Subtitle B—Regulations of the Department of Agriculture (Continued)
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SUBCHAPTER C—REGULATIONS AND STANDARDS UNDER THE AGRICUL- TURAL MARKETING ACT OF 1946 AND THE EGG PRODUCTS INSPECTION ACT—(CONTINUED)
Part Page 53 Livestock (grading, certification, and standards) ... 7 54 Meats, prepared meats, and meat products (grad- ing, certification, and standards) ...... 13 55 Voluntary inspection of egg products and grading 32 56 Voluntary grading of shell eggs ...... 48 57 Inspection of eggs (Egg Products Inspection Act) ... 68 58 Grading and inspection, general specifications for approved plants and standards for grades of dairy products ...... 85 59 Livestock mandatory reporting ...... 161 60 [Reserved] 61 Cottonseed sold or offered for sale for crushing purposes (inspection, sampling and certification) 174 70 Voluntary grading of poultry products and rabbit products ...... 180 75 Regulations for inspection and certification of quality of agricultural and vegetable seeds ...... 200
SUBCHAPTER D—EXPORT AND DOMESTIC CONSUMPTION PROGRAMS 80 Fresh Irish potatoes ...... 207 81 [Reserved]
SUBCHAPTER E—COMMODITY LABORATORY TESTING PROGRAMS 90 Introduction ...... 211 91 Services and general information ...... 213
1 Including matters within the responsibilities of the Federal Grain Inspection Service.
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92 Tobacco ...... 228 93 Processed fruits and vegetables ...... 231 94 Poultry and egg products ...... 234 95 [Reserved] 96 Cottonseed sold or offered for sale for crushing purposes (chemical analysis and United States official grade certification) ...... 238 97 Plant variety and protection ...... 246 98 Meals, Ready-to-Eat (MRE’s), meats, and meat products ...... 265 99–109 [Reserved] 110 Recordkeeping on restricted use pesticides by cer- tified applicators; surveys and reports ...... 268 111–159 [Reserved]
SUBCHAPTER F—NAVAL STORES 160 Regulations and standards for naval stores ...... 280
SUBCHAPTERS G–H [RESERVED]
SUBCHAPTER K—FEDERAL SEED ACT 201 Federal Seed Act regulations ...... 298 202 Federal Seed Act rules of practice ...... 372 203–204 [Reserved]
SUBCHAPTER L—REQUIREMENTS RELATING TO PURCHASES [RESERVED]
SUBCHAPTER M—ORGANIC FOODS PRODUCTION ACT PROVISIONS 205 NATIONAL ORGANIC PROGRAM ...... 376 206–209 [Reserved]
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PART 53—LIVESTOCK (GRADING, may demand. For the purposes of such CERTIFICATION, AND STANDARDS) regulations, unless the context other- wise requires, the following terms shall Subpart A—Regulations be construed, respectively, to mean: Acceptance service. The service estab- DEFINITIONS lished and conducted under the regula- Sec. tions for the determination and certifi- 53.1 Meaning of words. cation or other identification of the 53.2 Designation of official certificates, compliance of livestock with specifica- memoranda, marks, other identifica- tions. tions, for purposes of the Agricultural Act. The Agricultural Marketing Act Marketing Act. of 1946 (Title II of the act of Congress ADMINISTRATION approved August 14, 1946, 60 Stat. 1087, as amended by Pub. L. 272, 84th Cong., 53.3 Authority. 69 Stat. 553, 7 U.S.C. 1621–1627). SERVICE Administrator. The Administrator of 53.4 Kind of service. the Agricultural Marketing Service, or 53.5 Availability of service. any officer or employee of the Agricul- 53.8 How to obtain service. tural Marketing Service to whom au- 53.9 Order of furnishing service. thority has heretofore been delegated, 53.10 When request for service deemed or to whom authority may hereafter be made. delegated, to act in his stead. 53.11 Withdrawal of application or request Agricultural Marketing Service. The for service. 53.12 Authority of agent. Agricultural Marketing Service of the 53.13 Denial or withdrawal of service. Department. 53.14 Financial interest of official grader. Applicant. Any person who has ap- 53.15 Accessibility to livestock. plied for service under the regulations. 53.16 Official certificates. Branch. The Livestock Market News 53.17 Advance information concerning serv- Branch of the Division. ice rendered. Chief. The Chief of the Branch, or any CHARGES FOR SERVICE officer or employee of the Branch to whom authority has heretofore been 53.18 Fees and other charges for service. delegated, or to whom authority may 53.19 Payment of fees and other charges. hereafter be delegated, to act in his MISCELLANEOUS stead. 53.20 Identification. Class. A subdivision of livestock 53.21 Errors in service. based on essential physical character- istics that differentiate between major Subpart B [Reserved] groups of the same kind of species. Compliance. Conformity of livestock to the specifications under which the AUTHORITY: 7 U.S.C. 1621–1627. livestock was purchased or sold, with SOURCE: 42 FR 53902, Oct. 4, 1977, unless particular reference to the weight, otherwise noted. quality or other characterics of live- stock. Subpart A—Regulations Cooperative agreement. A cooperative agreement between the Agricultural DEFINITIONS Marketing Service and another Federal agency or a State agency, or other § 53.1 Meaning of words. agency, organization or person as spec- Words used in this subpart in the sin- ified in the Agricultural Marketing Act gular form shall be deemed to import of 1946, as amended, for conducting the the plural, and vice versa, as the case service.
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Department. The United States De- States Standards for Grades of: Carcass partment of Agriculture. Beef; Veal and Calf Carcasses; Lamb, Director. The Director of the Division Yearling Mutton, and Mutton Car- or any officer or employee of the Divi- casses; and, Pork Carcasses. sion to whom authority has heretofore Supervisor. An official person des- been delegated, or to whom authority ignated by the Director or Chief to su- may hereafter be delegated, to act in pervise and maintain uniformity and his stead. accuracy of service under the regula- Division. Livestock, Poultry, Grain tions. and Seed Division. Financially interested person. Any per- [42 FR 53902, Oct. 4, 1977, as amended at 63 FR son having a financial interest in the 72101, Dec. 31, 1998] livestock involved, including but not § 53.2 Designation of official certifi- limited to the shipper, receiver, pro- cates, memoranda, marks, other ducer, seller, buyer, or carrier of the identifications, for purposes of the livestock or products. Agricultural Marketing Act. Grade. (1) As a noun, this term means an important commercial subdivision Subsection 203(h) of the Agricultural of livestock based on certain definite Marketing Act of 1946, as amended by and preference determining factors, Pub. L. 272, 84th Congress, provides such as, but not limited to, conforma- criminal penalties for various specified tion, finish, and muscling in livestock. offenses relating to official certifi- (2) As a verb, this term means to de- cates, memoranda, marks or other termine the class, grade, or other qual- identifications, and devices for making ity of livestock according to applicable such marks or identifications, issued or standards for such livestock. authorized under section 203 of said Grading service. The service estab- act, and certain misrepresentations lished and conducted under the regula- concerning the inspection or grading of tions for the determination and certifi- agricultural products under said sec- cation or other identification of the tion. For the purposes of said sub- class, grade, or other quality of live- section and the provisions in this part, stock under standards. the terms listed below shall have the Legal holiday. Those days designated respective meanings specified: as legal public holidays in title 5, (a) Official certificate means any form United States Code, section 6103(a). of certification, either written or print- Livestock. Cattle, sheep, swine, or ed, including that prescribed in § 53.16, goats. used under the regulations to certify Official grader. An employee of the with respect to the inspection, class, Department or other person authorized grade, quality, size, quantity, or condi- by the Department to determine and tion of livestock with applicable speci- certify or otherwise identify the class, fications. grade, other quality, or compliance of (b) Official memorandum means any livestock under the regulations. initial record of findings made by an Person. Any individual, partnership, authorized person in the process of corporation, or other legal entity, or grading, determining compliance, or Government agency. inspecting, pursuant to the regula- Regulations. The regulations in this tions, any processing or plant–oper- subpart. ation report made by an authorized Service. Grading service or acceptance person in connection with grading, de- service. termining compliance, inspecting, or Specifications. Description with re- sampling under the regulations, and spect to the class, grade, other quality, any report made by an authorized per- quantity or condition of livestock ap- son of services performed pursuant to proved by the Administrator, and the regulations. available for use by the industry re- (c) Official mark or other official identi- gardless of the origin of the descrip- fication means any form of mark or tions. other identification, used under the Standards. The standards of the De- regulations in marking livestock partment contained in Official United thereof, to show inspection, class,
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grade, quality, size, quantity, or condi- nancially interested. The application tion of the livestock (including the shall be made on a form approved by compliance of livestock with applicable the Director. specifications), or to maintain the (b) Notice of eligibility for service. The identity of livestock for which service applicant for service will be notified is provided under the regulations. whether his application is approved. (c) Request by applicant for service— ADMINISTRATION (1) Noncommitment. Upon notification of the approval on an application for serv- § 53.3 Authority. ice, the applicant may, from time to The Director is charged with the ad- time as desired, make oral or written ministration of the regulations and the requests for service under the regula- Act insofar as they relate to livestock. tions with respect to specific livestock for which the service is to be furnished SERVICE under such application. Such requests § 53.4 Kind of service. shall be made at a market news office either directly or through any em- Grading service under the regula- ployee of the Agricultural Marketing tions shall consist of the determination Service who may be designated for and certification and other identifica- such purposes. tion, upon request by the applicant, of the class, grade, or other quality of § 53.9 Order of furnishing service. livestock under applicable standards. Service under the regulations shall Class, grade and other quality may be be furnished to applicants in the order determined under said standards for in which requests therefor are received, livestock. Acceptance service under insofar as consistent with good man- the regulations shall consist of the de- agement, efficiency and economy. termination of the conformity of live- Precedence will be given, when nec- stock to specifications approved by the essary, to requests made by any gov- Director or Chief and the certification ernment agency or any regular user of and other identification of such live- the service. stock in accordance with specifica- tions, upon request by the applicant. § 53.10 When request for service [42 FR 53902, Oct. 4, 1977, as amended at 63 FR deemed made. 72101, Dec. 31, 1998] A request for service under the regu- lations shall be deemed to be made § 53.5 Availability of service. when received by a market news office. Service under these regulations may Records showing the date and time of be made available with respect to live- the request shall be made and kept in stock shipped or received in interstate such office. commerce, and with respect to the livestock not so shipped or received if § 53.11 Withdrawal of application or the Director or Chief determines that request for service. the furnishing of service for such live- An application or a request for serv- stock would facilitate the marketing, ice under the regulations may be with- distribution, processing, or utilization drawn by the applicant at any time be- of agricultural products through com- fore the application is approved or mercial channels. Also, such service prior to performance of service, upon may be made available under a cooper- payment, in accordance with §§ 53.18 ative agreement. Service under these and 53.19, of any expenses already in- regulations shall be provided without curred by the Agricultural Marketing discrimination as to race, color, sex, Service in connection therewith. creed, or national origin. § 53.12 Authority of agent. § 53.8 How to obtain service. Proof of the authority of any person (a) Application. Any person may apply making an application or a request for to the Director or Chief for service service under the regulations on behalf under the regulations with respect to of any other person may be required at livestock in which the applicant is fi- the discretion of the Director or Chief
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or the official in charge of the market tive features under supervision of the news office or other employee receiving Director or Chief: And provided, further, the application or request under § 53.8. That paragraph (a)(1)(ii) through (vi) of this section shall not be deemed to be § 53.13 Denial or withdrawal of serv- violated by any act committed by any ice. person prior to the making of an appli- (a) For misconduct—(1) Bases for denial cation for service under the regulations or withdrawal. An application or a re- by the principal person. An application quest for service may be rejected, or or a request for service may be re- the benefits of the service may be oth- jected, or the benefits of the service erwise denied to, or withdrawn from, may be otherwise denied to, or with- any person who, or whose employee or drawn from, any person who, or whose agent in the scope of his employment employee or agent in the scope of his or agency: (i) Has willfully made any employment or agency, has committed misrepresentation or has committed any of the offenses specified in para- any other fraudulent or deceptive prac- graph (a)(1) (i) through (vii) of this sec- tice in connection with any application tion after such application was made. or request for service under the regula- Moreover, an application or a request tions; (ii) has given or attempted to for service made in the name of a per- give, as a loan or for any other pur- son otherwise eligible for service under pose, any money, favor, or other thing the regulations may be rejected, or the of value, to any employee of the De- benefits of the service may be other- partment authorized to perform any wise denied to, or withdrawn from, function under the regulations; (iii) has such a person (a) in case the service is interfered with or obstructed, or at- or would be performed at an establish- tempted to interfere with or to ob- ment operated (1) by a corporation, struct, any employee of the Depart- partnership, or other person from ment in the performance of his duties whom the benefits of the service are under the regulations by intimidation, currently being withheld under this threats, assaults, abuse, or any other paragraph, or (2) by a corporation, improper means; (iv) has knowingly partnership, or other person having an falsely made, issued, altered, forged, or officer, director, partner, or substan- counterfeited any official certificate, tial investor from whom the benefits of memorandum, mark, or other identi- the service are currently being with- fication; (v) has knowingly uttered, held and who has any authority with published, or used as true any such respect to the establishment where falsely made, issued, altered, forged, or service is or would be performed, or (b) counterfeited certificate, memo- in case the service is or would be per- randum, mark, identification, or de- formed with respect to any livestock in vice; (vi) has knowingly obtained or re- which any corporation, partnership, or tained possession of any such falsely other person within paragraph made, issued, altered, forged, or coun- (a)(1)(vii)(a)(1) of this section has a terfeited certificate, memorandum, contract or other financial interest. mark, identification, or device, or of (2) Procedure. All cases arising under any livestock bearing any such falsely this paragraph shall be conducted in made, issued, altered, forged, or coun- accordance with the Rules of Practice terfeited mark or identification; or Governing Formal Adjudicatory Pro- (vii) has in any manner not specified in ceedings Instituted by the Secretary this paragraph violated subsection Under Various Statutes set forth in 203(h) of the Act: Provided, That para- §§ 1.130 through 1.151 of this title and graph (a)(1)(vi) of this section shall not the Supplemental Rules of Practice in be deemed to be violated if the person part 50 of this chapter. in possession of any item mentioned (b) For miscellaneous reasons. An ap- therein notifies the Director or Chief plication or a request for service may without delay that he has possession of be rejected, or the benefits of the serv- such item and, surrenders it to the Di- ice may be otherwise denied to, or rector or Chief or destroys it or brings withdrawn from, any person, without a it into compliance with the regulations hearing, by the official in charge of the by obliterating or removing the viola- appropriate market news office with
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the concurrence of the Director or ined for compliance with specifica- Chief: (1) For administrative reasons tions. such as the nonavailability of per- (b) [Reserved] sonnel to perform the service; (2) for the failure to pay for service; (3) for § 53.16 Official certificates. other noncompliance with the condi- (a) Required; exception. The official tions on which service is available as grader shall prepare, sign, and issue a provided in the regulations, except livestock acceptance certificate cov- matters covered by paragraph (a) of ering livestock for which compliance this section; or (4) in case the person is has been determined. a partnership, corporation, or other (b) Where weight is certified, the person from whom the benefits of the word ‘‘Not’’ shall be deleted from the service are currently being withheld phrases ‘‘Weights Not Verified.’’ under paragraph (a) of this section. No- (c) Distribution. The original certifi- tice of such denial or withdrawal, and cate, and not to exceed two copies, the reasons therefor, shall promptly be shall be delivered or mailed to the ap- given to the person involved. plicant or other person designated by (c) Filing of records. The final orders him. The remaining copies shall be for- in formal proceedings under paragraph warded as required by agency, division, (a) of this section to deny or withdraw and branch instructions. Additional the service under the regulations (ex- copies will be furnished to any person cept orders required for good cause to financially interested in livestock in- be held confidential and not cited as volved with the concurrence of the ap- precedents) and other records in such plicant and upon payment of fees, as proceedings (except those required for provided in § 53.18(d). good cause to be held confidential) shall be filed with the Hearing Clerk § 53.17 Advance information con- and shall be available for inspection by cerning service rendered. persons having a proper interest there- Upon request of any applicant, all or in. any part of the contents of any certifi- cate issued to him under the regula- [42 FR 53902, Oct. 4, 1977, as amended at 60 FR 8464, Feb. 14, 1995] tions, or other notification concerning the determination of class, grade, other § 53.14 Financial interest of official quality, or compliance of livestock for grader. such applicant may be transmitted by telegraph or telephone to him, or to No official grader shall grade or de- any person designated by him, at his termine compliance of any livestock in expense. which he or any of his relatives by blood or marriage is directly or indi- CHARGES FOR SERVICE rectly financially interested. § 53.18 Fees and other charges for § 53.15 Accessibility to livestock. service. (a) The applicant shall cause live- Fees and other charges equal as near- stock, with respect to which service is ly as may be to the cost of the services requested, to be made easily accessible rendered shall be assessed and col- for examination and to be so placed, lected from applicants in accordance with adequate illuminating facilities, with the following provisions unless as to disclose their class, grade, other otherwise provided in the cooperative quality, and compliance. Supervisors agreement under which the services are and other employees of the Department furnished, or as provided in § 53.8. responsible for maintaining uniformity (a) Fees based on hourly rates. Except and accuracy of service under the regu- as otherwise provided in this section, lations shall have access to all parts of fees for service shall be based on the establishments covered by approved ap- time required to render the service, plications for service under the regula- calculated to the nearest 15-minute pe- tions, for the purpose of examining all riod, including time required for the livestock in the establishments which preparation of certificates and travel have been or are to be graded or exam- of the official grader in connection
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with the performance of service. A issuance upon payment of a fee of $1.00, minimum charge for 1 hour shall be and not to exceed three copies of any made for service pursuant to each re- such certificate at any time thereafter, quest notwithstanding that the time while a copy of such certificate is on required to perform service may be less file in the Department, upon payment than 60 minutes. The base hourly rate of a fee of $5.00. shall be $29.40 per hour for work per- (e) Other charges. When costs, other formed between the hours of 6 a.m. and than costs specified in paragraphs (a), 6 p.m., Monday through Friday, except (b), (c), and (d) of this section, are in- on legal holidays; $32.80 per hour for volved in providing the services, the work performed before 6 a.m. or after 6 applicant will be charged for these p.m., Monday through Friday, and any- costs. The amount of these charges will time Saturday or Sunday except on be determined administratively by the legal holidays; and $58.80 per hour for Chief. However, the applicant will not all work performed on legal holidays. be charged for such cost without notifi- (b) Travel charges. When service is re- cation before the service is rendered of quested at a place so distant from an the charge for such item of expense. official grader’s headquarters, or place [42 FR 53902, Oct. 4, 1977, as amended at 47 FR of prior assignment on a circuitous 54927, Dec. 7, 1982; 48 FR 16874, Apr. 20, 1983] routing that a total of one-half hour or more is required for the grader to trav- § 53.19 Payment of fees and other el to such place and back to the head- charges. quarters, or to the next place of assign- Fees and other charges for service ment on a circuitous routing, the shall be paid in accordance with the charge for such service shall include a following provisions unless otherwise mileage charge administratively deter- provided in the cooperative agreement mined by the Chief, and travel tolls, if under which the service is furnished. applicable, for such travel prorated Upon receipt of billing for fees and against all the applicants furnished the other charges for service the applicant service involved on an equitable basis, shall remit by check, draft, or money or where the travel is made by public order, made payable to the Agricul- transportation (including hired vehi- tural Marketing Service, U.S.D.A., cle), a fee equal to the actual cost payment for the service in accordance thereof. However, the applicant will with directions on the billing, and such not be charged a new mileage rate fees and charges shall be paid in ad- without notification before the service vance if required by the official grader is rendered. or other authorized official. (c) Per diem charges. When service is requested at a place away from the of- MISCELLANEOUS ficial grader’s headquarters, the fee for such service shall include a per diem § 53.20 Identification. charge if the employee performing the All official graders and supervisors service is paid per diem in accordance shall have their Agricultural Mar- with existing travel regulations. Per keting Service identification cards in diem charges to applicants will cover their possession at all times while they the same period of time for which the are performing any function under the grader receives per diem reimburse- regulations and shall identify them- ment. The per diem rate will be admin- selves by such cards upon request. istratively determined by the Chief. However, the applicant will not be § 53.21 Errors in service. charged a new per diem rate without When an official grader, supervisor, notification before the service is ren- or other responsible employee of the dered. Branch has evidence of misgrading, or (d) Fees for extra copies of certificates. of incorrect certification or other in- In addition to copies of certificates fur- correct determination or identification nished under § 53.16, any financially in- as to the class, grade, other quality, or terested person may obtain not to ex- compliance of livestock, he shall report ceed three copies of any such certifi- the matter to his immediate super- cate within 1 year from its date of visor. The supervisor will investigate
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the matter and, if he deems advisable, 54.21 When request for appeal service may will report it to the owner or his agent. be withdrawn. The supervisor shall take appropriate 54.22 Denial or withdrawal of appeal service. 54.23 Who shall perform appeal service. action to correct errors found in the 54.24 Appeal certificates. determination or identification of 54.25 Superseded certificates. class, grade or other quality or compli- 54.26 Application of other regulations to ap- ance of livestock if the livestock is peal service. still owned by the person who owned them when, and are still located at the CHARGES FOR SERVICE establishment where, the incorrect 54.27 Fees and other charges for service. service was rendered and if such service 54.28 Payment of fees and other charges. was rendered by a grader under the ju- MISCELLANEOUS risdiction of such supervisor, and the supervisor shall take adequate meas- 54.29 Identification. 54.30 Errors in service. ures to prevent the recurrence of such 54.31 Uniforms. errors. Subpart B [Reserved] Subpart B [Reserved] AUTHORITY: 7 U.S.C. 1621–1627. PART 54—MEATS, PREPARED SOURCE: 42 FR 53921, Oct. 4, 1977, unless MEATS, AND MEAT PRODUCTS otherwise noted. Redesignated at 46 FR 63203, (GRADING, CERTIFICATION, AND Dec. 31, 1981. STANDARDS) Subpart A—Regulations
Subpart A—Regulations DEFINITIONS DEFINITIONS § 54.1 Meaning of words. Sec. 54.1 Meaning of words. Words used in this subpart in the sin- 54.2 Designation of official certificates, gular form shall be deemed to import memoranda, marks, other identifica- the plural, and vice versa, as the case tions, and devices for purposes of the Ag- may demand. For the purposes of such ricultural Marketing Act. regulations, unless the context other- wise requires, the following terms shall ADMINISTRATION be construed, respectively, to mean: 54.3 Authority. Administrator. The Administrator of SERVICE the Agricultural Marketing Service, or any officer or employee of the Agricul- 54.4 Kind of service. 54.5 Availability of service. tural Marketing Service to whom au- 54.6 How to obtain service. thority has heretofore been delegated 54.7 Order of furnishing service. or to whom authority may hereafter be 54.8 When request for service deemed made. delegated, to act in his stead. 54.9 Withdrawal of application or request Agricultural Marketing Service. The for service. Agricultural Marketing Service of the 54.10 Authority of agent. Department. 54.11 Denial or withdrawal of service. 54.12 Financial interest of official grader. Animals. Cattle, sheep, swine, or 54.13 Accessibility and refrigeration of prod- goats. ucts; access to establishments. Applicant. Any person who has ap- 54.14 Official certificates. plied for service under the regulations. 54.15 Advance information concerning serv- Branch. The Meat Grading Branch of ice rendered. the Division. 54.16 Marking of products. Carcass. The commercially prepared 54.17 Official identifications. or dressed body of any animal intended 54.18 Custody of identification devices. for human food. APPEAL SERVICE Carcass Data Service. The service es- 54.19 What is appeal service; marking prod- tablished and conducted under the reg- ucts on appeal; requirements for appeal; ulations to provide producers and other certain determinations not appealable. interested persons with data on carcass 54.20 Request for appeal service. characteristics.
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Certification service. The service es- ducer, seller, buyer, or carrier of the tablished and conducted under the reg- products. ulations for the determination and cer- Grade. (1) As a noun, this term means tification or other identification of the an important commercial subdivision compliance of products with specifica- of a product based on certain definite tions. and preference determining factors, Chief. The Chief of the Branch, or any such as, but not limited to, conforma- officer or employee of the Branch to tion, finish, and quality in meats. whom authority has heretofore been (2) As a verb, this term means to de- delegated, or to whom authority may termine the class, grade, or other qual- hereafter be delegated, to act in his ity of a product according to applicable stead. standards for such product. Class. A subdivision of a product Grading Service. The service estab- based on essential physical character- lished and conducted under the regula- istics that differentiate between major tions for the determination and certifi- groups of the same kind of species. cation or other identification of the Compliance. Conformity of a product class, grade, or other quality of prod- to the specifications under which the ucts under standards. product was purchased or sold, with Immediate container. The carton, can, particular reference to the quality, pot, tin, casing, wrapper, or other re- cleanliness, state of refrigeration, ceptacle or covering constituting the method of processing, and trim of prod- basic unit in which products are di- ucts. rectly contained or wrapped when Contract verification service. A pro- packed in the customary manner for gram allowing institutions or other delivery to the meat trade or to con- large purchasers of commodity prod- sumers. ucts to have those products compared Institutional Meat Purchase Specifica- to contractual requirements. tions. Specifications describing various Cooperative agreement. A cooperative meat cuts, meat products, and meat agreement between the Agricultural food products derived from all live- Marketing Service and another Federal stock species, commonly abbreviated agency or a State agency, or other ‘‘IMPS’’, and intended for use by any agency, organization or person as spec- meat procuring activity. For labeling ified in the Agricultural Marketing Act purposes, only product certified by the of 1946, as amended, for conducting the Meat Grading and Certification Branch service. may contain the letters ‘‘IMPS’’ on the Department. The United States De- product label. partment of Agriculture. Legal Holiday. Those days designated Director. The Director of the Division, as legal public holidays in title 5, or any officer or employee of the Divi- United States Code, section 6103(a). sion to whom authority has heretofore Livestock. Bovine, ovine, porcine. been delegated, or to whom authority Meat. The edible part of the muscle of may hereafter be delegated, to act in an animal, which is skeletal, or which his stead. is found in the tongue, in the dia- Division. The Meat Quality Division phragm, in the heart, or in the esoph- of the Agricultural Marketing Service. agus, and which is intended for human Fabricating. Cutting into wholesale or food, with or without the accom- retail cuts, dicing or grinding. panying and overlying fat and the por- Federal Meat Inspection. The meat in- tions of bone, skin, sinew, nerve, and spection system conducted under the blood vessels which normally accom- Federal Meat Inspection Act as amend- pany the muscle tissue and which are ed by the Wholesome Meat Act (21 not separated from it in the process of U.S.C. 601 et seq.) and the regulations dressing. This term does not include thereunder (9 CFR chapter III, sub- the muscle found in the lips, snout, or chapter A). ears. Financially interested person. Any per- Meat by-products. All edible parts son having a financial interest in the (other than meat and prepared meats) products involved, including but not intended for human food, derived from limited to the shipper, receiver, pro- one or more animals, and including but
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not limited to such organs and parts as Service. Grading service or acceptance livers, kidneys, sweetbreads, brains, service. lungs, spleens, stomachs, tripe, lips, Shipping container. The receptacle or snouts, and ears. covering in which one or more imme- Meat food products. Any articles in- diate containers of products are packed tended for human food (other than for transportation. meat, prepared meats, and meat by- Specifications. Descriptions with re- products) which are derived or prepared spect to the class, grade, other quality, in whole or in substantial and definite quantity or condition of products, ap- part, from any portion of any animal, proved by the Administrator, and except such articles as available for use by the industry re- organotherapeutic substances, meat gardless of the origin of the descrip- juice, meat extract, and the like, which tions. are only for medicinal purposes and are advertised only to the medical profes- Standards. The standards of the De- sion. partment contained in Official United Office of grading. The office of an offi- States Standards for Grades of: Carcass cial grader. Beef; Veal and Calf Carcasses; Lamb, Official grader. An employee of the Yearling Mutton, and Mutton Car- Department or other person authorized casses; and, Pork Carcasses. by the Department to determine and Supervisor of grading. An official grad- certify or otherwise identify the class, er or other person designated by the grade, other quality, or compliance of Director or Chief to supervise and products under the regulations. maintain uniformity and accuracy of Person. Any individual, partnership, service under the regulations. corporation, or other legal entity, or The Act. The Agricultural Marketing Government agency. Act of 1946 (Title II of the act of Con- Prepared meats. The products in- gress approved August 14, 1946, 60 Stat. tended for human food which are ob- 1087, as amended by Pub. L. 272, 84th tained by subjecting meat to drying, Cong., 69 Stat. 553, 7 U.S.C. 1621–1627). curing, smoking, cooking, grinding, The regulations. The regulations in seasoning, or flavoring, or to any com- this subpart. bination of such procedures, and to Yield grade. A designation which re- which no considerable quantity of any flects the estimated yield of retail cuts substance other than meat or meat by- that may be obtained from a beef, products has been added. lamb, yearling mutton, or mutton car- Processing. Drying, curing, smoking, cooking, seasoning, or flavoring or any cass. combination of such processes, with or [42 FR 53921, Oct. 4, 1977, as amended at 45 FR without fabricating. 51762, Aug. 5, 1980. Redesignated at 46 FR Products. Meats, prepared meats, 63203, Dec. 31, 1981, as amended at 61 FR meat by-products, or meat food prod- 11505, Mar. 21, 1996; 63 FR 72102, Dec. 31, 1998] ucts. Quality. A combination of the inher- § 54.2 Designation of official certifi- ent properties of a product which de- cates, memoranda, marks, other termines its relative degree of excel- identifications, and devices for pur- poses of the Agricultural Marketing lence. Act. Quality grade. A designation based on those characteristics of meat which Subsection 203(h) of the Agricultural predict the palatability characteristics Marketing Act of 1946, as amended by of the lean. Pub. L. 272, 84th Congress, provides Quality Systems Certification Program. criminal penalties for various specified A multifaceted program allowing all offenses relating to official certifi- aspects of the livestock industry to cates, memoranda, marks or other have quality systems, or processes identifications, and devices for making within quality systems, verified by such marks or identifications, issued or AMS agent(s) to effectuate use of such authorized under section 203 of said quality systems to meet contractual act, and certain misrepresentations requirements, or as a marketing tool. concerning the inspection or grading of
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agricultural products under said sec- SERVICE tion. For the purposes of said sub- section and the provisions in this part, § 54.4 Kind of service. the terms listed below shall have the (1) Grading service under the regula- respective meanings specified: tions shall consist of the determination (a) Official certificate means any form and certification and other identifica- of certification, either written or print- tion, upon request by the applicant, of ed, used under the regulations to cer- the class, grade, or other quality of tify with respect to the inspection, products under applicable standards. class, grade, quality, size, quantity, or Class, grade, and other quality may be condition of products (including the determined under said standards for meat of cattle, sheep, or swine in car- compliance of products with applicable cass form only, except upon approval specifications). by the Director upon his determination (b) Official memorandum means any of good cause and provided that the initial record of findings made by an meat can be identified in conformance authorized person in the process of with the standards. grading, determining compliance, in- (2) Certification service under the specting, or sampling pursuant to the regulations shall consist of the deter- regulations, any processing or plant- mination of the conformity of products operation report made by an author- to specifications approved by the Di- ized person in connection with grading, rector or Chief and the certification determining compliance, inspecting, or and other identification of such live- sampling under the regulations, and stock or products in accordance with any report made by an authorized per- specifications, upon request by the ap- son of services performed pursuant to plicant. Determination as to product the regulations. compliance with specifications for in- (c) Official mark or other official identi- gredient content or method of prepara- fication means any form of mark or tion may be based upon information re- other identification, including those ceived from the inspection system hav- prescribed in § 54.17; used under the reg- ing jurisdiction over the products in- ulations in marking any products, or volved. (3) The Carcass Data Service, under the immediate or shipping containers the regulations, shall consist of the thereof, to show inspection class, grade evaluation of carcass characteristics, quality, size quantity, or condition of in accordance with applicable official the products (including the compliance United States Standards of carcasses of of products with applicable specifica- animals identified with the official tions), or to maintain the identity of eartag as shown in § 54.17, the recording products for which service is provided of such data, and transmittal of the under the regulations. data to, or as directed by, the applicant (d) Official device means any roller, for the service. stamp, brand or other device used (4) The Contract Verification Serv- under the regulations to mark any ice, under the regulations, provides products or the immediate or shipping wholesale buyers of noncertified com- containers, thereof, with any official modity products a method of deter- mark or other official identification. mining whether procurement(s) met contractually specified requirements. ADMINISTRATION (5) The Quality Systems Certification Program, under the regulations, pro- § 54.3 Authority. vides meatpackers, processors, pro- The Chief is charged with the admin- ducers, or other businesses in the live- istration, under the general super- stock and meat trade the ability to vision and direction of the Director, of have special processes or documented the regulations and the Act insofar as quality management systems verified. they relate to products. [63 FR 72102, Dec. 31, 1998]
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§ 54.5 Availability of service. the Director. In any case in which the Service under these regulations may service is intended to be furnished at be made available with respect to prod- an establishment not operated by the ucts shipped or received in interstate applicant, the application shall be ap- commerce, and with respect to the proved by the operator of such estab- products not so shipped or received if lishment and such approval shall con- the Director or Chief determines that stitute an authorization for any em- the furnishing of service for such prod- ployees of the Department to enter the ucts would facilitate the marketing, establishment for the purpose of per- distribution, processing, or utilization forming their functions under the regu- of agricultural products through com- lations. The application shall state: mercial channels. Also, such service (1) The name and address of the es- may be made available under a cooper- tablishment at which service is desired; ative agreement. Service under these (2) the name and post office address of regulations shall be provided without the applicant; (3) the financial interest discrimination as to race, color, sex, of the applicant in the products, except creed, or national origin. Service will where application is made by an offi- be furnished for products only if they cial of a Government agency in his offi- were derived from animals slaughtered cial capacity; and (4) the signature of in federally inspected establishments the applicant (or the signature and or operated under State meat inspec- title of his representative). The appli- tion in a State other than one des- cation shall indicate the legal status of ignated in 9 CFR 331.2. Service under the applicant as an individual, partner- these regulations will be furnished for ship, corporation, or other form of imported meat only if it is marked so legal entity. Any change in such sta- that the name of the country of origin tus, at any time while service is being appears on most of the major retail received, shall be promptly reported to cuts. The mark of foreign origin shall the Director or Chief by the person re- be imprinted by roller brand or hand- ceiving the service. stamp and shall be applied so that the (b) Notice of eligibility for service. The imprint is at least 2 inches from the applicant for service at any establish- backbone of lamb, 3 inches from the ment will be notified whether his appli- backbone of veal and calf, and 4 inches cation is approved. from the backbone of beef carcasses. (c) Request by applicant for service—(1) The mark of foreign origin shall be re- Noncommitment. Upon notification of peated parallel to the backbone of the the approval on an application for serv- carcass so as to appear on each round, ice, the applicant may, from time to rump, full loin, rib, and chuck of each time as desired, make oral or written bovine and ovine carcass in letters at requests for service under the regula- least one-fourth of an inch high, with tions with respect to specific products no more than three-fourths of an inch for which the service is to be furnished space between impressions. Imprints of under such application. Such requests each such brand shall be submitted to shall be made at an office for grading the Chief for the determination of com- either directly or through any em- pliance with these regulations prior to ployee of the Agricultural Marketing use of the brand on meats offered for Service who may be designated for Federal grading. It shall be the respon- such purposes. sibility of the applicant to notify the (2) Commitment. If desired, the appli- meat grade performing the service cant may request to enter into an whenever imported meat is offered for agreement with the Agricultural Mar- grading. keting Service for the furnishing of service on a weekly commitment basis, § 54.6 How to obtain service. whereby the applicant agrees to pay for (a) Application. Any person may apply 8 hours of service per day, 5 days per to the Director or Chief for service week, Monday through Friday, exclud- under the regulations with respect to ing Federal legal holidays occurring products in which the applicant is fi- Monday through Friday on which no nancially interested. The application grading and certification services are shall be made on a form approved by performed, as provided in § 54.27(b), and
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the Agricultural Marketing Service Records showing the date and time of agrees to make an official grader avail- the request shall be made and kept in able to perform such service for the ap- such office. However, in the case of the plicant. However, the Agricultural Carcass Data Service, the purchase of Marketing Service reserves the right to official USDA eartags shall constitute use any grader assigned to a plant a request for such service and the req- under such a commitment to perform uisition form used to purchase the service for other applicants when, in eartags shall be kept in the designated the opinion of the Chief, the grader is office of record. not needed to perform service for the commitment applicant. An applicant § 54.9 Withdrawal of application or re- who terminates a commitment, and quest for service. within 1 year after cancellation is granted a new commitment at his re- An application or a request for serv- quest, shall pay for the moving costs ice under the regulations may be with- actually incurred by the Agricultural drawn by the applicant at any time be- Marketing Service to cover the trans- fore the application is approved or fer of the grader who will service the prior to performance of service, upon applicant’s new commitment. If more payment, in accordance with §§ 54.27 than one applicant is involved in the and 54.28, of any expenses already in- reapplication for a canceled meat grad- curred by the Agricultural Marketing ing and certification commitment re- Service in connection therewith. quiring the transfer of the grader, the moving costs will be prorated among § 54.10 Authority of agent. the applicants according to each appli- Proof of the authority of any person cant’s committed portion of the grad- making an application or a request for er’s services. However, the moving service under the regulations on behalf costs will be charged only to those ap- of any other person may be required at plicants who were parties to the pre- the discretion of the Director or Chief viously canceled commitment. An ap- or the official in charge of the office of plicant may, for periods of 3 months or grading or other employee receiving less, enter into an agreement by memo- the application or request under § 54.6. randum with the Agricultural Mar- keting Service for the furnishing of § 54.11 Denial or withdrawal of serv- service on a weekly basis. In the latter ice. case, transfer of graders would not be (a) For misconduct—(1) Bases for denial involved and charges will be made in An application or a re- accordance with § 54.27. or withdrawal. quest for service may be rejected, or [42 FR 53921, Oct. 4, 1977. Redesignated at 46 the benefits of the service may be oth- FR 63203, Dec. 31, 1981, as amended at 47 FR erwise denied to, or withdrawn from, 44704, Oct. 12, 1982] any person who, or whose employee or § 54.7 Order of furnishing service. agent in the scope of his employment or agency: Service under the regulations shall (i) Has wilfully made any misrepre- be furnished to applicants in the order sentation or has committed any other in which requests therefor are received, fraudulent or deceptive practice in con- insofar as consistent with good man- agement, efficiency and economy. nection with any application or request Precedence will be given, when nec- for service under the regulations; essary, to requests made by any gov- (ii) Has given or attempted to give, ernment agency or any regular user of as a loan or for any other purpose, any the service, and to requests for appeal money, favor, or other thing of value, service under § 54.20. to any employee of the Department au- thorized to perform any function under § 54.8 When request for service the regulations; deemed made. (iii) Has interfered with or ob- A request for service under the regu- structed, or attempted to interfere lations shall be deemed to be made with or to obstruct, any employee of when received by an office of grading. the Department in the performance of
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his duties under the regulations by in- (x) Has in any manner not specified timidation, threats, assaults, abuse, or in this paragraph violated subsection any other improper means; 203(h) of the AMA: Provided, That para- (iv) Has knowingly falsely made, graph (a)(1)(vi) of this section shall not issued, altered, forged, or counterfeited be deemed to be violated if the person any official certificate, memorandum, in possession of any item mentioned mark, or other identification, or device therein notifies the Director or Chief for making any such mark or identi- without such delay that he has posses- fication; sion of such item and, in the case of an (v) Has knowingly uttered, published, official device, surrenders it to the or used as true any such falsely made, Chief, and, in the case of any other issued, altered, forged, or counterfeited item, surrenders it to the Director or certificate, memorandum, mark, iden- Chief or destroys it or brings it into tification, or device; compliance with the regulations by ob- (vi) Has knowingly obtained or re- literating or removing the violative tained possession of any such falsely features under supervision of the Direc- made, issued, altered, forged, or coun- tor or Chief: And provided further, That terfeited certificate, memorandum, paragraphs (a)(1) (ii) through (ix) of mark, identification, or device, or of this section shall not be deemed to be any such official device, or of any prod- violated by any act committed by any uct bearing any such falsely made, person prior to the making of an appli- issued, altered, forged, or counterfeited cation of service under the regulations mark or identification, or of any car- by the principal person. An application cass or wholesale or retail cut bearing or a request for service may be rejected any designation specified in paragraph or the benefits of the service may be (a)(1)(vii) of this section which has not otherwise denied to, or withdrawn been federally graded or derived from a from, any person who operates an es- carcass graded as being of the indicated tablishment for which he has made ap- grade; plication for service if, with the knowl- (vii) Has applied the designation edge of such operator, any other person ‘‘Prime,’’ ‘‘Choice,’’ ‘‘Select,’’ ‘‘Good,’’ conducting any operations in such es- ‘‘Standard,’’ ‘‘Commercial,’’ ‘‘Utility,’’ tablishment has committed any of the ‘‘Cutter,’’ ‘‘Canner,’’ ‘‘Cull,’’ ‘‘Me- offenses specified in paragraphs (a)(1) dium,’’ ‘‘No. 1,’’ ‘‘No. 2,’’ ‘‘No. 3,’’ ‘‘No. (i) through (x) of this section after such 4,’’ ‘‘Yield Grade 1,’’ ‘‘Yield Grade 2,’’ application was made. Moreover, an ap- ‘‘Yield Grade 3,’’ ‘‘Yield Grade 4,’’ or plication or a request for service made ‘‘Yield Grade 5’’ by stamp, or brand di- in the name of a person otherwise eligi- rectly on any carcass, wholesale cut, or ble for service under the regulations retail cut of any carcass, as part of a may be rejected, or the benefits of the grade designation; service may be otherwise denied to, or (viii) Has applied to immediate con- withdrawn from, such a person (A) in tainers or shipping containers of car- case the service is or would be per- casses, wholesale cuts, or retail cuts, formed at an establishment operated grade designations specified in para- (1) by a corporation, partnership, or graph (a)(1)(vii) of this section, when other person from whom the benefits of such carcasses, wholesale cuts, or re- the service are currently being with- tail cuts contained therein have not held under this paragraph, or (2) by a been federally graded; corporation, partnership, or other per- (ix) Has knowingly used, moved, or son having an officer, director, partner, otherwise altered, in any manner, meat or substantial investor from whom the or meat products identified by an offi- benefits of the service are currently cial product control device, mark, or being withheld and who has any au- other identification as specified in thority with respect to the establish- § 54.17, or has removed such official de- ment where service is or would be per- vice, mark, or identification from the formed; or (B) in case the service is or meat or meat products so identified would be performed with respect to any without the express permission of an product in which any corporation, authorized representative of the USDA; partnership, or other person within or paragraph (a)(1)(x)(A)(1) of this section
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has a contract or other financial inter- § 54.12 Financial interest of official est. grader. (2) Procedure. All cases arising under No official grader shall grade or de- this paragraph shall be conducted in termine compliance of any products in accordance with the Rules of Practice which he or any of his relatives by Governing Formal Adjudicatory Pro- blood or marriage is directly or indi- ceedings Instituted by the Secretary rectly financially interested. Under Various Statutes set forth in §§ 1.130 through 1.151 of this title and § 54.13 Accessibility and refrigeration the Supplemental Rules of Practice in of products; access to establish- part 50 of this chapter. ments. (b) For miscellaneous reasons. An ap- (a) The applicant shall cause prod- plication or a request for service may ucts, with respect to which service is be rejected, or the benefits of the serv- requested, to be made easily accessible ice may be otherwise denied to, or for examination and to be so placed, withdrawn from, any person, without a with adequate illuminating facilities, hearing by the official in charge of the as to disclose their class, grade, other appropriate office of grading, with the quality, and compliance. Supervisors of concurrence of the Director or Chief (1) grading and other employees of the De- for administrative reasons such as the partment responsible for maintaining nonavailability of personnel to perform uniformity and accuracy of service the service; (2) for the failure to pay for under the regulations shall have access service; (3) in case the application or to all parts of establishments covered request relates to products which are by approved applications for service not eligible for service under § 54.5 or under the regulations, for the purpose which are unclean or are in an unclean of examining all products in the estab- establishment; (4) for other noncompli- lishments which have been or are to be ance with the conditions on which graded or examined for compliance service is available as provided in the with specifications or which bear any regulations, except matters covered by marks of grade or compliance. paragraph (a) of this section; or (5) in (b) Grading service will only be fur- case the person is a partnership, cor- nished for meat that a USDA grader poration, or other person from whom determines is chilled so that grade fac- the benefits of the service are cur- tors are developed to the extent that a rently being withheld under paragraph proper grade determination can be (a) of this section. Notice of such de- made in accordance with the official nial or withdrawal, and the reasons standards. To be eligible for grading, therefor, shall promptly be given to the beef carcasses must be ribbed at least person involved. 10 minutes prior to being offered for (c) Filing of records. The final orders grading. Meat that is presented in a in formal proceedings under paragraph frozen condition shall not be eligible (a) of this section to deny or withdraw for a grade determination. Meat of all the service under the regulations (ex- eligible species shall be graded only in cept orders required for good cause to the establishment where the animal be held confidential and not cited as was slaughtered or initially chilled (ex- precedents) and other records in such cept for veal and calf carcasses, which proceedings (except those required for shall be graded only after the hide is good cause to be held confidential) removed and only in the establishment shall be filed with the Hearing Clerk where such removal occurs). The Direc- and shall be available for inspection by tor may grant prior approval for grad- persons having a proper interest there- ing at a location other than the estab- in. lishment of slaughter or initial chill [42 FR 53921, Oct. 4, 1977. Redesignated at 46 upon notification to the Division if the FR 63203, Dec. 31, 1981, as amended at 50 FR Branch was unable to provide grading 14366, Apr. 12, 1985; 52 FR 35683, Sept. 23, 1987; service in a timely manner and that 60 FR 8464, Feb. 14, 1995]
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the meat can be identified in conform- determined final specification compli- ance with the standards. ance. Where weight or count is verified, [42 FR 53921, Oct. 4, 1977, as amended at 45 FR the grader shall initial in the block ti- 51762, Aug. 5, 1980. Redesignated at 46 FR tled ‘‘Weights and Total Count 63203, Dec. 31, 1981, as amended at 63 FR Verified.’’ 72102, Dec. 31, 1998] (b) Applicant Charges Certificate Form LS–5–5 (Figure 2) will be used to § 54.14 Official certificates. reduce paperwork for applicants as- (a) Agricultural Products Certificate signed multiple graders. Assigned grad- Form LS–5–3 (Figure 1) is the official ers will complete one Form LS–5–5. certificate for products under the regu- Each grader will enter their code let- lations. The official grader shall pre- ters and signature in the appropriate pare, sign, and issue an Agricultural location(s) to indicate certificate com- Products Certificate Form LS–5–3 cov- pletion. ering products for which that grader
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(c) Distribution. The original certifi- him. The remaining copies shall be for- cate, and not to exceed two copies, warded as required by agency, division, shall be delivered or mailed to the ap- and branch instructions. Additional plicant or other person designated by copies will be furnished to any person
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financially interested in the products involved with the concurrence of the applicant and upon payment of fees, as provided in § 54.27. [42 FR 53921, Oct. 4, 1977. Redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 51 FR 590, Jan. 7, 1986; 61 FR 11506, Mar. 21, 1996] (b) A shield enclosing the letters § 54.15 Advance information con- ‘‘USDA’’ as shown in Figure 1 with the cerning service rendered. appropriate quality grade designation Upon request of any applicant, all or ‘‘Prime,’’ ‘‘Choice,’’ ‘‘Select,’’ ‘‘Good,’’ any part of the contents of any certifi- ‘‘Standard,’’ ‘‘Commercial,’’ ‘‘Utility,’’ cate issued to him under the regula- ‘‘Cutter,’’ ‘‘Canner,’’ or ‘‘Cull,’’ as pro- tions, or other notification concerning vided in the official United States the determination of class, grade, other Standards for Grades of Beef, Veal and quality, or compliance of products for Calf, Lamb, Yearling Mutton, and Mut- ton Carcasses and accompanied by the such applicant may be transmitted by class designation ‘‘Bullock,’’ ‘‘Veal,’’ telegraph or telephone to him, or to ‘‘Calf,’’ ‘‘Lamb,’’ ‘‘Yearling Mutton,’’ any person designated by him, at his or ‘‘Mutton,’’ constitutes a form of of- expense. ficial identification under the regula- tions to show the quality grade, and § 54.16 Marking of products. where necessary the class, undersaid All products for which class and standards, of steer, heifer, and cow grade under the standards are deter- beef, veal, calf, lamb, yearling mutton mined under the regulations, or the im- and mutton. The code identification mediate and shipping containers there- letters of the grader performing the of, shall be stamped, branded, or other- service will appear intermittently out- wise marked with an appropriate offi- side the shield. cial identification: Provided, That ex- cept as otherwise directed by the Chief, such marking will not be required when an applicant only desires official certificates. The marking of products, or their containers, as required by this section shall be done by official graders or under their immediate supervision. [42 FR 53921, Oct. 4, 1977. Redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 63 FR (c) A shield enclosing the letters 72102, Dec. 31, 1998] ‘‘USDA’’ and the words ‘‘Yield Grade,’’ § 54.17 Official identifications. as in Figure 1, with the appropriate yield grade designation ‘‘1,’’ ‘‘2,’’ ‘‘3’’, (a) A shield enclosing the letters ‘‘4,’’ or ‘‘5’’ as provided in the Official ‘‘USDA’’ and code identification letters United States Standards for Grades of of the grader performing the service, as Fresh Beef Carcasses and the Official shown below, constitutes a form of offi- United States Standards for Grades of cial identification under the regula- Lamb, Yearling Mutton, and Mutton tions for preliminary grade of car- Carcasses constitutes a form of official casses. identification under the regulations to
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show the yield grade under said stand- lect,’’ below both as shown in Figure 1. ards. When yield graded, bull and bul- The code identification letters for the lock carcasses will be identified with grader performing the service will ap- the class designation ‘‘Bull’’ and ‘‘Bul- pear outside underneath the shield. lock,’’ respectively. The code identi- fication letters of the grader per- forming the service will appear outside the shield.
(e) Under the regulations, for yield grade identification purposes only, a (d) Under the regulations, for carcass shield enclosing the letters ‘‘US’’ on grade identification purposes only, a one side and ‘‘DA’’ on the other, with shield enclosing the letters ‘‘USDA’’ the appropriate Yield Grade designa- with the appropriate yield grade des- tion number ‘‘1,’’ ‘‘2,’’ ‘‘3,’’ ‘‘4,’’ or ‘‘5’’ ignation number of ‘‘1,’’ ‘‘2,’’ ‘‘3,’’ ‘‘4,’’ as shown in Figure 1. The code identi- or ‘‘5’’ between the ‘‘US’’ and ‘‘DA’’, fication letters for the grader per- with the appropriate quality grade des- forming the service will appear outside ignation of ‘‘Prime’’, ‘‘Choice,’’ or ‘‘Se- underneath the shield.
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(g) The letters ‘‘USDA’’ with the ap- (f) Under the regulations, for quality propriate grade designation ‘‘1,’’ ‘‘2,’’ grade identification only, a shield en- ‘‘3,’’ ‘‘4,’’ ‘‘Utility,’’ or ‘‘Cull’’ enclosed closing the letters ‘‘US’’ on one side in a shield as shown in Figure 1, as pro- and ‘‘DA’’ on the other with the appro- vided in the Official United States priate Quality Grade designation of Standards for Grades of Pork Car- ‘‘Prime,’’ ‘‘Choice,’’ or ‘‘Select’’ as casses, constitutes a form of official shown in Figure 1. The code identifica- identification under the regulations to tion letters for the grader performing show the grade under said standards of the service will appear outside under- barrow, gilt, and sow pork carcasses. neath the shield.
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NOTE: The letters ‘‘RWX’’, and ‘‘UF’’ shown in figures 1, and 2 are examples, respectively, of the code identification letters of the offi- cial grader performing the service. (i) The following, as shown in Figure 1, constitutes official identification to show quality system certification: (h) The following constitute forms of official identification under the regula- tions to show compliance of products:
(j) A shield-shaped ear tag enclosing the letters ‘‘USDA’’, the words ‘‘Car- cass Data Service,’’ as shown below (Figure 1), and a serial number con- stitutes a form of official identification under the regulations for livestock and carcasses. Other information may ap- pear on the backside of the ear tag at the option of the purchasers.
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(k)(1) One device used by USDA grad- ers is a rectangular, serially numbered, orange tag on which a shield encloses the letters ‘‘USDA’’ and the words ‘‘Product Control’’ as shown in Figure 1, constitutes a form of official identi- fication under the regulations for meat and meat products.
(2) Official graders and supervisors of meat products which are not in compli- grading may use ‘‘Product Control’’ ance with the regulations or are held tags or other methods and devices as pending the results of an examination. approved by the Administrator for the Any such meat or meat product so identification and control of meat and identified shall not be used, moved, or
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altered in any manner; nor shall offi- class, grade, other quality and compli- cial control identification be removed, ance will be removed from the product, without the express permission of an and if the person having title to the authorized representative of the USDA. product so requests, correct marks as determined on the appeal will be ap- [42 FR 53921, Oct. 4, 1977, as amended at 45 FR 51762, Aug. 5, 1980. Redesignated at 46 FR plied to the product. Examination re- 63203, Dec. 31, 1981, as amended at 50 FR quested to determine the class, grade, 14367, Apr. 12, 1985; 52 FR 35683, Sept. 23, 1987; other quality, or compliance of a prod- 61 FR 11509, Mar. 21, 1996] uct which has been altered or has un- dergone a material change since the § 54.18 Custody of identification de- original service, or examination of vices. product requested for the purpose of (a) All identification devices used in obtaining an up-to-date certificate and marking products or the containers not involving any question as to the thereof under the regulations, includ- correctness of the original service for ing those indicating compliance with the product involved shall be consid- specifications approved by the Chief, ered equivalent to original service and shall be kept in the custody of the not appeal service. Branch, and accurate records shall be (b) Grade determinations cannot be kept by the Branch of all such devices. appealed for any lot or product con- Each office of grading shall keep a sisting of less than 10 similar units. record of the devices assigned to it. Moreover, appeal service will not be Such devices shall be distributed only furnished with respect to product that to persons authorized by the Depart- has been altered or has undergone any ment, who shall keep the devices in material change since the original their possession or control at all times service. and maintain complete records of such [42 FR 53921, Oct. 4, 1977, as amended at 45 FR devices. 51762, Aug. 5, 1980. Redesignated at 46 FR (b) Upon request, applicants shall 63203, Dec. 31, 1981] provide a metal cabinet(s) or locker(s) for the secure storage of official meat § 54.20 Request for appeal service. grading equipment and identification Except as otherwise provided in devices for each Federal meat grader § 54.19, a request for appeal service with assigned to their establishment. Such respect to any product under the regu- cabinet(s) or locker(s) shall be capable lations may be made by any person of being locked with a special Govern- who is financially interested in the ment-owned lock and shall be placed in product when he disagrees with the de- an easily accessible and reasonably se- termination as to class, grade, other cure location within the applicant’s es- quality, or compliance of the product tablishment. as shown by the markings on the prod- APPEAL SERVICE uct or its containers, or as stated in the applicable certificate. A request for § 54.19 What is appeal service; mark- appeal service shall be filed with the ing products on appeal; require- Chief, directly or through the official ments for appeal; certain deter- grader who performed the original minations not appealable. service or the official in charge of the (a) Appeal service is a redetermina- office of grading to which such grader tion of the class, grade, other quality, was assigned at the time of the service, or compliance of product when the ap- or through the nearest office of grad- plicant for the appeal service formally ing. The request shall state the reasons challenges the correctness of the origi- therefor and may be accompanied by a nal determination. Only a person who copy of any previous certificate or re- has title to, or is a party to a contract port, or any other information which for the sale of, a product may request the applicant may have received re- appeal service with respect to such garding the product at the time of the product and if the original determina- original service. Such request may be tion of class, grade, other quality or made orally (including by telephone) or compliance is found on appeal to have in writing (including by telegram). If been in error all incorrect marks of made orally, the person receiving the
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request may require that it be con- § 54.25 Superseded certificates. firmed in writing. Requests for appeal The appeal certificate shall supersede service received through an official the original certificate which, there- grader or an office of grading shall be upon, shall become null and void and transmitted promptly to the Chief for shall not thereafter be deemed to show instructions. the class, grade, other quality, or com- pliance of the products described there- § 54.21 When request for appeal serv- in. However, the fees charged for the ice may be withdrawn. original service shall not be remitted. A request for appeal service may be If the original and all copies of the su- withdrawn by the applicant at any perseded certificate are not delivered time before the appeal service has been to the official with whom the request performed, upon payment of any ex- for appeal service is filed, the official penses already incurred under the regu- graders issuing the appeal certificate lations by the Branch in connection shall forward notice of such issuance therewith. and of the cancellation of the original certificate to such persons as they may § 54.22 Denial or withdrawal of appeal deem necessary to prevent fraudulent service. use of the superseded certificate. A request for appeal service may be rejected or such service may be other- § 54.26 Application of other regula- tions to appeal service. wise denied to or withdrawn from any person, without a hearing, in accord- The regulations in §§ 54.1 through ance with the procedure set forth in 54.18 and §§ 54.27 through 54.30 shall § 54.11(b), if it shall appear that the per- apply to appeal service except insofar son or product involved is not eligible as they are manifestly inapplicable. for appeal service under § 54.19, or that CHARGES FOR SERVICE the identity of the product has been lost; or for any of the causes set forth § 54.27 Fees and other charges for in § 54.11(b). Appeal service may also be service. denied to, or withdrawn from, any per- Fees and other charges equal as near- son in any case under § 54.11(a), in ac- ly as may be to the cost of the services cordance with the procedure set forth rendered shall be assessed and col- in said section. lected from applicants in accordance § 54.23 Who shall perform appeal serv- with the following provisions unless ice. otherwise provided in the cooperative agreement under which the services are Appeal service for products shall be furnished, or as provided in § 54.6. performed by official graders des- (a) Fees for Service on Noncommitment ignated by the Chief or by the official Basis (Hourly Rates). Except as other- in charge of an office of grading when wise provided in this section, fees for so authorized by the Chief, and shall be service shall be based on the time re- conducted jointly by two official grad- quired to render the service, calculated ers, or more when practicable. No offi- to the nearest 15-minute period, includ- cial grader shall perform appeal service ing official grader’s travel and certifi- for any product for which he previously cate(s) preparation time in connection performed the service. with the performance of service. A minimum charge of one-half hour shall § 54.24 Appeal certificates. be made for service pursuant to each Immediately after appeal service has request notwithstanding that the time been performed for any products, a cer- required to perform service may be less tificate designated as an ‘‘appeal cer- than 30 minutes. The base hourly rate tificate’’ shall be prepared, signed, and for noncommitment applicants shall be issued referring specifically to the $52 per hour for 8 hours or less of work original certificate and stating the performed between the hours of 6 a.m. class, grade, other quality, or compli- and 6 p.m., Monday through Friday, ex- ance of the products as shown by the cept on legal holidays; $57 per hour for appeal service. work performed in excess of 8 hours per
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day for each assigned official grader service involved on an equitable basis, and for work performed before 6 a.m. or where the travel is made by public and after 6 p.m., Monday through Fri- transportation (including hired vehi- day, and any time Saturday or Sunday, cles), a fee equal to the actual cost except on Federal legal holidays; and thereof. However, the applicant will $90 per hour for all work performed on not be charged a new mileage rate Federal legal holidays. without notification before the service (b) Fees for Service on Commitment is rendered. Basis. Minimum fees for service per- (d) Per diem charges. When service is formed under a commitment agree- requested at a place away from the of- ment or an agreement by memorandum ficial grader’s headquarters, the fee for shall be on the basis of 8 hours per day, such service shall include a per diem Monday through Friday, excluding charge if the employee performing the Federal legal holidays occurring Mon- service is paid per diem in accordance day through Friday on which no grad- with existing travel regulations. Per ing and certification services are per- diem charges to applicants will cover formed. The base hourly rate for serv- the same period of time for which the ice performed under such agreements grader receives per diem reimburse- shall be $45 per hour for 8 consecutive ment. The per diem rate will be admin- hours or less of work performed be- istratively determined by the Chief. tween the hours of 6 a.m. and 6 p.m., However, the applicant will not be Monday through Friday, except on charged a new per diem rate without Federal legal holidays; $57 per hour for notification before the service is ren- work performed in excess of 8 hours per dered. day for each assigned official grader (e) Fees for appeal service. Fees for ap- and for work performed before 6 a.m. peal service shall be determined on the and after 6 p.m., Monday through Fri- basis of the time, of two official grad- day, and any time Saturday or Sunday, ers, required to render the service, cal- except on Federal legal holidays; and culated to the nearest fifteen-minute $90 per hour for all work performed on period, including the time required for Federal legal holidays. The Agency re- the preparation of certificates and serves the right under such a commit- travel of such graders in connection ment agreement or agreement by with the performance of the service, at memorandum to use any grader as- the applicable hourly rate prescribed in signed to the plant on a commitment paragraph (a) of this section, plus any basis to perform service for other ap- travel charges and per diem for such plicants, as provided in § 54.6(c), cred- graders ordinarily chargeable under iting the commitment applicant with paragraphs (c) and (d) of this section: the number of hours charged to the Provided, That when on appeal it is other applicant, provided the allowable found that there was error in the origi- credit hours plus hours actually nal determination equal to or exceed- worked for the applicants do not ex- ing ten percent of the total number of ceed 8 hours on any day, Monday similar units of the products involved, through Friday, excluding legal holi- no charge will be made for the appeal days. service unless a special agreement (c) Travel charges. When service is re- therefor was made with the applicant quested at a place so distant from an in advance. official grader’s headquarters, or place (f) Fees for extra copies of certificates. of prior assignment on a circuitous In addition to copies of certificates fur- routing that a total of one-half hour or nished under § 54.14, any financially in- more is required for the grader to trav- terested person may obtain not to ex- el to such place and back to the head- ceed three copies of any such certifi- quarters, or to the next place of assign- cate within one year from its date of ment on a circuitous routing, the issuance upon payment of a fee of $1.00, charge for such service shall include a and not to exceed three copies of any mileage charge administratively deter- such certificate at any time thereafter, mined by the Chief, and travel tolls, if while a copy of such certificate is on applicable, for such travel prorated file in the Department, upon payment against all the applicants furnished the of a fee of $5.00.
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(g) Other charges. When costs, other his immediate supervisor. The super- than costs specified in paragraphs (a), visor of grading will investigate the (b), (c), (d), (e), and (f) of this section, matter and, if he deems advisable, will are involved in providing the services, report it to the owner or his agent. The the applicant will be charged for these supervisor of grading shall take appro- costs. The amount of these charges will priate action to correct errors found in be determined administratively by the the determination or identification of Chief. However, the applicant will not class, grade or other quality or compli- be charged for such cost without notifi- ance of products if the products are cation before the service is rendered of still owned by the person who owned the charge for such item of expense. them when, and are still located at the [42 FR 53921, Oct. 4, 1977. Redesignated at 46 establishment where, the incorrect FR 63203, Dec. 31, 1981, as amended at 47 FR service was rendered and if such service 44704, Oct. 12, 1982; 51 FR 21135, June 11, 1986; was rendered by a grader under the ju- 54 FR 21401, May 18, 1989; 55 FR 20443, May 17, risdiction of such supervisor, and the 1990; 57 FR 11427, Apr. 3, 1992; 58 FR 48592, supervisor of grading shall take ade- Sept. 17, 1993; 58 FR 64670, Dec. 9, 1993; 59 FR quate measures to prevent the recur- 1890, Jan. 13, 1994; 59 FR 13643, Mar. 23, 1994; rence of such errors. 63 FR 32966, June 17, 1998; 65 FR 34042, May 26, 2000] § 54.31 Uniforms. § 54.28 Payment of fees and other All meat graders and their super- charges. visory personnel are required to wear Fees and other charges for service clean, white, well-maintained outer shall be paid in accordance with the frocks while performing any function following provisions unless otherwise under these regulations involving con- provided in the cooperative agreement tact with or the handling of any meat under which the service is furnished. or meat product. Upon receipt of billing for fees and [45 FR 19214, Mar. 25, 1980. Redesignated at 46 other charges for service the applicant FR 63203, Dec. 31, 1981] shall remit by check, draft, or money order, made payable to the Agricul- Subpart B [Reserved] tural Marketing Service, USDA, pay- ment for the service in accordance with directions on the billing, and such fees PART 55—VOLUNTARY INSPECTION and charges shall be paid in advance if OF EGG PRODUCTS AND GRADING required by the official grader or other authorized official. Subpart A—Inspection and Grading of Egg Products MISCELLANEOUS DEFINITIONS § 54.29 Identification. Sec. All official graders and supervisors of 55.1 Meaning of words. 55.2 Terms defined. grading shall have their Agricultural 55.5 Designation of official certificates, Marketing Service identification cards memoranda, marks, other identifica- in their possession at all times while tions, and devices for purposes of the Ag- they are performing any function ricultural Marketing Act. under the regulations and shall iden- tify themselves by such cards upon re- ADMINISTRATION quest. 55.10 Authority. 55.11 Nondiscrimination. § 54.30 Errors in service. GENERAL When an official grader, supervisor of grading, or other responsible employee 55.20 Kinds of services available. 55.22 Where service is offered. of the Branch has evidence of 55.24 Basis of service. misgrading, or of incorrect certifi- 55.25 OMB control numbers assigned pursu- cation or other incorrect determina- ant to the Paperwork Reduction Act. tion or identification as to the class, grade, other quality, or compliance of a PERFORMANCE OF SERVICES product, he shall report the matter to 55.30 Licensed graders and inspectors.
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55.40 Suspension of license; revocation. 55.510 Fees and charges for services other 55.50 Cancellation of license. than on a continuous resident basis. 55.60 Surrender of license. 55.530 Travel expenses and other charges. 55.70 Identification. 55.560 Charges for continuous inspection 55.80 Political activity. and grading service on a resident basis. 55.90 Authority and duties of inspectors per- 55.570 Fees for service performed under co- forming service on a resident inspection operative agreement. basis. 55.95 Facilities and equipment to be fur- SANITARY AND PROCESSING REQUIREMENTS nished for use of graders and inspectors 55.600 General. in performing service on a resident in- 55.650 Inspection and grading. spection basis. 55.96 Schedule of operation of official Subpart B—Official U.S. Standards for plants. Palatability Scores for Dried Whole Eggs APPLICATION FOR SERVICE 55.800 Preparation of samples for palat- 55.100 Who may obtain service. ability test. 55.120 Authority of applicant. 55.820 Palatability scores for dried whole 55.130 How application for service may be eggs. made; conditions of resident service. AUTHORITY: 7 U.S.C. 1621–1627. 55.140 Application for inspection in official plants; approval. SOURCE: 36 FR 11795, June 19, 1971, unless 55.150 When application may be rejected. otherwise noted. Redesignated at 42 FR 32514, 55.160 When application may be withdrawn. June 27, 1977 and further redesignated at 46 55.170 Order of service. FR 63203, Dec. 31, 1981. 55.180 Suspension of plant approval.
DENIAL OF SERVICE Subpart A—Inspection and 55.200 Debarment. Grading of Egg Products 55.220 Other applicable regulations. DEFINITIONS 55.240 Report of violations. 55.260 Reuse of containers bearing official identification prohibited. § 55.1 Meaning of words. Under the regulations in this part IDENTIFYING AND MARKING PRODUCTS words in the singular shall be deemed 55.300 Approval of official identification. to import the plural and vice versa, as 55.310 Form of official identification symbol the case may demand. and inspection mark. 55.320 Products that may bear the inspec- § 55.2 Terms defined. tion mark. 55.330 Unauthorized use or disposition of ap- For the purpose of the regulations in proved labels. this part, unless the context otherwise 55.340 Supervision of marking and pack- requires, the following terms shall be aging. construed, respectively: 55.350 Accessibility of product. Act means the applicable provisions 55.360 Certificates. of the Agricultural Marketing Act of 55.370 Certificate issuance. 1946 (60 Stat. 1087; 7 U.S.C. 1621 et seq.), 55.380 Disposition of certificates. 55.390 Advance information. or any other Act of Congress conferring like authority. APPEALS Administrator means the Adminis- 55.400 Who may request an appeal grading trator of the Agricultural Marketing or inspection or review of a grader’s or Service (AMS) of the Department or inspector’s decision. any other officer or employee of the 55.410 Where to file an appeal. Department to whom there has here- 55.420 How to file an appeal. tofore been delegated, or to whom 55.430 When an application for an appeal there may hereafter be delegated the grading or inspection may be refused. authority to act in his stead. 55.440 Who shall perform the appeal. 55.450 Procedures for selecting appeal sam- Applicant means any interested party ples. who requests any grading or inspection 55.460 Appeal certificates. service, or appeal grading or appeal in- spection, with respect to any product. FEES AND CHARGES Chief of the Grading Branch means the 55.500 Payment of fees and charges. Chief of the Poultry Grading Branch,
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Poultry Division, Agricultural Mar- appeal grading or inspection of any keting Service. product. Class means any subdivision of a National Supervisor means (1) the offi- product based on essential physical cer in charge of the service of AMS, characteristics that differentiate be- and (2) such other employee of AMS as tween major groups of the same kind, may be designated by him. species, or method of processing. Office of grading means the office of Condition means any condition (in- any grader or inspector. cluding, but not being limited to, the Official plant means any plant in state of preservation, cleanliness, which the facilities and methods of op- soundness, wholesomeness, or fitness eration therein have been found by the for human food) of any product which Administrator to be suitable and ade- quate for grading service or inspection affects its merchantability; or any con- in accordance with this part and in dition, including, but not being limited which such service is carried on. to, the processing, handling, or pack- Person means any individual, part- aging which affects such product. nership, association, business trust, Department means the U.S. Depart- corporation, or any organized group of ment of Agriculture. persons, whether incorporated or not. Eggs of Current Production means Product or products means eggs shell eggs which have moved through (whether liquid, frozen, or dried), egg the usual marketing channels since the products and any food product which is time they were laid and are not in ex- prepared or manufactured and contains cess of 60 days old. eggs as an ingredient. Holiday or Legal holiday shall mean Quality means the inherent prop- the legal public holidays specified by erties of any product which determine the Congress in paragraph (a) of sec- its relative degree of excellence. tion 6103, Title 5, of the United States Regional Director means any employee Code. of the Department in charge of the Inspection/grading means (1) the act of service in a designated geographical determining, according to the regula- area. tions, the class, quality, quantity, or Regulations means the provisions in condition of any product by examining this part. each unit thereof or a representative Sampling means the act of taking sample drawn by a grader; (2) the act of samples of any product for grading or issuing a certificate; or (3) the act of inspection. identifying, when requested by the ap- Secretary means the Secretary of the plicant, any product by means of offi- Department or any other officer or em- cial identification pursuant to the Act ployee of the Department to whom and this part. there has heretofore been delegated, or Inspection and grading certificate or to whom there may hereafter be dele- certificate means a statement, either gated, the authority to act in his stead. written or printed, issued by a grader Service means (1) any grading or in- or inspector pursuant to the Act and spection, in accordance with the Act this part, relative to the class, quality, and the regulations in this part, of any product, (2) supervision, in any official quantity, and condition of products. plant, of the preparation or packaging Inspector/grader means any employee of any product, or (3) any appeal grad- of the Department authorized by the ing or appeal inspection of any pre- Secretary, or any other person to viously graded or inspected product. whom a license has been issued by the Shell eggs means the shell eggs of the Secretary, to investigate and certify, domesticated chicken, turkey, duck, in accordance with the Act and this goose, and guinea. part, to shippers of products and other interested parties the class, quality, [36 FR 11795, June 19, 1971, as amended at 36 quantity, and condition of such prod- FR 19301, Oct. 2, 1971; 37 FR 17816, Sept. 1, ucts. 1972. Redesignated at 42 FR 32514, June 27, 1977, as amended at 43 FR 60137, Dec. 26, 1978. Interested party means any person fi- Redesignated at 46 FR 63203, Dec. 31, 1981, as nancially interested in a transaction amended at 47 FR 46069, Oct. 15, 1982; 47 FR involving any grading, inspection, or 54421, Dec. 3, 1982]
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§ 55.5 Designation of official certifi- or affixed to or printed on the pack- cates, memoranda, marks, other aging material of any product. identifications, and devices for pur- (e) Official device means a printed poses of the Agricultural Marketing label, or other method as approved by Act. the Administrator for the purpose of Subsection 203(h) of the Agricultural applying any official mark or other Marketing Act of 1946, as amended by identification to any product of the Pub. L. 272, 84th Congress, provides packaging material thereof. criminal penalties for various specified offenses relating to official certifi- ADMINISTRATION cates, memoranda, marks or other identifications, and devices for making § 55.10 Authority. such marks or identifications, issued or The Administrator shall perform, for authorized under section 203 of said and under the supervision of the Sec- Act, and certain misrepresentations retary, such duties as the Secretary concerning the inspection or grading of may require in the enforcement or ad- agricultural products under said sec- ministration of the provisions of the tion. For the purposes of said sub- Act and this part. The Administrator is section and the provisions in this part, authorized to waive for a limited pe- the terms listed below shall have the riod any particular provisions of the respective meanings specified: regulations in this part to permit ex- (a) Official certificate means any form perimentation so that new procedures, of certification, either written or print- equipment, and processing techniques ed, used under this part to certify with may be tested to facilitate definite im- respect to the sampling, inspection, provements and at the same time to class, grade, quality, size, quantity, or determine full compliance with the condition of products (including the spirit and intent of the regulations in compliance of products with applicable this part. The Agricultural Marketing specifications). Service and its officers and employees (b) Official memorandum means any shall not be liable in damages through initial record of findings made by an acts of commission or omission in the authorized person in the process of administration of this part. grading, inspecting, or sampling pursu- ant to this part, any processing or [42 FR 2969, Jan. 14, 1977. Redesignated at 42 plant-operation report made by an au- FR 32514, June 27, 1977, and further redesig- nated at 46 FR 63203, Dec. 31, 1981] thorized person in connection with grading, inspecting, or sampling under § 55.11 Nondiscrimination. this part and any report made by an authorized person of services per- The conduct of all services and the li- formed pursuant to this part. censing of graders and inspectors under (c) Official mark means the grade these regulations shall be accom- mark, inspection mark, and any other plished without discrimination as to mark or symbol formulated pursuant race, color, religion, sex, national ori- to the regulations in this part, stating gin, age or disability. that the product was graded or in- [40 FR 20055, May 8, 1975. Redesignated at 42 spected, or for the purpose of maintain- FR 32514, June 27, 1977, and further redesig- ing the identity of the product. nated at 46 FR 63203, Dec. 31, 1981; 60 FR (d) Official identification means any 49168, Sept. 21, 1995] United States (U.S.) standard designa- tion of class, grade, quality, size, quan- GENERAL tity, or condition specified in this part § 55.20 Kinds of services available. or any symbol, stamp, label, or seal in- dicating that the product has been offi- The regulations in this part provide cially graded or inspected and/or indi- for the following kinds of services: cating the class, grade, quality, size, (a) Inspection of the processing of quantity, or condition of the product products containing eggs in official approved by the Administrator and au- plants. thorized to be affixed to any product, (b) Sampling of products.
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(c) Quantity and condition inspection Current OMB of products. 7 CFR section where identified and described control num- ber [36 FR 11795, June 19, 1971. Redesignated at 42 § 55.96 ...... 0581–0146 FR 32514, June 27, 1977 and further redesig- § 55.120 ...... 0581–0146 nated at 46 FR 63203, Dec. 31, 1981, as amend- § 55.130(a) ...... 0581–0146 ed at 58 FR 42413, Aug. 9, 1993] § 55.130(b) ...... 0581–0146 § 55.130(c) ...... 0581–0146 § 55.22 Where service is offered. § 55.140 ...... 0581–0146 § 55.150 ...... 0581–0146 Any product may be graded or in- § 55.160 ...... 0581–0146 spected wherever a grader or inspector § 55.200(a) ...... 0581–0146 § 55.240 ...... 0581–0146 is available and the facilities and the § 55.300 ...... 0581–0146 conditions are satisfactory for the con- § 55.340(c) ...... 0581–0146 duct of the service. § 55.370(a) ...... 0581–0146 § 55.380 ...... 0581–0146 § 55.24 Basis of service. § 55.390 ...... 0581–0146 § 55.400 ...... 0581–0146 (a) Products shall be graded or in- § 55.420 ...... 0581–0146 spected in accordance with such stand- § 55.560(a)(1) ...... 0581–0146 § 55.560(b)(1) ...... 0581–0146 ards, methods, and instructions as may § 55.560(b)(3)(ii) ...... 0581–0146 be issued or approved by the Adminis- § 55.600 ...... 0581–0146 trator. All service shall be subject to supervision at all times by the applica- [49 FR 2880, Jan. 24, 1984, as amended at 55 ble State supervisor, egg products su- FR 23421, June 8, 1990] pervisor, Regional Director, and Na- tional Supervisor. Whenever the super- PERFORMANCE OF SERVICES visor of a grader or inspector has evi- dence that such grader or inspector in- § 55.30 Licensed graders and inspec- correctly graded or inspected a prod- tors. uct, such supervisor shall take such ac- (a) Any person who is a Federal or tion as is necessary to correct the State employee, the employee of a grading or inspection and to cause any local jurisdiction, or the employee of a improper official identification which cooperating agency possessing proper appears on the product or containers qualifications as determined by an ex- thereof to be corrected prior to ship- amination for competency and who is ment of the product from the place of to perform grading service under this the initial grading or inspection. part, may be licensed by the Secretary (b) Whenever service is performed on as a grader or inspector. a sample basis, such sample shall be (b) All licenses issued by the Sec- drawn in accordance with the instruc- retary are to be countersigned by the tions as issued by the Administrator. officer-in-charge of the service of the Agricultural Marketing Service or by § 55.25 OMB control numbers assigned any other official of AMS designated pursuant to the Paperwork Reduc- by such officer. tion Act. (c) No person may be licensed to (a) Purpose. This section collects and grade or inspect any product in which displays the control numbers assigned he is financially interested. to information collection requirements [36 FR 11795, June 19, 1971, as amended at 37 by the Office of Management and Budg- FR 12918, June 30, 1972. Redesignated at 42 et contained in 7 CFR part 55 pursuant FR 32514, June 27, 1977, and further redesig- to the Paperwork Reduction Act of nated at 46 FR 63203, Dec. 31, 1981] 1980, Pub. L. 96–511. (b) Display. § 55.40 Suspension of license; revoca- tion. Current OMB 7 CFR section where identified and described control num- Pending final action by the Sec- ber retary, any person authorized to coun- § 55.10 ...... 0581–0146 tersign a license to perform service § 55.24(a) ...... 0581–0146 may, whenever he deems such action § 55.30(a) ...... 0581–0146 necessary to assure that any grading or § 55.40 ...... 0581–0146 § 55.90(b) ...... 0581–0146 inspection services are properly per- § 55.95(b) ...... 0581–0146 formed, suspend any license to perform
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grading or inspection service issued sence with or without pay. Willful vio- pursuant to this part, by giving notice lation of this section will constitute of such suspension to the respective li- grounds for dismissal in the case of ap- censee, accompanied by a statement of pointees and revocation of licenses in the reasons therefor. Within 7 days the case of licensees. after the receipt of the aforesaid notice and statement of reasons, the licensee [36 FR 11795, June 19, 1971, as amended at 42 may file an appeal in writing, with the FR 2969, Jan. 14, 1977. Redesignated at 42 FR Secretary, supported by any argument 32514, June 27, 1977, and further redesignated at 46 FR 63203, Dec. 31, 1981] or evidence that he may wish to offer as to why his license should not be fur- § 55.90 Authority and duties of inspec- ther suspended or revoked. After the tors performing service on a resi- expiration of the aforesaid 7-day period dent inspection basis. and consideration of such argument and evidence, the Secretary will take (a) Each inspector is authorized: such action as he deems appropriate (1) To make such observations and with respect to such suspension or rev- inspections as he deems necessary to ocation. When no appeal is filed within enable him to certify that products the prescribed 7 days, the license to have been prepared, processed, stored, perform grading or inspection service and otherwise handled in conformity is revoked. with the regulations in this part; (2) To supervise the marking of pack- § 55.50 Cancellation of license. ages containing products which are eli- Upon termination of his services as a gible to be identified with official iden- grader or inspector, each licensee shall tification; surrender his license immediately for (3) To retain in his custody, or under cancellation. his supervision, labels with official identification, marking devices, sam- § 55.60 Surrender of license. ples, certificates, seals, and reports of Each license which is canceled, sus- inspectors; pended, or revoked shall immediately (4) To deface or remove, or cause to be surrendered by the licensee to the be defaced or removed under his per- office of the service in the region in sonal supervision, any official identi- which he is located. fication from any package containing products whenever he determines that § 55.70 Identification. such products were not processed in ac- All graders, inspectors, and super- cordance with the regulations in this visors shall have in their possession at part or are not fit for human food; all times while on duty and present (5) To issue a certificate upon request upon request the means of identifica- on any product processed in the official tion furnished by the Department to plant; and such person. (6) To use retention tags or other de- § 55.80 Political activity. vices and methods as may be approved All graders and inspectors are forbid- by the Administrator for the identi- den during the period of their respec- fication and control of products which tive appointments or licenses, to take are not in compliance with the regula- an active part in political management tions in this part or are held for fur- or in political campaigns. Political ac- ther examination, and any equipment, tivity in city, county, State, or na- utensils, rooms or compartments which tional elections, whether primary or are found to be unclean or otherwise in regular, or in behalf of any party or violation of any of the regulations in candidate is prohibited, except as au- this part. No product, equipment, uten- thorized by law or regulation of the De- sil, room or compartment shall be re- partment. This applies to all ap- leased for use until it has been made pointees, including, but not being lim- acceptable. Such identification shall ited to, temporary and cooperative em- not be removed by anyone other than ployees and employees on leave of ab- inspector or grader.
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(b) Each inspector shall prepare such proved if a grader is available. Clock reports and records as may be pre- hours of daily operations need not be scribed by the officer-in-charge of the specified in the request, although as a service. condition of continued approval, the [36 FR 11795, June 19, 1971, as amended at 42 hours of operation shall be reasonably FR 2969, Jan. 14, 1977. Redesignated at 42 FR uniform from day to day. As an alter- 32514, June 27, 1977, and further redesignated native, the normal operating schedule at 46 FR 63203, Dec. 31, 1981] shall consist of a continuous 10-hour period per day (excluding not to exceed § 55.95 Facilities and equipment to be 1 hour for lunch), 4 consecutive days furnished for use of graders and in- per week, within the administrative spectors in performing service on a workweek, Sunday through Saturday resident inspection basis. for each full shift required. Graders are (a) Facilities and equipment for prop- to be given reasonable advance notice er sampling, weighing, examination of by management of any change in the products and monitoring processing hours that grading service is requested. procedures shall be furnished by the of- ficial plant for use by inspectors and [48 FR 20682, May 9, 1983, as amended at 60 graders. Such facilities and equipment FR 49168, Sept. 21, 1995] shall include but not be limited to a APPLICATION FOR SERVICE room or area suitable for sampling product, and acceptable candling light, § 55.100 Who may obtain service. flashlight, heavy duty, high speed drill (a) An application for service may be with an eleven sixteenths-inch or larg- made by any interested person, includ- er bit of sufficient length to reach the ing, but not being limited to, the bottom of containers used for frozen United States, any State, county, mu- eggs, metal stem thermometer(s), test nicipality, or common carrier, and any thermometer(s), stop watch, test authorized agent of the foregoing. weighing scale(s) and test weight(s), (b) Where service is offered: Any test kit for determining the bacteri- product may be graded or inspected, cidal strength of sanitizing solutions, wherever a grader or inspector is avail- and stationary or adequately secured able and the facilities and the condi- storage box or cage (capable of being tions are satisfactory for the conduct locked only by the inspector) for hold- of the service. ing official samples. (b) Acceptable furnished office space § 55.120 Authority of applicant. and equipment, including but not being Proof of the authority of any person limited to, a desk, lockers or cabinets applying for any service may be re- (equipped with a satisfactory locking quired at the discretion of the Admin- device) suitable for the protection and istrator. storage of supplies, and with facilities for inspectors and graders to change § 55.130 How application for service clothing. may be made; conditions of resident [60 FR 49168, Sept. 21, 1995] service. (a) On a fee basis. An application for § 55.96 Schedule of operation of offi- any service may be made in any office cial plants. of grading, or with any grader or in- Grading operating schedules for serv- spector at or nearest the place where ices performed pursuant to § 55.560 shall the service is desired. Such application be requested in writing and be ap- for service may be made orally (in per- proved by the Administrator. Normal son or by telephone), in writing or by operating schedules for a full week telegraph. If an application for grading consist of a continuous 8-hour period service is made orally, the office of per day (excluding not to exceed 1 hour grading, grader or inspector with whom for lunch), 5 consecutive days per week, such application is made, or the Ad- within the administrative workweek, ministrator may require that the appli- Sunday through Saturday, for each cation be confirmed in writing. shift required. Less than 8-hour sched- (b) On a resident inspection basis. An ules may be requested and will be ap- application for inspection on a resident
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inspection basis to be rendered in an having a substantial financial interest official plant must be made in writing or share in the applicant is currently on forms approved by the Adminis- denied the benefits of the Act or was trator and filed with the Adminis- responsible in whole or in part for the trator. Such forms may be obtained at current denial of the benefits of the the national, regional, or State grading Act to any person; (d) where the Ad- office. In making application, the ap- ministrator determines that the appli- plicant agrees to comply with the cation is an attempt on the part of a terms and conditions of the regulations person currently denied the benefits of in this part (including, but not being the Act to obtain service; (e) whenever limited to, such instructions governing the applicant, after an initial survey grading and inspection of products as has been made in accordance with may be issued from time to time by the § 55.140, fails to bring the plant, facili- Administrator). No member of or dele- ties, and operating procedures into gate to Congress or Resident Commis- compliance with the regulations in this sioner, shall be admitted to any benefit part within a reasonable period of that may arise from such service un- time; (f) notwithstanding any prior ap- less derived through service rendered a proval whenever, before inauguration corporation for its general benefit. of service, the applicant fails to fulfill (c) Form of application. Each applica- commitments concerning the inau- tion for grading or inspecting a speci- guration of the service; (g) when it ap- fied lot of any product shall include pears that to perform the services spec- such information as may be required ified in this part would not be to the by the Administrator in regard to the best interests of the public welfare or product and the premises where such of the Government; or (h) when it ap- product is to be graded or inspected. pears to the Administrator that prior commitments of the Department ne- § 55.140 Application for inspection in cessitate rejection of the application. official plants; approval. Each such applicant shall be promptly Any person desiring to process prod- notified by registered mail of the rea- ucts under inspection service must re- sons for the rejection. A written peti- ceive approval of such plant and facili- tion for reconsideration of such rejec- ties as an official plant prior to the in- tion may be filed by the applicant with stallation of such service. The initial the Administrator if postmarked or de- survey, drawings, and specifications to livered within 10 days after receipt of be submitted, changes and revisions in notice of the rejection. Such petition the official plant, and final survey and shall state specifically the errors al- procedure for plant approval shall be in leged to have been made by the Admin- accordance with and conform with the istrator in rejecting the application. applicable provisions of § 59.146 of this Within 20 days following the receipt of chapter, regulations governing the in- such a petition for reconsideration, the spection of eggs and egg products. Administrator shall approve the appli- [40 FR 20055, May 8, 1975. Redesignated at 42 cation or notify the applicant by reg- FR 32514, June 27, 1977, and further redesig- istered mail of the reasons for the re- nated at 46 FR 63203, Dec. 31, 1981] jection thereof.
§ 55.150 When application may be re- [36 FR 11795, June 19, 1971. Redesignated at 42 jected. FR 32514, June 27, 1977, and further redesig- nated at 46 FR 63203, Dec. 31, 1981, as amend- Any application for service may be ed at 47 FR 46069, Oct. 15, 1982; 47 FR 54421, rejected by the Administrator (a) Dec. 3, 1982] whenever the applicant fails to meet the requirements of the regulations in § 55.160 When application may be this part prescribing the conditions withdrawn. under which the service is made avail- An application for service may be able; (b) whenever the product is owned withdrawn by the applicant at any by or located on the premises of a per- time before the service is performed son currently denied the benefits of the upon payment, by the applicant, of all Act; (c) where any individual holding expenses incurred by AMS in connec- office or a responsible position with or tion with such application.
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§ 55.170 Order of service. withdrawal of inspection and grading Service shall be performed, insofar as services in formal adjudicatory pro- practicable, in the order in which ap- ceedings instituted by the Secretary (7 plications therefor are made except CFR, part 1, subpart H) shall be appli- that precedence may be given to any cable to such a debarment action: application for an appeal. (1) Misrepresentation, deceptive, or fraudulent act or practice. Any willful [36 FR 11795, June 19, 1971, as amended at 42 misrepresentation or any deceptive or FR 2969, Jan. 14, 1977. Redesignated at 42 FR fraudulent act or practice found to be 32514, June 27, 1977, and further redesignated made or committed by any person in at 46 FR 63203, Dec. 31, 1981] connection with: § 55.180 Suspension of plant approval. (i) The making or filing of an appli- cation for any service or appeal; (a) Any plant approval pursuant to (ii) The making of the product acces- the regulations in this part may be sus- sible for sampling, grading or inspec- pended for (1) failure to maintain plant tion; and equipment in a satisfactory state (iii) The making, issuing or using or of repairs; (2) the use of operating pro- attempting to issue or use any certifi- cedures which are not in accordance with the regulations in this part; or (3) cate, symbol, stamp, label, seal, or alterations of buildings, facilities, or identification authorized pursuant to equipment which cannot be approved in the regulations in this part; accordance with the regulations in this (iv) The use of the terms ‘‘United part. States,’’ ‘‘U.S.,’’ ‘‘Government Grad- (b) During such period of suspension, ed,’’ ‘‘Federal-State Graded,’’ ‘‘U.S. In- inspection service shall not be ren- spected,’’ ‘‘Government Inspected,’’ or dered. However, the other provisions of terms of similar import in the labeling the regulations in this part pertaining or advertising of any product; to providing service on a resident basis (v) The use of any official stamp, will remain in effect unless service is symbol, label, seal, or identification in terminated in accordance with the the labeling or advertising of any prod- terms thereof. If the plant facilities or uct. methods of operation are not brought (2) Use of facsimile forms. Using or at- into compliance within a reasonable tempting to use a form which simu- period of time to be specified by the lates in whole or in part any certifi- Administrator, the application and cate, symbol, stamp, label, seal, or service shall be terminated. Upon ter- identification authorized to be issued mination of service in an official plant or used under the regulations in this pursuant to the regulations in this part. part, the plant approval shall also be- (3) Willful violation of the regulations. come terminated and all labels, seals, Any willful violation of the regulations tags, or packaging material bearing of- in this part or the Act. ficial identification shall, under the su- (4) Interfering with a grader, inspector, pervision of a person designated by the or employee of AMS. Any interference Administrator, either be destroyed, or with or obstruction or any attempted the official identification completely interference or obstruction of or as- obliterated, or sealed in a manner ac- sault upon any grader, licensee, inspec- ceptable to the Department. tor or employee of AMS in the perform- ance of his duties. The giving or offer- DENIAL OF SERVICE ing, directly or indirectly, of any money, loan, gift, or anything of value § 55.200 Debarment. to an employee of AMS, or the making (a) The following acts or practices or or offering of any contribution to or in the causing thereof may be deemed suf- any way supplementing the salary, ficient cause for the debarment by the compensation or expenses of an em- Administrator, of any person, includ- ployee of AMS, or the offering or enter- ing any agents, officers, subsidiaries, ing into a private contract or agree- or affiliates of such person, from any or ment with an employee of AMS for any all benefits of the Act for a specified services to be rendered while employed period. The rules of practice governing by AMS.
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(5) Miscellaneous. The existence of ‘‘product(s)’’ shall be substituted and any of the conditions set forth in used for this part 55. § 55.150 constituting the basis for the rejection of an application for grading [40 FR 20055, May 8, 1975. Redesignated at 42 FR 32514, June 27, 1977, and further redesig- or inspection service. nated at 46 FR 63203, Dec. 31, 1981] [36 FR 11795, June 19, 1971. Redesignated at 42 FR 32514, June 27, 1977, as amended at 43 FR § 55.310 Form of official identification 60137, Dec. 26, 1978. Redesignated at 46 FR symbol and inspection mark. 63203, Dec. 31, 1981] (a) The shield set forth in Figure 1, § 55.220 Other applicable regulations. containing the letters ‘‘USDA,’’ shall be the official identification symbol for Compliance with the regulations in the purposes of this part and when this part shall not excuse failure to used, imitated, or simulated in any comply with any other Federal or any State or municipal applicable laws or manner in connection with a product regulations. shall be deemed to constitute a rep- resentation that the product has been § 55.240 Report of violations. officially inspected for the purpose of Each grader and inspector shall re- § 55.5. port, in the manner prescribed by the Administrator, all violations and non- compliance under the Act and this part of which such grader or inspector has knowledge.
§ 55.260 Reuse of containers bearing official identification prohibited. The reuse, by any person, of con- tainers bearing official identification is prohibited unless such identification is applicable in all respects to product being packed therein. In such in- stances, the container and label may be used provided the packaging is accom- plished under the supervision of an in- spector or grader and the container is in clean, sound condition and lined with a suitable inner liner. (b) The inspection marks which are permitted to be used on products shall IDENTIFYING AND MARKING PRODUCTS be contained within the outline of a shield and with the wording and design § 55.300 Approval of official identifica- set forth in Figure 2 of this section, ex- tion. cept the plant number may be preceded Labeling procedures, required infor- by the letter ‘‘P’’ in lieu of the word mation on labels, and method of label ‘‘plant’’. Alternatively, it may be omit- approval, shall be in accordance with ted from the official shield if applied and conform with the applicable provi- on the container’s principal display sions of § 59.411 of this chapter, regula- panel or other prominent location and tions governing the inspection of eggs preceded by the letter ‘‘P’’ or the word and egg products, except where ‘‘egg ‘‘Plant’’. product(s)’’ is used in § 59.411, the word
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or packaging material bearing official identification to be used to identify product packed by the plant shall ei- ther be destroyed, or have the official identification completely obliterated under the supervision of a USDA rep- resentative, or, if to be used at another location, modified in a manner accept- able to the Service. [36 FR 11795, June 19, 1971, as amended at 40 FR 20055, May 8, 1975; 42 FR 2969, Jan. 14, 1977. Redesignated at 42 FR 32514, June 27, 1977, and further redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 60 FR 49168, Sept. 21, 1995]
§ 55.340 Supervision of marking and packaging. (a) Evidence of label approval. No grad- [36 FR 11795, June 19, 1971, as amended at 40 er or inspector shall authorize the use FR 20055, May 8, 1975. Redesignated at 42 FR of official identification on any in- 32514, June 27, 1977, and further redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 60 spected product unless he has on file FR 49168, Sept. 21, 1995] evidence that such official identifica- tion or packaging material bearing § 55.320 Products that may bear the in- such official identification has been ap- spection mark. proved in accordance with the provi- Products which are permitted to bear sions of § 55.300. the inspection mark shall be processed (b) Affixing of official identification. No in an official plant from edible shell official identification may be affixed to eggs or other edible egg products eligi- or placed on or caused to be affixed to ble to bear the inspection mark and or placed on any product or container may contain other edible ingredients. thereof except by a grader or inspector The official mark, when used, shall be or under the supervision of a grader or printed or lithographed and applied as inspector or other person authorized by a part of the principal display panel of the Administrator. All such products the container, but shall not be applied shall have been inspected in accord- to a detachable cover. ance with the regulations in this part. The grader or inspector shall have su- § 55.330 Unauthorized use or disposi- pervision over the use and handling of tion of approved labels. all material bearing any official identi- (a) Containers or labels which bear fication. official identification approved for use (c) Labels for products sold under Gov- pursuant to § 55.300 shall be used only ernment contract. The grader or inspec- for the purpose for which approved. tor-in-charge may approve labels for Any unauthorized use or disposition of containers of product sold under a con- approved containers or labels which tract specification to governmental bear any official identification may re- agencies when such product is not of- sult in cancellation of the approval and fered for resale to the general public: denial of the use of containers or labels Provided, That the contract specifica- bearing official identification or denial tions include complete specific require- of the benefits of the Act pursuant to ments with respect to labeling, and are the provisions of § 55.200; made available to the grader or inspec- (b) The use of simulations or imita- tor. tions of any official identification by any person is prohibited; § 55.350 Accessibility of product. (c) Upon termination of inspection Each product for which service is re- service in an official plant pursuant to quested shall be so placed as to disclose the regulations in this part, all labels fully its class, quality, quantity, and
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condition as the circumstances may position schedule for inspection pro- warrant. gram records. [36 FR 11795, June 19, 1971. Redesignated at 42 § 55.360 Certificates. FR 32514, June 27, 1977 and further redesig- Certificates (including appeal certifi- nated at 46 FR 63203, Dec. 31, 1981, as amend- cates) shall be issued on forms ap- ed at 47 FR 46069, Oct. 15, 1982; 47 FR 54421, proved by the Administrator. Dec. 3, 1982] § 55.390 Advance information. § 55.370 Certificate issuance. Upon request of an applicant, all or (a) Resident service. Certificates will part of the contents of any certificate be issued only upon a request therefor issued to such applicant may be tele- by the applicant or AMS. When re- phoned or telegraphed to him, or to quested, an inspector shall issue a cer- any person designated by him, at his tificate covering product inspected by expense. him. In addition, an inspector may issue a certificate covering product in- APPEALS spected in whole or in part by another inspector when the inspector has § 55.400 Who may request an appeal grading or inspection or review of a knowledge that the product is eligible grader’s or inspector’s decision. for certification based on personal ex- An appeal grading or inspection may amination of the product or official in- be requested by any interested party spection records. who is dissatisfied with the determina- (b) Other than resident service. Each tion by a grader or inspector of the inspector shall, in person or by his au- class, quality, quantity, or condition of thorized agent, issue a certificate cov- any product, as evidenced by the USDA ering each product inspected by him. inspection mark and accompanying An inspector’s name may be signed on label, or as stated on a certificate and a certificate by a person other than the a review may be requested by the oper- inspector, if such person has been des- ator of an official plant with respect to ignated as the authorized agent of such a grader’s or inspector’s decision or on inspector by the National Supervisor: any other matter related to grading or Provided, That the certificate is pre- inspection in the official plant. pared from an official memorandum of inspection signed by the inspector: And § 55.410 Where to file an appeal. provided further, That a notarized (a) Appeal of resident grader’s or in- power of attorney authorizing such sig- spector’s grading or decision in an official nature has been issued to such person plant. Any interested party who is not by the inspector and is on file in the of- satisfied with the determination of the fice of the service. In such case, the au- class, quality, quantity, or condition of thorized agent shall sign both his own product which was graded or inspected and the inspector’s name, e.g., ‘‘John by a grader or inspector in an official Doe by Richard Roe.’’ plant and has not left such plant, and the operator of any official plant who § 55.380 Disposition of certificates. is not satisfied with a decision by a grader or inspector on any other mat- The original and a copy of each cer- ter relating to grading or inspection in tificate, issued pursuant to § 55.370 and such plant may request an appeal grad- not to exceed two additional copies ing or inspection or review of the deci- thereof if requested by the applicant sion by the grader or inspector by fil- prior to issuance, shall, immediately ing such request with the grader’s or upon issuance, be delivered or mailed inspector’s immediate supervisor. to the applicant or person designated (b) All other appeal requests. Any in- by him. Other copies shall be filed and terested party who is not satisfied with retained in accordance with the dis- the determination of the class, quality,
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quantity, or condition of product which § 55.440 Who shall perform the appeal. has left the official plant where it was (a) An appeal grading or inspection graded or inspected or which was grad- or review of a decision requested under ed or inspected other than in an official § 55.410(a) shall be made by the grader’s plant may request an appeal grading or or inspector’s immediate supervisor or inspection by filing such request with by a licensed grader or inspector as- the Regional Director in the region signed by the immediate supervisor where the product is located or with other than the grader or inspector the Chief of the Grading Branch. whose grading or inspection or decision is being appealed. [36 FR 11795, June 19, 1971. Redesignated at 42 (b) Appeal gradings or inspections re- FR 32514, June 27, 1977, and further redesig- quested under § 55.410(b) shall be per- nated at 46 FR 63203, Dec. 31, 1981, as amend- ed at 60 FR 49168, Sept. 21, 1995] formed by a grader or inspector other than the grader or inspector who origi- § 55.420 How to file an appeal. nally graded or inspected the product. (c) Whenever practical, an appeal The request for an appeal grading or grading or inspection shall be con- inspection or review of a grader’s or in- ducted jointly by two graders or in- spector’s decision may be made orally spectors. The assignment of the grad- or in writing. If made orally, written er(s) or inspector(s) who will make the confirmation may be required. The ap- appeal grading or inspection under plicant shall clearly state the identity § 55.410(b) shall be made by the Re- of the product, the decision which is gional Director or the Chief of the questioned, and the reason(s) for re- Grading Branch. questing the appeal service. If such ap- peal request is based on the results § 55.450 Procedures for selecting ap- peal samples. stated on an official certificate, the original and all copies of the certifi- (a) Prohibition on movement of prod- cate available at the appeal grading or uct. Products shall not have been moved from the place where the grad- inspection site shall be provided to the ing or inspection being appealed was appeal grader or inspector assigned to performed and must have been main- make the appeal grading or inspection. tained under adequate refrigeration, [60 FR 49168, Sept. 21, 1995] when applicable. (b) Laboratory analyses. The appeal § 55.430 When an application for an sample shall consist of product taken appeal grading or inspection may from the original sample containers be refused. plus an equal number of containers se- When it appears to the official with lected at random. When the original whom an appeal request is filed that sample containers cannot be located, the appeal sample shall consist of prod- the reasons given in the request are uct taken at random from double the frivolous or not substantial, class, number of original sample containers. quality, quantity, or that the condition (c) Condition inspection. The appeal of the product has undergone a mate- sample shall consist of product taken rial change since the original grading from the original sample containers or inspection, or that the original lot plus an equal number of containers se- has changed in some manner, or the lected at random. A condition appeal Act or the regulations in this part have cannot be made unless all originally not been complied with, the applicant’s sampled containers are available. request for the appeal grading or in- [36 FR 11795, June 19, 1971. Redesignated at 42 spection may be refused. In such case, FR 32514, June 27, 1977, and further redesig- the applicant shall be promptly noti- nated at 46 FR 63203, Dec. 31, 1981, as amend- fied of the reason(s) for refusal. ed at 60 FR 49168, Sept. 21, 1995]
[36 FR 11795, June 19, 1971. Redesignated at 42 § 55.460 Appeal certificates. FR 32514, June 27, 1977, and further redesig- nated at 46 FR 63203, Dec. 31, 1981, as amend- Immediately after an appeal grading ed at 60 FR 49168, Sept. 21, 1995] or inspection is completed, an appeal certificate shall be issued to show that
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the original grading or inspection was an appeal) performed, in accordance sustained or was not sustained. Such with this part on a fee basis shall be certificate shall supersede any pre- based on the applicable rates specified viously issued certificate for the prod- in §§ 55.510 through 55.560, both inclu- uct involved and shall clearly identify sive. the number and date of the superseded (b) Fees for product inspection and certificate. The issuance of the appeal sampling for laboratory analysis will certificate may be withheld until any be based on the time required to per- previously issued certificate and all form the services. The hourly charge copies have been returned when such shall be $33.64 and shall include the action is deemed necessary to protect time actually required to perform the the interest of the Government. When sampling and inspection, waiting time, the appeal grader or inspector assigns a travel time, and any clerical costs in- different class to the lot or determines volved in issuing a certificate. that a net weight shortage exists, the (c) Services rendered on Saturdays, lot shall be retained pending correction Sundays, or legal holidays shall be of the labeling or approval of the prod- charged for at the rate of $35.52 per uct disposition by the National Super- hour. Information on legal holidays is visor. available from the Supervisor. (d) The cost of an appeal grading, in- [36 FR 11795, June 19, 1971. Redesignated at 42 FR 32514, June 27, 1977, and further redesig- spection, laboratory analysis, or review nated at 46 FR 63203, Dec. 31, 1981, as amend- of a grader’s or inspector’s decision ed at 60 FR 49168, Sept. 21, 1995] shall be borne by the appellant at an hourly rate of $27.36 for time spent per- FEES AND CHARGES forming the appeal and travel time to and from the site of the appeal, plus § 55.500 Payment of fees and charges. any additional expenses. If the appeal (a) Fees and charges for any service grading, inspection, laboratory anal- shall be paid by the interested party ysis, or review of a grader’s or inspec- making the application for such serv- tor’s decision discloses that a material ice, in accordance with the applicable error was made in the original deter- provisions of this section and §§ 55.510 mination, no fee or expenses will be through 55.560, both inclusive. If so re- charged. quired by the grader or inspector, such [36 FR 11795, June 19, 1971. Redesignated at 42 fees and charges shall be paid in ad- FR 32514, June 27, 1977, as amended at 46 FR vance. 8, Jan. 2, 1981. Redesignated at 46 FR 63203, (b) Fees and charges for any service Dec. 31, 1981, as amended at 59 FR 52637, Oct. shall, unless otherwise required pursu- 18, 1994] ant to paragraph (c) of this section, be paid by check, draft, or money order § 55.530 Travel expenses and other payable to the Agricultural Marketing charges. Service and remitted promptly to Charges are to be made to cover the AMS. cost of travel and other expenses in- (c) Fees and charges for any service curred by the Department in connec- under a cooperative agreement with tion with rendering grading service. any State or person shall be paid in ac- Such charges shall include the costs of cordance with the terms of such coop- transportation, per diem, shipping con- erative agreement. tainers, postage, and any other ex- penses. [36 FR 11795, June 19, 1971, as amended at 42 FR 2969, Jan. 14, 1977. Redesignated at 42 FR [42 FR 2969, Jan. 14, 1977. Redesignated at 42 32514, June 27, 1977, and further redesignated FR 32514, June 27, 1977, as amended at 46 FR at 46 FR 63203, Dec. 31, 1981] 8, Jan. 2, 1981. Redesignated at 46 FR 63203, Dec. 31, 1981] § 55.510 Fees and charges for services other than on a continuous resident § 55.560 Charges for continuous in- basis. spection and grading service on a (a) Unless otherwise provided in this resident basis. part, the fees to be charged and col- Fees to be charged and collected for lected for any service (other than for service on a resident basis shall be
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those provided in this section. The fees (i) For all regular hours of work to be charged for any appeal grading or scheduled and approved as an estab- inspection shall be as provided in lished tour of duty for a plant, the reg- § 55.510. ular rate charge will be made. The reg- (a) Charges. The charges for the serv- ular rate charge will be determined by ice shall be paid by the applicant and adding an amount to the base salary shall include items listed in this sec- rate to cover the costs to AMS for such tion as are applicable. Payment for the items as the Employer’s Tax imposed full cost of the service rendered to the under the U.S. Internal Revenue Code applicant shall be made by the appli- (26 U.S.C.) for Old Age and Survivor’s cant to the Agricultural Marketing Benefits under the Social Security Sys- Service, U.S. Department of Agri- tem, retirement benefits, groups life culture. Such full costs shall comprise insurance, severance pay, sick leave, such of the items listed in this section as are due and included in the bill or annual leave, additional salary and bills covering the period or periods dur- travel costs for relief grading service, ing which the grading and inspection accident payments, certain moving service was rendered. Bills will be ren- costs, and related servicing costs. dered by the 10th day following the end (ii) All hours worked by an assigned of the billing period in which the serv- grader or inspector or another grader ice was rendered and are payable upon or inspector in excess of the approved receipt. tour of duty, or worked on a non- (1) An inauguration charge of $310 scheduled workday, or actually worked will be made at the time an application on a holiday in excess of the tour of for service is signed except when the duty, will be considered as overtime. application is required because of a The charge for such overtime will be change in name or ownership. If service 150 percent of the grader’s or inspec- is not installed within 6 months from tor’s base salary rate. the date the application is filed, or if (iii) For work performed on a holiday service is inactive due to an approved which is within the established tour of request for removal of a grader(s) or in- duty approved for a plant, the added spector(s) for a period of 6 months, the charge will be the same as the grader’s application will be considered termi- or inspector’s base rate. nated, but a new application may be (iv) For work performed between 6 filed at any time. In addition, there will be a charge of $300 if the applica- p.m. and 6 a.m., night differential tion is terminated at the request of the charges (for regular, overtime, or holi- applicant for reasons other than for a day hours worked during this period) change in location, within 12 months will be at the applicable rates estab- from the date of the inauguration of lished plus 10 percent of the base rate. service. (v) For work performed on Sunday, (2) A charge for the salary and other Sunday differential charges (for reg- costs, as specified in this subparagraph, ular, overtime, or holiday hours for each grader or inspector while as- worked on Sunday) will be at the appli- signed to a plant, except that no cable rates established plus 25 percent charge will be made when the assigned of the base rate. grader or inspector is temporarily reas- (vi) For all hours of work performed signed by AMS to perform grading or in a plant without an approved tour of inspection service for other than the duty, the charge will be one of the ap- applicant. Base salary rates will be de- plicable hourly rates in § 55.510. termined on a national average for all (3) An administrative service charge official plants operating in States equal to 25 percent of the grader’s or under a Federal Trust Fund Agreement inspector’s total salary costs. A min- where Federal graders, State graders, imum charge of $215 will be made each or a combination of Federal and State graders are used, by averaging the sal- billing period. The minimum charge ary rates paid to each Federal or State also applies where an approved applica- grader assigned to such plants. Charges tion is in effect and no product is han- to plants are as follows: dled.
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(b) Other provisions. (1) The applicant SANITARY AND PROCESSING shall designate in writing the employ- REQUIREMENTS ees of the applicant who will be re- quired and authorized to furnish each § 55.600 General. grader or inspector with such informa- Except as otherwise approved by the tion as may be necessary for the per- Administrator, the sanitary, proc- formance of the service. essing, and facility requirements, as (2) AMS will provide, as available, an applicable, shall be the same for the adequate number of graders or inspec- product processed under this part as tors to perform the service. The num- for egg products processed under §§ 59.500 through 59.580(c) of this chap- ber of graders or inspectors required ter and § 55.650. will be determined by AMS based on the expected demand for service. § 55.650 Inspection and grading. (3) The service shall be provided at Examinations of the ingredients, designated locations and shall be con- processing, and the product shall be tinued until the service is suspended, made to assure the production of a withdrawn, or terminated by: wholesome, unadulterated, and prop- (i) Mutual consent; erly labeled product. Such examina- (ii) Thirty (30) days’ written notice, tions include, but are not being limited by either the applicant or AMS speci- to: fying the date of suspension, with- (a) Sanitation checks of plant prem- drawal, or termination; ises, facilities, equipment, and proc- (iii) One (1) day’s written notice by essing operations. AMS to the applicant if the applicant (b) Checks on ingredients and addi- fails to honor any invoice within thirty tives used in products to assure that (30) days after date of invoice covering they are not adulterated, are fit for use as human food, and are stored, handled, the cost of the grading and inspection and used in a sanitary manner. service; or (c) Examination of the eggs or egg (iv) Action taken by AMS pursuant products used in the products to assure to the provisions of § 55.180 or § 55.200. they are wholesome, not adulterated, (4) Graders or inspectors will be re- and comply with the temperature, pas- quired to confine their activities to teurization, or other applicable re- those duties necessary in the rendering quirements. of service and such closely related ac- (d) Inspection during the processing tivities as may be approved by the Ad- and production of the product to deter- ministrator. mine compliance with any applicable (5) When similar services are fur- standard or specification for such prod- nished to the same applicant under uct. part 56 or part 70 of this chapter, the (e) Examination during processing of charges listed in this section shall not the product to assure compliance with approved formulas and labeling. be repeated. (f) Test weighing and organoleptic [36 FR 11795, June 19, 1971. Redesignated at 42 examinations of finished product. FR 32514, June 27, 1977, and further redesig- nated at 46 FR 63203, Dec. 31, 1981] Subpart B—Official U.S. Standards EDITORIAL NOTE: For FEDERAL REGISTER ci- for Palatability Scores for tations affecting § 55.560, see the List of CFR Dried Whole Eggs Sections Affected, which appears in the Finding Aids section of the printed volume § 55.800 Preparation of samples for and on GPO Access. palatability test. Reconstitute 33 grams of dried whole § 55.570 Fees for service performed egg powder as completely as possible under cooperative agreement. with 90 grams of distilled water in a The fees to be charged and collected suitable, clean container. Add the for any service performed under coop- water and mix until the mixture is erative agreement shall be those pro- smooth and free from lumps. Place the vided for by such agreement. container in gently boiling water and
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stir the mixture while coagulation 56.12 Suspension of license; revocation. takes place. When coagulated to the 56.13 Cancellation of license. consistency of scrambled eggs, the 56.14 Surrender of license. sample is ready for the palatability 56.15 Political activity. test. 56.16 Identification. 56.17 Facilities and equipment for graders. § 55.820 Palatability scores for dried 56.18 Schedule of operation of official whole eggs. plants. The palatability score of the pre- APPLICATION FOR GRADING pared sample shall be determined by a 56.20 Who may obtain grading service. panel of officially qualified graders of 56.21 How application for service may be dried eggs of the Agricultural Mar- made; conditions of service. keting Service, and shall be rated in 56.22 Filing of application. accordance with the following table: 56.23 Form of application. 56.24 When application may be rejected. Score Description of Quality 56.25 When application may be withdrawn. 56.26 Authority of applicant. 8 ...... No detectable off flavor, comparable to high 56.27 Order of service. quality fresh shell eggs. 1 7 ⁄2 ...... Very slight off flavor. VIOLATIONS 7 ...... Slight but not unpleasant off flavor. 61⁄2 ...... Definite but not unpleasant off flavor. 56.30 Report of violations. 6 ...... Pronounced off flavor (slightly unpleasant). 5 ...... Unpleasant off flavor. DENIAL OF SERVICE 4 ...... Definite unpleasant off flavor. 3 ...... Pronounced unpleasant off flavor. 56.31 Debarment. 2 ...... Repulsive flavor. 56.32 Retention authorities. 1 ...... Definite repulsive flavor. 0 ...... Pronounced repulsive flavor. IDENTIFYING AND MARKING PRODUCTS 56.35 Authority to use, and approval of offi- [36 FR 11795, June 19, 1971. Redesignated at 42 cial identification. FR 32514, June 27, 1977, and further redesig- 56.36 Form of grademark and information nated at 46 FR 63203, Dec. 31, 1981, as amend- required. ed at 47 FR 46070, Oct. 15, 1982; 47 FR 54421, 56.37 Lot marking of officially identified Dec. 3, 1982] product. 56.38 [Reserved]
PART 56—VOLUNTARY GRADING PREREQUISITES TO PACKAGING SHELL EGGS OF SHELL EGGS IDENTIFIED WITH CONSUMER GRADEMARKS 56.39 Quality assurance inspector required. Subpart A—Grading of Shell Eggs 56.40 Grading requirements of shell eggs identified with consumer grademarks. DEFINITIONS 56.41 Check grading officially identified Sec. product. 56.1 Meaning of words and terms defined. 56.42–56.43 [Reserved] 56.2 Designation of official certificates, memoranda, marks, other identifica- FEES AND CHARGES tions, and devices for purposes of the Ag- 56.45 Payment for fees and charges. ricultural Marketing Act. 56.46 On a fee basis. ADMINISTRATION 56.47 Fees for appeal grading or review of a grader’s decision. 56.3 Administration. 56.49 Travel expenses and other charges. 56.52 Continuous grading performed on a GENERAL resident basis. 56.4 Basis of grading service. 56.53 Fees or charges for grading service 56.5 Accessibility and condition of product. performed under cooperative agreement. 56.6 Supervision. 56.54 Charges for continuous grading per- 56.8 Other applicable regulations. formed on a nonresident basis. 56.9 OMB control numbers assigned pursu- ant to the Paperwork Reduction Act. GRADING CERTIFICATES 56.55 Grading certificates and sampling re- LICENSED GRADERS port forms. 56.10 Who may be licensed. 56.56 Grading certificate issuance. 56.11 Authorization to perform limited 56.57 Disposition of grading certificates. grading services. 56.58 Advance information.
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APPEAL OF A GRADING OR DECISION mercial practice in the United States, 56.60 Who may request an appeal grading or holding 30 dozens of shell eggs. review of a grader’s decision. Chief of the Grading Branch means the 56.61 Where to file an appeal. Chief of the Poultry Grading Branch of 56.62 How to file an appeal. the Poultry Division, Agricultural 56.63 When an application for an appeal Marketing Service. grading may be refused. 56.64 Who shall perform the appeal. Class means any subdivision of a 56.65 Procedures for appeal gradings. product based on essential physical 56.66 Appeal grading certificates. characteristics that differentiate be- tween major groups of the same kind, FACILITY REQUIREMENTS species, or method of processing. 56.75 Applicability of facility and operating Condition means any condition (in- requirements. cluding, but not being limited to, the 56.76 Minimum facility and operating re- state of preservation, cleanliness, quirements for shell egg grading and packing plants. soundness, wholesomeness, or fitness 56.77 Health and hygiene of personnel. for human food) of any product which affects its merchantability. AUTHORITY: 7 U.S.C. 1621–1627. Department means the United States Department of Agriculture. Subpart A—Grading of Shell Eggs Eggs of current production means shell eggs which have moved through usual DEFINITIONS marketing channels since the time § 56.1 Meaning of words and terms de- they were laid and have not been held fined. in refrigerated storage in excess of 30 For the purpose of the regulations in days. ‘‘Refrigerator or storage eggs’’ this part, words in the singular shall be means shell eggs which have been held deemed to import the plural and vice under refrigeration for a period of more versa, as the case may demand, and un- than 30 days. less the context otherwise requires, the Grader means any employee of the following terms shall be construed, re- Department authorized by the Sec- spectively, as follows: retary, or any other person to whom a Act means the applicable provisions license has been issued by the Sec- of the Agricultural Marketing Act of retary, to investigate and certify, in 1946 (60 Stat. 1087; 7 U.S.C. 1621 et seq.), accordance with the act and this part, or any other act of Congress conferring to shippers of products and other inter- like authority. ested parties the class, quality, quan- Administrator means the Adminis- tity, and condition of such products. trator of the Agricultural Marketing Grading or grading service means: (1) Service of the Department or any other The act whereby a grader determines, officer or employee of the Department according to the regulations in this to whom there has heretofore been del- part, the class, quality, quantity, or egated, or to whom there may here- condition of any product by examining after be delegated the authority to act each unit thereof or each unit of the in his stead. representative sample thereof drawn by Ambient temperature means the air a grader and issues a grading certifi- temperature maintained in an egg stor- cate with respect thereto, except that age facility or transport vehicle. with respect to grading service per- Applicant means an interested party formed on a resident basis the issuance who requests any grading service, ap- of a grading certificate shall be pursu- peal grading, or regrading with respect ant to a request therefor by the appli- to any product. cant or the Service; (2) the act whereby Cage mark means any stain-type the grader identifies, according to the mark caused by an egg coming in con- regulations in this part, the graded tact with a material that imparts a product; (3) continuous supervision, in rusty or blackish appearance to the an official plant, of the handling or shell. packaging of any product; and (4) any Case means, when referring to con- regrading or any appeal grading of a tainers, an egg case, as used in com- previously graded product.
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Grading certificate means a statement, supervise the labeling, dating, and either written or printed, issued by a lotting of officially graded shell eggs grader pursuant to the act and this and to assure that such product is part, relative to the class, quantity, packaged under sanitary conditions, quality, or condition of products. graded by authorized personnel, and Holiday or legal holiday shall mean maintained under proper inventory the legal public holidays specified by control until released by an employee the Congress in paragraph (a) of sec- of the Department. tion 6103, title 5, of the United States Regional director means any employee Code. of the Department in charge of the Interested party means any person fi- shell egg grading service in a des- nancially interested in a transaction ignated geographical area. involving any grading, appeal grading, Regulations means the provisions in or regrading of any product. this part. National supervisor means (1) the offi- Sampling means the act of taking cer in charge of the shell egg grading samples of any product for grading. service of the Agricultural Marketing Secretary means the Secretary of the Service, and (2) such other employees Department or any other officer or em- of the Service as may be designated by ployee of the Department to whom him. there has heretofore been delegated, or Nest run eggs means eggs which are to whom there may hereafter be dele- packed as they come from the produc- gated, the authority to act in his stead. tion facilities without having been Service means the Agricultural Mar- washed, sized and/or candled for qual- keting Service of the Department. ity, with the exception that some Shell eggs means shell eggs of domes- Checks, Dirties, or other obvious ticated chickens. undergrades may have been removed. Shell protected means eggs which have Office of grading means the office of had a protective covering such as oil any grader. applied to the shell surface. The prod- Official plant means any plant in uct used shall be acceptable to the which the facilities and methods of op- Food and Drug Administration. eration therein have been found by the Washed ungraded eggs means eggs Administrator to be suitable and ade- which have been washed but not sized quate for grading service in accordance or segregated for quality. with this part and in which grading [20 FR 669, Feb. 1, 1955] service is carried on. Origin grading is a grading made on a EDITORIAL NOTE: For FEDERAL REGISTER ci- lot of eggs at a plant where the eggs tations affecting § 56.1, see the List of CFR are graded and packed. Sections Affected, which appears in the Finding Aids section of the printed volume Person means any individual, part- and on GPO Access. nership, association, business trust, corporation, or any organized group of § 56.2 Designation of official certifi- persons, whether incorporated or not. cates, memoranda, marks, other Potable water means water that has identifications, and devices for pur- been approved by the State health au- poses of the Agricultural Marketing thority or agency or laboratory accept- Act. able to the Administrator as safe for Subsection 203(h) of the Agricultural drinking and suitable for food proc- Marketing Act of 1946, as amended by essing. Pub. L. 272, 84th Congress, provides Product or products means shell eggs criminal penalties for various specified of the domesticated chicken. offenses relating to official certifi- Quality means the inherent prop- cates, memoranda, marks or other erties of any product which determine identifications, and devices for making its relative degree of excellence. such marks or identifications, issued or Quality assurance inspector means any authorized under section 203 of said designated company employee other act, and certain misrepresentations than the plant owner, manager, fore- concerning the grading of agricultural man, or supervisor, authorized by the products under said section. For the Secretary to examine product and to purposes of said subsection and the
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provisions in this part, the terms listed ADMINISTRATION in this section shall have the respec- tive meanings specified: § 56.3 Administration. (a) Official certificate means any form (a) The Administrator shall perform, of certification, either written or print- for and under the supervision of the ed, used under this part to certify with Secretary, such duties as the Secretary respect to the sampling, class, grade, may require in the enforcement or ad- quality, size, quantity, or condition of ministration of the provisions of the products (including the compliance of Act and this part. The Administrator is products with applicable specifica- authorized to waive for limited periods tions). any particular provisions of the regula- (b) Official memorandum means any tions in this part to permit experimen- initial record of findings made by an tation so that new procedures, equip- authorized person in the process of ment, and processing techniques may grading or sampling pursuant to this be tested to facilitate definite improve- part, any processing or plant-operation ments and at the same time to deter- report made by an authorized person in mine full compliance with the spirit connection with grading or sampling and intent of the regulations in this under this part, and any report made part. The Agricultural Marketing Serv- by an authorized person of services per- ice and its officers and employees shall formed pursuant to this part. not be liable in damages through acts (c) Official mark means the of commission or omission in the ad- grademark and any other mark, or any ministration of this part. variations in such marks approved by (b) The conduct of all services and the Administrator and authorized to be the licensing of graders under these affixed to any product, or affixed to or regulations shall be accomplished printed on the packaging material of without discrimination as to race, any product, stating that the product color, national origin, religion, age, was graded, or indicating the appro- sex, or disability. priate U.S. grade or condition of the [20 FR 670, Feb. 1, 1955, as amended at 38 FR product, or for the purpose of main- 26798, Sept. 26, 1973; 42 FR 2970, Jan. 14, 1977. taining the identity of products graded Redesignated at 42 FR 32514, June 27, 1977, under this part, including but not lim- further redesignated at 46 FR 63203, Dec. 31, ited to, those set forth in § 56.36. 1981, as amended at 60 FR 12402, Mar. 7, 1995] (d) Official identification means any GENERAL United States (U.S.) standard designa- tion of class, grade, quality, size, quan- § 56.4 Basis of grading service. tity, or condition specified in this part (a) Any grading service in accordance or any symbol, stamp, label or seal in- with the regulations in this part shall dicating that the product has been offi- be for class, quality, quantity, or con- cially graded and/or indicating the dition or any combination thereof. class, grade, quality, size, quantity, or Grading service with respect to the de- condition of the product approved by termination of the quality of products the Administrator and authorized to be shall be on the basis of the ‘‘United affixed to any product, or affixed to or States Standards, Grades, and Weight printed on the packaging material of Classes’’ as contained in subpart C of any product. this part. However, grading service (e) Official device means a stamping may be rendered with respect to prod- appliance, branding device, stencil, ucts which are bought and sold on the printed label, or any other mechani- basis of institutional contract speci- cally or manually operated tool that is fications or specifications of the appli- approved by the Administrator for the cant and such service, when approved purpose of applying any official mark by the Administrator, shall be rendered or other identification to any product on the basis of such specifications. The or the packaging material thereof. supervision of packaging shall be in ac- [28 FR 6341, June 20, 1963. Redesignated at 42 cordance with such instructions as FR 32514, June 27, 1977, and further redesig- may be approved or issued by the Ad- nated at 46 FR 63203, Dec. 31, 1981] ministrator.
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(b) Whenever grading service is per- tion as is necessary to correct the formed on a representative sample grading and to cause any improper basis, such sample shall be drawn and grademarks which appear on the prod- consist of not less than the minimum uct or the containers thereof to be cor- number of cases as indicated in the fol- rected prior to shipment of the product lowing table. A minimum of one hun- from the place of initial grading. dred eggs shall be examined per sample [40 FR 20055, May 8, 1975. Redesignated at 42 case. For lots which consist of less FR 32514, June 27, 1977, as amended at 43 FR than 1 case, a minimum of 50 eggs shall 60138, Dec. 26, 1978. Redesignated at 46 FR be examined. If the lot consists of less 63203, Dec. 31, 1981] than 50 eggs, all eggs will be examined. § 56.8 Other applicable regulations. MINIMUM NUMBER OF CASES COMPRISING A Compliance with the regulations in REPRESENTATIVE SAMPLE this part shall not excuse failure to comply with any other Federal, or any Cases in lot Cases in sample State, or municipal applicable laws or 1 case ...... 1 regulations. 2 to 10, inclusive ...... 2 11 to 25, inclusive ...... 3 [20 FR 670, Feb. 1, 1955. Redesignated at 42 26 to 50, inclusive ...... 4 FR 32514, June 27, 1977, and further redesig- 51 to 100, inclusive ...... 5 nated at 46 FR 63203, Dec. 31, 1981] 101 to 200, inclusive ...... 8 201 to 300, inclusive ...... 11 § 56.9 OMB control numbers assigned 301 to 400, inclusive ...... 13 401 to 500, inclusive ...... 14 pursuant to the Paperwork Reduc- 501 to 600, inclusive ...... 16 tion Act. (a) Purpose. This section collects and For each additional 50 cases, or frac- displays the control numbers assigned tion thereof, in excess of 600 cases, one to information collection requirements additional case shall be included in the by the Office of Management and Budg- sample. et contained in 7 CFR part 56 pursuant [20 FR 670, Feb. 1, 1955, as amended at 22 FR to the Paperwork Reduction Act of 8167, Oct. 16, 1957; 28 FR 6342, June 20, 1963; 42 1980, Pub. L. 96–511. FR 2970, Jan. 14, 1977. Redesignated at 42 FR (b) Display. 32514, June 27, 1977, and further redesignated at 46 FR 63203, Dec. 31, 1981] Current 7 CFR section where identified and described OMB control number § 56.5 Accessibility and condition of product. 56.3(a) ...... 0581Ð0128 56.4(a) ...... 0581Ð0128 Each product for which grading serv- 56.10(a) ...... 0581Ð0128 ice is requested shall be so conditioned 56.11 ...... 0581Ð0128 and placed as to permit a proper deter- 56.12 ...... 0581Ð0128 56.17(b) ...... 0581Ð0128 mination of the class, quality, quan- 56.18 ...... 0581Ð0128 tity, or condition of such product. 56.21(a) ...... 0581Ð0128 56.21(b) ...... 0581Ð0128 [20 FR 670, Feb. 1, 1955, as amended at 27 FR 56.23 ...... 0581Ð0128 10317, Oct. 23, 1962. Redesignated at 42 FR 56.24 ...... 0581Ð0128 32514, June 27, 1977, and further redesignated 56.25 ...... 0581Ð0128 at 46 FR 63203, Dec. 31, 1981] 56.26 ...... 0581Ð0128 56.30 ...... 0581Ð0128 § 56.6 Supervision. 56.31(a) ...... 0581Ð0128 56.35(b) ...... 0581Ð0128 All grading service shall be subject to 56.35(c) ...... 0581Ð0128 supervision at all times by the applica- 56.37 ...... 0581Ð0128 56.52(a)(1) ...... 0581Ð0128 ble State supervisor, regional director 56.52(a)(4) ...... 0581Ð0128 and national supervisor. Such service 56.52(b)(1) ...... 0581Ð0128 shall be rendered where the facilities 56.52(b)(3)(ii) ...... 0581Ð0128 56.54(b)(1) ...... 0581Ð0128 and conditions are satisfactory for the 56.54(b)(3)(ii) ...... 0581Ð0128 conduct of the service and the requisite 56.56(a) ...... 0581Ð0128 graders are available. Whenever the su- 56.57 ...... 0581Ð0128 pervisor of a grader has evidence that 56.58 ...... 0581Ð0128 56.60 ...... 0581Ð0128 such grader incorrectly graded a prod- 56.62 ...... 0581Ð0128 uct, such supervisor shall take such ac- 56.76(e)(6) ...... 0581Ð0128
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Current shall thereafter be check graded by a 7 CFR section where identified and described OMB control grader. number
56.76(g) ...... 0581Ð0128 [42 FR 2970, Jan. 14, 1977. Redesignated at 42 FR 32514, June 27, 1977, and further redesig- nated at 46 FR 63203, Dec. 31, 1981] [48 FR 56565, Dec. 22, 1983, as amended at 52 FR 23935, June 26, 1987] § 56.12 Suspension of license; revoca- tion. LICENSED GRADERS Pending final action by the Sec- § 56.10 Who may be licensed. retary, any person authorized to coun- tersign a license to perform grading (a) Except as otherwise provided in service may, whenever he deems such paragraph (c) of this section, any per- action necessary to assure that any son who is a Federal or State em- grading service is properly performed, ployee, the employee of a local juris- suspend any license to perform grading diction, or the employee of a cooper- service issued pursuant to this part, by ating agency possessing proper quali- giving notice of such suspension to the fications as determined by an examina- respective licensee, accompanied by a tion for competency and who is to per- statement of the reasons therefor. form grading service under this part, Within 7 days after the receipt of the may be licensed by the Secretary as a aforesaid notice and statement of rea- grader. sons, the licensee may file an appeal in (b) All licenses issued by the Sec- writing, with the Secretary, supported retary shall be countersigned by the of- by any argument or evidence that he ficer in charge of the poultry grading may wish to offer as to why his license service of the Agricultural Marketing should not be further suspended or re- Service or any other designated officer voked. After the expiration of the of such Service. aforesaid 7-day period and consider- (c) No person may be licensed to ation of such argument and evidence, grade or sample any product in which the Secretary will take such action as he is financially interested. he deems appropriate with respect to such suspension or revocation. When [20 FR 670, Feb. 1, 1955, as amended at 28 FR no appeal is filed within the prescribed 6342, June 20, 1963; 37 FR 12918, June 30, 1972. 7 days, the license to perform grading Redesignated at 42 FR 32514, June 27, 1977, and further redesignated at 46 FR 63203, Dec. service is revoked. 31, 1981] [35 FR 19327, Dec. 22, 1970. Redesignated at 42 FR 32514, June 27, 1977, and further redesig- § 56.11 Authorization to perform lim- nated at 46 FR 63203, Dec. 31, 1981] ited grading services. Any person who is employed by any § 56.13 Cancellation of license. official plant and possesses proper Upon termination of his services as a qualifications, as determined by the grader, each licensee shall surrender Administrator, may be authorized to his license immediately for cancella- candle and grade eggs on the basis of tion. the ‘‘U.S. Standards for Quality of In- dividual Shell Eggs,’’ with respect to [42 FR 2970, Jan. 14, 1977. Redesignated at 42 eggs purchased from producers or eggs FR 32514, June 27, 1977, and further redesig- nated at 46 FR 63203, Dec. 31, 1981] to be packaged with official identifica- tion. In addition, such authorization § 56.14 Surrender of license. may be granted to any qualified person to act as a ‘‘quality assurance inspec- Each license which is canceled, sus- tor’’ in the packaging and grade label- pended, or has expired shall imme- ing of products. No person to whom diately be surrendered by the licensee such authorization is granted shall to the office of grading serving the area have authority to issue any grading in which he is located. certificates, grading memoranda, or [31 FR 2773, Feb. 16, 1966. Redesignated at 42 other official documents; and all eggs FR 32514, June 27, 1977, and further redesig- which are graded by any such person nated at 46 FR 63203, Dec. 31, 1981]
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§ 56.15 Political activity. containers and test weights for cali- All graders are forbidden during the brating such scales; period of their respective appointments (5) An acceptable candling light. or licenses, to take an active part in (b) Furnished office space, a desk and political management or in political file or storage cabinets (equipped with campaigns. Political activity in city, a satisfactory locking device), suitable county, State, or national elections, for the security and storage of official whether primary or regular, or in be- stamps and supplies, and other facili- half of any party or candidate, or any ties and equipment as may otherwise measure to be voted upon, is prohib- be required. Such space and equipment ited. This applies to all appointees, in- must meet the approval of the National cluding, but not being limited to, tem- supervisor. porary and cooperative employees, and employees on leave of absence with or [32 FR 8230, June 8, 1967. Redesignated at 42 without pay. Willful violation of this FR 32514, June 27, 1977, as amended at 46 FR section will constitute grounds for dis- 39570, Aug. 4, 1981. Redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 60 FR missal in the case of appointees and 12402, Mar. 7, 1995; 63 FR 13330, Mar. 19, 1998] revocation of licenses in the case of li- censees. § 56.18 Schedule of operation of offi- [42 FR 2970, Jan. 14, 1977. Redesignated at 42 cial plants. FR 32514, June 27, 1977, and further redesig- Grading operating schedules for serv- nated at 46 FR 63203, Dec. 31, 1981] ices performed pursuant to §§ 56.52 and § 56.16 Identification. 56.54 shall be requested in writing and be approved by the Administrator. Nor- All graders shall each have in posses- mal operating schedules for a full week sion at all times, and present upon re- consist of a continuous 8-hour period quest, while on duty, the means of per day (excluding not to exceed 1 hour identification furnished by the Depart- ment to such person. for lunch), 5 consecutive days per week, within the administrative workweek, [42 FR 2970, Jan. 14, 1977. Redesignated at 42 Sunday through Saturday, for each FR 32514, June 27, 1977, and further redesig- shift required. Less than 8-hour sched- nated at 46 FR 63203, Dec. 31, 1981] ules may be requested and will be ap- § 56.17 Facilities and equipment for proved if a grader is available. Clock graders. hours of daily operations need not be Facilities and equipment to be fur- specified in the request, although as a nished by the applicant for use of grad- condition of continued approval, the ers in performing service on a resident hours of operation shall be reasonably basis shall include (when deemed nec- uniform from day to day. Graders are essary) the following: to be notified by management 1 day in (a)(1) An accurate metal stem ther- advance of any change in the hours mometer; grading service is requested. (2) Electronic digital-display scales [48 FR 20683, May 9, 1983] graduated in increments of 1⁄10-ounce or less for weighing individual eggs and APPLICATION FOR GRADING test weights for calibrating such scales. Plants packing product based § 56.20 Who may obtain grading serv- on metric weight must provide scales ice. graduated in increments of 1-gram or An application for grading service less; may be made by any interested person, (3) Electronic digital-display scales including, but not being limited to, the graduated in increments of 1⁄4-ounce or less for weighing the lightest and United States, any State, county, mu- heaviest consumer packages packed in nicipality, or common carrier, and any the plant and test weights for cali- authorized agent of the foregoing. brating such scales; [42 FR 2970, Jan. 14, 1977. Redesignated at 42 (4) Scales graduated in increments of FR 32514, June 27, 1977, and further redesig- 1⁄4-pound or less for weighing shipping nated at 46 FR 63203, Dec. 31, 1981]
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§ 56.21 How application for service where such product is to be graded or may be made; conditions of service. sampled. (a) Noncontinuous grading service on a [28 FR 6342, June 20, 1963. Redesignated at 42 fee basis. An application for any non- FR 32514, June 27, 1977, and further redesig- continuous grading service on a fee nated at 46 FR 63203, Dec. 31, 1981] basis may be made in any office of grading, or with any grader at or near- § 56.24 When application may be re- jected. est the place where the service is de- sired. Such application may be made An application for grading service orally (in person or by telephone), in may be rejected by the Administrator writing, or by telegraph. If the applica- (a) whenever the applicant fails to tion for grading service is made orally, meet the requirements of the regula- the office of grading or the grader with tions prescribing the conditions under whom such application is made, or the which the service is made available; (b) Administrator, may require that the whenever the product is owned by or application be confirmed in writing. located on the premises of a person (b) Continuous grading service on a currently denied the benefits of the resident basis or continuous grading serv- act; (c) where any individual holding ice on a nonresident basis. An applica- office or a responsible position with or tion for continuous grading service on having a substantial financial interest a resident basis or for continuous grad- or share in the applicant is currently ing service on a nonresident basis must denied the benefits of the act or was re- be made in writing on forms approved sponsible in whole or in part for the by the Administrator and filed with current denial of the benefits of the act the Administrator. Such forms may be to any person; (d) where the Adminis- obtained at the national, regional, or trator determines that the application State grading office. In making appli- is an attempt on the part of a person cation, the applicant agrees to comply currently denied the benefits of the act with the terms and conditions of the to obtain grading services; (e) when- regulations (including, but not being ever the applicant fails to bring the limited to, such instructions governing plant facilities, and operating proce- grading of products as may be issued dures into compliance with the regula- from time to time by the Adminis- tions within a reasonable period of trator). No member of or Delegate to time; (f) notwithstanding any prior ap- Congress or Resident Commissioner proval whenever, before inauguration shall be admitted to any benefit that of service, the applicant fails to fulfill may arise from such service unless de- commitments concerning the inau- rived through service rendered a cor- guration of the service; (g) when it ap- poration for its general benefit. pears that to perform the services spec- ified in this part would not be to the [42 FR 2970, Jan. 14, 1977. Redesignated at 42 best interests of the public welfare or FR 32514, June 27, 1977, and further redesig- of the Government; or (h) when it ap- nated at 46 FR 63203, Dec. 31, 1981] pears to the Administrator that prior § 56.22 Filing of application. commitments of the Department ne- cessitate rejection of the application. An application for grading or sam- Each such applicant shall be promptly pling of a specified lot of any product notified by registered mail of the rea- shall be regarded as filed only when sons for the rejection. A written peti- made pursuant to this part. tion for reconsideration of such rejec- [28 FR 6342, June 20, 1963. Redesignated at 42 tion may be filed by the applicant with FR 32514, June 27, 1977, and further redesig- the Administrator if postmarked or de- nated at 46 FR 63203, Dec. 31, 1981] livered within 10 days after the receipt of notice of the rejection. Such peti- § 56.23 Form of application. tion shall state specifically the errors Each application for grading or sam- alleged to have been made by the Ad- pling a specified lot of any product ministrator in rejecting the applica- shall include such information as may tion. Within 20 days following the re- be required by the Administrator in re- ceipt of such a petition for reconsider- gard to the product and the premises ation, the Administrator shall approve
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the application or notify the applicant DENIAL OF SERVICE by registered mail of the reasons for the rejection thereof. § 56.31 Debarment. [28 FR 6342, June 20, 1963, as amended at 42 (a) The following acts or practices or FR 2970, Jan. 14, 1977. Redesignated at 42 FR the causing thereof may be deemed suf- 32514, June 27, 1977, and further redesignated ficient cause for the debarment by the at 46 FR 63203, Dec. 31, 1981] Administrator, of any person, includ- ing any agents, officers, subsidiaries or § 56.25 When application may be with- affiliates of such person, from all bene- drawn. fits of the act for a specific period. The An application for grading service rules of practice governing withdrawal may be withdrawn by the applicant at of grading services in formal adjudica- any time before the service is per- tory proceedings instituted by the Sec- formed upon payment, by the appli- retary (7 CFR, part 1, subpart H) shall cant, of all expenses incurred by the be applicable to such debarment ac- Service in connection with such appli- tion. cation. (1) Misrepresentation, deceptive, or fraudulent act or practice. Any willful [20 FR 671, Feb. 1, 1955. Redesignated at 42 FR 32514, June 27, 1977, and further redesig- misrepresentation or any deceptive or nated at 46 FR 63203, Dec. 31, 1981] fraudulent act or practice found to be made or committed by any person in § 56.26 Authority of applicant. connection with: Proof of the authority of any person (i) The making or filing of an appli- applying for any grading service may cation for any grading service or ap- be required at the discretion of the Ad- peal service; ministrator. (ii) The making of the product acces- sible for sampling or grading; [20 FR 671, Feb. 1, 1955. Redesignated at 42 (iii) The making, issuing, or using or FR 32514, June 27, 1977, and further redesig- attempting to issue or use any grading nated at 46 FR 63203, Dec. 31, 1981] certificate, symbol, stamp, label, seal, § 56.27 Order of service. or identification authorized pursuant to the regulations in this part; Grading service shall be performed, (iv) The use of the terms ‘‘United insofar as practicable, in the order in States’’ or ‘‘U.S.’’ in conjunction with which applications therefor are made the grade of the product; except that precedence may be given to (v) The use of any of the aforesaid any application for an appeal grading. terms or any official stamp, symbol, [20 FR 671, Feb. 1, 1955; 20 FR 757, Feb. 4, 1955, label, seal, or identification in the la- as amended at 42 FR 2970, Jan. 14, 1977. Re- beling or advertising of any product; or designated at 42 FR 32514, June 27, 1977, and (vi) The use of the terms ‘‘Govern- further redesignated at 46 FR 63203, Dec. 31, ment Graded,’’ ‘‘Federal-State Graded’’ 1981] or terms of similar import in the label- ing or advertising of any product. VIOLATIONS (2) Use of facsimile forms. Using or at- § 56.30 Report of violations. tempting to use a form which simu- lates in whole or in part any certifi- Each grader, shall report in the man- cate, symbol, stamp, label, seal or ner prescribed by the Administrator, identification authorized to be issued all violations and noncompliances or used under the regulations in this under the Act and this part of which part. such grader, has knowledge. (3) Willful violation of the regulations. [42 FR 2970, Jan. 14, 1977. Redesignated at 42 Any willful violation of the regulations FR 32514, June 27, 1977, and further redesig- in this part or the act. nated at 46 FR 63203, Dec. 31, 1981] (4) Interfering with a grader or em- ployee of the Service. Any interference with or obstruction or any attempted
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interference or obstruction of or as- product graded pursuant to this part is sault upon any grader, licensee, or em- granted only to applicants who make ployee of the Service in the perform- the services of a grader or quality as- ance of his duties. The giving or offer- surance inspector available for use in ing, directly or indirectly, of any accordance with this part. Packaging money, loan, gift, or anything of value materials bearing official identifica- to an employee of the Service or the tion marks shall be approved pursuant making or offering of any contribution to §§ 56.35 to 56.37, inclusive, and shall to or in any way supplementing the be used only for the purpose for which salary, compensation or expenses of an approved and prescribed by the Admin- employee of the Service or the offering istrator. Any unauthorized use or dis- or entering into a private contract or position of approved labels or pack- agreement with an employee of the aging materials which bear any official Service for any services to be rendered identification may result in cancella- while employed by the Service. tion of the approval and denial of the (5) Misleading labeling. The use of the use of labels or packaging materials terms ‘‘Government Graded’’, ‘‘Fed- bearing official identification or denial eral-State Graded’’, or terms of similar of the benefits of the Act pursuant to import in the labeling or advertising of the provisions of § 56.31. any product without stating in the (b) Approval of official identification. label or advertisement the U.S. grade No label, container, or packaging ma- of the product as determined by an au- terial which bears official identifica- thorized grader. tion may contain any statement that (6) Miscellaneous. The existence of is false or misleading. No label, con- any of the conditions set forth in § 56.24 tainer, or packaging material bearing constituting the basis for the rejection official identification may be printed of an application for grading service. or prepared for use until the printers’ or other final proof has been approved [20 FR 9895, Dec. 23, 1955, as amended at 28 FR 6343, June 20, 1963; 35 FR 5664, Apr. 8, 1970; by the Administrator in accordance 42 FR 2970, Jan. 14, 1977. Redesignated at 42 with the regulations in this part, the FR 32514, June 27, 1977, and further redesig- Federal Food, Drug, and Cosmetic Act, nated at 43 FR 60138, Dec. 26, 1978, and at 46 the Fair Packaging and Labeling Act, FR 63203, Dec. 31, 1981] and the regulations promulgated under these acts. The use of finished labels § 56.32 Retention authorities. must be approved as prescribed by the A grader may use retention tags or Administrator. A grader may apply of- other devices and methods as approved ficial identification stamps to shipping by the Administrator for the identi- containers if they do not bear any fication and control of shell eggs which statement that is false or misleading. are not in compliance with the regula- If the label is printed or otherwise ap- tions or are held for further examina- plied directly to the container, the tion and for any equipment, utensils, principal display panels of such con- rooms or compartments which are tainer shall for this purpose be consid- found unclean or otherwise in violation ered as the label. The label shall con- of the regulations. Any such item shall tain the name, address, and ZIP Code not be released until in compliance of the packer or distributor of the with the regulations and retention product, the name of the product, a identification shall not be removed by statement of the net contents of the anyone other than a grader. container, and the U.S. grademark. (c) Nutritional labeling. Nutrition in- [35 FR 5664, Apr. 8, 1970. Redesignated at 42 FR 32514, June 27, 1977, and further redesig- formation must be included with the nated at 46 FR 63203, Dec. 31, 1981] labeling on each unit container of con- sumer packaged shell eggs in accord- IDENTIFYING AND MARKING PRODUCTS ance with the provisions of Title 21, Chapter I, Part 101, Regulations for the § 56.35 Authority to use, and approval Enforcement of the Federal Food, of official identification. Drug, and Cosmetic Act and the Fair (a) Authority to use official identifica- Packaging and Labeling Act. The nu- tion. Authority to officially identify trition information included on labels
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is subject to review by the Food and contrasting colors in a manner such Drug Administration prior to approval that the design is legible and con- by the Department. spicuous on the material upon which it (d) Refrigeration labeling. All con- is printed. tainers bearing official U.S. Grade AA, (2) The size or weight class of the A, or B identification shall be labeled product, such as ‘‘Large,’’ may appear to indicate that refrigeration is re- within the grademark as shown in Fig- quired, e.g., ‘‘Keep Refrigerated,’’ or ure 3 of this section. If the size or words of similar meaning. weight class is omitted from the [40 FR 20055, May 8, 1975, as amended at 42 grademark, it must appear promi- FR 2970, Jan. 14, 1977. Redesignated at 42 FR nently on the main panel of the carton. 32514, June 27, 1977, and further redesignated (3) Except as otherwise authorized, at 46 FR 63203, Dec. 31, 1981, as amended at 60 the bands of the shield in Figure 4 of FR 12402, Mar. 7, 1995; 64 FR 56947, Oct. 22, 1999] this section shall be displayed in three colors, with the color of the top, mid- § 56.36 Form of grademark and infor- dle, and bottom bands being blue, mation required. white, and red, respectively. (a) Form of official identification sym- (4) The ‘‘Produced From’’ grademark bol and grademark. (1) The shield set in Figure 5 of this section may be any forth in Figure 1 of this section shall one of the designs shown in Figures 2 be the official identification symbol for through 4 of this section. The text out- purposes of this part and when used, side the shield shall be conspicuous, imitated, or simulated in any manner legible, and in approximately the same in connection with shell eggs, shall be proportion and close proximity to the deemed prima facia to constitute a rep- shield as shown in Figure 5 of this sec- resentation that the product has been tion. officially graded for the purposes of (5) The plant number of the official § 56.2. plant preceded by the letter ‘‘P’’ must (2) Except as otherwise authorized, be shown on each carton or packaging the grademark permitted to be used to material. officially identify USDA consumer- graded shell eggs shall be of the form and design indicated in Figures 2 through 4 of this section. The shield shall be of sufficient size so that the printing and other information con- tained therein is legible and in approxi- mately the same proportion as shown in these figures. (3) The ‘‘Produced From’’ grademark in Figure 5 of this section may be used to identify products for which there are no official U.S. grade standards (e.g., pasteurized shell eggs), provided that these products are approved by the Agency and are prepared from U.S. Consumer Grade AA or A shell eggs under the continuous supervision of a grader. (b) Information required on grademark. (1) Except as otherwise authorized by the Administrator, each grademark used shall include the letters ‘‘USDA’’ and the U.S. grade of the product it identifies, such as ‘‘A Grade,’’ as shown in Figure 2 of this section. Such infor- mation shall be printed with the shield and the wording within the shield in
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[63 FR 13330, Mar. 19, 1998]
§ 56.37 Lot marking of officially identi- fied product. Each carton identified with the grademarks shown in § 56.36 shall be legibly lot numbered on either the car- ton or the consumer package. The lot number shall be the consecutive day of the year on which the eggs were packed (e.g., 132), except other lot numbering systems may be used when submitted in writing and approved by the Admin- istrator. [35 FR 5664, Apr. 8, 1970. Redesignated at 42 FR 32514, June 27, 1977, as amended at 46 FR 39570, Aug. 4, 1981. Redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 60 FR 12402, Mar. 7, 1995; 63 FR 13331, Mar. 19, 1998]
§ 56.38 [Reserved]
PREREQUISITES TO PACKAGING SHELL EGGS IDENTIFIED WITH CONSUMER GRADEMARKS
§ 56.39 Quality assurance inspector re- quired. The official identification of any graded product as provided in §§ 56.35 to 56.41, inclusive, shall be done only under the supervision of a grader or quality assurance inspector. The grad- er or quality assurance inspector shall have supervision over the use and han- dling of all material bearing any offi- cial identification. [42 FR 2971, Jan. 14, 1977. Redesignated at 42 FR 32514, June 27, 1977, as amended at 46 FR 39570, Aug. 4, 1981. Redesignated at 46 FR 63203, Dec. 31, 1981]
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§ 56.40 Grading requirements of shell pursuant to paragraph (c) of this sec- eggs identified with consumer tion, be paid by check, draft, or money grademarks. order payable to the Agricultural Mar- (a) Shell eggs to be identified with keting Service and remitted promptly the grademarks illustrated in § 56.36 to the Service. must be individually graded by a grad- (c) Fees and charges for any grading er or by authorized personnel pursuant service under a cooperative agreement to § 56.11 and thereafter check graded with any State or person shall be paid by a grader. in accordance with the terms of such (b) Shell eggs not graded in accord- cooperative agreement. ance with paragraph (a) of this section may be officially graded on a sample [33 FR 20004, Dec. 31, 1968 and 42 FR 2971, Jan. 14, 1977. Redesignated at 42 FR 32514, June 27, basis and the shipping containers may 1977, and further redesignated at 46 FR 63203, be identified with grademarks which Dec. 31, 1981] contain the words ‘‘Sample Graded’’ and which are approved by the Admin- § 56.46 On a fee basis. istrator. (c) Shell eggs which are to bear the (a) Unless otherwise provided in this U.S. consumer grademark shall be part, the fees to be charged and col- packed only from eggs of current pro- lected for any service performed, in ac- duction. They shall not possess any un- cordance with this part, on a fee basis desirable odors or flavors. shall be based on the applicable rates specified in this section. [32 FR 8231, June 8, 1967. Redesignated at 42 (b) Fees for grading services will be FR 32514, June 27, 1977, as amended at 46 FR 39571, Aug. 4, 1981. Redesignated at 46 FR based on the time required to perform 63203, Dec. 31, 1981, as amended at 63 FR the services. The hourly charge shall 13331, Mar. 19, 1998] be $51.32 and shall include the time ac- tually required to perform the grading, § 56.41 Check grading officially identi- waiting time, travel time, and any fied product. clerical costs involved in issuing a cer- Officially identified shell eggs packed tificate. or received in an official plant may be (c) Grading services rendered on Sat- subject to final check grading prior to urdays, Sundays, or legal holidays their shipment. Such product found not shall be charged for at the rate of $59.12 to be in compliance with the assigned per hour. Information on legal holidays official grade shall be placed under a is available from the Supervisor. retention tag until it is regraded to comply with the grade assigned or [65 FR 57941, Sept. 27, 2000] until the official identification is re- moved. § 56.47 Fees for appeal grading or re- view of a grader’s decision. [35 FR 5664, Apr. 8, 1970. Redesignated at 42 FR 32514, June 27, 1977, and further redesig- The cost of an appeal grading or re- nated at 46 FR 63203, Dec. 31, 1981] view of a grader’s decision shall be borne by the appellant on a fee basis at §§ 56.42–56.43 [Reserved] rates set forth in § 56.46, plus any travel and additional expenses. If the appeal FEES AND CHARGES grading or review of a grader’s decision discloses that a material error was § 56.45 Payment for fees and charges. made in the original determination, no (a) Fees and charges for any grading fee or expenses will be charged. service shall be paid by the interested party making the application for such [63 FR 52133, Sept. 30, 1998] grading service, in accordance with the applicable provisions of this section § 56.49 Travel expenses and other and §§ 56.46 to 56.54, both inclusive; and, charges. if so required by the grader, such fees Charges are to be made to cover the and charges shall be paid in advance. cost of travel and other expenses in- (b) Fees and charges for any grading curred by the service in connection service shall, unless otherwise required with rendering grading service. Such
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charges shall include the cost of trans- porarily reassigned by AMS to perform portation, per diem, and any other ex- grading service for other than the ap- penses. plicant. Base salary rates will be deter- mined on a national average for all of- [42 FR 2971, Jan. 14, 1977. Redesignated at 42 FR 32514, June 27, 1977, as amended at 46 FR ficial plants operating in States under 8, Jan. 2, 1981. Redesignated at 46 FR 63203, a Federal Trust Fund Agreement where Dec. 31, 1981] Federal graders, State graders, or a combination of Federal and State grad- § 56.52 Continuous grading performed ers are used, by averaging the salary on a resident basis. rates paid to each Federal or State Fees to be charged and collected for grader assigned to such plants. Charges any grading service, other than for an to plants are as follows: appeal grading, on a resident grading (i) For all regular hours of work basis, shall be those provided in this scheduled and approved as an estab- section. The fees to be charged for any lished tour of duty for a plant, the reg- appeal grading shall be as provided in ular rate charge will be made. The reg- § 56.47. ular rate charge will be determined by (a) Charges. The charges for the grad- adding an amount to the base salary ing of shell eggs shall be paid by the rate to cover the costs to AMS for such applicant for the service and shall in- items as the Employer’s Tax imposed clude items listed in this section as are under the U.S. Internal Revenue Code applicable. Payment for the full cost of (26 U.S.C.) for Old Age and Survivor’s the grading service rendered to the ap- Benefits under the Social Security Sys- plicant shall be made by the applicant tem, retirement benefits, group life in- to Agricultural Marketing Service, surance, severance pay, sick leave, an- U.S. Department of Agriculture (here- nual leave, additional salary and travel inafter referred to as ‘‘AMS’’). Such costs for relief grading service, acci- full costs shall comprise such of the dent payments, certain moving costs, items listed in this section as are due and related servicing costs. and included in the bill or bills cov- (ii) All hours worked by an assigned ering the period or periods during grader or another grader in excess of which the grading service was ren- the approved tour of duty, or worked dered. Bills will be rendered by the 10th on a nonscheduled workday, or actu- day following the end of the period in ally worked on a holiday in excess of which the service was rendered and are the tour of duty, will be considered as payable upon receipt. overtime. The charge for such overtime (1) An inauguration charge of $310 will be 150 percent of the grader’s base will be made at the time an application salary rate. for service is signed except when the (iii) For work performed on a holiday application is required because of a which is within the established tour of change in name or ownership. If service duty approved for a plant, the added is not installed within 6 months from charge will be the same as the grader’s the date the application is filed, or if base rate. service is inactive due to an approved (iv) For work performed between 6 request for removal of a grader(s) for a p.m. and 6 a.m., night differential period of 6 months, the application will charges (for regular, overtime, or holi- be considered terminated, but a new day hours worked during this period) application may be filed at any time. will be at the applicable rates estab- In addition there will be a charge of lished plus 10 percent of the base rate. $300 if the application is terminated at (v) For work performed on Sunday, the request of the applicant for reasons Sunday differential charges (for reg- other than for a change in location, ular, overtime, or holiday hours within 12 months from the date of the worked on Sunday) will be at the appli- inauguration of service. cable rates established plus 25 percent (2) A charge for the salary and other of the base rate. costs, as specified in this paragraph, (vi) For all hours of work performed for each grader while assigned to a in a plant without an approved tour of plant, except that no charge will be duty, the charge will be one of the ap- made when the assigned grader is tem- plicable hourly rates in § 56.46.
