe swine each day for 21 (1) Stain each monolayer with a suit- days. able cytological stain. (b) Interpretation. If unfavorable reac- (2) Examine the entire area of each tions attributable to the product occur stained monolayer for evidence of in- in either of the swine during the obser- clusion bodies, abnormal number of vation period, the serial or subserial is giant cells, or other cytopathology in- unsatisfactory. If unfavorable reac- dicative of cell abnormalities attrib- tions which are not attributable to the utable to an extraneous agent. product occur, the test shall be de- (b) Test for hemadsorbing agents. One clared inconclusive and may be re- or more monolayers that are at least 6 2 peated; Provided, That, if the test is not cm and at least 7 days from the last repeated, the serial or subserial shall subculture shall be tested as provided be declared unsatisfactory. in this paragraph. (1) Wash the monolayer with several [48 FR 33476, July 22, 1983] changes of phosphate buffered saline. (2) Add an appropriate volume of a 0.2 § 113.45 Sheep safety test. percent red blood cell suspension to The sheep safety test provided in this uniformly cover the surface of the section shall be conducted when pre- monolayer of cultured cells. Suspen- scribed in a Standard Requirement or sions of washed guinea pig and chicken in the filed Outline of Production for a red blood cells shall be used. These sus- product. pensions may be mixed before addition (a) Test procedure. (1) Inject each of to the monolayer or they may be added two sheep of the minimum age for separately to individual monolayers.

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(3) Incubate the monolayer at 4 °C for (whichever is applicable), shall be pre- 30 minutes, wash with phosphate pared as negative controls. buffered saline, and examine for (2) Each group of monolayers shall hemadsorption. have a total area of at least 6 cm2. (4) If no hemadsorption is apparent, (3) Positive control monolayers may repeat step (b)(2) of this section and in- be fixed (processed so as to arrest cubate the monolayers at 20–25 °C for 30 growth and assure attachment of the minutes, wash with phosphate buffered monolayer to the surface of the vessel saline, and examine again for in which they are grown) before 7 days hemadsorption. If desired, separate after subculturing if fluorescence is en- monolayers may be used for each incu- hanced by doing so, Provided, That a bation temperature. monolayer of the material under test is (c) If specific cytopathology or also fixed at the same time as the posi- hemadsorption attributable to an ex- tive control and a monolayer of the traneous agent is found, the material material under test is also fixed at under test is unsatisfactory and shall least seven days after subculturing. not be used to prepare biological prod- Monolayers that are fixed before 7 days ucts. If an extraneous agent is sus- after subculturing shall be stained at pected because of cytopathology or the same time as the test monolayers hemadsorption and cannot be elimi- and negative controls fixed at least 7 nated as a possibility by additional days after subculturing. testing, the material under test is un- (b) The antiviral fluorochrome-con- satisfactory. jugated antibodies to be used shall depend on the type of cells required to be [50 FR 441, Jan. 4, 1985, as amended at 58 FR tested for extraneous viruses as speci- 50252, Sept. 27, 1993] fied in an applicable Standard Require- ment or in a filed Outline of Produc- § 113.47 Detection of extraneous viruses by the fluorescent antibody tion. Antiviral fluorochrome-con- technique. jugated antibodies specific for the extraneous viruses shall be applied to The test for detection of extraneous each respective type of cell in accord- viruses by the fluorescent antibody ance with the following list. Under cer- technique provided in this section shall tain circumstances, additional tests be conducted when prescribed in an ap- may need to be conducted, as deter- plicable Standard Requirement or in a mined by the Administrator. When a filed Outline of Production for a prod- specific antiviral fluorochrome-con- uct. jugated antibody is used in testing for (a) Monolayer cultures of cells the listed extraneous viruses specified (monolayers), at least 7 days after the in more than one cell type, it need only last subculturing, shall be processed be applied to the most susceptible cell and stained with the appropriate type. antiviral fluorochrome-conjugated (1) All cells shall be tested for: antibody as specified in paragraph (b) (i) Bovine virus diarrhea virus; of this section. (ii) Reovirus; and (1) Three groups of one or more (iii) Rabies virus. monolayers shall be required for each (2) Bovine, caprine, and ovine cells specific virus prescribed in paragraph shall, in addition, be tested for: (b) of this section. (i) Bluetongue virus; (i) At the time of the last subcul- (ii) Bovine adenoviruses; turing, one group of test monolayers (iii) Bovine parvovirus; and shall be inoculated with approximately (iv) Bovine respiratory syncytial 100–300 FAID50 of the specific virus virus. being tested for as positive controls. (3) Canine cells shall, in addition, be (ii) One group of monolayers shall be tested for: the ‘‘material under test.’’ (i) Canine coronavirus; (iii) One group of monolayers, that (ii) Canine distemper virus; and are of the same type of cells as the test (iii) Canine parvovirus. monolayers and that have been tested (4) Equine cells shall, in addition, be as prescribed in §§ 113.51 or 113.52 tested for:

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(i) Equine herpesvirus; and dose of the product shall not be toxic (ii) Equine viral arteritis virus. to the recipient; and in the combina- (5) Feline cells shall, in addition, be tions used shall not denature the spe- tested for: cific substances in the product below (i) Feline infectious peritonitis virus; the minimum acceptable potency with- and in the dating period when stored at the (ii) Feline panleukopenia virus. recommended temperature. (6) Porcine cells shall, in addition, be tested for: [38 FR 29889, Oct. 30, 1973] (i) Porcine adenovirus; (ii) Porcine parvovirus; § 113.51 Requirements for primary cells used for production of bio- (iii) transmissible gastroenteritis logics. virus; and (iv) Porcine hemagglutinating en- Primary cells used to prepare bio- cephalitis virus. logical products shall be derived from (7) Firms that do not have rabies normal tissue of healthy animals. virus on premises either for research or When prescribed in an applicable production purposes are exempt from Standard Requirement or in the filed having to produce positive rabies virus Outline of Production, each batch of control monolayers. Fixed positive ra- primary cells used to prepare a biologi- bies virus control monolayers will be cal product shall be tested as pre- provided by the National Veterinary scribed in this section. A batch of pri- Services Laboratories. mary cells found unsatisfactory by any (c) After staining, each group of prescribed test shall not be used. A se- monolayers shall be examined for the rial of biological product shall not be presence of specific fluorescence attrib- released if produced from primary cells utable to the presence of extraneous vi- that are found unsatisfactory by any ruses. prescribed test. (1) If the material under test shows (a) Final container samples of com- any evidence of specific viral fluores- pleted product or samples of the final cence, it is unsatisfactory and may not pool of harvested material or samples be used; Provided, That, if specific fluo- of each subculture of cells used to pre- rescence attributable to the virus being pare the biological product shall be tested for is absent in the positive con- shown free of mycoplasma as pre- trol monolayers, the test is inconclu- scribed in § 113.28. The sample for test- sive and may be repeated. ing shall consist of at least 75 cm2 of (2) If the fluorescence of the actively growing cells or the equiva- monolayers inoculated with the spe- lent in harvest fluids; Provided, That cific virus as positive controls is equiv- all sources of cells in the batch of pri- ocal, or if the negative monolayers mary cells are represented. show equivocal fluorescence indicating (b) Final container samples of com- possible viral contamination, or both, pleted product or samples of the final the test shall be declared inconclusive, pool of harvested material or samples and may be repeated; Provided, That, if of each subculture of cells used to pre- the test is not repeated, the material pare the biological product shall be under test shall be regarded as unsatis- shown free of bacteria and fungi as pre- factory for use in the production of bio- scribed in § 113.26 or § 113.27 (whichever logics. is applicable). 2 [60 FR 24548, May 9, 1995] (c) A monolayer at least 75 cm from each batch of primary cells or each INGREDIENT REQUIREMENTS subculture of primary cells used to prepare a biological product shall be § 113.50 Ingredients of biological prod- shown free of extraneous agents as pre- ucts. scribed in this paragraph. All ingredients used in a licensed bio- (1) The test monolayer shall be main- logical product shall meet accepted tained using the medium (with addi- standards of purity and quality; shall tives) and under conditions similar to be sufficiently nontoxic so that the those used to prepare biological prod- amount present in the recommended ucts.

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(i) Monolayers of avian origin shall highest passage level (MCS + n) in- be maintained for at least 14 days and tended for use in the preparation of a shall be subcultured at least once dur- biological product shall be specified in ing the maintenance period. All but the the Outline of Production for the prod- last subculture shall result in a new uct. monolayer of at least 75 cm2. The last (3) Sufficient 1.0 ml or larger aliquots subculture shall meet the minimum of MCS and MCS + n shall be prepared, area requirement specified in §§ 113.46 kept in a frozen state, and made avail- and 113.47. able to Animal and Plant Health In- (ii) Monolayers not of avian origin spection Service (APHIS) upon request shall be maintained for at least 28 days for performing the tests prescribed in and shall be subcultured at least twice this section. during the maintenance period. All but (4) Each lot of cells shall be mon- the last subculture shall result in a itored for the characteristics deter- new monolayer of at least 75 cm2. The mined to be normal for the cell line, last subculture shall meet the min- such as, but not limited to, micro- imum area requirement specified in scopic appearance, growth rate, acid §§ 113.46 and 113.47. production, or other observable fea- (2) Monolayers shall be examined reg- tures. ularly throughout the required mainte- (b) The MCS shall be shown to be of nance period for evidence of the pres- the same species of origin as that re- ence of cytopathogenic agents. If evi- ported in paragraph (a)(1) of this sec- dence of a cytopathogenic agent is tion by the following method: found, the batch of primary cells is un- (1) At least four monolayers with a satisfactory. total area of at least 6 cm2 shall be (3) At the conclusion of the required grown to at least 80 percent maintenance period, monolayers shall confluency. be tested for: (2) The monolayers shall be removed (i) Cytopathogenic and/or from their media, processed, stained, hemadsorbing agents as prescribed in and examined. § 113.46; (i) At least two monolayers shall be (ii) Extraneous viruses by the fluo- stained with an antispecies rescent antibody technique as pre- fluorchrome-conjugated antibody unre- scribed in § 113.47. lated to the species of origin of the [50 FR 442, Jan. 4, 1985, as amended at 60 FR MCS. 24549, May 9, 1995] (ii) At least two monolayers shall be stained with an antispecies § 113.52 Requirements for cell lines fluorochrome-conjugated antibody spe- used for production of biologics. cific to the species of origin of the When prescribed in an applicable MCS. Standard Requirement or in a filed (iii) All monolayers shall be exam- Outline of Production each cell line ined for evidence of specific fluores- used to prepare a biological product cence. shall be tested as prescribed in this sec- (3) If specific fluorescence is not tion. A cell line found unsatisfactory found in the monolayers stained with by any prescribed test shall not be the conjugate specific to the species of used. A serial of biological product origin of the MCS, the cell line is un- shall not be released if produced from a satisfactory and shall not be used for cell line that is found unsatisfactory vaccine production. by any prescribed test. (4) If nonspecific fluorescence is (a) General requirements. (1) A com- found in the monolayers stained with plete record of the cell line shall be conjugate from an unrelated species of kept, such as, but not limited to, the origin or other results make the test source, passage history, and medium results equivocal, the procedure shall used for propagation. be repeated until either specific fluo- (2) A Master Cell Stock (MCS) shall rescence is found only in the be established at a specified passage monolayers stained with conjugate spe- level for each cell line. The passage cific to the species of origin of the MCS level and identity of the MCS and the and not in the control monolayers or

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specific fluorescence cannot be identi- (i) Cytopathogenic and/or fied and the MCS is declared unsatis- hemadsorbing agents as prescribed in factory. § 113.46; and (5) Alternate tests to determine the (ii) Extraneous agents by the fluores- species of origin of the MCS may be cent antibody technique as prescribed used if approved by APHIS. in § 113.47. (c) The MCS and either each subcul- (f) At the conclusion of the 21-day ture of cells used to prepare a biologi- maintenance period provided in para- cal product or the final pool of har- graph (e) of this section, at least one vested material (with or without the monolayer of at least 75 cm2 shall also stabilizer) or final container samples of be shown free of extraneous agents as completed product for each serial of prescribed in this paragraph. such product shall be shown to be free of mycoplasma as prescribed in § 113.28. (1) Alternately freeze and thaw the The sample for testing shall consist of monolayer(s) three times. Centrifuge at least 75 cm2 of actively growing cells the disrupted cells at no greater than × or the equivalent, in harvest fluids. 2,000 g for no more than 15 minutes to The cells shall represent all sources of remove cellular debris. Divide the su- cells in the batch. pernatant into equal aliquots and dis- (d) The MCS and either each subcul- pense 1.0 ml onto each of at least one ture used to prepare a biological prod- monolayer (at least 75 cm2) of: uct or the final pool of harvested mate- (i) Vero (African green monkey kid- rial for each serial of such product or ney) cell line; final container samples of completed (ii) Embryonic cells, neonatal cells, product for each serial of such product or a cell line of the same species of ori- shall be tested for bacteria and fungi as gin as the MCS if different than pro- prescribed in § 113.26 or § 113.27 (which- vided in paragraph (f)(1)(i) of this sec- ever is applicable). If bacteria or fungi tion; are found in the MCS, the MCS shall (iii) Embryonic cells, neonatal cells, not be used. If bacteria or fungi are or a cell line of the species for which found in a subculture, the subculture the vaccine is recommended if different shall not be used. than provided in paragraph (f)(1)(ii) of (e) A monolayer at least 75 cm2 from this section; and each MCS shall be shown free of extra- (iv) Embryonic cells, neonatal cells, neous agents as prescribed in this para- or a cell line of bovine origin if not graph. specified in paragraphs (f)(1)(ii), and (1) The test monolayer shall be main- (iii) of this section. tained for at least 21 days using the (2) The monolayers of cells specified medium (with additives) intended for in paragraphs (f)(1)(i), (ii), (iii), and (iv) growth and maintenance and under of this section shall be maintained for conditions similar to those used to pre- at least 14 days after inoculation with pare biological products. the aliquot of disrupted MCS. (2) Cells shall be subcultured at least Monolayers shall be subcultured at two times during the maintenance pe- least once during the maintenance period. All but the last subculture shall result in at least one new monolayer of riod. All but the last subculture shall at least 75 cm2. The last subculture result in a new monolayer of at least 75 2 shall meet the minimum area require- cm . The last subculture shall meet the ment specified in §§ 113.46 and 113.47 and minimum area requirement specified in paragraph (f) of this section. §§ 113.46 and 113.47. (3) Monolayers shall be examined reg- (3) Monolayers shall be examined regularly throughout the 21-day mainte- ularly throughout the 14-day maintenance period for evidence of the pres- nance period for evidence of the presence of cytopathogenic agents. If evi- ence of cytopathogenic agents. If evidence of a cytopathogenic agent is dence of a cytopathogenic agent is found, the MCS is unsatisfactory. found, the MCS is unsatisfactory. (4) At the conclusion of the 21-day (4) At the conclusion of the 14-day maintenance period, monolayers shall maintenance period, monolayers shall be tested for: be tested for:

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(i) Cytopathogenic and/or of mycoplasma by the method pre- hemadsorbing agents as prescribed in scribed in § 113.28. § 113.46; and (b) Samples of each lot of ingredient (ii) Extraneous viruses by the fluo- or animal origin which is not subjected rescent antibody technique as pre- to heat sterilization of other steriliza- scribed in § 113.47. tion methods acceptable to APHIS used (g) The karyology of cells lines used to prepare a biological product shall be in the production of biologics shall be shown free of bacteria and fungi as pre- examined as follows. A minimum of 50 scribed in § 113.26. mitotic cells shall be examined at both (c) Samples of each lot of ingredient the MCS and MCS+n. The modal num- of animal origin, except porcine ber in the MCS+n shall not exceed plus trypsin, which is not subjected to heat or minus 15 percent of the modal num- sterilization or other viricidal proce- ber of the MCS. Any marker chro- dure acceptable to APHIS used in the mosomes present in the MCS shall per- preparation of biological products shall sist at the MCS+n. If the modal num- be tested as prescribed in this para- ber exceeds the limits and/or the mark- graph; er chromosomes do not persist (1) Monolayers at least 75 cm2 of Vero (through the MCS+n passage level), the (African green monkey kidney) cell cell line shall not be used for vaccine line and of primary cells or a cell line production. of the same species of origin as the in- (h) If direct or indirect evidence ex- gredient shall be used in the test. Cell ists that a cell line which is intended lines used shall have been found satis- for use in the preparation of a vaccine factory when tested as prescribed in may induce malignancies in the species § 113.52 and primary cells used shall for which the product is intended, that have been found satisfactory when cell line shall be tested for tested as prescribed in § 113.51. tumorigenicity/oncogenicity by a method acceptable to APHIS. (2) At least 3.75 ml or 15 percent of the ingredient shall be used in the [50 FR 442, Jan. 4, 1985; 50 FR 3316, Jan. 24, growth medium for the preparation of 1985, as amended at 56 FR 66784, Dec. 26, 1991; at least 75 cm2 test monolayers. The in- 60 FR 24549, May 9, 1995] gredient shall also be used in the § 113.53 Requirements for ingredients growth medium when monolayers are of animal origin used for produc- subcultured. If the ingredient being tion of biologics. tested is cytotoxic when tested in this manner, other procedures may be used Each lot of ingredient of animal ori- if approved by APHIS. gin which is not subjected to heat sterilization or other sterilization methods (3) The test monolayers shall be acceptable to Animal and Plant Health maintained for at least 21 days. Inspection Service (APHIS), such as, (4) Cells shall be subcultured at least but not limited to serum and albumin, two times during the maintenance pe- used to prepare a biological product riod. All but the last subculture shall shall be tested as prescribed in this sec- result in at least one new monolayer of tion by the licensee or a laboratory ac- at least 75 cm2. The last subculture ceptable to VS. Results of all tests shall meet the minimum area require- shall be recorded by the testing labora- ments specified in §§ 113.46 and 113.47. tory and made a part of the licensee’s (5) Monolayers shall be examined reg- records. A lot of ingredient found un- ularly throughout the 21-day mainte- satisfactory by any prescribed test nance period for evidence of shall not be used to prepare a biologi- cytopathogenic agents. If evidence of a cal product. A serial of biological prod- cytopathogenic agent is found, the in- uct shall not be released if produced gredient is unsatisfactory. using an ingredient that is found un- (6) At the conclusion of the 21-day satisfactory by any prescribed test. maintenance period, monolayers shall (a) Samples of each lot of ingredient be tested for: of animal origin which is not subjected (i) Cytopathogenic and/or to heat sterilization, used to prepare a hemadsorbing agents as prescribed in biological product shall be shown free § 113.46; and

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(ii) Extraneous viruses by the fluo- into final containers shall be des- rescent antibody technique as pre- ignated as a serial. Each serial shall be scribed in § 113.47. given a number which shall be used in (d) Each lot of porcine trypsin which records, test reports, and on the final has not been treated to inactivate por- container label. cine parvovirus (PPV) in a manner ac- (c) Final container samples from ceptable to VS shall be tested for PPV each serial shall be tested for bacteria as prescribed in this paragraph. and fungi in accordance with the test (1) Not less than 5.0 grams of trypsin provided in § 113.26. Any serial found to shall be dissolved in a volume of suit- be unsatisfactory shall not be released. able diluent sufficient to fill a cen- [39 FR 27428, July 29, 1974, as amended at 56 trifuge angle head. After centrifuging FR 66784, Dec. 26, 1991] for 1 hour at 80,000×g, the pellet material shall be reconstituted in distilled § 113.55 Detection of extraneous water and inoculated into a flask con- agents in Master Seed Virus. taining 75 cm2 of a 30 to 50 percent con- Unless otherwise prescribed in a fluent monolayer culture of primary Standard Requirement or in a filed porcine cells or a porcine cell line of Outline of Production, each Master proven equal PPV susceptibility. An Seed Virus (MSV) shall be tested as additional flask of cells shall be held as prescribed in this section. A MSV a negative control. found unsatisfactory by any prescribed (2) The test and control monolayers test shall not be used. A serial of bio- shall be maintained for at least 14 days logical product shall not be released if and subcultured at least once during produced from a MSV that is found un- the maintenance period. satisfactory by any prescribed test. (3) At the end of the 14-day mainte- (a) At least a 1.0 ml aliquot per cell nance period, and 4 to 7 days after the culture of MSV shall be dispensed onto last subculturing, monolayers shall be monolayers (at least 75 cm2 in area) of: tested for the presence of porcine (1) Vero (African green monkey kid- parvovirus by the fluorescent antibody ney) cell line; technique as prescribed in § 113.47(c). (2) Embryonic cells, neonatal cells, (e) A sample of serum from each or a cell line of the species for which donor horse used to produce a lot of the vaccine is recommended; and equine serum used in the preparation (3) Embryonic cells, neonatal cells, of biological products recommended for or a cell line of the species of cells in use in horses shall be tested at a lab- which the MSV is presently being prop- oratory approved by Animal and Plant agated if different than prescribed in Health Inspection Service using the paragraphs (a)(1) and (a)(2) of this sec- Coggins test for equine infectious ane- tion. Cell lines used shall have been mia antibodies. If antibodies to equine found satisfactory when tested as pre- infectious anemia are found, the lot of scribed in § 113.52 and primary cells serum is unsatisfactory. used shall have been found satisfactory [50 FR 442, Jan. 4, 1985; 50 FR 3316, Jan. 24, when tested as prescribed in § 113.51. If 1985, as amended at 56 FR 66784, Dec. 26, 1991; the MSV is cytopathic for or causes 60 FR 24549, May 9, 1995] hemadsorption in the cells in which it is to be tested, the MSV shall be neu- § 113.54 Sterile diluent. tralized with monospecific antiserum Sterile Diluent shall be supplied in a supplied or approved by Animal and final container by the licensee when Plant Health Inspection Service such diluent is required for rehydration (APHIS) or counteracted by a method or dilution of the vaccine. approved by APHIS. (a) Sterile Diluent may be distilled (b) At least one monolayer of each or deionized water or it may be a spe- cell type used in the test shall be main- cial liquid solution formulated in ac- tained as an uninoculated control. cordance with an acceptable outline on (c) Each monolayer shall be main- file with Animal and Plant Health In- tained at least 14 days. spection Service. (d) Cells shall be subcultured at least (b) Each quantity prepared at one once during the maintenance period. time in a single container and bottled All but the last subculture shall result

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in at least one new monolayer at least lent of two doses of vaccine adminis- 75 cm2. The last subculture shall meet tered as recommended on the label. the minimum area requirement speci- (ii) Live bacterial vaccine rec- fied in §§ 113.46 and 113.47. ommended for use in cattle shall be (e) Monolayers shall be examined tested as provided in § 113.41, except regularly throughout the 14-day main- that calves shall be injected with the tenance period for evidence of equivalent of two doses of vaccine ad- cytopathogenic agents. If evidence of a ministered as recommended on the cytopathogenic agent is found, the label. MSV is unsatisfactory. (iii) Live bacterial vaccine rec- (f) At the conclusion of the 14-day ommended for use in sheep shall be maintenance period, monolayers shall tested as provided in § 113.45. be tested for: (iv) Live bacterial vaccine rec- (1) Cytopathogenic and/or ommended for use in swine shall be hemadsorbing agents as prescribed in tested as provided in § 113.44. § 113.46; (c) Identity test. At least one of the (2) Extraneous agents by the fluores- identity tests provided in this para- cent antibody technique as prescribed graph shall be conducted for the Mas- in § 113.47. ter Seed Bacteria and final container [50 FR 444, Jan. 4, 1985, as amended at 56 FR samples from each serial or first sub- 66784, Dec. 26, 1991] serial of completed biological product. A known positive control (reference) LIVE BACTERIAL VACCINES provided or approved by Animal and § 113.64 General requirements for live Plant Health Inspection Service shall bacterial vaccines. be included in such tests. When prescribed in an applicable (1) Fluorescent antibody test. The di- Standard Requirement or in the filed rect fluorescent antibody staining Outline of Production, a live bacterial technique shall be conducted using vaccine shall meet the requirements in suitable smears of the vaccine bac- this section. teria. Fluorescence typical for the bac- (a) Purity test. Final container sam- teria concerned shall be demonstrated. ples of completed product from each se- Fluorescence shall not occur in control rial and subserial, and samples of each smears treated with specific antiserum. lot of Master Seed Bacteria shall be (2) Tube agglutination test. A tube ag- tested for the presence of extraneous glutination test shall be conducted viable bacteria and fungi in accordance with a suitable suspension of the vac- with the test provided in § 113.27(b). cine bacteria using the constant anti- (b) Safety tests. (1) Samples of com- gen decreasing serum method with spe- pleted product from each serial or first cific antiserum. Agglutination typical subserial and samples of each lot of for the bacteria shall be demonstrated. Master Seed Bacteria shall be tested Agglutination shall not occur with for safety in young adult mice in ac- negative serum used as a control in cordance with the test provided in this test. § 113.33(b) unless: (3) Slide agglutination test. The rapid (i) The bacteria or agents in the vac- plate (slide) agglutination test shall be cine are inherently lethal for mice. conducted with suitable suspensions of (ii) The vaccine is recommended for the vaccine bacteria using the hanging poultry. drop, slide or plate method, with spe- (2) Samples of completed product cific antiserum. Agglutination typical from each serial or first subserial of for the bacteria shall be demonstrated live bacterial vaccine shall be tested by microscopic or macroscopic obser- for safety in one of the species for vation. Agglutination shall not occur which the product is recommended as with negative serum used as a control follows: in this test. (i) Live bacterial vaccine rec- (4) Characterization tests. Applicable ommended for use in dogs shall be test- biochemical and cultural characteris- ed as provided in § 113.40, except that tics shall be demonstrated as specified dogs shall be injected with the equiva- in the filed Outline of Production.

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(d) Ingredient requirements. Ingredi- organisms is evident, the serial or sub- ents used for the growth and prepara- serial is unsatisfactory. tion of Master Seed Bacteria and of (3) Bacterial dissociation test. Final live bacterial vaccine shall meet the container samples of completed prod- requirements provided in § 113.50. Ingre- uct from each serial and subserial shall dients of animal origin shall meet the be tested for bacterial dissociation. applicable requirements provided in Smooth colonies are the desired form. § 113.53. Rough colonies are undesirable ter- (e) Moisture content. The maximum minal dissociation forms. Intermediate percent moisture in desiccated vac- and intermediate-to-rough are also un- cines shall be stated in the filed Out- desirable. line of Production and shall be estab- (i) The sample container shall be re- lished by the licensee as follows: hydrated and streaked on one potato (1) Prelicensing. Data obtained by con- agar plate in such a manner as to ducting accelerated stability tests and produce confluent colonies. Artificial bacterial counts shall be acceptable on reflected light shall be used so that the a temporary basis. rays pass through the plate at a 45 (2) Licensed products. Data shall be °angle. obtained by determining the percent (ii) If the vaccine contains more than moisture and bacterial count at release 5 percent rough colonies or more than and expiration on a minimum of 10 con- 15 percent total undesirable colonies, secutive released serials. the serial or subserial is unsatisfac- (3) Final container samples of com- tory. If organisms or growth not char- pleted product from each serial and acteristic of Brucella abortus are found, subserial must be tested for moisture the serial or subserial is unsatisfac- content in accordance with the test tory. The test may be repeated one provided in § 113.29. time using double the number of sam- [48 FR 33476, July 22, 1983, as amended at 54 ples: Provided, That, if the test is not FR 19352, May 5, 1989; 56 FR 66784, Dec. 26, repeated, the serial or subserial is un- 1991; 68 FR 57608, Oct. 6, 2003] satisfactory. (b) Bacterial count requirements for re- § 113.65 Brucella Abortus Vaccine. duced dose vaccine. Each serial and each Brucella Abortus Vaccine shall be subserial shall be tested for potency. prepared as a desiccated live culture (1) Two final container vials of com- bacterial vaccine from smooth colonial pleted product shall be tested for the forms of the Brucella abortus organism, number of viable organisms per dose of identified as Strain 19. Each serial and rehydrated vaccine. A bacterial count subserial shall be tested for purity, po- per vial shall be made on tryptose agar tency, and moisture content. A serial plates from suitable dilutions using 1 or subserial found unsatisfactory by a percent peptone as a diluent. The in- prescribed test shall not be released. oculated media shall be incubated at 35 (a) Purity tests. Each serial and sub- to 37 °C for 96 hours. serial shall be tested for purity as pro- (2) If the average count of the two vided in this paragraph. final container samples of freshly pre- (1) Macroscopic and microscopic ex- pared vaccine contains less than 3.0 or amination shall be made on bulk sam- more than 10.0 billion organisms per ples from production containers. If or- dose, the serial or subserial is unsatis- ganisms not typical of Brucella abortus factory. organisms are evident, the serial or (3) If the average count on the initial subserial is unsatisfactory. test is less than the minimum or great- (2) Two final container vials of com- er than the maximum required in para- pleted product shall be tested by graph (b)(2) of this section, the serial inoculating one tube of Dextrose or subserial may be retested one time Andrades broth with gas tube and one using four additional final container tube of thioglycollate broth from each vials. The average count of the retest vial. The inoculated media shall be in- is determined. If the average count of cubated at 35 to 37 °C for 96 hours. If the four vials retested is less than the growth not typical of Brucella abortus required minimum or greater than the

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required maximum, the serial or sub- milliliter, the serial or subserial is un- serial is unsatisfactory. If the average satisfactory. count of the four vials retested is with- [39 FR 16857, May 10, 1974. Redesignated at 39 in the required limits described in FR 25463, July 11, 1974, and amended at 40 FR paragraph (b)(2) of this section, the fol- 758, Jan. 3, 1975; 50 FR 23794, Jan. 6, 1985] lowing shall apply: (i) If the average count obtained in § 113.66 Anthrax Spore Vaccine—Non- the initial test is less than one-third or encapsulated. more than three times the average Anthrax Spore Vaccine—Nonencap- count obtained on the retest, the aver- sulated shall be a live spore suspension age count of the initial test shall be prepared from nonencapsulated considered the result of test system variants of Bacillus anthracis. Only error and the serial or subserial is sat- Master Seed which has been estab- isfactory. lished as pure, safe, and immunogenic (ii) If the average count obtained in shall be used for production. All serials the initial test is one-third or more of vaccine shall be prepared from the than the average retest count or three first through the fifth passage from the times or less than the average retest Master Seed. count, a new average count shall be de- (a) The Master Seed shall meet the termined from the counts of all six applicable general requirements pre- vials. If the new average is less than scribed in § 113.64 and the requirements the minimum or greater than the max- in this section. imum required in paragraph (b)(2) of (b) Each lot of Master Seed shall be this section, the serial or subserial is tested for immunogenicity as follows: unsatisfactory. (1) Forty-two susceptible guinea pigs (4) If tested at any time within the from the same source each weighing 400 expiration period, each dose of re- to 500 grams, shall be used as test ani- hydrated vaccine must contain at least mals (30 vaccinates and 12 controls). 3.0 billion viable organisms per dose. (2) An arithmetic mean spore count (c) Bacterial count requirements for of vaccine produced from the highest standard vaccine. Each serial and sub- passage of the Master Seed shall be es- serial shall be tested for potency. tablished before the immunogenicity (1) Two final container samples shall test is conducted. The guinea pigs used be tested for the number of viable orga- as vaccinates shall be injected as rec- nisms per milliliter of rehydrated vac- ommended on the label with a pre- cine. One bacterial count per vial shall determined number of vaccine spores. be made on tryptose agar plates from To confirm the dosage, five replicate suitable dilutions using 1 percent pep- spore counts shall be conducted on a tone as a diluent. The inoculated media sample of the vaccine dilution used. shall be incubated at 35 to 37 °C for 96 (3) Fourteen to fifteen days hours. postvaccination the vaccinates and (2) If the average count of the two controls shall each be challenged with final container samples of freshly pre- not less than 4,500 guinea pig LD50 of a pared vaccine does not contain at least virulent suspension of Bacillus 10 billion viable organisms per milli- anthracis furnished or approved by Ani- liter, the serial or subserial is unsatis- mal and Plant Health Inspection Serv- factory. ice and observed for 10 days. (3) If the initial bacterial count is (4) If at least 10 of the 12 controls do less than 10 billion organisms per milli- not die from Bacillus anthracis within liter, the serial or subserial may be re- the 10-day postchallenge observation tested one time using four samples. If period the test is invalid and may be the average count of the four vials re- repeated. tested is less than the required min- (5) If at least 27 of 30 of the vac- imum, the serial or subserial is unsat- cinates do not survive the 10-day isfactory. postchallenge observation period, the (4) If tested at any time within the Master Seed is unsatisfactory. expiration period, each milliliter of re- (6) An Outline of Production change hydrated vaccine does not contain at shall be made before authority for use least 5 billion viable organisms per of a new lot of Master Seed shall be

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granted by Animal and Plant Health (1) Thirty Erysipelothrix rhusiopathiae Inspection Service. susceptible swine shall be used as test (c) Test Requirements for Release. Each animals (20 vaccinates and 10 controls) serial and subserial shall meet the ap- for each route of administration rec- plicable general requirements pre- ommended on the label. scribed in 9 CFR 113.64 and the require- (2) An arithmetic mean count of the ments in this paragraph. Any serial or colony forming units from vaccine pro- subserial found unsatisfactory by a duced from the highest passage of the prescribed test shall not be released. Master Seed shall be established before (1) Safety test. Samples of completed the immunogenicity test is conducted. product from each serial or first sub- The 20 swine to be used as vaccinates serial shall be tested for safety in sheep shall be injected as recommended on or goats by the methods described in 9 the label with a predetermined quan- CFR 113.45(a). tity of vaccine bacteria. The 10 control (2) Spore Count Requirements. Final swine shall be held separately from the container samples of completed prod- vaccinates. To confirm the dosage cal- uct shall be tested for spore count. culation, an arithmetic mean count Samples shall be diluted in tenfold shall be established by conducting five steps. Each dilution expected to yield replicate titrations on a sample of the 30 to 300 colonies per plate shall be bacterial vaccine dilution used. Only plated in triplicate on tryptose agar, plates containing between 30 and 300 inverted, and incubated at 35 to 70 °C colonies shall be considered in a valid for 24 hours to 28 hours. Each plate test. having uniformly distributed colonies shall be counted and an average count (3) The vaccinates and controls shall determined. To be eligible for release, be examined and their average body each serial and each subserial shall temperature determined prior to chal- have a spore count sufficiently greater lenge. Fourteen to twenty-one days than that of the vaccine used in the postvaccination, the vaccinates and immunogenicity test to assure that controls shall be challenged with a vir- when tested at any time within the ex- ulent Erysipelothrix rhusiopathiae cul- piration period, each serial and sub- ture and observed for 7 days. The chal- serial shall have a spore count of at lenge culture and instructions for prep- least twice that used in the aration and use shall be obtained from immunogenicity test but not less than Animal and Plant Health Inspection 2,000,000 spores per dose. Service. (4) A satisfactory challenge shall be [50 FR 23794, June 6, 1985, as amended at 56 evidenced in the controls by a high FR 66784, Dec. 26, 1991; 72 FR 72564, Dec. 21, 2007] body temperature or clinical signs including, but not limited to acute ill- § 113.67 Erysipelothrix Rhusiopathiae ness with hyperemia of the abdomen Vaccine. and ears, possibly terminating in sud- Erysipelothrix Rhusiopathiae Vac- den death; moribundity, with or with- cine shall be prepared as a desiccated out metastatic skin lesions; depression live culture of an avirulent or modified with anorexia, stiffness, and/or joint strain of Erysipelothrix rhusiopathiae. involvement; or any combination of Only Master Seed which has been es- these symptoms and lesions. tablished as pure, safe, and (5) If at least 80 percent of the con- immunogenic shall be used for vaccine trols do not show characteristic signs production. during the observation period includ- (a) The Master Seed shall meet the ing, but not limited to a body tempera- applicable requirements prescribed in ture of 105.6 °F or higher on at least 2 § 113.64 and the requirements in this consecutive days, the test shall be con- section. sidered inconclusive: Provided, That (b) Each lot of Master Seed used for control pigs which meet the criteria re- vaccine production shall be tested for quirements for susceptibility except immunogenicity. The selected bac- for high body temperature shall be con- terial count from the lot of Master sidered susceptible if sacrificed and or- Seed shall be established as follows: ganisms identified as Erysipelothrix

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rhusiopathiae can be isolated from the been established as pure, safe, and blood, spleen, or other organs. immunogenic shall be used for vaccine (6) To demonstrate immunity after production. All serials of vaccine shall challenge, the vaccinates shall remain be prepared from the first through the free of clinical signs and the body tem- fifth passage from the Master Seed. perature shall not exceed 104.6 °F on 2 (a) The Master Seed shall meet the or more consecutive days. If at least 90 applicable general requirements pre- percent of the vaccinates do not re- scribed in § 113.64 and the requirements main free from clinical signs and high in this section. body temperature throughout the ob- (b) Each lot of Master Seed used for servation period, the Master Seed is vaccine production shall be tested for unsatisfactory. immunogenicity. The immunogenicity (7) An Outline of Production change of a selected bacterial count from the shall be made before authority for use lot of Master Seed shall be established of a new Master Seed shall be granted as follows: by Animal and Plant Health Inspection (1) Fifteen Pasteurella haemolytica Service. susceptible calves shall be used as test (c) Test requirements for release. Each animals (10 vaccinates and 5 controls) serial and subserial shall meet the ap- for each route of administration rec- plicable requirements in § 113.64 and the ommended on the label. requirements in this paragraph. Any (2) An arithmetic mean count of the serial or subserial found unsatisfactory colony forming units from vaccine pro- by a prescribed test shall not be reduced from the highest passage of the leased. Master Seed shall be established before (1) Safety test. Samples of completed the immunogenicity test is conducted. product from each serial or first sub- The 10 calves to be used as vaccinates serial shall be tested for safety in shall be injected as recommended on young adult mice as prescribed in the label with a predetermined quan- § 113.33(b) and in swine as prescribed in tity of vaccine bacteria. The five con- § 113.44. trol calves shall be held separately (2) Bacterial count requirements. Final from the vaccinates. To confirm the container samples of completed prod- dosage calculation, five replicate titra- uct from each serial and each subserial tions on a sample of the bacterial vac- shall be tested for bacterial count cine used. Only plates containing be- using the method used in paragraph tween 30 and 300 colonies shall be con- (b)(2) of this section. Two replicate ti- sidered a valid test. trations shall be conducted on each (3) The vaccinates and controls shall sample. To be eligible for release, each be examined and their average body serial and subserial shall have a bac- temperature determined prior to chal- terial count sufficiently greater than lenge. Fourteen to twenty-one days that of the vaccine used in the post vaccination, the vaccinates and immunogenicity test to assure that, controls shall each be challenged by when tested at any time within the ex- the respiratory route with a (virulent) piration period, each serial and sub- pneumonia producing Pasteurella serial shall have a bacterial count two haemolytica culture and observed for 4 times greater than that used in such to 7 days. The challenge culture and in- immunogenicity test. structions for preparation for use shall [50 FR 23795, June 6, 1985, as amended at 56 be furnished or approved by the Animal FR 66784, Dec. 26, 1991; 72 FR 72564, Dec. 21, and Plant Health Inspection Service. 2007] (4) A satisfactory challenge shall be evidenced in the controls by progres- § 113.68 Pasteurella Haemolytica Vac- sion of clinical signs consistent with cine, Bovine. respiratory system infection following Pasteurella Haemolytica Vaccine, challenge, including but not limited to Bovine, shall be prepared as a des- lacrimation, mucoid nasal exudates, iccated live culture bacterial vaccine expiratory dyspnea, tachypnea, pul- of an avirulent or modified strain of monary rales, and cough possibly ter- Pasteurella haemolytica, identified as minating in death; moribundity, de- serotype 1. Only Master Seed which has pression with anorexia, diarrhea with

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substantial weight loss; or any com- § 113.69 Pasteurella Multocida Vac- bination of these symptoms. cine, Bovine. (5) Lung lesion response to challenge Pasteurella Multocida Vaccine, Bo- will be assessed in all calves. Lung le- vine, shall be prepared as a desiccated sions will be assessed at necropsy in live culture bacterial vaccine of an calves that succumb to challenge. Sur- avirulent or modified strain of viving calves will be euthanized on day Pasteurella multocida, of bovine origin. 4 to 7 following challenge and lung le- Only Master Seed which has been es- sions assessed at necropsy. Lung lesion tablished as pure, safe, and scores will be used in the assessment of immunogenic shall be used for vaccine the response to challenge exposure. If a production. All serials of vaccine shall significant difference in lung lesion be prepared from the first through the scores cannot be demonstrated between fifth passage from the Master Seed. vaccinates and controls using a scoring (a) The Master Seed shall meet the system approved by the Animal and applicable general requirements pre- Plant Health Inspection Service, the scribed in § 113.64 and the requirements Master Seed is unsatisfactory. in this section. (6) An Outline of Production change (b) Each lot of Master Seed used for must be made before authority for use vaccine production shall be tested for of a new lot of Master Seed is granted immunogenicity. The immunogenicity by the Animal and Plant Health In- of a selected bacterial count from the spection Service. lot of Master Seed shall be established (c) Test requirements for release. Each as follows: serial and subserial shall meet the ap- (1) Fifteen Pasteurella multocida sus- plicable general requirements pre- ceptible calves shall be used as test scribed in §§ 113.8 and 113.64 and the re- animals (10 vaccinates and 5 controls) quirements in this paragraph. Any se- for each route of administration rec- rial or subserial found unsatisfactory ommended on the label. by a prescribed test shall not be re- (2) An arithmetic mean count of the leased. colony forming units from vaccine pro- (1) Safety test. Samples of completed duced from the highest passage of the product from each serial or first sub- Master Seed shall be established before serial shall be tested for safety in the immunogenicity test is conducted. calves as provided in §§ 113.41(a) and The 10 calves to be used as vaccinates 113.41(b) except, that the equivalent of shall be injected as recommended on two doses of vaccine shall be used and the label with a predetermined quan- administered in the manner rec- tity of vaccine bacteria. The five con- ommended on the label. trol calves shall be held separately (2) Bacterial count requirements. Final from the vaccinates. To confirm the container samples of completed prod- dosage calculation, arithmetic mean uct shall be tested for bacterial count count shall be established by con- using the method used in paragraph ducting five replicate titrations on a (b)(2) of this section. Two replicate ti- sample of the bacterial vaccine used. trations shall be conducted on each se- Only plates containing between 30 and rial and subserial. Each sample shall be 300 colonies shall be considered a valid rehydrated with accompanying sterile test. diluent to the volume indicated on the (3) The vaccinates and controls shall label. To be eligible for release, each be examined and their average body serial and subserial shall have a bac- temperature determined prior to chal- terial count sufficiently greater than lenge. Fourteen to twenty-one days that of the vaccine used in the post vaccination, the vaccinates and immunogenicity test to assure that, controls shall each be challenged by when tested at any time within the ex- the respiratory route with a (virulent) piration period, each serial and sub- pneumonia producing Pasteurella serial shall have a bacterial count at multocida culture and observed for 4 to least two times greater than that used 10 days. The challenge culture and in- in the immunogenicity test. structions for preparation for use shall [55 FR 35559, Aug. 31, 1990, as amended at 72 be furnished or approved by the Animal FR 72564, Dec. 21, 2007] and Plant Health Inspection Service.

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(4) A satisfactory challenge shall be label. To be eligible for release, each evidenced in the controls by progres- serial and subserial shall have a bac- sion of clinical signs consistent with terial count sufficiently greater than respiratory system infection following that of the vaccine used in the challenge, including but not limited to immunogenicity test count per dose es- acute illness with higher body tem- tablished to assure that, when tested perature and respiration rate, at any time within the expiration pe- lacrimation, mucoid nasal exudate, ex- riod, each serial and subserial shall piratory dyspnea, tachypnea, pul- have a bacterial count at least two monary rales, and cough, possibly ter- times greater than that used in the minating in death; moribundity, de- immunogenicity test. pression with anorexia; diarrhea with [55 FR 35560, Aug. 31, 1990, as amended at 72 substantial weight loss; or any com- FR 72564, Dec. 21, 2007] bination of these symptoms. (5) Lung lesion response to challenge § 113.70 Pasteurella Multocida Vac- will be assessed in all calves. Lung le- cine, Avian Isolate. sions will be assessed at necropsy in Pasteurella Multocida Vaccine, calves that succumb to challenge. Sur- Avian Isolate, shall be prepared as a viving calves will be euthanized on day desiccated live culture of an avirulent 4 to 10 following challenge and lung le- or modified strain of Pasteurella sions assessed at necropsy. Lung lesion multocida. Only Master Seed which has scores will be used in the assessment of been established as pure, safe, and the response to challenge exposure. If a immunogenic shall be used for vaccine significant difference in lung lesion production. scores cannot be demonstrated between (a) The Master Seed shall meet the vaccinates and controls using a scoring applicable general requirements pre- system approved by the Animal and scribed in § 113.64 and the requirements Plant Health Inspection Service, the in this section. Master Seed is unsatisfactory. (b) Each lot of Master Seed used for (6) An Outline of Production change vaccine production shall be tested for must be made before authority for use immunogenicity in each species and for of a new lot of Master Seed is granted each serotype for which the Master by the Animal and Plant Health In- Seed is claimed to give protection. spection Service. (1) Thirty Pasteurella multocida sus- (c) Test requirements for release. Each ceptible birds shall be used as test ani- serial and subserial shall meet the ap- mals (20 vaccinates and 10 controls) for plicable general requirements pre- each bird species, route of administra- scribed in §§ 113.8 and 113.64 and the re- tion, and serotype for which protection quirements in this paragraph. Any se- is claimed on the label. rial or subserial found unsatisfactory (2) An arithmetic mean count of col- by a prescribed test shall not be re- ony forming units from vaccine pro- leased. duced from the highest passage of Mas- (1) Safety Test. Samples of completed ter Seed shall be established before the product from each serial or first sub- immunogenicity test is conducted. The serial shall be tested for safety in 20 birds to be used as vaccinates shall calves as provided in §§ 113.41(a) and be inoculated, as recommended on the 113.41(b), except that the equivalent of label with a predetermined quantity of two doses of vaccine shall be used and vaccine bacteria. The 10 control birds administered in the manner rec- shall be held separately from the vac- ommended on the label. cinates. To confirm the dosage calcula- (2) Bacterial count requirements. Final tion, an arithmetic mean count shall container samples of completed prod- be established by conducting five rep- uct shall be tested for bacterial count licate titrations on a sample of the using the method used in paragraph bacterial vaccine used. Only plates (b)(2) of this section. Two replicate ti- containing between 30 and 300 colonies trations shall be conducted on each se- shall be considered in a valid test. rial and subserial. Each sample shall be (3) Not less than 14 days after vac- rehydrated with accompanying sterile cination, each of 20 vaccinates and diluent to the volume indicated on the each of 10 unvaccinated controls shall

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be challenged intramuscularly or by riod, each serial and subserial shall other methods acceptable to the Ani- have a bacterial count at least two mal and Plant Health Inspection Serv- times greater than that used in the ice with a virulent Pasteurella multocida immunogenicity test. strain, for which protection is claimed, [55 FR 35560, Aug. 31, 1990, as amended at 59 and observed daily for a 14 day post- FR 19633, Apr. 25, 1994; 64 FR 43044, Aug. 9, challenge period. 1999; 72 FR 72564, Dec. 21, 2007] (4) Eight or more of the unvaccinated controls must die for the test to be § 113.71 Chlamydia Psittaci Vaccine valid. If at least 16 of 20 of the vac- (Feline Pneumonitis), Live cinates do not survive the 14-day Chlamydia. postchallenge period, the Master Seed Chlamydia Psittaci Vaccine (Feline is unsatisfactory at the selected bac- Pneumonitis), Live Chlamydia, shall be terial count. prepared from chlamydia-bearing cell (c) Test requirements for release. Each culture fluids or embryonated chicken serial and subserial shall meet the ap- eggs. Only Master Seed which has been plicable requirements in §§ 113.8 and established as pure, safe, and 113.64 and the requirements in this immunogenic shall be used for vaccine paragraph. Any serial or subserial production. All serials of vaccine shall found unsatisfactory by a prescribed be prepared from the first through the test shall not be released. fifth passage from the Master Seed. (1) Safety test. Samples of completed (a) The Master Seed shall meet the product from each serial or first sub- applicable requirements prescribed in serial shall be tested for safety. § 113.300 and the requirements in this (i) Ten birds of a species for which section. Master Seed propagated in the vaccine is recommended shall be chicken embryos shall be tested for given the equivalent of 10 doses each of pathogens by the chicken embryo test the vaccine and observed for 10 days. If prescribed in § 113.37. If found unsatis- the vaccine is recommended for more factory by any prescribed test, the than one species, only one species Master Seed shall not be used. needs to be tested. (b) Each lot of Master Seed used for (ii) If unfavorable reactions attrib- vaccine production shall be tested for utable to the vaccine occur during the immunogenicity. The immunogenicity observation period in two or more of of a selected dose from the lot of Mas- the test birds, the serial is unsatisfac- ter Seed shall be established as follows: tory. (1) Thirty feline pneumonitis suscep- (iii) If unfavorable reactions occur tible cats shall be used as test animals which are not attributable to the test (20 vaccinates and 10 controls). Blood vaccine, the test is inconclusive and samples shall be drawn and individual may be repeated. If the results of the serum samples tested. The cats shall be next test are not satisfactory, or if the considered suitable for use if all serums test is not repeated, the serial shall be are negative for pneumonitis antibody considered unsatisfactory. in a complement fixation test or other (2) Bacterial count requirements. Final test of equal sensitivity. container samples of completed prod- (2) A geometric mean titer of the uct shall be tested for bacterial count dried vaccine produced from the high- using the method used in paragraph est passage of the Master Seed shall be (b)(2) of this section. Two replicate ti- established before the immunogenicity trations shall be conducted on each se- test is conducted. The 20 cats used as rial and subserial. Each sample shall be vaccinates shall be administered a pre- rehydrated with accompanying sterile determined quantity of vaccine by the diluent to the volume indicated on the method to be recommended on the label. To be eligible for release, each label and the remaining 10 cats shall be serial and subserial shall have a bac- held as controls. To confirm the dosage terial count sufficiently greater than calculations, five replicate titrations that of the vaccine used in the shall be conducted on a sample of the immunogenicity test count per dose es- vaccine dilution used. If two doses are tablished to assure that, when tested used, five replicate confirming titra- at any time within the expiration pe- tions shall be conducted on each dose.

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(3) Fourteen or more days after the immunogenicity test but not less than final dose of vaccine, the vaccinates 2.5 ID50 per dose. and controls shall each be challenged [55 FR 35561, Aug. 31, 1990, as amended at 56 intranasally with a minimum of 10,000 FR 66786, Dec. 26, 1991; 72 FR 72564, Dec. 21, yolk sac LD50 of virulent feline pneu- 2007] monitis furnished or approved by the Animal and Plant Health Inspection INACTIVATED BACTERIAL PRODUCTS Service and observed each day for 28 § 113.100 General requirements for in- days postchallenge. The rectal tem- activated bacterial products. perature of each animal shall be taken and the presence or absence of clinical Unless otherwise prescribed in an applicable Standard Requirement or in signs noted and recorded each day. the filed Outline of Production, an in- (i) If less than 8 of 10 controls show activated bacterial product shall meet clinical signs of feline pneumonitis in- the applicable requirements in this sec- fection other than fever, the test is in- tion. conclusive and may be repeated. (a) Purity tests. (1) Final container (ii) If a significant difference in clin- samples of completed product from ical signs other than fever or each serial and each subserial shall be chlamydia shedding cannot be dem- tested for viable bacteria and fungi as onstrated between vaccinates and con- provided in § 113.26. trols using a scoring system approved (2) Each lot of Master Seed Bacteria by the Animal and Plant Health In- shall be tested for the presence of ex- spection Service, the Master Seed is traneous viable bacteria and fungi in unsatisfactory. accordance with the test provided in (4) An Outline of Production change § 113.27(d). must be made before authority for use (b) Safety tests. Bulk or final con- of a new lot of Master Seed is granted tainer samples of completed product by the Animal and Plant Health In- from each serial shall be tested for spection Service. safety in young adult mice in accordance with the test provided in (c) Test requirements for release: Ex- § 113.33(b) unless: cept for § 113.300(a)(3)(ii), each serial (1) The product contains material and subserial shall meet the require- which is inherently lethal for mice. In ments prescribed in § 113.300 and in this such instances, the guinea pig safety paragraph. Final container samples of test provided in § 113.38 shall be con- completed product shall be tested. Any ducted in place of the mouse safety serial or subserial found unsatisfactory test. by a prescribed test shall not be re- (2) The product is recommended for leased. poultry. In such instances, the product (1) The test for pathogens prescribed shall be safety tested in poultry as de- in § 113.37 shall be conducted on each fined in the specific Standard Require- serial or one subserial of avian origin ment or Outline of Production for the vaccine. product. (2) Chlamydia titer requirements. Final (3) The product is recommended for container samples of completed prod- fish, other aquatic species, or reptiles. uct shall be tested for chlamydia titer In such instances, the product shall be using the titration method used in safety tested in fish, other aquatic spe- paragraph (b)(2) of this section. To be cies, or reptiles as required by specific eligible for release, each serial and Standard Requirement or Outline of each subserial shall have a titer suffi- Production for the product. ciently greater than the titer of vac- (c) Identity test. Methods of identification of Master Seed Bacteria to the cine used in the immunogenicity test genus and species level by laboratory prescribed in paragraph (b) of this sec- tests shall be sufficient to distinguish tion to assure that when tested at any the bacteria from other similar bac- time within the expiration period, each teria according to criteria described in serial and subserial shall have a titer the most recent edition of ‘‘Bergey’s 0.7 greater than that used in such Manual of Systematic Bacteriology’’ or

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the American Society for Microbiology taining clostridial antigens, must not ‘‘Manual of Clinical Microbiology’’. If exceed 0.74 grams per liter (g/L). Master Seed Bacteria are referred to by serotype, serovar, subtype, pilus type, [39 FR 16862, May 10, 1974. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 60 FR strain or other taxonomic subdivision 14355, Mar. 17, 1995; 68 FR 35283, June 13, 2003] below the species level, adequate testing must be used to identify the bac- § 113.101 Leptospira Pomona Bacterin. teria to that level. Tests which may be used to identify Master Seed Bacteria Leptospira Pomona Bacterin shall be include, but are not limited to: produced from a culture of Leptospira (1) Cultural characteristics, pomona which has been inactivated and (2) Staining reaction, is nontoxic. Each serial of biological (3) Biochemical reactivity, product containing Leptospira pomona (4) Fluorescent antibody tests, fraction shall meet the applicable re- (5) Serologic tests, quirements in § 113.100 and shall be (6) Toxin typing, tested for purity, safety, and potency (7) Somatic or flagellar antigen char- as prescribed in this section. A serial acterization, and found unsatisfactory by any prescribed (8) Restriction endonuclease analysis. test shall not be released. (d) Ingredient requirements. Ingredi- (a) Purity test. Final container sam- ents used for the growth and prepara- ples of completed product from each se- tion of Master Seed Bacteria and of rial and each subserial shall be tested final product shall meet the require- for viable bacteria and fungi as pro- ments provided in § 113.50. Ingredients vided in § 113.26. of animal origin shall meet the appli- (b) Safety test. Bulk or final container cable requirements provided in § 113.53. samples of completed product from (e) Only serials tested for viricidal each serial shall be tested for safety as activity in accordance with the test provided in § 113.38. provided in § 113.35 and found satisfactory by such test shall be packaged as (c) Potency test. Bulk or final con- diluent for desiccated fractions in com- tainer samples of completed product bination packages. shall be diluted with physiological sa- (f) If formaldehyde is used as the in- line so that each 0.25 ml contains not activating agent, and the serial has not more than 1/800th of the dose rec- been found satisfactory by the viricidal ommended on the label and shall be activity test, bulk or final container tested for potency, using the two-stage samples of completed product from test provided in this paragraph. each serial must be tested for residual (1) Vaccinates. Inject each of at least free formaldehyde content using the 10 but not more than 12 young adult ferric chloride test. 2 Firms currently hamsters, each weighing 50 to 90 using tests for residual free formalde- grams, with 0.25 ml of the diluted hyde content other than the ferric bacterin either subcutaneously or chloride test have until July 14, 2004 to intramuscularly, in accordance with update their Outline of Production to the label recommendations for use. be in compliance with this require- (2) Controls. Retain at least 10 but not ment. more than 12 additional hamsters from (1) The residual free formaldehyde the same group as unvaccinated con- content of biological products controls. taining clostridial antigens must not (3) Challenge. From 14 to 18 days exceed 1.85 grams per liter (g/L). (2) The residual free formaldehyde postvaccination, challenge each of 10 content of bacterins, bacterin-toxoids, vaccinates and each of 10 controls and toxoids, other than those con- intraperitoneally with a suspension of virulent Leptospira pomona organisms, using a dose of 10–10,000 hamster LD50 2 The procedures for performing the ferric as determined by titration. chloride test for residual free formaldehyde may be obtained from USDA, APHIS, Center (4) Post-challenge period. Observe the for Veterinary Biologics-Laboratory, 1800 vaccinates and controls for 14 days Dayton Road, P.O. Box 844, Ames, IA 50010. post-challenge and record all deaths. If

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eight or more controls die of lepto- grams, with 0.25 ml of the diluted spirosis, the test is valid and the re- bacterin either subcutaneously or sults shall be evaluated according to intramuscularly, in accordance with the following table: the label recommendations for use. (2) Controls. Retain at least 10 but not Cumu- Cumulative Cumulative Number lative total dead total dead more than 12 additional hamsters from Stage of vac- number hamsters for hamsters for the same group as unvaccinated con- cinates of vac- satisfactory unsatisfactory cinates serial serial trols. (3) Challenge. From 14 to 18 days 1 ...... 10 ...... 10 ...... 2 or less ..... 5 or more. 2 ...... 10 ...... 20 ...... 5 or less ..... 6 or more. postvaccination, challenge each of 10 vaccinates and each of 10 controls (5) If three or four vaccinates die in intraperitoneally with a suspension of the first stage, the second stage shall virulent Leptospira icterohaemorrhagiae be conducted in a manner identical to organisms, using a dose of 10–10,000 the first stage. hamster LD50 as determined by titra- (6) If the second stage is used, each tion. serial shall be evaluated according to (4) Post-challenge period. Observe the the second part of the table. On the vaccinates and controls for 14 days basis of cumulative results, each serial post-challenge and record all deaths. If shall either pass or fail. eight or more controls die from leptospirosis, the test is valid and the re- [39 FR 16862, May 10, 1974, as amended at 40 FR 20067, May 8, 1975; 45 FR 40100, June 13, sults shall be evaluated according to 1980. Redesignated at 55 FR 35562, Aug. 31, the following table: 1990, as amended at 56 FR 66785, Dec. 26, 1991] Cumu- Cumulative Cumulative Number lative total dead total dead § 113.102 Leptospira Stage of vac- number hamsters for hamsters for Icterohaemorrhagiae Bacterin. cinates of vac- satisfactory unsatisfactory cinates serial serial Leptospira Icterohaemorrhagiae Bacterin shall be produced from a cul- 1 ...... 10 ...... 10 ...... 2 or less ..... 5 or more. ture of Leptospira icterohaemorrhagiae 2 ...... 10 ...... 20 ...... 5 or less ..... 6 or more. which has been inactivated and is nontoxic. Each serial of biological (5) If three or four vaccinates die in product containing Leptospira the first stage, the second stage shall icterohaemorrhagiae fraction shall meet be used. The second stage shall be con- the applicable requirements in § 113.100 ducted in a manner identical to the and be tested for purity, safety, and po- first stage. tency as prescribed in this section. A (6) If the second stage is used, each serial found unsatisfactory by any pre- serial shall be evaluated according to scribed test shall not be released. the second part of the table. On the (a) Purity test. Final container sam- basis of cumulative results, each serial ples of completed product from each se- shall either pass or fail. rial and each subserial shall be tested [39 FR 16862, May 10, 1974, as amended at 45 for viable bacteria and fungi as pro- FR 40100, June 13, 1980. Redesignated at 55 vided in § 113.26. FR 35562, Aug. 31, 1990, as amended at 56 FR (b) Safety test. Bulk or final container 66785, Dec. 26, 1991] samples of completed product from each serial shall be tested for safety as § 113.103 Leptospira Canicola provided in § 113.38. Bacterin. (c) Potency test. Bulk or final con- Leptospira Canicola Bacterin shall be tainer samples of completed product produced from a culture of Leptospira shall be diluted with physiological sa- canicola which has been inactivated line so that each 0.25 ml contains not and is nontoxic. Each serial of biologi- more than 1/80th of the dose rec- cal product containing Leptospira canic- ommended on the label and shall be ola fraction shall meet the applicable tested for potency, using the two-stage requirements in § 113.100 and shall be test provided in this paragraph. tested for purity, safety, and potency (1) Vaccinates. Inject each of at least as prescribed in this section. Serials 10 but not more than 12 young adult found unsatisfactory by any prescribed hamsters, each weighing 50 to 90 test shall not be released.

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(a) Purity test. Final container sam- basis of cumulative results, each serial ples of completed product from each se- shall either pass or fail. rial and each subserial shall be tested [39 FR 16862, May 10, 1974, as amended at 45 for viable bacteria and fungi as pro- FR 40100, June 13, 1980. Redesignated at 55 vided in § 113.26. FR 35562, Aug. 31, 1990, as amended at 56 FR (b) Safety test. Bulk or final container 66785, Dec. 26, 1991] samples of completed product from each serial shall be tested for safety as § 113.104 Leptospira Grippotyphosa provided in § 113.38. Bacterin. (c) Potency test. Bulk or final con- Leptospira Grippotyphosa Bacterin tainer samples of completed product shall be produced from a culture of shall be diluted with physiological sa- Leptospira grippotyphosa which has been line so that each 0.25 ml contains not inactivated and is nontoxic. Each se- more than 1/80th of the dose rec- rial of biological product containing ommended on the label and shall be Leptospira grippotyphosa fraction shall tested for potency, using the two-stage meet the applicable requirements in test provided in this paragraph. § 113.100 and shall be tested for purity, safety, and potency as prescribed in (1) Vaccinates. Inject each of at least this section. A serial found unsatisfac- 10 but not more than 12 young adult tory by any prescribed test shall not be hamsters, each weighing 50 to 90 released. grams, with 0.25 ml of the diluted (a) Purity test. Final container sam- bacterin either subcutaneously or ples of completed product from each se- intramuscularly, in accordance with rial and each subserial shall be tested the label recommendations for use. for viable bacteria and fungi as pro- (2) Controls. Retain at least 10 but not vided in § 113.26. more than 12 additional hamsters from (b) Safety test. Bulk or final container the same group as unvaccinated con- samples of completed product from trols. each serial shall be tested for safety as (3) Challenge. From 14 to 18 days provided in § 113.38. postvaccination, challenge each of 10 (c) Potency test. Bulk or final con- vaccinates and each of 10 controls tainer samples of completed product intraperitoneally with a suspension of shall be diluted with physiological sa- virulent Leptospira canicola organisms, line so that each 0.25 ml contains not using a dose of 10–10,000 hamster LD50 more than 1/800th of the dose rec- as determined by titration. ommended on the label and shall be (4) Post-challenge period. Observe the tested for potency, using the two-stage vaccinates and controls for 14 days test provided in this paragraph. post-challenge and record all deaths. If (1) Vaccinates. Inject each of at least eight or more controls die from lepto- 10 but not more than 12 young adult spirosis, test is valid and the results hamsters, each weighing 50 to 90 shall be evaluated according to the fol- grams, with 0.25 ml of the diluted lowing table: bacterin either subcutaneously or intramuscularly, in accordance with Cumu- Cumulative Cumulative the label recommendations for use. Number lative total dead total dead Stage of vac- number hamsters for hamsters for (2) Controls. Retain at least 10 but not cinates of vac- satisfactory unsatisfactory more than 12 additional hamsters from cinates serial serial the same group as unvaccinated con- 1 ...... 10 ...... 10 ...... 2 or less ..... 5 or more. trols. 2 ...... 10 ...... 20 ...... 5 or less ..... 6 or more. (3) Challenge. From 14 to 18 days postvaccination, challenge each of 10 (5) If three or four vaccinates die in vaccinates and each of 10 controls the first stage, the second stage shall intraperitoneally with a suspension of be used. The second stage shall be con- virulent Leptospira grippotyphosa orga- ducted in a manner identical to the nisms, using a dose of 10–10,000 hamster first stage. LD50 as determined by titration. (6) If the second stage is used, each (4) Post-challenge period. Observe the serial shall be evaluated according to vaccinates and controls for 14 days the second part of the table. On the post-challenge and record all deaths. If

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eight or more controls die of lepto- § 113.106 Clostridium Chauvoei spirosis, the test is valid and the re- Bacterin. sults shall be evaluated according to Clostridium Chauvoei Bacterin shall the following table: be produced from a culture of Clos- tridium chauvoei which has been inac- CUMULATIVE TOTALS tivated and is nontoxic. Each serial of biological product containing Clos- Number of Dead hamsters Dead hamsters Stage vaccinates for acceptance for rejection tridium chauvoei fraction shall meet the applicable requirements in § 113.100 and 1 ...... 10 ...... 2 or less ...... 5 or more. shall be tested for purity, safety, and 2 ...... 20 ...... 5 or less ...... 6 or more. potency as prescribed in this section. Serials found unsatisfactory by any (5) If three or four vaccinates die in prescribed test shall not be released. the first stage, the second stage shall (a) Purity test. Final container sam- be conducted in a manner identical to ples of completed product from each se- the first stage. rial and each subserial shall be tested (6) If the second stage is used, each for viable bacteria and fungi as pro- serial shall be evaluated according to vided in § 113.26. the second part of the table. On the (b) Safety test. Bulk or final container basis of cumulative results, each serial samples of completed product from shall either pass or fail. each serial shall be tested for safety as provided in § 113.38. [40 FR 17003, Apr. 16, 1975, as amended at 40 (c) Potency test. Bulk or final con- FR 23989, June 4, 1975; 45 FR 40100, June 13, tainer samples of completed product 1980. Redesignated at 55 FR 35562, Aug. 31, from each serial shall be tested for po- 1990, as amended at 56 FR 66785, Dec. 26, 1991] tency using the two-stage test provided § 113.105 Leptospira Hardjo Bacterin. in this paragraph. (1) Each of at least 8 but not more Leptospira Hardjo Bacterin shall be than 10 guinea pigs, each weighing 300 produced from a culture of Leptospira to 500 grams, shall be injected hardjo which has been inactivated and subcutaneously with a guinea pig dose. is nontoxic. Each serial of biological A second guinea pig dose shall be in- product containing Leptospira hardjo jected 21 to 23 days after the first dose. fraction shall meet the applicable re- Each guinea pig dose shall be one-fifth quirements in § 113.100 and shall be of the dose recommended on the label tested for purity, safety, and potency for a calf. as prescribed in this section. A serial (2) Clostridium chauvoei challenge ma- found unsatisfactory by any prescribed terial, available upon request from test shall not be released. Animal and Plant Health Inspection (a) Purity test. Final container sam- Service, shall be used for challenge 14 ples of completed product from each se- to 15 days following the last injection rial and each subserial shall be tested of the product. Each of eight vac- for viable bacteria and fungi as pro- cinates and each of five additional non- vaccinated guinea pigs for controls vided in § 113.26. shall be injected intramuscularly with (b) Safety test. Bulk or final container approximately 100 LD50 of challenge samples of completed product from material. This dose shall be determined each serial shall be tested for safety as by statistical analysis of results of ti- provided in § 113.38. trations of the challenge material. The (c) Potency test. Bulk or final con- vaccinates and controls shall be ob- tainer samples of completed product served for 3 days postchallenge and all from each serial shall be tested for po- deaths recorded. tency using the test written into the (3) For a valid test, at least 80 per- filed Outline of Production. cent of the controls shall die within the 3 day post-challenge observation [40 FR 17003, Apr. 16, 1975, as amended at 40 period. If this requirement is met, the FR 20067, May 8, 1975. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR results of the potency test shall be 66785, Dec. 26, 1991] evaluated according to the following table:

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Cumu- Cumulative Cumulative of the product. Each of eight vac- Number lative total number total number cinates and each of five additional non- Stage of vac- number of deaths for of deaths for cinates of vac- a satisfac- an unsatisfac- vaccinated guinea pigs for controls cinates tory test tory test shall be injected intramuscularly with 1 ...... 8 ...... 8 ...... 1 or less ..... 3 or more. approximately 100 LD50 of challenge 2 ...... 8 ...... 16 ...... 4 or less ..... 5 or more. material. This dose shall be determined by statistical analysis of results of ti- The second stage shall be required only trations of the challenge material. The when exactly two animals die in the vaccinates and controls shall be ob- first stage. The second stage shall be served for 3 days postchallenge and all conducted in a manner identical to the deaths recorded. first stage. (3) For a valid test, at least 80 per- [39 FR 16862, May 10, 1974, as amended at 45 cent of the controls shall die within FR 40100, June 13, 1980. Redesignated at 55 the 3 day post-challenge observation FR 35562, Aug. 31, 1990 and amended at 56 FR period. If this requirement is met, the 66784, 66785, Dec. 26, 1991] results of the potency test shall be evaluated according to the following § 113.107 Clostridium Haemolyticum table: Bacterin. Cumu- Cumulative Cumulative Clostridium Haemolyticum Bacterin Number lative total number total number shall be produced from a culture of Stage of vac- number of deaths for of deaths for cinates of vac- a satisfac- an unsatisfac- Clostridium haemolyticum which has cinates tory test tory test been inactivated and is nontoxic. Each serial of biological product containing 1 ...... 8 ...... 8 ...... 1 or less ..... 3 or more. Clostridium haemolyticum fraction shall 2 ...... 8 ...... 16 ...... 4 or less ..... 5 or more. meet the applicable requirements in § 113.100 and shall be tested for purity, The second stage shall be required only safety, and potency as prescribed in when exactly two animals die in the this section. A serial found unsatisfac- first stage. The second stage shall be tory by any prescribed test shall not be conducted in a manner identical to the released. first stage. (a) Purity test. Final container sam- [39 FR 16862, May 10, 1974, as amended at 40 ples of completed product from each se- FR 20067, May 8, 1975; 45 FR 40100, June 13, rial and each subserial shall be tested 1980. Redesignated at 55 FR 35562, Aug. 31, for viable bacteria and fungi as pro- 1990, as amended at 56 FR 66784, 66785, Dec. vided in § 113.26. 26, 1991] (b) Safety test. Bulk or final container samples of completed product from § 113.108 Clostridium Novyi Bacterin- each serial shall be tested for safety as Toxoid. provided in § 113.38. Clostridium Novyi Bacterin-Toxoid (c) Potency test. Bulk or final con- shall be produced from a culture of tainer samples of completed product Clostridium novyi which has been inac- from each serial shall be tested for po- tivated and is nontoxic. Each serial of tency using the two-stage test provided biological product containing Clos- in this paragraph. tridium novyi fraction shall meet the (1) Each of at least 8 but not more applicable requirements in § 113.100 and than 10 guinea pigs, each weighing 300 shall be tested for purity, safety, and to 500 grams, shall be injected potency as prescribed in this section. A subcutaneously with a guinea pig dose. serial found unsatisfactory by any pre- A second guinea pig dose shall be in- scribed test shall not be released. jected 21 to 23 days after the first dose. (a) Purity test. Final container sam- Each guinea pig dose shall be one-fifth ples of completed product from each se- of the dose recommended on the label rial and each subserial shall be tested for a calf. for viable bacteria and fungi as pro- (2) Clostridium haemolyticum challenge vided in § 113.26. material, available upon request from (b) Safety test. Bulk or final container Animal and Plant Health Inspection samples of completed product from Service, shall be used for challenge 14 each serial shall be tested for safety as to 15 days following the last injection provided in § 113.38.

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(c) Potency test. Bulk or final con- (i) At least seven rabbits are required tainer samples of completed product to make an acceptable serum pool. from each serial shall be tested for po- (ii) Equal quantities of serum from tency using the Alpha toxin-neutraliza- each rabbit shall be combined and test- tion test provided in this paragraph. ed as a single pooled serum. (1) When used in this test, the fol- (iii) If less than seven rabbits are lowing words and terms shall mean: available, the test is invalid and shall (i) International antitoxin unit. (I.U.) be repeated: Provided, That, if the test That quantity of Alpha Antitoxin is not repeated, the serial shall be de- which reacts with Lo and L+ doses of clared unsatisfactory. Standard Toxin according to their defi- (4) The antitoxin content of the rab- nitions. bit serums shall be determined by the (ii) Lo dose. The largest quantity of serum neutralization test as follows: toxin which can be mixed with one unit (i) Make a dilution of Standard Anti- of Standard Antitoxin and not cause toxin to contain 0.1 International Unit sickness or death in injected mice. of antitoxin per ml. (iii) L+ dose. The smallest quantity of (ii) Make a dilution of Standard toxin which can be mixed with one unit Toxin in which 0.1 Lo dose is contained of Standard Antitoxin and cause death in a volume of 1 ml or less. Make a sec- in at least 80 percent of injected mice. ond dilution of Standard Toxin in (iv) Standard antitoxin. The Alpha which 0.1 L+ dose is contained in a vol- Antitoxin preparation which has been ume of 1 ml or less. standardized as to antitoxin unitage on (iii) Combine 0.1 International Unit the basis of the International Clos- of Standard Antitoxin with 0.1 Lo dose tridium novyi Alpha Antitoxin Standard of diluted Standard Toxin and combine and which is either supplied by or ac- 0.1 International Unit of Standard ceptable to the Animal and Plant Antitoxin with 0.1 L+ dose of diluted Health Inspection Service. The anti- Standard Toxin. Each mixture is ad- toxin unit value shall be stated on the justed to a final volume of 2.0 ml with label. diluent. (v) Standard toxin. The Alpha toxin (iv) Combine 0.1 Lo dose of diluted preparation which is supplied by or is Standard Toxin with a 0.2 ml volume of acceptable to the Animal and Plant undiluted serum. The mixture is ad- Health Inspection Service. justed to a final volume of 2.0 ml with (vi) Diluent. The solution used to diluent. make proper dilutions prescribed in (v) Neutralize all toxin-antitoxin this test. Such solutions shall be made mixtures at room temperature for 1 by dissolving 1 gram of peptone and hour and hold in ice water until injec- 0.25 gram of sodium chloride in each 100 tions of mice can be made. ml of distilled water; adjusting the pH (vi) Five Swiss white mice, each to 7.2; autoclaving at 121 °C for 25 min- weighing 16–20 grams, shall be used for utes; and storing at 4 °C until used. each toxin-antitoxin mixture. A dose of (2) Each of at least eight rabbits of a 0.2 ml shall be injected intravenously strain acceptable to the Animal and into each mouse. Conclude the test 72 Plant Health Inspection Service, each hours post injection and record all weighing 4–8 pounds, shall be injected deaths. subcutaneously with not more than (5) Test Interpretation shall be as fol- half of the recommended cattle dose. lows: Provided, That, if the product is rec- (i) If any mice inoculated with the ommended only for sheep, half of the mixture of 0.1 International Unit of recommended sheep dose shall be used. Standard Antitoxin and 0.1 Lo doses of A second dose shall be given not less Standard Toxin die, the results of the than 20 days nor more than 23 days serum neutralization test are inconclu- after the first dose. sive and shall be repeated: Provided, (3) Fourteen to seventeen days after That, if the test is not repeated, the se- the second dose, all surviving rabbits rial shall be declared unsatisfactory. shall be bled, and the serum tested for (ii) If less than 80 percent of the mice antitoxin content. inoculated with the mixture of 0.1

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International Unit of Standard Anti- (iii) L+ dose. The smallest quantity of toxin and 0.1 L+ doses of Standard toxin which can be mixed with one unit Toxin die, the results of the serum neu- of Standard Antitoxin and cause death tralization test are inconclusive and in at least 80 percent of injected mice. shall be repeated: Provided, That, if the (iv) Standard antitoxin. The antitoxin test is not repeated, the serial shall be preparation which has been standard- declared unsatisfactory. ized as to antitoxin unitage on the (iii) If any mice inoculated with the basis of the International Clostridium mixture of 0.2 ml undiluted serum with sordellii Antitoxin Standard and which 0.1 Lo dose of Standard Toxin die, the is either supplied by or acceptable to serum is considered to contain less the Animal and Plant Health Inspec- than 0.50 International Units per ml. tion Service. The antitoxin unit value (iv) If the single pooled serum from shall be stated on the label. seven or more rabbits contains less (v) Standard toxin. The toxin prepara- than 0.5 International Unit per ml, the tion which is supplied by or is accept- serial is unsatisfactory. able to the Animal and Plant Health Inspection Service. [39 FR 16862, May 10, 1974, as amended at 45 FR 40101, June 13, 1980. Redesignated at 55 (vi) Diluent. The solution used to FR 35562, Aug. 31, 1990; 56 FR 37825, Aug. 9, make proper dilutions prescribed in 1991, as amended at 56 FR 66784, 66785, Dec. this test. Such solutions shall be made 26, 1991] by dissolving 1 gram of peptone and 0.25 gram of sodium chloride in each 100 § 113.109 Clostridium Sordellii ml of distilled water; adjusting the pH Bacterin-Toxoid. to 7.2; autoclaving at 121 °C for 25 min- Clostridium Sordellii Bacterin-Tox- utes; and storing at 4 °C until used. oid shall be produced from a culture of (2) Each of at least eight rabbits of a Clostridium sordellii which has been in- strain acceptable to the Animal and activated and is nontoxic. Each serial Plant Health Inspection Service, each of biological product containing Clos- weighing 4–8 pounds, shall be injected tridium sordellii fraction shall meet the subcutaneously with not more than applicable requirements in § 113.100 and half of the recommended cattle dose: shall be tested for purity, safety, and Provided, That, if the product is rec- potency as prescribed in this section. A ommended only for sheep, half of the serial found unsatisfactory by any pre- recommended sheep dose shall be used. scribed test shall not be released. A second dose shall be given not less (a) Purity test. Final container sam- than 20 days nor more than 23 days ples of completed product from each se- after the first dose. rial and each subserial shall be tested (3) Fourteen to seventeen days after for viable bacteria and fungi as pro- the second dose, all surviving rabbits vided in § 113.26. shall be bled, and the serum tested for (b) Safety test. Bulk or final container antitoxin content. samples of completed product from (i) At least seven rabbits are required each serial shall be tested for safety as to make an acceptable serum pool. provided in § 113.38. (ii) Equal quantities of serum from (c) Potency test. Bulk or final con- each rabbit shall be combined and test- tainer samples of completed product ed as a single pooled serum. from each serial shall be tested for po- (iii) If less than seven rabbits are tency using the toxin-neutralization available, the test is invalid and shall test provided in this paragraph. be repeated: Provided, That, if the test (1) When used in this test, the fol- is not repeated, the serial shall be de- lowing words and terms shall mean: clared unsatisfactory. (i) International antitoxin unit. (I.U.) (4) The antitoxin content of the rab- That quantity of antitoxin which re- bit serums shall be determined by the acts with Lo and L+ doses of Standard serum neutralization test as follows: Toxin according to their definitions. (i) Make a dilution of Standard Anti- (ii) Lo dose. The largest quantity of toxin to contain 1.0 international unit toxin which can be mixed with one unit of antitoxin per ml. of Standard Antitoxin and not cause (ii) Make a dilution of Standard sickness or death in injected mice. Toxin in which 1.0 Lo dose is contained

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in a volume of 1 ml or less. Make a sec- than 1.0 International Unit per ml, the ond dilution of Standard Toxin in serial is unsatisfactory. which 1.0 L+ dose is contained in a vol- [39 FR 16862, May 10, 1974, as amended at 42 ume of 1 ml or less. FR 61247, Dec. 2, 1977; 45 FR 40101, June 13, (iii) Combine 1.0 International Unit 1980. Redesignated at 55 FR 35562, Aug. 31, Standard Antitoxin with 1.0 Lo dose of 1990; 56 FR 37826, Aug. 9, 1991; 56 FR 66784, diluted Standard Toxin and combine 1.0 66785, Dec. 26, 1991] International Unit of Standard Anti- toxin with 1.0 L+ dose of diluted Stand- § 113.110 Clostridium Botulinum Type ard Toxin. Each mixture is adjusted to C Bacterin-Toxoid. a final volume of 2.0 ml with diluent. Clostridium Botulinum Type C (iv) Combine 1.0 Lo dose of diluted Bacterin-Toxoid shall be produced from Standard Toxin with a 1.0 ml volume of a culture of Clostridium botulinum Type undiluted serum. This mixture is ad- C which has been inactivated and is justed to a final volume of 2.0 ml with nontoxic. Each serial of biological diluent. product containing Clostridium botu- (v) Neutralize all toxin-antitoxin linum Type C fraction shall meet the mixtures at room temperature for 1 applicable requirements in § 113.100 and hour and hold in ice water until injec- shall be tested for purity, safety, and tions of mice can be made. potency as prescribed in this section. A (vi) Five Swiss white mice, each serial found unsatisfactory by any pre- weighing 16–20 grams, shall be used for scribed test shall not be released. each toxin-antitoxin mixture. A dose of (a) Purity test. Final container sam- 0.2 ml shall be injected intravenously ples of completed product from each se- into each mouse. Conclude the test 72 rial and each subserial shall be tested hours post injection and record all for viable bacteria and fungi as pro- deaths. vided in § 113.26. (5) Test Interpretation shall be as fol- (b) Safety test. Bulk or final container lows: samples of completed product from (i) If any mice inoculated with the each serial shall be tested for safety as mixture of 1.0 International Unit of provided in § 113.33(b). Standard Antitoxin and 1.0 Lo doses of (c) Potency test. Bulk or final con- Standard Toxin die, the results of the tainer samples of completed product serum neutralization test are inconclu- from each serial shall be tested for po- sive and shall be repeated: Provided, tency, using susceptible mink as test That, if the test is not repeated, the se- animals. At least five vaccinates and rial shall be declared unsatisfactory. three unvaccinated controls of the (ii) If less than 80 percent of the mice same source and approximately the inoculated with the mixture of 1.0 same age shall be used. International Unit of Standard Anti- (1) Each of the vaccinates shall be in- toxin and 1.0 L+ doses of Standard jected subcutaneously with the dose Toxin die, the results of the serum neu- recommended on the label for mink. tralization test are inconclusive and Twenty-one to twenty-eight days post- shall be repeated: Provided, That, if the injection, the vaccinates and the contest is not repeated, the serial shall be trols shall be challenged declared unsatisfactory. intraperitoneally with botulinum Type (iii) If any mice inoculated with the C toxin which has been titrated in mice mixture of 1.0 ml undiluted serum with to provide for a 104.0 mouse MLD dose. 1.0 Lo dose of Standard Toxin die, the The titration technique shall include serum is considered to contain less inoculation of the mice than 1.0 International Units per ml. intraperitoneally. (iv) If the single pooled serum from (2) The vaccinates and controls shall seven or more rabbits contains less be observed for 7 days post-challenge and signs of botulism and deaths noted. For a valid test, the controls shall die of botulism. If the test is valid and 80

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percent of the vaccinates do not re- toxin unit value shall be stated on the main free of botulism, the serial is un- label. satisfactory. (v) Standard toxin. The Beta toxin [39 FR 16862, May 10, 1974, as amended at 40 preparation which is supplied by or is FR 759, Jan. 3, 1975. Redesignated at 55 FR acceptable to Animal and Plant Health 35562, Aug. 31, 1990, as amended at 56 FR Inspection Service. 66785, Dec. 26, 1991] (vi) Diluent. The solution used to make proper dilutions prescribed in § 113.111 Clostridium Perfringens this test. Such solutions shall be made Type C Toxoid and Bacterin-Toxoid. by dissolving 1 gram of peptone and Clostridium Perfringens Type C Tox- 0.25 grams of sodium chloride in each oid and Clostridium Perfringens Type C 100 ml of distilled water; adjusting the Bacterin-Toxoid shall be produced from pH to 7.2; autoclaving at 250 °F for 25 a culture of Clostridium perfringens minutes; and storing at 4 °C until used. Type C which has been inactivated and (2) Each of at least eight rabbits of a is nontoxic. Each serial shall meet the strain acceptable to APHIS, each applicable requirements in § 113.100 and weighing 4–8 pounds, shall be injected shall be tested for purity, safety, and subcutaneously with not more than potency as prescribed in this section. half of the largest recommended dose Any serial found unsatisfactory by a for any species indicated on the prod- prescribed test shall not be released. uct label. A second equivalent dose (a) Purity test. Final container sam- shall be given not less than 20 days nor ples of completed product from each se- more than 23 days after the first does. rial and each subserial shall be tested (3) Fourteen to seventeen days after for viable bacteria and fungi as pro- the second dose, all surviving rabbits vided in § 113.26. shall be bled and the serum tested for (b) Safety test. Bulk or final container antitoxin content. samples of completed product from (i) At least seven rabbits are required each serial shall be tested for safety as to make an acceptable serum pool. provided in § 113.33(b). (ii) Equal quantities of serum from (c) Potency test. Bulk or final con- each rabbit shall be combined and test- tainer samples of completed product ed as a single pooled serum. from each serial shall be tested for po- (iii) If less than seven rabbits are tency using the Beta toxin-neutraliza- available, the test is invalid and shall tion test provided in this paragraph. be repeated: Provided, That, if the test (1) When used in this test, the fol- is not repeated, the serial shall be de- lowing words and terms shall mean: clared unsatisfactory. (i) International antitoxin unit. (I.U.) That quantity of Beta Antitoxin which (4) The antitoxin content of the rab- ∂ bit serums shall be determined as fol- reacts with L0 and L doses of Stand- ard Toxin according to their defini- lows: tions. (i) Make a dilution of Standard Anti- toxin to contain 10 International Units (ii) L0 dose. The largest quantity of toxin which can be mixed with one unit of antitoxin per ml. of Standard Antitoxin and not cause (ii) Make one dilution of Standard sickness or death in injected mice. Toxin to contain 10 L0 doses per ml and (iii) L∂ dose. The smallest quantity make a second dilution of Standard of toxin which can be mixed with one Toxin to contain 10 L∂ doses per ml. unit of Standard Antitoxin and cause (iii) Combine 10 International Units death in at least 80 percent of injected of Standard Antitoxin with 10 L0 doses mice. of diluted Standard Toxin and combine (iv) Standard antitoxin. The Beta 10 International Units of Standard Antitoxin preparation which has been Antitoxin with 10 L∂ doses of diluted standardized as to antitoxin unitage on Standard Toxin. the basis of the International Clos- (iv) Combine 1 ml of undiluted serum tridium perfringens Beta Antitoxin with 10 L0 doses of diluted Standard Standard and which is either supplied Toxin. by or acceptable to Animal and Plant (v) Neutralize all toxin-antitoxin Health Inspection Service. The anti- mixtures at room temperature for 1

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hour and hold in ice water until injec- each serial shall be tested for safety as tions of mice can be made. provided in § 113.33(b). (vi) Five Swiss white mice, each (c) Potency test. Bulk or final con- weighing 16–20 grams, shall be used for tainer samples of completed product each toxin-antitoxin mixture. A dose of from each serial shall be tested for po- 0.2 ml shall be injected intravenously tency using the Epsilon toxin-neutral- into each mouse. Conclude the test 24 ization test provided in this paragraph. hours post-injection and record all (1) When used in this test, the fol- deaths. lowing words and terms shall mean: (5) Test Interpretation shall be as fol- (i) International antitoxin unit. (I.U.) lows: That quantity of Epsilon Antitoxin (i) If any mice inoculated with the which reacts with L0 and L∂ doses of mixture of 10 International Units of Standard Toxin according to their defi- Standard Antitoxin and 10 L0 doses of nitions. Standard Toxin die, the results of the (ii) L0 dose. The largest quantity of test are inconclusive and shall be re- toxin which can be mixed with one- peated: Provided, That, if the test is not tenth unit of Standard Antitoxin and repeated, the serial shall be declared not cause sickness or death in injected unsatisfactory. mice. (ii) If less than 80 percent of the mice (iii) L∂ dose. The smallest quantity inoculated with mixture of 10 Inter- of toxin which can be mixed with one- national Units of Standard Antitoxin tenth unit of Standard Antitoxin and and 10 L∂ doses of Standard Toxin die, cause death in at least 80 percent of in- the results of the test are inconclusive jected mice. and shall be repeated: Provided, That, if (iv) Standard antitoxin. The Epsilon the test is not repeated, the serial shall Antitoxin preparation which has been be declared unsatisfactory. standardized as to antitoxin unitage on (iii) If any mice inoculated with the the basis of the International Clos- mixture of serum with 10 L0 doses of tridium perfringens Epsilon Antitoxin Standard Toxin die, the serum is con- Standard and which is either supplied sidered to contain less than 10 Inter- by or acceptable to Animal and Plant national Units per ml. and the serial is Health Inspection Service. The anti- unsatisfactory toxin unit value shall be stated on the label. [39 FR 16862, May 10, 1974, as amended at 40 FR 759, Jan. 3, 1975; 40 FR 41088, Sept. 5, 1975. (v) Standard toxin. The Epsilon toxin Redesignated at 55 FR 35562, Aug. 31, 1990, as preparation which is supplied by or is amended at 56 FR 66784, 66785, Dec. 26, 1991; 62 acceptable to Animal and Plant Health FR 31330, June 9, 1997] Inspection Service. (vi) Diluent. The solution used to § 113.112 Clostridium Perfringens make proper dilutions prescribed in Type D Toxoid and Bacterin-Toxoid. this test. Such solutions shall be made Clostridium Perfringens Type D Tox- by dissolving 1 gram of peptone and oid and Clostridium Perfringens Type 0.25 gram of sodium chloride in each 100 D Bacterin-Toxoid shall be produced ml of distilled water; adjusting the pH from a culture of Clostridium perfringens to 7.2; autoclaving at 250 °F for 25 min- Type D which has been inactivated and utes; and storing at 4 °C until used. is nontoxic. Each serial shall meet the (2) Each of at least eight rabbits of a applicable requirements in § 113.100 and strain acceptable to APHIS, each shall be tested for purity, safety, and weighing 4–8 pounds, shall be injected potency as prescribed in this section. subcutaneously with not more than Any serial found unsatisfactory by a half of the largest recommended dose prescribed test shall not be released. for any species indicated on the prod- (a) Purity test. Final container sam- uct label. A second equivalent dose ples of completed product from each se- shall be given not less than 20 days nor rial and each subserial shall be tested more than 23 days after the first dose. for viable bacteria and fungi as pro- (3) Fourteen to seventeen days after vided in § 113.26. the second dose, all surviving rabbits (b) Safety test. Bulk or final container shall be bled, and the serum tested for samples of completed product from antitoxin content.

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(i) At least seven rabbits are required (iii) If any mice inoculated with the to make an acceptable serum pool. mixture of serum with 10 Lo doses of (ii) Equal quantities of serum from Standard Toxin die, the serum is con- each rabbit shall be combined and test- sidered to contain less than 2 Inter- ed as a single pooled serum. national Units per ml, and the serial is (iii) If less than seven rabbits are unsatisfactory. available, the test is invalid and shall [39 FR 16865, May 10, 1974; 39 FR 20783, June be repeated: Provided, That, if the test 14, 1974. Redesignated at 39 FR 25463, July 11, is not repeated, the serial shall be de- 1974, and amended at 40 FR 759, Jan. 3, 1975; clared unsatisfactory. 40 FR 41088, Sept. 5, 1975. Redesignated at 55 (4) The antitoxin content of the rab- FR 35562, Aug. 31, 1990, as amended at 56 FR bit serums shall be determined as fol- 66784, 66785, Dec. 26, 1991; 62 FR 31331, June 9, lows: 1997] (i) Make a dilution of Standard Anti- toxin to contain 1 International Unit of § 113.113 Autogenous biologics. antitoxin per ml. Autogenous biologics shall be pre- (ii) Make one dilution of Standard pared from cultures of microorganisms Toxin to contain 10 Lo doses per ml and which have been inactivated and are make a second dilution of Standard nontoxic. Such products shall be pre- Toxin to contain 10 L∂ doses per ml. pared only for use by or under the di- (iii) Combine 1 International Unit of rection of a veterinarian under a vet- Standard Antitoxin with 10 Lo doses of erinarian-client-patient relationship, diluted Standard Toxin and Combine 1 Provided, That, such products may be International Unit of Standard Anti- prepared for use under the direction of toxin with 10 L∂ doses of diluted a person of appropriate expertise in Standard Toxin. specialized situations such as aqua- (iv) Dilute 1 ml of serum with 1 ml of culture, if approved by the Adminis- diluent (1:2) and combine 1 ml of this trator. solution with 10 Lo doses of diluted Each serial of an autogenous biologic Standard Toxin. shall meet the requirements in this (v) Neutralize all toxin-antitoxin section, and if found unsatisfactory by mixtures at room temperature for 1 any prescribed test shall not be used. hour and hold in ice water until injec- (a) Seed requirements. The microorga- tions of mice can be made. nisms used as seed to prepare autog- (vi) Five Swiss white mice, each enous biologics shall be microorga- weighing 16–20 grams, shall be used for nisms which are isolated from sick or each toxin-antitoxin mixture. A dose of dead animals in the herd of origin and 0.2 ml shall be injected intravenously which there is reason to believe are the into each mouse. Conclude the test 24 causative agent(s) of the current dis- hours post-injection and record all ease affecting such animals. deaths. (1) More than one microorganism iso- (5) Test Interpretation shall be as fol- lated from the same herd may be used lows: as seed. (i) If any mice inoculated with the (2) Under normal circumstances, mixture of 1 International Unit of microorganisms from one herd must Standard Antitoxin and 10 Lo doses of not be used to prepare an autogenous Standard Toxin die, the results of the biologic for another herd. The Adminis- test are inconclusive and shall be re- trator, however, may authorize prepa- peated: Provided, That, if the test is not ration of an autogenous biologic for repeated, the serial shall be declared use in herds adjacent to the herd of ori- unsatisfactory. gin, when adjacent herds are consid- (ii) If less than 80 percent of the mice ered to be at risk. To request author- inoculated with mixture of 1 Inter- ization to prepare a product for use in national Unit of Standard Antitoxin herds adjacent to the herd of origin, and 10 L∂ doses of Standard Toxin die, the establishment seeking authoriza- the results of the test are inconclusive tion must submit to the Administrator and shall be repeated: Provided, That, if (in c/o the Director, Center for Veteri- the test is not repeated, the serial shall nary Biologics, Inspection and Compli- be declared unsatisfactory. ance, 1920 Dayton Avenue, P.O. Box 844,

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Ames, IA 50010) the following informa- name, address, and phone number of tion. (If any of the data are unavail- the adjacent herd owner. able, the applicant for authorization (ii) The geographic designations of should indicate that such data are un- the area involved. available and why.) (iii) A summary of the epidemiology (i) Name, address, and phone number of the disease situation that links the of the owner of the herd of origin. designated geographic areas with the (ii) Attending veterinarian’s name, herd of origin. address, and phone number. In addition, an applicant for authoriza- (iii) Animal species and number in tion under this paragraph (a)(3) shall herd of origin. provide written approval from the (iv) Identification of microorga- State Veterinarian or other appro- nism(s), at least to genus. (v) Diagnosis or clinical signs of the priate State Official in the State in disease observed. which the autogenous biologic is to be (vi) Name and address of the person used in nonadjacent herds. who isolated the microorganism(s) and (4) Under normal circumstances, the date of isolation. microorganism(s) used for the produc- (vii) Number of doses of autogenous tion of autogenous biologics may not biologic requested and vaccination be older than 15 months from the date schedule. of isolation, or 12 months from the date (viii) Each adjacent herd owner’s of harvest of the first serial of product name, address, and phone number. produced from the microorganism(s), (ix) Number of animals and species in whichever comes first. The Adminis- each adjacent herd. trator, however, may authorize produc- (x) The attending veterinarian’s or tion of additional serials from micro- approved specialist’s assessment of the organism(s) older than the above stat- involvement of the adjacent herd(s) ed time periods, Provided, That, the with the disease observed. person requesting such authorization submits the following supporting infor- The applicant shall give notice to the mation to the address listed in para- State Veterinarian or other appro- graph (a)(3): priate State Official in writing when an autogenous biologic is to be used in ad- (i) The attending veterinarian’s or jacent herds. approved specialist’s current assess- (3) The Administrator may authorize ment of the continued involvement of a preparation of an autogenous biologic herd with the originally isolated for use in herds which are not adjacent microorganism(s), including a sum- to the herd of origin, but which he or mary of the diagnostic work that has she considers to be at risk of infection been done to support this assessment. with the same microorganism(s). Ex- (ii) Evidence of satisfactory protec- cept as provided below, the same infor- tion from the previous use of the au- mation which is required for prepara- togenous biologic produced from the tion of such product for use in herds microorganisms involved. adjacent to the herd of origin must be (iii) Any other information the Ad- submitted to the Administrator (in c/o ministrator may require in order to de- the Director, Center for Veterinary termine the need to use the microorga- Biologics, Inspection and Compliance, nism to make additional serials. 1920 Dayton Avenue, P.O. Box 844, (b) Restrictions. Unless otherwise au- Ames, IA 50010) for authorization to thorized by the Administrator, each se- prepare a product for use in herds not rial of an autogenous biologic shall be adjacent to the herd of origin. Because subject to the following restrictions: the recipient herd involved may not be (1) Microorganisms used to prepare known when autogenous biologics are autogenous biologics shall not be main- to be used in other geographic areas, tained in the licensed establishment the following data may be used in place beyond the time authorized for use in of the data required in paragraphs production. (a)(2)(viii) and (a)(2)(ix) of this section. (2) The expiration date of the autog- (i) Names and addresses of practi- enous biologic shall not exceed 18 tioners in the area in place of the months from the date of harvest.

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(c) Testing requirements for autogenous rial and subserial shall be tested for biologics. (1) Final container samples of viable bacteria and fungi as provided in completed product from the first serial § 113.26. When the number of final con- or subserial of an autogenous biologic tainers in a serial or subserial is 50 or produced from an isolate shall be test- less, two final container samples from ed for purity as prescribed in § 113.26, each serial and subserial shall be tested and for safety as prescribed in as prescribed in § 113.26(b): Provided, § 113.33(b) or § 113.38 except that: That, 1 ml aliquots from each sample (i) When the number of final con- may be inoculated into five cor- tainers in a serial or subserial is 50 or responding individual test vessels of less, two final container samples from each of the test media required. each serial and subserial shall be tested (ii) Safety test. Bulk of final container as prescribed in § 113.26(b): Provided, samples of completed product from That, 1 ml aliquots from each sample each serial shall be tested for safety as may be inoculated into five cor- provided in § 113.33 (b) or § 113.38. responding individual test vessels of (iii) Identification. All microorga- each of the test media required. nisms used for the production of autog- (ii) Serials which are satisfactory enous biologics shall be identified as after the third day of observation of follows: Bacteria, fungi, and myco- purity test cultures and of safety test plasma shall be identified at least to animals may be released for shipment genus and species. Viruses shall be to the customer and the tests contin- identified at least to family. After 15 ued throughout the required period; months from the date of isolation, or 12 and months from the harvest date of the (iii) Serials released on the basis of first serial of autogenous product pro- satisfactory results of third day obser- duced from a microorganism, which- vations shall be immediately recalled ever comes first, characterization and if evidence of contamination occurs in identification shall be completed to test cultures or if any of the test ani- strain and/or serotype before such mals used to demonstrate product safe- microorganism may be used for produc- ty, sicken, or die during the observation. tion period. (iv) Antigenicity, or immunogenicity, (iv) Test summaries must be sub- and potency. Persons seeking author- mitted to the Administrator (in c/o the ization to prepare additional serials of Director, Center for Veterinary Bio- autogenous biologics from microorga- logics, Inspection and Compliance, 1920 nisms that are older than 24 months Dayton Avenue, P.O. Box 844, Ames, IA from the date of isolation, shall be re- 50010) on a quarterly basis by the 21st quired to conduct the following addi- day of January, April, July, and Octo- tional tests: ber or more often as required by the (A) Completed product shall be tested Administrator. for antigenicity or immunogenicity in (2) Each serial or subserial of autog- the species for which the product is enous bacterial product other than the recommended or in another animal first serial or subserial produced from species whose immunological response an isolate shall meet the applicable has been shown in the scientific lit- general requirements prescribed in erature to correlate with the response § 113.100 and the special requirements of the species for which the product is prescribed in this section. Each serial recommended. Such tests shall be con- or subserial of autogenous viral prod- ducted in accordance with a protocol uct other than the first serial or sub- developed by the licensee and approved serial produced from an isolate shall by the Administrator and the results meet the applicable general require- submitted to the Director, Center for ments prescribed in § 113.200 and the Veterinary Biologics, Policy, Evalua- special requirements prescribed in this tion, and Licensing, 1920 Dayton Ave- section. A serial or subserial found un- nue, P.O. Box 844, Ames, IA 50010 for re- satisfactory by any prescribed test view. Microorganisms not shown to be shall not be released. antigenic (that is, not shown to induce (i) Purity test. Final container sam- a significant serological response) or ples of completed product from each se- immunogenic by such approved tests

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shall not be used for the preparation of each serial shall be tested for safety as such product. provided in § 113.33(b). (B) Bulk or final container samples (c) Potency test. Bulk or final con- of completed product from each serial tainer samples of completed product of such autogenous biologics con- from each serial shall be tested for po- taining fractions for which standard re- tency. A group of 10 guinea pigs con- quirement potency test procedures sisting of an equal number of males have been established shall be tested and females weighing 450 to 550 grams for potency in accordance with applica- shall each be injected subcutaneously ble standard requirement potency tests with 0.4 of the largest dose rec- provided in 9 CFR part 113. If the cul- ommended on the product labels. ture of microorganisms used to produce (1) Six weeks after injection, all sur- such fractions is shown to be of a dif- viving guinea pigs shall be bled and ferent strain or serotype than the rea- equal portions of serum, but not less gent or challenge microorganisms used than 0.5 ml from each, shall be pooled. in the standard requirement potency For a valid test, the pool shall contain test, reagents or challenges of the same the serum from at least eight animals. strain or serotype as the microorga- (2) The antitoxin titer of the pooled nism used for production may be used. serum shall be determined in antitoxin (C) If no standard requirement po- units (A.U.) per ml using an enzyme- tency test procedures have been estab- linked immunosorbent assay method lished for a fraction(s) in the autog- acceptable to the Animal and Plant enous biologic, such fraction(s) of each Health Inspection Service. serial of product shall be tested for po- (3) If the antitoxin titer of the serum tency using a developmental potency pool is at least 2.0 A.U. per ml, the se- test described in the filed outline of rial is satisfactory. If the antitoxin production or shall at least be stand- titer of the serum pool is less than 2.0 ardized to contain an antigenic mass A.U. per ml, the serial may be retested for such fraction(s) that has been by the following procedure: Provided, shown to be antigenic or immunogenic That, if the serial is not retested, it in accordance with paragraph shall be declared unsatisfactory. (c)(2)(iv)(A) of this section. (4) For serials in which the serum pool contains less than 2.0 A.U. per ml, [57 FR 38756, Aug. 27, 1992, as amended at 59 the individual serum that constituted FR 67616, Dec. 30, 1994; 64 FR 43044, Aug. 9, the pool may be tested by the enzyme- 1999; 67 FR 15714, Apr. 3, 2002; 75 FR 20773, linked immunosorbent assay. If at Apr. 21, 2010] least 80 percent of the individual serums have an antitoxin titer of at least § 113.114 Tetanus Toxoid. 2.0 A.U. per ml, the serial is satisfac- Tetanus Toxoid shall be produced tory. If less than 80 percent of the indi- from a culture of Clostridium tetani vidual serums have an antitoxin titer which has been inactivated and is of at least 2.0 A.U. per ml, the serial nontoxic. The toxoid may be either ab- may be retested in 10 guinea pigs using sorbed, precipitated, or purified and the procedure described in (c)(1) and (2) concentrated. Each serial of biological above. The antitoxin titer of the pooled product containing tetanus toxoid frac- serum from the guinea pigs used in the tion shall meet the applicable require- retest shall be averaged with the anti- ments in § 113.100 and shall be tested for toxin level of the pooled serum from purity, safety, and potency as pre- the initial test. If the average of the scribed in this section. A serial or sub- two pools is at least 2.0 A.U. per ml, serial found unsatisfactory by any pre- the serial is satisfactory. If the average scribed test shall not be released. of the two pools is less than 2.0 A.U. (a) Purity test. Final container sam- per ml, the serial is unsatisfactory and ples of completed product from each se- shall not be retested further. rial and subserial shall be tested for viable bacteria and fungi as provided in [39 FR 16862, May 10, 1974, as amended at 46 FR 23224, Apr. 24, 1981; 50 FR 24905, June 14, § 113.26. 1985. Redesignated at 55 FR 35562, Aug. 31, (b) Safety test. Bulk or final container 1990, as amended at 56 FR 37827, Aug. 9, 1991; samples of completed product from 56 FR 66785, Dec. 26, 1991]

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§ 113.115 Staphylococcus Aureus (4) Make serial twofold dilutions of Bacterin-Toxoid. the serum samples and conduct the Staphylococcus Aureus Bacterin- test, using 1 ml of the serial dilutions. Toxoid shall be prepared from toxoided Appropriate controls should be in- broth cultures of selected toxogenic cluded for accurate interpretations. strains of Staphylococcus aureus which (5) Add 1 ml of the standardized toxin has been inactivated and is nontoxic. containing the established ‘‘Lh’’ dose. Each serial of biological product con- The ‘‘Lh’’ dose is the amount of toxin taining Staphylococcus Aureus which when mixed with one unit of Bacterin-Toxoid shall meet the appli- standard antitoxin produces a 50 per- cable requirements in § 113.100 and shall cent hemolysis of rabbit red blood be tested for purity, safety, and po- cells. tency as prescribed in this section. A (6) Incubate toxin-antitoxin mixture serial found unsatisfactory by any pre- at room temperature for 30 minutes scribed test shall not be released. (a) Purity test. Final container sam- and add 1 ml of a 1.5 percent suspension ples of completed product from each se- of washed freshly drawn rabbit red rial shall be tested for viable bacteria blood cells suspended in normal saline and fungi as provided in § 113.26. to each tube. Mix and incubate the (b) Safety test. Bulk or final container combined product in a 37 °C water bath samples of completed product shall be for 1 hour. Refrigerate at 5 °C over- tested for safety as provided in night. § 113.33(b). Also, the rabbits used in the (7) Read the hemolysis produced and potency test provided in paragraph (c) establish the 50 percent end point. The of this section shall constitute an addi- 50 percent end point of hemolysis tional safety test. If unfavorable reac- should be established by determining tions attributable to the product occur the size of the button produced by the in any of the rabbits during the obser- unlysed red blood cells. vation period, the serial is unsatisfac- (8) Determine the units of antitoxin tory. per 1 ml of serum. (c) Potency test. Rabbits, each weigh- (9) If the individual samples from ing 2000–3000 grams, shall be used as four of the five rabbits in the indi- test animals. Either a five rabbit individual serum test or the pooled sam- vidual serum test or an eight rabbit pooled serum test shall be conducted. ples from the eight rabbits in the At the start of the test, individual se- pooled serum test do not contain three rums from the five rabbits or pooled se- alpha antitoxin units per ml, the serial rums from the eight rabbits shall con- is unsatisfactory. tain less than 0.2 alpha antitoxin units [39 FR 16862, May 10, 1974. Redesignated at 55 per ml. FR 35562, Aug. 31, 1990, as amended at 56 FR (1) Each rabbit shall be given a series 66785, Dec. 26, 1991] of not more than three intramuscular injections at 7 day intervals (1.0 ml, 2.0 § 113.116 Pasteurella Multocida ml, 3.0 ml) and observed from 7–14 days Bacterin, Avian Isolate, Type 4. following the third injection. At the Pasteurella Multocida Bacterin, end of the observation period, a blood Avian Isolate, Type 4 shall be prepared sample shall be taken from each rabbit. from cultures of Pasteurella multocida, (2) The sample of serum from each avian isolate, Type 4 (Little and Lyons rabbit, if the five rabbit individual test classification), which have been inac- is conducted or a pooled sample of equal quantities of serum from the rab- tivated, and are nontoxic. Each serial bits if the eight rabbit pooled serum of biological product containing test is conducted, shall be tested to de- Pasteurella Multocida Bacterin, Avian termine the staphylococcus alpha anti- Isolate, Type 4, shall meet the applica- toxin units per ml as provided in parable requirements in § 113.100 and shall graphs (c)(3), (4), (5), (6), (7), and (8) of be tested for purity, safety, and po- this section. tency, as prescribed in this section. A (3) Inactivate rabbit serum 56 °C for serial found unsatisfactory by any pre- 30 minutes. scribed test shall not be released.

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(a) Purity test. Final container sam- serial is unsatisfactory if the test is ples of completed product shall be test- not repeated. ed for viable bacteria and fungi as pro- Cummulative total number vided in 9 CFR 113.26. Cumu- of dead vaccinates Number lative lll (b) Safety test. Observation of the vac- Stage of vac- number for cinated turkeys during the cinates of vac- Satisfactory Unsatisfac- prechallenge period of the potency test cinates serial tory serial provided in paragraph (c) of this sec- 1 ...... 20 20 6 or less ..... 9 or more. tion shall constitute the safety test. If 2 ...... 20 40 15 or less ... 16 or more. unfavorable reactions that are attributable to the product occur, the serial (5) The serial shall pass or fail based is unsatisfactory. If unfavorable reac- on the stage one results of the potency tions that are not attributable to the test. However, the second stage may be product occur in one turkey, test re- conducted if seven or eight vaccinates sults shall be determined by observing die in stage one, but the serial is unsat- the remaining 20 turkeys. The test is isfactory if the second stage is not con- inconclusive and may be repeated if un- ducted. favorable reactions that are not attrib- (6) The second stage shall be con- utable to the product occur in two or ducted in a manner identical to the more turkeys, but the serial is unsatis- first stage. The serial shall be evalu- factory if the test is not repeated. ated according to stage two of the (c) Potency test. Bulk or final con- table. On the basis of accumulated retainer samples of completed product sults from the data of both stage tests, shall be tested for potency of the Type a serial shall either pass or fail the sec- 4 strain, using the two-stage test pro- ond stage. vided in this paragraph. Turkeys at [47 FR 5795, Feb. 4, 1982; 47 FR 6817, Feb. 17, least 6 weeks old obtained from the 1982, as amended at 52 FR 9117, Mar. 23, 1987. same source and hatch shall be prop- Redesignated at 55 FR 35562, Aug. 31, 1990, as erly identified and used as provided in amended at 56 FR 66785, Dec. 26, 1991] this paragraph. (1) Vaccinates. Each of not more than § 113.117 Pasteurella Multocida 21 turkeys shall be vaccinated with the Bacterin, Avian Isolate, Type 1. dose and by the route recommended on Pasteurella Multocida Bacterin, the label. A second dose shall be given Avian Isolate, Type 1, shall be prepared after 3 weeks and the turkeys observed from cultures of Pasteurella multocida, for an additional 2-week prechallenge avian isolate, Type 1 (Little and Lyons period. classification), which have been inac- (2) Unvaccinated controls. Each of not tivated and are nontoxic. Each serial of more than 11 turkeys shall be held as biological product containing controls. Pasteurella Multocida Bacterin, Avian (3) Challenge. Not less than 14 days Isolate, Type 1, shall meet the applica- after the second dose, each of 20 vac- ble requirements in § 113.100 and shall cinates, and each of 10 unvaccinated be tested for purity, safety, and po- controls shall be challenged tency as prescribed in this section. A intramuscularly with virulent serial found unsatisfactory by any pre- Pasteurella multocida, Strain P–1662, scribed test shall not be released. Type 4 (Little and Lyons classification) (a) Purity test. Final container sam- and observed daily for a 14-day ples of completed product shall be test- postchallenge period. Only dead birds ed for viable bacteria and fungi as pro- shall be considered in evaluating the vided in § 113.26. product. (b) Safety test. Observation of the vac- (4) Validity requirements. Eight or cinated chickens during the more unvaccinated controls must die prechallenged period of the potency for the test to be valid. If this require- test provided in paragraph (c) of this ment is met, the potency test results section shall constitute the safety test. are evaluated according to stage one of If unfavorable reactions that are at- the following table. The test is incon- tributable to the product occur, the se- clusive and may be repeated if the va- rial is unsatisfactory. If unfavorable lidity requirement is not met, but the reactions that are not attributable to

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the product occur in one chicken, test test. However, the second stage may be results shall be determined by observ- conducted if seven or eight vaccinates ing the remaining 20 chickens. The test die in stage one, but the serial is unsatis inconclusive and may be repeated if isfactory if the second stage is not con- unfavorable reactions that are not at- ducted. tributable to the product occur in two (6) The second stage shall be con- or more chickens, but the serial is un- ducted in a manner identical to the satisfactory if the test is not repeated. first stage. The serial shall be evalu- (c) Potency test. Bulk or final con- ated according to stage two of the tainer samples of completed product table. On the basis of accumulated re- shall be tested for potency of the Type sults from the data of both stage tests, 1 strain, using the two-stage test pro- a serial shall either pass or fail the sec- vided in this paragraph. Chickens, at ond stage. least 12 weeks of age, obtained from [39 FR 16866, May 10, 1974; 39 FR 20368, June the same source and hatch, shall be 10, 1974, as amended at 40 FR 759, Jan. 3, 1975; properly identified and used as pro- 40 FR 23989, June 4, 1975; 47 FR 5195, Feb. 4, vided in this paragraph. 1982; 52 FR 9118, Mar. 23, 1987. Redesignated (1) Vaccinates. Each of not more than at 55 FR 35562, Aug. 31, 1990, as amended at 56 21 chickens shall be injected with the FR 66785, Dec. 26, 1991] dose and by the route recommended on the label. A second dose shall be in- § 113.118 Pasteurella Multocida jected after 3 weeks and the chickens Bacterin, Avian Isolate, Type 3. observed for an additional 2 week Pasteurella Multocida Bacterin, prechallenge period. Avian Isolate, Type 3, shall be prepared (2) Unvaccinated controls. Each of not from culture of Pasteurella multocida, more than 11 chickens shall be held as avian isolate, Type 3 (Little and Lyons controls. classification), which have been inac- (3) Challenge. Not less than 14 days tivated and are nontoxic. Each serial of after the second injection, each of 20 biological product containing vaccinates, and each of 10 unvaccinated Pasteurella Multocida Bacterin, Avian controls shall be challenged Isolate, Type 3, shall meet the applica- intramuscularly with a minimum of 250 ble requirements in § 113.100 and shall colony-forming units of virulent be tested for purity, safety, and po- Pasteurella multocida, Strain X–73, Type tency, as prescribed in this section. A 1 (Little and Lyons classification) and serial found unsatisfactory by any pre- observed daily for a 14-day scribed test shall not be released. postchallenge period. Only dead birds (a) Purity test. Final container sam- shall be considered in evaluating the ples of completed product shall be test- product. ed for viable bacteria and fungi as pro- (4) Validity requirements. Eight or vided in § 113.26. more unvaccinated controls must die (b) Safety test. Observation of the vac- for the test to be valid. If these re- cinated turkeys during the quirement are met, the potency test re- prechallenge period of the potency test sults are evaluated according to stage provided in paragraph (c) of this sec- one of the following table. The test is tion shall constitute the safety test. If inconclusive and may be repeated if unfavorable reactions that are attrib- the validity requirements are not met, utable to the product occur, the serial but the serial is unsatisfactory if the is unsatisfactory. If unfavorable reac- test is not repeated. tions that are not attributable to the product occur in one turkey, test re- Cummulative total number Cumu- of dead vaccinates sults shall be determined by observing Number lative lll Stage of vac- number for the remaining 20 turkeys. The test is cinates of vac- Satisfactory Unsatisfac- inconclusive and may be repeated if un- cinates serial tory serial favorable reactions that are not attrib- 1 ...... 20 20 6 or less .... 9 or more. utable to the product occur in two or 2 ...... 20 40 15 or less .. 16 or more. more turkeys, but the serial is unsatisfactory if the test is not repeated. (5) The serial shall pass or fail based (c) Potency test. Bulk or final con- on the stage one results of the potency tainer samples of completed product

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shall be tested for potency of the Type sults from the data of both stage tests, 3 strain, using the two-stage test pro- a serial shall either pass or fail the sec- vided in this paragraph. Turkeys, at ond stage. least 6 weeks of age, obtained from the [39 FR 16862, May 10, 1974, as amended at 40 same source and hatch, shall be prop- FR 759, Jan. 3, 1975; 47 FR 5196, Feb. 4, 1982; erly identified and used as provided in 52 FR 9118, Mar. 23, 1987. Redesignated at 55 this paragraph. FR 35562, Aug. 31, 1990, as amended at 56 FR (1) Vaccinates. Each of not more than 66785, Dec. 26, 1991] 21 turkeys shall be injected with the dose and by the route recommended on § 113.119 Erysipelothrix Rhusiopathiae the label. A second dose shall be in- Bacterin. jected after 3 weeks and the turkeys Erysipelothrix Rhusiopathiae observed for an additional 2 week Bacterin shall be produced from a cul- prechallenge period. ture of Erysipelothrix rhusiopathiae (2) Unvaccinated controls. Each of not which has been inactivated and is more than 11 turkeys shall be held as nontoxic. Each serial of biological controls. product containing Erysipelothrix (3) Challenge. Not less than 14 days rhusiopathiae shall meet the applicable after the second injection, each of 20 requirements in § 113.100 and shall be vaccinates, and each of 10 unvaccinated tested for purity, safety, and potency controls shall be challenged as prescribed in this section. A serial intramuscularly with a minimum of 150 found unsatisfactory by any prescribed colony-forming units of virulent test shall not be released. Pasteurella multocida, Strain P–1059, (a) Purity test. Final container sam- Type 3 (Little and Lyons Classifica- ples of completed product from each se- tion) and observed daily for a 14-day rial and each subserial shall be tested postchallenge period. Only dead birds for viable bacteria and fungi as pro- shall be considered in evaluating the vided in § 113.26. product. (b) Safety test. Bulk or final container (4) Validity requirements. Eight or samples of completed product from more unvaccinated controls must die each serial shall be tested for safety as for the test to be valid. If these re- provided in § 113.38. quirements are met, the potency test (c) Potency test. Bulk or final con- results are evaluated according to tainer samples of completed product stage one of the following table. The from each serial shall be tested for po- test is inconclusive and may be re- tency using the mouse protection test peated if the validity requirements are provided in this paragraph. A mouse not met, but the serial is unsatisfac- dose shall be 1⁄10 of the least dose rec- tory if the test is not repeated. ommended on the label for swine. Such swine dose shall not be less than 1 ml. Cummulative total number Cumu- of dead vaccinates (1) The ability of the bacterin being Number lative lll Stage of vac- number for tested (Unknown) to protect mice shall cinates of vac- Satisfactory Unsatisfac- be compared with a Standard Reference cinates serial tory serial Bacterin (Standard) which is either 1 ...... 20 20 6 or less ..... 9 or more. supplied by or acceptable to Animal 2 ...... 20 40 15 or less ... 16 or more. and Plant Health Inspection Service. (2) At least three threefold dilutions (5) The serial shall pass or fail based shall be made with the Standard and on the stage one results of the potency the same threefold dilutions shall be test. However, the second stage may be made for each Unknown. Dilutions conducted if seven or eight vaccinates shall be made with physiological saline die in stage one, but the serial is unsat- solution. isfactory if the second stage is not con- (3) For each dilution of the Standard ducted. and each dilution of an Unknown, a (6) The second stage shall be con- group of at least 20 mice, each weigh- ducted in a manner identical to the ing 16 to 22 grams, shall be used. Each first stage. The serial shall be evalu- mouse in each group shall be injected ated according to stage two of the subcutaneously with one mouse dose of table. On the basis of accumulated re- the appropriate dilution.

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(4) Each of 20 injected mice from each ner identical to the initial test. The av- group shall be challenged erage of the RP values obtained in the subcutaneously 14 to 21 days after retests shall be determined. If the aver- being injected. A dose containing at age RP is less than 0.6, the serial is un- least 100 mouse LD50 of a suitable cul- satisfactory without further testing. If ture of Erysipelothrix rhusiopathiae shall the average RP obtained in the retests be used. All survivors in each group of is equal to or greater than 0.6, the fol- mice shall be recorded 10 days lowing shall apply: postchallenge. (i) If the RP obtained in the original (5) Test for valid assay: At least two test is one-third or less than the aver- dilutions of the Standard shall protect age RP obtained in the retests, the ini- more than 0 percent and two dilutions tial RP may be considered a result of shall protect less than 100 percent of test system error and the serial is sat- the mice injected. The lowest dilution isfactory for potency. of the Standard shall protect more (ii) If the RP value obtained in the than 50 percent of the mice. The high- original test is more than one-third the est dilution of the Standard shall pro- average RP obtained in the retests, a tect less than 50 percent of the mice. new average shall be determined using (6) The relative potency (RP) of the the RP values obtained in all tests. If Unknown is determined by comparing the new average is less than 0.6, the se- the 50 percent endpoint dilution (high- rial is unsatisfactory. est bacterin dilution protecting 50 percent of the mice) of the Unknown with [39 FR 16862, May 10, 1974, as amended at 40 FR 759, Jan. 3, 1975; 40 FR 20067, May 8, 1975; that of the standard by the following 40 FR 51414, Nov. 5, 1975; 44 FR 71408, Dec. 11, formula: 1979; 50 FR 23795, June 6, 1985; 51 FR 23731, July 1, 1986. Redesignated at 55 FR 35562, reciprocal of 50 percent Aug. 31, 1990; 56 FR 66558, Dec. 24, 1991; 56 FR endpoint dilution of Unknown 66784, 66785, Dec. 26, 1991] RP = reciprocal of 50 percent § 113.120 Salmonella Typhimurium endpoint dilution of Standard Bacterin. (7) If the RP of the Unknown is less Salmonella Typhimurium Bacterin than 0.6, the serial being tested is un- shall be prepared from a culture of Sal- satisfactory. monella typhimurium which has been in- (8) If the 50 percent endpoint of an activated and is nontoxic. Each serial Unknown in a valid test cannot be cal- of biological product containing Sal- culated because the lowest dilution monella typhimurium fraction shall does not exceed 50 percent protection, meet the applicable requirements in that serial may be retested in a man- § 113.100 and shall be tested for purity, ner identical to the initial test: Pro- safety, and potency as prescribed in vided, That, if the Unknown is not re- this section. A serial found unsatisfac- tested or if the protection provided by tory by any prescribed test shall not be the lowest dilution of the Standard ex- released. ceeds the protection provided by the (a) Purity test. Final container sam- lowest dilution of the Unknown by six ples of completed product shall be test- mice or more; or, if the total number of ed for viable bacteria and fungi as pro- mice protected by the Standard ex- vided in § 113.26. ceeds the total number of mice pro- (b) Safety test. Bulk or final container tected by the Unknown by eight mice samples of completed product from or more, the serial is unsatisfactory. each serial shall be tested for safety as (9) If the 50 percent endpoint of an provided in § 113.33(b). Unknown in a valid test cannot be cal- (c) Potency test. Bulk or final con- culated because the highest dilution tainer samples of completed product exceeds 50 percent protection, the Un- from each serial shall be tested for po- known is satisfactory without addi- tency using the mouse test provided in tional testing. this paragraph. A mouse dose shall be (10) If the RP is less than 0.6, the se- 1⁄20 of the least dose recommended on rial may be retested by conducting two the label for other animals which shall independent replicate tests in a man- not be less than 2 ml.

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(1) The ability of the bacterin being retested in a manner identical to the tested (Unknown) to protect mice shall initial test; Provided, That, if the Un- be compared with a Standard Reference known is not retested or if the protec- Bacterin (Standard) which is either tion provided by the lowest dilution of supplied by or acceptable to Animal the Unknown by six mice or more; or, and Plant Health Inspection Service. if the total number of mice protected (2) At least three tenfold dilutions by the Standard exceeds the total num- shall be made with the Standard and ber of mice protected by the Unknown the same tenfold dilutions shall be by eight mice or more, the serial being made for each Unknown. The dilutions tested is unsatisfactory. shall be made in Phosphate Buffered (9) If the 50 percent endpoint of an Saline. Unknown in a valid test cannot be cal- (3) For each dilution of the Standard culated because the highest dilution and each dilution of an Unknown, a exceeds 50 percent protection, the Un- group of at least 20 mice, each weigh- known is satisfactory without addi- ing 16-22 grams, shall be used. Each tional testing. mouse in a group shall be injected (10) If the RP is less than the min- intraperitoneally with one mouse dose imum required in paragraph (c)(7) of of the appropriate dilution. Each this section, the serial may be retested mouse shall be revaccinated on day 14, by conducting two independent rep- using the same schedule. licate tests in a manner identical to (4) Each of 20 vaccinated mice per the initial test. The average of the RP group shall be challenged values obtained in the retests shall be intraperitoneally 7–10 days after the determined. If the average RP is less second vaccination with a 0.25 ml dose than the required minimum, the serial containing 100-10,000 mouse LD50 as de- is unsatisfactory. If the average RP ob- termined by titration, of a suitable cul- tained in the retests is equal to or ture of Salmonella typhimurium. All sur- greater than the required minimum, vivors in each group of mice shall be the following shall apply: recorded 14 days postchallenge. (5) Test for valid assay: At least two (i) If the RP obtained in the original dilutions of the Standard shall protect test is one-third or less than the aver- more than 0 percent and two dilutions age RP obtained in the retests, the ini- shall protect less than 100 percent of tial RP may be considered a result of the mice injected. The lowest dilution test system error and the serial is sat- of the Standard shall protect more isfactory. than 50 percent of the mice. The high- (ii) If the RP value obtained in the est dilution of the Standard shall pro- original test is more than one-third the tect less than 50 percent of the mice. average RP obtained in the retests, a (6) The relative potency (RP) of the new average shall be determined using Unknown is determined by comparing the RP values obtained in all tests. If the 50 percent endpoint dilution (high- the new average is less than the min- est bacterin dilution protecting 50 per- imum required in paragraph (c)(7) of cent of the mice) of the Unknown with this section, the serial is unsatisfac- that of the Standard by the following tory. formula: [40 FR 17003, Apr. 16, 1975, as amended at 42 FR 59487, Nov. 18, 1977; 48 FR 31008, July 6, reciprocal of 50 percent 1983. Redesignated at 55 FR 35562, Aug. 31, endpoint dilution of Unknown 1990, as amended at 56 FR 66784, 66785, Dec. RP = 26, 1991] reciprocal of 50 percent endpoint dilution of Standard § 113.121 Pasteurella Multocida (7) If the RP of the Unknown is less Bacterin. than 0.30, the serial being tested is un- Pasteurella Multocida Bacterin shall satisfactory. be prepared from a culture of (8) If the 50 percent endpoint of an Pasteurella multocida strains other than Unknown cannot be calculated because avian which have been inactivated and the lowest dilution does not exceed 50 are nontoxic. Each serial of biological percent protection, that serial may be product containing Pasteurella

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multocida fraction shall meet the appli- of the Standard shall protect more cable requirements in § 113.100 and shall than 50 percent of the mice. The high- be tested for purity, safety, and po- est dilution of the Standard shall pro- tency as prescribed in this section. A tect less than 50 percent of the mice. serial found unsatisfactory by any pre- (6) The relative potency (RP) of the scribed test shall not be released. Unknown is determined by comparing (a) Purity test. Final container sam- the 50 percent endpoint dilution (high- ples of completed product from each se- est bacterin dilution protecting 50 per- rial and each subserial shall be tested cent of the mice) of the Unknown with for viable bacteria and fungi as pro- that of the Standard by the following vided in § 113.26. formula: (b) Safety test. Bulk or final container samples of completed product from reciprocal of 50 percent each serial shall be tested for safety as endpoint dilution of Unknown RP = provided in § 113.33(b). The subcuta- reciprocal of 50 percent neous route is to be used. (c) Potency test. Bulk or final con- endpoint dilution of Standard tainer samples of completed product (7) If the RP of the Unknown is less from each serial shall be tested for po- than 0.50, the serial being tested is un- tency using the mouse test provided in satisfactory. this paragraph. A mouse dose shall be (8) If the 50 percent endpoint of an 1⁄20 of the least dose recommended on Unknown cannot be calculated because the label for other animals which shall the lowest dilution does not exceed 50 not be less than 2 ml. percent protection, that serial may be (1) The ability of the bacterin being retested in a manner identical to the tested (Unknown) to protect mice shall initial test: Provided, That, if the Un- be compared with a Standard Reference known is not retested or if the protec- Bacterin (Standard) which is either tion provided by the lowest dilution of supplied by or acceptable to Animal the Standard exceeds the protection and Plant Health Inspection Service. provided by the lowest dilution of the (2) At least three fivefold dilutions Unknown by six mice or more; or, if shall be made with the Standard and the total number of mice protected by the same fivefold dilutions shall be the Standard exceeds the total number made for each Unknown. The dilutions of mice protected by the Unknown by will be made in Phosphate Buffered Sa- eight mice or more, the serial being line. tested is unsatisfactory. (3) For each dilution of the Standard (9) If the 50 percent endpoint of an and each dilution of each Unknown, a Unknown in a valid test cannot be cal- group of at least 20 mice, each weigh- culated because the highest dilution ing 16–22 grams, shall be used. Each exceeds 50 percent protection, the Un- mouse in a group shall be injected known is satisfactory without addi- intraperitoneally with one mouse dose tional testing. of the appropriate dilution. Each (10) If the RP is less than the min- mouse shall be revaccinated on day 14, imum required in paragraph (c)(7) of using the same schedule. this section, the serial may be retested (4) Each of 20 injected mice per group by conducting two independent rep- shall be challenged intraperitoneally licate tests in a manner identical to 10–12 days after the second vaccination the initial test. The average of the RP with a 0.2 ml dose containing 100–10,000 values obtained in the retests shall be mouse LD50, as determined by titra- determined. If the average RP is less tion, of a suitable culture of Pasteurella than the required minimum, the serial multocida. All survivors in each group is unsatisfactory. If the average RP ob- of mice shall be recorded 10 days tained in the retests is equal to or postchallenge. greater than the required minimum, (5) Test for valid assay: At least two the following shall apply: dilutions of the Standard shall protect (i) If the RP obtained in the original more than 0 percent and two dilutions test is one-third or less than the aver- shall protect less than 100 percent of age RP obtained in the retests, the ini- the mice injected. The lowest dilution tial RP may be considered a result of

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test system error and the serial is sat- made for each Unknown. The dilutions isfactory. shall be made in Phosphate-Buffered (ii) If the RP value obtained in the Saline. original test is more than one-third the (3) For each dilution of the Standard average RP obtained in the retests, a and each dilution of an Unknown, a new average shall be determined using group of at least 20 mice, each weigh- the RP values obtained in all tests. If ing 16 to 22 grams, shall be used. Each the new average is less than the min- mouse in a group shall be injected imum required in paragraph (c)(7) of intraperitoneally with one mouse dose this section, the serial is unsatisfac- of the appropriate dilution. Each tory. mouse shall be revaccinated on day 14, [40 FR 17004, Apr. 16, 1975, as amended at 42 using the same schedule. FR 59487, Nov. 18, 1977; 48 FR 31008, July 6, (4) Each of 20 vaccinated mice per 1983. Redesignated at 55 FR 35562, Aug. 31, group shall be challenged 1990, as amended at 56 FR 66784, 66785, Dec. intraperitoneally 7 to 10 days after the 26, 1991] second vaccination with a 0.25 ml dose containing 10–1,000 mouse LD50 as de- § 113.122 Salmonella Choleraesuis termined by titration of a suitable cul- Bacterin. ture of Salmonella choleraesuis. All sur- Salmonella Choleraesuis Bacterin vivors in each group of mice shall be shall be prepared from a culture of Sal- recorded 14 days postchallenge. monella choleraesuis which has been in- (5) Test for valid assay: At least two activated and is nontoxic. Each serial dilutions of the Standard shall protect of biological product containing Sal- more than 0 percent and two dilutions monella choleraesuis fraction shall meet shall protect less than 100 percent of the applicable requirements in 9 CFR the mice injected. The lowest dilution 113.100 and shall be tested for purity, of the Standard shall protect more safety, and potency as prescribed in than 50 percent of the mice. The high- this section. A serial found unsatisfac- est dilution of the Standard shall pro- tory by any prescribed test shall not be tect less than 50 percent of the mice. released. (6) The relative potency (RP) of the (a) Purity test. Final container sam- Unknown is determined by comparing ples of completed product shall be test- the 50 percent endpoint dilution (high- ed for viable bacteria and fungi as pro- est bacterin dilution protecting 50 per- vided in 9 CFR 113.26. cent of the mice) of the Unknown with (b) Safety test. Bulk or final container that of the Standard by the following samples of completed product from formula: each serial shall be tested for safety as provided in 9 CFR 113.33(b). reciprocal of 50 percent The subcutaneous route shall be used endpoint dilution of Unknown RP = when the product is in combination reciprocal of 50 percent with Pasteurella Multocida Bacterin. (c) Potency test. Bulk or final con- endpoint dilution of Standard tainer samples of completed product (7) If the RP of the Unknown is less from each serial shall be tested for po- than 0.50, the serial being tested is un- tency using the mouse test provided in satisfactory. this paragraph. A mouse dose shall be (8) If the 50 percent endpoint of an 1⁄20 of the least dose recommended on Unknown cannot be calculated because the label for other animals which shall the lowest dilution does not exceed 50 not be less than 2 ml. percent protection, that serial may be (1) The ability of the bacterin being retested in a manner identical to the tested (Unknown) to protect mice shall initial test; Provided, That, if the Un- be compared with a Standard Reference known is not retested or if the protec- Bacterin (Standard) which is either tion provided by the lowest dilution of supplied by or acceptable to Veterinary the Standard exceeds the protection Services. provided by the lowest dilution of the (2) At least three fivefold dilutions Unknown by six mice or more; or, if shall be made with the Standard and the total number of mice protected by the same fivefold dilution shall be the Standard exceeds the total number

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of mice protected by the Unknown by (b) Safety test. Bulk or final container eight mice or more, the serial being samples of completed product from tested is unsatisfactory. each serial shall be tested for safety as (9) If the 50 percent endpoint of an provided in 9 CFR 113.33(b). Unknown in a valid test cannot be cal- (c) Potency test. Bulk or final con- culated because the highest dilution tainer samples of completed product exceeds 50 percent protection, the Un- from each serial shall be tested for po- known is satisfactory without addi- tency using the mouse test provided in tional testing. this paragraph. A mouse dose shall be (10) If the RP is less than the min- 1⁄20 of the least dose recommended on imum required in paragraph (c)(7) of the label for other animals which shall this section, the serial may be retested not be less than 2 ml. by conducting two independent rep- (1) The ability of the bacterin being licate tests in a manner identical to tested (Unknown) to protect mice shall the initial test. The average of the RP be compared with a Standard Reference values obtained in the retests shall be Bacterin (Standard) which is either determined. If the average RP is less supplied by or acceptable to Veterinary than the required minimum, the serial Services. is unsatisfactory. If the average RP ob- (2) At least three tenfold dilutions tained in the retests is equal to or shall be made with the Standard and greater than the required minimum, the same tenfold dilutions shall be the following shall apply: made for each Unknown. The dilutions (i) If the RP obtained in the original shall be made in Phosphate-Buffered test is one-third or less than the aver- Saline. age RP obtained in the retests, the ini- (3) For each dilution of the Standard tial RP may be considered a result of and each dilution of an Unknown, a test system error and the serial is sat- group of at least 20 mice, each weigh- isfactory. ing 16 to 22 grams, shall be used. Each (ii) If the RP value obtained in the mouse in a group shall be injected original test is more than one-third the intraperitoneally with one mouse dose average RP obtained in the retests, a of the appropriate dilution. Each new average shall be determined using mouse shall be revaccinated on day 14, the RP values obtained in all tests. If using the same schedule. the new average is less than the min- (4) Each of 20 vaccinated mice per imum required in paragraph (c)(7) of group shall be challenged this section, the serial is unsatisfac- intraperitoneally 7 to 10 days after the tory. second vaccination with a 0.25 ml dose [43 FR 25077, June 9, 1978, as amended at 48 containing 1,000–100,000 mouse LD50 as FR 31008, July 6, 1983. Redesignated at 55 FR determined by titration of a suitable 35562, Aug. 31, 1990, as amended at 56 FR culture of Salmonella dublin. All sur- 66785, Dec. 26, 1991] vivors in each group of mice shall be recorded 14 days postchallenge. § 113.123 Salmonella Dublin Bacterin. (5) Test for valid assay: At least two Salmonella Dublin Bacterin shall be dilutions of the Standard shall protect prepared from a culture of Salmonella more than 0 percent and two dilutions dublin which has been inactivated and shall protect less than 100 percent of is nontoxic. Each serial of biological the mice injected. The lowest dilution product containing Salmonella dublin of the Standard shall protect more fraction shall meet the applicable re- than 50 percent of the mice. The high- quirements in 9 CFR 113.100 and shall est dilution of the Standard shall probe tested for purity, safety, and po- tect less than 50 percent of the mice. tency as prescribed in this section. A (6) The relative potency (RP) of the serial found unsatisfactory by any pre- Unknown is determined by comparing scribed test shall not be released. the 50 percent endpoint dilution (high- (a) Purity test. Final container sam- est bacterin dilution protecting 50 per- ples of completed product shall be test- cent of the mice) of the Unknown with ed for viable bacteria and fungi as pro- that of the Standard by the following vided in 9 CFR 113.26. formula:

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this section, the serial is unsatisfac- reciprocal of 50 percent tory. endpoint dilution of Unknown RP = [43 FR 25077, June 9, 1978, as amended at 48 reciprocal of 50 percent FR 31009, July 6, 1983. Redesignated at 55 FR endpoint dilution of Standard 35562, Aug. 31, 1990, as amended at 56 FR 66785, Dec. 26, 1991] (7) If the RP of the Unknown is less than 0.30, the serial being tested is un- KILLED VIRUS VACCINES satisfactory. (8) If the 50 percent endpoint of an § 113.200 General requirements for Unknown cannot be calculated because killed virus vaccines. the lowest dilution does not exceed 50 When prescribed in an applicable percent protection, that serial may be Standard Requirement or in the filed retested in a manner identical to the Outline of Production, a killed virus initial test; Provided, That, if the Un- vaccine shall meet the applicable re- known is not retested or if the protec- quirements in this section. tion provided by the lowest dilution of (a) Killing agent. The vaccine virus the Standard exceeds the protection shall be killed (inactivated) by an ap- provided by the lowest dilution of the propriate agent. The procedure in- Unknown by six mice or more; or, if volved may be referred to as inactiva- the total number of mice protected by tion. Suitable tests to assure complete the Standard exceeds the total number inactivation shall be written into the of mice protected by the Unknown by filed Outline of Production. eight mice or more, the serial being (b) Cell culture requirements. If cell tested is unsatisfactory. cultures are used in the preparation of (9) If the 50 percent endpoint of an the vaccine, primary cells shall meet Unknown in a valid test cannot be cal- the requirements in § 113.51 and cell culated because the highest dilution lines shall meet the requirements in exceeds 50 percent protection, the Un- § 113.52. known is satisfactory without addi- (c) Purity tests—(1) Bacteria and fungi. tional testing. Final container samples of completed (10) If the RP is less than the min- product from each serial shall be tested imum required in paragraph (c)(7) of as prescribed in § 113.26. this section, the serial may be retested (2) Avian origin vaccine. Bulk pooled by conducting two independent rep- material or final container samples licate tests in a manner identical to from each serial shall also be tested the initial test. The average of the RP for: values obtained in the retests shall be (i) Salmonella contamination as predetermined. If the average RP is less scribed in § 113.30; and than the required minimum, the serial (ii) Lymphoid leukosis virus contami- is unsatisfactory. If the average RP ob- nation as prescribed in § 113.31; and tained in the retests is equal to or (iii) Hemagglutinating viruses as pre- greater than the required minimum, scribed in § 113.34. the following shall apply: (3) Mycoplasma. If the licensee cannot (i) If the RP obtained in the original demonstrate that the agent used to kill test is one-third or less than the aver- the vaccine virus would also kill myco- age RP obtained in the retests, the ini- plasma, each serial of the vaccine shall tial RP may be considered a result of be tested for mycoplasma as prescribed test system error and the serial is sat- in § 113.28, prior to adding the killing isfactory. agent. Material found to contain myco- (ii) If the RP value obtained in the plasma is unsatisfactory for use. original test is more than one-third the (4) Extraneous viruses. Each lot of average RP obtained in the retests, a Master Seed Virus used to prepare new average shall be determined using killed virus vaccine recommended for the RP values obtained in all tests. If animals other than poultry shall meet the new average is less than the min- the requirements for extraneous vi- imum required in paragraph (c)(7) of ruses as prescribed in § 113.55.

