9 CFR Ch. II (1–1–12 Edition)

§ 206.3 9 CFR Ch. II (1–1–12 Edition)

GIPSA, Suite 317, 210 Walnut Street, numbers of swine to be delivered under Des Moines, Iowa 50309. the terms of expansion clauses in the (2) Regions. Information in the report contracts at any time during the fol- will be aggregated and reported by geo- lowing 12 calendar months. graphic regions. Geographic regions (v) The sum of packers’ reported esti- will be defined in such a manner to pro- mates of the maximum total number of vide as much information as possible swine that potentially could be deliv- while maintaining confidentiality in ered during each of the next 6 and 12 accordance with section 251 of the Ag- months if all expansion clauses in cur- ricultural Marketing Act (7 U.S.C. 1636) rent contracts are executed. The report and may be modified from time to will indicate the sum of estimated time. maximum potential deliveries by geo- (3) Reported information. The monthly graphic reporting region and by con- report will provide the following infor- tract type. mation: (h) Where and how do I file a waiver re- (i) The existing contract types for quest? The waiver request must be sub- each geographic region. mitted in writing and include a state- (ii) The contract types currently ment that the packer does not procure being made available to additional pro- swine using marketing agreements. ducers or available for renewal to cur- The packer must send the waiver re- rently contracted producers in each ge- quest to the GIPSA Regional Office in ographic region. Des Moines, Iowa. If the waiver request (iii) The sum of packers’ reported es- is approved, GIPSA will inform the timates of the total number of swine packer in writing that it has been committed by contract for delivery granted a waiver for 12 months fol- during the next 6 and 12 months begin- lowing the date of receipt of the waiver ning with the month the report is pub- request unless the status of the packer lished. The report will indicate the changes during that year. The packer number of swine committed by geo- will be notified to submit the informa- graphic reporting region and by con- tion required in this part if it begins tract type. using marketing agreements during (iv) The types of conditions or cir- the waiver period or if GIPSA deter- cumstances as reported by packers mines that the packer utilizes mar- that could result in expansion in the keting agreements.

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EDITORIAL NOTE: Nomenclature changes to chapter III appear at 69 FR 18803, Apr. 9 2004.

SUBCHAPTER A—AGENCY ORGANIZATION AND TERMINOLOGY; MANDA- TORY MEAT AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION

Part Page 300 Agency mission and organization ...... 87 301 Terminology; adulteration and misbranding standards ...... 90 302 Application of inspection and other requirements .. 95 303 Exemptions ...... 96 304 Application for inspection; grant of inspection ...... 104 305 Official numbers; inauguration of inspection; withdrawal of inspection; reports of violation ...... 105 306 Assignment and authorities of program employees 106 307 Facilities for inspection ...... 107 308 [Reserved] 309 Ante-mortem inspection...... 112 310 Post-mortem inspection...... 120 311 Disposal of diseased or otherwise adulterated carcasses and parts ...... 137 312 Official marks, devices and certificates ...... 147 313 Humane slaughter of livestock ...... 151 314 Handling and disposal of condemned or other inedible products at official establishments ...... 157 315 Rendering or other disposal of carcasses and parts passed for cooking ...... 160 316 Marking products and their containers ...... 161 317 Labeling, marking devices, and containers ...... 166 318 Entry into official establishments; reinspection and preparation of products ...... 243 319 Definitions and standards of identity or composition ...... 295 320 Records, registration, and reports ...... 315 321 Cooperation with States and territories ...... 317 322 Exports ...... 319 83

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Part Page 325 Transportation ...... 320 327 Imported products...... 331 329 Detention; seizure and condemnation; criminal offenses ...... 350 331 Special provisions for designated States and Terri- tories; and for designation of establishments which endanger public health and for such designated establishments ...... 352 332 Selected establishments; cooperative program for interstate shipment of carcasses, parts of carcasses, meat, and meat food products ...... 357 335 Rules of practice governing proceedings under the Federal Meat Inspection Act ...... 362 350 Special services relating to meat and other products ...... 363 351 Certification of technical animal fats for export .... 365 352 Exotic animals and horses; voluntary inspection ... 372 354 Voluntary inspection of rabbits and edible products thereof ...... 380 355 Certified products for dogs, cats, and other carnivora; inspection, certification, and identification as to class, quality, quantity, and condition ...... 404 362 Voluntary poultry inspection regulations ...... 416 381 Poultry products inspection regulations ...... 420

SUBCHAPTERS B–C [RESERVED]

SUBCHAPTER D—FOOD SAFETY AND INSPECTION SERVICE ADMINISTRATIVE PROVISIONS 390 Freedom of information and public information .... 614 391 Fees and charges for inspection services and laboratory accreditation ...... 616 392 Petitions for rulemaking ...... 618

SUBCHAPTER E—REGULATORY REQUIREMENTS UNDER THE FEDERAL MEAT INSPECTION ACT AND THE POULTRY PRODUCTS INSPECTION ACT 416 Sanitation ...... 621 417 Hazard Analysis and Critical Control Point (HACCP) Systems ...... 625 424 Preparation and processing operations ...... 629 430 Requirements for specific classes of product ...... 655 439 Accreditation of non-Federal chemistry laboratories ...... 658 441 Consumer protection standards: raw products ...... 667 442 Quantity of contents labeling and procedures and requirements for accurate weights ...... 669

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Part Page 500 Rules of practice ...... 671

SUBCHAPTER I—EGG PRODUCTS INSPECTION 590 Inspection of eggs and egg products (Egg Products Inspection Act) ...... 674 592 Voluntary inspection of egg products ...... 721

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PART 300—AGENCY MISSION AND (2) The Poultry Products Inspection ORGANIZATION Act, as amended (PPIA) (21 U.S.C. 451 et seq.); Sec. (3) The Egg Products Inspection Act, 300.1 Purpose. as amended (EPIA) (21 U.S.C. 1031 et 300.2 FSIS responsibilities. seq.), except for the shell egg surveil- 300.3 FSIS organization. lance program, voluntary laboratory 300.4 Organizational terminology; per- analyses of egg products, and the vol- sonnel. untary grading program; 300.6 Access to establishments and other (4) The Humane Slaughter Act (7 places of business. U.S.C. 1901–1906); AUTHORITY: 21 U.S.C. 451–470, 601–695, 1031– (5) The Talmadge-Aiken Act (7 U.S.C. 1056; 7 U.S.C. 138–138i, 450, 1621–1627, 1901–1906; 450), with respect to cooperation with 7 CFR 2.7, 2.18, 2.53. States in the administration of the SOURCE: 63 FR 72354, Dec. 31, 1998, unless Federal Meat Inspection Act and the otherwise noted. Poultry Products Inspection Act; § 300.1 Purpose. (6) The Agricultural Marketing Act of 1946, as amended (7 U.S.C. 1621–1627), This part describes the duties and or- relating to voluntary inspection of ganization of the Food Safety and In- poultry and edible products thereof; spection Service (FSIS), an agency of voluntary inspection and certification the United States Department of Agri- of technical animal fat; certified prod- culture (USDA). It also includes rules ucts for dogs, cats, and other on the access of government employees carnivora; voluntary inspection of rab- to regulated places of business. bits and edible products thereof; and [63 FR 72354, Dec. 31, 1998, as amended at 69 voluntary inspection and certification FR 253, Jan. 5, 2004] of edible meat and other products; and (7) The National Laboratory Accredi- § 300.2 FSIS responsibilities. tation Program (7 U.S.C. 138–138i) with (a) Delegations of authority. The Sec- respect to laboratories accredited only retary of Agriculture and Under Sec- for pesticide residue analysis in meat retary for Food Safety have delegated and poultry products. to the Administrator of the Food Safe- ty and Inspection Service the responsi- [63 FR 72354, Dec. 31, 1998, as amended at 69 bility for exercising the functions of FR 253, Jan. 5, 2004] the Secretary of Agriculture under var- § 300.3 FSIS organization. ious statutes (see 7 CFR 2.7, 2.18, and 2.53). (a) General. The organization of FSIS (b) Implementing regulations. This reflects the agency’s primary regu- chapter of title 9 of the Code of Federal latory responsibilities: implementation Regulations (9 CFR chapter III) in- of the FMIA, the PPIA, and the EPIA. cludes, in addition to administrative FSIS implements the inspection provi- rules, rules and regulations that imple- sions of the FMIA, the PPIA, and the ment provisions of the following stat- EPIA through its field structure. utes: (b) Headquarters. FSIS has eight prin- (1) The Federal Meat Inspection Act, cipal components or offices, each of as amended (FMIA) (21 U.S.C. 601 et which is under the direction of a Dep- seq.), except provisions pertaining to uty Administrator. The Deputy Admin- the inspection and certification of the istrators, along with their staffs, and condition of animals for export, and re- the Administrator, along with the Of- lated legislation; fice of the Administrator and three

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staff offices that report to the Admin- ensure that Agency programs are func- istrator, are located at U.S. Depart- tioning in an efficient and effective ment of Agriculture headquarters in manner; the Office of Public Affairs, Washington, DC. Education, and Outreach, which is re- (1) Program Offices. FSIS’s head- sponsible for facilitating communica- quarters offices are the Office of Public tions between FSIS and Congress, the Health and Science, which provides sci- Agency’s constituents, and the media; entific analysis, advice, data, and rec- and the Office of International Affairs, ommendations on matters involving which is responsible for recommending public health and science; the Office of and developing international policy ac- Management, which provides central- tivities. ized administrative and support serv- (2) [Reserved] ices; the Office of Policy and Program (c) FSIS’s field structure con- Development, which develops and ar- Field. ticulates the Agency’s policies regard- sists of eighteen district offices and a ing food safety and other consumer technical center. protections; the Office of Field Oper- (1) District offices. Each district office, ations, which manages regulatory over- under the direction of a District Man- sight and inspection (see paragraph (c) ager, manages a farm-to-table food of this section); the Office of Food Se- safety program of regulatory oversight curity and Emergency Preparedness, and inspection in a district consisting which works to prevent or, if nec- of a State or several States and terri- essary, coordinate a response to an in- tories. tentional attack on the food supply; The locations of the district offices the Office of Program Evaluation, En- and the districts’ geographic bound- forcement, and Review, which acts to aries are as follows:

Alameda, CA ...... California. Boulder, CO ...... Arizona, Colorado, Nevada, New Mexico, Utah, Alaska, Amer- Salem, OR (satellite office) ican Samoa, Guam, Hawaii, Idaho, Northern Mariana Is- lands, Oregon, and Washington. Minneapolis, MN ...... Minnesota, Montana, North Dakota, South Dakota, and Wyo- ming. Des Moines, IA ...... Iowa and Nebraska. Lawrence, KS ...... Kansas and Missouri. Springdale, AR ...... Arkansas, Louisiana, and Oklahoma. Dallas, TX ...... Texas. Madison, WI ...... Michigan and Wisconsin. Chicago, IL ...... Illinois, Ohio, and Indiana. Pickering, OH, (satellite office) Philadelphia, PA ...... Pennsylvania and New Jersey. Albany, NY ...... Connecticut, Maine, Massachusetts, New Hampshire, New York, Rhode Island, and Vermont. Beltsville, MD ...... Delaware, District of Columbia, Maryland, Virginia, and West Virginia. Raleigh, NC ...... North Carolina, South Carolina, and Kentucky. Atlanta, GA ...... Florida, Georgia, Puerto Rico, and the Virgin Islands. Jackson, MS ...... Alabama, Mississippi, and Tennessee.

(2) Technical Service Center. The Tech- § 300.4 Organizational terminology; nical Service Center, which is located personnel. in Omaha, Nebraska, provides tech- (a) Unless otherwise specifically pro- nical guidance, review, and training on vided or required in the context of a the interpretation and application of particular part of the regulations: regulatory requirements. [63 FR 72354, Dec. 31, 1998, as amended at 69 FR 253, Jan. 5, 2004]

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Administrator means the Adminis- ity previously delegated to area super- trator of the Food Safety and Inspec- visors and import supervisors now is tion Service or any other officer or em- delegated to inspection program super- ployee of the Department to whom au- visors in the successor district offices. thority has been or may in the future be delegated to act in his or her stead. [69 FR 253, Jan. 5, 2004] Circuit Supervisor means the official of the Inspection Service who is as- § 300.6 Access to establishments and other places of business. signed responsibility for supervising the conduct of inspection at a specific (a) General. Upon presentation of cre- group of official establishments. dentials— Inspection program, inspection service, (1) Persons subject to provisions of or program means the organizational the FMIA or the PPIA must afford rep- unit within the Department with re- resentatives of the Secretary access to sponsibility for carrying out the FMIA, establishments that slaughter or other- the PPIA, and the EPIA. wise prepare livestock products or Inspection program employee, inspec- process poultry products and to other tion service employee, or program em- places of business subject to regulation ployee means an inspector or other gov- thereunder; and ernment employee who is authorized to (2) Persons subject to provisions of conduct any inspection or perform any the EPIA must afford representatives other duty in connection with the in- of the Secretary access as specified in spection program, inspection service, part 590 of this chapter. or program. Inspection service supervisor or Inspec- (b) Meat and poultry establishments tion program supervisor means an in- and related industries. (1) At all times, spection program or service employee by day or night, whether the establish- or program employee who is delegated ment is being operated or not, inspec- authority to exercise supervision over tion program employees must have ac- one or more phases of the inspection cess to the premises and to every part program. of an establishment that slaughters Inspector means an inspector of the livestock or otherwise prepares meat inspection program, inspection service, products or slaughters poultry or oth- and program. (‘‘Inspector’’ includes an erwise processes poultry products that employee or official of the Federal gov- are subject to inspection for the pur- ernment or the government of a State pose of conducting an inspection or or territory or the District of Columbia performing any other inspection pro- who is authorized by the Administrator gram duty. The numbered official to inspect meat and meat products or badge of an inspection program em- poultry and poultry products under the ployee is sufficient identification to authority of the FMIA or the PPIA, re- entitle him or her to admittance to all spectively, under an agreement entered parts of such an establishment and its into between the Administrator and premises. the appropriate State or other agency.) (2) At all ordinary business hours, Inspector in charge or IIC means an inspection program employee, inspec- upon presentation of credentials by a tion service employee, or program em- representative of the Secretary, any ployee who has primary responsibility person (including any firm or corpora- for inspection program functions at a tion or other business unit) subject to particular official establishment. recordkeeping requirements under sec- Secretary means the Secretary of Ag- tion 202 of the FMIA or section 11(b) of riculture of the United States or his or the PPIA must permit such representa- her delegate. tive to enter his or her place of busi- (b) FSIS has replaced the regional of- ness to examine the facilities and in- fice and import field office structure ventory and to examine and copy the referenced in some parts of subchapter records specified in § 320.1 and § 381.175, A of this chapter. Authority previously respectively, of this chapter and, upon delegated to Regional Directors now is payment of the fair market value delegated to district managers; author-

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therefor, take reasonable samples of (C) A color additive which may, in the inventory. the judgment of the Administrator, make such article unfit for human [63 FR 72354, Dec. 31, 1998, as amended at 69 FR 254, Jan. 5, 2004] food; (ii) If it is, in whole or in part, a raw agricultural commodity and such com- PART 301—TERMINOLOGY; ADUL- modity bears or contains a pesticide TERATION AND MISBRANDING chemical which is unsafe within the STANDARDS meaning of section 408 of the Federal Food, Drug, and Cosmetic Act; Sec. (iii) If it bears or contains any food 301.1 General. additive which is unsafe within the 301.2 Definitions. meaning of section 409 of the Federal AUTHORITY: 21 U.S.C. 601–695; 7 U.S.C. 138– Food, Drug, and Cosmetic Act; 138i, 450, 1901–1906; 7 CFR 2.7, 2.18, 2.53. (iv) If it bears or contains any color additive which is unsafe within the § 301.1 General. meaning of section 706 of the Federal For purposes of this chapter and un- Food, Drug, and Cosmetic Act: Pro- less otherwise specifically provided by vided, That an article which is not regulation or required in the context of deemed adulterated under paragraphs particular regulations: (aa)(2) (ii), (iii), or (iv) of this section (a) Terms have the meanings set shall nevertheless be deemed adulter- forth in this part; ated if use of the pesticide chemical (b) The singular form also imports food additive, or color additive in or on the plural, and the masculine form also such article is prohibited by the regu- imports the feminine and vice versa. lations in this subchapter in official establishments; [69 FR 254, Jan. 5, 2004] (3) If it consists in whole or in part of any filthy, putrid, or decomposed sub- § 301.2 Definitions. stance or is for any other reason un- As used in this subchapter, unless sound, unhealthful, unwholesome, or otherwise required by the context, the otherwise unfit for human food; following terms shall be construed, re- (4) If it has been prepared, packed, or spectively, to mean: held under unsanitary conditions The Act. The Federal Meat Inspection whereby it may have become contami- Act, as amended, (34 Stat. 1260, as nated with filth, or whereby it may amended, 81 Stat. 584, 84 Stat. 438, 92 have been rendered injurious to health; Stat. 1069, 21 U.S.C., sec. 601 et seq.). (5) If it is, in whole or in part, the Adulterated. This term applies to any product of an animal which has died carcass, part thereof, meat or meat otherwise than by slaughter; food product under one or more of the (6) If its container is composed, in following circumstances: whole or in part, of any poisonous or (1) If it bears or contains any such deleterious substance which may poisonous or deleterious substance render the contents injurious to which may render it injurious to health; health; but in case the substance is not (7) If it has been intentionally sub- an added substance, such article shall jected to radiation, unless the use of not be considered adulterated under the radiation was in conformity with a this clause if the quantity of such sub- regulation or exemption in effect pur- stance in or on such article does not suant to section 409 of the Federal ordinarily render it injurious to health; Food, Drug, and Cosmetic Act; (2)(i) If it bears or contains (by rea- (8) If any valuable constituent has son of administration of any substance been in whole or in part omitted or ab- to the live animal or otherwise) any stracted therefrom; or if any substance added poisonous or added deleterious has been substituted, wholly or in part substance (other than one which is: therefor; or if damage or inferiority (A) A pesticide chemical in or on a has been concealed in any manner; or if raw agricultural commodity; any substance has been added thereto (B) A food additive; or or mixed or packed therewith so as to

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increase its bulk or weight, or reduce 325.13 of this subchapter to deter its use its quality or strength, or make it ap- as a human food, or it is naturally in- pear better or of greater value than it edible by humans; e.g., hoofs or horns is; or, in their natural state. (9) If it is margarine containing ani- Captive bolt. A stunning instrument mal fat and any of the raw material which when activated drives a bolt out used therein consisted in whole or in of a barrel for a limited distance. part of any filthy, putrid, or decom- Carbon dioxide. A gaseous form of the posed substance, or is otherwise adul- chemical formula CO2. terated. Carbon dioxide concentration. Ratio of Anesthesia. Loss of sensation or feel- carbon dioxide gas and atmospheric ing. air. Animal food. Any article intended for Carcass. All parts, including viscera, use as food for dogs, cats, or other ani- of any slaughtered livestock. mals derived wholly, or in part, from Chemical preservative. Any chemical the carcass or parts or products of the carcass of any livestock, except that that, when added to a meat or meat the term animal food as used herein food product, tends to prevent or re- does not include: tard deterioration thereof, but does not (1) Processed dry animal food or include common salt, sugars, vinegars, (2) Livestock or poultry feeds manu- spices, or oils extracted from spices or factured from processed livestock by- substances added to meat and meat products (such as meatmeal tankage, food products by exposure to wood meat and bonemeal, bloodmeal, and smoke. feed grade animal fat). Other definitions, if any, that are ap- Animal food manufacturer. Any person plicable only for purposes of a specific engaged in the business of manufac- part of the regulations in this sub- turing or processing animal food. chapter, are set forth in such part. Artificial coloring. A coloring con- Commerce. Commerce between any taining any dye or pigment, which dye State, any Territory, or the District of or pigment was manufactured by a Columbia, and any place outside there- process of synthesis or other similar of; or within any Territory not orga- artifice, or a coloring which was manu- nized with a legislative body, or the factured by extracting a natural dye or District of Columbia. natural pigment from a plant or other Consciousness. Responsiveness of the material in which such dye or pigment brain to the impressions made by the was naturally produced. senses. Artificial flavoring. A flavoring con- Cutting up. Any division of any car- taining any sapid or aromatic con- cass or part thereof, except that the stituent, which constituent was manu- trimming of carcasses or parts thereof factured by a process of synthesis or to remove surface contaminants is not other similar artifice. considered as cutting up. Biological residue. Any substance, in- Dead livestock. The body (cadaver) of cluding metabolites, remaining in live- livestock which has died otherwise stock at time of slaughter or in any of than by slaughter. its tissues after slaughter as the result Dying, diseased, or disabled livestock. of treatment or exposure of the live- Livestock which has or displays symp- stock to a pesticide, organic or inor- toms of having any of the following: ganic compound, hormone, hormone- (1) Central nervous system disorder; like substance, growth promoter, anti- (2) Abnormal temperature (high or biotic, anthelmintic, tranquilizer, or other therapeutic or prophylactic low); agent. (3) Difficult breathing; Capable of use as human food. This (4) Abnormal swellings; term applies to any carcass, or part or (5) Lack of muscular coordination; product of a carcass, of any livestock, (6) Inability to walk normally or unless it is denatured or otherwise stand; identified as required by the applicable (7) Any of the conditions for which provisions of §§ 314.3, 314.10, 325.11, and livestock is required to be condemned

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on ante-mortem inspection in accord- Labeling. All labels and other writ- ance with the regulations in part 309 of ten, printed, or graphic matter: this subchapter. (1) Upon any article or any of its con- Edible. Intended for use as human tainers or wrappers, or food. (2) Accompanying such article. Experimental animal. Any animal used Livestock. Cattle, sheep, swine, goat, in any research investigation involving horse, mule, or other equine. the feeding or other administration of, Meat. (1) The part of the muscle of or subjection to, an experimental bio- any cattle, sheep, swine, or goats logical product, drug, or chemical or which is skeletal or which is found in any nonexperimental biological prod- the tongue, diaphragm, heart, or esoph- uct, drug, or chemical used in a man- agus, with or without the accom- ner for which it was not intended. panying and overlying fat, and the por- Exposure time. The period of time an tions of bone (in bone-in product such animal is exposed to an anesthesia-pro- as T-bone or porterhouse steak), skin, ducing carbon dioxide concentration. sinew, nerve, and blood vessels which Federal Food, Drug, and Cosmetic Act. normally accompany the muscle tissue The Act so entitled, approved June 25, and that are not separated from it in 1938 (52 Stat. 1040), and Acts amend- the process of dressing. As applied to atory thereof or supplementary there- products of equines, this term has a to. comparable meaning. Firm. Any partnership, association, or other unincorporated business orga- (i) Meat does not include the muscle nization. found in the lips, snout, or ears. Further processing. Smoking, cooking, (ii) Meat may not include significant canning, curing, refining, or rendering portions of bone, including hard bone in an official establishment of product and related components, such as bone previously prepared in official estab- marrow, or any amount of brain, lishments. trigeminal ganglia, spinal cord, or dor- Immediate container. The receptacle or sal root ganglia (DRG). other covering in which any product is (2) [Reserved] directly contained or wholly or par- Meat broker. Any person engaged in tially enclosed. the business of buying or selling car- Inedible. Adulterated, uninspected, or casses, parts of carcasses, meat or not intended for use as human food. meat food products of livestock on Inhumane slaughter or handling in con- commission, or otherwise negotiating nection with slaughter. Slaughter or purchases or sales of such articles handling in connection with slaughter other than for his/her own account or not in accordance with the Act of Au- as an employee of another person. gust 27, 1958 (72 Stat. 862; 7 U.S.C. 1901 Meat byproduct. Any part capable of through 1906, as amended by the Hu- use as human food, other than meat, mane Methods of Slaughter Act of 1978, which has been derived from one or 92 Stat. 1069) and part 313 of this sub- more cattle, sheep, swine, or goats. chapter. This term, as applied to products of ‘‘Inspected and passed’’ or ‘‘U.S. In- equines, shall have a meaning com- spected and Passed’’ or ‘‘U.S. Inspected parable to that provided in this para- and Passed by Department of Agri- graph with respect to cattle, sheep, culture’’ (or any authorized abbreviation swine, and goats. thereof). This term means that the Meat food product. Any article capa- product so identified has been in- ble of use as human food which is made spected and passed under the regula- wholly or in part from any meat or tions in this subchapter, and at the other portion of the carcass of any cat- time it was inspected, passed, and iden- tle, sheep, swine, or goats, except those tified, it was found to be not adulter- exempted from definition as a meat ated. food product by the Administrator in Label. A display of written, printed, specific cases or by the regulations in or graphic matter upon the immediate part 317 of this subchapter, upon a de- container (not including package lin- termination that they contain meat or ers) of any article. other portions of such carcasses only in

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a relatively small proportion or his- ulations in part 319 of this subchapter torically have not been considered by unless: consumers as products of the meat food (i) It conforms to such definition and industry, and provided that they com- standard, and ply with any requirements that are im- (ii) Its label bears the name of the posed in such cases or regulations as food specified in the definition and conditions of such exemptions to as- standard and, insofar as may be re- sure that the meat or other portions of quired by such regulations, the com- such carcasses contained in such arti- mon names of optional ingredients cles are not adulterated and that such (other than spices, flavoring, and color- articles are not represented as meat ing) present in such food; food products. This term, as applied to (8) If it purports to be or is rep- food products of equines, shall have a resented as a food for which a standard meaning comparable to that provided or standards of fill of container have in this paragraph with respect to cat- been prescribed by the regulations in tle, sheep, swine, and goats. part 319 of this subchapter, and it falls Misbranded. This term applies to any below the standard of fill of container carcass, part thereof, meat or meat applicable thereto, unless its label food product under one or more of the bears, in such manner and form as such following circumstances: regulations specify, a statement that it (1) If its labeling is false or mis- falls below such standard; leading in any particular; (9) If it is not subject to the provi- (2) If it is offered for sale under the sions of paragraph (vv)(7)(ii) of this name of another food; section unless its label bears: (i) The common or usual name of the (3) If it is an imitation of another food, if any there be, and food, unless its label bears, in type of (ii) In case it is fabricated from two uniform size and prominence, the word or more ingredients, the common or ‘‘imitation’’ and immediately there- usual name of each such ingredient, ex- after, the name of the food imitated; cept as otherwise provided in part 317 (4) If its container is so made, of this subchapter; formed, or filled as to be misleading; (10) If it purports to be or is rep- (5) If in a package or other container resented for special dietary uses, unless unless it bears a label showing: its label bears such information con- (i) The name and place of business of cerning its vitamin, mineral, and other the manufacturer, packer, or dis- dietary properties as is required by the tributor; and regulations in part 317 of this sub- (ii) An accurate statement of the chapter. quantity of the contents in terms of (11) If it bears or contains any artifi- weight, measure, or numerical count; cial flavoring, artificial coloring, or except as otherwise provided in part 317 chemical preservative, unless it bears a of this subchapter with respect to the label stating that fact; except as other- quantity of contents; wise provided by the regulations in (6) If any word, statement, or other part 317 of this subchapter; or information required by or under au- (12) If it fails to bear, directly there- thority of the Act to appear on the on or on its containers, when required label or other labeling is not promi- by the regulations in part 316 or 317 of nently placed thereon with such con- this subchapter, the inspection legend spicuousness (as compared with other and, unrestricted by any of the fore- words, statements, designs, or devices, going, such other information as the in the labeling) and in such terms as to Administrator may require in such reg- render it likely to be read and under- ulations to assure that it will not have stood by the ordinary individual under false or misleading labeling and that customary conditions of purchase and the public will be informed of the man- use; ner of handling required to maintain (7) If it purports to be or is rep- the article in a wholesome condition. resented as a food for which a defini- Nonfood compound. Any substance tion and standard of identity or com- proposed for use in official establish- position has been prescribed by the reg- ments, the intended use of which will

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not result, directly or indirectly, in the evant regulations. This definition does substance becoming a component or not apply to subpart G of part 318. otherwise affecting the characteristics Process schedule. A written descrip- of meat food and meat products, ex- tion of processing procedures, con- cluding labeling and packaging mate- sisting of any number of specific, se- rials as covered in part 317 of the sub- quential operations directly under the chapter. control of the establishment employed Official certificate. Any certificate in the manufacture of a specific prod- prescribed by the regulations in this uct, including the control, monitoring, subchapter for issuance by an inspector verification, validation, and corrective or other person performing official action activities associated with pro- functions under the Act. duction. This definition does not apply Official device. Any device prescribed to subpart G of part 318. by the regulations in part 312 of this Product. Any carcass, meat, meat by- subchapter for use in applying any offi- product, or meat food product, capable cial mark. of use as human food. Official establishment. Any slaugh- Renderer. Any person engaged in the tering, cutting, boning, meat canning, business of rendering carcasses or parts curing, smoking, salting, packing, ren- or products of the carcasses of any live- dering, or similar establishment at stock except rendering conducted which inspection is maintained under under inspection or exemption under the regulations in this subchapter. Title I of the Act. Official import inspection establishment. Shipping container. The outside con- This term means any establishment, tainer (box, bag, barrel, crate, or other other than an official establishment as receptacle or covering) containing or defined in paragraph (zz) of this sec- wholly or partly enclosing any product tion, where inspections are authorized packed in one or more immediate con- to be conducted as prescribed in § 327.6 tainers. of this subchapter. State. Any State of the United States Official inspection legend. Any symbol or the Commonwealth of Puerto Rico. prescribed by the regulations in this Supervision. The controls, as pre- subchapter showing that an article was scribed in instructions to Program em- inspected and passed in accordance ployees, to be exercised by them over with the Act. particular operations to insure that Official mark. The official inspection such operations are conducted in com- legend or any other symbol prescribed pliance with the Act and the regula- by the regulations in this subchapter tions in this subchapter. to identify the status of any article or Surgical anesthesia. A state of uncon- animal under the Act. sciousness measured in conformity Packaging material. Any cloth, paper, with accepted surgical practices. plastic, metal, or other material used Territory. Guam, the Virgin Islands of to form a container, wrapper, label, or the United States, American Samoa, cover for meat products. and any other territory or possession Person. Any individual, firm, or cor- of the United States, excluding the poration. Canal Zone. Pesticide chemical, food additive, color U.S. Condemned. This term means additive, raw agricultural commodity. that the livestock so identified has These terms shall have the same mean- been inspected and found to be in a ings for purposes of the Act and the dying condition, or to be affected with regulations in this subchapter as under any other condition or disease that the Federal Food, Drug, and Cosmetic would require condemnation of its car- Act. cass. Prepared. Slaughtered, canned, salt- U.S. Inspected and Condemned (or any ed, rendered, boned, cut up, or other- authorized abbreviation thereof). This wise manufactured or processed. term means that the carcass, viscera, Process authority. A person or organi- other part of carcass, or other product zation with expert knowledge in meat so identified has been inspected, found production process control and rel- to be adulterated, and condemned

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under the regulations in this sub- (1) Every establishment, except as chapter. provided in § 303.1 (a) and (b), or (c) of U.S. Passed for Cooking. This term this subchapter, in which any livestock means that the meat or meat byprod- are slaughtered for transportation or uct so identified has been inspected and sale as articles of commerce, or in passed on condition that it be cooked which any products of, or derived from, or rendered as prescribed by the regula- carcasses of livestock are, wholly or in tions in part 315 of this chapter. part, prepared for transportation or U.S. Passed for Refrigeration. This sale as articles of commerce, which are term means that the meat or meat by- intended for use as human food; product so identified has been in- (2) Every establishment, except as spected and passed on condition that it provided in § 303.1 (a) and (b), or (d) of be refrigerated or otherwise handled as this subchapter, within any State or prescribed by the regulations in part organized Territory which is des- 311 of this subchapter. ignated pursuant to paragraph 301(c) of U.S. Retained. This term means that the Act, at which any livestock are the carcass, viscera, other part of car- slaughtered or any products of any cass, or other product, or article so livestock are prepared, for use as identified is held for further examina- human food solely for distribution tion by an inspector to determine its within such jurisdiction; and disposal. (3) Every establishment, except as provided in § 303.1 (a) and (b) of this U.S. Suspect. This term means that subchapter, that is designated by the the livestock so identified is suspected Administrator pursuant to paragraph of being affected with a disease or con- 301(c) of the Act as one producing adul- dition which may require its con- terated products which would clearly demnation, in whole or in part, when endanger the public health. slaughtered, and is subject to further examination by an inspector to deter- [35 FR 15556, Oct. 3, 1970, as amended at 36 FR mine its disposal. 12002, June 24, 1971] United States. The States, the District § 302.2 Application of requirements in of Columbia, and the Territories of the designated States or Territories; United States. and to designated plants endan- [35 FR 15554, Oct. 3, 1970] gering public health. Special provisions with respect to es- EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 301.2, see the List of CFR tablishments and their operations and Sections Affected, which appears in the transactions by any persons in des- Finding Aids section of the printed volume ignated States and Territories and and at www.fdsys.gov. with respect to establishments designated as producing adulterated prod- PART 302—APPLICATION OF IN- ucts which clearly endanger public SPECTION AND OTHER REQUIRE- health, and the operators thereof, in any State or Territory appear in part MENTS 331 of this subchapter, and apply to such establishments, operations and Sec. transactions in lieu of the regulations 302.1 Establishments requiring inspection. elsewhere in this subchapter except in- 302.2 Application of requirements in designated States or Territories; and to des- sofar as such regulations are made ap- ignated plants endangering public plicable by the provisions in part 331 of health. this subchapter. 302.3 Livestock and products entering offi- [35 FR 15556, Oct. 3, 1970, as amended at 51 FR cial establishments. 29909, Aug. 21, 1986] AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, 2.55. § 302.3 Livestock and products entering official establishments. § 302.1 Establishments requiring in- All livestock and all products enter- spection. ing any official establishment and all (a) Inspection under the regulations products prepared, in whole or in part, in this subchapter is required at: therein, shall be inspected, handled,

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stored, prepared, packaged, marked, chapter, regarding water reuse and any and labeled as required by the regula- provisions of part 416 of this chapter tions in this subchapter. relating to inspection or supervision of [35 FR 15556, Oct. 3, 1970] specified activities or other action by a Program employee. If custom operations are conducted in an official es- PART 303—EXEMPTIONS tablishment, however, all of the provisions of part 416 of this chapter of shall Sec. 303.1 Exemptions. apply to those operations. 303.2 Experimentation: Intensity of inspec- (ii) If the custom operator prepares tion coverage. or handles any products for sale, they AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, are kept separate and apart from the 2.55. custom prepared products at all times while the latter are in his custody; § 303.1 Exemptions. (iii) The custom prepared products (a) The requirements of the Act and are plainly marked ‘‘Not for Sale’’ as the regulations in this subchapter for provided in § 316.16 of this subchapter, inspection of the preparation of prod- immediately after being prepared and ucts do not apply to: are kept so identified until delivered to (1) The slaughtering by any indi- the owner; and vidual of livestock of his own raising, (iv) If exempted custom slaughtering and the preparation by him and trans- or other preparation of products is con- portation in commerce of the car- ducted in an official establishment, all casses, parts thereof, meat and meat facilities and equipment in the official food products of such livestock exclu- establishment used for such custom op- sively for use by him and members of erations shall be thoroughly cleaned his household and his nonpaying guests and sanitized before they are used for and employees; preparing any products for sale. (2) The custom slaughter by any per- (b)(1) The exempted custom prepared son of cattle, sheep, swine, or goats de- products shall be prepared and handled livered by the owner thereof for such in accordance with the provisions of slaughter, and the preparation by such §§ 318.5, 318.6, 318.10, 381.300 through slaughterer and transportation in com- 318.311 of this subchapter and § 424.21 of merce of the carcasses, parts thereof, subchapter E, and shall not be adulter- meat and meat food products of such ated as defined in paragraph 1(m) of the livestock, exclusively for use, in the Act. The provisions of §§ 318.5, 318.6, household of such owner, by him and 318.10, and 318.300 through 318.311 re- members of his household and his nonpaying guests and employees; nor to lated to inspection or supervision of the custom preparation by any person specified activities or other action by of carcasses, parts thereof, meat or an inspection program employee and meat food products derived from the the provisions of § 318.6(b)(9) and (10) slaughter by any individual of cattle, shall not apply to the preparation and sheep, swine, or goats of his own rais- handling of such exempted products. ing or from game animals, delivered by (2) The exempted custom prepared the owner thereof for such custom products shall comply with the require- preparation, and transportation in ments of §§ 316.16 and 317.16 of this sub- commerce of such custom prepared ar- chapter. ticles, exclusively for use in the house- (3) The custom operators claiming hold of such owner, by him and mem- exemption under paragraph (a)(2) of bers of his household and his non- this section shall keep records, in addi- paying guests and employees: Provided, tion to records otherwise required by That the following requirements are part 320 of this subchapter, showing the met by such custom operator; numbers and kinds of livestock slaugh- (i) Establishments that conduct cus- tered on a custom basis, the quantities tom operations must be maintained and types of products prepared on a and operated in accordance with the custom basis, and the names and ad- provisions of §§ 416.1 through 416.6, ex- dresses of the owners of the livestock cept for: § 416.2(g)(2) through (6) of this and products.

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(4) Articles capable of use as human (b) Grinding and freezing products food, resulting from the exempted cus- made from meat; tom slaughter or other preparation of (c) Curing, cooking, smoking, ren- products shall be promptly denatured dering or refining of livestock fat, or or otherwise identified in accordance other preparation of products, except with § 325.13 of this subchapter and not slaughtering or the retort processing of removed from the establishment where canned products; the custom operations are conducted (d) Breaking bulk shipments of prod- until so identified, unless they are de- ucts; livered to the owner of the articles for (e) Wrapping or rewrapping products. use in accordance with paragraph (a)(2) (ii) Any quantity or product pur- of this section. chased by a consumer from a particular (c) It has been determined that it is retail supplier shall be deemed to be a impracticable to provide inspection of normal retail quantity if the quantity the preparation of products at estab- so purchased does not in the aggregate lishments in any unorganized Territory exceed one-half carcass. The following at which livestock are slaughtered or amounts of product will be accepted as their products are prepared for dis- representing one-half carcass of the tribution solely within such jurisdic- species identified: tion and that exempting such establishments from requirements of the One-half carcass Act for such inspections under the con- pounds ditions stated in this section will otherwise facilitate enforcement of the Cattle ...... 300 Act. Therefore, such inspection re- Calves ...... 37.5 quirements of the Act and of the regu- Sheep ...... 27.5 Swine ...... 100 lations in this subchapter shall not Goats ...... 25 apply at such establishments if they are operated in accordance with the (iii) A retail store is any place of regulations in part 416, §§ 416.1 through business where: 416.5 of this chapter. However, the Ad- (a) The sales of product are made to ministrator may refuse, withdraw, or consumers only; modify any exemption under this para- (b) At least 75 percent, in terms of graph when he determines in any spe- dollar value, of total sales of product cific case in accordance with the appli- represents sales to household con- cable rules of practice that such action sumers and the total dollar value of is necessary to effectuate the purposes sales of product to consumers other of this Act. than household consumers does not ex- (d)(1) The requirements of the Act ceed the dollar limitation per calendar and the regulations in this subchapter year set by the Administrator. This for inspection of the preparation of dollar limitation is a figure which will products do not apply to operations of automatically be adjusted during the types traditionally and usually con- first quarter of each calendar year, up- ducted at retail stores and restaurants, ward or downward, whenever the Con- when conducted at any retail store or sumer Price Index, published by the restaurant or similar retail-type estab- Bureau of Labor Statistics, Depart- lishment for sale in normal retail ment of Labor, indicates a change in quantities or service of such articles to the price of this same volume of prod- consumers at such establishments. uct which exceeds $500. Notice of the (2) For purposes of paragraph (d)(1) of adjusted dollar limitation will be pub- this section: lished in the FEDERAL REGISTER. 1 (i) Operations of types traditionally and usually conducted at retail stores and restaurants are the following: 1 The dollar limitation currently in effect (a) Cutting up, slicing, and trimming may be obtained by contacting Director, Slaughter Inspection Standards and Proce- carcasses, halves, quarters, or whole- dures Division, Technical Services, Food and sale cuts into retail cuts such as Safety Inspection Service, U.S. Department steaks, chops, and roasts, and freezing of Agriculture, Washington, DC 20250 (202) such cuts; 447–3219.

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(c) Only federally or State inspected are ready to eat when they leave such and passed product is handled or used facility (i.e., no further cooking or in the preparation of any product, ex- other preparation is needed, except cept that product resulting from the that they may be reheated prior to custom slaughter or custom prepara- serving if chilled during transpor- tion of product may be handled or used tation), transported directly to a rein accordance with paragraph (a)(2) and ceiving restaurant by its own employ- (b) of this section but not for sale; ees, without intervening transfer or (d) No sale of product is made in ex- storage, maintained in a safe, unadul- cess of a normal retail quantity as de- terated condition during transpor- fined in paragraph (d)(2)(ii) of this sec- tation, and served in meals or as tion; entrees only to customers at res- (e) The preparation of products for taurants, or through vending ma- sale to household consumers is limited chines, owned or operated by the same to traditional and usual operations as person that owns or operates such fa- defined in paragraph (d)(2)(i) of this cility, and which otherwise meets the section; and requirements of this paragraph: Pro- (f) The preparation of products for vided, That the requirements of §§ 320.1 sale to other than household con- through 320.4 of this subchapter apply sumers is limited to traditional and to such facility. Provided further, That usual operations as defined in para- the exempted facility may be subject graph (d)(2)(i) (a), (b), (d), and (e) of this to inspection requirements under the section. (A retail store at which cus- Act for as long as the Administrator tom slaughtering or preparation of deems necessary, if the Administrator products is conducted is not thereby determines that the sanitary condi- disqualified from exemption as a retail tions or practices of the facility or the store under this paragraph (d).) processing procedures or methods at (iv) Restaurants. (a) A restaurant is the facility are such that any of its any establishment where: meat or meat food products are ren- (1) Product is prepared only for sale dered adulterated. When the Adminis- or service in meals or as entrees di- trator has made such determination rectly to individual consumers at such and subjected a restaurant central establishments; kitchen facility to such inspection re- (2) Only federally or State inspected quirements, the operator of such facil- and passed product or such product ity shall be afforded an opportunity to prepared at a retail store exempted dispute the Administrator’s determina- under paragraph (d)(2)(iii) of this section in a hearing pursuant to rules of tion is handled or used in the prepara- practice which will be adopted for this tion of any product; proceeding. (3) No sale of product is made in ex- (v) Similar retail-type establishment: cess of a normal retail quantity as de- Any establishment which is a combina- fined in paragraph (d)(2)(ii) of this section retail store and restaurant; any tion; and delicatessen which meets the require- (4) The preparation of product is lim- ments for a retail store or restaurant ited to traditional and usual operations as prescribed in paragraphs (d)(2) (iii) as defined in paragraph (d)(2)(i) of this or (iv) of this section; or other estab- section. lishment as determined by the Admin- (b) The definition of a restaurant in- istrator in specific cases. cludes a caterer which delivers or (vi) Consumer: Any household con- serves product in meals, or as entrees, sumer, hotel, restaurant, or similar in- only to individual consumers and oth- stitution as determined by the Admin- erwise meets the requirements of this istrator in specific cases. paragraph. (3) Whenever any complaint is re- (c) For purposes of this paragraph, ceived by the Administrator from any operations conducted at a restaurant person alleging that any retail store central kitchen facility shall be consid- claiming exemption under this para- ered as being conducted at a restaurant graph (d), in any designated State or if the restaurant central kitchen pre- organized Territory that is identified pares meat or meat food products that under section 205 of the Act (as one

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that does not have or is not exercising conduct food service at the public or adequate authority with respect to rec- private nonprofit institution, without ordkeeping requirements) has been op- intervening transfer or storage. erated in violation of the conditions (2) The definitions at Chapter 1, 1–102, prescribed in this section for exemp- except 1–102(z) and the provisions of tion, and the Administrator, upon in- Chapters 2 through 8, except sections 2– vestigation of the complaint, has rea- 102(a) and (b), 2–302(d), 2–403(a), 2–403(c), son to believe that any such violation 2–404, 2–405, 2–407, 2–502 through 2–506, has occurred, he shall so notify the op- 2–508, 2–509, 4–105, 4–201(c), 4–208, 5– erator of the retail store and afford 101(a), 5–103, 5–104, 5–202(c), 5–203, and 6– him reasonable opportunity to present 105, part IV, of the Food and Drug Ad- his views informally with respect to ministration’s Food Service Sanitation the matter. Thereafter, if the Adminis- Manual (1976 Recommendations), trator still has reason to believe that DHEW Publication No. (FDA) 78–2081, such a violation has occurred, and that which is incorporated by reference, a requirement that the operator keep shall apply to the facilities and oper- records concerning the operations of ations of businesses claiming this ex- the retail store would effectuate the emption. (These materials are incor- purposes of the Act, the Administrator porated as they exist on the date of ap- shall order the operator to maintain proval. This incorporation by reference complete, accurate, and legible records was approved by the Director of the of total monthly purchases and of total Federal Register in accordance with 5 monthly sales of meat, meat byprod- U.S.C. 552(a) and 1 CFR part 51. Copies ucts, and meat food products, in terms may be purchased from the Super- of dollar values of the products in- intendent of Documents, U.S. Govern- volved. Such records shall separately ment Printing Office, Washington, DC show total sales to household con- 20402. It is also available for inspection sumers and total sales to other con- at the FSIS Hearing Clerk, room 3171, sumers and shall be maintained for the South Building, Food Safety and In- period prescribed in § 320.3 of this sub- spection Service, U.S. Department of chapter. If the operator maintains cop- Agriculture, Washington, DC 20250, or ies of bills of lading, receiving and shipping invoices, warehouse receipts, at the National Archives and Records or similar documents which give the Administration (NARA). For informa- information required herein, additional tion on the availability of this mate- records are not required by this sub- rial at NARA, call 202–741–6030, or go paragraph. to: http://www.archives.gov/ (e)(1) The requirements of the Act federallregister/ and the regulations in this subchapter codeloflfederallregulations/ for inspection of the preparation of ibrllocations.html. products do not apply to meat pizzas (3) Facilities and operations of busi- containing meat food product ingredi- nesses claiming this exemption shall ents which were prepared, inspected, also conform to the following require- and passed in a cured or cooked form as ments: ready-to-eat (i.e., no further cooking or (i) Manual cleaning and sanitizing. (A) other preparation is needed) in compli- For manual washing, rinsing and sani- ance with the requirements of the Act tizing of utensils and equipment, a sink and these regulations; and the meat with not fewer than three compart- pizzas are to be served in public or pri- ments shall be provided and used. Sink vate nonprofit institutions, provided compartments shall be large enough to that the meat pizzas are ready-to-eat permit the accommodation of the (i.e., no further cooking or other prepa- equipment and utensils, and each com- ration is needed, except that they may partment of the sink shall be supplied be reheated prior to serving if chilled with hot and cold potable running during transportation), transported di- water. Fixed equipment and utensils rectly to the receiving institution by and equipment too large to be cleaned employees of the preparing firm, rein sink compartments shall be washed ceiving institution, or a food service manually or cleaned through pressure management company contracted to spray methods.

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(B) Drain boards or easily movable (5) Treatment with steam free from dish tables of adequate size shall be materials or additives other than those provided for proper handling of soiled specified in 21 CFR 173.310 in the case utensils prior to washing and for of equipment too large to sanitize by cleaned utensils following sanitizing immersion, but in which steam can be and shall be located so as not to inter- confined; or fere with the proper use of the dish- (6) Rinsing, spraying, or swabbing washing facilities. with a chemical sanitizing solution of (C) Equipment and utensils shall be at least twice the strength required for preflushed or prescraped and, when that particular sanitizing solution necessary, presoaked to remove gross under paragraph (e)(3)(i)(E)(4) of this food particles and soil. section in the case of equipment too (D) Except for fixed equipment and large to sanitize by immersion. utensils too large to be cleaned in sink (F) When hot water is used for sani- compartments, manual washing, rins- tizing, the following facilities shall be ing and sanitizing shall be conducted in provided and used: the following sequence: (1) An integral heating device or fix- (1) Sinks shall be cleaned prior to ture installed in, on, or under the sani- use. tizing compartment of the sink capable (2) Equipment and utensils shall be of maintaining the water at a tempera- ° thoroughly washed in the first com- ture of at least 170 F; and partment with a hot detergent solution (2) A numerically scaled indicating ± ° that is kept clean. thermometer, accurate to 3 F, convenient to the sink for frequent checks (3) Equipment and utensils shall be of water temperature; and rinsed free of detergent and abrasives (3) Dish baskets of such size and de- with clean water in the second com- sign to permit complete immersion of partment. the tableware, kitchenware, and equip- (4) Equipment and utensils shall be ment in the hot water. sanitized in the third compartment ac- (G) When chemicals are used for sani- cording to one of the methods pre- tization, they shall not have con- scribed in paragraph (e)(3)(i)(E) (1) centrations higher than the maximum through (4) of this section. permitted under 21 CFR 178.1010 and a (E) The food-contact surfaces of all test kit or other device that accurately equipment and utensils shall be sani- measures the parts per million con- tized by: centration of the solution shall be pro- (1) Immersion for at least 1⁄2 minute vided and used. in clean, hot water at a temperature of (ii) Mechanical cleaning and sanitizing. at least 170 °F; or (A) Cleaning and sanitizing may be (2) Immersion for at least 1 minute in done by spray-type or immersion dish- a clean solution containing at least 50 washing machines or by any other type parts per million of available chlorine of machine or device if it is dem- as a hypochlorite and at a temperature onstrated that it thoroughly cleans of at least 75 °F; or and sanitizes equipment and utensils. (3) Immersion for at least 1 minute in These machines and devices shall be a clean solution containing at least 12.5 properly installed and maintained in parts per million of available iodine good repair. and having a pH not higher than 5.0 Machines and devices shall be oper- and at a temperature of at least 75 °F; ated in accordance with manufactur- or ers’ instructions, and utensils and (4) Immersion in a clean solution equipment placed in the machine shall containing any other chemical sani- be exposed to all dishwashing cycles. tizing agent allowed under 21 CFR Automatic detergent dispensers, wet- 178.1010 that will provide the equiva- ting agent dispensers, and liquid sani- lent bactericidal effect of a solution tizer injectors, if any, shall be properly containing at least 50 parts per million installed and maintained. of available chlorine as a hypochlorite (B) The pressure of final rinse water at a temperature of at least 75 °F for 1 supplied to spray-type dishwashing ma- minute; or chines shall not be less than 15 nor

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more than 25 pounds per square inch (2) The wash water shall be kept measured in the water line imme- clean. diately adjacent to the final rinse con- (3) Chemicals added for sanitization trol valve. A 1⁄4–inch IPS valve shall be purposes shall be automatically dis- provided immediately up stream from pensed. the final rinse control valve to permit (4) Utensils and equipment shall be checking the flow pressure of the final exposed to the final chemical sani- rinse water. tizing rinse in accordance with manu- (C) Machine or water line mounted facturers’ specifications for time and numerically scaled indicating ther- concentration. mometers, accurate to ±3 °F, shall be (5) The chemical sanitizing rinse provided to indicate the temperature of water temperature shall be not less ° the water in each tank of the machine than 75 F nor less than the tempera- and the temperature of the final rinse ture specified by the machine’s manu- water as it enters the manifold. facturer. (6) Chemical sanitizers used shall (D) Rinse water tanks shall be pro- meet the requirements of 21 CFR tected by baffles, curtains, or other ef- 178.1010. fective means to minimize the entry of (7) A test kit or other device that ac- wash water into the rinse water. Con- curately measures the parts per mil- veyors in dishwashing machines shall lion concentration of the solution shall be accurately timed to assure proper be available and used. exposure times in wash and rinse cy- (H) Machines using hot water for cles in accordance with manufacturers’ sanitizing may be used provided that specifications attached to the ma- wash water and pumped rinse water chines. shall be kept clean and water shall be (E) Drain boards shall be provided maintained at not less than the fol- and be of adequate size for the proper lowing temperatures: handling of soiled utensils prior to (1) Single-tank, stationary-rack, washing and of cleaned utensils fol- dual-temperature machine: lowing sanitization and shall be so located and constructed as not to inter- Wash temperature ...... 150 °F fere with the proper use of the dish- Final rinse temperature ...... 180 °F washing facilities. This does not pre- (2) Single-tank, stationary-rack, sin- clude the use of easily movable dish ta- gle-temperature machine: bles for the storage of soiled utensils or ° the use of easily movable dishtables for Wash temperature ...... 165 F Final rinse temperature ...... 165 °F the storage of clean utensils following sanitization. (3) Single-tank, conveyor machine: (F) Equipment and utensils shall be Wash temperature ...... 160 °F flushed or scraped and, when necessary, Final rinse temperature ...... 180 °F soaked to remove gross food particles (4) Multitank, conveyor machine: and soil prior to being washed in a dishwashing machine unless a Wash temperature ...... 150 °F prewashcycle is a part of the dish- Pumped rinse temperature ...... 160 °F ° washing machine operation. Equipment Final rinse temperature ...... 180 F and utensils shall be placed in racks, (5) Single-tank, pot, pan, and utensil trays, or baskets, or on conveyors, in a washer (either stationary or moving- way that food-contact surfaces are ex- rack): posed to the unobstructed application Wash temperature ...... 140 °F of detergent wash and clean rinse wa- Final rinse temperature ...... 180 °F ters and that permits free draining. (I) All dishwashing machines shall be (G) Machines (single-tank, sta- thoroughly cleaned at least once a day tionary-rack, door-type machines and or more often when necessary to main- spray-type glass washers) using chemi- tain them in a satisfactory operating cals for sanitization may be used: Pro- condition. vided, That, (iii) Steam. Steam used in contact (1) The temperature of the wash with food or food-contact surfaces shall water shall not be less than 120 °F. be free from any materials or additives

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other than those specified in 21 CFR action is, therefore, necessary to pro- 173.310. tect the public health, interest or safe- (4) For purposes of this paragraph, ty. Such withdrawal or modification the term ‘‘private nonprofit institu- shall be effective upon oral or written tion’’ means ‘‘a corporation, and any notification, whichever is earlier, to community chest, fund, or foundation, the owner or operator of the particular organized and operated exclusively for establishment as promptly as cir- religious, charitable, scientific, testing cumstances permit. In the event of oral for public safety, literary, or edu- notification, written confirmation cational purposes, or to foster national shall be given to the owner or operator or international amateur sports com- petition (but only if no part of its ac- of the establishment as promptly as tivities involve the provision of ath- circumstances permit. This withdrawal letic facilities or equipment), or for the or modification shall continue in effect prevention of cruelty to children or ending the completion of the pro- animals, no part of the net earnings of ceeding and any judicial review there- which inures to the benefit of any pri- of, unless otherwise ordered by the Ad- vate shareholder or individual, no sub- ministrator. stantial part of the activities of which (f) The adulteration and misbranding is carrying on propaganda, or other- provisions of the Act and the regula- wise attempting, to influence legisla- tions in this subchapter, other than the tion, and which does not participate in, requirement of the official inspection or intervene in (including the pub- legend, apply to articles which are ex- lishing or distribution of statements), empted from inspection or not required any political campaign on behalf of (or to be inspected under this section. This in opposition to) any candidate for pub- includes the requirement that any pork lic office.’’ and any product containing pork be (5) The Administrator may withdraw prepared only in compliance with any or modify the exemption set forth in § 303.1(e)(1) for a particular establish- applicable requirement for the destruc- ment when he or she determines that tion of trichina as provided in § 318.10 of such action is necessary to ensure food this subchapter. safety and public health. Before such (g) The Administrator may extend action is taken, the owner or operator the requirements of titles I and IV of of the particular establishment shall be the Act to any establishment in any notified, in writing, of the reasons for State or organized Territory at which the proposed action and shall be given products are prepared for distribution an opportunity to respond, in writing, solely within such jurisdiction, if he to the Administrator within 20 days determines in accordance with the pro- after notification of the proposed ac- visions of paragraph 301(c)(1) of the Act tion. The written notification shall be that it is producing adulterated prod- served on the owner or operator of the ucts which would clearly endanger the establishment in the manner pre- public health. scribed in section 1.147(b) of the De- (h) The Administrator may in spe- partment’s Uniform Rules of Practice cific classes of cases waive for limited (7 CFR 1.147(b)). In those instances where there is conflict of any material periods any provisions of the regula- fact, the owner or operator of the es- tions in this subchapter in order to per- tablishment, upon request, shall be af- mit appropriate and necessary action forded an opportunity for a hearing in the event of a public health emer- with respect to the disputed fact, in ac- gency or to permit experimentation so cordance with rules of practice which that new procedures, equipment, and/or shall be adopted for the proceeding. processing techniques may be tested to However, such withdrawal or modifica- facilitate definite improvements: Pro- tion shall become effective pending vided, That such waivers of the provi- final determination in the proceeding sions of such regulations are not in when the Administrator determines that an imminent threat to food safety or public health exists, and that such

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conflict with the purposes or provisions (1) In assessing the performance of an of the Act. establishment, the following factors are appropriate for consideration: (Approved by the Office of Management and Budget under control number 0583–0015) (i) The history of compliance with applicable regulatory requirements by [35 FR 15558, Oct. 3, 1970, as amended at 36 FR the person conducting operations at 12002, 12004, June 24, 1971; 45 FR 27922, Apr. 25, such establishment or by anyone re- 1980; 46 FR 46288, Sept. 18, 1981; 47 FR 746, Jan. 7, 1982; 51 FR 29909, Aug. 21, 1986; 52 FR sponsibly connected with the business 10032, Mar. 30, 1987; 52 FR 48091, Dec. 18, 1987; conducting operations at such estab- 53 FR 24679, June 30, 1988; 57 FR 34182, Aug. lishment, as ‘‘responsibly connected’’ 3, 1992; 64 FR 56415, Oct. 20, 1999; 76 FR 82078, is defined in section 401(g) of the Act, Dec. 30, 2011] (ii) The competence of the person conducting operations at such estab- § 303.2 Experimentation: Intensity of lishment, as indicated by: inspection coverage. (A) Knowledge of appropriate manu- (a) Pursuant to the Processed Prod- facturing practices and applicable reg- ucts Inspection Improvement Act of ulatory requirements, 1986, Title IV of the Futures Trading (B) Demonstrated ability to apply Act of 1986 (Pub. L. 99–641), in estab- such knowledge in a timely and con- lishments preparing products at which sistent manner, and inspection under the Act and regula- (C) Commitment to correcting defi- tions is required, the frequency with ciencies noted by Program employees which and the manner in which meat and otherwise assuring compliance food products made from livestock pre- with applicable regulatory require- viously slaughtered in official estab- ments, and lishments are examined and inspected (iii) The procedures used in such es- by Program employees is to be based tablishment to control the production on considerations relevant to effective process, environment, and resulting regulation of meat food products and product in order to assure and monitor protection of the health and welfare of compliance with the requirements of consumers. In order to test procedures the Act and the rules and regulations for use in making such determinations promulgated thereunder. and, in particular, for determining (2) In assessing the characteristics of whether and, is so, to what extent the an establishment, the following factors intensity of inspection coverage ex- are appropriate for consideration: ceeds that which should be considered (i) The complexity of the processing necessary pursuant to section 6 of the operation(s) conducted at such estab- Act, as amended by section 403(a) of lishment, the Futures Trading Act of 1986, the (ii) The frequency with which each Administrator is initiating experimen- such operation is conducted at such es- tation of a new system of inspection tablishment, for reviewing the performance of estab- (iii) The volume of product resulting lishments and for designing the super- from each such operation at such es- vision and other conditions and meth- tablishment, ods of inspection coverage. For the pe- (iv) Whether and to what extent riod of such experimentation, the Ad- slaughter operations also are con- ministrator shall identify establish- ducted at such establishment, ments for review, and the frequency (v) What, if any, food products not and the manner of inspection by Pro- regulated under this Act or the Poultry gram employees shall be determined on Products Inspection Act also are pre- the basis of the results of those reviews pared at such establishment, and and be otherwise in accordance with (vi) The size of such establishment. this section. (c)(1) For the period of experimen- (b) The determinations referred to in tation described in paragraph (a) of paragraph (a) of this section shall be this section, the frequency of inspec- made by the program and shall reflect tion by Program employees of oper- evaluations of the performance and the ations other than slaughter may be re- characteristics and such establish- duced in an establishment in which the ments. procedures referred to therein are

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being tested if and only if the evalua- 304.3 Conditions for receiving inspection. tion of the performance of such estab- AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.18, lishment described in paragraph (b)(1) 2.53. indicates that there are: (i) No instances, documented in § 304.1 Application for inspection. records compiled no earlier than 10 (a) Before the inspection is granted, years before, of substantial and recent each person conducting operations at noncompliance with applicable regu- an establishment subject to the Act, latory requirements (taking into ac- whether tenant, subsidiary, or land- count both the nature and frequency of lord, shall make application therefor any such noncompliance), and to the Administrator as provided for in (ii) The competence and control pro- this part. cedures needed to assure and monitor compliance with applicable regulatory (b) Every application under this sec- requirements. tion shall be made on an official form (2)(i) The frequency of Federal in- furnished by the Program, available spection and other conditions and from any Regional Director identified methods of inspection coverage in any in § 301.2(kkk) of this subchapter, and establishment in which the frequency shall be completed to include all infor- of Federal inspection is reduced shall mation requested. Trade names of the be based on: applicant for labeling purposes, shall (A) The evaluation of the character- be inserted in the appropriate blank in istics of such establishment described the application. Each applicant for in- in paragraph (b)(2) of this section, 1 spection will be held responsible for (B) The significance of potential pub- compliance with the Act and the regu- lic health consequences of noncompli- lations in this subchapter if inspection ance, and is granted. Preparation of product and (C) The availability of Program em- other operations at the establishment ployees. for which inspection is granted may be (ii) To the extent that such frequency conducted only by the applicant named of inspection or other conditions and in the application. methods of inspection coverage are (c) In cases of change of ownership or identified as conflicting with provi- location, a new application shall be sions of the regulations in this sub- made. chapter, the Administrator will waive [40 FR 2575, Jan. 14, 1975, as amended at 53 such provisions for the period of experi- FR 49848, Dec. 12, 1988] mentation, in accordance with § 303.1(g) of this subchapter. § 304.2 Information to be furnished; [52 FR 10032, Mar. 30, 1987 and 52 FR 48091, grant or refusal of inspection. Dec. 18, 1987] (a) FSIS shall give notice in writing to each applicant granted inspection PART 304—APPLICATION FOR IN- and shall specify in the notice the es- SPECTION; GRANT OF INSPEC- tablishment, including the limits of TION the establishment’s premises, to which the grant pertains. Sec. (b) The Administrator is authorized 304.1 Application for inspection. to grant inspection upon his deter- 304.2 Information to be furnished; grant or mination that the applicant and the es- refusal of inspection. tablishment are eligible therefor and to refuse to grant inspection at any es- 1 These evaluations will be based upon tablishment if he determines that it guidelines developed by FSIS and the com- does not meet the requirements of this plexity categorization in FSIS Directive part or the regulations in parts 305, 307, 1030.2 (Documentation of Processing and and part 416, §§ 416.1 through 416.6 of Combination Assignments, 4/22/85). The this chapter or that the applicant has guidelines and Directive will be available for public inspection and copying in the Policy not received approval of labeling and Office, Room 3168, South Agriculture Build- containers to be used at the establishing, 14th Street and Independence Avenue, ment as required by the regulations in SW., Washington, DC. parts 316 and 317. Any application for

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inspection may be refused in accord- § 304.3 Conditions for receiving in- ance with the rules of practice in part spection. 500 of this chapter. (a) Before being granted Federal in- (c)(1) Any applicant for inspection at spection, an establishment shall have an establishment where the operations developed written sanitation Standard thereof may result in any discharge Operating Procedures, as required by into the navigable waters in the United part 416 of this chapter. States is required by subsection 21(b) of (b) Before being granted Federal in- the Federal Water Pollution Control spection, an establishment shall have Act, as amended (84 Stat. 91), to pro- conducted a hazard analysis and devel- vide the Administrator with a certifi- oped and validated a HACCP plan, as cation as prescribed in said subsection required by §§ 417.2 and 417.4 of this that there is reasonable assurance that chapter. A conditional grant of inspec- such activity will be conducted in a tion shall be issued for a period not to manner which will not violate the ap- exceed 90 days, during which period the plicable water quality standards. No establishment must validate its grant of inspection can be issued after HACCP plan. April 3, 1970 (the date of enactment of (c) Before producing new product for the Water Quality Improvement Act), distribution in commerce, an establish- unless such certification has been ob- ment shall have conducted a hazard tained, or is waived because of failure analysis and developed a HACCP plan or refusal of the State, interstate agen- applicable to that product in accordance with § 417.2 of this chapter. During cy or the Secretary of the Interior to a period not to exceed 90 days after the act on a request for certification with- date the new product is produced for in a reasonable period (which shall not distribution in commerce, the estab- exceed 1 year after receipt of such re- lishment shall validate its HACCP quest). plan, in accordance with § 417.4 of this (2) However, certification is not ini- chapter. tially required in connection with an application for inspection granted after [61 FR 38864, July 25, 1996] April 3, 1970, for facilities existing or under construction on April 3, 1970, al- PART 305—OFFICIAL NUMBERS; IN- though certification for such facilities AUGURATION OF INSPECTION; is required to be obtained within the 3- WITHDRAWAL OF INSPECTION; year period immediately following REPORTS OF VIOLATION April 3, 1970. Failure to obtain such certification and meet the other re- Sec. quirements of subsection 21(b) prior to 305.1 Official numbers; subsidiaries and ten- April 3, 1973, will result in the termi- ants. nation of inspection at such facilities 305.2 Separation of official establishments. on that date. 305.3 Sanitation and adequate facilities. 305.4 Inauguration of inspection. Further, any application for inspection 305.6 Reports of violations. pending on April 3, 1970, and granted AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, within 1 year thereafter shall not re- 2.55. quire certification for 1 year following the grant of inspection but such grant SOURCE: 35 FR 15559, Oct. 3, 1970, unless otherwise noted. of inspection shall terminate at the end of 1 year after its issuance unless § 305.1 Official numbers; subsidiaries prior thereto such certification has and tenants. been obtained and the other require- (a) An official number shall be as- ments of subsection 21(b) are met. signed to each establishment granted [35 FR 15558, Oct. 3, 1970, as amended at 41 FR inspection. Such number shall be used 4889, Feb. 3, 1976; 44 FR 68813, Nov. 30, 1979; 62 to identify all inspected and passed FR 45024, Aug. 25, 1997; 64 FR 56415, Oct. 20, products prepared in the establish- 1999; 64 FR 66545, Nov. 29, 1999; 65 FR 2284, ment. More than one number shall not Jan. 14, 2000] be assigned to an establishment.

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(b) Two or more official establish- § 305.3 Sanitation and adequate facili- ments under the same ownership or ties. control may be granted the same offi- Inspection shall not be inaugurated if cial number, provided a serial letter is an establishment is not in a sanitary added in each case to identify each es- condition nor unless the establishment tablishment and the products thereof. agrees to maintain a sanitary condi- (c) When inspection has been granted tion and provides adequate facilities to any applicant at an establishment, for conducting such inspection. it shall not be granted to any other person at the same establishment. § 305.4 Inauguration of inspection. However, persons operating as separate When inspection is granted, the cir- entities in the same building or struc- cuit supervisor shall, at or prior to the ture may operate separate establish- inauguration of inspection, inform the ments therein only under their own operator of the establishment of the re- grant of inspection. All such persons quirements of the regulations in this operating separate establishments in subchapter. If the establishment, at the same building or structure shall be the time inspection is inaugurated, contains any product which has not responsible for compliance with the theretofore been inspected, passed, and Act and regulations in their own estab- marked in compliance with the regula- lishments, which shall include common tions in this subchapter, the identity of areas, e.g., hallways, stairways, and the same shall be maintained, and it elevators. shall not be distributed in commerce, [35 FR 15559, Oct. 3, 1970, as amended at 40 FR or otherwise subject to the require- 2576, Jan. 14, 1975] ments of such regulations, or dealt with as inspected and passed under the § 305.2 Separation of official establish- regulations. The establishment shall ments. adopt and enforce all necessary meas- (a) Each official establishment shall ures and shall comply with all such di- be separate and distinct from any unof- rections as the circuit supervisor may ficial establishment except a poultry prescribe, for carrying out the purposes of this section. products processing establishment operated under Federal inspection under § 305.6 Reports of violations. the Poultry Products Inspection Act or Program employees shall report, in a under State inspection. manner prescribed by the Adminis- (b) The slaughter or other prepara- trator, all violations of the Act or reg- tion of products of horses, mules, or ulations in this subchapter of which other equines required to be conducted they have information. under inspection pursuant to the regulations in this subchapter shall be done PART 306—ASSIGNMENT AND AU- in establishments separate from any THORITIES OF PROGRAM EM- establishment in which cattle, sheep, swine, or goats are slaughtered or their PLOYEES products are prepared. Sec. (c) Inspection shall not be inaugu- 306.1 Designation of circuit supervisor and rated in any building, any part of assistants. which is used as living quarters, unless 306.2 Program employees to have access to the part for which inspection is re- establishments. quested is separated from such quar- 306.3 Badge as identification of inspectors. 306.4 Assignment of Program employees ters by floors, walls, and ceilings of where members of family employed; so- solid concrete, brick, wood, or similar liciting employment; procuring product material, and the floors, walls, and from official establishments. ceilings are without openings that di- 306.5 Appeals. rectly or indirectly communicate with AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.7, any part of the building used as living 2.18, 2.53. quarters. SOURCE: 35 FR 15559, Oct. 3, 1970, unless otherwise noted.

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§ 306.1 Designation of circuit super- price paid by such employee is the visor and assistants. same as the price paid by the general [See §§ 300.3 and 300.4 of this chapter public. Program employees must pay, regarding FSIS’ organization and in- and obtain receipts for money paid to spection program supervisors.] such establishments for all such product and keep such receipts subject to [69 FR 254, Jan. 5, 2004] inspection by supervisory employees or other authorized Department employ- § 306.2 Program employees to have access to establishments. ees. [See § 300.6 of this chapter regarding § 306.5 Appeals. access to establishments and other places of business.] Any appeal from a decision of any Program employee shall be made to [69 FR 254, Jan. 5, 2004] his/her immediate supervisor having jurisdiction over the subject matter of § 306.3 Badge as identification of in- the appeal, except as otherwise pro- spectors. vided in the applicable rules of prac- Each inspector will be furnished with tice. a numbered official badge, which he shall not allow to leave his possession, [48 FR 11418, Mar. 18, 1983, as amended at 60 and which he shall wear in such man- FR 67454, Dec. 29, 1995] ner and at such times as the Adminis- trator may prescribe. PART 307—FACILITIES FOR [35 FR 15559, Oct. 3, 1970, as amended at 69 FR INSPECTION 254, Jan. 5, 2004] Sec. § 306.4 Assignment of Program em- 307.1 Facilities for Program employees. ployees where members of family 307.2 Other facilities and conditions to be employed; soliciting employment; provided by the establishment. procuring product from official es- 307.3 Inspectors to furnish and maintain im- tablishments. plements in a sanitary condition. (a) Except as specifically authorized 307.4 Schedule of operations. by the Administrator, no Program em- 307.5 Overtime and holiday inspection serv- ployee shall be detailed for duty at an ice. establishment where any member of 307.6 Basis of billing for overtime and holiday services. his family is employed by the operator 307.7 Safety requirements for electrical of the establishment, or any tenant or stimulating (EST) equipment. subsidiary of such operator nor shall any circuit supervisor or other em- AUTHORITY: 7 U.S.C. 394, 21 U.S.C. 601–695; 7 ployee acting in a supervisory capacity CFR 2.17, 2.55. be continued on duty at a circuit where SOURCE: 35 FR 15560, Oct. 3, 1970, unless any member of his family is so em- otherwise noted. ployed at any establishment under his jurisdiction. Program employees are § 307.1 Facilities for Program employ- forbidden to solicit, for any person, em- ees. ployment at any official establish- Office space, including necessary fur- ment, or by any officer, manager, or nishings, light, heat, and janitor serv- employee thereof. ice, shall be provided by official estab- (b) Program employees shall not pro- lishments, rent free, for the exclusive cure product from any official estab- use for official purposes of the inspec- lishment or any other establishment if tor and other Program employees as- its operations or products are inspected signed thereto. The space set aside for or regulated under the Poultry Prod- this purpose shall meet with approval ucts Inspection Act or the Agricultural of the circuit supervisor and shall be Marketing Act of 1946, as amended, or conveniently located, properly venti- any other law administered by the De- lated and provided with lockers suit- partment unless the store or outlet able for the protection and storage of from which the purchase is made is Program supplies and with facilities open to the general public and the suitable for Program employees to

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change clothing if such clothes chang- eased carcasses and parts, so con- ing facilities are deemed necessary by structed as to be readily cleaned; such the circuit supervisor. At the discre- trucks or receptacles to be marked in a tion of the Administrator, small plants conspicuous manner with the phrase requiring the services of less than one ‘‘U.S. condemned’’ in letters not less full time inspector need not furnish fa- than 2 inches high, and, when required cilities for Program employees as pre- by the circuit supervisor, to be scribed in this section, where adequate equipped with facilities for locking or facilities exist in a nearby convenient sealing; location. Laundry service for inspec- (f) Adequate arrangements, including tors’ outer work clothing shall be pro- liquid soap and cleansers, for cleansing vided by each establishment. and disinfecting hands, for sterilizing all implements used in dressing dis- § 307.2 Other facilities and conditions eased carcasses, floors, and such other to be provided by the establish- articles and places as may be contami- ment. nated by diseased carcasses or other- When required by the circuit super- wise; visor, the following facilities and con- (g) In establishments in which ditions, and such others as may be slaughtering is done, rooms, compart- found to be essential to efficient con- ments, or specially prepared open duct of inspection and maintenance of places, to be known as ‘‘final inspec- sanitary conditions, shall be provided tion places,’’ at which the final inspec- by each official establishment: tion of retained carcasses may be con- (a) Satisfactory pens, equipment, and ducted (competent assistants for han- assistants for conducting ante-mortem dling retained carcasses and parts shall inspection and for separating, marking be provided by the establishment; final and holding apart from passed live- inspection places shall be adequate in stock those marked ‘‘U.S. suspect’’ and size and their rail arrangement and those marked ‘‘U.S. condemned’’ (pens, other equipment shall be sufficient to alleys, and runways shall be paved, prevent carcasses and parts passed for drained, and supplied with adequate food or cooking, from being contami- hose connections for cleanup purposes); nated by contact with condemned car- (b) Sufficient light to be adequate for casses or parts; they shall be equipped proper conduct of inspection; with hot water, lavatory, sterilizer, ta- (c) Racks, receptacles, or other suit- bles, and other equipment required for able devices for retaining such parts as ready, efficient, and sanitary conduct the head, tongue, tail, thymus gland, of the inspection; the floors shall be of and viscera, and all parts and blood to such construction as to facilitate the be used in the preparation of meat food maintenance of sanitary conditions products or medical products, until and shall have proper drainage connec- after the post-mortem examination is tions, and when the final inspection completed, in order that they may be place is part of a larger floor, it shall identified in case of condemnation of be separated from the rest of the floor the carcass; equipment, trucks, and re- by a curb, railing, or otherwise); ceptacles for the handling of viscera of (h) Retention rooms, cages, or other slaughtered animals so as to prevent compartments, and receptacles in contact with the floor; and trucks, which carcasses and product may be racks, marked receptacles, tables, and held for further inspection (these shall other necessary equipment for the sep- be in such number and in such loca- arate and sanitary handling of car- tions as the needs of the inspection in casses or parts passed for cooking; the establishment may require; they (d) Tables, benches, and other equip- shall be equipped for secure locking or ment on which inspection is to be per- sealing and shall be held under locks or formed, of such design, material, and official seals furnished by the Depart- construction as to enable Program em- ment; the keys of such locks shall not ployees to conduct their inspection in a leave the custody of Program employ- ready, efficient and clean manner; ees. Every such room, compartment, or (e) Watertight metal trucks or recep- receptacle shall be marked conspicu- tacles for holding and handling dis- ously with the phrase ‘‘U.S. retained’’

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in letters not less than 2 inches high; spector’s work area. In addition, for rooms or compartments for these pur- each head and viscera inspector on cat- poses shall be secure and susceptible of tle slaughter lines, and each head in- being kept clean, including a sanitary spector on swine slaughter lines, a disposal of the floor liquids; establish- sterilizer located adjacent to the in- ment employees shall not enter any re- spector’s work area. tention rooms or compartments or (4) For mechanized operations, a line open any retention receptacles unless control switch located adjacent to each authorized by Program employees); inspection station. (i) Adequate facilities, including de- (5) Facilities to position tally sheets naturing materials, for the proper dis- or other recording devices, such as dig- posal of condemned articles in accord- ital counters, and facilities to contain ance with the regulations in this sub- condemned brands. chapter (tanks or other rendering (6) For swine slaughter lines requir- equipment which, under the regula- ing three or more inspectors, and for tions in this subchapter, must be those one- and two-inspector configura- sealed, shall be properly equipped for tions where the establishment installs sealing as specified by the regulations a mirror: At the carcass inspection sta- in part 314 of this subchapter or by the tion one glass or plastic, distortion- circuit supervisor in specific cases); free mirror, at least 5 feet × 5 feet, (j) Docks and receiving rooms, to be mounted far enough away from the designated by the operator of the offi- vertical axis of the moving line to cial establishment, with the circuit su- allow the carcass to be turned, but not pervisor, for the receipt and inspection over 3 feet away, and so mounted that of all products as provided in § 318.3 of any inspector standing at the carcass this subchapter. inspection station can readily view the (k) Suitable lockers in which brands back of the carcass. bearing the official inspection legend and other official devices (excluding la- [35 FR 15560, Oct. 3, 1970, as amended at 47 FR 33676, Aug. 4, 1982; 50 FR 19902, May 13, 1985; bels) and official certificates shall be 64 FR 56415, Oct. 20, 1999] kept when not in use (all such lockers shall be equipped for sealing or locking § 307.3 Inspectors to furnish and main- with locks or seals to be supplied by tain implements in a sanitary con- the Department; the keys of such locks dition. shall not leave the custody of Program Inspectors shall furnish their own employees); work clothing and implements, such as (l) Sanitary facilities and accom- flashlights and triers, for conducting modations as prescribed by § 416.2(c), inspection and shall maintain their im- (d), (e), (f), and (h) of this chapter. plements in sanitary condition as pre- (m) In addition to any facilities re- scribed by § 416.3(a) of this chapter. quired to accomplish sanitary dressing procedures, the following inspection [64 FR 56415, Oct. 20, 1999] station facilities for cattle and swine slaughter lines described in § 310.1(b) of § 307.4 Schedule of operations. this subchapter are required: (a) No operations requiring inspec- (1) An inspection station consisting tion shall be conducted except under of 5 feet of unobstructed line space for the supervision of a Program employee. each head or carcass inspector and, for All slaughtering of animals and prepa- viscera table kills, 8 feet for each ration of products shall be done with viscera inspector on the inspector’s reasonable speed, considering the offi- side of the table. cial establishment’s facilities. (2) A minimum of 50 foot candles of (b) A shift is a regularly scheduled shadow-free lighting at the inspection operating period, exclusive of meal- surfaces of the head, viscera, and car- time. One lunch period is the only offi- cass. cial authorized interruption in the in- (3) A handwash lavatory (other than spector’s tour of duty once it begins. one which is hand operated), furnished Lunch periods may be 30 minutes, 45 with soap, towels, and hot and cold minutes, or in any case may not exceed water, and located adjacent to the in- one hour in duration. Once established,

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the lunch period must remain rel- given, the area supervisor shall take atively constant as to time and dura- into account the efficient and effective tion. Lunch periods for inspectors shall use of inspection personnel. The work not, except as provided herein, occur schedule must specify daily clock prior to 4 hours after the beginning of hours of operation and lunch periods scheduled operations nor later than 5 for all departments of the establish- hours after operations begin. In plants ment requiring inspection. where a company rest break of not less (2) Establishments shall maintain than 30 minutes is regularly observed, consistent work schedules. Any request approximately midpoint between start by an establishment for a change in its of work and the lunch period, and the work schedule involving an addition or inspector is allowed this time to meet elimination of shifts shall be submitted his personal needs, the lunch period to the area supervisor at least 2 weeks may be scheduled as long as 51⁄2 hours in advance of the proposed change. Fre- after the beginning of scheduled oper- quent requests for change shall not be ations. approved: Provided, however, minor de- (c) Official establishments, import- viations from a daily operating sched- ers, and exporters shall be provided in- ule may be approved by the inspector spection service, without charge, up to in charge, if such request is received on 8 consecutive hours per shift during the the day preceding the day of change. basic workweek subject to the provi- (3) Request for inspection service sions of § 307.5: Provided, That any addi- outside an approved work schedule tional shifts meet requirements as de- shall be made as early in the day as termined by the Administrator or his possible for overtime work to be per- designee. The basic workweek shall formed within that same workday; or consist of 5 consecutive 8-hour days made prior to the end of the day’s oper- within the administrative workweek ation when such a request will result in Sunday through Saturday, and shall overtime service at the start of the fol- include the time for FSIS inspection lowing day: Provided, That an inspector program personnel to put on required may be recalled to his assignment after gear and to walk to a work station, and completion of his daily tour of duty the time for FSIS inspection program under the provisions of § 307.6(b). personnel to return from a work station and remove required gear, exclud- [40 FR 45799, Oct. 3, 1975, as amended at 40 FR ing the lunch period; except that, when 50719, Oct. 31, 1975; 41 FR 15401, Apr. 13, 1976; possible, the Department shall sched- 48 FR 6893, Feb. 16, 1983; 51 FR 32304, Sept. 11, ule the basic workweek so as to consist 1986; 76 FR 33980, June 10, 2011] of 5 consecutive 8-hour days Monday through Friday, and shall include the § 307.5 Overtime and holiday inspection service. time for FSIS inspection program personnel to put on required gear and to (a) The management of an official es- walk to a work station, and the time tablishment, an importer, or an ex- for FSIS inspection program personnel porter shall reimburse the Program, at to return from a work station and re- the rate specified in § 391.3, for the cost move required gear, excluding the of the inspection service furnished on lunch period. The Department may de- any holiday as specified in paragraph part from the basic workweek in those (b) of this section; or for more than 8 cases where maintaining such a sched- hours on any day, or more than 40 ule would seriously handicap the De- hours in any administrative workweek partment in carrying out its function. Sunday through Saturday. These provisions are applicable to all (b) Holidays for Federal employees official establishments except in cer- shall be New Year’s Day, January 1; tain cases as provided in § 318.4(h) of Birthday of Martin Luther King, Jr., this subchapter. the third Monday in January; Washing- (d)(1) Each official establishment ton’s Birthday, the third Monday in shall submit a work schedule to the February; Memorial Day, the last Mon- area supervisor for approval. In consid- day in May; Independence Day, July 4; eration of whether the approval of an Labor Day, the first Monday in Sep- establishment work schedule shall be tember; Columbus Day, the second

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Monday in October; Veterans’ Day, No- tion and is separate from the equip- vember 11; Thanksgiving Day, the ment used to apply the voltage to the fourth Thursday in November; Christ- carcass. The voltage is applied by in- mas Day, December 25. When any of serting a probe that penetrates the car- the above-listed holidays falls outside cass or is inserted in the rectum, plac- the basic workweek, the nearest working a clamp in the nose, a carcass rub- day within that week shall become a bar, a conveyor with energized surfaces holiday. traveling with the carcass, or any [40 FR 45800, Oct. 3, 1975, as amended at 43 FR other acceptable method. 51754, Nov. 7, 1978; 50 FR 724, Jan. 7, 1985; 50 (b) Safety requirements—(1) Circuits, FR 51513, Dec. 18, 1985; 52 FR 4, Jan. 2, 1987; grounding. Either a bonded grounding 53 FR 13397, Apr. 22, 1988; 54 FR 6389, Feb. 10, conductor shall lead from each section 1989] of the carcass rail within the stimu- § 307.6 Basis of billing for overtime lating enclosure to the service ground, and holiday services. or the secondary voltage (stimulating (a) Each recipient of overtime or hol- circuit) shall be insulated from the iday inspection service, or both, shall service ground. If the stimulating sec- be billed as provided for in § 307.5(a) and tion of the carcass rail and carcass at the rates specified in § 391.3, in incre- drive mechanisms are insulated from ments of quarter hours. For billing the service ground then the stimu- purposes, 8 or more minutes shall be lating rail or the return path shall be considered a full quarter hour. Billing electrically bonded to the transformer will be for each quarter hour of service secondary to isolate the stimulation rendered by each Program employee. voltage. (b) Official establishments, import- (2) Enclosure. Electrical stimulation ers, or exporters requesting and receiv- shall occur in an area that will prevent ing the services of a Program employee persons from contacting an energized after he has completed his day’s assign- surface. If the area is surrounded by ment and left the premises, or called physical barriers, the enclosure shall back to duty during any overtime or be either electrically grounded or it holiday period, shall be billed for a shall be made of materials that do not minimum of 2 hours overtime or holi- conduct electricity. The interior of the day inspection service at the estab- stimulating area shall be visible from lished rate. the start switch so the operator can be (c) Bills are payable upon receipt and assured that there is no person, equip- become delinquent 30 days from the ment or material present that should date of the bill. Overtime or holiday inspection will not be performed for any- not be there prior to starting the stim- one having a delinquent account. ulating sequence. If light or sound beam sensors form the enclosure, the [40 FR 45800, Oct. 3, 1975, as amended at 54 FR stimulating equipment shall be auto- 6389, Feb. 10, 1989] matically shut off when the sensor signals are broken. § 307.7 Safety requirements for electrical stimulating (EST) equipment. (3) Mandatory Warning Devices and Signals. The following warning devices (a) General. Electrical stimulating or signals shall be installed at each (EST) equipment is equipment that provides electric shock treatment to opening to the stimulating area carcasses for the purpose of accel- through which a person would nor- erating rigor mortis of facilitating mally enter: blood removal. These provisions do not (i) A red light that flashes distinctly apply to electrical equipment used to during the operating cycle of the stim- stun and/or slaughter animals or to fa- ulating equipment. cilitate hide removal. Electrical stimu- (ii) An ANSI Z53.1-Color Code sign lating equipment consists of two sepa- reading (a) ‘‘Danger Electrical Hazard’’ rate pieces—the control system and the for stimulating voltage below 50 or (b) applicator. The EST control system ‘‘Danger High Voltage’’ for stimulating contains the circuitry to generate voltage above 50. pulsed DC or AC voltage for stimula- (iii) An emergency stop button.

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(4) Optional Warning Device—Horn or 309.4 Livestock showing symptoms of cer- Bell. If a warning horn or bell is in- tain metabolic, toxic, nervous, or cir- stalled, the signal shall be audible culatory disturbances, nutritional imbal- above background noises in the vicin- ances, or infectious or parasitic diseases. ity, and it shall sound for at least 1 309.5 Swine; disposal because of hog cholera. second before each manual stimulation 309.6 Epithelioma of the eye. or before the carcass chain is started in 309.7 Livestock affected with anthrax; cleaning and disinfection of infected live- an automatic system. stock pens and driveways. (c) Operation—(1) Training. Only per- 309.8 Cattle affected with anasarca and gen- sons who have received safety instruc- eralized edema. tion by the equipment manufacturer or 309.9 Swine erysipelas. designee may operate electrical stimu- 309.10 Onset of parturition. lating equipment. 309.11 Vaccine livestock. (2) Cleaning and Maintenance. To pre- 309.12 Emergency slaughter; inspection vent an electrical shock to personnel, prior to. the electricity supplied to the stimu- 309.13 Disposition of condemned livestock. lating surfaces shall be locked-off when 309.14 Brucellosis-reactor goats. cleaning, mechanical inspection, main- 309.15 Vesicular diseases. tenance or testing are performed. 309.16 Livestock suspected of having bio- (3) Water. To prevent an electrical logical residues. shock, personnel shall not spray 309.17 Livestock used for research. streams of water on energized car- 309.18 Official marks and devices for pur- casses or on energized stimulating sur- poses of ante-mortem inspection. faces. AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.18, (d) Special provisions for manually op- 2.53. erated equipment.(1) Stimulating probes SOURCE: 35 FR 15563, Oct. 3, 1970, unless or clamps shall be stored in a sanitary otherwise noted. container which is insulated with a material approved by the Adminis- § 309.1 Ante-mortem inspection in pens trator. 1 of official establishments. (2) The electric wires attached to a (a) All livestock offered for slaughter clamp or probe shall not allow for con- in an official establishment shall be ex- tact between the probe or clamp and an amined and inspected on the day of and electrical ground and shall not extend before slaughter unless, because of un- outside the enclosure. usual circumstances, prior arrange- [53 FR 46432, Nov. 17, 1988, as amended at 64 ments acceptable to the Administrator FR 56415, Oct. 20, 1999] have been made in specific cases by the circuit supervisor for such examination PART 308 [RESERVED] and inspection to be made on a different day before slaughter. PART 309—ANTE-MORTEM (b) Such ante-mortem inspection INSPECTION shall be made in pens on the premises of the establishment at which the live- Sec. stock are offered for slaughter before 309.1 Ante-mortem inspection in pens of of- the livestock shall be allowed to enter ficial establishments. into any department of the establish- 309.2 Livestock suspected of being diseased ment where they are to be slaughtered or affected with certain conditions; iden- or dressed or in which edible products tifying suspects; disposition on post- are handled. When the holding pens of mortem inspection or otherwise. an official establishment are located in 309.3 Dead, dying, disabled, or diseased and similar livestock. a public stockyard and are reserved for the exclusive use of the establishment, such pens shall be regarded as part of 1 A list of approved insulation materials is the premises of that establishment and available upon request from the Facilities, Equipment and Sanitation Division, Tech- the operator of the establishment shall nical Services, Food Safety and Inspection be responsible for compliance with all Service, U.S. Department of Agriculture, requirements of the regulations in this Washington, DC 20250. subchapter with respect to such pens.

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§ 309.2 Livestock suspected of being U.S. Suspect and disposed of as pro- diseased or affected with certain vided in § 311.12 of this subchapter. conditions; identifying suspects; (f) Cattle found on ante-mortem in- disposition on post-mortem inspec- spection to be affected with anasarca tion or otherwise. to a lesser extent than as described in (a) Any livestock which, on ante- § 309.8 shall be identified as U.S. Sus- mortem inspection, do not clearly pects and disposed of as provided in show, but are suspected of being af- § 311.8 of this subchapter or paragraph fected with any disease or condition (g) of this section. that, under part 311 of this subchapter, (g) Any livestock suspected of being may cause condemnation of the carcass affected with anasarca may be set on post-mortem inspection, and any apart and held for treatment under livestock which show, on ante-mortem Program or other responsible official inspection, any disease or condition supervision approved by the area super- that, under part 311 of this subchapter visor. If at the expiration of the treat- would cause condemnation of only part ment period the livestock upon exam- of the carcass on post-mortem inspec- ination is found to be free from disease, tion, shall be so handled as to retain it may be released for any purpose. its identity as a suspect until it is Otherwise, it shall be identified as U.S. given final post-mortem inspection, Suspect and disposed of as provided in when the carcass shall be marked and § 311.8 of this subchapter or condemned disposed of as provided in parts 310 and and disposed of as provided in § 309.8, 311 of this subchapter, or until it is dis- whichever is appropriate. posed of as otherwise provided in this (h) All hogs suspected on ante- part. mortem inspection of being affected (b) All seriously crippled animals and with swine erysipelas shall be identi- non-ambulatory disabled livestock fied as U.S. Suspects and disposed of as shall be identified as U.S. Suspects and provided in § 311.5 of this subchapter or disposed of as provided in § 311.1 of this paragraph (i) of this section. subchapter unless they are required to (i) A hog suspected of being affected be classed as condemned under § 309.3. with swine erysipelas may be set apart Non-ambulatory disabled livestock are and held for treatment under Program livestock that cannot rise from a re- or other responsible official super- cumbent position or that cannot walk, vision approved by the area supervisor. including, but not limited to, those If at the expiration of the treatment with broken appendages, severed ten- period the animal upon examination is dons or ligaments, nerve paralysis, found to be free from disease, it may be fractured vertebral column, or meta- released for any purpose. Otherwise, it bolic conditions. shall be identified as U.S. Suspect and (c) Livestock which have reacted to a disposed of as provided in § 311.5 of this test for leptospirosis, or anaplasmosis, subchapter, or condemned and disposed but which show no symptoms of the of as provided in § 309.13, whichever is disease, shall be identified as U.S. Sus- appropriate. pects and disposed of as provided in (j) Any livestock which is affected § 311.10 of this subchapter. with vesicular exanthema or vesicular (d) Livestock which are known to stomatitis, but which has recovered to have reacted to the tuberculin test the extent that the lesions are in proc- shall be identified as U.S. Suspects and ess of healing, the temperature is with- disposed of as provided in § 311.2 of this in normal range, and the livestock subchapter, except that livestock bear- shows a return to normal appetite and ing an official ‘‘USDA Reactor’’ or activity, shall be identified as U.S. similar State reactor tag shall not be Suspect and disposed of as provided in tagged as U.S. Suspects. § 311.32 of this subchapter, except that (e) Any cattle found on ante-mortem if desired, such livestock may be set inspection to be affected with apart and held under supervision of a epithelioma of the eye or of the orbital Program employee or other official region to a lesser extent than as de- designated by the area supervisor for scribed in § 309.6 shall be identified as a treatment. If the livestock is set aside

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for treatment, the U.S. Suspect identi- accompanied with a form MP 402–2 on fication device will be removed by a which the inspector at the establish- Program employee, following such ment shall record the U.S. Suspect treatment, if the livestock is found to identification number and any other be free from any such disease. Such identifying tag numbers present and a livestock found to be free from any brief description of the animal and of such disease may be released for the disease or condition for which the slaughter or for purposes other than animal was classed as a suspect, in- slaughter, provided that in the latter cluding its temperature when the tem- instance, the operator of the official perature of such animal might have a establishment or the owner of the ani- bearing on the disposition of the car- mal shall first obtain permission from cass on post-mortem inspection. the local, State, or Federal livestock (p) When any animal identified as a sanitary official having jurisdiction U.S. Suspect is released for any pur- over the movement of such livestock. pose or reason, as provided in this part, (k) Livestock which are offered for the official identification device shall ante-mortem inspection under this be removed only by a Program em- part, and which are regarded by the in- ployee and he shall report his action to spector as immature, shall be identi- the area supervisor. When a suspect is fied as U.S. Suspects and, if slaugh- to be released under the provisions of tered, the disposition of their carcasses this part for a purpose other than shall be determined by the post- slaughter, the operator of the official mortem findings in connection with establishment or the owner of the ani- the ante-mortem conditions. If not mal shall first obtain permission for slaughtered as suspects, such livestock the removal of such animal from the shall be held under supervision of a local, State or Federal livestock sani- Program employee or other official tary official having jurisdiction. designated by the area supervisor, and [35 FR 15563, Oct. 3, 1970, as amended at 38 FR after sufficient development may be re- 29214, Oct. 23, 1973; 39 FR 36000, Oct. 17, 1974; leased for slaughter or may be released 69 FR 1873, Jan. 12, 2004] for any other purpose, provided they have not been exposed to any infec- § 309.3 Dead, dying, disabled, or dis- tious or contagious disease. If such ex- eased and similar livestock. posure occurs, permission should be ob- (a) Livestock found to be dead or in a tained from the nearest Veterinary dying condition on the premises of an Services unit of the Animal and Plant official establishment shall be identi- Health Inspection Service prior to re- fied as U.S. Condemned and disposed of lease of such livestock. in accordance with § 309.13. (l) Livestock previously condemned (b) Livestock plainly showing on for listeriosis, if released for slaughter ante-mortem inspection any disease or under § 309.13(b) shall be identified as a condition that, under part 311 of this U.S. Suspect in accordance with subchapter, would cause condemnation § 309.13(c). of their carcasses on post-mortem in- (m) Each animal required by this spection shall be identified as U.S. Con- part to be treated as a U.S. Suspect demned and disposed of in accordance shall be identified as such by or under with § 309.13. the supervision of a Program employee (c) Any swine having a temperature with an official device in accordance of 106 °F. or higher and any cattle, with § 309.18. No such device shall be re- sheep, goats, horses, mules, or other moved except by a Program employee. equines having a temperature of 105 °F. (n) Each animal identified as a U.S. or higher shall be identified as U.S. Suspect on ante-mortem inspection Condemned. In case of doubt as to the shall be set apart and shall be slaugh- cause of the high temperature, or when tered separately from other livestock for other reasons a Program employee at that establishment unless disposed deems such action warranted, any such of as otherwise provided in this part. livestock may be held for a reasonable (o) Each animal identified as a U.S. time under the supervision of a Pro- Suspect on ante-mortem inspection, gram employee for further observation when presented for slaughter shall be and taking of temperature before final

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disposition of such livestock is deter- (b) If any equine is suspected on ante- mined. Any livestock so held shall be mortem inspection of being infected reinspected on the day it is slaugh- with glanders or dourine, the nearest tered. If, upon such reinspection, or Veterinary Services unit of the Animal when not held for further observation and Plant Health Inspection Service and taking of temperature, then on the shall be so informed by a Program em- original inspection, the animal has a ployee. Tests shall be performed by temperature of 106 °F. or higher in the said unit to determine whether the ani- case of swine, or 105 °F. or higher in the mal is, in fact, infected with such dis- case of other livestock, it shall be con- ease. If it is found on such tests to be demned and disposed of in accordance infected, the animal shall be disposed with § 309.13. of in accordance with paragraph (a) of (d) Any livestock found in a coma- this section. Otherwise, the animal tose or semicomatose condition or af- shall be identified as a U.S. Suspect fected with any condition not other- and disposed of as provided in § 311.10 of wise covered in this part, which would this subchapter. preclude release of the animal for [35 FR 15563, Oct. 3, 1970 as amended at 38 FR slaughter for human food, shall be 29214, Oct. 23, 1973] identified ‘‘U.S. Condemned’’ and disposed of in accordance with § 309.13, ex- § 309.5 Swine; disposal because of hog cept that such animal may be set apart cholera. and held for further observation or (a) All swine found by an inspector to treatment under supervision of a Pro- be affected with hog cholera shall be gram employee or other official des- identified as U.S. Condemned and dis- ignated by the area supervisor and for posed of in accordance with § 309.13. Im- final disposition in accordance with mediate notification shall be given by this part. the inspector to the official in the Vet- (e) Establishment personnel must no- erinary Services unit of the Animal tify FSIS inspection personnel when and Plant Health Inspection Service cattle become non-ambulatory disabled who has responsibility for the control after passing ante-mortem inspection. of swine diseases in the State where Non-ambulatory disabled cattle that the swine are located. are offered for slaughter must be con- (b) All swine, even though not them- demned and disposed of in accordance selves identified as U.S. Suspects, with § 309.13. which are of lots in which one or more [35 FR 15563, Oct. 3, 1970, as amended at 69 FR animals have been condemned or iden- 1873, Jan. 12, 2004; 72 FR 38729, July 13, 2007; tified as U.S. Suspect for hog cholera, 74 FR 11466, Mar. 18, 2009] shall, as far as possible, be slaughtered separately and apart from all other § 309.4 Livestock showing symptoms of livestock passed on ante-mortem in- certain metabolic, toxic, nervous, or spection. circulatory disturbances, nutritional imbalances, or infectious or [40 FR 27225, June 27, 1975] parasitic diseases. (a) All livestock showing, on ante- § 309.6 Epithelioma of the eye. mortem inspection, symptoms of Any animal found on ante-mortem anaplasmosis, ketosis, leptospirosis, inspection to be affected with listeriosis, parturient paresis, epithelioma of the eye and the orbital pseudorabies, rabies, scrapie, tetanus, region in which the eye has been de- grass tetany, transport tetany, stran- stroyed or obscured by neoplastic tis- gles, purpura hemorrhagica, azoturia, sue and which shows extensive infec- infectious equine encephalomyelitis, tion, suppuration, and necrosis, usually toxic encephalomyelitis (forage poi- accompanied with foul odor, or any soning), dourine, acute influenza, gen- animal affected with epithelioma of eralized osteoporosis, glanders (farcy), the eye or of the orbital region which, acute inflammatory lameness or exten- regardless of extent, is accompanied sive fistula shall be identified as U.S. with cachexia shall be identified as Condemned and disposed of in accord- U.S. Condemned and disposed of in ac- ance with § 309.13. cordance with § 309.13.

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§ 309.7 Livestock affected with an- a thorough disinfection of the exposed thrax; cleaning and disinfection of premises by soaking the ground, infected livestock pens and drive- fences, gates, and all exposed material ways. with a 5 percent solution of sodium hy- (a) Any livestock found on ante- droxide or commercial lye prepared as mortem inspection to be affected with outlined in § 310.9(e)(1) of this sub- anthrax shall be identified as U.S. Con- chapter, or other disinfectant that may demned and disposed of in accordance be approved in specific cases by the Ad- with § 309.13. ministrator specifically for this pur- (b) No other livestock of a lot in pose. which anthrax is found on ante- mortem inspection shall be slaughtered § 309.8 Cattle affected with anasarca and presented for post-mortem inspec- and generalized edema. tion until it has been determined by a All cattle found on ante-mortem in- careful ante-mortem inspection that no spection to be affected with anasarca anthrax infected livestock remains in in advanced stages and characterized the lot. by an extensive and generalized edema (c) Apparently healthy livestock shall be identified as U.S. Condemned (other than hogs) from a lot in which and disposed of in accordance with anthrax is detected, and any appar- § 309.13. ently healthy livestock which have been treated with anthrax biologicals § 309.9 Swine erysipelas. which do not contain living anthrax organisms, may be slaughtered and pre- All hogs plainly showing on ante- sented for post-mortem inspection if mortem inspection that they are af- they have been held not less than 21 fected with acute swine erysipelas shall days following the last treatment or be identified as U.S. Condemned and the last death of any livestock in the disposed of in accordance with § 309.13. lot. Alternatively, if desired, all apparently healthy livestock of the lot may § 309.10 Onset of parturition. be segregated and held for treatment Any livestock showing signs of the by a State licensed veterinarian under onset of parturition shall be withheld supervision of a Program employee or from slaughter until after parturition other official designated by the area and passage of the placenta. Slaughter supervisor. No anthrax vaccine (live or- or other disposition may then be per- ganisms) shall be used on the premises mitted if the animal is otherwise ac- of an official establishment. ceptable. (d) Livestock which have been injected with anthrax vaccines (live or- § 309.11 Vaccine livestock. ganisms) within 6 weeks, and those bearing evidence of reaction to such Vaccine livestock with unhealed le- treatment, such as inflammation, tu- sions of vaccinia, accompanied with mefaction, or edema at the site of the fever, which have not been exposed to injection, shall be condemned on ante- any other infectious or contagious dis- mortem inspection, or such animals ease, are not required to be slaughtered may be held under supervision of a Pro- and may be released for removal from gram employee or other official des- the premises. ignated by the area supervisor until the expiration of the 6-week period and § 309.12 Emergency slaughter; inspection prior to. the disappearance of any evidence of reaction to the treatment. In all cases of emergency slaughter, (e) When livestock are found on ante- except as provided in § 311.27 of this mortem inspection to be affected with subchapter, the animals shall be in- anthrax, all exposed livestock pens and spected immediately before slaughter, driveways of the official establishment whether theretofore inspected or not. shall be cleaned and disinfected by When the necessity for emergency promptly and thoroughly removing and slaughter exists, the establishment burning all straw, litter, and manure. shall notify the inspector in charge so This shall be followed immediately by that such inspection may be made.

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§ 309.13 Disposition of condemned live- Federal livestock sanitary official hav- stock. ing jurisdiction. (a) Except as otherwise provided in [35 FR 15563, Oct. 3, 1970, as amended at 72 FR this part, livestock identified as U.S. 38729, July 13, 2007] Condemned shall be killed by the official establishment, if not already dead. § 309.14 Brucellosis-reactor goats. Such animals shall not be taken into Goats which have reacted to a test the official establishment to be slaugh- for brucellosis shall not be slaughtered tered or dressed; nor shall they be con- in an official establishment. veyed into any department of the establishment used for edible products; § 309.15 Vesicular diseases. but they shall be disposed of in the (a) Immediate notification shall be manner provided for condemned car- given by the inspector to the local, casses in part 314 of this subchapter. State, and Federal livestock sanitary The official U.S. Condemned tag shall officials having jurisdiction when any not be removed from, but shall remain livestock is found to be affected with a on the carcass until it goes into the vesicular disease. tank, or is otherwise disposed of as pre- (b) No livestock under quarantine by scribed in part 314 of this subchapter, State or Federal livestock sanitary of- at which time such tag may be re- ficials on account of a vesicular disease moved by a Program employee only. will be given ante-mortem inspection. The number of such tag shall be re- If no quarantine is invoked, or if quar- ported to the veterinary medical offi- antine is invoked and later removed, cer by the inspector who affixed it, and upon ante-mortem inspection, any ani- also by the inspector who supervised mal found to be affected with vesicular exanthema or vesicular stomatitis in the tanking of the carcass. the acute stages, as evidenced by acute (b) Any livestock condemned on ac- and active lesions or an elevated tem- count of ketosis, swine erysipelas, ve- perature, shall be identified as U.S. sicular diseases, grass tetany, trans- Condemned and disposed of in accord- port tetany, parturient paresis, ance with § 309.13. anasarca, anaplasmosis, leptospirosis, listeriosis, or inflammatory condition § 309.16 Livestock suspected of having including pneumonia, enteritis, and biological residues. peritonitis may be set apart and held (a) Except as provided by paragraph for treatment under supervision of a (d) of this section, livestock suspected Program employee or official des- of having been treated with or exposed ignated by the area supervisor. Veal to any substance that may impart a bi- calves that are unable to rise from a ological residue which would make the recumbent position and walk because edible tissues unfit for human food or they are tired or cold may also be set otherwise adulterated shall be handled apart and held as provided in this para- in compliance with the provisions of graph. The U.S. Condemned identifica- this paragraph. They shall be identified tion tag will be removed by a Program at official establishments as ‘‘U.S. Con- employee following treatment under demned.’’ These livestock may be held such supervision if the animal is found under the custody of a Program em- to be free from any such disease. ployee, or other official designated by (c) Livestock previously affected the Administrator, until metabolic with listeriosis, including those re- processes have reduced the residue suf- leased for slaughter after treatment ficiently to make the tissues fit for under paragraph (b) of this section, human food and otherwise not adulter- shall be identified as U.S. Suspect. ated. When the required time has (d) When livestock under the provi- elapsed, the livestock, if returned for sions of this section is to be released slaughter, must be re-examined on for a purpose other than slaughter, the ante-mortem inspection. To aid in de- operator of the official establishment termining the amount of residue or the owner of the livestock shall first present in the tissues, officials of the obtain permission for the movement of Program may permit the slaughter of such livestock from the local, State, or any such livestock for the purpose of

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collecting tissues for analysis for the tify each calf as one of the following: residue. Such analysis may include the (a) Certified, (B) noncertified, or (C) use of inplant screening procedures de- previous residue condemnation. signed to detect the presence of anti- (3) Certified group. (i) For a calf to be microbial residues in any species of considered certified, the producer and livestock. all other subsequent custodians of the (b) All carcasses and edible organs calf must certify in writing that while and other parts thereof, in which are the calf was in his or her custody, the found any biological residues which calf was not treated with animal drugs render such articles adulterated, shall or was treated with one or more drugs be marked as ‘‘U.S. Condemned’’ and in accordance with FDA approved label disposed of in accordance with § 314.1 or directions and was withheld from § 314.3 of this chapter. slaughter for the period(s) of time spec- (c) [Reserved] ified by those label directions. All prior (d) Calves shall not be presented for certifications must be presented with ante-mortem inspection in an official the animal at the time of slaughter. establishment except under the provi- The certifications shall contain a list sions of this paragraph. of the calves with accompanying iden- (1) Definitions. For purposes of this tification numbers, as required by paragraph, the following definitions paragraph (d)(3)(ii) of this section, fol- shall apply: lowed by the following language: (i) Calf. A calf up to 3 weeks of age or I hereby certify that, while in my custody, up to 150 pounds. from llll to llll (time period of cus- (ii) Certified calf. A calf that the pro- tody), the above-listed calf or calves have ducer and all other subsequent not been treated with drugs, or have been custodians of the calf certify in writing treated with one or more drugs in accord- has not been treated with any animal ance with FDA approved label directions and drug while in his or her custody or has have been withheld from slaughter for the been treated with one or more drugs in period(s) of time specified by those label di- accordance with FDA approved label rections. I certify that, to the best of my knowledge and belief, all information con- directions while in his or her custody tained herein is true, that the information and has been withheld from slaughter may be relied upon at the official establish- for the period(s) of time specified by ment, and that I understand that any willful those label directions. falsification of this certification is a felony (iii) Healthy calf. A calf that an in- and may result in a fine of up to $250,000 for spector determines shows no visual an individual or up to $500,000 for an organi- signs of disease or treatment of disease zation, or imprisonment for not more than 5 at ante-mortem inspection. years, or both (21 U.S.C. 677, 18 U.S.C. 1001 and 3571). (iv) Producer. The owner of the calf at the time of its birth. Executed on lllllllllllllllll (v) Sick calf. A calf that an inspector (date of certification) on ante-mortem inspection determines llllllllllllllllllllllll has either signs of treatment or signs (signature of certifier) of disease. llllllllllllllllllllllll (vi) Veterinary medical officer. An in- (typed or printed name and address of cer- spector of the Program that has ob- tifier) tained a Doctor of Veterinary Medicine llllllllllllllllllllllll degree which is recognized by the Pro- (business of certifier) gram. (ii) Each calf must be identified by (2) General requirements. (i) The iden- use of backtag, eartag, or other type of tity of the producer of each calf pre- secure identification which displays a sented for ante-mortem inspection number which shall be recorded on all shall be made available by the official written certifications. establishment to the inspection prior (iii) The inspector shall have seg- to the animal being presented for ante- regated for veterinary medical officer mortem inspection. examination any certified calf which (ii) The inspector shall segregate the he or she determines to show any sign calves presented for ante-mortem in- of disease or which is not identified inspection at the establishment and iden- dividually. Such animal will be tagged

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as ‘‘U.S. Suspect’’ and its carcass will § 309.17 Livestock used for research. be retained on post-mortem inspection (a) No livestock used in any research and handled in accordance with § 310.21 investigation involving an experi- (c) and (d). mental biological product, drug, or (iv) The inspector shall handle the re- chemical shall be eligible for slaughter maining carcasses of healthy animals at an official establishment unless: in accordance with § 310.21(c) and (d). (1) The operator of such establish- (4) Noncertified group. On ante- ment, the sponsor of the investigation, mortem inspection, the inspector shall or the investigator has submitted to have segregated for veterinary medical the Program, or the Veterinary Serv- officer examination any calf which he ices unit of the Animal and Plant or she determines to show any sign of Health Inspection Service of the De- disease. Such animal will be tagged as partment of Agriculture or to the Envi- ‘‘U.S. Suspect’’ and its carcass will be ronmental Protection Agency or to the retained on post-mortem inspection Food and Drug Administration of the and handled in accordance with Department of Health, Education, and § 310.21(c). The inspector shall handle Welfare, data or a summary evaluation the remaining carcasses of healthy ani- of the data which demonstrates that mals in accordance with § 310.21(c). the use of such biological product, (5) Calves from producers with previous drug, or chemical will not result in the residue condemnation. On ante-mortem products of such livestock being adul- inspection, the inspector shall have terated, and a Program employee has approved such slaughter; segregated for veterinary medical officer examination any calf which he or (2) Written approval by the Deputy Administrator, Meat and Poultry In- she determines to show any sign of dis- spection Field Operations is furnished ease. Such animal will be tagged as the area supervisor prior to the time of ‘‘U.S. Suspect’’ and its carcass will be slaughter; retained on post-mortem inspection (3) In the case of an animal adminis- and handled in accordance with tered any unlicensed, experimental § 310.21(e). The inspector shall handle veterinary biologic product regulated the remaining carcasses of healthy ani- under the Virus-Serum Toxin Act (21 mals in accordance with § 310.21(e). U.S.C. 151 et seq.), the product was pre- (e) The name of each and all person(s) pared and distributed in compliance who sold or consigned each swine to with Part 103 of the regulations issued the establishment shall be made avail- under said Act (part 103 of this title), able by the establishment to any Pro- and used in accordance with the label- gram employee or other authorized em- ing approved under said regulations; ployee of the United States Depart- (4) In the case of an animal adminis- ment of Agriculture upon that employ- tered any investigational drug regu- ee’s request and presentation of his or lated under the Federal Food, Drug, her official credentials. Swine identi- and Cosmetic Act, as amended (21 fication, by means approved by the U.S.C. 301 et seq.), the drug was pre- Animal and Plant Health Inspection pared and distributed in compliance Service, USDA, under part 71 of this with the applicable provisions of part title, must be maintained throughout 135 of the regulations issued under said post-mortem inspection, in accordance Act (21 CFR part 135), and used in ac- with § 310.23(a) of this subchapter. cordance with the labeling approved under said regulations; (Recordkeeping requirements approved by (5) In the case of an animal subjected the Office of Management and Budget under to any experimental economic poison control number 0583–0053) under section 2(a) of the Federal Insec- [36 FR 24928, Dec. 24, 1971, as amended at 44 ticide, Fungicide, and Rodenticide Act, FR 45606, Aug. 3, 1979; 44 FR 59499, Oct. 16, as amended (7 U.S.C. 135 et seq.), the 1979; 47 FR 746, Jan. 7, 1982; 47 FR 41336, Sept. product was prepared and distributed 20, 1982; 50 FR 32164, Aug. 9, 1985; 50 FR 53127, in accordance with § 362.17 of the regu- Dec. 30, 1985; 52 FR 2104, Jan. 20, 1987; 53 FR lations issued under said Act (7 CFR 40387, Oct. 14, 1988; 55 FR 7474, Mar. 2, 1990] 362.17), and used in accordance with the

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labeling approved under said regula- PART 310—POST-MORTEM tions. INSPECTION (6) In the case of an animal administered or subjected to any substance Sec. that is a food additive or pesticide 310.1 Extent and time of post-mortem in- chemical under the Federal Food, spection; post-mortem inspection staff- Drug, and Cosmetic Act, supra, there ing standards. has been compliance with all tolerance 310.2 Identification of carcass with certain limitations established by said Act and severed parts thereof and with animal from which derived. the regulations promulgated there- 310.3 Carcasses and parts in certain in- under (21 CFR 1.1 et seq.), and all other stances to be retained. restrictions and requirements imposed 310.4 Identification of carcasses and parts; by said Act and said regulations will be tagging. complied with at the time of slaughter. 310.5 Condemned carcasses and parts to be (b) The inspector in charge may deny so marked; tanking; separation. 310.6 Carcasses and parts passed for cook- or withdraw the approval for slaughter ing; marking. of any livestock subject to the provi- 310.7 Removal of spermatic cords, pizzles sion of this section when he deems it and preputial diverticuli. necessary to assure that all products 310.8 Passing and marking of carcasses and prepared at the official establishment parts. are free from adulteration. 310.9 Anthrax; carcasses not to be eviscerated; disposition of affected carcasses; § 309.18 Official marks and devices for hides, hoofs, horns, hair, viscera and contents, and fat; handling of blood and purposes of ante-mortem inspec- scalding vat water; general cleanup and tion. disinfection. (a) All livestock required by this part 310.10 Carcasses with skin or hide on; clean- to be identified as U.S. Suspects shall ing before evisceration; removal of lar- be tagged with a serially numbered vae of Hypodermae, external parasites and other pathological skin conditions. metal ear tag bearing the term ‘‘U.S. 310.11 Cleaning of hog carcasses before in- Suspect,’’ except as provided in cising. § 309.2(d) and except that cattle affected 310.12 Sternum to be split; abdominal and with epithelioma of the eye, thoracic viscera to be removed. antinomycosis, or actinobacillosis to 310.13 Inflating carcasses or parts thereof; such an extent that the lesions would transferring caul or other fat. be readily detected on post-mortem in- 310.14 Handling of bruised parts. 310.15 Disposition of thyroid glands and la- spection, need not be individually ryngeal muscle tissue. tagged on ante-mortem inspection with 310.16 Disposition of lungs. the U.S. Suspect tag, provided that 310.17 Inspection of mammary glands. such cattle are segregated and other- 310.18 Contamination of carcasses, organs, wise handled as U.S. Suspects. or other parts. (b) In addition, identification of U.S. 310.19 Inspection of kidneys. 310.20 Saving of blood from livestock as an Suspect swine must include the use of edible product. tattoos specified by the inspector to 310.21 Carcasses suspected of containing maintain the identity of the animals sulfa and antibiotic residues; sampling through the dehairing equipment when frequency; disposition of affected car- such equipment is used. casses and parts. (c) All livestock required by this part 310.22 Specified risk materials from cattle and their handling and disposition. to be identified as U.S. Condemned 310.23 Identification of carcasses and parts shall be tagged with a serially num- of swine. bered metal ear tag bearing the term 310.24 [Reserved] ‘‘U.S. Condemned.’’ 310.25 Contamination with microorganisms; (d) The devices described in para- process control verification criteria and graphs (a), (b), and (c) of this section testing; pathogen reduction standards. shall be the official devices for identi- AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.18, fication of livestock required to be 2.53. identified as U.S. Suspect or U.S. Con- SOURCE: 35 FR 15567, Oct. 3, 1970, unless demned as provided in this part. otherwise noted.

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§ 310.1 Extent and time of post-mortem (i) Inspection Using the Viscera inspection; post-mortem inspection Truck. staffing standards. (a) A careful post-mortem examina- STEERS AND HEIFERS tion and inspection shall be made of Number of inspectors the carcasses and parts thereof of all Maximum slaughter rates (head per by stations livestock slaughtered at official estab- hour) Car- lishments. Such inspection and exam- Head Viscera cass

ination shall be made at the time of 1 to 27 ...... a a a slaughter unless, because of unusual 28 to 56 ...... b b b circumstances, prior arrangements ac- 57 to 84 ...... 1 1 1 ceptable to the Administrator have 85 to 86 ...... 1 2 1 been made in specific cases by the cir- 87 to 143 ...... 2 2 1 cuit supervisor for making such inspection and examination at a later time. COWS AND BULLS (b)(1) The staffing standards on the Number of inspectors basis of the number of carcasses to be Maximum slaughter rates (head per by stations inspected per hour are outlined in the hour) Car- following tables. Standards for mul- Head Viscera cass tiple inspector lines are based on inspectors rotating through the different 1 to 27 ...... a a a 28 to 55 ...... b b b types of inspection stations during 56 to 77 ...... 1 1 1 each shift to equalize the workload. 78 to 81 ...... 1 2 1 The inspector in charge shall have the 82 to 134 ...... 2 2 1 authority to require the establishment to reduce slaughter line speeds where, (A) Rules for determining adjusted in his judgment, the inspection proce- maximum slaughter rates for single-in- dure cannot be adequately performed spector kills considering walking dis- at the current line speed because of tance according to the table in this particular deficiencies in carcass prep- subdivision: Determine the distances aration and presentation by the plant the inspector actually walks between at the higher speed, or because the the points shown in columns 2 through health condition of the particular ani- 14 of the following table. For each col- mals indicates a need for more exten- umn, determine the deduction figure sive inspection. opposite the appropriate number of feet (2) Cattle inspection. For all cattle in column 1. Compute the total of the staffing standards, an ‘‘a’’ in the deduction figures for columns 2 ‘‘Number of Inspectors by Stations’’ through 14. The adjusted maximum column means that one inspector per- rate is the maximum rate in paragraph forms the entire inspection procedure (b)(2)(i) of this section minus total of and a ‘‘b’’ means that one inspector the deduction figures. If the resultant performs the head and lower carcass in- number is not a whole number, it must spection and a second inspector per- be rounded off to the next lowest whole forms the viscera and upper carcass in- number. spection. 1 included. To determine the proper adjusted 1 The ‘‘Maximum Slaughter Rates’’ figures maximum slaughter line speed, paragraph listed in paragraph (b)(2)(i) of this section for (b)(2)(i)(A) of this section for one inspector one (a) and two (b) inspector kills are over- kills or paragraph (b)(2)(i)(B) of this section stated because the time required to walk for two inspector kills must be used along from one inspection station to another is not with their accompanying rules.

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1 Bulls Cows 13 basin Head rack and wash- Strs. Hfrs.

1 Bulls Cows 12 Washbasin Strs. Hfrs. and high rail Bulls Cows 11 Head rack washbasin and closest Strs. Hfrs. Bulls Cows 10

high rail Low rail and Strs. Hfrs. RUCK T Bulls Cows 9 high rail Viscera and Strs. Hfrs. ISCERA —V Bulls Cows ILL 8 K washbasin Viscera and Strs. Hfrs. ATTLE C Bulls Cows 7 and low rail Strs. Hfrs. Tags—brands and Bulls NSPECTOR 2 Cows -I 6 NE washbasin Strs. Hfrs. Carcass O

2 Bulls Cows 5 Head rack and carcass Strs. Hfrs. Bulls Cows 4 [Table of deductions from maximum slaughter rates for each 2 feet between points (in tenths cattle per hour)] head rack Low rail and Strs. Hfrs. Bulls Cows 3 low rail Viscera and Strs. Hfrs. Bulls Cows 2 Head rack and high rail Strs. Hfrs. 1 0 0 0 0 3 0 0 0 0 0 0.1 0 0.1 0 0 0 5 0 0.1 0 0 0.1 0 0 0 0.2 0 0 0 0 0 0 0 0.1 0 7 0 0 0 0 0 0 0.1 0 0 0.1 0 0 0 9 0 0.1 0 0.1 0 0 0 0.1 0 0.2 0 0 0.2 0.1 0 0 0.1 0.2 0 0.1 0.1 0 0.4 0 0 0.3 0 0 0.1 0 0.1 0.3 0.1 0.1 0 0 0 0 0.3 0 11 0.1 0.1 0.2 0.2 0.2 0.2 0 0.1 0.2 11 0.5 0.6 0.2 0 0.4 0 0.1 0.3 0.2 0 0 0.2 0.4 0.1 0.1 0.1 0.2 0.2 0 13 0.6 0.7 0.3 0 0 0.5 0 0.1 0.4 0.3 0 0 0.2 0.5 0.1 0.1 0.2 0.3 0 15 0.7 0.9 0.3 0 0 0.6 0 0.2 0.9 1.0 0.4 0.3 0 0 0.3 0.5 0.2 0.2 0.2 0.1 0.2 0.3 0.3 0 0.2 0.2 17 0.4 0 0 0.7 0 0.1 1.0 1.1 0.5 0.4 0 0 0.3 0.6 0.2 0.2 0.1 0.3 0.4 0.2 0.2 19 0.4 0 0 0.8 0 0.1 1.1 1.3 0.5 0.4 0 0 0.4 0.7 0.3 0.2 0.2 0.3 0.4 0.4 0.3 0.2 21 0.5 0 0 0.9 0.8 0 0.1 1.2 1.4 0.6 0.5 0 0 0.4 0.8 0.3 0.3 0.2 0.3 0.4 0.5 0.3 0.3 23 0.5 0 0 1.0 0.9 0 0.1 1.3 1.5 0.7 0.5 0 0 0.5 0.9 0.3 0.3 0.2 0.4 0.5 0.5 0.3 0.3 25 0.6 0.5 0 0 1.1 1.0 0 0.1 1.4 1.7 0.7 0.5 0 0 0.5 1.0 0.3 0.3 0.2 0.4 0.5 0.6 0.3 0.3 27 0.6 0 0 1.2 1.1 0 0.1 1.5 1.8 0.8 0.6 0 0 0.6 1.1 0.4 0.3 0.2 0.4 0.5 0.6 0.4 0.3 29 0.7 0.6 0 0 1.3 1.2 0 0.1 1.6 1.9 0.8 0.6 0 0 0.6 1.2 0.4 0.4 0.3 0.2 0.5 0.6 0.7 0.4 0.4 31 0.7 0 0 1.3 1.4 0 0.1 1.7 2.1 0.9 0.7 0 0 0.7 1.3 0.4 0.4 0.3 0.5 0.6 0.7 0.4 0.4 33 0.8 0.7 0 0 1.4 0 0.1 1.8 2.2 1.0 0.7 0 0 0.7 1.3 0.5 0.4 0.3 0.6 0.7 0.8 0.5 0.4 35 0.8 0 0 1.9 2.3 1.5 0 0.2 1.0 0.8 0.5 0 0 0.8 1.4 .0.8 0.8 0.3 0.5 0.6 0.7 37 0 0.2 2.1 2.6 0.9 0.8 0 0 1.6 0.6 0.5 2.0 2.4 1.1 0.8 2.2 2.7 0 0 0.8 1.5 0.9 0.6 0.5 0.5 0.5 0.3 0.6 0.5 0.6 0.8 1.7 1.8 0.9 0 0.2 0.5 0.5 0.6 0.5 39 0.9 0 0 0.9 1.7 1.7 0 0.2 0.1 0.2 1.1 0.9 2.3 2.8 0 0 0.1 0.7 0.9 0.9 1.6 1.0 0.4 0.3 0.6 0 0.1 0.7 0.8 1.8 1.9 0.6 41 1.0 0.9 0 1.0 1.8 0.1 0.2 1.2 0.9 2.4 2.9 0 0.1 0.7 0.9 1.0 0.4 0.6 0 0.1 1.9 2.0 0.6 43 1.0 0.9 1.0 1.8 0.1 0.2 1.2 0.9 2.5 3.1 0 0.1 0.8 0.9 1.1 0.4 0.7 0.6 0 0.1 2.0 2.1 0.7 0.6 45 1.1 1.0 1.1 1.9 0.1 0.2 1.3 1.0 2.6 3.2 0 0.1 0.8 1.0 1.1 0.4 0.7 0 0.1 2.1 2.2 0.7 47 1.1 1.0 1.1 2.0 0.1 0.3 1.4 1.0 2.7 3.3 0 0.1 0.8 1.0 1.2 0.4 0.7 0 0.1 2.2 0.7 49 1.2 1.1 1.2 2.1 0.1 0.3 1.4 1.1 2.8 3.4 0 0.1 0.9 1.1 1.2 0.5 0.8 0.7 0 0.1 2.3 0.8 0.7 51 1.2 1.1 1.2 2.2 0.1 0.3 1.5 1.1 2.9 3.5 0 0.1 0.9 1.1 1.3 0.5 0.8 0.7 0 0.1 2.3 2.4 0.8 0.7 53 1.2 1.2 2.3 0.1 0.3 1.5 1.2 3.0 3.6 0 0.1 1.0 1.2 1.3 0.5 0.8 0 0.1 2.4 2.5 0.8 55 1.3 1.2 1.3 2.3 0.1 0.3 1.6 1.2 0 0.1 1.0 1.2 1.4 0.5 0 0.1 2.5 2.6 57 1.3 1.3 2.4 1.6 1.3 0 0.1 1.0 1.3 0.5 0 0.1 59 The washbasin referred to here is the one inspector uses while enroute from head rack high rail inspection. This refers to the carcass in bleeding area. 1 1 2 be- feet Num- ber of tween points

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(B) Rules for determining adjusted termine the deduction figure opposite maximum slaughter rates for two-in- the appropriate number of feet in col- spector kills considering walking dis- umn 1. Compute the total of the deduc- tance according to the table in this tion figures for columns 2 through 9. subdivision: Determine the distances Divide this total by 2. The adjusted the inspectors actually walk between maximum rate is the maximum rate in the points shown in columns 2 through paragraph (b)(2)(i) of this section 9 of the following table. Column 9 is minus the number calculated above. If used only if the condemned brands and the resultant number is not a whole tags the viscera inspector uses are kept number, it must be rounded off to the at a location other than at the wash- next lowest whole number. basin-sterilizer. For each column, de-

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1 basin Strs. Hfrs. Viscera and wash- Bulls Cows basin Strs. Hfrs. High rail and wash- Bulls Cows rail Strs. Hfrs. Viscera and high

RUCK T Bulls Cows ISCERA Strs. Hfrs. tags (washbasin) Viscera and brands —V ILL K Bulls Cows ATTLE rail C Strs. Hfrs. Head rack and low NSPECTOR -I Bulls Cows WO rail T Strs. Hfrs. Washbasin and low

Bulls 2 Cows casses [Table of deductions from maximum slaughter rates for each 2 feet between points (in tenths cattle per hour)] Strs. Hfrs. Heads and low rail inspection Viscera and high rail inspection Head rack and car- Bulls Cows 2 3 4 5 6 7 8 9 2 3 4 5 6 7 8 washbasin Head rack and Strs. Hfrs. 3 0.1 0 0.1 0 0.1 0 0 0 0 0 0 0 0 0 0.1 0.2 0.1 0.1 0 0.1 0 1 0 0.1 0 3 5 0.1 0.8 0.7 0.4 0.5 0.2 0.3 7 0.1 0.2 1.5 1.4 0.7 0.9 1.0 0.3 0.4 9 0.2 0.1 2.2 2.0 1.1 1.3 1.5 0.4 0.5 11 0.2 0.3 0.1 2.8 2.7 1.4 1.7 1.9 1.8 0.5 0.6 0.4 13 0.2 0.4 0.1 0.3 3.5 3.3 1.7 2.1 2.4 2.2 0.6 0.7 0.5 0.8 15 0.3 0.4 0.1 0.2 4.1 3.9 2.0 2.5 2.9 2.6 0.7 0.9 0.6 17 0.3 0.5 0.1 0.4 0.2 4.8 4.5 2.4 2.9 3.3 3.0 0.8 1.0 0.7 19 0.3 0.6 0.2 0.4 5.4 5.1 2.7 3.3 3.7 3.4 0.9 1.2 0.7 21 0.3 0.6 0.2 0.4 6.0 5.7 3.0 3.7 4.2 1.0 1.3 0.8 23 0.4 0.7 0.2 0.5 0.3 6.6 6.3 3.3 4.0 4.6 4.1 1.2 1.4 0.9 25 0.4 0.7 0.2 0.5 0.3 7.2 6.8 3.6 4.4 5.0 4.5 1.3 1.6 1.0 27 0.4 0.8 0.2 0.6 0.5 7.8 7.4 3.9 4.7 5.4 4.9 1.4 1.7 1.0 29 0.5 0.9 0.2 0.6 0.4 8.3 7.9 4.2 5.1 5.8 5.2 1.5 1.8 1.1 31 0.5 0.9 0.2 0.7 0.4 0.6 8.9 8.5 4.5 5.4 6.2 5.6 1.6 2.0 1.2 33 0.5 1.0 0.2 0.7 0.4 9.4 9.0 4.8 5.8 6.5 5.9 1.7 2.1 1.3 10.0 9.5 5.0 6.1 6.9 6.3 1.8 2.2 1.3 2.3 35 0.6 1.1 0.3 0.8 0.5 0.7 10.0 5.3 6.4 7.3 6.6 1.9 2.4 1.4 10.5 37 0.6 1.1 0.3 0.8 0.5 0.7 10.5 5.6 6.8 7.6 6.9 2.0 2.5 1.5 11.0 39 0.6 1.2 0.3 0.9 0.5 0.8 11.0 5.9 7.1 8.0 7.2 2.1 2.6 1.5 11.5 41 0.7 1.2 0.3 0.9 0.6 0.8 11.4 6.1 7.4 8.3 7.6 2.2 2.8 1.6 12.0 43 0.7 1.3 0.3 0.9 0.6 11.9 6.4 7.7 8.7 7.9 2.4 2.9 1.7 12.5 45 0.7 1.4 0.3 1.0 0.6 0.9 12.4 6.7 8.0 9.0 8.2 2.5 3.0 1.8 13.0 47 0.8 1.4 0.3 1.0 0.6 12.8 6.9 8.3 9.4 8.5 2.6 3.2 1.8 3.1 13.4 49 0.8 1.5 0.3 1.1 0.7 1.0 13.3 7.2 8.6 9.7 8.8 2.7 3.3 1.9 13.9 10.0 9.1 2.8 3.4 2.0 51 0.8 1.6 0.3 1.1 0.7 1.0 13.7 7.4 8.9 14.4 10.3 9.4 2.9 3.5 2.0 53 0.9 1.6 0.4 1.2 0.7 1.1 14.1 7.7 9.2 14.8 10.6 9.7 3.0 3.7 2.1 3.6 55 0.9 1.7 0.4 1.2 0.7 1.1 14.6 7.9 9.5 15.2 10.9 9.9 3.1 3.8 2.2 57 0.9 1.7 0.4 1.3 0.8 1.2 15.0 8.2 9.7 15.7 59 0.9 1.8 0.4 1.3 0.8 1.2 1 This column to be used only if brands and tags are not located at the washbasin. This refers to the carcasses in bleeding area. 1 2 points of feet Number between

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(ii) Inspection Using Viscera Table, COWS AND BULLS Tongue-In Presentation of Heads. Number of inspectors by stations STEERS AND HEIFERS Maximum slaughter rates (head per hour) Car- Head Viscera cass Number of inspectors by stations Maximum slaughter rates (head per 1 to 29 ...... a a a hour) Car- 30 to 56 ...... b b b Head Viscera cass 57 to 79 ...... 1 1 1 80 to 98 ...... 1 2 1 1 to 32 ...... a a a 99 to 147 ...... 2 2 1 33 to 58 ...... b b b 148 to 174 ...... 2 3 1 59 to 84 ...... 1 1 1 175 to 205 ...... 3 3 1 206 to 233 ...... 3 4 1 85 to 86 ...... 1 2 1 234 to 256 ...... 3 4 2 87 to 143 ...... 2 2 1 257 to 288 ...... 4 4 2 144 to 171 ...... 3 2 1 289 to 316 ...... 5 4 2 172 to 198 ...... 3 3 1 317 to 343 ...... 5 5 2 199 to 226 ...... 3 3 2 227 to 253 ...... 4 3 2 (3) Swine Inspection. The following in- 254 to 280 ...... 4 4 2 spection staffing standards are applica- 281 to 306 ...... 5 4 2 ble to swine slaughter configurations. 307 to 333 ...... 5 5 2 The inspection standards for all slaughter lines are based upon the ob- COWS AND BULLS servation rather than palpation, at the viscera inspection station, of the Number of inspectors by stations spleen, liver, heart, lungs, and medi- Maximum slaughter rates (head per astinal lymph nodes. In addition, for hour) Car- Head Viscera cass one- and two-inspector lines, the standards are based upon the distance 1 to 29 ...... a a a walked (in feet) by the inspector be- 30 to 56 ...... b b b tween work stations; and for three or 57 to 77 ...... 1 1 1 78 to 81 ...... 1 2 1 more inspector slaughter lines, upon 82 to 134 ...... 2 2 1 the use of a mirror, as described in 135 to 159 ...... 2 3 1 § 307.2(m)(6), at the carcass inspection 160 to 187 ...... 3 3 1 station. Although not required in a 188 to 213 ...... 3 4 1 one- or two-inspector slaughter con- 214 to 234 ...... 3 4 2 figuration, except in certain cases as 235 to 264 ...... 4 4 2 determined by the inspection service, if 265 to 289 ...... 5 4 2 290 to 314 ...... 5 5 2 a mirror is used, it must comply with the requirements of § 307.2(m)(6). (iii) Inspection Using Viscera Table, TABLE 1—ONE INSPECTOR—STAFFING Tongue-Out Presentation of Heads. STANDARDS FOR SWINE

STEERS AND HEIFERS Maximum inspection rates (head per hour) Number of inspectors Market hogs Sows and boars Maximum slaughter rates (head per by stations Distance walked 1 in feet is— (heads attached (heads de- hour) Car- or detached) tached) Head Viscera cass Without With Without With mirror mirror mirror mirror 1 to 32 ...... a a a 33 to 58 ...... b b b 0 to 5 ...... 140 150 131 143 59 to 86 ...... 1 1 1 6 to 10 ...... 134 144 126 137 87 to 103 ...... 1 2 1 11 to 15 ...... 129 137 122 132 104 to 156 ...... 2 2 1 16 to 20 ...... 124 132 117 127 157 to 186 ...... 2 3 1 21 to 35 ...... 120 127 113 122 187 to 216 ...... 3 3 1 26 to 30 ...... 116 122 110 118 31 to 35 ...... 112 118 106 114 217 to 246 ...... 3 3 2 36 to 40 ...... 108 114 103 110 247 to 275 ...... 3 4 2 41 to 45 ...... 105 110 100 106 276 to 304 ...... 4 4 2 46 to 50 ...... 101 107 97 103 305 to 333 ...... 4 5 2 51 to 55 ...... 98 103 94 100 334 to 362 ...... 5 5 2 56 to 60 ...... 96 100 91 97 363 to 390 ...... 5 6 2 61 to 65 ...... 93 97 89 94 66 to 70 ...... 90 95 87 92

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TABLE 1—ONE INSPECTOR—STAFFING TABLE 3—TWO INSPECTORS—STAFFING STANDARDS FOR SWINE—Continued STANDARDS FOR SOWS AND BOARS

Maximum inspection rates (head Maximum inspection rates (head per per hour) hour) Market hogs Sows and boars Line Configuration Distance walked 1 in feet is— (heads attached (heads de- Distance or detached) tached) walked 1 in feet Head, 2 Car- Head, 2 by inspector B Viscera, 2 viscera cass, 2 viscera Without With Without With is— head head car- car- car- mirror mirror mirror mirror cass, 3 cass, 3 viscera, 3 cass, 3 heads heads heads heads 71 to 75 ...... 88 92 85 89 detached de- detached tached attached 76 to 80 ...... 86 89 82 87 81 to 85 ...... 84 87 80 85 Without Mirror 86 to 90 ...... 82 85 79 83 91 to 95 ...... 80 83 77 81 0 to 5 ...... 144–248 144–254 144–267 144–267 96 to 100 ...... 78 81 75 79 6 to 10 ...... 144–235 144–240 144–253 144–253 1 Distance walked is the total distance that the inspector will 11 to 15 ...... 144–222 144–227 144–239 144–239 have to walk between work stations during one inspection 16 to 20 ...... 144–211 144–215 144–226 144–226 cycle (e.g., between viscera, carcass, head, and wash-basin). 21 to 25 ...... 144–201 144–205 144–214 144–214 With Mirror TABLE 2—TWO INSPECTORS—STAFFING STANDARDS FOR MARKET HOGS 0 to 5 ...... 144–248 144–292 144–305 144–292 6 to 10 ...... 144–235 144–273 144–291 144–280 Maximum inspection rates (head 11 to 15 ...... 144–222 144–256 144–272 144–268 per hour with heads attached or 16 to 20 ...... 144–211 144–241 144–255 144–255 detached) 21 to 25 ...... 144–201 144–228 144–240 144–240 Distance walked 1 in feet Line configuration by inspector B is— 1 Distance walked is the total distance that Inspector B will Car- have to walk between work stations during one inspection Viscera, 2 Head, 2 cass, 2 cycle (e.g., between viscera, carcass, and washbasin). head head car- viscera 2 Inspector A. cass 3 carcass 3 viscera 3 3 Inspector B.

Without Mirror NOTE: In multiple-inspector plants, the inspectors must rotate between all inspection 0 to 5 ...... 151–253 151–271 151–296 positions during each shift to equalize the 6 to 10 ...... 151–239 151–255 151–277 workload. 11 to 15 ...... 151–226 151–240 151–260 16 to 20 ...... 151–214 151–227 151–244 TABLE 4—THREE INSPECTORS OR MORE— 21 to 25 ...... 151–204 151–215 151–231 STAFFING STANDARDS FOR SWINE With Mirror Maximum inspection Number of inspectors by station 0 to 5 ...... 151–253 151–303 151–318 rates (head per hour with heads attached) Head Viscera Car- Total 6 to 10 ...... 151–239 151–283 151–304 cass 11 to 15 ...... 151–226 151–265 151–289 16 to 20 ...... 151–214 151–249 151–270 Market hogs: 21 to 25 ...... 151–204 151–235 151–254 319 to 506...... 1 1 1 3 507 to 540...... 1 2 1 4 1 Distance walked is the total distance that Inspector B will 541 to 859...... 2 2 1 5 have to walk between work stations during one inspection cycle (e.g., between viscera, carcass, and washbasin). 860 to 1,022 ...... 2 3 1 6 2 Inspector A. 1,023 to 1,106 ...... 3 3 1 7 3 Inspector B. Sows and boars: 306 to 439...... 1 1 1 3 NOTE: In multiple-inspector plants, the in- 306 to 462 1 ...... 1 1 1 3 spectors must rotate between all inspection 440 to 475...... 2 1 1 4 positions during each shift to equalize the 476 to 752...... 2 2 1 5 workload. 753 to 895...... 3 2 1 6 896 to 964...... 3 3 1 7

1 This rate applies if the heads of sows and boars are detached from the carcasses at the time of inspection.

NOTE: In multiple-inspector plants, the inspectors must rotate between all inspection positions during each shift to equalize the workload. [35 FR 15567, Oct. 3, 1970, as amended at 47 FR 33676, Aug. 4, 1982; 50 FR 19903, May 13, 1985]

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§ 310.2 Identification of carcass with this section if such alternate method certain severed parts thereof and would provide a ready means of identi- with animal from which derived. fying a specific carcass with the cor- (a) The head, tail, tongue, thymus responding devices by a Program in- gland, and all viscera of each slaugh- spector during the post-mortem inspec- tered animal, and all blood and other tion. parts of such animal to be used in the (5) Disposition and use of identifying preparation of meat food products or devices. medical products, shall be handled in (i) The official State-Federal Depart- such a manner as to identify them with ment backtags will be collected by a the rest of the carcass and as being de- Program inspector and used to obtain rived from the particular animal in- traceback information necessary for volved, until the post-mortem exam- proper disposition of the animal or car- ination of the carcass and parts thereof cass and otherwise handled according has been completed. Such handling to instructions issued to the inspec- shall include the retention of ear tags, tors. backtags, implants, and other identi- (ii) The devices described in para- fying devices affixed to the animal, in graph (b)(2) of this section shall be col- such a way to relate them to the car- lected by the Program inspector when cass until the post-mortem examina- required to obtain traceback information has been completed. tion necessary for proper disposition of (b) The official State-Federal Depart- the animal or carcass and for control- ment backtag on any carcass shall: ling the slaughter of reactor animals. (1)(i) Be removed from the hide of the Devices not collected for these pur- animal by an establishment employee poses shall be discarded after the post- and placed in a clear plastic bag. The mortem examination is complete. bag containing the tag shall be affixed (6) Plastic bags used by the establish- to the corresponding carcass. ment for collecting identifying devices (ii) The bag containing the tag shall will be furnished by the Department. be removed from the carcass by an establishment employee and presented [35 FR 15567, Oct. 3, 1970; 36 FR 12004, June 24, with the viscera to the Program in- 1971] spector at the point where such inspec- § 310.3 Carcasses and parts in certain tor conducts the viscera inspection. instances to be retained. (2)(i) Brucellosis and tuberculosis ear tags, herd identification ear tags, sales Each carcass, including all detached tags, ear bangles, and similar identi- organs and other parts, in which any fication devices shall be removed from lesion or other condition is found that the animal’s hide or ear by an estab- might render the meat or any part lishment employee and shall be placed unfit for food purposes, or otherwise in a clear plastic bag and affixed to the adulterated, and which for that reason corresponding carcass. would require a subsequent inspection, (ii) The bag containing the tag shall shall be retained by the Program em- be removed from the carcass by an es- ployee at the time of inspection. The tablishment employee and presented identity of every such retained carcass, with the viscera to the Program in- detached organ, or other part shall be spector at the point where such inspec- maintained until the final inspection tor conducts the viscera inspection. has been completed. Retained carcasses (3) In cases where both types of de- shall not be washed or trimmed unless vices described in paragraphs (b)(1) and authorized by the Program employee. (2) of this section are present on the same animal, both types may be placed § 310.4 Identification of carcasses and in the same plastic bag or in two sepa- parts; tagging. rate bags. Such devices and methods as may be (4) The circuit supervisor may allow approved by the Administrator may be the use of any alternate method pro- used for the temporary identification posed by the operator of an official es- of retained carcasses, organs, and other tablishment for handling the type of parts. In all cases, the identification devices described in paragraph (b)(2) of shall be further established by affixing

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‘‘U.S. Retained’’ tags as soon as prac- ‘‘U.S. Retained’’ tags are attached to ticable and before final inspection. the carcasses, the affected tissues shall These tags shall not be removed except be removed and condemned before the by a Program employee. tags are removed. ‘‘U.S. Retained’’ tags shall be removed only by a Program § 310.5 Condemned carcasses and employee. parts to be so marked; tanking; separation. § 310.9 Anthrax; carcasses not to be Each carcass or part which is found eviscerated; disposition of affected on final inspection to be unsound, carcasses; hides, hoofs, horns, hair, unhealthful, unwholesome, or other- viscera and contents, and fat; han- wise adulterated shall be conspicuously dling of blood and scalding vat marked, on the surface tissues thereof, water; general cleanup and dis- by a Program employee at the time of infection. inspection, as ‘‘U.S. Inspected and Con- (a) Carcasses found before eviscera- demned.’’ Condemned detached organs tion to be affected with anthrax shall and other parts of such character that not be eviscerated but shall be re- they cannot be so marked shall be tained, condemned, and immediately placed immediately in trucks or recep- tanked or otherwise disposed of as pro- tacles which shall be kept plainly vided in part 314 of this subchapter. marked ‘‘U.S. Condemned,’’ in letters (b) All carcasses and all parts, includ- not less than 2 inches high. All con- ing hides, hoofs, horns, hair, viscera demned carcasses and parts shall remain in the custody of a Program em- and contents, blood, and fat of any ployee and shall be disposed of as re- livestock found to be affected with an- quired in the regulations in part 314 of thrax shall be condemned and imme- this subchapter at or before the close diately disposed of as provided in part of the day on which they are con- 314 of this subchapter, except that the demned. blood may be handled through the usual blood cooking and drying equip- § 310.6 Carcasses and parts passed for ment. cooking; marking. (c) Any part of any carcass that is Carcasses and parts passed for cook- contaminated with anthrax-infected ing shall be marked conspicuously on material through contact with soiled the surface tissues thereof by a Pro- instruments or otherwise shall be im- gram employee at the time of inspec- mediately condemned and disposed of tion, ‘‘U.S. Passed for Cooking.’’ All as provided in part 314 of this sub- such carcasses and parts shall be chapter. cooked in accordance with part 315 of (d) The scalding vat water through this subchapter, and until so cooked which hog carcasses affected with an- shall remain in the custody of a Pro- thrax have passed shall be immediately gram employee. drained into the sewer and all parts of § 310.7 Removal of spermatic cords, the scalding vat shall be cleaned and pizzles and preputial diverticuli. disinfected as provided in paragraph (e) of this section. Spermatic cords and pizzles shall be removed from all carcasses. Preputial (e)(1) That portion of the slaugh- diverticuli shall be removed from hog tering department, including the bleed- carcasses. ing area, scalding vat, gambrelling bench, floors, walls, posts, platforms, § 310.8 Passing and marking of car- saws, cleavers, knives, and hooks, as casses and parts. well as employees’ boots and aprons, Carcasses and parts found to be contaminated through contact with an- sound, healthful, wholesome, and oth- thrax-infected material, shall, except erwise not adulterated shall be passed as provided in paragraph (e)(2) of this and marked as provided in part 316 of section be cleaned immediately and this subchapter. In all cases where car- disinfected with one of the following casses showing localized lesions are passed for food or for cooking and

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disinfectants or other disinfectant 1 ap- (3) The first and indispensable pre- proved specifically for this purpose by cautionary step for persons who have the Administrator: handled anthrax material is thorough (i) A 5 percent solution of sodium hy- cleansing of the hands and arms with droxide or commercial lye containing liquid soap and running hot water. It is at least 94 percent of sodium hydrox- important that this step be taken im- ide. The solution shall be freshly pre- mediately after exposure, before vege- pared immediately before use by dis- tative anthrax organisms have had solving 21⁄2 pounds of sodium hydroxide time to form spores. In the cleansing, a or lye in 51⁄2 gallons of hot water and brush or other appropriate appliance shall be applied as near scalding hot as shall be used to insure the removal of possible to be most effective. (Owing to all contaminating material from under the extremely caustic nature of sodium and about the fingernails. This process hydroxide solution, precautionary of cleansing is most effective when per- measures such as the wearing of rubber formed in repeated cycles of lathering gloves and boots to protect the hands and rinsing rather than in spending the and feet, and goggles to protect the same amount of time in scrubbing with eyes, should be taken by those engaged a single lathering. After the hands in the disinfection process. It is also have been cleansed thoroughly and advisable to have an acid solution, rinsed free of soap, they may, if de- such as vinegar, in readiness in case sired, be immersed for about 1 minute any of the sodium hydroxide solution in a 1:1,000 solution of bichloride of should come in contact with any part mercury, followed by thorough rinsing of the body.) in clean running water. Supplies of bi- (ii) A solution of sodium hypochlorite chloride of mercury for the purpose containing approximately one-half of 1 must be held in the custody of the vet- percent (5,000 parts per million) of erinary medical officer. (As a pre- available chlorine. The solution shall cautionary measure, all persons ex- be freshly prepared. posed to anthrax infection should re- (iii) When a disinfectant solution has port promptly any suspicious condition been applied to equipment which will (sore or carbuncle) or symptom to a afterwards contact product, the equip- physician, in order that anti-anthrax ment shall be rinsed with clean water serum or other treatment may be ad- before such contact. ministered as indicated.) (2) In case anthrax infection is found in the hog slaughtering department, an [35 FR 15567, Oct. 3, 1970; 36 FR 11903, June 23, immediate preliminary disinfection 1971] shall be made from the head-dropper’s station to the point where the disease § 310.10 Carcasses with skin or hide on; cleaning before evisceration; re- is detected and the affected carcasses moval of larvae of Hypodermae, ex- shall be cut down from the rail and re- ternal parasites and other patholog- moved from the room. Upon comple- ical skin conditions. tion of the slaughtering of the lot of When a carcass is to be dressed with hogs of which the anthrax-infected ani- the skin or hide left on, the skin or mals were a part, slaughtering oper- hide shall be thoroughly washed and ations shall cease, and a thorough cleanup and disinfection shall be made, cleaned before any incision is made for as provided in paragraph (e)(1) of this the purpose of removing any part section. If the slaughter of the lot has thereof or evisceration, except that not been completed by the close of the where calves are slaughtered by the ko- day on which anthrax was detected, the sher method, the heads shall be re- cleanup and disinfection shall not be moved from the carcasses, before wash- deferred beyond the close of that day. ing of the carcasses. The skin shall be removed at the time of post-mortem inspection from any calf carcass in- 1 A list of disinfectants approved for this fested with the larvae of the purpose is available upon request to the Sci- entific Services, Meat and Poultry Inspec- ‘‘oxwarble’’ fly (Hypoderma lineata and tion, Food Safety and Inspection Service, Hypoderma bovis), or external U.S. Department of Agriculture, Wash- parasites, or affected with other patho- ington, DC 20250. logical skin conditions.

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§ 310.11 Cleaning of hog carcasses be- § 310.15 Disposition of thyroid glands fore incising. and laryngeal muscle tissue. All hair, scurf, dirt, hoofs and claws (a) Livestock thyroid glands and la- shall be removed from hog carcasses, ryngeal muscle tissue shall not be used and the carcasses shall be thoroughly for human food. washed and cleaned before any incision (b) Livestock thyroid glands and la- is made for inspection or evisceration. ryngeal muscle tissue may be distributed to pharmaceutical manufacturers § 310.12 Sternum to be split; abdominal and thoracic viscera to be re- for pharmaceutical use in accordance moved. with § 314.9 or § 325.19(c) of this subchapter, if they are labeled in accord- The sternum of each carcass shall be split and the abdominal and thoracic ance with § 316.13(f) of this subchapter. viscera shall be removed at the time of Otherwise, they shall be disposed of at slaughter in order to allow proper in- the official establishment in accord- spection. ance with § 314.1 or § 314.3 of this subchapter. § 310.13 Inflating carcasses or parts thereof; transferring caul or other [53 FR 45890, Nov. 15, 1988] fat. § 310.16 Disposition of lungs. (a) Establishments that slaughter livestock and prepare livestock car- (a) Livestock lungs shall not be saved casses and parts may inflate carcasses for use as human food. or parts of carcasses with air if they (b) Lungs found to be affected with develop, implement, and maintain con- disease or pathology and lungs found to trols to ensure that the air inflation be adulterated with chemical or bio- procedure does not cause insanitary logical residue shall be condemned and conditions or adulterate product. Es- identified as ‘‘U.S. Inspected and Con- tablishments shall incorporate these demned.’’ Condemned lungs may not be controls into their HACCP plans or saved for pet food or other nonhuman Sanitation SOPs or other prerequisite food purposes. They shall be main- programs. tained under inspectional control and (b)(1) Transferring the caul or other disposed of in accordance with §§ 314.1 fat from a fat to a lean carcass is pro- and 314.3 of this subchapter. hibited. (c) Lungs not condemned under para- (2) Injecting compressed air into the graph (b) of this section may be used in skulls of cattle in conjunction with a the preparation of pet food or for other captive bolt stunner to hold the animal nonhuman food purposes at the official still for dressing operations is prohib- establishment, provided they are han- ited. dled in the manner prescribed in § 318.12 (Approved by the Office of Management and of this subchapter, or they may be dis- Budget under control number 0583–0015) tributed from the establishment in [54 FR 36756, Sept. 5, 1989, as amended at 55 commerce, or otherwise, in accordance FR 29565, July 20, 1990; 69 FR 1891, Jan. 12, with the conditions prescribed in § 325.8 2004; 75 FR 69577, Nov. 15, 2010] of this subchapter for nonhuman food purposes or they may be so distributed § 310.14 Handling of bruised parts. to pharmaceutical manufacturers for When only a portion of a carcass is to pharmaceutical use in accordance with be condemned on account of slight §§ 314.9 and 325.19(b) of this subchapter, bruises, either the bruised portion shall if they are labeled as ‘‘Inedible [SPE- be removed immediately and disposed CIES] Lungs—for Pharmaceutical Use of in accordance with part 314 of this Only.’’ Otherwise, they shall be dis- subchapter, or the carcass shall be posed of at the official establishment, promptly placed in a retaining room in accordance with §§ 314.1 and 314.3 of and kept until chilled and the bruised this subchapter. portion shall then be removed and disposed of as provided in part 314 of this [36 FR 11639, June 17, 1971] subchapter.

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§ 310.17 Inspection of mammary time of slaughter for the purpose of ex- glands. amination by a Program employee. (a) Lactating mammary glands and § 310.20 Saving of blood from livestock diseased mammary glands of cattle, as an edible product. sheep, swine, and goats shall be removed without opening the milk ducts Blood may be saved for edible pur- or sinuses. If pus or other objectionable poses at official establishments pro- material is permitted to come in con- vided it is derived from livestock, the tact with the carcass, the parts of the carcasses of which are inspected and carcass thus contaminated shall be re- passed, and the blood is collected, moved and condemned. defibrinated, and handled in a manner (b) Nonlactating cow udders may be so as not to render it adulterated under saved for food purposes provided suit- the Federal Meat Inspection Act and able facilities for handling and inspect- regulations issued pursuant thereto. ing them are provided. Examination of The defibrination of blood intended for udders by palpation shall be done by a human food purposes shall not be done Program employee. When necessary, in with the hands. Anticoagulants may be the judgment of the Program employee used in accordance with 21 CFR chap- for adequate inspection, the official es- ter I, subchapter A and subchapter B, tablishment employees shall incise or by regulation in 9 CFR chapter III, udders in sections no greater than 2 subchapter A or subchapter E. inches in thickness. All udders showing [64 FR 72174, Dec. 23, 1999] disease lesions shall be condemned by a Program employee. Each udder shall be § 310.21 Carcasses suspected of con- properly identified with its respective taining sulfa and antibiotic resi- carcass and kept separate and apart dues; sampling frequency; disposi- from other udders until its disposal has tion of affected carcasses and parts. been accomplished in accordance with (a) Calf carcasses from animals sus- the provisions of part 311 of this sub- pected of containing biological residues chapter. under § 309.16(d) of this subchapter (c) Lactating mammary glands of shall, on post-mortem inspection, be cattle, sheep, swine, and goats shall handled in accordance with the provi- not be saved for edible purposes. sions of this section. (d) The udders from cows officially (b) For purposes of this section, the designated as ‘‘Brucellosis reactors’’ or following definitions shall apply: as ‘‘Mastitis elimination cows’’ shall be (1) Calf. A calf up to 3 weeks of age or condemned. up to 150 pounds. (2) Certified calf. A calf that the pro- § 310.18 Contamination of carcasses, ducer and all other subsequent organs, or other parts. custodians of the calf certify in writing (a) Carcasses, organs, and other parts has not been treated with any animal shall be handled in a sanitary manner drug while in his or her custody or has to prevent contamination with fecal been treated with one or more drugs in material, urine, bile, hair, dirt, or for- accordance with FDA approved label eign matter; however, if contamination directions while in his or her custody occurs, it shall be promptly removed in and has been withheld from slaughter a manner satisfactory to the inspector. for the period(s) of time specified by (b) Brains, cheek meat, and head those label directions. trimmings from animals stunned by (3) Healthy carcass. A carcass that an lead, sponge iron, or frangible bullets inspector determines shows no lesions shall not be saved for use as human of disease or signs of disease treatment food but shall be handled as described at post-mortem inspection in § 314.1 or § 314.3 of this subchapter. (4) Producer. The owner of the calf at the time of its birth. § 310.19 Inspection of kidneys. (5) Sick calf carcass. A calf carcass An employee of the establishment that an inspector on post-mortem in- shall open the kidney capsule and ex- spection determines has either signs of pose the kidneys of all livestock at the disease treatment or lesions of disease

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or was from an animal identified as (d) Testing of carcasses: sick on ante-mortem. (1) The inspector shall test all car- (6) Sign of treatment. Sign of treat- casses as prescribed in paragraph (c) of ment of a disease is indicated by leak- this section. age around jugular veins, subcuta- (2) Upon initiation of this program at neous, intramuscular or an establishment, the inspector shall intraperitoneal injection lesions, or begin the testing rate for carcasses discoloration from particles or oral from healthy-appearing certified and treatment in any part of the digestive noncertified calves at Level D as pre- tract. scribed in paragraph (c)(4) of this sec- (7) Veterinary medical officer. An in- tion. The inspector shall increase the spector of the Program that has ob- testing rate to the next higher level tained a Doctor of Veterinary Medicine the following business day when three degree which is recognized by the Pro- carcasses in 100 or less consecutively gram. tested show a positive test result for a (c) Selection of carcasses for testing. drug residue. The inspector shall de- The inspector shall perform a swab bio- crease it to the next lower level when assay test 1 on: no more than two calves show a posi- (1) Any carcass from a calf tagged as tive test result for a drug residue in ei- ‘‘U.S. Suspect’’ at the time of ante- ther 500 calves consecutively tested or mortem inspection, except that calves all calves tested over a 60 working day whose carcasses are condemned for pa- period. thology shall not be tested for drug (3) Test results shall be determined residues. by the veterinary medical officer. (2) Any carcass which he/she finds (4) The establishment may designate has either lesions of disease which is one or more of its employees to aid the not condemned because of these lesions inspector in performing the swab bio- or a sign of treatment of disease at the assay test under the supervision of the time of post-mortem inspection, veterinary medical officer who shall in- (3) Any carcass of a calf from a pro- terpret the results, maintain animal ducer whose calf or calves have pre- identification with the test unit, and viously been condemned for residues as ensure integrity of the testing pro- prescribed in paragraph (e) of this sec- gram. tion, and (5) All carcasses and parts thereof (4) Carcasses from healthy-appearing from calves selected for testing shall certified and noncertified calves, as de- be retained until all test results are termined by the veterinary medical of- complete. ficer during ante-mortem inspection, (6) The veterinary medical officer will be selected for testing as set forth shall condemn all carcasses and parts below: thereof for which there are positive test results and release for human con- Sampling Rate (percent of estimated day’s slaughter) sumption all carcasses and parts there- Testing level of for which there are negative test re- Certified Noncertified sults. A ...... 100 100 (7) If there is a positive test result, B ...... 50 50 subsequent calves from the producer of C ...... 20 30 the calf shall be tested in accordance (Start) D ...... 5 10 E ...... 2 5 with paragraph (e) of this section. F ...... 1 2 These test results will not be included in computations to determine an establishment’s compliance record. 1 The procedures for performing the swab (8) The veterinary medical officer bioassay test are set forth in one of two self- may reduce inspection line rates when, instructional guides: ‘‘Performing the in his/her judgment, the prescribed CAST’’ or ‘‘Fast Antimicrobial Screen Test.’’ testing cannot be adequately per- These guides are available for review in the office of the FSIS Docket Clerk, Room 4352 formed within the time available be- South, Food Safety and Inspection Service, cause the establishment’s compliance U.S. Department of Agriculture, Wash- history dictates a need for extensive ington, DC 20250. testing.