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(3) A charge at the hourly rates spec- § 56.53 Fees or charges for grading ified in § 56.46, plus actual travel ex- service performed under coopera- penses incurred by AMS for inter- tive agreement. mediate surveys to firms without grad- Fees or charges to be made to an ap- ing service in effect. plicant for grading service which differ (4) An administrative service charge from those listed in §§ 56.45 through based upon the aggregate number of 30- 56.54 shall be provided for by a coopera- dozen cases of all shell eggs handled in tive agreement. the plant per billing period multiplied by $0.044, except that the minimum [36 FR 7894, Apr. 28, 1971. Redesignated at 42 charge per billing period shall be $225 FR 32514, June 27, 1977, and further redesig- and the maximum charge shall be nated at 46 FR 63203, Dec. 31, 1981] $2,625. The minimum charge also ap- § 56.54 Charges for continuous grading plies where an approved application is performed on a nonresident basis. in effect and no product is handled. (b) Other provisions. (1) The applicant Fees to be charged and collected for shall designate in writing the employ- grading service on a nonresident grad- ees of the applicant who will be re- ing basis, shall be those provided in quired and authorized to furnish each this section. The fees to be charged for grader with such information as may any appeal grading shall be as provided be necessary for the performance of the in § 56.47. grading service. (a) Charges. The charges for the grad- (2) AMS will provide, as available, an ing of shell eggs shall be paid by the adequate number of graders to perform applicant for the service and shall in- the grading service. The number of clude items listed in this section as are graders required will be determined by applicable. Payment for the full cost of AMS based on the expected demand for the grading service rendered to the ap- service. plicant shall be made by the applicant (3) The grading service shall be pro- to the Agricultural Marketing Service, vided at the designated plant and shall U.S. Department of Agriculture (here- be continued until the service is sus- inafter referred to as ‘‘AMS’’). Such pended, withdrawn, or terminated by: full costs shall comprise such of the (i) Mutual consent; items listed in this section as are due (ii) Thirty (30) days’ written notice, and included in the bill or bills cov- by either the applicant or AMS speci- ering the period or periods during fying the date of suspension, with- which the grading service was ren- drawal, or termination; dered. Bills will be rendered by the 10th (iii) One (1) day’s written notice by day following the end of the billing pe- AMS to the applicant if the applicant riod in which the service was rendered fails to honor any invoice within thirty and are payable upon receipt. (30) days after date of invoice covering (1) A charge for the salary and other the cost of the grading service; or costs, as specified in this paragraph, (iv) Action taken by AMS pursuant for each grader while assigned to a to the provisions of § 56.31. plant, except that no charge will be (4) Graders will be required to confine made when the assigned grader is tem- their activities to those duties nec- porarily reassigned by AMS to perform essary in the rendering of grading serv- grading service for other than the ap- ice and such closely related activities plicant. Base salary rates will be deter- as may be approved by AMS: Provided, mined on a national average for all of- That in no instance may the graders ficial plants operating in States under assume the duties of management. a Federal Trust Fund Agreement where [34 FR 8232, May 28, 1969] Federal graders, State graders, or a combination of Federal and State grad- EDITORIAL NOTE: For FEDERAL REGISTER ci- tations to § 56.52, see the List of CFR Sec- ers are used, by averaging the salary tions Affected, which appears in the Finding rates paid to each Federal or State Aids section of the printed volume and on grader assigned to such plants. Charges GPO Access. to plants are as follows:
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(i) For all regular hours of work be necessary for the performance of the scheduled and approved as an estab- grading service. lished tour of duty for a plant, the reg- (2) AMS will provide, as available, an ular rate charge will be made. The reg- adequate number of graders to perform ular rate charge will be determined by the grading service. The number of adding an amount to the base salary graders required will be determined by rate to cover the costs to AMS for such AMS based on the expected demand for items as the Employer’s Tax imposed service. under the U.S. Internal Revenue Code (3) The grading service shall be pro- (26 U.S.C.) for Old Age and Survivor’s vided at designated locations and shall Benefits under the Social Security Sys- be continued until the service is sus- tem, retirement benefits, group life in- pended, withdrawn, or terminated by: surance, severance pay, sick leave, an- (i) Mutual consent; nual leave, additional salary and travel (ii) Thirty (30) days’ written notice, costs for relief grading service, acci- by either the applicant or AMS speci- dent payments, certain moving costs, fying the date of suspension, with- and related servicing costs. drawal, or termination; (ii) All hours worked by an assigned (iii) One (1) day’s written notice by grader or another grader in excess of AMS to the applicant if the applicant the approved tour of duty, or worked fails to honor any invoice within thirty on a nonscheduled workday, or actu- (30) days after date of invoice covering ally worked on a holiday in excess of the cost of the grading service; or the tour of duty, will be considered as (iv) Action taken by AMS pursuant overtime. The charge for such overtime to the provisions of § 56.31. will be 150 percent of the grader’s base (4) Graders will be required to confine salary rate. their activities to those duties nec- (iii) For work performed on a holiday essary in the rendering of grading serv- which is within the established tour of ice and such closely related activities duty approved for a plant, the added as may be approved by AMS: Provided, charge will be the same as the grader’s That in no instance may the graders base rate. assume the duties of management. (iv) For work performed between 6 (5) When similar nonresident grading p.m. and 6 a.m., night differential services are furnished to the same ap- charges (for regular, overtime, or holi- plicant under part 55 or part 70 of this day hours worked during this period) chapter, the charges listed in this sec- will be at the applicable rates estab- tion shall not be repeated. lished plus 10 percent of the base rate. [35 FR 19327, Dec. 22, 1970] (v) For work performed on Sunday, EDITORIAL NOTE: For FEDERAL REGISTER ci- Sunday differential charges (for reg- tations to § 56.54, see the List of CFR Sec- ular, overtime, or holiday hours tions Affected, which appears in the Finding worked on Sunday) will be at the appli- Aids section of the printed volume and on cable rates established plus 25 percent GPO Access. of the base rate. (vi) For all hours of work performed GRADING CERTIFICATES in a plant without an approved tour of duty, the charge will be one of the ap- § 56.55 Grading certificates and sam- pling report forms. plicable hourly rates in § 56.46. (2) An administrative service charge Grading certificates and sampling re- equal to 25 percent of the grader’s total port forms shall be issued on forms ap- salary costs. A minimum charge of $260 proved by the Administrator. will be made each billing period. The [20 FR 673, Feb. 1, 1955. Redesignated at 42 minimum charge also applies where an FR 32514, June 27, 1977, and further redesig- approved application is in effect and no nated at 46 FR 63203, Dec. 31, 1981] product is handled. (b) Other provisions. (1) The applicant § 56.56 Grading certificate issuance. shall designate in writing the employ- (a) Resident grading basis. Certificates ees of the applicant who will be re- will be issued only upon request there- quired and authorized to furnish each for by the applicant or the Service. grader with such information as may When requested, a grader shall issue a
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certificate covering product graded by to any person designated by him, at his him. In addition, a grader may issue a expense. grading certificate covering product [20 FR 673, Feb. 1, 1955. Redesignated at 42 graded in whole or in part by another FR 32514, June 27, 1977, and further redesig- grader when the grader has knowledge nated at 46 FR 63203, Dec. 31, 1981] that the product is eligible for certifi- cation based on personal examination APPEAL OF A GRADING OR DECISION of the product or official grading records. SOURCE: Sections 56.60 through 56.66 appear (b) Other than resident grading. Each at 35 FR 9918, June 17, 1970, unless otherwise noted. Redesignated at 42 FR 32514, June 27, grader shall, in person or by his au- 1977, and further redesignated at 46 FR 63203, thorized agent, issue a grading certifi- Dec. 31, 1981. cate covering each product graded by him. A grader’s name may be signed on § 56.60 Who may request an appeal a grading certificate by a person other grading or review of a grader’s de- than the grader, if such person has cision. been designated as the authorized An appeal grading may be requested agent of such grader by the National by any interested party who is dissatis- Supervisor: Provided, That the certifi- fied with the determination by a grader cate is prepared from an official memo- of the class, quality, quantity, or con- randum of grading signed by the grad- dition of any product as evidenced by er: And provided further, That a nota- the USDA grademark and accom- rized power of attorney authorizing panying label, or as stated on a grading such signature has been issued to such certificate and a review may be re- person by the grader and is on file in quested by the operator of an official the office of grading. In such case, the plant with respect to a grader’s deci- authorized agent shall sign both his sion or on any other matter related to own and the grader’s name, e.g., ‘‘John grading in the official plant. Doe by Richard Roe.’’ § 56.61 Where to file an appeal. [36 FR 9841, May 29, 1971, as amended at 36 (a) Appeal from resident grader’s grad- FR 10937, June 5, 1971. Redesignated at 42 FR 32514, June 27, 1977, and further redesignated ing or decision in an official plant. Any at 46 FR 63203, Dec. 31, 1981] interested party who is not satisfied with the determination of the class, § 56.57 Disposition of grading certifi- quality, quantity, or condition of prod- cates. uct which was graded by a grader in an official plant and has not left such The original and a copy of each grad- plant, and the operator of any official ing certificate, issued pursuant to plant who is not satisfied with a deci- § 56.56, and not to exceed two additional sion by a grader on any other matter copies thereof if requested by the appli- related to grading in such plant may cant prior to issuance, shall, imme- request an appeal grading or review of diately upon issuance, be delivered or the decision by the grader by filing mailed to the applicant or person des- such request with the grader’s imme- ignated by him. Other copies shall be diate supervisor. filed and retained in accordance with (b) All other appeal requests. Any in- the disposition schedule for grading terested party who is not satisfied with program records. the class, quality, quantity, or condi- [36 FR 9842, May 29, 1971. Redesignated at 42 tion of product which has left the offi- FR 32514, June 27, 1977, and further redesig- cial plant where it was graded or which nated at 46 FR 63203, Dec. 31, 1981, as amend- was graded other than in an official ed at 47 FR 46070, Oct. 15, 1982; 47 FR 54421, plant may request an appeal grading by Dec. 3, 1982] filing such request in the area where the product is located or with the Chief § 56.58 Advance information. of the Grading Branch. Upon request of an applicant, all or part of the contents of any grading cer- § 56.62 How to file an appeal. tificate issued to such applicant may Any request for an appeal grading or be telephoned or telegraphed to him, or review of a grader’s decision may be
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made orally or in writing. If made oral- samples plus an equal number of sam- ly, written confirmation may be re- ples. quired. The applicant shall clearly (b) When the original samples are not state the reasons for requesting the ap- available, the appeal sample size for peal service and a description of the the lot shall consist of double the sam- product, or the decision which is ques- ples required in § 56.4(b). tioned. If such appeal request is based (c) Shell eggs shall not have been on the results stated on an official cer- moved from the original place of grad- tificate, the original and all available ing and must have been maintained copies of the certificate shall be re- under adequate refrigeration and hu- turned to the appeal grader assigned to midity conditions. make the appeal grading. [35 FR 9918, June 17, 1970. Redesignated at 42 § 56.63 When an application for an ap- FR 32514, June 27, 1977, and further redesig- peal grading may be refused. nated at 46 FR 63203, Dec. 31, 1981, as amend- ed at 47 FR 46070, Oct. 15, 1982; 47 FR 54421, When it appears to the official with Dec. 3, 1982] whom an appeal request is filed that the reasons given in the request are § 56.66 Appeal grading certificates. frivolous or not substantial, or that Immediately after an appeal grading the quality or condition of the product is completed, an appeal certificate has undergone a material change since shall be issued to show that the origi- the original grading, or that the origi- nal grading was sustained or was not nal lot has changed in some manner, or sustained. Such certificate shall super- the Act or the regulations in this part sede any previously issued certificate have not been complied with, the appli- for the product involved and shall cant’s request for the appeal grading clearly identify the number and date of may be refused. In such case, the appli- the superseded certificate. The cant shall be promptly notified of the issuance of the appeal certificate may reason(s) for such refusal. be withheld until any previously issued certificate and all copies have been re- § 56.64 Who shall perform the appeal. turned when such action is deemed nec- (a) An appeal grading or review of a essary to protect the interest of the decision requested under § 56.61(a) shall Government. When the appeal grader be made by the grader’s immediate su- assigns a different grade to the lot, the pervisor, or by a licensed grader as- existing grade mark shall be changed signed by the immediate supervisor or obliterated as necessary. When the other than the grader whose grading or appeal grader assigns a different class decision is being appealed. or quantity designation to the lot, the (b) Appeal gradings requested under labeling shall be corrected. § 56.61(b) shall be performed by a grader other than the grader who originally FACILITY REQUIREMENTS graded the product. (c) Whenever practical, an appeal § 56.75 Applicability of facility and op- grading shall be conducted jointly by erating requirements. two graders. The assignment of the The provisions of § 56.76 shall be ap- grader(s) who will make the appeal plicable to any grading service that is grading requested under § 56.61(b) shall provided on a resident basis. be made by the regional director or the [28 FR 6345, June 20, 1963. Redesignated at 42 Chief of the Grading Branch. FR 32514, June 27, 1977, and further redesig- [35 FR 9918, June 17, 1970, as amended at 40 nated at 46 FR 63203, Dec. 31, 1981] FR 20056, May 8, 1975. Redesignated at 42 FR 32514, June 27, 1977, and further redesignated § 56.76 Minimum facility and operating at 46 FR 63203, Dec. 31, 1981] requirements for shell egg grading and packing plants. § 56.65 Procedures for appeal (a) General requirements for buildings gradings. and plant facilities. (1) Buildings shall (a) When all of the originally graded be of sound construction so as to pre- and identified samples are available, vent, insofar as practicable, the en- the appeal sample shall consist of such trance or harboring of vermin.
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(2) Grading and packing rooms shall shall be constructed to permit clean- be of sufficient size to permit installa- ing; operation in a clean, sanitary tion of necessary equipment and the manner; and shall be capable of ready conduct of grading and packing in a adjustment. sanitary manner. These rooms shall be (5) Adequate ventilation shall be pro- kept reasonably clean during grading vided. and packing operations and shall be (c) Cooler room requirements. (1) Cooler thoroughly cleaned at the end of each rooms shall be refrigerated and capable operating day. of maintaining an ambient tempera- (3) Adequate lavatory and toilet ac- ture no greater than 45 °F (7.2 °C). Ac- commodations shall be provided. Toilet curate thermometers shall be provided and locker rooms shall be maintained for monitoring cooler room tempera- in a clean and sanitary condition. Hot tures. and cold running water shall be pro- (2) Cooler rooms shall be free from vided. Rooms shall be ventilated to the objectionable odors and from mold, and outside of the building. Signs shall be shall be maintained in a sanitary con- posted in the rest rooms instructing dition. employees to wash their hands before (3) All shell egg coolers shall be returning to work. equipped with a hygrometer or port- (4) A separate refuse room or a des- able equipment such as a psychrometer ignated area for the accumulation of shall be available to determine the rel- trash must be provided in plants which ative humidity. Humidifying equip- do not have a system for the daily re- ment capable of maintaining a relative moval or destruction of such trash. humidity which will minimize shrink- (5) Wood benches, platforms, etc., in age shall be provided. areas which are subjected to moisture (d) Shell egg protecting operations. and which develop odors shall be re- Shell egg protecting (oil processing) placed with equipment of metal con- operations shall be conducted in a struction. Wood walls or partitions manner to avoid contamination of the which develop odors shall be replaced product and maximize conservation of with materials impervious to moisture. its quality. Newly constructed plants should be (1) Eggs with excess moisture on the equipped with metal benches, plat- shell shall not be shell protected. forms, etc., in areas which are sub- (2) Oil having any off odor, or that is jected to moisture. obviously contaminated, shall not be (b) Grading room requirements. (1) The used in shell egg protection. egg grading or candling area shall be (3) Processing oil that has been pre- adequately darkened to make possible viously used and which has become the accurate quality determination of contaminated shall be filtered and heat the candled appearance of eggs. There treated at 180 °F. for 3 minutes prior to shall be no other light source or reflec- use. tions of light that interfere with, or (4) Shell egg processing equipment prohibit the accurate quality deter- shall be washed, rinsed, and treated mination of eggs in the grading or can- with a bactericidal agent each time the dling area. oil is removed. It is preferable to filter (2) The grading and candling equip- and heat treat processing oil and clean ment shall provide adequate light to processing equipment daily when in facilitate quality determinations. use. Other light sources and equipment or (5) Adequate coverage and protection facilities shall be provided to permit against dust and dirt shall be provided the detection and removal of stained when the equipment is not in use. and dirty eggs or other undergrade (e) Shell egg cleaning operations. (1) eggs. Shell egg cleaning equipment shall be (3) Adequate facilities, equipment, kept in good repair and shall be and light sources shall be provided to cleaned after each day’s use or more determine the condition of packing frequently, if necessary. material. (2) The temperature of the wash (4) Egg weighing equipment shall be water shall be maintained at 90 °F. or provided. The egg weighing equipment higher, and shall be at least 20 °F.
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warmer than the temperature of the (10) Washed eggs shall be spray-rinsed eggs to be washed. These temperatures with water having a temperature equal shall be maintained throughout the to, or warmer than, the temperature of cleaning cycle. the wash water and contain an ap- (3) An approved cleaning compound proved sanitizer of not less than 50 p/m shall be used in the wash water. (The nor more than 200 p/m of available use of metered equipment for dis- chlorine or its equivalent. Alternate pensing the compound into solution is procedures, in lieu of a sanitizer rinse, recommended.) may be approved by the National Su- (4) Wash water shall be changed ap- pervisor. proximately every 4 hours or more (11) Test kits shall be provided and often if needed to maintain sanitary used to determine the strength of the conditions, and at the end of each shift. sanitizing solution. Remedial measures shall be taken to (12) During any rest period, eggs shall prevent excess foaming during the egg be removed from the washing and rins- washing operation. ing area of the egg washer and from the (5) Replacement water shall be added scanning area whenever there is a continuously to the wash water of buildup of heat. washers. Rinse water, chlorine, or qua- (13) Washed eggs shall be reasonably ternary sanitizing rinse may be used as dry before cartoning or casing. part of the replacement water, pro- (14) When steam or vapors originate vided, they are compatible with the from the washing operation, they shall washing compound. Iodine sanitizing be continuously and directly removed rinse may not be used as part of the re- to the outside of the building. placement water. (f) Requirements for eggs that are to be (6) Only potable water may be used to officially identified. (1) Shell eggs that wash eggs. Each official plant shall are to be officially identified as U.S. submit certification to the national of- Grade AA, A, or B shall be placed under fice stating that their water supply is refrigeration at an ambient tempera- potable. An analysis of the iron con- ture no greater than 45 °F (7.2 °C) tent of the water supply, stated in promptly after packaging. Shell eggs parts per million, is also required. officially identified as U.S. Grade AA, When the iron content exceeds 2 parts A, or B, when shipped between official per million, equipment shall be pro- vided to correct the excess iron con- plants, shall be transported at an ambi- ° tent. Frequency of testing shall be de- ent temperature no greater than 45 F ° termined by the Administrator. When (7.2 C). the water source is changed, new tests (2) Every reasonable precaution shall are required. be exercised to prevent ‘‘sweating’’ of (7) Waste water from the egg washing eggs. operation shall be piped directly to (3) Eggs that are to be officially iden- drains. tified as U.S. Grade AA, A, or B shall (8) The washing and drying operation be packaged only in new or good used shall be continuous and shall be com- cases and packing materials. Cases and pleted as rapidly as possible. Eggs shall packing materials must be reasonably not be allowed to stand or soak in clean, free of mold, mustiness, and off water. Immersion-type washers shall odors, and must be of sufficient not be used. strength and durability to adequately (9) Prewetting shell eggs prior to protect the eggs during normal dis- washing may be accomplished by tribution. spraying a continuous flow of water (g) The following substances used in over the eggs in a manner which per- the plant shall be approved and han- mits the water to drain away or other dled in accordance with the manufac- methods which may be approved by the turer’s instructions: Pesticides, insec- Administrator. The temperature of the ticides, rodenticides, cleaning com- water shall be the same as prescribed pounds, destaining compounds, foam in this section. control compounds, sanitizers, and
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inks and oils coming into contact with EXEMPTIONS the product. 57.100 Specific exemptions. [20 FR 674, Feb. 1, 1955, as amended at 22 FR 57.105 Suspension or termination of exemp- 8168, Oct. 16, 1957; 28 FR 6346, June 20, 1963; 32 tions. FR 8232, June 8, 1967; 35 FR 5664, Apr. 8, 1970; PERFORMANCE OF SERVICE 40 FR 20056, May 8, 1975. Redesignated at 42 FR 32514, June 27, 1977, as amended at 46 FR 57.110 Licensed inspectors. 39571, Aug. 4, 1981. Redesignated at 46 FR 57.112 Suspension of license or authority; 63203, Dec. 31, 1981, as amended at 47 FR revocation. 46070, Oct. 15, 1982; 47 FR 54421, Dec. 3, 1982; 57.114 Surrender of license. 60 FR 12402, Mar. 7, 1995; 63 FR 13331, Mar. 19, 57.116 Activities of inspectors. 1998; 64 FR 56947, Oct. 22, 1999] 57.118 Identification. 57.119 Political activity. § 56.77 Health and hygiene of per- 57.120 Financial interest of inspectors. sonnel. 57.132 Access to plants. 57.134 Accessibility of product. (a) No person known to be affected by a communicable or infectious disease RECORDS AND RELATED REQUIREMENTS FOR shall be permitted to come in contact EGG HANDLERS AND RELATED INDUSTRIES with the product. 57.200 Records and related requirements. (b) Plant personnel coming into con- 57.220 Information and assistance to be fur- tact with the product shall wear clean nished to inspectors. clothing. ADMINISTRATIVE DETENTION [32 FR 8232, June 8, 1967. Redesignated at 42 57.240 Detaining product. FR 32514, June 27, 1977, and further redesig- nated at 46 FR 63203, Dec. 31, 1981] APPEAL OF AN INSPECTION OR DECISION 57.300 Who may request an appeal inspec- PART 57—INSPECTION OF EGGS tion or review of an inspector’s decision. (EGG PRODUCTS INSPECTION ACT) 57.310 Where to file an appeal. 57.320 How to file an appeal. Subpart A—Regulations Governing the 57.330 When an application for an appeal Inspection of Eggs grading or inspection may be refused. 57.340 Who shall perform the appeal. DEFINITIONS 57.350 Procedures for selecting appeal sam- ples. Sec. 57.360 Appeal inspection certificates. 57.1 Meaning of words. 57.370 Cost of appeals. 57.5 Terms defined. IDENTIFYING AND MARKING PRODUCT ADMINISTRATION 57.410 Shell eggs required to be labeled. 57.10 Authority. 57.13 Federal and State cooperation. RETENTION 57.17 Nondiscrimination. 57.426 Retention. 57.18 OMB control number. PROCESSING REQUIREMENTS SCOPE OF INSPECTION 57.504 General operating procedures. 57.20 Inspection in accordance with methods prescribed or approved. REGISTRATION OF SHELL EGG HANDLERS 57.22 Basis of service. 57.690 Persons required to register. 57.28 Other inspections. INSPECTION AND DISPOSITION OF RESTRICTED RELATION TO OTHER AUTHORITIES EGGS 57.35 Eggs outside official plants. 57.700 Prohibition on disposition of re- stricted eggs. EGGS AND EGG PRODUCTS NOT INTENDED FOR 57.720 Disposition of restricted eggs. HUMAN FOOD 57.760 Inspection of egg handlers. 57.45 Prohibition on eggs and egg products not intended for use as human food. IDENTIFICATION OF RESTRICTED EGGS OR EGG PRODUCTS NOT INTENDED FOR HUMAN CON- REFRIGERATION OF SHELL EGGS SUMPTION 57.50 Temperature and labeling Require- 57.800 Identification of restricted eggs. ments. 57.801 Nest run or washed ungraded eggs.
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57.840 Identification of inedible, unwhole- Subpart A—Regulations some, or adulterated egg products. 57.860 Identification wording. Governing the Inspection of Eggs
IMPORTS DEFINITIONS 57.900 Requirements for importation of re- § 57.1 Meaning of words. stricted eggs into the United States. 57.905 Importation of restricted eggs or eggs Under these regulations, words in the containing more restricted eggs than singular shall be deemed to mean the permitted in the official standards for plural and vice versa, as the case may U.S. Consumer Grade B. demand. 57.915 Foreign inspection certification re- quired. § 57.5 Terms defined. 57.920 Importer to make application for in- For the purpose of these regulations, spection of imported eggs. unless the context otherwise requires, 57.925 Inspection of imported eggs. the following terms shall be construed, 57.930 Imported eggs; retention in customs custody; delivery under bond; movement respectively, as follows: prior to inspection; sealing; handling; fa- Acceptable means suitable for the pur- cilities, and assistance. pose intended and acceptable to the 57.935 Means of conveyance and equipment Administrator. used in handling eggs to be maintained Act means the applicable provisions in sanitary condition. of the Egg Products Inspection Act 57.945 Foreign eggs offered for importation; (Pub. L. 91–597, 84 Stat. 1620 et seq.). reporting of findings to customs; han- Administrator means the Adminis- dling of products refused entry. trator of the Agricultural Marketing 57.950 Labeling of containers of eggs for im- Service of the Department or any other portation. 57.955 Labeling of shipping containers of officer or employee of the Department eggs for importation. to whom there has heretofore been del- 57.960 Small importations for consignee’s egated, or to whom there may here- personal use, display, or laboratory anal- after be delegated the authority to act ysis. in his stead. 57.965 Returned U.S. inspected and marked Adulterated means any egg or egg products; not importations. product under one or more of the fol- 57.970 Charges for storage, cartage, and lowing circumstances: labor with respect to products imported (a) If it bears or contains any poi- contrary to the Act. sonous or deleterious substance which may render it injurious to health; but Subpart B—Rules of Practice Governing in case the substance is not an added Proceedings Under the Egg Products substance, such article shall not be Inspection Act considered adulterated under this SCOPE AND APPLICABILITY OF RULES OF clause if the quantity of such sub- PRACTICE stance in or on such article does not ordinarily render it injurious to health; 57.1000 Administrative proceedings. (b)(1) If it bears or contains any AUTHORITY: 21 U.S.C. 1031–1056. added poisonous or added deleterious SOURCE: 63 FR 69968, Dec. 17, 1998, unless substance (other than one which is (i) a otherwise noted. pesticide chemical in or on a raw agri- cultural commodity; (ii) a food addi- EDITORIAL NOTE: 1. At 63 FR 69969, Dec. 17, tive; or (iii) a color additive) which 1998, part 57 was added by duplicating por- tions of part 59. At 63 FR 72353, Dec. 31, 1998, may in the judgment of the Secretary, part 59 was redesignated as part 590 of 9 CFR. make such article unfit for human food; 2. Nomenclature changes to part 57 appear at 63 FR 69971, Dec. 17, 1998. (2) If it is, in whole or in part, a raw agricultural commodity and such com- modity bears or contains a pesticide chemical which is unsafe within the meaning of section 408 of the Federal Food, Drug, and Cosmetic Act;
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(3) If it bears or contains any food ad- thorized under the Act or the regula- ditive which is unsafe within the mean- tions of this part. ing of section 409 of the Federal Food, Capable of use as human food means Drug, and Cosmetic Act; any egg or egg product, unless it is de- (4) If it bears or contains any color natured, or otherwise identified, as re- additive which is unsafe within the quired by these regulations to deter its meaning of section 706 of the Federal use as human food. Food, Drug, and Cosmetic Act: Pro- Chief of the Grading Branch means vided, that an article which is not oth- Chief of the Poultry Grading Branch, erwise deemed adulterated under para- Poultry Division, Agricultural Mar- graph (b)(2), (3), or (4) of this definition keting Service. shall nevertheless be deemed adulter- Class means any subdivision of a ated if use of the pesticide chemical, product based on essential physical food additive, or color additive, in or characteristics that differentiate be- on such article, is prohibited by regula- tween major groups of the same kind, tions of the Secretary in official type, or method of processing. plants; Commerce means interstate, foreign, (c) If it consists in whole or in part of or intrastate commerce. any filthy, putrid, or decomposed sub- Condition means any condition (in- stance, or if it is otherwise unfit for cluding, but not being limited to, the human food; state of preservation, cleanliness, soundness, wholesomeness, or fitness (d) If it has been prepared, packaged, for human food) of any product which or held under insanitary conditions affects its merchantability; or any con- whereby it may have become contami- dition, including but not being limited nated with filth, or whereby it may to, the processing, handling, or pack- have been rendered injurious to health; aging which affects such product. (e) If it is an egg which has been sub- Container or Package includes for egg jected to incubation or the product of products, any box, can, tin, plastic, or any egg which has been subjected to in- other receptacle, wrapper, or cover and cubation; for shell eggs, any carton, basket, case, (f) If its container is composed, in cart, pallet, or other receptacle. whole or in part of any poisonous or (a) Immediate container means any deleterious substance which may package or other container in which render the contents injurious to egg products or shell eggs are packed health; for household or other ultimate con- (g) If it has been intentionally sub- sumers. jected to radiation, unless the use of (b) Shipping container means any con- the radiation was in conformity with a tainer used in packing an immediate regulation or exemption in effect pur- container. suant to section 409 of the Federal Department means the U.S. Depart- Food, Drug, and Cosmetic Act; or ment of Agriculture. (h) If any valuable constituent has Dirty egg or Dirties means an egg(s) been, in whole or in part, omitted or that has an unbroken shell with adher- abstracted therefrom; or if any sub- ing dirt or foreign material. stance has been substituted, wholly or Egg means the shell egg of the do- in part therefor; or if damage or inferi- mesticated chicken, turkey, duck, ority has been concealed in any man- goose, or guinea. Some of the terms ap- ner; or if any substance has been added plicable to shell eggs are as follows: thereto or mixed or packed therewith (a) Check means an egg that has a so as to increase its bulk or weight, or broken shell or crack in the shell but reduce its quality or strength, or make has its shell membranes intact and it appear better or of greater value contents not leaking. than it is. (b) Clean and sound shell egg means Ambient temperature means the air any egg whose shell is free of adhering temperature maintained in an egg stor- dirt or foreign material and is not age facility or transport vehicle. cracked or broken. Applicant means any person who re- (c) Dirty egg or Dirties means an quests any inspection service as au- egg(s) that has a shell that is unbroken
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and has adhering dirt, foreign material, dip, cake mixes, French toast, and or prominent stains. sandwiches containing eggs or egg (d) Incubator reject means an egg that products, provided, such products are has been subjected to incubation and prepared from inspected egg products has been removed from incubation dur- or eggs containing no more restricted ing the hatching operations as infertile eggs than are allowed in the official or otherwise unhatchable. standards for U.S. Consumer Grade B (e) Inedible means eggs of the fol- shell eggs. Balut and other similar eth- lowing descriptions: Black rots, yellow nic delicacies are also exempted from rots, white rots, mixed rots, sour eggs, inspection under this part. eggs with green whites, eggs with Eggs of current production means shell stuck yolks, moldy eggs, musty eggs, eggs which have moved through the eggs showing blood rings, and eggs con- usual marketing channels since the taining embryo chicks (at or beyond time they were laid and are not in ex- the blood ring stage). cess of 60 days old. (f) Leaker means an egg that has a crack or break in the shell and shell Fair Packaging and Labeling Act membranes to the extent that the egg means the Act so entitled, approved contents are exposed or are exuding or November 3, 1966 (80 Stat. 1296), and free to exude through the shell. Acts amendatory thereof or supple- (g) Loss means an egg that is unfit for mentary thereto. human food because it is smashed or Federal Food, Drug, and Cosmetic Act broken so that its contents are leak- means the Act so entitled, approved ing; or overheated, frozen, or contami- June 25, 1938 (52 Stat. 1040), and Acts nated; or an incubator reject; or be- amendatory thereof or supplementary cause it contains a bloody white, large thereto. meat spots, a large quantity of blood, Inspection means the application of or other foreign material. such inspection methods and tech- (h) Restricted egg means any check, niques as are deemed necessary by the dirty egg, incubator reject, inedible, responsible Secretary to carry out the leaker, or loss. provisions of the Egg Products Inspec- Egg handler means any person, ex- tion Act and the regulations under this cluding the ultimate consumer, who part. engages in any business in commerce Inspection service means the official that involves buying or selling any service within the Department having eggs (as a poultry producer or other- the responsibility for carrying out the wise), or processing any egg products, provisions of the Egg Products Inspec- or otherwise using any eggs in the tion Act. Inspection service also means preparation of human food. the activities performed, including offi- Egg product means any dried, frozen, cial reporting by such official service. or liquid eggs, with or without added Inspector/Grader means: ingredients, excepting products which (a) Any employee or official of the contain eggs only in a relatively small United States Government authorized proportion or historically have not been, in the judgment of the Secretary, to inspect eggs or egg products under considered by consumers as products of the authority of this part; or the egg food industry, and which may (b) Any employee or official of the be exempted by the Secretary under government of any State or local juris- such conditions as he may prescribe to diction authorized by the Secretary to assure that the egg ingredients are not inspect eggs or egg products under the adulterated and such products are not authority of this part, under an agree- represented as egg products. For the ment entered into between the Sec- purposes of this part, the following retary and the appropriate State or products, among others, are exempted other agency. as not being egg products: Freeze-dried Interested party means any person fi- products, imitation egg products, egg nancially interested in a transaction substitutes, dietary foods, dried no- involving any inspection or appeal in- bake custard mixes, egg nog mixes, spection of any product, or the decision acidic dressings, noodles, milk and egg of an inspector.
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Label means a display of any printed, shall have the same meaning for pur- graphic, or other method of identifica- poses of this part as under the Federal tion upon the shipping container, if Food, Drug, and Cosmetic Act. any, or upon the immediate container, Plant means any place of business including but not limited to, an indi- where egg products are processed: vidual consumer package of eggs and (a) Exempted plant means any plant egg products, or accompanying such where the Administrator has deter- product. mined the facilities and operating pro- Misbranded means any egg products cedures meet such standards as may be which are not labeled and packaged in prescribed by this part, and where the accordance with the requirements pre- eggs received or used in the manufac- scribed by regulations of the Adminis- ture of egg products contain no more trator under this part. restricted eggs than are allowed by the National Supervisor means: official standards of U.S. Consumer (a) The officer in charge of the in- Grade B for shell eggs, and where an spection service; and exemption has been granted. (b) Such other employee of the Serv- (b) Official plant means any plant in ice as may be designated by him. which the plant facilities, methods of Nest-run eggs means eggs which are operation and sanitary procedures have packed as they come from the produc- been found suitable and adequate by tion facilities without having been the Administrator for the continuous washed, sized and/or candled for qual- inspection of egg products in accord- ity, with the exception that some ance with this part and in which in- checks, dirties, or other obvious under- spection service is carried on. grades may have been removed. Potable water means water that has Official certificate means any certifi- been approved by a State health au- cate prescribed by regulations of the thority or other agency or laboratory Administrator for issuance by an in- acceptable to the Administrator as safe spector or other person performing offi- for drinking and suitable for food proc- cial functions under this part. essing. Official device means any device pre- Processing means manufacturing of scribed or authorized by the Secretary egg products, including breaking eggs for use in applying any official mark. or filtering, mixing, blending, pasteur- Official identification means the offi- izing, stabilizing, cooling, freezing or cial inspection mark or any other sym- drying, or packaging egg products at bol prescribed by regulations of this official plants. part to identify the status of any arti- cle. Producer-packer means any producer who sorts eggs only from his own pro- Official inspection mark means any symbol prescribed by the regulations of duction and packs them into their var- the Administrator showing that egg ious qualities. products were inspected in accordance Quality means the inherent prop- with this part. erties of any product which determine Official standards means the stand- its relative degree of excellence. ards of quality, grades, and weight Regional Director means any employee classes for eggs. of the Department in charge of inspec- Office of inspection means the office of tion service in a designated geo- any inspector. graphical region. Pasteurize means the subjecting of Regulations means the provisions in each particle of egg products to heat or this part. other treatments to destroy harmful Regulatory inspector means any em- viable microorganisms by such proc- ployee of the U.S. Government, or esses as may be prescribed by these State or local jurisdiction, who is au- regulations. thorized by the Secretary to make such Person means any individual, part- inspections as required in § 57.28 of nership, corporation, association, or these regulations. other business unit. Sampling means the act of taking Pesticide chemical, Food additive, Color samples of any product for inspection additive, and Raw agricultural commodity or analyses.
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Sanitize means the application of a § 57.13 Federal and State cooperation. bactericidal treatment which is ap- The Secretary shall, whenever he de- proved as being effective in destroying termines that it would effectuate the microorganisms, including pathogens. purposes of the Act, authorize the Ad- Secretary means the Secretary of Ag- riculture or his delegate. ministrator to cooperate with appro- Service means the Agricultural Mar- priate State and other governmental keting Service (AMS) of the Depart- agencies in carrying out any provisions ment. of the Egg Products Inspection Act and Shell egg packer (grading station) these regulations. In carrying out the means any person engaged in the sort- provisions of the Act and the regula- ing of eggs from sources other than or tions, the Secretary may conduct such in addition to his own production into examinations, investigations, and in- their various qualities, either mechani- spections as he determines practicable cally or by other means. through any officer or employee of any Stabilization means the subjection of such agency commissioned by him for any egg product to a desugaring proc- such purpose. The Secretary shall re- ess. imburse the States and other agencies State means any State of the United for the services rendered by them in States, the Commonwealth of Puerto such cooperative programs as agreed to Rico, the Virgin Islands of the United in the cooperative agreements as States, and the District of Columbia. signed by the Administrator and the Ultimate consumer means any house- duly authorized agent of the State or hold consumer, restaurant, institution, other agency. or any other party who has purchased or received shell eggs or egg products § 57.17 Nondiscrimination. for consumption. The conduct of all services and the li- United States means the States. censing of graders and inspectors under Washed ungraded eggs means eggs these regulations shall be accom- which have been washed but not sized plished without discrimination as to or segregated for quality. race, color, religion, sex, national ori- White or albumen means, for the pur- gin, age, or disability. pose of this part, the product obtained from the egg as broken from the shell § 57.18 OMB control number. and separated from the yolk. The information collection require- [63 FR 69968, 69970, Dec. 17, 1998] ments in this part have been approved by the Office of Management and Budg- ADMINISTRATION et and assigned OMB control number 0581–0113. § 57.10 Authority. [63 FR 69970, Dec. 17, 1998] The Administrator shall perform, for and under the supervision of the Sec- SCOPE OF INSPECTION retary, such duties as the Secretary may require in the enforcement or ad- § 57.20 Inspection in accordance with ministration of the provisions of the methods prescribed or approved. Act, and this part. The Administrator Inspection of eggs shall be rendered may waive for a limited period any par- pursuant to these regulations and ticular provisions of the regulations to under such conditions and in accord- permit experimentation so that new ance with such methods as may be pre- procedures, equipment, and processing scribed or approved by the Adminis- techniques may be tested to facilitate trator. definite improvements and at the same time to maintain full compliance with [63 FR 69968, 69970, Dec. 17, 1998] the spirit and intent of the regulations. The Agricultural Marketing Service § 57.22 Basis of service. and its officers and employees shall not These regulations provide for inspec- be liable in damages through acts of tion services pursuant to the Egg Prod- commission or omission in the admin- ucts Inspection Act. Eggs and egg prod- istration of this part. ucts shall be inspected in accordance
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with such standards, methods, and in- EGGS AND EGG PRODUCTS NOT INTENDED structions as may be issued or ap- FOR HUMAN FOOD proved by the Administrator. Inspec- tion services shall be subject to super- § 57.45 Prohibition on eggs and egg vision at all times by the applicable products not intended for use as Federal-State supervisor, egg products human food. supervisor, Regional Director, and Na- (a) No person shall buy, sell, or trans- tional Supervisor. port or offer to buy or sell, or offer or receive for transportation in com- § 57.28 Other inspections. merce, any eggs or egg products which (a) Periodic inspections shall be are not intended for use as human food, made of: unless they are denatured or (1) Business premises, facilities, in- decharacterized, unless shipped under ventories, operations, transport vehi- seal as authorized in §§ 57.504(c) and cles, and records of egg handlers, and 57.720(a) and identified as required by the records of all persons engaged in the regulations in this part. the business of transporting, shipping, (b) No person shall import or export or receiving any eggs or egg products. shell eggs classified as loss, inedible, or In the case of shell egg packers pack- incubator rejects unless they are dena- ing eggs for the ultimate consumer, tured or decharacterized and identified such inspections shall be made a min- as required by the regulations in this imum of once each calendar quarter. part. Hatcheries are to be inspected a min- [63 FR 69968, 69970, Dec. 17, 1998] imum of once each fiscal year. (2) [Reserved] REFRIGERATION OF SHELL EGGS (b) Inspections shall be made of im- § 57.50 Temperature and labeling re- ported eggs as required in this part. quirements. [63 FR 69968, 69970, Dec. 17, 1998] (a) No shell egg handler shall possess any shell eggs that are packed into RELATION TO OTHER AUTHORITIES containers destined for the ultimate consumer unless they are stored and § 57.35 Eggs outside official plants. transported under refrigeration at an (a) For eggs which have moved or are ambient temperature of no greater moving in interstate or foreign com- than 45°F (7.2°C). merce, no State or local jurisdiction (1) (b) No shell egg handler shall possess may require the use of standards of any shell eggs that are packed into quality, condition, grade, or weight containers destined for the ultimate classes which are in addition to or dif- consumer unless they are labeled to in- ferent than the official standards or (2) dicate that refrigeration is required. other than those in noncontiguous (c) Any producer-packer with an an- areas of the United States may require nual egg production from a flock of labeling to show the State or other 3,000 or fewer hens is exempt from the geographical area of production or ori- temperature and labeling requirements gin. This shall not preclude a State of this section. from requiring the name, address, and license number of the person proc- EXEMPTIONS essing or packaging eggs to be shown on each container. § 57.100 Specific exemptions. (b) Any State or local jurisdiction The following are exempt to the ex- may exercise jurisdiction with respect tent prescribed as to the provisions for to eggs and egg products for the pur- control of restricted eggs in section pose of preventing the distribution for 8(a)(1) and (2) of the Act: Provided, That human food purposes of any such arti- as to paragraphs (c) through (f) of this cles which are outside of the official section, the exemptions do not apply to plant and are in violation of this part restricted eggs when prohibited by or any of said Federal Acts or any State or local law: And provided further, State or local law consistent there- That the sale of ‘‘hard-cooked shell with. eggs’’ or ‘‘peeled hard-cooked shell
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eggs’’ prepared from checks is subject and use of such eggs. Each such sale of to the conditions for exemption in ‘‘restricted eggs’’: Shall be limited to paragraphs (c), (d), and (f) of this sec- no more than 30 dozen eggs; tion: And provided further, That the (g) The processing in nonofficial conditions for exemption and provi- plants, including but not limited to sions of these regulations are met: bakeries, restaurants, and other food (a) The sale, transportation, posses- processors, without continuous inspec- sion, or use of eggs which contain no tion, of certain categories of food prod- more restricted eggs than are allowed ucts which contain eggs or egg prod- by the tolerances in the official stand- ucts as an ingredient, and the sale and ards for U.S. Consumer Grade B shell possession of such products: Provided, eggs; That such products are manufactured (b) [Reserved] (c) The sale at the site of production, from inspected egg products processed on a door-to-door retail route, or at an in accordance with this part or from established place of business away from eggs containing no more restricted the site of production, by a poultry eggs than are allowed in the official producer of eggs from his own flock’s standards for U.S. Consumer Grade B production directly to a household con- shell eggs; sumer exclusively for use by such con- (h) The purchase, sale, possession, or sumer and members of his household transportation of shell eggs containing and his nonpaying guests and employ- more restricted eggs than allowed in ees, and the transportation, possession, the tolerances for U.S. Consumer Grade and use of such eggs: Provided, That B shell eggs: Provided, That such eggs each such sale of restricted eggs shall are handled in accordance with §§ 57.200 be limited to no more than 30 dozen and 57.700 through 57.860 to assure that eggs; And provided further, (1) That eggs only eggs fit for human food are used sold directly to consumers at an estab- for such purpose. This exemption ap- lished place of business away from the plies to the following: site of production be moved directly (1) Egg producers, assemblers, whole- from the producer to such place of salers, and grading operations; business; (2) that such business away (2) Hatcheries; from the site of production be owned (3) Transporters; and managed by the producer; and (3) (4) Laboratories, pharmaceutical that such eggs which are sold on a door-to-door route or at an established companies; and place of business away from the site of (5) Processors of products not in- production shall contain no more loss tended for use as human food. and/or leakers than allowed in the offi- [63 FR 69968, 69971, Dec. 17, 1998] cial standards for U.S. Consumer Grade B shell eggs. § 57.105 Suspension or termination of (d) The sale of eggs by any producer exemptions. with an annual egg production from a (a) The Administrator may imme- flock of 3,000 hens or less and the diately suspend or terminate any ex- record requirements of § 57.200; emption under § 57.100(b) at any time (e) The processing and sale of egg with respect to any person, if the con- products by any poultry producer from eggs of his own flock’s production when ditions of exemption prescribed by this sold directly to a household consumer section are not being met. The Admin- exclusively for use by such consumer istrator may modify or revoke any reg- and members of his household and his ulation of this part, granting exemp- nonpaying guests and employees; tions whenever he determines such ac- (f) The sale of eggs by shell egg pack- tion appropriate to effectuate the pur- ers on the premises where the grading poses of the Act. station is located, directly to house- (b) Failure to comply with the condi- hold consumers for use by such con- tion of the exemptions contained in sumer and members of his household § 57.100 shall subject such person to the and his nonpaying guests and employ- penalties provided for in the Act and in ees, and the transportation, possession, this part.
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PERFORMANCE OF SERVICE § 57.116 Activities of inspectors. Inspectors at official plants shall § 57.110 Licensed inspectors. confine their activities to those duties (a) Any person who is a Federal or necessary in the rendering of inspec- State employee, or the employee of a tion service and such closely related local jurisdiction possessing proper activities as may be approved by the qualifications as determined by an ex- Administrator. amination for competency and who is to perform services pursuant to this § 57.118 Identification. part, may be licensed by the Secretary Inspectors shall have in their posses- as an inspector. sion at all times while on duty, and (b) Licenses issued by the Secretary present upon request, the means of are to be countersigned by the Admin- identification furnished by the Depart- istrator or by any other designated of- ment to such persons. ficial of the Service. (c) No person may be licensed to in- § 57.119 Political activity. spect any product in which he is finan- Inspectors are forbidden during the cially interested. period of their respective appoint- ments, or licenses, to take an active § 57.112 Suspension of license or au- part in political management or in po- thority; revocation. litical campaigns. Political activity in Pending final action by the Sec- city, county, State, or national elec- retary, any person authorized to coun- tions, whether primary or regular, or tersign a license to perform inspection in behalf of any party or candidate, ex- services may, whenever he deems such cept as authorized by law or regulation action necessary to assure that any in- of the Department, is prohibited. This spection service is properly performed, applies to all appointees, including but suspend any license to perform inspec- not being limited to temporary and co- tion services issued pursuant to this operative employees and employees on leave of absence with or without pay. part by giving notice of such suspen- Willful violation of this section or sion to the respective licensee, accom- § 57.120 will constitute grounds for dis- panied by a statement of the reasons missal in the case of appointees and therefor. Within 7 days after the re- revocation of licenses in the case of li- ceipt of the aforesaid notice and state- censees. ment of reasons by the licensee, he may file an appeal in writing, with the § 57.120 Financial interest of inspec- Secretary, supported by any argument tors. or evidence that he may wish to offer No inspector shall inspect any prod- as to why his license should not be sus- uct in which he is financially inter- pended or revoked. After the expiration ested. of the aforesaid 7-day period and con- sideration of such argument and evi- § 57.132 Access to plants. dence, the Secretary will take such ac- Access shall not be refused to any tion as he deems appropriate with re- representative of the Secretary to any spect to such suspension or revocation. plant, place of business, or transport When no appeal is filed within the pre- vehicle subject to inspection under the scribed 7 days, the license is revoked or provisions of this part upon presen- suspended. tation of proper credentials.
§ 57.114 Surrender of license. § 57.134 Accessibility of product. Upon termination of his services as (a) Each product for which inspection an inspector or whenever his license service is required shall be so placed as has been suspended or revoked, the li- to disclose fully its class, quality, censee shall surrender his license and quantity, and condition as the cir- other items of identification furnished cumstances may warrant. by the Department immediately to the (b) The perimeter of each cooler inspection service. room used to store shell eggs packed in
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containers destined for the ultimate ADMINISTRATIVE DETENTION consumer shall be made accessible in order for the Secretary’s representa- § 57.240 Detaining product. tives to determine the ambient tem- Whenever any eggs subject to the Act perature under which shell eggs are are found by any authorized represent- stored. ative of the Secretary upon any prem- ises, and there is reason to believe that RECORDS AND RELATED REQUIREMENTS they are or have been processed, FOR EGG HANDLERS AND RELATED IN- bought, sold, possessed, used, trans- DUSTRIES ported, or offered or received for sale or transportation in violation of the § 57.200 Records and related require- Act or the regulations in this part, or ments. that they are in any other way in vio- (a) Persons engaged in the business of lation of the Act, or whenever any re- transporting, shipping, or receiving stricted eggs capable of use as human any eggs in commerce, or holding such food are found by such a representative articles so received, and all egg han- in the possession of any person not au- dlers, including hatcheries, shall main- thorized to acquire such eggs under the tain records showing, for a period of 2 regulations in this part, such articles years, to the extent that they are con- may be detained by such representative cerned therewith, the receipt, delivery, for a period not to exceed 20 days, as sale, movement, and disposition of all more fully provided in section 19 of the eggs handled by them, and shall, upon Act. A detention tag or other similar the request of an authorized represent- device shall be used to identify de- ative of the Secretary, permit him, at tained product, and the custodian or reasonable times, to have access to and owner shall be given a written notice of to copy all such records. such detention. Only authorized rep- (b) Production records by categories resentatives of the Secretary shall affix or remove detention identifica- of eggs such as graded eggs, nest-run tion. The provisions of this section eggs, dirties, checks, leakers, loss, in- shall in no way derogate from author- edible, etc., bills of sale, inventories, ity for condemnation or seizure con- receipts, shipments, shippers, receiv- ferred by other provisions of the Act, ers, dates of shipment and receipt, car- the regulations in this part, or other rier names, etc., as determined by the laws. Administrator, shall be maintained by all shell egg handlers, except that, pro- [63 FR 69968, 69971, Dec. 17, 1998] ducers who ship all of their production as nest-run eggs without segregation APPEAL OF AN INSPECTION OR DECISION need only to maintain records indi- cating the amount of shell eggs § 57.300 Who may request an appeal inspection or review of an inspec- shipped, date of shipment, and the re- tor’s decision. ceivers’ name and address, need only to maintain records indicating the Any appeal inspection may be re- amount of eggs received, date received, quested by any interested party who is and the name and address of the ship- dissatisfied with the determination by per. an inspector of the class, quantity, or condition of any product, and a review [63 FR 69968, 69971, Dec. 17, 1998] may be requested by the operator of an official plant with respect to an inspec- § 57.220 Information and assistance to tor’s decision or on any other matter be furnished to inspectors. related to inspection in the official When inspection service is performed plant. at any plant, the plant operator shall furnish the inspector such information § 57.310 Where to file an appeal. and assistance as may be required for Any interested party who is not sat- the performance of inspection func- isfied with the determination of the tions, preparing certificates, reports, class, quantity, or condition of product and for other official duties. which was inspected other than in an
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official plant may request an appeal in- have been maintained under adequate spection by filing such request with the refrigeration when applicable. Regional Director in the region where (b) Laboratory analyses. The appeal the product is located or with the Chief sample shall consist of product taken of the Grading Branch. from the original sample containers plus an equal number of containers se- [63 FR 69971, Dec. 17, 1998] lected at random. When the original § 57.320 How to file an appeal. sample containers cannot be located, the appeal sample shall consist of prod- The request for an appeal inspection uct taken at random from double the or review of an inspector’s decision number of original sample containers. may be made orally or in writing. If (c) Condition inspection. The appeal made orally, written confirmation may sample shall consist of product taken be required. The applicant shall clearly from the original sample containers state the identity of the product, the plus an equal number of containers se- decision which is questioned, and the lected at random. A condition appeal reason(s) for requesting the appeal cannot be made unless all originally service. If such appeal request is based sampled containers are available. on the results stated on an official cer- tificate, the original and all copies of § 57.360 Appeal inspection certificates. the certificate available at the appeal Immediately after an appeal inspec- inspection site shall be provided to the tion is completed, an appeal certificate inspector assigned to make the appeal shall be issued to show that the origi- inspection. nal inspection was sustained or was not § 57.330 When an application for an sustained. Such certificate shall super- appeal grading or inspection may sede any previously issued certificate be refused. for the product involved and shall clearly identify the number and date of When it appears to the official with the superseded certificate. The whom an appeal request is filed that issuance of the appeal certificate may the reasons given in the request are be withheld until any previously issued frivolous or not substantial, or that certificate and all copies have been re- the condition of the product has under- turned when such action is deemed nec- gone a material change since the origi- essary to protect the interest of the nal grading or inspection, or that the Government. When the appeal inspec- original lot has changed in some man- tor assigns a different class to the lot ner, or the Act or the regulations in or determines that a net weight short- this part have not been complied with, age exists, the lot shall be retained the applicant’s request for the appeal pending correction of the labeling or inspection may be refused. In such approval of the product disposition by case, the applicant shall be promptly the National Supervisor. notified of the reason(s) for such re- fusal. § 57.370 Cost of appeals. § 57.340 Who shall perform the appeal. (a) There shall be no cost to the ap- pellant when the appeal inspection dis- The assignment of the inspector(s) closes a material error was made in the who will make the appeal inspection original determination. under § 57.310 shall be made by the Re- (b) The costs of an appeal shall be gional Director or the Chief of the borne by the appellant at an hourly Grading Branch, Poultry Division, Ag- rate of $27.36, including travel time and ricultural Marketing Service. expenses if the appeal was frivolous, in- [63 FR 69968, 69971, Dec. 17, 1998] cluding but not being limited to the following: The appeal inspection dis- § 57.350 Procedures for selecting ap- closes that no material error was made peal samples. in the original inspection, the condi- (a) Prohibition on movement of product. tion of the product has undergone a Products shall not have been moved material change since the original in- from the place where the inspection spection, the original lot has changed being appealed was performed and must in some manner, or the Act or these
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regulations have not been complied duction from a flock of 3,000 hens or with. less, who grade and pack eggs for the ultimate consumer, and hatcheries are IDENTIFYING AND MARKING PRODUCT required to register with the U.S. De- partment of Agriculture by furnishing § 57.410 Shell eggs required to be la- their name, place of business, and such beled. other information as is requested on All shell eggs packed into containers forms provided by or available from destined for the ultimate consumer the U.S. Department of Agriculture. shall be labeled to indicate that refrig- Completed forms shall be sent to the eration is required, e.g., ‘‘Keep Refrig- addressee indicated on the form. Per- erated,’’ or words of similar meaning. sons as those listed above who are es- [63 FR 69968, 69971, Dec. 17, 1998] tablishing a business will be required to register before they start oper- RETENTION ations. § 57.426 Retention. [40 FR 20059, May 8, 1975. Redesignated at 42 FR 32514, June 27, 1977, and further redesig- Retention tags or other devices and nated at 46 FR 63203, Dec. 31, 1981, as amend- methods as may be approved by the Ad- ed at 63 FR 45675, Aug. 27, 1998. Redesignated ministrator shall be used for the iden- at 63 FR 69970, Dec. 17, 1998] tification and control of products which are not in compliance with the INSPECTION AND DISPOSITION OF regulations or are held for further ex- RESTRICTED EGGS amination, and any equipment, uten- sils, rooms or compartments which are § 57.700 Prohibition on disposition of restricted eggs. found to be unclean or otherwise in violation of the regulations. No prod- (a) No person shall buy, sell, or trans- uct, equipment, utensil, room, or com- port, or offer to buy or sell, or offer or partment shall be released for use until receive for transportation in any busi- it has been made acceptable. Such ness in commerce any restricted eggs, identification shall not be removed by except as authorized in §§ 57.100 and anyone other than an inspector. 57.720. (b) No egg handler shall possess any PROCESSING REQUIREMENTS restricted eggs, except as authorized in §§ 57.100 and 57.720. § 57.504 General operating procedures. (c) No egg handler shall use any re- (a)–(b) [Reserved] stricted eggs in the preparation of (c) All loss and inedible eggs or egg human food, except as provided in products shall be placed in a container §§ 57.100 and 57.720. clearly labeled ‘‘inedible’’ and con- [36 FR 9814, May 28, 1971. Redesignated at 42 taining a sufficient amount of approved FR 32514, June 27, 1977, and further redesig- denaturant or decharacterant, such as nated at 46 FR 63203, Dec. 31, 1981, and at 63 FD&C brown, blue, black, or green col- FR 69970, Dec. 17, 1998] ors, meat and fish by-products, grain and milling by-products, or any other § 57.720 Disposition of restricted eggs. substance, as approved by the Adminis- (a) Eggs classified as checks, dirties, trator, that will accomplish the pur- incubator rejects, inedibles, leakers, or poses of this section. Shell eggs shall loss shall be disposed of by one of the be crushed and the substance shall be following methods at point and time of dispersed through the product in segregation: amounts sufficient to give the product (1) Checks and dirties shall be labeled a distinctive appearance or odor. in accordance with § 57.800 and shipped [63 FR 69971, Dec. 17, 1998] directly or indirectly to an official egg products plant for segregation and REGISTRATION OF SHELL EGG HANDLERS processing. Inedible and loss eggs shall not be intermingled in the same con- § 57.690 Persons required to register. tainer with checks and dirties. Shell egg handlers, except for pro- (2) By destruction in a manner ap- ducer-packers with an annual egg pro- proved by the Administrator, such as
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crushing and denaturing or (c) Records shall be maintained as decharacterizing in accordance with provided in § 57.200 to assure proper dis- § 57.504(c) and identifying the product position. as ‘‘Inedible Egg Product—Not To Be [36 FR 9814, May 28, 1971; 36 FR 10841, June 4, Used As Human Food.’’ 1971; 37 FR 6659, Apr. 1, 1972; 40 FR 20059, May (3) Processing for industrial use or 8, 1975. Redesignated at 42 FR 32514, June 27, for animal food. Such product shall be 1977, and further redesignated at 46 FR 63203, denatured or decharacterized in ac- Dec. 31, 1981, as amended at 47 FR 745, Jan. cordance with § 57.504(c) and identified 7, 1982; 60 FR 49170, Sept. 21, 1995. Redesig- nated at 63 FR 69970, Dec. 17, 1998] as provided in §§ 57.840 and 57.860, or handled in accordance with other pro- § 57.760 Inspection of egg handlers. cedures approved by the Adminis- trator. Notwithstanding the foregoing, Duly authorized representatives of product which was produced under offi- the Secretary shall make such periodic cial supervision and transported for in- inspections of egg handlers, their transport vehicles, and their records as dustrial use or animal food need not be the Secretary may require to ascertain denatured or decharacterized if it is if any of the provisions of the Act or shipped under Government seal and re- this part applicable to such egg han- ceived by an inspector or grader as de- dlers have been violated. Such rep- fined in this part. resentatives shall be afforded access to (4) By coloring the shells of loss and any place of business, plant, or trans- inedible eggs with a sufficient amount port vehicle subject to inspection of FD&C color to give a distinct ap- under the provisions of the Act. pearance, or applying a substance that will penetrate the shell and [63 FR 45675, Aug. 27, 1998. Redesignated at 63 FR 69970, Dec. 17, 1998] decharacterize the egg meat. Except that, lots of eggs containing significant IDENTIFICATION OF RESTRICTED EGGS OR percentages of blood spots or meat EGG PRODUCTS NOT INTENDED FOR spots, but no other types of loss or in- HUMAN CONSUMPTION edible eggs may be shipped directly to official egg products plants, provided § 57.800 Identification of restricted they are conspicuously labeled with eggs. the name and address of the shipper The shipping container of restricted and the wording ‘‘Spots—For Proc- eggs shall be determined to be satisfac- essing Only In Official Egg Products torily identified if such container bears Plants.’’ the packer’s name and address, the (5) Incubator rejects shall be broken quality of the eggs in the container or crushed and denatured or (e.g., dirties, checks, inedibles, or loss), decharacterized in accordance with or the statement ‘‘Restricted Eggs— § 57.504(c) and labeled as required in For Processing Only In An Official §§ 57.840 and 57.860. USDA Egg Products Plant,’’ for checks (b) Eggs which are packed for the ul- or dirties, or ‘‘Restricted Eggs—Not To timate consumer and which have been Be Used As Human Food,’’ for found to exceed the tolerance for re- inedibles, loss, and incubator rejects, stricted eggs permitted in the official or ‘‘Restricted Eggs—To Be Regraded’’ for graded eggs which contain more re- standards for U.S. Consumer Grade B stricted eggs than are allowed in the shall be identified as required in official standards for U.S. Consumer §§ 57.800 and 57.860 and shall be shipped Grade B shell eggs. The size of the let- directly or indirectly: ters of the identification wording shall (1) To an official egg products plant be as required in § 57.860. When eggs are for proper segregation and processing; packed in immediate containers, e.g., or cartons, sleeve packs, overwrapped 21⁄2- (2) Be regraded so that they comply or 3-dozen packs, etc., for sale to with the official standards; or household consumers under the exemp- (3) Used as other than human food. tions provided for in section 57.100 (c),
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or (f), they shall be deemed to be satis- § 57.905 Importation of restricted eggs factorily identified in accordance with or eggs containing more restricted the requirements of this part if such eggs than permitted in the official immediate containers bear the pack- standards for U.S. Consumer Grade er’s name and address and the quality B. of the eggs. Alternatively, a point of (a) No containers of restricted egg(s) sale sign may be displayed showing the other than checks or dirties shall be above information. imported into the United States. The shipping containers of such eggs shall § 57.801 Nest run or washed ungraded be identified with the name, address, eggs. and country of origin of the exporter, Nest run or washed ungraded eggs are and the date of pack and quality of the exempt from the labeling provisions in eggs (e.g., checks, or dirties) preceded § 57.800. However, when such eggs are by the word ‘‘Imported’’ or the state- packed and sold to consumers, they ment ‘‘Imported Restricted Eggs—For may not exceed the tolerance for re- Processing Only In An Official USDA stricted eggs permitted in the official Plant,’’ or ‘‘Restricted Eggs—Not To standards for U.S. Consumer Grade B Be Used As Human Food.’’ Such identi- shell eggs. fication shall be legible and con- [60 FR 49171, Sept. 21, 1995. Redesignated at spicuous. Alternatively, for properly 63 FR 69970, Dec. 17, 1998] sealed and certified shipments of shell eggs imported for breaking at an offi- § 57.840 Identification of inedible, un- cial egg products plant, the shipping wholesome, or adulterated egg containers need not be labeled, pro- products. vided that the shipment is segregated All inedible, unwholesome, or adul- and controlled upon arrival at the des- terated egg products shall be identified tination breaking plant. with the name and address of the proc- (b) Eggs which are imported for use essor, the words ‘‘Inedible Egg Prod- as human food and upon entry are ucts—Not To Be Used as Human Food.’’ found to contain more restricted eggs than permitted in the official stand- § 57.860 Identification wording. ards for U.S. Consumer Grade B, shall The letters of the identification be refused entry and returned to the wording shall be legible and con- importing country or be conspicuously spicuous. and legibly identified as ‘‘Imported Re- stricted Eggs’’ and be sent directly IMPORTS under official seal: (1) To a place where they may be regraded to comply with § 57.900 Requirements for importation the official U.S. standards for con- of restricted eggs into the United States. sumer grades; (2) to an official USDA egg products processing plant; or (3) to (a) Restricted eggs may be imported be used as other than human food. into the United States from any for- eign country only in accordance with § 57.915 Foreign inspection certifi- these regulations. The term United cation required. States means any State of the United (a) [Reserved] States, the Commonwealth of Puerto (b) Except as otherwise provided in Rico, the Virgin Islands of the United § 57.960, each consignment of shell eggs States, and the District of Columbia. shall be accompanied by a foreign in- The importation of any egg in viola- spection certificate, which, unless oth- tion of the regulations of this part is erwise approved by the Administrator prohibited. contains the following information: (b) All such imported articles shall (1) Country exporting product; upon entry into the United States be (2) City and date where issued; deemed and treated as domestic arti- (3) Quality or description of eggs; cles and be subject to the other provi- (4) Number of cases and total quan- sions of the Act, these regulations, and tity; other Federal or State requirements. (5) Identification marks on con- [63 FR 69968, 69971, Dec. 17, 1998] tainers;
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(6) Name and address of exporter; porter may be required to move the (7) Name and address of importer; product to the location of the nearest (8) A certification that the quality or inspector. description of the shell eggs, including (b) Inspectors may take samples, date of pack, is true and accurate; without cost to the United States, of (9) A certification that shell eggs any product offered for importation which have been packed into con- which is subject to analysis or quality tainers destined for the ultimate con- determination, except that samples sumer have, at all times after packing, shall not be taken of any products of- been stored and transported under re- fered for importation under § 57.960, un- frigeration at an ambient temperature less there is reason for suspecting the of no greater than 45 °F (7.2 °C); and presence therein of a substance in vio- (10) Name (including signature) and lation of that section. title of person authorized to issue in- [63 FR 69968, 69971, Dec. 17, 1998] spection certificates for shell eggs ex- ported to the United States. § 57.930 Imported eggs; retention in [63 FR 69968, 69971, Dec. 17, 1998] customs custody; delivery under bond; movement prior to inspec- § 57.920 Importer to make application tion; sealing; handling; facilities, for inspection of imported eggs. and assistance. Each person importing any eggs shall (a) No eggs required by this part to make application for inspection upon be inspected shall be released from cus- PY Form 222–Import Request, to the toms custody prior to required inspec- Chief, Poultry Grading Branch, Poul- tions, but such product may be deliv- try Division, Agricultural Marketing ered to the consignee, or his agent, Service, U.S. Department of Agri- prior to inspection if the consignee culture, Washington, DC 20250, or to shall furnish a bond, in the form pre- the Poultry Division, Poultry Grading scribed by the Secretary of the Treas- Branch office at the port where the ury, conditioned that the product shall product is to be offered for importa- be returned, if demanded, to the col- tion. Application shall be made as long lector of the port where the same is of- as possible prior to the arrival of each fered for clearance through customs. consignment of product, except in the (b) Notwithstanding paragraph (a) of case of product exempted from inspec- this section, no product required by tion by § 57.960. Each application shall this part to be inspected shall be state the approximate date of product moved prior to inspection from the arrival in the United States, the name port of arrival where first unloaded, of the ship or other carrier, the coun- and if arriving by water from the wharf try from which the product was where first unloaded at such port, to shipped, the destination, the quantity any place other than the place des- and class of product, whether fresh, ignated in accordance with this part as frozen, or dried, and the point of first the place where the same shall be in- arrival in the United States. spected; and no product shall be con- veyed in any manner other than in [63 FR 69968, 69971, Dec. 17, 1998] compliance with this part. (c) Means of conveyance or packages § 57.925 Inspection of imported eggs. in which any product is moved in ac- (a) Except as provided in § 57.960, eggs cordance with this part, prior to in- offered for importation from any for- spection, from the port or wharf where eign country shall be subject to inspec- first unloaded in the United States, tion in accordance with established in- shall be sealed with special import spection procedures, including the ex- seals of the U.S. Department of Agri- amination of the labeling information culture or otherwise identified as pro- on the containers, by an inspector be- vided herein, unless already sealed fore the product shall be admitted into with customs or consular seals in ac- the United States. Importers will be cordance with the customs regulations. advised of the point where inspection Such special seals shall be affixed by will be made, and in case of small ship- an inspector or, if there is no inspector ments (less than carload lots), the im- at such port, by a customs officer. In
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lieu of sealing packages, the carrier or § 57.935 Means of conveyance and importer may furnish and attach to equipment used in handling eggs to each package of product a warning no- be maintained in sanitary condi- tice on bright yellow paper, not less tion. than 5 x 8 inches in size, containing the Compartments of boats, railroad following legend in black type of a con- cars, and other means of conveyance spicuous size: transporting any product to the United States, and all chutes, platforms, (Name of Truck Line or Carrier) racks, tables, tools, utensils, and all NOTICE other devices used in moving and han- This package of lllll must be deliv- dling such product offered for importa- ered intact to an inspector of the Poultry Di- tion, shall be maintained in a sanitary vision, U.S. Department of Agriculture. condition.
WARNING § 57.945 Foreign eggs offered for im- Failure to comply with these instructions portation; reporting of findings to will result in penalty action being taken customs; handling of products re- against the holder of the customs entry fused entry. bond. (a) Inspectors shall report their find- If the product is found to be acceptable ings to the collector of customs at the upon inspection, the product may be released port where products are offered for to the consignee, or his agent, and this warn- entry, and shall request the collector ing notice defaced. to refuse entry to eggs which are (d) No person shall affix, break, alter, marked or designated ‘‘U.S. Refused deface, mutilate, remove, or destroy Entry’’ or otherwise are not in compli- any special import seal of the U.S. De- ance with the regulations in this part. partment of Agriculture, except cus- Unless such products are exported by toms officers or inspectors, or as pro- the consignee within a time specified vided in paragraph (f) of this section. by the collector of customs (usually 30 (e) No product shall be removed from days), the consignee shall cause the de- any means of conveyance or package struction of such products for human sealed with a special import seal of the food purposes under the supervision of U.S. Department of Agriculture, except an inspector. If products are destroyed under the supervision of an inspector for human food purposes under the su- or a customs officer, or as provided in pervision of an inspector, he shall give paragraph (f) of this section. prompt notice thereof to the District (f) In case of a wreck or similar ex- Director of Customs. traordinary emergency, the special im- (b) Consignees shall, at their own ex- port seal of the U.S. Department of Ag- pense, return immediately to the col- riculture on a car, truck, or other lector of customs, in means of convey- means of conveyance may be broken by ance or packages sealed by the U.S. De- the carrier and, if necessary, the arti- partment of Agriculture, any eggs re- cles may be reloaded into another ceived by them under this part which means of conveyance for transpor- in any respect do not comply with this tation to destination. In all such cases, part. the carrier shall immediately report (c) Except as provided in § 57.930(a), the facts by telegraph to the Chief of no person shall remove or cause to be the Grading Branch. removed from any place designated as (g) The consignee or his agent shall the place of inspection, any eggs which provide such facilities and assistance the regulations require to be marked in as the inspector may require for the in- any way, unless the same has been spection and handling and marking of clearly and legibly marked in compli- products offered for importation. ance with this part. [63 FR 69968, 69971, Dec. 17, 1998] [63 FR 69968, 69971, Dec. 17, 1998]
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§ 57.950 Labeling of containers of eggs plant, the shipping containers need not for importation. be labeled, provided that the shipment (a) Immediate containers of product is segregated and controlled upon ar- offered for importation shall bear a rival at the destination breaking plant. label, printed in English, showing: (d) In the case of products which are (1) The name of product; not in compliance solely because of (2) The name of the country of origin misbranding, such products may be of the product, and for consumer pack- brought into compliance with the regu- aged products, preceded by the words lations only under the supervision of ‘‘Product of,’’ which statement shall an authorized representative of the Ad- appear immediately under the name of ministrator. the product; [63 FR 69968, 69971, Dec. 17, 1998] (3) The quality or description of shell eggs, including date of pack; § 57.960 Small importations for con- (4) For shell eggs, the words, ‘‘Keep signee’s personal use, display, or Refrigerated,’’ or words of similar laboratory analysis. meaning; Any eggs which are offered for impor- (5) [Reserved] tation, exclusively for the consignee’s (6) The name and place of business of personal use, display, or laboratory manufacturer, packer, or distributor, analysis, and not for sale or distribu- qualified by a phrase which reveals the tion; which is sound, healthful, whole- connection that such person has with some, and fit for human food; and the product; which is not adulterated and does not (7) An accurate statement of the contain any substance not permitted quantity; by the Act or regulations, may be ad- (b) For properly sealed and certified mitted into the United States without shipments of shell eggs imported for a foreign inspection certificate. Such breaking at an official egg products product is not required to be inspected plant, the immediate containers need upon arrival in the United States and not be labeled, provided that the ship- may be shipped to the consignee with- ment is segregated and controlled upon out further restriction under this part: arrival at the destination breaking Provided, That the Department may, plant. with respect to any specific importa- (c) The labels shall not be false or tion, require that the consignee certify misleading in any respect. that such product is exclusively for the [63 FR 69968, 69971, Dec. 17, 1998] consignee’s personal use, display, or laboratory analysis and not for sale or § 57.955 Labeling of shipping con- distribution. The amount of such prod- tainers of eggs for importation. uct imported shall not exceed 30-dozen (a) Shipping containers of foreign shell eggs, unless otherwise authorized product which are shipped to the by the Administrator. United States shall bear in a promi- [63 FR 69968, 69971, Dec. 17, 1998] nent and legible manner: (1) The common or usual name of the § 57.965 Returned U.S. inspected and product; marked products; not importations. (2) The name of the country of origin; Products which have been inspected (3)–(4) [Reserved] by the United States Department of (5) The quality or description of the Agriculture and so marked, and which eggs, except as required in § 57.905; are returned from foreign countries are (6) The words ‘‘Keep refrigerated’’ or not importations within the meaning words of similar meaning. of this part. Such returned shipments (b) Labeling on shipping containers shall be reported to the Administrator examined at the time of inspection in by letter. the United States, if found to be false or misleading, shall be cause for the § 57.970 Charges for storage, cartage, product to be refused entry. and labor with respect to products (c) For properly sealed and certified imported contrary to the Act. shipments of shell eggs imported for All charges for storage, cartage, and breaking at an official egg products labor with respect to any product
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which is imported contrary to this part mal administrative proceeding pursu- shall be paid by the owner or con- ant to the Uniform Rules of Practice, signee, and in default of such payment Subpart H, Part 1, Title 7, Code of Fed- shall constitute a lien against such eral Regulations. product and any other product there- after imported under the Act by or for PART 58—GRADING AND INSPEC- such owner or consignee. TION, GENERAL SPECIFICATIONS FOR APPROVED PLANTS AND Subpart B—Rules of Practice Gov- STANDARDS FOR GRADES OF erning Proceedings Under the DAIRY PRODUCTS1 Egg Products Inspection Act Subpart A—Regulations Governing the In- SOURCE: 64 FR 40738, July 28, 1999, unless spection and Grading Services of otherwise noted. Manufactured or Processed Dairy Products SCOPE AND APPLICABILITY OF RULES OF PRACTICE DEFINITIONS § 57.1000 Administrative proceedings. Sec. 58.1 Meaning of words. (a) The Uniform Rules of Practice for 58.2 Designation of official certificates, the Department of Agriculture promul- memoranda, marks, identifications, and gated in subpart H of part 1, subtitle A, devices for purpose of the Agricultural title 7, Code of Federal Regulations, Marketing Act. are the Rules of Practice applicable to ADMINISTRATION adjudicating administrative pro- ceedings under section 12(c) of the Egg 58.3 Authority. Products Inspection Act (21 U.S.C. INSPECTION OR GRADING SERVICE 1041). (b) In addition to the proceedings set 58.4 Basis of service. forth in paragraph (a) of this section, 58.5 Where service is offered. the Administrator, in his discretion, at 58.6 Supervision of service. 58.7 Who may obtain service. any time prior to the issuance of a 58.8 How to make application. complaint seeking a civil penalty 58.9 Form of application. under the Act may enter into a stipula- 58.10 Filing of application. tion with any person, in accordance 58.11 Approval of application. with the following prescribed condi- 58.12 When application may be rejected. tions: 58.13 When application may be withdrawn. (1) The Administrator gives notice of 58.14 Authority of applicant. an apparent violation of the Act or the 58.15 Accessibility and condition of product. regulations issued thereunder by such 58.16 Disposition of samples. 58.17 Order of service. person and affords such person an op- 58.18 Inspection or grading certificates, portunity for a hearing regarding the memoranda, or reports. matter as provided by the Act; 58.19 Issuance of inspection or grading cer- (2) Such person expressly waives tificates. hearing and agrees to a specified order 58.20 Disposition of inspection or grading including an agreement to pay a speci- certificates or reports. fied civil penalty within a designated 58.21 Advance information. time; and APPEAL INSPECTION OR GRADING AND (3) The Administrator agrees to ac- REINSTATEMENT OF REGRADING cept the specified civil penalty in set- tlement of the particular matter in- 58.22 When appeal inspection or grading may be requested. volved if it is paid within the des- 58.23 How to obtain appeal inspection or ignated time. grading. (4) If the specified penalty is not paid 58.24 Record of filing time. within the time designated in such 58.25 When an application for appeal inspec- stipulation, the amount of the stipu- tion or grading may be refused. lated penalty shall not be relevant in 1 Compliance with these standards does not any respect to the penalty that may be excuse failure to comply with the provisions assessed after the institution of a for- of the Federal Food, Drug and Cosmetic Act.
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58.26 When an application for an appeal in- Subpart B—General Specifications for spection or grading may be withdrawn. Dairy Plants Approved for USDA In- 58.27 Order in which appeal inspections or spection and Grading Service gradings are performed. 58.28 Who shall make appeal inspections or DEFINITIONS gradings. 58.29 Appeal inspection or grading certifi- 58.100 OMB control numbers assigned pursu- cate or report. ant to the Paperwork Reduction Act. 58.30 Application for reinspection or regrad- 58.101 Meaning of words. ing. 58.31 Reinspection or regrading certificate PURPOSE or report. 58.122 Approved plants under USDA inspec- 58.32 Superseded certificates or reports. tion and grading service.
LICENSING OF INSPECTORS OR GRADERS APPROVED PLANTS 58.33 Who may be licensed. 58.123 Survey and approval. 58.34 Suspension or revocation of license. 58.124 Denial or suspension of plant ap- 58.35 Surrender of license. proval. 58.36 Identification. 58.37 Financial interest of licensees. PREMISES, BUILDINGS, FACILITIES, EQUIPMENT AND UTENSILS FEES AND CHARGES 58.125 Premises. 58.38 Payment of fees and charges. 58.39 Fees for holiday or other 58.126 Buildings. nonworktime. 58.127 Facilities. 58.40 Fees for appeal inspection or grading. 58.128 Equipment and utensils. 58.41 Fees for additional copies of certifi- PERSONNEL, CLEANLINESS AND HEALTH cates. 58.42 Travel expenses and other charges. 58.129 Cleanliness. 58.43 Fees for inspection, grading, and sam- 58.130 Health. pling. 58.45 Fees for continuous resident services. PROTECTION AND TRANSPORT OF RAW MILK 58.46 Fees for service performed under coop- AND CREAM erative agreement. 58.131 Equipment and facilities. MARKING, BRANDING, AND IDENTIFYING QUALITY SPECIFICATIONS FOR RAW MILK PRODUCT 58.132 Basis for classification. 58.49 Authority to use official identifica- tion. 58.133 Methods for quality and wholesome- 58.50 Approval and form of official identi- ness determination. fication. 58.134 Sediment content. 58.51 Information required on official iden- 58.135 Bacterial estimate. tification. 58.136 Rejected milk. 58.52 Time limit for packaging inspected or 58.137 Excluded milk. graded products with official identifica- 58.138 Quality testing of milk from new pro- tion. ducers. 58.139 Record of tests. PREREQUISITES TO PACKAGING PRODUCTS WITH 58.140 Field service. OFFICIAL IDENTIFICATION 58.141 Alternate quality control program.
58.53 Supervisor of packaging required. OPERATIONS AND OPERATING PROCEDURES 58.54 Packing and packaging room and equipment. 58.142 Product quality and stability. 58.55 Facilities for keeping quality samples. 58.143 Raw product storage. 58.56 Incubation of product samples. 58.144 Pasteurization or ultra-pasteuriza- 58.57 Product not eligible for packaging tion. with official identification. 58.145 Composition and wholesomeness. 58.146 Cleaning and sanitizing treatment. VIOLATIONS 58.147 Insect and rodent control program. 58.58 Debarment of service. 58.148 Plant records. 58.149 Alternate quality control programs MISCELLANEOUS for dairy products. 58.61 Political activity. PACKAGING AND GENERAL IDENTIFICATION 58.62 Report of violations. 58.63 Other applicable regulations. 58.150 Containers. 58.64 OMB control numbers assigned pursu- 58.151 Packaging and repackaging. ant to the Paperwork Reduction Act. 58.152 General identification.
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STORAGE OF FINISHED PRODUCT 58.243 Checking quality. 58.244 Number of samples. 58.153 Dry storage. 58.154 Refrigerated storage. 58.245 Method of official sample analysis. 58.246 Cleaning of dryers, collectors, con- INSPECTION, GRADING AND OFFICIAL veyors, ducts, sifters and storage bins. IDENTIFICATION 58.247 Insect and rodent control program.
58.155 Grading. REQUIREMENTS FOR FINISHED PRODUCTS 58.156 Inspection. BEARING USDA OFFICIAL IDENTIFICATION 58.157 Inspection or grading certificates. 58.158 Official identification. 58.248 Nonfat dry milk. 58.249 Instant nonfat dry milk. EXPLANATION OF TERMS 58.250 Dry whole milk. 58.251 Dry buttermilk and dry buttermilk 58.159 Terms. product. SUPPLEMENTAL SPECIFICATIONS FOR PLANTS SUPPLEMENTAL SPECIFICATIONS FOR PLANTS MANUFACTURING, PROCESSING AND PACK- MANUFACTURING, PROCESSING AND PACK- AGING NONFAT DRY MILK, INSTANT NONFAT AGING BUTTER AND RELATED PRODUCTS DRY MILK, DRY WHOLE MILK, AND DRY BUT- TERMILK DEFINITIONS DEFINITIONS 58.305 Meaning of words.
58.205 Meaning of words. ROOMS AND COMPARTMENTS ROOMS AND COMPARTMENTS 58.311 Coolers and freezers. 58.210 Dry storage of product. 58.312 Churn rooms. 58.211 Packaging room for bulk products. 58.313 Print and bulk packaging rooms. 58.212 Hopper or dump room. EQUIPMENT AND UTENSILS 58.213 Repackaging room. 58.314 General construction, repair and in- EQUIPMENT AND UTENSILS stallation. 58.214 General construction, repair and in- 58.315 Continuous churns. stallation. 58.316 Conventional churns. 58.215 Pre-heaters. 58.317 Bulk butter trucks, boats, 58.216 Hotwells. texturizers, and packers. 58.217 Evaporators and/or vacuum pans. 58.318 Butter, frozen or plastic cream melt- 58.218 Surge tanks. ing machines. 58.219 High pressure pumps and lines. 58.319 Printing equipment. 58.220 Drying systems. 58.320 Brine tanks. 58.221 Collectors and conveyors. 58.321 Cream storage tanks. 58.222 Dry dairy product cooling equipment. QUALITY SPECIFICATIONS FOR RAW MATERIAL 58.223 Special treatment equipment. 58.224 Sifters. 58.322 Cream. 58.225 Clothing and shoe covers. 58.323 [Reserved] 58.226 Portable and stationary bulk bins. 58.324 Butteroil. 58.227 Sampling device. 58.325 Anhydrous milkfat. 58.228 Dump hoppers, screens, mixers and 58.326 Plastic cream. conveyors. 58.327 Frozen cream. 58.229 Filler and packaging equipment. 58.328 Salt. 58.230 Heavy duty vacuum cleaners. 58.329 Color. 58.330 Butter starter cultures. QUALITY SPECIFICATIONS FOR RAW MATERIALS 58.331 Starter distillate. 58.231 General. 58.232 Milk. OPERATIONS AND OPERATING PROCEDURES 58.233 Skim milk. 58.332 Segregation of raw material. 58.234 Buttermilk. 58.334 Pasteurization. 58.235 Modified dry milk products. 58.335 Quality control tests. 58.336 Frequency of sampling for quality OPERATIONS AND OPERATING PROCEDURES control of cream, butter and related 58.236 Pasteurization and heat treatment. products. 58.237 Condensed surge supply. 58.337 Official test methods. 58.238 Condensed storage tanks. 58.338 Composition and wholesomeness. 58.239 Drying. 58.339 Containers. 58.240 Cooling dry products. 58.340 Printing and packaging. 58.241 Packaging, repackaging and storage. 58.341 Repackaging. 58.242 Product adulteration. 58.342 General identification.
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58.343 Storage of finished product in cool- 58.443 Whey handling. ers. 58.444 Packaging and repackaging. 58.344 Storage of finished product in freezer. 58.445 General identification.
REQUIREMENTS FOR FINISHED PRODUCTS REQUIREMENTS FOR FINISHED PRODUCTS BEARING USDA OFFICIAL IDENTIFICATION BEARING USDA OFFICIAL IDENTIFICATION 58.345 Butter. 58.446 Quality requirements. 58.346 Whipped butter. 58.347 Butteroil or anhydrous milkfat. SUPPLEMENTAL SPECIFICATIONS FOR PLANTS 58.348 Plastic cream. MANUFACTURING AND PACKAGING COTTAGE 58.349 Frozen cream. CHEESE
SUPPLEMENTAL SPECIFICATIONS FOR PLANTS DEFINITIONS MANUFACTURING AND PACKAGING CHEESE 58.505 Meaning of words.
DEFINITIONS ROOMS AND COMPARTMENTS 58.405 Meaning of words. 58.510 Rooms and compartments.
ROOMS AND COMPARTMENTS EQUIPMENT AND UTENSILS 58.406 Starter facility. 58.511 General construction, repair and in- 58.407 Make room. stallation. 58.408 Brine room. 58.512 Cheese vats or tanks. 58.409 Drying room. 58.513 Agitators. 58.410 Paraffining room. 58.514 Container fillers. 58.411 Rindless cheese wrapping area. 58.515 Mixers. 58.412 Coolers or curing rooms. 58.516 Starter vats. 58.413 Cutting and packaging rooms. QUALITY SPECIFICATIONS FOR RAW MATERIAL EQUIPMENT AND UTENSILS 58.517 General. 58.414 General construction, repair and in- 58.518 Milk. stallation. 58.519 Dairy products. 58.415 Starter vats. 58.520 Nondairy ingredients. 58.416 Cheese vats, tanks and drain tables. 58.417 Mechanical agitators. OPERATIONS AND OPERATING PROCEDURES 58.418 Automatic cheese making equipment. 58.419 Curd mill and miscellaneous equip- 58.521 Pasteurization and product flow. ment. 58.522 Reconstituting nonfat dry milk. 58.420 Hoops, forms and followers. 58.523 Laboratory and quality control tests. 58.421 Press. 58.524 Packaging and general identification. 58.422 Brine tank. 58.525 Storage of finished product. 58.423 Cheese vacuumizing chamber. REQUIREMENTS FOR COTTAGE CHEESE BEARING 58.424 Monorail. USDA OFFICIAL IDENTIFICATION 58.425 Conveyor for moving and draining block or barrel cheese. 58.526 Official identification. 58.426 Rindless cheese wrapping equipment. 58.527 Physical requirements. 58.427 Paraffin tanks. 58.528 Microbiological requirements. 58.428 Specialty equipment. 58.529 Chemical requirements. 58.429 Washing machine. 58.530 Keeping quality requirements.
QUALITY SPECIFICATIONS FOR RAW MATERIAL SUPPLEMENTAL SPECIFICATIONS FOR PLANTS MANUFACTURING, PROCESSING, AND PACK- 58.430 Milk. AGING FROZEN DESSERTS 58.431 Hydrogen peroxide. 58.432 Catalase. DEFINITIONS 58.433 Cheese cultures. 58.434 Calcium chloride. 58.605 Meaning of words. 58.435 Color. ROOMS AND COMPARTMENTS 58.436 Rennet, pepsin, or other milk clot- ting enzymes and flavor enzymes. 58.619 Mix processing room. 58.437 Salt. 58.620 Freezing and packaging rooms. 58.621 Freezing tunnels. OPERATIONS AND OPERATING PROCEDURES 58.622 Hardening and storage rooms. 58.438 Cheese from pasteurized milk. EQUIPMENT AND UTENSILS 58.439 Cheese from unpasteurized milk. 58.440 Make schedule. 58.623 Homogenizer. 58.441 Records. 58.624 Freezers. 58.442 Laboratory and quality control tests. 58.625 Fruit or syrup feeders.
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58.626 Packaging equipment. 58.716 Nonfat dry milk. 58.717 Whey. QUALITY SPECIFICATIONS FOR RAW MATERIAL 58.718 Flavor ingredients. 58.627 Milk and dairy products. 58.719 Coloring. 58.628 Sweetening agents. 58.720 Acidifying agents. 58.629 Flavoring agents. 58.721 Salt. 58.630 Stabilizers. 58.722 Emulsifying agents. 58.631 Emulsifiers. 58.632 Acid. OPERATIONS AND OPERATING PROCEDURES 58.633 Color. 58.723 Basis for selecting cheese for proc- OPERATIONS AND OPERATING PROCEDURES essing. 58.634 Assembling and combining mix ingre- 58.724 Blending. dients. 58.725 Trimming and cleaning. 58.635 Pasteurization of the mix. 58.726 Cutting and grinding. 58.636 Homogenization. 58.727 Adding optional ingredients. 58.637 Cooling the mix. 58.728 Cooking the batch. 58.638 Freezing the mix. 58.729 Forming containers. 58.639 Addition of flavor. 58.730 Filling containers. 58.640 Packaging. 58.731 Closing and sealing containers. 58.641 Hardening and storage. 58.732 Cooling the packaged cheese. 58.642 Quality control tests. 58.733 Quality control tests. 58.643 Frequency of sampling. 58.644 Test methods. REQUIREMENTS FOR PROCESSED CHEESE PROD- 58.645 General identification. UCTS BEARING USDA OFFICIAL IDENTIFICA- TION REQUIREMENTS FOR FINISHED PRODUCTS BEARING USDA OFFICIAL IDENTIFICATION 58.734 Official identification. 58.646 Official identification. 58.735 Quality specifications for raw mate- 58.647 Composition requirements for ice rials. cream. QUALITY SPECIFICATIONS FOR FINISHED 58.648 Microbiological requirements for ice PRODUCTS cream. 58.649 Physical requirements for ice cream. 58.736 Pasteurized process cheese. 58.650 Requirements for frozen custard. 58.737 Pasteurized process cheese food. 58.651 Requirements for ice milk. 58.738 Pasteurized process cheese spread and 58.652 Composition requirements for sher- related products. bet. 58.653 Microbiological requirements for SUPPLEMENTAL SPECIFICATIONS FOR PLANTS sherbet. MANUFACTURING, PROCESSING, AND PACK- 58.654 Physical requirements for sherbet. AGING WHEY, WHEY PRODUCTS AND LACTOSE
SUPPLEMENTAL SPECIFICATIONS FOR PLANTS DEFINITIONS MANUFACTURING, PROCESSING AND PACK- AGING PASTEURIZED PROCESS CHEESE AND 58.805 Meaning of words. RELATED PRODUCTS ROOMS AND COMPARTMENTS DEFINITIONS 58.806 General. 58.705 Meaning of words. EQUIPMENT AND UTENSILS EQUIPMENT AND UTENSILS 58.807 General construction, repair and in- 58.706 General construction, repair and in- stallation. stallation. 58.707 Conveyors. QUALITY SPECIFICATIONS FOR RAW MATERIALS 58.708 Grinders or shredders. 58.808 Whey. 58.709 Cookers. 58.710 Fillers. OPERATIONS AND OPERATING PROCEDURES
QUALITY SPECIFICATIONS FOR RAW MATERIAL 58.809 Pasteurization. 58.810 Temperature requirements. 58.711 Cheddar, colby, washed or soaked 58.811 General. curd, granular or stirred curd cheese. 58.712 Swiss. 58.812 Methods of official sample analysis. 58.713 Gruyere. REQUIREMENTS FOR FINISHED PRODUCTS 58.714 Cream cheese, Neufchatel cheese. BEARING USDA OFFICIAL IDENTIFICATION 58.715 Cream, plastic cream and anhydrous milkfat. 58.813 Dry whey.
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SUPPLEMENTAL SPECIFICATIONS FOR PLANTS NOTE: Compliance with these standards MANUFACTURING, PROCESSING AND PACK- does not excuse failure to comply with the AGING EVAPORATED AND CONDENSED MILK provisions of the Federal Food, Drug, and OR ULTRA-PASTEURIZED PRODUCTS Cosmetic Act.
DEFINITIONS Subpart A—Regulations Gov- 58.905 Meaning of words. erning the Inspection and EQUIPMENT AND UTENSILS Grading Services of Manufac- 58.912 General construction, repair and in- tured or Processed Dairy stallation. Products 58.913 Evaporators and vacuum pans. 58.914 Fillers. SOURCE: 37 FR 22363, Oct. 19, 1972, unless 58.915 Batch or continuous in-container otherwise noted. Redesignated at 42 FR 32514, thermal processing equipment. June 27, 1977, and further redesignated at 46 58.916 Homogenizer. FR 63203, Dec. 31, 1981. OPERATIONS AND OPERATING PROCEDURES DEFINITIONS 58.917 General. 58.918 Standardization. § 58.1 Meaning of words. 58.919 Pre-heat, pasteurization. 58.920 Homogenization. For the purpose of the regulations in 58.921 Concentration. this subpart, words in the singular 58.922 Thermal processing. form shall be deemed to import the 58.923 Filling containers. plural and vice versa, as the case may 58.924 Aseptic filling. demand. Unless the context otherwise 58.925 Sweetened condensed. requires, the following terms shall 58.926 Heat stability. have the following meaning: 58.927 Storage. Act means the applicable provisions 58.928 Quality control tests. of the Agricultural Marketing Act of 58.929 Frequency of sampling for quality control. 1946 (60 Stat. 1087, as amended; 7 U.S.C. 58.930 Official test methods. 1621–1627) or any other act of Congress 58.931 General identification. conferring like authority. Administrator means the Adminis- QUALITY SPECIFICATIONS FOR RAW MATERIALS trator of the Agricultural Marketing 58.932 Milk. Service or any other officer or em- 58.933 Stabilizers. ployee of the Agricultural Marketing 58.934 Sugars. Service to whom authority has here- 58.935 Chocolate and cocoa. tofore been delegated, or to whom au-
REQUIREMENTS FOR FINISHED PRODUCTS thority may hereafter be delegated, to BEARING USDA OFFICIAL IDENTIFICATION act in his stead. Agricultural Marketing Service or AMS 58.936 Milk. means the Agricultural Marketing 58.937 Physical requirements for evaporated milk. Service of the Department. 58.938 Physical requirements and micro- Applicant means any interested party biological limits for sweetened condensed who has applied for inspection or grad- milk. ing service. Approved laboratory means a labora- SUBPARTS C–V[RESERVED] tory in which the facilities and equip- Subpart W—United States Department of ment used for official testing have been Agriculture Standard for Ice Cream adequate to perform the necessary offi- cial tests in accordance with this part. 58.2825 United States Standard for ice Approved plant means one or more ad- cream. jacent buildings, or parts thereof, com- 58.2826 General identification. prising a single plant at one location in 58.2827 Official identification. which the facilities and methods of op- AUTHORITY: 7 U.S.C. 1621—1627. eration therein have been surveyed and
SOURCE: 23 FR 9410, Dec. 5, 1958, unless oth- approved by the Administrator as suit- erwise noted. Redesignated at 42 FR 32514, able and adequate for inspection or June 27, 1977, and further redesignated at 46 grading service in accordance with this FR 63203, Dec. 31, 1981. part.
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Area Supervisor means any employee product or packaging material by of the Branch in charge of dairy inspec- means of official identification; (e) re- tion or grading service in a designated grading or appeal grading of a pre- geographical area. viously graded product; (f) inspecting Branch means the Dairy Inspection dairy plant facilities, equipment, and Branch of the Poultry and Dairy Qual- operations; such as, processing, manu- ity Division. facturing, packaging, repackaging, and Chief means the Chief of the Branch, quality control; (g) supervision of or any officer or employee of the packaging inspected or graded product; Branch to whom authority has been (h) reinspection or appeal inspection; heretofore delegated, or to whom au- and (i) issuing an inspection or grading thority may hereafter be delegated, to certificate or sampling, inspection, or act in his stead. other report related to any of the fore- Class means any subdivision of a going. product based on essential physical Inspector or grader means any Federal characteristics that differentiate be- tween major groups of the same kind or State employee to whom a license or method of processing. has been issued by the Administrator Condition of container means the de- to perform one or more types of inspec- gree of acceptability of the container tion or grading services. with respect to freedom from defects Inspection or grading office means the which affect its serviceability, includ- office of any inspector or grader. ing appearance as well as usability, of Interested party means any person fi- the container for its intended purpose. nancially interested in a transaction Condition of product or condition is an involving any inspection or grading expression of the extent to which a service. product is free from defects which af- Licensed plant employee means an em- fect its usability, including but not ployee of an approved plant to whom a limited to, the state of preservation, license is issued by the Administrator cleanliness, soundness, wholesomeness, to supervise packaging of officially in- or fitness for human food. spected or graded product, perform lab- Continuous resident service or resident oratory tests, or perform other duties service is inspection or grading service as assigned by the Administrator. A li- performed at a dairy manufacturing censed plant employee is not author- plant or grading station by an inspec- ized to issue any inspection or grading tor or grader assigned to the plant or certificate. station on a continuous, year-round, Product means butter, cheese (wheth- resident basis. er natural or processed), milk, cream, or means the U.S. Department USDA milk products (whether dried, frozen, Department of Agriculture. evaporated, stabilized, or condensed), Director means the Director of the ice cream, dry whey, dry buttermilk, Poultry and Dairy Quality Division, or and any other food product, which is any other officer or employee of the Di- prepared or manufactured in whole or vision to whom authority has here- tofore been delegated or to whom au- in part from any of the aforesaid prod- thority may hereafter be delegated, to ucts, as the Administrator may here- act in his stead. after designate. Division means the Poultry and Dairy Person means any individual, part- Quality Division of the Agricultural nership, association, business, trust, Marketing Service. corporation, or any organized group of Inspection or grading service or service persons, whether incorporated or not. means in accordance with this part, Plant survey means an appraisal of the act of (a) drawing samples of any the plant to determine extent to which product; (b) determining the class, facilities, equipment, method of oper- grade, quality, composition, size, quan- ation, and raw material being received tity, or condition of any product by ex- are in accordance with the provisions amining each unit or representative of this part. The survey shall be used samples; (c) determining condition of to determine suitability of the plant product containers; (d) identifying any for inspection or grading service.
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Quality means the inherent prop- authorized person in the process of in- erties of any product which determine specting, grading, determining compli- its relative degree of excellence. ance, or sampling pursuant to the regu- Regulations means the provisions of lations in this subpart, any processing this subpart. or plant-operation report made by an Sampling report means a statement authorized person in connection with issued by an inspector or grader identi- inspecting, grading, determining com- fying samples taken by him for inspec- pliance, or sampling under the regula- tion or grading service. tions in this subpart, and any report Supervisor of packaging means an em- made by an authorized person of serv- ployee of the Department or other per- ices performed pursuant to the regula- son licensed by the Administrator to tions in this subpart. supervise the packaging and official (c) Official identification or other offi- identification of product or any re- cial marks means any form of identi- packaging of bulk product. fication or mark (including, but not (60 Stat. 1087, 7 U.S.C. 1621 et seq.; 84 Stat. limited to, those in §§ 58.49 through 1620, 21 U.S.C. 1031 et seq.) 58.51) approved by the Administrator [37 FR 22363, Oct. 19, 1972, as amended at 38 and authorized to be affixed to any FR 4381, Feb. 14, 1973. Redesignated at 42 FR product, or affixed to or printed on the 32514, June 27, 1977, as amended at 43 FR packaging material of any product cer- 60138, Dec. 26, 1978. Redesignated at 46 FR tifying the inspection, class, grade, 63203, Dec. 31, 1981, as amended at 54 FR 15167, Apr. 17, 1989] quality, size, quantity, or condition of the products (including the compliance § 58.2 Designation of official certifi- of products with applicable specifica- cates, memoranda, marks, identi- tions) or to maintain the identity of fications, and devices for purpose of the product for which service is pro- the Agricultural Marketing Act. vided under the regulations in this sub- Subsection 203(h) of the Agricultural part. Marketing Act of 1946, as amended by (d) Official device means a stamping Pub. L. 272, 84th Congress, provides applicance, branding device, stencil, criminal penalties for various specified printed label, or any other mechani- offenses relating to official certifi- cally or manually operated tool that is cates, memoranda, marks or identifica- approved by the Administrator for the tions, and devices for making such purpose of applying any official mark marks or identifications, issued or au- or other identification to any product thorized under section 203 of said Act, or the packaging material thereof. and certain misrepresentations con- cerning the inspection or grading of ag- ADMINISTRATION ricultural products under said section. For the purposes of said subsection and § 58.3 Authority. the provisions in this part, the terms listed below shall have the respective The Administrator shall perform meanings specified: such duties as may be required in the (a) Official certificate means any form enforcement and administration of the of certification, either written or print- provisions of the Act and this part. ed (including that prescribed in § 58.18) INSPECTION OR GRADING SERVICE used under the regulations in this sub- part to certify with respect to the in- § 58.4 Basis of service. spection of dairy processing plants and the inspection, class, grade, quality, Inspection or grading service shall be size, quantity, or condition of products performed in accordance with the pro- (including the compliance of products visions of this part, the instructions and packaging material with applica- and procedures issued or approved by ble specifications). the Administrator, U.S. standards for (b) Official memorandum means any grades, Federal specifications, and initial record of findings made by an specifications as defined in a specific
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purchase contract. All services pro- § 58.9 Form of application. vided in accordance with these regula- Each application for inspection or tions shall be rendered without dis- grading service shall include such in- crimination on the basis of race, color, formation as may be required by the creed, or national origin. Administrator in regard to the type of [39 FR 986, Jan. 4, 1974. Redesignated at 42 service; kind of products and place of FR 32514, June 27, 1977, and further redesig- manufacture, processing, or packaging: nated at 46 FR 63203, Dec. 31, 1981] and location where service is desired.
§ 58.5 Where service is offered. § 58.10 Filing of application. Subject to the provisions of this part, An application for inspection or grad- inspection or grading service may be ing service shall be regarded as filed performed when a qualified inspector only when made pursuant to this sub- or grader is available, and when the fa- part. cilities and conditions are satisfactory for the conduct of the service. § 58.11 Approval of application. An application for inspection or grad- § 58.6 Supervision of service. ing service may be approved when (a) a All inspection or grading service qualified inspector or grader is avail- shall be subject to supervision by a su- able, (b) facilities and conditions are pervisory inspector or grader, Area Su- satisfactory for the conduct of the pervisor, or by the Chief, or such other service, and (c) the product has been person of the Branch as may be des- manufactured or processed in a plant ignated by the Chief. Whenever there is approved for inspection or grading evidence that inspection or grading service in accordance with the provi- service has been incorrectly performed, sions of this part and instructions a supervisor shall immediately make a issued thereunder. reinspection or regrading, and he shall § 58.12 When application may be re- supersede the previous inspection or jected. grading certificate or report with a new certificate or report showing the An application for inspection or grad- corrected information. ing service may be rejected by the Ad- ministrator (a) when the applicant fails § 58.7 Who may obtain service. to meet the requirements of the regula- tions in this subpart prescribing the An application for inspection or grad- conditions under which the service is ing service may be made by any inter- made available; (b) when the product is ested person, including, but not limited owned by, or located on the premises to, the United States, any State, coun- of, a person currently denied the bene- ty, municipality, or common carrier, fits of the Act; (c) when an individual or any authorized agent of the fore- holding office or a responsible position going. with or having a substantial financial interest or share with the applicant is § 58.8 How to make application. currently denied the benefits of the Act (a) On a fee basis. An application for or was responsible in whole or in part inspection or grading service may be for the current denial of the benefits of made in any inspection or grading of- the Act to any person; (d) when the ap- fice or with any inspector or grader. plication is an attempt on the part of a Such application may be made orally person currently denied the benefits of (in person or by telephone), in writing, the Act to obtain inspection or grading or by telegraph. If made orally, written service; (e) when the product was pro- confirmation may be required. duced from unwholesome raw material (b) On a continuous basis. Application or was produced under insanitary or for inspection or grading service on a otherwise unsatisfactory conditions; (f) continuous basis as provided in § 58.45 when the product is of illegal composi- shall be made in writing on application tion or is lacking satisfactory keeping forms as approved by the Adminis- quality; (g) when the product has been trator and filed with the Adminis- produced in a plant which has not been trator. surveyed and approved for inspection
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or grading service; (h) when fees billed posed of by any other method pre- are not paid within 30 days; or (i) when scribed by the Administrator. there is noncompliance with the Act or this part or instructions issued here- § 58.17 Order of service. under. When an application is rejected, Inspection or grading service shall be the applicant shall be notified in writ- performed, insofar as practicable and ing by the Area Supervisor or his des- subject to the availability of qualified ignated representative, the reason or inspectors or graders, in the order in reasons for the rejection. which applications are made except [37 FR 22363, Oct. 19, 1972, as amended at 53 that precedence may be given to any FR 20278, June 3, 1988] application for an appeal inspection or grading. § 58.13 When application may be with- drawn. § 58.18 Inspection or grading certifi- cates, memoranda, or reports. An application for inspection or grad- ing service may be withdrawn by the Inspection or grading certificates and applicant at any time before the serv- sampling, plant survey, and other ice is performed upon payment, by the memoranda or reports shall be issued applicant, of all expenses incurred by on forms approved by the Adminis- AMS in connection with such applica- trator. tion. § 58.19 Issuance of inspection or grad- § 58.14 Authority of applicant. ing certificates. Proof of the authority of any person An inspection or grading certificate applying for any inspection or grading shall be issued to cover a product in- service may be required in the discre- spected or graded in accordance with tion of the Administrator. Instructions issued by the Adminis- trator and shall be signed by an inspec- § 58.15 Accessibility and condition of tor or grader. This does not preclude an product. inspector or grader from granting a Each lot of product for which inspec- power of attorney to another person to tion or grading service is requested sign in his stead, if such grant of power shall be so conditioned and placed as to of attorney has been approved by the permit selection of representative sam- Administrator: Provided, That in all ples and proper determination of the cases any such certificate shall be pre- class, grade, quality, quantity, or con- pared in accordance with the facts set dition of such product. In addition, if forth in the official memorandum de- sample packages are furnished by the fined in § 58.2(b): And provided further, applicant, such samples shall be rep- that whenever a certificate is signed by resentative of the lot to be inspected or a person under a power of attorney the graded and additional samples shall be certificate should so indicate. The sig- made available for verification. The nature of the holder of the power shall room or area where the service is to be appear in conjunction with the name of performed shall be clean and sanitary, the grader or inspector who personally free from foreign odors, and shall be graded or inspected the product. provided with adequate lighting, ven- [39 FR 986, Jan. 4, 1974. Redesignated at 42 tilation, and temperature control. FR 32514, June 27, 1977, and further redesig- nated at 46 FR 63203, Dec. 31, 1981] § 58.16 Disposition of samples. Any sample of product used for in- § 58.20 Disposition of inspection or spection or grading may be returned to grading certificates or reports. the applicant at his request and at his The original of any inspection or expense if such request was made at grading certificate or report issued the time of the application for the pursuant to § 58.19, and not to exceed service. In the event the aforesaid re- four copies thereof, shall immediately quest was not made at the time of ap- upon issuance be delivered or mailed to plication for the service, the sample of the applicant or person designated by product may be destroyed, disposed of him. One copy shall be filed in the in- to a charitable organization, or dis- spection and grading office serving the
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area in which the service was per- pervisor of such inspector or grader. formed and all other copies shall be The application for appeal inspection filed in such manner as the Adminis- or grading shall state the reasons trator may approve. Additional copies therefore, and may be accompanied by of any such certificate or report may a copy of the aforesaid inspection or be supplied to any interested party as grading certificate or report or any provided in § 58.41. other information the applicant may have secured regarding the product or § 58.21 Advance information. the service from which the appeal is re- Upon request of an applicant, all or quested. Such application may be made part of the contents of any inspection orally (in person or by telephone), in or grading certificate or report issued writing, or by telegraph. If made oral- to such applicant may be telephoned or ly, written confirmation may be re- telegraphed to him, or to any person quired. designed by him, at applicant’s ex- pense. § 58.24 Record of filing time. A record showing the date and hour APPEAL INSPECTION OR GRADING AND when each such application for appeal REINSTATEMENT OF REGRADING inspection or grading is received shall § 58.22 When appeal inspection or be maintained in such manner as the grading may be requested. Administrator may prescribe. (a) An application for an appeal in- § 58.25 When an application for appeal spection or grading may be made by inspection or grading may be re- any interested party who is dissatisfied fused. with any determination stated in any inspection or grading certificate or re- The Administrator may refuse an ap- port if the identity of the samples or plication for an appeal inspection or the product has not been lost; or the grading when (a) the quality or condi- conditions under which inspection tion of the products has undergone a service was performed have not material change since the time of changed. Such application for appeal original service, (b) the identical prod- inspection or grading shall be made ucts inspected or graded cannot be within 2 days following the day on made accessible for reinspection or re- which the service was performed. Upon grading, (c) the conditions under which approval by the Administrator, the inspection service was performed have time within which an application for changed, (d) it appears that the reasons an appeal grading may be made may be for an appeal inspection or grading are extended. frivolous or not substantial, or (e) the (b) An appeal inspection shall be lim- Act or this part have not been com- ited to a review of the sampling proce- plied with. The applicant shall be dure and in analysis of the official sam- promptly notified of the reason for ple used, when, as a result of the origi- such refusal. nal inspection, the commodity was found to be contaminated with filthy, § 58.26 When an application for an ap- putrid, and decomposed material. If it peal inspection or grading may be withdrawn. is determined that the sampling proce- dures were improper, a new sample An application for appeal inspection shall be obtained. or grading may be withdrawn by the applicant at any time before the appeal § 58.23 How to obtain appeal inspec- inspection or grading is made upon tion or grading. payment, by the applicant, of all ex- Appeal inspection or grading may be penses incurred by AMS in connection obtained by filing a request therefore, with such application. (a) with the Administrator, (b) with the inspector or grader who issued the § 58.27 Order in which appeal inspec- inspection or grading certificate or re- tions or gradings are performed. port with respect to which the appeal Appeal inspections or gradings shall service is requested, or (c) with the su- be performed, insofar as practicable, in
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the order in which applications there- and such certificate or report shall for are received; and any such applica- thereupon supersede, as of the time of tion may be given precedence pursuant issuance, the inspection or grading cer- to § 58.17. tificate or report previously issued. Each reinspection or regrading certifi- § 58.28 Who shall make appeal inspec- cate or report shall clearly set forth tions or gradings. the number and date of the inspection An appeal inspection or grading of or grading certificate or report that it any product or service shall be made by supersedes. The provisions of §§ 58.18 any inspector or grader (other than the through 58.21 shall, whenever applica- one from whose service the appeal is ble, also apply to reinspection or re- made) designated for this purpose by grading certificates or reports except the Administrator; and, whenever prac- that copies shall be furnished each in- tical, such appeal inspection or grading terested party of record. shall be conducted jointly by two such inspectors or graders. § 58.32 Superseded certificates or re- ports. § 58.29 Appeal inspection or grading When any inspection or grading cer- certificate or report. tificate or report is superseded in ac- Immediately after an appeal inspec- cordance with this part, such certifi- tion or grading has been completed, an cate or report shall become null and appeal inspection or grading certificate void and, after the effective time of the or report shall be issued showing the supersedure, shall no longer represent results of the inspection or grading. the class, grade, quality, quantity, or Such certificate or report shall there- condition described therein. If the upon supersede the previous certificate original and all copies of such super- or report and will be effective retro- seded certificate or report are not re- active to the date of the previous cer- turned to the inspector or grader tificate or report. Each appeal certifi- issuing the reinspection or regrading or cate or report shall clearly set forth appeal inspection or grading certificate the number and the date of the pre- or report, the inspector or grader shall vious certificate or report which it su- notify such persons as he considers persedes. The provisions of §§ 58.18 necessary to prevent fraudulent use of through 58.21 shall, whenever applica- the superseded certificate or report. ble, also apply to appeal certificates or LICENSING OF INSPECTORS OR GRADERS reports except that copies shall be fur- nished each interested party of record. § 58.33 Who may be licensed. § 58.30 Application for reinspection or Any person processing proper quali- regrading. fications, as determined by an exam- An application for the reinspection ination for competency, held at such or regrading of any previously in- time and in such manner as may be spected or graded product may be made prescribed by the Administrator, may at any time by any interested party; be licensed to perform specified inspec- and such application shall clearly indi- tion or grading service. Each license cate the reasons for requesting the re- issued shall be signed by the Adminis- inspection or regrading. The provisions trator. of the regulations in this subpart rel- [53 FR 20278, June 3, 1988] ative to inspection or grading service shall apply to reinspection or regrading § 58.34 Suspension or revocation of li- service. cense. For good cause and in instances of § 58.31 Reinspection or regrading cer- willful wrongdoing, the Administrator tificate or report. may suspend any license issued under Immediately after a reinspection or the regulations in this subpart by giv- regrading has been completed, a rein- ing notice of such suspension to the re- spection or a regrading certificate or spective individual involved, accom- report shall be issued showing the re- panied by a statement of reasons there- sults of such reinspection or regrading; for. Within 10 days after receipt of the
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aforesaid notice and statement of rea- service by check, draft, or money order sons by such individual, he may file an payable to the Agricultural Marketing appeal in writing with the Adminis- Service and remitted promptly to the trator supported by any argument or office indicated on the bill. evidence that he may wish to offer as (c) Fees and charges for any inspec- to why his license should not be sus- tion or grading service under a cooper- pended or revoked. In conjunction ative agreement with any State or per- therewith, he may request and, in such son shall be paid in accordance with event, shall be accorded an oral hear- the terms of the cooperative agreement ing. After consideration of such argu- by the interested party making appli- ment and evidence, the Administrator cation for the service. will take such action as warranted with respect to such suspension or rev- § 58.39 Fees for holiday or other ocation. When no appeal is filed within nonworktime. the prescribed 10 days, the license is re- If an applicant requests that inspec- voked. tion or grading service be performed on § 58.35 Surrender of license. a holiday, Saturday, or Sunday or in excess of each 8-hour shift Monday Each license which is suspended or through Friday, he shall be charged for revoked shall be surrendered promptly such service at a rate of 11⁄2 times the by the licensee to his supervisor. Upon rate which would be applicable for such termination of the services of a li- censee, the license shall be surrendered service if performed during normal promptly by the licensee to his super- working hours. visor. § 58.40 Fees for appeal inspection or § 58.36 Identification. grading. Each licensee shall have his license The fees to be charged for any appeal card in his possession at all times inspection or grading shall be double while performing any function under the fees specified on the inspection or the regulations in this subpart and grading certificate from which the ap- shall identify himself by such card peal is taken: Provided, That the fee for upon request. any appeal grading requested by any agency of the U.S. Government shall be § 58.37 Financial interest of licensees. the same as set forth in the certificate No licensee shall render service on from which the appeal is taken. If the any product in which he is financially result of any appeal inspection or grad- interested. ing discloses that a material error was made in the inspection or grading ap- FEES AND CHARGES pealed from, no fee shall be required.
§ 58.38 Payment of fees and charges. § 58.41 Fees for additional copies of (a) Fees and charges for any inspec- certificates. tion or grading service shall be paid by Additional copies of any inspection the interested party, making the appli- or grading certificates (including take- cation for such service, in accordance off certificates), other than those pro- with the applicable provisions of this vided for in § 58.20 may be supplied to section and §§ 58.39 through 58.46 and, if any interested party upon payment of so required by the inspector or grader, a fee based on time required to prepare such fees and charges shall be paid in such copies at the hourly rate specified advance. in § 58.43. (b) Fees and charges for any inspec- tion or grading service performed by [54 FR 15167, Apr. 17, 1989] any inspector or grader who is a sala- ried employee of the Department shall, § 58.42 Travel expenses and other unless otherwise required pursuant to charges. paragraph (c) of this section, be paid by Charges shall be made to cover the the interested party making applica- cost of travel and other expenses in- tion for such inspection or grading curred by AMS in connection with the
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performance of any inspection or grad- not be inconsistent with the Act and ing service. this part, he may authorize such use of [53 FR 20278, June 3, 1988] official identification. Any application for such authority shall be submitted § 58.43 Fees for inspection, grading, to the Administrator in such form as and sampling. he may require. Except as otherwise provided in §§ 58.38 through 58.46, charges shall be § 58.50 Approval and form of official made for inspection, grading, and sam- identification. pling service at the hourly rate of (a) Any package label or packaging $56.00 for service performed between material which bears any official iden- 6:00 a.m. and 6:00 p.m. and $61.60 for tification shall be used only in such service performed between 6:00 p.m. manner as the Administrator may pre- and 6:00 a.m., for the time required to scribe, and such official identification perform the service calculated to the shall be of such form and contain such nearest 15-minute period, including the information as the Administrator may time required for preparation of certifi- require. No label or packaging material cates and reports and the travel time bearing official identification shall be of the inspector or grader in connec- used unless finished copies or samples tion with the performance of the serv- thereof have been approved by the Ad- ice. A minimum charge of one-half ministrator. hour shall be made for service pursuant to each request or certificate issued. (b) Inspection or grade mark per- mitted to be used to officially identify [62 FR 66258, Dec. 18, 1997] packages containing dairy products which are inspected or graded pursuant § 58.45 Fees for continuous resident services. to this part shall be contained in a shield in the form and design indicated Irrespective of the fees and charges in Figures 1, 2, and 3 of this section or provided in §§ 58.39 and 58.43, charges such other form, design, or wording as for the inspector(s) and grader(s) as- may be approved by the Administrator. signed to a continuous resident pro- gram shall be made at the rate of $51.00 per hour for services performed during the assigned tour of duty. Charges for service performed in excess of the as- signed tour of duty shall be made at a rate of 11⁄2 times the rate stated in this section. [62 FR 66258, Dec. 18, 1997]
§ 58.46 Fees for service performed under cooperative agreement. The fees to be charged and collected for any service performed under coop- erative agreement shall be those pro- vided for by such agreement.
MARKING, BRANDING, AND IDENTIFYING PRODUCT
§ 58.49 Authority to use official identi- fication. Whenever the Administrator deter- mines that the granting of authority to any person to package any product, in- spected or graded pursuant to this part, and to use official identification, pursuant to §§ 58.49 through 58.57, will
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the printed labels and packaging mate- rials bearing official identification for final approval prior to use. (60 Stat. 1087, 7 U.S.C. 1621 et seq.; 84 Stat. 1620, 21 U.S.C. 1031 et seq.) [37 FR 22363, Oct. 19, 1972, as amended at 39 FR 987, Jan. 4, 1974. Redesignated at 42 FR 32514, June 27, 1977, as amended at 43 FR 60138, Dec. 26, 1978. Redesignated at 46 FR 63203, Dec. 31, 1981] The official identification illustrated in Figure 1 is designed for use on grad- § 58.51 Information required on offi- ed product packed under USDA inspec- cial identification. tion. Figure 2 is designed for graded Each official identification shall con- product processed and packed under spicuously indicate the U.S. grade of USDA inspection. Figure 3 is des- ignated for inspected product (when the product it identifies, if there be a U.S. standards for grades are not estab- grade, or such other appropriate termi- lished) processed and packed under nology as may be approved by the Ad- USDA quality control service. The offi- ministrator. Also, it shall include the cial identification shall be printed on appropriate phrase: ‘‘Officially grad- the package label, on the carton or on ed,’’ ‘‘Officially Inspected,’’ or ‘‘Fed- the wrapper and, preferably, on one of eral-State graded.’’ When required by the main panels of the carton or wrap- the Administrator, the package label, per. The shield identification shall be carton, or wrapper bearing official not less than 3⁄4 inch by 3⁄4 inch in size, identification for dairy products shall and preferably 1 inch by 1 inch on 1- be stamped or perforated with the date pound cartons or wrappers. Consider- packed and the certificate number or a ation will be given by the Adminis- code number to indicate lot and date trator of a smaller shield on special packed. Such coding shall be made packages where the size of the label available to and approved by the Ad- 3 3 does not permit use of the ⁄4 inch by ⁄4 ministrator. inch shield. (c) Official identification under this § 58.52 Time limit for packaging in- subpart shall be limited to U.S. Grade spected or graded products with of- B or higher or to an equivalent stand- ficial identification. ard of quality for U.S. name grades or Any lot of butter which is graded for numerical score grades when U.S. packaging with official grade identi- standards for grades of a product have not been established. fication shall be packaged within 10 (d) A sketch, proof, or photocopy of days immediately following the date of each proposed label or packaging mate- grading, and any lot of natural cheese rial bearing official identification shall or dry milk shall be packaged within 30 be submitted to the Chief of the Dairy days immediately following date of Inspection Branch, Poultry and Dairy grading provided the product is prop- Quality Division, Agricultural Mar- erly stored during the 10- or 30-day pe- keting Service, U.S. Department of Ag- riod. Time limit for packaging other riculture, Washington, DC 20250, for re- inspected or graded products shall be view and tentative approval prior to as approved by the Administrator. If acquisition of a supply of material. inspected or graded product is moved (e) The firm packaging the product to another location, a reinspection or shall furnish to the Chief four copies of regrading shall be required.
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PREREQUISITES TO PACKAGING PRODUCTS § 58.57 Product not eligible for pack- WITH OFFICIAL IDENTIFICATION aging with official identification. (a) When a lot of inspected or graded § 58.53 Supervisor of packaging re- product shows unsatisfactory keeping quired. quality, other lots from the same man- The official identification of any in- ufacturing plant shall not be packaged spected or graded product, as provided with official identification. Packaging in §§ 58.50 through 58.52, this section, with official identification may be re- and §§ 58.54 through 58.57, shall be done sumed only when it is determined that only under the supervision of a super- product from such plant possesses sat- visor of packaging. The authority to isfactory keeping quality. use official identification may be (b) Any manufacturing or processing granted by the Administrator only to plant supplying product, directly or in- applicants who utilize the services of a directly, for packaging with official supervisor of packaging in accordance identification shall be surveyed and ap- with this subpart. The supervisor of proved for inspection or grading serv- packaging shall have jurisdiction over ice. the use and handling of all packaging material bearing any official identi- VIOLATIONS fication. § 58.58 Debarment of service. § 58.54 Packing and packaging room (a) The following acts or practices, or and equipment. the causing thereof, may be deemed Each applicant who is granted au- sufficient cause for the debarment, by thority to package any product with the Administrator, of any person, in- official identification and who oper- cluding any agents, officers, subsidi- ates, for such purpose, a packaging aries, or affiliates of such person, from room shall maintain the room and the any or all benefits of the Act for a equipment therein in accordance with specified period. The rules of practice this part. governing withdrawal of inspection and grading services in formal adjudicatory § 58.55 Facilities for keeping quality proceedings instituted by the Sec- samples. retary (7 CFR, part 1, subpart H) shall be applicable to such debarment ac- Each applicant granted authority, as tion. aforesaid, to package product with offi- (1) Fraud or misrepresentation. Any cial identification shall provide and willful misrepresentation or deceptive maintain suitable equipment for the or fraudulent practice or act found to purpose of incubating samples of prod- be made or committed by any person in uct. connection with: (i) The making or filing of any appli- § 58.56 Incubation of product samples. cation for any inspection or grading (a) Samples of product may be taken service, appeal reinspection, or regrad- from any lot of product which is sub- ing service; mitted for inspection or grading and (ii) The making of the product acces- packaging with official identification, sible for inspection or grading service; or sample may be taken after pack- (iii) The making, issuing, or using or aging for the purpose of determining in attempting to issue or use any inspec- accordance with provisions of this part tion or grading certificate issued pur- if such product possesses satisfactory suant to the regulations in this subpart keeping quality. or the use of any official stamp, label, (b) Samples of product may be taken or identification; for keeping quality tests in accordance (iv) The use of the terms ‘‘United with provisions of this part from any States,’’ ‘‘U.S.,’’ ‘‘Officially graded,’’ lot of product submitted for inspection ‘‘Officially Inspected,’’ ‘‘Federal-State or grading. Issuance of the inspection graded,’’ or ‘‘Government graded,’’ or or grading certificate may be withheld terms of similar import in the labeling pending completion of the tests. or advertising of any product without
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stating in conjunction therewith the tional elections, whether primary or official U.S. grade of the product; or regular, or in behalf of any party or (v) The use of any of the aforesaid candidate, or any measure to be voted terms or an official stamp, label, or upon, is prohibited. This applies to all identification in the labeling or adver- appointees, including, but not being tising of any product that has not been limited to, temporary and cooperative inspected or graded pursuant to this employees and employees on leave of part. absence with or without pay. Willful (2) Use of facsimile form. Using or at- violation of this section will constitute tempting to use a form which simu- grounds for dismissal in the case of ap- lates in whole or in part any official identification for the purpose of pur- pointees and revocation of licenses in porting to evidence the U.S. grade of the case of licensees. any product; or the unauthorized use of a facsimile form which simulates in § 58.62 Report of violations. whole or in part any official inspection Each inspector, grader, and super- or grading certificate, stamp, label, or visor of packaging shall report, in the other official inspection mark; and manner prescribed by the Adminis- (3) Mislabeling. The use of any words, trator, all violations and noncompli- numerals, letters, or facsimile form ances under the Act and this part of which simulates in whole or in part which such inspector, grader, or super- any identification purporting to be a visor of packaging has knowledge. grade when such product does not com- ply with any recognized standards in § 58.63 Other applicable regulations. general use for such grade, and such ac- tivity may be deemed sufficient cause Compliance with the provisions in for debarring such person from any or this part shall not excuse failure to all benefits of the Act. comply with any other Federal, or any (4) Willful violation of the regulations State, or municipal applicable laws or in this subpart. Willful violation of the regulations. provisions in this part or the Act, or the instructions or specifications § 58.64 OMB control numbers assigned issued thereunder. pursuant to the Paperwork Reduc- (5) Interfering with an inspector or tion Act. grader. Any interference with or ob- The following control number has struction or any attempted inter- been assigned to the information col- ference or obstruction of any inspector lection requirements in 7 CFR part 58, or grader in the performance of his du- subpart A, by the Office of Manage- ties by intimidation, threat, bribery, ment and Budget pursuant to the Pa- assault, or other improper means. perwork Reduction Act of 1980, Pub. L. (b) [Reserved]. 96–511. (60 Stat. 1087, 7 U.S.C. 1621 et seq.; 84 Stat. 1620, 21 U.S.C. 1031 et seq.) 7 CFR section where requirements are de- Current scribed OMB control [37 FR 22363, Oct. 19, 1972. Redesignated at 42 No. FR 32514, June 27, 1977, as amended at 43 FR 60138, Dec. 26, 1978. Redesignated at 46 FR 58.8(a)(b) ...... 0581Ð0126 63203, Dec. 31, 1981] 58.9 ...... 0581Ð0126 58.14 ...... 0581Ð0126 MISCELLANEOUS 58.23 ...... 0581Ð0126 58.30 ...... 0581Ð0126 § 58.61 Political activity. 58.33 ...... 0581Ð0126 58.49 ...... 0581Ð0126 All inspectors or graders are forbid- 58.50(d)(e) ...... 0581Ð0126 den during the period of their respec- 58.51 ...... 0581Ð0126 tive appointments or licenses to take 58.122(b) ...... 0581Ð0126 an active part in political management or in political campaigns. Political ac- [49 FR 6881, Feb. 24, 1984] tivities in city, county, State, or na-
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Subpart B—General Specifications there may hereafter be delegated the for Dairy Plants Approved for authority to act in his stead. USDA Inspection and Grading (c) Approved laboratory. A laboratory 1 in which the facilities and equipment Service used for official testing have been ap- proved by the Administrator as being SOURCE: 40 FR 47911, Oct. 10, 1975, unless adequate to perform the necessary offi- otherwise noted. Redesignated at 42 FR 32514, cial tests in accordance with this part, June 27, 1977, and further redesignated at 46 and operates under a USDA surveil- FR 63203, Dec. 31, 1981. lance program as set forth by the Ad- ministrator. DEFINITIONS (d) Approved plant. One or more adja- § 58.100 OMB control numbers as- cent buildings, or parts thereof, com- signed pursuant to the Paperwork prising a single plant at one location in Reduction Act. which the facilities and methods of op- The following control number has eration therein have been surveyed and been assigned to the information col- approved by the Administrator as suit- lection requirements in 7 CFR part 58, able and adequate for inspection or subpart B, by the Office of Manage- grading service in accordance with the ment and Budget pursuant to the Pa- following: perwork Reduction Act of 1980, Pub. L. (1) Shall satisfactorily meet the spec- 96–511. ifications of this subpart as determined by the Administrator. (2) Receive dairy products only from 7 CFR section where requirements are de- Current OMB control plants, transfer stations, receiving sta- scribed No. tions and cream buying stations which 58.139 ...... 0581Ð0110 satisfactorily comply with the applica- 58.148 ...... 0581Ð0110 ble requirements of this subpart as de- 58.441 ...... 0581Ð0110 termined by the Administrator. (Occa- sional shipments may be received from [49 FR 6881, Feb. 24, 1984; as amended at 61 nonapproved plants provided the prod- FR 67448, Dec. 23, 1996] uct is tested and meets the quality re- quirements for No. 2 milk.) § 58.101 Meaning of words. (e) Sanitizing treatment. Subjection of For the purpose of the regulations of a clean product contact surface to this subpart, words in the singular steam, hot water, hot air, or an accept- form shall be deemed to impart the able sanitizing solution of sufficient plural and vice versa, as the case may strength, and for a duration of time to demand. Unless the context otherwise effectively destroy microorganisms. requires, the following terms shall Sanitizing solutions shall comply with have the following meaning: 21 CFR 121.2547.2 (a) Act. The applicable provisions of (f) Resident service. Inspection or the Agricultural Marketing Act of 1946 grading service performed at a dairy (60 Stat. 1087, as amended; (7 U.S.C. manufacturing plant or grading station 1621–1627)), or any other Act of Con- by an inspector or grader assigned to gress conferring like authority. the plant or station on a continuous (b) Administrator. The Administrator basis. of the Agricultural Marketing Service (g) Dairy products. Butter, cheese or any other officer or employee of the (whether natural or processed), skim Agricultural Marketing Service of the milk, cream, whey or buttermilk Department to whom there has here- (whether dry, evaporated, stabilized or tofore been delegated, or to whom condensed), frozen desserts and any other food product which is prepared or manufactured in whole or in part from 1 Compliance with these standards does not any of the aforesaid products, as the excuse failure to comply with the provisions of the Federal Food, Drug, and Cosmetic Act, Environmental Protection Act, or applicable 2 Section 121.2547 of title 21 was redesig- laws and regulations of any State or Munici- nated as § 178.1010 at 42 FR 14305, Mar. 15, pality. 1977.
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Administrator may hereafter des- testing program under the current ignate. USDA Brucellosis Eradication Uniform (h) Grader. Any employee of the De- Methods and Rules. partment authorized by the Adminis- (2) Goat milk is the lacteal secretion, trator or any other person to whom a practically free from colostrum, ob- license has been issued by the Adminis- tained by the complete milking of one trator to investigate and certify, in ac- or more healthy goats. The goats shall cordance with the Act and this part, to be located in States meeting the cur- shippers of products and other inter- rent USDA Uniform Methods and Rules ested parties, the class, quality, quan- for Bovine Tuberculosis Eradication or tity, and condition of such products. an Accredited Free Goat Herd. Goat (i) Inspector. Any employee of the De- milk shall only be used to manufacture partment authorized by the Adminis- dairy products that are legally pro- trator or any other person to whom a vided for in 21 CFR or recognized as license has been issued by the Adminis- non-standardized traditional products trator to inspect and certify quality, normally manufactured from goats quantity and condition of products, ob- milk. serve the manufacturing, processing, (l) Official identification. Official iden- packaging and handling of dairy prod- tification is provided for use on prod- ucts, and to perform dairy plant sur- uct packed under USDA inspection. veys in accordance with the regula- Any package label or packaging mate- tions of this part. rial which bears any official identifica- (j) Inspection or grading service. Means tion shall be used only in such manner in accordance with this part, the act of as the Administrator may prescribe, (1) drawing samples of any product; (2) and such official identification shall be determining the class, grade, quality, of such form and contain such informa- composition, size, quantity, condition, tion as the Administrator may require. or wholesomeness of any product by ex- (m) Official methods. Official Methods amining each unit or representative of Analysis of the Association of Offi- samples; (3) determining condition of cial Analytical Chemists, a publication product containers; (4) identifying any of the Association of Official Analyt- product or packaging material by ical Chemists, Box 540, Benjamin means of official identification; (5) re- Franklin Station, Washington, DC grading or appeal grading of a pre- 20044. viously graded product; (6) inspecting (n) Pasteurization (Pasteurized). Pas- dairy plant facilities, equipment, and teurization shall mean that every par- operations; such as, processing, manu- ticle of product shall have been heated facturing, packaging, repackaging, and in properly operated equipment to one quality control; (7) supervision of pack- of the temperatures specified in the aging inspected or graded product; (8) table and held continuously at or above reinspection or appeal inspection; and that temperature for at least the speci- (9) issuing an inspection or grading cer- fied time (or other time/temperature tificate or sampling, inspection, or relationship equivalent thereto in mi- other report related to any of the fore- crobial destruction): going. (k) Milk. The term milk shall include FLUID PRODUCTS the following: (1) Milk is the lacteal secretion, prac- Temperature Time tically free from colostrum, obtained 145 °F (vat pasteurization) ...... 30 minutes. by the complete milking of one or 161 °F (high temperature short time pas- 15 seconds. more healthy cows. The cows shall be teurization). 191 °F (higher heat shorter time pasteur- 1.0 second. located in a Modified Accredited Area, ization). an Accredited Free State, or an Ac- 194 °F (higher heat shorter time pasteur- 0.5 second. credited Free Herd for tuberculosis as ization). ° determined by the Department. In ad- 201 F (higher heat shorter time pasteur- 0.1 second. ization). dition, the cows shall be located in 204 °F (higher heat shorter time pasteur- .05 second. States meeting Class B status or Cer- ization). tified-Free Herds or shall be involved 212 °F (higher heat shorter time pasteur- .01 second. in a milk ring testing program or blood ization).
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PRODUCTS HAVING DAIRY INGREDIENTS WITH A tices formulated by the 3–A Sanitary FAT CONTENT OF 10 PERCENT OR MORE, OR Standards Committees representing CONTAIN ADDED SWEETENERS the International Association of Milk, 150 °F ...... 30 minutes. Food and Environmental Sanitarians, 166 °F ...... 15 seconds. the Food and Drug Administration and the Dairy Industry Committee. Pub- FROZEN DESSERT MIX lished by the International Association 155 °F ...... 30 minutes. 175 °F ...... 25 seconds. of Milk, Food and Environmental Sanitarians, Box 701, Ames, Iowa. CONDENSED MILK TO BE REPASTEURIZED (x) USDA or Department. Means the 166 °F ...... 15 seconds. United States Department of Agri- (o) Plant survey. An appraisal of a culture. plant to determine the extent to which (y) Receiving Station. Any place, facilities, equipment, method of oper- premise, or establishment where milk ation, and raw material being received or dairy products are received, col- are in accordance with the provisions lected or handled for transfer to a proc- of this part. The survey shall be used essing or manufacturing plant. to determine suitability of the plant (z) Transfer station. Any place, for USDA inspection or grading serv- premise, or establishment where milk ice. or dairy products are transferred di- (p) Plant status. The extent to which rectly from one transport tank to an- a plant complies with this subpart other. shall be determined under procedures (aa) Corrosion-resistant. Those mate- as set forth by the Administrator. rials that maintain their original sur- (q) Producer. The person or persons face characteristics under prolonged who exercise control over the produc- influence of the product to be con- tion of the milk delivered to a proc- tacted, cleaning compounds and sani- essing plant or receiving station and tizing solutions, and other conditions who receive payment for this product. of the environment in which used. (r) Quality control. The inspection of the quality of the raw material and the [40 FR 47911, Oct. 10, 1975. Redesignated at 42 FR 32514, June 27, 1977, and further redesig- conditions relative to the preparation nated at 46 FR 63203, Dec. 31, 1981, as amend- of the product from its raw state ed at 50 FR 34672, Aug. 27, 1985; 58 FR 42413, through each step in the entire process. Aug. 9, 1993; 59 FR 24321, May 10, 1994; 59 FR It includes the inspection of conditions 50121, Sep. 30, 1994] under which the product is prepared, processed, manufactured, packed and PURPOSE stored. In addition, assistance and guidance is offered to improve the raw § 58.122 Approved plants under USDA inspection and grading service. milk quality, processing methods, quality, stability, and packaging and (a) Adoption of certain sound prac- handling of the finished product. tices at dairy plants will significantly (s) Regulations. The term ‘‘regula- aid the operators to manufacture more tions’’ means the provisions contained consistently, uniform high-quality sta- in this part. ble dairy products. Only dairy products (t) Shall. Expresses a provision that manufactured, processed and packaged is mandatory. in an approved plant may be graded or (u) Should. Expresses recommended inspected and identified with official nonmandatory provisions which when identification. The specifications es- followed would significantly aid in a tablished herein provide the basis for a quality improvement program. quality maintenance program which (v) Standard methods. Standard Meth- may be effectively carried forward ods for the Examination of Dairy Prod- through official inspection, grading, ucts, a publication of the American and quality control service. Public Health Association, 1790 Broad- (b) USDA inspection and grading way, New York, New York. service is provided to dairy product (w) 3–A Sanitary Standards and Accept- manufacturing plants on a voluntary ed Practice. The latest standards for basis. The operator of any dairy plant dairy equipment and accepted prac- desiring to have such a plant qualified
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as an approved plant under USDA in- PREMISES, BUILDINGS, FACILITIES, spection and grading service may re- EQUIPMENT AND UTENSILS quest surveys of such plant, premises, equipment, facilities, methods of oper- § 58.125 Premises. ation, and raw material to determine (a) The premises shall be kept in a whether they are adequate to permit clean and orderly condition, and shall inspection and grading service. The be free from strong or foul odors, cost of this survey shall be borne by smoke, or excessive air pollution. Con- the applicant. struction and maintenance of drive- ways and adjacent plant traffic areas APPROVED PLANTS should be of cement, asphalt, or similar material to keep dust and mud to a § 58.123 Survey and approval. minimum. Prior to the approval of a plant, a (b) Surroundings. The immediate sur- designated representative of the Ad- roundings shall be free from refuse, ministrator shall make a survey of the rubbish, overgrown vegetation, and plant, premises, storage facilities, waste materials to prevent harborage equipment and raw material, volume of of rodents, insects and other vermin. (c) Drainage. A suitable drainage sys- raw material processed daily, and fa- tem shall be provided which will allow cilities for handling the products at the rapid drainage of all water from plant plant. The survey shall be made at buildings and driveways, including sur- least twice a year to determine wheth- face water around the plant and on the er the facilities, equipment, method of premises, and all such water shall be operation, and raw material being re- disposed of in such a manner as to pre- ceived are adequate and suitable for vent an environmental or health haz- USDA inspection and grading service ard. in accordance with the provisions of this part. To be eligible for approval a § 58.126 Buildings. plant shall satisfactorily meet the The building or buildings shall be of specifications of this subpart as deter- sound construction and shall be kept in mined by the Administrator. good repair to prevent the entrance or harboring of rodents, birds, insects, § 58.124 Denial or suspension of plant approval. vermin, dogs, and cats. All service pipe openings through outside walls shall be Plant approval may be denied or sus- effectively sealed around the opening pended if a determination is made by a or provided with tight metal collars. designated representative of the Ad- (a) Outside doors, windows, openings, ministrator that the plant is not per- etc. All openings to the outer air in- forming satisfactorily in regard to; (a) cluding doors, windows, skylights and the classification of milk, (b) proper transoms shall be effectively protected segregation and disposal of unwhole- or screened against the entrance of some raw materials or finished prod- flies and other insects, rodents, birds, uct, (c) adequate facilities and condi- dust and dirt. All outside doors opening tion of processing equipment, (d) sani- into processing rooms shall be in good tary conditions of plant and equip- condition and fit propperly. All hinged, ment, (e) control of insects, rodents outside screen doors shall open out- and other vermin, (f) use of non-toxic ward. All doors and windows should be product contact surfaces and preven- kept clean and in good repair. Outside tion of adulteration of raw materials conveyor openings and other special- and products with chemicals or other type outside openings shall be effec- foreign material, (g) proper operating tively protected to prevent the en- procedures, (h) the maintenance of trance of flies and rodents, by the use legal composition of finished products, of doors, screens, flaps, fans or tunnels. (i) the manufacture of stable dairy Outside openings for sanitary pipelines products, of desirable keeping quality shall be covered when not in use. On characteristics, (j) proper storage con- new construction window sills should ditions for ingrpackaging methods and be slanted downward at approximately material. a 45° angle.
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(b) Walls, ceilings, partitions and posts. foot-candles of light intensity. In all The walls, ceilings, partitions, and other rooms there shall be provided at posts of rooms in which milk, or dairy least 5 foot-candles of light intensity products are processed, manufactured, when measured at a distance of 30 handled, packaged or stored (except inches from the floor. Where contami- dry storage of packaged finished prod- nation of product by broken glass is ucts and supplies) or in which utensils possible, light bulbs and fluorescent are washed and stored, shall be tubes shall be protected against break- smoothly finished with a suitable ma- age. terial of light color, which is substan- (2) There shall be adequate heating, tially impervious to moisture and kept ventilation or air conditioning for all clean. They shall be refinished as often rooms and compartments to permit as necessary to maintain a neat, clean maintenance of sanitary conditions. surface. For easier cleaning new con- Exhaust or inlet fans, vents, hoods or struction should have rounded cove at temperature and humidity control the juncture of the wall and floor in all equipment shall be provided where and receiving, pasteurizing, manufacturing, when needed, to minimize or control packaging and storage rooms. room temperatures, eliminate objec- (c) Floors. The floors of all rooms in tionable odors, and aid in prevention of which milk, or dairy products are proc- moisture condensation and mold. Inlet essed, manufactured, packaged or fans should be provided with an ade- stored or in which utensils are washed quate air filtering device to eliminate shall be constructed of tile properly dirt and dust from the incoming air. laid with impervious joint material, Ventilation systems shall be cleaned concrete, or other equally impervious periodically as needed and maintained material. The floors shall be smooth, in good repair. Exhaust outlets shall be kept in good repair, graded so that screened or provided with self closing there will be no pools of standing water louvers to prevent the entrance of in- or milk products after flushing, and all sects when not in use. openings to the drains shall be (e) Rooms and compartments. Rooms equipped with traps properly con- and compartments in which any raw structed and kept in good repair. On material, packaging, ingredient sup- new construction, bell and standpipe plies or dairy products are handled, type traps shall not be used. The manufactured, packaged or stored shall plumbing shall be so installed as to be so designed, constructed and main- prevent the back-up of sewage into the tained as to assure desirable room tem- drain lines and to the floor of the peratures and clean and orderly oper- plant. Cold storage rooms used for stor- ating conditions free from objection- age of product and starter rooms need able odors and vapors. Enclosed bulk not be provided with floor drains if the milk receiving rooms, when present, floor is sloped to drain to an exit. shall be separated from the processing Sound, smooth, wood floors which can rooms by a wall. Rooms for receiving be kept clean, may be used in rooms can milk shall be separated from the where new containers and supplies and processing rooms by a partition or by certain packaged finished products are suitable arrangement of equipment. stored. Processing rooms shall be kept free (d) Lighting and ventilation. (1) Light from equipment and materials not reg- shall be ample, natural or artificial, or ularly used. both, of good quality and well distrib- (1) Coolers and freezers. Coolers and uted. All rooms in which dairy prod- freezers where dairy products are ucts are manufactured or packaged or stored shall be clean, reasonably dry where utensils are washed shall have at and maintained at the proper uniform least 30 foot-candles of light intensity temperature and humidity to ade- on all working surfaces. Rooms where quately protect the product, and mini- dairy products are graded or examined mize the growth of mold. Adequate cir- for condition and quality shall have at culation of air shall be maintained at least 50 foot-candles of light intensity all times. They shall be free from ro- on the working surface. Restrooms and dents, insects, and pests. Shelves shall locker rooms should have at least 30 be kept clean and dry. Refrigeration
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units shall have provisions for col- form tests necessary in evaluating the lecting and disposing of condensate. quality of raw and finished products. (2) Supply room. The supply rooms or (ii) Approved laboratories shall be su- areas used for the storing of packaging pervised by the USDA resident inspec- materials; containers, and miscella- tor in all aspects of official testing and neous ingredients shall be kept clean, reporting results. Plant laboratory per- dry, orderly, free from insects, rodents, sonnel in such plants may be licensed and mold, and maintained in good re- by the USDA to perform official duties. pair. Such items stored therein shall be The AMS Science Division will provide adequately protected from dust, dirt, independent auditing of laboratory or other extraneous material and so ar- analysis functions. ranged on racks, shelves or pallets to (iii) An approved central control lab- permit access to the supplies and oratory serving more than one plant cleaning and inspection of the room. may be acceptable, if conveniently lo- Insecticides, rodenticides, cleaning cated to the dairy plants, and if sam- compounds and other nonfood products ples and results can be transmitted shall be properly labeled and seg- without undue delay. regated, and stored in a separate room (6) Starter facilities. Adequate facili- or cabinet away from milk, dairy prod- ties shall be provided for the handling ucts, ingredients or packaging supplies. of starter cultures. The facilities shall (3) Boiler rooms, shop rooms and shop not be located near areas where con- areas. The boiler, and shop rooms shall tamination is likely to occur. be separated from other rooms where (7) Grading and inspection room. When milk, and dairy products are processed, manufactured, packaged, handled or grading or inspection of product is per- stored. Shop rooms or areas should be formed the plants shall furnish a room kept orderly and reasonably free from or designated area specifically for this dust and dirt. purpose. The room or area shall be (4) Toilet and dressing rooms. Adequate suitably located, sufficient in size, well toilet and dressing room facilities shall lighted (see § 58.126d), ventilated and be conveniently located. the temperature shall be not less than ° (i) Toilet rooms shall not open di- 60 F. It shall be kept clean and dry, rectly into any room in which milk or free from foreign odors and reasonably dairy products are processed, manufac- free from disturbing elements which tured, packaged or stored; doors shall would interfere with proper concentra- be self-closing; ventilation shall be pro- tion by the grader or inspector. The vided by mechanical means to the grading or inspection room or area outer air; fixtures shall be kept clean shall be equipped with a table or desk and in good repair. and convenient facilities for washing (ii) All employees shall be furnished hands. with a locker or other suitable facility (8) Resident inspector’s facilities. In and the lockers and dressing rooms resident plants, an office or space shall shall be kept clean and orderly. Ade- be provided for official purposes. The quate handwashing facilities shall be room or space should be conveniently provided. Legible signs shall be posted located in or near the approved labora- conspicuously in each toilet or dressing tory, adequate in size, and equipped room directing employees to wash with desk and a lockable storage sup- their hands before returning to work. ply cabinet, and clothes locker. It shall (5) Laboratory. (i) Consistent with the be well lighted, ventilated or air condi- size and type of plant and the volume tioned, and heated. Custodial service of dairy products manufactured, an shall be furnished on a regular basis. adequately equipped laboratory shall (9) Lunch rooms and eating areas. be maintained and properly staffed When these areas are provided, they (i) with qualified and trained personnel shall be kept clean and orderly, (ii) for quality control and analytical test- should not open directly into any room ing. The laboratory should be located in which milk or dairy products are reasonably close to the processing ac- processed, manufactured or packaged, tivity and be of sufficient size to per- and (iii) signs shall be posted directing
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employees to wash their hands before dling products. Vats for washing equip- returning to work. ment or utensils shall not be used as hand-washing facilities. Containers [40 FR 47911, Oct. 10, 1975. Redesignated at 42 FR 32514, June 27, 1977, and further redesig- shall be provided for used towels and nated at 46 FR 63203, Dec. 31, 1981, as amend- other wastes. The containers may be ed at 58 FR 42413, Aug. 9, 1993; 59 FR 24321, metal or plastic, disposable or reuse- May 10, 1994; 59 FR 50121, Sept. 30, 1994] able and should have self-closing cov- ers. § 58.127 Facilities. (d) Steam. Steam shall be supplied in (a) Water supply. There shall be an sufficient volume and pressure for sat- ample supply of both hot and cold isfactory operation of each applicable water of safe and sanitary quality, piece of equipment. Culinary steam with adequate facilities for its proper used in direct contact with milk or distribution throughout the plant, and dairy products shall be free from harm- protected against contamination. ful substances or extraneous material Water from other facilities, when offi- and only those boiler water additives cially approved, may be used for boiler which meet the requirements of 21 CFR feed water and condenser water pro- 121.1088 shall be used, or a secondary vided that such water lines are com- steam generator shall be used in which pletely separated from the water lines soft water is converted to steam and no carrying the sanitary water supply, boiler compounds are used. Steam and the equipment is so constructed traps, strainers and condensate traps and controlled as to preclude contami- shall be used wherever applicable to in- nation of product contact surfaces. sure a satisfactory and safe steam sup- There shall be no cross connection be- ply. Culinary steam shall comply with tween potable water lines and non-po- the recommended practices for ‘‘Pro- table water lines or between public and ducing Culinary Steam for Processing private water supplies. Bacteriological Milk and Milk Products’’ as published examinations shall be made of the by the National Association of Food plant’s sanitary water supply taken at and Dairy Equipment Manufacturers, the plant at least twice a year, or as Washington, DC, April 1963 or latest re- often as necessary to determine safety vision thereof. and suitability as related to product (e) Air under pressure. The method for keeping quality for use in manufac- supplying air under pressure, which tured products shall be made by a comes in contact with milk or dairy USDA or State agency laboratory ex- products or any product contact sur- cept for supplies that are regularly face shall comply with the 3–A Accept- tested for purity and bacteriological ed Practices for Supplying Air Under quality, and approved by the local Pressure. health officer. The results of all water (f) Disposal of wastes. Dairy wastes tests shall be kept on file at the plant shall be properly disposed of from the for which the test was performed. plant and premises consistent with re- The location, construction, and oper- quirements imposed by the Environ- ation of any well shall comply with mental Protection Act. The sewer sys- regulations of the appropriate agency. tem shall have sufficient slope and ca- (b) Drinking-water facilities. Drinking- pacity to readily remove all waste from water facilities of a sanitary type shall the various processing operations. be provided in the plant and should be Where a public sewer is not available, conveniently located. all wastes shall be properly disposed of (c) Hand-washing facilities. Conven- so as not to contaminate milk equip- ient hand-washing facilities shall be ment or to create a nuisance or public provided, including hot and cold run- health hazard. Containers used for the ning water, soap or other detergents, collection and holding of wastes shall and sanitary single service towels or be constructed of metal, plastic, or air driers. Such accommodations shall other equally impervious material and be located in or adjacent to toilet and kept covered with tight fitting lids. dressing rooms and also at such other Waste shall be stored in an area or places in the plant as may be essential room in a manner to protect it from to the cleanliness of all personnel han- flies and vermin. Solid wastes shall be
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disposed of regularly and the con- floor and protected sufficiently with tainers cleaned before reuse. Accumu- the necessary covers or baffles to pre- lation of dry waste paper and card- vent contamination from splash, con- board shall be kept to a minimum and densate and drippage. Where necessary disposed of in a manner that is envi- to provide easy access for cleaning of ronmentally acceptable. floors and adjacent wall areas, the re- ceiving tank shall be equipped with § 58.128 Equipment and utensils. wheels or casters to allow easy re- (a) General construction, repair and in- moval. stallation. The equipment and utensils (c) Can washers. Can washers shall used for the processing of milk and have sufficient capacity and ability to manufacture of dairy products shall be discharge a clean dry can and cover constructed to be readily demountable and shall be kept properly timed in ac- where necessary for cleaning and sani- cordance with the instructions of the tizing. The product contact surfaces of manufacturer. They should be equipped all utensils and equipment such as with proper temperature controls on holding tanks, pasteurizers, coolers, the wash and rinse tanks and the fol- vats, agitators, pumps, sanitary piping lowing additional devices: Prerinse jet, and fittings or any specialized equip- wash tank solution feeder, can sani- ment shall be constructed of stainless tizing attachment, forced air vapor ex- steel, or other materials which under haust, and removable air filter on dry- conditions of intended use are as equal- ing chamber. The water and steam ly corrosion resistant. Non-metallic lines supplying the washer shall main- parts other than glass having product tain a reasonably uniform pressure and contact surfaces shall comply with 3–A if necessary be equipped with pressure Sanitary Standards for Plastic or Rub- regulating valves. The steam pressure ber and Rubber-Like Materials. Equip- to the can washer should be not less ment and utensils used for cleaning than 80 pounds, and the temperature of shall be in an acceptable condition, the wash and final rinse solution such as not rusty, pitted or corroded. should be automatically controlled and All equipment and piping shall be de- not exceed 140 °F. signed and installed so as to be easily (d) Product storage tanks or vats. Stor- accessible for cleaning, and shall be age tanks or vats shall be fully en- kept in good repair, free from cracks closed or tightly covered and well insu- and corroded surfaces. New or rear- lated. The entire interior surface, agi- ranged equipment, shall be set away tator and all appurtenances shall be ac- from any wall or spaced in such a man- cessible for thorough cleaning and in- ner as to facilitate proper cleaning and spection. Any opening at the top of the to maintain good housekeeping. All tank or vat including the entrance of parts or interior surfaces of equipment, the shaft shall be suitably protected pipes (except certain piping cleaned-in- against the entrance of dust, moisture, place) or fittings, including valves and insects, oil or grease. The sight glasses, connections shall be accessible for in- if used, shall be sound, clear, and in spection. Milk and dairy product good repair. Vats which have hinged pumps shall be of a sanitary type and covers shall be easily cleaned and shall easily dismantled for cleaning or shall be so designed that moisture, or dust be of specially approved construction on the surface cannot enter the vat to allow effective cleaning in place. when the covers are raised. If the stor- All C.I.P. systems shall comply with age tanks or vats are equipped with air the 3–A Accepted Practices for Perma- agitation, the system shall be of an ap- nently Installed Sanitary Product, proved type and properly installed in Pipelines and Cleaning Systems. accordance with the 3–A Accepted (b) Weigh cans and receiving tanks. Practices for Supplying Air Under Weigh cans and receiving tanks shall Pressure. Storage tanks or vats in- comply with the 3–A Sanitary Stand- tended to hold product for longer than ards for Weigh Cans and Receiving approximately 8 hours shall be Tanks for Raw Milk and shall be easily equipped with adequate refrigeration accessible for cleaning both inside and and/or have adequate insulation. New outside and shall be elevated above the or replacement storage tanks or vats
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shall comply with the appropriate 3–A ing to the 3–A Accepted Practices, the Sanitary Standards for Storage Tanks timing pump or device and the recorder for Milk and Milk Products or Sanitary controller shall be sealed at the correct Standards for Silo-Type Storage Tanks setting to assure pasteurization. The for Milk and Milk Products and shall system should be rechecked semi-annu- be equipped with thermometers in good ally to assure continued compliance operating order. with the 3–A Accepted Practices. Seal- (e) Separators. All product contact ing and rechecking of the unit shall be surfaces of separators shall be free performed by the control authority from rust and pits and insofar as prac- having jurisdiction. When direct steam ticable shall be of stainless steel or pasteurizers are used, the steam, prior other equally noncorrosive metals. to entering the product, shall be con- (f) Coil or dome type batch pasteurizers. ducted through a steam strainer and a Coil or dome type batch pasteurizers steam purifier equipped with a steam shall be stainless steel lined and if the trap and only steam meeting the re- coil is not stainless steel or other quirements for culinary steam shall be equally noncorrosive metal it shall be used. properly tinned over the entire surface. (h) Thermometers and recorders—(1) In- Sanitary seal assemblies at the shaft dicating thermometers. (i) Long stem in- ends of coil vats shall be of the remov- dicating thermometers which are accu- able type, except that existing equip- rate within 0.5 °F., plus or minus, for ment not provided with this type gland the applicable temperature range, shall will be acceptable if the packing glands be provided for checking the tempera- are maintained and operated without ture of pasteurization and cooling of adverse effects. New or replacement products in vats and checking the ac- units shall be provided with removable curacy of recording thermometers. packing glands. Dome type pasteurizer (ii) Short stem indicating thermom- agitators shall be stainless steel except eters, which are accurate within 0.5 °F., that any non-metallic parts shall com- plus or minus, for the applicable tem- ply with 3–A Sanitary Standards for perature range, shall be installed in the Plastic or Rubber and Rubberlike Ma- proper stationary position in all terials, as applicable. Each pasteurizer pasteurizers. Storage tanks where tem- used for heating product at a tempera- perature readings are required shall ture of 5 °F. or more above the min- have thermometers which are accurate imum pasteurization temperature need within 2.0 °F., plus or minus. not have the airspace heater. It shall (iii) Air space indicating thermom- be equipped with an airspace thermom- eters, where applicable, which are ac- eter to insure a temperature at least 5 curate within 1.0 °F., plus or minus, for °F. above that required for pasteuriza- the proper temperature range shall tion of the product. There shall be ade- also be installed above the surface of quate means of controlling the tem- the products pasteurized in vats, to perature of the heating medium, Batch make certain that the temperature of pasteurizers shall have temperature in- the foam and/or air above the products dicating and recording devices. pasteurized also received the required (g) Short time pasteurizing systems. minimum temperature treatment. When pasteurization is intended or re- (2) Recording thermometers. (i) Record- quired, an approved timing pump or de- ing thermometers that are accurate vice, recorder-controller, automatic within 1 °F., plus or minus, for the ap- flow diversion valve and holding tube plicable temperature range, shall be or its equivalent, if not a part of the used on each heat treating, pasteur- existing equipment, shall be installed izing or thermal processing unit to on all such equipment used for pasteur- record the heating process. ization, to assure complete pasteuriza- (ii) Additional use of recording ther- tion. The entire facility shall comply mometers accurate within 2 °F., plus or with the 3–A Accepted Practices for the minus may be required where a record Sanitary Construction, Installation, of temperature or time of cooling and Testing and Operation of High Tem- holding is of significant importance. perature Short Time Pasteurizers. (iii) Recorder charts shall be marked After the unit has been tested accord- to show date and plant identification,
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reading of the indicating thermometer Minimum tolerance at a particular referenced reading point Ounces Pounds on the recording chart, amount and name of product, product temperature Load in pounds: 0 to 4 inclusive ...... 1⁄32 0.002 at which the ‘‘cut-in’’ and ‘‘cut-out’’ 5 to 10 inclusive ...... 1⁄16 .004 function, record of the period in which 11 to 20 inclusive ...... 1⁄8 .008 flow diversion valve is in forward-flow 21 to 30 inclusive ...... 3⁄16 .012 31 to 50 inclusive ...... 1⁄2 .031 position, signature or initials of oper- 51 to 500 inclusive ...... 3⁄4 .047 ator. (i) Surface coolers. Surface coolers (2) Large capacity scales shall be ca- shall be equipped with hinged or re- pable of the following accuracy, and movable covers for the protection of shall be graduated in no higher than 1⁄4 the product. The edges of the fins shall pound graduations for scales of capac- 1 be so designed as to divert condensate ity of up to 250 pounds; ⁄2 pound grad- on nonproduct contact surfaces away uations for scales above 250 pounds ca- pacity. from product contact surfaces. All gas- kets or swivel connections shall be (This table taken from the presently leak proof. effective 1973 revision.) (j) Plate type heat exchangers. Plate Minimum tolerance type heat exchanger shall comply with Ounces Pounds the 3–A Sanitary Standards Plate Type Heat Exchangers for Milk and Milk Load in pounds: 101 to 150 inclusive ...... 11⁄4 0.078 Products. All gaskets shall be tight 151 to 250 inclusive ...... 2 .125 and kept in good operating order. 251 to 500 inclusive ...... 4 .250 Plates shall be opened for inspection by 501 to 1000 inclusive ...... 8 .500 1001 to 2500 inclusive ...... 1.0 the operator at sufficiently frequent intervals to determine if the equip- Compliance shall be determined by the ment is clean and in satisfactory condi- appropriate regulatory authority. tion. A cleaning regimen should be (n) Homogenizers. Homogenizers and posted to insure proper cleaning proce- high pressure pumps of the plunger dures between inspection periods. type shall comply with the 3–A Sani- (k) Internal return tubular heat ex- tary Standards for Homogenizers and changers. Internal return tubular heat Pumps of the Plunger Type and shall exchangers shall comply with the 3–A be disassembled and thoroughly Sanitary Standards for Internal Return cleaned after use. Tubular Heat Exchangers for Use with (o) New equipment and replacements. Milk and Milk Products. New equipment and replacements, in- (l) Pumps. Pumps used for milk, and cluding all plastic parts and rubber and dairy products shall be of the sanitary rubberlike materials for parts and gas- type and constructed to comply with 3– kets having product contact surfaces, A Sanitary Standards for Pumps for shall comply with the then current 3–A Milk and Milk Products. Unless pumps Sanitary Standards. If 3–A Sanitary are specifically designed for effective Standards are not available, such equipment and replacements shall cleaning-in-place they shall be dis- meet the general requirements of this assembled and thoroughly cleaned section. Only material that is sanitary, after use. readily cleanable and non-toxic shall (m) Scales. All scales shall comply be used for product contact surfaces, with National Bureau of Standards parts and gaskets. Handbook 44. (Latest revision). (p) Vacuumizing equipment. The vacu- (1) Small capacity scales shall be ca- um chamber, as used for flavor control, pable of the following accuracy, and shall be made of stainless steel or other shall be graduated in no higher than equally corrosion resistant metal. The one ounce graduations. (This table unit shall be constructed to facilitate taken from the presently effective 1973 cleaning and all product contact sur- revision.) faces shall be accessible for inspection.