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(d) Safety tests. Final container sam- titer specified in the Outline of Produc- ples of completed product from each se- tion. rial shall be tested for safety in guinea (1) Twenty-five canine distemper sus- pigs as prescribed in § 113.38 and for ceptible dogs (20 vaccinates and 5 con- safety in mice as prescribed in § 113.33: trols) shall be used as test animals. Provided, That, vaccines recommended Blood samples drawn from each dog for use only in poultry are exempt from shall be individually tested for neutral- this requirement. izing antibody against canine dis- (e) Viricidal activity test. Only serials temper to determine susceptibility. A tested for viricidal activity in accord- constant virus-varying serum neutral- ance with the test provided in § 113.35 ization test in cell culture using 50 to and found satisfactory by such test 300 TCID50 of virus shall be used. Dogs shall be packaged as diluent for des- shall be considered susceptible if there iccated fractions in combination pack- is no neutralization at a 1:2 final serum ages. dilution. (f) Formaldehyde content. If formalde- (i) The 20 dogs used as vaccinates hyde is used as the killing agent, the shall be injected with one dose of vac- residual free formaldehyde content cine by the method recommended on must not exceed 0.74 grams per liter (g/ the label. If a second dose is rec- L) as determined using the ferric chlo- ommended, the second dose shall be ad- ride test. 3 Firms currently using tests ministered at the time specified on the for residual free formaldehyde content label. other than the ferric chloride test have (ii) At least 14 days after the last in- until July 14, 2004 to update their Out- oculation, the vaccinates and controls line of Production to be in compliance shall each be challenged with this requirement. intracerebrally with canine distemper virus furnished or approved by the Ani- [39 FR 27428, July 29, 1974, as amended at 40 mal and Plant Health Inspection Serv- FR 23989, June 4, 1975; 43 FR 49528, Oct. 24, ice and observed each day for 21 days. 1978. Redesignated at 55 FR 35562, Aug. 31, (iii) If at least four of the five con- 1990; 68 FR 35283, June 13, 2003] trols do not die and the survivor, if any, does not show clinical signs of ca- § 113.201 Canine Distemper Vaccine, nine distemper, the test is inconclusive Killed Virus. and may be repeated. Canine Distemper Vaccine, Killed (iv) If at least 19 of the 20 vaccinated Virus, shall be prepared from virus- do not survive without showing clinical bearing cell culture fluids. Only Master signs of canine distemper during the Seed Virus which has been established observation period, the Master Seed as pure, safe, and immunogenic shall be Virus is unsatisfactory. used for vaccine production. All serials (c) Test requirements for release. Each of vaccine shall be prepared from the serial shall meet the applicable general first through the fifth passage from the requirements prescribed in § 113.200 and Master Seed Virus. the special requirements for safety and (a) The Master Seed Virus shall meet potency provided in this section. the applicable general requirements (1) Safety test. The vaccinates used in prescribed in § 113.200. the potency test in paragraph (c)(2) of (b) The immunogenicity of vaccine this section shall be observed each day prepared from the Master Seed Virus in during the postvaccination observation accordance with the Outline of Produc- period. If unfavorable reactions occur tion shall be established. Vaccine used which are attributable to the vaccine, for this test shall be at the highest pas- the serial is unsatisfactory. If unfavor- sage from the Master Seed and pre- able reactions occur which are not at- pared at the minimum preinactivation tributable to the vaccine, the test is inconclusive and may be repeated: Pro- vided, That, if the test is not repeated, 3 The procedures for performing the ferric chloride test for residual free formaldehyde the serial is unsatisfactory. may be obtained from USDA, APHIS, Center (2) Potency test—serum neutralization for Veterinary Biologics-Laboratory, 1800 test. Bulk or final container samples of Dayton Road, P.O. Box 844, Ames, IA 50010. completed product shall be tested for

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potency using five susceptible dogs if any of the vaccinates show signs or (four vaccinates and one control) as the dies of canine distemper, the serial is test animals. Blood samples drawn unsatisfactory. from each dog shall be individually [60 FR 14359, Mar. 17, 1995] tested for neutralizing antibody against canine distemper virus to de- § 113.202 Canine Hepatitis and Canine termine susceptibility. Adenovirus Type 2 Vaccine, Killed (i) A constant virus-varying serum Virus. neutralization test in tissue culture Canine Hepatitis and Canine using 50 to 300 TCID50 of virus shall be Adenovirus Type 2 Vaccine, Killed used. Dogs shall be considered suscep- Virus, shall be prepared from virus- tible if there is no neutralization at a bearing cell culture fluids. Only Master 1:2 final serum dilution. Seed Virus which has been established (ii) Vaccination. Each of the four vac- as pure, safe, and immunogenic shall be cinates shall be injected as rec- used for vaccine production. All serials ommended on the label. If two doses of vaccine shall be prepared from the are recommended, the second dose first through the fifth passage from the shall be administered at the time spec- Master Seed Virus. ified on the label. The dogs shall be ob- (a) The Master Seed Virus shall meet served each day for at least 14 days the applicable requirements prescribed after the last inoculation. in § 113.200. (iii) Serology. At the end of the post (b) Each lot of Master Seed Virus vaccination observation period, a sec- used for vaccine production shall be ond blood sample shall be obtained tested for immunogenicity by one or from each of the five dogs and the se- both of the following methods. Vaccine rums shall be individually tested for used for these tests shall be at the neutralizing antibody against canine highest passage from the Master Seed distemper virus in the same manner and prepared at the minimum used to determine susceptibility. preinactivation titer specified in the (iv) Interpretation of the serum neutral- Outline of Production. ization test. If the control has not re- (1) Immunogenicity for canine hepatitis. mained seronegative at 1:2, the test is Twenty-five canine hepatitis suscep- inconclusive and may be repeated. If at tible dogs shall be used as test animals least three of the four vaccinates in a (20 vaccinates and 5 controls). Blood valid test have not developed titers samples shall be drawn from these ani- based upon a final serum dilution of at mals and individual serum samples least 1:50 and the remaining vaccinate tested. The dogs shall be considered has not developed a titer of at least susceptible if the results are negative 1:25, the serial is unsatisfactory except at a 1:2 final serum dilution in a vary- as provided in paragraphs (c)(2)(v) and ing serum-constant virus neutraliza- (vi) of this section. tion test using 50 to 300 TCID50 of ca- (v) Virus challenge test. If the results nine adenovirus. of a valid serum neutralization test are (i) The 20 dogs to be used as vac- unsatisfactory, the vaccinates and the cinates shall be injected with one dose control may be challenged of vaccine and the remaining five dogs intracerebrally with a virulent canine held as controls. If a second dose is rec- distemper virus furnished or approved ommended, the second dose shall be ad- by the Animal and Plant Health In- ministered at the time specified on the spection Service and each animal ob- label. served each day for an additional 21 (ii) Not less than 14 days after the days. last inoculation, each vaccinate and (vi) Interpretation of the virus chal- control shall be challenged intra- lenge test. For a serial to be satisfac- venously with virulent infectious ca- tory, all vaccinates must remain free nine hepatitis virus furnished or ap- from clinical signs of canine distemper proved by the Animal and Plant Health while the control must die of canine Inspection Service and observed each distemper. If the control does not die of day for 14 days. canine distemper, the test is inconclu- (iii) If at least four of the five con- sive and may be repeated except, that trols do not show severe clinical signs

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of infectious canine hepatitis, the test (1) Safety test. The vaccinates used in is inconclusive and may be repeated. the potency test in paragraph (c)(2) (iv) If at least 19 of the 20 vaccinates and/or (c)(3) of this section shall be ob- do not survive without showing clinical served each day during the signs of infectious canine hepatitis dur- postvaccination observation period. If ing the observation period, the Master unfavorable reactions occur which are Seed Virus is unsatisfactory. attributable to the vaccine, the serial (2) Immunogenicity for canine is unsatisfactory. If unfavorable reac- adenovirus type 2. Thirty canine tions occur which are not attributable adenovirus type 2 susceptible dogs to the vaccine, the test is inconclusive shall be used as test animals (20 vac- and may be repeated: Provided, That, if cinates and 10 controls). Blood samples not repeated, the serial is unsatisfac- shall be drawn from these animals and tory. individual serum samples tested. The (2) Potency test for canine hepatitis— dogs shall be considered susceptible if serum neutralization test. Bulk or final the results are negative at a 1:2 final container samples of completed prod- serum dilution in a varying serum-con- uct shall be tested for potency using at stant virus neutralization test using 50 least five susceptible dogs (four vac- to 300 TCID50 of canine adenovirus. cinates and one control) as the test (i) The 20 dogs to be used as vac- animals. Blood samples drawn from cinates shall be injected with one dose each dog shall be individually tested of vaccine and the remaining 10 dogs for neutralizing antibody against ca- held as controls. If a second dose is rec- nine adenovirus to determine suscepti- ommended, the second dose shall be ad- bility. ministered at the time specified on the (i) A constant virus-varying serum label. neutralization test in tissue culture (ii) Not less than 14 days after the using 50 to 300 TCID50 of virus shall be last inoculation, the vaccinates and used. Dogs shall be considered suscep- the controls shall be challenged by ex- tible if there is no neutralization at a posure to a nebulized aerosol of viru- 1:2 final serum dilution. lent canine adenovirus type 2 furnished (ii) Vaccination. Each of the vac- or approved by the Animal and Plant cinates shall be injected as rec- Health Inspection Service and observed ommended on the label. If two doses each day for 14 days postchallenge. The are recommended, the second dose rectal temperature of each animal shall be administered at the time spec- shall be taken and the presence of res- ified on the label. The dogs shall be ob- piratory or other clinical signs of ca- served each day for at least 14 days nine adenovirus type 2 noted and re- after the last inoculation. corded each day. (iii) Serology. At the end of the (iii) If at least 6 of 10 controls do not postvaccination observation period, a show clinical signs of canine second blood sample shall be obtained adenovirus type 2 infection other than from each of the dogs and the serums fever, the test is inconclusive and may shall be individually tested for neutral- be repeated. izing antibody against canine (iv) If a significant difference in clin- adenovirus in the same manner used to ical signs in a valid test cannot be determine susceptibility. demonstrated between vaccinates and (iv) Interpretation of the serum neutral- controls using a scoring system ap- ization test. If the control(s) has not re- proved by the Animal and Plant Health mained seronegative at 1:2, the test is Inspection Service, the Master Seed inconclusive and may be repeated. If at Virus is unsatisfactory. least 75 percent of the vaccinates in a (c) Test requirements for release. Each valid test have not developed titers serial shall meet the applicable general based upon final serum dilution of at requirements prescribed in § 113.200, the least 1:10 and the remaining vac- special requirements for safety pro- cinate(s) has not developed a titer of at vided in this section, and the applica- least 1:2, the serial is unsatisfactory ble potency tests provided in this sec- except as provided in paragraphs tion. (c)(2)(v) and (vi) of this section.

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(v) Virus challenge test. If the results (iv) If at least two of three controls of a valid serum neutralization test are do not show clinical signs of canine unsatisfactory, the vaccinates and the adenovirus type 2 other than fever, the control(s) may be challenged intra- test is inconclusive and may be re- venously with a virulent canine hepa- peated. titis virus furnished or approved by the (v) If a significant difference in clin- Animal and Plant Health Inspection ical signs cannot be demonstrated be- Service and each animal observed each tween vaccinates and controls using a day for an additional 14 days. scoring system approved by the Animal (vi) Interpretation of the virus chal- and Plant Health Inspection Service lenge test. For a serial to be satisfac- and prescribed in the Outline of Pro- tory, all vaccinates must remain free duction, the serial is unsatisfactory. of clinical signs of canine hepatitis while the control(s) must show severe [60 FR 14359, Mar. 17, 1995] clinical signs of canine hepatitis. If the § 113.203 Feline Panleukopenia Vac- control(s) does not show severe clinical cine, Killed Virus. signs of canine hepatitis, the test is inconclusive and may be repeated: Pro- Feline Panleukopenia Vaccine, Killed vided, That, if any of the vaccinates Virus, shall be prepared from virus- show signs or die of canine hepatitis, bearing cell culture fluids. Only Master the serial is unsatisfactory. Seed which has been established as (3) Potency test for canine adenovirus pure, safe, and immunogenic shall be type 2. Bulk or final container samples used for preparing seeds for vaccine of completed product shall be tested production. All serials of vaccine shall for potency using eight susceptible be prepared from the first through the dogs (five vaccinates and three con- fifth passage from the Master Seed. trols) as the test animals. Blood sam- The Master Seed shall meet the appli- ples drawn from each dog shall be indi- cable requirements prescribed in vidually tested for neutralizing anti- § 113.200. Each serial shall meet the ap- body against canine adenovirus to de- plicable general requirements pre- termine susceptibility. scribed in § 113.200 and the special re- (i) A constant virus-varying serum quirements for safety and potency pro- neutralization test in tissue culture vided in this section. using 50 to 300 TCID50 of virus shall be (a) Safety test. The vaccinates used in used. Dogs shall be considered suscep- the potency test in paragraph (b) of tible if there is no neutralization at a this section shall be observed each day 1:2 final serum dilution. during the postvaccination observation (ii) Vaccination. Each of the five vac- period. If unfavorable reactions occur cinates shall be injected as rec- which are attributable to the vaccine, ommended on the label. If two doses the serial is unsatisfactory. If unfavor- are recommended, the second dose able reactions occur which are not at- shall be administered at the time spec- tributable to the vaccine, the test is in- ified on the label. The dogs shall be ob- conclusive and may be repeated: Pro- served each day for at least 14 days vided, That, if not repeated, the serial after the last inoculation. is unsatisfactory. (iii) Not less than 14 days after the (b) Potency test—serum-neutralization last inoculation, the vaccinates and test. Bulk or final container samples of the controls shall be challenged by ex- completed product shall be tested for posure to a nebulized aerosol of viru- potency using five susceptible cats lent canine adenovirus type 2 furnished (four vaccinates and one control) as the or approved by the Animal and Plant test animals. Blood samples drawn Health Inspection Service and observed from each cat shall be individually each day for 14 days postchallenge. The tested for neutralizing antibody rectal temperature of each animal against feline panleukopenia virus to shall be taken and the presence of res- determine susceptibility. piratory or other clinical signs of ca- (1) A constant virus-varying serum nine adenovirus type 2 noted and re- neutralization test in tissue culture corded each day. using 100 to 300 TCID50 of virus shall be 742

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used. Cats shall be considered suscep- § 113.204 Mink Enteritis Vaccine, tible if there is no neutralization at a Killed Virus. 1:2 final serum dilution. Mink Enteritis Vaccine, Killed Virus, (2) Vaccination. Each of the four vac- shall be prepared from virus-bearing cinates shall be injected as rec- cell culture fluids or tissues obtained ommended on the label. If two doses from mink that have developed mink are recommended, the second dose enteritis following inoculation with shall be given 7 to 10 days after the virulent mink enteritis virus. Each se- first dose and the cats observed each rial shall meet the applicable require- day for 14 to 21 days. ments prescribed in § 113.200 and special (3) Serology. At the end of the requirements prescribed in this sec- postvaccination observation period, a tion. Any serial found unsatisfactory second blood sample shall be obtained by a prescribed test shall not be re- from each of the five cats and the se- leased. rums shall be individually tested for (a) Safety test. Vaccinates used in the neutralizing antibody against feline potency test in paragraph (b) of this panleukopenia virus in the same man- section shall be observed each day ner used to determine susceptibility. prior to challenge. If unfavorable reac- (4) Interpretation of the SN test. (i) If tions attributable to the vaccine occur, the control has not remained the serial is unsatisfactory. If unfavor- seronegative at 1:2, the test is incon- able reactions not attributable to the clusive and may be repeated. vaccine occur, the test shall be de- (ii) If at least 3 of the 4 vaccinates in clared inconclusive and may be re- a valid test have not developed titers peated: Provided, That, if the test is not based upon final serum dilution of at repeated, the serial is unsatisfactory. least 1:8, and the remaining vaccinate (b) Potency test. Bulk or final con- has not developed a titer of at least 1:4, tainer samples of completed product the serial is unsatisfactory except as shall be tested for potency using 10 provided in paragraphs (b)(5) and (6) of mink enteritis susceptible mink (five this section. vaccinates and five controls) as fol- (5) Virus-challenge test. If the results lows: of a valid SN test are unsatisfactory, (1) Vaccination. Each of the five vac- the vaccinates and the control may be cinates shall be injected with one dose challenged with a virulent feline of vaccine as recommended on the label panleukopenia virus furnished by Vet- and observed each day for 14 days. erinary Services and each animal ob- (2) Challenge. At least 2 weeks after served each day for an additional 14 the last inoculation, the five vac- days. cinates and the five controls shall be (6) Interpretation of the virus-challenge challenged with virulent mink enter- test. If the control does not show clin- itis virus and observed each day for 12 ical signs of feline panleukopenia, the days. Fecal material shall be collected test is inconclusive and may be re- on one day between days 4–8 (inclusive) peated except, that if any of the vac- postchallenge from each test animal cinates show such signs, the serial is that remains free of enteric signs and unsatisfactory. Clinical signs of feline tested for the presence of mink enter- panleukopenia shall include a pro- itis virus by cell culture with fluores- nounced leukopenia wherein the white cent antibody examination. blood cell count drops to 4,000 or less (3) Interpretation. A serial is satisfac- per cubic mm or the white cell count tory if at least 80 percent of the vac- drops to less than 25 percent of the nor- cinates remain free of enteric signs and mal level established by an average of do not shed virus in the feces, while at three or more counts taken prior to least 80 percent of the controls develop challenge. clinical signs of mink enteritis or shed virus in the feces. If at least 80 percent [39 FR 27428, July 29, 1974, as amended at 40 of the vaccinates remain free of enteric FR 759, Jan. 3, 1975; 43 FR 41186, Sept. 15, 1978; 43 FR 50162, Oct. 27, 1978; 50 FR 23796, signs and do not shed virus in the feces, June 6, 1985. Redesignated at 55 FR 35562, while less than 80 percent of the con- Aug. 31, 1990, as amended at 56 FR 66786, Dec. trols develop clinical signs of mink en- 26, 1991] teritis or shed virus in the feces, the

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test is considered inconclusive and may main normal, the serial is unsatisfac- be repeated: Provided, That, if at least tory. 80 percent of the vaccinates do not re- [39 FR 27428, July 29, 1974. Redesignated at 55 main well and free of detectable virus FR 35562, Aug. 31, 1990, as amended at 56 FR in the feces, the serial is unsatisfac- 66786, Dec. 26, 1991] tory. § 113.206 Wart Vaccine, Killed Virus. [39 FR 27428, July 29, 1974. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR Wart Vaccine, Killed Virus, shall be 66786, Dec. 26, 1991; 60 FR 14361, Mar. 17, 1995] prepared from virus-bearing epidermal tumors (warts) obtained from a bovine. § 113.205 Newcastle Disease Vaccine, Each serial shall meet the require- Killed Virus. ments prescribed in this section and Newcastle Disease Vaccine (Killed any serial found unsatisfactory by a Virus) shall be prepared from virus- prescribed test shall not be released. bearing tissues or fluids obtained from (a) Purity. Final container samples of embryonated chicken eggs or cell cul- completed product shall meet the re- tures. With the exception of quirements for purity as prescribed in § 113.200(c)(2)(iii), each serial shall meet § 113.200 (c)(1) and (3). the applicable general requirements (b) Safety. Bulk or final container prescribed in § 113.200 and special re- samples of completed product shall quirements prescribed in this section. meet the requirements for safety as A serial found unsatisfactory by a pre- prescribed in §§ 113.33(b) and 113.38. scribed test shall not be released. (c) Formaldehyde content. Bulk or (a) Safety test. The prechallenge part final container samples of completed of the potency test in paragraph (b) of product shall meet the requirements this section shall constitute a safety for formaldehyde content as prescribed test. If unfavorable reactions attrib- in § 113.200(f). utable to the product occur in any of (d) Potency and efficacy. The efficacy the vaccinates, the serial is unsatisfac- of wart vaccine has been demonstrated tory. If unfavorable reactions which to the satisfaction of Veterinary Serv- are not attributable to the product ices as being a valuable biological occur, the test shall be declared incon- product. The inherent nature of the clusive and may be repeated: Provided, product precludes the possible develop- That, if the test is not repeated, the se- ment of serial to serial potency tests rial shall be declared unsatisfactory. and none is required: Provided, That, (b) Potency test. A vaccination-chal- (1) The vaccine shall be a tissue ex- lenge test shall be conducted using sus- tract representing at least 10 percent ceptible chickens 2 to 6 weeks of age at weight to volume suspension of wart time of vaccination, properly identified tissue; and and obtained from the same source and (2) The vaccine shall be limited to hatch. use in the prevention of warts in cat- (1) Ten or more chickens shall be vac- tle. Labeling recommendations shall be cinated as recommended on the label in accordance with § 112.7(i). and kept isolated under observation for [40 FR 14084, Mar. 28, 1975, as amended at 40 at least 14 days. FR 23989, June 4, 1975; 40 FR 30803, July 23, (2) After at least 14 days post-vac- 1975. Redesignated at 55 FR 35562, Aug. 31, cination, the vaccinates and at least 10 1990, as amended at 56 FR 66786, Dec. 26, 1991] unvaccinated chickens that have been kept isolated as controls shall be chal- § 113.207 Encephalomyelitis Vaccine, lenged with a virulent strain of New- Eastern, Western, and Venezuelan, castle disease virus supplied by or ap- Killed Virus. proved by Veterinary Services and the Encephalomyelitis Vaccine, Eastern, vaccinates observed each day for 14 Western, and Venezuelan, Killed Virus, days. shall be prepared from virus-bearing (3) If at least 90 percent of the con- cell culture fluids. Each serial or sub- trols do not show typical signs of New- serial shall meet the requirements pre- castle disease or die, the test is incon- scribed in this section and the general clusive and may be repeated. If at least requirements prescribed in § 113.200, ex- 90 percent of the vaccinates do not re- cept those in § 113.200(d). Any serial or

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subserial found unsatisfactory by a (4) If two or three of the vaccinate prescribed test shall not be released. serum samples show a titer of less than (a) Safety test. Bulk samples of com- 1:40 for the Eastern type fraction, less pleted product from each serial shall be than 1:40 for the Western type fraction, tested for encephalomyelitis virus in- or less than 1:4 for the Venezuelan type activation. fraction, the second stage of the test (1) Each of at least ten 6 to 12 hour may be used for the relevant frac- old chickens shall be injected tion(s): Provided, That, if a fraction is subcutaneously with 0.5 ml of the prod- found acceptable by the first stage of uct and the chickens observed each day the test, the second stage need not be for 10 days. conducted for that fraction. (2) If unfavorable reactions attrib- (5) If the second stage is used and utable to the product occur in the four or more of the vaccinate serum chickens during the observation period, samples show a titer of less than 1:40 the serial is unsatisfactory. If unfavor- for the Eastern type fraction or the able reactions not attributable to the Western type fraction, or less than 1:4 product occur, the test is inconclusive for the Venezuelan type fraction, the and may be repeated: Provided, That, if serial or subserial is unsatisfactory. (6) The results shall be evaluated ac- the test is not repeated, the serial is cording to the following table: unsatisfactory. (b) Potency test. Bulk or final con- CUMULATIVE TOTALS tainer samples of completed product from each serial shall be tested for po- Failures for Failures for Stage Vaccinates acceptance rejection tency in accordance with the two-stage test provided in this paragraph. For 1 ...... 10 ...... 1 or less ...... 4 or more. each fraction contained in the prod- 2 ...... 20 ...... 3 or less ...... Do. uct—Eastern type, Western type, or Venezuelan type—the serological inter- [39 FR 44714, Dec. 27, 1974, as amended at 40 pretations required in this test shall be FR 14084, Mar. 28, 1975; 42 FR 45284, Sept. 9, made independently. A serial or sub- 1977. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66786, Dec. 26, 1991; serial found unsatisfactory for any of 61 FR 67930, Dec. 26, 1996] the fractions shall not be released. (1) For this test, a guinea pig dose § 113.208 Avian Encephalomyelitis shall be one-half the amount rec- Vaccine, Killed Virus. ommended on the label for a horse and Avian Encephalomyelitis Vaccine shall be administered as recommended (Killed Virus) shall be prepared from for a horse. Each of 10 healthy guinea virus-bearing tissues or fluids obtained pigs (vaccinates) shall be injected with from embryonated chicken eggs. Each two guinea pig doses with an interval serial shall meet the general require- of 14 to 21 days between doses. Two ad- ments prescribed in § 113.200 and the re- ditional guinea pigs from the same quirements prescribed in this section. source shall be held as controls. Any serial found unsatisfactory by a (2) Fourteen to 21 days after the sec- prescribed test shall not be released. ond injection, serum samples from (a) Safety tests. (1) The prechallenge each vaccinate and each control shall part of the potency test prescribed in be tested by a plaque reduction, serum paragraph (b) of this section shall con- neutralization test using Vero 76 cells. stitute a safety test. If any of the vac- (3) If the control serum samples show cinates develop clinical signs of disease a titer of 1:4 or greater for any frac- or die due to causes attributable to the tion, the test is inconclusive for that product, the serial is unsatisfactory. fraction and may be repeated: Provided, (2) An inactivation test for viable That, if four or more of the vaccinate avian encephalomyelitis (AE) virus serum samples show a titer of less than shall be conducted on each serial. The 1:40 for the Eastern type fraction, less test shall be conducted using suscep- than 1:40 for the Western type fraction, tible chicken embryos: Provided, That, or less than 1:4 for the Venezuelan type if a non-embryo adapted virus is used fraction, the serial or subserial is un- for vaccine production, the test shall satisfactory without further testing. be conducted in susceptible chickens.

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(i) Chicken Embryo Test. Each of 15 or die from AE infection, the test is in- more AE susceptible 5 or 6 day old em- conclusive and may be repeated. bryos shall be injected in the yolk sac (3) If at least 80 percent of the vac- with 0.2 ml of the vaccine. For a valid cinates do not remain normal, the se- test, at least 80 percent of the embryos rial is unsatisfactory. shall survive for 48 hours post-inocula- [39 FR 12958, Dec. 27, 1974, as amended at 40 tion (PI). Eleven to 13 days PI, all em- FR 41088, Sept. 5, 1975. Redesignated at 55 FR bryos surviving the 48 hour PI period 35562, Aug. 31, 1990, as amended at 56 FR shall be examined for gross lesions of 66786, Dec. 26, 1991] AE; all these embryos shall be normal or the serial is unsatisfactory. Concur- § 113.209 Rabies Vaccine, Killed Virus. rently, five additional embryos from Rabies Vaccine (Killed Virus) shall the same source shall be injected with be prepared from virus-bearing cell cul- live AE virus of the production strain tures or nerve tissues obtained from to serve as positive controls. At least 4 animals that have developed rabies in- of the 5 embryos shall show evidence of fection following injection with rabies AE virus infection during the 11 to 13 virus. Only Master Seed Virus which day PI period or the test shall be con- has been established as pure, safe, and sidered inconclusive and repeated: Pro- immunogenic shall be used for pre- vided, That, if the test is not repeated, paring the production seed virus for the serial shall be declared unsatisfac- vaccine production. All serials of vac- tory. cine shall be prepared from the first (ii) Chicken test. Each of 10 or more through the fifth passage from the AE susceptible 7 day old chickens shall Master Seed Virus. be injected intracerebrally with 0.1 ml (a) The Master Seed Virus shall meet vaccine each. The chickens shall be ob- the applicable requirements prescribed served each day for 28 days. If any in § 113.200 and the requirements pre- chickens show clinical signs of AE, the scribed in this section. serial is unsatisfactory. Concurrently, (1) Each lot of Master Seed Virus 5 additional chickens from the same propagated in tissue or cells of avian source shall be injected intracerebrally origin shall also be tested for extra- with live AE virus of the production neous pathogens by procedures pre- strain to serve as positive controls. At scribed in § 113.37. (2) Each lot of Master Seed Virus least 4 of the 5 controls shall show evi- propagated in primary cell cultures of dence of AE virus infection during the mouse or hamster origin or brain tis- observation period or the test shall be sues of mouse origin shall be tested for inconclusive and may be repeated: Pro- lymphocytic choriomeningitis (LCM) vided, That, if the test is not repeated, virus by the procedure prescribed in the serial shall be unsatisfactory. § 113.42. If LCM virus is detected, the (b) Potency test. Bulk or final con- Master Seed Virus is unsatisfactory. tainer samples of completed product (b) The immunogenicity of vaccine from each serial or one subserial shall prepared with virus at the highest pas- be tested. Ten or more AE-susceptible sage from the Master Seed shall be es- chickens (vaccinates), 4 weeks or older, tablished in each species for which the properly identified and obtained from vaccine is recommended. Tests shall be the same source and hatch, shall be in- conducted in accordance with a projected as recommended on the label. At tocol filed with Animal and Plant least 10 additional AE-susceptible Health Inspection Service before initi- chickens, properly identified and ob- ation of the tests. The vaccine shall be tained from the same source and hatch prepared using methods prescribed in shall be kept in isolation as controls. the Outline of Production. If Rabies (1) At least 28 days post-injection, Vaccine is to be in combination with the vaccinates and the controls shall other fractions, the product to be test- be challenged intramuscularly with a ed shall include all fractions to be test- virulent AE virus and the chickens ob- ed. served each day for 21 days. (1) The preinactivation virus titer (2) If at least 80 percent of the con- must be established as soon as possible trols do not show clinical signs of or after harvest by at least five separate

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virus titrations. A mean relative po- (i) Twenty-five or more animals shall tency value of the vaccine to be used in be used as vaccinates. Each shall be ad- the host animal potency test must be ministered a dose of vaccine at the pro- established by at least five replicate posed minimum potency level and by potency tests conducted in accordance the method specified in the Outline of with the standard NIH test for potency Production. in chapter 37 of ‘‘Laboratory Tech- (ii) Ten or more additional animals niques in Rabies,’’ Fourth Edition shall be held as controls. (1996), edited by F.X. Meslin, M.M. (iii) On or about 30, 90, 180, 270, and Kaplan, and H. Koprowski, World 365 days postvaccination, all test ani- Health Organization, Geneva, Switzer- mals shall be bled and individual serum land (ISBN 92 4 154479 1). The provisions samples tested for neutralizing anti- of chapter 37 of ‘‘Laboratory Tech- bodies to rabies virus. niques in Rabies,’’ Fourth Edition (iv) All surviving test animals shall (1996), are the minimum standards for be challenged intramuscularly with achieving compliance with this section virulent rabies virus furnished or ap- and are incorporated by reference. proved by Animal and Plant Health In- These provisions state that the chal- spection Service 1 year after vaccina- lenge virus standard to be used as the tions, except as provided in (b)(4) of challenge in the NIH test and the ref- this section. The challenged animals erence vaccine for the test are avail- shall be observed each day for 90 days able from the national control author- as prescribed in § 113.5(b). The brain of ity. In the United States, that author- each test animal that dies following ity is the Animal and Plant Health In- challenges shall be examined for rabies spection Service’s Center for Veteri- by the fluorescent antibody test or nary Biologics Laboratory, located at other method acceptable to Animal and 1920 Dayton Avenue, P.O. Box 844, Plant Health Inspection Service. Ames, IA 50010; phone (515) 337-6100; fax (515) 337-6120. This incorporation by ref- (v) Requirements for acceptance in erence was approved by the Director of challenge tests shall be death due to the Federal Register in accordance rabies in at least 80 percent of the con- with 5 U.S.C. 552(a) and 1 CFR part 51. trols while at least 22 of 25 or 26 of 30 Copies may be obtained from the World or a statistically equivalent number of Health Organization Publications Cen- the vaccinates remain well for a period ter USA, 49 Sheridan Avenue, Albany, of 90 days. NY 12210. Copies may be inspected at (4) An alternative to challenging all the Animal and Plant Health Inspec- surviving test animals in accordance tion Service, Center for Veterinary with paragraph (b)(3)(iv) of this section Biologics, Policy, Evaluation, and Li- may be used when the test animals are censing, 1920 Dayton Avenue, P.O. Box of species other than carnivores. Vac- 844, Ames, IA 50010, or at the National cinates shall be challenged at 1 year Archives and Records Administration postvaccination. These shall include (NARA). For information on the avail- five vaccinates with the lowest SN ability of this material at NARA, call titers at the 270th-day bleeding, five 202–741–6030, or go to: http:// vaccinates with the lowest SN titers at www.archives.gov/federallregister/ the 365th-day bleeding, and all vac- codeloflfederallregulations/ cinates with SN titers below 1:10 by the ibrllocations.html. mouse SN test or below 1:16 by the (2) The dose of vaccine to be used in rapid-fluorescent-focus-inhibition test the immunogenicity test shall be no at any bleeding. At least five SN-nega- more than the amount which, on the tive controls of each species shall be basis of The NIH Test For Potency, has challenged at the same time as the been diluted to the proposed minimum vaccinates. All SN titers shall be acceptable potency value. 1 titrated to an endpoint. All of the chal- (3) Test animals shall be uniform and lenged vaccinates must remain well for have no neutralizing antibodies to ra- a period of 90 days, and at least 80 per- bies as determined by serum-neutral- cent of the controls must die of rabies ization (SN) tests. for a satisfactory test without further

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challenge. If one or more of the vac- bies virus. If live rabies virus is con- cinates die from rabies, all the remain- firmed, the serial is unsatisfactory un- ing vaccines, regardless of titer, along less reprocessed in accordance with with the five controls shall be chal- § 114.18. lenged. The cumulative results from (ii) A test for safety in three young the two challenges shall be evaluated seronegative animals of the most sus- for acceptance as specified in para- ceptible species for which the vaccine graph (b)(3)(v) of this section. is recommended shall be conducted. (5) An Outline of Production change Each shall in injected intramuscularly shall be made before authority for use with one recommended dose of vaccine. a new lot of Master Seed Virus shall be If unfavorable reactions attributable to granted by Animal and Plant Health the product occur during a 28 day ob- Inspection Service. servation period, the serial is unsatis- (c) If more than 1 year duration of factory. immunity is to be claimed, a duration (3) Potency test. Bulk or final con- of immunity test for the additional tainer samples of completed product time shall be conducted and inter- from each serial must be tested for po- preted as prescribed in paragraph (b) of tency by tests conducted in accordance this section for the 1 year test. The with the standard NIH test for potency test animals shall be monitored sero- in Chapter 37 of ‘‘Laboratory Tech- logically at least every 180 days. The niques in Rabies,’’ Fourth Edition time of challenge may be adjusted ac- (1996), which is incorporated by ref- cordingly. erence at paragraph (b)(1) of this sec- (d) Test requirements for release: tion. The relative potency of each se- Each serial and each subserial shall rial must be at least equal to that used meet the general requirements pre- in an approved host animal scribed in § 113.200 and special require- immunogenicity test. ments in this paragraph. (1) Purity test. Primary cell cultures [39 FR 44715, Dec. 27, 1974, as amended at 42 FR 6794, Feb. 4, 1977; 43 FR 49528, Oct. 24, 1978; of hamster origin or brain tissues of 50 FR 20090, May 14, 1985. Redesignated at 55 mouse origin used in vaccine produc- FR 35562, Aug. 31, 1990; 56 FR 66784, 66786, tion shall be tested for LCM virus as Dec. 26, 1991; 61 FR 31823, June 21, 1996; 64 FR prescribed in § 113.42. Hamster origin 45420, Aug. 20, 1999; 69 FR 18803, Apr. 9, 2004; cells shall be disrupted and undiluted 75 FR 20773, Apr. 21, 2010] cell fluids from each lot shall be tested. Where mouse brains are used in produc- § 113.210 Feline Calicivirus Vaccine, tion, at least five mice which have not Killed Virus. been injected with rabies virus shall be Feline Calicivirus Vaccine, Killed sacrificed and a 10 percent suspension Virus, shall be prepared from virus- of brain material shall be prepared and bearing cell culture fluids. Only Master tested. Seed which has been established as (2) Safety tests. Bulk samples from pure, safe, and immunogenic shall be each serial shall be tested for virus in- used for preparing seeds for vaccine activation and safety as follows: production. All serials of vaccine shall (i) At the end of the inactivation pe- be prepared from the first through the riod, each of 20 12 to 16 gram mice shall fifth passage from the Master Seed. be injected intracerebrally with 0.03 ml (a) The Master Seed shall meet the and two rabbits shall be injected into applicable general requirements pre- each cerebral hemisphere with 0.25 ml scribed in § 113.200. and observed each day for 21 days. The (b) The Master Seed shall be tested brains of animals dying between the for chlamydial agents as prescribed in fourth and 21st day post-injection shall § 113.43. be checked for rabies virus. Material (c) The immunogenicity of vaccine from each brain recovered shall be in- prepared from the Master Seed in ac- jected into each of five mice and the cordance with the Outline of Produc- mice observed each day for 14 days. The tion shall be established by a method fluorescent antibody test or serum neu- acceptable to Animal and Plant Health tralization test shall be used to con- Inspection Service. Vaccine used for firm the presence or absence or live ra- this test shall be at the highest passage

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from the Master Seed and prepared at signs, particularly lesions on the oral the minimum preinactivation titer mucosa, noted and recorded each day. specified in the Outline of Production. (iv) If three of three controls do not (d) Test requirements for release. Each show clinical signs of feline calicivirus serial and subserial shall meet the ap- infection other than fever, the test is plicable general requirements pre- inconclusive and may be repeated. scribed in § 113.200 and the special re- (v) If a significant difference in clin- quirements provided in this paragraph. ical signs cannot be demonstrated be- Any serial or subserial found unsatis- tween vaccinates and controls using a factory by a prescribed test shall not scoring system approved by Animal be released. and Plant Health Inspection Service (1) Safety. Vaccinates used in the potency test in paragraph (d)(2) of this and prescribed in the Outline of Pro- section shall be observed each day dur- duction, the serial is unsatisfactory. ing the prechallenge period. If unfavor- [50 FR 433, Jan. 4, 1985. Redesignated at 55 able reactions occur, including oral le- FR 35562, Aug. 31, 1990, as amended at 56 FR sions, which are attributable to the 66784, 66786, Dec. 26, 1991] vaccine, the serial is unsatisfactory. If unfavorable reactions occur which are § 113.211 Feline Rhinotracheitis Vac- not attributable to the vaccine, the cine, Killed Virus. test is inconclusive and may be re- Feline Rhinotracheitis Vaccine, peated. If the test is not repeated, the Killed Virus, shall be prepared from serial is unsatisfactory. virus-bearing cell culture fluids. Only (2) Potency. Bulk or final container Master Seed which has been estab- samples of completed product shall be lished as pure, safe, and immunogenic treated for potency as follows: shall be used for preparing seeds for (i) Eight feline calicivirus susceptible vaccine production. All serials of vac- cats (five vaccinates and three con- cine shall be prepared from the first trols) shall be used as test animals. Throat and nasal swabs shall be col- through the fifth passage from the lected from each cat and individually Master Seed. tested on susceptible cell cultures for (a) The Master Seed shall meet the the presence of feline calicivirus. Blood applicable general requirements pre- samples shall be drawn and individual scribed in § 113.200. serum samples tested for neutralizing (b) The Master Seed shall be tested antibody. The cats shall be considered for chlamydial agents as prescribed in suitable for use if all swabs are nega- § 113.43. tive for virus isolation and all serums (c) The immunogenicity of vaccine are negative for calicivirus antibody at prepared from the Master Seed in ac- the 1:2 final dilution in a 50 percent cordance with the Outline of Produc- plaque reduction test or other test of tion shall be established by a method equal sensitivity. acceptable to Animal and Plant Health (ii) The five cats used as vaccinates Inspection Service. Vaccine used for shall be administered one dose of vac- this test shall be at the highest passage cine by the method recommended on from the Master Seed and prepared at the label. If two doses are rec- the minimum preinactivation titer ommended, the second dose shall be specified in the Outline of Production. given after the interval recommended on the label. (d) Test requirements for release. Each (iii) Fourteen or more days after the serial and subserial shall meet the ap- final dose of vaccine, the vaccinates plicable general requirements pre- and controls shall each be challenged scribed in § 113.200 and the special re- intranasally with virulent feline quirements provided in this paragraph. calicivirus furnished or approved by Any serial or subserial found unsatis- Animal and Plant Health Inspection factory by a prescribed test shall not Service and observed each day for 14 be released. days postchallenge. The rectal tem- (1) Safety test. Vaccinates used in the perature of each animal shall be taken potency test in paragraphs (d)(2) of this and the presence or absence of clinical

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section shall be observed each day dur- and prescribed in the Outline of Pro- ing the prechallenge period. If unfavor- duction, the serial is unsatisfactory. able reactions occur which are attrib- [50 FR 433, Jan. 4, 1985. Redesignated at 55 utable to the vaccine, the serial is un- FR 35562, Aug. 31, 1990, as amended at 56 FR satisfactory. If unfavorable reactions 66784, 66786, Dec. 26, 1991] occur which are not attributable to the vaccine, the test is inconclusive and § 113.212 Bursal Disease Vaccine, may be repeated. If the test is not re- Killed Virus. peated, the serial is unsatisfactory. Bursal Disease Vaccine, Killed Virus, (2) Potency test. Bulk or final con- shall be prepared from virus-bearing tainer samples of completed product cell culture fluids or embryonated shall be tested for potency as follows: chicken eggs. Only Master Seed which (i) Eight feline rhinotracheitis sus- has been established as pure, safe, and ceptible cats (five vaccinates and three immunogenic shall be used for pre- controls) shall be used as test animals. paring seeds for vaccine production. All Throat and nasal swabs shall be col- serials shall be prepared from the first lected from each cat and individually through the fifth passage from the tested on susceptible cell cultures for Master Seed. the presence of feline rhinotracheitis (a) The Master Seed shall meet the virus. Blood samples shall be drawn applicable requirements prescribed in and individual serum samples tested § 113.200. for neutralizing antibody. The cats (b) Each lot of Master Seed shall be shall be considered suitable for use if tested for pathogens by the chicken all swabs are negative for virus isola- embryo inoculation test prescribed in tion and all serums are negative for § 113.37, except that, if the test is incon- rhinotracheitis virus antibody at the clusive because of a vaccine virus over- 1:2 final dilution in a 50 percent plaque ride, the chicken inoculation test pre- reduction test or other test of equal scribed in § 113.36 may be conducted and sensitivity. the virus judged accordingly. (c) The immunogenicity of vaccine (ii) The five cats used as vaccinates prepared in accordance with the Out- shall be administered one dose of vac- line of Production shall be established cine by the method recommended on by a method acceptable to Animal and the label. If two doses are rec- Plant Health Inspection Service. Vac- ommended, the second dose shall be cine used for this test shall be at the given after the interval recommended highest passage from the Master Seed on the label. and prepared at the minimum (iii) Fourteen or more days after the preinactivation titer specified in the final dose of vaccine, the vaccinates Outline of Production. The test shall and controls shall each be challenged establish that the vaccine, when used intranasally with virulent feline as recommended on the label, is capa- rhinotracheitis virus furnished or ap- ble of inducing an immune response in proved by Animal and Plant Health In- dams of sufficient magnitude to pro- spection Service and observed each day vide significant protection to offspring. for 14 days postchallenge. The rectal (d) Test requirements for release. Each temperature of each animal shall be serial and subserial shall meet the ap- taken and the presence or absence of plicable general requirements pre- clinical signs noted and recorded each scribed in § 113.200 and the special re- day. quirements in this paragraph. Any se- (iv) If three of three controls do not rial or subserial found unsatisfactory show clinical signs of feline by a prescribed test shall not be re- rhinotracheitis virus infection other leased. than fever, the test is inconclusive and (1) Safety. Vaccinates used in the po- may be repeated. tency test in paragraph (d)(2) of this (v) If a significant difference in clin- section shall be observed each day dur- ical signs cannot be demonstrated being the prechallenge period. If unfavor- tween vaccinates and controls using a able reactions attributable to the vac- scoring system approved by Animal cine occur, the serial is unsatisfactory. and Plant Health Inspection Service If unfavorable reactions which are not

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attributable to the vaccine occur, the cinates and 10 controls by eyedrop with test is inconclusive and may be re- a virulent infectious bursal disease peated. If the test is not repeated, the virus furnished or approved by Animal serial is unsatisfactory. and Plant Health Inspection Service. (2) Potency. Bulk or final container (iv) Postchallenge period. Four days samples of completed product from postchallenge, necropsy all chickens each serial shall be tested for potency and examine each for gross lesions of using the two-stage potency test pro- bursal disease. For purposes of this vided in this paragraph. test, gross lesions shall include (i) Vaccinates. Inject each of 21 susceptible chickens 14 to 28 days of age, peribursal edema and/or edema and/or properly identified and obtained from macroscopic hemorrhage in the bursal the same source and hatch, with one tissue. Vaccinated chickens showing dose of vaccine by the route rec- gross lesions shall be counted as fail- ommended on the label and observe for ures. If at least 80 percent of the con- at least 21 days. trols do not have gross lesions of bursal (ii) Controls. Retain at least 10 addi- disease in a stage of the test, that tional chickens from the same source stage is considered inconclusive and and hatch as unvaccinated controls. may be repeated. In a valid test, the re- (iii) Challenge. Twenty-one to 28 days sults shall be evaluated according to postvaccination, challenge 20 vac- the following table:

Cumu- Cumulative total number of Number lative failures for— Stage of vac- number cinates of vac- Satisfactory Unsatisfac- cinates serial tory serial

1 ...... 20 20 3 or less ...... 6 or more. 2 ...... 20 40 8 or less ...... 9 or more.

(v) If four or five vaccinates show le- (b) The immunogenicity of vaccine sions of bursal disease in the first prepared from the Master Seed in ac- stage, the second stage may be con- cordance with the Outline of Produc- ducted in a manner identical to the tion shall be established by a method first stage. If the second stage is not acceptable to Animal and Plant Health conducted, the serial is unsatisfactory. Inspection Service. Vaccine used for (vi) If the second stage is used, each this test shall be at the highest passage serial shall be evaluated according to from the Master Seed and at the min- the second part of the table on the imum preinactivation titer provided in basis of cumulative results. the Outline of Production. [50 FR 434, Jan. 4, 1985. Redesignated at 55 (c) Test requirements for release. Each FR 35562, Aug. 31, 1990, as amended at 56 FR serial and subserial shall meet the ap- 66784, 66786, Dec. 26, 1991] plicable general requirements prescribed in § 113.200 and the special re- § 113.213 Pseudorabies Vaccine, Killed quirements provided in this paragraph. Virus. Any serial or subserial found unsatis- Pseudorabies Vaccine, Killed Virus, factory by a prescribed test shall not shall be prepared from virus-bearing be released. cell culture fluids. Only Master Seed (1) Safety. Vaccinates used in the po- which has been established as pure, tency test in paragraph (c)(2) of this safe, and immunogenic shall be used section shall be observed each day dur- for preparing seeds for vaccine producing the prechallenge period. If unfavor- tion. All serials of vaccine shall be pre- able reactions occur, including neuro- pared from the first through the fifth logical signs, which are attributable to passage from the Master Seed. the vaccine, the serial is unsatisfac- (a) The Master Seed shall meet the tory. If unfavorable reactions occur applicable general requirements pre- which are not attributable to the vac- scribed in § 113.200. cine, the test is inconclusive and may

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be repeated. If the test is not repeated, clinical signs or die, the serial is unsat- the serial is unsatisfactory. isfactory. (2) Potency. Bulk or final container [50 FR 434, Jan. 4, 1985. Redesignated at 55 samples of completed product shall be FR 35562, Aug. 31, 1990, as amended at 56 FR tested for potency as follows: 66784, 66786, Dec. 26, 1991] (i) Ten pseudorabies susceptible pigs (five vaccinates and five controls) shall § 113.214 Parvovirus Vaccine, Killed be used as test animals. The animals Virus (Canine). shall be at the minimal age rec- Parvovirus Vaccine, Killed Virus, ommended for vaccination. Blood sam- recommended for use in dogs, shall be ples shall be drawn and individual prepared from virus-bearing cell cul- serum samples inactivated and tested ture fluids. Only Master Seed which for neutralizing antibody. has been established as pure, safe, and (ii) A constant virus-varying serum immunogenic shall be used for vaccine neutralization test in cell culture using production. All serials of vaccine shall be prepared from the first through the 50 to 300 TCID50 of virus shall be used. Pigs shall be considered susceptible if fifth passage from the Master Seed. there is no neutralization at 1:2 final (a) The Master Seed shall meet the applicable general requirements pre- serum dilution. Other tests of equal scribed in § 113.200. sensitivity acceptable to Animal and (b) The immunogenicity of vaccine Plant Health Inspection Service may prepared in accordance with the Out- be used. line of Production shall be established (iii) The five pigs used as vaccinates as follows: shall be administered one dose of vac- (1) Twenty-five parvovirus suscep- cine as recommended on the label. If tible dogs (20 vaccinates and 5 controls) two doses are recommended, the second shall be used as test animals. Blood dose shall be given after the interval samples drawn from each dog shall be recommended on the label. individually tested for neutralizing (iv) Fourteen days or more after vac- antibody against canine parvovirus to cination, blood samples shall be drawn determine susceptibility. and individual serum samples inac- A constant virus-varying serum neu- tivated and tested for pseudorabies tralization test in cell culture using 50 virus neutralizing antibody by the to 300 TCID50 of virus shall be used. method used to determine suscepti- Dogs shall be considered susceptible if bility. there is no neutralization at a 1:2 final (v) Test interpretation. If the controls serum dilution. Other tests of equal have not remained seronegative at 1:2, sensitivity acceptable to Animal and the test is inconclusive and may be re- Plant Health Inspection Service may peated. If at least four of the five vac- be used. cinates in a valid test have not devel- (2) A viral hemagglutination test or oped titers of at least 1:8, and the re- another test acceptable to Animal and maining vaccinate has not developed a Plant Health Inspection Service shall titer of at least 1:4, the serial is unsat- be used to measure the antigenic con- isfactory, except as provided in para- tent of vaccine produced at the highest graph (c)(2)(vi) of this section. passage from the Master Seed before (vi) Virus challenge test. If the results the immunogenicity test is conducted. of a valid serum neutralization test are The 20 dogs used as vaccinates shall be unsatisfactory, the vaccinates and con- injected with a predetermined dose of trols may be challenged with virulent vaccine by the method recommended pseudorabies virus furnished or ap- on the label. To confirm the dosage cal- proved by Animal and Plant Health In- culations, five replicate tests shall be spection Service. The animals shall be conducted on a sample of the vaccine observed each day for 14 days used. If two doses are used, five rep- postchallenge. If four of five controls licate confirming tests shall be con- do not develop central nervous system ducted on each dose. signs or die, the test is inconclusive (3) Fourteen days or more after the and may be repeated. In a valid test, if final dose of vaccine, the vaccinates two or more of the vaccinates develop and the controls shall be challenged

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with virulent canine parvovirus fur- as provided in subparagraph (4)(v) of nished or approved by Animal and this section. Plant Health Inspection Service and (v) If the results of a valid SN test the dogs observed each day for 14 days. are unsatisfactory, the vaccinates and Rectal temperature, blood lymphocyte the control may be challenged as pro- count, and feces for viral detection vided in paragraph (b)(3) of this sec- shall be taken from each dog each day tion. If at least three of the four cri- for at least 10 days postchallenge and teria of infection are not shown, the the presence or absence of clinical test is inconclusive and may be re- signs noted and recorded each day. peated, except that if any of the vac- (i) The immunogenicity of the vaccinates show more than one criterion cine shall be evaluated on the fol- of infection, the Master Seed is unsat- lowing criteria of infection: tempera- isfactory. ture ≥103.4 °F; lymphopenia of ≥50 per- (5) An Outline of Production change cent of prechallenge normal; clinical shall be made before authority for use signs such as diarrhea, mucus in feces, of a new lot of Master Seed shall be or blood in feces; and viral granted by Animal and Plant Health hemagglutinins at a level of ≥1:64 in a Inspection Service. 1:5 dilution of feces or a test of equal (c) Test requirements for release. Each sensitivity. If at least 80 percent of the serial and subserial shall meet the re- controls do not show at least three of quirements prescribed in § 113.200 and the four criteria of infection during the in this paragraph. Any serial or sub- observation period, the test is incon- serial found unsatisfactory by a pre- clusive and may be repeated. scribed test shall not be released. (1) Potency. Bulk or final container (ii) If at least 19 of the 20 vaccinates samples of completed product shall be do not survive the observation period tested for antigenic content using the without showing any more than one method used in paragraph (b)(2) of this criterion of infection described in sub- section. To be eligible for release, each paragraph (3)(i), of this section, the serial and each subserial shall have an Master Seed is unsatisfactory. antigenic content sufficiently greater (4) The Master Seed shall be retested than that used in the immunogenicity for immunogenicity in 3 years unless test to assure that, when tested at any use of the lot previously tested is dis- time within the expiration period, each continued. Only five susceptible dogs serial and subserial shall have an anti- (four vaccinates and one control) need genic content equal to the amount used to be used in the retest. Susceptibility in such immunogenicity test. shall be determined in the manner pro- (2) Virus identity. Bulk or final con- vided in paragraph (b)(1) of this sec- tainer samples shall be tested for virus tion. identity by conducting a (i) Each vaccinate shall be injected hemagglutination test using duplicate with a predetermined quantity of vac- samples and pretreating one with spe- cine virus as provided in paragraph cific canine parvovirus antibody. If (b)(2) of this section. there is not at least an eightfold reduc- (ii) Fourteen to 21 days after the last tion in hemagglutinating activity, the vaccination, a second serum sample hemagglutination is considered to be shall be drawn from each dog and test- nonspecific and the serial is unsatisfac- ed for neutralizing antibody to canine tory. parvovirus in the same manner used to [50 FR 435, Jan. 4, 1985. Redesignated at 55 determine susceptibility. FR 35562, Aug. 31, 1990, as amended at 56 FR (iii) If the control has not remained 66784, 66786, Dec. 26, 1991] seronegative at 1:2, the test is inconclusive and may be repeated. § 113.215 Bovine Virus Diarrhea Vac- (iv) If three of the four vaccinates in cine, Killed Virus. a valid test do not develop titers based Bovine Virus Diarrhea Vaccine, upon final serum dilution of at least Killed Virus, shall be prepared from 1:16, and the remaining vaccinate does virus-bearing cell culture fluids. Only not develop a titer of at least 1:8, the Master Seed virus which has been es- Master Seed is unsatisfactory, except tablished as pure, safe, and

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immunogenic shall be used for pre- mal and Plant Health Inspection Serv- paring seed cultures for vaccine pro- ice may be used. duction. All serials of vaccine shall be (iii) The five calves used as vac- prepared from the first through the cinates shall be administered one dose fifth passage from the Master Seed. of vaccine as recommended on the (a) The Master Seed shall meet the label. If two doses are recommended, applicable general requirements pre- the second dose shall be given accord- scribed in § 113.200 and the require- ing to the interval recommended on ments of this section. the label. (b) The immunogenicity of vaccine (iv) Fourteen days or more after the prepared from the Master Seed in ac- last vaccination, blood samples shall cordance with the Outline of Produc- be drawn and the individual serum tion shall be established by a method samples inactivated and tested for bo- acceptable to the Animal and Plant vine virus diarrhea virus neutralizing Health Inspection Service. Vaccine antibody by the same method used to used for this test shall be at the high- determine susceptibility. est passage from the Master Seed and (v) If the controls at the minimum preinactivation titer Test interpretation. provided in the Outline of Production. have not remained seronegative at 1:2, (c) Test requirements for release. Each the test is a No Test (NT) and may be serial and subserial shall meet the ap- repeated. If at least four of the five plicable general requirements pre- vaccinates in a valid test have not described in § 113.200 and the special re- veloped 50 percent endpoint titers of 1:8 quirements provided in this paragraph. or greater, the serial is unsatisfactory, Any serial or subserial found unsatis- except as provided in paragraph factory by a prescribed test shall not (c)(2)(vi) of this section. be released. (vi) Virus Challenge Test. If the results (1) Safety. Vaccinates used in the po- of a valid serum neutralization test are tency test in paragraph (c)(2) of this unsatisfactory, the vaccinates and con- section shall be observed each day dur- trols may be challenged with virulent ing the prechallenge period. If unfavor- bovine virus diarrhea virus furnished able reactions occur, including res- or approved by the Animal and Plant piratory signs, which are attributable Health Inspection Service. The animals to the vaccine, the serial is unsatisfac- shall be observed for 14 days post-chal- tory. If unfavorable reactions occur lenge. If two of the three control calves which are not attributable to the vac- do not show a temperature rise to 104.5 cine, the test is inconclusive and may °F and develop respiratory or clinical be repeated one time. If results of the signs of bovine virus diarrhea, the test second test are not satisfactory, or if is inconclusive and may be repeated the test is not repeated, the serial is one time. If two or more vaccinates unsatisfactory. show a temperature of 104.0 °F for 2 or (2) Potency. Bulk or final container more days and develop respiratory or samples of completed product shall be clinical or other signs, the serial is un- tested for potency using the method satisfactory. described in this paragraph. (vii) The prevaccination and (i) Eight bovine virus diarrhea sus- postvaccination sera from a satisfac- ceptible calves (five vaccinates and tory potency test shall be submitted to three controls) shall be used as test the National Veterinary Services Lab- animals. Individual serum samples oratories for confirmatory testing. shall be collected, inactivated, and individually tested for neutralizing anti- [55 FR 35562, Aug. 31, 1990] body. (ii) A constant virus decreasing § 113.216 Bovine Rhinotracheitis Vac- serum neutralization test in cell cul- cine, Killed Virus. ture using 50–300 TCID50 of virus shall Infectious Bovine Rhinotracheitis be used. Calves shall be considered sus- Vaccine, Killed Virus, shall be prepared ceptible if there is no neutralization at from virus-bearing cell culture fluids. 1:2 final serum dilution. Other tests of Only Master Seed virus which has been equal sensitivity approved by the Ani- established as pure, safe, and

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immunogenic shall be used for pre- (iii) The five calves used as vac- paring seed cultures for vaccine pro- cinates shall be administered one dose duction. All serials of vaccine shall be of vaccine as recommended on the prepared from the first through the label. If two doses are recommended, fifth passage from the Master Seed. the second dose shall be given accord- (a) The Master Seed shall meet the ing to the interval recommended on applicable general requirements pre- the label. scribed in § 113.200 and the require- (iv) Fourteen or more days after the ments of this section. last vaccination, blood samples shall (b) The immunogenicity of vaccine be drawn and the individual serum prepared in accordance with the Out- samples inactivated and tested for in- line of Production shall be established fectious bovine rhinotracheitis virus by a method acceptable to the Animal neutralizing antibody by the same and Plant Health Inspection Service. method used to determine suscepti- Vaccine used for this test shall be at bility. the highest passage from the Master (v) Test interpretation. If the three Seed and at the minimum controls have not remained preinactivation titer provided in the seronegative at 1:2, the test is a No Outline of Production. Test (NT) and may be repeated. If at (c) Test requirements for release. Each least four of the five vaccinates in a serial and subserial shall meet the re- valid test have not developed 50 per- quirements prescribed in § 113.200 and cent endpoint titers of 1:8, the serial is the special requirements provided in unsatisfactory, except as provided in this paragraph. Any serial or subserial paragraph (c)(2)(vi) of this section. found unsatisfactory by a prescribed (vi) Virus Challenge Test. If the results test shall not be released. of a valid serum neutralization test are (1) Safety. Vaccinates used in the po- unsatisfactory, the vaccinates and con- tency test in paragraph (c)(2) of this trols may be challenged with virulent section shall be observed each day dur- infectious bovine rhinotracheitis virus ing the prechallenge period. If unfavor- furnished or approved by the Animal able reactions occur, which are attrib- and Plant Health Inspection Service. utable to the vaccine, the serial is un- The animals shall be observed each day satisfactory. If unfavorable reactions for 14 days post-challenge. If two of the occur which are not attributable to the three control calves do not show a tem- vaccine, the test is inconclusive and perature rise to 104.5 °F and develop may be repeated one time. If the re- respiratory or other clinical signs of sults of the second test are not satis- infectious bovine rhinotracheitis, the factory, or if the test is not repeated, test is a No Test (NT) and may be re- the serial is unsatisfactory. peated one time. If more than one of (2) Potency. Bulk or final container the vaccinates shows a temperature of samples of completed product shall be 104.0 °F for 2 or more days or if more tested for potency using the method than one of the vaccinates develops described in this paragraph. respiratory or clinical or other signs, (i) Eight infectious bovine the serial is unsatisfactory. rhinotracheitis susceptible calves (five (vii) The prevaccination and vaccinates, three controls) shall be postvaccination sera from a satisfac- used as test animals. Individual serum tory potency test shall be submitted to samples shall be collected, inactivated, the National Veterinary Services Lab- and individually tested for neutralizing oratories for testing by the Animal and antibody. Plant Health Inspection Service. (ii) A constant virus decreasing [55 FR 35562, Aug. 31, 1990, as amended at 56 serum neutralization test in cell cul- FR 66786, Dec. 26, 1991] ture using 50–300 TCID50 of virus shall be used. Calves shall be considered sus- LIVE VIRUS VACCINES ceptible if there is no neutralization at 1:2 final serum dilution. Other tests of § 113.300 General requirements for live equal sensitivity acceptable to the Ani- virus vaccines. mal and Plant Health Inspection Serv- When prescribed in an applicable ice may be used. Standard Requirement or in the filed

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Outline of Production, a live virus vac- jugated specific antiserum. Fluores- cine shall meet the applicable require- cence typical of the virus concerned ments in this section. shall be demonstrated in the inocu- (a) Purity tests—(1) Bacteria and fungi. lated cells. The control cells shall re- Final container samples of completed main free of such fluorescence. product and comparable samples of (2) Serum neutralization test. The each lot of Master Seed Virus shall be serum neutralization test shall be con- tested for bacteria and fungi in accord- ducted using the constant serum-de- ance with the test provided in § 113.27. creasing virus method with specific (2) Mycoplasma. Final container sam- antiserum. For positive identification, ples of completed product and com- at least 100 ID50 of vaccine virus shall parable samples of each lot of Master be neutralized by the antiserum. Seed Virus shall be tested for myco- (d) Cell Culture Requirements. If cell plasma in accordance with the test pro- cultures are used in the preparation of vided in § 113.28. Master Seed Virus or of the vaccine, (3) Avian Origin Vaccine. Samples of primary cells shall meet the require- each lot of Master Seed Virus and bulk ments prescribed in § 113.51, cell lines pooled material or final container sam- shall meet the requirements prescribed ples from each serial shall also be test- in § 113.52, and ingredients of animal or- ed for: igin shall meet the applicable require- (i) Salmonella contamination as pre- ments in § 113.53. scribed in § 113.30; and (e) Moisture content. (1) The max- (ii) Lymphoid leukosis virus con- imum moisture content in desiccated tamination as prescribed in § 113.31; and vaccines must be stated in the filed (iii) Hemagglutinating viruses as pre- Outline of Production. scribed in § 113.34. (2) Final container samples of com- (4) Extraneous viruses. Each lot of pleted product from each serial or sub- Master Seed Virus used to prepare live serial must be tested for moisture con- virus vaccine recommended for animals tent in accordance with the test pre- other than poultry shall meet the re- scribed in § 113.29. quirements for extraneous viruses as [39 FR 27430, July 29, 1974, as amended at 43 prescribed in § 113.55 FR 49528, Oct. 24, 1978; 50 FR 1042, Jan. 9, 1985; (b) Safety tests. Samples of each lot of 54 FR 19352, May 5, 1989. Redesignated at 55 Master Seed Virus and final container FR 35562, Aug. 31, 1990; 60 FR 24549, May 9, samples of completed product from 1995; 68 FR 57608, Oct. 6, 2003] each serial or first subserial of live virus vaccine recommended for animals § 113.301 Ovine Ecthyma Vaccine. other than poultry shall be tested for Ovine Ecthyma Vaccine shall be pre- safety in at least one species for which pared from tissue culture fluids or the vaccine is intended using methods virus-bearing tissues obtained from prescribed in §§ 113.39, 113.40, 113.41, sheep that have developed ovine 113.44, and 113.45 or in a filed Outline of ecthyma following inoculation with Production. The mouse safety test pre- virulent ovine ecthyma virus. Ovine scribed in § 113.33(a) shall also be con- Ecthyma Vaccine is exempt from the ducted unless the virus or agent in the requirements prescribed in §§ 113.27 and vaccine is inherently lethal for mice. 113.300(a), (b), and (c). Each serial shall (c) Virus identity test. At least one of meet the moisture requirements in the virus identity tests provided in this § 113.300(e) and the special requirements paragraph or a suitable identity test prescribed in this section. Any serial prescribed in the filed Outline of Pro- found unsatisfactory by a prescribed duction shall be conducted on the Mas- test shall not be released. ter Seed Virus and final container sam- (a) Safety tests. (1) Bulk or final con- ples from each serial or first subserial tainer samples of completed product of biological product. from each serial shall be tested for (1) Fluorescent antibody test. The fluo- safety as prescribed in § 113.38. rescent antibody test shall be con- (2) The prechallenge period of the po- ducted using virus inoculated cells and tency test shall constitute a safety uninoculated control cells. Cells shall test. If unfavorable reactions attrib- be stained with fluorochrome con- utable to the vaccine occur in either of

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the vaccinates during the observation days. If undesirable reactions occur in period, the serial is unsatisfactory. either test animal, the lot of Master (b) Potency test. Final container sam- Seed Virus is unsatisfactory. ples of completed product from each se- (2) Master Seed Virus propagated in rial and each subserial shall be tested chicken embryos shall be tested for for potency using susceptible lambs. pathogens by the chicken embryo test The vaccine shall be prepared as rec- prescribed in § 113.37 except lesions typ- ommended for use on the label. ical of distemper virus may be dis- (1) Each of two lambs (vaccinates) regarded. If found unsatisfactory, the shall be vaccinated by application of Master Seed Virus shall not be used. the vaccine to a scarified area on the (c) Each lot of Master Seed Virus medial surface of the thigh and ob- used for vaccine production shall be served each day for 14 days. tested for immunogenicity. The se- (2) The immunity of the two vac- lected virus dose from the lot of Master cinates and one or more unvaccinated Seed Virus shall be established as fol- lambs (controls) shall be challenged in lows: the same manner as for vaccination, (1) At least 25 distemper susceptible using the opposite thigh. mink shall be used as test animals. (3) If typical signs of ovine ecthyma, Blood samples shall be drawn from such as hyperemia, vesicles, and these animals and individual serum pustules do not develop on the controls samples tested. The mink shall be con- during the first 2 weeks following chal- sidered susceptible if the results are lenge and persist for approximately 30 negative at a 1:2 final serum dilution in days, the test is inconclusive and may a varying serum-constant virus neu- be repeated. tralization test with less than 500 ID50 (4) If the vaccinates do not show a of canine distemper virus. Other means typical immune reaction, the serial is of insuring susceptibility may be used unsatisfactory: Provided, That, an ini- if prior approval from Animal and tial active reaction with hyperemia Plant Health Inspection Service is re- which resolves progressively and dis- ceived. appears within 2 weeks, may be charac- (2) A geometric mean titer of the terized as a typical immune reaction. dried vaccine produced from the high- [39 FR 27430, July 29, 1974. Redesignated at 55 est passage of the Master Seed Virus FR 35562, Aug. 31, 1990, as amended at 56 FR shall be established before the 66786, Dec. 26, 1991] immunogenicity test is conducted. At least 20 mink shall be vaccinated with § 113.302 Distemper Vaccine—Mink. a predetermined quantity of vaccine Distemper Vaccine—Mink shall be virus and at least 5 additional mink prepared from virus-bearing cell cul- shall be held as unvaccinated controls. ture fluids. Only Master Seed Virus To confirm the dosage calculations, which has been established as pure, five replicate virus titrations shall be safe, and immunogenic shall be used conducted on a sample of the vaccine for preparing the production seed virus virus dilution used. for vaccine production. All serials of (3) At least twenty-one days post-in- vaccine shall be prepared from the first jection, the immunity of each of the through the fifth passage from the vaccinates and the controls shall be Master Seed Virus. challenged with the same size dose of (a) The Master Seed Virus shall meet virulent distemper virus and observed the applicable requirements prescribed each day for 21 days. in § 113.300 and the requirements pre- (i) If at least 80 percent of the con- scribed in this section. trols do not die or show severe signs of (b) The lot of Master Seed Virus shall distemper, the test is inconclusive and be tested for extraneous viruses as fol- may be repeated. lows: (ii) If at least 19 of 20, 27 of 30, or 36 (1) To detect virulent canine dis- of 40 of the vaccinates do not survive temper virus, each of two distemper without showing clinical signs of dis- susceptible mink or ferrets shall be in- temper during the observation period, oculated with 1 ml of the Master Seed the Master Seed Virus is unsatisfac- Virus and observed each day for 21 tory.

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(4) An Outline of Production change pared from the first through the tenth shall be made before authority for use passage from the Master Seed. of a new lot of Master Seed Virus shall (a) The Master Seed shall meet the be authorized by Animal and Plant applicable general requirements pre- Health Inspection Service. scribed in § 113.300 and the require- (d) Test requirements for release: ments in this section. Each serial and subserial shall meet (b) Each lot of Master Seed shall be the general requirements prescribed in tested for transmissibility and rever- § 113.300 and the requirements in this sion to virulence in sheep using a paragraph. Final container samples of method acceptable to Animal and completed product shall be tested. Any Plant Health Inspection Service. If re- serial or subserial found unsatisfactory version to virulence is demonstrated, by a prescribed test shall not be re- the Master Seed is unsatisfactory. leased. (c) Each lot of Master Seed used for (1) Mink safety test. Each of 2 mink vaccine production shall be tested for shall be vaccinated with the equivalent immunogenicity. The selected virus of 10 doses of vaccine rehydrated with dose from the lot of Master Seed shall sterile diluent and administered in the be established as follows: manner recommended on the label. The (1) Twenty-five lambs, susceptible to mink shall be observed each day for 21 the bluetongue virus serotype con- days. If unfavorable reactions attrib- tained in the vaccine, shall be used as utable to the product occur in either of test animals (20 vaccinates and 5 con- the mink during the observation pe- trols). Blood samples shall be drawn riod, the serial or subserial is unsatis- from these animals and individual se- factory. If unfavorable reactions which rums tested. A lamb shall be consid- are not attributable to the product ered susceptible if there is no neutral- occur, the test shall be declared incon- ization at a 1:2 final serum dilution in clusive and may be repeated: Provided, a constant virus varying serum neu- That if the test is not repeated, the se- tralization test with 60 to 300 TCID50 of rial or subserial shall be declared un- bluetongue virus or another method ac- satisfactory. ceptable to Animal and Plant Health (2) Potency Test. An in vitro potency Inspection Service. test shall be conducted. To be eligible (2) A geometric mean titer of the vac- for release, each serial and subserial cine produced from the highest passage shall have a virus titer sufficiently from the Master Seed shall be estab- greater than the titer of vaccine virus lished before the immunogenicity test used in the immunogenicity test pre- is conducted. The 20 lambs to be used scribed in paragraph (c) of this section as vaccinates shall be administered a to assure that, when tested at any time predetermined quantity of vaccine within the expiration period, each se- virus by the method recommended on rial and subserial shall have a virus the label. To confirm the virus dosage titer 100.7 greater than that used in administered, five replicate virus titra- such immunogenicity test when tested tions shall be conducted on a sample of by the method used in paragraph (c)(2) the vaccine used. of this section. (3) At least once during the period of [40 FR 53000, Nov. 14, 1975, as amended at 48 14 to 18 days postvaccination, indi- FR 33471, July 22, 1983. Redesignated at 55 FR vidual serum samples shall be collected 35562, Aug. 31, 1990, as amended at 56 FR from each of the vaccinates and tested 66784, 66786, Dec. 26, 1991; 72 FR 72564, Dec. 21, for virus neutralizing antibody using 2007] the 60 to 300 TCID50 of bluetongue virus. § 113.303 Bluetongue Vaccine. (4) Twenty-one to twenty-eight days Bluetongue Vaccine shall be prepared postvaccination the vaccinates and the from virus-bearing cell culture fluids. controls shall each be challenged with Only Master Seed which has been es- virulent bluetongue virus and observed tablished as pure, safe, and for 14 days. The rectal temperature of immunogenic shall be used for pre- each animal shall be taken and re- paring the seeds for vaccine produc- corded for 17 consecutive days begin- tion. All serials of vaccine shall be pre- ning 3 days prechallenge. The presence

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or absence of lesions or other clinical greater than that used in such signs of bluetongue noted and recorded immunogenicity test. on each of 14 consecutive days [50 FR 23796, June 6, 1985. Redesignated at 55 postchallenge. FR 35562, Aug. 31, 1990, as amended at 56 FR (i) If at least four of the five controls 66784, 66786, Dec. 26, 1991; 72 FR 72564, Dec. 21, do not show clinical signs of 2007] bluetongue and a temperature rise of 3 °F or higher over the prechallenge § 113.304 Feline Panleukopenia Vac- mean temperature, the test shall be cine. considered inconclusive and may be re- Feline Panleukopenia Vaccine shall peated. be prepared from virus-bearing cell cul- (ii) If at least 19 of the 20 vaccinates ture fluids. Only Master Seed Virus tested as prescribed in paragraph (c)(3) which has been established as pure, of this section do not have bluetongue safe, and immunogenic shall be used neutralizing antibody titers of 1:4 final for preparing the production seed virus serum dilution or higher, or if more for vaccine production. All serials of than one of the vaccinates shows a vaccine shall be prepared from the first temperature rise of 3 °F or higher than through the fifth passage from the its prechallenge mean temperature for Master Seed Virus. 2 or more days, or if more than one of (a) The Master Seed Virus shall meet the vaccinates exhibits clinical signs of the applicable general requirements prescribed in § 113.300 and the require- bluetongue, the Master Seed is unsatis- ments prescribed in this section. factory. (b) The lot of Master Seed Virus shall (5) An Outline of Production change be tested for other agents as follows: shall be made before authority for use (1) To detect virulent feline of a new lot of Master Seed shall be panleukopenia virus or virulent mink granted by Animal and Plant Health enteritis virus, each of two feline Inspection Service. panleukopenia susceptible cats, as de- (d) Test requirements for release. Each termined by the criteria prescribed in serial and subserial shall meet the ap- paragraph (c)(1) of this section, shall be plicable general requirements pre- injected subcutaneously with the scribed in § 113.300 and the require- equivalent of one cat dose each and the ments in this paragraph. Final con- cats observed each day for 21 days. If tainer samples of completed product either or both cats show signs of dis- shall be tested. Any serial or subserial ease or reduced white blood cell counts found unsatisfactory by a prescribed below 50 percent of the normal level es- test shall not be released. tablished by an average of three or (1) Safety test. The mouse safety test more counts taken prior to injection, prescribed in § 113.33(a) and the lamb the Master Seed Virus is unsatisfac- safety test prescribed in § 113.45 shall be tory. conducted. (2) To detect chlamydial agents, the (2) Virus titer requirements. Final con- Master Seed Virus shall be tested as tainer samples of completed product prescribed in § 113.43. shall be tested for virus titer using the (c) Each lot of Master Seed Virus titration method used in paragraph used for vaccine production shall be (c)(2) of this section. To be eligible for tested for immunogenicity. The se- release, each serial and subserial shall lected virus dose from the lot of Master have a virus titer sufficiently greater Seed Virus shall be established as follows: than the titer of vaccine virus used in the immunogenicity test prescribed in (1) Twenty-five feline panleukopenia susceptible cats shall be used as test paragraph (c) of this section to assure animals (20 vaccinates and 5 controls). that when tested at any time within Blood samples drawn from each cat the expiration period, each serial and shall be individually tested for neutral- 0.7 subserial shall have a virus titer of 10 izing antibody against feline panleukopenia virus to determine susceptibility.

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(i) A constant virus-carrying serum (1) Safety test. The mouse safety test neutralization test in tissue culture prescribed in § 113.33(a) and the cat using 100 to 300 TCID50 of virus shall be safety test prescribed in § 113.39 shall be used. conducted. (ii) Cats shall be considered suscep- (i) Each of two healthy cats shall be tible if there is no neutralization at a injected with 10 cat doses by the meth- 1:2 final serum dilution. od recommended on the label and the (2) A geometric mean titer of the cats observed each day for 14 days. dried vaccine produced from the high- (ii) If unfavorable reactions attrib- est passage of the Master Seed Virus utable to the biological product occur shall be established before the during the observation period, the se- immunogenicity test is conducted. The rial is unsatisfactory. If unfavorable 20 cats used as vaccinates shall be in- reactions occur which are not attrib- jected with a predetermined quantity utable to the product, the test shall be of vaccine virus and the remaining five declared inconclusive and repeated: cats held as uninjected controls. To Provided, That, if not repeated, the se- confirm the dosage calculations, five rial shall be unsatisfactory. replicate virus titrations shall be con- (2) Virus titer requirements. Final conducted on a sample of the vaccine virus tainer samples of completed product dilution used. shall be tested for virus titer using the (3) Fourteen days post-injection, the titration method used in paragraph vaccinates and the controls shall be (c)(2) of this section. To be eligible for challenged with virulent feline release, each serial and each subserial panleukopenia virus furnished by Ani- shall have a virus titer sufficiently mal and Plant Health Inspection Serv- greater than the titer of vaccine virus ice and the cats observed each day for used in the immunogenicity test pre- 14 days. scribed in paragraph (c) of this section (i) If at least 80 percent of the con- to assure that when tested at any time trols do not show clinical signs of fe- within the expiration period, each se- line panleukopenia during the observa- rial and subserial shall have a virus tion period, the test is inconclusive and titer of 100.7 greater than that used in may be repeated. Clinical signs of fe- such immunogenicity test but not less 2.5 line panleukopenia shall include a pro- than 10 TCID50 per dose. nounced leukopenia wherein the white cell count drops to 4,000 or less per [39 FR 44716, Dec. 27, 1974, as amended at 40 FR 53378, Nov. 18, 1975; 43 FR 25078, June 9, cubic mm, or the white cell count 1978; 43 FR 41186, Sept. 15, 1978; 44 FR 58900, drops to less than 25 percent of the nor- Oct. 12, 1979; 48 FR 33471, July 22, 1983. Redes- mal level established by an average of ignated at 55 FR 35562, Aug. 31, 1990, as three or more counts taken prior to amended at 56 FR 66784, 66786, Dec. 26, 1991; 72 challenge. FR 72564, Dec. 21, 2007] (ii) If at least 19 of the 20 vaccinates do not survive the observation period § 113.305 Canine Hepatitis and Canine without showing clinical signs of feline Adenovirus Type 2 Vaccine. panleukopenia as described in para- Canine Hepatitis Vaccine and Canine graph (c)(3)(i) of this section, the Mas- Adenovirus Type 2 Vaccine shall be ter Seed Virus is unsatisfactory. prepared from virus-bearing cell cul- (4) An Outline of Production change ture fluids. Only Master Seed Virus shall be made before authority for use which has been established as pure, of a new lot of Master Seed Virus shall safe, and immunogenic shall be used in be granted by Animal and Plant Health preparing the production seed virus for Inspection Service. vaccine production. All serials shall be (d) Test requirements for release. Each prepared from the first through the serial and subserial shall meet the re- fifth passage from the Master Seed quirements prescribed in § 113.300 and Virus. in this paragraph. Final container sam- (a) The Master Seed Virus shall meet ples of completed product shall be test- the applicable requirements prescribed ed. Any serial or subserial found unsat- in § 113.300 except that the dog safety isfactory by a prescribed test shall not test prescribed in § 113.40(a) shall be be released. conducted by the intravenous route.

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(b) Each lot of Master Seed Virus (i) A geometric mean titer of the used for vaccine production shall be dried vaccine produced from the high- tested for immunogenicity by one or est passage of the Master Seed Virus both of the following methods: shall be established before the (1) Immunogenicity for canine hepatitis. immunogenicity test is conducted. The Twenty-five canine hepatitis suscep- 20 dogs to be used as vaccinates shall tible dogs shall be used as test animals be injected with a predetermined quan- (20 vaccinates and 5 controls). Blood tity of vaccine virus and the remaining samples shall be drawn from these ani- 10 dogs held as uninjected controls. To mals and individual serum samples confirm the dosage calculations, five tested. The dogs shall be considered replicate virus titrations shall be con- susceptible if the results are negative ducted on a sample of the vaccine virus at a 1:2 final serum dilution in a vary- dilution used. ing serum-constant virus neutraliza- (ii) Not less than 14 days postinjection, the vaccinates and the tion test using 50 to 300 TCID50 of canine adenovirus. controls shall be challenged by expo- (i) A geometric mean titer of the sure to a nebulized aerosol of virulent dried vaccine produced from the high- canine adenovirus type 2 furnished or est passage of the Master Seed Virus approved by the Animal and Plant shall be established before the Health Inspection Service and observed immunogenicity test is conducted. The each day for 14 days postchallenge. The 20 dogs to be used as vaccinates shall rectal temperature of each animal be injected with a predetermined quan- shall be taken and the presence of res- tity of vaccine virus and the remaining piratory or other clinical signs of ca- five dogs held as uninjected controls. nine adenovirus type 2 noted and re- To confirm the dosage calculations, corded each day. (A) If at least 6 of 10 controls do not five replicate virus titrations shall be show clinical signs of canine conducted on a sample of the vaccine adenovirus type 2 infection other than virus dilution used. fever, the test is inconclusive and may (ii) Not less than 14 days be repeated. postinjection, the vaccinates and the (B) If a significant difference in clin- controls shall each be challenged intra- ical signs in a valid test cannot be venously with virulent infectious ca- demonstrated between vaccinates and nine hepatitis virus furnished or ap- controls using a scoring system approved by the Animal and Plant Health proved by the Animal and Plant Health Inspection Service and observed each Inspection Service, the Master Seed day for 14 days. Virus is unsatisfactory. (A) If at least four of the five con- (iii) An Outline of Production change trols do not show severe clinical signs shall be made before authorization for of canine hepatitis, the test is incon- use of a new lot of Master Seed Virus clusive and may be repeated. shall be granted by the Animal and (B) If at least 19 of the 20 vaccinates Plant Health Inspection Service. do not survive without showing clinical (c) Test requirements for release. Each signs of infectious canine hepatitis dur- serial and subserial shall meet the re- ing the observation period, the Master quirements prescribed in § 113.300 and Seed Virus is unsatisfactory. in this paragraph. Final container sam- (2) Immunogenicity for canine ples of completed product shall be test- adenovirus Type 2. Thirty canine ed. Any serial or subserial found unsat- adenovirus type 2 susceptible dogs isfactory by a prescribed test shall not shall be used as test animals (20 vac- be released. cinates and 10 controls). Blood samples (1) Virus titer requirements. Final con- shall be drawn from these animals and tainer samples of completed product individual serum samples tested. The shall be tested for virus titer using the dogs shall be considered susceptible if titration method used in paragraph the results are negative at a 1:2 final (b)(1)(i) and/or (b)(2)(i) of this section. serum dilution in a varying serum-con- To be eligible for release, each serial stant virus neutralization test using 50 and each subserial shall have a virus to 300 TCID50 of canine adenovirus. titer sufficiently greater than the titer 761

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of vaccine virus used in the (1) Twenty-five canine distemper sus- immunogenicity test(s) prescribed in ceptible dogs shall be used as test ani- paragraph (b) of this section to assure mals (20 vaccinates and 5 controls). that when tested at any time within Blood samples shall be drawn from the expiration period, each serial and these animals and individual serum subserial shall have a virus titer of 100.7 samples tested. The dogs shall be con- greater than that used in such sidered susceptible if the results are immunogenicity test(s) but not less negative at a 1:2 final serum dilution in 2.5 than 10 TCID50 dose. If both a varying serum-constant virus neu- immunogenicity tests in paragraph (b) tralization test using 50 to 300 TCID50 of this section are conducted and a dif- of canine distemper virus. ferent amount of virus is used in each (2) A geometric mean titer of the test, the virus titer requirements shall dried vaccine produced from the high- be based on the higher of the two est passage of the Master Seed Virus amounts. shall be established before the (2) [Reserved] immunogenicity test is conducted. The 20 dogs used as vaccinates shall be in- [60 FR 14361, Mar. 17, 1995, as amended at 72 jected with a predetermined quantity FR 72564, Dec. 21, 2007] of vaccine virus and the remaining five § 113.306 Canine Distemper Vaccine. dogs held as uninjected controls. To confirm the dosage calculations, five Canine Distemper Vaccine shall be replicate virus titrations shall be con- prepared from virus-bearing cell cul- ducted on a sample of the vaccine virus ture fluids or embryonated chicken dilution used. eggs. Only Master Seed Virus which (3) At least 14 days post-injection, has been established as pure, safe, and the vaccinates and the controls shall immunogenic shall be used for pre- each be challenged intracerebrally paring the production seed virus for with virulent canine distemper virus vaccine production. All serials of vac- furnished or approved by the Animal cine shall be prepared from the first and Plant Health Inspection Service through the fifth passage from the and observed each day for 21 days. Master Seed Virus. (i) If at least four of the five controls (a) Master Seed Virus. The Master do not die and the survivor, if any, does Seed Virus shall meet the applicable not show clinical signs of canine dis- requirements prescribed in § 113.300 and temper the test is inconclusive and the requirements prescribed in this sec- may be repeated. tion. (ii) If at least 19 of the 20 vaccinates (1) To detect ferret virulent canine do not survive without showing clinical distemper virus, each of five canine signs of canine distemper during the distemper susceptible ferrets shall be observation period, the Master Seed injected with a sample of the Master Virus is unsatisfactory. Seed Virus equivalent to the amount of (4) An Outline of Production change virus to be used in one dog dose and ob- shall be made before authorization for served each day for 21 days. If undesir- use of a new lot of Master Seed Virus able reactions are observed during the shall be granted by the Animal and observation period, the lot of Master Plant Health Inspection Service. Seed is unsatisfactory. (c) Test requirements for release. Ex- (2) Master Seed Virus propagated in cept for § 113.300(a)(3)(ii), each serial tissues or cells of avian origin shall be and subserial shall meet the require- tested for pathogens by the chicken ments prescribed in § 113.300 and in this embryo test prescribed in § 113.37. If paragraph. Final container samples of found unsatisfactory, the Master Seed completed product shall be tested. Any Virus shall not be used. serial or subserial found unsatisfactory (b) Each lot of Master Seed Virus by a prescribed test shall not be reused for vaccine production shall be leased. tested for immunogenicity. The se- (1) The test for pathogens prescribed lected virus dose from the lot of Master in § 113.37 shall be conducted on each Seed Virus shall be established as fol- serial or one subserial of avian origin lows: vaccine.

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(2) Virus titer requirements. Final con- considered susceptible if there is no tainer samples of completed product neutralization at a 1:2 final serum dilu- shall be tested for virus titer using the tion in a constant virus-varying serum titration method used in paragraph neutralization test using 60 to 300 (b)(2) of this section. To be eligible for TCID50 of Venezuelan equine release, each serial and subserial shall encephalomyelitis virus. have a virus titer sufficiently greater (3) A geometric mean titer of the vac- than the titer of vaccine virus used in cine produced from the highest passage the immunogenicity test prescribed in of the Master Seed shall be established paragraph (b) of this section to assure using a method acceptable to Veteri- that when tested at any time within nary Services before the the expiration period, each serial and immunogenicity test is conducted. The subserial shall have a virus titer of 100.7 20 horses used as vaccinates shall be in- greater than that used in such jected with a predetermined quantity immunogenicity test but not less than of vaccine virus by the method to be 2.5 10 TCID50 per dose. recommended on the label. To confirm [60 FR 14362, Mar. 17, 1995, as amended at 72 the dosage administered, five replicate FR 72564, Dec. 21, 2007] virus titrations shall be conducted on a sample of the vaccine virus dilution § 113.308 Encephalomyelitis Vaccine, used. Venezuelan. (4) Twenty-one to twenty-eight days Encephalomyelitis Vaccine, Ven- postvaccination, blood samples shall be ezuelan, shall be prepared from virus- drawn from all test animals. For a bearing cell culture fluids. Only Master valid test, the controls shall remain Seed which has been established as seronegative at 1:2 final serum dilu- pure, safe, and immunogenic shall be tion. In a valid test, if at least 19 of 20 used for preparing seeds for vaccine vaccinates do not have antibody titers production. All serials of vaccine shall of at least 1:20 in a hemagglutination- be prepared from the first through the inhibition test or at least 1:40 in a fifth passage from the Master Seed. serum neutralization test, the Master (a) The Master Seed shall meet the Seed is unsatisfactory. applicable general requirements pre- (5) An Outline of Production change scribed in § 113.300 except (b), and the shall be made before authority for use requirements prescribed in this sec- of a new lot of Master Seed shall be tion. granted by Animal and Plant Health (b) Each lot of Master Seed shall be Inspection Service. tested for immunogenicity. The se- (c) Test requirements for release. Each lected virus dose from the lot of Master serial and subserial shall meet the ap- Seed shall be established as follows: plicable general requirements pre- (1) Tests conducted by the Depart- scribed in § 113.300 and special requirement have established that horses hav- ments in this paragraph. Any serial or ing Venezuelan equine subserial found unsatisfactory by a encephalomyelitis antibody titers of prescribed test shall not be released. 1:20 by the hemagglutination-inhibi- (1) Safety test. The mouse safety test tion (HI) method or 1:40 by the serum prescribed in § 113.33(b) shall be con- neutralization (SN) method were im- ducted. mune to challenge with virulent virus. (2) Virus titer requirements. Final con- The immunogenicity test is based on tainer samples of completed product the demonstration of a serological re- shall be tested for virus titer using the sponse of at least that magnitude fol- method in paragraph (b)(3) of this sec- lowing vaccination of serologically tion. To be eligible for release, each se- negative horses. rial and subserial shall have a virus (2) At least 22 horses (20 vaccinates titer sufficiently greater than the titer and 2 controls), susceptible to Ven- of the vaccine used in the ezuelan equine encephalomyelitis, immunogenicity test prescribed in shall be used as test animals. Blood paragraph (b) of this section to assure samples shall be taken from each horse that, when tested at any time within and the serums individually tested for the expiration period, each serial and neutralizing antibody. Horses shall be subserial shall have a virus titer of 100.7

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greater than that used in the five calves held as uninjected controls. immunogenicity test, but not less than To confirm the dosage calculation, five 2.5 10 TCID50 per dose. replicate virus titrations shall be con- [50 FR 23797, June 6, 1985. Redesignated at 55 ducted on a sample of the vaccine virus FR 35562, Aug. 31, 1990, as amended at 56 FR dilution used. 66784, 66786, Dec. 26, 1991; 72 FR 72564, Dec. 21, (3) The vaccinates and controls shall 2007] be examined for clinical signs of respiratory disease and the body tempera- § 113.309 Bovine Parainfluenza3 Vac- ture taken and recorded on each of the cine. first 14 consecutive days post-injection. Bovine Parainfluenza3 Vaccine shall The vaccinates shall be bled on day 6 ±2 be produced from virus-bearing cell days post-injection. culture fluids. Only Master Seed Virus (4) Three to four weeks post-vaccina- which has been established as pure, tion, all calves shall be bled for serum safe, and immunogenic shall be used antibodies and nasal specimens shall be for preparing the production seed virus for vaccine production. All serials of collected for PI3 virus isolation. On the vaccine shall be prepared from the first same day, all vaccinates and controls through the tenth passage from the shall be given acceptable challenge PI3 7.0 Master Seed Virus. virus titrating at least 10 TCID50 per (a) The Master Seed Virus shall meet ml and the animals observed for 14 the applicable general requirements days. Two ml of the challenge virus prescribed in § 113.300. shall be instilled in each nostril or (b) Each lot of Master Seed Virus shall be inhaled as an aerosol suspen- shall meet the special requirements sion. Upon request, challenge virus and prescribed in this section. instructions shall be furnished by Ani- (c) Each lot of Master Seed Virus mal and Plant Health Inspection Serv- used for vaccine production shall be ice. tested for immunogenicity. The se- (5) Each animal shall be examined for lected virus dose from the lot of Master clinical signs of respiratory disease and Seed Virus shall be established as fol- the body temperature recorded on each lows: of the 14 consecutive days of the post- (1) Twenty-five bovine parainfluenza, challenge observation period. Each day susceptible calves shall be used as test for at least the first 10 days post-chal- animals (20 vaccinates and five con- lenge, nasal specimens for virus isola- trols). Blood samples shall be drawn tion attempts shall be taken. All ani- from these animals and individual se- mals shall be bled on day 6 ±2 days rums tested. Also, nasal specimens post-challenge, and all animals shall be shall be collected for virus isolation at- bled at least once 14 to 28 days post- tempts. The calves shall be considered challenge for serum antibody studies. susceptible if: (i) The results are negative at a 1:2 (6) Satisfactory Test Criteria: final serum dilution in a varying serum (i) All virus isolations attempts shall constant virus neutralization test with be by culture and at least one subculture in PI susceptible cells for a total less than 500 TCID50 of bovine 3 parainfluenza3 virus; and of at least 14 days. (ii) Shall be negative to bovine (ii) Two to four weeks post-vaccina- parainfluenza3 virus isolation attempts tion, at least 19 of the 20 vaccinates from the nasal specimens on the day of shall have PI3 neutralizing antibody injection. titers of at least 1:4 and all five con- (2) A geometric mean titer of the trols shall be negative at 1:2 dilution. dried vaccine produced from the high- None of the post-vaccination serums est passage of the Master Seed Virus collected from the vaccinates on day 6 shall be established before the ±2 days shall reveal serum neutraliza- immunogenicity test is conducted. The tion antibody titers of 1:32 or greater 20 calves to be used as vaccinates shall based upon final dilution. be injected with a predetermined quantity of vaccine virus and the remaining

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(iii) Satisfactory resistance to chal- (3) Virus titer requirements. Final con- lenge by vaccinates shall be deter- tainer samples of completed product mined by a significant difference be- shall be tested for virus titer using the tween virus isolation rates from vac- titration method used in paragraph cinates and controls. The virus neu- (c)(2) of this section. To be eligible for tralization titers of post-challenge se- release, each serial and each subserial rums and respiratory symptoms and shall have a virus titer per dose suffi- temperatures from all animals shall be ciently greater than the titer of vac- considered in the evaluation of the test cine virus used in the immunogenicity validity. test prescribed in paragraph (c) of this (7) Designated animal alternates for section to assure that when tested at test animals showing anamnestic anti- any time within the expiration period, body responses (titers 1:32 or greater) each serial and subserial shall have a on day 6 serums may be included in the virus titer of 100.7 greater than that study under the following provisions: used in the immunogenicity test but 2.5 (i) No more than five alternates shall not less than 10 TCID50 per dose. be allowed for the vaccinates and no more than two for the controls. [39 FR 44719, Dec. 27, 1974, as amended at 40 (ii) Alternates shall be subject to all FR 41089, Sept. 5, 1975; 43 FR 49529, Oct. 24, 1978; 48 FR 33472, July 22, 1983. Redesignated requirements outlined for the animals at 55 FR 35562, Aug. 31, 1990, as amended at 56 for which they are alternates. FR 66784, 66786, Dec. 26, 1991; 60 FR 14357, (iii) Antibody values from alternate Mar. 17, 1995; 72 FR 72564, Dec. 21, 2007] animals may be used only to replace values from up to and including five § 113.310 Bovine Rhinotracheitis Vac- vaccinates which develop antibody of cine. 1:32 or greater by day 6 ±2 days post- Bovine Rhinotracheitis Vaccine shall vaccination or up to and including two be prepared from virus-bearing cell cul- controls which develop antibody titers ture fluids. Only Master Seed Virus ± of 1:32 or greater by day 6 2 days post- which has been established as pure, challenge. safe, and immunogenic shall be used (8) A sequential test procedure may for preparing the production seed virus be used in lieu of the 20 calf require- for vaccine production. All serials of ment. A beta value of .05 and a toler- vaccine shall be prepared from the first ance level of .78 shall be required. through the tenth passage from the (9) An Outline of Production change Master Seed Virus. shall be made before authority for use (a) The Master Seed Virus shall meet of a new lot of Master Seed Virus shall the applicable general requirements be granted by Animal and Plant Health Inspection Service. prescribed in § 113.300. (d) Test requirements for release: (b) Each lot of Master Seed Virus Each serial and subserial shall meet shall meet the special requirements the applicable general requirements prescribed in this section. prescribed in § 113.300 and the require- (c) Each lot of Master Seed Virus ments in this paragraph. Final con- used for vaccine production shall be tainer samples of completed product tested for immunogenicity. The se- shall be tested except as prescribed in lected virus dose from the lot of Master paragraph (d)(1) of this section. Any se- Seed Virus shall be established as fol- rial or subserial found unsatisfactory lows: by a prescribed test shall not be re- (1) Twenty-five infectious bovine leased. rhinotracheitis susceptible calves shall (1) Purity test. The test for Brucella be used as test animals (20 vaccinates contamination prescribed in § 113.32 and five controls). Blood samples shall shall be conducted on each batch of pri- be drawn from these animals and indi- mary cells intended for production use. vidual serums tested. The calves shall (2) Safety test. The mouse safety test be considered susceptible if the results prescribed in § 113.33(a) and the calf are negative at a 1:2 final serum dilu- safety test prescribed in § 113.41 shall be tion by the virus plaque reduction conducted. method.

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(2) A geometric mean titer of the (d) Test requirements for release: dried vaccine produced from the high- Each serial and subserial shall meet est passage of the Master Seed Virus the applicable general requirements shall be established before the prescribed in § 113.300 and the require- immunogenicity test is conducted. The ments in this paragraph. Final con- 20 calves to be used as vaccinates shall tainer samples of completed product be injected with a predetermined quan- shall be tested except as prescribed in tity of vaccine virus and the remaining paragraph (d)(1) of this section. Any se- five calves held as uninjected controls. rial or subserial found unsatisfactory To confirm the dosage calculations, by a prescribed test shall not be re- five replicate virus titrations shall be leased. conducted on a sample of the vaccine (1) Purity test. The test for Brucella virus dilution used. contamination prescribed in § 113.32 (3) At least once during a period of 14 shall be conducted on each batch of pri- to 28 days post-vaccination, individual mary cells intended for production use. serum samples shall be collected for (2) Safety test. The mouse safety test virus-neutralization tests from each of prescribed in § 113.33(a) and the calf the vaccinates. The test virus shall be safety test prescribed in § 113.41 shall be 100 to 500 TCID50 bovine rhinotracheitis conducted. virus. Results shall be used in making (3) Virus titer requirements. Final con- a determination as prescribed in para- tainer samples of completed product graph (c)(6) of this section. shall be tested for virus titer using the (4) The vaccinates and the controls titration method used in paragraph shall each be challenged with virulent (c)(2) of this section. To be eligible for infectious bovine rhinotracheitis virus and observed for 14 days. The rectal release, each serial and each subserial temperature of each animal shall be shall have a virus titer per dose suffi- taken and the presence or absence of ciently greater than the titer of vac- respiratory or other clinical signs of cine virus used in the immunogenicity bovine rhinotracheitis noted and retest prescribed in paragraph (c) of this corded on each of the 14 consecutive section to assure that when tested at days. any time within the expiration period, (5) If at least four of the five controls each serial and subserial shall have a 0.7 do not show clinical signs of infectious virus titer of 10 greater than that bovine rhinotracheitis and a marked used in the immunogenicity test but 2.5 temperature rise to 104.5 °F. or higher not less than 10 TCID50 per dose. post-challenge, the test shall be consid- [39 FR 44720, Dec. 27, 1974, as amended at 40 ered inconclusive and may be repeated. FR 20067, May 8, 1975; 40 FR 23989, June 4, (6) If less than 19 of the post-injection 1975; 40 FR 41089, Sept. 5, 1975; 43 FR 49529, serum samples tested as prescribed in Oct. 24, 1978; 48 FR 33472, July 22, 1983. Redes- paragraph (c)(3) of this section show ignated at 55 FR 35562, Aug. 31, 1990, as neutralization in all tubes of the 1:2 amended at 56 FR 66784, 66786, Dec. 26, 1991; 72 final serum dilution, or if more than FR 72564, Dec. 21, 2007] one of the vaccinates show a tempera- ° § 113.311 Bovine Virus Diarrhea Vac- ture of 103.5 F. or higher for 2 or more cine. days, or if more than one of the vaccinates exhibit respiratory or other Bovine Virus Diarrhea Vaccine shall clinical signs of infectious bovine be prepared from virus-bearing cell cul- rhinotracheitis, or both, the Master ture fluids. Only Master Seed Virus Seed Virus is unsatisfactory. which has been established as pure, (7) A sequential test procedure may safe, and immunogenic shall be used be used in lieu of the 20 calf require- for preparing the production seed virus ment. A beta value of .05 and a toler- for vaccine production. All serials of ance level of .78 shall be required. vaccine shall be prepared from the first (8) An outline of Production change through the tenth passage from the shall be made before authority for use Master Seed Virus. of a new lot of Master Seed Virus shall (a) The Master Seed Virus shall meet be granted by Animal and Plant Health the applicable general requirements Inspection Service. prescribed in § 113.300.

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(b) Each lot of Master Seed Virus (5) If less than 19 of the post-injection shall meet the special requirements serum samples, tested as prescribed in prescribed in this section. paragraph (c)(3) of this section, show (c) Each lot of Master Seed Virus neutralization in all tubes of the 1:8 di- used for vaccine production shall be lution; or if more than one of the vac- tested for immunogenicity. The se- cinates exhibits respiratory or other lected virus dose from the lot of Master clinical signs of bovine virus diarrhea Seed Virus shall be established as fol- post-challenge; or both, the Master lows: Seed Virus is unsatisfactory. (1) Twenty-five bovine virus diarrhea (6) A sequential test procedure may susceptible calves shall be used as test be used in lieu of the 20 calf require- animals (20 vaccinates and five con- ment. A beta value of .05 and a toler- trols). Blood samples shall be drawn ance level of .78 shall be required. from these animals and individuals (7) An Outline of Production change serum samples tested. The calves shall shall be made before authority for use be considered susceptible to bovine of a new lot of Master Seed Virus shall virus diarrhea virus infection if the re- be granted by Animal and Plant Health sults are negative at a 1:2 final serum Inspection Service. dilution in a varying serum-constant (d) Test requirements for release: virus neutralization test with less than Each serial and subserial shall meet 500 TCID50 of bovine virus diarrhea the applicable general requirements virus. prescribed in § 113.300 and the require- (2) A geometric mean titer of the ments in this paragraph. Final con- dried vaccine produced from the high- tainer samples of completed product est passage of the Master Seed Virus shall be tested except as prescribed in shall be established before the paragraph (d)(1) of this section. Any se- immunogenicity test is conducted. The rial or subserial found unsatisfactory 20 calves to be used as vaccinates shall by a prescribed test shall not be re- be injected with a predetermined quan- leased. tity of vaccine virus and the remaining (1) Purity test. The test for Brucella five calves held as uninjected controls. contamination prescribed in § 113.32 To confirm the dosage calculations, shall be conducted on each batch of pri- five replicate virus titrations shall be mary cells intended for production use. conducted on a sample of the vaccine (2) Safety test. The mouse safety test virus dilution used. prescribed in § 113.33(a) and the calf (3) At least once during a period 14 to safety test prescribed in § 113.41 shall be 28 days post-vaccination, individual conducted. serum samples shall be collected for (3) Virus titer requirements. Final con- virus-neutralization tests from each of tainer samples of completed product the vaccinates. The test virus shall be shall be tested for virus titer using the less than 500 TCID50 of bovine virus di- titration method used in paragraph arrhea virus. The white cell count for (c)(2) of this section. To be eligible for all vaccinates and controls shall be es- release, each serial and each subserial tablished at least 3 days just before shall have a virus titer per dose suffi- challenge. Results shall be used in ciently greater than the titer of vac- making a determination as prescribed cine virus used in the immunogenicity in paragraph (c)(5) of this section. test prescribed in paragraph (c) of this (4) The vaccinates and the controls section to assure that when tested at shall each be challenged with virulent any time within the expiration period, bovine virus diarrhea virus and ob- each serial and subserial shall have served for 14 consecutive days. The virus titer of 100.7 greater than that white cell count shall be determined used in the immunogenicity test but 2.5 daily on each animal from the second not less than 10 TCID 50 per dose. through the eighth day post-challenge. If leukopenia does not develop in at [39 FR 44721, Dec. 27, 1974, as amended at 40 FR 20067, May 8, 1975; 40 FR 41089, Sept. 5, least four of the five controls as com- 1975; 43 FR 49529, Oct. 24, 1978; 48 FR 33472, pared with the vaccinates, the test July 22, 1983. Redesignated at 55 FR 35562, shall be considered inconclusive and Aug. 31, 1990, as amended at 56 FR 66784, may be repeated. 66786, Dec. 26, 1991; 72 FR 72564, Dec. 21, 2007]

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§ 113.312 Rabies Vaccine, Live Virus. intracerebrally with 0.02 ml of a ground Rabies Vaccine shall be prepared tissue suspension from each organ. Ob- from virus-bearing cell cultures or serve mice each day for 21 days. If any embryonated chicken eggs. Only Mas- mice die, determine if the deaths were ter Seed Virus which has been estab- due to rabies virus in the brain by a lished as pure, safe and immunogenic fluorescent antibody test. shall be used for preparing the produc- (iv) Sacrifice animals that do not tion seed virus for vaccine production. show signs of rabies according to the All serials of vaccine shall be prepared following schedule and check regional from the first through the fifth passage lymph nodes, brain, salivary glands, from the Master Seed Virus. and kidney in suckling mice. (a) The Master Seed Virus shall meet Number of the applicable general requirements Route of injection Days after injection animals prescribed in § 113.300. (1) Each lot of Master Seed Virus Intramuscularly ...... 15, 20, 25, 30, 35 1 each day. shall meet the special requirements Intraneurally ...... 3, 6, 9, 15, 30 1 each day. prescribed in this section. (5) Each lot of Master Seed Virus (2) Each lot of Master Seed Virus shall be tested for safety in at least 10 propagated in tissues or cells of avian unvaccinated serologically negative origin shall be tested for pathogens by animals of each domestic species for procedures prescribed in § 113.37. which the vaccine is recommended. (3) Each lot of Master Seed Virus propagated in primary cell cultures of (i) Each group of 10 animals shall be mouse or hamster origin or brain tis- divided into 2 groups of 5 animals. For sues of mouse origin shall be tested for each species, inject one group lymphocytic choriomeningitis (LCM) intramuscularly with 10 doses of high virus by the procedure prescribed in titer virus. § 113.42. If LCM virus is detected, the (ii) Infiltrate a major nerve of each of Master Seed Virus is unsatisfactory. the animals in the other group of 5 (4) The Master Seed Virus shall be with 10 doses of the same high titer studied in each species of carnivore or virus. For all species except dogs and domesticated wild animal for which cats, multiple injections along the cer- the vaccine is specifically rec- vical spine in the proximity to the ommended to attempt to determine the nerve trunks emerging from the spinal fate of the vaccine virus. Results shall cord may be used: Provided, That a 1- be considered in evaluating safety of dose volume shall be injected into each vaccine virus. of four or more sites bilaterally. (i) Obtain at least 10 unvaccinated (iii) Observe all animals each day for animals, negative at 1:2 final serum di- 90 days. lution, of each species in which tests (iv) If any animals show clinical will be conducted. Divide each species signs of rabies, sacrifice the animal and into two groups of five animals. check appropriate brain tissue for ra- (ii) For each species of animal, inject bies virus by the fluorescent antibody one group of five animals test and by mouse injection. intramuscularly. Infiltrate a major (v) If rabies is confirmed, the lot of nerve and the surrounding tissue in Master Seed Virus is unsatisfactory. each of the five animals in the other (b) The immunogenicity of vaccine group. Use 1.0 ml of high titer virus for prepared with virus at the highest pas- each method of administration. sage of the Master Seed shall be estab- (iii) Observe all animals for signs of lished in each species for which the rabies until scheduled time to sac- vaccine is recommended. Tests shall be rifice. If animals show definite symp- conducted in accordance with a pro- toms, sacrifice and check regional tocol filed with Animal and Plant lymph nodes, brain, salivary glands, Health Inspection Service before initi- and kidney for rabies virus by injection ation of the tests. The vaccine shall be of suckling mice (not more than 7 days prepared using methods prescribed in of age). Tissues may be held frozen at the Outline of Production. If Rabies ¥70 °C. until suckling mice are avail- Vaccine is to be in combination with able. Inject each mouse in one litter other fractions, the product tested

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shall include all fractions to be rec- may be used when the test animals are ommended. of species other than carnivores. Vac- (1) A geometric mean virus titer of cinates shall be challenged at 1 year the dried vaccine produced from the postvaccination. These shall include highest passage of the Master Seed five vaccinates with the lowest SN Virus shall be established before the titers at the 270th-day bleeding, five immunogenicity test is conducted. To vaccinates with the lowest SN titers at confirm the dosage calculations, five the 365th-day bleeding, and all vac- replicate virus titrations shall be con- cinates with SN titers below 1:10 by the ducted on a sample of the vaccine virus mouse SN test or below 1:16 by the dilution used. rapid-fluorescent-focus-inhibition test (2) The dose of vaccine to be used in at any bleeding. At least five SN-nega- the immunogenicity test shall be no tive controls of each species shall be more than the amount of rehydrated challenged at the same time as the vaccine which, on the basis of previous vaccinates. All SN titers shall be titrations, has been diluted to the pro- iterated to an endpoint. All of the chal- posed minimum acceptable virus titer. lenged vaccinates must remain well for (3) Test animals shall be uniform and have no neutralizing antibodies to ra- a period of 90 days, and at least 80 per- bies as determined by serum-neutral- cent of the controls must die of rabies ization (SN) tests. for a satisfactory test without further (i) Twenty-five or more animals shall challenge. If one or more of the vac- be used as vaccinates. Each shall be in- cinates die from rabies, all the remain- jected intramuscularly at one site in ing vaccinates, regardless of titer, the thigh with a dose of vaccine at the along with the five controls shall be proposed minimum virus titer as speci- challenged. The cumulative results fied in the filed Outline of Production. from the two challenges shall be evalu- (ii) Ten or more additional animals ated for acceptance as specified in shall be held as controls. paragraph (b)(3)(v) of this section. (iii) On or about days 30, 90, 180, 270, (5) An outline of Production change and 365 postvaccination, all animals shall be made before authority for use shall be bled and individual serums of a new lot of Master Virus shall be tested for neutralizing antibodies to ra- granted by Animal and Plant Health bies virus. Inspection Service. (iv) All surviving test animals of (c) If more than 1 year duration of each species shall be challenged immunity is to be claimed, a duration intramuscularly with virulent rabies of immunity test for the additional virus furnished or approved by Animal time shall be conducted and inter- and Plant Health Inspection Service 1 preted as prescribed in paragraph (b) of year after vaccination, except as pro- this section for the 1 year test. The vided in paragraphs (b)(4), (b)(5), and test animals shall be monitored sero- (b)(6) of this section. The challenged logically at least every 180 days. The animals shall be observed each day for time of challenge may be adjusted ac- 90 days as prescribed in § 113.5(b). The cordingly. brain of each test animal that dies following challenge shall be examined for (d) Test requirements for release: rabies by the fluorescent antibody test Each serial and each subserial shall or other method acceptable to Animal meet the general requirements pre- and Plant Health Inspection Service. scribed in § 113.300 and special require- (v) Requirements for acceptance in ments in this paragraph. challenge tests shall be death due to (1) Purity and safety tests. Final con- rabies in at least 80 percent of controls tainer samples of completed product while at least 22 of 25 or 26 of 30 or a from each serial or one subserial shall statistically equivalent number of the be tested. vaccinates remain well for a period of (i) The test for pathogens, prescribed 90 days. in § 113.37 shall be conducted on each (4) An alternative to challenging all serial or one subserial of avian origin. surviving test animals in accordance If necessary, neutralize the rabies virus with paragraph (b)(3)(iv) of this section with specific rabies antiserum.

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(ii) A test for safety in three young (4) Suckling mice, 6 days of age or seronegative animals of the most sus- younger, shall be used as test animals ceptible species for which the vaccine when virus in vaccine prepared with a is recommended shall be conducted. high egg passage Flury Strain of rabies Each shall be injected intramuscularly virus is titrated. with 10 recommended doses of vaccine. (i) Six to twelve mice shall be used If unfavorable reactions attributable to for each dilution. Each shall be in- the product occur during a 28 day ob- jected intracerebrally with 0.02 ml. servation period, the serial is unsatis- (ii) The injected suckling mice shall factory. be observed each day for 21 days. (iii) If primary cell cultures of ham- Deaths and paralysis occurring subse- ster origin or of mouse origin are used quent to the fourth day post-injection vaccine production, they shall be test- shall be noted and the LD50 titer cal- ed for LCM virus as prescribed in culated by the Reed and Muench Meth- § 113.42. The cells shall be disrupted and od; and undiluted cell fluids from each lot shall (iii) Virus titer requirements for re- be tested. lease and at expiration date shall be (2) Virus titrations. Final container determined for each vaccine on the samples of completed product shall be basis of data available: Provided, That, tested for virus titer using the titra- the lowest titer permitted at expiration method used in paragraph (b)(1) of tion date when determined by this test 3.0 this section. To be eligible for release, shall be 10 LD50 per 0.02 ml. each serial and each subserial shall [39 FR 44721, Dec. 27, 1974, as amended at 40 have a virus titer sufficiently higher FR 20067, May 8, 1975; 42 FR 6795, Feb. 4, 1977; than the titer of the vaccine virus used 43 FR 49529, Oct. 24, 1978; 50 FR 20090, May 14, in paragraph (b) of this section to as- 1985; 50 FR 23797, June 6, 1985. Redesignated sure that, when tested at any time at 55 FR 35562, Aug. 31, 1990, as amended at 56 within the expiration period, each se- FR 66784, 66786, Dec. 26, 1991; 61 FR 31823, rial and subserial shall have a virus June 21, 1996; 72 FR 72564, Dec. 21, 2007] titer equal to or greater than that used in the immunogenicity test. § 113.313 Measles Vaccine. (3) Young adult mice, each weighing Measles Vaccine shall be prepared 14 to 16 grams, shall be used as test ani- from virus-bearing cell culture fluids. mals when the virus in vaccine pre- Only Master Seed Virus which has been pared with a low egg passage Flury established as pure, safe, and Strain or high cell passage Street Ala- immunogenic shall be used for pre- bama Dufferin Strain (HCP SAD) of ra- paring the production seed virus for bies virus is titrated. At least 10 mice vaccine production. All serials of vac- for each dilution shall be used. cine shall be prepared from the first (i) At least 10 mice shall be used for through the fifth passage from the each dilution. Each shall be injected Master Seed Virus. intracerebrally with 0.03 ml. (a) The Master Seed Virus shall meet (ii) The injected young adult mice the applicable general requirements shall be observed each day for 14 days prescribed in § 113.300. Each lot of Mas- except when testing vaccines made ter Seed Virus shall meet the special with HCP SAD strain of rabies virus, in requirements prescribed in this sec- which case, the mice shall be observed tion. each day for 21 days. Deaths and paral- (b) To detect virulent canine dis- ysis occurring subsequent to the fourth temper virus, each of two canine dis- day post-injection shall be noted and temper susceptible ferrets shall be in- the LD50 titer calculated by the Reed jected with a sample of the Master and Muench Method. Seed Virus equivalent to the amount of (iii) Virus titer requirements for re- virus to be used in one dog dose and ob- lease and at expiration date shall be served each day for 21 days. If undesir- determined for each vaccine on the able reactions occur in either ferret, basis of data available: Provided, That, the lot of Master Seed Virus is unsatis- the lowest titer permitted at expira- factory. tion date when determined by this test (c) Each lot of Master Seed Virus 3.0 shall be 10 LD50 per 0.03 ml. used for vaccine production shall be 770

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tested for immunogenicity. The se- ice, a sequential test procedure may be lected virus dose from the lot of Master used in lieu of the 20 dog requirement. Seed Virus shall be established as fol- A beta value of 0.05 and a tolerance lows: level of 0.78 shall be required. (1) Twenty-five dogs, less than 12 (6) An Outline of Production change weeks of age and free of measles anti- shall be made before authority for use body, shall be used as test animals (20 of a new lot of Master Seed Virus shall vaccinates and five controls). Blood be granted by Animal and Plant Health samples shall be drawn from these ani- Inspection Service. mals and individual serum samples (d) Test requirements for release: tested. The dogs shall be considered Each serial and subserial shall meet susceptible if the results are negative the general requirements prescribed in at a 1:2 final serum dilution in a vary- § 113.300 and the requirements in this ing serum-constant virus neutraliza- paragraph. Final container samples of tion test with less than 500 ID50 of mea- completed product shall be tested. Any sles virus. serial or subserial found unsatisfactory (2) A geometric mean titer of the by a prescribed test shall not be re- dried vaccine produced from the high- leased. est passage of the Master Seed Virus (1) Safety tests. The dog safety test shall be established before the prescribed in § 113.40 and the mouse immunogenicity test is conducted. safety test prescribed in § 113.33(a) shall Twenty dogs shall be vaccinated with a be conducted. predetermined quantity of vaccine (2) Virus titer requirements. Final con- virus and the remaining five dogs held tainer samples of completed product as unvaccinated controls. To confirm shall be tested for virus titer using the the dosage calculations, five replicate titration method used in paragraph virus titrations shall be conducted on a (c)(2) of this section. To be eligible for sample of the vaccine virus dilution release, each serial and each subserial used. shall have a virus titer sufficiently (3) On the day of challenge, serum greater than the titer of the vaccine samples shall be obtained from each virus used in the immunogenicity test vaccinate and individually tested for prescribed in paragraph (c) of this sec- antibody against canine distemper tion to assure that when tested at any virus. For a valid test, each vaccinate time within the expiration period, each shall be negative at a 1:4 final serum serial and subserial shall have a virus dilution in varying serum-constant titer of 100.7 greater than that used in virus neutralization test using less the immunogenicity test but not less than 500 ID of canine distemper virus. 50 than 102.5 ID per dose. (4) At least 21 days postinoculation, 50 the immunity of the vaccinates and [40 FR 53001, Nov. 14, 1975, as amended at 43 controls shall be challenged by expo- FR 49529, Oct. 24, 1978; 48 FR 33472, July 22, sure to a uniform dose of aerosolized 1983. Redesignated at 55 FR 35562, Aug. 31, virulent canine distemper virus. All 1990, as amended at 56 FR 66784, 66786, Dec. test dogs shall be observed daily for 21 26, 1991; 72 FR 72564, Dec. 21, 2007] days postchallenge. § 113.314 Feline Calicivirus Vaccine. (i) If at least 4 of the 5 controls do not die or show signs of distemper, in- Feline Calicivirus Vaccine shall be cluding a temperature of 104.0 °F. or prepared from virus-bearing cell cul- higher and at least 15 percent weight ture fluids. Only Master Seed Virus loss, the test is inconclusive and may which has been established as pure, be repeated. safe, and immunogenic shall be used (ii) If at least 19 of the 20 vaccinates for preparing the production seed virus do not survive without showing a tem- for vaccine production. All serials of perature of 104.0 °F. or higher and a vaccine shall be prepared from the first weight loss exceeding 15 percent after through the fifth passage from the day 8 postchallenge, the Master Seed Master Seed Virus. Virus is unsatisfactory. (a) The Master Seed Virus shall meet (5) When approved in advance by Ani- the applicable general requirements mal and Plant Health Inspection Serv- prescribed in § 113.300.

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(b) The Master Seed Virus shall be (ii) If a significant difference in clin- tested for chlamydial agents as pre- ical signs cannot be demonstrated be- scribed in § 113.43. tween vaccinates and controls using a (c) Each lot of Master Seed Virus scoring system approved by Animal used for vaccine production shall be and Plant Health Inspection Service tested for immunogenicity. The se- and prescribed in the Outline of Pro- lected virus dose from the lot of Master duction, the Master Seed Virus is un- Seed Virus shall be established as fol- satisfactory. lows: (4) An Outline of Production change (1) Thirty feline calicivirus suscep- shall be made before authority for use tible cats shall be used as test animals of a new lot of Master Seed Virus shall (20 vaccinates and 10 controls). Throat be granted by Animal and Plant Health swabs shall be collected from each cat Inspection Service. and individually tested on susceptible (d) Test requirements for release. Each cell cultures for the presence of feline serial and subserial shall meet the re- calicivirus. Blood samples shall be quirements prescribed in § 113.300 and drawn and individual serum samples in this paragraph. Final container sam- tested. The cats shall be considered ples of completed product shall be test- suitable for use if all swabs are nega- ed. Any serial or subserial found unsat- tive for virus isolation and if all se- isfactory by a prescribed test shall not rums are negative for calicivirus anti- be released. body at the 1:2 final dilution in a 50 (1) Safety test. The mouse safety test percent plaque reduction test or other prescribed in § 113.33(a) and the cat SN test of equal sensitivity. safety test prescribed in § 113.39(b) shall (2) A geometric mean titer of the be conducted. dried vaccine produced from the highest passage of the Master Seed Virus (2) Virus titer requirements. Final con- shall be established before the tainer samples of completed product immunogenicity test is conducted. The shall be tested for virus titer using the 20 cats used as vaccinates shall be ad- titration method used in paragraph ministered a predetermined quantity of (c)(2) of this section. To be eligible for vaccine virus by the method to be rec- release, each serial and each subserial ommended on the label and the re- shall have a virus titer sufficiently maining 10 cats shall be held as con- greater than the titer of vaccine virus trols. To confirm the dosage calcula- used in the immunogenicity test pre- tions, five replicate virus titrations scribed in paragraph (c) of this section shall be conducted on a sample of the to assure that when tested at any time vaccine virus dilution used. If two within the expiration period, each se- doses are used, five replicate con- rial and subserial shall have a virus firming titrations shall be conducted titer of 100.7 greater than that used in on each dose. the immunogenicity test but not less 2.5 (3) Twenty-one or more days after than 10 TCID50 or plaque forming the final dose of vaccine, the vac- units per dose. cinates and controls shall each be chal- [44 FR 58899, Oct. 12, 1979; 44 FR 63083, Nov. 2, lenged intranasally with a minimum of 1979, as amended at 48 FR 33472, July 22, 1983. 100,000 TCID50 or plaque forming units Redesignated at 55 FR 35562, Aug. 31, 1990, as of virulent feline calicivirus furnished amended at 56 FR 66784, 66786, Dec. 26, 1991; 72 or approved by Animal and Plant FR 72564, Dec. 21, 2007] Health Inspection Service and observed each day for 14 days postchallenge. The § 113.315 Feline Rhinotracheitis Vac- rectal temperature of each animal cine. shall be taken and the presence or ab- Feline Rhinotracheitis Vaccine shall sence of clinical signs, particularly le- be prepared from virus-bearing cell cul- sions on the oral mucosa, noted and re- ture fluids. Only Master Seed Virus corded each day. which has been established as pure, (i) If less than 8 of 10 controls show safe, and immunogenic shall be used clinical signs of feline calicivirus infec- for preparing the production seed virus tion other than fever, the test is incon- for vaccine production. All serials of clusive and may be repeated. vaccine shall be prepared from the first

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through the fifth passage from the ical signs of feline rhinotracheitis Master Seed Virus. noted and recorded each day. (a) The Master Seed Virus shall meet (i) If less than 8 of 10 controls show the applicable general requirements clinical signs of feline rhinotracheitis prescribed in § 113.300. infection other than fever, the test is (b) The Master Seed Virus shall be inconclusive and may be repeated. tested for chlamydial agents as pre- (ii) If a significant difference in clin- scribed in § 113.43. ical signs cannot be demonstrated be- (c) Each lot of Master Seed Virus tween vaccinates and controls using a used for vaccine production shall be scoring system approved by Veterinary tested for immunogenicity. The se- Services and prescribed in the Outline lected virus dose from the lot of Master of Production, the Master Seed Virus is Seed Virus shall be established as fol- unsatisfactory. lows: (4) An Outline of Production change (1) Thirty feline rhinotracheitis sus- shall be made before authority for use ceptible cats shall be used as test ani- of a new lot of Master Seed Virus shall mals (20 vaccinates and 10 controls). be granted by Animal and Plant Health Throat swabs shall be collected from Inspection Service. each cat and individually tested on sus- (d) Test requirements for release. Each ceptible cell cultures for the presence serial and subserial shall meet the re- of feline rhinotracheitis virus. Blood quirements prescribed in § 113.300 and samples shall be drawn and individual in this paragraph. Final container sam- serum samples tested. The cats shall be ples of completed product shall be test- considered suitable for use if all swabs ed. Any serial or subserial found unsat- are negative for virus isolation and if isfactory by a prescribed test shall not all serums are negative for feline be released. rhinotracheitis virus antibody at the (1) Safety test. The mouse safety test 1:2 final dilution in a 50 percent plaque prescribed in § 113.33(a) and the cat reduction test or other SN test of equal safety test prescribed in § 113.39(b) shall sensitivity. be conducted. (2) A geometric mean titer of the (2) Virus titer requirements. Final con- dried vaccine produced from the high- tainer samples of completed product est passage of the Master Seed Virus shall be tested for virus titer using the shall be established before the titration method used in paragraph immunogenicity test is conducted. The (c)(2) of this section. To be eligible for 20 cats used as vaccinates shall be ad- release, each serial and each subserial ministered a predetermined quantity of shall have a virus titer sufficiently vaccine virus by the method to be rec- greater than the titer of vaccine virus ommended on the label and the reused in the immunogenicity test pre- maining 10 cats shall be held as con- scribed in paragraph (c) of this section trols. To confirm the dosage calcula- to assure that when tested at any time tions, five replicate virus titrations within the expiration period, each se- shall be conducted on a sample of the rial and subserial shall have a virus vaccine virus dilution used. If two titer of 100.7 greater than that used in doses are used, five replicate con- the immunogenicity test but not less 2.5 firming titrations shall be conducted than 10 TCID50 or plaque forming on each dose. units per dose. (3) Twenty-one or more days after [44 FR 58899, Oct. 12, 1979, as amended at 48 the final dose of vaccine, the vac- FR 33472, July 22, 1983. Redesignated at 55 FR cinates and controls shall each be chal- 35562, Aug. 31, 1990, as amended at 56 FR lenged intranasally with a minimum of 66784, 66786, Dec. 26, 1991; 72 FR 72564, Dec. 21, 100,000 TCID50 or plaque forming units 2007] of virulent feline rhinotracheitis virus furnished or approved by Animal and § 113.316 Canine Parainfluenza Vac- Plant Health Inspection Service and cine. observed each day for 14 days post- Canine Parainfluenza Vaccine shall challenge. The rectal temperature of be prepared from virus-bearing cell cul- each animal shall be taken and the ture fluids. Only Master Seed which presence of respiratory or other clin- has been established as pure, safe, and

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immunogenic shall be used for pre- noted and recorded each day for 14 con- paring seeds for vaccine production. All secutive days postchallenge. Nasal serials of vaccine shall be prepared swabs shall be collected from each dog from the first through the fifth passage each day for at least 10 consecutive from the Master Seed. days postchallenge. Individual swabs (a) The Master Seed shall meet the shall be tested for virus isolation by applicable general requirements pre- culture in canine parainfluenza virus scribed in § 113.300 and the require- susceptible cells for at least 7 days. Re- ments in this section. sults shall be evaluated according to (b) Each lot of Master Seed shall be the following criteria: tested for immunogenicity. The se- (i) If five of five controls have not re- lected virus dose shall be established as mained seronegative at a final serum follows: dilution of 1:2 during the prechallenge (1) Twenty-five canine parainfluenza period, the test is inconclusive and susceptible dogs (20 vaccinates and 5 may be repeated. controls) shall be used as test animals. (ii) If more than one vaccinate shows Nasal swabs shall be collected from febrile response, respiratory or other each dog on the day the first dose of clinical signs of canine parainfluenza vaccine is administered and individ- virus infection; or, if less than 19 of 20 ually tested on susceptible cell cul- vaccinates show serum neutralization tures for the presence of canine titers of 1:4 or greater; or, if there is parainfluenza virus. Blood samples not a significant reduction in virus iso- shall also be drawn and individual lation rate in vaccinates when com- serum samples tested for neutralizing pared with controls, the Master Seed is antibody. Dogs shall be considered sus- unsatisfactory. ceptible if all swabs are negative for (5) An Outline of Production change virus isolation and if all serums are shall be made before authority for use negative for canine parainfluenza anti- of a new lot of Master Seed shall be body at a 1:2 final dilution in a con- granted by Animal and Plant Health stant virus-varying serum neutraliza- Inspection Service. tion test using 50 to 300 TCID50 of canine parainfluenza virus. (c) Test requirements for release. Each (2) A geometric mean titer of vaccine serial and subserial shall meet the ap- produced at the highest passage from plicable general requirements pre- the Master Seed shall be established scribed in § 113.300 and the require- before the immunogenicity test is con- ments in this paragraph. Any serial or ducted. The 20 dogs used as vaccinates subserial found unsatisfactory by a shall be administered a predetermined prescribed test shall not be released. quantity of vaccine virus. Five rep- (1) Virus titer requirements. Final con- licate virus titrations shall be container samples of completed product ducted on a sample of the vaccine virus shall be tested for virus titer using the dilution used to confirm the dosage ad- titration method used in paragraph ministered. If two doses are used, five (b)(2) of this section. To be eligible for replicate confirming titrations shall be release, each serial and each subserial conducted on each dose. shall have a virus titer sufficiently (3) Three to 4 weeks after the final greater than the titer of vaccine virus dose of vaccine, all dogs shall be bled used in the immunogenicity test pre- for serum antibodies and nasal swabs scribed in paragraph (b) of this section shall be collected for canine to assure that, when tested at any time parainfluenza virus isolation. On the within the expiration period, each se- same day, all vaccinates and controls rial and subserial shall have a virus shall be challenged with canine titer at least 100.7 greater than that parainfluenza virus furnished or ap- used in the immunogenicity test but 2.5 proved by Animal and Plant Health In- not less than 10 TCID50 per dose. spection Service. (2) [Reserved] (4) The rectal temperature of each [50 FR 436, Jan. 4, 1985. Redesignated at 55 dog shall be taken and the presence of FR 35562, Aug. 31, 1990, as amended at 56 FR respiratory or other clinical signs of 66784, 66786, Dec. 26, 1991; 72 FR 72564, Dec. 21, canine parainfluenza virus infection 2007]

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§ 113.317 Parvovirus Vaccine (Canine). Inspection Service and the dogs ob- Parvovirus Vaccine recommended for served each day for 14 days. Rectal use in dogs shall be prepared from temperature, blood lymphocyte count, virus-bearing cell culture fluids. Only and feces for viral detection shall be Master Seed which has been estab- taken from each dog each day for at lished as pure, safe, and immunogenic least 10 days postchallenge and the shall be used for preparing seeds for presence or absence of clinical signs vaccine production. All serials of vac- noted and recorded each day. cine shall be prepared from the first (i) The immunogenicity of the Mas- through the fifth passage from the ter Seed shall be evaluated on the fol- Master Seed. lowing criteria of infection: tempera- (a) The Master Seed shall meet the ture ≥103.4 °F; lymphopenia of ≥50 per- applicable general requirements pre- cent of prechallenge normal; clinical scribed in § 113.300 and the require- signs such as diarrhea, mucus in feces, ments in this section. or blood in feces; and viral (b) The Master Seed shall be tested hemagglutinins at a level of ≥1:64 in a for reversion to virulence in dogs using 1:5 dilution of feces or a test of equal a method acceptable to Animal and Plant Health Inspection Service. If a sensitivity. If at least 80 percent of the significant increase in virulence is seen controls do not show at least three of within five backpassages, the Master the four criteria of infection during the Seed is unsatisfactory. observation period, the test is incon- (c) Each lot of Master Seed shall be clusive and may be repeated. tested for immunogenicity. The se- (ii) If at least 19 of the 20 vaccinates lected virus dose shall be established as do not survive the observation period follows: without showing more than one cri- (1) Twenty-five canine parvovirus terion of infection described in para- susceptible dogs (20 vaccinates and 5 graph (c)(3)(i), of this section, the Mas- controls) shall be used as test animals. ter Seed is unsatisfactory. Blood samples drawn from each dog (4) An Outline of Production change shall be individually tested for neutral- shall be made before authority for use izing antibody against canine of a new lot of Master Seed shall be parvovirus to determine susceptibility. granted by Animal and Plant Health Dogs shall be considered susceptible if Inspection Service. there is no neutralization at a 1:2 final serum dilution in a constant virus- (d) Test requirements for release. Each varying serum neutralization test in serial and subserial shall meet the applicable general requirements pre- cell culture using 50 to 300 TCID50 of canine parvovirus. scribed in § 113.300 and the require- (2) A geometric mean titer of the vac- ments in this paragraph. Any serial or cine produced at the highest passage subserial found unsatisfactory by a from the Master Seed shall be estab- prescribed test shall not be released. lished before the immunogenicity test (1) Virus titer requirements. Final con- is conducted. The 20 dogs used as vac- tainer samples of completed product cinates shall be administered a pre- shall be tested for virus titer using the determined quantity of vaccine virus titration method used in paragraph by the method recommended on the (c)(2) of this section. To be eligible for label. To confirm the dosage calcula- release, each serial and each subserial tions, five replicate virus titrations shall have a virus titer sufficiently shall be conducted on a sample of the greater than the titer of vaccine used vaccine virus dilution used. If two in the immunogenicity test in para- doses are used, five replicate con- graph (c) of this section to assure that, firming titrations shall be conducted when tested at any time within the ex- on each dose. piration period, each serial and sub- (3) Fourteen days or more after the serial shall have a virus titer of 100.7 final dose of vaccine the vaccinates and the controls shall be challenged with greater than that used in the virulent canine parvovirus furnished or approved by Animal and Plant Health

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immunogenicity test, but not less than (i) If at least four of the five controls 2.5 10 ID50 per dose. do not develop severe central nervous system signs or die, the test is incon- [50 FR 436, Jan. 4, 1985. Redesignated at 55 clusive and may be repeated. FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 66786, Dec. 26, 1991; 72 FR 72564, Dec. 21, (ii) If at least 19 of the 20 vaccinates 2007] in a valid test do not remain free of signs of pseudorabies, the Master Seed § 113.318 Pseudorabies Vaccine. is unsatisfactory. (4) An Outline of Production change Pseudorabies Vaccine shall be pre- shall be made before authority for use pared from virus-bearing cell culture of a new lot of Master Seed shall be fluids. Only Master Seed which has granted by Animal and Plant Health been established as pure, safe, and Inspection Service. immunogenic shall be used for pre- (c) Test requirements for release. Each paring seeds for vaccine production. All serial and subserial shall meet the ap- serials of vaccine shall be prepared plicable general requirements pre- from the first through the fifth passage scribed in § 113.300 and the require- from the Master Seed. ments in this paragraph. (a) The Master Seed shall meet the (2) Virus titer requirements. Final con- applicable general requirements pre- tainer samples of completed product scribed in § 113.300 and the require- shall be titrated by the method used in ments in this section. paragraph (b)(2) of this section. To be (b) Each lot of Master Seed shall be eligible for release, each serial and sub- tested for immunogenicity. The se- serial shall have a virus titer suffi- lected virus dose shall be established as ciently greater than the titer of the follows: vaccine used in the immunogenicity (1) Twenty-five pseudorabies suscep- test prescribed in paragraph (b) of this tible pigs (20 vaccinates and 5 controls) section to assure that, when tested at of the youngest age for which the vac- any time within the expiration period, cine is recommended, shall be used as each serial and subserial shall have a test animals. Blood samples shall be virus titer at least 10.0.7 greater than taken from each pig and the serums in- that used in the immunogenicity test, activated and individually tested for 2.5 but not less than 10 TCID50 per dose. neutralizing antibody against pseudorabies virus. Pigs shall be con- [50 FR 437, Jan. 4, 1985. Redesignated at 55 sidered susceptible if there is no neu- FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 66786, Dec. 26, 1991; 72 FR 72564, Dec. 21, tralization at a 1:2 final serum dilution 2007] in a constant virus-varying serum neutralization test using 50 to 300 TCID50 §§ 113.319–113.324 [Reserved] pseudorabies virus. (2) A geometric mean titer of the vac- § 113.325 Avian Encephalomyelitis cine produced at the highest passage Vaccine. from the Master Seed shall be estab- Avian Encephalomyelitis Vaccine lished before the immunogenicity test shall be prepared from virus-bearing is conducted. The 20 pigs used as vac- tissues or fluids from embryonated cinates shall be administered a pre- chicken eggs. Only Master Seed Virus determined quantity of vaccine virus which has been established as pure, by the method recommended on the safe, and immunogenic in accordance label. To confirm the dosage adminis- with the requirements in paragraphs tered, five replicate virus titrations (a), (b), and (c) of this section shall be shall be conducted on a sample of the used for preparing the production seed vaccine virus dilution used. virus for vaccine production. All serials (3) Fourteen to 28 days shall be prepared from the first postvaccination, the vaccinates and through the fifth passage from the controls shall be challenged with viru- Master Seed Virus. lent pseudorabies virus furnished or ap- (a) The Master Seed Virus shall meet proved by Animal and Plant Health In- the applicable requirements prescribed spection Service and observed each day in § 113.300 and the requirements pre- for 14 days. scribed in this section.

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(b) Each lot of Master Seed Virus (iv) A satisfactory titration shall shall be tested for pathogens by the have at least one dilution with between chicken embryo inoculation test pre- 50 and 100 percent positives and at least scribed in § 113.37, except that, if the one dilution with between 50 and 0 per- test is inconclusive because of a vac- cent positives.

cine virus override, the test may be re- (v) Calculate the EID50 by the peated and if the repeat test is incon- Spearman-Karber or Reed-Muench clusive for the same reason, the chick- method. en inoculation test prescribed in § 113.36 (3) At least 21 days post-vaccination, may be conducted and the virus judged the vaccinates and the controls shall accordingly. be challenged intracerebrally with a (c) Each lot of Master Seed Virus virulent avian encephalomyelitis virus shall be tested for immunogenicity and and observed each day for 21 days. the selected virus dose to be used shall (4) If at least 80 percent of the con- be established as follows: trols do not show signs of avian (1) Avian encephalomyelitis suscep- encephalomyelitis or die, the test is in- tible chickens, all of the same age conclusive and may be repeated. If at (eight weeks or older) and from the least 19 of 20, or 27 of 30, or 36 of 40 of same source, shall be used. Twenty or the vaccinates in each group do not re- more chickens shall be used as vac- main free from clinical signs of avian cinates for each method of administra- encephalomyelitis during the observation recommended on the label. Ten tion period, the Master Seed Virus is additional chickens of the same age unsatisfactory. and from the same source shall be held as unvaccinated controls. (5) An Outline of Production change (2) A geometric mean titer of the vac- shall be made before authority for use cine produced from the highest passage of a new lot of Master Seed Virus shall of the Master Seed Virus shall be es- be granted by Animal and Plant Health tablished before the immunogenicity Inspection Service. test is conducted. Each vaccinate shall (d) After a lot of Master Seed Virus receive a predetermined quantity of has been established as prescribed in vaccine virus. Five replicate virus ti- paragraphs (a), (b), and (c) of this sec- trations shall be conducted on an ali- tion, each serial and subserial shall quot of the vaccine virus to confirm meet the applicable requirements in the amount of virus administered to § 113.300 and the requirements pre- each chicken used in the test. At least scribed in this paragraph. three appropriate (not to exceed ten- (1) Final container samples from fold) dilutions shall be used and the each serial shall be tested for patho- test conducted as follows: gens by the chicken embryo inocula- (i) For each dilution, inoculate at tion test prescribed in § 113.37, except least 10 embryos, 5 or 6 days old, in the that, if the test is inconclusive because yolk sac with 0.2 ml each. Twenty simi- of a vaccine virus override, the chicken lar embryos obtained from the same inoculation test prescribed in § 113.36 source shall be kept as uninoculated may be conducted and the vaccine negative controls. Disregard all deaths judged accordingly. during the first 48 hours post-inocula- (2) Safety test. Final container sam- tion. ples of completed product shall be test- (ii) Eggs for each dilution shall be ed for safety as follows: kept in separate containers and al- (i) At least 25 AE susceptible birds (6 lowed to hatch. Sufficient precaution to 10 weeks of age) shall be vaccinated shall be taken to assure that chickens with the equivalent of 10 doses by each from each dilution remain separated. of all routes recommended on the label To be a valid test, at least 75 percent of and be observed each day for 21 days. the uninoculated eggs shall hatch. (ii) If unfavorable reactions attrib- (iii) On the third day after normal utable to the biological product occur hatching time, count all unhatched during the observation period, the se- eggs and all dead, paralyzed and ataxic rial is unsatisfactory. If unfavorable chickens as positive evidence of viral reactions occur which are not attrib- infection. utable to the product, the test shall be

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declared inconclusive and repeated, ex- additional birds of the same age and cept that, if the test is not repeated, from the same source as the vaccinates the serial shall be unsatisfactory. shall be held as unvaccinated controls. (3) Virus titer requirements. Final con- (2) A geometric mean titer of the tainer samples of completed product dried vaccine produced from the high- shall be tested for virus titer using the est passage of the Master Seed Virus titration method used in paragraph shall be established before the (c)(2) of this section. To be eligible for immunogenicity test is conducted. release, each serial and each subserial Each vaccinate shall receive a pre- shall have a virus titer sufficiently determined quantity of vaccine virus. greater than the titer of vaccine virus Five replicate virus titrations shall be used in the immunogenicity test pre- conducted on an aliquot of the vaccine scribed in paragraph (c) of this section virus to confirm the amount of virus to assure that when tested at any time administered to each bird used in the within the expiration period, each se- test. At least three appropriate (not to rial and subserial shall have a virus exceed tenfold) dilutions shall be used titer of 100.7 greater than that used in and the test conducted as follows: such immunogenicity test but not less (i) For each dilution, inoculate at .5 than 10 EID50 per dose. least five embryos, 9 to 11 days old, on [39 FR 44723, Dec. 27, 1974, as amended at 40 the chorioallantoic membrane with at FR 18405, Apr. 28, 1975; 40 FR 41089, Sept. 5, least 0.2 ml each. Disregard all deaths 1975; 42 FR 43617, Aug. 30, 1977; 48 FR 33473, during the first 24 hours post-inocula- July 22, 1983. Redesignated at 55 FR 35562, tion. To be a valid test, at least four Aug. 31, 1990, as amended at 56 FR 66784, embryos in each dilution shall remain 66786, Dec. 26, 1991; 72 FR 72564, Dec. 21, 2007] viable beyond 24 hours. § 113.326 Avian Pox Vaccine. (ii) Examine the surviving embryos for evidence of infection 5 to 7 days Fowl Pox Vaccine and Pigeon Pox post-inoculation. Vaccine shall be prepared from virus- bearing cell culture fluids or (iii) A satisfactory titration shall embryonated chicken eggs. Only Mas- have at least one dilution with between ter Seed Virus which has been estab- 50 and 100 percent positives and at least lished as pure, safe, and immunogenic one dilution with between 50 and 0 per- in accordance with the requirements in cent positives. paragraphs (a), (b), and (c) of this sec- (iv) Calculate the EID50 by the tion shall be used for preparing the Spearman-Karber or Reed-Muench production seed virus for vaccine pro- method. duction. All serials shall be prepared (3) Fourteen to twenty-one days post- from the first through the fifth passage vaccination, all vaccinates and con- from the Master Seed Virus. trols shall be challenged by the wing (a) The Master Seed Virus shall meet web method and observed each day for the applicable requirements prescribed 10 days. If the wing web method was in § 113.300 except paragraph (c) of this used for vaccination, the opposite wing section and shall meet the require- shall be used for challenge. Challenge ments prescribed in this section. virus shall be provided or approved by (b) Each lot of Master Seed Virus Animal and Plant Health Inspection shall be tested for pathogens by the Service. chicken inoculation test prescribed in (4) If at least 90 percent of the con- § 113.36. trols do not develop fowl pox during (c) Each lot of Master Seed Virus the observation period, the test is in- shall be tested for immunogenicity and conclusive and may be repeated. If at the selected virus dose to be used shall least 19 of 20, or 27 of 30, or 36 of 40 of be established as follows: the vaccinates in each group do not re- (1) Fowl pox susceptible birds all of main free from clinical signs of fowl the same age and from the same pox during the observation period, the source, shall be used as test birds. Master Seed Virus is unsatisfactory. Twenty or more birds shall be used as (5) An Outline of Production change vaccinates for each method of adminis- shall be made before authority for use tration recommended on the label. Ten of a new lot of Master Seed Virus shall

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be granted by Animal and Plant Health shall be declared inconclusive and may Inspection Service. be repeated or, in lieu thereof, the se- (d) After a lot of Master Seed Virus rial declared unsatisfactory. has been established as prescribed in (2) Virus titer requirements. Final con- paragraphs (a), (b), and (c) of this sec- tainer samples of completed product tion, each serial and subserial shall shall be tested for virus titer using the meet the requirements in § 113.36, in titration method used in paragraph § 113.300 except paragraph (c), and in (c)(2) of this section. To be eligible for this paragraph. release, each serial and each subserial (1) Safety test. Final container sam- shall have a virus titer sufficiently ples of completed product from each se- greater than the titer of vaccine virus rial shall be tested. Vaccines rec- used in the immunogenicity test pre- ommended for use in birds 10 days of scribed in paragraph (c) of this section age or younger shall be tested in ac- to assure that when tested at any time cordance with paragraphs (d)(1)(i), (ii), within the expiration period, each se- and (iii) of this section. rial and subserial shall have a virus (i) Each of 25 susceptible birds 5 days titer of 100.7 greater than that used in of age or younger, properly identified and obtained from the same source and such immunogenicity test but not less 2.0 hatch, shall be vaccinated with the than 10 EID50 per dose. equivalent of 10 doses of vaccine by [39 FR 44724, Dec. 27, 1974, as amended at 40 each of all routes recommended on the FR 18406, Apr. 28, 1975; 40 FR 41089, Sept. 5, label and observed each day for 14 days. 1975; 44 FR 33051, June 8, 1979; 48 FR 33473, Severe clinical signs or death shall be July 22, 1983. Redesignated at 55 FR 35562, counted as failures. Two-stage sequen- Aug. 31, 1990, as amended at 56 FR 66784, tial testing may be conducted if the 66786, Dec. 26, 1991; 72 FR 72564, Dec. 21, 2007] first test (which then becomes stage one) has three failures. § 113.327 Bronchitis Vaccine. (ii) The results shall be evaluated ac- Bronchitis Vaccine shall be prepared cording to the following table: from virus-bearing cell culture fluids or embryonated chicken eggs. Only CUMULATIVE TOTALS Master Seed Virus which has been established as pure, safe, and Number of Failures for Failures for Stage birds satisfactory unsatisfactory immunogenic in accordance with the serials serials requirements in paragraphs (a), (b), and 1 ...... 25 ...... 2 or less ...... 4 or more. (c) of this section shall be used for pre- 2 ...... 50 ...... 5 or less ...... 6 or more. paring the production seed virus for vaccine production. All serials shall be (iii) If unfavorable reactions occur prepared from the first through the which are not attributable to the prod- fifth passage from the Master Seed uct, the test shall be declared inconclu- Virus. sive and may be repeated or, in lieu (a) The Master Seed Virus shall meet thereof, the serial declared unsatisfactory. the applicable requirements prescribed (iv) Vaccines not recommended for in § 113.300 and the requirements pre- use in birds 10 days of age or younger scribed in this section. shall be tested for safety as follows: (b) Each lot of Master Seed Virus Each of twenty-five 3- to 5-week-old, shall be tested for pathogens by the fowl-pox susceptible birds shall be vac- chicken embryo inoculation test pre- cinated with the equivalent of 10 doses scribed in § 113.37, except that, if the of vaccine by each of all routes rec- test is inconclusive because of a vac- ommended on the label and observed cine virus override, the test may be re- each day for 14 days. If any of the birds peated and if the repeat test is incon- show severe clinical signs of disease or clusive for the same reason, the chick- death during the observation period en inoculation test prescribed in § 113.36 due to causes attributable to the prod- may be conducted and the virus judged uct, the serial is unsatisfactory. If un- accordingly. favorable reactions occur which are not (c) Each lot of Master Seed Virus attributable to the product, the test used for vaccine production shall be

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tested for immunogenicity and the se- control and vaccinate. Each swab shall lected virus dose to be used shall be es- be placed in a test tube containing 3 ml tablished as follows: of tryptose phosphate broth and anti- (1) Bronchitis susceptible chickens, biotics. The tube and swab shall be all of the same age and from the same swirled thoroughly and if they are to source, shall be used in the virus-recov- be stored, be immediately frozen and ery test. For each method of adminis- be stored at below ¥40 °C. pending egg tration recommended on the label for evaluation. For each chicken swab, at each serotype against which protection least five chicken embryos 9 to 11 days is claimed, twenty or more chickens old shall be inoculated in the allantoic shall be used as vaccinates. Ten addi- cavity with 0.2 ml each of broth from tional chickens for each serotype each tube. against which protection is claimed (ii) All embryos surviving the third shall be held as unvaccinated controls. day post-inoculation shall be used in (2) A geometric mean titer of the the evaluation, except that, if a swab is dried vaccine produced from the high- not represented by at least four em- est passage of the Master Seed Virus bryos, the test of that swab is invalid shall be established before the and the results inconclusive. A tra- immunogenicity tests are conducted. cheal swab shall be positive for virus Each vaccinate shall receive a pre- recovery when any of the embryos in a determined quantity of vaccine virus. valid test show typical infectious bron- Five replicate virus titrations shall be chitis virus lesions, such as but not conducted on an aliquot of the vaccine limited to, stunting, curling, kidney virus to confirm the amount of virus urates, clubbed down, or death during administered to each chicken used in the 4 to 7 day post-inoculation period. such tests. At least three approved (not If less than 20 percent of the embryos to exceed tenfold) dilutions shall be which survive the third day post-inocu- used and the test conducted as follows; lation die during the 4 to 7 day post-in- (i) For each dilution, inject at least oculation period and show no gross le- five embryos, 9 to 11 days old, in the sions typical of infectious bronchitis, allantoic cavity with 0.1 ml each. they may be disregarded. Deaths occurring during the first 24 (iii) If less than 90 percent of the con- hours shall be disregarded, but at least trols are positive for virus recovery, four viable embyros in each dilution the test is inconclusive and may be re- shall survive beyond 24 hours of a valid peated. test. After 5 to 8 days incubation, examine the surviving embryos for evi- (iv) If less than 90 percent of the vac- dence of infection. cinates are negative for virus recovery, (ii) A satisfactory titration shall the Master Seed Virus is unsatisfac- have at least one dilution with between tory. 50 and 100 percent positives and at least (4) An Outline of Production change one dilution with between 50 and 0 per- shall be made before authority for use cent positives. of a new lot of Master Seed Virus shall be granted by Animal and Plant Health (iii) Calculate the EID50 by the Spearman-Karber or Reed-Muench Inspection Service. method. (d) After a lot of Master Seed Virus (3) Twenty-one to twenty-eight days has been established as prescribed in post-vaccination, all vaccinates and paragraphs (a), (b), and (c) of this sec- controls shall be challenged by eye- tion, each serial and subserial shall drop with virulent bronchitis virus. A meet the applicable requirements in separate set of vaccinates and controls § 113.300 and the requirements pre- shall be used for each serotype against scribed in this paragraph, except that, which protection is claimed. Each chal- if the vaccine contains more than one lenge virus shall be approved or pro- virus type, bulk samples taken from vided by Animal and Plant Health In- each type prior to mixing shall be used spection Service and shall titer at least in the virus identity tests prescribed in 4.0 10 EID50 per ml. § 113.300(c). The additional require- (i) Tracheal swabs shall be taken ments in this paragraph shall also be once, 5 days post-challenge, from each met.