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(e) Calves from producers with a pre- segregated from edible materials, and vious residue condemnation. The inspec- disposed of in accordance with § 314.1 or tor shall perform a swab bioassay test § 314.3 of this subchapter. The spinal on all carcasses of all calves in the cord from cattle 30 months of age and group. The veterinary medical officer older must be removed from the car- shall determine the test results and cass at the establishment where the shall condemn any carcass and parts animal was slaughtered. thereof for which there is a positive (d) Requirements for use of the small in- test result and pass for human con- testine for human food. (1) The small in- sumption any such carcass and parts testine from all cattle may be used for thereof for which there is a negative human food if: test result. All subsequent calves from (i) It is derived from cattle that were the same producer which has pre- inspected and passed in an official es- viously sold or delivered to official establishment in the United States or in tablishments any carcass that was con- a certified foreign establishment in a demned because of drug residues must country listed in 9 CFR 327.2(b) as eligi- be tested according to this paragraph ble to export meat and meat products until five consecutive animals test to the United States and it is otherwise completely free of animal drug resi- eligible for importation under 9 CFR dues. 327.1(b), and (f) If the owner or operator of an offi- (ii) The distal ileum is removed by a cial establishment disagrees with the procedure that removes at least 80 veterinary medical officer’s disposition inches of the uncoiled and trimmed of carcasses and parts thereof, the small intestine as measured from the owner or operator may appeal as pro- ceco-colic junction and progressing vided in section 306.5 of this chapter. proximally towards the jejunum or by [50 FR 32164, Aug. 9, 1985, as amended at 52 a procedure that the establishment FR 2104, Jan. 20, 1987; 55 FR 7475, Mar. 2, 1990; demonstrates is effective in ensuring 60 FR 66483, Dec. 22, 1995] complete removal of the distal ileum. § 310.22 Specified risk materials from (iii) If the conditions in paragraphs cattle and their handling and dis- (d)(1)(i) or (ii) of this section are not position. met, the entire small intestine must be (a) The following materials from cat- removed from the carcass, segregated tle are specified risk materials, except from edible materials, and disposed of when they are from cattle from a coun- in accordance with §§ 314.1 or 314.3 of try that can demonstrate that its bo- this subchapter. vine spongiform encephalopathy (BSE) (2) The requirements in paragraph risk status can reasonable be expected (d)(1) of this section do not apply to to provide the same level of protection materials from cattle from countries from human exposure to the BSE agent that can demonstrate that their BSE as prohibiting specified risk materials risk status can reasonably be expected for use as human food does in the to provide the same level of protection United States: from human exposure to the BSE agent (1) The brain, skull, eyes, trigeminal as prohibiting specified risk materials ganglia, spinal cord, vertebral column for use as human food does in the (excluding the vertebrae of the tail, the United States. transverse processes of the thoracic (e) Procedures for the removal, segrega- and lumbar vertebrae, and the wings of tion, and disposition of specified risk ma- the sacrum), and dorsal root ganglia terials. (1) Establishments that slaugh- from cattle 30 months of age and older ter cattle and establishments that and process the carcasses or parts of cattle (2) The distal ileum of the small in- must develop, implement, and main- testine and the tonsils from all cattle. tain written procedures for the re- (b) Specified risk materials are ined- moval, segregation, and disposition of ible and prohibited for use as human specified risk materials. These proce- food. dures must address potential contami- (c) Specified risk materials must be nation of edible materials with speci- removed from the carcasses of cattle, fied risk materials before, during, and

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after entry into the establishment. Es- such records can be made available to tablishments must incorporate their FSIS within 24 hours of request. procedures for the removal, segrega- (f) Sanitation of equipment used to cut tion, and disposition of specified risk through specified risk materials. (1) If an materials into their HACCP plans or establishment that slaughters cattle, Sanitation SOPs or other prerequisite or that processes the carcasses or parts programs. from cattle, does not segregate the car- (2) Establishments that slaughter casses and parts from cattle 30 months cattle and establishments that process of age and older from the carcasses and the carcasses or parts of cattle must parts from cattle younger than 30 take appropriate corrective action months during processing operations it when either the establishment or FSIS must: determines that the establishment’s (i) Use dedicated equipment to cut procedures for the removal, segrega- through specified risk materials; or tion, and disposition of specified risk (ii) Clean and sanitize equipment materials, or the implementation or used to cut through specified risk ma- maintenance of these procedures, have terials before the equipment is used on failed to ensure that specified risk ma- carcasses or parts from cattle younger terials are adequately and effectively than 30 months of age. removed from the carcasses of cattle, (2) If an establishments that slaugh- segregated from edible materials, and disposed of in accordance with para- ters cattle, or that process the car- graph (c) of this section. casses or parts from cattle, segregates the carcasses and parts of cattle 30 (3) Establishments that slaughter months of age and older from cattle cattle and establishments that process younger than 30 months of age during the carcasses or parts of cattle must processing operations, and processes routinely evaluate the effectiveness of the carcasses or parts from the cattle their procedures for the removal, segregation, and disposition of specified younger than 30 months first, it may risk materials in preventing the use of use routine operational sanitation pro- these materials for human food and cedures on equipment used to cut must revise the procedures as nec- through specified risk materials. essary whenever any changes occur (g) Slaughter establishments may that could affect the removal, segrega- ship beef carcasses or parts that con- tion, and disposition of specified risk tain vertebral columns from cattle 30 materials. months of age and older to another fed- (4) Recordkeeping requirements. (i) Es- erally-inspected establishment for fur- tablishments that slaughter cattle and ther processing if the establishment establishments that process the car- shipping these materials: casses or parts of cattle must maintain (1) Maintains control of the carcasses daily records sufficient to document or parts while they are in transit or en- the implementation and monitoring of sures that the carcasses or parts move the procedures for the removal, seg- under FSIS control; regation, and disposition of the mate- (2) Ensures that the carcasses or rials listed in paragraph (a) of this sec- parts are accompanied by documentation, and any corrective actions taken. tion that clearly states that the car- (ii) Records required by this section casses or parts contain vertebral col- may be maintained on computers pro- umns from cattle that were 30 months vided that the establishment imple- of age and older at the time of slaugh- ments appropriate controls to ensure ter; the integrity of the electronic data. (3) Maintains records that identify (iii) Records required by this section the official establishment that received must be retained for at least one year the carcasses or parts; and must be accessible to FSIS. All (4) Maintains records that verify that such records must be maintained at the the official establishment that received official establishment for 48 hours fol- the carcasses or parts removed the por- lowing completion, after which they tions of the vertebral column des- may be maintained off-site provided ignated as specified risk materials in

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paragraph (a)(1) of this section and dis- collection procedures which shall iden- posed of them in accordance with § 314.1 tify employees designated to collect or § 314.3 of this subchapter. samples, and shall address location(s) (h) The materials listed in paragraph of sampling, how sampling randomness (a)(1) of this section will be deemed to is achieved, and handling of the sample be from cattle 30 months of age and to ensure sample integrity. The writ- older unless the establishment can ten procedure shall be made available demonstrate through documentation to FSIS upon request. that the materials are from an animal (ii) Sample collection. The establish- that was younger than 30 months of ment must collect samples from all age at the time of slaughter. chilled livestock carcasses, except [72 FR 38729, July 13, 2007] those boned before chilling (hot-boned), which must be sampled after the final § 310.23 Identification of carcasses and wash. Samples must be collected in the parts of swine. following manner; (a) The identification of the car- (A) For cattle, establishments must casses and parts of swine identified in sponge or excise tissue from the flank, accordance with part 71 of this title brisket and rump, except for hide-on shall be made available to the inspec- calves, in which case establishments tor upon the inspector’s request must take samples by sponging from throughout post-mortem inspection. inside the flank, inside the brisket, and (b) If the establishment fails to pro- inside the rump. vide required swine identification, the (B) For sheep, goat, horse, mule, or inspector shall order the retention of other equine carcasses, establishments swine caracasses at the establishment must sponge from the flank, brisket until the completion of tests to con- and rump, except for hide-on carcasses, firm that the carcasses are not adulter- in which case establishments must ated. take samples by sponging from inside the flank, inside the brisket, and inside [53 FR 40387, Oct. 14, 1988] the rump. § 310.24 [Reserved] (C) For swine carcasses, establishments must sponge or excise tissue § 310.25 Contamination with micro- from the ham, belly and jowl areas. organisms; process control (iii) Sampling frequency. Slaughter es- verification criteria and testing; tablishments, except very low volume pathogen reduction standards. establishments as defined in paragraph (a) Criteria for verifying process con- (a)(2)(v) of this section, must take sam- trol; E. coli testing. (1) Each official es- ples at a frequency proportional to the tablishment that slaughters livestock volume of production at the following must test for Escherichia coli Biotype 1 rates: (E.coli) Establishments that slaughter (A) Cattle, sheep, goats, horses, more than one type of livestock or mules, and other equines: 1 test per 300 both livestock and poultry, shall test carcasses, but, a minimum of one sam- the type of livestock or poultry slaugh- ple during each week of operation. tered in the greatest number. The es- Swine: 1 test per 1,000 carcasses, but tablishment shall: a minimum of one sample during each (i) Collect samples in accordance week of operation. with the sampling techniques, method- (iv) Sampling frequency alternatives. ology, and frequency requirements in An establishment operating under a paragraph (a)(2) of this section; validated HACCP plan in accordance (ii) Obtain analytic results in accord- with § 417.2(b) of this chapter may sub- ance with paragraph (a)(3) of this sec- stitute an alternative frequency for the tion; and frequency of sampling required under (iii) Maintain records of such ana- paragraph (a)(2)(iii) of this section if, lytic results in accordance with para- (A) The alternative is an integral graph (a)(4) of this section. part of the establishment’s verification (2) Sampling requirements. procedures for its HACCP plan and, (i) Written procedures. Each establish- (B) FSIS does not determine, and no- ment shall prepare written specimen tify the establishment in writing, that

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the alternative frequency is inadequate have been made requiring resumption to verify the effectiveness of the estab- of weekly testing shall be provided to lishment’s processing controls. the establishment in writing. (v) Sampling in very low volume estab- (3) Analysis of samples. Laboratories lishments. (A) Very low volume estab- may use any quantitative method for lishments annually slaughter no more analysis of E. coli that is approved as than 6,000 cattle, 6,000 sheep, 6,000 an AOAC Official Method of the AOAC goats, 6,000 horses, mules or other International (formerly the Associa- equines, 20,000 swine, or a combination tion of Official Analytical Chemists) 2 of livestock not exceeding 6,000 cattle or approved and published by a sci- and 20,000 total of all livestock. Very entific body and based on the results of low volume establishments that collect a collaborative trial conducted in ac- samples by sponging shall collect at cordance with an internationally rec- least one sample per week, starting the ognized protocol on collaborative trials first full week of operation after June and compared against the three tube 1 of each year, and continue sampling Most Probable Number (MPN) method at a minimum of once each week the and agreeing with the 95 percent upper establishment operates until June 1 of and lower confidence limit of the ap- the following year or until 13 samples propriate MPN index. have been collected, whichever comes (4) Recording of test results. The estab- first. Very low volume establishments lishment shall maintain accurate collecting samples by excising tissue records of all test results, in terms of from carcasses shall collect one sample CFU/cm2 of surface area sponged or per week, starting the first full week of excised. Results shall be recorded onto operation after June 1 of each year, a process control chart or table show- and continue sampling at a minimum ing at least the most recent 13 test re- of once each week the establishment sults, by type of livestock slaughtered. operates until one series of 13 tests Records shall be retained at the estab- meets the criteria set forth in para- lishment for a period of 12 months and graph (a)(5)(i) of this section. shall be made available to FSIS upon (B) Upon the establishment’s meeting request. requirements of paragraph (a)(2)(v)(A) (5) Criteria for evaluation of test results. of this section, weekly sampling and (i) An establishment excising samples testing is optional, unless changes are from carcasses is operating within the made in establishment facilities, equip- criteria when the most recent E. coli ment, personnel or procedures that test result does not exceed the upper may affect the adequacy of existing limit (M), and the number of samples, process control measures, as deter- if any, testing positive at levels above mined by the establishment or FSIS. (m) is three or fewer out of the most FSIS determinations that changes recent 13 samples (n) taken, as follows:

TABLE 1—EVALUATION OF E. COLI TEST RESULTS

Lower limit of Upper limit of Number of sample Maximum number permitted in Type of livestock marginal range marginal range tested marginal range (m) (M) (n) (c)

Cattle ...... Negative a ...... 100 CFU/cm 2 ...... 13 3 Swine ...... 10 CFU/cm 2 ...... 10,000 CFU/cm 2 ...... 13 3 a Negative is defined by the sensitivity of the method used in the baseline study with a limit of sensitivity of at least 5 cfu/cm2 carcass surface area.

(ii) Establishments sponging car- using statistical process control tech- casses shall evaluate E. coli test results niques.

2 A copy of the current edition/revision of eral Register, and may be purchased from the ‘‘Official Methods of AOAC Inter- the Association of Official Analytical Chem- national,’’ 16th edition, 3rd revision, 1997, is ists International, Inc., 481 North Frederick on file with the Director, Office of the Fed- Ave., Suite 500, Gaithersburg, MD 20877–2417.

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(6) Failure to meet criteria. Test results test results and other information con- that do not meet the criteria described cerning the establishment’s perform- in paragraph (a)(5) of this section are ance. In an establishment producing an indication that the establishment more than one class of product subject may not be maintaining process con- to the pathogen reduction standard, trols sufficient to prevent fecal con- FSIS may sample any or all such class- tamination. FSIS shall take further ac- es of products. 3 tion as appropriate to ensure that all (3) Noncompliance and establishment applicable provisions of the law are response. When FSIS determines that being met. an establishment has not met the per- (7) Failure to test and record. Inspec- formance standard: tion shall be suspended in accordance (i) The establishment shall take im- with rules of practice that will be mediate action to meet the standard. adopted for such proceedings upon a (ii) If the establishment fails to meet finding by FSIS that one or more pro- the standard on the next series of com- visions of paragraphs (a) (1)–(4) of this pliance tests for that product, the es- section have not been complied with tablishment shall reassess its HACCP and written notice of same has been plan for that product and take appro- provided to the establishment. priate corrective actions. (b) Pathogen reduction performance (iii) Failure by the establishment to standard; Salmonella—(1) Raw meat act in accordance with paragraph product performance standards for Sal- (b)(3)(ii) of this section, or failure to monella. An establishment’s raw meat meet the standard on the third con- products, when sampled and tested by secutive series of FSIS-conducted tests FSIS for Salmonella, as set forth in this for that product, constitutes failure to section, may not test positive for Sal- maintain sanitary conditions and fail- monella at a rate exceeding the applica- ure to maintain an adequate HACCP ble national pathogen reduction per- plan, in accordance with part 417 of formance standard, as provided in this chapter, for that product, and will Table 2: cause FSIS to suspend inspection services. Such suspension will remain in ef- TABLE 2—SALMONELLA PERFORMANCE fect until the establishment submits to STANDARDS the FSIS Administrator or his/her designee satisfactory written assurances Perform- Maximum detailing the action taken to correct ance Stand- Number of number of the HACCP system and, as appropriate, Class of product ard (percent samples positives to positive for tested achieve other measures taken by the establish- a (n) Standard Salmonella) (c) ment to reduce the prevalence of pathogens. Steers/heifers ...... 1.0% 82 1 Cows/bulls ...... 2.7% 58 2 [61 FR 38864, July 25, 1996, as amended at 62 Ground beef ...... 7.5% 53 5 FR 26217, May 13, 1997; 63 FR 1735, Jan. 12, Hogs ...... 8.7% 55 6 1998;64 FR 66553, Nov. 29, 1999] Fresh pork sau- b sages ...... N.A. N.A. N.A. PART 311—DISPOSAL OF DISEASED a Performance Standards are FSIS’s calculation of the national prevalence of Salmonella on the indicated raw product OR OTHERWISE ADULTERATED based on data developed by FSIS in its nationwide microbiological data collection programs and surveys. Copies of CARCASSES AND PARTS Reports on FSIS’s Nationwide Microbiological Data Collection Programs and Nationwide Microbiological Surveys used in de- Sec. termining the prevalence of Salmonella on raw products are available in the FSIS Docket Room. 311.1 Disposal of diseased or otherwise adul- b Not available; values for fresh pork sausage will be added terated carcasses and parts; general. upon completion data collection programs for those products. 311.2 Tuberculosis. (2) Enforcement. FSIS will sample and 311.3 Hog cholera. 311.5 Swine erysipelas. test raw meat products in an individual 311.6 Diamond-skin disease. establishment on an unannounced basis to determine prevalence of Salmonella 3 A copy of FSIS’s ‘‘Sample Collection in such products to determine compli- Guidelines and Procedure for Isolation and ance with the standard. The frequency Identification of Salmonella from Meat and and timing of such testing will be Poultry Products’’ is available for inspection based on the establishment’s previous in the FSIS Docket Room.

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311.7 Arthritis. AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, 311.8 Cattle carcasses affected with 2.55. anasarca or generalized edema. SOURCE: 35 FR 15569, Oct. 3, 1970, unless 311.9 Actinomycosis and actinobacillosis. otherwise noted. 311.10 Anaplasmosis, anthrax, babesiosis, bacillary hemoglobinuria in cattle, blackleg, bluetongue, hemorrhagic septi- § 311.1 Disposal of diseased or other- cemia, icterohematuria in sheep, infec- wise adulterated carcasses and tious bovine rhinotracheitis, lepto- parts; general. spirosis, malignant epizootic catarrh, (a) The carcasses or parts of car- strangles, purpura hemorrhagica, casses of all animals slaughtered at an azoturia, infectious equine official establishment and found at the encephalomyelitis, toxic time of slaughter or at any subsequent encephalomyelitis (forage poisoning), infectious anemia (swamp fever), dourine, inspection to be affected with any of acute influenza, generalized osteoporosis, the diseases or conditions named in glanders (farcy), acute inflammatory this part shall be disposed of according lameness, extensive fistula, and unhealed to the section pertaining to the disease vaccine lesions. or condition: Provided, That no product 311.11 Neoplasms. shall be passed for human food under 311.12 Epithelioma of the eye. any such section unless it is found to 311.13 Pigmentary conditions; melanosis, be otherwise not adulterated. Products xanthosis, ochronosis, etc. passed for cooking or refrigeration 311.14 Abrasions, bruises, abscesses, pus, etc. under this part must be so handled at 311.15 Brucellosis. the official establishment where they 311.16 Carcasses so infected that consump- are initially prepared unless they are tion of the meat may cause food poi- moved to another official establish- soning. ment for such handling or in the case 311.17 Necrobacillosis, pyemia, and septi- of products passed for refrigeration are cemia. moved for such refrigeration to a freez- 311.18 Caseous lymphadenitis. ing facility approved by the Adminis- 311.19 Icterus. 311.20 Sexual odor of swine. trator in specific cases: Provided, That 311.21 Mange or scab. when so moved the products are 311.22 Hogs affected with urticaria, tinea shipped in containers sealed in accord- tonsurans, demodex follicurlorum, or erance with § 318.10(c) of this subchapter ythema. or in a sealed means of conveyance as 311.23 Tapeworm cysts (cysticercus bovis) in provided in § 325.7 of this subchapter. cattle. Owning to the fact that it is impracti- 311.24 Hogs affected with tapeworm cysts. cable to formulate rules covering every 311.25 Parasites not transmissible to man; case and to designate at just what tapeworm cysts in sheep; hydatid cysts; flukes; gid bladder-worms. stage a disease process or a condition 311.26 Emaciation. results in adulteration of a product, 311.27 Injured animals slaughtered at un- the decision as to the disposal of all usual hours. carcasses, organs, or other parts not 311.28 Carcasses of young calves, pigs, kids, specifically covered in this part shall lambs, and foals. be left to the veterinary medical offi- 311.29 Unborn and stillborn animals. cer. The veterinary medical officer 311.30 Livestock suffocated and hogs scalded shall exercise his judgment regarding alive. 311.31 Livers affected with carotenosis; liv- the disposition of all carcasses or parts ers designated as ‘‘telangiectatic,’’ of carcasses under this part in a man- ‘‘sawdust,’’ or ‘‘spotted.’’ ner which will insure that only whole- 311.32 Vesicular diseases. some, unadulterated product is passed 311.33 Listeriosis. for human food. 311.34 Anemia. (b) In cases of doubt as to a condi- 311.35 Muscular inflammation, degeneration, a disease, or the cause of a condition, or infiltration. tion, or to confirm a diagnosis, rep- 311.36 Coccidioidal granuloma. resentative specimens of the affected 311.37 Odors, foreign and urine. 311.38 Meat and meat byproducts from live- tissues, properly prepared and pack- stock which have been exposed to radi- aged, shall be sent for examination to ation. one of the laboratories of the Biologi- 311.39 Biological residues. cal Control Section of the Program.

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§ 311.2 Tuberculosis. erinarian 1 is found free of tuberculosis lesions during postmortem inspection. The following principles shall apply (d) Portions of carcasses and carcasses to the disposition of carcasses of live- of cattle passed for cooking. (1) When a stock based on the difference in the cattle carcass reveals a tuberculosis le- pathogenesis of tuberculosis in swine, sion or lesions not so severe or so nu- cattle, sheep, goats, and equines. merous as the lesions described in (a) Carcasses condemned. The entire paragraph (a) of this section, the unaf- carcass of swine, cattle, sheep, goats, fected portion of the carcass may be and equines shall be condemned if any passed for cooking in accordance with of the following conditions occur: part 315 of this chapter; if the char- (1) When the lesions of tuberculosis acter and extent of the lesions indicate are generalized (tuberculosis is consid- a localized condition, and if the lesions ered to be generalized when the lesions are calcified or encapsulated, and pro- are distributed in a manner made pos- vided the affected organ or other part sible only by entry of the bacilli into is condemned. the systemic circulation); (2) When the carcass of a cattle iden- (2) When on ante mortem inspection tified as a reactor to a tuberculin test the animal is observed to have a fever administered by an Animal and Plant found to be associated with an active Health Inspection Service, State or accredited veterinarian is found free of tuberculosis lesion on post mortem in- lesions of tuberculosis, the carcass may spection; be passed for cooking in accordance (3) When there is an associated with part 315 of this chapter. cachexia; (e) Portions of carcasses and carcasses (4) When a tuberculosis lesion is of swine passed without restriction for found in any muscle or intermuscular human food. Swine carcasses found free tissue, or bone, or joint, or abdominal of tuberculosis lesions during post organ (excluding the gastrointestinal mortem inspection may be passed for tract) or in any lymph node as a result human food without restriction. When of draining a muscle, bone, joint, or ab- tuberculosis lesions in any swine car- dominal organ (excluding the gastro- cass are localized and confined to one intestinal tract); primary seat of infection, such as the (5) When the lesions are extensive in cervical lymph nodes, the mesenteric tissues of either the thoracic or the ab- lymph nodes, or the mediastinal lymph dominal cavity; nodes, the unaffected portion of the (6) When the lesions are multiple, carcass may be passed for human food acute, and actively progressive; or without restriction after the affected (7) When the character or extent of organ or other part is condemned. (f) Portions of carcasses of swine passed the lesions otherwise is not indicative for cooking. When the carcass of any of a localized condition. swine reveals lesions more severe or (b) Organs or other parts condemned. more numerous than those described in An organ or other part of a swine, cat- paragraph (e) of this section, but not so tle, sheep, goat, or equine carcass af- severe or so numerous as the lesions fected by localized tuberculosis shall described in paragraph (a) of this sec- be condemned when it contains lesions tion, the unaffected portions of such of tuberculosis or when the cor- carcass may be passed for cooking in responding lymph node contains le- accordance with part 315 of this chap- sions of tuberculosis. ter; if the character and extent of the (c) Carcasses of cattle passed without lesions indicate a localized condition, restriction for human food. Carcasses of and if the lesions are calcified or en- cattle may be passed without restric- capsulated, and provided the affected tion for human food only when the car- organ or other part is condemned. cass of an animal not identified as a reactor to a tuberculin test administered 1 Such testing is conducted in the tuber- by an Animal and Plant Health Inspec- culosis eradication program of the Animal tion Service, State, or accredited vet- and Plant Health Inspection Service, U.S. Department of Agriculture.

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(g) Carcasses of sheep, goats, and control of swine diseases in the State equines passed without restriction for where the swine are located. human food. Carcasses of sheep, goats, [35 FR 15569, Oct. 3, 1970, as amended at 40 FR and equines may be passed without re- 27225, June 27, 1975] striction for human food only if found free of tuberculosis lesions during post § 311.5 Swine erysipelas. mortem inspection. Carcasses affected with swine ery- (h) Portions of carcasses of sheep, goats, sipelas which is acute or generalized, and equines passed for cooking. If a car- or which show systemic change, shall cass of any sheep, goat, or equine re- be condemned. veals a tuberculosis lesion or lesions that are not so severe or so numerous § 311.6 Diamond-skin disease. as the lesions described in paragraph Carcasses of hogs affected with dia- (a) of this section, the unaffected por- mond-skin disease when localized and tion of the carcass may be passed for not associated with systemic change cooking in accordance with part 315 of may be passed for human food after re- this chapter; if the character and ex- moval and condemnation of the af- tent of the lesions indicate a localized fected parts, provided such carcasses condition, and if the lesions are calci- are otherwise healthy. fied or encapsulated, and provided the affected organ or other part is con- § 311.7 Arthritis. demned. (a) Carcasses affected with arthritis [37 FR 2661, Feb. 4, 1972; 38 FR 29214, Oct. 23, which is localized and not associated 1973] with systemic change may be passed for human food after removal and con- § 311.3 Hog cholera. demnation of all affected parts. Af- (a) The carcasses of all hogs affected fected joints with corresponding lymph with hog cholera shall be condemned. nodes shall be removed and condemned. In order to avoid contamination of the (b) Inconclusive but suspicious symp- meat which is passed, a joint capsule toms of hog cholera observed during shall not be opened until after the af- the ante-mortem inspection of a U.S. fected joint is removed. suspect shall be duly considered in con- (b) Carcasses affected with arthritis nection with post-mortem findings and shall be condemned when there is evi- when the carcass of such a suspect dence of systemic involvement. shows lesions in the kidneys and the lymph nodes which resemble lesions of § 311.8 Cattle carcasses affected with hog cholera, they shall be regarded as anasarca or generalized edema. those of hog cholera and the carcass (a) Carcasses of cattle found on post- shall be condemned. mortem inspection to be affected with (c) When lesions resembling those of anasarca in advanced stages and char- hog cholera occur in kidneys and acterized by an extensive or well- lymph nodes of carcasses of hogs which marked generalized edema shall be appeared normal on ante-mortem in- condemned. spection, further inspection of such (b) Carcasses of cattle, including carcasses shall be made for corrobora- their detached organs and other parts, tive lesions. If on such further inspec- found on post-mortem inspection to be tion, characteristic lesions of hog chol- affected with anasarca to a lesser ex- era are found in some organ or tissue tent than as described in paragraph (a) in addition to those in the kidneys or of this section may be passed for in the lymph nodes or in both, then all human food after removal and con- lesions shall be regarded as those of demnation of the affected tissues, pro- hog cholera and the carcass shall be vided the lesion is localized. condemned. Immediate notification shall be given by the inspector to the § 311.9 Actinomycosis and actinobacil- official in the Veterinary Services unit losis. of the Animal and Plant Health Inspec- (a) The definition of generalization tion Service who has responsibility for as outlined for tuberculosis in § 311.2(a)

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shall apply for actinomycosis and acti- (6) Azoturia. nobacillosis, and carcasses of livestock (7) Infectious equine encephalomye- with generalized lesions of either such litis. disease shall be condemned. (8) Toxic encephalomyelitis (forage (b) Carcasses of livestock in a well- poisoning). nourished condition showing uncompli- (9) Infectious anemia (swamp fever). cated localized lesions of actinomy- (10) Dourine. cosis or actinobacillosis may be passed (11) Acute influenza. for human food after the infected or- (12) Generalized osteoporosis. gans or other infected parts have been (13) Glanders (farcy). removed and condemned, except as pro- (14) Acute inflammatory lameness. vided in paragraphs (c) and (d) of this (15) Extensive fistula. section. (b) Carcasses of livestock affected (c) Heads affected with actinomy- with or showing lesions of any of the cosis or actinobacillosis, including the following named diseases or conditions tongue, shall be condemned, except shall be condemned, except when re- that when the disease of the jaw is covery has occurred to the extent that slight, strictly localized, and without only localized lesions persist, in which suppuration, fistulous tracts, or lymph case the carcass may be passed for node involvement, the tongue, if free human food after removal and con- from disease, may be passed, or, when demnation of the affected organs or the disease is slight and confined to the other parts: lymph nodes, the head including the (1) Anaplasmosis. tongue, may be passed for human food (2) Bacillary hemoglobinuria in cat- after the affected nodes have been re- tle. moved and condemned. (3) Babesiosis (piroplasmosis). (d) When the disease is slight and (4) Bluetongue. confined to the tongue, with or without (5) Hemorrhagic septicemia. involvement of the corresponding (6) Icterohematuria in sheep. lymph nodes, the head may be passed (7) Infectious bovine rhinotracheitis. for human food after removal and con- (8) Leptospirosis. demnation of the tongue and cor- (9) Malignant epizootic catarrh. responding lymph nodes. [35 FR 15569, Oct. 3, 1970, as amended at 36 FR 12004, June 24, 1971] § 311.10 Anaplasmosis, anthrax, babesiosis, bacillary hemo- § 311.11 Neoplasms. globinuria in cattle, blackleg, bluetongue, hemorrhagic septi- (a) An individual organ or other part cemia, icterohematuria in sheep, in- of a carcass affected with a neoplasm fectious bovine rhinotracheitis, lep- shall be condemned. If there is evi- tospirosis, malignant epizootic ca- dence of metastasis or that the general tarrh, strangles, purpura condition of the animal has been ad- hemorrhagica, azoturia, infectious versely affected by the size, position, equine encephalomyelitis, toxic or nature of the neoplasm, the entire encephalomyelitis (forage poi- carcass shall be condemned. soning), infectious anemia (swamp fever), dourine, acute influenza, (b) Carcasses affected with malignant generalized osteoporosis, glanders lymphoma shall be condemned. (farcy), acute inflammatory lameness, extensive fistula, and § 311.12 Epithelioma of the eye. unhealed vaccine lesions. (a) Carcasses of animals affected with (a) Carcasses of livestock affected epithelioma of the eye, or the orbital with or showing lesions of any of the region shall be condemned in their en- following named diseases or conditions tirety if one of the following three con- shall be condemned: ditions exists: (1) Anthrax. (1) The affection has involved the os- (2) Blackleg. seous structures of the head with ex- (3) Unhealed vaccine lesions tensive infection, suppuration, and ne- (vaccinia). crosis; (4) Strangles. (2) There is metastasis from the eye, (5) Purpura hemorrhagica. or the orbital region, to any lymph

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node including the parotid lymph node, ucts thereof may give rise to food poi- internal organs, muscles, skeleton, or soning shall be condemned. This in- other structures, regardless of the ex- cludes all carcasses showing signs of: tent of the primary tumor; or (1) Acute inflammation of the lungs, (3) The affection, regardless of ex- pleura, pericardium, peritoneum, or tent, is associated with cachexia or evi- meninges. dence of absorption or secondary (2) Septicemia or pyemia, whether changes. puerperal, traumatic, or without any (b) Carcasses of animals affected with evident cause. epithelioma of the eye, or the orbital (3) Gangrenous or severe hemorrhagic region, to a lesser extent than as de- enteritis or gastritis. scribed in paragraph (a) of this section (4) Acute diffuse metritis or may be passed for human food after re- mammitis. moval and condemnation of the head, (5) Phlebitis of the umbilical veins. including the tongue, provided the car- (6) Septic or purulent traumatic peri- cass is otherwise normal. carditis. (7) Any acute inflammation, abscess, § 311.13 Pigmentary conditions; mela- or suppurating sore, if associated with nosis, xanthosis, ochronosis, etc. acute nephritis, fatty and degenerated (a) Except as provided in § 311.19, car- liver, swollen soft spleen, marked pul- casses of livestock showing generalized monary hyperemia, general swelling of pigmentary deposits shall be con- lymph nodes, diffuse redness of the demned. skin, cachexia, icteric discoloration of (b) The affected parts of carcasses the carcass or similar condition, either showing localized pigmentary deposits singly or in combination. of such character as to be unwholesome (8) Salmonellosis. or otherwise adulterated shall be re- (b) Implements contaminated by con- moved and condemned. tact with carcasses affected with any of the disease conditions mentioned in § 311.14 Abrasions, bruises, abscesses, this section shall be thoroughly pus, etc. cleaned and sanitized as prescribed in All slight, well-limited abrasions on part 308 of this subchapter. The equip- the tongue and inner surface of the lips ment used in the dressing of such car- and mouth, when without lymph node casses, such as viscera trucks or in- involvement, shall be carefully excised, spection tables, shall be sanitized with leaving only sound, normal tissue, hot water having a minimum tempera- which may be passed for human food. ture of 180 °F. Carcasses or parts of car- Any organ or other part of a carcass casses contaminated by contact with which is badly bruised or which is af- such diseased carcasses shall be con- fected by an abscess, or a suppurating demned unless all contaminated tissues sore shall be condemned; and when the are removed within 2 hours. lesions are of such character or extent as to affect the whole carcass, the § 311.17 Necrobacillosis, pyemia, and whole carcass shall be condemned. Por- septicemia. tions of carcasses which are contami- From the standpoint of meat inspec- nated by pus or other diseased material tion, necrobacillosis may be regarded shall be condemned. as a local infection at the beginning, and carcasses in which the lesions are § 311.15 Brucellosis. localized may be passed for human food Carcasses affected with localized le- if in a good state of nutrition, after sions of brucellosis may be passed for those portions affected with necrotic human food after the affected parts are lesions are removed and condemned. removed and condemned. However, when emaciation, cloudy swelling of the parenchymatous tissue § 311.16 Carcasses so infected that con- of organs or enlargement of the lymph sumption of the meat may cause nodes is associated with the infection, food poisoning. it is evident that the disease has pro- (a) All carcasses of animals so in- gressed beyond the condition of local- fected that consumption of the prod- ization to a state of toxemia, and the

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entire carcass shall therefore be con- § 311.20 Sexual odor of swine. demned as both unwholesome and nox- (a) Carcasses of swine which give off ious. Pyemia or septicemia may inter- a pronounced sexual odor shall be con- vene as a complication of the local ne- demned. crosis, and when present the carcass (b) The meat of swine carcasses shall be condemned in accordance with which give off a sexual odor less than § 311.16. pronounced may be passed for use in comminuted cooked meat food product § 311.18 Caseous lymphadenitis. or for rendering. Otherwise it shall be (a) A thin carcass showing well- condemned. marked lesions in the viscera and the skeletal lymph nodes, or a thin carcass § 311.21 Mange or scab. showing extensive lesions in any part Carcasses of livestock affected with shall be condemned. mange or scab in advanced stages, (b) A thin carcass showing well- showing cachexia or extensive inflam- marked lesions in the viscera with only mation of the flesh, shall be con- slight lesions elsewhere or showing demned. When the disease is slight, the well-marked lesions in the skeletal carcass may be passed after removal of lymph nodes with only slight lesions the affected portion. elsewhere may be passed for cooking. (c) A thin carcass showing only slight § 311.22 Hogs affected with urticaria, lesions in the skeletal lymph nodes and tinea tonsurans, demodex follicurlorum, or erythema. in the viscera may be passed for human food without restriction. Carcasses of hogs affected with urti- (d) A well-nourished carcass showing caria (nettle rash), tinea tonsurans, well-marked lesions in the viscera and demodex folliculorum, or erythema with only slight lesions elsewhere or may be passed for human food after de- showing well-marked lesions confined taching and condemning the affected to the skeletal lymph nodes with only skin, if the carcass is otherwise not slight lesions elsewhere may be passed adulterated. for human food without restriction. § 311.23 Tapeworm cysts (cysticercus (e) A well-nourished carcass showing bovis) in cattle. well-marked lesions in the viscera and (a) Except as provided in paragraph the skeletal lymph nodes may be (b) of this section, carcasses of cattle passed for cooking; but where the le- affected with lesions of cysticercus sions in a well-nourished carcass are bovis shall be disposed of as follows: both numerous and extensive, it shall (1) Carcasses of cattle displaying le- be condemned. sions of cysticercus bovis shall be con- (f) All affected organs and nodes of demned if the infestation is extensive carcasses passed for human food with- or if the musculature is edematous or out restriction or passed for cooking discolored. Carcasses shall be consid- shall be removed and condemned. ered extensively infested if in addition (g) As used in this section, the term to finding lesions in at least two of the ‘‘thin’’ does not apply to a carcass usual inspection sites, namely the which is anemic or emaciated; and the heart, diaphragm and its pillars, mus- term ‘‘lesions’’ refers to lesions of case- cles of mastication, esophagus, tongue, ous lymphadenitis. and musculature exposed during normal dressing operations, they are found § 311.19 Icterus. in at least two of the sites exposed by Carcasses showing any degree of ic- (i) an incision made into each round ex- terus shall be condemned. Yellow fat posing the musculature in cross sec- conditions caused by nutritional fac- tion, and (ii) a transverse incision into tors or characteristic of certain breeds each forelimb commencing 2 or 3 of livestock and yellow fat sometimes inches above the point of the olecranon seen in sheep shall not be confused and extending to the humerus. with icterus. Such carcasses should be (2) Carcasses of cattle showing one or passed for human food, if otherwise more tapeworm lesions of cysticercus normal. bovis but not so extensive as indicated

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in paragraph (a)(1) of this section, as the parasites and the lesions caused by determined by a careful examination, them can be completely removed, the including examination of, but not lim- nonaffected portion of the carcass, ited to, the heart, diaphragm and its organ, or other part of the carcass may pillars, muscles of mastication, esoph- be passed for human food after the re- agus, tongue, and musculature exposed moval and condemnation of the af- during normal dressing operations, fected portions. If an organ or other may be passed for human food after re- part of a carcass shows numerous le- moval and condemnation of the lesions sions caused by parasites, or if the with surrounding tissues: Provided, character of the infestation is such That the carcasses, appropriately iden- that complete extirpation of the para- tified by retained tags, are held in cold storage under positive control of a sitic infestation or invasion renders USDA Food Inspector at a temperature the part in any way unfit for human not higher than 15 °F. continuously for food, the affected part shall be con- a period of not less than 10 days, or in demned. If parasites are found to be the case of boned meat derived from distributed in a carcass in such a man- such carcasses, the meat, when in ner or to be of such character that boxes, tierces, or other containers, ap- their removal and the removal of the propriately identified by retained tags, lesions caused by them is impracti- is held under positive control of a Pro- cable, no part of the carcass shall be gram Inspector at a temperature of not passed for human food. If the infesta- higher than 15 °F. continuously for a tion is excessive, the carcass shall be period of not less than 20 days. As an condemned. If the infestation is mod- alternative to retention in cold storage erate, the carcass may be passed for as provided in this subparagraph, such cooking, but in case such carcass is not carcasses and meat may be heated cooked as required by part 315 of this throughout to a temperature of at subchapter, it shall be condemned. ° least 140 F. under positive control of a (b) In the case of sheep carcasses af- Program Inspector. fected with tapeworm cysts (b) Edible viscera and offal shall be (Cysticercus ovis, so-called sheep mea- disposed of in the same manner as the sles, not transmissible to man), such rest of the carcass from which they carcasses may be passed for human were derived unless any lesion of cysticercus bovis is found in these by- food after the removal and condemna- products, in which case they shall be tion of the affected portions: Provided, condemned. however, That if, upon the final inspection of sheep carcasses retained on ac- [36 FR 4591, Mar. 10, 1971] count of measles, the total number of § 311.24 Hogs affected with tapeworm cysts found embedded in muscular tis- cysts. sue, or in immediate relation with muscular tissue, excluding the heart, Carcasses of hogs affected with tape- exceeds five, the entire carcass shall be worm cysts (Cysticercus cellulosae) may be passed for cooking, unless the condemned, or such carcass shall be infestation is excessive, in which case heated throughout to a temperature of ° the carcass shall be condemned. at least 140 F. After removal and condemnation of all affected portions. § 311.25 Parasites not transmissible to (c) Carcasses found infested with gid man; tapeworm cysts in sheep; bladder-worms (Coenurus cerebralis, hydatid cysts; flukes; gid bladder- Multiceps multiceps) may be passed for worms. human food after condemnation of the (a) In the disposal of carcasses, edible affected organ (brain or spinal cord). organs, and other parts of carcasses (d) Organs or other parts of carcasses showing evidence of infestation with infested with hydatid cysts parasites not transmissible to man, the (echinococus) shall be condemned. following general rules shall govern ex- (e) Livers infested with flukes or cept as otherwise provided in this section: If the lesions are localized in such fringed tapeworms shall be condemned. manner and are of such character that

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§ 311.26 Emaciation. tween the muscles; or (d) the tissue Carcasses of livestock too emaciated which later develops as the fat capsule to produce wholesome meat, and car- of the kidneys is edematous, dirty yel- casses which show a serous infiltration low, or grayish-red, tough, and of muscle tissues, or a serous or mu- intermixed with islands of fat. coid degeneration of the fatty tissue, § 311.29 Unborn and stillborn animals. shall be condemned. A gelatinous change of the fat of the heart and kid- All unborn and stillborn animals neys of well-nourished carcasses and shall be condemned and no hide or skin mere leanness shall not be classed as thereof shall be removed from the car- emaciation. cass within a room in which edible products are handled. [35 FR 15569, Oct. 3, 1970; 36 FR 11903, June 23, 1971] § 311.30 Livestock suffocated and hogs scalded alive. § 311.27 Injured animals slaughtered at unusual hours. All livestock which have been suffocated in any way and hogs which have When it is necessary for humane rea- entered the scalding vat alive shall be sons to slaughter an injured animal at condemned. night or on Sunday or a holiday when the inspector cannot be obtained, the § 311.31 Livers affected with carcass and all parts of all livestock carotenosis; livers designated as except for cattle shall be kept for in- ‘‘telangiectatic,’’ ‘‘sawdust,’’ or spection, with the head and all viscera ‘‘spotted.’’ except the stomach, bladder, and intes- (a) Livers affected with carotenosis tines held by the natural attachments. shall be condemned. If all parts are not so kept for inspec- (b) Cattle livers and calf livers show- tion, the carcass shall be condemned. ing the conditions sometimes des- If, on inspection of a carcass slaugh- ignated as ‘‘telangiectatic,’’ ‘‘saw- tered in the absence of an inspector, dust,’’ or ‘‘spotted’’ shall be disposed of any lesion or other evidence is found as follows: indicating that the animal was sick or (1) When any or all of the conditions diseased, or affected with any other are slight in the organ, the whole condition requiring condemnation of organ shall be passed for human food the animal on ante-mortem inspection, without restriction. or if there is lacking evidence of the (2) When any or all of the conditions condition which rendered emergency are more severe than slight and involve slaughter necessary, the carcass shall less than one-half of the organ, while be condemned. The parts and carcasses in the remainder of the organ the con- of cattle slaughtered in the absence of ditions are slight or nonexistent, the an inspector shall not be used for remainder shall be passed for human human food. food without restriction and the other [35 FR 15569, Oct. 3, 1970, as amended at 69 FR portion shall be condemned. 1874, Jan. 12, 2004] (3) When any or all of the conditions are more severe than slight and involve § 311.28 Carcasses of young calves, one-half or more of the organ, the pigs, kids, lambs, and foals. whole organ shall be condemned. Carcasses of young calves, pigs, kids, (4) The divisions of an organ into two lambs, and foals are unwholesome and parts as contemplated in this para- shall be condemned if (a) the meat has graph for disposition, shall be accom- the appearance of being water-soaked, plished by one cut through the organ. is loose, flabby, tears easily, and can be This, of course, does not prohibit inci- perforated with the fingers; or (b) its sions which are necessary for inspec- color is grayish-red; or (c) good mus- tion. cular development as a whole is lack- (c) ‘‘Telangiectatic,’’ ‘‘sawdust,’’ or ing, especially noticeable on the upper ‘‘spotted’’ livers and parts of livers shank of the leg, where small amounts which are condemned for human food of serous infiltrates or small edema- may be shipped from an official estab- tous patches are sometimes present be- lishment for purposes other than

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human food in accordance with § 314.10 (c) If the lesions are slight or of such of this subchapter. character as to be insignificant from a standpoint of wholesomeness, the car- § 311.32 Vesicular diseases. cass or parts may be passed for use in (a) Any carcass affected with vesic- the manufacture of comminuted ular disease shall be condemned if the cooked product, after removal and con- condition is acute and if the extent of demnation of the visibly affected por- the condition is such that it affects the tions. entire carcass or there is evidence of absorption or secondary change. § 311.36 Coccidioidal granuloma. (b) Any carcass affected with vesic- (a) Carcasses which are affected with ular disease to a lesser extent than as generalized coccidioidal granuloma or described in paragraph (a) of this sec- which show systemic changes because tion may be passed for human food of such disease shall be condemned. after removal and condemnation of the (b) Carcasses affected with localized affected parts, if the carcass is other- lesions of this disease may be passed wise healthy. for human food after the affected parts § 311.33 Listeriosis. are removed and condemned. Carcasses of livestock identified as § 311.37 Odors, foreign and urine. U.S. Suspects because of a history of listeriosis shall be passed for human (a) Carcasses which give off a pro- food after condemnation of the head if nounced odor of medicinal, chemical, the carcass is otherwise normal. or other foreign substance shall be condemned. § 311.34 Anemia. (b) Carcasses which give off a pro- Carcasses of livestock too anemic to nounced urine odor shall be con- produce wholesome meat shall be condemned. demned. (c) Carcasses, organs, or parts affected by odor to a lesser degree than § 311.35 Muscular inflammation, de- as described in paragraphs (a) and (b) of generation, or infiltration. this section and in which the odor can (a) If muscular lesions are found to be removed by trimming or chilling be distributed in such a manner or to may be passed for human food, after re- be of such character that removal is moval of affected parts or dissipation impractical, the carcass shall be con- of the condition. demned. (b) If muscular lesions are found to § 311.38 Meat and meat byproducts be distributed in such a manner or to from livestock which have been ex- be of such character that removal is posed to radiation. practical, the following rules shall gov- Meat and meat byproducts from live- ern the disposal of the carcasses, edible stock which have been administered ra- organs, and other parts of carcasses dioactive material shall be condemned showing such muscular lesions. If the unless the use of the radiation was in lesions are localized in such a manner conformity with a regulation or exemp- and are of such a character that the af- tion in effect pursuant to section 409 of fected tissues can be removed, the non- the Federal Food, Drug, and Cosmetic affected parts of the carcass may be Act. passed for human food after the removal and condemnation of the af- § 311.39 Biological residues. fected portion. If a part of the carcass shows numerous lesions, or if the char- Carcasses, organs, or other parts of acter of the lesion is such that com- carcasses of livestock shall be con- plete extirpation is difficult and uncer- demned if it is determined that they tainly accomplished, or if the lesion are adulterated because of the presence renders the part in any way unfit for of any biological residues. human food, the part shall be condemned.

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PART 312—OFFICIAL MARKS, DEVICES AND CERTIFICATES

Sec. 312.1 General. 312.2 Official marks and devices to identify inspected and passed products of cattle, sheep, swine, or goats. 312.3 Official marks and devices to identify For application to sheep carcasses, inspected and passed equine products. the loins and ribs of pork, beef tails, 312.4 Official ante-mortem inspection and the smaller varieties of sausage marks and devices. and meat food products in animal cas- 312.5 Official seals for transportation of products. ings. 312.6 Official marks and devices in connection with post-mortem inspection and identification of adulterated products and insanitary equipment and facilities. 312.7 [Reserved] 312.8 Official export inspection marks, devices, and certificates. 312.9 Official detention marks and devices. 312.10 Official mark for maintaining the identity and integrity of samples.

AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, 2.55. For application to calf and goat car- SOURCE: 35 FR 15573, Oct. 3, 1970, unless otherwise noted. casses and on the larger varieties of sausage and meat food products in ani- § 312.1 General. mal casings. The marks, devices, and certificates prescribed or referenced in this part shall be official marks, devices, and certificates for purposes of the Act, and shall be used in accordance with the provisions of this part and the regulations cited therein.

§ 312.2 Official marks and devices to identify inspected and passed products of cattle, sheep, swine, or goats. (a) The official inspection legend required by part 316 of this subchapter to be applied to inspected and passed carcasses and parts of carcasses of cattle, sheep, swine and goats, meat food prod- For application to beef and hog car- ucts in animal casings, and other prod- casses primal parts and cuts therefrom, ucts as approved by the Administrator, beef livers, beef tongues, beef hearts, shall be in the appropriate form as and smoked meats not in casings. hereinafter specified: 1

1 The number ‘‘38’’ is given as an example cial establishment where the product is pre- only. The establishment number of the offi- pared shall be used in lieu thereof.

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ings, and other articles with the approval of the Administrator. (c) Any brand, stamp, label, or other device approved by the Administrator and bearing any official mark prescribed in paragraphs (a) or (b) of this section shall be an official device for purposes of the Act. [35 FR 15573, Oct. 3, 1970; 36 FR 12002, June 24, 1971]

§ 312.3 Official marks and devices to identify inspected and passed equine products. (a) The official inspection legend required by § 316.12 or § 317.2 of this subchapter to identify inspected and passed horse carcasses and parts of car- For application to burlap, muslin, casses, or horse meat food products cheesecloth, heavy paper, or other ac- shall be in the appropriate form as ceptable material that encloses car- hereinafter specified: 1 casses or parts of carcasses. (b)(1) The official inspection legend required by part 317 of this subchapter to be shown on all labels for inspected and passed products of cattle, sheep, swine, and goats shall be in the following form 1 except that it need not be of the size illustrated, provided that it is a sufficient size and of such color as to be conspicuously displayed and readily legible and the same proportions of letter size and boldness are maintained as illustrated:

(2) This official mark shall be applied by mechanical means and shall not be applied by a hand stamp. (3) The official inspection legend described in paragraph (b)(1) of this section may also be used for purposes of part 316 of this subchapter on shipping containers, band labels, artificial cas-

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(b) The official inspection legend re- (c) Any brand, stamp, label, or other quired by § 316.12 or § 317.2 of this sub- device approved by the Administrator chapter to identify inspected and and bearing any official mark pre- passed mule and other (nonhorse) scribed in paragraphs (a) or (b) of this equine carcasses and parts of carcasses, section shall be an official device for or equine meat food products shall be purposes of the Act. in whichever of the following form, is appropriate: 1 § 312.4 Official ante-mortem inspection marks and devices. The official marks and devices used in connection with ante-mortem inspection are those prescribed in § 309.18 of this subchapter.

§ 312.5 Official seals for transportation of products. The official mark for use in sealing railroad cars or other means of conveyance as prescribed in part 325 of this subchapter shall be the inscription and a serial number as hereinafter shown 2 and any seal approved by the Adminis- trator for applying such mark shall be an official device for purposes of the Act. This seal shall be attached to the means of conveyance only by a Pro- gram employee and he shall also affix thereto a ‘‘Warning Tag’’ (Form MP– 408–3).

[35 FR 15573, Oct. 3, 1970, as amended at 39 FR 36000, Oct. 7, 1974; 51 FR 37707, Oct. 24, 1986]

1 The number ‘‘38’’ is given as an example 2 The number ‘‘2135202’’ is given as an ex- only. The establishment number of the offi- ample only. The serial number of the specific cial establishment where the product is pre- seal will be shown in lieu thereof. pared shall be used in lieu thereof.

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§ 312.6 Official marks and devices in paragraph (a) of this section, shall be connection with post-mortem in- official devices for purposes of the Act. spection and identification of adulterated products and insanitary [35 FR 15573, Oct. 3, 1970, as amended at 38 FR 29214, Oct. 23, 1973; 39 FR 36000; Oct. 7, 1974; 43 equipment and facilities. FR 29268, July 7, 1978; 64 FR 36415, Oct. 20, (a) The official marks required by 1999; 65 FR 2284, Jan. 14, 2000] parts 310 and 416 of this chapter for use in post-mortem inspection and identi- § 312.7 [Reserved] fication of adulterated products and in- § 312.8 Official export inspection sanitary equipment and facilities are: marks, devices, and certificates. (1) The tag (Form MP–427) which is (a) The official export meat inspec- used to retain carcasses and parts of tion mark required by part 322 of this carcasses in the slaughter department; subchapter shall be in the following it is black and white, and bears the leg- form as hereinafter specified: 1 end ‘‘U.S. Retained.’’ (2) The ‘‘U.S. Retained’’ mark which is applied to products and articles as prescribed in part 310 of this subchapter by means of a paper tag (Form MP–35) bearing the legend ‘‘U.S. Re- tained.’’ (3) The ‘‘U.S. Rejected’’ mark which is used to identify insanitary buildings, rooms, or equipment as prescribed in part 416, section 6, of this chapter and is applied by means of a paper tag (Form MP–35) bearing the legend ‘‘U.S. Rejected.’’ (4) The ‘‘U.S. Passed for Cooking’’ Any rubber stamp approved by the Ad- mark is applied on products passed for ministrator, in the manner provided cooking as prescribed in part 310 of this for in part 317 of this subchapter, and subchapter by means of a brand and is bearing the official mark prescribed in in the following form: this paragraph shall be an official device for the purposes of the Act. (b) The official export certificate required by part 322 of this subchapter is a paper certificate form for signature by a Program employee, bearing a letterhead and the seal of the United States Department of Agriculture, (5) The ‘‘U.S. Inspected and Con- with a certification that meat or meat demned’’ mark shall be applied to prod- food products described on the form is ucts condemned as prescribed in part from animals that received ante- 310 by means of a brand and is in the mortem and post-mortem inspection following form: and were found sound and healthy and that it has been inspected and passed as provided by law and the regulations of the Department of Agriculture and is sound and wholesome. The certificate also bears a serial number such as ‘‘No. 184432.’’ [35 FR 15573, Oct. 3, 1970, as amended at 42 FR (b) The ‘‘U.S. Retained’’ and ‘‘U.S. 11825, Mar. 1, 1977; 47 FR 29823, July 9, 1982] Rejected’’ tags, and all other brands, stamps, labels, and other devices ap- 1 The number ‘‘529893’’ is given as an exam- proved by the Administrator and bear- ple only. The number of the official export ing any official mark prescribed in certificate will be shown in lieu thereof.

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§ 312.9 Official detention marks and AUTHORITY: 7 U.S.C. 1901–1906; 21 U.S.C. 601– devices. 695; 7 CFR 2.17, 2.55. The official mark for articles and SOURCE: 44 FR 68813, Nov. 30, 1979, unless livestock detained under part 329 of otherwise noted. this subchapter shall be the designation ‘‘U.S. Detained’’ and the official § 313.1 Livestock pens, driveways and ramps. device for applying such mark shall be the official ‘‘U.S. Detained’’ tag (FSIS (a) Livestock pens, driveways and Form 8400–2) as prescribed in § 329.2 of ramps shall be maintained in good re- this subchapter. pair. They shall be free from sharp or protruding objects which may, in the [55 FR 47842, Nov. 16, 1990] opinion of the inspector, cause injury or pain to the animals. Loose boards, § 312.10 Official mark for maintaining the identity and integrity of sam- splintered or broken planking, and un- ples. necessary openings where the head, feet, or legs of an animal may be in- The official mark for use in sealing jured shall be repaired. containers of samples submitted under (b) Floors of livestock pens, ramps, any requirements in this subchapter and driveways shall be constructed and and section 202 of the Federal Meat In- maintained so as to provide good foot- spection Act shall bear the designation ing for livestock. Slip resistant or waf- ‘‘Sample Seal’’ accompanied by the of- fled floor surfaces, cleated ramps and ficial USDA logo as shown below. Any the use of sand, as appropriate, during seal approved by the Administrator for winter months are examples of accept- applying such mark shall be deemed an able construction and maintenance. official device for purposes of the Act. (c) U.S. Suspects (as defined in Such device shall be supplied to inspec- § 301.2(xxx)) and dying, diseased, and tors, compliance officers, and other disabled livestock (as defined in designated Agency officials by the § 301.2(y)) shall be provided with a cov- United States Department of Agri- ered pen sufficient, in the opinion of culture. the inspector, to protect them from the adverse climatic conditions of the lo- cale while awaiting disposition by the inspector. (d) Livestock pens and driveways shall be so arranged that sharp corners and direction reversal of driven animals are minimized. [44 FR 68813, Nov. 30, 1979, as amended at 53 FR 49848, Dec. 12, 1988]

[52 FR 41958, Nov. 2, 1987] § 313.2 Handling of livestock. (a) Driving of livestock from the un- PART 313—HUMANE SLAUGHTER loading ramps to the holding pens and OF LIVESTOCK from the holding pens to the stunning area shall be done with a minimum of Sec. excitement and discomfort to the ani- 313.1 Livestock pens, driveways and ramps. mals. Livestock shall not be forced to 313.2 Handling of livestock. move faster than a normal walking 313.5 Chemical; carbon dioxide speed. 313.15 Mechanical; captive bolt. (b) Electric prods, canvas slappers, or 313.16 Mechanical; gunshot. other implements employed to drive 313.30 Electrical; stunning or slaughtering animals shall be used as little as pos- with electric current. sible in order to minimize excitement 313.50 Tagging of equipment, alleyways, pens or compartments to prevent inhu- and injury. Any use of such imple- mane slaughter or handling in connec- ments which, in the opinion of the in- tion with slaughter. spector, is excessive, is prohibited. 313.90 [Reserved] Electrical prods attached to AC house

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current shall be reduced by a trans- (2) The driving or conveying of the former to the lowest effective voltage animals to the carbon dioxide chamber not to exceed 50 volts AC. shall be done with a minimum of ex- (c) Pipes, sharp or pointed objects, citement and discomfort to the ani- and other items which, in the opinion mals. Delivery of calm animals to the of the inspector, would cause injury or anesthesia chamber is essential since unnecessary pain to the animal shall the induction, or early phase, of anes- not be used to drive livestock. thesia is less violent with docile ani- (d) Disabled livestock and other animals. Among other things this requires mals unable to move. that, in driving animals to the anes- (1) Disabled animals and other ani- thesia chamber, electrical equipment mals unable to move shall be separated be used as little as possible and with from normal ambulatory animals and the lowest effective voltage. placed in the covered pen provided for (3) On emerging from the carbon di- in § 313.1(c). oxide tunnel, the animals shall be in a (2) The dragging of disabled animals state of surgical anesthesia and shall and other animals unable to move, remain in this condition throughout while conscious, is prohibited. Stunned shackling, sticking, and bleeding, ex- animals may, however, be dragged. cept for swine in which death has been (3) Disabled animals and other ani- induced by the administration of car- mals unable to move may be moved, bon dioxide. Asphyxia or death from while conscious, on equipment suitable any cause shall not be produced in ani- for such purposes; e.g., stone boats. mals before bleeding, except for swine in which death has been induced by the (e) Animals shall have access to administration of carbon dioxide. water in all holding pens and, if held (b) Facilities and procedures—(1) Gen- longer than 24 hours, access to feed. eral requirements for gas chambers and There shall be sufficient room in the auxiliary equipment; operator. (i) The holding pen for animals held overnight carbon dioxide gas shall be adminis- to lie down. tered in a tunnel which is designed to (f) Stunning methods approved in permit the effective exposure of the § 313.30 shall be effectively applied to animal. Two types of tunnels, based on animals prior to their being shackled, the same principle, are in common use hoisted, thrown, cast, or cut. for carbon dioxide anesthesia. They are the ‘‘U’’ type tunnel and the ‘‘Straight § 313.5 Chemical; carbon dioxide. Line’’ type tunnel, and are based on The slaughtering of sheep, calves and the principle that carbon dioxide gas swine with the use of carbon dioxide has a higher specific gravity than air. gas and the handling in connection The tunnels are open at both ends for therewith, in compliance with the pro- entry and exit of animals and have a visions contained in this section, are depressed central section. Anes- hereby designated and approved as hu- thetizing, or, in the case of swine, mane methods of slaughtering and han- death-inducing, carbon dioxide con- dling of such animals under the Act. centrations are maintained in the cen- (a) Administration of gas, required ef- tral sections of the tunnels. Effective fect; handling. (1) The carbon dioxide anaesthetization is produced in these gas shall be administered in a chamber central sections. Animals are driven in accordance with this section so as to from holding pens through pathways produce surgical anesthesia in the ani- constructed of large-diameter pipe or mals before they are shackled, hoisted, smooth metal and onto continuous thrown, cast, or cut. The animals shall conveyor devices that move the ani- be exposed to the carbon dioxide gas in mals through the tunnels. The animals a way that will accomplish the anes- are either compartmentalized on the thesia quickly and calmly, with a min- conveyors by mechanical impellers imum of excitement and discomfort to synchronized with the conveyor or the animals. In swine, carbon dioxide they are otherwise prevented from may be administered to induce death in crowding. While impellers are used to the animals before they are shackled, compartmentalize the animals, me- hoisted, thrown, cast, or cut. chanically or manually operated gates

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are used to move the animals onto the ide or from a controlled liquid source. conveyors. Surgically anaesthetized In either case the carbon dioxide shall animals, or killed swine, are moved out be supplied at a rate sufficient to anes- of the tunnels by the same continuous thetize adequately and uniformly the conveyors that moved them into and number of animals passing through the through the carbon dioxide gas. chamber. Sampling of gas for analysis (ii) Flow of animals into and through shall be made from a representative the carbon dioxide chamber is depend- place or places within the chamber and ent on one operator. The operation or on a continuing basis. Gas concentra- stoppage of the conveyor is entirely de- tions and exposure time shall be pendent upon this operator. It is nec- graphically recorded throughout each essary that he be skilled, attentive, day’s operation. Neither carbon dioxide and aware of his responsibility. Over- nor atmospheric air used in the anes- dosages and death of animals can be thesia chambers shall contain noxious brought about by carelessness of this or irritating gases. Each day before individual. equipment is used for anesthetizing (2) Special requirements for gas chamber animals, proper care shall be taken to and auxiliary equipment. The ability of mix adequately the gas and air within anesthetizing equipment to perform the chamber. All gas producing and with maximum efficiency is dependent control equipment shall be maintained on its proper design and efficient mein good repair and all indicators, in- chanical operation. Pathways, com- struments, and measuring devices must partments, gas chambers, and all other be available for inspection by Program equipment used must be designed to ac- inspectors during anesthetizing oper- commodate properly the species of ani- ations and at other times. An exhaust mals being anesthetized. They shall be system must be provided so that, in free from pain-producing restraining case of equipment failure, non-uniform devices. Injury of animals must be pre- carbon dioxide concentrations in the vented by the elimination of sharp pro- gas tunnel or contamination of the am- jections or exposed wheels or gears. bient air of the establishment will be There shall be no unnecessary holes, prevented. spaces or openings where feet or legs of [44 FR 68813, Nov. 30, 1979, as amended at 59 animals may be injured. Impellers or FR 21640, Apr. 26, 1994] other devices designed to mechanically move or drive animals or otherwise § 313.15 Mechanical; captive bolt. keep them in motion or compartmen- The slaughtering of sheep, swine, talized shall be constructed of flexible goats, calves, cattle, horses, mules, and or well padded rigid material. Power other equines by using captive bolt activated gates designed for constant stunners and the handling in connec- flow of animals to anesthetizing equip- tion therewith, in compliance with the ment shall be so fabricated that they provisions contained in this section, will not cause injury. All equipment in- are hereby designated and approved as volved in anesthetizing animals shall humane methods of slaughtering and be maintained in good repair. handling of such animals under the (3) Gas. Maintenance of a uniform Act. carbon dioxide concentration and dis- (a) Application of stunners, required ef- tribution in the anesthesia chamber is fect; handling. (1) The captive bolt stun- a vital aspect of producing surgical an- ners shall be applied to the livestock in esthesia. This may be assured by rea- accordance with this section so as to sonably accurate instruments which produce immediate unconsciousness in sample and analyze carbon dioxide gas the animals before they are shackled, concentration within the chamber hoisted, thrown, cast, or cut. The ani- throughout anesthetizing operations. mals shall be stunned in such a manner Gas concentration shall be maintained that they will be rendered unconscious uniform so that the degree of anes- with a minimum of excitement and dis- thesia in exposed animals will be con- comfort. stant. Carbon dioxide gas supplied to (2) The driving of the animals to the anesthesia chambers may be from con- stunning area shall be done with a min- trolled reduction of solid carbon diox- imum of excitement and discomfort to

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the animals. Delivery of calm animals ers, it is desirable that any stunning to the stunning areas is essential since device be equipped with safety features accurate placement of stunning equip- to prevent injuries from accidental dis- ment is difficult on nervous or injured charge. Stunning instruments must be animals. Among other things, this re- maintained in good repair. quires that, in driving animals to the (iii) The stunning area shall be so de- stunning areas, electrical equipment be signed and constructed as to limit the used as little as possible and with the free movements of animals sufficiently lowest effective voltage. to allow the operator to locate the (3) Immediately after the stunning stunning blow with a high degree of ac- blow is delivered the animals shall be curacy. All chutes, alleys, gates and rein a state of complete unconsciousness straining mechanisms between and in- and remain in this condition throughout shackling, sticking and bleeding. cluding holding pens and stunning (b) Facilities and procedures—(1) Gen- areas shall be free from pain-producing eral requirements for stunning facilities; features such as exposed bolt ends, operator. (i) Acceptable captive bolt loose boards, splintered or broken stunning instruments may be either planking, and protruding sharp metal skull penetrating or nonpenetrating. of any kind. There shall be no unneces- The latter type is also described as a sary holes or other openings where feet concussion or mushroom type stunner. or legs of animals may be injured. Penetrating instruments on detonation Overhead drop gates shall be suitably deliver bolts of varying diameters and covered on the bottom edge to prevent lengths through the skull and into the injury on contact with animals. Rough- brain. Unconsciousness is produced im- ened or cleated cement shall be used as mediately by physical brain destruc- flooring in chutes leading to stunning tion and a combination of changes in areas to reduce falls of animals. intracranial pressure and acceleration Chutes, alleys, and stunning areas concussion. Nonpenetrating or mush- shall be so designed that they will com- room stunners on detonation deliver a fortably accommodate the kinds of ani- bolt with a flattened circular head mals to be stunned. against the external surface of the ani- (iv) The stunning operation is an ex- mal’s head over the brain. Diameter of acting procedure and requires a well- the striking surface of the stunner may trained and experienced operator. He vary as conditions require. Uncon- must be able to accurately place the sciousness is produced immediately by a combination of acceleration concus- stunning instrument to produce imme- sion and changes in intracranial pres- diate unconsciousness. He must use the sures. A combination instrument uti- correct detonating charge with regard lizing both penetrating and nonpene- to kind, breed, size, age, and sex of the trating principles is acceptable. Ener- animal to produce the desired results. gizing of instruments may be accom- (2) Special requirements and prohibi- plished by detonation of measured tions. (i) Choice of instrument and force charges of gunpowder or accurately required to produce immediate uncon- controlled compressed air. Captive sciousness varies, depending on kind, bolts shall be of such size and design breed, size, age, and sex of the animal. that, when properly positioned and ac- Young swine, lambs, and calves usually tivated, immediate unconsciousness is require less stunning force than ma- produced. ture animals of the same kind. Bulls, (ii) To assure uniform unconscious- rams, and boars usually require skull ness with every blow, compressed air penetration to produce immediate un- devices must be equipped to deliver the consciousness. Charges suitable for necessary constant air pressure and smaller kinds of livestock such as must have accurate, constantly oper- swine or for young animals are not ac- ating air pressure gauges. Gauges must ceptably interchanged for use on larger be easily read and conveniently located kinds or older livestock, respectively. for use by the stunning operator and the inspector. For purposes of pro- (ii) Captive bolt stunners that delib- tecting employees, inspectors, and oth- erately inject compressed air into the

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cranium at the end of the penetration (ii) To assure uniform unconscious- cycle shall not be used to stun cattle. ness of the animal with every discharge where small-bore firearms are em- [44 FR 68813, Nov. 30, 1979, as amended at 69 FR 1891, Jan. 12, 2004] ployed, it is necessary to use one of the following type projectiles: Hollow § 313.16 Mechanical; gunshot. pointed bullets; frangible iron plastic composition bullets; or powdered iron The slaughtering of cattle, calves, missiles. When powdered iron missiles sheep, swine, goats, horses, mules, and are used, the firearms shall be in close other equines by shooting with fire- proximity with the skull of the animal arms and the handling in connection when fired. Firearms must be main- therewith, in compliance with the pro- tained in good repair. For purposes of visions contained in this section, are protecting employees, inspectors and hereby designated and approved as hu- others, it is desirable that all firearms mane methods of slaughtering and han- be equipped with safety devices to pre- dling of such animals under the Act. vent injuries from accidental dis- (a) Utilization of firearms, required ef- charge. Aiming and discharging of fire- fect; handling. (1) The firearms shall be arms should be directed away from op- employed in the delivery of a bullet or erating areas. projectile into the animal in accord- (iii) The provisions contained in ance with this section so as to produce § 313.15(b)(1)(iii) with respect to the immediate unconsciousness in the ani- stunning area also apply to the shoot- mal by a single shot before it is shackled, hoisted, thrown, cast, or cut. The ing area. animal shall be shot in such a manner (iv) The shooting operation is an ex- that they will be rendered unconscious acting procedure and requires a well- with a minimum of excitement and dis- trained and experienced operator. He comfort. must be able to accurately direct the (2) The driving of the animals to the projectile to produce immediate uncon- shooting areas shall be done with a sciousness. He must use the correct minimum of excitement and discom- caliber firearm, powder charge and fort to the animals. Delivery of calm type of ammunition to produce the de- animals to the shooting area is essen- sired results. tial since accurate placement of the (2) Special requirements. Choice of fire- bullet is difficult in case of nervous or arms and ammunition with respect to injured animals. Among other things, caliber and choice of powder charge re- this requires that, in driving animals quired to produce immediate uncon- to the shooting areas, electrical equip- sciousness of the animal may vary de- ment be used as little as possible and pending on age and sex of the animal. with the lowest effective voltage. In the case of bulls, rams, and boars, (3) Immediately after the firearm is small bore firearms may be used pro- discharged and the projectile is deliv- vided they are able to produce imme- ered, the animal shall be in a state of diate unconsciousness of the animals. complete unconsciousness and remain Small bore firearms are usually effec- in this condition throughout shackling, tive for stunning other cattle, sheep, sticking and bleeding. swine, and goats, and calves, horses, (b) Facilities and procedure—(1) Gen- and mules. eral requirements for shooting facilities; operator. (i) On discharge, acceptable § 313.30 Electrical; stunning or slaughtering with electric current. firearms dispatch free projectiles or bullets of varying sizes and diameters The slaughtering of swine, sheep, through the skull and into the brain. calves, cattle, and goats with the use of Unconsciousness is produced imme- electric current and the handling in diately by a combination of physical connection therewith, in compliance brain destruction and changes in with the provisions contained in this intracranial pressure. Caliber of fire- section, are hereby designated and ap- arms shall be such that when properly proved as humane methods of slaugh- aimed and discharged, the projectile tering and handling of such animals produces immediate unconsciousness. under the Act.

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(a) Administration of electric current, in motion or compartmentalized shall required effect; handling. (1) The electric be constructed of flexible or padded current shall be administered so as to material. Power activated gates de- produce, at a minimum, surgical anes- signed for constant flow of animals thesia, i.e., a state where the animal shall be so fabricated that they will feels no painful sensation. The animals not cause injury. All equipment used to shall be either stunned or killed before apply and control the electrical cur- they are shackled, hoisted, thrown, rent shall be maintained in good re- cast, or cut. They shall be exposed to pair, and all indicators, instruments, the electric current in a way that will and measuring devices shall be avail- accomplish the desired result quickly able for inspection by Program inspec- and effectively, with a minimum of ex- tors during the operation and at other citement and discomfort. times. (2) The driving or conveying of the (3) Electric current. Each animal shall animals to the place of application of be given a sufficient application of electric current shall be done with a electric current to ensure surgical an- minimum of excitement and discom- esthesia throughout the bleeding oper- fort to the animals. Delivery of calm ation. Suitable timing, voltage and animals to the place of application is current control devices shall be used to essential to ensure rapid and effective ensure that each animal receives the insensibility. Among other things, this necessary electrical charge to produce requires that, in driving animals to the immediate unconsciousness. The cur- place of application, electrical equip- rent shall be applied so as to avoid the ment be used as little as possible and production of hemorrhages or other tis- with the lowest effective voltage. sue changes which could interfere with (3) The quality and location of the inspection procedures. electrical shock shall be such as to produce immediate insensibility to [44 FR 68813, Nov. 30, 1979, as amended at 50 pain in the exposed animal. FR 25202, June 18, 1985] (4) The stunned animal shall remain in a state of surgical anesthesia § 313.50 Tagging of equipment, alley- through shackling, sticking, and bleed- ways, pens, or compartments to prevent inhumane slaughter or han- ing. dling in connection with slaughter. (b) Facilities and procedures; operator— (1) General requirements for operator. It When an inspector observes an inci- is necessary that the operator of elec- dent of inhumane slaughter or han- tric current application equipment be dling in connection with slaughter, he/ skilled, attentive, and aware of his or she shall inform the establishment op- her responsibility. erator of the incident and request that (2) Special requirements for electric cur- the operator take the necessary steps rent application equipment. The ability to prevent a recurrence. If the estab- of electric current equipment to per- lishment operator fails to take such ac- form with maximum efficiency is de- tion or fails to promptly provide the pendent on its proper design and effi- inspector with satisfactory assurances cient mechanical operation. Pathways, that such action will be taken, the in- compartments, current applicators, spector shall follow the procedures and all other equipment used must be specified in paragraph (a), (b), or (c) of designed to properly accommodate the this section, as appropriate. species of animals being anesthetized. (a) If the cause of inhumane treat- Animals shall be free from pain-pro- ment is the result of facility defi- ducing restraining devices. Injury of ciencies, disrepair, or equipment animals must be prevented by the breakdown, the inspector shall attach elimination of sharp projections or ex- a ‘‘U.S. Rejected’’ tag thereto. No posed wheels or gears. There shall be equipment, alleyway, pen or compart- no unnecessary holes, spaces or open- ment so tagged shall be used until ings where feet or legs of animals may made acceptable to the inspector. The be injured. Impellers or other devices tag shall not be removed by anyone designed to mechanically move or other than an inspector. All livestock drive animals or otherwise keep them slaughtered prior to such tagging may

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be dressed, processed, or prepared 314.9 Specimens for educational, research, under inspection. and other nonfood purposes; permits for, (b) If the cause of inhumane treat- required. ment is the result of establishment em- 314.10 Livers condemned because of parasitic infestation and for other causes; ployee actions in the handling or mov- conditions for disposal for purposes other ing of livestock, the inspector shall at- than human food. tach a ‘‘U.S. Rejected’’ tag to the al- 314.11 Handling of certain condemned prod- leyways leading to the stunning area. ucts for purposes other than human food. After the tagging of the alleyway, no more livestock shall be moved to the AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, 2.55. stunning area until the inspector receives satisfactory assurances from the SOURCE: 35 FR 15575, Oct. 3, 1970, unless establishment operator that there will otherwise noted. not be a recurrence. The tag shall not be removed by anyone other than an § 314.1 Disposition of condemned prod- inspector. All livestock slaughtered ucts at official establishments having tanking facilities; sealing of prior to the tagging may be dressed, tanks. processed, or prepared under inspection. (a) Carcasses, parts of carcasses, and (c) If the cause of inhumane treat- other products condemned at official ment is the result of improper stun- establishments having facilities for ning, the inspector shall attach a ‘‘U.S. tanking shall, except as provided in Rejected’’ tag to the stunning area. paragraph (c) of this section or else- Stunning procedures shall not be re- where in this part, be disposed of by sumed until the inspector receives sat- tanking as follows: isfactory assurances from the estab- (1) The lower opening of the tank lishment operator that there will not shall first be sealed securely by a Pro- be a recurrence. The tag shall not be gram employee, except when perma- removed by anyone other than an in- nently connected with a blow line; then spector. All livestock slaughtered prior the condemned products shall be placed to such tagging may be dressed, proc- in the tank in his presence, after which essed, or prepared under inspection. the upper opening shall also be sealed securely by such employee, who shall § 313.90 [Reserved] then see that the contents of the tank are subjected to sufficient heating for PART 314—HANDLING AND DIS- sufficient time to effectively destroy POSAL OF CONDEMNED OR the contents for human food purposes. (2) The use of equipment such as OTHER INEDIBLE PRODUCTS AT crushers or hashers for pretanking OFFICIAL ESTABLISHMENTS preparation of condemned products in the inedible products department has Sec. been found to give inedible character 314.1 Disposition of condemned products at and appearance to the material. Ac- official establishments having tanking facilities; sealing of tanks. cordingly, if condemned products are 314.2 Tanking and other facilities for ined- so crushed or hashed, conveying sys- ible products to be separate from edible tems, rendering tanks, and other equip- product facilities. ment used in the further handling of 314.3 Disposition of condemned products at crushed or hashed material need not be official establishments having no locked or sealed during the tanking op- tanking facilities. erations. If the rendering tanks or 314.4 Suppression of odors in preparing ined- other equipment contain condemned ible products. material not so crushed or hashed, the 314.5 Inedible rendered fats prepared at offi- equipment shall be sealed as prescribed cial establishments. in paragraph (a)(1) of this section. If 314.6 Inedible fats from outside official establishments. the crushed or hashed material is not 314.7 Carcasses of livestock condemned on rendered in the establishment where ante-mortem inspection not to pass produced, it shall be denatured as pro- through edible product areas. vided for in § 314.3 before leaving such 314.8 Dead animal carcasses. establishment.

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(b) The seals of tanks shall be broken been dressed, the denaturant may be only by a Program employee and only applied by injection. The denaturant after the contents of the tanks have must be deposited in all portions of the been treated as provided in paragraph carcass or product to the extent nec- (a) of this section. The rendered fat de- essary to preclude its use for food pur- rived from condemned material shall poses. be held until a Program employee shall (b) All carcasses and parts con- have had an opportunity to determine demned on account of anthrax, as iden- whether it conforms with the require- tified in § 310.9(b) of this subchapter, at ments of this section. Samples shall be official establishments which are not taken by Program employees as often equipped with tanking facilities shall as is necessary to determine whether be disposed of by (1) complete inciner- the rendered fat is effectually dena- ation, or (2) by thorough denaturing tured. with crude carbolic acid, or cresylic (c) Carcasses of animals condemned disinfectant, and then disposed of in under § 309.3 of this subchapter may be accordance with the requirements of disposed of as provided in § 314.3, in lieu the particular State or municipal au- of tanking, with the approval of the in- thorities, who shall be notified imme- spector. diately by the area supervisor. § 314.2 Tanking and other facilities for inedible products to be separate § 314.4 Suppression of odors in pre- from edible product facilities. paring inedible products. All tanks and equipment used for Tanks, fertilizer driers, and other rendering, otherwise preparing, or stor- equipment used in the preparation of ing inedible products must be in rooms inedible product must be operated in a or compartments separate from those manner that will suppress odors inci- used for preparing or storing edible dent to such preparation which could products. There may be a connection adulterate edible product or create in- between rooms or compartments con- sanitary conditions. taining inedible products and those [64 FR 56416, Oct. 20, 1999] containing edible products as long as it does not cause the adulteration of edi- § 314.5 Inedible rendered fats pre- ble product or create insanitary condi- pared at official establishments. tions. Except as provided in § 325.11(b) of [64 FR 56416, Oct. 20, 1999] this subchapter, rendered animal fat derived from condemned or other ined- § 314.3 Disposition of condemned prod- ible materials at official establish- ucts at official establishments having no tanking facilities. ments shall be denatured to effectually distinguish it from an edible product, (a) Carcasses, parts of carcasses, and either with low grade offal during the other products condemned at an offi- rendering or by adding to, and mixing cial establishment which has no facili- thoroughly with, such fat, denaturing ties for tanking shall, except as pro- oil, No. 2 fuel oil, or brucine dissolved vided in paragraph (b) of this section or in a mixture of alcohol and pine oil or elsewhere in this part, be destroyed in oil of rosemary, and may be shipped in the presence of an inspector by inciner- commerce in accordance with § 325.11(c) ation, or denatured with crude carbolic of this subchapter. acid, or cresylic disinfectant, or a formula consisting of one part FD&C No. [35 FR 15575, Oct. 3, 1970, as amended at 53 FR 3 green coloring, 40 parts water, 40 24679, June 30, 1988] parts liquid detergent, and 40 parts oil of citronella or any other proprietary § 314.6 Inedible fats from outside offi- material approved by the Adminis- cial establishments. trator in specific cases. When such Except as provided in § 325.11(b) of product is to be denatured, it shall be this subchapter, inedible fats from out- freely slashed before the denaturing side the premises of any official estab- agent is applied, except that, in the lishment shall not be received into an case of dead animals that have not official establishment except into the

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tank room provided for inedible prod- arranges with and receives permission ucts, and then only when they have from the official establishment to ob- been denatured in accordance with tain the specimens. Permits shall be § 314.5 and are marked in accordance issued for a period not longer than 1 with § 316.15 of this subchapter, and year. The permit may be revoked by when their receipt into the tank room the inspector in charge if the speci- produces no insanitary condition on mens are not used as stated in the ap- the premises; nor shall such fats be re- plication, or if the collection or han- ceived in such volume as interferes dling of the specimens interferes with with prompt disposal of condemned or inspection or the maintenance of sani- other inedible material produced at the tary conditions in the establishment. establishment. When received, they (b) The specimens referred to in para- shall not enter any room or compart- graph (a) of this section shall be col- ment used for edible products. lected and handled only at such time [35 FR 15575, Oct. 3, 1970, as amended at 53 FR and place and in such manner as not to 24679, June 30, 1988] interfere with the inspection or to cause any objectionable condition and § 314.7 Carcasses of livestock con- shall be identified as inedible when demned on ante-mortem inspection they leave the establishment. not to pass through edible product areas. [35 FR 15575, Oct. 3, 1970, as amended at 38 FR Carcasses of livestock which have 18665, July 13, 1973; 39 FR 36000, Oct. 7, 1974] been condemned on ante-mortem inspection shall not be taken through § 314.10 Livers condemned because of parasitic infestation and for other rooms or compartments in which an causes; conditions for disposal for edible product is prepared, handled, or purposes other than human food. stored. (a) Livers condemned on account of § 314.8 Dead animal carcasses. hydatid cysts shall be disposed of by (a) With the exception of dead live- tanking pursuant to the provisions of stock which have died en route and are § 314.1 of this subchapter if condemned received with livestock for slaughter at at official establishments having facili- an official establishment, no dead ani- ties for tanking; otherwise they shall mal or part of the carcass of any live- be destroyed pursuant to the provisions stock that died otherwise than by of § 314.3 of this subchapter. slaughter may be brought on the prem- (b) Livers condemned because of ises of an official establishment unless parasites other than hydatid cysts; and advance permission therefore is ob- livers condemned because of tained from the circuit supervisor. telangiectasis, angioma, ‘‘sawdust’’ (b) Under no circumstances shall the condition, cirrhosis, carotenosis, or carcasses of any animal which has died other nonmalignant change, benign ab- otherwise than by slaughter, or any scesses, or contamination, when these part thereof, be brought into any room conditions are not associated with in- or compartment in which any edible fectious diseases in the carcasses, may product is prepared, handled, or stored. be shipped from an official establishment only for purposes other than § 314.9 Specimens for educational, re- human food, and only if all tissue af- search, and other nonfood pur- fected with abscesses is removed and poses; permits for, required. destroyed within the establishment, (a) Specimens of condemned or other and all livers are processed and dena- inedible materials, including embryos tured, with any agent prescribed in and specimens of animal parasites, § 325.13(a)(1) or (2) or (5), and in accord- may be released for educational, re- ance with § 325.13(a)(6) of this sub- search, or other nonfood purposes chapter. This provision for movement under permit issued by the inspector in from an official establishment is made charge: Provided, That the person desir- solely under the Federal Meat Inspec- ing such specimens makes a written tion Act and is not intended to relieve application to the inspector in charge or modify any other applicable require- for such permit on Form MP–403–10 and ments under any other law regarding

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the movement of such articles, for pur- 315.3 Disposal of products passed for cook- poses other than use as human food. ing if not handled according to this part. (c) Livers condemned because of con- AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, ditions described in paragraph (b) of 2.55. this section shall be in containers plainly marked ‘‘inedible’’. § 315.1 Carcasses and parts passed for [41 FR 23701, June 11, 1976] cooking; rendering into lard or tallow. § 314.11 Handling of certain con- Carcasses and parts passed for cook- demned products for purposes ing may be rendered into lard in ac- other than human food. cordance with § 319.702 of this sub- Condemned carcasses of animals af- chapter or rendered into tallow, pro- fected with one or more of the fol- vided such rendering is done in the following conditions may be shipped from lowing manner: an official establishment only for pur- (a) When closed rendering equipment poses other than human food and only is used, the lower opening, except when if permission therefor is obtained from permanently connected with a the circuit supervisor: Anasarca, Ocu- blowline, shall first be sealed securely lar Squamous Cell Carcinoma (after removal of neoplastic tissue), emacia- by a Program employee; then the car- tion, eosinophilic myositis, immatu- casses or parts shall be placed in such rity, nonseptic bruises and injuries, equipment in his presence, after which and sarcosporidiosis. This provision the upper opening shall be securely also applies to unborn calves and to sealed by such employee. When the products such as paunches and udders product passed for cooking in the tank when they have not been handled as re- does not consist of a carcass or whole quired under this subchapter for prod- primal part, the requirements for seal- ucts for human food purposes; pro- ing shall be at the discretion of the cir- vided, such articles have not been con- cuit supervisor. Such carcasses and demned for other pathological reasons. parts shall be cooked for a time suffi- Such permission will be granted only if cient to render them effectually into all parts to be so used will be promptly lard or tallow, provided all parts of the handled, freely slashed and adequately products are heated to a temperature identified as required by § 325.13(a)(2) of not lower than 170 °F. for a period of this subchapter. The slashing, identi- not less than 30 minutes. fication and packing of the product (b) At establishments not equipped shall be accomplished in an inedible with closed rendering equipment for product area under the supervision of rendering carcasses and parts passed an inspector. Facilities must be ade- for cooking into lard and tallow, such quate so that the carcasses or parts carcasses or parts may be rendered in saved under these provisions are not open kettles under the direct super- contaminated with pus, manure, septic, vision of a Program employee. Such or toxic materials, or similar sub- rendering shall be done during regular stances. The operation must not result hours of work and in compliance with in unsanitary conditions within the es- the requirements as to temperature tablishment. and time specified in paragraph (a) of [35 FR 15575, Oct. 3, 1970, as amended at 36 FR this section. 11639, June 17, 1971; 36 FR 11903, June 23, 1971] [35 FR 15577, Oct. 3, 1970, as amended at 43 FR PART 315—RENDERING OR OTHER 25420, June 13, 1978] DISPOSAL OF CARCASSES AND § 315.2 Carcasses and parts passed for PARTS PASSED FOR COOKING cooking; utilization for food purposes after cooking. Sec. Carcasses and parts passed for cook- 315.1 Carcasses and parts passed for cooking may be used for the preparation of ing; rendering into lard or tallow. 315.2 Carcasses and parts passed for cook- meat food products, provided all such ing; utilization for food purposes after carcasses or parts are heated to a tem- cooking. perature not lower than 170 °F. for a

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period of not less than 30 minutes ei- § 316.1 Authorization required to make ther before being used in or during the devices bearing official marks. preparation of the finished product. No brand manufacturer, printer or [37 FR 2661, Feb. 4, 1972] other person shall cast, print, lithograph, or otherwise make or cause to § 315.3 Disposal of products passed for be made any device containing any of- cooking if not handled according to ficial mark or simulation thereof with- this part. out prior written authority therefor Products passed for cooking if not from the Administrator as provided for handled and processed in accordance in part 317 of this subchapter. with the provisions of this part, shall be disposed of in accordance with § 314.1 § 316.2 Approval required for official marks. or § 314.3 of this subchapter. No device containing any official [35 FR 15577, Oct. 3, 1970. Redesignated at 37 mark shall be made or caused to be FR 2661, Feb. 4, 1972] made for use on any product until it has been approved by the Adminis- PART 316—MARKING PRODUCTS trator as provided for in part 317 of this AND THEIR CONTAINERS subchapter.

Sec. § 316.3 Use of official marks prohibited 316.1 Authorization required to make de- except under supervision of Pro- vices bearing official marks. gram employee; removal of official marks, when required. 316.2 Approval required for official marks. 316.3 Use of official marks prohibited except (a) No person shall affix or place, or under supervision of Program employee; cause to be affixed or placed, the offi- removal of official marks, when required. cial inspection legend or any other offi- 316.4 Marking devices; to be furnished by of- cial mark, or any abbreviation or sim- ficial establishments; control of. ulation of any official mark, to or on 316.5 Branding ink; to be furnished by offi- any product, or container thereof, ex- cial establishments; approval by Pro- cept under the supervision of a Pro- gram; color. gram employee, or as authorized by 316.6 Products not to be removed from official establishments unless marked in ac- part 317 of this subchapter in connec- cordance with the regulations. tion with the manufacture of con- 316.7 Marking devices not to be false or mis- tainers. leading; style and size of lettering; ap- (b) No person shall fill, or cause to be proval required. filled, in whole or in part, with any 316.8 Unmarked inspected products; moved product, any container bearing or in- between official establishments; moved tended to bear any official mark, or in commerce. any abbreviation or simulation of any 316.9 Products to be marked with official official mark, except under the super- marks. vision of a Program employee. 316.10 Marking of meat food products with official inspection legend and ingredient (c) Product bearing any official mark statement. shall not be canned, cooked, cured, 316.11 Special markings for certain meat smoked, salted, packed, rendered, or food products. otherwise prepared by any person for 316.12 Marking of equine carcasses and commercial purposes unless: parts thereof. (1) Such preparation is performed at 316.13 Marking of outside containers. an official establishment; or 316.14 Marking tank cars and tank trucks (2) Such preparation is conducted used in transportation of edible products. under State or other governmental in- 316.15 Marking outside containers of ined- spection and the prepared product is ible grease, etc. marked to show that fact; or 316.16 Custom prepared products to be (3) The official marks are removed, marked ‘‘Not for Sale.’’ defaced, or otherwise destroyed before AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, or during such preparation; or 2.55. (4) The preparation of the product SOURCE: 35 FR 15577, Oct. 3, 1970, unless consists solely of cutting up operations otherwise noted. at any establishment exempted from

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inspection under paragraph 301(c)(2) of not be considered an approved ink the Act or equal provisions of a law of within the meaning of this paragraph. a State or organized Territory or at (c) Green ink shall not be used to any establishment in an unorganized apply marks to carcasses of cattle, Territory exempted under paragraph sheep, swine, or goats or fresh meat 23(b) of the Act. cuts derived therefrom. (d) Except as provided in paragraphs § 316.4 Marking devices; to be fur- (b) and (c) of this section, branding ink nished by official establishments; control of. of any color, approved for the purpose by the Administrator in specific cases, (a) The operator of each official es- may be used to apply ink brands, bear- tablishment or official import inspec- ing official marks, to processed meat tion establishment shall furnish such cuts derived from cattle, sheep, swine, ink brands, burning brands, and any or goats. other device for marking products with (e) Only green ink approved for the official marks as the Administrator may determine is necessary for mark- purpose shall be used to apply ink ing products at such establishment. brands bearing official marks to car- The official inspection legend on such a casses and parts of carcasses and meat device shall be as prescribed in part 312 cuts derived from horses, mules, and of this subchapter. other equines. (b) All official devices for marking (f) Ink used must assure legibility products with the official inspection and permanence of the markings and legend, or other official inspection the color of ink shall provide accept- marks, including self-locking seals, able contrast with the color of the shall be used only under supervision of product to which it is applied. a Program employee, and, when not in [35 FR 15577, Oct. 3, 1970, as amended at 38 FR use for marking shall be kept locked in 9088, Apr. 10, 1973] properly equipped locks or compartments, the keys of which shall not § 316.6 Products not to be removed leave the possession of a Program em- from official establishments unless ployee, or the locker or compartment marked in accordance with the reg- shall be sealed with an official seal of ulations. the Department as prescribed in part No person shall remove or cause to be 312 of this subchapter. removed from an official establishment [35 FR 15577, Oct. 3, 1970, as amended at 36 FR any products which the regulations in 12004, June 24, 1971; 46 FR 38072, July 24, 1981] this subchapter require to be marked in any way unless they are clearly and § 316.5 Branding ink; to be furnished legibly marked in compliance with by official establishments; approval such regulations. by Program; color. (a) The operator of each official es- § 316.7 Marking devices not to be false tablishment shall furnish all ink for or misleading; style and size of let- marking products with the official tering; approval required. marks at such establishment. Such ink No brand or other marking device must be made with harmless ingredi- shall be false or misleading. The letters ents that are approved for the purpose and figures thereon shall be of such by the Administrator. Samples of inks style and type as will make a clear and shall be submitted to the Program lab- legible impression. All markings to be oratory from time to time as may be applied to products in an official estab- deemed necessary by the inspector in charge. lishment shall be approved prior to use by the Administrator as provided for in (b) Only ink approved for the purpose shall be used to apply ink brands bear- § 317.3 of this subchapter, except that ing official marks to carcasses of cat- official markings prescribed by the tle, sheep, swine, or goats and fresh Federal meat grading regulations (7 meat cuts derived therefrom. Any ink CFR 53.19) need not be submitted to the containing F.D. & C. Violet No. 1 shall Administrator for approval.

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§ 316.8 Unmarked inspected products; number of the official establishment moved between official establish- where it was last prepared. Additional ments; moved in commerce. official marks of inspection may be ap- (a) Unmarked products which have plied to products as desired to meet been inspected and passed but do not local conditions. Primal parts are the bear the official inspection legend may wholesale cuts of carcasses as custom- be transported in compliance with part arily distributed to retailers. The 325 of this subchapter from one official round, flank, loin, rib, plate, brisket, establishment to another official es- chuck, and shank are primal parts of tablishment, for further processing, in beef carcasses. Veal, mutton, and goat a railroad car, truck, or other closed primal parts are the leg; flank, loin, container, if the railroad car, truck, or rack, breast, and shoulder. The ham, container is sealed with an official seal belly, loin, shoulder, and jowl are pork of the Department (as prescribed in primal parts. Equine primal parts are part 312 of this subchapter) bearing the the round, flank, loin, rib, plate, bris- official inspection legend. ket, chuck, and shank. (b) Products which have been in- (c) Beef livers shall be marked with spected and passed but do not bear the the official inspection legend con- official inspection legend may be retaining the number of the official es- moved from an official establishment tablishment, at which the cattle in- in closed containers bearing the offi- volved were slaughtered, on the convex cial inspection legend and all other in- surface of the thickest portion of the formation required by this part and organ. part 317 of this subchapter: Provided, (d) Inspected and passed parts of car- That upon removal from such closed casses which are not marked with the container the product may not be fur- official inspection legend under this ther transported in commerce unless section shall not enter any official es- such removal is made under the super- tablishment or be sold, transported, or vision of a Program employee and such offered for sale or transportation, in product is reinspected by a Program commerce, except as provided in § 316.8. employee and packed under his super- [35 FR 15577, Oct. 3, 1970, as amended at 36 FR vision in containers bearing the official 23720, Dec. 14, 1971] inspection legend and all other information required by this part and part § 316.10 Marking of meat food prod- 317 of this subchapter: And provided fur- ucts with official inspection legend ther, That unmarked product shall not and ingredient statement. be brought into an official establish- (a) Inspected and passed sausages and ment in an open container. other products in casings or in link form, of the ordinary ‘‘ring’’ variety or § 316.9 Products to be marked with of- larger shall be marked with the official ficial marks. inspection legend and list of ingredi- (a) Each carcass which has been in- ents in accordance with part 317 of this spected and passed in an official estab- subchapter. The official marks re- lishment shall be marked at the time quired by this section shall be branded of inspection with the official inspec- near each end of the sausage or similar tion legend containing the number of product prepared in casings when the the official establishment. product is of a size larger than that (b) Except as provided otherwise in customarily sold at retail intact. § 316.8, each primal part of a carcass (b) Inspected and passed sausage and and each liver, beef tongue, and beef other products, in casings or in link heart which has been inspected and form, of the smaller varieties, shall passed shall be marked with the offi- bear one or more official inspection cial inspection legend containing the legends and one or more lists of ingre- number of the official establishment dients in accordance with part 317 of before it leaves the establishment in this subchapter on each kilogram (2.205 which it is first inspected and passed, lbs.) of product, except where such and each such inspected and passed products leave the official establish- product shall be marked with the offi- ment completely enclosed in properly cial inspection legend containing the labeled immediate containers having a

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capacity of 5 kilograms (11.025 lbs.) or products: And provided further, That less and containing a single kind of imitation sausage packed in properly product: Provided, That such products labeled containers having a capacity of in properly labeled closed containers 3 pounds or less and of a kind usually exceeding 5 kilograms (11.025 lbs.) ca- sold at retail intact, need not bear the pacity, when shipped to another offi- word ‘‘imitation’’ on each link or piece cial establishment for further proc- if no other marking or labeling is ap- essing or to a governmental agency, plied directly to the product. need only have the official inspection (b) When cereal, vegetable starch, legend and list of ingredients shown starchy vegetable flour, soy flour, soy twice throughout the contents of the protein concentrate, isolated soy pro- container. When such products are tein, dried milk, nonfat dry milk, or shipped to another official establish- calcium reduced dried skim milk is ment for further processing, the inspec- added to sausage in casing or in link tor in charge at the point of origin form within the limits prescribed in shall identify the shipment to the in- part 319 of this subchapter, the prod- spector in charge at destination by ucts shall be marked with the name of means of Form MP 408–1. each added ingredient, as for example (c) The list of ingredients may be ap- ‘‘cereal added,’’ ‘‘potato flour added,’’ plied by stamping, printing, using ‘‘cereal and potato flour added,’’ ‘‘soy paper bands, tags, or tissue strips, or flour added,’’ ‘‘isolated soy protein other means approved by the Adminis- added,’’ ‘‘nonfat dry milk added,’’ trator in specific cases. ‘‘calcium reduced dried skim milk (d) All cured products shall be added,’’ or ‘‘cereal and nonfat dry milk marked with the list of ingredients in added,’’ as the case may be. accordance with part 317 of this sub- (c)(1) When product is placed in a cas- chapter. ing to which artificial coloring is [35 FR 15577, Oct. 3, 1970, as amended at 37 FR thereafter applied, as permitted in part 16863, Aug. 22, 1972; 38 FR 4385, Feb. 14, 1973; 318 of this subchapter, the product 39 FR 36000, Oct. 7, 1974; 44 FR 67088, Nov. 23, shall be legibly and conspicuously 1979] marked by stamping or printing on the § 316.11 Special markings for certain casing the words ‘‘artificially colored.’’ meat food products. (2) If a casing is removed from prod- (a) Meat food products prepared in uct at an official establishment and casing or link form (whether or not there is evidence of artificial coloring thereafter subdivided), other than sau- on the surface of the product, the prod- sage, which possess the characteristics uct from which the casing has been re- of or resemble sausage, shall bear on moved shall be marked by stamping di- each link or piece the word ‘‘imita- rectly thereon the words ‘‘artificially tion’’ prominently displayed: Provided, colored.’’ That the following need not be so (3) The casing containing product marked if they bear on each link or need not be marked to show that it is piece the name of the product in ac- colored if it is colored prior to its use cordance with § 317.2 of this subchapter: as a covering for the product, and the Such products as coppa, capocollo, coloring is of a kind and so applied as lachschinken, bacon, pork loins, pork not to be transferable to the product shoulder butts, and similar cuts of and not to be misleading or deceptive meat which are prepared without added in any respect. substance other than curing materials (d) When an approved artificial or condiments; meat rolls, bockwurst, smoke flavoring or an approved smoke and similar products which do not con- flavoring is added to the formula of tain cereal or vegetables; headcheese, any meat food product as permitted in souse, sulze, scrapple, blood pudding, part 318 of this subchapter, the product and liver pudding; and other products shall be legibly and conspicuously such as loaves, chili con carne, and marked with the words ‘‘Artificial meat and cheese products when pre- Smoke Flavoring Added’’ or ‘‘Smoke pared with sufficient cheese to give Flavoring Added,’’ whichever may be definite characteristics to the finished applicable.

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(e) Subject to the provisions in para- § 316.13 Marking of outside containers. graph (a) of this section, in the case of (a) Except as otherwise provided in sausage of the smaller varieties, the part 325 of this subchapter, when any markings prescribed in this section inspected and passed product for do- may be limited to links bearing the of- mestic commerce is moved from an official inspection legend, and such ficial establishment, the outside con- markings shall not be required if the tainer shall bear an official inspection sausages are packed in properly labeled legend as prescribed in part 312 of this containers having a capacity of 3 subchapter. pounds or less and of a kind usually (b) When any product prepared in an sold at retail intact. Further, all mark- official establishment for domestic ings otherwise required by this section commerce has been inspected and (except those required by paragraph (a) passed and is enclosed in a cloth or of this section) may be omitted from other wrapping, such wrapping shall the casings of sausage and other meat bear the official inspection legend and food products when these products are official establishment number applied by the approved 21⁄2-inch rubber brand to be processed in sealed metal con- in the form prescribed in part 312 of tainers properly labeled in accordance this subchapter: Provided, That the with the requirements in part 317 of rubber brand may be omitted if the of- this subchapter. ficial inspection legend and official es- (f) When an approved antioxidant is tablishment number on the product added to any meat food product as per- itself are clearly legible through the mitted in parts 318 and 319 of this sub- wrapping or the wrapping is labeled in chapter, the products shall be legibly accordance with part 317 of this sub- and conspicuously marked in an ap- chapter: Provided further, That plain proved manner identifying the specific unprinted wrappings, such as antioxidant used by its common name stockinettes, cheesecloth, paper, and or approved abbreviation and the pur- crinkled paper bags, for properly pose for which it is added, such as, marked products, which are used solely ‘‘BHA, BHT, and Propylgallate added to protect the product against soiling to help protect flavor.’’ or excessive drying during transpor- (g) Sausage of the dry varieties treat- tation or storage, need not bear the of- ed with potassium sorbate or ficial inspection legend. (c) The outside containers of prod- propylparaben (propyl p-hydroxy- ucts for export shall be marked in com- benzoate) as permitted by part 318 of pliance with part 322 of this subchapter this subchapter shall be marked as pre- as well as this part. scribed in § 317.8(b)(28) of this sub- (d) Slack barrels used as outside con- chapter). tainers of products shall have a cloth or paper top covering bearing the offi- § 316.12 Marking of equine carcasses cial inspection legend containing the and parts thereof. official establishment number. At the (a) All inspected and passed equine time of removal of the covering, the of- carcasses and parts thereof prepared at ficial inspection legend shall be de- any establishment shall be conspicu- stroyed. ously marked at the time of inspection (e) The outside containers of any with the official inspection legend as product which has been inspected and prescribed in § 312.3 of this subchapter passed for cooking, pork which has and with other information prescribed been refrigerated as provided in for marking products in this part. § 318.10(c) of this subchapter, and beef (b) All equine carcasses and meat and which has been inspected and passed other parts thereof shall be marked to for refrigeration shall bear the mark- show the kinds of animals from which ings and tag prescribed in § 325.7(b) of this subchapter. they were derived, before the products (f) The outside containers of glands are sold, transported, offered for sale or and organs which are not used for transportation, or received for trans- human food purposes, such as those de- portation in commerce. scribed in § 325.19 of this subchapter,

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shall be plainly marked with the the carrier shall remove or obliterate phrase ‘‘For pharmaceutical purposes,’’ such label. ‘‘For organotherapeutic purposes’’ or ‘‘For technical purposes,’’ as appro- [53 FR 28634, July 29, 1988] priate, with no reference to inspection, § 316.15 Marking outside containers of and need not bear other markings oth- inedible grease, etc. erwise required under the regulations in this subchapter. (a) Outside containers of inedible (g) Stencils, box dies, labels, and grease, inedible tallow, or other ined- brands may be used on shipping con- ible animal fat, or mixture of any such tainers of properly labeled products articles, resulting from operations at and on such immediate containers, of any official establishment shall be properly marked products, as tierces, marked conspicuously with the word barrels, drums, boxes, crates, and ‘‘inedible’’ prior to removal from the large-size fiber-board containers, with- point of filling. Containers, such as out approval as provided for in § 317.3 of tierces, barrels, and half barrels shall this subchapter: Provided, That the have both ends painted white with du- stencils, box dies, labels, and brands rable paint, if necessary, to provide a are not false or misleading and are ap- contrasting background, and the word proved by the inspector in charge. The ‘‘inedible’’ shall be marked thereon in official inspection legend for use with letters not less than 2 inches high, such markings shall be approved by the while on tank cars and tank trucks the Administrator as provided for in part letters shall be not less than 4 inches 317 of this subchapter. high. (h) The outside containers of livers (b) Inspected rendered animal fat prepared as described in § 314.10(b), which is intended not to be used for shall be marked as prescribed in human food may also be marked ‘‘in- § 314.10(c) of this subchapter. edible’’ if handled as provided in para- (i) The outside containers of any graph (a) of this section and part 314 of equine product shall be marked to this subchapter. show the kinds of animals from which derived, when the products are sold, § 316.16 Custom prepared products to transported, offered for sale or trans- be marked ‘‘Not for Sale.’’ ported, or received for transportation in commerce. Carcasses and parts therefrom that are prepared on a custom basis under [35 FR 15577, Oct. 3, 1970, as amended at 43 FR § 303.1(a)(2) of this subchapter shall be 29268, July 7, 1978] marked at the time of preparation with the term ‘‘Not for Sale’’ in letters at § 316.14 Marking tank cars and tank trucks used in transportation of ed- least three-eighths inch in height, ex- ible products. cept that such products need not be so marked if in immediate containers Each tank car and each tank truck properly labeled in accordance with the carrying inspected and passed product regulations in § 317.16 of this sub- from an official establishment shall chapter. Ink used for marking such bear a label containing the name of the products must comply with the re- product in accordance with § 317.2 of quirements of § 316.5. this subchapter, the official inspection legend containing the number of the of- [35 FR 15577, Oct. 3, 1970, as amended at 38 FR ficial establishment and the words 29214, Oct. 23, 1973] ‘‘date of loading,’’ followed by a suitable space in which the date the tank PART 317—LABELING, MARKING car or tank truck is loaded shall be in- DEVICES, AND CONTAINERS serted. The label shall be located conspicuously and shall be printed on ma- Subpart A—General terial of such character and so affixed as to preclude detachment or efface- Sec. ment upon exposure to the weather. 317.1 Labels required; supervision by Pro- Before the car or truck is removed gram employee. from the place where it is unloaded, 317.2 Labels: definition; required features.

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317.3 Approval of abbreviations of marks of 317.361 Nutrient content claims for the so- inspection; preparation of marking de- dium content. vices bearing inspection legend without 317.362 Nutrient content claims for fat, advance approval prohibited; exception. fatty acids, and cholesterol content. 317.4 Labeling approval. 317.363 Nutrient content claims for 317.5 Generically approved labeling. ‘‘healthy’’. 317.6 Approved labels to be used only on 317.364–317.368 [Reserved] products to which they are applicable. 317.369 Labeling applications for nutrient 317.7 Products for foreign commerce; print- content claims. ing labels in foreign language permis- 317.370–317.379 [Reserved] sible; other deviations. 317.380 Label statements relating to useful- 317.8 False or misleading labeling or prac- ness in reducing or maintaining body tices generally; specific prohibitions and weight. requirements for labels and containers. 317.381–317.399 [Reserved] 317.9 Labeling of equine products. 317.400 Exemption from nutrition labeling. 317.10 Reuse of official inspection marks; reuse of containers bearing official AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.18, marks, labels, etc. 2.53. 317.11 Labeling, filling of containers, han- SOURCE: 35 FR 15580, Oct. 3, 1970, unless dling of labeled products to be only in otherwise noted. compliance with regulations. 317.12 Relabeling products; requirements. 317.13 Storage and distribution of labels and Subpart A—General containers bearing official marks. 317.14–317.15 [Reserved] § 317.1 Labels required; supervision by 317.16 Labeling and containers of custom Program employee. prepared products. (a) When, in an official establish- 317.17 Interpretation and statement of la- ment, any inspected and passed prod- beling policy for cured products; special uct is placed in any receptacle or cov- labeling requirements concerning nitrate ering constituting an immediate con- and nitrite. 317.18–317.23 [Reserved] tainer, there shall be affixed to such 317.24 Packaging materials. container a label as described in § 317.2 except that the following do not have Subpart B—Nutrition Labeling to bear such a label. (1) Wrappings of dressed carcasses 317.300 Nutrition labeling of meat or meat food products. and primal parts in an unprocessed 317.301 Required nutrition labeling of state, bearing the official inspection ground or chopped meat products. legend, if such wrappings are intended 317.302 Location of nutrition information. solely to protect the product against 317.303–317.307 [Reserved] soiling or excessive drying during 317.308 Labeling of meat or meat food prod- transportation or storage, and the ucts with number of servings. wrappings bear no information except 317.309 Nutrition label content. company brand names, trade marks, or 317.310–317.311 [Reserved] 317.312 Reference amounts customarily con- code numbers which do not include any sumed per eating occasion. information required by § 317.2; 317.313 Nutrient content claims; general (2) Uncolored transparent coverings, principles. such as cellophane, which bear no writ- 317.314–317.342 [Reserved] ten, printed, or graphic matter and 317.343 Significant participation for vol- which enclose any unpackaged or pack- untary nutrition labeling. aged product bearing all markings re- 317.344 Identification of major cuts of meat products. quired by part 316 of this subchapter 317.345 Guidelines for voluntary nutrition which are clearly legible through such labeling of single-ingredient, raw prod- coverings; ucts. (3) Animal and transparent artificial 317.346–317.353 [Reserved] casings bearing only the markings re- 317.354 Nutrient content claims for ‘‘good quired by part 316 of this subchapter; source,’’ ‘‘high,’’ and ‘‘more’’. (4) Stockinettes used as ‘‘operative 317.355 [Reserved] devices’’, such as those applied to cured 317.356 Nutrient content claims for ‘‘light’’ or ‘‘lite’’. meats in preparation for smoking, 317.357–317.359 [Reserved] whether or not such stockinettes are 317.360 Nutrient content claims for calorie removed following completion of the content. operations for which they were applied;

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(5) Containers such as boil-in bags, pear thereon in the English language: trays of frozen dinners, and pie pans Provided, however, That in the case of which bear no information except com- products distributed solely in Puerto pany brand names, trademarks, code Rico, Spanish may be substituted for numbers, directions for preparation English for all printed matter except and serving suggestions, and which are the USDA inspection legend. enclosed in a consumer size container (c) Labels of all products shall show that bears a label as described in § 317.2; the following information on the prin- (6) Containers of products passed for cipal display panel (except as otherwise cooking or refrigeration and moved permitted in this part), in accordance from an official establishment under with the requirements of this part or, § 311.1 of this subchapter. if applicable, part 319 of this sub- (b) Folders and similar coverings chapter: made of paper or similar materials, (1) The name of the product, which in whether or not they completely enclose the case of a product which purports to the product and which bear any writ- be or is represented as a product for ten, printed, or graphic matter, shall which a definition and standard of bear all features required on a label for identity or composition is prescribed in an immediate container. part 319 of this subchapter, shall be the (c) No covering or other container name of the food specified in the stand- which bears or is to bear a label shall ard, and in the case of any other prod- be filled, in whole or in part, except uct shall be the common or usual name with product which has been inspected of the food, if any there be, and if there and passed in compliance with the reg- is none, a truthful descriptive designa- ulations in this subchapter, which is tion, as prescribed in paragraph (e) of not adulterated and which is strictly in this section; accordance with the statements on the (2) If the product is fabricated from label. No such container shall be filled, two or more ingredients, the word ‘‘in- in whole or in part, and no label shall gredients’’ followed by a list of the in- be affixed thereto, except under supervision of a Program employee. gredients as prescribed in paragraph (f) of this section; § 317.2 Labels: definition; required fea- (3) The name and place of business of tures. the manufacturer, packer, or dis- (a) A label within the meaning of this tributor for whom the product is pre- part shall mean a display of any print- pared, as prescribed in paragraph (g) of ing, lithographing, embossing, stickers, this section; seals, or other written, printed, or (4) An accurate statement of the net graphic matter upon the immediate quantity of contents, as prescribed in container (not including package lin- paragraph (h) of this section; ers) of any product. (5) An official inspection legend and, (b) Any word, statement, or other in- except as otherwise provided in para- formation required by this part to ap- graph (i) of this section, the number of pear on the label must be prominently the official establishment, in the form placed thereon with such conspicuous- required by part 312 of this subchapter; ness (as compared with other words, (6) Any other information required statements, designs, or devices, in the by the regulations in this part or part labeling) and in such terms as to 319 of this subchapter. render it likely to be read and under- (d) The principal display panel shall stood by the ordinary individual under be the part of a label that is most like- customary conditions of purchase and ly to be displayed, presented, shown, or use. In order to meet this requirement, examined under customary conditions such information must appear on the of display for sale. Where packages principal display panel except as other- bear alternate principal display panels, wise permitted in this part. Except as information required to be placed on provided in § 317.7, all words, state- the principal display panel shall be du- ments, and other information required plicated on each principal display by or under authority of the Act to ap- panel. The principal display panel shall pear on the label or labeling shall ap- be large enough to accommodate all

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the mandatory label information re- ‘‘daisy’’ shall not be used as names of a quired to be placed thereon by this part product unless accompanied with terms and part 319 of this subchapter with descriptive of the product or with a list clarity and conspicuousness and with- of ingredients, as deemed necessary in out obscuring of such information by any specific case by the Administrator designs or vignettes or crowding. In de- in order to assure that the label will termining the area of the principal dis- not be false or misleading. play panel, exclude tops, bottoms, (f)(1) The list of ingredients shall flanges at tops and bottoms of cans, show the common or usual names of and shoulders and necks of bottles or the ingredients arranged in the de- jars. The principal display panel shall scending order of predominance, except be: as otherwise provided in this para- (1) In the case of a rectangular pack- graph. age, one entire side, the area of which (i) The terms spice, natural flavor, is at least the product of the height natural flavoring, flavor and flavoring times the width of that side. may be used in the following manner: (2) In the case of a cylindrical or (A) The term ‘‘spice’’ means any aro- nearly cylindrical container: matic vegetable substance in the (i) An area that is 40 percent of the whole, broken, or ground form, with product of the height of the container the exceptions of onions, garlic and times the circumference of the con- celery, whose primary function in food tainer, or is seasoning rather than nutritional (ii) A panel, the width of which is and from which no portion of any vola- one-third of the circumference and the tile oil or other flavoring principle has height of which is as high as the con- been removed. Spices include the spices tainer: Provided, however, That if there listed in 21 CFR 182.10, and 184. is immediately to the right or left of (B) The term ‘‘natural flavor,’’ ‘‘nat- such principal display panel, a panel ural flavoring,’’ ‘‘flavor’’ or ‘‘fla- which has a width not greater than 20 voring’’ means the essential oil, oleo- percent of the circumference and a resin, essence or extractive, protein hy- height as high as the container, and drolysate, distillate, or any product or which is reserved for information pre- roasting, heating or enzymolysis, scribed in paragraphs (c) (2), (3), and which contains the flavoring constitu- (5), such panel shall be known as the ents derived from a spice, fruit or fruit ‘‘20 percent panel’’ and such informa- juice, vegetable or vegetable juice, edition may be shown on that panel in ble yeast, herb, bark, bud, root, leaf or lieu of showing it on the principal dis- any other edible portion of a plant, play panel. meat, seafood, poultry, eggs, dairy (3) In the case of a container of any products, or fermentation products other shape, 40 percent of the total sur- thereof, whose primary function in face of the container. food is flavoring rather than nutri- (e) Any descriptive designation used tional. Natural flavors include the nat- as a product name for a product which ural essence or extractives obtained has no common or usual name shall from plants listed in 21 CFR 182.10, clearly and completely identify the 182.20, 182.40, 182.50 and 184, and the product. Product which has been pre- substances listed in 21 CFR 172.510. The pared by salting, smoking, drying, term natural flavor, natural flavoring, cooking, chopping, or otherwise shall flavor or flavoring may also be used to be so described on the label unless the designate spices, powered onion, pow- name of the product implies, or the dered garlic, and powdered celery. manner of packaging shows that the (ii) The term ‘‘corn syrup’’ may be product was subjected to such prepara- used to designate either corn syrup or tion. The unqualified terms ‘‘meat,’’ corn syrup solids. ‘‘meat byproduct,’’ ‘‘meat food prod- (iii) The term ‘‘animal and vegetable uct,’’ and terms common to the meat fats’’ or ‘‘vegetable and animal fats’’ industry but not common to consumers may be used to designate the ingredi- such as ‘‘picnic,’’ ‘‘butt,’’ ‘‘cala,’’ ents of mixtures of such edible fats in ‘‘square,’’ ‘‘loaf,’’ ‘‘spread,’’ ‘‘delight,’’ product designated ‘‘compound’’ or ‘‘roll,’’ ‘‘plate,’’ ‘‘luncheon,’’ and ‘‘shortening.’’ ‘‘Animal fats’’ as used

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herein means fat derived from in- not exceed the amount shown in the spected and passed cattle, sheep, swine, quantifying statement. Any such ad- or goats. justments to the formulation shall be (iv) When a product is coated with provided to the inspector-in-charge. pork fat, gelatin, or other approved (2) On containers of frozen dinners, substance and a specific declaration of entrees, pizzas, and similar consumer such coating appears contiguous to the packaged products in cartons the in- name of the product, the ingredient gredient statement may be placed on statement need not make reference to the front riser panel: Provided, That the ingredients of such coating. the words ‘‘see ingredients’’ followed (v) When two meat ingredients com- immediately by an arrow is placed on prise at least 70 percent of the meat the principal display panel imme- and meat byproduct ingredients of a diately above the location of such formula and when neither of the two statement without intervening print or meat ingredients is less than 30 percent designs. by weight of the total meat and meat (3) The ingredient statement may be byproducts used, such meat ingredients placed on the 20 percent panel adjacent may be interchanged in the formula to the principal display panel and re- without a change being made in the in- served for required information, in the gredients statement on labeling mate- case of a cylindrical or nearly cylin- rials: Provided, That the word ‘‘and’’ in drical container. lieu of a comma shall be shown be- (4) The ingredients statement may be tween the declaration of such meat in- placed on the information panel, ex- gredients in the statement of ingredi- cept as otherwise permitted in this ents. subchapter. (vi)(A) Product ingredients which are (g)(1) The name or trade name of the present in individual amounts of 2 per- person that prepared the product may cent or less by weight may be listed in appear as the name of the manufac- the ingredients statement in other turer or packer without qualification than descending order of predomi- on the label. Otherwise the name of the nance: Provided, That such ingredients distributor of the product shall be are listed by their common or usual shown with a phrase such as ‘‘Prepared names at the end of the ingredients for * * *’’. The place of business of the statement and preceded by a quanti- manufacturer, packer, or distributor fying statement, such as ‘‘Contains shall be shown on the label by city, percent of ,’’ ‘‘Less lllll lllll State, and postal ZIP code when such than percent of .’’ lllll lllll business is listed in a telephone or city The percentage of the ingredient(s) directory, and if not listed in such di- shall be filled in with a threshold level rectory, then the place of business of 2 percent, 1.5 percent, 1.0 percent, or shall be shown by street address, city, 0.5 percent, as appropriate. No ingre- State, and postal ZIP code. dient to which the quantifying statement applies may be present in an (2) The name and place of business of amount greater than the stated thresh- the manufacturer, packer, or dis- old. Such a quantifying statement may tributor may be shown: also be utilized when an ingredients (i) On the principal display panel, or statement contains a listing of ingredi- (ii) On the 20 percent panel adjacent ents by individual components. Each to the principal display panel and re- component listing may utilize the reserved for required information, in the quired quantifying statement at the case of a cylindrical or nearly cylin- end of each component ingredients list- drical container, or ing. (iii) On the front riser panel of frozen (B) Such ingredients may be adjusted food cartons, or in the product formulation without a (iv) On the information panel. change being made in the ingredients (h)(1) The statement of net quantity statement on the labeling, provided of contents shall appear on the prin- that the adjusted amount complies cipal display panel of all containers to with part 319 of this subchapter and be sold at retail intact, in conspicuous with § 424.21 of subchapter E, and does and easily legible boldface print or

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type in distinct contrast to other mat- (5) On packages containing 1 pound ter on the container, and shall be de- or 1 pint and less than 4 pounds or 1 clared in accordance with the provi- gallon, the statement shall be ex- sions of this paragraph. pressed as a dual declaration both in (2) The statement as it is shown on a ounces and (immediately thereafter in label shall not be false or misleading parentheses) in pounds, with any re- and shall express an accurate state- mainder in terms of ounces or common ment of the quantity of contents of the or decimal fraction of the pound, or in container. Reasonable variations the case of liquid measure, in the larg- caused by loss or gain of moisture dur- est whole units with any remainder in ing the course of good distribution terms of fluid ounces or common or practices or by unavoidable deviations decimal fractions of the pint or quart, in good manufacturing practices will except that on random weight pack- be recognized. Variations from stated ages the statement shall be expressed quantity of contents shall be as pro- in terms of pounds and decimal frac- vided in § 317.19. The statement shall tions of the pound, for packages over 1 not include any term qualifying a unit pound, and for packages which do not of weight, measure, or count such as exceed 1 pound the statement may be ‘‘jumbo quart,’’ ‘‘full gallon,’’ ‘‘giant in decimal fractions of the pound in quart,’’ ‘‘when packed,’’ ‘‘minimum,’’ lieu of ounces. Paragraph (h)(9) of this or words of similar importance. section permits certain exceptions from the provisions of this paragraph (3) The statement shall be placed on for margarine packages, random the principal display panel within the weight consumer size packages, and bottom 30 percent of the area of the packages of less than 1⁄2 ounce net panel in lines generally parallel to the weight. Pargraph (h)(12) of this section base: Provided, That on packages hav- permits certain exceptions from the ing a principal display panel of 5 square provision of this paragraph for multi- inches or less, the requirement for unit packages. placement within the bottom 30 per- (6) The statement shall be in letters cent of the area of the label panel shall and numerals in type size established not apply when the statement meets in relationship to the area of the prin- the other requirements of this para- cipal display panel of the package and graph (h). In any case, the statement shall be uniform of all packages of sub- may appear in more than one line. The stantially the same size by complying terms ‘‘net weight’’ or ‘‘net wt.’’ shall with the following type specifications: be used when stating the net quantity (i) Not less than one-sixteenth inch of contents in terms of weight, and the in height on packages, the principal term ‘‘net contents’’ or ‘‘content’’ display panel of which has an area of 5 when stating the net quantity of con- square inches or less; tents in terms of fluid measure. (ii) Not less than one-eighth inch in (4) Except as provided in § 317.7, the height on packages, the principal dis- statement shall be expressed in terms play panel of which has an area of more of avoirdupois weight or liquid meas- than 5 but not more than 25 square ure. Where no general consumer usage inches; to the contrary exists, the statement (iii) Not less than three-sixteenths shall be in terms of liquid measure, if inch in height on packages, the prin- the product is liquid, or in terms of cipal display panel of which has an weight if the product is solid, semisolid area of more than 25 but not more than viscous or a mixture of solid and liquid. 100 square inches; For example, a declaration of 3⁄4-pound (iv) Not less than one-quarter inch in avoirdupois weight shall be expressed height on packages, the principal dis- as ‘‘Net Wt. 12 oz.’’ except as provided play panel of which has an area of more for in paragraph (h)(5) of this section than 100 but not more than 400 square for random weight packages; a declara- inches. tion of 11⁄2 pounds avoirdupois weight (v) Not less than one-half inch in shall be expressed as ‘‘Net Wt. 24 oz. (1 height on packages, the principal dis- lb. 8 oz.),’’ ‘‘Net Wt. 24 oz. (11⁄2 lb.),’’ or play panel of which has an area of more ‘‘Net Wt. 24 oz. (1.5 lbs.).’’ than 400 square inches.

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(7) The ratio of height to width of let- play and sale. The net weight state- ters and numerals shall not exceed a ment on random weight consumer size differential of 3 units to 1 unit (no packages for retail sale shall be exempt more than 3 times as high as it is from the type size, dual declaration, wide). Heights pertain to upper case or and placement requirements of this capital letters. When upper and lower paragraph, if an accurate statement of case or all lower case letters are used, net weight is shown conspicuously on it is the lower case letter ‘‘o’’ or its the principal display panel of the pack- equivalent that shall meet the min- age. imum standards. When fractions are (ii) Individually wrapped and labeled used, each component numeral shall packages of less than 1⁄2 ounce net meet one-half the height standards. weight and random weight consumer (8) The statement shall appear as a size packages shall be exempt from the distinct item on the principal display requirements of this paragraph if they panel and shall be separated by a space are in a shipping container and the at least equal to the height of the let- statement of net quantity of contents tering used in the statement from on the shipping container meets the re- other printed label information appear- quirements of paragraph (h)(2) of this ing above or below the statement and section; by a space at least equal to twice the (iii) Individually wrapped and labeled width of the letter ‘‘N’’ of the style of packages of less than 1⁄2 ounce net type used in the quantity of contents weight bearing labels declaring net statement from other printed label in- weight, price per pound, and total formation appearing to the left or right price, shall be exempt from the type of the statement. It shall not include size, dual declaration, and placement any term qualifying a unit of weight, requirements of this paragraph, if an measure, or count such as, ‘‘jumbo accurate statement of net weight is quart,’’ ‘‘full gallon,’’ ‘‘giant quart,’’ shown conspicuously on the principal ‘‘when packed,’’ ‘‘Minimum’’ or words display panel of the package. of similar import. (iv) Margarine in 1 pound rectangular (9) The following exemptions from packages (except packages containing the requirements contained in this whipped or soft margarine or packages paragraph (h) are hereby established: that contain more than four sticks) is (i) Individually wrapped, random exempt from the requirements of para- weight consumer size packages shipped graphs (h) (3) and (5) of this section rein bulk containers (as specified in para- garding the placement of the state- graph (h)(11) of this section) and meat ment of the net quantity of contents products that are subject to shrinkage within the bottom 30 percent of the through moisture loss during good dis- principal display panel and that the tribution practices and are designated statement be expressed both in ounces as gray area type of products as defined and in pounds, if the statement appears under § 317.19 need not bear a net as ‘‘1 pound’’ or ‘‘one pound’’ in a con- weight statement when shipped from spicuous manner on the principal dis- an official establishment, provided play panel. that a net weight shipping statement (v) Sliced shingle packed bacon in which meets the requirements of para- rectangular packages is exempt from graph (h)(2) of this section is applied to the requirements of paragraphs (h)(3) their shipping container prior to ship- and (h)(5) of this section regarding the ping it from the official establishment. placement of the statement of the net Net weight statements so applied to quantity of contents within the bottom the shipping container are exempt from 30 percent of the principal display the type size, dual declaration, and panel, and that the statement be ex- placement requirements of this para- pressed both in ounces and in pounds, if graph, if an accurate statement of net the statement appears in a conspicuous weight is shown conspicuously on the manner on the principal display panel. principal display panel of the shipping (10) Labels for containers which bear container. The net weight also shall be any representation as to the number of applied directly to random weight con- servings contained therein shall bear, sumer size packages prior to retail dis- contiguous to such representation, and

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in the same size type as is used for packaging or labeling material in the such representation, a statement of the container, e.g., on aluminum pans and net quantity of each such serving. trays placed within containers, when a (11) As used in this section, a ‘‘ran- statement of its location is printed dom weight consumer size package’’ is contiguous to the official inspection one which is one of a lot, shipment or legend, such as ‘‘EST. No. on Metal delivery of packages of the same prod- Clip’’ or ‘‘Est. No. on Pan’’, if shown in uct with varying weights and with no a prominent and legible manner in a fixed weight pattern. size sufficient to insure easy visibility (12) On a multiunit retail package, a and recognition; or statement of the net quantity of con- (4) On an insert label placed under a tents shall appear on the outside of the transparent covering if clearly visible package and shall include the number and legible and accompanied by the of individual units, the quantity of prefix ‘‘EST’’. each individual unit, and in paren- (j) Labels of any product within any theses, the total net quantity of con- of the following paragraphs shall show tents of the multiunit package in the information required by such para- terms of avoirdupois or fluid ounces, graph for such product: except that such declaration of total (1) A label for product which is an quantity need not be followed by an ad- imitation of another food shall bear ditional parenthetical declaration in the word ‘‘imitation’’ immediately pre- terms of the largest whole units and ceding the name of the food imitated subdivisions thereof, as required by and in the same size and style of let- paragraph (h)(5) of this section. For the tering as in that name and imme- purposes of this section, ‘‘multiunit re- diately thereafter the word ‘‘ingredi- tail package’’ means a package con- ents:’’ and the names of the ingredients taining two or more individually pack- arranged in the order of their predomi- aged units of the identical commodity nance. and in the same quantity, with the in- (2) If a product purports to be or is dividual packages intended to be sold represented for any special dietary use as part of the multiunit retail package by man, its label shall bear a state- but capable of being individually sold ment concerning its vitamin, mineral, in full compliance with all require- and other dietary properties upon ments of the regulations in this part. which the claim for such use is based in Open multiunit retail packages that do whole or in part and shall be in con- not obscure the number of units and formity with regulations (21 CFR part the labeling thereon are not subject to 125) established pursuant to sections this paragraph if the labeling of each 403, and 701 of the Federal Food, Drug, individual unit complies with the re- and Cosmetic Act (21 U.S.C. 343, 371). quirements of paragraphs (h) (2), (3), (3) When an artificial smoke fla- (6), and (8) of this section. voring or a smoke flavoring is added as (i) The official establishment number an ingredient in the formula of a meat of the official establishment in which food product, as permitted in part 318 the product was processed under in- of this subchapter, there shall appear spection shall be placed as follows: on the label, in prominent letters and (1) Within the official inspection leg- contiguous to the name of the product, end in the form required by part 312 of a statement such as ‘‘Artificial Smoke this subchapter; or Flavoring Added’’ or ‘‘Smoke Fla- (2) Outside the official inspection leg- voring Added,’’ as may be applicable, end elsewhere on the exterior of the and the ingredient statement shall container or its labeling, e.g., the lid of identify any artificial smoke flavoring a can, if shown in a prominent and leg- or smoke flavoring so added as an in- ible manner in a size sufficient to ingredient in the formula of the meat sure easy visibility and recognition and food product. accompanied by the prefix ‘‘EST’’; or (4) When any other artificial fla- (3) Off the exterior of the container, voring is permitted under part 318 of e.g., on a metal clip used to close cas- this subchapter to be added to a prod- ings or bags, or on the back of a paper uct, the ingredient statement shall label of a canned product, or on other identify it as ‘‘Artificial Flavoring.’’

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(5) When artificial coloring is added use of such preservative shall, at the to edible fats as permitted under part time of packing, be marked ‘‘for ex- 318 of this subchapter such substance port,’’ followed on the next line by the shall be declared on the label in a words ‘‘packed in preservative,’’ or prominent manner and contiguous to such equivalent statement as may be the name of the product by the words approved for this purpose by the Ad- ‘‘Artificially colored’’ or ‘‘Artificial ministrator and directly beneath this coloring added’’ or ‘‘With added artifi- there shall appear the word ‘‘establish- cial coloring.’’ When natural coloring ment’’ or abbreviation thereof, fol- such as annatto is added to edible fats lowed by the number of the establish- as permitted under part 318 of this sub- ment at which the product is packed. chapter, such substance shall be de- The complete statement shall be ap- clared on the label in the same manner plied in a conspicuous location and in by a phrase such as ‘‘Colored with letters not less than 1 inch in height. annatto.’’ (12) Containers of other product (6) When product is placed in a casing packed in, bearing, or containing any to which artificial coloring is applied chemical preservative shall bear a as permitted under part 318 of this sub- label stating that fact. chapter, there shall appear on the (13)(i) On the label of any ‘‘Mechani- label, in a prominent manner and con- cally Separated (Species)’’ described in tiguous to the name of the product, the § 319.5(a) of this subchapter, the name words, ‘‘Artificially colored.’’ of such product shall be followed im- (7) If a casing is removed from prod- mediately by the phrase ‘‘for proc- uct at an official establishment and essing’’ unless such product has a pro- there is evidence of artificial coloring tein content of not less than 14 percent on the surface of the product, there and a fat content of not more than 30 shall appear on the label, in a promi- percent. nent manner and contiguous to the (ii) When any ‘‘Mechanically Sepa- name of product, the words ‘‘Artifi- rated (Species)’’ described in § 319.5 of cially colored.’’ this subchapter is used as an ingredient (8) When a casing is colored prior to in the preparation of a meat food prod- its use as a covering for product and uct and such ‘‘Mechanically Separated the color is not transferred to the prod- (Species)’’ contributes 20 mg or more of uct enclosed in the casing, no reference calcium to a serving of such meat food to color need appear on the label but product, the label of such meat food no such casing may be used if it is mis- product shall state the calcium content leading or deceptive with respect to of such meat food product, determined color, quality, or kind of product, or and expressed as the percentage of the otherwise. U.S. Recommended Daily Allowance (9) Product which bears or contains (U.S. RDA) in a serving in accordance any other artificial coloring, as per- with 21 CFR 101.9(b)(1), (c)(7) (i) and mitted under part 318 of this sub- (iv), and (e), as part of any nutrition chapter, shall bear a label stating that information included on such label, or fact on the immediate container or if if such meat food product does not bear there is none, on the product. nutrition labeling information, as part (10) When an antioxidant is added to of a prominent statement in immediate product as permitted under part 318 of conjunction with the list of ingredi- this subchapter, there shall appear on ents, as follows: ‘‘A lll serving con- the label in prominent letters and contains ll% of the U.S. RDA of cal- tiguous to the name of the product, a cium’’, with the blanks to be filled in, statement identifying the officially ap- respectively, with the quantity of such proved specific antioxidant by its com- product that constitutes a serving and mon name or abbreviation thereof and the amount of calcium provided by the purpose for which it is added, such such serving: Provided, That, calcium as, ‘‘BHA, BHT, and Propylgallate content need not be stated where (a) added to help protect flavor.’’ the percent of the U.S. RDA of calcium (11) Containers of meat packed in to be declared would not differ from borax or other preservative for export the percent of the U.S. RDA that would to a foreign country which permits the be declared if the meat food product

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contained only hand deboned ingredi- with other words, statements, designs ents or (b) the calcium content of a or devices in the labeling) as to render serving of the meat food product would it likely to be read and understood by be 20 percent of the U.S. RDA or more the ordinary individual under cus- if the meat food product contained tomary conditions of purchase and use. only hand deboned ingredients. (ii) The safe handling information (k) Packaged products which require shall be presented on the label under special handling to maintain their the heading ‘‘Safe Handling Instruc- wholesome condition shall have promi- tions’’ which shall be set in type size nently displayed on the principal dis- larger than the print size of the ration- play panel of the label the statement: ale statement and handling statements ‘‘Keep Refrigerated,’’ ‘‘Keep Frozen,’’ as discussed in paragraphs (l)(2) and ‘‘Perishable Keep Under Refrigera- (l)(3) of this section. The safe handling tion,’’ or such similar statement as the information shall be set off by a border Administrator may approve in specific and shall be one color type printed on cases. Products that are distributed a single color contrasting background frozen during distribution and thawed whenever practical. prior to or during display for sale at re- (2) The labels of the meat and meat tail shall bear the statement on the products specified in this paragraph (l) shipping container: ‘‘Keep Frozen.’’ shall include the following rationale The consumer-size containers for such statement as part of the safe handling products shall bear the statement instructions, ‘‘This product was pre- ‘‘Previously Handled Frozen for Your pared from inspected and passed meat Protection, Refreeze or Keep Refrig- and/or poultry. Some food products erated.’’ For all perishable canned may contain bacteria that could cause products the statement shall be shown illness if the product is mishandled or in upper case letters one-fourth inch in cooked improperly. For your protec- height for containers having a net tion, follow these safe handling in- weight of 3 pounds or less, and for con- structions.’’ This statement shall be tainers having a net weight over 3 placed immediately after the heading pounds, the statement shall be in upper and before the safe handling state- case letters at least one-half inch in ments. height. (l) Safe handling instructions shall be (3) Meat and meat products, specified provided for: All meat and meat prod- in this paragraph (l), shall bear the la- ucts of cattle, swine, sheep, goat, beling statements: horse, other equine that do not meet (i) Keep refrigerated or frozen. Thaw the requirements contained in § 318.17, in refrigerator or microwave. (Any por- or that have not undergone other proc- tion of this statement that is in con- essing that would render them ready- flict with the product’s specific han- to-eat; and all comminuted meat pat- dling instructions, may be omitted, ties not heat processed in a manner e.g., instructions to cook without that conforms to the time and tem- thawing.) (A graphic illustration of a perature combinations in the Table for refrigerator shall be displayed next to Permitted Heat-Processing Tempera- the statement.); ture/Time Combinations For Fully- (ii) Keep raw meat and poultry sepa- Cooked Patties in § 318.23, except as ex- rate from other foods. Wash working empted under paragraph (l)(4) of this surfaces (including cutting boards), section. utensils, and hands after touching raw (1)(i) Safe handling instructions shall meat or poultry. (A graphic illustra- accompany every meat or meat prod- tion of soapy hands under a faucet uct, specified in this paragraph (l) des- shall be displayed next to the state- tined for household consumers, hotels, ment.); restaurants, or similar institutions and (iii) Cook thoroughly. (A graphic il- shall appear on the label. The informa- lustration of a skillet shall be dis- tion shall be in lettering no smaller played next to the statement.); and than one-sixteenth of an inch in size (iv) Keep hot foods hot. Refrigerate and shall be prominently placed with leftovers immediately or discard. (A such conspicuousness (as compared graphic illustration of a thermometer

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shall be displayed next to the state- Sections Affected, which appears in the ment.) Finding Aids section of the printed volume (4) Meat or meat products intended and at www.fdsys.gov. for further processing at another official establishment are exempt from the § 317.3 Approval of abbreviations of requirements prescribed in paragraphs marks of inspection; preparation of (l)(1) through (l)(3) of this section. marking devices bearing inspection legend without advance approval (m)(1) The information panel is that prohibited; exception. part of a label that is the first surface to the right of the principal display (a) The Administrator may approve panel as observed by an individual fac- and authorize the use of abbreviations ing the principal display panel, with of marks of inspection under the regu- the following exceptions: lations in this subchapter. Such abbre- (i) If the first surface to the right of viations shall have the same force and the principal display panel is too small effect as the respective marks for to accommodate the required informa- which they are authorized abbreviation or is otherwise unusable label tions. space, e.g., folded flaps, tear strips, (b) Except for the purposes of pre- opening flaps, heat-sealed flaps, the paring and submitting a sample or next panel to the right of this part of samples of the same to the Adminis- the label may be used. trator for approval, no brand manufac- (ii) If the package has one or more al- turer, printer, or other person shall ternate principal display panels, the in- cast, print, lithograph, or otherwise formation panel is to the right of any make any marking device containing principal display panel. any official mark or simulation there- (iii) If the top of the container is the principal display panel and the pack- of, or any label bearing any such mark age has no alternate principal display or simulation, without the written au- panel, the information panel is any thority therefor of the Administrator. panel adjacent to the principal display However, when any such sample label, panel. or other marking device, is approved (2) (i) Except as otherwise permitted by the Administrator, additional sup- in this part, all information required to plies of the approved label, or marking appear on the principal display panel device, may be made for use in accord- or permitted to appear on the informa- ance with the regulations in this sub- tion panel shall appear on the same chapter, without further approval by panel unless there is insufficient space. the Administrator. The provisions of In determining the sufficiency of the this paragraph apply only to labels, or available space, except as otherwise other marking devices, bearing or con- prescribed in this part, any vignettes, taining an official inspection legend designs, and any other nonmandatory shown in § 312.2(b), § 312.3(a) (only the information shall not be considered. If legend appropriate for horse meat food there is insufficient space for all re- products) or § 312.3(b) (only the legend quired information to appear on a sin- appropriate for other (nonhorse) equine gle panel, it may be divided between meat food products), or any abbrevia- the principal display panel and the in- tions, copy or representation thereof. formation panel, provided that the in- (c) No brand manufacturer or other formation required by any given provi- person shall cast or otherwise make, sion of this part, such as the ingredi- without an official certificate issued in ents statement, is not divided and ap- quadruplicate by a Program employee, pears on the same panel. a brand or other marking device con- (ii) All information appearing on the taining an official inspection legend, or information panel pursuant to this sec- simulation thereof, shown in § 312.2(a), tion shall appear in one place without § 312.3(a) (only the legend appropriate intervening material, such as designs for horse carcasses and parts of horse or vignettes. carcasses), § 312.3(b) (only the legend [35 FR 15580, Oct. 3, 1970] appropriate for other equine (nonhorse) EDITORIAL NOTE: For FEDERAL REGISTER ci- carcasses and parts of other (nonhorse) tations affecting § 317.2, see the List of CFR equine carcasses) or § 312.7(a).

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(1) The certificate is a Food Safety panied by FSIS form, Application for and Inspection Service form for signa- Approval of Labels, Marking, and De- ture by a Program employee and the vices, except for generically approved official establishment ordering the labeling authorized for use in § 317.5(b). brand or other marking device, bearing The management of the official estab- a certificate serial number and a let- lishment or establishment certified terhead and the seal of the United under a foreign inspection system, in States Department of Agriculture. The accordance with part 327 of this sub- certificate authorizes the making of chapter, must maintain a copy of all only the brands or other marking de- labeling used, along with the product vices of the type and quantity listed on formulation and processing procedure, the certificate. in accordance with part 320 of this sub- (2) After signing the certificate, the chapter. Such records shall be made Program employee and the establish- available to any duly authorized rep- ment shall each keep a copy, and the resentative of the Secretary upon re- remaining two copies shall be given to quest. the brand or other marking device (b) The Food Labeling Division shall manufacturer. permit submission for approval of only (3) The manufacturer of the brands or other marking devices shall engrave or sketch labeling, as defined in § 317.4(d), otherwise mark each brand or other for all products, except as provided in marking device with a permanent iden- § 317.5(b) (2)–(9) and except for tem- tifying serial number unique to it. The porary use of final labeling as pre- manufacturer shall list on each of the scribed in paragraph (f) of this section. two copies of the certificate given to (c) All labeling required to be sub- the manufacturer the number of each mitted for approval as set forth in brand or other marking device author- § 317.4(a) shall be submitted in dupli- ized by the certificate. The manufac- cate to the Food Labeling Division, turer shall retain one copy of the cer- Regulatory Programs, Food Safety and tificate for the manufacturer’s records Inspection Service, U.S. Department of and return the remaining copy with Agriculture, Washington, DC 20250. A the brands or other marking devices to parent company for a corporation may the Program employee whose name and submit only one labeling application address are given on the certificate as (in duplicate form) for a product pro- the recipient. duced in other establishments that are (4) In order that all such brands or owned by the corporation. other marking devices bear identifying (d) ‘‘Sketch’’ labeling is a printer’s numbers, within one year after June 24, proof or equivalent which clearly 1985, an establishment shall either re- shows all labeling features, size, loca- place each such brand or other mark- tion, and indication of final color, as ing device which does not bear an iden- specified in § 317.2. FSIS will accept tifying number, or, under the direction sketches that are hand drawn, com- of the inspector-in-charge, mark such puter generated or other reasonable brand or other marking device with a facsimiles that clearly reflect and permanent identifying number. project the final version of the label- (Recordkeeping requirements approved by ing. Indication of final color may be the Office of Management and Budget under met by: submission of a color sketch, control number 0583–0015) submission of a sketch which indicates [35 FR 15580, Oct. 3, 1970, as amended at 50 FR by descriptive language the final col- 21422, May 24, 1985] ors, or submission with the sketch of previously approved final labeling that § 317.4 Labeling approval. indicates the final colors. (a) No final labeling shall be used on (e) Inserts, tags, liners, pasters, and any product unless the sketch labeling like devices containing printed or of such final labeling has been sub- graphic matter and for use on, or to be mitted for approval to the Food Label- placed within, containers and coverings ing Division, Regulatory Programs, of product shall be submitted for ap- Food Safety and Inspection Service, proval in the same manner as provided and approved by such division, accom- for labeling in § 317.4(a), except that

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such devices which contain no ref- lishments and establishments certified erence to product and bear no mis- under foreign inspection systems, in leading feature shall be used without accordance with part 327 of this sub- submission for approval as prescribed chapter, as required in § 317.4, to deter- in § 317.5(b)(7). mine compliance with labeling require- (f)(1) Consistent with the requirements. Any finding of false or mis- ments of this section, temporary ap- leading labeling shall institute the pro- proval for the use of a final label or ceedings prescribed in § 335.12. other final labeling that may otherwise (b) Generically approved labeling is be deemed deficient in some particular labeling which complies with the fol- may be granted by the Food Labeling lowing: Division. Temporary approvals may be (1) Labeling for a product which has granted for a period not to exceed 180 a product standard as specified in part calendar days, under the following con- 319 of this subchapter or the Standards ditions: and Labeling Policy Book and which (i) The proposed labeling would not does not contain any special claims, misrepresent the product; such as quality claims, nutrient con- (ii) The use of the labeling would not present any potential health, safety, or tent claims, health claims, negative dietary problems to the consumer; claims, geographical origin claims (ex- (iii) Denial of the request would cre- cept as provided by paragraph ate undue economic hardship; and (b)(9)(xxv) of this section), or guaran- (iv) An unfair competitive advantage tees, or which is not a domestic prod- would not result from the granting of uct labeled in a foreign language; the temporary approval. (2) Labeling for single-ingredient (2) Extensions of temporary approv- products (such as beef steak or lamb als may also be granted by the Food chops) which does not contain any spe- Labeling Division provided that the ap- cial claims, such as quality claims, nu- plicant demonstrates that new cir- trient content claims, health claims, cumstances, meeting the above cri- negative claims, geographical origin teria, have developed since the original claims (except as provided by para- temporary approval was granted. graph (b)(9)(xxv) of this section), or (g) The inspector-in-charge shall ap- guarantees, or which is not a domestic prove meat carcass ink brands and product labeled with a foreign lan- meat food product ink and burning guage; brands, which comply with parts 312 (3) Labeling for containers of prod- and 316 of this subchapter. ucts sold under contract specifications [60 FR 67454, Dec. 29, 1995] to Federal Government agencies, when such product is not offered for sale to § 317.5 Generically approved labeling. the general public, provided that the (a)(1) An official establishment or an contract specifications include specific establishment certified under a foreign requirements with respect to labeling, inspection system, in accordance with and are made available to the inspec- part 327 of this subchapter, is author- tor-in-charge; ized to use generically approved label- (4) Labeling for shipping containers ing, as defined in paragraph (b) of this which contain fully labeled immediate section, without such labeling being containers, provided such labeling submitted for approval to the Food complies with § 316.13; Safety and Inspection Service in Wash- (5) Labeling for products not in- ington or the field, provided the label- tended for human food, provided they ing is in accordance with this section comply with part 325 of this sub- and shows all mandatory features in a chapter; prominent manner as required in (6) Meat inspection legends, which § 317.2, and is not otherwise false or comply with parts 312 and 316 of this misleading in any particular. subchapter; (2) The Food Safety and Inspection (7) Inserts, tags, liners, pasters, and Service shall select samples of generi- like devices containing printed or cally approved labeling from the graphic matter and for use on, or to be records maintained by official estab- placed within containers, and coverings

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of products, provided such devices con- (ix) The addition, deletion, or amend- tain no reference to product and bear ment of recipe suggestions for the no misleading feature; product; (8) Labeling for consumer test prod- (x) Any change in punctuation; ucts not intended for sale; and (xi) Newly assigned or revised estab- (9) Labeling which was previously ap- lishment numbers for a particular es- proved by the Food Labeling Division tablishment for which use of the label- as sketch labeling, and the final labeling has been approved by the Food La- ing was prepared without modification beling Division, Regulatory Programs; or with the following modifications: (xii) The addition or deletion of open (i) All features of the labeling are dating information; proportionately enlarged or reduced, (xiii) A change in the type of pack- provided that all minimum size re- aging material on which the label is quirements specified in applicable reg- printed; ulations are met and the labeling is (xiv) Brand name changes, provided legible; that there are no design changes, the (ii) The substitution of any unit of brand name does not use a term that measurement with its abbreviation or connotes quality or other product char- the substitution of any abbreviation acteristics, the brand name has no geo- with its unit of measurement, e.g., graphic significance, and the brand ‘‘lb.’’ for ‘‘pound,’’ or ‘‘oz.’’ for name does not affect the name of the ‘‘ounce,’’ or of the word ‘‘pound’’ for product; ‘‘lb.’’ or ‘‘ounce’’ for ‘‘oz.’’; (xv) The deletion of the word ‘‘new’’ on new product labeling; (iii) A master or stock label has been approved from which the name and ad- (xvi) The addition, deletion, or dress of the distributor are omitted and amendment of special handling statements, provided that the change is con- such name and address are applied be- sistent with § 317.2(k); fore being used (in such case, the words ‘‘prepared for’’ or similar statement (xvii) The addition of safe handling instructions as required by § 317.2(l); must be shown together with the blank space reserved for the insertion of the (xviii) Changes reflecting a change in name and address when such labels are the quantity of an ingredient shown in offered for approval); the formula without a change in the order of predominance shown on the (iv) Wrappers or other covers bearing label, provided that the change in pictorial designs, emblematic designs quantity of ingredients complies with or illustrations, e.g., floral arrange- any minimum or maximum limits for ments, illustrations of animals, fire- the use of such ingredients prescribed works, etc. are used with approved la- in parts 318 and 319 of this subchapter; beling (the use of such designs will not (xix) Changes in the color of the la- make necessary the application of labeling, provided that sufficient con- beling not otherwise required); trast and legibility remain; (v) A change in the language or the (xx) A change in the product vi- arrangement of directions pertaining gnette, provided that the change does to the opening of containers or the not affect mandatory labeling informa- serving of the product; tion or misrepresent the content of the (vi) The addition, deletion, or amend- package; ment of a dated or undated coupon, a (xxi) A change in the establishment cents-off statement, cooking instruc- number by a corporation or parent tions, packer product code informa- company for an establishment under tion, or UPC product code information; its ownership; (vii) Any change in the name or ad- (xxii) Changes in nutrition labeling dress of the packer, manufacturer or that only involve quantitative adjust- distributor that appears in the signa- ments to the nutrition labeling infor- ture line; mation, except for serving sizes, pro- (viii) Any change in the net weight, vided the nutrition labeling informa- provided the size of the net weight tion maintains its accuracy and con- statement complies with § 317.2; sistency;

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(xxiii) Deletion of any claim, and the (c) That the outside container is la- deletion of non-mandatory features or beled to show that it is intended for ex- non-mandatory information; and port; but if such product is sold or of- (xxiv) The addition or deletion of a fered for sale in domestic commerce, direct translation of the English lan- all the requirements of this subchapter guage into a foreign language for prod- apply. The inspection legend and the ucts marked ‘‘for export only.’’ establishment number shall in all cases (xxv) A country of origin statement appear in English but in addition, may on any product label described in appear literally translated in a foreign § 317.8(b)(40) that complies with the re- language. quirements in that paragraph. § 317.8 False or misleading labeling or [60 FR 67455, Dec. 29, 1995, as amended at 73 practices generally; specific prohi- FR 50703, Aug. 28, 2008] bitions and requirements for labels and containers. § 317.6 Approved labels to be used only on products to which they are ap- (a) No product or any of its wrappers, plicable. packaging, or other containers shall bear any false or misleading marking, Labels shall be used only on products label, or other labeling and no state- for which they are approved, and only ment, word, picture, design, or device if they have been approved for such products in accordance with § 317.3: Pro- which conveys any false impression or vided, That existing stocks of labels ap- gives any false indication of origin or proved prior to the effective date of quality or is otherwise false or mis- this section and the quantity of which leading shall appear in any marking or has been identified to the circuit super- other labeling. No product shall be visor as being in storage on said date wholly or partly enclosed in any wrap- at the official establishment or other per, packaging, or other container that identified warehouse for the account of is so made, formed, or filled as to be the operator of the official establish- misleading. ment may be used until such stocks are (b) The labels and containers of prod- exhausted, but not later than 1 year uct shall comply with the following after the effective date of this section provisions, as applicable: unless such labels conform to all the (1) Terms having geographical sig- requirements of this part and part 319 nificance with reference to a locality of this subchapter. The Administrator other than that in which the product is may upon the show of good cause grant prepared may appear on the label only individual extension of time as he when qualified by the word ‘‘style,’’ deems necessary. ‘‘type,’’ or ‘‘brand,’’ as the case may be, in the same size and style of lettering § 317.7 Products for foreign commerce; as in the geographical term, and ac- printing labels in foreign language companied with a prominent qualifying permissible; other deviations. statement identifying the country, Labels to be affixed to packages of State, Territory, or locality in which products for foreign commerce may be the product is prepared, using terms printed in a foreign language and may appropriate to effect the qualification. show the statement of the quantity of When the word ‘‘style’’ or ‘‘type’’ is contents in accordance with the usage used, there must be a recognized style of the country to which exported and or type of product identified with and other deviations from the form of la- peculiar to the area represented by the beling required under this part may be geographical term and the product approved for such product by the Ad- must possess the characteristics of ministrator in specific cases: Provided, such style or type, and the word (a) That the proposed labeling ac- ‘‘brand’’ shall not be used in such a cords to the specifications of the for- way as to be false or misleading: Pro- eign purchaser, vided, That a geographical term which (b) That it is not in conflict with the has come into general usage as a trade laws of the country to which the prod- name and which has been approved by uct is intended for export, and the Administrator as being a generic

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term may be used without the quali- or kind of product to which they are fications provided for in this para- applied. For example, transparent or graph. The terms ‘‘frankfurter,’’ ‘‘vi- semitransparent coverings for such ar- enna,’’ ‘‘bologna,’’ ‘‘lebanon bologna,’’ ticles as sliced bacon or fresh ‘‘braunschweiger,’’ ‘‘thuringer,’’ (uncooked) meat and meat food prod- ‘‘genoa,’’ ‘‘leona,’’ ‘‘berliner,’’ ‘‘hol- ucts shall not bear lines or other de- stein,’’ ‘‘goteborg,’’ ‘‘milan,’’ ‘‘polish,’’ signs of red or other color which give a ‘‘italian,’’ and their modifications, as false impression of leanness of the applied to sausages, the terms ‘‘bruns- product. Transparent or wick’’ and ‘‘irish’’ as applied to stews semitransparent wrappers, casings, or and the term ‘‘boston’’ as applied to coverings for use in packaging cured, pork shoulder butts need not be accom- cured and smoked, or cured and cooked panied with the word ‘‘style,’’ ‘‘type,’’ sausage products, and sliced ready-to- or ‘‘brand,’’ or a statement identifying eat meat food products may be color the locality in which the product is tinted or bear red designs on 50 percent prepared. of such wrapper or covering: Provided, (2) Such terms as ‘‘farm’’ or ‘‘coun- That the transparent or try’’ shall not be used on labels in con- semitransparent portion of the prin- nection with products unless such cipal display panel is free of color tint- products are actually prepared on the ing and red designs: And provided fur- farm or in the country: Provided, That ther, That the principal display panel if the product is prepared in the same provides at least 20 percent unob- way as on the farm or in the country structed clear space, consolidated in these terms, if qualified by the word one area so that the true nature and ‘‘style’’ in the same size and style of color of the product is visible to the lettering, may be used: Provided fur- consumer. ther, That the term ‘‘farm’’ may be (ii) Packages for sliced bacon that used as part of a brand designation have a transparent opening shall be de- when qualified by the word ‘‘brand’’ in signed to expose, for viewing, the cut the same size and style of lettering, surface of a representative slice. Pack- and followed with a statement identi- ages for sliced bacon which meet the fying the locality in which the product following specifications will be accept- is prepared: And Provided further, That ed as meeting the requirements of this the provisions of this paragraph shall subparagraph provided the enclosed not apply to products prepared in ac- bacon is positioned so that the cut sur- cordance with § 319.106 of this sub- face of the representative slice can be chapter. Sausage containing cereal visually examined: shall not be labeled ‘‘farm style’’ or ‘‘country style,’’ and lard not rendered (a) For shingle-packed sliced bacon, in an open kettle shall not be des- the transparent window shall be de- ignated as ‘‘farm style’’ or ‘‘country signed to reveal at least 70 percent of style.’’ the length (longest dimension) of the (3) The requirement that the label representative slice, and this window shall contain the name and place of shall be at least 11⁄2 inches wide. The business of the manufacturer, packer, transparent window shall be located or distributor shall not relieve any es- not more than five-eighths inch from tablishment from the requirement that the top or bottom edge of a 1-pound or its label shall not be misleading in any smaller package and not more than particular. three-fourths inch from either the top (4) The term ‘‘spring lamb’’ or ‘‘gen- or bottom edge of a package larger uine spring lamb’’ is applicable only to than 1 pound. carcasses of new-crop lambs slaugh- (b) For stack-packed sliced bacon, tered during the period beginning in the transparent window shall be de- March and terminating not beyond the signed to reveal at least 70 percent of close of the week containing the first the length (longest dimension) of the Monday in October. representative slice and be at least 11⁄2 (5)(i) Coverings shall not be of such inches wide. color, design, or kind as to be mis- (6) The word ‘‘fresh’’ shall not be leading with respect to color, quality, used on labels to designate product

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which contains any sodium nitrate, so- perature of at least 160 °F. and baked dium nitrite, potassium nitrate, or po- pork cuts shall be heated to an internal tassium nitrite, or which has been salt- temperature of at least 170 °F. ed for preservation. (11) When products such as loaves are (7)(i) No ingredient shall be des- browned by dipping in hot edible oil or ignated on the label as a spice, fla- by a flame, the label shall state such voring, or coloring unless it is a spice, fact, e.g., by the words ‘‘Browned in flavoring, or coloring, as the case may Hot Cottonseed Oil’’ or ‘‘Browned by a be. An ingredient that is both a spice Flame,’’ as the case may be, appearing and a coloring, or both a flavoring and as part of the product name. a coloring, shall be designated as (12) The term ‘‘meat’’ and the names ‘‘spice and coloring’’, or ‘‘flavoring and of particular kinds of meat, such as coloring’’, as the case may be, unless beef, veal, mutton, lamb, and pork, such ingredient is designated by its shall not be used in such manner as to common or usual name. be false or misleading. (ii) Any ingredient not designated in (13) The word ‘‘ham,’’ without any § 317.2(f)(1)(i) of this part whose func- prefix indicating the species of animal tion is flavoring, either in whole or in from which derived, shall be used in la- part, must be designated by its com- beling only in connection with the hind mon or usual name. Those ingredients legs of swine. Ham shanks as such or which are of livestock and poultry ori- ham shank meat as such or the trim- gin must be designated by names that mings accruing in the trimming and include the species and livestock and shaping of hams shall not be labeled poultry tissues from which the ingredi- ‘‘ham’’ or ‘‘ham meat’’ without quali- ents are derived. fication. When used in connection with (8) As used on labels of product, the a chopped product the term ‘‘ham’’ or term ‘‘gelatin’’ shall mean (i) the jelly ‘‘ham meat’’ shall not include the skin. prepared in official establishments by (14) The terms ‘‘shankless’’ and cooking pork skins, tendons, or con- ‘‘hockless’’ shall apply only to hams nective tissue from inspected and and pork shoulders from which the passed product, and (ii) dry commercial shank or hock has been completely re- gelatin or the jelly resulting from its moved, thus eliminating the entire use. tibia and fibula, or radius and ulna, re- (9) Product (other than canned prod- spectively, together with the overlying uct) labeled with the term ‘‘loaf’’ as muscle, skin, and other tissue. part of its name: (15) Such terms as ‘‘meat extract’’ or (i) If distributed from the official es- ‘‘extract of beef’’ without qualification tablishment in consumer size con- shall not be used on labels in connec- tainers may be in any shape; tion with products prepared from or- (ii) If distributed in a container of a gans or other parts of the carcass, size larger than that sold intact at re- other than fresh meat. Extracts pre- tail the product shall be prepared in pared from any parts of the carcass rectangular form, or as in paragraph other than fresh meat may be properly (b)(9)(iii) of this section; labeled as extracts with the true name (iii) If labeled as an ‘‘Old Fashioned of the parts from which prepared. In Loaf’’ shall be prepared in a traditional the case of extract in fluid form, the form, such as rectangular with rounded word ‘‘fluid’’ shall also appear on the top or circular with flat bottom and label, as, for example, ‘‘fluid extract of rounded top. beef.’’ (10) The term ‘‘baked’’ shall apply (16) [Reserved] only to product which has been cooked (17) When any product is enclosed in by the direct action of dry heat and for a container along with a packing sub- a sufficient time to permit the product stance such as brine, vinegar, or agar to assume the characteristics of a jelly, a declaration of the packing sub- baked article, such as the formation of stance shall be printed prominently on a brown crust on the surface, rendering the label as part of the name of the out of surface fat, and the product, as for example, ‘‘frankfurts caramelization of the sugar if applied. packed in brine,’’ ‘‘lamb tongue packed Baked loaves shall be heated to a tem- in vinegar,’’ or ‘‘beef tongue packed in

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agar jelly,’’ as the case may be. The Monoglycerides,’’ or ‘‘With packing substance shall not be used in Polyglycerol Esters of Fatty Acids’’ as such a manner as will result in the con- the case may be. tainer being so filled as to be mis- (24) Section 407 of the Federal Food, leading. Drug, and Cosmetic Act contains provi- (18) ‘‘Leaf lard’’ is lard prepared from sions with respect to colored margarine fresh leaf fat. or colored oleomargarine (21 U.S.C. 347) (19) When lard or hardened lard is which are set forth herein as footnote. 1 mixed with rendered pork fat or hardened rendered pork fat, the mixture 1 ‘‘Sec. 407(a) Colored oleomargarine or col- shall be designated as ‘‘rendered pork ored margarine which is sold in the same fat’’ or ‘‘hardened rendered pork fat,’’ State or Territory in which it is produced as the case may be. shall be subject in the same manner and to (20) Oil, stearin, or stock obtained the same extent to the provisions of this Act from beef or mutton fats rendered at a as if it had been introduced in interstate ° commerce. temperature above 170 F. shall not be (b) No person shall sell, or offer for sale, designated as ‘‘oleo oil,’’ ‘‘oleo ste- colored oleomargarine or colored margarine arin,’’ or ‘‘oleo stock,’’ respectively. unless— (21) When not more than 20 percent of (1) Such oleomargarine or margarine is beef fat, mutton fat, oleo stearin, vege- packaged, table stearin, or hardened vegetable fat (2) The net weight of the contents of any is mixed with lard or with rendered package sold in a retail establishment is one pork fat, there shall appear on the pound or less, (3) There appears on the label of the pack- label, contiguous to and in the same age (A) The word ‘oleomargarine’ or ‘mar- size and style of lettering as the name garine’ in type or lettering at least as large of the product, the words ‘‘beef fat as any other type or lettering on such label, added,’’ ‘‘mutton fat added,’’ ‘‘oleo ste- and (B) A full and accurate statement of all arin added,’’ ‘‘vegetable stearin added,’’ the ingredients contained in such oleo- or ‘‘hardened vegetable fat added,’’ as margarine, or margarine, and the case may be. If more than 20 per- (4) Each part of the contents of the pack- cent is added, the product name shall age is contained in a wrapper which bears the word ‘oleomargarine’ or ‘margarine’ in refer to the particular animal fat or type or lettering not smaller than 20-point fats used, such as, ‘‘Lard and Beef type. Fat.’’ The designation ‘‘vegetable fat’’ The requirements of this subsection shall is applicable to vegetable oil, vegetable be in addition to and not in lieu of any of the stearin, or a combination of such oil other requirements of this Act. and stearin, whereas the designations (c) No person shall possess in a form ready ‘‘vegetable oil’’ and ‘‘vegetable ste- for serving colored oleomargarine or colored arin’’ shall be applicable only to the oil margarine at a public eating place unless a notice that oleomargarine or margarine is and the stearin respectively, when used served is displayed prominently and con- in meat food products. spicuously in such place and in such manner (22) Cooked, cured, or pickled pigs as to render it likely to be read and under- feet, pigs knuckles, and similar prod- stood by the ordinary individual being served ucts, shall be labeled to show that the in such eating place or is printed or is other- bones remain in the product, if such is wise set forth on the menu in type or let- the case. The designation ‘‘semi- tering not smaller than that normally used boneless’’ shall not be used if less than to designate the serving of other food items. No person shall serve colored oleomargarine 50 percent of the total weight of bones or colored margarine at a public eating has been removed. place, whether or not any charge is made (23) When monoglycerides, therefor, unless (1) each separate serving diglycerides, and/or polyglycerol esters bears or is accompanied by labeling identi- of fatty acids are added to rendered fying it as oleomargarine or margarine, or animal fat or a combination of such fat (2) each separate serving thereof is tri- and vegetable fat, there shall appear on angular in shape. the label in a prominent manner and (d) Colored oleomargarine or colored margarine when served with meals at a public contiguous to the name of the product eating place shall at the time of such service a statement such as ‘‘With be exempt from the labeling requirements of Monoglycerides and Diglycerides section 343 of this Act (except subsection (a) Added,’’ or ‘‘With Diglycerides and Continued

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(25) When approved proteolytic en- (29) Meat of goats shall be identified zymes as permitted in part 318 of this as goat meat or chevon. subchapter are used on steaks or other (30) The term ‘‘Chitterlings’’ shall raw meat cuts, there shall appear on apply to the large intestines of swine, the label, in a prominent manner, con- or young bovine animals when preceded tiguous to the product name, the state- with the word ‘‘Calf’’ or ‘‘Veal.’’ Meat ment, ‘‘Tenderized with [approved en- food products that contain chitterlings zyme],’’ to indicate the use of such en- or calf or veal chitterlings, in accord- zymes. Any other approved substance ance with § 318.6(b)(8) of this subchapter which may be used in the solution shall shall be identified with product names also be included in the statement. that refer to such ingredients, as for When approved inorganic chlorides as instance, ‘‘Chitterling Loaf,’’ permitted in part 318 of this subchapter ‘‘Chitterling Pie,’’ or ‘‘Calf Chitterlings are used on steaks or other raw meat and Gravy,’’ and shall be packed in cuts there shall appear on the label in containers having a capacity of 3 a prominent manner, contiguous to the pounds or less and of a kind usually product name, the statement, ‘‘Ten- sold at retail intact and bearing such derized with (names of approved inor- other information as is required by this ganic chloride(s))’’ to indicate the use part. of such inorganic chlorides. Any other (31) Products that contain blood from approved substance which may be in livestock as permitted by part 318 of the solution shall also be included in this subchapter shall be labeled with a the statement. name that includes the term ‘‘blood,’’ and the specific kind of blood shall be (26) When dimethylpolysiloxan is declared in the ingredient statement, added as an antifoaming agent to ren- e.g., ‘‘Swine blood,’’ in the manner re- dered fats, its presence shall be de- quired by this part. clared on the label contiguous to the (32) A calendar date may be shown on name of the product. Such declaration labeling when declared in accordance shall read ‘‘Dimethylpolysiloxan with the provisions of this subpara- Added.’’ graph: (27) When pizzas are formulated with (i) The calendar date shall express crust containing calcium propionate or the month of the year and the day of sodium propionate, there shall appear the month for all products and also the on the label contiguous to the name of year in the case of products hermeti- the product the statement ‘‘llll cally sealed in metal or glass con- added to retard spoilage of crust’’ pre- tainers, dried or frozen products, or ceded by the name of the preservative. any other products that the Adminis- (28) Sausage of the dry varieties trator finds should be labeled with the treated with potassium sorbate or year because the distribution and mar- propylparaben (propyl p-hydroxy- keting practices with respect to such benzoate) as permitted by part 318 of products may cause a label without a this subchapter, shall be marked or la- year identification to be misleading. beled with a statement disclosing such (ii) Immediately adjacent to the cal- treatment and the purpose thereof, endar date shall be a phrase explaining such as ‘‘dipped in a potassium sorbate the meaning of such date, in terms of solution to retard mold growth.’’ ‘‘packing’’ date, ‘‘sell by’’ date, or ‘‘use before’’ date, with or without a further and (f) of section 343 of this title) if it com- qualifying phrase, e.g., ‘‘For Maximum plies with the requirements of subsection (b) Freshness’’ or ‘‘For Best Quality’’, and of this section. such phrases shall be approved by the (e) For the purpose of this section colored Administrator as prescribed in § 317.4. oleomargarine or colored margarine is oleo- (33) [Reserved] margarine or margarine having a tint or (34) The terms ‘‘All,’’ ‘‘Pure,’’ shade containing more than one and six ‘‘100%,’’ and terms of similar connota- tenths degrees of yellow or of yellow and red collectively, but with an excess of yellow tion shall not be used on labels for over red, measured in terms of Lovibond products to identify ingredient con- tintometer scale or its equivalent’’ (21 U.S.C. tent, unless the product is prepared 347). solely from a single ingredient.