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Vacuum chambers located on the pas- tact with the processing or handling of teurized side of the unit shall be iso- dairy products, containers or equip- lated by means of a vacuum breaker ment should have a medical and phys- and a positive activated check valve on ical examination by a registered physi- the product inlet side and a vacuum cian or by the local department of breaker and a positive activated check health at the time of employment. An valve on the discharge side. If direct employee returning to work following steam is used, it should also be illness from a communicable disease equipped with a ratio controller to reg- shall have a certificate from the at- ulate the composition when applicable tending physician to establish proof of to the finished product. Only steam complete recovery. which meets the requirements for cul- inary steam shall be used. The incom- PROTECTION AND TRANSPORT OF RAW ing steam supply shall be regulated by MILK AND CREAM an automatic solenoid valve which will cut off the steam supply in the event § 58.131 Equipment and facilities. the flow diversion valve of the (a)(1) Milk cans. Cans used in trans- pasteurizer is not in the forward flow position. Condensers when used shall porting milk from dairy farm to plant be equipped with a water level control shall be of such construction (pref- and an automatic safety shutoff valve. erably seamless with umbrella lids) as to be easily cleaned, and shall be in- PERSONNEL, CLEANLINESS AND HEALTH spected, repaired, and replaced as nec- essary to exclude substantially the use § 58.129 Cleanliness. of cans and lids with open seams, All employees shall wash their hands cracks, rust, milkstone, or any unsani- before beginning work and upon re- tary condition. Adequate provisions turning to work after using toilet fa- should be made so that milk in cans cilities, eating, smoking or otherwise will be cooled immediately after milk- soiling their hands. They shall keep ing to 50 °F. or lower unless delivered their hands clean and follow good hygi- to the plant within two hours after enic practices while on duty. Expec- milking. torating or use of tobacco in any form (2) Farm bulk tanks. Farm bulk tanks shall be prohibited in each room and shall comply with 3–A Sanitary Farm compartment where any milk, dairy Cooling and Holding Tanks or 3–A San- products, or supplies are prepared, itary Standards for Farm Cooling and stored or otherwise handled. Clean Holding Tanks or 3–A Sanitary Stand- white or light-colored washable or dis- ards for Farm Milk Storage Tanks as posable outer garments and caps (paper applicable. They shall be installed in a caps, hard hats, or hair nets accept- milk house in accordance with the re- able) shall be worn to adequately pro- quirements of the regulatory agency in tect the hair and beards when grown by jurisdiction. The bulk cooling tanks all persons engaged in receiving, test- shall be designed and equipped with re- ing, processing milk, manufacturing, packaging or handling dairy products. frigeration to permit the cooling of the milk to 40 °F. or lower within two § 58.130 Health. hours after milking, and maintain it at 45 °F. or below until picked up. No person afflicted with a commu- nicable disease shall be permitted in (b)(1) Receiving stations. Receiving any room or compartment where milk stations shall comply with the applica- and dairy products are prepared, manu- ble sections of this subpart covering factured or otherwise handled. No per- premises, buildings, facilities, equip- son who has a discharging or infected ment, utensils, personnel, cleanliness wound, sore or lesion on hands, arms or and health. other exposed portion of the body shall (2) Transfer stations. Transfer stations work in any dairy processing rooms or shall comply with the applicable sec- in any capacity resulting in contact tions of this subpart covering premises, with milk, or dairy products. Each em- floors, lighting, water supply, hand- ployee whose work brings him in con- washing facilities, disposal of wastes,
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general construction, repair and instal- manholes should be equipped with an lation of equipment, piping and uten- adequate filtering system during load- sils and personnel—cleanliness and ing and unloading. New and replace- health. As climatic and operating con- ment transport tanks shall comply ditions require the transfer station with 3–A Sanitary Standards for Stain- shall comply with the applicable sec- less Steel Automotive Milk and Milk tions for walls, ceilings, doors and win- Products Transportation Tanks for dows. Bulk Delivery and/or Farm Pick-up (3) Cream stations. Cream stations Service. shall provide adequate protection and (3) Facilities for cleaning and sani- facilities for the handling, transferring tizing. Enclosed or covered facilities (as and cooling of farm separated cream. climatic conditions require) shall be The area shall be large enough to avoid available for washing and sanitizing of undue crowding with a normal volume transport tanks, piping, and acces- of business and shall be separated from sories, at central locations or at all other areas and the outside by self plants that receive or ship milk or closing, tight fitting doors. All open- milk products in transport tanks. ings shall be screened during fly sea- (d) Transfer of milk to transport tank. son. The floor, walls and ceiling shall Milk shall be transferred under sani- be of satisfactory construction, in good tary conditions from farm bulk tanks repair and kept clean. Lighting and through stainless steel piping or ap- ventilation shall meet the require- proved tubing. The sanitary piping and ments of § 58.126(d). Cooling facilities tubing shall be capped when not in use. shall be provided to cool the cream to 50 °F. or lower unless shipped within 8 QUALITY SPECIFICATIONS FOR RAW MILK hours after receipt. Facilities shall be provided to wash, sanitize and store § 58.132 Basis for classification. cans and equipment used in the oper- The quality classification of raw ation. The cream should not be more milk for manufacturing purposes from than 4 days old when picked up for de- each producer shall be based on an livery to the processing plant. organoleptic examination for appear- (c)(1) Transporting milk or cream. Vehi- ance and odor, a drug residue test, and cles used for the transportation of can quality control tests for sediment con- milk or cream shall be of the enclosed tent, bacterial estimate and somatic type, constructed and operated to pro- cell count. All milk received from pro- tect the product from extreme tem- ducers shall not exceed the Food and perature, dust, or other adverse condi- Drug Administration’s established lim- tions and they shall be kept clean. its for pesticide, herbicide and drug Decking boards or racks shall be pro- residues. Producers shall be promptly vided where more than one tier of cans notified of any shipment or portion is carried. Cans or vehicles used for the thereof of their milk that fails to meet transportation of milk from the farm any of these quality specifications. to the plant shall not be used for trans- porting skim milk, buttermilk, or [58 FR 26912, May 6, 1993]’ whey to producers. (2) Transport tanks. The exterior shell § 58.133 Methods for quality and shall be clean and free from open seams wholesomeness determination. or cracks which would permit liquid to (a) Appearance and odor. The appear- enter the jacket. The interior shell ance of acceptable raw milk shall be shall be stainless steel and so con- normal and free of excessive coarse structed that it will not buckle, sag or sediment when examined visually or by prevent complete drainage. All product an acceptable test procedure. The milk contact surfaces shall be smooth, eas- shall not show any abnormal condition ily cleaned and maintained in good re- (including, but not limited to, curdled, pair. The pump and hose cabinet shall ropy, bloody or mastitic condition), as be fully enclosed with tight fitting indicated by sight or other test proce- doors and the inlet and outlet shall be dures. The odor shall be fresh and provided with dust covers to give ade- sweet. The milk shall be free from ob- quate protection from road dust. Tank jectionable feed and other off-odors
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that adversely affect the finished prod- consecutive somatic cell count tests do uct. not exceed 1,000,000 per ml. The sam- (b) Somatic cell count. (1) A laboratory ples shall be taken at a rate of not examination to determine the level of more than two per week on separate somatic cells shall be made at least days within a 3-week period. four times in each 6-month period at ir- (c) Drug residue level. (1) USDA-ap- regular intervals on milk received from proved plants shall not accept for proc- each patron. essing any milk testing positive for (2) A confirmatory test for somatic drug residue. All milk received at cells shall be done when a herd sample USDA-approved plants shall be sam- exceeds either of the following screen- pled and tested, prior to processing, for ing test results: beta lactam drug residue. When di- (i) California Mastitis Test—Weak rected by the regulatory agency, addi- Positive (CMT 1). tional testing for other drug residues (ii) Wisconsin Mastitis Test—WMT shall be performed. Samples shall be value of 18 mm. analyzed for beta lactams and other (3) The confirmatory test for somatic drug residues by methods evaluated by cells shall be performed by using one of the Association of Official Analytical the following procedures: Chemists (AOAC) and accepted by the (i) Direct Microscopic Somatic Cell Food and Drug Administration (FDA) Count (Single Strip Procedure). as effective in determining compliance Pyronin Y-methyl green stain shall be with ‘‘safe levels’’ or established toler- used for goat milk. ances. ‘‘Safe levels’’ and tolerances for (ii) Electronic Somatic Cell Count. particular drugs are established by the (iii) Optical Somatic Cell Count. FDA. Other test methods evaluated by (4) The results of the confirmatory the Virginia Polytechnic Institute and test for somatic cells shall be the offi- State University, or by other institu- cial result. tions using equivalent evaluation pro- (5) Whenever the confirmatory so- cedures, and determined to dem- matic cell count indicates the presence onstrate accurate compliance results, of more than 1,000,000 somatic cells per may be employed on a temporary basis ml., the following procedures shall be until they are evaluated by the AOAC applied: and accepted or rejected by the FDA. (i) The producer shall be notified (2) Individual producer milk samples with a warning of the excessive so- for beta lactam drug residue testing matic cell count. shall be obtained from each milk ship- (ii) Whenever two of the last four ment as follows: consecutive somatic cell counts exceed (i) Milk in farm bulk tanks. A sample 1,000,000 per ml., the appropriate state shall be taken at each farm and shall regulatory authority shall be notified include milk from each farm bulk and a written notice given to the pro- tank. ducer. This notice shall be in effect as (ii) Milk in cans. A sample shall be long as two of the last four consecutive formed separately at the receiving samples exceed 1,000,000 per ml. plant for each can milk producer in- (6) An additional sample shall be cluded in a delivery, and shall be rep- taken after a lapse of 3 days but within resentative of all milk received from 21 days of the notice required in para- the producer. graph (b)(5)(ii) of this section. If this (3) Load milk samples for beta sample also exceeds 1,000,000 per ml., lactam drug residue testing shall be ob- subsequent milkings shall not be ac- tained from each milk shipment as fol- cepted for market until satisfactory lows: compliance is obtained. Shipment may (i) Milk in bulk milk pickup tankers. A be resumed and a temporary status as- sample shall be taken from the bulk signed to the producer by the appro- milk pickup tanker after its arrival at priate State regulatory agency when the plant and prior to further commin- an additional sample of herd milk is gling. tested and found satisfactory. The pro- (ii) Milk in cans. A sample rep- ducer may be assigned a full reinstate- resenting all of the milk received on a ment status when three out of four shipment shall be formed at the plant,
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using a sampling procedure that in- (c) Frequency of tests. At least once cludes milk from every can on the ve- each month, at irregular intervals, the hicle. milk from each producer shall be test- (4) Follow-up to positive-testing sam- ed as follows: ples. (i) When a load sample tests posi- (1) Milk in cans. One or more cans of tive for drug residue, the appropriate milk selected at random from each pro- State regulatory agency shall be noti- ducer. fied immediately of the positive test (2) Milk in farm bulk tanks. A sample result and of the intended disposition shall be taken from each farm bulk of the shipment of milk containing the tank. drug residue. (d) Acceptance or rejection of milk. If (ii) Each individual producer sample the sediment disc is classified as No. 1, represented in the positive-testing load No. 2, or No. 3 the producer’s milk may sample shall be singly tested to deter- be accepted. If the sediment disc is mine the producer of the milk sample classified No. 4 the milk shall be re- testing positive for drug residue. Iden- jected: Provided that, If the shipment of tification of the producer responsible milk is commingled with other milk in for producing the milk testing positive a transport tank the next shipment for drug residue, and details of the shall not be accepted until its quality final disposition of the shipment of has been determined before being milk containing the drug residue, shall picked up; however, if the person mak- be reported immediately to the appro- ing the test is unable to get to the priate agency. farm before the next shipment it may (iii) Milk shipment from the producer be accepted but no further shipments identified as the source of milk testing shall be accepted unless the milk positive for drug residue shall cease meets the requirements of No. 3 or bet- immediately and may resume only ter. In the case of milk classified as No. after a sample from a subsequent milk- 3 or No. 4, if in cans, all cans shall be ing does not test positive for drug res- tested. Producers of No. 3 or No. 4 milk idue. (cans or bulk) shall be notified imme- diately and shall be furnished applica- [50 FR 34672, Aug. 27, 1985, as amended at 58 ble sediment discs and the next ship- FR 26912, May 6, 1993] ment shall be tested. (e) Retests. On test of the next ship- § 58.134 Sediment content. ment (if in cans, all cans shall be test- (a) Method of testing. Methods for de- ed) milk classified as No. 1, No. 2, or termining the sediment content of the No. 3 may be accepted, but No. 4 milk milk of individual producers shall be shall be rejected. Retests of bulk milk those described in the latest edition of classified as No. 4 shall be made before Standard Methods for the Examination pickup. The producers of No. 3 or No. 4 of Dairy Products. Sediment content milk shall be notified immediately, shall be based on comparison with ap- furnished applicable sediment discs and plicable charts of the United States the next shipment tested. Sediment Standards for Milk and Milk This procedure of retesting successive ship- Products, subpart T, § 58.2728 through ments and accepting probational (No. 3) milk 58.2732, of this part. and rejecting No. 4 milk may be continued (b) Sediment content classification. for not more than 10 calendar days. If at the Milk shall be classified for sediment end of this time all of the producer’s milk does not meet the acceptable sediment con- content, regardless of the results of the tent classification (No. 1 or No. 2), it shall be appearance and odor examination re- rejected. quired in § 58.133(a), as follows: [40 FR 47911, Oct. 10, 1975, Redesignated at 42 USDA SEDIMENT STANDARD FR 32514, June 27, 1977, and further redesig- nated at 46 FR 63203, Dec. 31, 1981, as amend- No. 1 (acceptable)—not to exceed 0.50 mg. ed at 50 FR 34673, Aug. 27, 1985] or equivalent. No. 2 (acceptable)—not to exceed 1.50 mg. § 58.135 Bacterial estimate. or equivalent. No. 3 (probational, not over 10 days)—not (a) Method of testing. Methods for de- to exceed 2.50 mg. or equivalent. termining the bacterial estimate of the No. 4 (reject)—over 2.50 mg. or equivalent. milk of individual producers shall be
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those described in the latest edition of fication for more than 10 calendar days Standard Methods for the Examination (§ 58.134); of Dairy Products. (b) The milk has been classified (b) Bacterial estimate classification. ‘‘Undergrade’’ for bacterial estimate Milk shall be classified for bacterial es- for more than 4 successive weeks timate by one of the following meth- (§ 58.135); ods: (c) Three of the last five milk sam- ples have exceeded the maximum so- Bacterial esti- Direct Microscopic count, standard plate matic cell count level of 1,000,000 per mate classifica- count or plate loop count tion ml. (§ 58.133(b)(6)); or No. 1 ...... Not over 500,000 per ml. (d) The producer’s milk shipments to No. 2 ...... Not over 1,000,000 per ml. either the Grade A or the manufac- Undergrade ...... Over 1,000,000 per ml. turing grade milk market currently are not permitted due to a positive (c) Frequency of tests. At least once drug residue test (§ 58.133(c)(4)). each month, at irregular intervals, a mixed sample of each producer’s milk [58 FR 26913, May 6, 1993] shall be tested. (d) Acceptance of milk. If the sample of § 58.138 Quality testing of milk from milk is classified as No. 1 or No. 2 the new producers. producer’s milk may be accepted with- A quality examination and tests out qualification. If the sample is clas- shall be made on the first shipment of sified as ‘‘Undergrade’’ (probational) milk from a producer shipping milk to the producer’s milk may be accepted a plant for the first time or resuming for a temporary period of 4 weeks. The shipment to a plant after a period of producer of ‘‘Undergrade’’ milk shall be non-shipment. The milk shall meet the notified immediately. requirements for acceptable milk, so- (e) Retests. Additional samples shall matic cell count and drug residue level be tested and classified at least weekly (§§ 58.133, 58.134 and 58.135). The buyer and the producer notified immediately shall also confirm that the producer’s of the results. This procedure of testing milk is currently not excluded from at least weekly and accepting the market (§ 58.137). Thereafter, the ‘‘Undergrade’’ milk may be continued milk shall be tested in accordance with for a time period not exceeding four the provisions in §§ 58.133, 58.134 and weeks. If at the end of this time the 58.135. producer’s milk does not meet the ac- ceptable bacterial estimate require- [58 FR 26913, May 6, 1993] ments (No. 1 or No. 2), it shall not be accepted. § 58.139 Record of tests. Accurate records listing the results [40 FR 47911, Oct. 10, 1975. Redesignated at 42 FR 32514, June 27, 1977, and further redesig- of quality and drug residue tests for nated at 46 FR 63203, Dec. 31, 1981, as amend- each producer shall be kept on file at ed at 50 FR 34673, Aug. 27, 1985] the plant. Additionally, the plant shall obtain the quality and drug residue § 58.136 Rejected milk. test records (§ 58.148(a), (e) and (g)) for A plant shall reject specific milk any producer transferring milk ship- from a producer if the milk fails to ment from another plant. These meet the requirements for appearance records shall be available for examina- and odor (§ 58.133(a)), if it is classified tion by the inspector. No. 4 for sediment content (§ 58.134), or [58 FR 26913, May 6, 1993] if it tests positive for drug residue (§ 58.133(c)). § 58.140 Field service. [58 FR 26913, May 6, 1993] A representative of the plant shall arrange to promptly visit the farm of § 58.137 Excluded milk. each producer whose milk tests posi- A plant shall not accept milk from a tive for drug residue, exceeds the max- producer if: imum somatic cell count level, or does (a) The milk has been in a proba- not meet the requirements for accept- tional (No. 3) sediment content classi- able milk. The purpose of the visit
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shall be to inspect the milking equip- (b) The bacteriological quality of ment and facilities and to offer assist- commingled milk in storage tanks ance to improve the quality of the pro- shall not exceed 3,000,000/ml. ducer’s milk and eliminate any poten- tial causes of drug residues. A rep- § 58.144 Pasteurization or ultra-pas- resentative of the plant should rou- teurization. tinely visit each producer as often as When pasteurization or ultra-pas- necessary to assist and encourage the teurization is intended or required, or production of high quality milk. when a product is designated ‘‘pasteur- ized’’ or ‘‘ultra-pasteurized’’ every par- [58 FR 26913, May 6, 1993] ticle of the product shall be subjected § 58.141 Alternate quality control pro- to such temperatures and holding peri- gram. ods in approved systems as will assure proper pasteurization or ultra-pasteur- When a plant has in operation an ac- ization of the product. The heat treat- ceptable quality program, at the pro- ment by either process shall be suffi- ducer level, which is approved by the cient to insure public health safety and Administrator as being effective in ob- to assure adequate keeping quality, yet taining results comparable to or higher retaining the most desirable flavor and than the quality program as outlined body characteristics of the finished above for milk or cream, then such a product. program may be accepted in lieu of the program herein prescribed. § 58.145 Composition and wholesome- ness. OPERATIONS AND OPERATING All necessary precautions shall be PROCEDURES taken to prevent contamination or § 58.142 Product quality and stability. adulteration of the milk or dairy prod- ucts during manufacturing. All sub- The receiving, holding and processing stances and ingredients used in the of milk and cream and the manufac- processing or manufacturing of any turing, handling, packaging, storing dairy product shall be subject to in- and delivery of dairy products shall be spection and shall be wholesome and in accordance with clean and sanitary practically free from impurities. The methods, consistent with good com- finished products shall comply with the mercial practices to promote the pro- requirements of the Federal Food, duction of the highest quality of fin- Drug, and Cosmetic Act as to their ished product and improve product sta- composition and wholesomeness. bility. Milk should not be more than three days old when picked up from the § 58.146 Cleaning and sanitizing treat- producer and delivered to the plant, re- ment. ceiving station or transfer station. (a) Equipment and utensils. The equip- ment, sanitary piping and utensils used § 58.143 Raw product storage. in receiving and processing of the milk, (a) All milk shall be held and proc- and manufacturing and handling of the essed under conditions and at tempera- product shall be maintained in a sani- tures that will avoid contamination tary condition. Sanitary seal assem- and rapid deterioration. Drip milk blies shall be removable on all agi- from can washers and any other source tators, pumps, and vats and shall be in- shall not be used for the manufacture spected at regular intervals and kept of dairy products. Bulk milk in storage clean. Unless other provisions are rec- tanks within the dairy plant shall be ommended in the following supplement handled in such a manner as to mini- sections, all equipment not designed mize bacterial increase and shall be for C.I.P. cleaning or mechanical clean- maintained at 45 °F. or lower until ing shall be disassembled after each processing begins. This does not pre- day’s use for thorough cleaning. Dairy clude holding milk at higher tempera- cleaners, detergents, wetting agents or tures for a period of time, where appli- sanitizing agents, or other similar ma- cable to particular manufacturing or terials which will not contaminate or processing practices. adversely affect the products may be
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used. Steel wool or metal sponges shall Washers shall be maintained in a clean not be used in the cleaning of any dairy and satisfactory operating condition equipment or utensils. and kept free from accumulation of (1) Product contact surfaces shall be scale or debris which will adversely af- subjected to an effective sanitizing fect the efficiency of the washer. Only treatment prior to use, except where washing compounds which are compat- dry cleaning is permitted. Utensils and ible with the water for effective clean- portable equipment used in processing ing, should be used. The can washer and manufacturing operations shall be should be checked regularly during the stored above the floor in clean, dry lo- run for proper operation. At the end of cations and in a self draining position the day, the wash and rinse tanks on racks constructed of impervious should be drained and cleaned, jets and corrosion-resistant material. strainers cleaned, air filters checked (2) C.I.P. cleaning or mechanical cleaning systems shall be used only on and changed or cleaned if needed, and equipment and pipeline systems which checks should be made for proper ad- have been designed, engineered and in- justment and condition of mechanical stalled for that purpose. When such parts. cleaning is used, careful attention shall (c) Milk transport tanks. A covered or be given to the proper procedures to as- enclosed wash dock and cleaning and sure satisfactory cleaning. All C.I.P. sanitizing facilities shall be available installations and cleaning procedures to all plants that receive or ship milk shall be in accordance with 3–A Sug- in tanks. Milk transport tanks, sani- gested Method for the Installation and tary piping, fittings, and pumps shall Cleaning of Cleaned-In-Place Sanitary be cleaned and sanitized at least once Milk Pipelines for Milk and Milk Prod- each day after use: Provided that, if ucts Plants. Because of the possibili- they are not to be used immediately ties of corrosion, the recommendations after emptying a load of milk, they of the cleaning compound manufac- shall be washed promptly after use and turer should be followed with respect given bactericidal treatment imme- to time, temperature and concentra- diately before use. After being washed tion of specific acid or alkaline solu- and sanitized, each tank should be tions and bactericides. Such cleaning identified by a tag attached to the out- operation should be preceded by a thor- let valve, bearing the following infor- ough rinse at approximately 110–115 °F. mation: Plant and specific location continuously discarding the water. Fol- where cleaned, date and time of day of lowing the circulation of the cleaning solution the equipment and lines shall washing and sanitizing, and name of be thoroughly rinsed with lukewarm person who washed and name of person water and checks should be made for who sanitized the tank. The tag shall effectiveness of cleaning. All caps, not be removed until the tank is again plugs, special fittings, valve seats, washed and sanitized. cross ends, pumps, and tee ends shall (d) Building. All windows, glass, par- be opened or removed and brushed titions, and skylights should be washed clean. All non-pasteurized product con- as often as necessary to keep them tact surfaces should be sanitized. Im- clean. Cracked or broken glass shall be mediately prior to starting the product replaced promptly. The walls, ceilings flow, the pasteurized product contact and doors should be washed periodi- surfaces shall be given sanitizing treat- cally and kept free from soil and un- ment. sightly conditions. The shelves and (b) Milk cans and can washers. Milk ledges should be wiped or vacuumed as cans and lids shall be cleaned, sanitized often as necessary to keep them free and dried before returning to pro- from dust and debris. The material ducers. Inspection, repair or replace- picked up by the vacuum cleaners shall ment of cans and lids shall be adequate be disposed of in sealed containers to substantially exclude from use cans which will prevent contamination or and lids showing open seams, cracks, insect infestation from the waste mate- rust condition, milkstone or any un- rial. sanitary condition.
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§ 58.147 Insect and rodent control pro- (g) Somatic cell count test results on gram. raw milk from each producer. Retain for 12 months. In addition to any commercial pest control service, if one is utilized, a spe- (Approved by the Office of Management and cially designated employee should be Budget under OMB control number 0583– 1 made responsible for the performance 0047) of a regularly scheduled insect and ro- [40 FR 47911, Oct. 10, 1975. Redesignated at 42 dent control program. Poisonous sub- FR 32514, June 27, 1977, and further redesig- nated at 46 FR 63203, Dec. 31, 1981, as amend- stances shall be properly labeled, and ed at 47 FR 745, Jan. 7, 1982; 58 FR 26913, May shall be handled, stored and used in 6, 1993] such a manner as considered satisfac- tory by the Environmental Protection § 58.149 Alternate quality control pro- Agency. grams for dairy products. (a) When a plant has in operation an § 58.148 Plant records. acceptable quality control program Adequate plant records shall be which is approved by the Adminis- maintained of all required tests and trator as being effective in obtaining analyses performed in the laboratory results comparable to or higher than the quality control program as out- or throughout the plant during storage, lined in this subpart, then such a pro- processing and manufacturing, on all gram may be accepted in lieu of the raw milk receipts and dairy products. program herein prescribed. Such records shall be available for ex- (b) Where a minimum number of amination at all reasonable times by samples per batch of product, or per the inspector. The following are the unit of time on continuous production records which shall be maintained for runs are not specified, the phrase ‘‘as examination at the plant or receiving many samples shall be taken as is nec- station where performed. essary to assure compliance to specific (a) Sediment and bacterial test re- quality requirements’’ is used. Accept- sults on raw milk from each producer. able performance of this would be any Retain for 12 months. method approved by the Administrator (1) Routine tests and monthly sum- as meeting sound statistical methods mary of all producers showing number of selecting samples and determining and percent of total in each class. the number of samples to be taken. (2) Retests, if initial test places milk PACKAGING AND GENERAL in probationary status. IDENTIFICATION (3) Rejections of raw milk over No. 3 in quality. § 58.150 Containers. (b) Pasteurization recorder charts. (a) The size, style, and type of pack- Retain for 3 months. aging used for dairy products shall be (c) Water supply test certificate. Re- commercially acceptable containers tain current copy for 6 months. and packaging materials which will (d) Cooling and heating recorder satisfactorily cover and protect the charts. Retain for 3 months. quality of the contents during storage (e) Load and individual drug residue and regular channels of trade and test results. Retain for 12 months. under normal conditions of handling. (f) Notifications to appropriate State (b) Packaging materials for dairy products shall be selected which will regulatory agencies of positive drug provide sufficiently low permeability residue tests and intended and final dispositions of milk testing positive for 1 drug residue. Retain for 12 months. EDITORIAL NOTE: See table appearing in § 58.100 for correct OMB control number.
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to air and vapor to prevent the forma- storage of any other product foreign to tion of mold growth and surface oxida- dairy products in the same room, in tion. In addition, the wrapper should be order to prevent impairment or damage resistant to puncturing, tearing, crack- to the dairy product from mold, ab- ing or breaking under normal condi- sorbed odors, or vermin or insect infes- tions of handling, shipping and storage. tation. Control of humidity and tem- When special type packaging is used, perature shall be maintained at all the instructions of the manufacturer times, consistent with good commer- shall be followed closely as to its appli- cial practices, to prevent conditions cation and methods of closure. detrimental to the product and con- tainer. § 58.151 Packaging and repackaging. (a) Packaging dairy products or cut- § 58.154 Refrigerated storage. ting and repackaging all styles of dairy Finished product in containers sub- products shall be conducted under rigid ject to such conditions that will affect sanitary conditions. The atmosphere of its useability shall be placed on the packaging rooms, the equipment shelves, dunnage or pallets and prop- and packaging materials shall be prac- erly identified. It shall be stored under tically free from mold and bacterial temperatures that will best maintain contamination. Methods for checking the initial quality. The product shall the level of contamination shall be as not be exposed to anything from which prescribed by the latest edition of it might absorb any foreign odors or be Standard Methods or by other satisfac- contaminated by drippage or condensa- tory methods approved by the Adminis- tion. trator. (b) When officially graded bulk dairy INSPECTION, GRADING AND OFFICIAL products are to be repackaged into con- IDENTIFICATION sumer type packages with official grade labels or other official identifica- § 58.155 Grading. tion, a supervisor of packaging shall be Dairy products which have been proc- required, see subpart A of this part. essed or manufactured in accordance (title 7, §§ 58.2 and 58.53 of the Code of with the provisions of this subpart may Federal Regulations). If the packaging be graded by the grader in accordance or repackaging is done in a plant other with the U.S. Standards for Grades. than the one in which the dairy prod- Laboratory analyses, when required in uct is manufactured, the plant, equip- determining the final grade shall be ment, facilities and personnel shall conducted in an approved laboratory. meet the same requirements as out- lined in this subpart. § 58.156 Inspection. Dairy products, which have been § 58.152 General identification. processed or manufactured in an ap- All commercial bulk packages or proved plant, and for which there are consumer packaged product containing no official U.S. Standards for Grades, dairy products manufactured under the shall be inspected for quality by the in- provisions of this subpart shall comply spector in accordance with contract re- with the applicable regulation of the quirements or product specifications Food and Drug Administration. established by the U.S. Department of Agriculture or other Federal agency or STORAGE OF FINISHED PRODUCT buyer and seller. Laboratory analysis when required shall be conducted in an § 58.153 Dry storage. approved laboratory. The product should be stored at least 18 inches from the wall in aisles, rows, § 58.157 Inspection or grading certifi- or sections and lots, in such a manner cates. as to be orderly and easily accessible All dairy products which have been for inspection. Rooms should be processed or manufactured, packaged cleaned regularly. It is recommended and inspected or graded in accordance that dunnage or pallets be used when with the provision of this part may be practical. Care shall be taken in the covered by an inspection or grading
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certificate issued by the inspector or SUPPLEMENTAL SPECIFICATIONS FOR grader. PLANTS MANUFACTURING, PROCESSING, AND PACKAGING NONFAT DRY MILK, § 58.158 Official identification. INSTANT NONFAT DRY MILK, DRY (a) Application for authority to apply WHOLE MILK, AND DRY BUTTERMILK official identification to packaging ma- DEFINITIONS terial or containers shall be made in accordance with the provisions of sub- § 58.205 Meaning of words. part A of this part. (title 7, §§ 58.49 For the purpose of the regulations in through 58.57 of the Code of Federal this subpart, words in the singular Regulations.) form shall be deemed to impart the (b) Only dairy products received, plural and vice versa, as the case may processed, or manufactured in accord- demand. Unless the context otherwise ance with the specifications contained requires, the following terms shall in this subpart and inspected and/or have the following meaning: graded in accordance with the provi- (a) Nonfat dry milk. The product ob- sions of this part may be identified tained by the removal of only water with official identification. from pasteurized skim milk. It con- tains not more than 5 percent by EXPLANATION OF TERMS weight of moisture and not more than 11⁄2 percent by weight of milkfat and it § 58.159 Terms. conforms to the applicable provisions (a) Fresh and sweet. Free from ‘‘old of 21 CFR 131 ‘‘Milk and Cream’’ as milk’’ flavor of developed acidity or issued by the Food and Drug Adminis- other off-flavors. tration. Nonfat dry milk shall not con- (b) Normal feed. Regional feed flavors, tain nor be derived from dry butter- such as alfalfa, clover, silage, or simi- milk, dry whey, or products other than lar feeds or grasses (weed flavors, such skim milk, and shall not contain any as peppergrass, French weed, onion, added preservative, neutralizing agent, garlic, or other obnoxious weeds, ex- or other chemical. cluded). (b) Instant nonfat dry milk. Instant (c) Off-flavors. Tastes or odors, such nonfat dry milk is nonfat dry milk as utensil, bitter, barny, or other asso- which has been produced in such a ciated defects when present to a degree manner as to substantially improve its readily detectable. dispersing and reconstitution charac- (d) Developed acidity. An apparent in- teristics over that produced by the con- crease from the normal acidity of the ventional process. Instant nonfat dry milk to a degree of taste and odor milk shall not contain dry buttermilk, which is detectable. dry whey, or products other than non- fat dry milk, except that lactose may (e) Extraneous matter. Foreign sub- be added as a processing aid during stances, such as filth, hair, insects and instantizing. The instant nonfat dry fragments thereof, and rodents, and milk shall not contain any added pre- materials, such as metal, fiber, wood servatives, neutralizing agent, or other and glass. chemical. If lactose is used, the (f) Sediment. Fine particles of mate- amount of lactose shall be the min- rial other than the foreign substances imum required to produce the desired and materials defined in paragraph (e) effect, but in no case shall the amount of this section. exceed 2.0 percent of the weight of the (g) C.I.P. The abbreviation of an ap- nonfat dry milk. If instant nonfat dry proved system of cleaning pipelines milk is fortified with vitamin A, and called ‘‘Cleaned-in-Place.’’ the product is reconstituted in accord- (h) Mechanical cleaning. Denotes ance with the label directions, each cleaning solely by circulation and/or quart of the reconstituted product flowing chemical detergent solution shall contain 2000 International Units and water rinses onto and over the sur- thereof. If instant nonfat dry milk is faces to be cleaned, by mechanical fortified with vitamin D, and the prod- means. uct is reconstituted in accordance with
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the label directions, each quart of the sible false areas which may harbor in- reconstituted product shall contain 400 sects. International Units thereof. (c) Dry whole milk. The pasteurized § 58.211 Packaging room for bulk prod- product resulting from the removal of ucts. water from milk and contains the lac- A separate room or area shall be pro- tose, milk proteins, milk fat, and milk vided for filling bulk containers, and minerals in the same relative propor- shall be constructed in accordance with tions as in the fresh milk from which § 58.126. The number of control panels made. The milk may be standardized and switch boxes in this area should be but shall not contain buttermilk, or kept to a minimum. Control panels any added preservative, neutralizing shall be mounted a sufficient distance agent or other chemicals. from the walls to facilitate cleaning or (d) Dry buttermilk. The product result- satisfactorily sealed to the wall, or ing from drying liquid buttermilk that shall be mounted in the wall and pro- was derived from the churning of but- ter and pasteurized prior to condensing vided with tight fitting removable at a temperature of 161 °F for 15 sec- doors to facilitate cleaning. An ade- onds or its equivalent in bacterial de- quate exhaust system shall be provided struction. Dry buttermilk shall have a to minimize the accumulation of prod- protein content of not less than 30.0 uct dust within the packaging room percent. Dry buttermilk shall not con- and where needed, a dust collector tain nor be derived from nonfat dry shall be provided and properly main- milk, dry whey, or products other than tained to keep roofs and outside areas buttermilk, and shall not contain any free of dry product. Only packaging added preservative, neutralizing agent, materials that are used within a day’s or other chemical. operation may be kept in the pack- (e) Dry buttermilk product. The prod- aging area. These materials shall be uct resulting from drying liquid butter- kept on metal racks or tables at least milk that was derived from the churn- six inches off the floor. Unnecessary ing of butter and pasteurized prior to fixtures, equipment, or false areas condensing at a temperature of 161 °F which may collect dust and harbor in- for 15 seconds or its equivalent in bac- sects, should not be allowed in the terial destruction. Dry buttermilk packaging room. product has a protein content less than 30.0 percent. Dry buttermilk product § 58.212 Hopper or dump room. shall not contain nor be derived from A separate room shall be provided for nonfat dry milk, dry whey, or products other than buttermilk, and shall not the transfer of bulk dry dairy products contain any added preservative, neu- to the hoppers and conveyors which tralizing agent, or other chemical. lead to the fillers. This room shall meet the same requirements for con- [40 FR 47911, Oct. 10, 1975. Redesignated at 42 struction and facilities as the bulk FR 32514, June 27, 1977, and further redesig- packaging operation. Areas and facili- nated at 46 FR 63203, Dec. 31, 1981, as amend- ed at 56 FR 33855, July 24, 1991; 61 FR 17548, ties provided for the transfer of dry Apr. 22, 1996; 61 FR 35590, July 8, 1996] dairy products from portable bulk bins will be accepted if gasketed surfaces or ROOMS AND COMPARTMENTS direct connections are used that appre- ciably eliminate the escape of product § 58.210 Dry storage of product. into the area. Storage rooms for the dry storage of product shall be adequate in size, kept § 58.213 Repackaging room. clean, orderly, free from rodents, in- A separate room shall be provided for sects, and mold, and maintained in the filling of small packages and shall good repair. They shall be adequately meet the same requirements for con- lighted and ventilated. The ceilings, struction and facilities as the bulk walls, beams and floors should be free packaging operation. from structural defects and inacces-
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EQUIPMENT AND UTENSILS foam being held in the surge tank dur- ing processing, is not maintained at a § 58.214 General construction, repair minimum of 150 °F, then two or more and installation. surge tanks shall be installed with All equipment and utensils necessary cross connections to permit flushing to the manufacture of dry milk prod- and cleaning during operation. Covers ucts, including pasteurizer, timing- easily removable for cleaning shall be pump or device, flow diversion valve provided and used at all times. and recorder controller, shall meet the same general requirements as outlined § 58.219 High pressure pumps and in § 58.128 of this subpart. In addition, lines. for certain other equipment the fol- lowing requirements shall be met. High pressure lines may be cleaned- in-place and shall be of such construc- § 58.215 Pre-heaters. tion that dead ends, valves and the The pre-heaters shall be of stainless high pressure pumps can be disassem- steel or other equally corrosion resist- bled for hand cleaning. The high pres- ant material, cleanable, accessible for sure pump shall comply with the 3–A inspection and shall be equipped with Sanitary Standard for Homogenizers suitable automatic temperature con- and Pumps of the Plunger Type. trols. § 58.220 Drying systems. § 58.216 Hotwells. (a) Spray dryers. Spray dryers shall be The hotwells shall be enclosed or cov- of a continuous discharge type and all ered and should be equipped with indi- product contact surfaces shall be of cating thermometers either in the stainless steel or other equally corro- hotwell or in the hot milk inlet line to sion resistant material. All joints and the hotwell. If used for holding high seams in the product contact surfaces heat products, they should also have shall be welded and ground smooth. All recorders. dryers shall be constructed so as to fa- cilitate ease in cleaning and inspec- § 58.217 Evaporators and/or vacuum pans. tion. Sight glasses or ports of sufficient size shall be located at strategic posi- Evaporators or vacuum pans or both, tions. Dryers shall be equipped with with open type condensers shall be suitable air intake filters. The filter equipped with an automatic condenser system shall comply with the applica- water level control, barometric leg, or ble requirements of the 3–A Accepted so constructed so as to prevent water Practices for Milk and Milk Products from entering the product. New or re- placement units shall comply with the Spray Drying Systems. The filtering 3–A Sanitary Standards for Milk and system shall be cleaned or component Milk Products Evaporators and Vacu- parts replaced as often as necessary to um Pans. When enclosed type con- maintain a clean and adequate air sup- densers are used, no special controls ply. In gas fired dryers, precautions are needed to prevent water from en- should be taken to assure complete tering the product. Water collected combustion. Air shall be drawn into from the condensing of product (cow the dryer from sources free from objec- water) in this equipment may be uti- tionable odors and smoke, dust or dirt. lized for prerinsing and cleaning solu- New systems, replacement systems, or tion make-up; provided it is equipped portions of systems replaced shall com- with proper controls that will auto- ply with the requirements of the 3–A matically divert water with entrained Accepted Practices for Milk and Milk solids to the waste water system. ‘‘Cow Products Spray Drying Systems. water’’ shall not be used for acidified (b) Roller dryers. (1) The drums of a or final equipment rinse. roller dryer shall be smooth, readily cleanable and free of pits and rust. The § 58.218 Surge tanks. knives shall be maintained in such con- If surge tanks are used for hot milk, dition so as not to cause scoring of the and temperatures of product including drums.
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(2) The end boards shall have an im- able dry air supply with an effective pervious surface and be readily clean- filtering system meeting the require- able. They shall be provided with a ments of § 58.220(a) shall be provided means of adjustment to prevent leak- where air cooling and conveying is age and accumulation of milk solids. used. The stack, hood, the drip pan inside of the hood and related shields shall be § 58.223 Special treatment equipment. constructed of stainless steel and be Any special equipment (instantizers, readily cleanable. The lower edge of hammer mills, etc.) used to treat dry the hood shall be constructed so as to milk products shall be of sanitary con- prevent condensate from entering the struction and all parts shall be acces- product zone. The hood shall be prop- sible for cleaning and inspection. New erly located and the stack of adequate or replacement instantizing systems capacity to remove the vapors. The shall comply with the 3–A Accepted stack shall be closed when the dryer is Practices for Instantizing Systems for not in operation. The augers shall be Dry Milk and Dry Milk Products. stainless steel or properly plated, and readily cleanable. The auger troughs § 58.224 Sifters. and related shields shall be of stainless All newly installed sifters used for steel and be readily cleanable. All air dry milk and dry milk products shall entering the dryer room shall be fil- comply with the 3–A Sanitary Stand- tered to eliminate dust and dirt. The ards for Sifters for Dry Milk and Dry filter system shall consist of filtering Milk Products. All other sifters shall media or device that will effectively, be constructed of stainless steel or and in accordance with good commer- other equally noncorrosive material cial practices, prevent the entrance of and shall be of sanitary construction foreign substances into the drying and accessible for cleaning and inspec- room. The filtering system shall be tion. The mesh size of sifter screen cleaned or component parts replaced as used for various dry dairy products often as necessary to maintain a clean shall be those recommended in the ap- and adequate air supply. All dryer ad- pendix of the 3–A Standard for sifters. justments shall be made and the dryer operating normally before food grade § 58.225 Clothing and shoe covers. product is collected from the dryer. Clean clothing and shoe covers shall (c) Other drying systems. These sys- be provided exclusively for the purpose tems shall be constructed following the of cleaning the interior of the dryer applicable principles of the 3–A Accept- when it is necessary to enter the dryer ed Practices for Milk and Milk Prod- to perform the cleaning operation. ucts Spray Drying Systems. § 58.226 Portable and stationary bulk § 58.221 Collectors and conveyors. bins. Collectors shall be made of stainless Bulk bins shall be constructed of steel or equally noncorrosive material stainless steel, aluminum or other and should be constructed to facilitate equally corrosion resistant materials, cleaning and inspection. Filter sack free from cracks, seams and must have collectors, if used, shall be in good con- an interior surface that is relatively dition and the system shall be of such smooth and easily cleanable. All prod- construction that all parts are acces- uct contact surfaces shall be easily ac- sible for cleaning and inspection. Con- cessible for cleaning. The capacity of veyors shall be of stainless steel or each portable and bulk bin shall be equally corrosion resistant material limited to permit proper operating pro- and should be constructed to facilitate cedures such as sampling and daily re- thorough cleaning and inspection. moval of all product to preclude com- mingling of different days production. § 58.222 Dry dairy product cooling equipment. § 58.227 Sampling device. Cooling equipment shall be provided If automatic sampling devices are with sufficient capacity to cool the used, they shall be constructed in such product as specified in § 58.240. A suit- a manner as to prevent contamination
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of the product, and all parts must be cooled to and held at a temperature of readily accessible for cleaning. The 45 °F. or lower until processed. type of sampler and the sampling pro- cedure shall be as approved by the Ad- § 58.233 Skim milk. ministrator. The skim milk shall be separated from whole milk meeting the require- § 58.228 Dump hoppers, screens, mix- ments as outlined in §§ 58.132 through ers and conveyors. 58.138, and unless processed imme- The product contact surfaces of dump diately, it shall be cooled to and main- hoppers, screens, mixers and conveyors tained at a temperature of 45 °F. or which are used in the process of trans- lower from the time of separating until ferring dry products from bulk con- the time of processing. tainers to fillers for small packages or containers, shall be of stainless or § 58.234 Buttermilk. equally corrosion resistant material Buttermilk for drying as dry butter- and designed to prevent contamina- milk or dry buttermilk product shall tion. All parts should be accessible for be fresh and derived from the churning cleaning. The dump hoppers shall be of of butter, with or without the addition such height above floor level as to pre- of harmless lactic culture. No preserva- vent foreign material or spilled prod- tive, neutralizing agent or other chem- uct from entering the hopper. ical may be added. Fluid buttermilk, unless cultured, shall be held at 45 °F § 58.229 Filler and packaging equip- or lower unless processed within 2 ment. hours. All filling and packaging equipment [56 FR 33855, July 24, 1991] shall be of sanitary construction and all parts, including valves and filler § 58.235 Modified dry milk products. heads accessible for cleaning. New or Dry milk products to which approved replacement equipment should comply neutralizing agents or chemicals have with the 3–A Sanitary Standards for been added or constituents removed to equipment for Packaging Dry Milk and alter their original characteristics for Dry Milk Products. processing or usage shall come from products meeting the requirements of § 58.230 Heavy duty vacuum cleaners. §§ 58.232, 58.233, or 58.234. These products Each plant handling dry milk prod- shall meet the applicable labeling re- ucts shall be equipped with a heavy quirements. duty industrial vacuum cleaner. The OPERATIONS AND OPERATING vacuum cleaner shall be of a type that PROCEDURES has a collector or disposable bag which will not recontaminate the atmosphere § 58.236 Pasteurization and heat treat- of the processing and packaging areas. ment. Regular scheduling shall be established All milk and buttermilk used in the for its use in vacuuming applicable manufacture of dry milk products and areas. modified dry milk products shall be pasteurized at the plant where dried, QUALITY SPECIFICATIONS FOR RAW except that acidified buttermilk con- MATERIALS taining 40 percent or more solids may § 58.231 General. be transported to another plant for drying without repasteurization. Pro- All raw materials received at the vided the condensed product is handled drying plant shall meet the following according to sanitary conditions ap- quality specifications. proved by the Administrator. (a) Pasteurization. (1) All milk or § 58.232 Milk. skim milk to be used in the manufac- Raw milk shall meet the require- ture of nonfat dry milk shall be pas- ments as outlined in §§ 58.132 through teurized prior to condensing at a min- 58.138 and, unless processed within two imum temperature of 161 °F. for at hours after being received, it shall be least 15 seconds or its equivalent in
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bacterial destruction. Condensed milk (b) Product cut-off points shall be products made from pasteurized milk made at least every 24 hours and the may be transported to a drying plant, tank completely emptied, washed, and provided that it shall be effectively re- sanitized before reuse. pasteurized at the drying plant, prior to drying, at no less than 166 °F. for 15 § 58.239 Drying. seconds or its equivalent in bacterial Each dryer should be operated to destruction. produce the highest quality dry prod- (2) All buttermilk to be used in the uct consistent with the most efficient manufacture of dry buttermilk or dry operation. The dry products shall be re- buttermilk product shall be pasteur- moved from the drying chamber con- ized prior to condensing at a tempera- tinuously during the drying process. ture of 161 °F for 15 seconds or its equivalent in bacterial destruction. § 58.240 Cooling dry products. (b) Heat treatment—(1) High-heat. The Prior to packaging and immediately finished product shall not exceed 1.5 following removal from the drying mg. undenatured whey protein nitro- chamber the dry product shall be gen per gram of nonfat dry milk as cooled to a temperature not exceeding classified in the U.S. Standards for ° Grades of Nonfat Dry Milk (Spray 110 F, however, if the product is to be Process). held in a bulk bin the temperature should be reduced to approximately 90 (2) Medium-heat. The finished product °F but shall be not more than 110 °F. shall show undenatured whey protein nitrogen between the levels of ‘‘high- § 58.241 Packaging, repackaging and heat’’ and ‘‘low-heat’’ (1.51 to 5.99 mg.). storage. (3) Low-heat. The finished product shall show not less than 6.0 (a) Containers. Packages or con- undenatured whey protein nitrogen per tainers used for the packaging of non- gram of non-fat dry milk as classified fat dry milk or other dry milk products in the U.S. Standards for Grades of shall be any clean, sound commercially Nonfat Dry Milk (Spray Process). accepted container or packaging mate- rial which will satisfactorily protect [40 FR 47911, Oct. 10, 1975. Redesignated at 42 the contents through the regular chan- FR 32514, June 27, 1977, and further redesig- nels of trade, without significant im- nated at 46 FR 63203, Dec. 31, 1981, as amend- pairment of quality with respect to fla- ed at 56 FR 33855, July 24, 1991] vor, wholesomeness or moisture con- tent under the normal conditions of § 58.237 Condensed surge supply. handling. In no instance will con- Surge tanks or balance tanks if used tainers which have previously been between the evaporators and dryer used for nonfood items, or food items shall be used to hold only the min- which would be deleterious to the dairy imum amount of condensed product product be allowed to be used for the necessary for a uniform flow to the bulk handling of dairy products. dryers. Such tanks holding product at (b) Filling. Empty containers shall be temperatures below 150 °F. shall be protected at all times from possible completely emptied and washed after contamination and containers which each 4 hours of operation or less. Alter- are to be lined shall not be prepared nate tanks shall be provided to permit more than one hour in advance of fill- continuous operation during washing ing. Every precaution shall be taken of tanks. during the filling operation to mini- mize product dust and spillage. When § 58.238 Condensed storage tanks. necessary a mechanical shaker shall be (a) Excess production of condensed provided; the tapping or pounding of product over that which the dryer will containers should be prohibited. The take continuously from the pans containers shall be closed immediately should be bypassed through a cooler after filling and the exteriors shall be into a storage tank at 50 °F. or lower vacuumed or brushed when necessary and held at this temperature until to render them practically free of re- used. sidual product before being transferred
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from the filling room to the palleting area separate from that used for stor- or dry storage areas. ing the dry products. Supplies shall be (c) Repackaging. The entire repack- kept enclosed in their original wrap- aging operation shall be conducted in a ping material until used. After removal sanitary manner with all precautions of supplies from their original con- taken to prevent contamination and to tainers, they shall be kept in an en- minimize dust. All exterior surfaces of closed metal cabinet, bins or on shelv- individual containers shall be prac- ing and if not enclosed shall be pro- tically free of product before overwrap- tected from powder, and dust or other ping or packing in shipping containers. contamination. The room should be The room shall be kept free of dust ac- vacuumed as often as necessary and cumulation, waste, cartons, liners, or kept clean and orderly. other refuse. Conveyors, packaging and carton making equipment shall be § 58.242 Product adulteration. vacuumed frequently during the oper- All necessary precautions shall be ating day to prevent the accumulation taken throughout the entire operation of dust. No bottles or glass materials of to prevent the adulteration of one any kind shall be permitted in the re- product with another. The commin- packaging or hopper room. The inlet gling of one type of liquid or dry prod- openings of all hoppers and bins shall uct with another shall be considered as be of minimum size, screened and an adulteration of that product. This placed well above the floor level. The does not prohibit the normal standard- room and all packaging equipment ization of like products in accordance shall be cleaned as often as necessary with good commercial practices or the to maintain a sanitary operation. Close production of specific products for spe- attention shall be given to cleaning cial uses, provided applicable labeling equipment where residues of the dry requirements are met. product may accumulate. A thorough clean-up including windows, doors, § 58.243 Checking quality. walls, light fixtures and ledges, should All milk, milk products and dry milk be performed as frequently as is nec- products shall be subject to inspection essary to maintain a high standard of and analysis by the dairy plant for cleanliness and sanitation. All waste quality and condition throughout each dry dairy products including dribble processing operation. Periodically sam- product at the fillers, shall be properly ples of product and environmental ma- identified and disposed of as animal terial shall be tested for salmonella. feed. Test results shall be negative when (d) Storage—(1) Product. The packaged samples are tested for salmonella. Line dry milk product shall be stored or so samples should be taken periodically arranged in aisles, rows, or sections as an aid to quality control in addition and lots at least 18 inches from any to the regular routine analysis made wall and in such a manner as to be or- on the finished products. derly, easily accessible for inspection or for cleaning of the room. All bags § 58.244 Number of samples. and small containers of products shall As many samples shall be taken from be placed on pallets elevated from the each dryer production lot as is nec- floor. Products in small containers essary to assure proper composition may be stored by methods preventing and quality control. A sufficient num- direct contact with the floor when the ber of representative samples from the condition of the container is satisfac- lot shall be taken to assure compliance torily maintained. The storage room with the stated net weight on the con- shall be kept clean and dry and all tainer. openings protected against entrance of insects and rodents. § 58.245 Method of official sample anal- (2) Supplies. All supplies shall be ysis. placed on dunnage or pallets and ar- Samples shall be tested according to ranged in an orderly manner for acces- the applicable methods of laboratory sibility and cleaning of the room. It is analysis contained in DA Instruction preferable that supplies be stored in an 918–103, 918–109–1 and 918–109–3 as issued
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by the USDA, Agricultural Marketing § 58.250 Dry whole milk. Service, Dairy Division. Dry whole milk in commercial bulk § 58.246 Cleaning of dryers, collectors, containers which bears an official iden- conveyors, ducts, sifters and stor- tification shall meet the requirements age bins. for the U.S. Standards for Grades of Dry Whole Milk. Quality requirements This equipment shall be cleaned as for dry whole milk in consumer pack- often as is necessary to maintain such ages shall be for U.S. Extra Grade and equipment in a clean and sanitary con- shall be gas packed with an oxygen dition. The kind of cleaning procedure content of not more than 2.0 percent. either wet or dry and the frequency of cleaning shall be based upon observa- § 58.251 Dry buttermilk and dry but- tion of actual operating results and termilk product. conditions. The quality requirements for dry § 58.247 Insect and rodent control pro- buttermilk or dry buttermilk product gram. bearing an official identification shall be in accordance with the U.S. Stand- In addition to any commercial pest ards for Grades of Dry Buttermilk and control service, if one is utilized, a spe- Dry Buttermilk Product. cially designated employee should be made responsible for the performance [56 FR 33855, July 24, 1991] of a regularly scheduled insect and ro- dent control program as outlined in SUPPLEMENTAL SPECIFICATIONS FOR University of Wisconsin Extension Bul- PLANTS MANUFACTURING, PROCESSING letin A2518 or subsequent revisions AND PACKAGING BUTTER AND RELATED thereof, or one equivalent thereto. PRODUCTS DEFINITIONS REQUIREMENTS FOR FINISHED PRODUCTS BEARING USDA OFFICIAL IDENTIFICA- § 58.305 Meaning of words. TION For the purpose of the regulations in § 58.248 Nonfat dry milk. this subpart, words in the singular (a) Nonfat dry milk in commercial form shall be deemed to impart the bulk containers bearing an official plural and vice versa, as the case may identification shall meet the require- demand. Unless the context otherwise ments of U.S. Extra Grade or U.S. requires, the following terms shall Standard Grade. have the following meaning. (b) Regular nonfat dry milk in con- (a) Butter. The food product usually sumer size packages which bears an of- known as butter, and which is made ex- ficial identification shall meet the re- clusively from milk or cream, or both, quirements of U.S. Extra Grade. In ad- with or without common salt, with or dition, the nonfat dry milk shall be without additional coloring matter, sampled and tested in accordance with and containing not less than 80 percent §§ 58.244 and 58.245. by weight of milkfat, all tolerances having been allowed for. § 58.249 Instant nonfat dry milk. (b) Butteroil. The food product result- ing from the removal of practically all (a) Only instant nonfat dry milk of the moisture and solids-not-fat from manufactured and packaged in accord- butter. It contains not less than 99.6 ance with the requirements of this part percent fat and not more than 0.3 per- and with the applicable requirements cent moisture and not more than 0.1 in subpart A of this part which has percent other butter constituents, of been officially inspected in process and which the salt shall be not more than found to be in compliance with these 0.05 percent. Antioxidants permitted to requirements may be identified with be used are as follows: the official USDA U.S. Extra Grade, processed and packed inspection shield. Antioxidant Maximum level (b) Instant nonfat dry milk shall Propyl gallate ...... 0.02% of fat. meet the applicable standard for U.S. Butylated hydroxytoluene (BHT) ..... 0.02% of fat. Extra Grade. Butylated hydroxyanisole (BHA) ..... 0.02% of fat.
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Antioxidant Maximum level tion of air shall be maintained at all times. The floors, walls, and ceilings Tocopherols ...... Limit by GMP. Ascorbyl palmitate ...... Limit by GMP. shall be of such construction as to per- Dilauryl thiodipropionate ...... 0.02% of fat. mit thorough cleaning. Antioxidant synergists Citric acid ...... Limit by GMP. § 58.312 Churn rooms. Sodium citrate ...... Limit by GMP. Isopropyl citrate ...... 0.02% of food. Churn rooms in addition to proper Phosphoric acid ...... Limit by GMP. construction and sanitation shall be so Monoglyceride citrate ...... 200 ppm of fat. equipped that the air is kept free from objectionable odors and vapors and ex- An inert gas may be used to flush air- treme temperatures by means of ade- tight containers before, during, and quate ventilation and exhaust systems after filling. Carbon dioxide may not be or air conditioning and heating facili- used for this purpose. ties. (c) Anhydrous milkfat. The food prod- uct resulting from the removal of prac- § 58.313 Print and bulk packaging tically all of the moisture and solids- rooms. not-fat from pasteurized cream or but- Rooms used for packaging print or ter. It contains not less than 99.8 per- bulk butter and related products cent fat and not more than 0.1 percent should, in addition to proper construc- moisture and, when produced from but- tion and sanitation, provide an atmos- ter, not more than 0.1 percent other phere relatively free from mold (not butter constituents, of which the salt shall be not more than 0.05 percent. An more than 15 colonies per plate during inert gas may be used to flush air-tight a 15 min. exposure), dust, or other air- containers before, during, and after borne contamination and maintain a filling. Carbon dioxide may not be used reasonable room temperature in ac- for this purpose. cordance with good commercial prac- (d) Frozen cream. Sweet cream which tices. has been pasteurized and frozen. It con- EQUIPMENT AND UTENSILS tains approximately 40 percent milkfat. § 58.314 General construction, repair (e) Plastic cream. Sweet cream which and installation. has been pasteurized and contains ap- All equipment and utensils necessary proximately 80 percent milkfat. to the manufacture of butter and re- (f) Whipped butter. The food product lated products shall meet the same is made by the uniform incorporation general requirements as outlined in of air or inert gas into butter. § 58.128. In addition for certain other [40 FR 47911, Oct. 10, 1975. Redesignated at 42 equipment, the following requirements FR 32514, June 27, 1977, and further redesig- shall be met. nated at 46 FR 63203, Dec. 31, 1981, as amend- ed at 59 FR 1264, Jan. 10, 1994; 60 FR 4825, § 58.315 Continuous churns. Jan. 24, 1995] All product contact surfaces of the ROOMS AND COMPARTMENTS churn and related equipment shall be of noncorrosive material. All non-me- § 58.311 Coolers and freezers. tallic product contact surfaces shall The coolers and freezers shall be comply with 3–A Standards for Plastic, equipped with facilities for maintain- Rubber, and Rubber-Like Materials. ing proper temperature and humidity All product contact surfaces of the conditions, consistent with good com- churn and related equipment shall be mercial practices for the applicable readily accessible for cleaning and in- product, to protect the equality and spection. Construction shall follow the condition of the products during stor- applicable principles of the 3–A Sani- age or during tempering prior to fur- tary Standards. ther processing. Coolers and freezers shall be kept clean, orderly, free from § 58.316 Conventional churns. insects, rodents, and mold, and main- Churns shall be constructed of alu- tained in good repair. They shall be minum, stainless steel or equally cor- adequately lighted and proper circula- rosion resistant metal, free from
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cracks, and in good repair. All gasket QUALITY SPECIFICATIONS FOR RAW material shall be fat resistant, MATERIAL nontoxic and reasonably durable. Seals around the doors shall be tight. § 58.322 Cream. Cream separated at an approved § 58.317 Bulk butter trucks, boats, texturizers, and packers. plant and used for the manufacture of butter shall have been derived from Bulk butter trucks, boats, raw material meeting the requirements texturizers, and packers shall be con- as listed under §§ 58.132 through 58.138 structed of aluminum, stainless steel, of this subpart. or equally corrosion resistant metal free from cracks, seams and must have [50 FR 34673, Aug. 27, 1985] a surface that is relatively smooth and easily cleanable. All non-metallic prod- § 58.323 [Reserved] uct surfaces shall comply with 3–A Standards for Plastic, Rubber, and § 58.324 Butteroil. Rubber-Like Material. To produce butteroil eligible for offi- cial certification, the butter used shall § 58.318 Butter, frozen or plastic cream conform to the flavor requirements of melting machines. U.S. Grade AA, U.S. Grade A, or U.S. Shavers, shredders or melting ma- Grade B, and shall have been manufac- chines used for rapid melting of butter, tured in an approved plant. frozen or plastic cream shall be of stainless steel or equally corrosion re- § 58.325 Anhydrous milkfat. sistant metal, free from cracks and of If cream is used in the production of sanitary construction, and readily anhydrous milkfat that is eligible for cleanable. official certification, the anhydrous § 58.319 Printing equipment. milkfat shall be made by a continuous separation process directly from milk All printing equipment shall be de- or cream. The cream used shall be com- signed so as to adequately protect the parable to the flavor quality specified product and be readily demountable for above for U.S. Grade AA or U.S. Grade cleaning of product contact surfaces. All product contact surfaces shall be A butter. The milkfat from cream may aluminum, stainless steel or equally then be further concentrated into oil. corrosion resistant metal, or plastic, The cream or oil shall be pasteurized in rubber and rubber like material which accordance with the procedures for comply with 3–A standards, except that cream for buttermaking (§ 58.334a). If conveyors may be constructed of mate- butter is used in the production of an- rial which can be properly cleaned and hydrous milkfat that is eligible for of- maintained in a satisfactory manner. ficial certification, the butter used shall conform to the flavor require- § 58.320 Brine tanks. ments of U.S. Grade AA or U.S. Grade Brine tanks used for the treating of A butter and shall have been manufac- parchment liners shall be constructed tured in an approved plant. The appear- of noncorrosive material and have an ance of anhydrous milkfat should be adequate and safe means of heating the fairly smooth and uniform in consist- salt solution for the treatment of the ency. liners. The tank should also be pro- [60 FR 4826, Jan. 24, 1995] vided with a satisfactory drainage out- let. § 58.326 Plastic cream. § 58.321 Cream storage tanks. To produce plastic cream eligible for Cream storage tanks shall meet the official certification, the quality of the requirements of § 58.128(d). Cream stor- cream used shall meet the require- age tanks for continuous churns should ments of cream acceptable for the be equipped with effective temperature manufacture of U.S. Grade AA or U.S. controls and recording devices. Grade A butter.
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§ 58.327 Frozen cream. (a) Cream for butter making. The cream for butter making shall be pas- To produce frozen cream eligible for teurized at a temperature of not less official certification, the quality of the than 165 °F. and held continuously in a cream used shall meet the require- vat at such temperature for not less ments of cream acceptable for the than 30 minutes; or pasteurized by manufacture of U.S. Grade AA or U.S. HTST method at a minimum tempera- Grade A butter. ture of not less than 185 °F. for not less § 58.328 Salt. than 15 seconds; or it shall be pasteur- ized by any other equivalent tempera- The salt shall be free-flowing, white ture and holding time which will as- refined sodium chloride and shall meet sure adequate pasteurization. Addi- the requirements of The Food Chem- tional heat treatment above the min- ical Codex. imum pasteurization requirement is advisable to insure improved keeping- § 58.329 Color. quality characteristics. Coloring, when used shall be Annatto Adequate pasteurization control shall or any color which is approved by the be used and the diversion valve shall be U.S. Food and Drug Administration. set to divert at no less than 185 °F. with a 15 second holding time or its § 58.330 Butter starter cultures. equivalent in time and temperature to Harmless bacterial cultures when assure pasteurization. If the vat or used in the development of flavor com- holding method of pasteurization is ponents in butter and related products used, vat covers shall be closed prior to shall have a pleasing and desirable fla- holding period to assure temperature of vor and shall have the ability to trans- air space reaching 5 °F. higher than the mit these qualities to the finished minimum temperature during the hold- product. ing time. Covers shall also be kept closed during the holding and cooling § 58.331 Starter distillate. period. The refined flavor components when (b) Cream for plastic or frozen cream. used to flavor butter and related prod- The pasteurization of cream for plastic ucts. It shall be of food grade quality, or frozen cream shall be accomplished free of extraneous material and pre- in the same manner as in paragraph (a) pared in accordance with good com- of this section, except, that the tem- mercial practice. perature for the vat method shall be not less than 170 °F. for not less than 30 OPERATIONS AND OPERATING minutes, or not less than 190 °F. for not PROCEDURES less than 15 seconds or by any other temperature and holding time which § 58.332 Segregation of raw material. will assure adequate pasteurization and The milk and cream received at the comparable keeping-quality character- dairy plant shall meet the quality spec- istics. ifications as indicated under § 58.322. The milk and cream should be seg- § 58.335 Quality control tests. regated by quality and processed sepa- All milk, cream and related products rately in such a manner that the fin- are subject to inspection for quality ished product will fully meet the re- and condition throughout each proc- quirements of a particular U.S. Grade essing operation. Quality control tests or other specification, whichever is ap- shall be made on flow samples as often plicable. as necessary to check the effectiveness of processing and manufacturing and as § 58.334 Pasteurization. an aid in correcting deficiencies in The milk or cream shall be pasteur- processing and manufacturing. Routine ized at the plant where the milk or analysis shall be made on raw mate- cream is processed into the finished rials and finished products to assure product or by procedures as set forth adequate microbiological, composition by the Administrator. and chemical control.
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§ 58.336 Frequency of sampling for other methods giving equivalent re- quality control of cream, butter and sults. related products. (b) Microbiological. Microbiological (a) Microbiological. Samples shall be determinations shall be made in ac- taken from churnings or batches and cordance with the methods described or should be taken as often as is nec- suggested in the latest edition of essary to insure microbiological con- Standard Methods for the Examination trol. of Dairy Products, published by the (b) Composition. Sampling and testing American Public Health Association. for product composition shall be made on churns or batches as often as is nec- § 58.338 Composition and wholesome- essary to insure adequate composition ness. control. For in-plant control, the All ingredients used in the manufac- Kohman or modified Kohman test may ture of butter and related products be used. shall be subject to inspection and shall (c) Chemical—(1) Acid degree value. be wholesome and practically free from This test should be made on churnings impurities. Chlorinating facilities shall or batches from samples taken from be provided for butter wash water if the cream as often as is necessary to needed and all other necessary pre- aid in the control of lipase activity. cautions shall be taken to prevent con- (2) Free fatty acid. This test should be tamination of products. All finished made on churnings or batches from products shall comply with the require- samples taken from the butter as often ments of the Federal Food, Drug and as is necessary to aid in the control of Cosmetic Act, as to composition and lipase activity. wholesomeness. (d) Other analysis. Other chemical analysis or physical measurements § 58.339 Containers. shall be performed as often as is nec- (a) Containers used for the packaging essary to insure meeting grade stand- of butter and related products shall be ards and contract specifications. commercially acceptable containers or (e) Weight or volume control. Rep- packaging material that will satisfac- resentative samples of the packaged torily protect the quality of the con- product should be checked using proce- tents in regular channels of trade. Caps dures prescribed by the Administrator or covers which extend over the lip of during the packaging operation to as- the container shall be used on all cups sure compliance with the stated net or tubs containing two pounds or less, weight or volume on the container. to protect the product from contamina- (f) Keeping quality and stability. Sam- tion during subsequent handling. ples from churnings shall be subjected (b) Liners and wrappers. Supplies of to a seven day keeping quality test at parchment liners, wrappers and other a temperature of 72 °F. to establish and packaging material shall be protected maintain a satisfactory keeping qual- against dust, mold and other possible ity history. Optionally 98 °F. for 48 contamination. hours may be used, however, in case of (1) Prior to use, parchment liners for a dispute, the results of the seven days bulk butter packages shall be com- at 72 °F. will prevail. pletely immersed in a boiling salt solu- tion in a suitable container con- § 58.337 Official test methods. structed of stainless steel or other (a) Chemical. Chemical analyses ex- equally non-corrosive material. The cept where otherwise prescribed herein, liners shall be maintained in the solu- shall be made in accordance with the tion for not less than 30 minutes. The methods described in the latest edition liners shall be effectively treated with of Official Methods of Analysis of the a solution consisting of at least 15 Association of Official Analytical pounds of salt for every 85 pounds of Chemists, published by the Association water and shall be strengthened or of Official Analytical Chemists, the Of- changed as frequently as necessary to ficial and Tentative Methods of the keep the solution full strength and in American Oil Chemists Society or any good condition.
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(2) Other liners such as polyethylene number, churn number, etc.) and any shall be treated or handled in such a other identification that may be re- manner as to prevent contamination of quired. Packages of plastic or frozen the liner prior to filling. cream shall be marked with the per- (c) Filling bulk butter containers. The cent of milkfat. lined butter containers shall be pro- tected from possible contamination § 58.343 Storage of finished product in prior to filling. Use of parchment liners coolers. may be accomplished by alternately in- All products shall be kept under re- verting one container over the other or frigeration at temperatures of 40 °F. or stacking the lined boxes on their sides lower after packaging and until ready in a rack, until ready for use. When for distribution or shipment. The prod- using polyethylene liners the boxes ucts shall not be placed directly on should be lined immediately prior to floors or exposed to foreign odors or use. When packing butter into the bulk conditions such as drippage due to con- containers, care shall be taken to fill densation which might cause package the corners leaving as few holes or or product damage. openings as possible. The surface of the butter as well as the covering liner § 58.344 Storage of finished product in shall be smoothed evenly over the top freezer. surface before closing and sealing the container. Containers should be (a) Sharp freezers. Plastic cream or stacked only as high as the firmness of frozen cream intended for storage shall the product will support weight, so as be placed in quick freezer rooms imme- not to crush or distort the container. diately after packaging, for rapid and complete freezing within 24 hours. The § 58.340 Printing and packaging. packages shall be piled or spaced in Printing and packaging of consumer such a manner that air can freely cir- size containers of butter shall be con- culate between and around the pack- ages. The rooms shall be maintained at ducted under sanitary conditions. Sep- ¥ ° arate rooms equipped with automatic 10 F. or lower and shall be equipped filling and packaging equipment should to provide sufficient high velocity, air be provided. The outside cartons should circulation for rapid freezing. After the be removed from bulk butter in a room products have been completely frozen, outside of the printing operation but they may be transferred to a freezer the parchment removal and cutting of storage room for continued storage. the butter may be done in the print (b) Freezer storage. The room shall be ° room. maintained at a temperature of 0 F. or lower. Adequate air circulation is de- § 58.341 Repackaging. sirable. When officially graded or inspected Butter intended to be held more than bulk product is to be repackaged into 30 days shall be placed in a freezer consumer type packages for official room as soon as possible after pack- grade labeling or other official identi- aging. If not frozen before being placed fication, a supervisor of packaging in the freezer, the packages shall be shall be required and the plant, equip- spaced in such a manner as to permit ment, facilities and personnel shall rapid freezing and repiled, if necessary, meet the same specifications as out- at a later time. lined in this part, including such mark- ings or identification as may be re- REQUIREMENTS FOR FINISHED PRODUCTS quired. BEARING USDA OFFICIAL IDENTIFICA- TION § 58.342 General identification. Commercial bulk shipping containers § 58.345 Butter. shall be legibly marked with the name The quality requirements for butter of the product, net weight, name and shall be in accordance with the U.S. address of manufacturer, processor or Standards for Grades of Butter for U.S. distributor or other assigned plant Grade AA, U.S. Grade A, or U.S. Grade identification (manufacturer’s lot B, respectively.
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(a) In addition, the butter is subject (1) Proteolytic count, not more than to the following specifications when 50 per gram; yeast and mold count, not sampled and tested in accordance with more than 10 per gram; coliform count, §§ 58.336 and 58.337. not more than 10 per gram; and keep- (b) Proteolytic count, not more than ing-quality test, satisfactory after 7 100 per gram; yeast and mold count, days at 70°F. not more than 20 per gram; coliform (2) Optional except when required or count, not more than 10 per gram. requested: Copper content, not more (c) Optional except when required or than 0.3 ppm; iron content, not more requested: Copper content, not more than 0.3 ppm; iron content, not more than 1.0 ppm; enterococci, not more than 1.0 ppm; enterococci, not more than 10 per gram. than 10 per gram. [59 FR 1264, Jan. 10, 1994]
§ 58.346 Whipped butter. § 58.347 Butteroil or anhydrous (a) The quality requirements for milkfat. whipped butter shall be in accordance The flavor shall be bland and free with the U.S. Standards for Grades of from rancid, oxidized, or other objec- Whipped Butter for U.S. Grade AA and tionable flavors. U.S. Grade A, respectively. (a) In addition, the finished products (b) Whipped butter shall also be sub- ject to the following specifications shall meet the following specifications when sampled and tested in accordance when sampled and tested in accordance with § 58.336 and § 58.337, respectively: with §§ 58.336 and 58.337:
Butteroil Anhydrous milkfat
Milkfat ...... Not less than 99.6 percent ...... Not less than 99.8 percent. Moisture ...... Not more than 0.3 percent ...... Not more than 0.1 percent. Other butter constituents including salt ...... Not more than 0.1 percent ...... Not more than 0.1 percent. Salt ...... Not more than 0.05 percent ...... Not more than 0.05 percent. Antioxidants ...... Those permitted by standards of the Those permitted by standards of the Codex Alimentarius Commission Codex Alimentarius Commission and authorized for use by the and authorized for use by the Food and Drug Administration. Food and Drug Administration. Free fatty acids...... Not more than 0.5 percent (cal- Not more than 0.3 percent (cal- culated as oleic acid). culated as oleic acid). Peroxide value ...... Not more than 0.1 milliequivalent per Not more than 0.1 milliequivalent per kilogram of fat. kilogram of fat. Iron content ...... Not more than 0.2 ppm ...... Not more than 0.2 ppm. Copper content ...... Not more than 0.05 ppm ...... Not more than 0.05 ppm.
(b) [Reserved] (c) Optional except when required or requested: Copper content not more [60 FR 4826, Jan. 24, 1995] than 0.3 ppm; iron content not more § 58.348 Plastic cream. than 1.0 ppm. The flavor shall be sweet, pleasing § 58.349 Frozen cream. and desirable but may possess the fol- lowing flavors to a slight degree; aged, The flavor shall be sweet, pleasing bitter, flat, smothered and storage; and and desirable, but may possess the fol- cooked and feed flavors to a definite lowing flavors to a slight degree: Aged, degree. It shall be free from rancid, bitter, flat, smothered, storage; and oxidized or other objectionable flavors. cooked and feed flavors to a definite (a) In addition, the finished product degree. It shall be free from rancid, shall meet the following specifications oxidized or other objectionable flavors. when sampled and tested in accordance (a) In addition, the product shall with §§ 58.336 and 58.337. meet the following specifications when (b) Standard plate count, not more sampled and tested in accordance with than 30,000 per gram; coliform count, §§ 58.336 and 58.337. Samples for analysis not more than 10 per gram; yeast and should be taken prior to freezing of the mold, not more than 20 per gram; product.
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(b) Standard plate count, not more § 58.407 Make room. than 30,000 per ml.; coliform count, not The rooms in which the cheese is more than 10 per ml.; yeast and mold, manufactured shall be of adequate size, not more than 20 per ml. and the equipment adequately spaced (c) Optional except when required or to permit movement around the equip- requested: Copper content, not more ment for proper cleaning and satisfac- than 0.3 ppm; iron content not more tory working conditions. Adequate fil- than 1.0 ppm. tered air ventilation should be pro- vided. When applicable, the mold count SUPPLEMENTAL SPECIFICATIONS FOR should be not more than 15 colonies per PLANTS MANUFACTURING AND PACK- plate during a 15 minute exposure. AGING CHEESE § 58.408 Brine room. DEFINITIONS A brine room, when applicable, § 58.405 Meaning of words. should be a separate room constructed so it can be readily cleanable. The For the purpose of the regulations in brine room equipment shall be main- this subpart, words in the singular tained in good repair and corrosion form shall be deemed to impart the kept at a minimum. plural and vice versa as the case may demand. Unless the context otherwise § 58.409 Drying room. requires, the following terms shall When applicable, a drying room of have the following meaning: adequate size shall be provided to ac- (a) Cheese. The fresh or matured commodate the maximum production product obtained by draining after co- of cheese during the flush period. Ade- agulation of milk, cream, skimmed or quate shelving and air circulation shall partly skimmed milk or a combination be provided for proper drying. Tem- of some or all of these products and in- perature and humidity control facili- cluding any cheese that conforms to ties should be provided which will pro- the provisions of 21 CFR 19.500 up to mote the development of a sound, dry 19.750,1 ‘‘Definitions and Standards of surface of the cheese. Identity for Cheese and Cheese Prod- ucts,’’ Food and Drug Administration. § 58.410 Paraffining room. (b) Milkfat from whey. The fat ob- When applicable for rind cheese, a tained from the separation of cheese separate room or compartment should whey. be provided for paraffining and boxing the cheese. The room shall be of ade- ROOMS AND COMPARTMENTS quate size and the temperature main- tained near the temperature of the dry- § 58.406 Starter facility. ing room to avoid sweating of the A separate starter room or properly cheese prior to paraffining. designed starter tanks and satisfactory air movement techniques shall be pro- § 58.411 Rindless cheese wrapping vided for the propagation and handling area. of starter cultures. All necessary pre- For rindless cheese a suitable space caution shall be taken to prevent con- shall be provided for proper wrapping tamination of the facility, equipment and boxing of the cheese. The area and the air therein. A filtered air sup- shall be free from dust, condensation, ply with a minimum average efficiency mold or other conditions which may of 90 percent when tested in accordance contaminate the surface of the cheese with the ASHRAE Synthetic Dust or contribute to unsatisfactory pack- Arrestance Test should be provided so aging of the cheese. as to obtain outward movement of air from the room to minimize contamina- § 58.412 Coolers or curing rooms. tion. Coolers or curing rooms where cheese is held for curing or storage shall be 1 21 CFR part 19 was redesignated as part clean and maintained at the proper 133 at 42 FR 14302, Mar. 15, 1977. uniform temperature and humidity to
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adequately protect the cheese, and from side to center and from rear to minimize the undesirable growth of front for adequate drainage. The liner mold. Proper circulation of air shall be shall be smooth, free from excessive maintained at all times. The shelves dents or creases and shall extend over shall be kept clean and dry. This does the edge of the outer jacket. The outer not preclude the maintenance of suit- jacket shall be constructed of stainless able conditions for the curing of mold steel or other metal which can be kept and surface ripened varieties. clean and sanitary. The junction of the liner and outer jackets shall be con- § 58.413 Cutting and packaging rooms. structed so as to prevent milk or When small packages of cheese are cheese from entering the inner jacket. cut and wrapped, separate rooms shall (b) The vat, tank and/or drain table be provided for the cleaning and prepa- shall be equipped with a suitable sani- ration of the bulk cheese and for the tary outlet valve. Effective valves shall cutting and wrapping operation. The be provided and properly maintained to rooms shall be well lighted, ventilated control the application of heat to this and provided with filtered air. Air equipment. If this equipment is pro- movement shall be outward to mini- vided with removable cloth covers, mize the entrance of unfiltered air into they shall be clean. the cutting and packaging room. The waste materials and waste cheese shall § 58.417 Mechanical agitators. be disposed of in an environmentally The mechanical agitators shall be of and/or sanitary approved manner. sanitary construction. The carriages shall be of the enclosed type and all EQUIPMENT AND UTENSILS product contact surfaces, shields, shafts, and hubs shall be constructed of § 58.414 General construction, repair stainless steel or other equally corro- and installation. sion resistant metal. Metal blades, All equipment and utensils necessary forks, or stirrers shall be constructed to the manufacture of cheese and re- of stainless steel and of material ap- lated products shall meet the same proved in the 3–A Sanitary Standards general requirements as outlined in for Plastic, and Rubber and Rubber- § 58.128. In addition, for certain other Like Materials and shall be free from equipment the following requirements rough or sharp edges which might shall be met. scratch the equipment or remove metal particles. § 58.415 Starter vats. Bulk starter vats shall be of stainless § 58.418 Automatic cheese making steel or equally corrosion resistant equipment. metal and should be constructed ac- (a) Automatic Curd Maker. The auto- cording to the applicable 3–A Sanitary matic curd making system shall be Standards. New or replacement vats constructed of stainless steel or of ma- shall be constructed according to the terial approved in the 3–A Sanitary applicable 3–A Sanitary Standards. The Standards for Plastic, and Rubber and vats shall be in good repair, equipped Rubber-Like Material. All areas shall with tight fitting lids and have ade- be free from cracks and rough surfaces quate temperature controls such as and constructed so that they can be valves, indicating and/or recording easily cleaned. thermometers. (b) Curd conveying systems. The curd conveying system, conveying lines and § 58.416 Cheese vats, tanks and drain cyclone separator shall be constructed tables. of stainless steel or other equally cor- (a) The vats, tanks and drain tables rosion resistant metal and in such used for making cheese should be of manner that it can be satisfactorily metal construction with adequate jack- cleaned. The system shall be of suffi- et capacity for uniform heating. The cient size to handle the volume of curd inner liner shall be minimum 16 gauge and be provided with filtered air of the stainless steel or other equally corro- quality satisfactory for the intended sion resistant metal, properly pitched use. Air compressors or vacuum pumps
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shall not be located in the processing tinned and free from rust. All hoops, or packaging areas. forms, and followers shall be kept in (c) Automatic salter. The automatic good repair. Drums or other special salter shall be constructed of stainless forms used to press and store cheese steel or other equally corrosion resist- shall be clean and sanitary. ant metal. This equipment shall be constructed to equally distribute the § 58.421 Press. salt throughout the curd. It shall be The cheese press should be con- designed to accurately weigh the structed of stainless steel and all joints amount of salt added. The automatic welded and all surfaces, seams and salter shall be constructed so that it openings readily cleanable. The pres- can be satisfactorily cleaned. The salt- sure device shall be the continuous ing system shall provide for adequate type. Press cloths shall be maintained absorption of the salt in the curd. in good repair and in a sanitary condi- Water and steam used to moisten the tion. Single service press cloths shall curd prior to salting shall be potable be used only once. water or culinary steam. (d) Automatic curd filler. The auto- § 58.422 Brine tank. matic curd filler shall be constructed The brine tank shall be constructed of stainless steel or other equally cor- of suitable non-toxic material and rosion resistant metal. This equipment should be resistant to corrosion, pit- shall be of sufficient size to handle the ting or flaking. The brine tank shall be volume of curd and constructed and operated so as to assure the brine is controlled so as to accurately weigh clean, well circulated, and of the prop- the amount of curd as it fills. The curd er strength and temperature for the va- filler shall be constructed so that it riety of cheese being made. can be satisfactorily cleaned. (e) Hoop and barrel washer. The wash- § 58.423 Cheese vacuumizing chamber. er shall be constructed so that it can The vacuum chamber shall be satis- be satisfactorily cleaned. It shall also factorily constructed and maintained be equipped with temperature and pres- so that the product is not contami- sure controls to ensure satisfactory nated with rust or flaking paint. An cleaning of the hoops or barrels. It inner liner of stainless steel or other should be adequately vented to the out- corrosion resistant material should be side. provided.
§ 58.419 Curd mill and miscellaneous § 58.424 Monorail. equipment. The monorail shall be constructed so Knives, hand rakes, shovels, scoops, as to prevent foreign material from paddles, strainers, and miscellaneous falling on the cheese or cheese con- equipment shall be stainless steel or of tainers. material approved in the 3–A Sanitary Standards for Plastic and Rubber-like § 58.425 Conveyor for moving and Material. The product contact surfaces draining block or barrel cheese. of the curd mill should be of stainless The conveyor shall be constructed so steel. All pieces of equipment shall be that it will not contaminate the cheese so constructed that they can be kept and be easily cleaned. It shall be in- clean and free from rough or sharp stalled so that the press drippings will edges which might scratch the equip- not cause an environmental problem. ment or remove metal particles. The wires in the curd knives shall be stain- § 58.426 Rindless cheese wrapping less steel, kept tight and replaced when equipment. necessary. The equipment used to heat seal the wrapper applied to rindless cheese shall § 58.420 Hoops, forms and followers. have square interior corners, reason- The hoops, forms, and followers shall ably smooth interior surface and have be constructed of stainless steel, heavy controls that shall provide uniform tinned steel or other approved mate- pressure and heat equally to all sur- rials. If tinned, they shall be kept faces. The equipment used to apply
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shrinkable wrapping material to not contain added preservative. Appli- rindless cheese shall operate to main- cation and usage shall be as specified tain the natural intended shape of the in the ‘‘Definitions and Standards of cheese in an acceptable manner, rea- Identity for Cheese and Cheese Prod- sonably smooth surfaces on the cheese ucts’’, Food and Drug Administration. and tightly adhere the wrapper to the surface of the cheese. § 58.432 Catalase. The catalase preparation shall be a § 58.427 Paraffin tanks. stable, buffered solution, neutral in pH, The metal tank should be adequate having a potency of not less than 100 in size, have wood rather than metal Keil units per milliliter. The source of racks to support the cheese, have heat the catalase, its application and usage controls and an indicating thermom- shall be as specified in the ‘‘Definitions eter. The cheese wax shall be kept and Standards of Identity for Cheese clean. and Cheese Products,’’ Food and Drug Administration. § 58.428 Speciality equipment. All product contact areas of spe- § 58.433 Cheese cultures. ciality equipment shall be constructed Harmless microbial cultures used in of stainless steel or of material ap- the development of acid and flavor proved in the 3–A Sanitary Standards components in cheese shall have a for Plastic and Rubber and Rubber- pleasing and desirable taste and odor Like Material, and constructed fol- and shall have the ability to actively lowing 3–A Sanitary Standards prin- produce the desired results in the ciples. cheese during the manufacturing proc- ess. § 58.429 Washing machine. When used, the washing machine for § 58.434 Calcium chloride. cheese cloths and bandages shall be of Calcium chloride, when used, shall commercial quality and size; or of suf- meet the requirements of the Food ficient size to handle the applicable Chemical Codex. load. It should be equipped with tem- perature and water level controls. § 58.435 Color. Coloring when used, shall be Annatto QUALITY SPECIFICATIONS FOR RAW or any cheese or butter color which MATERIAL meet the requirements of the Food and § 58.430 Milk. Drug Administration. The milk shall be fresh, sweet, pleas- § 58.436 Rennet, pepsin, other milk ing and desirable in flavor and shall clotting enzymes and flavor en- meet the requirements as outlined zymes. under §§ 58.132 through 58.138. The milk Enzyme preparations used in the may be adjusted by separating part of manufacture of cheese shall be safe and the fat from the milk or by adding one suitable. or more of the following dairy prod- ucts: Cream, skim milk, concentrated § 58.437 Salt. skim milk, nonfat dry milk, and water The salt shall be free-flowing, white in a quantity sufficient to reconstitute refined sodium chloride and shall meet any concentrated or dry milk used. the requirements of the Food Chemical Such dairy products shall have origi- Codex. nated from raw milk meeting the same requirements as outlined under §§ 58.132 OPERATIONS AND OPERATING through 58.138. PROCEDURES
§ 58.431 Hydrogen peroxide. § 58.438 Cheese from pasteurized milk. The solution shall comply with the If the cheese is labeled as pasteur- specification of the U.S. Pharmacopeia, ized, the milk shall be pasteurized by except that it may exceed the con- subjecting every particle of milk to a centration specified therein and it does minimum temperature of 161 °F. for
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not less than 15 seconds or by any of Analysis of the Association of Offi- other acceptable combination of tem- cial Analytical Chemists as specified in perature and time treatment approved the appropriate standards of identity, by the Administrator. HTST pasteur- the latest edition of Standard Methods ization units shall be equipped with the or by other methods giving equivalent proper controls and equipment to as- results. sure pasteurization. If the milk is held (b) Weight or volume control. Rep- more than 2 hours between the time of resentative samples of the finished pasteurization and setting, it shall be product shall be checked during the cooled to 45 °F. or lower until time of packaging operation to assure compli- setting. ance with the stated net weight on the container of consumer size packages. § 58.439 Cheese from unpasteurized milk. § 58.443 Whey handling. If the cheese is labeled as ‘‘heat (a) Adequate sanitary facilities shall treated’’, ‘‘unpasteurized,’’ ‘‘raw be provided for the handling of whey. If milk’’, or ‘‘for manufacturing’’ the outside, necessary precautions shall be milk may be raw or heated at tempera- taken to minimize flies, insects and de- tures below pasteurization. Cheese velopment of objectionable odors. made from unpasteurized milk shall be cured for a period of 60 days at a tem- (b) Whey or whey products intended perature not less than 35 °F. If the milk for human food shall at all times be is held more than 2 hours between time handled in a sanitary manner in ac- of receipt or heat treatment and set- cordance with the procedures of this ting, it shall be cooled to 45 °F. or subpart as specified for handling milk lower until time of setting. and dairy products. (c) Milkfat from whey should not be § 58.440 Make schedule. more than four days old when shipped. A uniform schedule should be estab- lished and followed as closely as pos- § 58.444 Packaging and repackaging. sible for the various steps of setting, (a) Packaging rindless cheese or cut- cutting, cooking, draining the whey ting and repackaging all styles of bulk and milling the curd, to promote a uni- cheese shall be conducted under rigid form quality of cheese. sanitary conditions. The atmosphere of the packaging rooms, the equipment § 58.441 Records. and the packaging material shall be Starter and make records should be practically free from mold and bac- kept at least three months. terial contamination. (b) When officially graded bulk (Approved by the Office of Management and Budget under OMB control number 0583– cheese is to be repackaged into con- 0047) 1 sumer type packages with official grade labels or other official identifica- [40 FR 47911, Oct. 10, 1975. Redesignated at 42 tion, a supervisor of packaging shall be FR 32514, June 27, 1977, and further redesig- nated at 46 FR 63203, Dec. 31, 1981, as amend- required. If the repackaging is per- ed at 47 FR 745, Jan. 7, 1982] formed in a plant other than the one in which the cheese is manufactured and § 58.442 Laboratory and quality con- the product is officially identified, the trol tests. plant, equipment, facilities and per- (a) Chemical analyses—(1) Milkfat and sonnel shall meet the same require- moisture. One sample shall be tested ments as outlined in this part. from each vat of the finished cheese to assure compliance with composition § 58.445 General identification. requirements. Bulk cheese for cutting and the con- (2) Test method. Chemical analysis tainer for cheese for manufacturing shall be made in accordance with the shall be legibly marked with the name methods described in Official Methods of the product, code or date of manu- facture, vat number, officially des- 1 EDITORIAL NOTE: See table appearing in ignated code number or name and ad- § 58.100 for correct OMB control number. dress of manufacturer. Each consumer
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sized container shall meet the applica- ing the requirements of 21 CFR 19.525 1 ble regulations of the Food and Drug Food and Drug Administration. Administration. (2) Cottage cheese. The soft uncured cheese meeting the requirements of 21 REQUIREMENTS FOR FINISHED PRODUCTS CFR 19.530,1 Food and Drug Adminis- BEARING USDA OFFICIAL IDENTIFICA- tration. TION (3) Lowfat Cottage cheese. The soft uncured cheese meeting the require- § 58.446 Quality requirements. ments of 21 CFR 19.531,1 Food and Drug (a) Cheddar cheese. The quality re- Administration. quirements for Cheddar cheese shall be (c) Direct acidification. The production in accordance with the U.S. Standards of cottage cheese, without the use of for Grades of Cheddar Cheese. bacterial starter cultures, through the (b) Colby cheese. The quality require- use of approved food grade acids. This ments for Colby cheese shall be in ac- product shall be labeled according to cordance with the U.S. Standards for the requirements of 21 CFR 19.530(d),1 Grades of Colby Cheese. Food and Drug Administration. (c) Monterey (Monterey Jack) cheese. (d) Cottage cheese with fruits, nuts, The quality requirements for Monterey chives, or other vegetables. Shall consist (Monterey Jack) cheese shall be in ac- of cottage cheese to which has been cordance with the U.S. Standards for added fruits, nuts, chives or other vege- Grades of Monterey (Monterey Jack) tables. The finished cheese shall com- Cheese. ply with § 58.505(b). (d) Swiss cheese, Emmentaler cheese. (e) Cream. The milkfat portion of The quality requirements for Swiss milk which rises to the surface of milk cheese, Emmentaler cheese shall be in on standing or is separated from it by accordance with the U.S. Standards for centrifugal force and contains not less Grades for Swiss Cheese, Emmentaler than 18.0 percent of milkfat. Cheese. (f) Creaming mixture. The creaming mixture consists of cream or a mixture (e) Bulk American cheese for manufac- of cream with milk or skim milk or turing. The quality requirements for both. To adjust the solids content, non- bulk American cheese for manufac- fat dry milk or concentrated skim turing shall be in accordance with the milk may be added but not to exceed U.S. Standards for Grades of Bulk 3.0 percent by weight of the creaming American Cheese for Manufacturing. mixture. It may or may not contain a culture of harmless lactic acid and fla- SUPPLEMENTAL SPECIFICATIONS FOR vor producing bacteria, food grade acid, PLANTS MANUFACTURING AND PACK- salt, and stabilizers with or without AGING COTTAGE CHEESE carriers. The creaming mixture in its DEFINITIONS final form may or may not be homog- enized and shall conform to the provi- § 58.505 Meaning of words. sions of 21 CFR 19.530(b),1 Food and Drug Administration. For the purpose of the regulations in this subpart, words in the singular ROOMS AND COMPARTMENTS form shall be deemed to impart the plural and vice versa, as the case may § 58.510 Rooms and compartments. demand. Unless the context otherwise (a) Processing operations with open requires, the following terms shall cheese vats should be separated from have the following meaning: other rooms or areas. Excessive per- (a) Condensed skim. Skim milk which sonnel traffic or other possible con- has been condensed to approximately taminating conditions should be avoid- one-third the original volume in ac- ed. Rooms, compartments, coolers, and cordance with standard commercial practice. 1 See footnote at § 58.405. (b) Cottage cheese. (1) Cottage cheese 1 21 CFR part 20 was redesignated as part dry curd. The soft uncured cheese meet- 135 at 42 FR 14303, Mar. 15, 1977.
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dry storage space in which any raw ma- § 58.128. In addition for certain other terial, packaging or ingredients sup- equipment the following requirements plies or finished products are handled, shall be met. processed, packaged or stored shall be designed and constructed to assure § 58.512 Cheese vats or tanks. clean and orderly operations. (a) Cheese vats or tanks shall meet (b) Ventilation. Processing and pack- the requirements of § 58.416. When di- aging rooms or compartments shall be rect steam injection is used for heating ventilated to maintain sanitary condi- the milk, the vat or tank may be of tions, preclude the growth of mold and single shell construction. The steam air borne bacterial contaminants, pre- shall be culinary steam. vent undue condensation of water vapor and minimize or eliminate objec- (b) Vats shall be equipped with valves tionable odors. To minimize air borne to control the heating and cooling me- contamination in processing and pack- dium and a suitable sanitary outlet aging rooms a filtered air supply meet- valve. Vats used for creaming curd ing the requirements of § 58.510(c) shall should be equipped with a refrigerated be provided. The incoming air shall cooling medium. A circulating pump exert an outward pressure so that the for the heating and cooling medium is movement of air will be outward and recommended. prevent the movement of unfiltered air inward. § 58.513 Agitators. (c) Starter facility. A separate starter Mechanical agitators shall meet the room or properly designed starter requirements of § 58.417. tanks and satisfactory air movement techniques shall be provided for the § 58.514 Container fillers. propagation and handling of starter Shall comply with the 3–A Sanitary cultures. All necessary precautions shall be taken to prevent contamina- Standards for Equipment for Pack- tion of the room, equipment and the aging Frozen Desserts and Cottage air therein. A filtered air supply with a Cheese. minimum average efficiency of 90% when tested in accordance with the § 58.515 Mixers. ASHRAE Synthetic Dust Arrestance Only mixers shall be used which will Test should be provided so as to obtain mix the cheese carefully and keep shat- an outward movement of air from the tering of the curd particles to a min- room to minimize contamination. imum. They shall be constructed in (d) Coolers. Coolers shall be equipped such a manner as to be readily clean- with facilities for maintaining proper able. If shafts extend through the wall temperature and humidity conditions, of the tank below the level of the prod- consistent with good commercial prac- uct, they shall be equipped with proper tices for the applicable product, to pro- seals which are readily removable for tect the quality and condition of the cleaning and sanitizing. The mixer products. Coolers shall be kept clean, shall be enclosed or equipped with orderly and free from mold, and main- tight fitting covers. tained in good repair. They shall be adequately lighted and proper circula- § 58.516 Starter vats. tion of air shall be maintained at all times. The floors, walls, and ceilings Bulk starter vats shall meet the re- shall be of such construction as to per- quirements of § 58.415. mit thorough cleaning. QUALITY SPECIFICATIONS FOR RAW EQUIPMENT AND UTENSILS MATERIAL
§ 58.511 General construction, repair § 58.517 General. and installation. Raw materials used for manufac- The equipment and utensils used for turing cottage cheese shall meet the the manufacture and handling of cot- following quality specifications. tage cheese shall be as specified in
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§ 58.518 Milk. meet the requirements of The Food The selection of raw milk for cottage Chemical Codex. cheese shall be in accordance with (c) Other ingredients. Other ingredi- §§ 58.132 through 58.138. ents such as fruits, nuts, chives or other vegetables used or blended with § 58.519 Dairy products. cottage cheese shall be reasonably free (a) Raw skim milk. All raw skim milk of bacteria so as not to appreciably in- obtained from a secondary source shall crease the bacterial count of the fin- be separated from milk meeting the ished product. The various ingredients same quality requirements for milk as in kind shall be consistent in size and outlined in § 58.518 above. Skim milk color so as to produce the desired ap- after being pasteurized and separated pearance and appeal of the finished shall be cooled to 45 °F. or lower unless product. The flavor of the ingredients the skim milk is to be set for cheese used shall be natural and represent the within two hours after pasteurizing. intended flavor and intensity desired in The skim milk should not be more the finished product. Such ingredients than 48 hours old from the time the shall be clean, wholesome, of uniformly milk was received at the plant and the good quality, free from mold, rancid or skim milk is set for cheese. decomposed particles. Vegetables used (b) Nonfat dry milk. Nonfat dry milk, in cottage cheese may first be soaked when used, shall be obtained from milk for 15 to 20 minutes in a cold 25 to 50 meeting the same quality requirements ppm chlorine solution to appreciably as outlined in § 58.518 above. It shall be reduce the bacterial population. After processed according to the require- soaking, the vegetables shall be ments of this Subpart, and should meet drained and used soon thereafter. the requirements of § 58.236(b)(3). (c) Condensed skim milk. Condensed OPERATIONS AND OPERATING skim milk, if used, shall be prepared PROCEDURES from raw milk or skim milk that meets the same quality requirements § 58.521 Pasteurization and product outlined above for raw milk or skim flow. milk. It shall be cooled promptly after (a) The skim milk used for the manu- drawing from the vacuum pan or evap- facture of cottage cheese shall be pas- orator and shall have been pasteurized teurized not more than 24 hours prior before concentrating or during the to the time of setting by heating every manufacture. The standard plate count particle of skim milk to a temperature of the concentrated milk shall not ex- of 161 °F. for not less than 15 seconds or ceed 30,000 per ml. at time of use. by any other combination of tempera- (d) Cream. Any cream used for pre- paring the dressing for creamed cot- ture and time giving equivalent re- tage cheese shall be separated from sults. All skim milk must be cooled milk meeting at least the same quality promptly to setting temperature. If requirements as the skim milk used for held more than two hours between pas- making the curd. The flavor of the teurization and time of setting, the cream shall be fresh and sweet. Cream skim milk shall be cooled and held at obtained from a secondary source shall 45 °F. or lower until set. meet the same requirements. The (b) Cream or cheese dressing shall be creaming mixture prepared from this pasteurized at not less than 150 °F. for cream, after pasteurization, shall have not less than 30 minutes or at not less a standard plate count of no more than than 166 °F. for not less than 15 seconds 30,000 per ml. or by any other combination of tem- perature and time treatment giving § 58.520 Nondairy ingredients. equivalent results. Cream and cheese (a) Calcium chloride. Calcium chlo- dressing shall be cooled promptly to 40 ride, when used, shall be of food grade °F. or lower after pasteurization to aid quality and free from extraneous mate- in further cooling of cottage cheese rial. curd for improved keeping quality. (b) Salt. Salt shall be free flowing, (c) Reconstituted nonfat dry milk for white refined sodium chloride and shall cottage cheese manufacture need not
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be re-pasteurized provided it is recon- Official Analytical Chemists, the latest stituted within two hours prior to the edition of Standard Methods for the time of setting using water which is Examination of Dairy Products, or by free from viable pathogenic or other- other methods giving equivalent re- wise harmful microorganisms as well sults. as microorganisms which may cause spoilage of cottage cheese. Skim milk § 58.524 Packaging and general identi- separated from pasteurized whole milk fication. need not be re-pasteurized provided it (a) Containers. Containers used for is separated in equipment from which packaging cottage cheese shall be any all traces of raw milk from previous commercially acceptable multiple use operations have been removed by prop- or single service container or pack- er cleaning and sanitizing. aging material which will satisfac- torily protect the contents through the § 58.522 Reconstituting nonfat dry regular channels of trade without sig- milk. nificant impairment of quality with re- Nonfat dry milk shall be reconsti- spect to flavor, or contamination under tuted in a sanitary manner. normal conditions of handling. Caps or covers which extend over the lip of the § 58.523 Laboratory and quality con- container shall be used on all cups or trol tests. tubs containing two pounds or less, to (a) Quality control tests shall be protect the product from contamina- made on samples as often as necessary tion during subsequent handling. to determine the shelf-life and sta- (b) Packaging. The cheese shall be bility of the finished product. Routine packaged in a sanitary manner and analyses shall be made on raw mate- automatic filling and capping equip- rials and finished product to assure ment shall be used on all small sizes. satisfactory composition, shelf-life and The containers shall be checked stability. weighed during the filling operation to (b) Frequency of sampling—(1) Micro- assure they are filled uniformly to not biological. Samples of raw milk for test- less than the stated net weight on the ing shall be taken as prescribed in container. Also care shall be taken § 58.135. Representative samples shall that the cottage cheese be of uniform be taken of finished cottage cheese and consistency at the time of packaging from each lot or batch of product used to assure legal composition in all pack- as an ingredient. For keeping quality ages. tests representative samples shall be (c) General identification. Bulk pack- taken of finished cottage cheese; ages containing cottage cheese shall be (2) Chemical—(i) Milkfat and Moisture. adequately and legibly marked with Representative samples shall be taken the name of the product, net weight, of cottage cheese; dry cottage cheese name and address of the manufacturer, shall be tested for moisture only. lot number, code or date of packaging (ii) pH. Representative samples shall and any other identification as may be be taken of finished cottage cheese. required. Consumer size packaged prod- (c) Test methods—(1) Microbiological. ucts shall meet the applicable regula- Microbiological determinations shall tions of the Food and Drug Administra- be made for coliform, psychrotrophic tion. and yeasts and molds. These tests shall be made in accordance with the meth- § 58.525 Storage of finished product. ods described in the latest edition of Cottage cheese after packaging shall Standard Methods for the Examination be promptly stored at a temperature of of Dairy Products, published by the 45 °F. or lower to maintain quality and American Public Health Association. condition until loaded for distribution. (2) Chemical. Chemical analysis shall During distribution and storage prior be made in accordance with the meth- to sale the product should be main- ods described in the latest edition of tained at a temperature of 45 °F. or Official Methods of Analysis of the As- lower. The product shall not be exposed sociation of Official Analytical Chem- to foreign odors or conditions such as ists, published by the Association of drippage or condensation that might
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cause package or product damage. sufficiently tender to permit proper ab- Packaged cottage cheese shall not be sorption of cream or cheese dressing. placed directly on floors. The texture shall be smooth and vel- vety and shall not be mealy, crumbly, REQUIREMENTS FOR COTTAGE CHEESE pasty, sticky, mushy, watery, rubbery BEARING USDA OFFICIAL IDENTIFICA- or slimy or possess any other objec- TION tionable characteristics of body and § 58.526 Official identification. texture. Small curd style (cut with 1⁄4 (a) Only cottage cheese manufactured inch knives) should have curd particles 1 and packaged in accordance with the approximately ⁄4 inch or less in size. requirements of this part and with the Large curd style (cut with knives over applicable requirements in subpart A of 1⁄4 inch) should have curd particles ap- this part which has been officially in- proximately 3⁄8 inch or more in size. spected in process and found to be in (c) Color and appearance. The finished compliance with these requirements cottage cheese, creamed or plain curd, may be identified with the official shall have an attractive natural color USDA Quality Approved Inspection and appearance with curd particles of Shield. reasonably uniform size. The creamed (b) Nonfat dry milk. Nonfat dry milk, cottage cheese shall be uniformly when used in cottage cheese bearing of- mixed with the cream or dressing prop- ficial identification, shall meet the re- erly absorbed or adhering to the curd quirements for U.S. Extra Grade so as to prevent excessive drainage. (Spray Process), at time of use, and should be of U.S. Low Heat Classifica- § 58.528 Microbiological requirements. tion (not less than 6.0 mg. undenatured whey protein nitrogen per gram of non- Compliance shall be based on 3 out of fat dry milk). In addition, the nonfat 5 consecutive samples taken at the dry milk shall have a direct micro- time of packaging. scopic count not exceeding 75 million (a) Coliform. Not more than 10 per per gram. The age of the nonfat dry gram. milk shall be covered by a USDA grad- (b) Psychrotrophic. No more than 100 ing certificate, evidencing compliance per gram. with quality requirements, dated not (c) Yeasts and molds. Not more than 10 more than 6 months prior to use of the per gram. dry milk. In the interim between man- ufacture and use, the nonfat dry milk § 58.529 Chemical requirements. shall be stored in a clean, dry, vermin- free space. In any case, if the nonfat (a) Moisture. See § 58.505(b). dry milk is more than 120 days old, at (b) Milkfat. See § 58.505(b). time of use, it shall be examined for (c) pH. Not higher than 5.2. flavor to make certain that it meets (d) Phosphatase. Not more than 4 the requirements for U.S. Extra Grade. micrograms of phenol equivalent per gram of cheese. § 58.527 Physical requirements. (a) Flavor. The cottage cheese shall § 58.530 Keeping quality requirements. possess a mild pleasing flavor, similar Keeping quality samples taken from to fresh whole milk or light cream and the packaging line shall be held at 45 may possess the delicate flavor and °F. for 10 days. At the end of the 10 day aroma of a good lactic starter. The period the samples shall possess a sat- product may possess to a slight degree isfactory flavor and appearance, and a feed, acid, or salty flavor but shall be shall be free from bitter, sour, fruity, free from chalky, bitter, utensil, or other objectionable tastes and odors. fruity, yeasty, or other objectionable The surface shall not be discolored, flavors. translucent, slimy or show any other (b) Body and texture. The curd par- ticles shall have a meaty texture, but objectionable condition.
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SUPPLEMENTAL SPECIFICATIONS FOR ROOMS AND COMPARTMENTS PLANTS MANUFACTURING, PROCESSING AND PACKAGING FROZEN DESSERTS § 58.619 Mix processing room. The rooms used for combining mix DEFINITIONS ingredients and processing the mix shall meet the applicable requirements § 58.605 Meaning of words. for rooms specified in § 58.126. The room For the purpose of the regulations in shall be ventilated to remove moisture this subpart, words in the singular and prevent condensation from forming form shall be deemed to impart the on walls and ceiling. The room shall be plural and vice versa, as the case may well lighted. demand. Unless the context otherwise § 58.620 Freezing and packaging requires, the following terms shall rooms. have the following meaning as applied The rooms used for freezing and to frozen desserts meeting FDA re- packaging frozen desserts shall be ade- quirements and briefly defined as fol- quate in size to permit satisfactory air lows: circulation and maintained in a clean (a) Ice cream. The product conforming and sanitary condition. The rooms to the requirements of § 20.2 1 ‘‘Defini- shall be constructed in the same man- tions and Standards of Identity for ner as prescribed above for mix rooms. Frozen Desserts,’’ U.S. Food and Drug Administration (21 CFR 20.2).1 § 58.621 Freezing tunnels. (b) Frozen custard. The product con- Freezing tunnels for quick freezing at forming to the requirements of § 20.2 1 extremely low temperatures shall be ‘‘Definitions and Standards of Identity designed and constructed as to insure for Frozen Desserts,’’ U.S. Food and ease in cleaning and satisfactory condi- Drug Administration (21 CFR 20.2).1 tions of operation. (c) Ice milk. The product conforming § 58.622 Hardening and storage rooms. to the requirements of § 20.3 1 ‘‘Defini- tions and Standards of Identity for Hardening and storage rooms for fro- Frozen Desserts,’’ U.S. Food and Drug zen desserts shall be constructed of sat- Administration (21 CFR 20.3).1 isfactory material for this purpose. The (d) Sherbet. The product conforming rooms shall be maintained in a clean and orderly manner. Adequate shelves, to the requirements of § 20.4 1 ‘‘Defini- bins, or pallets shall be provided to tions and Standards of Identity for keep the packages of finished products Frozen Desserts,’’ U.S. Food and Drug off the floor and to prevent damage to 1 Administration (21 CFR 20.4). the containers. Sufficient refrigeration (e) Mellorine. The product conforming should be provided to insure adequate to the requirements of § 20.8 1 ‘‘Defini- storage temperature (¥10° or lower). tions and Standards of Identity for Air shall be circulated to maintain uni- Frozen Desserts,’’ U.S. Food and Drug form temperature throughout the Administration (21 CFR 20.8).1 rooms. A vestibule or double entry way (f) Overrun. The trade expression used should be provided to minimize heat to reference the increase in volume of shock of the frozen products. the frozen product over the volume of the mix. This increase in volume is due EQUIPMENT AND UTENSILS to air being whipped into the product § 58.623 Homogenizer. during the freezing process. It is ex- pressed as percent of the volume of the Homogenizer shall comply with 3–A mix. Sanitary Standards. (g) Mix. The trade name for the com- § 58.624 Freezers. bined and processed ingredients which Product contact surfaces of freezers after freezing become a frozen dessert. used to lower the temperature of the liquid mix to a semi-frozen mass by a 1 21 CFR part 20 was redesignated as part stirring action shall be constructed of 135 at 42 FR 14303, Mar. 15, 1977. a stainless steel or equally corrosion
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resistant metal and all parts easily ac- the finished product. Flavoring agents cessible for cleaning and sanitizing. shall be one or more of those approved Batch and continuous freezers should in § 58.605. comply with the applicable 3–A Stand- ards. § 58.630 Stabilizers. Stabilizers shall be clean and whole- § 58.625 Fruit or syrup feeders. some and consist of one or more of Fruit or syrup feeders inject fla- those approved in § 58.605. voring material into the semi-frozen product. Product contact surfaces shall § 58.631 Emulsifiers. be constructed of stainless steel or Emulsifiers shall be clean and whole- equally corrosion resistant metal and some and consist of one or more of all pumps shall be in accordance to 3– those approved in § 58.605. A Sanitary Standards for dairy equip- ment. The feeder shall be constructed § 58.632 Acid. to enable complete disassembly for Acids used in sherbet shall be whole- cleaning and sanitizing. some and of food grade quality and consist of one or more of those ap- § 58.626 Packaging equipment. proved in § 58.605. Packaging equipment designed to mechanically fill and close single serv- § 58.633 Color. ice containers with frozen desserts Coloring used for ice cream and re- shall be constructed so that all product lated products shall be those certified contact surfaces shall be of stainless by the U.S. Food and Drug Administra- steel or equally corrosion-resistant tion as safe for human consumption. metal. All product contact surfaces shall be easily accessible for cleaning. OPERATIONS AND OPERATING The design and operation of the ma- PROCEDURES chine shall in no way contaminate the container of the finished product § 58.634 Assembling and combining placed therein. New or replacement mix ingredients. equipment shall comply with the 3A The assembling and combining of Sanitary Standards for Equipment for mix ingredients for processing shall be Packaging Frozen Desserts and Cot- in accordance with clean and sanitary tage Cheese. methods and shall be consistent with good commercial practices. All raw QUALITY SPECIFICATIONS FOR RAW materials shall be subjected to inspec- MATERIAL tion for quality and condition prior to being combined and processed into the § 58.627 Milk and dairy products. finished mix. All necessary precautions To produce ice cream and related shall be taken to prevent the contami- products the raw milk and cream shall nation of any raw material or the fin- meet the quality requirements as pre- ished mix with any foreign substance. scribed in §§ 58.132 through 58.138, ex- cept that only commingled milk and § 58.635 Pasteurization of the mix. cream meeting the bacteriological re- Every particle of the mix, except quirements of No. 1 shall be used. added flavoring ingredients, shall be pasteurized at not less than 155 °F. and § 58.628 Sweetening agents. held at that temperature for 30 min- Sweetening agents shall be clean and utes or for 175 °F. for 25 seconds; or it wholesome and consist of one or more may be pasteurized by any other equiv- of the approved sweeteners listed in alent temperature and holding time § 58.605. which will assure adequate pasteuriza- tion. § 58.629 Flavoring agents. Flavoring agents either natural or § 58.636 Homogenization. artificial shall be wholesome and free Homogenization of the pasteurized from undesirable flavors. They must mix shall be accomplished to effec- impart the desired characteristic to tively reduce the size of the milkfat
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globules and evenly disperse them and sanitation and as an aid in cor- throughout the mix. recting deficiencies. Routine analysis shall be made on raw materials and fin- § 58.637 Cooling the mix. ished products to assure adequate com- The mix shall be immediately cooled position, weight or volume control. to a temperature of 45 °F. or lower, and stored at this temperature until fur- § 58.643 Frequency of sampling. ther processing begins. (a) Microbiological. Representative samples shall be taken from each type § 58.638 Freezing the mix. of mix, and for the finished frozen prod- After the mix enters the freezer, it uct one sample from each flavor made. shall be frozen as rapidly as possible to (b) Composition. Representative sam- assure the formation of minute crys- ples shall be tested for fat and solids- tals. Proper adjustment of rate of flow, not-fat on each type of mix manufac- refrigerant and air pressure controls tured. Spot checks shall be made on shall be achieved to assure correct the finished products as often as is nec- overrun and consistency of the product essary to assure compliance with com- for packaging and further freezing. position standards. § 58.639 Addition of flavor. (c) Weight or volume control. Rep- resentative samples of the packaged The addition of flavoring ingredients products shall be checked during the to semi-frozen mix just prior to pack- packaging operation to assure compli- aging shall be performed in a clean and ance with the stated volume on the sanitary manner. Care shall be taken container as well as weight and over- to insure the flavor injection equip- run requirements. ment has been properly cleaned and sanitized prior to use and that the fla- § 58.644 Test methods. vor ingredients are of good quality and wholesome. (a) Microbiological. Microbiological determinations shall be made in ac- § 58.640 Packaging. cordance with the methods described in The packaging of the semifrozen the latest edition of Standard Methods product shall be done by means which for the Examination of Dairy Products. will in no way contaminate the con- (b) Chemical. Chemical analysis shall tainer or the product. When single be made in accordance with the meth- service containers and lids are used, ods described in the latest edition of they shall be of good construction and Official Methods of Analysis of the As- protect the finished product. Con- sociation of Official Analytical Chem- tainers used for frozen products shall ists, the latest edition of Standard be stored and handled in a sanitary Methods, or by other methods giving manner so as to protect them from equivalent results. dust and bacterial contamination. § 58.645 General identification. § 58.641 Hardening and storage. The various types of frozen desserts Immediately after the semifrozen shall be packaged and labeled in ac- product is placed in its intended con- cordance with the applicable regula- tainer it shall be placed in a hardening tions of the Food and Drug Administra- tunnel or hardening room to continue tion. the freezing process. Rapid freezing to 0° to ¥15 °F is desirable to produce a REQUIREMENTS FOR FINISHED PRODUCTS good textured product. BEARING USDA OFFICIAL IDENTIFICA- TION § 58.642 Quality control tests. All mix ingredients shall be subject § 58.646 Official identification. to inspection for quality and condition (a) Only ice cream and related prod- throughout each processing operation. ucts manufactured and packaged in ac- Quality control tests shall be made on cordance with the requirements of this flow line samples as often as necessary part and with the applicable require- to check the effectiveness of processing ments in subpart A of this part which
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have been officially inspected in proc- § 58.651 Requirements for ice milk. ess and found to be in compliance with The requirements are the same as for these requirements may be identified ice cream except: (a) The minimum with the official USDA Quality Ap- milk fat content shall be 2 percent by proved Inspection Shield. weight and the maximum milk fat con- (b) Dairy products used in the manu- tent 7 percent by weight, (b) the total facture of frozen desserts for which milk solids content shall be no less there are U.S. grades established (non- than 11 percent by weight, (c) the min- fat dry milk, whole milk, buttermilk imum total food solids weight per gal- and whey) shall be U.S. Extra Grade or lon shall be 1.3 pounds, (d) no reduction better, and in the case of unsalted but- in the standards are permitted when ter, shall be no lower than U.S. Grade fruits, nuts and other such ingredients A. Dairy products for which there are are used for flavoring. not USDA grade shall meet the appli- cable requirements of this part which § 58.652 Composition requirements for permit such product to bear the USDA sherbet. Quality Approved Inspection Shield. See § 58.605(d). § 58.647 Composition requirements for ice cream. § 58.653 Microbiological requirements for sherbet. See § 58.605(a). The finished product shall contain not more than 50,000 bacteria per gram § 58.648 Microbiological requirements for ice cream. as determined by the standard plate count and shall contain not more than The finished product shall contain 10 coliform organisms per gram in not more than 50,000 bacteria per gram three out of five samples. as determined by the standard plate count, and shall contain not more than § 58.654 Physical requirements for 10 coliform organisms per gram for sherbet. plain and not more than 20 coliform per (a) Flavor. The flavor of the finished gram in chocolate, fruit, nut or other sherbet shall be pleasing and desirable flavors in three out of five samples. and characteristic of the particular fla- voring used and shall impart a sweet § 58.649 Physical requirements for ice cream. yet tart sensation. (b) Body and texture. The body shall (a) Flavor. The flavor of the finished be firm, compact, somwhat chewy and ice cream shall be pleasing and desir- readily melt to an even syrupy consist- able, and characteristic of the fresh ency at room temperatures; the tex- milk and cream and the particular fla- ture shall be smooth but not as fine as voring used. in ice cream and shall be even through- (b) Body and texture. The body shall out. be firm, have substance and readily (c) Color. The color shall be attrac- melt to a creamy consistency when ex- tive, pleasing, uniform and char- posed to room temperatures; the tex- acteristic of the flavor represented. ture shall be fine, smooth, and have the appearance of creaminess throughout. SUPPLEMENTAL SPECIFICATIONS FOR (c) Color. The color shall be attrac- PLANTS MANUFACTURING, PROCESSING tive, pleasing, uniform and char- AND PACKAGING PASTEURIZED PROCESS acteristic of the flavor represented. CHEESE AND RELATED PRODUCTS
§ 58.650 Requirements for frozen cus- DEFINITIONS tard. § 58.705 Meaning of words. The same requirements apply as for ice cream except plain frozen custard (a) Pasteurized process cheese and re- shall have a minimum egg yolk solids lated products. Pasteurized process content of 1.4 percent, and 1.12 percent cheese and related products are the when fruits, nuts and other such ingre- foods which conform to the applicable dients are used for flavoring. provisions of part 19, title 21, §§ 19.750
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through 19.790,1 ‘‘Definitions and satisfactory time charts are obtained, Standards of Identity for Cheese and if not, the stem shall be placed in the Cheese Products,’’ Food and Drug Ad- hotwell or filler hopper. Steam check ministration. valves on direct steam type cookers (b) Blend set up. The trade term for a shall be mounted flush with cooker particular group of vat lots of cheese wall, be constructed of stainless steel selected to form a blend based upon and designed to prevent the backup of their combined ability to impart the product into the steam line, or the desired characteristics to a pasteurized steam line shall be constructed of process cheese product. stainless steel pipes and fittings which (c) Cooker batch. The amount of can be readily cleaned. If direct steam cheese and added optional ingredients is applied to the product only culinary placed into a cooker at one time, heat- steam shall be used (see § 58.127(d)). ed to pasteurization temperature, and held for the required length of time. § 58.710 Fillers. A strainer should be installed be- EQUIPMENT AND UTENSILS tween the cooker and the filler. The § 58.706 General construction, repair hoppers of all filters shall be covered and installation. but the cover may have sight ports. If necessary, the hopper may have an agi- The equipment and utensils used for tator to prevent buildup on side wall. the handling and processing of cheese The filler valves and head shall be kept products shall be as specified in § 58.128 in good repair and capable of accurate of this subpart. In addition, for certain measurements. Product contact sur- other equipment the following require- faces shall be of stainless steel or other ments shall be met. corrosion resistant material. § 58.707 Conveyors. QUALITY SPECIFICATIONS FOR RAW Conveyors shall be constructed of MATERIAL material which can be properly cleaned, will not rust, or otherwise § 58.711 Cheddar, colby, washed or contaminate the cheese, and shall be soaked curd, granular or stirred maintained in good repair. curd cheese. Cheese, used in the manufacture of § 58.708 Grinders or shredders. pasteurized process cheese products The grinders or shredders used in the should possess a pleasing and desirable preparation of the trimmed and taste and odor consistent with the age cleaned cheese shall be of corrosion-re- of the cheese; should have body and sistant material, and of such construc- texture characteristics which will im- tion as to prevent contamination of the part the desired body and texture char- cheese and to allow thorough cleaning acteristics in the finished product; and of all parts and product contact sur- should possess finish and appearance faces. characteristics which will permit re- moval of all packaging material and § 58.709 Cookers. surface defects. The cheese should at The cookers shall be the steam jack- least meet the requirements equivalent eted or direct steam type. They shall to U.S. Standard Grade for Bulk Amer- be constructed of stainless steel or ican Cheese for Manufacturing pro- other equally corrosion-resistant mate- vided the quantity of the cheese with rial. All product contact surfaces shall any one defect as listed for U.S. Stand- be readily accessible for cleaning. Each ard Grade is limited to assure a satis- cooker shall be equipped with an indi- factory finished product. cating thermometer, and shall be equipped with a temperature recording § 58.712 Swiss. device. The recording thermometer Swiss cheese used in the manufacture stem may be placed in the cooker if of pasteurized process cheese and re- lated products should be equivalent to 1 21 CFR Part 18 was redesignated as Part U.S. Grade B or better, except that the 131 at 42 FR 14302, Mar. 15, 1977. cheese may be blind or possess finish
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characteristics which do not impair the § 58.719 Coloring. interior quality. Coloring shall be Annatto or any § 58.713 Gruyere. other cheese or butter color which is approved by the Food and Drug Admin- Gruyere cheese used in the manufac- istration. ture of process cheese and related prod- ucts should be of good wholesome qual- § 58.720 Acidifying agents. ity and except for smaller eyes and Acidifying agents if used shall be sharper flavor shall meet the same re- those permitted by the Food and Drug quirements as for Swiss cheese. Administration for the specific pas- § 58.714 Cream cheese, Neufchatel teurized process cheese product. cheese. § 58.721 Salt. These cheeses when mixed with other Salt shall be free flowing, white re- foods, or used for spreads and dips fined sodium chloride and shall meet should possess a fresh, pleasing and de- the requirements of The Food Chem- sirable flavor. ical Codex. § 58.715 Cream, plastic cream and an- hydrous milkfat. § 58.722 Emulsifying agents. These food products shall be pasteur- Emulsifying agents shall be those ized, sweet, have a pleasing and desir- permitted by the Food and Drug Ad- able flavor and be free from objection- ministration for the specific pasteur- able flavors, and shall be obtained from ized process cheese product, and shall milk which complies with the quality be free from extraneous material. requirements as specified in §§ 58.132 OPERATIONS AND OPERATING through 58.138 of this subpart. PROCEDURES
§ 58.716 Nonfat dry milk. § 58.723 Basis for selecting cheese for Nonfat dry milk used in cheese prod- processing. ucts should meet the requirements A representative sample shall have equivalent to U.S. Extra Grade except been examined to determine fat and that the moisture content may be in moisture content. One sample unit excess of that specified for the par- from each vat of cheese shall have been ticular grade. examined to determine the suitability of the vat for use in process cheese § 58.717 Whey. products in accordance with the flavor, Whey used in cheese products should body and texture characteristics per- meet the requirements equivalent to mitted in §§ 58.711 through 58.714 as ap- USDA Extra Grade except that the plicable, and to determine the charac- moisture requirement for dry whey teristics it will contribute to the fin- may be waived. ished product when blended with other cheese. The cheese included in each § 58.718 Flavor ingredients. blend shall be selected on the basis of Flavor ingredients used in process the desirable qualities which will re- cheese and related products shall be sult in the desired finished product. those permitted by the Food and Drug Recook from equivalent blends may be Standards of Identity, and in no way used in an amount that will not ad- deleterious to the quality or flavor of versely affect the finished product. Hot the finished product. In the case of cheese from the filler may be added to bulky flavoring ingredients such as pi- the cooker in amounts which will not mento, the particles should be, to at adversely affect the finished product. least a reasonable degree, uniform in size, shape and consistency. The indi- § 58.724 Blending. vidual types of flavoring materials To as great an extent as is practical, should be uniform in color and should each vat of cheese should be divided impart the characteristic flavor de- and distributed throughout numerous sired in the finished product. cooker batches. The purpose being to
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minimize the preponderance and con- § 58.729 Forming containers. sequent influence of any one vat on the Containers either lined or unlined characteristics of the finished product, shall be assembled and stored in a sani- and to promote as much uniformity as tary manner to prevent contamination. is practical. In blending also consider The handling of containers by filler the final composition requirements for crews should be done with extreme care fat and moisture. Quantities of salt, and observance of personal cleanliness. color, emulsifier and other allowable Preforming and assembling of pouch ingredients to be added shall be cal- liners and containers shall be kept to a culated and predetermined for each minimum and the supply rotated to cooker batch. limit the length of time exposed to pos- § 58.725 Trimming and cleaning. sible contamination prior to filling. The natural cheese shall be cleaned § 58.730 Filling containers. free of all non-edible portions. Paraffin Hot fluid cheese from the cookers and bandages as well as rind surface, may be held in hotwells or hoppers to mold or unclean areas or any other assure a constant and even supply of part which is unwholesome or processed cheese to the filler or slice unappetizing shall be removed. former. Filler valves shall effectively § 58.726 Cutting and grinding. measure the desired amount of product into the pouch or container in a sani- The trimmed and cleaned cheese tary manner and shall cut off sharply should be cut into sections of conven- without drip or drag of cheese across ient size to be handled by the grinder the opening. An effective system shall or shredder. The grinding and mixing be used to maintain accurate and pre- of the blended lots of cheese should be cise weight control. Damaged or unsat- done in such a manner as to insure a isfactory packages shall be removed homogeneous mixture throughout the from production, and the cheese may batch. be salvaged into sanitary containers, and added back to cookers. § 58.727 Adding optional ingredients. As each batch is added to the cooker, § 58.731 Closing and sealing con- the predetermined amounts of salt, tainers. emulsifiers, color, or other allowable Pouches, liners, or containers having optional ingredients shall be added. product contact surfaces, after filling However, a special blending vat may be shall be folded or closed and sealed in a used to mix the ground cheese and sanitary manner, preferably by me- other ingredients before they enter the chanical means, so as to assure against cooker to provide composition control. contamination. Each container in addi- tion to other required labeling shall be § 58.728 Cooking the batch. coded in such a manner as to be easily Each batch of cheese within the identified as to date of manufacture by cooker, including the optional ingredi- lot or sublot number. ents, shall be thoroughly commingled and the contents pasteurized at a tem- § 58.732 Cooling the packaged cheese. perature of at least 158 °F. and held at After the containers are filled they that temperature for not less than 30 shall be stacked, or cased and stacked seconds or any other equally effective in such a manner as to prevent break- combination of time and temperature ing of seals due to excessive bulging approved by the Administrator. Care and to allow immediate progressive shall be taken to prevent the entrance cooling of the individual containers of of cheese particles or ingredients after cheese. As a minimum the cheese the cooker batch of cheese has reached should be cooled to a temperature of the final heating temperature. After 100 °F. or lower within 24 hours after holding for the required period of time, filling. The temperature of the cheese the hot cheese shall be emptied from should be reduced further, before being the cooker as quickly as possible. shipped or if storage is intended.
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§ 58.733 Quality control tests. REQUIREMENTS FOR PROCESSED CHEESE PRODUCTS BEARING USDA OFFICIAL (a) Chemical analyses. The following IDENTIFICATION chemical analyses shall be performed in accordance with the appropriate edi- § 58.734 Official identification. tion of the Official Methods of Analysis Only process cheese products manu- of the AOAC as specified in the appro- factured and packaged in accordance priate Standards of Identity or in ac- with the requirements of this part and cordance with methods that give equiv- with the applicable requirements in alent results. subpart A of this part which have been (1) Cheese. A representative sample of officially inspected in process and cheese used in the manufacture of pas- found to be in compliance with these teurized process cheese products shall requirements may be identified with have been tested prior to usage to de- official USDA Quality Approved In- termine its moisture and fat content. spection Shield. (2) Pasteurized process cheese products. As many samples shall be taken of the § 58.735 Quality specifications for raw materials. finished product direct from the cook- er, hopper, filler, or other location as is (a) Cheddar colby, washed or soaked necessary to assure compliance with curd, granular or stirred curd cheese. composition requirements. Spot checks Cheese, used in the manufacture of pas- should be made on samples from the teurized process cheese products which are identified with the USDA official cooker as frequently as is necessary to identification shall possess a pleasing indicate pasteurization by means of the and desirable taste and odor consistent phosphatase test, as well as any other with the age of the cheese; shall have tests necessary to assure good quality body and texture characteristics which control. will impart the desired body and tex- (b) Examination of physical characteris- ture characteristics in the finished tics. As many samples shall be taken as product; and shall possess finish and is necessary to assure meeting the re- appearance characteristics which will quired physical characteristics of the permit removal of all packaging mate- products. Representative samples shall rial and surface defects. The cheese be taken from production for examina- shall at least meet the requirements of tion of physical characteristics. The U.S. Standard Grade for Bulk Amer- samples shall be examined at approxi- ican Cheese for Manufacturing pro- mately 70 °F. the first day of operation vided the quantity of the cheese with after the date of processing for the fol- any one defect as listed for U.S. Stand- lowing characteristics: (1) Finish and ard Grade is limited, to assure compli- appearance, (2) flavor, (3) color, (4) ance with the specifications of the fin- body and texture, and (5) slicing or ished product. spreading properties. (b) Swiss. Swiss cheese used in the (c) Keeping quality. During processing manufacture of pasteurized process cheese and related products bearing of- or preferably from the cooled stock se- ficial identification shall be U.S. Grade lect sufficient samples at random from B or better, except that the cheese may the production run. The samples should be blind or possess finish characteris- be stored at approximately 50 °F. for 3 tics which do not impair the interior months for evaluation of physical char- quality. acteristics as in paragraph (b) of this (c) Gruyere. Gruyere cheese used in section. Additional samples may be se- the manufacture of process cheese and lected and held at different tempera- related products shall be of good whole- tures or time. some quality and except for smaller (d) Weight control. During the filling eyes and sharper flavor shall meet the operation as many samples shall be same requirements as for Swiss cheese. randomly selected and weighed from (d) Cream cheese, Neufchatel cheese. each production run as is necessary to Mixed with other foods, or used for assure accuracy of the net weight es- spreads and dips shall possess a fresh, tablished for the finished products. pleasing and desirable flavor.
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(e) Cream, plastic cream and anhydrous cheese ingredients used. If additional milkfat. These food products shall be optional ingredients are used they pasteurized, sweet, have a pleasing and shall be incorporated in accordance desirable flavor and be free from objec- with good commercial practices and tionable flavors, and shall be obtained the flavor imparted shall be pleasing from milk which complies with the and desirable. May have a slight quality requirements as specified in cooked or very slight acid or emulsifier § 58.132 of this subpart. flavor; is free from any undesirable (f) Nonfat dry milk. Nonfat dry milk tastes and odors. used in officially identified cheese (b) Body and texture. Shall have a me- products shall meet the requirements dium-firm, smooth and velvety body of U.S. Extra Grade except that the free from uncooked cheese particles. Is moisture content may be in excess of resilient and not tough, brittle, short, that specified for the particular grade. weak, or sticky. It shall be free from (g) Whey. Condensed or dry whey pin holes or openings except those used in officially identified cheese caused by trapped steam. The cheese products shall meet the requirements shall slice freely, and shall not stick to for USDA Extra Grade except that the the knife or break when cut into ap- moisture requirement for dry whey proximately 1⁄8 inch slices. If in sliced may be waived. form, the slices shall separate readily. (h) Flavor ingredients. Flavor ingredi- (c) Color. May be colored or uncolored ents used in process cheese and related but shall be uniform throughout. If col- products shall be those permitted by ored it shall be bright and not be dull the Food and Drug Standards of Iden- or faded. To promote uniformity and a tity, and in no way deleterious to the common reference to describe color use quality or flavor of the finished prod- the color designations as depicted by uct. In the case of bulky flavoring in- the National Cheese Institute standard gredients such as pimento, the par- color guide for cheese. ticles shall be, to at least a reasonable (d) Finish and appearance. The wrap- degree, uniform in size, shape and con- per may be slightly wrinkled but shall sistency. The individual types of fla- envelop the cheese, adhere closely to voring materials shall be uniform in the surface, and be completely sealed color and shall impart the char- and not broken or soiled. acteristic flavor desired in the finished product. § 58.737 Pasteurized process cheese (i) Other ingredients. For coloring, food. acidifying agents, salt, and emulsifying agents see §§ 58.719, 58.720, 58.721 and Shall conform to the provisions of 58.722. the Definitions and Standards of Iden- tity for Pasteurized Process Cheese QUALITY SPECIFICATIONS FOR FINISHED Food and Related Products, Food and PRODUCTS Drug Administration. The average age of the cheese in the blend shall be such § 58.736 Pasteurized process cheese. that the desired flavor, body and tex- Shall conform to the provisions of ture will be achieved in the finished the Definitions and Standards of Iden- product. The quality of pasteurized tity for Pasteurized Process Cheese and process cheese food shall be determined Related Products, Food and Drug Ad- on the basis of flavor, body and tex- ministration. The average age of the ture, color, and finish and appearance. cheese in the blend shall be such that (a) Flavor. Has a pleasing and desir- the desired flavor, body and texture able mild cheese taste and odor char- will be achieved in the finished prod- acteristic of the variety or varieties of uct. The quality of pasteurized process cheese ingredients used. If additional cheese shall be determined on the basis optional ingredients are used they of flavor, body and texture, color, and shall be incorporated in accordance finish and appearance. with good commercial practices and (a) Flavor. Has a pleasing and desir- the flavor imparted shall be pleasing able mild cheese taste and odor char- and desirable. May have a slight acteristic of the variety or varieties of cooked or very slight acid or emulsifier
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flavors; is free from any undesirable trapped steam. Product made for slic- tastes and odors. ing shall slice freely when cut into ap- (b) Body and texture. Shall have a rea- proximately 1⁄8 inch slices with only a sonably medium-firm smooth and vel- slight amount of sticking. Product vety body and free from uncooked made for spreading shall be spreadable cheese particles. Is resilient and not at approximately 70 °F. tough, brittle, short or sticky. It shall (c) Color. May be colored or uncolored be free from pin holes or openings ex- but shall be uniform throughout. If col- cept those caused by trapped steam. ored it shall be bright and not be dull The product shall slice freely with only or faded. To promote uniformity and a a slight amount of sticking and shall common reference to describe color the not break when cut into approximately color designations as depicted by the 1 ⁄8 inch slices. If in sliced form, the National Cheese Institute standard slices shall separate readily. color guide for cheese may be used. (c) Color. May be colored or uncolored (d) Finish and appearance. Wrappers, but shall be uniform throughout. If col- if used, may be slightly wrinkled but ored it shall be bright and not be dull shall envelop the cheese, adhere closely or faded. To promote uniformity and a to the surface, and be completely common reference to describe color use the color designations as depicted by sealed and not broken or soiled. Other the National Cheese Institute standard containers made of suitable materials color guide for cheese. shall be completely filled, sealed and (d) Finish and appearance. The wrap- not broken or soiled. per may be slightly wrinkled but shall SUPPLEMENTAL SPECIFICATIONS FOR envelop the cheese, adhere closely to PLANTS MANUFACTURING, PROCESSING, the surface, and be completely sealed AND PACKAGING WHEY, WHEY PROD- and not broken or soiled. UCTS AND LACTOSE § 58.738 Pasteurized process cheese spread and related products. DEFINITIONS Shall conform to the applicable pro- § 58.805 Meaning of words. visions of the Definitions and Stand- ards of Identity for Pasteurized Process For the purpose of the regulations in Cheese Spreads, Food and Drug Admin- this subpart, words in the singular istration. The pH of pasteurized proc- form shall be deemed to impart the ess cheese spreads shall not be below plural and vice versa, as the case may 4.0. demand. Unless the context otherwise The quality of pasteurized process requires, the following terms shall cheese spreads shall be determined on have the following meaning: the basis of flavor, body and texture, (a) Whey. ‘‘Whey’’ is the fluid ob- color, and finish and appearance. tained by separating the coagulum (a) Flavor. Has a pleasing and desir- from milk, cream, and/or skim milk in able cheese taste and odor char- cheesemaking. The acidity of the whey acteristic of the variety or varieties of may be adjusted by the addition of safe cheese ingredients used. If additional and suitable pH adjusting ingredients. optional ingredients are used they Moisture removed from cheese curd as shall be incorporated in accordance a result of salting may be collected for with good commercial practices and further processing as whey if the col- the flavor imparted shall be pleasing lection of the moisture and the re- and desirable. May have a slight moval of the salt from the moisture are cooked, acid, or emulsifier flavor; is conducted in accordance with proce- free from any undesirable tastes and dures approved by the Administrator. odors. (b) Dry Whey. ‘‘Dry Whey’’ is the (b) Body and texture. Shall have a product resulting from drying fresh smooth body free from uncooked whey which has been pasteurized and cheese particles and when packaged to which nothing has been added as a shall form into a homogeneous plastic preservative. It contains all constitu- mass, and be free from pin holes or ents, except moisture, in the same rel- openings except those caused by ative proportions as in the whey.
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(c) Dry Sweet Whey. Dry whey not equipment shall be of sanitary con- over 0.16 percent titratable acidity on a struction and readily cleanable. reconstituted basis. (b) Lactose. Equipment used in the (d) Dry Whey—% Titratable Acidity. further processing of lactose following Dry whey over 0.16 percent, but below its separation from whey shall have 0.35 percent titratable acidity on a re- smooth surfaces, be cleanable, free constituted basis. The blank being from cracks or crevices, readily acces- filled with the actual acidity. sible for inspection and shall be con- (e) Dry Acid Whey. Dry whey with 0.35 structed of non-toxic material meeting percent or higher titratable acidity on applicable Food and Drug Administra- a reconstituted basis. tion requirements and under conditions (f) Modified Whey Products: of use shall be resistant to corrosion, (1) Partially demineralized whey, pitting or flaking. [The use of stainless (2) Partially delactosed whey, steel is optional.] (3) Demineralized whey, and (4) Whey protein concentrate-prod- QUALITY SPECIFICATIONS FOR RAW ucts defined by regulations of the Food MATERIALS and Drug Administration. (g) Lactose (milk sugar). That food § 58.808 Whey. product defined by regulations of the Whey for processing shall be fresh Food and Drug Administration. and originate from the processing of [40 FR 47911, Oct. 10, 1975. Redesignated at 42 products made from milk meeting the FR 32514, June 27, 1977, as amended at 46 FR requirements as outlined in §§ 58.132 1257, Jan. 6, 1981. Redesignated at 46 FR 63203, through 58.138. Only those ingredients Dec. 31, 1981, as amended at 55 FR 39912, Oct. approved by the Food and Drug Admin- 1, 1990] istration may be added to the whey for processing, except when restricted by ROOMS AND COMPARTMENTS this subpart. Whey products to which § 58.806 General. approved ingredients have been added or constituents removed to alter origi- Dry storage of product, packaging nal characteristics for processing or room for bulk product, and hopper or usage shall be labeled to meet the ap- dump room shall meet the require- plicable requirements. ments of §§ 58.210 through 58.212 as ap- plicable. OPERATIONS AND OPERATING PROCEDURES EQUIPMENT AND UTENSILS § 58.809 Pasteurization. § 58.807 General construction, repair and installation. (a) All fluid whey used in the manu- All equipment and utensils necessary facture of dry whey, dry whey prod- for the manufacture of whey, whey ucts, modified whey products, and lac- products and lactose shall meet the tose shall be pasteurized prior to con- same general requirements for mate- densing. When the condensing and dry- rials and construction as outlined in ing operations for dry whey take place §§ 58.128 and 58.215 through 58.230 as ap- at the same plant, the pasteurization plicable, except for the following: may be located at a different point in (a) Modified Whey Products. Equip- the operation provided it will protect ment for whey fractionation, such as the quality of the finished product and ultrafiltration, reverse osmosis, gel fil- not adversely affect the processing pro- tration, and electrodialysis shall be cedure. constructed in accordance with 3–A (b) Pasteurized products transported sanitary design principles, except to another plant for final processing where engineering requirements pre- shall be repasteurized, except that con- clude strict adherence to such stand- densed whey containing 40 percent or ards. Materials used for product con- more solids may be transported to an- tact surfaces shall meet applicable 3–A other plant for further processing into Sanitary Standards or Food and Drug dry whey, dry whey products or lactose Administration requirements. All without repasteurization.
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(c) If whey is transferred to another SUPPLEMENTAL SPECIFICATIONS FOR plant for further processing, or if dur- PLANTS MANUFACTURING, PROCESSING, ing the processing procedure AND PACKAGING EVAPORATED AND unpasteurized ingredients are added CONDENSED MILK OR ULTRA-PASTEUR- (except those necessary for lactose IZED PRODUCTS crystallization), or processing proce- dures permit contamination or bac- DEFINITIONS terial growth, the whey shall be repas- teurized as close to the final drying op- § 58.905 Meaning of words. erations as possible. For the purpose of the regulations in this subpart, words in the singular § 58.810 Temperature requirements. form shall be deemed to impart the (a) Unless processed within 2 hours, plural and vice versa as the case may all whey or condensed whey, except demand. Unless the context otherwise acid type whey with a titratable acid- requires, the following terms shall ity of 0.40 percent or above, or a pH of have the following meaning: ° 4.6 or below, shall be cooled to 45 F or (a) Evaporated milk. The liquid food less, or heated to 145 °F or higher. made by evaporating sweet milk to Other temperatures may be used when such point that it contains not less essential for the technology of the than 7.5 percent of milkfat and not less process, such as lactose crystallization than 25.5 percent of the total milk sol- and membrane whey separation proc- ids. The finished product shall conform esses, when the quality and wholesome- to the requirements of § 18.520 ‘‘Defini- ness of the product is not impaired. (b) Recording thermometers shall be tions and Standards of Identity for required and so located to assure that Milk and Cream,’’ Food and Drug Ad- 1 the cooling or heating requirements in ministration (21 CFR 18.520). paragraph (a) of this section are met. (b) Concentrated milk, plain condensed milk. The product which conforms to § 58.811 General. the standard of identity for evaporated The operating procedures as con- milk except that it is not processed by tained in §§ 58.237 through 58.244, 58.246, heat to prevent spoilage. The container 58.247, and 58.443 (a) and (b) shall be fol- may be unsealed, and stabilizing ingre- lowed as applicable. dients are not used. The finished prod- uct shall conform to the requirements § 58.812 Methods of official sample of § 18.525 ‘‘Definitions and Standards of analysis. Identity for Milk and Cream,’’ Food Samples shall be tested according to and Drug Administration (21 CFR the applicable methods of laboratory 18.525).1 analysis contained in DA Instruction (c) Sweetened condensed milk. The liq- 918–109–2 and 918–109–3 as issued by the uid or semi-liquid food made by USDA, Agricultural Marketing Serv- evaporating a mixture of sweet milk ice, Poultry and Dairy Quality Divi- and refined sugar (sucrose) or any com- sion. bination of refined sugar (sucrose) and refined corn sugar (dextrose) to such (60 Stat. 1087, 7 U.S.C. 1621 et seq.; 84 Stat. point that the finished sweetened con- 1620, 21 U.S.C. 1031 et seq.) densed milk contains not less than 28.0 [40 FR 47911, Oct. 10, 1975. Redesignated at 42 percent of total milk solids and not FR 32514, June 27, 1977, as amended at 43 FR less than 8.5 percent of milkfat. The 60138, Dec. 26, 1978. Redesignated at 46 FR 63203, Dec. 31, 1981] quantity of sugar used is sufficient to prevent spoilage. The finished product REQUIREMENTS FOR FINISHED PRODUCTS shall conform to the requirements of BEARING USDA OFFICIAL IDENTIFICA- §§ 18.530 or 18.535, respectively, ‘‘Defini- TION tions and Standards of Identity for Milk and Cream,’’ Food and Drug Ad- § 58.813 Dry whey. ministration (21 CFR 18.530 and 18.535).1 The quality requirements for dry whey shall be in accordance with the 1 21 CFR Part 18 was redesignated as Part U.S. Standards for Dry Whey. 131 at 42 FR 14302, Mar. 15, 1977.
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(d) Ultra-pasteurized. The product minimize the number of damaged con- shall have been thermally processed at tainers. or above 280 °F for at least 2 seconds, either before or after packaging, so as § 58.916 Homogenizer. to produce a product which has an ex- Homogenizers where applicable shall tended shelf life under refrigerated be used to reduce the size of the fat conditions. particles and to evenly disperse them in the product. Homogenizers shall EQUIPMENT AND UTENSILS comply with the applicable 3–A Sani- § 58.912 General construction, repair tary Standards. and installation. OPERATIONS AND OPERATING The equipment and utensils used for PROCEDURES processing and packaging evaporated, condensed or ultra pasteurized dairy § 58.917 General. products shall be as specified in § 58.128. In addition for certain other equip- There are many operations and pro- ment, the following requirements shall cedures used in the preparation of be met. evaporated, condensed and ultra pas- teurized dairy products that are simi- § 58.913 Evaporators and vacuum lar, therefore, the following general re- pans. quirements will apply when such oper- All equipment used in the removal of ations or procedures are used. moisture from milk or milk products § 58.918 Standardization. for the purpose of concentrating the solids should comply with the require- The standardization of the product to ments of the 3–A Sanitary Standards obtain a finished product of a given for Milk and Milk Products Evapo- composition shall be accomplished by rators and Vacuum Pans. the addition or removal of milkfat, milk solids-not-fat and/or water. The § 58.914 Fillers. ingredients added to accomplish the Both gravity and vacuum type fillers desired composition shall be of the shall be of sanitary design and all prod- same hygenic quality as the product uct contact surfaces, if metal, shall be being standardized. made of stainless steel or equally cor- rosion-resistant material; except that, § 58.919 Pre-heat, pasteurization. certain evaporated milk fillers having When pasteurization is intended or brass parts may be approved if free required by either the vat method, from corroded surfaces and kept in HTST method, or by the HHST method good repair. Nonmetallic product con- it shall be accomplished by systems tact surfaces shall comply with the re- and equipment meeting the require- quirements for 3–A Sanitary Standards ments outlined in § 58.128. Pre-heat for Plastic, and Rubber and Rubber- temperatures prior to ultra pasteuriza- Like Materials. Fillers shall be de- tion will be those that have the most signed so that they in no way will con- favorable effect on the finished prod- taminate or detract from the quality of uct. the product being packaged. § 58.920 Homogenization. § 58.915 Batch or continuous in-con- tainer thermal processing equip- Where applicable concentrated prod- ment. ucts shall be homogenized for the pur- Shall comply with title 21, chapter 1, pose of dispersing the fat throughout subpart 128b—‘‘Thermally Processed the product. The temperature of the Low-Acid Foods Packaged in Hermeti- product at time of homogenization and cally Sealed Containers.’’ The equip- the pressure at which homogenization ment shall be maintained in such a is accomplished will be that which ac- manner as to assure control of the complishes the most desired results in length of time of processing, and to the finished products.
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§ 58.921 Concentration. § 58.926 Heat stability. Concentrating by evaporation shall Prior to thermal processing of con- be accomplished with a minimum of centrated products and where stabi- chemical change in the product. The lizers are allowed, tests should be made equipment and systems used shall in no on the heat stability of the product to way contaminate or adversely affect determine necessity for, and the the desirability of the finished product. amount of stabilizer needed. Based on the stability tests, safe and suitable § 58.922 Thermal processing. stabilizers and emulsifiers may be The destruction of living organisms added. shall be performed in one of the fol- lowing methods: (a) The complete in- § 58.927 Storage. container method, by heating the con- Finished products which are to be tainer and contents to a range of 212 °F held more than 30 days should be to 280 °F for a sufficient time; (b) by a stored at temperatures below 72 °F Pre- continuous flow process at or above 280 cautions shall be taken to prevent °F for at least 2 seconds, then packaged freezing of the product. aseptically; (c) the product is first processed according to methods as in § 58.928 Quality control tests. paragraph (b) of this section, then All dairy products and other ingredi- packaged and given further heat treat- ents shall be subject to inspection for ment to complete the process. quality and condition throughout each processing operation. Quality control § 58.923 Filling containers. tests shall be made on flow samples as (a) The filling of small containers often as is necessary to check the ef- with product shall be done in a sani- fectiveness of processing and manufac- tary manner. The containers shall not turing and as an aid in correcting defi- contaminate or detract from the qual- ciencies. Routine analyses shall be ity of the product in any way. After made on raw materials and finished filling, the container shall be hermeti- products to assure adequate composi- cally sealed. tion control. For each batch or produc- (b) Bulk containers for the product tion run a keeping quality test shall be shall be suitable and adequate to pro- made to determine product stability. tect the product in storage or transit. The bulk container (including bulk § 58.929 Frequency of sampling for tankers) shall be cleaned and sanitized quality control. before filling, and filled and closed in a (a) Composition. Sampling and testing sanitary manner. for composition shall be made on batches of product as often as is nec- § 58.924 Aseptic filling. essary to control composition. On con- A previously ultra pasteurized prod- tinuous production runs, enough sam- uct shall be filled under conditions ples shall be taken throughout the run which prevent contamination of the to adequately assure composition re- product by living organisms or spores. quirements. The containers prior to being filled (b) Other chemical analysis or physical shall be sterilized and maintained, in a analysis. Such tests shall be performed sterile condition. The containers shall as often as is necessary to assure com- be sealed in a manner that prevents pliance with standards, specifications contamination of the product. or contract requirements. (c) Weight or volume control. Rep- § 58.925 Sweetened condensed. resentative samples of the packaged After condensing, the sweetened con- products shall be checked during the densed product should be cooled rap- filling operation to assure compliance idly to about 85 °F to induce crys- with the stated net weight or volume tallization of the oversaturated lac- on the container. tose. When the desired crystallization (d) Keeping quality and stability. A is reached further cooling is resumed minimum of one sample from each to 68°–70 °F. batch of product or one representative
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sample per hour from a continuous pro- products shall be refined, and of food duction run shall be taken. For contin- grade quality. uous runs, samples shall be taken at the start, each hour, and at the end of § 58.935 Chocolate and cocoa. the run. Samples should also be taken Such products used as flavor ingredi- after resumption of processing fol- ents shall meet the requirements of the lowing an interruption in continuous Food and Drug Administration, ‘‘Defi- operation. Each sample shall be incu- nitions and Standards of Identity for bated at 90 °F to 100 °F for seven days. Cocoa Products.’’
§ 58.930 Official test methods. REQUIREMENTS FOR FINISHED PRODUCTS (a) Chemical. Chemical analysis, ex- BEARING USDA OFFICIAL IDENTIFICA- cept where otherwise prescribed herein, TION shall be made in accordance with the methods described in the latest edition § 58.936 Milk. of Official Methods of Analysis of the To process and package evaporated AOAC or by the latest edition of Stand- and condensed milk of ultra-pasteur- ard Methods for the Examination of ized dairy products eligible for official Dairy Products. identification with the USDA Quality (b) Microbiological. Microbiological Approved Inspection Shield the raw in- determinations shall be made in ac- coming milk shall meet the require- cordance with the methods described in ments as outlined in §§ 58.132 through the latest edition of Standard Methods 58.136. Unless processed within two for the Examination of Dairy Products. hours after being received, it shall be cooled to, and held at a temperature of § 58.931 General identification. 45 °F or lower until processed. Bulk shipping containers shall be leg- ibly marked with the name of the prod- § 58.937 Physical requirements for uct, net weight, name and address of evaporated milk. manufacturer, processor or distributor, (a) Flavor. The product shall possess a lot number and coded date of manu- a sweet, pleasing and desirable flavor facture. Consumer sized containers with not more than a definite cooked shall meet the applicable regulations flavor. It shall be free from scorched, of the Food and Drug Administration. oxidized or other objectionable tastes and odors. QUALITY SPECIFICATIONS FOR RAW (b) Body and texture. The product MATERIALS shall be of uniform consistency and ap- pearance. It shall be smooth and free § 58.932 Milk. from fat separation, lumps, clots, gel The raw milk shall meet the require- formation, coarse milk solids precipi- ments as outlined in §§ 58.132 through tate or sedimentation and extraneous 58.138. Unless processed within two material. hours after being received, it shall be (c) Color. The color shall be of a nat- cooled to, and held at a temperature of ural white or light cream. 45 °F or lower until processed. (d) Degree of burn-on. The interior walls of the container shall not show § 58.933 Stabilizers. excessive burn-on of product (product Shall be those permitted by the Food fused to more than 75 percent of the and Drug Administration’s ‘‘Standards inner surface of the can). of Identity’’ as optional ingredients for (e) Keeping quality. Samples incu- specific products. Stabilizers shall be bated at 90–100 °F shall show no sen- free from extraneous material, be of sory, chemical or microbiological dete- food grade quality and not be in viola- rioration after seven days. tion of the Federal Food, Drug and Cos- metic Act. § 58.938 Physical requirements and microbiological limits for sweet- § 58.934 Sugars. ened condensed milk. Any sugar used in the manufacture of (a) Flavor. Shall be sweet, clean, and sweetened condensed or sterilized milk free from rancid, oxidized, scorched,
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fermented, stale or other objectionable percent total milk solids, constitued of tastes and odors. not less than 10 percent milkfat. In no (b) Color. Shall be white to light case shall the content of milk solids cream. not fat be less than 6 percent. Whey (c) Texture. Shall be smooth and uni- shall not, by weight, be more than 25 form, free from lumps or coarse graini- percent of the milk solids not fat. ness. There shall not be sufficient set- (b) When one or more of the bulky tling of the lactose to cause a deposit optional ingredients, as approved by on the bottom of the container. the Food and Drug Administration, are (d) Body. Shall be sufficiently viscous used, the weights of milk fat and total so that the product upon being poured milk solids (excusive of such fat and at room temperature piles up above the surface of that previously poured, but solids in any malted milk used) are not does not retain a definite form. less than 10 percent and 20 percent, re- (e) Microbiological limits. (1) Coli- spectively, of the remainder obtained forms, less than 10 per gram; (2) yeasts, by subtracting the weight of such op- less than 5 per gram; (3) molds, less tional ingredients, from the weight of than 5 per gram; (4) total plate count, the finished ice cream; but in no case is less than 1,000 per gram. the weight of milk fat or total milk (f) Keeping quality. Samples incubated solids less than 8 percent and 16 per- at 90–100 °F shall show no physical evi- cent, respectively, of the weight of the dence of deterioration after seven days. finished ice cream. In calculating the (g) Composition. Shall meet the min- reduction of milk fat and total milk imum requirements as set forth in the solids from the use of bulky optional ‘‘Standards of Identity for Milk and ingredients, chocolate and cocoa solids Cream,’’ Food and Drug Administra- used shall be considered the bulky in- tion (21 CFR 18.530).1 In addition, the gredients. In order to make allowance quantity of refined sugar used shall be for additional sweetening ingredients sufficient to give a sugar-in-water ratio needed when bulky ingredients are of not less than 61.5 percent. used, the weight of chocolate or cocoa (h) Sediment. The amount of sediment solids may be multiplied by 2.5; the retained on a lintine disc after a sam- weight of fruit or nuts used may be ple composed of 225 grams of product multiplied by 1.4; and the weight of dissolved in 500 ml. of 140 °F water has passed through it, shall not exceed 0.10 partially or wholly dried fruits or fruit mg. as indicated by the USDA Sedi- juices may be multiplied by appro- ment Standard for Milk and Milk Prod- priate factors to obtain the original ucts (7 CFR 58.2726). weights before drying and this weight multiplied by 1.4 The finished ice Subparts C–V [Reserved] cream contains not less than 1.6 pounds to the gallon; except that when the op- tional ingredient microcrystalline cel- Subpart W—United States Depart- lulose is used, the finished ice cream ment of Agriculture Standard contains not less than 1.6 pounds of for Ice Cream total solids to the gallon and weighs not less than 4.5 pounds to the gallon SOURCE: 42 FR 56717, Oct. 28, 1977, unless exclusive, in both cases, of the weight otherwise noted. Redesignated at 46 FR 63203, of the microcrystalline cellulose. Dec. 31, 1981. (c) Optional characterizing ingredi- § 58.2825 United States Standard for ents, optional sweetening ingredients, ice cream. stabilizers, and emulsifiers as approved (a) Ice cream shall contain at least by the Food and Drug Administration 1.6 pounds of total solids to the gallon, may be used. weigh not less than 4.5 pounds to the § 58.2826 General identification. gallon, and contain not less than 20 Consumer packaged product shall 1 21 CFR parts 18 and 19 were redesignated comply with the applicable labeling as parts 131 and 133, respectively, at 42 FR regulations of the Food and Drug Ad- 14302, Mar. 15, 1977. ministration.
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§ 58.2827 Official identification. 59.303 Mandatory reporting of lamb car- casses and boxed lamb. (a) The official symbol to be used to identify product meeting the USDA Subpart E—OMB Control Number standard for ice cream shall be as fol- lows: 59.400 OMB control number assigned pursu- ant to the Paperwork Reduction Act.
AUTHORITY: 7 U.S.C. 1621 et seq.
SOURCE: 65 FR 75514, Dec. 1, 2000, unless otherwise noted.
EFFECTIVE DATE NOTE: At 65 FR 75514, Dec. 1, 2000 part 59 was added, effective January 30, 2001.