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(1) Final container samples from shall not show hemagglutinating activ- each serial shall be tested for patho- ity in the lowest dilution used in the gens by the chicken embryo inocula- titration. tion test prescribed in § 113.37, except (ii) Each bronchitis virus type shall that, if the test is inconclusive because be harvested separately and a sample of a vaccine virus override, the chicken of bulk harvested material shall be col- inoculation test prescribed in § 113.36 lected prior to mixing with the other may be conducted and the vaccine virus type(s). Each sample shall con- judged accordingly. tain not less than the minimum virus (2) Safety test. Final container sam- titer stated in the filed Outline of Pro- ples of completed product shall be test- duction. ed to determine safety for use in bron- (iii) To be eligible for release, each chitis susceptible young chickens. serial and each subserial shall have a (i) Twenty-five susceptible chickens, virus titer sufficiently greater than the 5 days of age or younger, properly iden- titer of vaccine virus used in the tified and obtained from the same immunogenicity test prescribed in source and hatch, shall be vaccinated paragraph (c) of this section to assure by the eye-drop method with the equiv- that when tested at any time within alent of 10 doses of vaccine and ob- the expiration period, each serial and served each day for 21 days post-vac- subserial shall have a virus titer of 100.7 cination. Severe respiratory signs or greater than that used in such death shall be counted as failures. Two- immunogenicity test but not less than 2.0 stage sequential testing may be con- 10 EID50 per dose. ducted if the first test (which then becomes stage one) has three failures. [39 FR 44724, Dec. 27, 1974, as amended at 40 FR 18406, Apr. 28, 1975; 40 FR 41089, Sept. 5, (ii) The results shall be evaluated ac- 1975; 42 FR 43617, Aug. 30, 1977; 48 FR 33473, cording to the following table: July 22, 1983. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, CUMULATIVE TOTALS 66786, Dec. 26, 1991; 64 FR 43045, Aug. 9, 1999; 72 FR 72564, Dec. 21, 2007] Failures for Failures for Stage Number of satisfactory unsatisfactory chickens serials serials § 113.328 Fowl Laryngotracheitis Vac- cine. 1 ...... 25 ...... 2 or less ...... 4 or more. 2 ...... 50 ...... 5 or less ...... 6 or more. Fowl Laryngotracheitis Vaccine shall be prepared from virus-bearing If unfavorable reactions occur which cell culture fluids or embryonated are not attributable to the product, the chicken eggs. Only Master Seed Virus test shall be declared inconclusive and which has been established as pure, repeated or, in lieu thereof, the serial safe, and immunogenic in accordance declared unsatisfactory. with the requirements in paragraphs (3) Virus titer requirements. Final con- (a), (b), and (c) of this section shall be tainer samples of completed product used for preparing the production seed shall be tested for virus titer using the virus for vaccine production. All serials procedure prescribed in paragraph shall be prepared from the first (c)(2) of this section and in this para- through the fifth passage from the graph. Master Seed Virus. (i) The Newcastle disease virus frac- (a) The Master Seed Virus shall meet tion of combined Newcastle-Bronchitis the applicable requirements prescribed Vaccines shall be neutralized prior to in § 113.300 and the requirements pre- titration of the bronchitis virus frac- scribed in this section. tion. Equal parts of heat-inactivated (b) Each lot of Master Seed Virus Newcastle disease antiserum shall be shall be tested for pathogens by the mixed with each appropriate serial ten- chicken embryo inoculation test pre- fold dilution of the vaccine. After inac- scribed in § 113.37, except that, if the tivation, embryos shall be injected test is inconclusive because of vaccine with 0.2 ml each and results calculated virus override, the test may be reas a 0.1 ml dose to allow for serum dilu- peated and if the repeat test is incon- tion of the vaccine. The allantoic clusive for the same reason, the chick- fluids, tested as prescribed in § 113.34 en inoculation test prescribed in § 113.36

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may be conducted and the virus judged one dilution with between 50 and 0 per- accordingly. Each lot shall also be test- cent positives. ed for safety as follows: (iv) Calculate the EID50 by the (1) Each of at least ten 3 to 4 week Spearman-Karber or Reed-Muench old susceptible chickens obtained from method. the same source and hatch as those (3) Tissue culture origin vaccine may used in the immunogenicity test pre- be titrated by a tissue culture method scribed in paragraph (c) of this section approved by Animal and Plant Health shall be injected intratracheally with Inspection Service and written into the 0.2 ml of the virus as used in the vac- filed Outline of Productions. cine and the chickens observed each (4) Ten to fourteen days post-vaccina- day for 14 days. tion, all vaccinates and controls shall (2) If more than 20 percent of the be challenged intratracheally or in the chickens die during the observation pe- orbital sinus with infectious fowl riod, the virus is unsatisfactory. laryngotracheitis virus and observed (c) Each lot of Master Seed Virus each day for 10 days. Challenge virus used for vaccine production shall be shall be provided or approved by Ani- tested for immunogenicity and the se- mal and Plant Health Inspection Serv- lected virus dose to be used shall be es- ice. tablished as follows: (5) If at least 80 percent of the con- (1) Fowl laryngotracheitis suscep- trols do not die or show clinical signs tible chickens all of the same age and of fowl laryngotracheitis during the ob- from the same source shall be used. servation period, the test is inconclu- Twenty or more chickens shall be used sive and may be repeated. If at least 19 as vaccinates for each method of ad- of 20, 27 of 30, or 36 of 40 of the vac- ministration recommended on the cinates in each group do not remain label. Ten additional chickens of the free of clinical signs of fowl same age and from the same source laryngotracheitis during the observa- shall be held as unvaccinated controls. tion period, the Master Seed Virus is (2) A geometric mean titer of the unsatisfactory. dried vaccine produced from the high- (6) An Outline of Production change est passage of the Master Seed Virus shall be made before authority for use shall be established before the of a new lot of Master Seed Virus shall immunogenicity test is conducted. be granted by Animal and Plant Health Each vaccinate shall receive a pre- Inspection Service. determined quantity of vaccine virus. (d) After a lot of Master Seed Virus Five replicate virus titrations shall be has been established as prescribed in conducted on an aliquot of the vaccine paragraphs (a), (b), and (c) of this sec- virus to confirm the amount of virus tion, each serial and subserial shall administered to each chicken used in meet the applicable requirements in the test. At least three appropriate § 113.300 and the requirements pre- (not to exceed tenfold) dilutions shall scribed in this paragraph. be used for vaccine of chicken embryo (1) Final container samples from origin and the test conducted as fol- each serial shall be tested for patho- lows: gens by the chicken embryo inocula- (i) For each dilution, inject at least tion test prescribed in § 113.37, except five embryos, 9 to 11 days old, on the that, if the test is inconclusive because chorioallantoic membrane with 0.2 ml of a vaccine virus override, the chicken each. Disregard all deaths during the inoculation test prescribed in § 113.36 first 24 hours post-injection. To be a may be conducted and the vaccine valid test, at least four embryos in judged accordingly. each dilution shall remain viable be- (2) Safety test. Final container sam- yond 24 hours. ples of completed product from each se- (ii) Examine the surviving embryos rial of modified live virus vaccine shall for evidence of infection 5 to 8 days be tested for safety as provided in this post-injection. paragraph. Live virus vaccine not pre- (iii) A satisfactory titration shall pared with modified live virus shall be have at least one dilution with between tested for safety as provided in the 50 and 100 percent positives and at least filed Outline of Production.

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(i) Twenty-five 3 to 4 week old has been established as pure, safe, and laryngotracheitis susceptible chickens immunogenic in accordance with the shall be injected intratracheally with requirements in paragraphs (a), (b), and 0.2 ml of vaccine rehydrated at the rate (c) of this section shall be used for pre- of 30 ml for 1,000 doses. Chickens shall paring the production seed virus for be observed each day for 14 days. vaccine production. All serials shall be Deaths shall be counted as failures. prepared from the first through the Two-stage sequential testing may be fifth passage from the Master Seed conducted if the first test (which then Virus. becomes stage one) has five, six, or (a) The Master Seed Virus shall meet seven failures. the applicable requirements prescribed (ii) The results shall be evaluated ac- in § 113.300, except § 113.34, and the recording to the following table: quirements prescribed in this section. (b) Each lot of Master Seed Virus CUMULATIVE TOTALS shall be tested for pathogens by the chicken embryo inoculation test pre- Failures for Failures for Number of scribed in § 113.37, except that, if the Stage chickens satisfactory unsatisfactory serials serials test is inconclusive because of a vac- 1 ...... 25 ...... 4 or less ...... 8 or more. cine virus override, the test may be re- 2 ...... 50 ...... 10 or less .... 11 or more. peated and if the repeat test is inconclusive for the same reason, the chick- (iii) If unfavorable reactions occur en inoculation test prescribed in § 113.36 which are not attributable to the prod- may be conducted and the virus judged uct, the test shall be declared inconclu- accordingly. sive and repeated or in lieu thereof, the (c) Each lot of Master Seed Virus serial declared unsatisfactory. used for vaccine production shall be (3) Virus titer requirements. Final con- tested for immunogenicity and the se- tainer samples of completed product lected virus dose to be used shall be es- shall be tested for virus titer using the tablished as follows: titration method provided in para- (1) Newcastle Disease susceptible graphs (c)(2) or (3) of this section. To be chickens, all of the same age and from eligible for release, each serial and the same source, shall be used. Twenty each subserial shall have a virus titer or more chickens shall be used as vac- sufficiently greater than the titer of cinates for each method of administra- vaccine virus used in the tion recommended on the label. Ten immunogenicity test prescribed in additional chickens of the same age paragraph (c) of this section to assure and from the same source shall be held that when tested at any time within as unvaccinated controls. the expiration period, each serial and (2) A geometric mean titer of the subserial shall have a virus titer of 100.7 dried vaccine produced from the high- greater than that used in such est passage of the Master Seed Virus immunogenicity test but not less than shall be established before the 2.5 10 EID50 per dose for chicken embryo immunogenicity test is conducted. 2.0 2.5 origin vaccine and 10 EID50 or 10 Each vaccinate shall receive a pre- TCID50 per dose for tissue culture ori- determined quantity of vaccine virus. gin vaccine. Five replicate virus titrations shall be conducted on an aliquot of the vaccine [39 FR 44726, Dec. 27, 1974, as amended at 40 FR 18407, Apr. 28, 1975; 40 FR 41089, Sept. 5, virus to confirm the amount of virus 1975; 41 FR 44359, Oct. 8, 1976; 42 FR 43617, administered to each chicken used in Aug. 30, 1977; 48 FR 33473, July 22, 1983. Re- the test. At least three appropriate designated at 55 FR 35562, Aug. 31, 1990, as (not to exceed tenfold) dilutions shall amended at 56 FR 66784, 66786, Dec. 26, 1991; 72 be used and the test conducted as fol- FR 72564, Dec. 21, 2007] lows: (i) For each dilution, inject at least § 113.329 Newcastle Disease Vaccine. five embryos, 9 to 11 days old, in the Newcastle Disease Vaccine shall be allantoic cavity with at least 0.1 ml prepared from virus-bearing cell cul- each. Disregard all deaths during the ture fluids or embryonated chicken first 24 hours post-injection. To be a eggs. Only Master Seed Virus which valid test, at least four embryos in

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each dilution shall remain viable be- er the vaccine is safe for use in suscep- yond 24 hours. tible young chickens. Vaccines rec- (ii) Examine the surviving embryos ommended for use in chickens 10 days for evidence of infection 5 to 7 days of age or younger shall be tested in ac- post-injection. cordance with paragraphs (d)(2)(i), (ii), (iii) A satisfactory titration shall and (iii) of this section. have at least one dilution with between (i) Twenty-five susceptible chickens, 50 and 100 percent positives and at least 5 days of age or younger, properly iden- one dilution with between 50 and 0 per- tified and obtained from the same cent positives. source and hatch, shall be vaccinated (iv) Calculate the EID50 by the by the eye drop method with the equiv- Spearman-Karber or Reed-Muench alent of 10 doses of vaccine and the method. chickens observed each day for 21 days. (3) Twenty to twenty-eight days Severe respiratory signs or death shall postvaccination, all vaccinates and be counted as failures. Two-stage se- controls shall be challenged quential testing may be conducted if intramuscularly with at least 104.0 the first test (which then becomes EID50 of virus per chicken and observed stage one) has 3 failures. each day for 14 days. Challenge virus (ii) The results shall be evaluated ac- shall be provided or approved by Ani- cording to the following table: mal and Plant Health Inspection Serv- ice. CUMULATIVE TOTALS (4) If at least 90 percent of the con- Failures for Failures for trols do not develop clinical signs of Number of Stage chickens satisfactory unsatisfactory Newcastle disease during the observa- serials serials tion period, the test is inconclusive and 1 ...... 25 ...... 2 or less ...... 4 or more. may be repeated. If at least 19 of 20, or 2 ...... 50 ...... 5 or less ...... 6 or more. 27 of 30, or 36 of 40 of the vaccinates in each group do not remain free from (iii) If unfavorable reactions occur clinical signs of Newcastle disease dur- which are not attributable to the prod- ing the observation period, the Master uct, the test shall be declared inconclu- Seed Virus is unsatisfactory. sive and may be repeated. (5) A strain identity test acceptable (iv) Vaccines not recommended for to Animal and Plant Health Inspection use in chickens 10 days of age or Service shall be conducted. younger shall be tested for safety as (6) An Outline of Production change follows: shall be made before authority for use Each of twenty-five 3 to 5 week old of a new lot of Master Seed Virus shall Newcastle disease susceptible chickens be granted by Animal and Plant Health shall be vaccinated as recommended on Inspection Service. the label with the equivalent of ten (d) After a lot of Master Seed Virus doses and observed each day for 21 has been established as prescribed in days. If any of the birds show severe paragraphs (a), (b), and (c) of this sec- clinical signs of disease or death during tion, each serial and subserial shall the observation period due to causes meet the applicable requirements in attributable to the product, the serial § 113.300, except § 113.34, and the require- is unsatisfactory. ments prescribed in this paragraph. (3) Virus titer requirements. Final con- (1) Final container samples from tainer samples of completed product each serial shall be tested for patho- shall be tested for virus titer using the gens by the chicken embryo inocula- titration method used in paragraph tion test prescribed in § 113.37, except (c)(2) of this section. To be eligible for that, if the test is inconclusive because release, each serial and each subserial of a vaccine virus override, the chicken shall have a virus titer per dose suffi- inoculation test prescribed in § 113.36 ciently greater than the titer of vac- may be conducted and the vaccine cine virus used in the immunogenicity judged accordingly. test prescribed in paragraph (c) of this (2) Safety test: Final container sam- section to assure that when tested at ples of completed product from each se- any time within the expiration period, rial shall be tested to determine wheth- each serial and subserial shall have a

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virus titer of 100.7 greater than that (iv) Group 4. For studies evaluating used in the immunogenicity test but Serotype 1 Master Seed Viruses, a 5.5 not less than 10 EID50 per dose. group of 50 uninoculated control chickens shall be housed in contact with the [39 FR 44727, Dec. 27, 1974, as amended at 40 FR 18407, Apr. 28, 1975; 40 FR 23721, June 2, group 1 vaccinated chickens. 1975; 40 FR 41090, Sept. 5, 1975; 42 FR 43618, (2) At least 40 chickens in each group Aug. 30, 1977; 48 FR 33473, July 22, 1983. Re- shall survive to 5 days of age. All designated at 55 FR 35562, Aug. 31, 1990, as chickens that die shall be necropsied amended at 56 FR 66784, 66786, Dec. 26, 1991; 72 and examined for lesions of Marek’s FR 72564, Dec. 21, 2007] disease and cause of death. The test shall be judged according to the fol- § 113.330 Marek’s Disease Vaccines. lowing criteria: Marek’s disease vaccine shall be pre- (i) At 50 days of age, the remaining pared from virus-bearing tissue culture chickens in group 2 shall be killed and cells. Only Master Seed Virus which examined for gross lesions of Marek’s has been established as pure, safe, and disease. If at least 80 percent of this immunogenic shall be used for pre- group do not develop Marek’s disease, paring the production seed virus for the test is inconclusive and may be re- vaccine production. peated. (a) The Master Seed Virus shall meet (ii) At 120 days of age, the remaining the applicable requirements prescribed chickens in groups 1, 3, and 4 shall be in § 113.300, and the requirements pre- weighed, killed, and necropsied. If less scribed in this section. The identity than 30 of the chickens in group 3 sur- test required in § 113.300(c) shall be con- vive the 120 day period, or if any of the ducted in a serotype-specific manner chickens in group 3 have gross lesions by a method acceptable to APHIS. of Marek’s disease at necropsy, the test Each lot of Master Seed Virus shall is declared inconclusive. If less than 30 also be tested for pathogens by the chickens in groups 1 and 4 survive the chicken embryo inoculation test pre- 120 day period; or if any of the chickens scribed in § 113.37, except that, if the in groups 1 and 4 have gross lesions of test is inconclusive because of a vac- Marek’s disease at necropsy; or if the cine virus override, the chicken inocu- average body weight of the chickens in lation test prescribed in § 113.36 may be groups 1 or 4 is significantly (statis- conducted and the virus judged accord- tically) different from the average in ingly. group 3 at the end of the 120 days, the (b) Safety test. The Master Seed Virus lot of Master Seed Virus is unsatisfac- shall be nonpathogenic for chickens as tory. determined by the following procedure: (3) For tests involving in ovo inocula- (1) Specific pathogen free chickens or tion, hatchability results shall also be embryos, negative for Marek’s disease reported for each group. virus antibodies, and from the same (c) Immunogenicity. Each lot of Mas- source, shall be isolated into the fol- ter Seed Virus used for vaccine produc- lowing groups: tion shall be tested for (i) Group 1. At least 50 test subjects immunogenicity at the highest passage shall be inoculated with 10 times as level allowed for the product, and the much viable virus as will be contained virus dose to be used shall be estab- in one dose of vaccine, by the route lished as follows: recommended for vaccination. (1) Specific pathogen free chickens or (ii) Group 2. At least 50 test subjects embryos, negative for Marek’s disease shall be injected with a very virulent antibodies, and from the same source, Marek’s disease virus provided or ap- shall be isolated into the following proved by APHIS, at a dosage level groups: that will cause gross lesions of Marek’s (i) Group 1. A minimum of 35 test sub- disease in at least 80 per cent of the jects shall be inoculated with the vac- chickens within 50 days. cine, using the recommended route, at (iii) Group 3. Fifty uninoculated con- 1 day of age for chicks or 18 days of trols. For in ovo studies, this group embryonation for embryos. The dose should receive a sham inoculation of used shall be established by 5 replicate diluent. virus titrations conducted by a cell

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culture system or other titration or to aid in the prevention of very viru- method acceptable to APHIS. lent Marek’s disease, for all other vac- (ii) Group 2. A minimum of 35 nonvac- cines. cinated test subjects shall be held as (d) Test requirements for release. Each challenge controls. serial and subserial shall meet the ap- (iii) Group 3. A minimum of 25 non- plicable requirements prescribed in vaccinated test subjects shall be held § 113.300. The identity test required in as nonchallenge controls. § 113.300(c) shall be conducted in a (iv) Group 4. Except for studies evalu- serotype-specific manner by a method ating vaccines which contain only a acceptable to APHIS. Final container Serotype 3 virus as the Marek’s disease samples of completed product shall fraction, a minimum of 35 chicks shall also meet the requirements in para- be vaccinated at 1 day of age with a li- graphs (d) (1), (2), and (3) of this sec- censed Serotype 3 vaccine, in order to tion. Any serial or subserial found un- document the severity of the very viru- satisfactory by a prescribed test shall lent challenge. not be released. (2) At least 30 chickens in groups 1, 2, (1) Purity test. The chicken embryo and 4, and at least 20 chickens in group inoculation test prescribed in § 113.37 3, shall survive to 5 days of age. All shall be conducted, except that, if the chickens in groups 1, 2, and 4 shall be test is inconclusive because of a vac- challenged at 5 days of age in the fol- cine virus override, the chicken inocu- lowing manner: lation test prescribed in § 113.36 may be (i) For studies evaluating vaccines conducted and the virus judged accord- which contain only a Serotype 3 virus ingly. as the Marek’s disease fraction, groups (2) Safety test. At least 25 one-day-old, 1 and 2 shall be inoculated with a specific pathogen free chickens shall be standard virulent challenge virus pro- injected, by the subcutaneous route, vided or approved by APHIS. with the equivalent of 10 chicken doses (ii) For all other Marek’s disease vac- of virus (vaccine concentrated 10X). cines, groups 1, 2, and 4 shall be inocu- The chickens shall be observed each lated with a very virulent challenge day for 21 days. Chickens dying during virus provided or approved by APHIS. the period shall be examined, cause of (3) All chickens shall be observed death determined, and the results re- until 7 weeks of age, necropsied, and corded. examined for grossly observable lesions (i) If at least 20 chickens do not sur- consistent with Marek’s disease. All vive the observation period, the test is chickens dying before the end of the 7 inconclusive. week observation period shall be (ii) If lesions of any disease or cause necropsied and evaluated for gross le- of death are directly attributable to sions of Marek’s disease. Any chickens the vaccine, the serial is unsatisfac- not so examined shall be scored as posi- tory. tive for Marek’s disease. (iii) If less than 20 chicks survive the (4) For a valid test, at least 80 per- observation period and there are no cent of the chickens in group 2 must deaths or lesions attributable to the develop grossly observable lesions, vaccine, the test may be repeated one none of the chickens in group 3 shall time, Provided, that if the test is not develop grossly observable lesions, and repeated, the serial shall be declared (when included) greater than 20 percent unsatisfactory. of the chickens in group 4 must develop (3) Potency test. The samples shall be grossly observable lesions. titrated using a cell culture system or (5) For a valid test to be considered other titration method acceptable to satisfactory, at least 80 percent of the APHIS. For vaccines composed of more chickens in group 1 must remain free of than one Marek’s disease virus grossly observable lesions. The appro- serotype, each fraction shall be priate product claim resulting from a titrated in a serotype-specific manner. satisfactory test would be to aid in the (i) Samples of desiccated vaccine prevention of Marek’s disease, for vac- shall be incubated at 37 °C for 3 days cines containing only a Serotype 3 before preparation for use in the po- virus as the Marek’s disease fraction, tency test. Samples of desiccated or

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frozen vaccine shall be reconstituted in ommended dose of vaccine virus and diluent according to the label rec- observed for 21 days. Fifteen chickens ommendations, and held in an ice bath of the same source and hatch shall be at 0 °C to 4 °C for 2 hours prior to use kept isolated as controls. in the potency test. (i) Seventeen days postvaccination, (ii) For a serial or subserial to be eli- each of five controls shall be adminis- 2.0 gible for release, each serotype con- tered at least 10 EID50 of a virulent tained in the vaccine shall have a virus bursal disease virus by eye-drop, iso- titer per dose which is at least 3 times lated, and used as positive controls. greater than the number of plaque The remaining controls shall be used as forming units (pfu) used in the negative controls. immunogenicity test prescribed in (ii) If the vaccinates do not remain paragraph (c) of this section, but not free of clinical signs of bursal disease, less than 1000 pfu per dose. the Master Seed Virus is unsatisfac- (iii) When tested (without the pretest tory. If unfavorable reactions which incubation of desiccated products) at are not attributable to the Master Seed any time within the expiration period, Virus occur in more than two of the each serotype contained in the vaccine vaccinates, the test shall be declared shall have a virus titer per dose which inconclusive and may be repeated. is at least 2 times the number of pfu (iii) Twenty-one days used in the immunogenicity test, but postvaccination, the vaccinates and not less than 750 pfu per dose. the controls shall be necropsied and ex- [61 FR 33841, July 1, 1996] amined for gross lesions of bursal disease. If more than two of the vac- § 113.331 Bursal Disease Vaccine. cinates have such lesions, the Master Bursal Disease Vaccine shall be pre- Seed Virus is unsatisfactory, except pared from virus-bearing cell culture that, if any of the negative controls or fluids or embryonated chicken eggs. less than four of the positive controls Only Master Seed Virus which has been have such lesions, the test is inconclu- established as pure, safe, and sive and may be repeated. For purposes immunogenic in accordance with the of this test, gross lesions shall include requirements in paragraphs (a), (b), and obvious pathological processes and/or (c) of this section shall be used for pre- obvious reduction in size of the bursa paring the production seed virus for from normal. vaccine production. All serials shall be (2) Each of thirty-five 3- to 4-week- prepared from the first through the old bursal disease susceptible chickens fifth passage from the Master Seed (vaccinates) shall be vaccinated with Virus. approximately one minimum protec- (a) The Master Seed Virus shall meet tive dose of vaccine virus as deter- the applicable requirements prescribed mined in paragraph (c) of this section. in § 113.300 and the requirements pre- Each of 10 chickens of the same source scribed in this section. and hatch shall be administered at 2.0 (b) Each lot of Master Seed Virus least 10 EID50 of a virulent bursal dis- shall be tested for pathogens by the ease virus by eye-drop, isolated, and chicken embryo inoculation test pre- used as positive controls. Also, each of scribed in § 113.37, except that, if the 20 additional chickens of the same test is inconclusive because of a vac- source and hatch shall be isolated and cine virus override, the chicken inocu- held as negative controls. lation test prescribed in § 113.36 may be (i) Three or four days conducted and the virus judged accord- postvaccination, 10 of the vaccinates, ingly. Each lot of Master Seed Virus the 10 positive controls, and 10 of the used in the preparation of modified live negative controls shall be necropsied virus vaccines shall also be nonpatho- and examined for gross lesions of genic to chickens as determined by the bursal disease. If any of the vaccinates following procedures: have such lesions, the Master Seed (1) Each of twenty-five 1-day-old Virus is unsatisfactory, except that, if bursal disease susceptible chickens any of the negative controls or less (vaccinates) shall be injected than 8 of the positive controls have subcutaneously with 10 times the rec- such lesions, the test is inconclusive

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and may be repeated. For purposes of Seed Virus is unsatisfactory, except this test, gross lesions shall include that, if less than 90 percent of the con- peri-bursal edema and/or edema and/or trols have such lesions, the test is in- macroscopic hemorrhage in the bursal conclusive and may be repeated. tissue. (4) An Outline of Production change (ii) Fourteen days post-vaccination, shall be made before authority for use the remaining vaccinates and negative of a new lot of Master Seed Virus shall controls shall be necropsied and exam- be granted by Animal and Plant Health ined for obvious bursal atrophy. If any Inspection Service. of the vaccinates have such atrophy, (d) After a lot of Master Seed Virus the Master Seed Virus is unsatisfac- has been established as prescribed in tory, except that, if any of the negative paragraphs (a), (b), and (c) of this sec- controls have such atrophy, the test is tion, each serial and subserial shall inconclusive and may be repeated. meet the applicable requirements in (c) Each lot of Master Seed Virus § 113.300 and the requirements pre- shall be tested for immunogenicity and scribed in this paragraph. the selected virus dose to be used shall (1) Tests for pathogens. Final con- be established as follows: tainer samples from each serial shall (1) Bursal Disease susceptible chick- be tested for pathogens by the chicken ens, all of the same age (3 weeks or embryo inoculation test prescribed in younger) and from the same source, § 113.37, except that, if the test is incon- shall be used. Twenty or more chickens clusive because of a vaccine virus over- shall be used as vaccinates for each ride, the chicken inoculation test pre- method of administration rec- scribed in § 113.36 may be conducted and ommended on the label. Ten additional the serial judged accordingly. chickens of the same age and from the (2) Safety tests. (i) Final container same source shall be held as samples of completed product from unvaccinated controls. each serial shall be tested to determine (2) A geometric mean titer of the vac- whether the vaccine is safe as follows: cine produced from the highest passage (A) For vaccines intended for paren- of the Master Seed Virus shall be es- teral administration, each of twenty- tablished before the immunogenicity five 1-day-old bursal disease suscep- test is conducted. Each vaccinate shall tible chickens shall be vaccinated with receive a predetermined quantity of the equivalent of 10 doses by subcuta- vaccine virus. Five replicate virus ti- neous injection. trations shall be conducted on an ali- (B) For vaccines intended for drink- quot of the vaccine virus to confirm ing water administration, each of the amount of virus administered to twenty-five 4- to 5-week-old bursal dis- each chicken used in the test. At least ease susceptible chickens shall be vac- three appropriate (not to exceed ten- cinated orally with the equivalent of 10 fold) dilutions shall be used to conduct doses. the titrations by a method acceptable (C) Ten chickens of the same source to Animal and Plant Health Inspection and hatch shall be maintained in isola- Service. tion as negative controls. The vac- (3) When the test chickens are 28 to cinates and controls shall be observed 35 days of age but not less than 14 days each day for 21 days. postvaccination, each vaccinate and (ii) If unfavorable reactions which each control shall be challenged by are attributable to the biological prod- eye-drop with a virulent bursal disease uct occur during the observation pe- virus provided or approved by Animal riod, the serial is unsatisfactory. If un- and Plant Health Inspection Service. favorable reactions occur in more than (i) Three to five days postchallenge, one of the controls or if unfavorable re- all vaccinates and controls shall be actions which are not attributable to necropsied and examined for gross le- the biological product occur in more sions of bursal disease as described in than two of the vaccinates, the test paragraph (b)(2)(i) of this section. shall be declared inconclusive and re- (ii) If at least 19 of 20, or 27 of 30, or peated, except that, if the test is not 36 of 40 vaccinates in each group are repeated, the serial shall be unsatisfac- not free from such lesions, the Master tory.

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(3) Virus titer requirements. Final con- group of control chickens shall be held tainer samples of completed product isolated from each other and from the shall be tested for virus titer using the vaccinates. titration method used in paragraph (ii) Twenty-one to 28 days (c)(2) of this section. To be eligible for postinoculation, blood samples shall be release, each serial and each subserial taken from each chicken and the serum shall have a virus titer sufficiently separated using a technique conducive greater than the titer of vaccine virus to virus preservation. These serums used in the immunogenicity test pre- shall be used as inocula in the com- scribed in paragraph (c) of this section plement fixation for avian lymphoid to assure that when tested at any time leukosis (COFAL) test prescribed in within the expiration period, each se- § 113.31. rial and subserial shall have a virus (iii) Serums from the vaccinates titer of 100.7 times greater than that shall be tested separately, but serums used in such immunogenicity test, but within each control group may be 2.0 not less than 10 titration units (PFU pooled. A valid test shall have positive or ID50’s) per dose. COFAL reactions from each virus in- [44 FR 60263, Oct. 19, 1979, as amended at 44 oculated group and negative reactions FR 67087, Nov. 23, 1979; 48 FR 33473, July 22, from the uninoculated controls. If any 1983. Redesignated at 55 FR 35562, Aug. 31, of the chickens injected with the Mas- 1990, as amended at 56 FR 66784, 66786, Dec. ter Seed have positive COFAL test re- 26, 1991; 64 FR 43045, Aug. 9, 1999; 72 FR 72564, actions in a valid test, the Master Seed Dec. 21, 2007] is unsatisfactory. § 113.332 Tenosynovitis Vaccine. (3) Identity using the following agar gel immunodiffusion test. The undi- Tenosynovitis Vaccine shall be pre- luted Master Seed may be used as test pared from virus-bearing cell culture antigen or the Master Seed may be in- fluids or embryonated chicken eggs. oculated onto the chorioallantoic Only Master Seed which has been es- membrane (CAM) of fully susceptible tablished as pure, safe, and immunogenic shall be used for pre- chicken embryos and the infected paring seeds for vaccine production. All CAMs ground and used as antigen. A serials of vaccine shall be prepared known tenosynovitis antiserum and a from the first through the fifth passage known tenosynovitis antigen shall be from the Master Seed. used in the test. A precipitin line shall (a) The Master Seed shall meet the form between the test antigen and the applicable general requirements pre- known antiserum in the center well scribed in § 113.300, except (a)(3)(ii) and which shows identity with the line (c), and the special requirements in formed between the antiserum and the this section. known antigen, or the Master Seed is (b) Each lot of Master Seed shall be unsatisfactory. tested for: (4) Safety using the following chick- (1) Pathogens by the chicken inocula- en test: tion test prescribed in § 113.36. (i) For vaccines intended for use in (2) Lymphoid leukosis virus contami- chickens less than 14 days of age, Mas- nation as follows: ter Seed equal to 10 label doses shall be (i) Each of at least 10 3-week-old or administered subcutaneously to each of older lymphoid leukosis free chickens 25 1-day-old tenosynovitis susceptible from the same source and hatch shall chickens. be injected intra-muscularly with an (ii) For vaccines intended for use amount of Master Seed equal to 100 only in chickens 14 days of age or label doses of vaccine. At least 15 older, Master Seed equal to 10 label chickens of the same source and hatch doses shall be administered shall be used as controls; 5 or more subcutaneously to each of 25 4-week-old shall be unvaccinated and serve as neg- or older tenosynovitis susceptible ative controls; 5 or more shall be in- chickens. jected with subgroup A lymphoid leu- (iii) The vaccinates shall be observed kosis virus; and 5 or more with sub- each day for 21 days. If unfavorable re- group B lymphoid leukosis virus. Each actions occur which are attributable to

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the vaccine, the Master Seed is unsat- (d) Test requirements for release. Each isfactory. If unfavorable reactions serial and subserial shall meet the ap- occur which are not attributable to the plicable general requirements pre- vaccine, the test is inconclusive and scribed in § 113.300, except (c), and the may be repeated. requirements in this paragraph. (c) Each lot of Master Seed shall be (1) Purity. Final container samples of tested for immunogenicity. The se- completed product from each serial lected virus dose shall be established as shall be tested for pathogens by the follows: chicken inoculation test prescribed in (1) Tenosynovitis susceptible chick- § 113.36. ens, of the same age and from the same (2) Safety. (i) Final container samples source shall be used as test birds. Vac- cines intended for use in very young of completed product from each serial chickens shall be administered to shall be safety tested as follows: chickens of the youngest age for which (A) For vaccines intended for use in the vaccine is recommended. Vaccines very young chickens, each of 25 1-day- intended for use in older chickens shall old tenosynovitis susceptible chickens be administered to 4-week-old or older shall be vaccinated with the equivalent chickens. Twenty or more vaccinates of 10 doses by one method rec- shall be used for each method of admin- ommended on the label. istration recommended on the label. (B) For vaccines intended for use in Ten or more chickens shall be held as older chickens, each of 25 4-week-old or unvaccinated controls. older tenosynovitis susceptible chick- (2) A geometric mean titer of the vac- ens shall be vaccinated with the equiv- cine produced at the highest passage alent of 10 doses by one method rec- from the Master Seed shall be estab- ommended on the label. lished using a method acceptable to (ii) The vaccinates shall be observed Animal and Plant Health Inspection each day for 21 days. If unfavorable re- Service before the immunogenicity actions occur which are attributable to test is conducted. A predetermined the product, the serial is unsatisfac- quantity of vaccine virus shall be ad- tory. If unfavorable reactions occur in ministered to each vaccinate. Five rep- more than two vaccinates which are licate virus titrations shall be conducted on an aliquot of the vaccine not attributable to the product, the virus to confirm the dose. test is inconclusive and may be re- (3) Twenty-one to 28 days peated. If the test is not repeated, the postvaccination, each vaccinate and serial is unsatisfactory. control shall be challenged by injecting (3) Virus titer requirements. Final con- virulent virus furnished or approved by tainer samples of completed product Animal and Plant Health Inspection shall be titrated by the method used in Service into one foot pad. The vac- paragraph (c)(2) of this section. To be cinates and controls shall be observed eligible for release, each serial and sub- each day for 14 days. If at least 90 per- serial shall have a virus titer suffi- cent of the controls do not develop ciently greater than the titer of the swelling and discoloration in the pha- vaccine virus used in the langeal joint area of the injected foot immunogenicity test prescribed in pad typical of infection with paragraph (c) of this section to assure tenosynovitis virus, the test is incon- that, when tested at any time within clusive and may be repeated. If at least the expiration period, each serial and 19 of 20, 27 of 30, or 36 of 40 vaccinates subserial shall have a virus titer 10 0.7 do not remain free from these signs, times greater than that used in the disregarding transient swelling which immunogenicity test, but not less than subsides within 5 days postchallenge, 10 2.0 titration units (PFU or ID ) per the Master Seed is unsatisfactory. 50 dose. (4) An Outline of Production change shall be made before authority for use (4) Identity. Bulk or final container of a new lot of Master Seed shall be samples of completed product from granted by Animal and Plant Health each serial shall be tested for identity Inspection Service. as prescribed in paragraph (b)(3) of this

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section and shall meet the criteria guinea pigs from one source which stated therein. weigh 500–700 grams at the beginning of the test and which have not been used [50 FR 438, Jan. 4, 1985. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR in a previous test. The comparison test 66784, 66786, Dec. 26, 1991; 64 FR 43045, Aug. 9, shall be conducted in accordance with 1999; 72 FR 72564, Dec. 21, 2007] the procedures prescribed in paragraphs (c)(1), (2), (3), (4), (5), (6), (7), and DIAGNOSTICS AND REAGENTS (8) of this section. (1) The guinea pigs shall be sensitized §§ 113.400–113.405 [Reserved] with a sterile heat-killed suspension of equal amounts of strains Pn, C, and Dt § 113.406 Tuberculin, Intradermic. of Mycobacterium tuberculosis. The heat- Tuberculin, Intradermic, is a filtrate killed sensitizing agent shall be in- produced from cultures of Pn, C, and jected in a volume of 0.5 ml per guinea Dt strains of Mycobacterium tuberculosis pig. The guinea pigs shall be considered (supplied by Animal and Plant Health sensitized for testing not less than 30 Inspection Service) which has been in- days nor more than 120 days post-injec- activated and is non-toxic. Each serial tion. shall be tested for purity, safety, po- (2) The guinea pigs shall be prepared tency, and special chemical tests in ac- for sensitivity testing at least 4 hours cordance with the conditions pre- prior to the injection of tuberculin. scribed for each test. A serial found un- The entire abdominal and flank areas satisfactory by any prescribed test shall be clipped, a depilatory agent ap- shall not be released. plied for 5–10 minutes, the area rinsed (a) Purity test. Each serial shall be with warm water, and dried. tested for purity as provided in this (3) Dilutions of 1:100, 1:200, and 1:400 paragraph. shall be prepared with the Reference (1) Final container samples of com- Tuberculin and the unknown tuber- pleted product shall be tested for via- culin. Three test sites on each side of ble bacteria and fungi as prescribed in and equidistant from the abdominal § 113.26. midline shall be chosen on each guinea (2) A 20 ml sample shall be pig. Using a tuberculin syringe and centrifuged and the sediment examined needle, 0.05 ml of each dilution shall be microscopically for the presence of injected intradermally at one of the acidfast (Ziehl-Nielsen stain) or other test sites which has been randomly se- microorganisms (Gram stain). A serial lected for the dilution. which contains microorganisms is un- (4) The sensitivity of the tuberculins satisfactory for release. shall be determined 24 hours after in- (b) Safety test. Final container sam- jected by measuring the area of ery- ples of completed product from each se- thema. Measurements in millimeters rial shall be tested for safety. Two ma- shall be made anterior of the greatest ture guinea pigs shall be injected diameter and perpendicular to the first subcutaneously with 1 ml and observed measurement. The square millimeter for 10 days. If unfavorable reactions at- shall be calculated by multiplying the tributable to the product occur during two measurements. the observation period, the serial is un- (5) The total area of response for each satisfactory. If unfavorable reactions tuberculin tested shall be determined occur which are not attributable to the by adding the areas of erythema for product, the test shall be declared in- each dilution of each of the test ani- conclusive and repeated: Provided, That mals in a group. The sums of the areas if the test is not repeated, the serial of erythema for all three dilutions of shall be declared unsatisfactory. each tuberculin shall be added to give (c) Potency test. Bulk or final con- the total area of tuberculin response. tainer samples of completed product (6) The total tuberculin response area from each serial shall be subjected to a of the serial being tested shall be ex- comparison test using a Reference Tu- pressed as a percentage of the total tuberculin supplied by Animal and Plant berculin response area of the Reference Health Inspection Service. Test ani- Tuberculin. (The total response area of mals shall be 10 sensitized white female the serial divided by the total response

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area of the Reference Tuberculin times (5) Clarity. The product shall be opti- 100.) cally clear and free from any extra- (7) If the total tuberculin response neous particles. area of the serial being tested does not [39 FR 16857, May 10, 1974. Redesignated at 39 fall between 75 percent and 125 percent FR 25463, July 11, 1974. Redesignated at 55 FR of the total tuberculin response area of 35561, Aug. 31, 1990, as amended at 56 FR the Reference Tuberculin, the serial is 66784, Dec. 26, 1991] unsatisfactory. § 113.407 Pullorum antigen. (8) Two unsensitized guinea pigs are given 0.05 ml intradermal injections of Pullorum Antigen shall be produced 1:4 and 1:10 dilutions of both the serial from a culture of representative strains being tested and the Reference Tuber- of Salmonella pullorum which are of known antigenic composition, high culin as a control for nonspecific posi- agglutinability, but are not sensitive tive reactions. If positive reactions are to negative and nonspecific serum. observed with the Reference Tuber- Each serial shall be tested for purity, culin, the test is considered a ‘‘No density, preservative content, sensi- Test’’ and repeated. If positive reactivity, homogeneity, and hydrogen ion tions are observed with the serial being concentration. A serial found unsatis- tested only, the serial is unsatisfac- factory by any prescribed test shall not tory. be released. (d) Special chemical tests and require- (a) Purity test. Final container sam- ments. Final container samples of com- ples of completed product shall be test- pleted product from each serial shall be ed for viable bacteria and fungi as pretested as follows: scribed in § 113.26. In addition, each se- (1) Hydrogen ion concentration. The rial shall be free from extraneous orga- hydrogen ion concentration shall be de- nisms as determined by Gram staining termined with a pH meter which has and microscopic examination. been standardized with a pH 7.0 buffer (b) Nephelometric determination of bac- just prior to use. The pH of the product terial density. The bacterial density ± shall be 7.0 ±0.3. shall be 80 15 times McFarland No. 1 standard for stained antigen K’s and 50 (2) Total nitrogen determination. The ±10 times McFarland No. 1 standard for nitrogen content shall be determined tube antigen. by the Kjeldahl method on duplicate 15 (c) Preservative requirements. (1) The ml samples consisting of 5 ml from formalin content of Pullorum Stained each of three vials. The total nitrogen Antigen K shall be 1.0 ±0.2 percent as content of the product shall be 0.18 per- determined by a colorimetric method. cent ±0.06 percent. (2) The phenol content for Pullorum (3) Trichloroacetic acid precipitable ni- Tube Antigen shall be 0.55 ±0.05 percent trogen. The determination of precipi- as determined by direct titration with table nitrogen by a final concentration a standardized bromide-bromate solu- of 4 percent trichloroacetic acid shall tion. be made by the Kjeldahl method on du- (d) Sensitivity requirements. (1) Each plicate 15 ml samples, consisting of 5 serial of antigen shall be compared ml from each of three vials. The with a reference antigen of known sen- trichloroacetic acid precipitable nitro- sitivity using positive and negative gen content shall be 0.047 percent ±0.01 chicken serum. The manufacturers’ percent. recommendations for use on the ac- (4) Phenol determination. The phenol companying label or package insert content shall be determined by direct shall be followed. The recommended time limit specified for each antigen titration with a standardized bromide- shall be carefully observed in the test. bromate solution. (A correction factor (2) A total of at least 12 serums shall of 0.04 should be subtracted from the be used. This shall include at least final value in the determination of phe- three definitely positive, at least three nol in tuberculin.) The phenol content weakly positive, and at least six nega- shall be 0.54 percent ±0.04 percent. tive serums. At least three positive chicken serums diluted with negative

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chicken serum shall be used to further ditions prescribed for each test. A se- assay comparative sensitivity between rial found unsatisfactory by any pretest and reference plate antigens. All scribed test shall not be released. test antigens shall agree closely with (a) Density requirements. A 2.5 ml sam- the reference antigen. Tests in which ple of completed antigen shall be di- variation of readings between the ref- luted with 2.5 ml of buffer solution for- erence and test antigen would result in mulated in the same manner as the ve- a different National Poultry Improve- hicle of the antigen being tested in a ment Plan classification shall be re- modified Hopkins tube and then garded as unsatisfactory. No unsatis- sedimented at 1,000×g in a refrigerated factory tests among the six or more centrifuge at 20 °C for 90 minutes. If negative serums and not more than one the packed cell volume of the com- unsatisfactory test among the six or pleted antigen is not 1.2 percent (±0.4 more positive serums shall be per- percent), the serial is unsatisfactory. mitted. All tests performed shall be in- (b) Preservative requirements. Preserv- cluded for evaluation of the sensitivity atives shall be as specified in the Out- assay. In the event of an unsatisfactory line of Production filed with APHIS in test using positive serums, at least accordance with 9 CFR 114.8. If phenol three additional definitely positive and is used, a direct titration with a stand- three additional weakly positive se- ardized bromide-bromate solution shall rums shall be tested. If not more than be made. If the final concentration of one unsatisfactory test is obtained phenol is not 0.25 percent (±0.05 per- with the additional serums, the anti- cent), the serial is unsatisfactory. gen shall be acceptable. (c) Homogeneity requirements. (1) Plate (e) Homogeneity requirement. Antigens antigen shall be checked on a plate for shall show no evidence of homogeneity and autoagglutination. If autoagglutination or unusual appear- plate antigen is not homogeneous and ance such as the presence of flakes, free of large visible particles (strands specks, or a preponderance of filament or clumps) or if it autoagglutinates, forms. Microscopic examination shall the serial is unsatisfactory. be made in this determination. (2) Stereo-microscopic examination (f) Hydrogen ion concentration. The shall be used when necessary to evalu- hydrogen ion concentration shall be de- ate a granular appearing antigen. termined with a pH meter which has (d) Hydrogen ion concentration. The been standardized with a pH 4.0 buffer hydrogen ion concentration shall be de- just prior to use. The pH of Pullorum termined with a pH meter which has Stained Antigen K shall be 4.6 ±0.4. No been standardized with a pH buffer just pH level is specified for Pullorum Tube prior to use. The pH of Mycoplasma Antigen but after dilution as rec- Gallisepticum Antigen shall be 6.0±0.2. ommended for use, it shall have a pH of The pH of Mycoplasma Synoviae Anti- 8.2 to 8.5. gen and Mycoplasma Meleagridis Anti- [39 FR 16857, May 10, 1974. Redesignated at 39 gen shall be 7.0±0.2. FR 25463, July 11, 1974, and amended at 40 FR (e) Purity requirements. The antigen 760, Jan. 3, 1975. Redesignated at 55 FR 35561, shall be tested for viable bacteria and Aug. 31, 1990] fungi as prescribed in § 113.26. (f) Sensitivity requirements. The reac- § 113.408 Avian mycoplasma antigen. tivity of each antigen shall be tested Mycoplasma antigens shall be pre- by comparing the agglutination reac- pared from organisms, grown in broth tions of each serial of antigen with the cultures, that are inactivated and agglutination reactions of a standard standardized. Plate antigens shall be reference antigen which is supplied by stained with a dye acceptable to Ani- or acceptable to APHIS. A set con- mal and Plant Health Inspection Serv- sisting of five known positive and five ice (APHIS). Final container samples known negative serums shall be used. of completed product from each serial The negative serums shall be tested shall be tested for density, preservative against the antigens undiluted and the content, homogeneity, hydrogen ion positive serums shall be tested against concentration, purity, sensitivity, and the antigens diluted 1:4 in buffer solu- specificity in accordance with the con- tion formulated in the same manner as

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the vehicle of the antigen being tested. rial shall be tested for safety as pre- If negative serums do not have nega- scribed in § 113.38. tive reactions in this test, the serial is (c) Potency test. Bulk or final con- unsatisfactory. If the test antigen and tainer samples of completed product the reference antigen do not have the from each serial shall be subjected to a same agglutination reactions with at comparison specificity test using a least four of the five positive serums Reference PPD Tuberculin supplied by used, the serial is unsatisfactory. Animal and Plant Health Inspection (1) The sensitivity of Mycoplasma Service. Gallisepticum Antigen shall be tested (1) Test animals. White female guinea using a set of chicken and a set of tur- pigs from one source, which weigh 500 key serums (the positive serums shall to 700 grams at the beginning of the have varying degrees of reactivity from test, and which have not been used in a weakly positive to strongly positive). previous test, shall be used in the spec- (2) The sensitivity of Mycoplasma ificity test. Twenty-three guinea pigs Synoviae Antigen shall be tested using (10 sensitized with M. bovis, 10 sen- chicken serums. sitized with M. avium and three (3) The sensitivity of Mycoplasma unsensitized) shall be required for each Meleagridis Antigen shall be tested serial being tested, and 20 guinea pigs using turkey serums. (10 sensitized with M. bovis and 10 sen- (g) Specificity requirements. Myco- sitized with M. avium) shall be required plasma Synoviae Antigen shall be ex- for the Reference PPD Tuberculin. Al- amined for cross-agglutination with lowance should be made for deaths dur- five Mycoplasma gallisepticum ing the sensitization period. antiserums (chicken origin); Myco- (2) Sensitization of guinea pigs. (i) Sen- plasma Meleagridis Antigen shall be sitize one group of guinea pigs to M. examined for cross-agglutination with bovis. Inject each animal five Mycoplasma gallisepticum intramuscularly with 0.5 ml of a sterile antiserums (turkey origin) and five heat-killed suspension of M. bovis Mycoplasma synoviae antiserums (tur- Strain AN–5 supplied by Animal and key origin). Tests shall be conducted Plant Health Inspection Service. with undiluted antigen. If cross-agglu- (ii) Sensitize one group of guinea pigs tination occurs, the serial is unsatis- to M. avium. Inject each animal factory. intramuscularly with 0.5 ml of a sterile heat-killed suspension of M. avium [48 FR 33474, July 22, 1983. Redesignated at 55 Strain D–4 supplied by Animal and FR 35561, Aug. 31, 1990, as amended at 56 FR Plant Health Inspection Service. 66784, Dec. 26, 1991] (iii) Maintain an unsensitized group as control animals. § 113.409 Tuberculin—PPD Bovis, (3) Thirty-five days post-injection, Intradermic. the guinea pigs shall be used for tuber- Tuberculin—PPD Bovis, Intradermic culin testing. is a purified protein derivative pro- (4) The sensitized animals and con- duced from cultures of Mycobacterium trols shall be prepared at least 4 hours bovis Strain AN–5 (supplied by Animal prior to injection of PPD tuberculin by and Plant Health Inspection Service), clipping the hair from the entire ab- which has been inactivated and is dominal and flank areas, applying a de- nontoxic. Each serial shall be tested pilatory agent for 5 to 10 minutes, then for purity, safety, potency, and special rinsing with warm water and drying. chemical characteristics in accordance (i) Select four sites on each guinea with the conditions prescribed for each pig for injection of PPD tuberculin. test. A serial found unsatisfactory by Two sites shall be on each side of the any prescribed test shall not be re- midline and spaced a sufficient dis- leased. tance from each other to avoid overlap- (a) Purity test. Each serial shall be ping of skin reactions. tested for viable bacteria and fungi as (ii) Prepare four dilutions of the Ref- prescribed in § 113.26. erence PPD Tuberculin and each serial (b) Safety test. Final container sam- of PPD tuberculin being tested so as to ples of completed product from each se- contain 0.6, 1.2, 2.4, and 4.8 micrograms

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of protein per 0.1 ml dose. Each of the Specificity index Classification four dilutions of the same tuberculin 440 mm 2 or greater ...... Satisfactory. shall be randomly assigned a site on a Between 360 mm 2 and 440 mm 2 ...... Inconclusive. guinea pig. Less than 360 mm 2 ...... Unsatisfactory. (iii) Inject one dose of each dilution at the assigned site using a tuberculin (11) Second stage test. If a serial is syringe. classified as inconclusive, it can be de- (5) Measurement of skin reactions. clared unsatisfactory or undergo a sec- Measure the area of erythema produced ond stage test. The second stage shall at each site on each guinea pig 24 hours be conducted in a manner identical to following injection of PPD tuberculin. the first stage, except that Measurements in millimeters shall be unsensitized guinea pig controls are made anterior to posterior across the not necessary. The results are evalu- greatest diameter and perpendicular to ated by combining the results obtained the first measurement. Calculate the on all guinea pigs tested in stages one area of erythema in square millimeters and two. Calculate the average re- at each site by multiplying the two sponse on the 20 M. bovis sensitized ani- measurements. mals and on the 20 M. avium sensitized (6) Calculation of average response per animals and determine the specificity guinea pig. Obtain the total area of ery- index. An inconclusive serial is satisfactory after the second stage test, if thema for each guinea pig by adding its specificity index is 400 square milli- the areas of the four test sites. Add meters or more, and unsatisfactory if these composite areas of erythema its specificity index is less than 400 from all guinea pigs with the same sen- square millimeters. sitization and the same PPD tuberculin (d) Special chemical tests and require- injection, then divide by the number of ments. Final container samples of com- animals in the group. The number ob- pleted product from each serial shall be tained is the average response per guin- tested as follows: ea pig to the PPD tuberculin for the (1) Protein concentration. The final given type of sensitization. product shall contain a protein con- (7) Determination of specificity index. centration of 1.0 ±0.1 mg/ml. The Micro- The specificity index of a PPD tuber- kjeldahl Test for Nitrogen shall be culin is determined by subtracting the used. average response obtained on M. avium (2) Phenol content. Phenol content of sensitized guinea pigs from the average the final product shall be 0.50 percent response obtained on M. bovis sen- plus or minus 0.04 percent. A direct ti- sitized guinea pigs. tration with a standardized bromide- (8) Validity of bioassay. The bioassay bromate solution shall be conducted. test results obtained on serials tested concurrently in a single test series are [41 FR 8471, Feb. 27, 1976, as amended at 41 valid if the specificity index of the ref- FR 21760, May 28, 1976; 41 FR 32883, Aug. 6, 1976. Redesignated at 55 FR 35561, Aug. 31, erence PPD tuberculin is at least 400 1990, as amended at 56 FR 66784, Dec. 26, 1991] square millimeters. If the results are not valid, the bioassay test series must ANTIBODY PRODUCTS be repeated with a different set of sensitized guinea pigs. § 113.450 General requirements for (9) Reactions in unsensitized guinea antibody products. pigs. If a positive reaction (erythema) Unless otherwise prescribed in a is observed in one or more of the 3 Standard Requirement or in a filed unsensitized guinea pigs, the serial is Outline of Production, all antibody unsatisfactory. products shall meet the applicable re- (10) Interpretation of specificity index. quirements of this section. When a bioassay is valid and reactions (a) Terminology. The following terms are not observed in unsensitized guinea in the regulations and standards con- pigs, the following interpretation of cerning antibody products shall mean: the specificity index will be used for Antibody. An immunoglobulin mol- classifying each serial of PPD tuber- ecule, having a precise glycoprotein culin: structure, produced by certain cells of

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the B lymphocyte lineage in response (c) Animals. All animals used in the to antigenic stimulation, and func- production of antibody products shall tioning to specifically bind and influ- be healthy. Their health status shall be ence the antigens that induced its syn- determined by physical examination thesis. by, or under the direct supervision of, a IgG (Immunoglobulin G). One of the licensed veterinarian and by tests for several recognized classes of struc- infectious diseases. Such animals shall turally related glycoproteins whose be maintained at licensed establish- representatives include all known anti- ments: Provided, That cows maintained bodies. at Grade A dairies (or the equivalent) Monoclonal. Produced by, or derived that are not injected with antigens for from, the offspring of a single common the purpose of stimulating the produc- progenitor cell. tion of specific antibodies and that are Failure of passive transfer. A condition used only for the purpose of supplying of neonates characterized by an abnor- lacteal secretions are exempt from mally low concentration of circulating being maintained at a licensed estab- maternal IgG. lishment. (b) Nomenclature. Antibody products (1) No animal shall be used while shall be named as follows: showing clinical signs of disease. The (1) Virus-specific products. The true presence of minor localized injuries or name of a virus-specific product shall: lesions (contusions, lacerations, burns, include the term ‘‘antibody,’’ specify etc.) without body temperature ele- the disease for which the product is in- vation and without significant pain tended, and indicate the type of animal and distress shall not be construed as that supplied the component anti- clinical evidence of disease. bodies. If the antibodies are (2) Before first use and on a regular monoclonal, the term ‘‘monoclonal’’ basis, all animals used in the manufac- shall be used. Example: ‘‘Duck Virus ture of antibody products shall be indi- Hepatitis Antibody, Duck Origin.’’ vidually subjected to applicable tests (2) Bacterium-specific products. The for infectious diseases. Records of all true name of a bacterium-specific prod- test results shall be maintained. An uct shall: include the term ‘‘antibody’’ animal which tests positive for an in- if the component antibodies are di- fectious disease shall not be used in the rected against a nontoxin antigen or manufacture of antibody products. the term ‘‘antitoxin’’ if the component Retests shall be conducted as deemed antibodies are directed against toxin, necessary by the Administrator. specify the organism against which the (i) Before first use, horses shall be product is intended, and indicate the tested as follows for: type of animal that supplied the com- (A) Equine infectious anemia (EIA) ponent antibodies. If the antibodies are at a laboratory approved by APHIS. monoclonal, the term ‘‘monoclonal’’ (B) Piroplasmosis, dourine, and glan- shall be used. Example: ‘‘Escherichia ders at the National Veterinary Serv- Coli Monoclonal Antibody, Murine Ori- ices Laboratories. gin.’’ (C) Brucellosis at a laboratory ap- (3) Failure of passive transfer products. proved by APHIS. Horses with standard The true name of a product for treat- agglutination titers of 1:50 or less can ment of failure of passive transfer shall be used for production. Horses with include the term ‘‘IgG’’ and indicate standard agglutination titers equal to the type of animal that supplied the or greater than 1:100 may be tested by component IgG. Example: ‘‘Bovine the Rivanol or card tests. Reactors to IgG.’’ these supplemental tests shall not be (4) Combination products. The true used for production. Nonreactors to the name of a product for treatment of fail- supplemental tests shall be retested ure of passive transfer as well as for after 30 days. If the supplemental tests the prevention and/or alleviation of a are negative and the agglutination specific viral or bacterial disease shall titer has not increased, the animal be named according to the nomen- may be used for production. Otherwise, clature prescribed above for virus-spe- the animal is unsatisfactory for this cific or bacterium-specific products. purpose.

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(ii) Horses shall be retested annually mal(s) shall be removed from the herd for EIA and, if housed or pastured with and the remaining animals retested. any other species, shall be retested an- Production shall not be renewed until a nually for brucellosis. negative herd test is obtained not less (iii) Before first use, cattle shall be than 28 days following removal of the tested as follows for: positive animal(s). (A) Tuberculosis by an accredited (vii) Negative animals shall be main- veterinarian: Provided, That cattle at tained separate and apart from untest- Grade A dairies supplying only lacteal ed or positive animals of any species. secretions need only be tested for tu- Production animals shall not be used berculosis in accordance with applica- for any other purpose, such as testing, ble Milk Ordinances or similar laws or work, or recreation. regulations. (d) Collection procedures. Blood, lac- (B) Brucellosis at a laboratory ap- teal secretions, and egg material shall proved by APHIS. Cattle with standard be collected as described in the filed agglutination titers of 1:50 or less can Outline of Production for the product. be used for production. Cattle with (e) Ingredient handling and processing. standard agglutination titers equal to Blood derivatives (serum, plasma, etc.), or greater than 1:100 may be tested by lacteal secretions, and egg material the Rivanol or card tests. Reactors to used in the production of antibody these supplemental tests shall not be products shall be subjected to an ap- used for production. Nonreactors to the propriate procedure for the inactiva- supplemental tests shall be retested tion of potential contaminating micro- after 30 days. If the supplemental tests organisms. The procedure shall be one are negative and the agglutination of those described below and specified titer has not increased, the animal in the filed Outline of Production for may be used for production; otherwise, the product: Provided, That another the animal is unsatisfactory for this procedure may be substituted if dem- purpose. Cattle at Grade A dairies sup- onstrated to be at least as effective by plying only lacteal secretions need not data acceptable to APHIS and specified be tested individually for brucellosis if in the filed Outline of Production for a portion of their secretions contribute the product. These data are expected to to the herd milk pool tested as re- come from a study comparing the ef- quired by the brucellosis ring test. An fectiveness of the established and sub- animal of a herd testing positive by stitute procedures against a satisfac- this test shall not be used in produc- tory battery of potential contami- tion. nating microorganisms. (iv) Cattle shall be retested annually (1) Blood derivatives of equine origin for both tuberculosis and brucellosis. shall be heated at 58.0–59.0 °C for 60 Cattle at Grade A dairies supplying minutes, and blood derivatives of bo- only lacteal secretions need only be vine, porcine, or other origin shall be tested for tuberculosis in accordance heated at 58.0–59.0 °C for 30 minutes. In with applicable Milk Ordinances or lieu of heat treatment, blood deriva- similar laws or regulations. Cattle at tives of any origin may be treated with Grade A dairies supplying only lacteal at least 2.5 megarads of ionizing radi- secretions need not be tested individ- ation, with a maximum radiation dos- ually for brucellosis if a portion of age specified in the filed Outline of their secretions contribute to the herd Production for the product. milk pool tested as required by the (2) Lacteal secretions shall be heated brucellosis ring test. An animal of a as described in paragraph (e)(1) of this herd testing positive by this test shall section, or shall be pasteurized at ei- not be used in production. ther 72 °C for 15 seconds or 89 °C for 1 (v) For other species, appropriate second using appropriate equipment. In tests and the frequency with which lieu of the heat treatment regimens they are applied shall be specified in prescribed, lacteal secretions may be the filed Outline of Production for the treated with at least 2.5 megarads of product. ionizing radiation, with a maximum ra- (vi) If a positive result is obtained on diation dosage specified in the Outline any prescribed test, the positive ani- of Production for the product.

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(3) Egg material shall be heated at (1) Dried products for parenteral ad- 58.0–59.0 °C for 30 minutes, or treated ministration and liquid products shall with at least 2.5 megarads of ionizing be tested as prescribed in § 113.26. radiation, with a maximum radiation (2) For dried products for oral admin- dosage specified in the filed Outline of istration, 10 final container samples Production for the product. shall be reconstituted with sterile (4) Blood derivatives, lacteal secre- water at the volume recommended on tions, and egg material shall not con- the label and tested for the following tain preservatives at the time of heat contaminants: treatment, and immediately after heat (i) Coliforms. One milliliter of each re- treatment shall be cooled to 7 °C or hydrated sample shall be pipetted into lower. a 100×15 mm petri dish and 10–15 ml of (5) Licensees shall keep detailed violet red bile agar at 45–50 °C added. records as to each batch treated and The plate shall be manipulated to coat each serial of product prepared for its entirety with the agar-sample mix- marketing. Recording charts shall bear ture and allowed to stand until the full information concerning the mate- mixture solidifies. The plate shall then rial treated and tests made of the be incubated at 35 °C for 24 hours. A equipment used for treatment. positive control plate and a negative (f) Preservatives. Liquid antibody control plate shall be prepared at the products, except those immediately same time and in the same manner as frozen following preparation and main- the plates containing samples of the se- tained in a frozen state until time of rial. All plates shall be examined at the use, shall contain at least one preserv- end of the incubation period. If char- ative from the following list, within acteristic growth is observed on the the range of concentration set forth: negative control plate, or no char- (1) Phenol 0.25 to 0.55 percent, or acteristic growth is observed on the (2) Cresol 0.10 to 0.30 percent, and/or positive control plate, the test shall be (3) Thimerosal 0.01 to 0.03 percent, or considered inconclusive and may be re- (4) Other preservative(s) specified in peated. If characteristic growth is ob- the filed Outline of Production for the served on any of the 10 plates con- product. taining samples of the serial, one (g) Antigens for hyperimmunization. If retest to rule out faulty technique may animals are hyperimmunized to gen- be conducted on samples from 20 final erate antibodies for a product for the containers. If characteristic growth is prevention and/or alleviation of a spe- observed on any of the retest plates, or cific infectious disease, and a USDA-li- if a retest is not initiated within 21 censed veterinary biological product is days of the completion of the original not employed for this purpose, the fol- test, the serial or subserial is unsatis- lowing shall apply: factory. (1) For each antigen, a Master Seed (ii) Salmonellae. One milliliter of each shall be established. rehydrated sample shall be pipetted (i) Bacterial Master Seeds shall be into a 100×15 mm petri dish and 10–15 tested for purity and identity as pre- ml of brilliant green agar at 45–50 °C scribed for live bacterial vaccines in added. The dish shall be manipulated § 113.64. to coat its entirety with the agar-sam- (ii) Viral Master Seeds shall be tested ple mixture and allowed to stand until for purity and identity as prescribed the mixture solidifies. The plate shall for live virus vaccines in § 113.300. then be incubated at 35 °C for 24 hours. (2) The maximum allowable passage A positive control plate and a negative level of the hyperimmunizing antigen control plate shall be prepared at the shall be the passage level of the anti- same time and in the same manner as gen used to generate product shown to the plates containing samples of the se- be efficacious and shall not exceed 10 rial. All plates shall be examined at the passages from the Master Seed. end of the incubation period. If char- (h) Purity tests. Final container sam- acteristic growth is observed on the ples of each serial and each subserial negative control plate, or no char- shall be tested for viable bacteria and acteristic growth is observed on the fungi as follows: positive control plate, the test shall be

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considered inconclusive and may be re- the negative control plate, or no peated. If characteristic growth is ob- growth is observed on the positive con- served on any of the 10 plates control plate, the test shall be considered taining samples of the serial, one inconclusive and may be repeated. If retest to rule out faulty technique may the average number of bacterial colo- be conducted on samples from 20 final nies on the 10 plates containing sam- containers. If characteristic growth is ples of the serial exceeds that specified observed on any of the retest plates, or in the filed Outline of Production for if a retest is not initiated within 21 the product, one retest to rule out days of the completion of the original faulty technique may be conducted on test, the serial or subserial is unsatis- samples from 20 final containers. If the factory. average number of bacterial colonies (iii) Fungi. One milliliter of each re- on the retest plates exceeds that speci- hydrated sample shall be pipetted into fied in the filed Outline of Production a 100×15 mm petri dish and 10–15 ml of for the product, or if a retest is not ini- appropriately acidified potato dextrose tiated within 21 days of the completion agar at 45–50 °C added. The plate shall of the original test, the serial or sub- be manipulated to coat its entirety serial is unsatisfactory. with the agar-sample mixture and al- (i) Safety tests. Bulk or final con- lowed to stand until the mixture solidi- tainer samples of each serial shall be fies. The plate shall then be incubated tested as prescribed in § 113.33(b). Dried at 20–25 °C for 5 days. A positive con- product shall be reconstituted as indi- trol plate and a negative control plate cated on the label and 0.5 ml injected shall be prepared at the same time and per mouse. in the same manner as the plates containing samples of the serial. All plates [61 FR 51774, Oct. 4, 1996] shall be examined at the end of the in- § 113.451 Tetanus Antitoxin. cubation period. If growth is observed on the negative control plate, or no Tetanus Antitoxin is a specific anti- growth is observed on the positive con- body product containing antibodies di- trol plate, the test shall be considered rected against the toxin of Clostridium inconclusive and may be repeated. If tetani. Each serial shall meet the appli- growth is observed on any of the 10 cable general requirements provided in plates containing samples of the serial, § 113.450 and paragraph (a) of this sec- one retest to rule out faulty technique tion, and be tested for potency as pro- may be conducted on samples from 20 vided in paragraph (b) of this section. final containers. If growth is observed Any serial found unsatisfactory by a on any of the retest plates, or if a prescribed test shall not be released. retest is not initiated within 21 days of (a) General requirements. The amount the completion of the original test, the of antitoxin in a final container shall serial or subserial is unsatisfactory. be the amount which is delivered from (iv) Total bacterial count. One milli- such container when opened and in- liter of each rehydrated sample, undi- verted until the flow stops. A grad- luted or diluted as prescribed in the uated volumetric cylinder which con- Outline of Production, shall be pipetted forms to the National Institute of into a 100×15 mm petri dish and 10–15 Standards and Technology require- ml of tryptone glucose extract agar at ments shall be used. The reading shall 45–50 °C added. The plate shall be ma- be made at the bottom of the meniscus. nipulated to coat its entirety with the Volumes of 10 ml or less shall be re- agar-sample mixture and allowed to corded to the nearest 0.1 and volumes stand until the mixture solidifies. The over 10 ml shall be recorded to the plate shall then be incubated at 35 °C nearest ml. for 48 hours. A positive control plate (1) All final containers of Tetanus and a negative control plate shall be Antitoxin shall yield not less than the prepared at the same time and in the labeled unitage of antitoxin through- same manner as the plates containing out the dating period. The minimum samples of the serial. All plates shall package size permitted for marketing be examined at the end of the incuba- in the United States shall be a 1,500 tion period. If growth is observed on unit vial.

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(2) The expiration date of Tetanus (5) Normal guinea pigs weighing Antitoxin shall be not more than 3 within a range of 340 to 380 grams shall years after the date of a potency test be used. Pregnant guinea pigs must not which demonstrates that the recover- be used. able antitoxin from the final container (i) Each of two guinea pigs (controls) provides at least 20 percent excess over shall be injected subcutaneously with a the number of units claimed on the 3 ml dose of the Standard Toxin-Anti- label or not more than 1 year after the toxin mixture. Injections shall be made date of a potency test which dem- in the same order that toxin is added onstrates that the recoverable anti- to the dilutions of antitoxins. These toxin from the final container provides shall be observed parallel with the ti- 10 to 19 percent excess over the number tration of one or more unknown of units claimed on the label. antitoxins. (b) Bulk or final con- Potency test. (ii) Two guinea pigs shall be used as tainer samples of completed product test animals for each dilution of the from each serial shall be assayed to unknown antitoxin. A 3.0 ml dose shall calculate the units of Tetanus Anti- be injected subcutaneously into each toxin in each final container. A comparative toxin-antitoxin neutralization animal. test shall be conducted using a stand- (6) Controls shall be observed until ard antitoxin and a standard toxin. All they are down and are unable to rise or dilutions shall be made in M/15 phos- stand under their own power. At this phate buffered (pH) 7.4 physiological time they are euthanized and the time saline with 0.2 percent gelatin. of death is recorded in hours. For a sat- (1) One ml of the Standard Antitoxin isfactory test, the controls must reach shall be diluted before use so the final this point with clinical signs of tetanus volume contains 0.1 unit per ml. The within 24 hours of each other and with- dilution shall be held at 20° to 25 °C for in an overall time of 60 to 120 hours. 30 minutes prior to combination with a The clinical signs to be observed are in- test does of toxin. creased muscle tonus, curvature of the (2) The Standard Toxin test dose is spine, asymmetry of the body outline that amount which when mixed with when the resting animal is viewed from 0.1 unit of Standard Antitoxin, incu- above, generalized spastic paralysis, bated at 20° to 25 °C for 1 hour, and in- particularly of the extensor muscles, jected subcutaneously into a 340 to 380 inability to rise from a smooth surface gram guinea pig, results in death of when the animal is placed on its side, that guinea pig within 60 to 120 hours or any combination of these signs. If with clinical signs of tetanus. The the control guinea pigs do not respond toxin shall be diluted so the test dose in this manner, the entire test shall be shall be in 2.0 ml. repeated. (3) A mixture of diluted Standard (7) Potency of an unknown antitoxin Toxin and diluted Standard Antitoxin is determined by finding the mixture shall be made so that 0.1 unit of anti- which will protect the test animal the toxin in 1 ml is combined with a test same as the Standard Toxin-Antitoxin dose of toxin. This Standard Toxin- mixture. Test animals dying sooner ° Antitoxin mixture shall be held at 20 than the controls indicate the unit ° to 25 C for 1 hour before injections of value selected in that dilution was not guinea pigs are made. present, whereas those living longer in- (4) A sample from each serial of anti- dicate a greater unit value. toxin shall be prepared as was the Standard Toxin-Antitoxin mixture; ex- [39 FR 16859, May 10, 1974. Redesignated at 39 cept the amount of antitoxin shall be FR 25463, July 11, 1974, and amended at 40 FR based on an estimation of the expected 760, Jan. 3, 1975; 40 FR 41996, Sept. 10, 1975; 43 potency. When testing is done on bulk FR 1479, Jan. 10, 1978; 50 FR 24905, June 14, material, the final container fill shall 1985. Redesignated at 55 FR 35561, Aug. 31, 1990; 61 FR 51776, Oct. 4, 1996; 64 FR 43045, reflect the endpoint value plus 10 per- Aug. 9, 1999] cent overage for 1 year dating and 20 percent overage for 3 year dating.

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§ 113.452 Erysipelothrix Rhusiopathiae Cumu- Cumu- lative Antibody. lative total total num- Erysipelothrix Rhusiopathiae Anti- Cumulative number of body is a specific antibody product con- Stage Number of vac- number of vac- ber of deaths cinates cinates deaths for an taining antibodies directed against one for a unsat- or more somatic antigens of satis- isfac- factory tory Erysipelothrix rhusiopathiae. Each serial test test shall be tested as provided in this section. Any serial found unsatisfactory 2 40 80 12 or 13 or less more. by a prescribed test shall not be released. (a) Each serial shall meet the appli- [39 FR 16859, May 10, 1974. Redesignated at 39 FR 25463, July 11, 1974, as amended at 40 FR cable general requirements provided in 20067, May 8, 1975; 40 FR 23989, June 4, 1975. § 113.450. Redesignated at 55 FR 35561, Aug. 31, 1990; 61 (b) Potency test. Bulk or final con- FR 51776, Oct. 4, 1996; 64 FR 43045, Aug. 9, tainer samples of completed product 1999] from each serial shall be tested using the two-stage test provided in this sec- § 113.453 [Reserved] tion. § 113.454 Clostridium Perfringens (1) In the first stage, each of 40 Swiss Type C Antitoxin. mice, each weighing 16 to 20 grams, Clostridium Perfringens Type C Anti- shall be injected subcutaneously with toxin is a specific antibody product 0.1 ml of product (dried product shall containing antibodies directed against be rehydrated according to label direc- the toxin of Clostridium perfringens tions). Twenty-four hours Type C. Each serial shall be tested as postinjection, the injected mice and 10 provided in this section. Any serial additional mice designated controls found unsatisfactory by a prescribed shall be challenged subcutaneously test shall not be released. with the same culture of Erysipelothrix (a) Each serial shall meet the appli- rhusiopathiae. cable general requirements provided in (2) If less than eight of the 10 con- § 113.450. trols die from erysipelas within 7 days (b) Potency test. Bulk or final con- post-challenge, the test is invalid. All tainer samples of completed product dead mice shall be examined to deter- from each serial shall be tested using mine if the cause of death was the toxin-neutralization test for Beta Erysipelothrix rhusiopathiae infection. Antitoxin provided in this section. (3) The mice injected with product Dried products shall be rehydrated ac- shall be observed for 10 days cording to label directions. postchallenge and all deaths recorded. (1) When used in this test, the fol- The second stage shall be required lowing words and terms shall mean: when 7–10 of the mice injected with (i) International antitoxin unit. (I.U.) product die in the first stage. The sec- That quantity of Beta Antitoxin which ond stage shall be conducted in a man- reacts with L0 and L∂ doses of Stand- ner identical to the first stage. ard Toxin according to their defini- (4) The results of the test shall be tions. evaluated according to the following (ii) L0dose. The largest quantity of table: toxin which can be mixed with one unit of Standard Antitoxin and not cause Cumu- sickness or death in injected mice. Cumu- lative lative total (iii) L∂dose. The smallest quantity of total num- toxin which can be mixed with one unit Cumulative number of Stage Number of vac- number of vac- ber of deaths of Standard Antitoxin and cause death cinates cinates deaths for an for a in at least 80 percent of injected mice. satis- unsat- (iv) Standard antitoxin. The Beta factory isfac- test tory Antitoxin preparation which has been test standardized as to antitoxin unitage on 1 40 40 6 or 11 or the basis of the International Clos- less more. tridium perfringens Beta Antitoxin

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Standard and which is either supplied toxin and 10 L∂ doses of Standard by or acceptable to Animal and Plant Toxin die, the results of the test are in- Health Inspection Service. The anti- conclusive and shall be repeated: Pro- toxin unit value shall be stated on the vided, That, if the test is not repeated, label. the serial shall be declared unsatisfac- (v) Standard toxin. The Beta toxin tory. preparation which is supplied by or is (iii) If any mice inoculated with the acceptable to Animal and Plant Health mixture of Clostridium Perfringens Inspection Service. Type C Antitoxin diluted 1:50 and 10 L0 (vi) Diluent. The solution used to doses of Standard Toxin die, the anti- make proper dilutions prescribed in toxin is considered to contain less than this test. Such solution shall be made 500 International Unit per ml and the by dissolving 1 gram of peptone and serial is unsatisfactory. 0.25 gram of sodium chloride in each 100 ml of distilled water; adjusting the pH [39 FR 16859, May 10, 1974. Redesignated at 39 FR 25463, July 11, 1974. Redesignated at 55 FR to 7.2; autoclaving at 250 °F. for 25 min- ° 35561, Aug. 31, 1990, as amended at 56 FR utes; and storing at 4 C. until used. 66784, Dec. 26, 1991; 61 FR 51777, Oct. 4, 1996] (2) The antitoxin content of the test sample shall be determined as follows: § 113.455 Clostridium Perfringens (i) Make a dilution of Standard Anti- Type D Antitoxin. toxin to contain 10 International Units Clostridium Perfringens Type D of antitoxin per ml. Antitoxin is a specific antibody prod- (ii) Make one dilution of Standard uct containing antibodies directed Toxin to contain 10 L doses per ml and 0 against the toxin of Clostridium make a second dilution of Standard perfringens Type D. Each serial shall be Toxin to contain 10 L∂ doses per ml. tested as provided in this section. Any (iii) Dilute 1 ml of the test sample serial found unsatisfactory by a pre- with 49 ml of diluent and combine 1 ml scribed test shall not be released. of this dilution with 1 ml of the Stand- (a) Each serial shall meet the appli- ard Toxin diluted to contain 10 L 0 cable general requirements provided in doses. § 113.450. (iv) Combine 10 International Units (b) Potency test. Bulk or final con- of Standard Antitoxin with 10 L0 doses of diluted Standard Toxin and combine tainer samples of completed product 10 International Units of Standard from each serial shall be tested using the toxin-neutralization test for Epsi- Antitoxin with 10 L∂ doses of diluted Standard Toxin. lon Antitoxin provided in this section. (v) Neutralize all toxin-antitoxin Dried products shall be rehydrated ac- mixtures at room temperature for 1 cording to label directions. hour and hold in ice water until injec- (1) When used in this test, the fol- tions of mice can be made. lowing words and terms shall mean: (vi) Five Swiss white mice, each (i) International antitoxin unit. (I.U.) weighing 16–20 grams, shall be used for That quantity of Epsilon Antitoxin each toxin-antitoxin mixture. A dose of which reacts with L0 and L∂ doses of 0.2 ml shall be injected intravenously Standard Toxin according to their defi- into each mouse. Conclude the test 24 nitions. hours post-injection and record all (ii) L0dose. The largest quantity of deaths. toxin which can be mixed with one- (3) Test Interpretation. (i) If any mice tenth unit of Standard Antitoxin and inoculated with the mixture of 10 not cause sickness or death in injected International Units of Standard Anti- mice. toxin and 10 L0 doses of Standard Toxin (iii) L∂dose. The smallest quantity of die, the results of the test are inconclu- toxin which can be mixed with one- sive and shall be repeated: Provided, tenth unit of Standard Antitoxin and That, if the test is not repeated, the se- cause death in at least 80 percent of in- rial shall be declared unsatisfactory. jected mice. (ii) If less than 80 percent of the mice (iv) Standard antitoxin. The Epsilon inoculated with the mixture of 10 Antitoxin preparation which has been International Units of Standard Anti- standardized as to antitoxin unitage on

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the basis of the International Clos- national Unit of Standard Antitoxin tridium perfringens Epsilon Antitoxin and 10 L∂ doses of Standard Toxin die, Standard and which is either supplied the results of the test are inconclusive by or acceptable to Animal and Plant and shall be repeated: Provided, That, if Health Inspection Service. The anti- the test is not repeated, the serial shall toxin unit value shall be stated on the be declared unsatisfactory. label. (iii) If any mice inoculated with the (v) Standard toxin. The Epsilon toxin mixture of Clostridium Perfringens preparation which is supplied by or is Type D Antitoxin diluted 1:34 and 10 L0 acceptable to Animal and Plant Health doses of Standard Toxin die, the anti- Inspection Service. toxin is considered to contain less than (vi) Diluent. The solution used to 34 International Units per ml and the make proper dilutions prescribed in serial is unsatisfactory. this test. Such solution shall be made [39 FR 16859, May 10, 1974. Redesignated at 39 by dissolving 1 gram of peptone and FR 25463, July 11, 1974, as amended at 40 FR 0.25 gram of sodium chloride in each 100 760, Jan. 3, 1975. Redesignated at 55 FR 35561, ml of distilled water; adjusting the pH Aug. 31, 1990, as amended at 56 FR 66784, Dec. to 7.2; autoclaving at 250 °F. for 25 min- 26, 1991; 61 FR 51777, Oct. 4, 1996] utes; and storing at 4 °C. until used. (2) The antitoxin content of the test §§ 113.456–113.498 [Reserved] sample shall be determined as follows: (i) Make a dilution of Standard Anti- § 113.499 Products for treatment of toxin to contain 1 International Unit of failure of passive transfer. antitoxin per ml. A product for the treatment of fail- (ii) Make one dilution of Standard ure of passive transfer (FPT) shall con- Toxin to contain 10 L0 doses per ml and tain a specified minimum quantity of make a second dilution of Standard IgG per dose and shall be recommended Toxin to contain 10 L∂ doses per ml. for use only in neonates of the same (iii) Dilute 1 ml of the test sample species as that of antibody origin. A with 33 ml of diluent and combine 1 ml product for oral administration shall of this dilution with 1 ml of the Stand- not be recommended for use in animals ard Toxin diluted to contain 10 L0 more than 24 hours of age, while one doses. for parenteral administration shall (iv) Combine 1 International Unit of only be recommended for use in neo- Standard Antitoxin with 10 L0 doses of natal animals. Each serial shall meet Standard Toxin and combine 1 Inter- the applicable general requirements national Unit of Standard Antitoxin provided in § 113.450 and be tested for with 10 L∂ doses of Standard Toxin. potency as provided in this section. (v) Neutralize all toxin-antitoxin Any serial found unsatisfactory by a mixtures at room temperature for 1 prescribed test shall not be released. hour, and hold in ice water until injec- (a) Qualification of an IgG Reference tions of mice can be made. Product. An IgG Reference Product (ref- (vi) Five Swiss white mice, each erence) shall be a serial of product that weighing 16–20 grams, shall be used for is manufactured according to the filed each toxin-antitoxin mixture. A dose of Outline of Production, properly quali- 0.2 ml shall be injected intravenously fied, and used to assess the potency of into each mouse. Conclude the test 24 subsequent product serials, as de- hours post-injection and record all scribed in paragraph (c) below. The ref- deaths. erence shall be qualified as follows: (3) Test Interpretation. (i) If any (1) At least 20 newborn, colostrum-de- mice inoculated with the mixture of 1 prived animals of the species for which International Unit of Standard Anti- the product is recommended shall be toxin and 10 L0 doses of Standard Toxin randomly selected. die, the results of the test are inconclu- (2) Blood samples shall be taken from sive and shall be repeated: Provided, each animal. That, if the test is not repeated, the se- (3) Each animal shall be administered rial shall be declared unsatisfactory. one dose of reference by the rec- (ii) If less than 80 percent of the mice ommended route and shall be observed inoculated with mixture of 1 Inter- for 24 hours.

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(i) Any adverse reactions shall be re- urements on both the reference and corded. two samples of the test serial, may be (ii) The dosage of reference adminis- conducted. If, upon retest, the average tered to each animal shall be in accord- IgG level per dose of the two samples of ance with label directions. Label direc- the test serial does not meet or exceed tions may indicate a single dosage re- that of the reference, or if a retest is gardless of weight, in which case the not conducted, the serial is unsatisfac- animals in the study shall be at or near tory. the maximum weight for neonates of [61 FR 51777, Oct. 4, 1996] the species. (4) After 24 hours, blood samples shall be taken from each animal. PART 114—PRODUCTION REQUIRE- (5) Pretreatment and post treatment MENTS FOR BIOLOGICAL PROD- serum IgG concentrations shall be con- UCTS currently determined for each animal using a radial immunodiffusion (RID) Sec. method acceptable to APHIS and de- 114.1 Applicability. scribed in the filed Outline of Produc- 114.2 Products not prepared under license. tion for the product. 114.3 Separation of establishments. (6) Concurrently, using the same 114.4 Identification of biological products. method, five IgG measurements shall 114.5 Micro-organisms used as seed. be made on an IgG Species Standard 114.6 Mixing biological products. supplied or approved by APHIS. The 114.7 Personnel at licensed establishments. IgG Species Standard shall be a prepa- 114.8 Outline of Production required. ration that contains IgG specific for 114.9 Outline of Production guidelines. 114.10 Antibiotics as preservatives. the species in question at a concentra- 114.11 Storage and handling. tion acceptable to APHIS. 114.12 Expiration date required. (7) For an IgG Reference Product to 114.13 Expiration date determination. be satisfactory, all animals used to 114.14 Extension of expiration date for a se- qualify the reference must remain free rial or subserial. of unfavorable product-related reac- 114.15 Disposal of unsatisfactory products tions and at least 90 percent of the and byproducts. paired serum samples must reflect an 114.16 Producing subsidiaries. increase in IgG concentration 114.17 Rebottling of biological products. (posttreatment minus pretreatment 114.18 Reprocessing of biological products. concentration) equal to or greater than AUTHORITY: 21 U.S.C. 151–159; 7 CFR 2.22, the IgG concentration of the IgG Spe- 2.80, and 371.4. cies Standard. SOURCE: 39 FR 16869, May 10, 1974, unless (b) Antibody functionality. Prior to li- otherwise noted. censure, the prospective licensee shall perform a neutralization study, or an- § 114.1 Applicability. other type of study acceptable to APHIS, to demonstrate functionality Unless exempted by regulation or of product antibody. otherwise authorized by the Adminis- (c) Potency. Bulk or final container trator, all biological products prepared, samples of completed product from sold, bartered or exchanged, shipped or each serial shall be tested for IgG con- delivered for shipment in or from the tent as provided in this paragraph. United States, the District of Colum- Samples of the test serial and of an IgG bia, any Territory of the United States, Reference Product established in ac- or any place under the jurisdiction of cordance with paragraph (a) of this sec- the United States shall be prepared in tion shall be concurrently tested for accordance with the regulations in this IgG content by the RID method re- part. The licensee or permittee shall ferred to in paragraph (a)(5) of this sec- adopt and enforce all necessary meas- tion. Five IgG measurements shall be ures and shall comply with all direc- made on each. If the IgG level per dose tions the Administrator prescribes for of the test serial does not meet or ex- carrying out such regulations. ceed that of the reference, one com- [52 FR 11026, Apr. 7, 1987, as amended at 56 plete retest, involving five IgG meas- FR 66784, Dec. 26, 1991]

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§ 114.2 Products not prepared under li- in legends filed in accordance with 9 cense. CFR part 108. A description of each (a) When an establishment license is State-licensed product must be filed issued, if biological products which with the Animal and Plant Health In- were not prepared in compliance with spection Service as part of the blue- the regulations are in the establish- print legends and must be sufficient for ment, such products shall not be Animal and Plant Health Inspection shipped or delivered for shipment or Service to determine any risk to the otherwise dealt with as having been production of other products in the li- prepared under such regulations. censed establishment and to determine (b) Except as provided in 9 CFR part that adequate procedures are followed 103, a biological product shall not be to prevent contamination during pro- prepared in a licensed establishment duction. unless the person to whom the estab- (3) Records in such establishments lishment license is issued holds an un- must be maintained in accordance with expired, unsuspended, and unrevoked §§ 116.1 and 116.2 of this subchapter and product license issued by the Adminis- shall include all products licensed by trator to prepare such biological product, or unless the products prepared the State or USDA. are subject to the provisions of § 107.2 (4) Reports prescribed in § 116.5 of this of this subchapter. subchapter for USDA-licensed estab- (c) A biological product produced in a lishments shall be submitted for all USDA-licensed establishment shall be veterinary biological products in the produced under a U.S. Veterinary Bio- establishment. logical Product License or a license (5) Under the following conditions, an granted by a State under § 107.2 (re- autogenous biologic may be produced ferred to as a State biological product in a USDA-licensed establishment license and the products prepared pur- under either a State or U.S. Veterinary suant thereto as State-licensed biologi- Biological Product License: cal products, including autogenous bio- (i) When a culture of microorga- logics), but not under both a U.S. Vet- nisms, isolated from a herd in a State, erinary Biological Product License and is received at a USDA-licensed estab- a State biological product license. Be- lishment that is in the same State but fore a U.S. Veterinary Biological Prod- that holds both a State and a U.S. Vet- uct License (including a conditional li- erinary Biological Products License for cense) is issued, the licensee shall re- autogenous biologics, the isolate shall linquish its State license for that prod- be designated by the licensee for use in uct: Provided, That autogenous bio- the production of an autogenous biologics shall not be subject to this pro- logical product under either the State vision when they are prepared in ac- product license, or the U.S. Veterinary cordance with the provisions of para- Biological Product License: Provided, graph (c)(5) of this section. (1) State-licensed biological products That the isolate meets the require- (including autogenous biologics) shall ments of the respective regulatory au- only be distributed or shipped intra- thority for an autogenous biologic. If, state, must not bear a U.S. Veterinary after producing the product pursuant Biologics Establishment License Num- to one license, the licensee elects to ber, and must not otherwise be rep- produce an autogenous biologic from resented in any manner as having met the same isolate under provisions of the requirements for a U.S. Veterinary the other license, the licensee may do Biological Product license. Labeling of so only with the approval of the other State- and USDA-licensed biological licensing authority. products produced in the same estab- (ii) The true name of a State-licensed lishment must be distinctly different autogenous biologic shall specify the in color and design. State of licensure: e.g. (2) All biological products in USDA- ‘‘ lllll Autogenous Bacterin’’ licensed establishments, whether licensed by USDA or by the State, shall (State) be prepared only in locations indicated or lllll Autogenous Vaccine’’.

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(State) in storage at licensed establishments: [39 FR 16869, May 10, 1974, as amended at 60 Provided, That, if such ingredients, FR 48021, Sept. 21, 1995] components, or biological products are not so identified, they shall be disposed § 114.3 Separation of establishments. of as provided in § 114.15. (a) Each licensed establishment shall be separate and distinct from any other § 114.5 Micro-organisms used as seed. establishment in which a biological Micro-organisms used in the prepara- product is prepared. tion of biological products at licensed (b) No biological products authorized establishments shall be free from the to be prepared in a licensed establish- causative agents of other diseases or ment shall be prepared in whole or in conditions. A complete record of such part by another licensed establishment micro-organisms shall be kept cur- except as provided in paragraphs (c) rently correct and a list submitted to and (d) of this section. Animal and Plant Health Inspection (c) When a partially prepared biologi- Service upon request of the Adminis- cal product cannot be completed at a trator. licensed establishment due to failure of essential equipment, the Administrator (Approved by the Office of Management and may authorize the use of similar equip- Budget under control number 0579–0059) ment at another licensed establish- [39 FR 16869, May 10, 1974, as amended at 48 ment: Provided, That, such authoriza- FR 57473, Dec. 30, 1983; 56 FR 66784, Dec. 26, tion shall be limited to the duration of 1991] the emergency and to the phase of production affected by the equipment fail- § 114.6 Mixing biological products. ure. Each biological product, when in liq- (d) Partially prepared products or se- uid form, shall be mixed thoroughly in rials of completed products for further a single container. During bottling op- manufacture may be moved from one erations, the product shall be con- licensed establishment to another li- stantly mixed sufficient to maintain censed establishment, imported under physical uniformity of the entire fill. A the provisions of § 104.5, or moved from a licensed establishment for purpose of serial number, with any other mark- being exported under conditions pre- ings that may be necessary for ready scribed in an Outline of Production identification of the serial, shall be ap- filed with Animal and Plant Health In- plied to identify it with the records of spection Service. Licensed products or preparation and labeling. products imported for distribution and sale may be prepared and recommended § 114.7 Personnel at licensed establishments. for final use, for further manufacturing purposes, or both. All serials shall be (a) Each licensee shall designate a subject to the requirements for testing person(s) to make all official contacts and release specified in § 113.5 or § 113.10 with Animal and Plant Health Inspec- and to the requirements for identification Service on matters pertaining to tion specified in § 114.4. the preparation of biological products under the Virus-Serum-Toxin Act. The [39 FR 16869, May 10, 1974, as amended at 40 FR 46093, Oct. 6, 1975; 49 FR 45846, Nov. 21, licensee shall file three copies of bio- 1984; 56 FR 66784, Dec. 26, 1991] graphical summary with Animal and Plant Health Inspection Service for § 114.4 Identification of biological such designated person and for each products. person responsible for any phase of Suitable tags or labels of a distinct preparation of a biological product. design shall be used for identifying all (b) All personnel employed in the ingredients used in the preparation of preparation of biological products at a biological products, all component licensed establishment shall be com- parts to be combined to form a biologi- petent in good laboratory techniques cal product, all biological products through education or training, or both, while in the course of preparation and so as to consistently prepare high qual- all completed biological products held ity products.

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(c) All biological products prepared ferred to as an approved outline, ap- at licensed establishments shall be pre- proval for filing constitutes no en- pared and handled with due sanitary dorsement by Animal and Plant Health precautions. Good sanitary measures Inspection Service of such biological shall be practiced at all times by all product or the methods and procedures personnel involved in such preparation used to prepare such biological prod- and handling of biological products. uct. (1) The clothing worn by persons (c) One copy of the Outline of Produc- while preparing biological products tion shall be retained by the Animal shall be clean. All persons, imme- and Plant Health Inspection Service diately before entering laboratory and one copy returned to the licensee rooms of a licensed establishment, shall change their outer clothing or ef- or permittee. fectively cover the same with gowns or (d) Each licensee shall review each other satisfactory clean garments. Outline of Production for accuracy and (2) Unsanitary practices such as, but sufficiency not less frequently than not limited to, eating, smoking, or ex- once a year. Revisions necessary to pectorating on the floors or otherwise bring an Outline of Production into creating a nuisance in any room, com- compliance with the regulations shall partment, or place in which biological be submitted to Animal and Plant products are prepared, handled, or Health Inspection Service. stored at licensed establishments are (e) When a list of licensed products to prohibited. be continued in production at a li- (Approved by the Office of Management and censed establishment is requested by Budget under control number 0579–0013) the Administrator in accordance with [39 FR 16869, May 10, 1974, as amended at 48 § 102.5(d) of this subchapter, the li- FR 57473, Dec. 30, 1983; 56 FR 66784, Dec. 26, censee shall supplement the list with 1991] information for each product as follows: § 114.8 Outline of Production required. (1) The Outline of Production cur- An Outline of Production shall be on rently being used shall be identified as file with Animal and Plant Health In- to the date when last revised and filed spection Service for each licensed bio- with Animal and Plant Health Inspec- logical product or for each biological tion Service and the date of the last re- product authorized to be imported into view made by the licensee. the United States for Distribution and (2) The Outline of Production to be Sale. Preparation of a biological prod- kept in the active file shall be des- uct in a licensed establishment shall be ignated. If more than one has been filed in accordance with the Outline of Pro- for a product, only the Outline of Pro- duction for such product filed with duction currently being used shall be Animal and Plant Health Inspection included. Service as provided in this section, but subject to changes as may be required (f) The Administrator may, upon the under § 114.8(f). basis of information not available to (a) The Outline of Production shall him at the time the current Outline of be prepared as prescribed in § 114.9 and Production for a biological product was submitted to Animal and Plant Health filed, object to the methods or proce- Inspection Service for filing. When ob- dures being used in the preparation of jectionable features, if any, are cor- such biological product and notify the rected and no further exceptions are licensee to modify the filed Outline of taken by Animal and Plant Health In- Production to eliminate such objec- spection Service to an Outline of Pro- tions. If the licensee does not comply duction for a biological product, such with the notice, the Administrator Outline of Production shall be ap- may, after affording opportunity for a proved for filing. hearing to the licensee, suspend the (b) Each page shall be stamped as product license for the biological prod- filed on the date such action was taken uct involved; in which case, the li- in the bottom right hand corner. Al- censee shall not prepare such product though the filed outline may be re- until subsequent notice of withdrawal

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of the suspension is given to the lion the Internet at (http:// censee. www.aphis.usda.gov/animallhealth/ vet biologics/vb forms.shtml). (Approved by the Office of Management and l l Budget under control number 0579–0013) (b) Special outline. An outline describing the preparation of a component of [39 FR 16869, May 10, 1974, as amended at 48 a biological product or an operation FR 57473, Dec. 30, 1983; 56 FR 66784, Dec. 26, 1991; 75 FR 20773, Apr. 21, 2010] performed in the preparation of a biological product may be required if such § 114.9 Outline of Production guide- special outline could be referred to in lines. Outlines of Production to eliminate Each Outline of Production shall be repetition. Each special outline shall prepared in accordance with the appli- be identified by number and shall not cable directions provided in this sec- be used until accepted and filed by Ani- tion. mal and Plant Health Inspection Serv- (a) General requirements. (1) All copies ice. of each Outline of Production or spe- (c) Outline of Production for anti- cial outline or revised pages of either serum, antitoxin, and normal serum shall be prepared on heavy paper shall be written according to the fol- (8.5″ x11″) of a type receptive to perma- lowing: nent stamp ink. OUTLINE GUIDE FOR PRODUCTION OF ANTI- (2) The name of the biological prod- SERUM AND ANTITOXIN AND NORMAL SERUM uct (or component), the establishment license number, and the date prepared License No. Name of Product Date shall appear on a front cover page and I. Serum animals. A. Species, conditions, each page of the Outline of Production age, and general health. B. Examination, preparation, care, quar- or special outline. The name of the li- antine, tests, and treatment of animals be- censee (or foreign manufacturer) shall fore injections are started. appear on the front cover page. C. Holding, handling, exercising, and moni- (3) The pages shall be numbered in toring the condition of animals after injec- the upper center. At least 11⁄2 inch mar- tions are started. gin shall be left at the top of the first II. Antigens. A. Composition and character page and a 2 inch margin at the bottom of the antigen. 1. Micro-organisms. of each page for the Animal and Plant 2. Source and date of accession of each Health Inspection Service stamp. micro-organism. (4) Amended pages shall be numbered 3. Strains. the same as those being superseded. 4. Proportions of each micro-organism and They shall bear the date prepared and strain. refer to the date on the pages being su- B. Identification methods used for each perseded. If one replacement page su- micro-organism and frequency with which these methods are applied. persedes more than one page, the new C. Virulence and purity of cultures or anti- page shall indicate same, but if several gen and the determination and maintenance replacement pages are added to super- thereof. Range of subcultures or passages to sede one page, the page number fol- be used in production. lowed by letters shall be used. D. Attenuation, if any, before use for pro- (5) The last page of both copies of ei- duction purposes. ther a new or a completely rewritten E. Character, size, and shape of containers Outline of Production and each page used for growing micro-organisms. F. Media used for stock, seed, and antigen revised separately shall be signed in cultures (composition and reaction of). May the lower left corner by the authorized refer to a special outline by number. representative of the licensee (or for- G. Preparation of the antigen or toxin and eign producer). Stamped or facsimile toxoid. Complete and full description of each signatures are not acceptable. step and its manner of accomplishment and (6) A summary of changes shall ap- number these steps in sequence. Include all pear on an attached page and refer to tests for each antigen, and the specifications each page, paragraph, or subparagraph for character, identity, virulence, concentration, and standardization. being changed. III. Immunization of animals. A. Outline (7) Transmittal forms shall be used fully with special attention given to the fol- for the original and subsequent revi- lowing: sions. Transmittal forms are available 1. Character and dose of the antigen.

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2. Method and frequency of injections. I. Composition, etc., of the product. A. Micro- 3. Time required for immunization or organisms used. Give the isolation and pas- hyperimmunization. sage history. 4. Preliminary bleedings and tests, if any, B. Source and date of accession of each to ascertain quality of serum. micro-organism. 5. All other similar matters, including C. Strains. treatments between bleedings. D. Proportions of each strain. B. Period of time elapsing between last in- II. Cultures. A. Brief description of methods jection and first bleeding; and between bleed- of identifying each micro-organism and the ings. frequency with which these methods are ap- C. Technique of bleeding operations; vol- plied. ume of blood collected at each bleeding; and B. Virulence and purity of cultures and the period of rest. determination and maintenance thereof. IV. Preparation of the biological product. A. Range of subcultures or passages to be used Describe fully and show each step of prepara- in production. tion from the first bleeding to the comple- C. Composition and reaction of media used tion of the preserved product in bulk con- for seed and production cultures. Include the tainers prior to filling of final containers. source of eggs, tissue, or cell cultures, and B. Composition of the preservative and the tests to determine that eggs, tissues, and proportions used. Indicate at which step of cells are free of contamination. production, and the method used in adding D. Character, size, and shape of containers the preservative. used for growing cultures. C. Agglutination and complement-fixation E. Storage conditions of seed cultures. titers and the methods of their determina- F. Methods of preparing suspensions for tions. seeding or inoculation. D. Disposition of unsatisfactory biological G. Technique of inoculating (1) seed media; products and infective materials not used in (2) production media. Titer or concentration production. of inoculum, and the volume of medium for E. Assembly of units to make a serial; vol- each size and type of culture container. ume of the average serial; and the volume of H. Period of time and conditions for incu- the maximum serial. bation and degree of temperature used for V. Testing. Indicate the stages in the prepa- each micro-organism or group of micro-orga- ration of the biological product at which nisms. samples are collected. Refer to all applicable I. Character and amount of growth; obser- Standard Requirements. Outline all addi- vation as to contamination of growth. tional tests in detail and state minimum re- J. Method of attenuation, if any, before quirements for each satisfactory test. used for production purposes. A. Purity. III. Harvest. A. Handling and preparation of B. Safety. cultures and media (including eggs) before C. Potency. removal of micro-organisms or tissues for D. Other tests. production purposes. VI. Post preparatory steps. B. Minimum and maximum period of time A. Form and size of final containers in elapsing from time of inoculation until har- which the product is to be distributed. vest. B. Methods and techniques of filling final C. Technique of harvesting micro-orga- containers. Volume of fill for each size final nisms or tissues (specify) for production pur- container. poses. C. Collection, storage, and submission of D. Specifications for acceptable harvest representative samples. Indicate at which material. steps in the production these samples are E. Handling of discarded material not used taken. in production. D. Expiration date based on the earliest F. Include any additional pertinent infor- date of harvest and the date of the last satis- mation. factory potency test. IV. Preparation of the product. Describe E. Use, dosage, and route of administration fully and show each step of preparation from for each animal species for which it is rec- harvest of antigen containing tissues or pro- ommended. duction cultures to the completion of the F. Include any additional pertinent infor- finished product in final containers. In de- mation. scribing the preparation of the product, em- (d) Outline of Production for vaccines, phasize the following: A. Method of inactivation, attenuation, or bacterins, antigens, and toxoids shall be detoxification. written according to the following: B. Composition of preservative, adjuvant or stabilizer, and proportions used stated in OUTLINE GUIDE FOR VACCINES, BACTERINS, such a manner that the concentration can be ANTIGENS, AND TOXOIDS calculated; stage and method of addition. License No. Name of Product Date C. Method and degree of concentration.

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D. If product is standardized to give con- 7. Method and technique of filling and seal- centration of antigen, show procedures and ing of final containers. calculations. 8. Amount material per dose or doses in E. 1. Assembly of units to make a serial (il- final container. lustrate by example). III. Testing. Indicate the stages in the prep- 2. Volume of average serial. aration of the biological product at which 3. Volume of maximum serial. the samples are collected. Refer to all appli- 4. Any other pertinent information. cable Standard Requirements. Outline all ad- F. Volume of fill for each size vial. Type of ditional tests in detail and state the min- vial if unusual. imum requirement for each satisfactory test. G. Method and technique of filling and A. Purity. sealing of final containers. B. Safety. H. Desiccation, including moisture control. C. Potency. Give maximum percent moisture. D. Any other tests. I. Amount of antigenic material per dose E. Include any additional pertinent infor- or doses in final container. mation. V. Testing. Indicate the stages in the prepa- IV. Post preparatory steps. A. Form and size ration of the biological product at which the of final containers in which the product is to samples are collected. Refer to all applicable be distributed. Standard Requirements. Outline all addi- B. Collection, storage, and submission of tional tests in detail and state the minimum representative samples. Indicate at which requirement for each satisfactory test. steps in the production these samples are A. Purity. taken. B. Safety. C. Expiration date based on the earliest C. Potency. date of harvest and the date of the last satis- D. Moisture, if desiccated. factory potency test. E. Any other tests. D. Use, dosage, and route of administration VI. Post preparatory steps. A. Form and size of final containers in which the product is to for each animal species for which the bio- be distributed. logical product is recommended. B. Collection, storage, and submission of (f) Outlines of Production for diag- representative samples. Indicate at which nostic test kits based on antigen-anti- steps in the production these samples are body reactions, and other diagnostics taken. C. Expiration date based on the earliest whose production methods are ame- date of harvest and the date of the last satis- nable to description as described herein factory potency test. If applicable, give the shall be written according to the fol- date of lyophilization. lowing requirements: D. Use, dosage, and route of administration for each animal species for which the bio- OUTLINE GUIDE FOR DIAGNOSTIC TEST KITS logical product is recommended. License No. Name of product Date (e) Outlines of Production for allergenic extracts shall be written accord- Introduction ing to the following: Provide a brief description of the kit as follows: OUTLINE GUIDE FOR ALLERGENIC EXTRACTS 1. Principle of the test (ELISA, latex ag- License No. Name of Product Date glutination, etc.). 2. Antigen or antibody detection test. I. Composition of the product. A. Source and 3. Sample(s) used for testing (serum, whole type of raw material. blood, tears, etc.). B. Weight/volume concentration. II. Preparation of the product. A. Describe 4. List reagents, references, and equipment fully and show each step of preparation to included. the completion of the finished product in 5. Identify materials obtained under split true containers. In describing the prepara- manufacturing agreements. tion of the product, emphasize the following: 6. General description of test interpreta- 1. Method of extraction. tions and their limitations, including fol- 2. Composition of preservative, adjuvant or lowup tests. stabilizer, and proportions used; stage and I. Antibody Components method of addition. 3. Method and degree of concentration. A. Production of polyclonal antibody com- 4. Standardization of the product. ponents. 5. (a) Assembly of units to make a serial. 1. If purchased, list suppliers, criteria for (b) Volume of average serial. acceptability, and describe all tests per- (c) Maximum serial. formed after receipt to determine that speci- 6. Volume of fill for each size vial. fications have been met.

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2. If produced in-house, describe the spe- d. Describe all characterization procedures cies, age, weight, conditions, and general and include the expected reactivity of all ref- health of all animals used in antiserum pro- erence monoclonal antibodies. duction. a. Preinjection considerations: II. Antigen Preparation Describe the examination, preparation, A. Identify the microorganism(s) or anti- care, quarantine procedures, and treatments gen being used. If previously approved Mas- administered before immunization(s). De- ter Seed virus, bacteria, or antigen derived scribe all tests used to determine suitability therefrom is used, provide pertinent infor- for use. Describe the preparation of any mation on the testing performed, and details standard negative serum(s) collected prior to immunization. of dates of United States Department of Ag- b. Immunization of animals. riculture confirmatory tests and approval, as i. Describe the character and dose of the appropriate. antigen; if adjuvant is used provide details B. Describe all propagation steps, includ- on its preparation. If commercial product is ing identification of cell cultures, media in- used include its true name as shown on the gredients, cell culture conditions, and har- label, the manufacturer, serial number, and vest methods. For antigen produced in eggs, expiration date. give the egg source, age, and route of inocu- ii. Describe the method and schedule for lation. If cell lines are being used, give dates immunizations. of testing and approval as specified in 9 CFR iii. Describe the method for harvesting and 113.52. evaluating the immunization product, in- C. Describe procedures used for extracting cluding tests for acceptability. and characterizing the antigen. iv. Provide number and intervals between D. Describe the method used to standardize harvests, volume obtained, and any other the antigen. pertinent information. E. If the antigen is purchased, identify the B. Production of Monoclonal Antibody supplier and describe the criteria for accept- Components. able material, including all tests performed 1. Hybridoma components: by the producer and/or the recipient to deter- a. If hybridoma components are purchased, mine acceptability. list suppliers and criteria for acceptability; if tests are performed after receipt, describe III. Preparation of Standard Reagents fully. b. If hybridomas are prepared inhouse, A. Describe the positive and negative con- identify the antigen(s) used, describe the im- trols included in the kit. If purchased, list munization scheme, and the species of ani- suppliers and criteria for acceptance. mal used. B. Describe the preparation and standard- c. Identify the tissue of origin, and the pro- ization of the conjugate(s). If purchased, list cedures for harvesting, isolating, and identi- suppliers and criteria for acceptance. fying the immune cells. C. Describe the preparation and standard- d. Describe the source, identity, and the ization of the substrate(s). If purchased, list product secreted (light or heavy chain) by suppliers and criteria for acceptance. the parent Myeloma Cell Line. D. Identify buffers, diluents, and other re- e. Summarize cloning and recloning proce- agents included in the kit. The preparation dures, including clone characterization and of these components may be described in this propagation, if appropriate. section or in filed Special Outlines. f. If appropriate, describe procedures for establishing and maintaining seed lots. IV. Preparation of the Product g. Describe any other pertinent tests or Fully describe methods used to standardize procedures performed on the hybridoma cell antigens, reference standards, positive con- line. trol serum, negative control serum, and 2. Antibody production: standard reagents from production/purchase a. Describe the production method. If pro- to completion of finished product in final duced in cell culture, animal serum additives containers, including the following: must conform to 9 CFR 113.53. If produced in animals, describe fully including husbandry 1. Composition and quantity of preserva- practices and passage procedures. tive in each. b. Provide the criteria for acceptable 2. Method of filling, plating, or attaching monoclonal antibody, including tests for pu- the antigen or antibody component to a solid rity. phase. c. Describe all tests or other methods used 3. Minimum and maximum acceptable fill to ensure uniformity between production volumes for each final container of reagent lots of monoclonal antibody. Include all re- included in the kit. action conditions, equipment used, and reac- 4. The disposition of unsatisfactory mate- tivity of the component. rial.

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V. Testing ological product, when prepared as rec- Refer to all applicable standard require- ommended for use, shall not exceed the ments. amounts listed in this paragraph: Pro- A. Purity. vided, That in the case a desiccated bio- Describe all tests of the kit for purity or logical product is to be used with an in- specify the exemption as provided in 9 CFR definite quantity of water or other 113.4. menstruum, the determination shall be B. Safety. In vitro products are exempt from safety based on 30 ml. per 1,000 dose vial or tests. equivalent. C. Potency. (2) Except as prescribed in paragraph Provide details of tests used to determine (c) of this section, only one antibiotic the relative reactivity of the kit including shall be used as a preservative in a bio- minimum requirements for a satisfactory logical product. The kind and max- test. Reference standards and control serum used for this purpose should be identified by imum amount per ml. of such anti- unique codes or lot numbers. biotic shall be restricted to: Amphotericin B ...... 2.5 mcg. VI. Postpreparatory Steps Nystatin (Mycostatin) ...... 30.0 units A. Describe the form and size of final con- Tetracyclines ...... 30.0 mcg. tainers of each reagent/component included Penicillin ...... 30.0 units in the kit. Streptomycin ...... 30.0 mcg. B. Describe the collection, storage, and Polymyxin B ...... 30.0 mcg. submission of representative samples. Refer Neomycin ...... 30.0 mcg. to 9 CFR 113.3(b)(7). Gentamicin ...... 30.0 mcg. C. Specify the expiration date. Refer to 9 (c) Permitted combinations: CFR 114.13. (1) Penicillin and streptomycin. D. Provide details of recommendations for use, including all limitations, qualifications, (2) Either amphotericin B or nys- and interpretation of results. tatin, but not both, may be used with E. Submit confidentiality statement iden- one of the other antibiotics listed in tifying specific parts of the outline con- paragraph (b) of this section, or with a taining information, the release of which combination of penicillin and strepto- would cause harm to the submitter. mycin, or with a combination of poly- (Approved by the Office of Management and myxin B and neomycin. Budget under control number 0579–0013) (3) The maximum amount of each an- [39 FR 16869, May 10, 1974, as amended at 48 tibiotic in a combination shall be the FR 57473, Dec. 30, 1983; 56 FR 20124, May 2, amount prescribed for such antibiotic 1991; 56 FR 66784, Dec. 26, 1991; 75 FR 20773, in paragraph (b) of this section. Apr. 21, 2010] (d) Antibiotics used in virus seed stock purification are not restricted as § 114.10 Antibiotics as preservatives. to kind or amounts provided carryover Antibiotics are authorized for use as into the final product is controlled and preservatives for biological products if specified in outlines of production. used within the limitations as to kinds and amounts prescribed in this section. [39 FR 16869, May 10, 1974, as amended at 56 (a) When an antibiotic or combina- FR 66784, Dec. 26, 1991] tion of antibiotics, with or without a fungistat is to be used in the prepara- § 114.11 Storage and handling. tion of a biological product, the kind(s) Biological products at licensed estab- and amount(s) of each shall be speci- lishments shall be protected at all fied in the outline for such product in times against improper storage and such a way that the concentration in handling. Completed product shall be the final product may be calculated. kept under refrigeration at 35 °to 45 °F. Except as may be approved by the Ad- (2 °to 7 °C.) unless the inherent nature ministrator, only those individual anti- of the product makes storage at a dif- biotics or combinations of antibiotics ferent temperature advisable, in which listed in paragraphs (b) and (c) of this case, the proper storage temperature section shall be used. shall be specified in the filed Outline of (b) Permitted individual antibiotics: Production. All biological products to (1) The antibiotic level of a specified be shipped or delivered shall be se- individual antibiotic in one ml. of a bi- curely packed.

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§ 114.12 Expiration date required. shipped from one licensed premises to Each serial or subserial of biological another licensed premises shall be ex- product prepared in a licensed estab- empt from this requirement. lishment shall be given an expiration (3) For a serial or portion of a serial date determined in accordance with the if the expiration date has been ex- requirements provided in § 114.13 or tended previously, unless otherwise au- § 114.14. A licensed biological product thorized in accordance with § 114.1. shall be considered worthless under the (b) An extension of the expiration Virus-Serum-Toxin Act subsequent to date may be granted by Animal and the expiration date appearing on the Plant Health Inspection Service if a re- label. quest from the licensee is substantiated by valid test data which dem- [41 FR 44687, Oct. 12, 1976] onstrate the potency of the product meets or exceeds the requirements for § 114.13 Expiration date determina- release. The new expiration date shall tion. be calculated from the date the latest Unless otherwise provided for in a satisfactory potency test was initiated. Standard Requirement of filed Outline The extension of the expiration date of Production, the expiration date for shall not exceed the maximum dating each product shall be computed from allowed in the filed Outline of Produc- the date of the initiation of the po- tion. tency test. Prior to licensure, stability (1) Serials are approved for redating of each fraction shall be determined by under the condition that Animal and methods acceptable to Animal and Plant Health Inspection Service may Plant Health Inspection Service. Expi- require the firm to retest the redated ration dates based on this stability serial for potency during the extended data shall be confirmed as follows: dating period and if found unsatisfac- (a) Products consisting of viable orga- tory require it be removed from the nisms. Each serial shall be tested for market by the licensee. potency at release and at the approxi- (2) [Reserved] mate expiration date until a statistically valid stability record has been [50 FR 24903, June 14, 1985, as amended at 56 established. FR 66784, Dec. 26, 1991] (b) Nonviable biological products. Each § 114.15 Disposal of unsatisfactory serial presented in support of licensure products and byproducts. shall be tested for potency at release and at or after the dating requested. All biological products found to be (c) Subsequent changes in the dating unsatisfactory for marketing, all bio- period for a product may be granted, logical products which have become based on statistically valid data sub- worthless subsequent to the expiration mitted to support a revision of the Out- date, all refuse, other materials line of Production. deemed unsatisfactory for production purposes, all carcasses (part or whole) [50 FR 24903, June 14, 1985, as amended at 56 of production or test animals, and any FR 66784, Dec. 26, 1991] undesirable byproducts of manufacture § 114.14 Extension of expiration date shall be disposed of as may be required for a serial or subserial. by the Administrator. (a) Unless otherwise provided for in a [41 FR 44687, Oct. 12, 1976, as amended at 56 filed Outline of Production for the FR 66784, Dec. 26, 1991] product, the expiration date shall not be extended: § 114.16 Producing subsidiaries. (1) If all fractions of the product are A serial or subserial of a biological not evaluated for potency by tests des- product may be produced jointly by a ignated in the filed Outline of Produc- licensee and one or more subsidiaries, tion for such product in accordance or by two or more subsidiaries. The with § 113.4(b) of this subchapter. exact amount of each serial or sub- (2) For any serial or portion of any serial credited to each participating serial which has left licensed premises: producer shall be determined at the Provided, That product which has been time of labeling and packaging and

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shall be noted in the records for such the records for the serial shall accu- serial or subserial. rately reflect the action taken. [40 FR 46093, Oct. 6, 1975] (d) Test samples of the reprocessed serial and test reports for all tests con- § 114.17 Rebottling of biological prod- ducted shall be submitted to Animal ucts. and Plant Health Inspection Service. The Administrator may authorize The licensee shall not release the serial the rebottling of a completed product until notified by Animal and Plant in liquid form subject to the conditions Health Inspection Service that the se- prescribed in this section. rial is eligible for release. (a) All or part of a serial which has [50 FR 24904, June 15, 1985, as amended at 56 not left the licensed establishment FR 66784, Dec. 26, 1991] may be aseptically returned to the mixing tank, thoroughly mixed, and rebottled in new final containers. PART 115—INSPECTIONS (b) The rebottled product shall be adequately identified by serial number Sec. or subserial number, as the case may 115.1 Inspections of establishments. be. 115.2 Inspections of biological products. (c) Required purity tests for final AUTHORITY: 21 U.S.C. 151–159; 7 CFR 2.22, container samples of the product shall 2.80, and 371.4. be conducted on new samples selected from the rebottled product (serial or § 115.1 Inspections of establishments. subserials). Rebottled product found to (a) Any inspector shall be permitted be unsatisfactory by such tests shall to enter any establishment where any not be released. biological product is prepared, at any (d) New test samples from each serial hour during the day or night, and shall or subserial and copies of test reports be permitted to inspect, without pre- of all tests conducted on the rebottled vious notification, the entire premises product shall be submitted to Animal of the establishment, including all and Plant Health Inspection Service. buildings, compartments, and other (e) The licensee shall not release the places, all biological products, and or- rebottled product unless notified by ganisms and vectors in the establish- Animal and Plant Health Inspection ment, and all materials and equipment, Service that such product is eligible such as chemicals, instruments, appa- for release. Production records shall ratus, and the like, and the methods show the results of all tests conducted used in the manufacture of, and all and shall accurately reflect the actions records maintained relative to, biologi- taken. cal products produced at such estab- [39 FR 16869, May 10, 1974, as amended at 56 lishment. FR 66784, Dec. 26, 1991] (b) Each inspector will have in his or her possession a numbered USDA badge § 114.18 Reprocessing of biological or identification card. Either shall be products. sufficient identification to entitle him/ The Administrator may authorize a her to admittance at all regular en- licensee to reprocess a serial of com- trances and to all parts of such estab- pleted product subject to the condi- lishment and premises and to any place tions prescribed in this section. at any time for the purpose of making (a) Reprocessing shall not include an inspection pursuant to paragraph any method or procedure which would (a) of this section. be deleterious to the product. (b) All appropriate tests for purity, [52 FR 30134, Aug. 13, 1987] safety, potency, and efficacy for the product shall be conducted on the re- § 115.2 Inspections of biological prod- processed product. A serial found un- ucts. satisfactory by a required test shall (a) Any biological product, the con- not be released. tainer of which bears a United States (c) The reprocessed serial shall be veterinary license number or a United identified by a new serial number and States veterinary permit number or

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other mark required by these regula- from compliance with the Virus- tions, may be inspected at any time or Serum-Toxin Act. place. If, as a result of such inspection, (Approved by the Office of Management and it appears that any such product is Budget under control number 0579–0318) worthless, contaminated, dangerous, or harmful, the Secretary shall give no- [72 FR 17798, Apr. 10, 2007] tice to stop distribution and sale to the manufacturer (licensee) or importer PART 116—RECORDS AND REPORTS (permittee) and may proceed against such product pursuant to the provi- Sec. sions of part 118 of this subchapter. 116.1 Applicability and general consider- (b) When notified to stop distribution ations. and sale of a serial or subserial of a 116.2 Inventory and disposition records. veterinary biological product by the 116.3 Label records. Secretary, veterinary biologics licens- 116.4 Sterilization and pasteurization records. ees or permittees shall: 116.5 Reports. (1) Stop the preparation, distribu- 116.6 Animal records. tion, sale, barter, exchange, shipment, 116.7 Test records. or importation of the affected serial(s) 116.8 Completion and retention of records. or subserial(s) of any such veterinary AUTHORITY: 21 U.S.C. 151–159; 7 CFR 2.22, biological product pending further in- 2.80, and 371.4. structions from APHIS. (2) Immediately, but no later than 2 § 116.1 Applicability and general con- days, send stop distribution and sale siderations. notifications to any jobbers, whole- (a) Each licensee, permittee, and for- salers, dealers, foreign consignees, or eign manufacturer of biological prod- other persons known to have any such ucts imported into the United States veterinary biological product in their shall maintain, at the licensed or for- possession, which instruct them to stop eign establishment in which the prod- the preparation, distribution, sale, bar- ucts are prepared, detailed records of ter, exchange, shipment, or importa- information necessary to give a com- tion of any such veterinary biological plete accounting of all the activities product. All notifications shall be doc- within each establishment. Such umented in writing by the licensee or records shall include, but shall not be permittee. limited to, the items enumerated in (3) Account for the remaining quan- this part. tity of each serial(s) or subserial(s) of (1) Records shall be made concur- any such veterinary biological product rently with the performance of succes- at each location in the distribution sive steps in the development and prep- channel known to the manufacturer (li- aration of biological products, includ- censee) or importer (permittee). ing new products under development. (4) When required by the Adminis- Such records shall include the date and trator, submit complete and accurate where critical, the time that each es- reports of all notifications concerning sential step was taken, the identity stop distribution and sale actions to and quantity of ingredients added or the Animal and Plant Health Inspec- removed at each step, and any gain or tion Service pursuant to § 116.5 of this loss of product from the beginning to subchapter. the end of product preparation. (c) Unless and until the Secretary (2) Records shall be legible and indel- shall otherwise direct, no persons so ible; shall be as detailed as necessary notified shall thereafter sell, barter, or for a clear understanding of each step exchange any such product in any by one experienced in the preparation place under the jurisdiction of the of biological products; and shall be United States or ship or deliver for verified by initials or signature of the shipment any such product in or from person immediately responsible for the any State, Territory, or the District of action taken. Columbia. However, failure to receive (3) Records (other than disposition such notice shall not excuse any person records) required by this part shall be

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completed by the licensee or the for- currently being used. Each label shall eign manufacturer, as the case may be, be identified as to: before any portion of a serial of any (1) Name and product code number as product shall be marketed in the it appears on the product license or United States or exported. permit for the product; (b) In the case of imported products, (2) Where applicable, the size of the each permittee shall maintain at the package (doses, ml, cc, or units) on permittee’s place of business detailed which the label shall be used; and accurate records that are relevant (3) Label number and date assigned; to each imported product and that in- and clude, but are not limited to, importa- (4) Name of licensee or subsidiary ap- tion documents, sampling records, test pearing on the label as the producer. summaries, shipping records, and in- (b) All labels printed shall be ac- ventory and disposition records as re- counted for and an inventory main- quired in § 116.2. tained. (c) When authorized by the Adminis- Records shall include the disposition of trator, the licensee, permittee, or for- such labels including those not used in eign manufacturer may maintain and labeling a product. retain records required under this part (Approved by the Office of Management and at an alternative location. Such au- Budget under control number 0579–0013) thorization shall be confirmed by the [39 FR 16872, May 10, 1974, as amended at 48 filing of an addendum to the plot plan FR 57473, Dec. 30, 1983; 61 FR 52874, Oct. 9, legend. The addendum shall list the lo- 1996; 66 FR 21064, Apr. 27, 2001] cation of the records and the condition of their storage and shall permit the § 116.4 Sterilization and pasteurization inspection of the records by APHIS in- records. spectors, or foreign inspectors acting Records shall be made by means of on behalf of APHIS. automatic recording devices or an (Approved by the Office of Management and equivalent accurate and reliable sys- Budget under control number 0579–0013) tem. Such records shall be identified with the ingredients, equipment, or bi- [39 FR 16872, May 10, 1974, as amended at 48 ological product subjected to steriliza- FR 57473, Dec. 30, 1983; 61 FR 52874, Oct. 9, tion or pasteurization. 1996; 66 FR 21064, Apr. 27, 2001] (Approved by the Office of Management and § 116.2 Inventory and disposition Budget under control number 0579–0013) records. [39 FR 16872, May 10, 1974, as amended at 48 (a) Records shall show the quantity FR 57473, Dec. 30, 1983; 61 FR 52874, Oct. 9, and location of each biological product 1996; 66 FR 21064, Apr. 27, 2001] being prepared, in storage, and in distribution channels. § 116.5 Reports. (b) Detailed disposition records, in a (a) When required by the Adminis- form satisfactory to the Adminis- trator, reports containing accurate and trator, shall be maintained by each li- complete information concerning bio- censee, each distributor, and each per- logical products, including but not lim- mittee showing the sale, shipment, or ited to, product development and prep- other disposition made of the biologi- aration, and market suspensions and cal products handled by such person. recalls, shall be prepared and submitted to the Animal and Plant Health (Approved by the Office of Management and Inspection Service by the licensee, per- Budget under control number 0579–0013) mittee, or foreign manufacturer (whose [39 FR 16872, May 10, 1974, as amended at 48 products are being imported or offered FR 57473, Dec. 30, 1983; 56 FR 66784, Dec. 26, for importation). Unless otherwise au- 1991; 61 FR 52874, Oct. 9, 1996; 66 FR 21064, thorized by the Administrator, records Apr. 27, 2001] necessary to make such reports shall be maintained in each establishment. § 116.3 Label records. (b) If, at any time, there are indica- (a) Each licensee and permittee shall tions that raise questions regarding maintain a list of all approved labels the purity, safety, potency, or efficacy

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of a product, or if it appears that there § 116.8 Completion and retention of may be a problem regarding the prepa- records. ration, testing, or distribution of a All records (other than disposition product, the licensee, permittee, or for- records) required by this part shall be eign manufacturer must immediately completed by the licensee, permittee, notify the Animal and Plant Health In- or foreign manufacturer before any spection Service concerning the cir- portion of a serial of any product may cumstances and the action taken, if be marketed in the United States or any. Notification may be made by mail exported. All records shall be retained to Director, Center for Veterinary Bio- at the licensed or foreign establish- logics, Inspection and Compliance, 1920 ment or permittee’s place of business Dayton Avenue, P.O. Box 844, Ames, IA for a period of two years after the expi- 50010; by electronic mail to ration date of a product, or for such ([email protected]); by fax to (515) 337- longer period as may be required by the 6120; or by telephone to (515) 337-6100. Administrator. (Approved by the Office of Management and (Approved by the Office of Management and Budget under control number 0579–0013) Budget under control number 0579–0013) [61 FR 52874, Oct. 9, 1996] [61 FR 52874, Oct. 9, 1996, as amended at 64 FR 43045, Aug. 9, 1999; 75 FR 20773, Apr. 21, 2010] PART 117—ANIMALS AT LICENSED § 116.6 Animal records. ESTABLISHMENTS Complete records shall be kept for all Sec. animals at a licensed establishment. 117.1 Applicability. Results of tests performed, antigens or 117.2 Animal facilities. treatment administered, maintenance 117.3 Admittance of animals. and production records, disposition 117.4 Test animals. records, necropsy records, if any, and 117.5 Segregation of animals. 117.6 Removal of animals. all other pertinent records shall be included. AUTHORITY: 21 U.S.C. 151–159; 7 CFR 2.22, 2.80, and 371.4. (Approved by the Office of Management and SOURCE: 38 FR 15499, June 13, 1973, unless Budget under control number 0579–0013) otherwise noted. [39 FR 16872, May 10, 1974, as amended at 48 FR 57473, Dec. 30, 1983; 61 FR 52874, Oct. 9, § 117.1 Applicability. 1996; 66 FR 21064, Apr. 27, 2001] (a) All animals used in licensed establishments in the preparation or § 116.7 Test records. testing of biological products shall Detailed records of all tests con- meet the regulations in this subchapter ducted on each serial and each sub- and special requirements as may be serial shall be maintained by the li- prescribed by the Administrator to pre- censee. Summaries of such tests shall vent the preparation, sale, and dis- be prepared from such records and sub- tribution of worthless, contaminated, mitted to the Animal and Plant Health dangerous, or harmful biological prod- Inspection Service using APHIS Form ucts. 2008 or an acceptable equivalent form (b) Unless otherwise authorized or di- prior to release of the serial or sub- rected by the Administrator, animals used in the preparation or testing of bi- serial. Blank forms for such summaries ological products shall be admitted to shall be available from Animal and and maintained at the licensed estab- Plant Health Inspection Service upon lishment and ultimately disposed of in request. accordance with the regulations in this (Approved by the Office of Management and part, and with the Act of August 24, Budget under control number 0579–0013) 1966 (Pub. L. 89–544) as amended by the Animal Welfare Act of 1970 (Pub. L. 91– [39 FR 16872, May 10, 1974, as amended at 48 579) and the regulations in parts 1, 2, FR 57473, Dec. 30, 1983; 56 FR 66784, Dec. 26, 1991; 61 FR 52874, Oct. 9, 1996] and 3 of this chapter. Personnel who supervise the care and welfare of such

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animals shall be qualified by edu- eased or dead animals brought into cation, training, and experience to such facilities from being a threat to carry out the regulations in this part. biological products prepared in such es- [38 FR 15499, June 13, 1973, as amended at 56 tablishment or to other animals on the FR 66784, Dec. 26, 1991] premises used in the preparation of biological products. § 117.2 Animal facilities. [38 FR 15499, June 13, 1973, as amended at 56 Animal facilities shall comply with FR 66784, Dec. 26, 1991] the requirements provided in part 108 of this chapter. § 117.4 Test animals. § 117.3 Admittance of animals. (a) All test animals shall be examined for clinical signs of illness, injury, (a) No animal which shows clinical or abnormal behavior prior to the start signs or other evidence of disease shall of a test and throughout the observa- be admitted to the premises of licensed tion period specified in the test pro- establishments, except as provided in tocol. paragraphs (d) and (e) of this section. The health status of all animals offered (b) All animals used for test purposes for admission shall be determined by or shall be identified either collectively under the direction of a veterinarian or individually in a manner conducive prior to admission. If the determina- to an accurate interpretation of the re- tion cannot be made prior to admis- sults of the test. sion, the animals shall be kept sepa- (c) No test animals shall be given a rate from animals already on the prem- biological product during the precondi- ises and in a quarantine area to be pro- tioning period which would affect its vided by the licensee for this purpose eligibility according to the test re- until the animal’s health status is de- quirements. No treatment, with a bio- termined. logical product or otherwise, shall be (b) If special test requirements for administered to a test animal during a admittance of the animals are specified test period which could interfere with a in the Outline of Production for the true evaluation of the biological prod- product to be produced, the animals uct being tested. shall remain in the quarantine area (d) During the course of a test, ani- until such tests have been performed mals that are injured or show clinical and the results obtained. Animals signs of illness or unfavorable reac- which do not meet the requirements tions that are not due to the test may shall not be admitted to the production be removed from the test and treated area or allowed to contact production or humanely destroyed. If sufficient animals. animals do not remain for the test to (c) All animals admitted to the prem- be evaluated, the test shall be declared ises of a licensed establishment shall inconclusive and may be repeated. be permanently identified either col- (e) Test animals that show clinical lectively or individually by the li- signs of illness that are due to the test censee with tags, marks, or other may be treated or humanely destroyed means acceptable to the Adminis- if the illness has progressed to a point trator. (defined in the filed Outline of Produc- (d) When an animal which has a dis- tion) when death is certain to occur ease is to be used to prepare a biologi- without therapeutic intervention. cal product for control of such disease, When interpreting the results of the the animal shall be admitted directly test, the animals that were treated or to the processing facilities in which the humanely destroyed because of illness product is to be prepared but shall not due to the test and the animals that be permitted contact with other ani- have died from illness due to the test mals on the premises. (e) The Administrator may authorize prior to being humanely destroyed the maintenance of diagnostic facili- shall be combined into a common sta- ties at the licensed establishment: Pro- tistic of mortality due to the test. vided, That safeguards proposed by the [38 FR 15499, June 13, 1973, as amended at 60 licensee are adequate to prevent dis- FR 43356, Aug. 21, 1995]

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§ 117.5 Segregation of animals. PART 118—DETENTION; SEIZURE Animals which have been infected AND CONDEMNATION with or exposed to a dangerous, infectious, contagious, or communicable Sec. 118.1 Administrative detention. disease shall be kept effectively seg- 118.2 Method of detention; Notifications. regated at a licensed establishment 118.3 Movement of detained biological prod- until such time as they are humanely ucts; Termination of detention. destroyed or successfully treated and 118.4 Seizure and condemnation. removed as healthy animals. AUTHORITY: 21 U.S.C. 151–159; 7 CFR 2.22, 2.80, and 371.4. § 117.6 Removal of animals. SOURCE: 52 FR 30135, Aug. 13, 1987, unless Production animals or ex-test ani- otherwise noted. mals which are no longer useful at the licensed establishment may be re- § 118.1 Administrative detention. moved from the premises of the li- Whenever any biological product censed establishment; provided, such which is prepared, sold, bartered, ex- removal is accomplished in a manner changed, or shipped in violation of the as shall preclude the dissemination of Act or regulations is found by any au- disease and in accordance with the fol- thorized representative of the Adminis- trator upon any premises, it may be de- lowing conditions: tained by such representative for a pe- (a) Meat-producing animals which re- riod not to exceed 20 days, pending ac- ceived a biological product containing tion under § 118.4, and shall not be inactivated microorganisms and adju- moved by any person from the place at vants within 21 days shall not be re- which it is located when so detained, moved; or until released by such representative. (b) Animals which received virulent [52 FR 30135, Aug. 13, 1987, as amended at 56 microorganisms within 30 days shall FR 66784, Dec. 26, 1991] not be removed; or (c) Only animals that are in a § 118.2 Method of detention; Notifica- healthy condition as determined by a tions. veterinarian shall be removed, except An authorized representative of the as provided in paragraph (d) of this sec- Administrator shall detain any biologi- tion. cal product subject to detention under (d) Other animals that are injured or this part by: otherwise unhealthy, except when af- (a) Giving oral notification to the fected with a communicable disease, owner of the biological product if such may be removed for immediate slaugh- owner can be ascertained, and, if not, ter to an abattoir operated in accord- to the agent representing the owner or ance with the Federal Meat Inspection to the immediate custodian of the biological product; and Act of March 4, 1907, 34 Stat. 1260, as (b) Promptly furnishing the person so amended by the Wholesome Meat Act notified with a preliminary notice of of 1967, 81 Stat. 585 (21 U.S.C. sec. 601 et detention which shall include identity seq.): Provided, That such animals shall and quantity of the product detained, be properly marked for identification the location where detained, the reason and the inspector in charge of slaugh- for the detention, and the name of the ter operations is given due notice in authorized representative of the Ad- advance. ministrator. (e) All animals on the premises shall (c) Within 48 hours after the deten- be disposed of in accordance with the tion of any biological product, an au- provisions of the regulations in this thorized representative of the Adminis- part and where specific provision is not trator shall, if the detention is to con- made therefor shall be disposed of as tinue, give written notification to the required by the Administrator. owner of the biological product detained by furnishing a written state- [38 FR 15499, June 13, 1973, as amended at 56 ment which shall include the identity FR 66784, Dec. 26, 1991] and quantity of the product detained,

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the location where detained, specific addressed to such person at the last description of the alleged noncompli- known residence or principal office or ance including reference to the provi- place of business of the owner, agent, sions in the Act or the regulations or other person having custody of the which have resulted in the detention, biological product. and the identity of the authorized representative of the Administrator; or, if [52 FR 30135, Aug. 13, 1987, as amended at 56 such owner cannot be ascertained and FR 66784, Dec. 26, 1991] notified within such period of time, § 118.4 Seizure and condemnation. furnish such notice to the agent representing such owner, or the carrier or Any biological product which is pre- other person having custody of the bio- pared, sold, bartered, exchanged, or logical product detained. The notifica- shipped in violation of the Act or regu- tion, with a copy of the preliminary lations shall be liable to be proceeded notice of detention shall be served by against and seized and condemned, at either delivering the notification to any time, on a libel of information in the owner or to the agent or to such any United States district court or other person, or by certifying and mail- other proper court within the jurisdic- ing the notification, addressed to such tion of which the product is found. If owner, agent, or other person, at the the product is condemned, it shall, last known residence or principal office after entry of the decree, be disposed of or place of business. by destruction or sale as the court may [52 FR 30135, Aug. 13, 1987, as amended at 56 direct, and the proceeds, if sold, less FR 66784, Dec. 26, 1991] the court costs and fees, and storage and other proper expenses, shall be § 118.3 Movement of detained biologi- paid into the Treasury of the United cal products; Termination of deten- States, but the product shall not be tion. sold contrary to the provisions of the Except as provided in paragraphs (a) Act or the laws of the jurisdiction in and (b) of this section, no biological which it is sold; Provided, That, upon product detained in accordance with the execution and delivery of a good the provisions in this part shall be and sufficient bond conditioned that moved by any person from the place at the product shall not be sold or other- which such product is located when it wise disposed of contrary to the provi- is detained. sions of the Act or the laws or jurisdic- (a) A detained biological product tion in which disposal is made, the may be moved from the place at which court may direct that such product be it is located when so detained for the delivered to the owner thereof subject purpose of providing proper storage to such supervision by authorized rep- conditions if such movement has been resentatives of the Administrator as is approved by an authorized representa- necessary to ensure compliance with tive of the Administrator; Provided, the applicable laws. When a decree of That, the biological product so moved condemnation is entered against the shall be detained by an authorized rep- product and it is released under bond, resentative of the Administrator after or destroyed, court costs and fees, and such movement. storage and other proper expenses shall (b) A detained biological product be awarded against the person, if any, may be moved from the place at which intervening as claimant of the product. it is detained on written notification The proceedings in such libel cases by an authorized representative of the shall conform, as nearly as may be Administrator that the detention is practicable, to the proceedings in ad- terminated; Provided, That, the condi- miralty, except that either party may tions under which the detained biologi- demand trial by jury of any issue of cal product may be moved will be spec- fact joined in any case, and all such ified in the written notification of the termination. The notification of termi- proceedings shall be at the suit of and nation shall be served by either person- in the name of the United States. ally delivering the notification, or by [52 FR 30135, Aug. 13, 1987, as amended at 56 certifying and mailing the notification FR 66784, Dec. 26, 1991]

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PART 121—POSSESSION, USE, AND (2) Deterioration of food, water, TRANSFER OF SELECT AGENTS equipment, supplies, or material of any AND TOXINS kind; or (3) Deleterious alteration of the environment. Sec. 121.1 Definitions. Centers for Disease Control and Preven- 121.2 Purpose and scope. tion (CDC). The Centers for Disease 121.3 VS select agents and toxins. Control and Prevention of the U.S. De- 121.4 Overlap select agents and toxins. partment of Health and Human Serv- 121.5 Exemptions for VS select agents and ices. toxins. Diagnosis. The analysis of specimens 121.6 Exemptions for overlap select agents for the purpose of identifying or con- and toxins. firming the presence or characteristics 121.7 Registration and related security risk of a select agent or toxin, provided assessments. that such analysis is directly related to 121.8 Denial, revocation, or suspension of protecting the public health or safety, registration. animal health or animal products, or 121.9 Responsible official. 121.10 Restricting access to select agents plant health or plant products. and toxins; security risk assessments. Entity. Any government agency (Fed- 121.11 Security. eral, State, or local), academic institu- 121.12 Biosafety. tion, corporation, company, partner- 121.13 Restricted experiments. ship, society, association, firm, sole 121.14 Incident response. proprietorship, or other legal entity. 121.15 Training. HHS Secretary. The Secretary of the 121.16 Transfers. Department of Health and Human 121.17 Records. Services or his or her designee, unless 121.18 Inspections. otherwise specified. 121.19 Notification of theft, loss, or release. HHS select agent and/or toxin. A bio- 121.20 Administrative review. logical agent or toxin listed in 42 CFR AUTHORITY: 7 U.S.C. 8401; 7 CFR 2.22, 2.80, 73.3. and 371.4. Import. To move into, or the act of SOURCE: 70 FR 13284, Mar. 18, 2005, unless movement into, the territorial limits otherwise noted. of the United States. Information security. Protecting infor- § 121.1 Definitions. mation and information systems from Administrator. The Administrator, unauthorized access, use, disclosure, Animal and Plant Health Inspection disruption, modification, or destruc- Service, or any person authorized to tion in order to provide: act for the Administrator. (1) Integrity, which means guarding Animal and Plant Health Inspection against improper information modi- Service (APHIS). The Animal and Plant fication or destruction, and includes Health Inspection Service of the U.S. ensuring information authenticity; Department of Agriculture. (2) Confidentiality, which means pre- Attorney General. The Attorney Gen- serving authorized restrictions on ac- eral of the United States or any person cess and disclosure, including means authorized to act for the Attorney Gen- for protecting personal privacy and eral. proprietary information; and Biological agent. Any microorganism (3) Availability, which means ensuring (including, but not limited to, bacteria, timely and reliable access to and use of viruses, fungi, or protozoa), or infec- information. tious substance, or any naturally oc- Interstate. From one State into or curring, bioengineered, or synthesized through any other State, or within the component of any such microorganism District of Columbia, Guam, the Virgin or infectious substance, capable of Islands of the United States, or any causing: other territory or possession of the (1) Death, disease, or other biological United States. malfunction in a human, an animal, a Occupational exposure. Any reason- plant, or another living organism; ably anticipated skin, eye, mucous

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membrane, parenteral contact, or res- Toxin. The toxic material or product piratory aerosol exposure to select of plants, animals, microorganisms (in- agents or toxins that may result from cluding, but not limited to, bacteria, the performance of an employee’s du- viruses, fungi, or protozoa), or infec- ties. tious substances, or a recombinant or Overlap select agent and/or toxin. A bi- synthesized molecule, whatever their ological agent or toxin that is listed in origin and method of production, and § 121.4 and 42 CFR 73.4. includes: Permit. A written authorization by (1) Any poisonous substance or bio- the Administrator to import or move logical product that may be engineered interstate select agents or toxins, as a result of biotechnology produced under conditions prescribed by the Ad- by a living organism; or ministrator. (2) Any poisonous isomer or biologi- Proficiency testing. The process of de- cal product, homolog, or derivative of termining the competency of an indi- such a substance. vidual or laboratory to perform a speci- United States. All of the States. fied test or procedure. USDA. The U.S. Department of Agri- Recombinant nucleic acids. (1) Mol- culture. ecules that are constructed by joining Verification. The demonstration of ob- nucleic acid molecules and that can taining established performance (e.g., replicate in a living cell; or accuracy, precision, and the analytical (2) Molecules that result from the sensitivity and specificity) specifica- replication of those described in para- tions for any procedure used for diag- graph (1) of this definition. nosis. Responsible official. The individual VS. The Veterinary Services Pro- designated by an entity with the au- grams of the Animal and Plant Health thority and control to ensure compli- Inspection Service. ance with the regulations in this part. VS select agent and/or toxin. A biologi- Security barrier. A physical structure cal agent or toxin listed in § 121.3. that is designed to prevent entry by [70 FR 13284, Mar. 18, 2005, as amended at 77 unauthorized persons. FR 61077, Oct. 5, 2012] Select agent and/or toxin. Unless otherwise specified, all of the biological § 121.2 Purpose and scope. agents or toxins listed in §§ 121.3 and This part implements the provisions 121.4. of the Agricultural Bioterrorism Pro- Specimen. Samples of material from tection Act of 2002 setting forth the re- humans, animals, plants, or the envi- quirements for possession, use, and ronment, or isolates or cultures from transfer of select agents and toxins. such samples, for diagnosis, The biological agents and toxins listed verification, or proficiency testing. in this part have the potential to pose State. Any of the several States of the a severe threat to public health and United States, the Commonwealth of safety, to animal health, or to animal the Northern Mariana Islands, the products. Overlap select agents and Commonwealth of Puerto Rico, the toxins are subject to regulation by District of Columbia, Guam, the Virgin both APHIS and CDC. Islands of the United States, or any other territory or possession of the § 121.3 VS select agents and toxins. United States. (a) Except as provided in paragraphs Synthetic nucleic acids. (1) Molecules (d) and (e) of this section, the Adminis- that are chemically or by other means trator has determined that the biologi- synthesized or amplified, including cal agents and toxins listed in this sec- those that are chemically or otherwise tion have the potential to pose a severe modified but can base pair with natu- threat to animal health or to animal rally occurring nucleic acid molecules products. The select agents and toxins (i.e., synthetic nucleic acids); or marked with an asterisk (*) are des- (2) Molecules that result from the ignated as Tier 1 select agents and tox- replication of those described in para- ins and are subject to additional re- graph (1) of this definition. quirements as listed in this part.