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(35) When agar-agar is used in canned comply with the requirements in 7 CFR jellied meat food products, as per- 65.300 and 65.400. mitted in part 318 of this subchapter, [35 FR 15580, Oct. 3, 1970] there shall appear on the label in a prominent manner, contiguous to the EDITORIAL NOTE: For FEDERAL REGISTER ci- product name, a statement to indicate tations affecting § 317.8, see the List of CFR Sections Affected, which appears in the the use of agar-agar. Finding Aids section of the printed volume (36) When sodium alginate, calcium and at www.fdsys.gov. carbonate, and lactic acid and calcium carbonate (or glucono delta-lactone) § 317.9 Labeling of equine products. are used together in a dry binding ma- The immediate containers of any trix in restructured, formed meat food equine products shall be labeled to products, as permitted in part 318 of show the kinds of animals from which this subchapter, there shall appear on derived when the products are sold, the label contiguous to the product transported, offered for sale or trans- name, a statement to indicate the use portation or received for transpor- of sodium alginate, calcium carbonate tation in commerce. and lactic acid and calcium carbonate (or glucono delta-lactone). § 317.10 Reuse of official inspection (37) The labels of sausages encased in marks; reuse of containers bearing natural casings made from meat or official marks, labels, etc. poultry viscera shall identify the type (a) No official inspection legend or of meat or poultry from which the cas- other official mark which has been pre- ings were derived, if the casings are viously used shall be used again for the from a different type of meat or poul- identification of any product, except as try than the encased meat or poultry. provided for in paragraph (b) of this The identity of the casing, if required, section. may be placed on the principal display (b) All stencils, marks, labels, or panel or in the ingredient statement. other labeling on previously used con- Establishments producing, manufac- tainers, whether relating to any prod- turing, or using natural sausage cas- uct or otherwise, shall be removed or ings are to maintain records docu- obliterated before such containers are menting the meat or poultry source in used for any product, unless such label- accordance with part 320 of this chap- ing correctly indicates the product to ter. be packed therein and such containers (38) The labels of sausages encased in are refilled under the supervision of a regenerated collagen casings shall dis- Program employee. close this fact on the product label. § 317.11 Labeling, filling of containers, The fact that the sausage is encased in handling of labeled products to be collagen may be placed on the prin- only in compliance with regula- cipal display panel or in the ingredient tions. statement. (a) No person shall in any official es- (39) When transglutaminase enzyme tablishment apply or affix, or cause to is used to bind pieces of meat to form be applied or affixed, any label to any a cut of meat, or to reform a piece of product prepared or received in such meat from a multiple cuts, there shall establishment, or to any container appear on the label, as part of the prod- thereof, or fill any container at such an uct name, a statement that indicates establishment, except in compliance that the product has been ‘‘formed’’ or with the regulations in this sub- ‘‘reformed,’’ in addition to other prepa- chapter. ration steps, e.g., ‘‘Formed Beef Ten- (b) No covering or other container derloin’’ or ‘‘Reformed and Shaped Beef shall be filled, in whole or in part, at Tenderloin.’’ any official establishment with any (40) A country of origin statement on product unless it has been inspected the label of any meat ‘‘covered com- and passed in compliance with the reg- modity’’ as defined in 7 CFR Part 65, ulations in this subchapter, is not adul- Subpart A, that is to be sold by a ‘‘re- terated, and is strictly in accordance tailer,’’ as defined in 7 CFR 65.240, must with the statements on the label, and

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such filling is done under the super- §§ 317.14–317.15 [Reserved] vision of a Program employee. (c) No person shall remove, or cause § 317.16 Labeling and containers of to be removed from an official estab- custom prepared products. lishment any product bearing a label Products that are custom prepared unless such label is in compliance with under § 303.1(a)(2) of this subchapter the regulations in this subchapter, or must be packaged immediately after any product not bearing a label re- preparation and must be labeled (in quired by such regulations. lieu of information otherwise required by this part 317) with the words ‘‘Not § 317.12 Relabeling products; require- For Sale’’ in lettering not less than ments. three-eighth inch in height. Such ex- When it is claimed by an official es- empted custom prepared products or tablishment that any of its products their containers may bear additional which bore labels bearing official labeling provided such labeling is not marks has been transported to a loca- false or misleading. tion other than an official establishment, and it is desired to relabel the [37 FR 4071, Feb. 26, 1972] product because the labels have be- § 317.17 Interpretation and statement come mutilated or otherwise damaged, of labeling policy for cured prod- a request for relabeling the product ucts; special labeling requirements shall be sent to the Administrator, ac- concerning nitrate and nitrite. companied with a statement of the rea- (a) With respect to sections 1(n) (7), sons therefor. Labeling material in- (9), and (12) of the Act and § 317.2, any tended for relabeling inspected and substance mixed with another sub- passed product shall not be transported stance to cure a product must be iden- from an official establishment until permission has been received from the tified in the ingredients statement on Administrator. The relabeling of in- the label of such product. For example, spected and passed product with labels curing mixtures composed of such in- bearing any official marks shall be gredients as water, salt, sugar, sodium done under the supervision of a Pro- phosphate, sodium nitrate, and sodium gram inspector. The official establish- nitrite or other permitted substances ment shall reimburse the Program, in which are added to any product, must accordance with the regulations of the be identified on the label of the prod- Department, for any cost involved in uct by listing each such ingredient in supervising the relabeling of such prod- accordance with the provisions of uct. § 317.2. (b) Any product, such as bacon and § 317.13 Storage and distribution of la- pepperoni, which is required to be labels and containers bearing official beled by a common or usual name or marks. descriptive name in accordance with Labels, wrappers, and containers § 317.2(c)(1) and to which nitrate or ni- bearing any official marks, with or trite is permitted or required to be without the establishment number, added may be prepared without nitrate may be transported from one official or nitrite and labeled with such com- establishment to any other official es- mon or usual name or descriptive name tablishment provided such shipments when immediately preceded with the are made with the prior authorization term ‘‘Uncured’’ as part of the product of the inspector in charge at point of name in the same size and style of let- origin, who will notify the inspector in tering as the product name, provided charge at destination concerning the that the product is found by the Ad- date of shipment, quantity, and type of ministrator to be similar in size, fla- labeling material involved. No such vor, consistency, and general appear- material shall be used at the establish- ance to such product as commonly pre- ment to which it is shipped unless such pared with nitrate or nitrite, or both. use conforms with the requirements of (c)(1) Products described in para- this subchapter. graph (b) of this section or § 319.2 of

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this subchapter, which contain no ni- the applicable conditions of use, in- trate or nitrite shall bear the state- cluding temperature limits and any ment ‘‘No Nitrate or Nitrite Added.’’ other pertinent limits specified under This statement shall be adjacent to the the FFDCA and food additive regula- product name in lettering of easily tions; and must be signed by an author- readable style and at least one-half the ized official of the supplying firm. The size of the product name. guaranty may be limited to a specific (2) Products described in paragraph shipment of an article, in which case it (b) of this section and § 319.2 of this may be part of or attached to the in- subchapter shall bear, adjacent to the voice covering such shipment, or it product name in lettering of easily may be general and continuing, in readable style and at least one-half the which case, in its application to any size of the product name, the state- article or other shipment of an article, ment ‘‘Not Preserved—Keep Refrig- it shall be considered to have been erated Below 40 °F. At All Times’’ un- given at the date such article was less they have been thermally proc- shipped by the person who gives the essed to Fo 3 or more; they have been guaranty. Guaranties consistent with fermented or pickled to pH of 4.6 or the Food and Drug Administration’s less; or they have been dried to a water regulations regarding such guaranties activity of 0.92 or less. (21 CFR 7.12 and 7.13) will be accept- (3) Products described in paragraph able. The management of the establish- (b) of this section and § 319.2 of this ment must maintain a file containing subchapter shall not be subject to the guaranties for all food contact pack- labeling requirements of paragraphs (b) aging materials in the establishment. and (c) of this section if they contain The file shall be made available to Pro- an amount of salt sufficient to achieve gram inspectors or other Department a brine concentration of 10 percent or officials upon request. While in the of- more. ficial establishment, the identity of all [37 FR 16863, Aug. 22, 1972, as amended at 44 packaging materials must be traceable FR 48961, Aug. 21, 1979] to the applicable guaranty. (c) The guaranty by the packaging §§ 317.18–317.23 [Reserved] supplier will be accepted by Program inspectors to establish that the use of § 317.24 Packaging materials. material complies with the FFDCA and (a) Edible products may not be pack- all applicable food additive regula- aged in a container which is composed tions. in whole or in part of any poisonous or (d) The Department will monitor the deleterious substances which may use of packaging material in official render the contents adulterated or in- establishments to assure that the re- jurious to health. All packaging mate- quirements of paragraph (a) of this sec- rials must be safe for their intended tion are met, and may question the use within the meaning of section 409 basis for any guaranty described under of the Federal Food, Drug, and Cos- paragraph (b) of this section. Official metic Act, as amended (FFDCA). establishments and packaging sup- (b) Packaging materials entering the pliers providing written guaranties to official establishment must be accom- those official establishments will be panied or covered by a guaranty, or permitted an opportunity to provide statement of assurance, from the pack- information tm designated Department aging supplier under whose brand name officials as needed to verify the basis and firm name the material is mar- for any such guaranty. The required in- keted to the official establishment. formation will include, but is not lim- The guaranty shall state that the ma- ited to, manufacturing firm’s name, terial’s intended use complies with the trade name or code designation for the FFDCA and all applicable food additive material, complete chemical composi- regulations. The guaranty must iden- tion, and use. Selection of a material tify the material, e.g., by the distin- for review does not in itself affect a guishing brand name or code designa- material’s acceptability. Materials tion appearing on the packaging mate- may continue to be used during the re- rial shipping container; must specify view period. However, if information

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requested from the supplier is not pro- Subpart B—Nutrition Labeling vided within the time indicated in the request—a minimum of 30 days—any SOURCE: 58 FR 664, Jan. 6, 1993, unless oth- applicable guaranty shall cease to be erwise noted. effective, and approval to continue using the specified packaging material § 317.300 Nutrition labeling of meat or in official establishments may be de- meat food products. nied. The Administrator may extend (a) Nutrition labeling shall be pro- this time where reasonable grounds for vided for all meat or meat food prod- extension are shown, as, for example, ucts intended for human consumption where data must be obtained from sup- and offered for sale, except single-in- pliers. gredient, raw products, in accordance (e) The Administrator may dis- with the requirements of § 317.309; ex- approve for use in official establish- cept as exempted under § 317.400 of this ments packaging materials whose use subpart. cannot be confirmed as complying with (b) Nutrition labeling may be pro- FFDCA and applicable food additive vided for single-ingredient, raw meat or meat food products in accordance regulations. Before approval to use a with the requirements of §§ 317.309 and packaging material is finally denied by 317.345. Significant participation in vol- the Administrator, the affected official untary nutrition labeling shall be establishment and the supplier of the measured by the Agency in accordance material shall be given notice and the with §§ 317.343 and 317.344 of this sub- opportunity to present their views to part. the Administrator. If the official establishment and the supplier do not accept [58 FR 664, Jan. 6, 1993, as amended at 60 FR 176, Jan. 3, 1995] the Administrator’s determination, a hearing in accordance with applicable EFFECTIVE DATE NOTE: At 75 FR 82164, Dec. rules of practice will be held to resolve 29, 2010, § 317.300 was revised, effective Jan. 1, 2012. At 76 FR 76890, Dec. 9, 2011, the effec- such dispute. Approval to use the ma- tiveness was delayed until Mar. 1, 2012. For terials pending the outcome of the the convenience of the user, the revised text presentation of views or hearing shall is set forth as follows: be denied if the Administrator deter- § 317.300 Nutrition labeling of meat and mines that such use may present an meat food products. imminent hazard to public health. (a) Nutrition labeling must be provided for (f) Periodically, the Administrator all meat and meat food products intended for will issue to inspectors a listing, by human consumption and offered for sale, ex- distinguishing brand name or code des- cept single-ingredient, raw meat products ignation, of packaging materials that that are not ground or chopped meat prod- have been reviewed and that fail to ucts described in § 317.301 and are not major cuts of single-ingredient, raw meat products meet the requirements of paragraph (a) identified in § 317.344, unless the product is of this section. Listed materials will exempted under § 317.400 . Nutrition labeling not be permitted for use in official es- must be provided for the major cuts of sin- tablishments. If a subsequent review of gle-ingredient, raw meat products identified any material indicates that it meets in § 317.344, either in accordance with the provisions of § 317.309 for nutrition labels, or the requirements of paragraph (a), the in accordance with the provisions of § 317.345 material will be deleted from the list- for point-of-purchase materials, except as ex- ing. empted under § 317.400. For all other products (g) Nothing in this section shall af- for which nutrition labeling is required, in- fect the authority of Program inspec- cluding ground or chopped meat products de- tors to refuse a specific material if he/ scribed in § 317.301, nutrition labeling must be provided in accordance with the provi- she determines the material may sions of § 317.309, except as exempted under render products adulterated or inju- § 317.400. rious to health. (b) Nutrition labeling may be provided for single-ingredient, raw meat products that [49 FR 2235, Jan. 19, 1984. Redesignated at 55 are not ground or chopped meat products de- FR 49833, Nov. 30, 1990] scribed in § 317.301 and that are not major cuts of single-ingredient, raw meat products

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identified in § 317.344, either in accordance the principal display panel may be con- with the provisions of § 317.309 for nutrition sidered. labels, or in accordance with the provisions of § 317.345 for point-of-purchase materials. [58 FR 664, Jan. 6, 1993, as amended at 59 FR 40213, Aug. 8, 1994; 60 FR 176, Jan. 3, 1995] § 317.301 Required nutrition labeling of ground or chopped meat prod- §§ 317.303–317.307 [Reserved] ucts. § 317.308 Labeling of meat or meat (a) Nutrition labels must be provided food products with number of for all ground or chopped products servings. (livestock species) and hamburger with The label of any package of a meat or or without added seasonings (including, meat food product that bears a rep- but not limited to, ground beef, ground resentation as to the number of beef patties, ground sirloin, ground servings contained in such package pork, and ground lamb) that are in- shall meet the requirements of tended for human consumption and of- § 317.2(h)(10). fered for sale, in accordance with the [58 FR 664, Jan. 6, 1993, as amended at 60 FR provisions of § 317.309, except as ex- 176, Jan. 3, 1995] empted under § 317.400. § 317.309 Nutrition label content. (b) [Reserved] (a) All nutrient and food component [75 FR 82165, Dec. 29, 2010] quantities shall be declared in relation EFFECTIVE DATE NOTE: At 75 FR 82165, Dec. to a serving as defined in this section. 29, 2010, § 317.301 was added, effective Jan. 1, (b)(1) The term ‘‘serving’’ or ‘‘serving 2012. At 76 FR 76890, Dec. 9, 2011, the effec- size’’ means an amount of food custom- tiveness was delayed until Mar. 1, 2012. arily consumed per eating occasion by persons 4 years of age or older, which is § 317.302 Location of nutrition infor- expressed in a common household mation. measure that is appropriate to the (a) Nutrition information on a label product. When the product is specially of a packaged meat or meat food prod- formulated or processed for use by in- uct shall appear on the label’s principal fants or by toddlers, a serving or serving size means an amount of food cus- display panel or on the information tomarily consumed per eating occasion panel, except as provided in paragraphs by infants up to 12 months of age or by (b) and (c) of this section. children 1 through 3 years of age, re- (b) Nutrition information for gift spectively. packs may be shown at a location (2) Except as provided in paragraphs other than on the product label, pro- (b)(8), (b)(12), and (b)(14) of this section vided that the labels for these products and for products that are intended for bear no nutrition claim. In lieu of on weight control and are available only the product label, nutrition informa- through a weight-control or weight- tion may be provided by alternate maintenance program, serving size de- means such as product label inserts. clared on a product label shall be deter- (c) Meat or meat food products in mined from the ‘‘Reference Amounts packages that have a total surface area Customarily Consumed Per Eating Oc- available to bear labeling greater than casion—General Food Supply’’ (Ref- 40 square inches but whose principal erence Amount(s)) that appear in display panel and information panel do § 317.312(b) using the procedures de- not provide sufficient space to accom- scribed in this paragraph (b). For prod- modate all required information may ucts that are both intended for weight use any alternate panel that can be control and available only through a readily seen by consumers for the nu- weight-control program, a manufacturer may determine the serving size trition information. In determining the that is consistent with the meal plan of sufficiency of available space for the the program. Such products must bear nutrition information, the space need- a statement, ‘‘for sale only through the ed for vignettes, designs, and other lll program’’ (fill in the blank with nonmandatory label information on the name of the appropriate weight-

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control program, e.g., Smith’s Weight than 200 percent of the Reference Control), on the principal display Amount, the manufacturer may decide panel. However, the Reference whether to declare the individual unit Amounts in § 317.312(b) shall be used for as 1 or 2 servings. purposes of evaluating whether weight- (vi) For products which consist of control products that are available two or more foods packaged and pre- only through a weight-control program sented to be consumed together where qualify for nutrition claims. the ingredient represented as the main (3) The declaration of nutrient and ingredient is in discrete units (e.g., food component content shall be on the beef fritters and barbecue sauce), the basis of the product ‘‘as packaged’’ for serving size may be the number of dis- all products, except that single-ingre- crete units represented as the main in- dient, raw products may be declared on gredient plus proportioned minor in- the basis of the product ‘‘as consumed’’ gredients used to make the Reference as set forth in § 317.345(a)(1). In addition Amount for the combined product as to the required declaration on the basis determined in § 317.312(c). of ‘‘as packaged’’ for products other (vii) For packages containing several than single-ingredient, raw products, individual single-serving containers, the declaration may also be made on each of which is labeled with all re- the basis of ‘‘as consumed,’’ provided quired information including nutrition that preparation and cooking instruc- labeling as specified in this section tions are clearly stated. (i.e., are labeled appropriately for indi- (4) For products in discrete units vidual sale as single-serving con- (e.g., hot dogs, and individually pack- tainers), the serving size shall be 1 aged products within a multi-serving unit. package), and for products which con- (5) For products in large discrete sist of two or more foods packaged and units that are usually divided for con- presented to be consumed together sumption (e.g., pizza), for unprepared where the ingredient represented as the products where the entire contents of main ingredient is in discrete units the package is used to prepare large (e.g., beef fritters and barbecue sauce), discrete units that are usually divided the serving size shall be declared as fol- for consumption (e.g. pizza kit), and for lows: products which consist of two or more (i) If a unit weighs 50 percent or less foods packaged and presented to be of the Reference Amount, the serving consumed together where the ingre- size shall be the number of whole units dient represented as the main ingre- that most closely approximates the dient is a large discrete unit usually di- Reference Amount for the product cat- vided for consumption, the serving size egory. shall be the fractional slice of the (ii) If a unit weighs more than 50 per- ready-to-eat product (e.g., 1⁄8 quiche, 1⁄4 cent but less than 67 percent of the pizza) that most closely approximates Reference Amount, the manufacturer the Reference Amount for the product may declare one unit or two units as category. The serving size may be the the serving size. fraction of the package used to make (iii) If a unit weighs 67 percent or the Reference Amount for the unpre- more but less than 200 percent of the pared product determined in § 317.312(d) Reference Amount, the serving size or the fraction of the large discrete shall be one unit. unit represented as the main ingre- (iv) If a unit weighs 200 percent or dient plus proportioned minor ingredi- more of the Reference Amount, the ents used to make the Reference manufacturer may declare one unit as Amount of the combined product deter- the serving size if the whole unit can mined in § 317.312(c). In expressing the reasonably be consumed at a single fractional slice, manufacturers shall eating occasion. use 1⁄2, 1⁄3, 1⁄4, 1⁄5, 1⁄6, or smaller fractions (v) For products that have Reference that can be generated by further divi- Amounts of 100 grams (or milliliter) or sion by 2 or 3. larger and are individual units within a (6) For nondiscrete bulk products multi-serving package, if a unit con- (e.g., whole roast beef, marinated beef tains more than 150 percent but less tenderloin, large can of chili), and for

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products which consist of two or more box, package, meal, or dinner). A de- foods packaged and presented to be scription of the individual unit shall be consumed together where the ingre- used for other products in discrete dient represented as the main ingre- units (e.g., chop, slice, link, or patty). dient is a bulk product (e.g., roast beef (v) For unprepared products where and gravy), the serving size shall be the the entire contents of the package is amount in household measure that used to prepare large discrete units most closely approximates the Ref- that are usually divided for consump- erence Amount for the product cat- tion (e.g., pizza kit), the fraction or egory and may be the amount of the portion of the package may be used. bulk product represented as the main (vi) For products that consist of two ingredient plus proportioned minor in- or more distinct ingredients or compo- gredients used to make the Reference nents packaged and presented to be Amount for the combined product de- consumed together (e.g., ham with a termined in § 317.312(c). glaze packet), the nutrition informa- (7) For labeling purposes, the term tion may be declared for each compo- ‘‘common household measure’’ or nent or as a composite. The serving ‘‘common household unit’’ means cup, size may be provided in accordance tablespoon, teaspoon, piece, slice, frac- with the provisions of paragraphs 1 tion (e.g., ⁄4 pizza), ounce (oz), or other (b)(4), (b)(5), and (b)(6) of this section. common household equipment used to (vii) For nutrition labeling purposes, package food products (e.g., jar or a teaspoon means 5 milliliters (mL), a tray). In expressing serving size in tablespoon means 15 mL, a cup means household measures, except as speci- 240 mL, and 1 oz in weight means 28 fied in paragraphs (b)(7)(iv), (v), and grams (g). (vi) of this section, the following rules shall be used: (viii) When a serving size, determined (i) Cups, tablespoons, or teaspoons from the Reference Amount in shall be used wherever possible and ap- § 317.312(b) and the procedures described in this section, falls exactly half way propriate. Cups shall be expressed in 1⁄4- between two serving sizes (e.g., 2.5 or 1⁄3-cup increments, tablespoons in whole number of tablespoons for quan- tbsp), manufacturers shall round the serving size up to the next incremental tities less than 1⁄4 cup but greater than size. or equal to 2 tablespoons (tbsp), 1, 11⁄3, 11⁄2, or 1 2⁄3 tbsp for quantities less than (8) A product that is packaged and 2 tbsp but greater than or equal to 1 sold individually and that contains less tbsp, and teaspoons in whole number of than 200 percent of the applicable Ref- teaspoons for quantities less than 1 erence Amount shall be considered to tbsp but greater than or equal to 1 tea- be a single-serving container, and the spoon (tsp), and in 1⁄4-tsp increments entire content of the product shall be for quantities less than 1 tsp. labeled as one serving, except for prod- (ii) If cups, tablespoons or teaspoons ucts that have Reference Amounts of are not applicable, units such as piece, 100 g (or mL) or larger, manufacturers slice, tray, jar, and fraction shall be may decide whether a package that used. contains more than 150 percent but less (iii) If cups, tablespoons and than 200 percent of the Reference teaspoons, or units such as piece, slice, Amount is 1 or 2 servings. Packages tray, jar, or fraction are not applicable, sold individually that contain 200 per- ounces may be used. Ounce measure- cent or more of the applicable Ref- ments shall be expressed in 0.5-ounce erence Amount may be labeled as a sin- increments most closely approxi- gle-serving if the entire content of the mating the Reference Amount with package can reasonably be consumed rounding indicated by the use of the at a single-eating occasion. term ‘‘about’’ (e.g., about 2.5 ounces). (9) A label statement regarding a (iv) A description of the individual serving shall be the serving size ex- container or package shall be used for pressed in common household measures single-serving containers and for indi- as set forth in paragraphs (b)(2) vidually packaged products within through (b)(8) of this section and shall multi-serving containers (e.g., can, be followed by the equivalent metric

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quantity in parenthesis (fluids in milli- use of the term ‘‘about’’ (e.g., about 2 liters and all other foods in grams), ex- servings; about 3.5 servings). cept for single-serving containers. (ii) When the serving size is required (i) For a single-serving container, the to be expressed on a drained solids parenthetical metric quantity, which basis and the number of servings varies will be presented as part of the net because of a natural variation in unit weight statement on the principal dis- size (e.g., pickled pigs feet), the manu- play panel, is not required except facturer may state the typical number where nutrition information is re- of servings per container (e.g., usually quired on a drained weight basis ac- 5 servings). cording to paragraph (b)(11) of this sec- (iii) For random weight products, a tion. However, if a manufacturer vol- manufacturer may declare ‘‘varied’’ for untarily provides the metric quantity the number of servings per container on products that can be sold as single- provided the nutrition information is servings, then the numerical value pro- based on the Reference Amount ex- vided as part of the serving size dec- pressed in ounces. The manufacturer laration must be identical to the met- may provide the typical number of ric quantity declaration provided as servings in parenthesis following the part of the net quantity of contents ‘‘varied’’ statement (e.g., varied (ap- statement. proximately 8 servings per pound)). (ii) The gram or milliliter quantity (iv) For packages containing several equivalent to the household measure individual single-serving containers, should be rounded to the nearest whole each of which is labeled with all re- number except for quantities that are quired information including nutrition less than 5 g (mL). The gram (mL) labeling as specified in this section quantity between 2 and 5 g (mL) should (i.e., are labeled appropriately for indi- be rounded to the nearest 0.5 g (mL) vidual sale as single-serving containers), the number of servings shall and the g (mL) quantity less than 2 g be the number of individual packages (mL) should be expressed in 0.1-g (mL) within the total package. increments. (v) For packages containing several (iii) In addition, serving size may be individually packaged multi-serving declared in ounce, in parenthesis, fol- units, the number of servings shall be lowing the metric measure separated determined by multiplying the number by a slash where other common house- of individual multi-serving units in the hold measures are used as the primary total package by the number of unit for serving size, e.g., 1 slice (28 g/ servings in each individual unit. 1 oz) for sliced bologna. The ounce (11) The declaration of nutrient and quantity equivalent to the metric food component content shall be on the quantity should be expressed in 0.1-oz basis of product as packaged or pur- increments. chased with the exception of products (iv) If a manufacturer elects to use that are packed or canned in water, abbreviations for units, the following brine, or oil but whose liquid packing abbreviations shall be used: tbsp for ta- medium is not customarily consumed. blespoon, tsp for teaspoon, g for gram, Declaration of the nutrient and food mL for milliliter, and oz for ounce. component content of products that (10) Determination of the number of are packed in liquid which is not cus- servings per container shall be based tomarily consumed shall be based on on the serving size of the product de- the drained solids. termined by following the procedures (12) The serving size for meal-type described in this section. products and main-dish products as de- (i) The number of servings shall be fined in § 317.313(l) and § 317.313(m) in rounded to the nearest whole number single-serving containers will be the except for the number of servings be- entire edible content of the package. tween 2 and 5 servings and random Serving size for meal-type products and weight products. The number of main-dish products in multi-serve con- servings between 2 and 5 servings shall tainers will be based on the reference be rounded to the nearest 0.5 serving. amount applicable to the product in Rounding should be indicated by the § 317.312(b) if the product is listed in

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§ 317.312(b). Serving size for meal-type ent names specified and in the fol- products and main-dish products in lowing order in the formats specified in multi-serve containers that are not paragraph (d) or (e) of this section. listed in § 317.312(b) will be based on the (1) ‘‘Calories, total,’’ ‘‘Total cal- reference amount according to ories,’’ or ‘‘Calories’’: A statement of § 317.312(c), (d), and (e). the caloric content per serving, ex- (13) Another column of figures may pressed to the nearest 5-calorie incre- be used to declare the nutrient and ment up to and including 50 calories, food component information in the and 10-calorie increment above 50 cal- same format as required by § 317.309(e), ories, except that amounts less than 5 (i) Per 100 grams, 100 milliliters, or 1 calories may be expressed as zero. En- ounce of the product as packaged or ergy content per serving may also be purchased. expressed in kilojoule units, added in (ii) Per one unit if the serving size of parenthesis immediately following the a product in discrete units in a multi- statement of the caloric content. serving container is more than one (i) Caloric content may be calculated unit. by the following methods. Where either (14) If a product consists of assort- specific or general food factors are ments of meat or meat food products used, the factors shall be applied to the (e.g., variety packs) in the same pack- actual amount (i.e., before rounding) of age, nutrient content shall be ex- food components (e.g., fat, carbo- pressed on the entire package contents hydrate, protein, or ingredients with or on each individual product. specific food factors) present per serv- (15) If a product is commonly coming. bined with other ingredients or is cooked or otherwise prepared before (A) Using specific Atwater factors eating, and directions for such com- (i.e., the Atwater method) given in bination or preparations are provided, Table 13, page 25, ‘‘Energy Value of another column of figures may be used Foods—Basis and Derivation,’’ by A. L. to declare the nutrient contents on the Merrill and B. K. Watt, United States basis of the product as consumed for Department of Agriculture (USDA), the product alone (e.g., a cream soup Agriculture Handbook No. 74 (Slightly mix may be labeled with one set of revised February 1973), which is incor- Daily Values for the dry mix (per serv- porated by reference. Table 13 of the ing), and another set for the serving of ‘‘Energy Value of Foods—Basis and the final soup when prepared (e.g., per Derivation,’’ Agriculture Handbook No. serving of cream soup mix and 1 cup of 74 is incorporated as it exists on the vitamin D fortified whole milk)): Pro- date of approval. This incorporation by vided, That the type and quantity of reference was approved by the Director the other ingredients to be added to of the Federal Register in accordance the product by the user and the specific with 5 U.S.C. 552(a) and 1 CFR part 51. method of cooking and other prepara- It is available for inspection at the of- tion shall be specified prominently on fice of the FSIS Docket Clerk, Room the label. 3171, South Building, 14th and Inde- (c) The declaration of nutrition infor- pendence Avenue, SW., Washington, mation on the label or in labeling of a DC, or at the National Archives and meat or meat food product shall con- Records Administration (NARA). For tain information about the level of the information on the availability of this following nutrients, except for those material at NARA, call 202–741–6030, or nutrients whose inclusion, and the dec- go to: http://www.archives.gov/ laration of amounts, is voluntary as federallregister/ set forth in this paragraph. No nutri- codeloflfederallregulations/ ents or food components other than ibrllocations.html. Copies of the incor- those listed in this paragraph as either poration by reference are available mandatory or voluntary may be in- from the Product Assessment Division, cluded within the nutrition label. Ex- Regulatory Programs, Food Safety and cept as provided for in paragraph (f) or Inspection Service, U.S. Department of (g) of this section, nutrient informa- Agriculture, Room 329, West End Court tion shall be presented using the nutri- Building, Washington, DC 20250–3700;

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(B) Using the general factors of 4, 4, increment above 50 calories, except and 9 calories per gram for protein, that amounts less than 5 calories may total carbohydrate, and total fat, re- be expressed as zero. This statement spectively, as described in USDA’s Ag- shall be indented under the statement riculture Handbook No. 74 (Slightly re- of calories from fat as provided in para- vised February 1973), pages 9–11, which graph (d)(5) of this section. is incorporated by reference. Pages 9– (2) ‘‘Fat, total’’ or ‘‘Total fat’’: A 11, Agriculture Handbook No. 74 is in- statement of the number of grams of corporated as it exists on the date of total fat per serving defined as total approval. This incorporation by ref- lipid fatty acids and expressed as erence was approved by the Director of triglycerides. Amounts shall be ex- the Federal Register in accordance pressed to the nearest 0.5 (1⁄2)-gram in- with 5 U.S.C. 552(a) and 1 CFR part 51. crement below 5 grams and to the near- (The availability of this incorporation est gram increment above 5 grams. If by reference is given in paragraph the serving contains less than 0.5 gram, (c)(1)(i)(A) of this section.); the content shall be expressed as zero. (C) Using the general factors of 4, 4, (i) ‘‘Saturated fat’’ or ‘‘Saturated’’: A and 9 calories per gram for protein, statement of the number of grams of total carbohydrate less the amount of saturated fat per serving defined as the insoluble dietary fiber, and total fat, sum of all fatty acids containing no respectively, as described in USDA’s double bonds, except that label dec- Agriculture Handbook No. 74 (Slightly laration of saturated fat content infor- revised February 1973), pages 9–11, mation is not required for products which is incorporated by reference in that contain less than 0.5 gram of total accordance with 5 U.S.C. 552(a) and 1 fat per serving if no claims are made CFR part 51. (The availability of this about fat or cholesterol content, and if incorporation by reference is given in ‘‘calories from saturated fat’’ is not de- paragraph (c)(1)(i)(A) of this section.); clared. Saturated fat content shall be or indented and expressed as grams per (D) Using data for specific food fac- serving to the nearest 0.5 (1⁄2)-gram in- tors for particular foods or ingredients crement below 5 grams and to the near- approved by the Food and Drug Admin- est gram increment above 5 grams. If istration (FDA) and provided in parts the serving contains less than 0.5 gram, 172 or 184 of 21 CFR, or by other means, the content shall be expressed as zero. as appropriate. (A) ‘‘Stearic Acid’’ (VOLUNTARY): A (ii) ‘‘Calories from fat’’: A statement statement of the number of grams of of the caloric content derived from stearic acid per serving may be de- total fat as defined in paragraph (c)(2) clared voluntarily, except that when a of this section per serving, expressed to claim is made about stearic acid, label the nearest 5-calorie increment, up to declaration shall be required. Stearic and including 50 calories, and the near- acid content shall be indented under est 10-calorie increment above 50 cal- saturated fat and expressed to the ories, except that label declaration of nearest 0.5 (1⁄2)-gram increment below 5 ‘‘calories from fat’’ is not required on grams and the nearest gram increment products that contain less than 0.5 above 5 grams. If the serving contains gram of fat per serving and amounts less than 0.5 gram, the content shall be less than 5 calories may be expressed as expressed as zero. zero. This statement shall be declared (B) [Reserved] as provided in paragraph (d)(5) of this (ii) ‘‘Polyunsaturated fat’’ or ‘‘Poly- section. unsaturated’’ (VOLUNTARY): A state- (iii) ‘‘Calories from saturated fat’’ or ment of the number of grams of poly- ‘‘Calories from saturated’’ (VOL- unsaturated fat per serving defined as UNTARY): A statement of the caloric cis,cis-methylene-interrupted poly- content derived from saturated fat as unsaturated fatty acids may be de- defined in paragraph (c)(2)(i) of this clared voluntarily, except that when section per serving may be declared monounsaturated fat is declared, or voluntarily, expressed to the nearest 5- when a claim about fatty acids or cho- calorie increment, up to and including lesterol is made on the label or in la- 50 calories, and the nearest 10-calorie beling of a product other than one that

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meets the criteria in § 317.362(b)(1) for a clared voluntarily, except that when a claim for ‘‘fat free,’’ label declaration claim is made about potassium con- of polyunsaturated fat is required. tent, label declaration shall be re- Polyunsaturated fat content shall be quired. Potassium content shall be ex- indented and expressed as grams per pressed as zero when the serving con- serving to the nearest 0.5 (1⁄2)-gram in- tains less than 5 milligrams of potas- crement below 5 grams and to the near- sium, to the nearest 5-milligram incre- est gram increment above 5 grams. If ment when the serving contains 5 to the serving contains less than 0.5 gram, 140 milligrams of potassium, and to the the content shall be expressed as zero. nearest 10-milligram increment when (iii) ‘‘Monounsaturated fat’’ or the serving contains greater than 140 ‘‘Monounsaturated’’ (VOLUNTARY): A milligrams. statement of the number of grams of (6) ‘‘Carbohydrate, total’’ or ‘‘Total monounsaturated fat per serving de- carbohydrate’’: A statement of the fined as cis-monounsaturated fatty number of grams of total carbohydrate acids may be declared voluntarily, ex- per serving expressed to the nearest cept that when polyunsaturated fat is gram, except that if a serving contains declared, or when a claim about fatty less than 1 gram, the statement ‘‘Con- acids or cholesterol is made on the tains less than 1 gram’’ or ‘‘less than 1 label or in labeling of a product other gram’’ may be used as an alternative, than one that meets the criteria in or, if the serving contains less than 0.5 § 317.362(b)(1) for a claim for ‘‘fat free,’’ gram, the content may be expressed as label declaration of monounsaturated zero. Total carbohydrate content shall fat is required. Monounsaturated fat be calculated by subtraction of the sum content shall be indented and expressed of the crude protein, total fat, mois- as grams per serving to the nearest 0.5 ture, and ash from the total weight of (1⁄2)-gram increment below 5 grams and the product. This calculation method is to the nearest gram increment above 5 described in USDA’s Agriculture Hand- grams. If the serving contains less than book No. 74 (Slightly revised February 0.5 gram, the content shall be expressed 1973), pages 2 and 3, which is incor- as zero. porated by reference. Pages 2 and 3, Ag- (3) ‘‘Cholesterol’’: A statement of the riculture Handbook No. 74 is incor- cholesterol content per serving ex- porated as it exists on the date of ap- pressed in milligrams to the nearest 5- proval. This incorporation by reference milligram increment, except that label was approved by the Director of the declaration of cholesterol information Federal Register in accordance with 5 is not required for products that con- U.S.C. 552(a) and 1 CFR part 51. (The tain less than 2 milligrams of choles- availability of this incorporation by terol per serving and make no claim reference is given in paragraph about fat, fatty acids, or cholesterol (c)(1)(i)(A) of this section.) content, or such products may state (i) ‘‘Dietary fiber’’: A statement of the cholesterol content as zero. If the the number of grams of total dietary product contains 2 to 5 milligrams of fiber per serving, indented and ex- cholesterol per serving, the content pressed to the nearest gram, except may be stated as ‘‘less than 5 milli- that if a serving contains less than 1 grams.’’ gram, declaration of dietary fiber is (4) ‘‘Sodium’’: A statement of the not required, or, alternatively, the number of milligrams of sodium per statement ‘‘Contains less than 1 gram’’ serving expressed as zero when the or ‘‘less than 1 gram’’ may be used, and serving contains less than 5 milligrams if the serving contains less than 0.5 of sodium, to the nearest 5-milligram gram, the content may be expressed as increment when the serving contains 5 zero. to 140 milligrams of sodium, and to the (A) ‘‘Soluble fiber’’ (VOLUNTARY): nearest 10-milligram increment when A statement of the number of grams of the serving contains greater than 140 soluble dietary fiber per serving may milligrams. be declared voluntarily except when a (5) ‘‘Potassium’’ (VOLUNTARY): A claim is made on the label or in label- statement of the number of milligrams ing about soluble fiber, label declara- of potassium per serving may be de- tion shall be required. Soluble fiber

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content shall be indented under dietary ognized as safe (e.g., sorbitol). In lieu fiber and expressed to the nearest of the term ‘‘sugar alcohol,’’ the name gram, except that if a serving contains of the specific sugar alcohol (e.g., less than 1 gram, the statement ‘‘Con- ‘‘xylitol’’) present in the product may tains less than 1 gram’’ or ‘‘less than 1 be used in the nutrition label, provided gram’’ may be used as an alternative, that only one sugar alcohol is present and if the serving contains less than 0.5 in the product. Sugar alcohol content gram, the content may be expressed as shall be indented and expressed to the zero. nearest gram, except that if a serving (B) ‘‘Insoluble fiber’’ (VOLUNTARY): contains less than 1 gram, the state- A statement of the number of grams of ment ‘‘Contains less then 1 gram’’ or insoluble dietary fiber per serving may ‘‘less than 1 gram’’ may be used as an be declared voluntarily except when a alternative, and if the serving contains claim is made on the label or in label- less than 0.5 gram, the content may be ing about insoluble fiber, label declara- expressed as zero. tion shall be required. Insoluble fiber (iv) ‘‘Other carbohydrate’’ (VOL- content shall be indented under dietary UNTARY): A statement of the number fiber and expressed to the nearest of grams of other carbohydrate per gram, except that if a serving contains serving may be declared voluntarily. less than 1 gram, the statement ‘‘Con- Other carbohydrate shall be defined as tains less than 1 gram’’ or ‘‘less than 1 the difference between total carbo- gram’’ may be used as an alternative, hydrate and the sum of dietary fiber, and if the serving contains less than 0.5 sugars, and sugar alcohol, except that gram, the content may be expressed as if sugar alcohol is not declared (even if zero. present), it shall be defined as the dif- (ii) ‘‘Sugars’’: A statement of the ference between total carbohydrate and number of grams of sugars per serving, the sum of dietary fiber and sugars. except that label declaration of sugars Other carbohydrate content shall be in- content is not required for products dented and expressed to the nearest that contain less than 1 gram of sugars gram, except that if a serving contains per serving if no claims are made about less than 1 gram, the statement ‘‘Con- sweeteners, sugars, or sugar alcohol tains less than 1 gram’’ or ‘‘less than 1 content. Sugars shall be defined as the gram’’ may be used as an alternative, sum of all free mono- and disaccharides and if the serving contains less than 0.5 (such as glucose, fructose, lactose, and gram, the content may be expressed as sucrose). Sugars content shall be in- zero. dented and expressed to the nearest (7) ‘‘Protein’’: A statement of the gram, except that if a serving contains number of grams of protein per serving less than 1 gram, the statement ‘‘Con- expressed to the nearest gram, except tains less than 1 gram’’ or ‘‘less than 1 that if a serving contains less than 1 gram’’ may be used as an alternative, gram, the statement ‘‘Contains less and if the serving contains less than 0.5 than 1 gram’’ or ‘‘less than 1 gram’’ gram, the content may be expressed as may be used as an alternative, and if zero. the serving contains less than 0.5 gram, (iii) ‘‘Sugar alcohol’’ (VOLUNTARY): the content may be expressed as zero. A statement of the number of grams of When the protein in products rep- sugar alcohols per serving may be de- resented or purported to be for adults clared voluntarily on the label, except and children 4 or more years of age has that when a claim is made on the label a protein quality value that is a pro- or in labeling about sugar alcohol or tein digestibility-corrected amino acid sugars when sugar alcohols are present score of less than 20 expressed as a per- in the product, sugar alcohol content cent, or when the protein in a product shall be declared. For nutrition label- represented or purported to be for chil- ing purposes, sugar alcohols are defined dren greater than 1 but less than 4 as the sum of saccharide derivatives in years of age has a protein quality value which a hydroxyl group replaces a ke- that is a protein digestibility-corrected tone or aldehyde group and whose use amino acid score of less than 40 ex- in the food is listed by FDA (e.g., pressed as a percent, either of the fol- mannitol or xylitol) or is generally rec- lowing shall be placed adjacent to the

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declaration of protein content by above 1.00, then it shall be set at 1.00. weight: The statement ‘‘not a signifi- The protein digestibility-corrected cant source of protein,’’ or a listing amino acid score shall be determined aligned under the column headed by methods given in sections 5.4.1, 7.2.1, ‘‘Percent Daily Value’’ of the corrected and 8 in ‘‘Protein Quality Evaluation, amount of protein per serving, as de- Report of the Joint FAO/WHO Expert termined in paragraph (c)(7)(ii) of this Consultation on Protein Quality Eval- section, calculated as a percentage of uation,’’ Rome, 1990, which is incor- the Daily Reference Value (DRV) or porated by reference. Sections 5.4.1, Reference Daily Intake (RDI), as appro- 7.2.1, and 8 of the ‘‘Report of the Joint priate, for protein and expressed as per- FAO/WHO Expert Consultation on Pro- cent of Daily Value. When the protein tein Quality Evaluation,’’ as published quality in a product as measured by by the Food and Agriculture Organiza- the Protein Efficiency Ratio (PER) is tion of the United Nations/World less than 40 percent of the reference Health Organization, is incorporated as standard (casein) for a product rep- it exists on the date of approval. This resented or purported to be for infants, incorporation by reference was ap- the statement ‘‘not a significant source proved by the Director of the Federal of protein’’ shall be placed adjacent to Register in accordance with 5 U.S.C. the declaration of protein content. Pro- 552(a) and 1 CFR part 51. It is available tein content may be calculated on the for inspection at the office of the FSIS basis of the factor of 6.25 times the ni- Docket Clerk, Room 3171, South Build- trogen content of the food as deter- ing, 14th and Independence Avenue, mined by appropriate methods of anal- SW., Washington, DC, or at the Na- ysis in accordance with § 317.309(h), ex- tional Archives and Records Adminis- cept when the procedure for a specific tration (NARA). For information on food requires another factor. (i) A statement of the corrected the availability of this material at amount of protein per serving, as de- NARA, call 202–741–6030, or go to: http:// termined in paragraph (c)(7)(ii) of this www.archives.gov/federallregister/ section, calculated as a percentage of codeloflfederallregulations/ the RDI or DRV for protein, as appro- ibrllocations.html. Copies of the incor- priate, and expressed as percent of poration by reference are available Daily Value, may be placed on the from the Product Assessment Division, label, except that such a statement Regulatory Programs, Food Safety and shall be given if a protein claim is Inspection Service, U.S. Department of made for the product, or if the product Agriculture, Room 329, West End Court is represented or purported to be for in- Building, Washington, DC 20250–3700. fants or children under 4 years of age. For products represented or purported When such a declaration is provided, it to be for infants, the corrected amount shall be placed on the label adjacent to of protein (grams) per serving is equal the statement of grams of protein and to the actual amount of protein aligned under the column headed (grams) per serving multiplied by the ‘‘Percent Daily Value,’’ and expressed relative protein quality value. The rel- to the nearest whole percent. However, ative protein quality value shall be de- the percentage of the RDI for protein termined by dividing the subject prod- shall not be declared if the product is uct’s protein PER value by the PER represented or purported to be for in- value for casein. If the relative protein fants and the protein quality value is value is above 1.00, it shall be set at less than 40 percent of the reference 1.00. standard. (iii) For the purpose of labeling with (ii) The corrected amount of protein a percent of the DRV or RDI, a value of (grams) per serving for products rep- 50 grams of protein shall be the DRV resented or purported to be for adults for adults and children 4 or more years and children 1 or more years of age is of age, and the RDI for protein for chil- equal to the actual amount of protein dren less than 4 years of age, infants, (grams) per serving multiplied by the pregnant women, and lactating women amino acid score corrected for protein shall be 16 grams, 14 grams, 60 grams, digestibility. If the corrected score is and 65 grams, respectively.

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(8) Vitamins and minerals: A state- declaration may also include any of the ment of the amount per serving of the other vitamins and minerals listed in vitamins and minerals as described in paragraph (c)(8)(iv) of this section this paragraph, calculated as a percent when they are naturally occurring in of the RDI and expressed as percent of the food. The additional vitamins and Daily Value. minerals shall be listed in the order es- (i) For purposes of declaration of per- tablished in paragraph (c)(8)(iv) of this cent of Daily Value as provided for in section. paragraphs (d) through (g) of this sec- (iii) The percentages for vitamins tion, products represented or purported and minerals shall be expressed to the to be for use by infants, children less nearest 2-percent increment up to and than 4 years of age, pregnant women, including the 10-percent level, the or lactating women shall use the RDI’s nearest 5-percent increment above 10 that are specified for the intended percent and up to and including the 50- group. For products represented or pur- percent level, and the nearest 10-per- ported to be for use by both infants and cent increment above the 50-percent children under 4 years of age, the per- level. Amounts of vitamins and min- cent of Daily Value shall be presented erals present at less than 2 percent of by separate declarations according to the RDI are not required to be declared paragraph (e) of this section based on in nutrition labeling but may be de- the RDI values for infants from birth clared by a zero or by the use of an as- to 12 months of age and for children terisk (or other symbol) that refers to under 4 years of age. Similarly, the another asterisk (or symbol) that is percent of Daily Value based on both placed at the bottom of the table and the RDI values for pregnant women that is followed by the statement and for lactating women shall be de- ‘‘Contains less than 2 percent of the clared separately on products rep- Daily Value of this (these) nutrient resented or purported to be for use by (nutrients).’’ Alternatively, if vitamin both pregnant and lactating women. A, vitamin C, calcium, or iron is When such dual declaration is used on present in amounts less than 2 percent any label, it shall be included in all la- of the RDI, label declaration of the nu- beling, and equal prominence shall be trient(s) is not required if the state- given to both values in all such label- ment ‘‘Not a significant source of ing. All other products shall use the lll (listing the vitamins or minerals RDI for adults and children 4 or more omitted)’’ is placed at the bottom of years of age. the table of nutrient values. (ii) The declaration of vitamins and (iv) The following RDI’s and nomen- minerals as a percent of the RDI shall clature are established for the fol- include vitamin A, vitamin C, calcium, lowing vitamins and minerals which and iron, in that order, and shall in- are essential in human nutrition: clude any of the other vitamins and minerals listed in paragraph (c)(8)(iv) Vitamin A, 5,000 International Units of this section when they are added, or Vitamin C, 60 milligrams when a claim is made about them. Calcium, 1.0 gram Other vitamins and minerals need not Iron, 18 milligrams be declared if neither the nutrient nor Vitamin D, 400 International Units Vitamin E, 30 International Units the component is otherwise referred to Thiamin, 1.5 milligrams on the label or in labeling or adver- Riboflavin, 1.7 milligrams tising and the vitamins and minerals Niacin, 20 milligrams are: Vitamin B6, 2.0 milligrams (A) Required or permitted in a stand- Folate, 0.4 milligram ardized food (e.g., thiamin, riboflavin, Vitamin B12, 6 micrograms and niacin in enriched flour) and that Biotin, 0.3 milligram standardized food is included as an in- Pantothenic acid, 10 milligrams gredient (i.e., component) in another Phosphorus, 1.0 gram product; or Iodine, 150 micrograms (B) Included in a product solely for Magnesium, 400 milligrams technological purposes and declared Zinc, 15 milligrams only in the ingredients statement. The Copper, 2.0 milligrams

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(v) The following synonyms may be inches as provided for in paragraph (g) added in parenthesis immediately fol- of this section. lowing the name of the nutrient or die- (i) The nutrition information shall be tary component: set off in a box by use of hairlines and Vitamin C—Ascorbic acid shall be all black or one color type, Thiamin—Vitamin B printed on a white or other neutral 1 contrasting background whenever prac- Riboflavin—Vitamin B2 Folate—Folacin tical. Calories—Energy (ii) All information within the nutrition label shall utilize: (vi) A statement of the percent of vi- (A) A single easy-to-read type style, tamin A that is present as beta-carotene may be declared voluntarily. (B) Upper and lower case letters, When the vitamins and minerals are (C) At least one point leading (i.e., listed in a single column, the state- space between two lines of text) except ment shall be indented under the infor- that at least four points leading shall mation on vitamin A. When vitamins be utilized for the information required and minerals are arrayed horizontally, by paragraphs (d)(7) and (d)(8) of this the statement of percent shall be pre- section, and sented in parenthesis following the dec- (D) Letters should never touch. laration of vitamin A and the percent (iii) Information required in para- of Daily Value of vitamin A in the graphs (d)(3), (d)(5), (d)(7), and (d)(8) of product (e.g., ‘‘Percent Daily Value: this section shall be in type size no Vitamin A 50 (90 percent as beta-caro- smaller than 8 point. Except for the tene)’’). When declared, the percent- heading ‘‘Nutrition Facts,’’ the infor- ages shall be expressed in the same in- mation required in paragraphs (d)(4), crements as are provided for vitamins (d)(6), and (d)(9) of this section and all and minerals in paragraph (c)(8)(iii) of other information contained within the this section. nutrition label shall be in type size no (9) For the purpose of labeling with a smaller than 6 point. When provided, percent of the DRV, the following the information described in paragraph DRV’s are established for the following (d)(10) of this section shall also be in food components based on the reference type no smaller than 6 point. caloric intake of 2,000 calories: (iv) The headings required by paragraphs (d)(2), (d)(4), and (d)(6) of this Food component Unit of measurement DRV section (i.e., ‘‘Nutrition Facts,’’ Fat ...... grams (g) ...... 65 ‘‘Amount per Serving,’’ and ‘‘% Daily Saturated fatty acids ...... do ...... 20 Value*’’), the names of all nutrients Cholesterol ...... milligrams (mg) ...... 300 that are not indented according to re- Total carbohydrate ...... grams (g) ...... 300 quirements of paragraph (c) of this sec- Fiber ...... do ...... 25 tion (i.e., Calories, Total fat, Choles- Sodium ...... milligrams (mg) ...... 2,400 Potassium ...... do ...... 3,500 terol, Sodium, Potassium, Total carbo- Protein ...... grams (g) ...... 50 hydrate, and Protein), and the percentage amounts required by paragraph (d)(1) Nutrient information specified (d)(7)(ii) of this section shall be high- in paragraph (c) of this section shall be lighted by bold or extra bold type or presented on products in the following other highlighting (reverse printing is format, except on products on which not permitted as a form of high- dual columns of nutrition information lighting) that prominently distin- are declared as provided for in para- guishes it from other information. No graph (e) of this section, on those prod- other information shall be highlighted. ucts on which the simplified format is (v) A hairline rule that is centered permitted to be used as provided for in between the lines of text shall separate paragraph (f) of this section, on prod- ‘‘Amount Per Serving’’ from the cal- ucts for infants and children less than orie statements required in paragraph 4 years of age as provided for in (d)(5) of this section and shall separate § 317.400(c), and on products in packages each nutrient and its corresponding that have a total surface area available percent of Daily Value required in to bear labeling of 40 or less square paragraphs (d)(7)(i) and (d)(7)(ii) of this

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section from the nutrient and percent tamins and minerals, shall be declared of Daily Value above and below it. as follows: (2) The information shall be pre- (i) The name of each nutrient, as sented under the identifying heading of specified in paragraph (c) of this sec- ‘‘Nutrition Facts’’ which shall be set in tion, shall be given in a column and a type size larger than all other print followed immediately by the quan- size in the nutrition label and, except titative amount by weight for that nu- for labels presented according to the trient appended with a ‘‘g’’ for grams format provided for in paragraph (d)(11) or ‘‘mg’’ for milligrams. of this section, unless impractical, (ii) A listing of the percent of the shall be set the full width of the infor- DRV as established in paragraphs mation provided under paragraph (d)(7) (c)(7)(iii) and (c)(9) of this section shall of this section. be given in a column aligned under the (3) Information on serving size shall heading ‘‘% Daily Value’’ established immediately follow the heading. Such in paragraph (d)(6) of this section with information shall include: the percent expressed to the nearest (i) ‘‘Serving Size’’: A statement of whole percent for each nutrient de- the serving size as specified in para- clared in the column described in paragraph (b)(9) of this section. graph (d)(7)(i) of this section for which (ii) ‘‘Servings Per Container’’: The a DRV has been established, except number of servings per container, ex- that the percent for protein may be cept that this statement is not re- omitted as provided in paragraph (c)(7) quired on single-serving containers as of this section. The percent shall be defined in paragraph (b)(8) of this sec- calculated by dividing either the tion. amount declared on the label for each (4) A subheading ‘‘Amount Per Serv- nutrient or the actual amount of each ing’’ shall be separated from serving nutrient (i.e., before rounding) by the size information by a bar. DRV for the nutrient, except that the (5) Information on calories shall im- percent for protein shall be calculated mediately follow the heading ‘‘Amount as specified in paragraph (c)(7)(ii) of Per Serving’’ and shall be declared in this section. The numerical value shall one line, leaving sufficient space be- be followed by the symbol for percent tween the declaration of ‘‘Calories’’ (i.e., %). and ‘‘Calories from fat’’ to allow clear (8) Nutrient information for vitamins differentiation, or, if ‘‘Calories from and minerals shall be separated from saturated fat’’ is declared, in a column information on other nutrients by a with total ‘‘Calories’’ at the top, fol- bar and shall be arrayed horizontally lowed by ‘‘Calories from fat’’ (in- (e.g., Vitamin A 4%, Vitamin C 2%, dented), and ‘‘Calories from saturated Calcium 15%, Iron 4%) or may be listed fat’’ (indented). in two columns, except that when more (6) The column heading ‘‘% Daily than four vitamins and minerals are Value,’’ followed by an asterisk (e.g., declared, they may be declared ‘‘% Daily Value*’’), shall be separated vertically with percentages listed from information on calories by a bar. under the column headed ‘‘% Daily The position of this column heading Value.’’ shall allow for a list of nutrient names (9) A footnote, preceded by an aster- and amounts as described in paragraph isk, shall be placed beneath the list of (d)(7) of this section to be to the left of, vitamins and minerals and shall be sep- and below, this column heading. The arated from that list by a hairline. column headings ‘‘Percent Daily (i) The footnote shall state: Percent Value,’’ ‘‘Percent DV,’’ or ‘‘% DV’’ may Daily Values are based on a 2,000 cal- be substituted for ‘‘% Daily Value.’’ orie diet. Your daily values may be (7) Except as provided for in para- higher or lower depending on your cal- graph (g) of this section, and except as orie needs. permitted by § 317.400(d)(2), nutrient in- Calories: 2,000 2,500 formation for both mandatory and any voluntary nutrients listed in paragraph Total fat ...... Less than .. 65 g ...... 80 g Saturated fat ...... Less than .. 20 g ...... 25 g (c) of this section that are to be de- Cholesterol ...... Less than .. 300 mg ..... 300 mg clared in the nutrition label, except vi- Sodium ...... Less than .. 2,400 mg .. 2,400 mg

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Calories: 2,000 2,500 off by a line that distinguishes it and sets it apart from the percent of Daily Total carbohydrate ...... 300 g ...... 375 g Dietary fiber ...... 25 g ...... 30 g Value information. The caloric conversion information provided for in para- (ii) If the percent of Daily Value is graph (d)(10) of this section may be pre- given for protein in the Percent of sented beneath either side or along the Daily Value column as provided in full length of the nutrition label. paragraph (d)(7)(ii) of this section, pro- (ii) If the space beneath the manda- tein shall be listed under dietary fiber, tory declaration of iron is not adequate and a value of 50 g shall be inserted on to accommodate any remaining vita- the same line in the column headed mins and minerals to be declared or the ‘‘2,000’’ and value of 65 g in the column information required in paragraph headed ‘‘2,500.’’ (d)(9) of this section, the remaining in- (iii) If potassium is declared in the formation may be moved to the right column described in paragraph (d)(7)(i) and set off by a line that distinguishes of this section, potassium shall be list- it and sets it apart from the percent of ed under sodium and the DRV estab- Daily Value information given to the lished in paragraph (c)(9) of this sec- left. The caloric conversion information shall be inserted on the same line tion provided for in paragraph (d)(10) of in the numeric columns. this section may be presented beneath (iv) The abbreviations established in either side or along the full length of paragraph (g)(2) of this section may be the nutrition label. used within the footnote. (10) Caloric conversion information (iii) If there is not sufficient contin- on a per-gram basis for fat, carbo- uous vertical space (i.e., approximately hydrate, and protein may be presented 3 inches) to accommodate the required beneath the information required in components of the nutrition label up to paragraph (d)(9), separated from that and including the mandatory declara- information by a hairline. This infor- tion of iron, the nutrition label may be mation may be presented horizontally presented in a tabular display in which (i.e., ‘‘Calories per gram: Fat 9, Carbo- the footnote required by paragraph hydrate 4, Protein 4’’) or vertically in (d)(9) of the section is given to the far columns. right of the label, and additional vita- (11)(i) If the space beneath the infor- mins and minerals beyond the four mation on vitamins and minerals is not that are required (i.e., vitamin A, vita- adequate to accommodate the informa- min C, calcium, and iron) are arrayed tion required in paragraph (d)(9) of this horizontally following declarations of section, the information required in the required vitamins and minerals. paragraph (d)(9) may be moved to the (12) The following sample label illus- right of the column required in para- trates the provisions of paragraph (d) graph (d)(7)(ii) of this section and set of this section:

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(13)(i) Nutrition labeling on the outer used interchangeably for the same type label of packages of meat or meat food of food (e.g., meat salad containers) products that contain two or more may use an aggregate display. products in the same packages (e.g., (ii) Aggregate displays shall comply variety packs) or of packages that are with format requirements of paragraph

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(d) of this section to the maximum ex- (d)(5) of this section with quantitative tent possible, except that the identity amounts declared in columns aligned of each food shall be specified to the under the column headings set forth in right of the ‘‘Nutrition Facts’’ title, paragraph (e)(1) of this section. and both the quantitative amount by (3) Quantitative information by weight (i.e., g/mg amounts) and the weight required in paragraph (d)(7)(i) of percent Daily Value for each nutrient this section shall be specified for the shall be listed in separate columns form of the product as packaged and under the name of each food. according to the label serving size (14) When nutrition labeling appears based on the Reference Amount in in a second language, the nutrition in- § 317.312(b). formation may be presented in a sepa- (i) Quantitative information by rate nutrition label for each language weight may be included for other forms or in one nutrition label with the infor- of the product represented by the addi- mation in the second language fol- tional column(s) either immediately lowing that in English. Numeric char- adjacent to the required quantitative acters that are identical in both lan- information by weight for the product guages need not be repeated (e.g., as packaged and according to the label ‘‘Protein/Proteinas 2 g’’). All required serving size based on the Reference information must be included in both Amount in § 317.312(b) or as a footnote. languages. (A) If such additional quantitative (e) Nutrition information may be pre- information is given immediately adja- sented for two or more forms of the cent to the required quantitative infor- same product (e.g., both ‘‘raw’’ and mation, it shall be declared for all nu- ‘‘cooked’’) or for common combina- trients listed and placed immediately tions of foods as provided for in para- following and differentiated from the graph (b) of this section, or for dif- required quantitative information ferent units (e.g., per 100 grams) as pro- (e.g., separated by a comma). Such in- vided for in paragraph (b) of this sec- formation shall not be put in a sepa- tion, or for two or more groups for which RDI’s are established (e.g., both rate column. infants and children less than 4 years (B) If such additional quantitative in- of age) as provided for in paragraph formation is given in a footnote, it (c)(8)(i) of this section. When such dual shall be declared in the same order as labeling is provided, equal prominence the nutrients are listed in the nutri- shall be given to both sets of values. tion label. The additional quantitative Information shall be presented in a for- information may state the total nutri- mat consistent with paragraph (d) of ent content of the product identified in this section, except that: the second column or the nutrient (1) Following the subheading of amounts added to the product as pack- ‘‘Amount Per Serving,’’ there shall be aged for only those nutrients that are two or more column headings accu- present in different amounts than the rately describing the forms of the same amounts declared in the required quan- product (e.g., ‘‘raw’’ and ‘‘roasted’’), titative information. The footnote the combinations of foods, the units, or shall clearly identify which amounts the RDI groups that are being declared. are declared. Any subcomponents de- The column representing the product clared shall be listed parenthetically as packaged and according to the label after principal components (e.g., 1⁄2 cup serving size based on the Reference skim milk contributes an additional 40 Amount in § 317.312(b) shall be to the calories, 65 mg sodium, 6 g total carbo- left of the numeric columns. hydrate (6 g sugars), and 4 g protein). (2) When the dual labeling is pre- (ii) Total fat and its quantitative sented for two or more forms of the amount by weight shall be followed by same product, for combinations of an asterisk (or other symbol) (e.g., foods, or for different units, total cal- ‘‘Total fat (2 g)*’’) referring to another ories and calories from fat (and cal- asterisk (or symbol) at the bottom of ories from saturated fat, when de- the nutrition label identifying the clared) shall be listed in a column and form(s) of the product for which quan- indented as specified in paragraph titative information is presented.

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(4) Information required in para- headings set forth in paragraph (e)(1) of graphs (d)(7)(ii) and (d)(8) of this sec- this section. tion shall be presented under the sub- (5) The following sample label illus- heading ‘‘% DAILY VALUE’’ and in trates the provisions of paragraph (e) columns directly under the column of this section:

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(f)(1) Nutrition information may be forth herein when any required nutri- presented in a simplified format as set ents, other than the core nutrients

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(i.e., calories, total fat, sodium, total are based on a 2,000 calorie diet’’ and, if carbohydrate, and protein), are present the term ‘‘Daily Value’’ is not spelled in insignificant amounts. An insignifi- out in the heading, a statement that cant amount shall be defined as that ‘‘DV’’ represents ‘‘Daily Value.’’ amount that may be rounded to zero in (g) Foods in packages that have a nutrition labeling, except that for total total surface area available to bear la- carbohydrate, dietary fiber, sugars and beling of 40 or less square inches may protein, it shall be an amount less than modify the requirements of paragraphs 1 gram. (c) through (f) of this section and (2) The simplified format shall in- § 317.302(a) by one or more of the fol- clude information on the following nu- lowing means: trients: (1)(i) Presenting the required nutri- (i) Total calories, total fat, total car- tion information in a tabular or linear bohydrate, sodium, and protein; (i.e., string) fashion, rather than in (ii) Any of the following that are vertical columns if the product has a present in more than insignificant total surface area available to bear la- amounts: Calories from fat, saturated beling of less than 12 square inches, or fat, cholesterol, dietary fiber, sugars, if the product has a total surface area vitamin A, vitamin C, calcium, and available to bear labeling of 40 or less iron; and square inches and the package shape or (iii) Any vitamins and minerals list- size cannot accommodate a standard ed in paragraph (c)(8)(iv) of this section vertical column or tabular display on when they are added in fortified or fab- any label panel. Nutrition information ricated foods. may be given in a linear fashion only if (3) Other nutrients that are naturally the package shape or size will not ac- present in the product in more than in- commodate a tabular display. significant amounts may be volun- (ii) When nutrition information is tarily declared as part of the simplified given in a linear display, the nutrition format. information shall be set off in a box by (4) Any required nutrient, other than the use of a hairline. The percent Daily a core nutrient, that is present in an Value is separated from the quan- insignificant amount may be omitted titative amount declaration by the use from the tabular listing, provided that of parenthesis, and all nutrients, both the following statement is included at principal components and subcompo- the bottom of the nutrition label, ‘‘Not nents, are treated similarly. Bolding is a significant source of llll.’’ The required only on the title ‘‘Nutrition blank shall be filled in with the appro- Facts’’ and is allowed for nutrient priate nutrient or food component. Al- names for ‘‘Calories,’’ ‘‘Total fat,’’ ternatively, amounts of vitamins and ‘‘Cholesterol,’’ ‘‘Sodium,’’ ‘‘Total car- minerals present in insignificant bohydrate,’’ and ‘‘Protein.’’ amounts may be declared by the use of (2) Using any of the following abbre- an asterisk (or symbol) that is placed viations: at the bottom of the table of nutrient Serving size—Serv size values and that is followed by the Servings per container—Servings statement ‘‘Contains less than 2 per- Calories from fat—Fat cal cent of the Daily Value of this (these) Calories from saturated fat—Sat fat cal nutrient (nutrients).’’ Saturated fat—Sat fat (5) Except as provided for in para- Monounsaturated fat—Monounsat fat Polyunsaturated fat—Polyunsat fat graph (g) of this section and in Cholesterol—Cholest § 317.400(c) and (d), nutrient informa- Total carbohydrate—Total carb tion declared in the simplified format Dietary fiber—Fiber shall be presented in the same manner Soluble fiber—Sol fiber as specified in paragraphs (d) or (e) of Insoluble fiber—Insol fiber this section, except that the footnote Sugar alcohol—Sugar alc required in paragraph (d)(9) of this sec- Other carbohydrate—Other carb tion is not required. When the footnote (3) Omitting the footnote required in is omitted, an asterisk shall be placed paragraph (d)(9) of this section and at the bottom of the label followed by placing another asterisk at the bottom the statement ‘‘Percent Daily Values of the label followed by the statement

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‘‘Percent Daily Values are based on a Copies may be purchased from the 2,000 calorie diet’’ and, if the term AOAC International, 2200 Wilson Blvd., ‘‘Daily Value’’ is not spelled out in the suite 400, Arlington, VA 22201. It is also heading, a statement that ‘‘DV’’ rep- available for inspection at the National resents ‘‘Daily Value.’’ Archives and Records Administration (4) Presenting the required nutrition (NARA). For information on the avail- information on any other label panel. ability of this material at NARA, call (h) Compliance with this section 202–741–6030, or go to: http:// shall be determined as follows: www.archives.gov/federallregister/ (1) A production lot is a set of food codeloflfederallregulations/ production consumer units that are ibrllocations.html. from one production shift. Alter- (3) Two classes of nutrients are de- natively, a collection of consumer fined for purposes of compliance: units of the same size, type, and style (i) Class I. Added nutrients in for- produced under conditions as nearly tified or fabricated foods; and uniform as possible, designated by a (ii) Class II. Naturally occurring (in- common container code or marking, digenous) nutrients. If any ingredient constitutes a production lot. which contains a naturally occurring (2) The sample for nutrient analysis (indigenous) nutrient is added to a shall consist of a composite of a min- food, the total amount of such nutrient imum of six consumer units, each from in the final food product is subject to a production lot. Alternatively, the Class II requirements unless the same sample for nutrient analysis shall con- nutrient is also added, which would sist of a composite of a minimum of six make the total amount of such nutri- consumer units, each randomly chosen ent subject to Class I requirements. to be representative of a production (4) A product with a label declaration lot. In each case, the units may be indi- of a vitamin, mineral, protein, total vidually analyzed and the results of the carbohydrate, dietary fiber, other car- analyses averaged, or the units would bohydrate, polyunsaturated or be composited and the composite ana- monounsaturated fat, or potassium lyzed. In both cases, the results, wheth- shall be deemed to be misbranded er an average or a single result from a under section 1(n) of the Federal Meat composite, will be considered by the Inspection Act (21 U.S.C. 601(n)(1)) un- Agency to be the nutrient content of a less it meets the following require- composite. All analyses shall be per- ments: formed by appropriate methods and (i) Class I vitamin, mineral, protein, procedures used by the Department for dietary fiber, or potassium. The nutri- each nutrient in accordance with the ent content of the composite is at least ‘‘Chemistry Laboratory Guidebook,’’ equal to the value for that nutrient de- or, if no USDA method is available and clared on the label. appropriate for the nutrient, by appro- (ii) Class II vitamin, mineral, propriate methods for the nutrient in ac- tein, total carbohydrate, dietary fiber, cordance with the 1990 edition of the other carbohydrate, polyunsaturated ‘‘Official Methods of Analysis’’ of the or monounsaturated fat, or potassium. AOAC International, formerly Associa- The nutrient content of the composite tion of Official Analytical Chemists, is at least equal to 80 percent of the 15th ed., which is incorporated by ref- value for that nutrient declared on the erence, unless a particular method of label; Provided, That no regulatory ac- analysis is specified in § 317.309(c), or, if tion will be based on a determination no USDA, AOAC, or specified method is of a nutrient value which falls below available and appropriate, by other re- this level by an amount less than the liable and appropriate analytical pro- variability generally recognized for the cedures as so determined by the Agen- analytical method used in that product cy. The ‘‘Official Methods of Analysis’’ at the level involved, and inherent nu- is incorporated as it exists on the date trient variation in a product. of approval. This incorporation by ref- (5) A product with a label declaration erence was approved by the Director of of calories, sugars, total fat, saturated the Federal Register in accordance fat, cholesterol, or sodium shall be with 5 U.S.C. 552(a) and 1 CFR part 51. deemed to be misbranded under section

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1(n) of the Federal Meat Inspection Act 2011, the effectiveness was delayed until Mar. (21 U.S.C. 601(n)(1)) if the nutrient con- 1, 2012. tent of the composite is greater than 20 a. In paragraph (b)(3), the first sentence is amended by adding ‘‘that are not ground or percent in excess of the value for that chopped meat products described in § 317.301’’ nutrient declared on the label; Pro- after the phrase ‘‘single-ingredient, raw vided, That no regulatory action will be products’’, and by removing ‘‘as set forth in based on a determination of a nutrient § 317.345(a)(1)’’; the second sentence is amend- value which falls above this level by an ed by adding, ‘‘that are not ground or amount less than the variability gen- chopped meat products described in § 317.301’’ erally recognized for the analytical after the phrase ‘‘single-ingredient, raw products’’, and the following new sentence is method used in that product at the added after the first sentence: ‘‘For single- level involved, and inherent nutrient ingredient, raw products that are not ground variation in a product. or chopped meat products described in (6) The amount of a vitamin, mineral, § 317.301, if data are based on the product ’as protein, total carbohydrate, dietary consumed,’ the data must be presented in ac- fiber, other carbohydrate, polyunsat- cordance with § 317.345(d)’’; urated or monounsaturated fat, or po- b. Amend paragraph (b)(10) by adding the following new sentence at the end of the tassium may vary over labeled paragraph: ‘‘The declaration of the number amounts within good manufacturing of servings per container need not be in- practice. The amount of calories, sug- cluded in nutrition labeling of single-ingre- ars, total fat, saturated fat, choles- dient, raw meat products that are not ground terol, or sodium may vary under la- or chopped meat products described in beled amounts within good manufac- § 317.301, including those that have been pre- turing practice. viously frozen.’’; c. Amend paragraph (b)(11) by adding the (7) Compliance will be based on the phrase ‘‘single-ingredient, raw products that metric measure specified in the label are not ground or chopped meat products de- statement of serving size. scribed in § 317.301 and’’ after ‘‘exception of’’; (8) The management of the establish- d. Amend paragraph (d)(3)(ii) by removing ment must maintain records to support the period and adding ‘‘or on single-ingredient, raw meat products that are not ground the validity of nutrient declarations or chopped meat products described in contained on product labels. Such § 317.301.’’ at the end of the paragraph; records shall be made available to the e. Amend paragraph (e)(3) by adding ‘‘, but inspector or any duly authorized rep- may be on the basis of ’as consumed’ for sin- resentative of the Agency upon re- gle-ingredient, raw meat products that are quest. not ground or chopped meat products de- (9) The compliance provisions set scribed in § 317.301,’’ after ‘‘as packaged’’; and f. Amend paragraph (h)(9) by removing the forth in paragraph (h) (1) through (8) of phrase ‘‘(including ground beef)’’, by adding, this section shall not apply to single- ‘‘that are not ground or chopped meat prod- ingredient, raw meat (including ground ucts described in § 317.301’’ after ‘‘products’’, beef) products, including those that by removing the phrase, ‘‘its published form, have been previously frozen, when nu- the Agriculture Handbook No. 8 series avail- trition labeling is based on the most able from the Government Printing Office’’, current representative data base values and by adding, in its place, ‘‘its released form, the USDA National Nutrient Database contained in USDA’s National Nutrient for Standard Reference’’, and by removing Data Bank or its published form, the the period and adding the following at the Agriculture Handbook No. 8 series end of the paragraph: ’’ as provided in available from the Government Print- § 317.345(e) and (f).’’ ing Office. §§ 317.310–317.311 [Reserved] (Paperwork requirements were approved by the Office of Management and Budget under § 317.312 Reference amounts custom- control number 0583–0088) arily consumed per eating occasion. [58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, (a) The general principles followed in 1993; 58 FR 47627, Sept. 10, 1993; 59 FR 45194, arriving at the reference amounts cus- Sept. 1, 1994; 60 FR 176, Jan. 3, 1995; 69 FR tomarily consumed per eating occasion 58801, Oct. 1, 2004] (Reference Amount(s)), as set forth in EFFECTIVE DATE NOTE: At 75 FR 82165, Dec. paragraph (b) of this section, are: 29, 2010, § 317.309 was amended as follows, ef- (1) The Reference Amounts are cal- fective Jan. 1, 2012. At 76 FR 76890, Dec. 9, culated for persons 4 years of age or

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older to reflect the amount of food cus- Amount and, in turn, the serving size tomarily consumed per eating occasion declared on the product label are based by persons in this population group. on only the edible portion of food, and These Reference Amounts are based on not bone, seed, shell, or other inedible data set forth in appropriate national components. food consumption surveys. (7) The Reference Amount is based on (2) The Reference Amounts are cal- the major intended use of the product culated for an infant or child under 4 (e.g., a mixed dish measurable with a years of age to reflect the amount of cup as a main dish and not as a side food customarily consumed per eating dish). occasion by infants up to 12 months of (8) The Reference Amounts for prod- age or by children 1 through 3 years of ucts that are consumed as an ingre- age, respectively. These Reference dient of other products, but that may Amounts are based on data set forth in also be consumed in the form in which appropriate national food consumption they are purchased (e.g., ground beef), surveys. Such Reference Amounts are are based on use in the form purchased. to be used only when the product is specially formulated or processed for (9) FSIS sought to ensure that foods use by an infant or by a child under 4 that have similar dietary usage, prod- years of age. uct characteristics, and customarily (3) An appropriate national food con- consumed amounts have a uniform Ref- sumption survey includes a large sam- erence Amount. ple size representative of the demo- (b) The following Product Categories graphic and socioeconomic characteris- and Reference Amounts shall be used tics of the relevant population group as the basis for determining serving and must be based on consumption sizes for specific products: data under actual conditions of use. (4) To determine the amount of food TABLE 1—REFERENCE AMOUNTS CUSTOMARILY customarily consumed per eating occa- CONSUMED PER EATING OCCASION—INFANT sion, the mean, median, and mode of AND TODDLER FOODS 1,2,3 the consumed amount per eating occa- Reference sion were considered. Product category amount (5) When survey data were insufficient, FSIS took various other sources Infant & Toddler Foods: of information on serving sizes of food Dinner Dry Mix ...... 15 g Dinner, ready-to-serve, strained type ...... 60 g into consideration. These other sources Dinner, soups, ready-to-serve junior type ...... 110 g of information included: Dinner, stew or soup ready-to-serve toddlers 170 g (i) Serving sizes used in dietary guid- Plain meats and meat sticks, ready-to-serve .. 55 g ance recommendations or rec- 1 These values represent the amount of food customarily ommended by other authoritative sys- consumed per eating occasion and were primarily derived tems or organizations; from the 1977–1978 and the 1987–1988 Nationwide Food Consumption Surveys conducted by the U.S. Department of (ii) Serving sizes recommended in Agriculture. comments; 2 Unless otherwise noted in the Reference Amount column, the Reference Amounts are for the ready-to-serve or almost (iii) Serving sizes used by manufac- ready-to-serve form of the product (i.e., heat and serve). If not turers and grocers; and listed separately, the Reference Amount for the unprepared form (e.g., dehydrated cereal) is the amount required to make (iv) Serving sizes used by other coun- one Reference Amount of the prepared form. tries. 3 Manufacturers are required to convert the Reference Amount to the label serving size in a household measure (6) Because they reflect the amount most appropriate to their specific product using the proce- customarily consumed, the Reference dures established by regulation.

TABLE 2—REFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASION—GENERAL FOOD SUPPLY 1,2,3,4,5

Reference Reference Product category amount amount Ready-to-serve Ready-to-cook

Egg mixtures, (western style omelet, souffle, egg foo young ...... 110 g n/a. Lard, margarine, shortening ...... 1 tbsp n/a. Salad and potato toppers; e.g., bacon bits ...... 7 g n/a.

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TABLE 2—REFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASION—GENERAL FOOD SUPPLY 1,2,3,4,5—Continued

Reference Reference Product category amount amount Ready-to-serve Ready-to-cook

Bacon (bacon, beef breakfast strips, pork breakfast strips, pork rinds) ...... 15 g 54 g=bacon. 30 g = breakfast strips. Dried; e.g., jerky, dried beef, Parma ham sausage products with a moisture/protein ratio 30 g n/a. of less than 2:1; e.g., pepperoni. Snacks; e.g., meat snack food sticks ...... 30 g n/a. Luncheon meat, bologna, Canadian style bacon, pork pattie crumbles, beef pattie crum- 55 g n/a. bles, blood pudding, luncheon loaf, old fashioned loaf, berlinger, bangers, minced luncheon roll, thuringer, liver sausage, mortadella, uncured sausage (franks), ham and cheese loaf, P&P loaf, scrapple souse, head cheese, pizza loaf, olive loaf, pate, deviled ham, sandwich spread, teawurst, cervelet, Lebanon bologna, potted meat food product, taco fillings, meat pie fillings. Linked meat sausage products, Vienna sausage, frankfurters, pork sausage, imitation 55 g n/a. 75 frankfurters, bratwurst, kielbasa, Polish sausage, summer sausage, mettwurst, g=uncooked smoked country sausage, smoked sausage, smoked or pickled meat, pickled pigs feet. sausage. Entrees without sauce, cuts of meat including marinated, tenderized, injected cuts of 85 g 114 g. meat, beef patty, corn dog, croquettes, fritters, cured ham, dry cured ham, dry cured cappicola, corned beef, pastrami, country ham, pork shoulder picnic, meatballs, pureed adult foods. Canned meats, canned beef, canned pork. 4 ...... 55 g n/a. Entrees with sauce, barbecued meats in sauce ...... 140 g n/a. Mixed dishes NOT measurable with a cup; 5 e.g., burrito, egg roll, enchilada, pizza, 140 g (plus 55 g n/a. pizza roll, quiche, all types of sandwiches, cracker and meat lunch type packages, for products gyro, stromboli, burger on a bun, frank on a bun, calzone, taco, pockets stuffed with with sauce top- meat, foldovers, stuffed vegetables with meat, shish kabobs, empanada. pings) Mixed dishes measurable with a cup; e.g., meat casserole, macaroni and cheese with 1 cup n/a. meat, pot pie, spaghetti with sauce, meat chili, chili with beans, meat hash, creamed chipped beef, beef ravioli in sauce, beef stroganoff, Brunswick stew, goulash, meat stew, ragout, meat lasagna, meat filled pasta. Salads—pasta or potato, potato salad with bacon, macaroni and meat salad ...... 140 g n/a. Salads—all other meat, salads, ham salad ...... 100 g n/a. Soups—all varieties ...... 245 g n/a. Major main entree type sauce; e.g., spaghetti sauce with meat, spaghetti sauce with 125 g n/a. meatballs. Minor main entree sauce; e.g., pizza sauce with meat, gravy ...... 1⁄4 cup n/a. Seasoning mixes dry, bases, extracts, dried broths and stock/juice, freeze dry trail mix products with meat.. As reconstituted: Amount to make one Reference Amount of the final dish; e.g., Gravy ...... 1⁄4 cup n/a. Major main entree type sauce ...... 125 g n/a. Soup ...... 245 g n/a. Entree measurable with a cup ...... 1 cup n/a. 1 These values represent the amount of food customarily consumed per eating occasion and were primarily derived from the 1977–78 and the 1987–88 Nationwide Food Consumption Surveys conducted by the U.S. Department of Agriculture. 2 Manufacturers are required to convert the Reference Amounts to the label serving size in a household measure most appropriate to their specific product using the procedures established by regulation. 3 Examples listed under Product Category are not all inclusive or exclusive. Examples are provided to assist manufacturers in identifying appropriate product Reference Amount. 4 If packed or canned in liquid, the Reference Amount is for the drained solids, except for products in which both the solids and liquids are customarily consumed. 5 Pizza sauce is part of the pizza and is not considered to be sauce topping.

(c) For products that have no Ref- (1) For bulk products, the Reference erence Amount listed in paragraph (b) Amount for the combined product shall of this section for the unprepared or be the Reference Amount, as estab- the prepared form of the product and lished in paragraph (b) of this section, that consist of two or more foods pack- for the ingredient that is represented aged and presented to be consumed to- as the main ingredient plus propor- gether (e.g., lunch meat with cheese tioned amounts of all minor ingredi- and crackers), the Reference Amount ents. for the combined product shall be de- (2) For products where the ingredient termined using the following rules: represented as the main ingredient is

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one or more discrete units, the Ref- fers from the Reference Amount, and erence Amount for the combined prod- the product meets the criteria for the uct shall be either the number of small claim only on the basis of the Ref- discrete units or the fraction of the erence Amount, the claim shall be fol- large discrete unit that is represented lowed by a statement that sets forth as the main ingredient that is closest the basis on which the claim is made. to the Reference Amount for that in- That statement shall include the Ref- gredient as established in paragraph (b) erence Amount as it appears in para- of this section plus proportioned graph (b) of this section followed, in amounts of all minor ingredients. parentheses, by the amount in common (3) If the Reference Amounts are in household measure if the Reference compatible units, they shall be Amount is expressed in measures other summed (e.g., ingredients in equal vol- than common household measures. umes such as tablespoons). If the Ref- (g) The Administrator, on his or her erence Amounts are in incompatible own initiative or on behalf of any in- units, the weights of the appropriate terested person who has submitted a volumes should be used (e.g., grams of labeling application, may issue a pro- one ingredient plus gram weight of ta- posal to establish or amend a Product blespoons of a second ingredient). Category or Reference Amount identi- (d) If a product requires further prep- fied in paragraph (b) of this section. aration, e.g., cooking or the addition of (1) Labeling applications and sup- water or other ingredients, and if para- porting documentation to be filed graph (b) of this section provides a Ref- under this section shall be submitted erence Amount for the product in the in quadruplicate, except that the sup- prepared form, then the Reference porting documentation may be sub- Amount for the unprepared product mitted on a computer disc copy. If any shall be determined using the following part of the material submitted is in a rules: foreign language, it shall be accom- (1) Except as provided for in para- panied by an accurate and complete graph (d)(2) of this section, the Ref- English translation. The labeling appli- erence Amount for the unprepared cation shall state the applicant’s post product shall be the amount of the un- office address. prepared product required to make the (2) Pertinent information will be con- Reference Amount for the prepared sidered as part of an application on the product as established in paragraph (b) basis of specific reference to such infor- of this section. mation submitted to and retained in (2) For products where the entire the files of the Food Safety and Inspec- contents of the package is used to pre- tion Service. However, any reference to pare one large discrete unit usually di- unpublished information furnished by a vided for consumption, the Reference person other than the applicant will Amount for the unprepared product not be considered unless use of such in- shall be the amount of the unprepared formation is authorized (with the un- product required to make the fraction derstanding that such information may of the large discrete unit closest to the in whole or part be subject to release Reference Amount for the prepared to the public) in a written statement product as established in paragraph (b) signed by the person who submitted it. of this section. Any reference to published information (e) The Reference Amount for an imi- should be accompanied by reprints or tation or substitute product or altered photostatic copies of such references. product as defined in § 317.313(d), such (3) The availability for public disclo- as a ‘‘low calorie’’ version, shall be the sure of labeling applications, along same as for the product for which it is with supporting documentation, sub- offered as a substitute. mitted to the Agency under this sec- (f) The Reference Amounts set forth tion will be governed by the rules spec- in paragraphs (b) through (e) of this ified in subchapter D, title 9. section shall be used in determining (4) Data accompanying the labeling whether a product meets the criteria application, such as food consumption for nutritional claims. If the serving data, shall be submitted on separate size declared on the product label dif- sheets, suitably identified. If such data

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has already been submitted with an components) for the population group for earlier labeling application from the which the product is intended with full de- applicant, the present labeling applica- scription of the methodology and procedures tion must provide the data. that were used to determine the suggested Reference Amount. In determining the Ref- (5) The labeling application must be erence Amount, general principles and fac- signed by the applicant or by his or her tors in paragraph (a) of this section should attorney or agent, or (if a corporation) be followed. by an authorized official. (x) The suggested Reference Amount shall (6) The labeling application shall in- be expressed in metric units. Reference clude a statement signed by the person Amounts for foods shall be expressed in responsible for the labeling applica- grams except when common household units tion, that to the best of his or her such as cups, tablespoons, and teaspoons are more appropriate or are more likely to pro- knowledge, it is a representative and mote uniformity in serving sizes declared on balanced submission that includes un- product labels. For example, common house- favorable information, as well as favor- hold measures would be more appropriate if able information, known to him or her products within the same category differ pertinent to the evaluation of the la- substantially in density such as mixed dishes beling application. measurable with a cup. (7) Labeling applications for a new (A) In expressing the Reference Amount in Reference Amount and/or Product Cat- grams, the following general rules shall be followed: egory shall be accompanied by the fol- (1) For quantities greater than 10 grams, lowing data which shall be submitted the quantity shall be expressed in nearest 5 in the following form to the Director, grams increment. Food Labeling Division, Regulatory (2) For quantities less than 10 grams, exact Programs, Food Safety and Inspection gram weights shall be used. Service, Washington, DC 20250: (B) [Reserved] (xi) A labeling application for a new sub- llllllllllllllllllllllll category of food with its own Reference (Date) Amount shall include the following addi- The undersigned, llllll submits this tional information: labeling application pursuant to 9 CFR (A) Data that demonstrate that the new 317.312 with respect to Reference Amount subcategory of food will be consumed in and/or Product Category. amounts that differ enough from the Ref- Attached hereto, in quadruplicate, or on a erence Amount for the parent category to computer disc copy, and constituting a part warrant a separate Reference Amount. Data of this labeling application, are the fol- must include sample size, and the mean, lowing: standard deviation, median, and modal con- (i) A statement of the objective of the la- sumed amount per eating occasion for the beling application; product identified in the labeling application (ii) A description of the product; and for other products in the category. All (iii) A complete sample product label in- data must be derived from the same survey cluding nutrition label, using the format es- data. tablished by regulation; (B) Documentation supporting the dif- (iv) A description of the form in which the ference in dietary usage and product charac- product will be marketed; teristics that affect the consumption size (v) The intended dietary uses of the prod- that distinguishes the product identified in uct with the major use identified (e.g., ham the labeling application from the rest of the as a luncheon meat); products in the category. (vi) If the intended use is primarily as an (xii) In conducting research to collect or ingredient in other foods, list of foods or food process food consumption data in support of categories in which the product will be used the labeling application, the following gen- as an ingredient with information on the eral guidelines should be followed. prioritization of the use; (A) Sampled population selected should be (vii) The population group for which the representative of the demographic and socio- product will be offered for use (e.g., infants, economic characteristics of the target popu- children under 4 years of age); lation group for which the food is intended. (viii) The names of the most closely-re- (B) Sample size (i.e., number of eaters) lated products (or in the case of foods for should be large enough to give reliable esti- special dietary use and imitation or sub- mates for customarily consumed amounts. stitute foods, the names of the products for (C) The study protocol should identify po- which they are offered as substitutes); tential biases and describe how potential bi- (ix) The suggested Reference Amount (the ases are controlled for or, if not possible to amount of edible portion of food as con- control, how they affect interpretation of resumed, excluding bone, skin or other inedible sults.

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(D) The methodology used to collect or cation, answer, and the request for a process data including study design, sam- hearing, which shall constitute the pling procedures, materials used (e.g., ques- complaint and answer in the pro- tionnaire, interviewer’s manual), procedures used to collect or process data, methods or ceeding, which shall thereafter be con- procedures used to control for unbiased esti- ducted in accordance with the Depart- mates, and procedures used to correct for ment’s Uniform Rules of Practice. nonresponse, should be fully documented. (ii) The hearing shall be conducted (xiii) A statement concerning the feasi- before an administrative law judge bility of convening associations, corpora- with the opportunity for appeal to the tions, consumers, and other interested par- ties to engage in negotiated rulemaking to Department’s Judicial Officer, who develop a proposed rule. shall make the final determination for Yours very truly, the Secretary. Any such determination Applicant lllllllllllllll by the Secretary shall be conclusive unless, within 30 days after receipt of By lllllllllllllllllll (Indicate authority) notice of such final determination, the applicant appeals to the United States (8) Upon receipt of the labeling appli- Court of Appeals for the circuit in cation and supporting documentation, which the applicant has its principal the applicant shall be notified, in writ- place of business or to the United ing, of the date on which the labeling States Court of Appeals for the District application was received. Such notice of Columbia Circuit. shall inform the applicant that the la- (11) If the labeling application is not beling application is undergoing Agen- summarily denied by the Adminis- cy review and that the applicant shall trator, the Administrator shall publish subsequently be notified of the Agen- in the FEDERAL REGISTER a proposed cy’s decision to consider for further re- rule to amend the regulations to au- view or deny the labeling application. thorize the use of the Reference (9) Upon review of the labeling appli- Amount and/or Product Category. The cation and supporting documentation, proposal shall also summarize the la- the Agency shall notify the applicant, in writing, that the labeling applica- beling application, including where the tion is either being considered for fur- supporting documentation can be re- ther review or that it has been sum- viewed. The Administrator’s proposed marily denied by the Administrator. rule shall seek comment from con- (10) If the labeling application is sumers, the industry, consumer and in- summarily denied by the Adminis- dustry groups, and other interested trator, the written notification shall persons on the labeling application and state the reasons therefor, including the use of the proposed Reference why the Agency has determined that Amount and/or Product Category. the proposed Reference Amount and/or After public comment has been re- Product Category is false or mis- ceived and reviewed by the Agency, the leading. The notification letter shall Administrator shall make a determina- inform the applicant that the applicant tion on whether the proposed Reference may submit a written statement by Amount and/or Product Category shall way of answer to the notification, and be approved for use on the labeling of that the applicant shall have the right meat food products. to request a hearing with respect to (i) If the Reference Amount and/or the merits or validity of the Adminis- Product Category is denied by the Ad- trator’s decision to deny the use of the ministrator, the Agency shall notify proposed Reference Amount and/or the applicant, in writing, of the basis Product Category. for the denial, including the reason (i) If the applicant fails to accept the why the Reference Amount and/or determination of the Administrator Product Category on the labeling was and files an answer and requests a determined by the Agency to be false hearing, and the Administrator, after or misleading. The notification letter review of the answer, determines the shall also inform the applicant that the initial determination to be correct, the applicant may submit a written state- Administrator shall file with the Hear- ment by way of answer to the notifica- ing Clerk of the Department the notifi- tion, and that the applicant shall have

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the right to request a hearing with re- the type required in nutrition labeling spect to the merits or validity of the pursuant to § 317.309, may not be made Administrator’s decision to deny the on a label or in labeling of that product use of the proposed Reference Amount unless the claim is made in accordance and/or Product Category. with the applicable provisions in this (A) If the applicant fails to accept subpart. the determination of the Adminis- (1) An expressed nutrient content trator and files an answer and requests claim is any direct statement about a hearing, and the Administrator, after the level (or range) of a nutrient in the review of an answer, determines the product, e.g., ‘‘low sodium’’ or ‘‘con- initial determination to be correct, the tains 100 calories.’’ Administrator shall file with the Hear- (2) An implied nutrient content claim ing Clerk of the Department the notifi- is any claim that: cation, answer, and the request for a (i) Describes the product or an ingre- hearing, which shall constitute the dient therein in a manner that sug- complaint and answer in the pro- gests that a nutrient is absent or ceeding, which shall thereafter be con- present in a certain amount (e.g., ducted in accordance with the Depart- ‘‘high in oat bran’’); or ment’s Uniform Rules of Practice. (B) The hearing shall be conducted (ii) Suggests that the product, be- before an administrative law judge cause of its nutrient content, may be with the opportunity for appeal to the useful in maintaining healthy dietary Department’s Judicial Officer, who practices and is made in association shall make the final determination for with an explicit claim or statement the Secretary. Any such determination about a nutrient (e.g., ‘‘healthy, con- by the Secretary shall be conclusive tains 3 grams (g) of fat’’). unless, within 30 days after receipt of (3) Except for claims regarding vita- the notice of such final determination, mins and minerals described in para- the applicant appeals to the United graph (q)(3) of this section, no nutrient States Court of Appeals for the circuit content claims may be made on prod- in which the applicant has its principal ucts intended specifically for use by inplace of business or to the United fants and children less than 2 years of States Court of Appeals for the District age unless the claim is specifically proof Columbia Circuit. vided for in subpart B of this part. (ii) If the Reference Amount and/or (4) Reasonable variations in the spell- Product Category is approved, the ing of the terms defined in applicable Agency shall notify the applicant, in provisions in this subpart and their writing, and shall also publish in the synonyms are permitted provided these FEDERAL REGISTER a final rule amend- variations are not misleading (e.g., ing the regulations to authorize the ‘‘hi’’ or ‘‘lo’’). use of the Reference Amount and/or (c) Information that is required or Product Category. permitted by § 317.309 to be declared in (Paperwork requirements were approved by nutrition labeling, and that appears as the Office of Management and Budget under part of the nutrition label, is not a nu- control number 0583–0088) trient content claim and is not subject to the requirements of this section. If [58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, 1993 as amended at 58 FR 47627, Sept. 10, 1993; such information is declared elsewhere 59 FR 45196, Sept. 1, 1994; 60 FR 186, Jan. 3, on the label or in labeling, it is a nutri- 1995] ent content claim and is subject to the requirements for nutrient content § 317.313 Nutrient content claims; gen- claims. eral principles. (d) A ‘‘substitute’’ product is one (a) This section applies to meat or that may be used interchangeably with meat food products that are intended another product that it resembles, i.e., for human consumption and that are that it is organoleptically, physically, offered for sale. and functionally (including shelf life) (b) A claim which, expressly or by similar to, and that it is not nutrition- implication, characterizes the level of ally inferior to unless it is labeled as a nutrient (nutrient content claim) of an ‘‘imitation.’’

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(1) If there is a difference in perform- than 1⁄16 inch in height, except as per- ance characteristics that materially mitted by § 317.400(d)(2). limits the use of the product, the prod- (h) [Reserved] uct may still be considered a substitute (i) Except as provided in § 317.309 or in if the label includes a disclaimer adja- paragraph (q)(3) of this section, the cent to the most prominent claim as label or labeling of a product may con- defined in paragraph (j)(2)(iii) of this tain a statement about the amount or section, informing the consumer of percentage of a nutrient if: such difference (e.g., ‘‘not rec- (1) The use of the statement on the ommended for frying’’). product implicitly characterizes the (2) This disclaimer shall be in easily level of the nutrient in the product and legible print or type and in a size no is consistent with a definition for a less than that required by § 317.2(h) for claim, as provided in subpart B of this the net quantity of contents state- part, for the nutrient that the label ad- ment, except where the size of the dresses. Such a claim might be, ‘‘less claim is less than two times the re- than 10 g of fat per serving;’’ quired size of the net quantity of con- (2) The use of the statement on the tents statement, in which case the dis- product implicitly characterizes the claimer statement shall be no less than level of the nutrient in the product and one-half the size of the claim but no is not consistent with such a defini- smaller than 1⁄16-inch minimum height, tion, but the label carries a disclaimer except as permitted by § 317.400(d)(2). adjacent to the statement that the (e)(1) Because the use of a ‘‘free’’ or ‘‘low’’ claim before the name of a prod- product is not ‘‘low’’ in or a ‘‘good uct implies that the product differs source’’ of the nutrient, such as ‘‘only from other products of the same type 200 milligrams (mg) sodium per serv- by virtue of its having a lower amount ing, not a low sodium product.’’ The of the nutrient, only products that disclaimer must be in easily legible have been specially processed, altered, print or type and in a size no less than formulated, or reformulated so as to required by § 317.2(h) for the net quan- lower the amount of the nutrient in tity of contents, except where the size the product, remove the nutrient from of the claim is less than two times the the product, or not include the nutri- required size of the net quantity of ent in the product, may bear such a contents statement, in which case the claim (e.g., ‘‘low sodium beef noodle disclaimer statement shall be no less soup’’). than one-half the size of the claim but 1 (2) Any claim for the absence of a nu- no smaller than ⁄16-inch minimum trient in a product, or that a product is height, except as permitted by low in a nutrient when the product has § 317.400(d)(2); not been specially processed, altered, (3) The statement does not in any formulated, or reformulated to qualify way implicitly characterize the level of for that claim shall indicate that the the nutrient in the product and it is product inherently meets the criteria not false or misleading in any respect and shall clearly refer to all products (e.g., ‘‘100 calories’’ or ‘‘5 grams of of that type and not merely to the par- fat’’), in which case no disclaimer is re- ticular brand to which the labeling at- quired. taches (e.g., ‘‘lard, a sodium free (4) ‘‘Percent fat free’’ claims are not food’’). authorized by this paragraph. Such (f) A nutrient content claim shall be claims shall comply with § 317.362(b)(6). in type size and style no larger than (j) A product may bear a statement two times that of the statement of that compares the level of a nutrient in identity and shall not be unduly promi- the product with the level of a nutrient nent in type style compared to the in a reference product. These state- statement of identity. ments shall be known as ‘‘relative (g) Labeling information required in claims’’ and include ‘‘light,’’ ‘‘re- §§ 317.313, 317.354, 317.356, 317.360, 317.361, duced,’’ ‘‘less’’ (or ‘‘fewer’’), and 317.362, and 317.380, whose type size is ‘‘more’’ claims. not otherwise specified, is required to (1) To bear a relative claim about the be in letters and/or numbers no less level of a nutrient, the amount of that

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nutrient in the product must be com- are consistent and will not cause con- pared to an amount of nutrient in an sumer confusion when compared), and appropriate reference product as speci- that the actual modification is at least fied in this paragraph (j). equal to the percentage specified in the (i)(A) For ‘‘less’’ (or ‘‘fewer’’) and definition of the claim. ‘‘more’’ claims, the reference product (2) For products bearing relative may be a dissimilar product within a claims: product category that can generally be (i) The label or labeling must state substituted for one another in the diet the identity of the reference product or a similar product. and the percent (or fraction) of the (B) For ‘‘light,’’ ‘‘reduced,’’ and amount of the nutrient in the reference ‘‘added’’ claims, the reference product product by which the nutrient has been shall be a similar product, and modified, (e.g., ‘‘50 percent less fat (ii)(A) For ‘‘light’’ claims, the ref- than ‘reference product’ ’’ or ‘‘1⁄3 fewer erence product shall be representative calories than ‘reference product’ ’’); and of the type of product that includes the (ii) This information shall be imme- product that bears the claim. The nu- diately adjacent to the most prominent trient value for the reference product claim in easily legible boldface print or shall be representative of a broad base type, in distinct contrast to other of products of that type; e.g., a value in printed or graphic matter, that is no a representative, valid data base; an less than that required by § 317.2(h) for average value determined from the top net quantity of contents, except where three national (or regional) brands, a the size of the claim is less than two market basket norm; or, where its nu- times the required size of the net quan- trient value is representative of the tity of contents statement, in which product type, a market leader. Firms case the referral statement shall be no using such a reference nutrient value less than one-half the size of the claim, as a basis for a claim, are required to but no smaller than 1⁄16-inch minimum provide specific information upon height, except as permitted by which the nutrient value was derived, § 317.400(d)(2). on request, to consumers and appro- (iii) The determination of which use priate regulatory officials. of the claim is in the most prominent (B) For relative claims other than location on the label or labeling will be ‘‘light,’’ including ‘‘less’’ and ‘‘more’’ made based on the following factors, claims, the reference product may be considered in order: the same as that provided for ‘‘light’’ (A) A claim on the principal display in paragraph (j)(1)(ii)(A) of this section panel adjacent to the statement of or it may be the manufacturer’s reg- identity; ular product, or that of another manu- (B) A claim elsewhere on the prin- facturer, that has been offered for sale cipal display panel; to the public on a regular basis for a substantial period of time in the same (C) A claim on the information panel; geographic area by the same business or entity or by one entitled to use its (D) A claim elsewhere on the label or trade name, provided the name of the labeling. competitor is not used on the labeling (iv) The label or labeling must also of the product. The nutrient values bear: used to determine the claim when com- (A) Clear and concise quantitative in- paring a single manufacturer’s product formation comparing the amount of to the labeled product shall be either the subject nutrient in the product per the values declared in nutrition label- labeled serving size with that in the ing or the actual nutrient values, pro- reference product; and vided that the resulting labeling is in- (B) This statement shall appear adja- ternally consistent (i.e., that the val- cent to the most prominent claim or to ues stated in the nutrition informa- the nutrition information. tion, the nutrient values in the accom- (3) A relative claim for decreased lev- panying information, and the declara- els of a nutrient may not be made on tion of the percentage of nutrient by the label or in labeling of a product if which the product has been modified the nutrient content of the reference

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product meets the requirement for a (A) Bread, cereal, rice, and pasta; ‘‘low’’ claim for that nutrient. (B) Fruits and vegetables; (k) The term ‘‘modified’’ may be used (C) Milk, yogurt, and cheese; in the statement of identity of a prod- (D) Meat, poultry, fish, dry beans, uct that bears a relative claim that eggs, and nuts; except that: complies with the requirements of this (E) These foods will not be sauces part, followed immediately by the (except for foods in the four food name of the nutrient whose content groups in paragraph (m)(l)(ii)(A) has been altered (e.g., ‘‘modified fat through (D) of this section, that are in ‘product’ ’’). This statement of identity the sauces), gravies, condiments, rel- must be immediately followed by the ishes, pickles, olives, jams, jellies, syr- comparative statement such as ‘‘con- ups, breadings, or garnishes; and tains 35 percent less fat than ‘reference (3) Is represented as, or is in a form product’ ’’ The label or labeling must commonly understood to be, a main also bear the information required by dish (e.g., not a beverage or dessert). paragraph (j)(2) of this section in the Such representations may be made by manner prescribed. statements, photographs, or vignettes. (l) For purposes of making a claim, a (n) Nutrition labeling in accordance ‘‘meal-type’’ product will be defined as with § 317.309, shall be provided for any a product that: food for which a nutrient content claim (1) Makes a major contribution to the is made. diet by: (o) Compliance with requirements for (i) Weighing at least 10 ounces per la- nutrient content claims shall be in ac- beled serving; and cordance with § 317.309(h). (ii) Containing not less than three 40 (p)(1) Unless otherwise specified, the gram portions of food, or combinations reference amount customarily con- of foods, from two or more of the fol- sumed set forth in § 317.312(b) through lowing four food groups, except as (e) shall be used in determining wheth- noted in paragraph (l)(1)(ii)(E) of this er a product meets the criteria for a section: nutrient content claim. If the serving (A) Bread, cereal, rice, and pasta; size declared on the product label dif- (B) Fruits and vegetables; fers from the reference amount cus- (C) Milk, yogurt, and cheese; tomarily consumed, and the amount of (D) Meat, poultry, fish, dry beans, the nutrient contained in the labeled eggs, and nuts; except that: serving does not meet the maximum or (E) These foods will not be sauces minimum amount criterion in the defi- (except for foods in the four food nition for the descriptor for that nutri- groups in paragraph (l)(1)(ii)(A) ent, the claim shall be followed by the through (D) of this section, that are in criteria for the claim as required by the sauces), gravies, condiments, rel- § 317.312(f) (e.g., ‘‘very low sodium, 35 ishes, pickles, olives, jams, jellies, syr- mg or less per 55 grams’’). ups, breadings, or garnishes; and (2) The criteria for the claim shall be (2) Is represented as, or is in the form immediately adjacent to the most commonly understood to be, a break- prominent claim in easily legible print fast, lunch, dinner, meal, or entre. or type and in a size that is no less Such representations may be made by than that required by § 317.2(h) for net statements, photographs, or vignettes. quantity of contents, except where the (m) For purposes of making a claim, size of the claim is less than two times a main-dish product will be defined as the required size of the net quantity of a food that: contents statement, in which case the (1) Makes a major contribution to the criteria statement shall be no less than meal by: one-half the size of the claim but no (i) Weighing at least 6 ounces per la- smaller than 1⁄16-inch minimum height, beled serving; and except as permitted by § 317.400(d)(2). (ii) Containing not less than 40 grams (q) The following exemptions apply: of food, or combinations of foods, from (1) Nutrient content claims that have two or more of the following four food not been defined by regulation and that groups, except as noted in paragraph appear as part of a brand name that (m)(1)(ii)(E) of this section. was in use prior to November 27, 1991,

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may continue to be used as part of that tion information is displayed at point- brand name, provided they are not of-purchase in an approriate manner. false or misleading under section 1(n) (c) To determine whether there is sig- of the Act (21 U.S.C. 601(n)(1)). nificant participation by retailers (2) [Reserved] under the voluntary nutrition labeling (3) A statement that describes the guidelines, FSIS will select a rep- percentage of a vitamin or mineral in resentative sample of companies allo- the food, including foods intended spe- cated by type and size. cifically for use by infants and children (d) FSIS will find that significant less than 2 years of age, in relation to participation by food retailers exists if a Reference Daily Intake (RDI) as de- at least 60 percent of all companies fined in § 317.309 may be made on the that are evaluated are participating in label or in the labeling of a food with- accordance with the guidelines. out a regulation authorizing such a (e) FSIS will evaluate significant claim for a specific vitamin or mineral. participation of the voluntary program (4) The requirements of this section every 2 years beginning in May 1995. do not apply to infant formulas and (1) If significant participation is medical foods, as described in 21 CFR found, the voluntary nutrition labeling 101.13(q)(4). guidelines shall remain in effect. (5) [Reserved] (2) If significant participation is not (6) Nutrient content claims that were found, FSIS shall initiate rulemaking part of the name of a product that was to require nutrition labeling on those subject to a standard of identity as of products under the voluntary program. November 27, 1991, are not subject to EFFECTIVE DATE NOTE: At 75 FR 82165, Dec. the requirements of paragraph (b) of 29, 2010, § 317.343 was removed, effective Jan. this section whether or not they meet 1, 2012. At 76 FR 76890, Dec. 9, 2011, the effec- the definition of the descriptive term. tiveness was delayed until Mar. 1, 2012. (7) Implied nutrient content claims § 317.344 Identification of major cuts may be used as part of a brand name, of meat products. provided that the use of the claim has been authorized by FSIS. Labeling ap- The major cuts of single-ingredient, raw meat products are: Beef chuck plications requesting approval of such blade roast, beef loin top loin steak, a claim may be submitted pursuant to beef rib roast large end, beef round eye § 317.369. round steak, beef round top round [58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, steak, beef round tip roast, beef chuck 1993, as amended at 58 FR 47627, Sept. 10, arm pot roast, beef loin sirloin steak, 1993; 59 FR 40213, Aug. 8, 1994; 59 FR 45196, beef round bottom round steak, beef Sept. 1, 1994; 60 FR 187, Jan. 3, 1995; 69 FR brisket (whole, flat half, or point half), 58801, Oct. 1, 2004] beef rib steak small end, beef loin ten- §§ 317.314–317.342 [Reserved] derloin steak, ground beef regular without added seasonings, ground beef § 317.343 Significant participation for about 17% fat, pork loin chop, pork voluntary nutrition labeling. loin country style ribs, pork loin top loin chop boneless, pork loin rib chop, (a) In evaluating significant partici- pork spareribs, pork loin tenderloin, pation for voluntary nutrition labeling, pork loin sirloin roast, pork shoulder FSIS will consider only the major cuts blade steak, pork loin top roast of single-ingredient, raw meat prod- boneless, ground pork, lamb shank, ucts, as identified in § 317.344, including lamb shoulder arm chop, lamb shoulder those that have been previously frozen. blade chop, lamb rib roast, lamb loin (b) FSIS will judge a food retailer to chop, lamb leg (whole, sirloin half, or be participating at a significant level if shank half), veal shoulder arm steak, the retailer provides nutrition labeling veal shoulder blade steak, veal rib information for at least 90 percent of roast, veal loin chop, and veal cutlets. the major cuts of single-ingredient, raw meat products, listed in § 317.344, [58 FR 664, Jan. 6, 1993, as amended at 59 FR that it sells, and if the nutrition label 45196, Sept. 1, 1994] is consistent in content and format EFFECTIVE DATE NOTE: At 75 FR 82165, Dec. with the mandatory program, or nutri- 29, 2010, § 317.344 was amended by removing

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the phrases ‘‘ground beef regular without (c) The declaration of nutrition infor- added seasonings, ground beef about 17% mation may be presented in a sim- fat,’’ and ‘‘ground pork’’, effective Jan. 1, plified format as specified in § 317.309(f) 2012. At 76 FR 76890, Dec. 9, 2011, the effec- for the mandatory nutrition labeling tiveness was delayed until Mar. 1, 2012. program. § 317.345 Guidelines for voluntary nu- (d) The nutrition label data should be trition labeling of single-ingredient, based on either the raw or cooked edi- raw products. ble portions of meat cuts with external cover fat at trim levels reflecting cur- (a) Nutrition information on the cuts rent marketing practices. If data are of single-ingredient, raw meat prod- based on cooked portions, the methods ucts, including those that have been used to cook the products must be previously frozen, shall be provided in specified and should be those which do the following manner: not add nutrients from other ingredi- (1) If a retailer or manufacturer ents such as flour, breading, and salt. chooses to provide nutrition informa- Additional nutritional data may be tion on the label of these products, presented on an optional basis for the these products shall be subject to all raw or cooked edible portions of the requirements of the mandatory nutri- separable lean of meat cuts. tion labeling program, except that nu- (e) Nutrient data that are the most trition labeling may be declared on the current representative data base values basis of either ‘‘as consumed’’ or ‘‘as contained in USDA’s National Nutrient packaged.’’ In addition, the declaration Data Bank or its published form, the of the number of servings per container Agriculture Handbook No. 8 series, need not be included in nutrition label- may be used for nutrition labeling of ing of single-ingredient, raw meat single-ingredient, raw meat products products (including ground beef), in- (including ground beef), including cluding those that have been pre- those that have been previously frozen. viously frozen. These data may be composite data that (2) A retailer may choose to provide reflect different quality grades of beef nutrition information at the point-of- or other variables affecting nutrient purchase, such as by posting a sign, or content. Alternatively, data that re- by making the information readily flect specific grades or other variables available in brochures, notebooks, or may be used, except that if data are leaflet form in close proximity to the used on labels attached to a product food. The nutrition labeling informa- which is labeled as to grade of meat or tion may also be supplemented by a other variables, the data must rep- video, live demonstration, or other resent the product in the package when media. If a nutrition claim is made on such data are contained in the rep- point-of-purchase materials all of the resentative data base. When data are requirements of the mandatory nutri- used on labels attached to a product, tion labeling program apply. However, the data must represent the edible if only nutrition information—and not meat tissues present in the package. a nutrition claim—is supplied on point- (f) If the nutrition information is in of-purchase materials: accordance with paragraph (e) of this (i) The requirements of the manda- section, a nutrition label or labeling tory nutrition labeling program apply, will not be subject to the Agency com- but the nutrition information may be pliance review under § 317.309(h), unless supplied on an ‘‘as packaged’’ or ‘‘as a nutrition claim is made on the basis consumed,’’ basis; of the representative data base values. (ii) The listing of percent of Daily (g) Retailers may use data bases that Value for the nutrients (except vita- they believe reflect the nutrient con- mins and minerals specified in tent of single-ingredient, raw meat § 317.309(c)(8)) and footnote required by products (including ground beef), in- § 317.309(d)(9) may be omitted; and cluding those that have been pre- (iii) The point-of-purchase materials viously frozen; however, such labeling are not subject to any of the format re- shall be subject to the compliance pro- quirements. cedures of paragraph (e) of this section (b) [Reserved] and the requirements specified in this

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subpart for the mandatory nutrition tion—and not a nutrition claim—is supplied labeling program. on point-of-purchase materials, the requirements of § 317.309 apply, provided, however: [58 FR 664, Jan. 6, 1993, as amended at 58 FR (i) The listing of percent of Daily Value for 47627, Sept. 10, 1993; 60 FR 189, Jan. 3, 1995] the nutrients (except vitamins and minerals EFFECTIVE DATE NOTE: At 75 FR 82165, Dec. specified in § 317.309(c)(8)) and footnote re- 29, 2010, § 317.345 was amended as follows, ef- quired by § 317.309(d)(9) may be omitted; and fective Jan. 1, 2012. At 76 FR 76890, Dec. 9, (ii) The point-of-purchase materials are 2011, the effectiveness was delayed until Mar. not subject to any of the format require- 1, 2012. ments. a. Revise the section heading and paragraphs (a) and (c); b. Amend paragraph (d) by removing * * * * * ‘‘should’’ and adding, in its place, ‘‘for prod- (c) For the point-of-purchase materials, ucts covered in paragraphs (a)(1) and (a)(2) the declaration of nutrition information may must’’; be presented in a simplified format as speci- c. Amend paragraph (e) by removing ‘‘its fied in § 317.309(f). published form, the Agriculture Handbook No. 8 series’’ and by adding, in its place, ‘‘its released form, the USDA National Nutrient * * * * * Database for Standard Reference’’, and by removing ‘‘(including ground beef)’’; §§ 317.346–317.353 [Reserved] d. Amend paragraph (f) by adding ‘‘provided’’ after ‘‘nutrition information is’’; and § 317.354 Nutrient content claims for e. Amend paragraph (g) by removing the ‘‘good source,’’ ‘‘high,’’ and ‘‘more.’’ phrase ‘‘(including ground beef)’’. For the convenience of the user, the re- (a) General requirements. Except as vised text is set forth as follows: provided in paragraph (e) of this sec- § 317.345 Nutrition labeling of single-ingre- tion, a claim about the level of a nutri- dient, raw meat products that are not ent in a product in relation to the Ref- ground or chopped products described in erence Daily Intake (RDI) or Daily Ref- § 317.301. erence Value (DRV) established for (a)(1) Nutrition information on the major that nutrient (excluding total carbo- cuts of single-ingredient, raw meat products identified in § 317.344, including those that hydrate) in § 317.309(c), may only be have been previously frozen, is required, ei- made on the label or in labeling of the ther on their label or at their point-of-pur- product if: chase, unless exempted under § 317.400. If nu- (1) The claim uses one of the terms trition information is presented on the label, defined in this section in accordance it must be provided in accordance with with the definition for that term; § 317.309. If nutrition information is presented at the point-of-purchase, it must be (2) The claim is made in accordance provided in accordance with the provisions of with the general requirements for nu- this section. trient content claims in § 317.313; and (2) Nutrition information on single-ingre- (3) The product for which the claim is dient, raw meat products that are not ground made is labeled in accordance with or chopped meat products described in § 317.301 and are not major cuts of single-in- § 317.309. gredient, raw meat products identified in (b) ‘‘High’’ claims. (1) The terms § 317.344, including those that have been pre- ‘‘high,’’ ‘‘rich in,’’ or ‘‘excellent source viously frozen, may be provided at their of’’ may be used on the label or in la- point-of-purchase in accordance with the beling of products, except meal-type provisions of this section or on their label, in products as defined in § 317.313(l), and accordance with the provisions of § 317.309. main-dish products as defined in (3) A retailer may provide nutrition information at the point-of-purchase by various § 317.313(m) provided that the product methods, such as by posting a sign or by contains 20 percent or more of the RDI making the information readily available in or the DRV per reference amount cus- brochures, notebooks, or leaflet form in tomarily consumed. close proximity to the food. The nutrition la- (2) The terms defined in paragraph beling information may also be supple- (b)(1) of this section may be used on mented by a video, live demonstration, or other media. If a nutrition claim is made on the label or in labeling of a meal-type point-of-purchase materials, all of the for- product as defined in § 317.313(l), and mat and content requirements of § 317.309 main-dish product as defined in apply. However, if only nutrition informa- § 317.313(m) provided that:

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(i) The product contains a food that (i) The product contains at least 10 meets the definition of ‘‘high’’ in para- percent more of the RDI or the DRV graph (b)(1) of this section; and for protein, vitamins, minerals, dietary (ii) The label or labeling clearly iden- fiber, or potassium (expressed as a per- tifies the food that is the subject of the cent of the Daily Value) per reference claim (e.g., ‘‘the serving of broccoli in amount customarily consumed than an this meal is high in vitamin C’’). appropriate reference product as de- (c) ‘‘Good Source’’ claims. (1) The scribed in § 317.313(j)(1); and terms ‘‘good source,’’ ‘‘contains,’’ or (ii) As required in § 317.313(j)(2) for ‘‘provides’’ may be used on the label or relative claims: in labeling of products, except meal- (A) The identity of the reference type products as described in product and the percent (or fraction) § 317.313(l), and main-dish products as that the nutrient is greater relative to defined in § 317.313(m) provided that the the RDI or DRV are declared in imme- product contains 10 to 19 percent of the diate proximity to the most prominent RDI or the DRV per reference amount such claim (e.g., ‘‘contains 10 percent customarily consumed. more of the Daily Value for fiber than (2) The terms defined in paragraph ‘reference product’ ’’); and (c)(1) of this section may be used on the (B) Quantitative information com- label or in labeling of a meal-type paring the level of the nutrient in the product per labeled serving size with product as defined in § 317.313(l), and that of the reference product that it remain-dish product as defined in places is declared adjacent to the most § 317.313(m) provided that: prominent claim or to the nutrition in- (i) The product contains a food that formation (e.g., ‘‘fiber content of ‘ref- meets the definition of ‘‘good source’’ erence product’ is 1 g per serving; ‘this in paragraph (c)(1) of this section; and product’ contains 4 g per serving’’). (ii) The label or labeling clearly iden- (2) A relative claim using the terms tifies the food that is the subject of the ‘‘more’’ and ‘‘added’’ may be used on claim (e.g., ‘‘the serving of sweet pota- the label or in labeling to describe the toes in this meal is a good source of level of protein, vitamins, minerals, di- fiber’’). etary fiber, or potassium in meal-type (d) Fiber claims. (1) If a nutrient con- products as defined in § 317.313(l), and tent claim is made with respect to the main-dish products as defined in level of dietary fiber, i.e., that the § 317.313(m) provided that: product is high in fiber, a good source (i) The product contains at least 10 of fiber, or that the product contains percent more of the RDI or the DRV ‘‘more’’ fiber, and the product is not for protein, vitamins, minerals, dietary ‘‘low’’ in total fat as defined in fiber, or potassium (expressed as a per- § 317.362(b)(2) or, in the case of a meal- cent of the Daily Value) per 100 g of type product or a main-dish product, is product than an appropriate reference not ‘‘low’’ in total fat as defined in product as described in § 317.313(j)(1); § 317.362(b)(3), then the labeling shall and disclose the level of total fat per la- (ii) As required in § 317.313(j)(2) for beled serving size (e.g., ‘‘contains 12 relative claims: grams (g) of fat per serving’’); and (A) The identity of the reference (2) The disclosure shall appear in im- product and the percent (or fraction) mediate proximity to such claim and that the nutrient is greater relative to be in a type size no less than one-half the RDI or DRV are declared in imme- the size of the claim. diate proximity to the most prominent (e) ‘‘More’’ claims. (1) A relative claim such claim (e.g., ‘‘contains 10 percent using the terms ‘‘more’’ and ‘‘added’’ more of the Daily Value for fiber per 3 may be used on the label or in labeling ounces (oz) than does ‘reference prod- to describe the level of protein, vita- uct’ ’’), and mins, minerals, dietary fiber, or potas- (B) Quantitative information com- sium in a product, except meal-type paring the level of the nutrient in the products as defined in § 317.313(l), and meal-type product or a main-dish prod- main-dish products as defined in uct per specified weight with that of § 317.313(m) provided that: the reference product that it replaces

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is declared adjacent to the most promi- the most prominent such claim (e.g., nent claim or to the nutrition informa- ‘‘1⁄3 fewer calories and 50 percent less tion (e.g., ‘‘fiber content of ‘reference fat than the market leader’’); and product’ is 2 g per 3 oz; ‘this product’ (ii) Quantitative information com- contains 5 g per 3 oz’’). paring the level of calories and fat con- [60 FR 189, Jan. 3, 1995, as amended at 69 FR tent in the product per labeled serving 58802, Oct. 1, 2004] size with that of the reference product that it replaces is declared adjacent to § 317.355 [Reserved] the most prominent claim or to the nutrition information (e.g., ‘‘lite ‘this § 317.356 Nutrient content claims for product’—200 calories, 4 grams (g) fat; ‘‘light’’ or ‘‘lite.’’ regular ‘reference product’—300 cal- (a) General requirements. A claim ories, 8 g fat per serving’’); and using the terms ‘‘light’’ or ‘‘lite’’ to de- (iii) If the labeled product contains scribe a product may only be made on less than 40 calories or less than 3 g fat the label or in labeling of the product per reference amount customarily con- if: sumed, the percentage reduction for (1) The claim uses one of the terms that nutrient need not be declared. defined in this section in accordance (4) A ‘‘light’’ claim may not be made with the definition for that term; on a product for which the reference (2) The claim is made in accordance product meets the definition of ‘‘low with the general requirements for nu- fat’’ and ‘‘low calorie.’’ trient content claims in § 317.313; and (c)(1)(i) A product for which the ref- (3) The product for which the claim is erence product contains 40 calories or made is labeled in accordance with less and 3 g fat or less per reference § 317.309. (b) ‘‘Light’’ claims. The terms ‘‘light’’ amount customarily consumed may or ‘‘lite’’ may be used on the label or in use the terms ‘‘light’’ or ‘‘lite’’ without labeling of products, except meal-type further qualification if it is reduced by products as defined in § 317.313(l) and 50 percent or more in sodium content main-dish products as defined in compared to the reference product; and § 317.313(m), without further qualifica- (ii) As required in § 317.313(j)(2) for tion, provided that: relative claims: (1) If the product derives 50 percent (A) The identity of the reference or more of its calories from fat, its fat product and the percent (or fraction) content is reduced by 50 percent or that the sodium was reduced are de- more per reference amount custom- clared in immediate proximity to the arily consumed compared to an appro- most prominent such claim (e.g., ‘‘50 priate reference product as described in percent less sodium than the market § 317.313(j)(1); or leader’’); and (2) If the product derives less than 50 (B) Quantitative information com- percent of its calories from fat: paring the level of sodium per labeled (i) The number of calories is reduced serving size with that of the reference by at least one-third (331⁄3 percent) per product it replaces is declared adjacent reference amount customarily con- to the most prominent claim or to the sumed compared to an appropriate ref- nutrition information (e.g., ‘‘lite ‘this erence product as described in product’—500 milligrams (mg) sodium § 317.313(j)(1); or per serving; regular ‘reference prod- (ii) Its fat content is reduced by 50 uct’—1,000 mg sodium per serving’’). percent or more per reference amount (2)(i) A product for which the ref- customarily consumed compared to the erence product contains more than 40 appropriate reference product as de- calories or more than 3 g fat per ref- scribed in § 317.313(j)(1); and erence amount customarily consumed (3) As required in § 317.313(j)(2) for rel- may use the terms ‘‘light in sodium’’ ative claims: or ‘‘lite in sodium’’ if it is reduced by (i) The identity of the reference prod- 50 percent or more in sodium content uct and the percent (or fraction) that compared to the reference product, pro- the calories and the fat were reduced vided that ‘‘light’’ or ‘‘lite’’ is pre- are declared in immediate proximity to sented in immediate proximity with

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‘‘in sodium’’ and the entire term is pre- (3) The term ‘‘light’’ or ‘‘lite’’ may be sented in uniform type size, style, used in the brand name of a product to color, and prominence; and describe the sodium content, provided (ii) As required in § 317.313(j)(2) for that: relative claims: (i) The product is reduced by 50 per- (A) The identity of the reference cent or more in sodium content com- product and the percent (or fraction) pared to the reference product; that the sodium was reduced are de- (ii) A statement specifically stating clared in immediate proximity to the that the product is ‘‘light in sodium’’ most prominent such claim (e.g., ‘‘50 or ‘‘lite in sodium’’ appears: percent less sodium than the market (A) Contiguous to the brand name; leader’’); and and (B) Quantitative information com- (B) In uniform type size, style, color, paring the level of sodium per labeled and prominence as the product name; serving size with that of the reference and product it replaces is declared adjacent (iii) As required in § 317.313(j)(2) for to the most prominent claim or to the relative claims: nutrition information (e.g., or ‘‘lite (A) The identity of the reference ‘this product’—170 mg sodium per serv- product and the percent (or fraction) ing; regular ‘reference product’—350 mg that the sodium was reduced are de- per serving’’). clared in immediate proximity to the (3) Except for meal-type products as most prominent such claim; and defined in § 317.313(l) and main-dish (B) Quantitative information com- products as defined in § 317.313(m), a paring the level of sodium per labeled ‘‘light in sodium’’ claim may not be serving size with that of the reference made on a product for which the ref- product it replaces is declared adjacent erence product meets the definition of to the most prominent claim or to the ‘‘low in sodium.’’ nutrition information. (d)(1) The terms ‘‘light’’ or ‘‘lite’’ (e) Except as provided in paragraphs may be used on the label or in labeling (b) through (d) of this section, the of a meal-type product as defined in terms ‘‘light’’ or ‘‘lite’’ may not be § 317.313(l) and main-dish product as de- used to refer to a product that is not fined in § 317.313(m), provided that: reduced in fat by 50 percent, or, if ap- (i) The product meets the definition plicable, in calories by 1⁄3 or, when of: properly qualified, in sodium by 50 per- (A) ‘‘Low in calories’’ as defined in cent unless: § 317.360(b)(3); or (1) It describes some physical or (B) ‘‘Low in fat’’ as defined in organoleptic attribute of the product § 317.362(b)(3); and such as texture or color and the infor- (ii)(A) A statement appears on the mation (e.g., ‘‘light in color’’ or ‘‘light principal display panel that explains in texture’’) so stated, clearly conveys whether ‘‘light’’ is used to mean ‘‘low the nature of the product; and fat,’’ ‘‘low calories,’’ or both (e.g., (2) The attribute (e.g., ‘‘color’’ or ‘‘Light Delight, a low fat meal’’); and ‘‘texture’’) is in the same style, color, (B) The accompanying statement is and at least one-half the type size as no less than one-half the type size of the word ‘‘light’’ and in immediate the ‘‘light’’ or ‘‘lite’’ claim. proximity thereto. (2)(i) The terms ‘‘light in sodium’’ or (f) If a manufacturer can dem- ‘‘lite in sodium’’ may be used on the onstrate that the word ‘‘light’’ has label or in labeling of a meal-type been associated, through common use, product as defined in § 317.313(l) and with a particular product to reflect a main-dish product as defined in physical or organoleptic attribute to § 317.313(m), provided that the product the point where it has become part of meets the definition of ‘‘low in so- the statement of identity, such use of dium’’ as defined in § 317.361(b)(5)(i); the term ‘‘light’’ shall not be consid- and ered a nutrient content claim subject (ii) ‘‘Light’’ or ‘‘lite’’ and ‘‘in so- to the requirements in this part. dium’’ are presented in uniform type (g) The term ‘‘lightly salted’’ may be size, style, color, and prominence. used on a product to which has been

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added 50 percent less sodium than is § 317.313(l) and main-dish products as normally added to the reference prod- defined in § 317.313(m), provided that: uct as described in § 317.313(j)(1)(i)(B) (i)(A) The product has a reference and (j)(1)(ii)(B), provided that if the amount customarily consumed greater product is not ‘‘low in sodium’’ as de- than 30 grams (g) or greater than 2 ta- fined in § 317.361(b)(4), the statement blespoons (tbsp) and does not provide ‘‘not a low sodium food,’’ shall appear more than 40 calories per reference adjacent to the nutrition information amount customarily consumed; or and the information required to accom- (B) The product has a reference pany a relative claim shall appear on amount customarily consumed of 30 g the label or labeling as specified in or less or 2 tbsp or less and does not § 317.313(j)(2). provide more than 40 calories per reference amount customarily consumed [60 FR 189, Jan. 3, 1995, as amended at 69 FR and per 50 g (for dehydrated products 58802, Oct. 1, 2004] that must be reconstituted before typ- §§ 317.357–317.359 [Reserved] ical consumption with water or a diluent containing an insignificant § 317.360 Nutrient content claims for amount, as defined in § 317.309(f)(1), of calorie content. all nutrients per reference amount customarily consumed, the per-50-g cri- (a) General requirements. A claim terion refers to the ‘‘as prepared’’ about the calorie or sugar content of a form). product may only be made on the label (ii) If the product meets these condi- or in labeling of the product if: tions without the benefit of special (1) The claim uses one of the terms processing, alteration, formulation, or defined in this section in accordance reformulation to lower the caloric con- with the definition for that term; tent, it is labeled to clearly refer to all (2) The claim is made in accordance products of its type and not merely to with the general requirements for nu- the particular brand to which the label trient content claims in § 317.313; and attaches. (3) The product for which the claim is (3) The terms defined in paragraph made is labeled in accordance with (b)(2) of this section may be used on § 317.309. the label or in labeling of a meal-type (b) Calorie content claims. (1) The product as defined in § 317.313(l) and terms ‘‘calorie free,’’ ‘‘free of calories,’’ main-dish product as defined in ‘‘no calories,’’ ‘‘zero calories,’’ ‘‘with- § 317.313(m), provided that: out calories,’’ ‘‘trivial source of cal- (i) The product contains 120 calories ories,’’ ‘‘negligible source of calories,’’ or less per 100 g of product; and or ‘‘dietarily insignificant source of (ii) If the product meets this condi- calories’’ may be used on the label or tion without the benefit of special in labeling of products, provided that: processing, alteration, formulation, or (i) The product contains less than 5 reformulation to lower the calorie con- calories per reference amount custom- tent, it is labeled to clearly refer to all arily consumed and per labeled serving products of its type and not merely to size; and the particular brand to which it at- (ii) If the product meets this condi- taches. tion without the benefit of special (4) The terms ‘‘reduced calorie,’’ ‘‘reprocessing, alteration, formulation, or duced in calories,’’ ‘‘calorie reduced,’’ reformulation to lower the caloric con- ‘‘fewer calories,’’ ‘‘lower calorie,’’ or tent, it is labeled to clearly refer to all ‘‘lower in calories’’ may be used on the products of its type and not merely to label or in labeling of products, except the particular brand to which the label meal-type products as defined in attaches. § 317.313(l) and main-dish products as (2) The terms ‘‘low calorie,’’ ‘‘few cal- defined in § 317.313(m), provided that: ories,’’ ‘‘contains a small amount of (i) The product contains at least 25 calories,’’ ‘‘low source of calories,’’ or percent fewer calories per reference ‘‘low in calories’’ may be used on the amount customarily consumed than an label or in labeling of products, except appropriate reference product as de- meal-type products as defined in scribed in § 317.313(j)(1); and

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(ii) As required in § 317.313(j)(2) for (c) Sugar content claims. (1) Terms relative claims: such as ‘‘sugar free,’’ ‘‘free of sugar,’’ (A) The identity of the reference ‘‘no sugar,’’ ‘‘zero sugar,’’ ‘‘without product and the percent (or fraction) sugar,’’ ‘‘sugarless,’’ ‘‘trivial source of that the calories differ between the two sugar,’’ ‘‘negligible source of sugar,’’ or products are declared in immediate ‘‘dietarily insignificant source of proximity to the most prominent such sugar’’ may reasonably be expected to claim (e.g., lower calorie ‘product’— be regarded by consumers as terms ‘‘331⁄3 percent fewer calories than our that represent that the product con- regular ‘product’ ’’); and tains no sugars or sweeteners, e.g., (B) Quantitative information com- ‘‘sugar free,’’ or ‘‘no sugar,’’ as indi- paring the level of calories in the prod- cating a product which is low in cal- uct per labeled serving size with that of ories or significantly reduced in cal- the reference product that it replaces ories. Consequently, except as provided is declared adjacent to the most promi- in paragraph (c)(2) of this section, a nent claim or to the nutrition informa- product may not be labeled with such tion (e.g., ‘‘calorie content has been re- terms unless: duced from 150 to 100 calories per serv- (i) The product contains less than 0.5 ing’’). g of sugars, as defined in (iii) Claims described in paragraph § 317.309(c)(6)(ii), per reference amount customarily consumed and per labeled (b)(4) of this section may not be made serving size or, in the case of a meal- on the label or in labeling of products type product or a main-dish product, if the reference product meets the defi- less than 0.5 g of sugars per labeled nition for ‘‘low calorie.’’ serving size; (5) The terms defined in paragraph (ii) The product contains no ingre- (b)(4) of this section may be used on dient that is a sugar or that is gen- the label or in labeling of a meal-type erally understood by consumers to con- product as defined in § 317.313(l) and tain sugars unless the listing of the in- main-dish product as defined in gredient in the ingredients statement § 317.313(m), provided that: is followed by an asterisk that refers to (i) The product contains at least 25 the statement below the list of ingredi- percent fewer calories per 100 g of prod- ents, which states: ‘‘Adds a trivial uct than an appropriate reference prod- amount of sugar,’’ ‘‘adds a negligible uct as described in § 317.313(j)(1); and amount of sugar,’’ or ‘‘adds a dietarily (ii) As required in § 317.313(j)(2) for insignificant amount of sugar;’’ and relative claims: (iii)(A) It is labeled ‘‘low calorie’’ or (A) The identity of the reference ‘‘reduced calorie’’ or bears a relative product and the percent (or fraction) claim of special dietary usefulness la- that the calories differ between the two beled in compliance with paragraphs products are declared in immediate (b)(2), (b)(3), (b)(4), or (b)(5) of this sec- proximity to the most prominent such tion; or claim (e.g., ‘‘calorie reduced ‘product’, (B) Such term is immediately accom- 25% less calories per ounce (oz) (or 3 oz) panied, each time it is used, by either than our regular ‘product’ ’’); and the statement ‘‘not a reduced calorie (B) Quantitative information com- product,’’ ‘‘not a low calorie product,’’ paring the level of calories in the prod- or ‘‘not for weight control.’’ uct per specified weight with that of (2) The terms ‘‘no added sugar,’’ the reference product that it replaces ‘‘without added sugar,’’ or ‘‘no sugar is declared adjacent to the most promi- added’’ may be used only if: nent claim or to the nutrition informa- (i) No amount of sugars, as defined in tion (e.g., ‘‘calorie content has been re- § 317.309(c)(6)(ii), or any other ingre- duced from 110 calories per 3 oz to 80 dient that contains sugars that func- calories per 3 oz’’). tionally substitute for added sugars is (iii) Claims described in paragraph added during processing or packaging; (b)(5) of this section may not be made (ii) The product does not contain an on the label or in labeling of products ingredient containing added sugars if the reference product meets the defi- such as jam, jelly, or concentrated nition for ‘‘low calorie.’’ fruit juice;

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(iii) The sugars content has not been been lowered from 8 g to 6 g per serv- increased above the amount present in ing’’). the ingredients by some means such as (5) The terms defined in paragraph the use of enzymes, except where the (c)(4) of this section may be used on the intended functional effect of the proc- label or in labeling of a meal-type ess is not to increase the sugars con- product as defined in § 317.313(l) and tent of a product, and a functionally main-dish product as defined in insignificant increase in sugars results; § 317.313(m), provided that: (iv) The product that it resembles (i) The product contains at least 25 and for which it substitutes normally percent less sugars per 100 g of product contains added sugars; and than an appropriate reference product (v) The product bears a statement as described in § 317.313(j)(1); and that the product is not ‘‘low calorie’’ (ii) As required in § 317.313(j)(2) for or ‘‘calorie reduced’’ (unless the prod- relative claims: uct meets the requirements for a ‘‘low’’ (A) The identity of the reference or ‘‘reduced calorie’’ product) and that product and the percent (or fraction) directs consumers’ attention to the nu- that the sugars differ between the two trition panel for further information products are declared in immediate on sugar and calorie content. proximity to the most prominent such (3) Paragraph (c)(1) of this section claim (e.g., ‘‘reduced sugar ‘product’— shall not apply to a factual statement 25% less sugar than our regular ‘prod- that a product, including products in- uct’ ’’); and tended specifically for infants and chil- (B) Quantitative information com- dren less than 2 years of age, is un- paring the level of the nutrient in the sweetened or contains no added sweet- product per specified weight with that eners in the case of a product that con- of the reference product that it re- tains apparent substantial inherent places is declared adjacent to the most sugar content, e.g., juices. prominent claim or to the nutrition in- (4) The terms ‘‘reduced sugar,’’ ‘‘re- formation (e.g., ‘‘sugar content has duced in sugar,’’ ‘‘sugar reduced,’’ ‘‘less been reduced from 17 g per 3 oz to 13 g sugar,’’ ‘‘lower sugar,’’ or ‘‘lower in per 3 oz’’). sugar’’ may be used on the label or in labeling of products, except meal-type [60 FR 191, Jan. 3, 1995, as amended at 69 FR products as defined in § 317.313(l) and 58802, Oct. 1, 2004] main-dish products as defined in § 317.361 Nutrient content claims for § 317.313(m), provided that: the sodium content. (i) The product contains at least 25 percent less sugars per reference (a) General requirements. A claim amount customarily consumed than an about the level of sodium in a product appropriate reference product as de- may only be made on the label or in la- scribed in § 317.313(j)(1); and beling of the product if: (ii) As required in § 317.313(j)(2) for (1) The claim uses one of the terms relative claims: defined in this section in accordance (A) The identity of the reference with the definition for that term; product and the percent (or fraction) (2) The claim is made in accordance that the sugars differ between the two with the general requirements for nu- products are declared in immediate trient content claims in § 317.313; and proximity to the most prominent such (3) The product for which the claim is claim (e.g., ‘‘this product contains 25 made is labeled in accordance with percent less sugar than our regular § 317.309. product’’); and (b) Sodium content claims. (1) The (B) Quantitative information com- terms ‘‘sodium free,’’ ‘‘free of sodium,’’ paring the level of the sugar in the ‘‘no sodium,’’ ‘‘zero sodium,’’ ‘‘without product per labeled serving size with sodium,’’ ‘‘trivial source of sodium,’’ that of the reference product that it re- ‘‘negligible source of sodium,’’ or places is declared adjacent to the most ‘‘dietarily insignificant source of so- prominent claim or to the nutrition in- dium’’ may be used on the label or in formation (e.g., ‘‘sugar content has labeling of products, provided that:

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(i) The product contains less than 5 (3) The terms defined in paragraph milligrams (mg) of sodium per ref- (b)(2) of this section may be used on erence amount customarily consumed the label or in labeling of a meal-type and per labeled serving size or, in the product as defined in § 317.313(l) and case of a meal-type product or a main- main-dish product as defined in dish product, less than 5 mg of sodium § 317.313(m), provided that: per labeled serving size; (i) The product contains 35 mg or less (ii) The product contains no ingre- of sodium per 100 g of product; and dient that is sodium chloride or is gen- (ii) If the product meets this condi- erally understood by consumers to con- tion without the benefit of special tain sodium unless the listing of the in- processing, alteration, formulation, or gredient in the ingredients statement reformulation to lower the sodium con- is followed by an asterisk that refers to tent, it is labeled to clearly refer to all the statement below the list of ingredi- products of its type and not merely to ents, which states: ‘‘Adds a trivial the particular brand to which the label amount of sodium,’’ ‘‘adds a negligible attaches. amount of sodium’’ or ‘‘adds a dietarily (4) The terms ‘‘low sodium,’’ ‘‘low in insignificant amount of sodium’’; and sodium,’’ ‘‘little sodium,’’ ‘‘contains a (iii) If the product meets these condi- small amount of sodium,’’ or ‘‘low tions without the benefit of special source of sodium’’ may be used on the processing, alteration, formulation, or label and in labeling of products, ex- reformulation to lower the sodium concept meal-type products as defined in tent, it is labeled to clearly refer to all § 317.313(l) and main-dish products as products of its type and not merely to defined in § 317.313(m), provided that: the particular brand to which the label (i)(A) The product has a reference attaches. amount customarily consumed greater (2) The terms ‘‘very low sodium’’ or than 30 g or greater than 2 tbsp and ‘‘very low in sodium’’ may be used on contains 140 mg or less sodium per ref- the label or in labeling of products, ex- erence amount customarily consumed; cept meal-type products as defined in or § 317.313(l) and main-dish products as (B) The product has a reference defined in § 317.313(m), provided that: amount customarily consumed of 30 g (i)(A) The product has a reference or less or 2 tbsp or less and contains 140 amount customarily consumed greater mg or less sodium per reference than 30 grams (g) or greater than 2 ta- amount customarily consumed and per blespoons (tbsp) and contains 35 mg or 50 g (for dehydrated products that must less sodium per reference amount cus- be reconstituted before typical con- tomarily consumed; or sumption with water or a diluent con- (B) The product has a reference taining an insignificant amount, as de- amount customarily consumed of 30 g fined in § 317.309(f)(1), of all nutrients or less or 2 tbsp or less and contains 35 per reference amount customarily con- mg or less sodium per reference sumed, the per-50-g criterion refers to amount customarily consumed and per the ‘‘as prepared’’ form); and 50 g (for dehydrated products that must (ii) If the product meets these condi- be reconstituted before typical con- tions without the benefit of special sumption with water or a diluent con- processing, alteration, formulation, or taining an insignificant amount, as de- reformulation to lower the sodium confined in § 317.309(f)(1), of all nutrients tent, it is labeled to clearly refer to all per reference amount customarily con- products of its type and not merely to sumed, the per-50-g criterion refers to the particular brand to which the label the ‘‘as prepared’’ form); and attaches. (ii) If the product meets these condi- (5) The terms defined in paragraph tions without the benefit of special (b)(4) of this section may be used on processing, alteration, formulation, or the label or in labeling of a meal-type reformulation to lower the sodium con- product as defined in § 317.313(l) and tent, it is labeled to clearly refer to all main-dish product as defined in products of its type and not merely to § 317.313(m), provided that: the particular brand to which the label (i) The product contains 140 mg or attaches. less sodium per 100 g of product; and

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(ii) If the product meets these condi- (A) The identity of the reference tions without the benefit of special product and the percent (or fraction) processing, alteration, formulation, or that the sodium differs between the reformulation to lower the sodium con- two products are declared in imme- tent, it is labeled to clearly refer to all diate proximity to the most prominent products of its type and not merely to such claim (e.g., ‘‘reduced sodium the particular brand to which the label ‘product’—30% less sodium per 3 oz attaches. than our ‘regular product’ ’’); and (6) The terms ‘‘reduced sodium,’’ (B) Quantitative information com- ‘‘reduced in sodium,’’ ‘‘sodium re- paring the level of sodium in the prod- duced,’’ ‘‘less sodium,’’ ‘‘lower so- uct per specified weight with that of dium,’’ or ‘‘lower in sodium’’ may be the reference product that it replaces used on the label or in labeling of prod- is declared adjacent to the most promi- ucts, except meal-type products as de- nent claim or to the nutrition informa- fined in § 317.313(l) and main-dish prod- tion (e.g., ‘‘sodium content has been re- ucts as defined in § 317.313(m), provided duced from 220 mg per 3 oz to 150 mg that: per 3 oz’’). (i) The product contains at least 25 (iii) Claims described in paragraph percent less sodium per reference (b)(7) of this section may not be made amount customarily consumed than an on the label or in labeling of products appropriate reference product as de- if the nutrient content of the reference scribed in § 317.313(j)(1); and product meets the definition for ‘‘low (ii) As required in § 317.313(j)(2) for sodium.’’ relative claims: (c) The term ‘‘salt’’ is not synony- (A) The identity of the reference mous with ‘‘sodium.’’ Salt refers to so- product and the percent (or fraction) dium chloride. However, references to that the sodium differs between the salt content such as ‘‘unsalted,’’ ‘‘no two products are declared in imme- salt,’’ ‘‘no salt added’’ are potentially diate proximity to the most prominent misleading. such claim (e.g., ‘‘reduced sodium (1) The term ‘‘salt free’’ may be used ‘product’, 50 percent less sodium than on the label or in labeling of products regular ‘product’ ’’); and only if the product is ‘‘sodium free’’ as (B) Quantitative information com- defined in paragraph (b)(1) of this sec- paring the level of sodium in the prod- tion. uct per labeled serving size with that of (2) The terms ‘‘unsalted,’’ ‘‘without the reference product that it replaces added salt,’’ and ‘‘no salt added’’ may is declared adjacent to the most promi- be used on the label or in labeling of nent claim or to the nutrition informa- products only if: tion (e.g., ‘‘sodium content has been (i) No salt is added during processing; lowered from 300 to 150 mg per serv- (ii) The product that it resembles and ing’’). for which it substitutes is normally (iii) Claims described in paragraph processed with salt; and (b)(6) of this section may not be made (iii) If the product is not sodium free, on the label or in labeling of a product the statement, ‘‘not a sodium free if the nutrient content of the reference product’’ or ‘‘not for control of sodium product meets the definition for ‘‘low in the diet’’ appears adjacent to the nu- sodium.’’ trition information of the product (7) The terms defined in paragraph bearing the claim. (b)(6) of this section may be used on the label or in labeling of a meal-type (3) Paragraph (c)(2) of this section product as defined in § 317.313(l) and shall not apply to a factual statement main-dish product as defined in that a product intended specifically for § 317.313(m), provided that: infants and children less than 2 years (i) The product contains at least 25 of age is unsalted, provided such state- percent less sodium per 100 g of product ment refers to the taste of the product than an appropriate reference product and is not false or otherwise mis- as described in § 317.313(j)(1); and leading. (ii) As required in § 317.313(j)(2) for [60 FR 192, Jan. 3, 1995, as amended at 69 FR relative claims: 58802, Oct. 1, 2004]

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§ 317.362 Nutrient content claims for (i)(A) The product has a reference fat, fatty acids, and cholesterol con- amount customarily consumed greater tent. than 30 g or greater than 2 tablespoons (a) General requirements. A claim (tbsp) and contains 3 g or less of fat per about the level of fat, fatty acid, and reference amount customarily con- cholesterol in a product may only be sumed; or made on the label or in labeling of (B) The product has a reference products if: amount customarily consumed of 30 g (1) The claim uses one of the terms or less or 2 tbsp or less and contains 3 defined in this section in accordance g or less of fat per reference amount with the definition for that term; customarily consumed and per 50 g (for (2) The claim is made in accordance dehydrated products that must be re- with the general requirements for nu- constituted before typical consumption trient content claims in § 317.313; and with water or a diluent containing an (3) The product for which the claim is insignificant amount, as defined in made is labeled in accordance with § 317.309(f)(1), of all nutrients per ref- § 317.309. erence amount customarily consumed, (b) Fat content claims. (1) The terms the per-50-g criterion refers to the ‘‘as ‘‘fat free,’’ ‘‘free of fat,’’ ‘‘no fat,’’ prepared’’ form). ‘‘zero fat,’’ ‘‘without fat,’’ ‘‘nonfat,’’ (ii) If the product meets these condi- ‘‘trivial source of fat,’’ ‘‘negligible tions without the benefit of special source of fat,’’ or ‘‘dietarily insignifi- processing, alteration, formulation, or cant source of fat’’ may be used on the reformulation to lower the fat content, label or in labeling of products, pro- it is labeled to clearly refer to all prod- vided that: ucts of its type and not merely to the (i) The product contains less than 0.5 particular brand to which the label at- gram (g) of fat per reference amount taches. customarily consumed and per labeled (3) The terms defined in paragraph serving size or, in the case of a meal- (b)(2) of this section may be used on type product or a main-dish product, the label or in labeling of a meal-type less than 0.5 g of fat per labeled serving product as defined in § 317.313(l) and size; main-dish product as defined in (ii) The product contains no added in- § 317.313(m), provided that: gredient that is a fat or is generally understood by consumers to contain (i) The product contains 3 g or less of fat unless the listing of the ingredient total fat per 100 g of product and not in the ingredients statement is fol- more than 30 percent of calories from lowed by an asterisk that refers to the fat; and statement below the list of ingredients, (ii) If the product meets these condi- which states: ‘‘Adds a trivial amount of tions without the benefit of special fat,’’ ‘‘adds a negligible amount of fat,’’ processing, alteration, formulation, or or ‘‘adds a dietarily insignificant reformulation to lower the fat content, amount of fat’’; and it is labeled to clearly refer to all prod- (iii) If the product meets these condi- ucts of its type and not merely to the tions without the benefit of special particular brand to which the label at- processing, alteration, formulation, or taches. reformulation to lower the fat content, (4) The terms ‘‘reduced fat,’’ ‘‘re- it is labeled to clearly refer to all prod- duced in fat,’’ ‘‘fat reduced,’’ ‘‘less fat,’’ ucts of its type and not merely to the ‘‘lower fat,’’ or ‘‘lower in fat’’ may be particular brand to which the label at- used on the label or in labeling of prod- taches. ucts, except meal-type products as de- (2) The terms ‘‘low fat,’’ ‘‘low in fat,’’ fined in § 317.313(l) and main-dish prod- ‘‘contains a small amount of fat,’’ ‘‘low ucts as defined in § 317.313(m), provided source of fat,’’ or ‘‘little fat’’ may be that: used on the label and in labeling of (i) The product contains at least 25 products, except meal-type products as percent less fat per reference amount defined in § 317.313(l) and main-dish customarily consumed than an appro- products as defined in § 317.313(m), propriate reference product as described in vided that: § 317.313(j)(1); and

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(ii) As required in § 317.313(j)(2) for (6) The term ‘‘lll percent fat free’’ relative claims: may be used on the label or in labeling (A) The identity of the reference of products, provided that: product and the percent (or fraction) (i) The product meets the criteria for that the fat differs between the two ‘‘low fat’’ in paragraph (b)(2) or (b)(3) of products are declared in immediate this section; proximity to the most prominent such (ii) The percent declared and the claim (e.g., ‘‘reduced fat—50 percent words ‘‘fat free’’ are in uniform type less fat than our regular ‘product’ ’’); size; and and (iii) A ‘‘100 percent fat free’’ claim (B) Quantitative information com- may be made only on products that paring the level of fat in the product meet the criteria for ‘‘fat free’’ in para- per labeled serving size with that of the graph (b)(1) of this section, that con- reference product that it replaces is detain less than 0.5 g of fat per 100 g, and clared adjacent to the most prominent that contain no added fat. claim or to the nutrition information (iv) A synonym for ‘‘lll percent (e.g., ‘‘fat content has been reduced fat free’’ is ‘‘lll percent lean.’’ from 8 g to 4 g per serving’’). (c) Fatty acid content claims. (1) The (iii) Claims described in paragraph terms ‘‘saturated fat free,’’ ‘‘free of (b)(4) of this section may not be made saturated fat,’’ ‘‘no saturated fat,’’ ‘‘zero saturated fat,’’ ‘‘without satu- on the label or in labeling of a product rated fat,’’ ‘‘trivial source of saturated if the nutrient content of the reference fat,’’ ‘‘negligible source of saturated product meets the definition for ‘‘low fat,’’ or ‘‘dietarily insignificant source fat.’’ of saturated fat’’ may be used on the (5) The terms defined in paragraph label or in labeling of products, pro- (b)(4) of this section may be used on vided that: the label or in labeling of a meal-type (i) The product contains less than 0.5 product as defined in § 317.313(l) and g of saturated fat and less than 0.5 g main-dish product as defined in trans fatty acids per reference amount § 317.313(m), provided that: customarily consumed and per labeled (i) The product contains at least 25 serving size or, in the case of a meal- percent less fat per 100 g of product type product or a main-dish product, than an appropriate reference product less than 0.5 g of saturated fat and less as described in § 317.313(j)(1); and than 0.5 g trans fatty acids per labeled (ii) As required in § 317.313(j)(2) for serving size; relative claims: (ii) The product contains no ingre- (A) The identity of the reference dient that is generally understood by product and the percent (or fraction) consumers to contain saturated fat un- that the fat differs between the two less the listing of the ingredient in the products are declared in immediate ingredients statement is followed by an proximity to the most prominent such asterisk that refers to the statement claim (e.g., ‘‘reduced fat ‘product’, 33 below the list of ingredients, which percent less fat per 3 oz than our reg- states: ‘‘Adds a trivial amount of satu- ular ‘product’ ’’); and rated fat,’’ ‘‘adds a negligible amount (B) Quantitative information com- of saturated fat,’’ or ‘‘adds a dietarily paring the level of fat in the product insignificant amount of saturated fat;’’ per specified weight with that of the and reference product that it replaces is de- (iii) If the product meets these condi- clared adjacent to the most prominent tions without the benefit of special such claim or to the nutrition informa- processing, alteration, formulation, or tion (e.g., ‘‘fat content has been re- reformulation to lower saturated fat duced from 8 g per 3 oz to 5 g per 3 oz’’). content, it is labeled to clearly refer to (iii) Claims described in paragraph all products of its type and not merely (b)(5) of this section may not be made to the particular brand to which the on the label or in labeling of a product label attaches. if the nutrient content of the reference (2) The terms ‘‘low in saturated fat,’’ product meets the definition for ‘‘low ‘‘low saturated fat,’’ ‘‘contains a small fat.’’ amount of saturated fat,’’ ‘‘low source

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of saturated fat,’’ or ‘‘a little saturated ‘product’, contains 50 percent less satu- fat’’ may be used on the label or in la- rated fat than the national average for beling of products, except meal-type ‘product’ ’’); and products as defined in § 317.313(l) and (B) Quantitative information com- main-dish products as defined in paring the level of saturated fat in the § 317.313(m), provided that: product per labeled serving size with (i) The product contains 1 g or less of that of the reference product that it re- saturated fat per reference amount cus- places is declared adjacent to the most tomarily consumed and not more than prominent claim or to the nutrition in- 15 percent of calories from saturated formation (e.g., ‘‘saturated fat reduced fat; and from 3 g to 1.5 g per serving’’). (ii) If the product meets these condi- (iii) Claims described in paragraph tions without benefit of special proc- (c)(4) of this section may not be made essing, alteration, formulation, or re- on the label or in labeling of a product formulation to lower saturated fat con- if the nutrient content of the reference tent, it is labeled to clearly refer to all product meets the definition for ‘‘low products of its type and not merely to saturated fat.’’ the particular brand to which the label (5) The terms defined in paragraph attaches. (c)(4) of this section may be used on the (3) The terms defined in paragraph label or in labeling of a meal-type (c)(2) of this section may be used on the product as defined in § 317.313(l) and label or in labeling of a meal-type main-dish product as defined in product as defined in § 317.313(l) and § 317.313(m), provided that: main-dish product as defined in § 317.313(m), provided that: (i) The product contains at least 25 (i) The product contains 1 g or less of percent less saturated fat per 100 g of saturated fat per 100 g and less than 10 product than an appropriate reference percent calories from saturated fat; product as described in § 317.313(j)(1); and and (ii) If the product meets these condi- (ii) As required in § 317.313(j)(2) for tions without the benefit of special relative claims: processing, alteration, formulation, or (A) The identity of the reference reformulation to lower saturated fat product and the percent (or fraction) content, it is labeled to clearly refer to that the saturated fat differs between all products of its type and not merely the two products are declared in imme- to the particular brand to which the diate proximity to the most prominent label attaches. such claim (e.g., ‘‘reduced saturated fat (4) The terms ‘‘reduced saturated ‘product’,’’ ‘‘50 percent less saturated fat,’’ ‘‘reduced in saturated fat,’’ fat than our regular ‘product’ ’’); and ‘‘saturated fat reduced,’’ ‘‘less satu- (B) Quantitative information com- rated fat,’’ ‘‘lower saturated fat,’’ or paring the level of saturated fat in the ‘‘lower in saturated fat’’ may be used product per specified weight with that on the label or in labeling of products, of the reference product that it re- except meal-type products as defined in places is declared adjacent to the most § 317.313(l) and main-dish products as prominent claim or to the nutrition in- defined in § 317.313(m), provided that: formation (e.g., ‘‘saturated fat content (i) The product contains at least 25 has been reduced from 2.5 g per 3 oz to percent less saturated fat per reference 1.5 g per 3 oz’’). amount customarily consumed than an (iii) Claims described in paragraph appropriate reference product as de- (c)(5) of this section may not be made scribed in § 317.313(j)(1); and on the label or in labeling of a product (ii) As required in § 317.313(j)(2) for if the nutrient content of the reference relative claims: product meets the definition for ‘‘low (A) The identity of the reference saturated fat.’’ product and the percent (or fraction) (d) Cholesterol content claims. (1) The that the saturated fat differs between terms ‘‘cholesterol free,’’ ‘‘free of cho- the two products are declared in imme- lesterol,’’ ‘‘zero cholesterol,’’ ‘‘without diate proximity to the most prominent cholesterol,’’ ‘‘no cholesterol,’’ ‘‘trivial such claim (e.g., ‘‘reduced saturated fat source of cholesterol,’’ ‘‘negligible

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source of cholesterol,’’ or ‘‘dietarily in- (B) Quantitative information com- significant source of cholesterol’’ may paring the level of cholesterol in the be used on the label or in labeling of product per labeled serving size with products, provided that: that of the reference product that it re- (i) The product contains less than 2 places is declared adjacent to the most milligrams (mg) of cholesterol per ref- prominent claim or to the nutrition in- erence amount customarily consumed formation (e.g., ‘‘contains no choles- and per labeled serving size or, in the terol compared with 30 mg in one serv- case of a meal-type product as defined ing of ‘reference product’ ’’). in § 317.313(l) and main-dish product as (2) The terms ‘‘low in cholesterol,’’ defined in § 317.313(m), less than 2 mg of ‘‘low cholesterol,’’ ‘‘contains a small cholesterol per labeled serving size; amount of cholesterol,’’ ‘‘low source of (ii) The product contains no ingre- cholesterol,’’ or ‘‘little cholesterol’’ dient that is generally understood by may be used on the label or in labeling consumers to contain cholesterol, unof products, except meal-type products less the listing of the ingredient in the as defined in § 317.313(l) and main-dish ingredients statement is followed by an products as defined in § 317.313(m), pro- asterisk that refers to the statement vided that: below the list of ingredients, which (i)(A) If the product has a reference states: ‘‘Adds a trivial amount of cho- amount customarily consumed greater lesterol,’’ ‘‘adds a negligible amount of than 30 g or greater than 2 tbsp: cholesterol,’’ or ‘‘adds a dietarily insig- (1) The product contains 20 mg or less nificant amount of cholesterol’’; of cholesterol per reference amount customarily consumed; and (iii) The product contains 2 g or less (2) The product contains 2 g or less of of saturated fat per reference amount saturated fat per reference amount cus- customarily consumed or, in the case tomarily consumed; or of a meal-type product as defined in (B) If the product has a reference § 317.313(l) and main-dish product as de- amount customarily consumed of 30 g fined in § 317.313(m), 2 g or less of satu- or less or 2 tbsp or less: rated fat per labeled serving size; and (1) The product contains 20 mg or less (iv) If the product meets these condi- of cholesterol per reference amount tions without the benefit of special customarily consumed and per 50 g (for processing, alteration, formulation, or dehydrated products that must be re- reformulation to lower cholesterol con- constituted before typical consumption tent, it is labeled to clearly refer to all with water or a diluent containing an products of its type and not merely to insignificant amount, as defined in the particular brand to which it at- § 317.309(f)(1), of all nutrients per ref- taches; or erence amount customarily consumed, (v) If the product meets these condi- the per-50-g criterion refers to the ‘‘as tions only as a result of special proc- prepared’’ form); and essing, alteration, formulation, or re- (2) The product contains 2 g or less of formulation, the amount of cholesterol saturated fat per reference amount cus- is reduced by 25 percent or more from tomarily consumed. the reference product it replaces as de- (ii) If the product meets these condi- scribed in § 317.313(j)(1) and for which it tions without the benefit of special substitutes as described in § 317.313(d) processing, alteration, formulation, or that has a significant (e.g., 5 percent or reformulation to lower cholesterol con- more of a national or regional market) tent, it is labeled to clearly refer to all market share. As required in products of its type and not merely to § 317.313(j)(2) for relative claims: the particular brand to which the label (A) The identity of the reference attaches; or product and the percent (or fraction) (iii) If the product contains 20 mg or that the cholesterol was reduced are less of cholesterol only as a result of declared in immediate proximity to the special processing, alteration, formula- most prominent such claim (e.g., ‘‘cho- tion, or reformulation, the amount of lesterol free ‘product’, contains 100 per- cholesterol is reduced by 25 percent or cent less cholesterol than ‘reference more from the reference product it re- product’ ’’); and places as described in § 317.313(j)(1) and

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for which it substitutes as described in percent or more of a national or re- § 317.313(d) that has a significant (e.g., 5 gional market) market share; percent or more of a national or re- (ii) The product contains 2 g or less gional market) market share. As re- of saturated fat per reference amount quired in § 317.313(j)(2) for relative customarily consumed; and claims: (iii) As required in § 317.313(j)(2) for (A) The identity of the reference relative claims: product and the percent (or fraction) (A) The identity of the reference that the cholesterol has been reduced product and the percent (or fraction) are declared in immediate proximity to that the cholesterol has been reduced the most prominent such claim (e.g., are declared in immediate proximity to ‘‘low cholesterol ‘product’, contains 85 the most prominent such claim (e.g., percent less cholesterol than our reg- ‘‘25 percent less cholesterol than ‘ref- ular ‘product’ ’’); and erence product’ ’’); and (B) Quantitative information com- (B) Quantitative information comparing the level of cholesterol in the paring the level of cholesterol in the product per labeled serving size with product per labeled serving size with that of the reference product that it re- that of the reference product that it replaces is declared adjacent to the most places is declared adjacent to the most prominent claim or to the nutrition in- prominent claim or to the nutrition information (e.g., ‘‘cholesterol lowered formation (e.g., ‘‘cholesterol lowered from 30 mg to 5 mg per serving’’). from 55 mg to 30 mg per serving’’). (3) The terms defined in paragraph (iv) Claims described in paragraph (d)(2) of this section may be used on (d)(4) of this section may not be made the label or in labeling of a meal-type on the label or in labeling of a product product as defined in § 317.313(l) and if the nutrient content of the reference main-dish product as defined in product meets the definition for ‘‘low § 317.313(m), provided that: cholesterol.’’ (i) The product contains 20 mg or less of cholesterol per 100 g of product; (5) The terms defined in paragraph (ii) The product contains 2 g or less (d)(4) of this section may be used on of saturated fat per 100 g of product; the label or in labeling of a meal-type and product as defined in § 317.313(l) and (iii) If the product meets these condi- main-dish product as defined in tions without the benefit of special § 317.313(m), provided that: processing, alteration, formulation, or (i) The product has been specifically reformulation to lower cholesterol con- formulated, altered, or processed to re- tent, it is labeled to clearly refer to all duce its cholesterol by 25 percent or products of its type and not merely to more from the reference product it re- the particular brand to which the label places as described in § 317.313(j)(1) and attaches. for which it substitutes as described in (4) The terms ‘‘reduced cholesterol,’’ § 317.313(d) that has a significant (e.g., 5 ‘‘reduced in cholesterol,’’ ‘‘cholesterol percent or more of a national or re- reduced,’’ ‘‘less cholesterol,’’ ‘‘lower gional market) market share; cholesterol,’’ or ‘‘lower in cholesterol’’ (ii) The product contains 2 g or less may be used on the label or in labeling of saturated fat per 100 g of product; of products or products that substitute and for those products as specified in (iii) As required in § 317.313(j)(2) for § 317.313(d), excluding meal-type prod- relative claims: ucts as defined in § 317.313(l) and main- (A) The identity of the reference dish products as defined in § 317.313(m), product and the percent (or fraction) provided that: that the cholesterol has been reduced (i) The product has been specifically are declared in immediate proximity to formulated, altered, or processed to re- the most prominent such claim (e.g., duce its cholesterol by 25 percent or ‘‘25% less cholesterol than ‘reference more from the reference product it re- product’ ’’); and places as described in § 317.313(j)(1) and (B) Quantitative information com- for which it substitutes as described in paring the level of cholesterol in the § 317.313(d) that has a significant (e.g., 5 product per specified weight with that

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of the reference product that it re- the same color background, as the statement places is declared adjacent to the most of the lean percentage. prominent claim or to the nutrition information (e.g., ‘‘cholesterol content * * * * * has been reduced from 35 mg per 3 oz to 25 mg per 3 oz). § 317.363 Nutrient content claims for (iv) Claims described in paragraph ‘‘healthy.’’ (d)(5) of this section may not be made (a) The term ‘‘healthy,’’ or any other on the label or in labeling of a product derivative of the term ‘‘health,’’ may if the nutrient content of the reference be used on the labeling of any meat or product meets the definition for ‘‘low meat food product, provided that the cholesterol.’’ product is labeled in accordance with (e) ‘‘Lean’’ and ‘‘Extra Lean’’ claims. § 317.309 and § 317.313. (1) The term ‘‘lean’’ may be used on the (b)(1) The product shall meet the relabel or in labeling of a product, pro- quirements for ‘‘low fat’’ and ‘‘low vided that the product contains less saturated fat,’’ as defined in § 317.362, than 10 g of fat, 4.5 g or less of satu- except that single-ingredient, raw rated fat, and less than 95 mg of choles- products may meet the total fat and terol per 100 g of product and per ref- saturated fat criteria for ‘‘extra lean’’ erence amount customarily consumed in § 317.362. for individual foods, and per 100 g of (2) The product shall not contain product and per labeled serving size for more than 60 milligrams (mg) of cho- meal-type products as defined in lesterol per reference amount custom- § 317.313(l) and main-dish products as arily consumed, per labeled serving defined in § 317.313(m). size, and, only for foods with reference (2) The term ‘‘extra lean’’ may be amounts customarily consumed of 30 used on the label or in labeling of a grams (g) or less or 2 tablespoons (tbsp) product, provided that the product con- or less, per 50 g, and, for dehydrated tains less than 5 g of fat, less than 2 g products that must be reconstituted of saturated fat, and less than 95 mg of with water or a diluent containing an cholesterol per 100 g of product and per insignificant amount, as defined in reference amount customarily con- § 317.309(f)(1), of all nutrients, the per- sumed for individual foods, and per 100 50-g criterion refers to the prepared g of product and per labeled serving form, except that: size for meal-type products as defined (i) A main-dish product, as defined in in § 317.313(l) and main-dish products as § 317.313(m), and a meal-type product, defined in § 317.313(m). as defined in § 317.313(l), and including [60 FR 193, Jan. 3, 1995, as amended at 69 FR meal-type products that weigh more 58802, Oct. 1, 2004] than 12 ounces (oz) per serving (container), shall not contain more than 90 EFFECTIVE DATE NOTE: At 75 FR 82165, Dec. 29, 2010, § 317.362 was amended by adding a mg of cholesterol per labeled serving new paragraph (f), effective Jan. 1, 2012. At 76 size; and FR 76890, Dec. 9, 2011, the effectiveness was (ii) Single-ingredient, raw products delayed until Mar. 1, 2012. For the conven- may meet the cholesterol criterion for ience of the user, the added text is set forth ‘‘extra lean’’in § 317.362. as follows: (3) The product shall not contain § 317.362 Nutrient content claims for fat, more than 480 mg of sodium per ref- fatty acids, and cholesterol content. erence amount customarily consumed, per labeled serving size, and, only for * * * * * foods with reference amounts customarily consumed of 30 g or less or 2 tbsp (f) A statement of the lean percentage may or less, per 50 g, and, for dehydrated be used on the label or in labeling of ground products that must be reconstituted or chopped meat products described in with water or a diluent containing an § 317.301 when the product does not meet the criteria for ‘‘low fat,’’ defined in insignificant amount, as defined in § 317.362(b)(2), provided that a statement of § 317.309(f)(1), of all nutrients, the per- the fat percentage is contiguous to and in 50-g criterion refers to the prepared lettering of the same color, size, type, and on form, except that:

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(i) A main-dish product, as defined in (1) Labeling applications for a new § 317.313(m), and a meal-type product, (heretofore unauthorized) nutrient con- as defined in § 317.313(l), and including tent claim, meal-type products that weigh more (2) Labeling applications for a syn- than 12 oz per serving (container), shall onymous term (i.e., one that is con- not contain more than 600 mg of so- sistent with a term defined by regula- dium per labeled serving size;1 and tion) for characterizing the level of a (ii) The requirements of this para- nutrient, and graph (b)(3) do not apply to single-in- (3) Labeling applications for the use gredient, raw products. of an implied claim in a brand name. (4) The product shall contain 10 per- (c) Labeling applications and sup- cent or more of the Reference Daily In- porting documentation to be filed take or Daily Reference Value as de- under this section shall be submitted fined in § 317.309 for vitamin A, vitamin in quadruplicate, except that the sup- C, iron, calcium, protein, or fiber per porting documentation may be sub- reference amount customarily con- mitted on a computer disc copy. If any sumed prior to any nutrient addition, part of the material submitted is in a except that: foreign language, it shall be accom- (i) A main-dish product, as defined in panied by an accurate and complete § 317.313(m), and including main-dish English translation. The labeling appli- products that weigh less than 10 oz per cation shall state the applicant’s post serving (container), shall meet the office address. level for two of the nutrients per la- (d) Pertinent information will be beled serving size; and considered as part of an application on (ii) A meal-type product, as defined the basis of specific reference to such in § 317.313(l), shall meet the level for information submitted to and retained three of the nutrients per labeled serv- in the files of the Food Safety and In- ing size. spection Service. However, any reference to unpublished information fur- [59 FR 24228, May 10, 1994, as amended at 60 nished by a person other than the ap- FR 196, Jan. 3, 1995; 63 FR 7281, Feb. 13, 1998; plicant will not be considered unless 64 FR 72492, Dec. 28, 1999; 68 FR 463, Jan. 6, 2003; 69 FR 58802, Oct. 1, 2004; 71 FR 1686, Jan. use of such information is authorized 11, 2006] (with the understanding that such information may in whole or part be sub- §§ 317.364–317.368 [Reserved] ject to release to the public) in a written statement signed by the person § 317.369 Labeling applications for nu- who submitted it. Any reference to trient content claims. published information should be ac- (a) This section pertains to labeling companied by reprints or photostatic applications for claims, express or im- copies of such references. plied, that characterize the level of any (e) If nonclinical laboratory studies nutrient required to be on the label or accompany a labeling application, the in labeling of product by this subpart. applicant shall include, with respect to (b) Labeling applications included in each nonclinical study included with this section are: the application, either a statement that the study has been, or will be, conducted in compliance with the good 1 This regulation previously provided that, after January 1, 2006, individual meat prod- laboratory practice regulations as set ucts bearing the claim ‘‘healthy’’ (or any de- forth in part 58 of chapter 1, title 21, or, rivative of the term ‘‘health’’) must contain if any such study was not conducted in no more than 360 mg of sodium and that compliance with such regulations, a meal-type products bearing the claim brief statement of the reason for the ‘‘healthy’’ (or any other derivative of the noncompliance. term ‘‘health’’) must contain no more than (f) If clinical investigations accom- 600 mg of sodium. Implementation of these pany a labeling application, the appli- sodium level requirements for products bearing the claim ‘‘healthy’’ (or any derivative of cant shall include, with respect to each the term ‘‘health’’) has been deferred indefi- clinical investigation included with the nitely due to technological barriers and con- application, either a statement that sumer preferences. the investigation was conducted in

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compliance with the requirements for shall provide examples of the nutrient con- institutional review set forth in part 56 tent claim as it will be used on labels or la- of chapter 1, title 21, or was not subject beling, as well as the types of products on to such requirements in accordance which the claim will be used. The statement shall also specify the level at which the nu- with § 56.194 or § 56.105, and that it was trient must be present or what other condi- conducted in compliance with the re- tions concerning the product must be met quirements for informed consents set for the appropriate use of the term in labels forth in part 50 of chapter 1, title 21. or labeling, as well as any factors that would (g) The availability for public disclo- make the use of the term inappropriate. sure of labeling applications, along (ii) A detailed explanation supported by with supporting documentation, sub- any necessary data of why use of the food mitted to the Agency under this sec- component characterized by the claim is of tion will be governed by the rules spec- importance in human nutrition by virtue of ified in subchapter D, title 9. its presence or absence at the levels that such claim would describe. This explanation (h) The data specified under this sec- shall also state what nutritional benefit to tion to accompany a labeling applica- the public will derive from use of the claim tion shall be submitted on separate as proposed and why such benefit is not sheets, suitably identified. If such data available through the use of existing terms has already been submitted with an defined by regulation. If the claim is in- earlier labeling application from the tended for a specific group within the popu- applicant, the present labeling applica- lation, the analysis shall specifically address tion must provide the data. nutritional needs of such group, and sci- (i) The labeling application must be entific data sufficient for such purpose, and data and information to the extent necessary signed by the applicant or by his or her to demonstrate that consumers can be ex- attorney or agent, or (if a corporation) pected to understand the meaning of the by an authorized official. term under the proposed conditions of use. (j) The labeling application shall in- (iii) Analytical data that demonstrates the clude a statement signed by the person amount of the nutrient that is present in the responsible for the labeling applica- products for which the claim is intended. tion, that to the best of his or her The assays should be performed on rep- knowledge, it is a representative and resentative samples in accordance with balanced submission that includes un- 317.309(h). If no USDA or AOAC methods are favorable information, as well as favor- available, the applicant shall submit the assay method used, and data establishing the able information, known to him or her validity of the method for assaying the nu- pertinent to the evaluation of the la- trient in the particular food. The validation beling application. data shall include a statistical analysis of (k)(1) Labeling applications for a new the analytical and product variability. nutrient content claim shall be accom- (iv) A detailed analysis of the potential ef- panied by the following data which fect of the use of the proposed claim on food shall be submitted in the following consumption, and any corresponding changes form to the Director, Food Labeling in nutrient intake. The analysis shall spe- Division, Regulatory Programs, Food cifically address the intake of nutrients that Safety and Inspection Service, Wash- have beneficial and negative consequences in the total diet. If the claim is intended for a ington, DC 20250. specific group within the population, the llllllllllllllllllllllll analysis shall specifically address the die- (Date) tary practices of such group, and shall include data sufficient to demonstrate that the The undersigned, lllll, submits this dietary analysis is representative of such labeling application pursuant to 9 CFR 317.369 with respect to (statement of the group. claim and its proposed use). Yours very truly, Attached hereto, in quadruplicate, or on a Applicant lllllllllllllll computer disc copy, and constituting a part of this labeling application, are the fol- By lllllllllllllllllll lowing: (Indicate authority) (i) A statement identifying the nutrient (2) Upon receipt of the labeling appli- content claim and the nutrient that the term is intended to characterize with respect cation and supporting documentation, to the level of such nutrient. The statement the applicant shall be notified, in writ- shall address why the use of the term as pro- ing, of the date on which the labeling posed will not be misleading. The statement application was received. Such notice

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shall inform the applicant that the la- (5) If the labeling application is not beling application is undergoing Agen- summarily denied by the Adminis- cy review and that the applicant shall trator, the Administrator shall publish subsequently be notified of the Agen- in the FEDERAL REGISTER a proposed cy’s decision to consider for further re- rule to amend the regulations to au- view or deny the labeling application. thorize the use of the nutrient content (3) Upon review of the labeling appli- claim. The proposal shall also summa- cation and supporting documentation, rize the labeling application, including the Agency shall notify the applicant, where the supporting documentation in writing, that the labeling applica- can be reviewed. The Administrator’s tion is either being considered for fur- proposed rule shall seek comment from ther review or that it has been sum- consumers, the industry, consumer and marily denied by the Administrator. industry groups, and other interested (4) If the labeling application is sum- persons on the labeling application and marily denied by the Administrator, the use of the proposed nutrient con- the written notification shall state the tent claim. After public comment has reasons therefor, including why the been received and reviewed by the Agency has determined that the pro- Agency, the Administrator shall make posed nutrient content claim is false or a determination on whether the pro- misleading. The notification letter posed nutrient content claim shall be shall inform the applicant that the ap- approved for use on the labeling of plicant may submit a written state- meat and meat food products. ment by way of answer to the notifica- (i) If the claim is denied by the Ad- tion, and that the applicant shall have ministrator, the Agency shall notify the right to request a hearing with re- the applicant, in writing, of the basis spect to the merits or validity of the for the denial, including the reason Administrator’s decision to deny the why the claim on the labeling was de- use of the proposed nutrient content termined by the Agency to be false or claim. misleading. The notification letter (i) If the applicant fails to accept the shall also inform the applicant that the determination of the Administrator applicant may submit a written state- and files an answer and requests a ment by way of answer to the notifica- hearing, and the Administrator, after tion, and that the applicant shall have review of the answer, determines the the right to request a hearing with re- initial determination to be correct, the spect to the merits or validity of the Administrator shall file with the Hear- Administrator’s decision to deny the ing Clerk of the Department the notifi- use of the proposed nutrient content cation, answer, and the request for a claim. hearing, which shall constitute the (A) If the applicant fails to accept complaint and answer in the pro- the determination of the Adminis- ceeding, which shall thereafter be con- trator and files an answer and requests ducted in accordance with the Depart- a hearing, and the Administrator, after ment’s Uniform Rules of Practice. review of the answer, determines the (ii) The hearing shall be conducted initial determination to be correct, the before an administrative law judge Administrator shall file with the Hear- with the opportunity for appeal to the ing Clerk of the Department the notifi- Department’s Judicial Officer, who cation, answer, and the request for a shall make the final determination for hearing, which shall constitute the the Secretary. Any such determination complaint and answer in the pro- by the Secretary shall be conclusive ceeding, which shall thereafter be con- unless, within 30 days after receipt of ducted in accordance with the Depart- notice of such final determination, the ment’s Uniform Rules of Practice. applicant appeals to the United States (B) The hearing shall be conducted Court of Appeals for the circuit in before an administrative law judge which the applicant has its principal with the opportunity for appeal to the place of business or to the United Department’s Judicial Officer, who States Court of Appeals for the District shall make final determination for the of Columbia Circuit. Secretary. Any such determination by

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the Secretary shall be conclusive un- the analysis shall specifically address nutri- less, within 30 days after receipt of the tional needs of such group, scientific data notice of such final determination, the sufficient for such purpose, and data and in- applicant appeals to the United States formation to the extent necessary to dem- Court of Appeals for the circuit in onstrate that consumers can be expected to understand the meaning of the term under which the applicant has its principal the proposed conditions of use. place of business or to the United States Court of Appeals for the District Yours very truly, of Columbia Circuit. Applicant lllllllllllllll (ii) If the claim is approved, the By lllllllllllllllllll Agency shall notify the applicant, in (Indicate authority) writing, and shall also publish in the (2) Upon receipt of the labeling appli- FEDERAL REGISTER a final rule amend- cation and supporting documentation, ing the regulations to authorize the the applicant shall be notified, in writ- use of the claim. ing, of the date on which the labeling (l)(1) Labeling applications for a syn- application was received. Such notice onymous term shall be accompanied by shall inform the applicant that the la- the following data which shall be submitted in the following form to the Di- beling application is undergoing Agen- rector, Food Labeling Division, Regu- cy review and that the applicant shall latory Programs, Food Safety and In- subsequently be notified of the Agen- spection Service, Washington, DC 20250: cy’s decision to consider for further review or deny the labeling application. llllllllllllllllllllllll (3) Upon review of the labeling appli- (Date) cation and supporting documentation, The undersigned, llllll submits this the Agency shall notify the applicant, labeling application pursuant to 9 CFR in writing, that the labeling applica- 317.369 with respect to (statement of the synonymous term and its proposed use in a nu- tion is either being considered for fur- trient content claim that is consistent with ther review or that it has been sum- an existing term that has been defined under marily denied by the Administrator. subpart B of part 317). (4) If the labeling application is sum- Attached hereto, in quadruplicate, or on a marily denied by the Administrator, computer disc copy, and constituting a part the written notification shall state the of this labeling application, are the following: reasons therefor, including why the (i) A statement identifying the synony- Agency has determined that the pro- mous term, the existing term defined by a posed synonymous term is false or mis- regulation with which the synonymous term leading. The notification letter shall is claimed to be consistent, and the nutrient inform the applicant that the applicant that the term is intended to characterize the may submit a written statement by level of. The statement shall address why the way of answer to the notification, and use of the synonymous term as proposed will not be misleading. The statement shall pro- that the applicant shall have the right vide examples of the nutrient content claim to request a hearing with respect to as it will be used on labels or labeling, as the merits or validity of the Adminis- well as the types of products on which the trator’s decision to deny the use of the claim will be used. The statement shall also proposed synonymous term. specify whether any limitations not applica- (i) If the applicant fails to accept the ble to the use of the defined term are in- determination of the Administrator tended to apply to the use of the synonymous term. and files an answer and requests a (ii) A detailed explanation supported by hearing, and the Administrator, after any necessary data of why use of the pro- review of the answer, determines the posed term is requested, including whether initial determination to be correct, the the existing defined term is inadequate for Administrator shall file with the Hear- the purpose of effectively characterizing the ing Clerk of the Department the notifi- level of a nutrient. This explanation shall cation, answer, and the request for a also state what nutritional benefit to the hearing, which shall constitute the public will derive from use of the claim as proposed, and why such benefit is not avail- complaint and answer in the pro- able through the use of existing terms de- ceeding, which shall thereafter be confined by regulation. If the claim is intended ducted in accordance with the Depart- for a specific group within the population, ment’s Uniform Rules of Practice.