Subpart A—General Provisions § 59.10 General administrative provi- (b) Ice cream manufacturing plants sions. using this symbol shall be USDA ap- (a) Reporting by packers and importers. proved as set forth in subpart B of this A packer or importer shall report all regulation, and the ice cream bearing information required under this Part the symbol shall be manufactured on an individual lot basis. under continuous resident or contin- (b) Reporting schedule. Whenever a uous nonresident USDA inspection packer or importer is required to re- service in accordance with subpart A of port information on transactions of this regulation. The dairy ingredients livestock and livestock products under used in such ice cream shall come from this Part by a set time, all covered USDA approved plants. transactions up to within one half hour of the reporting deadline shall be re- PART 59—LIVESTOCK MANDATORY ported. Transactions completed during REPORTING the one half hour prior to the previous reporting time, but not reported in the Subpart A—General Provisions previous report, shall be reported at the next scheduled reporting time. Sec. (c) Regional reporting and aggregation. 59.10 General administrative provisions. The Secretary shall make information 59.20 Recordkeeping. 59.30 Definitions. obtained under this Part available to the public only in a manner that: Subpart B—Cattle Reporting (1) Ensures that the information is published on a national and a regional 59.100 Definitions. or statewide basis as the Secretary de- 59.101 Mandatory daily reporting for live termines to be appropriate; cattle. 59.102 Mandatory weekly reporting for live (2) Ensures that the identity of a re- cattle. porting person or the entity which 59.103 Mandatory reporting of boxed beef they represent is not disclosed; and sales. (3) Market information reported to the Secretary by packers and import- Subpart C—Swine Reporting ers shall be aggregated in such a man- 59.200 Definitions. ner that the market reports issued will 59.201 General reporting provisions. not disclose the identity of persons, 59.202 Mandatory daily reporting for swine. packers and importers, including par- 59.203 Mandatory weekly reporting for ties to a contract and packer’s and im- swine. porter’s proprietary information. (d) Adjustments. Prior to the publica- Subpart D—Lamb Reporting tion of any information required under 59.300 Definitions. this Part, the Secretary may make rea- 59.301 Mandatory daily reporting for lambs. sonable adjustments in information re- 59.302 Mandatory weekly reporting for ported by packers and importers to re- lambs. flect price aberrations or other unusual
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or unique occurrences that the Sec- (c) Purchases of lambs. A record of a retary determines would distort the purchase of a lot of lambs by a packer published information to the detriment shall evidence whether the purchase of producers, packers, or other market occurred: participants. (1) Before 2 p.m. Central Time; or (e) Reporting of activities on weekends (2) After 2 p.m. Central Time. and holidays. Livestock and livestock (d) Sales of lamb carcasses and sales of products committed to a packer, or im- boxed lamb cuts. A record of a sale by a porter, or purchased, sold, or slaugh- packer of lamb carcasses and cuts, or tered by a packer or importer on a of a sale by an importer of lamb cuts weekend day or holiday shall be re- shall evidence time and date the sale ported to the Secretary in accordance occurred: with the provisions of this Part and re- (1) Before 2 p.m. Central Time; or ported by the Secretary on the imme- (2) After 2 p.m. Central Time. diately following reporting day. A (e) Reporting sales of boxed beef cuts packer shall not be required to report and sales of boxed lamb cuts. such actions more than once on the im- (1) Beef packers must report all sales mediately following reporting day. of boxed beef items by the applicable (f) Reporting methods. Whenever infor- Institutional Meat Purchase Specifica- mation is required to be reported under tions (IMPS) item number or the boxed this Part, it shall be reported by elec- beef items’ cutting and trimming spec- tronic means and shall adhere to a ifications. standardized format established by the (2) Lamb packers and importers must Secretary to achieve the objectives of report all sales of boxed lamb items by this Part, except in emergencies or in the applicable Institutional Meat Pur- cases when an alternative method is chase Specifications (IMPS) item num- agreeable to the entity required to re- ber or the boxed lamb items’ cutting port and AMS. and trimming specifications.
§ 59.20 Recordkeeping. § 59.30 Definitions. (a) In General. Each packer or im- The following definitions apply to porter required to report information this part. to the Secretary under the Act and this Base price. The term ‘‘base price’’ Part shall maintain for 2 years and means the price paid for livestock, de- make available to the Secretary the livered at the packing plant, before ap- following information on request: plication of any premiums or dis- (1) The original contracts, agree- counts, expressed in dollars per hun- ments, receipts, and other records asso- dred pounds of hot carcass weight. ciated with any transaction relating to Basis level. The term ‘‘basis level’’ the purchase, sale, pricing, transpor- means the agreed on adjustment to a tation, delivery, weighing, slaughter, future price to establish the final price or carcass characteristics of all live- paid for livestock. stock or livestock products; and Current slaughter week. The term (2) Such records or other information ‘‘current slaughter week’’ means the as is necessary or appropriate to verify period beginning Monday, and ending the accuracy of the information re- Sunday, of the week in which a report- quired to be reported under the Act and ing day occurs. this Part. Discount. The term ‘‘discount’’ means (b) Purchases of cattle and swine and the adjustment, expressed in dollars sales of boxed beef cuts. A record of a per one hundred pounds, subtracted purchase of a lot of cattle or swine, or from the base price due to weight, a sale of a unit of boxed beef cuts, by quality characteristics, yield charac- a packer shall evidence whether the teristics, livestock class, dark cutting, purchase or sale occurred: breed, or dressing percentage. (1) Before 10 a.m. Central Time; Exported. The term ‘‘exported’’ means (2) Between 10 a.m. and 2 p.m. Cen- livestock or livestock products that tral Time; or (3) After 2 p.m. Central are physically shipped to locations out- Time. side of the 50 States.
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F.O.B. The term ‘‘F.O.B.’’ means free stock are scheduled for delivery to the on board, regardless of the mode of packer not more than 14 days after the transportation, at the point of direct date on which the livestock are com- shipment by the seller to the buyer mitted to the packer. (e.g., F.O.B. Plant, F.O.B. Feedlot). Negotiated sale. The term ‘‘negotiated Imported. The term ‘‘imported’’ sale’’ means a cash or spot market sale means livestock that are raised to by a producer of livestock to a packer slaughter weight outside of the 50 under which the base price for the live- States or livestock products produced stock is determined by seller-buyer outside of the 50 States. interaction and agreement on a deliv- Institutional meat purchase specifica- ery day. The livestock are scheduled tions. Specifications describing various for delivery to the packer not later meat cuts, meat products, and meat than 14 days after the date on which food products derived from all live- the livestock are committed to the stock species, commonly abbreviated packer. When used in reference to sales ‘‘IMPS’’, and intended for use by any of boxed beef or lamb cuts or lamb car- meat procuring activity. Copies of the casses the term ‘‘negotiated sale’’ IMPS may be obtained from the U.S. means a sale by a packer selling boxed Department of Agriculture, Agricul- beef or lamb cuts or lamb carcasses to tural Marketing Service, Livestock a buyer of boxed beef or lamb cuts or and Seed Program located at Room lamb carcasses under which the price 2603 South Building, 1400 Independence for the boxed beef or lamb cuts or lamb Ave, SW., PO Box 96456, Washington, carcasses is determined by seller-buyer DC 20090–6456. Phone (202) 720–4486 or interaction and agreement on a day. Fax (202) 720–1112. Copies may also be Origin. The term ‘‘origin’’ means the obtained over the Internet at: State where the livestock were fed to www.ams.usda.gov/lsg/stand/st-pubs.htm. slaughter weight. Livestock. The term ‘‘livestock’’ Premium. The term ‘‘premium’’ means cattle, swine, and lambs. means the adjustment, expressed in Lot. (1) When used in reference to dollars per one hundred pounds, added livestock, the term ‘‘lot’’ means a to the base price due to weight, quality group of one or more livestock that is characteristics, yield characteristics, identified for the purpose of a single livestock class, and breed. transaction between a buyer and a sell- Priced. The term ‘‘priced’’ means the er; time when the final price is determined (2) When used in reference to lamb either through buyer-seller interaction carcasses, the term ‘‘lot’’ means a and agreement or as a result of some group of one or more lamb carcasses other price determining method. sharing a similar weight range cat- Prior slaughter week. The term ‘‘prior egory and comprising a single trans- slaughter week’’ means the Monday action between a buyer and seller; or through Sunday prior to a reporting (3) When used in reference to boxed day. beef and lamb, the term ‘‘lot’’ means a Producer. The term ‘‘producer’’ group of one or more boxes of beef or means any person engaged in the busi- lamb items sharing cutting and trim- ness of selling livestock to a packer for ming specifications and comprising a slaughter (including the sale of live- single transaction between a buyer and stock from a packer to another pack- seller. er). Marketing. The term ‘‘marketing’’ Purchased. The term ‘‘purchased’’ means the sale or other disposition of means the agreement on a price, or the livestock, livestock products, or meat method for calculating a price, deter- or meat food products in commerce. mined through buyer-seller interaction Negotiated purchase. The term ‘‘nego- and agreement. tiated purchase’’ means a cash or spot Reporting day. The term ‘‘reporting market purchase by a packer of live- day’’ means a day on which a packer stock from a producer under which the conducts business regarding livestock base price for the livestock is deter- committed to the packer, or livestock mined by seller-buyer interaction and purchased, sold, or slaughtered by the agreement on a delivery day. The live- packer; the Secretary is required to
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make such information available to Cattle committed. The term ‘‘cattle the public; and the Department of Ag- committed’’ means cattle that are riculture is open to conduct business. scheduled to be delivered to a packer Secretary. The term ‘‘Secretary’’ within the 7-day period beginning on means the Secretary of Agriculture of the date of an agreement to sell the the United States or any other officer cattle. or employee of the Department of Agri- Cattle type. The term ‘‘cattle type’’ culture to whom authority has been means the following types of cattle delegated or may hereafter be dele- purchased for slaughter: gated to act in the Secretary’s stead. (1) Fed steers; State. The term ‘‘State’’ means each (2) Fed heifers; of the 50 States. (3) Fed Holsteins and other fed dairy steers and heifers; Subpart B—Cattle Reporting (4) Cows; and (5) Bulls. § 59.100 Definitions. Established. The term ‘‘established’’, The following definitions apply to when used in connection with prices, this subpart. means that point in time when the Boxed beef. The term ‘‘boxed beef’’ buyer and seller agree upon a net price. means those carlot-based portions of a Formula marketing arrangement. beef carcass including fresh primals, (1) When used in reference to live cat- subprimals, cuts fabricated from tle, the term ‘‘formula marketing ar- subprimals (excluding portion-control rangement’’ means the advance com- cuts such as chops and steaks similar mitment of cattle for slaughter by any to those portion cut items described in means other than through a negotiated the Institutional Meat Purchase Speci- purchase or a forward contract, using a fications (IMPS) for Fresh Beef Prod- method for calculating price in which ucts Series 100, and thin meats (e.g. in- the price is determined at a future side and outside skirts, pectoral meat, date. cap and wedge meat, and blade meat) (2) When used in reference to boxed not older than 14 days from date of beef, the term ‘‘formula marketing ar- manufacture; fresh ground beef, beef rangement’’ means the advance com- trimmings, and boneless processing mitment of boxed beef by any means beef not older than 7 days from date of other than through a negotiated pur- manufacture; and frozen beef trim- chase or a forward contract, using a mings and boneless processing beef not method for calculating price in which older than 60 days from date of manu- the price is determined at a future facture. date. Branded. The term ‘‘branded’’ means Forward contract. boxed beef cuts produced and marketed (1) When used in reference to live cat- under a corporate trademark (for ex- tle, the term ‘‘forward contact’’ means ample, products that are marketed on an agreement for the purchase of cat- their quality, yield, or breed character- tle, executed in advance of slaughter, istics), or boxed beef cuts produced and under which the base price is estab- marketed under one of USDA’s Meat lished by reference to prices quoted on Grading and Certification Branch, Cer- the Chicago Mercantile Exchange, or tified Beef programs. other comparable publicly available Carcass characteristics. The term ‘‘car- prices. cass characteristics’’ means the range (2) When used in reference to boxed and average carcass weight in pounds, beef, the term ‘‘forward contract’’ the quality grade and yield grade (if means an agreement for the sale of applicable), and the average cattle boxed beef, executed in advance of dressing percentage. manufacture, under which the base Carlot-based. The term ‘‘carlot-based’’ price is established by reference to means any transaction between a publicly available quoted prices. buyer and a seller destined for two or Packer. The term ‘‘packer’’ means less delivery stops consisting of one or any person engaged in the business of more individual boxed beef items. buying cattle in commerce for purposes
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of slaughter, of manufacturing or pre- were committed to the packer, the date paring meats or meat food products on which the cattle were purchased by from cattle for sale or shipment in the packer, or the date on which the commerce, or of marketing meats or cattle were priced by the packer. meat food products from cattle in an Type of purchase. The term ‘‘type of unmanufactured form acting as a purchase’’ with respect to cattle, wholesale broker, dealer, or distributor means a negotiated purchase, a for- in commerce. For any calendar year, mula market arrangement, and a for- the term ‘‘packer’’ includes only a fed- ward contract. erally inspected cattle processing plant Type of sale. The term ‘‘type of sale’’ that slaughtered an average of 125,000 with respect to boxed beef, means a ne- head of cattle per year during the im- gotiated sale, a formula market ar- mediately preceding 5 calendar years. rangement, and a forward contract. Additionally, in the case of a cattle processing plant that did not slaughter § 59.101 Mandatory daily reporting for cattle during the immediately pre- live cattle. ceding 5 calendar years, it shall be con- (a) In General. The corporate officers sidered a packer if the Secretary deter- or officially designated representatives mines the processing plant should be of each packer processing plant shall considered a packer under this subpart report to the Secretary at least two after considering its capacity. times each reporting day not later Packer-owned cattle. The term ‘‘pack- than 10:00 a.m. Central Time and not er-owned cattle’’ means cattle that a later than 2:00 p.m. Central Time the packer owns for at least 14 days imme- following information for each cattle diately before slaughter. type, inclusive since the last reporting, Prices for cattle. The term ‘‘prices for categorized to clearly delineate domes- cattle’’ includes the price per hundred- tic from imported market purchases as weight; the purchase type; the quan- described in § 59.10(b). tity on a live and a dressed weight (1) The prices for cattle (per hundred- basis; the estimated live weight range; weight) established on that day, cat- the average live weight; the estimated egorized by: percentage of cattle of a USDA quality (i) The type of purchase; grade Choice or better; beef carcass (ii) The quantity of cattle purchased classification; any premiums or dis- on a live weight basis; counts associated with weight, quality (iii) The quantity of cattle purchased grade, yield grade, or type of purchase; on a dressed weight basis; cattle State of origin; estimated cattle (iv) A range and average of estimated dressing percentage; and price basis as live weights of cattle purchased; F.O.B. feedlot or delivered at the plant. (v) An estimate of the percentage of Terms of trade. The term ‘‘terms of the cattle purchased that were of a trade’’ means, with respect to the pur- quality grade of Choice or better; and chase of cattle for slaughter: (vi) Any premiums or discounts asso- (1) Whether a packer provided any fi- ciated with weight, quality grade, or nancing agreement or arrangement yield grade expressed in dollars per with regard to the cattle; hundredweight on a dressed basis. (2) Whether the delivery terms speci- (2) The quantity of cattle delivered to fied the location of the producer or the the packer (quoted in numbers of head) location of the packer’s plant; on that day, categorized by: (3) Whether the producer is able to (i) The type of purchase; unilaterally specify the date and time (ii) The quantity of cattle delivered during the business day of the packer on a live weight basis; and that the cattle are to be delivered for (iii) The quantity of cattle delivered slaughter; and on a dressed weight basis. (4) The percentage of cattle pur- (3) The quantity of cattle committed chased by a packer as a negotiated pur- to the packer (quoted in numbers of chase that are delivered to the plant head) as of that day, categorized by: for slaughter more than 7 days, but (i) The type of purchase; fewer than 14 days, after the earlier of (ii) The quantity of cattle committed either the date on which the cattle on a live weight basis; and
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(iii) The quantity of cattle com- of the current slaughter week by 10:00 mitted on a dressed weight basis. a.m. Central Time. (4) The terms of trade regarding the cattle, as applicable. § 59.103 Mandatory reporting of boxed (b) Publication. The Secretary shall beef sales. make the information available to the (a) Daily reporting. The corporate offi- public not less frequently than three cers or officially designated represent- times each reporting day. atives of each packer processing plant shall report to the Secretary at least § 59.102 Mandatory weekly reporting twice each reporting day (once by 10 for live cattle. a.m. Central Time, and once by 2 p.m. (a) In General. The corporate officers Central Time) the following informa- or officially designated representatives tion on total boxed beef domestic and of each packer processing plant shall export sales established on that day in- report to the Secretary on the first re- clusive since the last reporting as de- porting day of each week, not later scribed in § 59.10(b): than 9:00 a.m. Central Time, the fol- (1) The price for each lot of each lowing information applicable to the boxed beef sale, quoted in dollars per prior slaughter week, categorized to hundredweight on a F.O.B. plant basis; clearly delineate domestic from im- (2) The quantity for each lot of each ported market purchases: sale, quoted by number of pounds sold; (1) The quantity of cattle purchased and through forward contracts that were (3) The information regarding the slaughtered; characteristics of each sale is as fol- (2) The quantity of cattle delivered lows: under a formula marketing arrange- (i) The type of sale; ment that were slaughtered; (ii) The branded product characteris- (3) The quantity and carcass charac- tics, if applicable; teristics of packer-owned cattle that (iii) The grade for steer and heifer were slaughtered; beef (e.g., USDA Prime, USDA Choice (4) The quantity, basis level, and de- or better, USDA Choice, USDA Select, livery month for all cattle purchased ungraded no-roll product); through forward contracts; (iv) The grade for cow beef or packer (5) The range and average of intended yield and/or quality sort for cow beef premiums and discounts (including (e.g., Breakers, Boners, White Cow); those associated with weight, quality (v) The cut of beef, referencing the grade, yield grade, or type of cattle) most recent version of the Institu- that are expected to be in effect for the tional Meat Purchase Specifications current slaughter week; and (IMPS), when applicable; (6) The following information for cat- (vi) The trim specification; tle purchased through a formula mar- (vii) The weight range of the cut; keting arrangement and slaughtered (viii) The product delivery period; during the prior slaughter week: and (i) The quantity (quoted in both num- (ix) The beef type (steer/heifer, dairy bers of head and pounds) of cattle; steer/heifer, or cow). (ii) The weighted average price paid (b) Publication. The Secretary shall for a carcass, including applicable pre- make available to the public the infor- miums and discounts; mation obtained under paragraph (a) of (iii) The range of premiums and dis- this section not less frequently than counts paid; twice each reporting day. (iv) The weighted average of pre- miums and discounts paid; (v) The range of prices paid; and Subpart C—Swine Reporting (vi) The terms of trade regarding the cattle, as applicable. § 59.200 Definitions. (b) Publication. The Secretary shall The following definitions apply to make available to the public the infor- this subpart. mation obtained under paragraph (a) of Affiliate. The term ‘‘affiliate’’, with this section on the first reporting day respect to a packer, means:
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(1) A person that directly or indi- the applicable reporting period, result- rectly owns, controls, or holds with ing from the fact that the swine did power to vote, 5 percent or more of the not fall within the individual packer’s outstanding voting securities of the established carcass weight range or lot packer; variation range. (2) A person 5 percent or more of Backfat. The term ‘‘backfat’’ means whose outstanding voting securities the fat thickness (in inches) measured are directly or indirectly owned, con- between the third and fourth rib from trolled, or held with power to vote, by the last rib, 7 centimeters from the the packer; and carcass split (or adjusted from the indi- (3) A person that directly or indi- vidual packer’s measurement to that rectly controls, or is controlled by or reference point using an adjustment under common control with, the pack- made by the Secretary) of the swine er. slaughtered during the applicable re- Applicable reporting period. The term porting period. ‘‘applicable reporting period’’ means Barrow. The term ‘‘barrow’’ means a the period of time prescribed by the neutered male swine, with the prior day report, the morning report, neutering performed before the swine and the afternoon report, as provided reached sexual maturity. in § 59.202. Base market hog. The term ‘‘base mar- Average carcass weight. The term ‘‘av- ket hog’’ means a hog for which no dis- erage carcass weight’’ means the counts are subtracted from and no pre- weight obtained by dividing the total miums are added to the base price. carcass weight of the swine slaughtered Base price. The term ‘‘base price’’ at the packing plant during the appli- means the price from which no dis- cable reporting period by the number counts are subtracted and no premiums of these same swine. are added. Average lean percentage. The term Boars. The term ‘‘boar’’ means a sex- ‘‘average lean percentage’’ means the ually-intact male swine. value equal to the average percentage of the carcass weight comprised of lean Bred female swine. The term ‘‘bred fe- meat for the swine slaughtered during male swine’’ means any female swine, the applicable reporting period. When- whether a sow or gilt, that has been ever the packer changes the manner in mated or inseminated, or has been con- which the average lean percentage is firmed, to be pregnant. calculated, the packer shall make Formula price. The term ‘‘formula available to the Secretary the under- price’’ means a price determined by a lying data, applicable methodology and mathematical formula under which the formulae, and supporting materials price established for a specified market used to determine the average lean per- serves as the basis for the formula. centage, which the Secretary may con- Gilt. The term ‘‘gilt’’ means a young vert either to the carcass measure- female swine that has not produced a ments or lean percentage of the swine litter. of the individual packer to correlate to Highest net price. The term ‘‘highest a common percent lean measurement. net price’’ means the highest net price Average net price. The term ‘‘average paid for a single lot or group of swine net price’’ means the quotient (stated slaughtered at a packing plant during per hundred pounds of carcass weight the applicable reporting period per of swine) obtained by dividing the total hundred pounds of carcass weight of amount paid for the swine slaughtered swine. at a packing plant during the applica- Hog Class. The term ‘‘hog class’’ ble reporting period (including all pre- means, as applicable, barrows or gilts; miums and less all discounts) by the sows; or boars or stags. total carcass weight of the swine (in Loin depth. The term ‘‘loin depth’’ hundred pound increments). means the muscle depth (in inches) Average sort loss. The term ‘‘average measured between the third and fourth sort loss’’ means the average discount ribs from the last rib, 7 centimeters (in dollars per hundred pounds carcass from the carcass split (or adjusted from weight) for swine slaughtered during the individual packer’s measurement
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to that reference point using an adjust- from swine for sale or shipment in ment made by the Secretary) of the commerce, or of marketing meats or swine slaughtered during the applica- meat food products from swine in an ble reporting period. unmanufactured form acting as a Lowest net price. The term ‘‘lowest wholesale broker, dealer, or distributor net price’’ means the lowest net price in commerce. For any calendar year, paid for a single lot or group of swine the term ‘‘packer’’ includes only a fed- slaughtered at a packing plant during erally inspected swine processing plant the applicable reporting period per that slaughtered an average of 100,000 hundred pounds of carcass weight of head of swine per year during the im- swine. mediately preceding 5 calendar years. Net price. The term ‘‘net price’’ Additionally, in the case of a swine means the total amount paid by a processing plant that did not slaughter packer to a producer (including all pre- swine during the immediately pre- miums, less all discounts) per hundred ceding 5 calendar years, it shall be con- pounds of carcass weight of swine de- sidered a packer if the Secretary deter- livered at the plant. The total amount mines the processing plant should be paid shall include any sum deducted considered a packer under this subpart from the price (per hundredweight) after considering its capacity. paid to a producer that reflects the re- Packer-owned swine. The term ‘‘pack- payment of a balance owed by the pro- er-owned swine’’ means swine that a ducer to the packer or the accumula- packer (including a subsidiary or affil- tion of a balance to later be repaid by iate of the packer) owns for at least 14 the packer to the producer. The total amount paid shall exclude any sum days immediately before slaughter. earlier paid to a producer that must be Packer-sold swine. The term ‘‘packer- repaid to the packer. sold swine’’ means the swine that are Noncarcass merit premium. The term owned by a packer (including a sub- ‘‘noncarcass merit premium’’ means an sidiary or affiliate of the packer) for increase in the base price of the swine more than 14 days immediately before offered by an individual packer or sale for slaughter; and sold for slaugh- packing plant, based on any factor ter to another packer. other than the characteristics of the Pork. The term ‘‘pork’’ means the carcass, if the actual amount of the meat of a porcine animal. premium is known before the sale and Pork product. The term ‘‘pork prod- delivery of the swine. uct’’ means a product or byproduct Other market formula purchase. The produced or processed in whole or in term ‘‘other market formula purchase’’ part from pork. means a purchase of swine by a packer Purchase data. The term ‘‘purchase in which the pricing mechanism is a data’’ means all of the applicable data, formula price based on any market including base price and weight (if pur- other than the market for swine, pork, chased live), for all swine purchased or a pork product. The term ‘‘other during the applicable reporting period, market formula purchase’’ includes a regardless of the expected delivery date formula purchase in a case which the of the swine, reported by: price formula is based on 1 or more fu- (1) Hog class; tures or options contracts. (2) Type of purchase; and Other purchase arrangement. The term (3) Packer-owned swine. ‘‘other purchase arrangement’’ means a purchase of swine by a packer that is Slaughter data. The term ‘‘slaughter not a negotiated purchase, swine or data’’ means all of the applicable data pork market formula purchase, or for all swine slaughtered by a packer other market formula purchase; and during the applicable reporting period, does not involve packer-owned swine. regardless of whether the price of the Packer. The term ‘‘packer’’ means swine was negotiated or otherwise de- any person engaged in the business of termined, reported by: buying swine in commerce for purposes (1) Hog class; of slaughter, of manufacturing or pre- (2) Type of purchase; and paring meats or meat food products (3) Packer-owned swine.
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Sow. The term ‘‘sow’’ means an adult (1) All purchase data, reported by lot, female swine that has produced 1 or including: more litters. (i) The total number of swine pur- Stag. The term ‘‘stag’’ means a male chased; swine that was neutered after reaching (ii) The total number of swine sched- sexual maturity. uled for delivery to a packer for Swine. The term ‘‘swine’’ means a slaughter; porcine animal raised to be a feeder (iii) The base price and weight for all pig, raised for seedstock, or raised for swine purchased on a live weight basis; slaughter. and Swine committed. The term ‘‘swine (iv) The base price and premiums and committed’’ means swine scheduled discounts paid for carcass characteris- and delivered to a packer within the 14- tics for all swine purchased on a car- day period beginning on the date of an cass basis for which a price has been es- agreement to sell the swine. tablished. For swine that were not Swine or pork market formula purchase. priced, this information shall be re- The term ‘‘swine or pork market for- ported on the next prior day report mula purchase’’ means a purchase of after the price is established. swine by a packer in which the pricing (2) The following slaughter data for mechanism is a formula price based on the total number of swine slaughtered: a market for swine, pork, or a pork (i) The average net price; product, other than a future or option (ii) The lowest net price; for swine, pork, or a pork product. (iii) The highest net price; Type of purchase. The term ‘‘type of (iv) The average carcass weight; purchase’’, with respect to swine, (v) The average sort loss; means: (vi) The average backfat; (1) A negotiated purchase; (vii) The average loin depth; (2) Other market formula purchase; (viii) The average lean percentage; (3) A swine or pork market formula and purchase; and (ix) Total quantity slaughtered. (4) Other purchase arrangement. (3) Packer purchase commitments, which shall be equal to the number of § 59.201 General reporting provisions. swine scheduled for delivery to a pack- (a) Packer-owned swine. Information er for slaughter for each of the next 14 required under this section for packer- calendar days. owned swine shall include quantity and (4) Publication. The Secretary shall carcass characteristics, but not price. publish the information obtained under (b) Type of Purchase. If information this paragraph in a prior day report not regarding the type of purchase is re- later than 8:00 a.m. Central Time on quired under this section, the informa- the reporting day on which the infor- tion shall be reported according to the mation is received from the packer. numbers and percentages of each type (b) Morning report. The corporate offi- of purchase comprising: cers or officially designated represent- (1) Packer-sold swine; and atives of each packer processing plant (2) All other swine. shall report to the Secretary not later than 10:00 a.m. Central Time each re- § 59.202 Mandatory daily reporting for porting day as described in § 59.10(b): swine. (1) The packer’s best estimate of the (a) Prior day report. The corporate of- total number of swine and packer- ficers or officially designated rep- owned swine expected to be purchased resentatives of each packer shall report throughout the reporting day through to the Secretary for each business day each type of purchase; of the packer not later than 7:00 a.m. (2) The total number of swine and Central Time on each reporting day in- packer-owned swine purchased up to formation regarding all swine pur- that time of the reporting day through chased, priced, or slaughtered during each type of purchase; the prior business day of the packer as (3) All purchase data for base market specified in § 59.10(b): hogs purchased up to that time of the
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reporting day through negotiated pur- § 59.203 Mandatory weekly reporting chases; and for swine. (4) All purchase data for base market (a) Weekly noncarcass merit premium hogs purchased through each type of report. Not later than 4:00 p.m. Central purchase other than negotiated pur- Time in accordance with § 59.10(b) on chase up to that time of the reporting the first reporting day of each week, day, unless such information is un- the corporate officers or officially des- available due to pricing that is deter- ignated representatives of each packer mined on a delayed basis. The packer processing plant shall report to the shall report information on such pur- Secretary a noncarcass merit premium chases on the first reporting day or report that lists: scheduled reporting time on a report- (1) Each category of standard noncar- ing day after the price has been deter- cass merit premiums used by the pack- mined. er in the prior slaughter week; and (5) Publication. The Secretary shall (2) The dollar value (in dollars per hundred pounds of carcass weight) paid publish the information obtained under to producers by the packer, by cat- this paragraph in the morning report egory. as soon as practicable, but not later (b) Premium list. A packer shall main- than 11 a.m. Central Time, on each re- tain and make available to a producer, porting day. on request, a current listing of the dol- (c) Afternoon report. The corporate of- lar values (per hundred pounds of car- ficers or officially designated rep- cass weight) of each noncarcass merit resentatives of each packer processing premium used by the packer during the plant shall report to the Secretary not current or the prior slaughter week. later than 2:00 p.m. Central Time each (c) Publication. The Secretary shall reporting day as described in § 59.10(b): publish the information obtained under (1) The packer’s best estimate of the this subsection as soon as practicable, total number of swine and packer- but not later than 5:00 p.m. Central owned swine expected to be purchased Time, on the first reporting day of each throughout the reporting day through week. each type of purchase; (2) The total number of swine and Subpart D—Lamb Reporting packer-owned swine purchased up to that time of the reporting day through § 59.300 Definitions. each type of purchase; The following definitions apply to (3) The base price paid for all base this subpart. market hogs purchased up to that time Boxed lamb. The term ‘‘boxed lamb’’ of the reporting day through nego- means those carlot-based portions of a tiated purchases; and lamb carcass including fresh primals, (4) The base price paid for all base subprimals, cuts fabricated from subprimals (excluding portion-control market hogs purchased through each cuts such as chops and steaks similar type of purchase other than negotiated to those portion cut items described in purchase up to that time of the report- the Institutional Meat Purchase Speci- ing day, unless such information is un- fications (IMPS) for Fresh Lamb and available due to pricing that is deter- Mutton Series 200, and thin meats (e.g. mined on a delayed basis. The packer inside and outside skirts, pectoral shall report information on such pur- meat, cap and wedge meat, and blade chases on the first reporting day or meat) not older than 14 days from date scheduled reporting time on a report- of manufacture; fresh ground lamb, ing day after the price has been deter- lamb trimmings, and boneless proc- mined. essing lamb not older than 7 days from (5) Publication. The Secretary shall date of manufacture; frozen primals, publish the information obtained under subprimals, cuts fabricated from this paragraph in the afternoon report subprimals, and thin meats not older as soon as practicable, but not later than 180 days from date of manufac- than 3:00 p.m. Central Time, on each ture; and frozen ground lamb, lamb reporting day. trimmings, and boneless processing
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lamb not older than 90 days from date price is established by reference to of manufacture. publicly available quoted prices. Branded. The term ‘‘branded’’ means Importer. The term ‘‘importer’’ means boxed lamb cuts produced and mar- any person engaged in the business of keted under a corporate trademark (for importing lamb meat products who example, products that are marketed takes ownership of such lamb meat on their quality, yield, or breed charac- products with the intent to sell or ship teristics), or boxed lamb cuts produced in U.S. commerce. For any calendar and marketed under one of USDA’s year, the term includes only those that Meat Grading and Certification imported an average of 5,000 metric Branch, Certified programs. tons of lamb meat products per year Carcass characteristics. The term ‘‘car- during the immediately preceding 5 cass characteristics’’ means the range calendar years. Additionally, the term and average carcass weight in pounds, includes those that did not import an the quality grade and yield grade (if average of 5,000 metric tons of lamb applicable), and the lamb average dressing percentage. meat products during the immediately Carlot-based. The term ‘‘carlot-based’’ preceding 5 calendar years, if the Sec- means any transaction between a retary determines that the person buyer and a seller destined for three or should be considered an importer based less delivery stops consisting of one or on their volume of lamb imports. more individual boxed lamb items or Lambs committed. The term ‘‘lambs any combination of carcass weights. committed’’ means lambs that are Established. The term ‘‘established’’, scheduled to be delivered to a packer when used in connection with prices, within the 7-day period beginning on means that point in time when the the date of an agreement to sell the buyer and seller agree upon a net price. lambs. Formula marketing arrangement. Packer. The term ‘‘packer’’ means (1) When used in reference to live any person engaged in the business of lambs, the term ‘‘formula marketing buying lambs in commerce for purposes arrangement’’ means the advance com- of slaughter, of manufacturing or pre- mitment of lambs for slaughter by any paring meat products from lambs for means other than through a negotiated sale or shipment in commerce, or of purchase or a forward contract, using a marketing meats or meat products method for calculating price in which from lambs in an unmanufactured form the price is determined at a future acting as a wholesale broker, dealer, or date. distributor in commerce. For any cal- (2) When used in reference to boxed endar year, the term includes only a lamb, the term ‘‘formula marketing ar- federally inspected lamb processing rangement’’ means the advance com- plant which slaughtered or processed mitment of boxed lamb by any means the equivalent of an average of 75,000 other than through a negotiated pur- head of lambs per year during the im- chase or a forward contract, using a mediately preceding 5 calendar years. method for calculating price in which the price is determined at a future Additionally, the term includes a lamb date. processing plant that did not slaughter Forward contract. or process an average of 75,000 lambs (1) When used in reference to live during the immediately preceding 5 lambs, the term ‘‘forward contact’’ calendar years if the Secretary deter- means an agreement for the purchase mines that the processing plant should of lambs, executed in advance of be considered a packer after consid- slaughter, under which the base price ering its capacity. is established by reference to publicly Packer-owned lambs. The term ‘‘pack- available prices. er-owned lambs’’ means lambs that a (2) When used in reference to boxed packer owns for at least 14 days imme- lamb, the term ‘‘forward contract’’ diately before slaughter. means an agreement for the sale of Terms of trade. The term ‘‘terms of boxed lamb, executed in advance of trade’’ includes, with respect to the manufacture, under which the base purchase of lambs for slaughter:
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(1) Whether a packer provided any fi- (viii) Lamb State of origin; nancing agreement or arrangement (ix) The pelt type; and with regard to the lambs; (x) The estimated lamb dressing per- (2) Whether the delivery terms speci- centage. fied the location of the producer or the (2) The quantity of lambs delivered to location of the packer’s plant; the packer (quoted in numbers of head) (3) Whether the producer is able to on that day, categorized by: unilaterally specify the date that the (i) The type of purchase; lambs are to be delivered for slaughter; (ii) The quantity of lambs delivered and on a live weight basis; and (4) The percentage of lambs pur- (iii) The quantity of lambs delivered chased by a packer as a negotiated pur- on a dressed weight basis. chase that are delivered to the plant (3) The quantity of lambs committed for slaughter more than 7 days, but less to the packer (quoted in numbers of than 14 days, after the earlier of either: head) as of that day, categorized by: (i) The date on which the lambs were (i) The type of purchase; committed to the packer; (ii) The quantity of lambs committed (ii) The date on which the lambs were on a live weight basis; and purchased by the packer; or (iii) The quantity of lambs com- (iii) The date on which the lambs mitted on a dressed weight basis. were priced by the packer. (4) The terms of trade regarding the Type of purchase. The term ‘‘type of lambs, as applicable. purchase’’ means a negotiated pur- (b) Publication. The Secretary shall chase, a formula market arrangement, make the information available to the and a forward contract. public not less than once each report- Type of sale. The term ‘‘type of sale’’ ing day. with respect to boxed lamb, means a negotiated sale, a formula market ar- § 59.302 Mandatory weekly reporting rangement, and a forward contract. for lambs. (a) In general. The corporate officers § 59.301 Mandatory daily reporting for or officially designated representatives lambs. of each packer processing plant shall (a) In general. The corporate officers report to the Secretary the following or officially designated representatives information applicable to the prior of each packer processing plant shall slaughter week contained in para- report to the Secretary at least once graphs (a)(1) through (a)(4) and (a)(6) of each reporting day not later than 2:00 this section not later than 9 a.m. Cen- p.m. Central Time the following infor- tral Time on the second reporting day mation for lamb, categorized to clearly of the current slaughter week, and the delineate domestic from imported mar- following information applicable to the ket purchases as described in § 59.10(b): prior slaughter week contained in para- (1) The prices for lambs (per hundred- graph (a)(5) of this section not later weight) established on that day as than 9:00 a.m. Central Time on the first F.O.B. feedlot or delivered at the plant, reporting day of the current slaughter categorized by: week categorized to clearly delineate (i) The type of purchase; domestic from imported market pur- (ii) The class of lamb; chases: (iii) The quantity of lambs purchased (1) The quantity of lambs purchased on a live weight basis; through forward contracts that were (iv) The quantity of lambs purchased slaughtered; on a dressed weight basis; (2) The quantity of lambs delivered (v) A range and average of estimated under a formula marketing arrange- live weights of lambs purchased; ment that were slaughtered; (vi) An estimate of the percentage of (3) The quantity and carcass charac- the lambs purchased that were of a teristics of packer-owned lambs that quality grade of Choice or better; were slaughtered; (vii) Any premiums or discounts as- (4) The quantity, basis level, and de- sociated with weight, quality grade, livery month for all lambs purchased yield grade, or any type of purchase; through forward contracts;
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(5) The following information appli- (iii) The USDA yield grade; cable to the current slaughter week. (iv) The estimated weight range of The range and average of intended pre- the carcasses; and miums and discounts (including those (v) The product delivery period. associated with weight, quality grade, (b) Daily reporting of domestic boxed yield grade, or type of lamb) that are lamb sales. The corporate officers or of- expected to be in effect for the current ficially designated representatives of slaughter week; and each packer shall report to the Sec- (6) The following information for retary each reporting day the following lambs purchased through a formula information on total domestic boxed marketing arrangement and slaugh- lamb cut sales not later than 2:30 p.m. tered during the prior slaughter week, Central Time as described in § 59.10(b): categorized to clearly delineate domes- (1) The price for each lot of each tic from imported market purchases: boxed lamb cut sale, quoted in dollars (i) The quantity (quoted in both num- per hundredweight on a F.O.B. plant bers of head and pounds) of lambs; basis; (ii) The weighted average price paid for a carcass, including applicable pre- (2) The quantity for each lot of each miums and discounts; sale, quoted by product weight sold; (iii) The range of premiums and dis- and counts paid; (3) The following information regard- (iv) The weighted average of pre- ing the characteristics of each trans- miums and discounts paid; action: (v) The range of prices paid; and (i) The type of sale; (vi) The terms of trade regarding the (ii) The branded product characteris- lambs, as applicable. tics, if applicable; (b) Publication. The Secretary shall (iii) The U.S.D.A. quality grade of make available to the public the infor- lamb; mation obtained under paragraphs (iv) The cut of lamb, referencing the (a)(1) through (a)(4) and (a)(6) of this most recent version of the Institu- section on the second reporting day of tional Meat Purchase Specifications the current slaughter week and infor- (IMPS), when applicable; mation obtained in paragraph (a)(5) of (v) U.S.D.A. yield grade, if applicable; this section on the first reporting day (vi) The product state of refrigera- of the current slaughter week. tion; (vii) The weight range of the cut; and § 59.303 Mandatory reporting of lamb carcasses and boxed lamb. (viii) The product delivery period. (c) (a) Daily reporting of lamb carcass Weekly reporting of imported boxed The corporate officers or of- transactions. The corporate officers or lamb sales. officially designated representatives of ficially designated representatives of each packer shall report to the Sec- each lamb importer shall report to the retary each reporting day the following Secretary on the first reporting day of information on total carlot-based lamb each week the following information carcass transactions not later than 3:00 applicable to the prior week for im- p.m. Central Time in accordance with ported boxed lamb cut sales not later § 59.10(b): than 10 a.m. Central Time: (1) The price for each lot of each (1) The price for each lot of a boxed lamb carcass transaction, quoted in lamb cut sale, quoted in dollars per dollars per hundredweight on an F.O.B. hundredweight on a F.O.B. plant basis; plant basis; (2) The quantity for each lot of a (2) The quantity for each lot of each transaction, quoted by product weight transaction, quoted by number of car- sold; and casses sold; and (3) The following information regard- (3) The following information regard- ing the characteristics of each trans- ing the characteristics of each trans- action: action: (i) The type of sale; (i) The type of sale; (ii) The branded product characteris- (ii) The USDA quality grade of lamb; tics, if applicable;
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(iii) The cut of lamb, referencing the LICENSED COTTONSEED SAMPLERS most recent version of the Institu- 61.25 Application for license as sampler; tional Meat Purchase Specifications form. (IMPS), when applicable; 61.27 Period of license; renewals. (iv) The product state of refrigera- 61.30 Examination of sampler. tion; 61.31 License must be posted. 61.32 No discrimination in sampling. (v) The weight range of the cut; and 61.33 Equipment of sampler; contents of cer- (vi) The product delivery period. tificate. (d) Publication. The Secretary shall 61.34 Drawing and preparation of sample. make available to the public the infor- 61.36 Cause for suspension or revocation. mation required to be reported in para- 61.37 License may be suspended. graphs (a) and (b) of this section not 61.38 Suspended license to be returned to Division. less frequently than once each report- 61.39 Duplicate license. ing day and the information required 61.40 Reports of licensed samplers. to be reported in paragraph (c) of this 61.41 Unlicensed persons must not represent section on the first reporting day of themselves as licensed samplers. the current slaughter week. 61.42 Information on sampling to be kept confidential.
Subpart E—OMB Control Number Subpart B—Standards for Grades of Cot- tonseed Sold or Offered for Sale for § 59.400 OMB control number assigned Crushing Purposes Within the United pursuant to the Paperwork Reduc- States tion Act. The information collection and rec- 61.101 Determination of grade. ordkeeping requirements of this part 61.102 Determination of quantity index. 61.103 Determination of quality index. have been approved by the Office of 61.104 Sampling and certification of samples Management and Budget (OMB) under and grades. the provisions of 44 U.S.C. Chapter 35 SOURCE: 22 FR 10948, Dec. 28, 1957, unless and have been assigned OMB Control otherwise noted. Number 0581–0186. Subpart A—Regulations PART 60 [RESERVED]
AUTHORITY: Sec. 205, 60 Stat. 1090, as PART 61—COTTONSEED SOLD OR amended, (7 U.S.C. 1624). OFFERED FOR SALE FOR CRUSH- ING PURPOSES (INSPECTION, DEFINITIONS SAMPLING AND CERTIFICATION) § 61.1 Words in singular form. Words used in the regulations in this Subpart A—Regulations subpart in the singular form shall be DEFINITIONS deemed to import the plural, and vice- versa, as the case may demand. Sec. 61.1 Words in singular form. § 61.2 Terms defined. 61.2 Terms defined. 61.2a Designation of official certificates, As used throughout the regulations memoranda, marks, other identifica- in this part, unless the context other- tions, and devices for purpose of the Ag- wise requires, the following terms shall ricultural Marketing Act. be construed, respectively to mean: (a) The act. The applicable provisions ADMINISTRATIVE AND GENERAL of the Agricultural Marketing Act of 61.3 Director. 1946 (60 Stat. 1087; 7 U.S.C. 1621 et seq.) 61.4 Supervisor of cottonseed inspection. or any other act of Congress conferring 61.5 Regulations to govern. like authority. 61.6 Denial of further services. (b) Regulations. Regulations mean the 61.7 Misrepresentation. provisions in this subpart. 61.8 Application for review. (c) Department. The United States De- 61.9 Cost of review. partment of Agriculture.
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(d) Secretary. The Secretary of Agri- (p) Dispute. A disagreement as to the culture of the United States, or any of- true grade of a sample of cottonseed ficer or employee of the Department to analyzed and graded by a licensed whom authority has heretofore been chemist. delegated, or to whom authority may (q) Party. A party to a dispute. hereafter be delegated, to act in his (r) Commercial laboratory. A chemical stead. laboratory operated by an individual, (e) Service. The Agricultural Mar- firm, or corporation in which one or keting Service of the United States De- more persons are engaged in the chem- partment of Agriculture. ical analysis of materials for the pub- (f) Administrator. The Administrator lic. of the Agricultural Marketing Service, (s) Cottonseed. The word ‘‘cottonseed’’ or any officer or employee of the Serv- as used in this part means the seed, ice, to whom authority has heretofore after having been put through the been delegated, or to whom authority usual and customary process known as may hereafter be delegated, to act in cotton ginning, of any cotton produced his stead. within the continental United States. (g) Division. The Cotton Division of (t) Lot. That parcel or quantity of the Agricultural Marketing Service. cottonseed offered for sale or tendered (h) Director. The Director of the Cot- for delivery or delivered on a sale or ton Division, or any officer or em- contract of sale, in freight cars, trucks, ployee of the Division to whom author- wagons, or otherwise in the quantities ity has heretofore been delegated, or to whom authority may hereafter be dele- and within the time limits prescribed gated, to act in his stead. from time to time by the Director for the drawing and preparation of official (i) Custodian. Person who has posses- sion or control of cottonseed or of sam- samples by licensed cottonseed sam- ples of cottonseed as agent, controller, plers. broker, or factor, as the case may be. (u) Official sample. A specimen of cot- (j) Owner. Person who through finan- tonseed drawn and prepared by a li- cial interest owns or controls, or has censed cottonseed sampler and cer- the disposition of either cottonseed or tified by him as representative of a cer- of samples of cottonseed. tain identified lot, in accordance with (k) Official cottonseed standards. The the regulations in this subpart. official standards of the United States [22 FR 10948, Dec. 28, 1957, as amended at 58 for the grading, sampling, and ana- FR 42413, Aug. 9, 1993] lyzing of cottonseed sold or offered for sale for crushing purposes. § 61.2a Designation of official certifi- (l) Supervisor of cottonseed inspection. cates, memoranda, marks, other An officer of the Division designated as identifications, and devices for pur- such by the Director. pose of the Agricultural Marketing Act. (m) License. A license issued under the act by the Secretary. Subsection 203(h) of the Agricultural (n) Licensed cottonseed chemist. A per- Marketing Act of 1946, as amended by son licensed under the act by the Sec- Pub. L. 272, 84th Congress, provides retary to make quantitative and quali- criminal penalties for various specified tative chemical analyses of samples of offenses relating to official certifi- cottonseed according to the methods cates, memoranda, marks, or other prescribed by the Science Division Di- identifications, and devices for making rector of the Agricultural Marketing such marks or identifications, issued or Service and to certificate the grade ac- authorized under section 203 of said cording to the official cottonseed act, and certain misrepresentations standards of the United States. concerning the inspection or grading of (o) Licensed cottonseed sampler. A per- agricultural products under said sec- son licensed by the Secretary to draw tion. For the purposes of said sub- and to certificate the authenticity of section and the provisions in this part, samples of cottonseed in accordance the terms listed below shall have the with the regulations in this subpart. respective meanings specified:
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(a) Official certificate means any form the Secretary or the Administrator of certification, either written or print- may require in enforcing the provisions ed, used under this part to certify with of the act and the regulations. respect to the inspection, sampling, class, grade, quality, quantity, or con- § 61.4 Supervisor of cottonseed inspec- dition of products (including the com- tion. pliance of products with applicable The Director, whenever he deems specifications). necessary, may designate an officer of (b) Official memorandum means any the Division as supervisor of cotton- initial record of findings made by an seed inspection who shall supervise the authorized person in the process of inspection and sampling of cottonseed grading, inspecting, or sampling, pur- and perform such other duties as may suant to this part, any processing or be required of him in administering the plant-operation report made by an au- act and the regulations. thorized person in connection with grading, inspecting, or sampling under § 61.5 Regulations to govern. this part, and any report made by an The inspection, sampling, analyzing, authorized person of services per- and grading of cottonseed in the United formed pursuant to this part. States pursuant to the act shall be per- (c) Official mark means the grade formed as prescribed in methods ap- mark, inspection mark, and any other proved from time to time by the Direc- mark, approved by the Administrator tor. and authorized to be affixed to any product, or affixed to or printed on the § 61.6 Denial of further services. packaging material of any product, Any person, partnership, or corpora- stating that the product was graded or tion that shall have undertaken to uti- inspected or both, or indicating the ap- lize the services of licensed cottonseed propriate U.S. grade or condition of the samplers under these regulations who product, or for the purpose or main- shall not make available for official taining the identity of products graded sampling and analysis each lot of cot- or inspected or both under this part. tonseed purchased or sold on grade and (d) Official identification means any received by such person or partnership United States (U.S.) standard designa- or corporation, may be denied further tion of class, grade, quality, quantity, services under the act and these regu- or condition specified in this part, or lations: Provided, That in cases of per- any symbol, stamp, label, or seal indi- sons, partnerships, or corporations op- cating that the product has been offi- erating two or more cottonseed crush- cially graded or inspected and/or indi- ing units under separate local manage- cating the class, grade, quality, quan- ments, such penalty shall apply only to tity, or condition of the product, ap- the offending unit, unless it shall be proved by the Administrator and au- shown that the actions of such unit thorized to be affixed to any product, were at the direction or with the or affixed to or printed on the pack- knowledge, approval, or acquiescence aging material of any product. of the general management. (e) Official device means a stamping [22 FR 10948, Dec. 28, 1957, as amended at 58 appliance, branding device, stencil, FR 42413, Aug. 9, 1993] printed label, or any other mechani- cally or manually operated tool that is § 61.7 Misrepresentation. approved by the Administrator for the Any willful misrepresentation or any purpose of applying any official mark deceptive or fradulent practice made or or other identification to any product committed by an applicant for a cot- or the packaging material thereof. tonseed sampler’s certificate or for a cottonseed chemist’s certificate or for ADMINISTRATIVE AND GENERAL an appeal grade certificate in connec- tion with the sampling or grading of § 61.3 Director. cottonseed by persons licensed under The Director shall perform for and the act and the regulations or the under the supervision of the Secretary issuance or use of a certificate not and the Administrator, such duties as issued by a person licensed under the
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regulations in imitation of or that grade certificate showing the true might mislead anyone to believe that grade of the cottonseed involved. such certificate was in fact issued by a [22 FR 10948, Dec. 28, 1957, Dec. 28, 1957, as person licensed under the act, or that amended at 58 FR 42413, Aug. 9, 1993] might be otherwise false, misleading, or deceptive, may be deemed sufficient § 61.9 Cost of review. cause for debarring such applicant In cases of review of the grade of any from any further benefits of the act. official sample of cottonseed, payment covering the costs of re-analysis shall § 61.8 Application for review. accompany the application. In case of dispute in which a review is desired of the grading of any official LICENSED COTTONSEED SAMPLERS sample of cottonseed covered by a valid § 61.25 Application for license as sam- certificate issued by a licensed cotton- pler; form. seed chemist, application therefor shall (a) Applications for licenses to sam- be filed with or mailed to a supervisor ple cottonseed shall be made to the Di- of cottonseed inspection within ten rector on forms furnished for the pur- days after the date of the original cer- pose by him. tificate, whereupon the licensed chem- (b) Each such application shall be in ist issuing the certificate shall imme- English, shall be signed by the appli- diately surrender to such supervisor cant, and shall contain or be accom- the retained portion of the original panied by (1) satisfactory evidence that sample, together with such records as he is an actual resident of the United may be required, for the determination States, (2) satisfactory evidence of his of the true grade. The supervisor shall experience in the handling and sam- assign to such retained portion an pling of cottonseed, (3) a statement by identification number, shall divide the applicant that he agrees to comply such retained portion into two parts with and abide by the terms of the act and submit the parts to two other li- and these regulations so far as they re- censed cottonseed chemists for rea- late to him, and with instructions nalysis. Should the supervisor deter- issued from time to time governing the mine that such reanalyses indicate a sampling of cottonseed, and (4) such grade differing from the original by not other information as may be required. more than plus or minus one full grade, § 61.27 Period of license; renewals. the original grade shall be considered the true grade. Should he find that The period for which a license may be such reanalyses indicate a grade dif- issued under the regulations in §§ 61.25 fering more than plus or minus one full through 61.42 shall be from the first grade from the original, he shall deter- day of August following receipt of the application, and shall continue for 5 mine the true grade. In any case, the years, ending on the 31st of July in the supervisor shall issue over his name an fifth year. Renewals shall be for 5 years appeal cottonseed grade certificate also, beginning with the first day of showing the true grade as determined August and ending on the 31st day of in accordance with this section, which July in the fifth year: Provided, That shall supersede the licensed chemists’ licenses or renewals issued on and after certificates relating to the grade of June 1 of any year shall be for the pe- such seed. Where due solely to errors in riod ending July 31 of the fifth year fol- calculation or clerical error a grade lowing. certificated by a licensed cottonseed chemist is not the true grade, the su- [59 FR 26411, May 20, 1994] pervisor shall direct the licensee to § 61.30 Examination of sampler. cancel the original and to issue a cor- Each applicant for a license as a sam- rect certificate. Should such error be pler and each licensed sampler when- found after an application for review ever requested by an authorized rep- has been filed, the supervisor shall nev- resentative of the Director, shall sub- ertheless issue an appeal cottonseed mit to an examination or test to show
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his ability properly to perform the du- conformity with instructions issued ties for which he is applying for a li- from time to time by the Division. cense or for which he has been licensed, and each such applicant or licensee § 61.34 Drawing and preparation of shall furnish the Division any informa- sample. tion requested at any time in regard to Each licensed cottonseed sampler his sampling of cottonseed. shall draw, prepare, and identify one official sample of cottonseed and a du- § 61.31 License must be posted. plicate thereof from each lot made Each licensed sampler shall keep his available to him in such manner as license conspicuously posted at the may be required by the Director, and place where he functions as a sampler shall promptly prepare it for for- or in such other place as may be ap- warding to a licensed cottonseed chem- proved by the Director. ist for analysis and grading. The dupli- cate shall be sealed and retained by the § 61.32 No discrimination in sampling. sampler until the original official sam- Each licensed sampler, when re- ple shall have been analyzed by a li- quested, shall without discrimination, censed chemist. If the original official as soon as practicable and upon reason- sample shall become lost or destroyed able terms, sample any cottonseed if before having been analyzed the dupli- the same be made available to him at cate shall become the official sample; his place of business, under conditions otherwise the licensed sampler shall that will permit proper sampling. Each immediately remove the identification such licensee shall give preference to marks from the duplicate and discard those who request his services as such it. In no case shall the duplicate be of- over persons who request his services fered for analysis unless the original in any other capacity. shall have been lost or destroyed before analysis. § 61.33 Equipment of sampler; contents of certificate. § 61.36 Cause for suspension or revoca- tion. Each licensed sampler shall have available suitable triers or sampling The failure or refusal of any cotton- tools, sample containers, scales, seed seed sampled, duly licensed as such cleaners, seed mixers, and air-tight under the regulations in this subpart, containers for enclosing and for- to draw, prepare, identify, and to for- warding the official samples to licensed ward an official sample of every lot of chemist, and with tags and samplers’ cottonseed made available to him for certificates approved or furnished by the purpose, in accordance with these the Director or his representative for regulations, shall be cause for the sus- identifying the samples of cottonseed pension or revocation of his license. A and for certificating the condition of sampler’s license may also be sus- the cottonseed represented by such pended when the sampler (a) has ceased samples. There shall be clearly written to perform services as a licensed cot- or printed on the face of such certifi- tonseed sampler, (b) has knowingly or cate (a) a suitable caption; (b) the loca- carelessly sampled cottonseed improp- tion of the cottonseed involved and its erly, (c) has violated or evaded any pro- point of origin; (c) the identification of vision of the Act, these regulations, or the lot from which the sample was the sampling methods prescribed by drawn; (d) the date on which the sam- the Director, (d) has used his license or ple was drawn; (e) the gross weight of allowed it to be used for any fraudulent the original sample, and the net weight or improper purposes, or (e) has in any of the cleaned sample; (f) a statement manner become incompetent or inca- indicating that the sample was drawn pacitated to perform the duties of a li- in accordance with sampling methods censed sampler. prescribed by the Director of the Cot- ton Division; and (g) the signature of § 61.37 License may be suspended. the licensed sampler as such. The use The Director may, without a hearing, of such tags and certificates shall be in suspend or revoke the license issued to
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a licensed sampler upon written re- § 61.41 Unlicensed persons must not quest and a satisfactory statement of represent themselves as licensed reasons therefor submitted by such li- samplers. censed sampler. Pending final action No person shall in any way represent by the Secretary, the Director may, himself to be a sampler licensed under whenever he deems such action nec- the act unless he holds an unsuspended essary, suspend the license of any li- and unrevoked license issued there- censed sampler by giving notice of such under. suspension to the licensee, accom- panied by a statement of the reasons § 61.42 Information on sampling to be therefor. Within 10 days after the re- kept confidential. ceipt of the aforesaid notice and state- Every person licensed under the act ment of reasons by such licensee, he as a sampler of cottonseed shall keep may file an appeal, in writing, with the confidential all information secured by Secretary, supported by any argument him relative to shipments of cotton- or evidence that he may wish to offer seed sampled by him. He shall not dis- as to why his license should not be sus- close such information to any person pended or revoked. After the expiration except an authorized representative of of the aforesaid 10-day period and con- the Department. sideration of such argument and evi- dence, the Secretary will take such ac- tion as he deems appropriate with re- Subpart B—Standards for Grades spect to such suspension or revocation. of Cottonseed Sold or Offered When no appeal is filed within the pre- for Sale for Crushing Purposes scribed 10 days, the license shall be Within the United States automatically revoked. AUTHORITY: Secs. 203, 205, 60 Stat. 1087, § 61.38 Suspended license to be re- 1090, as amended; 7 U.S.C. 1622, 1624. turned to Division. In case a license issued to a sampler § 61.101 Determination of grade. is suspended or revoked such license The grade of cottonseed shall be de- shall be returned to the Division. At termined from the analysis of samples the expiration of any period of suspen- by licensed chemists, and it shall be sion of such license, unless in the the result, stated in the nearest whole meantime it be revoked, the dates of or half numbers, obtained by multi- beginning and termination of such sus- plying a quantity index by a quality pension shall be endorsed thereon, it index and dividing the result by 100. shall be returned to the person to The quantity index and the quality whom it was originally issued, and its index shall be determined as herein- shall be posted as prescribed in § 61.31. after provided. (a) The basis grade of cottonseed § 61.39 Duplicate license. shall be grade 100. Upon satisfactory proof of the loss or (b) High grades of cottonseed shall be destruction of a license issued to a those grades above 100. sampler hereunder, a new license may (c) Low grades of cottonseed shall be be issued under the same or a new those grades below 100. number. (d) Grades for American Pima cotton- seed shall be suffixed by the designa- § 61.40 Reports of licensed samplers. tion ‘‘American Pima’’ or by the sym- Each licensed sampler, when re- bol ‘‘AP.’’ quested, shall make reports on forms [22 FR 10948, Dec. 28, 1957, as amended at 37 furnished for the purpose by the Divi- FR 20157, Sept. 27, 1972; 58 FR 42413, Aug. 9, sion bearing upon his activity as such 1993] licensee.
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§ 61.102 Determination of quantity 20.0 percent of moisture, or more than index. 25.0 percent of moisture and foreign The quantity index of cottonseed matter combined, shall be designated shall be determined as follows: as ‘‘off quality cottonseed.’’ (a) For upland cottonseed the quan- (d) Below grade cottonseed. Cottonseed tity index shall equal four times per- the grade of which when calculated ac- cording to § 61.101 is below grade 40.0 centage of oil plus six times percentage shall be designated as ‘‘below grade of ammonia, plus 5. cottonseed,’’ and a numerical grade (b) For American Pima cottonseed shall not be indicated. the quantity index shall equal four times percentage of oil, plus six times § 61.104 Sampling and certification of percentage of ammonia, minus 10. samples and grades. [37 FR 20157, Sept. 27, 1972] The drawing, preparation, and cer- tification of samples of cottonseed, and § 61.103 Determination of quality certification of grades of cottonseed index. shall be performed in accordance with The quality index of cottonseed shall methods approved from time to time be an index of purity and soundness, for the purposes by the Director, or his and shall be determined as follows: representatives. (a) Prime quality cottonseed. Cotton- [22 FR 10948, Dec. 28, 1957, as amended at 58 seed that by analysis contains not FR 42413, Aug. 9, 1993] more than 1.0 percent of foreign mat- ter, not more than 12.0 percent of mois- PART 70—VOLUNTARY GRADING ture, and not more than 1.8 percent of OF POULTRY PRODUCTS AND free fatty acids in the oil in the seed, shall be known as prime quality cot- RABBIT PRODUCTS tonseed and shall have a quality index Subpart A—Grading of Poultry Products of 100. and Rabbit Products (b) Below prime quality cottonseed. The quality index of cottonseed that, by GENERAL analysis, contain foreign matter, mois- Sec. ture, or free fatty acids in the oil in 70.1 Definitions. the seed, in excess of the percentages 70.2 Designation of official certificates, prescribed in paragraph (a) of this sec- memoranda, marks, other identifica- tion shall be found by reducing the tions, and devices for purposes of the Ag- quality index of prime quality cotton- ricultural Marketing Act. seed as follows: 70.3 Administration. 70.4 Grading services available. (1) Four-tenths of a unit for each 0.1 70.5 Nondiscrimination. percent of free fatty acids in the oil in 70.6 OMB control numbers assigned pursu- the seed in excess of 1.8 percent. ant to the Paperwork Reduction Act. (2) One-tenth of a unit for each 0.1 percent of foreign matter in excess of BASIS OF SERVICE 1.0 percent. 70.10 Grading service. (3) One-tenth of a unit for each 0.1 70.11 [Reserved] percent of moisture in excess of 12.0 70.12 Supervision. 70.13 Ready-to-cook poultry and rabbits and percent. specified poultry food products; eligi- (c) Off quality cottonseed. Cottonseed bility. that has been treated by either me- 70.14 Squabs and domesticated game birds; chanical or chemical process other eligibility. than the usual cleaning, drying, and 70.15 Equipment and facilities to be fur- ginning (except sterilization required nished for use of graders in performing by the United States Department of service on a resident basis. 70.16 Prerequisites to grading. Agriculture for quarantine purposes) or 70.17 Accessibility of products. that are fermented or hot, or that upon 70.18 Schedule of operation of official analysis are found to contain 12.5 per- plants. cent or more of free fatty acids in the oil in the seed, or more than 10.0 per- PERFORMANCE OF SERVICES cent of foreign matter, or more than 70.20 Licensed or authorized graders.
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70.21 Suspension of license; revocation. 70.81 Ready-to-cook poultry and rabbits and 70.22 Surrender of license. specified poultry food products. 70.23 Identification. 70.24 Financial interest of graders. GRADING CERTIFICATES 70.25 Political activity. 70.90 Forms. 70.91 Issuance and disposition. APPLICATION FOR GRADING SERVICE 70.92 Advance information. 70.30 Who may obtain grading service. 70.31 How application for service may be APPEAL OF A GRADING OR DECISION made; conditions of service. 70.100 Who may request an appeal grading 70.32 Filing of application. or review of a grader’s decision. 70.33 Authority of applicant. 70.101 Where to file an appeal. 70.34 Application for grading service in offi- 70.102 How to file an appeal. cial plants; approval. 70.103 When an application for an appeal 70.35 Rejection of application. grading may be refused. 70.36 Withdrawal of application. 70.104 Who shall perform the appeal. 70.37 Order of service. 70.105 Procedures for appeal gradings. 70.38 Suspension or withdrawal of plant ap- 70.106 Appeal grading certificates. proval for correctable cause. SANITARY REQUIREMENTS, FACILITIES, AND DENIAL OF SERVICE OPERATING PROCEDURES 70.40 Debarment. 70.110 Requirements for sanitation, facili- 70.41 Misrepresentation, deceptive, or fraud- ties, and operating procedures in official ulent acts or practices. plants. 70.42 Use of facsimile forms. 70.43 Willful violation of the regulations. SUBPARTS B–C[RESERVED] 70.44 Interfering with a grader or employee of Service. AUTHORITY: 7 U.S.C. 1621–1627. 70.45 Misleading labeling. SOURCE: 41 FR 23681, June 11, 1976, unless 70.46 Miscellaneous. otherwise noted. Redesignated at 42 FR 32514, June 27, 1977, and further redesignated at 46 IDENTIFYING AND MARKING PRODUCTS FR 63203, Dec. 31, 1981. 70.50 Approval of official identification and wording on labels. Subpart A—Grading of Poultry 70.51 Form of grademark and information required. Products and Rabbit Products 70.52 Prerequisites to packaging ready-to- cook poultry or rabbits identified with GENERAL consumer grademarks. 70.54 Retention authorities. § 70.1 Definitions. 70.55 Check grading officially identified Unless the context otherwise re- product. quires, the following terms shall have the following meaning: REPORTS Acceptable means suitable for the pur- 70.60 Report of grading work. pose intended and acceptable to the 70.61 Information to be furnished to grad- Service. ers. 70.62 Reports of violations. Act means the applicable provisions of the Agricultural Marketing Act of FEES AND CHARGES 1946 (60 Stat. 1087, as amended; 7 U.S.C. 70.70 Payment of fees and charges. 1621 et seq.) or any other act of Con- 70.71 On a fee basis. gress conferring like authority. 70.72 Fees for appeal grading, or examina- Administrator means the Adminis- tion or review of a grader’s decision. trator of the Agricultural Marketing 70.75 Travel expenses and other charges. Service of the Department or any other 70.76 Charges for continuous poultry grad- officer or employee of the Department ing performed on a nonresident basis. to whom there has heretofore been del- 70.77 Charges for continuous poultry or rab- egated or to whom there may hereafter bit grading performed on a resident basis. be delegated the authority to act in his 70.78 Fees or charges for grading service stead. performed under cooperative agreement. Applicant means any interested per- son who requests any grading service. GRADING Carcass means any poultry or rabbit 70.80 General. carcass.
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Chief of the Grading Branch means condition of any product by examining Chief of the Poultry Grading Branch, each unit thereof or each unit of the Poultry Division, Agricultural Mar- representative sample thereof drawn by keting Service. a grader, and issues a grading certifi- Class means any subdivision of a cate with respect thereto, except that product based on essential physical with respect to grading service per- characteristics that differentiate be- formed on a resident basis, the tween major groups of the same kind. issuance of a grading certificate shall Condition means any condition, in- be pursuant to a request therefor by cluding but not being limited to, the the applicant or the Service; (b) the act state of preservation, cleanliness, or whereby the grader identifies, accord- soundness of any product; or any condi- ing to the regulations in this part, the tion, including but not limited to the graded product; (c) with respect to any processing, handling, or packaging official plant, the act whereby a grader which affects such product. determines that the product in such Condition and wholesomeness means plant was processed, handled, and the condition of any product and its packaged in accordance with § 70.110, or healthfulness and fitness for human (d) any regrading or any appeal grading food. of a previously graded product. Department means the United States Grading certificate means a statement, Department of Agriculture. either written or printed, issued by a Free from protruding feathers or hairs grader, pursuant to the regulations in means that a poultry carcass, part, or this part, relative to the class, quality, poultry product with the skin on is free quantity, or condition of a product. from protruding feathers or hairs Holiday or Legal Holiday shall mean which are visible to a grader during an the legal public holidays specified by examination at normal operating the Congress in paragraph (a) of sec- speeds. However, a poultry carcass, tion 6103, title 5, of the United States part, or poultry product may be consid- Code. ered as being free from protruding feathers or hairs if it has a generally Identify means to apply official iden- clean appearance and if not more than tification to products or the containers an occasional protruding feather or thereof. hair is evidenced during a more careful Lightly shaded discolorations on poul- examination. try are generally reddish in color and Giblets means the following poultry are usually confined to areas of the organs when properly trimmed and skin or the surface of the flesh. washed: The liver from which the bile Moderately shaded discolorations on sac has been removed, the heart from poultry skin or flesh are areas that are which the pericardial sac has been re- generally dark red or bluish, or are moved, and the gizzard from which the areas of flesh bruising. Moderately lining and contents have been removed. shaded discolorations are free from With respect to rabbits ‘‘giblets’’ blood clots that are visible to a grader means the liver from which the bile sac during an examination of the carcass, has been removed and the heart from part, or poultry product at normal which the pericardial sac has been re- grading speeds. moved. National supervisor means (a) the offi- Grader means any Federal or State cer in charge of the poultry grading employee or the employee of a local ju- service of the Agricultural Marketing risdiction or cooperating agency to Service, and (b) other officers and em- whom a license has been issued by the ployees of the Department designated Secretary to investigate and certify in by the officer in charge of the poultry accordance with the regulations in this grading service of the Agricultural part the class, quality, quantity, or Marketing Service. condition of products. Office of grading means the office of Grading or grading service means: (a) any grader. The act whereby a grader determines, Official plant or official establishment according to the regulations in this means one or more buildings or parts part the class, quality, quantity, or thereof comprising a single plant in
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which the facilities and methods of op- moved, that is ready to cook without eration therein have been approved by need of further processing. Ready-to- the Administrator as suitable and ade- cook rabbit also means any cut-up or quate for grading service and in which disjointed portion of rabbit or any edi- grading is carried on in accordance ble part thereof. with the regulations in this part. Regional director means any employee Person means any individual, part- of the Department in charge of poultry nership, association, business trust, grading service in a designated geo- corporation, or any organized group of graphical area. persons, whether incorporated or not. Regulations means the provisions of Poultry means any kind of domes- this entire part and such United States ticated bird, including, but not being classes, standards, and grades for prod- limited to, chickens, turkeys, ducks, ucts as may be in effect at the time geese, pigeons, and guineas. grading is performed. Poultry food product means any arti- Secretary means the Secretary of the cle of human food or any article in- Department, or any other officer or tended for or capable of being so used, employee of the Department to whom which is prepared or derived in whole there has heretofore been delegated, or or in substantial part, from any edible to whom there may hereafter be dele- part or parts of poultry. gated, the authority to act in his stead. Poultry product means any ready-to- Service means the Agricultural Mar- cook poultry carcass or part therefrom keting Service of the Department. or any specified poultry food product. Slight discolorations on poultry skin Poultry grading service means the per- or flesh are areas of discoloration that sonnel who are actively engaged in the are generally pinkish in color and do administration, application, and direc- not detract from the appearance of the tion of poultry and rabbit grading pro- carcass, part, or poultry product. grams and services pursuant to the reg- Soundness means freedom from exter- ulations in this part. nal evidence of any disease or condi- Quality means the inherent prop- tion which may render a carcass or erties of any product which determine product unfit for food. its relative degree of excellence. State supervisor or Federal-State super- Rabbit means any domesticated rab- visor means any authorized and des- bit whether live or dead. ignated individual who is in charge of Rabbit product means any ready-to- the poultry grading service in a State. cook rabbit carcass or part therefrom. [41 FR 23681, June 11, 1976; 41 FR 24693, June Ready-to-cook poultry means any 18, 1976. Redesignated at 42 FR 32514, June 27, slaughtered poultry free from pro- 1977, as amended at 43 FR 60138, Dec. 26, 1978. truding feathers, vestigial feathers Redesignated at 46 FR 63203, Dec. 31, 1981, as (hair or down as the case may be) and amended at 47 FR 46071, Oct. 15, 1982; 47 FR from which the head, feet, crop, oil 54421, Dec. 3, 1982; 51 FR 17280, May 9, 1986; 60 FR 6639, Feb. 2, 1995; 63 FR 40628, July 30, gland, trachea, esophagus, entrails, 1998] mature reproductive organs, and lungs have been removed, and the kidneys § 70.2 Designation of official certifi- have been removed from certain ma- cates, memoranda, marks, other ture poultry as defined in 9 CFR part identifications, and devices for pur- 381, and with or without the giblets, poses of the Agricultural Marketing and which is suitable for cooking with- Act. out need of further processing. Ready- Subsection 203(h) of the Agricultural to-cook poultry also means any cut-up Marketing Act of 1946, as amended by or disjointed portion of poultry or Pub. L. 272, 84th Congress, provides other parts of poultry as defined in 9 criminal penalties for various specified CFR part 381 that are suitable for offenses relating to official certifi- cooking without need of further proc- cates, memoranda, marks, or other essing. identification and devices for making Ready-to-cook rabbit means any rabbit such marks or identifications, issued or which has been slaughtered for human authorized under section 203 of said food, from which the head, blood, skin, Act, and certain misrepresentations feet, and inedible viscera have been re- concerning the grading of agricultural
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products under said section. For the § 70.3 Administration. purposes of said subsection and the The Administrator shall perform for provisions in this part, the terms listed and under the supervision of the Sec- in this section shall have the respec- retary such duties as are prescribed in tive meaning specified: the regulations in this part and as the (a) Official certificate means any form Secretary may require in the adminis- of certification, either written or print- tration of the regulations in this part. ed, used under this part to certify with The Administrator is authorized to respect to the sampling, class, grade, waive for limited periods any par- quality, size, quantity, or condition of ticular provisions of the regulations to products (including the compliance of permit experimentation so that new products with applicable specifica- procedures and grading techniques may tions). be tested to facilitate definite improve- (b) Official memorandum means any ments and at the same time to deter- initial record of findings made by an mine full compliance with the spirit authorized person in the process of and intent of the regulations. The Ag- grading or sampling pursuant to this ricultural Marketing Service and its part, any processing or plant-operation officers and employees shall not be lia- report made by an authorized person in ble in damages through acts of com- connection with grading or sampling mission or omission in the administra- under this part, and any report made by an authorized person of services per- tion of this part. formed pursuant to this part. § 70.4 Grading services available. (c) Official mark means the grade- mark and any other mark, or any vari- The regulations in this part provide ations in such marks, approved by the for the following kinds of service; and Administrator and authorized to be af- any one or more of the different serv- fixed to any product or affixed to or ices applicable to official plants may printed on the packaging material of be rendered in an official plant: any product, stating that the product (a) Grading of ready-to-cook poultry was graded or indicating the appro- and rabbits in an official plant or at priate U.S. Grade or condition of the other locations with adequate facili- product, or for maintaining the iden- ties. tity of products graded under this part, (b) Grading of specified poultry food including but not limited to, those products in official plants. marks set forth in § 70.51. (d) Official identification means any § 70.5 Nondiscrimination. United States (U.S.) standard designa- The conduct of all services and the li- tion of class, grade, quality, size, quan- censing of graders and inspectors under tity, or condition specified in this part these regulations shall be accom- or any symbol, stamp, label, or seal in- plished without regard to race, color, dicating that the product has been offi- national origin, religion, age, sex, or cially graded and/or indicating the disability. class, grade, quality, size, quantity, or condition of the product approved by [60 FR 6640, Feb. 2, 1995] the Administrator and authorized to be § 70.6 OMB control numbers assigned affixed to any product, or affixed to or pursuant to the Paperwork Reduc- printed on the packaging material of tion Act. any product. (a) Purpose. This section collects and (e) Official device means a stamping appliance, branding device, stencil, displays the control numbers assigned printed label, or any other mechani- to information collection requirements cally or manually operated tool that is by the Office of Management and Budg- approved by the Administrator for the et contained in 7 CFR part 70 pursuant purpose of applying any official mark to the Paperwork Reduction Act of or other identification to any product 1980, Pub. L. 96–511. or the packaging material thereof. (b) Display.
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Current ice shall be rendered in accordance 7 CFR section where identified and described OMB control with instructions issued by the Admin- No. istrator where the facilities and condi- 70.3 ...... 0581Ð0127 tions are satisfactory for the conduct 70.10 ...... 0581Ð0127 70.17 ...... 0581Ð0127 of the service and the requisite graders 70.18 ...... 0581Ð0127 are available. Whenever the supervisor 70.20(a) ...... 0581Ð0127 of a grader has evidence that such 70.21 ...... 0581Ð0127 grader incorrectly graded a product, 70.31(a) ...... 0581Ð0127 70.31(b) ...... 0581Ð0127 such supervisor shall take such action 70.33 ...... 0581Ð0127 as is necessary to correct the grading 70.34 ...... 0581Ð0127 and to cause any improper grademarks 70.35 ...... 0581Ð0127 70.36 ...... 0581Ð0127 which appear on the product or con- 70.38(c) ...... 0581Ð0127 tainers thereof to be corrected prior to 70.38(d) ...... 0581Ð0127 shipment of the product from the place 70.40 ...... 0581Ð0127 70.50 ...... 0581Ð0127 of initial grading. 70.61 ...... 0581Ð0127 70.62 ...... 0581Ð0127 § 70.13 Ready-to-cook poultry and rab- 70.73 ...... 0581Ð0127 bits and specified poultry food 70.76(b)(1) ...... 0581Ð0127 70.76(b)(3)(ii) ...... 0581Ð0127 products; eligibility. 70.77(a)(1) ...... 0581Ð0127 Only ready-to-cook poultry and rab- 70.77(a)(4) ...... 0581Ð0127 70.77(b)(1) ...... 0581Ð0127 bits and specified poultry food products 70.77(b)(3)(ii) ...... 0581Ð0127 which are inspected and passed by the 70.91(a) ...... 0581Ð0127 poultry inspection service of the U.S. 70.91(c) ...... 0581Ð0127 70.92 ...... 0581Ð0127 Department of Agriculture or by any 70.100 ...... 0581Ð0127 other official inspection system accept- 70.102 ...... 0581Ð0127 able to the Department may be graded. 70.210(e) ...... 0581Ð0127 70.310(e) ...... 0581Ð0127 § 70.14 Squabs and domesticated game birds; eligibility. [48 FR 56566, Dec. 22, 1983, as amended at 51 FR 26224, July 22, 1986] Squabs and domesticated game birds (including, but not being limited to, BASIS OF SERVICE quail, pheasants, and wild species of ducks and geese raised in captivity) § 70.10 Grading service. may be graded under the regulations in Any grading service in accordance this part, only if they have been in- with the regulations in this part shall spected and passed by the poultry in- be for class, quality, quantity, or con- spection service of the U.S. Depart- dition or any combination thereof. ment of Agriculture or have been in- Grading service with respect to deter- spected by any other official inspection mination of quality of products shall system acceptable to the Department. be on the basis of United States class- es, standards, and grades as contained § 70.15 Equipment and facilities to be in subparts B and C of this part. How- furnished for use of graders in per- forming service on a resident basis. ever, grading service may be rendered with respect to products which are Such equipment and facilities shall bought and sold on the basis of institu- include but not be limited to: tional contract specifications or speci- (a) An accurate metal stem ther- fications of the applicant, and such mometer. service, when approved by the Adminis- (b) A drill with a steel bit to drill trator, shall be rendered on the basis of holes in frozen product for inserting such specifications. the metal thermometer stem to deter- mine temperature. § 70.11 [Reserved] (c) Scales graduated in tenths of a pound or less for weighing carcasses, § 70.12 Supervision. parts, or products individually or in All grading service shall be subject to containers up to 100 pounds, and test supervision at all times by the respon- weights for such scales. sible State supervisor, regional direc- (d) Scales graduated in one-pound tor, and national supervisor. Such serv- graduation or less for weighing bulk
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containers of poultry and test weights local jurisdiction, or the employee of a for such scales. cooperating agency possessing proper (e) Furnished adequate office space, a qualifications as determined by an ex- desk equipped with a satisfactory lock- amination for competency and who is ing device, lockers or cabinets suitable to perform grading service under this for the protection and storage of offi- part may be licensed by the Secretary cial supplies and facilities suitable for as a grader. graders to change clothing. (b) All licenses issued by the Sec- [41 FR 23681, June 11, 1976. Redesignated at 42 retary shall be countersigned by the of- FR 32514, June 27, 1977, and further redesig- ficer in charge of the poultry grading nated at 46 FR 63203, Dec. 31, 1981, as amend- service of the Agricultural Marketing ed at 51 FR 17280, May 9, 1986; 60 FR 6640, Service or any other designated officer Feb. 2, 1995] of such Service. § 70.16 Prerequisites to grading. (c) Any person who is employed by Grading of products shall be rendered any official plant and possesses proper pursuant to the regulations in this part qualifications as determined by the Ad- and under such conditions and in ac- ministrator may be authorized to grade cordance with such methods as may be poultry and/or rabbits on the basis of prescribed or approved by the Adminis- the U.S. classes, standards, and grades trator. under the supervision of a grader. No person to whom such authorization is § 70.17 Accessibility of products. granted shall have authority to issue Each product for which grading serv- any grading certificates, grading ice is requested shall be so placed as to memoranda, or other official docu- disclose fully its class, quality, quan- ments; and all products graded by any tity, and condition as the cir- such person shall thereafter be check cumstances may warrant. graded by a grader.
§ 70.18 Schedule of operation of offi- § 70.21 Suspension of license; revoca- cial plants. tion. Grading operation schedules for serv- Pending final action by the Sec- ices performed pursuant to §§ 70.76 and retary, any person authorized to coun- 70.77 shall be requested in writing and tersign a license to perform grading be approved by the Administrator. Nor- service may, whenever he deems such mal operating schedules for a full week consist of a continuous 8-hour period action necessary to assure that any per day (excluding not to exceed 1 hour grading services are properly per- for lunch), 5 consecutive days per week, formed, suspend any license to perform within the administrative workweek, grading service issued pursuant to this Sunday through Saturday, for each part, by giving notice of such suspen- shift required. Less than 8-hour sched- sion to the respective licensee, accom- ules may be requested and will be ap- panied by a statement of the reasons proved if a grader is available. Clock therefor. Within 7 days after the re- hours of daily operations need not be ceipt of the aforesaid notice and state- specified in the request, although as a ment of reasons, the licensee may file condition of continued approval, the an appeal in writing, with the Sec- hours of operation shall be reasonably retary, supported by any argument or uniform from day to day. Graders are evidence that he may wish to offer as to be notified by management 1 day in to why his license should not be fur- advance of any change in the hours ther suspended or revoked. After the grading service is requested. expiration of the aforesaid 7–day period [48 FR 20683, May 9, 1983] and consideration of such argument and evidence, the Secretary will take PERFORMANCE OF SERVICES such action as he deems appropriate with respect to such suspension or rev- § 70.20 Licensed or authorized graders. ocation. When no appeal is filed within (a) Any person who is a Federal or the prescribed 7 days, the license to State employee, the employee of a perform grading service is revoked.
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§ 70.22 Surrender of license. § 70.31 How application for service may be made; conditions of service. Each license which is suspended or revoked shall immediately be surren- (a) Noncontinuous grading service on a dered by the licensee to the office of fee basis. An application for any non- grading serving the area in which he is continuous grading service on a fee located. Upon termination of the serv- basis may be made in any office of grading or with any grader at or near- ices of a licensed grader, the licensee est the place where the service is de- shall surrender his license immediately sired. Such application may be made for cancellation. orally (in person or by telephone), in writing, or by telegraph. If the applica- § 70.23 Identification. tion for grading service is made orally, Each grader shall have in his posses- the office of grading or the grader with sion at all times, and present upon re- whom such application is made or the quest while on duty, the means of iden- Administrator may require that the tification furnished by the Department application be confirmed in writing. to such person. (b) Continuous grading service on a resident basis or continuous grading serv- § 70.24 Financial interest of graders. ice on a nonresident basis. An applica- No grader shall render service on any tion for continuous grading service on a resident basis or for continuous grad- product in which he is financially in- ing service on a nonresident basis must terested. be made in writing on forms approved by the Administrator and filed with § 70.25 Political activity. the Administrator. Such forms may be All graders are forbidden, during the obtained at the national, regional, or period of their respective appointments State grading office. In making appli- or licenses, to take an active part in cation, the applicant agrees to comply political management or in political with the terms and conditions of the campaigns. Political activity in city, regulations (including, but not being county, State, or national elections, limited to, such instructions governing whether primary or regular, or in be- grading of products as may be issued half of any party or candidate, or any from time to time by the Adminis- measure to be voted upon, is prohib- trator). No member of or Delegate to ited. This applies to all appointees, in- Congress or Resident Commissioner cluding, but not being limited to, tem- shall be admitted to any benefit that porary and cooperative employees and may arise from such service unless de- employees on leave of absence with or rived through service rendered a cor- without pay. Willful violation of this poration for its general benefit. section will constitute grounds for dis- § 70.32 Filing of application. missal in the case of appointees and An application for grading service revocation of licenses in the case of li- shall be regarded as filed only when censees. made pursuant to the regulations in [41 FR 23681, June 11, 1976. Redesignated at 42 this part. FR 32514, June 27, 1977, and further redesig- nated at 46 FR 63203, Dec. 31, 1981, as amend- § 70.33 Authority of applicant. ed at 48 FR 20683, May 9, 1983] Proof of the authority of any person applying for grading service may be re- APPLICATION FOR GRADING SERVICE quired at the discretion of the Admin- istrator. § 70.30 Who may obtain grading serv- ice. § 70.34 Application for grading service An application for grading service in official plants; approval. may be made by any interested person, Any person desiring to process and including, but not being limited to, the pack products in a plant under grading United States, any State, county, mu- service must receive approval of such nicipality, or common carrier, and any plant and facilities as an official plant authorized agent of the foregoing. prior to the rendition of such service.
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An application for grading service to be tion. Within 20 days following the re- rendered in an official plant shall be ceipt of such a petition for reconsider- approved according to the following ation, the Administrator shall approve procedure: Survey. When application the application or notify the applicant has been filed for grading service, as by registered mail of the reasons for aforesaid, the State supervisor or his the rejection thereof. assistant shall examine the grading of- fice, facilities, and equipment and § 70.36 Withdrawal of application. specify any additional facilities or Any application for grading service equipment needed for the service. may be withdrawn by the applicant at When the plant survey for poultry or any time before the service is per- rabbit grading has been completed and formed upon payment by the applicant, approved in accordance with the regu- of all expenses incurred by the Service lations in this part, service may be in- in connection with such application. stalled. § 70.37 Order of service. § 70.35 Rejection of application. Grading service shall be performed, Any application for grading service insofar as practicable and subject to may be rejected by the Administrator the availability of qualified graders, in (a) whenever the applicant fails to the order in which applications there- meet the requirements of the regula- for are made, except that precedence tions prescribing the conditions under may be given to any application for an which the service is made available; (b) appeal grading. whenever the product is owned by or located on the premises of a person § 70.38 Suspension or withdrawal of currently denied the benefits of the plant approval for correctable Act; (c) where any individual holding cause. office or a responsible position with or (a) Any plant approval given pursu- having a substantial financial interest ant to the regulations in this part may or share in the applicant, is currently be suspended by the Administrator for denied the benefits of the Act, or was (1) failure to maintain grading facili- responsible in whole or in part for the ties and equipment in a satisfactory current denial of the benefits of the state of repair, sanitation, or cleanli- Act to any person; (d) where the Ad- ness; (2) the use of operating proce- ministrator determines that the appli- dures which are not in accordance with cation is an attempt on the part of a the regulations in this part; or (3) al- person currently denied the benefits of terations of grading facilities or equip- the Act to obtain grading service; (e) ment which have not been approved in whenever the applicant, after an initial accordance with the regulations in this survey has been made in accordance part. with § 70.34, fails to bring the grading (b) Whenever it is feasible to do so, facilities and equipment into compli- written notice in advance of a suspen- ance with the regulations within a rea- sion shall be given to the person con- sonable period of time; or (f) notwith- cerned and shall specify a reasonable standing any prior approval whenever, period of time in which corrective ac- before inauguration of service, the ap- tion must be taken. If advance written plicant fails to fulfill commitments notice is not given, the suspension ac- concerning the inauguration of the tion shall be promptly confirmed in service. Each such applicant shall be writing and the reasons therefor shall promptly notified by registered mail of be stated, except in instances where the reasons for the rejection. A written the person has already corrected the petition for reconsideration of such re- deficiency. Such service, after appro- jection may be filed by the applicant priate corrective action is taken, will with the Administrator if postmarked be restored immediately, or as soon or delivered within 10 days after re- thereafter as a grader can be made ceipt of notice of the rejection. Such available. During such period of sus- petition shall state specifically the er- pension, grading service shall not be rors alleged to have been made by the rendered. However, the other provi- Administrator in rejecting the applica- sions of the regulations pertaining to
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providing service on a resident basis subpart H) shall be applicable to such will remain in effect unless such serv- debarment action. ice is terminated in accordance with [41 FR 23681, June 11, 1976. Redesignated at 42 the provisions of this part. FR 32514, June 27, 1977, as amended at 43 FR (c) If the grading facilities or meth- 60139, Dec. 26, 1978. Redesignated at 46 FR ods of operation are not brought into 63203, Dec. 31, 1981] compliance within a reasonable period § 70.41 Misrepresentation, deceptive, of time as specified by the Adminis- or fraudulent acts or practices. trator, he shall initiate withdrawal ac- tion pursuant to the Rules of Practice Any willful misrepresentation or any deceptive or fraudulent act or practice Governing Withdrawal of Inspection found to be made or committed by any and Grading Service (7 CFR part 1, sub- person in connection with: part H), and the operator shall be af- (a) The making or filing of any appli- forded an opportunity for an oral hear- cation for any grading service, appeal ing upon his written request in accord- or regrading service; ance with such Rules of Practice, with (b) The making of the product acces- respect to the merits or validity of the sible for grading; withdrawal action, but any suspension (c) The making, issuing, or using, or shall continue in effect pending the attempting to issue or use any grading outcome of such hearing unless other- certificate, symbol, stamp, label, seal, wise ordered by the Administrator. or identification, authorized pursuant Upon withdrawal of grading service in to the regulations in this part; an official plant, the plant approval (d) The use of the terms ‘‘United shall also become terminated, and all States’’ or ‘‘U.S.’’ in conjunction with labels, seals, tags, or packaging mate- the grade of the product; rial bearing official identification (e) The use of any of the aforesaid shall, under the supervision of a person terms or any official stamp, symbol, designated by the service, either be de- label, seal, or identification in the la- stroyed, or the official identification beling or advertising of any product. completely obliterated, or sealed in a [41 FR 23681, June 11, 1976; 41 FR 24693, June manner acceptable to the service. 18, 1976. Redesignated at 42 FR 32514, June 27, (d) In any case where grading service 1977, and further redesignated at 46 FR 63203, Dec. 31, 1981] is withdrawn under this § 70.38, the per- son concerned may thereafter apply for § 70.42 Use of facsimile forms. grading service as provided in §§ 70.30 Using or attempting to use a form through 70.37 of these regulations. which simulates in whole or in part [41 FR 23681, June 11, 1976. Redesignated at 42 any certificate, symbol, stamp, label, FR 32514, June 27, 1977, as amended at 43 FR seal, or identification authorized to be 60139, Dec. 26, 1978. Redesignated at 46 FR issued or used under the regulations in 63203, Dec. 31, 1981] this part.
DENIAL OF SERVICE § 70.43 Willful violation of the regula- tions. § 70.40 Debarment. Any willful violation of the regula- The acts or practices set forth in tions in this part or the Act. §§ 70.41 through 70.46, or the causing thereof, may be deemed sufficient § 70.44 Interfering with a grader or employee of Service. cause for the debarment by the Admin- istrator of any person, including any Any interference with or obstruction agents, officers, subsidiaries, or affili- or any attempted interference or ob- ates of such person, from any or all struction of, or assault upon any grad- benefits of the Act for a specified pe- er, licensee, or employee of the Service in the performance of his duties. The riod. The rules of practice governing giving or offering, directly or indi- withdrawal of grading services in for- rectly, of any money, loan, gift, or any- mal adjudicatory proceedings insti- thing of value to an employee of the tuted by the Secretary (7 CFR, part 1, Service, or the making or offering of
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any contribution to or in any way be the official identification symbol for supplementing the salary, compensa- purposes of this part and when used, tion, or expenses of an employee of the imitated, or simulated in any manner Service, or the offering or entering into in connection with poultry or rabbits, a private contract or agreement with shall be deemed prima facia to con- an employee of the Service for any stitute a representation that the prod- services to be rendered while employed uct has been officially graded for the by the Service. purposes of § 70.2. (2) Except as otherwise authorized, § 70.45 Misleading labeling. the grademark permitted to be used to The use of the terms ‘‘Government officially identify USDA consumer- Graded’’ and ‘‘Federal-State Graded’’ graded poultry and rabbit products or terms of similar import in the label- shall be of the form and design indi- ing or advertising of any product with- cated in Figures 2 through 4 of this sec- out stating in the labeling or advertise- tion. The shield shall be of sufficient ment the U.S. grade of the product as size so that the printing and other in- determined by an authorized grader. formation contained therein is legible and in approximately the same propor- § 70.46 Miscellaneous. tion as shown in these figures. The existence of any of the condi- (3) The ‘‘Prepared From’’ grademark tions set forth in § 70.35 constituting a in Figure 5 of this section may be used basis for the rejection of an application to identify specialized poultry products for grading service. for which there are no official U.S. grade standards, provided that these IDENTIFYING AND MARKING PRODUCTS products are approved by the Agency § 70.50 Approval of official identifica- and are prepared from U.S. Consumer tion and wording on labels. Grade A poultry carcasses, parts, or other products that comply with the Any label or packaging material requirements of AMS § 70.220. All poul- which bears any official grade identi- fication shall be used only in such a try products shall be processed and la- manner as the Administrator may pre- beled in accordance with 9 CFR part scribe, and such labeling or packaging 381. materials, including the wording used (b) Information required on grademark. on such materials, shall be approved in (1) Except as otherwise authorized by accordance with and conform with the the Administrator, each grademark provisions of this part 70 and the appli- used shall include the letters ‘‘USDA’’ cable provisions of §§ 381.115 through and the U.S. grade of the product it 381.141 of 9 CFR part 381. Poultry Prod- identifies, such as ‘‘A Grade,’’ as shown ucts Inspection Regulations. Labeling in Figure 2 of this section. Such infor- requirements for ready-to-cook rabbits, mation shall be printed with the shield except for the product name, shall be and the wording within the shield in the same as for ready-to-cook poultry. contrasting colors in a manner such For ready-to-cook rabbits the class that the design is legible and con- name shall be shown on the label. The spicuous on the material upon which it appropriate designation, ‘‘young,’’ is printed. ‘‘mature,’’ or ‘‘old,’’ may be used as a (2) Except as otherwise authorized, prefix to the word ‘‘rabbit’’ in lieu of the bands of the shield in Figure 4 of the class name. this section shall be displayed in three colors, with the color of the top, mid- [41 FR 23681, June 11, 1976; 41 FR 24694, June 18, 1976. Redesignated at 42 FR 32514, June 27, dle, and bottom bands being blue, 1977, and further redesignated at 46 FR 63203, white, and red, respectively. Dec. 31, 1981] (3) The ‘‘Prepared From’’ grademark in Figure 5 of this section may be any § 70.51 Form of grademark and infor- one of the designs shown in Figures 2 mation required. through 4 of this section. The text out- (a) Form of official identification sym- side the shield shall be conspicuous, bol and grademark. (1) The shield set legible, and in approximately the same forth in Figure 1 of this section shall proportion and close proximity to the
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shield as shown in Figure 5 of this sec- Classes, Standards, and Grades for tion. Poultry and Rabbits, AMS 70.200 and (c) Products that may be individually 70.300 et seq., respectively, or to the grademarked. The grademarks set forth containers in which such products are in Figures 2 through 4 of this section enclosed for the purpose of display and may be applied individually to ready- sale to household consumers, only to-cook poultry, rabbits, and specified when such products qualify for the par- poultry food products for which con- ticular grade indicated in accordance sumer grades are provided in the U.S. with the consumer grades.
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[63 FR 40628, July 30, 1998]
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§ 70.52 Prerequisites to packaging § 70.62 Reports of violations. ready-to-cook poultry or rabbits Each grader shall report, in the man- identified with consumer grademarks. ner prescribed by the Administrator, all violations of and noncompliance The official identification of any with the Act and the regulations in graded product as provided in §§ 70.50 this part of which he has knowledge. and 70.51 shall be done only under the supervision of a grader. The grader FEES AND CHARGES shall have supervision over the use and handling of all material bearing any of- § 70.70 Payment of fees and charges. ficial identification. (a) Fees and charges for any grading service shall be paid by the interested § 70.54 Retention authorities. party making the application for such A grader may use retention tags or service in accordance with the applica- other devices and methods as approved ble provisions of this section and by the Administrator for the identi- §§ 70.71 through 70.78 inclusive. If so re- fication and control of poultry or rab- quired by the grader, such fees and bit products which are not in compli- charges shall be paid in advance. ance with the regulations or are held (b) Fees and charges for any grading for further examination. Any such item service shall, unless otherwise required shall not be released until in compli- pursuant to paragraph (c) of this sec- ance with the regulations and reten- tion, be paid by check, draft, or money order payable to the Agricultural Mar- tion identification shall not be re- keting Service and remitted promptly moved by anyone other than a grader. to the Service. § 70.55 Check grading officially identi- (c) Fees and charges for any grading fied product. under a cooperative agreement with any State or person shall be paid in ac- Officially identified poultry or rabbit cordance with the terms of such coop- products may be subject to final check erative agreement. grading prior to their shipment. Such product found not to be in compliance § 70.71 On a fee basis. with the assigned official grade shall (a) Unless otherwise provided in this be placed under a retention tag until it part, the fees to be charged and col- is regraded to comply with the grade lected for any service performed, in ac- assigned or until the official identifica- cordance with this part, on a fee basis tion is removed. shall be based on the applicable rates specified in this section. REPORTS (b) Fees for grading services will be § 70.60 Report of grading work. based on the time required to perform such services for class, quality, quan- Reports of the work of grading car- tity (weight test), or condition, wheth- ried on within official plants shall be er ready-to-cook poultry, ready-to- forwarded to the Administrator by the cook rabbits, or specified poultry food grader in such manner as may be speci- products are involved. The hourly fied by the Administrator. charge shall be $51.32 and shall include the time actually required to perform § 70.61 Information to be furnished to the work, waiting time, travel time, graders. and any clerical costs involved in The applicant for grading service issuing a certificate. shall furnish to the grader rendering (c) Grading services rendered on Sat- such service such information as may urdays, Sundays, or legal holidays be required for the purposes of this shall be charged for at the rate of $59.12 part. per hour. Information on legal holidays is available from the Supervisor. [47 FR 46071, Oct. 15, 1982; 47 FR 54421, Dec. 3, 1982] [65 FR 57941, Sept. 27, 2000]
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§ 70.72 Fees for appeal grading, or ex- (1) A charge for the salary and other amination or review of a grader’s costs, as specified in this paragraph, decision. for each grader while assigned to a The costs of an appeal grading, or ex- plant, except that no charge will be amination or review of a grader’s deci- made when the assigned grader is tem- sion, will be borne by the appellant on porarily reassigned by AMS to perform a fee basis at rates set forth in § 70.71, grading service for other than the ap- plus any travel and additional ex- plicant. Base salary rates will be deter- penses. If the appeal grading, or exam- mined on a national average for all of- ination or review of a grader’s decision ficial plants operating in States under discloses that a material error was a Federal Trust Fund Agreement where made in the original determination, no Federal graders, State graders, or a fee or expenses will be charged. combination of Federal and State grad- [63 FR 52133, Sept. 30, 1998] ers are used, by averaging the salary rates paid to each Federal or State § 70.75 Travel expenses and other grader assigned to such plants. Charges charges. to plants are as follows: Charges are to be made to cover the (i) For all regular hours of work cost of travel and other expenses in- scheduled and approved as an estab- curred by the Service in connection lished tour of duty for a plant, the reg- with rendering grading service. Such ular rate charge will be made. The reg- charges shall include the cost of trans- ular rate charge will be determined by portation, per diem, and any other ex- adding an amount to the base salary penses. rate to cover the costs to AMS for such items as the Employer’s Tax imposed [42 FR 2971, Jan. 14, 1977. Redesignated at 42 FR 32514, June 27, 1977, as amended at 46 FR under the U.S. Internal Revenue Code 9, Jan. 2, 1981. Redesignated at 46 FR 63203, (26 U.S.C.) for Old Age and Survivor’s Dec. 31, 1981] Benefits under the Social Security Sys- tem, retirement benefits, group life in- § 70.76 Charges for continuous poultry surance, severance pay, sick leave, an- grading performed on a non- nual leave, additional salary and travel resident basis. costs for relief grading service, acci- Fees to be charged and collected for dent payments, certain moving costs, grading service on a nonresident grad- and related servicing costs. ing basis shall be those provided in this (ii) All hours worked by an assigned section. The fees to be charged for any grader or another grader in excess of appeal grading shall be as provided in the approved tour of duty, or worked § 70.72. on a nonscheduled workday, or actu- (a) Charges. The charges for the grad- ally worked on a holiday in excess of ing of poultry and edible products the tour of duty, will be considered as thereof shall be paid by the applicant overtime. The charge for such overtime for the service and shall include items will be 150 percent of the grader’s base listed in this section as are applicable. salary rate. Payment for the full cost of the grad- ing service rendered to the applicant (iii) For work performed on a holiday shall be made by the applicant to the which is within the established tour of Agricultural Marketing Service, U.S. duty approved for a plant, the added Department of Agriculture (hereinafter charge will be the same as the grader’s referred to as ‘‘AMS’’). Such full costs base rate. shall comprise such of the items listed (iv) For work performed between 6 in this section as are due and included p.m. and 6 a.m., night differential in the bill or bills covering the period charges (for regular, overtime, or holi- or periods during which the grading day hours worked during this period) service was rendered. Bills will be ren- will be at the applicable rates estab- dered by the 10th day following the end lished plus 10 percent of the base rate. of the billing period in which the serv- (v) For work performed on Sunday, ice was rendered and are payable upon Sunday differential charges (for reg- receipt. ular, overtime, or holiday hours
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worked on Sunday) will be at the appli- Finding Aids section of the printed volume cable rates established plus 25 percent and on GPO Access. of the base rate. (vi) For all hours of work performed § 70.77 Charges for continuous poultry in a plant without an approved tour of or rabbit grading performed on a duty, the charge will be one of the ap- resident basis. plicable hourly rates in § 70.71. Fees to be charged and collected for (2) An administrative service charge any grading service, other than for an equal to 25 percent of the grader’s total appeal grading, on a resident grading salary costs. A minimum charge of $260 basis, shall be those provided in this will be made each billing period. The section. The fees to be charged for any minimum charge also applies where an appeal grading shall be as provided in approved application is in effect and no § 70.72. product is handled. (a) Charges. The charges for the grad- (b) Other provisions. (1) The applicant shall designate in writing the employ- ing of poultry and rabbits and edible ees of the applicant who will be re- products thereof shall be paid by the quired and authorized to furnish each applicant for the service and shall in- grader with such information as may clude items listed in this section as are be necessary for the performance of the applicable. Payment for the full cost of grading service. the grading service rendered to the ap- (2) AMS will provide, as available, an plicant shall be made by the applicant adequate number of graders to perform to the Agricultural Marketing Service the grading service. The number of U.S. Department of Agriculture (here- graders required will be determined by inafter referred to as ‘‘AMS’’). Such AMS based on the expected demand for full costs shall comprise such of the service. items listed in this section as are due (3) The grading service shall be pro- and included in the bill or bills cov- vided at designated locations and shall ering the period or periods during be continued until the service is sus- which the grading service was ren- pended, withdrawn, or terminated by: dered. Bills will be rendered by the 10th (i) Mutual consent; day following the end of the billing pe- (ii) Thirty (30) days’ written notice riod in which the service was rendered by either the applicant or AMS speci- and are payable upon receipt. fying the date of suspension, with- drawal or termination; (1) An inauguration charge of $310 (iii) One (1) day’s written notice by will be made at the time an application AMS to the applicant if the applicant for service is signed, except when the fails to honor any invoice within thirty application is required because of a (30) days after date of invoice covering change in name or ownership. If service the cost of the grading service; or is not installed within 6 months from (iv) Action taken by AMS pursuant the date the application is filed, or if to the provisions of § 70.38 or § 70.40. service is inactive due to an approved (4) Graders will be required to confine request for removal of a grader(s) for a their activities to those duties nec- period of 6 months, the application will essary in the rendering of grading serv- be considered terminated, but a new ice and such closely related activities application may be filed at any time. as may be approved by AMS: Provided, In addition, there will be a charge of That in no instance may the graders $300 if the application is terminated at assume the duties of management. the request of the applicant for reasons (5) When similar nonresident grading other than for a change in location services are furnished to the same ap- within 12 months from the date of the plicant under part 55 or part 56 of this inauguration of service. chapter, the charges listed in this sec- (2) A charge for the salary and other tion shall not be repeated. costs, as specified in this paragraph, [41 FR 23681, June 11, 1976] for each grader while assigned to a EDITORIAL NOTE: For Federal Register cita- plant, except that no charge will be tions affecting § 70.76, see the List of CFR made when the assigned grader is tem- Sections Affected, which appears in the porarily reassigned by AMS to perform
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grading service for other than the ap- (3) A charge at the hourly rates spec- plicant. Base salary rates will be deter- ified in § 70.71, plus actual travel ex- mined on a national average for all of- penses incurred by AMS for inter- ficial plants operating in States under mediate surveys to firms without grad- a Federal Trust Fund Agreement where ing service in effect. Federal graders, State graders, or a (4) For poultry grading: An adminis- combination of Federal and State grad- trative service charge based upon the ers are used, by averaging the salary aggregate weight of the total volume of rates paid to each Federal or State all live and ready-to-cook poultry han- grader assigned to such plants. Charges dled in the plant per billing period to plants are as follows: computed in accordance with the fol- (i) For all regular hours of work lowing: Total pounds per billing period scheduled and approved as an estab- multiplied by $0.00035, except that the lished tour of duty for a plant, the reg- minimum charge per billing period ular rate charge will be made. The reg- shall be $225 and the maximum charge ular rate charge will be determined by shall be $2,625. The minimum charge adding an amount to the base salary also applies where an approved applica- rate to cover the costs to AMS for such tion is in effect and no product is han- items as the Employer’s Tax imposed dled. under the U.S. Internal Revenue Code (5) For rabbit grading: An adminis- (26 U.S.C.) for Old Age and Survivor’s trative service charge equal to 25 per- Benefits under the Social Security Sys- cent of the grader’s total salary costs. tem, retirement benefits, group life in- A minimum charge of $260 will be made surance, severance pay, sick leave, an- each billing period. The minimum nual leave, additional salary and travel charge also applies where an approved costs for relief grading service, acci- application is in effect and no product dent payments, certain moving costs, is handled. and related servicing costs. (b) Other provisions. (1) The applicant (ii) All hours worked by an assigned shall designate in writing the employ- grader or another grader in excess of ees of the applicant who will be re- the approved tour of duty, or worked quired and authorized to furnish each on a nonscheduled workday, or actu- grader with such information as may ally worked on a holiday in excess of be necessary for the performance of the the tour of duty will be considered as overtime. The charge for such overtime grading service. will be 150 percent of the grader’s base (2) AMS will provide, as available, an salary rate. adequate number of graders to perform (iii) For work performed on a holiday the grading service. The number of which is within the established tour of graders required will be determined by duty approved for a plant, the added AMS based on the expected demand for charge will be the same as the grader’s service. base rate. (3) The grading service shall be pro- (iv) For work performed between 6 vided at the designated plant and shall p.m. and 6 a.m., night differential be continued until the service is sus- charges (for regular, overtime, or holi- pended, withdrawn, or terminated by: day hours worked during this period) (i) Mutual consent; will be at the applicable rates estab- (ii) Thirty (30) days’ written notice lished plus 10 percent of the base rate. by either the applicant or AMS speci- (v) For work performed on Sunday, fying the date of suspension, with- Sunday differential charges (for reg- drawal, or termination; ular, overtime, or holiday hours (iii) One (1) day’s written notice by worked on Sunday) will be at the appli- AMS to the applicant if the applicant cable rates established plus 25 percent fails to honor any invoice within thirty of the base rate. (30) days after date of invoice covering (vi) For all hours of work performed the cost of the grading service; or in a plant without an approved tour of (iv) Action taken by AMS pursuant duty, the charge will be one of the ap- to the provisions of § 70.38 through plicable hourly rates in § 70.71. § 70.40.
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(4) Graders will be required to confine [41 FR 23681, June 11, 1976. Redesignated at 42 their activities to those duties nec- FR 32514, June 27, 1977, and further redesig- essary in the rendering of grading serv- nated at 46 FR 63203, Dec. 31, 1981, as amend- ice and such closely related activities ed at 51 FR 17280, May 9, 1986; 63 FR 40630, July 30, 1998] as may be approved by AMS: Provided, That in no instance may the graders § 70.81 Ready-to-cook poultry and rab- assume the duties of management. bits and specified poultry food [41 FR 23681, June 11, 1976] products. (a) Ready-to-cook poultry or rabbit EDITORIAL NOTE: For Federal Register cita- tions affecting § 70.77, see the List of CFR carcasses or parts or specified poultry Sections Affected, which appears in the food products may be graded only if Finding Aids section of the printed volume they have been inspected and certified and on GPO Access. by the poultry inspection service of the U.S. Department of Agriculture, or in- § 70.78 Fees or charges for grading spected and passed by any other inspec- service performed under coopera- tion system which is acceptable to the tive agreement. Department. Fees or charges to be made to an ap- (b) Only when ready-to-cook poultry plicant for any grading service which carcasses, parts, poultry food products, differ from those listed in §§ 70.70 including those used in preparing raw through 70.77, shall be provided for by a poultry food products, have been grad- cooperative agreement. ed on an individual basis by a grader or by an authorized person pursuant to GRADING § 70.20(c) and thereafter checkgraded by a grader, and when poultry food prod- § 70.80 General. ucts have been prepared under the su- Whenever grading service is provided pervision of a grader, may the indi- for examination of quality, condition, vidual container, carcass, part, or poul- or for test weighing on a representative try food product be identified with the sample basis, such sample shall be appropriate official letter grademark. drawn and consist of not less than the Checkgrading will be accomplished in minimum number of containers indi- accordance with a statistical sampling cated in the following table. The num- plan prescribed by the Administrator. ber of representative samples for large Grading with respect to quality factors bulk containers (combo bins, tanks, for freezing defects and appearance of etc.) may be reduced by one-half. For the finished products may be done on a quality or condition, all of the poultry sample basis in accordance with a plan and rabbits in each representative sam- prescribed by the Administrator. ple shall be examined except for indi- (c) Only when ready-to-cook rabbit vidual ready-to-cook carcasses weigh- carcasses or parts have been graded on ing under 6 pounds in large bulk con- an individual basis by a grader or by an tainers. For individual carcasses authorized person pursuant to § 70.20(c) weighing under 6 pounds in large bulk and thereafter checkgraded by a grad- containers, 100 carcasses shall be exam- er, may the container or the individual ined for quality or condition. Proce- carcass or part be identified with the dures for test weighing shall be in ac- appropriate official letter grademark. cordance with those prescribed by the Checkgrading will be accomplished in Administrator. accordance with a statistical sampling plan prescribed by the Administrator. Containers in lot Containers in sample Grading with respect to quality factors 1Ð4 ...... All. for freezing defects and appearance of 5Ð50 ...... 4. the finished products may be done on a 51Ð100 ...... 5. sample basis in accordance with a plan 101Ð200 ...... 6. prescribed by the Administrator. 201Ð400 ...... 7. 401Ð600 ...... 8. [41 FR 23681, June 11, 1976. Redesignated at 42 For each additional 100 con- Include one additional con- FR 32514, June 27, 1977, and further redesig- tainers, or fraction thereof, tainer. nated at 46 FR 63203, Dec. 31, 1981, as amend- in excess of 600 containers. ed at 51 FR 17281, May 9, 1986]
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GRADING CERTIFICATES APPEAL OF A GRADING OR DECISION
§ 70.90 Forms. § 70.100 Who may request an appeal grading or review of a grader’s de- Grading certificates (including ap- cision. peal grading certificates and regrading certificates) shall be issued on forms An appeal grading may be requested approved by the Administrator. by any interested party who is dissatis- fied with the determination by a grader § 70.91 Issuance and disposition. of the class, quality, quantity, or con- (a) Resident grading basis. Certificates dition of any product as evidenced by will be issued only upon a request the USDA grademark and accom- therefor by the applicant or the Serv- panying label, or as stated on a grading ice. When requested, a grader shall certificate, and a review may be re- issue a certificate covering product quested by the operator of an official graded by him. In addition, a grader plant with respect to a grader’s deci- may issue a grading certificate cov- sion on any other matter relating to ering product graded in whole or in grading in an official plant. part by another grader when the grader has knowledge that the product is eli- § 70.101 Where to file an appeal. gible for certification based on per- (a) Appeal from resident grader’s grad- sonal examination of the product or of- ing or decision in an official plant. Any ficial grading records. interested party who is not satisfied (b) Other than resident grading. Each with the determination of the class, grader shall, in person or by his au- quality, quantity, or condition of prod- thorized agent, issue a grading certifi- uct which was graded by a grader in an cate covering each product graded by official plant and has not left such him. A grader’s name may be signed on plant, and the operator of any official a grading certificate by a person other plant who is not satisfied with a deci- than the grader if such person has been sion made by a grader or any other designated as the authorized agent of matter relating to grading in such such grader by the national supervisor: plant, may request an appeal grading Provided, That the certificate is pre- or review of the decision by filing such pared from an official memorandum of request with the grader’s immediate grading signed by the grader. supervisor. (c) The original and a copy of each (b) All other appeal requests. Any in- grading certificate, issued pursuant to terested party who is not satisfied with §§ 70.90 through 70.92, and not to exceed the determination of the class, quality, two additional copies thereof if re- quantity, or condition of product which quested by the applicant prior to has left the official plant where it was issuance shall, immediately upon graded, or which was graded other than issuance, be delivered or mailed to the in an official plant, may request an ap- applicant or person designated by him. peal grading by filing such request Other copies shall be filed and retained with the regional director in the area in accordance with the disposition where the product is located or with schedule for grading program records. the Chief of the Grading Branch.
[41 FR 23681, June 11, 1976. Redesignated at 42 § 70.102 How to file an appeal. FR 30514, June 27, 1977, and further redesig- nated at 46 FR 63203, Dec. 31, 1981, as amend- Any request for an appeal grading or ed at 47 FR 46071, Oct. 15, 1982; 47 FR 54421, review of a grader’s decision may be Dec. 3, 1982; 51 FR 17281, May 9, 1986] made orally or in writing. If made oral- ly, written confirmation may be re- § 70.92 Advance information. quired. The applicant shall clearly Upon the request of an applicant, all state the reasons for requesting the ap- or part of the contents of any grading peal service, and a description of the certificate issued to such applicant product or the decision which is ques- may be telephoned or telegraphed to tioned. If such appeal request is based him, or to any person designated by on the results stated on an official cer- him, at his expense. tificate, the original and all available
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copies of the certificate shall be re- or rabbits in the sample prior to appeal turned to the appeal grader assigned to grading for quality or to determine the make the appeal grading. class. (e) When the appeal is based on grad- § 70.103 When an application for an ing or class determination factors, appeal grading may be refused. each frozen carcass shall be defrosted When it appears to the official with prior to conducting the appeal grading. whom an appeal request is filed that Whether defrosting poultry or rabbit the reasons given in the request for an carcasses for other types of appeals appeal grading are frivolous or not sub- will be required by the appeal grader, stantial, or that the quality or condi- will depend upon the reason for the ap- tion of the product has undergone a peal. material change since the original grading, or that the original lot has § 70.106 Appeal grading certificates. changed in some manner, or the Act or the regulations in this part have not Immediately after an appeal grading been complied with, the applicant’s re- is completed, an appeal certificate quest for the appeal grading may be re- shall be issued to show that the origi- fused. In such case, the applicant shall nal grading was sustained or was not be promptly notified of the reason(s) sustained. Such certificate shall super- for such refusal. sede any previously issued certificate for the product involved and shall § 70.104 Who shall perform the appeal. clearly identify the number and date of (a) An appeal grading or review of a the superseded certificate. The decision requested under § 70.101(a) issuance of the appeal certificate may shall be made by the grader’s imme- be withheld until any previously issued diate supervisor or by a licensed grader certificate and all copies have been re- assigned by the immediate supervisor turned when such action is deemed nec- other than the grader whose grading or essary to protect the interest of the decision is being appealed. Government. When the appeal grader (b) Appeal gradings requested under assigns a different grade to the lot, the § 70.101(b) shall be performed by a grad- existing grademark shall be changed or er other than the grader who originally obliterated as necessary. When the ap- graded the product. peal grader assigns a different class or (c) Whenever practical, an appeal quantity designation to the lot, the la- grading shall be conducted jointly by beling shall be corrected. two graders. The assignment of the grader(s) who will make the appeal SANITARY REQUIREMENTS, FACILITIES, grading requested under § 70.101(b) shall AND OPERATING PROCEDURES be made by the regional director or the Chief of the Grading Branch. § 70.110 Requirements for sanitation, facilities, and operating procedures § 70.105 Procedures for appeal in official plants. gradings. (a) The requirements for sanitation, (a) When all of the originally graded facilities, and operating procedures in and identified samples are available, official plants shall be the applicable the appeal sample shall consist of such samples plus an equal number of sam- provisions stated in 9 CFR part 381 for ples. poultry, and for rabbits the require- (b) When the original samples are not ments shall be the applicable provi- available, the appeal sample size for sions stated in 9 CFR part 354. the lot shall consist of double the sam- (b) With respect to grading services, ples required in § 70.80. there shall be a minimum of 100-foot (c) Poultry or rabbits in an unfrozen candles of light intensity at grading state must be adequately protected and stations; and acceptable means, when kept in good condition until the appeal necessary, of maintaining control and grading is performed. identity of products segregated for (d) Overwraps on frozen poultry or quality, class, condition, weight, lot, or rabbits shall be removed from all birds any other factor which may be used to
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distinguish one type of product from 75.34 Surrender of license. another. SAMPLING PROVISIONS AND REQUIREMENTS [41 FR 23681, June 11, 1976. Redesignated at 42 75.35 Obtaining samples for lot inspections. FR 32514, June 27, 1977, and further redesig- 75.36 Representative sample. nated at 46 FR 63203, Dec. 31, 1981, as amend- 75.37 Submitted samples. ed at 51 FR 17281, May 9, 1986; 63 FR 40630, 75.38 Lot inspections. July 30, 1998] 75.39 Use of file samples. 75.40 Protecting samples. Subparts B–C [Reserved] FEES AND CHARGES PART 75—REGULATIONS FOR IN- 75.41 General. SPECTION AND CERTIFICATION 75.42 Sampling and sealing. 75.43 Laboratory testing. OF QUALITY OF AGRICULTURAL 75.44 When application rejected or with- AND VEGETABLE SEEDS drawn. 75.45 Charge for appeals. DEFINITIONS 75.46 When appeal refused or withdrawn. 75.47 For certificates. Sec. 75.1 Meaning of words. MISCELLANEOUS 75.2 Terms defined. 75.48 Identification number. ADMINISTRATION 75.49 OMB control numbers.
75.3 Authority. AUTHORITY: 7 U.S.C. 1622 and 1624. 75.4 Federal and State cooperation. 75.5 Regulations not applicable for certain SOURCE: 49 FR 18724, May 2, 1984, unless purposes. otherwise noted. 75.6 Nondiscrimination. DEFINITIONS INSPECTION 75.7 Inspection in accordance with methods § 75.1 Meaning of words. prescribed or approved. Words used in the regulations in this 75.8 Basis of service. part in the singular form shall be 75.9 Who may obtain service. deemed to import the plural and vice 75.10 How to make application. versa, as the case may demand. 75.11 Content of application. 75.12 When application deemed filed. 75.13 When application may be rejected. § 75.2 Terms defined. 75.14 When application may be withdrawn. For the purpose of these regulations 75.15 Authority of agent. unless the context otherwise requires, 75.16 Accessibility of seeds. the following terms shall be construed, 75.17 Testing. 75.18 Sampling. respectively, as follows: 75.19 Seed lot inspection. (a) Act means the Agricultural Mar- 75.20 Submitted sample inspection. keting Act of 1946, as amended (7 U.S.C. 75.21 Grain sample inspection. 1621 et seq.). 75.22 Form of inspection certificate. (b) Regulations means the regulations 75.23 Issuance of inspection certificate. in this part. 75.24 Disposition of inspection certificate. (c) Department means the United 75.25 Issuance of corrected certificate. States Department of Agriculture APPEAL INSPECTION (USDA). 75.26 When appeal inspection may be re- (d) Secretary means the Secretary of quested. the United States Department of Agri- 75.27 How to file an appeal. culture, or any officer or employee of 75.28 When a request for an appeal inspec- the Department to whom authority has tion may be withdrawn. been delegated to act in the Sec- 75.29 When an appeal may be refused. retary’s stead. 75.30 Who shall perform appeal inspection. 75.31 Appeal inspection certificate. (e) Administrator means the Adminis- trator of the Agricultural Marketing LICENSING OF INSPECTORS Service (AMS) of the Department, or 75.32 Who may become licensed inspector. any other officer or employee of AMS 75.33 Suspension or revocation of license of to whom authority has been delegated inspector. to act in the Administrator’s stead.
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(f) Division means the Warehouse and relate to the subject matter of the reg- Seed Division (WSD), AMS. ulations, under the supervision of the (g) Director means the Director of the Secretary and the Administrator. Division or any other officer or em- ployee of the Division to whom author- § 75.4 Federal and State cooperation. ity has been delegated to act in the Di- Pursuant to the Act, the Adminis- rector’s stead. trator is authorized to cooperate with (h) Person means any individual, the appropriate State agencies in car- partnership, association, business rying out provisions of the Act and trust, corporation, entity, or any other these regulations through Memoranda organized group of persons, whether in- of Understanding. The Memorandum of corporated or not. Understanding shall specify the duties (i) Seed means any agricultural or to be performed by the parties con- vegetable seed. cerned with each party directing its (j) Interested Party means any person own activities and utilizing its own re- financially interested in a transaction sources. involving seed. (k) Applicant means an interested § 75.5 Regulations not applicable for party who requests any inspection certain purposes. service with respect to seed. The regulations do not apply to the (l) Authorized agent means an agent inspection of grain in the United to whom authority to represent a per- States under the U.S. Grain Standards son or government agency has been Act, as amended (7 U.S.C. 71 et seq.), ex- given by that person or government cept to the extent that official grain agency through delegation, contract or samples received from the Federal cooperative agreement, or other Grain Inspection Service (FGIS) shall means. be examined for the presence of speci- (m) Memorandum of Understanding fied weed and crop seeds upon the re- means a written plan between AMS and quest of FGIS. a State for carrying out their separate activities in a project of mutual inter- § 75.6 Nondiscrimination. est to the parties involved. The conduct of all services under (n) Inspector means a licensed em- these regulations shall be accom- ployee of a State authorized pursuant plished without discrimination as to to a Memorandum of Understanding or race, color, religion, sex, or national an employee of the Department author- origin. ized by the Director, to draw samples of seeds, seal containers, inspect INSPECTION records, test seeds for quality, issue certificates and reports, and bill for § 75.7 Inspection in accordance with methods prescribed or approved. services. (o) Inspection means sampling seeds, Inspection of seed shall be rendered sealing containers, testing seeds for pursuant to these regulations and quality and reviewing records. under such conditions and in accord- (p) Appeal inspector means an inspec- ance with the methods of either the As- tor or other person designated or au- sociation of Official Seed Analysts thorized by the Division to perform ap- (AOSA) or the International Seed Test- peal inspections under the Act and reg- ing Association (ISTA). ulations in this subpart. (q) Certificate means a certificate § 75.8 Basis of service. issued under the Act and the regula- The regulations provide for inspec- tions in this subpart. tion services pursuant to the Act. Seeds shall be inspected in accordance ADMINISTRATION with the methods of either the Associa- tion of Official Seed Analysts (AOSA) § 75.3 Authority. or the International Seed Testing Asso- The Director is charged with the ad- ciation (ISTA); provided, that limita- ministration of the provisions of the tions in these rules respecting max- regulations and the Act insofar as they imum lot size will not be observed and,
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provided further, that certification as § 75.15 Authority of agent. to origin may be based on examination Proof of authority of any person of records and certification of other making an application as an agent may seed certifying agencies. be required in the discretion of the offi- cial receiving the application. § 75.9 Who may obtain service. An application for inspection service § 75.16 Accessibility of seeds. may be made by any interested party Each lot of seed for which a lot in- or his authorized agent. spection is requested shall be placed by the applicant so as to permit the entire § 75.10 How to make application. lot to be sampled and a representative An application for service shall be sample to be obtained as required. confirmed in writing and addressed to the Federal Seed Laboratory, WSD, § 75.17 Testing. AMS, USDA, Beltsville, Maryland Upon request by the applicant, tests 20705. may be made for kind, variety, germi- nation, purity, weed seeds, disease § 75.11 Content of application. pathogens, treatment, moisture, and An application for service shall in- other special tests, or any combination clude the following information; (a) thereof for which prescribed methods of The date of application; (b) the kind testing are established. The tests shall and quantity of seed, and test(s) to be be in accordance with the methods of performed; (c) the methods and instruc- either the Association of Official Seed tions for the inspection of the seed (ei- Analysts (AOSA) or the International ther Association of Official Seed Ana- Seed Testing Association (ISTA) as re- lysts (AOSA) or International Seed quested by the applicant. Testing Association (ISTA) rules); (d) the name and address of the applicant § 75.18 Sampling. and, if made by an authorized agent; Sampling, when requested by the ap- and (e) such further information relat- plicant, shall be in accordance with the ing to the inspection as may be re- methods of either the Association of quired. Official Seed Analysts (AOSA) or the International Seed Testing Association § 75.12 When application deemed filed. (ISTA), depending upon the test meth- An application shall be deemed filed od requested by the applicant. when received by the Division or the Federal Seed Laboratory. § 75.19 Seed lot inspection. A lot inspection shall be made by ob- § 75.13 When application may be re- taining a representative sample from a jected. specified quantity of seed identified Any application for service may be with a distinguishing mark or number rejected by the Director (a) for non- to appear on all containers in the lot, compliance with the Act or the regula- and performing such test(s) as may be tions relating to applications for serv- requested by the applicant. The identi- ice in this subpart, or (b) when it is not fication mark or number must be ap- practicable to provide the service. proved by the inspector and will appear Each such applicant shall be promptly on the certificate to be issued. notified in writing. § 75.20 Submitted sample inspection. § 75.14 When application may be with- A sample inspection shall be made by drawn. testing a sample of seed submitted by An application may be withdrawn at an applicant for inspection. any time before the requested service is rendered. The applicant will remain § 75.21 Grain sample inspection. responsible for payment of expenses in- A sample inspection shall be per- curred in connection therewith as pro- formed by examining official grain vided in § 75.44. samples received from FGIS to identify
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specified weed and crop seeds upon the the Federal Seed Laboratory. In case of request of FGIS. a lost or destroyed certificate, a dupli- cate thereof labeled as such may be § 75.22 Form of inspection certificate. issued under the same number, date, Inspection certificates shall be ap- and name. proved by the Director as to their form. No correction, erasure, or other § 75.25 Issuance of corrected certifi- change shall be made in the informa- cate. tion on a certificate. (a) If any error is made in an inspec- tion, a corrected inspection certificate § 75.23 Issuance of inspection certifi- cate. may be issued. (b) The original and copies of the cor- After an inspection has been com- rected certificate shall be issued as pleted, an inspection certificate shall promptly as possible to the same inter- be issued showing the results of the in- ested persons who received the incor- spection in accordance with paragraph rect certificate. (a) or (b) of this section. (a) Lot inspection certificate. A lot in- (c) The corrected certificate shall su- spection certificate shall be issued to persede the incorrect inspection cer- include the name of the inspector sam- tificate previously issued. The cor- pling and sealing the seed lot, the anal- rected certificate shall clearly identify, ysis results from testing the sample, by certificate number and date, the in- the identifying mark or number which correct certificate which it supersedes. has been approved by the inspector to (d) The original and all copies of the appear on each container in the seed superseded incorrect certificate shall lot, and any other factual information be obtained by the Director, if possible. pertinent to the inspection. If it is not possible to obtain the origi- (b) Sample inspection certificate. A nal and all copies of the superseded cer- sample inspection certificate shall be tificate, to the extent possible, all par- issued to show the results of the in- ties involved will be notified to prevent spection of a sample of seed or grain misuse of the superseded certificate submitted by an interested party. Each and the corrected certificate so marked sample inspection certificate shall as to the outstanding certificate. state the results of the inspection that applies only to the sample described in APPEAL INSPECTION the certificate. (c) General authorization to issue cer- § 75.26 When appeal inspection may be tificates. Certificates for inspections requested. may be issued by any inspector author- A request for an appeal inspection ized by the Director to perform the in- may be made by any interested party spection covered by the certificate. regarding the results of an inspection (d) Name requirements. The name and as stated on an inspection certificate. signature of the person who issued the Such request shall be made within thir- inspection certificate shall be shown on ty (30) days following the day on which the certificate. The original certificate an inspection certificate was issued. must be signed, and the signature or a stamped facsimile shall be shown on § 75.27 How to file an appeal. each copy. Any request for an appeal inspection § 75.24 Disposition of inspection cer- may be made orally or in writing to tificate. the Federal Seed Laboratory. If made Upon issuance, the original and one orally, written confirmation is re- copy of each inspection certificate quired. The applicant shall clearly shall be delivered or mailed to the ap- state the reasons for requesting the ap- plicant or otherwise delivered or peal service. The original and all avail- mailed in accordance with the appli- able copies of the certificate shall be cant’s instructions. One copy of each returned to the appeal inspector as- inspection certificate shall be filed in signed to make the appeal inspection.
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§ 75.28 When a request for an appeal cate shall forward notice of such inspection may be withdrawn issuance to such persons as considered A request for an appeal inspection necessary to prevent misuse of the su- may be withdrawn by the applicant at perseded certificate if the original and any time before the appeal inspection all copies of such superseded certificate is performed: Provided, that, the appel- have not previously been delivered to lant shall pay any expenses incurred in the inspector issuing the appeal inspec- connection with the appeal as provided tion certificate. The appeal inspection in § 75.46. certificate shall be marked as to the existence of the outstanding certifi- § 75.29 When an appeal may be re- cate. The provisions in the regulations fused. concerning forms of certificates and A request for an appeal inspection disposition of certificates shall apply may be refused if: to appeal inspection certificates, ex- (a) The reasons for an appeal inspec- cept that copies of such appeal inspec- tion are frivolous or not substantial; tion certificates shall be furnished to (b) The quality or condition of the seed has been altered since the inspec- all interested parties who received cop- tion covering the seed on which the ap- ies of the superseded certificate. peal inspection is requested; LICENSING OF NSPECTORS (c) The lot in question in a lot inspec- I tion is not or cannot be made acces- § 75.32 Who may become licensed in- sible for sampling; spector. (d) The lot relative to which appeal inspection is requested cannot be posi- Any person nominated by a cooper- tively identified by the inspection as ating State and who is found to have the lot from which drawn samples were the necessary qualifications may be li- previously inspected in a lot inspec- censed by the Director as an inspector tion; or to perform such duties of inspection as (e) The application is not in compli- specified by the Memorandum of Un- ance with the regulations; and derstanding. Such a license shall bear (f) Such applicant shall be notified the signature of an authorized em- promptly of the reason for such refusal. ployee of the Department. A licensed inspector shall perform duties pursuant § 75.30 Who shall perform appeal in- to the regulations in accordance with spection. instructions issued or approved by the An appeal inspection shall be per- Director. formed by an inspector (other than the one from whose inspection the appeal § 75.33 Suspension or revocation of li- is requested) authorized for this pur- cense of inspector. pose by the Director. Pending final action by the Adminis- § 75.31 Appeal inspection certificate. trator, the Director may suspend, whenever it is deemed that such action After an appeal inspection has been is necessary to assure that any service completed, an appeal inspection certifi- cate shall be issued showing the results provided is performed properly, the li- of such appeal inspection; and such cer- cense of any inspector, issued pursuant tificate shall supersede the inspection to the regulations by giving notice of certificate previously issued for the such suspension to the respective li- seed involved. Each appeal inspection censee, accompanied by a statement of certificate shall clearly identify the the reasons therefore. Within 7 days number and date of the inspection cer- after receipt of notice and statement of tificate which it supersedes. The super- reasons by a licensee, an appeal may be seded certificate shall become null and filed in writing with the Administrator void upon the issuance of the appeal in- supported by any argument or evidence spection certificate and shall no longer as to why the license should not be sus- represent the quality or condition of pended. After expiration of the 7-day the seed described therein. The inspec- period and consideration of such argu- tor issuing an appeal inspection certifi- ment and evidence, the Administrator
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shall take such action as deemed ap- representative for appeal inspections: propriate with respect to a suspension Provided, that (1) the samples have re- or revocation. mained in the custody of the inspection personnel who certificated the inspec- § 75.34 Surrender of license. tion; and (2) the inspection personnel Upon termination of service as an in- who performed the inspection and the spector or suspension or revocation of inspection personnel who are to per- such license, such licensee shall sur- form the appeal inspection determine render the license immediately to the that the sample was representative of Federal Seed Laboratory. the seed at the time of the inspection and that the quality or condition of the SAMPLING PROVISIONS AND seed in the sample and in the lot has REQUIREMENTS not changed since the time of the in- § 75.35 Obtaining samples for lot in- spection. spections. (b) Upon request of the applicant, and Samples of seed for lot inspections if practicable, a new sample may be ob- may be obtained by licensed inspectors tained and examined as a part of an ap- or authorized employees of the Depart- peal inspection. ment. § 75.40 Protecting samples. § 75.36 Representative sample. Inspection personnel shall protect No lot inspection sample shall be each sample from manipulation, sub- deemed representative of a lot of seed stitution, and improper or careless unless the sample (a) has been obtained handling which would deprive the sam- by a licensed inspector or an author- ple of its representative character from ized employee of the Department; (b) is the time of collection until the inspec- of the size prescribed in the instruc- tion is completed and the file sample tions; and (c) has been obtained, han- has been discarded. dled, and submitted in accordance with the Association of Official Seed Ana- FEES AND CHARGES lysts (AOSA) or the International Seed Testing Association (ISTA) procedures. § 75.41 General. Fees and charges for inspection serv- § 75.37 Submitted samples. ices performed by Federal employees Submitted samples may be obtained shall cover the cost of performing the by or for any interested person. (In- service. Fees shall be for actual time structions for sampling seed may be required to render the service, cal- obtained upon request to the Director culated to the nearest 15-minute period or the Federal Seed Laboratory.) except that a minimum of 1 hour shall apply for testing and a 2-hour min- § 75.38 Lot inspections. imum shall apply for sampling and Each lot inspection shall be made on sealing. Fees and charges shall be at the basis of a representative sample ob- the rate of $44.40 per hour. (Cost esti- tained from that lot of seed by a li- mates may be obtained upon request to censed inspector or an authorized em- the Director or the Federal Seed Lab- ployee of the Department. Each lot of oratory.) seed which is offered for lot inspection shall be sealed at the time of sampling [49 FR 18724, May 2, 1984, as amended at 56 in accordance with methods and proce- FR 51320, Oct. 11, 1991; 58 FR 64101, Dec. 6, dures of the Association of Official 1993; 60 FR 21035, May 1, 1995; 65 FR 15832, Seed Analysts (AOSA) or the Inter- Mar. 24, 2000] national Seed Testing Association (ISTA). § 75.42 Sampling and sealing. (a) Fees for inspection services pro- § 75.39 Use of file samples. vided by licensed inspectors may be (a) File samples which are retained charged by States participating in the by inspection personnel in accordance program at rates established by the in- with the regulations may be deemed dividual States.
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(b) When onsite inspection services vided, That when a material error in are performed by Federal employees at the certificate or sample from which the request of the applicant: the appeal is taken is found by the ap- (1) Fees for onsite inspections for peal inspector the charge and fee shall sampling and sealing shall include the be waived. time for actual sampling and sealing, standby at the service site, travel time § 75.46 When appeal refused or with- and actual travel costs to and from the drawn. site, and a per diem charge if the em- When an appeal is refused in accord- ployee performing the service is paid ance with § 75.29 or withdrawn in ac- per diem in accordance with existing cordance with § 75.28, the applicant will travel regulations as appear in Agricul- be required to pay for the time used by tural Travel Regulations, including the the appeal inspector and other ex- Federal Travel Regulations, DM 2300–1. penses incurred in connection with (2) Hourly rates shall begin when the such appeal prior to its denial, dis- inspector begins travel to the service missal, or withdrawal. site and end when the inspector arrives back at his official station or resi- § 75.47 For certificates. dence, computed to the nearest quarter A charge of $11.10 per certificate will hour, less meal time, if any. be made for copies of certificates other (3) A 2-hour minimum shall be than those required to be distributed in charged for each onsite inspection. § 75.23 and for the issuance of a dupli- § 75.43 Laboratory testing. cate certificate in accordance with § 75.24 and an appeal certificate in Fees for testing each sample shall in- § 75.31. clude the time required for actual test- ing, preparation of test records, issuing [49 FR 18724, May 2, 1984, as amended at 56 the certificate, and filing of samples FR 51320, Oct. 11, 1991; 58 FR 64101, Dec. 6, and documents, with: 1993; 60 FR 21035, May 1, 1995; 65 FR 15832, (a) Charges billed at the hourly rate Mar. 24, 2000] in increments of 15 minutes. MISCELLANEOUS (b) A minimum fee of 1 hour per sam- ple for testing shall be charged. § 75.48 Identification number. § 75.44 When application rejected or The Director may require the use of withdrawn. official identification numbers in con- nection with seed certificated or sam- When an application for inspection is pled under the Act. When identification rejected in accordance with § 75.13 or numbers are required, they shall be withdrawn in accordance with § 75.14, specified by the Director and shall be the applicant will be required to pay attached to, or stamped, printed, or applicable fees for the time used by an stenciled on the lot of seed certificated inspector and other expenses incurred or sampled in a manner specified by in connection with such application the Director. prior to its rejection or withdrawal. § 75.49 OMB control numbers. § 75.45 Charge for appeals. A charge of 1 hour shall be made for The control number assigned to the each appeal filed under § 75.26, and the information collection requirements by fee for an appeal inspection shall equal the Office of Management and Budget the fee for the original inspection from pursuant to the Paperwork Reduction which the appeal is taken, plus any Act of 1980 is as follows: OMB Control charges for travel or other expenses in- No. 0581–0140. curred in performing the appeal: Pro- [56 FR 51320, Oct. 11, 1991]
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PART 80—FRESH IRISH POTATOES Service (AMS), United States Depart- ment of Agriculture (USDA), and will Subpart A—Fresh Irish Potato—Diversion be implemented by the Farm Service Program Agency (FSA). AMS, FSA, or their au- thorized representatives do not have Sec. authority to modify or waive any of 80.1 Applicability. the provisions of this subpart. 80.2 Administration. 80.3 Definitions. 80.4 Length of program. § 80.3 Definitions. 80.5 Rate of payment. Application means Form FSA–117. 80.6 Eligibility for payment. Charitable institutions means those or- 80.7 Application and approval for participa- tion. ganizations which offer food, housing, 80.8 Inspection and certificate of diversion. and other necessities to low income, 80.9 Claim for payment. homeless, or other persons in need of 80.10 Compliance with program provisions. assistance in obtaining basic suste- 80.11 Inspection of premises. nance. 80.12 Records and accounts. Diversion means the delivery of pota- 80.13 Offset and assignment. 80.14 Appeals. toes to an eligible outlet. Eligible outlet means charitable insti- Subpart B [Reserved] tutions or livestock feeding operations. Fresh Irish potatoes means the 1996 AUTHORITY: 7 U.S.C. 612c. crop of all types and varieties of pota- SOURCE: 58 FR 29098, May 19, 1993, unless toes (except sweet potatoes) fit for otherwise noted. human consumption and produced and stored in the United States. Subpart A—Fresh Irish Potato—Diversion Invoice and certificate of inspection and Program diversion means Form FSA–118. Producer means an individual, part- SOURCE: 62 FR 29650, June 2, 1997, unless nership, association, or corporation lo- otherwise noted. cated in the United States who grows § 80.1 Applicability. potatoes for market and is in posses- sion of such potatoes as of the date of In order to encourage the domestic May 29, 1997, and whose Form FSA–117 consumption of the 1996 crop of fresh has been approved by USDA. Irish potatoes by diverting them from normal channels of trade and com- § 80.4 Length of program. merce, the Secretary of Agriculture, pursuant to the authority conferred by This program will be effective May section 32 of the Act of August 24, 1935, 29, 1997, and will continue until August as amended (7 U.S.C. 612c) (Section 32), 27, 1997. Producers diverting potatoes will make payment to producers who to charitable institutions must file an divert fresh Irish potatoes that they application at the FSA office respon- produced by donating them to chari- sible for the county in which the farm table institutions for human consump- is located for FSA purposes within the tion or by using such fresh Irish pota- first ten Federal Government business toes as livestock feed in accordance days following the effective date of this with the terms and conditions set forth program. Producers diverting potatoes herein. to livestock feed must file an applica- tion at such office no later than Au- § 80.2 Administration. gust 27, 1997. Application for charitable The program will be administered diversions, as well as for livestock feed, under the general direction and super- will be accepted until August 27, 1997. vision of the Director, Fruit and Vege- [62 FR 29650, June 2, 1997, as amended at 62 table Division, Agricultural Marketing FR 40730, July 30, 1997]
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§ 80.5 Rate of payment. nels of trade and commerce as deter- mined by FSA or its representative; (a) The rate of payment for potatoes for charitable institutions will be $1.50 (2) Executes and files Form FSA–117 per hundredweight for fresh Irish pota- with the FSA county office responsible toes if packed in bags or cartons, and for the county where the producer’s will be $0.75 if shipped in bulk. All eli- farm is located for FSA program pur- gible fresh Irish potatoes intended for poses; donation to charitable institutions (3) Receives approval for their appli- must: Meet U.S. Grade No. 2 (fairly cation; clean) requirements as certified by the (4) Completes form FSA–118 and AMS or the Federal-State Inspection whose fresh Irish potatoes are shipped Service; and be in a quantity of 40,000 in accordance with this regulation; pounds net or a multiple of 40,000 (5) Diverts fresh Irish potatoes and pounds net. Only transportation costs submits required documentation by associated with donations to charitable July 28, 1997, if Form FSA–117 is ap- institutions may be arranged for and proved by USDA from May 29 through paid by USDA. USDA will make no July 11, 1997; or diverts fresh Irish po- other payment with respect to such po- tatoes and submits required docu- tatoes. mentation by August 13, 1997, if Form (b) Livestock feed payments will be FSA–117 is approved by USDA from $.75 per hundredweight for U.S. Grade July 14 through July 28, 1997; or diverts No. 2 Processing potatoes when whole fresh Irish potatoes and submits re- as certified by AMS or the Federal- quired documentation by August 27, State Inspection Service. Payment will 1997, if Form FSA–117 is approved by not be made for any fractional part of USDA from July 29 through August 27, a hundredweight not meeting grade re- 1997. Allocations unused by the applica- quirements. All arrangements and ble date will no longer be available for costs for: U.S. grading and inspection; that producer. Final dates to complete processing, and transportation, as well diversions and submit documentation as identifying the livestock feed recipi- may be waived by USDA if it is deter- ent will be included in the $.75 per hun- mined that severe weather conditions dredweight payment. USDA will make prevented the completion of the diver- no other payment with respect to such sion during the allotted time period. potatoes. (6) Files a claim as provided in § 80.10; and [62 FR 29650, June 2, 1997, as amended at 62 (7) Complies with all other terms and FR 40730, July 30, 1997] conditions in this subpart. § 80.6 Eligibility for payment. (b) In the event applications for par- ticipation in the program authorized (a) To the extent applications for by this subpart exceed $9 million, payment do not exceed $9 million, pay- USDA shall, at its sole discretion, de- ments will be made under this program termine which applications to accept. to any producer of fresh Irish potatoes who: [62 FR 29650, June 2, 1997, as amended at 62 (1) Provides fresh Irish potatoes that FR 40731, July 30, 1997] are free from any water damage and: (i) If intended for human consump- § 80.7 Application and approval for tion, meet the requirements of 7 CFR participation. 51.1540–51.3006 U.S. Grade No. 2 (fairly (a) The applications will be reviewed clean); or by the FSA in the order shown on the (ii) If intended for livestock feed, FSA register located at the respective meet the requirements of 7 CFR FSA county office and will be approved 51.3410–51.3418 U.S. Grade No. 2 Proc- taking into account the availability of essing when whole, and are cut, funds, for each method of diversion; chopped sliced, gouged, crushed, (b) An approved Form FSA–117 may ensiled, or cooked to the degree that be modified or amended with the con- the potatoes are readily and obviously sent of the applicant and the duly au- identifiable as having been rendered thorized representative of AMS or FSA unsuitable to enter into normal chan- provided that such modification or
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amendment does not conflict with the FSA–118, and a livestock feed recipient provisions of this subpart; and delivery receipt indicating hundred- (c) Copies of the applicable U.S. weight received, the date and name, ad- grade standards and the application for dress, and telephone number of the re- participation in the Fresh Irish Potato cipient. Diversion Program can be obtained from the local county FSA office. § 80.10 Compliance with program pro- visions. § 80.8 Inspection and certificate of di- If USDA determines that any provi- version. sions of the application or of these reg- Prior to diversion of potatoes to a ulations has not been complied with, charitable institution, the fresh Irish whether by the producer, charitable in- potatoes must be inspected by an in- stitution, or livestock feeder, or that spector authorized or licensed by the any quantity of fresh Irish potatoes di- USDA to inspect and certify the class, verted under this program was not used quality, and condition of fresh Irish po- exclusively for donation to charitable tatoes. The producer will be respon- institutions or livestock feeders sible for requesting and arranging for (whether such failure was caused di- inspection. For charitable institutions rectly by the producer or by any other the product must be Positive Lot Iden- person or persons), the producer will tification (PLI) or certified by USDA not be entitled to diversion payments grading personnel at time of loading. in connection with such fresh Irish po- With respect to potatoes diverted for tatoes, must refund any USDA pay- livestock feed, the producer must fur- ment made in connection with such nish to FSA such scale tickets, weigh- fresh Irish potatoes, and will also be ing facilities, or volume measurements liable to USDA for any other damages as determined by the inspector to be incurred as a result of such failure to necessary for ascertaining the net use the fresh Irish potatoes exclusively weight of the potatoes being diverted. for donation to charitable institutions or for use as livestock feed. The USDA § 80.9 Claim for payment. may deny any producer the right to (a) In order to obtain payment for participate in this program or the right shipments to charitable institutions, to receive payments in connection with the producer must submit to the coun- any diversion previously made under ty FSA office which approved the ap- this program, or both, if USDA deter- plication: A properly executed Form mines that: FSA–118; a copy of the Notice to De- (a) The producer has failed to use or liver sent from FSA, Kansas City Com- caused to be used any quantity of fresh modity Office, Kansas City, Missouri; a Irish potatoes diverted under this pro- bill of lading showing shipment was gram exclusively for donation to chari- made. All such claims must be filed no table institutions or livestock feed, later than 30 days after the termi- whether such failure was caused di- nation date specified in the applicable rectly by the producer or by any other approved application. For those pota- person or persons; toes which fail to meet the definition (b) The producer has not acted in of fresh Irish potatoes provided in § 80.3 good faith in connection with any or the eligibility requirements of § 80.6, transaction under this program; or the producer may request an appeal in- (c) The producer has failed to dis- spection; however, payment of the charge fully any obligation assumed by truck detention and storage charges him under this program. will be the responsibility of the pro- ducer. § 80.11 Inspection of premises. (b) Livestock feed payments will be The producer, charitable institution, based on the percentage of the offered or livestock feeder must permit au- fresh Irish potatoes meeting U.S. Grade thorized representatives of USDA, at No. 2 Processing. In order to obtain any reasonable time, to have access to payment the producer must submit to their premises to inspect and examine the county FSA office which approved such fresh Irish potatoes as are being the application a properly executed diverted or stored for diversion, and to
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inspect and examine the facilities for § 80.13 Offset and assignment. diverting fresh Irish potatoes to deter- (a) Except as provided in paragraph mine compliance with the provisions of (b) of this section, below, any payment this program. or portion thereof due any person shall § 80.12 Records and accounts. be allowed without regard to questions of title under state law, and without The producer, charitable institution, regard to any claim or lien against the or livestock feeder participating in this crop or proceeds thereof in favor of the program must keep accurate records owner or any other creditor, except for and accounts showing the details rel- statutory liens belonging to agencies of ative to the diversion and livestock the U.S. Government. The regulations feeding of the fresh Irish potatoes. The governing offsets and withholdings producer, charitable institution, or found at 7 CFR part 3 shall be applica- livestock feeder must permit author- ble to such payments. ized representatives of USDA and the (b) Assignments. Assignments will be General Accounting Office at any rea- done in accordance with Form FSA– sonable time to inspect, examine, and 117. make copies of such records and ac- counts to determine compliance with § 80.14 Appeals. provisions of this program; such Appeals under this part will be in ac- records and accounts must be retained cordance with 7 CFR part 780. for three years after the date of last payment to the producer under the pro- gram, or for 2 years after date of audit Subpart B [Reserved] of records by USDA as provided herein, whichever is the later. PART 81 [RESERVED]
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PART 90—INTRODUCTION (d) The granting of laboratory pro- gram accreditation or certification or Subpart A—Scope of Subchapter approval for specialty testing of agri- cultural commodities and products. Sec. (e) The licensing of chemists to ana- 90.1 General. lyze cottonseed in order to certify its quality and grade. Subpart B—Subchapter Definitions (f) The granting of certification to 90.2 General terms defined. non-federal laboratories for testing for trichinae in horsemeat for export to Subpart C—Good Laboratory Practices for the European Community (EC). Commodity Laboratory Analyses (g) The granting of acceptance of 90.3 General. standardized methodology or new pro- 90.4–90.100 [Reserved] cedures for commodity testing. (h) The auditing of the facilities, Subpart D—Quality Assurance equipment, quality control procedures, standard methodologies, and good lab- 90.101 General. 90.102 Quality assurance review. oratory practices for a commodity 90.103 Maintenance of quality control testing program of a laboratory. records. (i) The examination of plants for nov- 90.104–90.200 [Reserved] elty and distinctiveness in order to grant certificates of protection for new AUTHORITY: 7 U.S.C. 1622, 1624. varieties of sexually reproduced plants, SOURCE: 58 FR 42414, Aug. 9, 1993, unless and the provision of other fee based otherwise noted. services authorized by the Plant Vari- ety Protection Act. Subpart A—Scope of Subchapter (j) The extension or coordination of research for the determination of a new § 90.1 General. chemical analyte or microorganism in This subchapter sets forth the func- a commodity product or food. tions and responsibilities of the (k) The analysis of imported flue- Science and Technology (S&T) of the cured and burley tobacco for pesticide Agricultural Marketing Service (AMS) residues. relating to: (l) The supervision and implementa- (a) The performance of comprehen- tion of the State enforcement of the sive analytical tests and laboratory de- recordkeeping requirements for private terminations of agricultural commod- applicators of restricted-use pesticides ities and processed products. for agricultural production. (b) The conduct of experiments and collaborative studies to validate new [58 FR 42414, Aug. 9, 1993, as amended at 61 analytical procedures and improved FR 51350, Oct. 2, 1996; 65 FR 64309, Oct. 26, 2000] methodologies in order to promote faster, more precise, or safer labora- tory testing for agricultural commod- Subpart B—Subchapter Definitions ities and processed products. (c) The supervised issuance of exter- § 90.2 General terms defined. nal quality control or proficiency Words used in the regulations in this check samples to laboratories under subchapter in the singular form will the Science and Technology’s direction import the plural, and vice versa, as or performance review in order to regu- the case may demand. As used through- larly spot check and assess that ana- out the regulations in this subchapter lytical or test data produced by each and unless the context requires other- laboratory is reproducible, precise, and wise, the following terms will be con- reliable for a specific test program. strued to mean:
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Act. The Agricultural Marketing Act data produced is reproducible, precise, of 1946 (Title II of the act of Congress and accurate. approved August 14, 1946, 60 Stat. 1087– Quality control. The system of close 1091, as amended; 7 U.S.C. 1621–1627). examination of the critical details of Administrator. The Administrator of an analytical procedure in order to the Agricultural Marketing Service, or have the proper equipment parameters, any officer or employee of the Service, techniques, supplies and reagents to to whom authority has been delegated, achieve a predetermined level of qual- or to whom authority may be dele- ity data, with the performance of a gated, to act in his or her stead. particular laboratory analysis. Cooperative agreement. An agreement Secretary. The Secretary of Agri- between the Agricultural Marketing culture of the United States, or any of- Service and another Federal agency or ficer or employee of the Department to whom authority has heretofore been a State agency, or other agency, orga- delegated, or to whom authority may nization or person that defines in the hereafter be delegated, to act in his or general terms the basis on which the her stead. parties concerned will cooperate to Service. The Agricultural Marketing serve a mutual interest on an agricul- Service of the United States Depart- tural service project. The responsibil- ment of Agriculture. ities for AMS and each cooperator are stated in the document along with the [58 FR 42414, Aug. 9, 1993, as amended at 61 conditions as applicable. FR 51350, Oct. 2, 1996; 65 FR 64309, Oct. 26, 2000] Department. The United States De- partment of Agriculture. Deputy Administrator. The Deputy Ad- Subpart C—Good Laboratory ministrator of the Science and Tech- Practices for Commodity Lab- nology program of the Agricultural oratory Analyses Marketing Service agency, or any offi- § 90.3 General. cer or employee of this agency to whom authority has heretofore been Laboratory service programs of lab- delegated, or to whom authority may oratories certified and approved by the hereafter be delegated, to act. Science and Technology shall have Laboratories. Science and Technology good laboratory practice (GLP) re- laboratories performing the official quirements that are generalized in this analyses described in this subchapter. subpart. Program. The Science and Technology [58 FR 42414, Aug. 9, 1993, as amended at 61 (S&T) program of the Agricultural FR 51350, Oct. 2, 1996; 65 FR 64309, Oct. 26, Marketing Service (AMS) which per- 2000] forms official analytical testing serv- §§ 90.4–90.100 [Reserved] ices, issues licenses for cottonseed chemists, and conducts quality assur- Subpart D—Quality Assurance ance reviews and grants accreditation or certification for commodity testing § 90.101 General. programs of laboratories. Laboratory service programs of lab- Quality assurance. The assurance that oratories certified and approved by the there is accuracy of analytical data Science and Technology shall have using proficiency check sample or quality assurance requirements that analyte recovery techniques. In addi- are generalized in this subpart. tion, the certainty that there is strict [58 FR 42414, Aug. 9, 1993, as amended at 61 adherence by the analysts in following FR 51350, Oct. 2, 1996; 65 FR 64309, Oct. 26, the quality control details in the rec- 2000] ommended or official methods for re- agents, laboratory apparatus and pro- § 90.102 Quality assurance review. cedures. The overall objective of qual- (a) Each laboratory performing tests ity assurance, as a comprehensive pro- and analysis under this subchapter will gram, is to ensure that all analytical be subject to a quality assurance pro- data produced by the laboratory meets gram evaluation at least annually, and certain quality criteria and that all more often if deemed necessary by the
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Deputy Administrator. Such evalua- 91.3 Authority. tion will include: (1) A review of the adequacy of qual- Subpart B—General Services ity control measures taken by the lab- 91.4 Kinds of services. oratory for the standardized method of 91.5 Where services are offered. analysis for a commodity and its re- 91.6 Availability of services. lated products; (2) A review of the laboratory meth- Subpart C—Application for Services odologies and procedures; 91.7 Nondiscrimination. (3) A review of records for the cali- 91.8 Who may apply. bration and maintenance of equipment; 91.9 How to make an application. (4) A review of records documenting 91.10 Information required in connection sample handling; with an application. (5) The evidence of quality control 91.11 Filing of an application. records; 91.12 Record of filing time and laboratory (6) The evidence of correct reporting tests. and determination of analytical data. 91.13 When an application may be rejected. 91.14 When an application may be with- (b) A laboratory will receive a qual- drawn. ity assurance report following the re- view. This evaluation will address any Subpart D—Laboratory Service necessary improvements to the labora- tory program(s) being examined. 91.15 Basis of a laboratory service. 91.16 Order of a laboratory service. [58 FR 42414, Aug. 9, 1993, as amended at 65 91.17 Postponing a laboratory service. FR 64309, Oct. 26, 2000] 91.18 Financial interest of a scientist.
§ 90.103 Maintenance of quality con- Subpart E—Samples trol records. 91.19 General requirements of suitable sam- Quality control records pertaining, ples. but not limited to the following areas, 91.20 Shipping. shall be retained by the laboratory for 91.21 Protecting samples. at least the 3 most recent years: 91.22 Disposition of analyzed sample. (a) Prepared solution standardiza- tions; Subpart F—Method Manuals (b) Recovery studies by known 91.23 Analytical methods. analyte additions; (c) The purity checks of reagents and Subpart G—Reporting test materials; (d) Apparatus and equipment calibra- 91.24 Reports of test results. 91.25 Certificate requirements. tions; 91.26 Issuance of certificates. (e) The quality examination and test- 91.27 Corrections to certificates prior to ing of materials; issuance. (f) The mandatory participation in 91.28 Issuance of corrected certificates or proficiency check sample testing or amendments for analysis reports. collaborative studies; 91.29 Issuance of duplicate certificates or (g) Daily critical parameter checks of reissuance of an analysis report. equipment, such as temperature read- 91.30 Maintenance and retention of copies of certificates or analysis reports. ings; (h) The equivalency tests of new pro- Subpart H—Appeal of Laboratory Services cedures with standard methodologies. §§ 90.104–90.200 [Reserved] 91.31 When an appeal of a laboratory service may be requested. 91.32 Where to file for an appeal of a labora- PART 91—SERVICES AND GENERAL tory service and information required. INFORMATION 91.33 When an application for an appeal of a laboratory service may be withdrawn. Subpart A—Administration 91.34 When an appeal of a laboratory service may be refused. Sec. 91.35 Who shall perform an appealed labora- 91.1 General. tory service. 91.2 Definitions. 91.36 Appeal laboratory certificate.