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(b) VS select agents and toxins: Afri- (3) Any low pathogenic strains of can horse sickness virus; African swine avian influenza virus, any strain of fever virus; Avian influenza virus; Clas- Newcastle disease virus which does not sical swine fever virus; *Foot-and- meet the criteria for virulent New- mouth disease virus; Goat pox virus; castle disease virus, all subspecies Lumpy skin disease virus; Mycoplasma Mycoplasma capricolum except sub- capricolum; Mycoplasma mycoides; New- species capripneumoniae (contagious castle disease virus; 1 Peste des petits caprine pleuropneumonia), and all sub- ruminants virus; *Rinderpest virus; species Mycoplasma mycoides except Sheep pox virus; Swine vesicular dis- subspecies mycoides small colony (Mmm ease virus. SC) (contagious bovine (c) Genetic elements, recombinant pleuropneumonia), provided that the and/or synthetic nucleic acids, and re- individual or entity can verify that the combinant and/or synthetic organisms: agent is within the exclusion category. (1) Nucleic acids that can produce in- (e) An attenuated strain of a select fectious forms of any of the select agent or an inactive form of a select agent viruses listed in paragraph (b) of toxin may be excluded from the re- this section. 2 quirements of this part based upon a (2) Recombinant and/or synthetic nu- determination by the Administrator cleic acids that encode for the func- that the attenuated strain or inac- tional forms of any toxin listed in tivated toxin does not pose a severe paragraph (b) of this section if the nu- threat to animal health or to animal cleic acids: products. (i) Can be expressed in vivo or in vitro; (1) To apply for exclusion, an indi- or vidual or entity must submit a written (ii) Are in a vector or recombinant request and supporting scientific infor- host genome and can be expressed in mation. A written decision granting or vivo or in vitro. denying the request will be issued. An (3) VS select agents and toxins listed exclusion will be effective upon notifi- in paragraph (b) of this section that cation to the applicant. Exclusions will have been genetically modified. be listed on the National Select Agent (d) VS select agents or toxins that Registry Web site at http:// meet any of the following criteria are www.selectagents.gov/. excluded from the requirements of this (2) If an excluded attenuated strain part: or inactivated toxin is subjected to any (1) Any VS select agent or toxin that manipulation that restores or enhances is in its naturally occurring environ- its virulence or toxic activity, the re- ment, provided that the agent or toxin sulting select agent or toxin will be has not been intentionally introduced, subject to the requirements of this cultivated, collected, or otherwise ex- part. tracted from its natural source. (f) Any VS select agent or toxin (2) Nonviable VS select agents or seized by a Federal law enforcement 3 nonfunctional VS toxins. agency will be excluded from the requirements of this part during the pe- 1 A virulent Newcastle disease virus (avian riod between seizure of the agent or paramyxovirus serotype 1) has an toxin and the transfer or destruction of intracerebral pathogenicity index in day-old such agent or toxin provided that: chicks (Gallus gallus) of 0.7 or greater or has an amino acid sequence at the fusion (F) pro- (1) As soon as practicable, the Fed- tein cleavage site that is consistent with vir- eral law enforcement agency transfers ulent strains of Newcastle disease virus. A the seized agent or toxin to an entity failure to detect a cleavage site that is con- eligible to receive such agent or toxin sistent with virulent strains does not con- or destroys the agent or toxin by a rec- firm the absence of a virulent virus. ognized sterilization or inactivation 2 The importation and interstate move- process. ment of VS select agents or toxins listed in (2) The Federal law enforcement paragraphs (c)(1) through (c)(3) of this section may be subject to the permit require- agency safeguards and secures the ments under part 122 of this subchapter. 3 However, the importation and interstate may be subject to the permit requirements movement of these nonviable select agents under part 122 of this subchapter.

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seized agent or toxin against theft, (c) Genetic elements, recombinant loss, or release, and reports any theft, and/or synthetic nucleic acids, and re- loss, or release of such agent or toxin. combinant and/or synthetic organisms: (3) The Federal law enforcement (1) Nucleic acids that can produce in- agency reports the seizure of the select fectious forms of any of the overlap se- agent or toxin to APHIS or CDC. lect agent viruses listed in paragraph (i) The seizure of any of the following (b) of this section. 4 VS select agents and toxins must be re- (2) Recombinant and/or synthetic nu- ported within 24 hours by telephone, cleic acids that encode for the func- facsimile, or e-mail: African horse tional forms of any overlap toxin listed sickness virus, African swine fever in paragraph (b) of this section if the virus, avian influenza virus (highly nucleic acids: pathogenic), bovine spongiform (i) Can be expressed in vivo or in vitro; encephalopathy agent, classical swine or fever virus, foot-and-mouth disease (ii) Are in a vector or recombinant virus, virulent Newcastle disease virus, host genome and can be expressed in rinderpest virus, and swine vesicular vivo or in vitro. disease virus. This report must be fol- (3) Overlap select agents and toxins lowed by submission of APHIS/CDC listed in paragraph (b) of this section Form 4 within 7 calendar days after that have been genetically modified. seizure of the select agent or toxin. (d) Overlap select agents or toxins (ii) For all other VS select agents or that meet any of the following criteria toxins, APHIS/CDC Form 4 must be are excluded from the requirements of submitted within 7 calendar days after this part: seizure of the agent or toxin. (1) Any overlap select agent or toxin (iii) A copy of APHIS/CDC Form 4 that is in its naturally occurring envi- must be maintained for 3 years. ronment, provided that the agent or (4) The Federal law enforcement toxin has not been intentionally intro- agency reports the final disposition of duced, cultivated, collected, or other- the select agent or toxin by submission wise extracted from its natural source. of APHIS/CDC Form 4. A copy of the (2) Nonviable overlap select agents or completed form must be maintained nonfunctional overlap toxins. 5 for 3 years. (3) Any subtypes of Venezuelan [70 FR 13284, Mar. 18, 2005, as amended at 73 equine encephalitis virus except for FR 61331, Oct. 16, 2008; 77 FR 61077, Oct. 5, Subtypes IAB or IC, provided that the 2012] individual or entity can verify that the § 121.4 Overlap select agents and tox- agent is within the exclusion category. ins. (e) An attenuated strain of a select agent or an inactive form of a select (a) Except as provided in paragraphs toxin may be excluded from the re- (d) and (e) of this section, the Adminis- quirements of this part based upon a trator has determined that the biologi- determination by the HHS Secretary or cal agents and toxins listed in this sec- Administrator that the attenuated tion have the potential to pose a severe strain or inactivated toxin does not threat to public health and safety, to pose a severe threat to public health animal health, or to animal products. and safety, to animal health or to ani- The select agents and toxins marked mal products. with an asterisk (*) are designated as (1) To apply for exclusion, an indi- Tier 1 select agents and toxins and are vidual or entity must submit a written subject to additional requirements as listed in this part. (b) Overlap select agents and toxins: 4 The importation and interstate move- *Bacillus anthracis; Bacillus anthracis ment of overlap select agents or toxins listed (Pasteur strain); Brucella abortus; in paragraphs (c)(1) through (c)(3) of this sec- Brucella melitensis; Brucella suis; tion may be subject to the permit requirements under part 122 of this subchapter. *Burkholderia mallei; *Burkholderia 5 However, the importation and interstate pseudomallei; Hendra virus; Nipah virus; movement of these nonviable overlap select Rift Valley fever virus; Venezuelan agents may be subject to the permit require- equine encephalitis virus. ments under part 122 of this subchapter.

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request and supporting scientific infor- copy of the completed form must be mation. A written decision granting or maintained for 3 years. denying the request will be issued. An [70 FR 13284, Mar. 18, 2005, as amended at 73 exclusion will be effective upon notifi- FR 61331, Oct. 16, 2008; 77 FR 61078, Oct. 5, cation to the applicant. Exclusions will 2012] be listed on the National Select Agent Registry Web site at http:// § 121.5 Exemptions for VS select www.selectagents.gov/. agents and toxins. (2) If an excluded attenuated strain (a) Diagnostic laboratories and other or inactivated toxin is subjected to any entities that possess, use, or transfer a manipulation that restores or enhances VS select agent or toxin that is con- its virulence or toxic activity, the retained in a specimen presented for di- sulting select agent or toxin will be agnosis or verification will be exempt subject to the requirements of this from the requirements of this part for part. such agent or toxin contained in the (f) Any overlap select agent or toxin specimen, provided that: seized by a Federal law enforcement (1) Unless directed otherwise by the agency will be excluded from the re- Administrator, within 7 calendar days quirements of this part during the pe- after identification, the agent or toxin riod between seizure of the agent or is transferred in accordance with toxin and the transfer or destruction of § 121.16 or destroyed on-site by a recog- such agent or toxin provided that: nized sterilization or inactivation proc- (1) As soon as practicable, the Fed- ess; eral law enforcement agency transfers (2) The agent or toxin is secured the seized agent or toxin to an entity against theft, loss, or release during eligible to receive such agent or toxin the period between identification of or destroys the agent or toxin by a rec- the agent or toxin and transfer or de- ognized sterilization or inactivation struction of such agent or toxin, and process. any theft, loss, or release of such agent (2) The Federal law enforcement or toxin is reported; and agency safeguards and secures the (3) The identification of the agent or seized agent or toxin against theft, toxin is reported to APHIS or CDC. loss, or release, and reports any theft, (i) The identification of any of the loss, or release of such agent or toxin. following select agents and toxins must (3) The Federal law enforcement be immediately reported by telephone, agency reports the seizure of the over- facsimile, or e-mail: African horse lap select agent or toxin to APHIS or sickness virus, African swine fever CDC. virus, avian influenza virus (highly (i) The seizure of any of the following pathogenic), classical swine fever overlap select agents and toxins must virus, foot-and-mouth disease virus, be reported within 24 hours by tele- virulent Newcastle disease virus, rin- phone, facsimile, or e-mail: Bacillus derpest virus, and swine vesicular dis- anthracis, Burkholderia mallei, and ease virus. This report must be fol- Burkholderia pseudomallei. This report lowed by submission of APHIS/CDC must be followed by submission of Form 4 within 7 calendar days after APHIS/CDC Form 4 within 7 calendar identification. days after seizure of the overlap select (ii) For all other VS select agents or agent or toxin. toxins, APHIS/CDC Form 4 must be (ii) For all other overlap select submitted within 7 calendar days after agents or toxins, APHIS/CDC Form 4 identification. must be submitted within 7 calendar (iii) Less stringent reporting may be days after seizure of the agent or toxin. required during agricultural emer- (iii) A copy of APHIS/CDC Form 4 gencies or outbreaks, or in endemic must be maintained for 3 years. areas. (4) The Federal law enforcement (iv) A copy of APHIS/CDC Form 4 agency reports the final disposition of must be maintained for 3 years. the overlap select agent or toxin by (b) Diagnostic laboratories and other submission of APHIS/CDC Form 4. A entities that possess, use, or transfer a

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VS select agent or toxin that is con- not necessary to protect animal health tained in a specimen presented for pro- or animal products. To apply for an ex- ficiency testing will be exempt from emption, an individual or entity must the requirements of this part for such submit APHIS/CDC Form 5. A written agent or toxin contained in the speci- decision granting or denying the ex- men, provided that: emption will be issued. The applicant (1) Unless directed otherwise by the must notify APHIS when an authoriza- Administrator, within 90 calendar days tion for an investigation no longer ex- of receipt, the agent or toxin is trans- ists. This exemption automatically ter- ferred in accordance with § 121.16 or de- minates when such authorization is no stroyed on-site by a recognized steri- longer in effect. lization or inactivation process; (f) In addition to the exemptions pro- (2) The agent or toxin is secured vided in paragraphs (a) through (e) of against theft, loss, or release during this section, the Administrator may the period between identification of grant a specific exemption upon a the agent or toxin and transfer or de- showing of good cause and upon his or struction of such agent or toxin, and her determination that such exemption any theft, loss, or release of such agent is consistent with protecting animal or toxin is reported; and health or animal products. An indi- (3) The identification of the agent or vidual or entity may request in writing toxin, and its derivative, is reported to an exemption from the requirements of APHIS or CDC. To report the identi- this part. If granted, such exemptions fication of a select agent or toxin, are valid for a maximum of 3 years; APHIS/CDC Form 4 must be submitted thereafter, an individual or entity within 90 days of receipt of the agent must request a new exemption. If a re- or toxin. A copy of the completed form quest for exemption is denied, an indi- must be maintained for 3 years. vidual or entity may request reconsid- (c) Diagnostic reagents and vaccines eration in writing to the Adminis- that are, bear, or contain VS select trator. The request for reconsideration agents or toxins that are produced at must state all of the facts and reasons USDA diagnostic facilities will be ex- upon which the individual or entity re- empt from the requirements of this lies to show that the exemption was part. wrongfully denied. The Administrator (d) Unless the Administrator by order will grant or deny the request for re- determines that additional regulation consideration as promptly as cir- is necessary to protect animal health cumstances allow and will state, in or animal products, products that are, writing, the reasons for the decision. bear, or contain VS select agents or [70 FR 13284, Mar. 18, 2005, as amended at 73 toxins will be exempt from the require- FR 61331, Oct. 16, 2008; 77 FR 61078, Oct. 5, ments of this part if the products have 2012] been cleared, approved, licensed, or registered pursuant to: § 121.6 Exemptions for overlap select (1) The Federal Food, Drug, and Cos- agents and toxins. metic Act (21 U.S.C. 301 et seq.); (a) Clinical or diagnostic laboratories (2) Section 351 of Public Health Serv- and other entities that possess, use, or ice Act (42 U.S.C. 262); transfer an overlap select agent or (3) The Virus-Serum-Toxin Act (21 toxin that is contained in a specimen U.S.C. 151–159); or presented for diagnosis or verification (4) The Federal Insecticide, Fun- will be exempt from the requirements gicide, and Rodenticide Act (7 U.S.C. of this part for such agent or toxin con- 131 et seq.). tained in the specimen, provided that: (e) The Administrator may exempt (1) Unless directed otherwise by the from the requirements of this part an Administrator or the HHS Secretary, experimental product that is, bears, or within 7 calendar days after identifica- contains a VS select agent or toxin if tion, the agent or toxin is transferred such product is being used in an inves- in accordance with § 121.16 or 42 CFR tigation authorized by any Federal law 73.16 or destroyed on-site by a recog- and the Administrator determines that nized sterilization or inactivation proc- additional regulation under this part is ess;

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(2) The agent or toxin is secured (c) Unless the Administrator by order against theft, loss, or release during determines that additional regulation the period between identification of of a specific product is necessary to the agent or toxin and transfer or de- protect animal health or animal prod- struction of such agent or toxin, and ucts, products that are, bear, or con- any theft, loss, or release of such agent tain overlap select agents or toxins or toxin is reported; and will be exempt from the requirements (3) The identification of the agent or of this part if the products have been toxin is reported to APHIS or CDC. cleared, approved, licensed, or reg- (i) The identification of any of the istered pursuant to: following overlap select agents and (1) The Federal Food, Drug, and Cos- toxins must be immediately reported metic Act (21 U.S.C. 301 et seq.); by telephone, facsimile, or e-mail: Ba- (2) Section 351 of Public Health Serv- cillus anthracis, Burkholderia mallei, and ice Act (42 U.S.C. 262); Burkholderia pseudomallei. This report (3) The Virus-Serum-Toxin Act (21 must be followed by submission of U.S.C. 151–159); or APHIS/CDC Form 4 within 7 calendar (4) The Federal Insecticide, Fun- days after identification. gicide, and Rodenticide Act (7 U.S.C. (ii) For all other overlap select 131 et seq.). agents or toxins, APHIS/CDC Form 4 (d) After consultation with the HHS must be submitted within 7 calendar Secretary, the Administrator may ex- days after identification. empt from the requirements of this (iii) Less stringent reporting may be part an investigational product that is, required during agricultural emer- bears, or contains an overlap select gencies or outbreaks, or in endemic agent or toxin if such product is being areas. used in an investigation authorized by (iv) A copy of APHIS/CDC Form 4 any Federal law and the Administrator must be maintained for 3 years. determines that additional regulation (b) Clinical or diagnostic laboratories under this part is not necessary to pro- and other entities that possess, use, or tect animal health or animal products. transfer an overlap select agent or (1) To apply for an exemption, an in- toxin that is contained in a specimen dividual or entity must submit APHIS/ presented for proficiency testing will CDC Form 5. be exempt from the requirements of (2) The Administrator will make a this part for such agent or toxin con- determination regarding an exemption tained in the specimen, provided that: within 14 calendar days after receipt of (1) Unless directed otherwise by the the application and notification that Administrator or the HHS Secretary, the investigation has been authorized within 90 days of receipt, the agent or under a Federal law. A written decision toxin is transferred in accordance with granting or denying the exemption will § 121.16 or 42 CFR 73.16 or destroyed on- be issued. site by a recognized sterilization or in- (3) The applicant must notify APHIS activation process; or CDC when an authorization for an (2) The agent or toxin is secured investigation no longer exists. This ex- against theft, loss, or release during emption automatically terminates the period between identification of when such authorization is no longer in the agent or toxin and transfer or de- effect. struction of such agent or toxin, and (e) The Administrator may exempt any theft, loss, or release of such agent an individual or entity from the re- or toxin is reported; and quirements of this part for 30 calendar (3) The identification of the agent or days if it is necessary to respond to a toxin, and its derivative, is reported to domestic or foreign agricultural emer- APHIS or CDC. To report the identi- gency involving an overlap select agent fication of an overlap select agent or or toxin. The Administrator may ex- toxin, APHIS/CDC Form 4 must be sub- tend the exemption once for an addi- mitted within 90 calendar days of re- tional 30 days. ceipt of the agent or toxin. A copy of (f) Upon request of the Secretary of the completed form must be main- Health and Human Services, the Ad- tained for 3 years. ministrator may exempt an individual

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or entity from the requirements of this vidual is in a managerial or executive part for 30 calendar days if the Sec- capacity with regard to the entity’s se- retary of Health and Human Services lect agents or toxins or with regard to has granted an exemption for a public the individuals with access to the se- health emergency involving an overlap lect agents or toxins possessed, used, or select agent or toxin. The Adminis- transferred by the entity. trator may extend the exemption once (ii) For entities other than institu- for an additional 30 days. tions of higher education, an individual [70 FR 13284, Mar. 18, 2005, as amended at 73 will be deemed to own or control the FR 61331, Oct. 16, 2008; 77 FR 61078, Oct. 5, entity if the individual: 2012] (A) Owns 50 percent or more of the entity, or is a holder or owner of 50 per- § 121.7 Registration and related secu- cent or more of its voting stock; or rity risk assessments. (B) Is in a managerial or executive (a) Unless exempted under § 121.5, an capacity with regard to the entity’s se- individual or entity shall not possess, lect agents or toxins or with regard to use, or transfer any VS select agent or the individuals with access to the se- toxin without a certificate of registra- lect agents or toxins possessed, used, or tion issued by the Administrator. Un- transferred by the entity. less exempted under § 121.6 or 42 CFR (4) An entity will be considered to be 73.6, an individual or entity shall not an institution of higher education if it possess, use, or transfer any overlap se- is an institution of higher education as lect agent or toxin without a certifi- defined in section 101(a) of the Higher cate of registration issued by the Ad- Education Act of 1965 (20 U.S.C. ministrator and the HHS Secretary. 1001(a)), or is an organization described (b) As a condition of registration, in 501(c)(3) of the Internal Revenue each entity must designate an indi- Code of 1986, as amended (26 U.S.C. vidual to be its responsible official. 501(c)(3)). While most registrants are likely to be entities, in the event that an indi- (5) To obtain a security risk assess- vidual applies for and is granted a cer- ment, an individual or entity must sub- tificate of registration, the individual mit the information necessary to con- will be considered the responsible offi- duct a security risk assessment to the cial. Attorney General. (c)(1) As a condition of registration, (d) To apply for a certificate of reg- the following must be approved by the istration for only VS select agents or Administrator or the HHS Secretary toxins, or for VS and PPQ select agents based on a security risk assessment by or toxins, an individual or entity must the Attorney General: submit the information requested in (i) The individual or entity; the registration application package (ii) The responsible official; and (APHIS/CDC Form 1) to APHIS. To (iii) Unless otherwise exempted under apply for a certificate of registration this section, any individual who owns for overlap select agents or toxins, or controls the entity. overlap select agents or toxins and any (2) Federal, State, or local govern- combination of PPQ or VS select mental agencies, including public ac- agents or toxins, or HHS select agents credited academic institutions, are ex- or toxins and any combination of PPQ empt from the security risk assess- or VS select agents or toxins, an indi- ments for the entity and the individual vidual or entity must submit the infor- who owns or controls such entity. mation requested in the registration (3) An individual will be deemed to application package (APHIS/CDC Form own or control an entity under the fol- 1) to APHIS or CDC, but not both. lowing conditions: 6 (e) Prior to the issuance of a certifi- (i) For a private institution of higher cate of registration, the responsible of- education, an individual will be deemed ficial must promptly provide notifica- to own or control the entity if the indi- tion of any changes to the application for registration by submitting the rel- 6 These conditions may apply to more than evant page(s) of the registration appli- one individual. cation.

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(f) The issuance of a certificate of the Attorney General and who meets registration may be contingent upon the requirements of this part. inspection or submission of additional (j) A certificate of registration will information, such as the security plan, be terminated upon the written request biosafety plan, incident response plan, of the entity if the entity no longer or any other documents required to be possesses or uses any select agents or prepared under this part. toxins and no longer wishes to be reg- (g) A certificate of registration will istered. be valid for one physical location (a (k) A certificate of registration will room, a building, or a group of build- be valid for a maximum of 3 years. ings) where the responsible official will [70 FR 13284, Mar. 18, 2005, as amended at 73 be able to perform the responsibilities FR 61331, Oct. 16, 2008] required in this part, for specific select agents or toxins, and for specific ac- § 121.8 Denial, revocation, or suspen- tivities. sion of registration. (h) A certificate of registration may (a) An application may be denied or a be amended to reflect changes in cir- certificate of registration revoked or cumstances (e.g., replacement of the suspended if: responsible official or other personnel (1) The individual or entity, the re- changes, changes in ownership or con- sponsible official, or an individual who trol of the entity, changes in the ac- owns or controls the entity is within tivities involving any select agents or any of the categories described in 18 toxins, or the addition or removal of U.S.C. 175b; select agents or toxins). (2) The individual or entity, the re- (1) Prior to any change, the respon- sponsible official, or an individual who sible official must apply for an amend- owns or controls the entity is reason- ment to a certificate of registration by ably suspected by any Federal law en- submitting the relevant page(s) of the forcement or intelligence agency of: registration application. 7 (i) Committing a crime set forth in 18 (2) The responsible official will be no- U.S.C. 2332b(g)(5); or tified in writing if an application to (ii) Knowing involvement with an or- amend a certificate of registration has ganization that engages in domestic or been approved. Approval of an amend- international terrorism (as defined in ment may be contingent upon an in- 18 U.S.C. 2331) or with any other orga- spection or submission of additional in- nization that engages in intentional formation, such as the security plan, crimes of violence; or biosafety plan, incident response plan, (iii) Being an agent of a foreign or any other documents required to be power as defined in 50 U.S.C. 1801; prepared under this part. (3) The individual or entity does not (3) No change may be made without meet the requirements of this part; 8 or such approval. (4) It is determined that such action (i) An entity must immediately no- is necessary to protect animal health tify APHIS or CDC if it loses the serv- or animal products. ices of its responsible official. In the (b) Upon revocation or suspension of event that an entity loses the services a certificate of registration, the indi- of its responsible official, an entity vidual or entity must: may continue to possess or use select (1) Immediately stop all use of each agents or toxins only if it appoints as select agent or toxin covered by the the responsible official another indi- revocation or suspension order; vidual who has been approved by the (2) Immediately safeguard and secure Administrator or the HHS Secretary each select agent or toxin covered by following a security risk assessment by the revocation or suspension order from theft, loss, or release; and (3) Comply with all disposition in- 7 Depending on the change, a security risk assessment by the Attorney General may structions issued by the Administrator also be required (e.g., replacement of the responsible official, changes in ownership or 8 If registration is denied for this reason, control of the entity, new researchers or we may provide technical assistance and graduate students, etc.) guidance.

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for each select agent or toxin covered contained in a specimen presented for by the revocation or suspension. diagnosis or verification. (c) Denial of an application for reg- (1) The identification of any of the istration and revocation of registration following select agents or toxins must may be appealed under § 121.20. How- be immediately reported by telephone, ever, any denial of an application for facsimile, or email: African horse sick- registration or revocation of a certifi- ness virus, African swine fever virus, cate of registration will remain in ef- avian influenza virus (highly patho- fect until a final agency decision has genic), Bacillus anthracis, Burkholderia been rendered. mallei, Burkholderia pseudomallei, classical swine fever virus, foot-and-mouth [70 FR 13284, Mar. 18, 2005, as amended at 73 disease virus, virulent Newcastle dis- FR 61331, Oct. 16, 2008] ease virus, rinderpest virus, and swine § 121.9 Responsible official. vesicular disease virus. The final disposition of the agent or toxin must be (a) An individual or entity required reported by submission of APHIS/CDC to register under this part must des- Form 4 within 7 calendar days after ignate an individual to be the respon- identification. A copy of the completed sible official. The responsible official form must be maintained for 3 years. must: (2) To report the identification and (1) Be approved by the Administrator final disposition of any other select or the HHS Secretary following a secu- agent or toxin, APHIS/CDC Form 4 rity risk assessment by the Attorney must be submitted within 7 calendar General; days after identification. A copy of the (2) Be familiar with the requirements completed form must be maintained of this part; for 3 years. (3) Have authority and responsibility (3) Less stringent reporting may be to act on behalf of the entity; required during agricultural emer- (4) Ensure compliance with the re- gencies or outbreaks, or in endemic quirements of this part; areas. (5) Have a physical (and not merely a (d) The responsible official must re- telephonic or audio/visual) presence at port the identification and final dis- the registered entity to ensure that the position of any select agent or toxin entity is in compliance with the select contained in a specimen presented for agent regulations and be able to re- proficiency testing. To report the iden- spond in a timely manner to onsite in- tification and final disposition of a se- cidents involving select agents and tox- lect agent or toxin, APHIS/CDC Form 4 ins in accordance with the entity’s in- must be submitted within 90 calendar cident response plan; and days of receipt of the agent or toxin. A (6) Ensure that annual inspections copy of the completed form must be are conducted for each laboratory maintained for 3 years. where select agents or toxins are [70 FR 13284, Mar. 18, 2005, as amended at 73 stored or used in order to determine FR 61332, Oct. 16, 2008; 77 FR 61078, Oct. 5, compliance with the requirements of 2012] this part. The results of each inspection must be documented, and any defi- § 121.10 Restricting access to select ciencies identified during an inspection agents and toxins; security risk as- must be corrected. sessments. (b) An entity may designate one or (a) An individual or entity required more individuals to serve as an alter- to register under this part may not nate responsible official who acts for provide an individual access to a select the responsible official in his/her ab- agent or toxin, and an individual may sence. These individuals must have the not access a select agent or toxin, un- authority and control to ensure com- less the individual is approved by the pliance with the regulations when act- Administrator or the HHS Secretary ing as the responsible official. following a security risk assessment by (c) The responsible official must re- the Attorney General. port the identification and final dis- (b) An individual will be deemed to position of any select agent or toxin have access at any point in time if the

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individual has possession of a select limited, or revoked for the reasons set agent or toxin (e.g., carries, uses, or forth in paragraphs (f)(2) through (f)(3) manipulates) or the ability to gain pos- of this section. session of a select agent or toxin. (i) An individual may appeal the Ad- (c) Each individual with access to se- ministrator’s decision to deny, limit, lect agents or toxins must have the ap- or revoke access approval under propriate education, training, and/or § 121.20. experience to handle or use such agents (j) Access approval is valid for a max- or toxins. imum of 3 years. (d) To apply for access approval, each (k) The responsible official must im- individual must submit the informa- mediately notify APHIS or CDC when tion necessary to conduct a security an individual’s access to select agents risk assessment to the Attorney Gen- or toxins is terminated by the entity eral. and the reasons therefore. (e) A person with valid approval from the HHS Secretary or Administrator to [70 FR 13284, Mar. 18, 2005, as amended at 77 FR 61079, Oct. 5, 2012] have access to select agents or toxins may request, through his or her Re- § 121.11 Security. sponsible Official, that the HHS Sec- retary or Administrator provide their (a) An individual or entity required approved access status to another reg- to register under this part must de- istered individual or entity for a speci- velop and implement a written security fied period of time. plan. The security plan must be suffi- (f) An individual’s security risk as- cient to safeguard the select agent or sessment may be expedited upon writ- toxin against unauthorized access, ten request by the responsible official theft, loss, or release. and a showing of good cause (e.g., pub- (b) The security plan must be de- lic health or agricultural emergencies, signed according to a site-specific risk national security, or a short-term visit assessment and must provide graded by a prominent researcher). A written protection in accordance with the risk decision granting or denying the re- of the select agent or toxin, given its quest will be issued. intended use. The security plan must (g) An individual’s access approval be submitted upon request. for VS select agents or toxins may be (c) The security plan must: denied, limited, or revoked if: (1) Describe procedures for physical (1) The individual is within any of security, inventory control, and infor- the categories described in 18 U.S.C. mation systems control; 175b; (2) Contain provisions for the control (2) The individual is reasonably sus- of access to select agents and toxins; pected by any Federal law enforcement (3) Contain provisions for routine or intelligence agency of committing a cleaning, maintenance, and repairs; crime set forth in 18 U.S.C. 2332b(g)(5); (4) Establish procedures for removing knowing involvement with an organi- unauthorized or suspicious persons; zation that engages in domestic or (5) Describe procedures for addressing international terrorism (as defined in loss or compromise of keys, passwords, 18 U.S.C. 2331) or with any other orga- combinations, etc. and protocols for nization that engages in intentional changing access numbers or locks fol- crimes of violence; or being an agent of lowing staff changes; a foreign power as defined in 50 U.S.C. (6) Contain procedures for reporting 1801; or unauthorized or suspicious persons or (3) It is determined that such action activities, loss or theft of select agents is necessary to protect animal health or toxins, release of select agents or or animal products. toxins, or alteration of inventory (h) For overlap select agents or tox- records; and ins, an individual’s access approval will (7) Contain provisions for ensuring be denied or revoked if the individual that all individuals with access ap- is within any of the categories de- proval from the Administrator or the scribed in 18 U.S.C. 175b. An individ- HHS Secretary understand and comply ual’s access approval may be denied, with the security procedures.

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(d) An individual or entity must ad- (8) Separate areas where select here to the following security require- agents and toxins are stored or used ments or implement measures to from the public areas of the building. achieve an equivalent or greater level (e) In developing a security plan, an of security: individual or entity should consider (1) Allow access only to individuals the document entitled, ‘‘Laboratory with access approval from the Adminis- Security and Emergency Response trator or the HHS Secretary; Guidance for Laboratories Working (2) Allow individuals not approved for with Select Agents,’’ in Morbidity and access by the Administrator or the Mortality Weekly Report (December 6, HHS Secretary to conduct routine 2002); 51 (No. RR–19):1–6. This document cleaning, maintenance, repairs, and is available on the Internet at http:// other activities not related to select www.cdc.gov/mmwr. agents or toxins only when continu- (f) The plan must be reviewed annu- ously escorted by an approved indi- ally and revised as necessary. Drills or vidual; exercises must be conducted at least (3) Provide for the control of select annually to test and evaluate the effec- agents and toxins by requiring freezers, tiveness of the plan. The plan must be refrigerators, cabinets, and other con- reviewed and revised, as necessary, tainers where select agents or toxins after any drill or exercise and after any are stored to be secured against unau- incident. thorized access (e.g., card access sys- EFFECTIVE DATE NOTE: At 77 FR 61079, Oct. tem, lock boxes); 5, 2012, § 121.11 was amended by revising para- (4) Inspect all suspicious packages graphs (b) and (c)(2); in paragraph (c)(6), by before they are brought into or re- removing the word ‘‘and’’; by adding new moved from an area where select paragraphs (c)(8), (9), and (10); by redesig- agents or toxins are used or stored; nating paragraphs (e) and (f) as paragraphs (5) Establish a protocol for intra-en- (g) and (h), respectively; by adding new para- tity transfers under the supervision of graphs (e) and (f); and by revising newly re- an individual with access approval designated paragraph (g), effective Apr. 3, 2013. For the convenience of the user, the from the Administrator or the HHS added and revised text is set forth as follows: Secretary, including chain-of-custody documents and provisions for safe- § 121.11 Security. guarding against theft, loss, or release; and * * * * * (6) Require that individuals with access approval from the Administrator (b) The security plan must be designed according to a site-specific risk assessment and or the HHS Secretary refrain from must provide graded protection in accord- sharing with any other person their ance with the risk of the select agent or unique means of accessing a select toxin, given its intended use. A current secu- agent or toxin (e.g., keycards or pass- rity plan must be submitted for initial reg- words); istration, renewal of registration, or when (7) Require that individuals with ac- requested. cess approval from the Administrator (c) * * * or the HHS Secretary immediately re- (2) Contain provisions for the control of ac- port any of the following to the respon- cess to select agents and toxins, including the safeguarding of animals or plants inten- sible official: tionally or accidentally exposed to or in- (i) Any loss or compromise of keys, fected with a select agent, against unauthor- passwords, combinations, etc.; ized access, theft, loss or release. (ii) Any suspicious persons or activities; * * * * * (iii) Any loss or theft of select agents or toxins; (8) Describe procedures for how the respon- (iv) Any release of a select agent or sible official will be informed of suspicious toxin; and activity that may be criminal in nature and related to the entity, its personnel, or its se- (v) Any sign that inventory or use lect agents or toxins; and describe proce- records for select agents or toxins have dures for how the entity will notify the ap- been altered or otherwise com- propriate Federal, State, or local law en- promised; and forcement agencies of such activity.

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(9) Contain provisions for information se- entity possessing a Tier 1 select agent or curity that: toxin must also: (i) Ensure that all external connections to (1) Describe procedures for conducting a systems which manage security for the reg- pre-access suitability assessment of persons istered space are isolated or have controls who will have access to a Tier 1 select agent that permit only authorized and authenti- or toxin; cated users; (2) Describe procedures for how an entity’s (ii) Ensure that authorized and authenti- responsible official will coordinate their ef- cated users are only granted access to select forts with the entity’s safety and security agent and toxin related information, files, professionals to ensure security of Tier 1 se- equipment (e.g., servers or mass storage de- lect agents and toxins and share, as appro- vices), and applications as necessary to ful- priate, relevant information; and fill their roles and responsibilities, and that (3) Describe procedures for the ongoing as- access is modified when the user’s roles and sessment of the suitability of personnel with responsibilities change or when their access access to a Tier 1 select agent or toxin. The to select agents and toxins is suspended or procedures must include: revoked; (i) Self- and peer-reporting of incidents or (iii) Ensure that controls are in place that conditions that could affect an individual’s are designed to prevent malicious code (such ability to safely have access to or work with as, but not limited to, computer viruses, select agents and toxins, or to safeguard se- worms, spyware) from compromising the lect agents and toxins from theft, loss, or re- confidentiality, integrity, or availability of lease; (ii) The training of employees with access information systems which manage access to to Tier 1 select agents and toxins on entity spaces registered under this part or records policies and procedures for reporting, evalua- as specified in § 121.17; tion, and corrective actions concerning the (iv) Establish a robust configuration man- assessment of personnel suitability; and agement practice for information systems to (iii) The ongoing suitability monitoring of include regular patching and updates made individuals with access to Tier 1 select to operating systems and individual applica- agents and toxins. tions; and (4) Entities with Tier 1 select agents and (v) Establish procedures that provide toxins must prescribe the following security backup security measures in the event that enhancements: access control systems, surveillance devices, (i) Procedures that will limit access to a and/or systems that manage the require- Tier 1 select agent or toxin to only those in- ments of § 121.17 are rendered inoperable. dividuals who are approved by the HHS Sec- (10) Contain provisions and policies for retary or Administrator following a security shipping, receiving, and storage of select risk assessment by the Attorney General, agents and toxins, including documented have had an entity-conducted pre-access procedures for receiving, monitoring, and suitability assessment, and are subject to shipping of all select agents and toxins. the entity’s procedures for ongoing suit- These provisions must provide that an entity ability assessment; will properly secure containers on site and (ii) Procedures that limit access to labora- have a written contingency plan for unex- tory and storage facilities outside of normal pected shipments. business hours to only those specifically approved by the responsible official or des- * * * * * ignee; (iii) Procedures for allowing visitors, their (e) Entities must conduct complete inven- property, and vehicles at the entry and exit tory audits of all affected select agents and points to the registered space, or at other toxins in long-term storage when any of the designated points of entry to the building, following occur: facility, or compound that are based on the (1) Upon the physical relocation of a col- entity’s site-specific risk assessment; lection or inventory of select agents or tox- (iv) A minimum of three security barriers ins for those select agents or toxins in the where each security barrier adds to the delay collection or inventory; in reaching secured areas where select (2) Upon the departure or arrival of a prin- agents and toxins are used or stored. One of cipal investigator for those select agents and the security barriers must be monitored in toxins under the control of that principal in- such a way as to detect intentional and unin- vestigator; or tentional circumventing of established ac- (3) In the event of a theft or loss of a select cess control measures under all conditions agent or toxin, all select agents and toxins (day/night, severe weather, etc.) The final under the control of that principal investi- barrier must limit access to the select agent gator. or toxin to personnel approved by the HHS (f) In addition to the requirements con- Secretary or Administrator, following a se- tained in paragraphs (c) and (d) of this sec- curity risk assessment by the Attorney Gen- tion, the security plan for an individual or eral.

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(v) All registered space or areas that rea- given its intended use. 9 The biosafety sonably afford access to the registered space plan must contain sufficient informa- must be protected by an intrusion detection tion and documentation to describe the system (IDS) unless physically occupied; biosafety and containment procedures. (vi) Personnel monitoring the IDS must be (b) The biosafety and containment capable of evaluating and interpreting the alarm and alerting the designated security procedures must be sufficient to con- response force or law enforcement; tain the select agent or toxin (e.g., (vii) For powered access control systems, physical structure and features of the describe procedures to ensure that security entity, and operational and procedural is maintained in the event of the failure of safeguards). access control systems due to power disrup- (c) In developing a biosafety plan, an tion affecting registered space; individual or entity should consider (viii) The entity must: the following: (A) Determine that the response time for (1) The CDC/NIH publication, ‘‘Bio- security forces or local police will not exceed safety in Microbiological and Bio- 15 minutes where the response time is measured from the time of an intrusion alarm, or medical Laboratories.’’ This document report of a security incident, to the arrival may be obtained from the U.S. Govern- of the responders at the first security barrier ment Printing Office. It is also avail- or; able on the Internet at http:// (B) Provide security barriers that are suffi- www.aphis.usda.gov/programs/ cient to delay unauthorized access until the aglselectagent/index.html. response force arrives in order to safeguard (2) The Occupational Safety and the select agents and toxins from theft, in- Health Administration (OSHA) regula- tentional release, or unauthorized access. tions in 29 CFR 1910.1200 and 1910.1450. The response time is measured from the time (3) The ‘‘NIH Guidelines for Research of an intrusion alarm, or report of a security incident, to the arrival of the responders at Involving Recombinant DNA Mol- the first security barrier. ecules.’’ This document is available on (5) Entities that possess foot-and-mouth the Internet at http:// disease virus and rinderpest virus must have www.aphis.usda.gov./programs/ the following additional security require- aglselectagent/index.html. ments: (d) The plan must be reviewed annu- (i) A minimum of four barriers, one of ally and revised as necessary. Drills or which must be a perimeter security fence or exercises must be conducted at least equivalent which is monitored 24 hours a annually to test and evaluate the effec- day, 7 days a week (24/7) to detect the pres- tiveness of the plan. The plan must be ence of unauthorized persons, vehicles, materials, or unauthorized activities; reviewed and revised, as necessary, (ii) Onsite 24/7 armed security response after any drill or exercise and after any force with roving patrol. Response time must incident. not exceed 5 minutes from the time of an in- [70 FR 13284, Mar. 18, 2005, as amended at 73 trusion alarm or report of a security inci- FR 61331, Oct. 16, 2008] dent; (iii) CCTV surveillance with 24/7 moni- EFFECTIVE DATE NOTE: At 77 FR 61080, Oct. toring and recording; and 5, 2012, § 121.12 was amended by revising para- (iv) Transport vehicle with GPS tracking graphs (a) and (c)(1); adding a second sen- designed to serve as a containment vehicle. tence to paragraph (c)(2); in paragraph (c)(3), (g) In developing a security plan, an indi- by removing the address ‘‘http:// vidual or entity should consider the docu- www.aphis.usda.gov/programs/aglselectagent/ ment entitled, ‘‘Security Guidance for Select index.html ’’ and adding in its place ‘‘http:// Agent or Toxin Facilities.’’ This document is www.selectagents.gov/ ’’; by redesignating available on the Internet at http:// paragraph (d) as paragraph (e); and by adding www.selectagents.gov/. a new paragraph (d), effective Apr. 3, 2013. For the convenience of the user, the added and revised text is set forth as follows: * * * * * § 121.12 Biosafety. § 121.12 Biosafety. (a) An individual or entity required to register under this part must develop and imple- (a) An individual or entity required ment a written biosafety plan that is com- to register under this part must de- mensurate with the risk of the select agent velop and implement a written biosafety plan that is commensurate with 9 Technical assistance and guidance may be the risk of the select agent or toxin, obtained by contacting APHIS.

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or toxin, given its intended use.9 The bio- binant nucleic acids containing genes safety plan must contain sufficient informa- for the biosynthesis of select toxins le- tion and documentation to describe the bio- thal for vertebrates at an LD[50]<100 safety and containment procedures for the select agent or toxin, including any animals ng/kg body weight. (including arthropods) or plants inten- (c) The Administrator may revoke tionally or accidentally exposed to or in- approval to conduct any of the experi- fected with a select agent. ments in paragraph (b) of this section, or revoke or suspend a certificate of * * * * * registration, if the individual or entity (c) * * * fails to comply with the requirements (1) The CDC/NIH publication, ‘‘Biosafety in of this part. Microbiological and Biomedical Labora- (d) To apply for approval to conduct tories.’’ This document is available on the any of the experiments in paragraph (b) National Select Agent Registry at http:// www.selectagents.gov/. of this section, an individual or entity (2) * * * This document is available on the must submit a written request and sup- National Select Agent Registry at http:// porting scientific information. A writ- www.selectagents.gov/. ten decision granting or denying the request will be issued. * * * * * [70 FR 13284, Mar. 18, 2005, as amended at 73 (d) The biosafety plan must include an oc- FR 61331, Oct. 16, 2008; 77 FR 61080, Oct. 5, cupational health program for individuals 2012] with access to Tier 1 select agents and toxins, and those individuals must be enrolled § 121.14 Incident response. 11 in the occupational health program. (a) An individual or entity required * * * * * to register under this part must develop and implement a written inci- § 121.13 Restricted experiments. dent response plan. 12 The incident re- (a) An individual or entity may not sponse plan must be coordinated with conduct, or possess products (i.e., select any entity-wide plans, kept in the agents that are not known to acquire a workplace, and available to employees drug resistance trait naturally, if such for review. acquisition could compromise the con- (b) The incident response plan must trol of disease agents in humans, vet- fully describe the entity’s response pro- erinary medicine, or agriculture, or re- cedures for the theft, loss, or release of combinant and/or synthetic nucleic a select agent or toxin; inventory dis- acids containing genes for the bio- crepancies; security breaches (includ- synthesis of select toxins lethal for ing information systems); severe vertebrates at an LD[50] < 100 ng/kg weather and other natural disasters; body weight) resulting from, the fol- workplace violence; bomb threats and lowing experiments unless approved by suspicious packages; and emergencies and conducted in accordance with the such as fire, gas leak, explosion, power conditions prescribed by the Adminis- outage, etc. The response procedures trator: must account for hazards associated (b) Restricted experiments: (1) Experi- with the select agent or toxin and ap- ments that involve the deliberate propriate actions to contain such agent transfer of, or selection for, a drug resistance trait to select agents that are or toxin. not known to acquire the trait natu- (c) The incident response plan must rally, if such acquisition could com- also contain the following information: promise the control of disease agents in humans, veterinary medicine, or agriculture. 11 (2) Experiments involving the delib- Nothing in this section is meant to supersede or preempt incident response re- erate formation of synthetic or recom- quirements imposed by other statutes or regulations. 9 Technical assistance and guidance may be 12 Technical assistance and guidance may obtained by contacting APHIS. be obtained by contacting APHIS.

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(1) The name and contact informa- § 121.14 Incident response.10 tion (e.g., home and work) for the indi- (a) An individual or entity required to reg- vidual or entity (e.g., responsible offi- ister under this part must develop and imple- 11 cial, alternate responsible official(s), ment a written incident response plan based upon a site specific risk assessment. biosafety officer, etc.); *** (2) The name and contact informa- (b) The incident response plan must fully tion for the building owner and/or man- describe the entity’s response procedures for ager, where applicable; the theft, loss, or release of a select agent or (3) The name and contact informa- toxin; inventory discrepancies; security breaches (including information systems); tion for tenant offices, where applica- severe weather and other natural disasters; ble; workplace violence; bomb threats and sus- (4) The name and contact informa- picious packages; and emergencies such as tion for the physical security official fire, gas leak, explosion, power outage, and for the building, where applicable; other natural and man-made events. (c) The response procedures must account (5) Personnel roles and lines of au- for hazards associated with the select agent thority and communication; or toxin and appropriate actions to contain (6) Planning and coordination with such select agent or toxin, including any ani- local emergency responders; mals (including arthropods) or plants intentionally or accidentally exposed to or in- (7) Procedures to be followed by em- fected with a select agent. ployees performing rescue or medical duties; * * * * * (8) Emergency medical treatment and first aid; (e) Entities with Tier 1 select agents and toxins must have the following additional in- (9) A list of personal protective and cident response policies or procedures: emergency equipment, and their loca- (1) The incident response plan must fully tions; describe the entity’s response procedures for (10) Site security and control; failure of intrusion detection or alarm system; and (11) Procedures for emergency evacu- (2) The incident response plan must de- ation, including type of evacuation, scribe procedures for how the entity will no- exit route assignments, safe distances, tify the appropriate Federal, State, or local and places of refuge; and law enforcement agencies of suspicious ac- (12) Decontamination procedures. tivity that may be criminal in nature and related to the entity, its personnel, or its se- (d) The plan must be reviewed annu- lect agents or toxins. ally and revised as necessary. Drills or exercises must be conducted at least * * * * * annually to test and evaluate the effectiveness of the plan. The plan must be § 121.15 Training. reviewed and revised, as necessary, (a) An individual or entity required after any drill or exercise and after any to register under this part must pro- incident. vide information and training on bio- [70 FR 13284, Mar. 18, 2005, as amended at 73 safety and security to each individual FR 61331, Oct. 16, 2008] with access approval from the Adminis- trator or the HHS Secretary before he/ EFFECTIVE DATE NOTE: At 77 FR 61080, Oct. she has such access. In addition, an in- 5, 2012, § 121.14 was amended in the section dividual or entity must provide infor- heading by redesignating footnote 11 as foot- mation and training on biosafety and note 10; in paragraph (a), by redesignating security to each individual not ap- footnote 12 as footnote 11 and revising the first sentence of the paragraph; by revising proved for access by the Administrator paragraph (b); by redesignating paragraphs or the HHS Secretary before he/she (c) and (d) as paragraphs (d) and (f), respec- works in or visits areas where select tively; and by adding new paragraphs (c) and (e), effective Apr. 3, 2013. For the conven- 10 Nothing in this section is meant to su- ience of the user, the added and revised text persede or preempt incident response re- is set forth as follows: quirements imposed by other statutes or regulations. 11 Technical assistance and guidance may be obtained by contacting APHIS.

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agents or toxins are handled or stored entity significantly amends its security, in- (e.g., laboratories, growth chambers, cident response, or biosafety plans. animal rooms, greenhouses, storage (d) The responsible official must ensure a record of the training provided to each indi- areas, etc.). The training must address vidual with access to select agents and tox- the particular needs of the individual, ins and each escorted individual (e.g., labora- the work they will do, and the risks tory workers, visitors, etc.) is maintained. posed by the select agents or toxins. 13 The record must include the name of the in- (b) Refresher training must be pro- dividual, the date of the training, a descrip- vided annually. tion of the training provided, and the means (c) A record of the training provided used to verify that the employee understood to each individual must be maintained. the training. The record must include the name of § 121.16 Transfers. the individual, the date of training, a description of the training provided, (a) Except as provided in paragraphs and the means used to verify that the (c) and (d) of this section, a select employee understood the training. agent or toxin may only be transferred to individuals or entities registered to [70 FR 13284, Mar. 18, 2005, as amended at 73 possess, use, or transfer that agent or FR 61331, Oct. 16, 2008] toxin. A select agent or toxin may only EFFECTIVE DATE NOTE: At 77 FR 61081, Oct. be transferred under the conditions of 5, 2012, § 121.15 was revised, effective Apr. 3, this section and must be authorized by 2013. For the convenience of the user, the re- APHIS or CDC prior to the transfer. 12 vised text is set forth as follows: (b) In addition to any permit required § 121.15 Training. under part 122 of this subchapter, a transfer may be authorized if: (a) An individual or entity required to register under this part must provide informa- (1) The sender: tion and training on biosafety, security (in- (i) Has at the time of transfer a cer- cluding security awareness), and incident re- tificate of registration that covers the sponse to: particular select agent or toxin to be (1) Each individual with access approval transferred and meets all the require- from the HHS Secretary or Administrator ments of this part; before that individual has such access to se- (ii) Meets the exemption require- lect agents and toxins. The training must ad- ments for the particular select agent or dress the particular needs of the individual, toxin to be transferred; or the work they will do, and the risks posed by the select agents or toxins; and (iii) Is transferring the select agent (2) Each individual not approved for access or toxin from outside of the United to select agents and toxins by the HHS Sec- States and meets all import require- retary or Administrator before that indi- ments. vidual enters areas where select agents or (2) At the time of transfer, the recipi- toxins are handled or stored (e.g., labora- ent has a certificate of registration tories, growth chambers, animal rooms, that includes the particular select greenhouses, storage areas, shipping/receiv- agent or toxin to be transferred and ing areas, production facilities, etc.). Train- meets all of the requirements of this ing for escorted personnel must be based on the risk associated with accessing areas part. where select agents and toxins are used and/ (c) A select agent or toxin that is or stored. contained in a specimen for proficiency (b) Entities with Tier 1 select agents and testing may be transferred without toxins must conduct annual insider threat prior authorization from APHIS or awareness briefings on how to identify and CDC provided that, at least 7 calendar report suspicious behaviors. days prior to the transfer, the sender (c) Refresher training must be provided an- reports to APHIS or CDC the select nually for individuals with access approval from the HHS Secretary or Administrator or agent or toxin to be transferred and at such time as the registered individual or the name and address of the recipient. (d) On a case-by-case basis, the Ad- 13 For guidance, see the CDC/NIH publica- ministrator may authorize a transfer tion, ‘‘Biosafety in Microbiological and Bio- medical Laboratories.’’ This document is 12 The requirements of this section do not available on the Internet at http:// apply to transfers within a registered entity www.aphis.usda.gov/programs/aglselectagent/ (i.e., the sender and the recipient are covered index.html. by the same certificate of registration).

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of a select agent or toxin not otherwise activities covered by this part. Such eligible for transfer under this part records must include: under conditions prescribed by the Ad- (1) An accurate, current inventory ministrator. for each select agent (including viral (e) To obtain authorization for a genetic elements, recombinant and/or transfer, APHIS/CDC Form 2 must be synthetic nucleic acids, and organisms submitted. containing recombinant and/or syn- (f) After authorization is provided by thetic nucleic acids) held in long-term APHIS or CDC, the packaging of the storage (placement in a system de- select agent(s) and toxin(s) is per- signed to ensure viability for future formed by an individual approved by use, such as in a freezer or lyophilized the HHS Secretary or Administrator to materials), including: have access to select agents and toxins (i) The name and characteristics and is in compliance with all applica- (e.g., strain designation, GenBank Ac- ble laws concerning packaging. cession number, etc.); (g) The sender must comply with all (ii) The quantity acquired from an- applicable laws governing shipping. other individual or entity (e.g., con- (h) Transportation in commerce tainers, vials, tubes, etc.), date of ac- starts when the select agent(s) or quisition, and the source; toxin(s) are packaged for shipment and (iii) Where stored (e.g., building, ready for receipt by a courier trans- room, and freezer); porting select agent(s) or toxin(s) and (iv) When moved from storage and by ends when the package is received by whom and when returned to storage the intended recipient who is an indi- and by whom; vidual approved by the HHS Secretary or Administrator to have access to se- (v) The select agent used and purpose lect agents and toxins, following a se- of use; curity risk assessment by the Attorney (vi) Records created under § 121.16 or General. 42 CFR 73.16 (Transfers); (i) The recipient must submit a com- (vii) For intra-entity transfers (send- pleted APHIS/CDC Form 2 within 2 er and the recipient are covered by the business days of receipt of a select same certificate of registration), the agent or toxin. select agent, the quantity transferred, (j) The recipient must immediately the date of transfer, the sender, and notify APHIS or CDC if the select the recipient; and agent or toxin has not been received (viii) Records created under § 121.19 or within 48 hours after the expected de- 42 CFR 73.19 (Notification of theft, loss, livery time or if the package con- or release); taining the select agent or toxin has (2) An accurate, current accounting been damaged to the extent that a re- of any animals or plants intentionally lease of the select agent or toxin may or accidentally exposed to or infected have occurred. with a select agent (including number (k) An authorization for a transfer and species, location, and appropriate shall be valid only for 30 calendar days disposition); after issuance, except that such an au- (3) An accurate, current inventory thorization becomes immediately null for each toxin held, including: and void if any facts supporting the au- (i) The name and characteristics; thorization change (e.g., change in the (ii) The quantity acquired from an- certificate of registration for the send- other individual or entity (e.g., con- er or recipient, change in the applica- tainers, vials, tubes, etc.), date of action for transfer). quisition, and the source; [70 FR 13284, Mar. 18, 2005, as amended at 73 (iii) The initial and current quantity FR 61331, Oct. 16, 2008; 77 FR 61081, Oct. 5, amount (e.g., milligrams, milliliters, 2012] grams, etc.); (iv) The toxin used and purpose of § 121.17 Records. use, quantity, date(s) of the use and by (a) An individual or entity required whom; to register under this part must main- (v) Where stored (e.g., building, room, tain complete records relating to the and freezer);

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(vi) When moved from storage and by premises and records to ensure compli- whom and when returned to storage ance with this part. and by whom, including quantity amount; § 121.19 Notification of theft, loss, or (vii) Records created under § 121.16 or release. 42 CFR 73.16 (Transfers); (a) An individual or entity must im- (viii) For intra-entity transfers mediately notify APHIS or CDC upon (sender and the recipient are covered discovery of the theft or loss of a select by the same certificate of registra- agent or toxin. Thefts or losses must be tion), the toxin, the quantity trans- reported even if the select agent or ferred, the date of transfer, the sender, toxin is subsequently recovered or the and the recipient; responsible parties are identified. (ix) Records created under § 121.19 or (1) The theft or loss of a select agent 42 CFR 73.19 (Notification of theft, loss, or toxin must be reported by telephone, or release); facsimile, or e-mail. The following in- (x) If destroyed, the quantity of toxin formation must be provided: destroyed, the date of such action, and (i) The name of the select agent or by whom. toxin and any identifying information (4) A current list of all individuals (e.g., strain or other characterization that have been granted access approval information); by the Administrator or the HHS Sec- retary; (ii) An estimate of the quantity sto- (5) Information about all entries into len or lost; areas containing select agents or tox- (iii) An estimate of the time during ins, including the name of the indi- which the theft or loss occurred; vidual, name of the escort (if applica- (iv) The location (building, room) ble), and the date and time of entry; from which the theft or loss occurred; (6) Accurate, current records created and under § 121.9 or 42 CFR 73.9 (Responsible (v) The list of Federal, State, or local official), § 121.11 or 42 CFR 73.11 (Secu- law enforcement agencies to which the rity), § 121.12 or 42 CFR 73.12 (Bio- individual or entity reported, or in- safety), § 121.14 or 42 CFR 73.14 (Incident tends to report, the theft or loss. response), and § 121.15 or 42 CFR 73.15 (2) A completed APHIS/CDC Form 3 (Training); and must be submitted within 7 calendar (7) A written explanation of any dis- days. crepancies. (b) An individual or entity must im- (b) The individual or entity must immediately notify APHIS or CDC upon plement a system to ensure that all discovery of a release of a select agent records and databases created under or toxin causing occupational exposure this part are accurate, have controlled or a release of a select agent or toxin access, and that their authenticity outside of the primary barriers of the may be verified. biocontainment area. (c) All records created under this (1) The release of a select agent or part must be maintained for 3 years toxin must be reported by telephone, and promptly produced upon request. facsimile, or e-mail. The following in- [70 FR 13284, Mar. 18, 2005, as amended at 77 formation must be provided: FR 61081, Oct. 5, 2012] (i) The name of the select agent or toxin and any identifying information § 121.18 Inspections. (e.g., strain or other characterization (a) Without prior notification, APHIS information); must be allowed to inspect any site at (ii) An estimate of the quantity re- which activities regulated under this leased; part are conducted and must be al- (iii) The time and duration of the re- lowed to inspect and copy any records lease; relating to the activities covered by (iv) The environment into which the this part. release occurred (e.g., in building or (b) Prior to issuing a certificate of outside of building, waste system); registration to an individual or entity, (v) The location (building, room) APHIS may inspect and evaluate the from which the release occurred; and

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(vi) The number of individuals poten- which may introduce or disseminate tially exposed at the entity; any contagious or infectious disease of (vii) Actions taken to respond to the animals (including poultry). release; and (e) Vectors. All animals (including (viii) Hazards posed by the release. poultry) such as mice, pigeons, guinea (2) A completed APHIS/CDC Form 3 pigs, rats, ferrets, rabbits, chickens, must be submitted within 7 calendar dogs, and the like, which have been days. treated or inoculated with organisms, § 121.20 Administrative review. or which are diseased or infected with any contagious, infectious, or commu- (a) An individual or entity may ap- nicable disease of animals or poultry or peal a denial, revocation, or suspension which have been exposed to any such of registration under this part. The ap- disease. peal must be in writing, state the factual basis for the appeal, and be sub- (f) Permittee. A person who resides in mitted to the Administrator within 30 the United States or operates a busi- calendar days of the decision. ness establishment within the United (b) An individual may appeal a de- States, to whom a permit to import or nial, limitation, or revocation of access transport organisms or vectors has approval under this part. The appeal been issued under the regulations. must be in writing, state the factual (g) Person. Any individual, firm, part- basis for the appeal, and be submitted nership, corporation, company, society, to the Administrator within 180 cal- association, or other organized group endar days of the decision. of any of the foregoing, or any agent, (c) The Administrator’s decision con- officer, or employee of any thereof. stitutes final agency action. [31 FR 81, Jan. 5, 1966, as amended at 57 FR [77 FR 61081, Oct. 5, 2012] 30899, July 13, 1992] PART 122—ORGANISMS AND § 122.2 Permits required. VECTORS No organisms or vectors shall be imported into the United States or trans- Sec. ported from one State or Territory or 122.1 Definitions. the District of Columbia to another 122.2 Permits required. 122.3 Application for permits. State or Territory or the District of 122.4 Suspension or revocation of permits. Columbia without a permit issued by the Secretary and in compliance with AUTHORITY: 7 U.S.C. 8301–8317; 21 U.S.C. 151– 158; 7 CFR 2.22, 2.80, and 371.4. the terms thereof: Provided, That no permit shall be required under this sec- § 122.1 Definitions. tion for importation of organisms for The following words, when used in which an import permit has been the regulations in this part 122, shall issued pursuant to part 102 of this sub- be construed, respectively, to mean: chapter or for transportation of orga- (a) Department. The U.S. Department nisms produced at establishments li- of Agriculture. censed under part 102 of this sub- (b) Secretary. ‘‘Secretary’’ means the chapter. As a condition of issuance of Secretary of Agriculture of the United permits under this section, the per- States, or any officer or employee of mittee shall agree in writing to observe the Department to whom authority has the safeguards prescribed by the Ad- heretofore been delegated, or to whom ministrator for public protection with authority may hereafter be delegated, respect to the particular importation to act in his stead. or transportation. (c) Administrator. The Administrator, Animal and Plant Health Inspection (Approved by the Office of Management and Service, United States Department of Budget under control number 0579–0015) Agriculture, or any person authorized [28 FR 7896, Aug. 2, 1963. Redesignated at 31 to act for the Administrator. FR 81, Jan. 5, 1966 and amended at 48 FR (d) Organisms. All cultures or collec- 57473, Dec. 30, 1983; 57 FR 30899, July 13, 1992; tions of organisms or their derivatives, 59 FR 67134, Dec. 29, 1994]

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§ 122.3 Application for permits. PART 123—RULES OF PRACTICE The Secretary may issue, at his dis- GOVERNING PROCEEDINGS cretion, a permit as specified in § 122.2 UNDER THE VIRUS-SERUM-TOXIN when proper safeguards are set up as ACT provided in § 122.2 to protect the public.

Application for such a permit shall be AUTHORITY: 7 U.S.C. 8301–8317; 21 U.S.C. 151– made in advance of shipment, and each 159; 7 CFR 2.22, 2.80, and 371.4. permit shall specify the name and address of the consignee, the true name § 123.1 Scope and applicability of rules and character of each of the organisms of practice. or vectors involved, and the use to The Uniform Rules of Practice for which each will be put. the Department of Agriculture promulgated in subpart H of part 1, subtitle A, (Approved by the Office of Management and title 7, Code of Federal Regulations, Budget under control number 0579–0015) are the Rules of Practice applicable to [23 FR 10065, Dec. 23, 1958. Redesignated at 31 adjudicatory, administrative pro- FR 81, Jan. 5, 1966 and amended at 48 FR ceedings under the Virus-Serum-Toxin 57473, Dec. 30, 1983; 59 FR 67134, Dec. 29, 1994] Act. § 122.4 Suspension or revocation of [42 FR 10960, Feb. 25, 1977] permits. (a) Any permit for the importation or PART 124—PATENT TERM transportation of organisms or vectors RESTORATION issued under this part may be formally suspended or revoked after opportunity Subpart A—General Provisions for hearing has been accorded the per- Sec. mittee, as provided in part 123 of this 124.1 Scope. subchapter, if the Secretary finds that 124.2 Definitions. the permittee has failed to observe the safeguards and instructions prescribed Subpart B—Eligibility Assistance by the Administrator with respect to 124.10 APHIS liaison with PTO. the particular importation or transportation or that such importation or Subpart C—Regulatory Review Period transportation for any other reason 124.20 Patent term extension calculation. may result in the introduction or dis- 124.21 Regulatory review period determina- semination from a foreign country into tion. the United States, or from one State, 124.22 Revision of regulatory review period Territory or the District of Columbia determination. to another, of the contagion of any 124.23 Final action on regulatory review pe- contagious, infectious or commu- riod determination. nicable disease of animals (including Subpart D—Due Diligence Petitions poultry). (b) In cases of wilfulness or where the 124.30 Filing, format, and content of peti- public health, interest or safety so re- tions. quires, however, the Secretary may 124.31 Applicant response to petition. 124.32 APHIS action on petition. without hearing informally suspend 124.33 Standard of due diligence. such a permit upon the grounds set forth in paragraph (a) of this section, Subpart E—Due Diligence Hearing pending determination of formal proceedings under part 123 of this sub- 124.40 Request for hearing. 124.41 Notice of hearing. chapter for suspension or revocation of 124.42 Hearing procedure. the permit. 124.43 Administrative decision.

[23 FR 10065, Dec. 23, 1958. Redesignated at 31 AUTHORITY: 35 U.S.C. 156; 7 CFR 2.22, 2.80, FR 81, Jan. 5, 1966, and amended at 57 FR and 371.4. 30899, July 13, 1992] SOURCE: 58 FR 11369, Feb. 25, 1993, unless otherwise noted.

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Subpart A—General Provisions local government agency, or other organized group of any of the foregoing, § 124.1 Scope. or any agent, officer, or employee of (a) This parts sets forth procedures any thereof. and requirements for APHIS review of PTO. The Patent and Trademark Of- applications for the extension of the fice of the United States Department of term of certain patents for veterinary Commerce. biological products pursuant to 35 U.S.C. 156—Extension of patent term. [58 FR 11369, Feb. 25, 1993, as amended at 68 Responsibilities of APHIS include: FR 6346, Feb. 7, 2003] (1) Assisting PTO in determining eligibility for patent term restoration; Subpart B—Eligibility Assistance (2) Determining the length of a product’s regulatory review period; § 124.10 APHIS liaison with PTO. (3) If petitioned, reviewing and ruling Upon receipt of a copy of an applica- on due diligence challenges to APHIS’s tion for extension of the term of a vet- regulatory review period determina- erinary biologic patent from PTO, tions; and APHIS will assist PTO in determining (4) Conducting hearings to review ini- whether a patent related to a biologi- tial APHIS findings on due diligence cal product is eligible for patent term challenges. (b) The regulations in this part are extension by: designed to be used in conjunction with (a)(1) Verifying whether the product regulations issued by PTO concerning was subject to a regulatory review pe- patent term extension which may be riod before its commercial marketing found at 37 CFR 1.710 through 1.791. or use; (2) Determining whether the permis- [58 FR 11369, Feb. 25, 1993, as amended at 64 FR 43045, Aug. 9, 1999] sion for commercial marketing or use of the product after the regulatory re- § 124.2 Definitions. view period was the first permitted Animal and Plant Health Inspection commercial marketing or use of the Service (APHIS). The agency in the De- product under the provision of law partment of Agriculture responsible for under which such regulatory review pe- licensing veterinary biological prod- riod occurred, and, if so, whether it was ucts under the Virus-Serum-Toxin Act. the first permitted commercial mar- Applicant. Any person who submits keting or use of the veterinary biologi- an application or an amendment or cal product for administration to a supplement to an application under 35 food-producing animal; U.S.C. 156 seeking extension of the (3) Ascertaining whether the patent term of a patent. term restoration application was sub- Due diligence petition. A petition submitted within 60 days after the product mitted under § 124.30 of this part. was approved for marketing or use; and Informal hearing. A hearing that is not subject to the provisions of 5 U.S.C. (4) Providing such other information 554, 556, and 557 and that is conducted as may be necessary and relevant to as provided in 21 U.S.C. 321(x). PTO’s determination of whether a pat- License applicant. Any person who, in ent related to a product is eligible for accordance with part 102 of this chap- patent term restoration. ter, submits an application to the Ani- (b) APHIS will notify PTO of its find- mal and Plant Health Inspection Serv- ings in writing, send a copy of this no- ice of the U.S. Department of Agri- tification to the applicant, and make a culture for a U.S. Veterinary Biologi- copy available for public inspection in cal Product License. room 1141, South Building, 14th Street Patent. A patent issued by the Patent and Independence Avenue SW., Wash- and Trademark Office of the United ington, DC, between 8 a.m. and 4:30 States Department of Commerce. p.m., Monday through Friday, except Person. Any individual, firm, partner- holidays. ship, corporation, company, association, educational institution, State or

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Subpart C—Regulatory Review (2) The trade name and true name of Period the product; (3) The number of the patent for § 124.20 Patent term extension calcula- which an extension of the term is tion. sought; (a) As provided in 37 CFR 1.779 of (4) The approved indications or uses PTO’s regulations, in order to deter- for the product; mine a product’s regulatory review pe- (5) The regulatory review period de- riod, APHIS will review the informa- termination, including a statement of tion in each application to determine the length of each phase of the review the lengths of the following phases of period and the dates used in calcu- the review period, and will then find lating each phase. their sum: (1) The number of days in the period § 124.22 Revision of regulatory review beginning on the date authorization to period determination. prepare an experimental biological (a) Any interested person may re- product under the Virus-Serum-Toxin quest a revision of the regulatory re- Act became effective and ending on the view period determination within the date an application for a license was 30 day period beginning on its publica- initially submitted under the Virus- tion in the FEDERAL REGISTER. The re- Serum-Toxin Act; and quest must be sent to the Director, (2) The number of days in the period Center for Veterinary Biologics, Pol- beginning on the date an application icy, Evaluation, and Licensing, 1920 for a license was initially submitted Dayton Avenue, P.O. Box 844, Ames, IA for approval under the Virus-Serum- 50010. The request must specify the fol- Toxin Act and ending on the date such lowing: license was issued. (1) The identity of the product; (b) A license application is ‘‘initially (2) The identity of the applicant for submitted’’ on the date it contains suf- patent term restoration; ficient information to allow APHIS to (3) The docket number of the FED- commence review of the application. A ERAL REGISTER notice announcing the product license is issued on the date of regulatory review period determina- the APHIS letter informing the appli- tion; and cant of the issuance. The issuance of a license releases the product for com- (4) The basis for the request for revi- mercial marketing or use. sion, including any documentary evidence. § 124.21 Regulatory review period de- (b) If APHIS decides to revise its termination. prior determination, APHIS will notify (a) Not later than 30 days after the PTO of the decision, and will send a receipt of an application from PTO, copy of notification to the applicant APHIS shall determine the regulatory and the person requesting the revision review period. Once the regulatory re- (if different from the applicant) with a view period for a product has been de- request for comments within 10 days of termined, APHIS will notify PTO in notification. If no comment on the pro- writing of the determination, send a posed revision is received, APHIS will copy of the determination to the appli- publish the revision in the FEDERAL cant, and make a copy available for REGISTER, and include a statement giv- public inspection in room 1141, South ing the reasons for the revision. If com- Building, 14th Street and Independence ment is received, APHIS will make a Avenue SW., Washington, DC, between final determination regarding the revi- 8 a.m. and 4:30 p.m., Monday through sion based on such comment and will Friday, except holidays. then publish the revision in the FED- (b) APHIS will also publish a notice ERAL REGISTER, giving reasons for its of the regulatory review period deter- determination. mination in the FEDERAL REGISTER. [59 FR 11369, Feb. 25, 1993, as amended at 59 The notice will include the following: FR 67617, Dec. 30, 1994; 64 FR 43045, Aug. 9, (1) The name of the applicant; 1999; 75 FR 20773, Apr. 21, 2010]

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§ 124.23 Final action on regulatory re- § 124.31 Applicant response to petition. view period determination. (a) The applicant may file with APHIS will consider its regulatory APHIS a written response to the peti- review period determination to be final tion no later than 20 days after the ap- upon expiration of the 180-day period plicant’s receipt of a copy of the peti- for filing a due diligence petition under tion. § 124.30 unless it receives: (b) The applicant’s response may (a) New information from PTO present additional facts and cir- records, or APHIS records, that affects cumstances to address the assertions in the regulatory review period deter- the petition, but shall be limited to the mination; issue of whether the applicant acted (b) A request under § 124.22 for revi- with due diligence during the regu- sion of the regulatory review period de- latory review period. The applicant’s termination; response may include documents that (c) A due diligence petition filed were not in the original patent term under § 124.30; or extension application. (d) A request for a hearing filed under (c) If the applicant does not respond § 124.40. to the petition, APHIS will decide the matter on the basis of the information [58 FR 11369, Feb. 25, 1993; 58 FR 29028, May 18, 1993] submitted in the patent term restoration application, the due diligence petition, and APHIS records. Subpart D—Due Diligence Petitions § 124.32 APHIS action on petition.

§ 124.30 Filing, format, and content of (a) Within 90 days after APHIS re- petitions. ceives a petition filed under § 124.30, the Under Secretary for Marketing and (a) Any interested person may file a Regulatory Programs shall make a de- petition with APHIS, no later than 180 termination under paragraphs (b) or (c) days after the publication of a regu- of this section or under § 124.33 whether latory review period determination the applicant acted with due diligence under § 124.21, alleging that a license during the regulatory review period. applicant did not act with due dili- APHIS will publish its determination gence in seeking APHIS approval of the in the FEDERAL REGISTER together with product during the regulatory review factual and legal basis for the deter- period. mination, notify PTO of the determina- (b) The petition must be filed with tion in writing, and send copies of the APHIS under the docket number of the determination to PTO, the applicant, FEDERAL REGISTER notice of the agen- and the petitioner. cy’s regulatory review period deter- (b) APHIS may deny a due diligence mination. The petition must contain petition without considering the mer- any additional information required by its of the petition if: this subpart. (1) The petition is not filed in accord- (c) The petition must allege that the ance with § 124.30; applicant failed to act with due dili- (2) The petition does not contain in- gence sometime during the regulatory formation or allegations upon which review period and must set forth suffi- APHIS may reasonably determine that cient facts to merit an investigation by the applicant did not act with due dili- APHIS of whether the applicant acted gence during the applicable regulatory with due diligence. review period; or (d) The petition must contain a cer- (3) The petition fails to allege a suffi- tification that the petitioner has cient total amount of time during served a true and complete copy of the which the applicant did not exercise petition on interested parties by cer- due diligence so that, even if the peti- tified or registered mail (return receipt tion were granted, the petition would requested) or by personal delivery. not affect the maximum patent term

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extension which the applicant is enti- (6) Contain a certification that the tled to under 35 U.S.C. 156. person requesting the hearing has served a true and complete copy of the [59 FR 11369, Feb. 25, 1993, as amended at 64 FR 43045, Aug. 9, 1999] request upon the petitioner of the due diligence determination and the appli- § 124.33 Standard of due diligence. cant for patent term extension by certified or registered mail (return receipt (a) In determining the due diligence requested) or by personal service. of an applicant, APHIS will examine the facts and circumstances of the ap- (c) The request must state whether plicant’s actions during the regulatory the requesting party seeks a hearing review period to determine whether the not later than 30 days after the date applicant exhibited the degree of atten- APHIS receives the request, or, at the tion, continuous directed effort, and request of the person making the re- timeliness as may reasonably be ex- quest, not later than 60 days after such pected from, and are ordinarily exer- date. cised by, a person during a regulatory [58 FR 11369, Feb. 25, 1993, as amended at 59 review period. APHIS will take into FR 67617, Dec. 30, 1994; 64 FR 43045, Aug. 9, consideration all relevant factors, such 1999; 75 FR 20773, Apr. 21, 2010] as the amount of time between the approval of an experimental use permit § 124.41 Notice of hearing. and licensure of the veterinary biologi- No later than ten days before the cal product. hearing, APHIS will notify the request- (b) For purposes of this Part, the ac- ing party, the applicant, the petitioner, tions of the marketing applicant shall and any other interested person of the be imputed to the applicant for patent date, time, and location of the hearing. term restoration. The actions of an agent, attorney, contractor, employee, § 124.42 Hearing procedure. licensee, or predecessor in interest of (a) The presiding officer shall be ap- the marketing applicant shall be im- pointed by the Administrator of APHIS puted to the applicant for patent term from officers and employees of the De- restoration. partment who have not participated in any action of the Secretary which is Subpart E—Due Diligence Hearing the subject of the hearing and who are not directly responsible to an officer or § 124.40 Request for hearing. employee of the Department who has (a) Any interested person may re- participated in any such action. quest, within 60 days beginning on the (b) Each party to the hearing shall date of publication of a due diligence have the right at all times to be ad- determination by APHIS in accordance vised and accompanied by an attorney. with § 124.32, that APHIS conduct an in- (c) Before the hearing, each party to formal hearing on the due diligence de- the hearing shall be given reasonable termination. notice of the matters to be considered (b) The request for a hearing must: at the hearing, including a comprehen- (1) Be in writing; sive statement of the basis for the ac- (2) Contain the docket number of the tion taken or proposed by the Sec- FEDERAL REGISTER notice of APHIS’s retary which is the subject of the hear- regulatory review period determina- ing and any general summary of the in- tion; formation which will be presented at (3) Be delivered to the Director, Cen- the hearing in support of such action. ter for Veterinary Biologics, Policy, (d) At the hearing the parties to the Evaluation, and Licensing, 1920 Dayton hearing shall have the right to hear a Avenue, P.O. Box 844, Ames, IA 50010. full and complete statement of the ac- (4) Contain a full statement of facts tion which is the subject of the hearing upon which the request for hearing is together with the information and rea- based; sons supporting such action, to con- (5) Contain the name, the address, duct reasonable questioning, and to and the principal place of business of present any oral and written informa- the person requesting the hearing; and tion relevant to such action.

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(e) The presiding officer in such hear- due diligence set forth in § 124.33 will ing shall prepare a written report of apply at the hearing. The party re- the hearing to which shall be attached questing the due diligence hearing will all written material presented at the have the burden of proof at the hear- hearing. The participants in the hearing. ing shall be given the opportunity to review and correct or supplement the § 124.43 Administrative decision. presiding officer’s report of the hear- Within 30 days after completion of ing. the due diligence hearing, the Under (f) The Secretary may require the Secretary for Marketing and Regu- hearing to be transcribed. A party to latory Programs, taking into consider- the hearing shall have the right to ation the recommendation of the Ad- have the hearing transcribed at his ex- ministrator, will affirm or revise the pense. Any transcription of a hearing determination made under § 124.32. shall be included in the presiding offi- APHIS will publish the due diligence cer’s report of the hearing. (g) The due diligence hearing will be redetermination in the FEDERAL REG- conducted in accordance with rules of ISTER, notify PTO of the redetermina- practice adopted for the proceeding. tion, and send copies of the notice to APHIS will provide the requesting PTO and the requesting party, the ap- party, the applicant, and the petitioner plicant, and the petitioner. with an opportunity to participate as a [59 FR 11369, Feb. 25, 1993, as amended at 64 party in the hearing. The standard of FR 43045, Aug. 9, 1999]

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PART 130—USER FEES 3701, 3716, 3717, 3719, and 3720A; 7 CFR 2.22, 2.80, and 371.4. Sec. SOURCE: 57 FR 771, Jan. 9, 1992, unless oth- 130.1 Definitions. erwise noted. 130.2 User fees for individual animals and certain birds quarantined in the APHIS- § 130.1 Definitions. owned or -operated quarantine facilities, As used in this part, the following including APHIS Animal Import Centers. terms shall have the meaning set forth 130.3 User fees for exclusive use of space at in this section. APHIS Animal Import Centers. 130.4 User fees for processing import permit Administrator. The Administrator of applications. the Animal and Plant Health Inspec- 130.5 User fees for services at privately tion Service, or any person authorized owned permanent and temporary import to act for the Administrator. quarantine facilities. Animal. All animals except birds, but 130.6 User fees for inspection of live animals including poultry. at land border ports along the United Animal and Plant Health Inspection States-Mexico border. Service (APHIS). The Animal and Plant 130.7 User fees for import or entry services for live animals at land border ports Health Inspection Service of the United along the United States-Canada border. States Department of Agriculture. 130.8 User fees for other services. Animal Import Center. Quarantine fa- 130.9 [Reserved] cilities operated by APHIS in New- 130.10 User fees for pet birds. burgh, New York, and Miami, Florida. 1 130.11 User fees for inspecting and approv- APHIS representative. An individual, ing import/export facilities and estab- including, but not limited to, an ani- lishments. mal health technician or veterinarian, 130.12–130.13 [Reserved] authorized by the Administrator to 130.14 User fees for FADDL veterinary diagnostics. perform the services for which the user 130.15 User fees for veterinary diagnostic fees in this part are charged. isolation and identification tests per- Approved establishment. An establish- formed at NVSL (excluding FADDL) or ment approved by the Animal and other authorized site. Plant Health Inspection Service for the 130.16 User fees for veterinary diagnostic se- receipt and handling of restricted im- rology tests performed at NVSL (exclud- port animal products or byproducts ing FADDL) or at authorized sites. under 9 CFR chapter I, subchapter D. 130.17 User fees for other veterinary diag- Biosecurity level three laboratory. A nostic laboratory tests performed at NVSL (excluding FADDL) or at author- laboratory or production facility that ized sites. works with foreign or domestic animal 130.18 User fees for veterinary diagnostic re- disease agents, organisms, or vectors agents produced at NVSL or other au- that spread by aerosol route and that thorized site (excluding FADDL). have serious or lethal effects, therefore 130.19 User fees for other veterinary diag- requiring special biocontainment nostic services or materials provided at measures. NVSL (excluding FADDL). Bird. Any member of the class aves, 130.20 User fees for endorsing export certificates. other than poultry. 130.21 [Reserved] Breeding animal. Any animal im- 130.22 User fees for inspection services out- ported into the United States for side the United States. breeding purposes. 130.23–130.29 [Reserved] Diagnostic reagent. Substances used in 130.30 Hourly rate and minimum user fees. diagnostic tests to detect disease 130.31–130.48 [Reserved] 130.49 Exemptions. 1 The addresses of Animal Import Centers 130.50 Payment of user fees. may be obtained from the Animal and Plant 130.51 Penalties for nonpayment or late Health Inspection Service, Veterinary Serv- payment. ices, National Center for Import-Export, 4700 AUTHORITY: 5 U.S.C. 5542; 7 U.S.C. 1622 and River Road, Unit 38, Riverdale, Maryland 8301–8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 20737–1231.

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agents or antibodies by causing an National Veterinary Services Labora- identifiable reaction. tories, Foreign Animal Disease Diagnostic Domestic animal. Any animal im- Laboratory (FADDL). The National Vet- ported into the United States for any erinary Services Laboratories, Foreign purpose other than exhibition in a zoo, Animal Disease Diagnostic Laboratory, park or other place maintained for the located in Greenport, New York. exhibition of live animals for rec- Nonstandard care and handling. Non- reational or educational purposes. standard care and handling includes Equine. Any horse, ass, mule, or hand-feeding, more than one feeding zebra. per day, frequent observation, and any Export health certificate. An official handling or observation that requires document that, as required by the im- personnel to attend to the birds or porting country, is endorsed by an poultry outside of normal business APHIS representative and states that hours. 2 animals, animal products, organisms, Nonstandard housing. Nonstandard vectors, or birds to be exported from housing is individual housing not nor- the United States were found to be mally available at an APHIS animal healthy and free from evidence of com- import center, any housing constructed municable diseases and pests. or purchased at the request of the im- Feeder animal. Any animal imported porter, any housing with blinds, dense into the United States under 9 CFR foliage, or plants, and any housing part 93 for feeding. where the temperature can be adjusted. Person. An individual, corporation, Game cock. Any chicken bred, partnership, trust, association, or any trained, or imported for cock fighting. other public or private entity, or any Germ plasm. Semen, embryos, or ova. officer, employee, or agent thereof. Grade animal. Any unregistered ani- Pet birds. Birds, except hatching eggs mal. and ratites, that are imported or ex- Import compliance assistance. Import ported for the personal pleasure of compliance assistance includes services their individual owners and are not in- provided to an importer whose ship- tended for resale. ment arrives at a port of entry without Poultry. Chickens, doves, ducks, the necessary paperwork or with in- geese, grouse, guinea fowl, partridges, complete paperwork and who requires pea fowl, pheasants, pigeons, quail, assistance to meet the requirements swans, and turkeys. for entry into the United States. Fees Privately operated permanent import- for import compliance assistance are quarantine facility. Any permanent fa- charged in addition to the flat rate cility approved under 9 CFR part 93 to user fees. quarantine animals or birds, except fa- In-bond animal. Any animal imported cilities operated by APHIS. into the United States under a United Registered animal. Any animal re- States Customs Service bond, as de- corded in the book of record of an ani- scribed in 19 CFR part 113. mal registry association which issues Load. Those animals, birds, or animal certificates concerning the pedigree of germ plasm, presented for importation animals. into the United States in a single ship- Slaughter animal. Any animal moving ment, that originate from one address, directly to slaughter. are destined for one address, and re- Standard feed. Seed, or dry feeds such quire one entry permit or authoriza- as dog food or monkey biscuits, wheth- tion. er soaked in water or not. Miniature horse. Any horse which at State animal health official. The State maturity measures 34 inches high or official responsible for livestock and less from the ground to the base of the poultry disease control and eradication last hair of the mane at the withers. programs. National Veterinary Services Labora- tories (NVSL). The National Veterinary 2 Normal business hours at the APHIS Ani- Services Laboratories of the Animal mal Import Centers are: 7 a.m. to 3:30 p.m., and Plant Health Inspection Service, Miami, FL; and 8 a.m. to 4:30 p.m., New- located in Ames, Iowa. burgh, NY.

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Test. A single analysis performed on a animals for recreational or educational single specimen from an animal, ani- purposes. mal product, commercial product, or [57 FR 771, Jan. 9, 1992, as amended at 58 FR animal feed. 38957, July 21, 1993; 58 FR 67654, Dec. 22, 1993; United States. The several States of 59 FR 67617, Dec. 30, 1994; 61 FR 20432, May 7, the United States, the District of Co- 1996; 62 FR 56026, Oct. 28, 1997; 63 FR 53788, lumbia, Guam, the Commonwealth of Oct. 7, 1998; 63 FR 64175, Nov. 19, 1998; 64 FR the Northern Mariana Islands, the 67698, Dec. 3, 1999; 65 FR 38178, 38180, June 20, 2000; 68 FR 64507, Nov. 14, 2003; 74 FR 14001, Commonwealth of Puerto Rico, the Mar. 30, 2009] Virgin Islands of the United States, and all other territories and posses- § 130.2 User fees for individual ani- sions of the United States. mals and certain birds quarantined Zoo animal. Any animal, including in the APHIS-owned or -operated quarantine facilities, including poultry, intended for exhibition in a APHIS Animal Import Centers. zoo, park or other place maintained for the exhibition of live animals for rec- (a) Standard requirements. User fees for any service rendered by an APHIS reational or educational purposes. 3 representative for each animal or bird Zoo bird. Any bird intended for exhi- receiving standard housing, care, feed, bition in a zoo, park or other place and handling while quarantined in an maintained for the exhibition of live APHIS owned or operated animal im- animals or birds for recreational or port center or quarantine facility are educational purposes. listed in the following table. Each user Zoo equine. Any equine intended for fee listed in the table is assessed per exhibition in a zoo, park or other place animal or bird quarantined by APHIS. maintained for the exhibition of live The person for whom the service is provided and the person requesting the service are jointly and severally liable for payment of these user fees in accordance with §§ 130.50 and 130.51.

Daily user fee Animal or bird Apr. 29, Oct. 1, 2009– Oct. 1, 2010– Oct. 1, 2011– 2009–Sept. Sept. 30, Sept. 30, Sept. 30, Beginning 30, 2009 2010 2011 2012 Oct. 1, 2012

Birds (excluding ratites and pet birds imported in accordance with part 93 of this subchapter): 0–250 grams...... $2.50 $2.75 $2.75 $2.75 $3.00 251–1,000 grams...... 8.25 8.50 8.75 9.00 9.25 Over 1,000 grams ...... 18.00 19.00 19.00 20.00 21.00 Domestic or zoo animals (except equines, birds, and poultry): Bison, bulls, camels, cattle, or zoo animals ...... 144.00 149.00 153.00 158.00 162.00 All others, including, but not limited to, alpacas, llamas, goats, sheep, and swine ...... 38.00 39.00 40.00 42.00 43.00 Equines (including zoo equines, but excluding miniature horses): 1st through 3rd day (fee per day) ...... 382.00 393.00 405.00 417.00 429.00 4th through 7th day (fee per day) ...... 276.00 284.00 292.00 301.00 310.00 8th and subsequent days (fee per day) 235.00 242.00 249.00 256.00 264.00 Miniature horses...... 86.00 89.00 91.00 94.00 97.00 Poultry (including zoo poultry): Doves, pigeons, quail...... 5.00 5.25 5.50 5.50 5.75 Chickens, ducks, grouse, guinea fowl, partridge, pea fowl, pheasants ...... 9.00 9.25 9.50 9.75 10.00

3 Regulations concerning approval of zoos and requirements for importing wild animals are found in part 93 of this chapter. 849

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Daily user fee Animal or bird Apr. 29, Oct. 1, 2009– Oct. 1, 2010– Oct. 1, 2011– 2009–Sept. Sept. 30, Sept. 30, Sept. 30, Beginning 30, 2009 2010 2011 2012 Oct. 1, 2012

Large poultry and large waterfowl, including, but not limited to, gamecocks, geese, swans, and turkeys .... 21.00 22.00 22.00 23.00 24.00 Ratites: Chicks (less than 3 months old) ...... 13.00 13.00 14.00 14.00 15.00 Juveniles (3 months through 10 months old)...... 20.00 20.00 21.00 22.00 22.00 Adults (11 months old or older) ...... 38.00 39.00 40.00 42.00 43.00

(b) Special requirements. User fees for requested by the importer or required birds or poultry, including zoo birds or by an APHIS representative. Certain poultry, receiving nonstandard hous- conditions or traits, such as pregnancy ing, care, or handling to meet special or aggression, may necessitate special requirements while quarantined in an requirements for certain birds or poul- APHIS owned or operated Animal Im- try. The person for whom the service is port Center or quarantine facility are provided and the person requesting the listed in the following table. The user service are jointly and severally liable fees listed in the table are assessed for for payment of these user fees in ac- each bird or poultry quarantined by cordance with §§ 130.50 and 130.51. APHIS. Special requirements may be

Daily user fee Bird or poultry (nonstandard housing, care, or Apr. 29, Oct. 1, 2009– Oct. 1, 2010– Oct. 1, 2011– handling) 2009–Sept. Sept. 30, Sept. 30, Sept. 30, Beginning 30, 2009 2010 2011 2012 Oct. 1, 2012

Birds 0–250 grams and doves, pigeons and quail ...... $8.25 $8.50 $8.75 $9.00 $9.25 Birds 251–1,000 grams and poultry such as chickens, ducks, grouse, guinea fowl, partridge, pea fowl, and pheasants ...... 18.00 19.00 19.00 20.00 21.00 Birds over 1,000 grams and large poultry and large waterfowl, including, but not limited to gamecocks, geese, swans, and turkeys ...... 35.00 36.00 37.00 39.00 40.00

(c) Feed. The importer must either § 130.3 User fees for exclusive use of provide feed or pay for it on an actual space at APHIS Animal Import Cen- cost basis, including the cost of deliv- ters. ery to the APHIS owned or operated (a)(1) An importer may request to ex- Animal Import Center or quarantine clusively occupy a space at an APHIS facility, for any animal or bird that requires a diet other than standard feed, animal import center. The user fees for including but not limited to diets of spaces at APHIS animal import centers fruit, insects, nectar, or fish. are listed in the following table. The person for whom the service is provided (Approved by the Office of Management and and the person requesting the service Budget under control number 0579–0094) are jointly and severally liable for pay- [63 FR 53788, Oct. 7, 1998, as amended at 65 FR ment of these user fees in accordance 52005, Aug. 28, 2000; 68 FR 51883, Aug. 29, 2003; with §§ 130.50 and 130.51. 68 FR 62227, Nov. 3, 2003; 72 FR 70765, Dec. 13, 2007; 74 FR 14001, Mar. 30, 2009]

Monthly user fee Apr. 29, Animal import center 2009– Oct. 1, 2009– Oct. 1, 2010– Oct. 1, 2011– Beginning Sept. 30, Sept. 30, Sept. 30, Sept. 30, October 1, 2009 2010 2011 2012 2012

Newburgh, NY:

850

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Monthly user fee Apr. 29, Animal import center 2009– Oct. 1, 2009– Oct. 1, 2010– Oct. 1, 2011– Beginning Sept. 30, Sept. 30, Sept. 30, Sept. 30, October 1, 2009 2010 2011 2012 2012

Space A ...... 5,396 sq. ft...... (503.1 sq. m.) ...... $83,756.00 $86,268.00 $88,856.00 $91, 513.00 $94,249.00 Space B ...... 8,903 sq. ft...... (827.1 sq. m.) ...... 138,190.00 142,335.00 146,605.00 150,989.00 155,504.00 Space C ...... 905 sq. ft...... (84.1 sq. m.) ...... 14,047.00 14,469.00 14,903.00 15,348.00 15,807.00

(2) Any importer who occupies space porter, then the importer must pay for for more than 30 days must pay 1/30th additional services on an hourly basis, of the 30-day fee for each additional or reduce the number of animals or day or part of a day. The person for birds to be quarantined to a number whom the service is provided and the which APHIS personnel at the Animal person requesting the service are joint- Import Center determine can be han- ly and severally liable for any addi- dled by two animal health technicians. tional charges. (3) If the importer requests addi- (3) Unless the importer cancels the tional services, then the user fees for reservation for exclusive use of space in time to receive a refund of the res- any service rendered by an APHIS rep- ervation fee in accordance with 9 CFR resentative will be calculated at the 93.103, 93.204, 93.304, 93.404, or 93.504, as hourly rate user fee listed in § 130.30, appropriate, the 30-day user fee will be for each employee required to perform effective as of the first day for which the service. the importer has reserved the space, re- (d) The importer must provide feed, gardless of whether the user occupies or pay for it on an actual cost basis, in- the space on that date or not. cluding cost of delivery to the Animal (b) Users must provide APHIS per- Import Center. sonnel at the Animal Import Center, at the time they make a reservation for (Approved by the Office of Management and quarantine space, with the following Budget under control numbers 0579–0040 and 0579–0094) information: (1) Species of animals and birds to be [57 FR 771, Jan. 9, 1992, as amended at 58 FR quarantined; 67654, Dec. 22, 1993; 61 FR 20432, May 7, 1996; (2) Ages of animals and birds to be 62 FR 56026, Oct. 28, 1997; 63 FR 53789, Oct. 7, quarantined; and 1998; 65 FR 52006, Aug. 28, 2000; 68 FR 51883, (3) Sizes of animals and birds to be Aug. 29, 2003; 72 FR 70765, Dec. 13, 2007; 74 FR quarantined. 14002, Mar. 30, 2009; 74 FR 18115, Apr. 21, 2009] (c)(1) APHIS personnel at the Animal Importer Center will determine, based § 130.4 User fees for processing import on the information provided by the im- permit applications. porter under paragraph (b) of this sec- User fees for any service rendered by tion, and on routine husbandry needs, an APHIS representative for processing the maximum number of animals and applications for permits to import cer- birds permitted in the requested build- tain animals and animal products ing. (using VS forms 16–3 and 17–129) are (2) If the number of animals and birds listed in the table in this section. The requested by the importer can be person for whom the service is provided housed in the space requested, as deter- and the person requesting the service mined by APHIS personnel at the Ani- are jointly and severally liable for pay- mal Import Center, but two animal ment of these user fees in accordance health technicians cannot fulfill the with §§ 130.50 and 130.51. These fees are routine husbandry needs of the number nonrefundable. The table follows: of animals or birds proposed by the im-

851

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User fee Apr. 29, Service Unit 2009– Oct. 1, 2009– Oct. 1, 2010– Oct. 1, 2011– Beginning Sept. 30, Sept. 30, Sept. 30, Sept. 30, Oct. 1, 2012 2009 2010 2011 2012

Import compliance assistance: Simple (4 hours or less) .. Per shipment .. $99.00 $102.00 $105.00 $108.00 $111.00 Complicated (more than 4 Per shipment.. 514.00 514.00 531.00 548.00 565.00 hours). Processing an application for a permit to import live animals, animal products or by products, organisms, vectors, or germ plasm (embryos or semen) or to transport organisms or vectors1 Initial permit ...... Per application 133.00 137.00 141.00 145.00 150.00 Amended permit ...... Per amended 66.00 68.00 70.00 73.00 75.00 application. Renewed permit 2 ...... Per application 86.00 89.00 91.00 94.00 97.00 Processing an application for Per application 455.00 469.00 483.00 497.00 512.00 a permit to import fetal bovine serum when facility inspection is required. 1 Using Veterinary Services Form 16–3, ‘‘Application for Permit to Import or Transport Controlled Material or Organisms or Vectors,’’ or Form 17–129, ‘‘Application for Import or In Transit Permit (Animals, Animal Semen, Animal Embryos, Birds, Poultry, or Hatching Eggs).’’ 2 Permits to import germ plasm and live animals are not renewable.

[66 FR 39631, Aug. 1, 2001, as amended at 68 FR 51883, Aug. 29, 2003; 72 FR 70766, Dec. 13, 2007; 74 FR 14002, Mar. 30, 2009]

§ 130.5 User fees for services at pri- § 130.6 User fees for inspection of live vately owned permanent and tem- animals at land border ports along porary import quarantine facilities. the United States-Mexico border. (a) User fees for any service rendered (a) User fees for any service rendered by an APHIS representative for each by an APHIS representative for live animal quarantined in a privately oper- animals presented for importation into ated permanent or temporary import or entry into the United States quarantine facility will be calculated through a land border port along the at the hourly user fee rate listed in United States-Mexico border are listed § 130.30, for each employee required to in the following table. The minimum perform the service. The person for whom the service is provided and the user fee for this service is listed in person requesting the service are joint- § 130.30. The person for whom the serv- ly and severally liable for payment of ice is provided and the person request- these user fees in accordance with ing the service are jointly and sever- §§ 130.50 and 130.51. ally liable for payment of these user (b) [Reserved] fees in accordance with §§ 130.50 and 130.51. (Approved by the Office of Management and Budget under control number 0579–0094) [65 FR 52006, Aug. 28, 2000, as amended at 72 FR 70766, Dec. 13, 2007]

Per head user fee Type of live animal April 29, Oct. 1, 2009– Oct. 1, 2010– Oct. 1, 2011– 2009–Sept. Sept. 30, Sept. 30, Sept. 30, Beginning 30, 2009 2010 2011 2012 Oct. 1, 2012

Any ruminants (including breeder ruminants) not covered below...... $13.00 $13.00 $14.00 $14.00 $14.00 Feeder ...... 3.75 3.75 4.00 4.00 4.00 Horses, other than slaughter ...... 62.00 64.00 66.00 68.00 70.00 In-bond or in-transit...... 8.25 8.50 8.75 9.00 9.25

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Per head user fee Type of live animal April 29, Oct. 1, 2009– Oct. 1, 2010– Oct. 1, 2011– 2009–Sept. Sept. 30, Sept. 30, Sept. 30, Beginning 30, 2009 2010 2011 2012 Oct. 1, 2012

Slaughter ...... 5.50 5.50 5.75 6.00 6.00

(b) [Reserved] animals presented for importation into (Approved by the Office of Management and or entry into the United States Budget under control numbers 0579–0055 and through a land border port along the 0579–0094) United States-Canada border are listed [65 FR 52006, Aug. 28, 2000, as amended at 68 in the following table. The minimum FR 51884, Aug. 29, 2003; 72 FR 70766, Dec. 13, user fee for this service is listed in 2007; 74 FR 14003, Mar. 30, 2009] § 130.30. The person for whom the service is provided and the person request- § 130.7 User fees for import or entry ing the service are jointly and sever- services for live animals at land ally liable for payment of these user border ports along the United States-Canada border. fees in accordance with §§ 130.50 and 130.51. (a) User fees for any service rendered by an APHIS representative for live

User fee Type of live animal Unit Apr. 29, Oct. 1, 2009– Oct. 1, 2010– Oct. 1, 2011– 2009–Sept. Sept. 30, Sept. 30, Sept. 30, Beginning 30, 2009 2010 2011 2012 Oct. 1, 2012

Animals being imported into the United States: Breeding animals (Grade animals, except horses): Sheep and goats ...... Per head ...... $0.75 $0.75 $0.75 $1.00 $1.00 Swine ...... Per head...... 1.25 1.25 1.25 1.25 1.25 All others...... Per head...... 4.75 4.75 5.00 5.25 5.25 Feeder animals: Cattle (not including Per head...... 2.25 2.25 2.50 2.50 2.50 calves). Sheep and calves ...... Per head ...... 0.75 0.75 1.00 1.00 1.00 Swine ...... Per head...... 0.50 0.50 0.50 0.50 0.50 Horses (including reg- Per head...... 41.00 42.00 43.00 45.00 46.00 istered horses) other than slaughter and in- transit. Poultry (including eggs), Per load...... 71.00 73.00 75.00 77.00 80.00 imported for any purpose. Registered animals, all Per head...... 8.50 8.75 9.25 9.50 9.75 types (except horses). Slaughter animals, all Per load...... 35.00 36.00 37.00 39.00 40.00 types (except poultry). Animals transiting 1 the United States: Cattle ...... Per head...... 2.25 2.25 2.50 2.50 2.50 Sheep and goats ...... Per head ...... 0.50 0.50 0.50 0.50 0.50 Swine ...... Per head...... 0.50 0.50 0.50 0.50 0.50 Horses and all other ani- Per head ...... 9.75 10.00 10.00 10.00 11.00 mals. 1 The user fee in this section will be charged for in-transit authorizations at the port where the authorization services are performed. For additional services provided by APHIS, at any port, the hourly user fee in § 130.30 will apply.

(b) If a service must be conducted on chapter, must be paid for each service, a Sunday or holiday or at any other time outside the normal tour of duty of the employee, then reimbursable overtime, as provided for in part 97 of this

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in addition to the user fee listed in this § 130.8 User fees for other services. section. (a) User fees for any service rendered (Approved by the Office of Management and by an APHIS representative for other Budget under control numbers 0579–0055 and services that are not specifically ad- 0579–0094) dressed elsewhere in part 130 are listed in the following table. The person for [65 FR 52007, Aug. 28, 2000, as amended at 67 FR 48524, July 25, 2002; 68 FR 51884, Aug. 29, whom the service is provided and the 2003; 72 FR 70766, Dec. 13, 2007; 74 FR 14003, person requesting the service are joint- Mar. 30, 2009] ly and severally liable for payment of these user fees in accordance with §§ 130.50 and 130.51.

User fee Service Unit Apr. 29, Oct. 1, 2009– Oct. 1, 2010– Oct. 1, 2011– 2009–Sept. Sept. 30, Sept. 30, Sept. 30, Beginning 30, 2009 2010 2011 2012 Oct. 1, 2012

Germ plasm being exported: 1 Embryo: Up to 5 donor pairs ...... Per certificate $117.00 $121.00 $124.00 $128.00 $132.00 Each additional group of Per group of 52.00 54.00 55.00 57.00 59.00 donor pairs, up to 5 donor pairs. pairs per group on the same certificate. Semen ...... Per certificate 72.00 74.00 76.00 79.00 81.00 Release from export agricultural hold: Simple (2 hours or less) .. Per release ..... 99.00 102.00 105.00 108.00 111.00 Complicated (more than 2 Per release..... 254.00 262.00 270.00 278.00 286.00 hours). 1 This user fee includes a single inspection and resealing of the container at the APHIS employee’s regular tour of duty station or at a limited port. For each subsequent inspection and resealing required, the hourly user fee in § 130.3 will apply.

(b) [Reserved] § 130.9 [Reserved] (Approved by the Office of Management and Budget under control numbers 0579–0015, § 130.10 User fees for pet birds. 0579–0040, 0579–0055 and 0579–0094) (a) User fees for pet birds of U.S. ori- [65 FR 52007, Aug. 28, 2000, as amended at 66 gin returning to the United States, ex- FR 39632, Aug. 1, 2001; 68 FR 51884, Aug. 29, cept pet birds of U.S. origin returning 2003; 72 FR 70766, Dec. 13, 2007; 74 FR 14004, from Canada, are as follows: Mar. 30, 2009]

Per lot user fee Service Apr. 29, Oct. 1, 2009– Oct. 1, 2010– Oct. 1, 2011– 2009–Sept. Sept. 30, Sept. 30, Sept. 30, Beginning 30, 2009 2010 2011 2012 Oct. 1, 2012

(1) Which have been out of the United States 60 days or less ...... $153.00 $157.00 $162.00 $167.00 $172.00 (2) Which have been out of the United States more than 60 days ...... 363.00 374.00 385.00 397.00 409.00

(b) User fees for each pet bird quar- person for whom the service is provided antined in an animal import center or and the person requesting the service other APHIS-owned or supervised quar- are jointly and severally liable for pay- antine facility are listed in the fol- ment of these user fees in accordance lowing table. These user fees include with §§ 130.50 and 130.51. standard care, feed, and handling. The

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Daily user fee Number of birds in isolette Apr. 29, Oct. 1, 2009– Oct. 1, 2010– Oct. 1, 2011– 2009–Sept. Sept. 30, Sept. 30, Sept. 30, Beginning 30, 2009 2010 2011 2012 Oct. 1, 2012

1 ...... $13.00 $13.00 $14.00 $14.00 $15.00 2 ...... 16.00 16.00 17.00 17.00 18.00 3 ...... 18.00 19.00 19.00 20.00 21.00 4 ...... 21.00 22.00 22.00 23.00 24.00 5 or more ...... 25.00 26.00 27.00 28.00 29.00

(c) Based on the information provided § 130.11 User fees for inspecting and to APHIS personnel, APHIS personnel approving import/export facilities at the Animal Import Center or other and establishments. APHIS owned or supervised quarantine (a) User fees for the inspection of var- facility will determine the appropriate ious import and export facilities and number of birds that should be housed per isolette. establishments are listed in the fol- (d) If the importer requests addi- lowing table. The person for whom the tional services, then the user fees for service is provided and the person re- those services will be calculated at the questing the service are jointly and hourly rate user fee listed in § 130.30, severally liable for payment of these for each employee required to perform user fees in accordance with §§ 130.50 the service. and 130.51. These user fees do not apply to inspection activities covered in (Approved by the Office of Management and Budget under control number 0579–0094) § 130.30(a)(2). [61 FR 20434, May 7, 1996; 61 FR 25513, May 21, 1996, as amended at 62 FR 56026, Oct. 28, 1997; 63 FR 53791, Oct. 7, 1998; 64 FR 67700, Dec. 3, 1999; 65 FR 52008, Aug. 28, 2000; 68 FR 51885, Aug. 29, 2003; 74 FR 14004, Mar. 30, 2009]

User fee Service Unit Apr. 29, Oct. 1, 2009– Oct. 1, 2010– Oct. 1, 2011– 2009–Sept. Sept. 30, Sept. 30, Sept. 30, Beginning 30, 2009 2010 2011 2012 Oct. 1, 2012

Embryo collection center in- Per year...... $537.00 $553.00 $570.00 $587.00 $604.00 spection and approval (all inspections required during the year for facility approval). Inspection for approval of bio- Per inspection 1,381.00 1,422.00 1,465.00 1,509.00 1,554.00 security level three labs (all inspections related to approving the laboratory for handling one defined set of organisms or vectors)1. Inspection for approval of slaughter establishment: Initial approval (all inspec- Per year...... 527.00 543.00 559.00 576.00 593.00 tions). Renewal (all inspections) Per year ...... 457.00 470.00 484.00 499.00 514.00 Inspection of approved establishments, warehouses, and facilities under 9 CFR parts 94 through 96: Approval (compliance Per year...... 563.00 579.00 597.00 615.00 633.00 agreement) (all inspections for first year of 3- year approval). Renewal (all inspections Per year...... 325.00 335.00 345.00 355.00 366.00 for second and third years of 3-year approval). 1 The hourly user fee rate in § 130.30(2) applies to biosecurity level two laboratories.

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(b) [Reserved] FADDL are listed in the following [65 FR 52008, Aug. 28, 2000, as amended at 68 table. The person for whom the service FR 51885, Aug. 29, 2003; 68 FR 64507, Nov. 14, is provided and the person requesting 2003; 72 FR 70766, Dec. 13, 2007; 74 FR 14004, the service are jointly and severally Mar. 30, 2009] liable for payment of these user fees in accordance with §§ 130.50 and 130.51. §§ 130.12–130.13 [Reserved] § 130.14 User fees for FADDL veterinary diagnostics. (a) Diagnostic reagents. User fees for diagnostic reagents 4 provided by

User fee Reagent Unit June 7, 2004– Oct. 1, 2004– Oct. 1, 2005– Beginning Sept. 30, 2004 Sept. 30, 2005 Sept. 30, 2006 Oct. 1, 2006

Bovine antiserum, any agent ...... 1 mL ...... $150.00 $155.00 $160.00 $165.00 Caprine antiserum, any agent ...... 1 mL ...... 184.00 189.00 195.00 202.00 Cell culture antigen/microorganism ...... 1 mL ...... 103.00 106.00 109.00 111.00 Equine antiserum, any agent ...... 1 mL ...... 186.00 192.00 198.00 204.00 Fluorescent antibody conjugate ...... 1 mL ...... 169.00 172.00 176.00 179.00 Guinea pig antiserum, any agent ...... 1 mL ...... 184.00 189.00 194.00 200.00 Monoclonal antibody ...... 1 mL ...... 222.00 229.00 235.00 243.00 Ovine antiserum, any agent ...... 1 mL ...... 176.00 181.00 187.00 193.00 Porcine antiserum, any agent ...... 1 mL ...... 152.00 157.00 162.00 167.00 Rabbit antiserum, any agent ...... 1 mL ...... 179.00 185.00 190.00 196.00

(b) Veterinary diagnostics tests. User questing the service are jointly and fees for veterinary diagnostic tests per- severally liable for payment of these formed at FADDL are listed in the fol- user fees in accordance with §§ 130.50 lowing table. The person for whom the and 130.51. service is provided and the person re-

User fee Test Unit June 7, 2004– Oct. 1, 2004– Oct. 1, 2005– Beginning Sept. 30, 2004 Sept. 30, 2005 Sept. 30, 2006 Oct. 1, 2006

Agar gel immunodiffusion ...... Test ...... $30.00 $31.00 $32.00 $33.00 Card ...... Test ...... 17.00 17.00 18.00 18.00 Complement fixation ...... Test ...... 36.00 37.00 38.00 40.00 Direct immunofluorescent antibody ...... Test ...... 22.00 23.00 24.00 25.00 Enzyme linked immunosorbent assay ... Test ...... 26.00 27.00 28.00 29.00 Fluorescent antibody neutralization Test ...... 194.00 201.00 208.00 215.00 (classical swine fever). Hemagglutination inhibition...... Test ...... 57.00 59.00 61.00 63.00 Immunoperoxidase ...... Test ...... 29.00 30.00 31.00 32.00 Indirect fluorescent antibody ...... Test ...... 35.00 36.00 37.00 39.00 In-vitro safety ...... Test ...... 570.00 589.00 609.00 630.00 In-vivo safety ...... Test ...... 5,329.00 5,387.00 5,447.00 5,509.00 Latex agglutination ...... Test ...... 23.00 24.00 25.00 26.00 Tube agglutination ...... Test ...... 28.00 28.00 29.00 30.00 Virus isolation (oesophageal/pharyn- Test ...... 180.00 186.00 192.00 199.00 geal). Virus isolation in embryonated eggs ...... Test ...... 346.00 358.00 370.00 383.00 Virus isolation, other ...... Test ...... 155.00 160.00 166.00 171.00 Virus neutralization...... Test ...... 52.00 54.00 56.00 58.00

4 Reagents provided by FADDL are for the the cost for the safety test in addition to the diagnosis of animal diseases foreign to the reagent user fee. For more information on United States. These reagents may be avail- the specific reagents contact: Laboratory able to customers on the mainland after Chief, USDA, APHIS, VS, FADDL, safety testing with permission from the Ad- Greenport, NY 11344; phone (516) 323–2500, ministrator. The customer may have to pay FAX (516) 323–2798.

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(c) Other veterinary diagnostic services. and the person requesting the service User fees for other veterinary diag- are jointly and severally liable for pay- nostic services performed at FADDL ment of these user fees in accordance are listed in the following table. The with §§ 130.50 and 130.51. person for whom the service is provided

User fee Veterinary diagnostic service Unit June 7, 2004– Oct. 1, 2004– Oct. 1, 2005– Beginning Sept. 30, 2004 Sept. 30, 2005 Sept. 30, 2006 Oct. 1, 2006

Bacterial isolation...... Test ...... $112.00 $115.00 $119.00 $123.00 Hourly user fee services 1 ...... Hour ...... 445.00 460.00 476.00 492.00 Hourly user fee services—Quarter hour Quarter hour ..... 111.00 115.00 119.00 123.00 Infected cells on chamber slides or Slide ...... 49.00 50.00 51.00 53.00 plates. Reference animal tissues for Set ...... 171.00 177.00 182.00 187.00 immunohistochemistry. Sterilization by gamma radiation ...... Can ...... 1,740.00 1,799.00 1,860.00 1,923.00 Training (school or technical assistance) Per person per 910.00 941.00 973.00 1,006.00 day. Virus titration ...... Test ...... 112.00 115.00 119.00 123.00 1 For all veterinary diagnostic services for which there is no flat rate user fee, the hourly rate user fee will be calculated for the actual time required to provide the service.

(Approved by the Office of Management and Budget under control numbers 0579–0055 and 0579– 0094) [63 FR 53791, Oct. 7, 1998, as amended at 64 FR 67700, Dec. 3, 1999; 68 FR 16940, Apr. 7, 2003; 69 FR 25307, May 6, 2004]

§ 130.15 User fees for veterinary diag- other authorized sites are listed in the nostic isolation and identification following table. The person for whom tests performed at NVSL (excluding the service is provided and the person FADDL) or other authorized site. requesting the service are jointly and (a) Bacteriology isolation and identi- severally liable for payment of these fication tests. User fees for bacteriology user fees in accordance with §§ 130.50 isolation and identification tests per- and 130.51. formed at NVSL (excluding FADDL) or

User fee Test Unit Jan. 18, Oct. 1, Oct. 1, Oct. 1, 2008–Sept. 2008–Sept. 2009–Sept. 2010–Sept. Beginning 30, 2008 30, 2009 30, 2010 30, 2011 Oct. 1, 2011

Bacterial identification, automated Isolate ...... $53.00 $54.00 $55.00 $57.00 $58.00 Bacterial identification, non-auto- Isolate ...... 90.00 92.00 94.00 96.00 98.00 mated. Bacterial isolation...... Sample ...... 36.00 37.00 38.00 39.00 40.00 Bacterial serotyping, all other ...... Isolate ...... 55.00 56.00 56.00 57.00 58.00 Bacterial serotyping, Pasteurella Isolate ...... 18.00 19.00 19.00 19.00 20.00 multocida. Bacterial serotyping, Salmonella .. Isolate ...... 36.00 37.00 38.00 39.00 40.00 Bacterial toxin typing ...... Isolate ...... 120.00 123.00 126.00 128.00 131.00 Bacteriology requiring special Test ...... 92.00 94.00 96.00 98.00 101.00 characterization. DNA fingerprinting...... Test ...... 59.00 61.00 62.00 63.00 64.00 DNA probe...... Test ...... 83.00 85.00 86.00 88.00 89.00 Fluorescent antibody...... Test ...... 19.00 19.00 20.00 20.00 20.00 Mycobacterium identification (bio- Isolate ...... 115.00 117.00 120.00 122.00 125.00 chemical). Mycobacterium identification (gas Procedure ...... 96.00 99.00 101.00 103.00 105.00 chromatography). Mycobacterium isolation, animal Submission ...... 844.00 852.00 868.00 884.00 900.00 inoculations. Mycobacterium isolation, all other Submission ...... 151.00 154.00 158.00 161.00 165.00 Mycobacterium paratuberculosis Submission ...... 72.00 74.00 75.00 77.00 79.00 isolation. Phage typing, all other ...... Isolate ...... 42.00 43.00 44.00 45.00 46.00

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User fee Test Unit Jan. 18, Oct. 1, Oct. 1, Oct. 1, 2008–Sept. 2008–Sept. 2009–Sept. 2010–Sept. Beginning 30, 2008 30, 2009 30, 2010 30, 2011 Oct. 1, 2011

Phage typing, Salmonella Isolate ...... 24.00 24.00 25.00 25.00 26.00 enteritidis.

(b) Virology identification tests. User whom the service is provided and the fees for virology identification tests person requesting the service are joint- performed at NVSL (excluding FADDL) ly and severally liable for payment of or other authorized sites are listed in these user fees in accordance with the following table. The person for §§ 130.50 and 130.51.

User fee Test Unit Jan. 18, Oct. 1, Oct. 1, Oct. 1, 2008–Sept. 2008–Sept. 2009–Sept. 2010–Sept. Beginning 30, 2008 30, 2009 30, 2010 30, 2011 Oct. 1, 2011

Fluorescent antibody tissue sec- Test ...... $29.00 $30.00 $30.00 $31.00 $31.00 tion. Virus isolation...... Test ...... 48.00 49.00 50.00 51.00 52.00

(Approved by the Office of Management and Budget under control numbers 0579–0055 and 0579– 0094) [63 FR 53792, Oct. 7, 1998, as amended at 69 FR 25308, May 6, 2004; 72 FR 71746, Dec. 19, 2007]

§ 130.16 User fees for veterinary diag- other authorized sites are listed in the nostic serology tests performed at following table. The person for whom NVSL (excluding FADDL) or at au- the service is provided and the person thorized sites. requesting the service are jointly and (a) Bacteriology serology tests. User severally liable for payment of these fees for bacteriology serology tests per- user fees in accordance with §§ 130.50 formed at NVSL (excluding FADDL) or and 130.51.

User fee Test Unit Jan. 18, Oct. 1, Oct. 1, Oct. 1, 2008–Sept. 2008–Sept. 2009–Sept. 2010–Sept. Beginning 30, 2008 30, 2009 30, 2010 30, 2011 Oct. 1, 2011

Brucella ring (BRT) ...... Test ...... $36.00 $37.00 $38.00 $39.00 $40.00 Brucella ring, heat inactivated Test ...... 36.00 37.00 38.00 39.00 40.00 (HIRT). Brucella ring, serial (Serial BRT) Test ...... 54.00 56.00 57.00 58.00 59.00 Buffered acidified plate antigen Test ...... 7.00 7.25 7.50 7.50 8.00 presumptive. Card ...... Test ...... 4.00 4.00 4.25 4.25 4.50 Complement fixation...... Test ...... 16.00 17.00 17.00 18.00 18.00 Enzyme linked immunosorbent Test ...... 16.00 17.00 17.00 18.00 18.00 assay. Indirect fluorescent antibody ...... Test ...... 14.00 15.00 15.00 15.00 16.00 Microscopic agglutination—in- Sample ...... 24.00 24.00 25.00 25.00 26.00 cludes up to 5 serovars. Microscopic agglutination—each Sample ...... 4.25 4.50 4.50 4.50 4.75 serovar in excess of 5 serovars. Particle concentration fluorescent Test ...... 36.00 37.00 38.00 38.00 39.00 immunoassay (PCFIA). Plate ...... Test ...... 7.00 7.25 7.50 7.50 7.75 Rapid automated presumptive ..... Test ...... 7.00 7.00 7.25 7.25 7.25 Rivanol ...... Test ...... 7.00 7.25 7.50 7.50 7.75 Tube agglutination...... Test ...... 7.00 7.25 7.50 7.50 7.75

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(b) Virology serology tests. User fees service is provided and the person refor virology serology tests performed questing the service are jointly and at NVSL (excluding FADDL) or at au- severally liable for payment of these thorized sites are listed in the fol- user fees in accordance with §§ 130.50 lowing table. The person for whom the and 130.51.

User fee Test Unit Jan. 18, Oct. 1, Oct. 1, Oct. 1, 2008–Sept. 2008–Sept. 2009–Sept. 2010–Sept. Beginning 30, 2008 30, 2009 30, 2010 30, 2011 Oct. 1, 2011

Agar gel immunodiffusion ...... Test ...... $16.00 $17.00 $17.00 $17.00 $18.00 Complement fixation...... Test ...... 16.00 17.00 17.00 18.00 18.00 Enzyme linked immunosorbent Test ...... 16.00 17.00 17.00 18.00 18.00 assay. Hemagglutination inhibition...... Test ...... 14.00 15.00 15.00 15.00 16.00 Indirect fluorescent antibody ...... Test ...... 14.00 15.00 15.00 15.00 16.00 Latex agglutination...... Test ...... 16.00 17.00 17.00 17.00 18.00 Peroxidase linked antibody ...... Test ...... 15.00 16.00 16.00 16.00 17.00 Plaque reduction neutralization .... Test ...... 18.00 18.00 19.00 19.00 19.00 Rabies fluorescent antibody neu- Test ...... 45.00 46.00 47.00 49.00 50.00 tralization. Virus neutralization...... Test ...... 13.00 13.00 14.00 14.00 14.00

(Approved by the Office of Management and Budget under control numbers 0579–0055 and 0579– 0094) [63 FR 53793, Oct. 7, 1998, as amended at 69 FR 25309, May 6, 2004; 72 FR 71746, Dec. 19, 2007]

§ 130.17 User fees for other veterinary cluding FADDL) or at authorized sites diagnostic laboratory tests per- are listed in the following table. The formed at NVSL (excluding FADDL) person for whom the service is provided or at authorized sites. and the person requesting the service (a) User fees for veterinary are jointly and severally liable for pay- diagnostics tests performed at the ment of these user fees in accordance Pathobiology Laboratory at NVSL (ex- with §§ 130.50 and 130.51.

User fee Test Unit Jan. 18, Oct. 1, Oct. 1, Oct. 1, 2008–Sept. 2008–Sept. 2009–Sept. 2010–Sept. Beginning 30, 2008 30, 2009 30, 2010 30, 2011 Oct. 1, 2011

Aflatoxin quantitation...... Test ...... $30.00 $31.00 $32.00 $32.00 $33.00 Aflatoxin screen...... Test ...... 29.00 29.00 30.00 30.00 31.00 Agar gel immunodiffusion spp. Test ...... 13.00 13.00 13.00 14.00 14.00 identification. Antibiotic (bioautography) quan- Test ...... 66.00 67.00 68.00 70.00 72.00 titation. Antibiotic (bioautography) screen Test ...... 119.00 122.00 125.00 128.00 130.00 Antibiotic inhibition...... Test ...... 66.00 67.00 68.00 70.00 72.00 Arsenic ...... Test ...... 17.00 18.00 18.00 19.00 19.00 Ergot alkaloid screen ...... Test ...... 66.00 67.00 68.00 70.00 72.00 Ergot alkaloid confirmation ...... Test ...... 86.00 88.00 89.00 91.00 94.00 Feed microscopy...... Test ...... 66.00 67.00 68.00 70.00 72.00 Fumonisin only...... Test ...... 37.00 38.00 39.00 40.00 40.00 Gossypol ...... Test ...... 98.00 100.00 103.00 105.00 107.00 Mercury ...... Test ...... 145.00 148.00 151.00 155.00 158.00 Metals screen...... Test ...... 44.00 45.00 46.00 47.00 48.00 Metals single element confirma- Test ...... 13.00 13.00 13.00 14.00 14.00 tion. Mycotoxin: aflatoxin-liver...... Test ...... 119.00 122.00 125.00 128.00 130.00 Mycotoxin screen...... Test ...... 48.00 49.00 50.00 51.00 52.00 Nitrate/nitrite ...... Test ...... 66.00 67.00 68.00 70.00 72.00 Organic compound confirmation .. Test ...... 88.00 90.00 92.00 94.00 96.00 Organic compound screen ...... Test ...... 151.00 155.00 158.00 161.00 165.00 Parasitology ...... Test ...... 29.00 29.00 30.00 30.00 31.00 Pesticide quantitation...... Test ...... 132.00 135.00 138.00 141.00 144.00 Pesticide screen...... Test ...... 60.00 62.00 63.00 64.00 66.00 pH ...... Test ...... 26.00 27.00 28.00 28.00 29.00 Plate cylinder ...... Test ...... 98.00 100.00 103.00 105.00 107.00

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User fee Test Unit Jan. 18, Oct. 1, Oct. 1, Oct. 1, 2008–Sept. 2008–Sept. 2009–Sept. 2010–Sept. Beginning 30, 2008 30, 2009 30, 2010 30, 2011 Oct. 1, 2011

Selenium ...... Test ...... 44.00 45.00 46.00 47.00 48.00 Silicate/carbonate disinfectant...... Test ...... 66.00 67.00 68.00 70.00 72.00 Temperature disks...... Test ...... 130.00 133.00 136.00 139.00 142.00 Toxicant quantitation, other ...... Test ...... 110.00 112.00 115.00 117.00 120.00 Toxicant screen, other ...... Test ...... 33.00 33.00 34.00 35.00 36.00 Vomitoxin only...... Test ...... 53.00 54.00 55.00 56.00 58.00 Water activity...... Test ...... 33.00 33.00 34.00 35.00 36.00 Zearaleone quantitation...... Test ...... 53.00 54.00 55.00 56.00 58.00 Zearaleone screen...... Test ...... 29.00 29.00 30.00 30.00 31.00

(b) [Reserved] Diagnostic Bacteriology Laboratory at (Approved by the Office of Management and NVSL (excluding FADDL) or other au- Budget under control numbers 0579–0055 and thorized site are listed in the following 0579–0094) table. The person for whom the service [63 FR 53793, Oct. 7, 1998, as amended at 69 FR is provided and the person requesting 25309, May 6, 2004; 72 FR 71747, Dec. 19, 2007] the service are jointly and severally liable for payment of these user fees in § 130.18 User fees for veterinary diag- accordance with §§ 130.50 and 130.51. nostic reagents produced at NVSL or other authorized site (excluding FADDL). (a) Bacteriology reagents. User fees for bacteriology reagents produced by the

User fee Reagent Unit Jan. 18, Oct. 1, Oct. 1, Oct. 1, 2008–Sept. 2008–Sept. 2009–Sept. 2010–Sept. Beginning 30, 2008 30, 2009 30, 2010 30, 2011 Oct. 1, 2011

Anaplasma card test antigen ...... 2 mL ...... $95.00 $97.00 $99.00 $101.00 $103.00 Anaplasma card test kit without Kit ...... 127.00 130.00 133.00 136.00 139.00 antigen. Anaplasma CF antigen ...... 2 mL ...... 46.00 46.00 46.00 47.00 47.00 Anaplasma stabilate ...... 4.5 mL ...... 175.00 178.00 181.00 185.00 188.00 Avian origin bacterial antiserums 1 mL ...... 48.00 49.00 50.00 51.00 52.00 Bacterial agglutinating antigens 5 mL...... 54.00 55.00 57.00 58.00 59.00 other than brucella and salmonella pullorum. Bacterial conjugates ...... 1 mL ...... 96.00 99.00 101.00 103.00 105.00 Bacterial disease CF antigens, all 1 mL...... 29.00 30.00 30.00 31.00 32.00 other. Bacterial ELISA antigens ...... 1 mL ...... 29.00 30.00 31.00 31.00 32.00 Bacterial or protozoal antiserums, 1 mL...... 60.00 61.00 63.00 64.00 66.00 all other. Bacterial reagent culture 1 ...... Culture ...... 73.00 74.00 76.00 78.00 79.00 Bacterial reference culture 2 ...... Culture ...... 228.00 233.00 239.00 244.00 249.00 Bacteriophage reference culture .. Culture ...... 172.00 176.00 180.00 183.00 188.00 Bovine serum factor ...... 1 mL ...... 18.00 18.00 19.00 19.00 19.00 Brucella abortus CF antigen ...... 60 mL ...... 151.00 154.00 158.00 161.00 165.00 Brucella agglutination antigens, all 60 mL...... 151.00 154.00 158.00 161.00 165.00 other. Brucella buffered plate antigen .... 60 mL ...... 172.00 176.00 180.00 183.00 188.00 Brucella canis tube antigen ...... 25 mL ...... 114.00 116.00 119.00 121.00 124.00 Brucella card test antigen (pack- Package ...... 90.00 92.00 94.00 96.00 98.00 aged). Brucella card test kit without anti- Kit ...... 113.00 114.00 116.00 117.00 119.00 gen. Brucella cells...... Gram ...... 19.00 19.00 19.00 20.00 20.00 Brucella cells, dried...... Pellet ...... 6.00 6.00 6.25 6.25 6.25 Brucella ring test antigen ...... 60 mL ...... 241.00 246.00 252.00 257.00 263.00 Brucella rivanol solution ...... 60 mL ...... 29.00 30.00 31.00 31.00 32.00 Dourine CF antigen ...... 1 mL ...... 89.00 91.00 93.00 95.00 97.00 Dourine stabilate ...... 4.5 mL ...... 109.00 111.00 112.00 114.00 116.00

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User fee Reagent Unit Jan. 18, Oct. 1, Oct. 1, Oct. 1, 2008–Sept. 2008–Sept. 2009–Sept. 2010–Sept. Beginning 30, 2008 30, 2009 30, 2010 30, 2011 Oct. 1, 2011

Equine and bovine origin babesia 1 mL...... 127.00 130.00 133.00 136.00 139.00 species antiserums. Equine negative control CF anti- 1 mL...... 282.00 283.00 286.00 290.00 293.00 gen. Flazo-orange ...... 3 mL...... 13.00 13.00 13.00 13.00 14.00 Glanders CF antigen ...... 1 mL ...... 77.00 79.00 81.00 82.00 84.00 Hemoparasitic disease CF anti- 1 mL...... 541.00 553.00 565.00 577.00 590.00 gens, all other. Leptospira transport medium ...... 10 mL ...... 4.25 4.50 4.50 4.50 4.75 Monoclonal antibody ...... 1 mL ...... 95.00 97.00 99.00 101.00 103.00 Mycobacterium spp. old tuberculin 1 mL ...... 24.00 24.00 25.00 25.00 26.00 Mycobacterium spp. PPD ...... 1 mL ...... 18.00 19.00 19.00 19.00 20.00 Mycoplasma hemagglutination 5 mL...... 180.00 184.00 188.00 192.00 197.00 antigens. Negative control serums ...... 1 mL ...... 18.00 19.00 19.00 19.00 20.00 Rabbit origin bacterial antiserum 1 mL ...... 52.00 53.00 54.00 55.00 56.00 Salmonella pullorum microaggluti- 5 mL...... 15.00 16.00 16.00 16.00 17.00 nation antigen. Stabilates, all other ...... 4.5 mL ...... 684.00 690.00 703.00 716.00 730.00 1 A reagent culture is a bacterial culture that has been subcultured one or more times after being tested for purity and identity. It is intended for use as a reagent with a diagnostic test such as the leptospiral agglutination test. 2 A reference culture is a bacterial culture that has been thoroughly tested for purity and identity. It should be suitable as a master seed for future cultures.

(b) Virology reagents. User fees for vi- The person for whom the service is pro- rology reagents produced by the Diag- vided and the person requesting the nostic Virology Laboratory at NVSL service are jointly and severally liable (excluding FADDL) or at authorized for payment of these user fees in ac- sites are listed in the following table. cordance with §§ 130.50 and 130.51.

User fee Reagent Unit Jan. 18, Oct. 1, Oct. 1, Oct. 1, 2008–Sept. 2008–Sept. 2009–Sept. 2010–Sept. Beginning 30, 2008 30, 2009 30, 2010 30, 2011 Oct. 1, 2011

Antigen, except avian influenza 2 mL...... $61.00 $62.00 $64.00 $65.00 $67.00 and chlamydia psittaci antigens, any. Avian antiserum except avian in- 2 mL...... 48.00 49.00 51.00 52.00 53.00 fluenza antiserum, any. Avian influenza antigen, any ...... 2 mL ...... 33.00 34.00 35.00 36.00 36.00 Avian influenza antiserum, any .... 6 mL ...... 103.00 105.00 108.00 110.00 113.00 Bovine or ovine serum, any ...... 2 mL ...... 127.00 130.00 133.00 136.00 139.00 Cell culture...... Flask ...... 151.00 154.00 158.00 161.00 165.00 Chlamydia psittaci spp. of origin Panel ...... 95.00 96.00 98.00 99.00 101.00 monoclonal antibody panel. Conjugate, any ...... 1 mL ...... 73.00 75.00 76.00 78.00 80.00 Diluted positive control serum, 2 mL...... 24.00 25.00 25.00 26.00 27.00 any. Equine antiserum, any ...... 2 mL ...... 45.00 46.00 47.00 48.00 49.00 Monoclonal antibody ...... 1 mL ...... 102.00 104.00 106.00 108.00 110.00 Other spp. antiserum, any ...... 1 mL ...... 52.00 52.00 52.00 53.00 53.00 Porcine antiserum, any ...... 2 mL ...... 105.00 108.00 110.00 113.00 115.00 Porcine tissue sets ...... Tissue set ...... 157.00 157.00 158.00 159.00 161.00 Positive control tissues, all ...... 2 cm2 section ..... 60.00 62.00 63.00 65.00 66.00 Rabbit origin antiserum ...... 1 mL ...... 52.00 53.00 54.00 55.00 56.00 Reference virus, any ...... 0.6 mL ...... 180.00 184.00 188.00 193.00 197.00 Viruses (except reference vi- 0.6 mL...... 30.00 31.00 32.00 32.00 33.00 ruses), chlamydia psittaci agent or chlamydia psittaci antigen, any.

(Approved by the Office of Management and Budget under control number 0579–0094) [63 FR 53794, Oct. 7, 1998, as amended at 68 FR 16940, Apr. 7, 2003; 69 FR 25310, May 6, 2004; 72 FR 71748, Dec. 19, 2007]

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§ 130.19 User fees for other veterinary are listed in the following table. The diagnostic services or materials person for whom the service is provided provided at NVSL (excluding and the person requesting the service FADDL). are jointly and severally liable for pay- (a) User fees for other veterinary di- ment of these user fees in accordance agnostic services or materials avail- with §§ 130.50 and 130.51. able from NVSL (excluding FADDL)

User fee Service Unit Jan. 18, Oct. 1, Oct. 1, Oct. 1, 2008–Sept. 2008–Sept. 2009–Sept. 2010–Sept. Beginning 30, 2008 30, 2009 30, 2010 30, 2011 Oct. 1, 2011

Antimicrobial susceptibility test .... Isolate ...... $105.00 $107.00 $109.00 $112.00 $114.00 Avian safety test ...... Test ...... 4,082.00 4,090.00 4,099.00 4,109.00 4,180.00 Check tests, culture ...... Kit 1 ...... 176.00 179.00 182.00 185.00 189.00 Check tests, serology ...... Kit 1 ...... 361.00 369.00 377.00 385.00 394.00 Fetal bovine serum safety test ..... Verification ...... 1,119.00 1,122.00 1,134.00 1,147.00 1,160.00 Hourly user fees: 2 Hour ...... Hour ...... 104.00 104.00 108.00 112.00 112.00 Quarter hour ...... Quarter Hour ...... 26.00 26.00 27.00 28.00 28.00 Minimum ...... 30.00 ...... 31.00 32.00 33.00 33.00 Manual, brucellosis cul- 1 copy...... 115.00 117.00 120.00 122.00 125.00 ture. Manual, tuberculosis 1 copy...... 172.00 176.00 180.00 183.00 188.00 Culture (English or Spanish). Manual, Veterinary my- 1 copy...... 172.00 176.00 180.00 183.00 188.00 cology. Manuals or standard op- 1 copy...... 34.00 35.00 36.00 37.00 37.00 erating procedure (SOP), all other. Manuals or SOP, per 1 page...... 2.25 2.50 2.50 2.75 2.75 page. Training (school or tech- Per person per 332.00 339.00 346.00 354.00 362.00 nical assistance). day. 1 Any reagents required for the check test will be charged separately. 2 For veterinary diagnostic services for which there is no flat user fee the Hourly rate user fee will be calculated for the actual time required to provide the service.

(b) [Reserved] cinations are listed in the following table. The user fees apply to each ex- (Approved by the Office of Management and port health certificate 5 endorsed for Budget under control number 0579–0094) the following types of animals, birds, [63 FR 53795, Oct. 7, 1998, as amended at 69 FR or animal products, regardless of the 25311, May 6, 2004; 72 FR 71749, Dec. 19, 2007] number of animals, birds, or animal products covered by the certificate. § 130.20 User fees for endorsing export The person for whom the service is pro- certificates. vided and the person requesting the (a) User fees for the endorsement of service are jointly and severally liable export health certificates that do not for payment of these user fees in ac- require the verification of tests or vac- cordance with §§ 130.50 and 130.51.

User fee Certificate categories Apr. 29, Oct. 1, 2009– Oct. 1, 2010– Oct. 1, 2011– 2009–Sept. Sept. 30, Sept. 30, Sept. 30, Beginning 30, 2009 2010 2011 2012 Oct. 1, 2012

Animal and nonanimal products ...... $45.00 $47.00 $48.00 $49.00 $51.00 Hatching eggs...... 42.00 44.00 45.00 46.00 48.00 Poultry, including slaughter poultry ...... 42.00 44.00 45.00 46.00 48.00

5 An export health certificate may need to which the animal is being shipped requires be endorsed for an animal being exported one. APHIS endorses export health certifi- from the United States if the country to cates as a service.

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User fee Certificate categories Apr. 29, Oct. 1, 2009– Oct. 1, 2010– Oct. 1, 2011– 2009–Sept. Sept. 30, Sept. 30, Sept. 30, Beginning 30, 2009 2010 2011 2012 Oct. 1, 2012

Ruminants, except slaughter ruminants moving to Canada or Mexico ...... 47.00 48.00 49.00 51.00 52.00 Slaughter animals (except poultry but including ruminants) moving to Canada or Mexico ...... 49.00 51.00 52.00 54.00 56.00 Other endorsements or certifications ...... 34.00 35.00 36.00 37.00 38.00

(b)(1) User fees for the endorsement there will be a maximum user fee of 12 of export health certificates that re- times the hourly rate user fee listed in quire the verification of tests or vac- § 130.30(a) of this part for any single cinations are listed in the following shipment. The person for whom the table. The user fees apply to each ex- service is provided and the person report health certificate 5 endorsed for questing the service are jointly and animals and birds depending on the severally liable for payment of these number of animals or birds covered by user fees in accordance with the provi- the certificate and the number of tests sions in §§ 130.50 and 130.51. or vaccinations required. However,

User fee 1 Number of tests or vaccinations and number of Apr. 29, Oct. 1, 2009– Oct. 1, 2010– Oct. 1, 2011– animals or birds on the certificate 2009–Sept. Sept. 30, Sept. 30, Sept. 30, Beginning 30, 2009 2010 2011 2012 Oct. 1, 2012

1–2 tests or vaccinations Nonslaughter horses to Canada: First horse...... $54.00 $55.00 $57.00 $59.00 $60.00 Each additional horse...... 6.25 6.25 6.50 6.75 7.00 Other animals or birds: First animal...... 107.00 111.00 114.00 117.00 121.00 Each additional animal...... 6.25 6.25 6.50 6.75 7.00 3–6 tests or vaccinations First animal...... 133.00 137.00 141.00 145.00 150.00 Each additional animal ...... 10.00 11.00 11.00 11.00 12.00 7 or more tests or vaccinations First animal...... 154.00 159.00 163.00 168.00 173.00 Each additional animal ...... 12.00 12.00 13.00 13.00 14.00 1 Rabies vaccinations are not included in this number.

(2) If an export certificate covers services for the animals listed on the more than one animal, but the number certificate, and an APHIS user fee is of tests required for different animals payable under § 130.30 of this part for are not the same, the user fee for the the inspection or supervision services certificate is the fee which would be performed by the veterinarian. due if all the animals on the certificate (d) If a service must be conducted on required the same number of tests as a Sunday or holiday or at any other the animal which requires the greatest time outside the normal tour of duty of number of tests. the employee, then reimbursable over- (c) The user fees prescribed in this time, as provided for in part 97 of this section will not apply to an export chapter, must be paid for each service, health certificate if the export health certificate is prepared for endorsement completely at the site of the inspection by an APHIS veterinarian in the course of performing inspection or supervision

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in addition to the user fee listed in this (6) A statement that APHIS agrees to section. provide the inspection services; (7) A statement that the person re- (Approved by the Office of Management and Budget under control number 0579–0055) questing the inspection services, or, if appropriate, his or her agent, agrees to [57 FR 771, Jan. 9, 1992. Redesignated at 58 pay, at the time the agreement is en- FR 67655, Dec. 22, 1993] tered into, a user fee equal to the esti- EDITORIAL NOTE: For FEDERAL REGISTER ci- mated cost of providing the described tations affecting § 130.20, see the List of CFR inspection services for 6 months; and Sections Affected, which appears in the (8) A statement that the person re- Finding Aids section of the printed volume and at www.fdsys.gov. questing the inspection services, or, if appropriate, his or her agent, agrees to § 130.21 [Reserved] maintain a user fee payment account equal to the cost of providing the de- § 130.22 User fees for inspection serv- scribed inspection services for 6 ices outside the United States. months, as calculated monthly by (a) If inspection services (including APHIS. inspection, testing, and supervision (d) APHIS will enter into an agree- services) are performed outside the ment only if qualified personnel can be United States, in accordance with this made available to provide the inspec- title, and the regulations do not con- tion services. tain a provision for payment of the (e) An agreement can be terminated cost of the service, the person request- by either party on 30 days written no- ing the service must pay a user fee tice. under this section. (f) If, at the time an agreement is (b) Any person who wants APHIS to terminated, any unobligated funds re- provide inspection services outside the main in the user fee payment account, United States must contact the Animal APHIS will refund the funds to the per- and Plant Health Inspection Service, son who requested the inspection serv- Veterinary Services, National Center ices, or his or her agent. for Import-Export, 4700 River Road, [57 FR 771, Jan. 9, 1992. Redesignated at 58 Unit 38, Riverdale, Maryland 20737–1231, FR 67655, Dec. 22, 1993; 59 FR 67617, Dec. 30, to make an agreement. 1994] (c) All agreements must include the following: §§ 130.23–130.29 [Reserved] (1) Name, mailing address, and telephone number of either the person re- § 130.30 Hourly rate and minimum questing the inspection services, or his user fees. or her agent; (a) User fees for import- or export-re- (2) Explanation of inspection services lated veterinary services listed in para- to be provided, including the regula- graphs (a)(1) through (a)(18) of this sections in title 9, Code of Federal Regula- tion, except those services covered by tions which provide for the services; flat rate user fees elsewhere in this (3) Date(s) and time(s) the inspection part, will be calculated at the hourly services are to be provided; rate listed in the following table for (4) Location (including street ad- each employee required to perform the dress) where inspection services are to service. The person for whom the serv- be provided; ice is provided and the person request- (5) An estimate of the actual cost, as ing the service are jointly and sever- calculated by APHIS, to provide the ally liable for payment of these user described inspection services for 6 fees in accordance with §§ 130.50 and months; 130.51.

User fee Apr. 29, Oct. 1, 2009– Oct. 1, 2010– Oct. 1, 2011– 2009–Sept. Sept. 30, Sept. 30, Sept. 30, Beginning 30, 2009 2010 2011 2012 Oct. 1, 2012

Hourly rate: Per hour...... $120.00 $120.00 $124.00 $128.00 $132.00

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User fee Apr. 29, Oct. 1, 2009– Oct. 1, 2010– Oct. 1, 2011– 2009–Sept. Sept. 30, Sept. 30, Sept. 30, Beginning 30, 2009 2010 2011 2012 Oct. 1, 2012

Per quarter hour ...... 30.00 30.00 31.00 32.00 33.00 Per service minimum fee ...... 35.00 36.00 37.00 39.00 40.00

(1) Providing services to live animals (11) Conducting inspections under for import or entry at airports, ocean part 156 of this chapter. ports, and rail ports. (12) Inspecting and approving an arti- (2) Conducting inspections, including ficial insemination center or a semen inspections of laboratories and facili- collection center or the animals in it. ties (such as biosecurity level two fa- (13) Import or entry services for feed- cilities), required either to obtain im- er animals including, but not limited port permits for animal products, aqua- to, feeder goats and feeder bison not culture products, or organisms or vec- covered by a flat rate user fee in § 130.7. tors, or to maintain compliance with (14) Export-related bird banding for import permits. This hourly rate does identification. not apply to inspection activities cov- (15) Export-related inspection and ap- ered in § 130.11. proval of pet food facilities, including (3) Obtaining samples required to be laboratories that perform pet food test- tested, either to obtain import permits ing. or to ensure compliance with import (16) Export-related services provided permits. at animal auctions. (4) Providing services for imported (17) Various export-related facility birds or ratites that are not subject to inspections, including, but not limited quarantine, such as monitoring birds— to, fertilizer plants that utilize poultry including but not limited to pet birds— waste, rendering plants, and potential between flights. embarkation facilities. (5) Supervising the opening of in- (18) Providing other import-or ex- bond shipments. port-related veterinary services for (6) Providing services for in-bond or which there is no flat rate user fee in-transit animals to exit the United specified elsewhere in this part. States. (b) When do I pay an additional (7) Inspecting an export isolation fa- amount for employee(s) working overtime? cility and the animals in it. You must pay an additional amount if (8) Supervising animal or bird rest you need an APHIS employee to work periods prior to export. on a Sunday, on a holiday, or at any (9) Supervising loading and unloading time outside the normal tour of duty of of animals or birds for export ship- that employee. Instead of paying the ment. hourly rate user fee, you pay the rate (10) Inspecting means of conveyance listed in the following table for each used to export animals or birds. employee needed to get the work done.