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(ii) The hearing shall be conducted (ii) A detailed explanation supported by before an administrative law judge any necessary data of why use of the pro- with the opportunity for appeal to the posed brand name is requested. This expla- Department’s Judicial Officer, who nation shall also state what nutritional benefit to the public will derive from use of the shall make the final determination for brand name as proposed. If the branded prod- the Secretary. Any such determination uct is intended for a specific group within by the Secretary shall be conclusive the population, the analysis shall specifi- unless, within 30 days after receipt of cally address nutritional needs of such group notice of such final determination, the and scientific data sufficient for such pur- applicant appeals to the United States pose. Court of Appeals for the circuit in Yours very truly, which the applicant has its principal Applicant lllllllllllllll place of business or to the United States Court of Appeals for the District By lllllllllllllllllll of Columbia Circuit. (2) Upon receipt of the labeling appli- (5) If the claim is approved, the Agen- cation and supporting documentation, cy shall notify the applicant, in writ- the applicant shall be notified, in writing, and shall publish in the FEDERAL ing, of the date on which the labeling REGISTER a notice informing the public application was received. Such notice that the synonymous term has been ap- shall inform the applicant that the la- proved for use. beling application is undergoing Agen- (m)(1) Labeling applications for the cy review and that the applicant shall use of an implied nutrient content subsequently be notified of the Agen- claim in a brand name shall be accom- cy’s decision to consider for further re- panied by the following data which view or deny the labeling application. shall be submitted in the following (3) Upon review of the labeling appli- form to the Director, Food Labeling cation and supporting documentation, Division, Regulatory Programs, Food the Agency shall notify the applicant, Safety and Inspection Service, Wash- in writing, that the labeling applica- ington, DC 20250: tion is either being considered for fur- llllllllllllllllllllllll ther review or that it has been sum- (Date) marily denied by the Administrator. The undersigned, llllll submits this (4) If the labeling application is sum- labeling application pursuant to 9 CFR marily denied by the Administrator, 317.369 with respect to (statement of the im- the written notification shall state the plied nutrient content claim and its proposed reasons therefor, including why the use in a brand name). Agency has determined that the pro- Attached hereto, in quadruplicate, or on a posed implied nutrient content claim is computer disc copy, and constituting a part false or misleading. The notification of this labeling application, are the fol- letter shall inform the applicant that lowing: (i) A statement identifying the implied nu- the applicant may submit a written trient content claim, the nutrient the claim statement by way of answer to the no- is intended to characterize, the cor- tification, and that the applicant shall responding term for characterizing the level have the right to request a hearing of such nutrient as defined by a regulation, with respect to the merits or validity and the brand name of which the implied of the Administrator’s decision to deny claim is intended to be a part. The statement the use of the proposed implied nutri- shall address why the use of the brand-name ent content claim. as proposed will not be misleading. The statement shall provide examples of the (i) If the applicant fails to accept the types of products on which the brand name determination of the Administrator will appear. It shall also include data show- and files an answer and requests a ing that the actual level of the nutrient in hearing, and the Administrator, after the food would qualify the label of the prod- review of the answer, determines the uct to bear the corresponding term defined initial determination to be correct, the by regulation. Assay methods used to determine the level of a nutrient shall meet the Administrator shall file with the Hear- requirements stated under labeling applica- ing Clerk of the Department the notifi- tion format in paragraph (k)(1)(iii) of this cation, answer, and the request for a section. hearing, which shall constitute the

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complaint and answer in the pro- trator and files an answer and requests ceeding, which shall thereafter be con- a hearing, and the Administrator, after ducted in accordance with the Depart- review of the answer, determines the ment’s Uniform Rules of Practice. initial determination to be correct, the (ii) The hearing shall be conducted Administrator shall file with the Hear- before an administrative law judge ing Clerk of the Department the notifi- with the opportunity for appeal to the cation, answer, and the request for a Department’s Judicial Officer, who hearing, which shall thereafter be con- shall make the final determination for ducted in accordance with the Depart- the Secretary. Any such determination ment’s Uniform Rules of Practice. by the Secretary shall be conclusive (B) The hearing shall be conducted unless, within 30 days after receipt of before an administrative law judge notice of such final determination, the with the opportunity for appeal to the applicant appeals to the United States Department’s Judicial Officer, who Court of Appeals for the circuit in shall make the final determination for which the applicant has its principal the Secretary. Any such determination place of business or to the United by the Secretary shall be conclusive States Court of Appeals for the District unless, within 30 days after receipt of of Columbia Circuit. the notice of such final determination, (5) If the labeling application is not the applicant appeals to the United summarily denied by the Adminis- States Court of Appeals for the circuit trator, the Administrator shall publish in which the applicant has its principal a notice of the labeling application in place of business or to the United the FEDERAL REGISTER seeking com- States Court of Appeals for the District ment on the use of the implied nutrient of Columbia Circuit. content claim. The notice shall also (ii) If the claim is approved, the summarize the labeling application, in- Agency shall notify the applicant, in cluding where the supporting docu- writing, and shall also publish in the mentation can be reviewed. The Ad- FEDERAL REGISTER a notice informing ministrator’s notice shall seek com- the public that the implied nutrient ment from consumers, the industry, content claim has been approved for consumer and industry groups, and use. other interested persons on the label- (Paperwork requirements were approved by ing application and the use of the im- the Office of Management and Budget under plied nutrient content claim. After control number 0583–0088) public comment has been received and [58 FR 664, Jan. 6, 1993, as amended at 59 FR reviewed by the Agency, the Adminis- 45196, Sept. 1, 1994; 60 FR 196, Jan. 3, 1995] trator shall make a determination on whether the implied nutrient content §§ 317.370–317.379 [Reserved] claim shall be approved for use on the labeling of meat food products. § 317.380 Label statements relating to (i) If the claim is denied by the Ad- usefulness in reducing or maintain- ministrator, the Agency shall notify ing body weight. the applicant, in writing, of the basis (a) General requirements. Any product for the denial, including the reason that purports to be or is represented why the claim on the labeling was de- for special dietary use because of use- termined by the Agency to be false or fulness in reducing body weight shall misleading. The notification letter bear: shall also inform the applicant that the (1) Nutrition labeling in conformity applicant may submit a written state- with § 317.309 of this subpart, unless ex- ment by way of answer to the notifica- empt under that section, and tion, and that the applicant shall have (2) A conspicuous statement of the the right to request a hearing with re- basis upon which the product claims to spect to the merits or validity of the be of special dietary usefulness. Administrator’s decision to deny the (b) Nonnutritive ingredients. (1) Any use of the proposed implied nutrient product subject to paragraph (a) of this content claim. section that achieves its special die- (A) If the applicant fails to accept tary usefulness by use of a nonnutri- the determination of the Adminis- tive ingredient (i.e., one not utilized in

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normal metabolism) shall bear on its (3) Paragraph (e)(1) of this section label a statement that it contains a shall not apply to any use of such nonnutritive ingredient and the per- terms on a formulated meal replace- centage by weight of the nonnutritive ment or other product that is rep- ingredient. resented to be of special dietary use as (2) A special dietary product may a whole meal, pending the issuance of a contain a nonnutritive sweetener or regulation governing the use of such other ingredient only if the ingredient terms on foods. is safe for use in the product under the (f) ‘‘Sugar free’’ and ‘‘no added sugar’’. applicable law and regulations of this Criteria for the use of the terms ‘‘sugar chapter. Any product that achieves its free’’ and ‘‘no added sugar’’ are pro- special dietary usefulness in reducing vided for in § 317.360(c). or maintaining body weight through [58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, the use of a nonnutritive sweetener 1993, as amended at 58 FR 47627, Sept. 10, shall bear on its label the statement 1993; 58 FR 66075, Dec. 17, 1993; 60 FR 196, Jan. required by paragraph (b)(1) of this sec- 3, 1995] tion, but need not state the percentage by weight of the nonnutritive sweet- §§ 317.381–317.399 [Reserved] ener. If a nutritive sweetener(s) as well § 317.400 Exemption from nutrition la- as nonnutritive sweetener(s) is added, beling. the statement shall indicate the presence of both types of sweetener; e.g., (a) The following meat or meat food ‘‘Sweetened with nutritive sweetener(s) products are exempt from nutrition la- and nonnutritive sweetener(s).’’ beling: (1) Food products produced by small (c) ‘‘Low calorie’’ foods. A product businesses provided that the labels for purporting to be ‘‘low calorie’’ must these products bear no nutrition claims comply with the criteria set forth for or nutrition information, such foods in § 317.360. (i) A food product, for the purposes of (d) ‘‘Reduced calorie’’ foods and other the small business exemption, is de- comparative claims. A product pur- fined as a formulation, not including porting to be ‘‘reduced calorie’’ or oth- distinct flavors which do not signifi- erwise containing fewer calories than a cantly alter the nutritional profile, reference food must comply with the sold in any size package in commerce. criteria set forth for such foods in (ii) For purposes of this paragraph, a § 317.360(b) (4) and (5). small business is any single-plant facil- (e) ‘‘Label terms suggesting usefulness ity or multi-plant company/firm that as low calorie or reduced calorie foods’’. employs 500 or fewer people and pro- (1) Except as provided in paragraphs duces no more than the following (e)(2) and (e)(3) of this section, a prod- amounts of pounds of the product uct may be labeled with terms such as qualifying the firm for exemption from ‘‘diet,’’ ‘‘dietetic,’’ ‘‘artificially sweet- this subpart: ened,’’ or ‘‘sweetened with nonnutri- (A) During the first year of imple- tive sweetener’’ only if the claim is not mentation of nutrition labeling, from false or misleading, and the product is July 1994 to July 1995, 250,000 pounds or labeled ‘‘low calorie’’ or ‘‘reduced cal- less, orie’’ or bears another comparative cal- (B) During the second year of imple- orie claim in compliance with the ap- mentation of nutrition labeling, from plicable provisions in this subpart. July 1995 to July 1996, 175,000 pounds or (2) Paragraph (e)(1) of this section less, and shall not apply to any use of such (C) During the third year of imple- terms that is specifically authorized by mentation and subsequent years there- regulation governing a particular food, after, 100,000 pounds or less. or, unless otherwise restricted by regu- (iii) For purposes of this paragraph, lation, to any use of the term ‘‘diet’’ calculation of the amount of pounds that clearly shows that the product is shall be based on the most recent 2- offered solely for a dietary use other year average of business activity. than regulating body weight, e.g., ‘‘for Where firms have been in business less low sodium diets.’’ than 2 years or where products have

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been produced for less than 2 years, be placed immediately below the quan- reasonable estimates must indicate titative information by weight for pro- that the annual pounds produced will tein; not exceed the amounts specified. (iv) The percent of the Daily Value (2) Products intended for further for protein, vitamins, and minerals processing, provided that the labels for shall be listed immediately below the these products bear no nutrition claim heading ‘‘Percent Daily Value’’; and or nutrition information, (v) Such labeling shall not include (3) Products that are not for sale to the footnote specified in § 317.309(d)(9). consumers, provided that the labels for (d)(1) Products in packages that have these products bear no nutrition claims a total surface area available to bear or nutrition information, labeling of less than 12 square inches (4) Products in small packages that are exempt from nutrition labeling, are individually wrapped packages of provided that the labeling for these 1 less than ⁄2 ounce net weight, provided products bear no nutrition claims or that the labels for these products bear other nutrition information. The man- no nutrition claims or nutrition infor- ufacturer, packer, or distributor shall mation, provide, on the label of packages that (5) Products custom slaughtered or qualify for and use this exemption, an prepared, address or telephone number that a (6) Products intended for export, and consumer can use to obtain the re- (7) The following products prepared quired nutrition information (e.g., and served or sold at retail provided ‘‘For nutrition information call 1–800– that the labels or the labeling of these 123–4567’’). products bear no nutrition claims or nutrition information: (2) When such products bear nutri- (i) Ready-to-eat products that are tion labeling, either voluntarily or be- packaged or portioned at a retail store cause nutrition claims or other nutri- or similar retail-type establishment; tion information is provided, all re- and quired information shall be in a type (ii) Multi-ingredient products (e.g., size no smaller than 6 point or all 1 sausage) processed at a retail store or upper case type of ⁄16-inch minimum similar retail-type establishment. height, except that individual serving- (b) Restaurant menus generally do size packages of meat products that not constitute labeling or fall within have a total area available to bear la- the scope of these regulations. beling of 3 square inches or less may (c)(1) Foods represented to be specifi- provide all required information in a cally for infants and children less than type size no smaller than 1⁄32-inch min- 2 years of age shall bear nutrition la- imum height. beling as provided in paragraph (c)(2) of [58 FR 664, Jan. 6, 1993, as amended at 58 FR this section, except such labeling shall 47627, Sept. 10, 1993; 59 FR 45196, Sept. 1, 1994; not include calories from fat, calories 60 FR 196, Jan. 3, 1995] from saturated fat, saturated fat, ste- EFFECTIVE DATE NOTE: At 75 FR 82165, Dec. aric acid, polyunsaturated fat, 29, 2010, § 317.400 was amended as follows, ef- monounsaturated fat, and cholesterol. fective Jan. 1, 2012. At 76 FR 76890, Dec. 9, (2) Foods represented or purported to 2011, the effectiveness was delayed until Mar. be specifically for infants and children 1, 2012. less than 4 years of age shall bear nu- a. Revising paragraph (a)(1) introductory trition labeling except that: text; (i) Such labeling shall not include b. Amending paragraph (a)(1)(ii) by adding declarations of percent of Daily Value ‘‘, including a single retail store,’’ after the for total fat, saturated fat, cholesterol, phrase ‘‘single-plant facility,’’ and by add- sodium, potassium, total carbohydrate, ing, ‘‘, including a multi-retail store oper- and dietary fiber; ation,’’ after ‘‘company/firm’’; c. Amending paragraph (a)(7)(i) by remov- (ii) Nutrient names and quantitative ing the semi-colon and ‘‘and’’ and by adding amounts by weight shall be presented the following at the end of the paragraph: ‘‘, in two separate columns; provided, however, that this exemption does (iii) The heading ‘‘Percent Daily not apply to ready-to-eat ground or chopped Value’’ required in § 317.309(d)(6) shall meat products described in § 317.301 that are

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packaged or portioned at a retail establish- 318.4 Preparation of products to be offi- ment, unless the establishment qualifies for cially supervised; responsibilities of offi- an exemption under (a)(1);’’; cial establishments; plant operated qual- d. Amending paragraph (a)(7)(ii) by remov- ity control. ing the period and by adding the following at 318.5 Requirements concerning procedures. the end of the paragraph: ‘‘, provided, how- 318.6 Requirements concerning ingredients ever, that this exemption does not apply to and other articles used in preparation of multi-ingredient ground or chopped meat products. products described in § 317.301 that are proc- 318.8 Preservatives and other substances essed at a retail establishment, unless the permitted in product for export only; establishment qualifies for an exemption handling; such product not to be used for under (a)(1); and’’; domestic food purposes. e. Adding a new paragraph (a)(7)(iii); and 318.9 Samples of products, water, dyes, f. Paragraph (d)(1) is amended by removing chemicals, etc., to be taken for examina- the period at the end of the first sentence, tion. and by adding the following to the end of the 318.10 Prescribed treatment of pork and first sentence: ‘‘, except that this exemption products containing pork to destroy does not apply to the major cuts of single-in- trichinae. gredient, raw meat products identified in 318.11 [Reserved] § 317.344.’’ 318.12 Manufacture of dog food or similar For the convenience of the user, the added uninspected article at official establish- and revised text is set forth as follows: ments. 318.13 Mixtures containing product but not § 317.400 Exemption from nutrition labeling. amendable to the Act. (a) * * * 318.14 Adulteration of product by polluted water; procedure for handling. (1) Food products produced by small busi- 318.15 Tagging chemicals, preservatives, ce- nesses, other than the major cuts of single- reals, spices, etc., ‘‘U.S. retained.’’ ingredient, raw meat products identified in 318.16 Pesticide chemicals and other resi- § 317.344 produced by small businesses, pro- dues in products. vided that the labels for these products bear 318.17 Requirements for the production of no nutrition claims or nutrition informa- cooked beef, roast beef, and cooked tion, and ground or chopped products de- corned beef products. scribed in § 317.301 produced by small busi- 318.18 Handling of certain material for me- nesses that bear a statement of the lean per- chanical processing. centage and fat percentage on the label or in 318.19 Compliance procedure for cured pork labeling in accordance with § 317.362(f), pro- products. vided that labels or labeling for these prod- 318.20 Use of animal drugs. ucts bear no other nutrition claims or nutri- 318.21 [Reserved] tion information, 318.22 Determination of added water in cooked sausages. * * * * * 318.23 Heat-processing and stabilization requirements for uncured meat patties. (7) * * * 318.24 Product prepared using advanced (iii) Products that are ground or chopped meat/bone separation machinery; process at an individual customer’s request. control.

* * * * * Subparts B–F [Reserved] Subpart G—Canning and Canned PART 318—ENTRY INTO OFFICIAL Products ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PROD- 318.300 Definitions. 318.301 Containers and closures. UCTS 318.302 Thermal processing. 318.303 Critical factors and the application Subpart A—General of the process schedule. 318.304 Operations in the thermal processing Sec. area. 318.1 Products and other articles entering 318.305 Equipment and procedures for heat official establishments. processing systems. 318.2 Reinspection, retention, and disposal 318.306 Processing and production records. of meat and poultry products at official 318.307 Record review and maintenance. establishments. 318.308 Deviations in processing. 318.3 Designation of places of receipt of 318.309 Finished product inspection. products and other articles for reinspec- 318.310 Personnel and training. tion. 318.311 Recall procedure.

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AUTHORITY: 7 U.S.C. 138f, 450, 1901–1906; 21 tablishment and at all times while it is U.S.C. 601–695; 7 CFR 2.18, 2.53. in such establishment, shall bear a label showing the name of the article, Subpart A—General the amount or percentage therein of any substances restricted by this part SOURCE: 35 FR 15586, Oct. 3, 1970, unless or part 317 of this subchapter, and a list otherwise noted. of ingredients in the article if composed of two or more ingredients: Pro- § 318.1 Products and other articles en- vided, That in the case of articles re- tering official establishments. ceived in tank car lots, only one such (a) Except as otherwise provided in label shall be used to identify each lot. paragraphs (g) and (h) of this section or In addition, the label must show the § 318.12, no product shall be brought name and address of the shipper. into an official establishment unless it (d) To ensure the safe use of prepara- has been prepared only in an official es- tions used in hog scalding water or in tablishment and previously inspected the denuding of tripe, the label or la- and passed by a Program employee, beling on containers of such prepara- and is identified by an official inspections shall bear adequate directions to tion legend as so inspected and passed. ensure use in compliance with any lim- Notwithstanding the foregoing provi- itations prescribed in 21 CFR Chapter I, sions of this subparagraph, product im- Subchapter A or Subchapter B, or 9 ported in accordance with part 327 of CFR Chapter III, Subchapter A or Sub- this subchapter and not prepared in the chapter E. United States outside an official estab- (e) Dyes, chemicals, or other sub- lishment, may enter any official estab- stances the use of which is restricted lishment subject in other respects to to certain products may be brought the same restrictions as apply to do- into or kept in an official establish- mestic product. Products received in ment only if such products are pre- an official establishment during the pared thereat. No prohibited dye, Program employees absence shall be chemical, preservative, or other sub- identified and maintained in a manner stance shall be brought into or kept in acceptable to such employee. Product an official establishment. entering any official establishment (f) [Reserved] shall not be used or prepared thereat (g) Glands and organs, such as until it has been reinspected in accord- cotyledons, ovaries, prostate glands, ance with § 318.2. Any product origi- tonsils, spinal cords, and detached lym- nally prepared at any official establish- phatic, pineal, pituitary, parathyroid, ment may not be returned into any suprarenal, pancreatic and thyroid part of such establishment, except the glands, used in preparing pharma- receiving area approved under § 318.3, ceutical, organotherapeutic, or tech- until it has been reinspected by the in- nical products and which are not used spector. as human food (whether or not pre- (b) No slaughtered poultry or poultry pared at official establishments) may product shall be brought into an offi- be brought into and stored in edible cial establishment unless it has been product departments of inspected es- (1) previously inspected and passed and tablishments if packaged in suitable is identified as such in accordance with containers so that the presence of such the requirements of the Poultry Prod- glands and organ will in no way inter- ucts Inspection Act (21 U.S.C. 451 et fere with the maintenance of sanitary seq.) and the regulations thereunder, conditions or constitute an inter- and has not been prepared other than ference with inspection. Glands or or- in an establishment inspected under gans which are regarded as human food said Act, or (2) has been inspected and products, such as livers, testicles, and passed and is identified as such in ac- thymus glands, may be brought into of- cordance with the requirements of a ficial establishments for pharma- State law. ceutical, organotherapeutic or tech- (c) Every article for use as an ingre- nical purposes, only if U.S. inspected dient in the preparation of meat food and passed and so identified. Lungs and products, when entering any official es- lung lobes derived from livestock

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slaughtered in any establishment may spection Act or the Federal Food, not be brought into any official estab- Drug, and Cosmetic Act, or applicable lishment except as provided in State laws, the appropriate govern- § 318.12(a). mental authorities will be notified. (h)(1) Carcasses of game animals, and [35 FR 15586, Oct. 3, 1970, as amended at 36 FR carcasses derived from the slaughter by 11639, June 17, 1971; 38 FR 5152, Feb. 26, 1973; any person of livestock of his own rais- 48 FR 6091, Feb. 10, 1983; 49 FR 32055, Aug. 10, ing in accordance with the exemption 1984; 64 FR 72174, Dec. 23, 1999] provisions of paragraph 23(a) of the Act, and parts of such carcasses, may § 318.2 Reinspection, retention, and be brought into an official establish- disposal of meat and poultry prod- ment for preparation, packaging, and ucts at official establishments. storing in accordance with the provi- (a) All products and all slaughtered sions of § 303.1(a)(2) of this subchapter. poultry and poultry products brought (2) Meat, meat byproducts, and meat into any official establishment shall be food products bearing official marks identified by the operator of the offi- showing that they were inspected and cial establishment at the time of re- passed under State inspection in any ceipt at the official establishment and State not designated in § 331.2 of this shall be subject to reinspection by a subchapter may be received by official Program employee at the official es- establishments for storage and dis- tablishment in such manner and at tribution solely in intrastate com- such times as may be deemed necessary merce. The presence of such State in- to assure compliance with the regula- spected products must not create any tions in this subchapter. unsanitary condition or otherwise re- (b) All products, whether fresh, sult in adulteration of any products at cured, or otherwise prepared, even the official establishment or interfere though previously inspected and with the conduct of inspection under passed, shall be reinspected by Pro- this subchapter. In addition, such gram employees as often as they may State inspected products must be deem necessary in order to ascertain stored separately and apart from the that they are not adulterated or mis- federally inspected products in the offi- branded at the time they enter or leave cial establishment. official establishments and that the re- (i) The operator of the official estab- quirements of the regulations in this lishment shall furnish such informa- subchapter are complied with. tion as is necessary to determine the (c) Reinspection may be accomplished through use of statistically origin of any product or other article sound sampling plans that assure a entering the official establishment. high level of confidence. The circuit su- Such information shall include, but is pervisor shall designate the type of not limited to, the name and address of plan and the program employee shall the seller or supplier, transportation select the specific plan to be used in company, agent, or broker involved in accordance with instructions issued by the sale or delivery of the product or the Administrator. 1 article in question. (d) A U.S. retained tag shall be (j) Any product or any poultry or placed by a Program employee at the poultry product or other article that is brought into an official establishment 1 contrary to any provision of this sec- Further information concerning sampling plans which have been adopted for specific tion may be required by the Adminis- products may be obtained from the Circuit trator to be removed immediately from Supervisors of Program circuits. These sam- such establishment by the operator pling plans are developed for individual prod- thereof, and failure to comply with ucts by the Washington staff and will be dis- such requirement shall be deemed a tributed for field use as they are developed. violation of this regulation. If any The type of plan applicable depends on fac- slaughtered poultry or poultry prod- tors such as whether the product is in containers, stage of preparation, and procedures ucts or other articles are received at an followed by the establishment operator. The official establishment and are sus- specific plan applicable depends on the kind pected of being adulterated or mis- of product involved, such as liver, oxtails, branded under the Poultry Products In- etc.

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time of reinspection at any official es- which products and other articles sub- tablishment on all products which are ject to reinspection under § 318.2 shall suspected on such reinspection of being be received, and such products and ar- adulterated or misbranded, and such ticles shall be received only at such products shall be held for further in- dock or place. spection. Such tags shall be removed only by authorized Program employ- § 318.4 Preparation of products to be ees. When further inspection is made, if officially supervised; responsibil- the product is found to be adulterated, ities of official establishments; all official inspection legends or other plant operated quality control. official marks for which the product is (a) All processes used in curing, pick- found to be ineligible under the regula- ling, rendering, canning, or otherwise tions in this subchapter, shall be re- preparing any product in official estab- moved or defaced and the product will lishments shall be supervised by Pro- be subject to condemnation and dis- gram employees unless such prepara- posal in accordance with part 314 of tion is conducted as a custom oper- this subchapter, except that a deter- ation exempted from inspection under mination regarding adulteration may § 303.1(a)(2) of this subchapter in any of- be deferred if a product has become ficial establishment or consists of oper- soiled or unclean by falling on the floor ations that are exempted from inspec- or in any other accidental way or if the tion under § 303.1(d) of this subchapter product is affected with any other con- and are conducted in a retail store in dition which the inspector deems capa- an establishment subject to inspection ble of correction, in which case the product shall be cleaned (including only because the State or Territory in trimming if necessary) or otherwise which the establishment is located is handled in a manner approved by the designated under paragraph 301(c) of inspector to assure that it will not be the Act. No fixtures or appliances, such adulterated or misbranded and shall as tables, trucks, trays, tanks, vats, then be presented for reinspection and machines, implements, cans, or con- disposal in accordance with this sec- tainers of any kind, shall be used un- tion. If upon final inspection, the prod- less they are of such materials and con- uct is found to be neither adulterated struction as will not contaminate or nor misbranded, the inspector shall re- otherwise adulterate the product and move the U.S. retained tag. If a prod- are clean and sanitary. All steps in the uct is found upon reinspection to be preparation of edible products shall be misbranded, it shall be held under a conducted carefully and with strict U.S. retained tag, or a U.S. detention cleanliness in rooms or compartments tag as provided in part 329 of this sub- separate from those used for inedible chapter, pending correction of the mis- products. branding or issuance of an order under (b) It shall be the responsibility of section 7 of the Act to withhold from the operator of every official establish- use the labeling or container of the ment to comply with the Act and the product, or the institution of a judicial regulations in this subchapter. In order seizure action under section 403 of Act to carry out this responsibility effec- or other appropriate action. The in- tively, the operator of the establish- spector shall make a complete record ment shall institute appropriate meas- of each transaction under this para- ures to assure the maintenance of the graph and shall report his action to the establishment and the preparation, area supervisor. marking, labeling, packaging and other handling of its products strictly in ac- [35 FR 15586, Oct. 3, 1970; 36 FR 11903, June 23, 1971] cordance with the sanitary and other requirements of this subchapter. The § 318.3 Designation of places of receipt effectiveness of such measures will be of products and other articles for subject to review by the Department. reinspection. (c) Applying for Total Plant Quality Every official establishment shall Control. Any owner or operator of an designate, with the approval of the cir- official establishment preparing meat cuit supervisor, a dock or place at food product who has a total plant

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quality control system or plan for con- (4) Detailed information concerning trolling such product, after ante- the manner in which the system will mortem and post-mortem inspection, function. Such information should in- through all stages of preparation, may clude, but not necessarily be limited request the Administrator to evaluate to, questions of raw material control, it to determine whether or not that the critical check or control points, system is adequate to result in product the nature and frequency of tests to be being in compliance with the require- made, the nature of charts and other ments of the Act and therefore qualify records that will be used, the length of as a U.S. Department of Agriculture time such charts and records will be (USDA) Total Plant Quality Control maintained in the custody of the offi- Establishment. Such a request shall, as cial establishment, the nature of defi- a minimum, include: ciencies the quality control system is (1) A letter to the Administrator designed to identify and control, the from the establishment owner of oper- parameters or limits which will be ator stating the company’s basis and used, and the points at which correc- purpose for seeking an approved qual- tive action will occur and the nature of ity control system and willingness to such corrective action—ranging from adhere to the requirements of the sys- least to most severe: Provided, That, tem as approved by the Department; subsequent to approval of the total that all the establishment’s data, anal- plant quality control system by the yses, and information generated by its Administrator, the official establish- quality control system will be main- ment may produce a new product for tained to enable the Department to test marketing provided labeling for monitor compliance and available to the product has been approved by the Department personnel; that plant qual- Administrator, the inspector in charge ity control personnel will have author- has determined that the procedures for ity to halt production or shipping of preparing the product will assure that product in cases where the submitted all Federal requirements are met, and quality control system requires it; and the production for test marketing does that the owner or operator (or his/her not exceed 6 months. Such new product designee) will be available for consulta- shall not be produced at that establish- tion at any time Department personnel ment after the 6-month period unless consider it necessary. approval of the quality control system (2) In the case of an establishment for that product has been received from having one or more full-time persons the Administrator. whose primary duties are related to the quality control system, an organiza- (d) [Reserved] tional chart showing that such people (e) Evaluation and Approval of Total ultimately report to an establishment Plant Quality Control. (1) The Adminis- official whose quality control respon- trator shall evaluate the material pre- sibilities are independent of or not presented in accordance with the provi- dominantly production responsibil- sions of paragraph (c) of this section. If ities. In the case of an establishment it is determined by the Administrator, which does not have full-time quality on the basis of the evaluation, that the control personnel, information indi- total quality control system will result cating the nature of the duties and rein finished products controlled in this sponsibilities of the person who will be manner being in full compliance with responsible for the quality control sys- the requirements of the Act and regu- tem. lations thereunder, the total quality (3) A list identifying those parts and control system will be approved and sections of the Federal meat inspection plans will be made for implementation regulations which are applicable to the under departmental supervision. operations of the establishment apply- (2) In any situation where the system ing for approval of a quality control is found by the Administrator to be un- system. This list shall also identify acceptable, formal notification shall be which part of the quality control sys- given to the applicant of the basis for tem will serve to maintain compliance the denial. The applicant will be af- with the applicable regulations. forded an opportunity to modify the

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system in accordance with the notifica- (g) Termination of Total Plant Quality tion. The applicant shall also be af- Control. (1) The approval of a total forded an opportunity to submit a writ- plant quality control system may be ten statement in response to this noti- terminated at any time by the owner fication of denial and a right to request or operator of the official establish- a hearing with respect to the merits or ment upon written notice to the Ad- validity of the denial. If the applicant ministrator. requests a hearing and the Adminis- (2) The approval of a total plant qual- trator, after review of the answer, de- ity control system may be terminated termines the initial determination to upon the establishment’s receipt of a be correct, he shall file with the Hear- written notice from the Administrator ing Clerk of the Department the notifi- under the following conditions: cation, answer and the request for (i) If adulterated or misbranded meat hearing, which shall constitute the food product is found by the Adminis- complaint and answer in the proceeding, which shall thereafter be con- trator to have been prepared for or dis- ducted in accordance with Rules of tributed in commerce by the subject Practice which shall be adopted for establishment. In such case, oppor- this proceeding. tunity will be provided to the estab- (3) The establishment owner or oper- lishment owner or operator to present ator shall be responsible for the effec- views to the Administrator within 30 tive operation of the approved total days of the date of terminating the ap- plant quality control system to assure proval. In those instances where there compliance with the requirements of is conflict of facts, a hearing, under ap- the Act and regulations thereunder. plicable Rules of Practice, will be pro- The Secretary shall continue to provided to the establishment owner or vide the Federal inspection necessary operator to resolve the conflict. The to carry out his responsibilities under Administrator’s termination of ap- the Act. proval shall remain in effect pending (f) Labeling Logo. Owners and opera- the final determination of the pro- tors of official establishments having a ceeding. total plant quality control system ap- (ii) If the establishment fails to com- proved under the provisions of para- ply with the quality control system or graph (c) of this section, may only use, program to which it has agreed after as a part of any labeling, the following being notified by letter from the Ad- logo. Any labeling bearing the logo and ministrator or his designee. Prior to any wording of explanation with re- such termination, opportunity will be spect to this logo shall be approved as provided to the establishment owner or required by parts 316 and 317 of this operator to present views to the Ad- subchapter. ministrator within 30 days of the date of the letter. In those instances where there is a conflict of facts, a hearing, under applicable Rules of Practice, will be provided to the establishment owner or operator to resolve the conflict. The Administrator’s termination of quality control approval shall remain in effect pending the final determination of the proceeding. (3) If approval of the total establishment quality control system has been terminated in accordance with the provisions of this section, an application and request for approval of the same or a modified total establishment quality control system will not be evaluated by the Administrator for at least 6 months from the termination date.

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(h)(1) Operating Schedule Under Total (2) Frozen product may be defrosted Plant Quality Control. An official estab- in water or pickle in a manner and lishment with an approved total plant with the use of facilities which are ac- quality control system may request ap- ceptable to the inspector. Before such proval for an operating schedule of up product is defrosted, a careful exam- to 12 consecutive hours per shift. Per- ination shall be made to determine its mission will be granted provided that: condition. If necessary, this examina- (i) The official establishment has sat- tion shall include defrosting of rep- isfactorily operated under a total plant resentative samples by means other quality control system for at least 1 than in water or pickle. year. (b) Product, such as pork tenderloins, (ii) All products prepared and pack- brains, sweetbreads, stew, or chop aged, or processed after the end of 8 suey, shall not be packed in hermeti- hours of inspection shall only be a con- cally sealed metal or glass containers, tinuation of the processing monitored unless subsequently heat processed or by the inspector and being conducted otherwise treated to preserve the prod- during the last hour of inspection. uct in a manner approved by the Ad- (iii) All immediate containers of ministrator in specific cases. products prepared and packaged shall (c) Care shall be taken to remove bear code marks that are unique to any bones and parts of bones from product period of production beyond the 8 hours which is intended for chopping. of inspection. The form of such code (d) Heads for use in the preparation marks will remain constant from day of meat food products shall be split and to day, and a facsimile of the code the bodies of the teeth, the turbinated marks and their meaning shall be pro- and ethmoid bones, ear tubes, and horn vided to the inspector. butts removed, and the heads then (2) Application. Applications shall be thoroughly cleaned. submitted to the Regional Director and (e) Kidneys for use in the preparation shall specify how the conditions in of meat food products shall first be § 318.4(h)(1) have been or will be met. freely sectioned and then thoroughly (3) Monitoring by Inspectors. In order soaked and washed. All detached kid- to verify that an establishment is pre- neys, including beef kidneys with de- paring and shipping product in accord- tached kidney fat, shall be inspected ance with the approved total plant before being used in or shipped from quality control system and the Act and the official establishment. regulations after the 8 hours of inspec- (f) Cattle paunches and hog stomachs tion, the official establishment may be for use in the preparation of meat food provided overtime inspection services products shall be thoroughly cleaned at the discretion of the circuit super- on all surfaces and parts immediately visor and charged for such services. after being emptied of their contents, (Reporting requirements were approved by which shall follow promptly their re- the Office of Management and Budget under moval from the carcasses. control number 0583–0015) (g) Clotted blood shall be removed from hog hearts before they are [35 FR 15586, Oct. 3, 1970, as amended at 36 FR 12003, June 24, 1971; 45 FR 54322, Aug. 15, 1980; shipped from the official establishment 51 FR 32304, Sept. 11, 1986; 62 FR 45024, Aug. or used in the preparation of meat food 25, 1997; 62 FR 54759, Oct. 22, 1997; 65 FR 34389, products. May 30, 2000] (h) Beef rounds, beef bungs, beef middles, beef bladders, calf rounds, hog § 318.5 Requirements concerning pro- bungs, hog middles, and hog stomachs cedures. which are to be used as containers of (a)(1) Care shall be taken to assure any meat food product shall be pre- that product is not adulterated when sented for inspection, turned with the placed in freezers. If there is doubt as fat surface exposed. to the soundness of any frozen product, (i) Portions of casings which show in- the inspector will require the fection with Oesophagostomum or defrosting and reinspection of a suffi- other nodule-producing parasite, and cient quantity thereof to determine its weasands infected with the larvae of actual condition. Hypoderma lineatum, shall be rejected,

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except that when the infestation is in these substances to act on the cas- slight and the nodules and larvae are ings to make them less resistant. The removed, the casing or weasand may be casings shall be handled in a clean and passed. sanitary manner throughout and the [35 FR 15586, Oct. 3, 1970; 36 FR 11903, June 23, treatment shall be followed by washing 1971] and flushing the casings with water sufficiently to effectively remove the § 318.6 Requirements concerning in- substance used and terminate the enzy- gredients and other articles used in matic action. preparation of products. (4) On account of the invariable pres- (a) All ingredients and other articles ence of bone splinters, detached spinal used in the preparation of any product cords shall not be used in the prepara- shall be clean, sound, healthful, whole- tion of edible product other than for some, and otherwise such as will not rendering where they constitute a suit- result in the product being adulterated. able raw material. Detached spinal Official establishments shall furnish cords from cattle 30 months of age and inspectors accurate information on all older shall not be used as raw mate- procedures involved in product prepa- rials for edible rendering. ration including product composition (5) Testicles if handled as an edible and any changes in such procedures es- product may be shipped from the offi- sential for inspectional control of the cial establishment as such, but they product. shall not be used as an ingredient of a (b)(1) The only animal casings that meat food product. may be used as containers of product (6) Tonsils shall be removed and shall are those from sheep, swine, or goats. not be used as ingredients of meat food Casings from cattle may be used as products. containers of products. However, if cas- (7) Blood from livestock prepared in ings from cattle are derived from the accordance with § 310.20 of this sub- small intestine, the small intestine chapter may be used as an ingredient must comply with the requirements in of a meat food product for which a 9 CFR 310.22(d). Establishments that standard is prescribed in part 319 of use casings derived from the small in- this subchapter, if permitted by such testine of cattle as containers for prod- standard, and may be used in any meat ucts must demonstrate, through docu- food product for which no such stand- mentation, that the small intestine ard is prescribed in part 319 of this sub- from which the casing was derived chapter if it is a common and usual in- complies with the requirements in 9 gredient of such product. CFR 310.22(d). (8) Intestines shall not be used as in- (2) Casings for products shall be care- gredients in any meat food product for fully inspected by Program employees. which a standard is prescribed in part Only those casings which have been 319 of this subchapter and shall not be carefully washed and thoroughly used in other products unless the prod- flushed with clean water immediately ucts are labeled in accordance with before stuffing and are suitable for con- § 317.8(b)(3) of this subchapter. When tainers, are clean, and are passed on small intestine from cattle is used in a such inspection shall be used, except meat food product or for edible ren- that preflushed animal casings packed dering, it must comply with the rein salt or salt and glycerine solution or quirements in 9 CFR 310.22(d). other approved medium may be used (9) Poultry products and egg products without additional flushing provided (other than shell eggs) which are in- they are found to be clean and other- tended for use as ingredients of meat wise acceptable and are thoroughly food products shall be considered ac- rinsed before use. ceptable for such use only when identi- (3) Hog and sheep casings intended fied as having been inspected and for use as containers of product may be passed for wholesomeness by the De- treated by soaking in or applying partment under the regulations in 7 thereto sound, fresh pineapple juice or CFR part 59 or 9 CFR part 362 or 381 papain or bromelin or pancreatic ex- and when found to be sound and other- tract to permit the enzymes contained wise acceptable when presented for use.

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Poultry products and egg products tor in charge so that the identity of (other than shell eggs) which have not the export product is maintained con- been so inspected and passed for whole- clusively and the preparation of domes- someness shall not be used in the prep- tic product is adequately protected. aration of such meat food products. The preservatives and other substances (10) Dry milk products which are in- not permitted in domestic product tended for use as ingredients of meat shall be stored in a room or compart- food products shall be considered ac- ment separate from areas used to store ceptable for such use only when pro- other supplies and shall be held under duced in a plant approved by the De- Program lock. Use of the preservatives partment under the regulations in 7 or other substances shall be under the CFR part 58, and when found to be direct supervision of a Program em- sound and otherwise acceptable when ployee. presented for use. Dry milk products (c) The packing of all articles under prepared in a plant not so approved paragraph (a) of this section shall be shall not be used in the preparation of conducted under the direct supervision such meat food products. of a Program employee. (11) [Reserved] (12) Ingredients for use in any prod- (d) No article prepared or packed for uct may not bear or contain any pes- export under paragraph (a) of this sec- ticide chemical or other residues in ex- tion shall be sold or offered for sale for cess of level permitted in § 318.16. domestic use or consumption, but un- (13) Use of ‘‘Mechanically Separated less exported shall be destroyed for (Kind of Poultry),’’ as defined in food purposes under the direct super- § 381.173 of this chapter, in the prepara- vision of a Program employee. tion of meat food products shall accord (e) The contents of the container of with § 381.174 and all other applicable any article prepared or packed for ex- provisions of this subchapter. port under paragraph (a) of this section shall not be removed, in whole or in [35 FR 15586, Oct. 3, 1970, as amended at 38 FR part, from such container prior to ex- 14368, June 1, 1973; 38 FR 29214, Oct. 23, 1973; 39 FR 1973, Jan. 16, 1974; 41 FR 23702, June 11, portation, except under the supervision 1976; 49 FR 19623, May 9, 1984; 50 FR 6, Jan. 2, of a Program employee. If such con- 1985; 60 FR 55982, Nov. 3, 1995; 69 FR 1874, Jan. tents are removed prior to exportation, 12, 2004; 70 FR 53050, Sept. 7, 2005; 72 FR 38730, then the article shall be either re- July 13, 2007] packed, in accordance with the provisions of paragraphs (b) and (c) of this § 318.8 Preservatives and other subsection, or destroyed for food purposes stances permitted in product for export only; handling; such product under the direct supervision of a Pro- not to be used for domestic food gram employee. purposes. (f) Permission must be obtained from (a) Preservatives and other sub- the Administrator before meats packed stances not permitted in domestic in borax are shipped from one official product under the regulations in this establishment to another or to an unof- subchapter may be used in the prepara- ficial establishment for storage, except tion and packing of product intended such meat prepared for the account of for export provided the product (1) ac- Federal agencies. cords to the specifications or direc- (g) At all times, the identity of meat tions of the foreign purchaser; (2) is not to which borax has been added shall be in conflict with the laws of the country effectively maintained. In no case shall to which it is intended for export; and such meat, nor any trimmings or fat (3) is labeled on the outside container derived from such meat, whether un- to show that it is intended for export, washed or washed, or otherwise treat- and is otherwise labeled as required by ed, be diverted to domestic use. this subchapter for such export prod- (h) Salt used for bulking meat pre- uct. viously packed in borax may not again (b) The preparation and packing of be used in an edible products depart- export product as provided for in para- ment other than in connection with graph (a) of this section shall be done the packing of meat in borax. Only in a manner acceptable to the inspec- metal equipment should be used for

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handling such meat. Particularly effec- (2) Pork from carcasses or carcass tive cleansing will be required if wood- parts that have been found free of en equipment such as trucks, washing trichinae as described under paragraph vats, etc., is used. Boxes from which (e) or (f) of this section is not required boraxed meat has been removed may be to be treated for the destruction of used for repacking meat in borax, but trichinae. their use as containers for other meat (b) Products named in this para- will be dependent upon the effective re- graph, and products of the character moval of all traces of borax. hereof, containing pork muscle tissue (i) The following instructions pertain (not including pork hearts, pork stom- to export cured pork packed in borax achs, and pork livers), or the pork mus- for the account of Federal agencies. cle tissue which forms an ingredient of The meat may be packed in borax in a such products, shall be effectively room in which there is borax-free meat, provided proper care is taken to see heated, refrigerated, or cured to de- that the borax-free meat is not affected stroy any possible live trichinae, as by the borax. Under the same condi- prescribed in this section at the official tion, meat packed in borax may be re- establishment where such products are ceived, unpacked, defrosted, soaked, prepared: Bologna, frankfurter, vienna, washed, smoked, and repacked in a and other cooked sausage; smoked sau- room where there is other meat. How- sage; knoblauch sausage; mortadella; ever, meat originally packed in borax all forms of summer or dried sausage, shall at all times be subject to the re- including mettwurst; flavored pork strictions of meat so packed, even sausages such as those containing wine though repacked without borax. After or similar flavoring materials; cured packing or repacking, borax packed pork sausage; sausage containing cured meat may be stored in a room with and/or smoked pork; cooked loaves; meat not packed in borax, provided a roasted, baked, boiled, or cooked hams, reasonable degree of separation is pork shoulders, or pork shoulder pic- maintained between the two classes of nics; Italian-style hams; Westphalia- product. style hams; smoked boneless pork [35 FR 15586, Oct. 3, 1970; 36 FR 11903, June 23, shoulder butts; cured meat rolls; 1971, as amended at 38 FR 29214, Oct. 23, 1973] capocollo (capicola, capacola); coppa; fresh or cured boneless pork shoulder § 318.9 Samples of products, water, butts, hams, loins, shoulders, shoulder dyes, chemicals, etc., to be taken for picnics, and similar pork cuts, in cas- examination. ings or other containers in which Samples of products, water, dyes, ready-to-eat delicatessen articles are chemicals, preservatives, spices, or customarily enclosed (excepting other articles in any official establish- Scotch-style hams); breaded pork prod- ment shall be taken, without cost to ucts; cured boneless pork loins; the Program, for examination, as often boneless back bacon; bacon used for as may be deemed necessary for the ef- wrapping around patties, steaks and ficient conduct of the inspection. similar products; and smoked pork cuts § 318.10 Prescribed treatment of pork such as hams, shoulders, loins, and and products containing pork to de- pork shoulder picnics (excepting stroy trichinae. smoked hams, and smoked pork shoul- (a)(1) All forms of fresh pork, includ- der picnics which are specially pre- ing fresh unsmoked sausage containing pared for distribution in tropical cli- pork muscle tissue, and pork such as mates or smoked hams delivered to the bacon and jowls, other than those cov- Armed Services); ground meat mix- ered by paragraph (b) of this section, tures containing pork and beef, veal, are classed as products that are cus- lamb, mutton, or goat meat and other tomarily well cooked in the home or product consisting of mixtures of pork elsewhere before being served to the and other ingredients, which the Ad- consumer. Therefore, the treatment of ministrator determines at the time the such products for the destruction of labeling for the product is submitted trichinae is not required. for approval in accordance with part

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317 of the regulations in this sub- innermost links of bunched sausage or chapter or upon subsequent reevalua- other massed articles, and pieces tion of the product, would be prepared placed in the coolest part of a heating in such a manner that the product cabinet or compartment or vat be in- might be eaten rare or without thor- cluded in the temperature tests. ough cooking because of the appear- (2) Refrigerating. At any stage of prep- ance of the finished product or other- aration and after preparatory chilling wise. Cured boneless pork loins shall be to a temperature of not above 40 °F. or subjected to prescribed treatment for preparatory freezing, all parts of the destruction of trichinae prior to being muscle tissue of pork or product con- shipped from the establishment where taining such tissue shall be subjected cured. continuously to a temperature not (c) The treatment shall consist of higher than one of those specified in heating, refrigerating, or curing, as fol- table 1, the duration of such refrigera- lows: (1) Heating. (i) All parts of the pork tion at the specified temperature being muscle tissue shall be heated according dependent on the thickness of the meat to one of the time and temperature or inside dimensions of the container. combinations in the following table: TABLE 1—REQUIRED PERIOD OF FREEZING AT Minimum internal temperature TEMPERATURE INDICATED

De- Minimum Temperature °F. Group 1 (Days) Group 2 (Days) grees time Degrees fahrenheit centigrade 5 20 30 ¥10 10 20 120 ...... 49.0 21 hours. ¥20 6 12 122 ...... 50.0 9.5 hours. 124 ...... 51.1 4.5 hours. 126 ...... 52.2 2 hours. (i) Group 1 comprises product in sepa- 128 ...... 53.4 1 hour. rate pieces not exceeding 6 inches in 130 ...... 54.5 30 minutes. thickness, or arranged on separate 132 ...... 55.6 15 minutes. 134 ...... 56.7 6 minutes. racks with the layers not exceeding 6 136 ...... 57.8 3 minutes. inches in depth, or stored in crates or 138 ...... 58.9 2 minutes. 140 ...... 60.0 1 minute. boxes not exceeding 6 inches in depth, 142 ...... 61.1 1 minute. or stored as solidly frozen blocks not 144 ...... 62.2 Instant. exceeding 6 inches in thickness. (ii) Group 2 comprises product in (ii) Time and temperature shall be pieces, layers, or within containers, the monitored by a calibrated recording in- thickness of which exceeds 6 inches but strument that meets the requirements not 27 inches, and product in con- of paragraph (d) of this section, except for paragraph (c)(1)(iv). tainers including tierces, barrels, kegs, (iii) The time to raise product tem- and cartons having a thickness not ex- perature from 60 °F. to 120 °F shall not ceeding 27 inches. exceed 2 hours unless the product is (iii) The product undergoing such re- cured or fermented. frigeration or the containers thereof (iv) Time, in combination with tem- shall be so spaced while in the freezer peratures of 138 °F to 143 °F, need not as will insure a free circulation of air be monitored if the product’s minimum between the pieces of meat, layers, thickness exceeds 2 inches (5.1 cm) and blocks, boxes, barrels, and tierces in refrigeration of the product does not order that the temperature of the meat begin within 5 minutes of attaining 138 throughout will be promptly reduced to °F (58.9 °C). not higher than 5 °F., ¥10 °F., or ¥20 (v) The establishment shall use pro- °F., as the case may be. cedures which insure the proper heat- (iv) In lieu of the methods prescribed ing of all parts of the product. It is im- in Table 1, the treatment may consist portant that each piece of sausage, of commercial freeze drying or con- each ham, and other product treated by trolled freezing, at the center of the heating in water be kept entirely sub- meat pieces, in accordance with the merged throughout the heating period; times and temperatures specified in and that the largest pieces in a lot, the Table 2.

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TABLE 2—ALTERNATE PERIODS OF FREEZING AT shall any sausage be washed during any TEMPERATURES INDICATED prescribed period of drying. In the preparation of sausage, one of the fol- Maximum internal temperature lowing methods may be used: Degrees Minimum Degrees Fahrenheit centi- Time Method No. 1. The meat shall be ground or grade chopped into pieces not exceeding three- fourths of an inch in diameter. A dry-curing 0 ...... ¥17.8 106 hours. 1 ¥ ¥ mixture containing not less than 3 ⁄3 pounds 5 ...... 20.6 82 hours. of salt to each hundredweight of the ¥10 ...... ¥23.3 63 hours. ¥15 ...... ¥26.1 48 hours. unstuffed sausage shall be thoroughly mixed ¥20 ...... ¥28.9 35 hours. with the ground or chopped meat. After ¥25 ...... ¥31.7 22 hours. being stuffed, sausage having a diameter not ¥30 ...... ¥34.5 8 hours. exceeding 31⁄2 inches, measured at the time of ¥ ¥ 1 35 ...... 37.2 ⁄2 hour. stuffing, shall be held in a drying room not less than 20 days at a temperature not lower (v) During the period of refrigeration than 45 °F., except that in sausage of the va- the product shall be kept separate from riety known as pepperoni, if in casings not other products and in the custody of exceeding 13⁄8 inches in diameter measured at the Program in rooms or compart- the time of stuffing, the period of drying ments equipped and made secure with may be reduced to 15 days. In no case, however, shall the sausage be released from the an official Program lock or seal. The drying room in less than 25 days from the rooms or compartments containing time the curing materials are added, except product undergoing freezing shall be that sausage of the variety known as equipped with accurate thermometers pepperoni, if in casings not exceeding the placed at or above the highest level at size specified, may be released at the expira- which the product undergoing treat- tion of 20 days from the time the curing ma- ment is stored and away from refrig- terials are added. Sausage in casings exceeding 31⁄2 inches, but not exceeding 4 inches, in erating coils. After completion of the diameter at the time of stuffing, shall be prescribed freezing of pork to be used held in a drying room not less than 35 days in the preparation of product covered at a temperature not lower than 45 °F., and by paragraph (b) of this section the in no case shall the sausage be released from pork shall be kept under close super- the drying room in less than 40 days from the vision of an inspector until it is pre- time the curing materials are added to the pared in finished form as one of the meat. Method No. 2. The meat shall be ground or products enumerated in paragraph (b) chopped into pieces not exceeding three- of this section or until it is transferred fourths of an inch in diameter. A dry-curing under Program control to another offi- mixture containing not less than 31⁄3 pounds cial establishment for preparation in of salt to each hundredweight of the such finished form. unstuffed sausage shall be thoroughly mixed (vi) Pork which has been refrigerated with the ground or chopped meat. After as specified in this subparagraph may being stuffed, sausage having a diameter not exceeding 31⁄2 inches, measured at the time of be transferred in sealed railroad cars, stuffing, shall be smoked not less than 40 sealed motortrucks, sealed trailers, or hours at a temperature not lower than 80 °F., sealed closed containers to another of- and finally held in a drying room not less ficial establishment at the same or an- than 10 days at a temperature not lower than other location, for use in the prepara- 45 °F. In no case, however, shall the sausage tion of product covered by paragraph be released from the drying room in less (b) of this section. Such vehicles and than 18 days from the time the curing mate- containers shall be sealed and trans- rials are added to the meat. Sausage exceeding 31⁄2 inches, but not exceeding 4 inches, in ported between official establishments diameter at the time of stuffing, shall be in accordance with § 325.7 of this sub- held in a drying room, following smoking as chapter. above indicated, not less than 25 days at a (3) Curing—(i) Sausage. The sausage temperature not lower than 45 °F., but in no may be stuffed in animal casings, case shall the sausage be released from the hydrocellulose casings, or cloth bags. drying room in less than 33 days from the During any stage of treating the sau- time the curing materials are added to the meat. sage for the destruction of live Method No. 3. The meat shall be ground or trichinae, except as provided in Method chopped into pieces not exceeding three- 5, these coverings shall not be coated fourths of an inch in diameter. A dry-curing with paraffin or like substance, nor mixture containing not less than 31⁄3 pounds

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of salt to each hundredweight of the shall be in addition to the 35-day holding pe- unstuffed sausage shall be thoroughly mixed riod specified. with the ground or chopped meat. After ad- Method No. 5. The meat shall be ground or mixture with the salt and other curing mate- chopped into pieces not exceeding three- rials and before stuffing, the ground or fourths of an inch in diameter. A dry-curing chopped meat shall be held at a temperature mixture containing not less than 31⁄3 pounds not lower than 34 °F. for not less than 36 of salt to each hundredweight of the hours. After being stuffed, the sausage shall unstuffed sausage shall be thoroughly mixed be held at a temperature not lower than 34 with the ground or chopped meat. After °F. for an additional period of time sufficient being stuffed, the sausage shall be held for to make a total of not less than 144 hours not less than 65 days at a temperature not from the time the curing materials are added lower than 45 °F. The coverings for sausage to the meat, or the sausage shall be held for prepared according to this method may be the time specified in a pickle-curing medium coated at any stage of the preparation before of not less than 50° strength (salometer read- or during the holding period with paraffin or ing) at a temperature not lower than 44 °F. other substance approved by the Adminis- Finally, sausage having a diameter not ex- trator. ceeding 31⁄2 inches, measured at the time of Method No. 6. (A) Basic requirements. The stuffing, shall be smoked for not less than 12 meat shall be ground or chopped into pieces hours. The temperature of the smokehouse not exceeding three-fourths of an inch in di- during this period at no time shall be lower ameter. A dry-curing mixture containing not than 90 °F.; and for 4 consecutive hours of less than 3.33 pounds of salt to each hundred- this period the smokehouse shall be main- weight of the unstuffed sausage, excluding tained at a temperature not lower than 128 the weight of dry ingredients, shall be thor- °F. Sausage exceeding 31⁄2 inches, but not ex- oughly mixed with the ground or chopped ceeding 4 inches, in diameter at the time of meat. After the curing mixture has been stuffing shall be smoked, following the pre- added, the sausage shall be held for two time scribed curing, for not less than 15 hours. periods, a holding period and a drying period. The temperature of the smokehouse during The holding period will be for a minimum of the 15-hour period shall at no time be lower 48 hours at a room temperature not lower ° than 90 F., and for 7 consecutive hours of than 35 °F. This holding period requirement this period the smokehouse shall be main- may be fulfilled totally or in part before the tained at a temperature not lower than 128 drying period and then the remainder, if any, ° F. In regulating the temperature of the after the drying period or as an extension of smokehouse for the treatment of sausage the drying period. During the drying period, under this method, the temperature of 128 the sausage shall be held in a drying room at ° F. shall be attained gradually during a pe- a temperature not lower than 50 (10.0 °F. (10.0 riod of not less than 4 hours. °C) for a period of time determined by Tables Method No. 4. The meat shall be ground or 3A, 3B, and 4. The length of the drying pe- chopped into pieces not exceeding one-fourth riod, established in (c)(3)(i)(A), may be modi- of an inch in diameter. A dry-curing mixture fied as provided in paragraphs (c)(3)(i)(B) and containing not less than 21⁄2 pounds of salt to (c)(3)(i)(C) of this section. each hundredweight of the unstuffed sausage shall be thoroughly mixed with the ground or chopped meat. After admixture with the TABLE 3A—SAUSAGE DRYING ROOM TIMES BY salt and other curing materials and before METHOD NO. 6 stuffing, the ground or chopped sausage shall Days in be held as a compact mass, not more than 6 Diameter of casing at time of stuffing 1 drying inches in depth, at a temperature not lower room 2 than 36 °F. for not less than 10 days. At the termination of the holding period, the sau- Up to: 1 inches ...... 14 sage shall be stuffed in casings or cloth bags 11⁄2 inches ...... 15 1 not exceeding 3 ⁄3 inches in diameter, meas- 2 inches ...... 16 ured at the time of stuffing. After being 21⁄2 inches ...... 18 stuffed, the sausage shall be held in a drying 3 inches ...... 20 room at a temperature not lower than 45 °F. 31⁄2 inches ...... 23 for the remainder of a 35-day period, meas- 4 inches ...... 25 1 ured from the time the curing materials are 4 ⁄2 inches ...... 30 5 inches ...... 35 added to the meat. At any time after stuff- 1 5 ⁄2 inches ...... 43 ing, if the establishment operator deems it 6 inches ...... 50 desirable, the product may be heated in a 1 The drying room times for flattened or oval sausages shall water bath for a period not to exceed 3 hours use a diameter derived by measuring the circumference and at a temperature not lower than 85 °F., or dividing by 3.14 (pi). subjected to smoking at a temperature not 2 Drying room time may be modified as set forth in Tables 3B and 4. lower than 80 °F., or the product may be both heated and smoked as specified. The time (B) Reduction in Drying Room Time. During consumed in heating and smoking, however, the holding period, the sausage may be

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smoked or fermented. If the temperature is subsequent drying room times prescribed for increased to 70 °F. (21.1 °C) or higher, while this method may be reduced according to the the sausage is being held after adding curing schedule in Table 3B. No interpolation of val- materials but before the drying period, the ues is permissible.

TABLE 3B—PERCENTAGE REDUCTION IN DRYING ROOM TIME (TABLE 3A) PERMITTED BY HOLDING TIMES AND TEMPERATURES PRIOR TO DRYING 1

Minimum Temperature 2 Minimum Time 70 °F 75 °F 80 °F 85 °F 90 °F 95 °F 100 °F 105 °F 110 °F 120 °F 21.1 °C 23.9 °C 26.7 °C 29.5 °C 32.2 °C 35.0 °C 37.9 °C 40.6 °C 43.3 °C 48.9 °C

24 hours...... 4 5 8 10 15 23 37 57 90 3 100 48 hours...... 9 12 18 25 35 49 88 3 100 3 100 100 72 hours...... 14 19 28 39 55 74 3 100 100 100 100 96 hours...... 19 26 38 53 75 98 100 100 100 100 120 hours...... 24 33 48 67 95 3 100 100 100 100 100 1 In computing the days to be deducted, the number with any fraction shall be rounded to the next lower whole number and shall be deducted from the required total drying time. Example: Sausage stuffed in 3″ diameter casing requires 20 days in the drying room (from Drying Room Times, Table 3A). If allowed to ferment, after addition of curing materials, at 80 °F. for 48 hours, the 20 day drying time may be reduced 18% (from Table 3B). Eighteen percent of 20 day equals 3.6 days. Twenty days minus 3 days equals 17 days. The total drying time required in the drying room, therefore, will be 17 days. 2 Either room temperature or internal product temperature shall be used for sausages that will be subsequently dried to a moisture-protein ratio of 2.3:1 or less. Internal product temperature shall be used for all other sausages. 3 Trichinae will be destroyed during fermentation or smoking at the temperature and length of time indicated. Therefore, no drying room period is required for products so treated.

(C) Reduced Salt Content—Drying Room Therefore, the sausage drying time must be increased by Times. Salt content of less than 3.33 pounds 13 percent. 2 In computing the days to be added to the required total for each hundredweight of sausage formula- drying time, fractions shall be rounded to the next higher tion, excluding dry ingredients, (such as whole number and added to the required total drying time. Ex- salts, sugars, and spices), may be permitted ample: Sausage stuffed in 31⁄2 inch diameter casing requires 23 days in the drying room (from Drying Room Times). If the provided the drying time is increased accord- quantity of salt added per hundredweight of sausage is 2 ing to the schedule contained in Table 4. pounds instead of 3.33 pounds, the drying room time must be increased by 40 percent (from Reduced Salt Content-Drying TRICHINA TREATMENT OF SAUSAGE BY METHOD Room Times), or 9.2 days. The 9.2 is rounded up to 10 days and is added to the 23 days to equal 33 days. The total dry- NO. 6; ing time required in the drying room, therefore, will be 33 days. TABLE 4—REDUCED SALT CONTENT—DRYING Method No. 7, Dry Sausages. (A) General Re- ROOM TIMES quirements. The establishment shall use meat [Required percentage increase in drying room time (table 3A) particles reduced in size to no more than 1/ for added salt of less than 3.33 pounds per hundredweight of sausage] 4 inch in diameter. The establishment shall add a curing mixture containing no less than Increase 2.7 pounds of salt per hundred pounds of meat in drying Minimum pounds of salt added to sausage 1 and mix it uniformly throughout the prod- room time 2 uct. The establishment shall hold, heat, and dry the product according to paragraph (B) 3.3 ...... 1 or (C) below. 3.2 ...... 4 (B) Holding, Heating, and Drying Treatment, 3.1 ...... 7 Large Sausages. Except as permitted in (C) 3.0 ...... 10 2.9 ...... 13 below, the establishment shall subject sau- 2.8 ...... 16 sages in casings not exceeding 105 mm in di- 2.7 ...... 19 ameter, at the time of stuffing, to all of the 2.6 ...... 22 following minimum chamber temperatures 2.5 ...... 25 and time periods. 2.4 ...... 28 2.3 ...... 31 2.2 ...... 34 TREATMENT SCHEDULE FOR SAUSAGES 105 MIL- 2.1 ...... 37 LIMETERS (41⁄8 INCHES) OR LESS IN DIAMETER 2.0 ...... 40 Minimum chamber temperature 1 Calculate the salt content for column 1 as follows: Multiply Minimum time (hours) the pounds of salt in the sausage formulation by 100. Then di- (°F) (°C) vide this number by the total weight of sausage formulation minus the weight of dry ingredients and round down to the next lowest 0.1%. Percents may be substituted for pounds. 50 10 12 Example: 120 lbs. pork, 3.56 lbs. salt, 2 lbs. spices, 0.5 lbs. 90 32.2 1 wine, 1 lb. water and starter culture, 0.8 lbs. sugar, .012 lbs. 100 37.8 1 sodium nitrite total weight is 127.872 lbs. 110 43.3 1 (3.56×100)/(127.872¥3.56¥2¥.8¥.012)=356/121.5=2.93 120 48.9 1

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TREATMENT SCHEDULE FOR SAUSAGES 105 MIL- pounds of salt per hundredweight of LIMETERS (41⁄8 INCHES) OR LESS IN DIAME- meat for a period of not less than 18 TER—Continued days at a temperature not lower than 36 °F. If the curing mixture is applied Minimum chamber temperature Minimum time to the butts by the process known as (°F) (°C) (hours) churning, a small quantity of pickle may be added. During the curing period 125 51.7 7 the butts may be overhauled according Following the preceding treatment, the es- to any of the usual processes of over- tablishment shall dry the sausages at a tem- hauling, including the addition of pick- perature not lower than 50 °F (10 °C) for not le or dry salt if desired. The butts shall less than 7 days. not be subjected during or after curing (C) Heating and Drying Treatment, Small to any treatment designed to remove Sausages. Alternatively, the establishment salt from the meat, except that super- may subject sausages in casings not exceed- ficial washing may be allowed. After ing 55 mm in diameter, at the time of stuff- being stuffed, the product shall be held ing, to all of the following minimum chamber temperatures and time periods. in a drying room not less than 35 days at a temperature not lower than 45 °F. TREATMENT SCHEDULE FOR SAUSAGES 55 MILLI- (iv) Hams and pork shoulder picnics. In METERS (21⁄8 INCHES) OR LESS IN DIAMETER the curing of hams and pork shoulder picnics, one of the methods below shall Minimum chamber temperature Minimum time be used. For calculating days per (°F) (°C) (hours) pound, the establishment shall use the weight of the heaviest ham or picnic in 50 10 12 the lot. 100 37.8 1 125 51.7 6 Method No. 1. The hams and pork shoulder picnics shall be cured by a dry-salt curing Following the preceding heat treatment, the process not less than 40 days at a tempera- establishment shall dry the sausages at a ture no lower than 36 °F. The products shall temperature not lower than 50 °F (10 °C) for be laid down in salt, not less than 4 pounds not less than 4 days. to each hundredweight of product, the salt (ii) Capocollo (capicola, capacola). being applied in a thorough manner to the lean meat of each item. When placed in cure, Boneless pork butts for capocollo shall the products may be pumped with pickle if be cured in a dry-curing mixture con- desired. At least once during the curing proc- taining not less than 41⁄2 pounds of salt ess, the products shall be overhauled (turned per hundredweight of meat for a period over for the application of additional cure) of not less than 25 days at a tempera- and additional salt applied, if necessary, so ture not lower than 36 °F. If the curing that the lean meat of each item is thor- materials are applied to the butts by oughly covered. After removal from cure, the the process known as churning, a small products may be soaked in water at a temperature not higher than 70 °F for not more quantity of pickle may be added. Dur- than 15 hours, during which time the water ing the curing period the butts may be may be changed once, but they shall not be overhauled according to any of the subjected to any other treatment designed to usual processes of overhauling, includ- remove salt from the meat except that su- ing the addition of pickle or dry salt if perficial washing may be allowed. The prod- desired. The butts shall not be sub- ucts shall finally be dried or smoked at a jected during or after curing to any time and temperature not less than a com- treatment designed to remove salt bination prescribed in Table 5 of Method No. 3. from the meat, except that superficial Method No. 2. [Reserved] washing may be allowed. After being Method No. 3. (A) Curing. (Other than bag stuffed, the product shall be smoked curing): Establishments shall cure hams and for a period of not less than 30 hours at shoulders by using a cure mixture containing a temperature not lower than 80 °F., not less than 70 percent salt by weight to and shall finally be held in a drying cover all exposed muscle tissue and to pack room not less than 20 days at a tem- the hock region. Total curing time consists perature not lower than 45 °F. of a mandatory cure contact time and an optional equalization time. (iii) Coppa. Boneless pork butts for (B) Cure Contact Time. This is the cure con- coppa shall be cured in a dry-curing tact period, during which the establishment mixture containing not less than 41⁄2 shall keep exposed muscle tissue coated with

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the cure mixture at least 28 days but for no curing time. If the product temperature ex- less than 1.5 days per pound of ham or shoul- ceeds 45 °F (7.2 °C) within the first period of der. Overhaul is optional so long as the ex- 1.5 days per pound of an uncured ham or posed muscle tissue remains coated with cur- shoulder or if it exceeds 60 °F (15.6 °C) for the ing mixture. remainder of the curing period, the estab- (C) Equalization. The establishment may lishment shall cool the product back to the provide an equalization period after the min- 45 °F (7.2 °C) maximum during the first pe- imum cure contact period in (B) above to riod or 55 °F (12.8 °C) maximum during the permit the absorbed salt to permeate the remainder of the period. product’s inner tissues. Equalization is the (3) The establishment shall begin curing time after the excess cure has been removed product only between the dates of December from the product at the end of the cure con- 1 and February 13. The room temperature tact period until the product is placed in the need not be controlled, but the establish- drying room and the drying period begins. The total curing time (equalization plus cure ment shall monitor and record daily room contact) shall be at least 40 days and in no temperatures, and days in which the room ° ° case less than 2 days per pound of an uncured temperature drops below 35 F (1.7 C) shall ham or shoulder. not be counted as curing time. (D) Removing Excess Cure. After the re- (G) Drying. After the curing period, estab- quired cure contact period, the establish- lishments shall use one of three procedures ment may remove excess cure mixture from for drying: the product’s surface mechanically or by (1) The establishment shall subject the rinsing up to 1 minute with water, but not by product to a controlled room temperature soaking. for a minimum time and minimum tempera- (E) Bag Curing. Bag curing is a traditional ture combination prescribed in Table 5 or for ham curing technique in which the manufac- a set of such combinations in which the total turer wraps the ham and all of the cure mix- of the fractional periods (in column 4 of ture together in kraft paper then hangs them Table 5) exceeds 1.5. individually. The paper keeps the extra cure (2) Establishments using uncontrolled mixture in close contact with the product room temperatures shall monitor and record making reapplication of salt unnecessary, the internal product temperature. The dry- and it protects the product from mites and ing period shall be complete when, from the insects. Establishments may employ the bag days which can be counted as curing time, curing method as an alternative to (A) through (D) above. An establishment which one of the time/temperature combinations of elects to use the bag curing method shall Table 5 is satisfied or when the total of the apply a cure mixture containing at least 6 fractional values for the combinations ex- pounds of salt per 100 pounds of uncured ceeds 1.5. product. The establishment shall rub the (3) Establishments using uncontrolled curing mixture into the exposed muscle tis- room temperatures shall dry the product for sue, pack the hock region with the curing a minimum of 160 days including the entire mixture, and use uncoated wrapping paper to months of June, July, and August. This pro- wrap the product together with any remain- cedure is obviously dependent on local cli- ing curing mixture. The bag cured product matic conditions and no problem exists with shall remain wrapped throughout the curing respect to current producers who use this period and may or may not remain wrapped procedure. Future applicants shall dem- during the drying period. In any case, the onstrate that their local monthly average curing period shall be at least 40 days but temperatures and the local monthly min- not less than 2 days per pound of an uncured imum temperatures are equal to or warmer ham or shoulder. After curing, the cured than the normal average temperatures and product shall be exposed to a drying time normal minimum temperatures compiled by and temperature prescribed in Table 5. the National Oceanic and Atmospheric Ad- (F) Curing Temperature. During the curing ministration for Boone, North Carolina, sta- period the establishment shall use one of the tion 31–0977, 1951 through 1980. following procedures: (1) The establishment shall control the MONTHLY TEMPERATURES (°F) FOR BOONE NC, room temperature at not less than 35 °F (1.7 1951–1980 °C) nor greater than 45 °F (7.2 °C) for the first 1.5 days per pound of an uncured ham or Jan. Feb. Mar. Apr. May June July Aug. Sep. shoulder, and not less than 35 °F (1.7 °C) nor greater than 60 °F (15.6 °C) for the remainder Normal average temperatures of the curing period. (2) The establishment shall monitor and 32.2 34.1 41.3 51.2 59.1 65.1 68.3 67.5 61.6 record daily product temperature. The room temperature need not be controlled but days Normal minimum temperatures on which the product temperature drops 22.8 24.2 30.8 39.6 48.1 54.7 58.5 57.6 51.6 below 35 °F (1.7 °C) shall not be counted as

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Drying Times and Temperatures for temperature methods for drying listed in Trichina Inactivation in Hams and Method No. 3 of this subparagraph. Shoulders Method No. 5 (A) Curing. The establishment shall cure the ham to a minimum brine concentration of 6 percent by the end of the dry- TABLE 5—MINIMUM DRYING DAYS AT A MINIMUM ing period. Brine concentration is calculated TEMPERATURE* as 100 times the salt concentration divided Minimum Drying Temperature Fractional by the sum of the salt and water concentra- Minimum days period for tions. Degrees fahr- Degrees at drying tem- one day of enheit centigrade perature drying Percent brine = 100 × [salt] / ([salt] + [water])

130 ...... 54.4 1.5 .67 The Agency will accept the brine con- 125 ...... 51.7 2 .50 centration in the biceps femoris as a reason- 120 ...... 48.9 3 .33 able estimate of the minimum brine con- 115 ...... 46.1 4 .25 centration in the ham. 110 ...... 43.3 5 .20 (B) Drying and Total Process Times. The es- 105 ...... 40.6 6 .17 tablishment shall dry the cured ham at a 100 ...... 37.8 7 .14 ° ° 95 ...... 35.0 9 .11 minimum temperature of 55 F (13 C) for at 90 ...... 32.2 11 .091 least 150 days. The total time of drying plus 85 ...... 29.4 18 .056 curing shall be at least 206 days. 80 ...... 26.7 25 .040 (C) Ensuring an Acceptable Internal Brine 75 ...... 23.9 35 .029 Concentration. (1) To establish compliance, * Interpolation of these times or temperatures is not accept- the establishment shall take product sam- able; establishments wishing to use temperatures or times not ples from the first 12 lots of production as in this Table shall first validate their efficacy as provided by follows: From each lot, 318.10(c)(4) of this section. (i) One sample shall be taken from each of Method No. 4. (A) Cure: Establishments 5 or more hams; shall cure hams and shoulders by using a (ii) Each sample shall be taken from the cure mixture containing not less than 71.5 biceps femoris. As an alternative to the use percent salt by weight to cover all exposed of the biceps femoris, the Agency shall con- muscle tissue and to pack the hock region. sider other method(s) of sampling the dry- Establishments may substitute potassium cured hams to determine the minimum in- chloride (KCl) for up to half of the required ternal brine concentration, as long as the es- salt on an equal weight basis. tablishment proposes it and submits data (B) Curing. Establishments shall apply the and other information to establish its suffi- cure at a rate not less than 5.72 pounds of ciency to the Director of the Processed Prod- salt and KCl per hundred pounds of fresh ucts Inspection Division; meat. The cure shall be applied in either (iii) Each sample shall weigh no less than three or four approximately equal amounts 100 grams; (two or three overhauls) at separate times (iv) The samples shall be combined as one during the first 14 days of curing. composite sample and sealed in a water (C) Cure Contact Time. Establishments shall vapor proof container; keep the product in contact with the cure (v) The composite sample shall be sub- mixture for no less than 2 days per pound of mitted to a laboratory accredited under the an uncured ham or shoulder but for at least provisions of § 318.21 to be analyzed for salt 30 days. Establishments shall maintain the and water content using methods from the curing temperature at no less than 35 °F (1.7 ‘‘Official Methods of Analysis of the Associa- °C) during the cure contact time. tion of Official Analytical Chemists (D) Equalization. After the cure contact pe- (AOAC),’’ 15th Edition, 1990, Section 983.18 riod, establishments shall provide an added (page 931) and Section 971.19 (page 933) which equalization period of no less than 1 day per are incorporated by reference. This incorpo- pound of an uncured ham or shoulder but at ration by reference was approved by the Di- least 14 days. Equalization is the time after rector of the Federal Register in accordance the excess cure has been removed from the with 5 U.S.C. 552(a) and 1 CFR part 51. Copies product, the end of the cure contact period, may be obtained from the Association of Of- and before the drying period begins. Estab- ficial Analytical Chemists, suite 400–BW, 2200 lishments may substitute additional cure Wilson Boulevard, Arlington, VA 22201–3301. contact days for an equal number of equali- Copies may be inspected at the Office of the zation days. FSIS Hearing Clerk, room 3171, South Agri- (E) Removing Excess Cure. After the re- culture Building, Food Safety and Inspection quired cure contact period, the establish- Service, U.S. Department of Agriculture, ment may remove excess cure mixture from Washington, DC 20250 or at the National Ar- the product’s surface mechanically or by chives and Records Administration (NARA). rinsing up to 1 minute with water, but not by For information on the availability of this soaking. material at NARA, call 202–741–6030, or go to: (F) Drying. After the curing period, estab- http://www.archives.gov/federallregister/ lishments shall use one of the controlled codeloflfederallregulations/

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ibrllocations.html. If the time between sam- sider other methods of sampling the dry- pling and submittal of the composite sample cured hams to determine internal brine con- to the accredited laboratory will exceed 8 centration, as long as the establishment pro- hours, then the establishment shall freeze poses it and submits data and other informa- the composite sample immediately after the tion to establish its sufficiency to the Direc- samples are combined; tor of the Processed Products Inspection Di- (vi) Once the laboratory results for the vision; composite sample are received, the manufac- (iii) Each sample shall weigh no less than turer shall calculate the internal brine con- 100 grams; centration by multiplying the salt con- (iv) The samples shall be combined as one centration by 100 and then dividing that fig- composite sample and sealed in a water ure by the sum of the salt and water con- vapor proof container; centrations; (v) The composite sample shall be sub- (vii) Compliance is established when the mitted to a laboratory accredited under the samples from the first 12 lots of production provisions of § 318.21 to be analyzed for salt have a minimum internal brine concentra- and water content using methods from the tion of 6 percent. Lots being tested to estab- ‘‘Official Methods of Analysis of the Associa- lish compliance shall be held until the inter- tion of Official Analytical Chemists nal brine concentration has been determined (AOAC),’’ 15th Edition, 1990, section 983.18 and found to be at least 6 percent. If the min- (page 931) and section 971.19 (page 933) which imum internal brine concentration is less are incorporated by reference. This incorpo- than 6 percent, the lot being tested shall be ration by reference was approved by the Di- held until the establishment brings the lot rector of the Federal Register in accordance into compliance by further processing. with 5 U.S.C. 552(a) and 1 CFR part 51. Copies (2) To maintain compliance, the establish- may be obtained from the Association of Of- ment shall take samples, have the samples ficial Analytical Chemists, suite 400–BW, 2200 analyzed, and perform the brine calculations Wilson Boulevard, Arlington, VA 22201–3301. as set forth above from one lot every 13 Copies may be inspected at the Office of the weeks. Lots being tested to maintain compli- FSIS Hearing Clerk, room 3171, South Agri- ance shall not be held. If the minimum inter- culture Building, Food Safety and Inspection nal brine concentration is less than 6 percent Service, U.S. Department of Agriculture, in a lot being tested to maintain compliance, Washington, DC 20250 or at the National Ar- the establishment shall develop and propose chives and Records Administration (NARA). steps acceptable to FSIS to ensure that the For information on the availability of this process is corrected. material at NARA, call 202–741–6030, or go to: (3) Accredited laboratory results and the http://www.archives.gov/federallregister/ brine calculations shall be placed on file at codeloflfederallregulations/ the establishment and available to Program ibrllocations.html. If the time between sam- employees for review. pling and submittal of the composite sample Method No. 6 (A) Curing. The establishment to the accredited laboratory will exceed 8 shall cure the ham to a minimum brine con- hours, then the establishment shall freeze centration of 6 percent by the end of the dry- the composite sample immediately after the ing period. Brine concentration is calculated samples are combined; as 100 times the salt concentration divided (vi) Compliance is established when the by the sum of the salt and water concentra- samples from the first 12 lots of production tions. have a minimum internal brine concentration of 6 percent. Lots being tested to estab- × Percent brine = 100 [salt] / ([salt] + [water]) lish compliance shall be held until the inter- The Agency will accept the brine con- nal brine concentration has been determined centration in the biceps femoris as a reason- and found to be at least 6 percent. If the min- able estimate of the minimum brine con- imum internal brine concentration is less centration. than 6 percent, the lot being tested shall be (B) Drying and Total Process Times. The es- held until the establishment brings the lot tablishment shall dry the cured ham at a into compliance by further processing. minimum temperature of 110 °F (43 °C) for at (2) To maintain compliance, the establish- least 4 days. The total time of drying plus ment shall take samples, have the samples curing shall be at least 34 days. analyzed, and perform the brine calculations (c) Ensuring an Acceptable Internal Brine as set forth above from one lot every 13 Concentration. (1) To establish compliance weeks. Lots being tested to maintain compli- the establishment shall take product sam- ance shall not be held. If the minimum inter- ples from the first 12 lots of production as nal brine concentration is less than 6 percent follows: From each lot, in a lot being tested to maintain compliance, (i) One sample shall be taken from each of the establishment shall develop and propose 5 or more hams; steps acceptable to FSIS to ensure that the (ii) Each sample shall be taken from the process is corrected. biceps femoris. As an alternative to the use (3) Accredited laboratory results and the of the biceps femoris, the Agency will con- brine calculations shall be placed on file in

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the establishment and available to Program thorized to approve for use in sausage employees for review. smokehouses, drying rooms, and other (v) Boneless pork loins and loin ends. compartments, such automatic record- In lieu of heating or refrigerating to ing thermometers as are found to give destroy possible live trichinae in satisfactory service and to disapprove boneless loins, the loins may be cured and require discontinuance of use, for for a period of not less than 25 days at purposes of the regulations in this sub- a temperature not lower than 36 °F. by chapter, any thermometers (including the use of one of the following meth- any automatic recording thermom- ods: eters) of the establishment that are found to be inaccurate or unreliable. Method No. 1. Application of a dry-salt curing mixture containing not less than 5 (e) The requirements for using the pounds of salt to each hundredweight of pooled sample digestion technique to meats. analyze pork for the presence of tri- Method No. 2. Application of a pickle solu- china cysts are: tion of not less than 80° strength (salometer) (1) The establishment shall submit on the basis of not less than 60 pounds of for the approval of the Regional Direc- pickle to each hundredweight of meat. tor its proposed procedure for identi- Method No. 3. Application of a pickle solution added to the dry-salt cure prescribed as fying and pooling carcasses, collecting Method No. 1 in this subdivision (v) provided and pooling samples, testing samples the pickle solution is not less than 80° (including the name and address of the strength (salometer). laboratory), communicating test re- After removal from cure, the loins may be sults, retesting individual carcasses, soaked in water for not more than 1 hour at and maintaining positive identification a temperature not higher than 70 °F. or and clear separation of pork found to washed under a spray but shall not be sub- be trichina-free from untested pork or jected, during or after the curing process, to any other treatment designed to remove trichina-positive pork. salt. (2) The establishment shall use the Following curing, the loins shall be services of a laboratory approved by smoked for not less than 12 hours. The min- the Administrator for all required test- imum temperature of the smokehouse during ing. Such approval shall be based on this period at no time shall be lower than 100 adequacy of facilities, reagents, and °F., and for 4 consecutive hours of this period the smokehouse shall be maintained at a equipment, and on demonstration of temperature not lower than 125 °F. continuing competency and reliability Finally, the product shall be held in a dry- in performing the pooled sample diges- ing room for a period of not less than 12 days tion technique for trichinae. at a temperature not lower than 45 °F. (3) The establishment shall sample no (4) The Administrator shall consider less than 5 grams of diaphragm muscle additional processing methods upon pe- or tongue tissue from each carcass or tition by manufacturers, and shall ap- no less than 10 grams of other muscle prove any such method upon his/her de- tissue. Samples may be pooled but a termination that it can be properly pool shall not consist of more than 100 monitored by an inspector and that the grams of sample. Sampling and sample safety of such methods is adequately preparation are subject to inspection documented by data which has been de- supervision. veloped by following an experimental (4) Pork or products made from test- protocol previously reviewed and ac- ed pork shall not be released as tri- cepted by the Department. china free from the official establish- (d) General instructions: When nec- ment without treatment until the in- essary to comply with the require- spector in charge receives a laboratory ments of this section, the report that the tested pork is free of smokehouses, drying rooms, and other trichina cysts. compartments used in the treatment of (f) Approval of other tests for trichinosis pork to destroy possible live trichinae in pork. The Administrator shall con- shall be suitably equipped, by the oper- sider any additional analytical method ator of the official establishment, with for trichinosis upon petition by a man- accurate automatic recording ther- ufacturer, and may approve that meth- mometers. Circuit supervisors are au- od upon the determination that it will

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detect at least 98 percent of swine bear- article may be admitted into any edi- ing cysts present at a tissue density ble products department of an official equal to or less than one cyst per gram establishment only if they are U.S. In- of muscle from the diaphragm pillars spected and Passed. Products within at a 95 percent confidence level. Any § 314.11 of this subchapter or parts of such petitions shall be supported by carcasses of kinds not permitted under any data and other information that the regulations in this subchapter to be the Administrator finds necessary. No- prepared for human food (e.g., lungs or tice of any approval shall be given in intestines), which are produced at any the FEDERAL REGISTER, and the ap- official establishment, may be brought proved method will be incorporated into this section. into the inedible products department of any official establishment for use in [35 FR 15586, Oct. 3, 1970, as amended at 38 FR uninspected articles under this section. 31517; Nov. 15, 1973; 39 FR 40580, Nov. 19, 1974; The uninspected article may be stored 50 FR 5229, Feb. 7, 1985; 50 FR 48075, Nov. 21, 1985; 52 FR 12517, Apr. 17, 1987; 57 FR 27874, in, and distributed from, edible product June 22, 1992; 57 FR 33633, July 30, 1992; 57 FR departments: Provided, That adequate 56440, Nov. 30, 1992] facilities are furnished, there is no interference with the maintenance of § 318.11 [Reserved] sanitary conditions, and such article is § 318.12 Manufacture of dog food or properly identified. similar uninspected article at offi- (b) When dog food or similar cial establishments. uninspected article is manufactured in (a) When dog food, or similar a part of an official establishment uninspected article is manufactured in other than an edible product depart- an edible product department, there ment, the area in which the article is shall be sufficient space allotted and manufactured shall be separated from adequate equipment provided so that edible product departments in the man- the manufacture of the uninspected ar- ner required for separation between ed- ticle in no way interferes with the han- ible product departments and inedible dling or preparation of edible products. product departments. Sufficient space Where necessary to avoid adulteration must be allotted and adequate equip- of edible products, separate equipment ment provided so that the manufacture shall be provided for the uninspected of the uninspected article does not article. To assure the maintenance of interfere with the proper functioning of sanitary conditions in the edible prod- the other operations at the establish- uct departments, the operations inci- ment. Except as provided in § 314.11 of dent to the manufacture of the this subchapter, nothing in this para- uninspected article will be subject to the same sanitary requirements that graph shall be construed as permitting apply to all operations in edible prod- any deviation from the requirement uct departments. The manufacture of that dead animals, condemned prod- the uninspected article shall be limited ucts, and similar materials of whatever to those hours during which the estab- origin, must be placed in the inedible lishment operates under inspectional product rendering equipment, and supervision; and there shall be no han- without undue delay. The manufacture dling, other than receiving at the offi- of the uninspected article must be such cial establishment, of any of the prod- as not to interfere with the mainte- uct ingredient of the uninspected arti- nance of general sanitary conditions on cle, other than during the regular the premises, and it shall be subject to hours of inspection. The materials used inspectional supervision similar to in the manufacture of the uninspected that exercised over other inedible prod- article shall not be used so as to inter- uct departments. There shall be no fere with the inspection of edible prod- movement of any product from an ined- uct or the maintenance of sanitary ible product department to any edible conditions in the department or render product department. Trucks, barrels, any edible product adulterated. The and other equipment shall be cleaned meat, meat byproducts, and meat food before being returned to edible product product ingredients of the uninspected

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departments from inedible product de- dium hypochlorite containing approxi- partments. Unoffensive material pre- mately one-half of 1 percent available pared outside edible product depart- chlorine (5,000 p/m) or other equivalent ments may be stored in, and distrib- disinfectant approved by the Adminis- uted from, edible product departments trator 1 shall be applied to the surface only if packaged in clean, properly of the rooms and equipment and rinsed identified, sealed containers. with potable water before use. (c) Animal food shall be distin- (c) Hermetically sealed containers of guished from articles of human food, so product which have been contaminated as to avoid distribution of such animal by polluted water shall be examined food as human food. To accomplish this, such animal food shall be labeled promptly by the official establishment or otherwise identified in accordance under supervision of an inspector and with § 325.11(d) of this subchapter. rehandled as follows: (1) Separate and condemn all product [35 FR 15586, Oct. 3, 1970, as amended at 36 FR in damaged or extensively rusted con- 11639, June 17, 1971; 53 FR 24679, June 30, 1988] tainers. § 318.13 Mixtures containing product (2) Remove paper labels and wash the but not amendable to the Act. remaining containers in warm soapy Mixtures containing product but not water, using a brush where necessary classed as a meat food product under to remove rust or other foreign mate- the Act shall not bear the inspection rial. Disinfect these containers by ei- legend or any abbreviation or represen- ther of the following methods: tation thereof unless manufactured (i) Immerse in a solution of sodium under the food inspection service pro- hypochlorite containing not less than vided for in part 350 of subchapter B of 100 p/m of available chlorine or other this chapter. When such mixtures are equivalent disinfectant approved by manufactured in any part of an official the Administrator, 1 rinse in potable establishment, the sanitation of that water, and dry thoroughly; or part of the establishment shall be su- (ii) Immerse in 212 °F. water, bring pervised by Program employees, and temperature of the water back to 212 the manufacture of such mixtures shall °F. and maintain the temperature at not cause any deviation from the re- 212 °F. for 5 minutes, then remove con- quirement of § 318.1. tainers from water and cool them to 95 [35 FR 15586, Oct. 3, 1970, as amended at 38 FR °F. and dry thoroughly. 29215, Oct. 23, 1973] (3) After handling as described in paragraph (c)(2) of this section, the § 318.14 Adulteration of product by polluted water; procedure for han- containers may be relacquered, if nec- dling. essary, and then relabeled with ap- (a) In the event there is polluted proved labels applicable to the product water (including but not limited to therein. flood water) in an official establish- (4) The identity of the canned prod- ment, all products and ingredients for uct shall be maintained throughout all use in the preparation of such products stages of the rehandling operations to that have been rendered adulterated by insure correct labeling of the con- the water shall be condemned. tainers. (b) After the polluted water has re- [35 FR 15586, Oct. 3, 1970, as amended at 38 FR ceded from an official establishment, 34455, Dec. 14, 1973] all walls, ceilings, posts, and floors of the rooms and compartments involved, including the equipment therein, shall, under the supervision of an inspector, be cleaned thoroughly by the official 1 A list of approved disinfectants is avail- establishment personnel. An adequate able upon request to Scientific Services, supply of hot water under pressure is Meat and Poultry Inspection Program, Food essential to make such cleaning effec- Safety and Inspection Service, U.S. Depart- tive. After cleaning, a solution of so- ment of Agriculture, Washington, DC 20250.

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§ 318.15 Tagging chemicals, preserva- upon request made to the Adminis- tives, cereals, spices, etc., ‘‘U.S. re- trator. tained.’’ When any chemical, preservative, ce- § 318.17 Requirements for the produc- real, spice, or other substance is in- tion of cooked beef, roast beef, and tended for use in an official establish- cooked corned beef products. ment, it shall be examined by a Pro- (a) Cooked beef, roast beef, and gram employee and if found to be unfit cooked corned beef products must be or otherwise unacceptable for the use produced using processes ensuring that intended, or if final decision regarding the products meet the following per- acceptance is deferred pending labora- formance standards: tory or other examination, the em- (1) Lethality. A 6.5-log10 reduction of ployee shall attach a ‘‘U.S. retained’’ Salmonella or an alternative lethality tag to the substance or container that achieves an equivalent probability thereof. The substance so tagged shall that no viable Salmonella organisms re- be kept separate from other substances as the circuit supervisor may require main in the finished product, as well as and shall not be used until the tag is the reduction of other pathogens and removed, and such removal shall be their toxins or toxic metabolites nec- made only by a Program employee essary to prevent adulteration, must be after a finding that the substance can demonstrated to be achieved through- be accepted, or, in the case of an unac- out the product. The lethality process ceptable substance, when it is removed must include a cooking step. Con- from the establishment. trolled intermediate step(s) applied to raw product may form part of the basis § 318.16 Pesticide chemicals and other for the equivalency. residues in products. (2) Stabilization. There can be no mul- (a) Nonmeat ingredients. Residues of tiplication of toxigenic microorga- pesticide chemicals, food additives and nisms such as Clostridium botulinum, color additives or other substances in and no more than 1-log10 multiplication or on ingredients (other than meat, of Clostridium perfringens within the meat byproducts, and meat food prod- product. ucts) used in the formulation of prod- (b) For each product produced using a ucts shall not exceed the levels per- process other than one conducted in ac- mitted under the Federal Food, Drug, cordance with the Hazard Analysis and and Cosmetic Act, and such nonmeat Critical Control Point (HACCP) system ingredients must otherwise be in compliance with the requirements under requirements in part 417 of this chap- that Act. ter, an establishment must develop and (b) Products, and meat, meat byproduct, have on file and available to FSIS, a or other meat food product ingredients. process schedule, as defined in § 301.2 of Products, and products used as ingredi- this chapter. Each process schedule ents of products, shall not bear or con- must be approved in writing by a proc- tain any pesticide chemical, food addi- ess authority for safety and efficacy in tives, or color additive residue in ex- meeting the performance standards es- cess of the level permitted under the tablished for the product in question. A Federal Food, Drug, and Cosmetic Act process authority must have access to and the regulations in this subchapter, the establishment in order to evaluate or any other substance that is prohib- and approve the safety and efficacy of ited by such regulations or that other- each process schedule. wise makes the products adulterated. (c) Under the auspices of a processing (c) Standards and procedures. Instruc- authority, an establishment must vali- tions specifying the standards and pro- date new or altered process schedules cedures for determining when ingredi- by scientifically supportable means, ents of finished products are in compli- such as information gleaned from the ance with this section shall be issued literature or by challenge studies con- to the inspectors by the Administrator. ducted outside the plant. Copies of such instructions will be made available to interested persons [64 FR 744, Jan. 6, 1999]

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§ 318.18 Handling of certain material (5) Protein fat free percentage, protein for mechanical processing. fat free content, PFF percentage, PFF Material to be processed into ‘‘Me- content or PFF of a product means the chanically Separated (Species)’’ shall meat protein (indigenous to the raw, be so processed within 1 hour from the unprocessed pork cut) content ex- time it is cut or separated from car- pressed as a percent of the non-fat por- casses or parts of carcasses, except tion of the finished product. that such product may be held for no (b) Normal Compliance Procedures. The more than 72 hours at 40 °F. (4 °C.) or Department shall collect samples of less, or held indefinitely at 0 °F. (¥18 cured pork products and analyze them °C.) or less. ‘‘Mechanically Separated for their PFF content. Analyses shall (Species)’’ shall, directly after being be conducted in accordance with the processed, be used as an ingredient in a ‘‘Official Methods of Analysis of the meat food product except that it may Association of Official Analytical be held prior to such use for no more Chemists §§ 950.46, and 928.08 (Chapter 1 than 72 hours at 40 °F. (4 °C.) or less or 39). The ‘‘Official Methods of Analysis indefinitely at 0 °F. (¥18 °C.) or less. of the Association of Official Analyt- ical Chemists,’’ 15th edition, 1990, is in- [43 FR 26423, June 20, 1978, as amended at 47 corporated by reference with the ap- FR 28256, June 29, 1982] proval of the Director of the Federal Register in accordance with 5 U.S.C. § 318.19 Compliance procedure for cured pork products. 552(a) and 1 CFR part 51. Each analytical result shall be recorded and evalu- (a) Definitions. For the purposes of ated to determine whether future sam- this section: pling of product Groups within an offi- (1) A product is that cured pork arti- cial establishment shall be periodic or cle which is contained within one daily under the provisions of paragraph Group as defined in paragraph (a)(2) of (b)(1) of this section, and if the affected this section and which purports to lot and subsequent production of like meet the criteria for a single product product shall be U.S. retained, or ad- designated under the heading ‘‘Product ministratively detained, as appro- Name and Qualifying Statements’’ in priate, as provided in paragraph (b)(2) the chart in § 319.104 or the chart in of this section. 2 § 319.105. (2) A Product Group or a Group means 1 one of the following: A copy of the ‘‘Official Methods of Anal- ysis of the Association of Official Analytical Group I, consisting of cured pork products Chemists,’’ 15th edition, 1990, is on file with which have been cooked while imperviously the Director, Office of the Federal Register, encased. Any product which fits into the and may be purchased from the Association Group will be placed in this Group regardless of Official Analytical Chemists, Inc., 2200 of any other considerations. Wilson Boulevard, Suite 400, Arlington, Vir- Group II, consisting of cured pork products ginia 22201. which have been water cooked. Any product 2 Rules for Rounding: which does not fit into Group I but does fit 1. Laboratory results for percent meat pro- into Group II will be placed into Group II re- tein and fat will be reported to the second gardless of any other considerations. decimal place (hundredths). Group III, consisting of boneless smoke- 2. PFF and Sample Values for charting house heated cured pork products. Any purposes will be calculated from the reported boneless product that does not fit into Group laboratory results to the second decimal I or Group II shall be placed in Group III. place. Rounding of calculations to reach two Group IV, consisting of bone-in or semi- decimal places will be done by the following boneless smokehouse heated cured pork rule: products. Any product that is not completely All values of five-thousandths (0.005) or boneless or still contains all the bone which more will be rounded up to the next highest is traditional for bone-in product, and does hundredth. All values of less than five-thou- not fit into Group I, Group II, or Group III sandths (0.005) will be dropped. shall be placed in this Group. 3. For compliance with the Absolute Min- imum PFF requirements, the PFF will be (3) A lot is that product from one pro- rounded to the first decimal place (tenths). duction shift. Rounding of calculations to reach one dec- (4) A production rate is frequency of imal place will be done by the following rule: production, expressed in days per week. Continued

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(1) Criteria to determine sampling fre- Value is greater than ¥1.40 (e.g., ¥1.39, quency of Product Groups. For each offi- ¥1.14, 0, 0.50, etc.) and shall be daily cial plant preparing cured pork prod- when the Group Value is ¥1.40 or less ucts, Product Groups shall be sampled (e.g., ¥1.40, ¥1.45, ¥1.50, etc.); pro- periodically or daily. Analytical re- vided, however, that once daily sam- sults shall be evaluated and the sampling has been initiated, it shall con- pling frequency determined as follows: tinue until the Group Value is 0.00 or (i) Determine the difference between greater, and each of the last seven the individual PFF analysis and the Sample Values is ¥1.65 or greater (e.g., applicable minimum PFF percentage ¥1.63, ¥1.50, etc.), and there is no requirement of § 319.104 or § 319.105. The other product within the affected resulting figure shall be negative when Group being U.S. retained as produced, the individual sample result is less under provisions of paragraph (b)(2) or than the applicable minimum PFF per- (c). centage requirement and shall be posi- (2) Criteria for U.S. retention or admin- tive when the individual sample result istrative detention of cured pork products is greater than the applicable min- for further analysis. Cured prok prod- imum PFF percentage requirement. ucts shall be U.S. retained, or adminis- (ii) Divide the resulting number by tratively detained, as appropriate, the standard deviation assigned to the when prescribed by paragraphs (b)(2) (i) Product Group represented by the sam- or (ii) of this section as follows: ple to find the Standardized Difference. (i) Absolute Minimum PFF Require- The standard deviation assigned to ment. In the event that an analysis of Groups I and II is 0.75 and to Groups III an individual sample indicates a PFF and IV is 0.91. (iii) Add 0.25 to the Standardized Dif- content below the applicable minimum ference to find the Adjusted Standard- requirement of § 319.104 or § 319.105 by ized Difference. 2.3 or more percentage points for a (iv) Use the lesser of 1.90 and the Ad- Group I or II product, or 2.7 or more justed Standardized Difference as the percentage points for a Group III or IV Sample Value. product, the lot from which the sample (v) Cumulatively total Sample Val- was collected shall be U.S. retained if ues to determine the Group Value. The in an official establishment and shall first Sample Value in a Group shall be be subject to administrative detention the Group Value, and each succeeding if not in an official establishment un- Group Value shall be determined by less returned to an official establish- adding the most recent Sample Value ment and there U.S. retained. Any sub- to the existing Group Value; provided, sequently produced lots of like product however, that in no event shall the and any lots of like product for which Group Value exceed 1.00. When calcula- production dates cannot be established tion of a Group Value results in a fig- shall be U.S. retained or subject to ad- ure greater than 1.00, the Group Value ministrative detention. Such adminis- shall be 1.00 and all previous Sample tratively detained product shall be Values shall be ignored in determining handled in accordance with part 329 of future Group Values. this subchapter, or shall be returned to (vi) The frequency of sampling of a an official establishment and subjected Group shall be periodic when the Group to the provisions of paragraph (c)(1) (i) or (ii) of this section, or shall be re- All PFF values of five-hundredths (0.05) or labeled in compliance with the applica- more will be rounded up to the next highest ble standard, under the supervision of a tenth. All PFF values of less than five-hun- program employee, at the expense of dredths (0.05) will be dropped. the product owner. Disposition of such 4. For product disposition (pass-fail of a U.S. retained product shall be in ac- minimum PFF standard for retained prod- cordance with paragraph (c) of this sec- uct) the average PFF calculation will be tion. rounded to the first decimal place. Indi- vidual PFF Values will be calculated to the (ii) Product Value requirement. The nearest hundredth as in (2) above. The aver- Department shall maintain, for each age, however, will be rounded to the nearest product prepared in an official estab- tenth as in (3) above. lishment, a Product Value. Except as

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provided in paragraph (c)(2) of this sec- graph (b)(2) of this section, the Depart- tion, calculation of the Product Value ment shall collect three randomly se- and its use to determine if a product lected samples from each such lot and shall be U.S. retained shall be as fol- analyze them individually for PFF con- lows: tent. The PFF content of the three (A) Determine the difference between samples shall be evaluated to deter- the individual PFF analysis and appli- mine disposition of the lot as provided cable minimum PFF percentage rein paragraph (c)(1) of this section and quirement of § 319.104 and § 319.105. The the action to be taken on subsequently resulting figure shall be negative when produced lots of like product as pro- the individual sample result is less vided in paragraph (c)(2) of this sec- than the applicable minimum PFF per- tion. 3 centage requirement and shall be posi- (1) A product lot which is U.S. re- tive when the individual sample result tained under the provisions of para- is greater than the applicable min- graph (b)(2) of this section may be re- imum PFF percentage requirement. leased for entry into commerce pro- (B) Divide the difference determined vided one of the following conditions is in paragraph (b)(2)(ii)(A) of this section met: by the standard deviation assigned to (i) The average PFF content of the the product’s Group in paragraph three samples randomly selected from (b)(1)(ii) of this section to find the the lot is equal to or greater than the standardized difference. applicable minimum PFF percentage (C) Use the lesser of 1.65 and the required by § 319.104 or § 319.105. Further standardized difference as the Sample processing to remove moisture for the Value. purpose of meeting this provision is (D) Cumulatively total Sample Val- permissible. In lieu of further analysis ues to determine the Product Value. to determine the effects of such proc- The first Sample Value of a product essing, each 0.37 percent weight reduc- shall be the Product Value, and each tion due to moisture loss resulting succeeding Product Value shall be de- from the processing may be considered termined by adding the most recent the equivalent of a 0.1 percent PFF Sample Value to the existing Product gain. Value; provided, however, that in no (ii) The lot of the product is relabeled event shall the Product Value exceed to conform to the provisions of § 319.104 1.15. When calculation of a Product or § 319.105, under the supervision of a Value results in a figure greater than program employee. 1.15, the Product Value shall be 1.15, and all previous Sample Values shall be (iii) The lot is one that has been pre- ignored in determining future Product pared subsequent to preparation of the Values. lot which, under the provisions of para- (E) Provided daily group sampling is graph (c)(2) of this section, resulted in in effect pursuant to the provisions of discontinuance of U.S. retention of new paragraph (b)(1) of this section, and lots of like product. Such lot may be provided further the Product Value is released for entry into commerce prior ¥1.65 or less (e.g., ¥1.66), the affected to receipt of analytical results for lot (if within the official establish- which sampling has been conducted. ment) and all subsequent lots of like Upon receipt of such results, they shall product prepared by and still within be subjected to the provisions of para- the official establishment shall be U.S. graphs (b)(2)(i) and (c)(2) of this sec- retained and further evaluated under tion. paragraph (c) of this section. Except for release of individual lot pursuant to 3 If the processor does not wish to have the paragraph (c)(1), subsequently produced product evaluated in this manner, alternate lots of like product shall continue to be sampling plans may be used provided such U.S. retained until discontinued pursu- plans have been formulated by the processor and approved by the Administrator prior to ant to paragraph (c)(2) of this section. evaluation by the three-sample criteria, and (c) Compliance procedure during prod- provided the analyses specified in such plans uct retention. When a product lot is U.S. are performed at the expense of the proc- retained under the provisions of para- essor.

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(2) The PFF content of three ran- Value shall revert to the provisions of domly selected samples from each U.S. paragraph (b)(2)(ii) of this section. retained lot shall be used to maintain (3) For purposes of this section, the the Product Value described in para- plant owner or operator shall have the graph (c)(2)(ii). The manner and effect option of temporarily removing a prod- of such maintenance shall be as fol- uct from its Product Group, provided lows: (i) Find the average PFF content product lots are being U.S. retained, as of the three samples. produced, and provided further that the (ii) Determine the difference between average production rate of the product, that average and the applicable min- over the 8-week period preceding the imum PFF percentage requirement of week in which the first U.S. retained § 319.104 or § 319.105. The resulting figure lot was prepared, is not greater than 20 shall be negative when the average of percent of the production rate of its the sample results is less than the ap- Group. When a product is thus removed plicable minimum PFF percentage re- from its Group, analytical results of quirement and shall be positive when product samples shall not cause daily the average of the sample results is sampling of the Group. When pursuant greater than the applicable minimum to paragraph (c)(2)(vi) of this section, PFF requirements. new lots of the product are no longer (iii) Divide the resulting figure by being U.S. retained, the product shall the standard deviation assigned to the again be considered with its Group. product’s Group in paragraph (b)(1)(ii) (d) Adulterated and misbranded prod- of this section, to find the standardized ucts. Products not meeting specified difference. PFF requirements, determined accord- (iv) Use the lesser of 1.30 and the ing to procedures set forth in this sec- standardized difference as the Sample tion, may be deemed adulterated under Value. section 1(m)(8) of the Act (21 U.S.C. (v) Add the first Sample Value thus 601(m)(8)) and misbranded under sec- calculated to the latest Product Value tion 1(n) of the Act (21 U.S.C. 601(n)). calculated under the provisions of (e) Quality control. Cured pork prod- paragraph (c)(2)(ii) of this section to ucts bearing on their labeling the find the new Product Value. To find statement ‘‘X% of Weight is Added In- each succeeding Product Value, add the gredients’’ shall be prepared only under most recent Sample Value to the exist- a quality control system or program in ing Product Value; provided, however, accordance with § 318.4 of this sub- that in no event shall the Product chapter. With respect to any other Value exceed 1.15. When the addition of cured pork product, official establish- a Sample Value to an existing Product ments may institute quality control Value results in a figure greater than procedures under § 318.4 of this sub- 1.15, the Product Value shall be 1.15 and chapter. Cured pork products produced all previous Sample Values shall be ig- in such establishments may be exempt nored in determining future Product from the requirements of this section, Values. provided in plant quality control proce- (vi) New lots of like product shall dures are shown to attain the same or continue to be retained pending dis- higher degree of compliance as the pro- position in accordance with paragraph cedures set forth in this section; pro- (c)(1) of this section until, after 5 days vided, however, that all cured pork of production, the Product Value is 0.00 products produced shall be subject to or greater, and the PFF content of no the applicable Absolute Minimum PFF individual sample from a U.S. retained content requirement, regardless of any lot is less than the Absolute Minimum quality control procedures in effect. PFF requirement specified in para- [49 FR 14877, Apr. 13, 1984; 49 FR 33434, Aug. graph (b)(2)(i) of this section. Should 23, 1984, as amended at 59 FR 33642, June 30, an individual sample fail to meet its 1994; 60 FR 10304, Feb. 24, 1995; 62 FR 45025, Absolute Minimum PFF requirement, Aug. 25, 1997] the 5-day count shall begin anew. (vii) When U.S. retention of new lots § 318.20 Use of animal drugs. is discontinued under the above provi- Animal drug residues are permitted sions, maintenance of the Product in meat and meat food products if such

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residues are from drugs which have (6) Calculating the percentage of in- been approved by the Food and Drug digenous water in the cooked sausage Administration and any such drug resi- by multiplying the percentage of pro- dues are within tolerance levels ap- tein determined in (b)(5) by 4, (This proved by the Food and Drug Adminis- amount is the percentage of water at- tration, unless otherwise determined tributable to Group 1 protein-contrib- by the Administrator and listed herein. uting ingredients and one percent of Group 2 protein-contributing ingredi- [50 FR 32165, Aug. 9, 1985] ents in a cooked sausage.); and § 318.21 [Reserved] (7) Subtracting the percentage of water calculated in (b)(6) from the § 318.22 Determination of added water total percentage of water determined in cooked sausages. in (b)(1). (This amount is the percentage of added water in a cooked sau- (a) For purposes of this section, the 1 following definitions apply. sage.) (1) Cooked sausage. Cooked sausage is [55 FR 7299, Mar. 1, 1990] any product described in § 319.140 and §§ 319.180–319.182 of this chapter. § 318.23 Heat-processing and stabiliza- (2) Group 1 Protein-Contributing Ingre- tion requirements for uncured meat dients. Ingredients of livestock or poul- patties. try origin from muscle tissue which is (a) Definitions. For purposes of this skeletal or which is found in the edible section, the following definitions shall organs, with or without the accom- apply: panying and overlying fat, and the por- (1) Patty. A shaped and formed, tions of bone, skin, sinew, nerve, and comminuted, flattened cake of meat blood vessels which normally accom- food product. pany the muscle tissue and which are (2) Comminuted. A processing term de- not separated from it in the process of scribing the reduction in size of pieces dressing; meat byproducts; mechani- of meat, including chopping, flaking, cally separated (species); and poultry grinding, or mincing, but not including products; except those ingredients chunking or sectioning. processed by hydrolysis, extraction, (3) Partially-cooked patties. Meat pat- concentrating or drying. ties that have been heat processed for (3) Group 2 Protein-Contributing Ingre- less time or using lower internal tem- dients. Ingredients from Gorup 1 pro- peratures than are prescribed by para- tein-contributing ingredients processed graph (b)(1) of this section. by hydrolysis, extraction, concen- (4) Char-marked patties. Meat patties trating, or drying, or any other ingre- that have been marked by a heat dient which contributes protein. source and that have been heat proc- (b) The amount of added water in essed for less time or using lower inter- cooked sausage is calculated by: nal temperatures than are prescribed (1) Determining by laboratory anal- by paragraph (b)(1) of this section. ysis the total percentage of water con- (b) Heat-processing procedures for fully- tained in the cooked sausage; and cooked patties. (1) Official establish- (2) Determining by laboratory anal- ments which manufacture fully-cooked ysis the total percentage of protein patties shall use one of the following contained in the cooked sausage; and heat-processing procedures: (3) Calculating the percentage of protein in the cooked sausage contributed 1 The equation for the narrative description by the Group 2 protein-contributing in- of the calculation for added water is as fol- gredients; and lows: AW=TW-(TP-(P-1.0))4, Where (4) Subtracting one pecent from the AW=Added Water, TW-Total Water Deter- total percentage of protein calculated mined by Laboratory Analysis, TP=Total in (b)(3)); and Protein Determined by Laboratory Analysis, P=Protein Contributed by Group 2 Protein- (5) Subtracting the remaining per- Contributing Ingredients, 1.0=Percent Allow- centage of protein calculated in (b)(3) ance for Group 2 Protein-Contributing Ingre- from the total protein content deter- dients, 4=Moisture-Protein Ratio for Cooked mined in (b)(2); and Sausage.

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PERMITTED HEAT-PROCESSING TEMPERATURE/ tridium botulinum, and no more than a 1 TIME COMBINATIONS FOR FULLY-COOKED PAT- log10 multiplication of Clostridium TIES perfringens, within the product. (2) For each meat patty product pro- Minimum internal temperature at the Minimum holding center of each patty time after required duced using a stabilization process (Degrees) internal temperature other than one conducted in accord- is reached (Time) ance with the Hazard Analysis and Fahrenheit Or centigrade Or sec- Critical Control Point (HACCP) system Minutes onds requirements in part 417 of this chapter, an establishment must develop and 151 ...... 66.1 ...... 68 41 152 ...... 66.7 ...... 54 32 have on file, available to FSIS, a proc- 153 ...... 67.2 ...... 43 26 ess schedule, as defined in § 301.2 of this 154 ...... 67.8 ...... 34 20 chapter. Each process schedule must be 155 ...... 68.3 ...... 27 16 156 ...... 68.9 ...... 22 13 approved in writing by a process au- 157 (and up) ...... 69.4 (and up) ...... 17 10 thority for safety and efficacy in meeting the performance standards estab- (2) The official establishment shall lished for the product in question. A measure the holding time and tempera- process authority must have access to ture of at least one fully-cooked patty an establishment in order to evaluate from each production line each hour of and approve the safety and efficacy of production to assure control of the each process schedule. heat process. The temperature measuring device shall be accurate within 1 (3) Under the auspices of a processing degree F. authority, an establishment must vali- (3) Requirements for handling heat- date new or altered process schedules ing deviations. (i) If for any reason a by scientifically supportable means, heating deviation has occurred, the of- such as information gleaned from the ficial establishment shall investigate literature or by challenge studies con- and identify the cause; take steps to ducted outside the plant. assure that the deviation will not (4) Partially cooked patties must recur; and place on file in the official bear the labeling statement ‘‘Partially establishment, available to any duly cooked: For Safety Cook Until Well authorized FSIS program employee, a Done (Internal Meat Temperature 160 report of the investigation, the cause degrees F.).’’ The labeling statement of the deviation, and the steps taken to must be adjacent to the product name, prevent recurrence. and prominently placed with such con- (ii) In addition, in the case of a heat- spicuousness (as compared with other ing deviation, the official establish- words, statements, designs or devices ment may reprocess the affected prod- in the labeling) as to render it likely to uct, using one of the methods in para- be read and understood by the ordinary graph (b)(1) in this section; use the af- individual under customary conditions fected product as an ingredient in an- of purchase and use. other product processed to one of the (5) Char-marked patties must bear temperature and time combinations in the labeling statement ‘‘Uncooked, paragraph (b)(1) in this section, pro- Char-marked: For Safety, Cook Until vided this does not violate the final Well Done (Internal Meat Temperature product’s standard of composition, 160 degrees F.).’’ The labeling state- upset the order of predominance of in- ment shall be adjacent to the product gredients, or perceptibly affect the nor- name, at least one-half the size of the mal product characteristics; or relabel largest letter in the product name, and the affected product as a partially- prominently placed with such con- cooked patty product, if it meets the spicuousness (as compared with other stabilization requirements in para- words, statements, designs or devices graph (c) of this section. in the labeling) as to render it likely to (c) Stabilization. (1) Fully cooked, par- be read and understood by the ordinary tially cooked, and char-marked meat individual under customary conditions patties must be produced using proc- of purchase and use. esses ensuring no multiplication of toxigenic microorganisms such as Clos- [64 FR 744, Jan. 6, 1999]

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§ 318.24 Product prepared using ad- marrow, spinal cord, and DRG as pre- vanced meat/bone separation ma- scribed in paragraph (c)(1) of this sec- chinery; process control. tion; the use of the product and spent (a) General. Meat, as defined in § 301.2 bone materials exiting the AMR sys- of this subchapter, may be derived by tem; and the frequency with which mechanically separating skeletal mus- these activities will be performed. cle tissue from the bones of livestock, (3) The establishment shall maintain other than skulls or vertebral column records on a daily basis sufficient to bones of cattle 30 months of age and document the implementation and older as provided in § 310.22 of this sub- verification of its production process. chapter, using advances in mechanical (4) The establishment shall make meat/bone separation machinery (i.e., available to inspection program per- AMR systems) that, in accordance with sonnel the documentation described in this section, recover meat— paragraphs (b)(2) and (b)(3) of this sec- (1) Without significant incorporation tion and any other data generated of bone solids or bone marrow as meas- using these procedures. ured by the presence of calcium and (c) Noncomplying product. (1) Notwith- iron in excess of the requirements in standing any other provision of this this section, and section, product that is recovered using (2) Without the presence of any brain, advanced meat/bone separation ma- trigeminal ganglia, spinal cord, or dor- chinery is not meat under any one or sal root ganglia (DRG). more of the following circumstances: (b) Process control. As a prerequisite (i) Bone solids. The product’s calcium to labeling or using product as meat content, measured by individual sam- derived by the mechanical separation ples and rounded to the nearest 10th, is of skeletal muscle tissue from live- more than 130.0 mg per 100 g. stock bones, the operator of an estab- (ii) Bone marrow. The product’s added lishment must develop, implement, and iron content, measured by duplicate maintain procedures that ensure that analyses on individual samples and the establishment’s production process rounded to the nearest 10th, is more is in control. than 3.5 mg per 100 g. 1 (1) The production process is not in control if the skulls entering the AMR 1 The excessive iron (ExcFe) measurement system contain any brain or trigeminal for an analyzed sample is equal to the ob- ganglia tissue, if the vertebral column tained iron (Fe) result expressed in mg/100 g bones entering the AMR system con- measured and rounded to the nearest 100th or tain any spinal cord, if the recovered more for that sample, minus the product of product fails otherwise under any pro- three factors: (1) The iron to protein ratio vision of paragraph (c)(1), if the prod- (IPR) factor associated with corresponding hand-deboned product; (2) the obtained pro- uct is not properly labeled under the tein (P) result (%) for that sample; and (3) a provisions of paragraph (c)(2), or if the constant factor of 1.10. In formula, this can spent bone materials are not properly be written as: ExcFe = mFe ¥ IPR × Protein handled under the provisions of para- × 1.10, where ExcFe represents the excess graph (c)(3) of this section. iron, expressed in units of mg/100 g; mFe rep- (2) The establishment must document resents the measured level of iron (Fe, mg/ its production process controls in writ- 100 g), IPR is the iron to protein ratio for the ing. The program must be designed to appropriate hand-deboned product, and ‘‘Protein’’ is the measured level of protein ensure the on-going effectiveness of the rounded to the nearest 100th and expressed as process controls. If the establishment a percentage of the total weight of the sam- processes cattle, the program must be ple. In lieu of data demonstrating otherwise, in its HACCP plan, its Sanitation SOP, the values of IPR to be used in the above for- or other prerequisite program. The pro- mula are as follows: For beef products the gram shall describe the on-going value of IPR is equal to 0.104, except for any verification activities that will be per- combination of bones that include any beef formed, including the observation of neckbone product, for which the value of 0.138 is to be used; for pork product, the IPR the bones entering the AMR system for value is 0.052. Other IPR values can be used brain, trigeminal ganglia, and spinal provided that the operator of an establish- cord; the testing of the product exiting ment has verified and documented the ratio the AMR system for bone solids, bone Continued

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(iii) Brain or trigeminal ganglia. Skulls § 318.300 Definitions. that enter the AMR system have tis- (a) Abnormal container. A container sues of brain or trigeminal ganglia. with any sign of swelling or product (iv) Spinal cord. Vertebral column bones that enter the AMR system have leakage or any evidence that the con- tissues of spinal cord, or the product tents of the unopened container may be that exits the AMR system contains spoiled. spinal cord. (b) Acidified low acid product. A (v) DRG. The product that exits the canned product which has been formu- AMR system contains DRG. lated or treated so that every compo- (2) If product that may not be labeled nent of the finished product has a pH of or used as ‘‘meat’’ under this section 4.6 or lower within 24 hours after the meets the requirements of § 319.5 of this completion of the thermal process un- subchapter, it may bear the name less data are available from the estab- ‘‘Mechanically Separated (Species)’’ lishment’s processing authority dem- except as follows: onstrating that a longer time period is (i) If skulls or vertebral column safe. bones of cattle younger than 30 months (c) Bleeders. Small orifices on a retort of age that enter the AMR system have through which steam, other gasses, and tissues of brain, trigeminal ganglia, or condensate are emitted from the retort spinal cord, the product that exits the throughout the entire thermal process. AMR system shall not be used as an in- (d) Canned product. A meat food prod- gredient of a meat food product. uct with a water activity above 0.85 (ii) If product that exits the AMR which receives a thermal process either system contains spinal cord or DRG before or after being packed in a her- from bones of cattle younger than 30 metically sealed container. Unless oth- months of age, it shall not be used as erwise specified, the term ‘‘product’’ as an ingredient of a meat food product. used in this subpart G shall mean (iii) If product derived from any ‘‘canned product.’’ bones of cattle of any age does not (e) Closure technician. The indi- comply with (c)(1)(i) or (ii), it may bear vidual(s) identified by the establish- a common or usual name that is not ment as being trained to perform spe- false or misleading, except that the cific container integrity examinations product may not bear the name ‘‘Me- as required by this subpart and des- chanically Separated (Beef).’’ ignated by the establishment to per- (3) Spent skulls or vertebral column form such examinations. bone materials from cattle younger (f) Code lot. All production of a par- than 30 months of age that exit the ticular product in a specific size con- AMR system shall not be used as an in- tainer marked with a specific con- gredient of a meat food product. tainer code. [69 FR 1884, Jan. 12, 2004] (g) Come-up time. The elapsed time, including venting time (if applicable), between the introduction of the heat- Subparts B–F [Reserved] ing medium into a closed retort and the start of process timing. Subpart G—Canning and Canned (h) Critical factor. Any characteristic, Products condition or aspect of a product, container, or procedure that affects the SOURCE: 51 FR 45619, Dec. 19, 1986, unless adequacy of the process schedule. Crit- otherwise noted. ical factors are established by processing authorities. of iron content to protein content in the (i) Headspace. That portion of a con- skeletal muscle tissue attached to bones tainer not occupied by the product. prior to their entering the AMR system, (1) Gross headspace. The vertical dis- based on analyses of hand-deboned samples, tance between the level of the product and the documented value is to be substituted for the IPR value (as applicable) in (generally the liquid surface) in an up- the above formula with respect to product right rigid container and the top edge that the establishment mechanically sepa- of the container (i.e., the flange of an rates from those bones. unsealed can, the top of the double

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seam on a sealed can, or the top edge of (q) Processing authority. The person(s) an unsealed jar). or organization(s) having expert knowl- (2) Net headspace. The vertical dis- edge of thermal processing require- tance between the level of the product ments for foods in hermetically sealed (generally the liquid surface) in an up- containers, having access to facilities right rigid container and the inside for making such determinations, and surface of the lid. designated by the establishment to per- (j) Hermetically sealed containers. Air- form certain functions as indicated in tight containers which are designed this subpart. and intended to protect the contents (r) Program employee. Any inspector against the entry of microorganisms or other individual employed by the during and after thermal processing. Department or any cooperating agency (1) Rigid container. A container, the who is authorized by the Secretary to shape or contour of which, when filled do any work or perform any duty in and sealed, is neither affected by the connection with the Program (see enclosed product nor deformed by ex- § 301.2(f)). ternal mechanical pressure of up to 10 (s) Retort. A pressure vessel designed pounds per square inch gauge (0.7 kg/ for thermal processing of product cm2) (i.e., normal firm finger pressure). packed in hermetically sealed con- (2) Semirigid container. A container, tainers. the shape or contour of which, when (t) Seals. Those parts of a semirigid filled and sealed, is not significantly container and lid or of a flexible con- affected by the enclosed product under tainer that are fused together in order normal atmospheric temperature and to hermetically close the container. pressure, but can be deformed by exter- (u) Shelf stability. The condition nal mechanical pressure of less than 10 achieved by application of heat, suffi- pounds per square inch gauge (0.7 kg/ cient, alone or in combination with cm2) (i.e., normal firm finger pressure). other ingredients and/or treatments, to (3) Flexible container. A container, the render the product free of microorga- shape or contour of which, when filled nisms capable of growing in the prod- and sealed, is significantly affected by uct at nonrefrigerated conditions (over the enclosed product. 50 °F or 10 °C) at which the product is (k) Incubation tests. Tests in which intended to be held during distribution the thermally processed product is and storage. Shelf stability and shelf kept at a specific temperature for a stable are synonymous with commer- specified period of time in order to de- cial sterility and commercially sterile, termine if outgrowth of microorga- respectively. nisms occurs. (v) Thermal process. The heat treat- (l) Initial temperature. The tempera- ment necessary to achieve shelf sta- ture, determined at the initiation of a bility as determined by the establish- thermal process cycle, of the contents ment’s processing authority. It is of the coldest container to be proc- quantified in terms of: essed. (1) Time(s) and temperature(s); or (m) Low acid product. A canned prod- (2) Minimum product temperature. uct in which any component has a pH (w) Venting. The removal of air from value above 4.6. a retort before the start of process tim- (n) Process schedule. The thermal ing. process and any specified critical fac- (x) Water activity. The ratio of the tors for a given canned product re- water vapor pressure of the product to quired to achieve shelf stability. the vapor pressure of pure water at the (o) Process temperature. The minimum same temperature. temperature(s) of the heating medium to be maintained as specified in the § 318.301 Containers and closures. process schedule. (a) Examination and cleaning of empty (p) Process time. The intended time(s) containers. (1) Empty containers, clo- a container is to be exposed to the sures, and flexible pouch roll stock heating medium while the heating me- shall be evaluated by the establish- dium is at or above the process tem- ment to ensure that they are clean and perature(s). free of structural defects and damage

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that may affect product or container closure. These examinations should be integrity. Such an examination should made at intervals of not more than 4 be based upon a statistical sampling hours of continuous closing machine plan. operation. At least one container from (2) All empty containers, closures, each closing head shall be examined on and flexible pouch roll stock shall be the packer’s end during each regular stored, handled, and conveyed in such a examination period. Examination re- manner that will prevent soiling and sults along with any necessary correc- damage that could affect the hermetic tive actions, such as adjusting or re- condition of the sealed container. pairing the closing machine, shall be (3) Just before filling, rigid con- promptly recorded by the closure tech- tainers shall be cleaned to prevent in- nician. The establishment shall have corporation of foreign matter into the container specification guidelines for finished product. Closures, semirigid double seam integrity on file and avail- containers, preformed flexible pouches, able for review by Program employees. and flexible pouch roll stock contained A teardown examination of the can in original wrappings do not need to be maker’s end shall be performed on at cleaned before use. least one container selected from each (b) Closure examinations for rigid con- closing machine during each examina- tainers (cans)—(1) Visual examinations. A tion period except when teardown ex- closure technician shall visually exam- aminations are made on incoming ine the double seams formed by each empty containers or when, in the case closing machine head. When seam de- of self-manufactured containers, the fects (e.g., cutovers, sharpness, containers are made in the vicinity of knocked down flanges, false seams, the establishment and the container droops) are observed, necessary correc- plant records are made available to tive actions, such as adjusting or re- Program employees. Additional tear- pairing the closing machine, shall be down examinations on the packer’s end taken. In addition to the double seams, should be made at the beginning of pro- the entire container shall be examined duction, immediately following every for product leakage or obvious defects. jam in a closing machine and after A visual examination shall be per- closing machine adjustment (including formed on at least one container from adjustment for a change in container each closing machine head, and the ob- size). The following procedures shall be servations, along with any corrective used in teardown examinations of dou- actions, shall be recorded. Visual ex- ble seams: aminations shall be conducted with (i) One of the following two methods sufficient frequency to ensure proper shall be employed for dimensional closure and should be conducted at measurements of the double seam. least every 30 minutes of continuous (a) Micrometer measurement. For cylin- closing machine operation. Additional drical containers, measure the fol- visual examinations shall be made by lowing dimensions (Figure 1) at three the closure technician at the beginning points approximately 120 degrees apart of production, immediately following on the double seam excluding and at every jam in the closing machine and least one-half inch from the side seam after closing machine adjustment (in- juncture: cluding adjustment for changes in con- (1) Double seam length—W; tainer size). (2) Double seam thickness—S; (2) Teardown examinations. Teardown (3) Body hook length—BH; and examinations of double seams formed (4) Cover hook length—CH. by each closing machine head shall be Maximum and minimum values for performed by a closure technician at a each dimensional measurement shall frequency sufficient to ensure proper be recorded by the closure technician.

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(b) Seamscope or seam projector. Re- imum, the seam(s) examined shall be quired measurements of the seam in- stripped to assess the degree of wrin- clude thickness, body hook, and over- kling. lap. Seam thickness shall be obtained (iii) Side seam juncture rating. Regard- by micrometer. For cylindrical con- less of the dimensional measurement tainers, at least two locations, exclud- method used to measure seam dimen- ing the side seam juncture, shall be sions, the cover hook shall be stripped used to obtain the required measure- to examine the cover hook droop at the ments. juncture for containers having side (ii) Seam tightness. Regardless of the seams. dimensional measurement method used (iv) Examination of noncylindrical con- to measure seam dimensions, at a min- tainers. Examination of noncylindrical

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containers (e.g., square, rectangular, after closing machine adjustment (in- ‘‘D’’-shaped, and irregularly-shaped) cluding adjustment for a change in shall be conducted as described in para- container size). graphs (b)(2) (i), (ii), and (iii) of this (d) Closure examinations for semirigid section except that the required dimen- and flexible containers—(1) Heat seals— sional measurements shall be made on (i) Visual examinations. A closure tech- the double seam at the points listed in nician shall visually examine the seals the establishment’s container speci- formed by each sealing machine. When fication guidelines. sealing defects are observed, necessary (c) Closure examinations for glass con- corrective actions, such as adjusting or tainers—(1) Visual examinations. A clo- repairing the sealing machine, shall be sure technician shall visually assess taken and recorded. In addition to ex- the adequacy of the closures formed by amining the heat seals, the entire con- each closing machine. When closure de- tainer shall be examined for product fects, such as loose or cocked caps, leakage or obvious defects. Visual ex- fractured or cracked containers and aminations shall be performed before low vacuum jars, are observed, nec- and after the thermal processing oper- essary corrective actions, such as ad- ation and with sufficient frequency to justing or repairing the closing ma- ensure proper closure. These examina- chine shall be taken and recorded. In tions should be conducted at least in addition to the closures, the entire accordance with a statistical sampling container shall be examined for de- plan. All defects noted and corrective fects. Visual examinations shall be actions taken shall be promptly re- made with sufficient frequency to en- corded. sure proper closure and should be con- (ii) Physical tests. Tests determined ducted at least every 30 minutes of con- by the establishment as necessary to tinuous closing machine operation. Ad- assess container integrity shall be conditional visual examinations shall be ducted by the closure technician at a made by the closure technician and the frequency sufficient to ensure proper observations recorded at the beginning closure. These tests shall be performed of production, immediately following after the thermal processing operation every jam in the closing machine, and and should be made at least every 2 after closing machine adjustment (in- hours of continuous production. The cluding adjustment for a change in establishment’s acceptance guidelines container size). for each test procedure shall be on file (2) Closure examinations and tests. De- and available for review by Program pending upon the container and clo- employees. Test results along with any sure, tests shall be performed by a clo- necessary corrective actions, such as sure technician at a frequency suffi- adjusting or repairing the sealing ma- cient to ensure proper closure. These chine, shall be recorded. examinations should be made either (2) Double seams on semirigid or before or after thermal processing and flexible containers shall be examined at intervals of not more than 4 hours of and the results recorded as provided in continuous closing machine operation. paragraph (b) of this section. Any addi- At least one container from each clos- tional measurements specified by the ing machine shall be examined during container manufacturer shall also be each regular examination period. Ex- made and recorded. amination results along with any nec- (e) Container coding. Each container essary corrective actions, such as ad- shall be marked with a permanent, leg- justing or repairing the closing ma- ible, identifying code mark. The mark chine, shall be promptly recorded by shall, at a minimum, identify in code the closure technician. The establish- the product (unless the product name ment shall have specification guide- lithographed or printed elsewhere on lines for closure integrity on file and the container) and the day and year available for review by Program em- the product was packed. ployees. Additional closure examina- (f) Handling of containers after closure. tions should be made at the beginning (1) Containers and closures shall be of production, immediately following protected from damage which may every jam in the closing machine, and cause defects that are likely to affect

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the hermetic condition of the con- the retort come-up operating proce- tainers. The accumulation of sta- dures and critical factors. tionary containers on moving con- (2) Letters or other written commu- veyors should be minimized to avoid nications from a processing authority damage to the containers. recommending all process schedules (2) The maximum time lapse between shall be maintained on file by the es- closing and initiation of thermal proc- tablishment. Upon request by Program essing shall be 2 hours. However, the employees, the establishment shall Administrator may specify a shorter make available such letters or written period of time when considered nec- communications (or copies thereof). If essary to ensure product safety and critical factors are identified in the stability. A longer period of time be- process schedule, the establishment tween closing and the initiation of shall provide the inspector with a copy thermal processing may be permitted of the procedures for measuring, con- by the Administrator. trolling, and recording these factors, along with the frequency of such meas- (Approved by the Office of Management and urements, to ensure that the critical Budget under control number 0583–0015) factors remain within the limits used § 318.302 Thermal processing. to establish the process schedule. Once submitted, the process schedules and (a) Process schedules. Prior to the associated critical factors and the pro- processing of canned product for dis- cedures for measuring (including the tribution in commerce, an establish- frequency), controlling, and recording ment shall have a process schedule (as of critical factors shall not be changed defined in § 318.300(n) of this subpart) without the prior written submittal of for each canned meat product to be the revised procedures (including sup- packed by the establishment. porting documentation) to the inspec- (b) Source of process schedules. (1) tor at the establishment. Process schedules used by an establishment shall be developed or determined (Approved by the Office of Management and by a processing authority. Budget under control number 0583–0015) (2) Any change in product formula- § 318.303 Critical factors and the appli- tion, ingredients, or treatments that cation of the process schedule. are not already incorporated in a process schedule and that may adversely af- Critical factors specified in the proc- fect either the product heat penetra- ess schedule shall be measured, con- tion profile or sterilization value re- trolled and recorded by the establish- quirements shall be evaluated by the ment to ensure that these factors re- establishment’s processing authority. main within the limits used to estab- If it is determined that any such lish the process schedule. Examples of change adversely affects the adequacy factors that are often critical to proc- of the process schedule, the processing ess schedule adequacy may include: authority shall amend the process (a) General. (1) Maximum fill-in schedule accordingly. weight or drained weight; (3) Complete records concerning all (2) Arrangement of pieces in the con- aspects of the development or deter- tainer; mination of a process schedule, includ- (3) Container orientation during ther- ing any associated incubation tests, mal processing; shall be made available by the estab- (4) Product formulation; lishment to the Program employee (5) Particle size; upon request. (6) Maximum thickness for flexible, (c) Submittal of process information. (1) and to some extent semirigid con- Prior to the processing of canned prod- tainers during thermal processing; uct for distribution in commerce, the (7) Maximum pH; establishment shall provide the inspec- (8) Percent salt; tor at the establishment with a list of (9) Ingoing (or formulated) nitrite the process schedules (including alter- level (ppm); nate schedules) along with any addi- (10) Maximum water activity; and tional applicable information, such as (11) Product consistency or viscosity.

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(b) Continuous rotary and batch agi- tial temperature specified in the proc- tating retorts. (1) Minimum headspace; ess schedule. and (d) Timing devices. Devices used to (2) Retort reel speed. time applicable thermal processing op- (c) Hydrostatic retorts. (1) Chain or eration functions or events, such as conveyor speed. process schedule time, come-up time (d) Steam/air retorts. (1) Steam/air and retort venting, shall be accurate to ratio; and assure that all such functions or events (2) Heating medium flow rate. are achieved. Pocket watches and wrist watches are not considered acceptable § 318.304 Operations in the thermal timing devices. Analog and digital processing area. clocks are considered acceptable. If (a) Posting of processes. Process sched- such clocks do not display seconds, all ules (or operating process schedules) required timed functions or events for daily production, including min- shall have at least a 1-minute safety imum initial temperatures and oper- factor over the specified thermal proc- ating procedures for thermal processing operation times. Temperature/ essing equipment, shall be posted in a time recording devices shall correspond conspicuous place near the thermal within 15 minutes to the time of the processing equipment. Alternatively, day recorded on written records re- such information shall be available to quired by § 318.306. the thermal processing system oper- (e) Measurement of pH. Unless other ator and the inspector. methods are approved by the Adminis- (b) Process indicators and retort traffic trator, potentiometric methods using control. A system for product traffic electronic instruments (pH meters) control shall be established to prevent shall be used for making pH determina- product from bypassing the thermal tions when a maximum pH value is processing operation. Each basket, specified as a critical factor in a proc- crate or similar vehicle containing un- ess schedule. processed product, or at least one visible container in each vehicle, shall be (Approved by Office of Management and plainly and conspicuously marked with Budget under control number 0583–0015) a heat sensitive indicator that will visually indicate whether such unit has § 318.305 Equipment and procedures for heat processing systems. been thermally processed. Exposed heat sensitive indicators attached to (a) Instruments and controls common to container vehicles shall be removed be- different thermal processing systems—(1) fore such vehicles are refilled with un- Indicating temperature devices. Each reprocessed product. Container loading tort shall be equipped with at least one systems for crateless retorts shall be indicating temperature device that designed to prevent unprocessed prod- measures the actual temperature with- uct from bypassing the thermal proc- in the retort. The indicating tempera- essing operation. ture device, not the temperature/time (c) Initial temperature. The initial recording device, shall be used as the temperature of the contents of the reference instrument for indicating the coldest container to be processed shall process temperature. be determined and recorded by the es- (i) Mercury-in-glass thermometers. A tablishment at the time the processing mercury-in-glass thermometer shall cycle begins to assure that the tem- have divisions that are readable to 1F perature of the contents of every con- °(or 0.5C°) and whose scale contains not tainer to be processed is not lower than more than 17F°/inch (or 4.0C°/cm) of the minimum initial temperature spec- graduated scale. Each mercury-in-glass ified in the process schedule. Thermal thermometer shall be tested for accu- processing systems which subject the racy against a known accurate stand- filled and sealed containers to water at ard upon installation and at least once any time before process timing begins a year to ensure its accuracy. Records shall be operated to assure that such that specify the date, standard used, water will not lower the temperature test method, and the person or testing of the product below the minimum ini- authority performing the test shall be

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maintained on file by the establish- time and process temperature have ment and made available to Program been met. The frequency of recording employees. A mercury-in-glass ther- should not exceed 1-minute intervals. mometer that has a divided mercury (ii) Other devices. Temperature/time column or that cannot be adjusted to recording devices or procedures used in the standard shall be repaired and test- lieu of chart-type devices must meet ed for accuracy before further use, or known accurate standards for such de- replaced. vices or procedures when tested for ac- (ii) Other devices. Temperature-indi- curacy. Such a device must be accurate cating devices, such as resistance tem- enough for ensuring that process time perature detectors, used in lieu of mer- and temperature parameters have been cury-in-glass thermometers, shall meet met. known, accurate standards for such de- (3) Steam controllers. Each retort shall vices when tested for accuracy. The be equipped with an automatic steam records of such testing shall be avail- controller to maintain the retort tem- able to FSIS program employees. perature. This may be a recording/con- (2) Temperature/time recording devices. trolling instrument when combined Each thermal processing system shall with a temperature/time recording de- be equipped with at least one tempera- vice. ture/time recording device to provide a (4) Air valves. All air lines connected permanent record of temperatures to retorts designed for pressure proc- within the thermal processing system. essing in steam shall be equipped with This recording device may be combined a globe valve or other equivalent-type with the steam controller and may be a valve or piping arrangement that will recording/controlling instrument. prevent leakage of air into the retort When compared to the known accurate during the process cycle. indicating temperature device, the recording accuracy shall be equal to or (5) Water valves. All retort water lines better than 1F °(or 0.5C°) at the process that are intended to be closed during a temperature. The temperature record- process cycle shall be equipped with a ing chart should be adjusted to agree globe valve or other equivalent-type with, but shall never be higher than, valve or piping arrangement that will the known accurate indicating tem- prevent leakage of water into the re- perature device. A means of preventing tort during the process cycle. unauthorized changes in the adjust- (b) Pressure processing in steam—(1) ment shall be provided. For example, a Batch still retorts. (i) The basic require- lock or a notice from management ments and recommendations for indi- posted at or near the recording device cating temperature devices and tem- warning that only authorized persons perature/time recording devices are de- are permitted to make adjustments, scribed in paragraphs (a) (1) and (2) of are satisfactory means for preventing this section. Additionally, bulb sheaths unauthorized changes. Air-operated or probes of indicating temperature de- temperature controllers shall have ade- vices and probes of temperature/time quate filter systems to ensure a supply recording devices shall be installed ei- of clean, dry air. The recorder timing ther within the retort shell or in exter- mechanism shall be accurate. nal wells attached to the retort. Exter- (i) Chart-type devices. Devices using nal wells shall be connected to the re- charts shall be used only with the cor- tort through at least a 3⁄4 inch (1.9 cm) rect chart. Each chart shall have a diameter opening and equipped with a working scale of not more than 55F°/ 1⁄16 inch (1.6 mm) or larger bleeder inch (or 12C°/cm) within a range of 20F opening so located as to provide a con- °(or 11C°) of the process temperature. stant flow of steam past the length of Chart graduations shall not exceed 2F the bulb or probe. The bleeder for ex- degrees (or 1C degree) within a range of ternal wells shall emit steam continu- 10F degrees (or 5C degrees) of the proc- ously during the entire thermal process temperature. Multipoint plotting essing period. chart-type devices shall print tempera- (ii) Steam controllers are required as ture readings at intervals that will as- described under paragraph (a)(3) of this sure that the parameters of the process section.

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(iii) Steam inlet. The steam inlet to above the level of the lowest container, each retort shall be large enough to a bleeder shall be installed in the bot- provide steam for proper operation of tom of the retort to remove conden- the retort, and shall enter at a point to sate. The condensate bleeder shall be facilitate air removal during venting. so arranged that the retort operator (iv) Crate supports. Vertical still re- can observe that it is functioning prop- torts with bottom steam entry shall erly. The condensate bleeder shall be employ bottom retort crate supports. checked with sufficient frequency to Baffle plates shall not be used in the ensure adequate removal of conden- bottom of retorts. sate. Visual checks should be per- (v) Steam spreader. Perforated steam formed at intervals of not more than 15 spreaders, if used, shall be maintained minutes and the results recorded. to ensure they are not blocked or oth- Intermittent condensate removal sys- erwise inoperative. Horizontal still re- tems shall be equipped with an auto- torts shall be equipped with perforated matic alarm system that will serve as steam spreaders that extend the full a continuous monitor of condensate length of the retort unless the ade- bleeder functioning. The automatic quacy of another arrangement is docu- alarm system shall be tested at the be- mented by heat distribution data or ginning of each shift for proper func- other documentation from a processing tioning and the results recorded. If the authority. Such information shall be alarm system is not functioning prop- maintained on file by the establish- erly, it must be repaired before the re- ment and made available to Program tort is used. employees for review. (vii) Stacking equipment—(a) Equip- (vi) Bleeders and condensate removal. ment for holding or stacking containers in Bleeders, except those for external retorts. Crates, trays, gondolas, carts, wells of temperature devices, shall and other vehicles for holding or stack- have 1⁄8 inch (or 3 mm) or larger opening product containers in the retort ings and shall be wide open during the shall be so constructed to ensure steam entire process, including the come-up circulation during the venting, come- time. For horizontal still retorts, up, and process times. The bottom of bleeders shall be located within ap- each vehicle shall have perforations at proximately 1 foot (or 30 cm) of the least 1 inch (2.5 cm) in diameter on 2 outermost locations of containers at inch (or 5 cm) centers or the equivalent each end along the top of the retort. unless the adequacy of another ar- Additional bleeders shall be located rangement is documented by heat dis- not more than 8 feet (2.4 m) apart along tribution data or other documentation the top. Bleeders may be installed at from a processing authority and such positions other than those specified information is maintained on file by above, as long as the establishment has the establishment and made available heat distribution data or other docu- to Program employees for review. mentation from the manufacturer or (b) Divider plates. Whenever one or from a processing authority dem- more divider plates are used between onstrating that the bleeders accom- any two layers of containers or placed plish removal of air and circulate the on the bottom of a retort vehicle, the steam within the retort. This informa- establishment shall have on file docu- tion shall be maintained on file by the mentation that the venting procedure establishment and made available to allows the air to be removed from the Program employees for review. All retort before timing of the thermal bleeders shall be arranged in a way process is started. Such documentation that enables the retort operator to ob- shall be in the form of heat distribu- serve that they are functioning prop- tion data or documentation from a erly. Vertical retorts shall have at processing authority. This information least one bleeder opening located in shall be made available to Program the portion of the retort opposite the employees for review. steam inlet. All bleeders shall be ar- (viii) Bleeder and vent mufflers. If muf- ranged so that the retort operator can flers are used on bleeders or vent sys- observe that they are functioning prop- tems, the establishment shall have on erly. In retorts having a steam inlet file documentation that the mufflers

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do not impede the removal of air from (d) For crateless retort installations, the retort. Such documentation shall the establishment shall have heat dis- consist of either heat distribution data tribution data or other documentation or documentation from the muffler from the equipment manufacturer or manufacturer or from a processing au- from a processing authority that dem- thority. This information shall be onstrates that the venting procedure made available to Program employees used accomplishes the removal of air for review. and condensate. This information shall (ix) Vents—(a) Vents shall be located be maintained on file by the establish- in that portion of the retort opposite ment and made available to Program the steam inlet and shall be designed, employees for review. installed, and operated in such a way (e) Examples of typical installations and operating procedures that comply that air is removed from the retort be- with the requirements of this section fore timing of the thermal process is are as follows: started. Vents shall be controlled by a (1) Venting horizontal retorts. gate, plug cock, or other full-flow valve (i) Venting through multiple 1 inch which shall be fully opened to permit (2.5 cm) vents discharging directly to rapid removal of air from retorts dur- the atmosphere. ing the venting period. (b) Vents shall not be connected to a closed drain system without an atmospheric break in the line. Where a retort manifold connects several pipes from a single retort, the manifold shall be controlled by a gate, plug cock, or other full-flow valve and the manifold shall be of a size such that the cross- sectional area of the manifold is larger than the total cross-sectional area of all connecting vents. The discharge shall not be connected to a closed drain Specifications (Figure 1): One, 1-inch (2.5 cm) without an atmospheric break in the vent for every 5 feet (1.5 m) of retort length, equipped with a gate, plug cock, or other line. A manifold header connecting full-flow valve and discharging to atmos- vents or manifolds from several still phere. The end vents shall not be more than retorts shall lead to the atmosphere. 21⁄2 feet (or 75 cm) from ends of retort. Vent- The manifold header shall not be con- ing method (Figure 1): Vent valves shall be trolled by a valve and shall be of a size wide open for at least 5 minutes and to at such that the cross-sectional area is at least 225 °F (or 107 °C), or at least 7 minutes least equal to the total cross-sectional and to at least 220 °F (or 104.5 °C). area of all connecting retort manifold (ii) Venting through multiple 1 inch pipes from the maximum number of re- (2.5 cm) vents discharging through a torts to be vented simultaneously. manifold to the atmosphere. (c) Some typical installations and operating procedures are described below. Other retort installations, vent piping arrangements, operating procedures or auxiliary equipment such as divider plates may be used provided there is documentation that the air is removed from the retort before the process is started. Such documentation shall be in the form of heat distribution data or other documentation from the equipment manufacturer or processing au- Specifications (Figure 2): One, 1-inch (2.5 cm) thority. This information shall be vent for every 5 feet (1.5 m) of retort length; maintained on file by the establish- vents not over 21⁄2 feet (or 75 cm) from ends ment and made available to Program of retort; size of manifold for retorts less employees for review. than 15 feet (4.6 m) in length, 21⁄2 inches (6.4

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cm), and for retorts 15 feet (4.6 m) and over Specifications (Figure 4): A 21⁄2 inch (6.4 cm) in length, 3 inches (7.6 cm). vent equipped with a 21⁄2 inch (6.4 cm) gate, Venting method (Figure 2): The manifold plug cock, or other full-flow valve and lo- vent gate, plug cock, or other full-flow valve cated within 2 feet (61 cm) of the center of shall be wide open for at least 6 minutes and the retort. to at least 225 °F (or 107 °C) or for at least 8 Venting method (Figure 4): The vent valve minutes and to at least 220 °F (or 104.5 °C). shall be wide open for at least 4 minutes and to at least 220 °F (or 104.5 °C). (iii) Venting through water spreaders. (2) Venting vertical retorts. (i) Venting through a 11⁄2 inch (3.8 cm) overflow.