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Subpart I—Fees and Charges iday by Federal Statute or Executive Order. Under section 6103 and Execu- 91.37 Standard hourly fee rate for labora- tive Order 10357, as amended, if the tory testing, analysis, and other services. 91.38 Additional fees for appeal of analysis. specified legal public holiday falls on a 91.39 Premium hourly fee rate for overtime Saturday, the preceding Friday shall and legal holiday service. be considered the holiday, or if the 91.40 Fees for courier service and facsimile specified legal holiday falls on a Sun- of the analysis report. day, the following Monday shall be 91.41 Charges for demonstrations and considered to be the holiday. courses of instruction. 91.42 Billing. [58 FR 42415, Aug. 9, 1993, as amended at 65 91.43 Payment of fees and charges. FR 64309, Oct. 26, 2000] 91.44 Charges on overdue accounts and issuance of delinquency notices. § 91.3 Authority. 91.45 Charges for laboratory services on a contract basis. The Deputy Administrator is charged with the administration of this sub- AUTHORITY: 7 U.S.C. 1622, 1624. chapter. SOURCE: 58 FR 42415, Aug. 9, 1993, unless [58 FR 42415, Aug. 9, 1993, as amended at 65 otherwise noted. FR 64309, Oct. 26, 2000] EDITORIAL NOTE: Nomenclature changes to part 91 appear at 61 FR 51350, Oct. 2 1996. Subpart B—General Services Subpart A—Administration § 91.4 Kinds of services. § 91.1 General. (a) Analytical tests. Analytical lab- oratory testing services under the reg- This part consolidates the procedural ulations in this subchapter consist of and administrative rules of the Science microbiological, chemical, and certain and Technology of the Agricultural other analyses, requested by the appli- Marketing Service for conducting the cant and performed on tobacco, seed, analytical testing and laboratory au- dairy, egg, fruit and vegetable, meat dits with quality assurance reviews. It and poultry products, and related proc- also contains the fees, charges and lab- essed products. Analyses are performed oratories applicable to such services. to determine if products meet Federal [58 FR 42415, Aug. 9, 1993, as amended at 65 specifications or specifications defined FR 64309, Oct. 26, 2000] in purchase contracts and cooperative agreements. Laboratory analyses are § 91.2 Definitions. also performed on egg products as part Words used in the regulations in this of the mandatory Egg Products Inspec- part in the singular form will import tion Program under the management the plural, and vice versa, as the case of USDA’s Food Safety and Inspection may demand. As used throughout the Service (FSIS) as detailed in 9 CFR regulations in this part, unless the con- 590.580. text requires otherwise, the following (b) Examination and licensure. The terms will be construed to mean: manager of the Science and Tech- Agency. The Agricultural Marketing nology’s Cottonseed Chemist Licensing Service agency of the United States Program administers examinations and Department of Agriculture. licenses chemists to certify the official Analyses. Microbiological, chemical, grade of cottonseed. or physical tests performed on a com- (c) Quality assurance reviews. The modity. Science and Technology representative Applicant. Any person or organization performs on-site laboratory quality as- requesting services provided by the surance reviews (both required and vol- Science and Technology (S&T) pro- untary) to ensure that appropriate grams. technical methods, equipment mainte- Legal holidays. Those days designated nance, and quality control procedures as legal public holidays specified by are being observed. Congress in paragraph (a) of section (d) Consultation. Technical advice, 6103, title 5 of the United States Code statistical science consultation, and and any other day declared to be a hol- quality assurance program assistance
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are provided by the representatives for (4) Program laboratories. Laboratory the Science and Technology programs services are available in all areas cov- for domestic and foreign laboratories. ered by cooperative agreements pro- viding for this laboratory work and en- [65 FR 64309, Oct. 26, 2000] tered on behalf of the Department with § 91.5 Where services are offered. cooperating Federal or State labora- tory agencies pursuant to authority (a) Services are offered to applicants contained in Act(s) of Congress. Also, at the Science and Technology labora- services may be provided in other areas tories and facilities in the following not covered by a cooperative agree- list: ment if the Administrator determines (1) Science and Technology regional that it is possible to provide such lab- laboratories. A variety of tests and lab- oratory services. oratory analyses are available in two (5) Other alternative laboratories. Lab- regional multi-disciplinary Science and oratory analyses may be conducted at Technology (S&T) laboratories, and are alternative Science and Technology located as follows: laboratories and can be reached from (i) USDA, AMS, S&T any commodity market in which a lab- Eastern Laboratory (Microbiology), oratory facility is located to the extent 2311–B Aberdeen Boulevard, Gas- laboratory personnel are available. tonia, NC 28054–0614. (6) The Plant Variety Protection (PVP) (ii) USDA, AMS, S&T Office. The PVP office and plant exam- Eastern Laboratory (Chemistry), 645 ination facility of the Science and Cox Road, Gastonia, NC 28054–0614. Technology programs issues certifi- (2) Science and Technology (S&T) cates of protection to developers of aflatoxin laboratories. The specialty lab- novel varieties of plants which repro- oratories performing aflatoxin testing duce sexually. The PVP office is lo- on peanuts, peanut products, dried cated as follows: USDA, AMS, Science fruits, grains, edible seeds, tree nuts, & Technology, Plant Variety Protec- shelled corn products, oilseed products tion Office, National Agricultural Li- and other commodities are located as brary Building, Room 500, 10301 Balti- follows: more Boulevard, Beltsville, MD 20705– (i) USDA, AMS, S&T 2351. 1211 Schley Avenue, Albany, GA (7) Science and Technology head- 31707. quarters offices. The examination, licen- (ii) USDA, AMS, S&T sure, quality assurance reviews, labora- c/o Golden Peanut Company, Mail: tory accreditation/certification and P.O. Box 279, 301 West Pearl Street, consultation services are provided by Aulander, NC 27805. headquarters staff located in Wash- (iii) USDA, AMS, S&T ington, DC. The main headquarters of- 610 North Main Street, Blakely, GA fice is located as follow: USDA, AMS, 31723. Science and Technology, Office of the (iv) USDA, AMS, S&T Deputy Administrator, Room 3507 107 South Fourth Street, Madill, OK South Agriculture Bldg., Mail Stop 73446. 0222, 1400 Independence Ave., S.W., (v) USDA, AMS, S&T Washington, DC 20250. c/o Cargill Peanut Products, Mail: (8) The Information Technology (IT) P.O. Box 272, 715 North Main Office. The IT office of the Science and Street, Dawson, GA 31742–0272. Technology programs is headed by (vi) USDA, AMS, S&T AMS’s Chief Information Officer (CIO) Mail: P.O. Box 1130, 308 Culloden and provides information technology Street, Suffolk, VA 23434. services and management systems to (3) Citrus laboratory. The Science and the Agency and other agencies within Technology’s citrus laboratory special- the USDA. The main IT office is lo- izes in testing citrus juices and other cated as follow: USDA, AMS, Science citrus products and is located as fol- and Technology, Office of the Chief In- lows: USDA, AMS, S&T Eastern Lab- formation Officer, 1752 South Agri- oratory (Citrus), 98 Third Street, S.W., culture Bldg., 1400 Independence Ave., Winter Haven, FL 33880. SW., Washington, DC 20250.
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(9) Statistical Branch office. The Sta- tions are satisfactory for the conduct tistical Branch office of Science and of such service. Technology (S&T) provides statistical (b) Laboratories may provide limited services to the Agency and other agen- service on Saturdays and Sundays at a cies within the USDA. In addition, the premium fee. Weekend service may be Statistical Branch office devices sam- obtained by contacting the laboratory ple plans and performs consulting serv- director or supervisor. ices for research studies in joint efforts (c) Holiday and overtime laboratory with or in a leading role with other service may be obtained with a min- program areas of AMS or of the USDA. imum 24 hour advance notice, at a pre- The main Statistical Branch office is mium fee, by any prospective applicant located as follow: USDA, AMS, S&T through the laboratory director or su- Statistical Branch, 0611 South Agri- pervisor. culture Bldg., 1400 Independence Ave., S.W., Washington, DC 20250. [58 FR 42415, Aug. 9, 1993, as amended at 65 (10) Offices for Pesticide Residue Pro- FR 64310, Oct. 26, 2000] grams. Services afforded by the Federal Pesticide Record Keeping Program for Subpart C—Application for restricted-use pesticides by certified Services applicators and services afforded by the Pesticide Data Program (PDP) are pro- § 91.7 Nondiscrimination. vided by offices located as follows: All services under these regulations (i) USDA, AMS, Science and Tech- are provided to applicants without dis- nology crimination as to race, color, handi- Pesticide Data Branch, 8700 Centre- capped or disabled condition, religion, ville Road, Suite 200, Manassas, VA sex, age, or national origin. 20110–8411 (ii) USDA, AMS, Science and Tech- § 91.8 Who may apply. nology Pesticide Records Branch, 8700 Cen- An application for service may be treville Road, Suite 202, Manassas, made by any individual or interested VA 20110–8411 party including, but not limited to, the (iii) USDA, AMS, Science and Tech- United States and any instrumentality nology or agency thereof, any State, county, Office of Deputy Administrator, municipality, or common carrier, and Room 3507 South Agriculture Bldg., any authorized agent on behalf of the 1400 Independence Ave., SW., Wash- foregoing. ington, DC 20250. § 91.9 How to make an application. (b) The addresses of the various lab- oratories and offices appear in the per- (a) Voluntary. An application for tinent parts of this subchapter. A pro- analysis and testing may be made by spective applicant may obtain a cur- contacting the director or supervisor of rent listing of addresses and telephone the Science and Technology laboratory numbers of Science and Technology where the service is provided, or by laboratories, offices, and facilities by contacting the Technical Services addressing an inquiry to the Adminis- Branch Chief at Science and Tech- trative Officer, Science and Tech- nology Headquarters, Washington, DC. nology, Agricultural Marketing Serv- A list of the Science and Technology ice, United States Department of Agri- laboratories is included in § 91.5. culture (USDA), P.O. Box 96456, Room (b) Mandatory. In the case of manda- 0727 South Building, Mail Stop 0271, tory analyses, such as those required Washington, D.C. 20090–6456. to be performed on eggs and egg prod- ucts, application for services may be [65 FR 64310, Oct. 26, 2000] submitted to the office or USDA agen- § 91.6 Availability of services. cy which administers the program, or by contacting an inspector or grader (a) Services may be furnished when- who is involved with the program. ever a Science and Technology staff is available and the facilities and condi- [65 FR 64310, Oct. 26, 2000]
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§ 91.10 Information required in con- (4) When the samples are received in nection with an application. an unsatisfactory condition and are re- (a) An application for laboratory jected for analysis, service shall be made in the English (5) When there is evidence or knowl- language and may be made orally (in edge of tampering with the sample, person or by telephone), in writing, or (6) When it appears that to perform by facsimile. If an application for lab- the analytical testing or laboratory oratory service is made orally, written service specified in this part would not confirmation may be required by the be to the best interests of the public laboratory involved. welfare or of the Government, or (b) In connection with each applica- (7) When it appears to the Adminis- tion for a laboratory service, informa- trator that prior commitments of the tion that may be necessary to perform Department necessitate rejection of analyses on the processed product(s) the application. shall also be furnished. The informa- (b) Each such applicant shall be tion shall include, but is not limited promptly notified by registered mail of to, the name of the product, name and the reasons for the rejection. address of the packer or plant where (c) A written petition for reconsider- such product was packed, the location ation of such rejection may be filed by of the product, its lot or load number, the applicant with the Administrator if codes or other identification marks, postmarked or delivered within 10 days the number of containers, the type and after the receipt of notice of the rejec- size of the containers, the analytical tion. Such petition shall state specifi- test requested, and the size of the sam- cally the errors alleged to have been ple. In addition, information regarding made by the Administrator in rejecting analysis of the lot by any federal agen- the application. Within 20 days fol- cy previous to the application and the lowing the receipt of such a petition purpose of the desired laboratory serv- for reconsideration, the Administrator ice may be requested. shall approve the application or notify the applicant by registered mail of the § 91.11 Filing of an application. reasons for the rejection thereof. An application for a laboratory serv- ice shall be regarded as filed only when § 91.14 When an application may be withdrawn. made in accordance with the regula- tions in this part. An application for a laboratory serv- ice may be withdrawn by the applicant § 91.12 Record of filing time and lab- at any time before the analytical test- oratory tests. ing is performed; Provided, That, the A record showing the date of receipt applicant shall pay, at the hourly rate for each application for a laboratory prescribed in § 91.37, for the time in- service or an appeal of a laboratory curred by the scientist or laboratory service shall be maintained. In addi- technician, in connection with such ap- tion, the requested laboratory analyses plication and any travel expenses, tele- shall be recorded at the time of sample phone, facsimile, mailing, telegraph or receipt. other expenses, which have been in- curred by the laboratory servicing of- § 91.13 When an application may be re- fice, in connection with such applica- jected. tion. (a) An application for a laboratory service may be rejected by the Admin- Subpart D—Laboratory Service istrator when deemed appropriate as follows: § 91.15 Basis of a laboratory service. (1) For non-compliance by the appli- Analytical testing and laboratory de- cant with the regulations in this part, termination for analyte or quality con- (2) For non-payment of previous lab- stituent shall be based upon the appro- oratory services rendered, priate standards promulgated by the (3) When the sample is not properly U.S. Department of Agriculture, appli- identified by a code or other marks, cable standards prescribed by the laws
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of the State where the particular prod- (2) Lot number or production date; uct was produced, specifications of any (3) Analyses desired; governmental agency, written buyer (4) Date/time collected; and seller contract specifications, or (5) Storage conditions prior to ship- any written specifications by an appli- ping; cant which is approved by the Adminis- (6) Name of applicant; trator; Provided, That, if such product (7) Name of sampler; is regulated pursuant to the Agricul- tural Marketing Agreement Act of 1937, (8) Any other information which is as amended (7 U.S.C. 601 et seq.), or the required by the specific program under comparable laws of any State, such which analysis or test is performed. testing and determination shall be on the basis of the standards, if any, pre- § 91.20 Shipping. scribed in, or pursuant to, the mar- (a) Samples must be submitted to the keting order and/or agreement effec- laboratory in a condition (including tive thereunder. temperature) that does not com- promise the quality and validity of an- § 91.16 Order of a laboratory service. alytical results. Laboratory service shall be per- (b) All samples must be submitted in formed, insofar as possible, in the order sealed, leakproof containers. in which applications are made except (c) Containers for perishable refrig- that precedence may be given to any erated samples should contain ice or such applications which are made by ice packs to maintain temperatures of the United States (including, but not 0° to 5 °C, unless a different tempera- being limited to, any instrumentality ture is required for the sample to be or agency thereof) and to any applica- tested. tion for an appeal inspection. (d) Containers for frozen samples should contain dry ice or other effec- § 91.17 Postponing a laboratory serv- ice. tive methods of maintaining samples in a frozen state. If the scientist determines that it is (e) The applicant is responsible for not possible to accurately analyze or providing shipping containers and pay- make a laboratory determination of a ing shipping costs for fee basis tests. sample immediately after receipt be- (f) A courier charge may apply for cause standard materials, laboratory the shipment of some samples. equipment and supplies need replace- ment, or for any other substantial rea- § 91.21 Protecting samples. son, the scientist may postpone labora- tory service for such period as may be Laboratory personnel shall protect necessary. each sample from manipulation, sub- stitution, and improper or careless § 91.18 Financial interest of a scientist. handling which would deprive the sam- No scientist shall perform a labora- ple of its representative character from tory analysis on any product in which the time of receipt in the laboratory he is directly or indirectly financially until the analysis is completed and the interested. sample has been discarded.
Subpart E—Samples § 91.22 Disposition of analyzed sample. (a) Excess samples not used in anal- § 91.19 General requirements of suit- yses will be placed in proper storage for able samples. a maximum period of 30 days after re- (a) Samples must be representative porting results of tests. of the product tested and provided in (b) Any sample of a processed com- sufficient quantity for the analyses re- modity that has been used for a labora- quested. tory service may be returned to the ap- (b) Each sample must be identified plicant at his or her request and ex- with the following information: pense; otherwise, it shall be destroyed (1) Product type (specific descrip- or disposed of to a charitable institu- tion); tion.
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Subpart F—Method Manuals II, AOAC INTERNATIONAL, 481 North Frederick Avenue, Suite 500, Gaithers- § 91.23 Analytical methods. burg, MD 20877–2417. Most analyses are performed accord- (i) Standard Analytical Methods of ing to approved procedures described in the Member Companies of Corn Indus- manuals of standardized methodology. tries Research Foundation, Corn Refin- These standard methods are the spe- ers Association (CRA), 1701 Pennsyl- cific methods used. Alternatively, vania Avenue, NW., Washington, DC equivalent methods prescribed in coop- 20006. erative agreements are used. The (j) Standard Methods for the Exam- manuals of standard methods most ination of Dairy Products, American often used by the Science and Tech- Public Health Association, 1015 Fif- nology laboratories are listed as fol- teenth Street, NW., Washington, DC lows: 20005. (a) Approved Methods of the Amer- (k) Standard Methods for the Exam- ican Association of Cereal Chemists ination of Water and Wastewater, (AACC), American Association of Ce- American Public Health Association real Chemists/Eagan Press, 3340 Pilot (APHA), the American Water Works Knob Road, St. Paul, Minnesota 55121– Association (AWWA) and the Water 2097. Pollution Control Federation, AWWA (b) ASTA’s Analytical Methods Man- Bookstore, 6666 West Quincy Avenue, ual, American Spice Trade Association Denver, CO 80235. (ASTA), 560 Sylvan Avenue, P.O. Box (l) Test Methods for Evaluating Solid 1267, Englewood Cliffs, New Jersey Waste Physical/Chemical Methods, En- 07632. vironmental Protection Agency, Office (c) Compendium Methods for the of Solid Waste, SW–846 Integrated Man- Microbiological Examination of Foods, ual (available from National Technical Carl Vanderzant and Don Information Service (NTIS), U.S. De- Splittstoesser (Editors), American Pub- partment of Commerce, 5285 Port lic Health Association, 1015 Fifteenth Royal Road, Springfield, VA 22161). Street, NW., Washington, DC 20005. (m) U.S. Army Natick Research, De- (d) Edwards, P.R. and W.H. Ewing, velopment and Engineering Center’s Edwards and Ewing’s Identification of Military Specifications, approved ana- Enterobacteriaceae, Elsevier Science, lytical test methods noted therein, Inc., Regional Sales Office, 655 Avenue Code NPP–9, Department of Defense of the Americas, P.O. Box 945, New Single Stock Point (DODSSP) for Mili- York, NY 10159–0945. tary Specifications, Standards, Build- (e) FDA Bacteriological Analytical ing 4/D, 700 Robbins Avenue, Philadel- Manual (BAM), AOAC INTER- phia, PA 19111–5094. NATIONAL, 481 North Frederick Ave- (n) U.S. Food and Drug Administra- nue, Suite 500, Gaithersburg, MD 20877– tion, Pesticide Analytical Manuals 2417. (PAM), Volumes I and II, Food and (f) Manual of Analytical Methods for Drug Administration, Center for Food the Analysis of Pesticide Residues in Safety and Applied Nutrition (CFSAN), Human and Environmental Samples, 200 C Street, SW., Washington, DC 20204 EPA 600/9–80–038, U.S. Environmental (available from National Technical In- Protection Agency (EPA) Chemical Ex- formation Service (NTIS), U.S. Depart- posure Research Branch, EPA Office of ment of Commerce, 5285 Port Royal Research and Development (ORD), 26 Road, Springfield, VA 22161). West Martin Luther King Drive, Cin- cinnati, Ohio 45268. [65 FR 64310, Oct. 26, 2000] (g) Official Methods and Rec- ommended Practices of the American Subpart G—Reporting Oil Chemists’ Society (AOCS), Amer- ican Oil Chemists’ Society, P.O. Box § 91.24 Reports of test results. 3489, 2211 West Bradley Avenue, Cham- (a) Results of analyses are provided, paign, Illinois 61821–1827. in writing, by facsimile, by e-mail or (h) Official Methods of Analysis of other electronic means to the appli- AOAC INTERNATIONAL, Volumes I & cant.
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(b) Applicants may call the appro- fice or laboratory of the Science and priate Science and Technology labora- Technology program; tory for interim or final results prior (3) A person designated as the ‘‘lab- to issuance of the formal report. The oratory director in charge,’’ when the advance results may be telegraphed, e- certificate represents composite anal- mailed, telephoned, or sent by fac- yses by several technicians. simile to the applicant. Any additional (b) The laboratory certificate shall expense for advance information shall be prepared in accordance with the be borne by the requesting party. facts set forth in the official memo- (c) A letter report in lieu of an offi- randa made by the scientist or techni- cial certificate of analysis may be cians in connection with the analysis. issued by a laboratory representative (c) Whenever a certificate is signed when such action appears to be more by a person under a power of attorney, suitable than a certificate: Provided, the certificate should so indicate. The that, issuance of such report is ap- signature of the holder of power shall proved by the Deputy Administrator. appear under the name of the scientist [65 FR 64311, Oct. 26, 2000] who personally analyzed the sample, and whenever a certificate issued is § 91.25 Certificate requirements. signed by a scientist in charge, that Certificates of analysis and other title must appear in connection with memoranda concerning laboratory the signature. service and the reporting of results [58 FR 42415, Aug. 9, 1993, as amended at 65 should have the following require- FR 64311, Oct. 26, 2000] ments: (a) Certificates of analysis shall be on § 91.27 Corrections to certificates prior standard printed forms approved by the to issuance. Deputy Administrator; (a) The accuracy of the statements (b) Shall be printed in English; and information shown on certificates (c) Shall have results typewritten, of analysis must be verified by the in- computer generated, or handwritten in dividual whose name or signature, or ink and shall be clearly legible; both, is shown on the certificate or by (d) Shall show the results of labora- the authorized agent who affixed the tory tests in a uniform, accurate, and name or signature, or both. When a concise manner with abbreviations name or signature, or both, is affixed identified on the form; by an authorized agent, the initials of (e) Shall show the information re- the agent shall appear directly below quired by §§ 91.25–91.29; and or following the name, or signature of (f) Show only such other information the person. Errors found during this and statements of fact as are provided process shall be corrected according to in the instructions authorized by the this section. Deputy Administrator. (b) Only official personnel or their [58 FR 42415, Aug. 9, 1993, as amended at 65 authorized agents may make correc- FR 64311, Oct. 26, 2000] tions, additions, or other changes to certificates. § 91.26 Issuance of certificates. (c) No corrections, additions, or other (a) The person signing and issuing changes shall be made which involve the certificate of analysis shall be one identification, quality, or quantity. If of the following: such errors are found, a new certificate (1) The scientist who performed the shall be prepared and issued and the in- analysis; correct certificate marked ‘‘Void.’’ (2) Another technician of the labora- Otherwise, errors may be corrected, tory facility, who has been given power provided there is evidence of satisfac- of attorney by the scientist who per- tory correction procedures as follows: formed the analytical testing and been (1) The corrections are neat and leg- authorized by the Deputy Adminis- ible; trator to affix the scientist’s signature (2) Each correction is initialed by the to a certificate. The power of attorney individual who corrects the certificate; shall be on file with the employing of- and
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(3) The corrections and initials are § 91.29 Issuance of duplicate certifi- shown on the original and all copies. cates or reissuance of an analysis report. § 91.28 Issuance of corrected certifi- (a) Upon request by an applicant, a cates or amendments for analysis duplicate certificate or an additional reports. report may be issued for a lost, de- (a) A corrected certificate of analysis stroyed, or otherwise not obtainable or an amended letter report may be original form. issued by the laboratory representative (b) The duplicate certificate or the who issued the original certificate or reissuance of an analysis report shall report after distribution of the form if be at the expense of the applicant. errors, such as incorrect dates, analyt- (c) Requests for duplicate certificates ical results, or test determination or additional analysis reports shall be filed as follows: statements, lot numbers, or errors in (1) In writing; any other pertinent information re- (2) By the applicant who requested quire the issuance of a corrected cer- the service covered by the lost, de- tificate or an amended report. stroyed, or otherwise not obtainable (b) Whenever a corrected certificate original form; and or amended report is issued, such cer- (3) With the office that issued the ini- tificate or report shall supersede the tial certificate or original laboratory original form which was issued in analysis report. error. The superseded certificate or in- (d) The duplicate certificates or re- correct report shall become null and issued analysis reports shall show the void after the issuance of the corrected following: certificate or the amended analysis re- (1) The terms ‘‘Duplicate Original,’’ port. and the copies shall show ‘‘Duplicate (c) The corrected certificates or Copy,’’ amended reports shall show the fol- (2) A statement that the certificate lowing: or letter report was issued in lieu of a lost or destroyed or otherwise not ob- (1) The terms ‘‘Corrected Original’’ tainable certificate or laboratory anal- and ‘‘Corrected Copy;’’ ysis report; and (2) A statement identifying the su- (3) The same statements and infor- perseded certificate or incorrect letter mation, including permissive state- report and the corrections; ments, that were shown on the original (3) A new serial number or new date certificate or the initial analysis re- of issuance; and port shall be shown on the duplicate (4) The same statements and infor- form. mation, including permissive state- (e) Duplicate certificates or duplicate ments, that were shown on the incor- analysis reports shall be issued as rect certificate or the incorrect report, promptly as possible and distributed as along with the correct statement or in- the original certificates or original formation, shall be shown on the cor- analysis reports and their copies. rected form. (f) Duplicate certificates shall not be (d) If all copies of the incorrect cer- issued for certificates that have been tificate or incorrect report can be ob- superseded. tained, then the superseded form shall § 91.30 Maintenance and retention of be marked ‘‘Void’’ when submitted. copies of certificates or analysis re- (e) Corrected certificates or amended ports. letter reports cannot be issued for a (a) At least one copy of each certifi- certificate that has been superseded by cate or analysis report shall be filed in another certificate, or superseded on the laboratory for a period of not less the basis of a subsequent analysis or an than 3 years either from the date of additional laboratory test determina- issuance of the document, from the tion. date of voiding a certificate, or from
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the date last payment is made by the § 91.32 Where to file for an appeal of a applicant for a reported laboratory de- laboratory service and information termination, whichever is later. required. (b) Whenever any document, because (a) Application for an appeal of a lab- of its condition, becomes unsuitable for oratory service may be filed with the its intended or continued use, the lab- supervisor in the office or the director oratory personnel shall make a copy of of the laboratory facility that issued the original document. the certificate or laboratory report on (c) True copies shall be retained as which the appeal analysis covering the photocopies, microfilm, microfiche, or commodity product is requested. other accurate reproductions and dura- (b) The application for an appeal of a ble forms of the original document. laboratory service shall state the loca- Where reduction techniques, such as tion of the lot of the commodity prod- microfilming are used, suitable reader uct and the reasons for the appeal; and and photocopying equipment shall be date and serial number of the certifi- readily available. Such reproductions cate covering the laboratory service of shall be treated and considered for all the commodity product on which the purposes as though they were the origi- appeal is requested. In addition, such nal documents. (d) All documents required to be application shall be accompanied by maintained under this part shall be the original and all available copies of kept confidential and shall be disclosed the certificate or laboratory report. only to the applicants or other persons (c) Application for an appeal of a lab- with the applicants’ knowledge and oratory service may be made orally (in permission. Only such information as person or by telephone), in writing, by the Administrator deems relevant shall e-mail, by facsimile, or by telegraph. If be disclosed to the public without the made orally, written confirmation applicants’ permission, and then, only shall be made promptly. in a suit or administrative hearing [65 FR 64311, Oct. 26, 2000] brought at the direction, or on the re- quest, of the Administrator, or to § 91.33 When an application for an ap- which the Administrator or any other peal of a laboratory service may be officer of the United States is a party. withdrawn. An application for an appeal of a lab- Subpart H—Appeal of Laboratory oratory service may be withdrawn by Services the applicant at any time before the appealed laboratory service is per- § 91.31 When an appeal of a laboratory formed; Provided, That, the applicant service may be requested. shall pay, at the hourly rate prescribed (a) An application for an appeal of a in § 91.37, for the time incurred by the laboratory service may be made by any laboratory personnel, any travel, tele- interested party who is dissatisfied phone, telegraph, or other expenses with the results of an analysis as stat- which have been incurred by the lab- ed in a certificate or laboratory report, oratory service in connection with if the lot of the commodity can be posi- such application. tively identified by the laboratory service as the lot from which originally § 91.34 When an appeal of a laboratory drawn samples were previously ana- service may be refused. lyzed. An application for an appeal of a lab- (b) An application for an appeal of a oratory service may be refused if: laboratory service shall be made within (a) The reasons for the appealed lab- thirty (30) days following the day on oratory service are frivolous or not which the previous analysis was per- substantial; formed. However, upon approval by the (b) The quality or condition of the Deputy Administrator, the filing time commodity product has undergone a for an appeal application may be ex- material change since the laboratory tended. service covering the commodity prod- [58 FR 42415, Aug. 9, 1993, as amended at 65 uct on which the appealed laboratory FR 64311, Oct. 26, 2000] service is requested;
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(c) The lot in question is not, or can- Subpart I—Fees and Charges not be made accessible for sampling; (d) The lot relative to which the ap- § 91.37 Standard hourly fee rate for pealed laboratory service is requested laboratory testing, analysis, and cannot be positively identified as the other services. lot from which samples were previously (a) The standard hourly fee rate in drawn and originally analyzed; or this section for the individual labora- (e) There is noncompliance with the tory analyses cover the costs of regulations in this part. Such applicant Science and Technology laboratory shall be notified promptly of the reason services, including issuance of certifi- for such refusal. cates and personnel and overhead costs other than the commodity inspection § 91.35 Who shall perform an appealed fees referred to in 7 CFR §§ 52.42 laboratory service. through 52.46, 52.48 through 52.51, 55.510 An appealed laboratory service shall through 55.530, 55.560 through 55.570, be performed, whenever possible, by an- 58.38 through 58.43, 58.45 through 58.46, other individual or other individuals 70.71 through 70.72, and 70.75 through than the scientist(s) or the techni- 70.78. The hourly fee rates in this part cian(s) that performed the original an- 91 apply to all processed commodity alytical determination. products, except flue-cured and burley tobacco, and exclude aflatoxin anal- § 91.36 Appeal laboratory certificate. yses, citrus juices and certain citrus (a) An appeal laboratory certificate products. The printed updated sched- shall be issued showing the results of ules of the laboratory testing fees for such appealed analysis. This certificate processed fruits and vegetables (7 CFR shall supersede the laboratory certifi- part 93), poultry and egg products (7 cate previously issued for the com- CFR part 94), and meat and meat prod- modity product involved. ucts (7 CFR part 98) will be available for distribution by the individual Lab- (b) Each appeal laboratory certificate oratory Directors of Science and Tech- shall clearly identify the number and nology laboratories listed in § 91.5. The date of the laboratory certificate which updated schedules of the laboratory it supersedes. The superseded certifi- testing fees are also available for elec- cate shall become null and void upon tronic access on the world wide web the issuance of the appealed laboratory (www) site at: http://ams.usda.gov/ certificate and shall no longer rep- science. The fees for chemical analysis resent the analytical results of the of cottonseed associated with grading commodity product. and novel variety seed certification (c) The individual issuing an appeal under the Plant Variety Protection laboratory certificate shall forward no- Act are specified in 7 CFR parts 96 and tice of such issuance to such persons as 97, respectively. Except as otherwise he or she considers necessary to pre- provided in this section, charges will be vent misuse of the superseded certifi- made for laboratory analysis at the cate if the original and all copies of standard hourly rate of $45.00 for the such superseded certificate have not time required to perform the service. A previously been delivered to the indi- minimum charge of one-quarter hour vidual issuing the appeal certificate. at $11.25 will be made for service pursu- (d) The provisions in the regulations ant to each request or certificate in this part concerning forms and cer- issued. tificates, issuance of certificates, and (b) When a laboratory test service is retention and disposition of certifi- provided for AMS by a commercial or cates shall apply to appeal laboratory State government laboratory, the ap- certificates, except that copies of such plicant will be assessed a fee which appeal certificates shall be furnished to covers the costs to the Science and all interested parties who received cop- Technology program for the service ies of the superseded certificate. provided.
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(c) When Science and Technology TABLE 3—SINGLE TEST LABORATORY FEES FOR staff provides applied and develop- FOOD ADDITIVES (DIRECT AND INDIRECT)— mental research and training activities Continued for microbiological, physical and chem- ical analyses on agricultural commod- Type of analysis List fee ities the applicant will be charged a fee Antibiotic, Qualitative (Dairy) ...... 22.50 on a reimbursable cost basis. Antibiotic, Quantitative ,1N ...... 393.75 Ascorbates (Qualitative—Meats) ...... 22.50 Ascorbic Acid, Titration ...... 45.00 GENERAL SCHEDULES OF FEES FOR OFFI- Ascorbic Acid, Spectrophotometric ...... 45.00 CIAL LABORATORY TEST SERVICES Brix, Direct Percent Sucrose ...... 22.50 PERFORMED AT THE AMS SCIENCE AND Brix, Dilution ...... 22.50 TECHNOLOGY LABORATORIES FOR PROC- Butylated Hydroxyanisole (BHA) ...... 67.50 Butylated Hydroxytoluene (BHT) ...... 67.50 ESSED COMMODITY PRODUCTS Caffeine, Micro Bailey-Andrew ...... 67.50 Caffeine, Spectrophotometric ...... 78.75 TABLE 1—SINGLE TEST LABORATORY FEES FOR Citric Acid, GLC or HPLC ...... 67.50 PROXIMATE ANALYSES Chlorinated Hydrocarbons: Pesticides and Industrial Chemicals— Type of analysis List fee Initial Screen ...... 180.00 Second Column Confirmation of Analyte ...... 45.00 Ammonia, Ion Selective Electrode ...... $101.25 Confirmation on Mass Spectrometer (Per Ash, Total ...... 45.00 Residue) ...... $90.00 Chloride, Salt Titration (Dairy) ...... 22.50 Dextrin (Qualitative) ...... 22.50 Fat, Acid Hydrolysis (Cheese) ...... 45.00 Dextrin (Quantitative) ...... 135.00 Fat, Acid Hydrolysis (Mojonnier) ...... 45.00 Filth, Heavy (Dairy) ...... 112.50 Fat (Dairy Products except Cheese) ...... 22.50 Filth, Heavy (Eggs) ...... 180.00 Fat (Dry Basis) ...... 67.50 Filth, Light (Eggs) ...... 112.50 Fat, Ether Extraction (Soxhlet) ...... 45.00 Filth, Light & Heavy (Eggs Extraneous) ...... 270.00 Fat (Kohman Analysis) ...... 45.00 Fines ...... 22.50 Fat, Microwave—Solvent Extraction ...... 45.00 Flavor (Dairy) ...... 11.25 Moisture, Distillation ...... 45.00 Flavor (Products except Dairy) ...... 33.75 Moisture, Oven ...... 22.50 Fumigants: Moisture (Kohman Analysis) ...... 11.25 Initial Screen— Protein, Combustion ...... 90.00 Dibromochloropropane (DBCP) ...... 45.00 Protein, Kjeldahl ...... 90.00 Ethylene Dibromide ...... 45.00 Salt, Back Titration ...... 33.75 Methyl Bromide ...... 45.00 Salt, Potentiometric ...... 22.50 Confirmation on Mass Spectrometer— Salt (Rapid) ...... 33.75 Each individual fumigant residue ...... $90.00 Glucose (Qualitative) ...... 33.75 Glucose (Quantitative) ...... 78.75 TABLE 2—SINGLE TEST LABORATORY FEES FOR Glycerol (Quantitative) ...... 135.00 Gums ...... 135.00 LIPID RELATED ANALYSES Heavy Metal Screen 2 ...... 326.25 Mercury, Cold Vapor AA ...... 135.00 Type of analysis List fee Monosodium Dihydrogen Phosphate ...... 180.00 Monosodium Glutamate ...... 180.00 Acid Degree Value (Dairy) ...... $45.00 Niacin ...... 90.00 Acidity, Titratable ...... 22.50 Ochratoxin A ...... 67.50 Density (Specific Gravity) ...... 11.25 Odor ...... 11.25 Dispersibility (Instant Dry Whole Milk) ...... 67.50 Organic Acids (in Eggs) ...... 180.00 Dispersibility (Moates-Dabbah Method) ...... 22.50 Oxygen ...... 22.50 1 Fat Stability, AOM ...... 45.00 Palatability and Odor: Each Sample ...... 22.50 Fatty Acid Profile (AOACÐGC method) ...... 180.00 Penicillin ...... 67.50 Flash Point Test only ...... 90.00 Pyrethrin Residue (Dairy) ...... 180.00 Free Fatty Acids ...... 22.50 Scorched Particles ...... 22.50 Meltability (Process Cheese) ...... 22.50 Sodium, Potentiometric ...... 45.00 Peanut Oil Analyses (Oil, Moisture, Free Fatty Sodium Benzoate, HPLC ...... 67.50 Acids, Ammonia, and Foreign Matter) ...... 45.00 Sodium Lauryl Sulfate (SLS) ...... 360.00 Any One of the Oilseed Oil Analyses ...... 22.50 Sodium Silicoaluminate (Zeolex) ...... 90.00 Peroxide Value ...... 33.75 Solubility Index ...... 11.25 Smoke Point Test only ...... 90.00 Starch, Direct Acid Hydrolysis ...... 90.00 Smoke Point and Flash Point ...... 157.50 Starch (in Dry Milk) ...... 22.50 Solids, Total (Oven Drying) ...... 22.50 Sugar, Polarimetric Methods ...... 33.75 Soluble Solids, Refractometer ...... 22.50 Sugar Profile, HPLC— 3 One type sugar from HPLC profile ...... 135.00 1 Peroxide value analysis is required as a prerequisite to the fat stability test at the additional fee. Each additional type sugar ...... 22.50 Sugars, Non-Reducing ...... 135.00 Sulfur Dioxide, Direct Titration ...... 45.00 TABLE 3—SINGLE TEST LABORATORY FEES FOR Toluene, Residual ...... 90.00 FOOD ADDITIVES (DIRECT AND INDIRECT) Vitamin A, Carr-Price (Dairy) ...... 112.50 Vitamin A, HPLC ...... 90.00 Type of analysis List fee Vitamin B1 (Thiamin) ...... 90.00 Vitamin B2 (Riboflavin) ...... 90.00 Amitraz Residue, GLC ...... $112.50 Vitamin D, HPLC (Vitamins D2 and D3), Dairy ...... 382.50
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TABLE 3—SINGLE TEST LABORATORY FEES FOR TABLE 5—SINGLE TEST LABORATORY FEES FOR FOOD ADDITIVES (DIRECT AND INDIRECT)— MICROBIOLOGICAL ANALYSES—Continued Continued Type of analysis List fee Type of analysis List fee Listeria monocytogenes Confirmation Analysis 6: Whey Protein Nitrogen ...... 33.75 Step 1 ...... 67.50 Whey Protein Nitrogen, Kjeldahl ...... 112.50 Step 2 ...... 56.25 Xanthydrol Test For Urea ...... 67.50 Step 3 (Confirmation) ...... 112.50 This is an optional test to the extraneous mate- Parasite Identification ...... 180.00 rials isolation test. Psychrotrophic Bacterial Plate Count ...... 45.00 Salmonella (USDA Culture Method) 7: 1 Antibiotic testing includes tests for chlorotetracycline, oxy- Step 1 ...... 78.75 tetracycline, and tetracycline. 2 Heavy metal screen includes tests for cadmium, lead, and Step 2 ...... 33.75 mercury. Step 3 (Confirmation) ...... 56.25 3 This profile includes the following components: Dextrose, Salmonella Enumeration (Complete Test) ...... 135.00 Fructose, Lactose, Maltose and Sucrose. Salmonella (Rapid Methods) 8: Step 1 ...... 78.75 TABLE 4—SINGLE TEST LABORATORY FEES FOR Step 2 ...... 33.75 OTHER CHEMICAL AND PHYSICAL COMPONENT Step 3 (Confirmation) ...... 56.25 Salmonella typhi (Meat Products) 9 ...... 45.00 NALYSES A Staphylococcus aureus, Direct Plating ...... 67.50 Staphylococcus aureus, MPN: With Coagulase Type of analysis List fee Positive Confirmation ...... 78.75 Cheese(Fines) ...... $11.25 Thermoduric Bacterial Plate Count ...... 33.75 Color, Apparent-Visual ...... 11.25 Yeast and Mold Count ...... 22.50 Complete Kohman Analysis (Dairy) ...... 45.00 Yeast and Mold Differential Confirmation ...... 22.50 Hot Water Insolubles ...... $67.50 Yeast and Mold Differential Plate Count ...... 33.75 Linolenic Acid ...... 90.00 Yeast or Mold Confirmation ...... 22.50 Net Weight (Per Can) ...... 11.25 1 Coliform MPN analysis may be in two steps as follows: Non-Volatile Methylene Chloride Extract ...... 112.50 Step 1—presumptive test through lauryl sulfate tryptose broth; Overrun for Whipped Topping ...... 33.75 Step 2—confirmatory test through brilliant green lactose bile Particle Size (Ether Wash) ...... 22.50 broth. 2 pH ...... 11.25 Step 1 of the coliform MPN analysis is a prerequisite for the performance of the presumptive E. coli test. Prior enrich- pH—Quinhydrone (Cheese) ...... 22.50 ment in lauryl sulfate tryptose broth is required for optical re- Potassium Iodide (Table Salt) ...... 67.50 covery of E.coli from inoculated and incubated EC broth Protein Reducing Substances ...... 45.00 (Escherichia coli broth). The E. coli test is performed through Quinic Acid (Cranberry Juice) ...... 78.75 growth on eosin methylene blue agar. The fee stated for E. Serum Drainage for Whipped Topping ...... 22.50 coli analysis is a supplementary charge to step 1 of coliform Sieve or Particle Size ...... 22.50 test. 3 β Rate of Wetting (Nondairy Creamer) ...... 22.50 In the presence of the substrate 4-methylumbelliferone- - D-glucuronide (MUG), the enzyme β-glucuronidase, which is Reducing Sugars ...... 90.00 found in the majority of E. coli strains, produces a fluorogenic Water Activity ...... 22.50 end product which is visible under ultraviolet (UV) light. Water Insoluble Inorganic Residues (WIIR) ...... 90.00 4 Howard Mold Count involves counting mold filaments in commodity products. 5 Determination of bacterial plate count of different species TABLE 5—SINGLE TEST LABORATORY FEES FOR of Lactobacillus. 6 Listeria monocytogenes test using the USDA method may MICROBIOLOGICAL ANALYSES be in three steps as follows: Step 1—isolation by University of Vermont modified (UVM) broth and Fraser’s broth enrich- Type of analysis List fee ments and selective plating with Modified Oxford (MOX) agar; Presumptive Step 2—typical colonies inoculated from Horse Aerobic (Standard) Plate Count ...... $22.50 Blood into brain heart infusion (BHI) broth and check for char- Anaerobic Bacterial Plate Count ...... 33.75 acteristic motility; Confirmatory Step 3—culture from BHI broth with typical motility is inoculated into the seven biochemical Bacillus cereus ...... 90.00 medias, BHI agar for oxidase and catalase tests, Motility test Bacterial Direct Microscopic Count ...... 45.00 medium, and Christie-Atkins-Munch-Peterson (CAMP) test. Coliform Plate Count (Dairy Products) ...... 22.50 Listeria monocytogenes test using the FDA method may be Coliform Plate Count, Violet Red Bile Agar (Pre- in three steps as follows: Step 1—isolation by trypticase soy sumptive Coliform Plate Count) ...... 33.75 broth with 0.6% yeast extract (TSBÐYE) broth enrichment and Coliforms, Most Probable Number (MPN) 1: selective plating with Modified McBrides agar and Lithium chloride Phenylethanol Moxalactam (LPM) agar; Presumptive Step 1 ...... 33.75 Step 2—typical colonies inoculated to trypticase soy agar with Step 2 ...... 22.50 yeast extract (TSAÐYE) with sheep blood plates to check for Direct Microscopic Clump Count—(Field Sub- hemolysis followed by inoculations to BHI broth and TSAÐYE mitted Smears, Less Than or Equal To 75 Mil- plates to check for characteristic motility, gram stain and cata- lion Count) ...... 11.25 lase test; Confirmatory Step 3—culture from BHI broth with Direct Microscopic Clump Count—(Field Sub- typical motility for wet mount is inoculated into the required 10 biochemical medias, Sulfide-Indole-Motility (SIM) medium, and mitted Smears, Greater Than 75 Million Count) 45.00 the CAMP test. Serology is checked using growth from TSAÐ Direct Microscopic Clump Count—(Lab Prepared YE plates. Smears) ...... 45.00 Both methods for Listeria determination have the equivalent E. coli, Presumptive MPN (Additional) 2 ...... $45.00 time needed for each step. E. coli (MUG 3) ...... 33.75 7 Salmonella test may be in three steps as follows: Step 1— Enterococci Count ...... 135.00 growth through differential agars; Step 2—growth and testing 4 through triple sugar iron and lysine iron agars; Step 3— con- Howard Mold Count ...... 56.25 firmatory test through biochemicals, and polyvalent serological Lactobacillus Count 5 ...... 56.25 testing with Poly ‘‘O’’ and Poly ‘‘H’’ antiserums. The sero- Lactic Acid Tolerant Microbes ...... 22.50 logical typing of Salmonella is requested on occasion.
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8 Salmonella test may be in three steps as follows: Step 1— 9 Salmonella typhi determination in mechanically deboned growth in enrichment broths and ELISA test or DNA hybridiza- meat. tion system assay; Step 2—growth and testing through triple sugar iron and lysine iron agars; Step 3—confirmatory test through biochemicals, and polyvalent serological testing with Poly ‘‘O’’ and Poly ‘‘H’’ antiserums.
TABLE 6—LABORATORY FEES FOR AFLATOXIN ANALYSES
Aflatoxin test by commodity Single Pair analysis analyses 1
Peanut Butter (TLCÐCB, HPLC, Affinity Column) ...... $45.00 2 NA Corn (TLCÐCB, HPLC, Affinity Column) ...... 45.00 NA Roasted Peanuts (TLCÐBF) ...... 45.00 NA Brazil Nuts (TLCÐBF) ...... 90.00 NA Pistachio Nuts (TLCÐBF, HPLC) ...... 90.00 NA Shelled Peanuts (TLC, Affinity Column) ...... 45.00 $38.00 Shelled Peanuts (HPLC) ...... 45.00 70.00 Tree Nuts (TLC) ...... 45.00 NA Oilseed Meals (TLC, HPLC, Affinity Column) ...... $45.00 NA Edible Seeds (TLC) ...... 45.00 NA Dried Fruit (TLC) ...... 45.00 NA Small Grains (TLC) ...... 45.00 NA In-Shell Peanuts Affinity Column (TLC) ...... 45.00 38.00 In-Shell Peanuts (HPLC) ...... 45.00 70.00 Silage; Other Grains (TLC) ...... 45.00 NA Submitted Samples (TLC, HPLC, Affinity Column) ...... 45.00 NA Aflatoxin (Dairy, Eggs) ...... 157.50 NA 1 Aflatoxin testing of raw peanuts under Peanut Marketing Agreement for subsamples 1ÐAB, 2ÐAB, 3ÐAB, and 1ÐCD for single or pair of analyses is $19.00 or $38.00, respectively using Thin-Layer Chromatography (TLC) and Best Foods (BF) extraction or immunoaffinity column assay with fluorometric quantitation. The BF method has been modified to incorporate a water slurry ex- traction procedure. The Contaminants Branch (CB) method is used on occasion as an alternative method for peanuts and peanut meal when doubt exists as to the effectiveness of the Best Foods method in extracting aflatoxin from the sample or when back- ground interferences exist that might mask TLC quantitation of aflatoxin. The cost per single or pair of analyses using High Pres- sure Liquid Chromatography (HPLC) is $35.00 and $70.00, respectively. Other aflatoxin for fruits and vegetables are listed at Science and Technology’s current hourly rate of $45.00. 2 NA denotes not applicable.
TABLE 7—MISCELLANEOUS CHARGES SUPPLEMENTAL TO THE SCIENCE AND TECHNOLOGY’S LABORATORY ANALYSIS FEES
Laboratory service description List fee
Sample Grinding by Vertical Cutter Mixer (VCM) ...... $22.50 Sample Grinding Canned Boned Poultry ...... $11.25 per can. Sample Grinding by Dickens Hammer Mill ...... $11.25. Sample Grinding (Meats, Meat Products, Meals, Ready-to-Eat): Per pouch or raw sample ...... $11.25. Per tray pack ...... $22.50. Composting Multiple Subsamples for an Individual Test Sample Unit per subsample ...... Varies—Preparation fee based on $45.00 per hour.
TABLE 8—ADDITIONAL CHARGES APPLICABLE TO THE SAMPLE RECEIPT AND ANALYSIS REPORT
Service description List charge
Courier Expense at Other AMS Laboratories: Mileage Charge Set at 32.5¢ Per Mile Varies (based on total mileage). Round Trip from Laboratory to Delivery Site. Facsimile Charge (Per Analysis Report) ...... $3.20 minimum up to first 3 pages, then $1.50 per page. Additional Analysis Report or Extra Certificate (1⁄2 hour charge) ...... $22.50 per report or certificate re- issued.
[65 FR 64311, Oct. 26, 2000] a result of an authorized appeal anal- ysis, it is determined that the original § 91.38 Additional fees for appeal of test results are correct. The appeal lab- analysis. oratory rate is $67.50 per analysis hour. (a) The appellant will be charged an (b) The appeal fee will be waived if additional fee at a rate of 1.5 times the the appeal laboratory test discloses standard rate stated in § 91.37 (a) if, as
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that an inadvertent error was made in § 91.42 Billing. the original analysis. (a) Each billing cycle will end on the [65 FR 64314, Oct. 26, 2000] 25th of the month. The applicant will be billed by the National Finance Cen- § 91.39 Premium hourly fee rate for ter using the Billings and Collections overtime and legal holiday service. System (BLCO) on the 1st day, fol- (a) Laboratory analyses initiated at lowing the end of the billing cycle in the special request of the applicant to which voluntary laboratory services be rendered on Saturdays, Sundays, and other services were rendered at a Federal holidays, and on an overtime particular Science and Technology lab- basis will be charged at a rate of 1.5 oratory. times the standard rate stated in § 91.37 (b) The total charge shall normally (a). The premium laboratory rate for be stated directly on the analysis re- holiday and overtime service will be port or on a standardized official cer- tificate form for the laboratory anal- $67.50 per analysis hour. yses of a specific agricultural com- (b) Information on legal holidays or modity and related commodity prod- what constitutes overtime service at a ucts. particular S&T laboratory is available (c) The actual bill for collection will from the Laboratory Director or facil- be issued by the USDA, National Fi- ity supervisor. nance Center Billings and Collection [65 FR 64314, Oct. 26, 2000] Branch, (Mail: P.O. Box 60075), 13800 Old Gentilly Road, New Orleans, Lou- § 91.40 Fees for courier service and isiana 70160–0001. facsimile of the analysis report. [65 FR 64314, Oct. 26, 2000] (a) The Science and Technology lab- oratories have a courier charge per trip § 91.43 Payment of fees and charges. to retrieve the sample package. The (a) Fees and charges for services shall courier service charge is determined be paid by the applicant, by check or from the established single standard money order payable, to the ‘‘Agricul- mileage rate and from the total au- tural Marketing Service, USDA’’ and thorized distance based on the shortest sent to the office indicated on the bill. round trip route from laboratory to (b) Fees and charges for services sample retrieval site. Pursuant to the under a cooperative agreement with a requirements of paragraph (a) (1) of State or other AMS programs or other § 5704 of Title 5, United States Code governmental agency will be paid in (U.S.C.), the automobile reimburse- accordance with the terms of the coop- ment rate cannot exceed the single erative agreement. standard mileage rate established by (c) As necessary, the Deputy Admin- the Internal Revenue Service (IRS). istrator may require that fees shall be (b) The faxing of laboratory analysis paid in advance of the performance of reports or certificates is an optional the requested service. Any fees paid in service for each S&T facility offered at excess of the amount due shall be used a fee specified in table 8 in § 91.37. to offset future billings, unless a re- quest for a refund is made by applicant. [65 FR 64314, Oct. 26, 2000] [58 FR 42415, Aug. 9, 1993, as amended at 65 § 91.41 Charges for demonstrations FR 64315, Oct. 26, 2000] and courses of instruction. § 91.44 Charges on overdue accounts Charges, not in excess of the cost and issuance of delinquency no- thereof and as approved by the Deputy tices. Administrator, may be made for dem- (a) Accounts are considered overdue onstrations, samples, or courses of in- if payment is late with the National struction when such are furnished upon Finance Center (NFC). The timeliness request. of a payment will be based on the post- [58 FR 42415, Aug. 9, 1993, as amended at 65 mark date of the payment or the date FR 64314, Oct. 26, 2000] of receipt by the NFC if no postmark
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date is present or legible. Bills are pay- Understanding (MOU) or agreement able upon receipt and become delin- with any administrative agency or gov- quent 30 days from date of billing. erning party for the performance of (b) Any amount due not paid by the laboratory services pursuant to said due date will be increased by a late agreement or order on a basis that will payment charge. The actual assessed reimburse the Agricultural Marketing rate applied to overdue accounts is set Service of the Department for the full quarterly by the Department of the cost of rendering such laboratory serv- Treasury. This amount is one-twelfth ice, including an appropriate overhead of one year’s late penalty interest rate administrative overhead charge. computed at the prescribed rate. (c) The conditions and terms for re- (c) Overtime or holiday laboratory newal of such Memorandum of Under- service will not be performed for any standing or agreement shall be speci- applicant with a notice of delinquency. fied in the contract. (d) Applicants with three notices of [65 FR 64315, Oct. 26, 2000] delinquency will be reviewed for pos- sible termination of services. A deposit in advance sufficient to cover the fees PART 92—TOBACCO and expenses for any subsequent serv- ice may be required of any person fail- Sec. 92.1 General. ing to pay in claim after issuance of 92.2 Definitions. such notice of delinquency. 92.3 Location for laboratory testing and (e) The Deputy Administrator of S&T kind of services available. program and personnel of the USDA, 92.4 Approved forms for reporting analyt- NFC Billings and Collections Branch ical results. (address as listed in § 91.42) will take 92.5 Analytical methods. such actions as may be necessary to 92.6 Cost for pesticide analysis set by coop- collect any delinquent amounts due for erative agreement. accounts in claim status. AUTHORITY: 7 U.S.C. 511m, 511r. [58 FR 42415, Aug. 9, 1993, as amended at 65 SOURCE: 58 FR 42424, Aug. 9, 1993, unless FR 64315, Oct. 26, 2000] otherwise noted.
§ 91.45 Charges for laboratory services § 92.1 General. on a contract basis. Analytical testing of imported flue- (a) Irrespective of hourly fee rates cured and burley tobacco is performed and charges prescribed in § 91.37, or in for maximum allowable pesticide res- other sections of this subchapter E, the idue levels. Domestic grown tobacco Deputy Administrator may enter into may also be analyzed for pesticide resi- contracts with applicants to perform dues at the Science and Technology’s continuous laboratory services or other Eastern Laboratory facility. types of laboratory services pursuant [58 FR 42424, Aug. 9, 1993, as amended at 61 to the regulations in this part and FR 51350, Oct. 2, 1996, 61 FR 55840, Oct. 29, other requirements, as prescribed by 1996; 65 FR 64315, Oct. 26, 2000] the Deputy Administrator in such con- tract. In addition, the charges for such § 92.2 Definitions. laboratory services, provided in such Words used in the regulations in this contracts, shall be on such basis as will part in the singular form will import reimburse the Agricultural Marketing the plural, and vice versa, as the case Service of the Department for the full may demand. As used throughout the cost of rendering such laboratory serv- regulations in this part, unless the con- ices, including an appropriate overhead text requires otherwise, the following charge to cover administrative over- terms will be construed to mean: head expenses as may be determined by Air-cured. Tobacco cured under nat- the Administrator. ural atmospheric conditions. Artificial (b) Irrespective of hourly fee rates heat is sometimes used to control ex- and charges prescribed in this subpart cess humidity during the curing period I, or in other parts of this subchapter to prevent house-burn, barn-burn and E, the Deputy Administrator may pole-burn in damp weather. Air-cured enter into a written Memorandum of tobacco should not carry the odor of
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smoke or fumes resulting from the ap- Formothion. The common name for plication of artificial heat. the organophosphorus pesticide S-(2- AMS. The abbreviations for the Agri- (Formylmethylamino)-2-oxoethyl) O-O- cultural Marketing Service (AMS) dimethyl phosphorodithioate. agency of the United States Depart- HCB. The common abbreviation for ment of Agriculture. the organochlorine pesticide Burley. A thin to medium-bodied to- Hexachlorobenzene. bacco, usually a light tan to reddish- Lot. A unit of shipment of tobacco brown in color. encompassed by a single invoice. The Burley, Type 93. That type of air- lot may represent a pile, basket, bulk, cured tobacco commonly known as for- hack, burden, or more than one bale, eign-grown Burley, produced in coun- case, hogshead, tierce, package, or tries other than the United States. other definite package unit. Certificate of Analysis (Form TB–92). A Maximum pesticide residue level. The legal document on which the confirmed maximum concentration of residue al- test results for official samples will be lowable for a specific pesticide or com- testified to be correct by a Science and bination of pesticides, as set forth in 7 Technology chemist in charge of test- CFR 29.427 by the AMS Deputy Admin- ing. istrator of the Tobacco Programs. Cured. Tobacco dried of its sap by ei- Pesticide. Any substance or mixture ther natural or artificial processes. of substances intended for preventing, destroying, repelling, or mitigating 2,4-D. The common abbreviation for any pest, and any substance or mixture the acid herbicide 2,4- of substances intended for use as a Dichlorophenoxyacetic acid. plant regulator, defoliant, or desiccant. DBCP. The common abbreviation for Pesticide certification. A document the volatile fumigant pesticide 1,2– issued by the Tobacco Programs in a Dibromo-3-chloropropane. form approved by its AMS Deputy Ad- DDE. The common abbreviation for ministrator, containing a certification the chlorinated pesticide by the importer that flue-cured and Dichlorodiphenyldichloroethylene. burley tobacco offered for importation Degradation product of DDT by loss of does not exceed the maximum allow- one molecule of hydrochloric acid or able residue levels of any pesticide that referred to as a dehydrohalogenation has been canceled, suspended, revoked, process. or otherwise prohibited under the Fed- DDT. The common abbreviation for eral Insecticide, Fungicide, and Dichloro diphenyl trichloroethane or Rodenticide Act (FIFRA). the common name for the chlorinated Pesticide test sample. An official sam- insecticide or contact poison 1,1–Bis(p- ple or samples, collected from a lot of chlorophenyl)-2,2,2-trichloroethane. tobacco by the AMS Tobacco Programs Dicamba. The common name for the inspector for analysis by a certified acid herbicide 2-Methoxy-3,6- chemist to ascertain the residue levels dichlorobenzoic acid. of pesticides that have been canceled, EDB. The common abbreviation for suspended, revoked, or otherwise pro- Ethylene dibromide or the common hibited under the FIFRA. name for the volatile fumigant pes- Sample Identification Form (Form TB– ticide 1,2–Dibromoethane. 89). A document titled ‘‘Imported To- Flue-cured. Tobacco cured under arti- bacco Pesticide Residue Analysis’’ that ficial atmospheric conditions by a is approved by the AMS Deputy Admin- process of regulating the heat and ven- istrator of the Tobacco Programs that tilation without allowing smoke or identifies and accompanies the sample fumes from the fuel to come in contact to the testing facility. with the tobacco; or tobacco cured by 2,4,5-T. The common abbreviation for some other process which accomplishes the acid herbicide 2,4,5- the same results. Trichlorophenoxyacetic acid. Flue-cured, Type 92. That type of flue- TDE. DDD or the common abbrevia- cured tobacco commonly known as tion for the chlorinated insecticide 1,1- Foreign-grown Flue-cured, produced in Dichloro-2,2-bis(p-chlorophenyl)ethane countries other than the United States. (CAS number 72–54–8).
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Testing. The chemical analysis of a bicides such as 2,4-D, 2,4,5-T, and pesticide test sample to determine the Dicamba. presence and levels of pesticide resi- [65 FR 64315, Oct. 26, 2000] dues. Tobacco. Tobacco as it appears be- § 92.4 Approved forms for reporting tween the time it is cured and stripped analytical results. from the stalk, or primed and cured, in (a) Form TB–89, ‘‘Imported Tobacco whole leaf or strip form, and the time Pesticide Residue Analysis’’ certifi- it enters into the different manufac- cate, is enclosed with and identifies the turing processes. Conditioning, sweat- sample submitted to the laboratory. ing, stemming, and threshing are not (b) Test results of the pesticide anal- regarded as manufacturing processes. yses for tobacco shall be recorded on Tobacco, as used in this part, does not ‘‘Certificate of Analysis For Official include manufactured or semi-manu- Samples’’, Form TB–92, and shall be ex- factured products, stems, cuttings, pressed as parts by weight of the res- clippings, trimmings, siftings, or dust. idue per one million parts by weight of [58 FR 42424, Aug. 9, 1993, as amended at 65 the tobacco sample (parts per million FR 64315, Oct. 26, 2000] or ppm), which concentration is rep- resentative for each particular pes- § 92.3 Location for laboratory testing ticide residue found in the lot of to- and kind of services available. bacco. Form TB–92 is attached to Form (a) The analytical testing of im- TB–89 that is returned to the AMS To- ported Type 92 flue-cured tobacco sam- bacco Programs. The analytical data ples and imported Type 93 burley to- on Form TB–92 substantiates the infor- bacco samples for maximum pesticide mation placed on Form TB–89. residue level determinations is per- [58 FR 42424, Aug. 9, 1993, as amended at 65 formed at the AMS Science and Tech- FR 64316, Oct. 26, 2000] nology’s Eastern Laboratory, and is lo- cated at: USDA, AMS, Science and § 92.5 Analytical methods. Technology, Eastern Laboratory Every chemist certified to analyze (Chemistry), 645 Cox Road, Gastonia, tobacco samples for pesticide residue NC 28054–0614. contamination shall follow precisely (b) Domestic-grown tobacco and to- the USDA developed analytical test bacco products may be analyzed for methods and all successive official acid herbicides, chlorinated hydro- method updates, as approved by the carbons, fumigants, and AMS Deputy Administrator, Science organophosphates at the Science and and Technology. Many of the official Technology facility in this section. analyses for tobacco are found in the (c) The Science and Technology facil- following manuals: ity performs for the AMS Tobacco Pro- (a) Manual of Analytical Methods for grams the quantitative and confirm- the Analysis of Pesticide Residues in atory chemical residue analyses on pes- Human and Environmental Samples, ticide test samples of imported tobacco EPA 600/9–80–038, U.S. Environmental for the following specific pesticides: Protection Agency (EPA) Chemical Ex- (1) Organochlorine pesticides such as posure Research Branch, EPA Office of Dichloro-diphenyldichloroethylene Research and Development (ORD), 26 (DDE), Dichloro Diphenyl Trichloro- West Martin Luther King Drive, Cin- ethane (DDT), 1,1-Dichloro-2,2-bis(p- cinnati, Ohio 45268. chlorophenyl)ethane (TDE), (b) Official Methods of Analysis of Toxaphene, Endrin, Aldrin, Dieldrin, AOAC INTERNATIONAL, Volumes I & Heptachlor, Methoxychlor, Chlordane, II, AOAC INTERNATIONAL, 481 North Heptachlor Epoxide, Frederick Avenue, Suite 500, Gaithers- Hexachlorobenzene (HCB), burg, MD 20877–2417. Cypermethrin, and Permethrin. (2) (c) U.S. Food and Drug Administra- Organophosphorus pesticides such as tion, Pesticide Analytical Manuals Formothion. (3) Fumigants such as (PAM), Volumes I and II, Food and Ethylene Dibromide (EDB) and Dibro- Drug Administration, Center for Food mochloropropane (DBCP). (4) Acid her- Safety and Applied Nutrition (CFSAN),
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200 C Street, SW, Washington, DC 20204 Subpart A—Citrus Juices and (available from National Technical In- Certain Citrus Products formation Service (NTIS), U.S. Depart- ment of Commerce, 5285 Port Royal § 93.1 General. Road, Springfield, VA 22161). Domestic and imported citrus prod- [65 FR 64316, Oct. 26, 2000] ucts are tested to determine whether quality and grade standards are satis- § 92.6 Cost for pesticide analysis set by fied as set forth in the Florida Citrus cooperative agreement. Code. The fee for the pesticide analysis of § 93.2 Definitions. tobacco is set by the AMS Tobacco Words used in the regulations in this Programs, in conjunction with the subpart in the singular form will im- AMS Science and Technology program, port the plural, and vice versa, as the and appears at 7 CFR 29.500 as part of case may demand. As used throughout Tobacco Programs’ fees for sampling the regulations in this subpart, unless and certification of imported flue- the context requires otherwise, the fol- cured and burley tobacco. A Memo- lowing terms will be construed to randum of Understanding (MOU) exists mean: between the Tobacco Programs and the Acid. The grams of total acidity, cal- Science and Technology (S&T) for the culated as anhydrous citric acid, per testing of imported tobacco samples 100 grams of juice or citrus product. for pesticide residue contamination, Total acidity is determined by titra- and the corresponding agreement on tion with standard sodium hydroxide the cost of analyses is specified in the solution, using phenolphthalein as in- MOU. dicator. Brix or degrees Brix. The percent by [65 FR 64316, Oct. 26, 2000] weight concentration of the total solu- ble solids of the juice or citrus product PART 93—PROCESSED FRUITS AND when tested with a Brix hydrometer VEGETABLES calibrated at 20 °C (68 °F) and to which any applicable temperature correction has been made. The Brix or degrees Subpart A—Citrus Juices and Certain Citrus Brix may be determined by any other Products method which gives equivalent results. Sec. Brix value. The pure sucrose or solu- 93.1 General. ble solids value of the juice or citrus 93.2 Definitions. product determined by using the re- 93.3 Analyses available and location of lab- fractometer along with the ‘‘Inter- oratory. national Scale of Refractive Indices of 93.4 Analytical methods. Sucrose Solutions’’ and to which the 93.5 Fees for citrus product analyses set by applicable correction for acidity is cooperative agreement. added. The Brix value is determined in accordance with the refractometer Subpart B—Peanuts, Tree Nuts, Corn and method outlined in the Official Meth- Other Oilseeds ods of Analysis of AOAC INTER- NATIONAL, Volumes I & II. 93.10 General. Brix value/acid ratio. The ratio of the 93.11 Definitions. Brix value of the juice or citrus prod- 93.12 Analyses available and locations of uct, in degrees Brix, to the grams of laboratories. anhydrous citric acid per 100 grams of 93.13 Analytical methods. 93.14 Fees for aflatoxin analysis and fees for juice or citrus product. testing of other mycotoxins. Brix/acid ratio. The ratio of the de- 93.15 Fees for analytical testing of oilseeds. grees Brix of the juice to the grams of anhydrous citric acid per 100 grams of AUTHORITY: 7 U.S.C. 1622, 1624. the juice. SOURCE: 61 FR 51351, Oct. 2, 1996, unless Citrus. All plants, edible parts and otherwise noted. commodity products thereof, including pulp and juice of any orange, lemon,
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lime, grapefruit, mandarin, tangerine, INTERNATIONAL, Volumes I & II, kumquat or other tree or shrub in the AOAC INTERNATIONAL, 481 North genera Citrus, Fortunella, or Poncirus of Frederick Avenue, Suite 500, Gaithers- the plant family Rutaceae. burg, MD 20877–2417. Recoverable oil. The percent of oil by (b) Other analytical methods for cit- volume, determined by the bromate ti- rus products may be used as approved tration method after distillation and by the AMS Deputy Administrator, acidification as described in the cur- Science and Technology (S&T). rent edition of the Official Methods of [65 FR 64317, Oct. 26, 2000] Analysis of AOAC INTERNATIONAL, Volumes I & II. § 93.5 Fees for citrus product analyses set by cooperative agreement. [61 FR 51351, Oct. 2, 1996, as amended at 65 FR 64316, Oct. 26, 2000] The fees for the analyses of fresh cit- rus juices and other citrus products § 93.3 Analyses available and location shall be set by mutual agreement be- of laboratory. tween the applicant, the State of Flor- (a) Laboratory analyses of citrus ida, and the AMS Deputy Adminis- juice and other citrus products are trator, Science and Technology pro- being performed at the following grams. A Memorandum of Under- Science and Technology location: standing (MOU) or cooperative agree- USDA, AMS, S&T Eastern Laboratory ment exists presently with the AMS (Citrus), 98 Third Street, SW., Winter Science and Technology and the State Haven, FL 33880. of Florida, regarding the set hourly (b) Laboratory analyses of citrus rate and the costs to perform indi- fruit and products in Florida are avail- vidual analytical tests on Florida cit- able in order to determine if such com- rus products, for the State. modities satisfy the quality and grade [65 FR 64317, Oct. 26, 2000] standards set forth in the Florida Cit- rus Code (Florida Statutes Pursuant to Subpart B—Peanuts, Tree Nuts, Chapter 601). Such analyses include tests for acid as anhydrous citric acid, Corn and Other Oilseeds Brix, Brix/acid ratio, recoverable oil, § 93.10 General. and artificial coloring matter additive, Chemical analyses are performed to as turmeric. The Fruit and Vegetable detect the presence of aflatoxin in lots Inspectors of the Division of Fruit and of shelled peanuts and peanut products, Vegetable of the Florida Department of as well as in other nuts and agricul- Agriculture and Consumer Services tural products. In addition, proximate may also request analyses for arsenic chemical analyses for quality deter- metal, pulp wash (ultraviolet and fluo- mination are performed on oilseeds. rescence), standard plate count, yeast with mold count, and nutritive sweet- § 93.11 Definitions. ening ingredients as sugars. (c) There are additional laboratory Words used in the regulations in this tests available upon request at the subpart in the singular form will im- Science and Technology Eastern (Cit- port the plural, and vice versa, as the rus) Laboratory at Winter Haven, Flor- case may demand. As used throughout ida. Such analyses include tests for vi- the regulations in this subpart, unless tamins, naringin, sodium benzoate, Sal- the context requires otherwise, the fol- monella, protein, salt, pesticide resi- lowing terms will be construed to dues, sodium metal, ash, potassium mean: metal, and coliforms for citrus prod- Aflatoxin. A toxic metabolite pro- ucts. duced by the molds Aspergillus flavus, Aspergillus parasiticus, and Aspergillus [65 FR 64316, Oct. 26, 2000] nomius. The aflatoxin compounds fluo- resce when viewed under UV light as § 93.4 Analytical methods. follows: aflatoxin B1 and derivatives (a) The majority of analytical meth- with a blue fluorescence, aflatoxin B2 ods for citrus products are found in the with a blue-violet fluorescence, Official Methods of Analysis of AOAC aflatoxin G1 with a green fluorescence, 232
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aflatoxin G2 with a green-blue fluores- (3) USDA, AMS, S&T cence, aflatoxin M1 with a blue-violet 610 North Main Street, Blakely, GA fluorescence, and aflatoxin M2 with a 31723. violet fluorescence. These closely re- (4) USDA, AMS, S&T lated molecular structures are referred 107 South Fourth Street, Madill, OK to as aflatoxin B1, B2, G1, G2, M1, M2, 73446. GM1, B2a, G2a, R0, B3, 1-OCH3B2, and 1- (5) USDA, AMS, S&T CH3G2. c/o Cargill Peanut Products, Mail: Peanut Administrative Committee P.O. Box 272, 715 North Main (PAC). The committee established Street, Dawson, GA 31742–0272. under the United States Department of (6) USDA, AMS, S&T Agriculture Marketing Agreement for Mail: P.O. Box 1130, 308 Culloden Peanuts, 7 CFR part 998, which admin- Street, Suffolk, VA 23434. isters the terms and provisions of this (b) Peanuts, peanut products, and oil- Agreement, including the aflatoxin seed testing services. control program for domestically pro- (1) The Science and Technology duced raw peanuts, for peanut shellers. (S&T) Aflatoxin Laboratories at The Peanut Administrative Committee Madill, Oklahoma and Blakely, Geor- (PAC) headquarters are at 2537 Lafay- gia will perform other analyses for pea- ette Plaza Drive Suite A; Albany, Geor- nuts, peanut products, and a variety of gia 31707. oilseeds. The analyses for oilseeds in- Peanut Marketing Agreement. The clude testing for free fatty acids, am- agreement concerning the regulations monia, nitrogen or protein, moisture and instructions set forth since July 12, and volatile matter, foreign matter, 1965, by the Peanut Administrative and oil (fat) content. Committee for the marketing of pea- (2) All of the analyses described in nuts entered into by handlers of domes- paragraph (b)(1) of this section per- tically produced peanuts under the au- formed on a single seed sample are thority of the Agricultural Marketing billed at the rate of one hour per sam- Agreement Act of 1937, as amended (7 ple. Any single seed analysis performed U.S.C. 601 et seq.). on a single sample is billed at the rate Peanuts. The seeds of the legume of one-half hour per sample. The stand- Arachis hypogaea, and includes both ard hourly rate shall be as specified in inshell and shelled nuts. § 91.37(a) of this subchapter. Seed. Any vegetable or other agricul- (c) Vegetable oil testing services. The tural plant ovule having an embryo analyses for vegetable oils are per- that is capable of germinating to formed at the USDA, AMS, Science and produce a plant. Technology (S&T) Midwestern Labora- [61 FR 51351, Oct. 2, 1996, as amended at 63 FR tory, 3570 North Avondale Avenue, Chi- 16375, Apr. 2, 1998; 66 FR 64317, Oct. 26, 2000] cago, IL 60618–5391. The analyses for vegetable oils will include the flash § 93.12 Analyses available and loca- point test, smoke point test, acid tions of laboratories. value, peroxide value, phosphorus in (a) Aflatoxin testing services. The oil, and specific gravity. The fee aflatoxin analyses for peanuts, peanut charged for any single laboratory anal- products, dried fruits, grains, edible ysis for vegetable oils shall be obtained seeds, tree nuts, shelled corn products, from the Midwestern Laboratory Direc- cottonseed, oilseed products and other tor and it is based on the hourly fee commodities are performed at the fol- rates and charges as specified in 7 CFR lowing 6 locations for AMS Science and part 91, subpart I. Technology (S&T) Aflatoxin Labora- [65 FR 64317, Oct. 26, 2000] tories: (1) USDA, AMS, S&T § 93.13 Analytical methods. 1211 Schley Avenue, Albany, GA Official analyses for peanuts, nuts, 31707. corn, oilseeds, and related vegetable (2) USDA, AMS, S&T oils are found in the following manu- c/o Golden Peanut Company, Mail: als: P.O. Box 279, 301 West Pearl Street, (a) Approved Methods of the Amer- Aulander, NC 27805. ican Association of Cereal Chemists
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(AACC), American Association of Ce- 1–AB, 2–AB, 3–AB, and 1–CD is a set real Chemists/Eagan Press, 3340 Pilot cost per pair of analyses and shall be Knob Road, St. Paul, Minnesota 55121– set by cooperative agreement between 2097. the Peanut Administrative Committee (b) ASTA’s Analytical Methods Man- and AMS Science and Technology pro- ual, American Spice Trade Association gram. (ASTA), 560 Sylvan Avenue, P.O. Box 1267, Englewood Cliffs, New Jersey [65 FR 64317, Oct. 26, 2000] 07632. § 93.15 Fees for analytical testing of (c) Analyst’s Instruction for oilseeds. Aflatoxin (August 1994), S&T Instruc- tion No. 1, USDA, Agricultural Mar- The fee charged for any laboratory keting Service, Science and Tech- analysis for oilseeds shall be obtained nology, 3521 South Agriculture Build- from the Laboratory Director for ing, 1400 Independence Avenue, SW., aflatoxin laboratories at the Dothan P.O. Box 96456, Washington, DC 20090– administrative office as listed in 7 CFR 6456. 93.14(a). (d) Official Methods and Rec- [65 FR 64318, Oct. 26, 2000] ommended Practices of the American Oil Chemists’ Society (AOCS), Amer- ican Oil Chemists’ Society, P.O. Box PART 94—POULTRY AND EGG 3489, 2211 West Bradley Avenue, Cham- PRODUCTS paign, Illinois 61821–1827. (e) Official Methods of Analysis of Subpart A—Mandatory Analyses of Egg AOAC INTERNATIONAL, Volumes I & Products II, AOAC INTERNATIONAL, 481 North Sec. Frederick Avenue, Suite 500, Gaithers- 94.1 General. burg, MD 20877–2417. 94.2 Definitions. (f) Standard Analytical Methods of 94.3 Analyses performed and locations of the Member Companies of Corn Indus- laboratories. tries Research Foundation, Corn Refin- 94.4 Analytical methods. ers Association (CRA), 1701 Pennsyl- 94.5 Charges for laboratory service. vania Avenue, NW., Washington, DC 20006. Subpart B—Voluntary Analyses of Egg (g) U.S. Army Natick Research, De- Products velopment and Engineering Center’s 94.100 General. Military Specifications, approved ana- 94.101 Definitions. lytical test methods noted therein, 94.102 Analyses available. Code NPP–9, Department of Defense 94.103 Analytical methods. Single Stock Point (DODSSP) for Mili- 94.104 Fees and charges. tary Specifications, Standards, Build- ing 4/D, 700 Robbins Avenue, Philadel- Subpart C—Salmonella Laboratory phia, PA 19111–5094. Recognition Program [65 FR 64317, Oct. 26, 2000] 94.200 [Reserved]
§ 93.14 Fees for aflatoxin analysis and Subpart D—Processed Poultry Products fees for testing of other mycotoxins. 94.300 General. (a) The fee charged for any labora- 94.301 Definitions. tory analysis for aflatoxins and other 94.302 Analyses available and locations of mycotoxins shall be obtained from the laboratories. Laboratory Director for aflatoxin lab- 94.303 Analytical methods. oratories at the Dothan administrative 94.304 Fees and charges. office as follows: USDA, AMS, Science AUTHORITY: Secs. 2–28 of the Egg Products & Technology, 3119 Wesley Way, Suite Inspection Act (84 Stat. 1620–1635; 21 U.S.C. 6, Dothan, Alabama 36305, Voice Phone: 1031–1056), Agricultural Marketing Act of 334–794–5070, Facsimile: 334–792–1432. 1946, Secs. 202–208 as amended (60 Stat. 1087– (b) The charge for the aflatoxin test- 1091; 7 U.S.C. 1621–1627). ing of raw peanuts under the Peanut SOURCE: 58 FR 42428, Aug. 9, 1993, unless Marketing Agreement for subsamples otherwise noted.
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EDITORIAL NOTE: Nomenclature changes to agency of USDA in 9 CFR 590.580, para- part 94 appear at 61 FR 51352, Oct. 2 1996. graph (d). Official plant. Any plant, as deter- Subpart A—Mandatory Analyses mined by the Secretary, at which the of Egg Products U.S. Department of Agriculture main- tains inspection of the processing of § 94.1 General. egg products under the authority of the Microbiological, chemical, and phys- Egg Products Inspection Act. ical analysis of liquid, frozen, and dried Pasteurize. The subjecting of each egg products is performed under au- particle of egg products to heat or thority of the Egg Products Inspection other treatments to destroy harmful Act (21 U.S.C. 1031–1056). viable microorganisms by such proc- esses as may be prescribed by the regu- § 94.2 Definitions. lations in the EPIA. Words used in the regulations in this Pesticide chemical, food additive, color subpart in the singular form will im- additive, and raw agricultural commodity. port the plural, and vice versa, as the These terms shall have the same mean- case may demand. As used throughout ing for purposes of this subpart as the regulations in this subpart, unless under sections 408, 409, and 706 of the the context requires otherwise, the fol- Federal Food, Drug, and Cosmetic Act. lowing terms will be construed to Plant. Any place of business where mean: egg products are processed. Egg. The shell egg of the domes- Processing. Manufacturing of egg ticated chicken, turkey, duck, goose, products, including breaking eggs or or guinea. Some of the terms applica- filtering, mixing, blending, pasteur- ble to shell eggs are defined by the izing, stabilizing, cooling, freezing, AMS Poultry Programs in 7 CFR 57.5. drying, or packaging egg products at Egg product. Any dried, frozen, or liq- official plants. uid eggs, with or without added ingre- [58 FR 42428, Aug. 9, 1993, as amended at 65 dients. However, products which con- FR 64318, Oct. 26, 2000] tain eggs only in a relatively small proportion or historically have not § 94.3 Analyses performed and loca- been, in the judgment of the Secretary, tions of laboratories. considered by consumers as products of (a) Samples drawn by a USDA egg the egg food industry may be exempted products inspector will be analyzed by by the Secretary under such conditions AMS Science and Technology (S&T) as may be prescribed to assure that the personnel for microbiological, chem- egg ingredients are not adulterated and ical, and physical attributes. The ana- such products are not represented as lytical results of these samples will be egg products. Some of the products ex- reported to the resident egg products empted as not being egg products are inspector at the applicable plant on the specified by the AMS Poultry Pro- official certificate. grams in 7 CFR 57.5. (b) Mandatory egg product samples Mandatory sample. An official sample for Salmonella are required and are ana- of egg product(s) taken for testing lyzed in S&T laboratories to spot check under authority of the Egg Products and confirm the adequacy of USDA ap- Inspection Act (21 U.S.C. 1031–1056) for proved and recognized laboratories for analysis by a United States Depart- analyzing routine egg product samples ment of Agriculture, Agricultural Mar- for Salmonella. keting Service, Science and Tech- (c) Mandatory egg product samples nology laboratory at government ex- for chlorinated hydrocarbons are re- pense. A mandatory sample shall in- quired and are submitted by the plant clude an egg product sample to be ana- inspectors on a random basis. These lyzed for microbiological, chemical, or samples screen for pesticide residues physical attributes. A mandatory egg and industrial chemical contaminants product sample analyzed for the pres- in egg products. ence of Salmonella is also referred to as (d) Samples are drawn by a USDA egg a confirmation sample as specified by products inspector to determine poten- the Food Safety and Inspection Service tial adulteration. These egg product
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samples may be analyzed for extra- (g) Standard Methods for the Exam- neous material, color, color additive, ination of Water and Wastewater, pesticide, heavy metal, microorganism, American Public Health Association dextrin, or other substance. (APHA), the American Water Works (e) The AMS Science and Tech- Association (AWWA) and the Water nology’s Eastern Laboratory shall con- Pollution Control Federation, AWWA duct the majority of laboratory anal- Bookstore, 6666 West Quincy Avenue, yses for egg products. The analyses for Denver, CO 80235. mandatory egg product samples are (h) Test Methods for Evaluating performed at the following USDA loca- tion: USDA, AMS, Science & Tech- Solid Waste Physical/Chemical Meth- nology, Eastern Laboratory (Microbi- ods, Environmental Protection Agency, ology), 2311–B Aberdeen Boulevard, Office of Solid Waste, SW–846 Inte- Gastonia, NC 28054–0614. grated Manual (available from Na- tional Technical Information Service [58 FR 42428, Aug. 9, 1993, as amended at 59 (NTIS), U.S. Department of Commerce, FR 24325, May 10, 1994; 59 FR 50121, Sept. 30, 1994; 65 FR 64318, Oct. 26, 2000] 5285 Port Royal Road, Springfield, VA 22161). § 94.4 Analytical methods. (i) U.S. Food and Drug Administra- The majority of analytical methods tion, Pesticide Analytical Manuals used by the USDA laboratories to per- (PAM), Volumes I and II, Food and form mandatory analyses for egg prod- Drug Administration, Center for Food ucts are listed as follows: Safety and Applied Nutrition (CFSAN), (a) Compendium Methods for the 200 C Street, SW, Washington, DC 20204 Microbiological Examination of Foods, (available from National Technical In- Carl Vanderzant and Don formation Service (NTIS), U.S. Depart- Splittstoesser (Editors), American Pub- ment of Commerce, 5285 Port Royal lic Health Association, 1015 Fifteenth Road, Springfield, VA 22161). Street, NW, Washington, DC 20005. (b) Edwards, P.R. and W.H. Ewing, [65 FR 64318, Oct. 26, 2000] Edwards and Ewing’s Identification of Enterobacteriaceae, Elsevier Science, § 94.5 Charges for laboratory service. Inc., Regional Sales Office, 655 Avenue The costs for analysis of mandatory of the Americas, P.O. Box 945, New egg product samples at Science and York, NY 10159–0945. Technology Division laboratories shall (c) FDA Bacteriological Analytical be paid by annually appropriated and Manual (BAM), AOAC INTER- designated funds allocated to the egg NATIONAL, 481 North Frederick Ave- products inspection program. The costs nue, Suite 500, Gaithersburg, MD 20877– for any other mandatory laboratory 2417. analyses and testing of an egg prod- (d) Manual of Analytical Methods for uct’s identity and condition, neces- the Analysis of Pesticide Residues in sitated by the Egg Products Inspection Human and Environmental Samples, Act, shall also be paid by such program EPA 600/9–80–038, U.S. Environmental funding. Protection Agency (EPA) Chemical Ex- posure Research Branch, EPA Office of Research and Development (ORD), 26 Subpart B—Voluntary Analyses of West Martin Luther King Drive, Cin- Egg Products cinnati, Ohio 45268. (e) Official Methods of Analysis of § 94.100 General. AOAC INTERNATIONAL, Volumes I & Analyses for voluntary egg product II, AOAC INTERNATIONAL, 481 North samples may be requested to certify Frederick Avenue, Suite 500, Gaithers- that specifications regarding stated burg, MD 20877–2417. identity, quality, and wholesomeness (f) Standard Methods for the Exam- are met; to test routinely for the pres- ination of Dairy Products, American ence of Salmonella; and to ensure lab- Public Health Association, 1015 Fif- teenth Street, NW, Washington, DC oratory quality control with testing 20005. activities.
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§ 94.101 Definitions. and minerals, monosodium dihydrogen Words used in the regulations in this phosphate, monosodium glutamate, subpart in the singular form will im- nitrites, oxygen, palatability and odor, port the plural, and vice versa, as the phosphorus, propylene glycol, SLS, and case may demand. As used throughout zeolex. There are also be tests for the regulations in this part, unless the starch, total sugars, sugar profile, context requires otherwise, the fol- whey, standard plate count, direct mi- lowing terms will be construed to croscopic count, Campylobacter, coli- mean: forms, presumptive Escherichia coli, Certification sample. An egg product Listeria monocytogenes, proteolytic sample submitted by an applicant for count, psychrotrophic bacteria, Sal- chemical, physical, or microbiological monella, Staphylococcus, thermoduric analyses and tests at a Science and bacteria, and yeast with mold count. Technology Division laboratory. This voluntary sample is analyzed or tested § 94.103 Analytical methods. by the Division’s analyst or scientist The analytical methods used by the to certify that an egg product lot Science and Technology Division lab- meets applicable specifications for oratories to perform voluntary anal- identity, quality, and wholesomeness. Surveillance sample. This is a 100 gram yses for egg products shall be the same sample for Salmonella analysis that is as listed in § 94.4. drawn by the USDA egg product in- spector from each lot of egg product § 94.104 Fees and charges. processed at an official plant. This (a) The fee charged for any single lab- sample may be analyzed by a Science oratory analysis of voluntary egg prod- and Technology Division laboratory, or uct samples shall be obtained from the by a laboratory approved and recog- schedules of charges in paragraph (a) of nized by the Division to analyze for § 91.37 of this subchapter. Salmonella in egg products. (b) The charge for any requested lab- Unofficial sample. These samples of oratory analysis not listed shall be egg products are drawn by plant per- based on the standard hourly rate spec- sonnel upon the request of plant man- ified in § 91.37, paragraph (b). agement. Analyses of these samples are usually conducted for the plant’s re- fractometer correlation, bacterio- Subpart C—Salmonella Laboratory logical evaluation of production tech- Recognition Program niques, or quality control of proce- dures. Official plant or Science and § 94.200 [Reserved] Technology Division laboratories can analyze these samples. Subpart D—Processed Poultry Products § 94.102 Analyses available. A wide array of analyses for vol- § 94.300 General. untary egg product samples is avail- Laboratory services of processed able. Voluntary egg product samples poultry products are conducted to de- include surveillance, certification, and rive their analytical attributes used to unofficial samples. The physical and determine the compliance of the prod- chemical tests for voluntary egg prod- ucts include analyses for total ash, fat uct with applicable specifications. by acid hydrolysis, moisture, salt, pro- § 94.301 Definitions. tein, beta-carotene, catalase, choles- terol, NEPA color, density, total sol- Words used in the regulations in this ids, aflatoxin, daminozide and amitraz subpart in the singular form will im- residues, BHA, BHT, alcohol, port the plural, and vice versa, as the chlorinated hydrocarbon and fumigant case may demand. As used throughout residues, dextrin, heavy and light filth, the regulations in this subpart, unless glucose, glycerol and gums. In addi- the context requires otherwise, the fol- tion, egg products can be analyzed for lowing terms will be construed to high sucrose content, pH, heavy metals mean:
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Dark meat. Refers to the skinless and Frederick Avenue, Gaithersburg, MD deboned drumstick, thigh, and back 20877–2417. portions of poultry. [61 FR 51352, Oct. 2, 1996] Light meat. Refers to the skinless and deboned breast and wing portions of § 94.304 Fees and charges. poultry. Poultry. Any kind of domesticated (a) The fee charged for any single lab- bird, including, but not limited to, oratory analysis of processed poultry chicken, turkey, duck, goose, pigeon, products shall be obtained from the and guinea. schedules of charges in paragraph (a) of Poultry product. Any ready-to-cook § 91.37 of this subchapter. poultry carcass or part therefrom or (b) The laboratory analyses for proc- any specified poultry food product. essed poultry products shall result in an additional fee, found in Table 7 of § 94.302 Analyses available and loca- § 91.37 of this subchapter, for sample tions of laboratories. preparation or grinding. (a) The Science and Technology Divi- (c) The charge for any requested lab- sion laboratories will analyze proc- oratory analysis of processed poultry essed poultry products for moisture, products not listed shall be based on fat, salt, protein, nitrites, and added the standard hourly rate specified in citric acid. § 91.37 (b) of this subchapter. (b) Deboned poultry for roasting will have the individual dark meat, light PART 95 [RESERVED] meat, and skin portions tumbled sepa- rately in the natural juices prior to PART 96—COTTONSEED SOLD OR grinding. The skin, light meat, and OFFERED FOR SALE FOR CRUSH- dark meat portion weight percentages of the total product are determined. ING PURPOSES (CHEMICAL The ground skin, ground dark meat, ANALYSIS AND UNITED STATES and ground light meat portions will be OFFICIAL GRADE CERTIFI- analyzed separately for moisture, pro- CATION) tein, salt, and fat. Moisture to protein ratios will be reported also for the indi- Subpart A—Cottonseed Chemists— vidual portions of poultry. Licensing Regulations (c) Canned boned poultry for a vari- SCOPE ety of USDA programs will be tested as a total can composite of the canned Sec. product for moisture, fat, salt, and pro- 96.1 General. tein analyses. Additional poultry com- DEFINITIONS modities and related products for spe- cific USDA sponsored programs will be 96.2 Terms defined. tested for different chemical and phys- LICENSED COTTONSEED CHEMISTS ical attributes. (d) Microbiological analyses, as the 96.3 Application for license as cottonseed Salmonella determination, are available chemist; form. 96.4 Examination of applicant. for poultry products. 96.5 Period of license; renewals. (e) The majority of analyses for proc- 96.6 Conditions in licensing. essed poultry products shall be per- 96.7 Sustained proficiency; suspension of li- formed at the Science and technology cense of cottonseed chemist. Division Eastern Laboratory, as indi- 96.8 Annual review of licensed chemist. cated in paragraph (e) of § 94.3. 96.9 Fees for grading and certification. 96.10 Records of analyses; inspection of cer- § 94.303 Analytical methods. tificate recordkeeping. The analytical methods used by the 96.11 Official and unofficial samples; anal- yses; certificate. USDA laboratories to perform analyses 96.12 Unlicensed persons shall not analyze for processed poultry products are and certify the grade of official samples. found in the latest edition of the Offi- 96.13 Grade certificate; form. cial Methods of Analysis of AOAC 96.14 Reports of licensed chemists. INTERNATIONAL, Suite 500, 481 North 96.15 Information of violations.
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96.16 Licensed chemists; suspension or rev- seed is originally mixed in bulk quan- ocation of license. tities at a Division laboratory and 96.17 Revoked license to be returned to Di- packaged so that it is a representative vision. 96.18 Duplicate license. portion for the samples forwarded to 96.19 Information on grading to be kept con- all chemists in a region under a certain fidential. number code. An oil mill representa- tive and official cottonseed sampler re- FEES AND CHARGES package and identify the cottonseed as 96.20 Fee for chemist’s license. an official sample so that it would be 96.21 Fee for certificates to be paid by li- blind or unknown as a check sample to censee to Service. the analyst. 96.22 Fees for the review of grading of cot- Commercial laboratory. A chemical tonseed. laboratory operated by an individual, Subpart B—Official Cottonseed Grade firm, or corporation in which one or Calculations more persons are engaged in the chem- ical analysis of materials for the pub- 96.23 General. lic. 96.24 Definitions, cottonseed quality anal- Cotton gin. The machine or device ysis terms. 96.25 Determination of grade. used to separate the cotton fiber from 96.26 Determination of quantity index. the cottonseed. 96.27 Determination of quality index. Cottonseed. The word ‘‘cottonseed’’ as 96.28 Calculation of grades of official sam- used in this part means the seed, after ples. having been put through the usual and 96.29 Analysis and certification of samples customary process known as cotton and grades. ginning, of any cotton produced within AUTHORITY: 7 U.S.C. 1622, 1624. the continental United States. SOURCE: 58 FR 42431, Aug. 9, 1993, unless Dispute. A disagreement between par- otherwise noted. ties as to the true grade of a sample of cottonseed analyzed and graded by a li- Subpart A—Cottonseed censed chemist. Chemists—Licensing Regulations License. A license issued under the Act by the Secretary. SCOPE Licensed cottonseed chemist. A person licensed under the Act by the Sec- § 96.1 General. retary to make quantitative and quali- Licenses are issued to chemists of tative chemical analyses of official laboratories involved in the grading of samples of cottonseed, according to the cottonseed. A chemist that has passed methods prescribed by the Director of examinations for analyst proficiency the Division, and to certify the grade and for official standards used for grad- according to the official cottonseed ing shall be issued a license to perform standards of the United States. quality analyses for grade determina- Licensed cottonseed sampler. A person tions of cottonseed. licensed by the Secretary to draw and to certify the authenticity of samples DEFINITIONS of cottonseed in accordance with the regulations in this subpart. § 96.2 Terms defined. Lot. That parcel or quantity of cot- Words used in the regulations in this tonseed, offered for sale or tendered for subpart in the singular form will im- delivery, or delivered on a sale or con- port the plural, and vice versa, as the tract of sale, in freight cars, trucks, case may demand. As used throughout wagons, or otherwise in the quantities the regulations in this subpart, unless and within the time limits, prescribed the context requires otherwise, the fol- from time to time by the Director of lowing terms will be construed to the AMS Cotton Division, for the draw- mean: ing and preparation of official samples Blind check sample. A sample des- by licensed cottonseed samplers. ignated to check the routine analytical Official cottonseed standards. The offi- testing performance of the licensed cial standards of the United States for USDA cottonseed chemist. The cotton- the grading, sampling, and analyzing of
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cottonseed sold or offered for sale for any cottonseed oil mill or cotton gin- crushing purposes, established May 23, ning establishment; 1932, and amendments thereto. (4) That the applicant agrees to com- Official sample. A specimen of not less ply with and abide by the terms of the than 2 pounds of cottonseed, drawn and Act and these regulations so far as prepared by a licensed cottonseed sam- they may relate to him or her; pler and certified as representative of a (5) That the applicant is an inde- certain identified lot, in accordance pendent analytical chemist or an em- with the regulations in this subpart. ployee of a commercial analytical lab- Owner. A person who through finan- oratory; and cial interest owns or controls, or has (6) That the applicant owns or will the disposition of either cottonseed or have the use of all of the apparatus of samples of cottonseed. specified in the regulations, estab- Society. The American Oil Chemists’ lished hereunder for the analysis and Society (AOCS), P.O. Box 3489, 1608 grading of cottonseed. Broadmoor Drive, Champaign, IL 61826– (c) Every chemist licensed hereunder 3489. to analyze cottonseed and to certify Supervisor of cottonseed chemists. An the grade thereof shall comply with the officer of the Science and Technology Society’s official analytical test meth- Division designated as such by the Di- ods and other methods of analysis ap- rector. proved by the Director. (d) The applicant shall furnish such [58 FR 42431, Aug. 9, 1993, as amended at 61 additional information, as the Director FR 51352, Oct. 2, 1996] shall at any time find to be necessary, LICENSED COTTONSEED CHEMISTS to the consideration of the submitted application. § 96.3 Application for license as cotton- (e) Upon receipt of an incomplete or seed chemist; form. improperly executed application, the (a) Application for a license to ana- applicant will be notified of the defi- lyze and grade cottonseed shall be ciency in the application. If the appli- made to the Director on a form fur- cation is not corrected and returned nished for the purpose by the Science within 30 days following the date of no- tification, the application will be con- and Technology Division. sidered as having been abandoned. (b) Each application shall be in English, shall be signed by the appli- [58 FR 42431, Aug. 9, 1993, as amended at 61 cant, and shall contain or be accom- FR 51352, Oct. 2, 1996] panied by satisfactory evidence: (1) That the applicant is at least 25 § 96.4 Examination of applicant. years of age and that the applicant is Each applicant for a license as a an actual resident of the continental chemist and each licensed chemist United States; shall, when requested, submit to a (2) That the applicant holds a degree practical examination and written test, in chemistry or chemical engineering to show an ability to analyze and grade from a recognized college or univer- cottonseed. These examinations can sity, and has had not less than 3 years only be administered by the supervisor practical experience in laboratory of cottonseed chemists. The chemist’s work, in which the applicant shall have failure to pass such tests may be con- analyzed quantitatively and quali- sidered sufficient ground for with- tatively samples of cottonseed; or in holding the issuance of a license or of the absence of a degree from a recog- a renewal of a license. nized college or university, that the ap- plicant has had at least 5 years prac- § 96.5 Period of license; renewals. tical laboratory experience, 3 years of The period for which a license may be which shall have been devoted chiefly issued shall be from the first day of Au- to the analysis of samples of cotton- gust, until, and including the 31st day seed; of July, following. Renewals shall be (3) That the applicant has no finan- for not more than 1 year beginning cial interest, or is in the employ of with the first day of August of each anyone having a financial interest in year, provided that licenses issued on
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and after June 1 of any year shall be a 7-day review by the Director for the for the period ending on July 31 of the suspension of his or her license. following year. [58 FR 42431, Aug. 9, 1993, as amended at 61 § 96.6 Conditions in licensing. FR 51352, Oct. 2, 1996] (a) It shall be a condition of the li- § 96.7 Sustained proficiency; suspen- censing of any person and of the reten- sion of license of cottonseed chem- tion by him or her of a license, that ist. during the active cotton season each (a) Sustained proficiency in the anal- year, the licensee shall be engaged in ysis of the two check sample series is or in connection with the grading of required to maintain a license. If a li- cottonseed; that each cottonseed sam- censed chemist fails to perform satis- ple offered for grading shall be ana- factorily during a 1 year period on ei- lyzed and grade certified by the li- ther the AOCS or the USDA check cot- censee, in accordance with the official tonseed series, the chemist shall be cottonseed standards of the United placed on probation for 1 year, pro- States; and that the USDA license of viding that the person achieves a pass- the cottonseed chemist shall not be ing score (90 or higher) on a retake of used or be allowed to be used for any the proficiency examination. In the improper purpose. event that the chemist fails the exam- (b) A USDA licensed cottonseed ination, he or she may be subject to an chemist shall be required to partici- immediate suspension of the license. pate in each quality assurance program (b) Failure to perform satisfactorily and each collaborative study for the with either quality assurance program analytical testing of cottonseed as fol- during a 1 year probationary period lows: may also result in suspension of the li- (1) The licensed chemist must par- cense. ticipate in the American Oil Chemists’ (c) Pending final action by the Direc- Society (AOCS) cottonseed series tor to suspend a license of a cottonseed which requires the testing of 10 known chemist, a written notice of such sus- cottonseed samples per year for foreign pension shall be given to the respective matter, moisture, free fatty acids, oil, and ammonia. licensee, accompanied by a statement of the reasons therefore. Within 7 days (2) The licensed chemist must ana- after receipt of notice and statement of lyze and issue a grade for 10 blind cot- tonseed check samples per year from reasons by a licensee, an appeal may be the Science and Technology Division. filed in writing with the Director sup- These blind check samples will be sub- ported by any argument or evidence as mitted as ‘‘official’’ samples. to why the license should not be sus- (3) The chemist shall participate in pended. After expiration of the 7-day all collaborative cottonseed analytical period and consideration of such argu- method validation studies, initiated by ment and evidence, the Director shall the Division Director. take such action, as deemed appro- (c) Each licensed chemist shall keep priate, with respect to a suspension. his or her license conspicuously posted (d) Upon termination of service as a at the place where he or she functions cottonseed chemist or suspension of as a chemist, or in such other place as such license, such licensee shall sur- may be approved by the Division Direc- render the license immediately to the tor. supervisor of the cottonseed chemists. (d) Each licensed chemist must pay (e) The minimum period of license in a timely manner an annual licensing suspension for a cottonseed chemist renewal fee and other charges and fees shall be 1 year, after which the chemist assessed by the Division, as listed in may reapply and be reexamined for a §§ 96.20 and 96.21. In the event the chem- USDA license. ist fails to pay the annual license re- (f) At the expiration of any period of newal fee by the 31st day of August, the suspension of such license, unless in chemist will be sent a written notice of the meantime it be revoked, the dates
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of the suspension period shall be en- § 96.11 Official and unofficial samples; dorsed thereon and returned to the li- analyses; certificate. censed chemist to whom it was origi- (a) Each licensed cottonseed chemist nally issued. shall designate a certificate number from a series of assigned numbers to § 96.8 Annual review of licensed chem- each official sample of cottonseed as ist. received and shall analyze and certify Each licensed chemist shall be sub- over his or her signature the grade of ject to an annual on-site review, by the each sample or lot of cottonseed in the supervisor of the cottonseed chemists, order of its receipt. to assess the chemist’s continued con- (b) Each such sample which is in formance with procedure and equip- proper condition for analysis under ment requirements of official analyt- these regulations and which is accom- ical test methods. panied by the certificate of a licensed cottonseed sampler certifying it to be § 96.9 Fees for grading and certifi- an official sample that represents an cation. identified lot of cottonseed shall be Whenever any licensed chemist shall considered an official sample. In any grade and/or certify any cottonseed or case where the original sample is lost samples for a fee, the fee charged shall or destroyed before analysis, the dupli- be reasonable, unconditional, non- cate thereof, retained by the licensed discriminatory, and shall be in accord- cottonseed sampler, as provided in ance with a schedule previously sub- § 61.34 of this subchapter, shall become mitted to and approved by the Divi- the official sample. Each licensed sion. The schedule shall include the chemist shall retain for at least 2 certificate fee provided for in § 96.21. weeks a portion of each official sample first analyzed; and in any case where a § 96.10 Records of analyses; inspection review is requested under § 61.8 of this of certificate recordkeeping. subchapter, such retained portion shall (a) Certificate recordkeeping respon- be considered an official sample for sibilities. The laboratory shall have an purposes of review analysis. adequate system for the numbering and (c) Each such sample which is: (1) Not accounting of issued official cottonseed sufficient for proper analysis as an offi- certificates. Provisions shall be made cial sample under these regulations, or for consecutively numbering all cot- (2) Not accompanied by a certificate tonseed grade certificates issued and of a licensed cottonseed sampler, or listing in a separate journal certificate (3) Not believed to be samples of the numbers with the sample identification same seed represented by an official for accurate billing. sample (except duplicates or lost or de- stroyed official samples) shall be con- (b) Retention of records for inspec- sidered an unofficial sample and the li- tion. Each licensed chemist, shall keep, censed cottonseed chemist’s certificate or shall cause to be kept for him or of the grade thereof shall be plainly her, for a period of at least 3 years marked: ‘‘Sample not official; grade after date of analysis, a record of the applies to sample only.’’ This para- analysis of each individual sample of graph shall not apply to mill control or cottonseed graded by the licensee. crush samples. (c) Each licensed chemist shall per- mit any authorized officer or agent of § 96.12 Unlicensed persons shall not the Department to inspect or examine, analyze and certify the grade of of- on any business day during normal ficial samples. business hours, books and records re- (a) No person shall in any way rep- lating to analyses of cottonseed sam- resent that he or she is a chemist li- ples and issuance of cottonseed grade censed under the Act, unless that per- certificates under the Act and the reg- son holds a license issued under the ulations in this subpart. Act. Title 18 U.S.C. 1001, Crimes and
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Criminal Procedures, makes it a crimi- § 96.15 Information of violations. nal offense to knowingly and willfully Whenever any person licensed under make such false representations. this part becomes aware of information (b) Only licensed chemists shall ana- lyze and certify the grade of official relating to the violation of the Act or cottonseed samples. these regulations, such person shall in- form the Director of the Division of the § 96.13 Grade certificate; form. alleged violations. Each grade certificate issued under § 96.16 Licensed chemists; suspension the Act by a licensed chemist shall be or revocation of license. in a form, approved for the purpose by the Director and shall embody within The Director may, without a hearing, its written or printed terms: suspend or revoke the license issued to (a) The caption ‘‘Cottonseed Grade a licensed chemist upon written re- Certificate.’’ quest and a satisfactory statement of (b) The serial number assigned to it. reasons submitted by such licensed (c) The date and place of issuance. chemist. Pending final action by the (d) A statement certifying that the Secretary, the Director may, whenever analysis of the cottonseed sample was such action is deemed necessary, sus- made according to the methods ap- pend or revoke the license of any li- proved by the Director of the Division censed chemist when such licensed and that the grade given is according chemist: to the official standards of the United (a) Has ceased to perform services as States. such chemist; (e) A statement of the condition of (b) Has knowingly or carelessly ana- the lot of cottonseed as reported by the lyzed cottonseed improperly; sampler, and in cases where the sample (c) Has violated or evaded any provi- was submitted by a licensed sampler, sion of the Act or the regulations so far the name and license number of the as they relate to the licensee; sampler. (d) Has used the license or allowed it (f) The identification of each lot of to be used for any fraudulent or im- cottonseed by the marks and notations proper purposes; or by which the seed was identified at the (e) Has in any manner become incom- time the sample was taken, and the or- petent or incapacitated to perform the igin of the cottonseed by county and duties of a licensed chemist. State. (g) All analytical data required by In such cases the Director shall give the Director. written notice of the suspension or rev- (h) The signature and license number ocation to the licensed chemist, ac- of the chemist. In addition, the grade companied by a statement of the rea- certificate may include any other mat- sons therefor. Within 10 days after the ter consistent with the Act or the regu- receipt of the aforesaid notice and lations in this part. Two copies of the statement of reasons by such licensee, grade certificate form shall be sub- the individual may file an appeal, in mitted to and approved by the Divi- writing, with the Secretary, supported sion, before use by a licensed chemist. by any argument or evidence that the A copy of each certificate shall be licensee may wish to offer, as to why mailed to a designated office of the Di- the license should not be suspended or vision within 36 hours after its revoked. After the expiration of the issuance. aforesaid 10-day period and consider- ation of such argument and evidence, § 96.14 Reports of licensed chemists. the Secretary will take such action as Each licensed chemist shall periodi- is deemed appropriate with respect to cally, when requested by the Director, such suspension or revocation. When make reports on forms furnished for no appeal is filed within the prescribed the purpose by the Division, con- 10 days, the license shall be automati- cerning the activities as such licensed cally suspended or revoked. chemist.
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§ 96.17 Revoked license to be returned the grade of cottonseed issued by the to Division. licensee. If a license issued to a licensed chem- (b) Upon receipt of a statement from ist is revoked, such license shall be re- the Service each month, showing the turned to the Division. number of certificates issued by the li- censee, such licensee will forward the § 96.18 Duplicate license. appropriate remittance in the form of a Upon satisfactory proof of the loss or check, draft, or money order payable to destruction of a license issued to a li- the ‘‘Agricultural Marketing Service, censed chemist, a duplicate thereof USDA.’’ may be issued under the same or a new [58 FR 42431, Aug. 9, 1993, as amended at 63 number. FR 16375, Apr. 2, 1998]
§ 96.19 Information on grading to be § 96.22 Fees for the review of grading kept confidential. of cottonseed. Every person licensed under the Act For the review of the grading of any as a licensed chemist shall keep con- lot of cottonseed, the fee shall be fidential all information secured by the $60.00. Remittance to cover such fee, in licensee, relative to cottonseed ana- the form of a check, draft, or money lyzed and graded by the licensee. The order payable to the ‘‘Agricultural licensee shall not disclose such infor- Marketing Service, USDA’’ shall ac- mation to any person, except to the company each application for review. owner or custodian of the seed in ques- For each such fee collected, $20.00 shall tion, or to an authorized agent of the be disbursed to each of the two licensed Department. chemists designated to make reanaly- sis of such seed. FEES AND CHARGES § 96.20 Fee for chemist’s license. Subpart B—Official Cottonseed (a) The fee for the examination of an Grade Calculations applicant for a license as a chemist to analyze and certify the grade of cotton- § 96.23 General. seed shall be $1,166.00. Using methods prescribed by the (b) The examination fee shall be paid Science and Technology Division, the at the time the application is filed or licensed cottonseed chemist makes at a time prior to the administration of quantitative and qualitative chemical the examinations. This fee shall be analyses, certificating the grade ac- paid regardless of the outcome of the cording to the official cottonseed licensing examinations. The examina- standards of the United States. tion fee shall be nonrefundable to the applicant; however, in the event of § 96.24 Definitions, cottonseed quality death of the applicant prior to the ex- analysis terms. amination, full payment of the fee may Words used in the regulations in this be returned to the applicant’s bene- subpart in the singular form will im- ficiary. If an application is filed with port the plural, and vice versa, as the an insufficient fee, the application and case may demand. As used throughout fee submitted will be returned to the the regulations in this subpart, unless applicant. the context requires otherwise, the fol- (c) For each renewal of a chemist’s li- lowing terms will be construed to cense, the fee shall be $292.00. mean: [63 FR 16375, Apr. 2, 1998] Cottonseed quality analysis. In deter- mining the quality of cottonseed, test- § 96.21 Fee for certificates to be paid ing is performed by licensed chemists by licensee to Service. for total composition of oil, ammonia, (a) To cover the cost of administering moisture, free fatty acids, and foreign the regulations in this part, each li- matter. These individual analytical censed cottonseed chemist shall pay to factors of cottonseed samples are com- the Service $3.18 for each certificate of bined to form indexes of quantity and
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quality, which in turn are used to de- (b) For American Pima cottonseed, termine the official grade of cotton- the quantity index shall equal four seed, in accordance with the United times the percentage of oil, plus six States Official Standards for Grades. times the percentage of ammonia, Foreign matter. The foreign matter in minus ten. cottonseed includes boll portions, sand, dirt, stones or gravel, hulls, leaves, § 96.27 Determination of quality index. stems, unginned locks of cotton, lint The quality index of cottonseed shall cotton, immature seeds, and any non- be an index of purity and soundness, cotton extraneous material. and shall be determined as follows: Official grade. The official grade is (a) Prime quality cottonseed. Cotton- the product of the quantity index times seed, that by analysis, contains not the quality index, and it is determined more than 1.0 percent of foreign mat- by a representative official sample of ter, not more than 12.0 percent of mois- cottonseed, graded by a licensed chem- ture, and not more than 1.8 percent of ist under the supervision of the United free fatty acids in the oil in the seed, States Department of Agriculture. The shall be known as prime quality cot- base grade for cottonseed is 100.0. tonseed and shall have a quality index Quality index. The quality index of 100. measures the deterioration of cotton- (b) Below prime quality cottonseed. The seed in oil and meal and takes into ac- quality index of cottonseed that, by count the excesses of moisture, foreign analysis, contains foreign matter, matter and free fatty acids. moisture, or free fatty acids in the oil Quantity index. The quantity index in the seed, in excess of the percent- measures the oil and cake or meal in ages prescribed in paragraph (a) of this the cottonseed and takes into account section, shall be found by reducing the variations in the quantity of oil and quality index of prime quality cotton- ammonia. seed as follows: (1) Four-tenths of a unit for each 0.1 § 96.25 Determination of grade. percent of free fatty acids in the oil, in the seed, in excess of 1.8 percent. The grade of cottonseed shall be de- (2) One-tenth of a unit for each 0.1 termined from the analysis of samples, percent of foreign matter in excess of and it shall be the result, stated in the 1.0 percent. nearest whole or half numbers, ob- (3) One-tenth of a unit for each 0.1 tained by multiplying a quantity index percent of moisture in excess of 12.0 by a quality index and dividing the re- percent. sult by 100. The quantity index and the (c) Off quality cottonseed. Cottonseed quality index shall be determined as that has been treated by either me- hereinafter provided. chanical or chemical process other (a) The basis grade of cottonseed than the usual cleaning, drying, and shall be grade 100. ginning (except sterilization required (b) High grades of cottonseed shall be by the United States Department of those grades above 100. Agriculture for quarantine purposes) or (c) Low grades of cottonseed shall be that are fermented or hot, or that upon those grades below 100. analysis are found to contain 12.5 per- (d) Grades for American Pima cotton- cent or more of free fatty acids, in the seed shall be suffixed by the designa- oil, in the seed, or more than 10.0 per- tion ‘‘American Pima’’ or by the sym- cent of foreign matter, or more than bol ‘‘AP.’’ 20.0 percent of moisture, or more than 25.0 percent of moisture and foreign § 96.26 Determination of quantity matter combined, shall be designated index. as ‘‘off quality cottonseed.’’ The quantity index of cottonseed (d) Below grade cottonseed. Cotton- shall be determined as follows: seed, the grade of which, when cal- (a) For Upland cottonseed, the quan- culated according to § 96.25 is below tity index shall equal four times the grade 40.0, shall be designated as percentage of oil, plus six times the ‘‘below grade cottonseed,’’ and a nu- percentage of ammonia, plus five. merical grade shall not be indicated.
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§ 96.28 Calculation of grades of official 97.10 Parts of an application to be filed to- samples. gether. 97.11 Application accepted and filed when (a) Data on certificates of official received. cottonseed analyses shall be expressed 97.12 Number and filing date of an applica- as follows: tion. Foreign Matter to—0.1 percent 97.13 When the owner is deceased or legally Oil to—0.1 percent incapacitated. Ammonia to—0.01 percent 97.14 Joint applicants. Free Fatty Acid, when 5% or under, to—0.1 97.15 Assigned varieties and certificates. percent 97.16 Amendment by applicant. Free Fatty Acid, when over 5%, to—0.5 per- 97.17 Papers of completed application to be cent retained. 97.18 Applications handled in confidence. Quantity Index to—0.01 percent 97.19 Publication of pending applications. Quality Index to—0.1 percent 97.20 Abandonment for failure to respond (b) Grade to whole or half units, within the time limit. whichever actual calculation is nearest 97.21 Extension of time for a reply. shall be determined as follows: 97.22 Revival of an application abandoned (1) The calculation of grades shall be for failure to reply. made by the method of disregarding 97.23 Voluntary withdrawal and abandon- the figures to the right of the second ment of an application. decimal place. 97.24 Assignee. (2) Calculated grades ending with EXAMINATIONS, ALLOWANCES, AND DENIALS .2500 through .7499 will be considered to 97.100 Examination of applications. be in the .25 through .74 range, and will 97.101 Notice of allowance. be reported to the nearest half grade. 97.102 Amendments after allowance. (3) Calculated grades ending with 97.103 Issuance of a certificate. .7500 through .2499 will be considered to 97.104 Application or certificate abandoned. be in the .75 through .24 range, and will 97.105 Denial of an application. be reported to the nearest whole grade. 97.106 Reply by applicant; request for recon- sideration. § 96.29 Analysis and certification of 97.107 Reconsideration and final action. samples and grades. 97.108 Amendments after final action. The certification of samples of cot- CORRECTION OF ERRORS IN CERTIFICATE tonseed, and the analysis and certifi- 97.120 Corrected certificate—office mistake. cation of grades of cottonseed shall be 97.121 Corrected certificate—applicant’s performed in accordance with methods, mistake. approved from time to time for the purposes by the Director, or a des- REISSUANCE OF CERTIFICATE ignated representative. 97.122 Certified seed only election.
ASSIGNMENTS AND RECORDING PART 97—PLANT VARIETY AND 97.130 Recording of assignments. PROTECTION 97.131 Conditional assignments. 97.132 Assignment records open to public in- SCOPE spection.
Sec. MARKING OR LABELING PROVISIONS 97.1 General. 97.140 After filing. DEFINITIONS 97.141 After issuance. 97.142 For testing or increase. 97.2 Meaning of words. 97.143 Certified seed only. ADMINISTRATION 97.144 Additional marking or labeling. 97.3 Plant Variety Protection Board. ATTORNEYS AND AGENTS 97.150 Right to be represented. THE APPLICATION 97.151 Authorization. 97.5 General requirements. 97.152 Revocation of authorization; with- 97.6 Application for certificate. drawal. 97.7 [Reserved] 97.153 Persons recognized. 97.8 Specimen requirements. 97.154 Government employees. 97.9 Drawings and photographs. 97.155 Signatures.
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97.156 Addresses. PUBLIC USE DECLARATION 97.157 Professional conduct. 97.700 Public interest in wide usage. 97.158 Advertising. PUBLICATION FEES AND CHARGES 97.800 Publication of public variety descrip- 97.175 Fees and charges. tions. 97.176 Fees payable in advance. 97.900 Form of official identification sym- 97.177 Method of payment. bol. 97.178 Refunds. 97.179 Copies and certified copies. AUTHORITY: Plant Variety Protection Act, as amended, 7 U.S.C. 2321 et seq.; and Sec. 14, AVAILABILITY OF OFFICE RECORDS Plant Variety Protection Act amendments of 97.190 When open records are available. 1994, 7 U.S.C. 2401 note. SOURCE: 58 FR 42435, Aug. 9, 1993, unless PROTEST PROCEEDINGS otherwise noted. 97.200 Protests to the grant of a certificate. 97.201 Protest proceedings. SCOPE
PRIORITY CONTEST § 97.1 General. 97.205 Definition; when declared. Certificates of protection are issued 97.206 Preparation for priority contest be- by the Plant Variety Protection office tween applicants. for new, distinct, uniform, and stable 97.207 Preparation of priority papers and varieties of sexually reproduced or declaration of priority contest. tubor propagated plants. Each certifi- 97.208 Burden of proof. cate of plant variety protection cer- 97.209 Preliminary statement on novel vari- ety developed in the United States. tifies that the breeder has the right, 97.210 Preliminary statement on novel vari- during the term of the protection, to ety developed in a foreign country. prevent others from selling the variety, 97.211 Statements sealed before filing. offering it for sale, reproducing it, im- 97.212 Correction of a statement on motion. porting or exporting it, conditioning it, 97.213 Failure to file statements. stocking it, or using it in producing a 97.214 Access to preliminary statements. hybrid or different variety from it, as 97.215 Dissolution at the request of the provided by the Act. Commissioner. 97.216 Concession; abandonment. [58 FR 42435, Aug. 9, 1993, as amended at 60 97.217 Affidavits and exhibits. FR 17189, Apr. 4, 1995] 97.218 Matters considered in determining a priority. DEFINITIONS 97.219 Recommendation by the Commis- sioner. § 97.2 Meaning of words. 97.220 Decision by the Commissioner. Words used in the regulations in this 97.221 Status of claims of defeated appli- cant. part in the singular form will import 97.222 Second priority contest. the plural, and vice versa, as the case may demand. The definitions of terms APPEAL TO THE SECRETARY contained in the Act shall apply to 97.300 Petition to the Secretary. such terms when used in this part. As 97.301 Commissioner’s answer. used throughout the regulations in this 97.302 Decision by the Secretary. part, unless the context requires other- 97.303 Action following the decision. wise, the following terms will be con-
GENERAL PROCEDURES IN PRIORITY, PROTEST, strued to mean: OR APPEAL PROCEEDINGS Abandoned application. An application which has not been pursued to comple- 97.400 Extensions of time. tion within the time allowed by the Of- 97.401 Miscellaneous provisions. 97.402 Service of papers. fice or has been voluntarily abandoned. 97.403 Manner of service. Act. The Plant Variety Protection Act (7 U.S.C. 2321 et seq.). REVIEW OF DECISIONS BY COURT Administrator. The Administrator of 97.500 Appeal to U.S. Courts. the Agricultural Marketing Service of the U.S. Department of Agriculture, or CEASE AND DESIST PROCEEDINGS any other officer or employee of the 97.600 Rules of practice. Department of Agriculture to whom
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authority has heretofore been dele- rights to such variety have been as- gated, or to whom authority may here- signed or transferred. after be delegated, to act in his or her Person. An individual, partnership, stead. corporation, association, government Applicant. The person who applied for agency, or other business or govern- a certificate of plant variety protec- mental entity. tion. Secretary. The Secretary of Agri- Application. An application for plant culture of the United States or any variety protection under the Act. other officer or employee of the U.S. Assignee. A person to whom an owner Department of Agriculture, to whom assigns his/her rights in whole or in authority has heretofore been dele- part. gated, or to whom authority may here- Board. The Plant Variety Protection after be delegated to act in his or her Board appointed by the Secretary. stead. Certificate. A certificate of plant vari- Seed certifying agency. It shall be de- ety protection issued under the Act by fined as set forth in the Federal Seed the Office. Act (53 Stat. 1275). Sale for other than seed purposes. The Certified seed. Seed which has been de- transfer of title to and possession of termined by an official seed certifying the seed by the owner to a grower or agency to conform to standards of ge- other person, for reproduction for the netic purity and identity as to variety, owner, for testing, or for experimental which standards have been approved by use, and not for commercial sale of the the Secretary. seed or the reproduced seed for plant- The Examiner in Chief Commissioner. ing purposes. of the Office. Decision and order. Includes the Sec- [58 FR 42435, Aug. 9, 1993, as amended at 60 retary’s findings of fact; conclusions FR 17189, Apr. 4, 1995; 61 FR 248, Jan. 4, 1996] with respect to all material issues of ADMINISTRATION fact and law, as well as the reasons or basis therefor; and order. § 97.3 Plant Variety Protection Board. Examiner. An employee of the Plant (a) The Plant Variety Protection Variety Protection Office who deter- Board shall consist of 14 members ap- mines whether a certificate is entitled pointed for a 2-year term. The Board to be issued. The term shall, in all shall be appointed every 2 years and cases, include the Commissioner. shall consist of individuals who are ex- Foreign application. An application perts in various areas of varietal devel- for plant variety protection filed in a opment. The membership of the Board, foreign country. which shall include farmer representa- Hearing Clerk. The Hearing Clerk, tion, shall be drawn approximately U.S. Department of Agriculture, Wash- equally from the private or seed indus- ington, DC. try sector and from the government or Hearing Officer. An Administrative public sector. No member shall be eli- Law Judge, U.S. Department of Agri- gible to act on any matter involving culture, or other officer or employee of any appeal or questions under section the Department of Agriculture, duly 44 of the Act, in which the member or assigned to preside at a hearing held his or her employer has a direct finan- pursuant to the rules of this part. cial interest. Office or Plant Variety Protection Of- (b) The functions of the Board are to: fice. The Plant Variety Protection Of- (1) Advise the Secretary concerning fice, Science and Technology Division, adoption of rules and regulations to fa- AMS, USDA. cilitate the proper administration of Official Journal. The ‘‘Official Journal the Act; of the Plant Variety Protection Of- (2) Make advisory decisions on all ap- fice.’’ peals from the examiner or Commis- Owner. A breeder who developed or sioner; discovered a variety for which plant (3) Advise the Secretary on the dec- variety protection may be applied for laration of a protected variety open to under the Act, or a person to whom the use in the public interest; and
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(4) Advise the Secretary on any other seed, need not be completed at the time matters under the regulations in this of application. part. (2) A completed set of the exhibits, as (c) The proceedings of the Board shall specified in the application form, un- be conducted in accordance with the less the examiner waives submission of Federal Advisory Committee Act, Ad- certain exhibits as unnecessary, based ministrative Regulations of the U.S. on other claims and evidence presented Department of Agriculture (7 CFR part in connection with the application. 25), and such additional operating pro- (3) Language and legibility: (i) Appli- cedures as are adopted by members of cations and exhibits must be in the the Board. English language and legibly written, [58 FR 42435, Aug. 9, 1993, as amended at 61 typed or printed. FR 248, Jan. 4, 1996] (ii) Any interlineation, erasure, can- cellation, or other alteration must be THE APPLICATION made in permanent ink before the ap- plication is signed and shall be clearly § 97.5 General requirements. initialed and dated by the applicant to (a) Protection under the Act shall be indicate knowledge of such fact at the afforded only as follows: time of signing. (1) Nationals and residents of the (4) To determine the extent of reci- United States shall be eligible to re- procity of the protection to be provided ceive all of the protection under the under the Act, persons filing an appli- Act. cation for plant variety protection in (2) Nationals and residents of Mem- the United States under the provisions ber States of the International Union of paragraph (a)(3) of this section shall, for the Protection of New Varieties of upon request 1, furnish the Plant Vari- Plants (including states which are ety Protection Office with a copy of members of an intergovernmental or- the current plant variety protection ganization which is a UPOV member) laws and regulations for the country of shall be eligible to receive the same which the applicant is a national, and protection under the Act as is provided an accurate English translation of such to nationals of the United States. laws and regulations. (3) Persons who are not entitled to (c) Application and exhibit forms protection under paragraph (a)(1) or (2) shall be issued by the Commissioner. of this section, and who are nationals (Copies of the forms may be obtained of a foreign state which is not a mem- from the Plant Variety Protection Of- ber of the International Union for the fice, Science and Technology Division, Protection of New Varieties of Plants, AMS, USDA, room 500, National Agri- shall be entitled to only so much of the cultural Library Building, Beltsville, protection provided under the Act, as Maryland 20705.) is afforded by such foreign state to na- (d) Effective the date of these regula- tionals of the United States, for the tions and rules of practice, the signa- same genus and species under the laws ture of the applicant, or his or her of such foreign state in effect at the agent or attorney on any affidavit or time that the application for protec- other statement filed pursuant to these tion under the Act is filed, except regulations and rules constitutes a cer- where further protection under the Act tification by the applicant. The signa- must be provided in order to avoid the ture certifies that all information re- violation of a treaty to which the lied on in any affidavit or statement United States is a party. filed in the course of the proceeding is (b) Applications for certificates shall be made to the Plant Variety Protec- tion Office. An application shall con- 1 Copies and translations of foreign laws sist of: and regulations will be requested only if they are not in the files of the Plant Variety (1) A completed application form, ex- Protection Office. Applicants may learn cept that the section specifying that whether such a request will be made by writ- seed of the variety shall be sold by va- ing to the address given in paragraph (c) of riety name only, as a class of certified this section.
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knowingly correct and false claims cluding travel, per diem or subsistence, have not been made to mislead. and salary. (b) Plant specimens submitted in sup- [58 FR 42435, Aug. 9, 1993, as amended at 60 FR 17189, Apr. 4, 1995; 61 FR 248, Jan. 4, 1996] port of an application shall not be re- moved from the Office except by an § 97.6 Application for certificate. employee of the Office or other person authorized by the Secretary. (a) An application for a plant variety (c) Plant specimens submitted to the protection certificate shall be signed Office shall, except as provided below, by, or on behalf, of the applicant. and upon request, be returned to the (b) The application shall state the applicant at his or her expense after full name, including the full first name the specimens have served their in- and the middle initial or name, if any, tended purpose. The Commissioner, and the capacity of the person exe- upon a finding of good cause, may re- cuting it. quire that certain specimens be re- (c) The fees for filing an application, tained in the Office for indefinite peri- and search or examination, shall be ods of time. Specimens which are not submitted with the application in ac- returned or not retained as provided cordance with §§ 97.175 through 97.178. above shall be destroyed. (d) The applicant shall submit with the application: § 97.9 Drawings and photographs. (1) At least 2,500 seeds of the viable (a) Drawings or photographs sub- basic seed required to reproduce the va- mitted with an application shall dis- riety; close the distinctive characteristics of (2) With the application for a tuber the variety. propagated variety, verification that a (b) Drawings or photographs shall be viable cell culture has been deposited in color when color is a distinguishing in a public depository approved by the characteristic of the variety, and the Commissioner and will be maintained color shall be described by use of Nick- for the duration of the certificate; or erson’s or other recognized color chart. (3) With the application for a hybrid (c) Drawings should be sent flat, or from self-incompatible parents, may be sent in a suitable mailing tube, verification that a plot of vegetative in accordance with instructions fur- material for each parent has been es- nished by the Commissioner. tablished in a public depository ap- (d) Drawings or photographs sub- proved by the Commissioner and will mitted with an application shall be re- be maintained for the duration of the tained by the Office as part of the ap- certificate. plication file. [58 FR 42435, Aug. 9, 1993, as amended at 60 FR 17189, Apr. 4, 1995; 61 FR 248, Jan. 4, 1996] § 97.10 Parts of an application to be filed together. § 97.7 [Reserved] All parts of an application, including exhibits, should be submitted to the Of- § 97.8 Specimen requirements. fice together, otherwise, each part (a) The applicant may be required by shall be accurately and clearly ref- the examiner to furnish representative erenced to the application. specimens of the variety, or its flower, fruit, or seeds, in a quantity and at a § 97.11 Application accepted and filed specified stage of growth, as may be when received. necessary to verify the statements in (a) An application, if materially com- the application. Such specimens shall plete when initially submitted, shall be be packed and forwarded in conformity accepted and filed to await examina- with instructions furnished by the ex- tion. aminer. If the applicant requests the (b) If any part of an application is so examiner to inspect plants in the field incomplete, or so defective that it can- before a final decision is made, all such not be handled as a completed applica- inspection costs shall be borne by the tion for examination, as determined by applicant by payment of fees sufficient the Commissioner, the applicant will to reimburse the Office for all costs, in- be notified. The application will be
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held a maximum of 3 months for com- by filing a corrected application, to- pletion. Applications not completed at gether with a written explanation, the end of the prescribed period will be signed by all of the joint owners. Such considered abandoned. The application statement shall also be signed by the fee in such cases will not be refunded. assignee, if any. [58 FR 42435, Aug. 9, 1993, as amended at 60 (d) If a joint owner refuses to join in FR 17189, Apr. 4, 1995] an application or cannot be found after diligent effort, the remaining owner § 97.12 Number and filing date of an may file an application on behalf of application. him or herself and the missing owner. (a) Applications shall be numbered Such application shall be accompanied and dated in sequence in the order re- by a written explanation and shall ceived in the Office. Applicants will be state the last known address of the informed in writing as soon as prac- missing owner. Notice of the filing of ticable of the number and effective fil- the application shall be forwarded by ing date of the application. the Office to the missing owner at the (b) An applicant may claim the ben- last known address. If such notice is re- efit of the filing date of a prior foreign turned to the Office undelivered, or if application in accordance with section the address of the missing owner is un- 55 of the Act. A certified copy of the known, notice of the filing of the appli- foreign application shall be filed upon cation shall be published once in the request made by the examiner. If a for- Official Journal. Prior to the issuance eign application is not in the English of the certificate, a missing owner may language, an English translation, cer- join in an application by filing a writ- tified as accurate by a sworn or official translator, shall be submitted with the ten explanation. A certificate obtained application. by less than all of the joint owners under this paragraph conveys the same § 97.13 When the owner is deceased or rights and privileges to said owners as legally incapacitated. though all of the original owners had In case of the death of the owner or joined in an application. if the owner is legally incapacitated, the legal representative (executor, ad- § 97.15 Assigned varieties and certifi- ministrator, or guardian) or heir or as- cates. signee of the deceased owner may sign In case the whole or a part interest as the applicant. If an applicant dies in a variety is assigned, the application between the filing of his or her applica- shall be made by the owner or one of tion and the granting of a certificate the persons identified in § 97.13. How- thereon, the certificate may be issued ever, the certificate may be issued to to the legal representative, heir, or as- the assignee, or jointly to the owner signee, upon proper intervention. and the assignee, when a part interest in a variety is assigned. § 97.14 Joint applicants. (a) Joint owners shall file a joint ap- [58 FR 42435, Aug. 9, 1993, as amended at 60 FR 17189, Apr. 4, 1995] plication by signing as joint appli- cants. § 97.16 Amendment by applicant. (b) If an application for certificate is made by two or more persons as joint An application may be amended be- owners, when they were not in fact fore or after the first examination and joint owners, the application shall be action by the Office, after the second amended prior to issuance of a certifi- or subsequent examination or reconsid- cate by filing a corrected application, eration as specified in § 97.107, or when together with a written explanation and as specifically required by the ex- signed by the original applicants. Such aminer. Such amendment may include statement shall also be signed by the a specification that seed of the variety assignee, if any. be sold by variety name only as a class (c) If an application has been made of certified seed, if not previously spec- by less than all the actual joint own- ified or if previously declined. Once an ers, the application shall be amended affirmative specification is made, no
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amendment to reverse such a specifica- directly or through the attorney or tion will be permitted unless the vari- agent of record, and a time, not less ety has not been sold and labeled or than 30 days, shall be set for presenting publication made in any manner that objections. the variety is to be sold by variety name, only as a class of certified seed. § 97.19 Publication of pending applica- tions. § 97.17 Papers of completed applica- Information relating to pending ap- tion to be retained. plications shall be published in the Of- The papers submitted with a com- ficial Journal periodically as deter- pleted application shall be retained by mined by the Commissioner to be nec- the Office except as provided in essary in the public interest. With re- § 97.23(c). After issuance of a certificate spect to each application, the Official of protection the Office will furnish Journal shall show: copies of the application and related (a) Application number and date of papers to any person upon payment of filing; the specified fee. (b) The name of the variety or tem- porary designation; § 97.18 Applications handled in con- (c) The name of the kind of seed; and fidence. (d) Whether the applicant specified (a) Pending applications shall be han- that the variety is to be sold by variety dled in confidence. Except as provided name only as a class of certified seed, below, no information may be given by together with a limitation in the num- the Office respecting the filing of an ber of generations that it can be cer- application, the pendency of any par- tified. ticular application, or the subject mat- Additional information, such as the ter of any particular application. Also, name and address of the applicant or a nor will access be given to or copies brief description of the distinctive fea- furnished of any pending application or tures of the variety, may be published papers relating thereto, without writ- only upon request or approval received ten authority of the applicant, or his from the applicant, at the time the ap- or her assignee or attorney or agent. plication is filed or at any time before Exceptions to the above may be made the notice of allowance of a certificate by the Commissioner in accordance is issued. with 5 U.S.C. 552 and § 1.4 of this title, and upon a finding that such action is [58 FR 42435, Aug. 9, 1993, as amended at 60 necessary to the proper conduct of the FR 17189, Apr. 4, 1995; 61 FR 248, Jan. 4, 1996] affairs of the Office, or to carry out the provisions of any Act of Congress, or as § 97.20 Abandonment for failure to re- provided in sections 56 or 57 of the Act spond within the time limit. and § 97.19. (a) Except as otherwise provided in (b) Abandoned applications shall not § 97.104, if an applicant fails to advance be open to public inspection. However, actively his or her application within if an abandoned application is directly 30 days after the date when the last re- referred to in an issued certificate and quest for action was mailed to the ap- is available, it may be inspected or plicant by the Office, or within such copies obtained by any person on writ- longer time as may be fixed by the ten request, and with written authority Commissioner, the application shall be received from the applicant. Aban- deemed abandoned. The application fee doned applications shall not be re- in such cases will not be refunded. turned. (b) The submission of an amendment (c) Decisions of the Commissioner on to the application, not responsive to abandoned applications not otherwise the last request by the Office for ac- open to public inspection (see para- tion, and any proceedings relative graph (b) of this section) may be pub- thereto, shall not operate to save the lished or made available for publica- application from abandonment. tion at the Commissioner’s discretion. (c) When the applicant makes a bona When it is proposed to release such a fide attempt to advance the applica- decision, the applicant shall be notified tion, and is in substantial compliance
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with the request for action, but has in- by the payment of the prescribed fee advertently failed to comply with some and a showing that the abandonment procedural requirement, opportunity to occurred without fraudulent intent. comply with the procedural require- (c) An original application which has ment shall be given to the applicant been voluntarily withdrawn shall be re- before the application shall be deemed turned to the applicant and may be re- abandoned. The Commissioner may set considered only by refiling and pay- a period, not less than 30 days, to cor- ment of a new application fee. rect any deficiency in the application. (d) Transitional provision. An appli- [58 FR 42435, Aug. 9, 1993, as amended at 60 cant whose application is pending on FR 17189, Apr. 4, 1995] April 4, 1995, may notify the Plant Va- riety Protection Office in writing that § 97.21 Extension of time for a reply. he or she wishes to withdraw the appli- The time for reply by an applicant to cation and refile it under the Plant Va- a request by the Office for certain ac- riety Protection Act as amended in tion, shall be extended by the Commis- 1994. Payment of the current applica- sioner only for good and sufficient tion fee is required but no other for- cause, and for a specified reasonable malities are necessary. time. A request for extension and ap- propriate fee shall be filed on or before [58 FR 42435, Aug. 9, 1993, as amended at 60 the specified time for reply. In no case FR 17189, Apr. 4, 1995] shall the mere filing of a request for § 97.24 Assignee. extension require the granting of an extension or state the time for reply. The assignee of record of the entire interest in an application is entitled to [58 FR 42435, Aug. 9, 1993, as amended at 61 FR 248, Jan. 4, 1996] advance actively or abandon the appli- cation to the exclusion of the appli- § 97.22 Revival of an application aban- cant. doned for failure to reply. EXAMINATIONS, ALLOWANCES, AND An application abandoned for failure DENIALS on the part of the applicant to advance actively his or her application to its § 97.100 Examination of applications. completion, in accordance with the regulations in this part, may be re- (a) [Reserved] vived as a pending application within 3 (b) Examinations of applications months of such abandonment, upon a shall include a review of all available finding by the Commissioner that the documents, publications, or other ma- failure was inadvertent or unavoidable terial relating to varieties of the spe- and without fraudulent intent. A re- cies involved in the application, except quest to revive an abandoned applica- that if there are fundamental defects in tion shall be accompanied by a written the application, as determined by the statement showing the cause of the examiner, the examination may be lim- failure to respond, a response to the ited to an identification of such defects last request for action, and by the spec- and notification to the applicant of ified fee. needed corrective action. However, matters of form or procedure need not, § 97.23 Voluntary withdrawal and but may, be raised by an examiner abandonment of an application. until a variety is found to be new, dis- (a) An application may be volun- tinct, uniform, and stable and entitled tarily withdrawn or abandoned by sub- to protection. mitting to the Office a written request for withdrawal or abandonment, signed [58 FR 42435, Aug. 9, 1993, as amended at 60 by the applicant or his or her attorney FR 17189, Apr. 4, 1995] or agent of record, if any, or the as- signee of record, if any. § 97.101 Notice of allowance. (b) An application which has been If, on examination, it shall appear voluntarily abandoned may be revived that the applicant is entitled to a cer- within 3 months of such abandonment tificate, a notice of allowance shall be
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sent to the applicant or his or her at- (c) If the allowance fee, the viable torney or agent of record, if any, call- basic seed sample or the fee for delayed ing for the payment of the prescribed payment are submitted within 9 fee, which fee shall be paid within 1 months of the final due date, it may be month from the date of the notice of accepted by the Commissioner as allowance. Thereafter, a fee for delayed though no abandonment had occurred. payment shall be made as required For good cause, the Commissioner may under § 97.175. extend for a reasonable time the period for submitting a viable basic seed sam- § 97.102 Amendments after allowance. ple before declaring the certificate Amendments to the application, after abandoned. the notice of allowance is issued, may (d) A certificate may be voluntarily be made, if the certificate has not been abandoned by the applicant or his or issued. her attorney or agent of record or the assignee of record by notifying the § 97.103 Issuance of a certificate. Commissioner in writing. Upon receipt (a) After the notice of allowance has of such notice, the Commissioner shall been issued, the prescribed fee is re- publish a notice in the Official Journal ceived by the Office, and the applicant that the variety has become open for has clearly specified whether or not the use by the public, and if previously variety shall be sold by variety name specified to be sold by variety name as only as a class of certified seed, the ‘‘certified seed only,’’ that such restric- certificate shall be promptly issued. tion no longer applies. Once an election is made and a certifi- cate issued specifying that seed of the [58 FR 42435, Aug. 9, 1993, as amended at 60 variety shall be sold by variety name FR 17189, Apr. 4, 1995] only as a class of certified seed, no waiver of such rights shall be per- § 97.105 Denial of an application. mitted by amendment of the certifi- (a) If the variety is found by the ex- cate. aminer to be not new, distinct, uni- (b) The certificate shall be delivered form, and stable, the application shall or mailed to the owner. be denied. § 97.104 Application or certificate (b) In denying an application, the ex- abandoned. aminer shall cite the reasons the appli- cation was denied. When a reason in- (a) Except as provided in paragraph volves the citation of certain material (c) of this section, if the fee specified in which is complex, the particular part the notice of allowance is not paid of the material relied on shall be des- within 1 month from the date of the ignated as nearly as practicable. The notice, the application shall be consid- ered abandoned. pertinence of each reason, if not obvi- (b) Upon request by the Office, the ous, shall be clearly explained. owner shall replenish the viable basic (c) If prior domestic certificates are seed sample of the variety. Upon re- cited as a reason for denial, their num- quest, the sample of seed which has bers and dates and the names of the been replaced shall be returned to the owners shall be stated. If prior foreign owner, otherwise it shall be destroyed. certificates or rights are cited, as a Failure to replenish viable basic seed reason for denial, their nationality or within 3 months from the date of re- country, numbers and dates, and the quest shall result in the certificate names of the owners shall be stated, being regarded as abandoned. No soon- and such other data shall be furnished, er than 1 year after the date of such re- as may be necessary to enable the ap- quest, notices of abandoned certificates plicant to identify the cited certifi- shall be published in the Official Jour- cates or rights. nal, indicating that the variety has be- (d) If printed publications are cited come open for use by the public and, if as a reason for denial, the author (if previously specified to be sold by vari- any), title, date, pages or plates, and ety name as ‘‘certified seed only,’’ that places of publication, or place where a such restriction no longer applies. copy can be found shall be given.
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(e) When a denial is based on facts for denial in the same manner as after known to the examiner, and upon re- the first examination. Any such denial quest by the applicant, the denial shall shall be final unless appealed by the be supported by the affidavit of the ex- applicant to the Secretary within 60 aminer. Such affidavit shall be subject days from the date of denial, in accord- to contradiction or explanation by the ance with §§ 97.300–97.303. If the denial affidavits of the applicant and other is sustained by the Secretary on ap- persons. peal, the denial shall be final subject to (f) Abandoned applications may not appeal to the courts, as provided in be cited as reasons for denial. § 97.500. [58 FR 42435, Aug. 9, 1993, as amended at 60 FR 17189, Apr. 4, 1995] § 97.108 Amendments after final ac- tion. § 97.106 Reply by applicant; request (a) After a final denial by the Com- for reconsideration. missioner, amendments to the applica- (a) After an adverse action by the ex- tion may be made to overcome the rea- aminer, the applicant may respond to son or reasons for denial. The accept- the denial and may request a reconsid- ance or refusal of any such amendment eration, with or without amendment of by the Office and any proceedings rel- his or her application. Any amendment ative thereto shall not relieve the ap- shall be responsive to the reason or plicant from the time limit set for an reasons for denial specified by the ex- appeal or an abandonment for failure aminer. to reply. (b) To obtain a reconsideration, the (b) No amendment of the application applicant shall submit a request for re- can be made in an appeal proceeding. consideration in writing and shall spe- After decision on appeal, amendments cifically point out the alleged errors in can only be made to carry into effect a the examiner’s action. The applicant recommendation under § 97.302(b). shall respond to each reason cited by the examiner as the basis for the ad- CORRECTION OF ERRORS IN CERTIFICATE verse action. A request for reconsider- ation of a denial based on a faulty form § 97.120 Corrected certificate—office or procedure may be held in abeyance mistake. by the Commissioner until the ques- When a certificate is incorrect be- tion of the variety being new, distinct, cause of a mistake in the Office, the uniform, and stable is settled. Commissioner may issue a corrected (c) An applicant’s request for a recon- certificate stating the fact and nature sideration must be a bona fide attempt of such mistake, under seal, without to advance the case to final action. A charge, to be issued to the owner and general allegation by the applicant recorded in the records at the Office. that certain language which he or she cites in the application or amendment § 97.121 Corrected certificate—appli- thereto establishes the variety is new, cant’s mistake. distinct, uniform, and stable without When a certificate is incorrect be- specifically explaining how the lan- cause of a mistake by the applicant of guage distinguishes the alleged new, a clerical or typographical nature, or distinct, uniform, and stable variety of minor character, or in the descrip- from the material cited by the exam- tion of the variety (including, but not iner shall not be grounds for a recon- limited to, the use of a misleading va- sideration. riety name or a name assigned to a dif- [58 FR 42435, Aug. 9, 1993, as amended at 60 ferent variety of the same species), and FR 17190, Apr. 4, 1995] the mistake is found by the Commis- sioner to have occurred in good faith § 97.107 Reconsideration and final ac- and does not require a further exam- tion. ination, the Commissioner may, upon If, upon reconsideration, the applica- payment of the required fee and return tion is denied by the Commissioner, of the original certificate, correct the the applicant shall be notified by the certificate by issuing a corrected cer- Commissioner of the reason or reasons tificate, in accordance with section 85
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of the Act. If the mistake requires a re- petent jurisdiction. The Office shall examination, a correction of the cer- not determine whether conditions tificate shall be dependent on the re- precedent to the assignment, such as sults of the reexamination. the payment of money, have been ful- filled. REISSUANCE OF CERTIFICATE § 97.132 Assignment records open to § 97.122 Certified seed only election. public inspection. When an owner elects after a certifi- (a) Assignment records relating to cate is issued to sell the protected vari- original or amended certificates shall ety by variety name only as a class of be open to public inspection and copies certified seed, a new certificate may be of any recorded document may be ob- issued upon return of the original cer- tained upon payment of the prescribed tificate to the Office and payment of fee. the appropriate fee. (b) Assignment records relating to ASSIGNMENTS AND RECORDING any pending or abandoned application shall not be available for inspection ex- § 97.130 Recording of assignments. cept to the extent that pending appli- (a) Any assignment of an application cations are published as provided in for a certificate, or of a certificate of section 57 of the Act and § 97.19, or plant variety protection, or of any in- where necessary to carry out the provi- terest in a variety, or any license or sions of any Act of Congress. Copies of grant and conveyance of any right to assignment records and information on use of the variety, may be submitted pending or abandoned applications for recording in the Office in accord- shall be obtainable only upon written ance with section 101 of the Act (7 authority of the applicant or his or her U.S.C. 2531). assignee, or attorney or agent of (b) No instrument shall be recorded record, or where necessary to carry out which is not in the English language or the provisions of any Act of Congress. which does not identify the certificate An order for a copy of an assignment or application to which it relates. shall give the proper identification of (c) An instrument relating to title of the assignment. a certificate shall identify the certifi- MARKING OR LABELING PROVISIONS cate by number and date, the name of the owner, and the name of the variety § 97.140 After filing. as stated in the certificate. An instru- ment relating to title of an application Upon filing an application for protec- shall identify an application by number tion of a variety and payment of the and date of filing, the name of the prescribed fee, the owner, or his or her owner, and the name of the variety as designee, may label the variety or con- stated in the application. tainers of the seed of the variety or (d) If an assignment is executed con- plants produced from such seed, sub- currently or subsequent to the filing of stantially as follows: ‘‘Unauthorized an application, but before its number Propagation Prohibited—(Unauthor- and filing date are ascertained, the as- ized Seed Multiplication Prohibited)— signment shall identify the application U.S. Variety Protection Applied For.’’ by the date of the application, the Where applicable, ‘‘PVPA 1994’’ or name of the owner, and the name of the ‘‘PVPA 1994—Unauthorized Sales for variety. Reproductive Purposes Prohibited’’ may be added to the notice. [58 FR 42435, Aug. 9, 1993, as amended at 60 FR 17190, Apr. 4, 1995] [58 FR 42435, Aug. 9, 1993, as amended at 60 FR 17190, Apr. 4, 1995; 61 FR 248, Jan. 4, 1996] § 97.131 Conditional assignments. Assignments recorded in the Office § 97.141 After issuance. are regarded as absolute assignments Upon issuance of a certificate, the for Office purposes until canceled in owner of the variety, or his or her des- writing by both parties to the assign- ignee, may label the variety or con- ment or by a decree of a court of com- tainers of the seed of the variety or
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plants produced from such seed sub- ATTORNEYS AND AGENTS stantially as follows: ‘‘Unauthorized Propagation Prohibited—(Unauthor- § 97.150 Right to be represented. ized Seed Multiplication Prohibited)— An applicant may actively advance U.S. Protected Variety.’’ Where appli- an application or may be represented cable, ‘‘PVPA 1994’’ or ‘‘PVPA 1994— by an attorney or agent authorized in Unauthorized Sales for Reproductive writing. Purposes Prohibited’’ may be added to the notice. § 97.151 Authorization. [58 FR 42435, Aug. 9, 1993, as amended at 60 Only attorneys or agents specified by FR 17190, Apr. 4, 1995; 61 FR 248, Jan. 4, 1996] the applicant shall be allowed to in- spect papers or take action of any § 97.142 For testing or increase. kind, on behalf of the applicant, in any An owner who contemplates filing an pending application or proceedings. application and releases for testing or § 97.152 Revocation of authorization; increase, seed of the variety or repro- withdrawal. ducible plant material of the variety, may label such plant material or con- An authorization of an attorney or tainers of the seed or plant material agent may be revoked by an applicant substantially as follows: ‘‘Unauthor- at any time, and an attorney or agent ized Propagation Prohibited—For Test- may withdraw, upon application to the ing (or Increase) Only.’’ Commissioner. When the authorization is so revoked, or the attorney or agent [58 FR 42435, Aug. 9, 1993, as amended at 60 has so withdrawn, the Office shall in- FR 17190, Apr. 4, 1995] form the interested parties and shall thereafter communicate directly with § 97.143 Certified seed only. the applicant, or with such other attor- (a) Upon filing an application, or ney or agent as the applicant may ap- amendment thereto, specifying seed of point. An assignment will not of itself the variety is to be sold by variety operate as a revocation of authoriza- name only as a class of certified seed, tion previously given, but the assignee the owner, or his or her designee, may of the entire interest may revoke pre- label containers of seed of the variety vious authorizations and be rep- substantially as follows: ‘‘Unauthor- resented by an attorney or agent of his ized Propagation Prohibited—U.S. Va- or her own selection. riety Protection Applied for Specifying That Seed of This Variety Is To Be § 97.153 Persons recognized. Sold By Variety Name Only as a Class Unless specifically authorized as pro- of Certified Seed.’’ vided in § 97.151, no person shall be per- (b) An owner who has received a cer- mitted to file or advance applications tificate specifying that a variety is to before the Office on behalf of another be sold by variety name only, as a class person. of certified seed, may label containers of the seed of the variety substantially § 97.154 Government employees. as follows: ‘‘Unauthorized Propagation Officers and employees of the United Prohibited—To Be Sold By Variety States who are disqualified by statute Name Only as a Class of Certified Seed (18 U.S.C. 203 and 205) from practicing —U.S. Protected Variety.’’ as attorneys or agents in proceedings or other matters before government de- § 97.144 Additional marking or label- partments or agencies, shall not be eli- ing. gible to represent applicants, except of- Additional clarifying information ficers and employees whose official du- that is not false or misleading may be ties require the preparation and pros- used by the owner, in addition to the ecution of applications for certificates above markings or labeling. of variety protection.
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§ 97.155 Signatures. (a) Filing the application and noti- fying the public of filing—$320.00. Every document filed by an attorney (b) Search or examination—$2,385.00. or agent representing an applicant or (c) Allowance and issuance of certifi- party to a proceeding in the Office cate and notifying public of issuance— shall bear the signature of such attor- $320.00. ney or agent, except documents which (d) Revive an abandoned applica- are required to be signed by the appli- tion—$320.00. cant or party. (e) Reproduction of records, draw- ings, certificates, exhibits, or or point- § 97.156 Addresses. ed material (copy per page of mate- Attorneys and agents practicing be- rial)—$1.10. fore the Plant Variety Protection Of- (f) Authentication (each page)—$1.10. fice shall notify the Office in writing of (g) Correcting or re-issuance of a cer- any change of address. The Office shall tificate—$320.00. address letters to any person at the (h) Recording assignments (per cer- last address received. tificate/application)—$28.00. (i) Copies of 8 x 10 photographs in § 97.157 Professional conduct. color—$28.00. Attorneys and agents appearing be- (j) Additional fee for reconsider- fore the Office shall conform to the ation—$320.00. standards of ethical and professional (k) Additional fee for late payment— conduct, generally applicable to attor- $28.00. neys appearing before the courts of the (l) Additional fee for late replenish- United States. ment of seed—$28.00. (m) Appeal to Secretary (refundable § 97.158 Advertising. if appeal overturns the Commissioner’s decision)—$3,050.00. (a) The use of advertising, circulars, (n) Granting of extensions for re- letters, cards, and similar material to sponding to a request—$55.00. solicit plant variety protection busi- (o) Field inspections by a representa- ness, directly or indirectly, is forbidden tive of the Plant Variety Protection as unprofessional conduct, and any per- Office, made at the request of the ap- son engaging in such solicitation, or plicant, shall be reimbursable in full associated with or employed by others (including travel, per diem or subsist- who so solicit, shall be refused recogni- ence, and salary) in accordance with tion to practice before the Office or Standardized Government Travel Regu- may be suspended, excluded, or dis- lations. barred from further practice before the (p) Any other service not covered Office. above will be charged for at rates pre- (b) The use of simple professional let- scribed by the Commissioner, but in no terheads, calling cards, or office signs, event shall they exceed $66.00 per em- simple announcements necessitated by ployee-hour. opening an office, change of associa- tion, or change of address, distributed [65 FR 47244, Aug. 2, 2000] to clients and friends and insertion of listings in common form (not display) § 97.176 Fees payable in advance. in a classified telephone or city direc- Fees and charges shall be paid at the tory, and listings and professional time of making application or at the cards with biographical data in stand- time of submitting a request for any ard professional directories, shall not action by the Office for which a fee or be considered a violation of this sec- charge is payable and established in tion. this part.
FEES AND CHARGES § 97.177 Method of payment. Checks or money orders shall be § 97.175 Fees and charges. made payable to the Treasurer of the The following fees and charges apply United States. Remittances from for- to the services and actions specified eign countries must be payable and im- below: mediately negotiable in the United
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States for the full amount of the pre- show the reason or reasons for oppos- scribed fee. Money sent by mail to the ing the application or certificate. The Office shall be sent at the sender’s risk. petition and accompanying papers shall be filed in duplicate. If it appears § 97.178 Refunds. to an examiner that a variety involved Money paid by mistake or excess in a pending application or covered by payments shall be refunded, but a mere a certificate may not be or may not change of plans after the payment of have been entitled to protection under money, as when a party decides to the Act, a protest proceeding may be withdraw an application or to with- permitted by the Commissioner. draw an appeal, shall not entitle a (b) One copy of the petition and ac- party to a refund. However, the exam- companying papers shall be served by ination or search fee shall be refunded the Office upon the applicant or owner, if an application is voluntarily aban- or his or her attorney or agent of doned pursuant to § 97.23(a) before a record. search or examination has begun. (c) An answer, by the applicant or Amounts of $1 or less shall not be re- owner of the certificate, or his or her funded unless specifically demanded. assignee, in response to the petition, may be filed with the Commissioner § 97.179 Copies and certified copies. within 60 days after service of the peti- (a) Upon request, copies of applica- tion, upon such person. If no answer is tions, certificates, or of any records, filed within said period, the Commis- books, papers, drawings, or photo- sioner shall decide the matter on the graphs in the custody of the Office and basis of the allegations set forth in the which are open to the public, will be petition. furnished to persons entitled thereto, (d) If the petition and answer raise upon payment of the prescribed fee. any issue of fact needing proof, the (b) Upon request, copies will be au- Commissioner shall afford each of the thenticated by imprint of the seal of parties a period of 60 days in which to the Office and certified by the official, file sworn statements or affidavits in authorized by the Commissioner upon support of their respective positions. payment of the prescribed fee. (e) As soon as practicable after the petition or the petition and answer are AVAILABILITY OF OFFICE RECORDS filed, or after the expiration of any pe- riod for filing sworn statements or affi- § 97.190 When open records are avail- davits, the Commissioner shall issue a able. decision as to whether the protests are Copies of records, which are open to upheld or denied. The Commissioner the public and in the custody of the Of- may, following the protest proceeding, fice, may be examined in the Office cancel any certificate issued and may during regular business hours upon ap- grant another certificate for the same proval by the Commissioner. variety to a person who proves to the satisfaction of the Commissioner, that PROTEST PROCEEDINGS he or she is the breeder or discoverer. The decision shall be served upon the § 97.200 Protests to the grant of a cer- parties in the manner provided in tificate. § 97.403. Opposition on the part of any person [58 FR 42435, Aug. 9, 1993, as amended at 60 to the granting of a certificate shall be FR 17190, Apr. 4, 1995] permitted while an application is pend- ing and for a period not to exceed 5 PRIORITY CONTEST2 years following the issuance of a cer- tificate. § 97.205 Definition; when declared. A priority contest may be instituted § 97.201 Protest proceedings. by the Secretary, on his or her own (a) Opposition shall be made by sub- mitting in writing a petition for pro- 2 All provisions relating to priority con- test proceedings, which petition shall tests apply only to varieties protected under be supported by affidavits and shall Continued
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motion, or upon the request of any per- test. The notice shall specify a time, son who has applied for protection on not to exceed 2 months, for filing pre- the same variety, for which an adverse liminary statements. certificate has been issued, for the pur- (c) When a notice is returned to the pose of determining the question of pri- Office undelivered, or when one of the ority between two or more parties parties resides abroad and his or her claiming development or discovery of agent in the United States is unknown, the same novel variety; Provided, how- notice may be given once by publica- ever, That any person shall have for- tion in the Official Journal. feited his or her right to assert priority when an adverse certificate has been § 97.208 Burden of proof. issued, if he or she fails to make a re- The parties to a priority contest will quest for the institution of a priority be presumed to have developed their contest within 1 year of the publication varieties in the chronological order of in the Official Journal of issuance of the filing dates of their applications the adverse certificate by the Sec- for certificates involved in the priority retary, or if he or she fails to make the contest, and the burden of proof will request within the period for taking ac- rest upon the party who last filed an tion after refusal of the application on application. the basis of the adverse certificate. § 97.209 Preliminary statement on § 97.206 Preparation for priority con- novel variety developed in the test between applicants. United States. (a) Before a priority contest will be (a) Each party to the priority contest handled by the Office, an examiner is required to file on or before a date must determine that the same novel fixed by the Office, a concise prelimi- variety is involved in separate applica- nary statement giving the facts and tions filed by two or more parties and dates relating to the development of apparently certifiable to each of the his or her alleged novel variety. The parties, subject to the determination of preliminary statement must be signed the question of priority. by the owner; Provided, however, That (b) The fact that a certificate has in appropriate circumstances, as when been issued will not prevent a priority the owner is dead or legally incapaci- contest. tated, or a showing is made of inability to obtain a statement from the owner, § 97.207 Preparation of priority papers the preliminary statement may be and declaration of priority contest. made by the assignee or by someone (a) When a priority question is found authorized or entitled to make the to exist, the examiner shall forward statement, having knowledge of the the pertinent files to the Commis- facts. sioner, together with a written state- (b) Preliminary statements shall be ment showing the reason for the con- filed with the Office in duplicate. A test. copy shall be forwarded to each oppos- (b) The Commissioner shall institute ing party by the Office as soon as prac- and declare the priority contest by for- ticable after both parties have filed warding a notice to each of the appli- their statements within the requisite cants involved. Each notice shall in- period. clude the name and residence of each of (c) In filing a preliminary statement the other applicants or those of his or each party must show the following in- her attorney or agent, if any, and of formation: any assignee, and will identify the ap- (1) The date upon which the first de- plication of each opposing party by termination of the novel variety was number and filing date, or in the case made. of a certificate, by the number and (2) The date upon which the first date of the certificate. The notice shall written description of the novel variety specify the basis of the priority con- was made. If a written description of the novel variety has not been made the Act as it was in force prior to April 4, prior to the filing date of the applica- 1995. tion, it must be so stated.