Premium rate user fee Overtime rates (outside the employee’s normal Apr. 29, Oct. 1, 2009– Oct. 1, 2010– Oct. 1, 2011– tour of duty) 2009–Sept. Sept. 30, Sept. 30, Sept. 30, Beginning 30, 2009 2010 2011 2012 Oct. 1, 2012

Premium hourly rate Monday through Saturday and holidays: Per hour...... $140.00 $144.00 $148.00 $152.00 $156.00 Per quarter hour ...... 35.00 36.00 37.00 38.00 39.00 Premium hourly rate for Sundays: Per hour...... 160.00 164.00 168.00 172.00 $176.00 Per quarter hour ...... 40.00 41.00 42.00 43.00 44.00

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(Approved by the Office of Management and vided related to the importation, Budget under control numbers 0579–0055 and entry, or exportation of an animal, ar- 0579–0094) ticle, or means of conveyance or re- [65 FR 52009, Aug. 28, 2000, as amended at 68 lated to veterinary diagnostics, and FR 51886, Aug. 29, 2003; 72 FR 70766, Dec. 13, any person requesting such service, 2007; 74 FR 14006, Mar. 30, 2009] shall be jointly and severally liable for payment of fees assessed. §§ 130.31–130.48 [Reserved] (b) Associated charges—(1) Reservation § 130.49 Exemptions. fee. Any reservation fee paid by an importer under part 93 of this chapter will (a) Veterinary diagnostics. User fees be applied to the APHIS user fees spec- for veterinary diagnostic services, in- ified in §§ 130.2 and 130.3 for animals or cluding, but not limited to, tests and birds quarantined in an animal import diagnostic reagents specified in §§ 130.14 center. through 130.19, are not charged under (2) Special handling expenses. The user the following conditions: fees in this part do not include any (1) When veterinary diagnostic serv- costs that may be incurred due to spe- ices are provided in connection with cial mail handling, including, but not Federal programs to control or eradi- limited to, express, overnight, or for- cate diseases or pests of livestock or eign mailing. If any service requires poultry in the United States (program special mail handling, the user must diseases); pay all costs incurred, in addition to (2) When veterinary diagnostic serv- the user fee for the service. ices are provided in support of zoonotic (3) When do I pay an additional disease surveillance when the Adminis- amount for employee(s) working overtime? trator has determined that there is a You must pay an additional amount if significant threat to human health; you need an APHIS employee to work and on a Sunday, on a holiday, or at any (3) When veterinary diagnostic re- time outside the normal tour of duty of agents are distributed within the that employee. You pay the amount United States for testing for foreign specified in paragraphs (b)(3) (i) or (ii), animal diseases. as relevant, for each employee needed (b) [Reserved] to get the work done. [62 FR 61007, Nov. 14, 1997, as amended at 63 (i) What additional amount do I pay if FR 53796, Oct. 7, 1998] I receive a flat rate user fee service? In addition to the flat rate user fee(s), you § 130.50 Payment of user fees. pay the overtime rate listed in the fol- (a) Who must pay APHIS user fees? lowing table for each employee needed Any person for whom a service is pro- to get the work done:

OVERTIME FOR FLAT RATE USER FEES 1,2

Overtime rates (per hour) Outside of the employee’s normal tour of duty Oct. 1, 2003– Oct. 1, 2004– Beginning Sept. 30, 2004 Sept. 30, 2005 Oct. 1, 2005

Rate for inspection, testing, certification Monday-Saturday and holi- $48.00 $49.00 $51.00 or quarantine of animals, animal prod- days. ucts or other commodities. 3. Sundays ...... 63.00 65.00 67.00 Rate for commercial airline inspection Monday-Saturday and holi- 39.00 40.00 41.00 services. 4. days. Sundays ...... 51.00 53.00 55.00 1 Minimum charge of 2 hours, unless performed on the employee’s regular workday and performed in direct continuation of the regular workday or begun within an hour of the regular workday. 2 When the 2-hour minimum applies, you may need to pay commuted travel time. (See § 97.1(b) of this chapter for specific information about commuted travel time.) 3 See § 97.1(a) of this chapter or 7 CFR 354.3 for details. 4 See § 97.1(a)(3) of this chapter for details.

(ii) What amount do I pay if I receive paying the normal hourly rate user fee an hourly rate user fee service? Instead of under § 130.30(a), you pay the premium

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rate listed in § 130.30(b) for each em- made at an APHIS office 7 or an Animal ployee needed to get the work done. Import Center; (c) When are APHIS user fees due?—(1) (2) All types of checks, including Animal and bird quarantine and related traveler’s checks, drawn on a U.S. bank tests. User fees specified in §§ 130.2, 130.3, in U.S. dollars and made payable to the 130.5, 130.10, and tests specified in U.S. Department of Agriculture or §§ 130.14 through 130.19 for animals and USDA; birds in an Animal Import Center or (3) Money orders, drawn on a U.S. privately operated permanent or tem- bank in U.S. dollars and made payable porary import quarantine facilities, in- to the U.S. Department of Agriculture cluding user fees for tests conducted on or USDA; or TM these animals or birds, must be paid (4) Credit cards (VISA and TM prior to the release of those animals or MasterCard ) if payment is made at birds from quarantine. an Animal Import Center or an APHIS office that is equipped to process credit (2) Supervision and inspection services cards. 7 for export animals, animal products. User fees for supervision and inspection [63 FR 53796, Oct. 7, 1998, as amended at 64 FR services specified in § 130.30 must be 67700, Dec. 3, 1999; 65 FR 52010, Aug. 28, 2000; paid when billed, or, if covered by a 67 FR 48524, July 25, 2002; 68 FR 51887, Aug. 29, compliance agreement signed in ac- 2003] cordance with this chapter, must be § 130.51 Penalties for nonpayment or paid when specified in the agreement. late payment. (3) Export health certificates. User fees (a) Unpaid debt. If any person for for export health certificates specified whom the service is provided fails to in § 130.20 must be paid prior to receipt pay when due any debt to APHIS, in- of endorsed certificates unless APHIS cluding any user fee due under 7 CFR determines that the user has estab- chapter III or chapter I of this title, lished an acceptable credit history, at then: which time payment may, at the op- (1) Subsequent user fee payments. Pay- tion of the user, be made when billed. ment must be made for subsequent user (4) Veterinary diagnostics. User fees fees before the service is provided if: specified in §§ 130.14 through 130.19 for (i) For unbilled fees, the user fee is veterinary diagnostic services, such as unpaid 60 days after the date the perti- tests on samples submitted to NVSL or nent regulatory provision indicates FADDL, diagnostic reagents, slide sets, payment is due; tissue sets, and other veterinary diag- (ii) For billed fees, the user fee is un- nostic services, must be paid when the paid 60 days after date of bill; veterinary diagnostic service is re- (iii) The person for whom the service quested, unless APHIS determines that is provided or the person requesting the user has established an acceptable the service has not paid the late pay- credit history, at which time payment ment penalty or interest on any delin- may, at the option of the user, be made quent APHIS user fee; or when billed. (iv) Payment has been dishonored. (5) Other user fee services. User fees (2) Resolution of difference between es- specified in §§ 130.6, 130.7, 130.8, and timate and actual. APHIS will estimate 130.30 must be paid when service is pro- the user fee to be paid; any difference vided (for example when live animals between the estimate and the actual are inspected when presented for im- amount owed to APHIS will be resolved portation at a port of entry), unless as soon as reasonably possible fol- APHIS determines that the user has es- lowing the delivery of the service, with tablished an acceptable credit history, APHIS returning any excess to the at which time payment may, at the option of the user, be made when billed. 7 A list of APHIS offices and Animal Im- (d) What payment methods are accept- port Centers that accept cash or credit cards able? Payment must be for the exact may be obtained from the Animal and Plant amount due and may be paid by: Health Inspection Service, Veterinary Serv- ices, National Center for Import and Export, (1) Cash, will be accepted only during 4700 River Road Unit 38, Riverdale, MD 20738– normal business hours if payment is 1231.

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payor or billing the payor for the addi- ment, such as a check returned for in- tional amount due. sufficient funds, will be subject to in- (3) Prepayment form. The prepayment terest and penalty charges in accord- must be in guaranteed form, such as ance with 31 U.S.C. 3717. Administra- money order, certified check, or cash. tive charges will be assessed at $20.00 Prepayment in guaranteed form will per dishonored payment to be paid in continue until the debtor pays the de- addition to the original amount owed. linquent debt. Payment must be in guaranteed form, (4) Denied service. Service will be de- such as cash, money order, or certified nied until the debt is paid if: check. (i) For unbilled fees, the user fee is (e) Debt collection management. In ac- unpaid 90 days after date the pertinent cordance with the Debt Collection Im- regulatory provision indicates payment provement Act of 1996, the following is due; provisions apply: (ii) For billed fees, the user fee is un- (1) Taxpayer identification number. paid 90 days after date of bill; APHIS will collect a taxpayer identi- (iii) The person for whom the service fication number from all persons, other is provided or the person requesting than Federal agencies, who are liable the service has not paid the late pay- for a user fee. ment penalty or interest on any delin- (2) Administrative offset. APHIS will quent APHIS user fee; or notify the Department of Treasury of (iv) Payment has been dishonored. debts that are over 180 days delinquent (b) Unpaid debt during service. If for the purposes of administrative off- APHIS is in the process of providing a set. Under administrative offset, the service for which an APHIS user fee is Department of Treasury will withhold due, and the user has not paid the fee funds payable by the United States to within the time required, or if the pay- a person (i.e., Federal income tax re- ment offered by the user is inadequate funds) to satisfy the debt to APHIS. or unacceptable, then APHIS will take the following action: (3) Cross-servicing. APHIS will trans- (1) Animals or birds in quarantine. If an fer debts that are over 180 days delin- APHIS user fee specified in § 130.2 or quent to the Department of Treasury § 130.3 is due for animals or birds in for cross-servicing. Under cross-serv- quarantine at an animal import center icing, the Department of Treasury will or at a privately operated import quar- collect debts on behalf of APHIS. Ex- antine facility, APHIS will not release ceptions will be made for debts that them. meet certain requirements, for exam- (2) Export health certificate. If an ple, debts that are already at a collec- APHIS user fee specified in § 130.20 is tion agency or in payment plan. due for an export health certificate, (4) Report delinquent debt. APHIS will APHIS will not release the certificate. report all unpaid debts to credit report- (3) Veterinary diagnostics. If an APHIS ing bureaus. user fee specified in §§ 130.14 through (f) Animals or birds abandoned after 130.19 is due for a veterinary diagnostic quarantine at an animal import center. test or service, APHIS will not release Animals or birds left in quarantine at the test result, any endorsed certifi- an animal import center for more than cate, or any other veterinary diag- 30 days after the end of the required nostic service. quarantine period will be deemed to be (c) Late payment penalty. If for abandoned. unbilled user fees, the user fees are un- (1) After APHIS releases the aban- paid 30 days after the date the perti- doned animals or birds from quar- nent regulatory provisions indicates antine, APHIS may seize them and sell payment is due, or if billed, are unpaid or otherwise dispose of them, as deter- 30 days after the date of the bill, mined by the Administrator, provided APHIS will impose a late payment pen- that their sale is not contrary to any alty and interest charges in accordance Federal law or regulation, and may re- with 31 U.S.C. 3717. cover all expenses of handling the ani- (d) Dishonored payment penalties. User mals or birds from the proceeds of their fees paid with dishonored forms of pay- sale or disposition.

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(2) If animals or birds abandoned in dling the animals or birds from the quarantine at an animal import center proceeds of their disposition and from cannot be released from quarantine, persons liable for user fees under APHIS may seize and dispose of them, § 130.50(a). as determined by the Administrator, [63 FR 53797, Oct. 7, 1998, as amended at 68 FR and may recover all expenses of han- 6346, Feb. 7, 2003]

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PART 145—NATIONAL POULTRY IM- 145.44 Terminology and classification; PROVEMENT PLAN FOR BREED- States. ING POULTRY Subpart E—Special Provisions for Hobbyist and Exhibition Waterfowl, Exhibition Subpart A—General Provisions Poultry, and Game Bird Breeding Flocks and Products Sec. 145.1 Definitions. 145.51 Definitions. 145.2 Administration. 145.52 Participation. 145.3 Participation. 145.53 Terminology and classification; 145.4 General provisions for all participants. flocks and products. 145.5 Specific provisions for participating 145.54 Terminology and classification; flocks. States. 145.6 Specific provisions for participating hatcheries. Subpart F—Special Provisions for Ostrich, 145.7 Specific provisions for participating Emu, Rhea, and Cassowary Breeding dealers. Flocks and Products 145.8 Terminology and classification; general. 145.61 Definitions. 145.9 Terminology and classification; hatch- 145.62 Participation. eries and dealers. 145.63 Terminology and classification; 145.10 Terminology and classification; flocks and products. flocks, products, and States. 145.11 Supervision. Subpart G—Special Provisions for Primary 145.12 Inspections. Egg-Type Chicken Breeding Flocks 145.13 Debarment from participation. and Products 145.14 Testing. 145.15 Diagnostic surveillance program for 145.71 Definitions. low pathogenic avian influenza. 145.72 Participation. 145.73 Terminology and classification; Subpart B—Special Provisions for Multiplier flocks and products. Egg-Type Chicken Breeding Flocks and Products Subpart H—Special Provisions for Primary Meat-Type Chicken Breeding Flocks 145.21 Definitions. and Products 145.22 Participation. 145.23 Terminology and classification; 145.81 Definitions. flocks and products. 145.82 Participation. 145.24 Terminology and classification; 145.83 Terminology and classification; States. flocks and products.

Subpart C—Special Provisions for Multiplier Subpart I—Special Provisions for Meat- Meat-Type Chicken Breeding Flocks Type Waterfowl Breeding Flocks and and Products Products

145.31 Definitions. 145.91 Definitions. 145.32 Participation. 145.92 Participation. 145.33 Terminology and classification; 145.93 Terminology and classification; flocks and products. flocks and products. 145.34 Terminology and classification; 145.94 Terminology and classification; States. States. Subpart D—Special Provisions for Turkey AUTHORITY: 7 U.S.C. 8301–8317; 7 CFR 2.22, Breeding Flocks and Products 2.80, and 371.4. SOURCE: 36 FR 23112, Dec. 3, 1971, unless 145.41 Definitions. otherwise noted. Redesignated at 44 FR 61586, 145.42 Participation. Oct. 26, 1979. 145.43 Terminology and classification; flocks and products.

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Subpart A—General Provisions commerce in buying and selling poultry for slaughter only. § 145.1 Definitions. Department. The U.S. Department of Words used in this part in the sin- Agriculture. gular form shall be deemed to import Domesticated. Propagated and main- the plural, and vice versa, as the case tained under the control of a person. may demand. Except where the context Equivalent or equivalent requirements. otherwise requires, for the purposes of Requirements which are equal to or ex- this part the following terms shall be ceed the program, conditions, criteria, construed, respectively, to mean: or classifications with which they are Administrator. The Administrator, compared, as determined by the Offi- Animal and Plant Health Inspection cial State Agency and with the concur- Service, or any person authorized to rence of the Service. act for the Administrator. Exposed (Exposure). Contact with Affiliated flockowner. A flockowner birds, equipment, personnel, supplies, who is participating in the Plan or any article infected with, or con- through an agreement with a partici- taminated by, communicable poultry pating hatchery. disease organisms. Animal and Plant Health Inspection Service. The Animal and Plant Health Flock—(1) As applied to breeding. All Inspection Service of the U.S. Depart- poultry of one kind of mating (breed ment of Agriculture. and variety or combination of stocks) Authorized agent. Any person des- and of one classification on one farm; ignated under § 145.11(a) to collect offi- (2) As applied to disease control. All of cial samples for submission to an au- the poultry on one farm except that, at thorized laboratory as described in the discretion of the Official State §§ 147.1(a) and 147.12 of this subchapter. Agency, any group of poultry which is Authorized laboratory. An authorized segregated from another group and has laboratory is a laboratory that meets been so segregated for a period of at the requirements of § 147.51 and is thus least 21 days may be considered as a qualified to perform the assays de- separate flock. scribed in part 147 of this subchapter. Fluff sample. Feathers, shell mem- Authorized testing agent. Any person brane, and other debris resulting from designated under § 145.11(a) to collect the hatching of poultry. official samples for submission to an Fowl typhoid or typhoid. A disease of authorized laboratory as described in poultry caused by Salmonella §§ 147.1(a) and 147.12 of this subchapter gallinarum. and to perform the stained antigen, Franchise breeder. A breeder who nor- rapid whole blood test for pullorum ty- mally sells products under a specific phoid. strain or trade name and who author- Avian influenza. An infection or dis- izes other hatcheries to produce and ease of poultry caused by viruses in the sell products under this same strain or family Orthomyxoviridae, genus trade name. Influenzavirus A. Franchise hatchery. A hatchery which Baby poultry. Newly hatched poultry (chicks, poults, ducklings, goslings, has been authorized by a franchise keets, etc.). breeder to produce and sell products Colon bacilli. For the purpose of this under the breeder’s strain or trade chapter, those organisms which are name. gram negative, non spore-forming ba- Hatchery. Hatchery equipment on one cilli, which ferment lactose with gas premises operated or controlled by any formation, and serve as an index of person for the production of baby poul- fecal contamination. try. Dealer. An individual or business that Independent flock. A flock that pro- deals in commerce in hatching eggs, duces hatching eggs and that has no newly-hatched poultry, and started ownership affiliation with a specific poultry obtained from breeding flocks hatchery. and hatcheries. This does not include Infected flock. A flock in which an au- an individual or business that deals in thorized laboratory has discovered one

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or more birds infected with a commu- Program. Management, sanitation, nicable poultry disease for which a pro- testing, and monitoring procedures gram has been established under the which, if complied with, will qualify, Plan. and maintain qualification for, des- Midlay. Approximately 2–3 months ignation of a flock, products produced after a flock begins to lay or after a from the flock, or a state by an official molted flock is put back into produc- Plan classification and illustrative de- tion. sign, as described in § 145.10 of this Multiplier breeding flock. A flock that part. is intended for the production of hatch- Public exhibition. A public show of ing eggs used for the purpose of pro- poultry. ducing progeny for commercial egg or Pullorum disease or pullorum. A dis- meat production or for other non- ease of poultry caused by Salmonella breeding purposes. pullorum. NPIP Technical Committee. A com- Reactor. A bird that has a positive re- mittee made up of technical experts on action to a test, required or rec- poultry health, biosecurity, surveil- ommended in parts 145 or 147 of this lance, and diagnostics. The committee chapter, for any poultry disease for consists of representatives from the which a program has been established poultry and egg industries, univer- under the Plan. sities, and State and Federal govern- Salmonella. Any bacteria belonging to ments and is appointed by the Senior the genus Salmonella, including the ar- Coordinator and approved by the Gen- izona group. eral Conference Committee. Sanitize. To treat with a product Official State Agency. The State au- which is registered by the Environ- thority recognized by the Department mental Protection Agency as germi- to cooperate in the administration of cidal, fungicidal, pseudomonocidal, or the Plan. tuberculocidal, in accordance with the Official supervision—(1) As applied to specifications for use as shown on the Plan programs. The direction, inspec- label of each product. The Official tion, and critical evaluation by the Of- State Agency, with the concurrence of ficial State Agency of compliance with the Service, shall approve each product the provisions of the Plan; or procedure according to its specified (2) As applied to non-Plan but equiva- usage. lent State poultry improvement programs. Senior Coordinator. An employee of The direction, inspection, and critical the Service whose duties may include, evaluation by an officer or agency of a but will not necessarily be limited to: State government, of compliance with (1) Serving as executive secretary of a publicly announced State poultry im- the General Conference Committee; provement program. (2) Serving as chairperson of the Plan Person. A natural person, firm, or Conference described in § 147.47; corporation. (3) Planning, organizing, and con- Plan. The provisions of the National ducting the Plan Conference; Poultry Improvement Plan contained (4) Reviewing NPIP authorized lab- in this part. oratories as described in § 147.51; Poultry. Domesticated fowl, including (5) Coordinating the State adminis- chickens, turkeys, ostriches, emus, tration of the NPIP through periodic rheas, cassowaries, waterfowl, and reviews of the administrative proce- game birds, except doves and pigeons, dures of the Official State Agencies, which are bred for the primary purpose according to the applicable provisions of producing eggs or meat. of the Plan and the Memorandum of Primary breeding flock. A flock com- Understanding; posed of one or more generations that (6) Coordinating rulemaking to incor- is maintained for the purpose of estab- porate the proposed changes of the pro- lishing, continuing, or improving par- visions approved at the Plan con- ent lines. ference into the regulations in parts Products. Poultry breeding stock and 145, 146, and 147 of this subchapter; hatching eggs, baby poultry, and start- (7) Directing the production of offi- ed poultry. cial NPIP publications;

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(8) Proposing an annual budget for in the administration of the Plan. In plan activities and the General Con- the Memorandum of Understanding, ference Committee; and the Official State Agency must des- (9) Providing overall administration ignate a contact representative to of the NPIP. serve as a liaison between the Service Service. The Animal and Plant Health and the Official State Agency. Inspection Service, Veterinary Serv- (b) The administrative procedures ices, of the Department. and decisions of the Official State Serial. The total quantity of com- Agency are subject to review by the pleted product which has been thor- Service. The Official State Agency oughly mixed in a single container and shall carry out the administration of identified by a serial number. the Plan within the State according to Sexual maturity. The average age at the applicable provisions of the Plan which a species of poultry is bio- and the Memorandum of Under- logically capable of reproduction. standing. Started poultry. Young poultry (c) An Official State Agency may ac- (chicks, pullets, cockerels, capons, cept for participation an affiliated poults, ducklings, goslings, keets, etc.) flock located in another State under a that have been fed and watered and are mutual understanding and agreement, less than 6 months of age. in writing, between the two Official State. Any State, the District of Co- State Agencies regarding conditions of lumbia, or Puerto Rico. participation and supervision. State Inspector. Any person employed (d) The Official State Agency of any or authorized under § 145.11(b) to per- State may, except as limited by form functions under this part. § 145.3(d), adopt regulations applicable Stock. A term used to identify the to the administration of the Plan in progeny of a specific breeding combina- such State further defining the provi- tion within a species of poultry. These sions of the Plan or establishing higher breeding combinations may include standards compatible with the Plan. pure strains, strain crosses, breed (e) An authorized laboratory of the crosses, or combinations thereof. National Poultry Improvement Plan Strain. Poultry breeding stock bear- will follow the laboratory protocols ing a given name produced by a breeder outlined in part 147 of this chapter through at least five generations of when determining the status of a par- closed flock breeding. ticipating flock with respect to an offi- Succeeding flock. A flock brought onto cial Plan classification. a premises during the 12 months following removal of an infected flock. (Approved by the Office of Management and Suspect flock. A flock shall be consid- Budget under control number 0579–0007) ered, for the purposes of the Plan, to be [36 FR 23112, Dec. 3, 1971. Redesignated at 44 a suspect flock if any evidence exists FR 61586, Oct. 26, 1979, and amended at 48 FR that it has been exposed to a commu- 57473, Dec. 30, 1983; 67 FR 8468, Feb. 25, 2002; nicable poultry disease. 74 FR 14714, Apr. 1, 2009] Trade name or number. A name or number compatible with State and § 145.3 Participation. Federal laws and regulations applied to (a) Any person producing or dealing a specified stock or product thereof. in products may participate in the [36 FR 23112, Dec. 3, 1971. Redesignated at 44 Plan when he has demonstrated, to the FR 61586, Oct. 26, 1979] satisfaction of the Official State Agen- cy, that his facilities, personnel, and EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 145.1, see the List of CFR practices are adequate for carrying out Sections Affected, which appears in the the applicable provisions of the Plan, Finding Aids section of the printed volume and has signed an agreement with the and at www.fdsys.gov. Official State Agency to comply with the general and the applicable specific § 145.2 Administration. provisions of the Plan and any regula- (a) The Department cooperates tions of the Official State Agency through a Memorandum of Under- under § 145.2. Affiliated flockowners standing with Official State Agencies may participate without signing an

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agreement with the Official State Agency. (b) Each participant shall comply with the Plan throughout the operating year of the Official State Agency, or until released by such Agency. (c) A participant in any State shall participate with all of his poultry hatching egg supply flocks and hatchery operations within such State. He shall report to the Official State Agen- cy on VS Form 9–2 (formerly NPIP Form 3B) or through other appropriate means each breeding flock before the birds reach 24 weeks of age or, in the case of ostriches, emus, rheas, cassowaries, before the birds reach 20 months of age. This report will include: (1) Name and address of flockowner; (2) Flock location and designation; (3) Type: Primary or Multiplier; (4) Breed, variety, strain, or trade name of stock; (5) Source of males; (6) Source of females; (Approved by the Office of Management and Budget under control number 0579–0007) (7) Number of birds in the flock; and (8) Intended classification of flock. [36 FR 23112, Dec. 3, 1971, as amended at 40 FR 1500, Jan. 8, 1975. Redesignated at 44 FR (d) No person shall be compelled by 61586, Oct. 26, 1979 and amended at 48 FR the Official State Agency to qualify 57473, Dec. 30, 1983; 57 FR 57341, Dec. 4, 1992; products for any of the other classifica- 63 FR 40010, July 27, 1998; 65 FR 8016, Feb. 17, tions described in § 145.10 as a condition 2000] of qualification for the U.S. Pullorum- Typhoid Clean classification. § 145.4 General provisions for all participants. (e) Participation in the Plan shall entitle the participant to use the Plan (a) Records of purchases and sales emblem reproduced below: and the identity of products handled shall be maintained in a manner satisfactory to the Official State Agency. (b) Products, records of sales and purchase of products, and material used to advertise products shall be subject to inspection by the Official State Agency at any time. (c) Advertising must be in accordance with the Plan, and applicable rules and regulations of the Official State Agen- cy and the Federal Trade Commission. A participant advertising products as being of any official classification may include in his advertising reference to associated or franchised hatcheries only when such hatcheries produce the same kind of products of the same classification. (d) Except as provided by this paragraph, participants in the Plan may not buy or receive products for any

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purpose from nonparticipants unless (b) All flocks shall consist of healthy, they are part of an equivalent program, normal individuals characteristic of as determined by the Official State the breed, variety, cross, or other com- Agency. Participants in the Plan may bination which they are stated to rep- buy or receive products from flocks resent. that are neither participants nor part (c) A flock shall be deemed to be a of an equivalent program, for use in participating flock at any time only if breeding flocks or for experimental it has qualified for the U.S. Pullorum- purposes, under the following condi- Typhoid Clean classification, as pre- tions only: scribed in Subparts B, C, D, E, or F of (1) With the permission of the Offi- this part. cial State Agency and the concurrence (d) Each bird shall be identified with of the Service; and a sealed and numbered band obtained (2) By segregation of all birds before through or approved by the Official introduction into the breeding flock. State Agency: Provided, That exception Upon reaching sexual maturity, the may be made at the discretion of the segregated birds must be tested and Official State Agency. found negative for pullorum-typhoid. [36 FR 23112, Dec. 3, 1971, as amended at 38 The Official State Agency may require FR 13706, May 24, 1973. Redesignated at 44 FR a second test at its discretion. 61586, Oct. 26, 1979, as amended at 63 FR 40010, (e) Each participant shall be assigned July 27, 1998] a permanent approval number by the Service. This number, prefaced by the § 145.6 Specific provisions for partici- numerical code of the State, will be the pating hatcheries. official approval number of the partici- (a) Hatcheries must be kept in sani- pant and may be used on each certifi- tary condition, acceptable to the Offi- cate, invoice, shipping label, or other cial State Agency. The procedures out- document used by the participant in lined in §§ 147.22 through 147.25 of this the sale of his products. Each Official chapter will be considered as a guide in State Agency which requires an ap- determining compliance with this pro- proval or permit number for out-of- vision. The minimum requirements State participants to ship into its with respect to sanitation include the State should honor this number. The following: approval number shall be withdrawn (1) Egg room walls, ceilings, floors, when the participant no longer quali- air filters, drains, and humidifiers fies for participation in the Plan. should be cleaned and disinfected at (Approved by the Office of Management and least two times per week. Cleaning and Budget under control number 0579–0057) disinfection procedures should be as outlined in § 147.24 of this chapter. [36 FR 23112, Dec. 3, 1971, as amended at 38 FR 13706, May 24, 1973; 41 FR 48723, Nov. 5, (2) Incubator room walls, ceilings, 1976. Redesignated at 44 FR 61586, Oct. 26, floors, doors, fan grills, vents, and 1979, as amended at 47 FR 21991, May 20, 1982; ducts should be cleaned and disinfected 48 FR 57473, Dec. 30, 1983; 57 FR 57341, Dec. 4, after each set or transfer. Incubator 1992] rooms should not be used for storage. Plenums should be cleaned at least § 145.5 Specific provisions for partici- weekly. Egg trays and buggies should pating flocks. be cleaned and disinfected after each (a) Poultry equipment, and poultry transfer. Cleaning and disinfection pro- houses and the land in the immediate cedures should be as outlined in § 147.24 vicinity thereof, shall be kept in sani- of this chapter. tary condition as recommended in (3) Hatcher walls, ceilings, floors, §§ 147.21 and 147.22 (a) and (e) of this doors, fans, vents, and ducts should be chapter. The participating flock, its cleaned and disinfected after each eggs, and all equipment used in connec- hatch. Hatcher rooms should be tion with the flock shall be separated cleaned and disinfected after each from nonparticipating flocks, in a hatch and should not be used for stor- manner acceptable to the Official State age. Plenums should be cleaned after Agency. each hatch. Cleaning and disinfection

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procedures should be as outlined in § 145.7 Specific provisions for partici- § 147.24 of this chapter. pating dealers. (4) Chick/poult processing equipment Dealers in poultry breeding stock, and rooms should be thoroughly hatching eggs, or baby or started poul- cleaned and disinfected after each try shall comply with all provisions in hatch. Chick/poult boxes should be this part which apply to their oper- cleaned and disinfected before being re- ations. used. Vaccination equipment should be cleaned and disinfected after each use. § 145.8 Terminology and classification; Cleaning and disinfection procedures general. should be as outlined in § 147.24 of this (a) The official classification terms chapter. defined in §§ 145.9 and 145.10 and the (5) Hatchery residue, such as chick/ various designs illustrative of the offi- poult down, eggshells, infertile eggs, cial classifications reproduced in and dead germs, should be disposed of § 145.10 may be used only by partici- promptly and in a manner satisfactory pants and to describe products that to the Official State Agency. have met all the specific requirements (6) The entire hatchery should be of such classifications. kept in a neat, orderly condition and (b) Products produced under the Plan cleaned and disinfected after each shall lose their identity under Plan ter- hatch. minology when they are purchased for (7) Effective insect and rodent con- resale by or consigned to nonpartici- trol programs should be implemented. pants. (b) A hatchery that keeps started (c) Participating flocks, their eggs, poultry must keep such poultry sepa- and the baby and started poultry pro- rated from the incubator room in a duced from them may be designated by manner satisfactory to the Official their strain or trade name. When a State Agency. breeder’s trade name or strain designa- (c) All baby and started poultry of- tion is used, the participant shall be fered for sale under Plan terminology able by records to substantiate that should be normal and typical of the the products so designated are from breed, variety, cross, or other combina- flocks that are composed of either tion represented. birds hatched from eggs produced (d) Eggs incubated should be sound in under the direct supervision of the shell, typical for the breed, variety, breeder of such strain, or stock multi- strain, or cross thereof and reasonably plied by persons designated and so re- uniform in shape. Hatching eggs should ported by the breeder to each Official be trayed and the baby poultry boxed State Agency concerned. with a view to uniformity of size. (e) Any nutritive material provided § 145.9 Terminology and classification; to baby poultry must be free of the hatcheries and dealers. avian pathogens that are officially rep- Participating hatcheries and dealers resented in the Plan disease classifica- shall be designated as ‘‘National Plan tions listed in § 145.10. Hatchery’’ and ‘‘National Plan Deal- (f) If a person is responsibly con- er’’, respectively. All Official State nected with more than one hatchery, Agencies shall be notified by the Serv- all of such hatcheries must participate ice of additions, withdrawals, and in the Plan if any of them participate. changes in classification. A person is deemed to be responsibly [36 FR 23112, Dec. 3, 1971. Redesignated at 44 connected with a hatchery if he or she FR 61586, Oct. 26, 1979, and amended at 47 FR is a partner, officer, director, holder, 21991, May 20, 1982] owner of 10 percent or more of the voting stock, or an employee in a manage- § 145.10 Terminology and classifica- rial or executive capacity. tion; flocks, products, and States. [36 FR 23112, Dec. 3, 1971. Redesignated at 44 Participating flocks, products pro- FR 61586, Oct. 26, 1979, and amended at 49 FR duced from them, and States that have 19802, May 10, 1984; 65 FR 8016, Feb. 17, 2000; met the requirements of a classifica- 67 FR 8468, Feb. 25, 2002] tion in this part may be designated by

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the corresponding illustrative design in (e) U.S. M. Synoviae Clean. (See this section. § 145.23(e), § 145.23(g), § 145.33(e), (a) [Reserved] § 145.33(g), § 145.43(e), and § 145.53(d)). (b) U.S. Pullorum-Typhoid Clean. (See § 145.23(b), § 145.33(b), § 145.43(b), §§ 145.53(b), and 145.63(a).)

(f) U.S. M. Meleagridis Clean—(See § 145.43(d)). (c) U.S. M. Gallisepticum Clean. (See § 145.23(c), § 145.23(f), § 145.33(c), § 145.33(f), § 145.43(c), and § 145.53(c).)

(d) U.S. Sanitation Monitored. (See § 145.33(d).) (g) U.S. Pullorum-Typhoid Clean State. (See § 145.24(a), § 145.34(a), § 145.44(a), and § 145.54(a).)

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(i) U.S.M. Gallisepticum Clean State, (h) U.S. Pullorum-Typhoid Clean State, Turkeys. (See § 145.44(c).) Turkeys. (See § 145.44(b).)

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(k) U.S. Sanitation Monitored, Turkeys. (See § 145.43(f).)

FIGURE 12 (l) [Reserved] (m) U.S. S. Enteritidis Clean. (See § 145.23(d) and § 145.33(h).)

(j) U.S. M. Gallisepticum Clean State, Meat-Type Chickens. (See § 145.34(b).)

(n) U.S. M. Synoviae Clean State, Tur- keys. (See § 145.44(d).)

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(p) U.S. M. Gallisepticum Monitored. (See § 145.33(j).)

(q) U.S. M. Synoviae Monitored. (See § 145.33(k).)

(o) U.S. Salmonella Monitored. (See § 145.33(i).)

(r) U.S. Avian Influenza Clean. (See §§ 145.23(h), 145.33(l), 145.63(b), 145.73(f), and 145.83(g).)

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(s) U.S. M. Meleagridis Clean State, Turkeys. (See § 145.44(e).)

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(t) U.S. H5/H7 Avian Influenza Clean. person has been given notice of the pro- (See §§ 145.43(g), 145.53(e), and 145.93(b).) posed action and the basis therefor and an opportunity to present his views. [36 FR 23112, Dec. 3, 1971, as amended at 38 FR 13706, May 24, 1973; 41 FR 48723, Nov. 5, 1976. Redesignated at 44 FR 61586, Oct. 26, 1979, as amended at 72 FR 1418, Jan. 12, 2007]

§ 145.12 Inspections. (a) Each participating hatchery shall be audited at least one time annually or a sufficient number of times each year to satisfy the Official State Agen- cy that the operations of the hatchery are in compliance with the provisions of the Plan. (b) The records of all flocks maintained primarily for production of hatching eggs shall be examined annually by a State Inspector. Records shall include VS Form 9–2, ‘‘Flock Selecting and Testing Report’’; VS Form 9–3, ‘‘Report of Sales of Hatching Eggs, Chicks, and Poults’’; set and hatch records; egg receipts; and egg/chick or- [38 FR 13706, May 24, 1973. Redesignated at 44 FR 61586, Oct. 26, 1979] ders or invoices. Records shall be maintained for 3 years. On-site inspections EDITORIAL NOTE: For FEDERAL REGISTER ci- of flocks and premises will be con- tations affecting § 145.10, see the List of CFR Sections Affected, which appears in the ducted if the State Inspector deter- Finding Aids section of the printed volume mines that a breach of sanitation, and at www.fdsys.gov. blood testing, or other provisions has occurred for Plan programs for which § 145.11 Supervision. the flocks have or are being qualified. (a) The Official State Agency may [36 FR 23112, Dec. 3, 1971, as amended at 40 designate qualified persons as Author- FR 1501, Jan. 8, 1975. Redesignated at 44 FR ized Agents to do the sample collecting 61586, Oct. 26, 1979, and amended at 54 FR provided for in § 145.14 and may des- 23955, June 5, 1989; 59 FR 12798, Mar. 18, 1994; ignate qualified persons as Authorized 72 FR 1418, Jan. 12, 2007] Testing Agents to do the sample collecting and blood testing provided for § 145.13 Debarment from participation. in § 145.14. Participants in the Plan, who after (b) The Official State Agency shall investigation by the Official State employ or authorize qualified persons Agency or its representative, are noti- as State Inspectors to perform the fied in writing of their apparent non- qualification testing of participating compliance with the Plan provisions or flocks, and to perform the official in- regulations of the Official State Agen- spections necessary to verify compli- cy, shall be afforded a reasonable time, ance with the requirements of the as specified by the Official State Agen- Plan. cy, within which to demonstrate or (c) Authorities issued under the pro- achieve compliance. If compliance is visions of this section shall be subject not demonstrated or achieved within to cancellation by the official State the specified time, the Official State agency on the grounds of incompetence Agency may debar the participant from or failure to comply with the provi- further participation in the Plan for sions of the Plan or regulations of the such period, or indefinitely, as the official State agency. Such actions Agency may deem appropriate. The shall not be taken until a thorough in- debarred participant shall be afforded vestigation has been made by the offi- notice of the bases for the debarment cial State agency and the authorized and opportunity to present his views

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with respect to the debarment in ac- wary program in § 145.63(a), the min- cordance with procedures adopted by imum number tested shall be 30 birds the Official State Agency. The Official per house, with at least 1 bird taken State Agency shall thereupon decide from each pen and unit in the house. whether the debarment order shall con- The ratio of male to female birds in tinue in effect. Such decision shall be representative samples of birds from final unless the debarred participant, meat-type chicken, waterfowl, exhi- within 30 days after the issuance of the bition poultry, and game bird flocks debarment order, requests the Admin- must be the same as the ratio of male istrator to determine the eligibility of to female birds in the flock. In houses the debarred participant for participa- containing fewer than 30 birds other tion in the Plan. In such event the Ad- than ostriches, emus, rheas, and casso- ministrator shall determine the matter waries, all birds in the house must be de novo in accordance with the rules of tested. practice in 7 CFR part 50, which are (a) For Pullorum-Typhoid. (1) The offi- hereby made applicable to proceedings cial blood tests for pullorum-typhoid before the Administrator under this shall be the standard tube agglutina- section. The definitions in 7 CFR 50.10 tion test, the microagglutination test, and the following definitions shall the enzyme-linked immunosorbent apply with respect to terms used in assay test (ELISA), or the rapid serum such rules of practice: test for all poultry; and the stained (a) Administrator means the Adminis- antigen, rapid whole-blood test for all trator, Animal and Plant Health In- poultry except turkeys. The procedures spection Service of the U.S. Depart- for conducting official blood tests are ment of Agriculture or any officer or set forth in §§ 147.1, 147.2, 147.3, and 147.5 employee to whom authority has here- of this chapter and referenced in foot- tofore been delegated or to whom au- note 3 of this section or in literature thority may hereafter be delegated to provided by the producer. Only anti- act in his stead. gens approved by the Department and of the polyvalent type shall be used for [36 FR 23112, Dec. 3, 1971, as amended at 38 the rapid whole-blood and tube aggluti- FR 3038, Feb. 1, 1973. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 47 FR nation tests. Each serial of tube anti- 21991, May 20, 1982; 67 FR 8468, Feb. 25, 2002] gen shall be submitted by the antigen producer to the Department for ap- § 145.14 Testing. proval upon manufacture and once a Poultry must be more than 4 months year thereafter as long as antigen from of age when tested for an official clas- that serial continues to be made avail- sification: Provided, That turkey can- able for use. All microtest antigens and didates under subpart D of this part enzyme-linked immunosorbent assay may be tested at more than 12 weeks of reagents shall also be approved by the 1 age; game bird candidates under sub- Department. part E of this part may be tested when (2) [Reserved] (3) There shall be an interval of at more than 4 months of age or upon least 21 days between any official blood reaching sexual maturity, whichever test and any previous test with pul- comes first; and ostrich, emu, rhea, and lorum-typhoid antigen. cassowary candidates under subpart F (4) [Reserved] of this part may be tested when more (5) The official blood test shall in- than 12 months of age. Samples for offi- clude the testing of a sample of blood cial tests shall be collected by an Au- from each bird in the flock: Provided, thorized Agent, Authorized Testing That under specified conditions (see Agent, or State Inspector and tested by applicable provisions of §§ 145.23, 145.33, an authorized laboratory, except that the stained antigen, rapid whole-blood test for pullorum-typhoid may be con- 1 The criteria and procedures for Depart- ducted by an Authorized Testing Agent ment approval of antigens and reagents may be obtained from the Animal and Plant or State Inspector. For Plan programs Health Inspection Service, Veterinary Serv- in which a representative sample may ices, Center for Veterinary Biologics, 510 be tested in lieu of an entire flock, ex- South 17th Street, Suite 104, Ames, IA 50010– cept the ostrich, emu, rhea, and casso- 8197.

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145.43, 145.53 and 145.63) the testing of a supplies that could be a source of pul- portion or sample of the birds may be lorum-typhoid spread are sanitized. used in lieu of testing each bird. (7) When S. pullorum or S. gallinarum (6) Poultry from flocks undergoing organisms are isolated by an author- qualification testing for participation ized laboratory from baby poultry, or in the Plan that have a positive reac- from fluff samples produced by hatch- tion to an official blood test named in ing eggs, the infected flock shall qual- paragraph (a)(1) of this section shall be ify for participation in the Plan with evaluated for pullorum-typhoid as fol- two consecutive negative results to an lows: official blood test named in paragraph (i) Serum samples that react on rapid (a)(1) of this section. A succeeding serum test or enzyme-labeled flock must be qualified for participa- immunosorbent assay test (ELISA), or tion in the Plan’s pullorum-typhoid blood from birds that react on the program with a negative result to an stained antigen, rapid whole-blood test official blood test named in paragraph for all birds except turkeys, shall be (a)(1) of this section. Testing to qualify tested with either the standard tube flocks for Plan participation must in- agglutination test or the microaggluti- clude the testing of all birds in infected nation test. flocks and succeeding flocks for a 12- (ii) Reactors to the standard tube ag- month period, and shall be performed glutination test (in dilutions of 1:50 or or physically supervised by a State In- greater) or the microagglutination test spector; Provided, That at the discre- (in dilutions of 1:40 or greater) shall be tion of the Official State Agency, a submitted to an authorized laboratory sample of at least 500 birds, rather than for bacteriological examination. If all birds in the flock, may be tested by there are more than four reactors in a the State Inspector if it is agreed upon flock, a minimum of four reactors shall by the Official State Agency, the be submitted to the authorized labora- flockowner, and the Administrator. If tory; if the flock has four or fewer re- the State Inspector determines that a actors, all of the reactors must be sub- primary breeding flock has been ex- 2 mitted. The approved procedure for posed to S. pullorum or S. gallinarum, bacteriological examination is set the Official State Agency shall require: forth in § 147.11 of this chapter. When (i) The taking of blood samples—per- reactors are submitted to the author- formed by or in the presence of a State ized laboratory within 10 days of the Inspector—from all birds on premises date of reading an official blood test exposed to birds, equipment, supplies, named in paragraph (a)(6)(i) of this sec- or personnel from the primary breeding tion, and the bacteriological examina- flock during the period when the State tion fails to demonstrate pullorum-ty- Inspector determined that exposure to 2 phoid infection, the Official State S. pullorum or S. gallinarum occurred. Agency shall presume that the flock (ii) The banding of all birds of these has no pullorum-typhoid reactors. premises—performed or physically su- (iii) If a flock owner does not wish to pervised by a State Inspector—in order submit reactors for bacteriological ex- to identify any bird that tests positive; amination, then the reactors shall be and isolated and retested within 30 days (iii) The testing of blood samples at using an official blood test named in an authorized laboratory using an offi- paragraph (a)(1) of this section. If this cial blood test named in paragraph retest is positive, additional examina- (a)(1) of this section. tion of the reactors and flock will be performed in accordance with para- 2 In making determinations of exposure, graph (a)(6)(ii) of this section. During the State Inspector shall evaluate both evi- this 30-day period, the flock must be dence proving that exposure occurred and maintained under a security system, circumstances indicating a high probability of contacts with: infected wild birds; con- specified or approved by the Official taminated feed or waste; or birds, equip- State Agency, that will prevent phys- ment, supplies, or persons from or exposed to ical contact with other birds and as- flocks infected with S. pullorum or S. sure that personnel, equipment, and gallinarum.

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(8) All domesticated fowl, except wa- tube agglutination test, the terfowl, on the farm of the participant hemagglutination inhibition (HI) test, shall either be properly tested to meet the microhemagglutination inhibition the same standards as the partici- test, the enzyme-linked pating flock or these birds and their immunosorbent assay (ELISA) test,3 a eggs shall be separated from the par- polymerase chain reaction (PCR)-based ticipating flock and its eggs. test, or a combination of two or more (9) All tests for pullorum-typhoid in of these tests. The HI test or the flocks participating in or candidates microhemagglutination inhibition test for participation in the Plan shall be shall be used to confirm the positive reported to the Official State Agency results of other serological tests. HI within 10 days following the comple- titers of 1:40 or more may be inter- tion of such tests. All reactors shall be preted as suspicious, and final judg- considered in determining the classi- ment must be based on further fication of the flock. samplings and/or culture of reactors. (10) Any drug, for which there is sci- (2) The serological tests shall be con- entific evidence of masking the test re- ducted using M. gallisepticum, M. action or hindering the bacteriological meleagridis, or M. synoviae antigens ap- recovery of Salmonella organisms, proved by the Department or the Offi- shall not be fed or administered to cial State Agency and shall be per- poultry within 3 weeks prior to a test formed in accordance with the rec- or bacteriological examination upon ommendations of the producer of the which a Salmonella classification is antigen. based. (3) When reactors to the test for (11) When suitable evidence, as deter- which the flock was tested are sub- mined by the Official State Agency or mitted to a laboratory as prescribed by the State Animal Disease Control Offi- cial, indicates that baby or started the Official State Agency, the criteria poultry produced by participating found in § 147.6 of this chapter shall be hatcheries are infected with organisms used in determining the final status of for which the parent flock received an the flock. official control classification and this (4) Any drug, for which there is sci- evidence indicates that the infection entific evidence of masking the test re- was transmitted from the parent flock, action or hindering the bacteriological the Official State Agency may, at its recovery of mycoplasma organisms, discretion, require additional testing of shall not be fed or administered to the flock involved. If infection is found poultry within three weeks prior to a in the parent flock, its classification test or bacteriological examination shall be suspended until the flock is re- upon which a Mycoplasma classifica- qualified under the requirements for tion is based. the classification. Furthermore, the Of- ficial State Agency may require that 3 Procedures for the enzyme-linked the hatching eggs from such flocks be immunosorbent assay (ELISA) test are set removed from the incubator and de- forth in the following publications: stroyed prior to hatching. When Sal- A.A. Ansari, R.F. Taylor, T.S. Chang, ‘‘Ap- monella organisms are isolated from a plication of Enzyme-Linked Immunosorbent Assay for Detecting Antibody to Myco- specimen which originated in a partici- plasma gallisepticum Infections in Poultry,’’ pating hatchery, the Official State Avian Diseases, Vol. 27, No. 1, pp. 21–35, Janu- Agency shall attempt to locate the ary–March 1983; and source of the infection. The results of H.M. Opitz, J.B. Duplessis, and M.J. Cyr, the investigation and the action taken ‘‘Indirect Micro-Enzyme-Linked to eliminate the infection shall be re- Immunosorbent Assay for the Detection of ported by the Official State Agency to Antibodies to Mycoplasma synoviae and M. the Service. gallisepticum,’’ Avian Diseases, Vol. 27, No. 3, (b) For Mycoplasma gallisepticum, M. pp. 773–786, July–September 1983; and H.B. Ortmayer and R. Yamamoto, ‘‘Myco- meleagridis, and M. synoviae. (1) The of- plasma Meleagridis Antibody Detection by ficial tests for M. gallisepticum, M. Enzyme-Linked Immunosorbent Assay meleagridis, and M. synoviae shall be the (ELISA),’’ Proceedings, 30th Western Poultry serum plate agglutination test, the Disease Conference, pp. 63–66, March 1981.

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(5) The official molecular examina- (B) Positive results from the RRT– tion procedures for M. gallisepticum are PCR must be further tested by Federal the PCR test described in § 147.30 of this Reference Laboratories using appro- subchapter and the real-time PCR test priate tests for confirmation. Final described in § 147.31 of this subchapter. judgment may be based upon further The official molecular examination sampling and appropriate tests for con- procedure for M. synoviae is the PCR firmation. test described in § 147.30 of this sub- (ii) USDA-licensed type A influenza chapter. antigen capture immunoassay (ACIA). (A) (c) [Reserved] The USDA-licensed type A influenza (d) For avian influenza. The official ACIA must be conducted using test tests for avian influenza are described kits approved by the Department and in paragraphs (d)(1) and (d)(2) of this the Official State Agency and must be section. conducted in accordance with the rec- (1) Antibody detection tests—(i) En- ommendations of the producer or man- zyme-linked immunosorbent assay ufacturer. (ELISA). ELISA must be conducted (B) Positive results from the ACIA using test kits approved by the Depart- must be further tested by Federal Ref- ment and the Official State Agency and erence Laboratories using appropriate must be conducted in accordance with tests for confirmation. Final judgment the recommendations of the producer may be based upon further sampling or manufacturer. and appropriate tests for confirmation. (ii) The agar gel immunodiffusion (3) The official determination of a (AGID) test. (A) The AGID test must be flock as positive for the H5 or H7 conducted on all ELISA-positive sam- subtypes of avian influenza may be ples. made only by NVSL. (B) The AGID test must be conducted (Approved by the Office of Management and using reagents approved by the Depart- Budget under control number 0579–0007) ment and the Official State Agency. [36 FR 23112, Dec. 3, 1971] (C) Standard test procedures for the AGID test for avian influenza are set EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 145.14, see the List of CFR forth in § 147.9 of this subchapter. The Sections Affected, which appears in the test can be conducted on egg yolk or Finding Aids section of the printed volume blood samples. and at www.fdsys.gov. (D) Positive tests for the AGID must be further tested by Federal Reference § 145.15 Diagnostic surveillance pro- Laboratories using appropriate tests gram for low pathogenic avian infor confirmation. Final judgment may fluenza. be based upon further sampling and ap- (a) The Official State Agency must propriate tests for confirmation. develop a diagnostic surveillance pro- (2) Agent detection tests. Agent detec- gram for H5/H7 low pathogenic avian tion tests may be used to detect influ- influenza for all poultry in the State. enza A matrix gene or protein but not The exact provisions of the program to determine hemagglutinin or are at the discretion of the States. The neuraminidase subtypes. Samples for Service will use the standards in para- agent detection testing should be col- graph (b) of this section in assessing in- lected from naturally occurring flock dividual State plans for adequacy, in- mortality or clinically ill birds. cluding the specific provisions that the (i) The real time reverse transcriptase/ State developed. The standards should polymerase chain reaction (RRT–PCR) be used by States in developing those assay. (A) The RRT–PCR tests must be plans. conducted using reagents approved by (b) Avian influenza must be a disease the Department and the Official State reportable to the responsible State au- Agency. The RRT–PCR must be con- thority (State veterinarian, etc.) by all ducted using the National Veterinary licensed veterinarians. To accomplish Services Laboratories (NVSL) official this, all laboratories (private, State, protocol for RRT–PCR (AVPR01510) and and university laboratories) that per- must be conducted by personnel who form diagnostic procedures on poultry have passed an NVSL proficiency test. must examine all submitted cases of

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unexplained respiratory disease, egg under the conditions prescribed in production drops, and mortality for § 145.5(a). avian influenza by both an approved se- (b) Hatching eggs produced by multi- rological test and an approved antigen plier breeding flocks shall be fumigated detection test. Memoranda of under- (see § 147.25 of this chapter) or other- standing or other means must be used wise sanitized. to establish testing and reporting cri- (c) Any nutritive material provided teria (including criteria that provide to chicks must be free of the avian for reporting H5 and H7 low pathogenic pathogens that are officially rep- avian influenza directly to the Service) resented in the Plan disease classifica- and approved testing methods. In additions listed in § 145.10. tion, States should conduct outreach to poultry producers, especially owners [36 FR 23112, Dec. 3, 1971, as amended at 40 of smaller flocks, regarding the impor- FR 1501, Jan. 8, 1975. Redesignated at 44 FR tance of prompt reporting of clinical 61586, Oct. 26, 1979, and amended at 49 FR symptoms consistent with avian influ- 19802, May 10, 1984; 57 FR 57341, Dec. 4, 1992; enza. 65 FR 8017, Feb. 17, 2000; 68 FR 64510, Nov. 14, 2003; 72 FR 1419, Jan. 12, 2007] [74 FR 14715, Apr. 1, 2009] § 145.23 Terminology and classifica- Subpart B—Special Provisions for tion; flocks and products. Multiplier Egg-Type Chicken Participating flocks, and the eggs Breeding Flocks and Prod- and chicks produced from them, which ucts have met the respective requirements specified in this section may be des- § 145.21 Definitions. ignated by the following terms and the corresponding designs illustrated in Except where the context otherwise requires, for the purposes of this sub- § 145.10: part the following terms shall be con- (a) [Reserved] strued, respectively, to mean: (b) U.S. Pullorum-Typhoid Clean. A Chicks. Newly hatched chickens. flock in which freedom from pullorum Egg type chicken breeding flocks. and typhoid has been demonstrated to Flocks that are composed of stock that the official State agency under the cri- has been developed for egg production teria in one of the following paragraphs and are maintained for the principal (b)(1) through (5) of this section: Pro- purpose of producing chicks for the ul- vided, That a flock qualifying by means timate production of eggs for human of a blood test shall be tested within consumption. the past 12 months, except that the re- Started chickens. Young chickens testing of a participating flock which (chicks, pullets, cockerels, capons) is retained for more than 12 months which have been fed and watered and shall be conducted a minimum of 4 are less than 6 months of age. weeks after the induction of molt. (See § 145.14 relating to the official blood [36 FR 23112, Dec. 3, 1971, as amended at 38 test where applicable.) FR 13707, May 24, 1973; 41 FR 48723, Nov. 5, 1976. Redesignated at 44 FR 61586, Oct. 26, (1) It has been officially blood tested 1979, and amended at 59 FR 12798, Mar. 18, with no reactors. 1994; 65 FR 8017, Feb. 17, 2000] (2) It is a multiplier breeding flock and meets the following specifications § 145.22 Participation. as determined by the Official State Participating flocks of multiplier egg Agency and the Service: type chickens, and the eggs and chicks (i) The flock is located in a State produced from them, shall comply with where all persons performing poultry the applicable general provisions of disease diagnostic services within the subpart A of this part and the special State are required to report to the Offi- provisions of this subpart B. cial State Agency within 48 hours the (a) Started chickens shall lose their source of all poultry specimens from identity under Plan terminology when which S. pullorum or S. gallinarum is not maintained by Plan participants isolated;

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(ii) The flock is composed entirely of (iv) All persons performing poultry birds that originated from U.S. Pul- disease diagnostic services within the lorum-Typhoid Clean breeding flocks State are required to report to the Offi- or from flocks that met equivalent re- cial State Agency within 48 hours the quirements under official supervision; source of all poultry specimens from and which S. pullorum or S. gallinarum is (iii) The flock is located on a prem- isolated; ises where a flock not classified as U.S. (v) All reports of any disease out- Pullorum-Typhoid Clean was located break involving a disease covered the previous year; Provided, That an under the Plan are promptly followed Authorized Testing Agent must blood by an investigation by the Official test up to 300 birds per flock, as de- State Agency to determine the origin scribed in § 145.14, if the Official State of the infection; Provided, That if the Agency determines that the flock has origin of the infection involves another been exposed to pullorum-typhoid. In State, or if there is exposure to poultry making determinations of exposure and in another State from the infected setting the number of birds to be blood flock, then the National Poultry Im- tested, the Official State Agency shall provement Plan will conduct an inves- evaluate the results of any blood tests, tigation; described in § 145.14(a)(1) that were per- (vi) All flocks found to be infected formed on an unclassified flock located with pullorum or typhoid are quar- on the premises during the previous antined until marketed or destroyed year; the origins of the unclassified under the supervision of the Official flock; and the probability of contacts State Agency, or until subsequently between the flock for which qualifica- blood tested, following the procedure tion is being sought and (a) infected for reacting flocks as contained in wild birds, (b) contaminated feed or § 145.14(a)(5), and all birds fail to dem- waste, or (c) birds, equipment, supplies, onstrate pullorum or typhoid infection; or personnel from flocks infected with (vii) All poultry, including exhi- pullorum-typhoid. bition, exotic, and game birds, but excluding waterfowl, going to public ex- (3) It is a multiplier breeding flock hibition shall come from U.S. Pul- that originated from U.S. Pullorum- lorum-Typhoid Clean or equivalent Typhoid Clean breeding flocks or from flocks, or have had a negative pul- flocks that met equivalent require- lorum-typhoid test within 90 days of ments under official supervision, and is going to public exhibition; located in a State in which it has been (viii) Discontinuation of any of the determined by the Service that: conditions or procedures described in (i) All hatcheries within the State paragraphs (b)(3)(i), (ii), (iii), (iv), (v), are qualified as ‘‘National Plan Hatch- (vi), and (vii) of this section, or the oc- eries’’ or have met equivalent require- currence of repeated outbreaks of pul- ments for pullorum-typhoid control lorum or typhoid in poultry breeding under official supervision; flocks within or originating within the (ii) All hatchery supply flocks within State shall be grounds for the Service the State, are qualified as U.S. Pul- to revoke its determination that such lorum-Typhoid Clean or have met conditions and procedures have been equivalent requirements for pullorum- met or complied with. Such action typhoid control under official super- shall not be taken until a thorough in- vision: Provided, That if other domes- vestigation has been made by the Serv- ticated fowl, except waterfowl, are ice and the Official State Agency has maintained on the same premises as been given an opportunity to present the participating flock, freedom from its views. pullorum-typhoid infection shall be (4) It is a multiplier breeding flock demonstrated by an official blood test located in a State which has been de- of each of these fowl; termined by the Service to be in com- (iii) All shipments of products other pliance with the provisions of (b)(3) of than U.S. Pullorum-Typhoid Clean, or this section, and in which pullorum equivalent, into the State are prohib- disease or fowl typhoid is not known to ited; exist nor to have existed in hatchery

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supply flocks within the State during met the following requirements as de- the preceding 12 months. termined by the Official State Agency: (c) U.S. M. Gallisepticum Clean. (1) A (i) The flock originated from a U.S. S. flock maintained in compliance with enteritidis Clean flock, or meconium the provisions of § 147.26 of this chapter from the chick boxes and a sample of and in which freedom from M. chicks that died within 7 days after gallisepticum has been demonstrated hatching are examined bacterio- under the criteria specified in para- logically for salmonella at an author- graph (c)(1)(i) or (ii) of this section. ized laboratory. Cultures from positive (i) [Reserved] samples shall be serotyped. (ii) It is a multiplier breeding flock (ii) All feed fed to the flock shall which originated as U.S. M. meet the following requirements: Gallisepticum Clean chicks from pri- (A) Pelletized feed shall contain ei- mary breeding flocks and from which a ther no animal protein or only animal sample comprised of a minimum of 150 protein products produced under the birds per flock has been tested for M. Animal Protein Products Industry gallisepticum as provided in § 145.14(b) (APPI) Salmonella Education/Reduction when more than 4 months of age: Pro- Program. The protein products must vided, That to retain this classifica- have a minimum moisture content of tion, the flock shall be subjected to one of the following procedures: 14.5 percent and must have been heated throughout to a minimum temperature (A) At intervals of not more than 90 ° days, 75 birds from the flock shall be of 190 F., or above, or to a minimum ° tested, Provided, that fewer than 75 temperature of 165 F. for at least 20 birds from the flock may be tested at minutes, or to a minimum temperature any one time if all pens are equally of 184 °F. under 70 lbs. pressure during represented and a total of at least 75 the manufacturing process. birds from the flock is tested within (B) Mash feed may contain no animal each 90-day period; or protein other than an APPI animal (B) At intervals of not more than 30 protein product supplement manufac- days, a sample of 25 cull chicks pro- tured in pellet form and crumbled: Pro- duced from the flock shall be subjected vided, that mash feed may contain to laboratory procedures acceptable to nonpelleted APPI animal protein prod- the Official State Agency and approved uct supplements if the finished feed is by the Service, for the detection and treated with a salmonella control prod- recovery of M. gallisepticum; or uct approved by the Food and Drug Ad- (C) At intervals of not more than 30 ministration. days, egg yolk testing shall be con- (iii) Feed shall be stored and trans- ducted in accordance with § 147.8 of this ported in such a manner as to prevent chapter. possible contamination; (2) A participant handling U.S. M. (iv) The flock is maintained in com- Gallisepticum Clean products shall pliance with §§ 147.21, 147.24(a), and keep these products separate from 147.26 of this chapter. Rodents and other products in a manner satisfac- other pests should be effectively con- tory to the Official State Agency. trolled; (3) U.S. M. Gallisepticum Clean (v) Environmental samples shall be chicks shall be boxed in clean boxes collected from the flock by an Author- and delivered in trucks that have been ized Agent, as described in § 147.12 of cleaned and disinfected as described in § 147.24(a) of this chapter. this chapter, when the flock is 2 to 4 weeks of age. The samples shall be ex- (d) U.S. S. Enteritidis Clean. This classification is intended for egg-type amined bacteriologically for group D breeders wishing to assure their cus- salmonella at an authorized labora- tomers that the hatching eggs and tory. Cultures from positive samples chicks produced are certified free of shall be serotyped. The authorized Salmonella enteritidis. agent shall also collect samples every (1) A flock and the hatching eggs and 30 days after the first sample has been chicks produced from it which have collected.

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(vi) If a Salmonella vaccine is used more, or 30 live birds from a flock with that causes positive reactions with pul- fewer than 5,000 birds. If only one speci- lorum-typhoid antigen, one of the fol- men is found positive for SE, the par- lowing options must be utilized: ticipant may request bacteriological (A) Administer the vaccine after the examination of a second sample, equal pullorum-typhoid testing is done as de- in size to the first sample, from the scribed in paragraph (d)(1)(vii) of this flock. If no SE is recovered from any of section. the specimens in the second sample, (B) If an injectable bacterin or live the flock will be eligible for the classi- vaccine that does not spread is used, fication. keep a sample of 350 birds unvaccinated (3) A non-vaccinated flock shall be el- and banded for identification until the igible for this classification if Sal- flock reaches at least 4 months of age. Following negative serological and monella enteritidis (S. enteritidis ser bacteriological examinations as de- Enteritidis) is isolated from an envi- scribed in paragraph (d)(1)(vii) of this ronmental sample collected from the section, vaccinate the banded, non-vac- flock in accordance with paragraph cinated birds. (d)(1)(v) of this section: Provided, That (vii) Blood samples from 300 non-vac- testing is conducted in accordance with cinated birds as described in paragraph paragraph (d)(1)(vii) of this section (d)(1)(vi) of this section shall be tested each 30 days and no positive samples with either pullorum antigen or by a are found. federally licensed Salmonella (4) In order for a hatchery to sell enteritidis enzyme-linked products of this classification, all prod- immunosorbent assay (ELISA) test ucts handled shall meet the require- when the flock is more than 4 months ments of the classification. of age. All birds with positive or incon- (5) This classification may be re- clusive reactions, up to a maximum of voked by the Official State Agency if 25 birds, shall be submitted to an au- the participant fails to follow rec- thorized laboratory and examined for ommended corrective measures. the presence of group D salmonella, as (e) U.S.M. Synoviae Clean. (1) A flock described in § 147.11 of this chapter. maintained in compliance with the Cultures from positive samples shall be provisions of § 147.26 of this chapter and serotyped. (viii) Hatching eggs are collected as in which freedom from M. synoviae has quickly as possible and are handled as been demonstrated under the criteria described in § 147.22 of this chapter and specified in paragraph (e)(1)(i) or (ii) of are sanitized or fumigated (see § 147.25 this section. of this chapter). (i) [Reserved] (ix) Hatching eggs produced by the (ii) It is a multiplier breeding flock flock are incubated in a hatchery that which originated as U.S. M. Synoviae is in compliance with the recommenda- Clean chicks from primary breeding tions in §§ 147.23 and 147.24(b) of this flocks and from which a sample com- chapter, and sanitized either by a pro- prised of a minimum of 150 birds has cedure approved by the Official State been tested for M. synoviae as provided Agency or fumigated (see § 147.25 of this in § 145.14(b) when more than 4 months chapter). of age: Provided, That to retain this (2) A flock shall not be eligible for classification, the flock shall be sub- this classification if Salmonella jected to one of the following proce- enteritidis ser enteritidis (SE) is isolated dures: from a specimen taken from a bird in (A) At intervals of not more than 90 the flock. Isolation of SE from an envi- days, 75 birds from the flock shall be ronmental or other specimen, as de- tested: Provided, That fewer than 75 scribed in paragraph (d)(1)(v) of this section, will require bacteriological ex- birds from the flock may be tested at amination for SE in an authorized lab- any one time if all pens are equally oratory, as described in § 147.11(a) of represented and a total of at least 75 this chapter, of a random sample of 60 birds from the flock is tested within live birds from a flock of 5,000 birds or each 90-day period; or

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(B) At intervals of not more than 30 15–20 days prior to the flock being days, egg yolk testing shall be con- moved to laying quarters. ducted in accordance with § 147.8 of this (5) Started poultry shall be delivered chapter. to and from the farm premises in (2) A participant handling U.S. M. crates and vehicles which have been Synoviae Clean products shall keep cleaned and disinfected as described in these products separate from other § 147.24(a) of this chapter. products in a manner satisfactory to (h) U.S. Avian Influenza Clean. This the Official State Agency. program is intended to be the basis (3) U.S. M. Synoviae Clean chicks from which the breeding-hatchery in- shall be boxed in clean boxes and deliv- dustry may conduct a program for the ered in trucks that have been cleaned prevention and control of avian influ- and disinfected as described in enza. It is intended to determine the § 147.24(a) of this chapter. presence of avian influenza in breeding (f) U.S. M. Gallisepticum Clean Started chickens through routine surveillance Poultry. (1) A flock which originated of each participating breeding flock. A from U.S. M. Gallisepticum Clean flock and the hatching eggs and chicks breeding flocks and was hatched in a produced from it will qualify for this hatchery approved by the Official State Agency for the production of U.S. M. classification when the Official State Gallisepticum Clean chicks. Agency determines that they have met (2) All other poultry on the premises the following requirements: of the candidate flock must originate (1) It is a multiplier breeding flock in from U.S. M. Gallisepticum Clean which a minimum of 30 birds have been sources. tested negative for antibodies to avian (3) The flock is maintained in compli- influenza when more than 4 months of ance with the provisions of § 147.26 of age. To retain this classification: this chapter. (i) A sample of at least 30 birds must (4) The flock’s freedom from M. be tested negative at intervals of 90 Gallisepticum is demonstrated by a neg- days; or ative blood test, as provided in (ii) A sample of fewer than 30 birds § 145.14(b), of a sample of 75 birds, with may be tested, and found to be nega- a minimum of 50 birds per poultry tive, at any one time if all pens are house, between 15–20 days prior to the equally represented and a total of 30 flock being moved to laying quarters. birds is tested within each 90-day pe- (5) Started poultry shall be delivered riod; or to and from the farm premises in (iii) The flock is tested as provided in crates and vehicles which have been § 145.14(d) at intervals of 30 days or less cleaned and disinfected as described in and found to be negative, and a total of § 147.24(a) of this chapter. 30 samples are collected and tested (g) U.S. M. Synoviae Clean Started within each 90-day period; and Poultry. (1) A flock which originated (2) During each 90-day period, all from U.S. M. Synoviae Clean breeding multiplier spent fowl, up to a max- flocks and was hatched in a hatchery imum of 30, must be tested and found approved by the Official State Agency negative within 21 days prior to move- for production of U.S. M. Synoviae ment to slaughter. Clean chicks. (2) All other poultry on the premises (Approved by the Office of Management and of the candidate flock must originate Budget under control number 0579–0007) from U.S. M. Synoviae Clean sources. [36 FR 23112, Dec. 3, 1971] (3) The flock is maintained in compliance with the provisions of § 147.26 of EDITORIAL NOTE: For FEDERAL REGISTER ci- this chapter. tations affecting § 145.23, see the List of CFR Sections Affected, which appears in the (4) The flocks’s freedom from M. Finding Aids section of the printed volume synoviae is demonstrated by a negative and at www.fdsys.gov. blood test, as provided in § 145.14(b), of a sample of 75 birds, with a minimum of 50 birds per poultry house, between

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§ 145.24 Terminology and classifica- Chicks. Newly hatched chickens. tion; States. Meat type chicken breeding flocks. (a) U.S. Pullorum-Typhoid Clean State. Flocks that are composed of stock that (1) A State will be declared a U.S. Pul- has been developed for meat production lorum-Typhoid Clean State when it has and are maintained for the principal been determined by the Service that: purpose of producing chicks for the ul- (i) The State is in compliance with timate production of meat. the provisions contained in Started chickens. Young chickens § 145.23(b)(3)(i) through (vii), (chicks, pullets, cockerels, capons) § 145.33(b)(3)(i) through (vii), which have been fed and watered and § 145.43(b)(3)(i) through (vi), are less than 6 months of age. § 145.53(b)(3)(i) through (vii), [36 FR 23112, Dec. 3, 1971, as amended at 41 § 145.73(b)(2)(i), § 145.83(b)(2)(i), and FR 48724, Nov. 5, 1976. Redesignated at 44 FR § 145.93(b)(3)(i) through (vii). 61586, Oct. 26, 1979, and amended at 59 FR (ii) No pullorum disease or fowl ty- 12799, Mar. 18, 1994; 65 FR 8018, Feb. 17, 2000] phoid is known to exist nor to have existed in hatchery supply flocks within § 145.32 Participation. the State during the preceding 12 Participating flocks of multiplier months: Provided, That pullorum dis- meat type chickens, and the eggs and ease or fowl typhoid found within the chicks produced from them, shall com- preceding 24 months in waterfowl, exhi- ply with the applicable general provi- bition poultry, and game bird breeding sions of subpart A of this part and the flocks will not prevent a State, which special provisions of this subpart C. is otherwise eligible, from qualifying. (a) Started chickens shall lose their (2) Discontinuation of any of the con- identity under Plan terminology when ditions described in paragraph (a)(1)(i) not maintained by Plan participants of this section, or repeated outbreaks under the conditions prescribed in of pullorum or typhoid occur in hatch- § 145.5(a). ery supply flocks described in para- (b) Hatching eggs produced by multi- graph (a)(1)(ii) of this section, or if an plier breeding flocks shall be fumigated infection spreads from the originating (see § 147.25 of this chapter) or other- premises, the Service shall have wise sanitized. grounds to revoke its determination (c) Any nutritive material provided that the State is entitled to this classi- to chicks must be free of the avian fication. Such action shall not be pathogens that are officially rep- taken until a thorough investigation resented in the Plan disease classifica- has been made by the Service and the tions listed in § 145.10. Official State Agency has been given an opportunity for a hearing in accord- [36 FR 23112, Dec. 3, 1971, as amended at 40 ance with rules of practice adopted by FR 1502, Jan. 8, 1975; 41 FR 48724, Nov. 5, 1976. the Administrator. Redesignated at 44 FR 61586, Oct. 26, 1979, and (b) [Reserved] amended at 49 FR 19802, May 10, 1984; 57 FR 57341, Dec. 4, 1992; 65 FR 8018, Feb. 17, 2000; 68 [40 FR 1502, Jan. 8, 1975. Redesignated at 44 FR 64510, Nov. 14, 2003; 72 FR 1419, Jan. 12, FR 61586, Oct. 26, 1979, and amended at 54 FR 2007] 23957, June 5, 1989; 67 FR 8469, Feb. 25, 2002; 72 FR 1419, Jan. 12, 2007; 76 FR 15793, Mar. 22, § 145.33 Terminology and classifica- 2011] tion; flocks and products. Participating flocks, and the eggs Subpart C—Special Provisions for and chicks produced from them, which Multiplier Meat-Type Chicken have met the respective requirements Breeding Flocks and Prod- specified in this section may be des- ucts ignated by the following terms and the corresponding designs illustrated in § 145.31 Definitions. § 145.10: Except where the context otherwise (a) [Reserved] requires, for the purposes of this sub- (b) U.S. Pullorum-Typhoid Clean. A part the following terms shall be con- flock in which freedom from pullorum strued, respectively, to mean: and typhoid has been demonstrated to

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the official State agency under the cri- flocks that met equivalent require- teria in one of paragraphs (b)(1) ments under official supervision, and is through (5) of this section: Provided, located in a State in which it has been That a flock qualifying by means of a determined by the Service that: blood test shall be tested within the (i) All hatcheries within the State past 12 months, except that the re- are qualified as ‘‘National Plan Hatch- testing of a participating flock which eries’’ or have met equivalent require- is retained for more than 12 months ments for pullorum-typhoid control shall be conducted a minimum of 4 under official supervision; weeks after the induction of molt. (See (ii) All hatchery supply flocks within § 145.14 relating to the official blood the State, are qualified as U.S. Pul- test where applicable.) lorum-Typhoid Clean or have met (1) It has been officially blood tested equivalent requirements for pullorum- with no reactors. typhoid control under official super- (2) It is a multiplier breeding flock vision: Provided, That if other domes- and meets the following specifications ticated fowl, except waterfowl, are as determined by the Official State maintained on the same premises as Agency and the Service: the participating flock, freedom from (i) The flock is located in a State pullorum-typhoid infection shall be where all persons performing poultry demonstrated by an official blood test disease diagnostic services within the of each of these fowl; State are required to report to the Offi- (iii) All shipments of products other cial State Agency within 48 hours the than U.S. Pullorum-Typhoid Clean, or source of all poultry specimens from equivalent, into the State are prohib- which S. pullorum or S. gallinarum is ited; isolated; (ii) The flock is composed entirely of (iv) All persons performing poultry birds that originated from U.S. Pul- disease diagnostic services within the lorum-Typhoid Clean breeding flocks State are required to report to the Offi- or from flocks that met equivalent re- cial State Agency within 48 hours the quirements under official supervision; source of all poultry specimens from and which S. pullorum or S. gallinarum is (iii) The flock is located on a prem- isolated; ises where a flock not classified as U.S. (v) All reports of any disease out- Pullorum-Typhoid Clean was located break involving a disease covered the previous year; Provided, That an under the Plan are promptly followed Authorized Testing Agent must blood by an investigation by the Official test up to 300 birds per flock, as de- State Agency to determine the origin scribed in § 145.14, if the Official State of the infection; Provided, That if the Agency determines that the flock has origin of the infection involves another been exposed to pullorum-typhoid. In State, or if there is exposure to poultry making determinations of exposure and in another State from the infected setting the number of birds to be blood flock, then the National Poultry Im- tested, the Official State Agency shall provement Plan will conduct an inves- evaluate the results of any blood tests, tigation; described in § 145.14(a)(1), that were per- (vi) All flocks found to be infected formed on an unclassified flock located with pullorum or typhoid are quar- on the premises during the previous antined until marketed or destroyed year; the origins of the unclassified under the supervision of the Official flock; and the probability of contacts State Agency, or until subsequently between the flock for which qualifica- blood tested following the procedure tion is being sought and (a) infected for reacting flocks as contained in wild birds, (b) contaminated feed or § 145.14(a)(5), and all birds fail to dem- waste, or (c) birds, equipment, supplies, onstrate pullorum or typhoid infection; or personnel from flocks infected with (vii) All poultry, including exhi- pullorum-typhoid. bition, exotic, and game birds, but ex- (3) It is a multiplier breeding flock cluding waterfowl, going to public ex- that originated from U.S. Pullorum- hibition shall come from U.S. Pul- Typhoid Clean breeding flocks or from lorum-Typhoid Clean or equivalent

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flocks, or have had a negative pul- to laboratory procedures acceptable to lorum-typhoid test within 90 days of the Official State Agency and approved going to public exhibition; by the Service, for the detection and (viii) Discontinuation of any of the recovery of M. gallisepticum; or conditions or procedures described in (C) At intervals of not more than 30 paragraphs (b)(3)(i), (ii), (iii), (iv), (v), days, egg yolk testing shall be con- (vi), and (vii) of this section, or the oc- ducted in accordance with § 147.8 of this currence of repeated outbreaks of pul- chapter. lorum or typhoid in poultry breeding (2) A participant handling U.S. M. flocks within or originating within the Gallisepticum Clean products must State shall be grounds for the Service keep these products separate from to revoke its determination that such other products through the use of sepa- conditions and procedures have been rate hatchers and incubators, separate met or complied with. Such action hatch days, and proper hatchery sani- shall not be taken until a thorough in- tation and biosecurity (see §§ 147.22, vestigation has been made by the Serv- 147.23, and 147.24) in a manner satisfac- ice and the Official State Agency has tory to the Official State Agency. been given an opportunity to present (3) U.S. M. Gallisepticum Clean its views. chicks shall be boxed in clean boxes (4) It is a multiplier breeding flock and delivered in trucks that have been located in a State which has been de- cleaned and disinfected as described in termined by the Service to be in com- § 147.24(a) of this chapter. pliance with the provisions of para- (4) Before male breeding birds may be graph (b)(3) of this section, and in added to a participating multiplier which pullorum disease or fowl typhoid breeding flock, a sample of at least 30 is not known to exist nor to have ex- birds to be added, with a minimum of isted in hatchery supply flocks within 10 birds per pen, shall be tested for M. the State during the preceding 12 gallisepticum as provided in § 145.14(b), months. or by a polymerase chain reaction (c) U.S. M. Gallisepticum Clean. (1) A (PCR)-based procedure approved by the flock maintained in compliance with Department. If fewer than 30 male the provisions of § 147.26 of this chapter breeding birds are being added, all the and in which freedom from M. birds shall be tested as described above. gallisepticum has been demonstrated The male birds shall be tested no more under the criteria specified in para- than 14 days prior to their intended in- graph (c)(1)(i) or (ii) of this section. troduction into the flock. If the sero- (i) [Reserved] logic testing of the birds yields (ii) It is a multiplier breeding flock hemagglutination inhibition titers of which originated as U.S. M. 1:40 or higher as provided in § 145.14(b), Gallisepticum Clean chicks from pri- or if the PCR testing is positive for M. mary breeding flocks and from which a gallisepticum, the male birds may not be sample comprised of a minimum of 150 added to the flock and must be either birds per flock has been tested for M. retested or destroyed. gallisepticum as provided in § 145.14(b) (d) U.S. Sanitation Monitored. This when more than 4 months of age: Pro- program is intended to be the basis vided, That to retain this classifica- from which the breeding-hatching in- tion, the flock shall be subjected to one dustry may conduct a program for the of the following procedures: prevention and control of Salmonel- (A) At intervals of not more than 90 losis. It is intended to reduce the inci- days, 75 birds from the flock shall be dence of Salmonella organisms in tested, Provided, That fewer than 75 hatching eggs and chicks through an birds from the flock may be tested at effective and practical sanitation pro- any one time if all pens are equally gram at the breeder farm and in the represented and a total of at least 75 hatchery. This will afford other seg- birds from the flock is tested within ments of the poultry industry an op- each 90-day period; or portunity to reduce the incidence of (B) At intervals of not more than 30 Salmonella in their products. days, a sample of 25 cull chicks pro- (1) A flock and the hatching eggs and duced from the flock shall be subjected chicks produced from it which have

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met the following requirements as de- (3) In order for a hatchery to sell termined by the Official State Agency: products of this classification, all prod- (i) The flock shall originate from a ucts handled shall meet the require- source where sanitation and managements of the classification. ment practices, as outlined in (4) This classification may be re- § 145.33(d)(1) of this paragraph, are con- voked by the Official State Agency if ducted; the participant fails to follow rec- (ii) The flock is maintained in com- ommended corrective measures. pliance with §§ 147.21, 147.24(a), and (e) U.S. M. Synoviae Clean. (1) A flock 147.26 of this chapter; maintained in compliance with the (iii) If pelletized feed contains animal provisions of § 147.26 of this chapter and protein, the protein products shall be in which freedom from M. synoviae has purchased from participants in the been demonstrated under the criteria Animal Protein Products Industry specified in paragraph (e)(1)(i) or (ii) of (APPI) Salmonella Education/Reduction this section. Program or the Fishmeal Inspection (i) [Reserved] Program of the National Marine Fish- (ii) It is a multiplier breeding flock eries Service. The protein products which originated as U.S. M. Synoviae must have a minimum moisture con- Clean chicks from primary breeding tent of 14.5 percent and must have been flocks and from which a sample com- heated throughout to a minimum tem- prised of a minimum of 150 birds has perature of 190 °F. or above, or to a been tested for M. synoviae as provided minimum temperature of 165 °F. for at in § 145.14(b) when more than 4 months least 20 minutes, or to a minimum tem- of age: Provided, That to retain this perature of 184 °F. under 70 lbs. pres- classification, the flock shall be sub- sure during the manufacturing process; jected to one of the following proce- (iv) If mash feed contains animal pro- dures: tein, the protein products shall be pur- (A) At intervals of not more than 90 chased from participants in the Animal days, 75 birds from the flock shall be Protein Products Industry (APPI) Sal- tested: Provided, That fewer than 75 monella Education/Reduction Program birds from the flock may be tested at or the Fishmeal Inspection Program of any one time if all pens are equally the National Marine Fisheries Service; represented and a total of at least 75 (v) Feed shall be stored and trans- birds from the flock is tested within ported in such a manner as to prevent each 90-day period; or possible contamination; (B) At intervals of not more than 30 (vi) Chicks shall be hatched in a days, egg yolk testing shall be con- hatchery meeting the requirements of ducted in accordance with § 147.8 of this §§ 147.23 and 147.24(b) of this chapter and chapter. sanitized or fumigated (see § 147.25 of (2) A participant handling U.S. M. this chapter); Synoviae Clean products shall keep (vii) An Authorized Agent shall take these products separate from other environmental samples, as described in products in a manner satisfactory to § 147.12 of this chapter, from each flock the official State Agency. at 4 months of age and every 90 days (3) U.S. M. Synoviae Clean chicks thereafter. An authorized laboratory shall be boxed in clean boxes and deliv- for Salmonella shall examine the envi- ered in trucks that have been cleaned ronmental samples bacteriologically; and disinfected as described in (viii) Owners of flocks found infected § 147.24(a) of this chapter. with a paratyphoid Salmonella may vac- (4) Before male breeding birds may be cinate these flocks with an autogenous added to a participating multiplier bacterin with a potentiating agent. 4 breeding flock, a sample of at least 30 (2) The Official State Agency may birds to be added, with a minimum of use the procedures described in § 147.14 10 birds per pen, shall be tested for M. of this chapter to monitor the effec- synoviae as provided in § 145.14(b) or by tiveness of the sanitation practices. a polymerase chain reaction (PCR)- based procedure approved by the De- 4 Preparation and use of this type of vac- partment. If fewer than 30 male breed- cine may be regulated by State statutes. ing birds are being added, all the birds

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shall be tested as described above. The crates and vehicles which have been male birds shall be tested no more than cleaned and disinfected as described in 14 days prior to their intended intro- § 147.24(a) of this chapter. duction into the flock. If the serologic (h)–(i) [Reserved] testing of the birds yields (j) U.S. M. Gallisepticum Monitored. (1) hemagglutination inhibition titers of A multiplier breeding flock in which 1:40 or higher as provided in § 145.14(b), all birds or a sample of at least 30 birds or if the PCR testing is positive for M. per house has been tested for M. synoviae, the male birds may not be gallisepticum as provided in § 145.14(b) added to the flock and must be either when more than 4 months of age: Pro- retested or destroyed. vided, That to retain this classifica- (f) U.S. M. Gallisepticum Clean Started tion, a minimum of 30 birds per house Poultry. (1) A flock which originated shall be tested again at 36 to 38 weeks from U.S. M. Gallisepticum Clean and at 48 to 50 weeks at a minimum: breeding flocks and was hatched in a And provided further, That each 30-bird hatchery approved by the Official State sample should come from 2 locations Agency for the production of U.S. M. within the house (15 from the front half Gallisepticum Clean chicks. of the house and 15 from the back half (2) All other poultry on the premises of the house). A representative sample of the candidate flock must originate of males and females should be sam- from U.S. M. Gallisepticum Clean pled. The samples shall be marked sources. ‘‘male’’ or ‘‘female.’’ (3) The flock is maintained in compli- (2) A participant handling U.S. M. ance with the provisions of § 147.26 of Gallisepticum Monitored products this chapter. shall keep these products separate (4) The flock’s freedom from M. from other products in a manner satis- gallisepticum is demonstrated by a neg- factory to the Official State Agency: ative blood test, as provided in Provided, That U.S. M. Gallisepticum § 145.14(b), of a sample of 75 birds, with Monitored chicks from multiplier a minimum of 50 birds per poultry breeding flocks shall be produced in in- house, between 15–20 days prior to the cubators and hatchers in which only flock being moved to laying quarters. eggs from flocks qualified under para- (5) Started poultry shall be delivered graph (j)(1) of this section are set. Eggs to and from the farm premises in from U.S. M. Gallisepticum Monitored crates and vehicles which have been multiplier breeding flocks shall not be cleaned and disinfected as described in set in hatchers or incubators in which § 147.24(a) of this chapter. eggs from U.S. M. Gallisepticum Clean (g) U.S. M. Synoviae Clean Started primary breeding flocks qualified Poultry. (1) A flock which originated under paragraph (c)(1)(i) of this section from U.S. M. Synoviae Clean breeding are set. flocks and was hatched in a hatchery (3) U.S. M. Gallisepticum Monitored approved by the Official State Agency chicks shall be boxed in clean boxes for the production of U.S. M. Synoviae and delivered in trucks that have been Clean chicks. cleaned and disinfected as described in (2) All other poultry on the premises § 147.24(a) of this chapter. of the candidate flock must originate (k) U.S. M. Synoviae Monitored. (1) A from U.S. M. Synoviae Clean sources. multiplier breeding flock in which all (3) The flock is maintained in compli- birds or a sample of at least 30 birds ance with the provisions of § 147.26 of per house has been tested for M. this chapter. synoviae as provided in § 145.14(b) when (4) The flock’s freedom from M. more than 4 months of age: Provided, synoviae is demonstrated by a negative That to retain this classification, a blood test, as provided in § 145.14(b), of minimum of 30 birds per house shall be a sample of 75 birds, with a minimum tested again at 36 to 38 weeks and at 48 of 50 birds per poultry house, between to 50 weeks at a minimum: And pro- 15–20 days prior to the flock being vided further, That each 30-bird sample moved to laying quarters. should come from 2 locations within (5) Started poultry shall be delivered the house (15 from the front half of the to and from the farm premises in house and 15 from the back half of the

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house). A representative sample of 15 samples are collected and tested males and females should be sampled. within each 90-day period; and The samples shall be marked ‘‘male’’ or (2) During each 90-day period, all ‘‘female.’’ multiplier spent fowl, up to a max- (2) A participant handling U.S. M. imum of 30, must be tested and found Synoviae Monitored products shall negative within 21 days prior to move- keep these products separate from ment to slaughter. other products in a manner satisfac- (Approved by the Office of Management and tory to the Official State Agency: Pro- Budget under control number 0579–0007) vided, That U.S. M. Synoviae Mon- [36 FR 23112, Dec. 3, 1971] itored chicks from multiplier breeding flocks shall be produced in incubators EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 145.33, see the List of CFR and hatchers in which only eggs from Sections Affected, which appears in the flocks qualified under paragraph (k)(1) Finding Aids section of the printed volume of this section are set. Eggs from U.S. and at www.fdsys.gov. M. Synoviae Monitored multiplier breeding flocks shall not be set in § 145.34 Terminology and classifica- hatchers or incubators in which eggs tion; States. from U.S. M. Synoviae Clean primary (a) U.S. Pullorum-Typhoid-Clean State. breeding flocks qualified under para- (1) A State will be declared a U.S. Pul- graph (e)(1)(i) of this section are set. lorum-Typhoid Clean State when it has (3) U.S. M. Synoviae Monitored been determined by the Service that: chicks shall be boxed in clean boxes (i) The State is in compliance with and delivered in trucks that have been the provisions contained in cleaned and disinfected as described in § 145.23(b)(3)(i) through (vii), § 147.24(a) of this chapter. § 145.33(b)(3)(i) through (vii), (l) U.S. Avian Influenza Clean. This § 145.43(b)(3)(i) through (vi), program is intended to be the basis § 145.53(b)(3)(i) through (vii), from which the breeding-hatchery in- § 145.73(b)(2)(i), § 145.83(b)(2)(i), and dustry may conduct a program for the § 145.93(b)(3)(i) through (vii). prevention and control of avian influ- (ii) No pullorum disease or fowl typhoid is known to exist nor to have ex- enza. It is intended to determine the isted in hatchery supply flocks within presence of avian influenza in primary the State during the preceding 12 breeding chickens through routine sur- months: Provided, That pullorum dis- veillance of each participating breed- ease or fowl typhoid found within the ing flock. A flock and the hatching preceding 24 months in waterfowl, exhi- eggs and chicks produced from it will bition poultry, and game bird breeding qualify for this classification when the flocks will not prevent a State, which Official State Agency determines that is otherwise eligible from qualifying. they have met the following require- (2) Discontinuation of any of the con- ments: ditions described in paragraph (a)(1)(i) (1) It is a multiplier breeding flock in of this section, or repeated outbreaks which a minimum of 30 birds have been of pullorum or typhoid occur in hatch- tested negative for antibodies to avian ery supply flocks described in parainfluenza when more than 4 months of graph (a)(1)(ii) of this section, or if an age. To retain this classification: infection spreads from the originating (i) A sample of at least 15 birds must premises, the Service shall have be tested negative at intervals of 90 grounds to revoke its determination days; or that the State is entitled to this classi- (ii) A sample of fewer than 15 birds fication. Such action shall not be may be tested, and found to be nega- taken until a thorough investigation tive, at any one time if all pens are has been made by the Service and the equally represented and a total of 30 Official State Agency has been given birds is tested within each 90-day pe- an opportunity for a hearing in accord- riod; or ance with rules of practice adopted by (iii) The flock is tested as provided in the Administrator. § 145.14(d) at intervals of 30 days or less (b) U.S. M. Gallisepticum Clean State, and found to be negative, and a total of Meat-Type Chickens. (1) A State will be

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declared a U.S. M. Gallisepticum Clean has been made by the Service and the State, Meat-Type Chickens, when it Official State Agency has been given has been determined by the Service an opportunity for a hearing in accord- that: ance with rules of practice adopted by (i) No M. gallisepticum is known to the Administrator. exist nor to have existed in meat-type [40 FR 1503, Jan. 8, 1975. Redesignated at 44 chicken breeding flocks in production FR 61586, Oct. 26, 1979, and amended at 50 FR within the State during the preceding 19899, May 13, 1985; 54 FR 23957, June 5, 1989; 12 months; 67 FR 8469, Feb. 25, 2002; 72 FR 1419, Jan. 12, (ii) All meat-type chicken breeding 2007; 76 FR 15793, Mar. 22, 2011] flocks in production are classified as U.S. M. Gallisepticum Clean in accord- Subpart D—Special Provisions for ance with §§ 145.33(c) and 145.83(c) or Turkey Breeding Flocks and have met equivalent requirements for M. gallisepticum control under official Products supervision; § 145.41 Definitions. (iii) All hatcheries within the State which handle products from meat-type Except where the context otherwise chicken breeding flocks only handle requires, for the purposes of this sub- products which are classified as U.S. M. part the following terms shall be con- Gallisepticum Clean or have met equiv- strued, respectively, to mean: alent requirements for M. gallisepticum Poults. Newly hatched turkeys. control under official supervision; [36 FR 23112, Dec. 3, 1971, as amended at 41 (iv) All shipments of products from FR 48725, Nov. 5, 1976. Redesignated at 44 FR meat-type chicken breeding flocks 61586, Oct. 26, 1979, and amended at 59 FR other than those classified as U.S. M. 12799, Mar. 18, 1994; 65 FR 8018, Feb. 17, 2000] Gallisepticum Clean, or equivalent, into the State are prohibited; § 145.42 Participation. (v) All persons performing poultry (a) Participating turkey flocks, and disease diagnostic services within the the eggs and poults produced from State are required to report to the Offi- them, shall comply with the applicable cial State Agency within 48 hours the general provisions of subpart A of this source of all specimens from chickens part and the special provisions of this from meat-type chicken breeding subpart D. flocks that have been identified as (b) Hatching eggs shall be fumigated being infected with M. gallisepticum; (see § 147.25 of this chapter) or other- (vi) All reports of M. gallisepticum in- wise sanitized. fection in chickens from meat-type (c) Any nutritive material provided chicken breeding flocks are promptly to poults must be free of the avian followed by an investigation by the Of- pathogens that are officially rep- ficial State Agency to determine the resented in the Plan disease classifica- origin of the infection; tions listed in § 145.10. (vii) All chickens from meat-type [36 FR 23112, Dec. 3, 1971, as amended at 38 chicken breeding flocks found to be in- FR 13707, May 24, 1973; 40 FR 1503, Jan. 8, fected with M. gallisepticum are quar- 1975. Redesignated at 44 FR 61586, Oct. 26, antined until marketed under super- 1979, and amended at 49 FR 19802, May 10, vision of the Official State Agency. 1984; 57 FR 57341, Dec. 4, 1992; 65 FR 8018, Feb. (2) Discontinuation of any of the con- 17, 2000; 68 FR 64511, Nov. 14, 2003] ditions described in paragraph (b)(1) of this section, or if repeated outbreaks of § 145.43 Terminology and classifica- M. gallisepticum occur in meat-type tion; flocks and products. chicken breeding flocks described in Participating flocks, and the eggs paragraph (b)(1)(ii) of this section, or if and poults produced from them, which an infection spreads from the origi- have met the respective requirements nating premises, the Service shall have specified in this section may be des- grounds to revoke its determination ignated by the following terms and the that the State is entitled to this classi- corresponding designs illustrated in fication. Such action shall not be § 145.10: taken until a thorough investigation (a) [Reserved]

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(b) U.S. Pullorum-Typhoid Clean. A wild birds, (b) contaminated feed or flock in which freedom from pullorum waste, or (c) birds, equipment, supplies, and typhoid has been demonstrated to or personnel from flocks infected with the official State agency under the cri- pullorum-typhoid. teria in one of the following paragraphs (3) It is a multiplier breeding flock, (b)(1) through (5) of this section: Pro- or a breeding flock composed of prog- vided, That a flock qualifying by means eny of a primary breeding flock which of a blood test shall be tested within is intended solely for the production of the past 12 months, except that the re- multiplier breeding flocks, that origi- testing of a participating flock which nated from U.S. Pullorum-Typhoid is retained for more than 12 months Clean breeding flocks or from flocks shall be conducted a minimum of 4 that met equivalent requirements weeks after the induction of molt. (See under official supervision, and is lo- § 145.14 relating to the official blood cated in a State in which it has been test where applicable.) determined by the Service that: (1) It has been officially blood tested (i) All turkey hatcheries within the with no reactors. State are qualified as ‘‘National Plan (2) It is a multiplier breeding flock, Hatcheries’’ or have met equivalent re- or a breeding flock composed of prog- quirements for pullorum-typhoid con- eny of a primary breeding flock which trol under official supervision; is intended solely for the production of (ii) All turkey hatchery supply flocks multiplier breeding flocks, and meets within the State are qualified as U.S. the following specifications as deter- Pullorum-Typhoid Clean or have met mined by the Official State Agency and equivalent requirements for pullorum- the Service: typhoid control under official super- (i) The flock is located in a State vision: Provided, That if other domes- where all persons performing poultry ticated fowl, except waterfowl, are disease diagnostic services within the maintained on the same premises as State are required to report to the Offi- the participating flock, freedom from cial State Agency within 48 hours the pullorum-typhoid infection shall be source of all poultry specimens from demonstrated by an official blood test which S. pullorum or S. gallinarum is of each of these fowl; isolated; (iii) All shipments of products other (ii) The flock is composed entirely of than U.S. Pullorum-Typhoid Clean, or birds that originated from U.S. Pul- equivalent, into the State are prohib- lorum-Typhoid Clean breeding flocks ited; or from flocks that met equivalent re- (iv) All persons performing poultry quirements under official supervision; disease diagnostic services within the and State are required to report to the Offi- (iii) The flock is located on a prem- cial State Agency within 48 hours the ises where a flock not classified as U.S. source of all poultry specimens from Pullorum-Typhoid Clean was located which S. pullorum or S. gallinarum is the previous year; Provided, That an isolated; Authorized Testing Agent must blood (v) All reports of any disease out- test up to 300 birds per flock, as de- break involving a disease covered scribed in § 145.14, if the Official State under the Plan are promptly followed Agency determines that the flock has by an investigation by the Official been exposed to pullorum-typhoid. In State Agency to determine the origin making determinations of exposure and of the infection; Provided, That if the setting the number of birds to be blood origin of the infection involves another tested, the Official State Agency shall State, or if there is exposure to poultry evaluate the results of any blood tests, in another State from the infected described in § 145.14(a)(1), that were per- flock, then the National Poultry Im- formed on an unclassified flock located provement Plan will conduct an inves- on the premises during the previous tigation; year; the origins of the unclassified (vi) All flocks found to be infected flock; and the probability of contacts with pullorum or typhoid are quar- between the flock for which qualifica- antined until marketed or destroyed tion is being sought and (a) infected under the supervision of the Official

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State Agency, or until subsequently from female flocks shall be retested at blood tested, following the procedure 28–30 weeks of age and at 4–6 week infor reacting flocks as contained in tervals thereafter. § 145.14(a)(5), and all birds fail to dem- (2) A flock qualified as U.S. M. onstrate pullorum or typhoid infection; Gallisepticum Clean may retain the (vii) [Reserved] classification through its first egg-lay- (viii) Discontinuation of any of the ing cycle, provided it is maintained in conditions or procedures described in isolation and no evidence of M. paragraphs (b)(3)(i), (ii), (iii), (iv), (v), gallisepticum infection is revealed. A and (vi) of this section, or the occur- flock which is molted following com- rence of repeated outbreaks of pul- pletion of an egg-laying cycle and sub- lorum or typhoid in turkey breeding sequently brought back into produc- flocks within or originating within the tion, shall be retested within 2 weeks State shall be grounds for the Service prior to production, as described in to revoke its determination that such paragraph (c)(1) of this section. A State conditions and procedures have been inspector shall visit with the owner or met or complied with. Such action manager of each flock at least once shall not be taken until a thorough in- during each laying cycle to discuss and vestigation has been made by the Serv- ascertain whether the applicable condi- ice and the Official State Agency has tions outlined in § 147.26 of this chapter been given an opportunity to present are being met. If a flock proves to be its views. infected with M. gallisepticum, it shall (4) It is a multiplier breeding flock lose this classification. located in a State which has been de- (3) In order to sell hatching eggs or termined by the Service to be in com- poults of this classification, all hatch- pliance with the provisions of para- ing eggs and poults handled by the par- graph (b)(3) of this section and in which ticipant must be of this classification. pullorum disease or fowl typhoid is not (d) U.S. M. Meleagridis Clean. (1) A known to exist nor to have existed in flock in which freedom from M. turkey hatchery supply flocks within meleagridis has been demonstrated the State during the preceding 24 under the following criteria: months. (i) A sample of 100 birds from each (5) It is a primary breeding flock lo- flock has been tested for M. meleagridis cated in a State determined to be in when more than 12 weeks of age: Pro- compliance with the provisions of para- vided, That to retain this classifica- graph (b)(4), of this section and in tion, a minimum of 30 samples from which a sample of 300 birds from flocks male flocks and 60 samples from female of more than 300, and each bird in flocks shall be retested at 28–30 weeks flocks of 300 or less, has been officially of age and at 4–6 week intervals there- tested for pullorum-typhoid with no re- after. actors: Provided, That a bacteriological (2)–(3) [Reserved] examination monitoring program ac- (4) When reactors to the official test ceptable to the Official State Agency are found and can be identified, 10 tra- and approved by the Service may be cheal swabs and/or vaginal or phallus used in lieu of blood testing. swabs and their corresponding blood (c) U.S. M. Gallisepticum Clean. (1) A samples shall be submitted to a labora- flock maintained in accordance with tory for serological and cultural exam- the conditions and procedures de- ination. If reactors cannot be identi- scribed in § 147.26 of this chapter, and in fied, at least 30 tracheal swabs and/or which no reactors are found when a vaginal or phallus swabs and their cor- random sample of at least 10 percent of responding blood samples shall be sub- the birds in the flock, or 300 birds in mitted. In a flock with a low reactor flocks of more than 300 and each bird in rate (less than 5 reactors) the reactors flocks of 300 or less, is tested when may be submitted to the laboratory more than 12 weeks of age, in accord- within 10 days for serology, necropsy, ance with the procedures described in and thorough bacteriological examina- § 145.14(b): Provided, That to retain this tion. classification, a minimum of 30 sam- (5) If a mycoplasma is isolated, the ples from male flocks and 60 samples organism must be serotyped. If M.

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meleagridis is isolated, the block shall the poults that died within 10 days be considered infected. after hatching up to 10 poults, or a (e) U.S. M. Synoviae Clean. (1) All combination of 2 or all 3 of the above, birds, or a sample of at least 100 birds from each hatch or a candidate breed- from flocks of more than 100 and each ing flock produced by a primary breed- bird in flocks of 100 or less, have been er, are examined bacteriologically at tested for M. synoviae when more than an authorized laboratory for Sal- 12 weeks of age in accordance with the monella. procedures in § 145.14(b): Provided, That (2) The poults for the candidate to retain this classification a minimum breeding flock are placed in a building of 30 samples from male flocks and 60 that has been cleaned and disinfected. samples from female flocks shall be re- An Authorized Agent must collect en- tested at 28–30 weeks of age and at 4–6 vironmental samples from the building week intervals thereafter. and submit them to an authorized lab- (2) When reactors to the official test oratory for a bacteriological examina- are found and can be identified, tration for the presence of Salmonella, as cheal swabs and their corresponding described in § 147.12 of this subchapter. blood samples from 10 (all if fewer than (3) Feed for turkeys in the candidate 10) reacting birds shall be submitted to and breeding flock should meet the fol- an authorized laboratory for sero- lowing requirements: logical and cultural examination. If re- (i) All feed manufactured in pellet actors cannot be identified, at least 30 form must have a maximum moisture tracheal swabs and their corresponding content of 13.5 percent upon delivery to blood samples shall be submitted. In a the farm. It should have been flock with a low reactor rate (less than preconditioned to the minimum of one five reactors) the reactors may be sub- of the following parameters before mitted to the laboratory within 10 days pelleting: for serology, necropsy, and thorough (A) Feed is to reach a minimum tem- bacteriological examination. When re- perature of 185 °F for a minimum of 6 actors to the official test are found, the minutes of retention in the condi- procedures outlined in § 147.6 of this tioning chamber. The conditioned chapter will be used to determine the mash feed moisture must be a min- status of the flock. imum of 16 percent during the condi- (3) Flocks located on premises which, tioning process. This method utilizes during 3 consecutive years, have con- time retention to allow permeation to tained breeding flocks qualified as U.S. the center core of each feed particle; or M. Synoviae Clean, as described in paragraph (e)(1) above, may qualify for (B) The feed is to be pressurized in this classification by a negative blood order to expedite the transfer of the test of at least 100 birds from flocks of heat and moisture to the core of each more than 100 and each bird in flocks of feed particle. The feed should be conditioned to the parameters of a minimum 100 or less, when more than 12 weeks of ° age, and by testing a minimum of 30 of 16 percent moisture and 200 F; or samples from male flocks and 60 sam- (C) The feed should be submitted to ples from female flocks at 28–30 weeks pressurization to the extent that the ° of age and at 45 weeks of age. initial feed temperature rises to 235 F (f) U.S. Sanitation Monitored, Turkeys. for 4 seconds; or A flock or hatchery whose owner is (D) The feed should be submitted to controlling or reducing the level of sal- an equivalent thermal lethality treat- monella through compliance with sani- ment; or tation and management practices as (E) A Food and Drug Administration described in subpart C of part 147 of (FDA)-approved product for Salmonella this chapter, and where the following control should be added to the finished monitoring, testing, and management pellets. practices are conducted: (ii) Mash feed should be treated with (1) Hatchery debris (dead germ hatch- an FDA-approved Salmonella control ing eggs, fluff, and meconium collected product. by sexors), swabs collected from hatch (iii) All feed is to be stored and trans- debris in hatcher trays, a sample of all ported in such a manner as to prevent

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possible contamination with patho- (i) A sample of at least 30 birds must genic bacteria. be tested negative at intervals of 90 (iv) FDA-approved products for Sal- days; or monella control may be added to either (ii) A sample of fewer than 30 birds unfinished or finished feed. may be tested, and found to be nega- (4) Environmental samples shall be tive, at any one time if all pens are taken by an Authorized Agent, as de- equally represented and a total of 30 scribed in § 147.12 of this chapter, from birds are tested within each 90-day pe- each flock at 12–20 weeks of age and ex- riod. amined bacteriologically at an author- (2) It is a multiplier breeding flock in ized laboratory for Salmonella. which a minimum of 30 birds have been (5) Owners of flocks found infected tested negative to the H5/H7 subtypes with a paratyphoid Salmonella may of avian influenza as provided in vaccinate these flocks with an autog- § 145.14(d) when more than 4 months of enous bacterin with a potentiating age and prior to the onset of egg pro- agent. 5 duction. To retain this classification: (6) Environmental samples shall be (i) A sample of at least 30 birds must taken by an Authorized Agent, as de- be tested negative at intervals of 90 scribed in § 147.12 of this chapter, from days; or each flock at 35–50 weeks of age and (ii) A sample of fewer than 30 birds from each molted flock at midlay, and may be tested, and found to be nega- examined bacteriologically at an au- tive, at any one time if all pens are thorized laboratory for Salmonella. equally represented and a total of 30 (7) Hatchery debris (dead germ hatch- birds are tested within each 90-day pe- ing eggs, fluff, and meconium collected riod. by sexors), swabs collected from hatch (3) During each 90-day period, all debris in hatcher trays, a sample of all spent fowl, up to a maximum of 30, the poults that died within 10 days must be tested and found negative after hatching up to 10 poults, or a within 21 days prior to movement to combination of 2 or all 3 of the above, slaughter. shall be cultured as a means of evalu- (4) For both primary and multiplier ating the effectiveness of the control breeding flocks, if a killed influenza procedures. vaccine against avian influenza (g) U.S. H5/H7 Avian Influenza Clean. subtypes other than H5 and H7 is used, This program is intended to be the then the hemagglutinin and the basis from which the turkey breeding neuraminidase subtypes of the vaccine industry may conduct a program for must be reported to the Official State the prevention and control of the H5/H7 Agency for laboratory and reporting subtypes of avian influenza. It is in- purposes. tended to determine the presence of the (Approved by the Office of Management and H5/H7 subtypes of avian influenza in Budget under control number 0579–0007) breeding turkeys through routine sur- [36 FR 23112, Dec. 3, 1971] veillance of each participating breed- EDITORIAL NOTE: For FEDERAL REGISTER ci- ing flock. A flock, and the hatching tations affecting § 145.43, see the List of CFR eggs and poults produced from it, will Sections Affected, which appears in the qualify for this classification when the Finding Aids section of the printed volume Official State Agency determines that and at www.fdsys.gov. it has met one of the following requirements: § 145.44 Terminology and classifica- (1) It is a primary breeding flock in tion; States. which a minimum of 30 birds have been (a) U.S. Pullorum-Typhoid Clean State. tested negative to the H5/H7 subtypes (1) A State will be declared a U.S. Pul- of avian influenza as provided in lorum-Typhoid Clean State when it has § 145.14(d) when more than 4 months of been determined by the Service that: age and prior to the onset of egg pro- (i) The State is in compliance with duction. To retain this classification: the provisions contained in § 145.23(b)(3)(i) through (vii), 5 Preparation and use of this type of vac- § 145.33(b)(3)(i) through (vii), cine may be regulated by state statutes. § 145.43(b)(3)(i) through (vi),

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§ 145.53(b)(3)(i) through (vii), of practice adopted by the Adminis- § 145.73(b)(2)(i), § 145.83(b)(2)(i), and trator. § 145.93(b)(3)(i) through (vii). (c) U.S. M. Gallisepticum Clean State, (ii) No pullorum disease or fowl ty- Turkeys. (1) A State will be declared a phoid is known to exist nor to have ex- U.S. M. Gallisepticum Clean State, isted in hatchery supply flocks within Turkeys when it has been determined the State during the preceding 12 by the Service that: months: Provided, That pullorum dis- (i) No M. gallisepticum is known to ease or fowl typhoid found within the exist nor to have existed in turkey preceding 24 months in waterfowl, exhi- breeding flocks in production within bition poultry, and game bird breeding the State during the preceding 12 flocks will not prevent a State, which months. is otherwise eligible, from qualifying. (ii) All turkey breeding flocks in pro- (2) Discontinuation of any of the con- duction are classified as U.S. M. ditions described in paragraph (a)(1)(i) Gallisepticum Clean or have met equiv- of this section, or repeated outbreaks alent requirements for M. gallisepticum of pullorum or typhoid occur in hatch- control under official supervision. ery supply flocks described in para- (iii) All turkey hatcheries within the graph (a)(1)(ii) of this section, or if an State handle products which are classi- infection spreads from the originating fied as U.S. M. Gallisepticum Clean or premises, the Service shall have have met equivalent requirements for grounds to revoke its determination M. gallisepticum control under official that the State is entitled to this classi- supervision. fication. Such action shall not be taken until a thorough investigation (iv) All shipments of turkey products has been made by the Service and the other than those classified as U.S. M. Official State Agency has been given Gallisepticum Clean, or equivalent, an opportunity for a hearing in accord- into the State are prohibited. ance with rules of practice adopted by (v) All persons performing poultry the Administrator. disease diagnostic services within the (b) U.S. Pullorum-Typhoid Clean State, State are required to report to the Offi- Turkeys. (1) A State will be declared a cial State Agency within 48 hours the U.S. Pullorum-Typhoid Clean State, source of all turkey specimens that Turkeys, when it has been determined have been identified as being infected by the Service that: with M. gallisepticum. (i) The State is in compliance with (vi) All reports of M. gallisepticum in- the provisions contained in fection in turkeys are promptly fol- § 145.43(b)(3)(i) through (vi). lowed by an investigation by the Offi- (ii) No pullorum disease or fowl ty- cial State Agency to determine the ori- phoid is known to exist nor to have ex- gin of the infection. isted in turkey hatchery supply flocks (vii) All turkey flocks found to be in- within the State during the preceding fected with M. gallisepticum are quar- 24 months. antined until marketed under super- (2) Discontinuation of any of the con- vision of the Official State Agency. ditions described in paragraph (b)(1)(i) (2) Discontinuation of any of the con- of this section, or repeated outbreaks ditions described in paragraph (c)(1) of of pullorum or typhoid occur in hatch- this section, or if repeated outbreaks of ery supply flocks described in para- M. gallisepticum occur in turkey breed- graph (b)(1)(ii) of this section, or if an ing flocks described in paragraph infection spreads from the originating (c)(1)(ii) of this section, or if an infec- premises, Service shall have grounds to tion spreads from the originating revoke its determination that the premises, the Service shall have State is entitled to this classification. grounds to revoke its determination Such action shall not be taken until a that the State is entitled to this classi- thorough investigation has been made fication. Such action shall not be by the Service and the Official State taken until a thorough investigation Agency has been given an opportunity has been made by the Service and the for a hearing in accordance with rules Official State Agency has been given

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an opportunity for a hearing in accord- Official State Agency has been given ance with rules of practice adopted by an opportunity for a hearing in accord- the Administrator. ance with rules of practice adopted by (3) If a State retains this status for 2 the Administrator of the Service. or more years, individual breeding (e) U.S. M. Meleagridis Clean State, flocks in the State may qualify for an Turkeys. (1) A State will be declared a M. gallisepticum classification based on U.S. M. Meleagridis Clean State, Tur- a negative test of a sample of 100 birds. keys, if the Service determines that: (d) U.S. M. Synoviae Clean State, Tur- (i) No Mycoplasma meleagridis is keys. (1) A State will be declared a U.S. known to exist nor to have existed in M. Synoviae Clean State, Turkeys, if turkey breeding flocks in production the Service determines that: within the State during the preceding (i) No Mycoplasma synoviae is known 12 months; to exist nor to have existed in turkey breeding flocks in production within (ii) All turkey breeding flocks in pro- the State during the preceding 12 duction are tested and classified as months; U.S. M. Meleagridis Clean or have met (ii) All turkey breeding flocks in pro- equivalent requirements for M. duction are tested and classified as meleagridis control under official super- U.S. M. Synoviae Clean or have met vision; equivalent requirements for M. (iii) All turkey hatcheries within the synoviae control under official super- State only handle products that are vision; classified as U.S. M. Meleagridis Clean (iii) All turkey hatcheries within the or have met equivalent requirements State only handle products that are for M. meleagridis control under official classified as U.S. M. Synoviae Clean or supervision; have met equivalent requirements for (iv) All shipments of products from M. synoviae control under official su- turkey breeding flocks other than pervision; those classified as U.S. M. Meleagridis (iv) All shipments of products from Clean, or equivalent, into the State are turkey breeding flocks other than prohibited; those classified as U.S. M. Synoviae (v) All persons performing poultry Clean, or equivalent, into the State are disease diagnostic services within the prohibited; State are required to report to the Offi- (v) All persons performing poultry cial State Agency within 48 hours the disease diagnostic services within the source of all turkey specimens that State are required to report to the Offi- have been identified as being infected cial State Agency within 48 hours the with M. meleagridis; source of all turkey specimens that (vi) All reports of M. meleagridis in- have been identified as being infected fection in turkeys are promptly fol- with M. synoviae; lowed by an investigation by the Offi- (vi) All reports of M. synoviae infec- cial State Agency to determine the ori- tion in turkeys are promptly followed gin of the infection; and by an investigation by the Official State Agency to determine the origin (vii) All turkey breeding flocks found of the infection; and to be infected with M. meleagridis are (vii) All turkey breeding flocks found quarantined until marketed under su- to be infected with M. synoviae are pervision of the Official State Agency. quarantined until marketed under su- (2) The Service may revoke the pervision of the Official State Agency. State’s classification as a U.S. M. (2) The Service may revoke the Meleagridis Clean State, Turkeys, if State’s classification as a U.S. M. any of the conditions described in para- Synoviae Clean State, Turkeys, if any graph (d)(1) of this section are discon- of the conditions described in para- tinued. The Service will not revoke the graph (d)(1) of this section are discon- State’s classification as a U.S. M. tinued. The Service shall not revoke Meleagridis Clean State, Turkeys, the State’s classification as a U.S. M. until it has conducted an investigation Synoviae Clean State, Turkeys, until it and the Official State Agency has been has conducted an investigation and the given an opportunity for a hearing in

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accordance with rules of practice (c) Subject to the approval of the adopted by the Administrator. Service and the Official State Agencies in the importing and exporting States, (Approved by the Office of Management and participating flocks may report poul- Budget under control number 0579–0007) try sales to importing States by using [40 FR 1503, Jan. 8, 1975. Redesignated at 44 either VS Form 9–3, ‘‘Report of Sales of FR 61586, Oct. 26, 1979, and amended at 45 FR Hatching Eggs, Chicks, and Poults,’’ or 10316, Feb. 15, 1980; 48 FR 57473, Dec. 30, 1983; by using a hatchery invoice form (9–3I) 49 FR 19803, May 10, 1984; 54 FR 23957, June 5, 1989; 61 FR 11521, Mar. 21, 1996; 65 FR 8018, approved by the Official State Agency Feb. 17, 2000; 67 FR 8469, Feb. 25, 2002; 76 FR and the Service to identify poultry 15793, Mar. 22, 2011] sales to clients. If the selling hatchery uses the 9–3I form, the following infor- Subpart E—Special Provisions for mation must be included on the form: (1) The form number ‘‘9–3I’’, printed Hobbyist and Exhibition Wa- or stamped on the invoice; terfowl, Exhibition Poultry, and (2) The hatchery name and address; Game Bird Breeding Flocks (3) The date of shipment; and Products (4) The hatchery invoice number; (5) The purchaser name and address; § 145.51 Definitions. (6) The quantity of products sold; Except where the context otherwise (7) Identification of the products by requires, for the purposes of this sub- bird variety or by NPIP stock code as part the following terms shall be con- listed in the NPIP APHIS 91–55–078 ap- strued, respectively, to mean: pendix; and Exhibition Poultry. Domesticated fowl (8) The appropriate NPIP illustrative which are bred for the combined pur- design in § 145.10. One of the designs in poses of meat or egg production and § 145.10(b) or (g) must be used. The fol- competitive showing. lowing information must be provided in Game birds. Domesticated fowl such or near the NPIP design: as pheasants, partridge, quail, grouse, (i) The NPIP State number and NPIP and guineas, but not doves and pigeons. hatchery approval number; and Waterfowl. Domesticated fowl that (ii) The NPIP classification for which normally swim, such as ducks and product is qualified (e.g., U.S. Pul- geese. lorum-Typhoid Clean). (d) Any nutritive material provided [36 FR 23112, Dec. 3, 1971. Redesignated at 44 to baby poultry must be free of the FR 61586, Oct. 26, 1979, and amended at 59 FR avian pathogens that are officially rep- 12799, Mar. 18, 1994] resented in the Plan disease classifica- § 145.52 Participation. tions listed in § 145.10. Participating flocks of hobbyist and [36 FR 23112, Dec. 3, 1971. Redesignated at 44 exhibition waterfowl, exhibition poul- FR 61586, Oct. 26, 1979, and amended at 49 FR 19803, May 10, 1984; 57 FR 57341, Dec. 4, 1992; try, and game birds, and the eggs and 61 FR 11521, Mar. 21, 1996; 65 FR 8019, Feb. 17, baby poultry produced from them shall 2000; 74 FR 14715, Apr. 1, 2009; 76 FR 15793, comply with the applicable general Mar. 22, 2011] provisions of subpart A of this part and the special provisions of this subpart E. § 145.53 Terminology and classifica- The special provisions that apply to tion; flocks and products. meat-type waterfowl flocks are found Participating flocks, and the eggs in subpart I of this part. and baby poultry produced from them, (a) Started poultry shall lose their which have met the respective require- identity under Plan terminology when ments specified in this section may be not maintained by Plan participants designated by the following terms and under the conditions prescribed in the corresponding designs illustrated § 145.5(a). in § 145.10. (b) Hatching eggs produced by pri- (a) [Reserved] mary breeding flocks shall be fumi- (b) U.S. Pullorum-Typhoid Clean. A gated (see § 147.25 of this chapter) or flock in which freedom from pullorum otherwise sanitized. and typhoid has been demonstrated to

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the Official State Agency under the located in a State in which it has been criteria in one of the following para- determined by the Service that: graphs (b)(1) through (5) of this section (i) All hatcheries within the State (See § 145.14 relating to the official are qualified as ‘‘National Plan Hatch- blood test where applicable.): eries’’ or have met equivalent require- (1) It has been officially blood tested ments for pullorum-typhoid control within the past 12 months with no reac- under official supervision; tors. (ii) All hatchery supply flocks within (2) It is a multiplier breeding flock, the State, are qualified as U.S. Pul- or a breeding flock composed of prog- lorum-Typhoid Clean or have met eny of a primary breeding flock which equivalent requirements for pullorum- is intended solely for the production of typhoid control under official super- multiplier breeding flocks, and meets vision: Provided, That if other domes- the following specifications as deter- ticated fowl, except waterfowl, are mined by the Official State Agency and maintained on the same premises as the Service: the participating flock, freedom from (i) The flock is located in a State pullorum-typhoid infection shall be where all persons performing poultry demonstrated by an official blood test disease diagnostic services within the of each of these fowl; State are required to report to the Offi- (iii) All shipments of products other cial State Agency within 48 hours the than U.S. Pullorum-Typhoid Clean, or source of all poultry specimens from equivalent, into the State are prohib- which S. pullorum or S. gallinarum is ited; isolated; (iv) All persons performing poultry (ii) The flock is composed entirely of disease diagnostic services within the birds that originated from U.S. Pul- State are required to report to the Offi- lorum-Typhoid Clean breeding flocks cial State Agency within 48 hours the or from flocks that met equivalent resource of all poultry specimens from quirements under official supervision; which S. pullorum or S. gallinarum is and isolated; (iii) The flock is located on a prem- (v) All reports of any disease out- ises where a flock not classified as U.S. break involving a disease covered Pullorum-Typhoid Clean was located under the Plan are promptly followed the previous year; Provided, That an by an investigation by the Official Authorized Testing Agent must blood State Agency to determine the origin test up to 300 birds per flock, as de- of the infection; Provided, That if the scribed in § 145.14, if the Official State origin of the infection involves another Agency determines that the flock has State, or if there is exposure to poultry been exposed to pullorum-typhoid. In in another State from the infected making determinations of exposure and flock, then the National Poultry Im- setting the number of birds to be blood provement Plan will conduct an inves- tested, the Official State Agency shall tigation; evaluate the results of any blood tests, (vi) All flocks found to be infected described in § 145.14(a)(1), that were per- with pullorum or typhoid are quar- formed on an unclassified flock located antined until marketed or destroyed on the premises during the previous under the supervision of the Official year; the origins of the unclassified State Agency, or until subsequently flock; and the probability of contacts blood tested, following the procedure between the flock for which qualifica- for reacting flocks as contained in tion is being sought and (a) infected § 145.14(a)(5), and all birds fail to dem- wild birds, (b) contaminated feed or onstrate pullorum or typhoid infection; waste, or (c) birds, equipment, supplies, (vii) All poultry, including exhi- or personnel from flocks infected with bition, exotic, and game birds, but ex- pullorum-typhoid. cluding waterfowl, going to public ex- (3) It is a multiplier breeding flock hibition shall come from U.S. Pul- that originated from U.S. Pullorum- lorum-Typhoid Clean or equivalent Typhoid Clean breeding flocks or from flocks, or have had a negative pul- flocks that met equivalent require- lorum-typhoid test within 90 days of ments under official supervision, and is going to public exhibition;

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(viii) Discontinuation of any of the the provisions of § 147 .26 of this chap- conditions or procedures described in ter and in which freedom from M. paragraphs (b)(3)(i), (ii), (iii), (iv), (v), gallisepticum has been demonstrated (vi), and (vii) of this section, or the oc- under the criteria specified in para- currence of repeated outbreaks of pul- graph (c)(1)(i) or (ii) of this section. lorum or typhoid in poultry breeding (i) It is a flock in which all birds or flocks within or originating within the a sample of at least 300 birds has been State shall be grounds for the Service tested for M. gallisepticum as provided to revoke its determination that such in § 145.14(b) when more than 4 months conditions and procedures have been of age or upon reaching sexual matu- met or complied with. Such action rity: Provided, That to retain this clas- shall not be taken until a thorough in- sification, a random sample of serum vestigation has been made by the Serv- or egg yolk from at least 5 percent of ice and the Official State Agency has the birds in the flock, but at least 30 been given an opportunity to present birds, shall be tested at intervals of not its views. more than 90 days: And provided fur- (4) It is a multiplier breeding flock ther, That a sample comprised of less located in a State which has been de- than 5 percent may be tested at any termined by the Service to be in com- one time, with the approval of the Offi- pliance with the provisions of para- cial State Agency and the concurrence graph (b)(3) of this section, and in of the Service, provided that a total of which pullorum disease or fowl typhoid at least 5 percent of the birds in the is not known to exist nor to have ex- flock, but at least 30 birds, is tested isted in hatchery supply flocks within within each 90–day period; or the State during the preceding 24 (ii) It is a multiplier breeding flock months. which originated as U.S. M. (5) It is a primary breeding flock lo- Gallisepticum Clean baby poultry from cated in a State determined to be in primary breeding flocks and a random compliance with the provisions of para- sample comprised of 50 percent of the graph (b)(4) of this section, and in birds in the flock, with a maximum of which a sample of 300 birds from flocks 200 birds and a minimum of 30 birds per of more than 300, and each bird in flock, has been tested for M. flocks of 300 or less, has been officially gallisepticum as provided in § 145.14(b) tested for pullorum-typhoid within the when more than 4 months of age or past 12 months with no reactors: Pro- upon reaching sexual maturity: Pro- vided, That a bacteriological examina- vided, That to retain this classification monitoring program or serological tion, the flock shall be subjected to one examination monitoring program for of the following procedures: game birds acceptable to the Official (A) At intervals of not more than 90 State Agency and approved by the days, a random sample of serum or egg Service may be used in lieu of annual yolk from at least 2 percent of the blood testing: And Provided further, birds in the flock, with a minimum of That when a flock is a hobbyist or ex- 30 birds per pen, shall be tested; or hibition waterfowl or exhibition poul- (B) At intervals of not more than 30 try primary breeding flock located in a days, a sample of 25 cull baby poultry State which has been deemed to be a produced from the flock shall be sub- U.S. Pullorum-Typhoid Clean State for jected to laboratory procedures accept- the past three years, and during which able to the Official State Agency and time no isolation of pullorum or ty- approved by the Service, for the detec- phoid has been made that can be traced tion and recovery of M. gallisepticum. to a source in that State, a bacterio- (2) A participant handling U.S. M. logical examination monitoring pro- Gallisepticum Clean products shall gram or a serological examination keep these products separate from monitoring program acceptable to the other products in a manner satisfac- Official State Agency and approved by tory to the Official State Agency: Pro- the Service may be used in lieu of an- vided, That U.S. M. Gallisepticum nual blood testing. Clean baby poultry from primary (c) U.S. M. Gallisepticum Clean. (1) A breeding flocks shall be produced in in- flock maintained in compliance with cubators and hatchers in which only

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eggs from flocks qualified under para- from primary breeding flocks shall be graph (c)(1)(i) of this section are set. produced in incubators and hatchers in (3) U.S. M. Gallisepticum Clean baby which only eggs from flocks qualified poultry shall be boxed in clean boxes under paragraph (d)(1)(i) or (d)(1)(ii) of and delivered in trucks that have been this section are set. cleaned and disinfected as described in (3) U.S. M. Synoviae Clean chicks § 147.24(a) of this chapter. shall be boxed in clean boxes and deliv- (d) U.S. M. Synoviae Clean. (1) A flock ered in trucks that have been cleaned maintained in compliance with the and disinfected as described in provisions of § 147.26 of this chapter and § 147.24(a) of this chapter. in which freedom from Mycoplasma (e) U.S. H5/H7 Avian Influenza Clean. synoviae has been demonstrated under This program is intended to be the the criteria specified in paragraph basis from which the breeding-hatchery (d)(1)(i) or (d)(1)(ii) of this section. industry may conduct a program for (i) It is a flock in which a minimum the prevention and control of the H5 of 300 birds has been tested for M. and H7 subtypes of avian influenza. It synoviae as provided in § 145.14(b) when is intended to determine the presence more than 4 months of age: Provided, of the H5 and H7 subtypes of avian in- That to retain this classification, a fluenza in hobbyist or exhibition wa- sample of at least 150 birds shall be terfowl, exhibition poultry, and game tested at intervals of not more than 90 bird breeding flocks through routine days: And provided further, That a sam- surveillance of each participating ple comprised of fewer than 150 birds breeding flock. A flock, and the hatch- may be tested at any one time with the ing eggs and chicks produced from it, approval of the Official State Agency will qualify for this classification when and the concurrence of the Service, the Official State Agency determines provided that a minimum of 150 birds is that it has met one of the following retested within each 90-day period; or quirements: (ii) It is a multiplier breeding flock (1) It is a primary breeding flock in that originated as U.S. M. Synoviae Clean chicks from primary breeding which a minimum of 30 birds has been flocks and from which a sample com- tested negative to the H5 and H7 prised of a minimum of 75 birds has subtypes of avian influenza as provided in § 145.14(d) when more than 4 months been tested for M. synoviae as provided in § 145.14(b) when more than 4 months of age. To retain this classification: of age: Provided, That to retain this (i) A sample of at least 30 birds must classification, the flock shall be sub- be tested negative at intervals of 90 jected to one of the following proce- days; or dures: (ii) A sample of fewer than 30 birds (A) At intervals of not more than 90 may be tested, and found to be nega- days, a sample of 50 birds shall be test- tive, at any one time if all pens are ed: Provided, That a sample of fewer equally represented and a total of 30 than 50 birds may be tested at any one birds are tested within each 90-day pe- time, provided that a minimum of 30 riod. birds per flock with a minimum of 15 (2) It is a multiplier breeding flock in birds per pen, whichever is greater, is which a minimum of 30 birds has been tested each time and a total of at least tested negative to the H5 and H7 50 birds is tested within each 90-day pe- subtypes of avian influenza as provided riod; or in § 145.14(d) when more than 4 months (B) At intervals of not more than 30 of age. To retain this classification: days, egg yolk testing shall be con- (i) A sample of at least 30 birds must ducted in accordance with § 147.8 of this be tested negative at intervals of 180 chapter. days; or (2) A participant handling U.S. M. (ii) A sample of fewer than 30 birds Synoviae Clean products shall keep may be tested, and found to be nega- those products separate from other tive, at any one time if all pens are products in a manner satisfactory to equally represented and a total of 30 the Official State Agency: Provided, birds are tested within each 180-day pe- That U.S. M. Synoviae Clean chicks riod.

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(3) During each 90-day period, all ance with rules of practice adopted by spent fowl, up to a maximum of 30, the Administrator. must be tested and found negative [40 FR 1504, Jan. 8, 1975. Redesignated at 44 within 21 days prior to movement to FR 61586, Oct. 26, 1979, and amended at 54 FR slaughter. 23957, June 5, 1989; 67 FR 8469, Feb. 25, 2002; 76 FR 15794, Mar. 22, 2011] (Approved by the Office of Management and Budget under control number 0579–0007) Subpart F—Special Provisions for [36 FR 23112, Dec. 3, 1971. Redesignated at 44 Ostrich, Emu, Rhea, and Cas- FR 61586, Oct. 26, 1979] sowary Breeding Flocks and EDITORIAL NOTE: For FEDERAL REGISTER ci- Products tations affecting § 145.53, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume SOURCE: 63 FR 40010, July 27, 1998, unless and at www.fdsys.gov. otherwise noted.

§ 145.54 Terminology and classifica- § 145.61 Definitions. tion; States. Except where the context otherwise (a) U.S. Pullorum-Typhoid Clean State. requires, for the purposes of this sub- (1) A State will be declared a U.S. Pul- part the following terms shall be construed, respectively, to mean: lorum-Typhoid Clean State when it has Chicks. Newly hatched ostriches, been determined by the Service that: emus, rheas, or cassowaries. (i) The State is in compliance with Ostrich. Birds of the species Struthio the provisions contained in camelus, including all subspecies and § 145.23(b)(3)(i) through (vii), subspecies hybrids. § 145.33(b)(3)(i) through (vii), § 145.43(b)(3)(i) through (vi), [63 FR 40010, July 27, 1998, as amended at 65 § 145.53(b)(3)(i) through (vii), FR 8019, Feb. 17, 2000] § 145.73(b)(2)(i), § 145.83(b)(2)(i), and § 145.62 Participation. § 145.93(b)(3)(i) through (vii). (ii) No pullorum disease or fowl ty- Participating flocks of ostriches, emus, rheas, and cassowaries, and the phoid is known to exist nor to have ex- eggs and chicks produced from them, isted in hatchery supply flocks within shall comply with the applicable gen- the State during the preceding 12 eral provisions of subpart A of this part months: Provided, That pullorum dis- and the special provisions of this sub- ease or fowl typhoid found within the part. preceding 24 months in waterfowl, exhi- (a) Started poultry shall lose their bition poultry, and game bird breeding identity under Plan terminology when flocks will not prevent a State, which not maintained by Plan participants is otherwise eligible, from qualifying. under the conditions prescribed in (2) Discontinuation of any of the con- § 145.5(a). ditions described in paragraph (a)(1)(i) (b) Hatching eggs produced by pri- of this section, or repeated outbreaks mary breeding flocks shall be fumi- of pullorum or typhoid occur in hatch- gated or otherwise sanitized (see ery supply flocks described in para- § 147.22 of this chapter). graph (a)(1)(ii) of this section, or if an (c) Any nutritive material provided infection spreads from the originating to chicks must be free of the avian premises, the Service shall have pathogens that are officially rep- grounds to revoke its determination resented in the Plan disease classifica- that the State is entitled to this classi- tions listed in § 145.10. fication. Such action shall not be [63 FR 40010, July 27, 1998, as amended at 65 taken until a thorough investigation FR 8019, Feb. 17, 2000] has been made by the Service and the Official State Agency has been given § 145.63 Terminology and classifica- an opportunity for a hearing in accord- tion; flocks and products. Participating flocks, and the eggs and baby poultry produced from them,

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that have met the respective require- prevention and control of avian influ- ments specified in this section may be enza. It is intended to determine the designated by the following terms and presence of avian influenza in all os- their corresponding designs illustrated trich, emu, rhea, and cassowary breed- in § 145.10. ing flocks through routine serological (a) U.S. Pullorum-Typhoid Clean. A surveillance of each participating flock in which freedom from pullorum breeding flock. Acceptable tests in- and typhoid has been demonstrated to clude antigen and antibody detection the Official State Agency under the tests, as approved by the Official State criteria in paragraph (a)(1) or (a)(2) of Agency. A flock, and the hatching eggs this section. (See § 145.14(a) relating to and chicks produced from it, will qual- the official blood test for pullorum-ty- ify for this classification when the Offi- phoid where applicable.) cial State Agency determines that it (1) It has been officially blood tested has met one of the following require- within the past 12 months with no reac- ments: tors. (1) It is a primary breeding flock in (2) It is a breeding flock that meets which 10 percent of the flock, up to a one of the following criteria: maximum of 30 birds, has been tested (i)(A) It is a multiplier or primary negative for type A influenza virus breeding flock of fewer than 300 birds with all pens represented equally and in which a sample of 10 percent of the when the tested birds are more than 4 birds in a flock or at least 1 bird from months of age. Positive samples shall each pen, whichever is more, has been be further tested by an authorized lab- officially tested for pullorum-typhoid oratory. To retain this classification: within the past 12 months with no reac- (i) A sample of at least 30 birds must tors; or be tested negative at intervals of 180 (B) It is a multiplier or primary days, or breeding flock of 300 birds or more in (ii) A sample of less than 10 percent which a sample of a minimum of 30 of the birds, up to a maximum of 30 birds has been officially tested for pul- birds, may be tested and found to be lorum-typhoid within the past 12 negative at any one time if all pens are months with no reactors. equally represented and a total of 30 (ii) It is a flock that has already been birds are tested within each 180-day pe- designated U.S. Pullorum-Typhoid riod. Clean and uses a subsequent bacterio- (2) It is a multiplier breeding flock in logical examination monitoring pro- which a minimum of 30 birds has been gram of hatcher debris or eggs for os- tested negative to type A influenza triches, emus, rheas, or cassowaries ac- virus with all pens represented equally ceptable to the Official State Agency and when the tested birds are more and approved by the Service in lieu of than 4 months of age. Positive samples annual blood testing. shall be further tested by an authorized (iii) It is a multiplier breeding flock laboratory. To retain this classifica- located in a State that has been tion: deemed to be a U.S. Pullorum-Typhoid (i) A sample of at least 30 birds must Clean State for the past 3 years, and be tested negative at intervals of 180 during which time no isolation of pul- days, or lorum or typhoid has been made that (ii) A sample of at least 10 percent of can be traced to a source in that State, birds from each pen with all pens being that uses a bacteriological examina- represented must be tested negative at tion monitoring program of hatcher de- intervals of 180 days; or bris or eggs or a serological examina- (iii) A sample of less than 10 percent tion monitoring program acceptable to of the birds may be tested, and found the Official State Agency and approved to be negative, at any one time if all by the Service in lieu of annual blood pens are equally represented and a testing. total of 10 percent of the birds are test- (b) U.S. Avian Influenza Clean. This ed within each 180-day period. program is intended to be the basis [63 FR 40010, July 27, 1998, as amended at 65 from which the breeding-hatchery in- FR 8019, Feb. 17, 2000; 72 FR 1420, Jan. 12, dustry may conduct a program for the 2007; 74 FR 14715, Apr. 1, 2009]

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Subpart G—Special Provisions for (a) [Reserved] Primary Egg-Type Chicken (b) U.S. Pullorum-Typhoid Clean. A Breeding Flocks and Prod- flock in which freedom from pullorum and typhoid has been demonstrated to ucts the Official State Agency under the criteria in paragraph (b)(1) or (b)(2) of SOURCE: 72 FR 1420, Jan. 12, 2007, unless this section: Provided, That a flock otherwise noted. qualifying by means of a blood test shall be tested within the past 12 § 145.71 Definitions. months, except that the retesting of a Except where the context otherwise participating flock which is retained requires, for the purposes of this sub- for more than 12 months shall be con- part the following terms shall be conducted a minimum of 4 weeks after the strued, respectively, to mean: induction of molt. (See § 145.14 relating Chicks. Newly hatched chickens. to the official blood test where applica- Primary egg-type chicken breeding ble.) flocks. Foundation flocks that are com- (1) It has been officially blood tested posed of pedigree, great-grandparent, with no reactors. and grandparent stock that has been (2) It is a primary breeding flock that developed for egg production and are meets the following criteria: maintained for the principal purpose of (i) The primary breeding flock is lo- producing multiplier breeding chicks cated in a State in which pullorum dis- used to produce table egg layers. ease or fowl typhoid is not known to Started chickens. Young chickens exist nor to have existed in hatchery (chicks, pullets, cockerels, capons) supply flocks during the preceding 12 which have been fed and watered and months and in which it has been deter- are less than 6 months of age. mined by the Service that: (A) All hatcheries within the State § 145.72 Participation. are qualified as ‘‘National Plan Hatch- Participating flocks of primary egg- eries’’ or have met equivalent require- type chickens, and the eggs and chicks ments for pullorum-typhoid control produced from them, shall comply with under official supervision; the applicable general provisions of (B) All hatchery supply flocks within subpart A of this part and the special the State are qualified as U.S. Pul- provisions of this subpart G. lorum-Typhoid Clean or have met (a) Started chickens shall lose their equivalent requirements for pullorum- identity under Plan terminology when typhoid control under official super- not maintained by Plan participants vision: Provided, That if other domes- under the conditions prescribed in ticated fowl, except waterfowl, are § 145.5(a). maintained on the same premises as (b) Hatching eggs produced by pri- the participating flock, freedom from mary breeding flocks shall be fumi- pullorum-typhoid infection shall be gated (see § 147.25 of this subchapter) or demonstrated by an official blood test otherwise sanitized. of each of these fowl; (c) Any nutritive material provided (C) All shipments of products other to chicks must be free of the avian than U.S. Pullorum-Typhoid Clean, or pathogens that are officially rep- equivalent, into the State are prohib- resented in the Plan disease classifica- ited; tions listed in § 145.10. (D) All persons performing poultry disease diagnostic services within the § 145.73 Terminology and classifica- State are required to report to the Offi- tion; flocks and products. cial State Agency within 48 hours the Participating flocks, and the eggs source of all poultry specimens from and chicks produced from them, which which S. pullorum or S. gallinarum is have met the respective requirements isolated; specified in this section, may be des- (E) All reports of any disease out- ignated by the following terms and the break involving a disease covered corresponding designs illustrated in under the Plan are promptly followed § 145.10: by an investigation by the Official

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State Agency to determine the origin (i) It is a flock in which all birds or of the infection; Provided, That if the a sample of at least 300 birds has been origin of the infection involves another tested for M. gallisepticum as provided State, or if there is exposure to poultry in § 145.14(b) when more than 4 months in another State from the infected of age: Provided, That to retain this flock, then officials administering the classification, a minimum of 150 birds National Poultry Improvement Plan shall be tested at intervals of not more will conduct an investigation; than 90 days: And provided further, That (F) All flocks found to be infected a sample comprised of fewer than 150 with pullorum or typhoid are quar- birds may be tested at any one time, if antined until marketed or destroyed all pens are equally represented and a under the supervision of the Official total of 150 birds is tested within each State Agency, or until subsequently 90-day period. blood tested following the procedure (ii) [Reserved] for reacting flocks as contained in (2) A participant handling U.S. M. § 145.14(a)(5), and all birds fail to dem- Gallisepticum Clean products shall onstrate pullorum or typhoid infection; handle only products of equivalent sta- (G) All poultry, including exhibition, tus. exotic, and game birds, but excluding (3) U.S. M. Gallisepticum Clean waterfowl, going to public exhibition chicks shall be boxed in clean boxes shall come from U.S. Pullorum-Ty- and delivered in trucks that have been phoid Clean or equivalent flocks, or cleaned and disinfected as described in have had a negative pullorum-typhoid § 147.24(a) of this subchapter. test within 90 days of going to public (d) U.S. S. Enteritidis Clean. This clas- exhibition; and sification is intended for primary egg- type breeders wishing to assure their (H) Discontinuation of any of the customers that the hatching eggs and conditions or procedures described in multiplier chicks produced are cer- paragraphs (b)(2)(i)(A) through tified free of Salmonella enteritidis. (b)(2)(i)(G) of this section, or the occur- (1) A flock and the hatching eggs and rence of repeated outbreaks of pul- chicks produced from it which have lorum or typhoid in poultry breeding met the following requirements as de- flocks within or originating within the termined by the Official State Agency: State shall be grounds for the Service (i) The flock originated from a U.S. to revoke its determination that such S. Enteritidis Clean flock, or meco- conditions and procedures have been nium from the chick boxes and a sam- met or complied with. Such action ple of chicks that died within 7 days shall not be taken until a thorough in- after hatching are examined bacterio- vestigation has been made by the Serv- logically for salmonella at an author- ice and the Official State Agency has ized laboratory. Cultures from positive been given an opportunity to present samples shall be serotyped. its views; and (ii) All feed fed to the flock shall (ii) In the primary breeding flock, a meet the following requirements: sample of 300 birds from flocks of more (A) Pelletized feed shall contain ei- than 300, and each bird in flocks of 300 ther no animal protein or only animal or less, has been officially tested for protein products produced under the pullorum-typhoid with no reactors: Animal Protein Products Industry Provided, That a bacteriological exam- (APPI) Salmonella Education/Reduction ination monitoring program acceptable Program. The protein products must to the Official State Agency and ap- have a minimum moisture content of proved by the Service may be used in 14.5 percent and must have been heated lieu of blood testing. throughout to a minimum temperature (c) U.S. M. Gallisepticum Clean. (1) A of 190 °F, or above, or to a minimum flock maintained in compliance with temperature of 165 °F for at least 20 the provisions of § 147.26 of this sub- minutes, or to a minimum temperature chapter and in which freedom from M. of 184 °F under 70 lbs. pressure during gallisepticum has been demonstrated the manufacturing process. under the criteria specified in para- (B) Mash feed may contain no animal graph (c)(1)(i) of this section. protein other than an APPI animal

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protein product supplement manufac- this subchapter. Cultures from positive tured in pellet form and crumbled: Pro- samples shall be serotyped. vided, That mash feed may contain (viii) Hatching eggs are collected as nonpelleted APPI animal protein prod- quickly as possible and are handled as uct supplements if the finished feed is described in § 147.22 of this subchapter treated with a salmonella control prod- and are sanitized or fumigated (see uct approved by the U.S. Food and § 147.25 of this subchapter). Drug Administration. (ix) Hatching eggs produced by the (iii) Feed shall be stored and trans- flock are incubated in a hatchery that ported in such a manner as to prevent is in compliance with the recommenda- possible contamination; tions in §§ 147.23 and 147.24(b) of this (iv) The flock is maintained in com- subchapter, and sanitized either by a pliance with §§ 147.21, 147.24(a), and procedure approved by the Official 147.26 of this subchapter. Rodents and State Agency or fumigated (see § 147.25 other pests should be effectively con- of this subchapter). trolled; (2) A flock shall not be eligible for (v) Environmental samples shall be this classification if Salmonella collected from the flock by an Author- enteritidis serotype enteritidis (SE) is ized Agent, as described in § 147.12 of isolated from a specimen taken from a this subchapter, when the flock is 2 to bird in the flock. Isolation of SE from 4 weeks of age. The samples shall be ex- an environmental or other specimen, as amined bacteriologically for group D described in paragraph (d)(1)(v) of this salmonella at an authorized labora- section, will require bacteriological ex- tory. Cultures from positive samples amination for SE in an authorized lab- shall be serotyped. The Authorized oratory, as described in § 147.11(a) of Agent shall also collect samples every this subchapter, of a random sample of 30 days after the first sample has been 60 live birds from a flock of 5,000 birds collected. or more, or 30 live birds from a flock (vi) If a Salmonella vaccine is used with fewer than 5,000 birds. If only one that causes positive reactions with pullorum-typhoid antigen, one of the fol- specimen is found positive for SE, the lowing options must be utilized. participant may request bacterio- (A) Administer the vaccine after the logical examination of a second sam- pullorum-typhoid testing is done as de- ple, equal in size to the first sample, scribed in paragraph (d)(1)(vii) of this from the flock. If no SE is recovered section. from any of the specimens in the sec- (B) If an injectable bacterin or live ond sample, the flock will be eligible vaccine that does not spread is used, for the classification. keep a sample of 350 birds unvaccinated (3) A non-vaccinated flock shall be el- and banded for identification until the igible for this classification if SE is flock reaches at least 4 months of age. isolated from an environmental sample Following negative serological and collected from the flock in accordance bacteriological examinations as de- with paragraph (d)(1)(v) of this section: scribed in paragraph (d)(1)(vii) of this Provided, That testing is conducted in section, vaccinate the banded, non-vac- accordance with paragraph (d)(1)(vii) of cinated birds. this section each 30 days and no posi- (vii) Blood samples from 300 non-vac- tive samples are found. cinated birds as described in paragraph (4) In order for a hatchery to sell (d)(1)(vi) of this section shall be tested products of this classification, all prod- with either pullorum antigen or by a ucts handled shall meet the require- federally licensed Salmonella enteritidis ments of the classification. enzyme-linked immunosorbent assay (5) This classification may be re- (ELISA) test when the flock is more voked by the Official State Agency if than 4 months of age. All birds with the participant fails to follow rec- positive or inconclusive reactions, up ommended corrective measures. The to a maximum of 25 birds, shall be sub- Official State Agency shall not revoke mitted to an authorized laboratory and the participant’s classification until examined for the presence of group D the participant has been given an op- salmonella, as described in § 147.11 of portunity for a hearing in accordance

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with rules of practice adopted by the birds is tested within each 90-day pe- Official State Agency. riod; or (e) U.S. M. Synoviae Clean. (1) A flock (iii) The flock is tested as provided in maintained in compliance with the § 145.14(d) at intervals of 30 days or less provisions of § 147.26 of this subchapter and found to be negative, and a total of and in which freedom from M. synoviae 30 samples are collected and tested has been demonstrated under the cri- within each 90-day period; and teria specified in paragraph (e)(1)(i) of (2) During each 90-day period, all pri- this section. mary spent fowl, up to a maximum of (i) It is a flock in which a minimum 30, must be tested serologically and of 300 birds has been tested for M. found negative within 21 days prior to synoviae as provided in § 145.14(b) when movement to slaughter. more than 4 months of age: Provided, [72 FR 1420, Jan. 12, 2007, as amended at 76 That to retain this classification, a FR 15794, Mar. 22, 2011] sample of at least 150 birds shall be tested at intervals of not more than 90 Subpart H—Special Provisions for days: And provided further, That a sam- Primary Meat-Type Chicken ple comprised of fewer than 150 birds Breeding Flocks and Prod- may be tested at any one time if all ucts pens are equally represented and a total of 150 birds is tested within each 90-day period. SOURCE: 72 FR 1422, Jan. 12, 2007, unless otherwise noted. (ii) [Reserved] (2) A participant handling U.S. M. § 145.81 Definitions. Synoviae Clean products shall handle Except where the context otherwise only products of equivalent status. requires, for the purposes of this sub- (3) U.S. M. Synoviae Clean chicks part the following terms shall be con- shall be boxed in clean boxes and deliv- strued, respectively, to mean: ered in trucks that have been cleaned Chicks. Newly hatched chickens. and disinfected as described in Primary meat-type chicken breeding § 147.24(a) of this subchapter. flocks. Foundation flocks that are com- (f) U.S. Avian Influenza Clean. This posed of pedigree, great-grandparent, program is intended to be the basis and grandparent stock that has been from which the breeding-hatchery in- developed for meat production and are dustry may conduct a program for the maintained for the principal purpose of prevention and control of avian influ- producing multiplier breeding chicks enza. It is intended to determine the used to produce commercial broilers. presence of avian influenza in primary Started chickens. Young chickens breeding chickens through routine sur- (chicks, pullets, cockerels, capons) veillance of each participating breed- which have been fed and watered and ing flock. A flock and the hatching are less than 6 months of age. eggs and chicks produced from it will qualify for this classification when the § 145.82 Participation. Official State Agency determines that Participating flocks of primary they have met the following require- meat-type chickens, and the eggs and ments: chicks produced from them, shall com- (1) It is a primary breeding flock in ply with the applicable general provi- which a minimum of 30 birds have been sions of subpart A of this part and the tested negative for antibodies to avian special provisions of this subpart H. influenza when more than 4 months of (a) Started chickens shall lose their age. To retain this classification: identity under Plan terminology when (i) A sample of at least 30 birds must not maintained by Plan participants be tested negative at intervals of 90 under the conditions prescribed in days; or § 145.5(a). (ii) A sample of fewer than 30 birds (b) Hatching eggs produced by pri- may be tested, and found to be nega- mary breeding flocks shall be fumi- tive, at any one time if all pens are gated (see § 147.25 of this subchapter) or equally represented and a total of 30 otherwise sanitized.