(iv) Venting through a single 21⁄2 inch (6.4 cm) top vent for retorts not exceed- FIGURE 5

ing 15 feet (4.6 m) in length. Specifications (Figure 5): A 11⁄2 inch (3.8 cm) overflow pipe equipped with a 11⁄2 inch (3.8 cm) gate, plug cock, or other full-flow valve and with not more than 6 feet (1.8 m) of 11⁄2 inch (3.8 cm) pipe beyond the valve before a break to the atmosphere or to a manifold header. Venting method (Figure 5): The vent valve shall be wide open for at least 4 minutes and to at least 218 °F (or 103.5 °C), or for at least 5 minutes and to at least 215 °F (or 101.5 °C). (ii) Venting through a single 1 inch (2.5 cm) side or top vent.

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Specifications (Figure 6 or 7): A 1 inch (2.5 (ii) Steam controllers are required as cm) vent in lid or top side, equipped with a described in paragraph (a)(3) of this gate, plug cock, or other full-flow valve and section. discharging directly into the atmosphere or (iii) Steam inlet. The steam inlet to to a manifold header. each retort shall be large enough to Venting method (Figure 6 or 7): The vent valve shall be wide open for at least 5 min- provide steam for proper operation of utes and to at least 230 °F (110 °C), or for at the retort and shall enter at a point(s) least 7 minutes and to at least 220 °F (or 104.5 to facilitate air removal during vent- °C). ing. (iv) Bleeders. Bleeders, except those (2) Batch agitating retorts. (i) The for external wells of temperature de- basic requirements for indicating tem- vices, shall be 1⁄8 inch (or 3 mm) or larg- perature devices and temperature/time er and shall be wide open during the recording devices are described in para- entire process including the come-up graphs (a) (1) and (2) of this section. time. Bleeders shall be located within Additionally, bulb sheaths or probes of approximately 1 foot (or 30 cm) of the indicating temperature devices and outermost location of containers, at probes of temperature/time recording each end along the top of the retort. devices shall be installed either within Additional bleeders shall be located the retort shell or in external wells at- not more than 8 feet (2.4 m) apart along tached to the retort. External wells the top. Bleeders may be installed at shall be connected to the retort positions other than those specified through at least a 3⁄4 inch (1.9 cm) di- above, as long as the establishment has ameter opening and equipped with a 1⁄16 heat distribution data or other docu- (1.6 mm) or larger bleeder opening so mentation from the manufacturer or located as to provide a constant flow of from a processing authority that the steam past the length of the bulbs or bleeders accomplish removal of air and probes. The bleeder for external wells circulate the steam within the retort. shall emit steam continuously during This information shall be maintained the entire thermal processing period. on file by the establishment and made

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available to Program employees for re- that only authorized persons are per- view. All bleeders shall be arranged in mitted to make adjustments are satis- a way that enables the retort operator factory means of preventing unauthor- to observe that they are functioning ized changes. properly. (vii) Bleeder and vent mufflers. If muf- (v) Venting and condensate removal. flers are used on bleeders or vent sys- The air in the retort shall be removed tems, the establishment shall have doc- before processing is started. Heat dis- umentation that the mufflers do not tribution data or other documentation impede the removal of air from the re- from the manufacturer or from the tort. Such documentation shall consist processing authority who developed the of either heat distribution data or doc- venting procedure shall be kept on file umentation from the muffler manufac- by the establishment and made avail- turer or from a processing authority. able to Program employees for review. This information shall be maintained At the time the steam is turned on, the on file by the establishment and made drain shall be opened to remove steam available to Program employees for re- condensate from the retort. A bleeder view. shall be installed in the bottom of the (3) Continuous rotary retorts. (i) The retort to remove condensate during re- basic requirements for indicating tem- tort operation. The condensate bleeder perature devices and temperature/time shall be so arranged that the retort op- recording devices are described in para- erator can observe that it is func- graphs (a) (1) and (2) of this section. tioning properly. The condensate Additionally, bulb sheaths or probes of bleeder shall be checked with sufficient indicating temperature devices and frequency to ensure adequate removal probes of temperature/time recording of condensate. Visual checks should be devices shall be installed either within performed at intervals of not more the retort shell or in external wells at- than 15 minutes and the results re- tached to the retort. External wells corded. Intermittent condensate re- shall be connected to the retort moval systems shall be equipped with through at least a 3⁄4 inch (1.9 cm) dian automatic alarm system that will ameter opening and equipped with a 1⁄16 serve as a continuous monitor of con- inch (1.6 mm) or larger bleeder opening densate bleeder functioning. The auto- so located as to provide a constant flow matic alarm system shall be tested at of steam past the length of the bulbs or the beginning of each shift for proper probes. The bleeder for external wells functioning and the results recorded. If shall emit steam continuously during the alarm system is not functioning the entire thermal processing period. properly, it must be repaired before the (ii) Steam controllers are required as retort is used. described in paragraph (a)(3) of this (vi) Retort or reel speed timing. The re- section. tort or reel speed shall be checked be- (iii) Steam inlet. The steam inlet to fore process timing begins and, if need- each retort shall be large enough to ed, adjusted as specified in the process provide steam for proper operation of schedule. In addition, the rotational the retort, and shall enter at a point(s) speed shall be determined and recorded to facilitate air removal during vent- at least once during process timing of ing. each retort load processed. Alter- (iv) Bleeders. Bleeders, except those natively, a recording tachometer can for external wells of temperature de- be used to provide a continuous record vices, shall be 1⁄8 inch (3.2 mm) or larg- of the speed. The accuracy of the re- er and shall be wide open during the cording tachometer shall be deter- entire process, including the come-up mined and recorded at least once per time. B!eeders shall be located within shift by checking the retort or reel approximately 1 foot (or 30 cm) of the speed using an accurate stopwatch. A outermost location of containers at means of preventing unauthorized each end along the top of the retort. speed changes on retorts shall be pro- Additional bleeders shall be located vided. For example, a lock or a notice not more than 8 feet (2.4 m) apart along from management posted at or near the top of the retort. Bleeders may be the speed adjustment device warning installed at positions other than those

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specified above, as long as the estab- used, the speed shall be manually lishment has heat distribution data or checked against an accurate stopwatch other documentation from the manu- at least once per shift and the results facturer or a processing authority that recorded. A means of preventing unau- the bleeders accomplish removal of air thorized speed changes on retorts shall and circulate the steam within the re- be provided. For example, a lock or a tort. This information shall be main- notice from management posted at or tained on file by the establishment and near the speed adjustment device warn- made available to Program employees ing that only authorized persons are for review. All bleeders shall be ar- permitted to make adjustments are ranged so that the retort operator can satisfactory means of preventing unau- observe that they are functioning prop- thorized changes. erly. (vii) Bleeders and vent mufflers. If muf- (v) Venting and condensate removal. flers are used on bleeders or vent sys- The air in the retort shall be removed tems, the establishment shall have doc- before processing is started. Heat dis- umentation that the mufflers do not tribution data or other documentation impede the removal of air from the re- from the manufacturer or from the tort. Such documentation shall consist processing authority who deve!oped the of either heat distribution data or venting procedure shall be kept on file other documentation from the muffler by the establishment and made avail- manufacturer or from a processing au- able to Program employees for review. thority. This information shall be At the time the steam is turned on, the maintained on file by the establish- drain shall be opened to remove steam ment and made available to Program condensate from the retort. A bleeder employees for review. shall be installed in the bottom of the (4) Hydrostatic retorts. (i) The basic re- shell to remove condensate during the quirements for indicating temperature retort operation. The condensate bleed- devices and temperature/time recorder shall be so arranged that the retort ing devices are described in paragraphs operator can observe that it is func- (a) (1) and (2) of this section. Addition- tioning properly. The condensate ally, indicating temperature devices bleeder shall be checked with sufficient frequency to ensure adequate removal shall be located in the steam dome of condensate. Visual checks should be near the steam/water interface. Where performed at intervals of not more the process schedule specifies mainte- than 15 minutes and the results re- nance of particular water temperatures corded. Intermittent condensate rein the hydrostatic water legs, at least moval systems shall be equipped with one indicating temperature device an automatic alarm system that will shall be located in each hydrostatic serve as a continuous monitor of con- water leg so that it can accurately densate bleeder functioning. The auto- measure water temperature and be eas- matic alarm system shall be tested at ily read. The temperature/time re- the beginning of each shift for proper corder probe shall be installed either functioning and the results recorded. If within the steam dome or in a well at- the alarm system is not functioning tached to the dome. Each probe shall properly, it must be repaired before the have a 1⁄16 inch (1.6 mm) or larger bleed- retort is used. er opening which emits steam continu- (vi) Retort speed timing. The rota- ously during the processing period. Ad- tional speed of the retort shall be spec- ditional temperature/time recorder ified in the process schedule. The speed probes shall be installed in the hydro- shall be adjusted as specified, and re- static water legs if the process sched- corded by the establishment when the ule specifies maintenance of particular retort is started, and checked and re- temperatures in these water legs. corded at intervals not to exceed 4 (ii) Steam controllers are required as hours to ensure that the correct retort described in paragraph (a)(3) of this speed is maintained. Alternatively, a section. recording tachometer may be used to (iii) Steam inlet. The steam inlets provide a continuous record of the shall be large enough to provide steam speed. If a recording tachometer is for proper operation of the retort.

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(iv) Bleeders. Bleeder openings 1⁄4 inch ments for indicating temperature de- (or 6 mm) or larger shall be located in vices and temperature/time recording the steam chamber(s) opposite the devices are described in paragraphs point of steam entry. Bleeders shall be (a)(1) and (2) of this section. Addition- wide open and shall emit steam con- ally, bulbs or probes of indicating tem- tinuously during the entire process, in- perature devices shall be located in cluding the come-up time. All bleeders such a position that they are beneath shall be arranged in such a way that the surface of the water throughout the operator can observe that they are the process. On horizontal retorts, the functioning properly. indicating temperature device bulb or (v) Venting. Before the start of proc- probe shall be inserted directly into essing operations, the retort steam the retort shell. In both vertical and chamber(s) shall be vented to ensure horizontal retorts, the indicating tem- removal of air. Heat distribution data perature device bulb or probe shall ex- or other documentation from the man- tend directly into the water a min- ufacturer or from a processing author- imum of 2 inches (or 5 cm) without a ity demonstrating that the air is re- separable well or sleeve. In vertical removed from the retort prior to proc- torts equipped with a recorder/con- essing shall be kept on file at the es- troller, the controller probe shall be lo- tablishment and made available to cated at the bottom of the retort below Program employees for review. the lowest crate rest in such a position (vi) Conveyor speed. The conveyor that the steam does not strike it di- speed shall be calculated to obtain the rectly. In horizontal retorts so required process time and recorded by equipped, the controller probe shall be the establishment when the retort is located between the water surface and started. The speed shall be checked and the horizontal plane passing through recorded at intervals not to exceed 4 the center of the retort so that there is hours to ensure that the correct con- no opportunity for direct steam im- veyor speed is maintained. A recording pingement on the controller probe. Air- device may be used to provide a contin- operated temperature controllers shall uous record of the conveyor speed. have filter systems to ensure a supply When a recording device is used, the of clean, dry air. speed shall be manually checked (ii) Pressure recording device. Each re- against an accurate stopwatch at least tort shall be equipped with a pressure once per shift by the establishment. A recording device which may be com- means of preventing unauthorized bined with a pressure controller. speed changes of the conveyor shall be (iii) Steam controllers are required as provided. For example, a lock or a no- described in paragraph (a)(3) of this tice from management posted at or section. near the speed adjustment device warn- (iv) Heat distribution. Heat distribu- ing that only authorized persons are tion data or other documentation from permitted to make adjustments are the equipment manufacturer or a proc- satisfactory means of preventing unau- essing authority demonstrating uni- thorized changes. form heat distribution within the re- (vii) Bleeders and vent mufflers. If muf- tort shall be kept on file at the estab- flers are used on bleeders or vent sys- lishment and made available to Pro- tems, the establishment shall have doc- gram employees for review. umentation that the muffler do not im- (v) Crate supports. A bottom crate pede the removal of air from the retort. support shall be used in vertical re- Such documentation shall consist of ei- torts. Baffle plates shall not be used in ther heat distribution data or other the bottom of the retort. documentation from the muffler manu- (vi) Stacking equipment. For filled facturer or from a processing author- flexible containers and, where applica- ity. This information shall be main- ble, semirigid containers, stacking tained on file by the establishment and equipment shall be designed to ensure made available to Program employees that the thickness of the filled con- for review. tainers does not exceed that specified (c) Pressure processing in water—(1) in the process schedule and that the Batch still retorts. (i) The basic require- containers do not become displaced and

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overlap or rest on one another during (x) Water recirculation. When a water the thermal process. recirculation system is used for heat (vii) Drain valve. A nonclogging, distribution, the water shall be drawn water-tight drain valve shall be used. from the bottom of the retort through Screens shall be installed over all drain a suction manifold and discharged openings. through a spreader that extends the (viii) Water level. There shall be a length or circumference of the top of means of determining the water level the retort. The holes in the water in the retort during operation (i.e., by spreader shall be uniformly distrib- using a gauge, electronic sensor, or uted. The suction outlets shall be pro- sight glass indicator). For retorts re- tected with screens to keep debris from quiring complete immersion of con- entering the recirculation system. The tainers, water shall cover the top layer pump shall be equipped with a pilot of containers during the entire come- light or a similar device to warn the up time and thermal processing periods operator when it is not running, and with a bleeder to remove air when and should cover the top layer of con- starting operations. Alternatively, a tainers during cooling. For retorts flow-meter alarm system can be used using cascading water or water sprays, to ensure proper water circulation. The the water level shall be maintained adequacy of water circulation for within the range specified by the retort maintaining uniform heat distribution manufacturer or processing authority within the retort shall be documented during the entire come-up, thermal by heat distribution or other docu- processing, and cooling periods. A mentation from a processing authority means to ensure that water circulation and such data shall be maintained on continues as specified throughout the file by the establishment and made come-up, thermal processing, and cool- available to Program employees for re- ing periods shall be provided. The review. Alternative methods for recir- tort operator shall check and record culation of water in the retort may be the water level at intervals to ensure it used, provided there is documentation meets the specified processing param- in the form of heat distribution data or eters. other documentation from a processing (ix) Air supply and controls. In both authority maintained on file by the es- horizontal and vertical still retorts, a tablishment and made available to means shall be provided for introducing Program employees for review. compressed air or steam at the pres- (xi) Cooling water entry. In retorts for sure required to maintain container in- processing product packed in glass jars, tegrity. Compressed air and steam the incoming cooling water should not entry shall be controlled by an auto- directly strike the jars, in order to matic pressure control unit. A non- minimize glass breakage by thermal return valve shall be provided in the shock. air supply line to prevent water from (2) Batch agitating retorts. (i) The entering the system. Overriding air or basic requirements and recommenda- steam pressure shall be maintained tions for indicating temperature de- continuously during the come-up, ther- vices and temperature/time recording mal processing, and cooling periods. If devices are described in paragraphs (a) air is used to promote circulation, it (1) and (2) of this section. Additionally, shall be introduced into the steam line the indicating temperature device bulb at a point between the retort and the or probe shall extend directly into the steam control valve at the bottom of water without a separable well or the retort. The adequacy of the air cir- sleeve. The recorder/controller probe culation for maintaining uniform heat shall be located between the water sur- distribution within the retort shall be face and the horizontal plane passing documented by heat distribution data through the center of the retort so that or other documentation from a proc- there is no opportunity for steam to di- essing authority, and such data shall rectly strike the controller bulb or be maintained on file by the establish- probe. ment and made available to Program (ii) Pressure recording device. Each re- employees for review. tort shall be equipped with a pressure

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recording device which may be com- tribution data or other documentation bined with a pressure controller. from a processing authority, and such (iii) Steam controllers are required data shall be maintained on file by the as described in paragraph (a)(3) of this establishment and made available to section. Program employees for review. (iv) Heat distribution. Heat distribu- (ix) Retort or reel speed timing. The re- tion data or other documentation from tort or reel speed timing shall be the equipment manufacturer or a proc- checked before process timing begins essing authority shall be kept on file and, if needed, adjusted as specified in by the establishment and made avail- the process schedule. In addition, the able to Program employees for review. rotational speed shall be determined (v) Stacking equipment. All devices and recorded at least once during proc- used for holding product containers ess timing of each retort load proc- (e.g., crates, trays, divider plates) shall essed. Alternatively, a recording ta- be so constructed to allow the water to chometer can be used to provide a con- circulate around the containers during tinuous record of the speed. The accu- the come-up and thermal process peri- racy of the recording tachometer shall ods. be determined and recorded at least (vi) Drain valve. A nonclogging, once per shift by the establishment by water-tight drain valve shall be used. checking the retort or reel speed using Screens shall be installed over all drain an accurate stopwatch. A means of pre- openings. venting unauthorized speed changes on (vii) Water level. There shall be a retorts shall be provided. For example, means of determining the water level a lock or a notice from management in the retort during operation (i.e., by posted at or near the speed adjustment using a gauge, electronic sensor, or device warning that only authorized sight glass indicator). Water shall com- persons are permitted to make adjust- pletely cover all containers during the ments are satisfactory means of pre- entire come-up, thermal processing, venting unauthorized changes. and cooling periods. A means to ensure (x) Water recirculation. If a water re- that water circulation continues as circulation system is used for heat dis- specified throughout the come-up, tribution, it shall be installed in such a thermal processing, and cooling periods manner that water will be drawn from shall be provided. The retort operator the bottom of the retort through a suc- shall check and record the adequacy of tion manifold and discharged through a the water level with sufficient fre- spreader which extends the length of quency to ensure it meets the specified the top of the retort. The holes in the processing parameters. water spreader shall be uniformly dis- (viii) Air supply and controls. Retorts tributed. The suction outlets shall be shall be provided with a means for in- protected with screens to keep debris troducing compressed air or steam at from entering the recirculation sys- the pressure required to maintain con- tem. The pump shall be equipped with tainer integrity. Compressed air and a pilot light or a similar device to warn steam entry shall be controlled by an the operator when it is not running and automatic pressure control unit. A with a bleeder to remove air when nonreturn valve shall be provided in starting operations. Alternatively, a the air supply line to prevent water flow-meter alarm system can be used from entering the system. Overriding to ensure proper water circulation. The air or steam pressure shall be main- adequacy of water circulation for tained continuously during the come- maintaining uniform heat distribution up, thermal processing, and cooling pe- within the retort shall be documented riods. If air is used to promote circula- by heat distribution data or other doc- tion, it shall be introduced into the umentation from a processing author- steam line at a point between the re- ity, and such data shall be maintained tort and the steam control valve at the on file by the establishment and made bottom of the retort. The adequacy of available to Program employees for re- the air circulation for maintaining uni- view. Alternative methods for recir- form heat distribution within the re- culation of water in the retort may be tort shall be documented by heat dis- used provided there is documentation

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in the form of heat distribution data or ments described in paragraph (a)(2) of other documentation from a processing this section. authority maintained on file by the es- (2) Heat distribution. Each atmos- tablishment and made available to pheric cooker shall be equipped and op- Program employees for review. erated to ensure uniform heat distribu- (xi) Cooling water entry. In retorts for tion throughout the processing system processing product packed in glass jars, during the thermal process. Heat dis- the incoming cooling water should not tribution data or other documentation directly strike the jars, in order to from the manufacturer or a processing minimize glass breakage by thermal authority demonstrating uniform heat shock. distribution within the cooker shall be (d) Pressure processing with steam/air kept on file by the establishment and mixtures in batch retorts. (1) The basic made available to Program employees requirements for indicating tempera- for review. ture devices and temperature/time re- (f) Other systems. All other systems cording devices are described in para- not specifically delineated in this sec- graphs (a) (1) and (2) of this section. tion and used for the thermal proc- Additionally, bulb sheaths or probes essing of canned product shall be ade- for indicating temperature devices and quate to produce shelf-stable products temperature/time recording devices or consistently and uniformly. controller probes shall be inserted di- (g) Equipment maintenance. (1) Upon rectly into the retort shell in such a installation, all instrumentation and position that steam does not strike controls shall be checked by the estab- them directly. lishment for proper functioning and accuracy and, thereafter, at any time (2) Steam controllers are required as their functioning or accuracy is sus- described in paragraph (a)(3) of this pect. section. (2) At least once a year each thermal (3) Recording pressure controller. A reprocessing system shall be examined by cording pressure controller shall be an individual not directly involved in used to control the air inlet and the daily operations to ensure the proper steam/air mixture outlet. functioning of the system as well as all (4) Circulation of steam/air mixtures. A auxiliary equipment and instrumenta- means shall be provided for the circulation. In addition, each thermal proc- tion of the steam/air mixture to pre- essing system should be examined be- vent formation of low-temperature fore the resumption of operation fol- pockets. The efficiency of the circula- lowing an extended shutdown. tion system shall be documented by (3) Air and water valves that are in- heat distribution data or other docu- tended to be closed during thermal mentation from a processing authority, processing shall be checked by the es- and such data shall be maintained on tablishment for leaks. Defective valves file by the establishment and made shall be repaired or replaced as needed. available to Program employees for re- (4) Vent and bleeder mufflers shall be view. The circulation system shall be checked and maintained or replaced by checked to ensure its proper func- the establishment to prevent any re- tioning and shall be equipped with a duction in vent or bleeder efficiency. pilot light or a similar device to warn (5) When water spreaders are used for the operator when it is not func- venting, a maintenance schedule shall tioning. Because of the variety of exist- be developed and implemented to as- ing designs, reference shall be made to sure that the holes are maintained at the equipment manufacturer for de- their original size. tails of installation, operation, and (6) Records shall be kept on all main- control. tenance items that could affect the (e) Atmospheric cookers—(1) Tempera- adequacy of the thermal process. ture/time recording device. Each atmos- Records shall include the date and type pheric cooker (e.g., hot water bath) of maintenance performed and the per- shall be equipped with at least one son conducting the maintenance. temperature/time recording device in (h) Container cooling and cooling accordance with the basic require- water. (1) Potable water shall be used

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for cooling except as provided for in no buildup of microorganisms on sur- paragraphs (h) (2) and (3) of this sec- faces in contact with the containers. tion. (Approved by the Office of Management and (2) Cooling canal water shall be Budget under control number 0583–0015) chlorinated or treated with a chemical approved by the Administrator as hav- [51 FR 45619, Dec. 19, 1986, as amended at 65 FR 34389, May 30, 2000] ing a bactericidal effect equivalent to chlorination. There shall be a measur- § 318.306 Processing and production able residual of the sanitizer in the records. water at the discharge point of the At least the following processing and canal. Cooling canals shall be cleaned production information shall be re- and replenished with potable water to corded by the establishment: date of prevent the buildup of organic matter production; product name and style; and other materials. container code; container size and (3) Container cooling waters that are type; and the process schedule, includ- recycled or reused shall be handled in ing the minimum initial temperature. systems that are so designed, operated, Measurements made to satisfy the re- and maintained so there is no buildup quirements of § 318.303 regarding the of microorganisms, organic matter, control of critical factors shall be re- and other materials in the systems and corded. In addition, where applicable, in the waters. System equipment, such the following information and data as pipelines, holding tanks and cooling shall also be recorded: towers, shall be constructed and in- (a) Processing in steam—(1) Batch still stalled so that they can be cleaned and retorts. For each retort batch, record inspected. In addition, the establish- the retort number or other designa- ment shall maintain, and make avail- tion, the approximate number of con- able to Program employees for review, tainers or the number of retort crates information on at least the following: per retort load, product initial tem- (i) System design and construction; perature, time steam on, the time and (ii) System operation including the temperature vent closed, the start of rates of renewal with fresh, potable process timing, time steam off, and the water and the means for treating the actual processing time. The indicating water so that there is a measurable re- temperature device and the tempera- sidual of an acceptable sanitizer, per ture recorder shall be read at the same paragraph (h)(2) of this section, in the time at least once during process tim- water at the point where the water ing and the observed temperatures re- exits the container cooling vessel; corded. (iii) System maintenance including (2) Batch agitating retorts. In addition procedures for the periodic cleaning to recording the information required and sanitizing of the entire system; for batch, still steam retorts in para- and graph (a)(1) of this section, record the (iv) Water quality standards, such as functioning of the condensate bleed- microbiological, chemical and phys- er(s) and the retort or reel speed. ical, monitoring procedures including (3) Continuous rotary retorts. Record the frequency and site(s) of sampling, the retort system number, the approxi- and the corrective actions taken when mate total number of containers re- water quality standards are not met. torted, product initial temperature, (i) Post-process handling of containers time steam on, the time and tempera- Containers shall be handled in a man- ture vent closed, time process tempera- ner that will prevent damage to the ture reached, the time the first can en- hermetic seal area. All worn and frayed ters and the time the last can exits the belting, can retarders, cushions, and retort. The retort or reel speed shall be the like shall be replaced with non- determined and recorded at intervals porous materials. To minimize con- not to exceed 4 hours. Readings of the tainer abrasions, particularly in the indicating temperature device(s) and seal area, containers should not remain temperature recorder(s) shall be made stationary on moving conveyors. All and recorded at the time the first con- post-process container handling equip- tainer enters the retort and thereafter ment should be kept clean so there is with sufficient frequency to ensure

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compliance with the process schedule. in paragraph (b)(1) of this section, These observations should be made and record the retort or reel speed. recorded at intervals not exceeding 30 (c) Processing in steam/air mixtures. minutes of continuous retort oper- For each retort batch, record the re- ation. Functioning of the condensate tort number or other designation, the bleeder(s) shall be observed and re- approximate number of containers or corded at the time the first container number of retort crates per retort load, enters the retort and thereafter as product initial temperature, time specified in § 318.305(b)(3)(v). steam on, venting procedure, if appli- (4) Hydrostatic retorts. Record the re- cable, the start of process timing, tort system number, the approximate maintenance of circulation of the total number of containers retorted, steam/air mixture, air flow rate or forced recirculation flow rate (if crit- product initial temperature, time ical), overriding pressure maintained, steam on, the time and temperature time steam off, and actual processing vent(s) closed, time process tempera- time. The indicating temperature de- ture reached, time first containers vice and the temperature recorder shall enter the retort, time last containers be read at the same time at least once exit the retort, and, if specified in the during process timing and the observed process schedule, measurements of temperatures recorded. temperatures in the hydrostatic water (d) Atmospheric cookers—(1) Batch-type legs. Readings of the temperature indi- systems. For each cooker batch, record cating device, which is located in the the cooker number or other designa- steam/water interface, and the tem- tion and the approximate number of perature recording device shall be ob- containers. In addition, record all crit- served and the temperatures recorded ical factors of the process schedule at the time the first containers enter such as cooker temperature, initial the steam dome. Thereafter, these in- temperature, the time the thermal struments shall be read and the tem- process cycle begins and ends, hold peratures recorded with sufficient fre- time, and the final internal product quency to ensure compliance with the temperature. temperature specified in the process (2) Continuous-type systems. Record schedule and should be made at least the cooker number or other designa- every hour of continuous retort oper- tion, the time the first containers ation. Container conveyor speed, and enter and the last containers exit a for agitating hydrostatic retorts, the cooker, and the approximate total rotative chain speed, shall be deter- number of containers processed. In ad- mined and recorded at intervals of suf- dition, record all critical factors of the ficient frequency to ensure compliance process schedule such as the initial with the process schedule and should temperature, cooker speed, and final be performed at least every 4 hours. internal product temperature. (b) Processing in water—(1) Batch still (Approved by the Office of Management and retorts. For each retort batch, record Budget under control number 0583–0015) the retort number or other designation, the approximate number of con- § 318.307 Record review and mainte- tainers or number of retort crates per nance. retort load, product initial tempera- (a) Process records. Charts from tem- ture, time steam on, the start of proc- perature/time recording devices shall ess timing, water level, water recir- be identified by production date, con- culation rate (if critical), overriding tainer code, processing vessel number pressure maintained, time steam off, or other designation, and other data as and actual processing time. The indi- necessary to enable correlation with cating temperature device and the the records required in § 318.306. Each temperature recorder shall be read at entry on a record shall be made at the the same time at least once during time the specific event occurs, and the process timing and the observed tem- recording individual shall sign or ini- peratures recorded. tial each record form. No later than 1 (2) Batch agitating retorts. In addition working day after the actual process, to recording the information required the establishment shall review all

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processing and production records to § 318.308 Deviations in processing. ensure completeness and to determine (a) Whenever the actual process is if all product received the process less than the process schedule or when schedule. All records, including the any critical factor does not comply temperature/time recorder charts and with the requirements for that factor critical factor control records, shall be as specified in the process schedule, it signed or initialed and dated by the shall be considered a deviation in proc- person conducting the review. All processing. essing and production records required (b) Deviations in processing (or proc- in this subpart shall be made available ess deviations) must be handled accord- to Program employees for review. ing to: (b) Automated process monitoring and (1)(i) A HACCP plan for canned prod- recordkeeping. Automated process mon- uct that addresses hazards associated itoring and recordkeeping systems with microbial contamination, or, shall be designed and operated in a (ii) Alternative documented proce- manner that will ensure compliance dures that will ensure that only safe with the applicable requirements of and stable product is shipped in com- § 318.306. merce; or (c) Container closure records. Written (iii) Paragraph (d) of this section. records of all container closure exami- (c) [Reserved] nations shall specify the container (d) Procedures for handling process code, the date and time of container deviations where the HACCP plan for closure examination, the measure- thermally processed/commercially sterile product does not address food ment(s) obtained, and any corrective safety hazards associated with micro- actions taken. Records shall be signed bial contamination, where there is no or initialed by the container closure approved total quality control system, technician and shall be reviewed and or where the establishment has no al- signed by the establishment within 1 ternative documented procedures for working day after the actual produc- handling process deviations. tion to ensure that the records are (1) Deviations identified in-process. If a complete and that the closing oper- deviation is noted at any time before ations have been properly controlled. the completion of the intended process All container closure examination schedule, the establishment shall: records required in this subpart shall (i) Immediately reprocess the prod- be made available to Program employ- uct using the full process schedule; or ees for review. (ii) Use an appropriate alternate (d) Distribution of product. Records process schedule provided such a proc- shall be maintained by the establish- ess schedule has been established in ac- ment identifying initial distribution of cordance with § 318.302 (a) and (b) and is the finished product to facilitate, if filed with the inspector in accordance necessary, the segregation of specific with § 318.302(c); or production lots that may have been (iii) Hold the product involved and contaminated or are otherwise unsound have the deviation evaluated by a proc- for their intended use. essing authority to assess the safety (e) Retention of records. Copies of all and stability of the product. Upon com- processing and production records re- pletion of the evaluation, the establish- quired in § 318.306 shall be retained for ment shall provide the inspector the no less than 1 year at the establish- following: ment, and for an additional 2 years at (a) A complete description of the de- the establishment or other location viation along with all necessary sup- from which the records can be made porting documentation; available to Program employees within (b) A copy of the evaluation report; 3 working days. and (c) A description of any product dis- (Approved by the Office of Management and position actions, either taken or pro- Budget under control number 0583–0015) posed. [51 FR 45619, Dec. 19, 1986, as amended at 65 (iv) Product handled in accordance FR 34389, May 30, 2000] with paragraph (d)(1)(iii) of this section

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shall not be shipped from the establish- § 318.302(b)) shall be used before con- ment until the Program has reviewed tainer entry to the retort is restarted; all of the information submitted and or (iii) container entry to the retort approved the product disposition ac- shall be prevented and the reel re- tions. started to empty the retort. The dis- (v) If an alternate process schedule is charged containers shall be reproc- used that is not on file with the inspec- essed, repacked and reprocessed, or de- tor or if an alternate process schedule stroyed. Product to be destroyed shall is immediately calculated and used, be handled as ‘‘U.S. Inspected and Con- the product shall be set aside for fur- demned’’, as defined in § 318.2(ee) of this ther evaluation in accordance with subchapter, and disposed of in accord- paragraphs (d)(1)(iii) and (iv) of this ance with part 314 of this subchapter. section. ° (vi) When a deviation occurs in a con- (2) For temperature drops of 10 F (or ° tinuous rotary retort, the product shall 5.5 C) or more, all containers in the re- be handled in accordance with para- tort shall be given an emergency still graphs (d)(1)(iii) and (iv) of this section process (developed per § 318.302(b)). The or in accordance with the following time the reel was stopped and the time procedures: the retort was used for a still retort (a) Emergency stops. process shall be marked on the tem- (1) When retort jams or breakdowns perature/time recording device by the occur during the processing operations, establishment and entered on the other all containers shall be given an emer- production records required in § 318.306. gency still process (developed per Alternatively, container entry to the § 318.302(b)) before the retort is cooled retort shall be prevented and the reel or the retort shall be cooled promptly restarted to empty the retort. The dis- and all containers removed and either charged containers shall be either re- reprocessed, repacked and reprocessed, processed, repacked and reprocessed, or or destroyed. Regardless of the proce- destroyed. Product to be destroyed dure used, containers in the retort in- shall be handled as ‘‘U.S. Inspected and take valve and in transfer valves be- Condemned’’, as defined in § 301.2(ee) of tween retort shells at the time of a jam this subchapter, and disposed of in ac- or breakdown shall be removed and ei- cordance with part 314 of this sub- ther reprocessed, repacked and reproc- chapter. essed and or destroyed. Product to be (2) destroyed shall be handled as ‘‘U.S. In- Deviations identified through record spected and Condemned’’, as defined in review. Whenever a deviation is noted § 301.2(ttt) of this subchapter, and dis- during review of the processing and posed of in accordance with part 314 of production records required by § 318.307 this subchapter. (a) and (b), the establishment shall (2) The time the retort reel stopped hold the product involved and the devi- and the time the retort is used for an ation shall be handled in accordance emergency still retort process shall be with paragraphs (d)(1) (iii) and (iv) of noted on the temperature/time record- this section. ing device and entered on the other (e) Process deviation file. The estab- production records required in § 318.306. lishment shall maintain full records re- (b) Temperature drops. When the regarding the handling of each deviation. tort temperature drops below the tem- Such records shall include, at a min- perature specified in the process sched- imum, the appropriate processing and ule, the reel shall be stopped and the production records, a full description of following actions shall be taken: the corrective actions taken, the eval- (1) For temperature drops of less uation procedures and results, and the ° ° than 10 F (or 5.5 C) either, (i) all con- disposition of the affected product. tainers in the retort shall be given an Such records shall be maintained in a emergency still process (developed per separate file or in a log that contains § 318.302(b)) before the reel is restarted; the appropriate information. The file (ii) container entry to the retort shall or log shall be retained in accordance be prevented and an emergency agitating process (developed per with § 318.307(e) and shall be made

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available to Program employees upon nated, the temperature lowered to request. within the required range, and new sample containers incubated for the re- (Approved by the Office of Management and Budget under control number 0583–0015) quired time. (iii) Product requiring incubation. [51 FR 45619, Dec. 19, 1986, as amended at 53 Shelf stable product requiring incuba- FR 49848, Dec. 12, 1988; 62 FR 45025, Aug. 25, 1997; 65 FR 34389, May 30, 2000; 65 FR 53532, tion includes: Sept. 5, 2000] (a) Low acid products as defined in § 318.300(m); and § 318.309 Finished product inspection. (b) Acidified low acid products as de- (a) Finished product inspections fined in § 318.300(b). must be handled according to: (iv) Incubation samples. (a) From each (1) A HACCP plan for canned product load of product processed in a batch- that addresses hazards associated with type thermal processing system (still microbiological contamination; or agitation), the establishment shall (2) An FSIS-approved total quality select at least one container for incu- control system; bation. (3) Alternative documented proce- (b) For continuous rotary retorts, hy- dures that will ensure that only safe drostatic retorts, or other continuous- and stable product is shipped in com- type thermal processing systems, the merce; or establishment shall select at least one (4) Paragraph (d) of this section. container per 1,000 for incubation. (b)–(c) [Reserved] (c) Only normal-appearing containers (d) Procedures for handling finished shall be selected for incubation. product inspections where the HACCP (v) Incubation time. Canned product plan for thermally processed/commer- requiring incubation shall be incubated cially sterile product does not address for not less than 10 days (240 hours) food safety hazards associated with mi- under the conditions specified in para- crobial contamination, where there is graph (d)(1)(ii) of this section. no approved total quality control sys- (vi) Incubation checks and record main- tem, or where the establishment has no tenance. Designated establishment em- alternative documented procedures for ployees shall visually check all con- handling process deviations. tainers under incubation each working (1) Incubation of shelf stable canned day and the inspector shall be notified product—(i) Incubator. The establish- when abnormal containers are de- ment shall provide incubation facilities tected. All abnormal containers should which include an accurate tempera- be allowed to cool before a final deci- ture/time recording device, an indi- sion on their condition is made. For cating temperature device, a means for each incubation test the establishment the circulation of the air inside the in- shall record at least the product name, cubator to prevent temperature vari- container size, container code, number ations, and a means to prevent unau- of containers incubated, in and out thorized entry into the facility. The dates, and incubation results. The es- Program is responsible for the security tablishment shall retain such records, of the incubator. along with copies of the temperature/ (ii) Incubation temperature. The incu- time recording charts, in accordance bation temperature shall be main- with § 318.307(e). tained at 95±5 °F (35±2.8 °C). If the incu- (vii) Abnormal containers. The finding bation temperature falls below 90 °F (or of abnormal containers (as defined in 32 °C) or exceeds 100 °F (or 38 °C) but § 318.300(a)) among incubation samples does not reach 103 °F (or 39.5 °C), the is cause to officially retain at least the incubation temperature shall be ad- code lot involved. justed within the required range and (viii) Shipping. No product shall be the incubation time extended for the shipped from the establishment before time the sample containers were held the end of the required incubation peat the deviant temperature. If the incu- riod except as provided in this para- bation temperature is at or above 103 graph or paragraph (b) or (c) of this °F (or 39.5 °C) for more than 2 hours, section. An establishment wishing to the incubation test(s) shall be termi- ship product prior to the completion of

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the required incubation period shall this subpart. Upon request, the recall submit a written proposal to the area procedure shall be made available to supervisor. Such a proposal shall in- Program employees for review. clude provisions that will assure that (Approved by the Office of Management and shipped product will not reach the re- Budget under control number 0583–0015) tail level of distribution before sample incubation is completed and that product can be returned promptly to the es- PART 319—DEFINITIONS AND tablishment should such action be STANDARDS OF IDENTITY OR deemed necessary by the incubation COMPOSITION test results. Upon receipt of written approval from the area supervisor, Subpart A—General product may be routinely shipped pro- Sec. vided the establishment continues to 319.1 Labeling and preparation of standard- comply with all requirements of this ized products. subpart. 319.2 Products and nitrates and nitrites. (2) Container condition—(i) Normal 319.5 Mechanically Separated (Species). containers. Only normal-appearing con- 319.6 Limitations with respect to use of Me- chanically Separated (Species). tainers shall be shipped from an estab- 319.10 Requirements for substitute stand- lishment as determined by an appro- ardized meat food products named by use priate sampling plan or other means of an expressed nutrient content claim acceptable to Program employees. and a standardized term. (ii) Abnormal containers. When abnormal containers are detected by any Subpart B—Raw Meat Products means other than incubation, the es- 319.15 Miscellaneous beef products. tablishment shall inform the inspector, 319.29 Miscellaneous pork products. and the affected code lot(s) shall not be shipped until the Program has deter- Subpart C—Cooked Meats mined that the product is safe and sta- 319.80 Barbecued meats. ble. Such a determination will take 319.81 Roast beef parboiled and steam roast- into account the cause and level of ed. abnormals in the affected lot(s) as well as any product disposition actions ei- Subpart D—Cured Meats, Unsmoked and ther taken or proposed by the estab- Smoked lishment. 319.100 Corned beef. (Approved by the Office of Management and 319.101 Corned beef brisket. Budget under control number 0583–0015) 319.102 Corned beef round and other corned beef cuts. [51 FR 45619, Dec. 19, 1986, as amended at 57 319.103 Cured beef tongue. FR 37872, Aug. 21, 1992; 57 FR 55443, Nov. 25, 319.104 Cured pork products. 1992; 62 FR 45025, Aug. 25, 1997; 65 FR 34389, 319.105 ‘‘Ham patties,’’ ‘‘Chopped ham,’’ May 30, 2000; 65 FR 53532, Sept. 5, 2000] ‘‘Pressed ham,’’ ‘‘Spiced ham,’’ and similar products. § 318.310 Personnel and training. 319.106 ‘‘Country Ham,’’ ‘‘Country Style All operators of thermal processing Ham,’’ ‘‘Dry Cured Ham,’’ ‘‘Country Pork systems specified in § 318.305 and con- Shoulder,’’ ‘‘Country Style Pork Shoul- tainer closure technicians shall be der,’’ and ‘‘Dry Cured Pork Shoulder.’’ under the direct supervision of a person 319.107 Bacon. who has successfully completed a Subpart E—Sausage Generally: Fresh school of instruction that is generally Sausage recognized as adequate for properly training supervisors of canning oper- 319.140 Sausage. ations. 319.141 Fresh pork sausage. 319.142 Fresh beef sausage. [51 FR 45619, Dec. 19, 1986] 319.143 Breakfast sausage. 319.144 Whole hog sausage. § 318.311 Recall procedure. 319.145 Italian sausage products. Establishments shall prepare and Subpart F—Uncooked, Smoked Sausage maintain a current procedure for the recall of all canned product covered by 319.160 Smoked pork sausage.

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Subpart G—Cooked Sausage 319.701 Mixed fat shortening. 319.702 Lard, leaf lard. 319.180 Frankfurter, frank, furter, hotdog, 319.703 Rendered animal fat or mixture weiner, vienna, bologna, garlic bologna, thereof. knockwurst, and similar products. 319.181 Cheesefurters and similar products. 319.182 Braunschweiger and liver sausage or Subpart Q—Meat Soups, Soup Mixes, liverwurst. Broths, Stocks, Extracts

Subpart H [Reserved] 319.720 Meat extract. 319.721 Fluid extract of meat. Subpart I—Semi-Dry Fermented Sausage [Reserved] Subpart R—Meat Salads and Meat Spreads Subpart J—Dry Fermented Sausage 319.760 Deviled ham, deviled tongue, and similar products. [Reserved] 319.761 Potted meat food product and dev- Subpart K—Luncheon Meat, Loaves and iled meat food product. Jellied Products 319.762 Ham spread, tongue spread, and similar products. 319.260 Luncheon meat. 319.261 Meat loaf. Subpart S—Meat Baby Foods [Reserved]

Subpart L—Meat Specialties, Puddings and Subpart T—Dietetic Meat Foods [Reserved] Nonspecific Loaves Subpart U—Miscellaneous 319.280 Scrapple. 319.281 Bockwurst. 319.880 Breaded products. 319.881 Liver meat food products. Subpart M—Canned, Frozen, or Dehydrated Meat Food Products AUTHORITY: 7 U.S.C. 450, 1901–1906; 21 U.S.C. 601–695; 7 CFR 2.18, 2.53. 319.300 Chili con carne. 319.301 Chili con carne with beans. SOURCE: 35 FR 15597, Oct. 3, 1970, unless 319.302 Hash. otherwise noted. 319.303 Corned beef hash. 319.304 Meat stews. 319.305 Tamales. Subpart A—General 319.306 Spaghetti with meatballs and sauce, spaghetti with meat and sauce, and simi- § 319.1 Labeling and preparation of lar products. standardized products. 319.307 Spaghetti sauce with meat. (a) Labels for products for which 319.308 Tripe with milk. 319.309 Beans with frankfurters in sauce, standards of identity or composition sauerkraut with wieners and juice, and are prescribed in this part shall show similar products. the appropriate product name, an in- 319.310 Lima beans with ham in sauce, gredient statement, and other label in- beans with ham in sauce, beans with formation in accordance with the spe- bacon in sauce, and similar products. 319.311 Chow mein vegetables with meat, cial provisions, if any, in this part, and and chop suey vegetables with meat. otherwise in accordance with the gen- 319.312 Pork with barbecue sauce and beef eral labeling provisions in part 317 of with barbecue sauce. this subchapter, and such products 319.313 Beef with gravy and gravy with beef. shall be prepared in accordance with Subpart N—Meat Food Entree Products, the special provisions, if any, in this Pies, and Turnovers part and otherwise in accordance with the general provisions in this sub- 319.500 Meat pies. chapter. Any product for which there is a common or usual name must consist Subpart O—Meat Snacks, Hors d’Oeuvres, of ingredients and be prepared by the Pizza, and Specialty Items use of procedures common or usual to 319.600 [Reserved] such products insofar as specific ingredients or procedures are not prescribed Subpart P—Fats, Oils, Shortenings or prohibited by the provisions of this 319.700 Margarine or oleomargarine. subchapter.

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(b) Any binder or antimicrobial agent a measure of a bone solids content of that has been found to be safe and suit- not more than 3 percent, and shall have able by the Food and Drug Administra- a minimum PER of 2.5 (except as modi- tion and the Food Safety and Inspec- fied in paragraph (e)(1) of this section). tion Service may be used in the produc- Such product also shall have a protein tion of meat products with standards of content of not less than 14 percent and identity in this part, where the product a fat content of not more than 30 per- standards and applicable Federal regu- cent, or it shall be deemed to be prod- lations already permit the use of these uct for processing. Such product failing types of ingredients. to meet the bone particle size, calcium, [35 FR 15597, Oct. 3, 1970, as amended at 68 FR or PER requirements of this paragraph 22578, Apr. 29, 2003] shall only be used in producing animal fats. Where such product meets the § 319.2 Products and nitrates and bone particle size, calcium, and PER nitrites. requirements of this paragraph, it may Any product, such as frankfurters also be used in the formulation of meat and corned beef, for which there is a food products in accordance with standard in this part and to which ni- § 319.6. trate or nitrite is permitted or required (b) Mechanically Separated (Beef) is to be added, may be prepared without inedible and prohibited for use as nitrate or nitrite and labeled with such human food. standard name when immediately pre- (c)–(d) [Reserved] ceded with the term ‘‘Uncured’’ in the (e)(1) An essential amino acid con- same size and style of lettering as the tent of at least 33 percent of the total rest of such standard name: Provided, amino acids presents in ‘‘Mechanically That the product is found by the Ad- Separated (Species)’’ shall be accepted ministrator to be similar in size, fla- as evidence of compliance with the pro- vor, consistency, and general appear- tein quality requirement set forth in ance to such product as commonly pre- paragraph (a) of this section. For pur- pared with nitrate and nitrite: And proposes of this paragraph, essential vided further, That labeling for such amino acid content includes isoleucine, product complies with the provisions of leucine, lysine, methionine, § 317.17(c) of this subchapter. phenylalanine, threonine, and valine [44 FR 48961, Aug. 21, 1979] content, and the total amino acids present include isoleucine, leucine, ly- § 319.5 Mechanically Separated (Spe- sine, methionine, phenylalanine, threo- cies). nine, valine, tyrosine, arginine, histi- (a) Mechanically Separated (Species) dine, alanine, aspartic acid, glutamic is any finely comminuted product re- acid, glycine, proline, serine, and sulting from the mechanical separation hydroxyproline content. and removal of most of the bone from (2) Analytical methods used by estab- attached skeletal muscle of livestock lishments in verifying the fat, protein, carcasses and parts of carcasses and and calcium content of product con- meeting the other provisions of this sisting of or containing Mechanically paragraph. Examples of such product Separated (Species) shall be among are ‘‘Mechanically Separated Beef’’, those listed in ‘‘Official Methods of ‘‘Mechanically Separated Veal’’, ‘‘Me- Analysis of the Association of Official chanically Separated Pork’’, and ‘‘Me- Analytical Chemists (AOAC),’’ 16th edi- chanically Separated Lamb’’. At least tion, 1995, §§ 960.39, 976.21, 928.08 (Chap- 98 percent of the bone particles present ter 39), and 940.33 (Chapter 45), which is in such product shall have a maximum incorporated by reference, or, if no size no greater than 0.5 millimeter in AOAC method is available, in the their greatest dimension and there ‘‘Chemistry Laboratory Guidebook,’’ shall be no bone particles larger than U.S. Department of Agriculture, Wash- 0.85 millimeter in their greatest dimen- ington, D.C., March 1986 edition, sec- sion. The product resulting from the tions 6.011–6.013, Revised June 1987 separating process shall not have a cal- (pages 6–35 through 6–65), or by appro- cium content exceeding 0.75 percent, as priate methods validated by scientific

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bodies in collaborative trials. The ‘‘Of- § 319.10 Requirements for substitute ficial Methods of Analysis of the Asso- standardized meat food products ciation of Official Analytical Chem- named by use of an expressed nutri- ists,’’ Chapter 39 and Chapter 45, sub- ent content claim and a standard- section 45.2.06 (AOAC Official Method ized term. 940.33), 16th edition, 1995, are incor- (a) Description. The meat food prod- porated by reference with the approval ucts prescribed by this general defini- of the Director of the Federal Register tion and standard of identity are those in accordance with 5 U.S.C. 552(a) and 1 products that substitute, in accordance CFR Part 51. with § 317.313(d), for a standardized [47 FR 28256, June 29, 1982, as amended at 54 product defined in this part and use the FR 40631, Oct. 3, 1989; 59 FR 33642, June 30, name of that standardized product in 1994; 62 FR 45026, Aug. 25, 1997; 65 FR 34389, their statements of identity, but that May 30, 2000; 69 FR 1874, Jan. 12, 2004] do not comply with the established standard because of a compositional § 319.6 Limitations with respect to use deviation that results from reduction of Mechanically Separated (Spe- of a constituent that is described by an cies). expressed nutrient content claim that (a) Meat food products required to be has been defined by regulation in part prepared from one species shall not 317, subpart B, of this subchapter. The contain Mechanically Separated (Spe- expressed nutrient content claim shall cies) of any other species. comply with the requirements of (b) Mechanically Separated (Species) § 317.313 of this subchapter and with the described in § 319.5 that has a protein requirements of part 317, subpart B, of content of not less than 14 percent and this subchapter which define the par- a fat content of not more than 30 per- ticular nutrient content claim that is cent may constitute up to 20 percent of used. The meat food product shall com- the livestock and poultry product por- ply with the relevant standard in this tion of any meat food product except part in all other respects, except as those listed in paragraph (d) of this provided in paragraphs (b) and (c) of section. this section. (c) Mechanically Separated (Species) (b) Performance characteristics. The for processing described in § 319.5 may performance characteristics, such as constitute up to 20 percent of the live- physical properties, functional prop- stock and poultry product portion of erties, and shelf-life, of the meat food any meat food product that is subject product shall be similar to those of the to a definition and standard of identity standardized meat food product pro- or composition in part 319 which estab- duced under this part. If there is a sig- lishes a maximum limit on the fat con- nificant difference in a performance tent of such meat food product except characteristic that materially limits those listed in paragraph (d) of this the use of the product compared to the section. use of the standardized product defined (d) Mechanically Separated (Species) in this part, the label shall include a and Mechanically Separated (Species) statement in accordance with for processing described in § 319.5 shall § 317.313(d)(1) and (2) of this subchapter not be used in baby, junior, or toddler that informs the consumer of such dif- foods, ground beef, hamburger, fab- ferences (e.g., if appropriate, ‘‘not rec- ricated steaks (§ 319.15 (a), (b), and (d)), ommended for frozen storage’’ or ‘‘not barbecued meats (§ 319.80), roast beef- suitable for roller grilling’’). Devi- parboiled and steam roasted (§ 319.81), ations from the ingredient provisions corned (cured) beef cuts (§§ 319.100– of the standard must be the minimum 319.103), certain cured pork products necessary to qualify for the nutrient (§§ 319.104 (a)–(e) and 319.106), tripe with content claim, while maintaining simi- milk (§ 319.308), lima beans with ham lar performance characteristics. and similar products (§ 319.310), beef (c) Ingredients used in substitute prod- with gravy and gravy with beef ucts. (1) Ingredients used in the product (§ 319.313), and meat pies (§ 319.500). shall be those ingredients provided for [47 FR 28257, June 29, 1982] in the standard as defined in this part,

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except that safe and suitable ingredi- product) or ‘‘**Ingredients in excess of ents permitted for use in meat food amounts permitted in regular llll’’ products as provided in a regulation (the blank shall be filled in with the permitting that use in this subchapter name of the traditional standardized or in 9 CFR Chapter III, Subchapter E, product), or both, as appropriate, shall or in 21 CFR Chapter I, Subchapter A immediately follow the ingredients or Subchapter B, may be used at the statement in the same type and size. minimum level necessary to improve [70 FR 33818, June 10, 2005] texture and prevent syneresis, so that the substitute product is not inferior in performance characteristics from the Subpart B—Raw Meat Products standardized product defined in this part for which it is a substitute. § 319.15 Miscellaneous beef products. (2) An ingredient that is specifically (a) Chopped beef, ground beef. required by the standard prescribed in ‘‘Chopped Beef’’ or ‘‘Ground Beef’’ shall this part shall not be replaced or ex- consist of chopped fresh and/or frozen changed with a similar ingredient from beef with or without seasoning and another source, for example, turnip without the addition of beef fat as chunks shall not replace potatoes in such, shall not contain more than 30 corned beef hash. percent fat, and shall not contain (3) An ingredient that is specifically added water, phosphates, binders, or prohibited from use in any meat food extenders. When beef cheek meat product by this part shall not be added (trimmed beef cheeks) is used in the to the substitute meat food product preparation of chopped or ground beef, under this section. the amount of such cheek meat shall (4) Unless otherwise specified in this be limited to 25 percent; and if in ex- part, a substitute meat food product cess of natural proportions, its pres- must meet all other requirements of ence shall be declared on the label, in the applicable standards of identity or the ingredient statement required by composition. § 317.2 of this subchapter, if any, and (5) Water and fat-replacers (e.g., bind- otherwise contiguous to the name of ers), in combination, may be added to the product. replace fat in accordance with para- (b) Hamburger. ‘‘Hamburger’’ shall graph (c) of this section. consist of chopped fresh and/or frozen (6) Textured vegetable protein may beef with or without the addition of be used by itself or in combination beef fat as such and/or seasoning, shall with other binders and water as a fat not contain more than 30 percent fat, replacer in accordance with paragraph and shall not contain added water, (c) of this section. phosphates, binders, or extenders. Beef (d) Nomenclature. The name of a sub- cheek meat (trimmed beef cheeks) may stitute meat food product that com- be used in the preparation of ham- plies with all parts of this section is burger only in accordance with the the appropriate expressed nutrient con- conditions prescribed in paragraph (a) tent claim and the applicable standard- of this section. ized term. (c) Beef patties. ‘‘Beef Patties’’ shall (e) Label declaration. (1) Each of the consist of chopped fresh and/or frozen ingredients used in the substitute meat beef with or without the addition of food product shall be declared on the beef fat as such and/or seasonings. label as required by this section and Binders or extenders, Mechanically part 317 of this subchapter. Separated (Species) used in accordance (2) Ingredients not provided for, and with § 319.6, and/or partially defatted ingredients used in excess of those lev- beef fatty tissue may be used without els provided for, by the standard as de- added water or with added water only fined in this part, shall be identified as in amounts such that the product char- such with an asterisk in the ingredi- acteristics are essentially that of a ents statement. The statement meat pattie. ‘‘*Ingredients not in regular llll’’ (d) Fabricated steak. Fabricated beef (the blank shall be filled in with the steaks, veal steaks, beef and veal name of the traditional standardized steaks, or veal and beef steaks, and

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similar products, such as those labeled percent of the weight of the fresh ‘‘Beef Steak, Chopped, Shaped, Fro- uncooked meat. zen,’’ ‘‘Minute Steak, Formed, Wafer Sliced, Frozen,’’ ‘‘Veal Steaks, Beef § 319.81 Roast beef parboiled and Added, Chopped—Molded—Cubed—Fro- steam roasted. zen, Hydrolyzed Plant Protein, and ‘‘Roast Beef Parboiled and Steam Flavoring’’ shall be prepared by Roasted’’ shall be prepared so that the comminuting and forming the product weight of the finished product, exclud- from fresh and/or frozen meat, with or ing salt and flavoring material, shall without added fat, of the species indi- not exceed 70 percent of the fresh beef cated on the label. Such products shall weight. Transglutaminase enzyme at not contain more than 30 percent fat levels of up to 65 ppm may be used as and shall not contain added water or a binder in such product. Beef cheek extenders. Transglutaminase enzyme meat and beef head meat from which at levels of up to 65 ppm may be used the overlying glandular and connective as a binder. Beef cheek meat (trimmed tissues have been removed, and beef beef cheeks) may be used in the prepa- heart meat, exclusive of the heart cap ration of fabricated beef steaks only in may be used individually or collec- accordance with the conditions pre- tively to the extent of 5 percent of the scribed in paragraph (a) of this section. meat ingredients in the preparation of (e) Partially defatted beef fatty tissue. canned product labeled ‘‘Roast Beef ‘‘Partially Defatted Beef Fatty Tissue’’ Parboiled and Steam Roasted.’’ When is a beef byproduct derived from the beef cheek meat, beef head meat, or low temperature rendering (not exceed- beef heart meat is used in the prepara- ing 120 °F.) of fresh beef fatty tissue. tion of this product, its presence shall Such product shall have a pinkish color be reflected in the statement of ingre- and a fresh odor and appearance. dients required by part 317 of this subchapter. [35 FR 15597, Oct. 3, 1970, as amended at 38 FR 29215, Oct. 23, 1973; 43 FR 26424, June 20, 1978; [35 FR 15597, Oct. 3, 1970, as amended at 38 FR 47 FR 10784, Mar. 12, 1982; 47 FR 28257, June 29215, Oct. 23, 1973; 66 FR 54916, Oct. 31, 2001] 29, 1982; 66 FR 54916, Oct. 31, 2001]

§ 319.29 Miscellaneous pork products. Subpart D—Cured Meats, Unsmoked and Smoked (a) Partially defatted pork fatty tissue. ‘‘Partially Defatted Pork Fatty Tis- § 319.100 Corned beef. sue’’ is a pork byproduct derived from ‘‘Corned Beef’’ shall be prepared from the low temperature rendering (not ex- beef briskets, navels, clods, middle ceeding 120 °F.) of fresh pork fatty tis- ribs, rounds, rumps, or similar cuts sue, exclusive of skin. Such product using one or a combination of the cur- shall have a pinkish color and a fresh ing ingredients specified in a regula- odor and appearance. tion permitting that use in this subchapter or 9 CFR chapter III, sub- Subpart C—Cooked Meats chapter E, or in 21 CFR chapter I, subchapter A or subchapter B. Canned § 319.80 Barbecued meats. product labeled ‘‘Corned Beef’’ shall be Barbecued meats, such as product la- prepared so that the weight of the fin- beled ‘‘Beef Barbecue’’ or ‘‘Barbecued ished product, excluding cure, salt, and Pork,’’ shall be cooked by the direct flavoring material, shall not exceed 70 action of dry heat resulting from the percent of the fresh beef weight. burning of hard wood or the hot coals Corned beef other than canned shall be therefrom for a sufficient period to as- cured in pieces weighing not less than sume the usual characteristics of a bar- 1 pound, and if cooked, its weight shall becued article, which include the for- not exceed the weight of the fresh mation of a brown crust on the surface uncured beef. Beef cheek meat, beef and the rendering of surface fat. The head meat and beef heart meat may be product may be basted with a sauce used to the extent of 5 percent of the during the cooking process. The weight meat ingredient in preparation of this of barbecued meat shall not exceed 70 product when trimmed as specified in

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§ 319.81. When beef cheek meat, beef age requirements set forth in the fol- head meat, or beef heart meat is used lowing chart: in preparation of this product, its pres- Minimum ence shall be reflected in the statement Type of cured meat PFF Product name and qualifying of ingredients required by part 317 of pork product percent- statements this subchapter. The application of cur- age 1 ing solution to beef cuts, other than Cooked ham, 20.5 (Common and usual). briskets, which are intended for bulk loin 2. corned beef shall not result in an in- 18.5 (Common and usual) with nat- crease in the weight of the finished ural juices. 17.0 (Common and usual) water cured product of more than 10 percent added. over the weight of the fresh uncured <17.0 (Common and usual) and meat. water product—X% of weight is added ingredi- [35 FR 15597, Oct. 3, 1970; 36 FR 11903, June 23, ents. 3 1971, as amended at 38 FR 29215, Oct. 23, 1973; Cooked shoul- 20.0 (Common and usual). 64 FR 72174, Dec. 23, 1999] der, butt, picnic 2. § 319.101 Corned beef brisket. 18.0 (Common and usual) with natural juices. In preparing ‘‘Corned Beef Brisket,’’ 16.5 (Common and usual) water the application of curing solution to added. <16.5 (Common and usual) and the beef brisket shall not result in an water product—X% of increase in the weight of the finished weight is added ingredi- cured product of more than 20 percent ents. 3 over the weight of the fresh uncured Uncooked cured 18.0 Uncooked (common and ham, loin. usual). brisket. If the product is cooked, the <18.0 Uncooked (common and weight of the finished product shall not usual) and water product— exceed the weight of the fresh uncured X% of weight is added in- brisket. gredients. 3 Uncooked cured 17.5 Uncooked (common and shoulder, butt, usual). § 319.102 Corned beef round and other picnic. corned beef cuts. <17.5 Uncooked (common and In preparing ‘‘Corned Beef Round’’ usual) and water product— X% of weight is added in- and other corned beef cuts, except gredients. 3 ‘‘Corned Beef Briskets,’’ the curing so- 1 The minimum meat PFF percentage shall be the minimum lution shall be applied to pieces of beef meat protein which is indigenous to the raw unprocessed pork weighing not less than one pound and expressed as a percent of the non-fat portion of the finished product; and compliance shall be determined under § 318.19 such application shall not result in an of this subchapter for domestic cured pork product and increased weight of the cured beef § 327.23 of this subchapter for imported cured pork product. 2 The term ‘‘cooked’’ is not appropriate for use on labels of product of more than 10 percent over cured pork products heated only for the purpose of destruc- the weight of the fresh uncured beef tion of possible live trichinae. 3 Processors may immediately follow this qualifying state- cut. If the product is cooked, the ment with a list of the ingredients in descending order of pre- weight of the finished product shall not dominance rather than having the traditional ingredients statement. In any case, the maximum percent of added sub- exceed the weight of the fresh uncured stances in the finished product on a total weight percentage beef cut. basis would be inserted as the X value; e.g., Ham and Water Product—20% of Weight is Added Ingredients. § 319.103 Cured beef tongue. (b) Cured pork products for which In preparing ‘‘Cured Beef Tongue,’’ there is a qualifying statement re- the application of curing solution to quired in paragraph (a) of this section the fresh beef tongue shall not result in shall bear that statement as part of the an increase in the weight of the cured product name in lettering not less than beef tongue of more than 10 percent 3⁄8 inch in height, or in lettering not over the weight of the fresh uncured less than one-third the size of the larg- beef tongue. est letter in the product name if it is in the same color and style of print and § 319.104 Cured pork products. on the same color background as the (a) Cured pork products, including product name. However, the Adminis- hams, shoulders, picnics, butts and trator may approve smaller lettering loins, shall comply with the minimum for labeling of packages of 1 pound or meat Protein Fat Free (PFF) percent- less, provided such lettering is at least

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one-third the size and of the same color Type of cured pork Minimum Product name and product meat PFF qualifying statements and style as the product name. percentage 1 (c) Cured pork product prepared pursuant to this section shall be subject to ‘‘Ham Patties,’’ ‘‘Chopped Ham,’’ the compliance procedures in § 318.19 of ‘‘Pressed Ham,’’ this subchapter. and ‘‘Spiced (d) The binders provided for use in Ham’’ ...... 19.5 (Common and usual). ‘‘Ham Patties,’’ cured pork products in a regulation in ‘‘Chopped Ham,’’ this subchapter, in 9 CFR chapter III, ‘‘Pressed Ham,’’ subchapter E, or in 21 CFR chapter I, and ‘‘Spiced Ham’’ ...... 17.5 (Common and usual) subchapter A or subchapter B, may be with natural juices. used singly in those cured pork prod- ‘‘Ham Patties,’’ ucts labeled as ‘‘Ham Water Added,’’ ‘‘Chopped Ham,’’ ‘‘Pressed Ham,’’ ‘‘Ham and Water Product-X% of and ‘‘Spiced Weight is Added Ingredients,’’ and Ham’’ ...... 16.0 (Common and usual) ‘‘Ham with Natural Juices.’’ In addi- water added. tion to the binders referred to in the ‘‘Ham Patties,’’ ‘‘Chopped Ham,’’ preceding sentence, the following sub- ‘‘Pressed Ham,’’ stances are permitted for use as bind- and ‘‘Spiced ers and may be used singly in those Ham’’ ...... <16.0 (Common and usual) and water product—(x)% cured pork products labeled as ‘‘Ham of weight is added Water Added,’’ ‘‘Ham and Water Prod- ingredients. 2 uct-X% of Weight is Added Ingredi- 1 The minimum meat PFF percentage shall be the minimum ents,’’ and ‘‘Ham with Natural Juices’’: meat protein which is indigenous to the raw, unprocessed pork expressed as a percent of the nonfat portion of the fin- pork collagen at up to 3.5% of the prod- ished product; and compliance shall be determined under sec- uct formulation. Unless their use is tion 318.19 of this subchapter. 2 Processors may immediately follow this qualifying state- provided for in a regulation in this sub- ment with a list of the ingredients in descending order of pre- chapter, in 9 CFR chapter III, sub- dominance rather than having the traditional ingredients statement. In any case, the maximum percent of added subchapter E, or in 21 CFR chapter I, substances in the finished product on a total weight percentage chapter A or subchapter B, or in this basis would be inserted as the X value; e.g., Ham and Water Product—20% of Weight is Added Ingredients. paragraph, these binders are not permitted to be used in combination with (b) Cured pork products prepared another such binder listed for use in under this section except ‘‘Ham pat- cured pork products. When any such ties’’ may contain finely chopped ham substance is added to these products, shank meat to the extent of 25 percent the substance shall be declared in the over that normally present in boneless ingredients statement by its common ham. Mechanically Separated (Species) or usual name in order of predomi- Product may be used in accordance nance. with § 319.6. (c) Cured pork product prepared pur- [49 FR 14879, Apr. 13, 1984, as amended at 50 FR 9792, Mar. 12, 1985; 53 FR 5151, Feb. 22, suant to this section shall be subject to 1988; 57 FR 42888, Sept. 17, 1992; 62 FR 45026, the compliance procedures in § 318.19 of Aug. 25, 1997; 63 FR 148, Jan. 5, 1998; 64 FR this subchapter, and those cured pork 27904, May 24, 1999; 65 FR 34389, May 30, 2000; products prepared under this section 66 FR 54916, Oct. 31, 2001] for which there is a qualifying statement required shall comply with the § 319.105 ‘‘Ham patties,’’ ‘‘Chopped requirements of § 319.104(b) of this sub- ham,’’ ‘‘Pressed ham,’’ ‘‘Spiced ham,’’ chapter. and similar products. (d) In addition to the other require- (a) Finely divided (chopped, ground, ments of this section, ‘‘Ham Patties’’ flaked, chipped) cured ham products may not contain more than 35 percent such as ‘‘Ham patties,’’ ‘‘Chopped fat, by analysis. ham,’’ ‘‘Pressed ham,’’ and ‘‘Spiced ham’’ shall comply with minimum [49 FR 14880, Apr. 13, 1984, as amended at 53 meat Protein Fat Free (PFF) percent- FR 5151, Feb. 22, 1988; 62 FR 45026, Aug. 25, age requirements set forth in the fol- 1997; 65 FR 34389, May 30, 2000] lowing chart:

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§ 319.106 ‘‘Country Ham,’’ ‘‘Country or a water activity of not more than Style Ham,’’ ‘‘Dry Cured Ham,’’ 0.92. ‘‘Country Pork Shoulder,’’ ‘‘Country (5) For hams or pork shoulders la- Style Pork Shoulder,’’ and ‘‘Dry beled ‘‘country’’ or ‘‘country style,’’ Cured Pork Shoulder.’’ the combined period for curing and salt (a) ‘‘Country Ham,’’ ‘‘Country Style equalization shall not be less than 45 Ham,’’ or ‘‘Dry Cured Ham,’’ and days for hams, and shall not be less ‘‘Country Pork Shoulder,’’ ‘‘Country than 25 days for pork shoulders; the Style Pork Shoulder,’’ or ‘‘Dry Cured total time for curing salt equalization, Pork Shoulder.’’ are the uncooked, and drying shall not be less than 70 cured, dried, smoked or unsmoked days for hams, and shall not be less meat food products made respectively than 50 days for pork shoulders. During from a single piece of meat conforming the drying and smoking period, the in- to the definition of ‘‘ham,’’ as specified ternal temperature of the product must ° in § 317.8(b)(13) of this subchapter, or not exceed 95 F., provided that such from a single piece of meat from a pork temperature requirement shall not shoulder. They are prepared in accord- apply to product dried or smoked under ance with paragraph (c) of this section natural climatic conditions. (6) For hams or pork shoulders la- by the dry application of salt (NaCl), or beled ‘‘dry cured,’’ the combined period by the dry application of salt (NaCl) for curing and salt equalization shall and one or more of the optional ingre- not be less than 45 days for hams, and dients as specified in paragraph (d) of shall not be less than 25 days for pork this section. They may not be injected shoulders; and the total time for cur- with curing solutions nor placed in curing, salt equalization, and drying shall ing solutions. not be less than 55 days for hams and (b) The product must be treated for shall not be less than 40 days for pork the destruction of possible live shoulders. trichinae in accordance with such (7) The weight of the finished hams methods as may be approved by the Ad- and pork shoulders covered in this sec- ministrator upon request in specific in- tion shall be at least 18 percent less stances and none of the provisions of than the fresh uncured weight of the this standard can be interpreted as dis- article. charging trichinae treatment require- (d) The optional ingredients for prod- ments. ucts covered in this section are: (c)(1) The entire exterior of the ham (1) Nutritive sweeteners, spices, or pork shoulder shall be coated by the seasonings and flavorings. dry application of salt or by the dry ap- (2) Sodium or potassium nitrate and plication of salt combined with other sodium or potassium nitrite if used as ingredients as permitted in paragraph prescribed in this section and in ac- (d) of this section. cordance with a regulation permitting (2) Additional salt, or salt mixed with that use in this subchapter or 9 CFR other permitted ingredients, may be re- Chapter III, Subchapter E, or in 21 CFR applied to the product as necessary to Chapter I, Subchapter A or Subchapter insure complete penetration. B. (3) When sodium or potassium ni- [42 FR 3299, Jan. 18, 1977, as amended at 64 trate, or sodium or potassium nitrite, FR 72174, Dec. 23, 1999] or a combination thereof, is used, the EFFECTIVE DATE NOTE: At 46 FR 1257, Jan. application of salt shall be in sufficient 6, 1981, the Safety and Quality Service, De- quantity to insure that the finished partment of Agriculture, announced that product has an internal salt content of ‘‘the temperature and time period provisions at least 4 percent. of 9 CFR 319.106, paragraphs (c)(5) and (c)(6), (4) When no sodium nitrate, potas- have not been in effect since November 17, sium nitrate, sodium nitrite, potas- 1980, and will not be enforced pending future sium nitrite or a combination thereof Agency action in the matter. However, ham and pork shoulders must continue to be pre- is used, the application of salt shall be pared in compliance with all other provi- in sufficient quantity to insure that sions of 9 CFR 319.106 in order to be labeled the finished product has a brine con- ‘country ham,’ ‘country style ham,’ or ‘dry centration of not less than 10 percent cured ham,’ and ‘country pork shoulder,’

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‘country style pork shoulder,’ or ‘dry cured may contain no more than 10 percent pork shoulder.’ ’’ of added water in the finished product. Sausage may contain Mechanically § 319.107 Bacon. Separated (Species) used in accordance The weight of cured pork bellies with § 319.6. ready for slicing and labeling as [55 FR 34683, Aug. 24, 1990, as amended at 64 ‘‘Bacon’’ shall not exceed the weight of FR 72175, Dec. 23, 1999; 66 FR 54916, Oct. 31, the fresh uncured pork bellies. 2001] [49 FR 14880, Apr. 13, 1984] § 319.141 Fresh pork sausage. Subpart E—Sausage Generally: ‘‘Fresh Pork Sausage’’ is sausage prepared with fresh pork or frozen pork or Fresh Sausage both, but not including pork byprod- § 319.140 Sausage. ucts, and may contain Mechanically Separated (Species) in accordance with Except as otherwise provided in this § 319.6, and may be seasoned with section, or under the Poultry Products condimental substances as permitted Inspection Act with respect to products under part 318 of this subchapter. The consisting partly of poultry, sausage is finished product shall not contain more the coarse or finely comminuted meat than 50 percent fat. To facilitate chop- food product prepared from one or ping or mixing, water or ice may be more kinds of meat or meat and meat used in an amount not to exceed 3 per- byproducts, containing various cent of the total ingredients used. amounts of water as provided for elsewhere in this part, and usually sea- [35 FR 15597, Oct. 3, 1970, as amended at 43 FR soned with condimented proportions of 26424, June 20, 1978; 47 FR 28257, 28258, June 29, 1982] condimental substances, and frequently cured. Certain sausage as pro- § 319.142 Fresh beef sausage. vided for elsewhere in this part may contain binders and extenders as pro- ‘‘Fresh Beef Sausage’’ is sausage pre- vided in a regulation permitting that pared with fresh beef or frozen beef, or use in this subchapter or in 9 CFR both, but not including beef byprod- chapter III, subchapter E, or in 21 CFR ucts, and may contain Mechanically chapter I, subchapter A or subchapter Separated (Species) used in accordance B. In addition to the binders and ex- with § 319.6, and may be seasoned with tenders referred to in the preceding condimental substances as permitted sentence, the following two substances under part 318 of this subchapter. The may also be used as binders in those finished product shall not contain more sausages in which the use of such class than 30 percent fat. To facilitate chop- of substances is permitted: pork col- ping or mixing, water or ice may be lagen at up to 3.5% of the product for- used in an amount not to exceed 3 per- mulation and transglutaminase en- cent of the total ingredients used. zyme at up to 65 ppm of the product [35 FR 15597, Oct. 3, 1970, as amended at 43 FR formulation. Sausage may not contain 26424, June 20, 1978; 47 FR 28257, June 29, 1982] phosphates except that phosphates listed in a regulation permitting that use § 319.143 Breakfast sausage. in this subchapter or in 9 CFR chapter ‘‘Breakfast sausage’’ is sausage pre- III, subchapter E, or in 21 CFR chapter pared with fresh and/or frozen meat; or I, subchapter A or subchapter B may be fresh and/or frozen meat and meat by- used in cooked sausage. To facilitate products, and may contain Mechani- chopping or mixing or to dissolve the cally Separated (Species) in accordance usual curing ingredients, water or ice with § 319.6, and may be seasoned with may be used in the preparation of sau- condimental substances as permitted sage which is not cooked in an amount in part 318 of this subchapter. The fin- not to exceed 3 percent of the total in- ished product shall not contain more gredients in the formula. Cooked sau- than 50 percent fat. To facilitate chop- sages such as Polish sausage, cotto sa- ping or mixing, water or ice may be lami, braunschweiger, liver sausage, used in an amount not to exceed 3 per- and similar cooked sausage products cent of the total ingredients used.

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Binders or extenders may be added as trichinae in accordance with § 318.10 of provided in § 319.140 of this part. this subchapter. (3) ‘‘Italian Beef Sausage’’ or ‘‘Kosher [55 FR 34683, Aug. 24, 1990, as amended at 66 FR 54916, Oct. 31, 2001] Italian Beef Sausage’’ shall be prepared with fresh or frozen beef or beef and § 319.144 Whole hog sausage. beef fat. ‘‘Italian Veal Sausage’’ or ‘‘Kosher Italian Veal Sausage’’ shall be ‘‘Whole Hog Sausage’’ is sausage pre- prepared with fresh or frozen veal or pared with fresh and/or frozen meat veal and veal fat. Mechanically Sepa- from swine in such proportions as are rated (Species) may be used in accord- normal to a single animal, and may in- ance with § 319.6. clude any Mechanically Separated (4) Italian sausage products made in (Species) produced from the animal and conformance with the provisions of used in accordance with § 319.6, and paragraphs (a) (1), (2), and (3) of this may be seasoned with condimental subsection, and with paragraphs (b) and (c) stances as permitted under part 318 of of this section, may contain sodium ni- this subchapter. The finished product trite or potassium nitrite in amounts shall not contain more than 50 percent not to exceed those allowed in a regula- fat. To facilitate chopping or mixing, tion permitting that use in this sub- water or ice may be used in an amount chapter or in 9 CFR chapter III, sub- not to exceed 3 percent of the total in- chapter E, or in 21 CFR chapter I, sub- gredients used. chapter A or subchapter B, provided [35 FR 15597, Oct. 3, 1970, as amended at 43 FR that such products are labeled with the 26424, June 20, 1978; 47 FR 28257, 28258, June word ‘‘cured’’ in the product name, 29, 1982] such as ‘‘Cured Italian Sausage.’’ The word ‘‘cured’’ shall be displayed on the § 319.145 Italian sausage products. product label in the same size and style (a) Italian sausage products are cured of lettering as other words in the prod- or uncured sausages containing at least uct name. 85 percent meat, or combination of (b) Optional ingredients permitted in meat and fat, with the total fat con- Italian sausage products include: tent constituting not more than 35 per- (1) Spices (including paprika) and cent of the finished product. Such prod- flavorings. ucts shall be prepared in accordance (2) Water or ice to facilitate chopping with the provisions of paragraph (a) (1), or mixing, but not to exceed 3 percent (2) or (3) of this section, and shall con- of the total weight of all ingredients tain salt, pepper, and either fennel or including the water. anise, or a combination of fennel and (3) Red or green peppers, or both. anise. Such products may contain any (4) Dehydrated or fresh onions, gar- or all of the optional ingredients listed lic, and parsley. in paragraph (b) of this section. (5) Sugar, dextrose, corn syrup, corn (1) ‘‘Italian Sausage’’ shall be pre- syrup solids, and glucose syrup. pared with fresh or frozen pork, or pork (6) Monosodium glutamate and anti- and pork fat, and may contain Me- oxidants in accordance with the chart chanically Separated (Species) in ac- of substances a regulation permitting cordance with § 319.6. that use in this subchapter or in 9 CFR (2) ‘‘Italian Sausage with Beef,’’ chapter III, subchapter E, or in 21 CFR ‘‘Italian Sausage with Veal,’’ or chapter I, subchapter A or subchapter ‘‘Italian Sausage with Beef and Veal,’’ B. shall be prepared so that fresh or fro- (c) If Italian sausage products are zen pork constitutes the major portion cooked or smoked, determination of of the meat content requirement of compliance with the provisions of para- this paragraph. Mechanically Sepa- graphs (a) and (b) of this section shall rated (Species) may be used in accord- be based on the uncooked or unsmoked ance with § 319.6. When pork muscle tis- product. The product before cooking or sue is combined with beef or veal, or smoking shall contain no more than 3 both, in the preparation of bulk-packed percent water as specified in paragraph products, or patties, it shall be treated (b)(2) of this section. Product which is for the destruction of possible live cooked shall be labeled with the word

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‘‘cooked’’ in the product name, such as solve the curing ingredients but the ‘‘Cooked Italian Sausage’’ or ‘‘Cooked sausage shall contain no more than 40 Cured Italian Sausage.’’ Product which percent of a combination of fat and is smoked shall be labeled with the added water. These sausage products word ‘‘smoked’’ in the product name, may contain only phosphates approved such as ‘‘Smoked Italian Sausage’’ or under part 318 of this chapter. Such ‘‘Smoked Cured Italian Sausage.’’ The products may contain raw or cooked words ‘‘cooked’’ and ‘‘smoked’’ shall be poultry meat and/or Mechanically Sep- displayed on the product label in the arated (Kind of Poultry) without skin same size and style of lettering as and without kidneys and sex glands other words in the product name. used in accordance with § 381.174, not in excess of 15 percent of the total ingre- [41 FR 2630, Jan. 19, 1976, as amended at 43 FR 26424, June 20, 1978; 47 FR 28257, 28258, dients, excluding water, in the sausage, June 29, 1982; 49 FR 46533, Nov. 27, 1984; 64 FR and Mechanically Separated (Species) 72175, Dec. 23, 1999] used in accordance with § 319.6. Such poultry meat ingredients shall be des- Subpart F—Uncooked, Smoked ignated in the ingredient statement on the label of such sausage in accordance Sausage with the provisions of § 381.118 of this § 319.160 Smoked pork sausage. chapter. (b) Frankfurter, frank, furter, hot- ‘‘Smoked Pork Sausage’’ is pork sau- dog, wiener, vienna, bologna, garlic bo- sage that is smoked with hardwood or logna, knockwurst and similar cooked other approved nonresinous materials. sausages that are labeled with the It may be seasoned with condimental phrase ‘‘with byproducts’’ or ‘‘with va- substances as permitted in part 318 of riety meats’’ in the product name are this subchapter. The finished product comminuted, semisolid sausages con- shall not contain more than 50 percent sisting of not less than 15 percent of fat. To facilitate chopping or mixing, one or more kinds of raw skeletal mus- water, or ice may be used in an amount cle meat with raw meat byproducts, or not to exceed 3 percent of the total in- not less than 15 percent of one or more gredients used. kinds of raw skeletal muscle meat with [35 FR 15597, Oct. 3, 1970, as amended at 47 FR raw meat byproducts and raw or 28258, June 29, 1982] cooked poultry products; and seasoned and cured, using one or more of the Subpart G—Cooked Sausage curing ingredients in accordance with a regulation permitting that use in this § 319.180 Frankfurter, frank, furter, subchapter or in 9 CFR chapter III, hotdog, weiner, vienna, bologna, subchapter E, or in 21 CFR chapter I, garlic bologna, knockwurst, and subchapter A or subchapter B. They similar products. may or may not be smoked. Partially (a) Frankfurter, frank, furter, hot- defatted pork fatty tissue or partially dog, wiener, vienna, bologna, garlic bo- defatted beef fatty tissue, or a com- logna, knockwurst and similar cooked bination of both, may be used in an sausages are comminuted, semisolid amount not exceeding 15 percent of the sausages prepared from one or more meat and meat byproducts or meat, kinds of raw skeletal muscle meat or meat byproducts, and poultry products raw skeletal muscle meat and raw or ingredients. The finished products shall cooked poultry meat, and seasoned and not contain more than 30 percent fat. cured, using one or more of the curing Water or ice, or both, may be used to agents in accordance with a regulation facilitate chopping or mixing to dis- permitting that use in this subchapter solve the curing and seasoning ingredi- or in 9 CFR chapter III, subchapter E, ents, the sausage shall contain no more or in 21 CFR chapter I, subchapter A or than 40 percent of a combination of fat subchapter B. They may or may not be and added water. These sausage prod- smoked. The finished products shall ucts may contain only phosphates ap- not contain more than 30 percent fat. proved under part 318 of this chapter. Water or ice, or both, may be used to These sausage products may contain facilitate chopping or mixing or to dis- poultry products and/or Mechanically

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Separated (Kind of Poultry) used in ac- be declared in the ingredients state- cordance with § 381.174, individually or ment by its common or usual name in in combination, not in excess of 15 per- order of predominance. cent of the total ingredients, excluding (f) Cooked sausages shall not be la- water, in the sausage, and may contain beled with terms such as ‘‘All Meat’’ or Mechanically Separated (Species) used ‘‘All (Species),’’ or otherwise to indi- in accordance with § 319.6. Such poultry cate they do not contain nonmeat in- products shall not contain kidneys or gredients or are prepared only from sex glands. The amount of poultry skin meat. present in the sausage must not exceed (g) For the purposes of this section: the natural proportion of skin present Poultry meat means deboned chicken on the whole carcass of the kind of meat or turkey meat, or both, without poultry used in the sausage, as speci- skin or added fat; poultry products fied in § 381.117(d) of this chapter. The mean chicken or turkey, or chicken poultry products used in the sausage meat or turkey meat as defined in shall be designated in the ingredient § 381.118 of this chapter, or poultry by- statement on the label of such sausage products as defined in § 381.1 of this in accordance with the provisions of chapter; and meat byproducts (or vari- § 381.118 of this chapter. Meat byprod- ety meats), mean pork stomachs or ucts used in the sausage shall be des- snouts; beef, veal, lamb, or goat tripe; ignated individually in the ingredient statement on the label for such sausage beef, veal, lamb, goat, or pork hearts, in accordance with § 317.2 of this chap- tongues, fat, lips, weasands, and ter. spleens; and partially defatted pork (c) A cooked sausage as defined in fatty tissue, or partially defatted beef paragraph (a) of this section shall be fatty tissue. labeled by its generic name, e.g., frank- [38 FR 14742, June 5, 1973] furter, frank, furter, hotdog, wiener, vienna, bologna, garlic bologna, or EDITORIAL NOTE: For FEDERAL REGISTER ci- knockwurst. When such sausage prod- tations affecting § 319.180, see the List of CFR Sections Affected, which appears in the ucts are prepared with meat from a sin- Finding Aids section of the printed volume gle species of cattle, sheep, swine, or and at www.fdsys.gov. goats they shall be labeled with the term designating the particular species § 319.181 Cheesefurters and similar in conjunction with the generic name, products. e.g., ‘‘Beef Frankfurter,’’ and when ‘‘Cheesefurters’’ and similar products such sausage products are prepared in are products in casings which resemble part with Mechanically Separated frankfurters except that they contain (Species) in accordance with § 319.6, sufficient cheese to give definite char- they shall be labeled in accordance acteristics to the finished article. They with § 317.2(j)(13) of this subchapter. may contain binders and extenders as (d) A cooked sausage as defined in provided in § 424.21(c) of subchapter E. paragraph (b) of this section shall be Limits on use as provided in § 424.21 are labeled by its generic name, e.g., frank- intended to be exclusive of the cheese furter, frank, furter, hotdog, wiener, constituent. When any such substance vienna, bologna, garlic bologna, or knockwurst, in conjunction with the is added to these products, the sub- phrase ‘‘with byproducts’’ or ‘‘with va- stance shall be designated in the ingre- riety meats’’ with such supplemental dients statement by its common or phrase shown in a prominent manner usual name in order of predominance. directly contiguous to the generic These products shall contain no more name and in the same color on an iden- than 40 percent of a combination of fat tical background. and added water, and no more than 30 (e) Binders and extenders as provided percent fat and shall comply with the in § 319.140 of this part may be used in other provisions for cooked sausages cooked sausage that otherwise comply that are in this subchapter. with paragraph (a) or (b) of this sec- [55 FR 34683, Aug. 24, 1990, as amended at 56 tion. When any such substance is added FR 41448, Aug. 21, 1991; 76 FR 82078, Dec. 30, to these products, the substance shall 2011]

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§ 319.182 Braunschweiger and liver rated (Species) may be used in accord- sausage or liverwurst. ance with § 319.6. To facilitate chopping (a) ‘‘Braunschweiger’’ is a cooked or mixing or to dissolve the usual cur- sausage made from fresh, cured, and/or ing ingredients, water or ice may be frozen pork, beef, and/or veal and at used in the preparation of luncheon least 30 percent pork, beef, and/or veal meat in an amount not to exceed 3 per- livers computed on the weight of the cent of the total ingredients. fresh livers. It may also contain pork [35 FR 15597, Oct. 3, 1970, as amended at 43 FR and/or beef fat. Mechanically Sepa- 26425, June 20, 1978; 47 FR 28257, June 29, 1982] rated (Species) may be used in accordance with § 319.6. Binders and extenders § 319.261 Meat loaf. may be used as permitted in § 319.140. ‘‘Meat Loaf’’ is a cooked meat food The product may have a smoked taste product in loaf form made from characteristic, which may be imparted comminuted meat. Mechanically Sepa- by use of smoked meats, smoke fla- rated (Species) may be used in accord- voring or smoking. If prepared from ance with § 319.6. To facilitate chopping components of a single species, the or mixing, water or ice may be used in product name may reflect the species, an amount not to exceed 3 percent of e.g., ‘‘Beef Braunschweiger.’’ Braun- the total ingredients used. schweiger may also be labeled as any of [35 FR 15597, Oct. 3, 1970, as amended at 43 FR the following: ‘‘Braunschweiger—A 26425, June 20, 1978; 47 FR 28257, June 29, 1982] Liver Sausage,’’ ‘‘Braunschweiger—A Liverwurst,’’ or ‘‘Braunschweiger Subpart L—Meat Specialties, (Liver Sausage)’’ or ‘‘Braunschweiger (Liverwurst).’’ Puddings and Nonspecific Loaves (b) ‘‘Liver Sausage’’ or ‘‘Liverwurst’’ § 319.280 Scrapple. is a cooked sausage made from fresh, cured, and/or frozen pork, beef, and/or ‘‘Scrapple’’ shall contain not less veal and at least 30 percent pork, beef, than 40 percent meat and/or meat by- veal, sheep, and/or goat livers com- products computed on the basis of the fresh weight, exclusive of bone. Me- puted on the weight of the fresh livers. chanically Separated (Species) may be It may also contain pork and/or beef used in accordance with § 319.6. The byproducts. Mechanically Separated meal or flour used may be derived from (Species) may be used in accordance grain and/or soybeans. with § 319.6. Binders and extenders maybe used as permitted in § 319.140. If [35 FR 15597, Oct. 3, 1970, as amended at 43 FR prepared from components of a single 26425, June 20, 1978; 47 FR 28257, June 29, 1982] species, the product name may reflect that species, e.g., ‘‘Pork Liver Sau- § 319.281 Bockwurst. sage.’’ (a) Bockwurst is an uncured, comminuted meat food product which [47 FR 36108, Aug. 19, 1982] may or may not be cooked. It contains meat, milk or water or a combination Subpart H [Reserved] thereof, eggs, vegetables, and any of the optional ingredients listed in para- Subpart I—Semi-Dry Fermented graph (b) of this section; and is pre- Sausage [Reserved] pared in accordance with the provisions of paragraphs (a)(1), (2), (3), and Subpart J—Dry Fermented (4) of this section. (1) Meat shall constitute not less Sausage [Reserved] than 70 percent of the total weight of the product and shall consist of pork or Subpart K—Luncheon Meat, a mixture of pork and veal, pork and Loaves and Jellied Products beef, or pork, veal, and beef. Such meat shall be fresh or fresh frozen meat. § 319.260 Luncheon meat. Pork may be omitted when the specie ‘‘Luncheon Meat’’ is a cured, cooked or species of meat used in the product meat food product made from is identified in the product name (e.g., comminuted meat. Mechanically Sepa- Veal Bockwurst, Beef Bockwurst, or

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Beef and Veal Bockwurst). Mechani- on the weight of the fresh meat. Me- cally Separated (Species) may be used chanically Separated (Species) may be in accordance with § 319.6. used in accordance with § 319.6. Head (2) The ‘‘milk’’ may be fresh whole meat, cheek meat, and heart meat ex- milk, dried milk, nonfat dry milk, cal- clusive of the heart cap may be used to cium reduced dried skim milk, enzyme the extent of 25 percent of the meat in- (rennet) treated calcium reduced dried gredients under specific declaration on skim milk and calcium lactate, or any the label. The mixture may contain combination thereof. binders and extenders as provided in (3) ‘‘Eggs’’ refer to whole eggs that § 424.21(c) of subchapter E. are fresh, frozen, or dried. [55 FR 34684, Aug. 24, 1990, as amended at 76 (4) ‘‘Vegetables’’ refer to onions, FR 82078, Dec. 30, 2011] chives, parsley, and leeks, alone or in any combination. § 319.301 Chili con carne with beans. (b) Bockwurst may contain one or Chili con carne with beans shall con- more of the following optional ingredi- tain not less than 25 percent of meat ents: computed on the weight of the fresh (1) Pork fat. meat. Mechanically Separated (Spe- (2) Celery, fresh or dehydrated. cies) may be used in accordance with (3) Spices, flavorings. § 319.6. Head meat, cheek meat, or heart (4) Salt. meat exclusive of the heart cap may be (5) Egg whites, fresh, frozen, or dried. used to the extent of 25 percent of the (6) Corn syrup solids, corn syrup, or meat ingredients, and its presence glucose syrup with a maximum limit of shall be reflected in the statement of 2 percent individually or collectively, ingredients required by part 317 of this calculated on a dry basis. The max- subchapter. The mixture may contain imum quantities of such ingredients binders and extenders as provided in shall be computed on the basis of the § 424.21(c) of subchapter E. total weight of the ingredients. (7) Autolyzed yeast extract, [55 FR 34684, Aug. 24, 1990, as amended at 76 hydrolyzed plant protein, milk protein FR 82078, Dec. 30, 2011] hydrolysate, and monosodium glutamate. § 319.302 Hash. (8) Sugars (sucrose and dextrose). ‘‘Hash’’ shall contain not less than 35 (9) Binders and extenders may be percent of meat computed on the added as provided in § 424.21(c) of sub- weight of the cooked and trimmed chapter E. When any such substance is meat. The weight of the cooked meat added to bockwurst, the substance used in this calculation shall not ex- shall be designated in the ingredients ceed 70 percent of the weight of the statement by its common or usual uncooked fresh meat. Mechanically name in order of predominance. Separated (Species) may be used in ac- (c) If bockwurst is cooked or par- cordance with § 319.6. tially cooked, the composition of the [35 FR 15597, Oct. 3, 1970, as amended at 43 FR raw mix from which it is prepared shall 26425, June 20, 1978; 47 FR 28257, June 29, 1982] be used in determining whether it meets the requirements of this section. § 319.303 Corned beef hash. [40 FR 18542, Apr. 29, 1975, as amended at 41 (a) ‘‘Corned Beef Hash’’ is the semi- FR 18089, Apr. 30, 1976; 43 FR 26425, June 20, solid food product in the form of a com- 1978; 45 FR 10318, Feb. 15, 1980; 47 FR 26374, pact mass which is prepared with beef, June 18, 1982; 47 FR 28257, 28258, June 29, 1982; potatoes, curing agents, seasonings, 55 FR 34683, Aug. 24, 1990; 56 FR 41448, Aug. and any of the optional ingredients 21, 1991; 76 FR 82078, Dec. 30, 2011] listed in paragraph (b) of this section, in accordance with the provisions of Subpart M—Canned, Frozen, or paragraphs (a) (1), (2), (3) and (4) of this Dehydrated Meat Food Products section and the provisions of paragraph (c) of this section. § 319.300 Chili con carne. (1) Either fresh beef, cured beef, or ‘‘Chili con carne’’ shall contain not canned corned beef or a mixture of two less than 40 percent of meat computed or more of these ingredients, may be

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used, and the finished product shall ingredient,’’ or ‘‘Beef head meat con- contain not less than 35 percent of beef stitutes 5 percent of the meat ingre- computed on the weight of the cooked dient,’’ or ‘‘Beef heart meat constitutes and trimmed beef. The weight of the 5 percent of the meat ingredient.’’ cooked meat used in this calculation When two or more of the ingredients shall not exceed 70 percent of the are used, the words ‘‘Constitutes 5 per- weight of the uncooked fresh meat. cent of meat ingredient’’ need only ap- (2) ‘‘Potatoes’’ refers to fresh pota- pear once. toes, dehydrated potatoes, cooked de- (2) Whenever the words ‘‘corned beef hydrated potatoes, or a mixture of two hash’’ are featured on the label so con- or more of these ingredients. spicuously as to identify the contents, (3) The curing agents that may be the statements prescribed in paragraph used are salt, sodium nitrate, sodium nitrite, potassium nitrate, or potas- (d)(1) of this section shall immediately sium nitrite, or a combination of two and conspicuously precede or follow or more of these ingredients. When so- such name without intervening writ- dium nitrate, or sodium nitrite, potas- ten, printed, or other graphic matter. sium nitrate, or potassium nitrite is [35 FR 15597, Oct. 3, 1970, as amended at 43 FR used it shall be used in amounts not ex- 26425, June 20, 1978; 47 FR 28257, June 29, 1982; ceeding those specified in a regulation 64 FR 72175, Dec. 23, 1999] permitting that use in this subchapter or in 9 CFR Chapter III, Subchapter E, § 319.304 Meat stews. or in 21 CFR Chapter I, Subchapter A Meat stews such as ‘‘Beef Stew’’ or or Subchapter B. ‘‘Lamb Stew’’ shall contain not less (4) The seasonings that may be used, than 25 percent of meat of the species singly or in combination, are salt, named on the label, computed on the sugar (sucrose or dextrose), spice, and flavoring, including essential oils, weight of the fresh meat. Mechanically oleoresins, and other spice extractives. Separated (Species) may be used in ac- (b) Corned beef hash may contain one cordance with § 319.6. or more of the following optional in- [35 FR 15597, Oct. 3, 1970, as amended at 43 FR gredients: 26425, June 20, 1978; 47 FR 28257, June 29, 1982] (1) Beef cheek meat and beef head meat from which the overlying glan- § 319.305 Tamales. dular and connective tissues have been ‘‘Tamales’’ shall be prepared with at removed, and beef heart meat, exclu- least 25 percent meat computed on the sive of the heart cap, may be used indi- weight of the uncooked fresh meat in vidually or collectively to the extent of relation to all ingredients of the 5 percent of the meat ingredients; (2) Onions, including fresh onions, de- tamales. When tamales are packed in hydrated onions, or onion powder; sauce or gravy, the name of the prod- (3) Garlic, including fresh garlic, de- uct shall include a prominent reference hydrated garlic, or garlic powder; to the sauce or gravy; for example, (4) Water; ‘‘Tamales With Sauce’’ or ‘‘Tamales (5) Beef broth or beef stock; With Gravy.’’ Product labeled (6) Monosodium glutamate; ‘‘Tamales With Sauce’’ or ‘‘Tamales (7) Hydrolyzed plant protein; With Gravy’’ shall contain not less (8) Beef fat; than 20 percent meat, computed on the (9) Mechanically Separated (Species) weight of the uncooked fresh meat in when derived from carcasses of cattle relation to the total ingredients mak- may be used in accordance with § 319.6. ing up the tamales and sauce or the (c) The finished product shall not tamales and gravy. Mechanically Sepa- contain more than 15 percent fat nor rated (Species) may be used in accord- more than 72 percent moisture. ance with § 319.6. (d)(1) When any ingredient specified in paragraph (b)(1) of this section is [35 FR 15597, Oct. 3, 1970, as amended at 43 FR used, the label shall bear the following 26425, June 20, 1978; 47 FR 28257, 28258, June applicable statement: ‘‘Beef cheek 29, 1982] meat constitutes 5 percent of the meat

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§ 319.306 Spaghetti with meatballs and with Bacon in Sauce,’’ and similar sauce, spaghetti with meat and products shall contain not less than 12 sauce, and similar products. percent ham or bacon computed on the ‘‘Spaghetti with Meatballs and weight of the smoked ham or bacon Sauce’’ and ‘‘Spaghetti with Meat and prior to its inclusion with the beans Sauce,’’ and similar products shall con- and sauce. tain not less than 12 percent of meat computed on the weight of the fresh § 319.311 Chow mein vegetables with meat. Mechanically Separated (Spe- meat, and chop suey vegetables cies) may be used in accordance with with meat. § 319.6. The presence of the sauce or ‘‘Chow Mein Vegetables with Meat’’ gravy constituent shall be declared and ‘‘Chop Suey Vegetables with Meat’’ prominently on the label as part of the shall contain not less than 12 percent name of the product. Meatballs may be meat computed on the weight of the prepared with farinaceous material and uncooked fresh meat prior to its inclu- with other binders and extenders as sion with the other ingredients. Me- provided in § 424.21(c) of subchapter E. chanically Separated (Species) may be [55 FR 34684, Aug. 24, 1990, as amended at 76 used in accordance with § 319.6. FR 82078, Dec. 30, 2011] [35 FR 15597, Oct. 3, 1970; 36 FR 11903, June 23, 1971, as amended at 43 FR 26425, June 20, 1978; § 319.307 Spaghetti sauce with meat. 47 FR 28257, June 29, 1982] ‘‘Spaghetti Sauce with Meat’’ shall contain not less than 6 percent of meat § 319.312 Pork with barbecue sauce computed on the weight of the fresh and beef with barbecue sauce. meat. Mechanically Separated (Spe- ‘‘Pork with Barbecue Sauce’’ and cies) may be used in accordance with ‘‘Beef with Barbecue Sauce’’ shall con- § 319.6. sist of not less than 50 percent cooked [35 FR 15597, Oct. 3, 1970, as amended at 43 FR meat of the species specified on the 26425, June 20, 1978; 47 FR 28257, June 29, 1982] label. Mechanically Separated (Pork) may be used in accordance with § 319.6. § 319.308 Tripe with milk. ‘‘Tripe with Milk’’ shall be prepared [69 FR 34916, June 23, 2004] so that the finished canned article, ex- § 319.313 Beef with gravy and gravy clusive of the cooked-out juices and with beef. milk, will contain at least 65 percent tripe. The product shall be prepared ‘‘Beef with Gravy’’ and ‘‘Gravy with with not less than 10 percent milk. Beef’’ shall not be made with beef which, in the aggregate for each lot § 319.309 Beans with frankfurters in contains more than 30 percent sauce, sauerkraut with wieners and trimmable fat, that is, fat which can be juice, and similar products. removed by thorough, practicable trim- ‘‘Beans with Frankfurters in Sauce,’’ ming and sorting. ‘‘Sauerkraut with Wieners and Juice,’’ and similar products shall contain not Subpart N—Meat Food Entree less than 20 percent frankfurters or Products, Pies, and Turnovers wieners computed on the weight of the smoked and cooked sausage prior to its § 319.500 Meat pies. inclusion with the beans or sauerkraut. Meat pies such as ‘‘Beef Pie,’’ ‘‘Veal § 319.310 Lima beans with ham in Pie,’’ and ‘‘Pork Pie’’ shall contain sauce, beans with ham in sauce, meat of the species specified on the beans with bacon in sauce, and label, in an amount not less than 25 similar products. percent of all ingredients including ‘‘Lima Beans with Ham in Sauce,’’ crust and shall be computed on the ‘‘Beans with Ham in Sauce,’’ ‘‘Beans basis of the fresh uncooked meat.

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Subpart O—Meat Snacks, Hors nents, casein, or caseinate; or other d’Oeuvres, Pizza, and Spe- suitable edible protein, including albu- cialty Items min, vegetable proteins, or soy protein isolate; or any mixture of two or more § 319.600 [Reserved] of the articles designated in this subparagraph, in amounts not greater Subpart P—Fats, Oils, Shortenings than reasonably required to accomplish the desired effect. § 319.700 Margarine or oleo- (ii) The articles designated in this margarine. 1 subparagraph shall be pasteurized and (a) Margarine or oleomargarine is the then may be subjected to the action of food in plastic form or liquid emulsion, harmless bacterial starters. One or containing not less than 80 percent fat more of the articles designated in this determined by the method prescribed subparagraph is intimately mixed with under § 938.06 (Chapter 33) of the ‘‘Indi- the edible fat or oil ingredients, or rect Methods’’ in ‘‘Official Methods of both, to form a solidified or liquid Analysis of the Association of Official emulsion. Analytical Chemists’’, 15th edition, (3) Vitamin A in such quantity that 1990. 2 The ‘‘Official Methods of Anal- the finished margarine or oleo- ysis of the Association of Official Ana- margarine contains not less than 15,000 lytical Chemists,’’ 15th edition, 1990, is International Units (IU) of ViTamin A incorporated by reference with the ap- per pound or 33,000 IU per kilogram. proval of the Director of the Federal (b)(1) Vitamin D in such quantity Register in accordance with 5 U.S.C. that the finished margarine or oleo- 552(a) and 1 CFR part 51. It is produced margarine contains not less than 1,500 from one or more of the ingredients IU of Vitamin D per pound or 3,300 IU designated in paragraph (a)(1) of this per kilogram. section, and one or more of the ingredi- (2) Salt (sodium chloride); or potas- ents designated in paragraph (a)(2) of sium chloride for dietary margarine or this section, to which may be added oleomargarine. one or more of the optional ingredients (3) Nutritive carbohydrate sweet- designated in paragraph (b) of this sec- eners. tion. Margarine or oleomargarine con- (4) Emulsifiers identified in a regula- tains Vitamin A as provided for in tion permitting that use in this subparagraph (a)(3) of this section. chapter or a regulation permitting that (1) Edible fats and oils or mixtures of use in this subchapter or in 9 CFR these, whose origin is vegetable or ren- Chapter III, Subchapter E, or in 21 CFR dered animal fats from cattle, sheep, Chapter I, Subchapter A or Subchapter swine or goats. B, within these maximum amounts in (2)(i) Water; milk; milk products in- percent by weight of the finished food: cluding, but not limited to, the liquid, Mono- and diglycerides of fatty acids condensed, or dry form of whey, re- esterified with any or all of the fol- duced lactose whey, reduced minerals lowing acids: acetic, acetyltartaric, whey, or whey protein concentrate, citric, lactic, tartaric, and their so- non-lactose-containing whey compo- dium and calcium salts, 0.5 percent; such mono- and diglycerides in combination with the sodium sulfoacetate 1 Insofar as the standard contains provisions relating to margarine or oleomargarine derivatives thereof, 0.5 percent; which does not contain any meat food prod- polyglycerol esters of fatty acids, 0.5 ucts, such provisions merely reflect the ap- percent; 1,2-propylene glycol esters of plicable standard under the Federal Food, fatty acids, 2 percent; lecithin, 0.5 per- Drug, and Cosmetic Act. cent. 2 A copy of the ‘‘Official Methods of Anal- (5) Preservatives identified in a regu- ysis of the Association of Official Analytical lation permitting that use in this sub- Chemists,’’ 15th edition, 1990, is on file with chapter or in 9 CFR Chapter III, Sub- the Director, Office of the Federal Register, and may be purchased from the Association chapter E, or in 21 CFR Chapter I, Sub- of Official Analytical Chemists, Inc., 2200 chapter A or Subchapter B, within Wilson Boulevard, Suite 400, Arlington, Vir- these maximum amounts in percent by ginia 22201. weight of the finished food: Sorbic

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acid, benzoic acid and their sodium, po- bicarbonate, sodium carbonate, and so- tassium, and calcium salts, individ- dium hydroxide. ually, 0.1 percent, or in combination, (11) For the purposes of this section, 0.2 percent, expressed as the acids; cal- the term ‘‘milk’’ unqualified means cium disodium EDTA, 0.0075 percent; milk from cows. If any milk other than stearyl citrate, 0.15 percent; isopropyl cow’s milk is used in whole or in part, citrate mixture, 0.02 percent. the animal source shall be identified in (6) Antioxidants identified in a regu- conjunction with the word ‘‘milk’’ in lation permitting that use in this sub- the ingredient statement. chapter or in 9 CFR Chapter III, Sub- [48 FR 52697, Nov. 22, 1983, as amended at 50 chapter E, or in 21 CFR Chapter I, Sub- FR 3739, Jan. 28, 1985; 54 FR 40632, Oct. 3, 1989; chapter A or Subchapter B, within 59 FR 33642, June 30, 1994; 64 FR 72175, Dec. these maximum amounts in percent by 23, 1999] weight of the finished food: propyl, octyl and dodecyl gallates, BHT § 319.701 Mixed fat shortening. (butylated hydroxytoluene), BHA Shortening prepared with a mixture (butylated hydroxyanisole), ascorbyl of meat fats and vegetable oils may be palmitate, ascorbyl stearate, all indi- identified either as ‘‘Shortening Pre- vidually or in combination, 0.02 per- pared with Meat Fats and Vegetable cent. Instead of these antioxidants, Oils’’ or ‘‘Shortening Prepared with TBHQ (tertiary butylhydroquinone), Vegetable Oils and Meat Fats’’ depend- alone or in combination only with BHT ing on the predominance of the fat and and/or BHA, with a maximum 0.02 per- oils used, or the product may be la- cent by weight of the fat and oil con- beled ‘‘Shortening’’ when accompanied tent. by an ingredient statement with ingre- (7) Coloring agents identified in a dients listed in descending order of pre- regulation permitting that use in this dominance. subchapter or in 9 CFR Chapter III, Subchapter E, or in 21 CFR Parts 73, 74, § 319.702 Lard, leaf lard. 81, or 82, in amounts sufficient for pur- (a) Lard is the fat rendered from 3 pose. For the purpose of this subpara- clean and sound edible tissues from graph, provitamine A (beta-carotene) swine. The tissues may be fresh, frozen, shall also be deemed to be a coloring cooked, or prepared by other processes agent. approved by the Administrator in spe- (8) Flavoring substances in amounts cific cases, upon his determination sufficient for purpose. that the use of such processes will not (9) Acidulants identified in a regula- result in the adulteration or mis- tion permitting that use in this sub- branding of the lard. The tissues shall chapter or in 9 CFR Chapter III, Sub- be reasonably free from blood, and chapter E, or in 21 CFR Chapter I, Sub- shall not include stomachs, livers, chapter A or Subchapter B, in amounts spleens, kidneys, and brains, or sufficient for purpose: adipic acid; cit- settlings and skimmings. ‘‘Leaf Lard’’ ric and lactic acids and their potassium is lard prepared from fresh leaf (abdom- and sodium salts; phosphoric acid; L- inal) fat. tartaric acid and its sodium and so- (b) Lard (when properly labeled) may dium-potassium salts; and hydrochloric be hardened by the use of lard stearin acid. (10) Alkalizers identified in a regula- or hydrogenated lard or both and may tion permitting that use in this sub- contain refined lard and deodorized chapter or in 9 CFR Chapter III, Sub- lard, but the labels of such lard shall chapter E, or in 21 CFR Chapter I, Sub- state such facts, as applicable. chapter A or Subchapter B, in amounts (c) Products labeled ‘‘Lard’’ or ‘‘Leaf sufficient for purpose: potassium bicar- Lard’’ must have the following identity bonate, potassium carbonate, sodium and quality characteristics to insure good color, odor, and taste of finished product: 3 Colored margarine or oleomargarine is also subject to the provisions of section 407 (1) Color ...... White when solid, Maximum 3.0 red units in a 51⁄4 inch cell on of the Federal Food, Drug, and Cosmetic Act, the Lovibond scale. as amended (21 U.S.C. 347), as reflected in (2) Odor and taste ...... Characteristic and free from for- § 317.8(h)(24) of this subchapter. eign odors and flavors.

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(3) Free fatty acid ...... Maximum 0.5 percent (as oleic) (b) The moisture content of ‘‘Deviled or 1.0 acid value, as milligrams Tongue’’ and similar products shall not KOH per gram of sample. (4) Peroxide value ...... Maximum 5.0 (as milliequivalents exceed that of the fresh, unprocessed of peroxide per kilogram fat). meat. (5) Moisture and volatile Maximum 0.2 percent. matter. [35 FR 15597, Oct. 3, 1970, as amended at 43 FR (6) Insoluble impurities.... By appearance of liquid, fat or 26425, June 20, 1978; 47 FR 28257, June 29, 1982] maximum 0.05 percent. (d) Product found upon inspection § 319.761 Potted meat food product not to have the characteristics speci- and deviled meat food product. fied in paragraph (c) of this section but ‘‘Potted Meat Food Product’’ and found to be otherwise sound and in ‘‘Deviled Meat Food Product’’ shall not compliance with paragraph (a) of this contain cereal, vegetable flour, nonfat section may be further processed for dry milk, or similar substances. The the purpose of achieving such charac- amount of water added to potted meat teristics. food product and deviled meat food [43 FR 25420, June 13, 1978] product shall be limited to that necessary to replace moisture lost during § 319.703 Rendered animal fat or mix- processing. ture thereof. ‘‘Rendered Animal Fat,’’ or any mix- § 319.762 Ham spread, tongue spread, ture of fats containing edible rendered and similar products. animal fat, shall contain no added ‘‘Ham Spread,’’ ‘‘Tongue Spread,’’ water, except that ‘‘Puff Pastry Short- and similar products shall contain not ening’’ may contain not more than 10 less than 50 percent of the meat ingre- percent of water. dient named, computed on the weight [35 FR 15597, Oct. 3, 1970, as amended at 43 FR of the fresh meat. Other meat and fat 25420, June 13, 1978] may be used to give the desired spread- ing consistency provided it does not de- Subpart Q—Meat Soups, Soup tract from the character of the spreads Mixes, Broths, Stocks, Extracts named. Mechanically Separated (Spe- cies) may be used in accordance with § 319.720 Meat extract. § 319.6. Meat extract (e.g., ‘‘Beef Extract’’) [35 FR 15597, Oct. 3, 1970, as amended at 43 FR shall contain not more than 25 percent 26425, June 20, 1978; 47 FR 28257, June 29, 1982] of moisture.

§ 319.721 Fluid extract of meat. Subpart S—Meat Baby Foods Fluid extract of meat (e.g., ‘‘Fluid [Reserved] Extract of Beef’’) shall contain not more than 50 percent of moisture. Subpart T—Dietetic Meat Foods [Reserved] Subpart R—Meat Salads and Meat Spreads Subpart U—Miscellaneous

§ 319.760 Deviled ham, deviled tongue, § 319.880 Breaded products. and similar products. The amount of batter and breading (a) ‘‘Deviled Ham’’ is a semiplastic used as a coating for breaded product cured meat food product made from shall not exceed 30 percent of the finely comminuted ham and containing weight of the finished breaded product. condiments. Mechanically Separated (Species) may be used in accordance § 319.881 Liver meat food products. with § 319.6. Deviled ham may contain added ham fat: Provided, That the total Meat food products characterized and fat content shall not exceed 35 percent labeled as liver products such as liver of the finished product. The moisture loaf, liver cheese, liver spread, liver content of deviled ham shall not exceed mush, liver paste, and liver pudding that of the fresh unprocessed meat. shall contain not less than 30 percent 314

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of pork, beef, sheep, or goat livers com- (b) The required records are: puted on the fresh weight of the livers. (1) Records, such as bills of sale, invoices, bills of lading, and receiving [36 FR 12004, June 24, 1971] and shipping papers, giving the following information with respect to PART 320—RECORDS, each transaction in which any live- REGISTRATION, AND REPORTS stock or carcass, part thereof, meat or meat food product is purchased, sold, Sec. shipped, received, transported, or oth- 320.1 Records required to be kept. erwise handled by said person in con- 320.2 Place of maintenance of records. nection with any business subject to 320.3 Record retention period. 320.4 Access to and inspection of records, fa- the Act: cilities and inventory; copying and sam- (i) The name or description of the pling. livestock or article; 320.5 Registration. (ii) The net weight of the livestock or 320.6 Information and reports required from article; official establishment operators. (iii) The number of outside con- 320.7 Reports by consignees of allegedly tainers (if any); adulterated or misbranded products; sale (iv) The name and address of the or transportation as violations. buyer of livestock or article sold by AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.7, such person, and the name and address 2.18, 2.53. of the seller of livestock or articles SOURCE: 35 FR 15603, Oct. 3, 1970, unless purchased by such person; otherwise noted. (v) The name and address of the consignee or receiver (if other than the § 320.1 Records required to be kept. buyer); (a) Every person (including every (vi) The method of shipment; firm or corporation) within any of the (vii) The date of shipment; and classes specified in paragraph (a) (1), (viii) The name and address of the (2), or (3) of this section is required by carrier. the Act to keep records which will (ix) In the case of a person belonging fully and correctly disclose all trans- to the class specified in paragraph actions involved in his or its business (a)(1), and engaged, for commerce, in subject to the Act: the business of slaughtering any swine (1) Any person that engages, for com- for use as human or animal food, the merce, in the business of slaughtering name and address (including the city any cattle, sheep, swine, goats, horses, and state, or the township, county, and mules, or other equines, or preparing, state) of each person from whom the freezing, packaging, or labeling any person belonging to the class so speci- carcasses, or parts or products of car- fied purchased or otherwise obtained casses, of any such animals, for use as each swine, and the telephone number, human food or animal food; if available, of the person from whom (2) Any person that engages in the the swine were purchased or otherwise business of buying or selling (as a meat obtained, and all serial numbers and broker, wholesaler, or otherwise), or other approved means of identification transporting in commerce, or storing appearing on all test swine selected at in or for commerce, or importing, any antemortem inspection by FSIS rep- carcasses, or parts or products of car- resentatives for residue testing. casses, of any such animals; (2) Shipper’s certificates and permits (3) Any person that engages in busi- required to be kept by shippers and ness, in or for commerce, as a renderer, carriers of articles under part 325 of or engages in the business of buying, this subchapter. selling, or transporting in commerce, (3) A record of seal numbers required or importing, any dead, dying, dis- to be kept by consignees of inedible abled, or diseased cattle, sheep, swine, products shipped under unofficial seals goats, horses, mules, or other equines, under § 325.11(b) or (e) of this sub- or parts of the carcasses of any such chapter, and a record of new consignees animals that died otherwise than by of inedible products diverted under slaughter. § 325.11(e) of this subchapter.

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(4) [Reserved] under the Act, by written notice to the (5) Guaranties provided by suppliers person required to keep such records of packaging materials under § 317.24. under this part. (6) Records of canning as required by (b) Records of canning as required in subpart G of this subchapter A, 9 CFR subpart G of this subchapter A, 9 CFR chapter III. chapter III, shall be retained as re- (7) Sample results and calculation required in § 318.307(e); except that sults as required by processing proce- records required by § 318.302 (b) and (c) dures to destroy trichinae in shall be retained as required by those § 318.10(c)(3)(iv) (Methods 5 and 6). sections. (8) Records of nutrition labeling as required by subpart B, part 317, of this [35 FR 15603, Oct. 3, 1970, as amended at 51 FR subchapter. 45633, Dec. 19, 1986] (9) Records as required in § 318.23(b) and (c). § 320.4 Access to and inspection of (10) Records documenting the devel- records, facilities and inventory; opment, implementation, and mainte- copying and sampling. nance of procedures for the control of Representatives of the Secretary af- the production process using advanced forded access to a business specified in meat/bone separation machinery and § 320.1 of this part (see § 300.6(b)(2) of meat recovery systems as required by this chapter) also must be afforded any § 318.24 of this subchapter. necessary facilities (other than repro- (11) Records of all labeling, along duction equipment) for the examina- with the product formulation and proc- tion and copying of records and for the essing procedures, as prescribed in examination and sampling of inven- § 317.4 and § 317.5. tory. (Approved by the Office of Management and [69 FR 254, Jan. 5, 2004] Budget under control number 0583–0015) [35 FR 15603, Oct. 3, 1970] § 320.5 Registration. EDITORIAL NOTE: For FEDERAL REGISTER ci- (a) Except as provided in paragraph tations affecting § 320.1, see the List of CFR (c) of this section, every person that Sections Affected, which appears in the engages in business in or for commerce, Finding Aids section of the printed volume and at www.fdsys.gov. as a meat broker, renderer, or animal food manufacturer, or engages in busi- § 320.2 Place of maintenance of ness in commerce as a wholesaler of records. any carcasses, or parts or products of Every person engaged in any business the carcasses, or any livestock, wheth- described in § 320.1 and required by this er intended for human food or other part to keep records shall maintain purposes, or engages in business as a such records at the place where such public warehouseman storing any such business is conducted except that if articles in or for commerce, or engages such person conducts such business at in the business of buying, selling, or multiple locations, he may maintain transporting in commerce, or import- such records at his headquarters’ of- ing, any dead, dying, disabled, or dis- fice. When not in actual use, all such eased livestock, or parts of the car- records shall be kept in a safe place at casses of any such livestock that died the prescribed location in accordance otherwise than by slaughter, shall reg- with good commercial practices. ister with the Administrator, giving such information as is required, includ- § 320.3 Record retention period. ing his name, and the address of each (a) Every record required to be main- place of business at which, and all tained under this part shall be retained trade names under which he conducts for a period of 2 years after December such business, by filing with the Ad- 31 of the year in which the transaction ministrator, Food Safety and Inspec- to which the record relates has oc- tion Service, U.S. Department of Agri- curred and for such further period as culture, Washington, DC 20250, a form the Administrator may require for pur- containing such information within 90 poses of any investigation or litigation days after the effective date hereof or

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after such later date as he begins to en- reports as the Administrator may from gage in such business if not engaged time to time require under the Act. therein upon said effective date. All in- [35 FR 15603, Oct. 3, 1970, as amended at 45 FR formation submitted shall be current 76968, Nov. 21, 1980; 61 FR 38866, July 25, 1996] and correct. The registration form shall be obtained from Evaluation and § 320.7 Reports by consignees of alleg- Enforcement Division, Office of Pro- edly adulterated or misbranded gram Evaluation, Enforcement, and products; sale or transportation as Review, Food Safety and Inspection violations. Service, U.S. Department of Agri- Whenever the consignee of any prod- culture, Washington, DC 20250, or by uct which bears an official inspection calling the District Office. legend refuses to accept delivery of (b) Whenever any change is made in such product on the grounds that it is the name of, or address of any place of adulterated or misbranded, the con- business at which, or any trade name signee shall notify the Inspector in under which a registrant conducts his Charge, Meat and Poultry Inspection business, he shall report such change in Program, Food Safety and Inspection writing to the Administrator within 15 Service, U.S. Department of Agri- days after making the change. culture, of the kind, quantity, source, and present location of the product and (c) The registration requirements the respects in which it is alleged to be prescribed in this section shall not adulterated or misbranded, and it will apply to persons conducting any of the be a violation of the Act for any person businesses specified in this section only to sell or transport, or offer for sale or at an official establishment. transportation, or receive for transpor- [35 FR 15603, Oct. 3, 1970, as amended at 57 FR tation, in commerce, any such product 53982, Nov. 16, 1992; 69 FR 254, Jan. 5, 2004] which is capable of use as human food and is adulterated or misbranded at the § 320.6 Information and reports re- time of such sale, transportation, offer, quired from official establishment or receipt: Provided, however, That any operators. such allegedly adulterated or mis- (a) The operator of each official es- branded product may be transported to tablishment shall furnish to Program the official establishment from which employees accurate information as to it had been transported, in accordance all matters needed by them for making with § 325.10 of this subchapter. their daily reports of the amount of products prepared or handled in the de- PART 321—COOPERATION WITH partments of the establishment to STATES AND TERRITORIES which they are assigned and such reports concerning sanitation, manda- Sec. tory microbiological testing, and other 321.1 Assistance to State and Territorial aspects of the operations of the estab- programs. lishment and the conduct of inspection, 321.2 Cooperation of States in Federal pro- as may be required by the Adminis- grams. 321.3 Cooperation of States for the inter- trator in special cases. state shipment of carcasses, parts of car- (b) The operator of each official es- casses, meat, and meat food products. tablishment shall report quarterly the AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.18, number of pounds of meat and meat 2.53. food product produced at that establishment. The report shall be made on § 321.1 Assistance to State and Terri- a form furnished by the Administrator torial programs. and shall be submitted to an inspector (a) The Administrator is authorized at the establishment. Each report shall under paragraph (a) of section 301 of cover a calendar quarter and shall be the Act, when he determines it would filed within 15 days after the end of effectuate the purposes of the Act, to each quarter. cooperate with any State (including (c) The operator of each official es- Puerto Rico) or any organized Terri- tablishment shall also make such other tory in developing and administering

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the meat inspection program of such § 321.3 Cooperation of States for the jurisdiction with a view to assuring interstate shipment of carcasses, that it imposes and enforces require- parts of carcasses, meat, and meat ments at least equal to those under Ti- food products. tles I and IV of the Act, with respect to (a) The Administrator is authorized establishments at which products are under 21 U.S.C. 683(b) to coordinate prepared for use as human food solely with States that have meat inspection for distribution within such jurisdic- programs as provided in § 321.1 of this tion, and with respect to the products part to select certain establishments of such establishments. Such coopera- operating under these programs to par- tion is authorized if the jurisdiction ticipate in a cooperative program to has enacted a law imposing mandatory ship carcasses, parts of carcasses, ante-mortem and post-mortem inspec- meat, and meat food products in inter- tion, reinspection, and sanitation re- state commerce. A cooperative pro- quirements at least equal to the Fed- gram for this purpose is called a ‘‘co- eral requirements with respect to all or operative interstate shipment pro- certain classes of persons engaged in gram.’’ slaughtering livestock or otherwise (b) Establishments selected to par- preparing products solely for distribu- ticipate in a cooperative interstate tion within such jurisdiction. shipment program described in this (b) The Administrator is also author- section must receive inspection serv- ized under paragraph (a) of section 301 ices from designated State personnel of the Act to cooperate with any State that have been trained in the enforce- (including Puerto Rico) or any orga- ment of the Act. If the designated per- nized Territory in developing and ad- sonnel determine that the carcasses, ministering programs under the laws of parts of carcasses, meat, and meat food such jurisdiction containing authori- products prepared in establishments se- ties at least equal to those in Title II lected to participate in the cooperative of the Act (relating to records; registration of specified classes of opera- interstate shipment program comply tors; dead, dying, disabled, or diseased with all requirements under the Act, livestock; and products not intended these items will bear an official Fed- for human food), when he determines eral mark of inspection and may be that such cooperation would effectuate shipped in interstate commerce. The the purposes of the Act. Administrator will assign an FSIS (c) Such cooperation may include ad- ‘‘selected establishment coordinator,’’ visory assistance, technical and labora- who will be an FSIS employee, to each tory assistance and training, and finan- State that participates in a coopera- cial aid. The Federal contribution to tive interstate shipment program to any State (or Territory) may not ex- provide Federal oversight of the proceed 50 percent of the estimated total gram and enforcement of the program’s cost of the cooperative State (or Terri- requirements. The Federal contribu- torial) program. A cooperative pro- tion for inspection services provided by gram under this section is called a States that enter into a cooperative State-Federal program. interstate shipment program under this section will be at least 60 percent [35 FR 15604, Oct. 3, 1970] of eligible State costs. Eligible State costs are those costs that a State has § 321.2 Cooperation of States in Fed- justified and FSIS has approved as nec- eral programs. essary for the State to provide inspec- Under the ‘‘Talmadge-Aiken Act’’ of tion services to selected establish- September 28, 1962 (7 U.S.C. 450), the ments in the State. Administrator is authorized to utilize (c) Part 332 of this subchapter pre- employees and facilities of any State scribes conditions under which States in carrying out Federal functions and establishments may participate in under the Federal Meat Inspection Act. the cooperative interstate shipment A cooperative program for this purpose program. is called a Federal-State program. (d) The Administrator will terminate [35 FR 15604, Oct. 3, 1970] a cooperative interstate shipment

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agreement with a State if the Adminis- § 322.2 Export certificates; instructions trator determines that the State is not concerning issuance. conducting inspection at selected es- (a) Upon application of the exporter, tablishments in a manner that com- the inspector in charge is authorized to plies with the Act and the imple- issue official export certificates for menting regulations in this chapter. shipments of inspected and passed [76 FR 24752, May 2, 2011] product to any foreign country. Certifi- cates should be issued at the time the PART 322—EXPORTS 1 products leave the official establishment; if not issued at that time they Sec. may be issued later only after identi- 322.1 Manner of affixing stamps and mark- fication and reinspection of the prod- ing products for export. 322.2 Export certificates; instructions con- ucts. cerning issuance. (b) Official export certificates shall 322.3 Transferring products for export. be issued with serial numbers and in 322.4 Clearance of vessels and transpor- triplicate form. Quadruplicate certifi- tation without certificate prohibited; ex- cates may be issued for any expor- ceptions. tation on request of the exporter. Each 322.5 Uninspected tallow, stearin, oleo oil, etc., not to be exported unless certified certificate shall show the names of the as prescribed. exporter and the consignee, the destination, the number and types of AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, 2.55. packages, the shipping marks, the kinds of products, and the weight of SOURCE: 35 FR 15604, Oct. 3, 1970, unless the products in accordance with § 317.2 otherwise noted. of this subchapter. § 322.1 Manner of affixing stamps and (c) Only one certificate shall be marking products for export. issued for each consignment, except (a) The outside container (including that for sufficient reasons new certifi- cloth wrappings) of any inspected and cates in lieu of the original certificates passed product for export, except ship may be issued. A certificate issued in stores, small quantities exclusively for lieu of another shall show in the left the personal use of the consignee and hand margin the notation ‘‘Issued in not for sale or distribution, and ship- lieu of * * *’’, and the number of the ments by and for the U.S. Armed certificate which is superseded. The Forces, shall be marked with an offi- certificate that is superseded when an- cial export stamp, as shown in § 312.8 of other is issued in lieu thereof, shall if this subchapter, bearing the number of available, be surrendered to the inspec- the export certificate. tor in charge and marked by him to (b) Each tank car of inspected and show in the left hand margin the num- passed lard or similar edible product, ber of the certificate which supersedes and each door of each railroad car or it, as follows: ‘‘Superseded by No. other closed means of conveyance, con- ll’’. taining inspected and passed loose (d) The original of the certificate product shipped directly to a foreign shall be delivered to the shipper and country, shall be marked with an offi- may be furnished by him to the con- cial export stamp, as shown in § 312.8 of signee for purposes of effecting the this subchapter, bearing the number of entry of product into the foreign coun- the export certificate. try of destination. (e) The duplicate of the certificate [42 FR 11825, Mar. 1, 1977, as amended at 50 shall be delivered to the shipper and FR 25204, June 18, 1985] shall be delivered by the shipper to the agent of the railroad or other carrier 1 Attention is directed to the requirements which transports the consignment from of part 325 of this subchapter, governing the United States otherwise than by transportation, and to the requirements of § 318.8 of this subchapter that products pre- water, or to the chief officer of the ves- pared under that section for export be de- sel on which the export shipment is stroyed for food purposes before being sold or made, or to the vessel’s agent and shall offered for sale for domestic use. be used only by such carrier and only

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for the purpose of effecting the trans- the United States to any foreign coun- portation of the consignment certified. try, any products, unless and until an The chief officer of the vessel or the official export certificate covering the vessel’s agent, shipper or shipper’s same has been issued and delivered as agent shall file such duplicate with the provided in this part; except in the case Customs officer within four (4) business of inspected and passed ship stores and days of the clearance of the vessel at not more than 50 pounds of inspected the time of filing the complete mani- and passed product for the exclusive fest. In the interim period, the vessel personal use of the consignee and not will be cleared by Customs on the basis for sale or distribution, and except for of a statement, under the shipper’s or exempted product eligible for expor- agent’s letterhead, containing the tation under the provisions of the Act number of boxes, the number of and the regulations in this subchapter pounds, the product name and the and inedible product that is not capa- USDA export certificate number that ble of use as human food and is eligible covers the shipment of the product. No for exportation under other provisions clearance shall be given to a vessel car- of said regulations. rying meat products unless either the [38 FR 18868, July 16, 1973] duplicate of the certificate or the prescribed statement referencing the cer- § 322.5 Uninspected tallow, stearin, tificate has been presented to Customs. oleo oil, etc., not to be exported un- (f) The triplicate of the certificate less certified as prescribed. shall be retained in the circuit file. No tallow, stearin, oleo oil, or the (g) Under no circumstances shall the rendered fat derived from the carcasses original or the triplicate of such cer- of livestock, that has not been in- tificate be used for the purpose pre- spected and passed, and so marked in scribed by paragraph (e) of this section compliance with the regulations in this for the duplicate. subchapter shall be exported, unless (h) Upon request, official export cer- the product has been denatured as re- tificates may be issued by inspectors quired by § 314.5 or § 325.13 of this sub- for export consignments of product of chapter or identified and marked as official establishments not under their prescribed by § 325.11 of this sub- supervision, provided the consignments chapter. are first identified as having been ‘‘U.S. inspected and passed’’ and are [35 FR 15604, Oct. 3, 1970, as amended at 47 FR found to be neither adulterated nor 17274, Apr. 22, 1982] misbranded, and marked as required by § 322.1. PART 325—TRANSPORTATION

[35 FR 15604, Oct. 3, 1970, as amended at 42 FR Sec. 11826, Mar. 1, 1977; 51 FR 31938, Sept. 8, 1986] 325.1 Transactions in commerce prohibited without official inspection legend or cer- § 322.3 Transferring products for ex- tificate when required; exceptions; and port. vehicle sanitation requirements. When inspected and passed products 325.2 Parcel post and ferries deemed car- for export are transferred from tank riers. cars to other containers on vessels, 325.3 Product transported within the United States as part of export movement. such transfer shall be done in accord- 325.4 [Reserved] ance with the provisions of part 350 of 325.5 Unmarked inspected product trans- subchapter B of this chapter. ported under official seal between official establishments for further processing; § 322.4 Clearance of vessels and trans- certificate. portation without certificate pro- 325.6 Shipment of paunches between official hibited; exceptions. establishments under official seal; cer- No clearance shall be given to any tificate. vessel having on board any product 325.7 Shipment of products requiring special supervision between official establish- destined to any foreign country, and no ments under official seal; certificate. person operating any vessel, and no 325.8 Transportation and other transactions railroad or other carrier, shall receive concerning certain undenatured lungs or for transportation or transport from lung lobes from official establishments

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or in commerce; provisions and restric- uct until a certificate, if required for tions. such transportation by this part, is 325.9 [Reserved] made and furnished to the carrier in 325.10 Handling of products which may have one of the forms prescribed in this become adulterated or misbranded; authorization and other requirements. part. 325.11 Inedible articles: denaturing and (2) Product imported into the United other means of identification; excep- States may be transported and offerred tions. or received for transportation if such 325.12 [Reserved] product is conveyed in railroad cars, 325.13 Denaturing procedures. trucks or other means of conveyance, 325.14 Certificates, retention by carrier. prior to inspection, to an authorized 325.15 Evidence of proper certification required on waybills; transfer bills, etc., place of inspection, as provided in for shipment by connecting carrier; § 327.6 of this part. forms of statement. (c) No person, engaged in the busi- 325.16 Official seals; forms, use, and break- ness of buying, selling, freezing, storing. ing, or transporting, in or for com- 325.17 Loading or unloading products in merce, meat or meat food products ca- sealed railroad cars, trucks, etc., en pable of use as human food, or import- route prohibited; exception. ing such articles, shall transport, offer 325.18 Diverting of shipments, breaking of seals, and reloading by carrier in emer- for transportation, or receive for trans- gency; reporting to Regional Director. portation in commerce or in any State 325.19 Provisions inapplicable to specimens designated under § 331.2 of this sub- for laboratory examination, etc., or to chapter, any such meat or meat food naturally inedible articles. product which is capable of use as 325.20 Transportation and other trans- human food and is not wrapped, pack- actions concerning dead, dying, disabled, aged, or otherwise enclosed to prevent or diseased livestock, and parts of car- adulteration by airborne contami- casses of livestock that died otherwise than by slaughter. nants, unless the railroad car, truck, or 325.21 Means of conveyance in which dead, other means of conveyance in which dying, disabled, or diseased livestock and the product is contained or transported parts of carcasses thereof shall be trans- is completely enclosed with tight fit- ported. ting doors or other covers for all open- AUTHORITY: 7 U.S.C. 450, 1901–1906; 21 U.S.C. ings. In all cases, the means of convey- 601–695; 7 CFR 2.17, 2.55. ance shall be reasonably free of foreign matter (such as dust, dirt, rust, or SOURCE: 35 FR 15605, Oct. 3, 1970, unless otherwise noted. other articles or residues), and free of chemical residues, so that product § 325.1 Transactions in commerce pro- placed therein will not become adulter- hibited without official inspection ated. Any cleaning compound, lye, soda legend or certificate when required; solution, or other chemical used in exceptions; and vehicle sanitation cleaning the means of conveyance must requirements. be thoroughly removed from the means (a) No person shall sell, transport, of conveyance prior to its use. Such offer for sale or transportation, or re- means of conveyance onto which prod- ceive for transportation, in commerce, uct is loaded, being loaded, or intended any product which is capable of use as to be loaded, shall be subject to inspec- human food unless the product and its tion by an inspector at any official es- container, if any, bear the official in- tablishment. The decision whether or spection legend as required under parts not to inspect a means of conveyance 316 and 317 of this subchapter or such in a specific case, and the type and ex- product is exempted from the require- tent of such inspection shall be at the ment of inspection under part 303 of Program’s discretion and shall be ade- this subchapter. quate to determine if product in such (b)(1) No carrier shall transport or re- conveyance is, or when moved could be- ceive for transportation in commerce come, adulterated. Circumstances of (including transportation in the course transport that can be reasonably an- of importation) and no person shall ticipated shall be considered in making offer for transportation any carcass, said determination. These include, but part thereof, meat or meat food prod- are not limited to, weather conditions,

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duration and distance of trip, nature of transported in a railroad car, product covering, and effect of restow- motortruck, or other means of convey- age at stops en route. Any means of ance which is sealed by a Program em- conveyance found upon such inspection ployee with an official seal of the De- to be in such condition that product partment prescribed in § 312.5(a) of this placed therein could become adulter- subchapter. Unless 25 percent or more ated shall not be used until such condi- of the contents of each car or other tion which could cause adulteration is means of conveyance consists of prod- corrected. Product placed in any means uct not marked with the inspection of conveyance that is found by the in- legend, transportation will not be per- spector to be in such condition that the mitted under this paragraph. product may have become adulterated (b) When articles are offered for shall be removed from the means of transportation under paragraph (a) of conveyance and handled in accordance this section, the initial carrier shall re- with § 318.2(d) of this subchapter. quire, and the shipper shall make in duplicate and deliver to the carrier, [35 FR 15605, Oct. 3, 1970, as amended at 41 FR 23700, June 11, 1976; 47 FR 17274, Apr. 22, 1982; one copy of a certificate in the fol- 56 FR 65180, Dec. 16, 1991] lowing form: 1 Date llllllllllll, 19ll § 325.2 Parcel post and ferries deemed Name of carrier lllllllllllllll carriers. Establishment number of consignor llll (a) For the purposes of this sub- Point of shipment llllllllllllll chapter, the United States parcel post Establishment number of consignee llll shall be deemed a carrier, and the pro- Destination lllllllllllllllll Car number and initials lllllllllll visions of this subchapter relating to License number of other means of convey- transportation by carrier shall apply, ance llllllllllllllllllll so far as they may be applicable, to transportation by parcel post. I hereby certify that the following described product has been U.S. inspected and (b) For the purposes of this sub- passed by the U.S. Department of Agri- chapter, the operator of every ferry culture; and that it is not marked ‘‘U.S. in- shall be deemed a carrier, and the pro- spected and passed,’’ but has been placed in visions of this subchapter relating to the means of conveyance specified above transportation by carrier shall apply to under the supervision of an employee of the transportation by ferry of any products Meat and Poultry Inspection Programs of loaded on a truck or other vehicle, or said Department, and the means of convey- otherwise moved by such ferry. ance has been sealed by him with official U.S. Government seals Nos. ll and ll. § 325.3 Product transported within the Kind of product Amount and weight United States as part of export movement. llllllllllllllllllllllll llllllllllllllllllllllll When any shipment of any product is llllllllllllllllllllllll offered to any carrier for transportation within the United States as a (Signature of shipper) part of an export movement, the same (Address of shipper) certificate shall be required as if the When paunches are offered for trans- shipment were destined to a point portation under this paragraph, the within the United States. initial carrier shall require, and the § 325.4 [Reserved] shipper shall make in duplicate and deliver to the carrier, one copy of a cer- § 325.5 Unmarked inspected product tificate in duplicate in the form set out transported under official seal be- in § 325.5(b), appropriately modified. tween official establishments for Certificates in this form or copies further processing; certificate. thereof need not be forwarded to any (a) Any product which has been in- official or office of the Department, spected and passed may be transported but the original of the certificate shall from one official establishment to another for further processing without 1 For convenience in filing, it is requested each article being marked with the of- that these certificates be made on paper ficial inspection legend, if it is so 51⁄2×8 inches in size.

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be retained by the carrier and a copy to another official establishment in the shall be retained by the shipper in ac- same railroad car or other means of cordance with part 320 of this sub- conveyance with other product, such chapter. If the shipper is also the car- restricted product shall be packed in rier, he shall nevertheless execute and individual closed containers as herein- retain the certificate in accordance after provided. Containers shall be with part 320 of this subchapter. sealed by firmly applying a pressure (c) The signature of the shipper or his sensitive tape around each container in agent shall be written in full. This cer- two directions and stamping the inter- tificate may be stamped upon or incor- section of the tape with the marking porated in any form ordinarily used in device described in § 312.2(a) of this sub- the transportation of product. Certifi- chapter for use on burlap, muslin, etc. cates in this form or copies thereof (21⁄2-inch rubber brand). Such tape must need not be forwarded to any official or possess the adhesive property to actu- office of the Department. The original ally remove a portion of the container of the certificate required by this sec- surface when the tape is removed. Al- tion shall be retained by the carrier ternatively, an inelastic, nonmetallic and a copy shall be retained by the strap which will retain a legible im- shipper in accordance with part 320 of print of the marking device (21⁄2-inch this subchapter. If the shipper is also rubber brand) may be used. The im- the carrier, he shall nevertheless exe- print of the marking device shall be cute and retain the certificate in ac- placed partially on the strap and par- cordance with part 320 of this sub- tially on the container. Such restricted chapter. product shall be marked ‘‘U.S. passed for cooking’’ or ‘‘pork product ll °F. § 325.6 Shipment of paunches between official establishments under offi- lldays refrigeration’’ or ‘‘beef passed cial seal; certificate. for refrigeration,’’ as the case may be. In addition, a ‘‘U.S. retained’’ tag shall Cattle and sheep paunches which be securely affixed to each container of have been made clean and from which product passed for cooking and of beef the mucous membrane has not been re- passed for refrigeration. The means of moved may be transported from one of- conveyance shall not be sealed unless ficial establishment to another official at least 25 percent of the other product establishment for further processing, in the vehicle is unmarked. For each only under an official seal of the De- consignment there shall be promptly partment as prescribed in § 312.5(a) of issued and forwarded by the inspector this subchapter. to the inspector in charge at destina- § 325.7 Shipment of products requiring tion, a report on the form entitled special supervision between official ‘‘Notice of Unmarked Meats Shipped in establishments under official seal; Sealed Cars,’’ appropriately modified certificate. to show the character of the con- (a) Products passed for cooking, pork tainers, and that the contents are re- that has been refrigerated to destroy stricted. A duplicate copy shall be re- trichinae, and beef that is to be refrig- tained in the program files. erated to destroy cysticerci, may be (c) When products are offered for shipped loose from one official estab- transportation under this section, the lishment to any other official estab- initial carrier shall require and the lishment, for further handling in ac- shipper shall make in duplicate and de- cordance with part 318 of this sub- liver to the carrier one copy of a cer- chapter, in railroad cars, trucks, or tificate in the form set out in § 325.5(b). other means of conveyance sealed with Certificates in this form or copies the official seal of the Department as thereof need not be forwarded to any prescribed in § 325.16: Provided, That in official or office of the Department, the case of railroad cars, the receiving but the original of the certificate shall establishment has railroad facilities be retained by the carrier and a copy for unloading the products directly shall be retained by the shipper in ac- into the establishment. cordance with part 320 of this sub- (b) When such restricted product is chapter. If the shipper is also the car- shipped from one official establishment rier, he shall nevertheless execute and

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retain the certificate in accordance container of imported lungs or lung with part 320 of this subchapter. lobes. (b) Lungs or lung lobes, other than [35 FR 15605, Oct. 3, 1970, as amended at 39 FR those condemned under a State law or 20187, June 7, 1974] regulation at least equal to § 310.16(b) § 325.8 Transportation and other of this subchapter, that are prepared at transactions concerning certain any State inspected establishment may undenatured lungs or lung lobes be sold, transported, offered for sale, or from official establishments or in transportation or received for trans- commerce; provisions and restric- portation from that establishment, in tions. commerce, without denaturing as pre- (a) Lungs or lung lobes, other than scribed under section 201 of the Act, those condemned under § 310.16(b) of provided the State law or regulations this subchapter, that are prepared at permit such disposition and provided any official establishment, may be there is compliance with the provisions sold, transported, offered for sale or of paragraph (a) of this section. transportation, or received for trans- (c) Foreign establishments shall be portation from the establishment, in eligible to export lungs or lung lobes, commerce or otherwise, without dena- other than those condemned for rea- turing as prescribed in § 314.1 or § 314.3 sons set forth in § 310.16(b) of this sub- of this subchapter: Provided: chapter, to the United States from (1) The lungs or lung lobes are sold, such foreign country under this section, only if such establishments are transported, or offered for sale or certified and approved for export of transportation to, or received for products to the United States under transportation by: An animal food part 327 of this subchapter, and such manufacturer for use in manufacturing product complies with the applicable animal food; a zoo, mink farm, or other regulations for preventing the intro- establishment for use as animal food duction into the United States of dis- without further processing; a ware- eases (9 CFR 94), in addition to the re- house in the United States for storage quirements of paragraph (a) of this sec- and subsequent movement to such a tion. manufacturer or establishment in the (d) All such lungs or lung lobes, if in- United States, or from one warehouse tended for animal food, are subject to to another for the account of and sub- the Federal Food, Drug, and Cosmetic sequent movement to such a manufac- Act. turer or establishment, or for export, for nonhuman food purposes. [43 FR 43445, Sept. 26, 1978] (2) The boxes or other containers used for shipping the undenatured § 325.9 [Reserved] lungs or lung lobes are closed with § 325.10 Handling of products which nylon filament tape, metallic on non- may have become adulterated or metallic straps, round wire, or other misbranded; authorization and similar materials that securely effect other requirements. closure of such containers, and the con- (a) When it is claimed that any in- tainers are permanently identified in spected and passed product, marked at least 2-inch (5 cm) high lettering with an inspection legend, has become with the statement ‘‘(Species) Lungs— adulterated or misbranded after it has Not Intended for Human Food.’’ In lieu been transported from an official es- of securely closing the immediate con- tablishment, such product may be tainer with any of the above materials, transported in commerce to an official a 1-inch (2.5 cm) wide bright orange establishment after oral permission is band, imprinted around the length and obtained from the area supervisor of width of the container may be used. the area in which that offical establish- (3) The name and place of business of ment is located. The transportation of the packer or distributor shall be the product may be to the official es- shown on the immediate container of tablishment from which it had been the product. In addition, the country of transported or to another official es- origin shall be shown on the immediate tablishment designated by the person

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desiring to handle the product. The or misbranded, shall be offered for transportation shall be authorized only transportation in commerce by any for the purpose of officially deter- person unless it is handled in accord- mining if the product has become adul- ance with paragraph (b), (c), (d), or (e) terated or misbranded and making the of this section or is denatured or other- appropriate disposition. The area su- wise identified as prescribed in § 325.13, pervisor shall make a record of the au- § 314.1, § 314.3, § 314.9, § 314.10, or § 314.11 thorization and such other information of this subchapter. which will effectively identify the ship- (b) Inedible rendered animal fats ment and shall provide a copy of the from official or other establishments in record to the inspector at the estab- the United States having the physical lishment receiving the product. The characteristics of a meat food product shipper shall be furnished a copy of the fit for human food may be transported authorization record upon request. in commerce without denaturing, if the (b) Upon the arrival of the shipment following conditions are met: at the official establishment, a careful (1) Such inedible rendered fat shall inspection shall be made of the product not be bought, sold, transported, or of- by a Program inspector, and if it is fered for sale or offered for transpor- found that the article is not adulter- tation in commerce, or imported, ex- ated, the same may be received into cept by rendering companies, dealers, the establishment; but if the article is brokers, or others who obtain a num- found to be adulterated, it shall at bered permit for such activities from once be stamped ‘‘U.S. inspected and the Regional Director. condemned’’ and disposed of in accord- (2) Such inedible rendered animal fat ance with part 314 of this subchapter, may be so distributed only if consigned and if it is found to be misbranded, it to a domestic manufacturer of tech- shall be handled in accordance with nical articles other than for human § 318.2(d) of this subchapter: Provided, food or to an export terminal for expor- That when a product is found to be af- tation or storage for exportation as an fected with one of the correctable con- inedible article, and provided, in the ditions specified in § 318.2(d) of this sub- case of such fat consigned to a domes- chapter, in respect to which rehandling tic manufacturer, the product is for use is permitted, it may be transported solely by the consignee for manufac- from the official establishment to an- turing purposes of nonhuman food arti- other official establishment for such cles and may not be further sold or rehandling as is necessary to assure shipped without first receiving ap- that the product is not adulterated or proval of the Regional Director: And misbranded when finally released. The provided further, That such fat intended transportation of such a product from for export and stored at a terminal an official establishment shall be done point prior to export will be subject to in a manner prescribed in each specific review by Program employees to assure case by the Administrator. that it is exported as inedible. [35 FR 15605, Oct. 3, 1970, as amended at 47 FR (3) When transported in commerce, or 17274, Apr. 22, 1982] imported, such inedible rendered fat shall be marked conspicuously with the § 325.11 Inedible articles: denaturing words ‘‘technical animal fat not in- and other means of identification; tended for human food’’ on the ends of exceptions. the shipping containers, in letters not (a) Except as provided in § 325.8 and less than 2 inches high; in the case of § 325.10, no carcass, part of a carcass, shipping containers such as drums, rendered grease, tallow, or other fat de- tierces, barrels, and half barrels, and rived from the carcasses of livestock, not less than 4 inches high in the case or other meat food product, that has of tank cars and trucks. All shipping not been inspected and passed at an of- containers shall have both ends painted ficial establishment under the provi- with a durable paint, if necessary, to sions of this subchapter and is not ex- provide a contrasting background for empted from such inspection, and no the required marking. carcass, part of a carcass, fat or other (4) Such inedible rendered fat shall be meat food product that is adulterated transported only in sealed shipping

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containers bearing unofficial seals ap- food packed in hermetically sealed, re- plied by the shipper, which shall in- tort processed, conventional retail-size clude the identification number as- containers, and retail-size packages of signed by said Director for the permit semi-moist animal food need not be de- holder. The number shall appear on the natured in accordance with § 325.13(a)(2) bill of lading or other transportation if the name of the article clearly con- documents for the shipment. The conveys the article’s intended use for ani- signees in the United States must re- mal food and appeared on the label in a tain the seals in their records as pre- conspicuous manner. scribed in part 320 of this subchapter. (i) Except as provided in paragraph (5) Any diversion or effort to divert (ii) of paragraph (d)(3), the name of the inedible rendered fat contrary to the article must be stated on the label as provisions of this paragraph (b) or ‘‘Animal Food,’’ ‘‘Pet Food,’’ or other violation of the provisions of this ‘‘(name of species) Food’’ (e.g., ‘‘Dog section may result in the revocation of Food’’ or ‘‘Cat Food’’). To be consid- the permit for shipment of technical ered conspicuous, the name of the arti- animal fat at the discretion of the Ad- cle, wherever it appears on the label, ministrator. must be in letters at least twice as (c) Inedible rendered animal fat de- high, wide, and thick as the letters in- rived from condemned or other inedible dicating the presence in the article of materials at official or other establish- any ingredients derived from the car- ments in the United States may be casses of livestock. transported in commerce if mixed with (ii) Notwithstanding the provisons of low grade offal or other materials paragraph (i) of this paragraph (d)(3), which render the fat readily distin- the article’s name may be stated on guishable from an article of human the label to show that it is or contains food, and if the outside container bears livestock-source material and that the the word ‘‘inedible.’’ article is for animals; e.g., ‘‘Horsemeat (d)(1) Except as provided in para- for Pets’’ or ‘‘Beef Stew for Dogs’’: Pro- graphs (d)(2), (3), and (4) of this section, vided, That the entire name of the arti- or in §§ 314.10 and 314.11 of this sub- cle is stated, wherever it appears on chapter, no animal food prepared, in the label, as an individual, contiguous whole or in part, from materials de- unit, whether stated on a single line or rived from the carcasses of livestock in more than one line, and the letters de- an official establishment or elsewhere, noting the article’s intended use for shall be bought, sold, transported, of- animal food are at least as high, wide, fered for sale or transportation, or re- and thick as the letters indicating the ceived for transportation, in com- presence of material derived from any merce, or imported, unless: livestock carcass. However, when the (i) It is properly identified as animal label bears on its principal display food; panel a vignette which pictures, in (ii) It is not represented as being a clearly recognizable form and size, one human food; and or more animals of the species for (iii) It has been denatured as pre- which the article’s name indicates the scribed in § 325.13(a)(2) so as to be read- article is intended, the letters used to ily distinguishable from an article of state the article’s intended use shall be human food. at least one-half as high, wide, and (2) Notwithstanding the provisions of thick as the letters used in the arti- paragraph (d)(1) of this section, an ani- cle’s name or other letters indicating mal food that consists of less than 5 the presence of material derived from percent of parts or products of the car- any livestock carcass, but shall not be casses of livestock and that is not rep- less than 1⁄8 inches high. The letters resented by labeling or appearance or used to state the article’s intended use otherwise as being a human food or as may be separated from the article’s a product of the meat food industry name by the vignette. need not be denatured in accordance (iii) Letters used to denote the in- with § 325.13(a)(2). tended use of the article must contrast (3) Notwithstanding the provisions of as markedly with their background as paragraph (d)(1) of this section, animal the letters indicating the presence in

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the article of livestock carcass-source be marked conspicuously with the material contrast with their back- words ‘‘Inedible—Not Intended for ground. Human Food’’ in letters not less than 2 (4) The requirements of this part do inches high, in the case of containers, not apply to livestock or poultry feeds such as cartons, drums, tierces, bar- manufactured from processed livestock rels, and half barrels, and not less than byproducts (such as meat meal tank- 4 inches high in the case of tank cars age, meat and bone meal, blood meal, and trucks used to transport such prod- and feed grade animal fat), or to proc- ucts not in other containers. essed dry animal food. (4) Such inedible products shall be (e) Except for inedible rendered ani- transported from an official establish- mal fats and lungs or lung lobes, ined- ment or in commerce under this para- ible products (including condemned graph (e) only in railroad cars, trucks, products only if condemned for causes or containers which bear unofficial specified in § 314.11 of this subchapter) seals applied by the shipper, which which were prepared at any official es- shall include the identification number tablishment, or at any State inspected assigned to the permit holder and an establishment in any State not listed individual seal serial number assigned in § 331.2 of this subchapter, and which by the shipper; and the product so have the physical characteristics of a transported shall be accompanied by an product fit for human food, may be invoice or bill of lading specifying the transported from an official establish- permit holder’s identification number. ment or in commerce, without denatur- The consignee in the United States ing as required by this subchapter, if must retain a record of the identifica- the following conditions are met: tion and serial numbers shown on the (1) The shipper must have obtained a seals in his records as prescribed in numbered permit for such activity part 320 of this subchapter. from the appropriate Regional Direc- (5) Any diversion, or effort to divert, tor, as identified in § 301.2 of this sub- undenatured, inedible product contrary chapter. Such permit may be obtained to the provisions of this paragraph (e) upon written application to the appro- or other violation of the provisions of priate Regional Director and his deter- this section may result in the revoca- mination that the proposed transpor- tion of the permit for shipment of ined- tation would be authorized under this ible products under this paragraph (e), paragraph (e). The application shall at the discretion of the Administrator. state the name and address of the ap- [47 FR 17274, Apr. 22, 1982, as amended at 49 plicant, a description of the type of his FR 47478, Dec. 5, 1984] business operations, and the purpose of making such application. § 325.12 [Reserved] (2) Such inedible products may be transported under this paragraph (e) § 325.13 Denaturing procedures. only if consigned to a manufacturer in (a) Carcasses, parts thereof, meat and the United States of articles other meat food products (other than ren- than for human food and if the product dered animal fats) that have been is for use solely by the consignee for treated in accordance with the provi- manufacturing articles not for human sions of this paragraph shall be consid- food. Such products may not be trans- ered denatured for the purposes of the ported in commerce to any consignee regulations in this part, except as oth- other than the one to which they were erwise provided in part 314 of this sub- originally shipped unless prior notice chapter for articles condemned at offi- of the diversion is given to the appro- cial establishments. priate Regional Director and a record (1) The following agents are pre- identifying the new consignee is main- scribed for denaturing carcasses, parts tained by the shipper as required by thereof, meat or meat food products § 320.1 of this subchapter. which are affected with any condition (3) When transported from an official that would result in their condemna- establishment or in commerce under tion and disposal under part 314 of this this paragraph (e), the outside con- subchapter if they were at an official tainer of such inedible products shall establishment: Crude carbolic acid;

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cresylic disinfectant; a formula con- of this section to the outer surface of sisting of 1 part FD&C green No. 3 molds or blocks of boneless meat, meat coloring, 40 parts water, 40 parts liquid byproducts, or meat food products detergent, and 40 parts oil of citronella, shall not be adequate. The denaturing or other proprietary substance ap- agent must be mixed intimately with proved by the Administrator in specific all of the material to be denatured, and 3 cases. must be applied in such quantity and (2) Except as provided in paragraphs manner that it cannot easily and read- (a)(3), (4), and (5) of this section, the ily be removed by washing or soaking. following agents are prescribed for de- A sufficient amount of the appropriate naturing other carcasses, parts thereof, meat and meat food products, for agent shall be used to give the material which denaturing is required by this a distinctive color, odor, or taste so part: FD&C green No. 3 coloring; FD&C that such material cannot be confused blue No. 1 coloring; FD&C blue No. 2 with an article of human food. coloring; finely powdered charcoal; or (7) Carcasses (other than viscera), other proprietary substance approved parts thereof, cuts of meat, and by the Administrator in specific cases. 3 unground pieces of meat darkened by (3) Tripe may be denatured by dip- charcoal or other black dyes shall be ping it in a 6 percent solution of tannic deemed to be denatured pursuant to acid for 1 minute followed by immer- this section only if they contain at sion in a water bath, then immersing it least that degree of darkness depicted for 1 minute in a solution of 0.022 per- by diagram 1 of the Meat Denaturing cent FD&C yellow No. 5 coloring; Guide (MP Form 91). 1 (4) Meat may be denatured by dipping (b) Inedible rendered animal fats it in a solution of 0.0625 percent tannic shall be denatured by thoroughly mix- acid, followed by immersion in a water ing therein denaturing oil, No. 2 fuel bath, then dipping it in a solution of 0.0625 percent ferric acid; and oil, brucine dissolved in a mixture of (5) When meat, meat byproducts, or alcohol and pine oil or oil of rosemary, meat food products are in ground form, finely powdered charcoal, or any pro- 4 percent by weight of coarsely ground prietary denaturing agent approved for hard bone, which shall be in pieces no the purpose by the Administrator in smaller than the opening size specified specific cases. The charcoal shall be for No. 5 mesh in the standards issued used in no less quantity than 100 parts by the U.S. Bureau of Standards or 6 per million and shall be of such char- percent by weight of coarsely ground acter that it will remain suspended in- hard bone, which shall be in pieces no definitely in the liquid fat. Sufficient smaller than the opening size specified of the chosen identifying agents shall for No. 8 mesh in said Standards, uni- be used to give the rendered fat so dis- formly incorporated with the product tinctive a color, odor, or taste that it may be used in lieu of the agents pre- cannot be confused with an article of scribed in paragraph (a)(2) of this sec- human food. tion. (6) Before the denaturing agents are [35 FR 15605, Oct. 3, 1970, as amended at 41 FR applied to articles in pieces more than 22930, June 8, 1976; 44 FR 67626, Nov. 27, 1979] 4 inches in diameter, the pieces shall be freely slashed or sectioned. (If the articles are in pieces not more than 4 inches in diameter, slashing or sec- 1 Copies of MP Form 91 may be obtained, tioning will not be necessary.) The ap- without charge, by writing to the Adminis- plication of any of the denaturing trative Operations Branch, Food Safety and Inspection Service, U.S. Department of Agri- agents listed in paragraph (a)(1) or (2) culture, 123 East Grant Street, Minneapolis, Minnesota 55403. Diagrams 2 and 3 of the 3 Information as to approval of any propri- Meat Denaturing Guide are for comparison etary denaturing substance may be obtained purposes only. The Meat Denaturing Guide from the Technical Services, Meat and Poul- has been approved for incorporation by ref- try Inspection, Food Safety and Inspection erence by the Director, Office of the Federal Service, U.S. Department of Agriculture, Register, and is on file at the Federal Reg- Washington, DC 20250. ister library.