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(3) The date of the first act or acts § 97.212 Correction of a statement on susceptible of proof (other than making motion. a written description or disclosing the In case of material error arising novel variety to another person), through inadvertence or mistake, a which, if proven, would establish deter- preliminary statement may be cor- mination of the novel variety, and a rected upon a satisfactory showing to brief description of such act or acts. If the Commissioner that the correction there have been no such acts, it must is of material significance. Correction be so stated. of the statement must be made as soon (4) The date of the actual production as practicable after the discovery of of the novel variety. If the novel vari- the error. ety had not been actually produced be- § 97.213 Failure to file statements. fore the filing date of the application, it must be so stated. If any party to a priority contest fails to file a preliminary statement, (d) When an allegation as to the first he or she shall be restricted to his or written description (paragraph (c)(2) of her earliest effective filing date. this section) is made, a copy of such written description shall be attached § 97.214 Access to preliminary state- to the statement. ments. (e) If a party intends to rely on a The preliminary statements shall be prior application, domestic or foreign, open to the inspection of any party the preliminary statement shall clear- after the date set for the filing of pre- ly identify such prior application. Cop- liminary statements (§ 97.207(b)), but ies of the cited application and related shall not be open to inspection prior to documents will be served by the Office, that time. upon all interested parties to the con- test. In the case of an application filed § 97.215 Dissolution at the request of the Commissioner. in a foreign country, English trans- lations shall be served to all interested If during a priority contest, informa- parties by the party relying on the ap- tion is submitted or found which, in plication filed in the foreign country. the opinion of the Commissioner, may render the variety ineligible for a cer- § 97.210 Preliminary statement on tificate, the priority contest may be novel variety developed in a foreign suspended by the Commissioner and re- country. ferred to an examiner for consideration of the matter. The parties will be noti- When the novel variety was devel- fied of the reason for the suspension. oped in a foreign country, the prelimi- Arguments of the parties regarding the nary statement must show (a) the in- suspension will be considered, if filed formation specified in § 97.209 (c) within 60 days of the notification. The through (e) and (b) whether, and if so, suspension will then be continued, when and under what circumstances modified, or dismissed, in accordance the novel variety was introduced into with the determination by the Com- the United States by or on behalf of missioner. the party. § 97.216 Concession; abandonment. § 97.211 Statements sealed before fil- (a) An applicant or a certificate hold- ing. er involved in a priority contest may, The preliminary statement shall be at any time, file a written concession submitted in a sealed envelope bearing of priority, or abandonment of the cer- the name of the party filing it and the tificate, signed by him or her. Upon the number and title of the priority con- filing of such an instrument by any test as shown on the notice issued by party, the decision shall be rendered the Office. The envelope should be en- against the interested party by the Commissioner. closed in an outer mailing envelope (b) A concession of priority may not marked ‘‘To Be Opened Only by the be made by an assignee of a part inter- Commissioner.’’ est.
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§ 97.217 Affidavits and exhibits. specified period, not less than 30 days, Affidavits and exhibits, including of- to show cause why such proposed find- ficial records and any special matter ings of fact, conclusions, and notice of contained in a printed publication, per- priority should not be made final. Any tinent to the issue involved in the con- response made during the specified pe- test, may be introduced as evidence in riod will be considered by the Commis- a priority contest by any party to the sioner. Additional affidavits or exhibits contest. In the case of official records will not be considered, unless accom- and printed publications, the party in- panied by a showing of good cause ac- troducing the evidence shall specify ceptable to the Commissioner. There- the record or the printed publication, after, final findings of fact, conclu- the page or pages to be used, indicate sions, and notice of priority shall be generally its relevancy, and submit to issued by the Commissioner. the Commissioner the record or au- (b) The decision shall be entered by thenticated copy, or the printed publi- the Commissioner against a party cation, or a copy. Copies of affidavits whose preliminary statement alleges a and exhibits, including any record or date of determination later than the publication, shall be served by the filing date of the other party’s applica- Commissioner on each of the other in- tion. terested parties. § 97.221 Status of claims of defeated § 97.218 Matters considered in deter- applicant. mining a priority. In determining priority, the Commis- Whenever a final notice of priority sioner will consider only priority of de- has been issued by the Commissioner in velopment based on the evidence sub- a priority proceeding, and the time mitted. Questions of novelty generally limit for an appeal from such decision will not be considered in the decision has expired, the claim or claims consti- on priority. The Commissioner may tuting the issue of the priority stand refer proposed findings of fact, conclu- finally disposed of without further ac- sions, and notice of priority to the tion by the Commissioner. Board for an advisory decision. § 97.222 Second priority contest. § 97.219 Recommendation by the Com- A second priority contest between missioner. the same parties shall not be enter- The Commissioner may, either before tained by the Commissioner for the or concurrently with a decision on the same novel variety. question of priority, but independently of such decision, direct the attention of APPEAL TO THE SECRETARY the examiner to any matter not relat- ing to priority which may come to the § 97.300 Petition to the Secretary. Commissioner’s attention, and which (a) Petition may be made to the Sec- in his or her opinion establishes the retary from any final action of the fact that there has been an irregularity Commissioner denying an application which amounts to a bar to the granting of a certificate to either of the parties. or refusing to allow a certificate to be The Commissioner may suspend the issued, or from any adverse decision of priority contest and remand the case the Commissioner made under to the examiner for further consider- §§ 97.18(c), 97.107, 97.201(e), and 97.220. ation of the matters, to which atten- (b) Any such petition shall contain a tion has been directed. statement of the facts involved and the point or points to be reviewed, and the § 97.220 Decision by the Commissioner. actions requested. (a) When a priority contest is con- (c) A petition to the Secretary shall cluded on the basis of preliminary be filed in duplicate and accompanied statements, or proposed findings of by the prescribed fee (see § 97.175). fact, conclusions and notice of priority (d) Upon request, an opportunity to shall be issued by the Commissioner to present data, views, and arguments the interested parties, giving them a orally, in an informal manner or in a
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formal hearing, shall be given to inter- of the decision requires further action ested persons. If a formal hearing is re- by the Commissioner. If the decision of quested, the proceeding shall be con- the Secretary is appealed or a civil ac- ducted in accordance with the Rules of tion has been filed pursuant to the Act, Practice Governing Formal Adjudica- the decision of the Secretary will be tory Proceedings Instituted by the Sec- stayed pending the outcome of the retary Under Various Statutes set court appeal or civil action. forth in §§ 1.130 through 1.151 of this [58 FR 42435, Aug. 9, 1993, as amended at 60 title. FR 17190, Apr. 4, 1995] (e) Except as otherwise provided in the rules in this part, any such petition GENERAL PROCEDURES IN PRIORITY, not filed within 60 days from the action PROTEST, OR APPEAL PROCEEDINGS complained of shall be dismissed as un- timely. § 97.400 Extensions of time. [58 FR 42435, Aug. 9, 1993, as amended at 60 Upon a showing of good cause, exten- FR 8464, Feb. 14, 1995] sions of time not otherwise provided for may be granted by the Commis- § 97.301 Commissioner’s answer. sioner or, if an appeal has been filed by (a) The Commissioner may, within the Secretary for taking any action re- such time as may be directed by the quired in any priority, protest, or ap- Secretary, furnish a written statement peal proceeding. to the Secretary in answer to the ap- pellant’s petition, including such ex- § 97.401 Miscellaneous provisions. planation of the reasons for the action (a) Petitions for reconsideration or as may be necessary and supplying a modification of the decision of the copy to the appellant. Commissioner in priority or protest (b) Within 20 days from the date of proceedings shall be filed within 20 such answer, the appellant may file a days after the date of the decision. reply statement directed only to such (b) The Commissioner may consider new points of argument as may be on petition any matter involving abuse raised in the Commissioner’s answer. of discretion in the exercise of an ex- aminer’s authority, or such other mat- § 97.302 Decision by the Secretary. ters as may be deemed proper to con- (a) The Secretary, after receiving the sider. Any such petition, if not filed advice of the Board, may affirm or re- within 20 days from the decision com- verse the decision of the Commis- plained of, may be dismissed as un- sioner, in whole or in part. timely. (b) Should the decision of the Sec- retary include an explicit statement § 97.402 Service of papers. that a certificate be allowed, based on (a) Every paper required to be served an amended application, the applicant on opposing parties and filed in the Of- shall have the right to amend his or fice in any priority, protest, or appeal her application in conformity with proceeding, must be served by the Sec- such statement and such decision shall retary in the manner provided in be binding on the Commissioner. § 97.403. (b) The requirement in certain sec- § 97.303 Action following the decision. tions that a specified paper shall be (a) Copies of the decision of the Sec- served includes a requirement that all retary shall be served upon the appel- related supporting papers shall also be lant and the Commissioner in the man- served. Proof of such service upon ner provided in § 97.403. other parties to the proceeding must be (b) When an appeal petition is dis- made before the supporting papers will missed, or when the time for appeal to be considered by the Commissioner or the courts pursuant to the Act has ex- Secretary. pired and no such appeal or civil action has been filed, proceedings in the ap- § 97.403 Manner of service. peal shall be considered terminated as Service of any paper under this part of the dismissal or expiration date, ex- must be on the attorney or agent of the cept in those cases in which the nature party if there be such, or on the party
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if there is no attorney or agent, and PUBLIC USE DECLARATION may be made in any of the following ways: § 97.700 Public interest in wide usage. (a) By mailing a copy of the paper to (a) If the Secretary has reason to be- the person served by certified mail, lieve that a protected variety should be with the date of the return receipt con- declared open to use by the public in trolling the date of service; accordance with section 44 of the Act, (b) By leaving a copy at the usual the Secretary shall give the owner of place of business of the person served the variety appropriate notice and an with someone in his or her employ; opportunity to present views orally or (c) When the person served has no in writing, with regard to the necessity usual place of business, by leaving a for such action to be taken in the pub- copy at his or her home with a member lic interest. of the family over 14 years of age and (b) Upon the expiration of the period of discretion; and for the presentation of views by the (d) Whenever it shall be found by the owner, as provided in paragraph (a) of Commissioner or Secretary that none this section, the Secretary shall refer of the above modes of serving the paper the matter to the Plant Variety Pro- is practicable, service may be by no- tection Board for advice, including ad- tice, published once in the Office Jour- vice on any limitations or rate of re- nal. muneration. REVIEW OF DECISIONS BY COURT (c) Upon receiving the advice of the Plant Variety Protection Board, the § 97.500 Appeal to U.S. Courts. Secretary shall advise the owner of the Any applicant dissatisfied with the variety, the members of the Plant Va- decision of the Secretary on appeal riety Protection Board, and the public, may appeal to the U.S. Court of Cus- by issuance of a press release, of any toms and Patent Appeals or the U.S. decision based on the provisions of sec- Courts of Appeals, or institute a civil tion 44 of the Act to declare a variety action in the U.S. District Court as set open to use by the public. Any decision forth in the Act. In such cases, the ap- not to declare a variety open to use by pellant or plaintiff shall give notice to the public will be transmitted only to the Secretary, state the reasons for ap- the owner of the variety and the mem- peal or civil action, and obtain a cer- bers of the Plant Variety Protection tified copy of the record. The certified Board. copy of the record shall be forwarded to PUBLICATION the Court by the Plant Variety Protec- tion Office on order of, and at the ex- § 97.800 Publication of public variety pense of the appellant or plaintiff. descriptions. [58 FR 42435, Aug. 9, 1993, as amended at 60 Voluntary submissions of varietal de- FR 17190, Apr. 4, 1995] scriptions of ‘‘public varieties’’ on forms obtainable from the Office will CEASE AND DESIST PROCEEDINGS be accepted for publication in the Offi- § 97.600 Rules of practice. cial Journal. Such publication shall not constitute recognition that the va- Any proceedings instituted under riety is, in fact, distinct, uniform, and section 128 of the Act for false marking stable. shall be conducted in accordance with §§ 202.10 through 202.29 of this chapter [58 FR 42435, Aug. 9, 1993, as amended at 60 (rules of practice under the Federal FR 17190, Apr. 4, 1995] Seed Act) (7 U.S.C. 1551 et seq.), except that all references in those rules and § 97.900 Form of official identification regulations to ‘‘Examiner’’ shall be symbol. construed to be an Administrative Law The symbol set forth in Figure 1, Judge, U.S. Department of Agriculture, containing the words ‘‘Plant Variety and not an ‘‘Examiner’’ as defined in Protection Office’’ and ‘‘U.S. Depart- the regulations under the Plant Vari- ment of Agriculture,’’ shall be the offi- ety Protection Act. cial identification symbol of the Plant
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Variety Protection Office. This infor- tion, has been approved by the Office of mation symbol, used by the Plant Vari- Communications to be added to the ety Protection Office on the seal on USDA/AMS inventory of symbols. It is certificates of Plant Variety Protec- approved for use with AMS materials.
[65 FR 47244, Aug. 2, 2000]
PART 98—MEALS, READY-TO-EAT Subpart A—MRE’s, Meats, and (MRE’s), MEATS, AND MEAT Related Meat Food Products PRODUCTS § 98.1 General. Subpart A–MRE’s, Meats, and Related Meat Analytical services of meat and meat Food Products food products are performed for fat, moisture, salt, protein, and other con- Sec. tent specifications. 98.1 General. 98.2 Definitions. § 98.2 Definitions. 98.3 Analyses performed and locations of Words used in the regulations in this laboratories. subpart in the singular form will im- 98.4 Analytical methods. port the plural, and vice versa, as the 98.5 Fees and charges. case may demand. As used throughout the regulations in this subpart, unless Subpart B—USDA Certification of Labora- the context requires otherwise, the fol- tories for the Testing of Trichinae in lowing terms will be construed to Horsemeat mean: 98.100 General. Lard (Edible). The fat rendered from 98.101 Definitions. clean and sound edible tissues from 98.102–98.600 [Reserved] swine. Meals, Ready-To-Eat (MRE). Meals, AUTHORITY: 7 U.S.C. 1622, 1624. Ready-To-Eat are complete portions of SOURCE: 58 FR 42445, Aug. 9, 1993, unless one meal for one military person and otherwise noted. are processed and packaged to destroy
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or retard the growth of spoilage-type wholly or in substantial part from microorganisms in order to extend meat or other portion of the carcass of product shelf life for 7 years. Composi- any cattle, sheep, swine, or goats. An tion analyses for MRE’s are covered by article exempted from definition as a the reimbursable agreement in the meat food product by the Adminis- Memorandums of Understanding trator, such as an organotherapeutic (MOU’s) between AMS, USDA and the substance, meat juice, meat extract, Defense Personnel Support Center, De- and the like, which is used only for me- partment of Defense (DOD). These dicinal purposes and is advertised sole- DOD, Defense Personnel Support Cen- ly to the medical profession is not in- ter (DPSC) contracts state certain cluded. military specifications for an accept- Ready-to-eat. The term means con- able one meal serving, retorted sumers are likely to apply little or no pouched or 18–24 serving hermetically- additional heat to the fully-cooked and sealed tray packed meat, or meal prod- the fully-prepared food product before uct regarding satisfactory analyses for consumption. fat, salt, protein, moisture content, Specifications. Descriptions with re- added stabilizer ingredient, and some- spect to the class, grade, other quality, times microbiological composition. quantity or condition of products, ap- MRE’s are for use by the DOD, DPSC as proved by the Administrator, and a component of operational food ra- available for use by the industry re- tions, and as an item of general issue gardless of the origin of the descrip- by the military. tions. Meat. This includes the edible part of Tallow (Edible). The hard fat derived the muscle of any cattle, sheep, swine, from USDA inspected and passed cat- or goats, which is skeletal or which is found in the tongue, in the diaphragm, tle, sheep, or goats. in the heart, or in the esophagus, and Titer. The measure of the hardness or which is intended for human food, with softness of the tested material as de- or without the accompanying and over- termined by the solidification point of lying fat, and the portions of bone, fatty acids and expressed in degrees skin, tendon, nerve, and blood vessels centigrade (°C). which normally accompany the muscle tissue, and which are not separated § 98.3 Analyses performed and loca- tions of laboratories. from it in the process of dressing. It does not include the muscle found in (a) Tables 1 through 4 list the special the lips, snout, or ears. This term, as laboratory analyses rendered by the applied to products of equines, shall Science and Technology as a result of have a meaning comparable to that an agreement with the Livestock and provided in this paragraph with respect Seed Division. The payment for such to cattle, sheep, swine, and goats. laboratory services rendered at the re- Meat food product. Any article capa- quest of an individual or third party ble for use as human food (other than served shall be reimbursed pursuant to meat, prepared meat, or a meat by- the terms as specified in the coopera- product), which is derived or prepared tive agreement.
TABLE 1—SCHEDULE ANALYSIS
Samples Identity Analyses tested
Schedule BC (Beef Chunks, Canned) ...... Fat, salt ...... 1 Schedule BJ (Beef with Natural Juices, Canned) ...... Fat ...... 1 Schedule CS (Canned Meatball Stew) ...... Fat ...... 3 Schedule GP (Frozen Ground Pork) ...... Fat ...... 4 Schedule PJ (Pork with Natural Juices, Canned) ...... Fat ...... 1 Schedule RB (Beef for Reprocessing) ...... Fat ...... 4 Schedule RG (Beef Roasts and Ground Beef) ...... Fat ...... 4 Schedule SB (Slab or Sliced Bacon) ...... Moisture, fat, salt 1 Schedule WS (Beef or Wafer Steaks) ...... Fat ...... 1
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TABLE 2—MICROBIOLOGICAL ANALYSIS
Number of Type of analysis samples tested
Psychrotrophic Bacterial Plate Count ...... 1
TABLE 3—NONSCHEDULE ANALYSIS
Samples Identity Analyses tested
Fed Specification PP-BÐ2120B (Ground Beef Products) ...... Fat ...... 4 Fed Specification PP-BÐ81J (Sliced Bacon) ...... Fat, salt, moisture 1 Fed Specification PP-LÐ800E (Luncheon Meat, Canned) ...... Fat, salt ...... 1 Ground Beef or Ground Pork ...... Fat ...... 4 Ground Beef or Ground Pork ...... Fat ...... 1 Pork Sausage ...... Fat, salt ...... 4 Pork Sausage ...... Fat, moisture ...... 4 Pork Sausage ...... Fat ...... 4 Mil-PÐ44131A (Pork Steaks, Flaked, Formed, Breaded) ...... Fat ...... 4 Milwaukee Public Schools (Breaded/Unbreaded Meat) ...... Fat ...... 4 Chili Con Carne Without Beans ...... Fat ...... 1 A-AÐ20047ÐB ...... Fat, protein ...... 3 A-AÐ20136 ...... salt ...... 3 A-AÐ20148 ...... Fat, salt ...... 3 Mil-BÐ44133 (GL) ...... Fat, salt ...... 3 Mil-BÐ44158A ...... Water activity ...... 6 Mil-CÐ44253 ...... Fat, salt ...... 3 Mil-HÐ44159B (GL) ...... Fat, salt ...... 1 PP-FÐ02154 (Army GL) ...... Fat, salt, moisture 1
TABLE 4—LARD AND TALLOW ANALYSIS
Number of Type of analysis samples tested
Fat Analysis Committee (FAC) Color ...... 1 Free Fatty Acids ...... 1 Insoluble Impurities ...... 1 Moisture and Volatile Matter ...... 1 Specific Gravity ...... 4 to 6 Titer Test ...... 1 Unsaponifiable Material ...... 1
(b) Meats, such as ground beef or (3) USDA, AMS, S&T, Eastern Labora- ground pork, meat food products, and tory, 2311–B Aberdeen Boulevard, MRE’s, not covered by an agreement Gastonia, NC 28054. with Livestock and Seed Division, are [58 FR 42445, Aug. 9, 1993, as amended at 59 analyzed for fat, moisture, salt, sulfur FR 24325, May 10, 1994; 59 FR 50121, Sept. 30, dioxide, nitrites, sulfites, ascorbates, 1994; 61 FR 51353, Oct. 2, 1996; 65 FR 64318, citric acid, protein, standard plate Oct. 26, 2000] counts, and coliform counts, among other analyses. These food product § 98.4 Analytical methods. analyses are performed at any one of (a) The majority of analytical meth- the Science and Technology (S&T) field ods used by the USDA laboratories to laboratories as follows: perform analyses of meat, meat food (1) USDA, AMS, Science and Tech- products and MRE’s are listed as fol- nology, Midwestern Laboratory, 3570 lows: North Avondale Avenue, Chicago, IL (1) Official Methods of Analysis of 60618. AOAC INTERNATIONAL, Suite 500, 481 (2) USDA, AMS, S&T Aflatoxin Labora- North Frederick Avenue, Gaithersburg, tory, 107 South 4th Street, Madill, OK MD 20877–2417. 73446.
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(2) U.S. Army Individual Protection the plural, and vice versa, as the case Directorate’s Military Specifications, may demand. As used throughout the approved analytical test methods noted regulations in this part, unless the con- therein, U.S. Army Natick Research, text requires otherwise, the following Development and Engineering Center, terms will be construed to mean: Kansas Street, Natick, MA 01760–5017. European Community. The European (b) Additional analytical methods for Community (EC) consists of the initial these foods will be used, from time to 12 European countries and the updated time, as approved by the Director. and expanded membership of nations. The original EC members are Belgium, [58 FR 42445, Aug. 9, 1993, as amended at 61 FR 51353, Oct. 2, 1996] Britain, Denmark, France, Germany, Greece, Ireland, Italy, Luxembourg, § 98.5 Fees and charges. Netherlands, Portugal and Spain. Horsemeat. That U.S. inspected and (a) The fee charged for any single lab- passed clean, wholesome muscle tissue oratory analysis of meat, meat food of horses, which is skeletal or which is products, and MRE’s, not covered by an found in the tongue, in the diaphragm, agreement with Livestock and Seed Di- in the heart, or in the esophagus, with vision, is specified in the schedules of or without the accompanying and over- charges in paragraph (a) of § 91.37 of lying fat and the portions of sinews, this subchapter. nerves, and blood vessels, which nor- (b) The laboratory analyses of meat, mally accompany the muscle tissue meat food products, and MRE’s, not and which are not separated from it in covered by a cooperative agreement, the process of dressing. shall result in an additional fee, found Trichinae. Round worms or nema- in Table 7 of § 91.37 of this subchapter, todes of the genus Trichinella, which for sample preparation or grinding. live as parasites in man, horses, rats, (c) The charge for any requested lab- and other animals. oratory analysis of meat, meat food Trichinella spiralis. A small parasitic products, and MRE’s not listed shall be nematode worm which lives in the flesh based on the standard hourly rate spec- of various animals, including the horse. ified in § 91.37, paragraph (b). When such infected meat is inad- equately cooked and eaten by man, the Subpart B—USDA Certification of live worm multiplies within the body Laboratories for the Testing of and the larvae burrow their way into Trichinae in Horsemeat the muscles, causing a disease referred to as trichinosis. § 98.100 General. §§ 98.102–98.600 [Reserved] A laboratory that has met the re- quirements for certification specified PARTS 99–109 [RESERVED] in this subpart shall receive an AMS Science and Technology certificate to PART 110—RECORDKEEPING ON approve its analysis for Trichinella RESTRICTED USE PESTICIDES BY spiralis in horsemeat. Certification CERTIFIED APPLICATORS; SUR- would be granted to a qualified analyst or a laboratory based on having the VEYS AND REPORTS proper training, facilities, and equip- Sec. ment. This AMS laboratory certifi- 110.1 Scope. cation program will enable horsemeat 110.2 Definitions. exporters to comply with trichinae 110.3 Records, retention, and access to testing requirements of the European records. Community. 110.4 Demonstration of compliance. 110.5 Availability of records to facilitate [58 FR 42445, Aug. 9, 1993, as amended at 61 medical treatment. FR 51353, Oct. 2, 1996; 65 FR 64318, Oct. 26, 110.6 Federal cooperation with States. 2000] 110.7 Penalties. 110.8 Rules of practice. § 98.101 Definitions. 110.9 Miscellaneous. Words used in the regulations in this AUTHORITY: 7 U.S.C. 136a(d)(1)(c), 136i–1, part in the singular form will import and 450; 7 CFR 2.17, 2.50.
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SOURCE: 58 FR 19022, Apr. 9, 1993, unless EPA in accordance with sections 3 or otherwise noted. 24c of the Federal Insecticide, Fun- gicide, and Rodenticide Act and imple- § 110.1 Scope. menting regulations, and borne on the This part sets forth the requirements label of the product. for recordkeeping on restricted use pes- Indian governing body. The governing ticides by all certified applicators, body of any tribe, band, or group of In- both private applicators and commer- dians subject to the jurisdiction of the cial applicators. United States and recognized by the United States as possessing power of § 110.2 Definitions. self-government. As used in this part, the following Licensed health care professional. A terms shall be construed, respectively, physician, nurse, emergency medical to mean: technician, or other qualified indi- Administrator. The Administrator of vidual, licensed or certified by a State the Agricultural Marketing Service, to provide medical treatment. United States Department of Agri- Medical emergency. A situation that culture, or any individual to whom the requires immediate medical treatment Administrator delegates authority to or first aid to treat possible symptoms act in his or her behalf. of pesticide poisoning or exposure. Authorized representative. Any person Parties. Includes the Administrator who is authorized to act on behalf of or cooperating State agencies who in- the Secretary or a State lead agency stitute proceedings against whom such for the purpose of surveying records re- proceedings are instituted, under § 110.8 quired to be kept under this part and of this part. enforcing this part. Person. Any individual, corporation, Certification number. A number issued company, association, firm, partner- by EPA or a State to an individual who ship, society, or other legal entity. is authorized by EPA or the State to Presiding officer. Any individual des- use or supervise the use of any re- ignated in writing by the Adminis- stricted use pesticide. trator to preside at a proceeding con- Certified applicator. Any individual ducted pursuant to § 110.8 of this part. who is certified by EPA or the State to Private applicator. A certified appli- use or supervise the use of any re- cator who uses or supervises the use of stricted use pesticide covered by that any restricted use pesticide for pur- individual’s certification. poses of producing any agricultural Commercial applicator. A certified ap- commodity: plicator, whether or not the individual (1) On property owned or rented by is a private applicator with respect to the applicator or the employer of the some uses, who uses or supervises the applicator; or use of any restricted use pesticide for (2) If applied without compensation, any purpose on any property other other than trading of personal services than as provided by the definition of between producers of agricultural com- private applicator. modities, on the property of another Comparable. With respect to the person. records required to be kept under this Record. The legible recording of all part, similar to those required under required elements under section EPA-approved State certification pro- 110.3(a) (1) through (6) for the applica- grams. tion of a federally restricted use pes- Complainant. The Administrator or ticide.1 an official of a cooperating State that Recordkeeping. The recording by the deals with pesticide use or health or certified applicator, or the agent of the environmental issues related to the certified applicator, of the information pesticide use, who institutes a pro- required by § 110.3(a) and (b) concerning ceeding pursuant to § 110.8 of this part. EPA. The United States Environ- 1 Records can be handwritten on individual mental Protection Agency. notes or forms, consist of invoices, be com- EPA registration number. The number puterized, and or be maintained in record- assigned to a product registered with keeping books.
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each restricted use pesticide applica- may be recorded using any of the fol- tion, either electronically or manually lowing designations: in writing, and the maintenance of (i) County, range, township, and sec- such records in a manner accessible to tion; authorized representatives. (ii) An identification system utilizing Respondent. The party proceeded maps and/or written descriptions which against pursuant to § 110.8 of this part, accurately identify location; restricted use pesticide. A pesticide (iii) An identification system estab- that is federally classified for re- lished by a United States Department stricted use under section 3(d)(1)(c) of of Agriculture agency which utilizes the Federal Insecticide, Fungicide, and maps and numbering system to iden- Rodenticide Act. tify field locations; or Secretary. The Secretary of Agri- (iv) The legal property description. culture, United States Department of (4) The month, day, and year on Agriculture, or any individual to whom which the restricted use pesticide ap- the Secretary delegates authority to plication occurred; and act in his or her behalf. (5) The name and certification num- State. A State of the United States, ber (if applicable) of the certified appli- the District of Columbia, the Common- cator who applied or who supervised wealth of Puerto Rico, the Virgin Is- the application of the restricted use lands, Guam, American Samoa, the pesticide. Northern Mariana Islands, and any (b) Certified applicators shall main- other territory or possession of the tain records of the application of re- United States, or an Indian governing stricted use pesticides made on the body. same day in a total area of less than State lead agency. The agency des- one-tenth (1⁄10) of an acre. Except for ignated by a State to have access to applications of restricted use pesticides the records required to be maintained in greenhouses and nurseries, to which under this part. the requirements of paragraph (a) of Supervise. To provide instruction and this section apply, these records shall guidance in the application of re- include the following information for stricted use pesticides and exercise the application: control over an applicator of restricted (1) The brand or product name, and use pesticides in accordance with the EPA registration number of the re- standards prescribed by the EPA in 40 stricted use pesticide that was applied; CFR part 171. (2) The total amount of the restricted [58 FR 19022, Apr. 9, 1993, as amended at 60 use pesticide applied; FR 8123, Feb. 10, 1995] (3) The location of the application, designated as ‘‘spot application,’’ fol- § 110.3 Records, retention, and access lowed by a concise description of loca- to records. tion and treatment; and (a) Certified applicators of restricted (4) The month, day, and year on use pesticides shall maintain records of which the restricted use pesticide ap- the application of restricted use pes- plication occurred. ticides. Except as provided in para- (c) The information required in this graph (b) of this section, these records section shall be recorded within 14 days shall include the following information following the pesticide application. for each application: However, whether or not the written (1) The brand or product name, and record has been completed, the cer- the EPA registration number of the re- tified applicator shall provide the in- stricted use pesticide that was applied; formation to be recorded in accordance (2) The total amount of the restricted with § 110.5(a). use pesticide applied; (d) The records required in this sec- (3) The location of the application, tion shall be retained for a period of 2 the size of area treated, and the crop, years from the date of the restricted commodity, stored product, or site to use pesticide application and be main- which a restricted use pesticide was ap- tained in a manner that is accessible plied. The location of the application by authorized representatives.
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(e) A commercial applicator shall, dividual who may have been exposed to within 30 days of a restricted use pes- the restricted use pesticide for which ticide application, provide a copy of the record is or will be maintained, the records required under this section or certified applicator required to main- under State or Federal regulations tain the record shall promptly provide (whichever is applicable) under which the record information and any avail- the commercial applicator is holding able label information. If it is deter- certification, to the person for whom mined by the attending licensed health the restricted use pesticide was ap- care professional, or an individual act- plied. ing under the direction of the attend- (f) A certified applicator shall, upon ing licensed health care professional, oral request and presentation of cre- to be a medical emergency, the record dentials by an authorized representa- information of the restricted use pes- tive, make available to the authorized ticide, relating to the medical emer- representative the records required to gency, shall be provided immediately. be maintained under this section and (b)(1) The attending licensed health permit the authorized representative care professional, or an individual act- to copy any of the records. The original ing under the direction of the attend- of the records required to be main- ing licensed health care professional, tained under this section shall be re- may utilize and release the record or tained by the certified pesticide appli- record information obtained under cators. paragraph (a) of this section when nec- (g) No Federal or State agency shall essary to provide medical treatment or release information obtained under first aid to an individual who may have this part that would directly or indi- been exposed to the restricted use pes- rectly reveal the identity of producers ticide for which the record is or will be of commodities to which restricted use maintained. pesticides have been applied. (2) The attending licensed health care (h) Certified applicators who apply professional may release the record or restricted use pesticides in States record information to appropriate fed- where they are required to maintain eral or state agencies that deal with records on applications of restricted pesticide use or any health issue re- use pesticides, comparable to those for lated to the use of pesticides when nec- commercial applicators in that State, essary to prevent further injury or ill- and such records are maintained in ac- ness. cordance with State requirements, are (3) A licensed health care profes- not subject to paragraphs (a), (b), and sional may release the record or record (c) of this section. information to submit pesticide poi- [58 FR 19022, Apr. 9, 1993, as amended at 60 soning incident reports to appropriate FR 8123, Feb. 10, 1995] state or federal agencies. § 110.4 Demonstration of compliance. [60 FR 8123, Feb. 10, 1995] The Secretary is authorized to in- spect and copy any record required to § 110.6 Federal cooperation with States. be maintained by this part in order to determine whether a certified appli- (a) For the purpose of carrying out cator is complying with this part. this part, the Administrator may enter into agreements with States. § 110.5 Availability of records to facili- (b) The Administrator may, after en- tate medical treatment. tering a State-Federal cooperative (a) When the attending licensed agreement with a State, utilize em- health care professional, or an indi- ployees and facilities of the State to vidual acting under the direction of the carry out any provisions of this part in attending licensed health care profes- that State. This State-Federal coopera- sional, determines that any record of tive agreement shall specify: the application of any restricted use (1) The agency of the State that is pesticide required to be maintained designated as the State lead agency; under § 110.3 is necessary to provide (2) The responsibilities of State agen- medical treatment or first aid to an in- cies for the enforcement of this part
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and the imposition of penalties under penalty of not less than $1,000 for each this part; violation, except that the civil penalty (3) The qualifications required of the shall be less than $1,000 if the Adminis- State employees administering and en- trator determines that the certified ap- forcing this part; plicator made a good faith effort to (4) That the State-Federal coopera- comply with 7 U.S.C. 136i–1 (a) (b), and tive agreement may be terminated at (c) and this part. any time by the mutual agreement of [60 FR 8123, Feb. 10, 1995] the parties to the agreement; (5) That the State-Federal coopera- § 110.8 Rules of practice. tive agreement may be terminated by (a) Notice of violation. If there is rea- either party by giving written notice son to believe that a person has vio- to the other party at least 90 days be- lated or is violating any provision of fore a specified date of termination; this part, the complainant may file and with the Presiding Officer a notice of (6) The provisions for liaison between violation signed by the complainant. the State and the Administrator con- The notice of violation shall state: cerning the administration and en- (1) The date of issuance of the notice forcement of this part as may be of violation; agreed by the Administrator and the (2) The nature of the proceeding; State. (3) The identification of the com- (c) If at any time the Administrator plainant and respondent; shall determine that the State lead (4) The legal authority under which agency or other State agencies charged the proceeding is instituted; with carrying out the terms of the (5) The allegations of fact and provi- State-Federal cooperative agreement sions of law which constitute the basis are unable or unwilling to carry out for the proceeding; the terms of the agreement, or, if for (6) The amount of the proposed civil any reason the Administrator or State penalty; and shall determine that the agreement is (7) The name, mailing address, and no longer in effect, the Administrator telephone number of the Presiding Offi- shall administer and enforce this part cer. in the State. (b) Answer. Within 30 days after the (d) If a State shall notify the Admin- service of the notice of violation, the istrator of its readiness to enter into a respondent shall file with the Presiding State-Federal cooperative agreement Officer an answer signed by the re- prior to passage of State legislation spondent or by the attorney of record and regulations governing record- in the proceeding. The answer shall: keeping by certified applicators of re- (1) Admit, deny, or explain each of stricted use pesticides, the Adminis- the allegations in the notice of viola- trator may enter into a State-Federal tion and set forth any defense asserted cooperative agreement with the State by the respondent; or on an annual basis. (2) State that the respondent admits (e) For a State to be eligible for Fed- all the facts alleged in the notice of eral technical or financial assistance violation; or under a State-Federal cooperative (3) State that the respondent admits agreement, the State requirements for the jurisdictional allegations in the no- recordkeeping by all certified applica- tice of violation and neither admits nor tors of restricted use pesticides must denies the remaining allegations and be comparable to the recordkeeping re- consents to the issuance of an order quirements under this part. without further procedure. (c) Default. Failure to file an answer § 110.7 Penalties. within 30 days after service of the no- Any certified applicator who violates tice of violation shall be deemed, for 7 U.S.C. 136i–1 (a), (b), or (c) or this purposes of the proceeding, an admis- part shall be subject to a civil penalty sion of the allegations in the notice of of not more than $500 in the case of the violation, and failure to deny or other- first offense, and in the case of subse- wise respond to an allegation in the no- quent offenses, be subject to a civil tice of violation shall be deemed, for
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purposes of the proceeding, an admis- objections are not filed, the Presiding sion of the allegation, unless the com- Officer shall issue a decision without plainant and respondent have agreed to further procedure or hearing. Copies of a consent decision pursuant to para- the decision or denial of complainant’s graph (e) of this section. motion shall be served by the Presiding (d) Amendment of notice of violation or Officer upon the respondent and the answer. At any time prior to the filing complainant and may be appealed pur- of a motion for a hearing, the notice of suant to paragraph (l) of this section. violation or answer may be amended Where the decision as proposed by com- with the consent of the complainant plainant is entered, such decision shall and respondent or as authorized by the become final and effective without fur- Presiding Officer upon a showing of ther proceedings 35 days after the date good cause. of service of the decision upon the re- (e) Consent decision. At any time be- spondent, unless there is an appeal to fore the Presiding Officer files the deci- the Administrator by the complainant sion, the complainant and respondent or respondent, pursuant to paragraph may agree to the entry of a consent de- (l) of this section. cision. The agreement shall be in the (g) Conferences. (1) Upon motion of form of a decision signed by the com- the complainant or respondent, the plainant and respondent with appro- Presiding Officer may direct the com- priate space for signature by the Pre- plainant and respondent or their coun- siding Officer, and shall contain an ad- sel to attend a conference at any rea- mission of at least the jurisdictional sonable time, prior to or during the facts, consent to the issuance of the course of the hearing, when the Pre- agreed decision without further proce- siding Officer finds that the proceeding dure, and such other admissions or would be expedited by a conference. statements as may be agreed to by the Reasonable notice of the time and complainant and respondent. The Pre- place of the conference shall be given. siding Officer shall enter such decision The Presiding Officer may order the without further procedure, unless an complainant or respondent to furnish error is apparent on the face of the doc- at or subsequent to the conference any ument. The consent decision shall have or all of the following: the same force and effect as a decision (i) An outline of the case or defense; issued after a full hearing, shall be- (ii) The legal theories upon which the come final upon issuance, and shall be- party will rely; come effective in accordance with the (iii) A list of documents which the terms of the decision. party anticipates introducing at the (f) Procedure upon failure to file an an- hearing; and swer or admission of facts. The failure to (iv) A list of anticipated witnesses file an answer with the Presiding Offi- who will testify on behalf of the party. cer, or the admission by the answer of At the discretion of the party fur- all the material allegations of fact con- nishing such list of witnesses, the tained in the notice of violation, shall names of the witnesses need not be fur- constitute a waiver of hearing. Upon nished if they are otherwise identified such admission or failure to submit an in some meaningful way such as a answer, complainant shall file with the short statement of the type of evidence Presiding Officer a proposed decision, they will offer. along with a motion for the adoption of (2) The Presiding Officer shall not the proposed decision both of which order a party to furnish the informa- shall be served upon the respondent by tion or documents listed in paragraph the Presiding Officer. Within 20 days (g)(1) (i) through (iv) of this section if after service of the motion and pro- the party can show that providing the posed decision, the respondent may file particular information or document is with the Presiding Officer objections to inappropriate or unwarranted under the motion and proposed decision. If the circumstances of the particular the Presiding Officer finds that meri- case. torious objections have been filed, (3) At the conference, the following complainant’s motion shall be denied matters may be considered: with supporting reasons. If meritorious (i) The simplification of issues;
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(ii) The necessity of amendments to the Presiding Officer or upon the Pre- the notice of violation or answer; siding Officer’s own motion. (iii) The possibility of obtaining stip- (2) Time and place. If any material ulations of facts and of the authen- issue of fact is joined by the pleading, ticity, accuracy, and admissibility of the Presiding Officer, upon motion of documents, which will avoid unneces- any of the parties stating that the sary proof; matter is at issue and is ready for hear- (iv) The limitation of the number of ing, shall set a time and place for hear- expert or other witnesses; ing as soon as feasible with due regard (v) Negotiation, compromise, or set- for the public interest and the conven- tlement of issues; ience and necessity of the parties. The (vi) The exchange of copies of pro- Presiding Officer shall issue a notice posed exhibits; stating the time and place of hearing. (vii) The identification of documents If any change in the time or place of or matters of which official notice may the hearing is made, the Presiding Offi- be requested; cer shall issue a notice of this change, (viii) A schedule to be followed by the which notice shall be served upon the parties for completion of the actions complainant and respondent, unless it decided at the conference; and is made during the course of an oral (ix) Such other matters as may expe- hearing and made a part of the tran- dite and aid in the disposition of the script, or actual notice is given to the proceeding. parties. (4) A conference will not be steno- (3) Appearances. The parties may ap- graphically reported unless so directed pear in person or by attorney of record by the Presiding Officer. in the proceeding. Any individual who (5) In the event the Presiding Officer appears as an attorney must conform concludes that personal attendance by to the standard of ethical conduct re- the Presiding Officer and the parties or quired of practitioners before the counsel at a conference is unwarranted courts of the United States. or impractical, but determines that a (4) Debarment of attorney. Whenever a conference would expedite the pro- Presiding Officer finds that an indi- ceeding, the Presiding Officer may con- vidual acting as attorney for any party duct the conference by telephone or to the proceeding is guilty of unethical correspondence. or contumacious conduct, in or in con- (6) Actions taken as a result of a con- nection with a proceeding, the Pre- ference shall be reduced to a written siding Officer may order that the indi- appropriate order, unless the Presiding vidual be precluded from further acting Officer concludes that a stenographic as attorney in the proceeding. An ap- report shall suffice, or, the Presiding peal to the Administrator may be Officer elects to make a statement on taken from any such order, but no pro- the record at the hearing summarizing ceeding shall be delayed or suspended the actions taken. pending disposition of the appeal: Pro- (h) Procedure for hearing. (1) Request vided, That the Presiding Officer shall for hearing. The complainant or re- suspend the proceeding for a reasonable spondent may request a hearing on the time for the purpose of enabling the facts by including such a request in the party to obtain another attorney. notice of violation or answer, or by a (5) Failure to appear. A respondent separate request, in writing, filed with who, after being duly notified, fails to the Presiding Officer within the time appear at the hearing without good in which an answer may be filed. Fail- cause, shall be deemed to have waived ure to request a hearing within the the right to an oral hearing in the pro- time allowed for the filing of the an- ceeding and to have admitted any facts swer shall constitute a waiver of a which may be presented at the hearing. hearing. In the event the respondent The failure by the respondent to appear denies any material fact and fails to at the hearing shall also constitute an file a timely request for a hearing, the admission of all the material allega- matter may be set down for hearing on tions of fact contained in the notice of motion of the complainant filed with violation. The complainant shall have
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an election whether to follow the pro- shall be admissible in evidence without cedure set forth in paragraph (f) of this the production of the individual who section or whether to present evidence, made or prepared the same, and shall in whole or in part, in the form of affi- be prima facie evidence of the relevant davits, exhibits, or by oral testimony facts stated in the record or document. before the Presiding Officer. Failure to Such record or document shall be evi- appear at a hearing shall not be denced by an official publication of the deemed to be a waiver of the right to record or document or by a copy cer- be served with a copy of the Presiding tified by an individual having legal au- Officer’s decision and to appeal to the thority to make such certification. Administrator pursuant to paragraph (11) Official notice. Official notice (l) of this section. shall be taken of such matters as are (6) Order of proceeding. Except as may judicially noticed by the courts of the be determined otherwise by the Pre- United States and of any other matter siding Officer, the complainant shall of technical, scientific, or commercial proceed first at the hearing. fact of established character: Provided, (7) Evidence. (i) The testimony of wit- That the parties shall be given ade- nesses at a hearing shall be on oath or quate notice of matters so noticed, and affirmation and subject to cross-exam- shall be given adequate opportunity to ination. show that such facts are erroneously (ii) Upon a finding of good cause, the noticed. Presiding Officer may order that any (12) Offer of proof. Whenever evidence witness be examined separately and is excluded by the Presiding Officer, apart from all other witnesses except the party offering such evidence may those who are parties to the pro- make an offer of proof, which shall be ceeding. included in the transcript. The offer of (iii) Evidence which is immaterial, proof shall consist of a brief statement irrelevant, or unduly repetitious, or describing the evidence excluded. If the which is not of the sort upon which re- evidence consists of a brief oral state- sponsible persons are accustomed to ment, the statement shall be included rely, shall be excluded insofar as prac- in the transcript in its entirety. If the ticable. evidence consists of an exhibit, it shall (8) Objections. (i) If a party objects to be marked for identification and in- the admission of any evidence or to the serted in the hearing record. In either limitation of the scope of any examina- event, the evidence shall be considered tion or cross-examination or to any a part of the transcript and hearing other ruling of the Presiding Officer, record if the Administrator, upon ap- the party shall state briefly the peal, decides the Presiding Officer’s grounds of such objection, whereupon ruling excluding the evidence was erro- an automatic exception will follow if neous and prejudicial. If the Adminis- the objection is overruled by the Pre- trator, upon appeal, decides the Pre- siding Officer. siding Officer’s ruling excluding the (ii) Only objections made before the evidence was erroneous and prejudicial Presiding Officer may subsequently be and that it would be appropriate to relied upon in the proceeding. have such evidence considered a part of (9) Exhibits. Unless the Presiding Offi- the hearing record, the Administrator cer finds that the furnishing of copies may direct that the hearing be re- is impracticable, four copies of each ex- opened to permit the taking of such hibit shall be filed with the Presiding evidence or for any purpose in connec- Officer: Provided, That, where there are tion with the excluded evidence. more than two parties in the pro- (13) Transcript. Hearings shall be re- ceeding, an additional copy shall be corded and transcribed verbatim. filed for each additional party. A true (i) Post-hearing procedure—(1) Correc- copy of an exhibit may be substituted tions to transcript. (i) Within the period for the original. of time fixed by the Presiding Officer, (10) Official records or documents. An any party may file a motion proposing official government record or docu- corrections to the transcript. ment or entry in such a record or docu- (ii) Unless a party files a motion pro- ment, if admissible for any purpose, posing corrections to the transcript in
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the time fixed by the Presiding Officer, (i) requests for extensions of time the transcript shall be presumed, ex- pursuant to paragraph (m)(3) of this cept for obvious typographical errors, section; and to be a true, correct, and complete (ii) motions and requests made on the transcript of the testimony given at record during the oral hearing. The the hearing and to contain an accurate Presiding Officer shall rule upon all description or reference to all exhibits motions and requests filed or made received in evidence and made part of prior to the filing of an appeal of the the hearing record and shall be deemed Presiding Officer’s decision pursuant to to be certified without further action paragraph (l) of this section except mo- by the Presiding Officer. tions directly relating to the appeal. (iii) As soon as practicable after the Thereafter, the Administrator will rule close of the hearing and after consider- on any motions and requests, as well as ation of any timely objection filed as the motions directly relating to the ap- to the transcript, the Presiding Officer peal. shall issue an order making any correc- (2) Motions entertained. (i) Any mo- tions to the transcript which the Pre- tion will be entertained other than a siding Officer finds are warranted, motion to dismiss on the pleading. (A which corrections shall be entered on motion by the complainant seeking the to the original transcript by the Pre- voluntary dismissal of the notice of siding Officer without obscuring the violation may be entertained by the original text. Presiding Officer or the Adminis- (2) Proposed finding of fact, conclu- trator.) sions, order, and briefs. Prior to the Pre- (ii) All motions and requests con- siding Officer’s decision, each party cerning the notice of violation must be shall be afforded a reasonable oppor- made within the time allowed for filing tunity to submit for consideration pro- an answer, except motions by the com- posed findings of fact, conclusions, plainant seeking voluntary dismissal of order, and brief in support of the pro- the notice of violation. posed findings of fact, conclusions and (3) Contents. All written motions and order. A copy of each such document requests shall state the particular filed by a party shall be served upon order, ruling, or action desired and the each of the other parties. grounds for the order, ruling, or action (3) Presiding Officer’s decision. (i) The desired. Presiding Officer shall issue a decision (4) Response to motions and requests. within 30 days after the hearing, or, if Within 10 days after service of any any party submits proposed findings of written motion or request, or within a fact, conclusions, order, and a brief in shorter or longer period as may be support thereof in accordance with fixed by the Presiding Officer or the paragraph (i)(2) of this section, 30 days Administrator, an opposing party may after the last such submission. The file a response to the motion or re- Presiding Officer’s decision shall in- quest. The other party shall have no clude the Presiding Officer’s findings of right to reply to the response; however, the fact, conclusions of law, and the the Presiding Officer or the Adminis- reasons or basis for the findings of fact trator, in their discretion, may order and conclusions of law. that a reply be filed. (ii) The Presiding Officer’s decision (k) Presiding Officer—(1) Assignment. shall become effective without further No Presiding Officer shall be assigned proceedings 35 days after the date of to serve in any proceeding who: service of the decision upon the re- (i) Has any pecuniary interest in any spondent, unless there is an appeal to matter or business involved in the pro- the Administrator by a party to the ceeding; proceeding pursuant to paragraph (l) of (ii) Is related within the third degree this section. by blood or marriage to any party to (j) Motions and requests—(1) General. the proceeding; or All motions and requests shall be filed (iii) Has any conflict of interest with the Presiding Officer, and served which might impair the Presiding Offi- upon all the parties, except: cer’s objectivity in the proceeding.
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(2) Disqualification of Presiding Officer. guments on each issue, shall be sepa- (i) Any party to the proceeding may, rately numbered; shall be plainly and by motion made to the Presiding Offi- concisely stated; and shall contain de- cer, request that the Presiding Officer tailed citations of the record, statutes, withdraw from the proceeding because regulations, or authorities being relied of an alleged disqualifying reason. upon in support of the argument. A Such motion shall set forth with par- brief may be filed in support of the ap- ticularity the grounds of alleged dis- peal simultaneously with the appeal qualification. The Presiding Officer petition. may then either rule upon or certify (2) Response to appeal petition. Within the motion to the Administrator, but 20 days after the service of a copy of an not both. appeal petition and any brief in sup- (ii) A Presiding Officer shall with- port of the appeal petition, filed by a draw from any proceeding for any rea- party to the proceeding, any other son deemed by the Presiding Officer to party may file with the Administrator be disqualifying. a response in support of or in opposi- (3) Powers. The Presiding Officer, in tion to the appeal petition and, in such any assigned proceeding, shall have response any relevant issue, not pre- power to: sented in the appeal petition, may be (i) Rule upon motions and requests; raised. (ii) Set the time and place of a con- (3) Transmittal of record. Whenever an ference and the hearing, adjourn the appeal to the Presiding Officer’s deci- hearing from time to time, and change sion is filed and a response to the ap- the time and place of hearing; peal has been filed or time for filing a (iii) Administer oaths and affirma- response has expired, the Presiding Of- tions; ficer shall transmit to the Adminis- (iv) Summon and examine witnesses trator the record of the proceeding. and receive evidence at the hearing; The record shall include: the pleading; (v) Admit or exclude evidence; motions and requests filed and rulings (vi) Hear oral argument on facts or on such motions and requests; the tran- law; script of the testimony taken at the (vii) Do all acts and take all meas- hearing, together with the exhibits ures necessary for maintenance or filed in connection with the hearing; order, including the exclusion of con- any documents or papers filed in con- tumacious counsel or other persons; nection with a conference; such pro- and posed findings of fact, conclusions, and (viii) Take all other actions author- orders, and briefs in support thereof, as ized under this section. may have been filed in connection with (l) Appeal to the Administrator—(1) Fil- the proceeding; the Presiding Officer’s ing of petition. Within 30 days after re- decision; and such exceptions, state- ceiving notice of the Presiding Officer’s ments of objections and briefs in sup- decision, a party who disagrees with port thereof as may have been filed in the decision, or any part of the Pre- the proceeding. siding Officer’s decision, or any ruling (4) Decision of the Administrator on ap- by the Presiding Officer or a party who peal. As soon as practicable after the alleges a deprivation of rights, may ap- receipt of the record from the Pre- peal the Presiding Officer’s decision or siding Officer, the Administrator, upon rulings to the Administrator by filing the basis of and after due consideration an appeal petition with the Adminis- of the record and any matter of which trator. As provided in paragraph (h)(8) official notice is taken, shall rule on of this section, objections regarding the appeal. If the Administrator de- evidence or a limitation regarding ex- cides that no change or modification of amination or cross examination or the Presiding Officer’s decision is war- other ruling made before the Presiding ranted, the Administrator may adopt Officer may be relied upon in an ap- the Presiding Officer’s decision as the peal. The appeal petition shall state final order in the proceeding, pre- the name and address of the person fil- serving any right of the party bringing ing the appeal petition. Each issue set the appeal to seek judicial review of forth in the appeal petition, and the ar- such decision in the proper forum.
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(m) Filing; service; extensions of time; matter by regular mail. Any certificate and computation of time—(1) Filing; num- or post-office receipt returned to the ber of copies. Except as otherwise pro- Presiding Officer or Administrator vided in this section, all documents or shall be filed by the Presiding Officer papers required or authorized by this or Administrator, and made a part of section to be filed with the Presiding the record of the proceeding. Officer or Administrator shall be filed (3) Extensions of time. The time for the in quadruplicate: Provided, That where filing of any document or paper re- there are more than two parties in the quired or authorized under this section proceeding, an additional copy shall be to be filed may be extended by the Pre- filed for each additional party. siding Officer or the Administrator as (2) Service; proof of service. Copies of provided in paragraph (j) of this sec- all documents or papers required or au- tion, if in the judgment of the Pre- thorized by this section to be filed with siding Officer or the Administrator, as the Presiding Officer or Administrator the case may be, there is good reason shall be served upon the parties by the for the extension. In all instances in person with whom such documents or which time permits, notice of the re- papers are filed. Service shall be made quest for extension of the time shall be either: given to the other party with oppor- (i) By delivering a copy of the docu- tunity to submit views concerning the ment or paper to the individual to be request. served or to a member of the partner- (4) Effective date of filing. Any docu- ship to be served, or to the president, ment or paper required or authorized secretary, or other executive officer or under this section to be filed shall be any director of the corporation or asso- deemed to be filed at the time when it ciation to be served, or to the attorney reaches the person with whom the doc- of record representing such person; or ument or paper must be filed. (ii) By leaving a copy of the docu- (5) Computation of time. Saturdays, ment or paper at the principal office or Sundays, and holidays shall be in- place of business or residence of such individual, partnership, corporation, cluded in computing the time allowed organization, or association, or of the for the filing of any document or paper: attorney of record representing such Provided, That, when such time expires person and mailing by regular mail an- on a Saturday, Sunday, or holiday, other copy to such person at such ad- such period shall be extended to in- dress; or clude the next following business day. (iii) By registering or certifying and (n) Ex parte communications. (1) At no mailing a copy of the document or stage of the proceeding between its in- paper, addressed to such individual, stitution and the issuance of the final partnership, corporation, organization, decision shall the Presiding Officer or or association, or to the attorney of Administrator discuss ex parte the record representing such person, at the merits of the proceeding with any per- last known residence or principal office son who is connected with the pro- or place of business of such person: Pro- ceeding in an advocative or in an inves- vided, That if the registered or certified tigative capacity, or with any rep- document or paper is returned undeliv- resentative of such person: Provided, ered because the addressee refused or That the Presiding Officer or Adminis- failed to accept delivery, the document trator may discuss the merits of the or paper shall be served by remailing it case with such a person if all parties to by regular mail. Proof of service under the proceeding, or their attorneys have this paragraph shall be made by the been given notice and an opportunity certificate of the person who actually to participate. A memorandum of such made the service: Provided, That if the discussion shall be included in the service be made by mail, under para- record. graph (m)(2)(iii) of this section, proof (2) No interested person shall make of service shall be made by the return or knowingly cause to be made to the post-office receipt, in the case of reg- Presiding Officer or Administrator an istered or certified mail, or by the cer- ex parte communication relevant to tificate of the person who mailed the the merits of the proceeding.
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(3) If the Presiding Officer of the Ad- able prior notice to all parties is not ministrator receives an ex parte com- given, but it shall not include requests munication in violation of this para- for status reports on any matter or the graph (n), the individual who receives proceeding. the communication shall place in the public record of the proceeding: § 110.9 Miscellaneous. (i) Any such written communication; In accordance with Section 3507 of (ii) Memoranda stating the substance the Paperwork Reduction Act of 1980 of such oral communication; and (44 U.S.C. 3507), the recordkeeping pro- (iii) Any written response, and memoranda stating the substance of visions in this rule have been approved any oral response to the ex parte com- by the Office of Management and Budg- munication. et (OMB) and there are no new require- (4) For purposes of this section ex ments. The assigned OMB control num- parte communication means an oral or ber is 0581–AA39. written communication not on the pub- lic record with respect to which reason- PARTS 111–159 [RESERVED]
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PART 160—REGULATIONS AND 160.39 Form of application for license or permit. STANDARDS FOR NAVAL STORES 160.40 Applicant for license to be examined. 160.41 Issuance of temporary license. GENERAL 160.42 Limitation of license. Sec. 160.43 Licensed inspector to be disin- 160.1 Definitions of general terms. terested. 160.2 Spirits of turpentine defined. 160.44 Other duties of licensed inspectors. 160.3 Rosin defined. 160.45 Conditions governing licensed inspec- 160.4 Reclaimed rosin. tion. 160.5 Standards for naval stores. 160.46 Identification of containers. 160.6 Standard designations for turpentine. 160.47 Periodic re-inspection. 160.7 Gum spirits of turpentine. 160.48 Form of certificate. 160.8 Steam distilled wood turpentine. 160.49 Responsibility for inspection certifi- 160.9 Destructively distilled wood turpen- cates and forms. tine. 160.50 Reports to be made by accredited 160.10 Sulphate wood turpentine. processors. 160.11 Quality requirements. 160.51 Report of non-conformance. 160.12 Standard designations for rosin. 160.52 Suspension or revocation of licenses. 160.13 Grade designations for rosin. 160.53 Stopping inspection by suspended in- 160.14 Opaque rosin. spector. 160.54 Suspension or revocation of permits. ESTABLISHMENT OF NEW AND MODIFIED 160.55 Voluntary discontinuance of licensed STANDARDS inspection. 160.15 New standards. 160.56 Compensation of licensed inspectors. 160.16 Modification of existing standards. 160.57 Fees for licensed inspection permits. 160.58 Fees for inspection and certification METHODS OF ANALYSIS, INSPECTION, SAMPLING by licensed inspectors. AND GRADING 160.59 Appeal inspections. 160.60 Charge for appeal inspection. 160.17 Laboratory analysis. 160.18 Determining the grade of rosin. CERTIFICATES AND REPORTS 160.19 Samples of rosin for grading. 160.20 More than one grade in a container. 160.61 Kinds of certificates issued. 160.21 Rosin not fit for grading. 160.62 When a certificate may be issued. 160.22 Collecting samples; issuing certifi- 160.63 When a certificate may not be issued. cates. 160.64 Issuance of loan and sale certificate. 160.23 Disposition of samples. 160.65 Prior certification required.
ANALYSIS, INSPECTION, AND GRADING ON FEES AND CHARGES FOR SERVICES RENDERED REQUEST 160.66 Fees for inspection services. 160.24 Inspection on request. 160.67 Fees under cooperative agreements. 160.24a Inspection as to condition of drums 160.68 Collection of fees. containing rosin and the quality and con- 160.69 Expenses to be borne by person re- dition of the rosin therein upon request. questing service. 160.25 How requests shall be made. 160.70 Rendition of claims. 160.26 Withdrawal of request. 160.71 Delinquent claims. 160.27 Containers to be made ready. 160.28 Tank cars of turpentine. LOAN AND CARE OF UNITED STATES 160.29 Containers to remain intact. STANDARDS 160.30 Contents of containers to be des- 160.73 Availability of standards. ignated. 160.74 Loan of standards without security. 160.31 Time and manner of sampling. 160.75 Loan of standards under security de- 160.32 Marking containers. posit. 160.33 Containers not acceptable for inspec- 160.76 Annual charge for use of standards. tion. 160.77 Reporting on use of standards. 160.34 Responsibility of interested person. 160.78 Loss or damage of standards. 160.35 Illegible inspection marks. 160.79 Request for additional standards. 160.36 Authority for changing marks. 160.80 Denial of loan of additional stand- 160.37 Prior marks to be removed. ards. 160.81 Surrender of standards. REQUEST INSPECTION BY LICENSED INSPECTORS 160.82 Return of security. 160.38 Permit to use licensed inspector. 160.83 Miscellaneous receipts.
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SALES AND SHIPMENTS of the Department, or any officer or 160.84 Identification of shipments. employee of the Department to whom 160.85 Sale of mixed turpentine not lawful. authority has heretofore been dele- 160.86 Prohibited use of United States gated, or to whom authority may here- Standards. after be delegated, to act in his stead. 160.87 Prohibited use of word ‘‘turpentine’’ or derivatives thereof. (d) Official inspector: Any person des- 160.88 Permitted use of words ‘‘turpentine’’ ignated or licensed by the Secretary to and ‘‘rosin.’’ sample, examine, analyze, classify or 160.89 Medicinal preparations. grade naval stores.
LABELING, ADVERTISING AND PACKING (e) Licensed inspector: A person li- censed by the Administrator upon rec- 160.90 False, misleading, or deceitful prac- tices. ommendation of an accredited proc- 160.91 Meaning of words ‘‘pine’’ and ‘‘pine essor to act as an official inspector tree.’’ with respect to naval stores produced 160.92 Meaning of word ‘‘gallon.’’ at an eligible processing plant of such 160.93 Powdered rosin. processor. 160.94 Spirits of turpentine for medicinal use. (f) Eligible processing plant: A plant which on examination by the Adminis- PROCEEDINGS IN CASE OF VIOLATION trator has been found to be designed, 160.95 Proceedings prior to reporting viola- operated, and staffed so as to permit tions of the act. proper samplings and inspections of the 160.96 Report of violations for prosecution. naval stores produced thereat, and 160.97 Publication. where a substantial proportion of the SPECIFIC FEES PAYABLE FOR SERVICES output comes from oleoresin obtained RENDERED from trees growing on land not owned 160.201 Fees generally for field inspection or leased by the processor himself, or and certification of naval stores and from oleoresin contained within felled drum containers of rosin. trees or stumps removed from such 160.202 Fees generally for laboratory anal- land. ysis and testing. 160.203 Fees for inspection and certification (g) Accredited processor: Any person of other naval stores material. owning or having charge of or jurisdic- 160.204 Fees for extra cost and hourly rate tion over the operation of an eligible service. processing plant, to whom a permit has 160.205 Permit fees for eligible processing been issued under these regulations to plants under licensed inspection. have inspections of naval stores made AUTHORITY: 7 U.S.C. 94, 1624. by a licensed inspector. SOURCE: 11 FR 14665, Dec. 27, 1946, as (h) Interested person: Any person who amended at 17 FR 221, Jan. 9, 1952; 20 FR 6433, is a party to a factual or prospective Sept. 1, 1955, unless otherwise noted. transaction in a specific lot of naval stores, whether as producer, seller, GENERAL shipper, dealer, or purchaser thereof; or § 160.1 Definitions of general terms. any person who in the opinion of the The terms as defined in section 2 of Administrator has sufficient and prop- the Naval Stores Act shall apply with er interest in the analysis, classifica- equal force and effect when used in the tion, grading, or sale of naval stores to provisions in this part. In addition, un- merit the loan and use of duplicates of less the context requires otherwise, the the United States Standards. terms hereinafter set forth shall be de- (i) Dealer: Any person who sells or fined respectively as follows: ships in commerce any naval stores (a) Act: The Naval Stores Act of produced by a person other than him- March 3, 1923 (42 Stat. 1435; 7 U.S.C. 91– self. 99). (j) Cooperative agreement: A written (b) Department: The United States De- agreement between the Department partment of Agriculture. and any person specifying the condi- (c) Administrator: The Administrator tions under which special inspection of the Agricultural Marketing Service
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personnel may be designated and proce- living trees of the family Pinaceae, or dures established, not otherwise avail- present in the cellular structure, or able under existing inspection pro- wood, of species thereof. grams, in order to make possible a con- tinuous, day-by-day inspection of naval § 160.3 Rosin defined. stores for such person, or to provide fa- Except as provided in § 160.15, rosin is cilities for carrying out experimental the vitreous, well-strained, trans- studies on authentic naval stores re- parent, solid resin which (a) remains lated to the inspection and marketing after the volatile terpene oils are dis- thereof. tilled from (1) the oleoresin collected (k) Standards: The official Naval from living trees or (2) the oleoresin Stores Standards of the United States extracted from wood; or (b) remains for classification and grading of spirits after distillation of the fatty acids of turpentine and rosin. from tall oil recovered from wood in (l) Analysis: Any examination by the course of its chemical disintegra- physical, chemical, or sensory meth- tion to produce cellulose. In addition ods. to the free resin acids, rosin may con- (m) Classification: Designation as to tain relatively small proportions of kind of spirits of turpentine or rosin. fatty acids, resin esters and other (n) Grading: Determination of the esters, unsaponifiable resenes, and non- grade of turpentine or rosin by com- resinous foreign matter naturally oc- parison with the standards. curring therein. (o) Certificate: The official certificate issued under the provisions of the act § 160.4 Reclaimed rosin. and the provisions in this part to show Reclaimed rosin is rosin that has the results of any examination, anal- been recovered or reclaimed by any ysis, classification, or grading of naval means from waste or deteriorated ma- stores by an official inspector. terial: Provided, That such reclaimed (p) Label: Any word, combination of product may be graded as rosin under words, coined or trade name, the act and the provisions in this part picturization of any natural scene or only if the concentration of rosin acids article, or any limitation thereof, ap- therein has not been reduced below the plied to, superimposed upon, impressed concentration normal for rosin, and into, or in any other manner attached any residual or contaminating compo- to a container of naval stores or other nent remaining from the waste mate- article coming within the scope of the rial itself or from any article used in act, by which the nature, kind, quality, the recovery process is not sufficient to or quantity of the contents of such cause the physical or chemical prop- container may be indicated. erties of the reclaimed product to dif- (q) Container: Any receptacle in fer substantially from the normal prop- which naval stores are placed for in- erties of rosin. spection or distribution in commerce; includes barrel, drum, tank, tank car, § 160.5 Standards for naval stores. bag, bottle, can, or other receptacle. In addition to the standards of iden- [11 FR 14665, Dec. 27, 1946, as amended at 17 tity for spirits of turpentine and rosin FR 221, Jan. 9, 1952; 20 FR 6433, Sept. 1, 1955; and the grade designations for rosin 46 FR 47055, Sept. 24, 1981; 47 FR 3344, Jan. 25, specified in the act, certain standards 1982] for naval stores have been promulgated by the Administrator pursuant to the § 160.2 Spirits of turpentine defined. act as indicated in § 160.301 et seq. Spirits of turpentine, also commonly known as turpentine, is the colorless or § 160.6 Standard designations for tur- faintly colored volatile oil consisting pentine. principally of terpene hydrocarbons of Spirits of turpentine within the the general empirical formula C10 H16 meaning of the act and the provisions and having a characteristic odor and in this part shall be designated as taste. It occurs naturally in and may ‘‘gum spirits of turpentine,’’ ‘‘steam be recovered by distillation from the distilled wood turpentine,’’ ‘‘destruc- oleoresinous secretions obtained from tively distilled wood turpentine,’’ or
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‘‘sulphate wood turpentine,’’ as the § 160.12 Standard designations for case may be. rosin. § 160.7 Gum spirits of turpentine. (a) Rosin within the meaning of the act and the provisions in this part shall The designation ‘‘gum spirits of tur- be designated as ‘‘gum rosin,’’ ‘‘wood pentine’’ shall refer to the kind of spir- rosin,’’ or ‘‘tall oil rosin,’’ as the case its of turpentine obtained by distilla- may be. tion of the oleoresin (gum) from living trees, and commonly known prior to (b) The designation ‘‘gum rosin’’ the passage of the act as gum spirits, shall refer to the kind of rosin remain- gum turpentine, spirits of turpentine, ing after the distillation of gum spirits or oil of turpentine. of turpentine from the oleoresin (gum) obtained from living pine trees. § 160.8 Steam distilled wood turpen- (c) The designation ‘‘wood rosin’’ tine. shall refer to the kind of rosin recov- The designation ‘‘steam distilled ered after the distillation of the vola- wood turpentine’’ shall refer to the tile oil from the oleoresin within or ex- kind of spirits of turpentine obtained tracted from pine wood by any suitable by steam distillation from the process, followed by any necessary fur- oleoresinous component of wood ther refinement. whether in the presence of the wood or (d) The designation ‘‘tall oil rosin’’ after extraction from the wood, and shall refer to the kind of rosin remain- commonly known prior to the passage ing after the removal of the fatty acids of the act as wood turpentine, steam from tall oil by fractional distillation, distilled turpentine, steam distilled and having the characteristic form and wood turpentine, or S. D. wood turpen- appearance and other physical and tine. chemical properties normal for other kinds of rosin. § 160.9 Destructively distilled wood turpentine. § 160.13 Grade designations for rosin. The designation ‘‘destructively dis- The grades of rosin shall be des- tilled wood turpentine’’ shall refer to ignated, from highest to lowest, by the the kind of spirits of turpentine pre- following letters, respectively: XC, XB, pared from the distillate obtained in XA, X, WW, WG, N, M, K, I, H, G, F, E, the destructive distillation (carbon- D, B. In addition, the letters OP shall ization) of wood, and commonly known be used to designate the grade of prior to the passage of the act as de- opaque rosin, and the letters FF shall structively distilled wood turpentine or be used to designate the grade of nor- D.D. wood turpentine. mal wood rosin: Provided, That the § 160.10 Sulphate wood turpentine. product recovered in the refining of wood rosin, that is darker in color than The designation ‘‘sulphate wood tur- the standard for FF grade, and that pentine’’ shall refer to the kind of spir- contains rosin acids in lesser quantity its of turpentine prepared from the than is normal for such rosin, shall be condensates that are recovered in the graded and designated as B wood resin. sulphate process of cooking wood pulp, and commonly known as sulphate tur- [11 FR 14665, Dec. 27, 1946, as amended at 17 pentine or sulphate wood turpentine. FR 221, Jan. 9, 1952; 33 FR 8722, June 14, 1968]
§ 160.11 Quality requirements. § 160.14 Opaque rosin. The several standards for spirits of The term ‘‘opaque rosin’’ shall apply turpentine, as defined in §§ 160.8 to to the article resulting when rosin un- 160.10, inclusive, shall be deemed to dergoes internal modification indicated mean the respective kinds of spirits of by a turbid, clouded, or opaque appear- turpentine having properties that con- ance, that is, loss of transparency, form with the standard specifications brought about by the occlusion of adopted therefor by the American Soci- moisture or the formation of an exces- ety for Testing Materials, contained in sive quantity of resin acid crystals in appendix A to this part. the rosin.
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ESTABLISHMENT OF NEW AND MODIFIED thereof, and a recommendation as to STANDARDS adoption or rejection of the proposed modification shall be transmitted to § 160.15 New standards. the Administrator for his consider- Whenever in the opinion of the Ad- ation. A modified standard established ministrator a new standard for any and promulgated by the Administrator naval stores is necessary in the inter- shall become effective not less than 6 est of the trade, he shall announce a months after the promulgation thereof. hearing thereon, to be held not less than 3 months subsequent to such an- METHODS OF ANALYSIS, INSPECTION, nouncement. Notice of the hearing SAMPLING AND GRADING stating the terms or description of the proposed new standard, or a summary § 160.17 Laboratory analysis. thereof, shall be given by publication The analysis and laboratory testing in the FEDERAL REGISTER and by such of naval stores shall be conducted, so other means as may be practicable. far as is practicable, according to The hearing shall be conducted by an methods of the American Society for official designated by the Adminis- Testing Materials. When any such trator, and reasonable opportunity method is deemed to be insufficient or shall be afforded at the hearing to all unsuitable or when no method has been interested persons to present their so presented, the analysis shall be views, arguments and data, verbally or made according to any method deemed in writing, in favor of or in opposition appropriate by the Administrator. to the proposed new standard. All rel- evant material presented at said hear- § 160.18 Determining the grade of ing, or a summary thereof, and a rec- rosin. ommendation as to adoption or rejec- The grade of rosin shall be deter- tion of the proposed new standard shall mined by comparing a representative be transmitted to the Administrator sample, taken and prepared in accord- for his consideration. A new standard ance with the provisions in this part, established and promulgated by the with the appropriate standard types. Administrator shall become effective The grade shall be the grade designa- not less than 3 months after the pro- tion of the standard type which the mulgation thereof. sample equals or excels in color, but below the next higher grade. § 160.16 Modification of existing stand- ards. § 160.19 Samples of rosin for grading. Whenever in the opinion of the Ad- Samples of rosin for grading shall be ministrator a modification of an exist- approximately cubical in shape, and ing standard for naval stores is nec- shall be seven-eighths inch thick in the essary in the interest of the trade, he direction through which they are shall announce a hearing thereon, to be viewed or graded. Samples may be held not less than 6 months subsequent taken by any of the following methods: to such announcement. Notice of the (a) By cutting or cleaving the same hearing stating the terms or descrip- from a lump of the rosin removed from tion of the proposed modification of the solid mass in the barrel or drum, any standard, or a summary thereof, the top side of which lump shall come shall be given by publication in the from not less than 4 inches below the FEDERAL REGISTER and by such other surface of the rosin. means as may be practicable. The hear- (b) By placing a tin mold of suitable ing shall be conducted by an official design inside the barrel or drum designated by the Administrator, and through an opening in the side, the reasonable opportunity shall be af- center of which opening is approxi- forded to all interested persons to mately 9 inches from the top or 12 present their views, arguments and inches from the bottom so that when data, verbally or in writing, in favor of the container is filled, the rosin within or in opposition to the proposed modi- the mold will have come from a posi- fication. All relevant material pre- tion not less than 4 inches below the sented at said hearing, or a summary surface of the rosin. The mold thus
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placed must be entirely within the bar- only when the sampling is performed rel or drum and completely encased in by an official inspector. the rosin. (c) By suspending in the barrel or § 160.20 More than one grade in a con- drum of molten rosin a clean tinplate tainer. mold, 7⁄8 inch square (inside) and 11⁄2 When a sample from the bottom of a inches or more in length, in such a barrel or drum shows not more than manner that it will be in a horizontal one grade lower than that of a top sam- position at least 2 inches below the sur- ple taken in accordance with § 160.19, face of the rosin after it has thor- the grade of the rosin shall be that of oughly cooled. Such sample shall not such top sample: Provided, That if such be spiked from the barrel or drum until ‘‘bottom head’’ sample shows more it is completely cooled. than one grade lower than the top sam- (d) By withdrawing a quantity of ple, the grade assigned to the rosin molten rosin from a full container of shall be that of the darkest or lowest 150 pounds content or less, pouring the grade of rosin in the container. rosin into a suitable mold, and allow- ing it to cool and solidify slowly: Pro- § 160.21 Rosin not fit for grading. vided, That samples taken to represent An article consisting of rosin with an a single batch or charge made by inter- excessive amount of trash or other visi- mittent distillation of oleoresin shall ble extraneous foreign material, or an be taken from not less than two con- article that is of such color or appear- tainers, one of which shall be selected ance as not to permit its accurate clas- when one fourth of the batch has been sification and grading in accordance placed in the containers, and the other with the standards provided for rosin, shall be from the last container filled. shall not be classified, graded, marked, (e) By withdrawing a quantity of sold, or offered for sale in commerce as molten rosin from a full drum that has rosin. been filled after a preliminary cooling period, pouring the rosin into a suit- § 160.22 Collecting samples; issuing able mold, and allowing it to cool and certificates. solidify slowly: Provided, That such The collection of official samples for sample shall not be taken until at least the purpose of putting into effect any one hour has elapsed after the drum of the provisions of the act, and the was filled: And provided further, That issuance of certificates reporting the the selection of drums to be sampled results of any analysis, classification, shall be in accordance with the method or grading shall be limited to official of selecting small containers as set inspectors and to such other personnel forth in paragraph (d) of this section. of the Department as may be author- Rosin in drums sampled in this manner ized. will be graded and certified only when the sampling is performed by an offi- § 160.23 Disposition of samples. cial inspector. Rosin in open head bar- All samples taken by an official in- rels shall not be sampled by this meth- spector or submitted by an interested od. person shall become and remain the (f) By collecting in a suitable vessel a property of the Department, to be dis- quantity of molten rosin from each posed of as the Administrator may de- successive batch or charge as it is de- termine. livered into a tank car, pouring the re- spective quantities of rosin into suit- ANALYSIS, INSPECTION, AND GRADING ON able molds, and allowing them to cool REQUEST and solidify: Provided, That any dark- ening of the rosin subsequent to such § 160.24 Inspection on request. sampling will not be recognized as af- Insofar as it may be practicable, offi- fecting the correctness of the grades cial inspectors shall sample, analyze, assigned to the rosin at the time it was classify, or grade any naval stores at loaded in the car. Rosin so sampled the request of any interested person, as while in process of being placed in a provided for by the act and in accord- tank car will be graded and certified ance with the provisions in this part.
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§ 160.24a Inspection as to condition of § 160.26 Withdrawal of request. drums containing rosin and the quality and condition of the rosin A request for service under the provi- therein upon request. sions in this part may be withdrawn at Before or after the shipment in com- any time before the service has been merce of any lot of rosin in drums from completed, on notice to the official in- a processing or storage point, and upon spector: Provided, however, That the in- request by an interested person, an in- terested person shall reimburse the spection may be made by an official in- United States for the time spent and spector of the external appearance of any expenses incurred prior to receipt the drums, and a report may be made of such withdrawal notice. by such inspector, on the basis of such inspection, of the condition, including § 160.27 Containers to be made ready. soundness, of the drums with reference The interested person shall cause the to the effect thereof upon the quality, naval stores to be made available, and and preservation of the quality, of the shall provide any held required to re- rosin in the drums. In conjunction with move the bungs or heads, or otherwise such service, when practicable, the in- open the containers for sampling, to spector may upon similar request de- spike the rosin or extract the sampler termine and certify the grade, class, devices from the barrels or drums, to other quality, or condition of the rosin rebung or otherwise close the con- within the drums, and report the inter- tainers, to handle the commodity for nal condition of the drums, under any applicable standards and procedural in- weighing, and to mark the containers structions issued to such inspector by at the direction of the official inspec- the Administrator. Certificates and re- tor. ports issued under this section will be furnished only to the interested person § 160.28 Tank cars of turpentine. requesting the service. Fees and A tank car loaded for shipment with charges for service under this section spirits of turpentine shall, after the shall be paid by such interested person same has been sampled for analysis, in accordance with §§ 160.201, 160.202, classification, and certification, be and 160.204. sealed by the official inspector. Any [20 FR 6433, Sept. 1, 1955] certificate issued thereon prior to ship- ment shall be valid only for a reason- § 160.25 How requests shall be made. able time to permit arrival at destina- An interested person desiring the tion, and only so long as the seals analysis, classification, or grading of placed thereon by the inspector remain any naval stores, or of samples thereof, unbroken. shall submit to the nearest official in- spector a written request, in which he § 160.29 Containers to remain intact. shall state the number and kind of con- The results of any analysis, classi- tainers of rosin, or the number and fication, or grading of naval stores will kind of containers and the number of be certifiable only if the containers gallons of turpentine, as the case may holding such naval stores remain in- be, together with the name of the in- tact as sampled until the analysis, terested person for whose account such classification, or grading has been service is requested, his interest in the completed and the results reported, ex- naval stores, and other information by cept when the container is a tank car which the identity of the naval stores in question and the propriety of its ex- subject to demurrage. amination may be determined. Re- § 160.30 Contents of containers to be quests for seasonal or recurrent serv- designated. ices shall so indicate, and the approxi- mate quantity of naval stores to be Prior to inspection at the request of graded and the duration of the desired the producer, containers of naval service shall be stated. Fees for such stores, other than tank cars, shall have service shall be paid in accordance marked thereon a designation by such with the provisions in this part. producer of the kind or identity of the
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product in accordance with the stand- § 160.35 Illegible inspection marks. ard of identity provided therefor by or under the act. In case any mark placed on a con- tainer of rosin by or under the direc- § 160.31 Time and manner of sampling. tion of an official inspector has become Except when batch sampling is au- illegible, he will make such examina- thorized at an eligible processing plant tion before remarking as may be nec- using licensed inspectors, samples of essary to establish the proper grade or naval stores to be used for official in- identity of the rosin. No fee will be spection and certification shall be charged for this service, but the cost of taken direct from the commercial con- handling, opening, spiking, and closing tainers holding such naval stores by or the container shall be borne by the in- under the immediate supervision of the terested person. inspector at the time of inspection. § 160.36 Authority for changing marks. § 160.32 Marking containers. No mark placed upon any container The interested person shall provide of naval stores by or at the direction of any labor necessary for marking the an official inspector shall be obliter- containers, after the contents have ated, covered up, defaced, or otherwise been sampled and graded, at the direc- made illegible, except under authority tion of the official inspector. The con- of an official inspector. tainer of an article which does not con- form with any United States Standard § 160.37 Prior marks to be removed. for naval stores as to kind or grade, Any marking appearing on a con- shall not be marked or certified, and tainer to be used for naval stores, re- any unauthorized marks appearing on lating to the kind, classification, the container shall be removed. grade, certification, or method of in- § 160.33 Containers not acceptable for spection of naval stores shall be re- inspection. moved by the user whenever such marking does not in all respects de- Any container so filled or packed as scribe the kind, classification, grade, to conceal the fact that it contains certification, and method of inspection anything other than naval stores with- of the naval stores to be placed therein. in the meaning of the act or the provi- sions in this part, and any naval stores REQUEST INSPECTION BY LICENSED in a container deemed by an official in- INSPECTORS spector to be unsuitable for use as a container of naval stores in commerce, § 160.38 Permit to use licensed inspec- shall not be accepted for classification tor. or grading. Any naval stores produced at an eli- § 160.34 Responsibility of interested gible processing plant, as herein de- person. fined, may be inspected, classified, The sampling or acceptance of any graded, and certified by a licensed in- sample of naval stores by an official in- spector, after the accredited processor spector for use in grading and certi- has applied to and has been granted a fying the same at the request of an in- permit by the Administrator to use a terested person, or the placing of any licensed inspector. incorrect classification or grade marks upon the container thereof, or the issue § 160.39 Form of application for li- cense or permit. of any incorrect certificate inadvert- ently to cover the contents, because of Applications for licenses to inspect inability of the inspector to observe and permits to have inspections made the true condition of the naval stores, by licensed inspectors shall be made to shall not prevent the correction or re- the Administrator upon forms provided call of any such certificate, nor relieve for the purposes. Each such application the interested person from responsi- shall fully and truly state the informa- bility for the condition of the article or tion therein required and shall be its container. signed by the applicant.
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§ 160.40 Applicant for license to be ex- trator: Provided, That such additional amined. duties not pertaining to the official in- Each applicant for a license shall be spection work shall not be permitted to required to demonstrate his qualifica- interfere with the proper performance tions and competency to perform the of the duties of the licensee as an offi- duties of an official inspector at such cial inspector. time and place and in such manner as § 160.45 Conditions governing licensed may be determined by the Adminis- inspection. trator. The work performed by licensed in- § 160.41 Issuance of temporary license. spectors under the provisions in this In a case of special urgency, and in part shall be supervised and reviewed the discretion of the Administrator, a by authorized representatives of the temporary license may be issued with- Administrator, who shall issue to such out reference to § 160.40 upon presen- licensed inspectors instructions for tation of satisfactory evidence by the taking, preserving, and identifying accredited processor of the need there- samples; marking and maintaining the for and the competency of the appli- identity of containers when filled; pre- cant for such temporary license. Such paring, issuing, and disposing of certifi- processor shall receive prompt notice cates; the keeping of adequate inspec- of the issuance of any such temporary tion records; and such other procedures license. A temporary licensee shall be as may be necessary in carrying out subject to all the provisions in this the licensed inspection. The handling, part. A temporary license shall be valid sampling, grading, marking, and cer- for a specified period not to exceed 30 tification of naval stores at an eligible days, except that if application is made processing plant by a licensed inspec- for a permanent license by a person at tor shall be conducted in accordance the same time he applies for a tem- with such instructions and the provi- porary license, any temporary license sions in this part. issued to him shall not expire until a § 160.46 Identification of containers. permanent license has been denied or granted. Containers packed with naval stores which have been inspected, classified, § 160.42 Limitation of license. graded, and certified by a licensed in- The license issued by the Adminis- spector at an eligible processing plant trator to a licensed inspector of naval shall be marked to show the name and stores shall state the name of the proc- location or other acceptable identifica- essing plant or plants at which the li- tion of the plant, and the legend ‘‘U.S. censee may perform the duties of an of- Graded’’ or ‘‘U.S. Inspected’’, and, in ficial inspector, and shall be the case of rosin, the batch number in- countersigned by such official as may dicating the date of production. be designated and authorized. § 160.47 Periodic re-inspection. § 160.43 Licensed inspector to be disin- Any eligible processing plant may terested. from time to time be re-inspected and No person who determines or con- any rosin produced by such plant may trols sales policies or methods of dis- be graded or re-graded by any official tribution of an eligible processing inspector authorized to make such ex- plant, or the selling prices of the naval aminations. The results of such exami- stores processed at such plant, shall be nations shall be made known only to licensed as an inspector. the affected processor, the licensed in- spector, and to such employees of the § 160.44 Other duties of licensed in- Department officially authorized to re- spectors. ceive such information. A licensed inspector may perform du- ties other than those of an official in- § 160.48 Form of certificate. spector, to the extent indicated by the The certificates issued under this accredited processor and not dis- part by licensed inspectors shall be on approved in writing by the Adminis- forms approved by the Administrator.
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§ 160.49 Responsibility for inspection sions in this part. A license may be certificates and forms. suspended for similar failures, condi- Certificate forms and other inspec- tions or non-conformance of shorter tion record forms may be issued to an duration or less serious nature. accredited processor, and the said proc- (b) A license to inspect, grade and essor shall be responsible for and ac- certify naval stores may be summarily countable to the Department for all suspended or revoked by any official such material supplied to him. He shall authorized to issue or countersign such require the licensed inspector to sub- licenses where the public health, inter- mit or otherwise make disposition of est, or safety so requires or for willful issued certificates in accordance with acts or omissions by the licensee which instructions received from the Admin- constitute grounds for suspension or istrator. revocation of his license under para- graph (a) of this section. In all other § 160.50 Reports to be made by accred- cases, prior to the institution of pro- ited processors. ceedings for the suspension or revoca- Each accredited processor shall fur- tion of a license, such authorized offi- nish the Administrator such reports cial shall cause to be served upon the and other information relative to the licensee, in person or by registered operation and output of his eligible mail, a statement of the facts which processing plant as the Administrator appear to warrant such suspension or may deem necessary or appropriate for revocation, specifying a reasonable the administration of the provisions in time, depending upon the cir- this part applicable to licensed inspec- cumstances in each case, within which tion, subject to the approval of the Bu- the licensee may demonstrate or reau of the Budget. Failure by an ac- achieve compliance with the act, and credited processor to keep such records the provisions in this part. The li- as may be necessary for him to submit censee may demonstrate compliance by correct reports, or failure by the proc- the presentation of evidence in writing essor to supply correct information to or, in the discretion of such authorized the Administrator shall be deemed a official, at an oral hearing. If, at the violation of the provisions in this part, end of the time allowed for the licensee and cause for suspension or revocation to demonstrate or achieve compliance, of his inspection permit. such authorized official finds he is in compliance, his license shall not be § 160.51 Report of non-conformance. suspended or revoked. If such author- Each licensed inspector shall prompt- ized official finds the licensee is not in ly report to his supervising inspector compliance, the license may be sus- and to the accredited processor, any pended or revoked after service upon evidence of which he has knowledge in- the licensee, in person or by registered dicating non-conformance with the mail, of a notice that such action is provisions in this part, and shall also under consideration for reasons speci- so report any attempt or effort to in- fied in the statement of facts pre- fluence him to sample, grade, or certify viously served upon him and after rea- any naval stores incorrectly or con- sonable opportunity is given the li- trary to the provisions in this part. censee to present further evidence in his behalf. Within 7 days after receipt § 160.52 Suspension or revocation of li- of notice of the suspension or revoca- censes. tion of his license, the inspector by let- (a) Any license to inspect, grade, and ter may appeal to the Administrator certify naval stores may be suspended for its reinstatement and may attach or revoked for repeated failure by the to such letter any evidence he may licensee correctly to inspect, grade, wish to submit. classify, or certify naval stores, or upon the persistence of any condition § 160.53 Stopping inspection by sus- which renders him unfit to perform the pended inspector. duties of a licensed inspector, or for An accredited processor upon receipt other continued non-conformance with of notice of the suspension or revoca- any provision of the act or the provi- tion of a license shall discontinue the
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use of the licensee as an official inspec- ation for reasons specified in the state- tor, and the marking of his products to ment of facts previously served upon indicate official inspection, until the him after reasonable opportunity is suspension is lifted, or another inspec- given the permittee to present further tor is licensed or assigned. evidence in his behalf. Within 7 days after receipt of notice of the suspension § 160.54 Suspension or revocation of or revocation of his permit, the proc- permits. essor by letter may appeal to the Ad- (a) Any permit issued to an accred- ministrator for its reinstatement, and ited processor to have naval stores in- may attach to such letter any evidence spected, graded, and certified by a li- he may wish to submit. censed inspector may be suspended or revoked for the failure of the processor, § 160.55 Voluntary discontinuance of after official notice, to correct any licensed inspection. condition which renders his plant un- An accredited processor desiring to qualified for licensed inspection serv- discontinue the use of licensed inspec- ice, or for repeated or continued non- tors for making official inspections, conformance with any other provision gradings, and certifications of naval of the act or the provisions in this stores, shall give not less than 30 days part. A permit may be suspended for notice in writing to the Administrator similar non-conformance or failure of of the intention to discontinue such shorter duration or less serious nature. service. At the termination of the serv- (b) A permit for licensed inspection ice such processor shall surrender to may be summarily suspended or re- the authorized representative of the voked by any official authorized to Administrator the permit for licensed issue or countersign such permits inspection, together with all unused where the public health, interest, or certificates, forms, or other supplies safety so requires or for willful acts or and equipment furnished by the De- omissions by the permittee which con- partment and held by the processor for stitute grounds for suspension or rev- the use of his licensed inspectors, other ocation of his permit under paragraph than standards or such other material (a) of this section. In all other cases, as may be covered by a separate loan prior to the institution of proceedings application or agreement. for the suspension or revocation of a permit, such authorized official shall § 160.56 Compensation of licensed in- cause to be served upon the permittee, spectors. in person or by registered mail, a state- ment of the facts which appear to war- Each licensed inspector shall be paid rant such suspension or revocation, directly by the accredited processor for specifying a reasonable time, depend- his services as an official inspector and ing upon the circumstances in each for such other services or duties to case, within which the permittee may which he may be assigned in accord- demonstrate or achieve compliance ance with § 160.44: Provided, That when- with the act and the provisions in this ever the Administrator shall deem it to part. The permittee may demonstrate be in the best interest of the Federal compliance by the presentation of evi- inspection service, he may require such dence in writing or, in the discretion of processor to report to him the terms such authorized official, at an oral and amounts of compensation paid to a hearing. If, at the end of the time al- licensed inspector during any specified lowed for the permittee to demonstrate period. or achieve compliance, such authorized official finds he is in compliance, his § 160.57 Fees for licensed inspection permit shall not be suspended or re- permits. voked. If such authorized official finds Each accredited processor shall pay the permittee is not in compliance, the to the Department annually such per- permit may be suspended or revoked mit fee for each eligible processing after service upon the permittee, in plant for which a permit has been person or by registered mail, of a no- issued, as may be prescribed by the Ad- tice that such action is under consider- ministrator.
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§ 160.58 Fees for inspection and certifi- (f) Classification and grade certifi- cation by licensed inspectors. cate for rosin in small containers. Each accredited processor for whom § 160.62 When a certificate may be naval stores have been inspected and issued. certified hereunder by a licensed in- spector during any calendar month A certificate showing the results of shall on receipt of invoice pay to the any analysis, classification, or grading Department the fee for each container shall be issued on any naval stores of naval stores so inspected and cer- which conform with a United States tified as may be prescribed by the Ad- Standard as to kind and grade and ministrator. which have been sampled by or under the direction and supervision of an offi- § 160.59 Appeal inspections. cial inspector in accordance with the provisions in this part. The certificate Any inspection certificate issued by a shall be valid only so long as the naval licensed inspector may be appealed in stores described therein shall remain writing to the Administrator, such ap- under seal or in the identical condition peal to state the circumstances, the obtaining at the time of their examina- certificate number, and the quantity tion. and certified grade of the naval stores covered thereby. A prompt regrade in- § 160.63 When a certificate may not be spection shall be made by an official issued. inspector other than the original in- No certificate shall be issued for spector. naval stores unless the naval stores have been packed, sampled, marked, § 160.60 Charge for appeal inspection. and identified as required by the provi- If the findings in an appeal inspec- sions in this part, and otherwise con- tion confirm the original inspection, form with the act and such provisions. the accredited processor shall pay for The results of the examination of such such reinspection in accordance with naval stores or anything offered as the fees established for original inspec- such may be covered by a written re- tions made by inspectors who are paid port, which in no case shall be con- employees of the Department. If the strued as a certificate. findings do not confirm the original in- spection, a corrected certificate will be § 160.64 Issuance of loan and sale cer- issued and no charge will be made for tificate. re-inspection. On request of the owner, a ‘‘Loan and Sale Certificate for United States CERTIFICATES AND REPORTS Graded Rosin’’ (designated ‘‘L. S. Cer- tificate’’ in this part) may be issued to § 160.61 Kinds of certificates issued. cover any rosin for which a Rosin Clas- A certificate as provided for by sec- sification and Grade Certificate has tion 4 of the act shall be issued to the previously been issued by an official in- interested person in duplicate covering spector, and which remains in the naval stores examined at his request, original container. No inspector shall and additional copies, if desired, may issue and L. S. Certificate until he has be obtained from the inspector. The made certain that the rosin had pre- kind of certificates issued are as fol- viously been officially inspected and lows: certified. The request for such certifi- (a) Turpentine analysis and classi- cate may be made to the nearest in- fication certificate. spector. (b) Turpentine field classification certificate. § 160.65 Prior certification required. (c) Rosin classification and grade cer- If an L. S. Certificate is desired for a tificate. quantity of rosin, a part of which has (d) Rosin grade and weight certifi- not been previously classified and grad- cate. ed by an official inspector and covered (e) Loan and sale certificate for by a certificate, such part shall be so United States graded rosin. inspected, classified, graded, marked,
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and certified, as provided by the provi- services have been performed, a claim sions in this part. for payment of moneys due the United States for the services rendered or for FEES AND CHARGES FOR SERVICES the loan or repair of any standards. RENDERED [11 FR 14665, Dec. 27, 1946, as amended at 17 § 160.66 Fees for inspection services. FR 221, Jan. 9, 1952; 20 FR 6433, Sept. 1, 1955. The Administrator shall from time to Redesignated at 46 FR 47055, Sept. 24, 1981, as amended at 47 FR 3345, Jan. 25, 1982] time establish fees and charges for ex- amination, sampling, classification, § 160.71 Delinquent claims. grading, analysis and certification of naval stores as he may deem fair and Any claim remaining unpaid after 30 reasonable, and commensurate with days from the date of its rendition the cost of the service rendered. Such shall be considered as delinquent, and fees and charges may be announced to notice thereof shall be brought to the the trade in such manner as the Ad- attention of the interested person. ministrator considers practicable. After a claim becomes delinquent, the Administrator shall suspend or deny § 160.67 Fees under cooperative agree- inspection and related services to any ments. interested party who has failed to Fees and charges for any inspection make timely payment of the fees and and grading service covered by the charges assessed, as well as any claims terms of any cooperative agreement which have been rendered, and shall with any interested person may be es- take such action as may be necessary tablished by and incorporated into to collect any amounts due. A deposit such agreement. in advance sufficient to cover the fees and expenses for any subsequent serv- § 160.68 Collection of fees. ice may be required of any person fail- Beginning October 1, 1981, all fees and ing to pay his claim after issuance of charges assessed to interested parties such notice of delinquency. for services rendered under the Naval [11 FR 14665, Dec. 27, 1946, as amended at 17 Stores Act shall be collected by the Di- FR 221, Jan. 9, 1952; 20 FR 6433, Sept. 1, 1955. rector, Tobacco Division, Agricultural Redesignated and amended at 46 FR 47055, Marketing Service, to cover insofar as Sept. 24, 1981; 47 FR 3345, Jan. 25, 1982] practicable, all costs of providing such services. Such fees shall be credited to LOAN AND CARE OF UNITED STATES the Division in accordance with fiscal STANDARDS regulations of the Department. § 160.73 Availability of standards. [47 FR 3345, Jan. 25, 1982] (a) Standards available on loan. Dupli- § 160.69 Expenses to be borne by per- cates of the United States Standards son requesting service. provided by the Department for All expenses incurred by the United classifying and grading rosin in com- States in connection with the sam- merce, shall remain the property of the pling, analysis, classification, or grad- Department, and may be loaned, but ing of naval stores on request, not oth- not sold, to such interested persons as erwise provided for by suitable regula- may be approved by the Administrator. tion, shall be borne by the person mak- Any interested person desiring the loan ing the request. of duplicates of the United States [11 FR 14665, Dec. 27, 1946, as amended at 17 Standards for rosin shall submit to the FR 221, Jan. 9, 1952; 20 FR 6433, Sept. 1, 1955. Administrator a form application, Redesignated at 46 FR 47055, Sept. 24, 1981, as properly signed, which will show his in- amended at 47 FR 3345, Jan. 25, 1982] terest in naval stores and his eligi- bility to receive and use such dupli- § 160.70 Rendition of claims. cates, in accordance with the provi- As soon as practicable after the end sions in this part. Standards so loaned of each month, or sooner if deemed ad- shall be returned promptly on request. visable, there shall be mailed to each (b) Standards available for purchase. interested person at whose request any Duplicate cubes for rosin standard
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grades XA, XB, and XC are not avail- $100, by remittance payable to the able from the Department but may be Treasurer of the United States. obtained commercially. § 160.76 Annual charge for use of [11 FR 14665, Dec. 27, 1946, as amended at 17 standards. FR 221, Jan. 9, 1952; 20 FR 6433, Sept. 1, 1955; The cost of providing duplicates of 33 FR 8722, June 14, 1968] the United States Standards for rosin, § 160.74 Loan of standards without se- and of maintaining such duplicates in curity. accurate and proper condition for use in grading rosin, and of keeping nec- Duplicates of the United States essary records thereof, shall be borne Standards for rosin may be loaned by the interested persons to whom the without deposit of security, insofar as duplicates have been issued under the supply in the possession of the De- § 160.74 (a) or (b) or § 160.75, and shall be partment will permit, to: defrayed by an annual charge of $20.00 (a) Any State, County, or Municipal for each set of duplicates, payable at official duly authorized to inspect and the end of each Government fiscal grade rosin, who is actually engaged in year, or on surrender of the duplicates, inspection and grading work, and who computed pro-rata for the number of shall have been approved by the Ad- quarters of the fiscal year during which ministrator to act as custodian of such the duplicates were held: Provided, standards. That when any set of standards issued (b) Any bona fide dealer or dis- on loan shall need servicing more often tributor of rosin who shall have been than once in any fiscal year, in order approved by the Administrator to act to maintain them in accurate condi- as depositary for such standards, and tion for grading, and the need for such who shall maintain and operate a reg- extra servicing is deemed by the Ad- ular naval stores yard which is avail- ministrator to be the result of im- able to and is regularly used by other proper handling and use of the stand- persons for the purpose of having rosin ards by the interested person or his inspected, graded, stored, or sold there- agent, such person shall pay an addi- on: Provided, however, That a person tional amount of $30.00 for each such whose principal use of such standards additional servicing, plus the cost of is the grading of rosin of his own pro- any parts or components of the stand- duction shall not be deemed to come ards replaced in such servicing, and within the scope of this paragraph, but any postage charges incurred by the shall be required to post the security Department in connection therewith. provided for in § 160.75: And provided, [11 FR 14665, Dec. 27, 1946, as amended at 17 further, That no person shall receive FR 221, Jan. 9, 1952; 20 FR 6433, Sept. 1, 1955; more than two sets of duplicates under 46 FR 47055, Sept. 24, 1981; 47 FR 3345, Jan. 25, this paragraph. 1982] (c) Any trade organization or institu- tion of higher learning having a direct § 160.77 Reporting on use of standards. relationship to the production or mar- Each person to whom any duplicates keting of naval stores other than by of the United States Standards for reason of the private interests or oper- rosin have been loaned under any pro- ations of its individual members, when vision in this part shall, from time to in the opinion of the Administrator time, submit such reports on the use such standards are necessary to the and condition thereof as may be re- normal functioning of the organization quired by the Administrator. or institution. § 160.78 Loss or damage of standards. § 160.75 Loan of standards under secu- In case any duplicates become dam- rity deposit. aged or are missing, the person to Duplicates of the United States whom they were loaned shall promptly Standards for rosin may be loaned to inform the Administrator in writing, interested persons other than those stating what damage or loss was sus- specified in § 160.74, on deposit with the tained and how the same occurred. The Department of security in the sum of cost of making necessary repairs to
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any duplicates, or of replacing those from whom received, or his legal rep- damaged beyond repair, or missing, resentative, on surrender of the dupli- shall be paid promptly by the person to cates secured thereby: Provided, That whom they were originally loaned. before refund is made the cost of any repairs or replacement shall be de- § 160.79 Request for additional stand- ducted. ards. Any person to whom any duplicates § 160.83 Miscellaneous receipts. have been loaned without security de- All moneys received or withheld to posit, who shall request and be granted the loan of additional duplicates to re- cover the cost of repairs, or of replac- place the original ones, shall be re- ing any missing parts of duplicates, or quired to deposit the security provided as rental for duplicates, shall be paid for in § 160.75 prior to the loan of such into the United States Treasury as additional duplicates. If the set of du- Miscellaneous Receipts. plicates first loaned to such person, or any part thereof, is recovered, it shall SALES AND SHIPMENTS be returned for inspection or repair. § 160.84 Identification of shipments. The cost of any repairs or replacements shall be paid, whereupon such original The invoice or contract of sale of any set may be returned to such person, naval stores in commerce shall identify and he shall surrender the second set, and describe the article in accordance on receipt of which the security posted with the classification and the stand- therefor shall be returned. ard of kind and grade provided by the act or established by the Adminis- § 160.80 Denial of loan of additional trator. standards. It shall be deemed impracticable § 160.85 Sale of mixed turpentine not under the act to loan additional dupli- lawful. cates to any person who has permitted Since no standard has been provided duplicates previously loaned to him, for a mixture of two or more kinds of without security, to become lost, dam- spirits of turpentine, the sale in com- aged, or destroyed, if in the opinion of merce of any such mixture is prohib- the Administrator, such loss, damage, ited under any designation. or destruction resulted from any fail- ure on the part of the interested person § 160.86 Prohibited use of United or his agent to take suitable pre- States Standards. caution to prevent the loss, damage, or destruction, or when the available sup- It shall be deemed unlawful under ply of duplicates is deemed insufficient any condition to sell, under or by ref- to warrant the loan of additional dupli- erence to any United States Standard cates to such person. for naval stores, as provided by the act and defined in the regulations in this § 160.81 Surrender of standards. part, any article which fails to conform On the death of any person, or the with such standard in all respects: Pro- dissolution or reorganization of any vided, That the phrase ‘‘under or by ref- partnership, firm, or corporation, hold- erence to United States Standards’’ as ing any duplicates of the United States it appears in the act and the regula- Standards for rosin, they shall be tions in this part, shall include the use promptly returned to the Adminis- of any words, letters, brands, labels, or trator by the holder thereof. marks constituting any of the United States Standards for naval stores on § 160.82 Return of security. any container of naval stores, on any- The security deposit received from thing attached to or supplied therewith any person to whom duplicates of the on delivery, or on any inspection, sale, United States Standards for rosin have or shipping record or invoice, in de- been loaned will be held in the special scribing the kind, classification, or deposit account of the Department, and grade of the naval stores covered there- the same will be returned to the person by.
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§ 160.87 Prohibited use of word ‘‘tur- § 160.92 Meaning of word ‘‘gallon.’’ pentine’’ or derivatives thereof. The word ‘‘gallon,’’ when used on or It shall be deemed unlawful to use in impressed into any container of spirits commerce the word ‘‘turpentine’’ or a of turpentine, or when used in an in- compound, derivative or imitation voice referring to spirits of turpentine thereof, or any word or combination of in containers of 10 gallons content or words which are a part of a United less, shall mean a United States stand- States Standard for any kind of spirits ard gallon of 231 cubic inches of turpen- of turpentine, to describe in any man- tine, regardless of any other definitive terms used therewith: That ner a mixture of spirits of turpentine Provided, this shall not apply to the meaning of with any other oil or solvent. the words ‘‘imperial gallon’’, when § 160.88 Permitted use of words ‘‘tur- placed on containers intended for for- pentine’’ and ‘‘rosin.’’ eign shipment. For the purpose of these regulations a measured gallon of tur- The use of the word ‘‘turpentine’’ or pentine, or any indicated multiple or the word ‘‘rosin’’ is not prohibited in fractional part thereof, shall be such the name of an article made, prepared, quantity when measured at a tempera- or processed from spirits of turpentine ture of not more than 75 °Fahrenheit, or rosin, or to indicate the process and a weighed gallon shall be construed whereby such article was made or pre- to mean 7.2 pounds of turpentine. pared: Provided, That this section shall not apply to any article covered by § 160.93 Powdered rosin. § 160.87. The classification and grade of any rosin sold in commerce in a powdered § 160.89 Medicinal preparations. or finely broken condition shall be A compound or mixture containing stated in the invoice or contract of sale spirits of turpentine or rosin, or both, in accordance with the kind and grade of the rosin before it was powdered or with other drugs, when sold for medic- broken. For the purpose of preventing inal purposes, is not subject to the pro- coalescence there may be incorporated visions of the Naval Stores Act or of in such article a limited and necessary the provisions in this part. quantity of inert, nonresinous foreign material: Provided, That the nature and LABELING, ADVERTISING AND PACKING quantity of such inert material shall be § 160.90 False, misleading, or deceitful stated on the label. practices. § 160.94 Spirits of turpentine for me- No label or other means or practice dicinal use. used in connection with the sale of Spirits of turpentine so packed, de- naval stores in commerce or of any- scribed, labeled, or sold as to indicate thing offered as such shall be false, that it is offered as a medicament shall misleading, or deceitful in any manner. nevertheless be subject to the require- ments of the Naval Stores Act and of § 160.91 Meaning of words ‘‘pine’’ and the provisions in this part, as well as ‘‘pine tree.’’ any requirements under any other stat- The words ‘‘pine’’ or ‘‘pine tree,’’ ute. when used to designate the source of PROCEEDINGS IN ASE OF IOLATION spirits of turpentine, shall be deemed C V to mean a living, growing plant of the § 160.95 Proceedings prior to reporting genus Pinus, family Pinaceae, unless violations of the act. the words ‘‘wood of’’ are used in con- Whenever it shall appear to the Ad- nection therewith. The terms ‘‘oleo- ministrator that any violation of the resin of the southern pine’’ or ‘‘oleo- act should be reported to the United resin from the southern pine’’ shall be States Department of Justice for ap- deemed to mean the gum or oleoresin propriate action, he shall serve notice exuded by such living, growing trees, in writing upon the person apparently the source of gum spirits of turpentine. responsible for the alleged violation
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and shall give such person an oppor- (i) In drums (see Note 1) per drum— tunity to show in duplicate to the Ad- $1.24. ministrator within 20 days after the re- (ii) In 100 pound bags (see Note 1) per ceipt of such notice why the alleged bag—$.23. violation should not be reported to the (iii) In tank cars, per car—$67.50. Department of Justice. The person so (iv) In tank trucks, per truck—$34.00. notified may within the period stated (2) Turpentine (Grading and inci- apply for an opportunity to present his dental certification as to class, condi- views in person, or by his attorney. If tion and volume). the Administrator deems the request (i) In 55 gallon drums, per drum— appropriate he will designate a time $2.25. and place for hearing the applicant. (ii) In tank cars or trucks, per unit of 100 gallons—$1.41. § 160.96 Report of violations for pros- (iii) In bulk for delivery to tank ecution. steamer, per unit of 100 gallons—$2.25. In the event of failure of the person (b) Inspections by regularly em- notified of an apparent violation of the ployed, salaried Federal inspectors. act to submit to the Administrator a (1) Rosin. written answer as provided in § 160.95, (i) Grading and weighing at con- or if, after such person has filed his an- centration and storage yards, per swer or in addition, been given an op- drum—$4.05. portunity to present his views orally, (ii) Irregular inspection and grading no sufficient reason has been shown at distillation or processing plants, up why the alleged violation should not be to 400 drums, per drum—$3.60; all over reported for prosecution, the General 400 drums, per drum—$2.25. Counsel of the Department, acting for (iii) Weighing at concentration and and on behalf of the Administrator, storage yards, subsequent to grading, shall report the alleged violation to the per drum—$2.25. Department of Justice for appropriate (iv) Examination of the external or action. internal appearance and condition of filled rosin drums, and of the rosin con- § 160.97 Publication. tained therein—See Note 2 and § 160.204. Composite data regarding inspec- (v) Re-certification under L.S. Cer- tions, analyses, classifications, and tificate of rosin moving in commerce, grading of naval stores made under any per drum—$.23. provision of the act or the provisions in (2) Turpentine (inspection and cer- this part may be published from time tification as to kind, condition, vol- to time in such mediums as the Admin- ume, etc.). istrator may designate for the purpose. (i) In drums of 55 gallons, per drum— $3.38. SPECIFIC FEES PAYABLE FOR SERVICES (ii) In tank cars or trucks, per unit of RENDERED 100 gallons—$2.81. § 160.201 Fees generally for field in- (iii) For bulk delivery to tank steam- spection and certification of naval er, per unit of 100 gallons—$2.25. stores and drum containers of NOTE 1: When the number of drums and rosin. bags inspected and certified at any plant during any calendar month is equivalent to a Except as provided in § 160.204, the total of 2,400 or more drums (counting five following fees shall be paid to the bags as equivalent to one drum), the fee shall United States for the field inspection be computed at the rate of $1.01 per drum and certification of naval stores and and $.18 per bag certified. For quantities less drum containers of rosin, not con- than the equivalent of 2,400 drums, the fee ducted under a cooperative agreement shall be computed at the prescribed rate of and where laboratory analysis or test- $1.24 per drum and $.23 per bag. ing is not required: NOTE 2: The inspection or related examina- (a) Inspections by licensed inspectors at tion of containers of rosin and their contents under Section B(1)(iv) shall be performed eligible processing plants. only after the inspector or the Chief of the (1) Rosin (grading and incidental cer- Marketing Programs Branch has been ad- tification as to class, condition and vised regarding the location, nature, scope, weight). and purpose of the service desired, and the
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charge to be made therefore has been sub- shall be the same as the fees prescribed mitted to and accepted by the requesting for spirits of turpentine. person. [17 FR 189, Jan. 8, 1952] [47 FR 3345, Jan. 25, 1982] § 160.204 Fees for extra cost and hour- § 160.202 Fees generally for laboratory ly rate service. analysis and testing. The fees specified in §§ 160.201 and Except as provided in § 160.204, the 160.202 apply to the routine field in- following fees shall be paid to the spection and usual laboratory work in- United States for laboratory analysis cident to the certification of commod- and testing of naval stores, when not ities covered by those sections. Should performed in the conduct of a coopera- additional work be required to provide tive agreement with respect to such special information desired by the per- products: son requesting service, or should it be (a) Rosin and turpentine. (See Note 3). necessary for an inspector to make a (1) Comprehensive analysis to deter- special trip or to deviate from his reg- mine purity, specification compliance, ular schedule of travel, or should the or other chemical and physical prop- fees prescribed in §§ 160.201 and 160.202 erties related thereto: otherwise be insufficient to defray the (i) Single Sample—$40.00. cost to the Government for rendering (ii) Two or more samples analyzed at such service, then the person request- same time per sample—$35.00. ing the service shall pay, in lieu of the (2) Limited testing to determine prescribed fees, an amount computed kind, grade, or other factors related to by the Department as sufficient to de- quality of utility. fray the total cost thereof, including (i) Single Sample: allowances for time spent in collecting (A) Rosin—$14.00. and preparing samples obtaining iden- (B) Turpentine—$10.00. tification records, traveling, per- forming laboratory tests or other nec- (ii) Two or more samples tested at essary work, and also any expense in- same time: curred for authorized transportation (A) Rosin—per sample—$10.00. and subsistence of the inspector or ana- (B) Turpentine—per sample—$8.00. lyst while in travel status. The charge NOTE 3: The analysis and testing of rosin for time so spent shall be computed at involves many different types of laboratory the rate of $17.80 per hour for labora- procedures, requiring variable time for per- tory and field inspection work. The formance, and including other cost factors. The charge for such analysis and testing will overtime rate for services performed depend on the type and extent of the work outside the inspector’s regularly sched- required to supply the information desired uled tour of duty shall be $21.30. The by the interested person requesting the serv- rate of $26.70 shall be charged for work ice. When it appears that the charges indi- performed on Sundays or holidays. cated in this section will not defray the costs of making the tests required, the interested [47 FR 3345, Jan. 25, 1982] person shall be informed before any work is performed and will be supplied with a cost § 160.205 Permit fees for eligible proc- estimate of the actual charges to be made. essing plants under licensed inspec- See also § 160.204. tion. [47 FR 3345, Jan. 25, 1982] Initial permit fee—$20.00. Annual renewal permit fee—$20.00. § 160.203 Fees for inspection and cer- NOTE: The renewal permit fee shall be re- tification of other naval stores ma- duced to $10 per year when the inspection terial. fees paid by the eligible processing plant ag- gregate $200 or more during the preceding Whenever it shall be deemed prac- fiscal year ended September 30, and shall be tical and in the interest of the naval waived when such fees aggregate $400 or stores trade to sample, inspect, analyze more during such fiscal year. Such reduced and certify any naval stores material permit fee shall apply only in case the eligi- other than spirits of turpentine or ble processing plant has made use of the li- rosin, at the request of an interested censed inspection service. person, the fees for such inspection [47 FR 3346, Jan. 25, 1982]
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PART 201—FEDERAL SEED ACT 201.31 Germination standards for vegetable REGULATIONS seeds in interstate commerce. LABELING IN GENERAL RULES AND REGULATIONS OF THE SECRETARY 201.31a Labeling treated seed. OF AGRICULTURE 201.32 Screenings. DEFINITIONS 201.33 Seed in bulk or large quantities; seed for cleaning or processing. Sec. 201.34 Kind, variety, and type; treatment 201.1 Meaning of words. substances; designation as hybrid. 201.2 Terms defined. 201.35 Blank spaces. 201.36 The words ‘‘free’’ and ‘‘none.’’ ADMINISTRATION 201.3 Administrator. MODIFYING STATEMENTS 201.36a Disclaimers and nonwarranties. RECORDS FOR AGRICULTURAL AND VEGETABLE SEEDS ADVERTISING 201.4 Maintenance and accessibility. 201.36b Name of kind and variety; designa- 201.5 Origin. tion as hybrid. 201.6 Germination. 201.36c Hermetically-sealed containers. 201.7 Purity (including variety). 201.7a Treated seed. INSPECTION
LABELING AGRICULTURAL SEEDS 201.37 Authorization. 201.38 Importations. 201.8 Contents of the label. 201.9 Kind. SAMPLING IN THE ADMINISTRATION OF THE ACT 201.10 Variety. 201.11 Type. 201.39 General procedure. 201.11a Hybrid. 201.40 Bulk. 201.12 Name of kind and variety. 201.41 Bags. 201.12a Lawn and turf seed mixtures. 201.42 Small containers. 201.13 Lot number or other identification. 201.43 Size of sample. 201.14 Origin. 201.44 Forwarding samples. 201.15 Weed seeds. PURITY ANALYSIS IN THE ADMINISTRATION OF 201.16 Noxious-weed seeds. THE ACT 201.17 Noxious-weed seeds in the District of Columbia. 201.45 Obtaining the working sample. 201.18 Other agricultural seeds (crop seeds). 201.46 Weight of working sample. 201.19 Inert matter. 201.47 Separation. 201.20 Germination. 201.47a Seed unit. 201.21 Hard seed. 201.47b Working samples. 201.22 Date of test. 201.48 Kind or variety considered pure seed. 201.23 Name of shipper or consignee. 201.49 Other crop seed. 201.24 Code designation. 201.50 Weed seed. 201.24a Inoculated seed. 201.51 Inert matter. 201.51a Special procedures for purity anal- LABELING VEGETABLE SEEDS ysis. 201.25 Contents of the label. 201.51b Purity procedures for coated seed. 201.26 Kind, variety, and hybrid. 201.52 Noxious-weed seeds. 201.27 Name of shipper or consignee. GERMINATION TESTS IN THE ADMINISTRATION OF 201.28 Code designation. THE ACT 201.29 Germination of vegetable seed in con- tainers of 1 pound or less. 201.53 Source of seeds for germination. 201.29a Germination of vegetable seed in 201.54 Number of seeds for germination. containers of more than 1 pound. 201.55 Retests. 201.30 Hard seed. 201.55a Moisture and aeration of sub- 201.30a Date of test. stratum. 201.30b Lot number or other lot identifica- 201.56 Interpretation. tion of vegetable seed in containers of 201.56–1 Goosefoot family, Chenopodiaceae more than 1 pound. and Carpetweed family Aizoaceae.
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201.56–2 Sunflower family, Asteraceae ADDITIONAL REQUIREMENTS FOR THE CERTIFI- (Compositae). CATION OF PLANT MATERIALS OF CERTAIN 201.56–3 Mustard family, Brassicaceae CROPS (Cruciferae). 201.77 Length of stand requirements. 201.56–4 Cucurbit family (Cucurbitaceae). 201.78 Pollen control for hybrids. 201.56–5 Grass family, Poaceae (Gramineae). 201.56–6 Legume or pea family, Fabaceae AUTHORITY: 7 U.S.C. 1592. NOTE: Approved by the Office of Manage- (Leguminosae). ment and Budget under OMB control number 201.56–7 Lily family, Liliaceae. 0581–0026 (47 FR 746, Jan. 7, 1982) 201.56–8 Flax family, Linaceae. 201.56–9 Mallow family, Malvaceae. RULES AND REGULATIONS OF THE 201.56–10 Spurge family, Euphorbiaceae. SECRETARY OF AGRICULTURE 201.56–11 Knotweed family, Polygonaceae. 201.56–12 Miscellaneous plant families. DEFINITIONS 201.57 Hard seeds. 201.57a Dormant seeds. § 201.1 Meaning of words. 201.58 Substrata, temperature, duration of Words in the regulations in this part test, and certain other specific directions in the singular form shall be deemed to for testing for germination and hard import the plural, and vice versa, as seed. the case may demand. EXAMINATIONS IN THE ADMINISTRATION OF THE [5 FR 28, Jan. 4, 1940] ACT 201.58a Indistinguishable seeds. § 201.2 Terms defined. 201.58b Origin. When used in the regulations in this 201.58c Detection of captan, mercury, or part the terms as defined in section 101 thiram on seed. of the Act, unless modified in this sec- 201.58d Fungal endophyte test. tion as provided in the Act, shall apply
TOLERANCES with equal force and effect. In addition, as used in §§ 201.1 through 201.159: 201.59 Application. (a) The Act. The term ‘‘Act’’ means 201.60 Purity percentages. the FSA approved August 9, 1939 (53 201.61 Fluorescence percentages in Stat. 1275; 7 U.S.C. 1551–1611 as amend- ryegrasses. ed); 201.62 Tests for determination of percent- (b) Person. The term ‘‘person’’ in- ages of kind, variety, type, hybrid, or offtype. cludes a partnership, corporation, com- 201.63 Germination. pany, society, association, receiver, or 201.64 Pure live seed. trustee; 201.65 Noxious weed seeds in interstate com- (c) Secretary. The term ‘‘Secretary’’ merce. means the Secretary of Agriculture of 201.66 [Reserved] the United States, or any officer or em- ployee of the Department to whom au- CERTIFIED SEED thority has heretofore been delegated, 201.67 Seed certifying agency standards and or to whom authority may hereafter be procedures. delegated, to act in his stead; 201.68 Eligibility requirements for certifi- (d) Hearing Clerk. The term ‘‘Hearing cation of varieties. Clerk’’ means the Hearing Clerk, 201.69 Classes of certified seed. United States Department of Agri- 201.70 Limitations of generations for cer- culture, Washington, DC; tified seed. (e) Respondent. The term ‘‘respond- 201.71 Establishing the source of all classes ent’’ means a person against whom a of certified seed. complaint is issued; 201.72 Production of all classes of certified (f) Examiner. The term ‘‘examiner’’ seed. means an employee of the Department 201.73 Processors and processing of all class- es of certified seed. of Agriculture, designated by the Sec- 201.74 Labeling of all classes of certified retary to conduct hearings under the seed. act, and §§ 201.1 through 201.159; 201.75 Interagency certification. (g) FEDERAL REGISTER. The term 201.76 Minimum Land, Isolation, Field, and ‘‘FEDERAL REGISTER’’ means the publi- Seed Standards. cation provided by the Act of July 26,
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1935 (49 Stat. 500), and acts supple- Burnet, little—Sanguisorba minor Scop. mentary thereto and amendatory Buttonclover—Medicago orbicularis (L.) thereof; Bartal. (h) Agricultural seeds. The term ‘‘agri- Canarygrass—Phalaris canariensis L. Canarygrass, reed—Phalaris arundinacea L. cultural seeds’’ means the following Carpetgrass—Axonopus fissifolius (Raddi) kinds of grass, forage, and field crop Kuhlm. seeds, that are used for seeding pur- Castorbean—Ricinus communis L. poses in the United States: Chess, soft—Bromus hordeaceus L. Agrotricum—x Agrotriticum Ciferri and Chickpea—Cicer arietinum L. Giacom. Clover, alsike—Trifolium hybridum L. Alfalfa—Medicago sativa L. Clover, arrowleaf—Trifolium vesiculosum Savi Alfilaria—Erodium cicutarium (L.) L’Her. Clover, berseem—Trifolium alexandrinum L. Alyceclover—Alysicarpus vaginalis (L.) DC. Clover, cluster—Trifolium glomeratum L. Bahiagrass—Paspalum notatum Fluegge Clover, crimson—Trifolium incarnatum L. Barley—Hordeum vulgare L. Clover, Kenya—Trifolium semipilosum Fresen. Barrelclover—Medicago truncatula Gaertn. Clover, ladino—Trifolium repens L. Bean, adzuki—Vigna angularis (Willd.) Ohwi Clover, lappa—Trifolium lappaceum L. and Ohashi Clover, large hop—Trifolium campestre Bean, field—Phaseolus vulgaris L. Schreb. Bean, mung—Vigna radiata (L.) Wilczek Clover, Persian—Trifolium resupinatum L. Beet, field—Beta vulgaris L. subsp. vulgaris Clover, red or Beet, sugar—Beta vulgaris L. subsp. vulgaris Red clover, mammoth—Trifolium Beggarweed, Florida—Desmodium tortuosum pratense L. (Sw.) DC. Red clover, medium—Trifolium Bentgrass, colonial—Agrostis capillaris L. pratense L. Bentgrass, creeping—Agrostis stolonifera L. var. palustris (Huds.) Farw. Clover, rose—Trifolium hirtum All. Bentgrass, velvet—Agrostis canina L. Clover, small hop or suckling—Trifolium Bermudagrass—Cynodon dactylon (L.) Pers. dubium Sibth. var. dactylon Clover, strawberry—Trifolium fragiferum L. Bermudagrass, giant—Cynodon dactylon (L.) Clover, sub or subterranean—Trifolium Pers. var. Aridus Harlan and de Wet subterraneum L. Bluegrass, annual—Poa annua L. Clover, white—Trifolium repens L. (also see Bluegrass, bulbous—Poa bulbosa L. Clover, ladino) Bluegrass, Canada—Poa compressa L. Clover—(also see Alyceclover, Burclover, Bluegrass, glaucantha—Poa glauca Vahl Buttonclover, Sourclover, Sweetclover) Bluegrass, Kentucky—Poa pratensis L. Corn, field—Zea mays L. Bluegrass, Nevada—Poa secunda J.S. Presl Corn, pop—Zea mays L. Bluegrass, rough—Poa trivialis L. Cotton—Gossypium spp. Bluegrass, Texas—Poa arachnifera Torr. Cowpea—Vigna unguiculata (L.) Walp. subsp. Bluegrass, wood—Poa nemoralis L. unguiculata Bluejoint—Calamagrostis canadensis (Michx.) Crambe—Crambe abyssinica R.E. Fries P. Beauv. Crested dogtail—Cynosurus cristatus L. Bluestem, big—Andropogon gerardii Vitm. Crotalaria, lance—Crotalaria lanceolata E. var. gerardii Mey. Bluestem, little—Schizachyrium scoparium Crotalaria, showy—Crotalaria spectabilis Roth (Michx.) Nash Crotalaria, slenderleaf—Crotalaria brevidens Bluestem, sand—Andropogon hallii Hack. Benth. var. intermedia (Kotschy) Polh. Bluestem, yellow—Bothriochloa ischaemum Crotalaria, striped or smooth—Crotalaria (L.) Keng pallida Ait. Bottlebrush-squirreltail—Elymus elymoides Crotalaria, sunn—Crotalaria juncea L. (Raf.) Swezey Crownvetch—Coronilla varia L. Brome, field—Bromus arvensis L. Dallisgrass—Paspalum dilatatum Poir. Brome, meadow—Bromus biebersteinii Roem. Dichondra—Dichondra repens Forst. and and Schult. Forst. f. Brome, mountain—Bromus marginatus Steud. Dropseed, sand—Sporobolus cryptandrus Brome, smooth—Bromus inermis Leyss. (Torr.) A. Gray Broomcorn—Sorghum bicolor (L.) Moench Emmer—Triticum dicoccon Schrank Buckwheat—Fagopyrum esculentum Moench Fescue, chewings—Festuca rubra L. subsp. Buffalograss—Buchloe dactyloides (Nutt.) commutata Gaud. Engelm. Fescue, hair—Festuca tenuifolia Sibth. Buffelgrass—Cenchrus ciliaris L. Fescue, hard—Festuca brevipila Tracey Burclover, California—Medicago polymorpha Fescue, meadow—Festuca pratensis Huds. L. Fescue, red—Festuca rubra L. subsp. rubra Burclover, spotted—Medicago arabica (L.) Fescue, sheep—Festuca ovina L. var. ovina Huds. Fescue, tall—Festuca arundinacea Schreb.
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Flatpea—Lathyrus sylvestris L. Panicgrass, green—Panicum maximum Jacq. Flax—Linum usitatissimum L. var. trichoglume Robyns Foxtail, creeping—Alopecurus arundinaceus Pea, field—Pisum sativum L. Poir. Peanut—Arachis hypogaea L. Foxtail, meadow—Alopecurus pratensis L. Poa trivialis—(see Bluegrass, rough) Galletagrass—Hilaria jamesii (Torr.) Benth. Rape, annual—Brassica napus L. var. annua Grama, blue—Bouteloua gracilis (Kunth) Koch Steud. Rape, bird—Brassica rapa L. subsp. rapa Grama, side-oats—Bouteloua curtipendula Rape, turnip—Brassica rapa L. subsp. (Michx.) Torr. silvestris (Lam.) Janchen Guar—Cyamopsis tetragonoloba (L.) Taub. Rape, winter—Brassica napus L. var. biennis Guineagrass—Panicum maximum Jacq. var. (Schubl. and Mart.) Reichb. maximum Redtop—Agrostis gigantea Roth Hardinggrass—Phalaris stenoptera Hack. Rescuegrass—Bromus catharticus Vahl Hemp—Cannabis sativa L. Rhodesgrass—Chloris gayana Kunth Indiangrass, yellow—Sorghastrum nutans (L.) Rice—Oryza sativa L. Nash Ricegrass, Indian—Oryzopsis hymenoides Indigo, hairy—Indigofera hirsuta L. (Roem. and Schult.) Ricker Japanese lawngrass—Zoysia japonica Steud. Roughpea—Lathyrus hirsutus L. Johnsongrass—Sorghum halepense (L.) Pers. Rye—Secale cereale L. Kenaf—Hibiscus cannabinus L. Rye, mountain—Secale strictum (K.B. Presl) Kochia, forage—Kochia prostrata (L.) Schrad. K.B. Presl subsp. strictum Ryegrass, annual or Italian—Lolium Kudzu—Pueraria montana (Lour.) Merr. var. multiflorum Lam. lobata (Willd.) Maesen and S. Almeida Ryegrass, intermediate—Lolium x hybridum Lentil—Lens culinaris Medik. Hausskn. Lespedeza, Korean—Kummerowia stipulacea Ryegrass, perennial—Lolium perenne L. (Maxim.) Makino Ryegrass, Wimmera—Lolium rigidum Gaud. Lespedeza, sericea or Chinese—Lespedeza Safflower—Carthamus tinctorius L. cuneata Sagewort, Louisiana—Artemisia ludoviciana (Dum.-Cours.) G. Don Nutt. Lespedeza, Siberian—Lespedeza juncea (L. f.) Sainfoin—Onobrychis viciifolia Scop. Pers. Saltbush, fourwing—Atriplex canescens Lespedeza, striate—Kummerowia striata (Pursh) Nutt. (Thunb.) Schindler Sesame—Sesamum indicum L. Lovegrass, sand—Eragrostis trichodes (Nutt.) Sesbania—Sesbania exaltata (Raf.) A.W. Hill Wood Smilo—Piptatherum miliaceum (L.) Coss. Lovegrass, weeping—Eragrostis curvula Sorghum—Sorghum bicolor (L.) Moench (Schrad.) Nees Sorghum almum—Sorghum x almum L. Lupine, blue—Lupinus angustifolius L. Parodi Lupine, white—Lupinus albus L. Sorghum-sudangrass—Sorghum x drummondii Lupine, yellow—Lupinus luteus L. (Steud.) Millsp. and Chase Manilagrass—Zoysia matrella (L.) Merr. Sorgrass—Rhizomatous derivatives of a Medic, black—Medicago lupulina L. johnsongrass x sorghum cross or a Milkvetch or cicer milkvetch—Astragalus johnsongrass x sudangrass cross cicer L. Southernpea—(See Cowpea) Millet, browntop—Brachiaria ramosa (L.) Sourclover—Melilotus indicus (L.) All. Stapf Soybean—Glycine max (L.) Merr. Millet, foxtail—Setaria italica (L.) Beauv. Spelt—Triticum spelta L. Millet, Japanese—Echinochloa frumentacea Sudangrass—Sorghum x drummondii (Steud.) Link Millsp. and Chase Millet, pearl—Pennisetum glaucum (L.) R. Br. Sunflower—Helianthus annuus L. Millet, proso—Panicum miliaceum L. Sweetclover, white—Melilotus albus Medik. Molassesgrass—Melinis minutiflora Beauv. Sweetclover, yellow—Melilotus officinalis Mustard, black—Brassica nigra (L.) Koch Lam. Mustard, India—Brassica juncea (L.) Czernj. Sweet vernalgrass—Anthoxanthum odoratum and Coss. L. Mustard, white—Sinapis alba L. Sweetvetch, northern—Hedysarum boreale Napiergrass—Pennisetum purpureum Nutt. Schumach. Switchgrass—Panicum virgatum L. Needlegrass, green—Stipa viridula Trin. Timothy—Phleum pratense L. Oat—Avena byzantina C. Koch, A. sativa L., Timothy, turf—Phleum bertolonii DC. A. nuda L. Tobacco—Nicotiana tabacum L. Oatgrass, tall—Arrhenatherum elatius (L.) Trefoil, big—Lotus uliginosus Schk. J.S. Presl and K.B. Presl Trefoil, birdsfoot—Lotus corniculatus L. Orchardgrass—Dactylis glomerata L. Triticale—x Triticosecale Wittm. (Secale x Panicgrass, blue—Panicum antidotale Retz. Triticum)
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Vaseygrass—Paspalum urvillei Steud. Beet—Beta vulgaris L. subsp. vulgaris Veldtgrass—Ehrharta calycina J.E. Smith Broadbean—Vicia faba L. Velvetbean—Mucuna pruriens (L.) DC. var. Broccoli—Brassica oleracea L. var. botrytis L. utilis (Wight) Burck Brussels sprouts—Brassica oleracea L. var. Velvetgrass—Holcus lanatus L. gemmifera DC. Vetch, common—Vicia sativa L. subsp. sativa Burdock, great—Arctium lappa L. Vetch, hairy—Vicia villosa Roth subsp. villosa Cabbage—Brassica oleracea L. var. capitata L. Vetch, Hungarian—Vicia pannonica Crantz Cabbage, Chinese—Brassica rapa L. subsp. Vetch, monantha—Vicia articulata Hornem. pekinensis (Lour.) Hanelt Vetch, narrowleaf or blackpod—Vicia sativa Cabbage, tronchuda—Brassica oleracea L. var. L. subsp. nigra (L.) Ehrh. costata DC. Vetch, purple—Vicia benghalensis L. Cantaloupe—(see Melon) Vetch, woollypod or winter—Vicia villosa Cardoon—Cynara cardunculus L. subsp. Roth subsp. varia (Host) Corb. cardunculus Wheat, common—Triticum aestivum L. Carrot—Daucus carota L. subsp. sativus Wheat, club—Triticum compactum Host (Hoffm.) Arcang. Wheat, durum—Triticum durum Desf. Cauliflower—Brassica oleracea L. var. botrytis Wheat, Polish—Triticum polonicum L. L. Wheat, poulard—Triticum turgidum L. Celeriac—Apium graveolens L. var. rapaceum Wheat x Agrotricum—Triticum x Agrotriticum (Mill.) Gaud. Wheatgrass, beardless—Pseudoroegneria Celery—Apium graveolens L. var. dulce (Mill.) spicata (Pursh) A. Love Pers. Wheatgrass, crested or fairway crested— Chard, Swiss—Beta vulgaris L. subsp. cicla Agropyron cristatum (L.) Gaertn. (L.) Koch Wheatgrass, crested or standard crested— Chicory—Cichorium intybus L. Agropyron desertorum (Link) Schult. Chives—Allium schoenoprasum L. Wheatgrass, intermediate—Elytrigia inter- Citron—Citrullus lanatus (Thunb.) Matsum. media (Host) Nevski subsp. intermedia and Nakai var. citroides (Bailey) Mansf. Wheatgrass, pubescent—Elytrigia intermedia Collards—Brassica oleracea L. var. acephala (Host) Nevski subsp. intermedia DC. Wheatgrass, Siberian—Agropyron fragile Corn, sweet—Zea mays L. (Roth) Candargy subsp. sibiricum (Willd.) Cornsalad—Valerianella locusta (L.) Laterrade Meld. Cowpea—Vigna unguiculata (L.) Walp. subsp. Wheatgrass, slender—Elymus trachycaulus unguiculata (Link) Shinn. Cress, garden—Lepidium sativum L. Wheatgrass, streambank—Elymus lanceolatus Cress, upland—Barbarea verna (Mill.) Asch. (Scribn. and J.G. Smith) Gould subsp. Cress, water—Rorippa nasturtium-aquaticum lanceolatus (L.) Hayek Wheatgrass, tall—Elytrigia elongata (Host) Cucumber—Cucumis sativus L. Nevski Dandelion—Taraxacum officinale Wigg. Wheatgrass, western—Pascopyrum smithii Dill—Anethum graveolens L. (Rydb.) A. Love Eggplant—Solanum melongena L. Wildrye, basin—Leymus cinereus (Scribn. and Endive—Cichorium endivia L. Merr.) A. Love Favabean (see Broadbean) Wildrye, Canada—Elymus canadensis L. Gherkin, West India—Cucumis anguria L. Wildrye, Russian—Psathyrostachys juncea Kale—Brassica oleracea L. var. acephala DC. (Fisch.) Nevski Kale, Chinese—Brassica oleracea L. var. Zoysia japonica—(see Japanese alboglabra (Bailey) Musil lawngrass) Kale, Siberian—Brassica napus L. var. Zoysia matrella—(see Manilagrass) pabularia (DC.) Reichb. (i) Vegetable seeds. The term ‘‘vege- Kohlrabi—Brassica oleracea L. var. gongylodes table seeds’’ means the seeds of the fol- L. lowing kinds that are or may be grown Leek—Allium porrum L. Lettuce—Lactuca sativa L. in gardens or on truck farms and are or Melon—Cucumis melo L. may be generally known and sold under Muskmelon—(see Melon). the name of vegetable seeds: Mustard, India—Brassica juncea (L.) Czernj. Artichoke—Cynara cardunculus L. subsp. and Coss. cardunculus Mustard, spinach—Brassica perviridis (Bailey) Asparagus—Asparagus officinalis Baker Bailey Asparagusbean or yard-long bean—Vigna Okra—Abelmoschus esculentus (L.) Moench unguiculata (L.) Onion—Allium cepa L. Walp. subsp. sesquipedalis (L.) Verdc. Onion, Welsh—Allium fistulosum L. Bean, garden—Phaseolus vulgaris L. Pak-choi—Brassica rapa L. subsp. chinensis Bean, lima—Phaseolus lunatus L. (L.) Hanelt Bean, runner or scarlet runner—Phaseolus Parsley—Petroselinum crispum (Mill.) A.W. coccineus L. Hill
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Parsnip—Pastinaca sativa L. (m) Declaration. The term ‘‘declara- Pea—Pisum sativum L. tion’’ means a written statement of a Pepper—Capsicum spp. grower, shipper, processor, dealer, or Pe-tsai—(see Chinese cabbage). Pumpkin—Cucurbita pepo L., C. moschata importer giving for any lot of seed the (Duchesne) Poiret, and C. maxima Duchesne kind, variety, type, origin, or the use Radish—Raphanus sativus L. for which the seed is intended. Rhubarb—Rheum rhabarbarum L. (n) Declaration of origin. The term Rutabaga—Brassica napus L. var. ‘‘declaration of origin’’ means a dec- napobrassica (L.) Reichb. laration of a grower or country shipper Sage—Salvia officinalis L. in the United States stating for each Salsify—Tragopogon porrifolius L. lot of agricultural seed (1) kind of seed, Savory, summer—Satureja hortensis L. Sorrel—Rumex acetosa L. (2) lot number or other identification, Southernpea—(see Cowpea) (3) State where seed was grown and the Soybean—Glycine max (L.) Merr. county where grown if to be labeled Spinach—Spinacia oleracea L. showing the origin as a portion of a Spinach, New Zealand—Tetragonia State, (4) quantity of seed, (5) date tetragonioides (Pall.) Ktze. shipped or delivered, (6) to whom sold, Squash—Cucurbita pepo L., C. moschata shipped, or delivered, and (7) the signa- (Duchesne) Poiret, and C. maxima Duchesne ture and address of the grower or coun- Tomato—Lycopersicon esculentum Mill. Tomato, husk—Physalis pubescens L. try shipper issuing the declaration. If Turnip—Brassica rapa L. subsp. rapa the declaration is issued by a grower Watermelon—Citrullus lanatus (Thunb.) and the identity of the person deliv- Matsum. and Nakai var. lanatus ering the seed is unknown to the re- (j) Regulations. The term ‘‘regula- ceiver, the motor vehicle license num- tions’’ means the rules and regulations ber or other identification of the deliv- promulgated by the Secretary of Agri- ering agency should be entered on the culture and the joint rules and regula- declaration by the receiver. If a coun- tions promulgated by the Secretary of try shipper’s declaration includes seed the Treasury and the Secretary of Ag- shipped or delivered to him by another riculture under the act. country shipper, it shall give for each (k) Joint regulations. The term ‘‘joint lot the other country shipper’s lot regulations’’ means the joint rules and number as included in the other coun- regulations promulgated by the Sec- try shipper’s declaration of origin. retary of the Treasury and the Sec- (o) Declaration of kind, variety, or type. retary of Agriculture. The term ‘‘declaration of kind, variety, (l) Complete record. (1) The term or type’’ means a declaration of a ‘‘complete record’’ means information grower stating for each lot of seed (1) which relates to the origin, treatment, the name of the kind, variety, or type germination, and purity (including va- stated in accordance with §§ 201.9 riety) of each lot of agricultural seed through 201.12, (2) lot number or other transported or delivered for transpor- identification, (3) place where seed was tation in interstate commerce, or grown, (4) quantity of seed, (5) date which relates to the treatment, germi- shipped or delivered, (6) to whom sold, nation, and variety of each lot of vege- shipped or delivered, and (7) the signa- table seed transported or delivered for ture and address of the grower issuing transportation in interstate commerce. the declaration. Such information includes seed sam- (p) Mixture. The term ‘‘mixture’’ ples and records of declarations, labels, means seeds consisting of more than purchases, sales, cleaning, bulking, one kind or variety, each present in ex- treatment, handling, storage, analyses, cess of 5 percent of the whole. tests, and examinations. (q) Coated Seed. The term ‘‘coated (2) The complete record kept by each seed’’ means any seed unit covered person for each treatment substance or with any substance that changes the lot of seed consists of the information size, shape, or weight of the original pertaining to his own transactions and seed. Seeds coated with ingredients the information received from others such as, but not limited to, rhizobia, pertaining to their transactions with dyes, and pesticides are excluded. respect to each treatment substance or (r) Grower. The term ‘‘grower’’ means lot of seed. any person who produces directly or
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through a growing contract, or is a retesting to determine the quality of seed-crop sharer in seed which is sold, the seed, but does not include oper- offered for sale, transported, or offered ations such as packaging, labeling, for transportation. blending together of uniform lots of (s) Country shipper. The term ‘‘coun- the same kind or variety without try shipper’’ means any person located cleaning, or the preparation of a mix- in a producing area who purchases seed ture without cleaning, any of which locally for shipment to seed dealers or would not require retesting to deter- to other country shippers. mine the quality of the seed. (t) Dealer. The term ‘‘dealer’’ means (aa) Agricultural Marketing Service any person who cleans, processes, sells, means the Agricultural Marketing offers for sale, transports, or delivers Service, United States Department of for transportation seeds in interstate Agriculture. commerce. (bb) Breeder seed. Breeder seed is a (u) Consumer. The term ‘‘consumer’’ class of certified seed directly con- means any person who purchases or trolled by the originating or spon- otherwise obtains seed for sowing but soring plant breeding institution, or not for resale. person, or designee thereof, and is the (v) Lot of seed. The term ‘‘lot of seed’’ source for the production of seed of the means a definite quantity of seed iden- other classes of certified seed. tified by a lot number, every portion or (cc) Foundation seed. Foundation seed bag of which is uniform, within per- is a class of certified seed which is the mitted tolerances, for the factors progeny of Breeder or Foundation seed which appear in the labeling. and is produced and handled under pro- (w) Purity. The term ‘‘purity’’ means cedures established by the certifying the name or names of the kind, type, or agency, in accordance with this part, variety and the percentage or percent- for producing the Foundation class of ages thereof; the percentage of other seed, for the purpose of maintaining ge- agricultural seed or crop seed; the per- netic purity and identity. centage of weed seeds, including nox- ious weed seeds; the percentage of inert (dd) Registered seed. Registered seed is matter; and the names of the noxious a class of certified seed which is the weed seeds and the rate of occurrence progeny of Breeder or Foundation seed of each. and is produced and handled under pro- (x) Inoculant. The term ‘‘inoculant’’ cedures established by the certifying means a commercial preparation con- agency, in accordance with this part, taining nitrogen-fixing bacteria ap- for producing the Registered class of plied to seed. seed, for the purpose of maintaining ge- (y) Hybrid. The term ‘‘hybrid’’ ap- netic purity and identity. plied to kinds or varieties of seed (ee) Certified seed. Certified seed is a means the first generation seed of a class of certified seed which is the cross produced by controlling the polli- progeny of Breeder, Foundation, or nation and by combining (1) two or Registered seed, except as provided in more inbred lines; (2) one inbred or a § 201.70, and is produced and handled single cross with an open pollinated va- under procedures established by the riety; or (3) two selected clones, seed certifying agency, in accordance with lines, varieties, or species. ‘‘Control- this part, for producing the Certified ling the pollination’’ means to use a class of seed, for the purpose of main- method of hybridization which will taining genetic purity and identity. produce pure seed which is at least 75 (ff) Off-type. The term ‘‘off-type’’ percent hybrid seed. Hybrid designa- means a plant or seed which deviates in tions shall be treated as variety names. one or more characteristics from that (z) Processing. For the purpose of sec- which has been described in accordance tion 203 (b)(2)(C) of the act the term with § 201.68(c) as being usual for the ‘‘processing’’ means cleaning, scari- strain or variety. fying, or blending to obtain uniform (gg) Inbred line. The term ‘‘inbred quality, and other operations which line’’ means a relatively true-breeding would change the purity or germina- strain resulting from at least five suc- tion of the seed and therefore require cessive generations of controlled self-
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fertilization or of backcrossing to a re- each lot of such seed so transported or current parent with selection, or its delivered, including a sample rep- equivalent, for specific characteristics. resenting each lot of such seed, except (hh) Single cross. The term ‘‘single that any seed sample may be discarded cross’’ means the first generation hy- 1 year after the entire lot represented brid between two inbred lines. by such sample has been disposed of by (ii) Foundation single cross. The term such person. ‘‘foundation single cross’’ means a sin- (b) Each sample of agricultural seed gle cross used in the production of a retained shall be at least the weight re- double cross, a three-way, or a top quired for a noxious-weed seed exam- cross. ination as set forth in § 201.46 and each (jj) Double cross. The term ‘‘double sample of vegetable seed retained shall cross’’ means the first generation hy- consist of at least 400 seeds. The record brid between two single crosses. shall be kept in such manner as to per- (kk) Top cross. The term ‘‘top cross’’ mit comparison with the records re- means the first generation hybrid of a quired to be kept by other persons for cross between an inbred line and an the same lot of seed so that the origin, open-pollinated variety or the first- treatment, germination, and purity generation hybrid between a single (including variety) of agricultural seed cross and an open-pollinated variety. and the treatment, germination and (ll) Three-way cross. The term ‘‘three- variety of vegetable seed may be traced way cross’’ means a first generation from the grower to the ultimate con- hybrid between a single cross and an sumer and so that the lot of seed may inbred line. be correctly labeled. The record shall (mm) Open-pollination. The term be accessible for inspection by the au- ‘‘open-pollination’’ means pollination thorized agents of the Secretary for that occurs naturally as opposed to purposes of the effective administra- controlled pollination, such as by tion of the act at any time during cus- detasselling, cytoplasmic male ste- tomary business hours. rility, self-incompatibility or similar processes. [24 FR 3951, May 15, 1959, as amended at 32 FR 12778, Sept. 6, 1967] [5 FR 28, Jan. 4, 1940] § 201.5 Origin. EDITORIAL NOTE: For Federal Register cita- tions affecting § 201.2, see the List of CFR (a) The complete record for any lot of Sections Affected, which appears in the seed of alfalfa, red clover, white clover, Finding Aids section of the printed volume or field corn, except hybrid seed corn, and on GPO Access. shall include a declaration of origin, or information traceable to a declaration ADMINISTRATION of origin or evidence showing that a § 201.3 Administrator. declaration of origin could not be ob- tained. The Administrator of the Agricul- (b) Each country shipper shall retain tural Marketing Service may perform a copy of each declaration which he such duties as the Secretary require in issues and shall attach thereto a de- enforcing the provisions of the act and tailed record showing the names and of the regulations in this part. addresses of growers or country ship- [5 FR 30, Jan. 4, 1940, as amended at 13 FR pers from whom the seed was pur- 8731, Dec. 30, 1948; 19 FR 57, Jan. 6, 1954; 59 FR chased, the quantity of seed purchased 66491, Dec. 14, 1994] from each, and the date on which it was delivered to him. RECORDS FOR AGRICULTURAL AND VEGETABLE SEEDS [5 FR 30, Jan. 4, 1940, as amended at 20 FR 7929, Oct. 21, 1955] § 201.4 Maintenance and accessibility. (a) Each person transporting or deliv- § 201.6 Germination. ering for transportation in interstate The complete record shall include commerce agricultural or vegetable the records of all laboratory tests for seed subject to the act shall keep for a germination and hard seed for each lot period of 3 years a complete record of of seed offered for transportation in
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whole or in part. The record shall show contain information in addition to that the kind of seed, lot number, date of required by the act, provided such in- test, percentage of germination and formation is not misleading. hard seeds, and such other information as may be necessary to show the meth- [5 FR 30 Jan. 4, 1940, as amended at 24 FR od used. 3952, May 15, 1959] [5 FR 30, Jan. 4, 1940] § 201.9 Kind. § 201.7 Purity (including variety). The name of each kind of seed present in excess of 5 percent shall be The complete record for any lot of shown on the label and need not be ac- seed shall include (a) records of anal- companied by the word ‘‘kind.’’ When yses, tests, and examinations including two or more kinds of seed are named on statements of weed seeds, noxious weed seeds, inert matter, other agricultural the label, the name of each kind shall seeds, and of any determinations of be accompanied by the percentage of kind, variety, or type and a description each. When only one kind of seed is of the methods used; and (b) for seeds present in excess of 5 percent and no indistinguishable by seed characteris- variety name or type designation is tics, records necessary to disclose the shown, the percentage of that kind kind, variety, or type, including a may be shown as ‘‘pure seed’’ and such grower’s declaration of kind, variety, percentage shall apply only to seed of or type or an invoice, or other docu- the kind named. ment establishing the kind, variety, or [5 FR 30, Jan. 4, 1940] type to be that stated, and a represent- ative sample of the seed. The grower’s § 201.10 Variety. declaration shall be obtained and kept by the person procuring the seed from (a) The following kinds of agricul- the grower. A copy of the grower’s dec- tural seeds are generally labeled as to laration and a sample of the seed shall variety and shall be labeled to show be retained by the grower. the variety name or the words ‘‘Vari- ety Not Stated.’’ [5 FR 30, Jan. 4, 1940, as amended at 20 FR Alfalfa; Bahiagrass; Barley; Bean, field; 7929, Oct. 21, 1955; 24 FR 3951, May 15, 1959] Beet, field; Brome, smooth; Broomcorn; Clo- § 201.7a Treated seed. ver, crimson; Clover, red; Clover, white; Corn, field; Corn, pop; Cotton; Cowpea; The complete record for any lot con- Crambe; Fescue, tall; Flax; Lespedeza, stri- sisting of or containing treated seed ate; Millet, foxtail; Millet, pearl; Oat; Pea, shall include records necessary to dis- field; Peanut; Rice; Rye; Safflower; Sor- close the name of any substance or sub- ghum; Sorghum-sudangrass, Soybean; stances used in the treatment of such Sudangrass; Sunflower; Tobacco; Trefoil, seed, including a label or invoice or birdsfoot; Triticale; Wheat, common; Wheat, other document received from any per- durum. son establishing the name of any sub- (b) If the name of the variety is stance or substances used in the treat- given, the name may be associated ment to be as stated, and a representa- with the name of the kind with or tive sample of the treated seed. without the words ‘‘kind and variety.’’ The percentage in such case, which [32 FR 12778, Sept. 6, 1967] may be shown as ‘‘pure seed,’’ shall LABELING AGRICULTURAL SEEDS apply only to seed of the variety named, except for the labeling of hy- § 201.8 Contents of the label. brids as provided in § 201.11a. If sepa- The label shall contain the required rate percentages for the kind and the information in any form that is clearly variety or hybrid are shown, the name legible and complies with the regula- of the kind and the name of the variety tions in this part. The information or the term ‘‘hybrid’’ shall be clearly may be on a tag attached securely to associated with the respective percent- the container, or may be printed in a ages. When two or more varieties are conspicuous manner on a side or the present in excess of 5 percent and are top of the container. The label may named on the label, the name of each
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variety shall be accompanied by the cent hybrid seed as a result of incom- percentage of each. pletely controlled pollination in a cross shall be labeled to show (a) the [32 FR 12778, Sept. 6, 1967, and 33 FR 10840, July 31, 1968, as amended at 35 FR 6108, Apr. percentage of pure seed that is hybrid 15, 1970; 59 FR 64491, Dec. 14, 1994] seed or (b) a statement such as ‘‘Con- tains from 75 percent to 95 percent hy- § 201.11 Type. brid seed.’’ No one kind or variety of (a) When type is designated, such des- seed shall be labeled as hybrid if the ignation may be associated with the pure seed contains less than 75 percent name of the kind but shall in all cases hybrid seed. be clearly associated with the word [33 FR 10840, July 31, 1968] ‘‘type.’’ The percentage, which may be shown as ‘‘pure seed’’, shall apply only § 201.12 Name of kind and variety. to the type designated. If separate per- The representation of kind or kind centages for the kind and the type are and variety shall be confined to the shown, such percentages shall be clear- name of the kind or kind and variety ly associated with the name of the kind determined in accordance with § 201.34. and the name of the type. The name shall not have affixed there- (b) If the type designation does not to words or terms that create a mis- include a variety name, it shall include leading impression as to the history or a name descriptive of a group of vari- characteristics of the kind or variety. eties of similar character and the pure seed shall be at least 90 percent of one [20 FR 7929, Oct. 21, 1955] or more varieties all of which conform § 201.12a Lawn and turf seed mixtures. to the type designation. (c) If the name of a variety is used as Seed mixtures intended for lawn and a part of the type designation, the seed turf purposes shall be designated as a shall be of that variety and may con- mixture on the label and each seed tain: (1) An admixture of seed of other component shall be listed on the label indistinguishable varieties of the same in the order of predominance. kind and of similar character; or, (2) an [49 FR 1172, Jan. 10, 1984] admixture of indistinguishable seeds having genetic characteristics dis- § 201.13 Lot number or other identi- similar to the variety named by reason fication. of cross-fertilization with other vari- The lot number or other identifica- eties. In either case, at least 90 percent tion shall be shown on the label and of the pure seed shall be of the variety shall be the same as that used in the named or upon growth shall produce records pertaining to the same lot of plants having characteristics similar seed. to the variety named. [5 FR 30, Jan. 4, 1940, as amended at 59 FR [5 FR 30, Jan. 4, 1940] 64491, Dec. 14, 1994]
§ 201.11a Hybrid. § 201.14 Origin. If any one kind or kind and variety of (a) Alfalfa, red clover, white clover, seed present in excess of 5 percent is and field corn (except hybrid seed corn) ‘‘hybrid’’ seed, it shall be designated shall be labeled to show: (1) The origin, ‘‘hybrid’’ on the label. The percentage if known; or (2) if the origin is not that is hybrid shall be at least 95 per- known, the statement ‘‘origin un- cent of the percentage of pure seed known.’’ shown unless the percentage of pure (b) Whenever such seed originates in seed which is hybrid seed is shown sep- more than one State, the name of each arately. If two or more kinds or vari- State and the percentage of seed origi- eties are present in excess of 5 percent nating in each State shall be given in and are named on the label, each that the order of its predominance. When- is hybrid shall be designated as hybrid ever such seed originates in a portion on the label. Any one kind or kind and of a State, it shall be permissible to variety that has pure seed which is less label such seed as originating in such than 95 percent but more than 75 per- portion of a State.