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(c) Any nutritive material provided demonstrated by an official blood test to chicks must be free of the avian of each of these fowl; pathogens that are officially rep- (C) All shipments of products other resented in the Plan disease classifica- than U.S. Pullorum-Typhoid Clean, or tions listed in § 145.10. equivalent, into the State are prohibited; § 145.83 Terminology and classifica- (D) All persons performing poultry tion; flocks and products. disease diagnostic services within the Participating flocks, and the eggs State are required to report to the Offi- and chicks produced from them, which cial State Agency within 48 hours the have met the respective requirements source of all poultry specimens from specified in this section, may be des- which S. pullorum or S. gallinarum is ignated by the following terms and the isolated; corresponding designs illustrated in (E) All reports of any disease out- § 145.10: break involving a disease covered (a) [Reserved] under the Plan are promptly followed by an investigation by the Official (b) U.S. Pullorum-Typhoid Clean. A State Agency to determine the origin flock in which freedom from pullorum of the infection; Provided, That if the and typhoid has been demonstrated to origin of the infection involves another the Official State Agency under the State, or if there is exposure to poultry criteria in paragraph (b)(1) or (b)(2) of in another State from the infected this section: Provided, That a flock flock, then officials administering the qualifying by means of a blood test National Poultry Improvement Plan shall be tested within the past 12 will conduct an investigation; months, except that the retesting of a (F) All flocks found to be infected participating flock which is retained with pullorum or typhoid are quar- for more than 12 months shall be con- antined until marketed or destroyed ducted a minimum of 4 weeks after the under the supervision of the Official induction of molt. (See § 145.14 relating State Agency, or until subsequently to the official blood test where applica- blood tested following the procedure ble.) for reacting flocks as contained in (1) It has been officially blood tested § 145.14(a)(5) of this subchapter, and all with no reactors. birds fail to demonstrate pullorum or (2) It is a primary breeding flock that typhoid infection; meets the following criteria: (G) All poultry, including exhibition, (i) The primary breeding flock is lo- exotic, and game birds, but excluding cated in a State in which pullorum dis- waterfowl, going to public exhibition ease or fowl typhoid is not known to shall come from U.S. Pullorum-Ty- exist nor to have existed in hatchery phoid Clean or equivalent flocks, or supply flocks within the State during have had a negative pullorum-typhoid the preceding 12 months and in which test within 90 days of going to public it has been determined by the Service exhibition; and that: (H) Discontinuation of any of the (A) All hatcheries within the State conditions or procedures described in are qualified as ‘‘National Plan Hatch- paragraphs (b)(2)(i)(A) through eries’’ or have met equivalent require- (b)(2)(i)(G) of this section, or the occur- ments for pullorum-typhoid control rence of repeated outbreaks of pul- under official supervision; lorum or typhoid in poultry breeding (B) All hatchery supply flocks within flocks within or originating within the the State are qualified as U.S. Pul- State shall be grounds for the Service lorum-Typhoid Clean or have met to revoke its determination that such equivalent requirements for pullorum- conditions and procedures have been typhoid control under official super- met or complied with. Such action vision: Provided, That if other domes- shall not be taken until a thorough in- ticated fowl, except waterfowl, are vestigation has been made by the Serv- maintained on the same premises as ice and the Official State Agency has the participating flock, freedom from been given an opportunity to present pullorum-typhoid infection shall be its views; and

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(ii) In the primary breeding flock, a (3) U.S. M. Synoviae Clean chicks sample of 300 birds from flocks of more shall be boxed in clean boxes and deliv- than 300, and each bird in flocks of 300 ered in trucks that have been cleaned or less, has been officially tested for and disinfected as described in pullorum-typhoid with no reactors: § 147.24(a) of this subchapter. Provided, That a bacteriological exam- (e) U.S. S. Enteritidis Clean. This clas- ination monitoring program acceptable sification is intended for primary to the Official State Agency and ap- meat-type breeders wishing to assure proved by the Service may be used in their customers that the chicks pro- lieu of blood testing. duced are certified free of Salmonella (c) U.S. M. Gallisepticum Clean. (1) A enteritidis. flock maintained in compliance with (1) A flock and the hatching eggs and the provisions of § 147.26 of this sub- chicks produced from it shall be eligi- chapter and in which freedom from M. ble for this classification if they meet gallisepticum has been demonstrated the following requirements, as deter- under the criteria specified in para- mined by the Official State Agency: graph (c)(1)(i) of this section. (i) The flock originated from a U.S. (i) It is a flock in which all birds or S. Enteritidis Clean flock, or one of the a sample of at least 300 birds has been following samples has been examined tested for M. gallisepticum as provided bacteriologically for S. enteritidis at an in § 145.14(b) of this subchapter when authorized laboratory and any group D more than 4 months of age: Provided, Salmonella samples have been That to retain this classification, a serotyped: minimum of 40 birds shall be tested at (A) A 25-gram sample of meconium intervals of not more than 28 days, and from the chicks in the flock collected a total of at least 150 birds shall be and cultured as described in tested within each 90-day period. § 147.12(a)(5) of this subchapter; or (B) A sample of chick papers col- (ii) [Reserved] lected and cultured as described in (2) A participant handling U.S. M. § 147.12(c) of this subchapter; or Gallisepticum Clean products must (C) A sample of 10 chicks that died handle only products of equivalent sta- within 7 days after hatching. tus. (ii) All feed fed to the flock meets the (3) U.S. M. Gallisepticum Clean following requirements: chicks shall be boxed in clean boxes (A) Pelletized feed must have a min- and delivered in trucks that have been imum moisture content of 14.5 percent cleaned and disinfected as described in and must have been heated throughout § 147.24(a) of this subchapter. to a minimum temperature of 190 °F, or (d) U.S. M. Synoviae Clean. (1) A flock to a minimum temperature of 165 °F for maintained in compliance with the at least 20 minutes, or to a minimum provisions of § 147.26 of this subchapter temperature of 184 °F under 70 lbs. and in which freedom from M. synoviae pressure during the manufacturing has been demonstrated under the cri- process; teria specified in paragraph (d)(1)(i) of (B) Mash feed may contain animal this section. protein if the finished feed is treated (i) It is a flock in which all birds or with a salmonella control product ap- a sample of at least 300 birds has been proved by the U.S. Food and Drug Ad- tested for M. synoviae as provided in ministration. § 145.14(b) of this subchapter when more (C) All feed is stored and transported than 4 months of age: Provided, That to in such a manner as to prevent possible retain this classification, a sample of contamination. at least 40 birds shall be tested at in- (iii) The flock is maintained in com- tervals of not more than 28 days, and a pliance with §§ 147.21, 147.24(a), and total of at least 150 birds shall be test- 147.26 of this subchapter. ed within each 90-day period. (iv) Environmental samples are col- (ii) [Reserved] lected from the flock by or under the (2) A participant handling U.S. M. supervision of an Authorized Agent, as Synoviae Clean products shall handle described in § 147.12 of this subchapter, only products of equivalent status. when the flock reaches 4 months of age

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and every 30 days thereafter. The envi- (4) In order for a hatchery to sell ronmental samples shall be examined products of this classification, all prod- bacteriologically for group D sal- ucts handled by the hatchery must monella at an authorized laboratory, meet the requirements of this para- and cultures from group D positive graph. samples shall be serotyped. (5) This classification may be re- (v) Blood samples from 300 birds from voked by the Official State Agency if the flock are officially tested with pul- the participant fails to follow rec- lorum antigen when the flock is at ommended corrective measures. The least 4 months of age. All birds with Official State Agency shall not revoke positive or inconclusive reactions, up the participant’s classification until to a maximum of 25 birds, shall be sub- the participant has been given an op- mitted to an authorized laboratory and portunity for a hearing in accordance examined for the presence of group D with rules of practice adopted by the salmonella in accordance with §§ 147.10 Official State Agency. and 147.11 of this subchapter. Cultures (6) A pedigree, experimental, or from group D positive samples shall be great-grandparent flock that is re- serotyped. moved from the U.S. S. Enteritidis (vi) Hatching eggs produced by the Clean program may be reinstated flock are collected as quickly as pos- whenever the following conditions are sible and are handled as described in met: § 147.22 of this subchapter. (i) The owner attests that corrective measures have been implemented, (vii) Hatching eggs produced by the which may include one or more of the flock are incubated in a hatchery that following: is in compliance with the recommenda- (A) Test and slaughter infected birds tions in §§ 147.23 and 147.24(b) of this based on blood tests of every bird in subchapter, and the hatchery must the flock, with either pullorum antigen have been sanitized either by a proce- or by a federally licensed Salmonella dure approved by the Official State enteritidis enzyme-linked Agency or by fumigation. immunosorbent assay (ELISA) test (2) If Salmonella enteritidis serotype when the flock is more than 4 months enteritidis (SE) is isolated from a speci- of age. men taken from a bird in the flock, ex- (B) Perform other corrective actions cept as provided in paragraph (e)(3) of including, but not limited to, vaccina- this section, the flock shall not be eli- tion, medication, cleaning and disinfec- gible for this classification. tion of houses, rodent control, and (3) If SE is isolated from an environ- movement of uninfected birds to prem- mental sample collected from the flock ises that have been determined to be in accordance with paragraph (e)(1)(iv) environmentally negative for S. of this section, 25 randomly selected enteritidis as described in § 147.12(a) of live birds from the flock and/or 500 this subchapter. cloacal swabs collected in accordance (C) One hundred percent of blood with § 147.12(a)(2) of this subchapter samples from the birds moved to the must be bacteriologically examined for clean premises are tested negative for SE as described in § 147.11 of this sub- Salmonella pullorum and group D Sal- chapter. If only 1 bird from the 25-bird monella. All birds with positive or in- sample is found positive for SE, the conclusive reactions, up to a maximum participant may request bacterio- of 25 birds, shall be submitted to an au- logical examination of a second 25-bird thorized laboratory and examined for sample from the flock. If no SE is re- the presence of group D Salmonella, as covered from any of the specimens in described in § 147.11 of this subchapter. the second sample, the flock will be eli- Cultures from positive samples shall be gible for the classification and will re- serotyped. main eligible for this classification if (D) Two consecutive environmental the flock is tested in accordance with drag swabs taken at the clean premises paragraph (e)(1)(v) of this section each collected as specified in § 147.12(a) of 30 days and no positive samples are this subchapter 4 weeks apart are nega- found. tive for S. enteritidis.

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(E) Other corrective measures at the tory for Salmonella shall examine the discretion of the Official State Agency. environmental samples bacterio- (ii) Following reinstatement, a flock logically. All Salmonella isolates from a will remain eligible for this classifica- flock shall be serogrouped and shall be tion if the flock is tested in accordance reported to the Official State Agency with paragraph (e)(1)(v) of this section on a monthly basis; every 30 days and no positive samples (vii) Owners of flocks may vaccinate are found and the flock meets the re- with a paratyphoid vaccine: Provided, quirements set forth in § 145.83(e). That a sample of 350 birds, which will (f) U.S. Salmonella Monitored. This be banded for identification, shall re- program is intended to be the basis main unvaccinated until the flock from which the breeding-hatching in- reaches at least 4 months of age to dustry may conduct a program for the allow for the serological testing re- prevention and control of salmonel- quired under paragraph (f)(1)(vi) of this losis. It is intended to reduce the inci- section. dence of Salmonella organisms in hatch- (viii) Any flock entering the producing eggs and chicks through an effec- tion period that is in compliance with tive and practical sanitation program all the requirements of § 145.83(f) with at the breeder farm and in the hatch- no history of Salmonella isolations shall ery. This will afford other segments of be considered ‘‘Salmonella negative’’ the poultry industry an opportunity to and may retain this definition as long reduce the incidence of Salmonella in as no environmental or bird Salmonella their products. isolations are identified and confirmed (1) A flock and the hatching eggs and from the flock or flock environment by chicks produced from it that have met sampling on 4 separate collection dates the following requirements, as deter- over a minimum of a 2-week period. mined by the Official State Agency. Sampling and testing must be per- (i) The flock is maintained in compli- formed as described in paragraph ance with §§ 147.21, 147.24(a), and 147.26 (f)(1)(vi) of this section. An of this subchapter; unconfirmed environmental Salmonella (ii) If feed contains animal protein, isolation shall not change this Sal- the protein products must have a min- monella negative status. imum moisture content of 14.5 percent (2) The Official State Agency may and must have been heated throughout use the procedures described in § 147.14 to a minimum temperature of 190 °F or of this subchapter to monitor the effec- above, or to a minimum temperature of tiveness of the egg sanitation prac- 165 °F for at least 20 minutes, or to a tices. minimum temperature of 184 °F under (3) In order for a hatchery to sell 70 lbs. pressure during the manufac- products of paragraphs (f)(1)(i) through turing process; (f)(1)(vii) of this section, all products (iii) Feed shall be stored and trans- handled shall meet the requirements of ported in a manner to prevent possible the classification. contamination; (4) This classification may be re- (iv) Chicks shall be hatched in a voked by the Official State Agency if hatchery meeting the requirements of the participant fails to follow rec- §§ 147.23 and 147.24(b) of this subchapter ommended corrective measures. and sanitized or fumigated (see § 147.25 (g) U.S. Avian Influenza Clean. This of this subchapter). program is intended to be the basis (v) An Authorized Agent shall take from which the breeding-hatchery in- environmental samples from the hatch- dustry may conduct a program for the ery every 30 days; i.e., meconium or prevention and control of avian influ- chick papers. An authorized laboratory enza. It is intended to determine the for Salmonella shall examine the sam- presence of avian influenza in primary ples bacteriologically; breeding chickens through routine sur- (vi) An Authorized Agent shall take veillance of each participating breed- environmental samples as described in ing flock. A flock and the hatching § 147.12 of this subchapter from each eggs and chicks produced from it will flock at 4 months of age and every 30 qualify for this classification when the days thereafter. An authorized labora- Official State Agency determines that

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they have met the following require- (a) Started poultry shall lose their ments: identity under Plan terminology when (1) It is a primary breeding flock in not maintained by Plan participants which a minimum of 30 birds have been under the conditions prescribed in tested negative for antibodies to avian § 145.5(a). influenza when more than 4 months of (b) Hatching eggs produced by pri- age. To retain this classification: mary breeding flocks shall be fumi- (i) A sample of at least 30 birds must gated (see § 147.25 of this chapter) or be tested negative at intervals of 90 otherwise sanitized. days; or (c) Any nutritive material provided (ii) A sample of fewer than 30 birds to baby poultry must be free of the may be tested, and found to be nega- avian pathogens that are officially rep- tive, at any one time if all pens are resented in the Plan disease classifica- equally represented and a total of 30 tions listed in § 145.10. birds is tested within each 90-day period; or § 145.93 Terminology and classifica- (iii) The flock is tested as provided in tion; flocks and products. § 145.14(d) at intervals of 30 days or less Participating flocks, and the eggs and found to be negative, and a total of and baby poultry produced from them, 30 samples are collected and tested that have met the respective require- within each 90-day period; and ments specified in this section may be (2) During each 90-day period, all pri- designated by the following terms and mary spent fowl, up to a maximum of the corresponding designs illustrated 30, must be tested serologically and in § 145.10. found negative within 21 days prior to movement to slaughter. (a) [Reserved] (b) U.S. Pullorum-Typhoid Clean. A [72 FR 1422, Jan. 12, 2007, as amended at 76 flock in which freedom from pullorum FR 15794, Mar. 22, 2011] and typhoid has been demonstrated to the Official State Agency under the Subpart I—Special Provisions for criteria in one of the following para- Meat-Type Waterfowl Breed- graphs (b)(1) through (b)(5) of this sec- ing Flocks and Products tion (See § 145.14 relating to the official blood test where applicable.): SOURCE: 76 FR 15794, Mar. 22, 2011, unless (1) It has been officially blood tested otherwise noted. within the past 12 months with no reactors. § 145.91 Definitions. (2) It is a multiplier breeding flock, Except where the context otherwise or a breeding flock composed of prog- requires, for the purposes of this sub- eny of a primary breeding flock which part the following term shall be con- is intended solely for the production of strued to mean: multiplier breeding flocks, and meets Meat-type waterfowl breeding flocks. the following specifications as deter- Flocks of domesticated duck or goose mined by the Official State Agency and that are composed of stock that has the Service: been developed and is maintained for (i) The flock is located in a State the primary purpose of producing baby where all persons performing poultry poultry that will be raised under con- disease diagnostic services within the finement for the primary purpose of State are required to report to the Offi- producing meat for human consump- cial State Agency within 48 hours the tion. source of all poultry specimens from which S. pullorum or S. gallinarum is § 145.92 Participation. isolated; Participating flocks of meat-type wa- (ii) The flock is composed entirely of terfowl and the eggs and baby poultry birds that originated from U.S. Pul- produced from them shall comply with lorum-Typhoid Clean breeding flocks the applicable general provisions of or from flocks that met equivalent re- subpart A of this part and the special quirements under official supervision; provisions of this subpart I. and

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(iii) The flock is located on a prem- (v) All reports of any disease out- ises where a flock not classified as U.S. break involving a disease covered Pullorum-Typhoid Clean was located under the Plan are promptly followed the previous year; Provided, that an by an investigation by the Official Authorized Testing Agent must blood State Agency to determine the origin test up to 300 birds per flock, as de- of the infection; Provided, That if the scribed in § 145.14, if the Official State origin of the infection involves another Agency determines that the flock has State, or if there is exposure to poultry been exposed to pullorum-typhoid. In in another State from the infected making determinations of exposure and flock, then the National Poultry Im- setting the number of birds to be blood provement Plan will conduct an inves- tested, the Official State Agency shall tigation; evaluate the results of any blood tests, (vi) All flocks found to be infected described in § 145.14(a)(1), that were per- with pullorum or typhoid are quar- formed on an unclassified flock located antined until marketed or destroyed on the premises during the previous under the supervision of the Official year; the origins of the unclassified State Agency, or until subsequently flock; and the probability of contacts blood tested, following the procedure between the flock for which qualifica- for reacting flocks as contained in tion is being sought and infected wild § 145.14(a)(5), and all birds fail to dem- birds, contaminated feed or waste, or onstrate pullorum or typhoid infection; birds, equipment, supplies, or personnel (vii) All poultry, including exhi- from flocks infected with pullorum-ty- bition, exotic, and game birds, but ex- phoid. cluding waterfowl, going to public ex- (3) It is a multiplier breeding flock hibition shall come from U.S. Pul- that originated from U.S. Pullorum- lorum-Typhoid Clean or equivalent Typhoid Clean breeding flocks or from flocks, or have had a negative pul- flocks that met equivalent require- lorum-typhoid test within 90 days of ments under official supervision, and is going to public exhibition; located in a State in which it has been (viii) Discontinuation of any of the determined by the Service that: conditions or procedures described in paragraphs (a)(3)(i), (ii), (iii), (iv), (v), (i) All hatcheries within the State (vi), and (vii) of this section, or the oc- are qualified as ‘‘National Plan Hatch- currence of repeated outbreaks of pul- eries’’ or have met equivalent require- lorum or typhoid in poultry breeding ments for pullorum-typhoid control flocks within or originating within the under official supervision; State shall be grounds for the Service (ii) All hatchery supply flocks within to revoke its determination that such the State are qualified as U.S. Pul- conditions and procedures have been lorum-Typhoid Clean or have met met or complied with. Such action equivalent requirements for pullorum- shall not be taken until a thorough in- typhoid control under official super- vestigation has been made by the Serv- vision: Provided, That if other domes- ice and the Official State Agency has ticated fowl are maintained on the been given an opportunity to present same premises as the participating its views. flock, freedom from pullorum-typhoid (4) It is a multiplier breeding flock infection shall be demonstrated by an located in a State which has been de- official blood test of each of these fowl; termined by the Service to be in com- (iii) All shipments of products other pliance with the provisions of para- than U.S. Pullorum-Typhoid Clean, or graph (a)(3) of this section, and in equivalent, into the State are prohib- which pullorum disease or fowl typhoid ited; is not known to exist nor to have ex- (iv) All persons performing poultry isted in hatchery supply flocks within disease diagnostic services within the the State during the preceding 24 State are required to report to the Offi- months. cial State Agency within 48 hours the (5) It is a primary breeding flock lo- source of all poultry specimens from cated in a State determined to be in which S. pullorum or S. gallinarum is compliance with the provisions of para- isolated; graph (a)(4) of this section, and in

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which a sample of 300 birds from flocks (ii) A sample of fewer than 30 birds of more than 300, and each bird in may be tested, and found to be nega- flocks of 300 or less, has been officially tive, at any one time if all pens are tested for pullorum-typhoid within the equally represented and a total of 30 past 12 months with no reactors: Pro- birds are tested within each 180-day pe- vided, That when a flock is a primary riod. breeding flock located in a State which (3) During each 90-day period, all has been deemed to be a U.S. Pullorum- spent fowl, up to a maximum of 30, Typhoid Clean State for the past 3 must be tested serologically and found years, and during which time no isola- negative within 21 days prior to move- tion of pullorum or typhoid has been ment to slaughter. made that can be traced to a source in that State, a bacteriological examina- § 145.94 Terminology and classification monitoring program or a sero- tion; States. logical examination monitoring program acceptable to the Official State (a) U.S. Pullorum-Typhoid Clean State. Agency and approved by the Service (1) A State will be declared a U.S. Pul- may be used in lieu of annual blood lorum-Typhoid Clean State when it has testing. been determined by the Service that: (c) U.S. H5/H7 Avian Influenza Clean. (i) The State is in compliance with This program is intended to be the the provisions contained in basis from which the breeding-hatchery §§ 145.23(b)(3)(i) through (vii), industry may conduct a program for 145.33(b)(3)(i) through (vii), the prevention and control of the H5/H7 145.43(b)(3)(i) through (vi), 145.53(b)(3)(i) subtypes of avian influenza. It is in- through (vii), 145.73(b)(2)(i), tended to determine the presence of the 145.83(b)(2)(i), and 145.93(b)(3)(i) through H5/H7 subtypes of avian influenza in (vii). meat-type waterfowl breeding flocks (ii) No pullorum disease or fowl ty- through routine surveillance of each phoid is known to exist nor to have ex- participating breeding flock. A flock, isted in hatchery supply flocks within and the hatching eggs and baby poultry the State during the preceding 12 produced from it, will qualify for this months: Provided, That pullorum dis- classification when the Official State ease or fowl typhoid found within the Agency determines that it has met one of the following requirements: preceding 24 months in waterfowl, exhi- (1) It is a primary breeding flock in bition poultry, and game bird breeding which a minimum of 30 birds have been flocks will not prevent a State that is tested negative to the H5/H7 subtypes otherwise eligible from qualifying. of avian influenza as provided in (2) Discontinuation of any of the con- § 145.14(d) when more than 4 months of ditions described in paragraph (a)(1)(i) age. To retain this classification: of this section, or repeated outbreaks (i) A sample of at least 30 birds must of pullorum or typhoid occur in hatch- be tested and found to be negative at ery supply flocks described in para- intervals of 90 days; or graph (a)(1)(ii) of this section, or if an (ii) A sample of fewer than 30 birds infection spreads from the originating may be tested, and found to be nega- premises, the Service shall have tive, at any one time if all pens are grounds to revoke its determination equally represented and a total of 30 that the State is entitled to this classi- birds are tested within each 90-day pe- fication. Such action shall not be riod. taken until a thorough investigation (2) It is a multiplier breeding flock in has been made by the Service and the which a minimum of 30 birds have been Official State Agency has been given tested negative to the H5/H7 subtypes an opportunity for a hearing in accord- of avian influenza as provided in ance with rules of practice adopted by § 145.14(d) when more than 4 months of the Administrator. age. To retain this classification: (i) A sample of at least 30 birds must (b) [Reserved] be tested negative at intervals of 180 days; or

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PART 146—NATIONAL POULTRY IM- 146.53 Terminology and classification; PROVEMENT PLAN FOR COM- slaughter plants and premises. MERCIAL POULTRY AUTHORITY: 7 U.S.C. 8301–8317; 7 CFR 2.22, 2.80, and 371.4.

Subpart A—General Provisions SOURCE: 71 FR 56328, Sept. 26, 2006, unless otherwise noted. Sec. 146.1 Definitions. 146.2 Administration. Subpart A—General Provisions 146.3 Participation. 146.4 General provisions for all partici- § 146.1 Definitions. pating flocks and slaughter plants. Except where the context otherwise 146.5 Specific provisions for all participating flocks. requires, for the purposes of this sub- 146.6 Specific provisions for participating part the following terms shall be con- slaughter plants. strued, respectively, to mean: 146.7 Terminology and classification; gen- Administrator. The Administrator, eral. Animal and Plant Health Inspection 146.8 Terminology and classification; Service, or any person authorized to slaughter plants. act for the Administrator. 146.9 Terminology and classification; flocks, products, and States. Affiliated flock. A meat-type flock 146.10 Supervision. that is owned by or has an agreement 146.11 Inspections. to participate in the Plan with a 146.12 Debarment from participation. slaughter plant and that participates 146.13 Testing. in the Plan through that slaughter 146.14 Diagnostic surveillance program for plant. H5/H7 low pathogenic avian influenza. Animal and Plant Health Inspection Subpart B—Special Provisions for Service (APHIS). The Animal and Plant Commercial Table-Egg Layer Flocks Health Inspection Service of the U.S. Department of Agriculture. 146.21 Definitions. Authorized Agent. Any person des- 146.22 Participation. ignated under § 146.10(a) to perform 146.23 Terminology and classification; functions under this part. flocks and products. 146.24 Terminology and classification; Authorized laboratory. An authorized States. laboratory is a laboratory that meets the requirements of § 147.51 and is thus Subpart C—Special Provisions for Meat- qualified to perform the assays de- Type Chicken Slaughter Plants scribed in part 147 of this subchapter. Classification. A designation earned 146.31 Definitions. 146.32 Participation. by participation in a Plan program. 146.33 Terminology and classification; Commercial meat-type flock. All of the meat-type chicken slaughter plants. meat-type chickens, meat-type turkeys, commercial upland game birds, Subpart D—Special Provisions for Meat- or commercial waterfowl on one farm. Type Turkey Slaughter Plants However, at the discretion of the Offi- cial State Agency, any group of poul- 146.41 Definitions. 146.42 Participation. try which is segregated from another 146.43 Terminology and classification; group in a manner sufficient to prevent meat-type turkey slaughter plants. the transmission of H5/H7 LPAI and 146.44 Terminology and classification; has been so segregated for a period of States. at least 21 days may be considered as a separate flock. Subpart E—Special Provisions for Commer- Commercial table-egg layer flock. All cial Upland Game Birds, Commercial table-egg layers of common age or pul- Waterfowl, Raised-for-Release Upland let source on one premises. Game Birds, and Raised-for-Release Commercial table-egg layer premises. A Waterfowl farm containing contiguous flocks of 146.51 Definitions. commercial table-egg layers under 146.52 Participation. common ownership.

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Commercial table-egg layer pullet flock. identified, viral antigen or viral RNA A table-egg layer flock prior to the specific to the H5 or H7 subtype of AI onset of egg production. virus has been detected, or antibodies Cooperating State Agency. Any State to the H5 or H7 subtype of AI virus authority recognized by the Depart- have been detected may only be made ment to cooperate in the administra- by the National Veterinary Services tion of the provisions of part 56 of this Laboratories. chapter. This may include the State Official State Agency. The State au- animal health authority or the Official thority recognized by the Department State Agency. to cooperate in the administration of Department. The U.S. Department of the Plan. Agriculture. Person. A natural person, firm, or Domesticated. Propagated and main- corporation. tained under the control of a person. Plan. The provisions of the National Equivalent. Requirements which are Poultry Improvement Plan contained equal to or exceed the program, condi- in this part. tions, criteria, or classifications with Poultry. Domesticated chickens and which they are compared, as deter- turkeys that are bred for the primary mined by the Official State Agency and purpose of producing eggs or meat. with the concurrence of the Service. Program. Management, sanitation, H5/H7 low pathogenic avian influenza testing, and monitoring procedures (LPAI). An infection of poultry caused which, if complied with, will qualify, by an influenza A virus of H5 or H7 and maintain qualification for, des- subtype that has an intravenous patho- ignation of a flock, a slaughter plant, genicity index in 6-week-old chickens or a State by an official Plan classi- less than 1.2 or less than 75 percent fication and illustrative design, as de- mortality in 4- to 8-week-old chickens scribed in § 146.9 of this part. infected intravenously, or an infection Service. The Animal and Plant Health with influenza A viruses of H5 or H7 Inspection Service of the U.S. Depart- subtype with a cleavage site that is not ment of Agriculture. consistent with a previously identified State. Any of the States, the District highly pathogenic avian influenza of Columbia, the Commonwealth of virus. Puerto Rico, Guam, the Common- H5/H7 LPAI virus infection (infected). wealth of the Northern Mariana Is- (1) Poultry will be considered to be in- lands, the Virgin Islands of the United fected with H5/H7 LPAI for the pur- States, or any territory or possession poses of this part if: of the United States. (i) H5/H7 LPAI virus has been iso- State Inspector. Any person employed lated and identified as such from poul- or authorized under § 146.10(b) to per- try; or form functions under this part. (ii) Viral antigen or viral RNA spe- United States. All of the States. cific to the H5 or H7 subtype of AI virus [71 FR 56328, Sept. 26, 2006, as amended at 74 has been detected in poultry; or FR 14715, Apr. 1, 2009; 75 FR 10658, Mar. 9, (iii) Antibodies to the H5 or H7 2010; 76 FR 15796, Mar. 22, 2011] subtype of the AI virus that are not a consequence of vaccination have been § 146.2 Administration. detected in poultry. If vaccine is used, (a) The Department cooperates methods should be used to distinguish through a Memorandum of Under- vaccinated birds from birds that are standing with the Official State Agen- both vaccinated and infected. In the cy in the administration of the Plan. In case of isolated serological positive re- the Memorandum of Understanding, sults, H5/H7 LPAI infection may be the Official State Agency must des- ruled out on the basis of a thorough ep- ignate a contact representative to idemiological investigation that does serve as a liaison between the Service not demonstrate further evidence of and the Official State Agency. H5/H7 LPAI infection, as determined by (b) The administrative procedures APHIS. and decisions of the Official State (2) The official determination that Agency are subject to review by the H5/H7 LPAI virus has been isolated and Service. The Official State Agency

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shall carry out the administration of and practices are adequate for carrying the Plan within the State according to out the relevant special provisions of the applicable provisions of the Plan this part and has signed an agreement and the Memorandum of Under- with the Official State Agency to com- standing. ply with the relevant special provisions (c)(1) An Official State Agency may of this part. accept for participation a commercial (b) Each participant shall comply table-egg layer flock or a commercial with the Plan throughout the oper- meat-type flock (including an affiliated ating year, or until released by the Of- flock) located in another participating ficial State Agency. State under a mutual understanding (c) A participating slaughter plant and agreement, in writing, between the shall participate with all of the com- two Official State Agencies regarding mercial upland game bird, commercial conditions of participation and super- waterfowl, meat-type chicken and/or vision. meat-type turkey flocks that are proc- (2) An Official State Agency may ac- essed at the facility, including affili- cept for participation a commercial ated flocks. Affiliated flocks must par- table-egg layer flock or a commercial ticipate through a written agreement meat-type flock (including an affiliated with a participating slaughter plant flock) located in a State that does not that is approved by the Official State participate in the Plan under a mutual Agency. understanding and agreement, in writ- (d) Participation in the Plan shall en- ing, between the owner of the flock and title the participant to use the Plan the Official State Agency regarding emblem reproduced as follows: conditions of participation and supervision. (d) The Official State Agency of any State may adopt regulations applicable to the administration of the Plan in such State further defining the provisions of the Plan or establishing higher standards, compatible with the Plan. (e) An authorized laboratory will follow the laboratory protocols outlined in part 147 of this chapter when determining the status of a participating flock with respect to an official Plan classification. (f) Cooperating State Agencies will be responsible for making the determination to request Federal assistance under part 56 of this chapter in the event of an outbreak of H5/H7 LPAI. [71 FR 56328, Sept. 26, 2006, as amended at 74 FR 14716, Apr. 1, 2009; 75 FR 10658, Mar. 9, 2010]

§ 146.3 Participation. (a) Any table-egg producer, raised- for-release upland game bird premises, (e) Participation in the NPIP by com- and raised-for-release waterfowl prem- mercial table-egg layers will cease ises and any commercial upland game after September 26, 2008 unless the ma- bird, commercial waterfowl, meat-type jority of the commercial table-egg chicken or meat-type turkey slaughter layer delegates vote to continue the plant, including its affiliated flocks, program in accordance with subpart E may participate in the Plan when the of part 147 of this chapter at a National producer or plant has demonstrated, to Plan Conference. the satisfaction of the Official State [71 FR 56328, Sept. 26, 2006, as amended at 74 Agency, that its facilities, personnel, FR 14716, Apr. 1, 2009]

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§ 146.4 General provisions for all par- chicken, and meat-type turkey slaugh- ticipating flocks and slaughter ter plants that are under continuous plants. inspection by the Food Safety and In- (a) Records that establish the iden- spection Service of the Department or tity of products handled shall be main- under State inspection that the Food tained in a manner satisfactory to the Safety and Inspection Service has rec- Official State Agency. ognized as equivalent to Federal in- (b) Material that is used to advertise spection may participate in the Plan. products shall be subject to inspection (b) To participate in the Plan, meat- by the Official State Agency at any type chicken, meat-type turkey, and time. commercial upland game bird and com- (c) Advertising must be in accordance mercial waterfowl slaughter plants with the Plan, and applicable rules and must follow the relevant special provi- regulations of the Official State Agen- sions in §§ 146.33(a), 146.43(a), and cy and the Federal Trade Commission. 146.53(a), respectively, for sample col- A participant advertising products as lection and flock monitoring, unless being of any official classification may they are exempted from the special include in their advertising reference to associated or franchised slaughter or provisions under §§ 146.32(b), 146.42(b), production facilities only when such fa- or 146.52(b), respectively. cilities produce products of the same [74 FR 14716, Apr. 1, 2009] classification. (d) Each participant shall be assigned § 146.7 Terminology and classification; a permanent approval number by the general. Service. This number, prefaced by the The official classification terms de- numerical code of the State, will be the fined in §§ 146.8 and 146.9 and the var- official approval number of the partici- ious designs illustrative of the official pant and may be used on each certifi- classifications reproduced in § 146.9 cate, invoice, shipping label, or other document used by the participant in may be used only by participants and the sale of the participant’s products. to describe products that have met all Each Official State Agency which re- of the specific requirements of such quires an approval number for out-of- classifications. State participants to ship into its State shall honor this number. § 146.8 Terminology and classification; slaughter plants. (Approved by the Office of Management and Budget under control number 0579–0007) Participating slaughter plants shall be designated as ‘‘U.S. H5/H7 Avian In- [71 FR 56328, Sept. 26, 2006, as amended at 75 fluenza Monitored.’’ All Official State FR 10658, Mar. 9, 2010] Agencies shall be notified by the Serv- § 146.5 Specific provisions for all par- ice of additions, withdrawals, and ticipating flocks. changes in classification. (a) Participating flocks, and all equipment used in connection with the § 146.9 Terminology and classification; flocks, products, and States. flocks, shall be separated from nonparticipating flocks in a manner ac- Participating flocks, products pro- ceptable to the Official State Agency. duced from them, and States that have (b) Poultry equipment, and poultry met the requirements of a classifica- houses and the land in the immediate tion in this part may be designated by vicinity thereof, shall be kept in sani- the corresponding illustrative design in tary condition as recommended in this section. § 147.21(c) of this subchapter. (a) U.S. H5/H7 Avian Influenza Mon- itored. (See §§ 146.23(a), 146.33(a), § 146.6 Specific provisions for participating slaughter plants. 146.43(a), and 146.53(a) and (b).) (a) Only commercial upland game bird, commercial waterfowl, meat-type

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(b) U.S. H5/H7 Avian Influenza Mon- itored State, Layers. (See § 146.24.) [71 FR 56328, Sept. 26, 2006, as amended at 74 FR 14716, Apr. 1, 2009; 76 FR 15796, Mar. 22, 2011]

§ 146.10 Supervision. (a) The Official State Agency may designate qualified persons as Author- ized Agents to do the sample collecting provided for in § 146.13 of this part. (b) The Official State Agency shall employ or authorize qualified persons as State Inspectors to perform the selecting and testing of participating flocks and to perform the official inspections necessary to verify compliance with the requirements of the Plan. (c) Authorities issued to Authorized Agents or State Inspectors under the (c) U.S. H5/H7 Avian Influenza Mon- provisions of this section shall be sub- itored State, Turkeys. (See § 146.44.) ject to cancellation by the Official State Agency on the grounds of incompetence or failure to comply with the provisions of the Plan or regulations of the Official State Agency. Such actions shall not be taken until thorough investigation has been made by the Offi- cial State Agency and the authorized person has been given notice of the proposed action and the basis thereof and an opportunity to present his or her views.

§ 146.11 Inspections. (a) Each participating slaughter plant shall be audited at least once annually or a sufficient number of times each year to satisfy the Official State

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Agency that the participating slaugh- ducted if a State Inspector determines ter plant is in compliance with the pro- that a breach of testing has occurred visions of this part. The yearly audit for the Plan programs for which the will consist of an evaluation of 2 flocks are certified. weeks’ worth of records, selected at (e) The official H5/H7 LPAI testing random, of the following data: records of all participating flocks and (1) The actual flock slaughter date slaughter plants shall be examined an- for each flock. This information must nually by a State Inspector. Official come from a verifiable source. H5/H7 LPAI testing records shall be Verifiable sources include electronic maintained for 3 years. record systems that have oversight from the Department’s Grain Inspec- (Approved by the Office of Management and Budget under control number 0579–0007) tors, Packers and Stockyards Adminis- tration or Food Safety and Inspection [71 FR 56328, Sept. 26, 2006, as amended at 74 Service (FSIS) documents such as FSIS FR 14716, Apr. 1, 2009; 75 FR 10658, Mar. 9, Form 9061–2. 2010] (2) Laboratory test results for each flock slaughtered with the sample col- § 146.12 Debarment from participation. lection date and test result. The test Participants in the Plan who, after must be NPIP-approved and performed investigation by the Official State in an authorized laboratory of the Agency or its representative, are noti- NPIP. fied in writing of their apparent non- (b) A flock will be considered to be compliance with the Plan provisions or not conforming to protocol if there are regulations of the Official State Agen- no test results available, if the flock cy shall be afforded a reasonable time, was not tested within 21 days before as specified by the Official State Agen- slaughter, or if the test results for the cy, within which to demonstrate or flocks were not returned before slaugh- achieve compliance. If compliance is ter. not demonstrated or achieved within (c) Two or more flocks that are found the specified time, the Official State to be not conforming to protocol in the Agency may debar the participant from yearly audit for a slaughter plant shall further participation in the Plan for be cause for a deficiency rating for that such period, or indefinitely, as the Offi- plant. However, if the root cause for cial State Agency may deem appro- the deficiency was identified, cor- priate. The debarred participant shall rected, and documented, the plant will be afforded notice of the bases for the be eligible for an immediate reevalua- debarment and opportunity to present tion of 2 additional weeks’ worth of his or her views with respect to the de- records, again selected at random. If no barment in accordance with procedures more than one missed flock is identi- adopted by the Official State Agency. fied in this reevaluation, the plant will The Official State Agency shall there- be considered in compliance and no fur- upon decide whether the debarment ther action will be required. Plants order shall continue in effect. Such de- found to be deficient must provide a cision shall be final unless the debarred written corrective action plan to the participant, within 30 days after the auditor within 2 weeks of receipt of the issuance of the debarment order, re- deficiency rating. A followup audit on quests the Administrator to determine the information in paragraphs (a)(1) the eligibility of the debarred partici- and (a)(2) of this section will occur pant for participation in the Plan. In within 90 days from the receipt of the such an event, the Administrator shall corrective action plan. Slaughter determine the matter de novo in ac- plants will retain their classification cordance with the rules of practice in 7 and may continue to use the Plan em- CFR part 50, which are hereby made blem in § 146.9(a) during this process. A applicable to proceedings before the failure on the followup audit may re- Administrator under this section. The sult in disbarment from participation definitions in 7 CFR 50.10 and the fol- according to the procedures in § 146.12. lowing definitions shall apply with re- (d) On-site inspections of any partici- spect to terms used in such rules of pating flocks and premises will be con- practice:

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(a) Administrator means the Adminis- (b) Avian influenza. The official tests trator, Animal and Plant Health In- for avian influenza are described in spection Service of the U.S. Depart- paragraphs (b)(1) and (b)(2) of this sec- ment of Agriculture, or any officer or tion: employee to whom authority has here- (1) Antibody detection tests—(i) En- tofore been delegated or to who author- zyme-linked immunosorbent assay ity may hereafter be delegated to act (ELISA). ELISA must be conducted in his or her stead. using test kits approved by the Depart- (b) [Reserved] ment and the Official State Agency and must be conducted in accordance with § 146.13 Testing. the recommendations of the producer or manufacturer. (a) Samples. Either egg or blood sam- (ii) The agar gel immunodiffusion ples may be used for testing. Samples (AGID) test. (A) The AGID test must be must be collected in accordance with conducted on all ELISA-positive sam- the following requirements: ples. (1) Egg samples. Egg samples must be (B) The AGID test must be conducted collected and prepared in accordance using reagents approved by the Depart- with the requirements in § 147.8 of this ment and the Official State Agency. subchapter. (C) Standard test procedures for the (2) Blood samples. Blood samples ob- AGID test for avian influenza are set tained in the slaughter plant should be forth in § 147.9 of this subchapter. The collected after the kill cut with birds test can be conducted on egg yolk or remaining on the kill line. Hold an blood samples. open 1.5 mL snap cap micro-centrifuge (D) Positive tests for the AGID must tube under the neck of the bird directly be further tested by Federal Reference after the kill cut and collect drips of Laboratories using appropriate tests blood until the tube is half full. Keep for confirmation. Final judgment may the blood tubes at room temperature be based upon further sampling and ap- for the clot to form, which should re- propriate tests for confirmation. quire a minimum of 4 hours and a max- (2) Agent detection tests. Agent detec- imum of 12 hours. Refrigerate the tube tion tests may be used to detect influ- after the clot has formed. Put tubes in enza A matrix gene or protein but not a container and label it with plant to determine hemagglutinin or name, date, shift (A.M. or Day, P.M. or neuraminidase subtypes. Samples for Night), and flock number. After the this testing should be collected from clot is formed, the clot should be re- naturally occurring flock mortality or moved by the Authorized Agent in clinically ill birds. order to ensure good-quality sera. Pre- (i) The real time reverse transcriptase/ pare a laboratory submission form and polymerase chain reaction (RRT–PCR) ship samples with submission forms to assay. (A) The RRT–PCR tests must be the laboratory in a polystyrene foam conducted using reagents approved by cooler with frozen ice packs. Submis- the Department and the Official State sion forms and the manner of submis- Agency. The RRT–PCR must be con- sion must be approved by the Official ducted using the National Veterinary State Agency and the authorized lab- Services Laboratories (NVSL) official oratory to ensure that there is suffi- protocol for RRT–PCR (AVPR01510) and cient information to identify the sam- must be conducted by personnel who ples and that the samples are received have passed an NVSL proficiency test. in an acceptable condition for further (B) Positive results from the RRT– tests to be reliably performed. Blood PCR must be further tested by Federal samples should be shipped routinely to Reference Laboratories using appro- the laboratory. Special arrangements priate tests for confirmation. Final should be developed for samples held judgment may be based upon further over the weekend to ensure that the sampling and appropriate tests for con- samples can be reliably tested. Blood firmation. samples for official tests shall be (ii) USDA-licensed type A influenza drawn by an Authorized Agent or State antigen capture immunoassay (ACIA). (A) Inspector. The USDA-licensed type A influenza

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ACIA must be conducted using test of smaller flocks, regarding the impor- kits approved by the Department and tance of prompt reporting of clinical the Official State Agency and must be symptoms consistent with avian influ- conducted in accordance with the rec- enza. ommendations of the producer or manufacturer. (Approved by the Office of Management and (B) Positive results from the ACIA Budget under control number 0579–0007) must be further tested by Federal Ref- [71 FR 56328, Sept. 26, 2006, as amended at 75 erence Laboratories using appropriate FR 10658, Mar. 9, 2010] tests for confirmation. Final judgment may be based upon further sampling Subpart B—Special Provisions for and appropriate tests for confirmation. Commercial Table-Egg Layer (3) The official determination of a flock as positive for the H5 or H7 Flocks subtypes avian influenza may be made § 146.21 Definitions. only by NVSL. Table-egg layer. A domesticated (Approved by the Office of Management and chicken grown for the primary purpose Budget under control number 0579–0007) of producing eggs for human consump- [71 FR 56328, Sept. 26, 2006, as amended at 74 tion. FR 14716, Apr. 1, 2009; 75 FR 10658, Mar. 9, Table-egg layer pullet. A sexually im- 2010] mature domesticated chicken grown § 146.14 Diagnostic surveillance pro- for the primary purpose of producing gram for H5/H7 low pathogenic eggs for human consumption. avian influenza. [71 FR 56328, Sept. 26, 2006, as amended at 76 (a) The Official State Agency must FR 15796, Mar. 22, 2011] develop a diagnostic surveillance program for H5/H7 low pathogenic avian § 146.22 Participation. influenza for all poultry in the State. (a) Participating commercial table- The exact provisions of the program egg layer flocks shall comply with the are at the discretion of the States. The applicable general provisions of sub- Service will use the standards in para- part A of this part and the special pro- graph (b) of this section in assessing in- visions of subpart B of this part. dividual State plans for adequacy, including the specific provisions that the (b) Commercial table-egg laying State developed. The standards should premises with fewer than 75,000 birds be used by States in developing those are exempt from the special provisions plans. of subpart B of this part. (b) Avian influenza must be a disease reportable to the responsible State au- § 146.23 Terminology and classification; flocks and products. thority (State veterinarian, etc.) by all licensed veterinarians. To accomplish Participating flocks which have met this, all laboratories (private, State, the respective requirements specified and university laboratories) that per- in this section may be designated by form diagnostic procedures on poultry the following terms and the cor- must examine all submitted cases of responding designs illustrated in § 146.9 unexplained respiratory disease, egg of this part: production drops, and mortality for (a) U.S. H5/H7 Avian Influenza Mon- avian influenza by both an approved se- itored. This program is intended to be rological test and an approved antigen the basis from which the table-egg detection test. Memoranda of under- layer industry may conduct a program standing or other means must be used to monitor for the H5/H7 subtypes of to establish testing and reporting cri- avian influenza. It is intended to deter- teria (including criteria that provide mine the presence of the H5/H7 for reporting H5 and H7 low pathogenic subtypes of avian influenza in table-egg avian influenza directly to the Service) layers and table-egg layer pullets and approved testing methods. In addi- through routine surveillance of each tion, States should conduct outreach participating commercial table-egg to poultry producers, especially owners layer and table-egg layer pullet flock.

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A flock will qualify for this classifica- provisions of this subpart B under tion when the Official State Agency de- § 146.22 are classified as U.S. H5/H7 termines that it has met one of the fol- Avian Influenza Monitored under lowing requirements: § 146.23(a) of this part; (1) Table-egg layer pullet flocks. (i) It is (ii) All egg-type chicken breeding a commercial table-egg layer pullet flocks in production within the State flock in which a minimum of 11 birds are classified as U.S. Avian Influenza have been tested negative to the H5/H7 Clean under § 145.23(h) of this sub- subtypes of avian influenza as provided chapter; in § 146.13(b) within 30 days prior to (iii) All persons performing poultry movement; or disease diagnostic services within the (ii) It is a commercial table-egg layer State are required to report to the Offi- pullet flock that has an ongoing active cial State Agency, within 24 hours, the and diagnostic surveillance program source of all table-egg layer and table- for the H5/H7 subtypes of avian influ- egg layer pullet specimens that were enza in which the number of birds test- deemed positive on an official test for ed is equivalent to the number required avian influenza, as designated in in paragraph (a)(1)(i) of this section § 146.13(a) of this chapter; and that is approved by the Official (iv) All table-egg layer and table-egg State Agency and the Service. layer pullet specimens that were (2) Table-egg layer flocks. (i) It is a deemed positive on an official test for commercial table-egg layer flock in avian influenza, as designated in which a minimum of 11 birds have been § 146.13(a) of this chapter, are sent to an tested negative to the H5/H7 subtypes authorized laboratory for subtyping; of avian influenza as provided in and § 146.13(b) within 30 days prior to dis- (v) All table-egg layer and table-egg posal; layer pullet flocks within the State (ii) It is a commercial table-egg layer that are found to be infected with the flock in which a minimum of 11 birds H5/H7 subtypes of avian influenza are have been tested negative for the H5/H7 quarantined, in accordance with an ini- subtypes of avian influenza as provided tial State response and containment in § 146.13(b) within a 12-month period; plan as described in part 56 of this or chapter and under the supervision of (iii) It is a commercial table-egg the Official State Agency. layer flock that has an ongoing active and diagnostic surveillance program (2) If there is a discontinuation of for the H5/H7 subtypes of avian influ- any of the conditions described in para- enza in which the number of birds test- graph (a)(1) of this section, or if reed is equivalent to the number required peated outbreaks of the H5/H7 subtypes in paragraph (a)(2)(i) or paragraph of avian influenza occur in commercial (a)(2)(ii) of this section and that is ap- table-egg layer flocks as described in proved by the Official State Agency paragraph (a)(1)(i) of this section, or if and the Service. an infection spreads from the origi- (b) [Reserved] nating premises, the Service shall have grounds to revoke its determination [71 FR 56328, Sept. 26, 2006, as amended at 76 that the State is entitled to this classi- FR 15796, Mar. 22, 2011] fication. Such action shall not be taken until a thorough investigation § 146.24 Terminology and classification; States. has been made by the Service and the Official State Agency has been given (a) U.S. H5/H7 Avian Influenza Mon- an opportunity for a hearing in accord- itored State, Layers. (1) A State will be ance with rules of practice adopted by declared a U.S. H5/H7 Avian Influenza the Administrator. Monitored State, Layers when it has (b) [Reserved] been determined by the Service that: (i) All commercial table-egg layer (Approved by the Office of Management and flocks and all commercial table-egg Budget under control number 0579–0007) layer pullet flocks that supply those [71 FR 56328, Sept. 26, 2006, as amended at 75 flocks in production within the State FR 10658, Mar. 9, 2010; 76 FR 15797, Mar. 22, that are not exempt from the special 2011]

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Subpart C—Special Provisions for bodies to the H5/H7 subtypes of avian Meat-Type Chicken Slaughter influenza, as provided in § 146.13(b), at Plants slaughter; Provided, that with the approval of the Official State Agency, § 146.31 Definitions. fewer than 11 birds per shift may be Meat-type chicken. A domesticated tested on any given shift if the total chicken grown for the primary purpose number of birds tested during the oper- of producing meat, including but not ating month is equivalent to testing 11 limited to broilers, roasters, fryers, birds per shift; or and cornish. (2) It is a meat-type chicken slaugh- Meat-type chicken slaughter plant. A ter plant which accepts only meat-type meat-type chicken slaughter plant that chickens from flocks where a minimum is federally inspected or under State of 11 birds have been tested negative inspection that the Food Safety Inspec- for antibodies to the H5/H7 subtypes of tion Service has recognized as equiva- avian influenza, as provided in lent to federal inspection. § 146.13(b), no more than 21 days prior Shift. The working period of a group to slaughter; or of employees who are on duty at the (3) It is a meat-type chicken slaugh- same time. ter plant that has an ongoing active § 146.32 Participation. and diagnostic surveillance program (a) Participating meat-type chicken for the H5/H7 subtypes of avian influ- slaughter plants shall comply with ap- enza in which the number of birds test- plicable general provisions of subpart A ed is equivalent to the number required of this part and the special provisions in paragraph (a)(1) or (a)(2) and that is of this subpart C. approved by the Official State Agency (b) Meat-type chicken slaughter and the Service. plants that slaughter fewer than 200,000 (b) [Reserved] meat-type chickens in an operating week are exempt from the special pro- [71 FR 56328, Sept. 26, 2006, as amended at 76 FR 15797, Mar. 22, 2011] visions of this subpart C. § 146.33 Terminology and classifica- Subpart D—Special Provisions for tion; meat-type chicken slaughter Meat-Type Turkey Slaughter Plants plants. Participating meat-type chicken § 146.41 Definitions. slaughter plants that have met the re- Meat-type turkey. A domesticated tur- spective requirements specified in this key grown for the primary purpose of section may be designated by the fol- producing meat. lowing terms and the corresponding designs illustrated in § 146.9 of this part: Meat-type turkey slaughter plant. A (a) U.S. H5/H7 Avian Influenza Mon- meat-type turkey slaughter plant that itored. This program is intended to be is federally inspected or under State the basis from which the meat-type inspection that the Food Safety Inspec- chicken industry may conduct a pro- tion Service has recognized as equiva- gram to monitor for the H5/H7 subtypes lent to federal inspection. of avian influenza. It is intended to determine the presence of the H5/H7 § 146.42 Participation. subtypes of avian influenza in meat- (a) Participating meat-type turkey type chickens through routine surveil- slaughter plants shall comply with ap- lance of each participating meat-type plicable general provisions of subpart A chicken slaughter plant. A meat-type of this part and the special provisions chicken slaughter plant will qualify for of this subpart D. this classification when the Official (b) Meat-type turkey slaughter State Agency determines that it has plants that slaughter fewer than 2 mil- met one of the following requirements: lion meat-type turkeys in a 12-month (1) It is a meat-type chicken slaughter plant where a minimum of 11 birds period are exempt from the special proper shift are tested negative for anti- visions of this subpart D.

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§ 146.43 Terminology and classifica- § 146.44 Terminology and classification; meat-type turkey slaughter tion; States. plants. (a) U.S. H5/H7 Avian Influenza Mon- Participating meat-type turkey itored State, Turkeys. (1) A State will be slaughter plants which have met the declared a U.S. H5/H7 Avian Influenza respective requirements specified in Monitored State, Turkeys when it has this section may be designated by the been determined by the Service that: following terms and the corresponding (i) All meat-type turkey slaughter designs illustrated in § 146.9 of this plants within the State that are not part: exempt from the special provisions of (a) U.S. H5/H7 Avian Influenza Mon- this subpart D under § 146.42 are classi- itored. This program is intended to be fied as U.S. H5/H7 Avian Influenza Mon- the basis from which the meat-type itored under § 146.43(a) of this part; turkey industry may conduct a pro- (ii) All turkey breeding flocks in program to monitor for the H5/H7 subtypes duction within the State are classified of avian influenza. It is intended to de- as U.S. H5/H7 Avian Influenza Clean termine the presence of avian influenza under § 145.43(g) of this subchapter; in meat-type turkeys through routine (iii) All persons performing poultry surveillance of each participating disease diagnostic services within the meat-type turkey slaughter plant. A State are required to report to the Offi- participating meat-type turkey slaugh- cial State Agency, within 24 hours, the ter plant will qualify for this classi- source of all meat-type turkey specification when the Official State Agen- mens that were deemed positive on an cy determines that it has met one of official test for avian influenza, as des- the following requirements: ignated in § 146.13(a) of this chapter; (1) It is a meat-type turkey slaughter (iv) All meat-type turkey specimens plant that accepts only meat-type tur- that were deemed positive on an offi- keys from flocks where a minimum of cial test for avian influenza, as des- 6 birds per flock has tested negative for ignated in § 146.13(a) of this chapter, are antibodies to type A avian influenza, as sent to an authorized laboratory for provided in § 146.13(b), with an approved subtyping; and test no more than 21 days prior to (v) All meat-type turkey flocks with- slaughter. Positive samples shall be in the State that are found to be in- further tested by an authorized labora- fected with the H5/H7 subtypes of avian tory using the hemagglutination inhi- influenza are quarantined, in accord- bition test to detect antibodies to the ance with an initial State response and hemagglutinin subtypes H5 and H7. It containment plan as described in part is recommended that samples be col- 56 of this chapter, and under the super- lected from flocks over 10 weeks of age vision of the Official State Agency. with respiratory signs such as (2) If there is a discontinuation of coughing, sneezing, snicking, sinusitis, any of the conditions described in para- or rales; depression; or decreases in graph (a)(1) of this section, or if re- food or water intake. peated outbreaks of the H5/H7 subtypes (2) It is a meat-type turkey slaughter of avian influenza occur in meat-type plant that has an ongoing active and turkey flocks as described in paragraph diagnostic surveillance program for the (a)(1)(i) of this section, or if an infec- H5/H7 subtypes of avian influenza in tion spreads from the originating which the number of birds tested is premises, the Service shall have equivalent to the number required in grounds to revoke its determination paragraph (a)(1) and that is approved that the State is entitled to this classi- by the Official State Agency and the fication. Such action shall not be Service. taken until a thorough investigation (b) [Reserved] has been made by the Service and the [71 FR 56328, Sept. 26, 2006, as amended at 74 Official State Agency has been given FR 14717, Apr. 1, 2009; 76 FR 15797, Mar. 22, 2011]

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an opportunity for a hearing in accord- § 146.52 Participation. ance with rules of practice adopted by (a) Participating commercial upland the Administrator. game bird slaughter plants, commer- (Approved by the Office of Management and cial waterfowl slaughter plants, raised- Budget under control number 0579–0007) for-release upland game bird premises, and raised-for-release waterfowl prem- [71 FR 56328, Sept. 26, 2006, as amended at 75 ises shall comply with the applicable FR 10658, Mar. 9, 2010] general provisions of Subpart A of this part and the special provisions of this Subpart E—Special Provisions for subpart E. Commercial Upland Game (b) Commercial waterfowl and com- Birds, Commercial Waterfowl, mercial upland game bird slaughter Raised-for-Release Upland plants that slaughter fewer than 50,000 Game Birds, and Raised-for- birds annually are exempt from the Release Waterfowl special provisions of this subpart E. (c) Raised-for-release upland game bird premises and raised-for-release SOURCE: 74 FR 14717, Apr. 1, 2009, unless waterfowl premises that raise fewer otherwise noted. than 25,000 birds annually are exempt from the special provisions of this sub- § 146.51 Definitions. part E. Commercial upland game bird slaughter plant. A commercial upland game bird § 146.53 Terminology and classifica- slaughter plant that is federally in- tion; slaughter plants and premises. spected or under State inspection that Participating flocks which have met the U.S. Department of Agriculture’s the respective requirements specified Food Safety and Inspection Service has in this section may be designated by recognized as equivalent to Federal in- the following terms and the cor- spection. responding designs illustrated in § 146.9 Commercial upland game birds. Upland of this part: game bird pheasants, quail, or par- (a) U.S. H5/H7 Avian Influenza Mon- tridges grown under confinement for itored. This program is intended to be the primary purpose of producing meat the basis from which the commercial for human consumption. waterfowl and commercial upland game bird industry may conduct a pro- Commercial waterfowl. Domesticated gram to monitor for the H5/H7 subtypes ducks or geese grown under confine- of avian influenza. It is intended to de- ment for the primary purpose of pro- termine the presence of the H5/H7 ducing meat for human consumption. subtypes of avian influenza in commer- Commercial waterfowl slaughter plant. cial waterfowl and commercial upland A commercial waterfowl slaughter game birds through routine surveil- plant that is federally inspected or lance of each participating slaughter under State inspection that the U.S. plant. A slaughter plant will qualify Department of Agriculture’s Food for this classification when the Official Safety and Inspection Service has rec- State Agency determines that it has ognized as equivalent to Federal in- met one of the following requirements: spection. (1) It is a commercial upland game Raised-for-release upland game birds. bird slaughter plant or commercial wa- Pheasants, quail, and partridge that terfowl slaughter plant where a min- are raised under confinement for re- imum of 11 birds per shift are tested lease in game preserves and are not negative for the H5/H7 subtypes of breeding stock. avian influenza, as provided in Raised-for-release waterfowl. Water- § 146.13(b), at slaughter; fowl that are raised under confinement (2) It is a commercial upland game for release in game preserves and are bird slaughter plant or commercial wa- not breeding stock. terfowl slaughter plant that only ac- Shift. The working period of a group cepts commercial upland game birds or of employees who are on duty at the commercial waterfowl from flocks same time. where a minimum of 11 birds per flock

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have been tested negative for the H5/H7 egg-type breeding flocks with salmonella subtypes of avian influenza, as pro- enteritidis positive environments. vided in § 146.13(b), no more than 21 147.11 Laboratory procedure recommended days prior to slaughter; or for the bacteriological examination of (3) It is a commercial upland game salmonella. 147.12 Procedures for collection, isolation, bird slaughter plant or commercial wa- and identification of Salmonella from en- terfowl slaughter plant that has an on- vironmental samples, cloacal swabs, going active and passive surveillance chick box papers, and meconium sam- program for H5/H7 subtypes of avian in- ples. fluenza that is approved by the Official 147.13 Procedure for bacteriological cul- State Agency and the Service. turing of eggshells for colon bacilli orga- (b) U.S. H5/H7 Avian Influenza Mon- nisms. itored. This program is intended to be 147.14 Procedures to determine status and the basis from which the raised-for-re- effectiveness of sanitation monitored lease upland game bird and raised-for- program. 147.15 Laboratory procedure recommended release waterfowl industries may con- for the bacteriological examination of duct a program to monitor for the H5/ mycoplasma reactors. H7 subtypes of avian influenza. It is in- 147.16 Procedure for the evaluation of myco- tended to determine the presence of the plasma reactors by in vivo bio-assay (en- H5/H7 subtypes of avian influenza richment). through routine surveillance of each 147.17 Laboratory procedure recommended participating premises. A premises will for the bacteriological examination of qualify for the classification when the cull chicks and poults for salmonella. Official State Agency determines that a representative sample of 30 birds Subpart C—Sanitation Procedures from the participating premises has 147.21 Flock sanitation. been tested with negative results for 147.22 Hatching egg sanitation. the H5/H7 subtypes of avian influenza, 147.23 Hatchery sanitation. as provided in § 146.13(b), every 90 days. 147.24 Cleaning and disinfecting. 147.25 Fumigation. [74 FR 14717, Apr. 1, 2009, as amended at 76 147.26 Procedures for establishing isolation FR 15797, Mar. 22, 2011] and maintaining sanitation and good management practices for the control of PART 147—AUXILIARY PROVISIONS Salmonella and Mycoplasma infections. ON NATIONAL POULTRY IM- 147.27 Procedures recommended to prevent the spread of disease by artificial insemi- PROVEMENT PLAN nation of turkeys.

Subpart A—Blood Testing Procedures Subpart D—Molecular Examination Sec. Procedures 147.1 The standard tube agglutination test. 147.30 Laboratory procedure recommended 147.2 The rapid serum test. for the polymerase chain reaction (PCR) 147.3 The stained-antigen, rapid, whole- test for Mycoplasma gallisepticum and blood test. 147.4 [Reserved] M. synoviae. 147.5 The microagglutination test for pul- 147.31 Laboratory procedures recommended lorum-typhoid. for the real-time polymerase chain reac- 147.6 Procedure for determining the status tion test for Mycoplasma gallisepticum of flocks reacting to tests for Myco- (MGLP ReTi). plasma gallisepticum, Mycoplasma synoviae, and Mycoplasma meleagridis. Subpart E—Procedure for Changing 147.7 Standard test procedures for myco- National Poultry Improvement Plan plasma. 147.8 Procedures for preparing egg yolk 147.41 Definitions. samples for diagnostic tests. 147.42 General. 147.9 Standard test procedures for avian in- 147.43 General Conference Committee. fluenza. 147.44 Submitting, compiling, and distributing proposed changes. Subpart B—Bacteriological Examination 147.45 Official delegates. Procedure 147.46 Committee consideration of proposed changes. 147.10 Laboratory procedure recommended 147.47 Conference consideration of proposed for the bacteriological examination of changes.

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147.48 Approval of conference recommenda- (3) The blood samples must reach the tions by the Department. laboratory in a fresh and unhemolyzed condition. Hemolyzed samples should Subpart F—Authorized Laboratories and be rejected. It is imperative, therefore, Approved Tests to cool the tubes immediately after 147.51 Authorized laboratory minimum re- slanting and clotting, and unless they quirements. reach the laboratory within a few 147.52 Approved tests. hours, to pack them with ice in special containers, or use some other cooling AUTHORITY: 7 U.S.C. 8301–8317; 7 CFR 2.22, 2.80, and 371.4. system which will insure their preservation during transportation. In severe SOURCE: 36 FR 23121, Dec. 3, 1971, unless cold seasons, extreme precautions must otherwise noted. Redesignated at 44 FR 61586, be exercised to prevent freezing and Oct. 26, 1979. consequent laking. The samples must be placed in cold (5 °to 10 °C.) storage, Subpart A—Blood Testing immediately upon arrival at the lab- Procedures oratory. (b) The antigen shall consist of rep- § 147.1 The standard tube agglutina- 1 resentative strains of S. pullorum tion test. which are of known antigenic composi- (a) The blood samples should be col- tion, high agglutinability, but are not lected and delivered as follows: sensitive to negative and nonspecific (1) The blood samples should be sera. The stock cultures may be main- taken by properly qualified and author- tained satisfactorily by transferring to ized persons only, and in containers new sloped agar at least once a month provided by the laboratory. The con- and keeping at 18 °to 25 °C. (average tainers should be stout-walled test room temperature) in a dark closet or tubes, preferably 3⁄8 by 3 inches, with- chest, following incubation for from 24 out lip, or small well-selected medicine to 36 hours at 37 °C. The antigenic com- vials, which have been thoroughly position and purity of the stock cul- cleaned and dried in a hot-air drying tures should be checked consistently. oven. If stoppers are used, they should (c) A medium which has been used be thoroughly cleaned and dried. satisfactorily has the following com- (2) Sufficient blood should be pro- position: cured by making a small incision in Water ...... 1,000 cc. the large median wing vein with a Difco beef extract ...... 4 gm. (0.4 percent). small sharp lancet and allowing the Difco Bacto-peptone ...... 10 gm. (1.0 percent). blood to run into the tube, or by the Difco dry-granular agar...... 20 gm. (2.0 percent). Reaction—pH 6.8 to 7.2. use of a small syringe (with 20 or 21 gage needle) which is properly cleansed (d) Large 1–inch test tubes, Kolle between bleedings with physiological flasks, or Blake bottles should be saline solution. To facilitate the sepa- streaked liberally over the entire agar ration of the serum, the tubes should surface with inoculum from 48–hour be placed in a slanted position until slant agar cultures prepared from the the blood has solidified. After the blood stock cultures of the selected strains. has completely clotted, they should be The antigen-growing tubes or bottles packed and shipped by mail (special de- should be incubated 48 hours at 37 °C., livery), rapid express, or by messenger, and the surface growth washed off with to the laboratory. All labeling must be sufficient phenolized (0.5 percent) sa- clear and permanent, and may be done line (0.85 percent) solution to make a with a suitable pencil on etched por- heavy suspension. The suspension tions of the tube, or by means of fast- should be filtered free of clumps gum labels. through a thin layer of absorbent cotton in a Buchner funnel with the aid of suction. The antigens of the separate 1 The procedure described is a modification of the method reported in the Proceedings of strains should be combined in equal the U.S. Live Stock Sanitary Association, volume-density and stored in the re- November 30 to December 2, 1932, pp. 487 to frigerator (5 °to 10 °C.) in tightly 491. stoppered bottles.

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(e) Thiosulfate-Glycerin (TG) me- land nephelometer scale. The hydro- dium may be used as an alternate me- gen-ion concentration of the diluted dium for the preparation of tube agglu- antigen should be corrected to pH 8.2 to tination antigen. The TG medium, for- 8.5 by the addition of dilute sodium hy- merly used for the preparation of droxide. New diluted antigen should be stained, whole-blood antigen, is de- prepared each day and kept cold. The scribed in more detail in the article by diluted antigen may be employed in 2 A. D. MacDonald, Recent Develop- cc. quantities in 4 by 1⁄2–inch test ments in Pullorum Antigen for the tubes, or 1 cc. quantities in smaller Rapid, Whole-Blood Test, Report of the tubes, in which the final serum-antigen Conference of the National Poultry Im- mixtures are made and incubated. The provement Plan, pages 122–127, 1941. distribution of the antigen in the tubes This medium provides a tube antigen of may be accomplished by the use of long excellent specificity and greatly in- burettes, or special filling devices creases the yield of antigen from a made for the purpose. given amount of medium. The TG me- (g) The maximum serum dilution em- dium has the following composition: ployed must not exceed 1:50 for chick- Beef infusion ...... 1,000 cc. ens, nor 1:25 for turkeys. The available Difco Bacto-peptone ...... 20 gm. (2.0 percent). data indicate that 1:25 dilution is the Sodium thiosulfate ...... 5 gm. (0.5 percent). most efficient. In all official reports on Ammonium chloride ...... 5 gm. (0.5 percent). Glycerin, U.S.P. (95 percent) 20 cc. (2.0 percent). the blood test, the serum dilutions Difco dry-granular agar...... 30 gm. (3.0 percent). shall be indicated. The sera should be Reaction—pH 6.8 to 7.2. introduced into the agglutination Large 1–inch test tubes, Kolle flasks, tubes in the desired amounts with well- Blake bottles, or Erlenmeyer flasks cleaned serological pipettes or special should be seeded over the entire agar serum-delivery devices which do not surface with inoculum from 24–hour permit the mixing of different sera. beef infusion broth cultures prepared The antigen and serum should be well from the stock cultures of the selected mixed before incubation. The serum strains. The antigen-growing tubes or and antigen mixture must be incubated bottles should be incubated 96 hours at for at least 20 hours at 37 °C. 37 °C., and the surface growth washed (h) The results shall be recorded as: off with sufficient phenolized (0.5 per- N, or ¥ (negative) when the serum-antigen cent) saline (0.85 percent) solution to mixture remains uniformly turbid. make a heavy suspension. The suspen- P, or + (positive) when there is a distinct sion should be filtered free of clumps clumping of the antigen, and the liquid be- through a thin layer of absorbent cot- tween the agglutinated particles is clear. ton in a Buchner funnel with the aid of S, or ? (suspicious) when the agglutination is only partial or incomplete. suction. The antigen then should be M, or missing, when samples listed on the centrifuged. The mass of bacteria original record sheet are missing. should be removed from the centrifuge H, or hemolyzed, when blood samples are tubes or bowl and resuspended in saline hemolyzed and cannot be tested. (0.85 percent) solution containing 0.5 B, or broken, when sample tubes are broken percent phenol. After the bacterial and no serum can be obtained. mass has been uniformly suspended in (Some allowance must always be made for the diluent, it should be again passed the difference in sensitiveness of different through a cotton pad in a Buchner fun- antigens and different set-ups, and therefore, a certain amount of independent, intelligent nel without the aid of suction. The judgment must be exercised at all times. antigens of the separate strains should Also, the histories of the flocks require con- be combined in equal volume-density sideration. In flocks where individuals show and stored in the refrigerator (5 °to 10 a suspicious agglutination, it is desirable to °C.) in tightly stoppered bottles. examine representative birds bacterio- (f) The diluted antigen to be used in logically to determine the presence or ab- the routine testing should be prepared sence of S. pullorum.) from the stock antigen by dilution of (Approved by the Office of Management and the latter with physiological (0.85 per- Budget under control number 0579–0007) cent) saline solution containing 0.25 [36 FR 23121, Dec. 3, 1971. Redesignated at 44 percent of phenol to a turbidity cor- FR 61586, Oct. 26, 1979, as amended at 59 FR responding to 0.75–1.00 on the McFar- 12799, Mar. 18, 1994]

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§ 147.2 The rapid serum test. 2 ing should be made at the end of 2 or 3 minutes. Heating the plate at approxi- (a) The procedure for the collection ° and delivery of blood samples in the mately 37 C. will hasten agglutination. rapid serum test is the same as that de- Before reading, the plate should be ro- scribed in § 147.1(a). tated several times. (b) The selection and maintenance of (h) The results shall be recorded as suitable strains of S. pullorum and the described in § 147.1(h). composition of a satisfactory medium (Approved by the Office of Management and are described in § 147.1 (b) and (c). Budget under control number 0579–0007) (c) Large 1–inch test tubes, Kolle [36 FR 23121, Dec. 3, 1971. Redesignated at 44 flasks, or Blake bottles are streaked FR 61586, Oct. 26, 1979, as amended at 59 FR liberally from 48–hour slant-agar cul- 12799, Mar. 18, 1994] tures prepared from stock cultures of the selected strains. § 147.3 The stained-antigen, rapid, (d) The antigen-growing tubes or bot- whole-blood test. 3 tles should be incubated 48 hours at 37 (a) The description of the preparation °C., and the surface growth washed off of antigen is not herein included be- with a very slight amount of 12 percent cause the antigen is a proprietary prod- solution of sodium chloride containing uct produced only under license from 0.25 to 0.5 percent phenol, filtered the Secretary of Agriculture. through lightly packed sterile absorb- (b) A loop for measuring the correct ent cotton placed in the apex of a ster- quantity of blood can usually be ob- ile funnel. tained from the manufacturer of the (e) The washings should be adjusted antigen. A satisfactory loop may be (using 12 percent sodium chloride con- made from a piece of No. 20 gage taining 0.25 to 0.5 percent phenol) so nichrome wire, 21⁄2 inches long, at the that the turbidity is 50 times greater end of which is fashioned a loop three- than tube 0.75 of McFarland’s nephe- sixteenths of an inch in diameter. Such lometer, or to a reading of 7 mm. by a loop, when filled with blood so that the Gates nephelometer. the blood appears to bulge, delivers 0.02 (f) The individual strain antigens cc. A medicine dropper whose tip is ad- should be tested with negative sera for justed to deliver 0.05 cc. is used to their insensitivity and with positive measure the antigen. A glass plate sera for high agglutinability in com- about 15 inches square, providing space parison with known satisfactory anti- for 48 tests, has proved satisfactory for gen. The antigens of the separate this work. The use of such a plate en- strains should be combined in equal ables the tester to have a number of volume-density and stored in the re- successive test mixtures under observa- frigerator (5 ° to 10 °C.) in tightly tion without holding up the work to stoppered bottles. wait for results before proceeding to (g) The tests should be conducted on the next bird. a suitable, smooth plate. The serum- (c) A drop of antigen should be placed antigen dilution should be made so on the testing plate. A loopful of blood that the dilution will not exceed 1:50 should be taken up from the wing vein. when compared to the standard tube When submerged in the blood and then agglutination test. When testing tur- carefully withdrawn, the loop becomes key blood samples, it is desirable to properly filled. On looking down edge- use a serum-antigen dilution equiva- wise at the filled loop, one observes lent to the 1:25 in the tube method. The that the blood appears to bulge. The serum should be added to the antigen loopful of blood then should be stirred and mixed thoroughly by use of the tip into the drop of antigen, and the mix- of the serum pipette. Most strong posi- ture spread to a diameter of about 1 tive reactions will be plainly evident inch. The loop then should be rinsed in within 15 to 20 seconds. The final read- clean water and dried by touching it to

2 The procedure described is a modification 3 The procedure described is a modification of the method reported by Runnels, Coon, of the method reported by Schaffer, Mac- Farley, and Thorpe, Amer. Vet. Med. Assoc. Donald, Hall, and Bunyea, Jour. Amer. Vet. Jour. 70 (N.S. 23): 660–662 (1927). Med. Assoc. 79 (N. S. 32): 236–240 (1931).

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a piece of clean blotting paper, if nec- that has proven advantageous is to essary. The test plate should be rocked transfer the serum samples from the from side to side a few times to mix the blood clot to a microplate as described antigen and blood thoroughly, and to in ‘‘Applied Microbiology,’’ volume 24, facilitate agglutination. The antigen No. 4, October 1972, pages 671–672. The should be used according to the direc- dilutions are then performed according tions of the producer. to paragraphs (d) or (e) of this section. (d) Various degrees of reaction are (b) Stained microtest antigen for pul- observed in this as in other agglutina- lorum-typhoid is supplied as con- tion tests. The greater the aggluti- centrated stock suspension and must nating ability of the blood, the more be approved by the Department. 4 Di- rapid the clumping and the larger the rections for diluting will be provided clumps. A positive reaction consists of with the antigen. The stock as well as a definite clumping of the antigen sur- the diluted antigen prepared each day rounded by clear spaces. Such reaction should be kept sealed in the dark at 5 is easily distinguished against a white ° to 10 °C. when not in use. background. A somewhat weaker reaction consists of small but still clearly (c) Available data indicate that a 1:40 visible clumps of antigen surrounded dilution for the microagglutination by spaces only partially clear. Between test is most efficient for the detection this point and a negative or homo- of pullorum-typhoid agglutinins in geneous smear, there sometimes occurs both chickens and turkeys. In all offi- a very fine granulation barely visible cial reports on the blood test, the to the naked eye; this should be dis- serum dilutions shall be indicated. regarded in making a diagnosis. The (d) The recommended procedure for very fine marginal clumping which the 1:40 dilution in the microagglutina- may occur just before drying up is also tion test is as follows: regarded as negative. In a nonreactor, (1) Add 100 microliters (0.10 cc.) of the smear remains homogeneous. (Al- 0.85 percent physiological saline to lowance should be made for differences each well of the microplate. in the sensitiveness of different anti- (2) Using a microdiluter or a gens and different set-ups, and there- multimicrodiluter handle fitted with fore, a certain amount of independent, twelve 10 microliter microdiluters, intelligent judgment must be exercised transfer 5 microliters (0.005 cc.) of the at all times. Also, the histories of the serum sample from the collected speci- flocks require consideration. In flocks men to the corresponding well of the where individuals show a suspicious ag- microplate. This is accomplished by glutination, it is desirable to examine touching the surface of the serum sam- representative birds bacteriologically ple with the microdiluter and then to determine the presence or absence of transferring and mixing with the dil- S. pullorum.) uent in the microplate well. The micro- (Approved by the Office of Management and diluter is removed, blotted, touched to Budget under control number 0579–0007) the surface of the distilled water wash, [36 FR 23121, Dec. 3, 1971. Redesignated at 44 and again blotted. Other acceptable FR 61586, Oct. 26, 1979, as amended at 59 FR methods of serum delivery are de- 12799, Mar. 18, 1994] scribed in ‘‘Applied Microbiology,’’ volume 21, No. 3, March 1971, pages 394–399. § 147.4 [Reserved] (3) Dilute the microtest antigens with 0.50 percent phenolized saline and § 147.5 The microagglutination test for pullorum-typhoid. add 100 microliters (0.1 cc.) to each microplate well. Routinely, the microagglutination test is applied as a single-dilution test 4 and only a single 18–24 hour reading is Information as to criteria and procedures for approval of concentrated stock suspen- made. sion of stained microtest antigens may be (a) The procedure for the collection obtained from the National Poultry Improve- and delivery of blood samples in the ment Plan, Veterinary Services, APHIS, microagglutination test is the same as USDA, 1506 Klondike Road, Suite 300, Con- that described in § 147.1(a). A method yers, GA 30094.

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(4) Seal each plate with a plastic more positive than negative [±] or vice sealer or place unsealed in a tight incu- versa [û] and can be so noted if desired. bation box as described in ‘‘Applied Microbiology,’’ volume 23, No. 5, May (Approved by the Office of Management and Budget under control number 0579–0007) 1972, pages 931–937. Incubate at 37 °C. for 18–24 hours. [41 FR 48726, Nov. 5, 1976. Redesignated at 44 (5) Read the test results as described FR 61586, Oct. 26, 1979, and amended at 57 FR in paragraph (f) of this section. 57342, Dec. 4, 1992; 59 FR 12799, Mar. 18, 1994; (e) The recommended procedure for a 59 FR 67617, Dec. 30, 1994; 61 FR 11521, Mar. 21, microagglutination test titration is as 1996; 63 FR 3, Jan. 2, 1998; 67 FR 8469, Feb. 25, 2002; 76 FR 15797, Mar. 22, 2011] follows: (1) Add 50 microliters (0.05cc.) of 0.85 § 147.6 Procedure for determining the percent physiological saline to each status of flocks reacting to tests for well of the microplate. Mycoplasma gallisepticum, Myco- (2) To the wells representative of the plasma synoviae, and Mycoplasma lowest dilution in the titration, add an meleagridis. additional 50 microliters (0.05 cc.) of Procedures for isolation and identi- 0.85 percent physiological saline mak- fication of Mycoplasma may be found ing a total of 100 microliters in these in Isolation and Identification of Avian wells. Pathogens, published by the American (3) Transfer each serum sample as de- Association of Avian Pathologists; scribed in § 147.5(d)(2) of this section to Kleven, S.H., F.T.W. Jordan, and J.M. the first well containing 100 microliters Bradbury, Avian Mycoplasmosis (0.10cc.) in the titration, which rep- (Mycoplasma gallisepticum), Manual of resents the lowest dilution. Diagnostic Tests and Vaccines for Ter- (4) Make twofold serial dilutions of restrial Animals, Fifth Ed., Office each serum by transferring 50 micro- International des Epizooties, pp 842– liters (0.05cc.) of diluted serum from 855, 2004; and §§ 147.15 and 147.16. one well to the next using twelve 50 (a) The status of a flock for Myco- microliter microdiluters fitted in a plasma shall be determined according multimicrodiluter handle. When trans- to the following criteria: fers have been made to all of the wells of the desired series, the 50 microliters (1) If the tube agglutination test, en- remaining in the microdiluters are re- zyme-labeled immunosorbent assay moved by blotting, touching the micro- (ELISA), official molecular examina- diluters to the surface of the distilled tion procedure, or serum plate test is water wash, and blotting again. negative, the flock qualifies for the (5) Dilute the desired microtest anti- classification for which it was tested. gen with 0.50 percent phenolized saline (2) If the tube agglutination, ELISA, and add 50 microliters (0.05 cc.) to each or serum plate test is positive, the microplate well. hemaglutination inhibition (HI) test or (6) Seal each plate with a plastic a molecular examination procedure sealer or place the unsealed micro- shall be conducted: Provided, for the HI plates in a tight incubation box and in- test, that if more than 50 percent of the cubate at 37 °C. for 18–24 hours. samples are positive for M. (7) Read the test results as described gallisepticum, M. meleagridis, or M. in paragraph (f) of this section. synoviae, the HI test shall be conducted (f) Read the test results with the aid on 10 percent of the positive samples or of a reading mirror. Results are inter- 25 positive samples, whichever is great- preted as follows: er. HI titers of 1:40 or more may be in- (1) N, or ¥ (negative) when the terpreted as suspicious and appropriate microplate well has a large, distinct antigen detection samples should be button of stained cells; or taken promptly (within 7 days of the (2) P, or + (positive) when the original sampling) from 30 clinically microplate well reveals no antigen but- affected birds and examined by an ap- ton; or proved cultural technique individually, (3) S, or ? (suspicious) when the or pooled (up to 5 swabs per test) and microplate well has a small button. used in a molecular examination proce- Suspicious reactions may tend to be dure or in vivo bioassay.

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(3) If the in vivo bioassay, molecular ducted with 4 HA units. Titers of 1:80 or examination procedure, or culture pro- greater for both chicken and turkey cedure is negative, the Official State sera are considered positive, while a Agency may qualify the flock for the 1:40 or 1:20 titer would be strongly sus- classification for which it was tested. picious and additional tests should be In the event of contaminated cultures, required. the molecular examination technique (a) Serum plate agglutination test. (1) must be used to make a final deter- The serum plate agglutination test for mination. mycoplasma is conducted by con- (4) If the in vivo bioassay, molecular tacting and mixing 0.02 ml of test examination procedure, or culture pro- serum with 0.03 ml of serum plate anti- cedure is positive, the flock will be considered infected. gen on a glass at room temperature. (b) [Reserved] The standard procedure is: (i) Allow antigen and test serums to [40 FR 1504, Jan. 8, 1975. Redesignated at 44 warm up to room temperature before FR 61586, Oct. 26, 1979] use. EDITORIAL NOTE: For FEDERAL REGISTER ci- (ii) Dispense test serums in 0.02 ml tations affecting § 147.6, see the List of CFR amounts with a pipette or standardized Sections Affected, which appears in the 1 Finding Aids section of the printed volume loop (rinsed between samples) to 1 ⁄2 and at www.fdsys.gov. inch squares on a ruled glass plate. Limit the number of samples (no more § 147.7 Standard test procedures for than 25) to be set up at one time ac- mycoplasma. 5 cording to the speed of the operator. The serum plate agglutination test, Serum should not dry out before being the tube agglutination test, and the en- mixed with antigen. zyme-linked immunosorbent assay (iii) Dispense 0.03 ml of antigen be- (ELISA) test should be considered basic side the test serum on each square. screening tests for mycoplasma anti- Hold antigen dispensing bottle bodies. The test selected will depend on vertically. preference, laboratory facilities, and (iv) Mix the serum and antigen, using availability of antigen. These three a multimixing device if large numbers tests, though quite accurate, determine are to be run at one time. flock status rather than individual bird status, since occasional reactions are (v) Rotate the plate for 5 seconds. At nonspecific. Under normal cir- the end of the first minute, rotate the cumstances, the rate of such nonspe- plate again for 5 seconds and read 55 cific reactions is low. Nonspecific reac- seconds later. tions may occasionally be high, par- (2) A positive reaction is character- ticularly after the use of erysipelas ized by the formation of definite bacterin in turkeys and where myco- clumps, usually starting at the periph- plasma antibodies are present for ery of the mixture. Most samples that closely related mycoplasma other than are highly positive will react well for the species being tested. The within the 2-minute test period. Reac- hemagglutination inhibition (HI) test tions thereafter should be considered is too cumbersome for routine screen- negative, although partial agglutina- ing use. Positive reactions are ex- tion at 3 and 5 minutes may warrant tremely accurate however, and are use- further retesting. High-quality antigen ful in evaluating serum samples that contacted with negative serum will react with the ELISA, plate, and/or usually dry up on the plate without tube antigens. The test should be con- visible clumping. Whenever samples are run, the antigen should be tested 5 For additional information on myco- against known positive and negative plasma test procedures, refer to the fol- control serums. Standard reference lowing references: Proc. 77th Annual Meet- antigens and negative and positive ing, U.S. Animal Health Association, 1973; Isolation and Identification of Avian Patho- titered sera are available from the Na- gens, 3rd Edition; Methods for Examining tional Veterinary Services Labora- Poultry Biologics and for Identifying and tories (NVSL), P.O. Box 884, Ames, Quantifying Avian Pathogens, 1991. Iowa 50010.

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(3) Since it is difficult to measure The pH of the buffered phenolized sa- uniform amounts of serum with a cali- line will be 7.1–7.2 if all reagents are ac- brated loop, this technique should not curately measured. The stock tube be used in conducting an official test. antigen is diluted 1:20 with buffered (b) Serum plate dilution test. (1) The phenolized saline. The procedures for serum plate dilution (SPD) test may be the tube test are as follows: used to evaluate possible nonspecific (i) Rack 12×75 mm clean tubes and reactions, gain additional information identify the tubes according to the to evaluate positive plate tests occur- sample to be tested. ring in an unexpected manner, and/or (ii) Add 0.08 ml of the individual test to evaluate the level of mycoplasma serum to each tube. This will create antibodies present in the serum sam- approximately a 1:12.5 screening dilu- ple. If sufficient serum is available, the tion of test serum when 1.0 ml of di- following method would provide the diluted antigen is added. The use of a lutions required to conduct the test. pipetting device will insure proper mix- (i) Rack three tubes and put 0.8 ml of ing of serum and antigen. phosphate-buffered saline (PBS) in (iii) To interpret positive reactions tube 1 and 0.5 ml of PBS in tubes 2 and to the 1:12.5 dilution, two additional di- 3. lutions may be made by adding 0.04 ml (ii) Pipette 0.2 ml of the test serum of serum for 1:25 dilution and 0.02 ml of into tube 1 and discard the pipette. serum for 1:50 dilution, with the addi- (iii) With a pipette, mix the serum tion of 1.0 ml of diluted antigen as indi- and PBS in tube 1 and withdraw 0.5 ml cated in paragraph (c)(1)(ii) of this sec- and add to tube 2. tion. (iv) Repeat the process in step (iii), (iv) Shake racks and incubate test mixing the contents of tube 2 and systems for 18–24 hours at 37 °C. transferring 0.5 ml to tube 3. (2) Tests are read against a dark (v) Conduct the test, as described for background under indirect fluorescent the serum plate test in paragraph (a), light. Regarded as a positive reaction on the undiluted sample and on sam- is a clearing of the supernatant fluid, ples in tubes 1, 2, and 3 after proper with visible sediment in the bottom of mixing of each dilution. the tube. Incomplete reactions are sus- (vi) To assist in the evaluation of the pect. Positive and negative control se- test, conduct concurrent SPD tests rums should be incorporated into each using both positive 1:80 and positive day’s run of tests. Reactions at 1:25 or 1:160 HI sera for the mycoplasma being greater are considered positive. They tested. The antigen should be pretested should be confirmed by the HI test. In- for reactivity with standard serum at cubation for periods greater than 24 the 1:5 and 1:10 dilution. hours may be helpful in evaluating sus- (vii) Interpretation of the SPD test picious reactions and need for possible results should be based on the criteria retesting or other diagnostic tests. in § 147.6(a). (d) Hemagglutination Inhibition (HI) (c) Tube agglutination test. (1) The test. The mycoplasma HI test is con- mycoplasma tube agglutination test is ducted by the constant-antigen, de- conducted by mixing 0.08 ml of test creasing-serum method. This method serum with 1.0 ml of diluted (1:20) anti- requires using a 4-hemagglutination gen in a tube and allowing the mixture (HA) unit of diluted antigen. Dif- to react for 18–24 hours at 37 °C. The ferences in the number of HA units diluent will be the standard phosphate- used will change the titers of positive buffered saline with phenol. This solu- sera markedly. Standard HA antigens tion is made up as follows: for Mycoplasma gallisepticum, M. synoviae, and M. meleagridis are avail- Grams able from NVSL. The antigen has been titrated and diluted to approximately Sodium hydroxide (C.P.) ...... 0 .15 Sodium chloride (C.P.) ...... 8 .5 1:640. The HA titration of each sample Potassium dihydrogen phosphate (KH2 PO4) should be checked as described in para- (C.P.) ...... 0 .68 graph (d)(2) on initial use or after long Phenol (Crystal) (C.P.) ...... 2.5 storage. To maintain HA activity, the Distilled water to make 1,000 ml undiluted HA antigen should be stored

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at ¥60 to ¥70 °C. The test procedures 5 parts Alsever’s solution (e.g., 8 ml are illustrated in Tables 2 and 3 of this blood in 40 ml of Alsever’s solution). paragraph. Centrifuge the blood suspension at 1,000 (1) Preparation of materials. (i) Prepare rpm for 10 minutes and remove the phosphate-buffered saline (PBS) as fol- Alsever’s solution or supernatant with lows: a pipette. (iv) Wash the RBC’s two times in 10 Grams or more parts of Alsever’s solution, Sodium hydroxide (C.P.) ...... 0 .15 centrifuging after each washing. Cen- Sodium chloride (C.P.) ...... 8 .5 trifugation is at 1,000 rpm for 10 min- Potassium dihydrogen phosphate (KH2 PO4) utes. The supernatant fluid is removed (C.P.) ...... 0 .68 Distilled water to make 1,000 ml and the RBC deposit resuspended to give a 25 percent suspension of packed The pH of the PBS will be 7.1–7.2 if all RBC’s in Alsever’s solution. (In testing reagents are accurately measured. either chicken or turkey sera, the ho- (ii) Collect the turkey or chicken red mologous RBC system must be used; blood cells (RBC’s) in Alsever’s solu- i.e., use chicken cells when testing tion which has been prepared as fol- chicken serum and turkey cells when lows: testing turkey serum.) If this suspension is kept refrigerated, it should keep Grams for 7 or 8 days after the blood has been collected. Sodium citrate ...... 8.0 Sodium chloride ...... 4.2 (v) For the test, 1 ml of the 25 per- Dextrose ...... 20.5 cent RBC’s is added to 99 ml of buffered Distilled water to make 1,000 ml. saline to make a 0.25 percent RBC suspension. The sodium citrate and sodium chlo- (2) Hemagglutination (HA) antigen ti- ride are dissolved in 800 ml distilled tration. The HA stock antigen is stored water and sterilized at 15 lbs. pressure at ¥70 °C in PBS buffer containing 25 for 15 minutes. Dissolve the dextrose in percent glycerin (vol/vol) in a con- 200 ml distilled water, sterilize by Seitz centrated suspension (i.e., 320–640 HA or other type of filtration and then add units/ml) in screwtype vials. Under aseptically to the sterile sodium cit- such conditions, potency will be re- rate and sodium chloride solution. tained for years. There will be a rapid (iii) From a turkey(s) or chicken(s) loss of titer if improperly stored. The known to be free of the mycoplasma titer of HA antigen is determined as il- being tested, withdraw sufficient blood lustrated in Table 1 and described in with a syringe containing Alsever’s so- paragraphs (d)(2)(i) through (x) of this lution to give a ratio of 1 part blood to section.

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(i) Rack a series of 11 chemically PBS/RBC control tube have settled clean 12×75 mm test tubes. Label the into a compact button at the bottom of tubes 1–11 left to right. the tube. (ii) Put 0.8 ml of PBS in tube 1 and (viii) If turkey sera is also to be test- 0.5 ml of PBS in each of tubes 2–11. ed for HI titer, repeat steps outlined in (iii) Add 0.2 ml of antigen to tube 1. paragraphs (d)(2)(i) through (vii) of this This will make a 1:5 dilution of anti- section, using 0.25 percent turkey gen. Discard pipette. RBC’s. (iv) Mix contents of tube 1 thor- (ix) The end point of the titration is oughly with a clean pipette, and trans- the highest dilution of antigen that fer 0.5 ml to tube 2. This will make a produces complete agglutination of the 1:10 dilution of antigen in tube 2. Dis- RBC’s, as evidenced by the formation card pipette. of a thin sheet of cells covering the (v) Continue making serial twofold concave bottom of the tube. For exam- dilutions of antigen, changing pipettes ple, if complete agglutination is pro- after each transfer, through tube 10. duced through tube 8 (a dilution of This will result in a series of twofold 1:640 of antigen), the antigen would be dilutions ranging from 1:5 to 1:2560. said to titer 640, the reciprocal of the Discard 0.5 ml of antigen dilution from dilution. tube 10. (x) Specificity of HA antigen should (vi) Add 0.5 ,ml of 0.25 percent RBC’s be determined by conducting HI tests to tubes 1–11. Tube 11 will serve as PBS/ with specific chicken sera of variable RBC control. HI titers. Specific turkey sera of vary- (vii) Shake the rack and incubate at ing HI titers should be used if turkey room temperature until the cells in the sera is also to be tested.

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(3) Reagents for mycoplasma HI test. (i) (v) Positive control serum of known Eight-unit antigen (Dilution factor for titer (should be from the same species stock antigen is established by dividing as the unknown). titer by 8; i.e., 640 antigen is diluted (vi) Negative control serum (should 1:80 in PBS to make 8-unit antigen.) be from the same species as the un- (ii) Four-unit antigen (made by dilut- known). ing surplus 8-unit antigen 1:2 with (vii) Solution of 0.25 percent washed PBS). RBC’s. (iii) PBS at pH 7.0. (4) Test outline. (i) Rack 10 chemically (iv) Unknown test serums. clean 12×75 mm tubes for each serum,

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including controls, to be tested. Iden- gen reaction, add 0.5 ml of 0.25 percent tify each row of tubes, and label tubes washed RBC’s to each tube. Shake in each row 1–10, left to right. In row 1, racks and incubate as for HA titration. add tube 11 for a PBS/RBC control. (ix) In this test system, positive (ii) Put 0.8 ml of PBS in tube 1 of serum should inhibit the HA activity of each test row; put 0.5 ml of 8-unit anti- the antigen, while negative serum gen in tube 2 of each test row; put 0.5 should have no effect. Inhibition will ml of 4-unit antigen in each of tubes 3– be evidenced by the formation of a 10 in each test row; and put 0.5 ml of free-flowing bottom of cells in the PBS in tube 11. botton of the tube. The titer of the (iii) Add 0.2 ml of test serum to tube serum can be calculated as the recip- 1. This tube will be the serum control rocal of the highest dilution of serum in the test system. that produces complete HI. Controls (iv) Mix and make 0.5 ml transfers should read as follows: from tube 1 through tube 10. This will (A) Serum control (tube 1). Cells result in serial twofold dilutions of should settle out. serum starting with 1:5 and ending (B) PBS/RBC control (tube 11). Cells with 1:2560. Discard 0.5 ml from tube 10. should settle out. (v) Rack five tubes in which to set up (C) Antigen control. HA in tubes 1–3. an antigen control. Cells should settle out in tubes 4–5. (vi) In tube 1, put 1.0 ml of 4-unit (D) Positive and negative serum con- antigen; put 0.5 ml of PBS in tubes 2– trol. Positive control should inhibit to 5. its known titer; negative control (vii) Make 0.5 ml serial transfers should have no inhibitory effect. from tube 1 through tube 5, changing (x) With this test system and 4 units pipettes after each transfer. Discard 0.5 of antigen, HI titers of 80 or above are ml from tube 5. This will result in a se- considered positive and titers of 40 are ries of tubes respectively containing 4, strongly suspicious. However, titers of 2, 1, 1⁄2, and 1⁄4 units of antigen. 10 or 20 are usually negative. Sample (viii) After 20–30 minutes at room test results are illustrated in Table 4 in temperature to permit antibody-anti- this paragraph.

TABLE 4—SAMPLE RESULTS OF HI TESTS [Tube and Serum Dilution]

1 2 3 4 5 6 7 8 9 10 1:5 1:10 1:20 1:40 1:80 1:160 1:320 1:640 1:1280 1:2560

Serum A (HI neg.) ...... ¥ + + + + + + + + + Serum B (HI 1:40) ...... ¥ ¥ ¥ ¥ + + + + + + Serum C (HI 1:160) .... ¥ ¥ ¥ ¥ ¥ ¥ + + + + Serum D (HI 1:20) ...... ¥ ¥ ¥ + + + + + + + +, HA. ¥, no HA or HI.

(xi) If serological results from agglu- (i) Materials needed. (A) Microtiter tination tests complemented by the HI equipment (minimal); i.e., microplates, test are inconclusive, cultural exam- microdiluters, micropipettes, go-no-go ination, bio-assay, or retesting of sam- diluter delivery tester, (0.05 ml). ples after an interval of at least 21 days (B) Phosphate-buffered saline (PBS). may be indicated. (C) Reagents from NVSL; i.e., HA (e) Procedure for mycolplasma antigen and negative and positive hemagglutination inhibition tests using titered sera for the mycoplasma to be microtiter technique—(1) Procedure No. 1. tested. The microtiter mycoplasma HI test (D) Homologous red blood cells was developed from the tube HI test de- (RBC’s) suspension 0.5 percent (2 ml of scribed in § 147.7(d). Refer to these pro- 25 percent RBC’s to 98 ml of PBS) ob- cedures for preparation of materials tained from birds free of the myco- not listed below. plasma to be tested. (See paragraphs

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(d)(1)(ii) through (v) of this section for (E) Add 0.05 ml of 8-unit antigen to preparation of RBC’s.) well 2 in each row. (ii) Microtiter hemagglutination (HA) (F) Add 0.05 ml of 4-unit antigen to antigen titration. (A) Mark off two rows well 3 through 8 for each row. of 10 wells each for antigen titer (HA is (G) For each serum to be tested, load done in duplicate). 0.05 ml diluter with 1:5 dilution as pre- (B) Mark last well in each row for pared in paragraph (iii) above and place cell controls. in first well of row. (C) Prepare in small test tube (12×75 (H) Mix well and transfer loaded di- mm) a starting dilution of antigen by luter to well 2. Continue serial twofold combining 0.1 ml antigen with 0.9 ml dilutions through well number 8. PBS. This is a 1:10 dilution. (I) Well 1 (serum dilution of 1:10) is (D) Add 0.05 ml PBS to all wells, in- serum control. Well 2=1:20 dilution; cluding cell controls. well 3=1:40 dilution; well 4=1:80 dilution; well 5=1:160 dilution; well 6=1:320 (E) Add 0.05 ml antigen (1:10 dilution) dilution; well 7=1:640 dilution; and well with diluters to the first well in both 8=1:1280 dilution. rows, mix thoroughly, transfer diluter (J) ( ) Mark off 6 to second well of each row and mix, Antigen control. 1 wells for antigen controls. continuing through the 10th well of ( ) Add 0.05 ml PBS to wells 2, 3, 4, 5, each row. With mixture in diluter from 2 and 6. last well, check diluter on go-no-go ( ) Add 0.05 ml 8-unit antigen to wells card, then place diluter in distilled 3 1 and 2. water. If diluter checks out, antigen di- ( ) With empty diluter, mix contents lution will be 1:20, 1:40, 1:80, 1:160, 1:320, 4 of well 2. Continue serial twofold dilu- 1:640, 1:1280, 1:2560, 1:5120. tions through well 6. (F) Add 0.05 ml of 0.5 percent RBC (5) Well 1 contains 8 units; well 2 con- suspension to all wells using a 0.05 tains 4 units; well 3 contains 2 units; dropper. well 4 contains 1 unit; well 5 contains (G) Seal plate (if plate is to be held 1⁄2 unit; and well 6 contains 1⁄4 unit. over 2 hours); shake and allow to stand (6) Mark off two wells for cell con- at room temperature until cells in cell trols and add 0.05 ml PBS to each. control gather in compact button. The (7) After 20–30 minutes at average titer is the highest dilution in which room temperature (20–23 °C) to permit agglutination is complete. The dilution antibody-antigen reaction, add 0.05 ml contains 1 HA unit in 0.05 ml. of a 0.5 percent suspension of RBC’s to (H) Prepare a dilution of antigen all wells. which contains 8 HA units in 0.05 ml. (8) Seal all wells (if wells are to be Example: if the antigen titer is 1:640, held over 2 hours). Shake the plate then that dilution contains 1 HA unit thoroughly. ÷ per 0.05 ml. Then 640 8=80, or a dilution (9) Incubate at room temperature for of 1:80 containing 8 HA units. Or 30–45 minutes. ÷ 640 4=160, a dilution of 1:160 containing (K) Interpretation: The HI titer is the 4 HA units per 0.05 ml. highest serum dilution exhibiting com- (iii) Microtiter HI test. (A) Prepare two plete inhibition of hemagglutination as dilutions of antigen, one containing 8 indicated by flowing of cells when the HA units per 0.05 ml and one con- plate is tilted. Serum having a titer of taining 4 HA units per 0.05 ml. The 4- 1:80 or greater is considered positive. A unit antigen can be prepared from the titer of 1:40 or 1:20 is suspicious. 8-unit antigen by mixing with equal (2) Procedure No. 2. Purpose: To test parts of PBS. for antibodies to avian mycoplasma by (B) Mark off one row of 8 wells for hemagglutination inhibition (HI). The each test. test uses the constant antigen, titered- (C) Prepare a 1:5 dilution of each sera sera method for measuring antibodies to be tested in a small test tube (12×75 to M. gallisepticum, M. synoviae, or M. mm): 0.1 ml serum plus 0.4 ml PBS or meleagridis. 0.05 ml serum plus 0.20 ml PBS. (i) Materials needed. (A) M. (D) Add 0.05 ml PBS with the 0.05 ml gallisepticum, M. synoviae, and/or M. dropper to the first well in each row. meleagridis HI antigens.

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(B) Positive and negative control (F) With an Oxford doser, add 25 μL of sera. 4 HA unit antigen to wells B through (C) Phosphate buffered saline (PBS). H. Well A serves as sera control. (D) Microtiter plates, 96-well, U-bot- (G) Prepare an antigen backtitration tom. by adding 25 μL of PBS to each well of (E) 12-channel pipettor (Titerek). one column. Add 25 μL of diluted anti- (F) 50 μL pipettor (Pipetman P200). gen to well A and serially dilute 25 μL (G) Pipette tips. from wells A to D. This prepares 1:2, (H) 0.5 percent homologous red blood 1:4, 1:8, and 1:16 dilutions. (It is rec- cells (RBC’s) in PBS (use RBC’s from ommended that the antigen control the same species being tested). backtitration be performed before the (I) Plate-sealing tape. diluted antigen is used in the assay. Di- (J) Mirrored plate reader. lution problems could be detected and (ii) Microtiter hemagglutination antigen corrected before the inappropriately di- (HA) titration. (A) Perform standard luted antigen is used in the assay.) hemagglutination test (HA) on myco- (H) Leave a column of wells blank for plasma antigen to determine titer of an RBC control. antigen. (I) Agitate gently and incubate for 30 (1) Dispense 50 μL of PBS into each minutes at room temperature. well of 3 rows of a 96-well microtiter (J) Add 50 μL of 0.5 percent RBC’s to plate. all wells. Note: Do not agitate after (2) Dispense 50 μL of stock antigen RBC’s have been added (agitation may into the wells of 2 rows. result in false positive reactions by (3) Perform serial two-fold dilutions causing the RBC’s to fall, resulting in (50 μL) using a 12-channel pipettor. The ‘‘false’’ buttons). dilution series will be from 1:2 to 1:4096. (K) Cover the plate with sealing tape. (4) Add 50 μL of 0.5 percent homolo- Incubate at room temperature for 30 gous RBC’s to each well of all 3 rows. minutes or until control RBC’s give a The row with no antigen serves as an tight button. RBC control. (L) Read the reaction on a mirrored (B) Incubate at room temperature plate reader. (approximately 30 minutes) until the (iv) Results. (A) The titer is reported control RBC’s give tight buttons. The as the reciprocal of the last dilution to HA titer is read as the last well to give give a tight button of RBC’s. The final a complete lawn (hemagglutination). dilution scheme includes the antigen in (C) Dilute stock antigen to 4 HA the dilution calculation and is as fol- units for the HI test. The dilution re- lows: B=1:20, C=1:40, D=1:80, E=1:160, quired to give 4 HA units is calculated F=1:320, G=1:640, H=1:1,280. by dividing the stock antigen HA titer (B) For the assay to be valid: by 8. (Example: 1:320 HA units ÷ 8 = 40, (1) The positive control sera must dilute stock antigen 1:40.) give a result within one dilution of the (iii) Hemagglutination inhibition assay. previously determined titer. (A) Label one column (A to H) of a 96- (2) The negative control sera must be well, U-bottom microtiter plate for negative. each sample, each positive and nega- (3) The backtitration of the antigen tive control sera, antigen must be 1:4 or 1:8. backtitration, and RBC control. (4) The RBC control must give tight, (B) Add 40 μL of PBS to the top row non-hemolyzed buttons. of wells (row A) of the plate. (5) Sera controls (well A of each test (C) Add 25 μL of PBS to all remaining sera) must not have non-specific agglu- wells of the plate. tination or hemolysis. If negative, re- (D) Add 10 μL of each test sera to well port as ‘‘negative with non-specific ag- A of each column (making a 1:5 sera di- glutination or non-specific hemolysis’’ lution). or ‘‘unable to evaluate due to non-spe- (E) Serially dilute 25 μL from well A cific agglutination or hemolysis’’ or through H using a 12-channel pipettor. treat the serum to remove the non-spe- Discard the final 25 μL. Row A = cific agglutination and repeat the test. 1:5...row H = 1:640. (See paragraph (e)(2)(v) of this section.)

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(v) Treatment to remove non-specific ag- and must be delivered to an authorized glutination—(A) Purpose. Treatment of laboratory for preparation for diag- serum to remove non-specific aggluti- nostic testing. nation that is interfering with HI as- (b) The authorized laboratory must says. identify each egg as to the breeding (B) Specimen. Serum. flock and pen from which it originated, (C) Materials. Homologous RBC’s and maintain this identity through (chicken or turkey), 50 percent solution each of the following: PBS, centrifuge, incubator, 4C (refrig- (1) Crack the egg on the round end erator). with a blunt instrument. (D) Procedure. (1) Prepare a 1:5 dilu- (2) Place the contents of the egg in tion of test serum by adding 50 μL of an open dish (or a receptacle to expose serum to 200 μL of PBS. the yolk) and prick the yolk with a (2) Prepare a 50 percent solution of needle. RBC’s by adding equal volumes of (3) Using a 1 ml syringe without a packed RBC’s to PBS. Mix well. needle, aspirate 0.5 ml of egg yolk from (3) Add 25 μL of 50 percent RBC solu- the opening in the yolk. tion to the serum dilutions. (4) Dispense the yolk material in a (4) Vortex gently to mix. tube. Aspirate and dispense 0.5 ml of (5) Incubate at 4 °C for 1 hour. PBS (phosphate-buffered saline) into (6) Centrifuge to pellet the RBC’s. the same tube, and place in a rack. (7) Use the supernatant to perform (5) After all the eggs are sampled, the HI assay. Modify the dilution place the rack of tubes on a vortex scheme in the assay to consider the ini- shaker for 30 seconds. tial 1:5 dilution prepared in the treat- (6) Centrifuge the samples at 2500 ment. For the 1:5 dilution scheme, do RPM (1000×g) for 30 minutes. not add PBS to row A. Add 50 μL of the (7)(i) For egg yolk samples being 1:5 treated supernatant to row A. Seri- tested to retain the U.S. M. ally dilute 25 μL from rows A through Gallisepticum Clean and U.S. M. H. This prepares a serum dilution of Synoviae Clean classifications, test the 1:10 through 1:640 in rows B through H. resultant supernatant for M. gallisepticum and M. synoviae by using [49 FR 19803, May 10, 1984, as amended at 57 FR 57342, Dec. 4, 1992; 59 FR 12799, Mar. 18, test procedures specified for detecting 1994; 63 FR 3, Jan. 2, 1998; 67 FR 8469, Feb. 25, IgG antibodies set forth for testing 2002; 72 FR 1425, Jan. 12, 2007] serum in § 147.7 (for these tests the resultant supernatant would be sub- § 147.8 Procedures for preparing egg stituted for serum); except that a sin- yolk samples for diagnostic tests. gle 1:20 dilution hemagglutination inhi- The following testing provisions may bition (HI) test may be used as a be used for retaining the classification screening test in accordance with the U.S. M. Gallisepticum Clean under procedures set forth in § 147.7. § 145.23(c)(1)(ii)(C) and (ii) For egg yolk samples being tested § 145.33(c)(1)(ii)(C), for retaining the to retain the U.S. H5/H7 Avian Influ- classification U.S. M. Synoviae Clean enza Monitored classification, test the under § 145.23(e)(1)(ii)(b) and resultant supernatant in accordance § 145.33(e)(1)(ii)(b), and for retaining the with the requirements in § 146.13(b). classification U.S. H5/H7 Avian Influ- NOTE: For evaluating the test results of enza Monitored under § 146.23(a), any egg yolk test, it should be remembered § 146.33(a), and § 146.44(a) of this chap- that a 1:2 dilution of the yolk in saline was ter. made of the original specimen. (a) Under the supervision of an Au- [50 FR 19900, May 13, 1985; 63 FR 3, Jan. 2, thorized Agent or State Inspector, the 1998, as amended at 71 FR 56333, Sept. 26, eggs which are used in egg yolk testing 2006] must be selected from the premises where the breeding flock is located, § 147.9 Standard test procedures for must include a representative sample avian influenza. of 30 eggs collected from a single day’s (a) The agar gel immunodiffusion production from the flock, must be (AGID) test should be considered the identified as to flock of origin and pen, basic screening test for antibodies to

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Type A influenza viruses. The AGID or 60 × 15 mm petri dishes, flexible vac- test is used to detect circulating anti- uum tubing, side-arm flask (500 mL or bodies to Type A influenza group-spe- larger), and a 12- or 14-gauge blunt- cific antigens, namely the ended cannula. ribonucleoprotein (RNP) and matrix (2) Reagents needed. (i) Phosphate (M) proteins. Therefore, this test will buffered saline (PBS), 0.01M, pH 7.2 detect antibodies to all influenza A vi- (NVSL media #30054 or equivalent). ruses, regardless of subtype. The AGID (ii) Agarose (Type II Medium grade, test can also be used as a group-specific Sigma Chemical Co. Cat.# A–6877 or test to identify isolates as Type A in- equivalent). fluenza viruses. The method used is (iii) Avian influenza AGID antigen similar to that described by Beard. 6 and positive control antiserum ap- The basis for the AGID test is the con- proved by the Department and the Offi- current migration of antigen and anti- cial State Agency. bodies toward each other through an (iv) Strong positive, weak positive, agar gel matrix. When the antigen and and negative control antisera approved specific antibodies come in contact, by the Department and the Official they combine to form a precipitate State Agency (negative control that is trapped in the gel matrix and antisera optional). produces a visible line. The precipitin (3) Preparing the avian influenza AGID line forms where the concentration of agar. (i) Weigh 9 gm of agarose and 80 antigen and antibodies is optimum. gm of NaCl and add to 1 liter of PBS Differences in the relative concentra- (0.01 M, pH 7.2) in a 2 liter Erlenmeyer tion of the antigen or antibodies will flask. shift the location of the line towards (ii) To mix the agar, either: the well with the lowest concentration (A) Autoclave the mixture for 10 min- or result in the absence of a precipitin utes and mix the contents by swirling line. Electrolyte concentration, pH, after removing from the autoclave to temperature, and other variables also ensure a homogeneous mixture of in- affect precipitate formation. gredients; or (1) Materials needed. (i) Refrigerator (B) Dissolve the mixture by bringing (4 °C). to a boil on a hot plate using a mag- (ii) Freezer (¥20 °C). (iii) Incubator or airtight container netic stir bar to mix the contents in for room temperature (approximately the flask while heating. After boiling, 25 °C) incubations. allow the agar to cool at room tem- ° (iv) Autoclave. perature (approximately 25 C) for 10 to (v) Hot plate/stirrer and magnetic 15 minutes before dispensing into petri stir bar (optional). plates. (vi) Vacuum pump. (iii) Agar can be dispensed into small (vii) Microscope illuminator or other quantities (daily working volumes) and appropriate light source for viewing re- stored in airtight containers at 4 °C for sults. several weeks, and melted and dis- (viii) Immunodiffusion template cut- pensed into plates as needed. ter, seven-well pattern (a center well NOTE: Do not use agar if microbial con- surrounded by six evenly spaced wells). tamination or precipitate is observed. Wells are 5.3 mm in diameter and 2.4 mm apart. (4) Performing the AGID—(i) Detection (ix) Top loading balance (capable of of serum antibodies. (A) Dispense 15 to 17 × measuring 0.1 gm differences). mL of melted agar into a 100 15 mm (x) Pipetting device capable of deliv- petri plate or 5 to 6 mL agar into a 60 × ering 50μl portions. 15 mm petri plate using a 25 mL pi- (xi) Common laboratory supplies and pette. The agar thickness should be ap- glassware—Erlenmeyer flasks, grad- proximately 2.8 mm. uated cylinders, pipettes, 100 × 15 mm (B) Allow plates to cool in a relatively dust-free environment with the 6 Beard, C.W. Demonstration of type-spe- lids off to permit the escape of water cific influenza antibody in mammalian and vapor. The lids should be left off for at avian sera by immunodiffusion. Bull. Wld. least 15 minutes, but not longer than 30 Hlth. Org. 42:779–785. 1970. minutes, as electrolyte concentration

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of the agar may change due to evapo- paper towel in the incubation chamber. ration and adversely affect formation Note: Temperature changes during mi- of precipitin lines. gration may lead to artifacts.

NOTE: Plates should be used within 24 (ii) Interpretation of test results. (A) hours after they are poured. Remove the lid and examine reactions from above by placing the plate(s) over (C) Record the sample identification, a black background, and illuminate the reagent lot numbers, test date, and plate with a light source directed at an identification of personnel performing angle from below. A microscope illu- and reading the test. minator works well and allows for (D) Using the template, cut the agar varying intensities of light and posi- after it has hardened. Up to seven template patterns can be cut in a 100×15 tions. mm plate and two patterns can be cut (B) The type of reaction will vary in a 60×15 mm plate. with the concentration of antibody in (E) Remove the agar plugs by aspira- the sample being tested. The positive tion with a 12- to 14-gauge cannula con- control serum line is the basis for read- nected to a side arm flask with a piece ing the test. If the line is not distinct, of silicone or rubber tubing that is con- the test is not valid and must be re- nected to a vacuum pump with tubing. peated. The following types of reac- Adjust the vacuum so that the agar tions are observed (see figure 3): surrounding the wells is not disturbed (1) Negative reaction. The control lines when removing the plugs. continue into the test sample well (F) To prepare the wells, place 50 μl without bending or with a slight bend of avian influenza AGID antigen in the away from the antigen well and toward center well using a micropipette with the positive control serum well. an attached pipette tip. Place 50 μl AI (2) Positive reaction. The control lines AGID positive control antiserum in join with, and form a continuous line each of three alternate peripheral (line of identity) with, the line between wells, and add 50 μl per well of test sera the test serum and antigen. The loca- in the three remaining wells. This ar- tion of the line will depend on the con- rangement provides a positive control centration of antibodies in the test line on each side of the test serum, serum. Weakly positive samples may thus providing for the development of not produce a complete line between lines of identity on both sides of each the antigen and test serum but may test serum (see figure 1). only cause the tip or end of the control NOTE: A pattern can be included with posi- line to bend inward toward the test tive, weak positive, and negative reference well. serum in the test sera wells to aid in the in- (3) Non-specific lines. These lines occa- terpretation of results (see figure 2). sionally are observed between the anti- (G) Cover each plate after filling all gen and test serum well. The control wells and allow the plates to incubate lines will pass through the non-specific for 24 hours at room temperature (ap- line and continue on into the test proximately 25 °C) in a closed chamber serum well. The non-specific line does to prevent evaporation. Humidity not form a continuous line with posi- should be provided by placing a damp tive control lines.

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(b) The enzyme-linked Subpart B—Bacteriological immunosorbent assay (ELISA) may be Examination Procedure used as a screening test for avian influenza. Use only federally licensed § 147.10 Laboratory procedure rec- ELISA kits and follow the manufactur- ommended for the bacteriological er’s instructions. All ELISA-positive examination of egg-type breeding serum samples must be confirmed with flocks with salmonella enteritidis the AGID test conducted in accordance positive environments. with paragraph (a) of this section. Birds selected for bacteriological examination from egg-type breeding [65 FR 8019, Feb. 17, 2000, as amended at 74 flocks positive for Salmonella enteritidis FR 14718, Apr. 1, 2009] after environmental monitoring should EDITORIAL NOTE: At 74 FR 14718, Apr. 1, be examined as described in § 147.11(a) 2009, § 147.9 was amended by removing figure of this subpart, with the following ex- 1 and redesignating figures 2 and 3 as figures ceptions and modifications allowed due 1 and 2, respectively. However, all three figures are parts of illustrations, and this to the high number of birds required amendment could not be incorporated. for examination: (a) Except when visibly pathological tissues are present, direct culture, § 147.11(a)(1) of this subpart, may be omitted; and (b) Enrichment culture of organ (non- intestinal) tissues using a non- selec- tive broth, § 147.11(a)(2) of this subpart, may be omitted. [59 FR 12801, Mar. 18, 1994]

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§ 147.11 Laboratory procedure rec- and tissues for selective enrichment ommended for the bacteriological culture. examination of salmonella. (2) Selective enrichment culture (a) For egg- and meat-type chickens, (refer to illustration 1). Collect and turkeys, waterfowl, exhibition poultry, culture organ samples separately from and game birds. All reactors to the pul- intestinal samples, with intestinal tis- lorum-typhoid tests, up to 25 birds, and sues collected last to prevent cross- birds from Salmonella enteritidis (SE) contamination. Samples from the fol- positive environments should be cul- lowing organs or sites should be col- tured in accordance with both the di- lected for culture in selective enrich- rect enrichment (paragraph (a)(1)) and ment broth: selective enrichment (paragraph (a)(2)) (i) Heart (apex, pericardial sac, and procedures described in this section: contents if present); Provided, That in turkeys, if there are (ii) Liver (portions exhibiting lesions more than four reactors to the pul- or, in grossly normal organs, the lorum-typhoid tests in the flock, a drained gallbladder and adjacent liver minimum of four reactors as provided tissues); for in § 145.14(a)(6)(ii) of this subchapter (iii) Ovary-Testes (entire inactive shall be submitted to the authorized ovary or testes, but if ovary is active, laboratory for bacteriological examina- include any atypical ova); tion. Careful aseptic technique should (iv) Oviduct (if active, include any be used when collecting all tissue sam- debris and dehydrated ova); ples. (v) Kidneys and spleen; and (1) Direct culture (refer to illustra- (vi) Other visibly pathological sites tion 1). Grossly normal or diseased where purulent, necrotic, or prolif- liver, heart, pericardial sac, spleen, erative lesions are seen. lung, kidney, peritoneum, gallbladder, (3) From each bird, aseptically col- oviduct, misshapen ova or testes, in- lect 10 to 15 grams of each organ or site flamed or unabsorbed yolk sac, and listed in paragraph (a)(2) of this sec- other visibly pathological tissues tion. Mince, grind, or blend and place where purulent, necrotic, or prolif- in a sterile plastic bag. All the organs erative lesions are seen (including or sites listed in paragraph (a)(2) of cysts, abscesses, hypopyon, and in- this section from the same bird may be flamed serosal surfaces) should be sam- pooled into one bag. Do not pool sampled for direct culture using either ples from more than one bird. Add suf- flamed wire loops or sterile swabs. ficient tetrathionate enrichment broth Since some strains may not dependably to give a 1:10 (sample to enrichment) survive and grow in certain selective ratio. Follow the procedure outlined in media, inoculate non-selective plates illustration 1 for the isolation and (such as blood or nutrient agar) and se- identification of Salmonella. lective plates (such as MacConkey (4) From each bird, aseptically col- [MAC] and brilliant green novobiocin lect 10 to 15 grams of each of the fol- [BGN] for pullorum-typhoid and MAC, lowing parts of the digestive tract: BGN, and xylose-lysine-tergitol 4 [XLT Crop wall, duodenum, jejunum (includ- 4] for SE). After inoculating the plates, ing remnant of yolk sac), both ceca, pool the swabs from the various organs cecal tonsils, and rectum-cloaca. into a tube of non-selective broth (such Mince, grind, or blend tissues and pool as nutrient or brain-heart infusion). them into a sterile plastic bag. Do not Refer to illustration 1 for rec- pool tissues from different birds into ommended bacteriological recovery the same sample. Add sufficient tetra- and identification procedures. 7 Proceed thionate enrichment broth to give a immediately with collection of organs 1:10 (sample to enrichment) ratio. Fol- low the procedure outlined in illustration 1 for the isolation and identifica- 7 Biochemical identification charts may be tion of Salmonella. obtained from ‘‘A Laboratory Manual for the Isolation and Identification of Avian Patho- (5) After selective enrichment, inocu- gens,’’ chapter 2, Salmonellosis. Fourth edi- late selective plates (such as MAC and tion, 1998, American Association of Avian BGN for pullorum-typhoid and MAC, Pathologists, Inc., Kennett Square, PA 19348. BGN, and XLT 4) for SE. Inoculate

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three to five Salmonella-suspect colo- (6) If the initial selective enrichment nies from plates into triple sugar iron is negative for Salmonella, a delayed (TSI) and lysine iron agar (LIA) slants. secondary enrichment (DSE) procedure Screen colonies by serological (i.e., is used. Leave the tetrathionate-en- serogroup) and biochemical procedures riched sample at room temperature for (e.g., the Analytical Profile Index for 5 to 7 days. Transfer 1 mL of the cul- Enterobacteriaceae [API]) as shown in ture into 10 mL of fresh tetrathionate illustration 1. As a supplement to enrichment broth, incubate at 37 C for screening three to five Salmonella-sus- 20 to 24 hours, and plate as before. pect colonies on TSI and LIA slants, a (7) Serogroup all isolates identified group D colony lift assay may be utilized to signal the presence of hard-to- as salmonellae and serotype all detect group D Salmonella colonies on serogroup D1 isolates. Phage-type all agar plates. SE isolates.

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(b) [Reserved] ination shall be collected in accordance with the procedures described in para- (Approved by the Office of Management and Budget under control number 0579–0007) graphs (a)(1), (a)(2), or (a)(3) of this section: [36 FR 23121, Dec. 3, 1971. Redesignated at 44 (i) Procedure for sampling in broth. Au- FR 61586, Oct. 26, 1979, and amended at 47 FR 21994, May 20, 1982; 50 FR 19900, May 13, 1985; thorized laboratories will provide 57 FR 57342, Dec. 4, 1992; 59 FR 12801, Mar. 18, capped tubes 1 to 2 cm in diameter and 1994; 61 FR 11521, Mar. 21, 1996; 63 FR 3, Jan. 15 to 20 cm in length that are two- 2, 1998; 65 FR 8019, 8023, Feb. 17, 2000; 67 FR thirds full of a recently made, refrig- 8469, Feb. 25, 2002; 72 FR 1425, Jan. 12, 2007] erated, sterile enrichment broth for each sample. Sufficient tubes shall be § 147.12 Procedures for collection, iso- taken to the premises to provide at lation, and identification of Sal- monella from environmental sam- least one tube per pen or one tube per ples, cloacal swabs, chick box pa- 500 birds, whichever is greater. At least pers, and meconium samples. one sterile, cotton-tipped applicator will be needed for each tube. The dry Information concerning the pen ar- applicator is first placed in or drawn rangement and number of birds per pen should be obtained from the owner so through fresh manure (under roost, that the required number of samples near water troughs, fecal droppings, or per pen and per flock can be deter- diarrhetic droppings). After each mined. A means of identifying each streaking, place the cotton-tipped ap- sample by pen of origin should be pro- plicator in the tube of broth and swirl vided. The vehicle transporting the the applicator to remove the collected personnel taking the samples should be material. Withdraw the applicator left as far as practical from the poultry from the tube and use it to take addi- pens. Sanitary precautions, including tional specimens by streaking on or personal cleanliness, should be ob- through areas where defecation, tram- served during the sampling procedure. pling of feces, or settling of dust is The hands should be carefully washed common; e.g., on or near waterers, with a sanitizing soap prior to the sam- feeders, nests, or rafters, etc. When the pling. Outer clothing, including gloves, volume of material collected equals ap- should be changed between visits to proximately 10 percent of the volume different premises so that clean cloth- of the broth (usually 10–12 streakings), ing is worn upon entering each prem- place the applicator in the tube and ises. break the stick in half, leaving the The used and clean apparel should be lower or cotton-tipped half in the broth kept separate. Boots or footwear and retaining the upper half for future should be cleaned and disinfected be- disposal. Replace the cap on the inocu- tween visits to different premises. Dis- lated tube and continue the sampling posable caps should be provided and procedure in other areas of the pen. discarded after use on each premises. (ii) Procedure for sampling in dry con- After collection, the samples should be tainers. Place a sample of fecal mate- protected from drying, light, and exces- rial, litter, or dust in a sterile, sealable sive temperatures and delivered to the container. The sample shall consist of laboratory within one day. If delivery several specimens of material taken is delayed, samples should be refrig- from a representative location in the erated. pen or house. Collect at least 10 g (ap- (a) For egg- and meat-type chickens, proximately a heaping tablespoonful) waterfowl, exhibition poultry, and game of material for each sample. Collect birds. All samples and swabs described the specimens in each sample with a in this paragraph should be cultured in sterile tongue depressor or similar accordance with illustration 2 of uncontaminated instrument. The sam- § 147.11, including delayed secondary ples shall vary in type and consistency. enrichment. All salmonellae recovered Half of the samples shall be comprised shall be serogrouped or serotyped. of material representing defecated (1) Environmental samples. Fecal ma- matter from a large portion of the terial, litter, dust, or floor litter sur- flock; i.e., trampled, caked material face or nest box drag swab samples to near waterers and feeders. The min- be submitted for bacteriological exam- imum number of samples to be taken

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shall be determined by the following: graphs (a)(1)(i), (a)(1)(ii), or (a)(3)(iv) of Five samples from pens or houses of up this section shall also be periodically to 500 birds; Ten samples from pens or collected. houses of 500 to 2,500 birds; Fifteen (i) Drag-swab sampler assembly. Drag- samples from pens or houses with more swab (DS) samplers may be assembled than 2,500 birds. The samples may be using two 3- by 3-inch sterile gauze pooled to not fewer than five samples pads; size 20 wrapping twine; and paper at the laboratory as long as the volume clips, staples, or similar fasteners. Fold of material collected equals approxi- each gauze pad in half and attach one mately 10 percent of the volume of the pad to a 2-foot-long (60 cm) piece of broth. twine and the other to a 1-foot-long (30 (2) Cloacal swabs. Cloacal swabs for cm) piece of twine. To attach a pad to bacteriological examination shall be the twine with a paper clip, bend the taken from each bird in the flock or end wires of the paper clip slightly and from a minimum of 500 birds in accord- push them through the fabric of the ance with the procedure described in folded pad, thus securing the clips to paragraph (a)(2)(i) of this section. the folded pads; then securely tie the (i) Procedure for taking cloacal swabs. twine to the free rounded end of the The authorized laboratory will provide paper clip. To attach a pad to the twine sterile capped tubes or other suitable with a staple, staple the twine to the containers and cotton-tipped applica- pad near the center of the fold, apply- tors for use in taking the cloacal ing the staple at a right angle to the swabs. Insert the cotton-tipped appli- twine and parallel to the fold. (A pre- cator into the cloaca and rectum in tied knot in the free end of the twine such a manner as to ensure the collec- will prevent the twine from slipping tion of fecal material. Place the swab under the staple during use.) Once the and adhering fecal material in the tube pads and the twine have been attached, and break the stick in half, keeping the securely connect the free ends of both upper half of the stick for future dis- lengths of twine to a small loop tied at posal. The cloacal swabs may be com- the end of a 5-foot-long piece of twine. bined in the sterile tubes in multiples The resulting assembly resembles the of five or in combinations specified by letter Y, with a long vertical stem and the authorized laboratory. two diagonal branches of different (ii) [Reserved] lengths with a gauze pad securely at- (3) Drag-swabs. Utilization of drag tached to the end of each branch. Wrap swabs (DS) involves the exposure of the twine around each two-pad DS gauze pads (or commercially available sampler to produce a small bundle. sponges designed for this purpose), a Autoclave the assembled DS sampler key component of a DS sampler, to the bundle and transfer it with sterile for- surface of random, flock-representative ceps or other aseptic method to a re- floor litter and nest box areas. The sealable sterile bag. Aseptically add 15 sampler pads shall be sterile and mL of double-strength skim milk to slightly moist to promote adherence of the bag and massage the milk into the particulate material, and impregnated gauze pads. Seal the bags and store at with double-strength skim milk 8 to -20 °C. protect salmonella viability during (ii) Procedures and applications for DS sample collection, batching, storage, samplers. DS samplers shall be com- and shipment. Floor litter surface DS pletely thawed prior to use. Complete sample results tend to reflect the sal- pad/twine/fastener assemblies shall be monella carrier/shedder status of a used to sample floor litter surfaces; flock. Nonetheless, other environ- nest box surfaces may be sampled using mental samples as described in para- 3- by 3-inch sterile gauze pads impregnated with double-strength skim milk 8 Obtain procedure for preparing double in the manner described in paragraph strength skim milk from USDA-APHIS (a)(3)(i) of this section. In either in- ‘‘Recommended Sample Collection Methods for Environmental Samples,’’ available from stance, the Plan participant collecting the National Poultry Improvement Plan, the samples shall wear a fresh pair of Veterinary Services, APHIS, USDA, 1506 disposable sterile gloves for each flock Klondike Road, Suite 300, Conyers, GA 30094. or house sampled. Each sampler bag

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shall be marked with the type of sam- graph (a)(4)(ii) of this section. It is imple (floor litter or nest box surface) and portant that the paper be removed the identity of the house or flock from from the chick box before the box is which the sample was taken. placed in the brooding house. (iii) Floor litter sampling technique. (i) Instructions for collecting sam- For flocks with fewer than 500 breed- ples from chick box papers: ers, at least one DS set (two DS pads) (A) Collect 1 chick box paper for each shall be dragged across the floor litter 10 boxes of chicks placed in a house and surface for a minimum of 15 minutes. lay the papers on a clean surface. For flocks with 500 or more breeders, a (B) Clean your hands and put on minimum of two DS sets (four DS pads) latex gloves. Do not apply disinfectant shall be dragged across the floor litter to the gloves. Change gloves after col- surface for a minimum of 15 minutes lecting samples from 10 chick box paper DS set. Upon completion of drag- pers or any time a glove is torn. ging, lower each DS pad by its attached (C) Saturate a sterile 3-by-3 inch twine into a separate, resealable sterile gauze pad with double-strength skim bag. Alternatively, each DS set of two milk (see footnote 12 to this section) pads may be lowered by its attached and rub the pad across the surface of twine into the storage/transport bag five chick box papers. Rub the pad over from which the DS set was originally at least 75 percent of each paper and taken. Remove the twine from the pad use sufficient pressure to rub any dry or DS set by grasping the pad or DS set meconium off the paper. Pouring a through the sides of the bag with one small amount of double-strength skim hand while pulling on the twine with milk (1 to 2 tablespoons) on each paper the other hand until the connection is will make it easier to collect samples. broken. Seal the bags and promptly refrigerate them to between 2 and 4 °C. (D) After collecting samples from 10 Do not freeze. Discard the twine in an chick box papers, place the two gauze appropriate disposal bag. pads used to collect the samples (i.e., one pad per 5 chick box papers) into an (iv) Nest box or egg belt sampling tech- 18 oz. Whirl-Pak bag and add 1 to 2 ta- nique. Collect nest box or egg belt samples by using two 3-by-3 inch sterile blespoons of double-strength skim gauze pads premoistened with double- milk. strength skim milk and wiping the (E) Promptly refrigerate the Whirl- pads over assorted locations in about 10 Pak bags containing the samples and percent of the total nesting area or the transport them, on ice or otherwise re- egg belt. Upon completion, place each frigerated, to a laboratory within 48 pad in a separate, resealable sterile hours of collection. The samples may bag. Seal the bags and promptly refrig- be frozen for longer storage if the Plan erate them to between 2 and 4 °C. Do participant is unable to transport them not freeze. to a laboratory within 48 hours. (v) Culturing of litter surface and nest (ii) The Plan participant may send box samples. When refrigerated to be- chick box papers directly to a labora- tween 2 and 4 °C, pads impregnated tory, where samples may be collected with double-strength skim milk may as described in paragraph (a)(4)(i) of be stored or batched for 5 to 7 days this section. To send chick box papers prior to culturing. Pads shipped singly directly to a laboratory: or paired in a single bag shall not be (A) Collect 1 chick box paper for each pooled for culturing but shall be sepa- 10 boxes of chicks placed in a house and rately inoculated into 60 mL of selec- place the chick papers immediately tive enrichment broth. into large plastic bags and seal the (4) Chick box papers. Samples from bags. chick box papers may be bacterio- (B) Place the plastic bags containing logically examined for the presence of the chick box papers in a clean box and Salmonella. The Plan participant may transport them within 48 hours to a collect the samples in accordance with laboratory. The plastic bags do not re- paragraph (a)(4)(i) of this section or quire refrigeration. submit chick box papers directly to a (iii) The laboratory must follow the laboratory in accordance with para- procedure set forth in paragraph (a)(5)

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of this section for testing chick meco- and promptly refrigerate them at 2 to 4 nium for Salmonella. °C or place in a cooler with ice or ice (5) Chick meconium testing procedure packs. Do not freeze. Samples should for Salmonella. (i) Record the date, be stored at refrigerator temperatures source, and flock destination on the of 2 to 4 °C no more than 5 days prior ‘‘Meconium Worksheet.’’ to culturing. (ii) Shake each plastic bag of meco- (b) Isolation and identification of Sal- nium until a uniform consistency is monella. Either of the two enrichment achieved. procedures or the rapid detection (iii) Transfer a 25 gm sample of meco- method in this paragraph may be used. nium to a sterile container. Add 225 mL of a preenrichment broth to each sam- (1) Tetrathionate enrichment with ple (this is a 1:10 dilution), mix gently, delayed secondary enrichment (DSE): and incubate at 37 °C for 18–24 hours. (i) Add tetrathionate enrichment (iv) Enrich the sample with selective broth to the sample to give a 1:10 (sam- enrichment broth for 24 hours at 42 °C. ple to enrichment) ratio. Incubate the (v) Streak the enriched sample onto sample at 37 or 41.5 °C for 20 to 24 hours brilliant green novobiocin (BGN) agar as shown in illustration 2. and xylose-lysine-tergitol 4 (XLT4) (ii) After selective enrichment, inoc- agar. ulate selective plates (such as BGN and (vi) Incubate both plates at 37 °C for XLT4). Incubate the plates at 37 °C for 24 hours and process suspect Salmonella 20 to 24 hours. Inoculate three to five colonies according to paragraph (b) of Salmonella-suspect colonies from the this section. plates into triple sugar iron (TSI) and (6) Shoe cover sampling technique. Ab- lysine iron agar (LIA) slants. Incubate sorbable fabric shoe covers involve the the slants at 37 °C for 20 to 24 hours. exposure of the bottom surface of shoe Screen colonies by serological ( , covers to the surface of floor litter and i.e. slat areas. Wearing clean latex gloves, serogroup) and biochemical (e.g., API) place the shoe covers over footwear procedures as shown in illustration 2. that is only worn inside the poultry As a supplement to screening three to house. This can be footwear dedicated five Salmonella-suspect colonies on TSI to the facility or disposable overshoes. and LIA slants, a group D colony lift Each pair of shoe covers should be assay may be utilized to signal the worn while walking at a normal pace presence of hard-to-detect group D Sal- over a distance of 305 meters (1,000 monella colonies on agar plates. feet). For flocks with fewer than 500 (iii) If the initial selective enrich- breeders, at least 1 pair of shoe covers ment is negative for Salmonella, use a should be worn to sample the floor of DSE procedure. Leave the original tet- the bird area. For flocks with 500 or rathionate-enriched sample at room more breeders, at least 2 pairs of shoe temperature for 5 to 7 days. Transfer 1 covers should be worn to sample the mL of the culture into 10 mL of fresh floor of the bird area. After sampling, tetrathionate enrichment broth, incu- place each shoe cover in a sterile con- bate at 37 °C for 20 to 24 hours, and tainer with 30 ml of double strength plate as in paragraph (b)(1)(ii) of this skim milk.9 Seal the sterile containers section. 9 Obtain procedure for preparing double (iv) Serogroup all isolates identified strength skim milk from USDA–APHIS as Salmonella and serotype all ‘‘Recommended Sample Collection Methods serogroup D isolates. Phage-type all for Environmental Samples,’’ available from Salmonella enteritidis isolates. the National Poultry Improvement Plan, (2) Pre-enrichment followed by selec- Veterinary Services, APHIS, USDA, 1506 Klondike Road, Suite 300, Conyers, GA 30094. tive enrichment. (See illustration 2.)