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§ 325.14 Certificates, retention by car- than a Program employee shall affix, rier. detach, break, change, or tamper with All original certificates delivered to any such seal in any way whatever. a carrier in accordance with this part Commission of any such acts contrary shall be filed separate and apart from to this regulation is a criminal offense. all its other papers and records or iden- § 325.17 Loading or unloading prod- tified in such a manner as to be readily ucts in sealed railroad cars, trucks, checked by Department employees. etc., en route prohibited; exception. Every certificate required to be main- Unloading any product from an offi- tained under this part shall be retained cially sealed railroad car, truck, or for a period of 2 years after December other means of conveyance containing 31 of the year in which the transaction any unmarked product or loading any has occurred. product or any other commodity in the § 325.15 Evidence of proper certifi- means of conveyance while en route cation required on waybills; trans- from one official establishment to an- fer bills, etc., for shipment by con- other official establishment is not per- necting carrier; forms of statement. mitted, except that product trans- (a) All waybills, transfer bills, run- ported under § 325.5 from one official es- ning slips, conductor’s cards, or other tablishment to another for further papers accompanying a shipment, in processing may be unloaded and stored the course of importation or otherwise in transit at any approved warehouse in commerce, of any product shall have which is operated under the identifica- embodied therein, stamped thereon, or tion service provided under the regula- attached thereto a signed statement tions in part 350 of subchapter B of this chapter and which has railroad facili- which shall be evidence to connecting ties or a receiving dock for unloading carriers that the proper shipper’s cer- the product directly into such ware- tificate, as required by § 325.5, § 325.6, or house: Provided, That the product is § 325.7, is on file with the initial carrier. stored in rooms which are of such size No connecting carrier shall receive for and type as will not result in adultera- transportation or transport in the tion or misbranding of the product: course of importation or otherwise in And provided further, That the product commerce any product unless the way- is transported to and from such ware- bill, transfer bill, running slip, conduc- house, and under official seal as pro- tor’s card, or other papers accom- vided in § 325.5 and stored in such panying the same includes the signed rooms at such warehouse. statement in the following form: llllllllllllllllllllllll § 325.18 Diverting of shipments, breaking of seals, and reloading by car- (Name of transportation company) rier in emergency; reporting to Re- U.S. inspected and passed, as evidenced by gional Director. shipper’s certificate on file with initial carrier. (a) Shipments of inspected and passed (signed) lllllllllllllllllll product that bear the inspection legend Agent may be diverted from the original destination without a reinspection of the (b) Signatures of agents to state- articles, provided the waybills, transfer ments required under this section shall bills, running slips, conductor’s card, be written in full. or other papers accompanying the ship- [47 FR 17276, Apr. 22, 1982] ments are marked, stamped, or have attached thereto signed statements in § 325.16 Official seals; forms, use, and accordance with § 325.15. breaking. (b) In case of wreck or similar ex- (a) The official seals required by this traordinary emergency, the Depart- part shall be those prescribed in ment seals on a railroad car or other § 312.5(a) of this subchapter. means of conveyance containing any (b) Except as provided in § 325.18(b), inspected and passed product may be official seal affixed under this part broken by the carrier, and if necessary, shall be affixed or broken only by Pro- the articles may be reloaded into an- gram employees, and no person other other means of conveyance, or the

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shipment may be diverted from the § 325.20 Transportation and other original destination, without another transactions concerning dead, shipper’s certificate; but in all such dying, disabled, or diseased live- cases the carrier shall immediately re- stock, and parts of carcasses of livestock that died otherwise than by port the facts by telephone or tele- slaughter. graph to the Regional Director in the area in which the emergency occurs. No person engaged in the business of Such report shall include the following buying, selling, or transporting in commerce, or importing any dead, dying, information: disabled or diseased animals or parts of (1) Nature of the emergency. the carcasses of any animals that died (2) Place where seals were broken. otherwise than by slaughter shall: (3) Original points of shipment and (a) Buy, sell, transport, or offer for destination. sale or transportation, in commerce, or (4) Number and initial of the original import any dead livestock if its hide or car or truck. skin has been removed; (5) Number and initials of the car or (b) Sell, transport, offer for sale or truck into which the articles are re- transportation, or receive for transpor- loaded. tation, in commerce, any dead, dying, (6) New destination of the shipment. disabled, or diseased livestock, or parts (7) Kind and amount of articles. of the carcasses of any livestock that died otherwise than by slaughter, un- [35 FR 15605, Oct. 3, 1970, as amended at 42 FR less such livestock and parts are con- 39087, Aug. 2, 1977] signed and delivered, without avoidable delay, to establishments of animal food § 325.19 Provisions inapplicable to manufacturers, renderers, or collection specimens for laboratory examina- stations that are registered as required tion, etc., or to naturally inedible by part 320 of this subchapter, or to of- articles. ficial establishments that operate The provisions of this part do not under Federal inspection, or to estab- apply: lishments that operate under a State (a) To specimens of product sent to or Territorial inspection system ap- or by the Department of Agriculture or proved by the Secretary as one that divisions thereof in Washington, DC, or imposes requirements at least equal to elsewhere, for laboratory examination, the Federal requirements for purposes exhibition purposes, or other official of paragraph 301(c) of the Act; 4 use; (c) Buy in commerce or import any (b) To material released for edu- dead, dying, disabled, or diseased live- cational, research and other nonfood stock or parts of the carcasses of any purposes, as prescribed in § 314.9 of this livestock that died otherwise than by subchapter; slaughter, unless he is an animal food manufacturer or renderer and is reg- (c) To glands and organs for use in istered as required by part 320 of this preparing pharmaceutical, subchapter, or is the operator of an es- organotherapeutic, or technical prod- tablishment inspected as required by ucts and not used for human food, as paragraph (b) of this section and such described in § 318.1(g) of this sub- livestock or parts of carcasses are to be chapter; delivered to establishments eligible to (d) To material or specimens of product for laboratory examination, re- 4 A list of such registrants, States, and search, or other nonhuman food pur- amendments thereof, will be published in the poses, when authorized by the Adminis- FEDERAL REGISTER, and information con- trator, and under conditions prescribed cerning the registration status of particular by him in specific cases; and animal food manufacturers, renderers, or (e) To articles that are naturally in- collection stations, or the status of particular States or Territories may also be ob- edible by humans, such as hoofs, horns, tained from the Director, Administrative and hides in their natural state. Management Staff, Food Safety and Inspec- tion Service, U.S. Department of Agri- culture, Washington, DC 20250.

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receive them under paragraph (b) of fluid, parts, or product of such dead, this section; dying, disabled, or diseased livestock (d) Unload en route to any establish- and the thorough application of a dis- ment eligible to receive them under infectant to the interior surfaces of the paragraph (b) of this section, any dead, cargo space. Substances permitted for dying, disabled, or diseased livestock such use are: or parts of the carcasses of any live- (a) ‘‘Liquified phenol’’ (U.S.P. stock that died otherwise than by strength 87 percent phenol) in the pro- slaughter, which are transported in portion of at least 6 fluid ounces to 1 commerce or imported by any such per- gallon of water. son: Provided, That any such dead, (b) ‘‘Cresylic disinfectant’’ in the pro- dying, disabled, or diseased livestock, portion of not less than 4 fluid ounces or parts of carcasses may be unloaded to 1 gallon of water; and such other dis- from a means of conveyance en route infectants as are approved by the Ad- where necessary in case of a wreck or ministrator in specific cases. The use otherwise extraordinary emergency, of ‘‘cresylic disinfectant’’ is permitted and may be reloaded into another subject to the conditions prescribed in means of conveyance; but in all such § 71.10(b) of this title. cases, the carrier shall immediately report the facts by telegraph or tele- PART 327—IMPORTED PRODUCTS phone to the Compliance Staff, Meat and Poultry Inspection Field Oper- Sec. ations, Food Safety and Inspection 327.1 Definitions; application of provisions. Service, U.S. Department of Agri- 327.2 Eligibility of foreign countries for im- culture, Washington, DC 20250. portation of products into the United (e) Load into any means of convey- States. 327.3 No product to be imported without ance containing any dead, dying, dis- compliance with applicable regulations. abled, or diseased livestock, or parts of 327.4 Imported products; foreign certificates the carcasses of any livestock that died required. otherwise than by slaughter, while in 327.5 Importer to make application for in- the course of importation or other spection of products for entry; informa- transportation in commerce any live- tion required; ‘‘streamlined’’ inspection stock or parts of carcasses not within procedures for Canadian product. 327.6 Products for importation; program in- the foregoing description or any other spection, time, and place; application for products or other commodities. approval of facilities as official import [35 FR 15605, Oct. 3, 1970, as amended at 42 FR inspection establishment; refusal or 42309, Aug. 23, 1977] withdrawal of approval; official numbers. 327.7 Products for importation; movement § 325.21 Means of conveyance in which prior to inspection; handling; bond; as- dead, dying, disabled, or diseased sistance. livestock and parts of carcasses 327.8 Import products; equipment and thereof shall be transported. means of conveyance used in handling to be maintained in sanitary condition. All vehicles and other means of con- 327.9 Burlap wrapping for foreign meat. veyance used by persons subject to 327.10 Samples; inspection of consignments; § 325.20 for transporting in commerce or refusal of entry; marking. importing, any dead, dying, disabled, 327.11 Receipts to importers for import and diseased livestock or parts of car- product samples. casses of livestock that died otherwise 327.12 Foreign canned or packaged products bearing trade labels; sampling and in- than by slaughter shall be leak-proof spection. and so constructed and equipped as to 327.13 Foreign products offered for importa- permit thorough cleaning and sani- tion; reporting of findings to customs; tizing. The means of conveyance so handling of articles refused entry. used in conveying such livestock, or 327.14 Marking of products and labeling of parts thereof, shall be cleaned and dis- immediate containers thereof for impor- infected prior to use in the transportation. 327.15 Outside containers of foreign prod- tation of any product intended for use ucts; marking and labeling; application as human food. The cleaning procedure of official inspection legend. shall include the complete removal 327.16 Small importations for importer’s from the means of conveyance of any own consumption; requirements.

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327.17 Returned U.S. inspected and marked tainers or the products themselves if products. not in containers are marked with the 327.18 Products offered for entry and en- Canadian port stamp and upon the filtered to be handled and transported as domestic; exception. ing of Customs Form 7533 at the port of 327.19 Specimens for laboratory examina- entry or at the nearest customhouse in tion and similar purposes. accordance with 19 CFR part 123. 327.20 Importation of foreign inedible fats. (iv) Entry (entered) for product sub- 327.21 Inspection procedures for chilled ject to reinspection. When the con- fresh and frozen boneless manufacturing tainers or the products themselves if meat. not in containers are marked with the 327.22 [Reserved] 327.23 Compliance procedure for cured pork Canadian export stamp and the foreign products offered for entry. inspection certificate accompanying 327.24 Appeals; how made. the product is stamped as ‘‘Inspected 327.25 Disposition procedures for product and Passed’’ by the import inspector. condemned or ordered destroyed under (b) The provisions of this part shall import inspection. apply to products derived from cattle, 327.26 Official import inspection marks and devices. sheep, swine, goats, horses, mules, and other equines, if capable of use as AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.18, human food. Compliance with the con- 2.53. ditions for importation of products SOURCE: 35 FR 15610, Oct. 3, 1970, unless under this part does not excuse the otherwise noted. need for compliance with applicable requirements under other laws, including § 327.1 Definitions; application of provisions. the provisions in parts 94, 95, and 96 of chapter I of this title. (a) When used in this part, the following terms shall be construed to [35 FR 15610, Oct. 3, 1970, as amended at 36 FR mean: 12004, June 24, 1971; 54 FR 41048, Oct. 5, 1989] (1) Import (imported). To bring within the territorial limits of the United § 327.2 Eligibility of foreign countries States whether that arrival is accom- for importation of products into the United States. plished by land, air, or water. (2) For product from eligible coun- (a)(1) Whenever it shall be deter- tries other than Canada: mined by the Administrator that the (i) Offer(ed) for entry. The point at system of meat inspection maintained which the importer presents the im- by any foreign country, with respect to ported product to the Program for rein- establishments preparing products in spection. such country for export to the United (ii) Entry (entered). The point at States, insures compliance of such es- which imported product offered for tablishments and their products with entry receives reinspection and is requirements equivalent to all the in- marked with the offical mark of inspection, building construction stand- spection in accordance with § 327.26 of ards, and all other provisions of the this subchapter. Act and the regulations in this sub- (3) For product from Canada: chapter which are applied to official es- (i) Offer(ed) for entry from establish- tablishments in the United States, and ments participating in the ‘‘stream- their products, and that reliance can be lined’’ inspection procedures. The point placed upon certificates required under at which an official of the Canadian this part from authorities of such for- meat inspection system contacts the eign country, notice of that fact will be Import Field Office for an inspection given by including the name of such assignment. foreign country in paragraph (b) of this (ii) Offer(ed) for entry from non- section. Thereafter, products prepared participating establishments. The in such establishments which are cer- point at which the importer presents tified and approved in accordance with the imported product to the Program paragraph (a)(3) of this section, shall be for reinspection. eligible so far as this subchapter is con- (iii) Entry (entered) for product not cerned for importation into the United subject to reinspection. When the con- States from such foreign country after

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applicable requirements of this sub- (B) Post-mortem inspection of car- chapter have been met. casses and parts thereof at time of (2) The determination of accept- slaughter, performed by veterinarians ability of a foreign meat inspection or other employees or licensees of the system for purposes of this section system under the direct supervision of shall be based on an evaluation of the veterinarians; foreign program in accordance with the (C) Official controls by the national following requirements and procedures: government over establishment con- (i) The system shall have a program struction, facilities, and equipment; organized and administered by the na- (D) Direct and continuous official su- tional government of the foreign coun- pervision of slaughtering and prepara- try. The system as implemented must tion of product, by the assignment of provide standards equivalent to those inspectors to establishments certified of the Federal system of meat inspec- under paragraph (a)(3) of this section, tion in the United States with respect to assure that adulterated or mis- to: branded product is not prepared for ex- (A) Organizational structure and port to the United States; staffing, so as to insure uniform en- (E) Complete separation of establish- forcement of the requisite laws and ments certified under subparagraph (3) regulations in all establishments of this paragraph from establishments throughout the system at which prod- not certified and the maintenance of a ucts are prepared for export to the United States; single standard of inspection and sanitation throughout all certified estab- (B) Ultimate control and supervision by the national government over the lishments; official activities of all employees or (F) Requirements for sanitation at licensees of the system; certified establishments and for sani- (C) The assignment of competent, tary handling of product; qualified inspectors; (G) Official controls over condemned (D) Authority and responsibility of material until destroyed or removed national inspection officials to enforce and thereafter excluded from the estab- the requisite laws and regulations gov- lishment; erning meat inspection and to certify (H) A Hazard Analysis and Critical or refuse to certify products intended Control Point (HACCP) system, as set for export; forth in part 417 of this chapter. (E) Adequate administrative and (I) Other matters for which require- technical support; ments are contained in the Act or regu- (F) The inspection, sanitation, qual- lations in this subchapter. ity, species verification, and residue (iii) Countries desiring to establish standards applied to products produced eligibility for importation of product in the United States. into the United States may request a (G) Other requirements of adequate determination of eligibility by pre- inspection service as required by the senting copies of the laws and regula- regulations in this subchapter. tions on which the foreign meat inspec- (ii) The legal authority for the sys- tion system is based and such other in- tem and the regulations thereunder formation as the Administrator may shall impose requirements equivalent require with respect to matters enu- to those governing the system of meat merated in paragraphs (a)(2) (i) and (ii) inspection organized and maintained in of this section. Determination of eligi- the United States with respect to: bility is based on a study of the docu- (A) Ante-mortem inspection of ani- ments and other information presented mals for slaughter and inspection of and an initial review of the system in methods of slaughtering and handling operation by a representative of the in connection with slaughtering which Department using the criteria listed in shall be performed by veterinarians or paragraphs (a)(2) (i) and (ii) of this sec- by other employees or licensees of the tion. Maintenance of eligibility of a system under the direct supervision of country for importation of products the veterinarians; into the United States depends on the

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results of periodic reviews of the for- in accordance with sampling and ana- eign meat inspection system in oper- lytical techniques approved by the Ad- ation by a representative of the De- ministrator: Provided, That such test- partment, and the timely submission of ing is required only on samples taken such documents and other information from carcasses from which meat or related to the conduct of the foreign meat food products intended for impor- inspection system, including informa- tation into the United States are pro- tion required by paragraph (e) of sec- duced. tion 20 of the Act, as the Administrator (3) Only those establishments that may find pertinent to and necessary for are determined and certified to the De- the determinations required by this partment by a responsible official of section of the regulations. the foreign meat inspection system as (iv) The foreign inspection system fully meeting the requirements of must maintain a program to assure paragraphs (a)(2) (i) and (ii) of this sec- that the requirements referred to in tion are eligible to have their products this section, equivalent to those of the imported into the United States. Eligi- Federal system of meat inspection in bility of certified establishments is the United States, are being met. The subject to review by the Department program as implemented must provide (including observations of the estab- for the following: lishments by Program representatives (A) Periodic supervisory visits by a at times prearranged with the officials representative of the foreign inspection of the foreign meat inspection system). system to each establishment certified Certifications of establishments must in accordance with paragraph (a)(3) of be renewed annually. Notwithstanding this section to ensure that require- certification by a foreign official, the ments referred to in paragraphs Administrator may, at his discretion, (a)(2)(ii)(A) through (H) of this section terminate the eligibility of any foreign are being met: Provided, That such vis- establishment for importation of its its are not required with respect to any products into the United States if he establishment during a period when the has information that such establish- establishment is not operating or is ment does not comply with the require- not engaged in producing products for ments listed in paragraphs (a)(2) (i) and exportation to the United States; (ii) of this section or if he cannot ob- (B) Written reports prepared by the tain current information concerning representative of the foreign inspection such establishment. The Administrator system who has conducted a super- will provide reasonable notice to the visory visit, documenting his or her foreign government of the proposed findings with respect to the require- termination of eligibility of any for- ments referred to in (A) through (H) of eign establishment for importation of its products into the United States un- paragraph (a)(2)(ii) of this section, cop- less, in his judgment, delay in termi- ies of which shall be made available to nating its eligibility could result in the the representative of the Department importation of adulterated or mis- at the time of that representative’s re- branded product. Certifications of offi- view upon request by that representa- cial establishments by the responsible tive to a responsible foreign meat in- official of the foreign meat inspection spection official: Provided, That such system shall be in the following form: reports are not required with respect to any establishment during a period FOREIGN OFFICIAL MEAT ESTABLISHMENT when the establishment is not oper- CERTIFICATE ating or is not engaged in producing I hereby certify that the establishment(s) products for exportation to the United listed below fully comply (complies) with re- States; and quirements of (specify foreign country) (C) Random sampling of internal or- equivalent to all the inspection, building gans and fat of carcasses at the point construction standards, and other require- of slaughter and the testing of such or- ments for the slaughter and preparation of the carcasses, parts thereof, meat and meat gans and fat, for such residues having food products of cattle, sheep, swine, goats, been identified by the exporting coun- and equines applied to official establish- try’s meat inspection authorities or by ments in the United States under the Fed- this Agency as potential contaminants, eral Meat Inspection Act and otherwise meet

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(meets) the requirements of § 327.2(a) of the public, El Salvador, England and Wales, regulations governing meat inspection of the Finland, France, Germany (Federal Repub- U.S. Department of Agriculture. lic), Guatemala, Honduras, Hungary, Ice- land, Ireland (Eire), Italy, Japan, Mexico, Control numbers Name Address Netherlands, New Zealand, Nicaragua, Northern Ireland, Norway, Paraguay, Po- land, Republic of China, (Taiwan), Repub- lic of Croatia, Republic of Slovenia, Roma- nia, San Marino, 1 Scotland, Slovakia, 2 Date lllllllllllllllllllll Spain, Sweden, Switzerland, Uruguay, Ven- Signature ————————————————— ezuela, Yugoslavia. Official Title ——————————————— (c) It has been determined that prod- (4) Product of cattle, sheep, swine, uct of equines from the following coun- and goats from foreign countries not tries, covered by foreign meat inspec- listed in paragraph (b) of this section tion certificates of the country of ori- and product of equines from countries gin as required by § 327.4, is eligible not listed in paragraph (c) of this sec- under the regulations in this sub- tion is not eligible for importation into chapter for importation into the the United States, except as provided United States after inspection and by § 327.16 or § 327.17. The listing of any marking as required by the applicable foreign country under this section may provisions of this part. be withdrawn whenever it shall be determined by the Administrator that Argentina, Canada, New Zealand, Paraguay. the system of meat inspection main- [35 FR 15610, Oct. 3, 1970] tained by such foreign country does EDITORIAL NOTE: For FEDERAL REGISTER ci- not assure compliance with require- tations affecting § 327.2, see the List of CFR ments equivalent to all the inspection, Sections Affected, which appears in the building construction standards, and Finding Aids section of the printed volume other requirements of the Act and the and at www.fdsys.gov. regulations in this subchapter as applied to official establishments in the § 327.3 No product to be imported United States; or that reliance cannot without compliance with applicable be placed upon certificates required regulations. under this part from authorities of (a) No product offered for importa- such foreign country; or that, for lack tion from any foreign country shall be of current information concerning the admitted into the United States if it is system of meat inspection being main- adulterated or misbranded or does not tained by such foreign country, such comply with all the requirements of foreign country should be required to this subchapter that would apply to it reestablish its eligibility for listing. if it were a domestic product. (b) It has been determined that prod- (b) No cooked or partially cooked uct of cattle, sheep, swine, and goats meat or meat trimmings, either in sep- from the following countries covered arable pieces or molded into larger by foreign meat inspection certificates forms, shall be permitted entry except of the country of origin as required by under the following conditions: § 327.4, except fresh, chilled, or frozen (1) A complete procedure for pre- or other product ineligible for importa- paring and handling the product in the tion into the United States from coun- foreign country and en route to the tries in which the contagious and com- United States shall be submitted by municable disease of rinderpest or of the exporter or his authorized agent to foot-and-mouth disease or of African the Administrator and determined by swine fever exists as provided in part 94 the Administrator to be adequate to of this title, is eligible under the regulations in this subchapter for entry 1 Equivalent for processing inspection sys- into the United States after inspection tem only. and marking as required by the appli- 2 May export to the United States only cable provisions of this part. processed meat food products derived from animals slaughtered under Federal inspec- Argentina, Australia, Austria, Belgium, tion in the United States, or in a country eli- Belize, Brazil, Canada, Chile, Costa Rica, gible to export meat and meat products to Czech Republic, Denmark, Dominican Re- the United States.

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assure that the product will not be Species of live- Number of Kind of product stock derived pieces or Weight adulterated or misbranded at the time from containers of offer for entry. (2) A system acceptable to the Ad- ministrator (upon his determination that the system will provide a reliable indication of the kinds and numbers of Identification marks on products and con- microorganisms present) for the micro- tainers llllllllllllllllll biological testing of the finished product shall be installed by the processor, Consignor llllllllllllllllll the product is subjected to such test- Address lllllllllllllllllll ing, and the results thereof are fur- Establishment number lllllllllll nished to the Administrator and are Consignee llllllllllllllllll acceptable to him as showing that the Destination lllllllllllllllll Shipping marks lllllllllllllll product has been prepared and handled (Signature) lllllllllllllllll in a sanitary manner. (Name of official authorized by the national (c) [Reserved] foreign government to issue inspection cer- [35 FR 15610, Oct. 3, 1970, as amended at 38 FR tificates for meat and meat byproducts ex- 29215, Oct. 23, 1973; 54 FR 41048, Oct. 5, 1989; 56 ported to the United States) FR 38335, Aug. 13, 1991; 57 FR 27906, June 23, (Official title) llllllllllllllll 1992] (b) Except as provided in § 327.16, each consignment containing any meat food § 327.4 Imported products; foreign certificates required. product consigned to the United States from a foreign country shall be accom- (a) Except as provided in § 327.16, each panied by a foreign-meat-inspection consignment containing any fresh certificate for meat food products in meat or fresh meat byproducts con- the following form: signed to the United States from a foreign country shall be accompanied by a ORIGINAL foreign-meat-inspection certificate for fresh meat and meat byproducts in the OFFICIAL MEAT-INSPECTION CERTIFICATE FOR MEAT FOOD PRODUCTS following form: Place llllll (City) llllll (Coun- ORIGINAL try) llllll Date lll

OFFICIAL MEAT-INSPECTION CERTIFICATE FOR I hereby certify that the meat food prod- FRESH MEAT AND MEAT BYPRODUCTS ucts herein described were derived from livestock which received ante-mortem and post- Place llllll (City) llllll (Coun- mortem veterinary inspections at time of try) Date lll slaughter in plants certified for importation I hereby certify that the meat and meat of their products into the United States, byproducts herein described were derived were handled in a sanitary manner, and were from livestock which received ante-mortem prepared under the continuous supervision of and post-mortem veterinary inspections at an inspector under control of the national time of slaughter in plants certified for im- meat inspection system and that said meat portation of their products into the United food products are not adulterated or mis- States and are not adulterated or misbranded as defined by the regulations gov- branded as defined by the regulations governing meat inspection of the U.S. Depart- erning meat inspection of the U.S. Depart- ment of Agriculture, and are otherwise in ment of Agriculture; and that said products compliance with requirements equivalent to have been handled in a sanitary manner in those in the Federal Meat Inspection Act and this country and are otherwise in compliance said regulations. with requirements equivalent to those in the I further certify that all products herein Federal Meat Inspection Act and said regula- described that are prepared customarily to tions. be eaten without cooking and contain muscle tissue of pork were treated for destruc- Species of live- Number of Kind of product stock derived pieces or Weight tion of trichnae as prescribed in § 318.10 of from containers the Meat Inspection Regulations of the U.S. Department of Agriculture.

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Species of live- Number of Import Field Office will provide spe- Kind of product stock derived pieces or Weight from containers cific application instructions (See § 301.2 (yyy)). (b) The application should be made as long as possible in advance of the anticipated arrival of each consignment, except in case of consignments of prod- Identification marks on products and con- ucts expressly exempted from inspec- tainers llllllllllllllllll tion by §§ 327.16 and 327.17, and in the case of product imported from Canada. Consignor llllllllllllllllll (c) Except in the case of product im- Address lllllllllllllllllll Establishment number lllllllllll ported from Canada, each application Consignee llllllllllllllllll shall state the approximate date on Destination lllllllllllllllll which the consignment is due to arrive Shipping marks lllllllllllllll at such port in the United States, the (Signature) lllllllllllllllll name of the ship or other carrier trans- (Name of official authorized by the national foreign government to issue inspection cer- porting it, the name of the country tificates for meat food product exported to from which the product was, or is to the United States) be, shipped, the place where inspection (Official title) llllllllllllllll is desired in accordance with § 327.6, the (c) Each foreign meat-inspection cer- quantity and kind of product, and tificate shall bear the official seal of whether it is fresh, cured, canned or the national government agency re- otherwise prepared. In case of consign- sponsible for the inspection of the ments arriving in the United States by product and be signed and issued by an water, the application shall also state official authorized to sign and issue the port of first arrival in the United such certificates by the national gov- States. ernment of the foreign country in (d) For participating Canadian estab- which the product is inspected. lishments, an official of the Canadian (d) Each foreign meat-inspection cer- meat inspection system shall contact tificate shall be in both the English the participating Import Field Office language and the language of the for- for an inspection assignment (See eign country of origin. (e) Except for product subject to pro- § 301.2 (yyy)). cedures in § 327.5(d)(l), the foreign meat (1) If the Automated Import Informa- inspection certificate required by this tion System (AIIS) does not designate section to accompany each consign- the consignment for reinspection, the ment containing any product shall be consignment may be transported to its delivered by the consignee, or his consignee for further distribution. agent, in the United States to the Pro- (2) If the AIIS designates the consign- gram import inspector at the place of ment for reinspection, the representa- inspection, and inspection of the prod- tive shall: uct will not be commenced prior to (i) Select samples in accordance with such delivery. USDA sampling tables. 3 [35 FR 15610, Oct. 3, 1970, as amended at 54 FR (ii) Identify and place samples in the 274, Jan. 5, 1989; 60 FR 38668, July 28, 1995] vehicle for easy removal and reinspection by an import inspector. § 327.5 Importer to make application for inspection of products for entry; (3) In the event that any one of the information required; ‘‘streamlined’’ requirements provided in (d)(2) of this inspection procedures for Canadian section is not met, reinspection of the product. consignment shall be conducted by a (a) Except for importers of Canadian products, each importer shall apply for inspection of any product offered for 3 A copy of the sampling tables is available, entry by contacting the Import Field upon request, from the Import Inspection Di- vision, International Programs, Food Safety Office covering the location where im- and Inspection Service, U.S. Department of port inspection will take place. The Agriculture, Washington, DC 20250.

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Program import inspector in accord- ments, who want to have import in- ance with established procedures pro- spections made at their establish- vided in the regulations for other im- ments, shall apply to the Adminis- ported products. trator for approval of their establish- [54 FR 274, Jan. 5, 1989, as amended at 54 FR ments for such purpose. Application 41048, Oct. 5, 1989] shall be made on a form furnished by the Program, Food Safety and Inspec- § 327.6 Products for importation; pro- tion Service, U.S. Department of Agri- gram inspection, time and place; culture, Washington, DC, and shall in- application for approval of facilities clude all information called for by that as official import inspection estab- form. lishment; refusal or withdrawal of (d) Approval for Federal import in- approval; official numbers. spection shall be in accordance with (a)(1) Except as provided in part 304 of this subchapter. §§ 327.5(d)(1), 327.16 and 327.17, all prod- (e) Owners or operators of establish- ucts offered for entry from any foreign ments at which import inspections of country shall be reinspected by a Pro- product are to be made shall furnish gram inspector before they shall be al- adequate sanitary facilities and equip- lowed entry into the United States. ment for examination of such product. (2) Every lot of product shall rou- The requirements of §§ 304.2(e), 307.1, tinely be given visual inspection by a 307.2 (b), (d), (f), (h), (k), and (l) and Program import inspector for appear- 416.1 through 416.6 of this chapter shall ance and condition, and checked for apply as conditions for approval of es- certification and label compliance, ex- tablishments as official import inspec- cept as provided in 327.5(d)(1). tion establishments to the same extent (3) The computerized Automated Im- and in the same manner as they apply port Information System (AIIS) shall with respect to official establishments. be consulted for reinspection instruc- (f) The Administrator is authorized tions. The AIIS will assign reinspection to approve any establishment as an of- levels and procedures based on estab- ficial import inspection establishment lished sampling plans or established provided that an application has been sampling plans and established product filed and drawings have been submitted and plant history. in accordance with the requirements of (4) When the inspector deems it nec- paragraphs (c) and (d) of this section essary, the inspector may sample and and he determines that such establish- inspect lots not designated by AIIS. (b) All products, required by this part ment meets the requirements under to be inspected, shall be inspected only paragraph (e) of this section. Any ap- at an official establishment or at an of- plication for inspection under this sec- ficial import inspection establishment tion may be denied or refused in ac- approved by the Administrator as pro- cordance with the rules of practice in vided in this section. Such approved of- part 500 of this chapter. ficial import inspection establishments (g) Approval of an official import in- will be listed in the Directory of Meat spection establishment may be with- and Poultry Inspection Program Estab- drawn in accordance with applicable lishments, Circuits and Officials, pub- rules of practice if it is determined lished by the Food Safety and Inspec- that the sanitary conditions are such tion Service. The listing will cat- that the product is rendered adulter- egorize the kind or kinds of product 2 ated, that such action is authorized by which may be inspected at each official section 21(b) of the Federal Water Pol- import inspection establishment, based lution Control Act, as amended (84 on the adequacy of the facilities for Stat. 91), or that the requirements of making such inspections and handling paragraph (e) of this section were not such products in a sanitary manner. complied with. Approval may also be (c) Owners or operators of establish- withdrawn in accordance with section ments, other than official establish- 401 of the Act and applicable rules of practice. 1 [Reserved] (h) A special official number shall be 2 For example: Canned product, boneless assigned to each official import inspec- meat, carcasses and cuts. tion establishment. Such number shall

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be used to identify all products in- shall be incubated under supervision of spected and passed for entry at the es- such inspectors in accordance with tablishment. § 318.309 (d)(1)(ii), (d)(1)(iii), (d)(1)(iv)(c), (i) A sampling inspection shall be (d)(1)(v), (d)(1)(vii) and (d)(1)(viii) of made, as provided in paragraph (a) of this subchapter. The importers or his/ this section, of foreign chilled fresh or her agent shall provide the necessary frozen fresh meat, including defrosting incubation facilities in accordance if necessary to determine its condition. with § 318.309(d)(1)(i) of this subchapter. Inspection standards for foreign chilled (m) Sampling plans and acceptance fresh or frozen fresh meat shall be the levels as prescribed in paragraphs (j) same as those used for domestic chilled and (l) of this section may be obtained, fresh or frozen fresh meat. (See § 327.21) upon request, from International Pro- (j) Imported canned products are re- grams, Food Safety and Inspection quired to be sound, healthful, properly Service, U.S. Department of Agri- labeled, wholesome, and otherwise not culture, Washington, DC 20250. adulterated at the time the products [35 FR 15610, Oct. 3, 1970, as amended at 37 FR are offered for importation into the 21927, Oct. 17, 1972; 38 FR 29215, Oct. 23, 1973; United States. Provided other require- 49 FR 36818, Sept. 20, 1984; 51 FR 37707, Oct. ments of this part are met, the deter- 24, 1986; 51 FR 45633, Dec. 19, 1986; 54 FR 274, mination of the acceptability of the Jan. 5, 1989; 54 FR 41048, Oct. 5, 1989; 62 FR product and the condition of the con- 45026, Aug. 25, 1997; 64 FR 56416, Oct. 20, 1999; tainers shall be based on the results of 64 FR 66545, Nov. 29, 1999; 65 FR 2284, Jan. 14, an examination of a statistical sample 2000] drawn from the consignment as provided in paragraph (a) of this section. If § 327.7 Products for importation; movement prior to inspection; han- the inspector determines, on the basis dling; bond; assistance. of the sample examination, that the product does not meet the require- (a) No product required by this part ments of the Act and regulations there- to be inspected shall be moved, prior to under, the consignment shall be reinspection from any port, or, if arriv- fused entry. However, a consignment ing by water from the wharf where first rejected for container defects but oth- unloaded, to any place other than the erwise acceptable may be reoffered for place designated by, or in accordance inspection under the following condi- with, this part as the place where the tions: same shall be inspected. (1) If the defective containers are not (b) No product required by this part indicative of an unsafe and unstable to be inspected shall be conveyed, prior product as determined by the Adminis- to inspection, from any port, or, if ar- trator; riving by water, from the wharf where (2) If the number and kinds of con- first unloaded, in any manner other tainer defects found in the original than in compliance with this part. sample do not exceed the limits speci- (c) No product required by this part fied for this purpose in FSIS guide- to be inspected shall be delivered to lines; and the consignee or his agent prior to in- (3) If the defective containers in the spection, unless the consignee shall consignment have been sorted out and furnish a bond, in form prescribed by exported or destroyed under the super- the Secretary of the Treasury, condi- vision of an inspector. tioned that the product shall be re- (k) Program inspectors or Customs turned, if demanded, to the collector of officers at border or seaboard ports the port where the same is offered for shall report the sealing of cars, trucks, clearance through the customs. or other means of conveyance, and the (d) The consignee or his agent shall sealing or identification of containers provide such assistance as Program in- of foreign product on Form MP–410 to spectors may require for the handling Program area supervisors at points and marking of product offered for where such product is to be inspected. entry. (l) Representative samples of canned [35 FR 15610, Oct. 3, 1970, as amended at 37 FR product designated by the Adminis- 21928, Oct. 17, 1972; 51 FR 37707, Oct. 24, 1986; trator in instructions to inspectors 56 FR 65180, Dec. 16, 1991]

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§ 327.8 Import products; equipment container or the product itself if not in and means of conveyance used in a container. handling to be maintained in sani- (d) The inspection legend may be tary condition. placed on containers of product before Compartments of steamships, sailing completion of official import inspec- vessels, railroad cars, and other means tion if the containers are being in- of conveyance transporting any prod- spected by an import inspector who re- uct to the United States, and all ports directly to an Import Field Office trucks, chutes, platforms, racks, ta- Supervisor; the product is not required bles, tools, utensils, and all other de- to be held at the establishment pending vices used in moving and handling any the receipt of laboratory test results; product offered for importation into and a written procedure for controlled the United States, shall be maintained stamping, submitted by the import es- in a sanitary condition. tablishment and approved by the Direc- tor, Import Inspection Division, is on § 327.9 Burlap wrapping for foreign file at the import inspection facility meat. where the inspection is to be per- Burlap shall not be used as a wrap- formed. ping for foreign meat unless the meat (1) The written procedure for con- is first wrapped with a good grade of trolled pre-stamping should be in the paper or cloth of a kind which will pre- form of a letter and shall include the vent contamination with lint or other following: foreign material. (i) That stamping under this part will be limited to those lots of product § 327.10 Samples; inspection of con- which can be inspected on the day that signments; refusal of entry; mark- certificates for the product are exam- ing. ined; (a) Program inspectors may take, (ii) That all product which has been without cost to the United States, for pre-stamped will be stored in the facil- laboratory examination, samples of ity where the import inspection will any product which is subject to anal- occur; ysis, from each consignment offered for (iii) That inspection marks applied importation, except that such samples under this part will be removed from shall not be taken of any product of- any lot of product subsequently refused fered for importation under § 327.16. entry on the day the product is re- (b) Except for product offered for jected; and entry from Canada, the outside con- (iv) That the establishment will tainers of all products offered for entry maintain a daily stamping log con- from any foreign country and accom- taining the following information for panied with a foreign inspection cer- each lot of product: the date of inspec- tificate as required by this part, which, tion, the country of origin, the foreign upon reinspection by import inspectors establishment number, the product are found not to be adulterated or mis- name, the number of units, the ship- branded and are otherwise eligible for ping container marks, and the MP–410 entry into the United States under this number covering the product to be in- part, or the products themselves if not spected. The daily stamping log must in containers, shall be marked with the be retained by the establishment in ac- official inspection legend prescribed in cordance with the requirements of § 327.26 of this part. Except for Cana- § 320.3. dian product, all other products so (2) An establishment’s controlled pre- marked, in compliance with this part, stamping privilege may be cancelled shall be entered into the United States, orally or in writing by the inspector insofar as such entry is regulated who is supervising its enforcement under the Act. whenever the inspector finds that the (c) Product which is inspected and re- establishment has failed to comply jected shall be marked ‘‘U.S. Refused with the provisions of this part or any Entry’’ as shown in § 327.26(c). Such conditions imposed pursuant thereto. If marks shall be applied to the shipping the cancellation is oral, the decision

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and the reasons therefor shall be con- have not been approved under § 317.3 of firmed in writing, as promptly as cir- this subchapter shall be collected and cumstances allow. Any person whose forwarded to the laboratory by the controlled pre-stamping privilege has Program inspector for examination, been cancelled may appeal the decision and the products shall be held pending to the Administrator, in writing, with- receipt of the report of the laboratory in ten (10) days after receiving written findings and the results of the exam- notification of the cancellation. The ination of trade labels and the marks appeal shall state all of the facts and on shipping containers. reasons upon which the person relies to (b) Foreign canned or packaged prod- show that the controlled pre-stamping ucts bearing trade labels and other privilege was wrongfully cancelled. The markings which have been approved Administrator shall grant or deny the under § 317.3 of this subchapter shall be appeal, in writing, stating the reasons inspected for soundness and checked for such decision, as promptly as cir- for net weight. Samples may be col- cumstances allow. If there is a conflict lected for laboratory examination, but as to any material fact, a hearing shall the products may be released under be held to resolve such conflict. Rules customs’ bond pending the report of of practice concerning such a hearing laboratory findings. will be adopted by the Administrator. (c) Samples shall be taken from for- The cancellation of the controlled pre- eign canned products or packaged prod- stamping privilege will be in effect ucts as required by § 327.6 (a) and (j) of until there is a final determination of this part. the proceeding. [35 FR 15610, Oct. 3, 1970, as amended at 49 FR (Approved by the Office of Management and 36818, Sept. 20, 1984] Budget under control number 0583–0015) § 327.13 Foreign products offered for [35 FR 15610, Oct. 3, 1970, as amended at 53 FR importation; reporting of findings 17014, May 13, 1988; 54 FR 41048, Oct. 5, 1989] to customs; handling of articles refused entry. § 327.11 Receipts to importers for import product samples. (a)(1) Program inspectors shall report their findings as to any product which In order that importers may be as- has been inspected in accordance with sured that samples of foreign products this part, to the Director of Customs at collected for laboratory examination the original port of entry where the are to be used exclusively for that pur- same is offered for clearance through pose, official receipts shall be issued Customs inspection. and delivered to importers, or their (2) When product has been identified agents, by inspectors for all samples of as ‘‘U.S. refused entry, ’’ the inspector foreign products collected. The official shall request the Director of Customs receipt shall be prepared in duplicate, to refuse admission to such product over the signature of the inspector who and to direct that it be exported by the collects the samples, and shall show owner or consignee within the time the name of the importer, country of specified in this section, unless the origin, quantity and kind of product owner or consignee, within the speci- collected, date of collection, and that fied time, causes it to be destroyed by the sample was collected for laboratory disposing of it under the supervision of examination. The duplicate copy of the a Program employee so that the prod- receipt shall be retained by the inspec- uct can no longer be used as human tors as their office record. food, or by converting it to animal food [35 FR 15610, Oct. 3, 1970, as amended at 51 FR uses, if permitted by the Food and 37707, Oct. 24, 1986] Drug Administration. The owner or consignee of the refused entry product § 327.12 Foreign canned or packaged shall not transfer legal title to such products bearing trade labels; sam- product, except to a foreign consignee pling and inspection. for direct and immediate exportation, (a) Samples of foreign canned or or to an end user, e.g., an animal food packaged products bearing on their im- manufacturer or a renderer, for de- mediate containers trade labels which struction for human food purposes.

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‘‘Refused entry’’ product must be deliv- and fees, storage, and proper expense in ered to and used by the manufacturer the appropriate legal forum. or renderer within the 45-day time (7) No product which has been refused limit. Even if such title is illegally entry and exported to another country transferred, the subsequent purchaser pursuant to paragraph (a)(2) of this sec- will still be required to export the tion may be returned to the United product or have it destroyed as speci- States under any circumstance. Any fied in the notice under paragraph such product so returned to the United (a)(5) of this section. States shall be subject to administra- (3) No lot of product which has been tive detention in accordance with sec- refused entry may be subdivided during tion 402 of the Act and seizure and con- disposition pursuant to paragraph demnation in accordance with section (a)(2) of this section, except that re- 403 of the Act. moval and destruction of any damaged (b) Upon the request of the Director or otherwise unsound product from a of Customs at the port where a product lot destined for reexportation is per- is offered for clearance through the mitted under supervision of USDA customs, the consignee of the product prior to exportation. Additionally, shall, at the consignee’s own expense, such refused entry lot may not be immediately return to the Director shipped for export from any port other any product which has been delivered than that through which the product to consignee under § 327.7 and subse- came into the United States, without quently designated ‘‘U.S. Refused the expressed consent of the Adminis- Entry’’ or found in any respect not to trator based on full information con- comply with the requirements in this cerning the product’s disposition, in- part. cluding the name of the vessel and the (c) All charges for storage, cartage, date of export. For the purposes of this and labor with respect to any product paragraph, the term ‘‘lot’’ shall refer which was imported contrary to the to that product indentified on MP Act shall be paid by the owner or con- Form 410 in the original request for in- signee, and in default of such payment spection for importation pursuant to shall constitute a lien against such § 327.5. product and any other product there- (4) Product which has been refused after imported by or for such owner or entry solely because of misbranding, in consignee. lieu of exportation or destruction pur- [35 FR 15610, Oct. 3, 1970, as amended at 48 FR suant to paragraph (a)(2) of this sec- 15889, Apr. 13, 1983; 49 FR 29568, July 23, 1984; tion, may be brought into compliance 50 FR 19907, May 13, 1985; 53 FR 17015, May 13, with the requirements of this part, 1988; 54 FR 50735, Dec. 11, 1989] under supervision of an authorized representative of the Administrator. § 327.14 Marking of products and la- (5) The owner or consignee shall have beling of immediate containers 45 days after notice is given by FSIS to thereof for importation. the Director of Customs at the original (a) Product which is offered for import of entry to take the action re- portation, and which is susceptible of quired in paragraph (a)(2) of this sec- marking, shall, whether or not en- tion for ‘‘refused entry’’ product. Ex- closed in an immediate container, bear tension beyond the 45-day period may the name of the country of origin, pre- be granted by the Administrator when ceded by the words ‘‘product of’’; the extreme circumstances warrant it; e.g., establishment number assigned by the a dock workers’ strike or an unforesee- foreign meat inspection system and able vessel delay. certified to the Program; and such (6) If the owner or consignee fails to other markings as are necessary for take the required action within the compliance with part 316 of this sub- time specified under paragraph (a)(5) of chapter. When such markings are im- this section, the Department will take prints of stamps or brands made with such action as may be necessary to ef- branding ink, such ink shall be harm- fectuate its order to have the product less and shall create permanent im- destroyed for human food purposes. prints. In case the name of the country The Department shall seek court costs of origin appears as part of an official

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mark of the national foreign govern- mitted for approval, provided the ment and such name is prominently markings made by such articles are ap- and legibly displayed, the words plicable to the product and are not ‘‘product of’’ may be omitted. false or misleading. (b) In addition to the marking of products required under paragraph (a) [35 FR 15610, Oct. 3, 1970, as amended at 51 FR of this section, the immediate con- 37707, Oct. 24, 1986; 60 FR 67456, Dec. 29, 1995] tainer of any product offered for impor- § 327.15 Outside containers of foreign tation: products; marking and labeling; ap- (1) Shall bear a label showing in ac- plication of official inspection leg- cordance with § 317.2 of this subchapter end. all information required by that section (except that the establishment (a) The outside container in which number assigned by the foreign meat any immediate container of foreign inspection system and certified to the product is shipped to the United States Program and the official inspection shall bear, in English, in a prominent mark of the foreign meat inspection and legible manner: system shall be shown instead of the (1) The name or descriptive designa- official inspection legend of the United tion of the product in accordance with States) and in addition the name of the § 317.2 of this subchapter; country of origin preceded by the (2) The name of the country of origin; words ‘‘product of,’’ immediately under and the name or descriptive designation of (3) The establishment number as- the product as required by § 317.2: Pro- signed by the foreign meat inspection vided, That such establishment number system and certified to the Program. may be omitted from a label (b) All labeling used with an outside lithographed directly on a can if said container of foreign product must be number is lithographed or embossed approved in accordance with part 317 of elsewhere on the can; and (2) Shall, if such immediate con- this subchapter. tainer is a sealed metal container, have (c) Except for product offered for the establishment number assigned by entry from Canada, all outside con- the foreign meat inspection authority tainers of products which have been in- and certified by the Program embossed spected and passed in accordance with or lithographed on the sealed metal this part shall be marked by a Program container, and such establishment import inspector or under a Program number shall not be covered or ob- import inspector’s supervision with the scured by any label or other means. official import meat inspection mark (c) All marks and other labeling for prescribed in § 327.26. use on or with immediate containers, as well as private brands on carcasses [35 FR 15610, Oct. 3, 1970, as amended at 51 FR 37707, Oct. 24, 1986; 54 FR 41048, Oct. 5, 1989] or parts of carcasses, shall be approved by the Food Safety and Inspection § 327.16 Small importations for import- Service in accordance with part 317 of er’s own consumption; require- this subchapter before products bearing ments. such marks, labeling, or brands will be entered into the United States. The Any product in a quantity of 50 marks of inspection of foreign systems pounds or less which was purchased by embossed on metal containers or the importer outside the United States branded on carcasses or parts thereof for his/her own consumption, is eligible need not be submitted to the Food to be imported into the United States Safety and Inspection Service for ap- from any country without compliance proval, and such marks of inspection with the provisions in other sections of put on stencils, box dies, labels, and this part but subject to applicable re- brands may be used on such immediate quirements under other laws, including containers as tierces, barrels, drums, the regulations in part 94 of this title. boxes, crates, and large-size fiberboard However, Program employees may in- containers of foreign products without spect any product imported under this such marks of inspection being subsection to determine whether it is

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within the class eligible to be imported including requirements of denaturing under this paragraph. or other identification to deter their use for human food. Authorization will [54 FR 41048, Oct. 5, 1989] not be given for the importation of any § 327.17 Returned U.S. inspected and products contrary to the provisions of marked products. part 94 of this chapter. U.S. inspected and passed and so § 327.20 Importation of foreign ined- marked products exported to and re- ible fats. turned from foreign countries will be No inedible grease, inedible tallow, admitted into the United States with- or other inedible rendered fat shall be out compliance with this part upon no- imported into the United States unless tification to and approval of the Dep- it has been first denatured as pre- uty Administrator, International Pro- scribed in § 327.25 of this part and the grams, Food Safety and Inspection containers marked as prescribed by Service, U.S. Department of Agri- § 316.15 of this subchapter or unless it is culture, Washington, DC 20250, in spe- identified and handled as prescribed by cific cases. § 325.11 (b) or (c) of this subchapter. [35 FR 15610, Oct. 3, 1970, as amended at 51 FR [54 FR 41049, Oct. 5, 1989] 37707, Oct. 24, 1986] § 327.21 Inspection procedures for § 327.18 Products offered for entry and chilled fresh and frozen boneless entered to be handled and trans- manufacturing meat. ported as domestic; exception. (a) Definitions; sampling; standards. (1) (a) All products, after entry into the Frozen boneless manufacturing meat is United States, shall be deemed and meat, frozen in the fresh state from treated as domestic products and shall cattle, sheep, swine, goats, horses, be subject to the applicable provisions mules, or other equines that has all of the Act and the regulations in this bone removed and is cut into pieces or subchapter and the applicable require- trimmings, frozen into a compact ments under the Federal Food, Drug block of any shape and suitable for and Cosmetic Act, except that products slicing or chopping in the manufac- imported under § 327.16 are required to turing of meat food products. As used comply only with the requirements of in this section, the term ‘‘frozen’’ in- that Act and § 327.16 of this subchapter. cludes ‘‘chilled fresh,’’ and ‘‘lot’’ means (b) Products entered in accordance any amount of frozen boneless manu- with this part may, subject to the pro- facturing meat of one species, simi- visions of part 318 of this subchapter, larly packaged, shipped from one es- be taken into official establishments tablishment, and offered for import in- and be mixed with or added to any spection under one or more foreign in- product in such establishments which spection certificates. has been inspected and passed therein. (2) Imported frozen boneless manu- (c) Imported product which has been facturing meat shall be sampled as reinspected, passed, and marked under quired by § 327.6(a) of this part, and the this part may be transported in the samples defrosted for inspection. The course of importation or subsequently Program import inspector, or in the in commerce only upon compliance case of Canadian product subject to with part 325 of this subchapter. procedures described in § 327.5(d)(1), the [35 FR 15610, Oct. 3, 1970, as amended at 41 FR Canadian representative will select 18089, Apr. 30, 1976; 54 FR 41049, Oct. 5, 1989] from a lot the appropriate number of cartons specified by the table of sam- § 327.19 Specimens for laboratory ex- pling plans. The total sample for in- amination and similar purposes. spection will consist of the necessary The provisions in this part do not number of 12-pound units drawn from apply to specimens of products for lab- these cartons. The 12-pound units se- oratory examination, research, or simi- lected will be completely defrosted and lar purposes when authorized importa- examined. tion by the Administrator under condi- (b) Lots refused entry. Reinspection tions specified by him in specific cases, (including resampling) will be provided

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for any lot of frozen boneless manufac- pressed as a percent of the non-fat por- turing meat which was refused entry tion of the finished product. under this section on the basis of the (4) A PFF Standardized Difference is original evaluation of the sample the PFF of the sample minus the min- thereof, upon appeal from the inspec- imum PFF requirement, set forth in tor’s initial decision. § 319.104 and § 319.105 of this subchapter, for the product being analyzed, divided [35 FR 15610, Oct. 3, 1970, as amended at 49 FR 36819, Sept. 20, 1984; 51 FR 44901, Dec. 15, 1986; by the Appropriate Standard Deviation 54 FR 275, Jan. 5, 1989; 57 FR 27906, June 23, for the product group. 1992] (5) The Absolute Minimum PFF Re- quirement is that no laboratory result § 327.22 [Reserved] of an individual sample for PFF content be below the applicable minimum § 327.23 Compliance procedure for requirement of § 319.104 or § 319.105 of cured pork products offered for this subchapter by 2.3 or more percent- entry. age points for a Group I or II product (a) Definitions. For the purposes of or 2.7 or more percentage points for a this section: Group III or IV product. (1) A Product is that cured pork arti- (6) A PFF Standardized Arithmetic Av- cle which is contained within one erage of the Country’s Products is the Group as defined in paragraph (a)(2) of arithmetic average of PFF Standard- this section and which purports to ized Differences from either 36 or 100 meet the criteria for a single product consecutively sampled lots of product designated under the heading ‘‘Product entering the United States from a Name and Qualifying Statements’’ in given producing country. the chart in § 319.104 or § 319.105 of this (7) A PFF Standardized Weighted Aver- subchapter. age of the Country’s Products is an esti- (2) A Product Group or a Group means mate of the average of the PFF Stand- one of the following: ardized Differences from either 36 or (i) Group I, consisting of cured pork 100 consecutively sampled lots, ad- products which have been cooked while justed for the size of the lot, of dif- imperviously encased. Any product ferent types of cured pork product en- that fits into the Group shall be placed tering the United States from a given in this Group regardless of any other producing country. A Standardized considerations. Weighted Average is computed by mul- (ii) Group II, consisting of cured pork tiplying the PFF Standardized Dif- products which have been water ference calculated for each lot by the cooked. Any product that does not fit number of pounds of product in each into Group I but does fit into Group II lot, adding those results together, and shall be placed into Group II regardless dividing the sum by the total weight of of any other considerations. product from all the lots making up (iii) Group III, consisting of boneless, the average. smokehouse heated cured pork prod- (8) The Appropriate Standard Deviation ucts. Any boneless product that does is based on within lot variability. That not fit into Group I or II shall be assigned to Groups I and II = 0.75 per- placed in Group III. cent PFF and that assigned to Groups (iv) Group IV, consisting of bone-in III and IV = 0.91 percent PFF. or semi-boneless smokehouse heated (9) A Lot is all product of one type cured pork products. Any product that from one establishment presented by is not completely boneless or still con- an importer as the unit for inspection tains all the bone which is traditional at the Port of Entry. for bone-in product and does not fit (b) Normal monitoring procedures. Ex- into Group I, II, or III shall be placed cept for product imported from Canada, in this Group. the Department shall collect sample(s) (3) Protein Fat-Free Percentage, Protein of cured pork product on a random Fat-Free Content, PFF Percentage, PFF basis from lots offered for entry at the Content or PFF of a product means the Port of Entry and, after analyzing the meat protein (indigenous to the raw, sample for fat and indigenous protein unprocessed pork cut) content ex- content, calculate the PFF percentage.

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The product shall not be held pending lots falls below the upper 95 percent of laboratory results during the moni- the Normal distribution, all available toring phase. The PFF percentage for cured pork product from the foreign each sample shall be considered along country shall be subject to administra- with the cumulative results of prior tive retention and all subsequently pre- samples to assess the effectiveness of a sented lots of cured pork product from country’s overall compliance program the foreign country shall be held under and to determine the course of action retention until the provisions of para- for subsequent lots of product. graph (c) are satisfied. The country of (1) Factors determining whether a origin shall be notified, and shall be country’s inspection system is func- subject to other actions pursuant to tioning adequately: the Act. (i) The PFF percentage for each sam- (c) Retention. When lots of cured pork ple must not be below the minimum product are under retention they shall PFF requirement by 2.3 percentage be refused entry and reexported in ac- points for cured pork products in cordance with § 327.13 of this sub- Groups I and II or 2.7 percentage points chapter unless they can be released in for cured pork products in Groups III accordance with the provisions of para- and IV. graph (c)(1), establishments may be re- (ii) Both of the PFF Standardized turned to normal monitoring proce- Averages, Arithmetic and Weighted, dures in accordance with paragraph for the last 100 consecutive lots of all (c)(2), and countries may be returned to cured pork products from the country normal monitoring procedures in ac- must be equal to or greater than zero. cordance with paragraph (c)(3). The count for the 100 consecutive lots (1) If a lot is subject to retention pro- starts with the lots arriving from that cedures under this section, the Depart- country after April 15, 1985. ment shall collect five randomly se- (iii) Both of the PFF Standardized lected sample units from each lot and Averages, Arithmetic and Weighted, determine the PFF of each sample for the last 36 consecutive lots of all unit. The lot may be released into com- cured pork products from the country merce if: must be above the lowest 5 percent of the Normal distribution. This min- (i) The average PFF percentage of imum value is minus 0.28 (¥0.28) for the five randomly selected sample the Arithmetic Average and depends on units is equal to or greater than the the production volume for the Weight- applicable minimum PFF percentage ed Average. required by § 319.104 or § 319.105 of this (2) Actions when calculations indi- subchapter, or cate that processing procedures in a (ii) The product is relabeled under country are out-of-compliance: the supervision of a program employee (i) If the PFF level of a sample taken so that it conforms to the provisions of during normal monitoring procedures § 319.104 or § 319.105 of this subchapter. is found to be as low as the Absolute (2) If product from a foreign estab- Minimum PFF Requirement, the coun- lishment is subject to retention proce- try of origin shall be notified; the lot dures under this section, the foreign es- involved shall be retained if still avail- tablishment may be returned to nor- able in an official establishment or mal monitoring procedures when: subject to detention or other actions (i) Ten consecutively presented lots pursuant to the Act; and all subse- of that cured pork product from that quently presented lots of that cured establishment have been sampled as pork product from the same foreign es- provided in paragraph (c)(1) of this sec- tablishment shall be held under retention and the average of each set of five tion until the provisions of paragraph sample units representing each lot (c) are satisfied. have been found to be equal to or (ii) If either of the PFF Standardized greater than the required minimum Averages, Arithmetic or Weighted, for PFF percentage; and the last 100 consecutive lots falls below (ii) The PFF percentage of each sam- zero or either of the PFF Standardized ple unit (50 in all) is above the Abso- Averages for the last 36 consecutive lute Minimum PFF Percentage.

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(3) If a country is subject to reten- § 327.25 Disposition procedures for tion procedures under this section, the product condemned or ordered de- country shall be returned to normal stroyed under import inspection. monitoring procedures when: (a) Carcasses, parts thereof, meat and (i) Twenty-five consecutively pre- meat food products (other than ren- sented lots of cured pork product have dered animal fats) that have been been sampled as required in paragraph treated in accordance with the provi- (c)(1) of this section and the average of sions of this section shall be considered each set of five sample units rep- denatured for the purposes of the regu- resenting each lot have been found to lations in this part, except as other- be equal to or greater than the re- wise provided in part 314 of this sub- quired minimum PFF percentage; and chapter for articles condemned at offi- (ii) The PFF percentage of each sam- cial establishments or at official imple unit (125 in all) is above the Abso- port inspection establishments. lute Minimum PFF Percentage; and (1) The following agents are pre- (iii) Both of the PFF Standardized scribed for denaturing carcasses, parts Averages for 36 consecutive lots are in thereof, meat or meat food products the required percentage of the Normal which are affected with any condition distribution; and that would result in their condemna- (iv) Both of the PFF Standardized tion and disposal under part 314 of this Averages for 100 consecutive lots are subchapter if they were at an official zero or higher. establishment or at an official import (4) The sample units collected under inspection establishment: Crude car- retention procedures as provided in bolic acid; cresylic disinfectant; a for- paragraph (c)(2) of this section will not mula consisting of 1 part FD&C green No. 3 coloring, 40 parts water, 40 parts be included in the PFF standardized liquid detergent, and 40 parts oil of cit- averages for 36 and 100 consecutive ronella, or other proprietary substance lots. approved by the Administrator in spe- (d) Adulterated and Misbranded Prod- cific cases. 1 ucts. Products not meeting specified (2) Meat may be denatured by dipping PFF requirements, determined accord- it in a solution of 0.0625 percent tannic ing to procedures set forth in this sec- acid, followed by immersion in a water tion, may be deemed adulterated under bath, then dipping it in a solution of section 1(m)(8) of the Act (21 U.S.C. 0.0625 percent ferric acid; and except as 601(m)(8)) and misbranded under sec- provided in paragraphs (a) (3) and (5) of tion 1(n) of the Act (21 U.S.C. 601(n)). this section, the following agents are (e) Activities requiring additional prescribed for denaturing other car- inspectional supervision, such as re- casses, parts thereof, meat and meat labeling, shall be at the importer’s ex- food products, for which denaturing is pense. In addition, if the importer required by this part: FD&C green No. wishes, he or she may have samples 3 coloring; FD&C blue No. 1 coloring; analyzed at an accredited laboratory. FD&C blue No. 2 coloring; finely powdered charcoal; or other proprietary [50 FR 9792, Mar. 12, 1985, as amended at 54 substance approved by the Adminis- FR 41049, Oct. 5, 1989] trator in specific cases. 1 Carcasses § 327.24 Appeals; how made. (other than viscera), parts thereof, cuts of meat, and unground pieces of meat Any appeal from a decision of any darkened by charcoal or other black program employee shall be made to his/ dyes shall be deemed to be denatured her immediate supervisor having juris- pursuant to this section only if they diction over the subject matter of the appeal, except as otherwise provided in 1 Information as to approval of any propri- the applicable rules of practice. etary denaturing substance may be obtained [51 FR 37707, Oct. 24, 1986, as amended at 60 from the Meat and Poultry Inspection Tech- FR 67456, Dec. 29, 1995] nical Services, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250.

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contain at least that degree of dark- agent shall be used to give the material ness depicted by diagram 1 of the Meat a distinctive color, odor, or taste so Denaturing Guide (MP Form 91). 2 that such material cannot be confused (3) Tripe may be denatured by dip- with an article of human food. ping it in a 6 percent solution of tannic (b) Inedible rendered animal fats acid for 1 minute followed by immer- shall be denatured by thoroughly mix- sion in a water bath, then immersing it ing therein denaturing oil, No. 2 fuel for 1 minute in a solution of 0.022 per- oil, brucine dissolved in a mixture of cent FD&C yellow No. 5 coloring. alcohol and pine oil or oil of rosemary, (4) When meat, meat byproducts, or finely powdered charcoal, or any pro- meat food products are in ground form, prietary denaturing agent approved for 4 percent by weight of coarsely ground the purpose by the Administrator in hard done, which shall be in pieces no specific cases. The charcoal shall be smaller than the opening size specified used in no less quantity than 100 parts for No. 5 mesh in the standards issued per million and shall be of such char- by the U.S. Bureau of Standards or 6 acter that it will remain suspended in- percent by weight of coarsely ground definitely in the liquid fat. Sufficient hard bone, which shall be in pieces no of the chosen identifying agents shall smaller than the opening size specified be used to give the rendered fat so dis- for No. 8 mesh in said Standards, uni- tinctive a color, odor, or taste that it formly incorporated with the product, cannot be confused with an article of may be used in lieu of the agents pre- human food. scribed in paragraph (a)(2) of this section. [51 FR 37707, Oct. 24, 1986] (5) Before the denaturing agents are applied to articles in pieces more than § 327.26 Official import inspection 4 inches in diameter, the pieces shall marks and devices. be freely slashed or sectioned. (If the (a) When import inspections are per- articles are in pieces not more than 4 formed in official import inspection es- inches in diameter, slashing or sec- tablishments, the official inspection tioning will not be necessary.) The ap- legend to be applied to imported meat plication of any of the denaturing and meat food products shall be in the agents listed in paragraph (a) (1) or (2) appropriate form 1 as herein specified. of this section to the outer surface of molds or blocks or boneless meat, meat by-products, or meat food products shall not be adequate. The denaturing agent must be mixed intimately with all the material to be denatured, and must be applied in such quantity and manner that it cannot easily and readily be removed by washing or soaking. A sufficient amount of the appropriate

2 Copies of MP Form 91 may be obtained, without charge, by writing to the Adminis- trative Operations Branch, Food Safety and For application to cattle, sheep, Inspection Service, U.S. Department of Agri- swine, and goat carcasses, primal culture, 123 East Grant Street, Minneapolis, parts, and cuts, not in containers. Minnesota 55403. Diagrams 2 and 3 of the Meat Denaturing Guide are for comparison purposes only. The Meat Denaturing Guide 1 The number ‘‘I–38’’ is given as an example has been approved for incorporation by ref- only. The establishment number of the offi- erence by the Director, Office of the Federal cial import inspection establishment where Register, and is on file at the Federal Reg- the imported product is inspected shall be ister Library. used in lieu thereof.

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For application to outside containers of horsemeat food products. For application to outside containers of meat and meat food products prepared from cattle, sheep, swine, and goats.

For application to mule and other (nonhorse) equine carcasses, primal parts, and cuts, not in containers.

For application to horse carcasses, primal parts, and cuts, not in containers.

For application to outside containers of equine meat food products.

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(b) Except for product offered for AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, entry from Canada, when import in- 2.55. spections are performed in official es- SOURCE: 35 FR 15617, Oct. 3, 1970, unless tablishments the official inspection otherwise noted. legend to be applied to meat and meat food products offered for entry shall be § 329.1 Article or livestock subject to the appropriate form as specified in administrative detention. §§ 312.2 and 312.3 of this subchapter. Any carcass, part of a carcass, meat (c) When products are refused entry or meat food product of livestock, or into the United States, the official article exempted from the definition of mark to be applied to the products re- meat food product, or any dead, dying, fused entry shall be in the following disabled, or diseased livestock is sub- form: ject to detention for a period not to exceed 20 days when found by any authorized representative of the Secretary upon any premises where it is held for the purposes of, or during or after distribution in, commerce or it is otherwise subject to Title I or II of the Act, and there is reason to believe that: (a) Any such article is adulterated or (d) Devices for applying ‘‘United misbranded and is capable of use as States Refused Entry’’ marks shall be human food; or furnished to Program inspectors by the (b) Any such article has not been in- Department. spected, in violation of the provisions (e) The ordering and manufacture of of Title I of the Act, any other Federal brands containing official inspection law, or the laws of any State or Terri- legends shall be in accordance with the tory, or the District of Columbia; or provisions contained in § 317.3(c) of the (c) Any such article or livestock has Federal meat inspection regulations. been or is intended to be, distributed in [51 FR 37708, Oct. 24, 1986, as amended at 54 violation of the provisions of Title I of FR 41049, Oct. 5, 1989] the Act, any other Federal law, or the laws of any State or Territory, or the PART 329—DETENTION; SEIZURE District of Columbia. AND CONDEMNATION; CRIMI- § 329.2 Method of detention; form of NAL OFFENSES detention tag. An authorized representative of the Sec. 329.1 Article or livestock subject to admin- Secretary shall detain any article or istrative detention. livestock to be detained under this 329.2 Method of detention; form of detention part, by affixing an official ‘‘U.S. De- tag. tained’’ tag (FSIS Form 8400–2) to such 329.3 Notification of detention to the owner article or livestock. of the article or livestock detained, or the owner’s agent, and person having [55 FR 47842, Nov. 16, 1990] custody. 329.4 Notification of governmental authori- § 329.3 Notification of detention to the ties having jurisdiction over article or owner of the article or livestock de- livestock detained; form of written noti- tained, or the owner’s agent, and fication. person having custody. 329.5 Movement of article or livestock de- (a) When any article or livestock is tained; removal of official marks. detained under this part, an authorized 329.6 Articles or livestock subject to judi- representative of the Secretary shall: cial seizure and condemnation. (1) Orally notify the immediate cus- 329.7 Procedure for seizure, condemnation and disposition. todian of the article or livestock de- 329.8 Authority for condemnation or seizure tained, and under other provisions of law. (2) Promptly furnish a copy of a com- 329.9 Criminal offenses. pleted ‘‘Notice of Detention’’ (FSIS

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Form 8080–1) to the immediate custo- (b) Upon terminating the detention dian of the detained article or live- of such article or livestock, an author- stock. ized representative of the Secretary (b) If the owner of the detained arti- shall: cle or livestock, or the owner’s agent, (1) Orally notify the immediate cus- is not the immediate custodian at the todian of the released article or live- time of detention and if the owner, or stock, and owner’s agent, can be ascertained and (2) Furnish copies of a completed notified, an authorized representative ‘‘Notice of Termination of Detention’’ of the Secretary shall furnish a copy of (FSIS Form 8400–1) to the persons noti- the completed ‘‘Notice of Detention’’ fied when the article or livestock was to the owner or the owner’s agent. detained. The notice shall be served by Such copy shall be served, as soon as either delivering the notice to such possible, by delivering the notification persons or by certifying and mailing to the owner, or the owner’s agent, or the notice to such persons at their last by certifying and mailing the notifica- known residences or principal offices tion to the owner, or the owner’s agent, or places of business. at his or her last known residence or (c) All official marks may be required principal office or place of business. by such representative to be removed from such article or livestock before it [55 FR 47842, Nov. 16, 1990] is released unless it appears to the sat- § 329.4 Notification of governmental isfaction of the representative that the authorities having jurisdiction over article or livestock is eligible to retain article or livestock detained; form such marks. of written notification. [35 FR 15617, Oct. 3, 1970, as amended at 36 FR Within 48 hours after the detention of 12004, June 24, 1971; 39 FR 36000, Oct. 7, 1974; any livestock or article pursuant to 55 FR 47842, Nov. 16, 1990] this part, an authorized representative of the Secretary shall give oral or writ- § 329.6 Articles or livestock subject to ten notification of such detention to judicial seizure and condemnation. any Federal authorities not connected Any carcass, part of a carcass, meat with the Program, and any State or or meat food product, or any dead, other governmental authorities, having dying, disabled, or diseased livestock, jurisdiction over such livestock or arti- that is being transported in commerce cle. In the event notification is given or is otherwise subject to Title I or II orally, it shall be confirmed in writing, of the Act, or is held for sale in the as promptly as circumstances permit. United States after such transportation, is subject to seizure and con- § 329.5 Movement of article or live- demnation, in a judicial proceeding stock detained; removal of official pursuant to section 403 of the Act if marks. such article or livestock: (a) No article or livestock detained in (a) Is or has been prepared, sold, accordance with the provisions in this transported, or otherwise distributed part shall be moved by any person from or offered or received for distribution the place at which it is located when so in violation of the Act, or detained, until released by an author- (b) Is capable of use as human food ized representative of the Secretary: and is adulterated or misbranded, or Provided, That any such article or live- (c) In any other way is in violation of stock may be moved from the place at the Act. which it is located when so detained, for refrigeration, freezing, or storage § 329.7 Procedure for seizure, con- purposes if such movement has been demnation, and disposition. approved by an authorized representa- Any article or livestock subject to tive of the Secretary: And provided fur- seizure and condemnation under this ther, That the article or livestock so part shall be liable to be proceeded moved will be detained by an author- against and seized and condemned, and ized representative of the Secretary disposed of, at any time, on an appro- after such movement until such time priate pleading in any United States as the detention is terminated. district court, or other proper court

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specified in section 404 of the Act, the Commonwealth of Puerto Rico) or within the jurisdiction of which the ar- organized Territory. ticle or livestock is found. § 331.2 Designation of States under § 329.8 Authority for condemnation or paragraph 301(c) of the Act. seizure under other provisions of Each of the following States has been law. designated, under paragraph 301(c) of The provisions of this part relating the Act, as a State in which the provi- to seizure, condemnation and disposi- sions of Titles I and IV of the Act shall tion of articles or livestock do not der- apply to operations and transactions ogate from authority for condemnation wholly within such State. The Federal or seizure conferred by other provisions provisions apply, effective on the dates of the Act, or other laws. shown below:

§ 329.9 Criminal offenses. Effective date of applica- State tion of Federal provisions The Act contains criminal provisions with respect to numerous offenses spec- Alaska ...... July 31, 1999. Arkansas ...... June 1, 1981. ified in the Act, including but not lim- California ...... Apr. 1, 1976. ited to bribery of Program employees, Colorado ...... July 1, 1975. receipt of gifts by Program employees, Connecticut ...... Oct. 1, 1975. Florida ...... Dec. 2, 1997. and forcible assaults on, or other inter- Guam ...... Jan. 21, 1972. ference with, Program employees while Hawaii ...... Nov. 1, 1995. engaged in, or on account of, the per- Idaho ...... July 1, 1981. formance of their official duties under Kentucky ...... Jan. 14, 1972. Maryland ...... Mar. 31, 1991 the Act. Massachusetts ...... Jan. 12, 1976. Michigan ...... Oct. 3, 1981. Nebraska ...... Oct. 1, 1971. PART 331—SPECIAL PROVISIONS Nevada ...... July 1, 1973. FOR DESIGNATED STATES AND New Hampshire ...... Aug. 6, 1978. New Jersey ...... July 1, 1975. TERRITORIES; AND FOR DESIGNA- New Mexico ...... Aug. 13, 2007. TION OF ESTABLISHMENTS WHICH New York ...... July 16, 1975. Northern Mariana Islands ...... Oct. 29, 1979. ENDANGER PUBLIC HEALTH AND Oregon ...... July 1, 1972. FOR SUCH DESIGNATED ESTAB- Pennsylvania ...... July 17, 1972. Puerto Rico ...... June 18, 1971. LISHMENTS Rhode Island ...... Oct. 1, 1981. Tennessee ...... Oct. 1, 1975. Sec. Virgin Islands of the U.S ...... Nov. 27, 1971. 331.1 Definition of ‘‘State.’’ Washington ...... June 1, 1973. 331.2 Designation of States under paragraph 301(c) of the Act. [35 FR 19667, Dec. 29, 1970] 331.3 States designated under paragraph 301(c) of the Act; application of regula- EDITORIAL NOTE: For FEDERAL REGISTER ci- tions. tations affecting § 331.2, see the List of CFR 331.4 Control and disposal of non-federally- Sections Affected, which appears in the inspected products in States designated Finding Aids section of the printed volume under paragraph 301(c) of the Act. and at www.fdsys.gov. 331.5 Criteria and procedure for designating establishments with operations which § 331.3 States designated under para- would clearly endanger the public health; graph 301(c) of the Act; application disposition of products; application of of regulations. regulations. The provisions of the regulations in 331.6 Designation of States under section this subchapter apply to operations 205 of the Act; application of sections of and transactions wholly within each the Act and the regulations. State designated in § 331.2 under para- AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, graph 301(c) of the Act, except as other- 2.55. wise provided in this section. (The pro- SOURCE: 35 FR 19667, Dec. 29, 1970, unless visions of the regulations apply in all otherwise noted. respects to operations and transactions in or for commerce.) § 331.1 Definition of ‘‘State’’. (a) Each establishment located in For purposes of this part, the term such a designated State shall be grant- ‘‘State’’ means any State (including ed inspection required under

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§ 302.1(a)(2) of this subchapter only if it subchapter, will be granted by the cir- is found, upon a combined evaluation cuit supervisor for labeling and mark- of its premises, facilities, and oper- ing devices that he determines are nei- ating procedures, to be capable of pro- ther false nor misleading, provided the ducing products that are not adulter- official inspection legend bearing the ated or misbranded. official establishment number is ap- (b) Section 305.2 of this subchapter plied to the principal display panel of will apply to establishments required each label, either by a mechanical to have inspection under § 302.1(a)(2) of printing device or a self-destructive this subchapter, except that existing pressure sensitive sticker, and provided interconnections between official and the label shows the true product name, unofficial establishments will be per- an accurate ingredient statement, the mitted if it is determined in specific name and address of the manufacturer, cases that the interconnections are packer, or distributor, and any other such that transfer of inedible product features required by paragraph 1(n) of into the official establishment would the Act. be difficult or unusual, and any such (2) The circuit supervisor will for- transfers are strictly prohibited, except ward one copy of each item of labeling as permitted under other provisions of and a description of each marking de- this subchapter. It is essential that vice for which he has granted tem- separation of facilities be maintained porary approval to the Washington, to the extent necessary to assure that DC, office of the Labeling and Pack- inedible product does not enter the of- aging Staff and will retain one copy in ficial establishment contrary to the a temporary approval file for the estab- regulations in this subchapter. lishment. (c) Sections 416.2(c), (d), (e), (f), and (3) The operator of the official estab- (h) of this chapter shall apply to such lishment shall promptly forward a copy establishments. of each item of labeling and a descrip- (d) Section 314.2 of this subchapter tion of each marking device for which shall apply to such establishments, ex- temporary approval has been granted cept that a separate room or compart- by the circuit supervisor (showing any ment need not be provided for inedible modifications required by the circuit products if they can be handled so that supervisor) to the Labels and Pack- they do not create insanitary condi- aging Staff, Meat and Poultry Inspec- tions in any room or compartment tion, Food Safety and Inspection Serv- used for edible products or otherwise ice, USDA, Washington, DC 20250, ac- render any edible products adulterated companied by the formula and details and do not interfere with the conduct of preparation and packaging for each of inspection. For example, intestines, product. Within 90 days after inaugura- paunch contents, feet, and hides might tion of inspection, all labeling material be accumulated on the kill floor in and marking devices temporarily ap- clean, watertight drums with close fit- proved by the circuit supervisor must ting covers if there is sufficient space receive approval as required by §§ 316.7, to store them out of the way until the 317.3, and 317.4, of this subchapter or close of the day’s operation. their use must be discontinued. (e) Sections 316.7, 317.3, and 317.4 of (4) The circuit supervisor will also re- this subchapter shall apply to such es- view all shipping containers to insure tablishments, except as provided in that they do not have any false or mis- this paragraph (e). leading labeling and are otherwise not (1) The operator of each such estab- misbranded. Modifications of unaccept- lishment shall, prior to the inaugura- able information on labeling material tion of inspection, identify all labeling by the use of self-destructive pressure and marking devices in use, or pro- sensitive tape or by blocking out with posed for use (upon the date of inau- an ink stamp will be authorized on a guration of inspection) to the circuit temporary basis to permit the max- supervisor of the circuit in which the imum allowable use of all labeling ma- establishment is located. Temporary terials on hand. All unacceptable label- approval, pending formal approval ing material which is not modified to under §§ 316.7, 317.3, and 317.4 of this comply with the requirements of this

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subchapter must be destroyed or re- vided they are not adulterated or mis- moved from the official establishment. branded, except that the official in- (f) Sections 320.1, 320.2, 320.3, 320.4, spection legend is not required. Within 320.5, 325.20, and 325.21 apply to oper- the 90-day period, products that have ations and transactions not in or for been inspected by the State or local in- commerce in a State designated under spection agency may be further pre- paragraph 301(c) only if the State is pared and otherwise handled in official also designated under section 205 of the establishments required to have inspec- Act and if such provisions are application under § 302.1(a)(2) of this sub- ble as shown in § 331.6. chapter or at establishments exempted (g) Section 321.1(a) of this subchapter from the requirements of such inspec- will not apply to States designated tion under § 303.1 of this subchapter, under paragraph 301(c) of the Act. and may be distributed as provided in (h) Parts 322 and 327 and § 325.3 of this this section but otherwise shall be han- subchapter relating to exports and im- dled in accordance with § 305.4 of this ports do not apply to operations and subchapter. Such products shall not transactions solely in or for intrastate bear any [Federal] official inspection commerce. legends. After said 90–day period, only (i) Part 325 of this subchapter will federally inspected and passed products apply to establishments required to may be distributed within the des- have inspection under § 302.1(a)(2) of ignated State, except as provided in this subchapter and to operations and § 303.1 of this subchapter. transactions solely in or for intrastate § 331.5 Criteria and procedure for des- commerce, except as provided in para- ignating establishments with oper- graphs (h) and (j) of this section. ations which would clearly endan- (j) Sections 325.4, 325.15, and 325.1(b) ger the public health; disposition of of this subchapter will not apply to re- products; application of regula- quire a certificate, or evidence thereof, tions. for the distribution solely within any (a) An establishment preparing prod- designated State of products that are ucts solely for distribution within any U.S. inspected and passed and so State shall be designated as one pro- marked. ducing adulterated products which [35 FR 19667, Dec. 29, 1970, as amended at 36 would clearly endanger the public FR 12004, June 24, 1971; 41 FR 18089, Apr. 30, health, if: 1976; 62 FR 45026, Aug. 25, 1997; 64 FR 56416, (1) Any meat or meat food product Oct. 20, 1999] prepared at the establishment is adulterated in any of the following re- § 331.4 Control and disposal of non- spects: federally-inspected products in (i) It bears or contains a pesticide States designated under paragraph chemical, food additive, or color addi- 301(c) of the Act. tive, that is ‘‘unsafe’’ within the mean- Upon the effective date of designa- ing of sections 408, 409, or 706 of the tion of a State under paragraph 301(c) Federal Food, Drug, and Cosmetic Act of the Act, no products can be prepared or was intentionally subjected to radi- within the State unless they are pre- ation in a manner not permitted under pared under inspection pursuant to the section 409 of said Act; or if it bears or regulations in this subchapter or are contains any other added poisonous or exempted from the requirement of in- added deleterious substance which may spection under § 303.1 of this sub- render it injurious to health or make it chapter, and no unexempted products unfit for human food; or which were prepared without any in- (ii) It consists in whole or in part of spection can lawfully be distributed any filthy, putrid, or decomposed sub- within the State. For a period of 90 stance or is for any other reason un- days from the effective date of such sound, unhealthful, or unwholesome or designation, products which were pre- otherwise unfit for human food (for ex- pared and inspected and passed under ample, it was prepared from meat or the supervision of a responsible State other ingredients exhibiting spoilage or local inspection agency can be dis- characteristics; or it is, or was pre- tributed solely within the State, pro- pared from, a carcass affected with a

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disease transmissible to humans and written notification shall clearly speci- its condemnation would be required fy the deficiencies deemed to result in under part 309 or 310 of the Federal the production of adulterated products Meat Inspection regulations (9 CFR and shall specify a reasonable time for parts 309, 310) at federally inspected es- such action under State or local law. tablishments; or it is a ready-to-eat (2) If effective action is not taken pork product which has not been treat- under State or local law within the ed to destroy trichinae as prescribed in specified time, written notification § 318.10 of this subchapter for products shall be issued by the Regional Direc- at federally inspected establishments); tor to the operator of the establish- or ment, specifying the deficiencies in- (iii) It has been prepared, packed or volved and allowing him ten days to held under insanitary conditions whereby it may have become contami- present his views or make the nec- nated with filth or may have been ren- essary corrections, and notifying him dered injurious to health (for example that failure to correct such deficiencies if insects or vermin are not effectively may result in designation of the estab- controlled at the establishments, or in- lishment and operator thereof as sub- sanitary water is used in preparing ject to the provisions of titles I and IV meat or meat food products for human of the Act as though engaged in com- food); or merce. (iv) It is, in whole or in part, the (3) Thereafter the Program Inspector product of an animal that died other- shall survey the establishment and des- wise than by slaughter; or ignate it if he determines, in consulta- (v) Its container is composed, in tion with the Regional Director, that it whole or in part, of any poisonous or is producing adulterated products, deleterious substance which may which would clearly endanger the pub- render the contents injurious to lic health, and formal notice of such health; and designation will be issued to the oper- (2) Such adulterated articles are in- ator of the establishment by the Re- tended to be or are distributed from gional Director. the establishment while capable of use (c) Products on hand at the time of as human food. designation of an establishment under (b) When any such establishment is this section are subject to detention, identified by a Program Inspector as one producing adulterated product, seizure and condemnation in accord- which would clearly endanger public ance with part 329 of this subchapter: health under the criteria in paragraph Provided, That products that have been (a) of this section, the following proce- federally inspected and so identified dure will be followed: and that have not been further pre- (1) The Program Inspector will infor- pared at any nonfederally inspected es- mally advise the operator of the estab- tablishment may be released for dis- lishment concerning the deficiencies tribution if the products appear to be found by him and report his findings to not adulterated or misbranded at the the appropriate Regional Director for time of such release. the Program. When it is determined by (d) No establishment designated the Regional Director that any estab- under this section can lawfully prepare lishment preparing products solely for any products unless it first obtains in- distribution within any State is pro- spection or qualifies for exemption ducing adulterated products for dis- under § 303.1 of this subchapter. All of tribution within such State which the provisions of the regulations shall would clearly endanger the public apply to establishments designated health, written notification thereof under this section, except that the ex- will be issued to the appropriate State ceptions provided for in § 331.3 of this officials, including the Governor of the part shall apply to such establish- State and the appropriate Advisory ments. Committee, for effective action under State or local law to prevent such endangering of the public health. Such

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§ 331.6 Designation of States under a State in which the provisions of the section 205 of the Act; application sections of the Act and regulations of sections of the Act and the regu- specified below shall apply to operators lations. engaged, other than in or for com- Each of the following States has been merce, in the kinds of business indi- designated, effective on the date shown cated below: below, under section 205 of the Act, as

Sections of act and regu- Effective date of lations Classes of operators State designation

Act, section 202; Persons engaged (not in or for commerce) in (1) the busi- Alaska ...... July 31, 1999. §§ 320.1, 320.2, 320.3, ness of slaughtering any livestock or preparing, freezing, Arkansas ...... Mar. 29, 1982. and 320.4. packaging or labeling any livestock carcasses or parts or California ...... Apr. 1, 1976. products thereof, for use as human food or animal food; Colorado ...... July 1, 1975. (2) the business of buying or selling (as a meat broker, Connecticut ...... Oct. 1, 1975. wholesaler, or otherwise), transporting or storing any live- Guam ...... Nov. 19, 1976. stock carcasses or parts or products thereof; or (3) busi- Idaho ...... Mar. 29, 1982. ness as a renderer, or in the business of buying, selling, or Kentucky ...... Apr. 18, 1973. transporting any dead, dying, disabled, or diseased live- Maryland ...... Mar. 31, 1991. stock or parts of carcasses of any livestock that died other- Massachusetts .. Jan. 12, 1976. wise than by slaughter. Michigan ...... Mar. 29, 1982. Nebraska ...... Jan. 31, 1975. Nevada ...... Jan. 31, 1975. New Hampshire Oct. 29, 1979. New Jersey ...... July 1, 1975. New York ...... July 16, 1975. Northern Mar- Oct. 29, 1979. iana Islands. Oregon ...... Jan. 31, 1975. Pennsylvania ..... May 2, 1974. Puerto Rico ...... Nov. 19, 1976. Rhode Island ..... Mar. 29, 1982. Tennessee ...... Oct. 1, 1975. Virgin Islands .... Nov. 19, 1976. Washington ...... Jan. 31, 1975. Act, 203; § 320.5 ...... Persons engaged (not in or for commerce) in business as a Alaska ...... July 31, 1999. meat broker; renderer; animal food manufacturer; whole- Arkansas ...... Mar. 29, 1982. saler or public warehouseman of livestock carcasses, or California ...... Apr. 1, 1976. parts or products thereof; or buying, selling, or transporting Colorado ...... July 1, 1975. any dead, dying, disabled, or diseased livestock, or parts Connecticut ...... Oct. 1, 1973. of carcasses of any such livestock that dies otherwise than Guam ...... Nov. 19, 1976. by slaughter. Idaho ...... Mar. 29, 1982. Kentucky ...... Apr. 18, 1976. Maryland ...... Mar. 31, 1991. Massachusetts .. Jan. 12, 1975. Michigan ...... Mar. 29, 1982. Nebraska ...... Jan. 31, 1975. Nevada ...... Jan. 31, 1975. New Hampshire Oct. 29, 1979. New Jersey ...... July 1, 1975. New York ...... July 16, 1973. Northern Mar- Oct. 29, 1979. iana Islands. Oregon ...... Jan. 31, 1974. Pennsylvania ..... May 2, 1975. Puerto Rico ...... Nov. 19, 1976. Rhode Island ..... Mar. 29, 1982. Tennessee ...... Oct. 1, 1975. Virgin Islands .... Nov. 19, 1976. Washington ...... Jan. 31, 1975. Act, 204; §§ 325.20 and Persons engaged (not in or for commerce) in the business of Alaska ...... July 31, 1999. 325.21. buying, selling or transporting any dead, dying, disabled or Arkansas ...... Mar. 29, 1982. diseased animals, or parts of carcasses of any animals Connecticut ...... Oct. 1, 1975. that died otherwise than by slaughter. Guam ...... Nov. 19, 1976. Idaho ...... Mar. 29, 1982. Kentucky ...... Apr. 18, 1973. Maryland ...... Mar. 31, 1991. Massachusetts .. Jan. 12, 1976. Michigan ...... Mar. 29, 1982. Nevada ...... Jan. 31, 1975. New Hampshire Oct. 29, 1979. New Jersey ...... July 1, 1975. New York ...... July 16, 1975.

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Sections of act and regu- Effective date of lations Classes of operators State designation

Northern Mar- Oct. 29, 1979. iana Islands. Oregon ...... Jan. 31, 1975. Pennsylvania ..... May 2, 1974. Puerto Rico ...... Nov. 19, 1976. Rhode Island ..... Mar. 29, 1982. Virgin Islands .... Nov. 19, 1976. Washington ...... Jan. 31, 1975.

[35 FR 19667, Dec. 29, 1970]

EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 331.6, see the List of CFR Sec- tions Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

PART 332—SELECTED ESTABLISH- Designated personnel. State inspection MENTS; COOPERATIVE PRO- personnel that have been trained in the GRAM FOR INTERSTATE SHIPMENT enforcement of the Act and any additional State program requirements in OF CARCASSES, PARTS OF CAR- order to provide inspection services to CASSES, MEAT, AND MEAT FOOD selected establishments. PRODUCTS Interstate commerce. ‘‘Interstate commerce’’ has the same meaning as Sec. ‘‘commerce’’ under § 301.2 of this sub- 332.1 Definitions. chapter. 332.2 Purpose. Selected establishment. An establish- 332.3 Requirements for establishments; in- ment operating under a State coopera- eligible establishments. tive meat inspection program that has 332.4 State request for cooperative agreement. been selected by the Administrator, in 332.5 Establishment selection; official num- coordination with the State where the ber for selected establishments. establishment is located, to participate 332.6 Commencement of a cooperative inter- in a cooperative interstate shipment state shipment program; inspection by program. designated personnel and official mark. 332.7 Federal oversight of a cooperative § 332.2 Purpose. interstate shipment program. This part prescribes the conditions 332.8 Quarterly reports. under which States that administer co- 332.9 Enforcement authority. operative State meat inspection pro- 332.10 Deselection of ineligible establishments. grams and establishments that operate 332.11 Transition to official establishment. under such programs may participate 332.12 Transition grants. in a cooperative interstate shipment 332.13 Separation of operations. program. 332.14 Voluntary withdrawal. § 332.3 Requirements for establish- AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.18, ments; ineligible establishments. 2.53. (a) An establishment that operates SOURCE: 76 FR 24753, May 2, 2011, unless under a cooperative State meat inspec- otherwise noted. tion program may apply to participate in a cooperative interstate shipment § 332.1 Definitions. program under this part if: Cooperative interstate shipment pro- (1) The establishment employs on av- gram. A cooperative meat inspection erage no more than 25 employees based program described in § 321.3 of this sub- on the standards described in para- chapter. graph (b) of this section, or Cooperative State meat inspection pro- (2) The establishment employed more gram. A cooperative State-Federal than 25 employees but fewer than 35 meat inspection program described in employees as of June 18, 2008. If se- § 321.1 of this subchapter. lected to participate in a cooperative

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interstate shipment program, an estab- § 321.2 of this subchapter as of June 18, lishment under this paragraph must 2008; employ on average no more than 25 em- (3) Official establishments; ployees as of July 1, 2014, or it must (4) Establishments that were official transition to become an official estab- establishments as of June 18, 2008, but lishment as provided in § 332.11 of this that were re-organized on a later date part. by the person that controlled the es- (b) An establishment that has 25 or tablishment as of June 18, 2008; fewer employees based on the following (5) Establishments operating under a standards is considered to have 25 or cooperative State meat inspection that fewer employees on average for pur- employed more than 35 employees as of poses of this part. June 18, 2008, that were reorganized on (1) All individuals, both supervisory a later date by the person that con- and non-supervisory, employed by the trolled the establishment as of June 18, establishment on a full-time, part- 2008; time, or temporary basis whose duties (6) Establishments that are the sub- involve handling the meat or meat food ject of a transition under § 332.11 of this products prepared by the establishment part; are counted when calculating the total (7) Establishments that are in viola- number of employees. tion of the Act; (2) All individuals employed by the (8) Establishments located in States establishment from a temporary em- without a cooperative State meat in- ployee agency, professional employee spection program; and organization, or leasing concern whose (9) Establishments located in a State duties involve handling the meat or whose agreement for a cooperative meat food products prepared by the es- interstate shipment program was ter- tablishment are counted when calcu- minated by the Administrator as pro- lating the total number of employees. vided in § 321.3(d) of this subchapter. (3) The average number of employees (d) An establishment that meets the is calculated for each of the pay peri- conditions in paragraph (a) of this sec- ods for the preceding 12 calendar tion and that is not an ineligible estab- months. lishment under paragraph (c) of this (4) Part-time and temporary employ- section may apply for selection into a ees are counted the same as full-time cooperative interstate shipment pro- employees. gram through the State in which the (5) If the establishment has not been establishment is located. in business for 12 months, the average [76 FR 24753, May 2, 2011; 76 FR 81360, Dec. 28, number of employees is calculated for 2011] each of the pay periods in which the establishment has been in business. § 332.4 State request for cooperative (6) Volunteers who receive no com- agreement. pensation are not considered employees (a) State participation in a coopera- unless their duties involve handling tive interstate shipment program the meat or meat food products pre- under this part is limited to States pared by the establishment. that have implemented cooperative (7) The total number of employees State meat inspection programs. can never exceed 35 individuals at any (b) To request an agreement for a co- given time, regardless of the average operative interstate shipment program number of employees. under this part, a State must submit a (c) The following establishments are written request to the Administrator ineligible to participate in a coopera- through the FSIS District Office for tive interstate shipment program: the FSIS District in which the State is (1) Establishments that employ more located. In the request the State must: than 25 employees on average (except (1) Identify establishments in the as provided under paragraph (a)(2) of State that have requested to be se- this section); lected for the program that the State (2) Establishments operating under a recommends for initial selection into Federal-State program as provided in the program, if any;

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(2) Demonstrate that the State is a cooperative interstate shipment pro- able to provide the necessary inspec- gram if the establishment: tion services to selected establish- (1) Has submitted a request to the ments in the State and conduct any re- State to be selected for the program; lated activities that would be required (2) Has the appropriate number of under a cooperative interstate ship- employees under § 332.3(a) of this part; ment program established under this (3) Is not ineligible to participate in part; and a cooperative interstate shipment pro- (3) Agree that, if the State enters gram under § 332.3(c) of this part; into an agreement with FSIS for a co- (4) Is in compliance with all require- operative interstate shipment program, ments under the cooperative State the State will: meat inspection program; and (i) Provide FSIS with access to the (5) Is in compliance with all require- results of all laboratory analyses con- ments under the Act and the imple- ducted on product samples from se- menting regulations in this chapter. lected establishments in the State; (b) To participate in a cooperative (ii) Notify the selected establishment interstate shipment program, an estab- coordinator for the State of the results lishment that meets the conditions in of any laboratory analyses that indi- paragraph (a) of this section must be cate that a product prepared in a se- selected by the Administrator, in co- lected establishment may be adulter- ordination with the State where the es- ated or may otherwise present a food tablishment is located. safety concern; and (c) If an establishment is selected to (iii) When necessary, cooperate with participate in a cooperative interstate FSIS to transition selected establish- shipment program as provided in para- ments in the State that have been graph (b) of this section, the State is to deselected from a cooperative inter- assign the establishment an official state shipment program to become offi- number that reflects the establish- cial establishments. ment’s participation in the cooperative (c) If the Administrator determines interstate shipment program and ad- that a State that has submitted a revise the FSIS selected establishment quest to participate in a cooperative coordinator for the State of the official interstate shipment program qualifies number assigned to each selected es- to enter into a cooperative agreement tablishment in the State. The official for such a program, the Administrator number assigned to every selected es- and the State will sign a cooperative tablishment must contain a suffix, e.g., agreement that sets forth the terms ‘‘SE,’’ that identifies the establishment and conditions under which each party as a selected establishment and that will cooperate to provide inspection identifies the State, e.g., ‘‘SETX,’’ for services to selected establishments lo- ‘‘selected establishment Texas.’’ cated in the State. (d) Failure of the State to comply (d) After the Administrator and a with paragraph (c) of this section will State have signed an agreement for a disqualify the State from participation cooperative interstate shipment pro- in the cooperative interstate shipment gram as provided in paragraph (c) of program. this section, the Administrator will: (1) Appoint an FSIS employee as the § 332.6 Commencement of a coopera- FSIS selected establishment coordi- tive interstate shipment program; nator for the State and inspection by designated personnel (2) Coordinate with the State to se- and official mark. lect establishments to participate in (a) A cooperative interstate shipment the program as provided in § 332.5(b) of program will commence when the Ad- this part. ministrator, in coordination with the State, has selected establishments in § 332.5 Establishment selection; official the State to participate in the pro- number for selected establishments. gram. (a) An establishment operating under (b) Inspection services for selected a cooperative State meat inspection establishments participating in a coop- program will qualify for selection into erative interstate shipment program

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must be provided by designated per- (1) Verifying that each selected es- sonnel, who will be under the direct su- tablishment employs, and continues to pervision of a State employee. employ, 25 or fewer employees, on aver- (c) Carcasses, parts of carcasses, age, as required under § 332.3(a) of this meat, and meat food products prepared part, unless the establishment is in a selected establishment and in- transitioning to become an official es- spected and passed by designated State tablishment; personnel must bear an official Federal (2) Verifying that the designated per- mark, stamp, tag, or label of inspection sonnel are providing inspection serv- in the appropriate form prescribed in ices to selected establishments in a part 312 of this subchapter that in- manner that complies with the Act and cludes the information specified in the implementing regulations in this § 332.5(c) of this part. chapter; (d) Carcasses, parts of carcasses, (3) Verifying that that the State meat, and meat food products prepared staffing levels for each selected estab- in a selected establishment that com- lishments are appropriate to carry out ply with the conditions in paragraph the required inspection activities; and (c) of this section may be distributed in (4) Assessing each selected establish- interstate commerce. ment’s compliance with the Act and implementing regulations under this § 332.7 Federal oversight of a cooperative interstate shipment program. chapter. (c) If the selected establishment co- (a) The FSIS selected establishment ordinator determines that designated coordinator for a State that has en- personnel are providing inspection tered into an agreement for a coopera- services to selected establishments in tive interstate shipment program will the State in a manner that is incon- visit each selected establishment in sistent with the Act and the imple- the State on a regular basis to verify menting regulations in this chapter, that the establishment is operating in the Administrator will provide an op- a manner that is consistent with the portunity for the State to develop and Act and the implementing regulations implement a corrective action plan to in this chapter. The frequency with address inspection deficiencies identi- which the SEC will visit selected estab- fied by the selected establishment co- lishments under the SEC’s jurisdiction ordinator. If the State fails to develop will be based on factors that include, a corrective action plan, or the se- but are not limited to, the complexity lected establishment coordinator for of the operations conducted at the se- the State determines that the correc- lected establishment, the establish- tive action plan is inadequate, the Ad- ment’s schedule of operations, and the ministrator will terminate the agree- establishment’s performance under the ment for the cooperative interstate cooperative interstate shipment pro- shipment program as provided in gram. If necessary, the selected estab- § 321.3(d) of this chapter. lishment coordinator, in consultation with the District Manager that covers §332.8 Quarterly reports. the State, may designate qualified FSIS personnel to visit a selected es- (a) The selected establishment coor- tablishment on behalf of the selected dinator will prepare a report on a quar- establishment coordinator. terly basis that describes the status of (b) The selected establishment coor- each selected establishment under his dinator, in coordination with the or her jurisdiction. State, will verify that selected estab- (b) The quarterly report required in lishments in the State are receiving paragraph (a) of this section will: the necessary inspection services from (1) Include the selected establish- designated personnel, and that these ment coordinator’s assessment of the establishments are eligible, and remain performance of the designated per- eligible, to participate in a cooperative sonnel in conducting inspection activi- interstate shipment program. The se- ties at selected establishments and lected establishment coordinator’s (2) Identify those selected establish- verification activities may include: ments that the selected establishment

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coordinator has verified are in compli- (1) The non-compliance that led to ance with the Act and implementing the suspension; regulations in this chapter, those that (2) The selected establishment’s com- have been deselected under § 332.10 of pliance history; and this part, and those that are (3) The corrective actions proposed transitioning to become official estab- by the selected establishment. lishments under § 332.11 of this part. (c) The selected establishment coor- § 332.10 Deselection of ineligible estab- dinator is to submit the quarterly re- lishments. port to the Administrator through the (a) The Administrator will deselect a District Manager for the State where selected establishment that becomes the selected establishments identified ineligible to participate in a coopera- in the report are located. tive interstate shipment program for any reason listed under § 332.3(c) of this § 332.9 Enforcement authority. part. (a) To facilitate oversight and en- (b) An establishment that has been forcement of this part, selected estab- deselected must transition to become lishments operating under a coopera- an official establishment as provided in tive interstate shipment program § 332.11 of this part. must, upon request, give the FSIS selected establishment coordinator or § 332.11 Transition to official establish- other FSIS officials access to all estab- ment. lishment records required under the (a) If an establishment is deselected Act and the implementing regulations from a cooperative interstate shipment in this chapter. The Administrator program as provided in § 332.10 of this may deselect any selected establish- part, FSIS, in coordination with the ment that refuses to comply with this State where the establishment is lo- paragraph. cated, will develop and implement a (b) Selected establishment coordina- plan to transition the establishment to tors may initiate any appropriate en- become an official establishment. Ex- forcement action provided for in part cept that an establishment that was 500 of this chapter if they determine deselected from a cooperative inter- that a selected establishment under state shipment program because it is their jurisdiction is operating in a located in a State whose agreement for manner that is inconsistent with the such a program was terminated may ei- Act and the implementing regulations ther transition to become an official in this chapter. Selected establish- establishment or transition to become ments participating in a cooperative a State-inspected establishment under interstate shipment program are sub- the cooperative State meat inspection ject to the notification and appeal pro- program. cedures set out in part 500 of this chap- (b) An establishment that has been ter. deselected from a cooperative inter- (c) If inspection at a selected estab- state shipment program and success- lishment is suspended for any of the fully transitioned to become an official reasons specified in § 500.3 or § 500.4 of establishment may withdraw from the this chapter, FSIS will: Federal inspection program and resume (1) Provide an opportunity for the es- operations under the cooperative State tablishment to implement corrective meat inspection program after oper- actions and remain in the cooperative ating as an official establishment in interstate shipment program, or full compliance with the Act for a year. (2) Move to deselect the establishment as provided in § 332.10 of this part. § 332.12 Transition grants. (d) The decision to deselect a selected (a) Transition grants are funds that a establishment under a suspension will State participating in a cooperative be made on a case-by-case basis. In interstate shipment program under making this decision, FSIS, in con- this part may apply for to reimburse sultation with the State where the se- selected establishments in the State lected establishment is located, will for the cost to train one individual in consider, among other factors: the seven HACCP principles for meat

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or poultry processing as required under spection Act is reported to the Depart- § 417.7 of this chapter and associated ment of Justice by the Secretary for training in the development of sanita- criminal prosecution the Secretary tion standard operating procedures re- must give reasonable notice to the sus- quired under part 416 of this chapter. pected violator that the Secretary in- (b) A State participating in a cooper- tends to report the violation for pros- ative interstate shipment program that ecution and give the suspected violator receives a transition grant must use an opportunity to present the viola- grant funds to reimburse the training tor’s views to the Secretary with re- costs of one employee per each selected spect to such proceeding. establishment in the State. Any other use of such funds is prohibited. (1) Notice and opportunity need not be provided if the Secretary has any § 332.13 Separation of operations. reason to believe that providing such A selected establishment may con- notice and opportunity could result in duct operations under the cooperative the alteration or destruction of evi- State meat inspection program if the dence, or where disclosure could result establishment implements and main- in injury to persons or property. tains written procedures for complete (2) Notice and opportunity need not physical separation of product and be provided if the Secretary has any process for each operation by time or reason to believe that providing such space. notice and opportunity could result in flight of a suspected violator to avoid § 332.14 Voluntary withdrawal. prosecution. A selected establishment that is in (3) Notice and opportunity need not full compliance with the requirements be provided if the Secretary has any in this part may voluntarily end its reason to believe that providing such participation in a cooperative inter- notice and opportunity could result in state shipment program and operate compromising special investigative under the cooperative State meat in- techniques, such as undercover or spection program. Establishments that voluntarily end their participation in other covert operations. the cooperative may re-apply for the (4) Notice and opportunity need not program after operating under the co- be provided when the impending crimi- operative State meat inspection pro- nal referral involves suspicion of brib- gram for one year. ery and related offenses, or clandestine slaughtering and/or processing oper- PART 335—RULES OF PRACTICE ations. GOVERNING PROCEEDINGS (5) Notice and opportunity need not UNDER THE FEDERAL MEAT IN- be provided when the impending refer- SPECTION ACT ral is part of an investigation involving non-Act violations, and the Act and non-Act violations are jointly referred AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, for prosecution. 2.55. (b) A notice of opportunity to present views will be sent by registered or cer- Subpart A—Criminal Violations tified mail, summarize the violations that constitute the basis of the con- AUTHORITY: Sec. 406, Pub. L. 99–641, 100 templated prosecution, and describe Stat. 3571; 21 U.S.C. 606 note. the procedures for presentation of SOURCE: 42 FR 10960, Feb. 25, 1977. Redesig- views. Any information given by a re- nated at 64 FR 66545, Nov. 29, 1999. spondent, orally or in writing, shall become part of the Department’s official § 335.40 Opportunity for presentation record concerning the matter. The De- of views before report of criminal violations. partment is under no obligation to disclose evidence to the suspected viola- (a) Except as provided in paragraphs tor. (a)(1) through (5) of this section, before any violation of the Federal Meat In- [52 FR 13828, Apr. 27, 1987]

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PART 350—SPECIAL SERVICES RE- (h) Official establishment. An estab- LATING TO MEAT AND OTHER lishment operated under Federal meat PRODUCTS inspection pursuant to the Meat In- spection Act, as amended (21 U.S.C. 71 et seq.). Sec. (i) Food article. Any article of human 350.1 Meaning of words. food derived wholly or in part from 350.2 Definitions. meat, meat byproducts, or meat food 350.3 Types and availability of service. 350.4 [Reserved] products, which is not subject to the 350.5 Application for service. Federal meat inspection laws, and ani- 350.6 Denial or withdrawal of service. mal casings, for which the mark of 350.7 Fees and charges. Federal meat inspection is requested: 350.8 Scope and applicability of rules of Provided, That such articles and cas- practice. ings are derived from federally inspected and passed carcasses. AUTHORITY: 7 U.S.C. 1622, 1624; 7 CFR 2.17, (j) [Reserved] 2.55. (k) Secretary. The Secretary of Agri- SOURCE: 23 FR 9982, Dec. 23, 1958, unless culture of the United States, or any of- otherwise noted. Redesignated at 30 FR 4195, ficer or employee of the Department to Mar. 31, 1965, and further redesignated at 35 whom authority has heretofore been FR 15554, Oct. 3, 1970. delegated, or may hereafter be dele- § 350.1 Meaning of words. gated, to act in his stead in connection with the function involved. Words used in this part in the singular form shall be deemed to import [23 FR 9982, Dec. 23, 1958, as amended at 25 the plural, and vice versa, as the case FR 9642, Oct. 7, 1960; 30 FR 258, Jan. 9, 1965. Redesignated and amended at 30 FR 4195, may demand. Mar. 31, 1965; 32 FR 6021, Apr. 15, 1967; 32 FR 13115, Sept. 15, 1967. Further redesignated at § 350.2 Definitions. 35 FR 15554, Oct. 3, 1970, and amended at 43 For the purposes of the regulations FR 11147, Mar. 17, 1978; 54 FR 1329, Jan. 13, in this part, unless the context other- 1989] wise requires, the following terms shall § 350.3 Types and availability of serv- be construed, respectively, to mean: ice. (a) Department. The United States De- Upon application in accordance with partment of Agriculture. § 350.5 the following types of service (b) Service. The Food Safety and In- may be furnished under the regulations spection Service of the Department. in this part: (c) Administrator. The Administrator (a) Identification service. (1) Meat or of the Service or any officer or em- other product that is federally in- ployee of the Department to whom au- spected and passed at an official estab- thority has heretofore been delegated, lishment, or upon importation, under or to whom authority may hereafter be the meat inspection laws, is officially delegated, to act in his stead. marked to identify it as federally in- (d) [Reserved] spected and passed. In order to facili- (e) Inspector. Any officer or employee tate the division of such meat or other of the Department authorized to per- product into smaller portions or its form any duties under the regulations combination into larger units and still in this part. maintain its identity as product which (f) Person. Any individual, corpora- has been federally inspected and passed tion, company, association, firm, part- and so marked, inspectors may super- nership, society, or joint stock com- vise the handling of the product and pany, or other organized group of any mark such portions or units with the of the foregoing. marks of Federal inspection when they (g) Federally inspected and passed. In- determine that the identity has been spected and passed under the Meat In- maintained. spection Act, as amended (21 U.S.C. 71 (2) At the time service is furnished et seq.) or under the provisions in para- product must be sound, wholesome and graphs 306 (b) and (c) of the Tariff Act fit for human food. The service will be of 1930 (19 U.S.C. 1306 (b) and (c)). available only on premises other than

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those of an official establishment. The which will be furnished by the Admin- sanitation of the plant or area where istrator upon request. service is furnished must comply with (Approved by the Office of Management and applicable provisions of part 416, §§ 416.1 Budget under control number 0583–0036) through 416.6 of this chapter. [23 FR 9982, Dec. 23, 1958. Redesignated at 30 (3) The mark of inspection shall be FR 4195, Mar. 31, 1965, and at 35 FR 15554, Oct. applied only under the immediate su- 3, 1970, and amended at 47 FR 746, Jan. 7, pervision of an inspector. 1982] (4) The service will be available for § 350.6 Denial or withdrawal of serv- products moved in tank cars and tank ice. trucks from an official establishment or from a location operating under this (a) If any person has applied for service for meat or other product not eligi- service only if such tank cars or tank ble therefor under the regulations in trucks bear a label before leaving such this part, or has failed to make proper official establishment or such other lo- application for service or to pay fees cation, in accordance with 9 CFR and charges due for service furnished §§ 316.14 and 317.2. or to be furnished to him under the (b) Certification service. At the request regulations in this part, or if the serv- of a purchaser, supplier, exporter, or ice cannot be furnished to any person others, inspectors may make certifi- applying therefor because of lack of cation regarding livestock products for available inspectors or other adminis- human food purposes (including cas- trative reasons, the service may be de- ings), to be exported, as meeting condi- nied to such person by the Adminis- tions or standards that are not imposed trator until the condition justifying or are in addition to those imposed by such denial is corrected. the regulations in parts 301 through 331 (b) Service under the regulations in of this chapter and the laws under this part may also be denied to any which such regulations were issued. person by the Secretary for such period (c) Food inspection service. An inspec- as he may deem proper, if it is determined, after opportunity for hearing tion and certification service for before a proper official in the Depart- wholesomeness relating to the manu- ment, that such person has been re- facture of a food article may be fur- sponsible for any willful misrepresen- nished upon application. All applicable tation to the Department concerning provisions of this chapter shall apply any meat or other product for which to the preparation, labeling and certifi- service has been requested under the cation of the food article prepared regulations, in this part, or that such under this food inspection service. person has been responsible for the use (d) [Reserved] without authority, or the imitation, of [25 FR 9642, Oct. 7, 1960, as amended at 30 FR any marks or certificates of Federal 258, Jan. 9, 1965. Redesignated at 30 FR 4195, meat inspection on or with respect to Mar. 31, 1965, and amended at 30 FR 8675, any meat or other product, or has oth- July 9, 1965. Further redesignated at 35 FR erwise been responsible for any fraudu- 15554, Oct. 3, 1970, and amended at 38 FR lent or deceptive practice with respect 29215, Oct. 23, 1973; 53 FR 28634, July 29, 1988; to such service, or that such person has 54 FR 1329, Jan. 13, 1989; 64 FR 56416, Oct. 20, interfered with or obstructed any in- 1999; 65 FR 2284, Jan. 14, 2000] spector in the performance of his duties under the regulations in this part, § 350.4 [Reserved] or attempted to do so. When the Ad- ministrator determines that the public § 350.5 Application for service. interest so requires, he may deny or Any person who desires to receive withdraw service provided for in this service under the regulations in this part, without a hearing, pending final part for meat or other product eligible determination of the matter. The ap- therefor under such regulations may plicant or recipient of service involved make application for service to the Ad- shall be notified of the Administrator’s ministrator, upon an application form decision to deny or suspend service and the reasons therefor, in writing, in the

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manner prescribed in § 1.147(b) of the tor or inspectors in connection there- rules of practice (7 CFR 1.147(b)), or with during the regularly scheduled ad- orally. The Administrator’s decision to ministrative workweek. deny or suspend the service shall be ef- (d) Charges may also be made to fective upon such oral or written noti- cover the cost of travel and other ex- fication, whichever is earlier, to the penses incurred by the Service in con- applicant or recipient of service. If nection with the furnishing of the serv- such notification is oral, the Adminis- ice. trator shall confirm such decision and [23 FR 9982, Dec. 23, 1958, as amended at 53 the reasons therefor, in writing, as FR 13397, Apr. 22, 1988; 54 FR 6389, Feb. 10, promptly as circumstances permit, and 1989] such written confirmation shall be served upon the applicant or recipient § 350.8 Scope and applicability of rules of service, in the manner prescribed in of practice. § 1.147(b) of the rules of practice (7 CFR The rules of practice of the Depart- 1.147(b)). In other cases prior to the in- ment of Agriculture in subpart H of stitution of proceedings for denial of part I, subtitle A, title 7 of the Code of service under this paragraph, the facts Federal Regulations, are the rules of or conduct which may warrant such ac- practice applicable to adjudicatory, ad- tion shall be called to the attention of ministrative proceedings under the reg- the person involved, in writing, and he ulations in this part (9 CFR part 350). shall be given an opportunity to dem- [43 FR 11147, Mar. 17, 1978] onstrate or achieve compliance with all applicable requirements. PART 351—CERTIFICATION OF [23 FR 9982, Dec. 23, 1958; 25 FR 9642, Oct. 7, TECHNICAL ANIMAL FATS FOR 1960. Redesignated at 30 FR 4195, Mar. 31, 1965, and 35 FR 15554, Oct. 3, 1970, and amend- EXPORT ed at 43 FR 11147, Mar. 17, 1978] DEFINITIONS § 350.7 Fees and charges. Sec. (a) Fees and charges for service under 351.1 Meaning of words. the regulations in this part shall be 351.2 Terms defined. paid by the applicant for the service in SCOPE OF CERTIFICATION SERVICE accordance with this section, and, if required by the Administrator, the fees 351.3 Kind of service. and charges shall be paid in advance. PROCEDURE FOR OBTAINING SERVICE: (b) The fees and charges provided for ADMINISTRATION OF PROGRAM in this section shall be paid by check, 351.4 Application for certification service. draft, or money order payable to the 351.5 Conditions of eligibility for certifi- Treasurer of the United States and cation service; review of applications. shall be remitted promptly to the Ad- 351.6 Official number. ministrator upon furnishing to the ap- 351.7 Administration of certification service plicant of a statement as to the program. amount due. FEES (c) The fees to be charged and collected for service under the regulations 351.8 Charges for surveys of plants. 351.9 Charges for examinations. in this part shall be at the rates specified in §§ 391.2, 391.3, and 391.4 respec- FACILITIES AND OPERATIONS tively for base time; for overtime in- 351.10 Facilities. cluding Saturdays, Sundays, and holi- 351.11 Identification and separation of tech- days; and for certain laboratory serv- nical animal fats for certification and ices which are not covered under the materials for use therein; removal of base time, overtime, and/or holiday wrappers, etc.; cleaning of equipment. costs. Such fees shall cover the costs of 351.12 Circuit supervisor to be informed the service and shall be charged for the when plant operates. 351.13 Inspectors to have access to certified time required to render such services. plants at all times. Where appropriate, this time will in- 351.14 Processes to be supervised; extent of clude, but will not be limited to, the examinations. time required for travel of the inspec- 351.15 Reports of violations.

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TRANSPORTATION AND EXPORTATION OF (f) Circuit means one or more in- CERTIFIED TECHNICAL ANIMAL FAT spected plants assigned to a circuit su- 351.16 Certificate required for shipments of pervisor. technical animal fat. (g) Recognized State means any State 351.17 Identification required. not designated in § 331.2 of this chapter. (h) Cooperating State means any State PROHIBITIONS cooperating under § 351.7 in administra- 351.18 Official identifications; unauthorized tion of the regulations in this part. use. (i) Inspection means ante-mortem and post-mortem inspection by Program in- REMEDIES; PENALTIES spectors or inspectors of a Meat Inspec- 351.19 Refusal of certification for specific tion Service of a recognized State. lots. (j) Animals means cattle, sheep, 351.20 Withdrawal of service from certified swine, goats, horses, mules and other plants. equines. APPEALS (k) Technical animal fat means animal 351.21 Appeals. fat eligible for exportation, or storage for exportation, in accordance with RECORDS AND REPORTS § 325.11 of this chapter. 351.22 Certified plants to maintain records (l) Certified technical animal fat means and make reports; access to records. technical animal fat certified for export or storage for export under the AUTHORITY: 7 U.S.C. 1622, 1624; 7 CFR 2.17 regulations in this part. (g) and (i), 2.55. (m) Tallow means technical animal SOURCE: 40 FR 58627, Dec. 18, 1975, unless fat with a minimum titre of 40 °C. otherwise noted. (n) Certified plant means any plant or storage facility preparing or storing DEFINITIONS certified technical animal fat for ex- § 351.1 Meaning of words. port, or for transfer to another certified plant or storage facility for ulti- Words used in this part in the sin- mate export, and at which certification gular form shall be deemed to import service is provided under the regula- the plural, and vice versa, as the case tions in this part. may demand. (o) Inspected and Passed means inspected and passed under the Federal § 351.2 Terms defined. Meat Inspection Act (21 U.S.C. 601 et When used in this part, unless the seq.) or the meat inspection laws of a context otherwise requires: recognized State. (a) Department means the United States Department of Agriculture. SCOPE OF CERTIFICATION SERVICE (b) Program means the Meat and Poultry Inspection Program of the § 351.3 Kind of service. Food Safety and Inspection Service of (a) Certification, in the form set the Department. forth in paragraph (b), is available (c) Administrator means the Adminis- under the regulations in this part for trator of the Food Safety and Inspec- specific lots of technical animal fat for tion Service of the Department, or any export, if the fat was rendered from officer or employee of the Department materials derived from carcasses, or to whom authority has heretofore been parts of carcasses, that had been in- delegated or may hereafter be dele- spected and passed and came from ani- gated to act in his stead. mals that did not die otherwise than by (d) Circuit supervisor means an em- slaughter under inspection. The certifi- ployee of the Program assigned to su- cation will be made by a Program em- pervise and perform official work in a ployee when he determines, upon the circuit. Such employee is assigned by basis of examinations made by him or and reports directly to the Adminis- other inspectors, as provided in § 351.14, trator or person designated by him. and information obtained by him or (e) Inspector means an employee of them from the exporter or other the Program or a cooperating State. sources, as provided in the regulations

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in this part, that the technical animal untary fee basis in accordance with fat is eligible for certification under said regulations. this section and therefore the state- (b)(1) The form of Certificate for Ex- ments to be certified are correct. The port of Technical Animal Fats is as fol- service will be available upon a vol- lows:

(2) Certified technical animal fat made on forms 1 available from the Ad- may be described on the certificate as ministrator and provide all informa- ‘‘technical animal fat’’; or if it is tal- tion called for thereon relating to the low, it may be described on the certifi- identity of the applicant and the plant, cate as ‘‘Tallow’’ and the description and the nature of the plant operations, may include the statement ‘‘titre not and a certification of specified facts less than 40 °C.’’ and an agreement to comply with specified requirements. PROCEDURE FOR OBTAINING SERVICE: ADMINISTRATION OF PROGRAM (Approved by the Office of Management and Budget under control number 0583–0036) § 351.4 Application for certification [40 FR 58627, Dec. 18, 1975, as amended at 47 service. FR 746, Jan. 7, 1982] Application for certification service under the regulations in this part may § 351.5 Conditions of eligibility for certification service; review of applica- be made to the Administrator by the tions. operator of any rendering plant or storage facility at which technical animal (a) To be eligible for certification fat is prepared or stored for export. In service under the regulations in this case of a change of ownership or part, the operator of a rendering plant change of location, a new application must demonstrate that: shall be made. Applications shall be 1 Copy filed as part of the original document.

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(1) He operates a rendering plant present his views prior to refusal of the which will receive materials derived service. from inspected and passed carcasses, or (Approved by the Office of Management and parts of carcasses, of animals that did Budget under control number 0583–0036) not die otherwise than by slaughter under inspection, (i.e., not ‘‘dead ani- [40 FR 58627, Dec. 18, 1975, as amended at 41 mals’’); and such source materials will FR 12637, Mar. 26, 1976; 47 FR 746, Jan. 7, 1982] be rendered at the plant into technical § 351.6 Official number. animal fat eligible for export, or storage for export, in accordance with the The Administrator will assign a cer- regulations in this part; tified technical animal fat plant num- (2) The source materials and the ren- ber to each plant granted service. Such dered technical animal fat described in number shall be preceded by the letter paragraph (a)(1) will be identified and ‘‘C’’ and be used to identify all certified kept separated at all times from other technical animal fat prepared or stored products; and by the plant. (3) He will comply with the applica- § 351.7 Administration of certification ble regulations in this part. service program. (b) To be eligible for certification service under the regulations in this (a) The regulations in this part shall part, the operator of a storage facility be administered by the circuit super- must demonstrate that: visor for the jurisdiction in which is lo- (1) He operates a storage facility that cated the certified plant or plants for will receive for storage certified tech- which application for certification nical animal fat shipped directly from service is made, and such assistants as a certified rendering plant for storage may be necessary will be assigned by for export and he will keep such ship- the Administrator. ments identified and separated from (b) The Administrator may enter into other products that are not certified, a cooperative agreement with any rec- and he will receive such fat only if it is ognized State for the conduct by State accompanied by MP Form 85, as re- employees of any surveys, examina- quired by § 351.17. tions, and other activities involved in (2) He will comply with the applica- the administration of the regulations ble regulations in this part. in this part. However, certifications (c) Each applicant for certification under these regulations may be issued service must file with the Adminis- only by Program employees, as pro- trator, with the application for service, vided in § 351.3. a written description of the procedures FEES to be used for receiving, identifying, processing, storing, and otherwise han- § 351.8 Charges for surveys of plants. dling technical animal fat, and mate- Applicants for the certification serv- rials for use in the preparation thereof, ice shall pay the Department for salary at the plant or storage facility in- costs at the rates specified in §§ 391.2 volved, and for shipping technical ani- and 391.3 respectively for base time, mal fat from the plant or facility and and for overtime, travel, and per diem storing and exporting such technical allowances at rates currently allowed animal fat, and a written description of by the Federal Travel Regulations, and the shipping, receiving, and inventory other expenses incidental to the initial records maintained for technical ani- survey of the rendering plants or stor- mal fat. age facilities for which certification (d) The Administrator will deter- service is requested. mine, on the basis of all information available to him, whether the arrange- [54 FR 6389, Feb. 10, 1989] ments at the plant or storage facility are such as will assure that certifi- § 351.9 Charges for examinations. cations of technical animal fat will be (a) The fees to be charged and col- correct, and, if so, will grant the appli- lected by the Administrator for exam- cation for certification service. An ap- ination shall be at the rates specified plicant will be given an opportunity to in §§ 391.2, 391.3, and 391.4 respectively

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for base time; for overtime including plant and throughout processing or Saturdays, Sundays, and holidays, as handling at such plant. All wrappers provided for in § 351.14; and for certain and packaging shall be removed from laboratory services which are not cov- the source materials to the fullest ex- ered under the base time, overtime, tent practicable before the materials and/or holiday costs and which are re- are rendered at the plant. quired to determine the eligibility of (b) If a plant’s operations are within any technical animal fat for certifi- the provisions of § 351.14(b)(3), all equip- cation under the regulations in this ment shall be cleaned before it is used Part. Such fees shall be charged for the for receiving, preparation, or storage of time required to render such service, certified technical animal fats or mate- including, but not limited to, the time rial to be used in preparation of such required for the travel of the inspector fats. Such cleaning shall be done in or inspectors in connection therewith. such manner as to prevent contamina- (b) Charges may also be made to tion of such certified fats or source ma- cover the actual cost of travel and per terial with materials that are unac- diem allowance at rates currently al- ceptable under § 351.3. lowed by the General Services Admin- istration, and other expenses incurred § 351.12 Circuit supervisor to be in- by the Department in connection with formed when plant operates. such examinations and laboratory serv- The operator of each certified plant ice. shall inform the circuit supervisor, in [40 FR 58627, Dec. 18, 1975, as amended at 53 advance, when the plant’s work sched- FR 13397, Apr. 22, 1988; 54 FR 6389, Feb. 10, ule will include preparing technical 1989] animal fats for certification and identify the approximate days and hours FACILITIES AND OPERATIONS when operations will begin and end. § 351.10 Facilities. § 351.13 Inspectors to have access to (a) Facilities for the preparation, certified plants at all times. identification, and storage of the tech- For the purpose of administering the nical animal fat to be certified shall be regulations in this part, inspectors furnished and maintained by the cer- shall have access at all times by day or tified plant in accordance with this night to every part of a certified plant. section. (b) The operator of the certified plant § 351.14 Processes to be supervised; ex- shall provide at the plant, rooms, com- tent of examinations. partments, and equipment needed to maintain the identity of certified tech- (a) All processes used in the prepara- nical animal fats and materials used in tion of certified technical animal fats their preparation, and separation of at any certified plant shall be subject such articles from other products. Such to supervision by an inspector. Cer- rooms, compartments, and equipment tified plants shall not prepare any shall be conspicuously marked with the technical animal fat for certification phrase ‘‘Certified Technical Animal under the regulations in this part, ex- Fat’’ whenever they contain these fats. cept in accordance with such regulations. § 351.11 Identification and separation (b) Supervision, ranging from full- of technical animal fats for certifi- time coverage of an entire process to cation and materials for use there- one or more reviews per month, to de- in; removal of wrappers, etc.; clean- termine a plant’s compliance with the ing of equipment. regulations in this part will be main- (a) All technical animal fat to be of- tained. A circuit supervisor may in- fered for certification under this part crease the frequency of reviews when- and materials to be used in the prepa- ever he deems necessary to assure the ration of such fat, and all certified validity of certifications under the reg- technical animal fat, shall be identified ulations in this part. Usual coverage of and kept separate from other products individual rendering plants will be as from the time of receipt at a certified follows:

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(1) Coverage shall be at least once a § 351.17 Identification required. month if the plant consistently handles Certified technical animal fats being only raw materials acceptable under exported directly from a certified plant § 351.3 for the preparation of certified or transferred between certified plants technical animal fat and the plant op- for storage for export are subject to the erator, in writing, certifies that he is requirements of § 325.11 of this chapter. maintaining this procedure. In addition, such shipments between (2) Coverage shall be at least once a certified plants shall be accompanied week if the plant consistently handles by MP Form 85 (Declaration to Accom- some raw materials that are accept- pany Technical Animal Fats Between able, and some that are unacceptable, Certified Technical Animal Fat under § 351.3, for the preparation of cer- Plants) 2 prepared by the operator of tified technical animal fat, uses sepa- the certified plant from which ship- rate equipment for processing, and uses ment is made, certifying that the prod- separate rooms, compartments, and uct has been obtained by rendering raw equipment for receiving and storing materials derived from federally or the respective types of raw materials State inspected and passed carcasses, and technical animal fats, and the or parts of carcasses. Technical animal plant operator, in writing, certifies fat described on MP Form 85 as tallow that he is maintaining this complete must meet the definition of ‘‘Tallow’’ in § 351.2. physical separation procedure. (3) Coverage shall be fulltime during PROHIBITIONS receiving of raw materials and their preparation into certified technical § 351.18 Official identifications; unau- animal fat, if the plant handles some thorized use. raw materials that are acceptable, and (a) The form of certification set forth some that are unacceptable, under in § 351.3 and the term ‘‘Certified Tech- § 351.3, for the preparation of certified nical Animal Fat’’ are official identi- technical animal fat, and uses the same fications for purposes of the Agricul- rooms, compartments, and equipment, tural Marketing Act of 1946, as amend- with only time separation between reed, and shall not be falsely made, ceiving, processing, and storing the re- issued, altered, forged, or counter- spective types of raw materials and feited, or used for purpose of misrepre- technical animal fats. sentation or deception. (b) No container which bears or is to § 351.15 Reports of violations. bear any designation as certified technical animal fat shall be filled in whole Inspectors shall report to the circuit or in part, except with technical ani- supervisor any apparent violations of mal fats which have been certified and the regulations in this part or the Fed- identified in compliance with this part. eral Meat Inspection Act or regulations thereunder (subchapter A of this chap- REMEDIES; PENALTIES ter) which occur at certified plants, or elsewhere, within their knowledge. The § 351.19 Refusal of certification for circuit supervisor shall report such ac- specific lots. tions to the Administrator through ap- If an inspector has reason to believe propriate channels. that a lot of technical animal fat is ineligible for certification under § 351.3, TRANSPORTATION AND EXPORTATION OF or any materials to be used in a lot of CERTIFIED TECHNICAL ANIMAL FAT technical animal fat would make the technical animal fat ineligible for such § 351.16 Certificate required for ship- certification, certification of the lot ments of technical animal fat. shall be withheld pending final deter- No certified plant shall export any mination by the circuit supervisor. The certified technical animal fat unless operator of the plant shall be afforded the shipment is accompanied by a cer- 2 tificate issued under § 351.3. Copy filed as part of the original document.

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an opportunity to demonstrate the eli- in § 1.147(b) of the rules of practice (7 gibility of the lot for certification be- CFR 1.147(b)). fore the final determination is made. (c) The rules of practice of the De- partment of Agriculture in subpart H § 351.20 Withdrawal of service from of part I, subtitle A, title 7 of the Code certified plants. of Federal Regulations, are the rules of (a) After opportunity for hearing has practice applicable to adjudicatory, ad- been accorded the operator of a cer- ministrative proceedings under the reg- tified plant, the certification service, ulations in this part (9 CFR part 351). provided for in this part, may be withdrawn from such plant in accordance [40 FR 58627, Dec. 18, 1975, as amended at 43 with the applicable rules of practice, if FR 11148, Mar. 17, 1978] it is determined that: (1) The operator, or his employee or APPEALS agent: (i) Has made any willful misrepresen- § 351.21 Appeals. tation or engaged in any fraudulent or Any decision by an employee of the deceptive practice in connection with Program may be appealed by any ad- the service; versely affected person to the imme- (ii) Has interfered with or obstructed diate supervisor of such employee. De- any Program employee or other inspec- cisions of other inspectors may be ap- tor in the performance of his duties, pealed to the circuit supervisor. under the regulations in this part, by intimidation, threats, or other im- RECORDS AND REPORTS proper means; or (iii) Has violated section 203(h) of the § 351.22 Certified plants to maintain Agricultural Marketing Act of 1946, as records and make reports; access to amended (7 U.S.C. 1622(h)), or any regu- records. lation in this part; or (a) Each day a certified plant pre- (2) Facilities or procedures at the pares, receives, or ships certified tech- certified plant do not conform to the nical animal fat or receives material arrangements approved by the Admin- for use in such product, the operator of istrator under § 351.5. the plant shall prepare records identi- (b) Pending final determination of fying the kinds and quantities of such the matter, the Administrator may materials and technical animal fats re- summarily suspend the certification service at any certified plant when he ceived, the number of pounds of cer- has reason to believe that there is tified technical animal fat prepared or cause for withdrawal of the service shipped, and an up-to-date inventory of under paragraph (a). The operator of certified technical animal fats in stor- the certified plant shall be notified of age. The operator of each certified the Administrator’s decision to sus- plant shall include in the records re- pend summarily the certification serv- quired by this section all MP Forms 85 ice at such plant and the reasons there- which he receives with shipments of for, in writing, in the manner pre- certified technical animal fat from any scribed in § 1.147(b) of the rules of prac- other certified plant. These records tice (7 CFR 1.147(b)), or orally. The Ad- shall be maintained by the operator of ministrator’s decision to suspend sum- each certified plant and made available marily the certification service shall to an inspector, upon request, for ex- be effective upon such oral or written amination and copying, for a period of notification, whichever is earlier, to 1 year after the date of the transaction the operator of the certified plant. If involved. such notification is oral, the Adminis- (b) The operator of each certified trator shall confirm such decision, and plant shall provide such relevant infor- the reasons therefor, in writing, as mation as any inspector may request promptly as circumstances permit, and to enable him to determine whether such written confirmation shall be any technical animal fats are eligible served upon the operator of the cer- for certification and whether the plant tified plant, in the manner prescribed

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is eligible for certification service Act of 1946, as amended (60 Stat. 1087, under the regulations in this part. as amended; 7 U.S.C. 1621 et seq.). (b) Acceptable means suitable for the (Approved by the Office of Management and Budget under control number 0583–0036) purpose intended and acceptable to the Food Safety and Inspection Service. [40 FR 58627, Dec. 18, 1975, as amended at 47 (c) Antelope means any animal be- FR 746, Jan. 7, 1982] longing to the antelope family. (d) Applicant means any interested PART 352—EXOTIC ANIMALS AND party who requests any inspection HORSES; VOLUNTARY INSPECTION service. (e) Bison means any American bison Subpart A—Exotic Animals or catalo or cattalo. (f) Buffalo means any animal belong- Sec. ing to the buffalo family. 352.1 Definitions. 352.2 Type of service available. (g) Catalo or Cattalo means any hy- 352.3 Application by official exotic animal brid animal with American bison ap- establishment for inspection service. pearance resulting from direct cross- 352.4 Application for ante-mortem inspec- breeding of American bison and cattle. tion service in the field. (h) Condition means any condition, 352.5 Fees and charges. including, but not limited to, the state 352.6 Denial or withrawal of inspection serv- of preservation, cleanliness, or sound- ice. ness of any product or the processing, 352.7 Marking inspected products. handling, or packaging which may af- 352.8 Time of inspection in the field and in an official exotic animal establishment. fect such product. 352.9 Report of inspection work. (i) Condition and wholesomeness means 352.10 Ante-mortem inspection. the condition of any product, its 352.11 Post-mortem inspection. healthfulness and fitness for human 352.12 Disposal of diseased or otherwise food. adulterated carcasses and parts. (j) Deer means any member of the 352.13 Handling and disposal of condemned deer family. or other inedible exotic animal products (k) Exotic animal means any reindeer, at official exotic animal establishments. elk, deer, antelope, water buffalo or 352.14 Entry into official establishments; re- bison. inspection and preparation of products. 352.15 Records, registration and reports. (l) Elk means any American elk. 352.16 Exports. (m) Exotic animal inspection service 352.17 Transportation. means the personnel who are engaged 352.18 Cooperation of States in Federal pro- in the administration, application, and grams. direction of exotic animal inspection programs and services pursuant to the Subpart B—Horses regulations in this part. 352.19 Ante-mortem inspection and applica- (n) Exotic animal producer means any ble requirements. interested party that engages in the raising and/or marketing of an exotic AUTHORITY: 7 U.S.C. 1622, 1624; 7 CFR 2.17 (g) and (i), 2.55. animal for commercial purposes. (o) Field ante-mortem inspection means SOURCE: 50 FR 41847, Oct. 16, 1985, unless the ante-mortem inspection of an ex- otherwise noted. otic animal away from the official exotic animal establishment’s premises. Subpart A—Exotic Animals (p) Field designated area means any designated area on the applicant’s § 352.1 Definitions. premises, approved by the Regional Di- The definitions in § 301.2, not other- rector, where field ante-mortem in- wise defined in this part, are incor- spection is to be performed. porated into this part. In addition to (q) Identify means to apply official those definitions, the following defini- identification to products or con- tions will be applicable to the regula- tainers. tions in this part. (r) Inspection means any inspection (a) Act means the applicable provi- by an inspector to determine, in ac- sions of the Agricultural Marketing cordance with regulations in this part,

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(1) the condition and wholesomeness of § 352.2 Type of service available. an exotic animal, or (2) the condition Upon application, in accordance with and wholesomeness of edible product of §§ 352.3, 352.4, and 352.5, the following an exotic animal at any state of the type of service may be furnished under preparation or packaging in the official the regulations in this part: plant where inspected and certified, or (a) Voluntary Inspection Service. An (3) the condition and wholesomeness of inspection and certification service for any previously inspected and certified wholesomeness relating to the slaugh- product of an exotic animal if such ter and processing of exotic animals product has not lost its identity as an and the processing of exotic animal inspected and certified product. products. All provisions of this part (s) Interested party means any person shall apply to the slaughter of exotic financially interested in a transaction animals, and the preparation, labeling, involving any inspection. and certification of the exotic animal (t) Official exotic animal establishment meat and exotic animal products proc- means any slaughtering, cutting, essed under this exotic animal inspec- boning, curing, smoking, salting, pack- tion service. (b) Only exotic animals which have ing, rendering, or similar establish- had ante-mortem inspection as de- ment at which inspection is main- scribed under this part and which are tained under the regulations in this processed in official exotic animal es- part. tablishments in accordance with this (u) Official device means a stamping part may be marked inspected and appliance, branding device, stencil passed. printed label, or any other mechani- (c) Exotic animals, exotic animal cally or manually operated tool that is meat and meat food products shall be approved by the Administrator for the handled in an official exotic animal es- purpose of applying any official mark tablishment to ensure separation and or other identification to any product identity of the exotic animal or exotic or packaging material. animal meat and meat food products (v) Official identification means any until they are shipped from the official symbol, stamp, label or seal indicating exotic animal establishment to prevent that the product has been officially in- commingling with other species. spected and/or indicating the condition [54 FR 1330, Jan. 13, 1989] of the product approved and authorized by the Administrator to be affixed to § 352.3 Application by official exotic any product, or affixed to or printed on animal establishment for inspection the packaging material of any product. services. (w) Program means the Voluntary Ex- (a) Any person desiring to process an otic Animal Inspection Program of the exotic animal, exotic animal carcasses, Food Safety and Inspection Service. exotic animal meat and meat food (x) Reindeer means any reindeer com- products in an establishment under ex- monly referred to as caribou. otic animal inspection service must re- (y) Transport vehicle means any vehi- ceive approval of such establishment cle used to transport an exotic animal. and facilities as an official exotic animal establishment prior to the ren- (z) Veterinarian means an authorized dition of such service. An application veterinarian of the Program employed for inspection service to be rendered in by the Department or any cooperating an official exotic animal establishment State who is authorized by the Sec- shall be approved in accordance with retary to do any work or perform any the provisions contained in §§ 304.1 and duty in connection with the Program. 304.2 of subchapter A of this chapter. (aa) Water buffalo means any Asiatic (b) Initial survey. When an applica- water buffalo, commonly referred to as tion has been filed for exotic animal in- carabao; and the water buffalo of India, spection service, the Regional Director commonly referred to as the Indian or designee, shall examine the estab- buffalo. lishment, premises, and facilities. [54 FR 1330, Jan. 13, 1989] [54 FR 1331, Jan. 13, 1989]

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§ 352.4 Application for ante-mortem including Saturdays, Sundays, and holi- spection service in the field. days; and for certain laboratory serv- Any exotic animal producer desiring ices which are not covered under the field ante-mortem exotic animal in- base time, overtime, and/or holiday spection service must receive approval costs. Such fees shall cover the costs of of the field ante-mortem designated the service and shall be charged for the area from the Regional Director or des- time required to render such service, ignee prior to the rendition of such including, but not limited to, the time required for the travel of the inspector service. An application seeking ap- or inspectors in connection therewith proval of the designated area for ante- during the regularly scheduled admin- mortem inspection shall be obtained istrative workweek. from the Regional Director, and com- (d) Charges may also be made to pleted and submitted to the Regional cover other expenses incurred by the Director. Service in connection with the fur- (a) An initial application for field nishing of the service. ante-mortem exotic animal inspection (e) Fees and charges for any inspec- service shall be made by an official ex- tion pursuant to a cooperative agree- otic animal establishment to the Re- ment with any State shall be paid in gional Director. Subsequent requests accordance with the terms of such co- shall be made by the official exotic ani- operative agreement. mal establishment on behalf of an exotic animal producer to the Regional [50 FR 41847, Oct. 16, 1988, as amended at 53 Director in one of the following man- FR 13398, Apr. 22, 1988; 54 FR 6390, Feb. 10, ners: (1) telephone, (2) telegraph, (3) 1989] mail, or (4) in person as determined by § 352.6 Denial or withdrawal of inspec- the Regional Director. tion service. (b) Upon receipt of the completed application, the Regional Director or des- (a) For miscellaneous reasons. An ap- ignee shall examine the field ante- plication or a request for service may mortem designated area and facilities be rejected, or the benefits of the serv- for approval of the designated area. ice may be otherwise denied to, or (c) All fees involved for the approval withdrawn from, any person, without a of the designated area, including but hearing by the appropriate Regional not limited to any travel, per diem Director: (1) for administrative reasons costs, and time required to perform such as the nonavailability of per- such approval services, shall be paid di- sonnel to perform the service; (2) for rectly by the applicant to the Regional the failure of payment for service; (3) Director. in case the application or request relates to exotic animals or exotic ani- [54 FR 1331, Jan. 13, 1989] mal products which are not eligible for service under this part; (4) for failure § 352.5 Fees and charges. to maintain the designated area or the (a) Fees and charges for service under plant in a state of repair approved by the regulations in this part shall be the Service; (5) for the use of operating paid by the applicant for the service in procedures which are not in accordance accordance with this section. with the regulations of this part; (6) for (b) The fees and charges provided for alterations of buildings, facilities, or in this section shall be paid by check, equipment which cannot be approved draft, or money order payable to the under the regulations in this part. No- ‘‘Treasurer of the United States’’ and tice of such rejection, denial, or with- shall be remitted promptly to the Re- drawal, and the reasons therefore, shall gional Director upon furnishing to the promptly be given to the person in- applicant a statement as to the volved. The applicant or recipient shall amount due. be notified of such decision to reject an (c) The fees to be charged and col- application or request for service or to lected for service under the regulations deny or withdraw the benefits of the in this part shall be at the rates speci- service, and the reasons therefor, in fied in §§ 391.2, 391.3, and 391.4 respec- writing in the manner prescribed in tively for base time; for overtime in- § 1.147(b) of the rules of practice (7 CFR

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1.147(b)), or orally. Such decision shall a person or entity, from whom the ben- be effective upon such oral or written efits of the service are currently being notification, whichever is earlier, to denied or have been withdrawn under the applicant or recipient. If such noti- this part; or by a person or entity hav- fication is oral, the person making ing an officer, director, partner, man- such decision shall confirm such deci- ager or substantial investor from sion, and the reasons therefor, in writ- whom the benefits of service under this ing, as promptly as circumstances per- part are currently being denied or have mit, and such written confirmation been withdrawn under this part, and shall be served upon the applicant or who has any authority with respect to recipient in the manner prescribed in the location where service is or would § 1.147(b) of the rules of practice (7 CFR be performed; or in case the service is 1.147(b)). or would be performed with respect to (b) For disciplinary reasons—Basis for any exotic animal or exotic animal denial or withdrawal. An application or product in which any person or entity, request for service may be denied, or from whom the benefits of service are the benefits of the service may be with- currently being denied or have been drawn from, any person or entity who, withdrawn under this part, has con- or whose officer, employee or agent in tract or other financial interest. the scope of his employment or agency: (c) Procedure. (1) An application or re- (1) Has willfully made any misrepresen- quest for service may be denied or ben- tation or has committed any other efits of the service may be withdrawn fraudulent or deceptive practice in con- by the Secretary, as provided by para- nection with any application or request graph (b) of this section, after notice for service under this part; (2) has and opportunity for hearing before a given or attempted to give, as a loan or for any other purpose, any money, designated official of the Department. favor or other thing of value, to any The Administrator may suspend serv- employee or agent of the Department ice under this paragraph without hear- or a cooperating State authorized to ing, pending final determination of the perform any function under this part; matter, when he determines that the (3) has interfered with or obstructed, or public health, interest or safety so re- attempted to interfere with or to ob- quires. The applicant or recipient shall struct, any employee or agent of the be notified of the Administrator’s deci- Department or cooperating State in sion to suspend service, and the rea- the performance of his or her duties sons therefor, in writing or orally. The under this part by intimidation, Administrator’s decision to suspend threats, assaults, abuse, or any other service under this part shall be effec- improper means; (4) has knowingly rep- tive upon such an oral or written noti- resented that any exotic animal car- fication, whichever is earlier, to the cass, or exotic animal product, has applicant or recipient. If such notifica- been officially inspected and passed by tion is oral, the Administrator shall an authorized inspector under this confirm such decision, and the reasons part, when it had not, in fact, been so therefor, in writing, as promptly as cir- inspected; (5) has been convicted of cumstances permit, and such written more than one misdemeanor under any confirmation shall be served upon the law based upon the acquiring, han- applicant or recipient in the manner dling, or distributing of adulterated, prescribed in 1.147(b) of Departmental mislabeled, or deceptively packaged rules of practice (7 CFR 1.147(b)). good, or fraud in connection with (2) The written notification specified transactions in food, or any felony; in paragraph (c) of this section, which Provided, an application or a request shall constitute the complaint in the for service made in the name of a per- proceeding, shall briefly set forth the son or entity otherwise eligible for reason for the denial or withdrawal of service under the regulations may be service, including allegations of fact denied, or the benefits of the service which constitute a basis for the action. may be withdrawn, from such a person After the complaint is served upon the or entity in case the service is or would respondent, as provided in § 1.147(b) of be performed at a location operated by Departmental rules of practice (7 CFR

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1.147(b)), the proceeding shall there- (a) The inspection mark to be applied after be conducted in accordance with to inspected and passed carcasses and rules of practice which shall be adopted parts of carcasses of an exotic animal, for the proceeding. and products as therefrom approved by the Administrator, shall be in the form [50 FR 41847, Oct. 16, 1985, as amended at 54 FR 1331, Jan. 13, 1989] and arrangement as indicated in the example below. 1 The establishment § 352.7 Marking inspected products. number of the official establishment Wording and form of inspection shall be set forth if it does not appear mark. Except as otherwise authorized on the packaging material or con- by the Administrator, the inspection tainer. mark applied to inspected and passed (1) For application to exotic animal exotic animal carcasses, meat or meat carcasses, primal parts and cuts there- food products under this part shall in- from, exotic animal livers, exotic ani- clude wording as follows: ‘‘Inspected mal tongues, and exotic animal hearts. and Passed by U.S. Department of Ag- riculture.’’ This wording shall be contained within a triangle in the form and arrangement shown in this section. The establishment number of the official establishment shall be included in the triangle unless it appears elsewhere on the packaging material. Ordering and manufacture of the triangle brand shall be in accordance with the provisions in 9 CFR 317.3(c) of the Federal meat inspection regulations. The Ad- ministrator may approve the use of abbreviations of such inspection mark, and such approved abbreviations shall have the same force and effect as the inspection mark. The inspection mark or approved abbreviation shall be applied, under the supervision of the inspector, to the inspected and passed ed- (2) For application to exotic animal ible product, packaging material, im- calf carcasses. mediate container or shipping container. When the inspection mark or approved abbreviation is used on packaging material, immediate container or shipping container, it shall be printed on such material or container or on a label to be affixed to the packaging material or container. The name and address of the packer or distributor of such product shall be printed on the packaging material or label. The inspection marks may be stenciled on the container, and when the inspection mark is so stenciled, the name and address of the packer or distributor may be applied by the use of a stencil or rubber stamp. The name and address of the packer or distributor, if prominently shown elsewhere on the pack- 1 The number ‘‘38’’ is given as an example aging material or container, may be only. The establishment number of the offi- omitted from insert labels which bear cial exotic animal establishment where the an official identification if the applica- product is prepared shall be used in lieu ble establishment number is shown. thereof.

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(3) For application to exotic animal tails.

(4) For application to burlap, muslin, cheesecloth, heavy paper, or other acceptable material that encloses carcasses or parts of carcasses. (2) This official mark shall be applied by mechanical means and shall not be applied by a hand stamp. (3) The official inspection legend described in paragraph (b)(1) of this section shall also be used on shipping containers, bond labels, artificial casings, and other articles with the approval of the Administrator. (c) Any brand, stamp, label or other device approved by the Administrator and bearing any official mark prescribed in paragraph (a) or (b) of this section shall be an official device for purposes of the Act. [50 FR 41847, Oct. 16, 1985, as amended at 54 FR 1331, Jan. 13, 1989]

§ 352.8 Time of inspection in the field and in an official exotic animal es- (b) The official inspection mark to be tablishment. shown on all labels. 1 (1) For inspected The official exotic animal establish- and passed products of an exotic ani- ment on behalf of the applicant shall mal shall be in the following form, ex- notify the Regional Director or des- cept that it need not be of the size il- ignee, in advance, of the hours when lustrated, provided that it is a suffi- such inspection is desired. Inspection cient size and of such color as to be personnel shall have access at all times conspicuously displayed and readily to every part of any field ante-mortem legible and the same proportions of let- inspection area and/or official exotic ter size and boldness are maintained as animal establishment to which they illustrated: are assigned. [54 FR 1332, Jan. 13, 1989]

§ 352.9 Report of inspection work. Reports of the work of inspection 1 The number ‘‘38’’ is given as an example carried on within the field ante- only. The establishment number of the offi- mortem inspection area of an exotic cial exotic animal establishment where the animal producer’s premises and/or offi- product is prepared shall be used in lieu cial exotic animal establishment shall thereof. be forwarded to the Administrator by

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the ante-mortem inspector. The appli- not pass ante-mortem inspection must cant for such inspection shall furnish be withheld from slaughter. to the Administrator such information (5) Stunning to render the animal un- as may be required on forms provided conscious shall be in accordance with 9 by the Administrator. CFR 313.15 or 313.16. [54 FR 1333, Jan. 13, 1989] (6) All stunned/slaughtered and bled exotic animals shall be tagged with a § 352.10 Ante-mortem inspection. ‘‘U.S. Suspect’’ tag in an ear by the An ante-mortem inspection of an ex- ante-mortem inspector or designee otic animal shall, where and to the ex- prior to loading on the transport vehi- tent considered necessary by the Ad- cle. ministrator and under such instruc- (7) The transport of intact exotic ani- tions as he may issue from time to mal carcasses to an official exotic ani- time, be made on the day of slaughter mal establishment for post-mortem in- of an exotic animal, in one of the fol- spection shall be as expedient as pos- lowing listed ways or as determined by sible, and must be within the same day the Administrator. Humane handling as field slaughter. of an exotic animal during ante- mortem inspection shall be in accord- (8) Ante-mortem cards (Form MP 402– ance with the provisions contained in 9 2) shall be filled out by the ante- CFR 313.2. Immediately after the ani- mortem inspector. One copy is to be re- mal is stunned or killed, it shall be tained by the ante-mortem inspector. shackled, hoisted, stuck and bled. The other copy shall accompany the (a) To be performed on an exotic ani- transport vehicle to the official exotic mal in the field in a designated area of animal establishment and shall be de- an exotic animal producer’s premises. livered to the post-mortem veteri- (1) Reindeer, elk, deer, antelope, narian. bison and water buffalo are eligible for (9) The ante-mortem inspector shall field ante-mortem inspection. The field supervise all phases of field ante- ante-mortem designated area must be mortem inspection. approved by the Regional Director or (b) To be performed on exotic ani- designee prior to rendition of the serv- mals that are inside of the transport ice. vehicle at an official exotic animal es- (2) Any person who desires to receive tablishment. field ante-mortem inspection must provide: (1) Reindeer, elk, deer, antelope, (i) Notification from an official ex- bison, and water buffalo are eligible for otic animal establishment to the Re- transport vehicle inspection. gional Director or designee. (2) The ante-mortem inspector shall (ii) A field ante-mortem designated remain outside the transport vehicle area. while performing ante-mortem inspec- (iii) A stunning/slaughtering area tion. which is in a condition that minimizes (3) The person requesting transport the possibility of soiling the animal vehicle inspection must provide a when stunned/slaughtered and bled as transport vehicle that is as sanitary as determined by the inspector. practicable and that would safely and (iv) A transport vehicle that is as thoroughly permit the inspection of an sanitary as practicable as determined exotic animal from outside of the by the inspector. transport vehicle as determined by the (3) The ante-mortem inspector shall inspector. determine the acceptableness and safe- (4) The ante-mortem inspector shall ty of performing field ante-mortem inspection. If, in the opinion of the ante- determine the adequacy and safety of mortem inspector, an unsafe cir- performing ante-mortem inspection. If, cumstance exists at the time of field in the ante-mortem inspector’s opin- ante-mortem inspection, the service ion, the transport vehicle is not ade- shall be denied. quate or safe to perform ante-mortem (4) An exotic animal that, in the inspection, the service shall be denied. ante-mortem inspector’s opinion, does

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(c) To be performed in pens at official § 352.16 Exports. exotic animal establishments. The in- This shall be conducted in accord- spection shall be conducted in accordance with the provisions contained in 9 ance with the provisions contained in 9 CFR part 309. CFR 322.1 through 322.5. [54 FR 1333, Jan. 13, 1989] § 352.17 Transportation.

§ 352.11 Post-mortem inspection. This shall be conducted in accordance with the provisions contained in (a) Post-mortem inspection of rein- §§ 325.1 through 325.21. deer, elk, deer, antelope, bison and water buffalo shall be conducted in ac- § 352.18 Cooperation of States in Fed- cordance with the provisions contained eral programs. in 9 CFR part 310 or as determined by the Administrator. Under the ‘‘Talmadge-Aiken Act’’ of (b) The post-mortem examination of September 28, 1962 (7 U.S.C. 450), the field ante-mortem-inspected exotic ani- Administrator is authorized to utilize mals must occur in the shortest length employees and facilities of States in of time practicable and on the day that carrying out Federal functions. field ante-mortem inspection is performed to minimize the changes in the Subpart B—Horses carcass which can affect the post- mortem examination, disposition and § 352.19 Ante-mortem inspection and wholesomeness of the carcass and its applicable requirements. parts. Notwithstanding part 309 of this sub- (c) The post-mortem veterinarian chapter, an official establishment that shall inspect and make the disposition wishes to slaughter horses can apply of all incoming ‘‘U.S. Suspect’’ tagged for voluntary ante-mortem inspection exotic animals. according to § 352.3. Such establish- [54 FR 1333, Jan. 13, 1989] ments shall pay the applicable base time, overtime, and holiday rates for § 352.12 Disposal of diseased or other- ante-mortem inspection in accordance wise adulterated carcasses and with § 352.5. Such ante-mortem inspec- parts. tion shall be made in pens on the prem- This shall be conducted in accord- ises of the establishment at which the ance with the provisions contained in 9 horses are offered for slaughter in ac- CFR part 311. cordance with § 309.1(b), and such establishments also shall comply with all § 352.13 Handling and disposal of condemned or other inedible exotic applicable provisions of §§ 352.8 and animal products at official exotic 352.9. If the establishment complies animal establishments. with all these requirements for ante- This shall be conducted in accord- mortem inspection, FSIS will conduct ance with the provisions contained in 9 ante-mortem inspection at that estab- CFR part 314. lishment in accordance with § 352.10, and all other provisions in part 309 of § 352.14 Entry into official establish- this subchapter that pertain to horses ments; reinspection and prepara- will apply. FSIS may deny or withdraw tion of products. ante-mortem inspection services at of- This shall be conducted in accord- ficial establishments that slaughter ance with the provisions contained in 9 horses for any applicable reason under CFR 318.1, 318.2, and 318.3. § 352.6. Official marks and devices to identify inspected and passed horse § 352.15 Records, registration, and re- carcasses and parts of carcasses, or ports. horse meat food products shall be those This shall be conducted or main- in § 312.3 of this subchapter. tained in accordance with the provisions contained in 9 CFR 320.1 through [71 FR 6341, Feb. 8, 2006] 320.7.

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PART 354—VOLUNTARY INSPEC- 354.65 Form of inspection mark. TION OF RABBITS AND EDIBLE SUPERVISION OF MARKING AND PACKAGING PRODUCTS THEREOF 354.70 Evidence of label approval. 354.71 Affixing of official identification. GENERAL 354.72 Packaging. Sec. 354.73 Retention labels. 354.1 Definitions. 354.74 Prerequisites to inspection. 354.2 Designation of official certificates, 354.75 Accessibility of products. memoranda, marks, other identifica- 354.76 Time of inspection in an official tions, and devices for purposes of the Ag- plant. ricultural Marketing Act. REPORTS ADMINISTRATION 354.90 Report of inspection work. 354.3 Administration. 354.91 Information to be furnished to inspectors. BASIS OF SERVICE 354.92 Reports of violations. 354.10 Inspection service. 354.12 Eligibility. FEES AND CHARGES 354.13 Supervision. 354.100 Payment of fees and charges. 354.14 Authority to waive provisions of 354.101 On a fee basis. § 354.12. 354.105 Fees for additional copies of inspec- PERFORMANCE OF SERVICES tion certificates. 354.106 Travel expenses and other charges. 354.20 Licensed or authorized inspectors. 354.107 Continuous inspection performed on 354.21 Suspension of license; revocation. a resident basis. 354.22 Surrender of license. 354.109 Fees or charges for inspection serv- 354.23 Identification. ice performed under cooperative agree- 354.24 Financial interest of inspectors. ment. 354.25 Political activity. 354.110 Disposition of fees for inspection 354.26 Schedule of operation of official made under cooperative agreement. plants. INSPECTION PROCEDURES; ANTE-MORTEM PPLICATION FOR NSPECTION ERVICE A I S INSPECTIONS 354.30 Who may obtain inspection service. 354.120 Manner of handling products in an 354.31 How application for service may be official plant. made; conditions of resident service. 354.121 Ante-mortem inspection. 354.32 Filing of application. 354.122 Condemnation on ante-mortem in- 354.33 Authority of applicant. spection. 354.34 Application for inspection service in 354.123 Segregation of suspects on ante- official plants; approval. mortem inspection. 354.35 Rejection of application. 354.124 Quarantine of diseased rabbits. 354.36 Withdrawal of application. 354.38 Suspension of plant approval. POST-MORTEM INSPECTION VIOLATIONS 354.125 Evisceration. 354.45 Denial of service. 354.126 Carcasses held for further examina- 354.46 Misrepresentation; deceptive or tion. fraudulent acts or practices. 354.127 Condemnation and treatment of car- 354.47 Use of facsimile forms. casses. 354.48 Willful violation of the regulations. 354.128 Certification of carcasses. 354.49 Interfering with an inspector or em- DISPOSITION OF DISEASED RABBIT CARCASSES ployee of Service. AND PARTS 354.51 Miscellaneous. 354.129 General. OTHER APPLICABLE REGULATIONS 354.130 Diseases or conditions evident which 354.53 Other applicable regulations. require condemnation. 354.131 Decomposition. IDENTIFYING AND MARKING PRODUCTS 354.132 Disposal of condemned carcasses and 354.60 Approval of official identification. parts. 354.62 Inspection mark with respect to prod- REINSPECTION AND INGREDIENTS uct. 354.63 Marking inspected products. 354.133 Reinspection of edible products; in- 354.64 Form of official identification. gredients.

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APPEALS GENERAL 354.134 Appeal inspections; how made. § 354.1 Definitions. INSPECTION CERTIFICATES Unless the context otherwise re- 354.140 Forms of inspection certificates. quires, the following terms shall have 354.141 Issuance and disposition of rabbits the following meaning: inspection certificates. (a) Act means the applicable provi- 354.142 Food product inspection certificates; sions of the Agricultural Marketing issuance and disposition. Act of 1946 (60 Stat. 1087; 7 U.S.C. 1621 354.143 Export certificates; issuance and dis- et seq.) or any other act of Congress position. conferring like authority. 354.144 Advance information. (b) Acceptable means suitable for the BASIS OF ACCEPTABILITY OF OTHER OFFICIAL purpose intended and acceptable to the INSPECTION SYSTEMS Service. 354.160 General. (c) Administrator means the Adminis- 354.161 Requirements as to manner of in- trator of the Food Safety and Inspec- spection. tion Service of the Department or any 354.162 Determining compliance with other officer or employee of the De- § 354.161. partment to whom there has heretofore been delegated, or to whom there may SANITARY REQUIREMENTS hereafter be delegated the authority to GENERAL act in his stead. (d) Applicant means any interested 354.210 Minimum standards for sanitation, party who requests any inspection facilities, and operating procedures in official plants. service. (e) Area supervisor means any em- BUILDINGS AND PLANT FACILITIES ployee of the Department in charge of 354.220 Buildings. rabbit inspection service in a des- 354.221 Rooms and compartments. ignated geographical area. 354.222 Floors, walls, ceilings, etc. (f) Carcass means any rabbit carcass. 354.223 Drainage and plumbing. (g) Circuit supervisor or technical su- 354.224 Water supply. pervisor means the officer in charge of 354.225 Lavatory accommodations. the rabbit inspection service in a cir- 354.226 Lighting and ventilation. cuit consisting of a group of stations within an area. EQUIPMENT AND UTENSILS (h) Class means any subdivision of a 354.230 Equipment and utensils. product based on essential physical 354.231 Accessibility. characteristics that differentiate be- 354.232 Restrictions on use. tween major groups of the same kind.

MAINTENANCE OF SANITARY CONDITIONS AND (i) Condition means any condition, in- PRECAUTIONS AGAINST CONTAMINATION OF cluding, but not being limited to, the PRODUCTS state of preservation, cleanliness, or soundness, of any product or the proc- 354.240 General. 354.241 Cleaning of rooms and compart- essing, handling, or packaging which ments. may affect such product. 354.242 Cleaning of equipment and utensils. (j) Condition and wholesomeness means 354.243 Operations and procedures. the condition of any product, its 354.244 Temperatures and cooling and freez- healthfulness and fitness for human ing procedures. food. 354.245 Vermin. (k) Department means the United 254.246 Exclusion of diseased persons. States Department of Agriculture. 354.247 Table showing types of materials. (l) Edible product means any product 354.248 Scope and applicability of rules of derived from ready-to-cook domestic practice. rabbits. AUTHORITY: 7 U.S.C. 1622, 1624; 7 CFR 2.17 (m) Giblets means the liver from (g) and (i), 2.55. which the bile sac has been removed SOURCE: 41 FR 23702, June 11, 1976, unless and the heart from which the peri- otherwise noted. cardial sac has been removed.

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(n) Holiday or legal holiday shall mean able and adequate for operation under the legal public holidays specified by inspection service and in which inspec- the Congress in paragraph (a) of section is carried on in accordance with tion 6103, Title 5, of the United States the regulations in this part. Code. (w) Person means any individual, (o) Identify means to apply official partnership, association, business identification to products or to con- trust, corporation, or any organized tainers thereof. group of persons, whether incorporated (p) Inspected and certified or certified or not. means, with respect to any product, (x) Potable water means water that that it has undergone an inspection has been approved by the State health and was found, at the time of such in- authority as safe for drinking and suit- spection, to be sound, wholesome, and able for food processing. fit for human food. (y) Product means ready-to-cook (q) Inspection, inspection service, or in- cooked rabbits, or edible products de- spection of products for condition and rived therefrom. wholesomeness means any inspection by (z) Rabbit means any domesticated an inspector to determine, in accord- rabbit, whether live or dead. ance with the regulations in this part, (aa) Rabbit inspection service means (1) the condition and wholesomeness of the personnel who are engaged in the rabbits, or (2) the condition and whole- administration, application, and direc- someness of any edible product at any tion of rabbit inspection programs and state of the preparation or packaging services pursuant to the regulations in thereof in the official plant where in- this part. spected and certified, or (3) the condi- (bb) Ready-to-cook domestic rabbit tion and wholesomeness of any pre- means any rabbit which has been viously inspected and certified product slaughtered for human food, from if such product has not lost its identity which the head, blood, skin, feet, and as an inspected and certified product. inedible viscera have been removed, (r) Inspection certificate means a that is ready to cook without need of statement, either written or printed, further processing. Ready-to-cook rab- issued by an inspector, pursuant to the bit also means any cut-up or disjointed regulations in this part, relative to the portion of rabbit or any edible part condition and wholesomeness of prod- thereof, as described in this paragraph. (cc) Regulations means the provisions ucts. of this entire part as may be in effect (s) Inspector means any person who is at the time inspection is performed. licensed by the Secretary to inves- (dd) Secretary means the Secretary of tigate and certify, in accordance with the Department, or any other officer or the regulations in this part, the condi- employee of the Department to whom tion and wholesomeness of products. there has heretofore been delegated, or An inspector is an employee of the De- to whom there may hereafter be dele- partment or of a State; he may be a gated, the authority to act in his stead. graduate veterinarian or a layman. (ee) Service means the Food Safety (t) Interested party means any person and Inspection Service of the Depart- financially interested in a transaction ment. involving any inspection. (ff) Station supervisor means any au- (u) National supervisor means (1) the thorized individual who is designated officer in charge of the rabbit inspec- to supervise rabbit inspection service tion service of the Food Safety and In- in a large official plant or in a group of spection Service, and (2) other officers several small plants. or employees of the Department designated by the officer in charge of the § 354.2 Designation of official certifi- rabbit inspection service of the Food cates, memoranda, marks, other Safety and Inspection Service. identifications, and devices for pur- (v) Official plant means one or more poses of the Agricultural Marketing buildings or parts thereof, comprising a Act. single plant in which the facilities and Subsection 203(h) of the Agricultural methods of operation therein have been Marketing Act of 1946, as amended by approved by the Administrator as suit- Pub. L. 272, 84th Congress, provides

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criminal penalties for various specified ADMINISTRATION offenses relating to official certificates, memoranda, marks or other § 354.3 Administration. identifications, and devices for making The Administrator shall perform, for such marks or identifications, issued or and under the supervision of the Sec- authorized under section 203 of said retary, such duties as are prescribed in Act, and certain misrepresentations the regulations in this part and as the concerning the inspection of agricul- Secretary may require in the adminis- tural products under said section. For tration of the regulations in this part. the purposes of said subsection and the The Administrator is authorized to provisions in this part, the terms listed waive for limited periods any par- in this section shall have the respec- ticular provisions of the regulations to tive meanings specified: permit experimentation so that new (a) Official certificate means any form procedures, equipment, and processing of certification, either written or print- techniques may be tested to facilitate ed, used under this part to certify with definite improvements and, at the respect to the inspection or class or same time, to assure full compliance condition of products. with the spirit and intent of the regu- (b) Official memorandum means any lations. The Food Safety and Inspec- initial record of findings made by an tion Service and its officers and em- authorized person in the process of in- ployees shall not be liable in damages specting or sampling, pursuant to this through acts of commission or omis- part, any processing or plant operation sion in the administration of this part. report made by an authorized person in BASIS OF SERVICE connection with inspecting or sampling under this part, and any report made § 354.10 Inspection service. by an authorized person of services per- Any inspection service in accordance formed pursuant to this part. with the regulations in this part shall (c) Official mark means the inspection be for condition and wholesomeness. mark, and any other mark, or any variations in such marks, approved by the § 354.12 Eligibility. Administrator and authorized to be af- (a) Only rabbits which are processed fixed to any product, or affixed to or in official plants in accordance with printed on the packaging material of the regulations in this part may be in- any product, stating that the product spected. was inspected, or indicating the condi- (b) All rabbits that are eviscerated in tion of the product, or for the purpose an official plant where inspection serv- of maintaining the identity of products ice is maintained shall be inspected for inspected under this part, including, condition and wholesomeness and no but not limited to, that set forth in dressed rabbits or uninspected products § 354.65. shall be brought into such official (d) Official identification means any plant. symbol, stamp, label, or seal indicating that the product has been officially in- § 354.13 Supervision. spected and/or indicating the class or All inspection service shall be sub- condition of the product approved by ject to supervision at all times by the the Administrator and authorized to be station supervisor, circuit supervisor, affixed to any product, or affixed to or area supervisor, and national super- printed on the packaging material of visor. Such service shall be rendered any product. where the facilities and conditions are (e) Official device means a stamping satisfactory for the conduct of the appliance, branding device, stencil, service and the requisite inspectors are printed label, or any other mechani- available. cally or manually operated tool that is approved by the Administrator for the § 354.14 Authority to waive provisions purpose of applying any official mark of § 354.12. or other identification to any product The Administrator is authorized to or the packaging material thereof. waive the provisions of § 354.12 which

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pertain to the entry of uninspected edi- ocation. When no appeal is filed within ble products into official plants in spe- the prescribed 7 days, the license to cific instances where rabbits are to be perform inspection service is revoked. brought into compliance with a law under the provisions of a court order. § 354.22 Surrender of license. Such rabbits shall be handled in an of- Each license which is suspended, or ficial plant in accordance with such revoked, or has expired shall promptly procedures as the Administrator may be surrendered by the licensee to his prescribe to insure proper segregation immediate superior. Upon termination and identity of the rabbits or rabbit of the services of a licensed inspector, products until they are shipped from the licensee shall promptly surrender the official plant. his license to his immediate superior.