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(c) Reasonable precautions to insure Ageratina adenophora (Spreng.) King and H.E. that the origin of seed is known shall Robins. include the maintaining of a record as Alectra spp. described in § 201.5. The examination of Alternanthera sessilis (L.) DC. Asphodelus fistulosus L. the seed and any pertinent facts may Avena sterilis L. (including Avena ludoviciana be taken into consideration in deter- Dur.) mining whether reasonable precautions Azolla pinnata R. Br. have been taken to insure the origin to Borreria alata (Aubl.) DC. be that which is represented. Carthamus oxyacantha M. Bieb. Chrysopogon aciculatus (Retz.) Trin. [5 FR 31, Jan. 4, 1940, as amended at 20 FR Commelina benghalensis L. 7929, Oct. 21, 1955; 32 FR 12779, Sept. 6, 1967] Crupina vulgaris Cass. Digitaria abyssinica Stapf.(=D. scalarum § 201.15 Weed seeds. (Schweinf.) Chiov.) Digitaria velutina (Forsk.) Beauv. The percentage of weed seeds shall Drymaria arenarioides Roem. and Schult. include seeds of plants considered Eichornia azurea (Sw.) Kunth weeds in the State into which the seed Emex australis Steinh. is offered for transportation or trans- Emex spinosa (L.) Campd. ported and shall include noxious weed Galega officinalis L. seeds. Heracleum mantegazzianum Sommier & Levier Hydrilla verticillata (L. f.) Royle [5 FR 31, Jan. 4, 1940] Hygrophila polysperma T. Anders. Imperata brasiliensis Trin. § 201.16 Noxious-weed seeds. Imperata cylindrica (L.) Raeusch. Ipomoea aquatica Forsk. (a) Except for those kinds of noxious- Ipomoea triloba L. weed seeds shown in paragraph (b) of Ischaemum rugosum Salisb. this section, the names of the kinds of Lagarosiphon major (Ridley) Moss noxious-weed seeds and the rate of oc- Leptochloa chinensis (L.) Nees currence of each shall be expressed in Limnophila sessiliflora (Vahl) Blume the label in accordance with, and the Lycium ferocissimum Miers Melaleuca quinquenervia (Cav.) Blake rate of occurrence shall not exceed the Melastoma malabathricum L. rate permitted by, the law and regula- Mikania cordata (Burm. f.) B.L. Robins. tions of the state into which the seed is Mikania micrantha H.B.K. offered for transportation or is trans- Mimosa invisa Mart. ported. If in the course of such trans- Mimosa pigra L. var. pigra portation, or thereafter, the seed is di- Monochoria hastata (L.) Sloms-Laub. verted to another State of destination, Monochoria vaginalis (Burm. f.) K.B. Presl Nassella trichotoma (Nees) Arechavaleta the person or persons responsible for Opuntia aurantiaca Lindl. such diversion shall cause the seed to Orobanche spp. be relabeled with respect to the nox- Oryza longistaminata A. Cheval. and Roehr. ious-weed seed content, if necessary to Oryza punctata Steud. conform to the laws and regulations of Oryza rufipogon Griff. the State into which the seed is di- Ottelia alismoides (L.) Pers. verted. Paspalum scrobiculatum L. Pennisetum clandestinum Chiov. (b) Seeds or bulblets of the following Pennisetum macrourum Trin. plants shall be considered noxious-weed Pennisetum pedicellatum Trin. seeds in agricultural and vegetable Pennisetum polystachion (L.) Schult. seeds transported or delivered for Prosopis alapataco R.A. Philippi transportation in interstate commerce Prosopis argentina Burkart (including Puerto Rico, Guam, and the Prosopis articulata S. Watson District of Columbia). Agricultural or Prosopis burkartii Munoz Prosopis caldenia Burkart vegetable seed containing seeds or Prosopis calingastana Burkart bulblets of these kinds shall not be Prosopis campestris Griseb. transported or delivered for transpor- Prosopis castellanosii Burkart tation in interstate commerce. Nox- Prosopis denudans Benth. ious-weed seeds include the following Prosopis elata (Burkart) Burkart species on which no tolerance will be Prosopis farcta (Russell) Macbride applied: Prosopis ferox Griseb. Prosopis fiebrigii Harms Aeginetia spp. Prosopis hassleri Harms
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Prosopis humilis Hook. and Arn. eties, or types not named upon the Prosopis kuntzei Harms label. Prosopis pallida (Willd.) H.B.K. Prosopis palmeri S. Watson [5 FR 31, Jan. 4, 1940] Prosopis reptans Benth. var. reptans Prosopis rojasiana Burkart § 201.19 Inert matter. Prosopis ruizlealii Burkart The label shall show the percentage Prosopis ruscifolia Griseb. Prosopis sericantha Hook. and Arn. by weight of inert matter. Prosopis strombulifera (Lam.) Benth. [5 FR 31, Jan. 4, 1940] Prosopis torquata (Lagasca) DC. Rottboellia cochinchinensis (Lour.) Clayton § 201.20 Germination. (=R. exaltata (L.) L.f.) Rubus fruticosus L. (complex) The label shall show the percentage Rubus moluccanus L. of germination each kind, or kind and Saccharum spontaneum L. variety, or kind and type, or kind and Sagittaria sagittifolia L. hybrid of agricultural seed present in Salsola vermiculata L. excess of 5 percent or shown in the la- Salvinia auriculata Aubl. beling to be present in a proportion of Salvinia biloba Raddi Salvinia herzogii de la Sota 5 percent or less: Provided, That this Salvinia molesta D.S. Mitchell shall not apply to freshly harvested Setaria pallide-fusca (Schumach.) Stapf and Kentucky bluegrass or sugar beet seed Hubb. transported or delivered for transpor- Solanum torvum Sw. tation during the months of July, Au- Solanum viarum Dunal gust, and September for seeding during Sparaganium erectum L. the year in which the seed is produced. Striga spp. Tridax procumbens L. [24 FR 3953, May 15, 1959, as amended at 32 Urochloa panicoides Beauv. FR 12779, Sept. 6, 1967; 59 FR 64491, Dec. 14, [65 FR 1706, Jan. 11, 2000] 1994] EFFECTIVE DATE NOTE: At 65 FR 1706, Jan. § 201.21 Hard seed. 11, 2000, § 201.16 was revised, effective Jan. 11, 2000, except for paragraph (b), which is not The label shall show the percentage effective until Jan. 11, 2001. of hard seed, if any is present, for any seed required to be labeled as to the § 201.17 Noxious-weed seeds in the Dis- percentage of germination, and the per- trict of Columbia. centage of hard seed shall not be in- (a) Noxious-weed seeds in the District cluded as part of the germination per- of Columbia are: Quackgrass (Elytrigia centage. repens), Canada thistle (Cirsium [24 FR 3953, May 15, 1959] arvense), field bindweed (Convolvulus arvensis), bermudagrass (Cynodon § 201.22 Date of test. dactylon), giant bermudagrass (Cynodon (a) The label shall show the month dactylon var. aridus), annual bluegrass and year in which the germination test (Poa annua), and wild garlic or wild was completed. No more than 5 cal- onion (Allium canadense or Allium endar months shall have elapsed be- vineale). The name and number per tween the last day of the month in pound of each kind of such noxious- which the germination test was com- weed seeds present shall be stated on pleted and the date of transportation the label. or delivery for transportation in inter- (b) [Reserved] state commerce, except for seed in her- [65 FR 1707, Jan. 11, 2000] metically sealed containers as provided in § 201.36c in which case no more than § 201.18 Other agricultural seeds (crop 24 calendar months shall have elapsed seeds). between the last day of the month in Agricultural seeds other than those which the germination test was com- included in the percentage or percent- pleted prior to packaging and the date ages of kind, variety, or type may be of transportation or delivery for trans- expressed as ‘‘crop seeds’’ or ‘‘other portation in interstate commerce. crop seeds,’’ but the percentage shall (b) In the case of a seed mixture, it is include collectively all kinds, vari- only necessary to state the calendar
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month and year of such test for the claimed to be effective kind or variety or type of agricultural afterllll(Month and year).’’ seed contained in such mixture which has the oldest calendar month and year [32 FR 12779, Sept. 6, 1967] test date among the test conducted on LABELING VEGETABLE SEEDS all the kinds or varieties or types of agricultural seed contained in such § 201.25 Contents of the label. mixture. (c) The following kinds shall be test- Vegetable seed in packets and in ed within the indicated time before larger containers shall be labeled with interstate shipment: the required information in any form that is clearly legible. Any tag used Months shall be securely attached to the con- from test Agricultural seeds and mixtures thereof date to tainer. The label may contain informa- shipment tion in addition to that required by the act, provided such information is not Bentgrass, Colonial ...... 15 Bentgrass, Creeping ...... 15 misleading. Bluegrass, Kentucky ...... 15 Fescue, Chewings ...... 15 [5 FR 31, Jan. 4, 1940] Fescue, Hard ...... 15 Fescue, Red ...... 15 § 201.26 Kind, variety, and hybrid. Fescue, Tall ...... 15 Ryegrass, Annual ...... 15 The label shall bear the name of each Ryegrass, Perennial ...... 15 kind and variety present as determined in accordance with § 201.34. The name [5 FR 31, Jan. 4, 1940, as amended at 32 FR shall not have affixed thereto words or 12779, Sept. 6, 1967; 49 FR 1172, Jan. 10, 1984; terms that create a misleading impres- 59 FR 64491, Dec. 14, 1994] sion as to the history or characteris- tics of kind or variety. If two or more § 201.23 Name of shipper or consignee. kinds or varieties are present, the per- The full name and address of either centage of each shall be shown. If any the shipper or consignee shall appear one kind or variety named on the label upon the label. If the name and address is ‘‘hybrid’’ seed, it shall be so des- of the shipper are not shown upon the ignated on the label. If two or more label, a code designation identifying kinds or varieties are named on the the shipper shall be shown. label, each that is hybrid shall be shown as ‘‘hybrid’’ on the label. Any [5 FR 31, Jan. 4, 1940] kind or variety that is less than 95 per- § 201.24 Code designation. cent but more than 75 percent hybrid seed as a result of incompletely con- The code designation used in lieu of trolled pollination in a cross shall be the full name and address of the person labeled to show (a) the percentage that who transports or delivers seed for is hybrid seed or (b) a statement such transportation in interstate commerce as ‘‘Contains from 75 percent to 95 per- shall be approved by the Administrator cent hybrid seed.’’ No one kind or vari- of the Agricultural Marketing Service ety of seed shall be labeled as hybrid if or such other person as may be des- it contains less than 75 percent hybrid ignated by him for the purpose. When seed. used, the code designation shall appear on the label in a clear and legible man- [33 FR 10841, July 31, 1968, as amended at 59 ner. FR 64491, Dec. 14, 1994] [5 FR 31, Jan. 4, 1940, as amended at 13 FR § 201.27 Name of shipper or consignee. 8731, Dec. 30, 1948; 19 FR 57, Jan. 6, 1954] The full name and address of either § 201.24a Inoculated seed. the shipper, or consignee, shall appear upon the label except that if the name Seed claimed to be inoculated shall and address of the shipper are not be labeled to show the month and year shown, a code designation identifying beyond which the inoculant on the seed the shipper shall be shown. is no longer claimed to be effective by a statement such as, ‘‘Inoculant not [5 FR 31, Jan. 4, 1940]
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§ 201.28 Code designation. § 201.30a Date of test. The code designation used in lieu of When the percentage of germination the full name and address of the person is required to be shown, the label shall who transports or delivers seed for show the month and year in which the transportation in interstate commerce germination test was completed. No shall be approved by the Administrator more than 5 calendar months shall of the Agricultural Marketing Service have elapsed between the last day of or such other person as may be des- the month in which the germination ignated by him for the purpose. When test was completed and the date of used, the code designation shall appear transportation or delivery for transpor- on the label in a clear and legible man- tation in interstate commerce, except ner. for seed in hermetically sealed con- tainers in which case no more than 24 [5 FR 31, Jan. 4, 1940, as amended at 13 FR calendar months shall have elapsed be- 8731, Dec. 30, 1948; 19 FR 57, Jan. 6, 1954] tween the last day of the month in which the germination test was com- § 201.29 Germination of vegetable seed pleted prior to packaging and the date in containers of 1 pound or less. of transportation or delivery for trans- Vegetable seeds in containers of 1 portation in interstate commerce. pound or less which have a germination [32 FR 12779, Sept. 6, 1967] equal to or better than the standard set forth in § 201.31 need not be labeled to § 201.30b Lot number or other lot iden- show the percentage of germination tification of vegetable seed in con- and date of test. Each variety of vege- tainers of more than 1 pound. table seed which has a germination The lot number or other lot identi- percentage less than the standard set fication of vegetable seed in containers forth in § 201.31 shall have the words of more than 1 pound shall be shown on ‘‘Below Standard’’ clearly shown in a the label and shall be the same as that conspicuous place on the label or on used in the records pertaining to the the face of the container in type no same lot of seed. smaller than 8 points. Each variety [35 FR 6108, Apr. 15, 1970] which germinates less than the stand- ard shall also be labeled to show the § 201.31 Germination standards for percentage of germination and the per- vegetable seeds in interstate com- centage of hard seed (if any). merce. [32 FR 12779, Sept. 6, 1967] The following germination standards for vegetable seeds in interstate com- § 201.29a Germination of vegetable merce, which shall be construed to in- seed in containers of more than 1 clude hard seed, are determined and es- pound. tablished under section 403(c) of the Each variety of vegetable seeds in act: containers of more than 1 pound shall Percent be labeled to show the percentage of germination and the percentage of hard Artichoke ...... 60 Asparagus ...... 70 seed (if any). Asparagusbean ...... 75 Bean, garden ...... 70 [32 FR 12779, Sept. 6, 1967] Bean, lima ...... 70 Bean, runner ...... 75 § 201.30 Hard seed. Beet ...... 65 Broadbean ...... 75 The label shall show the percentage Broccoli ...... 75 of hard seed, if any is present, for any Brussels sprouts ...... 70 Burdock, great ...... 60 seed required to be labeled as to the Cabbage ...... 75 percentage of germination, and the per- Cabbage, tronchuda ...... 70 centage of hard seed shall not be in- Cardoon ...... 60 Carrot ...... 55 cluded as part of the germination per- Cauliflower ...... 75 centage. Celeriac ...... 55 Celery ...... 55 [32 FR 12779, Sept. 6, 1967] Chard, Swiss ...... 65
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Percent Treated with llllllllll (name of substance or process) or llllllllll Chicory ...... 65 (name of substance or process) treated. Chinese cabbage ...... 75 Chives ...... 50 If the substance used in such treatment Citron ...... 65 in the amount remaining with the seed Collards ...... 80 is harmful to humans or other Corn, sweet ...... 75 vertebrate animals, the seed shall also Cornsalad ...... 70 Cowpea ...... 75 bear a label containing additional Cress, garden ...... 75 statements as required by paragraphs Cress, upland ...... 60 (c) and (d) of this section. The label Cress, water ...... 40 shall contain the required information Cucumber ...... 80 Dandelion ...... 60 in any form that is clearly legible and Dill ...... 60 complies with the regulations in this Eggplant ...... 60 part. The information may be on the Endive ...... 70 tag bearing the analysis information or Kale ...... 75 Kale, Chinese ...... 75 on a separate tag, or it may be printed Kale, Siberian ...... 75 in a conspicuous manner on a side or Kohlrabi ...... 75 top of the container. Leek ...... 60 (b) Name of substance. The name of Lettuce ...... 80 Melon ...... 75 any substance as required by paragraph Mustard, India ...... 75 (a) of this section shall be the com- Mustard, spinach ...... 75 monly accepted coined, chemical (ge- Okra ...... 50 neric), or abbreviated chemical name. Onion ...... 70 Onion, Welsh ...... 70 Commonly accepted coined names are Pak-choi ...... 75 free for general use by the public, are Parsley ...... 60 not private trade-marks, and are com- Parsnip ...... 60 monly recognized as names of par- Pea ...... 80 Pepper ...... 55 ticular substances; such as thiram, Pumpkin ...... 75 captan, lindane, and dichlone. Exam- Radish ...... 75 ples of commonly accepted chemical Rhubarb ...... 60 (generic) names are: blue- stone, cal- Rutabaga ...... 75 Sage ...... 60 cium carbonate, cuprous oxide, zinc hy- Salsify ...... 75 droxide, hexachlorobenzene, and ethyl Savory, summer ...... 55 mercury acetate. The terms ‘‘mercury’’ Sorrel ...... 65 Soybean ...... 75 or ‘‘mercurial’’ may be used in labeling Spinach ...... 60 all types of mercurials. Examples of Spinach, New Zealand ...... 40 commonly accepted abbreviated chem- Squash ...... 75 ical names are: BHC (1, 2, 3, 4, 5, 6- Tomato ...... 75 Tomato, husk ...... 50 Hexachlorocyclohexane) and DDT Turnip ...... 80 (dichloro diphenyl trichloroethane). Watermelon ...... 70 (c) Mercurials and similarly toxic sub- stances. (1) Seed treated with a mer- [59 FR 64491, Dec. 14, 1994] curial or similarly toxic substance, if any amount remains with the seed, LABELING IN GENERAL shall be labeled to show a representa- tion of a skull and crossbones at least § 201.31a Labeling treated seed. twice the size of the type used for in- (a) Contents of label. Any agricultural formation required to be on the label seed or any mixture thereof or any veg- under paragraph (a) and shall also in- etable seed or any mixture thereof, for clude in red letters on a background of seeding purposes, that has been treated distinctly contrasting color a state- shall be labeled in type no smaller than ment worded substantially as follows: 8 point to indicate that the seed has ‘‘This seed has been treated with Poi- been treated and to show the name of son,’’ ‘‘Treated with Poison,’’ ‘‘Poison any substance or a description of any treated,’’ or ‘‘Poison’’. The word ‘‘Poi- process (other than application of a son’’ shall appear in type no less than substance) used in such treatment, in 8 point. accordance with this section; for exam- (2) Mercurials and similarly toxic ple, substances include the following:
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Aldrin, technical in bulk, shall be invoiced with the Demeton words, ‘‘Screenings for processing—not Dieldrin for seeding.’’ p-Dimethylaminobenzenediazo sodium sulfonate [5 FR 31, Jan. 4, 1940] Endrin Ethion § 201.33 Seed in bulk or large quan- Heptachlor tities; seed for cleaning or proc- Mercurials, all types essing. Parathion (a) In the case of seed in bulk, the in- Phorate formation required under sections Toxaphene O - O - Diethyl-O-(isopropyl-4-methyl-6-py- 201(a), (b), and (i) of the act shall ap- rimidyl) thiophosphate pear in the invoice or other records ac- O, O-Diethyl-S-2-(ethylthio) ethyl companying and pertaining to such phosphorodithioate seed. If the seed is in containers and in Any amount of such substances re- quantities of 20,000 pounds or more, re- maining with the seed is considered gardless of the number of lots included, harmful within the meaning of this the information required on each con- section. tainer under sections 201 (a), (b), and (i) (d) Other harmful substances. If a sub- of the act need not be shown on each stance, other than one which would be container; Provided, That: (1) The omis- classified as a mercurial or similarly sion from each container of a label toxic substance under paragraph (c) of with the required information is with this section, is used in the treatment of the knowledge and consent of the con- seed, and the amount remaining with signee prior to the transportation or the seed is harmful to humans or other delivery for transportation of such seed vertebrate animals, the seed shall be in interstate commerce; (2) each con- labeled with an appropriate caution tainer has stenciled upon it or bears a statement in type no smaller than 8 label containing a lot designation; and point worded substantially as follows: (3) the invoice or other records accom- ‘‘Do not use for food,’’ ‘‘Do not use for panying and pertaining to such seed feed,’’ ‘‘Do not use for oil purposes,’’ or bear the various statements required ‘‘Do not use for food, feed, or oil pur- for the respective seeds. poses.’’ Any amount of any substance, (b) Seed consigned to a seed cleaning not within paragraph (c) of this sec- or processing establishment, for clean- tion, used in the treatment of the seed, ing or processing for seeding purposes, which remains with the seed is consid- need not be labeled to show the infor- ered harmful within the meaning of mation required on each container this section when the seed is in con- under sections 201 (a), (b), and (i) of the tainers of more than 4 ounces, except act if it is in bulk, or in containers and that the following substances shall not in quantities of 20,000 pounds or more be deemed harmful when present at a regardless of the number of lots in- rate less than the number of parts per volved, and the invoice or other records million indicated: accompanying and pertaining to such seed show that it is ‘‘Seed for proc- Allethrin—2 p.p.m. Malathion—8 p.p.m. essing,’’ or, if the seed is in containers Methoxyclor—2 p.p.m. and in quantities less than 20,000 Piperonyl butoxide—8 p.p.m. on oat and pounds and each container bears a sorghum and 20 p.p.m. on all other seeds. label with the words ‘‘Seed for proc- Pyrethrins—1 p.p.m. on oat and sorghum essing.’’ If any such seed is later to be and 3 p.p.m. on all other seeds. labeled as to origin and/or variety, the [24 FR 3953, May 15, 1959, as amended at 25 origin and/or variety as the case may FR 8769, Sept. 13, 1960; 30 FR 7888, June 18, be, shall be shown on the invoice if the 1965] seed is in bulk, otherwise, on a label, at the time of transportation to such es- § 201.32 Screenings. tablishment, except that if it is cov- Screenings shipped in interstate ered by a declaration of origin and/or commerce, if in containers, shall be la- variety it will be sufficient if the lot beled in a legible manner with letters designation appearing in the declara- not smaller than 18 point type and, if tion is placed on the invoice if the seed
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is in bulk, or on a label if the seed is in or other characters by which it can be containers, regardless of the quantity. differentiated from other sorts of the same kind. [24 FR 3953, May 15, 1959] (2) Except as otherwise provided in § 201.34 Kind, variety, and type; treat- this section, the name of a new variety ment substances; designation as hy- shall be the name given by the origi- brid. nator or discoverer of the variety, ex- (a) Indistinguishable seed and treat- cept that in the event the originator or ment substances. Reasonable pre- discoverer of a new unnamed variety, cautions to insure that the kind, vari- at the time seed of the variety is first ety, or type of indistinguishable agri- introduced into channels of commerce cultural or vegetable seeds and names of the United States for sale to the of any treatment substance are prop- public, cannot or chooses not to name erly stated shall include the maintain- the variety, the name of the variety ing of the records described in § 201.7 or shall be the first name under which the § 201.7a. The examination of the seed seed is introduced into such commerce. and any pertinent facts may be taken However, if the variety name so pro- into consideration in determining vided is in a language not using the whether reasonable precautions have Roman alphabet, the variety shall be been taken to insure the kind, variety, given a name by the person authorized or type of seed or any treatment sub- under this paragraph to name the vari- stance on the seed is that which is ety, in a language using the Roman al- shown. Reasonable precautions in la- phabet. beling ryegrass seed as to kind shall in- (3) The variety name shall not be clude making or obtaining the results misleading. The same variety name of a fluorescence test unless (1) the shall not be assigned to more than one shortness of the time interval between variety of the same kind of seed. receipt of the seed lot and the ship- (4) The status under the Federal Seed ment of the seed in interstate com- Act of a variety name is not modified merce, or (2) dormancy of the seeds in by the registration of such name as a the lot, or (3) other circumstances be- trademark. yond the control of the shipper prevent (5) Names of varieties which through such action before the shipment is broad general usage prior to July 28, made. Reasonable precautions in label- 1956 were recognized variety names, ex- ing ryegrass seed as to kind shall also cept for hybrid seed corn, shall be con- include keeping separate each lot la- sidered variety names without regard beled on the basis of a separate grow- to the principles stated in paragraph er’s declaration, invoice, or other docu- (d)(2) of this section. ments. (6) The variety name for any variety (b) Name of kind. The name of each of hybrid seed corn first introduced kind of agricultural or vegetable seed into commercial channels in the is the name listed in § 201.2 (h) or (i), re- United States for sale prior to October spectively, except that a name which 20, 1951, shall be any name used for has become synonymous through broad such variety in such channels prior to general usage may be substituted that date. The variety name for any therefor, provided the name does not variety of hybrid seed corn first intro- apply to more than one kind and is not duced into commercial channels in the misleading. United States for sale on or after Octo- (c) Hybrid designation. Seed shall not ber 20, 1951, shall be the name assigned be designated in labeling as ‘‘hybrid’’ in accordance with paragraphs (d)(1) seed unless it comes within the defini- through (4) of this section. tion of ‘‘hybrid’’ in § 201.2(y). (e) [Reserved] (d) Name of variety. The name of each variety of agricultural or vegetable [20 FR 7928, Oct. 21, 1955] seed is the name determined in accord- EDITORIAL NOTE: For Federal Register cita- ance with the following considerations: tions affecting § 201.34, see the List of CFR (1) The variety name shall represent Sections Affected, which appears in the a subdivision of a kind, which is char- Finding Aids section of the printed volume acterized by growth, plant, fruit, seed, and on GPO Access.
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§ 201.35 Blank spaces. variety; for example, Oshkosh pepper Blank spaces on the label shall be (yellow), Copenhagen Market (round deemed to imply the word ‘‘None,’’ head) cabbage, and Kentucky Wonder when such interpretation is reasonable. (pole) garden bean. (c) Terms descriptive of quality or [5 FR 32, Jan. 4, 1940] origin and terms descriptive of the basis for representations made may be § 201.36 The words ‘‘free’’ and ‘‘none.’’ associated with the name of the kind The words ‘‘free’’ and ‘‘none’’ shall be or variety: Provided, That the terms construed to mean that none were are clearly identified as being other found in a test complying with the than part of the name of the kind or methods set forth in §§ 201.45–201.52. variety; for example, Fancy quality [5 FR 32, Jan. 4, 1940] redtop, Idaho origin alfalfa, and Grow- er’s affidavit of variety Atlas sorghum. MODIFYING STATEMENTS (d) Terms descriptive of the manner or method of production or processing § 201.36a Disclaimers and nonwarran- the seed (for example, certified, reg- ties. istered, delinted, scarified, treated, and A disclaimer, nonwarranty, or lim- hulled), may be associated with the ited warranty used in any invoice or name of the kind or variety of seed, other labeling, or advertisement shall providing such terms are not mis- not directly or indirectly deny or mod- leading. ify any information required by the act (e) Brand names and terms taken or the regulations in this part. from trademarks may be associated with the name of the kind or variety of [15 FR 2394, Apr. 28, 1950] seed as an indication of source: Pro- ADVERTISING vided, That the terms are clearly iden- tified as being other than a part of the § 201.36b Name of kind and variety; name of the kind or variety; for exam- designation as hybrid. ple, Ox Brand Golden Cross sweet corn. (a) The representation of the name of Seed shall not be advertised under a a kind or kind and variety of seed in trademark or brand name in any man- any advertisement subject to the act ner that may create the impression shall be confined to the name of the that the trademark or brand name is a kind or kind and variety determined in variety name. If seed advertised under accordance with § 201.34. The name a trademark or brand name is a mix- shall not have associated therewith ture of varieties and if the variety words or terms that create a mis- names are not stated in the adver- leading impression as to the history or tising, a description similar to a vari- characteristics of the kind or kind and etal description or a comparison with a variety. Descriptive terms and firm named variety shall not be used if it names may be used in kind or variety creates the impression that the seed is names provided the descriptive terms of a single variety. or firm names are a part of the name or [21 FR 4652, June 27, 1956, as amended at 32 variety of seed; for example, Stringless FR 12780, Sept. 6, 1967; 59 FR 64491, Dec. 14, Green Pod, Detroit Dark Red, Black 1994] Seeded Simpson and Henderson Bush Lima. Seed shall not be designated as § 201.36c Hermetically-sealed con- hybrid seed in any advertisement sub- tainers. ject to the act unless it comes within The 5-month limitation on the date the definition of ‘‘hybrid’’ in § 201.2(y). of test in §§ 201.22 and 201.30a shall not (b) Terms descriptive as to color, apply when the following conditions shape, size, habit of growth, disease-re- have been met: sistance, or other characteristics of the (a) The seed was packaged within 9 kind or variety may be associated with months after harvest; the name of the kind or variety pro- (b) The container used does not allow vided it is done in a manner which water vapor penetration through any clearly indicates the descriptive term wall, including the seals, greater than is not a part of the name of the kind or 0.05 grams of water per 24 hours per 100
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square inches of surface at 100 °F. with content, and (3) the calendar month a relative humidity on one side of 90 and year in which the germination test percent and on the other side of 0 per- was completed. cent. Water vapor penetration or WVP (e) The percentage of germination of is measured by the standards of the vegetable seed at the time of pack- U.S. Bureau of Standards as: aging was equal to or above the stand- ards in § 201.31. gm.H2 O/24 hr./100 sq. in./100 °F./90% RH V.0% RH; [32 FR 12780, Sept. 6, 1967, as amended at 59 FR 64491, Dec. 14, 1994] (c) The seed in the container does not exceed the percentage of moisture, on a INSPECTION wet weight basis, as listed below: § 201.37 Authorization. Agricultural seeds Percent When authorized by the Adminis- Beet, field ...... 7.5 trator of the Agriculture Marketing Beet, sugar ...... 7.5 Service, or by such other person as Bluegrass, Kentucky ...... 6.0 Clover, crimson ...... 8.0 may be designated for the purpose, Fescue, red ...... 8.0 Federal employees and qualified State Mustard, India ...... 5.0 officials, for the purposes of the act, Ryegrass, annual ...... 8.0 Ryegrass, perennial ...... 8.0 may draw samples of, secure informa- All others ...... 6.0 tion and inspect records pertaining to, and otherwise inspect seeds and Vegetable seeds Percent screenings subject to the act.
Bean, garden ...... 7.0 [15 FR 2394, Apr. 28, 1950, as amended at 59 Bean, lima ...... 7.0 FR 64492, Dec. 14, 1994] Beet ...... 7.5 Broccoli ...... 5.0 § 201.38 Importations. Brussels sprouts ...... 5.0 Cabbage ...... 5.0 Prior to release into the commerce of Cabbage, Chinese ...... 5.0 the United States, imported seed and Carrot ...... 7.0 Cauliflower ...... 5.0 screenings shall be inspected as pro- Celeriac ...... 7.0 vided in §§ 361.4 of this title. Celery ...... 7.0 Chard, Swiss ...... 7.5 [5 FR 32, Jan. 4, 1940, as amended at 62 FR Chives ...... 6.5 48459, Sept. 16, 1997] Collards ...... 5.0 Corn, sweet ...... 8.0 Cucumber ...... 6.0 SAMPLING IN THE ADMINISTRATION OF Eggplant ...... 6.0 THE ACT Kale ...... 5.0 Kohlrabi ...... 5.0 § 201.39 General procedure. Leek ...... 6.5 Lettuce ...... 5.5 (a) In order to secure a representa- Melon ...... 6.0 tive sample, equal portions shall be Mustard, India ...... 5.0 Onion ...... 6.5 taken from evenly distributed parts of Onion, Welsh ...... 6.5 the quantity of seed or screenings to be Parsley ...... 6.5 sampled. Access shall be had to all Parsnip ...... 6.0 parts of that quantity. When more than Pea ...... 7.0 Pepper ...... 4.5 one trierful of seed is drawn from a Pumpkin ...... 6.0 bag, different paths shall be followed. Radish ...... 5.0 When more than one handful is taken Rutabaga ...... 5.0 Spinach ...... 8.0 from a bag, the handfuls shall be taken Squash ...... 6.0 from well-separated points. Tomato ...... 5.5 (b) For free-flowing seed in bags or Turnip ...... 5.0 Watermelon ...... 6.5 bulk, a probe or trier shall be used. For All others ...... 6.0 small free-flowing seed in bags a probe or trier long enough to sample all por- (d) The container is conspicuously la- tions of the bag should be used. beled in not less than 8 point type to (c) Non-free-flowing seed, such as cer- indicate (1) that the container is her- tain grass seed, uncleaned seed, or metically sealed, (2) that the seed has screenings, difficult to sample with a been preconditioned as to moisture proble or trier, shall be sampled by
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thrusting the hand into the bulk and § 201.42 Small containers. withdrawing representative portions. In sampling seed in small containers The hand is inserted in an open posi- that it is not practical to sample as re- tion and the fingers are held closely to- quired in § 201.41, a portion of one un- gether while the hand is being inserted opened container or one or more entire and the portion withdrawn. unopened containers may be taken to (d) As the seed or screenings are sam- supply a minimum size sample, as re- pled, each portion shall be examined. If quired in § 201.43. there appears to be a lack of uni- formity, the portions shall not be com- [30 FR 7888, June 18, 1965] bined into a composite sample but shall be retained as separate samples § 201.43 Size of sample. or combined to form individual-con- The following are minimum sizes of tainer samples to determine such lack samples of agricultural seed, vegetable of uniformity as may exist. seed and screenings to be submitted for (e) When the portions appear to be analysis, test, or examination: uniform, they shall be combined to (a) Two ounces (57 grams) of grass form a composite sample. seed not otherwise mentioned, white or alsike clover, or seeds not larger than [5 FR 32, Jan. 4, 1940, as amended at 10 FR 9950, Aug. 11, 1945; 25 FR 8769, Sept. 13, 1960; these. 26 FR 10035, Oct. 26, 1961] (b) Five ounces (142 grams) of red or crimson clover, alfalfa, lespedeza, rye- § 201.40 Bulk. grass, bromegrass, millet, flax, rape, or Bulk seeds or screenings shall be seeds of similar size. sampled by inserting a long probe or (c) One pound (454 grams) of thrusting the hand into the bulk as cir- sudangrass, proso millet, hemp, or cumstances require in at least seven seeds of similar size. uniformly distributed parts of the (d) Two pounds (907 grams) of cereals, quantity being sampled. At least as sorghum, vetch, or seeds of similar or many trierfuls or handfuls shall be larger size. taken as the minimum which would be (e) Two quarts (2.2 liters) of required for the same quantity of seed screenings. or screenings in bags of a size custom- (f) Vegetable seed samples shall con- arily used for such seed or screenings. sist of at least 400 seeds. (g) Coated seed for a purity analysis [5 FR 32, Jan. 4, 1940, as amended at 26 FR shall consist of at least 7,500 seed units. 10035, Oct. 26, 1961] Coated seed for noxious-weed seed ex- § 201.41 Bags. amination shall consist of at least 30,000 seed units. Coated seed for germi- (a) For lots of six bags or less, each nation test only shall consist of at bag shall be sampled. A total of at least 1,000 seed units. least five trierfuls shall be taken. (b) For lots of more than six bags, [10 FR 9950, Aug. 11, 1945, as amended at 15 five bags plus at least 10 percent of the FR 2394, Apr. 28, 1950; 59 FR 64492, Dec. 14, number of bags in the lot shall be sam- 1994] pled. (Round off numbers with decimals § 201.44 Forwarding samples. to the nearest whole number, raising 0.5 to the next whole number.) Regard- Before being forwarded for analysis, less of the lot size it is not necessary test, or examination, the containers of that more than 30 bags be sampled. samples shall be properly sealed and (c) Samples shall be drawn from un- identified in such manner as may be opened bags except under cir- prescribed by AMS. Samples of coated cumstances where the identity of the seed shall be forwarded in firmly seed has been preserved. packed crush-proof and moisture-proof containers. [5 FR 32, Jan. 4, 1940, as amended at 26 FR 10035, Oct. 26, 1961] [59 FR 64492, Dec. 14, 1994]
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PURITY ANALYSIS IN THE products, (3) total the percentages of ADMINISTRATION OF THE ACT all components of the mixtures, and (4) divide the sum in paragraph (c)(2) of § 201.45 Obtaining the working sam- this section by the total in paragraph ple. (c)(3) of this section. If the approxi- (a) The working sample on which the mate percentage of the components of actual analysis is made shall be taken a mixture are not known they may be from the submitted sample in such a estimated. The weight of the noxious- manner that it will be representative. weed seed working sample shall be de- (b) The sample shall be repeatedly di- termined by multiplying the weight of vided to the weight to be used for the the purity working sample by 10 or by working sample. Some form of efficient calculating the weighted average in the mechanical divider should be used. To same manner described above for the avoid damaging large seeds and coated purity working sample. seeds, a divider should be used which (d) Coated seed. will prevent the seeds from falling (1) Unmixed coated seed. Due to vari- great distances onto hard surfaces. In ation in the weight of coating mate- case the proper mechanical divider rials, the size or weight of the working cannot be used or is not available, the sample shall be determined separately sample shall be thoroughly mixed and for each lot. The weight of the working placed in a pile and the pile shall be re- sample shall be determined by weigh- peatedly divided into halves until a ing 100 completely coated units and sample of the desired weight remains. calculating the weight of 2,500 coated [5 FR 32, Jan. 4, 1940, as amended at 20 FR units for the purity analysis and 25,000 7929, Oct. 21, 1955; 25 FR 8769, Sept. 13, 1960; 59 coated units for the noxious-weed seed FR 64492, Dec. 14, 1994] examination. (2) Mixtures of coated seed. The § 201.46 Weight of working sample. working weight shall be determined in (a) Unmixed seed. The working sam- the following manner: ples for purity analysis and (i) Calculate the weight of the work- noxiousweed seed examination of ing sample to be used for the mixture unmixed seed shall be at least the under consideration as though the sam- weights set forth in table 1. ple were not coated by following para- (b) Mixtures consisting of one predomi- graph (b) or (c) of this section. nant kind of seed or a group of kinds of (ii) Determine the amount of coating similar size. The weights of the purity material on 100 coated units by weigh- and noxious-weed seed working sam- ing the coated units. Remove the coat- ples in this category shall be deter- ing material using the methods de- mined by the kind or group of kinds scribed in §§ 201.51b (c) and (d). Cal- which compromise more than 50 per- culate the percentage of coating mate- cent of the sample. rial using the following formulas: (c) Mixtures consisting of two or more Weight of coating material = weight of kinds or groups of kinds of different sizes, 100 coated units ¥ weight of 100 de- none of which comprise over 50 percent of coated units; the sample. The weights of the purity The percentage of coating material = working samples in this category shall weight of the coating material di- be the weighted averages (to the near- vided by the weight of 100 coated est half gram) of the weights listed in units × 100%. table 1 for each of the kinds which (iii) The weight of the working sam- comprise the sample determined by the ple shall be the product of the weight following method: (1) Multiply the per- calculated in paragraph (d)(2)(i) of this centage of each component in the mix- section multiplied by 100 percent, di- ture (rounded off to the nearest whole vided by 100 percent minus the percent- number) by the sample sizes specified age of coating material calculated in in column 2, table 1, (2) add all these paragraph (d)(2)(ii) of this section.
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TABLE 1—WEIGHT OF WORKING SAMPLE
Minimum Minimum weight for Approximate weight for pu- noxious-weed number of Name of seed rity analysis seed exam- seeds per (grams) ination gram (grams)
Agricultural Seed Agrotricum ...... 65 50039 Alfalfa ...... 5 50 500 Alfilaria ...... 5 50 440 Alyceclover ...... 5 50 665 Bahiagrass: Var. Pensacola ...... 5 50 600 All other vars...... 7 50 365 Barley ...... 100 500 30 Barrelclover ...... 10 100 250 Bean: Adzuki ...... 200 500 11 Field ...... 500 500 4 Mung ...... 100 500 24 Beet, field ...... 50 500 55 Beet, sugar ...... 50 50055 Beggarweed, Florida ...... 5 50 440 Bentgrass: Colonial ...... 0.25 2.5 13,000 Creeping ...... 0.25 2.5 13,515 Velvet ...... 0.25 2.5 18,180 Bermudagrass ...... 1 10 3,930 Bermudagrass, giant ...... 1 10 2,950 Bluegrass: Annual ...... 1 10 2,635 Bulbous ...... 4 40 585 Canada ...... 0.5 5 5,050 Glaucantha ...... 1 10 ...... Kentucky ...... 1 10 3,060 Nevada ...... 1 10 2,305 Rough ...... 0.5 5 4,610 Texas ...... 1 10 2,500 Wood ...... 0.5 5 4,330 Bluejoint ...... 0.5 5 8,461 Bluestem: Big ...... 7 70 320 Little ...... 5 50 525 Sand ...... 10 100 215 Yellow ...... 1 10 1,945 Bottlebrush-squirreltail ...... 9 90 300 Brome: Field ...... 5 50 465 Meadow ...... 13 130 190 Mountain ...... 20 200 140 Smooth ...... 7 70 315 Broomcorn ...... 40 400 60 Buckwheat ...... 50 500 45 Buffalograss: (Burs) ...... 20 200 110 (Caryopses) ...... 3 30 740 Buffelgrass: (Fascicles) ...... 6 66 365 (Caryopses) ...... 2 20 1,940 Burclover, California: (in bur) ...... 50 500 ...... (out of bur) ...... 7 70 375 Burclover, spotted (in bur) ...... 50 500 50 (out of bur) ...... 5 50 550 Burnet, little ...... 25 250 110 Buttonclover ...... 7 70 365 Canarygrass ...... 20 200 150 Canarygrass, reed ...... 2 20 1,185 Carpetgrass ...... 1 10 2,230 Castorbean ...... 500 5005 Chess, soft ...... 5 50 555 Chickpea ...... 500 500 2 Clover:
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TABLE 1—WEIGHT OF WORKING SAMPLE—Continued
Minimum Minimum weight for Approximate weight for pu- noxious-weed number of Name of seed rity analysis seed exam- seeds per (grams) ination gram (grams)
Alsike ...... 2 20 1,500 Arrowleaf ...... 4 40 705 Berseem ...... 5 50 455 Cluster ...... 1 10 2,925 Crimson ...... 10 100 330 Kenya ...... 2 20 Ladino ...... 2 20 1,935 Lappa ...... 2 20 1,500 Large hop ...... 1 10 5,435 Persian ...... 2 20 1,415 Red ...... 5 50 600 Rose ...... 7 70 360 Small hop ...... 2 20 1,950 Strawberry ...... 5 50 635 Sub ...... 25 250 120 White ...... 2 20 1,500 Corn: Field ...... 500 500 3 Pop ...... 500 500 3 Cotton ...... 300 500 8 Cowpea ...... 300 500 8 Crambe ...... 25 250 ...... Crested dogtail ...... 2 20 1,900 Crotalaria: Lance ...... 7 70 375 Showy ...... 25 250 80 Slenderleaf ...... 10 100 205 Striped ...... 10 100 215 Sunn ...... 75 500 35 Crownvetch ...... 10 100 305 Dallisgrass ...... 4 40 620 Dichondra ...... 5 50 470 Dropseed, sand ...... 0.25 2.5 12,345 Emmer ...... 100 500 25 Fescue: Chewings ...... 3 30 900 Hair ...... 1 10 ...... Hard ...... 2 20 1,305 Meadow ...... 5 50 495 Red ...... 3 30 900 Sheep ...... 2 20 1,165 Tall ...... 5 50 455 Flatpea ...... 100 500 25 Flax ...... 15 150 180 Foxtail, creeping ...... 1.5 15 1,736 Foxtail, meadow ...... 3 30 893 Galletagrass: (Other than caryopses) ...... 10 100 260 (Caryopses) ...... 5 50 580 Grama: Blue ...... 2 20 1,595 Side-oats: (Other than caryopses) ...... 6 60 350 (Caryopses) ...... 2 20 1,605 Guar ...... 75 500 35 Guineagrass ...... 2 20 2,205 Hardinggrass ...... 3 30 750 Hemp ...... 50 500 45 Indiangrass, yellow ...... 7 70 395 Indigo, hairy ...... 7 70 435 Japanese lawngrass ...... 2 20 1,325 Johnsongrass ...... 10 100 265 Kenaf ...... 50 500 ...... Kochia, forage ...... 2 20 1,070 Kudzu ...... 25 250 80 Lentil ...... 120 500 14Ð23 Lespedeza: Korean ...... 5 50 525
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TABLE 1—WEIGHT OF WORKING SAMPLE—Continued
Minimum Minimum weight for Approximate weight for pu- noxious-weed number of Name of seed rity analysis seed exam- seeds per (grams) ination gram (grams)
Sericea ...... 3 30 820 Siberian ...... 3 30 820 Striate ...... 5 50 750 Lovegrass, sand ...... 1 10 3,585 Lovegrass, weeping ...... 1 10 3,270 Lupine: Blue ...... 500 500 7 White ...... 500 500 7 Yellow ...... 300 500 9 Manilagrass ...... 2 20 ...... Medic, black ...... 5 50 585 Milkvetch ...... 9 90 270 Millet: Browntop ...... 8 80 315 Foxtail ...... 5 50 480 Japanese ...... 9 90 315 Pearl ...... 15 150 180 Proso ...... 15 150 185 Molassesgrass ...... 0.5 5 7,750 Mustard: Black ...... 2 20 1,255 India ...... 5 50 625 White ...... 15 150 160 Napiergrass ...... 5 50 ...... Needlegrass, green ...... 7 70 370 Oat ...... 75 500 35Ð50 Oatgrass, tall ...... 6 60 417 Orchardgrass ...... 3 30 945 Panicgrass, blue ...... 2 20 1,370 Panicgrass, green ...... 2 20 1,305 Pea, field ...... 500 500 4 Peanut ...... 500 500 1Ð3 Rape: Annual ...... 7 70 345 Bird ...... 7 70 425 Turnip ...... 5 50 535 Winter ...... 10 100 230 Redtop ...... 0.25 2.5 10,695 Rescuegrass ...... 20 200 115 Rhodesgrass ...... 1 10 4,725 Rice ...... 50 500 65 Ricegrass, Indian ...... 7 70 355 Roughpea ...... 75 500 40 Rye ...... 75 500 40 Rye, mountain ...... 28 280 90 Ryegrass: Annual ...... 5 50 420 Intermediate ...... 8 80 338 Perennial ...... 5 50 530 Wimmera ...... 5 50 ...... Safflower ...... 100 500 30 Sagewort, Louisiana ...... 0.5 5 8,900 Sainfoin ...... 50 500 50 Saltbush, fourwing ...... 15 150 165 Sesame ...... 7 70 360 Sesbania ...... 25 250 105 Smilo ...... 2 20 2,010 Sorghum ...... 50 50055 Sorghum almum ...... 15 150 150 Sorghum-sudangrass ...... 65 500 38 Sorgrass 1 ...... 15 150 135 Sourclover ...... 5 50 660 Soybean ...... 500 500 6Ð13 Spelt ...... 100 500 25 Sudangrass ...... 25 250 100 Sunflower ...... 100 500 ...... Sweetclover: White ...... 5 50 570
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TABLE 1—WEIGHT OF WORKING SAMPLE—Continued
Minimum Minimum weight for Approximate weight for pu- noxious-weed number of Name of seed rity analysis seed exam- seeds per (grams) ination gram (grams)
Yellow ...... 5 50 570 Sweet vernalgrass ...... 2 20 1,600 Sweetvetch, northern ...... 19 190 130 Switchgrass ...... 4 40 570 Timothy ...... 1 10 2,565 Timothy, turf ...... 1 10 2,565 Tobacco ...... 0.5 5 15,625 Trefoil: Big ...... 2 20 1,945 Birdsfoot ...... 3 30 815 Triticale ...... 100 500 ...... Vaseygrass ...... 3 30 970 Veldtgrass ...... 4 40 655 Velvetbean ...... 500 500 2 Velvetgrass ...... 1 10 3,360 Vetch: Common ...... 150 500 19 Hairy ...... 75 500 35 Hungarian ...... 100 500 24 Monantha ...... 100 500 ...... Narrowleaf ...... 50 500 60 Purple ...... 100 500 22 Woollypod ...... 100 500 25 Wheat: Common ...... 100 500 25 Club ...... 100 500 25 Durum ...... 100 500 25 Polish ...... 100 500 25 Poulard ...... 100 500 25 Wheat x Agrotricum ...... 65 500 38 Wheatgrass: Beardless ...... 8 80 275 Fairway crested ...... 4 40 685 Standard crested ...... 5 50 425 Intermediate ...... 15 150 175 Pubescent ...... 15 150 180 Siberian ...... 5 50 ...... Slender ...... 7 70 295 Streambank ...... 10 50 370 Tall ...... 15 150 165 Western ...... 10 100 250 Wildrye: Basin ...... 8 80 317 Canada ...... 11 110 190 Russian ...... 6 60 360 Vegetable Seed Artichoke ...... 100 500 24 Asparagus ...... 100 50025 Asparagusbean ...... 300 500 8 Bean: Garden ...... 500 500 4 Lima ...... 500 500 2 Runner ...... 500 500 1 Beet ...... 50 300 60 Broadbean ...... 500 500 ...... Broccoli ...... 10 50 315 Brussels sprouts ...... 10 50 315 Burdock, great ...... 15 150 ...... Cabbage ...... 10 50 315 Cabbage, Chinese ...... 5 50 635 Cabbage, tronchuda ...... 10 100 ...... Cardoon ...... 100 500 ...... Carrot ...... 3 50 825 Cauliflower ...... 10 50 315 Celeriac ...... 1 25 2,520 Celery ...... 1 25 2,520 Chard, Swiss ...... 50 300 60 Chicory ...... 3 50 940
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TABLE 1—WEIGHT OF WORKING SAMPLE—Continued
Minimum Minimum weight for Approximate weight for pu- noxious-weed number of Name of seed rity analysis seed exam- seeds per (grams) ination gram (grams)
Chives ...... 5 50 ...... Citron ...... 200 500 11 Collards ...... 10 50 315 Corn, sweet ...... 500 500 ...... Cornsalad: Vars. Fullhearted and Dark Green Fullhearted ...... 5 50 ...... All other vars ...... 10 50 380 Cowpea ...... 300 500 8 Cress: Garden ...... 5 50 425 Upland ...... 2 35 1,160 Water ...... 1 25 5,170 Cucumber ...... 75 500 40 Dandelion ...... 2 35 1,240 Dill ...... 3 50 800 Eggplant ...... 10 50 230 Endive ...... 3 50 940 Gherkin, West India ...... 16 160 153 Kale ...... 10 50 315 Kale, Chinese ...... 10 50 ...... Kale, Siberian ...... 8 80 325 Kohlrabi ...... 10 50 315 Leek ...... 7 50 395 Lettuce ...... 3 50 890 Melon ...... 50 500 45 Mustard, India ...... 5 50 625 Mustard, spinach ...... 5 50 535 Okra ...... 100 500 19 Onion ...... 7 50 340 Onion, Welsh ...... 10 50 ...... Pak-choi ...... 5 50 635 Parsley ...... 5 50 650 Parsnip ...... 5 50 430 Pea ...... 500 500 3 Pepper ...... 15 150 165 Pumpkin ...... 500 500 5 Radish ...... 30 300 75 Rhubarb ...... 50 300 60 Rutabaga ...... 5 50 430 Sage ...... 25 150 120 Salsify ...... 50 300 65 Savory, summer ...... 2 35 1,750 Sorrel ...... 2 35 1,080 Soybean ...... 500 500 6Ð13 Spinach ...... 25 150 100 Spinach, New Zealand ...... 200 500 13 Squash ...... 200 500 14 Tomato ...... 5 50 405 Tomato, husk ...... 2 35 1,240 Turnip ...... 5 50 535 Watermelon ...... 200 500 11 1 Rhizomatous derivatives of a johnsongrass x sorghum cross or a johnsongrass x sudangrass cross.
[25 FR 8769, Sept. 13, 1960, and 30 FR 7888, figures and shall then be separated into June 18, 1965, as amended at 32 FR 12780, four parts: (1) Kind or variety to be Sept. 6, 1967; 35 FR 6108, Apr. 15, 1970; 41 FR considered pure seed, (2) other crop 20156, May 17, 1976; 46 FR 53635, Oct. 29, 1981; 59 FR 64492, Dec. 14, 1994; 65 FR 1707, Jan. 11, seed, (3) weed seed, and (4) inert mat- 2000] ter. The components shall be weighed in grams to the same number of dec- § 201.47 Separation. imal places as the working sample. The (a) The working sample shall be percentage of each part shall be deter- weighed in grams to four significant mined to two decimal places.
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(b) Aids for the classification of pure an equivalent weight shall be taken in- seed, other crop seed, weed seed, and discriminately from the pure seed com- inert matter may include visual exam- ponent and the separation made on this ination, use of transmitted light portion. The proportion of each kind (diaphanoscope), or specific gravity present shall then be determined by (seed blowers). Specific instructions for weight and from this the percentage in classification of the various compo- the entire sample shall be calculated. nents are given in §§ 201.47a to 201.51, (e) The Uniform Blowing Procedure inclusive. described in § 201.51a(a) shall be used (c) The components shall be weighed for the separation of pure seed and and percentages calculated as follows: inert matter in seeds of Kentucky blue- (1) For sample sizes less than 25 grass, Canada bluegrass, rough blue- grams, all four components shall be grass, Pensacola variety of bahiagrass, weighed; the percentages shall be based orchardgrass, side-oats grama, and blue on the sum of these weights and not on grama. the original weight. The sum of these (f) Procedures for purity analysis for weights shall be compared with the coated seed are given in § 201.51b. original weight of the working sample as a check against the loss of material, [25 FR 8770, Sept. 13, 1960, as amended at 30 or other errors. FR 7890, June 18, 1965; 46 FR 53635, Oct. 29, 1981; 59 FR 64497, Dec. 14, 1994; 65 FR 1707, (2) For sample sizes of 25 grams or Jan. 11, 2000] more, the components—other crop seed, weed seed, and inert matter— § 201.47a Seed unit. shall be weighed separately and their percentages determined by dividing The seed unit is the structure usually these weights by the original weight of regarded as a seed in planting practices the working sample. The pure seed and in commercial channels. The seed need not be weighed; its percentage unit may consist of one or more of the may be determined by subtracting the following structures: sum of the percentages of the other (a) True seeds; three components from 100. (b) For the grass family: (3) When rounding off the calculated (1) Caryopses and single florets; percentages of each component to the (2) Multiple florets and spikelets in second decimal place, round down if tall oatgrass (Arrhenatherum elatius), the third decimal place is 4 or less and oat (Avena spp.), gramas (Bouteloua round up if the third decimal place is 5 spp.), rhodesgrass (Chloris gayana), or more, except that if any component barley (Hordeum vulgare), and blue- is determined to be present in any grass (Poa spp.); amount calculated to be less than 0.015 (3) Entire spikelets in bahiagrass, percent, then that component shall be bentgrasses, dallisgrass, guineagrass, reported as 0.01 percent. If any compo- browntop millet, foxtail millet, proso nent is not found in the purity anal- millet, panicgrasses, redtop, rice, ysis, then that component shall be re- switchgrass, and vaseygrass. Entire ported as 0.00 percent. spikelets which may have attached ra- (4) The total percentage of all compo- chis segments, pedicels, and sterile nents shall be 100.00 percent. If the spikelets in big bluestem, little total does not equal 100.00 percent (e.g. bluestem, sand bluestem, yellow 99.99 percent or 100.01 percent), then bluestem, bottlebrush-squirreltail, add to or subtract from the component broomcorn, yellow indiangrass, with the largest value (usually the johnsongrass, sorghum, sorghum- pure seed component). sudangrass, sorghum almum, sorgrass, (d) When the working sample consists and sudangrass; of two or more similar kinds or vari- (4) Spikelet groups: eties which would be difficult to sepa- (i) Spikelet groups that disarticulate rate in the entire sample, it is permis- as a unit in galletagrass; sible to weigh the similar kinds or va- (ii) Spikelet groups that rieties together as one component and disarticulate as units with attached ra- make the separation on a reduced por- chis and internodes in bluestems, side- tion of the sample. At least 400 seeds or oats grama, and yellow indiangrass;
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(5) Fascicles of buffelgrass (Cenchrus shown on the label as components of a ciliaris) consisting of bristles and mixture in amounts of 5 percent or spikelets; less. The following shall be included (6) Burs of buffalograss (Buchloe with the pure seed: dactyloides); (a) Immature or shriveled seeds and (7) Bulblets of bulbous bluegrass (Poa seeds that are cracked or injured. For bulbosa); seeds of legumes (Leguminosae) and (8) Multiple units as defined in crucifers (Cruciferae) with the seed § 201.51a(b)(1). coats entirely removed refer to (c) Dry indehiscent fruits in the fol- § 201.51(a)(1); lowing plant families: Buckwheat (b) Pieces of seeds which are larger (Polygonaceae), sunflower than one-half of the original size. For (Compositae), geranium (Geraniaceae), separated cotyledons of legume seeds goosefoot (Chenopodiaceae), and vale- refer to § 201.51(a)(2); rian (Valerianaceae); (c) Insect-damaged seeds, provided (d) One- and two-seeded pods of that the damage is entirely internal, or small-seeded legumes (Leguminosae), that the opening in the seed coat is not burs of the burclovers (Medicago sufficiently large so as to allow the size arabica, M. polymorpha), and pods of of the remaining mass of tissue to be peanuts (Arachis hypogaea). (This does readily determined. Weevil-infested not preclude the shelling of small-seed- vetch seeds, irrespective of the amount ed legumes for purposes of identifica- of insect damage, are to be considered tion.) Pods of legumes normally con- pure seed, unless they are broken taining more than two seeds, when oc- pieces one-half or less than the original curring incidentally in the working size. For classification of broken pieces sample, should be hulled if the kind is of seed units one-half or less than the hulled when marketed; original size, refer to § 201.51(a)(2). (e) Fruits or half fruits in the carrot Refer to § 201.51(a)(3) for chalcid-dam- family (Umbelliferae); aged seeds; (f) Nutlets in the following plant (d) Seeds that have started to ger- families: Borage (Boraginaceae), mint minate; (Labiatae), and vervain (Verbenaceae); (e) Seeds of the cucurbit family (g) ‘‘Seed balls’’ or portions thereof (Cucurbitaceae) and the nightshade in multigerm beets, and fruits with ac- family (Solanaceae) whether they are cessory structures such as occur in filled or empty; other Chenopodiaceae and New Zealand (f) Intact fruits, whether or not they spinach. For forage kochia refer to contain seed, of species belonging to § 201.48(j) and § 201.51(a)(7). the following families: Sunflower [46 FR 53636, Oct. 29, 1981, as amended at 59 (Compositae), buckwheat FR 64497, Dec. 14, 1994; 65 FR 1707, Jan. 11, (Polygonaceae), carrot (Umbelliferae), 2000] valerian (Valerianaceae), mint (Labiatae) and other families in which § 201.47b Working samples. the seed unit may be a dry, indehiscent The purity working sample is the one-seeded fruit. For visibly empty sample on which the purity analysis is fruits, refer to inert matter, made. The noxious-weed seed working § 201.51(a)(6); sample is the sample on which the nox- (g) Seed units of the grass family ious-weed seed examination is made. listed in § 201.47a(b) (1) through (5) if a [20 FR 7930, Oct. 21, 1955] caryopsis with some degree of endosperm development can be de- § 201.48 Kind or variety considered tected in the units, either by slight pure seed. pressure or by examination over light. The pure seed shall include all seeds Species in which determination of of each kind or each kind and variety endosperm development is not nec- under consideration present in excess essary are listed in paragraphs (g) (1) of 5 percent of the whole. Seeds of and (2) of this section. Refer to kinds or kinds and varieties present to §§ 201.48(h) and 201.51(a)(5) when nema- the extent of 5 percent or less of the tode galls and fungal bodies have re- whole may be considered pure seed if placed the caryopsis in seed units. The
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following procedures apply to deter- which may be applied as acceptable al- mine pure seed in the grass families ternatives: listed below: (1) Uniform Blowing Procedure in (1) Intact burs of buffalograss § 201.51a(a) for kinds listed in § 201.47(e) (Buchloe dactyloides) shall be consid- may be disregarded. If disregarded, all ered pure seed whether or not a cary- seed units (as defined in § 201.47a) for opsis is present. Refer to § 201.51(a)(6) these kinds found in the working sam- for burs which are visibly empty. ple shall be manually separated into (2) The Uniform Blowing Procedure pure seed and inert matter. Only units described in § 201.51a(a) shall be used to containing at least one caryopsis with determine classification of florets into some degree of endosperm development pure seed or inert matter for Kentucky which can be detected either by slight bluegrass, Canada bluegrass, rough pressure or by examination over light bluegrass, Pensacola variety of are considered other crop seed. bahiagrass, side-oats grama, blue (2) Multiple Unit Procedure in grama, and orchardgrass. § 201.51a(b) for kinds listed in (3) Special purity procedures for § 201.48(g)(3) may be disregarded. If dis- smooth brome, chewings fescue, red regarded, all multiple units and single fescue, orchardgrass, fairway crested units (as defined in § 201.51a(b)) for wheatgrass, standard crested these kinds found in the working sam- wheatgrass, intermediate wheatgrass, ple shall be manually separated into pubescent wheatgrass, tall wheatgrass, single florets. Each floret containing a and western wheatgrass are listed in caryopsis with some degree of § 201.51a(b). endosperm development, which can be (4) For methods of determining pure detected either by slight pressure or seed percentages of annual and peren- examination over light, is considered nial ryegrass, refer to §§ 201.58(b)(10) other crop seed. Empty florets and and 201.58a(a). glumes, if present, are considered inert (h) Seed units with nematode galls, matter. Refer to § 201.51(a)(4). fungal bodies (i.e. ergot, other sclerotia, and smut) and spongy or (b) [Reserved] corky caryopses that are entirely en- [59 FR 64498, Dec. 14, 1994; 60 FR 2493, Jan. 10, closed within the seed unit. Refer to 1995] § 201.51(c)(1) for inert matter classifica- tion. § 201.50 Weed seed. (i) Seed units of beet and other Seeds (including bulblets or tubers) Chenopodiaceae, and New Zealand spin- of plants shall be considered weed seeds ach. Refer to § 201.47a(g) and when recognized as weed seeds by the § 201.51(a)(6) for definitions of seed units law or rules and regulations of the and inert matter, respectively. State into which the seed is offered for (j) Seed units of forage kochia that transportation or transported; or by are retained on a 1 mm opening square- the law or rules and regulations of hole sieve, when shaken for 30 seconds. Puerto Rico, Guam, or District of Co- For inert matter, refer to § 201.51(a)(7). lumbia into which transported, or Dis- [46 FR 53636, Oct. 29, 1981, as amended at 59 trict of Columbia in which sold; or FR 64497, Dec. 14, 1994] found by the Secretary of Agriculture to be detrimental to the agricultural § 201.49 Other crop seed. interests of the United States, or any (a) Seeds of plants grown as crops part thereof. Damaged weed seeds and (other than the kind(s) and variety(ies) immature seedlike structures, as de- included in the pure seed) shall be con- scribed in § 201.51(b), shall be considered sidered other crop seeds, unless recog- inert matter. Weed seeds, as defined nized as weed seeds by applicable laws, above in this section, requiring further or regulations, or by general usage. All separation into weed seed and inert interpretations and definitions for matter components are as follows: ‘‘pure seed’’ in § 201.48 shall also apply (a) The individual seeds are to be re- in determining whether seeds are moved from fruiting structures such as ‘‘other crop seed’’ or ‘‘inert matter’’ pods and heads. The seeds are classified with the following two exceptions as weed seed and the remaining
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fruiting structures classified as inert indehiscent one-seeded fruit that visi- matter. bly do not contain a seed. Refer to (b) Wild onion and wild garlic (Allium § 201.48 (f), (g)(1), (i), and (j) for pure spp.) bulblets that have any part of the seed classification. husk remaining and are not damaged (7) Seed units of forage kochia that at the basal end are considered weed pass through a 1 mm opening, square- seeds regardless of size. Bulblets that hole sieve, when shaken for 30 seconds. are completely devoid of husk, and are (8) The thin pericarp (fruit wall), if not damaged at the basal end, and are present on seeds of northern retained by a 1⁄13-inch (1.9 mm) round- sweetvetch. hole sieve are considered weed seeds. (b) Seeds and seed-like structures For wild onion and wild garlic (Allium from weed plants, which by visual ex- spp.) bulblets classed as inert matter, amination (including the use of light or refer to § 201.51(b)(5). dissection), can be determined to be [46 FR 53636, Oct. 29, 1981, as amended at 59 within the following categories: FR 64498, Dec. 14, 1994; 65 FR 1707, Jan. 11, (1) Damaged seed (other than grasses) 2000] with over one-half of the embryo miss- ing. § 201.51 Inert matter. (2) Grass florets and caryopses Inert matter shall include seeds and classed as inert: seed-like structures from both crop and (i) Glumes and empty florets of weed plants and other material not weedy grasses; seeds as follows: (ii) Damaged grass caryopses, includ- (a) Seeds and seed-like structures ing free caryopses, with over one-half from crop plants: the root-shoot axis missing (the (1) Seeds of legumes (Leguminosae) scutellum excluded); and crucifers (Cruciferae) with the seed (iii) Immature free caryopses devoid coats entirely removed. Refer to of embryo and/or endosperm; § 210.48(a) for pure seed classification. (iv) Immature florets of quackgrass (2) Pieces of broken and damaged (Agropyron repens) in which the seed units, including those that are in- caryopses are less than one-third the sect damaged, which are one-half the length of the palea. The caryopsis is original size or less. If greater than measured from the base of the rachilla; one-half, refer to § 201.48(b) and (c) for (v) Free caryopses of quackgrass (A. pure seed classification. Also included repens) that are 2 mm or less in length. as inert matter are separated (3) Seeds of legumes and species of cotyledons of legumes, irrespective of Brassica with the seed coats entirely whether or not the radicle-plumule removed. axis and/or more than one-half of the (4) Immature seed units, devoid of seed coat may be attached. both embryo and endosperm, such as (3) Chalcid-damaged seeds (puffy, occur in but not limited to the fol- soft, or dry and crumbly) of alfalfa, red lowing plant families: Sedge clover, crimson clover, and similar (Cyperaceae), buckwheat kinds of small seeded legumes. Refer to (Polygonaceae), morning glory § 201.48(c) for pure seed classification. (Convolvulaceae), nightshade (4) Glumes and empty florets except (Solanaceae), puncturevine as stated under pure seed. Refer to (Zygophyllaceae) and sunflower § 201.48 (g) and (h) for pure seed classi- (Compositae). Cocklebur (Xanthium fication. (5) Seed units with nematode galls or spp.) burs are to be dissected to deter- fungal bodies (smut, ergot, and other mine whether or not seeds are present. sclerotia) that are not entirely en- (5) Wild onion and wild garlic (Allium closed within the seed unit. Refer to spp.) bulblets: § 201.48(h) for pure seed classification. (i) Bulblets which are completely de- (6) Broken seed units of void of the husk and pass through a Chenopodiaceae and fruit portions or 1/13th-inch, round-hole sieve. fragments of monogerm beets, New (ii) Bulblets which show evident dam- Zealand spinach, buffalograss, and fam- age to the basal end, whether husk is ilies in which the seed unit is a dry present or absent. Refer to § 201.50(c)
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for wild onion and wild garlic (Allium (i) The blowing point for Canada spp.) bulblets classed as weed seeds. bluegrass shall be the same as the (6) Dodder (Cuscuta spp.): Seeds de- blowing point determined for Kentucky void of embryos and seeds which are bluegrass. ashy gray to creamy white in color are (ii) The blowing point for rough blue- inert matter. Seeds should be sectioned grass shall be a factor of 0.82 (82 per- when necessary to determine if an em- cent) of the blowing point determined bryo is present as when seeds have a for Kentucky bluegrass. The 0.82 factor normal color but are slightly swollen, is restricted to the General-type seed dimpled or have minute holes. blower. (7) Buckhorn (Plantago lanceolata): (iii) The blowing point for blue Black seeds, with no brown color evi- grama shall be a factor of 1.157 of the dent, whether shriveled or plump; the blowing point determined for Kentucky color of questionable seeds shall be de- bluegrass. Before blowing, extraneous termined by use of a stereoscopic mi- material that will interfere with the croscope with magnification of ap- blowing process shall be removed. The proximately 10× and a fluorescent lamp sample to be blown shall be divided with two 15-watt daylight-type tubes. into four approximately equal parts (8) Ragweed (Ambrosia spp.): Seed and each blown separately. The 1.157 with both the involucre and pericarp factor is restricted to the General-type absent. seed blower. (c) Other matter that is not seed: (iv) The blowing point for side-oats (1) Free nematode galls or fungal grama shall be a factor of 1.480 of the bodies such as smut, ergot, and other blowing point determined for Kentucky sclerotia. bluegrass. Before blowing, extraneous (2) Soil particles, sand, stone, chaff, material that will interfere with the stems, leaves, flowers, loose coating blowing process shall be removed. The material, and any other foreign mate- sample to be blown shall be divided rial. into four approximately equal parts (3) Coating material removed from and each part blown separately. The coated seed by washing. Refer to 1.480 factor is restricted to the General- § 201.51b(c). type seed blower. [46 FR 53637, Oct. 29, 1981; 46 FR 58059, Nov. (3) Calibration samples and instruc- 30, 1981; 59 FR 64498, Dec. 14, 1994; 65 FR 1707, tions are available on loan through the Jan. 11, 2000] Seed Regulatory and Testing Branch, LS, AMS, Building 306, Room 213, § 201.51a Special procedures for purity Beltsville, Maryland 20705. analysis. (4) The calibration samples shall be (a) The Uniform Blowing Procedure used to establish a blowing point prior shall be used for the separation of pure to proceeding with the separation of seed and inert matter in the following: pure seed and inert matter for these Kentucky bluegrass, Canada bluegrass, kinds. After completing the blowing rough bluegrass, Pensacola variety of procedure, remove all weed and other bahiagrass, orchardgrass, blue grama, crop seeds from the light portion and and side-oats grama. add these to the weed or other crop (1) When kinds listed in this section separation, as appropriate. The remain- appear in mixtures they shall be sepa- der of the light portion shall be consid- rated from other kinds before using the ered inert matter. Remove all weed and Uniform Blowing Procedure. other crop seeds and other inert matter (2) To determine the blowing point (stems, leaves, dirt) from the heavy for these procedures, individual cali- portion and add these to the weed seed, bration samples for Kentucky blue- other crop seed, or inert matter separa- grass, orchardgrass, and Pensacola va- tions, as appropriate. The remainder of riety of bahiagrass shall be used. The the heavy portion shall be considered calibration sample for Kentucky blue- pure seed. grass shall be used for Canada blue- (5) With orchardgrass, after the blow- grass, rough bluegrass, blue grama, and ing, proceed with the multiple unit side-oats grama. procedure.
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(b) The Multiple Unit Procedure of (iii) A fertile floret with two or more determining the pure seed fraction attached sterile and/or fertile florets of shall be used only for the kinds in- any length. cluded in the following table when (2) Procedure for determination of multiple units are present in a sample. multiple units: These methods are applicable to the (i) For the single kind: determine the kinds listed when they occur in mix- percentage of single units present, tures or singly. Any single unit with- based on the total weight of single out attached structures, as described units and multiple units. Apply the ap- below, shall be considered a single unit. Multiple units and single units for the propriate factor, as determined from kinds listed shall remain intact. The the following table, to the weight of attached glumes and fertile or sterile the multiple units and add that portion florets shall not be removed from the of the multiple unit weight to the fertile floret. weight of the single units. The remain- (1) A multiple unit is a seed unit that ing multiple unit weight shall be added includes one or more structures as fol- to the weight of the inert matter. lows (the length of the awn shall be (ii) For mixtures that include one or disregarded when determining the more of the kinds in the following length of a fertile floret or an attached table, determine the percentage of sin- structure): gle units, based on the total weight of (i) An attached sterile or fertile flo- single units and multiple units, for ret that extends to or beyond the tip of each kind. Apply the appropriate factor a fertile floret; as determined from the following table, (ii) A fertile floret with basally at- to the weight of multiple units of each tached glume, glumes, or basally at- kind. tached sterile floret of any length;
TABLE OF FACTORS TO APPLY TO MULTIPLE UNITS a
Or- Crested Pubes- Inter- Tall Western Percent of single units Chewings Red chard- wheat- cent mediate wheat- wheat- Smooth of each kind fescue fescue b wheat- wheat- c c brome grass grass grass grass grass grass
50 or below ...... 91 80 80 70 66 72 ——72 50.01Ð55.00 ...... 91 81 81 72 67 74 ——74 55.01Ð60.00 ...... 91 82 81 73 67 75 ——75 60.01Ð65.00 ...... 91 83 82 74 67 76 ——76 65.01Ð70.00 ...... 91 84 82 75 68 77 — 60 78 70.01Ð75.00 ...... 91 86 82 76 68 78 — 66 79 75.01Ð80.00 ...... 91 87 83 77 69 79 50 67 81 80.01Ð85.00 ...... 91 88 83 78 69 80 55 68 82 85.01Ð90.00 ...... 91 89 83 79 69 81 65 70 83 90.01Ð100.00 ...... 91 90 84 79 70 82 70 74 85 a The factors represent the percentages of the multiple unit weights which are considered pure seed. The remaining percent- age is regarded as inert matter. b Includes both standard crested wheatgrass and fairway crested wheatgrass. c Dashes in table indicate that no factors are available at the levels shown.
[59 FR 64498, Dec. 14, 1994] other solvents such as, but not limited to, dilute sodium hydroxide (NaOH). § 201.51b Purity procedures for coated Use of fine mesh sieves is recommended seed. for this procedure, and stirring or (a) The working sample for coated shaking the coated units may be nec- seed is obtained as described in essary to obtain de-coated seed. § 201.46(d) (1) and (2), and weighed in (d) Spread de-coated seed on blotters grams to four significant figures. or filter paper in a shallow container. (b) Any loose coating material shall Air dry overnight at room tempera- be sieved, weighed, and included with ture. the inert matter component. (e) Separation of component parts: (c) Coating material is removed from (1) Kind or variety considered pure the seed by washing with water or seed.
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(2) Other crop seed. ed by the method described in (3) Inert matter. § 201.51b(c). (4) Weed seed. [59 FR 64499, Dec. 14, 1994] (f) The de-coated seed shall be sepa- rated into four components in accord- GERMINATION TESTS IN THE ance with §§ 201.48 through 201.51. ADMINISTRATION OF THE ACT §§ 201.51a (a) and (b) shall not be fol- lowed. The weight of the coating mate- § 201.53 Source of seeds for germina- rial is determined by subtracting the tion. sum of the weights of the other four (a) When both purity and germina- components from the original weight of tion tests are required, seeds for germi- the working sample. The percentage of nation shall be taken from the separa- coating material shall be included with tion of the kind, variety, or type con- the inert matter percentage. Calculate sidered pure seed and shall be counted percentages of all components based on without discrimination as to size or ap- the original weight of the working pearance. sample (see paragraph (a) of this sec- (b) When only a germination test is tion). required and the pure seed is estimated or determined to be at least 98 percent, [59 FR 64499, Dec. 14, 1994] the pure seed for the germination test may be taken indiscriminately from a § 201.52 Noxious-weed seeds. representative portion of the bulk. (a) The determination of the number (c) When only a germination test is of seeds, bulblets, or tubers of indi- required and the pure seed is found to vidual noxious weeds present per unit be less than 98 percent, the seed for the weight should be made on at least the test shall be obtained by separating the minimum quantities listed in § 201.46 sample into two components as follows: Table 1: Provided, That if the following (1) Pure seed and (2) other crop seed, indicated numbers of a single kind of weed seed, and inert matter. In making seed, bulblet, or tuber are found in the this separation at least 1⁄4 of the quan- pure seed analysis (or noxious-weed tity required for a regular purity anal- seed examination of a like amount) the ysis shall be used. The whole sample occurrence of that kind in the remain- must be well mixed and divided in such der of the bulk examined for noxious- a manner as to get a completely rep- weed seeds need not be noted: 1⁄2-gram resentative subsample. purity working sample, 16 or more seeds; 1-gram purity working sample, [10 FR 9952, Aug. 11, 1945, as amended at 20 23 or more seeds; 2-gram purity work- FR 7931, Oct. 21, 1955] ing sample or larger, 30 or more seeds. § 201.54 Number of seeds for germina- The seeds per unit weight shall be tion. based on the number of single seeds. At least 400 seeds shall be tested for The number of individual seeds shall be germination; except that in mixtures, determined in burs of sandbur 200 seeds of each of those kinds present (Cenchrus spp.) and cocklebur to the extent of 15 percent or less may (Xanthium spp.); in capsules of dodder be used in lieu of 400, in which case an (Cuscuta spp.); in berries of additional 2 percent is to be added to groundcherry, horsenettle, and the regular germination tolerances. nightshade (Solanaceae); and in the The seeds shall be tested in replicate fruits of other noxious weeds that con- tests of 100 seeds or less. tain more than one seed. Refer to §§ 201.50 and 201.51(b)(4) for the classi- [59 FR 64500, Dec. 14, 1994] fication of weed seeds and inert matter, respectively. § 201.55 Retests. (b) A noxious-weed seed examination Retests shall be made as follows: of coated seed samples shall be made (a) When the range of 100-seed rep- by examining approximately 25,000 licates of a given test exceeds the max- units obtained in accordance with imum tolerated range in the table ap- § 201.46(d) and which have been de-coat- pearing in this section.
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TABLE OF MAXIMUM TOLERATED RANGES BETWEEN 100-SEED REPLICATES FOR USE IN CONNECTION WITH ¤ 201.55(A)
Average percent germinations Maximum allowed between replicates 4 2 replicates replicates
99 ...... 2 5 98 ...... 3 6 97 ...... 4 7 6 96 ...... 5 8 6 95 ...... 6 9 7 94 ...... 7 10 8 93 ...... 8 10 8 92 ...... 9 11 9 91 ...... 10 11 9 90 ...... 11 12 9 89 ...... 12 12 10 88 ...... 13 13 10 87 ...... 14 13 11 86 ...... 15 14 11 85 ...... 16 14 11 84 ...... 17 14 11 83 ...... 18 15 12 82 ...... 19 15 12 81 ...... 20 15 12 80 ...... 21 16 13 79 ...... 22 16 13 78 ...... 23 16 13 77 ...... 24 17 13 76 ...... 25 17 13 75 ...... 26 17 14 74 ...... 27 17 14 73 ...... 28 17 14 72 ...... 29 18 14 71 ...... 30 18 14 70 ...... 31 18 14 69 ...... 32 18 14 68 ...... 33 18 15 67 ...... 34 18 15 66 ...... 35 19 15 65 ...... 36 19 15 64 ...... 37 19 15 63 ...... 38 19 15 62 ...... 38 19 15 61 ...... 40 19 15 60 ...... 41 19 15 59 ...... 42 19 15 58 ...... 43 19 15 57 ...... 44 19 15 56 ...... 45 19 15 55 ...... 46 20 15 54 ...... 47 20 16 53 ...... 48 20 16 52 ...... 48 20 16 51 ...... 50 20 16
(b) When at the time of the pre- or bacteria, or inaccuracies in counting scribed final count there are indica- or recording results; tions, such as presence of firm (d) When a sample shows seedling in- ungerminated seeds, that a satisfac- jury or abnormality as a result of tory germination has not been ob- chemical treatment, of exposure to tained; chemicals, or of toxicity from any (c) When there is evidence that the source. (Retest shall be made in soil or results may not be reliable due to im- a mixture of soil and sand); proper test conditions, errors in seed- (e) When no two satisfactory tests ling evaluation, the presence of fungi are within tolerance.
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NOTE TO § 201.55: To find the maximum tol- rate of evaporation will depend upon erated range, compute the average percent- the relative humidity of the air, it is age of all 100 seed replicates of a given test, desirable to keep water in the germina- rounding off the result to the nearest whole tion chambers or to provide other number. The germination is found in the first two columns of the table. When the dif- means of supplying a relative humidity ferences between highest and lowest rep- of approximately 95 percent. Germina- licates do not exceed the corresponding val- tion tests should be observed at fre- ues found in the ‘‘4 replicates’’ column, no quent intervals to insure an adequate additional testing is required. However, if moisture supply of the substrata at all the differences exceed the values in the ‘‘4 times. replicates’’ column, retesting is necessary. [20 FR 7931, Oct. 21, 1955] [25 FR 8771, Sept. 13, 1960, as amended at 65 FR 1707, Jan. 11, 2000] § 201.56 Interpretation. (a) A seed shall be considered to have § 201.55a Moisture and aeration of sub- germinated when it has developed stratum. those essential structures which, for (a) The substratum must be moist the kind of seed under consideration, enough to supply the needed moisture are indicative of its ability to produce to the seeds at all times. Excessive a normal plant under favorable condi- moisture which will restrict aeration tions. In general, the following are con- of the seeds should be avoided. Except sidered to be essential structures nec- as provided for those kinds of seeds re- essary for the continued development quiring high moisture levels of the ger- of the seedling (although some struc- mination media, the substrata should tures may not be visible in all kinds at never be so wet that a film of water is the time of seedling evaluation). Seed- formed around the seeds. For most lings possessing these essential struc- kinds of seeds blotters or other paper tures are referred to as normal seed- substrata should not be so wet that by lings: Root system (consisting of pri- pressing, a film of water forms around mary, secondary, seminal, or adven- the finger. titious roots); hypocotyl; epicotyl; cot- (b) The following formula may be yledon(s); terminal bud; primary used as a guide in the preparation of leaves; and coleoptile and mesocotyl sand for germination tests: (in the grass family). Abnormal seed- lings consist of those with defects to [118.3 CC. (1 GILL) SAND/ITS WEIGHT IN these structures, as described in the GRAMS]×20.2¥8.0=THE NUMBER OF CC. abnormal seedling descriptions, and OF WATER TO ADD TO EACH 100 GRAMS are judged to be incapable of continued OF AIR-DRY SAND. growth. The seedling descriptions as- (c) The amount of water provided by sume that test conditions were ade- this formula is satisfactory for seeds quate to allow proper assessment of the the size of clovers and will have to be essential seedling structures. modified slightly, depending on the (b) Sand and/or soil tests may be used kind of seed being tested and the kind as a guide in determining the classi- of sand used. For example, slightly fication of questionable seedlings and more moisture should be added when the evaluation of germination tests the larger seeds are to be tested. made on approved artificial media. (d) In preparing soil tests water This is intended to provide a method of should be added to the soil until it can checking the reliability of tests made be formed into a ball when squeezed in on artificial substrata when there may the palm of the hand but will break be doubt as to the proper evaluation of freely when pressed between two fin- such tests. gers. After the soil has been moistened (c) Seedlings infected with fungi or it should be rubbed through a sieve and bacteria should be regarded as normal put in the seed containers without if all essential structures are present. packing. A seedling that has been seriously (e) The addition of water subsequent damaged by bacteria or fungi from any to placing the seed in test will depend source other than the specific seed on the evaporation from the substrata should be regarded as normal if it is de- in the germination chambers. Since the termined that all essential structures
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were present before the injury or dam- (4) Root system: A primary root; sec- age occurred. Germination counts ondary roots may develop within the should be made on samples where con- test period. tamination and decay are present at (5) Seedling: Frequent counts should approximately 2-day intervals between be made on multigerm beet since the the usual first count and the final growing seedlings will separate from count. During the progress of the ger- the cluster making it difficult to iden- mination test, seeds which are obvi- tify the source. Any cluster which pro- ously dead and moldy and which may duces at least one normal seedling is be a source of contamination of classified as normal; only one normal healthy seeds should be removed at seedling per cluster is to be counted each count and the number of such (see § 201.56(d)). Toxic substances from dead seeds should be recorded. When the clusters of beet and Swiss chard symptoms of certain diseases develop may cause discoloring of the hypocotyl which can be readily recognized and and/or root. Seedlings which are slight- identified, their presence should be ly discolored are to be classified as nor- noted. mal; however, if there is excessive dis- (d) Seed units containing more than coloration, retest by the method in one seed or embryo, such as New Zea- § 201.58(b)(3). land spinach seed, Beta seed, double (b) Abnormal seedling description. fruits of the carrot family (1) Cotyledons: (Umbelliferae), multiple seeds of (i) Less than half of the original cot- burnet, and seed units of grasses con- yledon tissue remaining attached. sisting of multiple florets, shall be (ii) Less than half of the original cot- tested as a single seed and shall be re- yledon tissue free of necrosis or decay. garded as having germinated if they (2) Epicotyl: produce one or more normal seedlings. (i) Missing. (May be assumed to be (e) Standard guides for seedling in- present if cotyledons are intact.) terpretation shall include the following (ii) [Reserved] descriptions for specific kinds and (3) Hypocotyl: groups. The ‘‘General Description’’ for (i) Deep open cracks extending into each group of crop kinds describes a the conducting tissue. seedling without defects. While such a (ii) Malformed, such as markedly seedling is clearly normal, seedlings shortened, curled, or thickened. with some defects may also be classi- (iii) Watery. (4) Root: fied as normal, provided the defects do (i) None. not impair the functioning of the (ii) Weak, stubby, or missing primary structure. The ‘‘Abnormal seedling de- root with weak secondary or adven- scription’’ is to be followed when judg- titious roots. ing the severity of defects. (iii) For discolored roots of beet and [20 FR 7931, Oct. 21, 1955, as amended at 25 FR Swiss chard, see § 201.58(b)(3). 8771, Sept. 13, 1960; 59 FR 64500, Dec. 14, 1994] (5) Seedling: (i) One or more essential structures § 201.56–1 Goosefoot family, impaired as a result of decay from pri- Chenopodiaceae, and Carpetweed mary infection. (For discolored seed- family, Aizoaceae. lings of beet and Swiss chard, see Kinds of seed: Beet, Swiss chard, § 201.58(b)(3).) fourwing saltbush, spinach, New Zea- (ii) Albino. land spinach, and forage kochia. [59 FR 64500, Dec. 14, 1994] (a) General description. (1) Germination habit: Epigeal dicot. § 201.56–2 Sunflower family, (2) Food reserves: Leaf-like Asteraceae (Compositae). cotyledons and perisperm. Kinds of seed: Artichoke, cardoon, (3) Shoot system: The hypocotyl chicory, dandelion, endive, great bur- elongates carrying the cotyledons dock, lettuce, safflower, salsify, Lou- above the soil surface. The epicotyl isiana sagewort, and sunflower. usually does not show any development (a) Lettuce. within the test period. (1) General description.
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(i) Germination habit: Epigeal dicot. flower, salsify, Louisiana sagewort, and (ii) Food reserves: Cotyledons which sunflower. expand and become thin, leaf-like, and (1) General description. photosynthetic. The cotyledons of (i) Germination habit: Epigeal dicot. some varieties develop elongated (ii) Food reserves: Cotyledons which petioles. expand and become thin, leaf-like, and (iii) Shoot system: The hypocotyl photosynthetic. elongates and carries the cotyledons (iii) Shoot system: The hypocotyl above the soil surface. The epicotyl elongates and carries the cotyledons usually does not show any development above the soil surface. The epicotyl within the test period. usually does not show any development (iv) Root system: A long primary within the test period. root. (iv) Root system: A long primary (v) Seedling: The interpretations of root with secondary roots usually de- lettuce seedlings are made only at the veloping within the test period. end of the test period. (2) Abnormal seedling description. (2) Abnormal seedling description. (i) Cotyledons: (A) Less than half of the original cot- (i) Cotyledons: yledon tissue remaining attached. (A) Less than half of the original cot- (B) Less than half of the original cot- yledon tissue remaining attached. yledon tissue free of necrosis or decay. (B) Less than half of the original cot- (Remove any attached seed coats at yledon tissue free of necrosis or decay. the end of the test period for evalua- (Remove attached seed coat for evalua- tion of cotyledons.) tion of cotyledons. Physiological ne- (ii) Epicotyl: crosis is manifested by discolored areas (A) Missing. (May be assumed to be on the cotyledons and should not be present if cotyledons are intact.) confused with natural pigmentation of (B) [Reserved] some lettuce varieties.) (iii) Hypocotyl: (ii) Epicotyl: (A) Deep open cracks extending into (A) Missing. (May be assumed to be the conducting tissue. present if cotyledons are intact.) (B) Malformed, such as markedly (B) Any degree of necrosis or decay. shortened, curled, or thickened. (iii) Hypocotyl: (C) Watery. (A) Deep open cracks extending into (iv) Root: the conducting tissue. (A) None. (B) Severely twisted or grainy. (B) Weak, stubby, or missing primary (C) Watery. root with weak secondary or adven- (iv) Root: titious roots. (Seedlings with roots (A) Stubby or missing primary root. bound within tough seed coats should (Secondary roots will not compensate be left in the test until the final count for a defective primary root.) to allow for development.) (B) Primary root tip blunt, swollen, (v) Seedling: or discolored. (Toxic materials in the (A) One or more essential structures substratum may cause short, blunt impaired as a result of decay from pri- roots; see § 201.58(a)(9).) mary infection. (C) Primary root with splits or le- (B) Albino. sions. [59 FR 64500, Dec. 14, 1994] (v) Seedling: (A) Swollen cotyledons associated § 201.56–3 Mustard family, with extremely short or vestigial Brassicaceae (Cruciferae). hypocotyl and root. Kinds of seed: Broccoli, brussels (B) One or more essential structures sprouts, cabbage, Chinese cabbage, cau- impaired as a result of decay from pri- liflower, collards, garden cress, upland mary infection. cress, water cress, kale, Chinese kale, (C) Albino. Siberian kale, kohlrabi, mustard, (b) Other kinds in the sunflower fam- pakchoi, radish, rape, rutabaga, and ily: Artichoke, cardoon, chicory, dan- turnip. delion, endive, great burdock, saf- (a) General description.
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(1) Germination habit: Epigeal dicot. usually does not show any development (2) Food reserves: Cotyledons which within the test period. expand and become thin, leaf-like and (4) Root system: A long primary root photosynthetic. In Brassica, Sinapis, with numerous secondary roots. and Raphanus, the cotyledons are bi- (b) Abnormal seedling description. lobed and folded, with the outer coty- (1) Cotyledons: ledon being larger than the inner. (i) Less than half of the original cot- (3) Shoot system: The hypocotyl yledon tissue remaining attached. elongates and carries the cotyledons (ii) Less than half of the original cot- above the soil surface; the epicotyl yledon tissue free of necrosis or decay. usually does not show any development (Remove any attached seed coats at within the test period. the end of the test period for evalua- (4) Root system: A long primary root. tion of cotyledons.) (b) Abnormal seedling description. (2) Epicotyl: (1) Cotyledons: (i) Missing. (May be assumed to be (i) Decayed at point of attachment. present if the cotyledons are intact.) (ii) Less than half of the original cot- (ii) [Reserved] yledon tissue remaining attached. (3) Hypocotyl: (iii) Less than half of the original (i) Deep open cracks extending into cotyledon tissue free of necrosis or the conducting tissue. decay. (ii) Malformed, such as markedly (2) Epicotyl: shortened, curled, or thickened. (i) Missing. (May be assumed to be (4) Root: present if the cotyledons are intact.) (i) None. (ii) [Reserved] (ii) Weak, stubby, or missing primary (3) Hypocotyl: root, with less than two strong sec- (i) Deep open cracks extending into ondary or adventitious roots. the conducting tissue. (5) Seedling: (ii) Malformed, such as markedly (i) One or more essential structures shortened, curled, or thickened. impaired as a result of decay from pri- (iii) Watery. mary infection. (4) Root: (ii) Albino. (i) Weak, stubby, or missing primary [59 FR 64501, Dec. 14, 1994] root. (Secondary roots will not com- pensate for a defective root.) § 201.56–5 Grass family, Poaceae (ii) [Reserved] (Gramineae). (5) Seedling: Kinds of seed: Bentgrasses, (i) One or more essential structures bluegrasses, bluestems, bromes, cere- impaired as result of decay from pri- als, fescues, millets, orchardgrass, mary infection. redtop, ryegrasses, sorghums, timothy, (ii) Albino. turf timothy, wheatgrasses, and all [59 FR 64501, Dec. 14, 1994] other grasses listed in § 201.2(h). (a) Cereals: Agrotricum, barley, oat, § 201.56–4 Cucurbit family, rye, mountain rye, wheat, wheat x (Cucurbitaceae). agrotricum, and triticale. Kinds of seed: Citron, cucumber, (1) General description. West India gherkin, melon, pumpkin, (i) Germination habit: Hypogeal squash, and watermelon. monocot. (a) General description. (ii) Food reserves: Endosperm. The (1) Germination habit: Epigeal dicot. scutellum is a modified cotyledon (2) Food reserves: Cotyledons which which is in direct contact with the are large and fleshy; they expand, be- endosperm. During germination the come photosynthetic, and usually per- scutellum remains inside the seed to sist beyond the seedling stage. absorb nutrients from the endosperm (3) Shoot system: The hypocotyl and transfer them to the growing seed- elongates and the cotyledons are pulled ling. free of the seed coat, which often ad- (iii) Shoot system: The shoot consists heres to a peg-like appendage at the of the coleoptile, leaves enclosed in the base of the hypocotyl. The epicotyl coleoptile, and the mesocotyl. The
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coleoptile elongates and pushes mesocotyl may elongate depending on through the soil surface; the mesocotyl the variety and environmental condi- may elongate depending on the variety tions. Splitting of the coleoptile occurs and light intensity, but may not be dis- naturally as a result of growth and cernible. Splitting of the coleoptile oc- emergence of the leaves. curs naturally as a result of growth (iv) Root system: Strong primary and emergence of the leaves. root and seminal roots. Adventitious (iv) Root system: A primary root and roots may start to develop from the seminal roots. The primary root is not mesocotyl or coleoptilar node within readily distinguishable from the sem- the test period. If the mesocotyl elon- inal roots; therefore, all roots arising gates, the adventitious roots will be from the seed are referred to as sem- carried above the grain. inal roots. (2) Abnormal seedling description. (2) Abnormal seedling description. (i) Shoot: (i) Shoot: (A) Missing. (A) Missing. (B) No leaf. (B) No leaf. (C) Leaf extending less than halfway (C) Leaf extending less than halfway up into the coleoptile. up into the coleoptile. (D) Leaf extensively shredded or (D) Leaf extensively shredded or split. split. (E) Spindly or watery. (E) Spindly or watery. (F) Deep open cracks in the (F) Grainy, spirally twisted, shred- mesocotyl. ded, and weak. (ii) Root: (G) Deep open cracks in the (A) None. mesocotyl. (ii) Root: (B) Weak primary root with insuffi- (A) Less than one strong seminal cient seminal or adventitious roots. root. (iii) Seedling: (B) [Reserved] (A) Decayed at point of attachment (iii) Seedling: to the scutellum. (A) Decayed at point of attachment (B) One or more essential structures to the scutellum. impaired as a result of decay from pri- (B) One or more essential structures mary infection. impaired as a result of decay from pri- (C) Albino. mary infection. (c) Corn. (C) Albino. (1) General description. (D) Endosperm obviously detached (i) Germination habit: Hypogeal from the root-shoot axis (e.g. kernel monocot. lifted away by the growing shoot). (ii) Food reserves: Endosperm. The (E) Thickened and shortened roots scutellum is a modified cotyledon and/or shoots. which is in direct contact with the (b) Rice. endosperm. During germination the (1) General description. scutellum remains inside the seed to (i) Germination habit: Hypogeal absorb nutrients from the endosperm monocot. and transfer them to the growing seed- (ii) Food reserves: Endosperm. The ling. scutellum is a modified cotyledon (iii) Shoot system: The shoot consists which is in direct contact with the of the coleoptile, leaves enclosed in the endosperm. During germination the coleoptile, and the mesocotyl. The scutellum remains inside the seed to coleoptile elongates and pushes absorb nutrients from the endosperm through the soil surface. The and transfer them to the growing seed- mesocotyl usually elongates. Splitting ling. of the coleoptile occurs naturally as a (iii) Shoot system: The shoot consists result of growth and emergence of the of the coleoptile, leaves enclosed in the leaves. A twisted and curled shoot coleoptile, and the mesocotyl. The bound by a tough seed coat may be coleoptile elongates and pushes considered normal, provided the shoot through the soil or water surface; the is not decayed.
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(iv) Root system: Strong primary reddish pigmentation may develop on root and seminal roots. Adventitious the root. roots may start to develop from the (2) Abnormal seedling description. mesocotyl or coleoptilar node within (i) Shoot: the test period. (A) Missing. (2) Abnormal seedling description. (B) Thickened and shortened. (i) Shoot: (C) No leaf. (A) Missing. (D) Leaf extending less than halfway (B) Thickened and shortened. up into the coleoptile. (C) No leaf. (E) Leaf extensively shredded or (D) Leaf extending less than halfway split. up into the coleoptile. (F) Spindly or watery. (E) Leaf extensively shredded or (G) Deep open cracks in the split. mesocotyl. (F) Spindly or watery. (ii) Root: (G) Deep open cracks in the (A) None. mesocotyl. (B) Damaged or weak primary root (ii) Root: with less than two strong secondary (A) None. roots. (B) Weak, stubby, or missing primary root with weak seminal roots. (iii) Seedling: (iii) Seedling: (A) Decayed at point of attachment (A) Decayed at point of attachment to the scutellum. to the scutellum. (B) One or more essential structures (B) One or more essential structures impaired as a result of decay from pri- impaired as a result of decay from pri- mary infection. mary infection. (C) Albino. (C) Albino. (e) Grasses and millets. (d) Johnsongrass, sorghum, sorgrass, (1) General description. sorghum almum, sudangrass, and sor- (i) Germination habit: Hypogeal ghum-sudangrass. monocot. (1) General description. (ii) Food reserves: Endosperm. The (i) Germination habit: Hypogeal scutellum is a modified cotyledon monocot. which is in direct contact with the (ii) Food reserves: Endosperm. The endosperm. During germination the scutellum is a modified cotyledon scutellum remains inside the seed to which is in direct contact with absorb nutrients from the endosperm endosperm. During germination the and transfer them to the growing seed- scutellum remains inside the seed to ling. absorb nutrients from the endosperm (iii) Shoot system: The shoot consists and transfer them to the growing seed- of the coleoptile, leaves enclosed in the ling. coleoptile, and the mesocotyl. The (iii) Shoot system: The shoot consists coleoptile elongates and pushes of the coleoptile, leaves enclosed in the through the soil surface. The coleoptile, and the mesocotyl. The mesocotyl may or may not elongate coleoptile elongates and pushes significantly, depending on the kind. through the soil surface; the mesocotyl Splitting of the coleoptile occurs natu- usually elongates. Areas of natural, rally as a result of growth and emer- reddish pigmentation may develop on gence of the leaves. the mesocotyl and coleoptile. Splitting (iv) Root system: A long primary of the coleoptile occurs naturally as a root. Secondary or adventitious roots result of growth and emergence of the may develop within the test period. In leaves. certain kinds (e.g. bermudagrass) the (iv) Root system: A long primary primary root may not be readily visible root, usually with secondary roots de- because it is coiled inside the tightly veloping within the test period. Adven- fitting lemma and palea. At the time of titious roots may start to develop from evaluation, the glumes should be re- the mesocotyl or coleoptilar node with- moved and the root observed. Such in the test period. Areas of natural, seedlings are classified as normal if the
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primary root has developed. For Ken- emerge from between the cotyledons; tucky bluegrass, a primary root 1⁄16 the primary leaves expand rapidly. inch (1.6 mm) or more in length is clas- (iv) Root system: A long primary sified as normal. root with secondary roots. (2) Abnormal seedling description. (2) Abnormal seedling description. (i) Shoot: (i) Cotyledons: (A) Missing. (A) For garden bean (Phaseolus (B) Short, thick, and grainy. vulgaris in part), remove any attached (C) No leaf. seed coats at the end of the test period (D) Leaf extending less than halfway for evaluation of cotyledons: up into the coleoptile. (1) Less than half of the original cot- (E) Leaf extensively shredded or yledon tissue remaining attached. split. (2) Less than half of the original cot- (F) Spindly or watery. yledon tissue free of necrosis or decay. (G) Deep open cracks in the (B) All other kinds: mesocotyl. (ii) Root: (1) Both missing and the seedling (A) Missing or defective primary root generally weak. even if other roots are present. (2) [Reserved] (B) Spindly, stubby, or watery pri- (ii) Epicotyl: mary root. (A) Missing. (iii) Seedling: (B) Deep open cracks. (A) Decayed at point of attachment (C) Malformed, such as markedly to the scutellum. curled or thickened. (B) One or more essential structures (D) Less than one primary leaf. impaired as a result of decay from pri- (E) Primary leaves too small in pro- mary infection. portion to the rest of the seedling, usu- (C) Albino. ally associated with visible defects of, (D) Yellow (when grown in light). or damage to, the main stem of the (E) Endosperm obviously detached epicotyl. from the root-shoot axis (e.g. kernel (F) Terminal bud missing or dam- lifted away by the growing shoot). aged. (If a few seedlings with total or [59 FR 64501, Dec. 14, 1994, as amended at 65 partial decay to the epicotyl are found, FR 1708, Jan. 11, 2000] they may be classified as normal, pro- vided the hypocotyl and root are nor- § 201.56–6 Legume or pea family, mal. The epicotyl on such seedlings Fabaceae (Leguminosae). usually does not decay when grown in a Kinds of seed: Alfalfa, alyceclover, fairly dry environment and exposed to asparagusbean, beans (Phaseolus spp.), light. A retest, preferably in soil or Florida beggarweed, black medic, sand, will aid in interpretation of such broadbean, burclovers, buttonclover, seedlings.) chickpea, clovers (Trifolium spp.), (iii) Hypocotyl: cowpea, crotalarias, crownvetch, guar, (A) Deep open cracks extending into hairy indigo, kudzu, lentil, lespedezas, the conducting tissue. (A healed break, lupines, northern sweetvetch, peas, sometimes referred to as a ‘‘knee,’’ is peanut, roughpea, sainfoin, sesbania, considered normal.) sourclover, soybean, sweetclovers, (B) Malformed, such as markedly trefoils, velvetbean, and vetches. shortened, curled, or thickened. (a) Field bean, garden bean, lima (Hypocotyl stunting or curling may be bean, mung bean, asparagusbean, and caused by seedling orientation or con- cowpea. striction on or in the substratum.) (1) General description. (Hypocotyl collar rot is the breakdown (i) Germination habit: Epigeal dicot. of hypocotyl tissue initially character- (ii) Food reserves: Cotyledons which ized by a watery appearance and col- are large and fleshy. lapse of the hypocotyl below the (iii) Shoot system: The hypocotyl cotyledonary node. The area later be- elongates and carries the cotyledons comes discolored, shrivelled, and ne- above the soil surface. The epicotyl crotic. The condition is caused by in- elongates, causing the terminal bud to sufficient calcium available to the
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seedling. If hypocotyl collar rot is ob- (A) Less than half of the original tis- served on seedlings of garden bean, the sue remaining attached. sample involved shall be retested in ac- (B) Less than half of the original tis- cordance with § 201.58(b)(12).) sue free of necrosis or decay. (iv) Root: (ii) Epicotyl: (A) None. (A) Missing. (B) Weak, stubby, or missing primary (B) Less than one primary leaf. root with weak secondary or adven- (C) Malformed such as markedly titious roots. (A root bound within a shortened, curled, or thickened. tough seed coat is considered normal.) (D) Severely damaged (e.g. terminal (v) Seedling: bud missing or damaged) with only a (A) One or more essential structures weak shoot developing from the axil of impaired as the result of decay from a cotyledon or scale leaf. primary infection. (Secondary infec- (E) Two weak and spindly shoots. tion is common in towel and blotter (F) Deep open cracks extending into tests. Some pathogens, such as Fusar- the conducting tissue. ium, Phomopsis, and Rhizoctonia, can (iii) Root: spread through the substratum and in- (A) None. fect seedlings some distance away from (B) Weak, stubby, or missing primary the primary source. Seedlings with sec- root with weak secondary roots. ondary infection are to be classified as (iv) Seedlings: normal. A retest in sand or soil may be (A) One or more essential structures advisable.) impaired as a result of decay from pri- mary infection. (Secondary infection is (B) Albino. common in towel and blotter tests. (b) Adzuki bean, broadbean, Some pathogens can spread through chickpea, field pea, lentil, pea, the substratum and infect seedlings roughpea, runner bean, velvetbean, and some distance away from the primary vetches. source. Seedlings with secondary infec- (1) General description. tion are classified as normal. A retest (i) Germination habit: Hypogeal in sand or soil may be advisable.) dicot. (B) Albino. (ii) Food reserves: Cotyledons which (c) Soybean and lupine. are large and fleshy, and remain en- (1) General description. closed within the seed coat beneath the (i) Germination habit: Epigeal dicot. soil surface. They are usually not pho- (ii) Food reserves: Cotyledons, which tosynthetic. are large and fleshy; they expand and (iii) Shoot system: The epicotyl elon- become photosynthetic. gates and carries the terminal bud and (iii) Shoot system: The hypocotyl primary leaves above the soil surface. elongates and carries the cotyledons The stem bears one or more scale above the soil surface. The primary leaves and, prior to emergence, is leaves usually increase in size and the arched near the apex, causing the ter- epicotyl may elongate within the test minal bud to be pulled through the period. soil; after emergence, the stem (iv) Root system: A long primary straightens. For practical purposes, the root with secondary roots. hypocotyl is not discernible and is not (2) Abnormal seedling description. an evaluation factor. Buds in the axils (i) Cotyledons: of each cotyledon and scale leaf usu- (A) Less than half of the original cot- ally remain dormant unless the ter- yledon tissue remaining attached. minal bud is seriously damaged. In this (B) Less than half of the original cot- case, one or more axillary buds may yledon tissue free of necrosis or decay. start to develop into a shoot. If the ax- (ii) Epicotyl: illary shoot is well-developed, it may (A) Missing. be considered normal. (B) Less than one primary leaf. (iv) Root system: A long primary (C) Deep open cracks. root with secondary roots. (D) Terminal bud damaged, missing, (2) Abnormal seedling description. or decayed. (If a few seedlings with par- (i) Cotyledons: tial decay of the epicotyl are found,
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they may be classified as normal, pro- (iii) Shoot system: The cotyledons vided the hypocotyl and root are nor- are carried to the soil surface by the mal. The epicotyl on such seedlings hypocotyl which is very thick, nar- usually does not decay when grown in a rowing abruptly at the root. Elon- fairly dry environment and is exposed gation of the hypocotyl stops when the to light. A retest, preferably in soil or epicotyl is exposed to light at the soil sand, will aid in interpretation of such surface. The primary leaves are com- seedlings.) pound and usually expand during the (iii) Hypocotyl: test period. (A) Deep open cracks extending into (iv) Root system: A long primary the conducting tissue. (Adventitious root with secondary roots. Adven- roots may occur at the site of injury, titious roots develop from the base of particularly on the hypocotyl and near the hypocotyl if the primary root is the base of the cotyledons. The seed- damaged. ling is classified as normal if the injury (2) Abnormal seedling description. is healed over and other essential (i) Cotyledons: structures are normal.) (A) Less than half of the original cot- (B) Malformed, such as markedly yledon tissue remaining attached. shortened, curled, or thickened. (B) Less than half of the original cot- (Hypocotyl development is slow until yledon tissue free of necrosis or decay. the roots start functioning. Caution (ii) Epicotyl: should be exercised to ensure slow (A) Missing. seedlings are not classified as abnor- (B) Less than one primary leaf. mal. Hypocotyl stunting or curling (C) Deep open cracks. also may be caused by seedling orienta- (D) Terminal bud damaged, missing, tion or constriction on or in the sub- or decayed. stratum.) (iii) Hypocotyl: (iv) Root: (A) Deep open cracks extending into (A) None. the conducting tissue. (B) Weak, stubby, or missing primary (B) Malformed, such as markedly root with weak secondary or adven- shortened or curled. (Hypocotyls re- titious roots. (Roots of seedlings on main somewhat thickened and may ap- ‘‘Kimpak’’ with insufficient moisture pear to be stunted. Light, depth of may not become established and planting, and substratum moisture all hypocotyl elongation may appear to be contribute to the length of the abnormal. There may be curling of the hypocotyl. Hypocotyl stunting or curl- root and hypocotyl. When a number of ing may be caused by seedling orienta- seedlings are observed with this condi- tion or constriction in the substratum. tion, the sample should be retested.) Seedlings planted in a soil test with (v) Seedlings: the radicle too close to the surface may (A) One or more essential structures send roots above the soil and appear to impaired as a result of decay from pri- exhibit negative geotropism and a dis- mary infection. (Secondary infection is torted, U-shaped hypocotyl. common in towel and blotter tests. (iv) Root: Some pathogens, such as Fusarium, (A) None. Phomopsis, and Rhizoctonia, can spread (B) Weak, stubby, or missing primary through the substratum and infect root with weak secondary or adven- seedlings some distance away from the titious roots. primary source. Seedlings with sec- (v) Seedling: ondary infection are to be classified as (A) One or more essential structures normal. A retest in sand or soil may be impaired as a result of primary infec- advisable.) tion. (B) Albino. (B) Albino. (d) Peanut. (e) Alfalfa, alyceclover, Florida (1) General description. beggarweed, black medic, burclovers, (i) Germination habit: Epigeal dicot. buttonclover, milkvetch, clovers, (ii) Food reserves: Cotyledons, which crotalarias, crownvetch, guar, hairy in- are large and fleshy. digo, kudzu, lespedezas, northern
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sweetvetch, sainfoin, sesbania, in soil, such seedlings are classified as sourclover, sweetclovers, and trefoils. normal. Roots may appear stubby as a (1) General description. result of being bound by the seed coat; (i) Germination habit: Epigeal dicot. such seedlings are classified as normal. (ii) Food reserve: Cotyledons, which Crownvetch produces phytotoxic ef- are small and fleshy; they expand and fects similar to sweetclovers.) become photosynthetic. The cotyledons (C) Split extending into the of sub clover develop elongated hypocotyl. petioles. (v) Seedling: (iii) Shoot system: The hypocotyl (A) One or more essential structures elongates and carries the cotyledons impaired as a result of decay from pri- above the soil surface. The epicotyl mary infection. usually does not show any development (B) Albino. within the test period. [59 FR 64503, Dec. 14, 1994, as amended at 65 (iv) Root system: A long, tapering FR 1708, Jan. 11, 2000] primary root, usually with root hairs. Secondary roots may or may not de- § 201.56–7 Lily family, Liliaceae. velop within the test period, depending Kinds of seed: Asparagus, chives, on the kind. leek, onion, and Welsh onion. (2) Abnormal seedling description. (a) Asparagus. (i) Cotyledons: (1) General description. (A) Less than half of the original cot- (i) Germination habit: Hypogeal yledon tissue remaining attached. monocot. (Breaks at the point of attachment of (ii) Food reserves: Endosperm which the cotyledons to the hypocotyl are is hard, semi- transparent, and non- common in seeds which have been me- starchy; minor reserves in the coty- chanically damaged. It is important ledon. The endosperm surrounds the that seedlings not be removed during entire embryo. preliminary counts unless development (iii) Cotyledon: A single cylindrical is sufficient to allow the conditions of cotyledon; following germination, all the cotyledons to be determined. If the but the basal end remains embedded in point of attachment of the cotyledons the endosperm to absorb nutrients. cannot be seen at the end of the test, (iv) Shoot system: The epicotyl elon- the seed coat should be peeled back to gates and carries the terminal bud determine whether a break has oc- above the soil surface. The epicotyl curred.) may bear several small scale leaves. A (B) Less than half of the original cot- short hypocotyl is barely distinguish- yledon tissue free of necrosis or decay. able, joining the root to the basal end (ii) Epicotyl: of the cotyledon. More than one shoot (A) Missing. (May be assumed to be may arise simultaneously, and the present if both cotyledons are intact.) seedling may be considered normal if (B) [Reserved] at least one shoot is well- developed (iii) Hypocotyl: and has a terminal growing point, pro- (A) Deep open cracks extending into vided other essential structures are the conducting tissue. normal. (B) Malformed, such as markedly (v) Root system: A long slender pri- shortened, curled, or thickened. (Seed- mary root. lings of sainfoin which have been con- (2) Abnormal seedling description. stricted by growing through the net- (i) Cotyledon: ting of the pod, but which are other- (A) Detached from seedling. wise normal, are classified as normal.) (B) Deep open cracks at basal end. (C) Weak and watery. (ii) Epicotyl: (iv) Root: (A) Missing. (A) None. (B) Terminal bud missing or dam- (B) Primary root stubby. (The roots aged. of sweetclovers may be stubby when (C) Deep open cracks. grown on artificial substrata due to the (D) Malformed, such as markedly presence of coumarin in the seed; since shortened, curled, or thickened. this condition usually does not occur (E) Spindly.
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(F) Watery. (iv) Root: (iii) Hypocotyl: (A) No primary root. (A) Deep open cracks. (B) Short, weak, or stubby primary (B) [Reserved] root. (iv) Root: (v) Seedling: (A) No primary root. (A) One or more essential structures (B) Stubby primary root with weak impaired as a result of decay from pri- secondary roots. mary infection. (v) Seedling: (B) Albino. (A) One or more essential structures impaired as a result of decay from pri- [59 FR 64504, Dec. 14, 1994] mary infection. (B) Albino. § 201.56–8 Flax family, Linaceae. (b) Chives, leek, onion, Welsh onion. Kind of seed: Flax. (1) General description. (a) General description. (i) Germination habit: Epigeal (1) Germination habit: Epigeal dicot. monocot. (Due to the mucilaginous nature of the (ii) Food reserves: Endosperm which is hard, semi-transparent, and non- seed coat, seedlings germinated on starchy; minor reserves in the coty- blotters may adhere to the blotter and ledon. appear to be negatively geotropic.) (iii) Cotyledon: A single cylindrical (2) Food reserves: Cotyledons which cotyledon. The cotyledon emerges with expand and become photosynthetic. the seed coat and endosperm attached (3) Shoot system: The hypocotyl to the tip. A sharp bend known as the elongates carrying the cotyledons ‘‘knee’’ forms; continued elongation of above the soil surface. The epicotyl the cotyledon on each side of this knee usually does not show any development pushes it above the soil surface. The within the test period. cotyledon tip is pulled from the soil (4) Root system: A primary root, with and straightens except for a slight secondary roots usually developing kink which remains at the site of the within the test period. knee. (b) Abnormal seedling description. (iv) Shoot system: The first foliage (1) Cotyledons: leaf emerges through a slit near the (i) Less than half of the original cot- base of the cotyledon, but this does not yledon tissue remaining attached. usually occur during the test period. (ii) Less than half of the original cot- The hypocotyl is a very short transi- yledon tissue free of necrosis or decay. tional zone between the primary root (2) Epicotyl: and the cotyledon, and is not distin- (i) Missing. (May be assumed to be guishable for purposes of seedling eval- present if cotyledons are intact.) uation. (v) Root system: A long slender pri- (ii) [Reserved] mary root with adventitious roots de- (3) Hypocotyl: veloping from the hypocotyl. The pri- (i) Deep open cracks extending into mary root does not develop secondary the conducting tissue. roots. (ii) Malformed, such as markedly (2) Abnormal seedling description. shortened, curled, or thickened. (i) Cotyledon: (4) Root: (A) Short and thick. (i) None. (B) Without a definite bend or (ii) Weak, stubby, or missing primary ‘‘knee’’. root with weak secondary or adven- (C) Spindly or watery. titious roots. (ii) Epicotyl: (5) Seedling: (A) Not observed during the test pe- (i) One or more essential structures riod. impaired as a result of decay from pri- (B) [Reserved] mary infection. (iii) Hypocotyl: (ii) Albino. (A) Not evaluated. (B) [Reserved] [59 FR 64505 Dec. 14, 1994]
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§ 201.56–9 Mallow family, Malvaceae. (1) Germination habit: Epigeal dicot. Kinds of seed: Cotton, kenaf, and (2) Food reserves: Cotyledons, which okra. are thin and leaf-like; endosperm (a) General description. (fleshy food-storage organs) usually (1) Germination habit: Epigeal dicot. persisting in the laboratory test. (2) Food reserve: Cotyledons, which (3) Shoot system: The hypocotyl are convoluted in the seed; they expand lengthens, carrying the cotyledons, and become thin, leaf-like, and photo- endosperm, and epicotyl above the soil synthetic. surface. (3) Shoot system: The hypocotyl (4) Root system: A primary root, with elongates carrying the cotyledons secondary roots usually developing above the soil surface. The epicotyl within the test period. usually does not show any development (b) Abnormal seedling description. within the test period. Areas of yel- (1) Cotyledons: lowish pigmentation may develop on (i) Less than half of the original cot- the hypocotyl in cotton. yledon tissue remaining attached. (4) Root system: A primary root, with (ii) Less than half of the original cot- secondary roots usually developing yledon tissue free of necrosis or decay. within the test period. Areas of yel- (2) Endosperm: lowish pigmentation may develop on (i) Missing. the root in cotton. (ii) [Reserved] (b) Abnormal seedling description. (3) Epicotyl: (1) Cotyledons: (i) Missing. (i) Less than half of the original cot- (ii) Damaged or missing terminal yledon tissue remaining attached. bud. (ii) Less than half of the original cot- (4) Hypocotyl: yledon tissue free of necrosis or decay. (i) Deep open cracks extending into (Remove any attached seed coats at the conducting tissue. the end of the test period for evalua- (ii) Malformed, such as markedly tion of cotyledons.) shortened, curled, or thickened. (2) Epicotyl: (5) Root: (i) Missing. (May be assumed to be (i) None. present if both cotyledons are intact.) (ii) Weak, stubby, or missing primary (ii) [Reserved] root with weak secondary or adven- (3) Hypocotyl: titious roots. (i) Deep open cracks or grainy lesions (6) Seedling: extending into the conducting tissue. (i) One or more essential structures (ii) Malformed, such as markedly impaired as a result of decay from pri- shortened, curled, or thickened. mary infection. (4) Root: (ii) Albino. (i) None. [59 FR 64505 Dec. 14, 1994] (ii) Weak, stubby, or missing primary root with weak secondary or adven- § 201.56–11 Knotweed family, titious roots. Polygonaceae. (5) Seedling: Kinds of seed: Buckwheat, rhubarb, (i) One or more essential structures and sorrel. impaired as a result of decay from pri- (a) General description. mary infection. (A cotton seedling with (1) Germination habit: Epigeal dicot. yellowish areas on the root or (2) Food reserves: Cotyledons, hypocotyl is classified as normal, pro- starchy endosperm. vided the cotyledons are free of infec- (3) Shoot system: The hypocotyl tion.) elongates carrying the cotyledons (ii) Albino. above the soil surface. The epicotyl [59 FR 64505 Dec. 14, 1994] usually does not show any development within the test period. § 201.56–10 Spurge family, (4) Root system: A primary root, with Euphorbiaceae. secondary roots developing within the Kind of seed: Castorbean. test period for some kinds. (a) General description. (b) Abnormal seedling description.
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(1) Cotyledons: within the test period, depending on (i) Less than half of the original cot- the kind. yledon tissue remaining attached. (b) Abnormal seedling description. (ii) Less than half of the original cot- (1) Cotyledons: yledon tissue free of necrosis or decay. (i) Less than half of the original cot- (2) Epicotyl: yledon tissue remaining attached. (i) Missing. (May be assumed to be (ii) Less than half of the original cot- present if cotyledons are intact.) yledon tissue free of necrosis or decay. (ii) [Reserved] (2) Epicotyl: (3) Hypocotyl: (i) Missing. (May be assumed to be (i) Deep open cracks or grainy lesions present if the cotyledons are intact.) extending into the conducting tissue. (ii) [Reserved] (ii) Malformed, such as markedly (3) Hypocotyl: shortened, curled, or thickened. (i) Malformed, such as markedly (iii) Watery. shortened, curled, or thickened. (4) Root: (ii) Deep open cracks extending into (i) None. the conducting tissue. (ii) Weak, stubby, or missing primary (iii) Watery. root with weak secondary or adven- (4) Root: titious roots. (i) None. (5) Seedling: (ii) Missing or stubby primary root (i) One or more essential structures with weak secondary or adventitious impaired as a result of decay from pri- roots. mary infection. (5) Seedling: (ii) Albino. (i) One or more essential structures [59 FR 64506, Dec. 14, 1994] impaired as a result of decay from pri- mary infection. § 201.56–12 Miscellaneous plant fami- (ii) Albino. lies. [59 FR 64506, Dec. 14, 1994] Kinds of seed by family: Carrot family, Apiaceae § 201.57 Hard seeds. (Umbelliferae)—carrot, celery, celeriac, Seeds which remain hard at the end dill, parsley, parsnip; of the prescribed test because they Hemp family, Cannabaceae—hemp; Dichondra family, Dichondraceae— have not absorbed water, due to an im- dichondra; permeable seed coat, are to be counted Geranium family, Geraniaceae— as ‘‘hard seed.’’ If at the end of the ger- alfilaria; mination period provided for legumes, Mint family, Lamiaceae (Labiatae)— okra, cotton and dichondra in these sage, summer savory; benne family, rules and regulations there are still Pedaliaceae—sesame; present swollen seeds or seeds of these Rose family, Rosaceae—little burnet; kinds which have just started to ger- Nightshade family, Solanaceae—egg- minate, all seeds or seedlings except plant, tomato, husk tomato, pepper, the above-stated shall be removed and tobacco; and the test continued for 5 additional days Valerian family, Valerianaceae— and the normal seedlings included in cornsalad. the percentage of germination. For (a) General description. flatpea, continue the swollen seed in (1) Germination habit: Epigeal dicot. test for 14 days when germinating at ° (2) Food reserves: Cotyledons; 15–25 C or for 10 days when germi- ° endosperm may or may not be present, nating at 20 C. depending on the kind. [5 FR 33, Jan. 4, 1940, as amended at 10 FR (3) Shoot system: The hypocotyl 9952, Aug. 11, 1945; 20 FR 7936, Oct. 21, 1955; 65 elongates, carrying the cotyledons FR 1708, Jan. 11, 2000] above the soil surface. The epicotyl usually does not show any development § 201.57a Dormant seeds. within the test period. Dormant seeds are viable seeds, other (4) Root system: A primary root; sec- than hard seeds, which fail to ger- ondary roots may or may not develop minate when provided the specified
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germination conditions for the kind of shall be 75 to 125 foot-candles (750–1,250 seed in question. lux). (The light intensity for nondor- (a) Viability of ungerminated seeds mant seed and during seedling develop- shall be determined by any of the fol- ment may be as low as 25 foot-candles lowing methods or combinations of to enable the essential structures to be methods: a cutting test, tetrazolium evaluated with greater certainty.) The test, scarification, or application of seeds shall be illuminated for at least 8 germination promoting chemicals. hours every 24 hours except when (b) The percentage of dormant seed, transferred to a low temperature ger- if present, shall be determined in addi- minator during the weekend. When tion to the percentage of germination seeds are germinated at alternating for the following kinds: Bahiagrass, temperatures they shall be illuminated basin wildrye, big bluestem, little during high temperature periods. Seeds bluestem, sand bluestem, yellow for which light is prescribed shall be bluestem, bottlebrush-squirreltail, germinated on top of the substratum buffalograss, buffelgrass, galletagrass, except for ryegrass fluorescence tests. forage kochia, blue grama, side-oats (3) Moisture-on-dry-side. This term grama, Indian ricegrass, johnsongrass, means that the moistened substratum sand lovegrass, weeping lovegrass, should be pressed against a dry absorb- mountain rye, sand dropseed, smilo, ent surface such as a dry paper towel switchgrass, veldtgrass, western or blotter to remove excess moisture. wheatgrass, and yellow indiangrass. The moisture content thus obtained (c) For green needlegrass, if the test should be maintained throughout the result of method 2 is less than the re- germination test period. sult of method 1, subtract the result of (4) Potassium nitrate (KNO3). These method 2 from method 1 and report the terms mean a two-tenths (0.2) percent difference as the percentage of dor- solution of potassium nitrate (KNO3) mant seed. Refer to § 201.58(b)(7). shall be used in moistening the sub- [46 FR 53638, Oct. 29, 1981, as amended at 59 stratum. Such solution is prepared by FR 64506, Dec. 14. 1994] dissolving 2 grams of KNO3 in 1,000 ml. of distilled water. The grade of the po- § 201.58 Substrata, temperature, dura- tassium nitrate shall meet A.C.S. spec- tion of test, and certain other spe- ifications. cific directions for testing for ger- (5) Prechill. The term ‘‘prechill’’ mination and hard seed. means a cold, moist treatment applied Specific germination requirements to seeds to overcome dormancy prior to are set forth in table 2 to which the fol- the germination test. The prechill lowing paragraphs (a), (b), and (c) are method varies among kinds, but is usu- applicable. ally performed by holding imbibed (a) Definitions and explainations appli- seeds at a low temperature for a speci- cable to table 2—(1) Duration of tests. The fied period of time. The prechill period following deviations are permitted is not included in the duration of tests from the specified duration of tests: given in table 2, unless otherwise speci- Any test may be terminated prior to fied. the number of days listed under ‘‘Final (6) Predry. The term ‘‘predry’’ means count’’ if the miximum germination of to place the seed in a shallow layer at the sample has then been determined. a temperature of 35 ° to 40 °C. for a pe- The number of days stated for the first riod of 5 to 7 days, with provisions for count is approximate and a deviatioon circulation of the air. of 1 to 3 days is permitted. If at the (7) Substrata (Kinds). The symbols time of the prescribed test period the used for substrata are: seedlings are not sufficiently developed B= between blotters for positive evaluation, it is possible to TB= top of blotters extend the time of the test period two T= paper toweling, used either as fold- additional days. (Also, see paragraph ed towel tests or as roll towel tests (a)(5) of this section and 201.57.) in horizontal or vertical position (2) Light. Cool white fluorescent light S= sand or soil where soil is an artifi- shall be provided where light is re- cial planting mix of shredded peat quired in table 2. The light intensity moss, vermiculite, and perlite
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TS= top of sand or soil solution with 5,000 ml of distilled P= covered Petri dishes: with two lay- water. The stock solution contains 24 ers of blotters; with one layer of grams of active material per 100 ml of absorbent cotton; with five layers propylene glycol or two pounds of ac- of paper toweling; with three tive material per gallon. A solution thicknesses of filter paper; or with which is five times this concentration sand or soil (5 x 29 ppm) may be used for extremely C= creped cellulose paper wadding (0.3- dormant seeds, provided seeds are inch thick Kimpak or equivalent) transferred to substratum moistened covered with a single thickness of with water after 1 to 3 days. blotter through which holes are (11) Ethylene. This term means that punched for the seed that are five (5) ml of ethylene gas per cubic pressed for about one-half their foot (176.57 ml/m3) of germinator space thickness into the paper wadding is injected into a germinator in which TC= on top of creped cellulose paper peanut seeds in moist rolled towels without a blotter have been placed. Following injection RB= blotters with raised covers, pre- of the ethylene, the germinator is kept pared by folding up the edges of the closed until the first count (5 days). If blotter to form a good support for the germinator door is opened for the the upper fold which serves as a purpose of checking or rewetting the cover, preventing the top from samples, another injection of ethylene making direct contact with the at the same rate shall be made. seeds. (b) Special procedures and alternate (8) Temperature. A single numeral in- methods for germination referred to in dicates a constant temperature. Two table 2—(1) Alyceclover; swollen seeds. At numerals separated by a dash indicate the conclusion of the 21-day test pe- an alternation of temperature, the test riod, carefully pierce the seed coat to be held at the first temperature for with a sharp instrument and continue approximately 16 hours and at the sec- the test for 5 additional days. Alter- ond temperature for approximately 8 nate method: The swollen seeds may be hours per day. The temperature shall placed at 20 °C for 48 hours and then at be determined at the substratum level 35 °C for 3 additional days. and shall be as uniform as possible throughout the germination chamber. (2) Bahiagrass; removal of glumes. On (A sharp alternation of temperature, all varieties except ‘‘Pensacola,’’ re- such as obtained by hand transfer, may move the enclosing structures (glumes, be beneficial in breaking dormancy.) If lemma, and palea) from the caryopsis tests are not subjected to alternating with the aid of a sharp scalpel. If the temperatures over weekends and on seed is fresh or dormant, lightly holidays, they are to be held at the scratch the surface of the caryopsis. first-mentioned temperature during (3) Beet, Swiss chard; preparation of this time. In cases where two tempera- seed for test. Before the seeds are placed tures are indicated (separated by a on the germination substratum, they semicolon) the first temperature shall shall be soaked in water for 2 hours, be regarded as the regular method and using at least 250 ml of water per 100 the second as an alternate method. seeds, then washed in running water (9) Paper substrata must be free of and the excess water blotted off. The chemicals toxic to germinating seed temperature of the soaking and wash- and seedling growth. If root injury oc- ing water should be no lower than 20 °C. curs from toxicity of a paper sub- Samples producing excessive discolora- stratum or from the use of potassium tion of the hypocotyl or root should be nitrate, retests shall be made on soil or retested in soil or by washing in run- on a substratum moistened with water. ning water for 3 hours and testing on (10) Ethephon. This term means a 29 ‘‘Kimpak,’’ keeping the seed covered parts per million (0.0029 percent) solu- with slightly moist blotters. Sugar tion of ethephon [(2-chloroethyl) phos- beets may require 16 hours soaking in phonic acid] which shall be used to water at 25 °C, followed by rinsing and moisten the substratum. This solution then drying for 2 hours at room tem- is prepared by mixing 0.6 ml of a stock perature.
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(4) Buffelgrass; alternate method for Dormant seeds: Presoak 24 to 48 hours dormant seed. The caryopses shall be re- in 40 °C. water. For deeply dormant moved from the fascicles and placed on seeds, presoak 24 hours in 1,000 p.p.m. blotters moistened with a 0.2 percent ethylene chlorohydrin or 5 percent so- solution of KNO3, in petri dishes. The lution of sodium hypochlorite (clorox seeds from a fascicle should be ar- at bottle strength). ranged so they will not be confused (10) Ryegrass; fluorescence test. The with seeds from other fascicles during germination test for fluorescence of the test. The seeds are then prechilled ryegrass shall be conducted in light at 5 °C for 7 days and tested at 30 °C in [not to exceed 100 foot candles (1,076 light for 21 additional days. Firm lux)] with white filter paper as the sub- ungerminated seeds remaining at the stratum. The white filter paper should conclusion of the test should be be nontoxic to the roots of ryegrass scratched lightly and left in test for 7 and of a texture that will resist pene- additional days. tration of ryegrass roots. Distilled or (5) Cotton (Gossypium spp.); dormant deionized water shall be used to moist- samples. Samples of cottonseed which en the filter paper. The test shall be do not respond to the usual method conducted in a manner that will pre- should be placed in a closed container vent the contact of roots of different with water and shaken until the lint is seedlings. Roots of some seedlings thoroughly wet. The excess moisture produce fluorescent lines on white fil- should then be blotted off. ter paper when viewed under ultra- (6) Endive (Cichorium endivia); dormant violet light. First counts shall not be samples. Add about 1⁄8 inch of tap water made before the eighth day; at that at the beginning of the test and remove time remove only normal fluorescent excess water after 24 hours. seedlings. Evaluation of fluorescence (7) Green needlegrass; two test meth- shall be made under F15T8–BLB or ods as prescribed in table 2 shall be comparable ultraviolet tubes in an area used on each sample: where light from other sources is ex- (i) For method 1, acid scarify 400 cluded. If there are over 75 percent nor- seeds for 10 minutes in concentrated mal fluorescent seedlings present at sulfuric acid (95 to 98 percent H2 SO4). the time of the first count, break the Rinse seeds and dry on blotters for 16 contact of the roots of the nonfluores- hours, then place seeds on blotters cent seedlings from the substratum and moistened with a solution of 0.055 per- reread the fluorescence at the time of cent (500 ppm gibberellic acid GA3) and the final count. At the final count, lift 0.46 percent (3,000 ppm) thiram and ger- each remaining seedling, observing the minate 14 days. path of each root since sometimes faint (ii) For method 2, plant 400 seeds on fluorescence will show on the sub- blotters moistened with a 0.2 percent stratum as the root is lifted. Abnormal solution of KNO3 and germinate 14 seedlings and dead seeds are not evalu- days. Refer to § 201.57a(c). ated for fluorescence. See § 201.58a(a). (iii) Report the results of method 2 as (11) Trifolium, Medicago, Melilotus, and the percentage germination. If the Vicia faba; temperature requirements. A number in method 2 is less than meth- temperature of 18 °C. is desirable for od 1, subtract the results of method 2 Trifolium spp., Medicago spp., Melilotus from method 1 and report the dif- spp., and Vicia faba. ference as dormant seed. (12) Garden bean; use of calcium ni- (8) Rescue grass (Bromus catharticus); trate. If hypocotyl collar rot is observed dormant samples. Wash for 48 hours in on seedlings, the sample involved shall running water, or soak for 48 hours, be retested using a 0.3 to 0.6 percent so- changing the water and rinsing each lution of calcium nitrate (CaNO3) to morning and night. moisten the substratum. (9) Rice (Oryza sativa)—Alternate meth- (13) Fourwing Saltbush (Atriplex od. Plant the seeds in moist sand. On canscens); preparation of seed for test. the seventh day of the test add water DE-wing seeds and soak for 2 hours in to a depth of one-fourth inch above the 3 leters of water after which rince with sand level and leave for the remainder approximately 3 leters of distilled of the test. Only a final count is made. water. Remove excess water, air dry for
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7 days at room temperature, then test (iii) Coated seed units in mixtures for germination as indicated in Table 2. which cannot be separated by kinds (c) Procedures for coated seed: without removing the coating material (1) Germination tests on coated seed shall be de-coated and germinated as shall be conducted in accordance with separate kinds. The coating material methods in paragraphs (a) and (b) of shall be removed in a manner that will this section. However, kinds for which not affect the germination capacity of soaking or washing is specified in para- the seeds. graph (b) shall not be soaked or washed (2) The moisture level of the sub- in the case of coated seed. (i) Coated seed units shall be placed stratum is important. It may depend on the substratum in the condition in on the water-absorbing capacity of the which they are received without rins- coating material. A retest may be nec- ing, soaking, or any other essary before satisfactory germination pretreatment. of the sample is achieved. (ii) Coated seed units in mixtures (3) Phytotoxic symptoms may be evi- which are color coded or can otherwise dent when germinating coated seeds in be separated by kinds shall be ger- paper substrata. In such cases a retest minated as separate kinds without re- in sand or soil may be necessary. moving the coating material.
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[20 FR 7928, Oct 21, 1955] may be based upon the seedling, grow- EDITORIAL NOTE: For FEDERAL REGISTER ci- ing plant or mature plant characteris- tations affecting § 201.58, see the List of CFR tics according to such authentic infor- Sections Affected, which appears in the mation as is available. Finding Aids section of the printed volume (a) Ryegrass. In determining the pure and on GPO Access. seed percentage of perennial ryegrass and annual ryegrass, 400 seeds shall be EXAMINATIONS IN THE ADMINISTRATION grown on white filter paper and the OF THE ACT number of fluorescent seedlings deter- mined under ultraviolet light at the § 201.58a Indistinguishable seeds. end of the germination period (see When the identification of the kind, § 201.58(b)(10)). variety, or type of seed or determina- (1) Fluorescence results are to be de- tion that seed is hybrid is not possible termined as test fluorescence level by seed characteristics, identification (TFL) to two decimal places as follows:
Number of normal fluorescent seedlings % TFL = ×100 Total number of normal seedlings
(2) The percentage of perennial rye- grass is calculated as follows:
% VFL (annual)− % TFL % Perennial ryegrass = × % Pure ryegrass % VFL (annual)− %( VFL perennial )
where VFL=Variety fluorescence level. Official Seed Certifying Agencies (3) Using results from the above for- (AOSCA). If the variety being tested is mula, the percentage of annual rye- not stated or the fluorescence level has grass is calculated as follows: not been described, the fluorescence % Annual Ryegrass = % Pure Rye- level shall be considered to be 0 percent grass¥% Perennial Ryegrass for perennial ryegrass and 100 percent (4) If the test fluorescence level for annual ryegrass. Both VFL (annual) (TFL) of a perennial ryegrass is equal and VFL (perennial) values must al- to or less than the variety fluorescence ways be entered in the formula. If a pe- level (VFL) described for the variety, rennial ryegrass variety is being test- all pure ryegrass is considered to be pe- ed, the VFL (annual) value is 100 per- rennial ryegrass and the formula is not cent. If an annual ryegrass variety is applied. being tested, the VFL (perennial) value (5) If the test fluorescence level is 0 percent. For blends the fluores- (TFL) of an annual ryegrass is equal to cence level shall be interpolated ac- or greater than the variety fluores- cording to the portion of each variety cence level (VFL) described for the va- claimed to be present. riety, all pure ryegrass is considered to (b) Sweetclover. To determine the be annual ryegrass and the formula is presence of yellow sweetclover in sam- not applied. ples of white sweetclover, at least 400 (6) A list of variety fluorescence level seeds shall be subjected to the chem- (VFL) descriptions for perennial rye- ical test as follows: grass varieties which are more than 0 (1) Preparation of test solution: Add 3 percent fluorescent and annual rye- grams of cupric sulfate (CuSO4) to 30 grass varieties which are less than 100 ml of household ammonia (NH4 OH, ap- percent fluorescent is maintained and proximately 4.8 percent) in a stoppered published by the National Grass Vari- bottle to form tetraamminecopper sul- ety Review Board of the Association of fate ([Cu(NH3)4]SO4) solution used for 357
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this test. After mixing, a light blue (5) Brown Black. precipitate of cupric hydroxide (d) Soybean. In determining the vari- (Cu(OH)2) should form. If no precipitate etal purity, the peroxidase test may be forms, add additional CuSO4 until a used. Remove and place the dry seed precipitate appears. Since the strength coat from seeds into individual test of household ammonia can vary, forma- tubes or suitable containers. Add 10 tion of a precipitate indicates that a drops (0.5–1.0 ml) of 0.5 percent guaiacol complete reaction has taken place be- (C7 H8 O2) to each test tube. After wait- tween CuSO4 and NH4 OH; otherwise ing 10 minutes add one drop (about 0.1 fumes from excess ammonium hydrox- ml) of 0.1 percent hydrogen peroxide ide may cause eye irritation. (H2 O2). One minute after adding hydro- (2) Preparation of seeds: To insure gen peroxide, record the seed coat as imbibition, scratch, prick, or otherwise peroxidase positive (high peroxidase scarify the seed coats of the activity) indicated by a reddish-brown sweetclover seeds being tested. Soak solution or peroxidase negative (low seeds in water for 2 to 5 hours in a glass peroxidase activity) indicated by a container. colorless solution in the test tube. Var- (3) Chemical reaction: When seeds ious sample sizes may be used for this have imbibed, remove excess water and test. Test results shall include the add enough test solution to cover the sample size tested. seeds. Seeds coats of yellow (e) Oat. In determining the varietal sweetclover will begin to stain dark purity, the fluorescence test may be brown to black; seed coats of white used. Place at least 400 seeds on a black sweetclover will be olive or yellow- background under a F15T8–BLB or green. Make the separation within 20 comparable ultraviolet tube(s) in an minutes, since the seed coats of white area where light from other sources is sweetclover will eventually turn black excluded. Seeds are considered fluores- also. cent if the lemma or palea fluoresce or (4) Calculation of results: Count the appear light in color. ‘‘Partially fluo- number of seeds which stain dark rescent’’ seeds shall be considered fluo- brown or black and divide by the total rescent. Seeds are considered non- number of seeds tested; multiply by the fluorescent if the lemma and palea do pure seed percentage for Melilotus spp.; not fluoresce and appear dark in color the result is the percentage of yellow under the ultraviolet light. sweetclover in the sample. The per- centage of white sweetclover is found [59 FR 64514, Dec. 14, 1994] by subtracting the percentage of yel- EDITORIAL NOTE: For Federal Register cita- low sweetclover from the percentage of tions affecting § 201.58a, see the List of CFR Melilotus spp. pure seed. Sections Affected, which appears in the (c) Wheat. In determining varietal Finding Aids section of the printed volume purity, the phenol test may be used. and on GPO Access. From the pure seed sample count four § 201.58b Origin. replicates of 100 seeds each. Soak the seed in distilled water for 16 hours; The presence of incidental weed then flush with tap water and remove seeds, foreign matter, or any other ex- the excess water from the surface of isting circumstances shall be consid- the seeds. Place two layers of filter ered in determining the origin of seed. paper in a container and moisten with [5 FR 35, Jan. 4, 1940. Redesignated at 20 FR a 1 percent phenol (C6 H5 OH) solution. 7940, Oct. 21, 1955] Place the seed, palea side down, on the two layers of filter paper and cover the § 201.58c Detection of captan, mercury, container. A preliminary observation or thiram on seed. may be made at 2 hours. At 4 hours, The bioassay method may be used ac- record the number of seeds in each of cording to the procedure given in Asso- the following color categories: ciation of Official Seed Analysts, Hand- (1) Ivory. book No. 26, ‘‘Microbiological Assay of (2) Fawn. Fungicide-treated Seeds’’, May 1964. (3) Light Brown. (4) Brown. [38 FR 12733, May 15, 1973]
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§ 201.58d Fungal endophyte test. saprophytes and should have as little chlorophyll as possible. A fungal endophyte test may be used (4) Isolate a longitudinal section of to determine the amount of fungal leaf sheath approximately 3–5 mm in endophyte (Acremonium spp.) in certain width. grasses. (5) Place the section on a microscope (a) Method of preparation of aniline slide with the epidermis side down. blue stain for use in testing grass seed (6) Stain immediately with the and plant material for the presence of endophyte staining solution as pre- fungal endophyte: pared in paragraph (a) (2) and (3) of this (1) Prepare a 1 percent aqueous ani- section. Allow dye to remain at least 15 line blue solution by dissolving 1 gram seconds but no more than one minute. aniline blue in 100 ml distilled water. (7) Blot off the excess dye with tissue (2) Prepare the endophyte staining paper. Sections should remain on the solution of one part of 1 percent aniline slide, but may adhere to the tissue blue solution with 2 parts of 85 percent paper; if so, remove and place in proper lactic acid (C3 H6 O3). position on the slide. (3) Use stain as-is or dilute with (8) Place a coverglass on the sections water if staining is too dark. and flood with water. (b) Procedure for determining levels (9) Proceed with evaluation as de- of fungal endophyte in grass seed: scribed in paragraph (b) (6) and (7) of (1) Take a sub-sample of seed (1 gram this section. is sufficient) from the pure seed por- [59 FR 64515, Dec. 14, 1994] tion of the kind under consideration. (2) Digest seed at room temperature TOLERANCES for 12–16 hours in a 5 percent sodium hydroxide (NaOH) solution or other § 201.59 Application. temperature/time combination result- Tolerances shall be recognized be- ing in adequate seed softening. tween the percentages or rates of oc- (3) Rinse thoroughly in running tap currence found by analysis, test, or ex- water. amination in the administration of the (4) De-glume seeds and place on a mi- act and percentages or rates of occur- croscope slide in a drop of endophyte rence required or stated as required by staining solution. Slightly crush the the act. Tolerances for purity percent- seeds. Use caution to prevent carryover ages and germination percentages pro- hyphae of fungal endophyte from one vided for in §§ 201.60 and 201.63 shall be seed to another. determined from the mean of (a) the (5) Place coverglass on seed and apply results being compared, or (b) the re- gentle pressure. sult found by test and the figures (6) Examine with compound micro- shown on a label, or (c) the result scope at 100–400x magnification, scor- found by test and a standard. All other ing a seed as positive if any identifi- tolerances, including tolerances for able hyphae are present. pure-live seed and fluorescence, and (7) Various sample sizes may be used tolerances for purity based on 10 to for this test. Precision changes with 1,000 seeds, seedlings, or plants shall be sample size; therefore, the test results determined from the result or results must include the sample size tested. found in the administration of the Act. (c) Procedure for determining levels [5 FR 34, Jan. 4, 1940, as amended at 20 FR of fungal endophyte in seedlings from 7940, Oct. 21, 1955; 24 FR 3954, May 15, 1959; 35 seed samples suspected to contain FR 6108, Apr. 15, 1970] fungal endophyte: (1) Select seeds at random and ger- § 201.60 Purity percentages. minate. (a)(1) The tolerance for a given per- (2) Examine seedlings from the sam- centage of the purity components is ple germinated after growing for a min- the same whether for pure seed, other imum of 48 days. crop seed, weed seed, or inert matter. (3) Remove the outermost sheath Wider tolerances are provided when 33 from the seedling. Tissue should have percent or more of the sample is com- no obvious discoloration from posed of seed plus empty florets and/or
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empty spikelets of the following chaffy TABLE 3—TOLERANCES FOR ANY COMPONENT kinds: bentgrasses, bermudagrasses, OF A PURITY ANALYSIS FOR (1) UNMIXED bluegrasses, bluestems, bottlebrush- SEED OR (2) MIXED SEED IN WHICH THE PAR- squirreltail, bromes, buffalograss, TICLE WEIGHT RATIO IS 1: 1 TO 1.49: 1, IN- buffelgrass, carpetgrass, soft chess, CLUSIVE—Continued dallisgrass, fescues, foxtails, Nonchaffy Chaffy galletagrass, guineagrass, gramas, Average analysis (A) (B) seeds (C) seeds (D) molassesgrass, tall oatgrass, orchardgrass, redtop, rescuegrass, 97.75Ð 97.99 ...... 2.00Ð 2.24 .87 1.01 97.50Ð 97.74 ...... 2.25Ð 2.49 .92 1.07 rhodesgrass, Indian ricegrass, 97.25Ð 97.49 ...... 2.50Ð 2.74 .96 1.12 ryegrasses, sweet vernalgrass, 97.00Ð 97.24 ...... 2.75Ð 2.99 1.00 1.17 vaseygrass, veldtgrass, wheatgrasses, 96.50Ð 96.99 ...... 3.00Ð 3.49 1.06 1.24 wildryes, and yellow indiangrass. The 96.00Ð 96.49 ...... 3.50Ð 3.99 1.14 1.34 95.50Ð 95.99 ...... 4.00Ð 4.49 1.21 1.41 wider tolerances do not apply to seed 95.00Ð 95.49 ...... 4.50Ð 4.99 1.27 1.49 devoid of hulls. 94.00Ð 94.99 ...... 5.00Ð 5.99 1.36 1.60 (2) To determine the tolerance for 93.00Ð 93.99 ...... 6.00Ð 6.99 1.47 1.73 any purity percentage found in the ad- 92.00Ð 92.99 ...... 7.00Ð 7.99 1.58 1.85 91.00Ð 91.99 ...... 8.00Ð 8.99 1.67 1.96 ministration of the act, the percentage 90.00Ð 90.99 ...... 9.00Ð 9.99 1.75 2.06 found is averaged (i) with that claimed 88.00Ð 89.99 ...... 10.00Ð11.99 1.87 2.19 or shown on a label or (ii) with a speci- 86.00Ð 87.99 ...... 12.00Ð13.99 2.01 2.36 84.00Ð 85.99 ...... 14.00Ð15.99 2.14 2.51 fied standard. The tolerance is found 82.00Ð 83.99 ...... 16.00Ð17.99 2.24 2.64 from this average. If more than one 80.00Ð 81.99 ...... 18.00Ð19.99 2.35 2.76 test is made, all except any test obvi- 78.00Ð 79.99 ...... 20.00Ð21.99 2.44 2.86 ously in error shall be averaged and the 76.00Ð 77.99 ...... 22.00Ð23.99 2.52 2.96 74.00Ð 75.99 ...... 24.00Ð25.99 2.59 3.04 result treated as a single percentage. 72.00Ð 73.99 ...... 26.00Ð27.99 2.65 3.12 (b) The tolerances found in columns 70.00Ð 71.99 ...... 28.00Ð29.99 2.71 3.19 C and D for the respective purity per- 65.00Ð 69.99 ...... 30.00Ð34.99 2.80 3.29 60.00Ð 64.99 ...... 35.00Ð39.99 2.89 3.40 centages shown in columns A and B of 50.00Ð 59.99 ...... 40.00Ð49.99 2.96 3.48 table No. 3 shall be used for (1) unmixed seed and (2) mixtures in which (c) Tolerances calculated by the fol- the particle-weight ratio is 1:1 to 1.49:1, lowing formula shall be used for either inclusive. Tolerances for intermediate chaffy or nonchaffy mixtures when the percentages not shown in table 3 shall average particle-weight ratio is 1.5:1 to be obtained by interpolation. 20:1 and beyond: The symbols used in the formula are TABLE 3—TOLERANCES FOR ANY COMPONENT as follows: OF A PURITY ANALYSIS FOR (1) UNMIXED T=tolerance being calculated. SEED OR (2) MIXED SEED IN WHICH THE PAR- A=percent which the weight of the TICLE WEIGHT RATIO IS 1: 1 TO 1.49: 1, IN- component with the heavier average CLUSIVE particle-weight is of the weight of both components. Average analysis (A) (B) Nonchaffy Chaffy seeds (C) seeds (D) B=percent which the weight of the 99.95Ð100.00 ...... 0.00Ð0.04 0.13 0.16 component with the lighter average 99.90Ð 99.94 ...... 05Ð .09 .20 .23 particle-weight is of the weight of 99.85Ð 99.89 ...... 10Ð .14 .24 .29 both components. 99.80Ð 99.84 ...... 15Ð .19 .28 .34 99.75Ð 99.79 ...... 20Ð .24 .32 .37 H=average particle-weight for the com- 99.70Ð 99.74 ...... 25Ð .29 .35 .41 ponent with the heavier average par- 99.65Ð 99.69 ...... 30Ð .34 .37 .45 ticle-weight. 99.60Ð 99.64 ...... 35Ð .39 .40 .48 L=average particle-weight for the com- 99.55Ð 99.59 ...... 40Ð .44 .42 .50 99.50Ð 99.54 ...... 45Ð .49 .44 .53 ponent with the lighter average par- 99.40Ð 99.49 ...... 50Ð .59 .47 .57 ticle-weight. 99.30Ð 99.39 ...... 60Ð .69 .51 .60 R=ratio of the average particle-weight 99.20Ð 99.29 ...... 70Ð .79 .54 .64 99.10Ð 99.19 ...... 80Ð .89 .57 .66 for the component with the heavier 99.00Ð 99.09 ...... 90Ð .99 .59 .70 average particle-weight to the aver- 98.75Ð 98.99 ...... 1.00Ð 1.24 .64 .75 age particle-weight for the compo- 98.50Ð 98.74 ...... 1.25Ð 1.49 .71 .82 98.25Ð 98.49 ...... 1.50Ð 1.74 .76 .89 nent with the lighter average par- 98.00Ð 98.24 ...... 1.75Ð 1.99 .82 .95 ticle-weight. R=H/L.
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100 R[]() 100 A/RBART//()+ − 1 T=A− []()100 B//()BAR+ + T 1+ R[]() 100 A/R //() BAR+ − T 1
T1=regular tolerance for the kind of PERCENT FOUND FLUORESCENCE TOLERANCE— seed (chaffy or nonchaffy) and for Continued (100B)/(B+A/R). 77 ...... 5.6 In determining the values for A and 76 ...... 5.7 B in the formula, the sample shall be 75 ...... 5.8 regarded as composed of two parts: 74 ...... 5.8 73 ...... 5.9 (1) The kind, type, or variety under 72 ...... 6.0 consideration, and 71 ...... 6.1 (2) All other components. Values for 70 ...... 6.2 H and L shall be obtained from the last 69 ...... 6.2 68 ...... 6.3 column of Table 1, § 201.46, or by labora- 67 ...... 6.3 tory tests for inert matter, weed seeds, 66 ...... 6.4 or crop seeds where such values are not 65 ...... 6.5 64 ...... 6.5 obtainable from Table 1. In computing 63 ...... 6.5 tolerances for nonchaffy kinds the val- 62 ...... 6.6 ues for T1 are taken from column C of 61 ...... 6.6 60 ...... 6.7 Table 3, and for chaffy kinds the values 59 ...... 6.7 for T1 are taken from column D of 58 ...... 6.8 Table 3. 57 ...... 6.8 56 ...... 6.8 [26 FR 10036, Oct. 26, 1961, as amended at 59 55 ...... 6.8 FR 64515, Dec. 14, 1994; 65 FR 1709, Jan. 11, 54 ...... 6.9 2000] 53 ...... 6.9 52 ...... 6.9 51 ...... 6.9 § 201.61 Fluorescence percentages in 50 ...... 6.9 ryegrasses. 49 ...... 6.9 48 ...... 6.9 Tolerances for 400-seed fluorescence 47 ...... 6.9 tests shall be those set forth in the fol- 46 ...... 6.9 lowing table plus one-half the regular 45 ...... 6.9 44 ...... 6.9 pure-seed tolerance determined in ac- 43 ...... 6.9 cordance with § 201.60. When only 200 42 ...... 6.9 seeds of a component in a mixture are 41 ...... 6.9 tested, an additional 2 percent shall be 40 ...... 6.9 39 ...... 6.8 added to the fluorescence tolerance. 38 ...... 6.8 37 ...... 6.8 PERCENT FOUND FLUORESCENCE TOLERANCE 36 ...... 6.8 35 ...... 6.7 100 ...... 34 ...... 6.7 99 ...... 1.0 33 ...... 6.7 98 ...... 1.6 32 ...... 6.6 97 ...... 2.0 31 ...... 6.6 96 ...... 2.3 30 ...... 6.5 95 ...... 2.6 29 ...... 6.5 94 ...... 2.9 28 ...... 6.4 93 ...... 3.2 27 ...... 6.4 92 ...... 3.4 26 ...... 6.3 91 ...... 3.6 25 ...... 6.2 90 ...... 3.8 24 ...... 6.2 89 ...... 4.0 23 ...... 6.1 88 ...... 4.1 22 ...... 6.0 87 ...... 4.3 21 ...... 5.9 86 ...... 4.5 20 ...... 5.8 85 ...... 4.7 19 ...... 5.7 84 ...... 4.8 18 ...... 5.6 83 ...... 4.9 17 ...... 5.5 82 ...... 5.0 16 ...... 5.4 81 ...... 5.2 15 ...... 5.3 80 ...... 5.3 14 ...... 5.2 79 ...... 5.4 13 ...... 5.0 78 ...... 5.5 12 ...... 4.9
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PERCENT FOUND FLUORESCENCE TOLERANCE— § 201.62 Tests for determination of per- Continued centages of kind, variety, type, hy- brid, or offtype. 11 ...... 4.7 10 ...... 4.6 Tolerances for tests for determina- 9 ...... 4.4 8 ...... 4.2 tion of percentages of kind, variety, 7 ...... 4.0 type, hybrid, or offtype shall be those 6 ...... 3.7 set forth in the following table, added 5 ...... 3.5 4 ...... 3.2 to one-half the required pure seed tol- 3 ...... 2.8 erances determined in accordance with 2 ...... 2.4 § 201.60, except that one-half the pure 1 ...... 1.8 0 ...... 1.0 seed tolerance will not be applied in de- termining tolerances for hybrids la- [32 FR 12781, Sept. 6, 1967, as amended at 59 beled on the basis of the percentage of FR 64516, Dec. 14, 1994] pure seed which is hybrid.
TABLE 4—TOLERANCES FOR PURITY TESTS, WHEN RESULTS ARE BASED ON 10 TO 1,000 SEEDS, SEEDLINGS, OR PLANTS USED IN A TEST
Number of seeds, seedlings, or plants in tests Seed, seedling, or plant count percent 10 20 30 50 75 100 150 200 400 800 1,000
100 or 0 ...... 0 0 0 0 000000 0 98 or 2 ...... 10.3 7.3 6.0 4.6 3.8 3.3 2.7 2.3 1.6 1.2 1.0 96 or 4 ...... 14.4 10.2 8.3 6.4 5.3 4.6 3.7 3.2 2.3 1.7 1.5 94 or 6 ...... 17.5 12.4 10.1 7.8 6.4 5.5 4.5 3.9 2.9 2.1 1.9 92 or 8 ...... 20.0 14.1 11.5 8.9 7.3 6.3 5.2 4.5 3.4 2.4 2.2 90 or 10 ...... 22.1 15.7 12.8 9.9 8.1 7.0 5.7 4.9 3.8 2.8 2.4 88 or 12 ...... 24.0 17.0 13.8 10.7 8.7 7.6 6.2 5.4 4.1 3.0 2.7 86 or 14 ...... 25.7 18.1 14.7 11.4 9.3 8.1 6.6 5.7 4.5 3.2 2.9 84 or 16 ...... 26.9 19.0 15.5 12.1 9.8 8.5 7.0 6.0 4.8 3.4 3.0 82 or 18 ...... 28.2 20.0 16.4 12.6 10.3 8.9 7.3 6.3 5.0 3.6 3.2 80 or 20 ...... 29.5 20.9 16.9 13.2 10.7 9.3 7.6 6.6 5.3 3.8 3.3 78 or 22 ...... 30.5 21.6 17.6 13.6 11.0 9.6 7.9 6.8 5.5 3.9 3.5 76 or 24 ...... 31.4 22.3 18.2 14.1 11.5 9.9 8.1 7.0 5.7 4.1 3.6 74 or 26 ...... 32.3 22.8 18.6 14.4 11.8 10.2 8.3 7.2 5.8 4.2 3.7 72 or 28 ...... 33.0 23.4 19.0 14.8 12.1 10.5 8.5 7.4 6.0 4.3 3.8 70 or 30 ...... 33.7 23.8 19.5 15.1 12.3 10.7 8.7 7.5 6.2 4.4 3.9 68 or 32 ...... 34.3 24.3 19.9 15.4 12.5 10.8 8.9 7.7 6.3 4.5 4.0 66 or 34 ...... 35.0 24.7 20.2 15.7 12.7 11.0 9.0 7.8 6.4 4.6 4.0 64 or 36 ...... 35.4 25.0 20.5 15.8 12.9 11.2 9.1 7.9 6.5 4.6 4.1 62 or 38 ...... 35.5 25.4 20.6 15.9 13.0 11.3 9.2 8.0 6.6 4.7 4.2 60 or 40 ...... 36.1 25.7 20.9 16.1 13.2 11.4 9.3 8.1 6.7 4.8 4.2 58 or 42 ...... 36.2 25.7 21.0 16.2 13.3 11.5 9.4 8.1 6.8 4.8 4.2 56 or 44 ...... 36.5 25.8 21.0 16.4 13.3 11.5 9.4 8.2 6.8 4.8 4.3 54 or 46 ...... 36.8 25.8 21.2 16.4 13.4 11.6 9.5 8.2 6.9 4.9 4.3 52 or 48 ...... 36.8 25.9 21.2 16.5 13.4 11.6 9.5 8.2 6.9 4.9 4.3 50 ...... 36.8 25.9 21.3 16.5 13.4 11.6 9.5 8.2 6.9 4.9 4.3
[32 FR 12781, Sept. 6, 1967, as amended at 33 FR 10841, July 31, 1968; 35 FR 6108, April 15, 1970; 59 FR 64516, Dec. 14, 1994]
§ 201.63 Germination. Mean (See ¤ 201.59) Tolerance The following tolerances are applica- Less than 60 ...... 10 ble to the percentage of germination and also to the sum of the germination When only 200 seeds of a component plus the hard seed when 400 or more in a mixture are tested 2 percent shall seeds are tested. be added to the above germination tol- erances. Mean (See ¤ 201.59) Tolerance [15 FR 2399, Apr. 28, 1950, as amended at 20 96 or over ...... 5 FR 7940, Oct. 21, 1955] 90 or over but less than 96 ...... 6 80 or over but less than 90 ...... 7 70 or over but less than 80 ...... 8 60 or over but less than 70 ...... 9
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§ 201.64 Pure live seed. [5 FR 35, Jan. 4, 1940, as amended at 15 FR 2399, Apr. 28, 1950. Redesignated at 20 FR The tolerance for pure live seed shall 7940, Oct. 21, 1955, as amended at 26 FR 10036, be determined by applying the respec- Oct. 26, 1961; 32 FR 12782, Sept. 6, 1967; 65 FR tive tolerances to the germination plus 1709, Jan. 11, 2000] the hard seed and the pure seed. § 201.66 [Reserved] [5 FR 35, Jan. 4, 1940. Redesignated at 20 FR 7940, Oct. 21, 1955] CERTIFIED SEED
§ 201.65 Noxious weed seeds in inter- § 201.67 Seed certifying agency stand- state commerce. ards and procedures. Tolerances for rates of occurrence of In order to qualify as a seed certi- noxious-weed seeds shall be recognized fying agency for purposes of section and shall be applied to the number of 101(a)(25) of the Federal Seed Act (7 noxious-weed seeds found by analysis U.S.C. 1551(a)(25)) an agency must en- in the quantity of seed specified for force standards and procedures, as con- noxious-weed seed determination in ditions for its certification of seed, § 201.46, except as provided in § 201.16(b). that meet or exceed the standards and Applicable tolerances are calculated by procedures specified in § 201.68 through the formula, Y=X+1+1.96√X, where X is 201.78. the number of seeds represented by the [38 FR 25662, Sept. 14, 1973; 60 FR 57146, Nov. label or test and Y is the maximum 14, 1995] number within tolerance.1 Some toler- ances are listed in the table. The num- § 201.68 Eligibility requirements for ber found as represented by the label or certification of varieties. test (Column X) will be considered The certifying agency shall require within tolerance if not more than the the originator, developer, or owner of corresponding number in Column Y are the variety, or agent thereof, to make found by analysis in the administra- the following available when eligibility tion of the Act. For numbers of seeds for certification is requested: greater than those in the table and in (a) The name of the variety. case of additional or more extensive (b) A statement concerning the analyses, a tolerance based on a degree variety’s origin and the breeding proce- of certainty of 5 percent (P=0.05) will dure used in its development. be recognized. (c) A detailed description of the mor- Number rep- Maximum Maximum phological, physiological, and other resented by number with- Number la- number with- characteristics of the plants and seed the label or in tolerances beled or rep- in tolerances test (X) (Y) resented (X) (Y) that distinguish it from other vari- eties. 0 2 16 24 (d) Evidence supporting the identity 1 4 17 25 of the variety, such as comparative 2 6 18 27 3 8 19 28 yield data, insect and disease resist- 4 9 20 29 ance, or other factors supporting the 5112130identity of the variety. 6122232(e) A statement delineating the geo- 7132333graphic area or areas of adaptation of 8142434the variety. 9162535 10 17 26 37 (f) A statement on the plans and pro- 11 18 27 38 cedures for the maintenance of seed 12 20 28 39 classes, including the number of gen- 13 21 29 41 erations through which the variety 14 22 30 42 may be multiplied. 15 23 (g) A description of the manner in which the variety is constituted when 1 Rates per pound or ounce must be con- a particular cycle of reproduction or verted to the equivalent number of seeds multiplication is specified. found in § 201.46, Table 1, Minimum weight (h) Any additional restrictions on the for noxious-weed seed examination (grams). variety, specified by the breeder, with
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respect to geographic area of seed pro- § 201.72 Production of all classes of duction, age of stand or other factors certified seed. affecting genetic purity. (a) Each certifying agency shall de- (i) A sample of seed representative of termine that genetic purity and iden- the variety as marketed. tity are maintained at all stages of cer- [38 FR 25662, Sept. 14, 1973. 60 FR 57146, Nov. tification including seeding, har- 14, 1995] vesting, processing, and labeling of the seed. § 201.69 Classes of certified seed. (b) The unit of certification shall be a clearly defined field or fields. (a) Classes of certified seed are as fol- (c) One or more field inspections lows: shall be made (1) previous to the time (1) Breeder. a seed crop of any class of certified (2) Foundation. seed is to be harvested, and (2) when (3) Registered. genetic purity and identity can best be (4) Certified. determined. The field shall be in suit- able condition to permit an adequate [38 FR 25662, Sept. 14, 1973] inspection to determine genetic purity § 201.70 Limitations of generations for and identity. certified seed. (d) A certification sample shall be drawn in a manner approved by the The number of generations through certifying agency from each cleaned which a variety may be multiplied lot of seed eligible for certification. shall be limited to that specified by the Evidence that any lot of seed has not originating breeder or owner and shall been protected from contamination not exceed two generations beyond the which might affect genetic purity, or is Foundation seed class with the fol- not properly identified, shall be cause lowing exceptions which may be made for possible rejection of certification. with the permission of the originating [38 FR 25662, Sept. 14, 1973] or sponsoring plant breeder, institu- tion, or his designee: § 201.73 Processors and processing of (a) Recertification of the Certified all classes of certified seed. class may be permitted when no Foun- The following requirements must be dation seed is being maintained. met by processors of all classes of cer- (b) The production of an additional tified seed: generation of the Certified class may (a) Facilities shall be available to be permitted on a 1-year basis only, perform processing without intro- when an emergency is declared by any ducing admixtures. official seed certifying agency stating (b) Identity of the seed must be main- that the Foundation and Registered tained at all times. seed supplies are not adequate to plant (c) Records of all operations relating the needed Certified acreage of the va- to certification shall be complete and riety. The additional generation of Cer- adequate to account for all incoming tified seed to meet the emergency need seed and final disposition of seed. is ineligible for recertification. (d) Processors shall permit inspection by the certifying agency of all records [38 FR 25662, Sept. 14, 1973; 38 FR 26800, Sept. pertaining to all classes of certified 26, 1973, as amended at 46 FR 53639, Oct. 29, seed. 1981] (e) Processors shall designate an indi- vidual who shall be responsible to the § 201.71 Establishing the source of all certifying agency for performing such classes of certified seed. duties as may be required by the certi- The certifying agency shall have evi- fying agency. dence of the class and source of seed (f) Seed lots of the same variety and used to plant each crop being consid- class may be blended and the class re- ered for certification. tained. If lots of different classes are blended, the lowest class shall be ap- [38 FR 25662, Sept. 14, 1973] plied to the resultant blend. Such
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blending can only be done when au- in containers carrying official certifi- thorized by the certifying agency. cation labels, or if shipped for proc- [38 FR 25662, Sept. 14, 1973] essing, evidence of its eligibility from another official certifying agency, to- § 201.74 Labeling of all classes of cer- gether with the following information: tified seed. (1) Variety (if certified as to variety) (a) All classes of certified seed when and kind; offered for sale shall have an official (2) Quantity of seed (pounds or bush- certification label affixed to each con- els); tainer clearly identifying the certi- (3) Class of certified seed; fying agency, the lot number or other (4) Inspection or lot number trace- identification, the variety name (if cer- able to the previous certifying agency’s tified as to variety), and the kind and records. class of seed. Except that for seed mix- (c) Each label used in interagency tures and seed in containers of 5 certification shall be serially numbered pounds or less, the certification labels or carry the certification identity need not bear the name of the kind or kind and variety of each component, number and clearly identify the certi- provided the name of each kind or kind fying agencies involved, the variety (if and variety is shown on the analysis certified as to variety), and the kind label. and class of seed. Except that for seed (b) In the case of seed sold in bulk, mixtures and seed in containers of 5 the invoice or accompanying document pounds or less, the certification labels shall identify the certifying agency, need not bear the name of the kind or the crop kind, variety (if certified as to kind and variety of each component, variety), class of seed, and the lot num- provided the name of each kind or kind ber or other identification. and variety is shown on the analysis (c) The official certification label label. may be printed directly on the con- tainer when an accounting of the con- [38 FR 25662, Sept. 14, 1973; 38 FR 26800, Sept. tainers is required by the certifying 26, 1973, as amended at 65 FR 1710, Jan. 11, 2000] agency. (d) Labels other than those printed § 201.76 Minimum Land, Isolation, on the containers shall be attached to Field, and Seed Standards. containers in a manner that prevents removal and reattachment without In the following Table 5 the figures in tampering being obvious. the ‘‘Land’’ column indicate the num- ber of years that must elapse between [38 FR 25662, Sept. 14, 1973, as amended at 46 the destruction of a stand of a kind and FR 53639, Oct. 29, 1981; 65 FR 1709, Jan. 11, 2000] establishment of a stand of a specified class of a variety of the same kind. A § 201.75 Interagency certification. certification agency may grant a vari- Interagency certification may be ac- ance in the land cropping history in complished by participation of more specific circumstances where cultural than one official certifying agency in practices have been proven adequate to performing the services required to maintain genetic purity. The figures in certify a lot of seed. ‘‘Isolation’’ column indicate the dis- (a) The certifying agency issuing la- tance in feet from any contaminating bels for all classes of certified seed source. The figures in the ‘‘Field’’ col- shall require the seed on which the la- umn indicate the minimum number of bels are used to meet standards at least plants or heads in which one plant or equal to the minimum genetic stand- head of another variety is permitted. ards for the seed in question as speci- The figure in the ‘‘Seed’’ column indi- fied in Table 5 of this part. cate the maximum percentage of seed (b) Seed to be recognized for inter- of other varieties or off-types per- agency certification must be received mitted in the cleaned seed.