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(3) Approved rapid detection method. beled Salmonella sandwich After selective enrichment using a immunoassay may be used to deter- PCR-based assay approved by the NPIP mine the presence of Salmonella. Posi- under § 145.15, a rapid ruthenium-lative samples from the immunoassay

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are then inoculated to selective plates ture disposal. The cap is then replaced (such as BGN and XLT4). Incubate the on the inoculated tube, and the sam- plates at 37 °C for 20 to 24 hours. Inocu- pling procedure is continued in other late three to five Salmonella-suspect areas of the pen. colonies from the plates into triple (ii) Procedure for sampling in dry con- sugar iron (TSI) and lysine iron agar tainers. A sample of fecal material, lit- (LIA) slants. Incubate the slants at 37 ter, or dust is placed in a sterile, seal- °C for 20 to 24 hours. Screen colonies by able container. The sample shall con- serological (i.e., serogroup) and bio- sist of several specimens of material chemical (e.g., API) procedures as taken from a representative location in shown in illustration 2. As a supple- the pen or house. At least 10 g (approxi- ment to screening three to five Sal- mately a heaping tablespoonful) of ma- monella-suspect colonies on TSI and terial shall be collected for each sam- LIA slants, a group D colony lift assay ple. The specimens in each sample may be utilized to signal the presence shall be collected with a sterile tongue of hard-to-detect group D Salmonella depressor or similar uncontaminated colonies on agar plates. instrument. The samples should vary (c) For turkeys—(1) Environmental sam- in type and consistency. Half of the ples. Fecal material, litter, or dust to samples should be comprised of mate- be submitted for bacteriological exam- rial representing defecated matter ination should be collected in accord- from a large portion of the flock; i.e., ance with the procedures described in trampled, caked material near paragraphs (c)(1)(i) or (c)(1)(ii) of this waterers and feeders. The minimum section: number of samples to be taken shall be (i) Procedure for sampling in broth. Au- determined by the following: thorized laboratories will provide Five samples from pens or houses of up to 500 capped tubes 1–2 cm in diameter and birds; 15–20 cm in length which are two-thirds Ten samples from pens or houses of 500 to full of a recently made, refrigerated, 2,500 birds; sterile enrichment broth (Selenite Bril- Fifteen samples from pens or houses with liant Green Sulfapyridine or Tetrathio- more than 2,500 birds. nate Brilliant Green) for each sample. The composite samples above may be Sufficient tubes should be taken to the pooled to not less than five samples at premises to provide at least one tube the laboratory as long as the volume of per pen or one tube per 500 birds, material collected equals approxi- whichever is greater. At least one ster- mately 10 percent of the volume of the ile, cotton-tipped applicator will be broth. needed for each tube. The dry appli- (2) Cloacal swabs. Cloacal swabs for cator is first placed or drawn through bacteriological examination are taken fresh manure (under roost, near water from each bird in the flock or from a troughs, cecal droppings, or diarrhetic minimum of 500 birds in accordance droppings). After this and each subse- with the procedure described in para- quent streaking, the cotton-tipped ap- graph (c)(2)(i) of this section. plicator is placed in the tube of broth (i) Procedure for taking cloacal swabs. and swirled to remove the collected The authorized laboratory will provide material. The applicator is then with- sterile capped tubes or other suitable drawn and is used for taking additional containers and cotton-tipped applica- specimens by streaking on or through tors for use in taking the cloacal areas where defecation, trampling of swabs. The cotton-tipped applicator is feces, or settling of dust are common; inserted into the cloaca and rectum in i.e., on or near waterers, feeders, nests, such a manner as to insure the collec- or rafters, etc. When the volume of mation of fecal material. The swab and terial collected equals approximately adhering fecal material is then placed 10 percent of the volume of the broth in the tube and the stick is broken in (usually 10–12 streakings), the appli- half, with the upper half retained for cator is placed in the tube and the future disposal. The cloacal swabs may stick is broken in half. The lower or be combined in the sterile tubes in cotton-tipped half is left in the broth, multiples of five or in combinations and the upper half is retained for fu- specified by the authorized laboratory.

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(ii) [Reserved] used to collect the sample over as- (3) Drag-swabs. Drag-swabs for bac- sorted locations of about 10 percent of teriological examination should in- the total nesting area. Place the gauze volve the exposure of at least six pads used to collect the sample in an unpooled pads per house to promote 18-oz whirl-pack bag containing 5 ml of representative sampling and some ele- double strength skim milk. Mark the ment of quantification. bag with the type of sample and the (i) Drag-swab assembly. Assemble house identification. drag-swab sampling sets from folded- once 3-by-3-inch sterile gauze pads se- (Approved by the Office of Management and cured with paper clips. Bend end wires Budget under control number 0579–0007) of each paper clip slightly to catch into [38 FR 13709, May 24, 1973. Redesignated at 44 the swab fabric, thus securing the clips FR 61586, Oct. 26, 1979] to the folded pads. Use two pads, as- EDITORIAL NOTE: For FEDERAL REGISTER ci- sembled as described to make each tations affecting § 147.12, see the List of CFR drag-swab sampling set. Securely con- Sections Affected, which appears in the nect one pad through the free rounded Finding Aids section of the printed volume end of the paper clip to a 2-ft (0.6 m) and at www.fdsys.gov. length of size 20 fibrous wrapping twine. Similarly connect the other pad § 147.13 Procedure for bacteriological to a 1-ft (0.3 m) length of twine. Then culturing of eggshells for colon ba- securely connect the free ends of both cilli organisms. lengths of twine to a small loop tied at Proper precautions to avoid environ- the end of a similar 5-ft length of mental contamination of the samples twine. The resulting assembly resem- during the collection and laboratory bles the letter Y with a 5-ft long process, and proper handling of the vertical stem and two diagonal samples following collection are essen- branches (one 1 ft long and the other 2 tial. Each State Inspector involved in ft long), with a folded swab securely at- eggshell culture activities must receive tached at the end of each branch. After instruction in the necessary sanitation assembly, place each two-pad drag- procedures, sampling procedures, and swab sampling set into a sterile bag. sample handling by the authorized lab- (ii) Procedure for taking drag-swab— oratory involved. The Official State (A) Floor litter: The Plan participants Agency will maintain a record showing should collect two samples as follows: that the required instruction was given Drag four 3-by-3-inch sterile gauze pads to each State Inspector. premoistened with double strength (a) Sample selection. Forty (40) eggs in skim milk 10 over the floor litter sur- the top flats of each of three randomly face for 15 min minimally. Place the selected cases of sanitized eggs from gauze pads used to collect the samples each flock will be utilized for each in 18-oz whirl-pack bags, two pads per sampling. bag with each bag containing 5 ml of (b) Swab procedure. A 2.5 centimeter double strength skim milk. This will diameter circular area of the large end maintain the moistness of the sample of each of the eggs will be rubbed with during transport. Mark the bags with a sterile swab previously moistened the type of sample and the house iden- with sterile lactose broth, or other tification. suitable liquid media provided by the (B) Nest-boxes. The Plan participant authorized laboratory. One swab will should collect one nest-box sample by be used for five eggs, and four swabs using two 3-by-3-inch sterile gauze pads will be pooled to each sterile, capped premoistened with double strength tube provided by the authorized labora- skim milk. Wipe the two gauze pads tory. (1) From the tube containing four 10 Obtain procedure for preparing double swabs and lactose broth or other suit- strength skim milk from USDA-APHIS able media, 1 ml. will be transferred to ‘‘Recommended Sample Collection Methods for Environmental Samples’’ available from 10 ml. lactose in a fermentation tube. the National Poultry Improvement Plan, (2) Incubate at 37 °C for 48 hours. The Veterinary Services, APHIS, USDA, 1506 presence of acid, and gas in the amount Klondike Road, Suite 300, Conyers, GA 30094. of 10 percent or more after 24 and 48

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hours of incubation, provides a pre- § 147.15 Laboratory procedure rec- sumptive conclusion of the presence of ommended for the bacteriological colon bacilli organisms. examination of mycoplasma reactors. 12 (Approved by the Office of Management and Budget under control number 0579–0007) (a) Turbinates, trachea, air sacs, sinuses, nasal passages, respiratory [41 FR 14256, Apr. 2, 1976. Redesignated at 44 exudates, synovial fluid, eggs (includ- FR 61586, Oct. 26, 1979, and amended at 59 FR ing yolk, yolk sacs, membranes and 12805, Mar. 18, 1994] allantoic fluid), should be directly sam- § 147.14 Procedures to determine stapled with sterile swabs. Aseptic tech- tus and effectiveness of sanitation niques are very important as some or- monitored program. ganisms may not be suppressed by the antimicrobial agents used in this pro- The following monitoring proce- cedure. Tissue suspensions from large 11 dures may be applied at the discre- volumes are sometimes desirable from tion of the Official State Agency: the sites listed above and occasionally (a) Monitor effectiveness of sanita- from the oviduct and cloaca. Tissues tion program. should be ground or blended completely (1) Culture the surface of cased eggs in 10 times their volume of Myco- periodically for fecal contaminating plasma Broth Medium (MBM). (See organisms as described in § 147.13. paragraph (f) of this section.) Speci- (2) Culture a sample of dead-in-shell mens submitted to referral labora- eggs periodically from each breeding tories in order of preference for recov- flock for coliforms. Such eggs should ery of the mycoplasma organisms are: also be cultured for the dependable re- (1) live birds, (2) refrigerated fresh tis- covery of salmonellae. Culturing for the sues, (3) tissue specimens packed with dependable recovery of salmonellae dry ice. should include the use of: (b) Inoculate 5–10 ml of MBM with a (i) Preenrichment broths supple- swab, wire loop or 0.1 ml of the tissue mented with 35 mg ferrous sulfate per suspension. When evidence of growth is 1,000 ml preenrichment to block iron- observed (lowered pH or turbidity of binding, Salmonella-inhibiting effects of broth) transfer each broth culture as egg conalbumin; and needed to maintain the original iso- (ii) Tetrathionate selective enrich- lates. Incubate tubes at 37 °C for at ment broths, competitor-controlling least 21 days before discarding as nega- plating media (XLT4, BGN, etc.), de- tive. When growth is first observed or layed secondary enrichment proce- if no growth occurs by the 4th or 5th dures, and colony lift assays detailed in day of incubation, inoculate broth cul- paragraph (a)(5) and illustration 2 of ture onto a plate of Mycoplasma Agar § 147.11. Medium (MAM). (See paragraph (g) of this section.) Several cultures may be [41 FR 48726, Nov. 5, 1976. Redesignated at 44 inoculated on one plate by using a wire FR 61586, Oct. 26, 1979, and amended at 57 FR loop or a cotton swab. Incubate plates 57343, Dec. 4, 1992; 59 FR 12805, Mar. 18, 1994; 3–5 days at 37 °C in a high humidity 59 FR 59640, Nov. 18, 1994; 61 FR 11524, 11525, chamber. If preferred, 5 percent CO Mar. 21, 1996; 65 FR 8019, Feb. 17, 2000; 74 FR 2 14718, Apr. 1, 2009; 76 FR 15797, Mar. 22, 2011] may be added or a candle jar may be used. Tiny circular and translucent colonies with elevated centers are very 11 Laboratory procedures for monitoring suggestive of mycoplasma. Indirect operations proposed here are described in the following two publications: Isolation and lighting and a low power or dissecting Identification of Avian Pathogens, American Association of Avian Pathologists, Univer- 12 Yoder, H. W., Jr., ‘‘Mycoplasmosis.’’ In: sity of Pennsylvania, New Bolton Center, Isolation and Identification of Avian Patho- Kennett Square, Pennsylvania 19348–1692, gens. (Stephen B. Hitchner, Chairman, 1980, and Culture Methods for the Detection Charles H. Domermuth, H. Graham Pur- of Animal Salmonellosis and Arizonosis, chase, James E. Williams.) 1980, pp. 40–42, Iowa State University Press, Ames, Iowa Creative Printing Company, Inc., Endwell, 50010, 1976. NY 13760.

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microscope are recommended for obser- as noted in paragraph (e)(4) of this sec- vation of the colonies as they are rare- tion, to prevent the precipitation of ly more than 0.2–0.3 mm in diameter. proteins. (c) Isolates must be serotyped. (4) Mycoplasma Broth Base, dextrose, (1) Isolates may be shipped in MBM phenol red, and cysteine hydrochloride with ice packs if shipment will be in are added to deionized distilled water transit less than 2–3 days. Longer ship- first if autoclave sterilization is used. 16 ments require freezing of the MBM Thallium acetate and then the remain- with dry ice, or shipping MAM slants ing components are added aseptically at room temperature. Isolates must after cooling the autoclaved media to have indications of growth before ship- 45 °C or less. ment is made. (5) Use sterile deionized distilled (2) Isolates may be stored in MBM at water to reconstitute penicillin. ¥20 °C for 2–3 weeks, or they may be (6) Sterile serum should be inac- stored at ¥68 °C for several years. tivated by heating at 56 °C for 30 min- (d) Alternate method of culture: An utes. Swine serum may be used for M. overlay enrichment culture for fas- tidious and sensitive mycoplasma, es- gallisepticum, M. synoviae, M. pecially for M. meleagridis should be in- gallinarum, and M. meleagridis isolation; cluded. however, horse serum is usually rec- (1) Pour 2–3 ml of MAM into a test ommended for M. meleagridis isolation. tube and tilt the tube until a slant (ap- (7) Phenol red should be prepared as a proximately 45 deg;) is obtained. Other 1 percent solution. containers are acceptable. (8) NAD (beta nicotinamide adenine (2) Overlay the slant with sufficient dinucleotide or coenzyme I) should be MBM, so that the media (including prepared as a 1 percent solution. 17 inoculum) covers the agar slope. (9) Cysteine hydrochloride, prepared (3) Inoculate the culture as indicated as a 1 percent solution, is used to rein paragraph (b) of this section. duce the NAD for M. synoviae growth. (4) Incubate and examine the overlay (10) A purified agar product such as as indicated in paragraph (b) of this Nobel (Special agar) is used in the section. MAM. 18 (e) Preparation of media compo- (11) Adjust the pH with NaOH. nents: 13 (12) Sterilization may be accom- (1) Deionized distilled water suitable plished by two methods: for cell culture fluids should be used. (i) Filtration sterilization through a (2) All glassware should be carefully 0.20 micron filter is the recommended washed with a nonresidue detergent method. Aseptic techniques must be such as Alcojet and rinsed three times utilized. in tap water and twice in deionized dis- ° tilled water. 14 (ii) Autoclave sterilization at 120 C, (3) Thallium acetate in a 10 percent 15 pounds pressure (103 kPa), for 15 solution is added to an approximate minutes may be used, if preferred, final concentration of 1:4000; however, when following the procedure described highly contaminated specimens may in paragraph (e)(4) of this section. require a final concentration of (13) Phenol red, dextrose, and NAD 1:2000. 15 Thallium acetate is added to may be omitted when culturing for M. deionized distilled water first, except meleagridis and M. gallinarum.

13 Trade names are used in these procedures 16 Mycoplasma Broth Base may be obtained solely for the purpose of providing specific from: (a) Product #M 33600, Gibco information. Mention of a trade name does Diagnostics, 2801 Industrial Drive, Madison, not constitute a guarantee or warranty of WI 53711. (b) Product #3900–3212, Scott Lab- the product by the U.S. Department of Agri- oratories, Inc., 8 Westchester Plaza, culture or an endorsement over other prod- Elmsford, NY 10523. ucts not mentioned. 17 NAD Grade III may be obtained from: 14 Alcojet is available from: Alconox, Inc., Sigma Chemical Company, P.O. Box 14508, New York, NY 10003. St. Louis, MO 63178. 15 Thallium acetate may be obtained from 18 Noble Agar may be obtained from: Difco Fischer Scientific Company. Laboratories, Box 1058–A, Detroit, MI 48201.

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(14) When culturing for M. meleagridis of growth, colony size, and numbers of from contaminated samples include 100 colonies which develop. 19 units/ml of Polymyxin B in MBM. [47 FR 21995, May 20, 1982, as amended at 57 (f) Mycoplasma Broth Medium (Frey) FR 57343, Dec. 4, 1992; 59 FR 12805, Mar. 18, is prepared as follows: To 850–880 ml of 1994; 61 FR 11524, Mar. 21, 1996; 65 FR 8019, deionized distilled water; Feb. 17, 2000; 74 FR 14718, Apr. 1, 2009; 76 FR Add: 15797, Mar. 22, 2011] Thallium acetate (ml)—2.5 (1:4000) § 147.16 Procedure for the evaluation Potentially contaminated samples of mycoplasma reactors by in vivo (ml)—5.0 (1:2000) bio-assay (enrichment). Mycoplasma Broth Base (g)—22.5 This procedure has been shown to be Aqueous penicillin (units)—500,000 sensitive enough to detect less than 100 Sterile serum (ml)—120 to 150.0 mycoplasma organisms under proper Phenol red plus (ml)—2.5 conditions. 20 Proper conditions are de- NAD (ml)—12.5 fined in this section. Cysteine hydrochloride (ml)—12.5 (a) Obtain chickens or turkeys (test Dextrose (g)—1.0–1.5 birds) which are at least 3 weeks of age Adjust pH to 7.8 and are free of M. gallisepticum, M. Filter sterilize synoviae, and M. meleagridis and trans- ° port them in a manner to prevent their (1) Broth may be stored at 4 C for at being contaminated by any infectious ¥ ° least 2 weeks or at 40 C for longer avian disease. periods. (1) Maintain test birds in an area (g) Mycoplasma Agar Medium (Frey) that has been effectively cleaned and is prepared as follows: To 850–880 ml of disinfected. deionized distilled water; (2) The area should be isolated from Add: other birds or animals. Mycoplasma Broth Base (g)—22.5 (3) Personnel caring for the test birds Adjust pH to 7.8 should take the necessary precautions Purified agar (g)—12.0 (see § 147.26(b)) to prevent the mechan- Autoclave and cool in 45 °C water bath ical transfer of infectious avian dis- Thallium acetate (ml)—2.0; (1:4000) eases from other sources. Sterile serum at 45 °C (ml)—150.0 (b) Test birds to be used for inocula- Aqueous penicillin (units)—400,000 tion with contaminated tissues should NAD (ml)—12.5 be serologically negative by the serum plate agglutination test. Cysteine hydrochloride (ml)—12.5 (1) Inoculated test birds should be (1) Rotate flask gently and pour isolated from non-inoculated control about 15 ml of media into each petri birds for the length of any experiment. dish. (c) Aseptically obtain tracheal, turbi- (2) Stack petri dishes only 2–3 high in nate, and sinus mucosa, lung and sinus a 37 °C incubator up to 2 hours to remove excess moisture. 19 ‘‘Laboratory Procedures and Medium For (3) Wrap inverted plates in sealed The Isolation Of Mycoplasma From Clinical bundles and store at 4 °C for not more Materials.’’ Laboratory Diagnosis of Myco- than 15 days. plasma in Food Animals, Proceedings of Nine- (h) New component or media batches teenth Annual Meeting, The American Asso- ciation of Veterinary Laboratory Diagnosti- should be monitored to compensate for cians, 1976, pp. 106–115, AAVLD, 6101 Mineral changes in formulation due to alter- Point Road, Madison, WI 53705. ations of purity, concentration, prepa- 20 Research results are described in the fol- ration, etc. A known series of titra- lowing two publications: (a) Bigland, C. H. tions from a single culture should be and A. J. DaMassa, ‘‘A Bio-Assay for Myco- made on both new and old media. The plasma Gallisepticum.’’ In: United States Livestock Sanitary Association Proceedings, media should be compared on the basis 67th, 1963, pp. 541–549. (b) McMartin, D. A., ‘‘Mycoplasma Gallisepticum in the Res- piratory Tract of the Fowl.’’ In: The Veteri- nary Record, September 23, 1967, pp. 317–320.

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exudates, cervical, thoracic, and ab- bition poultry, and game bird flocks dominal airsac tissues (including le- and poults from turkey flocks for sal- sions), and portions of oviduct and monella. synovial fluid from at least four sus- (a) For cull chicks, from 25 randomly pect, donor birds. In a sterile device, selected 1- to 5-day-old chicks that blend the tissues completely in four have not been placed in a brooding times their volume of Mycoplasma house, prepare 5 organ pools, 5 yolk Broth Medium (Frey), (see § 147.15(f)). pools, and 5 intestinal tissue pools as Suspensions may be made from tissue follows. For poults, from a sample of 10 pools. Inoculate test birds within 30 poults that died within 10 days after minutes for preparation of suspensions. hatching, prepare organ pools, yolk (1) Inoculate at least four test birds pools, and intestinal pools as follows: for each suspension pool via the ab- (1) Organ pool: From each of five dominal air sac and infraorbital sinus, chicks or two poults, composite and with up to 1⁄2 ml of inoculum per site. mince 1- to 2-gram samples of heart, (2) Test birds should be bled every 7 lung, liver, and spleen tissues. Include days for 35 days to identify sero-con- the proximal wall of the bursa of verters. Fabricius for chicks only. (3) At 35 days, test birds should be (2) Yolk pool: From each of five sacrificed and bacteriologic isolation chicks or two poults, composite and and identification of mycoplasma at- mince 1- to 2-gram samples of the tempted (see § 147.15). Note especially unabsorbed yolk sac or, if the yolk sac the sites of inoculation for typical is essentially absent, the entire yolk gross or microscopic mycoplasma le- stalk remnant. sions. (3) Intestinal pool: From each of five (d) Donor birds are considered in- chicks or two poults, composite and fected when: mince approximately 0.5 cm2 sections (1) Test birds have serum plate anti- of the crop wall and 5-mm-long sec- bodies for the mycoplasma for which tions of the duodenum, cecum, and the donor birds were tested, regardless ileocecal junction. of HI test results, and control birds stay serologically negative; or (b) Transfer each pool to tetrathio- (2) Mycoplasma organisms are iso- nate selective enrichment broth (Hajna lated from the test birds and serotyped or Mueller-Kauffmann) at a ratio of 1 positive for the mycoplasma for which part tissue pool to 10 parts broth. the donor birds were tested, and con- (c) For cull chicks, repeat the steps trol birds stay serologically and culin paragraphs (a) and (b) of this section turally negative. for each 5-chick group until all 25 (e) Laboratory findings may be chicks have been examined, producing verified by direct cultures of material a total of 15 pools (5 organ, 5 yolk, and from sick birds or by inoculating 5 intestinal). For poults, repeat the seronegative birds from the suspect steps in paragraphs (a) and (b) of this flock and comparing serological find- section for each two-poult group until ings with those from the test birds. all the poults in the sample have been examined. [47 FR 21996, May 20, 1982, as amended at 57 (d) Culture the tetrathionate pools as FR 57343, Dec. 4, 1992; 59 FR 12805, Mar. 18, 1994; 61 FR 11524, Mar. 21, 1996; 65 FR 8019, outlined for selective enrichment in il- Feb. 17, 2000; 74 FR 14718, Apr. 1, 2009; 76 FR lustration 2 of § 147.11. Incubate the 15797, Mar. 22, 2011] organ and yolk pools for 24 hours at 37 °C and the intestinal pools at 41.5 °C. § 147.17 Laboratory procedure rec- Plate as described in illustration 2 of ommended for the bacteriological § 147.11 and examine after both 24 and 48 examination of cull chicks and hours of incubation. Confirm suspect poults for salmonella. colonies as described. Further culture The laboratory procedure described all salmonella-negative tetrathionate in this section is recommended for the broths by delayed secondary enrich- bacteriological examination of cull ment procedures described for environ- chicks from egg-type and meat-type mental, organ, and intestinal samples chicken flocks and waterfowl, exhi- in illustration 2 of § 147.11. A colony lift

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assay may also be utilized as a supple- (e) Replacement breeders shall be ment to TSI and LI agar picks of sus- housed at the proper density consistent pect colonies. with the type of building and locality and which will allow the litter to be [61 FR 11525, Mar. 21, 1996, as amended at 72 maintained in a dry condition. Fre- FR 1425, Jan. 12, 2007] quent stirring of the litter may be necessary to reduce excess moisture and Subpart C—Sanitation Procedures prevent surface accumulation of droppings. Slat or wire floors should be con- § 147.21 Flock sanitation. structed so as to permit free passage of To aid in the maintenance of healthy droppings and to prevent the birds flocks, the following procedures should from coming in contact with the drop- be practiced: pings. Nesting areas should be kept (a) Baby poultry should be started in clean and, where appropriate, filled a clean brooder house and maintained with clean nesting material. in constant isolation from older birds (f) When an outbreak of disease oc- and other animals. Personnel that are curs in a flock, dead or sick birds in contact with older birds and other should be taken, by private carrier, to animals should take precautions, in- a diagnostic laboratory for complete cluding disinfection of footwear and examination. All Salmonella cultures change of outer clothing, to prevent isolated should be typed serologically, the introduction of infection through and complete records maintained by droppings that may adhere to the the laboratory as to types recovered shoes, clothing, or hands. (See from each flock within an area. § 147.24(a).) Records on isolations and serological (b) Range used for growing young types should be made available to Offi- stock should not have been used for cial State Agencies or other animal poultry the preceding year. Where disease control regulatory agencies in broods of different ages must be kept the respective States for followup of on the same farm, there should be com- foci of infection. Such information is plete depopulation of brooder houses necessary for the development of an ef- and other premises following infection fective Salmonella control program. of such premises by any contagious dis- (g) Introduction of started or mature ease. birds should be avoided to reduce the (c) Poultry houses should be screened possible hazard of introducing infec- and proofed against free-flying birds. tious diseases. If birds are to be intro- An active rodent eradication campaign duced, the health status of both the is an essential part of the general sani- flock and introduced birds should be tation program. The area adjacent to evaluated. the poultry house should be kept free (h) In rearing broiler or replacement from accumulated manure, rubbish, stock, a sound and adequate immuniza- and unnecessary equipment. Dogs, tion program should be adopted. Since cats, sheep, cattle, horses, and swine different geographic areas may require should never have access to poultry op- certain specific recommendations, the erations. Visitors should not be admit- program recommended by the State ex- ted to poultry areas, and authorized periment station or other State agen- personnel should take the necessary cies should be followed. precautions to prevent the introduc- (i) Feed, pelleted by heat process, tion of disease. should be fed to all age groups. Proper (d) Poultry houses and equipment feed pelleting procedures can destroy should be thoroughly cleaned and dis- many disease producing organisms con- infected prior to use for a new lot of taminating feedstuffs. birds. (See § 147.24(a).) Feed and water (Approved by the Office of Management and containers should be situated where Budget under control number 0579–0007) they cannot be contaminated by drop- [36 FR 23121, Dec. 3, 1971, as amended at 41 pings and should be frequently cleaned FR 14257, Apr. 2, 1976; 41 FR 48726, Nov. 5, and disinfected. Dropping boards or 1976. Redesignated at 44 FR 61586, Oct. 26, pits should be constructed so birds do 1979, and amended at 50 FR 19900, May 13, not have access to the droppings. 1985; 59 FR 12805, Mar. 18, 1994]

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§ 147.22 Hatching egg sanitation. egg tray and hatching basket washing. Traffic and airflow patterns in the Hatching eggs should be collected hatchery should be from clean areas to from the nests at frequent intervals dirty areas (i.e., from egg room to and, to aid in the prevention of con- chick/poult processing rooms) and tamination with disease-causing orga- should avoid tracking from dirty areas nisms, the following practices should back into clean areas. be observed: (c) The hatchery rooms, and tables, (a) Cleaned and disinfected con- racks, and other equipment in them tainers, such as egg flats, should be should be thoroughly cleaned and dis- used in collecting the nest eggs for infected frequently. All hatchery hatching. Egg handlers should thor- wastes and offal should be burned or oughly wash their hands with soap and otherwise properly disposed of, and the water prior to and after egg collection. containers used to remove such mate- Clean outer garments should be worn. rials should be cleaned and sanitized (b) Dirty eggs should not be used for after each use. hatching purposes and should be col- (d) The hatching compartments of in- lected in a separate container from the cubators, including the hatching trays, nest eggs. Slightly soiled nest eggs should be thoroughly cleaned and dis- may be gently dry cleaned by hand. infected after each hatch. (c) Hatching eggs should be stored in (e) Only clean eggs should be used for a designated egg room under conditions hatching purposes. that will minimize egg sweating. The (f) Only new or cleaned and dis- egg room walls, ceiling, floor, door, infected egg cases should be used for heater, and humidifier should be transportation of hatching eggs. Soiled cleaned and disinfected after every egg egg case fillers should be destroyed. pickup. Cleaning and disinfection pro- (g) Day-old chicks, poults, or other cedures should be as outlined in § 147.24. newly hatched poultry should be dis- (d) The egg processing area should be tributed in clean, new boxes and new cleaned and disinfected daily. chick papers. All crates and vehicles (e) Effective rodent and insect con- used for transporting birds should be trol programs should be implemented. cleaned and disinfected after each use. (f) The egg processing building or area should be designed, located, and [67 FR 8474, Feb. 25, 2002] constructed of such materials as to as- § 147.24 Cleaning and disinfecting. sure that proper egg sanitation procedures can be carried out, and that the The following procedures are rec- building itself can be easily, effec- ommended: tively, and routinely sanitized. (a) In the poultry houses: (g) All vehicles used for transporting (1) Remove all live ‘‘escaped’’ and eggs or chicks/poults should be cleaned dead birds from the building. Blow dust and disinfected after use. Cleaning and from equipment and other exposed sur- disinfection procedures should be as faces. Empty the residual feed from the outlined in § 147.24. feed system and feed pans and remove it from the building. Disassemble feed- [67 FR 8474, Feb. 25, 2002] ing equipment and dump and scrape as needed to remove any and all feed cake § 147.23 Hatchery sanitation. and residue. Clean up spilled feed An effective program for the preven- around the tank and clean out the tion and control of Salmonella and tank. Rinse down and wash out the in- other infections should include the fol- side of the feed tank to decontaminate lowing measures: the surfaces and allow to dry. (a) An effective hatchery sanitation (2) Remove all litter and droppings to program should be designed and imple- an isolated area where there is no op- mented. portunity for dissemination of any in- (b) The hatchery building should be fectious disease organisms that may be arranged so that separate rooms are present. Housing where poultry in- provided for each of the four oper- fected with a mycoplasmal disease ations: Egg receiving, incubation and were kept should remain closed for 7 hatching, chick/poult processing, and days before removal of the litter.

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(3) Wash down the entire inside sur- incubator to normal operating tem- faces of the building and all the in- perature. stalled equipment such as curtains, (3) The hatcher should be fumigated ventilation ducts and openings, fans, (see § 147.25) or otherwise disinfected fan housings and shutters, feeding prior to the transfer of the eggs. equipment, watering equipment, etc. (4) If the same machine is used for in- Use high pressure and high volume cubating and hatching, the entire ma- water spray (for example 200 pounds chine should be cleaned after each per square inch and 10 gallons per hatch. A vacuum cleaner should be minute or more) to soak into and reused to remove dust and down from the move the dirt to decontaminate the egg trays; then the entire machine building. Scrub the walls, floors, and should be vacuumed, mopped, and fu- equipment with a hot soapy water solu- migated (see § 147.25) or otherwise sani- tion. Rinse to remove soap. tized. (4) Spray with a disinfectant which is (c) The egg and chick/poult delivery registered by the Environmental Pro- truck drivers and helpers should use tection Agency as germicidal, fungi- the following good biosecurity prac- cidal, pseudomonocidal, and tuberculocidal, in accordance with the tices while picking up eggs or deliv- specifications for use, as shown on the ering chicks/poults: label of such disinfectant. (1) Spray truck tires thoroughly with (b) In the hatchers and hatchery disinfectant before leaving the main rooms: road and entering the farm driveway. (1) Use cleaning agents and sanitizers (2) Put on sturdy, disposable plastic that are registered by the U.S. Envi- boots or clean rubber boots before get- ronmental Protection Agency as ger- ting out of the truck cab. Put on a micidal, fungicidal, pseudomonocidal, clean smock or coveralls and a hairnet and tuberculocidal. Use manufacturer’s before entering the poultry house. recommended dilution. Remove loose (3) After loading eggs or unloading organic debris by sweeping, scraping, chicks/poults, remove the dirty smock/ vacuuming, brushing, or scrubbing, or coveralls and place into plastic garbage by hosing surface with high pressure bag before loading in the truck. Be sure water (for example 200 pounds per to keep clean coveralls separate from square inch and 10 gallons per minute dirty ones. or more). Remove trays and all con- (4) Reenter the cab of the truck and trols and fans for separate cleaning. remove boots before placing feet onto Use hot water (minimum water tem- floorboards. Remove hairnet and leave perature of 140 °F) for cleaning hatch- with disposable boots on farm. ing trays and chick separator equip- (5) Sanitize hands using appropriate ment. Thoroughly wet the ceiling, hand sanitizer. walls, and floors with a stream of (6) Return to the hatchery or go to water, then scrub with a hard bristle the next farm and repeat the process. brush. Use a cleaner/sanitizer that can penetrate protein and fatty deposits. [36 FR 23121, Dec. 3, 1971. Redesignated at 44 Allow the chemical to cling to treated FR 61586, Oct. 26, 1979, and amended at 49 FR surfaces at least 10 minutes before rins- 19806, May 10, 1984; 57 FR 57343, Dec. 4, 1992; ing off. Manually scrub any remaining 63 FR 3, Jan. 2, 1998; 67 FR 8474, Feb. 25, 2002] deposits of organic material until they § 147.25 Fumigation. are removed. Rinse until there is no longer any deposit on the walls, par- Fumigation may be used for sani- ticularly near the fan opening, and tizing eggs and hatchery equipment or apply disinfectant. Use a clean and rooms as a part of a sanitation pro- sanitized squeegee to remove excess gram. APHIS disclaims any liability in water, working down from ceilings to the use of formaldehyde for failure on walls to floors and being careful not to the part of the user to adhere to the recontaminate cleaned areas. Occupational Safety and Health Ad- (2) Replace the cleaned fans and con- ministration (OSHA) standards for trols. Replace the trays, preferably formaldehyde fumigation, published in still wet from cleaning, and bring the the Dec. 4, 1987, FEDERAL REGISTER (52

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FR 46168, Docket Nos. H–225, 225A, and (11) Keep accurate records of death 225B). losses; (12) Seek services of veterinary diag- [36 FR 23121, Dec. 3, 1971, as amended at 41 FR 14257, Apr. 2, 1976. Redesignated at 44 FR nostician if unaccountable mortality 61586, Oct. 26, 1979, and amended at 49 FR or signs of disease occur; 19807, May 10, 1984; 54 FR 23958, June 5, 1989; (13) Adopt and maintain a clean-egg 57 FR 57343, Dec. 4, 1992; 67 FR 8475, Feb. 25, program. 2002] (14) Use only crates and vehicles that have been cleaned and disinfected in § 147.26 Procedures for establishing accordance with the provisions of isolation and maintaining sanita- § 147.24(a) to haul live poultry to and tion and good management prac- from the premises. tices for the control of Salmonella and Mycoplasma infections. (Approved by the Office of Management and (a) The following procedures are re- Budget under control number 0579–0007) quired for participation under the U.S. [36 FR 23121, Dec. 3, 1971, as amended at 40 Sanitation Monitored, U.S. M. FR 1504, Jan. 8, 1975; 41 FR 48727, Nov. 5, 1976. Gallisepticum Clean, U.S. M. Synoviae Redesignated at 44 FR 61586, Oct. 26, 1979; 47 Clean, U.S. S. Enteritidis Monitored, FR 746, Jan. 7, 1982; 47 FR 21996, May 20, 1982; and U.S. S. Enteritidis Clean classifica- 48 FR 57473, Dec. 30, 1983; 61 FR 11525, Mar. 21, 1996; 67 FR 8475, Feb. 25, 2002] tions: (1) Allow no visitors except under § 147.27 Procedures recommended to controlled conditions to minimize the prevent the spread of disease by ar- introduction of Salmonella and Myco- tificial insemination of turkeys. plasma. Such conditions must be ap- (a) The vehicle transporting the in- proved by the Official State Agency semination crew should be left as far as and the Service; practical from the turkey pens. (2) Maintain breeder flocks on farms (b) The personnel of the insemination free from market birds and other do- crew should observe personal cleanli- mesticated fowl. Follow proper isola- ness, including the following sanitary tion procedures as approved by the Of- procedures: ficial State Agency; (1) Outer clothing should be changed (3) Dispose of all dead birds by locally between visits to different premises so approved methods. that clean clothing is worn upon enter- (b) Recommended procedures: ing each premises. The used apparel (1) Avoid the introduction of Sal- should be kept separate until monella, Mycoplasma gallisepticum, or laundered. This also applies to gloves Mycoplasma synoviae infected poultry; worn while handling turkeys; (2) Prevent indirect transmission (2) Boots or footwear should be from outside sources through contami- cleaned and disinfected between visits nated equipment, footwear, clothing, to different premises; vehicles, or other mechanical means; (3) Disposable caps should be pro- (3) Provide adequate isolation of vided and discarded after use on each breeder flocks to avoid airborne trans- premises. mission from infected flocks; (c) The use of individual straw or (4) Minimize contact of breeder similar technique is highly rec- flocks with free-flying birds; ommended. Insemination equipment (5) Establish a rodent control pro- which is to be reused should be cleaned gram to keep the rodent population and disinfected before reusing. Equip- and other pests under control; ment used for the convenience of the (6) Tailor vaccination programs to workers should not be moved from needs of farm and area; premises to premises. (7) Clean and disinfect equipment (d) No obviously diseased flock after each use; should be inseminated. If evidence of (8) Provide clean footwear and pro- active disease is noted after insemina- vide an adequate security program; tion is begun, operations should be (9) Clean and disinfect houses before stopped and the hatchery notified. introducing a new flock; (e) Care should be taken during the (10) Use clean, dry litter free of mold; collection of semen to prevent fecal

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contamination. If fecal material is PBS or 1 mL of broth culture by a non- present, it should be removed before phenolic procedure. Centrifuge samples the semen is collected. Likewise, care at 14,000 × g for 5 to 10 minutes. Decant should be taken not to introduce fecal supernatant and wash the pellet with 1 material into the oviduct of the hen. mL of PBS. Centrifuge as above and re- suspend the pellet in 25–50 μl of 0.1 per- Subpart D—Molecular cent DEP (Diethyl Pyrocarbonate; Examination Procedures Sigma) water. Boil at 120 °C for 10 minutes followed by 10 minutes incubation at 4 °C. Centrifuge as above and trans- SOURCE: 72 FR 1425, Jan. 12, 2007, unless fer the supernatant DNA to a nuclease- otherwise noted. free tube. Estimate the DNA con- § 147.30 Laboratory procedure rec- centration and purity by ommended for the polymerase spectrophotometric reading at 260 nm chain reaction (PCR) test for Myco- and 280 nm. plasma gallisepticum and M. (b) Primer selection. (1) M. synoviae. gallisepticum. The primer for M. (a) DNA isolation. Isolate DNA from 1 gallisepticum should consist of the fol- mL of eluate from tracheal swabs in lowing sequences:

(2) M. synoviae. The primer for M. synoviae should consist of the following sequences:

(c) Polymerase chain reaction. (1) Treat (ii) 18 μl water, 25 μl PCR mix each sample (100 to 2000 ng/5 μl) with (Promega), 1 μl Reverse primer (50 μM), one of the following 45 μl PCR cock- 1 μl Forward primer (50 μM). tails: (2) Perform DNA amplification in a (i) 5 μl 10x PCR buffer, 1 μl dNTP (10 Perkin-Elmer 9600 thermocycler or in a μ μ mM), 1 l of Reverse primer (50 M), 1 Hybaid PCR Express thermocycler. 21 μ μ μ l of Forward primer (50 M), 4 l MgCl2 The optimized PCR program is as fol- μ μ (25 mM), 1 l taq-polymerase (5 U), 32 l lows: DEP water.

Temperature (°C) Duration Cycles

94 ...... 30 seconds ...... 30–40. 55 ...... 30 seconds ...... 30–40.

21 Trade names are used in these procedures the product by the U.S. Department of Agri- solely for the purpose of providing specific culture or an endorsement over other prod- information. Mention of a trade name does ucts not mentioned. not constitute a guarantee or warranty of

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Temperature (°C) Duration Cycles

72 ...... 1 minute ...... 30–40. 72 ...... 5 minutes ...... 1 (final extension).

(d) Electrophoresis. Mix PCR products PCR 2X mix (Qiagen, Valencia, CA),22 (5 to 10 μl) with 2 μl loading buffer primers to a final concentration of 0.5 (Sigma) and electrophorese on a 2 per- μmolar, and probe to a final concentra- cent agarose gel containing 0.5 μg/mL tion of 0.1 μmolar, 1μl of HK–UNG ethidium bromide in TAE buffer (40 Thermolabile Uracil N-glycosylase mM tris; 2 mM EDTA; pH 8.0 with gla- (Epicentre, Madison, WI), 2 μl of water, cial acetic acid) for 30 minutes at 80 V. and 5 μl of template. The reaction can M. gallisepticum (185 bp) and M. synoviae be performed in a SmartCycler (Ceph- (214 bp) amplicons can be visualized eid, Sunnyvale, CA) or other equivalent under an ultraviolet transilluminator validated platform procedure for real- ° along with the PCR marker (50 to 2000 time thermocycler at 50 C for 2 minutes; 95 °C for 15 minutes with optics bp; Sigma). OFF; and 40 cycles of 94 °C for 15 sec- [72 FR 1425, Jan. 12, 2007, as amended at 74 onds followed by 60 °C for 60 seconds FR 14718, Apr. 1, 2009; 76 FR 15797, Mar. 22, with optics ON. 2011] (d) Determination of positive. For each MGLP ReTi assay reaction, the thresh- § 147.31 Laboratory procedures rec- old cycle number (CT value) was deter- ommended for the real-time polym- mined to be the PCR cycle number at erase chain reaction test for Myco- which the fluorescence of the reaction plasma gallisepticum (MGLP ReTi). exceeded 30 units of fluorescence. For (a) DNA extraction. Use Qiagen Qiamp all samples tested, any MGLP reaction Mini Kit for DNA extraction or equiva- that has a recorded CT value was con- lent validated technique/procedure. sidered positive, while any MGLP reac- This kit utilizes the following methods: tion that had no recorded CT value was 100 μl of swab suspension incubates considered negative. with 10 μl of proteinase K and 400 μl of (e) Controls. Proper controls should lysis buffer at 56 °C for 10 minutes. Fol- be used when conducting the MGLP lowing incubation, 100 μl of 100 percent ReTi assay as an official test of the ethanol is added to lysate. Wash and Plan. Positive, quantitative, extrac- centrifuge following extraction kit rection, and internal controls are com- ommendations. mercially available from GTCAllison, (b) Primer selection. A forward primer LLC, Mocksville, NC. mglpU26 (5′-CTA GAG GGT TGG ACA [74 FR 14718, Apr. 1, 2009, as amended at 76 GTT ATG–3′) located at nucleotide po- FR 15797, Mar. 22, 2011] sitions 765,566 to 765,586 of the M. gallisepticum R strain genome sequence; Subpart E—Procedure for Chang- a reverse primer mglp164 (5′-GCT GCA ing National Poultry Improve- CTA AAT GAT ACG TCA AA–3′) lo- ment Plan cated at nucleotide positions 765,448 to 765,470 of the M. gallisepticum R strain § 147.41 Definitions. genome sequence; and a Taqman dual- Except where the context otherwise labeled probe mglpprobe (5′-FAM–CAG requires, for the purposes of this sub- TCA TTA ACA ACT TAC CAC CAG part the following terms shall be con- AAT CTG–BHQ1–3′) located at nucleo- strued, respectively, to mean: tide positions 765,491 to 765,520 of the M. gallisepticum R strain genome should 22 Trade names are used in these procedures be used to amplify a 139-bp fragment of solely for the purpose of providing specific the lp gene. information. Mention of a trade name does (c) MGLP ReTi. Primers and probe not constitute a guarantee or warranty of μ the product by the U.S. Department of Agri- should be utilized in a 25 l reaction culture or an endorsement over other prod- containing 12.5 μl of Quantitect Probe ucts not mentioned.

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Department. The U.S. Department of paragraph (b) of this section, from each Agriculture. of the following regions: Egg type chickens. Chickens bred for (1) North Atlantic: Maine, New the primary purpose of producing eggs Hampshire, Vermont, Massachusetts, for human consumption. Rhode Island, Connecticut, New York, Exhibition Poultry. Domesticated fowl New Jersey, and Pennsylvania. which are bred for the combined pur- (2) East North Central: Ohio, Indiana, poses of meat or egg production and Illinois, Michigan, and Wisconsin. competitive showing. (3) West North Central: Minnesota, Game birds. Domesticated fowl, such Iowa, Missouri, North Dakota, South as pheasants, partridge, quail, grouse, Dakota, Nebraska, and Kansas. and guineas, but not doves and pigeons. (4) South Atlantic: Delaware, Dis- Meat type chickens. Chickens bred for trict of Columbia, Maryland, Virginia, the primary purpose of producing West Virginia, North Carolina, South meat. Carolina, Georgia, Florida, and Puerto Plan Conference. A meeting convened Rico. for the purpose of recommending (5) South Central: Kentucky, Ten- changes in the provisions of the Plan. nessee, Alabama, Mississippi, Arkan- Plan or NPIP. The National Poultry sas, Louisiana, Oklahoma, and Texas. Improvement Plan. (6) Western: Montana, Idaho, Wyo- Service. The Animal and Plant Health ming, Colorado, New Mexico, Arizona, Inspection Service, Veterinary Serv- Utah, Nevada, Washington, Oregon, ices, of the Department. California, Alaska, and Hawaii. State. Any State, the District of Co- (b) The regional committee members lumbia, or Puerto Rico. and their alternates will be elected by the official delegates of their respec- Waterfowl. Domesticated fowl that normally swim, such as ducks and tive regions, and the member-at-large geese. will be elected by all official delegates. There must be at least two nominees [36 FR 23121, Dec. 3, 1971, as amended at 38 for each position, the voting will be by FR 3038, Feb. 1, 1973. Redesignated at 44 FR secret ballot, and the results will be re- 61586, Oct. 26, 1979; 59 FR 12805, Mar. 18, 1994] corded. At least one nominee from each region must be from an underrep- § 147.42 General. resented group (minorities, women, or Changes in this subchapter shall be persons with disabilities). The process made in accordance with the procedure for soliciting nominations for regional described in this subpart: Provided, committee members will include, but That the Department reserves the not be limited to: Advertisements in at right to make changes in this sub- least two industry journals, such as the chapter without observance of such newsletters of the American Associa- procedure when such action is deemed tion of Avian Pathologists, the Na- necessary in the public interest. tional Chicken Council, the United Egg Producers, and the National Turkey § 147.43 General Conference Com- Federation; a FEDERAL REGISTER an- mittee. nouncement; and special inquiries for (a) The General Conference Com- nominations from universities or col- mittee Chairperson and the Vice Chair- leges with minority/disability enroll- person shall be elected by the members ments and faculty members in poultry of the General Conference Committee. science or veterinary science. A representative of the Animal and (c) Three regional members shall be Plant Health Inspection Service will elected at each Plan Conference. All serve as Executive Secretary and will members shall serve for a period of 4 provide the necessary staff support for years, subject to the continuation of the General Conference Committee. the Committee by the Secretary of Ag- The General Conference Committee riculture, and may not succeed them- shall consist of one member-at-large selves: Provided, That an alternate who is a participant in the National member who assumed a Committee Poultry Improvement Plan and one member vacancy following mid-term member to be elected, as provided in would be eligible for re-election to a

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full term. When there is a vacancy for sitated by unforeseen conditions when the member-at-large position, the Gen- postponement until the next Plan Con- eral Conference Committee shall make ference would seriously impair the op- an interim appointment and the ap- eration of the program. Such rec- pointee shall serve until the next Plan ommendations shall remain in effect Conference at which time an election only until confirmed or rejected by the will be held. If a vacancy occurs due to next Plan Conference, or until re- both a regional member and alternate scinded by the committee. being unable to serve, the vacant posi- (6) Serve as an official advisory com- tion will be filled by an election at the mittee for the study of problems relat- earliest regularly scheduled national ing to poultry health and as the need or regional Plan Conference, where arises, to make specific recommenda- members of the affected region have tions to the Secretary of Agriculture assembled. concerning ways in which the Depart- (d) The duties and functions of the ment may assist the industry in solv- General Conference Committee shall be ing these problems. as follows: (7) Serve as a direct liaison between (1) Advise and make recommenda- the NPIP and the United States Ani- tions to the Department on the rel- mal Health Association. ative importance of maintaining, at all (8) Advise and make recommenda- times, adequate departmental funding tions to the Department regarding for the NPIP to enable the Senior Coor- NPIP involvement or representation at dinator and staff to fully administer poultry industry functions and activi- the provisions of the Plan. ties as deemed necessary or advisable (2) Advise and make yearly rec- for the purposes of the NPIP. ommendations to the Department with [36 FR 23121, Dec. 3, 1971, as amended at 40 respect to the NPIP budget well in ad- FR 1505, Jan. 8, 1975. Redesignated at 44 FR vance of the start of the budgetary 61586, Oct. 26, 1979, and amended at 45 FR process. 10316, Feb. 15, 1980; 47 FR 21996, May 20, 1982; (3) Assist the Department in plan- 50 FR 19900, May 13, 1985; 59 FR 12805, Mar. 18, 1994; 61 FR 11525, Mar. 21, 1996; 65 FR 8023, ning, organizing, and conducting the Feb. 17, 2000; 67 FR 8475, Feb. 25, 2002; 74 FR biennial National Poultry Improve- 14718, Apr. 1, 2009] ment Plan Conference. (4) Consider each proposal submitted § 147.44 Submitting, compiling, and as provided in § 147.44 and make rec- distributing proposed changes. ommendations to subpart Committees (a) Changes in this subchapter may and the Conference. Meet jointly with be proposed by any participant, Official the NPIP Technical Committee and State Agency, the Department, or consider the technical aspects and ac- other interested person or industry or- curacy of each proposal. Recommend ganization. whether new proposals (i.e., proposals (b) Except as provided in § 147.43(d)(2), that have not been submitted as pro- proposed changes shall be submitted in vided in § 147.44) should be considered writing so as to reach the Service not by the delegates to the Plan Con- later than 150 days prior to the opening ference. date of the Plan Conference, and par- (5) During the interim between Plan ticipants in the Plan shall submit their Conferences, represent the cooperating proposed changes through their Official States in: State Agency. (i) Advising the Department with re- (c) The name of the proponent shall spect to administrative procedures and be indicated on each proposed change interpretations of the Plan provisions when submitted. Each proposal should as contained in 9 CFR. be accompanied by a brief supporting (ii) Assisting the Department in eval- statement. uating comments received from inter- (d) The Service will notify all persons ested persons concerning proposed on the NPIP mailing lists concerning amendments to the Plan provisions. the dates and general procedure of the (iii) Recommending to the Secretary conference. Hatchery and dealer par- of Agriculture any changes in the pro- ticipants will be reminded of their visions of the Plan as may be neces- privilege to submit proposed changes

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and to request copies of all the pub- (9) Commercial upland game birds lished proposed changes. and waterfowl and raised-for-release (e) The proposed changes, together upland game birds and waterfowl. with the names of the proponents and (b) Each official delegate shall be ap- supporting statements, will be com- pointed a voting member in one of the piled by the Service and issued in proc- committees specified in paragraph (a) essed form. When two or more similar of this section. changes are submitted, the Service will (c) Since several of the proposals endeavor to unify them into one pro- may be interrelated, the committees posal acceptable to each proponent. shall consider them as they may relate Copies will be distributed to officials of to others, and feel free to discuss re- the Official State Agencies cooperating lated proposals with other committees. in the NPIP. Additional copies will be (d) The committees shall make rec- made available for meeting individual ommendations to the conference as a requests. whole concerning each proposal. The committee report shall show any pro- [36 FR 23121, Dec. 3, 1971. Redesignated at 44 posed change in wording and the record FR 61586, Oct. 26, 1979, and amended at 49 FR 19807, May 10, 1984] of the vote on each proposal, and suggest an effective date for each proposal § 147.45 Official delegates. recommended for adoption. The individual committee reports shall be sub- Each cooperating State shall be enti- mitted to the chairman of the con- tled to one official delegate for each of ference, who will combine them into the programs prescribed in parts 145 one report showing, in numerical se- and 146 of this chapter in which it has quence, the committee recommenda- one or more participants at the time of tions on each proposal. the Conference. The official delegates (e) The committee meetings shall be shall be elected by a representative open to any interested person. Advo- group of participating industry mem- cates for or against any proposal bers and be certified by the Official should feel free to appear before the ap- State Agency. It is recommended but propriate committee and present their not required that the official delegates views. be Plan participants. Each official delegate shall endeavor to obtain, prior to [36 FR 23121, Dec. 3, 1971, as amended at 41 the Conference, the recommendations FR 48727, Nov. 5, 1976. Redesignated at 44 FR of industry members of his State with 61586, Oct. 26, 1979, as amended at 65 FR 8023, respect to each proposed change. Feb. 17, 2000; 71 FR 56333, Sept. 26, 2006; 74 FR 14718, Apr. 1, 2009] [41 FR 48727, Nov. 5, 1976. Redesignated at 44 FR 61586, Oct. 26, 1979, and amended at 45 FR § 147.47 Conference consideration of 10317, Feb. 15, 1980; 65 FR 8023, Feb. 17, 2000; proposed changes. 71 FR 56333, Sept. 26, 2006; 74 FR 14718, Apr. (a) The chairman of the conference 1, 2009; 76 FR 15797, Mar. 22, 2011] shall be a representative of the Depart- § 147.46 Committee consideration of ment. proposed changes. (b) At the time designated for voting on proposed changes by the official del- (a) The following committees shall be egates, the chairman of the General established to give preliminary consid- Conference Committee and the four eration to the proposed changes falling committee chairmen shall sit at the in their respective fields: speaker’s table and assist the chairman (1) Egg-type breeding chickens. of the conference. (2) Meat-type breeding chickens. (c) Each committee chairman shall (3) Breeding turkeys. present the proposals which his com- (4) Breeding waterfowl, exhibition mittee approves or recommends for poultry, and game birds. adoption as follows: ‘‘Mr. Chairman. (5) Breeding ostriches, emus, rheas, The committee for Egg-type chickens and cassowaries. recommends the adoption of Proposal (6) Egg-type commercial chickens. No. lll, for the following reasons (7) Meat-type commercial chickens. (stating the reasons): I move the adop- (8) Meat-type commercial turkeys. tion of Proposal No. lll.’’ A second

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will then be called for. If the rec- (j) Proposed changes shall be adopted ommendation is seconded, discussion by a majority vote of the official dele- and a formal vote will follow. gates present and voting. (d) Each committee chairman shall (k) The conference shall be open to present the proposals which his com- any interested person. mittee does not approve as follows: [36 FR 23121, Dec. 3, 1971, as amended at 41 ‘‘Mr. Chairman. The Committee for FR 48727, Nov. 5, 1976. Redesignated at 44 FR Egg-type chickens does not approve 61586, Oct. 26, 1979] Proposal No. lll.’’ The chairman will then ask if any official delegate § 147.48 Approval of conference rec- wishes to move for the adoption of the ommendations by the Department. proposal. If moved and seconded, the Proposals adopted by the official del- proposal is subject to discussion and egates will be recommended to the De- voted. If there is no motion for ap- partment for incorporation into the proval, or if moved but not seconded, provisions of the NPIP. The Depart- there can be no discussion or vote. ment reserves the right to approve or (e) Discussion on any motion must be disapprove the recommendations of the withheld until the motion has been conference as an integral part of its properly seconded, except that the del- sponsorship of the National Poultry egate making the motion is privileged, Improvement Plan. if he desires, to give reasons for his motion at the time of making it. To gain Subpart F—Authorized the floor for a motion or for discussion Laboratories and Approved Tests on a motion, the official delegate in the case of a motion, or anyone in case SOURCE: 74 FR 14718, Apr. 1, 2009, unless of discussion on a motion, shall rise, otherwise noted. address the chair, give his name and State, and be recognized by the chair § 147.51 Authorized laboratory min- before proceeding further. While it is imum requirements. proper to accept motions only from of- These minimum requirements are in- ficial delegates and to limit voting tended to be the basis on which an au- only to such delegates, it is, however, thorized laboratory of the Plan can be equally proper to accept discussion evaluated to ensure that official Plan from anyone interested. To conserve assays are performed and reported as time, discussion should be pointed and described in this part A satisfactory limited to the pertinent features of the evaluation will result in the laboratory motion. being recognized by the NPIP office of (f) Proposals that have not been sub- the Service as an authorized laboratory qualified to perform the assays pro- mitted in accordance with § 147.44 will vided for in this part. be considered by the conference only (a) Check-test proficiency. The labora- with the unanimous consent of the tory must use a regularly scheduled General Conference Committee. Any check test for each assay that it per- such proposals must be referred to the forms. appropriate committee for consider- (b) Trained technicians. The testing ation before being presented for action procedures at the laboratory must be by the conference. run or overseen by a laboratory techni- (g) Voting will be by States, and each cian who has attended and satisfac- official delegate, as determined by torily completed Service-approved lab- § 147.45, will be allowed one vote on oratory workshops for Plan-specific each proposal pertaining to the pro- diseases within the past 3 years. gram prescribed by the subpart which (c) Laboratory protocol. Official Plan he represents. assays must be performed and reported (h) A roll call of States for a recorded as described in this part. vote will be used when requested by a (d) State site visit. The Official State delegate or at the discretion of the Agency will conduct a site visit and chairman. recordkeeping audit annually. (i) All motions on proposed changes (e) Service review. Authorized labora- shall be for adoption. tories will be reviewed by the Service

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(NPIP staff) every 3 years. The Serv- nificance of the effect(s) can be evalu- ice’s review may include, but will not ated. necessarily be limited to, checking (3) The kit will be provided to the co- records, laboratory protocol, check- operating laboratories in its final form test proficiency, technician training, and include the instructions for use. and peer review. The cooperating laboratories must per- (f) Reporting. (1) A memorandum of form the assay exactly as stated in the understanding or other means shall be supplied instructions. Each laboratory used to establish testing and reporting must test a panel of at least 25 known criteria to the Official State Agency, positive clinical samples supplied by including criteria that provide for re- the manufacturer of the test kit. In ad- porting H5 and H7 low pathogenic dition, each laboratory will be asked to avian influenza directly to the Service. test 50 known negative clinical samples (2) Salmonella pullorum and Myco- obtained from several sources, to pro- plasma Plan disease reactors must be vide a representative sampling of the reported to the Official State Agency general population. The identity of the within 48 hours. samples must be coded so that the co- (g) Verification. Random samples may operating laboratories are blinded to also be required to be submitted for identity and classification. Each sam- verification as specified by the Official ple must be provided in duplicate or State Agency. triplicate, so that error and repeat- ability data may be generated. § 147.52 Approved tests. (4) Cooperating laboratories will sub- (a) The procedures for the bacterio- mit to the kit manufacturer all raw logical examination of poultry and data regarding the assay response. poultry environments described in this Each sample tested will be reported as part are approved tests for use in the positive or negative, and the official NPIP. In addition, all tests that use NPIP procedure used to classify the veterinary biologics (e.g., antiserum sample must be submitted in addition and other products of biological origin) to the assay response value. that are licensed or produced by the (5) The findings of the cooperating Service and used as described in this laboratories will be evaluated by the part are approved for use in the NPIP. NPIP technical committee, and the (b) Diagnostic test kits that are not technical committee will make a rec- licensed by the Service (e.g., bacterio- ommendation regarding whether to ap- logical culturing kits) may be approved prove the test kit to the General Con- through the following procedure: ference Committee. If the technical (1) The sensitivity of the kit will be committee recommends approval, the estimated in at least three authorized final approval will be granted in ac- laboratories selected by the Service by cordance with the procedures described testing known positive samples, as de- in §§ 147.46 and 147.47. termined by the official NPIP proce- (c) The following diagnostic test kits dures found in Subparts A, B, C, and D that are not licensed by the Service of this part. If certain conditions or (e.g., bacteriological culturing kits) interfering substances are known to af- are approved for use in the NPIP: fect the performance of the kit, appro- (1) Rapid Chek ©;Select priate samples will be included so that TMSalmonella Test Kit, Strategic the magnitude and significance of the Diagnostics, Inc., Newark, DE 19713. effect(s) can be evaluated. (2) ADIAFOOD Rapid Pathogen De- (2) The specificity of the kit will be tection System for Salmonella spp., estimated in at least three authorized AES Chemunex Canada. Laval, QC laboratories selected by the Service by (Canada) H7L4S3. testing known negative samples, as determined by the official NPIP proce- (3) DuPont Qualicon BAX Polym- dures found in this part. If certain con- erase Chain Reaction (PCR)-based ditions or interfering substances are assay for Salmonella, DuPont Qualicon, known to affect the performance of the Wilmington, DE 19810. kit, appropriate samples will be in- [74 FR 14718, Apr. 1, 2009, as amended at 76 cluded so that the magnitude and sig- FR 15798, Mar. 22, 2011]

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PART 149—VOLUNTARY TRICHINAE swine remains from a pork production CERTIFICATION PROGRAM site. Animal movement record. A written Sec. record of the movement of swine into 149.0 Purpose and scope. or from a pork production site. 149.1 Definitions. APHIS Administrator. The Adminis- 149.2 Program participation. trator, Animal and Plant Health In- 149.3 Site audit. spection Service, or any person author- 149.4 Spot audit. ized to act for the APHIS Adminis- 149.5 Offsite identification and segregation trator. of certified swine. APHIS representative. Any individual 149.6 Slaughter facilities. employed by or acting as an agent on 149.7 Recordkeeping at site. behalf of the Animal and Plant Health 149.8 Program fees and charges. Inspection Service who is authorized 149.9 Pilot program sites. by the APHIS Administrator to per- AUTHORITY: 7 U.S.C. 1622 and 8301–8317; 21 form the services required by this part. U.S.C. 136a; 7 CFR 2.22, 2.80, and 371.4. Approved laboratory. A non-Federal SOURCE: 73 FR 60479, Oct. 10, 2008, unless laboratory approved by the Agricul- otherwise noted. tural Marketing Service and recognized by the APHIS Administrator or § 149.0 Purpose and scope. FSIS Administrator for performing The Trichinae Certification Program validated tests to determine the pres- described in this part is intended to en- ence of trichinae infection in reference hance the ability of swine producers, as to the Trichinae Certification Pro- well as slaughter facilities and other gram. persons that handle or process swine Audit. An inspection process, as pro- from pork production sites that have vided in this part, that generates a been certified under the program, to written record documenting a pork export fresh pork and pork products to production site’s adherence to the re- foreign markets. quired good production practices. Auditor. A qualified accredited veteri- § 149.1 Definitions. narian (QAV) or a qualified veterinary Accredited veterinarian. A veteri- medical officer (QVMO) who is trained narian approved by the APHIS Admin- and authorized by APHIS to perform istrator in accordance with part 161 of auditing activities under the Trichinae this chapter to perform functions spec- Certification Program. . A designation ified in subchapters B, C, D, and G of Certification (certified) given by the APHIS Administrator to a this chapter. pork production site for compliance Agricultural Marketing Service (AMS). with good production practices and The Agricultural Marketing Service of other program requirements of the the United States Department of Agri- Trichinae Certification Program as culture. provided in this part. The Adminis- AMS Administrator. Certified pork. Pork products origi- trator, Agricultural Marketing Serv- nating from certified swine from a cer- ice, or any person authorized to act for tified production site with identity of the AMS Administrator. such animals or carcasses maintained AMS representative. Any individual throughout receiving, handling, and employed by or acting as an agent on processing. 1 behalf of the Agricultural Marketing Certified production site. A pork pro- Service who is authorized by the AMS duction site that has attained a pro- Administrator to perform services re- gram status of Stage II or higher, quired by this part. based on adherence to good production Animal and Plant Health Inspection practices and other program require- Service (APHIS). The Animal and Plant ments as provided in this part. Health Inspection Service of the United States Department of Agriculture. 1 The labeling of all certified pork or pork Animal disposal plan. A written docu- products leaving a slaughter or processing ment that describes methods for the re- facility must comply with 9 CFR 317.4 and all moval and disposal of dead swine or other applicable FSIS labeling regulations.

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Certified swine. Swine produced under Laboratory approval audit. An audit the Trichinae Certification Program on performed by AMS representatives to a certified production site. determine if a laboratory meets min- Confinement unit. A structure on a imum requirements for approval, as es- pork production site in which swine are tablished by AMS, for performing vali- housed and fed that is totally roofed dated tests under this part. and that is constructed in such a man- National Trichinae Certified Herd. All ner as to prevent swine from being ex- swine raised on certified production posed to free-flying birds and other sites in the United States. wildlife, and from coming into contact Person. Any individual, corporation, with the carrion of free-flying birds or company, association, firm, partner- other wildlife. ship, society, joint stock company, or Decertification (decertified). Removal other legal entity. of the certified status of a production Pest control operator. A person trained site by the APHIS Administrator when and State-licensed in the control of it has been determined that the cri- pests and vermin (particularly ro- teria of the Trichinae Certification dents). Program are not being met or main- Pooled sample digestion method (diges- tained. tion method). A method of testing swine Enzyme-linked immunosorbent assay for trichinae infection by identifying (ELISA). A method of testing swine for the presence of Trichinella spp. from a the presence of trichinae infection by sample of the animal’s muscle tissue. looking for antibodies to Trichinella spp. in the sera, plasma, whole blood, Pork production site (site). A geo- tissue fluid, or meat juice of swine. graphically definable area that includes pork production facilities and EPA. The United States Environ- mental Protection Agency. ancillary structures under common ownership or management systems and Feed mill quality assurance affidavit. A written statement signed by the feed the surrounding space within a 100-foot mill representative and the producer perimeter of the confinement unit. that documents the quality and safety Positive test result. Outcome of a vali- of feed or feed ingredients delivered dated test indicating the presence of from the feed mill to the pork produc- Trichinella spp. tion site. Premises Identification Number (PIN). Food Safety and Inspection Service A number assigned to a pork produc- (FSIS). The Food Safety and Inspection tion site by the APHIS Administrator. Service of the United States Depart- Process-verification testing. Testing of ment of Agriculture. a statistically valid sample of swine FSIS Administrator. The Adminis- belonging to the National Trichinae trator, Food Safety and Inspection Certified Herd at the time of slaughter Service, or any person authorized to using a validated test to verify that act for the Administrator. the adherence to good manufacturing FSIS program employee. Any indi- practices and good production prac- vidual employed by or acting as an tices is resulting in the absence of agent on behalf of the Food Safety and Trichinella spp. infection in swine from Inspection Service who is authorized that herd. by the FSIS Administrator to perform Producer. An individual or entity the services required by this part. that owns or controls the production or Good manufacturing practices. Feed management of swine. manufacturing practices that reduce, Qualified accredited veterinarian eliminate, or avoid the risk of exposure (QAV). An accredited veterinarian who of swine to Trichinella spp. has been granted a program certifi- Good production practices. Pork pro- cation by the APHIS Administrator duction management practices that re- pursuant to § 161.5 of this chapter based duce, eliminate, or avoid the risk of ex- on completion of an APHIS-approved posure of swine to Trichinella spp. training program in good production Harborage. Any object, debris, clut- practices in swine management, and ter, or area that could serve as shelter who is authorized by the APHIS Ad- or refuge for rodents or wildlife. ministrator to perform site audits and

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other specified program services re- Sterile zone. An open area imme- quired by this part. 2 diately adjacent to and surrounding Qualified veterinary medical officer the confinement unit that serves as (QVMO). A VMO of the State or Fed- both a buffer and detection zone for ro- eral Government who is trained in good dent and wildlife activity. production practices and is authorized Temporary withdrawal. The voluntary by the APHIS Administrator to per- withdrawal of a certified production form site audits, spot audits, and other site from the Trichinae Certification specified program services required by Program at the request of the producer this part. for a period not to exceed 180 days. Rodent control logbook. A written Trichinae. A generic term that refers record that documents a rodent control to Trichinella spp. program for a pork production site. Trichinae Certification Program (pro- Site audit. An audit, performed by a gram). A voluntary pre-harvest pork QAV or a QVMO, to determine the safety program in which APHIS cer- trichinae risk factor status of a pork tifies pork production sites that follow production site based on the site’s ad- all of the required good production herence to all of the required good pro- practices that reduce, eliminate, or duction practices that reduce, elimi- avoid the risk of exposure of swine nate, or avoid the risk of exposure of from their sites to Trichinella spp. swine to Trichinella spp. Trichinella spp. Parasitic nematodes Slaughter facility. A slaughtering es- (roundworms) capable of infecting tablishment operating under the Fed- many warm-blooded carnivores and eral Meat Inspection Act (21 U.S.C. 601 omnivores, including swine. et seq.) or a State meat inspection act USDA. The United States Depart- that receives certified swine under the ment of Agriculture. Trichinae Certification Program. Validated test. An analytical method Slaughter facility representative. Any licensed by APHIS or accepted by AMS individual employed by, or acting as an for the diagnosis of Trichinella spp. in agent on behalf of, a slaughter facility swine. who is authorized by the slaughter fa- Veterinary medical officer (VMO). A cility to perform the specified program veterinarian employed by the State or services required by this part. Federal Government who is authorized Spot audit. An audit of a certified to perform official animal health ac- pork production site performed by a tivities on their behalf. QVMO to ensure program integrity and [73 FR 60479, Oct. 10, 2008, as amended at 74 consistency. FR 65010, Dec. 9, 2009] Stage I enrolled. Preliminary program status of a pork production site at- § 149.2 Program participation. tained when the APHIS Administrator A producer’s initial enrollment and approves the outcome of an initial site continued participation in the audit. Trichinae Certification Program re- Stage II certified. Program status at- quires that the producer adhere to all tained upon APHIS approval of a site of the good production practices, as audit of a Stage I enrolled site. confirmed by periodic site audits, and Stage III certified. Program status at- comply with other recordkeeping and tained upon APHIS approval of a site program requirements provided in this audit of a Stage II certified site and part. Pork production sites accepted maintained upon APHIS approval of into the program by APHIS will par- subsequent site audits for renewal of ticipate under one of the following Stage III certified status. three program stages: (a) Stage I enrolled status. (1) Stage I 2 Accredited veterinarians interested in ob- enrolled status signifies that the site taining program certification related to the has met good production practices and Trichinae Certification Program should con- other recordkeeping and program re- tact APHIS’ National Trichinae Coordinator at (515) 284–4122 or write to: USDA, APHIS, quirements provided in this part. Veterinary Services, Trichinae Certification (2) Swine from a Stage I enrolled site Program, 210 Walnut St., Room 891, Des cannot be identified as products from a Moines, IA 50309. certified production site.

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(3) A Stage I enrolled site must com- as provided in paragraph (e)(1) of this plete a site audit for Stage II certified section. During the time a site is decer- status in accordance with § 149.3(d). tified, swine from that site cannot be Under § 149.3(d), the site audit must be identified as certified products from a performed no sooner than 150 days from certified production site. the date the site was awarded Stage I (c) Stage III certified status. (1) Stage enrolled status, and must be com- III certified status signifies that the pleted, with the audit form and pay- site is adhering to all of the required ment submitted to APHIS, no later good production practices and other than 210 days from the date the site recordkeeping and program require- was awarded Stage I enrolled status. ments provided in this part. (4) A Stage I enrolled site that is (2) An APHIS-issued certificate or found not to be adhering to one or letter indicating the site’s status as a more good production practices as a re- Stage III certified site must be filed at sult of a site audit or spot audit, or the site and be readily available for in- that fails to follow the prescribed time- spection. table for completing a site audit and (3) Swine from a Stage III certified submitting the completed audit form site may be identified as certified prod- and payment for consideration as a ucts from a certified production site. Stage II certified site, will be subject (4) In order to maintain Stage III cer- to a review by APHIS to consider the tified status, sites must arrange for nature of the infraction(s), and may site audits to renew such status ac- lose its status as a Stage I enrolled site. cording to the timetable set forth in (b) Stage II certified status. (1) Stage II § 149.3(f). Under § 149.3(f), the site audit certified status signifies that the site must be performed no sooner than 14 is adhering to all of the required good months from the date the site was production practices and other record- awarded Stage III certified status or keeping and program requirements pro- the date that status was last renewed, vided in this part. and must be completed, with the audit (2) An APHIS-issued certificate or form and payment submitted to letter indicating the site’s status as a APHIS, no later than 16 months from Stage II certified site must be filed at either the date the site was awarded the site and be readily available for in- Stage III certified status or the date spection. that status was last renewed. (3) Swine from a Stage II certified (5) A Stage III certified site that is site may be identified as certified prod- found not to be adhering to one or ucts from a certified production site. more good production practices as a re- (4) A Stage II certified site must sult of a site audit or spot audit, or complete a site audit for Stage III cer- that fails to follow the prescribed time- tified status in accordance with table for completing a site audit and § 149.3(e). Under § 149.3(e), the site audit submitting the completed audit form must be performed no sooner than 240 and payment to determine its contin- days from the date the site was award- ued participation as a Stage III cer- ed Stage II certified status, and must tified site, will be subject to a review be completed, with the audit form and by APHIS to consider the nature of the payment submitted to APHIS, no later infraction(s) and determine whether to than 300 days from the date the site decertify the site, as provided in para- was awarded Stage II certified status. graph (e)(1) of this section. During the (5) A Stage II certified site that is time a site is decertified, swine from found not to be adhering to one or that site cannot be identified as cer- more good production practices as a re- tified products from a certified produc- sult of a site audit or spot audit, or tion site. that fails to meet the Stage III site (d) Change of ownership—(1) Stage I audit requirements of § 149.3(e) within enrolled site. If there is a change in the prescribed timetable, will be sub- ownership in a Stage I enrolled site, ject to a review by APHIS to consider and the new ownership wishes to re- the nature of the infraction(s) and de- main in the program, then the Stage I termine whether to decertify the site, enrolled site will remain on the same

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timetable as under the previous owner- tified site that is found not to be ad- ship for purposes of completing a site hering to one or more of the good pro- audit for Stage II certified status. No duction practices as a result of a site additional site audit is necessary as a audit, or that fails to follow the pre- result of the change of ownership of the scribed timetable for completing a site site. audit and submitting the completed (2) Stage II or Stage III certified sites. audit form and payment to continue When a change of ownership occurs at participation in the program, will be a Stage II or Stage III certified site, subject to a review by APHIS to con- the previous owner of the site must no- sider the nature of the infraction(s) tify APHIS of this change as soon as and to determine whether the site the transaction is finalized. Within 60 should be decertified. Decertification days of this notification, a site audit will result from infraction(s) that must be performed in order for the site APHIS determines to be substantive, to maintain its certified status. It is prolonged, and/or repeated as a result the new ownership’s responsibility that of this review. a site audit be performed within 60 (ii) During the time a site is decerti- days of this notification, otherwise the fied, swine from such sites cannot be site may be subject to decertification, identified as certified products from a in accordance with paragraph (e)(1) of certified production site. this section. If the site audit is satis- (iii) Once a site is decertified by factory, then the Stage II or Stage III APHIS, a producer wishing to partici- certified site will continue in the pro- pate in the program again must follow gram, initially as a Stage II certified the procedures for requesting a site site. However, a new program anniver- audit for Stage I enrolled status. If a sary date for that site will be estab- decertified site is reenrolled after a lished based on the date the site was successful Stage I site audit, a new pro- audited to continue in the program as gram anniversary date for that site a Stage II certified site, and the pro- will be established based on the date of ducer of the site must arrange for a recertification. If a decertified site is site audit to gain (or regain) Stage III recertified after a successful Stage II certified status based on that new an- site audit, a new program anniversary niversary date and according to the date for that site will be established timetable prescribed in § 149.3(e). If the based on the date of recertification. results of the site audit do not meet program requirements, the Stage II or (2) Temporary withdrawal by producer. Stage III site will be subject to a re- (i) A producer may request that one or view by APHIS to consider the nature more certified production sites be tem- of the infraction(s) and determine porarily withdrawn. A producer’s re- whether to decertify the site, as pro- quest must be made in writing and is vided in paragraph (e)(1) of this sec- subject to the APHIS Administrator’s tion. Once a site is decertified by approval. APHIS, either because the new owner- (ii) Each certified production site can ship fails to arrange for a site audit to be temporarily withdrawn no more be performed within the allotted 60-day than once every 2 years for a period not time period, or because the site is to exceed 180 days. found not to meet program require- (iii) During the time a site is tempo- ments, a producer wishing to partici- rarily withdrawn: pate in the program again must follow (A) Swine from such sites cannot be the procedures for requesting an initial identified as certified products from a audit for Stage I enrolled status. If a certified production site; and decertified site is reenrolled after a (B) The producer must continue to successful Stage I site audit, a new pro- adhere to all good production practices gram anniversary date for that site and other recordkeeping and program will be established based on the date of requirements provided in this part, in- reenrollment. cluding documentation in the animal (e) Site decertification and program movement record of the arrival and de- withdrawal—(1) Decertification by parture of all swine from this site, as APHIS. (i) A Stage II or Stage III cer- well as whether the swine arriving at

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the site are from certified or noncer- will be established based on the date of tified sources, unless a program reenrollment. quirement is specifically waived by the (3) Program withdrawal. (i) If a pro- Administrator. ducer decides to withdraw one or more (iv) If granted a waiver by the Ad- of pork production sites from the pro- ministrator, a producer may receive gram, then it is the producer’s respon- swine 5 weeks of age or older origi- sibility to notify the APHIS Adminis- nating from a noncertified source dur- trator in writing of this intent. When ing the period of withdrawal. this is done, the site will be removed (v) Before being reinstated as a cer- from the program. tified production site, the temporarily (ii) If at a later date the producer re- withdrawn site must pass a site audit quests that a site be reinstated in the to indicate that it is now adhering to program, then the producer must fol- all good production practices (includ- low the procedures for requesting an ing any practices waived by the Admin- initial audit for Stage I enrolled sta- istrator at the beginning of the period tus. If a withdrawn site is reenrolled of withdrawal) as follows: after a successful Stage I site audit, (A) The site audit must be performed then a new program anniversary date while the site is still under temporary for that site will be established based withdrawal status. If swine 5 weeks of on the date of reenrollment. age or older originating from a noncer- (f) Request for review. If there is a con- tified source have been received at the flict as to any material fact relating to site during the time of withdrawal, the results of a site audit, spot audit, then the site audit for reinstatement or other determination affecting a pro- must be performed within 30 days of ducer’s program status or ability to the date the last swine from a noncer- participate in the program, the pro- tified source was removed from the ducer may submit a written request for site, but no later than 180 days from review to the Administrator. The pro- the date the site was granted tem- ducer must include in the request the porary withdrawal status. (B) If the results of the site audit are reasons, including any supporting doc- satisfactory and it is determined that umentation, why the audit result or the site is now adhering to good pro- other determination should be dif- duction practices and other program ferent than the result or determination requirements provided in this part, made by the Administrator. The initial then the withdrawn site will be rein- audit result or other determination stated as a Stage II certified site. The will remain in force pending the com- timetable for performing future site pletion of the Administrator’s review. audits for attaining and renewing The decision by the Administrator Stage III certified status will be based upon reviewing the producer’s written on the date the site was reinstated as a request will be final. Stage II certified site. § 149.3 Site audit. (C) If the results of the site audit are not satisfactory, or, if the period of (a) General. (1) The producer must temporary withdrawal has exceeded 180 contact a QAV or QVMO to request a days, then the site will be subject to a site audit. A list of available QAVs review by APHIS to consider the na- may be obtained by accessing the ture of the infraction(s) and to deter- Trichinae Certification Program Web mine whether to decertify the site, as site on the Internet at http:// provided in paragraph (e)(1) of this sec- www.aphis.usda.gov/vs/trichinae. If a tion. Once the site is decertified by QAV is not available to perform a site APHIS, the producer must follow the audit, the producer must then contact procedures for requesting an initial the APHIS area office to request that a site audit for Stage I enrolled status in QVMO perform the site audit. The site order for the site to be reenrolled in audit is to be arranged at a mutually the program. If a site is decertified by agreed-upon time. APHIS and then reenrolled after a suc- (2) The producer or the producer’s cessful Stage I site audit, a new pro- designated representative will accom- gram anniversary date for that site pany the auditor during the site audit.

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(3) During the site audit, the auditor APHIS will provide the producer with will record whether the producer is ad- written notification of the audit re- hering to all of the required good pro- sults. Pork production sites that meet duction practices at the site, as pro- all good production practices as provided in paragraph (b) of this section, vided in paragraph (b) of this section, in order to reduce, eliminate, or avoid as well as other program requirements the risk of exposure of swine to provided in this part, will be issued Trichinella spp. program status at the appropriate pro- (4) The auditor will use APHIS-ap- gram stage. proved audit forms in performing the (9) If the site audit shows that the site audit. After the auditor has com- site does not substantively meet all pleted all sections of the audit form, good production practices or other pro- the producer or the producer’s des- gram requirements, APHIS will provide ignated representative must sign the the producer with written notification audit form attesting to the accuracy of that includes documentation of the de- the information obtained during the ficiencies that prevented the site from site audit and to evidence his or her in- being conferred program status. tent to continue adhering to the good (b) Good production practices. In a site production practices and other pro- audit, the auditor will determine gram requirements, as provided in this whether all of the required good pro- part. The auditor also must sign the duction practices are being carried out audit form at this time. at the site to reduce, eliminate, or (5) If a QVMO performs the site audit, avoid the risk of exposure of swine to then the producer will pay the QVMO Trichinella spp. as follows: at the time the site audit is performed (1) The movement of all non-breeding in accordance with the rate and other swine 5 weeks of age or older into or conditions set by the QVMO’s govern- from the pork production site must be mental employer. If an APHIS-em- documented in an animal movement ployed QVMO performs the site audit, record, as provided in § 149.7, that en- then the producer will pay APHIS by certified check or U.S. money order for sures that all such swine moved into or this service at a rate determined in ac- from the site can be subsequently cordance with § 149.8. traced back to that site, or to any pre- (6) In addition to the possible cost of vious site (if applicable). the site audit, the producer is also re- (2) All non-breeding swine entering a sponsible for paying a separate pro- site must have originated from another gram fee in an amount specified in certified production site, except that § 149.8 to cover APHIS’ administrative non-breeding swine less than 5 weeks of costs in processing the audit and oper- age may have originated from either a ating the program. This program fee, certified or noncertified production payable to APHIS by certified check or site. The animal movement record U.S. money order, must be remitted to must include the PIN of the certified the auditor at the time each site audit production site from which the swine is performed. originated. If the swine are less than 5 (7) The auditor will submit the com- weeks of age and come from a noncer- pleted audit form, program fee, and tified site, then the animal movement payment for the services of an APHIS- record must provide the name and full employed QVMO, if applicable, to the address of the noncertified site where nearest APHIS area office. If a QAV the swine originated. performs the site audit, the producer (3) Feed or feed ingredients from off- will be responsible for ensuring that site sources that are used at the site the QAV submits the completed audit must meet good manufacturing prac- form and program fee to APHIS in a tices or other quality assurance stand- timely manner. ards recognized by the feed industry. (8) Upon receipt of the completed The adherence to good manufacturing audit form and payment, APHIS will practices or other quality assurance determine the initial enrollment or standards must be documented in a certification status for the site based feed mill quality assurance affidavit, on an evaluation of the site audit. as provided in § 149.7.

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(4) Swine at the site must be housed maintained, and contain fresh bait that and fed in a confinement unit. The con- consists of an EPA-registered finement unit, feed preparation and rodenticide formulation that is applied storage areas, and office areas and con- according to its label. In addition, a necting hallways at the site must be sterile zone must be maintained around inspected regularly and found free of the perimeter of the confinement unit. signs of rodent and wildlife activity The sterile zone must be devoid of any (evidence of rodent activity consists of harborage or feed or water sources that fresh rodent droppings, fresh gnawing could attract rodents or wildlife, but marks, new structural damage, rodent must contain rodent bait stations and/ urine, rodent blood, rodent smear or rodent traps. The sterile zone also marks (body oil), rodent tracks, or re- must be devoid of any vegetation un- cent burrowing or burrow use. Evi- less it is decorative vegetation that is dence of wildlife activity consists of well maintained (i.e., residential height wildlife feces, footprints, fur, or hair grass, flowers, shrubs, or trees). A ster- observed in or near the stored feed or ile zone with decorative vegetation will feed ingredients, dead or live wildlife require increased rodent control meas- observed in or near the stored feed or ures. The producer must provide docu- feed ingredients, or wildlife burrows or mentation of rodent control practices nests observed in or near the stored by maintaining at the site an up-to- feed or feed ingredients). Any movable date rodent control logbook with a site harborage (exterior or interior) on the diagram and other recordkeeping evi- site that is not necessary to the day- dencing implementation of rodent con- to-day operation of the site must be re- trol measures, which can include docu- moved. Harborage that cannot be re- ments provided by a pest control oper- moved or is movable but necessary to ator, as provided in § 149.7. the day-to-day operation of the site (5) Feed or feed ingredients stored at (e.g., equipment) must be checked for the site must be prepared, maintained, signs of rodent or wildlife activity. In and handled in a manner that protects addition, domesticated animals, in- the feed or feed ingredients from pos- cluding pets such as dogs and cats, sible exposure to or contamination by must be excluded from the confinement rodents or wildlife. Any movable har- unit and feed preparation and storage borage in the immediate vicinity of areas at the site. Exterior rodent bait feed production and feed storage areas stations and/or traps must be placed that is not necessary to the day-to-day around the perimeter of the confine- operation of the site must be removed. ment unit. Exterior rodent bait sta- Harborage that cannot be removed or tions and/or traps also must be placed harborage that is movable but nec- around areas of potential rodent entry essary to the day-to-day operation of into the confinement unit (i.e., door- the site (e.g., equipment, etc.) must be ways, vent openings, loading chutes, checked for signs of rodent or wildlife cool cells, etc.). Interior rodent bait activity. Rodent bait stations and/or stations and/or traps must be placed traps must be placed around (and in, if near high-risk rodent zones such as applicable) all feed preparation and entryways, hallways, office areas, storage areas, as well as near any har- swine load-out areas, vents, cool cells, borage in the vicinity that cannot be storage areas, utility rooms, cabinets, removed or that is movable but nec- locker rooms, bathrooms, and break essary to the day-to-day operation of rooms, and systematically maintained. the site. Rodent bait stations must be Interior rodent bait stations and/or intact, systematically maintained, and traps must be placed so that swine will contain fresh bait that consists of an not come in contact with the bait or EPA-registered rodenticide formula- trap. Rodent bait stations and/or traps tion that is applied according to its also must be placed near exterior or in- label. In addition, feed or feed ingredi- terior harborage on the site that can- ents that are stored in paper bags must not be removed or that is movable but be elevated off the floor and be a suffi- necessary to the day-to-day operation cient distance away from the walls to of the site. In all instances, rodent bait allow for inspection, baiting, and/or stations must be intact, systematically trapping. The rodent control logbook,

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as provided in § 149.7, must document will review the completed audit form that adequate rodent control proce- and make a determination within 30 dures have been implemented in the days as to enrollment of the site in the feed production and feed storage areas. program. A pork production site that is (6) Swine must not have access to found to meet all good production prac- dead or live wildlife at the site. Dead or tices and other program requirements live wildlife must not be intentionally in this part will be awarded Stage I en- fed to swine. rolled status. (7) Swine at the site must not be fed (d) Site audit for Stage II certified sta- waste that contains meat. tus. (1) A producer of a Stage I enrolled (8) Procedures must be in place and site must arrange for another site carried out for the prompt removal and audit for Stage II certified status. The proper disposal of dead swine or swine site audit must be performed no sooner remains found in pens in order to than 150 days (i.e., approximately 5 eliminate the opportunity for canni- months) from the date the site was balism, as well as to prevent the at- awarded Stage I enrolled status, and traction of rodents or wildlife. Such must be completed, with the audit procedures must be documented in the form and payment submitted to animal disposal plan, as provided in APHIS, no later than 210 days (i.e., ap- § 149.7. proximately 7 months) from the date (9) General hygiene and sanitation of the site was awarded Stage I enrolled the site must be maintained at all status. times to prevent the attraction of ro- (2) APHIS will review the completed dents and wildlife. Solid non-fecal audit form and make a determination waste (facility refuse) must be placed as to Stage II certified status within 7 in covered receptacles and be regularly days of receipt of the audit form and removed from the site. Spilled feed also payment. must be regularly removed and prop- (i) A Stage I enrolled site that is erly disposed of. found to meet all good production prac- (10) All records required under § 149.7 tices and other program requirements must be kept up to date and readily in this part will be awarded Stage II available for inspection at the site. certified status. (c) Initial site audit for Stage I enrolled (ii) A Stage I enrolled site that is status. (1) Producers interested in par- found, during a site audit, not to be ad- ticipating in the program should re- hering to one or more good production quest and review a pre-audit informa- practices, or that fails to follow the tion packet prepared by APHIS that prescribed timetable for completing a discusses the program, as well as the site audit and submitting the com- steps in preparing for and requesting pleted audit form and payment, will be an initial site audit. 3 When the pro- subject to a review by APHIS to con- ducer and the producer’s herd health sider the nature of the infraction(s), personnel believe that a site meets pro- and may lose its status as a Stage I gram standards, the producer must ar- site. range for an initial site audit, as pro- (e) Site audit for Stage III certified sta- vided in paragraph (a) of this section. tus. (1) A producer of a Stage II en- (2) Upon completion of the initial rolled site must arrange for another site audit and submission of the com- site audit for Stage III certified status. pleted audit form and payment, APHIS The site audit must be performed no sooner than 240 days (i.e., approxi- 3 The pre-audit information packet may be mately 8 months) from the date the obtained from a qualified accredited veteri- site was awarded Stage II certified sta- narian (QAV), State or Federal animal tus, and must be completed, with the health offices, or the National Pork Board, audit form and payment submitted to or by writing to: USDA, APHIS, Veterinary APHIS, no later than 300 days (i.e., ap- Services, Trichinae Certification Program, proximately 10 months) from the date 210 Walnut St., Room 891, Des Moines, IA 50309. A pre-audit packet also may be re- the site was awarded Stage II certified quested electronically through the program status. Web site on the Internet at http:// (2) APHIS will review the completed www.aphis.usda.gov/vs/trichinae. audit form and make a determination

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as to Stage III certified status within § 149.4 Spot audit. 30 days of receipt of the audit form and (a) In addition to regularly scheduled payment. site audits, certified production sites (i) A Stage II certified site that is will be subject to spot audits. found to meet all good production prac- (1) Random spot audit. Certified pro- tices and other program requirements duction sites will be selected by the in this part will be awarded Stage III APHIS Administrator at random for a certified status. spot audit in order to: (ii) A Stage II certified site that is (i) Ensure the integrity of the audit found, during a site audit, not to be ad- process; hering to one or more good production (ii) Verify that the audit process is practices, or that fails to follow the performed in a consistent manner prescribed timetable for completing a across the program; and site audit and submitting the com- (iii) Verify that all required good pleted audit form and payment, will be production practices are being main- subject to a review by APHIS to contained between regularly scheduled site sider the nature of the infraction(s) audits. and determine whether to decertify the (2) Spot audit for cause. A certified site, as provided in § 149.2(e)(1). production site may be subject to a (f) Site audit for renewal of Stage III spot audit to trace back and inves- certified status. (1) A producer seeking tigate any positive test results as a re- to renew a site’s Stage III certified sta- sult of testing of certified swine from tus must arrange for another site that site at the slaughter facility. audit. The site audit must be per- (b) All spot audits will be performed formed no sooner than 14 months from by a QVMO. The producer of the cer- the date the site was awarded Stage III tified production site subject to spot certified status or the date that status audit will not be charged for the spot was last renewed, and must be com- audit. APHIS will provide the producer pleted, with the audit form and pay- with written notification of the results ment submitted to APHIS, no later of the spot audit, including documenta- than 16 months from either the date tion of any deficiencies noted during the site was awarded Stage III certified the audit. If the site is found not to be status or the date the that status was adhering to one or more of the required last renewed. good production practices, then the (2) APHIS will review the completed site will be subject to a review by audit form and make a determination APHIS to consider the nature of the in- as to renewing the site’s Stage III cer- fraction and to determine whether to tified status within 30 days of receipt decertify the site, as provided in of the audit form and payment. § 149.2(e)(1). Unless a spot audit results (i) A Stage III certified site that is in decertification, it does not otherwise found to meet all good production prac- affect the timetables for the comple- tices and other program requirements tion of site audits set forth in para- in this part will have its status as a graphs (e) and (f) of § 149.3. Stage III certified site renewed. § 149.5 Offsite identification and seg- (ii) A Stage III certified site that is regation of certified swine. found, during a site audit, not to be adhering to one or more good production Certified swine moved from a cer- practices, or that fails to follow the tified production site to another location, whether to another certified pro- prescribed timetable for completing a duction site, buying station, collection site audit and submitting the com- point, or slaughter facility, must re- pleted audit form and payment, will be main segregated from noncertified subject to a review by APHIS to con- swine at all times and otherwise main- sider the nature of the infraction(s) tain their identity as certified swine in and determine whether to decertify the such a way that they could be readily site, as provided in § 149.2(e)(1). traced back to the certified production (Approved by the Office of Management and site from which they came. Informa- Budget under control number 0579–0323) tion relating to the identification of

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the certified swine must be docu- ceiving, handling, and processing at mented in the animal movement record the slaughter facility, as well as while maintained by the producer. Failure to awaiting shipment from the facility. properly segregate or maintain the The slaughter facility must maintain identity of certified swine from noncer- the identity of the certified swine or tified swine after leaving the certified pork in a manner that allows the cer- production site will result in the loss of tified swine or pork to be traced back certified status for that shipment of to the certified production site from swine. which it came. A slaughter facility’s failure to properly segregate or main- § 149.6 Slaughter facilities. tain the identity of certified swine and Only slaughter facilities that are edible pork products derived from the under continuous inspection by the certified swine will result in the loss of Food Safety and Inspection Service or certified status for that shipment of under State inspection that the Food swine, as well as the edible pork prod- Safety and Inspection Service has rec- ucts derived from those animals. ognized as equivalent to Federal in- (c) Process-verification testing. A spection may participate in the pro- slaughter facility processing certified gram. To participate in the program, swine is responsible for performing slaughter facilities must follow the rel- process-verification testing to deter- evant provisions of this section relat- mine the Trichinella spp. infection sta- ing to verification, segregation, test- tus of certified swine under its control ing, and recordkeeping. Participating as follows: slaughter facilities that fail to comply (1) Validated tests. Process- with any of the applicable require- verification testing must be performed ments of this section will not be al- by using a validated test. When testing lowed to continue to participate in the involves meat, the sample used for Trichinae Certification Program and such testing must be at least 20 4 the pork or pork products prepared by grams. the facility will not be eligible for a (2) Laboratory approval. Process- certificate of export that identifies the verification testing must be performed product as meeting the standards of in an approved laboratory that has the Trichinae Certification Program. been approved for trichinae testing by the Agricultural Marketing Service (a) Verification of certification. A 5 slaughter facility receiving certified (AMS). The approved laboratory may be maintained and operated by the swine must verify the current certifi- slaughter facility or by another busi- cation status of the pork production ness entity either on the premises of site from which the animals came. The the slaughter facility or at another lo- current certification status may be cation. Laboratory staff performing verified by maintaining dated certifi- process-verification testing must be ac- cation documentation on file or by accredited by AMS to perform this processing the Trichinae Certification gram function. For purposes of quality Program Web site on the Internet at assurance, all laboratory staff ap- http://www.aphis.usda.gov/vs/trichinae. If proved to perform process-verification the slaughter facility is unable to verify a site’s certification status 4 through documentation on file or A copy of the testing methods and check- list for conducting validated tests may be through the program Web site, the obtained by contacting the AMS Trichinae slaughter facility then should contact Analyst and Laboratory Certification Pro- the APHIS area office in the State gram Manager, USDA, AMS, Science and where the site is located. Technology Programs, Technical Services (b) Maintaining identity and segrega- Branch, 1400 Independence Ave., SW., Mail tion of certified swine and pork products. Stop 0272, Washington, DC 20250–0272. The For certified swine to be identified as manager may be contacted by phone at (202) certified pork, certified swine and edi- 690–0621. 5 A copy of the AMS Trichinae Accredited ble pork products derived from cer- Laboratory Program Requirements may be tified swine must remain segregated obtained by contacting the AMS Trichinae from swine and edible pork products Analyst and Laboratory Certification Pro- from noncertified sites throughout re- gram Manager (see footnote 4).

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testing will receive periodic pro- swine from which the sample was ficiency test panels from AMS that taken. must be analyzed correctly in order to (v) FSIS program employees at the maintain their approval status. slaughter facility will review and (3) Testing sample size and frequency. verify that an adequate number of sam- Process-verification testing must meet ples have been collected and that prop- the following minimum requirements er frequency of collection is main- relating to sample size and frequency: tained. FSIS will report this informa- (i) Slaughter facility representatives tion to APHIS. shall determine the yearly processing (vi) AMS representatives will verify capacity of the slaughter facility for through a laboratory approval audit the next 12 months. Officials may use that the laboratory performing proc- the processing capacity over the pre- ess-verification testing is correctly fol- vious 12 months if this period is rep- lowing written procedures relating to resentative of a typical processing the receipt, handling, identification, year. and testing of samples. These written (ii) Slaughter facility representatives procedures must be maintained by the shall estimate the percentage of swine laboratory in a quality assurance man- processed that are likely to come from ual, as provided in paragraph (c)(6) of certified production sites considering this section. In addition, a laboratory all swine expected to be processed at that performs process-verification test- the slaughter facility during the se- ing at a location other than the slaugh- lected 12-month period. Swine that ter facility must include a declaration come from certified production sites of methodology used to test samples are considered the eligible population when providing test results. to be sampled. (vii) The APHIS Administrator may, (iii) Slaughter facility representa- at APHIS’ expense, periodically re- tives shall use the Trichinae Certifi- quest that testing be performed on cation Slaughter Facility Sample Size swine brought to the slaughter facility Determination Table on the Internet at from specific certified production sites. http://www.aphis.usda.gov/vs/trichinae to Requests to test swine from specific find the number of samples to collect certified production sites will count to- from the population of swine from cer- wards the slaughter facility’s total tified production sites. 6 If the eligible monthly testing requirement. population is not listed in that table, (4) Results of testing. (i) The results of the next largest number will be used to all process-verification testing relating determine the number of samples to to certified swine handled at the collect. Select the number of samples slaughter facility must be retained in a to collect from the column on that separate file or notebook as written table that reflects a 99 percent con- records at the slaughter facility and fidence level of detecting a positive must be readily available for inspec- carcass in a population with a preva- tion by FSIS program employees. lence rate of 0.013 percent. The number (ii) FSIS will report to APHIS the re- selected from the table will be the sults of all process-verification testing. total number of samples that slaughter (iii) In the event of a positive test re- facility representatives must collect sult, the slaughter facility representa- and test per year and per month during tive must notify the FSIS program em- the selected 12-month period. ployee designated by the FSIS Admin- (iv) For each sample collected, istrator immediately, who in turn will slaughter facility representatives must report the PIN of the certified produc- maintain the identity of the sample tion site that was the source of the using the PIN of the certified produc- swine from which the sample was tion site that was the source of the taken and the test results of the affected sample to the respective APHIS area office. The following sequence of 6 More information regarding sampling sizes may be obtained by writing to USDA, events must take place following a APHIS, Veterinary Services, Trichinae Cer- positive test result: tification Program, 210 Walnut St., Room (A) If a test sample yields a positive 891, Des Moines, IA 50309. test result based on the digestion

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method, the certified production site from, and all test results relating to that was the source of the swine from process-verification testing. Records which the sample was taken will be de- relating to certified swine must be recertified. tained at the slaughter facility for a (B) If a test sample yields a positive period of at least 3 years following the test result based on an ELISA method processing of such animals. and is confirmed positive by further (ii) All slaughter facilities must have testing using the digestion method, the documented procedures on how cer- certified production site that was the tified swine under its control, and edi- source of the swine from which the ble pork products derived from cer- sample was taken will be decertified. tified swine, will remain segregated (C) If a test sample yields a positive from swine and edible pork products test result based on an ELISA method, from noncertified sites throughout re- but is not confirmed positive by fur- ceiving, handling, and processing at ther testing using the digestion meth- the facility, as well as while awaiting od, then the certified production site shipment from the facility. The slaugh- that was the source of the swine from ter facility must also have documented which the sample was taken will be in- procedures for maintaining the iden- vestigated by APHIS. tity of the certified swine or pork with (1) The investigation may include a respect to the certified production site spot audit of the affected site. Further from which it came. testing of animals or carcasses from (iii) All such records and other docu- the affected site also may be performed mentation required to be maintained as part of the investigation. This inves- by slaughter facilities under this part tigation would determine if the produc- must be readily available for inspection facility has sufficient safeguards tion by FSIS program employees. and is following good production practices. (6) Approved laboratory recordkeeping. (2) While the affected site is under in- Approved laboratories must have writ- vestigation, its program status as a ten procedures that specify standards certified production site will be sus- for sample size, sample handling, sam- pended. While the site is under suspen- ple identification, and sample test sion, the producer must continue to ad- methods used in process-verification here to all of the required good produc- testing. All such written procedures tion practices and other recordkeeping must be maintained in a laboratory and program requirements provided in quality assurance manual specifically this part. During this suspension, swine for this program, or as a separate sec- at the site may be sent to slaughter; tion of an existing laboratory quality however, swine from the suspended site assurance manual, and must be re- cannot be identified as product from a tained at the approved laboratory certified production site. The Adminis- throughout the time the approved lab- trator will determine the program sta- oratory is performing process- tus of the affected site within 30 days verification testing under this proof the initiation of the suspension. gram. All such written procedures re- (3) A finding that risk factors are in- lating to process-verification testing adequately addressed in the site inves- must be readily available for inspec- tigation or the finding of additional tion by FSIS program employees or positive test results based on samples AMS representatives. from animals or carcasses from the af- (7) Slaughter facility overall responsi- fected site will be grounds for APHIS bility for process-verification testing. The decertification of the site. slaughter facility is responsible for ob- (5) Slaughter facility recordkeeping. (i) taining testable samples and for ensur- All slaughter facilities that receive ing that the correct number of testable certified swine must maintain records samples are sent to the testing labora- relating to such animals, including the tory. Once the slaughtering facility re- number of certified swine processed, ceives the test results, it is responsible the source of the certified swine, infor reporting those results in its facil- cluding the PIN of the certified produc- ity trichinae testing record. Moreover, tion site from which the swine came the slaughter facility is responsible for

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ensuring that process-verification test- (v) It must be updated as animal dis- ing is carried out in accordance with posal practices are changed at the site. this part, including the reporting of (vi) It must be signed and dated by test results, regardless of whether it is the producer, as well as the caretaker performed at the slaughter facility or of the site (if the caretaker is a dif- another location, and regardless of ferent person than the producer). whether the testing is performed by (vii) It may be valid for a period no slaughter facility personnel or other longer than 2 years after the date of persons. signature by the producer and (if applicable) the site caretaker. § 149.7 Recordkeeping at site. (2) Animal movement record. The ani- (a) Stage I enrolled sites, Stage II or mal movement record must meet the Stage III certified sites, and any site following minimum requirements: that has been suspended or voluntarily (i) It must be filled out completely decertified must maintain the fol- and properly, accounting for the move- lowing program records: Animal dis- ment of all non-breeding swine into posal plan, animal movement record, and from the pork production site. feed mill quality assurance affidavit (if (ii) In the case of non-breeding swine applicable), and rodent control log- coming into the site, it must include book. All such records must be readily the date and number of arriving ani- available for inspection at the pork mals, as well as the PIN of the certified production site at the time of an audit production site where the animals by a QAV or QVMO, or by other APHIS originated, or alternatively, if the representatives during normal business swine are less than 5 weeks of age and hours. originated from a noncertified site, the (1) Animal disposal plan. The animal name and full address of the noncer- disposal plan must meet the following tified site where the animals origi- minimum requirements: nated. The animal movement record (i) It must provide for the removal of must clearly document that all non- all dead swine or swine remains from breeding swine 5 weeks of age or older swine pens immediately upon detec- arriving at the site originated from an- tion. Inspections for purposes of detect- other certified production site. ing dead animals must occur at least (iii) In the case of non-breeding swine once every 24 hours. leaving the site, it must include the (ii) It must specify how often and at date and number of departing animals, what intervals the swine pens are ob- and their destination. served each day. (iv) It must document the number of (iii) It must provide for the proper dead non-breeding swine that are re- storage of dead swine or swine remains moved from the site, as well as the in accordance with local, State, and number of dead non-breeding swine Federal laws and regulations. If the that are buried or composted at the carcass storage facility or composting site, if swine burial or composting is facility is located on the site, then the permitted in that State or locality. animal disposal plan must provide for a (v) All entries to the animal move- storage or composting facility that ment record must be signed or initialed precludes rodent or wildlife contact and dated by the producer or other site with dead swine or swine remains being caretaker making the entry. stored or composted. (3) Rodent control logbook. The rodent (iv) It must provide for the disposal control logbook, which may include of swine and other mammals by ren- records from a pest control operator, dering, incineration, composting, bur- must meet the following minimum re- ial, or other means, as allowed by and quirements: in accordance with local, State, and (i) It must include a rodent control Federal laws and regulations. For sites diagram for the site indicating the lo- that use rendering services, the animal cation of all rodent bait stations and disposal plan also must include the rodent traps at the site. The diagram name, address, and phone number of must be updated whenever bait sta- the renderer. tions are added, moved, or removed.

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(ii) It must document the number of (b) All such records and other docu- rodent traps set (if applicable), the mentation required under this section number of new rodent bait stations set, must be retained at the pork produc- and how often bait is refreshed. tion site for a period of 2 years. (iii) It must document the disposal (c) All such records and other docu- method for all unused bait that is re- mentation required under this section placed. must be readily available for inspec- (iv) It must document the brand tion at the pork production site at the name and active ingredient of bait, time of an audit by a QAV or QVMO, or which must be EPA-registered and ap- by other APHIS representatives during plied according to its label, as well as normal business hours. the quantity of bait used (number of (Approved by the Office of Management and pounds). Budget under control number 0579–0323) (v) If possible, it should document the number of rodents caught or killed § 149.8 Program fees and charges. and indicate how many were rats. (a) Site audit. If a QVMO performs the (vi) If possible, it should document site audit, then the producer will pay the number of rats sighted monthly. the QVMO at the time the site audit is (vii) All entries to the rodent control performed in accordance with the rate logbook must be signed or initialed, as and other conditions set by the well as dated by the producer or other QVMO’s governmental employer. Fur- site caretaker making the entry. It ther, if the QVMO who performs the must be updated at least monthly. site audit is employed by APHIS, then (4) Feed mill quality assurance affi- the producer will pay APHIS for this davit. The feed mill quality assurance service at the hourly rate listed in affidavit, to be used in conjunction table 1 for each employee required to with feed or feed ingredients delivered perform the service. If the APHIS-em- to the pork production site, must meet ployed QVMO performs the site audit the following minimum requirements: on a Sunday, on a holiday, or at any (i) It must include the name of the time outside the normal tour of duty of producer and the identity of the site, that employee, then the producer will including the PIN if it has been issued, pay APHIS for this service at the hour- and the site address, as well as the ly rate listed in table 2 for each em- name and address of the feed mill and ployee required to perform the service. the name and title of the feed mill rep- Payment to APHIS for the services of resentative. an APHIS-employed QVMO, by cer- (ii) It must provide information that tified check or U.S. money order, must the feed mill is following good manu- be remitted to the QVMO at the time facturing practices, and further speci- the site audit is performed. fy, as evidence of these good manufacturing practices, the following: TABLE 1—RATES FOR SERVICES OF QVMO (A) That the feed mill has a rodent control system that is maintained by Hourly rate: the feed mill itself or by a pest control Per hour ...... $84.00 firm (include name and address of pest Per quarter hour ...... 21.00 control firm). Per service minimum fee ...... 25.00 (B) The frequency with which such rodent control system is maintained TABLE 2—OVERTIME RATES FOR SERVICES OF (i.e., on a weekly basis, etc.); and QVMO (OUTSIDE THE EMPLOYEE’S NORMAL (C) That the feed mill maintains TOUR OF DUTY) records of pest management practices or has records generated by a pest con- Premium hourly rate Monday trol operator, which must be made through Saturday and holidays: available to the producer upon request. Per hour ...... $100.00 (iii) It must be signed by the feed Per quarter hour ...... 25.00 mill representative and by the pro- Premium hourly rate for Sundays: ducer or the producer’s designated rep- Per hour ...... 112.00 resentative, to remain in effect for a Per quarter hour ...... 28.00 period of 2 years.

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(b) Program fee. The producer must § 149.9 Pilot program sites. pay APHIS a program fee at the time Pork production sites participating of each site audit in the amount of $51 in an APHIS-approved trichinae pilot to cover APHIS’ administrative costs program at the time of implementation in processing the audit and operating of the Trichinae Certification Program the program. This program fee, payable on November 10, 2008 will maintain to APHIS by certified check or U.S. their same program status as either a money order, is due at the time of sub- Stage I enrolled, Stage II certified, or mitting the completed site audit form Stage III certified site, as well as their for APHIS evaluation. same program anniversary date for (c) A producer will not be charged for purposes of completing a site audit and the cost of having a spot audit per- submitting the completed audit form formed at the pork production site. and payment.

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PART 151—RECOGNITION OF Animal and Plant Health Inspection BREEDS AND BOOKS OF RECORD Service. The Animal and Plant Health OF PUREBRED ANIMALS Inspection Service of the United States Department of Agriculture (APHIS).

DEFINITIONS Book of record. A printed book or an approved microfilm record sponsored Sec. by a registry association and con- 151.1 Definitions. taining breeding data relative to a CERTIFICATION OF PUREBRED ANIMALS large number of registered purebred 151.2 Issuance of a certificate of pure breed- animals used as a basis for the issuance ing. of pedigree certificates. 151.3 Application for certificate of pure Certificates of pure breeding. A certifi- breeding. cate issued by the Administrator, for 151.4 Pedigree certificate. Bureau of Customs use only, certifying 151.5 Alteration of pedigree certificate. that the animal to which the certifi- 151.6 Statement of owner, agent, or importer as to identity of animals. cate refers is a purebred animal of a 151.7 Examination of animal. recognized breed and duly registered in 151.8 Eligibility of an animal for certifi- a book of record recognized under the cation. regulations in this part for that breed. Department. The United States De- RECOGNITION OF BREEDS AND BOOKS OF partment of Agriculture. RECORD Inspector. An inspector of APHIS or 151.9 Recognized breeds and books of record. of the Bureau of Customs of the United 151.10 Recognition of additional breeds and books of record. States Treasury Department author- 151.11 Form of books of record. ized to perform functions under the regulations in this part. AUTHORITY: 19 U.S.C. 1202; 7 CFR 2.22, 2.80, and 371.4. Pedigree certificate. A document issued by a registry association giving DEFINITIONS the pedigree of an animal and certifying that it is registered in the book § 151.1 Definitions. of record of the association issuing the Words used in this part in the sin- document, and containing all pertinent gular form shall be deemed to import information relating to the registered the plural, and vice versa, as the case animal, such as color and natural and may demand. As used in this part, the artificial markings, a record of the following words, names, or terms shall name and address of the breeder, and have the meanings set forth in this sec- the name and address of each subse- tion, unless otherwise clearly indicated quent owner of the animal. by the context. Port of entry. Any port designated The Act. Item 100.01 in part 1, sched- under § 92.102 for birds, § 92.203 for poul- ule 1, of title I of the Tariff Act of 1930, try, § 92.303 for horses, § 92.403 for as amended (19 U.S.C. 1202, schedule 1, ruminants, or § 92.503 for swine of this part 1, item 100.01). chapter. Administrator. The Administrator, Purebred. A term applicable to ani- Animal and Plant Health Inspection mals which are the progeny of known Service, or any person authorized to and registered ancestors of the same act for the Administrator. recognized breed and for which at least Agent. Custom broker or other person three generations of ancestry can be authorized to act as agent for the im- traced: Provided, however, That in the porter or owner of an animal. case of sheep registered on the basis of Animal. Any purebred animal im- flocks, the term is applicable to ani- ported specially for breeding purposes mals of a recognized breed which origi- except a black, silver, or platinum fox, nate in a flock for which available or any fox which is a mutation or type breeding data, as shown in the registry developed therefrom. association’s records, establish that

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the flock has been in existence at least record listed in said section and on ten years. which there has been entered in accordance with the rules of entry of the reg- [23 FR 10103, Dec. 23, 1958, as amended at 24 FR 2643, Apr. 7, 1959; 26 FR 6072, July 7, 1961; istry association, a complete record of 36 FR 23356, Dec. 9, 1971; 54 FR 34969, 34970, transfers of ownership from the breeder Aug. 23, 1989; 55 FR 31562, Aug. 2, 1990] to and including the United States importer, or a complete record of trans- CERTIFICATION OF PUREBRED ANIMALS fers of ownership from the breeder to and including the person who owns the § 151.2 Issuance of a certificate of pure animal when it is imported into the breeding. United States and the name of the The Administrator will issue a cer- United States importer (for example, a tificate of pure breeding for an animal lessee), shall be furnished by the claimed to be entitled to free entry owner, agent, or importer to the in- under the act provided the require- spector at the time of the examination ments of the regulations in this part of the animal as provided in § 151.7. The are complied with. Such certificate inspector will return the document to will be presented to the owner, agent, the party who submitted it. A verbatim or importer who in turn shall present translation of the description relating it to the collector of customs at the to color and markings shall appear in port where customs entry is made. English in the pedigree certificate for the animal or in a separate certificate [26 FR 6072, July 7, 1961, as amended at 54 FR appended to the pedigree certificate. 34969, Aug. 23, 1989] [26 FR 6072, July 7, 1961] § 151.3 Application for certificate of pure breeding. § 151.5 Alteration of pedigree certifi- An application for a certificate of cate. pure breeding executed by the owner, No pedigree certificate which in the agent, or importer of an animal shall opinion of the Administrator has been be made on ANH Form 17–338 (available substantially altered will be accepted. from the collector of customs) before [23 FR 10104, Dec. 23, 1958, as amended at 54 the animal will be examined as pro- FR 34969, Aug. 23, 1989] vided in § 151.7. Such application shall be made to the inspector at the port of § 151.6 Statement of owner, agent, or entry for all animals: Provided, how- importer as to identity of animals. ever, That the application for a certifi- The owner, agent, or importer who cate of pure breeding for dogs, other applies for a certificate of pure breed- than those regulated under § 92.600 of ing for any animal offered for duty-free this chapter, and cats may be made to entry under this part, shall execute on the inspector either at the port of ANH Form 17–338 a statement that the entry or at any other port where cus- animal so offered for entry is the ani- toms entry is made. An agent shall mal described in the pedigree certifi- show the inspector written authoriza- cate furnished to the inspector as pre- tion from the owner or importer au- scribed in § 151.4. This form shall be thorizing him to act for the owner or presented to the inspector before the importer in connection with the appli- animal and pedigree certificate are ex- cation for a certificate of pure breed- amined as provided in § 151.7. ing. [36 FR 23357, Dec. 9, 1971] (Approved by the Office of Management and Budget under control number 0579–0011) § 151.7 Examination of animal. [26 FR 6072, July 7, 1961, as amended at 36 FR (a) For the purpose of determining 23356, Dec. 9, 1971; 48 FR 57473, Dec. 30, 1983; identity, an examination shall be made 55 FR 31562, Aug. 2, 1990] by an inspector of each animal for which free entry is claimed under the § 151.4 Pedigree certificate. act. All animals shall be examined at A pedigree certificate for an animal the port of entry: Provided, however, of a breed listed in § 151.9 issued by the That dogs, other than those regulated custodian of the appropriate book of under § 92.600 of this chapter, and cats

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may be examined either at the port of registered on inspection without regard entry or at any other port where cus- to purity of breeding. toms entry is made. [23 FR 10104, Dec. 23, 1958] (b) The owner, agent, or importer shall provide adequate assistance and RECOGNITION OF BREEDS AND BOOKS OF facilities for restraining and otherwise RECORD handling the animal and present it in such manner and under such conditions § 151.9 Recognized breeds and books as in the opinion of the inspector will of record. make a proper examination possible. Breeds of animals and books of Otherwise, the examination of the ani- record listed in paragraphs (a) and (b) mal will be refused or postponed by the are hereby recognized. Recognition of inspector until the owner, agent, or im- such breeds and books of record will be porter meets these requirements. continued, however, only if the books (c) A pedigree certificate, as required of record involved are kept by the by § 151.4 shall be presented at the time custodians thereof in a form which is of examination to the inspector mak- reasonably current and the book other- ing the examination in order that prop- wise meets the requirements of this er identification of the animal may be part, in the opinion of the Adminis- made. When upon such examination of trator. When a registry association any animal, the color, markings, or which publishes a book of record that other identifying characteristics do not was recognized in printed form ceases conform with the description given in to publish the book in such form and in the pedigree certificate and the owner, lieu thereof publishes the book in agent, or importer desires to pursue microfilm form, the recognition of the matter further, the inspector shall such book of record will be continued issue ANH Form 17–419 to the owner, only if the book meets the require- agent, or importer, and shall forward ments of this part. A copy of each the pedigree certificate for this animal, printed volume and microfilm record of together with ANH Form 17–419, to the a book of record published after the Washington office of APHIS by cer- book is recognized under this part shall tified mail. A determination will be be sent to APHIS immediately fol- made by such office as to the identity lowing such publication. All books of of the animal in question and the eligi- record sent to the Animal and Plant bility of the animal for certification Health Inspection Service, United under § 151.2. The pedigree certificate States Department of Agriculture, will be returned to the party who sub- shall be submitted through the Veteri- mitted it as soon as such determina- nary Services, Operational Support, tion is made. Removal of an animal 4700 River Road, Unit 33, Riverdale, from the port where examination is Maryland 20737–1231. made prior to presentation of the pedi- (a) Breeds and books of record in coun- gree certificate or other failure to com- tries other than Canada. Books of the ply with the requirements of this para- registry associations listed below are graph shall constitute a waiver of any recognized for the following breeds: further claim to certification under the Provided, That no Belted Galloway cat- regulations in this part. tle, horse of Criolla, Fjordhest (formerly known as Westland), Holstein, [26 FR 6072, July 7, 1961, as amended at 54 FR Shetland Pony or Welsh Pony and Cob 34970, Aug. 23, 1989; 55 FR 31562, Aug. 2, 1990] breed, dog or cat registered in any of the books named shall be certified § 151.8 Eligibility of an animal for cer- under the act as purebred unless a pedi- tification. gree certificate showing three com- To be eligible for certification under plete generations of known and re- the act, an animal must be purebred of corded purebred ancestry of the par- a recognized breed and have been reg- ticular breed involved, issued by the istered in good faith in a book of record appropriate association listed below, is listed in § 151.9 and must not have been submitted for such animal.

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CATTLE

Code Name of breed Book of record By whom published

1101 Aberdeen-Angus ...... Aberdeen-Angus Herd Book ...... Aberdeen-Angus Cattle Society, Hugh R. Neilson, secretary, Pedigree House, 17 Bon-Accord Sq., Aberdeen, Scotland. 1112 ...... do ...... New Zealand Aberdeen-Angus New Zealand Aberdeen-Angus Cattle Breeders’ Associa- Herd Book. tion, Post Office Box 83, Hastings, New Zealand. 116 ...... do ...... Irish Angus Herd Book ...... Irish Angus Cattle Society Ltd., John L. Murphy, Secretary, Agriculture House, Kildare Street, Dublin 2, Ireland. 1102 Africander ...... Africander Cattle Herd Book ...... The Africander Cattle Breeders’ Society, under the supervision and authority of the South African Stud Book As- sociation, E.L. Househam, secretary, 40 Henry St., Bloemfontein, Union of South Africa. 1201 Alderney ...... Herd Book of the Bailiwick of Royal Alderney Agricultural Society (The Alderney Branch Guernsey (Alderney Branch). of the Royal Guernsey A. and H. Society), P.D. Sumner, secretary, The Bungalow, Butes, Alderney, Channel Isles. 1202 Ayrshire ...... Ayrshire Herd Book ...... Ayrshire Cattle Herd Book Society of Great Britain and Ire- land, John Graham, secretary, 1 Racecourse Rd., Ayr, Scotland. 1301 Devon ...... Davy’s Devon Herd Book ...... Devon Cattle Breeders’ Society, Cyril Ernest Berry, secretary, Court House, The Square, Wiveliscombe, Som- erset, England. 1302 Dexter ...... Dexter Herd Book ...... Dexter Cattle Society, T. S. Pick, secretary, Manor Farm, Stubbs Lane, Lower Kingswood, Tadworth, Surrey, Eng- land. 1103 Belted Galloway ...... Belted Galloway Herd Book ...... Belted Galloway Cattle Society, J. Campbel Laing, secretary, Galloway Estate Office, Newton Stewart, Wigtownshire, Scotland. 1104 Galloway ...... Galloway Herd Book ...... Galloway Cattle Society of Great Britain and Ireland, Don- ald M. McQueen, secretary, Roughhills, Dalbeattie, Scot- land. 1113 Gelbvieh ...... Herd Book of the Gelbvieh ...... American Gelbvieh Association, 10900 Dover Street, West- minster, CO 80021. 1203 Guernsey ...... English Guernsey Herd Book ..... English Guernsey Cattle Society, J. W. Barker, secretary, Mappin House, Winsley St., Oxford St., London, W. 1, England. 1204 ...... do ...... Herd Book of the Baliwick of Royal Guernsey Agricultural and Horticultural Society, H. Guernsey (Guernsey Branch). C. Le Page, secretary, States Arcade Balcony, St. Peter Port, Guernsey, Channel Isles. 1105 Hereford ...... Herd Book of Hereford Cattle .... Hereford Herd Book Society, R.J. Bentley, secretary, 3 Offa St., Hereford, England. 1106 Highland ...... Highland Herd Book ...... Highland Cattle Society of Scotland, Donald G. Noble, secretary, 17 York Pl., Perth, Scotland. 1205 Holstein-Friesian ...... Friesch Rundvee-Stamboek ...... Vereeniging: ‘‘Het Friesch Rundvee-Stamboek,’’ Dr. J. M. Dijkstra, secretary, Zuiderplein 2–6, Leeuwarden, The Netherlands. 1206 ...... do ...... Nederlandsch Rundvee- Vereeniging: ‘‘Het Nederlandsche Rundvee-Stamboek,’’ H. Stamboek. W. J. Dekker, Chief Administrator, Stadhouders- plantsoen 24, ’s-Gravenhage, The Netherlands. 1207 Jersey ...... Jersey Herd Book ...... Royal Jersey Agricultural and Horticultural Society, H. G. Shepard, secretary, 3 Mulcaster St., St. Helier, Jersey, Channel Isles. 1208 ...... do ...... Jersey Herd Book of United Jersey Cattle Society of the United Kingdom, Edward Kingdom. Ashby, secretary, 19 Bloomsbury Sq., London, W. C. 1, England. 1303 Kerry ...... British Kerry Cattle Herd Book ... British Kerry Cattle Society, R. O. Hubl, secretary, The Milestone, Stanmore Hill, Stanmore, Middlesex, England. 1304 ...... do ...... Kerry Cattle Herd Book ...... Royal Dublin Society, Horace H. Poole, registrar, Ball’s Bridge, Dublin, Ireland. 1305 Lincoln Red ...... Lincoln Red Herd Book ...... Lincoln Red Cattle Society, W. Dunnaway secretary, Agri- culture House, Park St., Lincoln, England. 1209 Red Danish...... Stambog over Koer af Rod De Samvirkende Danske Landboforeninger, A. Wulff Pe- Dansk Malkerace. dersen, secretary, Vindegade 72, Odense, Denmark. Stambog over Tyre af Rod Dansk Malkerace. Register-Stambog over Kvaeg af Rod Dansk Malkerace. 1306 Red Poll ...... Red Poll Herd Book ...... Red Poll Cattle Society of Great Britain and Ireland, Inc., A. C. Burton, secretary, 32 Princes St., Ipswich, Suffolk, England. 1307 Shorthorn ...... Coates’s Herd Book ...... Shorthorn Society of Great Britain and Ireland, Arthur Greenhalgh, secretary, Victoria House, Southampton Row, London, W.C. 1, England.

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CATTLE—Continued

Code Name of breed Book of record By whom published

1107 South Devon ...... Herd Book of South Devon Cat- South Devon Herd Book Society, W. G. Turpitt, secretary, tle. 16 Sherborne Rd., Newton Abbot, Devon, England. 1115 Simmental ...... Irish Simmental Cattle Society ... Irish Simmental Cattle Society Ltd., Springhill Carrigtwohill, Co. Cork, Ireland. 1308 Sussex ...... Sussex Herd Book ...... Sussex Herd Book Society, A. G. Holland, secretary, 17 Devonshire St., London, W. 1, England. 1309 Welsh ...... Welsh Black Cattle Herd Book ... Welsh Black Cattle Society, G. Williams Edwards, secretary, 13 Bangor St., Caernarvon, No. Wales.

HORSES

Code Name of breed Book of record By whom published

2201 Arabian ...... Arab Horse Stud Book ...... The Arab Horse Society, Col. R. C. de V. Askin, secretary, Beechmead, Rowledge, Farnham, Surrey, England. 2202 ...... do ...... Polska Ksiega Stadna Koni, Towarzystwo Hodowli Konia Arabskiego, Maria Arabskich Czystej Krwi. Brykczynska, secretary, Krako 1w, Sarego 2, Poland. 2203 ...... do ...... General Stud Book ...... Weatherby & Sons, 15 Cavendish Sq., London, W. 1, Eng- land. 2204 ...... do ...... Registro-Matricula de Caballos Jefatura de Cria Caballar y Remonta, Don Manuel Diaz de Pura Sangre. Calderon, Secretario Stud-book, Ministerio del Ejercito, Madrid, Spain. 2205 ...... do ...... Stud Book Argentino...... Ministerio de Hacienda de la Nacion, Loteria de Beneficencia Nacional y Casinos, Ricardo A. Maestri, Jefe, Av. Libertador General San Martin 4101, Capital Federal, Republica Argentina. 2206 ...... do ...... Stud Book Francais Registre des Commission du Studbook Francais de Pur Sang, M. Maze- Chevaux de Pur Sang. Sencier, Inspecteur General, Chef, Service des Haras, Ministere de l’Agriculture, 78 rue de Varenne (7), Paris, France. 2207 ...... do ...... Stud Book de Venezuela ...... Instituto Nacional de Hipodromos, Jorge Coll Nunez, Jefe, Hipodromo ‘‘La Rinconada,’’ Caracas, Venezuela. 2208 ...... do ...... The Arabian Stud Book. (Rec- The Arabian Horse Club Registry of America, Inc., Henry ognition of this book will be re- B. Babson, secretary, 120 So. La Salle St., Chicago 3, stricted to Arabian horses Ill. which originate for importation in Saudi Arabia, or trace to pure Arabian stock of that country.). 2304 ...... do ...... Russian Arabian Stud Book of Ministry of Agriculture USSR, All-Union Research Institute Moscow, Union of Soviet So- of Horsebreeding. cialist Republics. 2101 Belgian ...... Stud-Book des Chevaux de Trait Societe 1 Royale ‘‘Le Cheval de Trait Belge,’’ Edgard Belges. Bedoret, Secretaire general, 45a rue de l’Ecuyer, Brus- sels, Belgium. 2209 Cleveland Bay ...... Cleveland Bay Stud Book ...... Cleveland Bay Horse Society, Oswald Welford, secretary, The Angelus, Roxby, Staithes, Saltburn, Yorkshire, Eng- land. 2102 Clydesdale ...... Clydesdale Stud-Book ...... Clydesdale Horse Society of Great Britain & Ireland, Rob- ert Jarvis, secretary, 19 Hillington Gardens, Glasgow, S.W. 2, Scotland. 2210 Criolla ...... ‘‘Registre Definitivo Seccion’’ de Sociedad Rural Argentina, E. F. Garay, Gerente Tecnico, Registro Genealogico para la Florida 460, Buenos Aires, Argentina. Raza Criolla. 2301 Fjordhest (formerly Stambok over Fjordhest...... Statens Stambokkontor, Arne Hogstad, Statens known as Stambokforer, Munkedamsveien 35 VI, Oslo, Norway. Westland). 2211 Hackney ...... Hackney Stud Book ...... Hackney Horse Society, R. A. Brown, secretary, 16 Bed- ford Sq., London, W.C. 1, England. 2212 Holstein ...... Holsteinisches Gestutbuch ...... Verband der Zuchter des Holsteiner Pferdes e. V., Herr H. Horstmann, Geschaftsfuhrer, Klostersande 93, Elmshorn, Germany. 2112 Morab ...... Morab Stud Book ...... North American Morab Horse Association, Inc., W 3174 Fero Springs Road, Hilbert, WI 54129. 2103 Percheron ...... British Percheron Stud Book ...... British Percheron Horse Society, A. E. Vyse, secretary, Owen Webb House, Gresham Rd., Cambridge, England. 2104 ...... do ...... Stud-Book Percheron de France Societe 1 Hippique Percheronne de France, E. Lemarie, secretaire general, 7 rue Villette-Gate 1. Nogent-le- Rotrou (E–&–L), France. 2302 Shetland Pony ...... Shetland Pony Stud-Book ...... Shetland Pony Stud-Book Society, Thomas H. F. Myles, secretary, 61 George St., Perth, Scotland.

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HORSES—Continued

Code Name of breed Book of record By whom published

2105 Shire ...... Shire Horse Stud Book ...... Shire Horse Society, A. G. Holland, secretary, 17 Devon- shire St., London, W. 1, England. 2106 Suffolk ...... Suffolk Stud-Book ...... Suffolk Horse Society, Raymond Keer, secretary, 6 Church St., Woodbridge, Suffolk, England. 2213 Thoroughbred ...... Australian Stud Book ...... Australian Jockey Club and Victoria Racing Club, W. J. McFadden, Keeper of the Stud Book, 6 Bligh St., Syd- ney, N.S.W., Australia. 2214 ...... do ...... General Stud Book ...... Weatherby & Sons, 15 Cavendish Sq., London, W. 1, Eng- land. 2215 ...... do ...... Jamaica Stud-Book ...... The Jockey Club of Jamaica, Miss L. Pike, secretary, 10 Duke St., Kingston, Jamaica, B.W.I. 2216 ...... do ...... Stud Book de Chile ...... Club Hipico de Santiago, Alejandro Obolensky Dadian, Jefe de Stud-Book, Casilla 3674, Santiago, Chile. 2217 ...... do ...... Stud Book de Venezuela ...... Instituto Nacional de Hipodromos, Jorge Coll Nunez, Jefe, Hipodromo ‘‘La Rinconada,’’ Caracas, Venezuela. 2218 ...... do ...... New Zealand Stud Book ...... New Zealand Racing Conference, A. M. McBeath, secretary, P.O. Box 1430, Wellington, C. 1, New Zealand. 2219 ...... do ...... Registro-Matricula de Caballos Jefatura de Cria Caballar y Remonta, Don Manuel Diaz de Pura Sangre. Calderon, Secretario Stud-book, Ministerio del Ejercito, Madrid, Spain. 2220 ...... do ...... Stud Book Francais Registre des Commission du Studbook Francais de Pur Sang, M. Maze- Chevaux de Pur Sang. Sencier, Inspecteur General, Chef, Service des Haras, Ministere de l’Agriculture, 78 rue de Varenne (7), Paris, France. 2221 ...... do ...... Libro Genealogico dei Cavalli di Jockey Club Italiano, Gen. Federico Garofoli, segretario, Puro Sangue. Corso Vittorio Emanuele 87, Rome, Italy. 2222 ...... do ...... Registre des Chevaux de Pur Jockey-Club de Belgique, Lt. Col. Baron Jacques van Sang. Zuylen van Nyevelt, Secretaire general, 1 rue Guimard, Brussels 4, Belgium. 2223 ...... do ...... Stud Book Brasileiro ...... Jockey Club Brasileiro, Ricardo Xavier da Silveira, Diretor do Stud Book, Av., Rio Branco 197, Rio de Janeiro, Brazil. 2224 ...... do ...... Stud Book Peruano ...... Jockey Club del Pera, Alberto Alvarez Calderon, Gerente, Union 1066, Lima, Peru. 2225 ...... do ...... Stud Book Argentino...... Ministerio de Hacienda de la Nacion, Loteria de Beneficencia Nacional y Casinos, Ricardo A. Maestri, Jefe, Av. Libertador General San Martin 4101, Capital Federal, Republica Argentina. 2226 ...... do ...... American Stud Book. (Recogni- The Jockey Club, Mrs. L. Brennan, Registrar, 300 Park tion of this book will be re- Ave., New York 22, N.Y. stricted to Thoroughbreds imported as follows: (a) Horses bred or born in the United States, shipped to a foreign country and returned to this country; (b) horses bred or born in Great Britain, Northern Ireland, Eire, or France, whose pedigrees trace wholly, or in part, to horses bred or born in the United States; (c) horses from countries where a book of purebred registration for Thoroughbreds does not exist; or (d) horses previously certified for entry under the act and for which Certificates of Foreign Registration were issued by The Jockey Club of New York, and which were subsequently exported to any country and returned to the United States with such certificates.). 2233 ...... do ...... Allgemeines deutsches Direktorium fur Vollblutzucht und Rennen, 6 Cologne Gestubuch fur Vollblut. Weidenpesch, Rennbahnstrasse 100, Postfach 180, Re- public of Germany. 2234 ...... do ...... Stud Book Uruguayo ...... Jefe del Stud Book Uruguayo, Jose C. Frigerio, Head, Uru- guayan Jockey Club, Montevideo, Uruguay. 2235 ...... do ...... The General Stud Book of South The Jockey Club of South Africa, Box 3409, Johannes- Africa. burg, Union of South Africa.

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HORSES—Continued

Code Name of breed Book of record By whom published

2113 Trakehner ...... Trakehner Stud Book ...... American Trakehner Association, 2305 November Lane, Reston, VA 22091. 2303 Welsh Pony and Cob Welsh Stud Book ...... Welsh Pony & Cob Society, J. A. George, secretary, Of- fices of the Royal Welsh Agricultural Society, Queen’s Rd., Aberystwyth, Cardiganlshire, Wales. 2240 Wielkopolskich...... Ksiega Stadna Koni Warm Blood & Full Blood Breeders of the Great Polish Wielkopolskich. Horses, Pulewski 14, 02–152 Warsaw, Poland.

ASSES

Code Name of breed Book of record By whom published

3001 Poitou ...... Jack and Jennet Section of Societe Centrale d’Agriculture des Deux-Sevres R. Marti- Stud-Book ou Livre net, Secretaire, Cite Administrative, rue Duguesclin, Niort Genealogique des Animaux (Deux-Sevres), France. Mulassiers due Poitou.

SHEEP

Code Name of breed Book of record By whom published

4101 Border Leicester ...... Border Leicester Flock Book ...... Society of Border Leicester Sheep Breeders, Robert Jarvis, secretary, Room 273, 93 Hope St., Glasgow, C. 2, Scot- land. 4102 Cheviot ...... Cheviot Sheep Flock Book...... Cheviot Sheep Society, Guy H. Armstrong, secretary, Commercial Bank Bldgs., Hawick, Scotland. 4103 Corriedale ...... Flock Book for Corriedale Sheep The Australian Corriedale Association, H.T.C. Woodfull, in Australia. secretary, Royal Showgrounds, Epsom Road, Ascot Vale, W. 2, Victoria, Australia. 4104 ...... do ...... Corriedale Flock Book (New The Corriedale Sheep Society, Inc., C. H. Lawrence, sec- Zealand). retary, 154 Hereford St., Christchurch, New Zealand. 4201 Dorset Horn ...... Dorset Horn Flock Book ...... Dorset Horn Sheep Breeders’ Association, E. F. B. Lucas, secretary, Bank Chambers, Dorchester, Dorset, England. 4202 Hampshire Down ...... Hampshire Down Flock Book ..... Hampshire Down Sheep Breeders’ Association, Miss Doris M. Stanbury, secretary, 38 Endless St., Salisbury, Wilts., England. 4105 Kent or Romney Kent or Romney Marsh Flock Kent or Romney Marsh Sheep-Breeders’ Association, G. Marsh. Book. W. Tuffrey, secretary, Station Rd., Ashford, Kent, Eng- land. 4203 Kerry Hill ...... Kerry Hill Flock Book ...... Kerry Hill (Wales) Flock Society, Ralph P. Evans, secretary, c/o The Radnorshire Co., Ltd., Knighton, Radnorshire, Wales. 4106 Leicester ...... Leicester Flock Book ...... Leicester Sheep Breeders’ Association, P. S. Atkinson, secretary, The Exchange, Exchange St., Driffield, E. Yorks., England. 4107 Lincoln ...... Flock Book of Lincoln Longwool Lincoln Longwool Sheep Breeders’ Association, Brian Sheep. Shelley, secretary, Westminster Bank Chambers, 8 Guildhall St., Lincoln, England. 4204 Oxford Down...... Flock Book of Oxford Down Oxford Down Sheep Breeders’ Association, Mrs. L. I. Dea- Sheep. con, secretary, Thornyfields, Billing Rd., Brafield-on-the- Green, Northampton, England. 4108 Romney Marsh...... New Zealand Romney Marsh New Zealand Romney Marsh Sheep Breeders’ Associa- Flock Book. tion, Inc., R. J. J. Campbell, secretary, 117 Kimbolton Rd., Feilding, New Zealand. 4205 Ryeland ...... Ryeland Flock Book ...... Ryeland Flock Book Society, Ltd., P. J. Hoskins, secretary, 20 King St., Hereford, England. 4206 Shropshire ...... Shropshire Flock Book ...... Shropshire Sheep Breeders’ Association and Flock Book Society, Ivor Guy Mansell, secretary, College Hill, Shrewsbury, Shropshire, England. 4207 Southdown ...... Southdown Flock Book ...... Southdown Sheep Society, Inc., R. G. Noakes, secretary, Westways, Barming Woods, Maidstone, Kent, England. 4218 ...... do ...... Southdown Sheep Society of The Southdown Sheep Society of New Zealand (Inc.), S. I. New Zealand (Inc.). McKenzie, secretary, A.M.P., Chambers, 14 Broadway, Palmerston North, New Zealand. 4208 Suffolk ...... Suffolk Flock Book ...... Suffolk Sheep Society, Harry A. Byford, secretary, 30 Mu- seum St., Ipswich, Suffolk, England. 4109 Wensleydale ...... Wensleydale Longwool Sheep The Wensleydale Longwool Sheep Breeders’ Association, Flock Book. W. Dickinson, secretary, ‘‘Cartmel,’’ Church Walk, Ulverston, Lancashire, England.

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SHEEP—Continued

Code Name of breed Book of record By whom published

4001 Various recognized Flock Book for British Breeds of Australian Society of Breeders of British Sheep, H.T.C. breeds. Sheep in Australia. Woodfull, secretary, Royal Show Grounds, Epsom Rd., Ascot Vale, W. 2, Victoria, Australia. 4002 ...... do ...... New Zealand Flock Book...... New Zealand Sheep Breeders’ Association, H.M. Studholme, secretary, P.O. Box 9002, Addington, Christ- church, New Zealand.

GOATS

Code Name of breed Book of record By whom published

5001 Saanen and British Goat Society Herd Book British Goat Society, Miss M.F. Rigg, secretary, Diss, Nor- Toggenburg. (Saanen and Toggenburg folk, England. Sections).

SWINE

Code Name of breed Book of record By whom published

6001 Irish Large White ...... Herd Book of Irish Large White Royal Dublin Society, Horace H. Poole, registrar, Ball’s Pigs. Bridge, Dublin, Ireland. Berkshire. Gloucestershire Old. Spots.. Large Black. 6002 Large White...... Herd Book of the National Pig National Pig Breeders’ Association, E.G. Wake, secretary, Middle White ...... Breeders’ Association. 69 Clarendon Rd., Watford, Herts, England Tamworth. British Saddleback.

DOGS

Code Name of breed Book of record By whom published

7306 Australian Kelpie ...... The Working Kelpie Council Na- The Working Kelpie Council, P.O. Box E31 St. James, Sid- tional Stud Book. ney 2000, Australia. 7301 Boxer ...... Boxer-Zuchtbuch ...... Boxer-Klub e. V. Sitz Munchen, Bernhard Schmitz, Prasident, 38 Otkerstrasse, Munchen 9, Germany. 7201 Dachshund...... Teckel-Stammbuch ...... Deutscher Teckelklub e. V., Josef Chateau, Stammbuchfuhrer, Vallendar/Rhein, Haus Rheinnieder, Germany. 7202 Foxhound ...... Foxhound Kennel Stud Book ..... Masters of Foxhounds Association, Lt. Col. J. E. S. Chamberlayne, Hon. secretary, 51 Victoria St., London, S. W. 1, England. 7203 ...... do ...... Welsh Hound Stud Book ...... Welsh Hound Association, Islwyn E. E. Davies, Hon. secretary, Berthddu, Llandinam, Montgomeryshire, East Wales. 7302 German Shepherd.... Zuchtbuch fur deutsche Verein fur deutsche Schaferhunde (SV), Hann Schaferhunde (SZ). Kremhelmer, Hauptgeschaftsfuhrer, Beim Schnarrbrunnen 4, Augsburg 5, Germany. 7303 Great Dane ...... Zuchtbuch fur Deutsche Doggen Deutscher Doggen-Club, Richard Staadt, Prasident, Ellerstrasse 25, Solingen-Ohligs, Germany. 7204 Greyhound ...... Australian Greyhound Stud Book The Australian and New Zealand Greyhound Association, Robert John Maidment, secretary, 349 Collins St., Mel- bourne, C. 1, Australia. 7205 ...... do ...... Greyhound Stud Book ...... National Coursing Club, Sydney H. Dalton, secretary, Col- lege Hill Chambers, London, E.C. 4. England. 7206 ...... do ...... Irish Greyhound Stud Book ...... Irish Coursing Club, Miss K. Butler, secretary, Davis Rd., Clonmel, Co. Tipperary, Ireland. 7207 Harrier and Beagle ... Harrier and Beagle Stud Book ... Association of Masters of Harriers and Beagles, J. J. Kirk- patrick, Hon. secretary, East Wing, Kirtlington Park, Ox- ford, England. 7304 Rottweiler ...... Zucht- und Korbuch...... Allgemeiner Deutscher Rottweiler-Klub, Mrs. Josephine Rieble, Sekretarin, Vorsteigstrasse 5, Stuttgart-West, Germany. 7305 St. Bernard...... Bernhardiner-Zuchtbuch ...... St. Bernhardsklub e. V., Franz Hrachowina, Zuchtbuchfuhrer, Bergmannstrasse 35, Munchen 12, Germany.

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DOGS—Continued

Code Name of breed Book of record By whom published

7001 Various recognized Irish Kennel Club Stud Book ...... Irish Kennel Club, Miss Maud C. Fox, secretary, 23 Eden breeds. Quay, Dublin, C. 8, Ireland. 7002 ...... do ...... Kennel Club Stud Book ...... English Kennel Club, E. Holland Buckley, secretary, 1–4 Clarges St., Piccadilly, London, W. 1, England. 7003 ...... do ...... Livre des Origines Francais ...... Societe 1 Centrale Canine pour l’Amelioration des Races de Chiens en France, Col. Raoul Nicole, Directeur Administrateur, 3 Rue de Choiseul, Paris 2, France. 7004 ...... do ...... Livre des Origines de la Societe Societe 1 Royale Saint-Hubert, R. Willocq, Secretaire 1, 1 Royale Saint-Hubert. 391 Chaussee Saint-Pierre, Brussels 4, Belgium. 7005 ...... do ...... Norsk Kennelklubs Stambok...... Norsk Kennel Klub, Olaf A. Roig, secretary, Bjorn Farmannsgate 16, Oslo, Norway. 7006 ...... do ...... Zuchtbuch des Klub fur Terrier Klub fur Terrier e.V., Wilhelm Vahle, Sekretar, Schone e. V. Aussicht 9, Kelsterbach b. Frankfurt/Main, Germany. 7007 ...... do ...... Schweizerisches Hunde- Schweizerische Kynologischen Gesellschaft, Carl Wittwer, Stammbuch. secretary, Seestrasse 64, Kilchberg/Zurich, Switzerland. 7008 ...... do ...... Svenska Kennelklubbens Reg- Svenska Kennelklubben, Ivan Swedrup, secretary, ister. Linnegatan 25, Stockholm O 4, Sweden.

CATS

Code Name of breed Book of record By whom published

8001 Long-haired and The Governing Council of the The Governing Council of the Cat Fancy, W.A. Hazeldine, short-haired. Cat Fancy Stud Book. secretary, 1 Roundwood Way, Banstead, Surrey, Eng- land.

(b) Breeds and books of record in Can- Code Name of breed Code Name of breed ada—(1) Animals generally. The books of record of the Canadian National Live 1212 Canadian. 1311 Lincoln Red. 1310 Dexter. 1312 Red Poll. Stock Records, Ottawa, Canada, of 1109 Galloway. 1313 Shorthorn. which F. G. Clark is Director, are rec- 1114 Gelbvieh ognized for the following breeds: Pro- 1213 Guernsey. vided, That no animals registered in HORSES the Canadian National Live Stock Records shall be certified under the act 2227 American Saddle 2109 Percheron. as purebred unless such animals trace Horse. only to animals which are proved to 2228 Arabian. 2304 Shetland Pony. the satisfaction of Veterinary Services 2107 Belgian Draft. 2110 Shire Suffolk. to be of the same breed: Provided fur- 2229 Canadian. 2111 Thoroughbred. ther, That no Dexter cattle, Karakul 2108 Clydesdale. 2232 Welsh Pony. sheep, Alpine goat, Nubian goat, or 2230 Hackney. 2305 and Cob. horse of the American Saddle Horse, 2236 Morgan. Arabian, Canadian, Morgan, Shetland SHEEP Pony or Welsh Pony and Cob breed in Canada shall be certified under the act 4110 Blackface. 4115 Lincoln. as purebred unless a pedigree certifi- 4111 Cheviot. 4116 Merino. cate showing three complete genera- 4112 Corriedale. 4213 Oxford Down. tions of known and recorded purebred 4113 Cotswold. 4117 Rambouillet. 4209 Dorset Horn. 4214 Ryeland. ancestry of the particular breed in- 4210 Hampshire. 4215 Shropshire. volved, issued by the Canadian Na- 4211 Karakul. 4216 Southdown. tional Live Stock Records, is sub- 4212 Kerry Hill. 4217 Suffolk. mitted for such animal. 4114 Leicester.