PERFORMANCE OF SERVICES § 354.23 Identification. § 354.20 Licensed or authorized inspec- Each inspector shall have in his pos- tors. session at all times, and present upon (a) Any person who is a Federal or request while on duty, the means of State employee or the employee of a identification furnished by the Depart- local jurisdiction possessing proper ment to such person. qualifications as determined by an ex- § 354.24 Financial interest of inspec- amination for competency, and who is tors. to perform inspection service under this part may be licensed or otherwise No inspector shall render service on authorized by the Secretary as an in- any product in which he is financially spector. interested. (b) All licenses issued by the Sec- retary shall be countersigned by the of- § 354.25 Political activity. ficer in charge of the rabbit inspection All inspectors are forbidden, during service of the Animal and Plant Health the period of their respective appoint- Inspection Service or any other des- ments or licenses, to take an active ignated officer of such Service. part in political management or in political campaigns. Political activity in § 354.21 Suspension of license; revoca- city, county, State, or national elec- tion. tions, whether primary or regular, or Pending final action by the Sec- in behalf of any party or candidate, or retary, any person authorized to coun- any measure to be voted upon, is pro- tersign a license to perform inspection hibited. This applies to all appointees, service may, whenever he deems such including, but not being limited to, action necessary to assure that any in- temporary and cooperative employees spection service is properly performed, and employees on leave of absence with suspend any license to perform inspec- or without pay. Willful violation of tion service issued pursuant to this §§ 354.20 to 354.25 will constitute part, by giving notice of such suspen- grounds for dismissal in the case of ap- sion to the respective licensee, accom- pointees and revocation of licenses in panied by a statement of the reasons the case of licensees. therefor. Within 7 days after the receipt of the aforesaid notice and state- § 354.26 Schedule of operation of offi- ment of reasons, the licensee may file cial plants. an appeal in writing, with the Sec- Inspection operating schedules for retary, supported by any argument or services performed pursuant to § 354.107 evidence that he may wish to offer as shall be requested in writing and be ap- to why his license should not be fur- proved by the Administrator. Normal ther suspended or revoked. After the operating schedules for a full week expiration of the aforesaid 7–day period consist of a continuous 8-hour period and consideration of such argument per day (excluding not to exceed 1 hour and evidence, the Secretary will take for lunch), 5 consecutive days per week, such action as he deems appropriate within the period of Monday through with respect to such suspension or rev- Saturday, for each shift required. Less

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than 8-hour schedules may be re- service rendered a corporation for its quested and will be approved if an in- general benefit. spector is available. Sundays may not be approved in any tour of duty. Clock § 354.32 Filing of application. hours of daily operations need not be An application for inspection service specified in the request, although as a shall be regarded as filed only when condition of continued approval, the made pursuant to the regulations in hours of operation shall be reasonably this part. uniform from day to day. Inspectors are to be notified by management 1 day § 354.33 Authority of applicant. in advance of any change in the hours Proof of the authority of any person inspection service is requested. applying for inspection service may be APPLICATION FOR INSPECTION SERVICE required at the discretion of the Ad- ministrator. § 354.30 Who may obtain inspection service. § 354.34 Application for inspection service in official plants; approval. An application for inspection service 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 inspec- United States, any State, county, mu- tion service must receive approval of nicipality, or common carrier, and any such plant and facilities as an official authorized agent of the foregoing. plant prior to the rendition of such service. An application for inspection § 354.31 How application for service service to be rendered in an official may be made; conditions of resident plant shall be approved according to service. the following procedure: (a) On a fee basis. An application for (a) Initial survey. When application any inspection service on a fee basis has been filed for inspection service as may be made in any office of inspec- aforesaid, the area supervisor, or his tion or with any inspector at or nearest assistant, shall examine the plant, the place where the service is desired. premises, and facilities and shall speci- Such application may be made orally fy any additional facilities required for (in person or by telephone), in writing, the service. Appeals with respect to or by telegraph. If the application for any such specification may be made to inspection service is made orally, the the national supervisor. office of inspection or the inspector (b) Drawings and specifications to be with whom the application is made, or furnished in advance of construction or the Administrator, may require that alterations. the application be confirmed in writ- (1) Four copies of drawings or blue- ing. prints showing the features specified (b) On a resident inspection basis. An herein shall be submitted to the Ad- application for resident inspection ministrator. The drawings or blue- service must be made in writing on prints shall be legible, made with forms approved by the Administrator sharp, clear lines, and properly drawn and filed with the Administrator. Such to scale, and shall consist of floor plans forms may be obtained at the national, and a plot plan. area, or State inspection office. In (2) The plot plan shall show such fea- making application, the applicant tures as the limits of the plant’s prem- agrees to comply with the terms and ises, locations in outline of buildings conditions of the regulations (includ- on the premises, one point of the coming, but not being limited to, such in- pass, and roadways and railroads serv- structions governing inspection of ing the plant. products as may be issued from time to (3) The floor plan shall show all space time by the Administrator). No mem- to be included in the official plant. If ber of or delegate to Congress or Resi- rooms or compartments shown on the dent Commissioner shall be admitted drawings or blueprints are not to be in- to any benefit that may arise from cluded as part of the official plant, this such service unless derived through shall be clearly indicated thereon.

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(4) The sheets of paper on which with other suitable devices against en- drawings or blueprints are made shall trance of flies or other insects. not exceed a size 34″ × 44″. The drawings (6) Finish of floors—concrete, brick, other than of the plot plan shall be mastic material, etc. made to a scale of 1⁄8″ per foot, except (7) Drainage—indicate the amount of that additional plans for some areas slope of floors to the drains in proc- showing detail may be drawn to a scale essing rooms, coolers, toilets, and 1 ″ of ⁄4 per foot. The plot plan may be refuse rooms, and give description of 1 ″ drawn to a scale of not less than ⁄32 trapping and venting of drainage lines per foot. The drawings shall indicate and of floor drain openings. Indicate the scale used and shall also indicate size of drainage lines and whether the floor shown (e.g., basement, first, house drainage lines and toilet soil or second). lines are separate to a point outside of (c) Features required to be shown on buildings. floor plan. The following features shall (8) Heating—indicate type. be shown on the floor plan: (1) The principal pieces of equipment (9) Water supply—indicate whether drawn to scale in the proper locations. public or private water supply, or both, (2) The name of the firm and the ad- and specify in terms of gallons of water dress of the plant by street and street available per minute for the processing number, or by other means properly needs of the plant. Also indicate identifying the location of the plant. whether or not a nonpotable water sup- (3) One point of the compass. ply is used for any purpose in the plant (4) The doors and openings for pas- and, if so, specify such uses. sageways, designating those which are (10) Hot water facilities—specify fa- self-closing or permanently closed. cilities such as boilers, storage tanks, (5) All floor drain openings and gut- mixing valves, etc., and indicate the ter drains. size and number of boilers and storage (6) Lavatories in toilet and proc- tanks. essing rooms (lavatories which are (11) Specify number of men and num- other than hand-operated shall be so ber of women who will use each toilet designated on the drawings or blue- room. prints). (12) Sewage disposal—indicate wheth- (7) All steam and hot and cold water er city sewer, cesspool, sedimentation outlets for cleanup purposes. tank, etc. (8) Ice-making and storage facilities. (13) Approximate rate of production— (9) The point at which live rabbits indicate hourly rate of slaughter and are hung on the conveyor line, the evisceration for rabbits. point at which the ready-to-cook rab- (e) Rooms and compartments which bits are removed, and any intermediate must be included in the official plant. transfer points. The official plant shall include employ- (10) The routes of the edible and ined- ees’ toilet and dressing rooms, office ible products. space for the inspectors, storerooms for (11) The location of fresh air inlets, supplies, refuse rooms, and rooms, exhaust fans, and hoods. compartments, or passageways where (d) Specifications. Specifications cov- rabbits or any ingredients to be used in ering the following items shall accom- the preparation of products under in- pany the drawings: spection will be handled or kept. It also (1) Height of ceilings. may include other rooms or compart- (2) Type of ceilings—open or closed. ments located in the buildings com- (3) Finish of ceilings; for example— prising the official plant. cement plaster, metal, marine ply- (f) Changes in drawings or blueprints. wood, cement, asbestos board, etc. When changes are proposed in areas for (4) Finish of walls; for example—ce- which drawings or blueprints have been ment plaster, glazed tile, glaze brick, previously approved, one of the fol- glass blocks, etc. lowing types of revised drawings or (5) Screens—indicate whether all out- blueprints shall be submitted for re- side openings are screened or provided view and consideration.

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(1) A completely revised sheet or tempt on the part of a person currently sheets showing proposed alterations or denied the benefits of the Act to obtain additions, or inspection service; (2) Approved pasters of the proposed (e) Whenever the applicant, after an changes which may be affixed to the af- initial survey has been made in accord- fected areas on the previously approved ance with § 354.34(a), fails to bring the drawings or blueprints in a manner not plant, facilities, and operating proce- obscuring essential data. Paster draw- dures into compliance with the regula- ings and blueprints shall be prepared to tions within a reasonable period of the same scale and presented on a time; or background similar to that of the (f) Notwithstanding any prior ap- originally approved drawing or blue- proval whenever, before inauguration print. of service, the applicant fails to fulfill (g) Final survey and plant approval. commitments concerning the inau- Prior to the inauguration of the inspec- guration of the service. Each such ap- tion service, a final survey of the plant plicant shall be promptly notified by and premises shall be made by the area registered mail of the reasons for the supervisor or his assistant to deter- rejection. A written petition for recon- mine if the plant is constructed and fa- sideration of such rejection may be cilities are installed in accordance filed by the applicant with the Admin- with the approved drawings and the istrator if postmarked or delivered regulations in this part. The plant may within 10 days after the receipt of no- be approved by the Administrator only tice of the rejection. Such petition when these requirements have been shall state specifically the errors al- met, except that conditional approval leged to have been made by the Admin- for a specified limited time may be istrator in rejecting the application. granted only under emergency condi- Within 20 days following the receipt of tions of restricted availability of facili- such a petition for reconsideration, the ties and construction materials, pro- Administrator shall approve the appli- vided practices suitable to the Admin- cation or notify the applicant by reg- istrator are employed to effect ade- istered mail of the reasons for the re- quate sanitary conditions in the plant. jection thereof. (Approved by the Office of Management and Budget under control number 0583–0036) § 354.36 Withdrawal of application. [41 FR 23702, June 11, 1976, as amended at 47 Any application for inspection serv- FR 746, Jan. 7, 1982] ice may be withdrawn by the applicant at any time before the service is per- § 354.35 Rejection of application. formed upon payment, by the appli- Any application for inspection serv- cant, of all expenses incurred by the ice may be rejected by the Adminis- Service in connection with such appli- trator: cation. (a) Whenever the applicant fails to meet the requirements of the regula- § 354.38 Suspension of plant approval. tions prescribing the conditions under (a) Any plant approval given pursu- which the service is made available; ant to the regulations in this part may (b) Whenever the product is owned by be suspended by the Administrator for: or located on the premises of a person (1) Failure to maintain plant and currently denied the benefits of the equipment in a satisfactory state of re- Act; pair; (c) Where any individual holding of- (2) The use of operating procedures fice or a responsible position with or which are not in accordance with the having a substantial financial interest regulations in this part; or or share in the applicant is currently (3) Alterations of buildings, facilities, denied the benefits of the Act or was or equipment which cannot be ap- responsible in whole or in part for the proved in accordance with the regula- current denial of the benefits of the tions in this part. Act to any person; (b) During such period of suspension, (d) Where the Administrator deter- inspection service shall not be ren- mines that the application is an at- dered. However, the other provisions of

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the regulations pertaining to providing Such petition shall state specifically service on a resident basis will remain the errors alleged to have been made in effect unless such service is termi- by the Administrator in denying the nated in accordance with the provi- benefits of the Act pending investiga- sions of this part. If the plant facilities tion and hearing. Within 20 days fol- or methods of operation are not lowing the receipt of such petition for brought into compliance within a rea- reconsideration, the Administrator sonable period of time, to be specified shall reinstate the benefits of the Act by the Administrator, the service shall or notify the petitioner of the reasons be terminated. Upon termination of infor continued interim denial. spection service in an official plant [41 FR 23702, June 11, 1976, as amended at 43 pursuant to the regulations in this FR 11148, Mar. 17, 1978] part, the plant approval shall also become terminated, and all labels, seals, § 354.46 Misrepresentation; deceptive tags or packaging material bearing of- or fraudulent acts or practices. ficial identification shall, under the su- Any willful misrepresentation or any pervision of a person designated by the deceptive or fraudulent act or practice Service, either be destroyed, or the of- made or committed by any person in ficial identification completely obliter- connection with: ated, or sealed in a manner acceptable (a) The making or filing of any appli- to the Service. cation for any inspection service; (b) The making of the product acces- VIOLATIONS sible for inspection; (c) The making, issuing, or using, or § 354.45 Denial of service. attempting to issue or use any inspec- (a) The acts or practices set forth in tion certificate, symbol, stamp, label, §§ 354.46 through 354.51 or the causing seal or identification, authorized pur- thereof may be deemed sufficient suant to the regulations in this part; cause, for the debarment, by the Sec- (d) The use of the terms ‘‘U.S. In- retary, of any person, including any spected’’ or ‘‘Government Inspected’’, agents, officers, subsidiaries, or affili- or any term of similar import in the la- ates of such person, from any or all beling or advertising of any product. benefits of the Act for a specified period after notice and opportunity for § 354.47 Use of facsimile forms. hearing has been afforded. Using or attempting to use a form (b) Whenever the Administrator has which simulates, in whole or in part, reason to believe that any person or his any certificate, symbol, stamp, label, employee, agent, or representative has seal or identification authorized to be flagrantly or repeatedly committed issued or used under the regulations in any of the acts or practices specified in this part. §§ 354.46 to 354.51, he may, without hearing, direct that the benefits of the Act § 354.48 Willful violation of the regula- be denied such person, including any tions. agents, officers, subsidiaries, or affili- Any willful violation of the regula- ates of such person, pending investigations in this part or the Act. tion and hearing, and shall give notice thereof to any such person in the man- § 354.49 Interfering with an inspector ner prescribed in § 1.147(b) of the rules or employee of Service. of practice (7 CFR 1.147(b)). The Admin- Any interference with or obstruction istrator’s decision to deny the benefits or any attempted interference or ob- of the Act to any such person, includ- struction of or assault upon any in- ing any agents, officers, subsidiaries, spector or employee of the Service in or affiliates of such person, shall be ef- the performance of his duties. The giv- fective upon service of such notice. A ing or offering directly or indirectly of written petition for reconsideration of any money, loan, gift, or anything of such interim denial may be filed with value to an employee of the Service or the Administrator by any person so de- the making or offering of any contribu- nied the benefits of the Act within 10 tion to or in any way supplementing days after notice of the interim denial. the salary, compensation, or expenses

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of an employee of the Service, or the ameter of the inspection mark used on offering or entering into a private con- labels for inspected products shall be tract or agreement with an employee equal to at least one-tenth of the of the Service for any services to be length of the label, plus at least one- rendered while employed by the Serv- tenth of the width of the label. If the ice. labeling is printed or otherwise applied directly to the container, the principal § 354.51 Miscellaneous. display panel of such container shall, The existence of any of the condi- for this purpose, be considered as the tions set forth in § 354.35 constituting a label. basis for the rejection of an application for inspection service. § 354.62 Inspection mark with respect to product. OTHER APPLICABLE REGULATIONS The Administrator is authorized to prescribe and approve the form of the § 354.53 Other applicable regulations. inspection mark that may be used. Compliance with the regulations in this part shall not excuse failure to § 354.63 Marking inspected products. comply with any other Federal or any (a) Wording and form of inspection State or municipal applicable laws or mark. Except as otherwise authorized, regulations. the inspection mark permitted to be used with respect to inspected and cer- IDENTIFYING AND MARKING PRODUCTS tified edible products shall include wording as follows: ‘‘Inspected for § 354.60 Approval of official identifica- Wholesomeness by U.S. Department of tion. Agriculture.’’ This wording shall be (a) Any label or packaging material contained within a circle in the form which bears any official identification and arrangement shown in § 354.65. The shall be used only in such manner as appropriate plant number of the offi- the Administrator may prescribe. No cial plant shall be included in the cir- label or packaging material bearing of- cle unless it appears elsewhere on the ficial identification may be used unless packaging material. The Adminis- finished copies or samples of such la- trator may approve the use of abbre- bels and packaging material have been viations of such inspection mark, and approved by the Administrator. No such approved abbreviations shall have label bearing official identification the same force and effect as the inspec- shall be printed for use until the print- tion mark. The inspection mark or ap- er’s final proof has been approved by proved abbreviation thereof, as the the Administrator, and no label, other case may be, may be applied to the in- than labels for shipping containers or spected and certified edible product or containers for institutional packs, to the packaging material of such prod- bearing any official identification shall uct. When the inspection mark, or the be used until finished copies or samples approved abbreviation thereof, is used of such labels have been approved by on packaging material, it shall be the Administrator. Final approval may printed on such material or on a label be given to printer’s final proof or pho- to be affixed to the packaging material tostatic copies of labels for shipping and the name of the packer or dis- containers or containers for institu- tributor of such product shall be print- tional packs, and no such labels shall ed on the packaging material or label, be used until such proofs or copies have as the case may be, except that on been approved by the Administrator. A shipping containers and containers for label which bears official identification institutional packs, the inspection shall not bear any statement that is marks may be stenciled on the con- false or misleading, and if labels in the tainer and, when the inspection mark name of the same packer or dis- is so stenciled, the name and address of tributor, or bearing the same brand the packer or distributor may be ap- name, are used on the same or similar plied by the use of a stencil or a rubber products which are prepared from prod- stamp. Notwithstanding the foregoing, ucts which are not inspected, the di- the name and address of the packer or

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distributor, if appropriately shown lete, accompanied with a statement elsewhere on the packaging material, that such approvals are no longer de- may be omitted from insert labels sired. The approvals shall be identified which bear an official identification if by the date of approval and the name the applicable plant number is shown. of product or other designation show- (b) Wording on labels. Each trade label ing the class of material. to be approved for use pursuant to §§ 354.60 to 354.64 with respect to any in- § 354.64 Form of official identification. spected and certified edible product The form prescribed in § 354.65 is sub- shall bear the true name of the edible ject to the requirements of §§ 354.60 to product, the name and address of the packer or distributor thereof, and in 354.64, Identifying and Marking Prod- prominent letters and figures of uni- ucts. form size, the inspection mark, as aforesaid, and the label shall also bear, § 354.65 Form of inspection mark. in such manner as may be prescribed or The inspection mark approved for use approved by the Administrator, the on inspected and certified edible prod- plant number, if any, of the official ucts shall be contained within a circle plant in which such product was in- and include the following wording: spected and certified. The class of the ‘‘Inspected for Wholesomeness by U.S. rabbits shall be shown on the label. Department of Agriculture.’’ The form The appropriate designation ‘‘young’’, and arrangement of such wording shall ‘‘mature’’, or ‘‘old’’ may be used as a be as indicated in the example below. prefix to the word ‘‘rabbit’’ in lieu of The plant number of the official plant the class name. shall be set forth if it does not appear (c) Labels in foreign languages. Any on the packaging material. trade label to be affixed to a container of any edible products for foreign commerce may be printed in a foreign language. However, the inspection mark shall appear on the label in English, but, in addition, may be literally translated into such foreign language. Each such trade label which is to be printed in a foreign language must be approved pursuant to §§ 354.60 to 354.64. (d) Unauthorized use or disposition of approved labels. (1) Labels approved for use pursuant to §§ 354.60 to 354.64 shall be used only for the purpose for which approved and shall not otherwise be disposed of from the plant for which approved except with written approval of the Administrator. Any unauthorized use or disposition of approved la- SUPERVISION OF MARKING AND bels or labels bearing official identi- PACKAGING fication may result in cancellation of the approval and denial of the use of la- § 354.70 Evidence of label approval. bels bearing official identification or denial of the benefits of the Act pursu- No inspector shall authorize the use ant to the provisions of § 354.60. of official identification for any in- (2) The use of simulations or imita- spected product unless he has on file tions of any official identification by evidence that such official identifica- any person is prohibited. tion or packaging material bearing (e) Rescindment of approved labels. such official identification has been ap- Once a year, or more often if requested, proved in accordance with the provi- each applicant shall submit to the Ad- sions of §§ 354.60 to 354.64. ministrator a list in triplicate of approved labels that have become obso-

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§ 354.71 Affixing of official identifica- this part and under such conditions and tion. in accordance with such methods as (a) No official identification or any may be prescribed or approved by the abbreviation, copy, or representation Administrator. thereof may be affixed to or placed on § 354.75 Accessibility of products. or caused to be affixed to or placed on any product or container thereof ex- Each product for which inspection cept by an inspector or under the su- service is requested shall be so ar- pervision of an inspector. All such ranged so as to permit adequate deter- products shall have been inspected and mination of its class, quantity, and certified. The inspector shall have su- condition as the circumstances may pervision over the use and handling of warrant. all material bearing any official identification. § 354.76 Time of inspection in an official plant. (b) Each container of inspected and certified products to be shipped from The inspector who is to perform the one official plant to another official inspection in an official plant shall be plant for further processing shall be informed, in advance, by the applicant marked for identification and shall of the hours when such inspection is show the following information: desired. Inspectors shall have access at (1) The name of the inspected and all times to every part of any official certified products in the container; plant to which they are assigned. (2) The name and address of the packer or distributor of such products; REPORTS (3) The net weight of the container; § 354.90 Report of inspection work. (4) The inspection mark permitted to be used pursuant to the regulations in Reports of the work of inspection this part unless the containers are carried on within official plants shall sealed or otherwise identified in such be forwarded to the Administrator by manner as may be approved by the Ad- the inspector in such manner as may ministrator; and be specified by the Administrator. (5) The plant number of the official § 354.91 Information to be furnished to plant where the products were packed. inspectors. § 354.72 Packaging. When inspection service is performed No container which bears or may within an official plant, the applicant bear any official identification or any for such inspection shall furnish to the abbreviation or copy or representation inspector rendering such service such thereof may be filled in whole or in information as may be required for the part except with edible products which purposes of §§ 354.90 to 354.92. were inspected and certified and are, at (Approved by the Office of Management and the time of such filing, sound, whole- Budget under control number 0583–0036) some, and fit for human food. All such [41 FR 23702, June 11, 1976, as amended at 47 filling of containers shall be under the FR 746, Jan. 7, 1982] supervision of an inspector. § 354.92 Reports of violation. § 354.73 Retention labels. Each inspector shall report, in the An inspector may use such labels, de- manner prescribed by the Adminis- vices, and methods as may be approved trator, all violations of and noncompli- by the Administrator for the identi- ance with the Act and the regulations fication of: in this part of which he has knowledge. (a) Products which are held for further examination, and FEES AND CHARGES (b) All equipment and utensils which are to be held for proper cleaning. § 354.100 Payment of fees and charges. (a) Fees and charges for any inspec- § 354.74 Prerequisites to inspection. tion shall be paid by the applicant for Inspection of products shall be ren- the service in accordance with the ap- dered pursuant to the regulations in plicable provisions of §§ 354.100 to

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354.110, both inclusive. If so required by § 354.107 Continuous inspection per- the inspector, such fees and charges formed on a resident basis. shall be paid in advance. The charges for inspection of rabbits (b) Fees and charges for any inspec- and products thereof shall be those pro- tion service shall, unless otherwise re- vided for in § 354.101(b) and specified by quired pursuant to paragraph (c) of this hourly rates in §§ 391.2 and 391.3 when section, be paid by check, draft, or the inspection service is performed on money order payable to the Food Safe- a continuous year-round resident basis ty and Inspection Service and remitted and the services of an inspector or in- promptly to the Service. spectors are required 4 or more hours (c) Fees and charges for any inspec- per day. When the services of an in- tion pursuant to a cooperative agree- spector are required on an intermittent ment with any State or person shall be basis, the charges shall be those pro- paid in accordance with the terms of vided for in § 354.101(b) and specified by such cooperative agreement. hourly rates in §§ 391.2 and 391.3 plus the travel expense and other charges § 354.101 On a fee basis. provided for in § 354.106. (a) Unless otherwise provided in this [54 FR 6390, Feb. 10, 1989] part, the fees to be charged and collected for any service performed, in ac- § 354.109 Fees or charges for inspec- cordance with this part, on a fee basis tion service performed under coop- shall be based on the applicable rates erative agreement. specified in this section. Fees or charges to be made to an ap- (b) The charges for inspection service plicant for any inspection service will be based on the time required to which differ from those listed in perform such services. The hourly rates §§ 354.100 through 354.107 shall be pro- shall be as specified in §§ 391.2 and 391.3 vided for by a cooperative agreement. respectively for base time and for overtime or holiday work. § 354.110 Disposition of fees for inspec- (c) Charges for certain laboratory tion made under cooperative agreement. analysis or laboratory examination of rabbits under this part related to in- Fees for inspection under a coopera- spection service shall be at the rate tive agreement with any State or per- specified in § 391.4 for that part which is son shall be disposed of in accordance not covered under the base time, over- with the terms of such agreement. time, and/or holiday costs. Such portion of the fees collected under a cooperative agreement as may [41 FR 23702, June 11, 1976, as amended at 53 be due the United States shall be re- FR 13398, Apr. 22, 1988; 54 FR 6390, Feb. 10, mitted to the Service. 1989] INSPECTION PROCEDURES; ANTE-MORTEM § 354.105 Fees for additional copies of INSPECTIONS inspection certificates. Additional copies, other than those § 354.120 Manner of handling products provided for in §§ 354.141, 354.142, and in an official plant. 354.143, of any inspection certificates Unless otherwise specified in the reg- may be supplied to any interested ulations in this part or by the Adminis- party upon payment of a fee of $2.00 for trator, products which are to be fur- each set of five or fewer copies. ther processed under inspection in an official plant shall be prepared and § 354.106 Travel expenses and other handled in such official plant under the charges. supervision of an inspector. Charges are to be made to cover the cost of travel and other expenses in- § 354.121 Ante-mortem inspection. curred by the Service in connection An ante-mortem inspection of rabbits with rendering inspection service. Such shall, where and to the extent consid- charges shall include the costs of ered necessary by the Administrator transportation, per diem, and any and under such instructions as he may other expenses. issue from time to time, be made of

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rabbits on the day of slaughter in any of such rabbits shall be deferred and official plant processing rabbits under they shall be dealt with in one of the inspection pursuant to the regulations following ways: in this part. (a) If it is determined by a veterinary inspector that further handling of the § 354.122 Condemnation on ante- rabbits will not create a health hazard, mortem inspection. the lot shall be subject to ante-mortem Rabbits found in a dying condition on and post-mortem inspection pursuant premises of an official plant shall be to the regulations in this part. immediately destroyed and, together (b) If it is determined by a veterinary with any rabbits found dead on such inspector that further handling of the premises, shall be disposed of in ac- rabbits will not create a health hazard, cordance with § 354.132. Rabbits plainly such rabbits may be released for treat- showing, on ante-mortem inspection, ment under the control of an appro- any disease or condition, that under priate State or Federal agency. If the §§ 354.129 to 354.131, inclusive, would circumstances are such that release for cause condemnation of their carcasses treatment is impracticable, a careful on post-mortem inspection, shall be rabbit-by-rabbit ante-mortem inspec- condemned. Rabbits which, on ante- tion shall be made, and all rabbits mortem inspection, are condemned found to be, or which are suspected of shall not be dressed, nor shall they be being, affected with the contagious dis- conveyed into any department of the ease transmissible to man shall be con- plant where rabbit products are pre- demned. pared or held. Rabbits which have been condemned on ante-mortem inspection POST-MORTEM INSPECTION and have been killed shall, under the supervision of an inspector of the In- § 354.125 Evisceration. spection Service, receive treatment as No viscera or any part thereof shall provided in § 354.132. be removed from any rabbits which are to be processed under inspection in any § 354.123 Segregation of suspects on official plant, except at the time of ante-mortem inspection. evisceration and inspection. Each car- All rabbits which, on ante-mortem cass to be eviscerated shall be opened inspection, do not plainly show, but are so as to expose the organs and the body suspected of being affected with any cavity for proper examination by the disease or condition that under inspector and shall be prepared imme- §§ 354.129 to 354.131, inclusive, may diately after inspection as ready-to- cause condemnation in whole or in part cook rabbit. on post-mortem inspection, shall be segregated from the other rabbits and § 354.126 Carcasses held for further ex- held for separate slaughter, eviscera- amination. tion, and post-mortem inspection. The Each carcass, including all parts inspector shall be notified when such thereof, in which there is any lesion of segregated lots are presented for post- disease or other condition, which mortem inspection and inspection of might render such carcass or any part such rabbits shall be conducted sepa- thereof unfit for human food, and with rately. Such procedure for the correla- respect to which a final decision can- tion of ante-mortem and post-mortem not be made on first examination by findings by the inspector, as may be the inspector, shall be held for further prescribed or approved by the Adminis- examination. The identity of each such trator, shall be carried out. carcass, including all parts thereof, shall be maintained until a final exam- § 354.124 Quarantine of diseased rab- ination has been completed. bits. If live rabbits, which are affected by § 354.127 Condemnation and treatment any contagious disease which is trans- of carcasses. missible to man, are brought into an Each carcass, or any part thereof, official establishment, such rabbits which is found to be unsound, unwhole- shall be segregated. The slaughtering some, or otherwise unfit for human

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food shall be condemned by the inspec- (b) Any organ or part of a rabbit car- tor and shall receive such treatment, cass affected with a tumor shall be con- under the supervision of the inspector, demned and when there is evidence as will prevent its use for human food that the general condition of the rabbit and preclude dissemination of disease has been affected by the size, position, through consumption by animals. or nature of the tumor, the whole carcass shall be condemned. In cases of § 354.128 Certification of carcasses. malignant neoplasms involving any in- Each carcass and all parts and organs ternal organ to a marked extent, or af- thereof which are found by the inspec- fecting the muscles, skeleton, or body tor to be sound, wholesome, and fit for lymph glands, even primarily, the human food shall be certified as pro- whole carcass shall be condemned. vided in this part. (c) Carcasses of rabbits showing any disease such as generalized melanosis, DISPOSITION OF DISEASED RABBIT pseudoleukemia, and the like, which CARCASSES AND PARTS systemically affect the rabbit, shall be condemned. § 354.129 General. (d) Any organ or part of a carcass The carcasses or parts of carcasses of which is badly bruised or which is af- all rabbits inspected at an official es- fected by an abscess, or a suppurating tablishment and found at the time of sore, shall be condemned. Parts or car- post-mortem inspection, or at any sub- casses which are contaminated by pus sequent inspection, to be affected with shall be condemned. any of the diseases or conditions (e) Carcasses of rabbits contaminated named in other sections in this part, by volatile oils, paints, poisons, gases, shall be disposed of in accordance with or other substances which affect the the section pertaining to the disease or wholesomeness of the carcass shall be condition. Owing to the fact that it is condemned. impracticable to formulate rules for (f) All carcasses of rabbits so infected each specific disease or condition and that consumption of the meat or meat to designate at just what stage a dis- food products thereof may give rise to ease process results in an unwholesome meat poisoning shall be condemned. product, the decision as to the disposal This includes all carcasses showing of all carcasses, parts, or organs not signs of any of the following diseases: specifically covered by the regulations, Acute inflammation of the lungs, pleu- or by instructions of the Administrator ra, pericardium, peritoneum or issued pursuant thereto, shall be left to meninges; septicemia or pyemia, the inspector in charge, and if the in- whether traumatic, or without evident spector in charge is in doubt con- cause; gangrenous or severe hemor- cerning the disposition to be made, rhagic enteritis or gastritis; specimens from such carcasses shall be polyarthritis and acute nephritis. Im- forwarded to the laboratory for diag- mediately after the slaughter of any nosis. rabbit so infected, the infected premises and implements used shall be thor- § 354.130 Diseases or conditions evi- oughly sanitized. The part or parts of dent which require condemnation. any carcass coming into contact with (a) Carcasses of rabbits affected with the carcass or any part of the carcass or showing lesions of any of the fol- of any rabbit covered by this section lowing named diseases or conditions other than those affected with acute shall be condemned: Tularemia, an- inflammation of the lungs, pleura, per- thrax, hemorrhagic septicemia, icardium, peritoneum or meninges, pyemia, septicemia, leukemia, acute shall be condemned. enteritis, peritonitis, sarcomatosis, (g) Carcasses showing any degree of metritis, necrobacillosis (Smorl’s Dis- icterus with a parenchymatous degen- ease), tuberculosis, emaciation, eration of organs, the result of infec- streptobacillary pseudotuberculosis, tion or intoxication, and those which, and advanced stages of snuffles. Rab- as a result of a pathological condition, bits from pathological laboratories show an intense yellow or greenish-yel- shall be condemned. low discoloration without evidence of

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infection or intoxication shall be con- (b) [Reserved] demned. (c) Carcasses affected by types of (h) Carcasses of rabbits affected with post-mortem change which are super- mange or scab in advanced stages, or ficial in nature may be certified for showing emaciation or extension of the food after removal and condemnation inflammation to the flesh, shall be con- of affected parts. demned. When the diseased condition is slight, the carcass may be passed for § 354.132 Disposal of condemned car- food after removal and condemnation casses and parts. of the affected parts. All condemned carcasses, or parts of (i) In the disposal of carcasses and parts of carcasses showing evidence of carcasses, shall be disposed of by one of infestation with parasites not trans- the following methods, under the su- missible to man, the following general pervision of an inspector of the Inspec- rules shall govern: If the lesions are lo- tion Service: (Facilities and materials calized in such manner and are of such for carrying out the requirements in character that the parasites and the le- this section shall be furnished by the sions caused by them may be radically official establishment.) removed, the non-affected portion of (a) Steam treatment (which shall be the carcass, or part of the carcass, may accomplished by processing the con- be certified for food after the removal demned product in a pressure tank and condemnation of the affected por- under at least 40 pounds of steam pres- tions. Where a part of a carcass shows sure) or thorough cooking in a kettle numerous lesions caused by parasites, or vat for a sufficient time to effec- or the character of the infestation is tively destroy the product for human such that complete extirpation of the food purposes and preclude dissemina- parasites and lesions is difficult and tion of disease through consumption by uncertainly accomplished, or if the animals. Tanks and equipment used for parasitic infestation or invasion ren- this purpose or for rendering or pre- ders the organ or part in any way unfit paring inedible products shall be in for food, the affected organ or part rooms or compartments separate from shall be condemned. Where parasites those used for the preparation of edible are found to be distributed in a carcass products. There shall be no direct con- in such a manner or to be of such a character that their removal and the nection, by means of pipes or other- removal of the lesions caused by them wise, between tanks containing ined- are impracticable, no part of the car- ible products and those containing edi- cass shall be certified for food and the ble products. entire carcass shall be condemned. Car- (b) Incineration or complete destruc- casses infested with a hydatid cyst or tion by burning. cysts (Echinococcus granulosis), trans- (c) Chemical denaturing, which shall missible to dogs and from dogs to man, be accomplished by the liberal applica- shall in all cases be condemned regard- tion to all carcasses and parts thereof, less of the degree of infestation. of: (j) Carcasses of rabbits showing such (1) Crude carbolic acid, degree of emaciation or anemic condi- (2) Kerosene, fuel oil, or used crank tion as would render the meat un- case oil, wholesome, and carcasses which show a (3) Any phenolic disinfectant con- slimy degeneration of the fat or a seri- forming to commercial standards CS ous infiltration of the muscles shall be 70–41 or CS 71–41 which shall be used in condemned. at least 2 percent emulsion or solution, § 354.131 Decomposition. or Carcasses of rabbits deleteriously af- (4) Any other substance that the Ad- fected by post-mortem changes shall be ministrator approves which will disposed of as follows: decharacterize the carcasses or parts to (a) Carcasses which have reached a the extent necessary to accomplish the state of putrefaction or stinking fer- purposes of this section. mentation shall be condemned.

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REINSPECTION AND INGREDIENTS immediate superior of the employee of the Department making the appeal in- § 354.133 Reinspection of edible prod- spection. The cost of any such appeal ucts; ingredients. shall be borne by the applicant if the (a) Any inspected and certified edible Administrator determines that the ap- product may be brought into an official peal is frivolous. The charges for such plant only if the container of such frivolous appeal shall be based on the product is marked for identification in hourly rates as specified in § 354.101(b). the manner prescribed in § 354.71(b) and the product is reinspected by an inspec- INSPECTION CERTIFICATES tor at the time it is brought into such plant. Upon reinspection, if any such § 354.140 Forms of inspection certificates. product or portion thereof is found to be unsound, unwholesome, or otherwise Each inspection certificate issued unfit for human food, such product, or pursuant to the regulations in this part portion thereof, shall be condemned shall be approved by the Administrator and shall receive treatment as provided as to form, and: in § 354.127. (a) Each rabbit inspection certificate (b) Any product which is prepared shall show the class or classes of rab- under inspection in an official plant bits, the quantity of product contained shall be inspected in such plant as in the respective lot, and all pertinent often as the inspector deems it nec- information concerning the condition essary in order to ascertain whether and wholesomeness thereof; such product is sound, wholesome, and (b) Each food product inspection cer- fit for human food at the time such tificate shall show the names of the ed- product leaves such plant. Upon any ible products covered by such certifi- such inspection, if any such product or cate, the quantity of each such prod- portion thereof is found to be unsound, uct, such shipping marks as are nec- unwholesome, or otherwise unfit for essary to identify such products, and human food, such product or portion all pertinent information concerning thereof shall be condemned and shall the condition and wholesomeness receive treatment as provided in thereof; § 354.127. (c) Each export certificate shall show (c) All substances and ingredients the respective names of the exporter used in the manufacture or preparation and the consignee, the destination, the of any edible product shall be clean, shipping marks, the numbers of the ex- sound, wholesome, and fit for human port stamps attached to the edible food. Liquid and frozen egg products products to be exported and covered by used in the preparation of any edible the certificate, and the names of such product shall have been prepared under products and the total net weight continuous inspection of the Depart- thereof. ment. § 354.141 Issuance and disposition of APPEALS rabbits inspection certificates. (a) Upon the request of an interested § 354.134 Appeal inspections; how party, any inspector is authorized to made. issue a rabbit inspection certificate Any person receiving inspection serv- with respect to any lot of rabbits in- ice may, if dissatisfied with any deci- spected by him. Each certificate shall sion of an inspector relating to any in- be signed by the inspector who made spection, file an appeal from such deci- the inspection covered by the certifi- sion: Provided, That such appeal is filed cate, and if more than one inspector within 48 hours from the time the deci- participated in the inspection of the lot sion was made. Any such appeal from a of rabbits, each such inspector shall decision of an inspector shall be made sign the certificate with respect to to his immediate superior having juris- such lot. diction over the subject matter of the (b) The original and a copy of each appeal. Review of such appeal findings, inspection certificate, issued pursuant when requested, shall be made by the to §§ 354.140 to 354.144, and not to exceed

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two additional copies thereof if re- the area in which such export certifi- quested by the applicant prior to cate was issued, and the memorandum issuance, shall, immediately upon copy shall be retained by the inspector issuance, be delivered or mailed to the for filing. The last named three copies applicant or person designated by him. shall be retained until otherwise or- One copy shall be filed in the office of dered by the Administrator. the area supervisor serving the area in which the inspection was performed, § 354.144 Advance information. and the remaining copies shall be dis- Upon the request of an applicant, all posed of in such manner as the Admin- or part of the contents of any inspec- istrator may approve. Additional cop- tion certificate issued to such appli- ies of any such certificate may be fur- cant may be telephoned or telegraphed nished to any interested party as pro- to him, or to any person designated by vided in § 354.105. him, at his expense.

§ 354.142 Food product inspection cer- BASIS OF ACCEPTABILITY OF OTHER tificates; issuance and disposition. OFFICIAL INSPECTION SYSTEMS (a) Upon the request of an interested party, any inspector is authorized to § 354.160 General. issue a food product inspection certifi- Any rabbit inspection system may be cate with respect to any inspected and deemed to be acceptable to the Admin- certified edible product after suitable istrator which: examination of the product has been (a) Is conducted under the authority made by the inspector. of laws, ordinances, or similar enact- (b) The original of each food product ments of the State, county, city, or inspection certificate, and not to ex- other political subdivision in which is ceed two copies thereof, if requested, located the official plant at which the shall, immediately upon issuance, be ready-to-cook rabbits are prepared and delivered or mailed to the applicant or person designated by him. Another (b) Imposes at least the requirements copy shall be filed in the office of the set forth in § 354.161: Provided, That no regional supervisor serving the area in such inspection shall be deemed ac- which such certificate was issued, and ceptable to the Administrator with re- one copy shall be forwarded to the Ad- spect to any official plant in which ministrator. The last named two copies ready-to-cook rabbits are prepared if shall be retained until otherwise or- he finds at any time that such require- dered by the Administrator. ments are not adequately enforced.

§ 354.143 Export certificates; issuance § 354.161 Requirements as to manner and disposition. of inspection. (a) Upon the request of an exporter, (a) The inspection shall be conducted any inspector is authorized to issue an by an inspector who is a qualified vet- export certificate with respect to the erinarian or under the supervision of a shipment to any foreign country of any qualified veterinarian. All such inspec- inspected and certified edible product tors shall be employed by the State, after suitable examination of the prod- county, city, or other political subdivi- uct has been made by the inspector. sion in which the official plant is lo- (b) Each export certificate shall be cated. issued in quintuplicate; the original (b) The inspection shall include post- shall be delivered to the exporter who mortem examination of each rabbit requested such certificate, and the du- carcass during the evisceration oper- plicate copy shall be delivered to the ation. agent of the railroad or other carrier (c) All carcasses which show evidence transporting such products from the of disease or any other condition which United States. The triplicate copy of may render them unwholesome or unfit such export certificate shall be for- for food shall be condemned and shall warded to the Administrator; the quad- be destroyed for food purposes under ruplicate copy shall be filed in the of- the supervision of an inspector. Each fice of the regional supervisor serving carcass and part thereof which has

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been inspected and passed or con- (2) Outside doors, except in receiving tainers of carcasses or parts thereof rooms and live rabbit holding rooms, shall bear the identifying inspection shall be self-closing and so hung that symbol of the official inspection sys- not over 1⁄4–inch clearance remains tem and the marking devices or labels when closed. Screen doors shall open shall be in the custody of the inspector toward the outside of the building. at all times. § 354.221 Rooms and compartments. § 354.162 Determining compliance with Rooms and compartments used for § 354.161. edible products shall be separate and A qualified veterinary supervisor of distinct from inedible products depart- the rabbit inspection service shall in- ments and from rooms where rabbits vestigate the manner of operation of are slaughtered and skinned. Separate the inspection system to determine the rooms shall be provided when required adequacy of the post-mortem examina- for conducting processing operations in tion and the compliance with the re- a sanitary manner, and all rooms shall quirements contained in §§ 354.160 to be of sufficient size to permit the in- 354.162 prior to approving the official stallation of the necessary equipment plant for the inspection of ready-to- for processing operations and the con- cook rabbits. This supervisor, as well duct of such operations in a sanitary as any official graders who may be sta- manner. tioned in the official plant, shall peri- (a) Rooms for separate operation. The odically observe the inspection oper- official plant should have separate ations in the official plant to deter- rooms for each of the following oper- mine that the requirements of §§ 354.160 ations depending upon the various to 354.162 are being met. types of operations conducted, but, in no case, shall the receiving or holding SANITARY REQUIREMENTS of live rabbits or killing operations be permitted in rooms in which evis- GENERAL cerating operations are performed: (1) The receiving and feeding of live § 354.210 Minimum standards for sani- rabbits. tation, facilities, and operating procedures in official plants. (2) Killing and skinning operations. (3) Eviscerating, chilling, and pack- The provisions of §§ 354.210 to 354.247 ing operations for ready-to-cook rab- shall apply with respect to inspection bits. service in all official plants. The table (4) Inedible products departments. set forth in § 354.247 indicates some of (5) Refuse room. the types of material which may be (b) Rooms for holding carcasses for fur- used in the construction of equipment, ther inspection. Rooms and compart- utensils, and facilities for use in the ments in which carcasses or parts plant. thereof are held for further inspection shall be in such number and such loca- BUILDINGS AND PLANT FACILITIES tion as the needs of the inspection in the plant may require. They shall be § 354.220 Buildings. equipped with locks and keys and the The buildings shall be of sound con- keys shall not leave the custody of the struction and kept in good repair, and inspector in charge of the plant. All shall be of such construction as to pre- such rooms and compartments shall be vent the entrance or harboring of marked conspicuously with the word vermin. ‘‘retained’’ in letters not less than 2 (a) Outside openings. (1) The doors, inches high. windows, skylights, and other outside (c) Coolers and freezers. Coolers and openings of the plant, except receiving freezers of adequate size and capacity rooms and live rabbit holding rooms, shall be provided to reduce the internal shall be protected by properly fitted temperature of ready-to-cook rabbits screens or other suitable devices prepared and otherwise handled in the against the entrance of flies and other plant to 36 °F. within 24 hours unless insects. other cooling facilities are available.

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(d) Refuse rooms. Refuse rooms shall finished and sealed to prevent collec- be entirely separate from other rooms tion of dirt or dust that might sift in the plant, and shall have tight fit- through flooring above or fall from col- ting doors and be properly ventilated. lecting surfaces on equipment or ex- (e) Storage and supply rooms. The stor- posed product. age and supply rooms shall be in good repair, kept dry, and maintained in a § 354.223 Drainage and plumbing. sanitary condition. There shall be an efficient drainage (f) Boiler room. The boiler room shall and plumbing system for the plant and be a separate room, if necessary, to premises. prevent its being a source of dirt and objectionable odors entering any room (a) Drains and gutters. All drains and where ready-to-cook rabbits are pre- gutters shall be properly installed with pared, processed, handled, and stored. approved traps and vents. The drainage (g) Inspector’s office. Furnished office and plumbing system must permit the space, including, but not being limited quick runoff of all water from plant to, light, heat, and janitor service shall buildings, and surface water around the be provided rent free in the official plant and on the premises, and all such plant for the exclusive use for official water shall be disposed of in such a purposes of the inspector and the Ad- manner as to prevent a nuisance or ministration. The room or rooms set health hazard. apart for this purpose must meet with (b) Sewage and plant wastes. (1) The the approval of the regional supervisor sewerage system shall have adequate and be conveniently located, properly slope and capacity to remove readily ventilated, and provided with lockers all waste from the various processing or cabinets suitable for the protection operations and to minimize, and if pos- and storage of supplies and with facili- sible to prevent, stoppage and sur- ties suitable for inspectors to change charging of the system. clothing. (2) Grease traps which are connected (h) Toilet rooms. Toilet rooms opening with the sewerage system shall be suit- directly into rooms where rabbit prod- ably located but not near any edible ucts are exposed shall have self-closing products department or in any area doors and shall be ventilated to the where products are unloaded from or outside of the building. loaded into vehicles. To facilitate cleaning, such traps shall have inclined § 354.222 Floors, walls, ceilings, etc. bottoms and be provided with suitable (a) Floors. All floors in rooms where covers. exposed products are prepared or han- (3) Toilet soil lines shall be separate dled shall be constructed of or finished from house drainage lines to a point with materials impervious to moisture, outside the buildings unless they are so they can be readily and thoroughly positively trapped to prevent backing cleaned. The floors in killing, ice cool- up. Drainage from toilet bowls and uri- ing, ice packing, eviscerating, cooking, nals shall not be discharged into a boning, and cannery rooms shall be grease catch basin. graded for complete runoff with no (4) All floor drains shall be equipped standing water. (b) Walls, posts, partitions, doors. All with traps, constructed so as to mini- walls, posts, partitions, and doors in mize clogging, and the plumbing shall rooms where exposed products are pre- be so installed as to prevent sewerage pared or handled shall be smooth and from backing up and from flooding the constructed of materials impervious to floor. moisture to a height of 6 feet above the (5) Floor drainage lines should be of floor to enable thorough cleaning. All metal and at least 4 inches in diameter surfaces above this height must be and open into main drains of at least 6 smooth and finished with moisture-re- inches in diameter and shall be prop- sistant material. erly vented to outside air. (c) Ceilings. Ceilings must be mois- (6) Where refrigerators are equipped ture-resistant in rooms where exposed with drains, such drains should be products are prepared or handled, and properly trapped and should discharge

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through an air gap into the sewer sys- (e) Toilet facilities shall be provided tem. All new installations, and all re- according to the following formula: placements, or refrigerators equipped with drains shall meet these require- Toilet Persons of same sex bowls re- ments. quired

§ 354.224 Water supply. 1 to 15, inclusive ...... 1 16 to 35, inclusive ...... 2 The water supply shall be ample, 36 to 55, inclusive ...... 1 3 clean, and potable with adequate facili- 56 to 80, inclusive ...... 1 4 ties for its distribution in the plant For each additional 30 persons in excess of 80 ... 1 1 and its protection against contamina- 1 Urinals may be substituted for toilet bowls but only to the tion and pollution. extent of 1⁄3 of the total number of bowls stated. (a) Hot water at a temperature not less than 180 °F. shall be available for § 354.226 Lighting and ventilation. sanitation purposes. There shall be ample light, either (b) Hose connections with steam and natural or artificial or both, of good water mixing valves or hot water hose quality and well distributed, and suffi- connections shall be provided at con- cient ventilation for all rooms and venient locations throughout the plant compartments to insure sanitary con- for cleaning purposes. ditions. (c) The refuse rooms shall be pro- (a) All rooms in which rabbits are vided with adequate facilities for wash- killed, eviscerated, or otherwise proc- ing refuse cans and other equipment in essed shall have at least 30 foot candles the rooms; the rooms, cans, and equip- of light intensity on all working sur- ment shall be cleaned after each day’s faces except that at the inspection sta- use. tions such light intensity shall be of 50 foot candles. In all other rooms, there § 354.225 Lavatory accommodations. shall be provided at least 5 foot candles Modern lavatory accommodations of light intensity when measured at and properly located facilities for distance of 30 inches from the floor. cleaning utensils and hands shall be (b) All rooms shall be adequately provided. ventilated to eliminate objectionable (a) Adequate lavatory and toilet ac- odors and minimize moisture condensa- commodations, including, but not tion. being limited to, running hot water and cold water, soap, and towels, shall EQUIPMENT AND UTENSILS be provided. Such accommodations shall be in or near toilet and locker § 354.230 Equipment and utensils. rooms and also at such other places in Equipment and utensils used for the the plant as may be essential to the preparation, processing, or other han- cleanliness of all personnel handling dling of any product in the plant shall products. be suitable for the purpose intended (b) Sufficient metal containers shall and shall be of such material and con- be provided for used towels and other struction as will facilitate their thor- wastes. ough cleaning and insure cleanliness in (c) An adequate number of hand the preparation and handling of prod- washing facilities serving areas where dressed rabbits and edible products are ucts. prepared shall be operated by other (a) Live rabbit holding pens shall be than hand-operated controls, or shall so constructed as to allow satisfactory be of a continuous flow type which pro- ante-mortem examination and to per- vides an adequate flow of water for mit proper cleaning. washing hands. (b) Metal refuse containers shall be (d) Durable signs shall be posted con- provided, and such containers shall be spicuously in each toilet room and kept covered. locker room directing employees to (c) Insofar as it is practical, equip- wash their hands before returning to ment and utensils shall be made of work. metal or other impervious material.

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Trucks and receptacles used for han- waste resulting from preparation of dling inedible products shall be of simi- ready-to-cook rabbits. lar construction and shall be conspicu- (l) Watertight trucks and receptacles ously and distinctly marked and shall for holding or handling diseased car- not be used for handling any edible casses and diseased parts of carcasses products. shall be so constructed as to be readily (d) Chilling vats or tanks used for and thoroughly cleaned; such trucks chilling ready-to-cook rabbits shall be and receptacles shall be marked in a made of metal or other hard-surfaced conspicuous manner with the word impervious material. ‘‘condemned’’ in letters not less than 2 (e) Where grading bins are used for inches high and, when required by the ready-to-cook rabbits, they shall be of inspector in charge, shall be equipped sufficient number and capacity to han- with facilities for locking and sealing. dle the grading adequately without the (m) Freezing rooms should be ade- use of makeshift bins and all ready-to- quately equipped to freeze ready-to- cook rabbits shall be kept off the floor. cook rabbits solid in less than 48 hours. Grading bins may be made of metal or Ready-to-cook rabbits should be frozen enameled wood and shall be con- at temperatures of ¥10 °F. to ¥40 °F. structed and maintained in such a and should be stored at 0 °F. or below, manner as to allow easy and thorough with the temperature maintained as cleaning. All replacements of such bins constant as possible. Freezing room shall, however, be of metal. should be equipped with floor racks or (f) Except as otherwise provided here- pallets and fans to insure air circula- in, all equipment and utensils used in tion. the killing, skinning, eviscerating, (n) Cooling racks should be made of chilling, and packing rooms shall be of metal and be readily accessible for metal or other impervious material thorough washing and cleaning. All re- and constructed so as to permit proper placements of cooling racks shall be and complete cleaning. made of metal. (g) Conveyors: (1) Conveyors used in (o) Trucks and receptacles in which the preparation of ready-to-cook rab- carcasses or parts thereof are held for bits shall be of metal or other accept- further inspection shall be in such able material and of such construction number and such location as the needs as to permit thorough and ready clean- of the inspection in the plant may re- ing and easy identification of viscera quire. They shall be equipped for lock- with its carcass. ing by means of lock and key and the (2) Overhead conveyors shall be so key shall not leave the custody of the constructed and maintained that they inspector in charge of the plant. Such do not allow grease, oil, or dirt to accu- trucks and receptacles shall be marked mulate on the drop chain or shackle, conspicuously with the word ‘‘re- which shall be of noncorrosive metal. tained’’ in letters not less than 2 inches (3) Nonmetallic belt-type conveyors high. used in moving edible products shall be of water-proof composition. § 354.231 Accessibility. (h) Inspection, eviscerating, and cut- All equipment shall be so placed as to ting tables shall be made of metal and be readily accessible for all processing have coved corners and be so con- and cleaning operations. structed and placed to permit thorough cleaning. § 354.232 Restrictions on use. (i) In plants where no conveyors are Equipment and utensils used in the used, each carcass shall be eviscerated official plant shall not be used outside in an individual metal tray of seamless the official plant except under such construction. conditions as may be prescribed or ap- (j) Water spray washing equipment proved by the national supervisor, and shall be used for washing carcasses in- equipment used in the preparation of side and out. any article (including, but not being (k) Watertight metal receptacles limited to, animal food) from inedible shall be used for entrails and other material shall not be used outside of

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the inedible products department ex- (j) Cooler and freezer rooms shall be cept under such conditions as may be free from objectionable odors of any prescribed or approved by the national kind and shall be maintained in a sani- supervisor. tary condition (including, but not being limited to, the prevention of MAINTENANCE OF SANITARY CONDITIONS drippings from refrigerating coils onto AND PRECAUTIONS AGAINST CONTAMI- products). NATION OF PRODUCTS § 354.242 Cleaning of equipment and § 354.240 General. utensils. The premises shall be kept free from Equipment and utensils used for pre- refuse, waste materials, and all other paring or otherwise handling any prod- sources of objectionable odors and con- uct shall be kept clean and in a sani- ditions. tary condition and in good repair. (a) Pens shall be cleaned regularly § 354.241 Cleaning of rooms and com- and the manure removed from the partments. plant daily. Rooms, compartments, or other parts (b) All equipment and utensils used of the official plant shall be kept clean in the killing and skinning rooms shall and in sanitary condition. be thoroughly washed and cleaned after (a) All blood, offal, rabbits or parts of each day’s operation. The eviscerating, rabbits too severely damaged to be chilling, and packing room and equip- salvaged and all discarded containers ment and utensils used therein shall be and other materials shall be com- maintained in a clean and sanitary pletely disposed of daily. condition. (b) All windows, doors, and light fix- (c) Graders’ and packers’ gloves and tures in the official plant shall be kept grading bins shall be washed daily and clean. used only for grading or packing, as (c) All docks and rooms shall be kept the case may be. clean and free from debris and unused (d) All crates or pens used for trans- equipment and utensils. porting live rabbits to the plant shall (d) Live rabbit receiving docks and be cleaned regularly. receiving rooms shall be of such con- (e) Chilling vats or tanks, if prac- struction as readily to permit their ticable, shall be emptied after each thorough cleaning, and such docks and use. They shall be thoroughly cleaned rooms should be kept clean at all once daily and, after each cleaning op- times. eration, they shall be sanitized with (e) Floors in live rabbit holding such compounds or by such methods as rooms shall be cleaned with such regu- may be approved or prescribed by the larity as may be necessary to maintain Administrator. them in a sanitary condition. (f) When synchronized overhead con- (f) The killing and skinning room veyors and tray conveyors are used, shall be kept clean and free from offen- the trays shall be completely washed sive odors at all times. and sanitized after being automatically (g) The walls, floors, and all equip- emptied of inedible viscera. ment and utensils used in the killing (g) When a conveyor tray operation is and skinning room shall be thoroughly used, each carcass shall be eviscerated washed and cleaned after each day’s opin an individual metal tray of seamless eration. construction, and such trays shall be (h) The floor in the killing and skin- completely washed and sanitized after ning rooms shall be cleaned frequently each use. during killing and skinning operations (h) Tables, shelves, bins, trays, pans, and be kept reasonably free from accu- knives, and all other tools and equip- mulated blood, offal, water, and dirt. ment used in the preparation of ready- (i) All equipment in the toilet room to-cook rabbits shall be kept clean and and locker room, as well as the room sanitary at all times. Cleaned equip- itself, shall be kept clean, sanitary, ment and utensils shall be drained on and in good repair. racks and shall not be nested.

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(i) Drums, cans, tanks, vats, and to be employed in transporting the other receptacles used to hold or trans- product from the plant. port ready-to-cook rabbits shall be (j) Refuse may be moved directly to kept in a clean and sanitary condition. loading docks only for prompt removal. (k) Cleanliness and hygiene of per- § 354.243 Operations and procedures. sonnel: (1) All employees coming in Operations and procedures involving contact with exposed edible products or the preparation, storing, or handling of edible products handling equipment any product shall be strictly in accord shall wear clean garments and should with clean and sanitary methods. wear caps or hair nets, and shall keep (a) There shall be no handling or their hands clean at all times while storing of materials which create an thus engaged. objectionable condition in rooms, com- (2) Hands of employees handling edi- partments, or other places in the plant ble products or edible products han- where any product is prepared, stored, dling equipment shall be free of in- or otherwise handled. fected cuts, boils, and open sores at all times while thus engaged. (b) Blood from the killing operation (3) Every person, after each use of shall be confined to a relatively small toilet or change of garments, shall area and kept from being splashed wash his hands thoroughly before re- about the room. turning to duties that require the han- (c) In the final washing, the carcass dling of edible products or containers shall be passed through a system of therefor or edible products handling sprays providing an abundant supply of equipment. fresh clean water. (4) Neither smoking nor chewing of (d) The floors in the eviscerating tobacco shall be permitted in any room room shall be kept clean and reason- where exposed edible products are pre- ably dry during eviscerating operations pared, processed, or otherwise handled. and free of all refuse. (e) Conveyors shall be operated at § 354.244 Temperatures and cooling such speeds as will permit a sanitary and freezing procedures. eviscerating operation and will permit Temperatures and procedures which adequate inspection for condition and are necessary for cooling and freezing wholesomeness. of rabbits in accordance with sound (f) Mechanized packaging equipment commercial practice shall be main- shall be maintained in good sanitary tained in the coolers and freezers, and condition. chilling temperatures and procedures (g) All offal resulting from the evis- shall also be in accordance with sound cerating operation shall be removed as commercial practice. often as necessary to prevent the devel- (a) Cooling. Immediately after evis- opment of a nuisance. ceration and washing of the carcass, it (h) Paper and other material used for shall be placed in a cooling tank con- lining containers in which products are taining running cold tap water to re- packaged shall be of such kinds as do move the animal heat from the carcass. not tear readily during use, but remain Carcasses shall not be allowed to re- intact when moistened by the product. main in the cooling tank for longer Wooden containers to be used for pack- than 1 hour. aging ready-to-cook rabbits shall be (b) Air chilling. Immediately after the fully lined except when the individual initial water chilling, the carcasses carcasses to be packaged therein are shall be placed in cooling racks and fully wrapped. thereupon placed in a refrigerated cool- (i) Protective coverings shall be used er with moderate air movements and a for the product in the plant and as it is temperature which will reduce the in- distributed from the plant, as will af- ternal temperature of the carcasses to ford adequate protection for the prod- from 36 °F. to 40 °F., both inclusive, uct against contamination by any for- within 24 hours. eign substance (including, but not (c) Freezing. (1) When ready-to-cook being limited to, dust, dirt, and in- rabbits are packaged in bulk or ship- sects), considering the means intended ping containers, the carcasses should

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be individually wrapped or packaged in should be moved into the freezer, ex- water-vapor resistant cartons or the cept that a period not exceeding 72 containers should be lined with heavy hours will be permitted for transpor- water-vapor resistant paper so as to as- tation and temporary holding before sure adequate overlapping of the lining placing in the freezer provided such to completely surround the carcasses rabbits are held at not above 36 °F. and to permit unsealed closure or sealing in such a manner that water-vapor § 354.245 Vermin. loss from the product is considerably Every practicable precaution shall be retarded or prevented. The rabbit car- taken to exclude flies, rats, mice, and casses should receive an initial rapid other vermin from the official plant. freezing under such packaging, tem- Dogs, cats, and other pets shall be ex- perature, air circulation, and stacking cluded from rooms where edible prod- conditions which will result in freezing ucts are processed, handled, or stored. the carcasses solid in less than 48 hours. § 354.246 Exclusion of diseased per- (2) Frozen ready-to-cook rabbits shall sons. be held under conditions which will No person affected with any commu- maintain the product in a solidly fro- nicable disease (including, but not zen state with temperature maintained being limited to, tuberculosis) in a as constant as possible. transmissible stage shall be permitted (d) Refrigeration. Immediately after in any room or compartment where ex- packaging, all ready-to-cook rabbits, posed or unpacked edible products are other than those which are shipped prepared, processed, or otherwise han- from the plant in a refrigerated carrier, dled.

§ 354.247 Table showing types of materials.

Stainless Equipment, utensils, and facilities Iron steel and Alu- Galvanized monel metal minum iron

Holding pens ...... A A A A Overhead conveyors ...... A A A A Conveyor track ...... A A ...... A Shackles ...... A ...... A Shackle chain ...... A A ...... A Eviscerating pans ...... A A A Inspection table ...... A A A Inside and outside washer ...... A A A Cooling tanks and racks ...... A A A Utensils for handling edible products ...... A A A Framework (of equipment) ...... A ...... Key: A—Acceptable.

§ 354.248 Scope and applicability of PART 355—CERTIFIED PRODUCTS rules of practice. FOR DOGS, CATS, AND OTHER The rules of practice of the Depart- CARNIVORA; INSPECTION, CER- ment of Agriculture in subpart H of TIFICATION, AND IDENTIFICA- part I, subtitle A, title 7 of the Code of TION AS TO CLASS, QUALITY, Federal Regulations, are the rules of QUANTITY, AND CONDITION practice applicable to adjudicatory, administrative proceedings under the reg- DEFINITIONS ulations in this part (9 CFR part 354). Sec. [43 FR 11148, Mar. 17, 1978] 355.1 Meaning of words. 355.2 Terms defined.

SCOPE OF INSPECTION SERVICE 355.3 Plants eligible for inspection.

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APPLICATION FOR INSPECTION, CERTIFICATION, 355.36 Obsolete labels. AND IDENTIFICATION 355.37 Alteration or limitation of statement of certification. 355.4 Application. 355.5 Drawings. PENALTIES 355.6 Review of applications. 355.38 Withdrawal of service. INAUGURATION OF INSPECTION APPEALS 355.7 Inauguration of inspection. 355.8 Official number. 355.39 Appeals from decisions made under 355.9 Numbers granted same ownership or this part. control. REPORTS 355.10 Assignment of inspectors. 355.40 Plants to furnish information for re- FEES ports. 355.11 Charge for survey. MULE MEAT AND ANIMAL FOOD, MULE MEAT 355.12 Charge for service. BY-PRODUCT SANITATION AND FACILITIES 355.41 Antemortem and postmortem inspec- 355.13 Sanitation. tion for mules. 355.14 Facilities. 355.42 Marking of mule meat and animal 355.15 Inedible material operating and stor- food mule meat by-product. age rooms; outer premises, docks, drive- 355.43 Scope and applicability of rules of ways, etc.; fly-breeding material; practice. nuisances. AUTHORITY: 7 U.S.C. 1622, 1624; 7 CFR 2.17 355.16 Control of flies, rats, mice, etc. (g) and (i), 2.55. 355.17 Tagging equipment ‘‘U.S. rejected.’’ 355.18 Drawings and specifications to be fur- SOURCE: 23 FR 10107, Dec. 23, 1958, unless nished. otherwise noted. Redesignated at 30 FR 4195, Mar. 31, 1965. INSPECTION PROCEDURE 355.19 Inspector to be informed when plant DEFINITIONS operates. 355.20 Inspector to have access to plant at § 355.1 Meaning of words. all times. Words used in this part in the sin- 355.21 Products entering inspected plants. gular form shall be deemed to import 355.22 Designation of place of receipt of re- the plural, and vice versa, as the case turned products. may demand. 355.23 Tagging products ‘‘U.S. retained.’’ 355.24 Processes to be supervised. 355.25 Canning with heat processing and § 355.2 Terms defined. hermetically sealed containers; closures; When used in this part unless other- code marking; heat processing; incuba- wise distinctly expressed or manifestly tion. incompatible with the intent thereof: 355.26 Samples of certified products, ingre- (a) Person means any individual, dients, etc., to be taken for examination. 355.27 Reports of violations of regulations. partnership, association, business trust, corporation, or any organized DISPOSAL OF CONDEMNED MATERIAL group of persons, whether incorporated 355.28 Unfit material to be condemned. or not. (b) Program means the Meat and COMPOSITION OF CERTIFIED PRODUCTS Poultry Inspection Program of the 355.29 Composition of certified products for Food Safety and Inspection Service of dogs, cats, and other carnivora. the United States Department of Agri- culture. SUPERVISION (c) Circuit supervisor means an inspec- 355.31 Supervision by inspector. tor of the Program assigned to supervise and perform official work at a cir- LABELING cuit. Such inspector is assigned by and 355.32 Labeling required. reports directly to the Administrator 355.33 Plant number to be embossed on or other person designated by him. metal containers. 355.34 Labels, approval of, by Adminis- (d) Inspector means an inspector of trator. the Program. 355.35 Label information to be displayed on (e) Inspected plant means any plant principal panel. preparing certified products for dogs,

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cats, or other carnivora at which in- ance with § 355.41. It includes muscle spection is maintained under the regu- tissue which is found in the tongue, in lations contained in this part. the diaphragm, in the heart or in the (f) Circuit means one or more in- esophagus, with or without the accom- spected plants assigned to a circuit su- panying and overlying fat and the por- pervisor. tions of sinews, nerves, and blood ves- (g) Animal protein supplement means a sels which normally accompany the product containing animal protein and muscle tissue and which are not sepa- other elements normal to the compo- rated from it in the process of dressing. nent for use in compounding a maintenance food for dogs, cats, and other (n) Animal food mule meat by-product carnivora. means the part other than meat which (h) Products means the products for has been derived from one or more dogs, cats, and other carnivora mules that have been handled in ac- marked, or to be marked, with the cer- cordance with § 355.41 and is fit for use tification provided in this part. as animal food. (i) Meat means the U.S. inspected and (o) Bone means the U.S. inspected passed and so identified clean, whole- and passed and so identified clean, some muscle tissue of cattle, sheep, wholesome bone which has been de- swine, or goats which is skeletal or rived from cattle, sheep, swine, goats which is found in the tongue, in the di- or horses, or bone derived from mules aphragm, in the heart, or in the esoph- slaughtered and passed under Program agus with or without the accom- inspection in accordance with § 355.41. panying and overlying fat and the por- (p) Poultry means any domesticated tions of skin, sinews, nerves, and blood bird slaughtered in accordance with vessels which normally accompany the the Poultry Products Inspection Act, muscle tissue and which are not separated from it in the process of dressing. Public Law 85–172, 85th Congress, S. It does not include the muscle found in 1747, dated August 28, 1957 (21 U.S.C. 451 the lips, snout, or ears. et seq.). (j) Animal food meat by-product means (q) Poultry product means any edible the part other than meat which has part of fresh poultry which have been been derived from one or more cattle, slaughtered for human food and from sheep, swine or goats that have been which the blood, feathers, feet, head U.S. Inspected and Passed and is fit for and viscera have been removed in ac- use as animal food. cordance with rules and regulations (k) Horse meat means the U.S. in- promulgated by the Secretary of Agri- spected and passed and so identified culture. clean, wholesome muscle tissue of (r) Administrator. The Administrator horses which is skeletal or which is of the Food Safety and Inspection found in the tongue, in the diaphragm, Service or any officer or employee of in the heart, or in the esophagus, with the Department to whom authority has or without the accompanying and over- heretofore been delegated or may here- lying fat and the portions of sinews, nerves, and blood vessels which nor- after be delegated to act in his stead. mally accompany the muscle tissue (s) Whale meat means the muscle tis- and which are not separated from it in sue of whales which is fit for use in ani- the process of dressing. mal food. (l) Animal food horse meat by-product (t) Fish means the whole or part of means the part other than meat which any aquatic, water breathing has been derived from one or more vertebrates, commonly designated as horses that have been U.S. Inspected fish, which is fit for use in animal food. and Passed and is fit for use as animal (u) Animal food poultry byproduct food. means any portion of carcasses of poul- (m) Mule meat means the clean, try slaughtered under inspection and sound, healthful, wholesome muscle passed in accordance with the Poultry tissue derived from mules as determined by antemortem and postmortem inspection by an inspector in accord-

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Products Inspection Act which is fit for U.S. Department of Agriculture, cov- use in animal food. ering a plant operating under the su- [23 FR 10107, Dec. 23, 1958, as amended at 25 pervision of that Program, it will not FR 1356, Feb. 1960; 29 FR 18418, Dec. 25, 1964. be necessary that drawings and speci- Redesignated and amended at 30 FR 4195, fications accompany an application Mar. 31, 1965; 32 FR 13115, Sept. 15, 1967; 33 FR made under this part for inspection at 6707, May 2, 1968] such plant. SCOPE OF INSPECTION SERVICE [23 FR 10107, Dec. 23, 1958. Redesignated and amended at 30 FR 4195, Mar. 31, 1965; 32 FR § 355.3 Plants eligible for inspection. 13115, Sept. 15, 1967] Upon application, inspection may be granted at a plant where products are § 355.6 Review of applications. to be prepared, when the Administrator The Administrator will determine has determined that the application whether applications shall be granted conforms to and the plant meets with or refused. the requirements of this part. INAUGURATION OF INSPECTION APPLICATION FOR INSPECTION, CERTIFICATION, AND IDENTIFICATION § 355.7 Inauguration of inspection. § 355.4 Application. When an application for inspection, The owner or operator of any plant of certification, and identification is the kind specified in § 355.3 may apply granted, the circuit supervisor shall, at to the Administrator for inspection, or prior to the inauguration of inspec- certification, and identification. In tion, inform the owner or operator of cases of change of ownership or change the plant of the requirements of the of location, new applications shall be regulations contained in this part. In- made. spection shall not be begun if a plant is (Approved by the Office of Management and not in a sanitary condition. The appli- Budget under control number 0583–0036) cant shall adopt and enforce all necessary measures and shall comply with [23 FR 10107, Dec. 23, 1958. Redesignated at 30 FR 4195, Mar. 31, 1965, and amended at 47 FR all such directions as the circuit super- 746, Jan. 7, 1982] visor may prescribe for carrying out the purposes of this part. § 355.5 Drawings. Triplicate copies of complete draw- § 355.8 Official number. ings with specifications, consisting of To each plant granted inspection an floor plans showing the locations of official number shall be assigned. Such such features as the principal pieces of number shall be preceded by the letter equipment, floor drains, principal ‘‘A’’ and used to identify all certified drainage lines, hand-washing basins, products prepared in the plant. and hose connections for cleanup purposes; elevations; roof plans when nec- § 355.9 Numbers granted same owner- essary to show size and location of sky- ship or control. lights and the like; cross and longitu- Two or more official plants under the dinal sections of the various buildings, same ownership or control may be showing such features as principal pieces of equipment, heights of ceil- granted the same official number, pro- ings, conveyor rails, and character of vided a serial letter is added after the floors, walls, and ceilings; and a plot number in each case to identify the plan showing relationship of various plant. departments and structures of the plants, properly drawn to scale, shall § 355.10 Assignment of inspectors. accompany applications. Where com- The Administrator shall designate a plete approved drawings and specifica- circuit supervisor of the inspection at tions are available in the files of the each circuit and assign to him such as- Meat and Poultry Inspection Program, sistants as may be necessary. Food Safety and Inspection Service,

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FEES tion as will make them susceptible of being readily and thoroughly cleaned. § 355.11 Charge for survey. (f) Trucks and receptacles used for Applicants for the inspection, certifi- inedible materials shall be of such con- cation, and identification shall reim- struction as to permit ready and thor- burse the department for salary, travel ough cleansing, shall bear a con- cost, per diem allowance, and the like, spicuous and distinctive mark, and expended incidental to any survey of shall be used exclusively for handling the premises for which the inspection inedible material. is requested, and in connection with (g) Rooms, compartments, places, any review of plans which may be equipment and utensils used for pre- made. paring, storing or otherwise handling any certified products, and all other § 355.12 Charge for service. parts of the inspected plant, shall be The fees to be charged and collected kept clean. There shall be no handling by the Administrator shall be at the or storing of materials which creates rates specified in §§ 391.2, 391.3, and 391.4 an objectionable condition in rooms, respectively for base time; for over- compartments or places where certified time, including Saturdays, Sundays, products are prepared, stored or other- and holidays; and for certain labora- wise handled. tory services which are not covered under the base time, overtime, and/or § 355.14 Facilities. holiday costs. Such fees shall reim- Adequate facilities for the prepara- burse the Service for the cost of the in- tion and inspection of the products to spection service furnished. be certified shall be furnished and [54 FR 6390, Feb. 10, 1989] maintained by the inspected plant. Of these the following are specifically re- SANITATION AND FACILITIES quired: (a) A room or compartment ade- § 355.13 Sanitation. quately equipped for locking or sealing Sanitary facilities and accommoda- shall be provided for holding products tions shall be furnished by every in- prepared for certification or material spected plant. Of these the following used in their preparation which are are specifically required: identified as ‘‘U.S. retained,’’ and such (a) Dressing rooms, toilet rooms, and rooms and compartments shall be con- urinals shall be sufficient in number, spicuously marked with the phrase ample in size, and conveniently lo- ‘‘U.S. retained’’ prominently displayed. cated. They shall be properly lighted (b) Adequate facilities, including de- and ventilated and of sanitary con- naturing materials, for the proper dis- struction. They shall be separate from posal of condemned articles including the rooms and compartments in which carcasses, parts of carcasses and other certified products are prepared, stored materials, shall be provided. or handled. (c) Rooms or compartments adequate (b) Modern hand-washing basins, in- in size and properly equipped for hold- cluding running hot and cold water, ing samples of canned products pre- soap and towels shall be placed in or pared for certification under incuba- near toilet rooms. tion, shall be maintained at the tem- (c) Toilet soil lines shall be separate perature specified in § 355.25(i). from house drainage lines to a point (d) Furnished office room, including outside the buildings and drainage light, heat, janitor, and laundry service from toilet soil lines shall not be dis- shall be provided rent free for the ex- charged into a grease catchbasin. clusive use of the inspector. These fa- (d) Properly located facilities shall cilities shall be set apart for this pur- be provided for cleansing utensils and pose and provided with lockers suitable hands of all persons handling or pre- for the protection and storage of pro- paring any products to be certified. gram supplies. Laundering of inspec- (e) Equipment and utensils used for tors’ outer work clothing shall be pro- preparing any products to be certified vided by the management of inspected shall be of such material and construc- plants.

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§ 355.15 Inedible material operating INSPECTION PROCEDURE and storage rooms; outer premises, docks, driveways, etc.; fly-breeding § 355.19 Inspector to be informed when material; nuisances. plant operates. All operating and storage rooms and The management of an inspected departments of inspected plants used plant shall inform the inspector or the for inedible material shall be main- circuit supervisor when work in each department has been concluded for the tained in clean condition, and shall be day, and the day and hour when work separate and apart from rooms and de- will be resumed therein. There shall be partments where certified products are no preparation of certified products at prepared, handled, or stored. Docks and an inspected plant except under the su- areas where cars and vehicles are load- pervision of an inspector. ed, and driveways, approaches and alleyways shall be properly paved and § 355.20 Inspector to have access to drained and the outer premises of every plant at all times. inspected plant shall be kept in clean For the purpose of examination or in- and orderly condition. All catchbasins spection necessary to enforce any of on the premises shall be of such con- the provisions of this part, inspectors struction and location and shall be shall have access at all times by day or given such attention as will insure night, whether the plant is being oper- their being kept in acceptable condi- ated or not, to every part of an in- tion as regards odors and cleanliness. spected plant. The accumulation on the premises of any material in which flies may breed, § 355.21 Products entering inspected plants. or the maintenance of any nuisance on the premises shall not be allowed. All products of a kind certified under this part or materials to be used in the § 355.16 Control of flies, rats, mice, etc. preparation of such products when brought into an inspected plant shall Flies, rats, mice, and other vermin be identified and inspected at the time shall be excluded from inspected plants of receipt and be subject to further in- and premises. spection in such manner and at such time as may be deemed necessary. If, § 355.17 Tagging equipment ‘‘U.S. re- upon inspection, any such article is jected.’’ found to be unsound or otherwise unfit, When necessary, inspectors shall at- it shall be handled as provided in tach a ‘‘U.S. rejected’’ tag to any § 355.28. equipment or utensil which is unclean or the use of which would be in conflict § 355.22 Designation of place of receipt with the provisions of this part. No of returned products. equipment or utensil so tagged shall Certified products returned to an in- again be used until made acceptable spected plant shall be received at a under this part and until removal of dock or place specifically designated the tag. Such tag shall not be removed for the purpose by the plant manage- from the equipment or utensil by any- ment with the approval of the circuit one other than an inspector. supervisor. Such returned products shall be inspected there by the inspec- § 355.18 Drawings and specifications tor before further entering the plant. to be furnished. § 355.23 Tagging products ‘‘U.S. re- Triplicate copies of complete draw- tained.’’ ings and specifications for remodeling A ‘‘U.S. Retained’’ tag shall be placed inspected plants or for new structures by an inspector at the time of inspec- at such plants shall be submitted to tion on all certified products, mate- the Administrator and approval ob- rials to be used in the preparation of tained for the plans in advance of con- certified products, or containers there- struction. of, whenever such certified products, materials, or containers are suspected

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of being unsound or otherwise unfit or conditions that will promptly and ef- not in conformity with the require- fectively chill them until the following ments contained in this part. Such tags day when the defect may be corrected; so placed shall not be removed by any- and (2) short vacuum or overstuffed one other than an inspector. cans of products which have not been handled in accordance with the above § 355.24 Processes to be supervised. may be incubated as provided in para- All processes used in the preparation graph (i) of this section in the in- of the certified products shall be super- spected plant under Program supervised by an inspector. All steps in the vision, after which the cans shall be process of manufacture shall be con- opened and the sound products passed. ducted carefully and with strict clean- (e) Canned products shall not be liness. Inspected plants shall not pre- passed unless, after cooling to atmos- pare products of a kind certified under pheric temperature, they show the ex- this part unless they conform with the ternal characteristic of sound cans; regulations contained in this part. that is, the cans shall not be overfilled, the ends of the cans shall be concave, § 355.25 Canning with heat processing there shall be no bulging of the cans, and hermetically sealed containers; the sides and ends of the cans shall closures; code marking; heat proc- conform to the products, and there essing; incubation. shall be no slack or loose tin in the (a) Containers shall be cleaned thor- cans. oughly immediately before filling, and (f) All canned products shall be plain- precaution must be taken to avoid soil- ly and permanently marked on the con- ing the inner surfaces subsequently. tainers by code or otherwise with the (b) The inside surfaces of containers identity of the contents and date of of metal, glass, or other material shall canning. The code used and its mean- be washed by spraying in an inverted ing shall be on record in the office of position with running water at a tem- the circuit supervisor before use. perature of at least 180 °F. The con- (g) The canned products must be tainer washing equipment shall be pro- processed at such temperature and for vided with a thermometer to register such period of time as will assure keep- the temperature of the water used for ing without refrigeration under usual cleaning the containers. conditions of storage and transpor- (c) Perfect closure is required for her- tation as evidenced by the incubation metically sealed containers. Heat proc- test. essing shall follow promptly after clos- (h) Lots of canned products shall be ing. identified during their handling pre- (d) Careful inspection shall be made paratory to and during heat processing of the containers by competent plant by tagging the baskets or cages in employees immediately after closing, which the cans are being conveyed, and containers which are defectively with a tag which will change color on filled or defectively closed, or which going through the heat processing or show inadequate vacuum, shall not be by other effective means so as to insure further processed until the defect has the proper channeling of the products been corrected. The containers shall for effective heat processing after clos- again be inspected by plant employees ing the cans. when they have cooled sufficiently for (i) Facilities shall be provided to in- handling after processing by heating. cubate at least representative samples The contents of defective containers of the fully processed canned products. shall be condemned unless correction The incubation shall consist of holding of the defect is accomplished within six the canned products for at least 10 days hours following the sealing of the con- at about 98 °F. The extent to which in- tainers or completion of the heat proc- cubation tests shall be required by in- essing, as the case may be, except that spectors depends on conditions such as (1) if the defective condition is discov- the record of the inspected plant in ered during an afternoon run the cans conducting canning operations, the ex- of product may be held in coolers at a tent to which the plant furnishes com- temperature not exceeding 38 °F. under petent supervision and inspection in

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connection with the canning oper- mate use for some purpose other than ations, the character of the equipment the preparation of the certified prod- used, and the degree to which such ucts, they may be released by author- equipment is maintained at maximum ized inspectors for such other purpose efficiency. Such factors shall be consid- for disposition under the supervision of ered by the circuit supervisor in deter- the proper local, State, or Federal offi- mining the extent of incubation testing cial. The operator of the inspected at a particular plant. In the event of plant shall make such arrangement as failure by an inspected plant to provide may be necessary with the proper offi- suitable facilities for incubation of test cials for the disposition of the article. samples, the circuit supervisor may require holding of the entire lot under COMPOSITION OF CERTIFIED PRODUCTS such conditions and for such period of time as may, in his discretion, be nec- § 355.29 Composition of certified prod- essary to establish the stability of the ucts for dogs, cats, and other canned products. The circuit supervisor carnivora. may permit lots of canned certified (a) Composition of canned or semi-moist products to be shipped from the in- certified maintenance food. (1) Only inspected plant prior to completion of gredients which are normal to canned sample incubation when he has no rea- or semi-moist food for dogs, cats, and son to suspect unsoundness in the par- other carnivora, which are favorable to ticular lots, and under circumstances adequate nutrition, and which are which will assure the return of the classed by the Administrator as con- products to the plant for inspection forming with requirements contained should such action be indicated by the in this part shall be used in the prepa- incubation results. ration of certified maintenance food. (2) Not less than 30 percent of meat § 355.26 Samples of certified products, or animal food meat byproduct or both, ingredients, etc., to be taken for examination. or of horse meat or animal food horse meat byproduct or both, or of mule Samples of certified products, water, meat or animal food mule meat by- chemicals, flavorings or other articles product or both, or of poultry products, in an inspected plant shall be taken shall be used in the preparation of without cost to the Program for an ex- canned or semimoist certified mainte- amination as often as may be deemed nance food. Upon specific approval of necessary for the efficient conduct of the Administrator, combinations of the the inspection. The frequency of sam- above specified ingredients may be pling shall be determined by the needs used. The uncooked weight of the meat of the inspection. or animal food meat byproduct or both, § 355.27 Reports of violations of regu- or of the horse meat or animal food lations. horse meat byproduct or both, or of the mule meat or animal food mule meat Inspectors shall report to the circuit byproduct or both, or of the poultry supervisor violations of or failures to products, or of the combinations there- conform with these regulations which of, shall be used in the calculation, and occur at inspected plants, and the cir- the percentage shall be obtained by re- cuit supervisor shall report the same to lating this weight to the total weight the Administrator. of the certified maintenance food. DISPOSAL OF CONDEMNED MATERIAL (3) Certified maintenance food shall contain not less than 10 percent of pro- § 355.28 Unfit material to be con- tein. demned. (4) Certified maintenance food shall Subject to § 355.41, any certified prod- contain a level of minerals and vita- ucts, or ingredients intended for use mins generally recognized to be essen- therein, which are decomposed or adul- tial to the nutritional value of the terated or otherwise unsound or unfit food. for use shall be condemned and de- (5) Vegetables and grains and their stroyed, except that if the adulteration derivatives, used as ingredients of cer- is such as will not preclude their legiti- tified maintenance food, shall be of

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good quality, shall be free from discol- of meat or animal food meat byproduct oration, mold, smut, and insect infesta- or both, or of horse meat or animal tion, and shall be otherwise fit for use food horse meat byproduct or both, or as animal food. of mule meat or animal food mule (6) Inedible material such as tankage, meat byproduct or both, or of poultry dried blood, bone meal, and the like products. Upon specific approval of the shall not be used as ingredients of cer- Administrator, combinations of the tified maintenance food. above specified ingredients may be (7) Semi-moist certified maintenance used; food shall have a soft granular consist- (ii) Certified pet food supplement ency, shall be shelf stable, and shall be shall have added thereto a sufficient processed so that the moisture content amount of fresh ground bone or other thereof does not exceed 27 percent of acceptable agent to satisfy the require- the net weight of such food. ments of the regulations promulgated (b) Composition of canned or fresh fro- under the Meat Inspection Act (34 Stat. zen certified supplemental animal foods. (1) Certified animal protein supplement 1260), as amended (21 U.S.C. 71 et seq.), shall comply with the following re- and the Horse Meat Act (41 Stat. 241; 21 quirements: U.S.C. 96), in order to insure (i) Certified animal protein supple- decharacterization of the product for ment shall contain not less than 95 per- human food purposes; cent of meat or animal food meat by- (iii) Certified pet food supplement product or both, or of horse meat or may contain various cereals, flours, animal food horse meat byproduct or vegetables, flavorings, seasonings and both, or of mule meat or animal food other processing aids acceptable to the mule meat byproduct or both, or of Administrator which shall be of good poultry products. Upon specific ap- quality, shall be free from discolora- proval of the Administrator, combination, mold, smut, and insect infesta- tions of the above specified ingredients tion, and shall be otherwise fit for use may be used; as animal food; (ii) Certified animal protein supple- (iv) Certified pet food supplement ment shall have added thereto a suffi- shall contain not less than 11 percent cient amount of fresh ground bone or protein; other acceptable agent to satisfy the (v) Certified pet food supplement requirements of the regulations pro- shall contain not less than 3 percent mulgated under the Meat Inspection fat; and Act (34 Stat. 1260), as amended (21 (vi) Certified pet food supplement U.S.C. 71 et seq.), and the Horse Meat may not contain more than 74 percent Act (41 Stat. 241; 21 U.S.C. 96), in order moisture. to insure decharacterization of the (c) Composition of canned certified vari- product for human food purposes; ety pet food. (1) Certified variety pet (iii) Certified animal protein supple- food shall contain not less than 25 per- ment may contain not more than 3 percent of meat or animal food meat by- cent wheat flour or other processing aid acceptable to the Administrator, product or both, or of horse meat or which shall be of good quality, shall be animal food horse meat byproduct or free from insect infestation, and shall both, or of mule meat or animal food be otherwise fit for use as animal food; mule meat byproduct or both, or of (iv) Certified animal protein supple- poultry products. Upon specific ap- ment shall contain not less than 15 per- proval of the Administrator, combina- cent protein; and tions of the above specified ingredients (v) Certified animal protein supple- may be used. ment shall contain not less than 3 per- (2) Certified variety pet food shall cent fat. contain a variety of vegetables and (2) Certified pet food supplement may contain other ingredients which shall comply with the following re- are favorable to adequate nutrition. quirements: (3) Vegetables and grains and their (i) Certified pet food supplement derivatives used as ingredients of cer- shall contain not less than 50 percent tified variety pet food shall be of good

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quality, shall be free from discolora- ‘‘dog and cat food,’’ or ‘‘fox food,’’ action, mold, smut, and insect infesta- companied with such references to option, and shall be otherwise fit for use tional ingredients as may be required as animal food. by the Administrator under this part. (4) Certified variety pet food shall Product names shall not be misleading contain not less than 8 percent protein. in regard to class of canned or semi- (5) Certified variety pet food shall moist certified food for which label is contain not less than 2 percent fat. intended. (6) Certified variety pet food may (2) Class of product as outlined in contain not more than 75 percent mois- paragraphs (a), (b), and (c) of § 355.29 ture. shall be declared on either the main (d) Certified products for dogs, cats, display or 20 percent panel of the label. and other carnivora may contain whale (3) The word ‘‘ingredients,’’ followed meat, fish, and animal food poultry byproducts or combinations thereof as by a complete list of ingredients of the optional ingredients in lieu of some but food in the order of their predominance not all of the ingredients named in and by their common or usual names, paragraphs (a)(2), (b)(1)(i), and (c)(1) of shall appear on the label with the name this section, respectively, upon specific of the food. approval of the Administrator. (4) The inspection legend for canned, semi-moist or frozen certified animal [26 FR 3984, May 9, 1961, as amended at 29 FR food shall appear on the label in the 9819, July 22, 1964; 29 FR 18419, Dec. 25, 1964. Redesignated at 30 FR 4195, Mar. 31, 1965, and form shown herewith, except that the amended at 30 FR 10284, Aug. 19, 1965; 32 FR plant number need not appear with the 13115, Sept. 15, 1967; 33 FR 6707, May 2, 1968] legend when such number is embossed on the sealed metal container as pro- SUPERVISION vided in § 355.33. § 355.31 Supervision by inspector. No container which bears or is to bear a label as provided for under this part shall be filled in whole or in part except with certified products which have been inspected in compliance with this part, which are sound, healthful, wholesome, and otherwise fit for dogs, cats, and other carnivora, and which are strictly in accordance with the (5) When a product is prepared in statements on the label. No such con- whole from any of the items defined in tainer shall be filled in whole or in part § 355.2 (i) through (n), its name shall and no such label shall be affixed there- identify the item and there shall ap- to except under the supervision of an pear contiguous to the name of the inspector. item the name of the decharacterizing agent used, followed by the word LABELING ‘‘added’’ as, for example, ‘‘bone added.’’ § 355.32 Labeling required. (6) When wheat flour or other processing aid is added to the product, Each container of inspected and cer- there shall appear on the label, with tified product shall have affixed there- the name of the decharacterizing to a label bearing the following information, prominently displayed: agent, in predominating order, the (a) The name of the product, class of name of the processing aid, as, for ex- product, ingredient statement, and the ample, ‘‘Wheat flour and bone added’’ animal foods inspection legend in the or ‘‘Bone and wheat flour added.’’ manner provided by paragraphs (a) (1), (b) A statement of the quantity of (2), (3), (4), (5), and (6) of this section. contents of the container, representing (1) The name of the canned or in terms of avoirdupois weight the semimoist certified food shall include quantity of product in the container. words such as ‘‘dog food,’’ ‘‘cat food,’’

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(c) The name and place of business of as it will appear on the package, in- the manufacturer, packer, or dis- cluding any color scheme involved. tributor. The name under which inspec- (b) Inserts, tags, liners, pasters, and tion is granted to a plant may appear like devices containing printed or without qualification on the label of a graphic matter for use on, or to be product prepared by that plant. When placed within, containers and coverings the certified product is not prepared by of certified products shall be submitted the person whose name appears on the for approval in the same manner as label, the name shall be qualified by a provided for labels in paragraph (a) of phrase which reveals the connection this section, except that inspectors in such person has with the product as, charge may permit the use of such de- for example, ‘‘Prepared for vices if they contain no reference to llllllllll.’’ the certified products and bear no mis- [23 FR 10107, Dec. 23, 1958, as amended at 25 leading feature. FR 1357, Feb. 16, 1960; 26 FR 3984, May 9, 1961; (c) Stencils, labels, box dies, and 29 FR 9819, July 22, 1964. Redesignated at 30 brands may be used on shipping con- FR 4195, Mar. 31, 1965, and amended at 32 FR tainers, including tierces, barrels, 13115, Sept. 15, 1967] drums, boxes, crates, and large-size fiberboard containers, without approval § 355.33 Plant number to be embossed on metal containers. by the Administrator, provided the markings are applicable to the cer- The official number assigned to an tified products, are not false or decep- inspected plant under § 355.8 shall be tive, and are used with the approval of embossed on all sealed metal con- the circuit supervisor. tainers of certified products filled in (d) No certified product and no con- such plant, except that such containers tainer thereof shall be labeled with any which bear labels lithographed directly false or deceptive term, and no state- on the container and in which the ment, word, picture, design, or device plant number is incorporated need not which conveys any false impression or have the plant number embossed thereon. Labels and embossed code identi- gives any false indication of the origin, fication shall be affixed so as not to ob- quality, or quantity of the product scure the embossed plant number. shall appear on any label. [23 FR 10107, Dec. 23, 1958. Redesignated and § 355.35 Label information to be dis- amended at 30 FR 4195, Mar. 31, 1965; 32 FR played on principal panel. 13115, Sept. 15, 1967; 38 FR 29215, Oct. 23, 1973] The label information required by § 355.34 Labels, approval of, by Admin- § 355.32 shall be displayed on the prin- istrator. cipal panel or panels of the label except that label information other than the (a) Except as provided in paragraph name of the product and the ingredient (c) of this section, no label shall be statement may be displayed on a panel used on any container of certified prod- immediately adjacent to the principal ucts until it has been approved by the panel or panels if such supplemental Administrator. For the convenience of panel consists of at least 20 percent of the inspected plant, sketches or proofs the label and is reserved exclusively for of proposed labels may be submitted in required labeling information. triplicate to the Administrator for approval, and the preparation of the fin- § 355.36 Obsolete labels. ished labels deferred until such approval is obtained. All finished labels At least once each year, each in- shall be submitted in quadruplicate to spected plant shall submit to the Ad- the Administrator for approval. In the ministrator, in quadruplicate, a list of case of lithographed labels, paper take- approvals for labels that have become offs in lieu of sections of the metal obsolete, accompanied by a statement containers shall be submitted for ap- that such approvals are no longer de- proval. Such paper take-offs shall not sired. The approvals shall be identified be in the form of a negative but shall by the number, the date of approval, be a complete reproduction of the label and the name of the product.

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§ 355.37 Alteration or limitation of rules of practice (7 CFR 1.147(b)). In statement of certification. other cases, prior to the institution of The statement of certification pro- proceedings for any withdrawal or sus- vided for by § 355.32(a)(4) shall not be al- pension, the facts or conduct which tered, defaced, imitated, or simulated may warrant such action shall be in any respect or used for the purpose called to the attention of the operator of misrepresentation or deception. in writing and he shall be given an opportunity to demonstrate or achieve [25 FR 1357, Feb. 16, 1960. Redesignated at 30 compliance with the requirements of FR 4195, Mar. 31, 1965] the regulations in this part and in- PENALTIES structions and directions issued thereunder. § 355.38 Withdrawal of service. [23 FR 10107, Dec. 23, 1958. Redesignated at 30 After opportunity for hearing before FR 4195, Mar. 31, 1965, and amended at 43 FR a proper official of the Department has 11148, Mar. 17, 1978] been accorded the operator of an inspected plant, the inspection, certifi- APPEALS cation, and identification provided for § 355.39 Appeals from decisions made in this part may be withdrawn from under this part. such plant if the operator: (a) Persist- ently fails to comply with any provi- Any appeal from a decision by an em- sion of the regulations in this part or ployee of the Program shall be made to of instructions or directions issued his immediate superior having jurisdic- thereunder; (b) makes any willful mis- tion over the subject matter of the ap- representation or engages in any fraud- peal. ulent or deceptive practice in connec- REPORTS tion with the making of any application for service; (c) violates § 355.37; or § 355.40 Plants to furnish information (d) interferes with or obstructs any for reports. program employee in the performance of his duties under the regulations in Each day the operator of every in- this part by intimidation, threats, or spected plant shall furnish the inspec- other improper means. Pending final tor assigned to that plant with a state- determination of the matter, the Ad- ment of the number of pounds of prod- ministrator may suspend such inspec- uct certified by the inspector. tion, certification, and identification (Approved by the Office of Management and without hearing in cases of willfulness Budget under control number 0583–0036) or those in which the public health, in- [23 FR 10107, Dec. 23, 1958. Redesignated at 30 terest, or safety requires such action. FR 4195, Mar. 31, 1965, and amended at 47 FR The operator of the inspected plant 746, Jan. 7, 1982] shall be notified of the Administrator’s decision to suspend such inspection, MULE MEAT AND ANIMAL FOOD, MULE certification or identification service, MEAT BY-PRODUCT and the reasons therefor, in writing, in the manner prescribed in § 1.147(b) of § 355.41 Antemortem and postmortem the rules of practice (7 CFR 1.147(b)), or inspection for mules. orally. The Administrator’s decision to (a)(1) An antemortem examination suspend such inspection, certification and inspection shall be made of all or identification service shall be effec- mules about to be slaughtered for use tive upon such oral or written notifica- in the preparation of products under tion, whichever is earlier, to the oper- this part, before their slaughter shall ator of the plant. If such notification is be allowed for such use. Such inspec- oral, the Administrator shall confirm tion shall be made on the day of such decision and the reasons therefor, slaughter. in writing, as promptly as cir- (2) Mules found on such inspection to cumstances permit, and such written show symptoms of disease shall be set confirmation shall be served upon the apart and slaughtered separately. operator of the inspected plant, in the Those found to be affected with stran- manner prescribed in § 1.147(b) of the gles, purpura hemorrhagica, azoturia,

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infectious equine encephalomyelitis, PART 362—VOLUNTARY POULTRY toxic encephalomyelitis (forage poi- INSPECTION REGULATIONS soning), infectious anemia (swamp fever), dourine, acute influenza, gener- Sec. alized osteoporosis, glanders, farcy, or 362.1 Definitions. other malignant disorder, acute in- 362.2 Types and availability of service. flammatory lameness or extensive fis- 362.3 Application for service. tula, shall be condemned and de- 362.4 Denial or withdrawal of service. stroyed. Any mule which is suspected 362.5 Fees and charges. on antemortem inspection of being in- AUTHORITY: 7 U.S.C. 1622; 7 CFR 2.18 (g) and fected with glanders shall be tested (i) and 2.53. with mallein, and any mule which on physical examination is suspected of SOURCE: 41 FR 23715, June 11, 1976, unless otherwise noted. being affected with dourine shall be held for further examination or for § 362.1 Definitions. such test as the Administrator may prescribe. The definitions in § 381.1 are incor- (b)(1) A careful postmortem examina- porated in this part except for the defi- tion and inspection shall be made of all nitions excluded in § 362.2(a). In addi- carcasses and parts thereof of all mules tion to those definitions, the following inspected under this section, at the definitions will be applicable to the time of slaughter. All carcasses and regulations in this part. parts of mules found to be affected (a) Act. ‘‘Act’’ means the Agricul- with any disease listed under para- tural Marketing Act of 1946, as amend- graph (a) of this section shall be con- ed (60 Stat. 1087, as amended; 7 U.S.C. demned and destroyed. 1621 et seq.). (2) Other carcasses and parts of mules (b) Inspector. ‘‘Inspector’’ means any found abnormal or diseased upon in- officer or employee of the Department authorized to perform any duties under spection under this section shall be dis- the regulations in this part. posed of in accordance with such provisions of the Meat Inspection Regula- (c) Person. ‘‘Person’’ means any indi- tions (subchapter A of this chapter) as vidual, corporation, company, associa- are deemed applicable by the Adminis- tion, firm, partnership, society, or trator. joint stock company, or other organized business unit. § 355.42 Marking of mule meat and (d) Poultry. ‘‘Poultry’’ means any mi- animal food mule meat by-product. gratory water fowl or game bird, whether dead or alive. All mule meat and animal food mule (e) Poultry Product. ‘‘Poultry prod- meat by-product inspected under this uct’’ means any poultry carcass or part part shall be marked and identified as thereof; or any human food product the Administrator may require in any which is made wholly or in part from particular case. the carcass of any domesticated bird [25 FR 1357, Feb. 16, 1960. Redesignated at 30 (as defined in § 381.1(b) of this chapter) FR 4195, Mar. 31, 1965, and amended at 32 FR and is excepted from the inspection re- 13115, Sept. 15, 1967] quirements of the Poultry Products In- spection Act (21 U.S.C. 451 et seq.). § 355.43 Scope and applicability of rules of practice. [66 FR 22905, May 7, 2001] The rules of practice of the Depart- § 362.2 Types and availability of serv- ment of Agriculture in subpart H of ice. part I, subtitle A, title 7 of the Code of Upon application, in accordance with Federal Regulations, are the rules of § 362.3, the following types of service practice applicable to adjudicatory, may be furnished under the regulations admininstrative proceedings under the in this part: regulations in this part (9 CFR part (a) Inspection service. An inspection 355). and certification service for whole- [43 FR 11148, Mar. 17, 1978] someness relating to the slaughter and

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processing of poultry and the proc- (3) The mark of inspection shall be essing of poultry products. All provi- applied only under the immediate su- sions of Part 381 and §§ 416.1 through pervision of an inspector. 416.6 of this chapter shall apply to the (4) This service does not cover fur- slaughter of poultry, and the prepara- ther cutting and processing of prod- tion, labeling, and certification of the ucts. These activities must take place poultry and poultry products processed at an official establishment. under this poultry inspection service (5) The registration and record- except for the following provisions: the keeping requirements enumerated in definitions of ‘‘Act,’’ ‘‘animal food Part 381, subpart Q, of this chapter manufacturer,’’ ‘‘Inspection Service,’’ shall apply to persons requesting vol- ‘‘inspector,’’ ‘‘Inspector in Charge,’’ untary identification service under this ‘‘poultry,’’ ‘‘poultry product,’’ ‘‘poultry paragraph (c). food product,’’ ‘‘poultry products [66 FR 22905, May 7, 2001] broker,’’ ‘‘renderer,’’ and ‘‘U.S. Refused Entry’’ in §§ 381.1 (b), 381.3 (a), 381.6, § 362.3 Application for service. 381.10, 381.13–381.17, 381.21, 381.29, 381.39– Any person who desires to receive 381.42, 381.175 (a)(2), 381.175 (a)(3), service under the regulations in this 381.179, 381.185–381.187, 381.192, and part for poultry or other product eligi- 381.195–381.225. ble therefor under such regulations (b) Export certification service. At the may make application for service to request of any person intending to ex- the Administrator, upon an application port any slaughtered poultry or poul- form which will be furnished by the Ad- try product, inspectors may make cer- ministrator upon request to the Meat tification regarding products for and Poultry Inspection Program, Food human food purposes, to be exported, Safety and Inspection Service, U.S. De- as meeting conditions or standards partment of Agriculture, Washington, that are not imposed or are in addition DC 20250. The application must include to those imposed by the regulations in all the information called for by that this chapter and the laws under which form. In case of change of name, owner- such regulations were issued. ship, management, or location, a new (c) Identification Service. (1) Poultry application shall be made. or other product that is federally in- (Approved by the Office of Management and spected and passed at an official estab- Budget under control number 0583–0036) lishment, or upon importation, under [41 FR 23715, June 11, 1976, as amended at 47 the Poultry Products Inspection Act, is FR 746, Jan. 7, 1982] officially marked to identify it as federally inspected and passed. In order to § 362.4 Denial or withdrawal of serv- facilitate the division of such poultry ice. or other product into smaller portions (a) For disciplinary reasons—(1) Bases or its combination into larger units for denial or withdrawal. An application and still maintain its identify as prod- or request for service may be rejected, uct which has been federally inspected or the benefits of the service may be and passed and so marked, inspectors otherwise denied to, or withdrawn may supervise the handling and weigh- from, any person who, or whose em- ing of the product and mark such por- ployee or agent in the scope of his em- tions and units with the official mark ployment or agency, (i) has willfully of inspection when they determine that made any misrepresentation or has identify has been maintained. committed any other fraudulent or de- (2) At the time service is furnished, ceptive practice in connection with any product must be sound, wholesome, and application or request for service under fit for human food. The service will be the regulations in this chapter; (ii) has available only on premises other than given or attempted to give, as a loan or those of an official establishment. The for any other purpose, any money, sanitation of the place or area where favor, or other thing of value, to any service is furnished must comply with employee of the Department author- provisions of §§ 416.1 through 416.6 of ized to perform any function under the this chapter. regulations in this chapter; (iii) has

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interfered with or obstructed, or at- tor; And provided further, That an appli- tempted to interfere with or to ob- cation or a request for service may be struct, any employee of the Depart- rejected, or the benefits of the service ment in the performance of his duties may be otherwise denied to, or with- under the regulations in this chapter drawn from any person who operates by intimidation, threats, assaults, an establishment for which he has abuse, or any other improper means; made application for service if, with (iv) has knowingly falsely made, the knowledge of such operator, any issued, altered, forged, or counterfeited other person conducting any oper- any official certificate, memorandum, ations in such establishment has com- mark, or other identification, or device mitted any of the offenses specified in for making any such mark or identi- paragraphs (a)(1) (i) through (ix) of this fication authorized or issued under this section after such application was chapter; (v) has knowingly uttered, made. Moreover, an application or a re- published, or used as true any such quest for service made in the name of a falsely made, issued, altered, forged, or person otherwise eligible for service counterfeited certificate, memo- under the regulations may be rejected, randum, mark, identification, or de- or the benefits of the service may be vice; (vi) has knowingly obtained or re- otherwise denied to, or withdrawn tained possession of any such falsely from, such a person (a) in case the serv- made, issued, altered, forged, or coun- ice is or would be performed at an es- terfeited certificate, memorandum, tablishment operated (1) by a corpora- mark, identification, or device, or of tion, partnership, or other person from any carcass or poultry or product bear- whom the benefits of the service are ing any such falsely made, issued, al- currently being withheld under this tered, forged or counterfeited certifi- chapter, or (2) by a corporation, part- cate, memorandum, mark, or identification; (vii) has knowingly rep- nership, or other person having an offi- resented that any carcass, poultry, or cer, director, partner, or substantial product has been officially inspected investor from whom the benefits of and passed (by an authorized inspector) service under this chapter are cur- under this chapter, when it had not in rently being withheld and who has any fact been so inspected; (viii) has, with- authority with respect to the establish- in the previous ten years, been con- ment where service is or would be per- victed of any felony or more than one formed, or (b) in case the service is or misdemeanor under any law based upon would be performed with respect to any the acquiring, handling, or distributing poultry or product in which any cor- of adulterated, mislabeled, or decep- poration, partnership, or other person tively packaged food, or fraud in con- within (a)(1) of this section has a connection with transactions in food, or tract or other financial interest. any felony indicating a lack of the in- (2) Procedure. An application or re- tegrity needed for the conduct of oper- quest for service may be rejected, or ations affecting the public health; (ix) benefits of the service may be other- has in any manner not specified in this wise denied to or withdrawn by the paragraph violated subsection 203(h) of Secretary, as provided by this para- the Act: graph, after notice and opportunity for Provided, That paragraph (a)(1)(vi) of hearing before a proper official of the this section shall not be deemed to be Department. The Administrator may violated if the person in possession of reject an application or request for any item mentioned therein notifies service or deny or withdraw service the inspector without delay that he has under this paragraph without hearing, possession of such item and, in the case pending final determination of the of an official device, surrenders it to matter, when he determines that the the inspector, and, in the case of any public interest so requires. The oper- other item, surrenders it to the inspec- ator or applicant of such plant shall be tor or destroys it or brings it into com- notified of the Administrator’s deci- pliance with the regulations by obliter- sion to reject the application or re- ating or removing the violative fea- quest for service or to deny or with- tures under supervision of the inspec- draw such service, and the reasons

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therefor, in writing, in the manner pre- upon such oral or written notification, scribed in § 1.147(b) of the rules of prac- whichever is earlier, to the operator or tice (7 CFR 1.147(b)), or orally. The Ad- applicant of such plant. If such notifi- ministrator’s decision to reject an ap- cation is oral, the Administrator shall plication or request for service or to confirm such decision, and the reasons deny or withdraw the benefits of serv- therefor, in writing, as promptly as cir- ice under the Act shall be effective cumstances permit, and such written upon such oral or written notification, confirmation shall be served upon the whichever is earlier, to the operator or operator or applicant of such plant in applicant of such plant. If such notifi- the manner prescribed in § 1.147(b) of cation is oral, the Administrator shall the rules of practice (7 CFR 1.147(b)). confirm such decision, and the reasons (c) For miscellaneous reasons. An ap- therefor, in writing, as promptly as cir- plication or a request for service may cumstances permit, and such written be rejected, or the benefits of the serv- confirmation shall be served upon the ice may be otherwise denied to, or operator or applicant of such plant in withdrawn from, any person, without a the manner prescribed in § 1.147(b) of hearing, by the official in charge of the the rules of practice (7 CFR 1.147(b)). appropriate regional office, with the (b) For correctable cause—(1) Basis for concurrence of the Regional Director denial or withdrawal. An application or (1) for administrative reasons such as request for service may be rejected, or the nonavailability of personnel to per- the benefits of the service may be oth- form the service; (2) for the failure to erwise denied to, or withdrawn from, pay for service; (3) in case the applica- any person whose establishment does tion or request relates to birds or prod- not meet the requirements as to prem- ucts which are not eligible for service ises, facilities, and equipment, and the under this part 362; or (4) in case the operation thereof, prescribed in the person is a partnership, corporation, or regulations to prevent the distribution other person from whom the benefits of of adulterated poultry or poultry prod- the service are currently being with- ucts, or who has not received approval held under paragraph (a) of this sec- of labeling and containers to be used at tion. Notice of such rejection, denial, the establishment as required by the or withdrawal, and the reasons there- regulations. for, shall promptly be given to the per- (2) Procedure. An application or re- son involved. The operator or applicant quest for service may be rejected, or of such plant shall be notified of such benefits of the service may be other- decisions to reject an application or re- wise denied to or withdrawn by the quest for service or to deny or with- Secretary, as provided by this para- draw the benefits of the service, and graph, after notice and opportunity for the reasons therefor, in writing, in the hearing before a proper official of the manner prescribed in § 1.147(b) of the Department. The Administrator may rules of practice (7 CFR 1.147(b)), or reject an application or request for orally. Such decision shall be effective service or deny or withdraw service upon such oral or written notification, under this paragraph without hearing, whichever is earlier, to the operator or pending final determination of the applicant of such plant. If such notifi- matter, when he determines that the cation is oral, the person making such public interest so requires. The oper- decision shall confirm such decision, ator or applicant of such plant shall be and the reasons therefor, in writing, as notified of the Administrator’s deci- promptly as circumstances permit, and sion to reject the application or re- such written confirmation shall be quest for service or to deny or with- served upon the operator or applicant draw such service, and the reasons of such plant in the manner prescribed therefor, in writing, in the manner pre- in § 1.147(b) of the rules of practice (7 scribed in § 1.147(b) of the rules of prac- CFR 1.147(b)). tice (7 CFR 1.147(b)), or orally. The Ad- (d) Scope and applicability of rules of ministrator’s decision to reject an ap- practice. The rules of practice of the plication or request for service or to Department of Agriculture in subpart deny or withdraw the benefits of serv- H of part I, subtitle A, title 7 of the ice under the Act shall be effective Code of Federal Regulations, are the

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rules of practice applicable to adjudica- Subpart B—Administration; Application of tory, administrative proceedings under Inspection and Other Requirements the regulations in this part (9 CFR part 381.3 Administration. 362). 381.4 Inspection in accordance with methods [41 FR 23715, June 11, 1976, as amended at 43 prescribed or approved. FR 11148, Mar. 17, 1978] 381.5 Publications. 381.6 Establishments requiring inspection. § 362.5 Fees and charges. 381.7 Coverage of all poultry and poultry products processed in official establish- (a) Fees and charges for service under ments. the regulations in this part shall be paid by the applicant for the service in Subpart C—Exemptions accordance with this section, and, if re- 381.10 Exemptions for specified operations. quired by the Administrator, the fees 381.11 Exemptions based on religious die- and charges shall be paid in advance. tary laws. (b) The fees and charges provided for 381.12 Effect of religious dietary laws ex- in this section shall be paid by check, emptions on other persons. 381.13 Suspension or termination of exemp- draft, or money order payable to the tions. Treasurer of the United States and 381.14 Inspection concerning purportedly ex- shall be remitted promptly to the Ad- empted operations. ministrator upon furnishing to the ap- 381.15 Exemption from definition of ‘‘poul- plicant a statement as to the amount try product’’ of certain human food prod- due. ucts containing poultry. (c) The fees to be charged and col- Subpart D—Application for Inspection; lected for service under the regulations Grant or Refusal of Inspection in this part shall be at the rates specified in §§ 391.2, 391.3, and 391.4 respec- 381.16 How application shall be made. tively for base time; for overtime in- 381.17 Filing of application. cluding Saturdays, Sundays, and holi- 381.18 Authority of applicant. 381.20 Survey and grant of inspection. days; and for certain laboratory serv- 381.21 Refusal of inspection. ices which are not covered under the 381.22 Conditions for receiving inspection. base time, overtime, and/or holiday costs. Such fees shall cover the costs of Subpart E—Inauguration of Inspection; Of- the services and shall be charged for ficial Establishment Numbers; Separa- the time required to render such serv- tion of Establishments and Other Re- ice, including, but not limited to, the quirements; Withdrawal of Inspection time required for the travel of the in- 381.25 Official establishment numbers. spector or inspectors in connection 381.26 Separation of establishments. therewith during the regularly sched- 381.27 Inauguration of service; notification uled administrative workweek. concerning regulations; status of (d) Charges may also be made to uninspected poultry products. cover the cost of travel and other ex- 381.28 Report of violations. penses incurred by the Service in con- Subpart F—Assignment and Authorities of nection with the furnishing of the serv- Program Employees; Appeals ice. 381.30–381.31 [Reserved] [41 FR 23715, June 11, 1976, as amended at 53 381.32 Access to establishments. FR 13398, Apr. 22, 1988; 54 FR 6390, Feb. 10, 381.33 Identification. 1989] 381.34 Financial interest of inspectors. 381.35 Appeal inspections; how made.

PART 381—POULTRY PRODUCTS Subpart G—Facilities for Inspection; Over- INSPECTION REGULATIONS time and Holiday Service; Billing Es- tablishments Subpart A—Definitions 381.36 Facilities required. Sec. 381.37 Schedule of operations. 381.1 Definitions. 381.38 Overtime and holiday inspection service.

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381.39 Basis of billing for overtime and holi- 381.94 Contamination with Microorganisms; day services. process control verification criteria and testing; pathogen reduction standards. Subpart H [Reserved] Subpart L—Handling and Disposal of Con- Subpart I—Operating Procedures demned or Other Inedible Products at Official Establishments 381.65 Operations and procedures, generally. 381.66 Temperatures and chilling and freez- 381.95 Disposal of condemned poultry prod- ing procedures. ucts. 381.67 Young chicken and squab slaughter inspection rate maximums under tradi- Subpart M—Official Marks, Devices and tional inspection procedure. Certificates; Export Certificates; Certifi- 381.68 Maximum inspection rates—New tur- cation Procedures key inspection system. 381.96 Wording and form of the official inspection legend. Subpart J—Ante Mortem Inspection 381.97 [Reserved] 381.98 Official seal. 381.70 Ante mortem inspection; when re- 381.99 Official retention and rejection tags. quired; extent. 381.100 Official detention tag. 381.71 Condemnation on ante mortem in- 381.101 Official U.S. Condemned mark. spection. 381.102 [Reserved] 381.72 Segregation of suspects on ante 381.103 Official poultry condemnation cer- mortem inspection. tificates; issuance and form. 381.73 Quarantine of diseased poultry. 381.104 Official export certificates, marks 381.74 Poultry suspected of having biologi- and devices. cal residues. 381.105 Export certification; marking of 381.75 Poultry used for research. containers. 381.106 Form of official export certificate. 381.107 Special procedures as to certifi- Subpart K—Post Mortem Inspection; cation of poultry products for export to Disposition of Carcasses and Parts certain countries. 381.108 Official poultry inspection certifi- 381.76 Post-mortem inspection, when re- cates; issuance and disposition. quired; extent; traditional, Streamlined 381.109 Form of official poultry inspection Inspection System (SIS), New Line Speed certificate. (NELS) Inspection System and the New 381.110 Erasures or alterations made on cer- Turkey Inspection (NTI) System; rate of tificates. inspection. 381.111 Data to be entered in proper spaces. 381.77 Carcasses held for further examina- 381.112 Official mark for maintaining the tion. identity and integrity of samples. 381.78 Condemnation of carcasses and parts: separation of poultry suspected of con- Subpart N—Labeling and Containers taining biological residues. 381.115 Containers of inspected and passed 381.79 Passing of carcasses and parts. poultry products required to be labeled. 381.80 General; biological residues. 381.116 Wording on labels of immediate con- 381.81 Tuberculosis. tainers. 381.82 Diseases of the leukosis complex. 381.117 Name of product and other labeling. 381.83 Septicemia or toxemia. 381.118 Ingredients statement. 381.84 Airsacculitis. 381.119 Declaration of artificial flavoring or 381.85 Special diseases. coloring. 381.86 Inflammatory processes. 381.120 Antioxidants; chemical preserva- 381.87 Tumors. tives; and other additives. 381.121 Quantity of contents. 381.88 Parasites. 381.121a–381.121e [Reserved] 381.89 Bruises. 381.122 Identification of manufacturer, 381.90 Cadavers. packer or distributor. 381.91 Contamination. 381.123 Official inspection mark; official es- 381.92 Overscald. tablishment number. 381.93 Decomposition. 381.124 Dietary food claims. 381.125 Special handling label requirements. 381.126 Date of packing and date of processing; contents of cans. 381.127 Wording on labels of shipping containers.

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381.128 Labels in foreign languages. 381.172 Requirements for substitute stand- 381.129 False or misleading labeling or con- ardized poultry products named by use of tainers. an expressed nutrient content claim and 381.130 False or misleading labeling or con- a standardized term. tainers; orders to withhold from use. 381.173 Mechanically Separated (Kind of 381.131 Preparation of labeling or other de- Poultry). vices bearing official inspection marks 381.174 Limitations with respect to use of without advance approval prohibited; ex- Mechanically Separated (Kind of Poul- ceptions. try). 381.132 Labeling approval. 381.133 Generically approved labeling. Subpart Q—Records, Registration, and 381.134 Requirement of formulas. Reports 381.136 Affixing of official identification. 381.137 Evidence of labeling and devices ap- 381.175 Records required to be kept. proval. 381.176 Place of maintenance of records. 381.138 Unauthorized use or disposition of 381.177 Record retention period. approved labeling or devices. 381.178 Access to and inspection of records, 381.139 Removal of official identifications. facilities and inventory; copying and 381.140 Relabeling poultry products. sampling. 381.141–381.143 [Reserved] 381.179 Registration. 381.144 Packaging materials. 381.180 Information and reports required Subpart O—Entry of Articles Into Official Es- from official establishment operators. 381.181 Reports by consignees of allegedly tablishments; Processing Inspection adulterated or misbranded products; sale and Other Reinspections; Processing or transportation as violations. Requirements 381.182 Reports of inspection work. 381.146 Sampling at official establishments. 381.148 Processing and handling require- Subpart R—Cooperation With States and ments for frozen poultry products. Territories; Certification of State and 381.150 Requirements for the production of Territorial Programs as at Least Equal fully cooked poultry products and par- to Federal Program tially cooked poultry breakfast strips. 381.151 Adulteration of product by polluted 381.185 Assistance to State and Territorial water; procedure for handling. programs. 381.152 Preparation in an official establish- 381.186 Cooperation of States and other ju- ment of articles not for human food. risdictions in Federal programs. 381.153 [Reserved] 381.187 Cooperation of States for the interstate shipment of poultry products. Subpart P—Definitions and Standards of Identity or Composition Subpart S—Transportation; Exportation; or Sale of Poultry or Poultry Products 381.155 General. 381.156 Poultry meat content standards for 381.189 Provisions inapplicable to specimens certain poultry products. for laboratory examination, etc., or to 381.157 Canned boned poultry and baby or naturally inedible articles. geriatric food. 381.190 Transactions in slaughtered poultry 381.158 Poultry dinners (frozen) and pies. and other poultry products restricted; 381.159 Poultry rolls. vehicle sanitation requirements. 381.160 (Kind) burgers; (Kind) patties. 381.191 Distribution of inspected products to 381.161 ‘‘(Kind) A La Kiev.’’ small lot buyers. 381.162 ‘‘(Kind) steak or fillet.’’ 381.192 Penalties inapplicable to carriers. 381.163 ‘‘(Kind) baked’’ or ‘‘(Kind) roasted.’’ 381.193 Poultry carcasses, etc., not intended 381.164 ‘‘(Kind) barbecued.’’ for human food. 381.165 ‘‘(Kind) barbecued prepared with 381.194 Transportation and other trans- moist heat.’’ actions concerning dead, dying, disabled, 381.166 Breaded products. or diseased poultry, and parts of car- 381.167 Other poultry dishes and specialty casses of poultry that died otherwise items. than by slaughter. 381.168 Maximum percent of skin in certain poultry products. Subpart T—Imported Poultry Products 381.169 Ready-to-cook poultry products to which solutions are added. 381.195 Definitions; requirements for impor- 381.170 Standards for kinds and classes, and tation into the United States. for cuts of raw poultry. 381.196 Eligibility of foreign countries for 381.171 Definition and standard for ‘‘Turkey importation of poultry products into the Ham.’’ United States.

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381.197 Imported products; foreign inspec- 381.218 Criminal offenses. tion certificates required. 381.198 Importer to make application for in- Subpart V—Special Provisions for Des- spection of poultry products offered for ignated States and Territories; Criteria entry. and Procedure for Designating Estab- 381.199 Inspection of poultry products of- lishments With Operations Which fered for entry. Would Clearly Endanger the Public 381.200 Poultry products offered for entry, Health; Disposition of Poultry Products retention in customs custody; delivery Therein under bond; movement prior to inspection; handling; facilities and assistance. 381.220 Definition of ‘‘State’’. 381.201 Means of conveyance and equipment 381.221 Designation of States under para- used in handling poultry products offered graph 5(c) of the Act. 381.222 States designated under paragraph for entry to be maintained in sanitary 5(c) of the Act; application of regula- condition. tions. 381.202 Poultry products offered for entry; 381.223 Control and disposition of nonfeder- reporting of findings to customs; han- ally inspected poultry products in States dling of articles refused entry; appeals, designated under paragraph 5(c) of the how made; denaturing procedures. Act. 381.203 Products offered for entry; charges 381.224 Designation of States under section for storage, cartage, and labor with re- 11 of the Act; application of sections of spect to products which are refused the Act and the regulations. entry. 381.225 Criteria and procedure for desig- 381.204 Marking of poultry products offered nating establishments with operations for entry; official import inspection which would clearly endanger the public marks and devices. health; disposition of poultry products 381.205 Labeling of immediate containers of therein. poultry products offered for entry. Subpart X—Canning and Canned Products 381.206 Labeling of shipping containers of poultry products offered for entry. 381.300 Definitions. 381.207 Small importations for consignee’s 381.301 Containers and closures. personal use, display, or laboratory anal- 381.302 Thermal processing. ysis. 381.303 Critical factors and the application 381.208 Poultry products offered for entry of the process schedule. and entered to be handled and trans- 381.304 Operations in the thermal processing ported as domestic; entry into official es- area. tablishments; transportation. 381.305 Equipment and procedures for heat processing systems. 381.209 Returned United States inspected 381.306 Processing and production records. and marked poultry products: exemption. 381.307 Record review and maintenance. 381.308 Deviations in processing. Subpart U—Detention; Seizure and 381.309 Finished product inspection. Condemnation; Criminal Offenses 381.310 Personnel and training. 381.311 Recall procedure. 381.210 Poultry and other articles subject to administrative detention. Subpart Y—Nutrition Labeling 381.211 Method of detention; form of detention tag. 381.400 Nutrition labeling of poultry prod- 381.212 Notification of detention to the ucts. owner of the poultry or other article, or 381.401 Required nutrition labeling of the owner’s agent, and person having ground or chopped poultry products. custody. 381.402 Location of nutrition information. 381.403–381.407 [Reserved] 381.213 Notification of governmental au- 381.408 Labeling of poultry products with thorities having jurisdiction over article number of servings. detained; form of written notification. 381.409 Nutrition label content. 381.214 Movement of poultry or other article 381.410–381.411 [Reserved] detained; removal of official marks. 381.412 Reference amounts customarily con- 381.215 Poultry or other articles subject to sumed per eating occasion. judicial seizure and condemnation. 381.413 Nutrient content claims; general 381.216 Procedure for judicial seizure, con- principles. demnation, and disposition. 381.414–381.442 [Reserved] 381.217 Authority for condemnation or sei- 381.443 Significant participation for vol- zure under other provisions of law. untary nutrition labeling. 381.444 Identification of major cuts of poultry products. 423

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381.445 Guidelines for voluntary nutrition form shall also import the plural and labeling of single-ingredient, raw prod- the masculine form shall also import ucts. the feminine, and vice versa. 381.446–381.453 [Reserved] 381.454 Nutrient content claims for ‘‘good (b) For the purposes of such regula- source,’’ ‘‘high,’’ and ‘‘more’’. tions, unless otherwise required by the 381.455 [Reserved] context, the following terms shall be 381.456 Nutrient content claims for ‘‘light’’ construed, respectively, to mean: or ‘‘lite’’. Acceptable. ‘‘Acceptable’’ means suit- 381.457–381.459 [Reserved] 381.460 Nutrient content claims for calorie able for the purpose intended and ac- content. ceptable to the Administrator. 381.461 Nutrient content claims for the so- Act. ‘‘Act’’ means the Poultry Prod- dium content. ucts Inspection Act (71 Stat. 441, as 381.462 Nutrient content claims for fat, amended by the Wholesome Poultry fatty acids, and cholesterol content. Products Act, 82 Stat. 791; 21 U.S.C. 451 381.463 Nutrient content claims for ‘‘healthy.’’ et seq.). 381.464–381.468 [Reserved] Adulterated. ‘‘Adulterated’’ applies to 381.469 Labeling applications for nutrient any poultry product under one or more content claims. of the following circumstances: 381.470–381.479 [Reserved] (i) If it bears or contains any poi- 381.480 Label statements relating to usefulness in reducing or maintaining body sonous or deleterious substance which weight. may render it injurious to health; but 381.481–381.499 [Reserved] in case the substance is not an added 381.500 Exemption from nutrition labeling. substance, such article shall not be considered adulterated under this Subpart Z—Selected Establishments; Coop- clause if the quantity of such sub- erative Program for Interstate Shipment stance in or on such article does not of Poultry Products ordinarily render it injurious to health; 381.511 Definitions. (ii)(a) If it bears or contains (by rea- 381.512 Purpose. son of administration of any substance 381.513 Requirements for establishments; in- to the live poultry or otherwise) any eligible establishments. 381.514 State request for cooperative agree- added poisonous or added deleterious ment. substance (other than one which is a 381.515 Establishment selection; official pesticide chemical in or on a raw agri- number for selected establishments. cultural commodity; a food additive; or 381.516 Commencement of a cooperative a color additive) which may, in the interstate shipment program; inspection judgment of the Administrator, make by designated personnel and official such article unfit for human food; mark. 381.517 Federal oversight of a cooperative (b) If it is, in whole or part, a raw ag- interstate shipment program. ricultural commodity and such com- 381.518 Quarterly reports. modity bears or contains a pesticide 381.519 Enforcement authority. chemical which is unsafe within the 381.520 Deselection of ineligible establish- meaning of section 408 of the Federal ments. 381.521 Transition to official establishment. Food, Drug, and Cosmetic Act; 381.522 Transition grants. (c) If it bears or contains any food ad- 381.523 Separation of operations. ditive which is unsafe within the mean- 381.524 Voluntary withdrawal. ing of section 409 of the Federal Food, AUTHORITY: 7 U.S.C. 138f, 450; 21 U.S.C. 451– Drug, and Cosmetic Act; 470; 7 CFR 2.7, 2.18, 2.53. (d) If it bears or contains any color SOURCE: 37 FR 9706, May 16, 1972, unless additive which is unsafe within the otherwise noted. meaning of section 706 of the Federal Food, Drug, and Cosmetic Act: Subpart A—Definitions Provided, That an article which is not otherwise deemed adulterated under § 381.1 Definitions. paragraphs (b)(4)(ii) (b), (c), or (d) of (a) For the purposes of the regula- this section shall nevertheless be tions in this part, unless otherwise re- deemed adulterated if use of the pes- quired by the context, the singular ticide chemical, food additive, or color

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additive in or on such article is prohib- exemption, or other authorization ited by the regulations in this part in under the regulations. official establishments; Biological residue. ‘‘Biological Res- (iii) If it consists in whole or in part idue’’ means any substance, including of any filthy, putrid, or decomposed metabolites, remaining in poultry at substance or is for any other reason the time of slaughter or in any of its unsound, unhealthful, unwholesome, or tissues after slaughter, as the result of otherwise unfit for human food; treatment or exposure of the live poul- (iv) If it has been prepared, packed, try to a pesticide, organic compound, or held under insanitary conditions metallic or other inorganic compound, whereby it may have become contami- hormone, hormone-like substance, nated with filth, or whereby it may growth promoter, antibiotic, anthel- have been rendered injurious to health; mintic, tranquilizer, or other agent (v) If it is, in whole or in part, the that leaves a residue. product of any poultry which has died Capable of use as human food. The otherwise than by slaughter; term ‘‘capable of use as human food’’ applies to any carcass, or part or prod- (vi) If its container is composed, in uct of a carcass of any poultry, unless whole or in part, of any poisonous or it is denatured or otherwise identified deleterious substance which may as required by the regulations, or it is render the contents injurious to naturally inedible by humans. health; Carcass. This term means all parts, (vii) If it has been intentionally sub- including viscera, of any slaughtered jected to radiation, unless the use of poultry. the radiation was in conformity with a Commerce. ‘‘Commerce’’ means com- regulation or exemption in effect pur- merce between any State, any terri- suant to section 409 of the Federal tory, or the District of Columbia, and Food, Drug, and Cosmetic Act; or any place outside thereof; or within (viii) If any valuable constituent has any territory not organized with a leg- been in whole or in part omitted or ab- islative body, or the District of Colum- stracted therefrom; or if any substance bia. has been substituted, wholly or in part Consumer package. ‘‘Consumer pack- therefor; or if damage or inferiority age’’ means any container in which a has been concealed in any manner; or if poultry product is enclosed for the pur- any substance has been added thereto pose of display and sale to household or mixed or packed therewith so as to consumers. increase its bulk or weight, or reduce Container. The term ‘‘container’’ in- its quality or strength, or make it ap- cludes any box, can, tin, cloth, plastic, pear better or of greater value than it or any other receptacle, wrapper, or is. cover. Animal food. Any article intended for Edible. This term means that an arti- use as food for dogs, cats, or other ani- cle is intended for use as human food. mals, derived wholly, or in part, from Egg Products Inspection Act. ‘‘Egg carcasses or parts or products of the Products Inspection Act’’ means the carcass of poultry, except that the Act so entitled, approved December 29, term animal food as used herein does 1970 (84 Stat. 1620, 21 U.S.C. 1031 et not include (i) processed dry animal seq.). food or (ii) livestock or poultry feeds Federal Food, Drug, and Cosmetic Act. manufactured from processed poultry ‘‘Federal Food, Drug, and Cosmetic byproducts (such as poultry byproduct Act’’ means the Act so entitled, ap- meal, hydrolyzed poultry feathers, and proved June 25, 1938 (52 Stat. 1040), and hydrolyzed poultry byproducts aggre- acts amendatory thereof or supple- gate). mentary thereto (21 U.S.C. 301 et seq.). Animal food manufacturer. ‘‘Animal Federal Meat Inspection Act. ‘‘Federal Food Manufacturer’’ means any person Meat Inspection Act’’ means the Act so engaged in the business of manufac- entitled, approved March 4, 1907, 34 turing or processing animal food. Stat. 1260, as amended by the Whole- Applicant. ‘‘Applicant’’ means any some Meat Act, 81 Stat. 584 (21 U.S.C. person who requests inspection service, 601 et seq.).

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Free from protruding pinfeathers. Misbranded. This term applies to any ‘‘Free from protruding pinfeathers’’ poultry product under one or more of means that the carcass is free from the following circumstances: protruding pinfeathers which are visi- (i) If its labeling is false or mis- ble to an inspector during an examina- leading in any particular; tion of the carcass at normal operating (ii) If it is offered for sale under the speeds. However, a carcass may be con- name of another food; sidered as being free from protruding (iii) If it is an imitation of another pinfeathers if it has a generally clean food, unless its label bears, in type of appearance (especially on the breast), uniform size and prominence, the word and if not more than an occasional pro- ‘‘imitation’’ and immediately there- truding pinfeather is in evidence dur- after, the name of the food imitated; ing a more careful examination of the (iv) If its container is so made, carcass. formed, or filled as to be misleading; (v) If in a package or other container, Giblets. ‘‘Giblets’’ means the liver unless it bears a label showing: from which the bile sac has been re- (a) The name and place of business of moved, the heart from which the peri- the manufacturer, packer, or dis- cardial sac has been removed, and the tributor; and gizzard from which the lining and con- (b) An accurate statement of the tents have been removed: Provided, quantity of the contents in terms of That each such organ has been prop- weight, measure, or numerical count; erly trimmed and washed. except as otherwise provided in Immediate container. ‘‘Immediate con- § 381.121(a) with respect to the quantity tainer’’ includes any consumer pack- of contents; age; or any other container in which (vi) If any word, statement, or other poultry products, not consumer pack- information required by or under au- aged, are packed. thority of the Act to appear on the Inedible. This term means any car- label or other labeling is not promi- cass or any part of a carcass that is ei- nently placed thereon with such con- ther naturally inedible by humans or is spicuousness (as compared with other rendered unfit for human food by rea- words, statements, designs, or devices, son of adulteration or denaturing. in the labeling) and in such terms as to Inspected for wholesomeness. This term render it likely to be read and under- means that the poultry product so stood by the ordinary individual under identified has been inspected and was customary conditions of purchase and found at the time of such inspection to use; be not adulterated. (vii) If it purports to be or is rep- Inspection. ‘‘Inspection’’ means any resented as a food for which a definition and standard of identity or com- inspection required by the regulations position is prescribed by the regula- to determine whether any poultry or tions in subpart P of this part unless: poultry products comply with the re- (a) It conforms to such definition and quirements of the Act and the regula- standard, and tions. (b) Its label bears the name of the Label. This term applies to any dis- food specified in the definition and play of written, printed, or graphic standard, and insofar as may be re- matter upon any article or the imme- quired by such regulations, the com- diate container (not including package mon names of optional ingredients liners) of any article. (other than spices, flavoring, and color- Labeling. This term applies to all la- ing) present in such food. bels and other written, printed, or (viii) If it purports to be or is rep- graphic matter (i) upon any article or resented as a food for which a standard any of its containers or wrappers, or or standards of fill of container have (ii) accompanying such article. been prescribed by regulations of the

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Secretary, 2 and falls below the stand- part M of this part for use in applying ard of fill of container applicable there- any official mark. to, unless its label bears, in such man- Official establishment. ‘‘Official estab- ner and form as such regulations speci- lishment’’ means any establishment as fy, a statement that it falls below such determined by the Administrator at standard; which inspection of the slaughter of (ix) If it is not subject to the provi- poultry, or the processing of poultry sions of paragraph (b)(vii) of this sec- products, is maintained pursuant to tion, unless its label bears: the regulations. (a) The common or usual name of the Official inspection legend. This term food, if any there be, and means the official inspection mark pre- (b) In case it is fabricated from two scribed in § 381.96 or the official poultry or more ingredients, the common or identification mark prescribed in usual name of each ingredient, except § 381.97, showing that an article was in- as otherwise provided in § 381.118(c); spected for wholesomeness and passed (x) If it purports to be or is rep- in accordance with the Act. resented for special dietary uses, unless Official mark. This term means any the label bears such information con- symbol prescribed in subpart M of this cerning its vitamin, mineral, and other part to identify the status of any arti- dietary properties as is required by cle or poultry under the Act. § 381.124; Packaging material. Any cloth, paper, (xi) If it bears or contains any artifi- plastic, metal, or other material used cial flavoring, artificial coloring, or to form a container, wrapper, label, or chemical preservative, unless it bears a cover for poultry products. label stating that fact; except as other- Pesticide chemical, food additive, color wise provided in § 381.119, or additive, raw agricultural commodity. (xii) If it fails to bear, directly there- These terms shall have the same mean- on or on its containers, when required ings for the purposes of the Act and the by § 381.123, the official inspection leg- regulations as under the Federal Food, end and the official establishment Drug, and Cosmetic Act. number of the establishment where the Poultry. ‘‘Poultry’’ means any domes- product was processed; and unre- ticated bird (chickens, turkeys, ducks, stricted by any of the foregoing; such geese, guineas, ratites, or squabs, also other information as the Adminis- termed young pigeons from one to trator may require in the regulations about thirty days of age), whether live to assure that it will not have false or or dead. misleading labeling and that the public Poultry product. (i) This term means will be informed of the manner of han- any poultry carcass or part thereof; or dling required to maintain the article any product which is made wholly or in in a wholesome condition. part from any poultry carcass or part Nonfood compounds. Any substance thereof, excepting those exempted from proposed for use in official establish- definition as a poultry product in ments, the intended use of which will § 381.15. Except where the context re- not result, directly or indirectly, in the quires otherwise (e.g., in paragraph substance becoming a component or (b)(42) of this section), this term is lim- otherwise affecting the characteristics ited to articles capable of use as human of poultry or poultry products, exclud- food. ing labeling and packaging materials (ii) Poultry food product. This term as covered in subpart N of this part. means any product capable of use as Official certificate. This term means human food which is made in part from any certificate prescribed in subpart M any poultry carcass or part thereof, ex- of this part relating to poultry or poul- cepting those exempted from definition try products. as a poultry product in § 381.15. Official device. This term means any Poultry products broker. ‘‘Poultry label or other device prescribed in sub- products broker’’ means any person engaged in the business of buying or sell- 2 No such standards are currently in effect. ing poultry products on commission, or However, § 381.129 prohibits the use of false or otherwise negotiating purchases or misleading containers. sales of such articles other than for his

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own account or as an employee of an- State. Except as otherwise provided in other person. § 381.220 ‘‘State’’ means any State of Process. Process used as a verb means the United States and the Common- to conduct any operation or combina- wealth of Puerto Rico. tion of operations, whereby poultry is Supervision. This term means the con- slaughtered, eviscerated, canned, salt- trols, as prescribed in instructions to ed, stuffed, rendered, boned, cut up, or Inspection Service employees, to be ex- otherwise manufactured or processed. ercised by them over particular oper- The term ‘‘process’’ does not refer to ations to insure that such operations freezing of poultry products, except are conducted in compliance with the when freezing is incidental to oper- Act and the regulations in this part. ations otherwise classed as ‘‘processing’’ under this paragraph. Territory. The term ‘‘territory’’ Process authority. A person or organi- means Guam, the Virgin Islands of the zation with expert knowledge in poul- United States, American Samoa, and try production process control and rel- any other territory or possession of the evant regulations. United States, excluding the Canal Process schedule. A written descrip- Zone. tion of processing procedures, con- United States. This term means the sisting of any number of specific, dis- States, the District of Columbia, and tinct, and ordered operations directly the territories of the United States. under control of the establishment em- U.S. Condemned. This term means ployed in the manufacture of a specific that the poultry carcass, or part or product, including the control, moni- product of a poultry carcass, so identi- toring, verification, validation, and fied was inspected and found to be corrective action activities associated adulterated and is condemned. with production. U.S. Detained. This term is applicable Ready-to-cook poultry. ‘‘Ready-to- to poultry, poultry products, and other cook poultry’’ means any slaughtered articles which are held in official cus- poultry free from protruding pin- tody in accordance with section 19 of feathers and vestigial feathers (hair or the Act and § 381.210, pending disposal down), from which the head, feet, crop, as provided in said section 19. oil gland, trachea, esophagus, entrails, and lungs have been removed, and from U.S. Refused Entry. This term means which the mature reproductive organs that the slaughtered poultry or other and kidneys may have been removed, poultry product so identified was pre- and with or without the giblets, and sented for inspection for entry into the which is suitable for cooking without United States and was found not to need of further processing. Ready-to- comply with the requirements of the cook poultry also means any cut-up or Act. disjointed portion of poultry or other U.S. Rejected. This term means that parts of poultry, such as reproductive the equipment or facility so identified organs, head, or feet that are suitable is prohibited from being used in the for cooking without need of further processing of any poultry or poultry processing. product until such equipment or facil- Regulations. ‘‘Regulations’’ means the ity is found by an inspector to be sani- provisions of this entire part. tary and otherwise eligible for use Renderer. ‘‘Renderer’’ means any per- under the regulations. son engaged in the business of ren- U.S. Retained. This term means that dering carcasses, or parts or products the poultry or carcass, or part or prod- of the carcasses, of poultry, except ren- uct of a carcass, of poultry so identi- dering conducted under inspection or fied is held at an official establishment exemption pursuant to the regulations. Shipping container. ‘‘Shipping con- by the inspection service for further tainer’’ means any container used or determination as to its disposal. intended for use in packaging the prod- (c) For the purposes of the standard uct packed in an immediate container. for cooked, smoked sausage (§ 319.180 of Slaughter. ‘‘Slaughter’’ means the act this chapter), the term ‘‘poultry by- of killing poultry for human food. product’’ means the skin, fat, gizzard,

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heart, or liver, or any combination ministrator shall identify establish- thereof, of any poultry. ments for review, and the frequency and the manner of inspection by In- [37 FR 9706; May 16, 1972, as amended at 39 FR 4568, Feb. 5, 1974; 40 FR 42338, Sept. 12, spection Service employees shall be de- 1975; 48 FR 6091, Feb. 10, 1983; 49 FR 2236, Jan. termined on the basis of the results of 19, 1984; 49 FR 3643, Jan. 30, 1984; 49 FR 47478, those reviews and be otherwise in ac- Dec. 5, 1984; 51 FR 37709, Oct. 24, 1986; 64 FR cordance with this section. 745, Jan. 6, 1999; 64 FR 56416, Oct. 20, 1999; 66 (d) The determinations referred to in FR 1770, Jan. 9, 2001; 66 FR 22905, May 7, 2001; paragraph (c) of this section shall be 67 FR 13258, Mar. 22, 2002; 69 FR 255, Jan. 5, made by the Inspection Service and 2004] shall reflect evaluations of the performance and the characteristics of Subpart B—Administration; Appli- such establishments. cation of Inspection and (1) In assessing the performance of an Other Requirements establishment, the following factors are appropriate for consideration: § 381.3 Administration. (i) The history of compliance with (a) [Reserved] applicable regulatory requirements by (b) The Administrator may in spe- the person operating such establish- cific classes of cases waive for limited ment or by anyone responsibly con- periods any provisions of the regula- nected with the business operating tions in order to permit appropriate such establishment, as ‘‘responsibly and necessary action in the event of a connected’’ is defined in section 18(a) of public health emergency or to permit the Act, experimentation so that new proce- (ii) The competence of the person op- dures, equipment, and processing tech- erating such establishment, as indi- niques may be tested to facilitate defi- cated by: nite improvements: Provided, That such (A) Knowledge of appropriate manu- waivers of the provisions of the regula- facturing practices and applicable reg- tions are not in conflict with the pur- ulatory requirements, poses or provisions of the Act. (B) Demonstrated ability to apply (c) Pursuant to section 6 of the Act, such knowledge in a timely and con- the Administrator believes that, in es- sistent manner, and tablishments processing poultry prod- (C) Commitment to correcting defi- ucts at which inspection under the Act ciencies noted by Inspection Service and regulations is required, the fre- employees and otherwise assuring com- quency with which and the manner in pliance with applicable regulatory re- which poultry products made from quirements, and poultry previously slaughtered and (iii) The procedures used in such es- eviscerated in official establishments tablishment to control the production are reinspected by Inspection Service process, environment, and resulting employees should be based on consider- product in order to assure and monitor ations relevant to effective regulation compliance with the requirements of of poultry products and protection of the Act and the rules and regulations the health and welfare of consumers. In promulgated thereunder. order to test procedures for use in (2) In assessing the characteristics of making such determinations and, in an establishment, the following factors particular, for determining whether are appropriate for consideration: and, if so, to what extent the intensity (i) The complexity of the processing of inspection coverage exceeds that operation(s) conducted at such estab- which should be deemed necessary pur- lishment, suant to section 6 of the Act, the Ad- (ii) The frequency with which each ministrator is initiating experimen- such operation is conducted at such es- tation of a new system of inspection tablishment, for reviewing the performance of estab- (iii) The volume of product resulting lishments and for designing the super- from each such operation at such es- vision and other conditions and meth- tablishment, ods of inspection coverage. For the pe- (iv) Whether and to what extent riod of such experimentation, the Ad- slaughter and evisceration operations

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also are conducted at such establish- the Administrator will waive such pro- ment, visions for the period of experimen- (v) What, if any, food products not tation, in accordance with paragraph regulated under this Act or the Federal (b) of this section. Meat Inspection Act also are processed at such establishment, and [37 FR 9706, May 16, 1972, as amended at 52 FR 10033, Mar. 30, 1987; 69 FR 255, Jan. 5, 2004] (vi) The size of such establishment. (e)(1) For the period of experimen- § 381.4 Inspection in accordance with tation described in paragraph (c) of methods prescribed or approved. this section, the frequency of inspection by Inspection Service employees Inspection of poultry products shall of operations other than slaughter and be rendered pursuant to the regula- evisceration may be reduced in an es- tions and under such conditions and in tablishment in which the procedures accordance with such methods as may referred to therein are being tested if be prescribed or approved by the Ad- and only if the evaluation of the per- ministrator. formance of such establishment de- § 381.5 Publications. scribed in paragraph (d)(1) indicates that there are: Publications under the Act and the (i) No instances, documented in regulations shall be made in the FED- records compiled no earlier than 10 ERAL REGISTER and in such other media years before, of substantial and recent as the Administrator may designate. noncompliance with applicable regulatory requirements (taking into ac- § 381.6 Establishments requiring in- count both the nature and frequency of spection. any such noncompliance), and Inspection under the regulations is (ii) The competence and control pro- required at: cedures needed to assure and monitor (a) Every establishment, except as compliance with applicable regulatory provided in § 381.10 (a) and (b) or § 381.11, requirements. in which any poultry is slaughtered for (2)(i) The frequency of Federal in- transportation or sale in commerce, or spection and other conditions and in which any poultry products are methods of inspection coverage in any wholly or in part, processed for trans- establishment in which the frequency portation or sale in commerce, as arti- of Federal inspection is reduced shall cles intended for use as human food; be based on: (b) Every establishment, except as (A) The evaluation of the character- provided in § 381.10 (a) and (b), (c), or istics of such establishment described (d), or § 381.11, within any State or or- in paragraph (d)(2) of this section, 1 ganized territory which is designated (B) The significance of potential pub- in § 381.221 pursuant to section 5(c) of lic health consequences of noncompli- the Act, at which any poultry is ance, and slaughtered or any poultry products (C) The availability of Inspection are processed, for use as human food Service employees. solely for distribution within such ju- (ii) To the extent that frequency of risdiction; and inspection or other conditions and (c) Except as provided in § 381.10 (a) methods of inspection coverage are and (b), or (c), or § 381.11, every estab- identified as conflicting with provi- lishment designated by the Adminis- sions of the regulations in this part, trator pursuant to section 5(c) of the Act as one producing adulterated poul- 1 These evaluations will be based upon try products which would clearly en- guidelines developed by FSIS and the com- danger the public health. plexity categorization in FSIS Directive 1030.2 (Documentation of Processing and § 381.7 Coverage of all poultry and Combination Assignments, 4/22/85). The poultry products processed in offi- guidelines and Directive will be available for cial establishments. public inspection and copying in the Policy Office, Room 3168, South Agriculture Build- All poultry and poultry products ing, 14th Street and Independence Avenue, processed in an official establishment SW., Washington, DC. shall be inspected, handled, processed,

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marked, and labeled as required by the bers of his household and his non- regulations. paying guests and employees: Provided, That in lieu of complying with all the Subpart C—Exemptions adulteration and misbranding provisions of the Act, such poultry is § 381.10 Exemptions for specified oper- healthy and is slaughtered and proc- ations. essed under such sanitary standards, (a) The requirements of the Act and practices, and procedures as result in the regulations for inspection of the the preparation of poultry products processing of poultry and poultry prod- that are sound, clean, and fit for ucts shall not apply to: human food, and the shipping con- (1) Any retail dealer with respect to tainers of such poultry products bear poultry products sold in commerce di- the producer’s name and address and rectly to consumers in an individual the statement ‘‘Exempted—P.L. 90– retail store, if the only processing op- 492.’’ eration performed by such retail dealer (4) The custom slaughter by any per- is the cutting up of poultry products on son of poultry delivered by the owner the premises where such sales to con- thereof for such slaughter, and the sumers are made: Provided, That such processing by such slaughterer and operation is conducted under such sani- transportation in commerce of the tary standards, practices, and proce- poultry products exclusively for use, in dures as result in the preparation of the household of such owner, by him poultry products that are not adulter- and members of his household and his ated: And provided further, That the nonpaying guests and the employees: poultry products sold in commerce are Provided, That such custom slaughterer derived from poultry inspected and does not engage in the business of buy- passed under the Act and such poultry ing or selling any poultry products ca- products are not adulterated or mis- pable of use as human food: And pro- branded at the time of sale (except that vided further, That in lieu of complying the official inspection legend shall not with all the adulteration and mis- be used). (For the purposes of this sub- branding provisions of the Act, such paragraph, a retail dealer is any person poultry is healthy and is slaughtered who sells poultry products directly to and processed under such sanitary consumers as defined in paragraph standards, practices, and procedures as (d)(2)(vi) of this section and whose sales result in the preparation of poultry of poultry products to household con- products that are sound, clean and fit sumers constitute, in terms of dollar for human food, and the shipping con- value, at least 75 percent of his total tainers of such poultry products bear sales of poultry products.) the owner’s name and address and the (2) The slaughter of poultry, and the statement ‘‘Exempted—P.L. 90–492.’’ processing of poultry products, by any (5) The slaughtering of sound and person in any territory not organized healthy poultry and processing of poul- with a legislative body, solely for dis- try products therefrom in any State or tribution within such territory: Pro- territory or the District of Columbia vided, That such poultry is sound and by any poultry producer on his own healthy and is slaughtered under such premises with respect to poultry raised sanitary standards, practices, and pro- on his premises, and the distribution cedures as result in the preparation of by any person solely within such juris- poultry products that are not adulter- diction of the poultry products derived ated: And provided further, That the from such operations: Provided, That (i) poultry products are not adulterated or in lieu of complying with all the adul- misbranded when so distributed (except teration provisions of the Act, such that the official inspection legend shall poultry is slaughtered and otherwise not be used). processed and handled under such sani- (3) The slaughtering by any person of tary standards, practices, and proce- poultry of his own raising, and the dures as result in the preparation of processing by him and transportation poultry products that are sound, clean, in commerce of the poultry products and fit for human food when so distrib- exclusively for use by him and mem- uted; (ii) such poultry products when

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so distributed, bear (in lieu of labeling for distribution as carcasses or parts that would otherwise be required) the thereof solely for distribution within producer’s name and address and the such jurisdiction; Provided, That (i) statement ‘‘Exempted—P.L. 90–492’’ such poultry is sound and healthy when and such poultry products are not oth- slaughtered and is slaughtered and/or erwise misbranded; (iii) such producer cut up and handled under such sanitary and distributor do not engage in the standards, practices and procedures as current calendar year in the business result in the preparation of poultry of buying or selling any poultry or products that are not adulterated when poultry products other than as speci- so distributed; and (ii) when so distrib- fied in this paragraph (a) (5) or (6) of uted, such poultry products are not this section; and (iv) neither such pro- misbranded (except that the official in- ducer or distributor slaughters or proc- spection legend shall not be used). esses the products of more poultry (b) No person qualifies for any ex- than allowed by paragraph (b) of this emption specified in paragraph (a)(5), section. (6), or (7) of this section if, in the cur- (6) The slaughtering of sound and rent calendar year, such person: healthy poultry or the processing of (1) Slaughters or processes the prod- poultry products of such poultry in any ucts of more than 20,000 poultry, or State or territory or the District of Co- (2) Slaughters or processes poultry lumbia by any poultry producer or products at a facility used for slaugh- other person for distribution by him tering or processing poultry products solely within such jurisdiction directly by any other person, except when the to household consumers, restaurants, Administrator grants such exemption hotels, and boardinghouses, for use in after determining, upon review of a their own dining rooms, or in the prep- person’s application, that such an ex- aration of meals for sales direct to con- emption will not impair effectuating sumers: Provided, That (i) in lieu of the purposes of the Act. complying with all the adulteration (c) The provisions of the Act and the provisions of the Act, such poultry is regulations do not apply to any poultry slaughtered and otherwise processed producer with respect to poultry, of his and handled under such sanitary stand- own raising on his own farm, which he ards, practices, and procedures as re- slaughters if: sult in the preparation of poultry prod- (1) Such producer slaughters not ucts that are sound, clean, and fit for more than 1,000 poultry during the cal- human food when distributed by such endar year for which this exemption is processor; (ii) such poultry products being determined; when so distributed bear (in lieu of la- (2) Such poultry producer does not beling that would otherwise be re- engage in buying or selling poultry quired) the processor’s name and ad- products other than those produced dress and the statement ‘‘Exempted— from poultry raised on his own farm; P.L. 90–492’’ and such poultry products and are not otherwise misbranded; (iii) (3) None of such poultry moves in such processor does not engage in the ‘‘commerce’’ (as defined in § 381.1). current calendar year in the business (d)(1) The requirements of the Act of buying or selling any poultry or and the regulations for inspection of poultry products other than as speci- the processing of poultry and poultry fied in this paragraph (a) (6) or (5) of products do not apply to operations of this section; and (iv) such processor types traditionally and usually con- does not exceed the volume limitation ducted at retail stores and restaurants, prescribed in paragraph (b) of this sec- when conducted at any retail store or tion. restaurant or similar-retail-type estab- (7) The operations and products of lishment for sale in normal retail small enterprises (including poultry quantities or service of such articles to producers) not exempted under para- consumers at such establishments. graphs (a) (1) through (6) of this section (2) For the purposes of paragraph that are engaged in any State or terri- (d)(1) of this section: tory or the District of Columbia in (i) Operations of types traditionally slaughtering and/or cutting up poultry and usually conducted at retail stores

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and restaurants include any processing tity as defined in paragraph (d)(2)(ii) of of poultry products except canning of this section; and poultry products and except slaugh- (e) The processing of poultry prod- tering of poultry unless such slaugh- ucts for sale is limited to traditional tering is conducted at a retail store and usual operations as defined in with respect to live poultry purchased paragraph (d)(2)(i) of this section. by the consumer at the retail store and (iv) Restaurants. (a) A restaurant is processed by the retail store operator any establishment where: in accordance with the consumer’s in- (1) Poultry products are processed structions. only for sale or service in meals or as (ii) A normal retail quantity is any entrees directly to individual con- quantity of a poultry product pur- sumers at such establishments; chased by a household consumer from a (2) Only federally inspected and retail supplier that in the aggregate passed, or exempted (or, as provided in does not exceed 75 pounds. A normal re- § 381.223, State or local agency in- tail quantity sold by a retail supplier spected and passed or exempted) poul- to other than a household consumer is try products are handled or used in the any quantity that in the aggregate preparation of any poultry products; does not exceed 150 pounds. (3) No sale of poultry products is (iii) A retail store is any place of made in excess of a normal retail quan- business where: tity as defined in paragraph (d)(2)(ii) of (a) The sales of poultry products are this section; and made to consumers only; (4) The processing of poultry prod- (b) At least 75 percent, in terms of ucts is limited to traditional and usual dollar value, of total sales of product operations as defined in paragraph represents sales to household con- (d)(2)(i) of this section. sumers and the total dollar value of sales of product to consumers other (b) The definition of a restaurant in- than household consumers does not ex- cludes a caterer which delivers or ceed the dollar limitation per calendar serves product in meals, or as entrees, year set by the Administrator. This only to individual consumers and oth- dollar limitation is a figure which will erwise meets the requirements of this automatically be adjusted during the paragraph. first quarter of each calendar year, up- (c) For purposes of this paragraph, ward or downward, whenever the Con- operations conducted as a restaurant sumer Price Index, published by the central kitchen facility shall be consid- Bureau of Labor Statistics, Depart- ered as being conducted at a restaurant ment of Labor, indicates a change in if the restaurant central kitchen pre- the price of this same volume of prod- pares poultry products that are ready uct which exceeds $500. Notice of the to eat when they leave such facility adjusted dollar limitation will be pub- (i.e., no further cooking or other prepa- lished in the FEDERAL REGISTER. 1 ration is needed, except that they may (c) Only federally or State inspected be reheated prior to serving if chilled and passed, or exempted (or, as pro- during transportation), transported divided in § 381.223, State or local agency rectly to a receiving restaurant by its inspected and passed or exempted) own employees, without intervening poultry products are handled or used in transfer or storage, maintained in a the preparation of any poultry prod- safe, unadulterated condition during ucts; transportation, and served in meals or (d) No sale of poultry products is as entrees only to customers at res- made in excess of a normal retail quan- taurants, or through vending machines, owned or operated by the same person that owns or operates such fa- 1 The dollar limitation currently in effect cility, and which otherwise meets the may be obtained by contacting Director, requirement of this paragraph: Pro- Slaughter Inspection Standards and Proce- dures Division, Technical Services, Food vided, That the requirements of Safety and Inspection Service, U.S. Depart- §§ 381.175 through 381.178 of this sub- ment of Agriculture, Washington, DC 20250 chapter apply to such facility. Provided (202) 447–3219. further, That the exempted facility

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may be subject to inspection require- ministrator shall order the operator to ments under the Act for as long as the maintain complete, accurate, and leg- Administrator deems necessary if the ible records of his total monthly pur- Administrator determines that the chases and of his total monthly sales of sanitary conditions or practices of the poultry and poultry products. Such facility or the processing procedures or records shall separately show total methods at the facility are such that sales to household consumers and total any of its poultry products are ren- sales to other consumers, and shall be dered adulterated. When the Adminis- maintained for the period prescribed in trator has made such determination § 381.177. If the operator maintains cop- and subjected a restaurant central ies of bills of lading, receiving and kitchen facility to such inspection re- shipping invoices, warehouse receipts, quirements, the operator of such facil- or similar documents which give the ity shall be afforded an opportunity to information required herein, additional dispute the Administrator’s determina- records are not required by this sub- tion in a hearing pursuant to rules of paragraph. practice which will be adopted for this (4) The adulteration and misbranding proceeding. provisions of the Act and the regula- (v) A similar retail-type establish- tions other than the requirement of the ment is any establishment which is a official inspection legend, apply to ar- combination retail store and res- ticles which are exempted from inspec- taurant; any delicatessen which meets tion under this paragraph (d). the requirements for a retail store or (e)(1) The requirements of the Act restaurant as prescribed in paragraph and the regulations in this subchapter (d)(2) (iii) or (iv) of this section; or for inspection of the preparation of other establishment as determined by products do not apply to poultry pizzas the Administrator in specific cases. containing poultry product ingredients (vi) A consumer is any household which were prepared, inspected, and consumer, hotel, or restaurant, or passed in a cured or cooked form as similar institution as determined by ready-to-eat (i.e., no further cooking or the Administrator in specific cases. other preparation is needed) in compli- (3) Whenever any complaint is re- ance with the requirements of the Act ceived by the Administrator from any and these regulations; and the poultry person alleging that any retail estab- pizzas are to be served in public or pri- lishment or restaurant claiming ex- vate nonprofit institutions, provided emption under this paragraph (d) in that the poultry pizzas are ready to eat any designated State or organized ter- (i.e., no further cooking or other prepa- ritory listed in § 381.221 that is also ration is needed, except that they may identified in § 381.224 as a jurisdiction be reheated prior to serving if chilled that does not have or is not exercising during transportation), transported di- adequate authority with respect to rec- rectly to the receiving institution by ordkeeping requirements, has been op- employees of the preparing firm, re- erated in violation of the conditions ceiving institution, or a food service prescribed in this paragraph (d) for management company contracted to such exemption, and the Adminis- conduct food service at the public or trator, upon investigation of the com- private nonprofit institution, without plaint, has reason to believe that any intervening transfer or storage. such violation has occurred, he shall so (2) The definitions at Chapter 1, 1–102, notify the operator of the retail estab- except 1–102(z) and the provisions of lishment or restaurant and afford him Chapters 2 through 8, except sections 2– reasonable opportunity to present his 102 (a) and (b), 2–302(d), 2–403(a), 2– views informally with respect to the 403(c), 2–404, 2–405, 2–407, 2–502 through matter. Thereafter, if the Adminis- 2–506, 2–508, 2–509, 4–105, 4–201(c), 4–208, trator determines that such a violation 5–101(a), 5–103, 5–104, 5–202(c), 5–203, and has occurred, and that a requirement 6–105, Part IV, of the Food and Drug that the operator keep records con- Administration’s Food Service Sanita- cerning the operations of the retail es- tion Manual (1976 Recommendations), tablishment or restaurant would effec- DHEW Publication No. (FDA) 78–2081, tuate the purposes of the Act, the Ad- which is incorporated by reference,

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shall apply to the facilities and oper- ing and sanitizing shall be conducted in ations of businesses claiming this ex- the following sequence: emption. (These materials are incor- (1) Sinks shall be cleaned prior to porated as they exist on the date of ap- use. proval. This incorporation by reference (2) Equipment and utensils shall be was approved by the Director of the thoroughly washed in the first com- Federal Register in accordance with 5 partment with a hot detergent solution U.S.C. 552(a) and 1 CFR part 51. Copies that is kept clean. may be purchased from the Super- (3) Equipment and utensils shall be intendent of Documents, U.S. Govern- rinsed free of detergent and abrasives ment Printing Office, Washington, DC with clean water in the second com- 20402. It is also available for inspection partment. at the FSIS Hearing Clerk, room 3171, (4) Equipment and utensils shall be South Building, Food Safety and In- sanitized in the third compartment ac- spection Service, U.S. Department of cording to one of the methods pre- Agriculture, Washington, DC 20250 or scribed in paragraph (e)(3)(i)(E) (1) at the National Archives and Records through (4) of this section. Administration (NARA). For informa- (E) The food-contact surfaces of all tion on the availability of this mate- equipment and utensils shall be sani- rial at NARA, call 202–741–6030, or go tized by: to: http://www.archives.gov/ (1) Immersion for at least 1⁄2 minute federallregister/ in clean, hot water at a temperature of codeloflfederallregulations/ at least 170 °F; or ibrllocations.html. (2) Immersion for at least 1 minute in (3) Facilities and operations of busi- a clean solution containing at least 50 nesses claiming this exemption shall parts per million of available chlorine also conform to the following require- as a hypochlorite and at a temperature ° ments: of at least 75 F; or (3) Immersion for at least 1 minute in (i) Manual cleaning and sanitizing. (A) a clean solution containing at least 12.5 For manual washing, rinsing and sani- parts per million of available iodine tizing of utensils and equipment, a sink and having a pH not higher than 5.0 with not fewer than three compart- and at a temperature of at least 75 °F; ments shall be provided and used. Sink or compartments shall be large enough to (4) Immersion in a clean solution permit the accommodation of the containing any other chemical sani- equipment and utensils, and each com- tizing agent allowed under 21 CFR partment of the sink shall be supplied 178.1010 that will provide the equiva- with hot and cold potable running lent bactericidal effect of a solution water. Fixed equipment and utensils containing at least 50 parts per million and equipment too large to be cleaned of available chlorine as a hypochlorite in sink compartments shall be washed at a temperature of at least 75 °F for 1 manually or cleaned through pressure minute; or spray methods. (5) Treatment with steam free from (B) Drain boards or easily movable materials or additives other than those dish tables of adequate size shall be specified in 21 CFR 173.310 in the case provided for proper handling of soiled of equipment too large to sanitize by utensils prior to washing and for immersion, but in which steam can be cleaned utensils following sanitizing confined; or and shall be located so as not to inter- (6) Rinsing, spraying, or swabbing fere with the proper use of the dish- with a chemical sanitizing solution of washing facilities. at least twice the strength required for (C) Equipment and utensils shall be that particular sanitizing solution preflushed or prescraped and, when under paragraph (e)(3)(i)(E)(4) of this necessary, presoaked to remove gross section in the case of equipment too food particles and soil. large to sanitize by immersion. (D) Except for fixed equipment and (F) When hot water is used for sani- utensils too large to be cleaned in sink tizing, the following facilities shall be compartments, manual washing, rins- provided and used:

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(1) An integral heating device or fix- fective means to minimize the entry of ture installed in, on, or under the sani- wash water into the rinse water. Con- tizing compartment of the sink capable veyors in dishwashing machines shall of maintaining the water at a tempera- be accurately timed to assure proper ture of at least 170 °F; and exposure times in wash and rinse cy- (2) A numerically scaled indicating cles in accordance with manufacturers’ thermometer, accurate to ±3 °F, con- specifications attached to the ma- venient to the sink for frequent checks chines. of water temperature; and (E) Drain boards shall be provided (3) Dish baskets of such size and de- and be of adequate size for the proper sign to permit complete immersion of handling of soiled utensils prior to the tableware, kitchenware, and equip- washing and of cleaned utensils fol- ment in the hot water. lowing sanitization and shall be so lo- (G) When chemicals are used for sani- cated and constructed as not to inter- tization, they shall not have con- fere with the proper use of the dish- centrations higher than the maximum washing facilities. This does not pre- permitted under 21 CFR 178.1010 and a clude the use of easily movable dish ta- test kit or other device that accurately bles for the storage of soiled utensils or measures the parts per million con- the use of easily movable dishtables for centration of the solution shall be pro- the storage of clean utensils following vided and used. sanitization. (ii) Mechanical cleaning and sanitizing. (F) Equipment and utensils shall be (A) Cleaning and sanitizing may be flushed or scraped and, when necessary, done by spray-type or immersion dish- soaked to remove gross food particles washing machines or by any other type and soil prior to being washed in a of machine or device if it is dem- dishwashing machine unless a onstrated that it thoroughly cleans prewashcycle is a part of the dish- and sanitizes equipment and utensils. washing machine operation. Equipment These machines and devices shall be and utensils shall be placed in racks, properly installed and maintained in trays, or baskets, or on conveyors, in a good repair. Machines and devices shall way that food-contact surfaces are ex- be operated in accordance with manu- posed to the unobstructed application facturers’ instructions, and utensils of detergent wash and clean rinse wa- and equipment placed in the machine ters and that permits free draining. shall be exposed to all dishwashing cy- (G) Machines (single-tank, sta- cles. Automatic detergent dispensers, tionary-rack, door-type machines and wetting agent dispensers, and liquid spray-type glass washers) using chemi- sanitizer injectors, if any, shall be cals for sanitization may be used: Pro- properly installed and maintained. vided, That, (B) The pressure of final rinse water (1) The temperature of the wash supplied to spray-type dishwashing ma- water shall not be less than 120 °F. chines shall not be less than 15 nor (2) The wash water shall be kept more than 25 pounds per square inch clean. measured in the water line imme- (3) Chemicals added for sanitization diately adjacent to the final rinse con- purposes shall be automatically dis- trol valve. A 1⁄4-inch IPS valve shall be pensed. provided immediately upstream from (4) Utensils and equipment shall be the final rinse control valve to permit exposed to the final chemical sani- checking the flow pressure of the final tizing rinse in accordance with manu- rinse water. facturers’ specifications for time and (C) Machine or water line mounted concentration. numerically scaled indicating ther- (5) The chemical sanitizing rinse mometers, accurate to ±3 °F, shall be water temperature shall be not less provided to indicate the temperature of than 75 °F nor less than the tempera- the water in each tank of the machine ture specified by the machine’s manu- and the temperature of the final rinse facturer. water as it enters the manifold. (6) Chemical sanitizers used shall (D) Rinse water tanks shall be pro- meet the requirements of 21 CFR tected by baffles, curtains, or other ef- 178.1010.