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ADDITIONAL REQUIREMENTS FOR THE tral stem or branches, or any combina- CERTIFICATION OF PLANT MATERIALS tion thereof, shedding pollen. OF CERTAIN CROPS (c) Sorghum. Shedders in the seed par- ent, at any one inspection, are limited § 201.77 Length of stand requirements. to 1:3,000 plants for Foundation class (a) Alfalfa. Limitations on the age of and 1:1,500 plants for Certified class. stand and certified seed classes (d) Sunflowers. Seed parents flowering through which a given variety may be and shedding pollen before the male multiplied both inside and outside its parents are shedding pollen must be re- region of adaptation shall be specified moved. At least 50 percent of the male by the originator or his designee. Cer- plants must be producing pollen when tified seed production outside the re- the seed parent is in full bloom. gion of adaptation shall not exceed 6 (e) Hybrid alfalfa. When at least 75 years if not otherwise specified by the percent of the plants are in bloom and originator, or his designee. there is no more than 15 percent seed (b) Red clover. Only two seed crops set, 200 plants shall be examined to de- are permitted of all certified seed termine the pollen production index classes. (PPI). Each plant is rated as 1, 2, 3 or (c) White and alsike clover. Only two 4 with ‘‘1’’ representing no pollen, ‘‘2’’ successive seed crops are permitted fol- representing a trace of pollen, ‘‘3’’ rep- lowing the year of establishment for resenting substantially less than nor- Foundation and Registered classes, but mal pollen, and ‘‘4’’ representing nor- 2 additional years are permitted if the mal pollen. The rating is weighted as 0, field is reclassified to the next lower 0.1, 0.6 or 1.0, respectively. The total class. Four successive seed crops fol- number of plants of each rating is mul- lowing seeding are permitted if the tiplied by the weighted rating and the first and succeeding crops are of the values are totaled. The total is divided Certified class, provided the stand of by the number of plants rated and mul- perennial plants is maintained. tiplied by 100 to determine the PPI. (d) Sainfoin. All certified seed classes The maximum PPI allowed is 14 for the are eligible to produce five successive Foundation class, and 6 for 95 percent seed crops following seeding. hybrid seed, and 42 for 75 percent hy- [38 FR 25664, Sept. 14, 1973] brid seed of the Certified class.
§ 201.78 Pollen control for hybrids. [38 FR 25664, Sept. 14, 1973, as amended at 41 FR 20158, May 17, 1976] (a) Wheat and barley. Shedders in the seed parent, at any one inspection, are limited to 1:200 heads for Foundation A PART 202—FEDERAL SEED ACT Line and 1:100 heads for Registered A RULES OF PRACTICE Line, except that when the A Line is increased outside the area of the an- Subpart A—General ticipated A x R production in order to Sec. utilize self-fertility produced by envi- 202.1 Meaning of words. ronmental effects, only isolation and 202.2 Definitions. genetic purity standards will be in ef- 202.3 Institution of proceedings. fect. (An A Line is a cytoplasmic male 202.4 Status of applicant. sterile female line used to produce hy- brid seed. An R Line is a pollinator line Subpart B [Reserved] used to pollinate an A Line and to re- store fertility in the resulting hybrid Subpart C—Rules Applicable to Other seed.) Proceedings (b) Corn. When 5 percent or more of the seed parent plants have receptive 202.40 Proceedings prior to reporting for silks, shedding tassels in the seed par- criminal prosecution. 202.41 Notice and hearing prior to promul- ent plants shall be limited to 1 percent gation of rules and regulations. at any one inspection, or a total of 2 202.42 Publication of judgments, settle- percent at any three inspections on dif- ments, and orders. ferent dates. Shedding tassels are those 202.43 Proceedings under section 302(a) to which have 2 inches or more of the cen- show cause why seed or screenings
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should be admitted into the United sons or basis for conclusions and (2) States. order. 202.44 Proceedings under section 305(b) to (h) The term hearing means that part determine whether foreign alfalfa or red of a proceeding which involves the sub- clover seed is not adapted for general ag- ricultural use in the United States. mission of evidence and means either an oral or written hearing. AUTHORITY: Secs. 302, 305, 402, 408, 409, 413, (i) Hearing Clerk means the Hearing 414, 53 Stat. 1275, as amended; 7 U.S.C. 1582, Clerk, U.S. Department of Agriculture, 1585, 1592, 1598, 1599, 1603, 1604. Washington, DC 20250. SOURCE: 36 FR 1314, Jan. 27, 1971, unless (j) The term person includes any indi- otherwise noted. vidual, partnership, corporation, com- pany, society, association, receiver, or Subpart A—General trustee. (k) The term regulations means the § 202.1 Meaning of words. regulations promulgated pursuant to As used in this part, words in the sin- the Act (7 CFR part 201). gular form shall be deemed to import (l) Respondent means the party pro- the plural, and vice versa, as the case ceeded against. may require. (m) Secretary means the Secretary of Agriculture of the United States, or § 202.2 Definitions. any officer or employee of the U.S. De- For the purposes of this part, the fol- partment of Agriculture to whom au- lowing terms shall be construed, re- thority has heretofore been delegated, spectively, to mean: or to whom authority may hereafter be (a) The term Act means the Federal delegated, to act in his stead, including Seed Act, approved August 9, 1939 (53 the Judicial Officer. Stat. 1275, 7 U.S.C. 1551 et seq.) and any legislation amendatory thereof. § 202.3 Institution of proceedings. (b) Complaint means any formal com- Any person having information of plaint and notice of hearing or other any violation of the Act or of any of document by virtue of which a pro- the regulations promulgated there- ceeding under the Act is instituted. under may file with the Director an ap- (c) Complainant means the party upon plication requesting the institution of whose complaint the proceeding is in- such proceedings as may be authorized stituted. under the Act. Such application shall (d) Decision and Order includes the be in writing, signed by or on behalf of Secretary’s findings, conclusions, the applicant, and shall contain a short order, and rulings on motions, excep- and simple statement of the facts con- tions, statements of objections, and stituting the alleged violation and the proposed findings, conclusions and or- name and address of the applicant and ders submitted by the parties not the party complained of. If, after inves- theretofore ruled upon. tigation of the matters complained of (e) Director means the Director of the in the application or after investiga- Grain Division, Agricultural Marketing tion made on his own motion, the Di- Service, U.S. Department of Agri- rector has reason to believe that any culture, or any officer or employee of person has violated or is violating any the Department to whom authority is of the provisions of the Act or the reg- delegated to act in his stead. ulations made and promulgated there- (f) Administrative Law Judge means an under, he may institute such pro- Administrative Law Judge in the Office ceedings as may be authorized by the of Administrative Law Judge, U.S. De- Act. partment of Agriculture. (g) Administrative Law Judge Rec- § 202.4 Status of applicant. ommended Decision means the Adminis- The person filing an application shall trative Law Judge’s report to the Sec- not be a party to any proceeding which retary consisting of the proposed: (1) may be instituted under the Act, un- Findings of facts and conclusions with less he be permitted by the Secretary respect to all material issues of fact, or by the Administrative Law Judge to law or discretion, as well as the rea- intervene therein. The Director shall
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not be required to divulge the name of mulgate such rule or regulation and of the applicant and such person will have the time and place of a public hearing no legal status in the proceeding which to be held with reference thereto. Such may be instituted, except where al- hearings shall be conducted by the Di- lowed to intervene or as such person rector or by such employee or employ- may be called as a witness. At any ees of the Department of Agriculture time after the institution of the pro- as may be designated to preside ceeding, and before it has been sub- thereat, except that hearings with re- mitted to the Secretary for final con- spect to rules or regulations con- sideration, the Secretary or the Ad- templated by section 402(b) of the Act ministrator, may upon petition in writ- relating to title III of the Act (Foreign ing and upon good cause shown, permit Commerce), shall be conducted by the any person to intervene. Secretary of the Treasury and the Sec- retary of Agriculture, acting jointly or Subpart B [Reserved] separately, or by such employee or em- ployees of the Department of Agri- Subpart C—Rules Applicable to culture or the Department of the Other Proceedings Treasury as may be designated to pre- side thereat. The presiding officer shall § 202.40 Proceedings prior to reporting conduct the hearing in an orderly and for criminal prosecution. informal manner, according to such The Director shall, before any viola- procedure as he may announce at the tion of this act is reported to any U.S. commencement of the hearing. Any attorney for institution of a criminal rule or regulation promulgated under proceeding, notify the person against section 402 of the Act shall become ef- whom such proceeding is contemplated fective on the date fixed in the promul- that action is contemplated, inform gation, which date shall be not less him regarding the facts involved, and than 30 days after publication in the afford him an opportunity to present FEDERAL REGISTER. Any rule or regula- his views, either orally or in writing, tion may be amended or revoked in the with regard to such contemplated pro- same manner as is provided for its pro- ceeding. Notice shall be served upon mulgation. such person in the manner provided in § 202.27 of this part. If the person de- § 202.42 Publication of judgments, set- sires to explain the transaction or oth- tlements, and orders. erwise to present his views, he shall After judgment or settlement, or the file with the Director, within 20 days issuance of a cease and desist order, in after the service of the notice, an an- any case or proceeding arising under swer, in duplicate, signed by him or by this Act, notice thereof containing any his attorney, or shall request, within information pertinent to the judgment the 20 days, an opportunity to express or settlement or the issuance of the his views orally. The request shall be cease and desist order, shall be given embodied in a writing signed by the by issuing a press release or by such person or by his attorney or agent. other media as the Administrator of Such opportunity to present his views the Agricultural Marketing Service orally shall be afforded at a time and may designate from time to time. place to be designated by the Director and it shall be given within a time not § 202.43 Proceedings under section to exceed 10 days after the date of the 302(a) to show cause why seed or filing of the request therefor. screenings should be admitted into the United States. § 202.41 Notice and hearing prior to When seed or screenings have been promulgation of rules and regula- refused admission into the United tions. States under the Act or the joint regu- Prior to the promulgation of any rule lations promulgated thereunder, the or regulation contemplated by section owner or consignee of such seed or 402 of the Act (7 U.S.C. 1592), notice screenings may submit a request to the shall be given by publication in the Director for a hearing in which he may FEDERAL REGISTER of intention to pro- show cause, if any he have, why such
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seed or screenings should be admitted. § 202.44 Proceedings under section Request for such hearing shall be em- 305(b) to determine whether foreign bodied in a writing signed by the owner alfalfa or red clover seed is not or consignee or by his attorney or adapted for general agricultural use in the United States. agent. The Director shall thereupon fix, and notify the owner or consignee The public hearings which shall be of, the time when and place at which held from time to time for the purpose the hearing will be held. The hearing of determining whether seed of alfalfa shall be conducted in an orderly and in- or red clover from any foreign country formal manner by the Director or by a or region is not adapted for general ag- presiding officer duly designated by ricultural use in the United States shall be conducted by the Director, or him, and it shall be governed by such by a presiding officer duly designated rules of procedure as the presiding offi- by him. Such hearings shall be con- cer shall announce at the opening of ducted in an orderly and informal man- the hearing. The determination as to ner in accordance with such procedure whether the seed or screenings may be as the presiding officer shall announce admitted into the United States shall at the opening of each hearing. The Ad- be made by the Administrator of the ministrator of the Agricultural Mar- Agricultural Marketing Service, within keting Service shall, within a reason- a reasonable time after the close of the able time after the close of the public hearing, and the owner or consignee of hearing, make and publish his deter- the seed or screenings who requested mination as to whether the said seed is the hearing and the Secretary of the adapted for general agricultural use in Treasury shall be duly notified as to the United States. Publication of the such determination. determination shall be made in the FEDERAL REGISTER, and through such other media as the said Administrator may deem appropriate.
PARTS 203–204 [RESERVED]
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PART 205—NATIONAL ORGANIC Subpart D—Labels, Labeling, and Market PROGRAM Information 205.300 Use of the term, ‘‘organic.’’ Subpart A—Definitions 205.301 Product composition. 205.302 Calculating the percentage of or- Sec. ganically produced ingredients. 205.1 Meaning of words. 205.303 Packaged products labeled ‘‘100 per- 205.2 Terms defined. cent organic’’ or ‘‘organic.’’ 205.304 Packaged products labeled ‘‘made Subpart B—Applicability with organic (specified ingredients or food group(s)).’’ 205.100 What has to be certified. 205.305 Multiingredient packaged products 205.101 Exemptions and exclusions from cer- with less that 70 percent organically pro- tification. duced ingredients. 205.102 Use of the term, ‘‘organic.’’ 205.306 Labeling of livestock feed. 205.103 Recordkeeping by certified oper- 205.307 Labeling of nonretail containers ations. used for only shipping or storage of raw or processed agricultural products la- 205.104 [Reserved] beled as ‘‘100 percent organic,’’ ‘‘or- 205.105 Allowed and prohibited substances, ganic,’’ or ‘‘made with organic (specified methods, and ingredients in organic pro- ingredients or food group(s)).’’ duction and handling. 205.308 Agricultural products in other than 205.106–205.199 [Reserved] packaged form at the point of retail sale that are sold, labeled, or represented as Subpart C—Organic Production and ‘‘100 percent organic’’ or ‘‘organic.’’ Handling Requirements 205.309 Agricultural products in other than packaged form at the point of retail sale 205.200 General. that are sold, labeled, or represented as 205.201 Organic production and handling ‘‘made with organic (specified ingredi- system plan. ents or food group(s)).’’ 205.202 Land requirements. 205.310 Agricultural products produced on 205.203 Soil fertility and crop nutrient man- an exempt or excluded operation. agement practice standard. 205.311 USDA Seal. 205.204 Seeds and planting stock practice 205.312–205.399 [Reserved] standard. 205.205 Crop rotation practice standard. Subpart E—Certification 205.206 Crop pest, weed, and disease manage- 205.400 General requirements for certifi- ment practice standard. cation. 205.207 Wild-crop harvesting practice stand- 205.401 Application for certification. ard. 205.402 Review of application. 205.208–205.235 [Reserved] 205.403 On-site inspections. 205.236 Origin of livestock. 205.404 Granting certification. 205.237 Livestock feed. 205.405 Denial of certification. 205.238 Livestock health care practice 205.406 Continuation of certification. standard. 205.407–205.499 [Reserved] 205.239 Livestock living conditions. 205.240–205.269 [Reserved] Subpart F—Accreditation of Certifying 205.270 Organic handling requirements. Agents 205.271 Facility pest management practice 205.500 Areas and duration of accreditation. standard. 205.501 General requirements for accredita- 205.272 Commingling and contact with pro- tion. hibited substance prevention practice 205.502 Applying for accreditation. standard. 205.503 Applicant information. 205.273–205.289 [Reserved] 205.504 Evidence of expertise and ability. 205.290 Temporary variances. 205.505 Statement of agreement. 205.291–205.299 [Reserved] 205.506 Granting accreditation.
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205.507 Denial of accreditation. 205.699 [Reserved] 205.508 Site evaluations. 205.509 Peer review panel. INSPECTION AND TESTING, REPORTING, AND 205.510 Annual report, recordkeeping, and EXCLUSION FROM SALE renewal of accreditation. 205.670 Inspection and testing of agricul- 205.511–205.599 [Reserved] tural product to be sold or labeled ‘‘or- ganic.’’ Subpart G—Administrative 205.671 Exclusion from organic sale. 205.672 Emergency pest or disease treat- THE NATIONAL LIST OF ALLOWED AND ment. PROHIBITED SUBSTANCES 205.673–205.679 [Reserved] 205.600 Evaluation criteria for allowed and prohibited substances, methods, and in- ADVERSE ACTION APPEAL PROCESS gredients. 205.680 General. 205.601 Synthetic substances allowed for use 205.681 Appeals. in organic crop production. 205.682–205.689 [Reserved] 205.602 Nonsynthetic substances prohibited for use in organic crop production. MISCELLANEOUS 205.603 Synthetic substances allowed for use 205.690 OMB control number. in organic livestock production. 205.691–205.699 [Reserved] 205.604 Nonsynthetic substances prohibited for use in organic livestock production. AUTHORITY: 7 U.S.C. 6501–6522. 205.605 Nonagricultural (nonorganic) sub- SOURCE: 65 FR 80637, Dec. 21, 2000, unless stances allowed as ingredients in or on otherwise noted. processed products labeled as ‘‘organic,’’ or ‘‘made with organic (specified ingredi- EFFECTIVE DATE NOTE: At 65 FR 80637, Dec. ents or food group(s)).’’ 21, 2000, subchapter M consisting of parts 205 205.606 Nonorganically produced agricul- through 209 was added, effective Feb. 20, 2001. tural products allowed as ingredients in or on processed products labeled as ‘‘or- Subpart A—Definitions ganic’’ or ‘‘made with organic (specified ingredients or food group(s)).’’ § 205.1 Meaning of words. 205.607 Amending the National List. 205.608–205.619 [Reserved] For the purpose of the regulations in this subpart, words in the singular STATE ORGANIC PROGRAMS form shall be deemed to impart the 205.620 Requirements of State organic pro- plural and vice versa, as the case may grams. demand. 205.621 Submission and determination of proposed State organic programs and § 205.2 Terms defined. amendments to approved State organic programs. Accreditation. A determination made 205.622 Review of approved State organic by the Secretary that authorizes a pri- programs. vate, foreign, or State entity to con- 205.623–205.639 [Reserved] duct certification activities as a certi- fying agent under this part. FEES Act. The Organic Foods Production 205.640 Fees and other charges for accredita- Act of 1990, as amended (7 U.S.C. 6501 et tion. seq.). 205.641 Payment of fees and other charges. Action level. The limit at or above 205.642 Fees and other charges for certifi- which the Food and Drug Administra- cation. 205.643–205.649 [Reserved] tion will take legal action against a product to remove it from the market. COMPLIANCE Action levels are based on 205.660 General. unavoidability of the poisonous or del- 205.661 Investigation of certified operations. eterious substances and do not rep- 205.662 Noncompliance procedure for cer- resent permissible levels of contamina- tified operations. tion where it is avoidable. 205.663 Mediation. Administrator. The Administrator for 205.664 [Reserved] the Agricultural Marketing Service, 205.665 Noncompliance procedure for certi- fying agents. United States Departure of Agri- 205.666–205.667 [Reserved] culture, or the representative to whom 205.668 Noncompliance procedures under authority has been delegated to act in State Organic Programs. the stead of the Administrator.
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Agricultural inputs. All substances or the diagnosis, treatment, or prevention materials used in the production or of diseases of animals. handling of organic agricultural prod- Breeder stock. Female livestock whose ucts. offspring may be incorporated into an Agricultural product. Any agricultural organic operation at the time of their commodity or product, whether raw or birth. processed, including any commodity or Buffer zone. An area located between product derived from livestock, that is a certified production operation or por- marketed in the United States for tion of a production operation and an human or livestock consumption. adjacent land area that is not main- Agricultural Marketing Service (AMS). tained under organic management. A The Agricultural Marketing Service of buffer zone must be sufficient in size or the United States Department of Agri- other features (e.g., windbreaks or a di- culture. version ditch) to prevent the possi- Allowed synthetic. A substance that is bility of unintended contact by prohib- included on the National List of syn- ited substances applied to adjacent thetic substances allowed for use in or- land areas with an area that is part of ganic production or handling. a certified operation. Bulk. The presentation to consumers Animal drug. Any drug as defined in at retail sale of an agricultural product section 201 of the Federal Food, Drug, in unpackaged, loose form, enabling and Cosmetic Act, as amended (21 the consumer to determine the indi- U.S.C. 321), that is intended for use in vidual pieces, amount, or volume of the livestock, including any drug intended product purchased. for use in livestock feed but not includ- Certification or certified. A determina- ing such livestock feed. tion made by a certifying agent that a Annual seedling. A plant grown from production or handling operation is in seed that will complete its life cycle or compliance with the Act and the regu- produce a harvestable yield within the lations in this part, which is docu- same crop year or season in which it mented by a certificate of organic op- was planted. eration. Area of operation. The types of oper- Certified operation. A crop or live- ations: crops, livestock, wild-crop har- stock production, wild-crop harvesting vesting or handling, or any combina- or handling operation, or portion of tion thereof that a certifying agent such operation that is certified by an may be accredited to certify under this accredited certifying agent as utilizing part. a system of organic production or han- Audit trail. Documentation that is dling as described by the Act and the sufficient to determine the source, regulations in this part. transfer of ownership, and transpor- Certifying agent. Any entity accred- tation of any agricultural product la- ited by the Secretary as a certifying beled as ‘‘100 percent organic,’’ the or- agent for the purpose of certifying a ganic ingredients of any agricultural production or handling operation as a product labeled as ‘‘organic’’ or ‘‘made certified production or handling oper- with organic (specified ingredients)’’ or ation. the organic ingredients of any agricul- Certifying agent’s operation. All sites, tural product containing less than 70 facilities, personnel, and records used percent organic ingredients identified by a certifying agent to conduct cer- as organic in an ingredients statement. tification activities under the Act and Biodegradable. Subject to biological the regulations in this part. decomposition into simpler bio- Claims. Oral, written, implied, or chemical or chemical components. symbolic representations, statements, Biologics. All viruses, serums, toxins, or advertising or other forms of com- and analogous products of natural or munication presented to the public or synthetic origin, such as diagnostics, buyers of agricultural products that re- antitoxins, vaccines, live microorga- late to the organic certification proc- nisms, killed microorganisms, and the ess or the term, ‘‘100 percent organic,’’ antigenic or immunizing components ‘‘organic,’’ or ‘‘made with organic of microorganisms intended for use in (specified ingredients or food
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group(s)),’’ or, in the case of agricul- Crop year. That normal growing sea- tural products containing less than 70 son for a crop as determined by the percent organic ingredients, the term, Secretary. ‘‘organic,’’ on the ingredients panel. Cultivation. Digging up or cutting the Commercially available. The ability to soil to prepare a seed bed; control obtain a production input in an appro- weeds; aerate the soil; or work organic priate form, quality, or quantity to ful- matter, crop residues, or fertilizers fill an essential function in a system of into the soil. organic production or handling, as de- Cultural methods. Methods used to en- termined by the certifying agent in the hance crop health and prevent weed, course of reviewing the organic plan. pest, or disease problems without the Commingling. Physical contact be- use of substances; examples include the tween unpackaged organically pro- selection of appropriate varieties and duced and nonorganically produced ag- planting sites; proper timing and den- ricultural products during production, sity of plantings; irrigation; and ex- processing, transportation, storage or tending a growing season by manipu- handling, other than during the manu- lating the microclimate with green facture of a multiingredient product houses, cold frames, or wind breaks. containing both types of ingredients. Detectable residue. The amount or The product of a managed Compost. presence of chemical residue or sample process through which microorganisms component that can be reliably ob- break down plant and animal materials served or found in the sample matrix into more available forms suitable for by current approved analytical meth- application to the soil. Compost must odology. be produced through a process that combines plant and animal materials Disease vectors. Plants or animals with an initial C:N ratio of between that harbor or transmit disease orga- 25:1 and 40:1. Producers using an in-ves- nisms or pathogens which may attack sel or static aerated pile system must crops or livestock. maintain the composting materials at Drift. The physical movement of pro- a temperature between 131 °F and 170 hibited substances from the intended °F for 3 days. Producers using a wind- target site onto an organic operation row system must maintain the or portion thereof. composting materials at a temperature Emergency pest or disease treatment between 131 °F and 170 °F for 15 days, program. A mandatory program author- during which time, the materials must ized by a Federal, State, or local agen- be turned a minimum of five times. cy for the purpose of controlling or Control. Any method that reduces or eradicating a pest or disease. limits damage by populations of pests, Employee. Any person providing paid weeds, or diseases to levels that do not or volunteer services for a certifying significantly reduce productivity. agent. Crop. A plant or part of a plant in- Excluded methods. A variety of meth- tended to be marketed as an agricul- ods used to genetically modify orga- tural product or fed to livestock. nisms or influence their growth and de- Crop residues. The plant parts remain- velopment by means that are not pos- ing in a field after the harvest of a sible under natural conditions or proc- crop, which include stalks, stems, esses and are not considered compat- leaves, roots, and weeds. ible with organic production. Such Crop rotation. The practice of alter- methods include cell fusion, micro- nating the annual crops grown on a encapsulation and macroencapsulation, specific field in a planned pattern or and recombinant DNA technology (in- sequence in successive crop years so cluding gene deletion, gene doubling, that crops of the same species or fam- introducing a foreign gene, and chang- ily are not grown repeatedly without ing the positions of genes when interruption on the same field. Peren- achieved by recombinant DNA tech- nial cropping systems employ means nology). Such methods do not include such as alley cropping, intercropping, the use of traditional breeding, con- and hedgerows to introduce biological jugation, fermentation, hybridization, diversity in lieu of crop rotation. in vitro fertilization, or tissue culture.
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Feed. Edible materials which are con- retailers of agricultural products that sumed by livestock for their nutri- do not process agricultural products) tional value. Feed may be concentrates that receives or otherwise acquires ag- (grains) or roughages (hay, silage, fod- ricultural products and processes, der). The term, ‘‘feed,’’ encompasses all packages, or stores such products. agricultural commodities, including Immediate family. The spouse, minor pasture ingested by livestock for nutri- children, or blood relatives who reside tional purposes. in the immediate household of a certi- Feed additive. A substance added to fying agent or an employee, inspector, feed in micro quantities to fulfill a spe- contractor, or other personnel of the cific nutritional need; i.e., essential certifying agent. For the purpose of nutrients in the form of amino acids, this part, the interest of a spouse, vitamins, and minerals. minor child, or blood relative who is a Feed supplement. A combination of resident of the immediate household of feed nutrients added to livestock feed a certifying agent or an employee, in- to improve the nutrient balance or per- spector, contractor, or other personnel formance of the total ration and in- of the certifying agent shall be consid- tended to be: ered to be an interest of the certifying (1) Diluted with other feeds when fed agent or an employee, inspector, con- to livestock; tractor, or other personnel of the certi- (2) Offered free choice with other fying agent. parts of the ration if separately avail- Inert ingredient. Any substance (or able; or group of substances with similar chem- (3) Further diluted and mixed to ical structures if designated by the En- produce a complete feed. vironmental Protection Agency) other Fertilizer. A single or blended sub- than an active ingredient which is in- stance containing one or more recog- tentionally included in any pesticide nized plant nutrient(s) which is used product (40 CFR 152.3(m)). primarily for its plant nutrient content Information panel. That part of the and which is designed for use or claimed to have value in promoting label of a packaged product that is im- plant growth. mediately contiguous to and to the Field. An area of land identified as a right of the principal display panel as discrete unit within a production oper- observed by an individual facing the ation. principal display panel, unless another Forage. Vegetative material in a section of the label is designated as the fresh, dried, or ensiled state (pasture, information panel because of package hay, or silage), which is fed to live- size or other package attributes (e.g., stock. irregular shape with one usable sur- Governmental entity. Any domestic face). government, tribal government, or for- Ingredient. Any substance used in the eign governmental subdivision pro- preparation of an agricultural product viding certification services. that is still present in the final com- Handle. To sell, process, or package mercial product as consumed. agricultural products, except such Ingredients statement. The list of in- term shall not include the sale, trans- gredients contained in a product shown portation, or delivery of crops or live- in their common and usual names in stock by the producer thereof to a han- the descending order of predominance. dler. Inspection. The act of examining and Handler. Any person engaged in the evaluating the production or handling business of handling agricultural prod- operation of an applicant for certifi- ucts, including producers who handle cation or certified operation to deter- crops or livestock of their own produc- mine compliance with the Act and the tion, except such term shall not in- regulations in this part. clude final retailers of agricultural Inspector. Any person retained or products that do not process agricul- used by a certifying agent to conduct tural products. inspections of certification applicants Handling operation. Any operation or or certified production or handling op- portion of an operation (except final erations.
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Label. A display of written, printed, National Organic Program (NOP). The or graphic material on the immediate program authorized by the Act for the container of an agricultural product or purpose of implementing its provisions. any such material affixed to any agri- National Organic Standards Board cultural product or affixed to a bulk (NOSB). A board established by the container containing an agricultural Secretary under 7 U.S.C. 6518 to assist product, except for package liners or a in the development of standards for display of written, printed, or graphic substances to be used in organic pro- material which contains only informa- duction and to advise the Secretary on tion about the weight of the product. any other aspects of the implementa- Labeling. All written, printed, or tion of the National Organic Program. graphic material accompanying an ag- ricultural product at any time or writ- Natural resources of the operation. The ten, printed, or graphic material about physical, hydrological, and biological the agricultural product displayed at features of a production operation, in- retail stores about the product. cluding soil, water, wetlands, wood- Livestock. Any cattle, sheep, goat, lands, and wildlife. swine, poultry, or equine animals used Nonagricultural substance. A sub- for food or in the production of food, stance that is not a product of agri- fiber, feed, or other agricultural-based culture, such as a mineral or a bac- consumer products; wild or domes- terial culture, that is used as an ingre- ticated game; or other nonplant life, dient in an agricultural product. For except such term shall not include the purposes of this part, a non- aquatic animals or bees for the produc- agricultural ingredient also includes tion of food, fiber, feed, or other agri- any substance, such as gums, citric cultural-based consumer products. acid, or pectin, that is extracted from, Lot. Any number of containers which isolated from, or a fraction of an agri- contain an agricultural product of the cultural product so that the identity of same kind located in the same convey- the agricultural product is unrecogniz- ance, warehouse, or packing house and able in the extract, isolate, or fraction. which are available for inspection at Nonsynthetic (natural). A substance the same time. Manure. Feces, urine, other excre- that is derived from mineral, plant, or ment, and bedding produced by live- animal matter and does not undergo a stock that has not been composted. synthetic process as defined in section Market information. Any written, 6502(21) of the Act (7 U.S.C. 6502(21)). printed, audiovisual, or graphic infor- For the purposes of this part, nonsyn- mation, including advertising, pam- thetic is used as a synonym for natural phlets, flyers, catalogues, posters, and as the term is used in the Act. signs, distributed, broadcast, or made Nonretail container. Any container available outside of retail outlets that used for shipping or storage of an agri- are used to assist in the sale or pro- cultural product that is not used in the motion of a product. retail display or sale of the product. Mulch. Any nonsynthetic material, Nontoxic. Not known to cause any ad- such as wood chips, leaves, or straw, or verse physiological effects in animals, any synthetic material included on the plants, humans, or the environment. National List for such use, such as Organic. A labeling term that refers newspaper or plastic that serves to sup- to an agricultural product produced in press weed growth, moderate soil tem- accordance with the Act and the regu- perature, or conserve soil moisture. lations in this part. Narrow range oils. Petroleum deriva- tives, predominately of paraffinic and Organic matter. The remains, resi- napthenic fractions with 50 percent dues, or waste products of any orga- boiling point (10 mm Hg) between 415 nism. °F and 440 °F. Organic production. A production sys- National List. A list of allowed and tem that is managed in accordance prohibited substances as provided for with the Act and regulations in this in the Act.
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part to respond to site-specific condi- played, presented, shown, or examined tions by integrating cultural, biologi- under customary conditions of display cal, and mechanical practices that fos- for sale. ter cycling of resources, promote eco- Private entity. Any domestic or for- logical balance, and conserve biodiver- eign nongovernmental for-profit or sity. not-for-profit organization providing Organic system plan. A plan of man- certification services. agement of an organic production or Processing. Cooking, baking, curing, handling operation that has been heating, drying, mixing, grinding, agreed to by the producer or handler churning, separating, extracting, and the certifying agent and that in- slaughtering, cutting, fermenting, dis- cludes written plans concerning all as- tilling, eviscerating, preserving, dehy- pects of agricultural production or drating, freezing, chilling, or otherwise handling described in the Act and the manufacturing and includes the pack- regulations in subpart C of this part. aging, canning, jarring, or otherwise Pasture. Land used for livestock graz- enclosing food in a container. ing that is managed to provide feed Processing aid. (1) Substance that is value and maintain or improve soil, added to a food during the processing water, and vegetative resources. of such food but is removed in some Peer review panel. A panel of individ- manner from the food before it is pack- uals who have expertise in organic pro- aged in its finished form; duction and handling methods and cer- (2) a substance that is added to a food tification procedures and who are ap- during processing, is converted into pointed by the Administrator to assist constituents normally present in the in evaluating applicants for accredita- food, and does not significantly in- tion as certifying agents. crease the amount of the constituents Person. An individual, partnership, naturally found in the food; and corporation, association, cooperative, (3) a substance that is added to a food or other entity. for its technical or functional effect in Pesticide. Any substance which alone, the processing but is present in the fin- in chemical combination, or in any for- ished food at insignificant levels and mulation with one or more substances does not have any technical or func- is defined as a pesticide in section 2(u) tional effect in that food. of the Federal Insecticide, Fungicide, Producer. A person who engages in and Rodenticide Act (7 U.S.C. 136(u) et the business of growing or producing seq). food, fiber, feed, and other agricul- Petition. A request to amend the Na- tural-based consumer products. tional List that is submitted by any Production lot number/identifier. Iden- person in accordance with this part. tification of a product based on the Planting stock. Any plant or plant tis- production sequence of the product sue other than annual seedlings but in- showing the date, time, and place of cluding rhizomes, shoots, leaf or stem production used for quality control cuttings, roots, or tubers, used in plant purposes. production or propagation. Prohibited substance. A substance the Practice standard. The guidelines and use of which in any aspect of organic requirements through which a produc- production or handling is prohibited or tion or handling operation implements not provided for in the Act or the regu- a required component of its production lations of this part. or handling organic system plan. A Records. Any information in written, practice standard includes a series of visual, or electronic form that docu- allowed and prohibited actions, mate- ments the activities undertaken by a rials, and conditions to establish a producer, handler, or certifying agent minimum level performance for plan- to comply with the Act and regulations ning, conducting, and maintaining a in this part. function, such as livestock health care Residue testing. An official or vali- or facility pest management, essential dated analytical procedure that de- to an organic operation. tects, identifies, and measures the Principal display panel. That part of a presence of chemical substances, their label that is most likely to be dis- metabolites, or degradations products
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in or on raw or processed agricultural State organic program (SOP). A State products. program that meets the requirements Responsibly connected. Any person of section 6506 of the Act, is approved who is a partner, officer, director, hold- by the Secretary, and is designed to en- er, manager, or owner of 10 percent or sure that a product that is sold or la- more of the voting stock of an appli- beled as organically produced under cant or a recipient of certification or the Act is produced and handled using accreditation. organic methods. Retail food establishment. A res- State organic program’s governing State taurant; delicatessen; bakery; grocery official. The chief executive official of a store; or any retail outlet with an in- State or, in the case of a State that store restaurant, delicatessen, bakery, provides for the statewide election of salad bar, or other eat-in or carry-out an official to be responsible solely for service of processed or prepared raw the administration of the agricultural and ready-to-eat-food. operations of the State, such official Routine use of parasiticide. The reg- who administers a State organic cer- ular, planned, or periodic use of tification program. parasiticides. Synthetic. A substance that is formu- Secretary. The Secretary of Agri- lated or manufactured by a chemical culture or a representative to whom process or by a process that chemically authority has been delegated to act in changes a substance extracted from the Secretary’s stead. naturally occurring plant, animal, or Sewage sludge. A solid, semisolid, or mineral sources, except that such term liquid residue generated during the shall not apply to substances created treatment of domestic sewage in a by naturally occurring biological proc- treatment works. Sewage sludge in- esses. cludes but is not limited to: domestic Tolerance. The maximum legal level septage; scum or solids removed in pri- of a pesticide chemical residue in or on mary, secondary, or advanced waste- a raw or processed agricultural com- water treatment processes; and a mate- modity or processed food. rial derived from sewage sludge. Sew- Transplant. A seedling which has been age sludge does not include ash gen- removed from its original place of pro- erated during the firing of sewage duction, transported, and replanted. sludge in a sewage sludge incinerator Unavoidable residual environmental or grit and screenings generated during contamination (UREC). Background lev- preliminary treatment of domestic els of naturally occurring or synthetic sewage in a treatment works. chemicals that are present in the soil Slaughter stock. Any animal that is or present in organically produced ag- intended to be slaughtered for con- ricultural products that are below es- sumption by humans or other animals. tablished tolerances. Soil and water quality. Observable in- Wild crop. Any plant or portion of a dicators of the physical, chemical, or plant that is collected or harvested biological condition of soil and water, from a site that is not maintained including the presence of environ- under cultivation or other agricultural mental contaminants. management. Split operation. An operation that pro- duces or handles both organic and non- Subpart B—Applicability organic agricultural products. State. Any of the several States of the § 205.100 What has to be certified. United States of America, its terri- (a) Except for operations exempt or tories, the District of Columbia, and excluded in § 205.101, each production or the Commonwealth of Puerto Rico. handling operation or specified portion State certifying agent. A certifying of a production or handling operation agent accredited by the Secretary that produces or handles crops, live- under the National Organic Program stock, livestock products, or other ag- and operated by the State for the pur- ricultural products that are intended poses of certifying organic production to be sold, labeled, or represented as and handling operations in the State. ‘‘100 percent organic,’’ ‘‘organic,’’ or
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‘‘made with organic (specified ingredi- (3) A handling operation or portion of ents or food group(s))’’ must be cer- a handling operation that only handles tified according to the provisions of agricultural products that contain less subpart E of this part and must meet than 70 percent organic ingredients by all other applicable requirements of total weight of the finished product this part. (excluding water and salt) is exempt (b) Any production or handling oper- from the requirements in this part, ex- ation or specified portion of a produc- cept: tion or handling operation that has (i) The provisions for prevention of been already certified by a certifying contact of organic products with pro- agent on the date that the certifying hibited substances set forth in § 205.272 agent receives its accreditation under with respect to any organically pro- this part shall be deemed to be cer- duced ingredients used in an agricul- tified under the Act until the oper- tural product; ation’s next anniversary date of certifi- (ii) The labeling provisions of cation. Such recognition shall only be §§ 205.305 and 205.310; and available to those operations certified (iii) The recordkeeping provisions in by a certifying agent that receives its paragraph (c) of this section. accreditation within 18 months from (4) A handling operation or portion of February 20, 2001. a handling operation that only identi- (c) Any operation that: fies organic ingredients on the infor- (1) Knowingly sells or labels a prod- mation panel is exempt from the re- uct as organic, except in accordance quirements in this part, except: with the Act, shall be subject to a civil (i) The provisions for prevention of penalty of not more than $10,000 per contact of organic products with pro- violation. hibited substances set forth in § 205.272 (2) Makes a false statement under the with respect to any organically pro- Act to the Secretary, a governing duced ingredients used in an agricul- State official, or an accredited certi- tural product; fying agent shall be subject to the pro- (ii) The labeling provisions of visions of section 1001 of title 18, §§ 205.305 and 205.310; and United States Code. (iii) The recordkeeping provisions in paragraph (c) of this section. § 205.101 Exemptions and exclusions (b) Exclusions. (1) A handling oper- from certification. ation or portion of a handling oper- (a) Exemptions. (1) A production or ation is excluded from the require- handling operation that sells agricul- ments of this part, except for the re- tural products as ‘‘organic’’ but whose quirements for the prevention of com- gross agricultural income from organic mingling and contact with prohibited sales totals $5,000 or less annually is substances as set forth in § 205.272 with exempt from certification under sub- respect to any organically produced part E of this part and from submitting products, if such operation or portion an organic system plan for acceptance of the operation only sells organic agri- or approval under § 205.201 but must cultural products labeled as ‘‘100 per- comply with the applicable organic cent organic,’’ ‘‘organic,’’ or ‘‘made production and handling requirements with organic (specified ingredients or of subpart C of this part and the label- food group(s))’’ that: ing requirements of § 205.310. The prod- (i) Are packaged or otherwise en- ucts from such operations shall not be closed in a container prior to being re- used as ingredients identified as or- ceived or acquired by the operation; ganic in processed products produced and by another handling operation. (ii) Remain in the same package or (2) A handling operation that is a re- container and are not otherwise proc- tail food establishment or portion of a essed while in the control of the han- retail food establishment that handles dling operation. organically produced agricultural prod- (2) A handling operation that is a re- ucts but does not process them is ex- tail food establishment or portion of a empt from the requirements in this retail food establishment that proc- part. esses, on the premises of the retail food
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establishment, raw and ready-to-eat resented as ‘‘100 percent organic,’’ ‘‘or- food from agricultural products that ganic,’’ or ‘‘made with organic (speci- were previously labeled as ‘‘100 percent fied ingredients or food group(s)).’’ organic,’’ ‘‘organic,’’ or ‘‘made with or- (b) Such records must: ganic (specified ingredients or food (1) Be adapted to the particular busi- group(s))’’ is excluded from the require- ness that the certified operation is con- ments in this part, except: ducting; (i) The requirements for the preven- (2) Fully disclose all activities and tion of contact with prohibited sub- transactions of the certified operation stances as set forth in § 205.272; and in sufficient detail as to be readily un- (ii) The labeling provisions of derstood and audited; § 205.310. (c) Records to be maintained by exempt (3) Be maintained for not less than 5 operations. (1) Any handling operation years beyond their creation; and exempt from certification pursuant to (4) Be sufficient to demonstrate com- paragraph (a)(3) or (a)(4) of this section pliance with the Act and the regula- must maintain records sufficient to: tions in this part. (i) Prove that ingredients identified (c) The certified operation must as organic were organically produced make such records available for inspec- and handled; and tion and copying during normal busi- (ii) Verify quantities produced from ness hours by authorized representa- such ingredients. tives of the Secretary, the applicable (2) Records must be maintained for State program’s governing State offi- no less than 3 years beyond their cre- cial, and the certifying agent. ation and the operations must allow representatives of the Secretary and § 205.104 [Reserved] the applicable State organic programs’ governing State official access to these § 205.105 Allowed and prohibited sub- records for inspection and copying dur- stances, methods, and ingredients ing normal business hours to determine in organic production and han- compliance with the applicable regula- dling. tions set forth in this part. To be sold or labeled as ‘‘100 percent organic,’’ ‘‘organic,’’ or ‘‘made with or- § 205.102 Use of the term, ‘‘organic.’’ ganic (specified ingredients or food Any agricultural product that is sold, group(s)),’’ the product must be pro- labeled, or represented as ‘‘100 percent duced and handled without the use of: organic,’’ ‘‘organic,’’ or ‘‘made with or- (a) Synthetic substances and ingredi- ganic (specified ingredients or food ents, except as provided in § 205.601 or group(s))’’ must be: § 205.603; (a) Produced in accordance with the (b) Nonsynthetic substances prohib- requirements specified in § 205.101 or ited in § 205.602 or § 205.604; §§ 205.202 through 205.207 or §§ 205.236 (c) Nonagricultural substances used through 205.239 and all other applicable in or on processed products, except as requirements of part 205; and otherwise provided in § 205.605; (b) Handled in accordance with the (d) Nonorganic agricultural sub- requirements specified in § 205.101 or stances used in or on processed prod- §§ 205.270 through 205.272 and all other applicable requirements of this part ucts, except as otherwise provided in 205. § 205.606; (e) Excluded methods, except for vac- § 205.103 Recordkeeping by certified cines: Provided, That, the vaccines are operations. approved in accordance with (a) A certified operation must main- § 205.600(a); tain records concerning the production, (f) Ionizing radiation, as described in harvesting, and handling of agricul- Food and Drug Administration regula- tural products that are or that are in- tion, 21 CFR 179.26; and tended to be sold, labeled, or rep- (g) Sewage sludge.
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§§ 205.106–205.199 [Reserved] lished to prevent commingling of or- ganic and nonorganic products on a Subpart C—Organic Production split operation and to prevent contact and Handling Requirements of organic production and handling op- erations and products with prohibited § 205.200 General. substances; and (6) Additional information deemed The producer or handler of a produc- necessary by the certifying agent to tion or handling operation intending to evaluate compliance with the regula- sell, label, or represent agricultural tions. products as ‘‘100 percent organic,’’ ‘‘or- (b) A producer may substitute a plan ganic,’’ or ‘‘made with organic (speci- prepared to meet the requirements of fied ingredients or food group(s))’’ must comply with the applicable provisions another Federal, State, or local gov- of this subpart. Production practices ernment regulatory program for the or- implemented in accordance with this ganic system plan: Provided, That, the subpart must maintain or improve the submitted plan meets all the require- natural resources of the operation, in- ments of this subpart. cluding soil and water quality. § 205.202 Land requirements. § 205.201 Organic production and han- Any field or farm parcel from which dling system plan. harvested crops are intended to be sold, (a) The producer or handler of a pro- labeled, or represented as ‘‘organic,’’ duction or handling operation, except must: as exempt or excluded under § 205.101, (a) Have been managed in accordance intending to sell, label, or represent ag- with the provisions of §§ 205.203 through ricultural products as ‘‘100 percent or- 205.206; ganic,’’ ‘‘organic,’’ or ‘‘made with or- (b) Have had no prohibited sub- ganic (specified ingredients or food stances, as listed in § 205.105, applied to group(s))’’ must develop an organic it for a period of 3 years immediately production or handling system plan preceding harvest of the crop; and that is agreed to by the producer or (c) Have distinct, defined boundaries handler and an accredited certifying and buffer zones such as runoff diver- agent. An organic system plan must sions to prevent the unintended appli- meet the requirements set forth in this cation of a prohibited substance to the section for organic production or han- crop or contact with a prohibited sub- dling. An organic production or han- stance applied to adjoining land that is dling system plan must include: not under organic management. (1) A description of practices and pro- cedures to be performed and main- § 205.203 Soil fertility and crop nutri- tained, including the frequency with ent management practice standard. which they will be performed; (a) The producer must select and im- (2) A list of each substance to be used plement tillage and cultivation prac- as a production or handling input, indi- tices that maintain or improve the cating its composition, source, loca- physical, chemical, and biological con- tion(s) where it will be used, and docu- dition of soil and minimize soil ero- mentation of commercial availability, sion. as applicable; (b) The producer must manage crop (3) A description of the monitoring nutrients and soil fertility through ro- practices and procedures to be per- tations, cover crops, and the applica- formed and maintained, including the tion of plant and animal materials. frequency with which they will be per- (c) The producer must manage plant formed, to verify that the plan is effec- and animal materials to maintain or tively implemented; improve soil organic matter content in (4) A description of the recordkeeping a manner that does not contribute to system implemented to comply with contamination of crops, soil, or water the requirements established in by plant nutrients, pathogenic orga- § 205.103; nisms, heavy metals, or residues of pro- (5) A description of the management hibited substances. Animal and plant practices and physical barriers estab- materials include:
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(1) Raw animal manure, which must (5) A plant or animal material that be composted unless it is: has been chemically altered by a man- (i) Applied to land used for a crop not ufacturing process: Provided, That, the intended for human consumption; material is included on the National (ii) Incorporated into the soil not less List of synthetic substances allowed than 120 days prior to the harvest of a for use in organic crop production es- product whose edible portion has direct tablished in § 205.601. contact with the soil surface or soil (e) The producer must not use: particles; or (1) Any fertilizer or composted plant (iii) Incorporated into the soil not and animal material that contains a less than 90 days prior to the harvest of synthetic substance not included on a product whose edible portion does not the National List of synthetic sub- have direct contact with the soil sur- stances allowed for use in organic crop face or soil particles; production; (2) Composted plant and animal ma- (2) Sewage sludge (biosolids) as de- terials produced though a process that: fined in 40 CFR part 503; and (3) Burn- (i) Established an initial C:N ratio of ing as a means of disposal for crop resi- between 25:1 and 40:1; and dues produced on the operation: Except, (ii) Maintained a temperature of be- That, burning may be used to suppress tween 131 °F and 170 °F for 3 days using the spread of disease or to stimulate an in-vessel or static aerated pile sys- seed germination. tem; or (iii) Maintained a temperature of be- § 205.204 Seeds and planting stock tween 131 °F and 170 °F for 15 days practice standard. using a windrow composting system, (a) The producer must use organi- during which period, the materials cally grown seeds, annual seedlings, must be turned a minimum of five and planting stock: Except, That, times. (1) Nonorganically produced, un- (3) Uncomposted plant materials. treated seeds and planting stock may (d) A producer may manage crop nu- be used to produce an organic crop trients and soil fertility to maintain or when an equivalent organically pro- improve soil organic matter content in duced variety is not commercially a manner that does not contribute to available: Except, That, organically contamination of crops, soil, or water produced seed must be used for the pro- by plant nutrients, pathogenic orga- duction of edible sprouts; nisms, heavy metals, or residues of pro- (2) Nonorganically produced seeds hibited substances by applying: and planting stock that have been (1) A crop nutrient or soil amend- treated with a substance included on ment included on the National List of the National List of synthetic sub- synthetic substances allowed for use in stances allowed for use in organic crop organic crop production; production may be used to produce an (2) A mined substance of low solu- organic crop when an equivalent or- bility; ganically produced or untreated vari- (3) A mined substance of high solu- ety is not commercially available; bility: Provided, That, the substance is (3) Nonorganically produced annual used in compliance with the conditions seedlings may be used to produce an or- established on the National List of ganic crop when a temporary variance nonsynthetic materials prohibited for has been granted in accordance with crop production; § 205.290(a)(2); (4) Ash obtained from the burning of (4) Nonorganically produced planting a plant or animal material, except as stock to be used to produce a perennial prohibited in paragraph (e) of this sec- crop may be sold, labeled, or rep- tion: Provided, That, the material resented as organically produced only burned has not been treated or com- after the planting stock has been main- bined with a prohibited substance or tained under a system of organic man- the ash is not included on the National agement for a period of no less than 1 List of nonsynthetic substances prohib- year; and ited for use in organic crop production; (5) Seeds, annual seedlings, and and planting stock treated with prohibited
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substances may be used to produce an (5) Flame, heat, or electrical means; organic crop when the application of or the materials is a requirement of Fed- (6) Plastic or other synthetic eral or State phytosanitary regula- mulches: Provided, That, they are re- tions. moved from the field at the end of the (b) [Reserved] growing or harvest season. (d) Disease problems may be con- § 205.205 Crop rotation practice stand- trolled through: ard. (1) Management practices which sup- The producer must implement a crop press the spread of disease organisms; rotation including but not limited to or sod, cover crops, green manure crops, (2) Application of nonsynthetic bio- and catch crops that provide the fol- logical, botanical, or mineral inputs. lowing functions that are applicable to (e) When the practices provided for in the operation: paragraphs (a) through (d) of this sec- (a) Maintain or improve soil organic tion are insufficient to prevent or con- matter content; trol crop pests, weeds, and diseases, a (b) Provide for pest management in biological or botanical substance or a annual and perennial crops; substance included on the National (c) Manage deficient or excess plant List of synthetic substances allowed nutrients; and for use in organic crop production may (d) Provide erosion control. be applied to prevent, suppress, or con- § 205.206 Crop pest, weed, and disease trol pests, weeds, or diseases: Provided, management practice standard. That, the conditions for using the sub- stance are documented in the organic (a) The producer must use manage- system plan. ment practices to prevent crop pests, weeds, and diseases including but not (f) The producer must not use lumber limited to: treated with arsenate or other prohib- (1) Crop rotation and soil and crop ited materials for new installations or nutrient management practices, as pro- replacement purposes in contact with vided for in §§ 205.203 and 205.205; soil or livestock. (2) Sanitation measures to remove § 205.207 Wild-crop harvesting practice disease vectors, weed seeds, and habi- standard. tat for pest organisms; and (3) Cultural practices that enhance (a) A wild crop that is intended to be crop health, including selection of sold, labeled, or represented as organic plant species and varieties with regard must be harvested from a designated to suitability to site-specific condi- area that has had no prohibited sub- tions and resistance to prevalent pests, stance, as set forth in § 205.105, applied weeds, and diseases. to it for a period of 3 years imme- (b) Pest problems may be controlled diately preceding the harvest of the through mechanical or physical meth- wild crop. ods including but not limited to: (b) A wild crop must be harvested in (1) Augmentation or introduction of a manner that ensures that such har- predators or parasites of the pest spe- vesting or gathering will not be de- cies; structive to the environment and will (2) Development of habitat for nat- sustain the growth and production of ural enemies of pests; the wild crop. (3) Nonsynthetic controls such as lures, traps, and repellents. §§ 205.208—205.235 [Reserved] (c) Weed problems may be controlled through: § 205.236 Origin of livestock. (1) Mulching with fully biodegradable (a) Livestock products that are to be materials; sold, labeled, or represented as organic (2) Mowing; must be from livestock under contin- (3) Livestock grazing; uous organic management from the (4) Hand weeding and mechanical cul- last third of gestation or hatching: Ex- tivation; cept, That:
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(1) Poultry. Poultry or edible poultry with a total feed ration composed of products must be from poultry that has agricultural products, including pas- been under continuous organic man- ture and forage, that are organically agement beginning no later than the produced and, if applicable, organically second day of life; handled: Except, That, nonsynthetic (2) Dairy animals. Milk or milk prod- substances and synthetic substances ucts must be from animals that have allowed under § 205.603 may be used as been under continuous organic man- feed additives and supplements. agement beginning no later than 1 year (b) The producer of an organic oper- prior to the production of the milk or ation must not: milk products that are to be sold, la- (1) Use animal drugs, including hor- beled, or represented as organic: Ex- mones, to promote growth; cept, That, when an entire, distinct (2) Provide feed supplements or addi- herd is converted to organic produc- tives in amounts above those needed tion, the producer may: for adequate nutrition and health (i) For the first 9 months of the year, maintenance for the species at its spe- provide a minimum of 80-percent feed cific stage of life; that is either organic or raised from (3) Feed plastic pellets for roughage; land included in the organic system (4) Feed formulas containing urea or plan and managed in compliance with manure; organic crop requirements; and (5) Feed mammalian or poultry (ii) Provide feed in compliance with slaughter by-products to mammals or § 205.237 for the final 3 months. poultry; or (iii) Once an entire, distinct herd has (6) Use feed, feed additives, and feed been converted to organic production, supplements in violation of the Federal all dairy animals shall be under or- Food, Drug, and Cosmetic Act. ganic management from the last third of gestation. § 205.238 Livestock health care prac- (3) Breeder stock. Livestock used as tice standard. breeder stock may be brought from a nonorganic operation onto an organic (a) The producer must establish and operation at any time: Provided, That, maintain preventive livestock health if such livestock are gestating and the care practices, including: offspring are to be raised as organic (1) Selection of species and types of livestock, the breeder stock must be livestock with regard to suitability for brought onto the facility no later than site-specific conditions and resistance the last third of gestation. to prevalent diseases and parasites; (b) The following are prohibited: (2) Provision of a feed ration suffi- (1) Livestock or edible livestock cient to meet nutritional require- products that are removed from an or- ments, including vitamins, minerals, ganic operation and subsequently man- protein and/or amino acids, fatty acids, aged on a nonorganic operation may be energy sources, and fiber (ruminants); not sold, labeled, or represented as or- (3) Establishment of appropriate ganically produced. housing, pasture conditions, and sani- (2) Breeder or dairy stock that has tation practices to minimize the occur- not been under continuous organic rence and spread of diseases and management since the last third of ges- parasites; tation may not be sold, labeled, or rep- (4) Provision of conditions which resented as organic slaughter stock. allow for exercise, freedom of move- (c) The producer of an organic live- ment, and reduction of stress appro- stock operation must maintain records priate to the species; sufficient to preserve the identity of (5) Performance of physical alter- all organically managed animals and ations as needed to promote the ani- edible and nonedible animal products mal’s welfare and in a manner that produced on the operation. minimizes pain and stress; and (6) Administration of vaccines and § 205.237 Livestock feed. other veterinary biologics. (a) The producer of an organic live- (b) When preventive practices and stock operation must provide livestock veterinary biologics are inadequate to
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prevent sickness, a producer may ad- (2) Access to pasture for ruminants; minister synthetic medications: Pro- (3) Appropriate clean, dry bedding. If vided, That, such medications are al- the bedding is typically consumed by lowed under § 205.603. Parasiticides al- the animal species, it must comply lowed under § 205.603 may be used on: with the feed requirements of § 205.237; (1) Breeder stock, when used prior to (4) Shelter designed to allow for: the last third of gestation but not dur- (i) Natural maintenance, comfort be- ing lactation for progeny that are to be haviors, and opportunity to exercise; sold, labeled, or represented as organi- (ii) Temperature level, ventilation, cally produced; and and air circulation suitable to the spe- (2) Dairy stock, when used a min- cies; and imum of 90 days prior to the produc- (iii) Reduction of potential for live- tion of milk or milk products that are stock injury; to be sold, labeled, or represented as (b) The producer of an organic live- organic. stock operation may provide tem- (c) The producer of an organic live- porary confinement for an animal be- stock operation must not: cause of: (1) Sell, label, or represent as organic (1) Inclement weather; any animal or edible product derived (2) The animal’s stage of production; from any animal treated with anti- (3) Conditions under which the biotics, any substance that contains a health, safety, or well being of the ani- synthetic substance not allowed under mal could be jeopardized; or § 205.603, or any substance that contains (4) Risk to soil or water quality. a nonsynthetic substance prohibited in (c) The producer of an organic live- § 205.604. stock operation must manage manure (2) Administer any animal drug, in a manner that does not contribute other than vaccinations, in the absence to contamination of crops, soil, or of illness; water by plant nutrients, heavy met- (3) Administer hormones for growth als, or pathogenic organisms and opti- promotion; mizes recycling of nutrients. (4) Administer synthetic parasiticides on a routine basis; §§ 205.240—205.269 [Reserved] (5) Administer synthetic parasiticides to slaughter stock; § 205.270 Organic handling require- (6) Administer animal drugs in viola- ments. tion of the Federal Food, Drug, and (a) Mechanical or biological methods, Cosmetic Act; or including but not limited to cooking, (7) Withhold medical treatment from baking, curing, heating, drying, mix- a sick animal in an effort to preserve ing, grinding, churning, separating, its organic status. All appropriate distilling, extracting, slaughtering, medications must be used to restore an cutting, fermenting, eviscerating, pre- animal to health when methods accept- serving, dehydrating, freezing, chilling, able to organic production fail. Live- or otherwise manufacturing, and the stock treated with a prohibited sub- packaging, canning, jarring, or other- stance must be clearly identified and wise enclosing food in a container may shall not be sold, labeled, or rep- be used to process an organically pro- resented as organically produced. duced agricultural product for the pur- pose of retarding spoilage or otherwise § 205.239 Livestock living conditions. preparing the agricultural product for (a) The producer of an organic live- market. stock operation must establish and (b) Nonagricultural substances al- maintain livestock living conditions lowed under § 205.605 and nonorgani- which accommodate the health and cally produced agricultural products natural behavior of animals, including: allowed under § 205.606 may be used: (1) Access to the outdoors, shade, (1) In or on a processed agricultural shelter, exercise areas, fresh air, and product intended to be sold, labeled, or direct sunlight suitable to the species, represented as ‘‘organic,’’ pursuant to its stage of production, the climate, § 205.301(b), if not commercially avail- and the environment; able in organic form.
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(2) In or on a processed agricultural measures to be taken to prevent con- product intended to be sold, labeled, or tact of the organically produced prod- represented as ‘‘made with organic ucts or ingredients with the substance (specified ingredients or food used. group(s)),’’ pursuant to § 205.301(c). (e) The handler of an organic han- (c) The handler of an organic han- dling operation who applies a nonsyn- dling operation must not use in or on thetic or synthetic substance to pre- agricultural products intended to be vent or control pests must update the sold, labeled, or represented as ‘‘100 operation’s organic handling plan to percent organic,’’ ‘‘organic,’’ or ‘‘made reflect the use of such substances and with organic (specified ingredients or methods of application. The updated food group(s)),’’ or in or on any ingredi- organic plan must include a list of all ents labeled as organic: (1) Practices prohibited under para- measures taken to prevent contact of graphs (e) and (f) of § 205.105. the organically produced products or (2) A volatile synthetic solvent or ingredients with the substance used. other synthetic processing aid not al- (f) Notwithstanding the practices lowed under § 205.605: Except, That, non- provided for in paragraphs (a), (b), (c), organic ingredients in products labeled and (d) of this section, a handler may ‘‘made with organic (specified ingredi- otherwise use substances to prevent or ents or food group(s))’’ are not subject control pests as required by Federal, to this requirement. State, or local laws and regulations: Provided, That, measures are taken to § 205.271 Facility pest management prevent contact of the organically pro- practice standard. duced products or ingredients with the (a) The producer or handler of an or- substance used. ganic facility must use management practices to prevent pests, including § 205.272 Commingling and contact but not limited to: with prohibited substance preven- (1) Removal of pest habitat, food tion practice standard. sources, and breeding areas; (a) The handler of an organic han- (2) Prevention of access to handling dling operation must implement meas- facilities; and (3) Management of environmental ures necessary to prevent the commin- factors, such as temperature, light, hu- gling of organic and nonorganic prod- midity, atmosphere, and air circula- ucts and protect organic products from tion, to prevent pest reproduction. contact with prohibited substances. (b) Pests may be controlled through: (b) The following are prohibited for (1) Mechanical or physical controls use in the handling of any organically including but not limited to traps, produced agricultural product or ingre- light, or sound; or dient labeled in accordance with sub- (2) Lures and repellents using non- part D of this part: synthetic or synthetic substances con- (1) Packaging materials, and storage sistent with the National List. containers, or bins that contain a syn- (c) If the practices provided for in thetic fungicide, preservative, or fumi- paragraphs (a) and (b) of this section gant; are not effective to prevent or control (2) The use or reuse of any bag or pests, a nonsynthetic or synthetic sub- container that has been in contact stance consistent with the National with any substance in such a manner List may be applied. as to compromise the organic integrity (d) If the practices provided for in of any organically produced product or paragraphs (a), (b), and (c) of this sec- tion are not effective to prevent or con- ingredient placed in those containers, trol facility pests, a synthetic sub- unless such reusable bag or container stance not on the National List may be has been thoroughly cleaned and poses applied: Provided, That, the handler no risk of contact of the organically and certifying agent agree on the sub- produced product or ingredient with stance, method of application, and the substance used.
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§§ 205.273—205.289 [Reserved] produced and handled in accordance with the regulations in this part. The § 205.290 Temporary variances. term, ‘‘organic,’’ may not be used in a (a) Temporary variances from the re- product name to modify a nonorganic quirements in §§ 205.203 through 205.207, ingredient in the product. 205.236 through 205.239, and 205.270 (b) Products for export, produced and through 205.272 may be established by certified to foreign national organic the Administrator for the following standards or foreign contract buyer re- reasons: quirements, may be labeled in accord- (1) Natural disasters declared by the ance with the organic labeling require- Secretary; ments of the receiving country or con- (2) Damage caused by drought, wind, tract buyer: Provided, That, the ship- flood, excessive moisture, hail, tor- ping containers and shipping docu- nado, earthquake, fire, or other busi- ments meet the labeling requirements ness interruption; and specified in § 205.307(c). (3) Practices used for the purpose of (c) Products produced in a foreign conducting research or trials of tech- country and exported for sale in the niques, varieties, or ingredients used in United States must be certified pursu- organic production or handling. ant to subpart E of this part and la- (b) A State organic program’s gov- beled pursuant to this subpart D. erning State official or certifying (d) Livestock feeds produced in ac- agent may recommend in writing to cordance with the requirements of this the Administrator that a temporary part must be labeled in accordance variance from a standard set forth in with the requirements of § 205.306. subpart C of this part for organic pro- duction or handling operations be es- § 205.301 Product composition. tablished: Provided, That, such vari- (a) Products sold, labeled, or rep- ance is based on one or more of the rea- resented as ‘‘100 percent organic.’’ A raw sons listed in paragraph (a) of this sec- or processed agricultural product sold, tion. labeled, or represented as ‘‘100 percent (c) The Administrator will provide organic’’ must contain (by weight or written notification to certifying fluid volume, excluding water and salt) agents upon establishment of a tem- 100 percent organically produced ingre- porary variance applicable to the certi- dients. If labeled as organically pro- fying agent’s certified production or duced, such product must be labeled handling operations and specify the pe- pursuant to § 205.303. riod of time it shall remain in effect, (b) Products sold, labeled, or rep- subject to extension as the Adminis- resented as ‘‘organic.’’ A raw or proc- trator deems necessary. essed agricultural product sold, la- (d) A certifying agent, upon notifica- beled, or represented as ‘‘organic’’ tion from the Administrator of the es- must contain (by weight or fluid vol- tablishment of a temporary variance, ume, excluding water and salt) not less must notify each production or han- than 95 percent organically produced dling operation it certifies to which the raw or processed agricultural products. temporary variance applies. Any remaining product ingredients (e) Temporary variances will not be must be organically produced, unless granted for any practice, material, or not commercially available in organic procedure prohibited under § 205.105. form, or must be nonagricultural sub- stances or nonorganically produced ag- §§ 205.291–205.299 [Reserved] ricultural products produced consistent with the National List in subpart G of Subpart D—Labels, Labeling, and this part. If labeled as organically pro- Market Information duced, such product must be labeled pursuant to § 205.303. § 205.300 Use of the term, ‘‘organic.’’ (c) Products sold, labeled, or rep- (a) The term, ‘‘organic,’’ may only be resented as ‘‘made with organic (specified used on labels and in labeling of raw or ingredients or food group(s)).’’ Multi- processed agricultural products, in- ingredient agricultural product sold, cluding ingredients, that have been labeled, or represented as ‘‘made with
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organic (specified ingredients or food (4) Be processed using processing aids group(s))’’ must contain (by weight or not approved on the National List of fluid volume, excluding water and salt) Allowed and Prohibited Substances in at least 70 percent organically pro- subpart G of this part: Except, That, duced ingredients which are produced products labeled as ‘‘100 percent or- and handled pursuant to requirements ganic,’’ if processed, must be processed in subpart C of this part. No ingredi- using organically produced processing ents may be produced using prohibited aids; practices specified in paragraphs (f)(1), (5) Contain sulfites, nitrates, or (2), and (3) of § 205.301. Nonorganic in- nitrites added during the production or gredients may be produced without re- handling process, Except, that, wine gard to paragraphs (f)(4), (5), (6), and (7) containing added sulfites may be la- of § 205.301. If labeled as containing or- beled ‘‘made with organic grapes’’; ganically produced ingredients or food (6) Be produced using nonorganic in- groups, such product must be labeled gredients when organic ingredients are pursuant to § 205.304. available; or (d) Products with less than 70 percent (7) Include organic and nonorganic organically produced ingredients. The or- forms of the same ingredient. ganic ingredients in multiingredient agricultural product containing less § 205.302 Calculating the percentage of than 70 percent organically produced organically produced ingredients. ingredients (by weight or fluid volume, (a) The percentage of all organically excluding water and salt) must be pro- produced ingredients in an agricultural duced and handled pursuant to require- product sold, labeled, or represented as ments in subpart C of this part. The ‘‘100 percent organic,’’ ‘‘organic,’’ or nonorganic ingredients may be pro- ‘‘made with organic (specified ingredi- duced and handled without regard to ents or food group(s)),’’ or that include the requirements of this part. Multi- organic ingredients must be calculated ingredient agricultural product con- by: taining less than 70 percent organically (1) Dividing the total net weight (ex- produced ingredients may represent cluding water and salt) of combined or- the organic nature of the product only ganic ingredients at formulation by the as provided in § 205.305. total weight (excluding water and salt) (e) Livestock feed. (1) A raw or proc- of the finished product. essed livestock feed product sold, la- (2) Dividing the fluid volume of all beled, or represented as ‘‘100 percent organic ingredients (excluding water organic’’ must contain (by weight or and salt) by the fluid volume of the fin- fluid volume, excluding water and salt) ished product (excluding water and not less than 100 percent organically salt) if the product and ingredients are produced raw or processed agricultural liquid. If the liquid product is identi- product. fied on the principal display panel or (2) A raw or processed livestock feed information panel as being reconsti- product sold, labeled, or represented as tuted from concentrates, the calcula- ‘‘organic’’ must be produced in con- tion should be made on the basis of sin- formance with § 205.237. gle-strength concentrations of the in- (f) All products labeled as ‘‘100 per- gredients and finished product. cent organic’’ or ‘‘organic’’ and all in- (3) For products containing organi- gredients identified as ‘‘organic’’ in the cally produced ingredients in both solid ingredient statement of any product and liquid form, dividing the combined must not: weight of the solid ingredients and the (1) Be produced using excluded meth- weight of the liquid ingredients (ex- ods, pursuant to § 201.105(e) of this cluding water and salt) by the total chapter; weight (excluding water and salt) of (2) Be produced using sewage sludge, the finished product. pursuant to § 201.105(f) of this chapter; (b) The percentage of all organically (3) Be processed using ionizing radi- produced ingredients in an agricultural ation, pursuant to § 201.105(g) of this product must be rounded down to the chapter; nearest whole number.
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(c) The percentage must be deter- the ingredient is organically produced. mined by the handler who affixes the Water or salt included as ingredients label on the consumer package and cannot be identified as organic. verified by the certifying agent of the (2) On the information panel, below handler. The handler may use informa- the information identifying the han- tion provided by the certified operation dler or distributor of the product and in determining the percentage. preceded by the statement, ‘‘Certified organic by * * *,’’ or similar phrase, § 205.303 Packaged products labeled identify the name of the certifying ‘‘100 percent organic’’ or ‘‘organic.’’ agent that certified the handler of the (a) Agricultural products in packages finished product and may display the described in § 205.301(a) and (b) may dis- business address, Internet address, or play, on the principal display panel, in- telephone number of the certifying formation panel, and any other panel agent in such label. of the package and on any labeling or market information concerning the § 205.304 Packaged products labeled product, the following: ‘‘made with organic (specified in- (1) The term, ‘‘100 percent organic’’ gredients or food group(s)).’’ or ‘‘organic,’’ as applicable, to modify (a) Agricultural products in packages the name of the product; described in § 205.301(c) may display on (2) For products labeled ‘‘organic,’’ the principal display panel, informa- the percentage of organic ingredients tion panel, and any other panel and on in the product; (The size of the percent- any labeling or market information age statement must not exceed one- concerning the product: half the size of the largest type size on (1) The statement: the panel on which the statement is (i) ‘‘Made with organic (specified in- displayed and must appear in its en- tirety in the same type size, style, and gredients)’’: Provided, That, the state- color without highlighting.) ment does not list more than three or- (3) The term, ‘‘organic,’’ to identify ganically produced ingredients; or the organic ingredients in multiingre- (ii) ‘‘Made with organic (specified dient products labeled ‘‘100 percent or- food groups)’’: Provided, That, the ganic’’; statement does not list more than (4) The USDA seal; and/or three of the following food groups: (5) The seal, logo, or other identi- beans, fish, fruits, grains, herbs, meats, fying mark of the certifying agent nuts, oils, poultry, seeds, spices, sweet- which certified the production or han- eners, and vegetables or processed milk dling operation producing the finished products; and, Provided further, That, product and any other certifying agent all ingredients of each listed food which certified production or handling group in the product must be organi- operations producing raw organic prod- cally produced; and uct or organic ingredients used in the (iii) Which appears in letters that do finished product: Provided, That, the not exceed one-half the size of the larg- handler producing the finished product est type size on the panel and which maintain records, pursuant to this appears in its entirety in the same type part, verifying organic certification of size, style, and color without high- the operations producing such ingredi- lighting. ents, and: Provided further, That, such (2) The percentage of organic ingredi- seals or marks are not individually dis- ents in the product. The size of the per- played more prominently than the centage statement must not exceed USDA seal. one-half the size of the largest type (b) Agricultural products in packages size on the panel on which the state- described in § 205.301(a) and (b) must: ment is displayed and must appear in (1) For products labeled ‘‘organic,’’ its entirety in the same type size, identify each organic ingredient in the style, and color without highlighting. ingredient statement with the word, (3) The seal, logo, or other identi- ‘‘organic,’’ or with an asterisk or other fying mark of the certifying agent that reference mark which is defined below certified the handler of the finished the ingredient statement to indicate product.
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(b) Agricultural products in packages (1) The statement, ‘‘100 percent or- described in § 205.301(c) must: ganic’’ or ‘‘organic,’’ as applicable, to (1) In the ingredient statement, iden- modify the name of the feed product; tify each organic ingredient with the (2) The USDA seal; word, ‘‘organic,’’ or with an asterisk or (3) The seal, logo, or other identi- other reference mark which is defined fying mark of the certifying agent below the ingredient statement to indi- which certified the production or han- cate the ingredient is organically pro- dling operation producing the raw or duced. Water or salt included as ingre- processed organic ingredients used in dients cannot be identified as organic. the finished product, Provided, That, (2) On the information panel, below such seals or marks are not displayed the information identifying the han- more prominently than the USDA seal; dler or distributor of the product and (4) The word, ‘‘organic,’’ or an aster- preceded by the statement, ‘‘Certified isk or other reference mark which is organic by * * *,’’ or similar phrase, defined on the package to identify in- identify the name of the certifying gredients that are organically pro- agent that certified the handler of the duced. Water or salt included as ingre- finished product: Except, That, the dients cannot be identified as organic. business address, Internet address, or (b) Livestock feed products described telephone number of the certifying in § 205.301(e)(1) and (e)(2) must: (1) On the information panel, below agent may be included in such label. the information identifying the han- (c) Agricultural products in packages dler or distributor of the product and described in § 205.301(c) must not dis- preceded by the statement, ‘‘Certified play the USDA seal. organic by * * *,’’ or similar phrase, display the name of the certifying § 205.305 Multi-ingredient packaged products with less than 70 percent agent that certified the handler of the organically produced ingredients. finished product. The business address, Internet address, or telephone number (a) An agricultural product with less of the certifying agent may be included than 70 percent organically produced in such label. ingredients may only identify the or- (2) Comply with other Federal agency ganic content of the product by: or State feed labeling requirements as (1) Identifying each organically pro- applicable. duced ingredient in the ingredient statement with the word, ‘‘organic,’’ or § 205.307 Labeling of nonretail con- with an asterisk or other reference tainers used for only shipping or mark which is defined below the ingre- storage of raw or processed agricul- dient statement to indicate the ingre- tural products labeled as ‘‘100 per- dient is organically produced, and cent organic,’’ ‘‘organic,’’ or ‘‘made with organic (specified ingredients (2) If the organically produced ingre- or food group(s)).’’ dients are identified in the ingredient statement, displaying the product’s (a) Nonretail containers used only to percentage of organic contents on the ship or store raw or processed agricul- information panel. tural product labeled as containing or- ganic ingredients may display the fol- (b) Agricultural products with less lowing terms or marks: than 70 percent organically produced (1) The name and contact informa- ingredients must not display: tion of the certifying agent which cer- (1) The USDA seal; and tified the handler which assembled the (2) Any certifying agent seal, logo, or final product; other identifying mark which rep- (2) Identification of the product as resents organic certification of a prod- organic; uct or product ingredients. (3) Special handling instructions needed to maintain the organic integ- § 205.306 Labeling of livestock feed. rity of the product; (a) Livestock feed products described (4) The USDA seal; in § 205.301(e)(1) and (e)(2) may display (5) The seal, logo, or other identi- on any package panel the following fying mark of the certifying agent that terms: certified the organic production or
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handling operation that produced or § 205.309 Agricultural products in handled the finished product. other than packaged form at the (b) Nonretail containers used to ship point of retail sale that are sold, la- or store raw or processed agricultural beled, or represented as ‘‘made with organic (specified ingredients or product labeled as containing organic food group(s)).’’ ingredients must display the produc- tion lot number of the product if appli- (a) Agricultural products in other cable. than packaged form containing be- (c) Shipping containers of domesti- tween 70 and 95 percent organically cally produced product labeled as or- produced ingredients may use the phrase, ‘‘made with organic (specified ganic intended for export to inter- ingredients or food group(s)),’’ to mod- national markets may be labeled in ac- ify the name of the product in retail cordance with any shipping container display, labeling, and display con- labeling requirements of the foreign tainers. country of destination or the container (1) Such statement must not list labeling specifications of a foreign con- more than three organic ingredients or tract buyer: Provided, That, the ship- food groups, and ping containers and shipping docu- (2) In any such display of the prod- ments accompanying such organic uct’s ingredient statement, the organic products are clearly marked ‘‘For Ex- ingredients are identified as ‘‘organic.’’ port Only’’ and: Provided further, That, (b) If prepared in a certified facility, proof of such container marking and such agricultural products labeled as export must be maintained by the han- ‘‘made with organic (specified ingredi- dler in accordance with recordkeeping ents or food group(s))’’ in retail dis- requirements for exempt and excluded plays, display containers, and market operations under § 205.101. information may display the certifying agent’s seal, logo, or other identifying § 205.308 Agricultural products in mark. other than packaged form at the point of retail sale that are sold, la- § 205.310 Agricultural products pro- beled, or represented as ‘‘100 per- duced on an exempt or excluded op- cent organic’’ or ‘‘organic.’’ eration. (a) Agricultural products in other (a) An agricultural product organi- than packaged form may use the term, cally produced or handled on an ex- ‘‘100 percent organic’’ or ‘‘organic,’’ as empt or excluded operation must not: applicable, to modify the name of the (1) Display the USDA seal or any cer- product in retail display, labeling, and tifying agent’s seal or other identifying display containers: Provided, That, the mark which represents the exempt or term, ‘‘organic,’’ is used to identify the excluded operation as a certified or- organic ingredients listed in the ingre- ganic operation, or dient statement. (2) Be represented as a certified or- (b) If the product is prepared in a cer- ganic product or certified organic in- tified facility, the retail display, label- gredient to any buyer. ing, and display containers may use: (b) An agricultural product organi- (1) The USDA seal; and cally produced or handled on an ex- (2) The seal, logo, or other identi- empt or excluded operation may be fying mark of the certifying agent that identified as an organic product or or- certified the production or handling op- ganic ingredient in a multiingredient eration producing the finished product product produced by the exempt or ex- and any other certifying agent which cluded operation. Such product or in- certified operations producing raw or- gredient must not be identified or rep- ganic product or organic ingredients resented as ‘‘organic’’ in a product used in the finished product: Provided, processed by others. That, such seals or marks are not indi- (c) Such product is subject to re- vidually displayed more prominently quirements specified in paragraph (a) than the USDA seal. of § 205.300, and paragraphs (f)(1) through (f)(7) of § 205.301.
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§ 205.311 USDA Seal. dling system plan that is submitted to (a) The USDA seal described in para- an accredited certifying agent as pro- graphs (b) and (c) of this section may vided for in § 205.200; be used only for raw or processed agri- (c) Permit on-site inspections with cultural products described in para- complete access to the production or graphs (a), (b), (e)(1), and (e)(2) of handling operation, including noncer- § 205.301. tified production and handling areas, (b) The USDA seal must replicate the structures, and offices by the certi- form and design of the example in fig- fying agent as provided for in § 205.403; ure 1 and must be printed legibly and (d) Maintain all records applicable to conspicuously: the organic operation for not less than (1) On a white background with a 5 years beyond their creation and allow brown outer circle and with the term, authorized representatives of the Sec- ‘‘USDA,’’ in green overlaying a white retary, the applicable State organic upper semicircle and with the term, program’s governing State official, and ‘‘organic,’’ in white overlaying the the certifying agent access to such green lower half circle; or records during normal business hours (2) On a white or transparent back- for review and copying to determine ground with black outer circle and compliance with the Act and the regu- black ‘‘USDA’’ on a white or trans- lations in this part, as provided for in parent upper half of the circle with a § 205.104; contrasting white or transparent ‘‘or- (e) Submit the applicable fees ganic’’ on the black lower half circle. charged by the certifying agent; and (3) The green or black lower half cir- (f) Immediately notify the certifying cle may have four light lines running agent concerning any: from left to right and disappearing at (1) Application, including drift, of a the point on the right horizon to re- prohibited substance to any field, pro- semble a cultivated field. duction unit, site, facility, livestock, or product that is part of an operation; and (2) Change in a certified operation or any portion of a certified operation that may affect its compliance with the Act and the regulations in this part.
§ 205.401 Application for certification. A person seeking certification of a production or handling operation under this subpart must submit an applica- tion for certification to a certifying agent. The application must include the following information: (a) An organic production or han- dling system plan, as required in §§ 205.312–205.399 [Reserved] § 205.200; (b) The name of the person com- Subpart E—Certification pleting the application; the applicant’s business name, address, and telephone § 205.400 General requirements for number; and, when the applicant is a certification. corporation, the name, address, and A person seeking to receive or main- telephone number of the person author- tain organic certification under the ized to act on the applicant’s behalf; regulations in this part must: (c) The name(s) of any organic certi- (a) Comply with the Act and applica- fying agent(s) to which application has ble organic production and handling previously been made; the year(s) of regulations of this part; application; the outcome of the appli- (b) Establish, implement, and update cation(s) submission, including, when annually an organic production or han- available, a copy of any notification of
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noncompliance or denial of certifi- the issuance of a notice of noncompli- cation issued to the applicant for cer- ance will not be issued a notice of non- tification; and a description of the ac- compliance. Similarly, an applicant tions taken by the applicant to correct that voluntarily withdrew its applica- the noncompliances noted in the notifi- tion prior to the issuance of a notice of cation of noncompliance, including evi- certification denial will not be issued a dence of such correction; and notice of certification denial. (d) Other information necessary to determine compliance with the Act and § 205.403 On-site inspections. the regulations in this part. (a) On-site inspections. (1) A certifying agent must conduct an initial on-site § 205.402 Review of application. inspection of each production unit, fa- (a) Upon acceptance of an application cility, and site that produces or han- for certification, a certifying agent dles organic products and that is in- must: cluded in an operation for which cer- (1) Review the application to ensure tification is requested. An on-site in- completeness pursuant to § 205.401; spection shall be conducted annually (2) Determine by a review of the ap- thereafter for each certified operation plication materials whether the appli- that produces or handles organic prod- cant appears to comply or may be able ucts for the purpose of determining to comply with the applicable require- whether to approve the request for cer- ments of subpart C of this part; tification or whether the certification (3) Verify that an applicant who pre- of the operation should continue. viously applied to another certifying (2) (i) A certifying agent may conduct agent and received a notification of additional on-site inspections of appli- noncompliance or denial of certifi- cants for certification and certified op- cation, pursuant to § 205.405, has sub- erations to determine compliance with mitted documentation to support the the Act and the regulations in this correction of any noncompliances iden- part. tified in the notification of noncompli- (ii) The Administrator or State or- ance or denial of certification, as re- ganic program’s governing State offi- quired in § 205.405(e); and cial may require that additional in- (4) Schedule an on-site inspection of spections be performed by the certi- the operation to determine whether the fying agent for the purpose of deter- applicant qualifies for certification if mining compliance with the Act and the review of application materials re- the regulations in this part. veals that the production or handling (iii) Additional inspections may be operation may be in compliance with announced or unannounced at the dis- the applicable requirements of subpart cretion of the certifying agent or as re- C of this part. quired by the Administrator or State (b) The certifying agent shall within organic program’s governing State offi- a reasonable time: cial. (1) Review the application materials (b) Scheduling. (1) The initial on-site received and communicate its findings inspection must be conducted within a to the applicant; reasonable time following a determina- (2) Provide the applicant with a copy tion that the applicant appears to com- of the on-site inspection report, as ap- ply or may be able to comply with the proved by the certifying agent, for any requirements of subpart C of this part: on-site inspection performed; and Except, That, the initial inspection (3) Provide the applicant with a copy may be delayed for up to 6 months to of the test results for any samples comply with the requirement that the taken by an inspector. inspection be conducted when the land, (c) The applicant may withdraw its facilities, and activities that dem- application at any time. An applicant onstrate compliance or capacity to who withdraws its application shall be comply can be observed. liable for the costs of services provided (2) All on-site inspections must be up to the time of withdrawal of its ap- conducted when an authorized rep- plication. An applicant that volun- resentative of the operation who is tarily withdrew its application prior to knowledgeable about the operation is
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present and at a time when land, facili- tion requested from or supplied by the ties, and activities that demonstrate applicant. If the certifying agent deter- the operation’s compliance with or ca- mines that the organic system plan pability to comply with the applicable and all procedures and activities of the provisions of subpart C of this part can applicant’s operation are in compliance be observed, except that this require- with the requirements of this part and ment does not apply to unannounced that the applicant is able to conduct on-site inspections. operations in accordance with the plan, (c) Verification of information. The on- the agent shall grant certification. The site inspection of an operation must certification may include requirements verify: for the correction of minor noncompli- (1) The operation’s compliance or ca- ances within a specified time period as pability to comply with the Act and a condition of continued certification. the regulations in this part; (b) The certifying agent must issue a (2) That the information, including certificate of organic operation which the organic production or handling sys- specifies the: tem plan, provided in accordance with (1) Name and address of the certified §§ 205.401, 205.406, and 205.200, accurately operation; reflects the practices used or to be used (2) Effective date of certification; by the applicant for certification or by (3) Categories of organic operation, the certified operation; including crops, wild crops, livestock, (3) That prohibited substances have or processed products produced by the not been and are not being applied to certified operation; and the operation through means which, at (4) Name, address, and telephone the discretion of the certifying agent, number of the certifying agent. may include the collection and testing (c) Once certified, a production or of soil; water; waste; seeds; plant tis- handling operation’s organic certifi- sue; and plant, animal, and processed cation continues in effect until surren- products samples. dered by the organic operation or sus- (d) Exit interview. The inspector must pended or revoked by the certifying conduct an exit interview with an au- agent, the State organic program’s thorized representative of the oper- governing State official, or the Admin- ation who is knowledgeable about the istrator. inspected operation to confirm the ac- curacy and completeness of inspection § 205.405 Denial of certification. observations and information gathered (a) When the certifying agent has during the on-site inspection. The in- reason to believe, based on a review of spector must also address the need for the information specified in § 205.402 or any additional information as well as § 205.404, that an applicant for certifi- any issues of concern. cation is not able to comply or is not (e) Documents to the inspected oper- in compliance with the requirements of ation. (1) At the time of the inspection, this part, the certifying agent must the inspector shall provide the oper- provide a written notification of non- ation’s authorized representative with compliance to the applicant. When cor- a receipt for any samples taken by the rection of a noncompliance is not pos- inspector. There shall be no charge to sible, a notification of noncompliance the inspector for the samples taken. and a notification of denial of certifi- (2) A copy of the on-site inspection cation may be combined in one notifi- report and any test results will be sent cation. The notification of noncompli- to the inspected operation by the certi- ance shall provide: fying agent. (1) A description of each noncompli- ance; § 205.404 Granting certification. (2) The facts upon which the notifica- (a) Within a reasonable time after tion of noncompliance is based; and completion of the initial on-site in- (3) The date by which the applicant spection, a certifying agent must re- must rebut or correct each noncompli- view the on-site inspection report, the ance and submit supporting docu- results of any analyses for substances mentation of each such correction conducted, and any additional informa- when correction is possible.
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(b) Upon receipt of such notification denial of certification may apply for of noncompliance, the applicant may: certification again at any time with (1) Correct noncompliances and sub- any certifying agent, in accordance mit a description of the corrective ac- with §§ 205.401 and 205.405(e). When such tions taken with supporting docu- applicant submits a new application to mentation to the certifying agent; a certifying agent other than the agent (2) Correct noncompliances and sub- who issued the notification of non- mit a new application to another certi- compliance or notice of denial of cer- fying agent: Provided, That, the appli- tification, the applicant for certifi- cant must include a complete applica- cation must include a copy of the noti- tion, the notification of noncompliance fication of noncompliance or notice of received from the first certifying denial of certification and a descrip- agent, and a description of the correc- tion of the actions taken, with sup- tive actions taken with supporting doc- porting documentation, to correct the umentation; or noncompliances noted in the notifica- (3) Submit written information to tion of noncompliance. the issuing certifying agent to rebut (f) A certifying agent who receives a the noncompliance described in the no- new application for certification, tification of noncompliance. which includes a notification of non- (c) After issuance of a notification of compliance or a notice of denial of cer- noncompliance, the certifying agent tification, must treat the application must: as a new application and begin a new (1) Evaluate the applicant’s correc- application process pursuant to tive actions taken and supporting doc- § 205.402. umentation submitted or the written (g) Notwithstanding paragraph (a) of rebuttal, conduct an on-site inspection this section, if a certifying agent has if necessary, and reason to believe that an applicant for (i) When the corrective action or re- certification has willfully made a false buttal is sufficient for the applicant to statement or otherwise purposefully qualify for certification, issue the ap- misrepresented the applicant’s oper- plicant an approval of certification ation or its compliance with the cer- pursuant to § 205.404; or tification requirements pursuant to (ii) When the corrective action or re- this part, the certifying agent may buttal is not sufficient for the appli- deny certification pursuant to para- cant to qualify for certification, issue graph (c)(1)(ii) of this section without the applicant a written notice of denial first issuing a notification of non- of certification. compliance. (2) Issue a written notice of denial of certification to an applicant who fails § 205.406 Continuation of certification. to respond to the notification of non- (a) To continue certification, a cer- compliance. tified operation must annually pay the (3) Provide notice of approval or de- certification fees and submit the fol- nial to the Administrator, pursuant to lowing information, as applicable, to § 205.501(a)(14). the certifying agent: (d) A notice of denial of certification (1) An updated organic production or must state the reason(s) for denial and handling system plan which includes: the applicant’s right to: (i) A summary statement, supported (1) Reapply for certification pursuant by documentation, detailing any devi- to §§ 205.401 and 205.405(e); ations from, changes to, modifications (2) Request mediation pursuant to to, or other amendments made to the § 205.663 or, if applicable, pursuant to a previous year’s organic system plan State organic program; or during the previous year; and (3) File an appeal of the denial of cer- (ii) Any additions or deletions to the tification pursuant to § 205.681 or, if ap- previous year’s organic system plan, plicable, pursuant to a State organic intended to be undertaken in the com- program. ing year, detailed pursuant to § 205.200; (e) An applicant for certification who (2) Any additions to or deletions from has received a written notification of the information required pursuant to noncompliance or a written notice of § 205.401(b);
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(3) An update on the correction of §§ 205.407–205.499 [Reserved] minor noncompliances previously iden- tified by the certifying agent as requir- Subpart F—Accreditation of ing correction for continued certifi- Certifying Agents cation; and (4) Other information as deemed nec- § 205.500 Areas and duration of ac- essary by the certifying agent to deter- creditation. mine compliance with the Act and the (a) The Administrator shall accredit regulations in this part. a qualified domestic or foreign appli- (b) Following the receipt of the infor- cant in the areas of crops, livestock, mation specified in paragraph (a) of wild crops, or handling or any com- this section, the certifying agent shall bination thereof to certify a domestic within a reasonable time arrange and or foreign production or handling oper- conduct an on-site inspection of the ation as a certified operation. certified operation pursuant to (b) Accreditation shall be for a period § 205.403: Except, That, when it is impos- of 5 years from the date of approval of sible for the certifying agent to con- accreditation pursuant to § 205.506. duct the annual on-site inspection fol- (c) In lieu of accreditation under lowing receipt of the certified oper- paragraph (a) of this section, USDA ation’s annual update of information, will accept a foreign certifying agent’s the certifying agent may allow con- accreditation to certify organic pro- tinuation of certification and issue an duction or handling operations if: updated certificate of organic oper- (1) USDA determines, upon the re- ation on the basis of the information quest of a foreign government, that the submitted and the most recent on-site standards under which the foreign gov- inspection conducted during the pre- ernment authority accredited the for- vious 12 months: Provided, That, the eign certifying agent meet the require- annual on-site inspection, required pur- ments of this part; or suant to § 205.403, is conducted within (2) The foreign government authority the first 6 months following the cer- that accredited the foreign certifying tified operation’s scheduled date of an- agent acted under an equivalency nual update. agreement negotiated between the United States and the foreign govern- (c) If the certifying agent has reason ment. to believe, based on the on-site inspec- tion and a review of the information § 205.501 General requirements for ac- specified in § 205.404, that a certified op- creditation. eration is not complying with the re- (a) A private or governmental entity quirements of the Act and the regula- accredited as a certifying agent under tions in this part, the certifying agent this subpart must: shall provide a written notification of (1) Have sufficient expertise in or- noncompliance to the operation in ac- ganic production or handling tech- cordance with § 205.662. niques to fully comply with and imple- (d) If the certifying agent determines ment the terms and conditions of the that the certified operation is com- organic certification program estab- plying with the Act and the regula- lished under the Act and the regula- tions in this part and that any of the tions in this part; information specified on the certificate (2) Demonstrate the ability to fully of organic operation has changed, the comply with the requirements for ac- certifying agent must issue an updated creditation set forth in this subpart; certificate of organic operation pursu- (3) Carry out the provisions of the ant to § 205.404(b). Act and the regulations in this part,
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including the provisions of §§ 205.402 regulations in this part, except as pro- through 205.406 and § 205.670; vided for in § 205.504(b)(5); (4) Use a sufficient number of ade- (11) Prevent conflicts of interest by: quately trained personnel, including (i) Not certifying a production or inspectors and certification review per- handling operation if the certifying sonnel, to comply with and implement agent or a responsibly connected party the organic certification program es- of such certifying agent has or has held tablished under the Act and the regula- a commercial interest in the produc- tions in subpart E of this part; tion or handling operation, including (5) Ensure that its responsibly con- an immediate family interest or the nected persons, employees, and con- provision of consulting services, within tractors with inspection, analysis, and the 12-month period prior to the appli- decision-making responsibilities have cation for certification; sufficient expertise in organic produc- (ii) Excluding any person, including tion or handling techniques to success- contractors, with conflicts of interest fully perform the duties assigned. from work, discussions, and decisions (6) Conduct an annual performance in all stages of the certification proc- evaluation of all persons who review ess and the monitoring of certified pro- applications for certification, perform duction or handling operations for all on-site inspections, review certifi- entities in which such person has or has held a commercial interest, includ- cation documents, evaluate qualifica- ing an immediate family interest or tions for certification, make rec- the provision of consulting services, ommendations concerning certifi- within the 12-month period prior to the cation, or make certification decisions application for certification; and implement measures to correct (iii) Not permitting any employee, any deficiencies in certification serv- inspector, contractor, or other per- ices; sonnel to accept payment, gifts, or fa- (7) Have an annual program review of vors of any kind, other than prescribed its certification activities conducted fees, from any business inspected: Ex- by the certifying agent’s staff, an out- cept, That, a certifying agent that is a side auditor, or a consultant who has not-for-profit organization with an In- expertise to conduct such reviews and ternal Revenue Code tax exemption or, implement measures to correct any in the case of a foreign certifying noncompliances with the Act and the agent, a comparable recognition of not- regulations in this part that are identi- for-profit status from its government, fied in the evaluation; may accept voluntary labor from cer- (8) Provide sufficient information to tified operations; persons seeking certification to enable (iv) Not giving advice or providing them to comply with the applicable re- consultancy services, to certification quirements of the Act and the regula- applicants or certified operations, for tions in this part; overcoming identified barriers to cer- (9) Maintain all records pursuant to tification; § 205.510(b) and make all such records (v) Requiring all persons who review available for inspection and copying applications for certification, perform during normal business hours by au- on-site inspections, review certifi- thorized representatives of the Sec- cation documents, evaluate qualifica- retary and the applicable State organic tions for certification, make rec- program’s governing State official; ommendations concerning certifi- (10) Maintain strict confidentiality cation, or make certification decisions with respect to its clients under the ap- and all parties responsibly connected plicable organic certification program to the certifying agent to complete an and not disclose to third parties (with annual conflict of interest disclosure the exception of the Secretary or the report; and applicable State organic program’s (vi) Ensuring that the decision to governing State official or their au- certify an operation is made by a per- thorized representatives) any business- son different from those who conducted related information concerning any cli- the review of documents and on-site in- ent obtained while implementing the spection.
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(12)(i) Reconsider a certified oper- dling operation site inspected by the ation’s application for certification inspector and of any requirements for and, if necessary, perform a new on-site the correction of minor noncompli- inspection when it is determined, with- ances; in 12 months of certifying the oper- (19) Accept all production or handling ation, that any person participating in applications that fall within its area(s) the certification process and covered of accreditation and certify all quali- under § 205.501(a)(11)(ii) has or had a fied applicants, to the extent of its ad- conflict of interest involving the appli- ministrative capacity to do so without cant. All costs associated with a recon- regard to size or membership in any as- sideration of application, including on- sociation or group; and site inspection costs, shall be borne by (20) Demonstrate its ability to com- the certifying agent. ply with a State’s organic program to (ii) Refer a certified operation to a certify organic production or handling different accredited certifying agent operations within the State. for recertification and reimburse the (21) Comply with, implement, and operation for the cost of the recertifi- carry out any other terms and condi- cation when it is determined that any tions determined by the Administrator person covered under § 205.501(a)(11)(i) to be necessary. at the time of certification of the ap- (b) A private or governmental entity plicant had a conflict of interest in- accredited as a certifying agent under volving the applicant. this subpart may establish a seal, logo, (13) Accept the certification decisions or other identifying mark to be used by made by another certifying agent ac- production and handling operations credited or accepted by USDA pursuant certified by the certifying agent to in- to § 205.500; dicate affiliation with the certifying (14) Refrain from making false or agent: Provided, That, the certifying misleading claims about its accredita- agent: tion status, the USDA accreditation (1) Does not require use of its seal, program for certifying agents, or the logo, or other identifying mark on any nature or qualities of products labeled product sold, labeled, or represented as as organically produced; organically produced as a condition of (15) Submit to the Administrator a certification and copy of: (2) Does not require compliance with (i) Any notice of denial of certifi- any production or handling practices cation issued pursuant to § 205.405, noti- other than those provided for in the fication of noncompliance, notification Act and the regulations in this part as of noncompliance correction, notifica- a condition of use of its identifying tion of proposed suspension or revoca- mark: Provided, That, certifying agents tion, and notification of suspension or certifying production or handling oper- revocation sent pursuant to § 205.662 si- ations within a State with more re- multaneously with its issuance; and strictive requirements, approved by the (ii) A list, on January 2 of each year, Secretary, shall require compliance including the name, address, and tele- with such requirements as a condition phone number of each operation grant- of use of their identifying mark by ed certification during the preceding such operations. year; (c) A private entity accredited as a (16) Charge applicants for certifi- certifying agent must: cation and certified production and (1) Hold the Secretary harmless for handling operations only those fees and any failure on the part of the certi- charges for certification activities that fying agent to carry out the provisions it has filed with the Administrator; of the Act and the regulations in this (17) Pay and submit fees to AMS in part; accordance with § 205.640; (2) Furnish reasonable security, in an (18) Provide the inspector, prior to amount and according to such terms as each on-site inspection, with previous the Administrator may by regulation on-site inspection reports and notify prescribe, for the purpose of protecting the inspector of its decision regarding the rights of production and handling certification of the production or han- operations certified by such certifying
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agent under the Act and the regula- phone, facsimile, and Internet address) tions in this part; and for each of its organizational units, (3) Transfer to the Administrator and such as chapters or subsidiary offices, make available to any applicable State and the name of a contact person for organic program’s governing State offi- each unit; cial all records or copies of records (c) Each area of operation (crops, concerning the person’s certification wild crops, livestock, or handling) for activities in the event that the certi- which accreditation is requested and fying agent dissolves or loses its ac- the estimated number of each type of creditation; Provided, That, such trans- operation anticipated to be certified fer shall not apply to a merger, sale, or annually by the applicant along with a other transfer of ownership of a certi- fying agent. copy of the applicant’s schedule of fees (d) No private or governmental enti- for all services to be provided under ty accredited as a certifying agent these regulations by the applicant; under this subpart shall exclude from (d) The type of entity the applicant is participation in or deny the benefits of (e.g., government agricultural office, the National Organic Program to any for-profit business, not-for-profit mem- person due to discrimination because of bership association) and for: race, color, national origin, gender, re- (1) A governmental entity, a copy of ligion, age, disability, political beliefs, the official’s authority to conduct cer- sexual orientation, or marital or fam- tification activities under the Act and ily status. the regulations in this part, (2) A private entity, documentation § 205.502 Applying for accreditation. showing the entity’s status and organi- (a) A private or governmental entity zational purpose, such as articles of in- seeking accreditation as a certifying corporation and by-laws or ownership agent under this subpart must submit or membership provisions, and its date an application for accreditation which of establishment; and contains the applicable information (e) A list of each State or foreign and documents set forth in §§ 205.503 country in which the applicant cur- through 205.505 and the fees required in rently certifies production and han- § 205.640 to: Program Manager, USDA– AMS–TMP–NOP, Room 2945—South dling operations and a list of each Building, P.O. Box 96456, Washington, State or foreign country in which the DC 20090–6456. applicant intends to certify production (b) Following the receipt of the infor- or handling operations. mation and documents, the Adminis- trator will determine, pursuant to § 205.504 Evidence of expertise and § 205.506, whether the applicant for ac- ability. creditation should be accredited as a A private or governmental entity certifying agent. seeking accreditation as a certifying agent must submit the following docu- § 205.503 Applicant information. ments and information to demonstrate A private or governmental entity its expertise in organic production or seeking accreditation as a certifying handling techniques; its ability to fully agent must submit the following infor- comply with and implement the or- mation: ganic certification program established (a) The business name, primary office in §§ 205.100 and 205.101, §§ 205.201 location, mailing address, name of the through 205.203, §§ 205.300 through person(s) responsible for the certifying 205.303, §§ 205.400 through 205.406, and agent’s day-to-day operations, contact §§ 205.661 and 205.662; and its ability to numbers (telephone, facsimile, and comply with the requirements for ac- Internet address) of the applicant, and, creditation set forth in § 205.501: for an applicant who is a private per- son, the entity’s taxpayer identifica- (a) Personnel. (1) A copy of the appli- tion number; cant’s policies and procedures for (b) The name, office location, mailing training, evaluating, and supervising address, and contact numbers (tele- personnel;
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(2) The name and position description (iii) The results of laboratory anal- of all personnel to be used in the cer- yses for residues of pesticides and other tification operation, including admin- prohibited substances conducted during istrative staff, certification inspectors, the current and 3 preceding calender members of any certification review years; and and evaluation committees, contrac- (iv) Other business information as tors, and all parties responsibly con- permitted in writing by the producer or nected to the certifying agent; handler; and (3) A description of the qualifica- (6) A copy of the procedures to be tions, including experience, training, used for sampling and residue testing and education in agriculture, organic pursuant to § 205.670. production, and organic handling, for: (c) Conflicts of interest. (1) A copy of (i) Each inspector to be used by the procedures intended to be implemented applicant and to prevent the occurrence of conflicts (ii) Each person to be designated by of interest, as described in the applicant to review or evaluate ap- § 205.501(a)(11). plications for certification; and (2) For all persons who review appli- (4) A description of any training that cations for certification, perform on- the applicant has provided or intends site inspections, review certification to provide to personnel to ensure that documents, evaluate qualifications for they comply with and implement the certification, make recommendations requirements of the Act and the regu- concerning certification, or make cer- lations in this part. tification decisions and all parties re- sponsibly connected to the certifying (b) Administrative policies and proce- agent, a conflict of interest disclosure dures. (1) A copy of the procedures to be report, identifying any food- or agri- used to evaluate certification appli- culture-related business interests, in- cants, make certification decisions, cluding business interests of imme- and issue certification certificates; diate family members, that cause a (2) A copy of the procedures to be conflict of interest. used for reviewing and investigating (d) Current certification activities. An certified operation compliance with applicant who currently certifies pro- the Act and the regulations in this part duction or handling operations must and the reporting of violations of the submit: (1) A list of all production and Act and the regulations in this part to handling operations currently certified the Administrator; by the applicant; (3) A copy of the procedures to be (2) Copies of at least 3 different in- used for complying with the record- spection reports and certification eval- keeping requirements set forth in uation documents for production or § 205.501(a)(9); handling operations certified by the ap- (4) A copy of the procedures to be plicant during the previous year for used for maintaining the confiden- each area of operation for which ac- tiality of any business-related informa- creditation is requested; and tion as set forth in § 205.501(a)(10); (3) The results of any accreditation (5) A copy of the procedures to be process of the applicant’s operation by used, including any fees to be assessed, an accrediting body during the pre- for making the following information vious year for the purpose of evalu- available to any member of the public ating its certification activities. upon request: (e) Other information. Any other infor- (i) Certification certificates issued mation the applicant believes may as- during the current and 3 preceding cal- sist in the Administrator’s evaluation ender years; of the applicant’s expertise and ability. (ii) A list of producers and handlers whose operations it has certified, in- § 205.505 Statement of agreement. cluding for each the name of the oper- (a) A private or governmental entity ation, type(s) of operation, products seeking accreditation under this sub- produced, and the effective date of the part must sign and return a statement certification, during the current and 3 of agreement prepared by the Adminis- preceding calender years; trator which affirms that, if granted
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accreditation as a certifying agent concerning the certifying agent’s cer- under this subpart, the applicant will tification activities in the event that carry out the provisions of the Act and the certifying agent dissolves or loses the regulations in this part, including: its accreditation; Provided, That such (1) Accept the certification decisions transfer shall not apply to a merger, made by another certifying agent ac- sale, or other transfer of ownership of a credited or accepted by USDA pursuant certifying agent. to § 205.500; (2) Refrain from making false or mis- § 205.506 Granting accreditation. leading claims about its accreditation (a) Accreditation will be granted status, the USDA accreditation pro- when: gram for certifying agents, or the na- (1) The accreditation applicant has ture or qualities of products labeled as submitted the information required by organically produced; §§ 205.503 through 205.505; (3) Conduct an annual performance (2) The accreditation applicant pays evaluation of all persons who review the required fee in accordance with applications for certification, perform § 205.640(c); and on-site inspections, review certifi- (3) The Administrator determines cation documents, evaluate qualifica- that the applicant for accreditation tions for certification, make rec- meets the requirements for accredita- ommendations concerning certifi- tion as stated in § 205.501, as deter- cation, or make certification decisions mined by a review of the information and implement measures to correct submitted in accordance with §§ 205.503 any deficiencies in certification serv- through 205.505 and, if necessary, a re- ices; view of the information obtained from (4) Have an annual internal program a site evaluation as provided for in review conducted of its certification § 205.508. activities by certifying agent staff, an (b) On making a determination to ap- outside auditor, or a consultant who prove an application for accreditation, has the expertise to conduct such re- the Administrator will notify the ap- views and implement measures to cor- plicant of the granting of accreditation rect any noncompliances with the Act in writing, stating: and the regulations in this part; (5) Pay and submit fees to AMS in ac- (1) The area(s) for which accredita- cordance with § 205.640; and tion is given; (6) Comply with, implement, and (2) The effective date of the accredi- carry out any other terms and condi- tation; tions determined by the Administrator (3) Any terms and conditions for the to be necessary. correction of minor noncompliances; (b) A private entity seeking accredi- and tation as a certifying agent under this (4) For a certifying agent who is a subpart must additionally agree to: private entity, the amount and type of (1) Hold the Secretary harmless for security that must be established to any failure on the part of the certi- protect the rights of production and fying agent to carry out the provisions handling operations certified by such of the Act and the regulations in this certifying agent. part; (c) The accreditation of a certifying (2) Furnish reasonable security, in an agent shall continue in effect until amount and according to such terms as such time as the certifying agent fails the Administrator may by regulation to renew accreditation as provided in prescribe, for the purpose of protecting § 205.510(c), the certifying agent volun- the rights of production and handling tarily ceases its certification activi- operations certified by such certifying ties, or accreditation is suspended or agent under the Act and the regula- revoked pursuant to § 205.665. tions in this part; and (3) Transfer to the Administrator and § 205.507 Denial of accreditation. make available to the applicable State (a) If the Program Manager has rea- organic program’s governing State offi- son to believe, based on a review of the cial all records or copies of records information specified in §§ 205.503
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through 205.505 or after a site evalua- companied by evidence demonstrating tion as specified in § 205.508, that an ap- correction of each noncompliance and plicant for accreditation is not able to corrective actions taken to comply comply or is not in compliance with with and remain in compliance with the requirements of the Act and the the Act and the regulations in this regulations in this part, the Program part. A certifying agent whose accredi- Manager shall provide a written notifi- tation is revoked will be ineligible for cation of noncompliance to the appli- accreditation for a period of not less cant. Such notification shall provide: than 3 years following the date of such (1) A description of each noncompli- determination. ance; (2) The facts upon which the notifica- § 205.508 Site evaluations. tion of noncompliance is based; and (3) The date by which the applicant (a) Site evaluations of accredited cer- must rebut or correct each noncompli- tifying agents shall be conducted for ance and submit supporting docu- the purpose of examining the certifying mentation of each such correction agent’s operations and evaluating its when correction is possible. compliance with the Act and the regu- (b) When each noncompliance has lations of this part. Site evaluations been resolved, the Program Manager shall include an on-site review of the will send the applicant a written notifi- certifying agent’s certification proce- cation of noncompliance resolution and dures, decisions, facilities, administra- proceed with further processing of the tive and management systems, and application. production or handling operations cer- (c) If an applicant fails to correct the tified by the certifying agent. Site noncompliances, fails to report the cor- rections by the date specified in the no- evaluations shall be conducted by a tification of noncompliance, fails to representative(s) of the Administrator. file a rebuttal of the notification of (b) An initial site evaluation of an noncompliance by the date specified, or accreditation applicant shall be con- is unsuccessful in its rebuttal, the Pro- ducted before or within a reasonable gram Manager will provide the appli- period of time after issuance of the ap- cant with written notification of ac- plicant’s ‘‘notification of accredita- creditation denial. An applicant who tion.’’ A site evaluation shall be con- has received written notification of ac- ducted after application for renewal of creditation denial may apply for ac- accreditation but prior to the issuance creditation again at any time in ac- of a notice of renewal of accreditation. cordance with § 205.502, or appeal the One or more site evaluations will be denial of accreditation in accordance conducted during the period of accredi- with § 205.681 by the date specified in tation to determine whether an accred- the notification of accreditation de- ited certifying agent is complying with nial. the general requirements set forth in (d) If the certifying agent was accred- § 205.501. ited prior to the site evaluation and the certifying agent fails to correct the § 205.509 Peer review panel. noncompliances, fails to report the cor- rections by the date specified in the no- The Administrator shall establish a tification of noncompliance, or fails to peer review panel pursuant to the Fed- file a rebuttal of the notification of eral Advisory Committee Act (FACA) noncompliance by the date specified, (5 U.S.C. App. 2 et seq.). The peer re- the Administrator will begin pro- view panel shall be composed of not ceedings to suspend or revoke the cer- less than 3 members who shall annu- tifying agent’s accreditation. A certi- ally evaluate the National Organic fying agent who has had its accredita- Program’s adherence to the accredita- tion suspended may at any time, unless tion procedures in this subpart F and otherwise stated in the notification of ISO/IEC Guide 61, General require- suspension, submit a request to the ments for assessment and accreditation Secretary for reinstatement of its ac- of certification/registration bodies, and creditation. The request must be ac-
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the National Organic Program’s ac- part F, excluding any records covered creditation decisions. This shall be ac- by §§ 205.510(b)(2), must be maintained complished through the review of ac- for not less than 5 years beyond their creditation procedures, document re- creation or receipt. view and site evaluation reports, and (c) Renewal of accreditation. (1) The accreditation decision documents or Administrator shall send the accred- documentation. The peer review panel ited certifying agent a notice of pend- shall report its finding, in writing, to ing expiration of accreditation approxi- the National Organic Program’s Pro- mately 1 year prior to the scheduled gram Manager. date of expiration. (2) An accredited certifying agent’s § 205.510 Annual report, record- application for accreditation renewal keeping, and renewal of accredita- tion. must be received at least 6 months prior to the fifth anniversary of (a) Annual report and fees. An accred- issuance of the notification of accredi- ited certifying agent must submit an- tation and each subsequent renewal of nually to the Administrator, on or be- accreditation. The accreditation of cer- fore the anniversary date of the tifying agents who make timely appli- issuance of the notification of accredi- cation for renewal of accreditation will tation, the following reports and fees: not expire during the renewal process. (1) A complete and accurate update of The accreditation of certifying agents information submitted pursuant to who fail to make timely application for §§ 205.503 and 205.504; renewal of accreditation will expire as (2) Information supporting any scheduled unless renewed prior to the changes being requested in the areas of scheduled expiration date. Certifying accreditation described in § 205.500; agents with an expired accreditation (3) A description of the measures im- must not perform certification activi- plemented in the previous year and any ties under the Act and the regulations measures to be implemented in the of this part. coming year to satisfy any terms and conditions determined by the Adminis- (3) Following receipt of the informa- trator to be necessary, as specified in tion submitted by the certifying agent the most recent notification of accredi- in accordance with paragraph (a) of tation or notice of renewal of accredi- this section and the results of a site tation; evaluation, the Administrator will de- (4) The results of the most recent termine whether the certifying agent performance evaluations and annual remains in compliance with the Act program review and a description of ad- and the regulations of this part and justments to the certifying agent’s op- should have its accreditation renewed. eration and procedures implemented or (d) Notice of renewal of accreditation. to be implemented in response to the Upon a determination that the certi- performance evaluations and program fying agent is in compliance with the review; and Act and the regulations of this part, (5) The fees required in § 205.640(a). the Administrator will issue a notice of (b) Recordkeeping. Certifying agents renewal of accreditation. The notice of must maintain records according to renewal will specify any terms and con- the following schedule: ditions that must be addressed by the (1) Records obtained from applicants certifying agent and the time within for certification and certified oper- which those terms and conditions must ations must be maintained for not less be satisfied. than 5 years beyond their receipt; (e) Noncompliance. Upon a determina- (2) Records created by the certifying tion that the certifying agent is not in agent regarding applicants for certifi- compliance with the Act and the regu- cation and certified operations must be lations of this part, the Administrator maintained for not less than 10 years will initiate proceedings to suspend or beyond their creation; and revoke the certifying agent’s accredi- (3) Records created or received by the tation. certifying agent pursuant to the ac- (f) Amending accreditation. Amend- creditation requirements of this sub- ment to scope of an accreditation may
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be requested at any time. The applica- good manufacturing practices (GMP) tion for amendment shall be sent to and contains no residues of heavy met- the Administrator and shall contain in- als or other contaminants in excess of formation applicable to the requested tolerances set by FDA; and change in accreditation, a complete (6) The substance is essential for the and accurate update of the information handling of organically produced agri- submitted pursuant to §§ 205.503 and cultural products. 205.504, and the applicable fees required (c) Nonsynthetics used in organic in § 205.640. processing will be evaluated using the criteria specified in the Act (7 U.S.C. §§ 205.511–205.599 [Reserved] 6517 and 6518).
Subpart G—Administrative § 205.601 Synthetic substances allowed for use in organic crop production. THE NATIONAL LIST OF ALLOWED AND In accordance with restrictions speci- PROHIBITED SUBSTANCES fied in this section, the following syn- § 205.600 Evaluation criteria for al- thetic substances may be used in or- lowed and prohibited substances, ganic crop production: methods, and ingredients. (a) As algicide, disinfectants, and The following criteria will be utilized sanitizer, including irrigation system in the evaluation of substances or in- cleaning systems. gredients for the organic production (1) Alcohols. and handling sections of the National (i) Ethanol. List: (ii) Isopropanol. (a) Synthetic and nonsynthetic sub- (2) Chlorine materials—Except, That, stances considered for inclusion on or residual chlorine levels in the water deletion from the National List of al- shall not exceed the maximum residual lowed and prohibited substances will be disinfectant limit under the Safe evaluated using the criteria specified Drinking Water Act. in the Act (7 U.S.C. 6517 and 6518). (i) Calcium hypochlorite. (b) In addition to the criteria set (ii) Chlorine dioxide. forth in the Act, any synthetic sub- (iii) Sodium hypochlorite. stance used as a processing aid or adju- (3) Hydrogen peroxide. vant will be evaluated against the fol- (4) Soap-based algicide/demisters. lowing criteria: (b) As herbicides, weed barriers, as (1) The substance cannot be produced applicable. from a natural source and there are no (1) Herbicides, soap-based—for use in organic substitutes; farmstead maintenance (roadways, (2) The substance’s manufacture, use, ditches, right of ways, building perim- and disposal do not have adverse ef- eters) and ornamental crops. fects on the environment and are done in a manner compatible with organic (2) Mulches. handling; (i) Newspaper or other recycled (3) The nutritional quality of the paper, without glossy or colored inks. food is maintained when the substance (ii) Plastic mulch and covers (petro- is used, and the substance, itself, or its leum-based other than polyvinyl chlo- breakdown products do not have an ad- ride (PVC)). verse effect on human health as defined (c) As compost feedstocks—News- by applicable Federal regulations; papers or other recycled paper, without (4) The substance’s primary use is glossy or colored inks. not as a preservative or to recreate or (d) As animal repellents—Soaps, am- improve flavors, colors, textures, or monium—for use as a large animal re- nutritive value lost during processing, pellant only, no contact with soil or except where the replacement of nutri- edible portion of crop. ents is required by law; (e) As insecticides (including (5) The substance is listed as gen- acaricides or mite control). erally recognized as safe (GRAS) by (1) Ammonium carbonate—for use as Food and Drug Administration (FDA) bait in insect traps only, no direct con- when used in accordance with FDA’s tact with crop or soil.
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(2) Boric acid—structural pest con- (6) Micronutrients—not to be used as trol, no direct contact with organic a defoliant, herbicide, or desiccant. food or crops. Those made from nitrates or chlorides (3) Elemental sulfur. are not allowed. Soil deficiency must (4) Lime sulfur—including calcium be documented by testing. polysulfide. (i) Soluble boron products. (5) Oils, horticultural—narrow range (ii) Sulfates, carbonates, oxides, or oils as dormant, suffocating, and sum- silicates of zinc, copper, iron, man- mer oils. ganese, molybdenum, selenium, and co- (6) Soaps, insecticidal. balt. (7) Sticky traps/barriers. (f) As insect attractants— (7) Liquid fish products—can be pH Pheromones. adjusted with sulfuric, citric or phos- (g) As rodenticides. phoric acid. The amount of acid used (1) Sulfur dioxide—underground ro- shall not exceed the minimum needed dent control only (smoke bombs). to lower the pH to 3.5. (2) Vitamin D3. (8) Vitamins, B1, C, and E. (h) As slug or snail bait—None. (k) As plant growth regulators— (i) As plant disease control. Ethylene—for regulation of pineapple (1) Coppers, fixed—copper hydroxide, flowering. copper oxide, copper oxychloride, in- (l) As floating agents in postharvest cludes products exempted from EPA handling. tolerance, Provided, That, copper-based (1) Lignin sulfonate. materials must be used in a manner (2) Sodium silicate—for tree fruit and that minimizes accumulation in the fiber processing. soil and shall not be used as herbicides. (m) As synthetic inert ingredients as (2) Copper sulfate—Substance must classified by the Environmental Pro- be used in a manner that minimizes ac- tection Agency (EPA), for use with cumulation of copper in the soil. nonsynthetic substances or synthetic (3) Hydrated lime—must be used in a substances listed in this section and manner that minimizes copper accu- mulation in the soil. used as an active pesticide ingredient (4) Hydrogen peroxide. in accordance with any limitations on (5) Lime sulfur. the use of such substances. (6) Oils, horticultural, narrow range (1) EPA List 4—Inerts of Minimal oils as dormant, suffocating, and sum- Concern. mer oils. (n)–(z) [Reserved] (7) Potassium bicarbonate. (8) Elemental sulfur. § 205.602 Nonsynthetic substances pro- (9) Streptomycin, for fire blight con- hibited for use in organic crop pro- trol in apples and pears only. duction. (10) Tetracycline (oxytetracycline The following nonsynthetic sub- calcium complex), for fire blight con- stances may not be used in organic trol only. crop production: (j) As plant or soil amendments. (a) Ash from manure burning. (1) Aquatic plant extracts (other than (b) Arsenic. hydrolyzed)—Extraction process is lim- (c) Lead salts. ited to the use of potassium hydroxide (d) Sodium fluoaluminate (mined). or sodium hydroxide; solvent amount (e) Strychnine. used is limited to that amount nec- essary for extraction. (f) Tobacco dust (nicotine sulfate). (2) Elemental sulfur. (g) Potassium chloride—unless de- (3) Humic acids—naturally occurring rived from a mined source and applied deposits, water and alkali extracts in a manner that minimizes chloride only. accumulation in the soil. (4) Lignin sulfonate—chelating agent, (h) Sodium nitrate—unless use is re- dust suppressant, floatation agent. stricted to no more than 20% of the (5) Magnesium sulfate—allowed with crop’s total nitrogen requirement. a documented soil deficiency. (i)–(z) [Reserved]
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§ 205.603 Synthetic substances allowed direct contact with organically man- for use in organic livestock produc- aged livestock or land occurs. tion. (14) Biologics—Vaccines. In accordance with restrictions speci- (b) As topical treatment, external fied in this section the following syn- parasiticide or local anesthetic as ap- thetic substances may be used in or- plicable. ganic livestock production: (1) Iodine. (a) As disinfectants, sanitizer, and (2) Lidocaine—as a local anesthetic. medical treatments as applicable. Use requires a withdrawal period of 90 (1) Alcohols. days after administering to livestock (i) Ethanol—disinfectant and sani- intended for slaughter and 7 days after tizer only, prohibited as a feed addi- administering to dairy animals. tive. (3) Lime, hydrated—(bordeaux (ii) Isopropanol—disinfectant only. mixes), not permitted to cauterize (2) Aspirin—approved for health care physical alterations or deodorize ani- use to reduce inflammation mal wastes. (3) Chlorine materials—disinfecting (4) Mineral oil—for topical use and as and sanitizing facilities and equip- a lubricant. ment. Residual chlorine levels in the water shall not exceed the maximum (5) Procaine—as a local anesthetic, residual disinfectant limit under the use requires a withdrawal period of 90 Safe Drinking Water Act. days after administering to livestock (i) Calcium hypochlorite. intended for slaughter and 7 days after (ii) Chlorine dioxide. administering to dairy animals. (iii) Sodium hypochlorite. (6) Copper sulfate. (4) Chlorohexidine—Allowed for sur- (c) As feed supplements—Milk replac- gical procedures conducted by a veteri- ers without antibiotics, as emergency narian. Allowed for use as a teat dip use only, no nonmilk products or prod- when alternative germicidal agents ucts from BST treated animals. and/or physical barriers have lost their (d) As feed additives. effectiveness. (1) Trace minerals, used for enrich- (5) Electrolytes—without antibiotics. ment or fortification when FDA ap- (6) Glucose. proved, including: (7) Glycerin—Allowed as a livestock (i) Copper sulfate. teat dip, must be produced through the (ii) Magnesium sulfate. hydrolysis of fats or oils. (2) Vitamins, used for enrichment or (8) Iodine. fortification when FDA approved. (9) Hydrogen peroxide. (e) As synthetic inert ingredients as (10) Magnesium sulfate. classified by the Environmental Pro- (11) Oxytocin—use in postparturition tection Agency (EPA), for use with therapeutic applications. nonsynthetic substances or a synthetic (12) Parasiticides—Ivermectin—pro- substances listed in this section and hibited in slaughter stock, allowed in used as an active pesticide ingredient emergency treatment for dairy and in accordance with any limitations on breeder stock when organic system the use of such substances. plan-approved preventive management (f) EPA List 4—Inerts of Minimal does not prevent infestation. Milk or milk products from a treated animal Concern. cannot be labeled as provided for in (g)–(z) [Reserved] subpart D of this part for 90 days fol- lowing treatment. In breeder stock, § 205.604 Nonsynthetic substances pro- hibited for use in organic livestock treatment cannot occur during the last production. third of gestation if the progeny will be sold as organic and must not be used The following nonsynthetic sub- during the lactation period of breeding stances may not be used in organic stock. livestock production: (13) Phosphoric acid—allowed as an (a) Strychnine. equipment cleaner, Provided, That, no (b)–(z) [Reserved]
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§ 205.605 Nonagricultural (nonorganic) (3) Ammonium carbonate—for use substances allowed as ingredients only as a leavening agent. in or on processed products labeled (4) Ascorbic acid. as ‘‘organic’’ or ‘‘made with organic (5) Calcium citrate. (specified ingredients or food (6) Calcium hydroxide. group(s)).’’ (7) Calcium phosphates (monobasic, The following nonagricultural sub- dibasic, and tribasic). stances may be used as ingredients in (8) Carbon dioxide. or on processed products labeled as (9) Chlorine materials—disinfecting ‘‘organic’’ or ‘‘made with organic (spec- and sanitizing food contact surfaces, ified ingredients or food group(s))’’ Except, That, residual chlorine levels in only in accordance with any restric- the water shall not exceed the max- tions specified in this section. imum residual disinfectant limit under (a) Nonsynthetics allowed: the Safe Drinking Water Act. (1) Acids. (i) Calcium hypochlorite. (i) Alginic. (ii) Chlorine dioxide. (ii) Citric—produced by microbial fer- (iii) Sodium hypochlorite. mentation of carbohydrate substances. (10) Ethylene—allowed for (iii) Lactic. postharvest ripening of tropical fruit. (2) Bentonite. (11) Ferrous sulfate—for iron enrich- (3) Calcium carbonate. ment or fortification of foods when re- (4) Calcium chloride. quired by regulation or recommended (5) Colors, nonsynthetic sources only. (independent organization). (6) Dairy cultures. (12) Glycerides (mono and di)—for use (7) Diatomaceous earth—food fil- only in drum drying of food. tering aid only. (13) Glycerin—produced by hydrolysis (8) Enzymes—must be derived from of fats and oils. edible, nontoxic plants, nonpathogenic (14) Hydrogen peroxide. fungi, or nonpathogenic bacteria. (15) Lecithin—bleached. (9) Flavors, nonsynthetic sources (16) Magnesium carbonate—for use only and must not be produced using only in agricultural products labeled synthetic solvents and carrier systems ‘‘made with organic (specified ingredi- or any artificial preservative. (10) Kaolin. ents or food group(s)),’’ prohibited in (11) Magnesium sulfate, nonsynthetic agricultural products labeled ‘‘or- sources only. ganic’’. (12) Nitrogen—oil-free grades. (17) Magnesium chloride—derived (13) Oxygen—oil-free grades. from sea water. (14) Perlite—for use only as a filter (18) Magnesium stearate—for use aid in food processing. only in agricultural products labeled (15) Potassium chloride. ‘‘made with organic (specified ingredi- (16) Potassium iodide. ents or food group(s)),’’ prohibited in (17) Sodium bicarbonate. agricultural products labeled ‘‘or- (18) Sodium carbonate. ganic’’. (19) Waxes—nonsynthetic. (19) Nutrient vitamins and minerals, (i) Carnauba wax. in accordance with 21 CFR 104.20, Nu- (ii) Wood resin. tritional Quality Guidelines For Foods. (20) Yeast—nonsynthetic, growth on (20) Ozone. petrochemical substrate and sulfite (21) Pectin (low-methoxy). waste liquor is prohibited. (22) Phosphoric acid—cleaning of (i) Autolysate. food-contact surfaces and equipment (ii) Bakers. only. (iii) Brewers. (23) Potassium acid tartrate. (iv) Nutritional. (24) Potassium tartrate made from (v) Smoked—nonsynthetic smoke fla- tartaric acid. voring process must be documented. (25) Potassium carbonate. (b) Synthetics allowed: (26) Potassium citrate. (1) Alginates. (27) Potassium hydroxide—prohibited (2) Ammonium bicarbonate—for use for use in lye peeling of fruits and vege- only as a leavening agent. tables.
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(28) Potassium iodide—for use only in ated by the Board for recommendation agricultural products labeled ‘‘made to the Secretary for inclusion on or de- with organic (specified ingredients or letion from the National List in ac- food group(s)),’’ prohibited in agricul- cordance with the Act. tural products labeled ‘‘organic’’. (b) A person petitioning for amend- (29) Potassium phosphate—for use ment of the National List should re- only in agricultural products labeled quest a copy of the petition procedures ‘‘made with organic (specific ingredi- from the USDA at the address in ents or food group(s)),’’ prohibited in § 205.607(c). agricultural products labeled ‘‘or- (c) A petition to amend the National ganic’’. List must be submitted to: Program (30) Silicon dioxide. Manager, USDA/AMS/TMP/NOP, Room (31) Sodium citrate. 2945, South Building, P.O. Box 96456, (32) Sodium hydroxide—prohibited Washington, DC 20090–6456. for use in lye peeling of fruits and vege- tables. §§ 205.608–205.619 [Reserved] (33) Sodium phosphates—for use only in dairy foods. STATE ORGANIC PROGRAMS (34) Sulfur dioxide—for use only in § 205.620 Requirements of State or- wine labeled ‘‘made with organic ganic programs. grapes,’’ Provided, That, total sulfite concentration does not exceed 100 ppm. (a) A State may establish a State or- (35) Tocopherols—derived from vege- ganic program for production and han- table oil when rosemary extracts are dling operations within the State not a suitable alternative. which produce and handle organic agri- (36) Xanthan gum. cultural products. (c)-(z) [Reserved] (b) A State organic program must meet the requirements for organic pro- § 205.606 Nonorganically produced ag- grams specified in the Act. ricultural products allowed as in- (c) A State organic program may gredients in or on processed prod- contain more restrictive requirements ucts labeled as ‘‘organic’’ or ‘‘made because of environmental conditions or with organic (specified ingredients the necessity of specific production or or food group(s)).’’ handling practices particular to the The following nonorganically pro- State or region of the United States. duced agricultural products may be (d) A State organic program must as- used as ingredients in or on processed sume enforcement obligations in the products labeled as ‘‘organic’’ or ‘‘made State for the requirements of this part with organic (specified ingredients or and any more restrictive requirements food group(s))’’ only in accordance with approved by the Secretary. any restrictions specified in this sec- (e) A State organic program and any tion. amendments to such program must be Any nonorganically produced agri- approved by the Secretary prior to cultural product may be used in ac- being implemented by the State. cordance with the restrictions specified in this section and when the product is § 205.621 Submission and determina- not commercially available in organic tion of proposed State organic pro- form. grams and amendments to ap- (a) Cornstarch (native) proved State organic programs. (b) Gums—water extracted only (ara- (a) A State organic program’s gov- bic, guar, locust bean, carob bean) erning State official must submit to (c) Kelp—for use only as a thickener the Secretary a proposed State organic and dietary supplement program and any proposed amendments (d) Lecithin—unbleached to such approved program. (e) Pectin (high-methoxy) (1) Such submission must contain supporting materials that include stat- § 205.607 Amending the National List. utory authorities, program description, (a) Any person may petition the Na- documentation of the environmental tional Organic Standard Board for the conditions or specific production and purpose of having a substance evalu- handling practices particular to the
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State which necessitate more restric- certifying agents submitting annual re- tive requirements than the require- ports or seeking renewal of accredita- ments of this part, and other informa- tion in accordance with the following tion as may be required by the Sec- provisions: retary. (a) Fees-for-service. (1) Except as oth- (2) Submission of a request for erwise provided in this section, fees- amendment of an approved State or- for-service shall be based on the time ganic program must contain sup- required to render the service provided porting materials that include an ex- calculated to the nearest 15-minute pe- planation and documentation of the en- riod, including the review of applica- vironmental conditions or specific pro- tions and accompanying documents duction and handling practices par- and information, evaluator travel, the ticular to the State or region, which conduct of on-site evaluations, review necessitates the proposed amendment. of annual reports and updated docu- Supporting material also must explain ments and information, and the time how the proposed amendment furthers required to prepare reports and any and is consistent with the purposes of other documents in connection with the Act and the regulations of this the performance of service. The hourly part. rate shall be the same as that charged (b) Within 6 months of receipt of sub- by the Agricultural Marketing Service, mission, the Secretary will: Notify the through its Quality Systems Certifi- State organic program’s governing cation Program, to certification bodies State official of approval or dis- requesting conformity assessment to approval of the proposed program or the International Organization for amendment of an approved program Standardization ‘‘General Require- and, if disapproved, the reasons for the ments for Bodies Operating Product disapproval. Certification Systems’’ (ISO Guide 65). (c) After receipt of a notice of dis- (2) Applicants for initial accredita- approval, the State organic program’s tion and accredited certifying agents governing State official may submit a submitting annual reports or seeking revised State organic program or renewal of accreditation during the amendment of such a program at any first 18 months following the effective time. date of subpart F of this part shall re- § 205.622 Review of approved State or- ceive service without incurring an ganic programs. hourly charge for service. (3) Applicants for initial accredita- The Secretary will review a State or- tion and renewal of accreditation must ganic program not less than once dur- pay at the time of application, effec- ing each 5-year period following the tive 18 months following February 20, date of the initial program approval. 2001, a nonrefundable fee of $500.00 The Secretary will notify the State or- which shall be applied to the appli- ganic program’s governing State offi- cant’s fees-for-service account. cial of approval or disapproval of the (b) Travel charges. When service is program within 6 months after initi- requested at a place so distant from ation of the review. the evaluator’s headquarters that a §§ 205.623–205.639 [Reserved] total of one-half hour or more is re- quired for the evaluator(s) to travel to FEES such place and back to the head- quarters or at a place of prior assign- § 205.640 Fees and other charges for ment on circuitous routing requiring a accreditation. total of one-half hour or more to travel Fees and other charges equal as near- to the next place of assignment on the ly as may be to the cost of the accredi- circuitous routing, the charge for such tation services rendered under the reg- service shall include a mileage charge ulations, including initial accredita- administratively determined by the tion, review of annual reports, and re- U.S. Department of Agriculture and newal of accreditation, shall be as- travel tolls, if applicable, or such trav- sessed and collected from applicants el prorated among all the applicants for initial accreditation and accredited and certifying agents furnished the
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service involved on an equitable basis cation. Remittance must be made pay- or, when the travel is made by public able to the Agricultural Marketing transportation (including hired vehi- Service, USDA, and mailed to: Pro- cles), a fee equal to the actual cost gram Manager, USDA–AMS–TMP–NOP, thereof. Travel charges shall become Room 2945-South Building, P.O. Box effective for all applicants for initial 96456, Washington, DC 20090–6456 or accreditation and accredited certifying such other address as required by the agents on February 20, 2001. The appli- Program Manager. cant or certifying agent will not be (b) Payments for fees and other charged a new mileage rate without no- charges not covered under paragraph tification before the service is ren- (a) of this section must be: dered. (1) Received by the due date shown (c) Per diem charges. When service is on the bill for collection; requested at a place away from the evaluator’s headquarters, the fee for (2) Made payable to the Agricultural such service shall include a per diem Marketing Service, USDA; and charge if the employee(s) performing (3) Mailed to the address provided on the service is paid per diem in accord- the bill for collection. ance with existing travel regulations. (c) The Administrator shall assess in- Per diem charges to applicants and cer- terest, penalties, and administrative tifying agents will cover the same pe- costs on debts not paid by the due date riod of time for which the evaluator(s) shown on a bill for collection and col- receives per diem reimbursement. The lect delinquent debts or refer such per diem rate will be administratively debts to the Department of Justice for determined by the U.S. Department of litigation. Agriculture. Per diem charges shall be- come effective for all applicants for § 205.642 Fees and other charges for initial accreditation and accredited certification. certifying agents on February 20, 2001. Fees charged by a certifying agent The applicant or certifying agent will must be reasonable, and a certifying not be charged a new per diem rate agent shall charge applicants for cer- without notification before the service tification and certified production and is rendered. handling operations only those fees and (d) Other costs. When costs, other charges that it has filed with the Ad- than costs specified in paragraphs (a), ministrator. The certifying agent shall (b), and (c) of this section, are associ- provide each applicant with an esti- ated with providing the services, the mate of the total cost of certification applicant or certifying agent will be and an estimate of the annual cost of charged for these costs. Such costs in- clude but are not limited to equipment updating the certification. The certi- rental, photocopying, delivery, fac- fying agent may require applicants for simile, telephone, or translation certification to pay at the time of ap- charges incurred in association with plication a nonrefundable fee which accreditation services. The amount of shall be applied to the applicant’s fees- the costs charged will be determined for-service account. The certifying administratively by the U.S. Depart- agent may set the nonrefundable por- ment of Agriculture. Such costs shall tion of certification fees; however, the become effective for all applicants for nonrefundable portion of certification initial accreditation and accredited fees must be explained in the fee sched- certifying agents on February 20, 2001. ule submitted to the Administrator. The fee schedule must explain what fee § 205.641 Payment of fees and other amounts are nonrefundable and at charges. what stage during the certification (a) Applicants for initial accredita- process fees become nonrefundable. tion and renewal of accreditation must The certifying agent shall provide all remit the nonrefundable fee, pursuant persons inquiring about the application to § 205.640(a)(3), along with their appli- process with a copy of its fee schedule.
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§§ 205.643–205.649 [Reserved] § 205.662 Noncompliance procedure for certified operations. COMPLIANCE (a) Notification. When an inspection, § 205.660 General. review, or investigation of a certified operation by a certifying agent or a (a) The National Organic Program’s State organic program’s governing Program Manager, on behalf of the State official reveals any noncompli- Secretary, may inspect and review cer- ance with the Act or regulations in tified production and handling oper- this part, a written notification of non- ations and accredited certifying agents compliance shall be sent to the cer- for compliance with the Act or regula- tified operation. Such notification tions in this part. shall provide: (b) The Program Manager may ini- (1) A description of each noncompli- tiate suspension or revocation pro- ance; ceedings against a certified operation: (2) The facts upon which the notifica- (1) When the Program Manager has tion of noncompliance is based; and reason to believe that a certified oper- ation has violated or is not in compli- (3) The date by which the certified ance with the Act or regulations in operation must rebut or correct each this part; or noncompliance and submit supporting (2) When a certifying agent or a State documentation of each such correction organic program’s governing State offi- when correction is possible. cial fails to take appropriate action to (b) Resolution. When a certified oper- enforce the Act or regulations in this ation demonstrates that each non- part. compliance has been resolved, the cer- (c) The Program Manager may ini- tifying agent or the State organic pro- tiate suspension or revocation of a cer- gram’s governing State official, as ap- tifying agent’s accreditation if the cer- plicable, shall send the certified oper- tifying agent fails to meet, conduct, or ation a written notification of non- maintain accreditation requirements compliance resolution. pursuant to the Act or this part. (c) Proposed suspension or revocation. (d) Each notification of noncompli- When rebuttal is unsuccessful or cor- ance, rejection of mediation, non- rection of the noncompliance is not compliance resolution, proposed sus- completed within the prescribed time pension or revocation, and suspension period, the certifying agent or State or revocation issued pursuant to organic program’s governing State offi- § 205.662, § 205.663, and § 205.665 and each cial shall send the certified operation a response to such notification must be written notification of proposed sus- sent to the recipient’s place of business pension or revocation of certification via a delivery service which provides of the entire operation or a portion of dated return receipts. the operation, as applicable to the non- compliance. When correction of a non- § 205.661 Investigation of certified op- compliance is not possible, the notifi- erations. cation of noncompliance and the pro- (a) A certifying agent may inves- posed suspension or revocation of cer- tigate complaints of noncompliance tification may be combined in one no- with the Act or regulations of this part tification. The notification of proposed concerning production and handling suspension or revocation of certifi- operations certified as organic by the cation shall state: certifying agent. A certifying agent (1) The reasons for the proposed sus- must notify the Program Manager of pension or revocation; all compliance proceedings and actions (2) The proposed effective date of taken pursuant to this part. such suspension or revocation; (b) A State organic program’s gov- (3) The impact of a suspension or rev- erning State official may investigate ocation on future eligibility for certifi- complaints of noncompliance with the cation; and Act or regulations in this part con- (4) The right to request mediation cerning organic production or handling pursuant to § 205.663 or to file an appeal operations operating in the State. pursuant to § 205.681.
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(d) Willful violations. Notwithstanding (1) Knowingly sells or labels a prod- paragraph (a) of this section, if a certi- uct as organic, except in accordance fying agent or State organic program’s with the Act, shall be subject to a civil governing State official has reason to penalty of not more than $10,000 per believe that a certified operation has violation. willfully violated the Act or regula- (2) Makes a false statement under the tions in this part, the certifying agent Act to the Secretary, a State organic or State organic program’s governing program’s governing State official, or a State official shall send the certified certifying agent shall be subject to the operation a notification of proposed provisions of section 1001 of title 18, suspension or revocation of certifi- United States Code. cation of the entire operation or a por- tion of the operation, as applicable to § 205.663 Mediation. the noncompliance. Any dispute with respect to denial of (e) Suspension or revocation. (1) If the certification or proposed suspension or certified operation fails to correct the revocation of certification under this noncompliance, to resolve the issue part may be mediated at the request of through rebuttal or mediation, or to file an appeal of the proposed suspen- the applicant for certification or cer- sion or revocation of certification, the tified operation and with acceptance by certifying agent or State organic pro- the certifying agent. Mediation shall gram’s governing State official shall be requested in writing to the applica- send the certified operation a written ble certifying agent. If the certifying notification of suspension or revoca- agent rejects the request for medi- tion. ation, the certifying agent shall pro- (2) A certifying agent or State or- vide written notification to the appli- ganic program’s governing State offi- cant for certification or certified oper- cial must not send a notification of ation. The written notification shall suspension or revocation to a certified advise the applicant for certification or operation that has requested mediation certified operation of the right to re- pursuant to § 205.663 or filed an appeal quest an appeal, pursuant to § 205.681, pursuant to § 205.681, while final resolu- within 30 days of the date of the writ- tion of either is pending. ten notification of rejection of the re- (f) Eligibility. (1) A certified operation quest for mediation. If mediation is ac- whose certification has been suspended cepted by the certifying agent, such under this section may at any time, mediation shall be conducted by a unless otherwise stated in the notifica- qualified mediator mutually agreed tion of suspension, submit a request to upon by the parties to the mediation. If the Secretary for reinstatement of its a State organic program is in effect, certification. The request must be ac- the mediation procedures established companied by evidence demonstrating in the State organic program, as ap- correction of each noncompliance and proved by the Secretary, will be fol- corrective actions taken to comply lowed. The parties to the mediation with and remain in compliance with shall have no more than 30 days to the Act and the regulations in this reach an agreement following a medi- part. ation session. If mediation is unsuc- (2) A certified operation or a person cessful, the applicant for certification responsibly connected with an oper- or certified operation shall have 30 ation whose certification has been re- days from termination of mediation to voked will be ineligible to receive cer- appeal the certifying agent’s decision tification for a period of 5 years fol- pursuant to § 205.681. Any agreement lowing the date of such revocation, Ex- reached during or as a result of the me- cept, That, the Secretary may, when in diation process shall be in compliance the best interest of the certification with the Act and the regulations in program, reduce or eliminate the pe- this part. The Secretary may review riod of ineligibility. any mediated agreement for con- (g) Violations of Act. In addition to formity to the Act and the regulations suspension or revocation, any certified in this part and may reject any agree- operation that: ment or provision not in conformance
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with the Act or the regulations in this (d) Willful violations. Notwithstanding part. paragraph (a) of this section, if the Program Manager has reason to believe § 205.664 [Reserved] that a certifying agent has willfully violated the Act or regulations in this § 205.665 Noncompliance procedure part, the Program Manager shall send for certifying agents. a written notification of proposed sus- (a) Notification. When an inspection, pension or revocation of accreditation review, or investigation of an accred- to the certifying agent. ited certifying agent by the Program (e) Suspension or revocation. When the Manager reveals any noncompliance accredited certifying agent fails to file with the Act or regulations in this an appeal of the proposed suspension or part, a written notification of non- revocation of accreditation, the Pro- compliance shall be sent to the certi- gram Manager shall send a written no- fying agent. Such notification shall tice of suspension or revocation of ac- provide: creditation to the certifying agent. (1) A description of each noncompli- (f) Cessation of certification activities. ance; A certifying agent whose accreditation (2) The facts upon which the notifica- is suspended or revoked must: tion of noncompliance is based; and (1) Cease all certification activities (3) The date by which the certifying in each area of accreditation and in agent must rebut or correct each non- compliance and submit supporting doc- each State for which its accreditation umentation of each correction when is suspended or revoked. correction is possible. (2) Transfer to the Secretary and (b) Resolution. When the certifying make available to any applicable State agent demonstrates that each non- organic program’s governing State offi- compliance has been resolved, the Pro- cial all records concerning its certifi- gram Manager shall send the certifying cation activities that were suspended agent a written notification of non- or revoked. compliance resolution. (g) Eligibility. (1) A certifying agent (c) Proposed suspension or revocation. whose accreditation is suspended by When rebuttal is unsuccessful or cor- the Secretary under this section may rection of the noncompliance is not at any time, unless otherwise stated in completed within the prescribed time the notification of suspension, submit period, the Program Manager shall a request to the Secretary for rein- send a written notification of proposed statement of its accreditation. The re- suspension or revocation of accredita- quest must be accompanied by evi- tion to the certifying agent. The notifi- dence demonstrating correction of each cation of proposed suspension or rev- noncompliance and corrective actions ocation shall state whether the certi- taken to comply with and remain in fying agent’s accreditation or specified compliance with the Act and the regu- areas of accreditation are to be sus- lations in this part. pended or revoked. When correction of (2) A certifying agent whose accredi- a noncompliance is not possible, the tation is revoked by the Secretary notification of noncompliance and the shall be ineligible to be accredited as a proposed suspension or revocation may certifying agent under the Act and the be combined in one notification. The regulations in this part for a period of notification of proposed suspension or not less than 3 years following the date revocation of accreditation shall state: of such revocation. (1) The reasons for the proposed sus- pension or revocation; §§ 205.666–205.667 [Reserved] (2) The proposed effective date of the suspension or revocation; § 205.668 Noncompliance procedures (3) The impact of a suspension or rev- under State organic programs. ocation on future eligibility for accred- (a) A State organic program’s gov- itation; and erning State official must promptly (4) The right to file an appeal pursu- notify the Secretary of commencement ant to § 205.681. of any noncompliance proceeding
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against a certified operation and for- lieve that the agricultural input or ward to the Secretary a copy of each product has come into contact with a notice issued. prohibited substance or has been pro- (b) A noncompliance proceeding, duced using excluded methods. Such brought by a State organic program’s tests must be conducted by the applica- governing State official against a cer- ble State organic program’s governing tified operation, shall be appealable State official or the certifying agent at pursuant to the appeal procedures of the official’s or certifying agent’s own the State organic program. There shall expense. be no subsequent rights of appeal to (c) The preharvest or postharvest tis- the Secretary. Final decisions of a sue test sample collection pursuant to State may be appealed to the United States District Court for the district in paragraph (b) of this section must be which such certified operation is lo- performed by an inspector representing cated. the Administrator, applicable State or- (c) A State organic program’s gov- ganic program’s governing State offi- erning State official may review and cial, or certifying agent. Sample integ- investigate complaints of noncompli- rity must be maintained throughout ance with the Act or regulations con- the chain of custody, and residue test- cerning accreditation of certifying ing must be performed in an accredited agents operating in the State. When laboratory. Chemical analysis must be such review or investigation reveals made in accordance with the methods any noncompliance, the State organic described in the most current edition program’s governing State official of the Official Methods of Analysis of the shall send a written report of non- AOAC International or other current ap- compliance to the Program Manager. plicable validated methodology deter- The report shall provide a description mining the presence of contaminants of each noncompliance and the facts in agricultural products. upon which the noncompliance is (d) Results of all analyses and tests based. performed under this section: § 205.669 [Reserved] (1) Must be promptly provided to the Administrator; Except, That, where a INSPECTION AND TESTING, REPORTING, State organic program exists, all test AND EXCLUSION FROM SALE results and analyses shall be provided to the State organic program’s gov- § 205.670 Inspection and testing of ag- erning State official by the applicable ricultural product to be sold or la- certifying party that requested testing; beled ‘‘organic.’’ and (a) All agricultural products that are (2) Will be available for public access, to be sold, labeled, or represented as unless the testing is part of an ongoing ‘‘100 percent organic,’’ ‘‘organic,’’ or compliance investigation. ‘‘made with organic (specified ingredi- (e) If test results indicate a specific ents or food group(s))’’ must be made agricultural product contains pesticide accessible by certified organic produc- residues or environmental contami- tion or handling operations for exam- nants that exceed the Food and Drug ination by the Administrator, the ap- Administration’s or the Environmental plicable State organic program’s gov- Protection Agency’s regulatory erning State official, or the certifying tolerences, the certifying agent must agent. (b) The Administrator, applicable promptly report such data to the Fed- State organic program’s governing eral health agency whose regulatory State official, or the certifying agent tolerance or action level has been ex- may require preharvest or postharvest ceeded. testing of any agricultural input used or agricultural product to be sold, la- § 205.671 Exclusion from organic sale. beled, or represented as ‘‘100 percent When residue testing detects prohib- organic,’’ ‘‘organic,’’ or ‘‘made with or- ited substances at levels that are ganic (specified ingredients or food greater than 5 percent of the Environ- group(s))’’ when there is reason to be- mental Protection Agency’s tolerance
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for the specific residue detected or un- §§ 205.673–205.679 [Reserved] avoidable residual environmental con- tamination, the agricultural product ADVERSE ACTION APPEAL PROCESS must not be sold, labeled, or rep- resented as organically produced. The § 205.680 General. Administrator, the applicable State or- (a) Persons subject to the Act who ganic program’s governing State offi- believe they are adversely affected by a cial, or the certifying agent may con- noncompliance decision of the National duct an investigation of the certified Organic Program’s Program Manager operation to determine the cause of the may appeal such decision to the Ad- prohibited substance. ministrator. (b) Persons subject to the Act who § 205.672 Emergency pest or disease believe that they are adversely affected treatment. by a noncompliance decision of a State organic program may appeal such deci- When a prohibited substance is ap- sion to the State organic program’s plied to a certified operation due to a governing State official who will ini- Federal or State emergency pest or dis- tiate handling of the appeal pursuant ease treatment program and the cer- to appeal procedures approved by the tified operation otherwise meets the Secretary. requirements of this part, the certifi- (c) Persons subject to the Act who cation status of the operation shall not believe that they are adversely affected be affected as a result of the applica- by a noncompliance decision of a certi- tion of the prohibited substance: Pro- fying agent may appeal such decision vided, That: to the Administrator, Except, That, (a) Any harvested crop or plant part when the person is subject to an ap- to be harvested that has contact with a proved State organic program, the ap- prohibited substance applied as the re- peal must be made to the State organic sult of a Federal or State emergency program. pest or disease treatment program can- (d) All written communications be- not be sold, labeled, or represented as tween parties involved in appeal pro- organically produced; and ceedings must be sent to the recipient’s (b) Any livestock that are treated place of business by a delivery service with a prohibited substance applied as which provides dated return receipts. the result of a Federal or State emer- (e) All appeals shall be reviewed, gency pest or disease treatment pro- heard, and decided by persons not in- gram or product derived from such volved with the decision being ap- treated livestock cannot be sold, la- pealed. beled, or represented as organically § 205.681 Appeals. produced: Except, That: (1) Milk or milk products may be (a) Certification appeals. An applicant sold, labeled, or represented as organi- for certification may appeal a certi- fying agent’s notice of denial of certifi- cally produced beginning 12 months fol- cation, and a certified operation may lowing the last date that the dairy ani- appeal a certifying agent’s notification mal was treated with the prohibited of proposed suspension or revocation of substance; and certification to the Administrator, Ex- (2) The offspring of gestating mam- cept, That, when the applicant or cer- malian breeder stock treated with a tified operation is subject to an ap- prohibited substance may be consid- proved State organic program the ap- ered organic: Provided, That, the breed- peal must be made to the State organic er stock was not in the last third of program which will carry out the ap- gestation on the date that the breeder peal pursuant to the State organic pro- stock was treated with the prohibited gram’s appeal procedures approved by substance. the Secretary.
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(1) If the Administrator or State or- ter of notification or within 30 days ganic program sustains a certification from receipt of the notification, which- applicant’s or certified operation’s ap- ever occurs later. The appeal will be peal of a certifying agent’s decision, considered ‘‘filed’’ on the date received the applicant will be issued organic by the Administrator or by the State certification, or a certified operation organic program. A decision to deny, will continue its certification, as appli- suspend, or revoke certification or ac- cable to the operation. The act of sus- creditation will become final and non- taining the appeal shall not be an ad- appealable unless the decision is ap- verse action subject to appeal by the pealed in a timely manner. affected certifying agent. (d) Where and what to file. (1) Appeals (2) If the Administrator or State or- to the Administrator must be filed in ganic program denies an appeal, a for- writing and addressed to Adminis- mal administrative proceeding will be trator, USDA–AMS, Room 3071–S, P.O. initiated to deny, suspend, or revoke Box 96456, Washington, DC 20090–6456. the certification. Such proceeding shall (2) Appeals to the State organic pro- be conducted pursuant to the U.S. De- gram must be filed in writing to the partment of Agriculture’s Uniform address and person identified in the let- Rules of Practice or the State organic ter of notification. program’s rules of procedure. (3) All appeals must include a copy of (b) Accreditation appeals. An applicant the adverse decision and a statement of for accreditation and an accredited cer- the appellant’s reasons for believing tifying agent may appeal the Program that the decision was not proper or Manager’s denial of accreditation or made in accordance with applicable proposed suspension or revocation of program regulations, policies, or proce- accreditation to the Administrator. dures. (1) If the Administrator sustains an appeal, an applicant will be issued ac- §§ 205.682–205.689 [Reserved] creditation, or a certifying agent will continue its accreditation, as applica- MISCELLANEOUS ble to the operation. (2) If the Administrator denies an ap- § 205.690 OMB control number. peal, a formal administrative pro- The control number assigned to the ceeding to deny, suspend, or revoke the information collection requirements in accreditation will be initiated. Such this part by the Office of Management proceeding shall be conducted pursuant and Budget pursuant to the Paperwork to the U.S. Department of Agri- Reduction Act of 1995, 44 U.S C. Chap- culture’s Uniform Rules of Practice, 7 ter 35, is OMB number 0581–0181. CFR part 1, Subpart H. (c) Filing period. An appeal of a non- §§ 205.691–205.699 [Reserved] compliance decision must be filed with- in the time period provided in the let- PARTS 206–209 [Reserved]
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