Code Name of breed Code Name of breed GOATS

CATTLE Alpine. Angora. 1108 Aberdeen, Angus. 5002 Nubian. 1210 Ayrshire. 1111 Highland. Saanen. 1110 Belgian Blue Toggenburg. 1211 Brown Swiss. 1214 Jersey.

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Code Name of breed Code Name of breed National Live Stock Records, is recognized for the Maine-Anjou breed reg- SWINE istered in the Canadian Maine-Anjou Berkshire. Herd Book: Provided, That no Maine- Chester White. Anjou cattle so registered shall be cer- Duroc-Jersey. tified under the act as purebred unless Hampshire. a pedigree certificate showing at least Lacombe. 6003 Landrace. three generations of known and re- Large Black. corded purebred ancestry of the breed Poland China. involved, issued by the Canadian Na- Tamworth. tional Live Stock Records, is sub- British Saddleback. Yorkshire. mitted for each such animal. (7) Simmental cattle in Canada (Code (2) Holstein-Friesian cattle in Canada 1114). The Canadian Simmental Asso- (Code 1215). The Holstein-Friesian Asso- ciation, Calgary, Alberta, Canada, of ciation of Canada, Brantford, Ontario, which Mr. John Kish is Executive Sec- Canada, of which G. M. Clemons is secretary, is recognized for the Simmental retary and editor, is recognized for the breed registered in the Canadian Holstein-Friesian breed registered in Simmental Association Full Blood the Holstein-Friesian Herd Book of Herd Book: Provided, That no that Association. simmental cattle so registered shall be (3) Dogs in Canada (Code 7009). The certified under the act as purebred un- Stud Book of the Canadian Kennel less a pedigree certificate showing at Club, Incorporated (Canadian National least three generations of known and Live Stock Records) is recognized for recorded purebred ancestry of the breed all the breeds of dogs registered there- involved, issued by the Canadian in: Provided, That no dog so registered Simmental Association is submitted shall be certified under the act as pure- for each such animal. bred unless a pedigree certificate show- (8) Hereford cattle in Canada (Code ing three complete generations of 1110). The Canadian Hereford Herd known and recorded purebred ancestry Book of The Canadian Hereford Asso- of the particular breed involved, issued ciation, 5160 Skyline Way NE., Calgary, by the Canadian Kennel Club, Incor- Alberta, Canada, of which Dr. Duncan porated, is submitted for such dog. J. Porteous is General-Manager, is rec- (4) Standardbred horses in Canada ognized for the Hereford breed reg- (Code 2231). The Canadian Standard istered therein. Bred Stud Book kept by the Canadian [23 FR 10104, Dec. 23, 1958] Standard Bred Horse Society, 122 EDITORIAL NOTE: For FEDERAL REGISTER ci- Brown’s Line, Toronto 14, Ontario, tations affecting § 151.9, see the List of CFR Canada, is recognized for all Sections Affected, which appears in the Standardbred horses registered therein: Finding Aids section of the printed volume Provided, That no Standard bred so reg- and at www.fdsys.gov. istered shall be certified under the act as purebred unless a pedigree certifi- § 151.10 Recognition of additional cate showing three complete genera- breeds and books of record. tions of known and recorded purebred Before a breed or a book of record Standardbred ancestry, issued by the shall be added to those listed in this Canadian Standard Bred Horse Society, part, the custodian of the book of is submitted for each such horse. record involved shall submit to APHIS (5) Charolais cattle in canada (Code a complete copy of the book of record, 1112). The full French book of record of consisting of any published printed vol- the Canadian Charolais Association, umes and any microfilm records issued Calgary, Alberta, Canada, is recognized by the registry association up to date for the Charolais breed registered of application, together with a copy of therein. all rules and forms in force on said date (6) Maine-Anjou cattle in Canada (Code affecting the registration of animals in 1113). The full French book of record of said book. the Canadian Maine-Anjou Association, [24 FR 2644, Apr. 7, 1959, as amended at 54 FR which is maintained by the Canadian 34970, Aug. 23, 1989]

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§ 151.11 Form of books of record. printed volumes and shall otherwise be (a) If a registry association has not in approved form. published its book of record in printed (b) A microfilm record will be ap- form, a record in approved microfilm proved under this part only if it is 16 form which the Administrator finds mm. non-perforated safety film ex- provides a system for determining the posed at a reduction ratio not to ex- recorded ancestry of the animals iden- ceed 24 diameters. All information on tified therein will be acceptable. When the original document shall be repro- a registry association which has pub- duced onto the microfilm so that it is lished its book of record in printed clearly readable. The microfilm carton form ceases such publication and in shall be indexed to state the numbers lieu thereof publishes a microfilm of the pedigree certificates on the roll record, the microfilm record shall com- of film it contains. mence with the first pedigree recorded [24 FR 2644, Apr. 7, 1959, as amended at 54 FR by the association which is not in the 34969, Aug. 23, 1989]

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PART 156—VOLUNTARY INSPEC- ship, society, joint stock company, or TION AND CERTIFICATION SERV- other form of organization. ICE [23 FR 10111, Dec. 23, 1958, as amended at 57 FR 30899, July 13, 1992; 62 FR 19040, Apr. 18, Sec. 1997; 72 FR 70766, Dec. 13, 2007] 156.1 Meaning of words. 156.2 Definitions. § 156.3 Kind of service; records. 156.3 Kind of service; records. Laws, regulations or other require- 156.4 Application for service. ments of foreign countries and speci- 156.5 Availability of service. fications of contracts for the purchase 156.6 Certificates. and sale of animal products, on occa- 156.7 User fees under 9 CFR part 130. sion require vendors of such products 156.8 Refusal of service; denial or withdrawal of service. to furnish official certificates concerning the class, quality, quantity, or AUTHORITY: 7 U.S.C. 1622 and 1624; 21 U.S.C. condition of such products to be im- 136a; 7 CFR 2.22, 2.80, and 371.4. ported into such countries or to be de- SOURCE: 23 FR 10111, Dec. 23, 1958, unless livered under the contracts. The serv- otherwise noted. ice under this part, shall consist of the inspection of the processing, handling, § 156.1 Meaning of words. and storage of the products at any Words used in this part in the sin- plant at which service is furnished and gular form shall import the plural, and the certification, on the basis of such vice versa, as the case may demand. requirements of foreign countries or such contract specifications, of the § 156.2 Definitions. class, quality, quantity, or condition of For the purposes of this part, unless such of the products as are found to the context otherwise requires, the fol- conform to such requirements or speci- lowing terms shall be construed, re- fications as the case may be. Proc- spectively, to mean: essing procedures will be actually su- Administrator. The Administrator, pervised. The operator of the plant Animal and Plant Health Inspection shall fully inform the inspector with Service, or any person authorized to respect to, and the inspector shall ac- act for the Administrator. tually observe, the processing proce- Animal product. Anything made of, dures, handling, and storage of the derived from, or containing any mate- products intended for certification. rial of animal origin. The inspector shall keep such records Applicant. Any person who requests of the temperatures reached, the dura- service under this part. tion of time the temperatures are Department. The United States De- maintained, and the pounds of pressure partment of Agriculture. under which the products are cooked in Inspector. Any officer or employee of the course of processing, and such the Department of cooperating agency other information, as are needed to jus- authorized to perform any duties at tify the issuance of the certificates re- any plant furnished service under this quired. part. Inspector in charge. An inspector of [23 FR 10111, Dec. 23, 1958, as amended at 62 the Department assigned by the Ad- FR 19040, Apr. 18, 1997] ministrator to supervise, review, and § 156.4 Application for service. perform official work pertaining to a plant furnished service under this part. Any person who is eligible to receive Person. Any individual, corporation, service under this part may apply company, association, firm, partner- therefor to the Administrator, upon an

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application form which will be fur- § 156.7 User fees under 9 CFR part 130. nished by the Administrator upon re- User fees under part 130 of this chap- quest. The application form shall re- ter for service (including travel and quire the applicant to state, among other expenses incurred in connection other things, the forms of certificates with the furnishing of service) under desired. this part shall be paid by the applicant. (Approved by the Office of Management and If required by the Administrator, the Budget under control number 0579–0008) user fees under part 130 of this chapter [23 FR 10111, Dec. 23, 1958, as amended at 48 shall be paid in advance. Since the user FR 57473, Dec. 30, 1983; 57 FR 30899, July 13, fees under part 130 of this chapter are 1992; 72 FR 70766, Dec. 13, 2007] for the purpose of reimbursing the De- partment for all costs incurred in con- § 156.5 Availability of service. nection with the furnishing of service Subject to § 156.8, service under this under this part, the appropriate user part will be furnished, upon applica- fees under part 130 of this chapter to cover any such costs shall be paid even tion, within the limits of available De- if service is withheld pursuant to partment personnel and facilities, at § 156.8. any plant the operator of which applies for or endorses the application for the [72 FR 70766, Dec. 13, 2007] service if the Administrator finds that: the forms of certificates desired by the § 156.8 Refusal of service; denial or applicant require the certification of withdrawal of service. class, quality, quantity, or condition; (a) Service under this part will be re- the plant and its methods of proc- fused if the conditions stated in §§ 156.5 essing, handling and storage of the and 156.6 are not met. products intended for certification are (b) Service under this part may be adequate to warrant the issuance of withdrawn from, or denied to, any ap- the desired certificates; the require- plicant by the Administrator, for such ments of part 130 of this title are met; period as the Administrator may pre- and the requirements of § 156.7 are met. scribe, when the Administrator is satisfied, after opportunity for hearing be- [23 FR 10111, Dec. 23, 1958, as amended at 57 FR 30899, July 13, 1992; 62 FR 19040, Apr. 18, fore a proper official has been accorded 1997; 72 FR 70766, Dec. 13, 2007] the applicant, that the applicant or other operator of the plant where serv- § 156.6 Certificates. ice has been or would be furnished under the application, or the agent or The inspector shall sign and issue employee of such applicant or operator certificates in forms approved by the within the scope of his employment, Administrator for animal products, if has persistently failed to give the in- the inspector finds that the require- spector full and correct information ments as stated in the certification with respect to the processing proce- have been met. The original and one dures, handling, and storage of animal copy of each certificate shall be fur- products intended for certification or nished to the applicant, and one copy certified; or has given to any employee of each certificate shall be retained by of the Department false information in the Department until disposal is au- connection with service under this thorized in accordance with law. Addi- part; or has altered or imitated any tional copies may be furnished the ap- certificate, mark, or device provided plicant at his request upon payment of for under this part; or has used any the fees prescribed in § 156.7. Copies of such certificate, mark, or device with- the certificates may be furnished without authority from the Administrator, out charge to other properly interested or any imitation of any such certifi- Federal agencies or under compulsory cate, mark, or device, on or with reprocess. spect to any animal products; or has [23 FR 10111, Dec. 23, 1958, as amended at 57 knowingly and without promptly noti- FR 30899, July 13, 1992; 62 FR 19040, Apr. 18, fying the Administrator retained pos- 1997] session of any such device or imitation

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thereof or altered or imitation certifi- out hearing, and in that event shall re- cate or of any animal products marked port his actions to the Administrator, with any such device without author- and the Administrator may continue ity from the Administrator or marked such suspension or otherwise deny or with any imitation of such device; or suspend service at any plant for any of has given or attempted to give, for any such reasons, without hearing, pending purpose whatsoever, any money, favor, final disposal of the matter under this or other thing of value, to any em- paragraph. ployee of the Department authorized to (c) All final orders in any proceeding perform any function under this part; to deny or withdraw the service for any or has interfered with or obstructed, or of the reasons set forth in paragraph attempted to interfere with or to ob- (b) of this section (except orders re- struct, any employee of the Depart- quired for good cause to be held con- ment in or with respect to the perform- fidential and not cited as precedents) ance of his duties under this part by in- shall be filed with the Hearing Clerk of timidation, threats, assaults, or any the Department and be available to other improper means. The inspector public inspection. assigned to any plant may suspend [23 FR 10111, Dec. 23, 1958, as amended at 57 service at such plant for any of the rea- FR 30899, July 13, 1992; 62 FR 19040, Apr. 18, sons set forth in this paragraph, with- 1997]

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PART 160—DEFINITION OF TERMS or bodily function is suggestive of clinical signs of communicable disease. Herd or flock health plan. A written AUTHORITY: 7 U.S.C. 8301–8317; 15 U.S.C. herd or flock health management plan, 1828; 7 CFR 2.22, 2.80, and 371.4. which may include an agreement § 160.1 Definitions. signed by the owner of a herd or flock, the accredited veterinarian, and a For the purposes of this subchapter State or APHIS representative, in the following words, phrases, names which each participant agrees to un- and terms shall be construed, respec- dertake actions specified in the agree- tively, to mean: ment to maintain the health of the ani- Accredited veterinarian. A veteri- mals and detect signs of communicable narian approved by the Administrator disease. in accordance with the provisions of Inspect, inspection. Visual study of part 161 of this subchapter to perform the physical appearance, physical con- functions specified in subchapters B, C, and D of this chapter. dition, and behavior of animals (singly or in groups) that enables an accred- Administrator. The Administrator of the Animal and Plant Health Inspec- ited veterinarian to determine whether tion Service or any individual author- any abnormality in physical condition ized to act for the Administrator. or bodily function is evident. Animal, animals. All animals except Issue. The distribution, including humans, including but not limited to electronic transmission, of an official cattle, sheep, goats, other ruminants, animal health document that has been swine, horses, asses, mules, zebras, signed. birds, and poultry. Official certificate, form, record, report, Animal and Plant Health Inspection tag, band, or other identification. Means Service. The Animal and Plant Health any certificate, form, record, report, Inspection Service, United States De- tag, band, or other identification, pre- partment of Agriculture. scribed by statute or by regulations APHIS. The Animal and Plant Health issued by the Administrator, for use by Inspection Service. an accredited veterinarian performing Approved digital signature. Digital sig- official functions under this sub- natures approved by the Administrator chapter. for electronic transmission, for exam- Qualified accredited veterinarian ple, via a computer. To be approved, a (QAV). An accredited veterinarian who digital signature must be able to verify has been granted a program certifi- the identity of the accredited veteri- cation by the Administrator pursuant narian signing the document and indi- to § 161.5 of this subchapter based on cate if the integrity of the data in the completion of an APHIS-approved ori- signed document was compromised. entation or training program. Category I animals. Any animals other Regular health maintenance program. than Category II animals, e.g., cats and An arrangement between an accredited dogs. veterinarian and a livestock producer Category II animals. Food and fiber whereby the veterinarian inspects animal species; horses; birds; farm- every animal on the premises of the raised aquatic animals; all other live- producer at least once every 30 days. stock species; and zoo animals that can Sign, (Signed). For an accredited vet- transmit exotic animal diseases to erinarian to put his or her signature in livestock. his or her own hand, or by means of an Examine, examination. Physical study approved digital signature, on a certifi- of an individual animal that enables an cate, form, record, or report. No certifi- accredited veterinarian to determine if cate, form, record, or report is signed any abnormality in physical condition if:

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(1) Someone other than the accred- § 161.1 Statement of purpose; require- ited veterinarian has signed it on be- ments and application procedures half of or in the name of the accredited for accreditation. veterinarian, regardless of the author- (a) This subchapter concerns a pro- ity granted them by the accredited vet- gram administered by APHIS to ac- erinarian; or credit veterinarians and thereby au- (2) If any mechanical device, other thorize them to perform, on behalf of than an approved digital signature, has APHIS, certain activities specified in been used to affix the signature. this chapter. This program is intended State. Any State, the District of Co- to ensure that an adequate number of lumbia, Puerto Rico, Guam, the North- qualified veterinarians are available in ern Mariana Islands, the Virgin Islands the United States to perform such ac- of the United States, and any other tivities. territory or possession of the United (b) Categories of accreditation. A vet- States. erinarian may be accredited as a Cat- State Animal Health Official. The egory I veterinarian or a Category II State animal health official who is re- veterinarian. A veterinarian who is ac- sponsible for the livestock and poultry credited under Category I is only au- disease control and eradication pro- thorized to perform accredited duties grams of a State. on Category I animals, as defined in Veterinarian-in-Charge. The veteri- § 160.1. A veterinarian who is accredited nary official of APHIS who is assigned under Category II is authorized to per- by the Administrator to supervise and form accredited duties on both Cat- perform the official work of APHIS in egory I animals and Category II ani- a State or group of States. mals. (c) Application for initial accreditation. [57 FR 54912, Nov. 23, 1992, as amended at 59 A veterinarian may apply for accredi- FR 40797, Aug. 10, 1994; 60 FR 39842, Aug. 4, 1995; 62 FR 25445, May 9, 1997; 73 FR 60488, tation by completing an application for Oct. 10, 2008; 74 FR 65010, Dec. 9, 2009] accreditation and submitting it to APHIS. In completing the application, the veterinarian will choose one of the PART 161—REQUIREMENTS AND accreditation activity categories, ei- STANDARDS FOR ACCREDITED ther Category I or Category II, as dis- VETERINARIANS AND SUSPEN- cussed in paragraph (b) of this section. SION OR REVOCATION OF SUCH Applications for Category I accredita- ACCREDITATION tion must include certification that the applicant is able to perform the Sec. tasks listed in paragraph (g)(1) of this 161.1 Statement of purpose; requirements section. Applications for Category II and application procedures for accredita- accreditation must include certifi- tion. cation that the applicant is able to per- 161.2 Performance of accredited duties in form the tasks listed in paragraph different States. (g)(2) of this section. An accredited vet- 161.3 Renewal of accreditation. erinarian must not perform duties re- 161.4 Standards for accredited veterinarian quiring a program certification unless duties. he or she is accredited under Category 161.5 Program certifications. II and qualified to perform such duties 161.6 Suspension or revocation of veterinary accreditation and reaccreditation; crimi- in accordance with § 161.5 of this part. nal and civil penalties. (d) Review of application. Applications 161.7 Activities performed by non-accred- for accreditation received by APHIS ited veterinarians. shall be forwarded to the State Animal Health Official for the State in which AUTHORITY: 7 U.S.C. 8301–8317; 15 U.S.C. the veterinarian wishes to perform ac- 1828; 7 CFR 2.22, 2.80, and 371.4. credited duties for approval. Within 14 SOURCE: 57 FR 54912, Nov. 23, 1992, unless days after receiving an application, a otherwise noted. State Animal Health Official shall either endorse the application or send a

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written statement to the Adminis- program shall include the following trator explaining why it was not en- topics: dorsed; but if the State Animal Health (i) Federal animal health laws, regu- Official fails to take one of these ac- lations, and rules; tions within 14 days, APHIS shall pro- (ii) Interstate movement require- ceed to review the application. The Ad- ments for animals; ministrator will review the application (iii) Import and export requirements and the written statement, if any, and for animals; determine whether the applicant meets (iv) USDA animal disease eradication the requirements for accreditation con- and control programs; tained in this part. (v) Laboratory support in confirming (e) Accreditation requirements. The Ad- disease diagnoses; ministrator is hereby authorized to ac- (vi) Ethical and professional respon- credit a veterinarian when he or she sibilities of an accredited veterinarian; determines that: (vii) Foreign animal disease aware- (1) The veterinarian is a graduate ness; with a Doctorate of Veterinary Medi- (viii) Animal health emergency man- cine or an equivalent degree (any de- agement; and gree that qualifies the holder to be li- (ix) Animal health procedures, issues, censed by a State to practice veteri- and information resources relevant to nary medicine) from a college of veteri- the State in which the veterinarian nary medicine; wishes to perform accredited duties. (2) The veterinarian is licensed or le- (f) Change in accreditation category. (1) gally able to practice veterinary medi- Category I to Category II. A veterinarian cine in the State in which the veteri- who is accredited under Category I narian wishes to perform accredited may become accredited under Category duties. APHIS will confirm the licens- II if the veterinarian applies for ac- ing status of the applicant by con- creditation under Category II by com- tacting the State board of veterinary pleting an application for accredita- medical examiners or any similar tion, including certification that the State organization that maintains applicant is able to perform the tasks records of veterinarians licensed in a listed in paragraph (g)(2) of this sec- State; tion, and submitting it to APHIS. The (3) The veterinarian has completed veterinarian must also have fulfilled initial accreditation training, using the training requirements in § 161.3(b) content provided by APHIS; and that are associated with renewal of ac- (4) The veterinarian has completed creditation under Category II. an orientation program approved by (2) Category II to Category I. A veteri- the Veterinarian-in-Charge for the narian who is accredited under Cat- State in which the veterinarian wishes egory II may become accredited under to perform accredited duties, and upon Category I if the veterinarian applies completion of the orientation, has for accreditation under Category I by signed a written statement listing the completing an application for accredi- date and place of orientation, the sub- tation, including certification that the jects covered in the orientation, and applicant is able to perform the tasks any written materials provided to the listed in paragraph (g)(1) of this sec- veterinarian at the orientation. The tion, and submitting it to APHIS. The Veterinarian-in-Charge shall also give veterinarian must also have fulfilled the State Animal Health Official an op- the training requirements in § 161.3(b) portunity to review the contents of the that are associated with renewal of ac- orientation, and invite him or her to creditation under Category I. participate in developing orientation (g) Tasks that applicants for accredited materials and conducting the orienta- status must be able to perform. Appli- tion. The veterinarian applying for ac- cants for accredited status must be creditation must have completed the able to: orientation program within 3 years (1) Category I. (i) Perform physical prior to submitting the application for examination of individual Category I accreditation. The core orientation animals to determine whether they are

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free from any clinical signs suggestive (vii) Properly complete certificates of communicable disease. for domestic and international move- (ii) Recognize the common breeds of ment of animals. Category I animals and accurately (viii) Apply and remove official seals. record breed information on official (ix) Perform necropsies on animals. documents. (x) Recognize and report clinical (iii) Apply common animal identi- signs and lesions of exotic animal dis- fication for Category I animals. eases. (iv) Properly complete certificates (xi) Develop a herd or flock health for domestic and international move- plan consistent with requirements in ment of Category I animals. subchapters B, C, and D of this chapter. (v) Perform necropsies on Category I (xii) Vaccinate for USDA program animals. diseases and accurately complete the vaccination certificate. (vi) Recognize and report clinical signs and lesions of exotic animal dis- (xiii) Properly collect and ship sample specimens to an appropriate labora- eases that occur in Category I animals. tory for testing with complete and ac- (vii) Vaccinate Category I animals curate paperwork. and accurately complete the vaccina- (xiv) Properly perform testing for tu- tion certificates. berculosis (e.g., caudal fold test). (viii) Properly collect and ship speci- (xv) Develop appropriate biosecurity men samples to the appropriate labora- protocols, as well as cleaning and dis- tory for testing with complete and ac- infection protocols, to control commu- curate paperwork. nicable disease spread. (ix) Develop appropriate biosecurity (xvi) Explain basic principles for con- protocols, as well as cleaning and dis- trol of diseases for which APHIS or infection protocols, to control commu- APHIS-State cooperative programs nicable disease spread in Category I presently exist. animals. (h) Authorization to perform duties. An (2) Category II. (i) Perform physical accredited veterinarian may not per- examination of individual animals and form accredited duties in a State until visually inspect herds or flocks to de- after receiving written authorization termine whether the animals are free from APHIS. If a Category I accredited from any clinical signs suggestive of veterinarian completes the necessary communicable disease. training requirements and becomes a (ii) Recognize the common breeds of Category II accredited veterinarian, Category I and Category II animals, in- the veterinarian may not perform Cat- cluding the types of poultry as defined egory II accredited duties in a State by the National Poultry Improvement until after receiving written authoriza- Plan in subchapter G of this chapter tion from APHIS. and the common breeds of livestock, (Approved by the Office of Management and and be able to accurately record breed Budget under control number 0579–0297) information on official documents. [57 FR 54912, Nov. 23, 1992, as amended at 74 (iii) Recognize all USDA animal iden- FR 65010, Dec. 9, 2009] tification systems. (iv) Estimate the age of livestock § 161.2 Performance of accredited du- using a dental formula. ties in different States. (v) Apply USDA-recognized identi- (a) If an accredited veterinarian fication (e.g., eartag, microchip, tat- wishes to perform accredited duties in too) for the USDA animal identifica- a State other than the State in which tion system. the veterinarian was initially accred- (vi) Certify the health status of an ited in accordance with § 161.1(e), the avian flock regarding diseases of do- accredited veterinarian must complete mestic or international regulatory con- an application to request authorization cern, and evaluate records pertaining to perform accredited duties in the new to poultry flock testing and participa- State from the Veterinarian-in-Charge tion in Federal and State poultry of that State. The Veterinarian-in- health programs and classifications. Charge of the new State may require

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the accredited veterinarian to com- plemental training units approved by plete, prior to performing any accred- APHIS by the end of their 3-year ten- ited duties in the new State, an ori- ure as an accredited veterinarian. Ac- entation in animal health procedures credited veterinarians who wish to and issues relevant to the new State. renew their accreditation under Cat- The Veterinarian-in-Charge shall re- egory II must complete 6 supplemental view the content of each such orienta- training units approved by APHIS by tion and shall approve its use after de- the end of their 3-year tenure as an ac- termining that it includes adequate in- credited veterinarian. Accredited vet- formation about animal health agen- erinarians who wish to change the cat- cies, regulatory requirements, adminis- egory in which they are accredited, trative procedures, and animal disease rather than renew accreditation in issues in the new State, to prepare an their current accreditation category, accredited veterinarian from another should follow the procedure in § 161.1(f) State to perform accredited duties in of this part. the new State. The Veterinarian-in- (c) Accredited veterinarians who do Charge shall also give the State Ani- not complete the required training mal Health Official of the new State an within 3 years as specified in paragraph opportunity to review the contents of (a) of this section will have their ac- the orientation, and invite him or her credited status expire. Veterinarians to participate in developing orienta- whose accreditation has expired will tion materials and conducting the ori- not be allowed to perform accredited entation. duties until they receive notification (b) An accredited veterinarian may of their reinstatement from APHIS. not perform accredited duties in a Veterinarians who perform duties that State in which the accredited veteri- only accredited veterinarians are au- narian is not licensed or legally able to thorized to perform while their accred- practice veterinary medicine. ited status has expired will be subject (c) An accredited veterinarian may to such criminal and civil penalties as not perform accredited duties in a are provided by the Animal Health Pro- State other than the one in which the tection Act (7 U.S.C. 8301 et seq.) or veterinarian was initially accredited other applicable Federal statutes or until the veterinarian receives written regulations. To be reinstated, the vet- authorization from APHIS to perform erinarian must complete the necessary accredited duties in the new State. supplemental training units for the ap- (Approved by the Office of Management and propriate category and submit an ap- Budget under control numbers 0579–0032 and plication for renewal of veterinary ac- 0579–0297) creditation to APHIS. A veterinarian [74 FR 65011, Dec. 9, 2009] who allows his or her accredited status to expire must have completed the re- § 161.3 Renewal of accreditation. quired number of supplemental train- (a) Accredited veterinarians who ing units within 3 years of his or her wish to continue participating in the application for renewal in order to be National Veterinary Accreditation approved for renewal. Supplemental Program must renew their accredita- training units completed since the vet- tion every 3 years by completing an ap- erinarian’s last renewal but more than plication for accreditation renewal and 3 years before the veterinarian’s appli- submitting it to APHIS. Newly accred- cation for renewal will not count to- ited veterinarians must renew their ac- wards fulfilling his or her training re- creditation within 3 years of com- quirement. pleting the orientation program de- (d) Veterinarians who are accredited scribed in § 161.1(e)(4) of this part, reas of February 1, 2010, may continue to gardless of when their accreditation perform accredited duties between Feb- was granted. Other veterinarians must ruary 1, 2010, and the date of their first renew their accreditation within 3 renewal. APHIS will provide notice for years of the previous renewal. 3 months to accredited veterinarians (b) Accredited veterinarians who who are accredited as of February 1, wish to renew their accreditation 2010, to notify them that they must under Category I must complete 3 sup- elect to participate in the NVAP as a

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Category I or Category II veterinarian. ence or absence of a communicable dis- Veterinarians must elect to continue ease. to participate by October 1, 2011, or (1) Following the first two inspec- their accredited status will expire. tions of a herd or flock as part of a reg- When APHIS receives notice from an ular health maintenance program, an accredited veterinarian that he or she accredited veterinarian shall not issue elects to participate, APHIS will notify a certificate, form, record or report the accredited veterinarian of his or which reflects the results of any in- her date for first renewal. The accred- spection, test, vaccination or treat- ited veterinarian must then complete ment performed by him or her with re- all the training requirements for respect to any animal in that program, newal, as described in this section, by unless he or she has personally in- his or her first renewal date. spected that animal within 10 days (Approved by the Office of Management and prior to issuance. Budget under control number 0579–0297) (2) Following the third and subse- [74 FR 65011, Dec. 9, 2009, as amended at 76 quent inspections of a herd or flock in FR 52549, Aug. 23, 2011] a regular health maintenance program, an accredited veterinarian shall not § 161.4 Standards for accredited vet- issue a certificate, form, record or re- erinarian duties. port which reflects the results of any An accredited veterinarian shall per- inspection, test, vaccination or treat- form the functions of an accredited ment performed by him or her with re- veterinarian only in a State in which spect to any animal in that program, the accredited veterinarian is licensed unless he or she has personally in- or legally able to practice veterinary spected that animal within 30 days medicine. An accredited veterinarian prior to issuance. shall perform the functions of an ac- (b) An accredited veterinarian shall credited veterinarian and carry out all not issue, or allow to be used, any cer- responsibilities under applicable Fed- tificate, form, record or report, until, eral programs and cooperative pro- and unless, it has been accurately and grams subject to direction provided by fully completed, clearly identifying the the Veterinarian-in-Charge and in ac- animals to which it applies, and show- cordance with any regulations and ining the dates and results of any inspec- structions issued to the accredited vet- tion, test, vaccination, or treatment erinarian by the Veterinarian-in- the accredited veterinarian has con- Charge, and shall observe the following ducted, except as provided in paragraph specific standards: (c) of this section, and the dates of (a) An accredited veterinarian shall not issue a certificate, form, record or issuance and expiration of the docu- report which reflects the results of any ment. Certificates, forms, records, and inspection, test, vaccination or treat- reports shall be valid for 30 days fol- ment performed by him or her with re- lowing the date of inspection of the spect to any animal, other than those animal identified on the document, ex- in regular health maintenance pro- cept that origin health certificates grams, unless he or she has personally may be valid for a longer period of inspected that animal within 10 days time as provided in § 91.3(a) of this prior to issuance. Inspections under chapter. The accredited veterinarian this paragraph must be conducted in a must distribute copies of certificates, location that allows the accredited vet- forms, records, and reports according erinarian sufficient space to observe to instructions issued to him or her by the animal in such a manner as to de- the Veterinarian-in-Charge. tect abnormalities related to areas (c) An accredited veterinarian shall such as, but not limited to, loco- not issue any certificate, form, record, motion, body excretion, respiration, or report which reflects the results of and skin conditions. An accredited vet- any inspection, test, vaccination, or erinarian shall examine such an animal treatment performed by another ac- showing abnormalities, in order to de- credited veterinarian, unless: termine whether or not there is clin- (1) The signing accredited veteri- ical evidence compatible with the pres- narian has exercised reasonable care,

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that is, a standard of care that a rea- municable diseases of animals by the sonably prudent person would use accredited veterinarian. under the circumstances in the course (h) An accredited veterinarian shall of performing professional duties, to keep himself or herself currently in- determine that the certificate, form, or formed on Federal and State regula- report is accurate; tions that are provided to him or her (2) The certificate, form, or report in- by the Veterinarian-in-Charge, or by a dicates that the inspection, test, vac- State official through the Veteri- cination, or treatment was performed narian-in-Charge, governing the move- by the other accredited veterinarian; ment of animals, and on procedures ap- identifies the other accredited veteri- plicable to disease control and eradi- narian by name; and includes the date cation programs, including emergency and the place where such inspection, programs. test, or vaccination was performed; (i) An accredited veterinarian shall and, not use or dispense in any manner, any (3) For a certificate, form, or report pharmaceutical, chemical, vaccine or indicating results of a laboratory test, serum, or other biological product au- the signing accredited veterinarian thorized for use under any Federal reg- shall keep a copy of the certificate, ulation or cooperative disease eradi- form, or report and shall attach to it cation program, in contravention of ap- either a copy of the test results issued plicable Federal or State statutes, reg- by the laboratory, or a written record ulations, and policies. (including date and participants’ (j) An accredited veterinarian shall names) of a conversation between the be responsible for the security and signing accredited veterinarian and the proper use of all official certificates, laboratory confirming the test results. forms, records, and reports; tags, bands, or other identification devices; (d) An accredited veterinarian shall and approved digital signature capa- perform official tests, inspections, bilities used in his or her work as an treatments, and vaccinations and shall accredited veterinarian and shall take submit specimens to designated labora- reasonable care to prevent the misuse tories in accordance with Federal and thereof. An accredited veterinarian State regulations and instructions shall immediately report to the Veteri- issued to the accredited veterinarian narian-in-Charge the loss, theft, or de- by the Veterinarian-in-Charge. liberate or accidental misuse of any (e) An accredited veterinarian shall such certificate, form, record, or re- identify or be physically present to su- port; tag, band, or other identification pervise the identification of reactor device; or approved digital signature animals by tagging or such other meth- capability. od as may be prescribed in instructions (k) An accredited veterinarian may issued to him or her by the Veteri- issue an origin health certificate for narian-in-Charge or by a State Animal export use pursuant to part 91 of this Health Official through the Veteri- chapter without including test results narian-in-Charge. from a laboratory, if the Veterinarian- (f) An accredited veterinarian shall in-Charge has determined that such ac- immediately report to the Veteri- tion is necessary to save time in order narian-in-Charge and the State Animal to meet an exportation schedule and Health Official all diagnosed or sus- agrees to add the test results to the pected cases of a communicable animal certificate at a later time. In such disease for which a APHIS has a con- cases, the accredited veterinarian shall trol or eradication program in 9 CFR state on a removable attachment to chapter I, and all diagnosed or sus- the certificate that such test results pected cases of any animal disease not are to be added by the Veterinarian-in- known to exist in the United States as Charge. provided by § 71.3(b) of this chapter. [57 FR 54912, Nov. 23, 1992; 58 FR 8820, Feb. 17, (g) While performing accredited 1993; 60 FR 39842, Aug. 4, 1995; 60 FR 55443, work, an accredited veterinarian shall Nov. 1, 1995; 62 FR 25445, May 9, 1997; 67 FR take such measures of sanitation as are 11561, Mar. 15, 2002. Redesignated at 74 FR necessary to prevent the spread of com- 65011, Dec. 9, 2009]

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§ 161.5 Program certifications. ited veterinarians are authorized to A program certification recognized perform while their accredited status is by the Administrator may be granted suspended or revoked will be subject to to an accredited veterinarian in Cat- such criminal and civil penalties as are egory II upon completion of an addi- provided by the Animal Health Protec- tional orientation or training program tion Act (7 U.S.C. 8301 et seq.) or other approved by APHIS that focuses on the applicable Federal statutes or regula- specific area for which the veterinarian tions. Performing accredited duties is seeking program certification. Vet- while accreditation status is suspended erinarians accredited under Category I or revoked will be considered grounds are not eligible to earn program cer- for the Administrator to suspend ac- tifications. Accredited veterinarians creditation, revoke accreditation, or may elect to participate in a program deny application for reaccreditation, as certification on a voluntary basis. Par- circumstances warrant. A veterinarian ticipants in these program certifi- whose accreditation has been sus- cations will be qualified in a particular pended or revoked or whose application area or specialty. In addition to Cat- for reaccreditation has been denied egory II training, qualification for a may request a hearing under § 162.13 to program certification will include addi- challenge the Administrator’s decision. tional specialized training, which may (b) Reinstatement after suspension. A include periodic training updates. For veterinarian whose accreditation has certain program certifications, the cost of orientation or training may be been suspended for less than 6 months borne by the accredited veterinarian. (other than a summary suspension that An accredited veterinarian granted a is changed to a revocation as a result program certification will be referred of an adjudicatory proceeding) will be to as a qualified accredited veteri- automatically reinstated as an accred- narian or QAV. A QAV will be author- ited veterinarian upon completion of ized to perform those accredited duties the suspension. A veterinarian whose related to the program certification he accreditation has been suspended for 6 or she has earned; accredited veterinar- months or more must complete a re- ians not granted program certifications accreditation orientation program in will not be permitted to perform ac- accordance with paragraph (c)(2)(ii) of credited duties related to that par- this section before accreditation will ticular program certification. If a QAV be reinstated. allows his or her Category II accredita- (c) Reaccreditation after revocation. A tion to expire, the QAV’s program cer- veterinarian whose accreditation has tification expires as well, and the QAV been revoked may apply for reaccredi- must be qualified for the program cer- tation by completing an application for tification again in accordance with this reaccreditation and submitting it to section. the Veterinarian-in-Charge of the [74 FR 65012, Dec. 9, 2009] State or area where he or she wishes to perform accredited work. The applica- § 161.6 Suspension or revocation of tion may be submitted when the rev- veterinary accreditation and reaccreditation; criminal and civil ocation has been in effect for not less penalties. than 2 years, unless the revocation order specifies that the veterinarian (a) The Administrator is authorized whose accreditation has been revoked to suspend for a given period of time, or to revoke, the accreditation of a vet- may not submit an application for re- erinarian when he or she determines accreditation until the revocation has that the accredited veterinarian has been in effect for a period of time not complied with the ‘‘Standards for longer than 2 years. Accredited Veterinarian Duties’’ as set (1) Completed applications for re- forth in § 161.4 of this part or with any accreditation received by a Veteri- of the other regulations in this sub- narian-in-Charge shall be reviewed by chapter, or is otherwise found to be the State Animal Health Official for unfit to be accredited. Veterinarians the State in which the veterinarian who perform duties that only accred- wishes to perform accredited duties.

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Within 14 days after receiving an appli- making this conclusion, the Adminis- cation, the State Animal Health Offi- trator shall review all available infor- cial shall either endorse the applica- mation about the applicant, including tion or send a written statement to the recommendations of the State Animal Administrator explaining why it was Health Official, and shall consider: not endorsed; but if the State Animal (A) Any criminal conviction records Health Official fails to take one of indicating that the applicant may lack these actions within 14 days, the Vet- the honesty, integrity, and reliability erinarian-in-Charge shall proceed to re- to appropriately and effectively per- view the application. The Adminis- form accredited duties and to uphold trator will review the application and the integrity of the National Veteri- the written statement, if any, and de- nary Accreditation Program; termine whether the applicant meets (B) Official records of the applicant’s the requirements for reaccreditation actions participating in Federal, State, contained in this part. or local veterinary programs; (2) Once a veterinarian whose accred- (C) Judicial determinations in civil itation has been revoked has correctly litigation adversely reflecting on the applied for reaccreditation in accord- honesty, integrity, and reliability of ance with the requirements of para- the applicant; and graph (c) of this section, the Adminis- (D) Any other evidence reflecting on trator will determine whether to re- the honesty, professional integrity, re- accredit or to deny reaccreditation. liability and reputation of the appli- This determination will be based on cant. whether the veterinarian has fulfilled (3)(i) If a veterinarian is reaccredited the following conditions: under paragraph (c)(2) of this section, (i) The veterinarian is licensed or le- the veterinarian may begin performing gally able to practice veterinary medi- accredited duties again upon receipt of cine in the State in which the veteri- notification from the Administrator narian wishes to perform accredited that he or she is eligible to do so. duties; (ii) If an application for reaccredita- (ii) The veterinarian has completed a tion is denied under paragraph (c)(2) of reaccreditation orientation program this section, the veterinarian may approved by the Veterinarian-in- apply for reaccreditation in accordance Charge for the State in which the vet- with this paragraph (c) not less than 2 erinarian wishes to perform accredited years after the application was last de- work, and upon completion of the ori- nied, unless the decision specifies that entation, has signed a written state- the veterinarian may not reapply for ment listing the date and place of ori- reaccreditation until a period of time entation, the subjects covered in the longer than 2 years has passed. orientation, and any written materials (d) Accreditation shall be automati- provided to the veterinarian at the ori- cally terminated when an accredited entation. The Veterinarian-in-Charge veterinarian is not licensed or legally shall also give the State Animal Health able to practice veterinary medicine in Official an opportunity to review the at least one State. contents of the reaccreditation ori- (e) Accreditation shall be automati- entation, and invite him or her to par- cally revoked when an accredited vet- ticipate in developing orientation ma- erinarian is convicted of a crime in ei- terials and conducting the orientation. ther State or Federal court, if such The orientation program shall include conviction is based on the performance topics addressing the subject areas or nonperformance of any act required which led to loss of accreditation for of the veterinarian in his or her capac- the applicant, and subject areas which ity as an accredited veterinarian. have changed since the applicant lost (f) Any accredited veterinarian who accreditation; and knowingly issues or signs a false, in- (iii) The professional integrity and correct, or mislabeled animal health or reputation of the applicant support a inspection certificate, blood sample, of- conclusion that the applicant will ficial brucellosis vaccination certifi- faithfully fulfill the duties of an ac- cate, or official tuberculin test certifi- credited veterinarian in the future. In cate in accordance with this chapter,

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shall be subject to such civil penalties Subpart B—Supplemental Rules of Practice and such criminal liabilities as are pro- 162.10 Summary suspension or revocation of vided by 7 U.S.C. 8313, 18 U.S.C. 1001, or accreditation of veterinarians. other applicable Federal statutes. Such 162.11 Notification. action may be in addition to, or in lieu 162.12 Informal conference. of, suspension or revocation of accred- 162.13 Formal complaint. ited veterinarian status in accordance AUTHORITY: 7 U.S.C. 8301–8317; 15 U.S.C. with this section. 1828; 7 CFR 2.22, 2.80, and 371.4. (g) Notice of warning. In lieu of sus- SOURCE: 57 FR 54915, Nov. 23, 1992, unless pension or revocation, the Adminis- otherwise noted. trator is authorized to issue a written notice of warning to an accredited vet- Subpart A—General erinarian when the Administrator determines a notice of warning will be § 162.1 Scope and applicability of rules adequate to attain compliance with the of practice. Standards for Accredited Veterinarian The Uniform Rules of Practice for Duties in § 161.4 of this part. the Department of Agriculture promul- [57 FR 54912, Nov. 23, 1992, as amended at 68 gated in subpart H of part 1, subtitle A, FR 6346, Feb. 7, 2003. Redesignated and title 7, Code of Federal Regulations, amended at 74 FR 65011, 65012, Dec. 9, 2009] are the Rules of Practice applicable to adjudicatory, administrative pro- § 161.7 Activities performed by non-ac- ceedings for the revocation or suspen- credited veterinarians. sion of accreditation of veterinarians (9 (a) Full-time Federal (including mili- CFR parts 160 and 161). In addition, the tary) and State employed veterinarians Supplemental Rules of Practice set forth in subpart B of this part shall be are authorized to perform functions applicable to such proceedings. specified in subchapters B, C, and D of this chapter, pursuant to delegation of authority by the Administrator or co- Subpart B—Supplemental Rules of operative agreements, without specific Practice accreditation under the provisions of § 162.10 Summary suspension or rev- this subchapter. ocation of accreditation of veteri- (b) Except as provided by paragraph narians. (a) of this section, anyone who per- In any situation where the Adminis- forms accredited veterinarian duties trator has reason to believe that any that he or she is not authorized to per- veterinarian accredited under the pro- form will be subject to such criminal visions of parts 160 and 161 of this sub- and civil penalties as are provided by chapter has knowingly violated the the Animal Health Protection Act (7 Animal Health Protection Act (7 U.S.C. U.S.C. 8301 et seq.) or other applicable 8301 et seq.), the Administrator may Federal statutes or regulations. Per- summarily suspend the accreditation forming accredited duties without hav- of such veterinarian pending final de- ing been accredited will be considered termination in either a suspension or grounds for the Administrator to deny revocation proceeding, effective upon an application for accreditation. oral or written notification, whichever [74 FR 65013, Dec. 9, 2009] is earlier. In the event of oral notification, a written confirmation thereof shall be given to such veterinarian as PART 162—RULES OF PRACTICE promptly as circumstances permit. GOVERNING REVOCATION OR SUSPENSION OF VETERINARIANS’ [74 FR 65013, Dec. 9, 2009] ACCREDITATION § 162.11 Notification. The Veterinarian-in-Charge shall no- Subpart A—General tify an accredited veterinarian when Sec. there is reason to believe that the ac- 162.1 Scope and applicability of rules of credited veterinarian has not complied practice. with the ‘‘Standards for Accredited

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Veterinarian Duties’’ as contained in credited veterinarian is found not to § 161.4 of this subchapter. The notifica- have violated the regulations, the Vet- tion shall be in writing, with a copy to erinarian-in-Charge will issue a letter the State Animal Health Official, and dismissing the case, and provide a copy shall include a statement of the basis of the letter to the accredited veteri- for the belief that the accredited vet- narian and to the State Animal Health erinarian has failed to comply with the Official. Prior to, during, or after the Standards and shall notify the accred- informal conference, the Veterinarian- ited veterinarian if the Veterinarian- in-Charge may issue a letter identi- in-Charge has arranged to hold an in- fying actions of the accredited veteri- formal conference to discuss the mat- narian that were minor violations of ter. the Standards, instructing the accredited veterinarian in proper procedures, [57 FR 54915, Nov. 23, 1992, as amended at 75 FR 57658, Sept. 22, 2010] and admonishing the accredited veterinarian to use greater care in per- § 162.12 Informal conference. forming these procedures in the future. (a) The Veterinarian-in-Charge, in (c) Prior to, during, or at the conclu- consultation with the State Animal sion of the informal conference, the Health Official and the accredited vet- Veterinarian-in-Charge may issue a erinarian, shall designate the time and written warning to the accredited vet- place for the holding of an informal erinarian without further procedure conference to review the matter, unless after determining that a warning with the Veterinarian-in-Charge determines appropriate instructions will be ade- that an informal conference is inappro- quate to attain compliance with the priate. An informal conference is inap- Standards. propriate only if the Veterinarian-in- (d) If prior to, during, or at the con- Charge decides to dismiss the case clusion of, the informal conference, the based on available facts, or if civil or accredited veterinarian consents, in criminal charges based on the actions writing, to the issuance of an order re- or inactions believed to be in violation voking or suspending his or her accred- of the ‘‘Standards for Accredited Vet- itation for a specified period of time, in erinarian Duties’’ contained in § 161.4 of lieu of further procedure, the Veteri- this subchapter are pending against the narian-in-Charge may issue such a con- accredited veterinarian. An informal sent order without further procedure. conference shall include the Veteri- [57 FR 54915, Nov. 23, 1992; 57 FR 60086, Dec. narian-in-Charge or his or her rep- 18, 1992, as amended at 74 FR 65013, Dec. 9, resentative, the accredited veteri- 2009; 75 FR 57659, Sept. 22, 2010] narian, and any other persons the Vet- erinarian-in-Charge requests to attend § 162.13 Formal complaint. due to their involvement in or knowl- If a consent order has not been edge of the possible violation. The issued, or if, after an informal con- State Animal Health Official will be in- ference, the Veterinarian-in-Charge vited to attend each informal con- has not issued a letter of dismissal or ference held regarding activities in his letter of warning to the accredited vet- or her State. erinarian, a formal complaint may be (b) If prior to, during, or after the in- issued by the Administrator in accord- formal conference, but prior to the ance with § 1.135 of the Uniform Rules issuance of a formal complaint, the ac- of Practice (7 CFR 1.135).

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PART 165—AVAILABILITY OF lic and disclosure of records under 5 INFORMATION U.S.C. 552, which are set forth in 7 CFR part 370, are incorporated into this sub- § 165.1 Availability of information. chapter. The Animal and Plant Health Inspec- (5 U.S.C. 552, 559) tion Service regulations relating to [32 FR 10915, July 26, 1967, as amended at 36 availability of information to the pub- FR 24928, Dec. 24, 1971]

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PART 166—SWINE HEALTH Animals. All domesticated and wild PROTECTION mammalian, poultry, and fish species, and wild and domesticated animals, including pets such as dogs and cats. GENERAL PROVISIONS Area Veterinarian in Charge. The vet- Sec. erinarian of APHIS who is assigned by 166.1 Definitions in alphabetical order. the Administrator to supervise and 166.2 General restrictions. perform the official work of APHIS in 166.3 Separation of swine from the garbage handling and treatment areas. a State or States or any other official 166.4 Storage of garbage. to whom authority has heretofore been 166.5 Licensed garbage-treatment facility delegated or to whom authority may standards. hereafter be delegated to act in his 166.6 Swine feeding area standards. stead. 166.7 Cooking standards. Facility. The site and all objects at 166.8 Vehicles used to transport garbage. this site including equipment and 166.9 Recordkeeping. structures where garbage is accumu- 166.10 Licensing. lated, stored, handled, and cooked as a 166.11 Suspension and revocation of licenses. food for swine and which are fenced in 166.12 Cancellation of licenses. or otherwise constructed so that swine 166.13 Licensee responsibilities. are unable to have access to untreated 166.14 Cleaning and disinfecting. garbage. 166.15 State status. Garbage. All waste material derived AUTHORITY: 7 U.S.C. 3801–3813; 7 CFR 2.22, in whole or in part from the meat of 2.8, and 371.4 any animal (including fish and poultry) or other animal material, and other SOURCE: 47 FR 49945, Nov. 3, 1982, unless refuse of any character whatsoever otherwise noted. that has been associated with any such GENERAL PROVISIONS material, resulting from the handling, preparation, cooking or consumption of § 166.1 Definitions in alphabetical food, except that such term shall not order. include waste from ordinary household For the purposes of this part, the fol- operations which is fed directly to lowing terms shall have the meanings swine on the same premises where such assigned them in this section. Unless household is located. otherwise required by the context, the Inspector. Any individual employed singular form shall also import the plu- by the United States Department of ral and the masculine form shall also Agriculture or by a State for the pur- import the feminine, and vice versa. poses of enforcing the Act and this Words undefined in the following para- part. graphs shall have the meaning attrib- License. A permit issued to a person uted to them in general usage as refor the purpose of allowing such person flected by definitions in a standard dic- to operate a facility to treat garbage tionary. that is to be fed to swine. Act. The Swine Health Protection Licensee. Any person licensed pursu- Act (Pub. L. 96–468) as amended by the ant to the Act and regulations. Farm Credit Act Amendments of 1980 Person. Any individual, corporation, (Pub. L. 96–592). company, association, firm, partner- Administrator. The Administrator, ship, society or joint stock company or Animal and Plant Health Inspection other legal entity. Service, or any person authorized to Premises. The location of a garbage act for the Administrator. treatment facility, as defined in this Animal and Plant Health Inspection part, and any areas owned or con- Service (APHIS). The Animal and Plant trolled by the operator of the facility Health Inspection Service of the United where swine are kept or fed by the op- States Department of Agriculture. erator.

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Processed product. Material derived in § 166.2 General restrictions. whole or in part from the meat of any (a) No person shall feed or permit the animal (including fish and poultry) or feeding of garbage to swine unless the other animal material, and other garbage is treated to kill disease orga- refuse of any character whatsoever nisms, pursuant to this part, at a facil- that has been associated with any such ity operated by a person holding a material, that has undergone an indus- valid license for the treatment of gar- trial manufacturing procedure to pre- bage; except that the treatment and li- vent spoilage or add shelf stability, and cense requirements shall not apply to that has, at a minimum, been cooked the feeding or the permitting of the ° ° to a temperature of 167 F (75 C) for at feeding to swine of garbage only be- least 30 minutes or has been subjected cause the garbage consists of any of to an industrial process demonstrated the following: Processed products; ren- to provide an equivalent level of inac- dered products; bakery waste; candy tivation of disease organisms, as ap- waste; eggs; domestic dairy products proved by the Administrator. (including milk); fish from the Atlantic Rendered product. Waste material de- Ocean within 200 miles of the conti- rived in whole or in part from the meat nental United States or Canada; or fish of any animal (including fish and poul- from inland waters of the United try) or other animal material, and States or Canada which do not flow other refuse of any character whatso- into the Pacific Ocean. ever that has been associated with any (b) No person operating such a facil- such material, resulting from the han- ity may be licensed to treat garbage dling, preparation, cooking or con- unless he or she meets the require- sumption of food that has been ground ments of this part designed to prevent and heated to a minimum temperature the introduction or dissemination of of 230 °F. to make products such as, but any infectious or communicable dis- not limited to, animal, poultry, or fish ease of animals and unless the facility protein meal, grease or tallow. is so constructed that swine are unable State. The fifty States, the District of to have access to untreated garbage or Columbia, Guam, Puerto Rico, the Vir- equipment and material coming in con- gin Islands of the United States, Amer- tact with untreated garbage. ican Samoa, the Commonwealth of the (c) The regulations of this part shall Northern Mariana Islands, and the ter- not be construed to repeal or supersede ritories and possessions of the United State laws that prohibit feeding of gar- States. bage to swine or to prohibit any State State animal health official. The indi- from enforcing requirements relating vidual employed by a State who is re- to the treatment of garbage that is to sponsible for livestock and poultry dis- be fed to swine or the feeding thereof ease control and eradication programs which are more stringent than the re- or any other official to whom author- quirements contained in this part. In a ity is delegated to act for the State State which prohibits the feeding of animal health official. garbage to swine, a license under the Treated garbage. Edible waste for ani- Act will not be issued to any applicant. mal consumption derived from garbage (as defined in this section) that has [47 FR 49945, Nov. 3, 1982, as amended at 49 FR 14497, Apr. 12, 1984; 52 FR 4890, Feb. 18, been heated throughout at boiling or 1987; 66 FR 21064, Apr. 27, 2001; 74 FR 15218, equivalent temperature (212 °F. or 100 Apr. 3, 2009] °C. at sea level) for 30 (thirty) minutes under the supervision of a licensee. § 166.3 Separation of swine from the Treatment. The heating of garbage to garbage handling and treatment specifications as set forth in this part. areas. Untreated garbage. Garbage that has (a) Access by swine to garbage han- not been treated in accordance with dling and treatment areas shall be pre- the Act and these regulations. vented by construction of facilities to [47 FR 49945, Nov. 3, 1982, as amended at 48 exclude all ages and sizes of swine. FR 22290, May 18, 1983; 52 FR 4890, Feb. 18, (b) All areas and drainage therefrom, 1987; 56 FR 26899, June 12, 1991; 66 FR 21064, used for the handling and treatment of Apr. 27, 2001; 74 FR 15218, Apr. 3, 2009] untreated garbage shall be inaccessible

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to swine on the premises. This shall in- cleaned and disinfected as set forth in clude the roads and areas used to § 166.14(b) of this part. transport and handle untreated gar- [47 FR 49945, Nov. 3, 1982, as amended at 52 bage on the premises. FR 4890, Feb. 18, 1987]

§ 166.4 Storage of garbage. § 166.7 Cooking standards. (a) Untreated garbage at a treatment (a) Garbage shall be heated through- facility shall be stored in covered and out at boiling (212 °F. or 100 °C. at sea leakproof containers until treated. level) for 30 (thirty) minutes. (b) Treated garbage shall be trans- (b) Garbage shall be agitated during ported to a feeding area from the treat- cooking, except in steam cooking ment facility only in (1) containers equipment, to ensure that the pre- used only for such treated garbage; (2) scribed cooking temperature is main- containers previously used for garbage tained throughout the cooking con- which have been cleaned and dis- tainer for the prescribed length of infected in accordance with § 166.14 of time. this part; or (3) containers in which the garbage was treated. § 166.8 Vehicles used to transport garbage. [47 FR 49945, Nov. 3, 1982, as amended at 52 FR 4890, Feb. 18, 1987] Vehicles used by a licensee to transport untreated garbage, except those § 166.5 Licensed garbage-treatment fa- that have also been used to treat the cility standards. garbage so moved, shall not be used for hauling animals or treated garbage Garbage-treatment facilities shall be until cleaned and disinfected as set maintained as set forth in this section. forth in § 166.14(c) of this part. (a) Insects and animals shall be controlled. Accumulation of any material [47 FR 49945, Nov. 3, 1982, as amended at 52 at the facility where insects and ro- FR 4890, Feb. 18, 1987] dents may breed is prohibited. § 166.9 Recordkeeping. (b) Equipment used for handling untreated garbage, except for the con- (a) Each licensee shall record the des- tainers in which the garbage has been tination and date of removal of all treated, may not be subsequently used treated or untreated garbage removed in the feeding of swine unless first from the licensee’s premises. cleaned and disinfected as set forth in (b) Such records shall be legible and § 166.14(b). indelible. (c) Untreated garbage that is not to (c) Each entry in a record shall be be fed to swine and materials in asso- certified as correct by initials or signa- ciation with such garbage shall be dis- ture of the licensee or an authorized agent or employee of the licensee. posed of in a manner consistent with all applicable governmental environ- (d) Such records shall be maintained by the licensee for a period of 1 year mental regulations and in an area inac- from the date made and shall be made cessible to swine. available to inspectors upon request [47 FR 49945, Nov. 3, 1982, as amended at 52 during normal business hours at that FR 4890, Feb. 18, 1987] treatment facility.

§ 166.6 Swine feeding area standards. (Approved by the Office of Management and Budget under control number 0579–0066) Untreated garbage shall not be al- [47 FR 49945, Nov. 3, 1982, as amended at 48 lowed into swine feeding areas. Any FR 57474, Dec. 30, 1983; 52 FR 4890, Feb. 18, equipment or material associated with 1987] untreated garbage, except for containers holding treated garbage which § 166.10 Licensing. was treated in such containers, shall (a) Application. Any person operating not be allowed into swine feeding areas or desiring to operate a treatment fa- at treatment premises until properly cility for garbage that is to be treated

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and fed to swine shall apply for a li- (3) The facilities and equipment of an cense on a form which will be fur- applicant for a license shall be in com- nished, upon request, by the Area Vet- pliance with all applicable govern- erinarian in Charge or, in States with mental environmental regulations be- primary enforcement responsibility, by fore the applicant will be licensed. the State animal health official in the (d) Issuance of license. A license will State in which the person operates or be issued to an applicant when the re- intends to operate. When a person oper- quirements of paragraphs (a), (b), and ates more than one treatment facility, (c) of this section have been met, pro- a separate application to be licensed vided that such facility is not located shall be made for each facility. Exemp- in a State which prohibits the feeding tions to the requirements of this para- of garbage to swine; and further, that if graph may be granted in States other the Administrator has reason to be- than those with primary enforcement lieve that the applicant for a license is unfit to engage in the activity for responsibility by the Administrator, if which application has been made by he finds that there would not be a risk reason of the fact that the applicant is to the swine industry in the United engaging in or has, in the past, engaged States. Any person operating or desir- in any activity in apparent violation of ing to operate a facility to treat gar- the Act or the regulations which has bage to be fed to swine who would oth- not been the subject of an administra- erwise be required under this part to tive proceeding under the Act, an ad- obtain a license to treat garbage only ministrative proceeding shall be because it contains one or more of the promptly instituted in which the appli- items allowed to be fed to swine under cant will be afforded an opportunity for § 166.2(a) of this part is exempted from a hearing in accordance with the rules the requirements of this paragraph. of practice under the Act, for the pur- (b) Acknowledgement of Act and regula- pose of giving the applicant an oppor- tions. A copy of the Act and regulations tunity to show cause why the applica- shall be supplied to the applicant at tion for license should not be denied. In the time the applicant is given a li- the event it is determined that the ap- cense application. The applicant shall plication should be denied, the appli- sign a receipt at the time of the cant shall be precluded from re- prelicensing inspection acknowledging applying for a license for 1 year from that the applicant has received a copy the date of the order denying the appli- of the Act and regulations, that the ap- cation. plicant understands them, and agrees to comply with the Act and regula- (Approved by the Office of Management and Budget under control number 0579–0065) tions. (c) Demonstration of compliance with [47 FR 49945, Nov. 3, 1982, as amended at 48 the regulations. (1) Prior to licensing, FR 57474, Dec. 30, 1983; 49 FR 14497, Apr. 12, 1984; 52 FR 4890, Feb. 18, 1987; 56 FR 26899, each applicant shall demonstrate dur- June 12, 1991; 66 FR 21064, Apr. 27, 2001] ing an inspection of the premises, facilities, and equipment that the facili- § 166.11 Suspension and revocation of ties and equipment to be used in the licenses. treatment of garbage comply with (a) Suspension or revocation after no- these regulations. If the applicant’s fa- tice. In addition to the imposition of cilities and equipment do not meet the civil penalties and the issuance of standards established by the regula- cease and desist orders under the Act, tions, the applicant shall not be li- the license of any facility may be sus- censed and shall be advised of the defi- pended or revoked for any violation of ciencies and the measures that must be the Act or the regulations in this part. taken to comply with the regulations. Before such action is taken, the li- (2) The licensee shall make the prem- censee of the facility will be informed ises, facilities, and equipment available in writing of the reasons for the pro- during normal business hours for in- posed action and, upon request, shall spections by an inspector to determine be afforded an opportunity for a hear- continuing compliance with the Act ing with respect to the merits or valid- and regulations. ity of such action, in accordance with

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rules of practice which shall be adopted § 166.12 Cancellation of licenses. for the proceeding. (a) The Area Veterinarian in Charge (b) Summary suspension. If the Admin- or, in States listed in § 166.15(d) of this istrator has reason to believe that any part, the State animal health official licensee has not complied or is not shall cancel the license of a licensee complying with any provisions of the when the Area Veterinarian in Charge Act or regulations in this part and the or, in States listed in § 166.15(d) of this Administrator deems such action nec- part, the State animal health official essary in order to protect the public finds that no garbage has been treated health, interest, or safety, the Admin- for a period of 4 consecutive months at istrator may summarily suspend the li- the facility operated by the licensee. cense of such persons pending a final Before such action is taken, the li- determination in formal proceedings censee of the facility will be informed and any judicial review thereof, effec- in writing of the reasons for the pro- tive upon verbal or written notice of posed action and be given an oppor- such suspension and the reasons there- tunity to respond in writing. In those instances where there is a conflict as for. In the event of verbal notification, to the facts, the licensee shall, upon rewritten confirmation shall follow as quest, be afforded a hearing in accord- soon as circumstances permit. This ance with rules of practice which shall summary suspension shall continue in be adopted for the proceeding. effect pending the completion of the (b) Any licensee may voluntarily proceeding and any judicial review have his or her license canceled by re- thereof, unless otherwise ordered by questing such cancellation in writing the Administrator. and sending such request to the Area (c) The license of a person shall be Veterinarian in Charge, 1 or, in States automatically revoked, without action listed in § 166.15(d) of this part, to the of the Administrator, upon the final ef- State animal health official. The Area fective date of the second criminal con- Veterinarian in Charge or, in States viction of such person, as is stated in listed in § 166.15(d) of this part, the section 5(c) of the Act. The licensee State animal health official shall can- will be notified in writing of such rev- cel such license and shall notify the li- ocation by the Area Veterinarian in censee of the cancellation in writing. (c) Any person whose license is can- Charge or, in States having primary celed in accordance with paragraph (a) enforcement responsibility, by the or (b) of this section may apply for a State animal health official. new license at any time by following (d) Any person whose license has the procedure for obtaining a license been suspended or revoked for any rea- set forth in § 166.10 of this part. son shall not be licensed in such person’s own name or in any other man- [52 FR 4891, Feb. 18, 1987, as amended at 56 FR 26899, June 12, 1991; 59 FR 67618, Dec. 30, ner, nor shall any of such person’s em- 1994] ployees be licensed for the purpose of operating the facility owned or oper- § 166.13 Licensee responsibilities. ated by said licensee while the order of (a) A licensed facility shall be subject suspension or revocation is in effect. to inspections. Each inspector will be Any person whose license has been re- furnished with an official badge or voked shall not be eligible to apply for identification card, either of which a new license for a period of 1 year shall be sufficient identification to en- from the effective date of such revoca- title access during normal business tion. Any person who desires the rein- hours to the facility for the purposes of statement of a license that has been re- inspection. At such time the inspector voked must follow the procedure for is duly authorized to: new licensees set forth in § 166.10 of this part. 1 The name and address of the Area Veteri- narian in Charge may be obtained from the [47 FR 49945, Nov. 3, 1982, as amended at 52 Veterinary Services, Operational Support, FR 4890, Feb. 18, 1987; 56 FR 26899, June 12, 4700 River Road, Unit 33, Riverdale, Mary- 1991] land 20737–1231.

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(1) Inspect the facility, including claims and labeled as efficacious cooker function; against any species within the viral (2) Take samples of garbage; genus Herpes, that are used for pur- (3) Observe and physically inspect the poses of this Part in accordance with health status of all species of animals directions on the EPA-approved label. on the premises; (b) All premises at which garbage has (4) Review records and make copies of been fed to swine in violation of the such records; and Act or regulations in this part shall, (5) Take photographs. A copy of each prior to continued use for swine feeding photograph will be provided to the li- purposes, be cleaned and disinfected censee within 14 days. under the supervision of an inspector (b) A licensee shall notify an inspec- or an accredited veterinarian as de- tor immediately upon detection of ill- fined in Part 160 of this chapter as fol- ness or death not normally associated lows: Empty all troughs and other feed- with the licensee’s operation in any ing and watering appliances, remove animal species on the licensee’s prem- all litter, garbage, manure, and other ises. organic material from the floors, posts, (c) A licensee shall notify an inspec- or other parts of such equipment, and tor or the State animal health official handle such litter, garbage, manure, or the Area Veterinarian in Charge, as and other organic material in such appropriate, of any change in the manner as not to allow animal contact name, address, management or sub- with such material; clean all surfaces stantial control or ownership of his with water and detergent and saturate business or operation within 30 days the entire surface of the equipment, after making such change. fencing, troughs, chutes, floors, walls, (d) A licensee shall supply, upon re- and all other parts of the facilities, quest by an inspector, information con- with a disinfectant prescribed in para- cerning sources of garbage. Such infor- graph (a) of this section. An exemption mation shall include the dates of sup- to the requirements of this paragraph ply and the names and addresses of the may be given by the Administrator or, person and/or organization from which in States with primary enforcement re- the garbage was received. sponsibility, by the State animal (Approved by the Office of Management and health official, when it is determined Budget under control number 0579–0065) that a threat to the swine industry [47 FR 49945, Nov. 3, 1982, as amended at 48 does not exist. FR 57474, Dec. 30, 1983; 52 FR 4890, Feb. 18, (c) Any vehicle or other means of 1987. Redesignated at 52 FR 4891, Feb. 18, conveyance and its associated equip- 1987] ment which has been used by the licensee to move garbage, except any ve- § 166.14 Cleaning and disinfecting. hicle or other means of conveyance (a) Disinfectants to be used. Disinfec- which also has been used to treat the tion required under the regulations in garbage so moved, shall, prior to use this Part shall be performed with one for livestock-related or treated garbage of the following: hauling purposes, be cleaned and dis- (1) A permitted brand of sodium infected as follows: Remove all litter, orthophenylphenate that is used in ac- garbage, manure, and other organic cordance with directions on the Envi- material from all portions of each ronmental Protection Agency (EPA) means of conveyance, including all approved label. ledges and framework inside and out- (2) A permitted cresylic disinfectant side, and handle such litter, garbage, that is used in accordance with direc- manure, and other organic material in tions on the EPA-approved label, pro- such manner as not to allow animal vided such disinfectant also meets the contact with such material; clean the requirements set forth in §§ 71.10(b) and interior and the exterior of such vehi- 71.11 of this chapter. cle or other means of conveyance and (3) Distinfectants which are reg- its associated equipment with water istered under the Federal Insecticide, and detergent; and saturate the entire Fungicide, and Rodenticide Act (7 interior surface, including all doors, U.S.C. 136 et seq.), with tuberculocidal endgates, portable chutes, and similar

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equipment with a disinfectant pre- ices, Swine Health, 4700 River Road, scribed in paragraph (a) of this section. Unit 37, Riverdale, Maryland 20737–1231, (d) The owner of such facilities and concerning the feeding of garbage to vehicles shall be responsible for clean- swine. ing and disinfecting as required under [47 FR 49945, Nov. 3, 1982. Redesignated at 52 this section, and the cleaning and dis- FR 4891, Feb. 18, 1987] infecting shall be done without expense to the United States Department of EDITORIAL NOTE: For FEDERAL REGISTER ci- Agriculture. tations affecting § 166.15, see the List of CFR Sections Affected, which appears in the [47 FR 49945, Nov. 3, 1982. Redesignated and Finding Aids section of the printed volume amended at 52 FR 4891, Feb. 18, 1987; 56 FR and at www.fdsys.gov. 26899, June 12, 1991; 68 FR 6346, Feb. 7, 2003] PART 167—RULES OF PRACTICE § 166.15 State status. GOVERNING PROCEEDINGS (a) The following States prohibit the UNDER THE SWINE HEALTH PRO- feeding of garbage to swine: Alabama, TECTION ACT Delaware, Georgia, Idaho, Illinois, Indi- ana, Iowa, Kansas, Kentucky, Lou- Subpart A—General isiana, Mississippi, Nebraska, New York, North Dakota, Oregon, South Sec. Carolina, South Dakota, Tennessee, 167.1 Scope and applicability of rules of Virginia, and Wisconsin. practice. (b) The following States and Puerto Rico permit the feeding of treated gar- Subpart B—Supplemental Rules of Practice bage to swine: Alaska, Arizona, Arkan- 167.10 Stipulations. sas, California, Colorado, Connecticut, AUTHORITY: 7 U.S.C. 3804, 3805, and 3811; 7 Florida, Hawaii, Maine, Maryland, CFR 2.22, 2.80, and 371.4. Massachusetts, Michigan, Minnesota, Missouri, Montana, Nevada, New SOURCE: 48 FR 30095, June 30, 1983, unless otherwise noted. Hampshire, New Jersey, New Mexico, North Carolina, Ohio, Oklahoma, Penn- sylvania, Puerto Rico, Rhode Island, Subpart A—General Texas, Utah, Vermont, Washington, § 167.1 Scope and applicability of rules West Virginia, and Wyoming. of practice. (c) The following States have primary enforcement responsibility under The Uniform Rules of Practice for the Act: Alabama, Arizona, California, the Department of Agriculture promul- Colorado, Florida, Georgia, Hawaii, gated in subpart H of part 1, subtitle A, Idaho, Illinois, Indiana, Iowa, Michi- title 7, Code of Federal Regulations, gan, Minnesota, Mississippi, Missouri, are the Rules of Practice applicable to Montana, Nebraska, Nevada, New Jer- adjudicatory, administrative pro- sey, New York, North Dakota, Ohio, ceedings under sections 5 and 6 of the Pennsylvania, South Carolina, South Swine Health Protection Act (7 U.S.C. Dakota, Tennessee, Utah, Virginia, 3804, 3805). In addition, the Supple- West Virginia, and Wisconsin. mental Rules of Practice set forth in (d) The following States issue li- subpart B of this part shall be applica- censes under cooperative agreements ble to such proceedings. with the Animal and Plant Health In- spection Service, but do not have pri- Subpart B—Supplemental Rules of mary enforcement responsibility under Practice the Act: Maryland, Puerto Rico, Texas, and Washington. § 167.10 Stipulations. (e) The public may contact the Area (a) At any time prior to the issuance Veterinarian in Charge, Animal and of a complaint seeking a civil penalty Plant Health Inspection Service, under the Act, the Administrator, in United States Department of his discretion, may enter into a stipu- Agiculture or State animal health offi- lation with any person in which: cial, or the Animal and Plant Health (1) The Administrator or the Admin- Inspection Service, Veterinary Serv- istrator’s delegate gives notice of an

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apparent violation of the Act, or the ticular matter conditioned upon timely regulations issued thereunder, by such payment of the penalty if the order in- person and affords such person an op- cludes an agreement to pay a penalty. portunity for a hearing regarding the (b) If the order includes an agreement matter as provided by the Act; to pay a penalty and the penalty is not (2) Such person expressly waives paid within the time designated in such hearing and agrees to a specified order a stipulation, the amount of the pen- which may include an agreement to alty shall not be relevant in any re- pay a specified penalty within a des- spect to the penalty which may be as- ignated time; and sessed after issuance of a complaint. (3) The Administrator agrees to accept the order in settlement of the par- PARTS 168–199 [RESERVED]

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A list of CFR titles, subtitles, chapters, subchapters and parts and an alphabetical list of agencies publishing in the CFR are included in the CFR Index and Finding Aids volume of the Code of Federal Regulations which is published separately and revised annually. Table of CFR Titles and Chapters Alphabetical List of Agencies Appearing in the CFR List of CFR Sections Affected

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Title 1—General Provisions

I Administrative Committee of the Federal Register (Parts 1—49) II Office of the Federal Register (Parts 50—299) III Administrative Conference of the United States (Parts 300—399) IV Miscellaneous Agencies (Parts 400—500)

Title 2—Grants and Agreements

SUBTITLE A—OFFICE OF MANAGEMENT AND BUDGET GUIDANCE FOR GRANTS AND AGREEMENTS I Office of Management and Budget Governmentwide Guidance for Grants and Agreements (Parts 2—199) II Office of Management and Budget Circulars and Guidance (200— 299) SUBTITLE B—FEDERAL AGENCY REGULATIONS FOR GRANTS AND AGREEMENTS III Department of Health and Human Services (Parts 300— 399) IV Department of Agriculture (Parts 400—499) VI Department of State (Parts 600—699) VII Agency for International Development (Parts 700—799) VIII Department of Veterans Affairs (Parts 800—899) IX Department of Energy (Parts 900—999) XI Department of Defense (Parts 1100—1199) XII Department of Transportation (Parts 1200—1299) XIII Department of Commerce (Parts 1300—1399) XIV Department of the Interior (Parts 1400—1499) XV Environmental Protection Agency (Parts 1500—1599) XVIII National Aeronautics and Space Administration (Parts 1800— 1899) XX United States Nuclear Regulatory Commission (Parts 2000—2099) XXII Corporation for National and Community Service (Parts 2200— 2299) XXIII Social Security Administration (Parts 2300—2399) XXIV Housing and Urban Development (Parts 2400—2499) XXV National Science Foundation (Parts 2500—2599) XXVI National Archives and Records Administration (Parts 2600—2699) XXVII Small Business Administration (Parts 2700—2799) XXVIII Department of Justice (Parts 2800—2899)

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XXX Department of Homeland Security (Parts 3000—3099) XXXI Institute of Museum and Library Services (Parts 3100—3199) XXXII National Endowment for the Arts (Parts 3200—3299) XXXIII National Endowment for the Humanities (Parts 3300—3399) XXXIV Department of Education (Parts 3400—3499) XXXV Export-Import Bank of the United States (Parts 3500—3599) XXXVII Peace Corps (Parts 3700—3799) LVIII Election Assistance Commission (Parts 5800—5899)

Title 3—The President

I Executive Office of the President (Parts 100—199)

Title 4—Accounts

I Government Accountability Office (Parts 1—199) II Recovery Accountability and Transparency Board (Parts 200— 299)

Title 5—Administrative Personnel

I Office of Personnel Management (Parts 1—1199) II Merit Systems Protection Board (Parts 1200—1299) III Office of Management and Budget (Parts 1300—1399) V The International Organizations Employees Loyalty Board (Parts 1500—1599) VI Federal Retirement Thrift Investment Board (Parts 1600—1699) VIII Office of Special Counsel (Parts 1800—1899) IX Appalachian Regional Commission (Parts 1900—1999) XI Armed Forces Retirement Home (Parts 2100—2199) XIV Federal Labor Relations Authority, General Counsel of the Fed- eral Labor Relations Authority and Federal Service Impasses Panel (Parts 2400—2499) XV Office of Administration, Executive Office of the President (Parts 2500—2599) XVI Office of Government Ethics (Parts 2600—2699) XXI Department of the Treasury (Parts 3100—3199) XXII Federal Deposit Insurance Corporation (Parts 3200—3299) XXIII Department of Energy (Parts 3300—3399) XXIV Federal Energy Regulatory Commission (Parts 3400—3499) XXV Department of the Interior (Parts 3500—3599) XXVI Department of Defense (Parts 3600— 3699) XXVIII Department of Justice (Parts 3800—3899) XXIX Federal Communications Commission (Parts 3900—3999) XXX Farm Credit System Insurance Corporation (Parts 4000—4099) XXXI Farm Credit Administration (Parts 4100—4199)

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XXXIII Overseas Private Investment Corporation (Parts 4300—4399) XXXIV Securities and Exchange Commission (Parts 4400—4499) XXXV Office of Personnel Management (Parts 4500—4599) XXXVII Federal Election Commission (Parts 4700—4799) XL Interstate Commerce Commission (Parts 5000—5099) XLI Commodity Futures Trading Commission (Parts 5100—5199) XLII Department of Labor (Parts 5200—5299) XLIII National Science Foundation (Parts 5300—5399) XLV Department of Health and Human Services (Parts 5500—5599) XLVI Postal Rate Commission (Parts 5600—5699) XLVII Federal Trade Commission (Parts 5700—5799) XLVIII Nuclear Regulatory Commission (Parts 5800—5899) XLIX Federal Labor Relations Authority (Parts 5900—5999) L Department of Transportation (Parts 6000—6099) LII Export-Import Bank of the United States (Parts 6200—6299) LIII Department of Education (Parts 6300—6399) LIV Environmental Protection Agency (Parts 6400—6499) LV National Endowment for the Arts (Parts 6500—6599) LVI National Endowment for the Humanities (Parts 6600—6699) LVII General Services Administration (Parts 6700—6799) LVIII Board of Governors of the Federal Reserve System (Parts 6800— 6899) LIX National Aeronautics and Space Administration (Parts 6900— 6999) LX United States Postal Service (Parts 7000—7099) LXI National Labor Relations Board (Parts 7100—7199) LXII Equal Employment Opportunity Commission (Parts 7200—7299) LXIII Inter-American Foundation (Parts 7300—7399) LXIV Merit Systems Protection Board (Parts 7400—7499) LXV Department of Housing and Urban Development (Parts 7500— 7599) LXVI National Archives and Records Administration (Parts 7600—7699) LXVII Institute of Museum and Library Services (Parts 7700—7799) LXVIII Commission on Civil Rights (Parts 7800—7899) LXIX Tennessee Valley Authority (Parts 7900—7999) LXX Court Services and Offender Supervision Agency for the District of Columbia (Parts 8000—8099) LXXI Consumer Product Safety Commission (Parts 8100—8199) LXXIII Department of Agriculture (Parts 8300—8399) LXXIV Federal Mine Safety and Health Review Commission (Parts 8400—8499) LXXVI Federal Retirement Thrift Investment Board (Parts 8600—8699) LXXVII Office of Management and Budget (Parts 8700—8799) LXXX Federal Housing Finance Agency (Parts 9000—9099) LXXXII Special Inspector General for Iraq Reconstruction (Parts 9200— 9299)

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LXXXIII Special Inspector General for Afghanistan Reconstruction (Parts 9300—9399) LXXXIV Bureau of Consumer Financial Protection (Parts 9400—9499) XCVII Department of Homeland Security Human Resources Manage- ment System (Department of Homeland Security—Office of Personnel Management) (Parts 9700—9799) XCVII Council of the Inspectors General on Integrity and Efficiency (Parts 9800—9899)

Title 6—Domestic Security

I Department of Homeland Security, Office of the Secretary (Parts 1—99)

Title 7—Agriculture

SUBTITLE A—OFFICE OF THE SECRETARY OF AGRICULTURE (PARTS 0—26) SUBTITLE B—REGULATIONS OF THE DEPARTMENT OF AGRICULTURE I Agricultural Marketing Service (Standards, Inspections, Mar- keting Practices), Department of Agriculture (Parts 27—209) II Food and Nutrition Service, Department of Agriculture (Parts 210—299) III Animal and Plant Health Inspection Service, Department of Ag- riculture (Parts 300—399) IV Federal Crop Insurance Corporation, Department of Agriculture (Parts 400—499) V Agricultural Research Service, Department of Agriculture (Parts 500—599) VI Natural Resources Conservation Service, Department of Agri- culture (Parts 600—699) VII Farm Service Agency, Department of Agriculture (Parts 700— 799) VIII Grain Inspection, Packers and Stockyards Administration (Fed- eral Grain Inspection Service), Department of Agriculture (Parts 800—899) IX Agricultural Marketing Service (Marketing Agreements and Or- ders; Fruits, Vegetables, Nuts), Department of Agriculture (Parts 900—999) X Agricultural Marketing Service (Marketing Agreements and Or- ders; Milk), Department of Agriculture (Parts 1000—1199) XI Agricultural Marketing Service (Marketing Agreements and Or- ders; Miscellaneous Commodities), Department of Agriculture (Parts 1200—1299) XIV Commodity Credit Corporation, Department of Agriculture (Parts 1400—1499) XV Foreign Agricultural Service, Department of Agriculture (Parts 1500—1599) XVI Rural Telephone Bank, Department of Agriculture (Parts 1600— 1699)

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XVII Rural Utilities Service, Department of Agriculture (Parts 1700— 1799) XVIII Rural Housing Service, Rural Business-Cooperative Service, Rural Utilities Service, and Farm Service Agency, Depart- ment of Agriculture (Parts 1800—2099) XX Local Television Loan Guarantee Board (Parts 2200—2299) XXV Office of Advocacy and Outreach, Department of Agriculture (Parts 2500—2599) XXVI Office of Inspector General, Department of Agriculture (Parts 2600—2699) XXVII Office of Information Resources Management, Department of Agriculture (Parts 2700—2799) XXVIII Office of Operations, Department of Agriculture (Parts 2800— 2899) XXIX Office of Energy Policy and New Uses, Department of Agri- culture (Parts 2900—2999) XXX Office of the Chief Financial Officer, Department of Agriculture (Parts 3000—3099) XXXI Office of Environmental Quality, Department of Agriculture (Parts 3100—3199) XXXII Office of Procurement and Property Management, Department of Agriculture (Parts 3200—3299) XXXIII Office of Transportation, Department of Agriculture (Parts 3300—3399) XXXIV National Institute of Food and Agriculture (Parts 3400—3499) XXXV Rural Housing Service, Department of Agriculture (Parts 3500— 3599) XXXVI National Agricultural Statistics Service, Department of Agri- culture (Parts 3600—3699) XXXVII Economic Research Service, Department of Agriculture (Parts 3700—3799) XXXVIII World Agricultural Outlook Board, Department of Agriculture (Parts 3800—3899) XLI [Reserved] XLII Rural Business-Cooperative Service and Rural Utilities Service, Department of Agriculture (Parts 4200—4299)

Title 8—Aliens and Nationality

I Department of Homeland Security (Immigration and Naturaliza- tion) (Parts 1—499) V Executive Office for Immigration Review, Department of Justice (Parts 1000—1399)

Title 9—Animals and Animal Products

I Animal and Plant Health Inspection Service, Department of Ag- riculture (Parts 1—199)

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II Grain Inspection, Packers and Stockyards Administration (Packers and Stockyards Programs), Department of Agri- culture (Parts 200—299) III Food Safety and Inspection Service, Department of Agriculture (Parts 300—599)

Title 10—Energy

I Nuclear Regulatory Commission (Parts 0—199) II Department of Energy (Parts 200—699) III Department of Energy (Parts 700—999) X Department of Energy (General Provisions) (Parts 1000—1099) XIII Nuclear Waste Technical Review Board (Parts 1300—1399) XVII Defense Nuclear Facilities Safety Board (Parts 1700—1799) XVIII Northeast Interstate Low-Level Radioactive Waste Commission (Parts 1800—1899)

Title 11—Federal Elections

I Federal Election Commission (Parts 1—9099) II Election Assistance Commission (Parts 9400—9499)

Title 12—Banks and Banking

I Comptroller of the Currency, Department of the Treasury (Parts 1—199) II Federal Reserve System (Parts 200—299) III Federal Deposit Insurance Corporation (Parts 300—399) IV Export-Import Bank of the United States (Parts 400—499) V Office of Thrift Supervision, Department of the Treasury (Parts 500—599) VI Farm Credit Administration (Parts 600—699) VII National Credit Union Administration (Parts 700—799) VIII Federal Financing Bank (Parts 800—899) IX Federal Housing Finance Board (Parts 900—999) X Bureau of Consumer Financial Protection (Parts 1000—1099) XI Federal Financial Institutions Examination Council (Parts 1100—1199) XII Federal Housing Finance Agency (Parts 1200—1299) XIII Financial Stability Oversight Council (Parts 1300—1399) XIV Farm Credit System Insurance Corporation (Parts 1400—1499) XV Department of the Treasury (Parts 1500—1599) XVI Office of Financial Research (Parts 1600—1699) XVII Office of Federal Housing Enterprise Oversight, Department of Housing and Urban Development (Parts 1700—1799) XVIII Community Development Financial Institutions Fund, Depart- ment of the Treasury (Parts 1800—1899)

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I Small Business Administration (Parts 1—199) III Economic Development Administration, Department of Com- merce (Parts 300—399) IV Emergency Steel Guarantee Loan Board (Parts 400—499) V Emergency Oil and Gas Guaranteed Loan Board (Parts 500—599)

Title 14—Aeronautics and Space

I Federal Aviation Administration, Department of Transportation (Parts 1—199) II Office of the Secretary, Department of Transportation (Aviation Proceedings) (Parts 200—399) III Commercial Space Transportation, Federal Aviation Adminis- tration, Department of Transportation (Parts 400—1199) V National Aeronautics and Space Administration (Parts 1200— 1299) VI Air Transportation System Stabilization (Parts 1300—1399)

Title 15—Commerce and Foreign Trade

SUBTITLE A—OFFICE OF THE SECRETARY OF COMMERCE (PARTS 0— 29) SUBTITLE B—REGULATIONS RELATING TO COMMERCE AND FOREIGN TRADE I Bureau of the Census, Department of Commerce (Parts 30—199) II National Institute of Standards and Technology, Department of Commerce (Parts 200—299) III International Trade Administration, Department of Commerce (Parts 300—399) IV Foreign-Trade Zones Board, Department of Commerce (Parts 400—499) VII Bureau of Industry and Security, Department of Commerce (Parts 700—799) VIII Bureau of Economic Analysis, Department of Commerce (Parts 800—899) IX National Oceanic and Atmospheric Administration, Department of Commerce (Parts 900—999) XI Technology Administration, Department of Commerce (Parts 1100—1199) XIII East-West Foreign Trade Board (Parts 1300—1399) XIV Minority Business Development Agency (Parts 1400—1499) SUBTITLE C—REGULATIONS RELATING TO FOREIGN TRADE AGREE- MENTS XX Office of the United States Trade Representative (Parts 2000— 2099) SUBTITLE D—REGULATIONS RELATING TO TELECOMMUNICATIONS AND INFORMATION XXIII National Telecommunications and Information Administration, Department of Commerce (Parts 2300—2399)

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I Federal Trade Commission (Parts 0—999) II Consumer Product Safety Commission (Parts 1000—1799)

Title 17—Commodity and Securities Exchanges

I Commodity Futures Trading Commission (Parts 1—199) II Securities and Exchange Commission (Parts 200—399) IV Department of the Treasury (Parts 400—499)

Title 18—Conservation of Power and Water Resources

I Federal Energy Regulatory Commission, Department of Energy (Parts 1—399) III Delaware River Basin Commission (Parts 400—499) VI Water Resources Council (Parts 700—799) VIII Susquehanna River Basin Commission (Parts 800—899) XIII Tennessee Valley Authority (Parts 1300—1399)

Title 19—Customs Duties

I U.S. Customs and Border Protection, Department of Homeland Security; Department of the Treasury (Parts 0—199) II United States International Trade Commission (Parts 200—299) III International Trade Administration, Department of Commerce (Parts 300—399) IV U.S. Immigration and Customs Enforcement, Department of Homeland Security (Parts 400—599)

Title 20—Employees’ Benefits

I Office of Workers’ Compensation Programs, Department of Labor (Parts 1—199) II Railroad Retirement Board (Parts 200—399) III Social Security Administration (Parts 400—499) IV Employees’ Compensation Appeals Board, Department of Labor (Parts 500—599) V Employment and Training Administration, Department of Labor (Parts 600—699) VI Office of Workers’ Compensation Programs, Department of Labor (Parts 700—799) VII Benefits Review Board, Department of Labor (Parts 800—899) VIII Joint Board for the Enrollment of Actuaries (Parts 900—999) IX Office of the Assistant Secretary for Veterans’ Employment and Training Service, Department of Labor (Parts 1000—1099)

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I Food and Drug Administration, Department of Health and Human Services (Parts 1—1299) II Drug Enforcement Administration, Department of Justice (Parts 1300—1399) III Office of National Drug Control Policy (Parts 1400—1499)

Title 22—Foreign Relations

I Department of State (Parts 1—199) II Agency for International Development (Parts 200—299) III Peace Corps (Parts 300—399) IV International Joint Commission, United States and Canada (Parts 400—499) V Broadcasting Board of Governors (Parts 500—599) VII Overseas Private Investment Corporation (Parts 700—799) IX Foreign Service Grievance Board (Parts 900—999) X Inter-American Foundation (Parts 1000—1099) XI International Boundary and Water Commission, United States and Mexico, United States Section (Parts 1100—1199) XII United States International Development Cooperation Agency (Parts 1200—1299) XIII Millennium Challenge Corporation (Parts 1300—1399) XIV Foreign Service Labor Relations Board; Federal Labor Relations Authority; General Counsel of the Federal Labor Relations Authority; and the Foreign Service Impasse Disputes Panel (Parts 1400—1499) XV African Development Foundation (Parts 1500—1599) XVI Japan-United States Friendship Commission (Parts 1600—1699) XVII United States Institute of Peace (Parts 1700—1799)

Title 23—Highways

I Federal Highway Administration, Department of Transportation (Parts 1—999) II National Highway Traffic Safety Administration and Federal Highway Administration, Department of Transportation (Parts 1200—1299) III National Highway Traffic Safety Administration, Department of Transportation (Parts 1300—1399)

Title 24—Housing and Urban Development

SUBTITLE A—OFFICE OF THE SECRETARY, DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT (PARTS 0—99) SUBTITLE B—REGULATIONS RELATING TO HOUSING AND URBAN DE- VELOPMENT I Office of Assistant Secretary for Equal Opportunity, Department of Housing and Urban Development (Parts 100—199)

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II Office of Assistant Secretary for Housing-Federal Housing Com- missioner, Department of Housing and Urban Development (Parts 200—299) III Government National Mortgage Association, Department of Housing and Urban Development (Parts 300—399) IV Office of Housing and Office of Multifamily Housing Assistance Restructuring, Department of Housing and Urban Develop- ment (Parts 400—499) V Office of Assistant Secretary for Community Planning and De- velopment, Department of Housing and Urban Development (Parts 500—599) VI Office of Assistant Secretary for Community Planning and De- velopment, Department of Housing and Urban Development (Parts 600—699) [Reserved] VII Office of the Secretary, Department of Housing and Urban Devel- opment (Housing Assistance Programs and Public and Indian Housing Programs) (Parts 700—799) VIII Office of the Assistant Secretary for Housing—Federal Housing Commissioner, Department of Housing and Urban Develop- ment (Section 8 Housing Assistance Programs, Section 202 Di- rect Loan Program, Section 202 Supportive Housing for the El- derly Program and Section 811 Supportive Housing for Persons With Disabilities Program) (Parts 800—899) IX Office of Assistant Secretary for Public and Indian Housing, De- partment of Housing and Urban Development (Parts 900—1699) X Office of Assistant Secretary for Housing—Federal Housing Commissioner, Department of Housing and Urban Develop- ment (Interstate Land Sales Registration Program) (Parts 1700—1799) XII Office of Inspector General, Department of Housing and Urban Development (Parts 2000—2099) XV Emergency Mortgage Insurance and Loan Programs, Depart- ment of Housing and Urban Development (Parts 2700—2799) XX Office of Assistant Secretary for Housing—Federal Housing Commissioner, Department of Housing and Urban Develop- ment (Parts 3200—3899) XXIV Board of Directors of the HOPE for Homeowners Program (Parts 4000—4099) XXV Neighborhood Reinvestment Corporation (Parts 4100—4199)

Title 25—Indians

I Bureau of Indian Affairs, Department of the Interior (Parts 1— 299) II Indian Arts and Crafts Board, Department of the Interior (Parts 300—399) III National Indian Gaming Commission, Department of the Inte- rior (Parts 500—599) IV Office of Navajo and Hopi Indian Relocation (Parts 700—799) V Bureau of Indian Affairs, Department of the Interior, and Indian Health Service, Department of Health and Human Services (Part 900)

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VI Office of the Assistant Secretary-Indian Affairs, Department of the Interior (Parts 1000—1199) VII Office of the Special Trustee for American Indians, Department of the Interior (Parts 1200—1299)

Title 26—Internal Revenue

I Internal Revenue Service, Department of the Treasury (Parts 1— End)

Title 27—Alcohol, Tobacco Products and Firearms

I Alcohol and Tobacco Tax and Trade Bureau, Department of the Treasury (Parts 1—399) II Bureau of Alcohol, Tobacco, Firearms, and Explosives, Depart- ment of Justice (Parts 400—699)

Title 28—Judicial Administration

I Department of Justice (Parts 0—299) III Federal Prison Industries, Inc., Department of Justice (Parts 300—399) V Bureau of Prisons, Department of Justice (Parts 500—599) VI Offices of Independent Counsel, Department of Justice (Parts 600—699) VII Office of Independent Counsel (Parts 700—799) VIII Court Services and Offender Supervision Agency for the District of Columbia (Parts 800—899) IX National Crime Prevention and Privacy Compact Council (Parts 900—999) XI Department of Justice and Department of State (Parts 1100— 1199)

Title 29—Labor

SUBTITLE A—OFFICE OF THE SECRETARY OF LABOR (PARTS 0—99) SUBTITLE B—REGULATIONS RELATING TO LABOR I National Labor Relations Board (Parts 100—199) II Office of Labor-Management Standards, Department of Labor (Parts 200—299) III National Railroad Adjustment Board (Parts 300—399) IV Office of Labor-Management Standards, Department of Labor (Parts 400—499) V Wage and Hour Division, Department of Labor (Parts 500—899) IX Construction Industry Collective Bargaining Commission (Parts 900—999) X National Mediation Board (Parts 1200—1299) XII Federal Mediation and Conciliation Service (Parts 1400—1499) XIV Equal Employment Opportunity Commission (Parts 1600—1699)

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XVII Occupational Safety and Health Administration, Department of Labor (Parts 1900—1999) XX Occupational Safety and Health Review Commission (Parts 2200—2499) XXV Employee Benefits Security Administration, Department of Labor (Parts 2500—2599) XXVII Federal Mine Safety and Health Review Commission (Parts 2700—2799) XL Pension Benefit Guaranty Corporation (Parts 4000—4999)

Title 30—Mineral Resources

I Mine Safety and Health Administration, Department of Labor (Parts 1—199) II Bureau of Safety and Environmental Enforcement, Department of the Interior (Parts 200—299) IV Geological Survey, Department of the Interior (Parts 400—499) V Bureau of Ocean Energy Management, Department of the Inte- rior (Parts 500—599) VII Office of Surface Mining Reclamation and Enforcement, Depart- ment of the Interior (Parts 700—999) XII Office of Natural Resources Revenue, Department of the Interior (Parts 1200—1299)

Title 31—Money and Finance: Treasury

SUBTITLE A—OFFICE OF THE SECRETARY OF THE TREASURY (PARTS 0—50) SUBTITLE B—REGULATIONS RELATING TO MONEY AND FINANCE I Monetary Offices, Department of the Treasury (Parts 51—199) II Fiscal Service, Department of the Treasury (Parts 200—399) IV Secret Service, Department of the Treasury (Parts 400—499) V Office of Foreign Assets Control, Department of the Treasury (Parts 500—599) VI Bureau of Engraving and Printing, Department of the Treasury (Parts 600—699) VII Federal Law Enforcement Training Center, Department of the Treasury (Parts 700—799) VIII Office of International Investment, Department of the Treasury (Parts 800—899) IX Federal Claims Collection Standards (Department of the Treas- ury—Department of Justice) (Parts 900—999) X Financial Crimes Enforcement Network, Department of the Treasury (Parts 1000—1099)

Title 32—National Defense

SUBTITLE A—DEPARTMENT OF DEFENSE I Office of the Secretary of Defense (Parts 1—399)

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V Department of the Army (Parts 400—699) VI Department of the Navy (Parts 700—799) VII Department of the Air Force (Parts 800—1099) SUBTITLE B—OTHER REGULATIONS RELATING TO NATIONAL DE- FENSE XII Defense Logistics Agency (Parts 1200—1299) XVI Selective Service System (Parts 1600—1699) XVII Office of the Director of National Intelligence (Parts 1700—1799) XVIII National Counterintelligence Center (Parts 1800—1899) XIX Central Intelligence Agency (Parts 1900—1999) XX Information Security Oversight Office, National Archives and Records Administration (Parts 2000—2099) XXI National Security Council (Parts 2100—2199) XXIV Office of Science and Technology Policy (Parts 2400—2499) XXVII Office for Micronesian Status Negotiations (Parts 2700—2799) XXVIII Office of the Vice President of the United States (Parts 2800— 2899)

Title 33—Navigation and Navigable Waters

I Coast Guard, Department of Homeland Security (Parts 1—199) II Corps of Engineers, Department of the Army (Parts 200—399) IV Saint Lawrence Seaway Development Corporation, Department of Transportation (Parts 400—499)

Title 34—Education

SUBTITLE A—OFFICE OF THE SECRETARY, DEPARTMENT OF EDU- CATION (PARTS 1—99) SUBTITLE B—REGULATIONS OF THE OFFICES OF THE DEPARTMENT OF EDUCATION I Office for Civil Rights, Department of Education (Parts 100—199) II Office of Elementary and Secondary Education, Department of Education (Parts 200—299) III Office of Special Education and Rehabilitative Services, Depart- ment of Education (Parts 300—399) IV Office of Vocational and Adult Education, Department of Edu- cation (Parts 400—499) V Office of Bilingual Education and Minority Languages Affairs, Department of Education (Parts 500—599) VI Office of Postsecondary Education, Department of Education (Parts 600—699) VII Office of Educational Research and Improvement, Department of Education [Reserved] XI National Institute for Literacy (Parts 1100—1199) SUBTITLE C—REGULATIONS RELATING TO EDUCATION XII National Council on Disability (Parts 1200—1299)

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Title 36—Parks, Forests, and Public Property

I National Park Service, Department of the Interior (Parts 1—199) II Forest Service, Department of Agriculture (Parts 200—299) III Corps of Engineers, Department of the Army (Parts 300—399) IV American Battle Monuments Commission (Parts 400—499) V Smithsonian Institution (Parts 500—599) VI [Reserved] VII Library of Congress (Parts 700—799) VIII Advisory Council on Historic Preservation (Parts 800—899) IX Pennsylvania Avenue Development Corporation (Parts 900—999) X Presidio Trust (Parts 1000—1099) XI Architectural and Transportation Barriers Compliance Board (Parts 1100—1199) XII National Archives and Records Administration (Parts 1200—1299) XV Oklahoma City National Memorial Trust (Parts 1500—1599) XVI Morris K. Udall Scholarship and Excellence in National Environ- mental Policy Foundation (Parts 1600—1699)

Title 37—Patents, Trademarks, and Copyrights

I United States Patent and Trademark Office, Department of Commerce (Parts 1—199) II Copyright Office, Library of Congress (Parts 200—299) III Copyright Royalty Board, Library of Congress (Parts 300—399) IV Assistant Secretary for Technology Policy, Department of Com- merce (Parts 400—499) V Under Secretary for Technology, Department of Commerce (Parts 500—599)

Title 38—Pensions, Bonuses, and Veterans’ Relief

I Department of Veterans Affairs (Parts 0—199) II Armed Forces Retirement Home (Parts 200—299)

Title 39—Postal Service

I United States Postal Service (Parts 1—999) III Postal Regulatory Commission (Parts 3000—3099)

Title 40—Protection of Environment

I Environmental Protection Agency (Parts 1—1099) IV Environmental Protection Agency and Department of Justice (Parts 1400—1499) V Council on Environmental Quality (Parts 1500—1599)

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VI Chemical Safety and Hazard Investigation Board (Parts 1600— 1699) VII Environmental Protection Agency and Department of Defense; Uniform National Discharge Standards for Vessels of the Armed Forces (Parts 1700—1799)

Title 41—Public Contracts and Property Management

SUBTITLE A—FEDERAL PROCUREMENT REGULATIONS SYSTEM [NOTE] SUBTITLE B—OTHER PROVISIONS RELATING TO PUBLIC CONTRACTS 50 Public Contracts, Department of Labor (Parts 50–1—50–999) 51 Committee for Purchase From People Who Are Blind or Severely Disabled (Parts 51–1—51–99) 60 Office of Federal Contract Compliance Programs, Equal Employ- ment Opportunity, Department of Labor (Parts 60–1—60–999) 61 Office of the Assistant Secretary for Veterans’ Employment and Training Service, Department of Labor (Parts 61–1—61–999) 62—100 [Reserved] SUBTITLE C—FEDERAL PROPERTY MANAGEMENT REGULATIONS SYSTEM 101 Federal Property Management Regulations (Parts 101–1—101–99) 102 Federal Management Regulation (Parts 102–1—102–299) 103—104 [Reserved] 105 General Services Administration (Parts 105–1—105–999) 109 Department of Energy Property Management Regulations (Parts 109–1—109–99) 114 Department of the Interior (Parts 114–1—114–99) 115 Environmental Protection Agency (Parts 115–1—115–99) 128 Department of Justice (Parts 128–1—128–99) 129—200 [Reserved] SUBTITLE D—OTHER PROVISIONS RELATING TO PROPERTY MANAGE- MENT [RESERVED] SUBTITLE E—FEDERAL INFORMATION RESOURCES MANAGEMENT REGULATIONS SYSTEM [RESERVED] SUBTITLE F—FEDERAL TRAVEL REGULATION SYSTEM 300 General (Parts 300–1—300–99) 301 Temporary Duty (TDY) Travel Allowances (Parts 301–1—301–99) 302 Relocation Allowances (Parts 302–1—302–99) 303 Payment of Expenses Connected with the Death of Certain Em- ployees (Part 303–1—303–99) 304 Payment of Travel Expenses from a Non-Federal Source (Parts 304–1—304–99)

Title 42—Public Health

I Public Health Service, Department of Health and Human Serv- ices (Parts 1—199)

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IV Centers for Medicare & Medicaid Services, Department of Health and Human Services (Parts 400—599) V Office of Inspector General-Health Care, Department of Health and Human Services (Parts 1000—1999)

Title 43—Public Lands: Interior

SUBTITLE A—OFFICE OF THE SECRETARY OF THE INTERIOR (PARTS 1—199) SUBTITLE B—REGULATIONS RELATING TO PUBLIC LANDS I Bureau of Reclamation, Department of the Interior (Parts 400— 999) II Bureau of Land Management, Department of the Interior (Parts 1000—9999) III Utah Reclamation Mitigation and Conservation Commission (Parts 10000—10099)

Title 44—Emergency Management and Assistance

I Federal Emergency Management Agency, Department of Home- land Security (Parts 0—399) IV Department of Commerce and Department of Transportation (Parts 400—499)

Title 45—Public Welfare

SUBTITLE A—DEPARTMENT OF HEALTH AND HUMAN SERVICES (PARTS 1—199) SUBTITLE B—REGULATIONS RELATING TO PUBLIC WELFARE II Office of Family Assistance (Assistance Programs), Administra- tion for Children and Families, Department of Health and Human Services (Parts 200—299) III Office of Child Support Enforcement (Child Support Enforce- ment Program), Administration for Children and Families, Department of Health and Human Services (Parts 300—399) IV Office of Refugee Resettlement, Administration for Children and Families, Department of Health and Human Services (Parts 400—499) V Foreign Claims Settlement Commission of the United States, Department of Justice (Parts 500—599) VI National Science Foundation (Parts 600—699) VII Commission on Civil Rights (Parts 700—799) VIII Office of Personnel Management (Parts 800—899) [Reserved] X Office of Community Services, Administration for Children and Families, Department of Health and Human Services (Parts 1000—1099) XI National Foundation on the Arts and the Humanities (Parts 1100—1199) XII Corporation for National and Community Service (Parts 1200— 1299)

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XIII Office of Human Development Services, Department of Health and Human Services (Parts 1300—1399) XVI Legal Services Corporation (Parts 1600—1699) XVII National Commission on Libraries and Information Science (Parts 1700—1799) XVIII Harry S. Truman Scholarship Foundation (Parts 1800—1899) XXI Commission on Fine Arts (Parts 2100—2199) XXIII Arctic Research Commission (Part 2301) XXIV James Madison Memorial Fellowship Foundation (Parts 2400— 2499) XXV Corporation for National and Community Service (Parts 2500— 2599)

Title 46—Shipping

I Coast Guard, Department of Homeland Security (Parts 1—199) II Maritime Administration, Department of Transportation (Parts 200—399) III Coast Guard (Great Lakes Pilotage), Department of Homeland Security (Parts 400—499) IV Federal Maritime Commission (Parts 500—599)

Title 47—Telecommunication

I Federal Communications Commission (Parts 0—199) II Office of Science and Technology Policy and National Security Council (Parts 200—299) III National Telecommunications and Information Administration, Department of Commerce (Parts 300—399) IV National Telecommunications and Information Administration, Department of Commerce, and National Highway Traffic Safe- ty Administration, Department of Transportation (Parts 400— 499)

Title 48—Federal Acquisition Regulations System

1 Federal Acquisition Regulation (Parts 1—99) 2 Defense Acquisition Regulations System, Department of Defense (Parts 200—299) 3 Health and Human Services (Parts 300—399) 4 Department of Agriculture (Parts 400—499) 5 General Services Administration (Parts 500—599) 6 Department of State (Parts 600—699) 7 Agency for International Development (Parts 700—799) 8 Department of Veterans Affairs (Parts 800—899) 9 Department of Energy (Parts 900—999) 10 Department of the Treasury (Parts 1000—1099) 12 Department of Transportation (Parts 1200—1299)

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13 Department of Commerce (Parts 1300—1399) 14 Department of the Interior (Parts 1400—1499) 15 Environmental Protection Agency (Parts 1500—1599) 16 Office of Personnel Management, Federal Employees Health Benefits Acquisition Regulation (Parts 1600—1699) 17 Office of Personnel Management (Parts 1700—1799) 18 National Aeronautics and Space Administration (Parts 1800— 1899) 19 Broadcasting Board of Governors (Parts 1900—1999) 20 Nuclear Regulatory Commission (Parts 2000—2099) 21 Office of Personnel Management, Federal Employees Group Life Insurance Federal Acquisition Regulation (Parts 2100—2199) 23 Social Security Administration (Parts 2300—2399) 24 Department of Housing and Urban Development (Parts 2400— 2499) 25 National Science Foundation (Parts 2500—2599) 28 Department of Justice (Parts 2800—2899) 29 Department of Labor (Parts 2900—2999) 30 Department of Homeland Security, Homeland Security Acquisi- tion Regulation (HSAR) (Parts 3000—3099) 34 Department of Education Acquisition Regulation (Parts 3400— 3499) 51 Department of the Army Acquisition Regulations (Parts 5100— 5199) 52 Department of the Navy Acquisition Regulations (Parts 5200— 5299) 53 Department of the Air Force Federal Acquisition Regulation Supplement [Reserved] 54 Defense Logistics Agency, Department of Defense (Parts 5400— 5499) 57 African Development Foundation (Parts 5700—5799) 61 Civilian Board of Contract Appeals, General Services Adminis- tration (Parts 6100—6199) 63 Department of Transportation Board of Contract Appeals (Parts 6300—6399) 99 Cost Accounting Standards Board, Office of Federal Procure- ment Policy, Office of Management and Budget (Parts 9900— 9999)

Title 49—Transportation

SUBTITLE A—OFFICE OF THE SECRETARY OF TRANSPORTATION (PARTS 1—99) SUBTITLE B—OTHER REGULATIONS RELATING TO TRANSPORTATION I Pipeline and Hazardous Materials Safety Administration, De- partment of Transportation (Parts 100—199) II Federal Railroad Administration, Department of Transportation (Parts 200—299)

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III Federal Motor Carrier Safety Administration, Department of Transportation (Parts 300—399) IV Coast Guard, Department of Homeland Security (Parts 400—499) V National Highway Traffic Safety Administration, Department of Transportation (Parts 500—599) VI Federal Transit Administration, Department of Transportation (Parts 600—699) VII National Railroad Passenger Corporation (AMTRAK) (Parts 700—799) VIII National Transportation Safety Board (Parts 800—999) X Surface Transportation Board, Department of Transportation (Parts 1000—1399) XI Research and Innovative Technology Administration, Depart- ment of Transportation [Reserved] XII Transportation Security Administration, Department of Home- land Security (Parts 1500—1699)

Title 50—Wildlife and Fisheries

I United States Fish and Wildlife Service, Department of the Inte- rior (Parts 1—199) II National Marine Fisheries Service, National Oceanic and Atmos- pheric Administration, Department of Commerce (Parts 200— 299) III International Fishing and Related Activities (Parts 300—399) IV Joint Regulations (United States Fish and Wildlife Service, De- partment of the Interior and National Marine Fisheries Serv- ice, National Oceanic and Atmospheric Administration, De- partment of Commerce); Endangered Species Committee Reg- ulations (Parts 400—499) V Marine Mammal Commission (Parts 500—599) VI Fishery Conservation and Management, National Oceanic and Atmospheric Administration, Department of Commerce (Parts 600—699)

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CFR Title, Subtitle or Agency Chapter Administrative Committee of the Federal Register 1, I Administrative Conference of the United States 1, III Advisory Council on Historic Preservation 36, VIII Advocacy and Outreach, Office of 7, XXV Afghanistan Reconstruction, Special Inspector General for 22, LXXXIII African Development Foundation 22, XV Federal Acquisition Regulation 48, 57 Agency for International Development 2, VII; 22, II Federal Acquisition Regulation 48, 7 Agricultural Marketing Service 7, I, IX, X, XI Agricultural Research Service 7, V Agriculture Department 2, IV; 5, LXXIII Advocacy and Outreach, Office of 7, XXV Agricultural Marketing Service 7, I, IX, X, XI Agricultural Research Service 7, V Animal and Plant Health Inspection Service 7, III; 9, I Chief Financial Officer, Office of 7, XXX Commodity Credit Corporation 7, XIV Economic Research Service 7, XXXVII Energy Policy and New Uses, Office of 2, IX; 7, XXIX Environmental Quality, Office of 7, XXXI Farm Service Agency 7, VII, XVIII Federal Acquisition Regulation 48, 4 Federal Crop Insurance Corporation 7, IV Food and Nutrition Service 7, II Food Safety and Inspection Service 9, III Foreign Agricultural Service 7, XV Forest Service 36, II Grain Inspection, Packers and Stockyards Administration 7, VIII; 9, II Information Resources Management, Office of 7, XXVII Inspector General, Office of 7, XXVI National Agricultural Library 7, XLI National Agricultural Statistics Service 7, XXXVI National Institute of Food and Agriculture 7, XXXIV Natural Resources Conservation Service 7, VI Operations, Office of 7, XXVIII Procurement and Property Management, Office of 7, XXXII Rural Business-Cooperative Service 7, XVIII, XLII, L Rural Development Administration 7, XLII Rural Housing Service 7, XVIII, XXXV, L Rural Telephone Bank 7, XVI Rural Utilities Service 7, XVII, XVIII, XLII, L Secretary of Agriculture, Office of 7, Subtitle A Transportation, Office of 7, XXXIII World Agricultural Outlook Board 7, XXXVIII Air Force Department 32, VII Federal Acquisition Regulation Supplement 48, 53 Air Transportation Stabilization Board 14, VI Alcohol and Tobacco Tax and Trade Bureau 27, I Alcohol, Tobacco, Firearms, and Explosives, Bureau of 27, II AMTRAK 49, VII American Battle Monuments Commission 36, IV American Indians, Office of the Special Trustee 25, VII

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2008 9 CFR—Continued 73 FR Page 9 CFR 73 FR Chapter I—Continued Page 82.7 Introductory text and (a) Chapter I through (d) redesignated as (a) 71.1 Amended; interim ...... 54062 introductory text and (1) 71.3 (a) amended; (c)(5) added; in- through (4); new (a)(2) amend- terim...... 52184 ed; new (b) added ...... 30298 Regulation at 73 FR 52184 eff. 82.8 (a)(2) amended; (a)(3) re- date delayed to 1–9–09 ...... 63867 vised...... 30299 71.22 Revised; interim...... 54062 82.9 (b) amended; (c) redesignated 77.2 Amended; interim ...... 54062 as (d); new (c) added...... 30299 77.7 (b)(1) designation and (2) re- 82.14 (c)(2) introductory text and moved; interim...... 52777 (e)(2) amended; (i) added...... 30299 (a) amended; interim...... 54065 83 Added; interim ...... 52184 77.9 (a) amended; interim ...... 19142 Regulation at 73 FR 52184 eff. (a) amended; (b)(1) designation date delayed to 1–9–09 ...... 63867 and (2) removed; interim ...... 52777 93.301 (c)(2)(vii) and footnote 6 (a) amended; interim...... 54065 amended; (c)(2)(viii) redesignated as (c)(2)(ix); new (b) revised; interim ...... 60102 (c)(2)(viii) added; (f) revised; 77.11 (a) amended; interim ...... 19142 OMB number ...... 31934 (a) and (b) revised; interim...... 60102 (j) amended ...... 50878 78.1 Amended...... 10138 (h)(6) and (7) amended...... 70257 Amended; interim...... 54062 93.304 (a)(1)(ii) amended; 78.41 (a) and (b) amended; in- (a)(1)(iii) redesignated as terim ...... 6008, 51355 (a)(1)(iv); new (a)(1)(iii) added; Regulation at 73 FR 6008 con- OMB number ...... 31936 firmed...... 49933 93.400 Amended ...... 3383 79.1 Amended; interim ...... 54062 93.405 (a)(4) amended ...... 3383 80.1 Amended; interim ...... 54062 (a)(3) amended ...... 50878 82.1 Amended...... 30297 93.419 (c), (e)(2), (5), (7)(i) and (iii) 82.4 (a)(2) amended...... 30297 revised ...... 3383 82.5 (a) and (b) introductory text 93.436 (a)(2) and (b)(3) revised ...... 3384 revised; (b)(5) amended ...... 30297 93.505 (b) amended ...... 50878 82.6 (b) revised ...... 30298 93.600 (a) amended...... 50878

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9 CFR—Continued 73 FR 9 CFR—Continued 73 FR Page Page Chapter I—Continued Chapter I—Continued 93.900 Amended; interim ...... 52186 95.4 (c)(3) through (7) redesig- Regulation at 73 FR 52186 eff. nated as (c)(4) through (8); date delayed to 1–9–09 ...... 63867 (c)(2), new (7) and (g)(2) revised; 93.901—93.906 Undesignated cen- new (c)(3) added ...... 3384 ter heading added; interim ...... 52186 121 Technical correction...... 63621 Regulation at 73 FR 52186 eff. Footnotes 1 through 14 redesig- date delayed to 1–9–09 ...... 63867 nated as footnotes 2 through 15 93.910 Undesignated center head- ...... 61331 ing and section added; in- 121.3 (b) revised...... 61331 terim...... 52186 121.4 (b) revised; (d)(3) removed; Regulation at 73 FR 52186 eff. (f)(3)(i) amended ...... 61331 date delayed to 1–9–09 ...... 63867 121.5 (a)(3)(i) amended...... 61331 93.911 Added; interim...... 52186 121.6 (a)(3)(i) amended...... 61331 Regulation at 73 FR 52186 eff. 121.9 (c)(1) amended ...... 61332 date delayed to 1–9–09 ...... 63867 149 Added ...... 60479 93.912 Added; interim...... 52186 160.1 Amended ...... 60488 Regulation at 73 FR 52186 eff. 161.5 Added ...... 60488 date delayed to 1–9–09 ...... 63867 93.913 Added; interim...... 52186 2009 Regulation at 73 FR 52186 eff. 9 CFR 74 FR date delayed to 1–9–09 ...... 63867 Page 93.914 Added; interim...... 52186 Chapter I Regulation at 73 FR 52186 eff. 53.1 Amended...... 18287 date delayed to 1–9–09 ...... 63867 71 Technical correction ...... 17371 93.915 Added; interim...... 52186 71.1 Amended...... 14709 Regulation at 73 FR 52186 eff. 71.3 Regulation at 73 FR 52184 eff. date delayed to 1–9–09 ...... 63867 date delayed indefinitely ...... 1 93.916 Added; interim...... 52186 (c)(6) added...... 14709 Regulation at 73 FR 52186 eff. 71.6 (a) amended...... 14709 date delayed to 1–9–09 ...... 63867 71.19 (d) introductory text 94 Technical correction ...... 20366 amended...... 14709 94.1 (a)(2) amended; interim...... 5426 71.20 (a)(3), (4), (8) and (12) amend- (a)(2) amended; eff. 1–8–09 ...... 78927 ed; (a)(17) through (20) redesig- 94.8 Introductory text amended; nated as (a)(18) through (21); interim...... 1044, 9175, 65257 new (a)(17) added; (a)(5), (6), (7), Regulation at 73 FR 1044 con- (11) and new (18) revised; OMB firmed...... 16179 number...... 14709 94.9 (e) and new Footnote 12 77.7 (b) revised; interim...... 12058 added; OMB number...... 17885 Regulation at 74 FR 12058 con- 94.11 (a) amended; interim ...... 5426 firmed...... 48376 (a) amended; eff. 1–8–09 ...... 78927 77.9 (a) and (b) revised; in- 94.12 Footnotes 12 through 18 re- terim...... 12058 designated as Footnotes 13 Regulation at 74 FR 12058 con- through 19 ...... 17885 firmed...... 48376 94.16 Footnotes 12 through 18 re- 77.11 (b)(1) revised; interim ...... 67053 designated as Footnotes 13 78.41 (a) and (b) amended; in- through 19 ...... 17885 terim...... 33140 94.17 Footnotes 12 through 18 re- Regulation at 74 FR 33140 con- designated as Footnotes 13 firmed...... 57245 through 19; newly designated 82.1 Amended...... 18287 Footnote 17 amended ...... 17885 83 Regulation at 73 FR 52184 eff. 94.18 Footnotes 12 through 18 re- date delayed indefinitely ...... 1 designated as Footnotes 13 93.300 Amended...... 31595 through 19 ...... 17885 93.303 (e) amended...... 31596 94.19 (f) revised...... 3384 93.304 (a)(1)(i) and (2) amended...... 31596

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9 CFR—Continued 74 FR 9 CFR—Continued 74 FR Page Page Chapter I—Continued Chapter I—Continued 93.308 (a)(3) footnote 14 redesig- (a)(3)(i) amended; (a)(4) redesignated as footnote 13; (b) and (c) nated as (a)(5); new (a)(4) revised; OMB number...... 31596 added; eff. 1–14–10 ...... 66221 93.309 Heading revised...... 31601 94.9 (a), (c)(3) and (e)(2) introduc- 93.310 Revised ...... 31601 tory text footnotes 10, 11 and 12 93.427 (b)(2) revised ...... 5 redesignated as footnotes 9, 10 (b)(2) introductory text revised; and 11 ...... 18288 eff. date delayed indefinitely (c)(1)(ii)(B), (iii)(C)(2), (2) and (3) ...... 5 amended; (c)(1)(iv) added; eff. 1–14–10...... 66221 (b)(2) introductory text corrected; eff. date delayed indefi- 94.11 (a) amended; eff. 1–12–10 ...... 68480 nitely ...... 22091 94.12 (b)(1)(iii)(B) footnote 13 and (3) footnote 14 redesignated as 93.900 Regulation at 73 FR 52186 (b)(1)(iii)(B) footnote 12 and (3) eff. date delayed indefi- footnote 13; new footnote 13 re- nitely ...... 1 vised...... 18288 93.901—93.906 Regulation at 73 FR (b)(1)(vi) added; eff. 1–14–10 ...... 66221 52186 eff. date delayed indefi- 94.16 (b)(2) footnote 15 redesig- nitely ...... 1 nated as (b)(2) footnote 14 ...... 18288 93.910 Regulation at 73 FR 52186 94.17 (e) footnote 16 and (p)(1)(i) eff. date delayed indefi- footnote 17 redesignated as (e) nitely ...... 1 footnote 15 and (p)(1)(i) foot- 93.911 Regulation at 73 FR 52186 note 16; new footnote 16 re- eff. date delayed indefi- vised...... 18288 nitely ...... 1 94.18 (c)(2) and (d)(1) footnotes 18 93.912 Regulation at 73 FR 52186 and 19 redesignated as foot- eff. date delayed indefi- notes 17 and 18 ...... 18288 nitely ...... 1 94.24 (a)(5) and (b)(6) footnotes 20 93.913 Regulation at 73 FR 52186 and 21 redesignated as foot- eff. date delayed indefi- notes 19 and 20 ...... 18288 nitely ...... 1 95.1 Amended; eff. 1–14–10 ...... 66226 93.914 Regulation at 73 FR 52186 95.5 Revised; eff. 1–14–10 ...... 66226 eff. date delayed indefi- 95.6 Heading, introductory text, nitely ...... 1 (a) and (c) amended; eff. 1–14– 93.915 Regulation at 73 FR 52186 10...... 66227 eff. date delayed indefi- 95.7 Footnote 1 redesignated as nitely ...... 1 Footnote 3 and revised; eff. 1– 93.916 Regulation at 73 FR 52186 14–10 ...... 66226 eff. date delayed indefi- 95.9 Footnote 1 redesignated as nitely ...... 1 Footnote 4 and revised; eff. 1– 94 Heading revised ...... 18287 14–10 ...... 66226 94.0 Amended...... 18287 95.26 Footnote 2 redesignated as 94.1 (a)(2) amended; eff. 1–12–10 ...... 68480 Footnote 5; eff. 1–14–10...... 66226 94.4 (b)(8) and (9) redesignated as 121 Regulation at 73 FR 61331 com- (b)(9) and (10); new (b)(8) added; pliance date delayed to 7–13– (b)(7) and new (9)(ii) amended; 09...... 16753 eff. 1–14–10...... 66221 121.3 Regulation at 73 FR 61331 94.6 (c)(1) introductory text, (v), compliance date delayed to 7– (viii), (ix) introductory text 13–09 ...... 16753 and (C) revised; (c)(1)(ix)(D) 121.4 Regulation at 73 FR 61331 added; OMB number...... 18287 compliance date delayed to 7– 94.8 Introductory text and (a)(4) 13–09 ...... 16753 introductory text footnotes 8 121.5 Regulation at 73 FR 61331 and 9 redesignated as footnotes compliance date delayed to 7– 7 and 8 ...... 18288 13–09 ...... 16753

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9 CFR—Continued 74 FR 9 CFR—Continued 74 FR Page Page Chapter I—Continued Chapter I—Continued 121.6 Regulation at 73 FR 61331 147.45 Amended...... 14718 compliance date delayed to 7– 147.46 (a)(9) added...... 14718 13–09 ...... 16753 147.51—147.52 (Subpart F) 121.9 Regulation at 73 FR 61332 Added ...... 14718 compliance date delayed to 7– 149.1 Amended; eff. 2–1–10 ...... 65010 13–09 ...... 16753 151.1 Correctly amended; CFR 130.1 Amended ...... 14001 130.2 Heading, (a) table and (b) correction ...... 66567 table revised; (d) removed ...... 14001 151.9 Authority citation re- 130.3 (a)(1) table revised ...... 14002 moved; CFR correction ...... 66567 (a)(1) table corrected ...... 18115 160.1 Amended; eff. 2–1–10 ...... 65010 130.4 Table revised ...... 14002 161.1 Heading, (b) and (c) revised; 130.6 (a) table revised ...... 14003 (d) through (h) added; OMB 130.7 (a) table revised ...... 14003 number; eff. 2–1–10...... 65010 130.8 (a) table revised ...... 14004 161.2 Revised; eff. 2–1–10 ...... 65011 130.10 (a) table and (b) table re- 161.3 Redesignated as 161.4; new vised...... 14004 161.3 added; eff. 2–1–10 ...... 65011 130.11 (a) table revised...... 14004 161.4 Redesignated as 161.6; new 130.20 (a) table and (b)(1) table re- 161.4 redesignated from 161.3; vised...... 14005 eff. 2–1–10 ...... 65011 130.30 (a) table and (b) table re- 161.5 Revised; eff. 2–1–10 ...... 65012 vised...... 14006 161.6 Redesignated from 161.4; 145.1 Amended ...... 14714 heading and (a) revised; (b), (c) 145.2 (a) amended ...... 14714 and (d) redesignated as (d), (e) 145.14 (b)(5) added; (d) revised ...... 14714 and (f); new (b), (c) and (g) Heading correctly revised ...... 18116 added; eff. 2–1–10...... 65012 145.15 Revised ...... 14715 145.23 (h)(2)(i) and (ii) amend- 161.7 Added; eff. 2–1–10 ...... 65013 ed ...... 14715 162.10 Revised; eff. 2–1–10...... 65013 145.33 (l)(2)(i) and (ii) amended ...... 14715 162.12 (b), (c) and (d) redesignated (l)(2)(i) amended...... 38326 as (c), (d) and (b); eff. 2–1–10 ...... 65013 145.43 (g)(2)(i) and (ii) amended...... 14715 166.1 Amended; interim ...... 15218 145.52 (c) revised ...... 14715 Regulation at 74 FR 15218 con- 145.63 (b) added ...... 14715 firmed...... 65014 146.1 Amended ...... 14715 166.2 (a) amended; interim ...... 15218 146.2 (a) amended ...... 14716 Regulation at 74 FR 15218 con- 146.3 (a) revised; (c) amended...... 14716 firmed...... 65014 146.6 Revised ...... 14716 146.9 (a) amended ...... 14716 146.11 (a) revised; (b) and (c) redes- 2010 ignated as (d) and (e); new (b) 9 CFR 75 FR and (c) added...... 14716 Page 146.13 (b) revised ...... 14716 Chapter I 146.43 (a)(1) amended...... 14717 53.4 Regulation at 71 FR 56323 con- 146.51—146.53 (Subpart E) firmed ...... 10656 Added ...... 14717 53.8 Regulation at 71 FR 56323 con- 147.9 (a)(4)(i)(F) revised; Figure 1 firmed ...... 10656 removed; Figures 2 and 3 redesignated as Figures 1 and 2 ...... 14718 53.11 Regulation at 71 FR 56323 147.12 Amended...... 14718 confirmed...... 10656 147.14 Amended...... 14718 56 Regulation at 71 FR 56323 con- 147.15 Amended...... 14718 firmed ...... 10656 147.16 Amended...... 14718 56.1 Amended...... 10656 147.30 Amended...... 14718 56.2 (a)(2), (3) and (c) amended...... 10656 147.31 Added ...... 14718 56.3 (b)(7) revised ...... 10657 147.43 (d)(4) revised; (d)(6) amend- 56.4 (a)(2) and (c)(2) amended; ed ...... 14718 OMB number ...... 10657

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9 CFR—Continued 75 FR 9 CFR—Continued 75 FR Page Page Chapter I—Continued Chapter I—Continued 56.5 (a)(7), (8), (d) introductory 113.113 (a)(2), (3), (c)(1)(iv) and text and (2)(i) amended; (a)(9) (2)(iv)(A) amended ...... 20773 added; (c)(2), (d)(1)(iii), (2)(ii) Regulation at 75 FR 20773 effec- and (iii) revised...... 10657 tive date confirmed ...... 40719 56.6 OMB number ...... 10657 113.209 (b)(1) amended ...... 20773 56.7 OMB number ...... 10657 Regulation at 75 FR 20773 effec- 56.8 (a)(2) amended; (c) and (d) re- tive date confirmed ...... 40719 designated as (d) and (e); new 114.8 (c) revised...... 20773 (c) added ...... 10657 Regulation at 75 FR 20773 effec- 56.9 OMB number ...... 10657 tive date confirmed ...... 40719 56.10 (a) introductory text re- 114.9 (a)(1), (5) and (7) amended ...... 20773 vised...... 10658 Regulation at 75 FR 20773 effec- 77.7 (b)(3) added; interim ...... 60588 tive date confirmed ...... 40719 77.9 (b)(2) revised; interim...... 60588 116.5 (b) amended ...... 20773 77.11 (b)(2) removed; interim ...... 60588 Regulation at 75 FR 20773 effec- 78.1 Amended; interim ...... 81094 tive date confirmed ...... 40719 91.3 (a) amended...... 57658 124.22 (a) amended ...... 20773 94.1 Regulation at 74 FR 68480 eff. Regulation at 75 FR 20773 effec- date delayed indefinitely...... 1697 tive date confirmed ...... 40719 (a)(2) and (3) amended; interim 124.40 (b)(3) amended...... 20773 ...... 65432 Regulation at 75 FR 20773 effec- (a)(2) amended...... 69857 tive date confirmed ...... 40719 94.8 Introductory text amend- 145 Regulation at 71 FR 56328 con- ed ...... 69857 firmed ...... 10656 94.9 (a) amended...... 69857 146 Regulation at 71 FR 56328 con- 94.10 (a) amended ...... 69857 firmed ...... 10656 94.11 Regulation at 74 FR 68480 eff. 146.1 Amended ...... 10658 date delayed indefinitely...... 1697 146.2 (f) amended...... 10658 (a) amended; interim...... 65432 146.4 OMB number ...... 10658 (a) amended ...... 69857 146.11 OMB number ...... 10658 94.12 (a) amended ...... 69857 146.13 OMB number ...... 10658 146.14 OMB number ...... 10658 94.27 Introductory text amended; 146.24 OMB number ...... 10658 interim...... 65432 146.44 OMB number ...... 10658 102.3 (b)(2)(i) amended...... 20772 147.8 Regulation at 71 FR 56333 Regulation at 75 FR 20772 effec- confirmed...... 10656 tive date confirmed ...... 40719 147.45 Regulation at 71 FR 56333 102.5 (e) amended ...... 20772 confirmed...... 10656 Regulation at 75 FR 20772 effec- 147.46 Regulation at 71 FR 56333 tive date confirmed ...... 40719 confirmed...... 10656 103.3 (d) amended ...... 20772 161 Policy statement ...... 59605 Regulation at 75 FR 20772 effec- 162.11 Amended...... 57658 tive date confirmed ...... 40719 162.12 (a) amended...... 57659 104.3 (a) amended ...... 20772 Regulation at 75 FR 20772 effective date confirmed ...... 40719 2011 104.5 (a)(1) and (4) amended...... 20772 9 CFR 76 FR Regulation at 75 FR 20772 effec- Page tive date confirmed ...... 40719 Chapter I 108.7 Amended ...... 20772 56.1 Amended...... 15792 Regulation at 75 FR 20772 effec- 56.3 (b) introductory text amend- tive date confirmed ...... 40719 ed; (b)(1) and (2) revised; (b)(4), 112.5 (a), (d)(1)(iii) and (iv) amend- (5) and (6) removed; (b)(7) redes- ed ...... 20772 ignated as (b)(3) ...... 15792 Regulation at 75 FR 20772 effec- First (b)(3) correctly removed ...... 65935 tive date confirmed ...... 40719 77.7 (b)(1) revised; interim...... 56636

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9 CFR—Continued 76 FR 9 CFR—Continued 76 FR Page Page Chapter I—Continued Chapter I—Continued (a) amended; (b)(2) removed; in- Regulation at 76 FR 16685 en- terim ...... 61253 forcement delayed indefinitely (a) amended; (b)(3) removed; in- ...... 52547 terim ...... 61254 93.500 Amended...... 70039 77.9 (b)(1) revised; interim...... 56636 93.505 (a) amended ...... 70039 (b)(3) removed; interim ...... 61253 94.0 Amended...... 70039 94.1 (a)(2) amended...... 70039 (b)(2) removed; interim ...... 61254 94.6 Amended; heading, (a) and (b) 77.11 (b)(1) revised; interim ...... 56636 revised; (d) and (e) removed; (f) 78.1 Regulation at 75 FR 81094 redesignated as new (d); in- comment period extended ...... 6322 terim ...... 4054 78.43 Amended; interim ...... 28886 Regulation at 76 FR 4054 com- Regulation at 76 FR 28886 con- ment period reopened...... 24793 firmed...... 65936 94.8 Amended; interim ...... 4054 88.1 Amended...... 55216 Regulation at 76 FR 4054 com- 88.2 (b) amended...... 55216 ment period reopened...... 24793 88.3 (a) introductory text and (b) 94.9 Amended; interim ...... 4054, 4055 amended...... 55216 Regulation at 76 FR 4054 and 4055 88.4 (a) introductory text, (3) in- comment period reopened ...... 24793 troductory text, (b) introduc- (b) and (c) introductory text tory text, (4), (c), (d) and (e) amended ...... 70039 amended; OMB number ...... 55216 94.10 (b) and (c) amended ...... 70039 91.6 (a)(4) revised ...... 29992 94.11 (a) amended ...... 70039 91.9 Revised ...... 29992 94.12 Amended; interim ...... 4054, 4055 91.14 (a), (b) and (d) revised ...... 18348 Regulation at 76 FR 4054 and 4055 91.15 (a) revised...... 18348 comment period reopened ...... 24793 93.101 (a), (c)(2)(i) introductory (a) amended ...... 70039 text, (ii) introductory text, 94.13 Introductory text amend- (E)(2)(ii), (3) introductory text, ed ...... 15211, 70039 (f)(2) introductory text, 94.16 Amended; interim ...... 4054 (iii)(B)(2) and (3) amended; in- Regulation at 76 FR 4054 com- terim ...... 4053 ment period reopened...... 24793 94.17 Amended; interim ...... 4054, 4055 Regulation at 76 FR 4053 com- Regulation at 76 FR 4054 and 4055 ment period reopened...... 24793 comment period reopened ...... 24793 93.104 (b)(4), (6), (c)(5) and (7) 94.18 Amended; interim ...... 4054 amended; interim...... 4053 Regulation at 76 FR 4054 com- Regulation at 76 FR 4053 comment period reopened...... 24793 ment period reopened...... 24793 94.24 Amended; interim ...... 4054 93.201 (a), (c)(2) and (3) amended; Regulation at 76 FR 4054 com- interim ...... 4053 ment period reopened...... 24793 Regulation at 76 FR 4053 com- Heading, (a) introductory text, ment period reopened...... 24793 (1)(i), (ii), (iii), (5), (b) introduc- 93.205 Revised; interim...... 4053 tory text, (2)(i), (ii), (iii) and (6) Regulation at 76 Fr 4053 com- amended ...... 70039 ment period reopened...... 24793 94.25 (a) amended ...... 15211 93.209 (b) amended; interim ...... 4054 94.26 Introductory text, (b) intro- Regulation at 76 FR 4054 com- ductory text, (c)(1) and (4) ment period reopened...... 24793 amended; interim...... 4055 93.301 (c)(2)(iii), (d)(1)(ii)(D), Regulation at 76 FR 4055 com- (e)(3)(i) introductory text, (B), ment period reopened...... 24793 (4)(ii), (5)(i) and (f)(3) revised; 95.5 Introductory text revised; (e)(1)(iii) amended; interim...... 16685 (b)(1) amended ...... 28887 Regulation at 76 FR 16685 en- 95.6 Introductory text revised...... 28887 forcement delayed to 7–25–11; 95.30 Heading and (a) amended; interim ...... 31220 interim ...... 4055

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9 CFR—Continued 76 FR 9 CFR—Continued 76 FR Page Page Chapter I—Continued Chapter I—Continued Regulation at 76 FR 4055 com- 146.53 (a)(1), (2) and (b) amendment period reopened...... 24793 ed ...... 15797 98.30 Amended ...... 70039 147.5 (b) footnote 4 amended ...... 15797 98.38 Heading, introductory text, 147.6 Introductory text and (a)(1) (a), (b)(1), (2), (3) and (i) amend- through (4) revised; (a)(5) ed ...... 70040 through (15) removed ...... 15797 145.1 Amended ...... 15792 147.12 Amended; (a)(3) footnote 8 145.10 Introductory text revised; and (c)(3)(ii)(A) new footnote 10 (r) and (t) amended...... 15792 amended; (a)(6) and new foot- 145.14 Introductory text and (b)(2) note 9 added ...... 15797 amended; (b) heading, (1) and 147.14 Amended...... 15797 (5) revised; (c) removed...... 15792 147.15 Amended...... 15797 145.23 (b)(2)(iii) and (h) introduc- 147.16 Amended...... 15797 tory text amended; (h)(1) 147.30 Amended...... 15797 added; (h)(2) revised ...... 15793 147.31 Amended...... 15797 145.24 (a)(1)(i) amended ...... 15793 147.45 Amended...... 15797 145.33 (b)(2)(iii) and (l) introduc- 147.52 (c) added...... 15798 tory text amended; (l)(1) added; 161.3 (d) amended ...... 52549 (l)(2) revised ...... 15793 145.34 (a)(1)(i) amended ...... 15793 2012 145.43 (b)(2)(iii), (g) introductory 9 CFR 77 FR text, (1)(i) and (2)(i) amended; Page (d)(2) and (3) removed; (f)(5) Chapter I footnote 6 and (g)(3) redesig- 2.38 (i)(4) and (l) added; eff. 1–30– nated as (f)(5) footnote 5 and 13...... 76823 (g)(4); (g)(1) introductory text 2.102 (a)(4) and (b)(3) added; eff. 1– and (2) introductory text re- 30–13 ...... 76823 vised; new (g)(3) added...... 15793 2.126 Heading revised; (c) added; 145.44 (a)(1)(i) amended ...... 15793 OMB number; eff. 1–30–13...... 76814 145.51—145.54 (Subpart E) Head- 2.134 Added; eff. 1–30–13 ...... 76823 ing revised ...... 15793 3.101 (b) amended; eff. 1–30–13 ...... 76824 145.52 Introductory text re- 11.7 (g) amended...... 33618 vised...... 15793 11.21 Heading and (d) revised ...... 33618 Technical correction ...... 22295 11.25 Added ...... 33618 145.53 (b)(2)(iii), (5), (e) introduc- 55 Regulation at 71 FR 41701 eff. 8– tory text, (1) introductory text 13–12; authority citation re- and (2) introductory text vised...... 35565 amended; (e)(3) added...... 15794 Regulation at 77 FR 35565 com- 145.54 (a)(1)(i) amended ...... 15794 ment period reopened...... 42625 145.73 (f) introductory text 55.1 Regulation at 71 FR 41701 eff. amended; (f)(1) revised; (f)(2) 8–13–12 ...... 35565 added...... 15794 Amended; interim...... 35565 145.83 (f)(1)(vi), (vii) and (g) intro- Regulation at 77 FR 35565 com- ductory text amended; ment period reopened...... 42625 (f)(1)(viii) and (g)(2) added; 55.21—55.25 (Subpart B) Regula- (g)(1) revised...... 15794 tion at 71 FR 41702 eff. 8–13– 145.91—145.94 (Subpart I) 12...... 35565 Added ...... 15794 Revised; interim ...... 35566 146.1 Amended ...... 15796 Regulation at 77 FR 35566 com- 146.9 Introductory text revised .....15796 ment period reopened...... 42625 146.21 Amended...... 15796 77.9 (a) correctly revised ...... 16661 146.23 (a) revised ...... 15796 81 Regulation at 71 FR 41705 eff. 8– 146.24 (a)(1)(i), (iii), (iv) and (v) 13–12 ...... 35565 amended...... 15797 Revised; interim ...... 35569 146.33 (a)(1) and (2) amended ...... 15797 92.2 (d) amended; (e) and (f) re- 146.43 (a)(1) amended...... 15797 vised ...... 1389

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9 CFR—Continued 77 FR 9 CFR—Continued 77 FR Page Page Chapter I—Continued Chapter I—Continued (a) through (f) revised...... 44109 Regulation at 76 FR 4054 and 4055 92.4 Revised ...... 1389 comment period reopened ...... 34783 93.101 Regulation at 76 FR 4053 94.13 Introductory text, (a) and comment period reopened...... 34783 (b) redesignated as (a), (b) and 93.104 Regulation at 76 FR 4053 (c); new (a) and new (c)(1) re- comment period reopened...... 34783 vised; new (c)(2) amended...... 1394 93.201 Regulation at 76 FR 4053 94.14 (a) amended...... 1394 comment period reopened...... 34783 94.16 (b) introductory text, (c) in- 93.205 Regulation at 76 FR 4053 troductory text and (d) revised; comment period reopened...... 34783 (b)(2) footnote 15 redesignated 93.209 Regulation at 76 FR 4054 as footnote 14 ...... 1394 comment period reopened...... 34783 93.301 (c)(1), (h)(6), (7) and (j) in- Regulation at 76 FR 4054 com- troductory text revised; ment period reopened...... 34783 (c)(2)(ix), (d)(3), (e)(1) introduc- 94.17 (e) footnote 16 and (p)(1)(i) tory text, (2)(i), (f)(10)(i), (g) in- footnote 17 redesignated as troductory text and (h) intro- footnotes 15 and 16; new (p)(1)(i) ductory text amended ...... 1390 footnote 16 revised...... 1395 93.308 (a)(1) and (2) revised ...... 1390 Regulation at 76 FR 4054 and 4055 93.405 (a)(3) introductory text re- comment period reopened ...... 34783 vised ...... 1391 94.18 (c)(2) footnote 18 and (d)(1) 93.500 Amended ...... 1391 footnote 19 redesignated as 93.505 (a) amended; (b) introduc- footnotes 17 and 18 ...... 1395 tory text revised...... 1391 Regulation at 76 FR 4054 com- 93.600 (a) introductory text re- ment period reopened...... 34783 vised ...... 1391 94.24 (a)(1)(i) and (b)(2)(i) amend- 94.0 Amended ...... 1392 ed; (a)(5) footnote 20 and (b)(6) 94.1 (a) revised...... 1392 footnote 21 redesignated as 94.2 Amended ...... 1392 footnotes 19 and 20 ...... 1395 94.6 Regulation at 76 FR 4054 com- Regulation at 76 FR 4054 comment period reopened ...... 34783 ment period reopened...... 34783 94.8 (a), (b) and (c) redesignated as 94.25 Introductory text removed; (b), (c) and (d); introductory (a) revised; (b) introductory text removed; new (a) added; text, (1), (2), (3), (c) introduc- new (b)(3)(i), (4) introductory tory text and (1) through (5) text, (5) introductory text and amended ...... 1395 new (c) amended ...... 1392 94.26 Regulation at 76 FR 4055 Regulation at 76 FR 4054 com- comment period reopened...... 34783 ment period reopened...... 34783 95.30 Regulation at 76 FR 4055 94.9 (a) revised; (c)(1)(iii)(C)( ) 1 comment period reopened...... 34783 and (2) amended; footnote 9 96.2 (a) introductory text, (1), (2) added; footnote 10 removed; and (5) amended...... 1395 footnotes 11 and 12 redesignated as new footnotes 10 and 98.3 Introductory text amend- 11 ...... 1393 ed...... 1396 Regulation at 76 FR 4054 and 4055 98.30 Amended...... 1396 comment period reopened ...... 34783 98.38 Introductory text and (b)(1) 94.10 (a) revised ...... 1393 amended ...... 1396 94.11 (a) revised; (c) introductory (h) removed; (i) redesignated as text, (1), (2) and (3) amend- new (h); introductory text and ed...... 1393 new (h) amended; eff. 1–16–13 94.12 Footnotes 13 and 14 redesig- ...... 74558 nated as footnotes 12 and 13; (a) 121.1 Amended ...... 61077 and new (b)(3) footnote 13 re- 121.3 (a), (c) introductory text, (2) vised; (b)(1)(iv)(B)(1), (2)(i), and and (f)(3)(i) amended; (b) and (ii) amended ...... 1394 (e) revised; (d)(3) added...... 61077

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9 CFR—Continued 77 FR 9 CFR—Continued 77 FR Page Page Chapter I—Continued Chapter I—Continued 121.4 (a), (c) introductory text, (2) 121.12 (a) and (c)(1) revised; (c)(2) introductory text and (f)(3)(i) and (3) amended; (d) redesig- amended; (b) and (e) revised; nated as (e); new (d) added; eff. (d)(3) added ...... 61078 4–3–13...... 61080 121.5 (a)(3)(i) amended...... 61078 121.13 Footnote 10 removed; (a) and (b) revised...... 61080 121.6 (a)(3)(i) amended; (e) re- 121.14 Heading and (a) amended; vised...... 61078 (b) revised; (c) and (d) redesig- 121.9 (a)(4), (b) and (c)(1) amended; nated as (d) and (f); new (c) and (a)(5) redesignated as (a)(6); (e) added; eff. 4–3–13 ...... 61080 new (a)(5) added ...... 61078 121.15 Revised; eff. 4–3–13...... 61081 121.10 (e) through (j) redesignated 121.16 Footnote 14 and (f) through as (f) through (k); new (e) (i) redesignated as footnote 12 added; new (j) amended ...... 61079 and (i), (j), (k) and (g); new (f) 121.11 (c)(6) amended; (e) and (f) and (h) added; new (g) amend- redesignated as (g) and (h); (b), ed ...... 61081 (c)(2) and new (g) revised; (c)(8), 121.17 (a)(1) introductory text re- (9), (10), new (e) and new (f) vised; (a)(2) through (6) redes- added; eff. 4–3–13...... 61079 ignated as (a)(3) through (7); new (a)(2) added ...... 61081 121.20 Revised ...... 61081 Æ

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