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(7) A test kit or other device that ac- stantial part of the activities of which curately measures the parts per mil- is carrying on propaganda, or other- lion concentration of the solution shall wise attempting, to influence legisla- be available and used. tion, and which does not participate in, (H) Machines using hot water for or intervene in (including the pub- sanitizing may be used provided that lishing or distribution of statements), wash water and pumped rinse water any political campaign on behalf of (or shall be kept clean and water shall be in opposition to) any candidate for pub- maintained at not less than the fol- lic office.’’ lowing temperatures: (5) The Administrator may withdraw (1) Single-tank, stationary-rack, or modify the exemption set forth in dual-temperature machine: § 381.10(e)(1) for a particular establish- Wash temperature ...... 150 °F ment when he or she determines that Final rinse temperature ...... 180 °F such action is necessary to ensure food (2) Single-tank, stationary-rack, sin- safety and public health. Before such gle-temperature machine: action is taken, the owner or operator of the particular establishment shall be Wash temperature ...... 165 °F Final rinse temperature ...... 165 °F notified, in writing, of the reasons for the proposed action and shall be given (3) Single-tank, conveyor machine: an opportunity to respond, in writing, Wash temperature ...... 160 °F to the Administrator within 20 days Final rinse temperature ...... 180 °F after notification of the proposed ac- (4) Multitank, conveyor machine: tion. The written notification shall be served on the owner or operator of the Wash temperature ...... 150 °F establishment in the manner pre- Pumped rinse temperature ...... 160 °F scribed in section 1.147(b) of the De- Final rinse temperature ...... 180 °F partment’s Uniform Rules of Practice (5) Single-tank, pot, pan, and utensil (7 CFR 1.147(b)). In those instances washer (either stationary or moving- where there is conflict of any material rack): fact, the owner or operator of the es- Wash temperature ...... 140 °F tablishment, upon request, shall be af- Final rinse temperature ...... 180 °F forded an opportunity for a hearing with respect to the disputed fact, in ac- (I) All dishwashing machines shall be cordance with rules of practice which thoroughly cleaned at least once a day shall be adopted for the proceeding. or more often when necessary to main- However, such withdrawal or modifica- tain them in a satisfactory operating condition. tion shall become effective pending (iii) Steam. Steam used in contact final determination in the proceeding with food or food-contact surfaces shall when the Administrator determines be free from any materials or additives that an imminent threat to food safety other than those specified in 21 CFR or public health exists, and that such 173.310. action is, therefore, necessary to pro- (4) For purposes of this paragraph, tect the public health, interest or safe- the term ‘‘private nonprofit institu- ty. Such withdrawal or modification tion’’ means ‘‘a corporation, and any shall be effective upon oral or written community chest, fund, or foundation, notification, whichever is earlier, to organized and operated exclusively for the owner or operator of the particular religious, charitable, scientific, testing establishment as promptly as cir- for public safety, literary, or edu- cumstances permit. In the event of oral cational purposes, or to foster national notification, written confirmation or international amateur sports com- shall be given to the owner or operator petition (but only if no part of its ac- of the establishment as promptly as tivities involve the provision of ath- circumstances permit. This withdrawal letic facilities or equipment), or for the or modification shall continue in effect prevention of cruelty to children or pending the completion of the pro- animals, no part of the net earnings of ceeding and any judicial review there- which inures to the benefit of any pri- of, unless otherwise ordered by the Ad- vate shareholder or individual, no sub- ministrator.

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(6) The adulteration and misbranding ments as provided in this section shall provisions of the Act and the regula- be subject to all of the other applicable tions apply to articles which are ex- provisions of the Act and the regula- empted from inspection under tions. Processing plants shall meet the § 381.10(e). sanitary requirements set forth in this [37 FR 9706, May 16, 1972, as amended at 38 part and unless exempted from inspec- FR 16991, June 28, 1973; 45 FR 27922, Apr. 25, tion under the provisions of this sub- 1980; 46 FR 46288, Sept. 16, 1981; 48 FR 2959, part, shall be required to qualify for in- Jan. 24, 1983; 51 FR 29909, Aug. 21, 1986; 53 FR spection and operate as official estab- 24679, June 30, 1988; 57 FR 34184, Aug. 3, 1992] lishments. Slaughtered poultry which is prepared under an exemption author- § 381.11 Exemptions based on religious izing the sale of noneviscerated poultry dietary laws. in commerce shall be individually iden- (a) Any person who slaughters, proc- tified with a label approved by the Ad- esses, or otherwise handles poultry or ministrator which identifies the cler- poultry products which have been or ical official under whose supervision are to be processed as required by rec- the poultry was slaughtered. ognized religious dietary laws may apply for exemption from specific pro- § 381.12 Effect of religious dietary laws visions of the Act or regulations which exemptions on other persons. are in conflict with such religious die- Whenever a slaughterer or processor tary laws. Any person desiring such an is granted an exemption under § 381.11 exemption shall apply in writing to the with respect to the slaughtering or Meat and Poultry Inspection Program, processing of any poultry or poultry Food Safety and Inspection Service, products under this part, under speci- Department of Agriculture, Wash- fied conditions, the sale, offer for sale, ington, DC 20250, setting forth the spe- transportation and other handling in cific provisions of the Act and the reg- commerce by any person of such poul- ulations from which exemption is try and poultry products in accordance sought and setting forth the provisions with such conditions is hereby author- of the religious dietary laws in support ized, except as restricted by the Act. of the requested exemption. In addition, the applicant for such an exemp- § 381.13 Suspension or termination of tion shall submit a statement from the exemptions. clerical official having jurisdiction over the enforcement of the religious (a) The Administrator may, by order, dietary laws with respect to the poul- in accordance with the applicable rules try or poultry products involved, which of practice suspend or terminate any identifies the requirements of such exemption under § 381.10(a) with respect laws pertaining to the slaughter of the to any person whenever he finds that poultry and the processing or other such action will aid in effectuating the handling of the poultry products in- purposes of the Act. Failure to comply volved, and certifies that such require- with the conditions of the exemption, ments are in conflict with specific pro- including, but not limited to, failure to visions of the Act and regulations from process poultry and poultry products which the exemption is sought. under clean and sanitary conditions (b) The Administrator, upon a deter- may result in termination of an exemp- mination that an exemption should be tion, in addition to any other penalties granted, will grant such exemption to provided by law. the extent necessary to avoid conflict (b) Except as provided in § 381.10(c), with the religious requirements while the Administrator may extend the re- still effectuating the purposes of the quirements of the Act to any establish- Act. He may impose such conditions as ment in any State or organized terri- to sanitary standards, practices, and tory at which poultry products are procedures in granting such exemption processed for distribution solely within as he deems necessary to effectuate the such jurisdiction if he determines in purposes of the Act. Any person who accordance with the provisions of sub- processes poultry or poultry products paragraph 5(c)(1) of the Act that the es- under exemption from certain require- tablishment is producing adulterated

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poultry products which would clearly puted on the basis of the moist, endanger the public health. deboned, cooked poultry in the ready- to-serve product when prepared accord- § 381.14 Inspection concerning pur- ing to the serving directions on the portedly exempted operations. consumer package. Inspectors of the Inspection Service (b) Any human food product (in an are authorized to make inspections in institutional pack), not provided for in accordance with law to ascertain paragraph (c) of this section, if: whether any of the provisions of the (1) It is prepared for sale only to in- Act or the regulations applying to pro- stitutional users, such as hotels, res- ducers, retailers, or other persons pur- taurants, and boardinghouses, for use porting to be exempted from any reas a soup base or flavoring; quirements under this subpart have (2) It contains less than 15 percent been violated. cooked poultry meat (deboned white or dark poultry meat or both) and/or § 381.15 Exemption from definition of ‘‘Mechanically Separated (Kind of ‘‘poultry product’’ of certain human Poultry)’’ as defined in § 381.173, com- food products containing poultry. puted on the basis of the moist The following articles contain poul- deboned, cooked poultry meat and/or try ingredients only in a relatively ‘‘Mechanically Separated (Kind of small proportion or historically have Poultry)’’ in such product; and not been considered by consumers as (3) It complies with the provisions of products of the poultry food industry. paragraphs (a)(3), (4), and (5) of this Therefore said articles are exempted section in all respects. from the definition of ‘‘poultry prod- (c) Bouillon cubes, poultry broths, uct’’ and the requirements of the Act gravies, sauces, seasonings, and and the regulations applicable to poul- flavorings if: try products, if they comply with the (1) They contain poultry meat and/or conditions specified in this section. ‘‘Mechanically Separated (Kind of (a) Any human food product (in a Poultry)’’ as defined in § 381.173 or poul- consumer package) not provided for in try fat only in condimental quantities; paragraph (c) of this section, if: (2) They comply with the provisions (1) It contains less than 2 percent of paragraphs (a)(3), (4), and (5) of this cooked poultry meat (deboned white or section in all respects; and dark poultry meat, or both) and/or (3) In the case of poultry broth, it ‘‘Mechanically Separated (Kind of will not be used in the processing of Poultry)’’ as defined in § 381.173; any poultry product in any official es- (2) It contains less than 10 percent of tablishment. cooked poultry skins, giblets, or fat, (d) Fat capsules and sandwiches con- separately, and less than 10 percent of taining poultry products if they com- cooked poultry skins, giblets, fat, and ply with the provisions of paragraphs meat (as meat is limited in paragraph (a)(3), (4), and (5) of this section in all (a)(1) of this section) or ‘‘Mechanically respects. Separated (Kind of Poultry)’’ as defined (e) Products of the types specified in in § 381.173, in any combination; this section except those specified in (3) The poultry ingredients used in paragraphs (c) and (d) of this section the product were prepared under in- will be deemed to be represented as spection as defined in § 381.1, or were poultry products if the kind name of inspected under a foreign inspection the poultry (chicken, turkey, etc.) is system approved under § 381.196(b) and used in the product name of the prod- imported in compliance with the Act uct without appropriate qualification. and the regulations; For example, a consumer-packaged (4) The immediate container of the noodle soup product containing less product bears a label which shows the than 2 percent chicken meat on a name of the product in accordance with ready-to-serve basis may not be labeled this section; and ‘‘Chicken Noodle Soup’’ but, when ap- (5) The product is not represented as propriate, could be labeled as ‘‘Chicken a poultry product. The aforesaid per- Flavored Noodle Soup.’’ Products ex- centages of ingredients shall be com- empted under this section are subject

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to the requirements of the Federal ance with the regulations. FSIS will Food, Drug, and Cosmetic Act. grant inspection, subject to § 381.21, when these requirements are met. [37 FR 9706, May 16, 1972, as amended at 60 FR 55982, Nov. 3, 1995] (b) FSIS shall give notice in writing to each applicant granted inspection and shall specify in the notice the es- Subpart D—Application for In- tablishment, including the limits of spection; Grant or Refusal of the establishment’s premises, to which Inspection the grant pertains. § 381.16 How application shall be [62 FR 45026, Aug. 25, 1997] made. § 381.21 Refusal of inspection. The operator of each establishment of the kind required by § 381.6 to have (a) Any application for inspection in inspection shall make application to accordance with this part may be de- the Administrator for inspection serv- nied or refused in accordance with the ice. In cases of change of name, owner- rules of practice in part 500 of this ship, or location, a new application chapter. (b)(1) Any applicant for inspection at shall be made. an establishment where the operations § 381.17 Filing of application. thereof may result in any discharge into the navigable waters of the United Every application for inspection at States is required by subsection 21(b) of any establishment shall be made by the the Federal Water Pollution Control operator on a form furnished by the Act, as amended, to provide the Admin- Meat and Poultry Inspection Program, istrator with a certification as pre- Food Safety and Inspection Service, scribed in said subsection that there is U.S. Department of Agriculture, Wash- reasonable assurance that such activ- ington, DC 20250, and shall include all ity will be conducted in a manner information called for by that form, in- which will not violate the applicable cluding the name of any subsidiary cor- water quality standards. No grant of poration that will prepare any poultry inspection can be issued after April 3, product or conduct any other operation 1970 (the date of enactment of the at the establishment for which inspec- Water Quality Improvement Act), un- tion is requested. The applicant for in- less such certification has been ob- spection will be held responsible for tained, or is waived because of failure compliance by all its subsidiaries with or refusal of the State, interstate agen- the requirements of the regulations at cy, or the Administrator of the Envi- such establishments if inspection is ronmental Protection Agency to act on granted. Processing of poultry products a request for certification within 1 year and other operations at the establish- after receipt of such request. Further, ment for which inspection is granted upon receipt of an application for in- may be conducted only by the appli- spection and a certification as required cant, except that such a subsidiary of by subsection 21(b) of the Federal the grantee, may conduct such oper- Water Pollution Control Act, the Ad- ations at such establishment. ministrator (as defined in § 381.1) is required by paragraph (2) of said sub- § 381.18 Authority of applicant. section to notify the Administrator of Any person applying for inspection the Environmental Protection Agency service may be required at the discre- for proceedings in accordance with that tion of the Administrator to dem- paragraph. No grant of inspection can onstrate that the operator of the estab- be made until the requirements of said lishment authorized him to do so. paragraph (2) have been met. (2) However, certification under sub- § 381.20 Survey and grant of inspec- section 21(b) of the Federal Water Pol- tion. lution Control Act is not initially re- (a) Before inspection is granted, FSIS quired in connection with an applica- shall survey the establishment to de- tion for inspection granted after April termine if the construction and facili- 3, 1970, for facilities existing or under ties of the establishment are in accord- construction on April 3, 1970, although

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certification for such facilities is re- plan, in accordance with § 417.4 of this quired to be obtained within the 3–year chapter. period immediately following April 3, [61 FR 38866, July 25, 1996] 1970. Failure to obtain such certification or to meet the other requirements of subsection 21(b) prior to April Subpart E—Inauguration of In- 3, 1973, will result in the termination of spection; Official Establish- inspection at such facilities on that ment Numbers; Separation of date. Establishments and Other Re- (3) Further, any application for in- quirements; Withdrawal of In- spection pending on April 3, 1970, and spection granted within 1 year thereafter shall not require certification for 1 year fol- § 381.25 Official establishment num- lowing the grant of inspection but such bers. grant of inspection shall terminate at An official establishment number the end of 1 year after its issuance un- shall be assigned to each establishment less prior thereto such certification has granted inspection service. Such num- been obtained and the other require- ber shall be used to identify all con- ments of subsection 21(b) are met. tainers of inspected poultry products (4) In the case of any activity which prepared in the establishment. An es- will affect water quality but for which tablishment shall not have more than there are no applicable water quality one establishment number. standards, no certification is required prior to the grant of inspection but § 381.26 Separation of establishments. such grant will be conditioned upon a Each official establishment shall be requirement of compliance with the separate and distinct from any other purpose of the Federal Water Pollution official establishment and from any Control Act as provided in paragraph unofficial establishment except an es- 21(b)(9) of said Act. tablishment preparing meat products [37 FR 9706, May 16, 1972, as amended at 64 under the Federal Meat Inspection Act FR 66545, Nov. 29, 1999] or under State meat inspection. Fur- ther, doorways, or other openings, may § 381.22 Conditions for receiving in- be permitted between establishments spection. at the discretion of the Administrator (a) Before being granted Federal in- and under such conditions as he may spection, an establishment shall have prescribe. developed written sanitation Standard Operating Procedures, in accordance § 381.27 Inauguration of service; notifi- with part 416 of this chapter. cation concerning regulations; sta- (b) Before being granted Federal in- tus of uninspected poultry prod- spection, an establishment shall have ucts. conducted a hazard analysis and devel- The inspector in charge or his super- oped and validated a HACCP plan, in visor shall, upon or prior to the inau- accordance with §§ 417.2 and 417.4 of this guration of service, inform the oper- chapter. A conditional grant of inspec- ator of the establishment of the re- tion shall be issued for a period not to quirements of the regulations. If the exceed 90 days, during which period the establishment at the time service is in- establishment must validate its augurated contains any poultry prod- HACCP plan. uct which has not been inspected and (c) Before producing new product for marked in compliance with the regula- distribution in commerce, an establish- tions, its identity shall be maintained, ment shall have conducted a hazard and it shall not be represented or dealt analysis and developed a HACCP plan with as a product which has been inapplicable to that product in accord- spected. Such products may not be ance with § 417.2 of this chapter. During shipped in commerce unless such prod- a period not to exceed 90 days after the ucts are eligible for such shipment date the new product is produced for under an exemption from inspection distribution in commerce, the estab- under subpart C and comply with all lishment shall validate its HACCP requirements of said subpart.

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§ 381.28 Report of violations. employee responsibilities and conduct. Each inspector, agent, representa- The setting forth of certain prohibi- tive, or employee of the Inspection tions in this part in no way limits the Service shall report, in the manner pre- applicability of such general or other scribed by the Administrator, all viola- regulations or instructions. tions of the Act and noncompliance § 381.35 Appeal inspections; how made. with the regulations of which he has knowledge. Any person receiving inspection service may, if dissatisfied with any deci- Subpart F—Assignment and Au- sion of an inspector relating to any inspection, file an appeal from such deci- thorities of Program Employ- sion: Provided, That such appeal is filed ees; Appeals within 48 hours from the time the decision was made. Any such appeal from a §§ 381.30–381.31 [Reserved] decision of an inspector shall be made § 381.32 Access to establishments. to his immediate superior having jurisdiction over the subject matter of the [See § 300.6 of this chapter regarding appeal, and such superior shall deter- access to establishments and other mine whether the inspector’s decision places of business.] was correct. Review of such appeal de- [69 FR 255, Jan. 5, 2004] termination, when requested, shall be made by the immediate superior of the § 381.33 Identification. employee of the Department making Each inspector will be furnished with the appeal determination. The cost of a numbered official inspection badge, any such appeal shall be borne by the which shall remain in his or her posses- appellant if the Administrator deter- sion at all times, and which shall be mines that the appeal is frivolous. The worn in such manner and at such times charges for such frivolous appeal shall as the Administrator may prescribe. be at the rate of $9.28 per hour for the [59 FR 42156, Aug. 17, 1994, as amended at 69 time required to make the appeal in- FR 255, Jan. 5, 2004] spection. The poultry or poultry products involved in any appeal shall be § 381.34 Financial interest of inspec- identified by U.S. retained tags and tors. segregated in a manner approved by (a) No inspector shall inspect any the inspector pending completion of an poultry or poultry product in which he, appeal inspection. his spouse, minor child, partner, orga- [48 FR 11419, Mar. 18, 1983, as amended at 60 nization in which he is serving as offi- FR 67456, Dec. 29, 1995] cer, director, trustee, partner, or employee, or any person with whom he is negotiating or has any arrangement Subpart G—Facilities for Inspec- concerning prospective employment, is tion; Overtime and Holiday financially interested. Service; Billing Establishments (b) All inspectors are subject to stat- utory restrictions with respect to po- § 381.36 Facilities required. litical activities; e.g., 5 U.S.C. 7324 and (a) Inspector’s Office. Office space, in- 1502. cluding, but not being limited to fur- (c) Violation of the provisions of nishings, light, heat, and janitor serv- paragraph (a) of this section or the pro- ice, shall be provided rent free in the visions of applicable statutes ref- official establishment, for the use of erenced in paragraph (b) of this section Government personnel for official pur- will constitute grounds for dismissal in poses. The room or space set apart for the case of appointees and for revoca- this purpose must meet the approval of tion of licenses in the case of licensees. the Inspection Service and be conven- (d) Inspectors are subject to all appli- iently located, properly ventilated, and cable provisions of law and regulations provided with lockers or file cabinets and instructions of the Department suitable for the protection and storage and the Food Safety and Inspection of supplies and with facilities suitable Service and other authority concerning for inspectors to change clothing. At

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the discretion of the Administrator, so that it can be easily and rapidly ad- small plants requiring the services of justed for a minimum of 14 inches less than one full-time inspector need vertically while standing on the plat- not furnish facilities for Program em- form. The platform shall be a min- ployees as prescribed in this section, imum length of 4 feet and have a min- where adequate facilities exist in a imum width of 2 feet; the platform nearby convenient location. Each offi- shall be designed with a 42-inch high cial establishment shall provide com- rail on the back side and with 1⁄2-inch mercial laundry service for inspectors’ foot bumpers on both sides and front to outer work clothing, or disposable allow safe working conditions. The outer work garments designed for one- platform must have a safe lift mecha- time use, or uniform rental service gar- nism and be large enough for the in- ments which are laundered by the rent- spector to sit on a stool and to change al service. stations during breaks or station rota- (b) Facilities for ante mortem inspection. tion. A suspect pen is required for adequate ratite inspection. (v) Conveyor line stop/start switches (c) Facilities for the Streamlined In- shall be located within easy reach of spection System (SIS). The following each inspector. requirements for lines operating under (vi) A trough or other facilities shall SIS are in addition to the normal re- extend beneath the conveyor at all quirements to obtain a grant of inspec- places where processing operations are tion. The requirements for SIS in conducted from the point where the § 381.76(b) also apply. carcass is opened to the point where (1) The following provisions shall the trimming has been performed. The apply to every inspection station: trough must be of sufficient width to (i) The conveyor line shall be level preclude trimmings, drippage, and de- for the entire length of the inspection bris from accumulating on the floor or station. The vertical distance from the platforms. The clearance between the bottom of the shackles to the top of suspended carcasses and the trough the adjustable platform (paragraph must be sufficient to preclude contami- (c)(1)(iv) of this section) in its lowest nation of carcasses by splash. position shall not be less than 60 (vii) A minimum of 200-footcandles of inches. shadow-free lighting with a minimum (ii) Floor space shall consist of 4 feet color rendering index value of 85 where along the conveyor line for the inspec- the birds are inspected to facilitate in- tor, and 4 feet for the establishment spection. helper. A total of at least 8 feet along (viii) Online handrinsing facilities the conveyor line shall be supplied for with a continuous flow of water must one inspection station and 16 feet for be provided for and within easy reach two-inspection stations. of each inspector and each establish- (iii) Selectors or ‘‘kickouts’’ shall be installed in establishments with two ment helper. The hand-contact element inspection stations on a line so each in- must be rinsed automatically with a spector will receive birds on 12-inch sufficient volume of water to remove centers with no intervening birds to all fat, tissue, debris, and other extra- impede inspection. The selector must neous material from the hand contact move the bird to the edge of the trough element after each use. Both hot and for the inspector and establishment cold running water shall be available helper. The selectors must be smooth, at each inspection station on the evis- steady, and consistent in moving the cerating line and shall be delivered birds parallel and through the inspec- through a suitable mixing device con- tion station. Birds shall be selected and trolled by the inspector. Alternatively, released smoothly to avoid swinging water for hand washing shall be deliv- when entering the inspection station. ered to such inspection stations at a (iv) Each inspector’s station shall minimum temperature of 65 degrees F. have a platform that is slip-resistant (ix) Hangback racks shall be provided and can be safely accessed by the infor and positioned within easy reach of spector. The platform shall be designed the establishment helpers.

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(x) Each inspection station shall be lishment employee presenting the provided with receptacles for con- birds, 4 feet for the inspector, and 4 demned carcasses and parts. Such re- feet for the establishment helper. A ceptacles shall comply with the per- total of at least 42 feet along the conformance standards in § 416.3(c) of this veyor line shall be supplied for three chapter. inspection stations. (2) The following provisions shall (iii) Selectors or ‘‘kickouts’’ shall be apply only to prechill and postchill re- installed so the three inspection sta- inspection stations: tions will receive birds on 18-inch cen- (i) Floor space shall consist of a min- ters with no intervening birds to im- imum of 3 feet along each conveyor pede inspection. The selector must line and after each chiller to allow car- move the bird to the end of the trough casses to be removed for evaluation. for the presenter, inspector, and estab- The space shall be level and protected lishment helper. The selectors must be from all traffic and overhead obstruc- smooth, steady, and consistent in mov- tions. ing the birds parallel and through the (ii) The vertical distance from the inspection station. Birds shall be se- bottom of the shackles to the floor lected and released smoothly to avoid shall not be less than 48 inches. splashing the mirror (paragraph (iii) A table, at least 2 feet wide, 2 (d)(1)(vii) of this section) and swinging feet deep, and 3 feet high designed to be when entering the inspection station. readily cleanable and drainable shall Guide bars shall not extend in front of be provided for reinspecting the sam- the inspection station mirror to avoid pled birds. obstructing the inspector’s view. (iv) A minimum of 200-footcandles of (iv) Each inspector’s station shall shadow-free lighting with a minimum have an easily and rapidly adjustable color rendering index of 85 on the table platform, with a minimum of 14 inches surface shall be provided. of vertical adjustment, which covers (v) A separate clip board holder shall the entire length of the station (4 feet) be provided for holding the recording and has a minimum width of 2 feet. The sheets. platform shall be designed with a 42- (vi) Handwashing facilities shall be inch high rail on the back side and provided for and shall be within easy with 1⁄2-inch foot bumpers on both sides access of persons working at the sta- and front to allow safe working conditions. tions. (vii) Hangback racks designed to hold (v) Conveyor line stop/start switches 10 carcasses shall be provided for and shall be located within easy reach of positioned within easy reach of the per- each inspector. son at the station. (vi) A trough shall extend beneath (d) Facilities for the New Line Speed the conveyor at all places where proc- (NELS) inspection system. The fol- essing operations are conducted from lowing requirements for lines operating the point where the carcass is opened under the NELS inspection system are to the point where the trimming has in addition to the normal requirements been performed. The trough must be of to obtain a grant of inspection and to sufficient width to preclude trimmings, the requirements for NELS in § 381.76 drippage, and debris from accumu- (b) and (c). lating on the floor or platforms. The (1) The following provisions shall clearance between the suspended car- apply to every inspection station: casses and the trough must be suffi- (i) The conveyor line shall be level cient to preclude contamination of car- for the entire length of the inspection casses by splash. station. The vertical distance from the (vii) A distortion-free mirror, at least bottom of the shackles to the top of 3 feet wide and 2 feet high, shall be the adjustable platform (paragraph mounted at each inspection station so (d)(1)(iv) of this section) in its lowest that it can be adjusted between 5 and position shall not be less than 60 15 inches behind the shackles, tilt up inches. and down, tilt from side to side, and be (ii) Floor space shall consist of 6 feet raised and lowered. The mirror shall be along the conveyor line for the estab- positioned in relation to the inspection

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platform so that the inspector can po- requirements for lines operating under sition himself/herself opposite it 8 to 12 the NTI System are in addition to the inches from the downstream edge. The normal requirements to obtain a grant mirror must be maintained abrasion of inspection and to the requirements free. for the NTI System in § 381.76 (b) and (viii) A minimum of 200-footcandles (c). of shadow-free lighting with minimum (1) The following provisions apply to color rendering index value of 85 1 every inspection station: where the birds are inspected to facili- (i) The conveyor line must be level tate inspection. A light shall also be for the entire length of the inspection positioned above and slightly in front station. The vertical distance from the of the mirror to facilitate the illumina- bottom of the shackles to the top of tion of the bird and mirror surfaces. the adjustable platform (paragraph (ix) ‘‘One-line’’ handrinsing facilities (e)(1)(iii) of this section) in its lowest with a continuous flow of water shall position shall not be less than 60 be provided for and within easy reach inches. of each inspector and each establish- (ii) Floor space shall consist of 8 feet ment presenter and helper. along the conveyor line; at least 4 feet (x) Hangback racks shall be provided for the inspector, and at least 4 feet for for and positioned within easy reach of the establishment helper. the establishment helpers. (iii) The inspector’s station shall (xi) Each inspection station shall be have an easily and rapidly adjustable provided with receptacle for con- platform with a minimum width of 2 demned carcasses and parts. Such re- feet which covers the entire length of ceptacles shall comply with the per- the station (4 feet). The platform must formance standards in § 416.3(c) of this adjust vertically a minimum of 14 chapter. inches, and must have a 42-inch rail on (2) The following provisions shall the back side and 1⁄2-inch foot bumpers apply only to the reinspection station: on the sides and the front to allow safe (i) Floor space shall consist of 6 feet working conditions. along the conveyor line. The space (iv) Conveyor line stop/start switches shall be level and protected from all shall be located within easy reach of traffic and overhead obstructions. each inspector. (ii) The vertical distance from the (v) A trough or other facilities shall bottom of the shackles to the floor extend beneath the conveyor at all shall not be less than 48 inches. places where processing operations are (iii) A table, at least 3 feet wide and conducted from the point where the 2 feet deep, shall be provided for re- carcass is opened to the point where inspecting the sample birds. the trimming has been performed. The (iv) A minimum of 200-footcandles of trough must be wide enough to prevent shows free lighting with a minimum trimmings, drippage, and debris from color rendering index of 85 1 on the accumulation on the floor or plat- table surface. forms. The clearance between sus- (v) A separate clip board holder shall pended carcasses and the trough must be provided for holding the recording be sufficient to prevent contamination sheets. of carcasses by splash. (vi) Handwashing facilities shall be (vi) A minimum of 200 foot-candles of provided for and shall be within easy shadow-free lighting with a minimum reach of persons working at the sta- color rendering index value of 85 1 tion. where the birds are inspected to facili- (vii) Hangback racks designed to hold tate inspection is required. The min- 10 carcasses shall be provided for and imum lighting requirement for inspec- positioned within easy reach of the per- tion stations in § 381.52(b) shall not son at the station. apply. (e) Facilities for the New Turkey In- (vii) On-line handrinsing facilities spection (NTI) System. The following with a continuous flow of water shall

1 This requirement may be met by deluxe 1 This requirement may be met by deluxe cool white type of fluorescent lighting. cool white fluorescent lighting.

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be provided for and within easy reach spector’s tour of duty once it begins. of each inspector and each establish- Lunch periods may be 30 minutes, 45 ment helper. minutes, or in any case may not exceed (viii) Hangback racks shall be pro- one hour in duration. Once established, vided for and within easy reach of the the lunch period must remain rel- establishment helper. atively constant as to time and dura- (ix) Each inspection station shall be tion. Lunch periods for inspectors shall provided with receptacles for con- not, except as provided herein, occur demned carcasses and parts. Such re- prior to 4 hours after the beginning of ceptacles shall comply with the per- scheduled operations nor later than 5 formance standards in § 416.3(c) of this hours after operations begin. In plants chapter. where a company rest break of not less (2) The following provisions shall than 30 minutes is regularly observed, apply only to the reinspection station: approximately midpoint between start (i) Floor space shall consist of a min- of work and the lunch period, and the imum of 3 feet along the conveyor line inspector is allowed this time to meet so carcasses can be removed from each his personal needs, the lunch period line for evaluation. The space shall be may be scheduled as long as 51⁄2 hours level and protected from all traffic and after the beginning of scheduled oper- overhead obstructions. ations. (ii) The vertical distance from the bottom of the shackles to the floor (c) Official establishments, import- must not be less than 48 inches. ers, and exporters shall be provided in- (iii) A table at least 3 feet wide and 2 spection service, without charge, up to feet deep designed to be readily clean- 8 hours per shift during the basic work- able and drainable shall be provided for week subject to the provisions of reinspecting the sampled birds. § 381.38: Provided, That any additional (iv) A minimum of 200 foot-candles of shifts meet requirements as deter- shadow-free lighting with a minimum mined by the Administrator or his des- color rendering index of 85 1 at the ignee. The basic workweek shall con- table surface is required. sist of 5 consecutive 8-hour days within (v) A clipboard holder shall be pro- the administrative workweek Sunday vided for holding the recording sheets. through Saturday, and shall include (vi) Handwashing facilities shall be the time for FSIS inspection program provided for and within easy reach of personnel to put on required gear and persons working at the station. to walk to a work station, and the time (vii) Hangback racks designed to hold for FSIS inspection program personnel 10 carcasses shall be provided for and to return from a work station and re- positioned within easy reach of the per- move required gear, excluding the son at this station. lunch period; except that, when possible, the Department shall schedule [37 FR 9706, May 16, 1972, as amended at 38 the basic workweek so as to consist of FR 9794, Apr. 20, 1973; 47 FR 23434, May 28, 1982; 49 FR 42554, Oct. 23, 1984; 50 FR 37512, 5 consecutive 8-hour days Monday Sept. 16, 1985; 52 FR 39209, Oct. 21, 1987; 64 FR through Friday, and shall include the 56416, Oct. 20, 1999; 66 FR 22905, May 7, 2001] time for FSIS inspection program personnel to put on required gear and to § 381.37 Schedule of operations. walk to a work station, and the time (a) No operations requiring inspec- for FSIS inspection program personnel tion shall be conducted except under return from a work station and remove the supervision of an Inspection Serv- required gear, excluding the lunch pe- ice employee. All eviscerating of poul- riod. The Department may depart from try and further processing shall be the basic workweek in those cases done with reasonable speed, consid- where maintaining such a schedule ering the official establishment’s fa- would seriously handicap the Depart- cilities. ment in carrying out its functions. (b) A shift is a regularly scheduled These provisions are applicable to all operating period, exclusive of meal- official establishments except in cer- time. One lunch period is the only offi- tain cases as provided in § 381.145(h) of cial authorized interruption in the in- this subchapter.

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(d)(1) Each official establishment ton’s Birthday, the third Monday in shall submit a work schedule to the February; Memorial Day, the last Mon- area supervisor for approval. In consid- day in May; Independence Day, July 4; eration of whether the approval of an Labor Day, the first Monday in Sep- establishment work schedule shall be tember; Columbus Day, the second given, the area supervisor shall take in Monday in October; Veterans’ Day, No- account the efficient and effective use vember 11; Thanksgiving Day, the of inspection personnel. The work fourth Thursday in November; Christ- schedule must specify the workweek, mas Day, December 25. When any of daily clock hours of operation, and the above-listed holidays falls outside lunch periods for all departments of the basic workweek, the nearest work- the establishment requiring inspection. day within that week shall be the holi- (2) Establishments shall maintain day. consistent work schedules. Any request by an establishment for a change in its [40 FR 45801, Oct. 3, 1975, as amended at 43 FR work schedule involving changes in the 51754, Nov. 7, 1978; 50 FR 51513, Dec. 18, 1985; 52 FR 5, Jan. 2, 1987; 53 FR 13398, Apr. 22, 1988; workweek or an addition or elimi- 54 FR 6390, Feb. 10, 1989] nation of shifts shall be submitted to the area supervisor at least 2 weeks in § 381.39 Basis of billing for overtime advance of the proposed change. Fre- and holiday services. quent requests for change shall not be approved: Provided, however, Minor de- (a) Each recipient of overtime or hol- viations from a daily operating sched- iday inspection service, or both, shall ule may be approved by the inspector be billed as provided for in § 381.38(a) in charge if such request is received on and at the rate specified in § 391.3, in the day preceding the day of change. increments of quarter hours. For bill- (3) Requests for inspection service ing purposes, 8 or more minutes shall outside an approved work schedule be considered a full quarter hour. Bill- shall be made as early in the day as ing will be for each quarter hour of possible for overtime work to be per- service rendered by each Inspection formed within that same workday; or Service employee. made prior to the end of the day’s oper- (b) Official establishments, importation when such a request will result in ers, or exporters requesting and receiv- overtime service at the start of the fol- ing the services of an Inspection Serv- lowing day: Provided, That an inspector ice employee after he has completed may be recalled to his assignment after his day’s assignment and left the prem- the completion of his daily tour of duty ises, or called back to duty during any under the provisions of § 381.39(b). overtime or holiday period, shall be billed for a minimum of 2 hours over- [40 FR 45800, Oct. 3, 1975, as amended at 40 FR time or holiday inspection service at 50719, Oct. 31, 1975; 41 FR 15401, Apr. 13, 1976; the established rate. 48 FR 6893, Feb. 16, 1983; 51 FR 32304, Sept. 11, 1986; 76 FR 33980, June 10, 2011] (c) Bills are payable upon receipt and become delinquent 30 days from the § 381.38 Overtime and holiday inspec- date of the bill. Overtime or holiday in- tion service. spection will not be performed for any- (a) The management of an official es- one having a delinquent account. tablishment, an importer, or an ex- [40 FR 45801, Oct. 3, 1975, as amended at 54 FR porter shall reimburse the Program, at 6390, Feb. 10, 1989] the rate specified in § 391.3, for the cost of the inspection service furnished on any holiday specified in paragraph (b) Subpart H [Reserved] of this section; or for more than 8 hours on any day, or more than 40 Subpart I—Operating Procedures hours in any administrative workweek Sunday through Saturday. § 381.65 Operations and procedures, (b) Holidays for Federal employees generally. shall be New Year’s Day, January 1; (a) Operations and procedures involv- Birthday of Martin Luther King, Jr., ing the processing, other handling, or the third Monday in January; Washing- storing of any poultry product must be

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strictly in accord with clean and sani- Eviscerated poultry to be shipped from tary practices and must be conducted the establishment in packaged form in a manner that will result in sanitary shall be maintained at 40 °F. or less, processing, proper inspection, and the except that during further processing production of poultry and poultry prod- and packaging operations, the internal ucts that are not adulterated. temperature may rise to a maximum of (b) Poultry must be slaughtered in 55 °F.: Provided, That immediately accordance with good commercial prac- after packaging, the poultry is placed tices in a manner that will result in under refrigeration at a temperature thorough bleeding of the carcasses and that will promptly lower the internal ensure that breathing has stopped prior temperature of the product to 40 °F. or to scalding. Blood from the killing op- less, or the poultry is placed in a freez- eration must be confined to a rel- er. Poultry which is to be held at the atively small area. plant in packaged form in excess of 24 (c) When thawing frozen ready-to- hours shall be held in a room at a tem- cook poultry in water, the establish- perature of 36 °F. or less. ment must use methods that prevent (2) Major portions of poultry car- adulteration of, or net weight gain by, casses, as defined in § 381.170(b)(22), and the poultry. poultry carcasses shall be chilled to 40 (d) The water used in washing the °F. or lower within the following speci- poultry must be permitted to drain fied times: freely from the body cavity. (e) Poultry carcasses contaminated Weight of carcass Time with visible fecal material shall be pre- (hours) vented from entering the chilling tank. Under 4 pounds ...... 4 (f) Detached ova may be collected for 4 to 8 pounds ...... 6 human food and handled only in ac- Over 8 pounds ...... 8 cordance with 9 CFR 590.44 and may leave the establishment only to be (c) Ice and water chilling. (1) Only ice moved to an official egg product proc- produced from potable water may be essing plant for processing. Ova from used for ice and water chilling, except condemned carcasses must be con- that water and ice used for chilling demned and treated as required in may be reused in accordance with § 381.95. § 416.2(g). The ice must be handled and stored in a sanitary manner. [66 FR 1771, Jan. 9, 2001; 66 FR 19714, Apr. 17, 2001] (2)(i) Poultry chilling equipment must be operated in a manner con- § 381.66 Temperatures and chilling sistent with meeting the applicable and freezing procedures. pathogen reduction performance stand- (a) General. Temperatures and proce- ards for raw poultry products as set dures that are necessary for chilling forth in § 381.94 and the provisions of and freezing ready-to-cook poultry, in- the establishment’s HACCP plan. cluding all edible portions thereof, (ii) Major portions of poultry car- must be in accordance with operating casses, as defined in § 381.170(b)(22), may procedures that ensure the prompt re- be chilled in water and ice. moval of the animal heat, preserve the (3) Previously chilled poultry car- condition and wholesomeness of the casses and major portions must be poultry, and assure that the products maintained constantly at 40 °F or are not adulterated. below until removed from the vats or (b) General chilling requirements, ex- tanks for immediate packaging. Such cept for ratites. (1) All poultry that is products may be removed from the vats slaughtered and eviscerated in the offi- or tanks prior to being cooled to 40 °F cial establishment shall be chilled im- or below, for freezing or cooling in the mediately after processing so that the official establishment. Such products internal temperature is reduced to 40 must not be packed until after they °F. or less, as provided in paragraph have been chilled to 40 °F or below, ex- (b)(2) of this section unless such poul- cept when the packaging will be fol- try is to be frozen or cooked imme- lowed immediately by freezing at the diately at the official establishment. official establishment.

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(4) Giblets must be chilled to 40 °F or (4) Warm packaged ready-to-cook below within 2 hours from the time poultry which is to be chilled by imme- they are removed from the inedible diate entry into a freezer within the of- viscera, except that when they are ficial establishment shall within 2 cooled with the carcass, the require- hours from time of slaughter be placed ments of paragraph (b)(2) of this sec- in a plate freezer or a freezer with a tion must apply. Any of the acceptable functioning circulating air system methods of chilling the poultry carcass where a temperature of ¥10 °F. or may be followed in cooling giblets. lower is maintained. (d) Water absorption and retention. (1) (5) Frozen poultry shall be held under Poultry washing, chilling, and draining conditions which will maintain the practices and procedures must be such product in a solidly frozen state with as will minimize water absorption and retention at time of packaging. temperature maintained as constant as (2) The establishment must provide possible under good commercial prac- scales, weights, identification devices, tice. and other supplies necessary to con- [37 FR 9706, May 16, 1972, as amended at 39 duct water tests. FR 4568, 4569, Feb. 5, 1974; 40 FR 42338, Sept. (e) Air chilling. In air chilling ready- 12, 1975; 49 FR 9411, Mar. 13, 1984; 60 FR 44412, to-cook poultry, the internal tempera- Aug. 25, 1995; 63 FR 48960, Sept. 11, 1998; 66 FR ture of the carcasses shall be reduced 1771, Jan. 9, 2001; 66 FR 19714, Apr. 17, 2001; 66 to 40 °F. or less within 16 hours. FR 22905, May 7, 2001] (f) Freezing. (1) Ready-to-cook poultry which is to be or is labeled with de- § 381.67 Young chicken and squab scriptive terms such as ‘‘fresh frozen,’’ slaughter inspection rate maxi- ‘‘quick frozen’’ or ‘‘frozen fresh’’ or any mums under traditional inspection other term implying a rapid change procedure. from a fresh state to a frozen state The maximum number of birds to be shall be placed into a freezer within 48 inspected by each inspector per minute hours after initial chilling in accord- under the traditional inspection proce- ance with paragraph (b) of this section. dure for the different young chicken During this period, if such poultry is and squab slaughter line configurations not immediately placed into a freezer are specified in the following table. after chilling and packaging, it shall be These maximum rates will not be ex- held at 36 °F. or lower. ceeded. The inspector in charge will be (2) Ready-to-cook poultry shall be responsible for reducing production frozen in a manner so as to bring the line rates where in the inspector’s internal temperature of the birds at judgment the prescribed inspection ° the center of the package to 0 F. or procedure cannot be adequately per- below within 72 hours from the time of formed within the time available, ei- entering the freezer. Such procedures ther because the birds are not pre- shall not apply to raw poultry product described in § 381.129(b)(6)(i) of this sub- sented by the official establishment in chapter. such a manner that the carcasses, in- (3) Upon written request, and under cluding both internal and external sur- such conditions as may be prescribed faces and all organs, are readily acces- by the Administrator, in specific cases, sible for inspection, or because the ready-to-cook poultry which is to be health conditions of a particular flock frozen immediately may be moved dictate a need for a more extended in- from the official establishment prior to spection procedure. The standards in freezing: Provided, That the plant and 381.170(a) of this part specify which freezer are so located and such nec- classes of birds constitute young chick- essary arrangements are made that the ens and squabs. Section 381.76(b) speci- Inspection Service will have access to fies when either the traditional inspec- the freezing room and adequate oppor- tion procedure or the modified tradi- tunity to determine compliance with tional inspection procedure can or the time and temperature require- must be used. ments specified in paragraph (f)(2) of this section.

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MAXIMUM PRODUCTION LINE RATES—CHICKENS shackle with a 4-inch by 4-inch selector AND SQUABS-TRADITIONAL INSPECTION PRO- (or kickout), a 45 degree bend of the CEDURES lower 2 inches, an extended central loop portion of the shackle that lowers Number Birds the abdominal cavity opening of the of in- per in- Line configuration 1 spector carcasses to an angle of 30 degrees from spection per stations minute the vertical in direct alignment with the inspector’s view, and a width of 10.5 6–1 ...... 1 25 inches. Maximum rates for those estab- 12–1 ...... 2 23 12–2 ...... 2 21 lishments having varying configura- 18–1 ...... 3 19 tions will be established by the Admin- 18–2 ...... 3 19 istrator but will not exceed those in 18–3 ...... 3 18 the table. Neither the rates in the table 24–1 ...... 4 161⁄2 24–2 ...... 4 16 nor those established for establish- 24–4 ...... 4 151⁄2 ments with varying configurations 1 Birds are suspended on the slaughter line at 6–inch inter- shall be exceeded under any cir- vals. The first number indicates the interval in inches between cumstances. the birds that each inspector examines. The second number indicates how many of the birds presented, the inspector is to (b) There are two categories of tur- inspect, i.e., ‘‘1’’ means inspect every bird. ‘‘4’’ means inspect keys for determining inspection rates, every fourth bird, etc. ‘‘light turkeys’’ and ‘‘heavy turkeys’’. [47 FR 23435, May 28, 1982, as amended at 66 Light turkeys are all turkeys weighing FR 22905, May 7, 2001] less than 16 pounds. Heavy turkeys are all turkeys weighing 16 pounds or § 381.68 Maximum inspection rates— more. The weights refer to the bird at New turkey inspection system. the point of post-mortem inspection, (a) The maximum inspection rates with blood, feathers and feet removed. for one inspector New Turkey Inspec- (c) The inspector in charge may re- tion (NTI–1 and NTI–1 Modified) and duce inspection line rates when in his/ two inspectors New Turkey Inspection her judgment the prescribed inspection (NTI–2 and NTI–2 Modified) are listed procedure cannot be adequately per- in the table below. The line speeds for formed within the time available be- NTI–1 and NTI–2 are for lines using cause the health conditions of a par- standard 9-inch shackles on 12-inch ticular flock or other factors, including centers with birds hung on every the manner in which birds are being shackle and opened with J-type or Bar- presented to the inspector for inspec- type opening cuts. The line speeds for tion and the level of contamination NTI–1 Modified and NTI–2 Modified are among the birds on the line, dictate a for Bar-type cut turkey lines using a need for a more extended inspection.

MAXIMUM TURKEY INSPECTION RATES

Birds/minute Line configura- Number of J-Type Bar-Type Inspection system tion inspectors (<16#) (>16#) 1 (<16#) (>16#) 1 light heavy light heavy

NTI–1 ...... 12–1 1 32 30 25 21 NTI–2 ...... 2 24–2 2 51 41 45 35 NTI–1 Modified ...... 12–1 1 — — 32 30 NTI–2 Modified ...... 2 24–2 2 — — 51 41

1 This weight refers to the bird at the point of post-mortem inspection without blood or feet. 2 The turkeys are suspended on the slaughter line at 12-inch intervals with two inspectors each looking at alternating birds at 24-inch intervals.

[50 FR 37512, Sept. 16, 1985, as amended at 73 FR 51902, Sept. 8, 2008]

EDITORIAL NOTE: At 75 FR 27926, May 19, 2010, § 381.68(a) was amended in the second sentence by removing ‘‘10.5’’ and adding in its place ‘‘10’’; however, the amendment could not be incorporated because ‘‘10.5’’ does not exist in that sentence.

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Subpart J—Ante Mortem (c) All seriously crippled ratites and Inspection non-ambulatory ratites, commonly termed ‘‘downers,’’ shall be identified § 381.70 Ante mortem inspection; when as ‘‘U.S. Suspects.’’ required; extent. (d) Ratites exhibiting signs of drug or chemical poisoning shall be withheld (a) An ante mortem inspection of from slaughter. poultry shall, where and to the extent (e) Ratites identified as ‘‘U.S. Sus- considered necessary by the Adminis- pects’’ or ‘‘U.S. Condemned’’ may be trator and under such instructions as set aside for treatment. The ‘‘U.S. Sus- he may issue from time to time, be pect’’ or ‘‘U.S. Condemned’’ identifica- made of poultry on the day of slaugh- tion device will be removed by an es- ter in any official establishment. tablishment employee under FSIS su- (b) The examination and inspection pervision following treatment if the of ratites will be on the day of slaugh- bird is found to be free of disease. Such ter, except: a bird found to have recovered from the (1) When it is necessary for humane condition for which it was treated may reasons to slaughter an injured animal be released for slaughter or for pur- at night or on a Sunday or holiday, and poses other than slaughter, provided the FSIS veterinary medical officer that in the latter instance permission cannot be obtained; or is first obtained from the local, State, (2) In low volume establishments, or Federal sanitary official having ju- when ante mortem inspection cannot risdiction over movement of such birds. be done on the day of slaughter, and (f) When it is necessary for humane the birds to be slaughtered have re- reasons to slaughter an injured ratite ceived ante mortem inspection in the at night or Sunday or a holiday, and last 24 hours, provided the establish- the Agency veterinary medical officer ment has an identification and control cannot be obtained, the carcass and all system over birds that have received parts shall be kept for inspection, with ante mortem inspection. the head and all viscera except the gas- [37 FR 9706, May 16, 1972, as amended at 66 trointestinal tract held by the natural FR 22906, May 7, 2001] attachment. If all parts are not so kept for inspection, the carcass shall be con- § 381.71 Condemnation on ante demned. If on inspection of a carcass mortem inspection. slaughtered in the absence of an in- (a) Birds plainly showing on ante spector, any lesion or other evidence is mortem inspection any disease or con- found indicating that the bird was sick dition, that under §§ 381.80 to 381.93, in- or diseased, or affected with any other clusive, would cause condemnation of condition requiring condemnation of their carcasses on post mortem inspec- the animal on ante mortem inspection, tion, shall be condemned. Birds which or if there is lacking evidence of the on ante mortem inspection are con- condition that rendered emergency demned shall not be dressed, nor shall slaughter necessary, the carcass shall they be conveyed into any department be condemned. Ratites that are sick, of the official establishment where dying, or that have been treated with a poultry products are prepared or held. drug or chemical and presented for Poultry which has been condemned on slaughter before the required with- ante mortem inspection and has been drawal period, are not covered by emer- killed or died otherwise shall under the gency slaughter provisions. supervision of an inspector of the In- [37 FR 9706, May 16, 1972, as amended at 66 spection Service, be disposed of as pro- FR 22906, May 7, 2001; 67 FR 13258, Mar. 22, vided in § 381.95. 2002] (b) Dead-on-arrival ratites and ratites condemned on ante mortem in- § 381.72 Segregation of suspects on spection will be tagged ‘‘U.S. Con- ante mortem inspection. demned’’ by an establishment em- (a) All birds, except ratites, that on ployee under FSIS supervision and dis- ante mortem inspection do not plainly posed of by one of the methods pre- show, but are suspected of being af- scribed in § 381.95. fected with, any disease or condition

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that under §§ 381.80 to 381.93 of this Part mortem inspection pursuant to the reg- may cause condemnation in whole or in ulations. part on post mortem inspection, shall (b) If it is determined by a veterinary be segregated from the other poultry inspector that further handling of the and held for separate slaughter, evis- poultry will create a health hazard, ceration, and post mortem inspection. such poultry may be released for treat- The inspector shall be notified when ment under the control of an appro- such segregated lots are presented for priate State or Federal agency. If the post mortem inspection, and inspection circumstances are such that release for of such birds shall be conducted sepa- treatment is impracticable, a careful rately. Such procedure for the correla- bird-by-bird ante mortem inspection tion of ante mortem and post mortem shall be made, and all birds found to findings by the inspector, as may be be, or which are suspected of being, af- prescribed or approved by the Adminis- fected with a contagious disease trans- trator, shall be carried out. missible to man shall be condemned. (b) All ratites showing symptoms of disease will be segregated, individually § 381.74 Poultry suspected of having tagged as ‘‘U.S. Suspects’’ by establish- biological residues. ment personnel under FSIS supervision When any poultry at an official es- with a serially numbered metal or plas- tablishment is suspected of having tic leg band or tag bearing the term been treated with or exposed to any ‘‘U.S. Suspect,’’ and held for further substance that may impart a biological examination by an FSIS veterinarian. residue that would make their edible Depending upon the findings of the vet- tissues adulterated, they shall, at the erinarian’s examination, these birds option of the operator of the establish- will either be passed for regular slaugh- ment, be processed at the establish- ter, slaughtered as suspects, withheld ment and the carcasses and all parts from slaughter, or condemned on ante thereof retained under U.S. Retained mortem. Those ratites affected with tags, pending final disposition in ac- conditions that would be readily de- cordance with § 381.80, of this part, and tected on post mortem inspection need other provisions in subpart K; or they not be individually tagged on ante shall be slaughtered at the establish- mortem inspection with the ‘‘U.S. Sus- ment and buried or incinerated in a pect’’ tag provided that such ratites manner satisfactory to the inspector. are segregated and otherwise handled Alternatively, such poultry may be reas ‘‘U.S. Suspects.’’ All ratites identi- turned to the grower, if further holding fied as ‘‘U.S. Condemned’’ shall be is likely to result in their not being tagged by establishment personnel, adulterated by reason of any residue. under FSIS supervision, with a serially The Inspection Service will notify the numbered metal or plastic leg band or other Federal and State agencies con- tag bearing the term ‘‘U.S. Con- cerned of such action. To aid in deter- demned.’’ mining the amount of residue present in the poultry, officials of the Inspec- [66 FR 22906, May 7, 2001] tion Service may permit the slaughter § 381.73 Quarantine of diseased poul- of any such poultry for the purpose of try. collecting tissues for analysis of the residue. Such analysis may include the If live poultry, which is affected by use of inplant screening procedures de- any contagious disease which is trans- signed to detect the presence of anti- missible to man, is brought into an of- microbial residues in any species of ficial establishment, such poultry shall poultry. be segregated. The slaughtering of such poultry shall be deferred and the poul- [47 FR 41336, Sept. 20, 1982] try shall be dealt with in one of the following ways: § 381.75 Poultry used for research. (a) If it is determined by a veterinary (a) No poultry used in any research inspector that further handling of the investigation involving an experi- poultry will not create a health hazard, mental biological product, drug, or the lot shall be slaughtered separately, chemical shall be eligible for slaughter subject to ante mortem and post at an official establishment unless the

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operator of such establishment, the Line Speed (NELS) Inspection System, sponsor of the investigation, or the in- both of which shall be used only for vestigator has submitted to the Inspec- broilers and cornish game hens; the tion Service, or the Veterinary Bio- New Turkey Inspection (NTI) System, logics unit of Veterinary Services, Ani- which shall be used only for turkeys; mal and Plant Health Inspection Serv- Traditional Inspection; and Ratite In- ice of the Department or the Environ- spection. mental Protection Agency, or the Food (i) The SIS shall be used only for and Drug Administration of the De- broilers and cornish game hens if: partment of Health, Education, and (a) The Administrator determines Welfare, data or a summary evaluation that SIS will increase inspector effi- of the data which demonstrates that ciency; or the use of such biological product, drug, or chemical will not result in the (b) The operator requests SIS and the products of such poultry being adulter- Administrator determines that the sys- ated, and the Administrator has ap- tem will result in no loss of inspection proved such slaughter. efficiency. (ii) The NELS Inspection System [37 FR 9706, May 16, 1972, as amended at 39 shall be used only for broilers and cor- FR 4569, Feb. 5, 1974] nish game hens if: (a) The operator requests the NELS Subpart K—Post Mortem Inspec- Inspection System, and tion; Disposition of Carcasses (b) The Administrator determines and Parts that the establishment has the intent and capability to operate at line speeds § 381.76 Post-mortem inspection, when required; extent; traditional, greater than 70 birds per minute, and Streamlined Inspection System meets all the facility requirements in (SIS), New Line Speed (NELS) In- § 381.36(d). spection System and the New Tur- (iii) The NTI System shall be used key Inspection (NTI) System; rate of only for turkeys if: inspection. (a) The operator requests it, and (a) A post-mortem inspection shall be (b) The Administrator determines made on a bird-by-bird basis on all that the establishment meets all the poultry eviscerated in an official estab- facility requirements in § 381.36(e). lishment. No viscera or any part there- (iv) Traditional inspection shall be of shall be removed from any poultry used for turkeys when the NTI System processed in any official establishment, is not used. For other classes of poul- except at the time of post-mortem in- try, Traditional Inspection shall be spection, unless their identify with the used when neither the SIS nor the rest of the carcass is maintained in a NELS Inspection System is used. manner satisfactory to the inspector (2) The requirements of paragraph (a) until such inspection is made. Each carcass to be eviscerated shall be of this section are applicable to all four opened so as to expose the organs and inspection systems. the body cavity for proper examination (3) The following requirements are by the inspector and shall be prepared applicable to SIS: immediately after inspection as ready- (i) Definitions. For purposes of this to-cook poultry. If a carcass is frozen, paragraph, the following definitions it shall be thoroughly thawed before shall apply: being opened for examination by the (a) Cumulative sum (CUSUM). A sta- inspector. Each carcass, or all parts tistical concept used by the establish- comprising such carcass, shall be ex- ment and monitored by the inspector amined by the inspector, except for whereby compliance is determined parts that are not needed for inspec- based on sample results collected over tion purposes and are not intended for a period of time. For purposes of deter- human food and are condemned. mining compliance with the finished (b)(1) There are five systems of post- product standards, the CUSUM is equal mortem inspection: Streamlined In- to the sum of prior test results plus the spection System (SIS) and the New weighted result of the current test

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minus the tolerance, with the condi- ment provide one inspection station for tion that the resulting CUSUM cannot each line and adequate reinspection fa- go below zero. cilities so carcasses can be removed (b) Tolerance number. A weighted from each line for evaluation. The measure that equates to product being maximum line speed for SIS–1 is 35 produced at a national product quality birds per minute. SIS–2 requires that level. See Table 2. the establishment provide two inspec- (c) Action number. A level reached by tion stations for each line and ade- the CUSUM where the process is out of quate reinspection facilities so car- control and product action is required casses can be removed from each line by the establishment or the inspector. for evaluation. The maximum line See Table 2. speed for SIS–2 is 70 birds per minute. (d) ‘‘Start number’’. A value halfway (c) Under all inspection systems, in- between zero and the action number. cluding SIS, inspectors conduct post- The start number is used to determine mortem inspection and look for a num- the starting CUSUM for the first sub- ber of conditions, as specified else- group of a shift and to reset the where in this subpart, which may indi- CUSUM value if the CUSUM is equal to cate adulteration. Adulterated product or greater than the action number. See is condemned and destroyed, except Table 2. that carcasses and parts which may be (e) Subgroup. A 10-bird sample col- made unadulterated by reprocessing lected before product enters the chiller (reworking) may be so reprocessed and after product leaves the chiller. under the supervision of an inspector (f) Subgroup absolute limit. The toler- and reinspected. Under SIS, inspectors ance number plus 5. See Table 2. also reinspect product by sampling fin- (g) Prechill testing. Testing conducted ished birds (both before and after by the establishment to determine the chilling) for nonconformances with fin- CUSUM on consecutive 10-bird sub- ished product standards (see Table 1). If group samples collected prior to prod- such nonconformances are present at uct entering the chilling system. certain statistical levels, it may indi- (h) Postchill testing. Testing con- cate process difficulties requiring cor- ducted by the establishment to deter- rective action by the establishment. If mine the CUSUM on consecutive 10- the establishment does not take ade- bird subgroup samples collected as the quate corrective action, the inspector product leaves the chilling system. shall initiate corrective actions such as (i) Rework. Reprocessing the product conducting closer post-mortem inspec- to correct the condition or conditions tions and requiring reprocessing and causing the nonconformances listed in reinspection of previously processed Table 1. carcasses and parts. Thus, SIS is con- (ii) General. (a) Under SIS, one in- ducted in two phases—a post-mortem spector inspects the outside, inside, inspection phase and a reinspection and viscera of each bird. There may be phase. The following paragraphs de- two inspectors on one processing line, scribe the inspection requirements (not each inspecting every other bird. For addressed elsewhere in this subpart) the establishment to run its processing under each. line(s) at maximum speed, optimal con- (iii) Post-mortem inspection. (a) Facili- ditions must be maintained so that in- ties: Each inspection station must spection may be conducted efficiently. comply with the facility requirements The inspector in charge determines the in § 381.36(c). speed at which each processing line (b) Presentation: Each inspector shall may be operated to permit inspection. be flanked by an establishment em- A variety of conditions may affect this ployee assigned to be the inspector’s determination including the health of helper. The one inspector on the SIS–1 each flock and the manner in which line shall be presented every bird. Each birds are being presented to the inspec- inspector on the SIS–2 line shall be pre- tor for inspection. sented every other bird on the line. An (b) SIS may be performed by one in- establishment employee shall present spector (SIS–1) or two inspectors (SIS– each bird to the inspector properly 2). SIS–1 requires that the establish- eviscerated with the back side toward

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the inspector and the viscera uniformly (5) Hangback racks designed to hold trailing or leading. Each inspector 10 carcasses shall be provided for and shall inspect the inside, viscera, and positioned within easy reach of the per- outside of all birds presented. son at the station. (c) Disposition: The inspector shall (b) Disposition: An inspector shall determine which birds shall be monitor the establishment’s applica- salvaged, reprocessed, condemned, re- tion of the Finished Product Standards tained for disposition by the veteri- program and shall take corrective ac- narian, or allowed to proceed down the tion including retaining product to pre- line as a passed bird subject to trim vent adulterated product from leaving and reinspection. Carcasses with cer- the establishment when the inspector tain defects not requiring condemna- determines that the establishment has tion of the entire carcass shall be failed to apply the program as pre- passed by the inspector, but shall be scribed in paragraph (b)(3)(iv)(c) of this subject to reinspection to ensure the section). physical removal of the defects. The (c) Finished Product Standards: Fin- helper, under the supervision of the in- ished Product Standards (FPS) are cri- spector, shall mark such carcasses for teria applied to processed birds before trim when the defects are not readily and after chill to ensure that the prod- observable. Trimming of birds passed uct being produced is consistently subject to reinspection shall be per- wholesome and unadulterated. These formed by: criteria consist of nonconformances (1) The helper, time permitting, and (listed in Table 1), the incidence of (2) One or more plant trimmers posi- which is determined from 10 bird sub- tioned after all giblets are harvested group samples, reduced to a CUSUM and prior to reinspection. number, and measured against the (iv) Reinspection. (a) Facilities: Rein- standards (Table 2). The standards are spection stations are required at both applied to permit the Agency to esti- the prechill and postchill locations. mate when the production process is in The Agency will determine the number control and when it is out of control. of stations needed in those establish- The establishment is responsible for ments having more than one processing maintaining FPS which, in turn, is line or more than one chiller. One or monitored by the inspector. FPS is ap- more prechill reinspection stations plied in two separate parts. The first is shall be conveniently located at the called prechill testing. It is designed to end of the line or lines prior to ensure that the slaughter and eviscera- chilling. One or more postchill stations tion procedures are in control. Compli- must be conveniently located at the ance is measured by determining the end of the chiller or chillers. The CUSUM on consecutive 10-bird sub- prechill and postchill reinspection sta- group samples collected prior to prod- tions must meet the following provi- uct entering the chilling system. The sions: second part of the FPS is called (1) Floor space shall consist of 3 feet postchill testing. It is designed to mon- along each conveyor line. The space itor the production through the chill shall be level and protected from all system to ensure that it meets the traffic and overhead obstructions. postchill FPS. This test is independent (2) A table at least 2 feet wide and 2 of the prechill test. Compliance is feet deep and 3 feet in height designed measured by determining the CUSUM to be readily cleanable and drainable on consecutive 10-bird subgroup sam- shall be provided for reinspecting the ples as they exit the chilling system. sampled birds. When the system is operating within (3) A minimum of 200 foot-candles of compliance, the establishment applies shadow-free lighting with a minimum the FPS to product samples at the color rendering index of 85 on the table prechill reinspection station. Testing surface. time and time between tests are such (4) A separate clip board holder shall that birds represented by the test are be provided for holding the recording still within the chiller. If an out-of- sheets. compliance condition is found, the

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product leaving the chiller is seg- shift on the evisceration line. In estab- regated for rework and retested before lishments that have multiple eviscera- it may proceed into commerce. A section lines on a production shift, mon- ond 10 bird subgroup sample of the itor all lines of product at the random birds is taken after they leave the times. chiller to ensure that the product (B) Collect the subgroup samples to meets the postchill FPS. Since the be monitored at preselected times. All product is closer to the end of proc- 10 samples of the subgroup shall be col- essing, the controls on releasing re- lected at the random time selected in worked product are stricter than con- paragraph (b)(3)(iv)(d)(1)(ii)(A) of this trols under prechill testing, again to section. ensure that no adulterated product en- (C) Conduct the 10-bird monitoring ters into commerce. subgroup test. (d) Prechill testing. The prechill FPS (2) Actions to be taken when the sub- have been divided into processing and group absolute limit is exceeded. If either trim categories. The processing cat- an inspector or establishment subgroup egory is designed to monitor the out- test exceeds the subgroup absolute put of the dressing and evisceration limit of tolerance plus 5 (T+5), the es- procedures. The trim category mon- tablishment shall determine if any of itors the establishment’s ability to re- the immediate past 5 plant prechill move unwholesome lesions and condi- subgroups for that category (processing tions from inspected and passed car- or trim) resulted in a CUSUM above casses. Each category is monitored the start number. independently of the other category using a separate CUSUM for each cat- (i) If all of the past 5 plant prechill egory. subgroups are at or below the start (1) Actions to be taken when the process number, the establishment shall imme- is in control. If the CUSUM is less than diately conduct a retest subgroup on the action number and the subgroup that category of prechill to determine absolute limit is not exceeded, the sample validity. If retest subgroup process is judged to be in control. total equals tolerance or less, the es- (i) Establishment Actions. The estab- tablishment resumes random time test- lishment shall: ing. If the retest subgroup total ex- (A) Randomly select and record sub- ceeds tolerance, the establishment group sampling times for each produc- shall proceed as if CUSUM reaches the tion unit of time before product action number and shall begin process reaches the prechill reinspection sta- actions as set forth in paragraph tion on the production line. In no case (b)(3)(iv)(d)(4) of this section. In either shall the time between tests exceed 1 case, the prechill retest results will be hour of production time. used to calculate CUSUM. (B) Conduct a 10-bird subgroup test (ii) If any of the past 5 plant prechill at a random time on each poultry subgroups resulted in a CUSUM above slaughter line. These times are the start number, the establishment preselected by the establishment and shall proceed as if CUSUM reaches the available to the inspector prior to the action number and shall begin process start of the shift/day’s operations. All actions as set forth in paragraph 10 samples of the subgroup shall be col- (b)(3)(iv)(d)(4) of this section. lected at the random time. (3) Actions to be taken when a (C) Obtain the weighted value of each trimmable lesion/condition is found. If ei- nonconformance by multiplying the ther inspection or plant monitoring number recorded for each nonconform- finds any trimmable lesion or condi- ance by the ‘‘factor’’ in Table 1, sum tion as specified in item B(7) of Table 1 the total of all the nonconformances, during a prechill subgroup test, the es- and calculate the CUSUM value for tablishment shall immediately conduct that test. an additional prechill subgroup test for (ii) Inspector Actions. The inspector the same trimmable lesion/condition shall: category. This is a requirement on the (A) Select random times for moni- subgroup testing for the prechill trim toring subgroup tests for each half- nonconformance that is in addition to

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the CUSUM test described in paragraph the production supervisor. The number (b)(3)(iv)(d)(1) of this section. of additional tests at the postchill rein- (i) If no additional item in the same spection station using prechill stand- category is found on retest, the estab- ards is increased as required to include lishment shall resume random time the product in the chiller represented sampling. by this additional prechill test. (ii) If an additional item in the same (E) After two consecutive additional category is found on retest, the estab- prechill subgroup tests result in sub- lishment shall proceed as if CUSUM group totals equal to or less than toler- reaches the action number and shall ance: initiate corrective action set forth in —Resume random time prechill subparagraph (b)(3)(iv)(d)(4) of this section group testing as set forth in actions to for this category only. be taken when the process is in control (4) Actions to be taken when the at paragraph (b)(3)(iv)(d)(1) of this sec- CUSUM reaches the action number. Once tion. CUSUM reaches the action number, the —Identify product entering the chill process is judged to be not in control. system that will mark the end of the (i) Establishment Actions. The estab- retest action upon arrival at the lishment shall: postchill sampling location. Such iden- (A) Immediately notify the inspector tification may include tagging or in charge and the production super- empty space in chillers, depending visor responsible for the affected evis- upon the establishment’s identification ceration line. method. (B) Suspend random time prechill —Once all product identified as need- testing of the affected nonconformance ing retesting has arrived at the category (processing or trim). Suspend postchill sampling location, random random time postchill subgroup testing time postchill FPS testing resumes. when the processing category is the af- —If two consecutive additional fected nonconformance category. prechill subgroup tests demonstrate (C) Conduct subgroup retests on car- process control with subgroup totals casses leaving the chill system. Apply equal to or less than tolerance, but the prechill criteria in Table 1 (A) or they do not cause CUSUM to fall to the (B), depending upon which category start line or below, reset CUSUM at caused the action, and apply prechill the start number. Finished Product Standards as listed in (ii) Inspector Actions. The inspector Table 2 to determine product compli- shall monitor product and process ac- ance. In no case shall the time between tions by making spot-check observa- retests exceed 30 minutes of production tions to ensure that all program re- time. Apply prechill standard criteria quirements are met. at the postchill location after notifying (e) Postchill testing. Postchill sub- the establishment’s production super- groups shall be collected after the visor. If any of these subgroup retests product leaves the chiller but before on product leaving the chill system re- the product is divided into separate sult in a subgroup total exceeding tol- processes. Each bird sampled shall be erance, identify for rework subsequent observed and its conformance measured product at the postchill location. All against the postchill criteria. The sub- noncomplying product will be brought group nonconformance weights shall be into compliance prior to release into totaled and the CUSUM calculated by commerce. Product from the chiller subtracting the tolerance from the sum will continue accumulating for rework of the subgroup total and the starting until a subsequent subgroup test re- CUSUM. sults in a subgroup total equal to or (1) Actions to be taken when the process less than tolerance. is in control. If the CUSUM is less than (D) Conduct additional subgroup the action number and the subgroup tests at the prechill reinspection sta- absolute limit is not exceeded, the tion to determine the adequacy of pro- process is judged to be in control. duction corrective action. If the (i) Establishment Actions. The estab- prechill tests results in a subgroup lishment shall conduct a 10-bird sub- total exceeding the tolerance, notify group test for each chiller system at a

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randomly selected time of production. (D) After two consecutive additional In no case shall the time between tests postchill subgroup tests results in sub- exceed 2 hours of production time. group totals equal to or less than toler- (ii) Inspector Actions. The inspector ance: shall: —Resume random time postchill sub- (A) Select random times for postchill group testing as set forth in actions to monitoring. be taken when the process is in control (B) Monitor each chill system twice at paragraph (b)(3)(iv)(e)(1) of this sec- per shift. tion. (C) Conduct subgroup tests at —If the two consecutive additional preselected random times. postchill subgroup totals equal to or less than tolerance do not cause (2) Actions to be taken when the sub- CUSUM to fall to the start number or group absolute limit is exceeded. If either below, reset CUSUM at the start num- an inspector or establishment subgroup ber. test exceeds the subgroup absolute ( ) Inspector Actions. The inspector limit of tolerance plus 5(T+5), the es- ii shall monitor product and process ac- tablishment shall determine if any of tions to ensure that program require- the last 5 postchill monitoring sub- ments are met. groups resulted in a CUSUM above the (v) When the prechill or postchill start number. product has been identified as having (i) If all of the past 5 postchill moni- been produced when the process was toring subgroups resulted in a CUSUM not in control, additional online sub- at or below the start number, the es- group testing by the establishment is tablishment shall immediately retest a required to determine its conformance subgroup to determine sample validity. to the standard. If any of the addi- If this retest subgroup total exceeds tional plant subgroup testing results in tolerance, the establishment shall pro- a subgroup total exceeding tolerance, ceed as if CUSUM reaches the action offline product corrective actions must number and shall begin process actions take place. The responsibilities of the as set forth in paragraph (b)(3)(iv)(e)(3) establishment and the inspector of this section. change depending on the CUSUM. (ii) If any of the past 5 postchill mon- All corrective actions such as identi- itoring subgroups resulted in a CUSUM fying affected product, segregating above the start number, the establish- product, and maintaining control ment shall proceed as if CUSUM through rework actions are the estab- reaches the action number and shall lishment’s responsibility. Corrective begin process actions as set forth in actions by the inspector depends upon paragraph (b)(3)(iv)(e)(3) of this section. the establishment’s ability to control (3) Actions to be taken when the rework of affected product. If the es- CUSUM reaches the action number. Once tablishment fails in its responsibilities, CUSUM reaches the action number, the the inspector will identify, segregate, process is judged to be not in control. and retain affected product to prevent (i) Establishment Actions. The estab- adulterated product from reaching con- lishment shall: sumers. (A) Notify the inspector in charge (a) Offline product. The establish- and the production supervisor respon- ment shall identify the affected prod- sible for product in the chiller. uct so that it may be segregated and (B) Suspend random time postchill accumulated offline for rework. The in- subgroup testing. spector shall spot check the establish- (C) Immediately conduct an addi- ment’s identification, segregation, and tional postchill subgroup test. If the control of reworked product to ensure retest subgroup total exceeds toler- that program requirements are met. ance, the establishment shall identify (b) Reworked product. Reworked subsequent product for rework. Prod- product must be tested by the estab- uct will continue accumulating for re- lishment with a randomly selected sub- work until a subsequent subgroup test group test of the accumulated re- results in a subgroup total equal to or worked lot. Before product is released, less than tolerance. the random subgroup test must result

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in a subgroup total equal to or less TABLE 1—DEFINITIONS OF NONCONFORMANCES— than tolerance. If the subgroup test of Continued a reworked lot results in a subgroup —A maximum of two incidents per carcass. total exceeding tolerance, the lot must 4 Oil glands remnant—less than two whole be reworked again before another sub- glands group is selected. The following actions —Recognizable fragment(s) of one or are required. both oil glands equals one incident. (1) Establishment Actions. The estab- —Factor is one. lishment shall: —Maximum of one incident per carcass. (i) Select the random subgroup from 5 Oil glands—two whole glands —Both whole oil glands with no missing throughout the lot only after the total fragments equals one incident. If the lot has been reworked. oil glands are cut, but no fragment is (ii) Conduct the subgroup test using removed, consider them to be whole. the same criteria (prechill or postchill) But if even a small fragment is re- that resulted in the rework action. moved, use line 4. (iii) Release the lot if the reworked —Factor is two. subgroup test resulted in a subgroup —A maximum of one incident per carcass. total equal to or less than tolerance. 6 Lung ≥1⁄4″ whole (iv) Identify and control the lot to be —Any portion less than a whole lung, reworked if the reworked subgroup and equal to or greater than 1⁄4″ at the total again exceeds tolerance. greatest dimension, equals one inci- (2) Inspector Actions: The inspector dent. shall spot check the rework procedure —Factor is one. to ensure that plant monitoring and —A maximum of two incidents per carcass. production meet the requirements of 7 Lung—whole the program. —Each whole lung equals one incident. (vi) After the 10 bird subgroup tests —Factor is two. are completed, the prechill and —A maximum of two incidents per car- postchill processing nonconformances cass. shall be corrected on all bird samples 8 Intestine prior to returning the samples to the —Any identifiable portion of the terminal portion of the intestinal tract product flow. Samples with trim with a lumen (closed circle) present, nonconformances shall be returned to or split piece of intestine large enough the trim station for correction prior to to be closed to form a lumen. their return to the product flow. —Factor is five. —A maximum of one incident per car- TABLE 1—DEFINITIONS OF NONCONFORMANCES cass. A Processing Nonconformances 9 Cloaca 1 Extraneous material ≤1⁄16″ —Any identifiable portion of the ter- —Include any specks, tiny smears, or minal portion of the intestinal tract with mucosal lining. stains of material that measure 1⁄16″ or less in the greatest dimension. —Factor is five. Examples: Ingesta, unattached feathers, —A maximum of one incident per car- grease, bile remnants, and/or whole cass. gall bladder or spleen, embryonic 10 Bursa of Fabricius yolk, etc. —A whole rosebud, or identifiable portion with two or more mucosal folds. —Factor is one. —Factor is two. —1 to 5=1 defect: 6 to 10=2 defects; 11 or —A maximum of one incident per car- more=3 defects. A maximum of three cass. incidents per carcass. 11 Esophagus 1 ″ ″ 2 Extraneous material > ⁄16 to 1 —Any portion of the esophagus with —The same material as line 1, but meas- identifiable mocosal lining. 1 ″ ″ uring > ⁄16 to 1 in the longest dimen- —Factor is two. sion. —A maximum of one incident per car- —Factor is one. cass. —A maximum of three incidents per 12 Crop—partial—with mucosa carcass. —Any portion of the crop that includes 3 Extraneous material >1″ the mucosal lining. —The same material as lines 1 to 2, but —Factor is two. measuring greater than one inch. —A maximum of one incident per car- —Factor is two. cass. 459

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TABLE 1—DEFINITIONS OF NONCONFORMANCES— TABLE 1—DEFINITIONS OF NONCONFORMANCES— Continued Continued 13 Crop—whole —A maximum of one incident per car- —Any complete crop. cass. —Factor is five. 3 Bruise 1⁄2″ to 1″ —A maximum of one incident per car- —Blood clumps or clots in the super- cass. ficial layers of tissue, skin, muscle or 14 Trachea ≤1″ loose subcutaneous tissue may be slit —Identifiable portion of trachea less and the blood completely washed out. than or equal to one inch long. When the bruise extends into the —Factor is one. deeper layers of muscle, the affected —A maximum of one incident per car- tissue must be removed. Very small cass. bruises less than 1⁄2″ (dime size) and 15 Trachea >1″ areas showing only slight reddening —Identifiable portion of trachea greater need not be counted as defects. than one inch. —Factor is one. —Factor is two. —A maximum of five incidents per car- —A maximum of one incident per carcass. cass. 4 Bruise >1″ 16 Hair ≥1⁄4″ 26 or more. —Same criteria as in line three, but —Hair which is one-fourth inch long or greater than one inch in greatest di- longer measured from the top of the mension. follicle to the end of the hair. 26 or —Factor is two. more hairs equal one incident. —A maximum of three incidents per —Factor is one. carcass. —A maximum of one incident per car- 5 Bruise black/green 1⁄4″ to 1″ cass. —Bruises 1⁄4″ to 1″ that have changed 17 Feather and/or Pinfeathers ≤1″ from red to a black/blue or green color —Attached feathers or protruding pin- due to age. feathers less than or equal to one inch —Factor is two. long. Scored 5 to 10 per carcass as one —A maximum of three incidents per incident, 11 to 15 per carcass as two carcass. incidents, and 16 or more as three in- 6 Bruise Black/green >1″ cidents. —Same as line 5, but measuring greater —Factor is one. that 1″ in greatest dimension. —A maximum of three incidents per —Factor is five. carcass. —A maximum of two incidents per car- 18 Feathers >1″ cass. —Attached feathers longer than one 7 Trimmable lesions/Condition inch. Scored 1 to 3 per carcass as one —A trimmable tumor or identifiable incident 4 to 6 per carcass as two inci- portion of a tumor on any part of the dents, and 7 or more as three inci- carcass. dents. —Trimmable Synovitis/airsacculitis —Factor is one. (saddle/frog) lesions that have not —A maximum of three incidents per been removed. carcass. —Lesion/condition subject to removal 19 Long Shank—both condyles covered following an approved cleanout proc- —If the complete tibiotarsal joint is ess. Examples: airsacculitis, salpin- covered, it equals one incident. gitis, nephritis, spleen, or liver condi- —Factor is two. tions requiring removal of the kid- —A maximum of two incidents per car- neys. cass. Note: All establishments shall develop and B Trim nonconformances maintain a permanent marking system 1 Breast blister that identifies carcasses with removable —Inflammatory tissue, fluid, or pus be- lesions/conditions on the inside surfaces. tween the skin and keel must be When removable lesions/conditions are trimmed if membrane ‘‘slips’’ or if identified inside the carcass by the in- firm nodule is greater than 1⁄2″ in di- spector, the helper will be notified to ameter (dime size). apply the permanent mark. When remov- —Factor is two. able inside lesions/conditions are found on —A maximum of one incident per car- a subgroup sample without the permanent cass. mark, the error is not recorded in line 7. 2 Breast blister—partially trimmed The affected carcass(s) will be hungback —All inflammatory tissue, including for IIC disposition and corrective action. that which adheres tightly to the keel —Factor is five. bone, must be removed. —A maximum of one incident per car- —Factor is two. cass. 460

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TABLE 1—DEFINITIONS OF NONCONFORMANCES— TABLE 1—DEFINITIONS OF NONCONFORMANCES— Continued Continued 8 Failure to complete task as indicated by —A maximum of one incident per car- marking system. cass. Example: Synovitis, airsacculitis, in- 14 External mutilation flammatory process, contamination, —Mutilation to the skin and/or muscle etc. that is caused by the slaughter, dress- —The helper, under the inspector’s di- ing or eviscerating processes. Skinned rection, will apply a mark to the car- elbows (bucked wings) do not trim re- cass, indicating to the trimmer(s) quire unless affected wing joint cap- that specific action must be taken on sule is also opened. that carcass. When airsac and kidney —Factor is one. cleanout, or synovitis part removal, —A maximum of three incidents per or carcass removal from the line is carcass. not completed, or only partially com- C Postchill nonconformances—(Designed pleted, this occurrence is recorded as to monitor those nonconformances added one defect. to product during the chilling process) —Factor is five. It will also be recorded 1 Extraneous material ≤1⁄16″ as a line 7 defect for a total factor of —Include specks, grease, or unidentifi- 10. able foreign material that measure —A maximum of one incident per car- 1⁄16″ or less in the greatest dimension. cass. —Example: Ingesta, grease, or uniden- 9 Compound fracture tifiable foreign material. —Any bone fracture (i.e., leg or wing) —Factor is one. that has caused an opening through —3 to 7=1 defect; 8 to 12=2 defects; 13 or the skin. May be accompanied with a more=3 defects. A maximum of three bruise, but not always. Do not count incidents per carcass. the bruise in line 3 or 4 if it is associ- 2 Extraneous material >1⁄16″ to 1″ ated with the compound fracture. —This includes ingesta, grease, or un- —Factor is two. identifiable foreign material —A maximum of three incidents per measureing >1⁄16″ to 1″ longest dimen- carcass. sion. 10 Wingtip compound fracture —Factor is one. —Same criteria as line 9, but only for —A maximum of three incidents per wingtips. carcass. Note: Bruises not associated with the 3 Extraneous material >1″ fracture should be recorded in the —The same material as line 2, but meas- appropriate lines. uring greater than one inch. —Factor is one. —Factor is two. —A maximum of two incidents per car- —A maximum of two incidents per carcass. cass. 11 Untrimmed short hock —When no cartilage of the hock surface TABLE 2—FINISHED PRODUCT STANDARDS is present and no tendons are attached to the bone. SIS —Factor is two. —A maximum of two incidents per car- Prechill Processing Nonconformance cass. Tolerance number (T) ...... 25 12 Sores, scabs, inflammatory process, etc. Subgroup Absolute Limit (T+5) ...... 30 ≤1⁄2″ Action number ...... 22 —Any defects such as sores, abscesses, Start number ...... 11 scabs, wounds, dermatitis, inflam- Prechill Trim Nonconformance matory process, that measure less Tolerance number (T) ...... 12 than or equal to 1⁄2″ in the greatest di- Subgroup Absolute Limit (T+5) ...... 17 mension. Action number ...... 15 —Factor is two. Start number ...... 8 —A maximum of two incidents per car- Postchill Nonconformance cass. Tolerance number (T) ...... 5 13 Sores, scabs, inflammatory process, etc. Subgroup Absolute Limit (T+5) ...... 10 >1⁄2″ Action number ...... 10 —Same as line 12, but greatest dimen- Start number ...... 5 sion is greater than 1⁄2″, or a cluster of smaller lesions in close proximity (4) The following requirements are >1⁄2″, this category also includes tur- also applicable to NELS inspection: key leg edema. (i) Inspection under NELS is con- —Factor is five. ducted in two phases, as post-mortem 461

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inspection phase and a reinspection each line and adequate reinspection phase. facilitiates so carcasses can be re- (a) Post-mortem inspection. The estab- moved from each line for evaluation. lishment shall provide three inspection The NTI–2 Inspection System requires stations on each eviscerating line in that the establishment provide two in- compliance with the facility require- spection stations for each line and ade- ments § 381.36(d)(1). The three inspec- quate reinspection facilities so car- tors shall inspect the inside, viscera, casses can be removed from each line and outside of all birds presented. Each for evaluation. inspector shall be flanked by two es- (a) Post-mortem inspection. Each in- tablishment employees—the presenter spection station must comply with the and the helper. The presenter shall en- facility requirements in § 381.36(e)(1). sure that the bird is properly evis- Each inspector shall be flanked by and cerated and presented for inspection establishment employee assigned to be and the viscera uniformly trailing or the inspector’s helper. The one inspec- leading. The inspector shall determine tor on an NTI–1 Inspection System which birds shall be salvaged, reproc- shall be presented every bird. Each in- essed, condemned, retained for disposi- spector on an NTI–2 Inspection System tion by the veterinarian, or allowed to line shall be presented every other bird proceed down the line as a passed bird on the line. An establishment employee subject to reinspection. Poultry car- shall present each bird to the inspector casses with certain defects not requir- properly eviscerated with the back side ing condemnation of the entire carcass toward the inspector and the viscera shall be passed by the inspector, but uniformly trailing or leading. Each in- shall be subject to reinspection to en- spector shall inspect the inside, sure the physical removal of the speci- viscera, and outside of all birds pre- fied defects. The helper, under the su- sented. The inspector shall determine pervision of the inspector, shall mark which bird shall be salvaged, reproc- such carcasses for trim when the de- essed, condemned, retained for disposi- fects are not readily observable. Trim- tion by a veterinarian, or allowed to ming or birds passed subject to rein- proceed down the line as a passed bird spection shall be performed by: subject to reinspection. Turkey car- (1) The helper, time permitting, and casses with certain defects not requir- (2) One or more plant trimmers posi- ing condemnation of the entire carcass tioned after giblet harvest and prior to shall be passed by the inspector, but reinspection. shall be subject to reinspection to en- (b) A reinspection station shall be lo- sure the physical removal of the speci- cated at the end of each line. This sta- fied defects. The helper, under the su- tion shall comply with the facility re- pervision of the inspector, shall mark quirements in § 381.36(d)(2). The inspec- such carcasses for trim when the de- tor shall ensure that the establishment fects of birds passed subject to rein- has performed the indicated trimming spection shall be performed by: of carcasses passed subject to reinspec- (1) The helper, time permitting, and tion by visually monitoring, checking (2) One or more plant trimmers posi- data, or gathering samples at the sta- tioned after the giblet harvest and tion or at other critical points on the prior to reinspection. line. (b) Reinspection. A reinspection sta- (ii)–(iii) [Reserved] tion shall be located at the end of the (iv) The maximum inspection rate for lines. This station shall comply with NELS shall be 91 birds per minute per the facility requirements in eviscerating line. § 381.36(e)(2). The inspector shall ensure (5) The following requirements are that establishments have performed also applicable to the NTI System: the indicated trimming of each carcass (i) Inspection under the NTI System passed subject to reinspection by vis- is conducted in two phases, a post- ually monitoring, checking data, and/ mortem inspection phase and a rein- or sampling product at the reinspec- spection phase. The NTI–1 Inspection tion station and, if necessary, at other System requires that the establish- points, critical to the wholesomeness ment provide one inspection station for of product, on the eviscerating line.

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(ii)–(iii) [Reserved] § 381.80 General; biological residues. (Recordkeeping requirements approved by (a) The carcasses or parts of car- the Office of Management and Budget under casses of all poultry inspected at an of- control number 0583–0008) ficial establishment and found at the [47 FR 23435, May 28, 1982, as amended at 49 time of post mortem inspection, or at FR 42555, Oct. 23, 1984; 50 FR 37513, Sept. 16, any subsequent inspection, to be af- 1985; 50 FR 38097, Sept. 20, 1985; 51 FR 3574, fected with any of the diseases or con- Jan. 29, 1986; 53 FR 46861, Nov. 21, 1988; 62 FR ditions named in other sections in this 5143, Feb. 4, 1997; 65 FR 34390, May 30, 2000; 66 subpart, shall be disposed of in accord- FR 22906, May 7, 2001] ance with the section pertaining to the disease or condition. Owing to the fact § 381.77 Carcasses held for further ex- that it is impracticable to formulate amination. rules for each specific disease or condi- Each carcass, including all parts tions and to designate at just what thereof, in which there is any lesion of stage a disease process results in an disease, or other condition which adulterated article, the decision as to might render such carcass or any part the disposal of all carcasses, organs or thereof adulterated and with respect to other parts not specifically covered by which a final decision cannot be made the regulations, or by instructions of on first examination by the inspector, the Administrator issued pursuant shall be held for further examination. thereto, shall be left to the inspector in The identity of each such carcass, in- charge, and if the inspector in charge is cluding all parts thereof, shall be main- in doubt concerning the disposition to be made, specimens from such car- tained until a final examination has casses shall be forwarded to the Inspec- been completed. tion Service laboratory for diagnosis. § 381.78 Condemnation of carcasses (b) All carcasses, organs, or other and parts: separation of poultry parts of carcasses of poultry shall be suspected of containing biological condemned if it is determined on the residues. basis of a sound statistical sample that they are adulterated because of the (a) At the time of any inspection presence of any biological residues. under this subpart each carcass, or any part thereof, which is found to be adul- § 381.81 Tuberculosis. terated shall be condemned, except that any such articles which may be Carcasses of poultry affected with tu- made not adulterated by reprocessing, berculosis shall be condemned. need not be so condemned if so reproc- § 381.82 Diseases of the leukosis com- essed under the supervision of an in- plex. spector and thereafter found to be not Carcasses of poultry affected with adulterated. any one or more of the several forms of (b) When a lot of poultry suspected of the avian leukosis complex shall be containing biological residues is in- condemned. spected in an official establishment, all carcasses and any parts of carcasses in § 381.83 Septicemia or toxemia. such lot which are condemned shall be Carcasses of poultry showing evi- kept separate from all other con- dence of any septicemic or toxemic dis- demned carcasses or parts. ease, or showing evidence of an abnor- [37 FR 9706, May 16, 1972, as amended at 48 mal physiologic state, shall be con- FR 22899, May 23, 1983; 48 FR 23807, May 27, demned. 1983] § 381.84 Airsacculitis. § 381.79 Passing of carcasses and Carcasses of poultry with evidence of parts. extensive involvement of the air sacs Each carcass and all organs and with airsacculitis or those showing other parts of carcasses which are airsacculitis along with systemic found to be not adulterated shall be changes shall be condemned. Less af- passed for human food. fected carcasses may be passed for food

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after complete removal and condemna- render the carcasses adulterated shall tion of all affected tissues including be condemned. Any organ or other part the exudate. of a carcass which has been acciden- tally multilated in the course of proc- [40 FR 14297, Mar. 31, 1975] essing shall be condemned, and if the § 381.85 Special diseases. whole carcass is affected, the whole carcass shall be condemned. Carcasses of poultry showing evi- (b)(1) Any carcass of poultry acciden- dence of any disease which is charac- tally contaminated during slaughter terized by the presence, in the meat or with digestive tract contents shall not other edible parts of the carcass, or or- be condemned if promptly reprocessed ganisms or toxins dangerous to the under the supervision of an inspector consumer, shall be condemned. and thereafter found not to be adulter- § 381.86 Inflammatory processes. ated. Contaminated surfaces that are cut shall be removed only by trimming. Any organ or other part of a carcass Contaminated inner surfaces that are which is affected by an inflammatory not cut may be cleaned by trimming process shall be condemned and, if alone, or at an approved reprocessing there is evidence of general systemic station away from the main processing disturbance, the whole carcass shall be line, by any method that will remove condemned. the contamination, such as vacuuming, § 381.87 Tumors. washing, and trimming, singly or in combination. All visible specks of con- Any organ or other part of a carcass tamination must be removed, and if which is affected by a tumor shall be the inner surfaces are reprocessed condemned and when there is evidence other than soley by trimming, all sur- of metastasis or that the general condi- faces of the carcass shall be treated tion of the bird has been affected by with chlorinated water containing 20 the size, position, or nature of the ppm available chlorine. tumor, the whole carcass shall be con- (2) An area will be designated as an demned. approved reprocessing station only if the Administrator determines that re- § 381.88 Parasites. processing operations can be conducted Organs or other parts of carcasses in that area in accordance with all of which are found to be infested with the requirements of this part, and that parasites, or which show lesions of the reprocessing methods to be utilized such infestation shall be condemned are capable of removing all visible and, if the whole carcass is affected, specks of contamination on the inner the whole carcass shall be condemned. surface of a carcass. Requests for such approval shall be submitted to the in- § 381.89 Bruises. spector in charge and shall describe the Any part of a carcass which is badly proposed area, proposed methods of re- bruised shall be condemned and, if the processing, and proposed equipment to whole carcass is affected as a result of be utilized. Whenever the Adminis- the bruise, the whole carcass shall be trator finds that reprocessing oper- condemned. Parts of a carcass which ations cannot be conducted in such show only slight reddening from a area in accordance with all of the re- bruise may be passed for food. quirements of this part or that the reprocessing methods utilized are not ca- § 381.90 Cadavers. pable of removing all visible specks of Carcasses of poultry showing evi- contamination on the inner surface of dence of having died from causes other a carcass, he may withdraw approval of than slaughter shall be condemned. such area, effective upon oral or written notification, whichever is earlier, § 381.91 Contamination. to the operator of the establishment. (a) Carcasses of poultry contami- In the event of oral notification, a nated by volatile oils, paints, poisons, written confirmation thereof shall be gases, scald vat water in the air sac given to the operator as promptly as system, or other substances which circumstances permit. The notification

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shall specify the reasons for such with- (2) Sampling requirements. drawal and shall afford the operator of (i) Written procedures. Each establish- the establishment an opportunity to ment shall prepare written specimen present his views. In any instance collection procedures which shall iden- where there is a conflict as to the tify employees designated to collect facts, a hearing shall be held to resolve samples, and shall address location(s) such conflict. of sampling, how sampling randomness [37 FR 9706, May 16, 1972, as amended at 43 is achieved, and handling of the sample FR 12847, Mar. 28, 1978] to ensure sample integrity. The written procedure shall be made available § 381.92 Overscald. to FSIS upon request. Carcasses of poultry which have been (ii) Sample collection. A whole bird overscalded, resulting in a cooked ap- must be taken from the end of the pearance of the flesh, shall be con- chilling process. If this is impracti- demned. cable, the whole bird can be taken from the end of the slaughter line. Samples § 381.93 Decomposition. must be collected by rinsing the whole Carcasses of poultry deleteriously af- carcass in an amount of buffer appro- fected by post mortem changes shall be priate for that type of bird. Samples disposed of as follows: from turkeys or ratites also may be (a) Carcasses which have reached a collected by sponging the carcass on state of putrefaction or stinking fer- the back and thigh. 1 mentation shall be condemned. (iii) Sampling frequency. Slaughter es- (b) Any part of a carcass which is tablishments, except very low volume green struck shall be condemned and, if establishments as defined in paragraph the carcass is so extensively affected (a)(2)(v) of this section, must take sam- that removal of affected parts is im- ples at a frequency proportional to the practicable, the whole carcass shall be establishment’s volume of production condemned. at the following rates: (c) Carcasses affected by types of post (A) Chickens: 1 sample per 22,000 car- mortem change which are superficial casses, but a minimum of one sample in nature may be passed for human during each week of operation. food after removal and condemnation (B) Turkeys, Ducks, Geese, Guineas, of the affected parts. Squabs, and Ratites: 1 sample per 3,000 carcasses, but at a minimum one sam- § 381.94 Contamination with Micro- ple each week of operation. organisms; process control (iv) Sampling frequency alternatives. verification criteria and testing; An establishment operating under a pathogen reduction standards. validated HACCP plan in accordance (a) Criteria for verifying process con- with § 417.2(b) of this chapter may sub- trol; E. coli testing. stitute an alternative frequency for the (1) Each official establishment that frequency of sampling required under slaughters poultry shall test for Esch- paragraph (a)(2)(iii) of this section if, erichia coli Biotype I (E. coli). Establish- (A) The alternative is an integral ments that slaughter more than one part of the establishment’s verification type of poultry and/or poultry and live- procedures for its HACCP plan and, stock, shall test the type of poultry or (B) FSIS does not determine, and no- livestock slaughtered in the greatest tify the establishment in writing, that number. The establishment shall: the alternative frequency is inadequate (i) Collect samples in accordance to verify the effectiveness of the estab- with the sampling techniques, method- lishment’s processing controls. ology, and frequency requirements in paragraph (a)(2) of this section; (ii) Obtain analytic results in accord- 1 A copy of FSIS’s ‘‘Guidelines for Esch- ance with paragraph (a)(3) of this sec- erichia coli Testing for Process Control Verification in Poultry Slaughter Establish- tion; and ments,’’ and ‘‘FSIS Turkey Microbiological (iii) Maintain records of such ana- Procedures for Sponge Sample Collection lytic results in accordance with para- and Methods of Analysis’’ are available for graph (a)(4) of this section. inspection in the FSIS Docket Room.

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(v) Sampling in very low volume estab- analysis of E. coli that is approved as lishments. (A) Very low volume estab- an AOAC Official Method of the AOAC lishments annually slaughter no more International (formerly the Associa- than 440,000 chickens, 60,000 turkeys, tion of Official Analytical Chemists) 2 60,000 ducks, 60,000 geese, 60,000 guin- or approved and published by a sci- eas, 60,000 squabs, 6,000 ratites, or a entific body and based on the results of combination of all types of poultry not a collaborative trial conducted in ac- exceeding 60,000 turkeys and 440,000 cordance with an internationally rec- birds total. Very low volume establish- ognized protocol on collaborative trials ments that slaughter turkeys, ducks, and compared against the three tube geese, guineas, squabs, or ratites in the Most Probable Number (MPN) method largest number must collect at least and agreeing with the 95 percent upper one sample during each week of oper- and lower confidence limit of the ap- ation after June 1 of each year, and propriate MPN index. continue sampling at a minimum of (4) Recording of test results. The estab- once each week the establishment op- lishment shall maintain accurate erates until June of the following year records of all test results, in terms of or until 13 samples have been collected, whichever comes first. CFU/ml of rinse fluid. Results shall be (B) Upon the establishment’s meeting recorded onto a process control chart the requirements of paragraph or table showing at least the most re- (a)(2)(v)(A) of this section, weekly sam- cent 13 test results, by type of poultry pling and testing is optional, unless slaughtered. Records shall be retained changes are made in establishment fa- at the establishment for a period of 12 cilities, equipment, personnel or proce- months and shall be made available to dures that may affect the adequacy of FSIS upon request. existing process control measures, as (5)(i) Criteria for Evaluation of test re- determined by the establishment or by sults. An establishment is operating FSIS. FSIS determinations that within the criteria when the most re- changes have been made requiring recent E. coli test result does not exceed sumption of weekly testing shall be the upper limit (M), and the number of provided to the establishment in writ- samples, if any, testing positive at lev- ing. els above (m) is three or fewer out of (3) Analysis of samples. Laboratories the most recent 13 samples (n) taken, may use any quantitative method for as follows:

TABLE 1—EVALUATION OF E. COLI TEST RESULTS

Maximum Lower limit of Upper limit of Number of number per- Types of poultry marginal range marginal range samples mitted in mar- (m) (M) tested (n) ginal range (c)

Chickens ...... 1 100 1 1,000 13 3 Turkeys ...... *NA *NA *NA *NA Ducks ...... *NA *NA *NA *NA Geese ...... *NA *NA *NA *NA Guineas ...... *NA *NA *NA *NA Squabs ...... *NA *NA *NA *NA Ratites ...... *NA *NA *NA *NA 1 CFU/ml. * Values will be added upon completion of data collection programs.

(ii) For types of poultry appearing in results using statistical process control paragraph (a)(5)(1) Table 1 of this sec- techniques. tion that do not have m/N criteria, es- (6) Failure to meet criteria. Test results tablishments shall evaluate E. coli test that do not meet the criteria described

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in paragraph (a)(5) of this section are section have not been complied with an indication that the establishment and written notice of same has been may not be maintaining process con- provided to the establishment. trols sufficient to prevent fecal con- (b) Pathogen reduction performance tamination. FSIS shall take further ac- standards; Salmonella—(1) Raw poultry tion as appropriate to ensure that all product performance standards for Sal- applicable provisions of the law are monella. (i) An establishment’s raw being met. poultry products, when sampled and (7) Failure to test and record. Inspec- tested by FSIS for Salmonella as set tion will be suspended in accordance forth in this section, may not test posi- with rules of practice that will be tive for Salmonella at a rate exceeding adopted for such proceeding, upon a the applicable national pathogen re- finding by FSIS that one or more production performance standard, as provisions of paragraphs (a) (1)–(4) of this vided in Table 2:

TABLE 2—SALMONELLA PERFORMANCE STANDARDS

Performance Maximum Standard (per- Number of number of Class of product cent positive for samples tested positives to a (n) achieve standard salmonella) (c)

Broilers ...... 20.0% 51 12 Ground chicken ...... 44.6 53 26 Ground turkey ...... 49.9 53 29 Turkeys ...... b NA NA NA Squabs ...... b NA NA NA Ratites ...... b NA NA NA a Performance Standards are FSIS’s calculation of the national prevalence of Salmonella on the indicated raw products based on data developed by FSIS in its nationwide microbiological baseline data collection programs and surveys. (Copies of Reports on FSIS’s Nationwide Microbiological Data Collection Programs and Nationwide Microbiological Surveys used in determining the prevalence of Salmonella on raw products are available in the FSIS Docket Room.) b Not available; baseline targets for turkeys, squabs, or ratites will be added upon completion of the data collection programs for that product.

(2) Enforcement. FSIS will sample and (ii) If the establishment fails to meet test raw poultry products in an indi- the standard on the next series of com- vidual establishment on an unan- pliance tests for that product, the es- nounced basis to determine prevalence tablishment shall reassess its HACCP of Salmonella in such products to deter- plan for that product. mine compliance with the standard. (iii) Failure by the establishment to The frequency and timing of such test- act in accordance with paragraph ing will be based on the establish- (b)(3)(ii) of this section, or failure to ment’s previous test results and other meet the standard on the third con- information concerning the establish- secutive series of FSIS-conducted tests ment’s performance. In an establish- for that product, constitutes failure to ment producing more than one class of maintain sanitary conditions and fail- product subject to the pathogen reduc- ure to maintain an adequate HACCP tion standard, FSIS may sample any or plan, in accordance with part 417 of 3 all such classes of products. this chapter, for that product, and will (3) Noncompliance and establishment cause FSIS to suspend inspection serv- response. When FSIS determines that ices. Such suspension will remain in ef- an establishment has not met the perfect until the establishment submits to formance standard: the FSIS Administrator or his/her des- (i) The establishment shall take im- ignee satisfactory written assurances mediate action to meet the standard. detailing the action taken to correct the HACCP system and, as appropriate, 3 A copy of FSIS’s ‘‘Sample Collection Guidelines and Procedure for Isolation and Identification of Salmonella from Raw Meat and Poultry Products’’ is available for inspection in the FSIS Docket Room.

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other measures taken by the establish- (d) Any other substance or method ment to reduce the prevalence of that the Administrator approves in pathogens. specific cases, which will denature the [61 FR 38866, July 25, 1996, as amended at 62 poultry product to the extent nec- FR 26218, May 13, 1997; 62 FR 61009, Nov. 14, essary to accomplish the purposes of 1997; 64 FR 66553, Nov. 29, 1999; 67 FR 13258, this section. Mar. 22, 2002] (e) Carcasses and parts of carcasses condemned for biological residue shall Subpart L—Handling and Disposal be disposed of in accordance with para- of Condemned or Other Ined- graph (b) of this section or by burying ible Products at Official Estab- under the supervision of an inspector. lishments Subpart M—Official Marks, De- § 381.95 Disposal of condemned poul- vices, and Certificates; Export try products. Certificates; Certification Pro- All condemned carcasses, or con- cedures demned parts of carcasses, or other condemned poultry products, except § 381.96 Wording and form of the offi- those condemned for biological resi- cial inspection legend. dues shall be disposed of by one of the following methods, under the super- Except as otherwise provided in this vision of an inspector of the Inspection subpart, the official inspection legend Service. (Facilities and materials for required to be used with respect to in- carrying out the requirements in this spected and passed poultry products section shall be furnished by the offi- shall include wording as follows: ‘‘In- cial establishment.) spected for wholesomeness by U.S. De- (a) Steam treatment (which shall be partment of Agriculture.’’ This word- accomplished by processing the con- ing shall be contained within a circle. demned product in a pressure tank The form and arrangement of such under at least 40 pounds of steam pres- wording shall be exactly as indicated in sure) or thorough cooking in a kettle the example in Figure 1, except that or vat, for a sufficient time to effec- the appropriate official establishment tively destroy the product for human number shall be shown, and if the es- food purposes and preclude dissemina- tablishment number appears elsewhere tion of disease through consumption by on the labeling material in the manner animals. (Tanks and equipment used prescribed in § 381.123(b), it may be for this purpose or for rendering or pre- omitted from the inspection mark. The paring inedible products shall be in administrator may approve the use of rooms or compartments separate from abbreviations of such inspection mark; those used for the preparation of edible and such approved abbreviations shall products. There shall be no direct con- have the same force and effect as the nection by means of pipes, or otherwise, between tanks containing ined- inspection mark. The official inspec- ible products and those containing edition legend, or the approved abbrevia- ble products.) tion thereof, shall be printed on con- (b) Incineration or complete destruc- sumer packages and other immediate tion by burning. containers of inspected and passed (c) Chemical denaturing, which shall poultry products, or on labels to be se- be accomplished by the liberal applica- curely affixed to such containers of tion to all carcasses and parts thereof, such products and may be printed or of: stenciled thereon, but shall not be ap- (1) Crude carbolic acid, plied by rubber stamping. When applied (2) Kerosene, fuel oil, or used crank- by a stencil, the legend shall not be case oil, or less than 4 inches in diameter. An offi- (3) Any phenolic disinfectant con- cial brand must be applied to inspected forming to commercial standards CS and passed carcasses and parts of 70–41 or CS 71–41 which shall be used in ratites that are shipped unpacked. at least 2 percent emulsion or solution.

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§ 381.97 [Reserved]

§ 381.98 Official seal. The official mark for use in sealing means of conveyance used in transporting poultry products under any requirement in this part shall be the inscription and a serial number as shown below, and any seals approved by the Administrator for applying such mark shall be an official device.

[66 FR 22906, May 7, 2001]

§ 381.99 Official retention and rejection tags. The official marks for use in post- mortem inspection and identification of adulterated products, insanitary equipment and facilities are: (a) A paper tag (a portion of Form MP–35) bearing the legend ‘‘U.S. Re- tained’’ for use on poultry or poultry products under this section. § 381.102 [Reserved] (b) A paper tag (another portion of Form C&MS 510) bearing the legend § 381.103 Official poultry condemna- ‘‘U.S. Rejected’’ for use on equipment, tion certificates; issuance and form. utensils, rooms and compartments Upon request by the operator of the under this section. establishment, the inspector in charge [64 FR 56417, Oct. 20, 1999] shall issue a poultry condemnation certificate (Form MP–514–1), showing the § 381.100 Official detention tag. total number of poultry in the lot and The detention tag prescribed in the numbers condemned and the rea- § 381.211 is an official device. sons for such condemnations. The official poultry condemnation § 381.101 Official U.S. Condemned certificate authorized by this subpart mark. is a paper certificate (Form MP–514–1), The term ‘‘U.S. Condemned’’ as for signature by an inspector, bearing shown below is an official mark and the legend the devices used by the Department for applying such mark are official devices.

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U.S. DEPARTMENT OF AGRICULTURE ANI- export: Provided, that the product is of- MAL AND PLANT HEALTH INSPECTION fered for inspection at an official estab- SERVICE lishment. Each shipping container covered by the export certificate, except POULTRY CONDEMNATION CERTIFICATE ship stores, small quantities exclusively for the personal use of the con- and the seal of the United States De- partment of Agriculture, with a certifi- signee and not for sale or distribution, cation that the poultry enumerated on and shipments by and for the U.S. the form were inspected and con- Armed Forces, shall be marked with an demned for the listed causes in compli- official export stamp as shown in ance with the regulations of the De- § 381.104 bearing the number of the ex- partment. A statement to the effect port certificate. Official export certifi- that certain figures on the certificate cates will be issued only upon condi- were derived from information supplied tion that the products covered thereby by plant management, and a signature shall be subject to reinspection at any line for an authorized plant official is place and at any time prior to expor- also shown. tation to determine the identity of the products and their eligibility for cer- § 381.104 Official export certificates, tification, and such certificates shall marks and devices. become invalid if such reinspection is The form of certificate described in refused or discloses that the products § 381.106 is an official export certificate, are not eligible for certification. If re- and the mark shown below is the offi- inspection discloses that any poultry cial mark used on outside containers to products covered by an export certifi- identify inspected and passed poultry cate are not eligible for such certifi- products for export. Devices used by cation, a superseding certificate set- the Department to apply such a mark ting forth such findings shall be issued are official devices. and copies shall be furnished to interested persons. (b) The original and a duplicate of each official export certificate shall be delivered to the person who requested such certificate or his agent. Such person may duplicate such numbers of exact copies of the original as he requires in connection with the exportation of the poultry products. Addi- tional official file copies of the export certificates shall be prepared and distributed by the inspector in accordance with the instructions of the Adminis- trator. [47 FR 29823, July 9, 1982] (c) Only one certificate shall be issued for each consignment, except in § 381.105 Export certification; marking case of error in the certificate or loss of containers. of the certificate originally issued. A (a) Upon request or application by request for a new certificate, except in any person intending to export any the case of a lost certificate, shall be poultry product, any inspector is au- accompanied by the original and all thorized to issue an official export cer- copies of the first certificate. The new tificate as prescribed in § 381.107 with certificate shall carry the following respect to the shipment to any foreign statement: ‘‘This certificate supersedes country of any inspected and passed certificate No. lll Dated lllll. poultry product, after adequate inspec- The outside container of the poultry tion of the product has been made by product covered by this certificate is the inspector to determine its identity as inspected and passed and eligible for

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stamped with United States Depart- are certified under the regulations in ment of Agriculture Certificate No. part 362 of this chapter. lll.’’ [37 FR 9706, May 16, 1972, as amended at 39 [37 FR 9706, May 16, 1972, as amended at 50 FR 4569, Feb. 5, 1974; 41 FR 23702, June 11, FR 25204, June 18, 1985] 1976]

§ 381.106 Form of official export cer- § 381.108 Official poultry inspection tificate. certificates; issuance and disposi- The official export certificate au- tion. thorized by this subpart is a paper cer- (a) Upon the request of an interested tificate form for signature by an in- party, any veterinary inspector is au- spector, bearing a letterhead and the thorized to issue an official poultry in- seal of the U.S. Department of Agri- culture, with a certification that the spection certificate with respect to any slaughtered poultry and other poultry lot of slaughtered poultry inspected by products described on the form came him. At any official establishment from birds that were officially given an each such certificate shall be signed by ante-mortem and post-mortem inspec- the inspector who made the inspection tion and passed in accordance with the covered by the certificate, and if more regulations of the Department and that than one inspector participated in the such products are wholesome and fit inspection of the lot of poultry, each for human consumption. The certifi- such inspector shall sign the certificate cate also bears a serial number, such as with respect to such lot. If the inspec- ‘‘MPA 002805’’, and shows the respec- tion of a lot covered by a certificate tive names of the exporter and con- was made by a food inspector, such cer- signee, the destination, the shipping tificate shall also be signed by the in- marks, the names of such products, the spector in charge when such inspection total net weight thereof, and such was made. Any inspector is authorized other information as the Adminis- to issue a poultry inspection certificate trator may prescribe or approve in spe- with respect to any other poultry prod- cific cases. uct inspected by him. [47 FR 29823, July 9, 1982] (b) The original and one copy of each poultry inspection certificate shall be § 381.107 Special procedures as to cer- issued to the applicant who requested tification of poultry products for export to certain countries. such certificate, and one copy shall be retained by the inspector for filing. When export certificates are required The inspector who issues any inspec- by any foreign country for poultry tion certificate is authorized to furnish products exported to such country, the an additional copy of such certificate Administrator shall in specific cases prescribe or approve the form of export upon the request of an interested certificate to be used and the methods party. The person who sold the live and procedures he deems appropriate poultry involved to the official estab- with respect to the processing of such lishment is an interested party for pur- products, in order to comply with re- poses of this section. quirements specified by the foreign [37 FR 9706, May 16, 1972, as amended at 39 country regarding the export products. FR 36000, Oct. 7, 1974] Inspectors shall satisfy themselves that all such requirements are met be- § 381.109 Form of official poultry in- fore issuing such an export certificate. spection certificate. It shall be the responsibility of the ex- (a) The official poultry inspection porter to provide any unofficial docu- certificate authorized by this subpart mentation needed to meet the foreign is a paper certificate (Form MP–505) for requirements, before the export certificate will be issued. Such certificates signature by an inspector, bearing the may also cover articles exempted from legend definition as a poultry product under § 381.15 if they have been inspected and

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U.S. DEPARTMENT OF AGRICULTURE ANI- Such device shall be supplied to inspec- MAL AND PLANT HEALTH INSPECTION tors, compliance officers, and other SERVICE MEAT AND POULTRY INSPEC- designated Agency officials by the TION PROGRAM United States Department of Agri- culture. POULTRY INSPECTION CERTIFICATE and the seal of the U.S. Department of Agriculture, with a certification that the poultry described therein had been inspected in compliance with the Regu- lations of the Secretary of Agriculture Governing the Inspection of Poultry and Poultry Products. (b) The certificate also bears a serial number such as ‘‘B 3208’’ and shows the respective name and address of the applicant, the shipper or seller and the [52 FR 41958, Nov. 2, 1987] receiver or buyer and the net weight in pounds of amount passed, amount re- Subpart N—Labeling and jected or condemned, type of poultry, Containers lot number and class, and such other information as the Administrator may § 381.115 Containers of inspected and prescribe or approve in specific cases. passed poultry products required to be labeled. § 381.110 Erasures or alterations made on certificates. Except as may be authorized in spe- Erasures or alterations not initialed cific cases by the Administrator with by the issuing inspector shall not be respect to shipment of poultry prod- permitted on any official certificate or ucts between official establishments, any copy thereof. All certificates ren- each shipping container and each im- dered useless through clerical error or mediate container of any inspected and otherwise and all certificates canceled passed poultry product shall at the for whatever cause shall be voided and time it leaves the official establish- initialed, and one copy shall be re- ment bear a label which contains infor- tained in the inspector’s file; and the mation, and has been approved, in ac- original and all other copies shall be cordance with this subpart. forwarded to the appropriate program supervisor. § 381.116 Wording on labels of immediate containers. § 381.111 Data to be entered in proper spaces. (a) Each label for use on immediate containers for inspected and passed All certificates shall be so executed poultry products shall bear on the prin- that the data entered thereon will ap- cipal display panel (except as otherwise pear in the proper spaces on each copy permitted in the regulations), the of the certificate. items of information required by this § 381.112 Official mark for maintaining subpart. Such items of information the identity and integrity of sam- shall be in distinctly legible form. Ex- ples. cept as provided in § 381.128, all words, The official mark for use in sealing statements and other information re- containers of samples submitted under quired by or under authority of the Act any requirements in this part and sec- to appear on the label or labeling shall tion 11(b) of the Poultry Products In- appear thereon in the English lan- spection Act shall bear the designation guage: Provided, however, That in the ‘‘Sample Seal’’ accompanied by the of- case of products distributed solely in ficial USDA logo as shown below. Any Puerto Rico, Spanish may be sub- seal approved by the Administrator for stituted for English for all printed applying such mark shall be deemed an matter except the USDA inspection official device for purposes of the Act. legend.

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(b) The principal display panel shall (i) If the first surface to the right of be the part of a label that is most like- the principal display panel is too small ly to be displayed, presented, shown, or to accommodate the required informa- examined under customary conditions tion or is otherwise unusable label of display for sale. The principal dis- space, e.g., folded flaps, tear strips, play panel shall be large enough to ac- opening flaps, heat-sealed flaps, the commodate all the mandatory label in- next panel to the right of this part of formation required to be placed there- the label may be used. on by the regulations with clarity and (ii) If the package has one or more al- conspicuousness and without being ob- ternate principal display panels, the in- scured by design or vignettes, or formation panel is to the right of any crowding. Where packages bear alter- principal display panel. nate principal display panels, informa- (iii) If the top of the container is the tion required to be placed on the prin- principal display panel and the pack- cipal display panel shall be duplicated age has no alternate principal display on each principal display panel. The panel, the information panel is any area that is to bear the principal dis- panel adjacent to the principal display play panel shall be: panel. (1) In the case of a rectangular pack- (2) (i) Except as otherwise permitted age, one entire side, the area of which in this part, all information required to is the product of the height times the appear on the principal display panel width of that side. or permitted to appear on the information panel shall appear on the same (2) In the case of a cylindrical or panel unless there is insufficient space. nearly cylindrical container: In determining the sufficiency of the (i) An area on the side of the con- available space, except as otherwise tainer that is 40 percent of the product prescribed in this part, any vignettes, of the height of the container times the designs, and any other nonmandatory circumference, or information shall not be considered. If (ii) A panel, the width of which is there is insufficient space for all re- one-third of the circumference and the quired information to appear on a sin- height of which is as high as the con- gle panel, it may be divided between tainer: Provided, however, That there is, the principal display panel and the in- immediately to the right or left of such formation panel, provided that the in- principal display panel, a panel which formation required by any given provi- has a width not greater than 20 percent sion of this part, such as the ingredi- of the circumference and a height as ents statement, is not divided and ap- high as the container, and which is re- pears on the same panel. served for information prescribed in (ii) All information appearing on the §§ 381.118, 381.122, and 381.123. Such information panel pursuant to this sec- panel shall be known as the ‘‘20 percent tion shall appear in one place without panel’’ and such information may be intervening material, such as designs shown on that panel in lieu of showing or vignettes. it on the principal display panel as provided in this § 381.116. [37 FR 9706, May 16, 1972, as amended at 40 (3) In the case of a container of any FR 11347, Mar. 11, 1975; 59 FR 40214, Aug. 8, 1994] other shape, 40 percent of the total surface of the container. § 381.117 Name of product and other In determining the area of the prin- labeling. cipal display panel, exclude tops, bot- (a) The label shall show the name of toms, flanges at tops and bottoms of the product, which, in the case of a cans, and shoulders and necks of bot- poultry product which purports to be tles or jars. or is represented as a product for which (c) (1) The information panel is that a definition and standard of identity or part of a label that is the first surface composition is prescribed in subpart P, to the right of the principal display shall be the name of the food specified panel as observed by an individual fac- in the standard, and in the case of any ing the principal display panel, with other poultry product shall be the com- the following exceptions: mon or usual name of the food, if any

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there be, and if there is none, a truth- statement will not be required, unless ful descriptive designation. the product bears a label referring to (b) The name of the product required the light or dark meat content. In the to be shown on labels for fresh or fro- latter case, the qualifying statement is zen raw whole carcasses of poultry required if the light and dark meat are shall be in either of the following not present in natural proportions. The forms: The name of the kind (such as qualifying statement must be in type chicken, turkey, or duck) preceded by at least one-half the size and of equal the qualifying term ‘‘young’’ or ‘‘ma- boldness as the name of the product; ture’’ or ‘‘old’’, whichever is appro- e.g., Boned Turkey (Dark Meat). priate; or the appropriate class name as described in § 381.170(a). The name of TABLE 1 the kind may be used in addition to the Percent light Percent class name, but the name of the kind Label terminology meat dark meat alone without the qualifying age or Natural proportions ...... 50–65 50–35 class term is not acceptable as the Light or white meat ...... 100 0 name of the product, except that the Dark meat ...... 0 100 name ‘‘chicken’’ may be used without Light and dark meat ...... 51–65 49–35 Dark and light meat ...... 35–49 65–51 such qualification with respect to a Mostly white meat ...... 66 or more 34 or less ready-to-cook pack of fresh or frozen Mostly dark meat ...... 34 or less 66 or more cut-up young chickens, or a half of a young chicken, and the name (d) Boneless poultry products shall be ‘‘duckling’’ may be used without such labeled in a manner that accurately de- qualification with respect to a ready- scribes their actual form and composi- to-cook pack of fresh or frozen young tion. The product name shall specify ducks. The class name may be appro- the form of the product (e.g., priately modified by changing the word emulsified, finely chopped, etc.), and form, such as using the term ‘‘roasting the kind name of the poultry, and if chicken’’, rather than ‘‘roaster.’’ The the product does not consist of natural appropriate names for cut-up parts are proportions of skin and fat, as they set forth in § 381.170(b). When naming occur in the whole carcass, shall also parts cut from young poultry, the iden- include terminology that describes the tity of both the kind of poultry and the actual composition. If the product is name of the part shall be included in cooked, it shall be so labeled. For the the product name. The product name purpose of this paragraph, natural pro- for parts or portions cut from mature portions of skin, as found on a whole poultry shall include, along with the chicken or turkey carcass, will be con- part or portion name, the class name sidered to be as follows: or the qualifying term ‘‘mature.’’ The Percent name of the product for cooked or heat processed poultry products shall in- Raw Cooked clude the kind name of the poultry Chicken ...... 20 25 from which the product was prepared Turkey ...... 15 20 but need not include the class name or the qualifying term ‘‘mature.’’ Boneless poultry product shall not (c) Poultry products containing light have a bone solids content of more and dark chicken or turkey meat in than 1 percent, calculated on a weight quantities other than the natural pro- basis. portions, as indicated in Table 1 in this (e) On the label of any ‘‘Mechanically paragraph, must have a qualifying Separated (Kind of Poultry) ‘‘ described statement in conjunction with the in § 381.173, the name of such product name of the product indicating, as shall be followed immediately by the shown in Table 1, the types of meat ac- phrase: ‘‘with excess skin’’ unless such tually used, except that when the prod- product is made from poultry product uct contains less than 10 percent that does not include skin in excess of cooked deboned poultry meat or is the natural proportion of skin present processed in such a manner that the on the whole carcass, as specified in character of the light and dark meat is paragraph (d) of this section. Appro- not distinguishable, the qualifying priate terminology on the label shall

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indicate if heat treatment has been priate. No ingredient to which the used in the preparation of the product. quantifying statement applies may be The labeling information described in present in an amount greater than the this paragraph shall be identified on stated threshold. Such a quantifying the label before the product leaves the statement may also be utilized when establishment at which it is manufac- an ingredients statement contains a tured. listing of ingredients by individual (f) The labels of sausages encased in components. Each component listing natural casings made from meat or may utilize the required quantifying poultry viscera shall identify the type statement at the end of each compo- of meat or poultry from which the cas- nent ingredients listing. ings were derived, if the casings are (ii) Such ingredients may be adjusted from a different type of meat or poul- in the product formulation without a try than the encased meat or poultry. change being made in the ingredients The identity of the casing, if required, statement on the labeling, provided may be placed on the principal display that the adjusted amount complies panel or in the ingredient statement. with subpart P of this part and Establishments producing, manufac- § 424.21(c) of subchapter E, and does not turing, or using natural sausage cas- exceed the amount shown in the quan- ings are to maintain records docu- tifying statement. Any such adjust- menting the meat or poultry source in ments to the formulation shall be pro- accordance with subpart Q of this part. vided to the inspector-in-charge. (g) The labels of sausages encased in regenerated collagen casings shall dis- (b) For the purpose of this paragraph, close this fact on the product label. the term ‘‘chicken meat,’’ unless modi- The fact that the sausage is encased in fied by an appropriate adjective, is con- collagen may be placed on the prin- strued to mean deboned white and dark cipal display panel or in the ingredient meat; whereas the term ‘‘chicken’’ may statement. include other edible parts such as skin and fat not in excess of their natural [37 FR 9706, May 16, 1972, as amended at 60 proportions, in addition to the chicken FR 55983, Nov. 3, 1995; 66 FR 40845, Aug. 6, meat. If the term ‘‘chicken meat’’ is 2001] listed and the product also contains § 381.118 Ingredients statement. skin, giblets, or fat, it is necessary to list each such ingredient. Similar prin- (a)(1) The label shall show a state- ciples shall be followed in listing ingre- ment of the ingredients in the poultry dients of poultry products processed product if the product is fabricated from other kinds of poultry. from two or more ingredients. Such ingredients shall be listed by their com- (c) The terms spice, natural flavor, mon or usual names in the order of natural flavoring, flavor or flavoring their descending proportions, except as may be used in the following manner: prescribed in paragraph (a)(2) of this (1) The term ‘‘spice’’ means any aro- section. matic vegetable substance in the (2)(i) Product ingredients which are whole, broken, or ground form, with present in individual amounts of 2 per- the exceptions of onions, garlic and cent or less by weight may be listed in celery, whose primary function in food the ingredients statement in other is seasoning rather than nutritional than descending order of predomi- and from which no portion of any vola- nance: Provided, That such ingredients tile oil or other flavoring principle has are listed by their common or usual been removed. Spices include the spices names at the end of the ingredients listed in 21 CFR 182.10, and 184. statement and preceded by a quanti- (2) The term ‘‘natural flavor,’’ ‘‘nat- fying statement, such as ‘‘Contains ural flavoring,’’ ‘‘flavor’’ or ‘‘fla- lllll percent or less of lllll ,’’ voring’’ means the essential oil, oleo- or ‘‘Less than lllll percent of resin, essence or extractive, protein hy- lllll .’’ The percentage of the in- drolysate, distillate, or any product of gredient(s) shall be filled in with a roasting, heating or enzymolysis, threshold level of 2 percent, 1.5 percent, which contains the flavoring constitu- 1.0 percent, or 0.5 percent, as appro- ents derived from a spice, fruit or fruit

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juice, vegetable or vegetable juice, edi- (1)(i) The two kinds of poultry used ble yeast, herb, bark, bud, root, leaf or must comprise at least 70 percent by any other edible portions of a plant, weight of the poultry and the poultry meat, seafood, poultry, eggs, dairy ingredients [e.g. giblets, skin or fat in products, or fermentation products excess of natural proportions, or me- thereof, whose primary function in chanically separated (kind)] used; and, food is flavoring rather than nutri- (ii) Neither of the two kinds of poul- tional. Natural flavors include the nat- try used can be less than 30 percent by ural essence or extractives obtained weight of the total poultry and poultry from plants listed in 21 CFR 182.10, ingredients used; 182.20, 182.40, 182.50 and 184, and the (2) The word ‘‘and’’ in lieu of a substances listed in 21 CFR 172.510. The comma must be shown between the term natural flavor, natural flavoring, declaration of the two kinds of poultry flavor or flavoring may also be used to in the ingredients statement and in the designate spices, powdered onion, pow- product name. dered garlic, and powdered celery. [37 FR 9706, May 16, 1972, as amended at 55 (i) Natural flavor, natural flavoring, FR 7294, Mar. 1, 1990; 55 FR 26422, June 28, flavor or flavoring as described in para- 1990; 58 FR 38049, July 15, 1993; 59 FR 40215, graph (c)(1) and (2) of this section, Aug. 8, 1994; 63 FR 11360, Mar. 9, 1998; 76 FR which are also colors shall be des- 82078, Dec. 30, 2011] ignated as ‘‘natural flavor and coloring,’’ ‘‘natural flavoring and coloring,’’ § 381.119 Declaration of artificial fla- ‘‘flavor and coloring’’ or ‘‘flavoring and voring or coloring. coloring’’ unless designated by their (a) When an artificial smoke fla- common or usual name. voring or a smoke flavoring is added as (ii) Any ingredient not designated in an ingredient in the formula of any paragraphs (c) (1) and (2) of this section poultry product, there shall appear on whose function is flavoring, either in the label, in prominent letters and con- whole or in part, must be designated by tiguous to the name of the product, a its common or usual name. Those in- statement such as ‘‘Artificial Smoke gredients which are of livestock or Flavoring Added’’ or ‘‘Smoke Fla- poultry origin must be designated by voring Added,’’ as applicable, and the names that include the species and ingredient statement shall identify any livestock and poultry tissues from artificial smoke flavoring or smoke fla- which the ingredients are derived. voring added as an ingredient in the (d) On containers of frozen dinners, formula of the poultry product. entrees, and pizzas, and similarly pack- (b) Any poultry product which bears aged products in cartons, the ingre- or contains any artificial flavoring dient statement may be placed on the other than an artificial smoke fla- front riser panel: Provided, That the voring or a smoke flavoring, or bears words ‘‘see ingredients,’’ followed im- or contains any artificial coloring shall mediately by an arrow pointing to the bear a statement stating that fact on front riser panel, are placed on the the immediate container or, if there is principal display panel immediately none, on the product. above the location of such statement, without intervening printing or de- § 381.120 Antioxidants; chemical pre- signs. servatives; and other additives. (e) The ingredients statement may be When an antioxidant is added to a placed on the information panel, ex- poultry product, there shall appear on cept as otherwise permitted in this the label in prominent letters and con- subchapter. tiguous to the name of the product, a (f) Establishments may interchange statement showing the name of the the identity of two kinds of poultry antioxidant and the purpose for which (e.g., chicken and turkey, chicken it is added, such as ‘‘BHA added to help meat and turkey meat) used in a prod- protect the flavor.’’ Immediate con- uct formulation without changing the tainers of poultry products packed in, product’s ingredient statement or prod- bearing, or containing any chemical uct name under the following condi- preservative shall bear a label stating tions: that fact and naming the additive and

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the purpose of its use. Immediate con- container bears a statement ‘‘Tare tainers of poultry products packed in, weight of consumer package’’ and in bearing or containing any other chem- close proximity thereto, the actual ical additive shall bear a label naming tare weight (weight of packaging mate- the additive and the purpose of its use rial), weighed to the nearest one-eighth when required by the Administrator in ounce or less, of the individual con- specific cases. When approved sumer package in the shipping con- proteolytic enzymes as permitted in a tainer. The above-specified statements regulation permitting that use in this may be added to approved shipping subchapter or 9 CFR Chapter III, Sub- container labels upon approval by the chapter E, or in 21 CFR Chapter I, Sub- inspector in charge. chapter A or Subchapter B of this sub- (b) When a poultry product and a chapter are used in mature poultry muscle tissue, there shall appear on nonpoultry product are separately the label, in a prominent manner, con- wrapped and are placed in a single im- tiguous to the product name, the state- mediate container bearing the same ment ‘‘Tenderized with [approved en- name of both products, the net weight zyme],’’ to indicate the use of such en- on such immediate container may be zymes. Any other approved substance the total net weight of the products, or which may be used in the solution shall such immediate container may show also be included in the statement. the net weights of the poultry product When approved inorganic chlorides as and the nonpoultry product separately. permitted in a regulation permitting Notwithstanding the other provisions that use in this subchapter or 9 CFR of this paragraph, the label on con- Chapter III, Subchapter E, or in 21 CFR sumer size retail packages of stuffed Chapter I, Subchapter A or Subchapter poultry and other stuffed poultry prod- B of this subchapter are used in mature ucts must show the total net weight of poultry muscle tissue, there shall ap- the poultry product, and in close prox- pear on the label, in a prominent man- imity thereto, a statement specifying ner, contiguous to the product name, the minimum weight of the poultry in the statement, ‘‘Tenderized with (name the product. of approved inorganic chloride(s))’’ to (c)(1) The statement of net quantity indicate the use of such inorganic of contents shall appear (except as oth- chlorides. Any other approved sub- erwise permitted under this paragraph stance which may be used in the solu- (c)), on the principal display panel of tion shall also be included in the state- all containers to be sold at retail in- ment. tact, in conspicuous and easily legible [37 FR 9706, May 16, 1972, as amended at 45 boldface print or type, in distinct con- FR 58820, Sept. 5, 1980; 49 FR 18999, May 4, trast to other matter on the container, 1984; 64 FR 72175, Dec. 23, 1999] and shall be declared in accordance § 381.121 Quantity of contents. with the provisions of this paragraph (c). An unused tare weight, as defined (a) The label shall bear a statement in section 381.121b of this subchapter, of the quantity of contents in terms of may be printed adjacent to the state- weight or measures as provided in ment of net quantity of contents when paragraph (c)(5) of this section. How- ever, the Administrator may approve the product is packaged totally with the use of labels for certain types of impervious packaging material and is consumer packages which do not bear a packed with a usable medium. statement of the net weight that would (2) The statement shall be placed on otherwise be required under this sub- the principal display panel within the paragraph: Provided, That the shipping bottom 30 percent of the area of the container bears a statement ‘‘Net panel, in lines generally parallel to the weight to be marked on consumer base: Provided, That on packages hav- packages prior to display and sale’’: ing a principal display panel of 5 square And provided further, That the total net inches or less, the requirement for weight of the contents of the shipping placement within the bottom 30 per- container is marked on such container: cent of the area of the label panel shall And provided further, That the shipping not apply when the statement meets

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the other requirements of this para- height of the lettering used in the graph. The declaration may appear in statement. more than one line. (5) The terms ‘‘net weight’’ or ‘‘net (3) The statement shall be in letters wt.’’ shall be used when stating the net and numerals in type size established quantity of contents in terms of in relationship to the area of the prin- weight, and the term ‘‘net contents’’ or cipal display panel of the package and ‘‘contents’’ when stating the net quan- shall be uniform for all packages of tity of contents in terms of fluid meas- substantially the same size by com- ure. Except as provided in § 381.128, the plying with the following type speci- statement shall be expressed in terms fications: of avoirdupois weight or liquid meas- (i) Not less than one-sixteenth inch ure. Where no general consumer usage in height on containers, the principal to the contrary exists, the statement display panel of which has an area of 5 shall be in terms of liquid measure, if square inches or less; the product is liquid, or in terms of (ii) Not less than one-eighth inch in weight if the product is solid, semi- height on containers, the principal dis- solid, viscous or a mixture of solid and play panel of which has an area of more liquid. On packages containing less than 5 but not more than 25 square than 1 pound or 1 pint, the statement inches; shall be expressed in ounces or frac- (iii) Not less than three-sixteenth tions of a pint, respectively. On pack- inch in height on containers, the prin- ages containing 1 pound or 1 pint or cipal display panel of which has an more, and less than 4 pounds or 1 gal- area of more than 25 but not more than lon, the statement shall be expressed 100 square inches; as a dual declaration both in ounces (iv) Not less than one-quarter inch in and (immediately thereafter in paren- height on containers, the principal dis- thesis) in pounds, with any remainder play panel of which has an area of more in terms of ounces or common or dec- than 100 but not more than 400 square imal fraction of the pound, or in the inches; case of liquid measure, in the largest (v) Not less than one-half inch in whole units with any remainder in height on containers, the principal dis- terms of fluid ounces or common or play panel of which has an area of more decimal fraction of the pint or quart. than 400 square inches. For example, a declaration of three- (vi) The ratio of height to width of fourths pound avoirdupois weight shall letters and numerals shall not exceed a be expressed as ‘‘Net Wt. 12 oz.’’; a dec- differential of 3 units to 1 unit (no laration of 11⁄2 pounds avoirdupois more than 3 times as high as it is weight shall be expressed as ‘‘Net Wt. wide). This height standard pertains to 24 oz. (1 lb. 8 oz.),’’ ‘‘Net Wt. 24 oz. (11⁄2 upper case or capital letters. When lb.),’’ or ‘‘Net Wt. 24 oz. (1.5 lbs.).’’ How- upper and lower case or all lower case ever, on random weight packages the letters are used, it is the lower case statement shall be expressed in terms letter ‘‘o’’ or its equivalent that shall of pounds and decimal fractions of the meet the minimum standards. When pound, for packages over 1 pound, and fractions are used, each component nu- for packages which do not exceed 1 meral shall meet one-half the height pound the statement may be in decimal standards. fractions of the pound in lieu of ounces. (4) The statement shall appear as a The numbers may be written in pro- distinct item on the principal display vided the unit designation is printed. panel and shall be separated, from Paragraphs (c) (8) and (9) of this sec- other label information appearing to tion permit certain exceptions to this the left or right of the statement, by a paragraph for multi-unit packages, and space at least equal in width to twice random weight consumer size and the width of the letter ‘‘N’’ of the style small packages (less than 1⁄2 ounce), re- of type used in the quantity of con- spectively. tents statement and shall be separated (6) The statement as it is shown on a from other label information appearing label shall not be false or misleading above or below the statement by a and shall express an accurate state- space at least equal in height to the ment of the quantity of contents of the

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container. Reasonable variations through moisture loss during good dis- caused by loss or gain of moisture dur- tribution practices and are designated ing the course of good distribution as gray area type of products as defined practices or by unavoidable deviations in NBS handbook 133, section 3.18.2, in good manufacturing practices will need not bear a net weight statement be recognized. Variations from stated when shipped from an official estab- quantity of contents shall be as pro- lishment provided a net weight ship- vided in section 381.121b of this sub- ping statement which meets the re- chapter. The statement shall not in- quirements of paragraph (c)(6) of this clude any term qualifying a unit of section is applied to the shipping con- weight, measure, or count such as tainer prior to shipping it from the of- ‘‘jumbo quart,’’ ‘‘full gallon,’’ ‘‘giant ficial establishment. Net weight state- quart,’’ ‘‘when packed,’’ ‘‘minimum,’’ ments so applied to the shipping con- or words of similar importance except tainer are exempt from the type size, as provided in paragraph (b) of this sec- dual declaration, and placement re- tion. quirements of this paragraph if an ac- (7) Labels for containers which bear curate statement of net weight is any representation as to the number of shown conspicuously on the principal servings contained therein shall bear, display panel of the shipping container. contiguous to such representation, and The net weight also shall be applied di- in the same size type as is used for rectly to random weight consumer size such representation, a statement of the packages prior to retail display and net quantity of each such serving. sale. The net weight statement of ran- (8) On a multiunit retail package, a dom weight consumer size packages for statement of the quantity of contents retail sale shall be exempt from the shall appear on the outside of the pack- type size, dual declaration, and place- age and shall include the number of in- ment requirements of this paragraph if dividual units, the quantity of each in- an accurate statement of net weight is dividual unit, and, in parentheses, the shown conspicuously on the principal total quantity of contents of the multi- display panel of the package. unit package in terms of avoirdupois or (ii) Individually wrapped and labeled fluid ounces, except that such declara- packages of less than 1⁄2 ounce net tion of total quantity need not be fol- weight and random weight consumer lowed by an additional parenthetical size packages shall be exempt from the declaration in terms of the largest requirements of this paragraph if they whole units and subdivisions thereof, are in a shipping container and the as otherwise required by this para- statement of net quantity of contents graph (c). ‘‘A multiunit retail package’’ on the shipping container meets the re- is a package containing two or more quirements of paragraph (c)(6) of this individually packaged units of the section; identical commodity and in the same (iii) Individually wrapped and labeled quantity, with the individual packages packages of less than 1⁄2 ounce net intended to be sold as part of the mul- weight bearing labels declaring net tiunit retail package but capable of weight, price per pound, and total being sold individually. Open multiunit price, shall be exempt from the type retail packages that do not obscure the size, dual declaration, and placement number of units and the labeling there- requirements of this paragraph if an on are not subject to this paragraph (c) accurate statement of net weight is (8) if the labeling of each individual shown conspicuously on the principal unit complies with the requirements of display panel of the package. this paragraph (c). (10) As used in this section a ‘‘ran- (9) The following exemptions from dom weight consumer size package’’ is the requirements contained in this sec- one of a lot, shipment or delivery of tion are hereby established: packages of the same product, with (i) Individually wrapped, random varying weights and with no fixed weight consumer size packages of poul- weight pattern. try products (as specified in paragraph [37 FR 9706, May 16, 1972, as amended at 39 (c)(10) of this section) and poultry prod- FR 4569, Feb. 5, 1974; 53 FR 28635, July 29, ucts that are subject to shrinkage 1988; 55 FR 49835, Nov. 30, 1990]

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§§ 381.121a–381.121e [Reserved] and legible and accompanied by the prefix ‘‘P’’. § 381.122 Identification of manufacturer, packer or distributor. [47 FR 29515, July 7, 1982] The name and address, including zip § 381.124 Dietary food claims. code, of the manufacturer, packer, or If a product purports to be or is rep- distributor shall be shown on the label resented for any special dietary use by and if only the name and address of the man, its label shall bear a statement distributor is shown, it shall be quali- concerning its vitamin, mineral, and fied by such term as ‘‘packed for,’’ other dietary properties upon which ‘‘distributed by,’’ or ‘‘distributors.’’ the claim for such use is based in whole The name and place of business of the or in part and shall be in conformity manufacturer, packer, or distributor with regulations (21 CFR part 125) es- may be shown on the principal display tablished pursuant to sections 403 and panel, on the 20-percent panel of the 701 of the Federal Food, Drug, and Cos- principal display panel reserved for re- metic Act (21 U.S.C. 343, 371). quired information, on the front riser panel of frozen food cartons, or on the § 381.125 Special handling label re- information panel. quirements. (a) Packaged products which require [37 FR 9706, May 16, 1972, as amended at 59 FR 40215, Aug. 8, 1994] special handling to maintain their wholesome condition shall have promi- § 381.123 Official inspection mark; offi- nently displayed on the principal dis- cial establishment number. play panel of the label the statement: ‘‘Keep Refrigerated,’’ ‘‘Keep Frozen,’’ The immediate container of every in- ‘‘Keep Refrigerated or Frozen,’’ ‘‘Per- spected and passed poultry product ishable—Keep Under Refrigeration,’’ or shall bear: such similar statement as the Adminis- (a) The official inspection legend; and trator may approve in specific cases. (b) The official establishment num- The immediate containers for products ber of the official establishment in that are frozen during distribution and which the product was processed under intended to be thawed prior to or dur- inspection and placed as follows: ing display for sale shall bear the (1) Within the official inspection leg- statement ‘‘Shipped/Stored and Han- end in the form required by subpart M dled Frozen for Your Protection, Keep of this part; or Refrigerated or Freeze.’’ For all canned (2) Outside the official inspection leg- perishable products, the statement end elsewhere on the exterior of the shall be shown in upper case letters container or its labeling, e.g., the lid of one-fourth inch in height for con- a can, if shown in a prominent and leg- tainers having a net weight of 3 pounds ible manner in a size sufficient to in- or less, and for containers having a net sure easy visibility and recognition and weight over 3 pounds, the statement accompanied by the prefix ‘‘P’’; or shall be shown in letters one-half inch (3) Off the exterior of the container, in height. e.g., on a metal clip used to close cas- (b) Safe handling instructions shall ings or bags, or on the back of a paper be provided for all poultry products not label of a canned product, or on other processed in accordance with the provi- packaging or labeling in the container, sions of § 381.150(a) or that have not un- e.g., on aluminum pans and trays dergone other processing that would placed within containers, when a state- render them ready-to-eat, except as ex- ment of its location is printed contig- empted under paragraph (b)(4) of this uous to the official inspection legend, section. such as ‘‘Plant No. on Package Clo- (1) (i) Safe handling instructions sure’’ or ‘‘Plant No. on Pan’’, if shown shall accompany the poultry products, in a prominent and legible manner in a specified in this paragraph (b), destined size sufficient to ensure easy visibility for household consumers, hotels, res- and recognition; or taurants, or similar institutions and (4) On an insert label placed under a shall appear on the label. The informa- transparent covering if clearly visible tion shall be in lettering no smaller

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than one-sixteenth of an inch in size (A graphic illustration of a refrigerator and shall be prominently placed with shall be displayed next to the state- such conspicuousness (as compared ment.); with other words, statements, designs (ii) Keep raw meat and poultry sepa- or devices in the labeling) as to render rate from other foods. Wash working it likely to be read and understood by surfaces (including cutting boards), the ordinary individual under cus- utensils, and hands after touching raw tomary conditions of purchase and use. meat or poultry. (A graphic illustra- (ii) The safe handling information tion of soapy hands under a faucet shall be presented on the label under shall be displayed next to the state- the heading ‘‘Safe Handling Instruc- ment.); tions’’ which shall be set in type size larger than the print size of the ration- (iii) Cook thoroughly. (A graphic il- ale statement and handling statements lustration of a skillet shall be dis- as discussed in paragraphs (b)(2) and played next to the statement.); and (b)(3) of this section. The safe handling (iv) Keep hot foods hot. Refrigerate information shall be set off by a border leftovers immediately or discard. (A and shall be one color type printed on graphic illustration of a thermometer a single color contrasting background shall be displayed next to the state- whenever practical. ment.) (2) (i) The labels of the poultry prod- (4) Poultry products intended for fur- ucts, specified in this paragraph (b) and ther processing at another official es- prepared from inspected and passed tablishment are exempt from the re- poultry, shall include the following ra- quirements prescribed in paragraphs tionale statement as part of the safe (b)(1) through (b)(3) of this section. handling instructions, ‘‘This product was prepared from inspected and passed [37 FR 9706, May 16, 1972, as amended at 39 meat and/or poultry. Some food prod- FR 4569, Feb. 5, 1974; 59 FR 14540, Mar. 28, ucts may contain bacteria that could 1994; 64 FR 746, Jan. 6, 1999] cause illness if the product is mis- § 381.126 Date of packing and date of handled or cooked improperly. For processing; contents of cans. your protection, follow these safe handling instructions.’’ This statement (a) Either the immediate container shall be placed immediately after the or the shipping container of all poultry heading and before the safe handling food products shall be plainly and per- statements. manently marked by code or otherwise (ii) The labels of the poultry prod- with the date of packing. If calendar ucts, specified in this paragraph (b) and dating is used, it must be accompanied prepared pursuant to § 381.10(a) (2), (5), by an explanatory statement, as pro- (6), and (7), shall include the following vided in § 381.129(c)(2). rationale statement as part of the safe (b) The immediate container for handling instructions, ‘‘Some food dressed poultry shall be marked with a products may contain bacteria that lot number which shall be the number could cause illness if the product is of the day of the year on which the mishandled or cooked improperly. For poultry was slaughtered or a coded your protection, follow these safe han- number. dling instructions.’’ This statement (c) All canned products shall be shall be placed immediately after the heading and before the safe handling plainly and permanently marked, by statements. code or otherwise, on the containers, (3) Poultry products, specified in this with the identity of the contents and paragraph (b), shall bear the labeling date of canning, except that canned statements. products packed in glass containers are (i) Keep refrigerated or frozen. Thaw not required to be marked with the in refrigerator or microwave. (Any por- date of canning if such information ap- tion of this statement that is in con- pears on the shipping container. If cal- flict with the product’s specific han- endar dating is used, it must be accom- dling instructions may be omitted, e.g., panied by an explanatory statement, as instructions to cook without thawing.) provided in § 381.129(c)(2).

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(d) If any marking is by code, the in- leading. However, established trade spector in charge shall be informed as names and other labeling and con- to its meaning. tainers which are not false or mis- [37 FR 9706, May 16, 1972, as amended at 39 leading and which are approved by the FR 28516, Aug. 8, 1974; 39 FR 35784, Oct. 4, Administrator in the regulations or in 1974] specific cases are permitted. (b) No statement, word, picture, de- § 381.127 Wording on labels of ship- sign, or device which is false or mis- ping containers. leading in any particular or conveys (a) Each label for use on a shipping any false impression or gives any false container for inspected and passed indication of origin, identity, or qual- poultry products shall bear, in dis- ity, shall appear on any label. For ex- tinctly legible form, the following in- ample: formation: (1) Official grade designations such as (1) The official inspection legend. the letter grades A, B, and C may be (2) The official establishment number used in labeling individual carcasses of of the official establishment in which poultry or containers of poultry prod- the poultry product was inspected, ei- ucts only if such articles have been ther within the official inspection graded by a licensed grader of the Fed- mark, or elsewhere on the container eral or Federal-State poultry grading clearly visible and in proximity to the service and found to qualify for the in- official inspection mark. dicated grade. (2) Terms having geographical sig- § 381.128 Labels in foreign languages. nificance with reference to a particular Any label to be affixed to a container locality may be used only when the of any dressed poultry or other poultry product was produced in that locality. product for foreign commerce may be (3) ‘‘Fresh frozen’’, ‘‘quick frozen’’, printed in a foreign language. However, ‘‘frozen fresh’’, and terms of similar the official inspection legend and es- import apply only to ready-to-cook tablishment number shall appear on poultry processed in accordance with the label in English, but in addition, § 381.66(f)(1). Ready-to-cook poultry may be literally translated into such handled in any other manner and foreign language. Each such label shall dressed poultry may be labeled ‘‘fro- be subject to the applicable provisions zen’’ only if it is frozen in accordance of §§ 381.115 to 381.141, inclusive. Devi- with § 381.66(f)(2) under Department su- ations from the form of labeling re- pervision and is in fact in a frozen quired under the regulations may be state. ‘‘Individually quick frozen approved by the Administrator in spe- (Kind)’’ and terms of similar import cific cases and such modified labeling are applicable only to poultry products may be used for poultry products to be that are frozen as stated on the label exported: Provided, (a) That the pro- and whose component parts can be eas- posed labeling accords to the specifica- ily separated at time of packing. tions of the foreign purchaser, (b) that (4) Poultry products labeled with a it is not in conflict with the Act or the term quoted in any paragraph of laws of the country to which it is in- § 381.170(b) shall comply with the speci- tended for export, and (c) that the out- fications in the applicable paragraph. side of the shipping container is la- However, parts of poultry may be cut beled to show that it is intended for ex- in any manner the processor desires as port; but if such product is sold or of- long as the labeling appropriately re- fered for sale in domestic commerce, flects the contents of the container of all the requirements of the regulations such poultry. shall apply. (5) The terms ‘‘All,’’ ‘‘Pure,’’ ‘‘100%,’’ and terms of similar connotation shall § 381.129 False or misleading labeling not be used on labels for products to or containers. identify ingredient content, unless the (a) No poultry product subject to the product is prepared solely from a single Act shall have any false or misleading ingredient. labeling or any container that is so (6)(i) Raw poultry product whose in- made, formed, or filled as to be mis- ternal temperature has ever been below

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26°F may not bear a label declaration does not cause the raw poultry product of ‘‘fresh.’’ Raw poultry product bear- to become misbranded. If used, an op- ing a label declaration of ‘‘fresh’’ but tional, descriptive term must be promi- whose internal temperature has ever nently displayed on the principal dis- been below 26°F is mislabeled. The play panel of the label. If additional la- ‘‘fresh’’ designation may be deleted beling containing the optional, descrip- from such product in accordance with tive term is affixed to the label, it § 381.133(b)(9)(xxiv). The temperature of must be prominently affixed on the individual packages of raw poultry label. The additional labeling must be product within an official establish- so conspicuous (as compared with other ment may deviate below the 26°F words, statements, designs, or devices standard by 1° (i.e., have a temperature in the labeling) that it is likely to be of 25°F) and still be labeled ‘‘fresh.’’ read and understood by the ordinary The temperature of individual pack- individual under customary conditions ages of raw poultry product outside an of purchase and use. official establishment may deviate (iv) Handling and relabeling of prod- ° ° below the 26 F standard by 2 (i.e., have ucts. (A) Except as provided under para- ° a temperature of 24 F) and still be la- graph (b)(6)(iii)(C) of this section, when beled ‘‘fresh.’’ The average tempera- any inspected and passed product has ture of poultry product lots of each ° become misbranded under this subpart specific product type must be 26 F. after it has been transported from an Product described in this paragraph is official establishment, such product not subject to the freezing procedures may be transported in commerce to an required in § 381.66(f)(2) of this sub- official establishment after oral per- chapter. mission is obtained from the Area Su- (ii) Raw poultry product whose inter- pervisor of the area in which that offi- nal temperature has ever been at or cial establishment is located. The below 0°F must be labeled with the de- transportation of the product may be scriptive term ‘‘frozen,’’ except when to the official establishment from such labeling duplicates or conflicts which it had been transported or to an- with the labeling requirements in other official establishment designated § 381.125 of this subchapter. The word ‘‘previously’’ may be placed next to the by the person desiring to handle the term ‘‘frozen’’ on an optional basis. product. The transportation shall be The descriptive term must be promi- authorized only for the purpose of the nently displayed on the principal dis- relabeling of the product. The Area Su- play panel of the label. If additional la- pervisor shall record the authorization beling containing the descriptive term and other information necessary to is affixed to the label, it must be identify the product and shall provide a prominently affixed to the label. The copy of the record to the inspector at additional labeling must be so con- the establishment receiving the prod- spicuous (as compared with other uct. The shipper shall be furnished a words, statements, designs, or devices copy of the authorization record upon in the labeling) that it is likely to be request. read and understood by the ordinary (B) Upon the arrival of the shipment individual under customary conditions at the official establishment, a careful of purchase and use. Product described inspection shall be made of the product in this paragraph is subject to the by the inspector, and if it is found that freezing procedures required in the product is not adulterated, it may § 381.66(f)(2) of this subchapter. be received into the establishment; but (iii) Raw poultry product whose in- if the product is found to be adulter- ternal temperature has ever been below ated, it shall at once be condemned and 26°F, but is above 0°F, is not required disposed of in accordance with § 381.95 to bear any specific descriptive term. of this subchapter. Wholesome product Raw poultry product whose internal will be relabeled in accordance with temperature has ever been below 26°F, paragraph (b)(6) (i) or (ii) of this sec- but is above 0°F, may bear labeling tion, as appropriate. with an optional, descriptive term, pro- (C) When any inspected and passed vided the optional, descriptive term product has become misbranded under

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this subpart after it has been trans- matrix in ground or formed poultry ported from an official establishment, products, as permitted in § 424.21(c) of the owner may transport the product subchapter E, there shall appear on the in commerce to a retail entity for relabel contiguous to the product name a labeling in accordance with paragraph statement to indicate the use of so- (b)(6) (i) or (ii) of this section, as appro- dium alginate, calcium carbonate, lac- priate, or to other end users, such as tic acid, and calcium lactate. hotels, restaurants or similar institu- (e) When transglutaminase enzyme is tions; or, relabel the product in accord- used to bind pieces of poultry to form ance with paragraph (b)(6) (i) or (ii) of a cut of poultry, or to reform a piece of this section, as appropriate if the prod- poultry from a multiple cuts of poul- uct is already at a retail entity. A try, there shall appear on the label, as hotel, restaurant or similar institution part of the product name, a statement is not required to relabel product mis- that indicates that the product has branded under this subpart; Provided, been ‘‘formed’’ or ‘‘reformed,’’ in addi- That the product is prepared in meals tion to other preparation steps, e.g., or as entrees only for sale or service di- ‘‘Formed Turkey Thigh Roast’’ or rectly to individual consumers at such ‘‘Reformed and Shaped Chicken institutions, and that the mark of in- Breast.’’ spection is removed or obliterated. (f) A country of origin statement on Oral permission shall be obtained from the label of any poultry product ‘‘cov- the Area Officer-in-Charge of the Com- ered commodity’’ as defined in 7 CFR pliance Program for the area in which part 65, subpart A, that is to be sold by the product is located prior to such a ‘‘retailer,’’ as defined in 7 CFR 65.240, transportation or relabeling. The Area must comply with the requirements in Officer-in-Charge shall record the au- 7 CFR 65.300 and 65.400. thorization and other information nec- [37 FR 9706, May 16, 1972, as amended at 39 essary to identify the product, and FR 28516, Aug. 8, 1974; 39 FR 42339, Dec. 5, shall furnish a copy of the authoriza- 1974; 55 FR 5977, Feb. 21, 1990; 60 FR 44412, tion record upon request. Before being Aug. 25, 1995; 61 FR 66200, Dec. 17, 1996; 61 FR offered for sale at a retail entity, such 68821, Dec. 30, 1996; 66 FR 54916, Oct. 31, 2001; 73 FR 50703, Aug. 28, 2008; 76 FR 82078, Dec. 30, product shall be relabeled. 2011] (c) A calendar date may be shown on labeling when declared in accordance § 381.130 False or misleading labeling with the provisions of this paragraph: or containers; orders to withhold (1) The calendar date shall express from use. the month of the year and the day of If the Administrator has reason to the month for all products and also the believe that any marking or other la- year in the case of products hermeti- beling or the size or form of any con- cally sealed in metal or glass container in use or proposed for use with tainers, dried or frozen products, or respect to any article subject to the any other products that the Adminis- Act is false or misleading in any par- trator finds should be labeled with the ticular, he may direct that the use of year because the distribution and mar- the article be withheld unless it is keting practices with respect to such modified in such manner as the Admin- products may cause a label without a istrator may prescribe so that it will year identification to be misleading. not be false or misleading. If the person (2) Immediately adjacent to the cal- using or proposing to use the labeling endar date shall be a phrase explaining or container does not accept the deter- the meaning of such date in terms of mination of the Administrator, he may ‘‘packing’’ date, ‘‘sell by’’ date, or ‘‘use request a hearing, but the use of the la- before’’ date, with or without a further beling or container shall, if the Admin- qualifying phrase, e.g., ‘‘For Maximum istrator so directs, be withheld pending Freshness’’ or ‘‘For Best Quality’’, and hearing and final determination by the such phrases shall be approved by the Secretary in accordance with applica- Administrator as prescribed in § 381.132. ble rules of practice. Any such deter- (d) When sodium alginate, calcium mination with respect to the matter by carbonate, lactic acid, and calcium lac- the Secretary shall be conclusive un- tate are used together in a dry binding less, within 30 days after the receipt of

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notice of such final determination, the (2) After signing the certificate, the person adversely affected thereby ap- Program employee and the establish- peals to the U.S. Court of Appeals for ment shall each keep a copy, and the the Circuit in which he has his prin- remaining two copies shall be given to cipal place of business, or to the U.S. the marking device manufacturer. Court of Appeals for the District of Co- (3) The manufacturer of the marking lumbia Circuit. The provisions of sec- devices shall engrave or otherwise tion 204 of the Packers and Stockyards mark each marking device with a per- Act of 1921, as amended, shall be appli- manent identifying serial number cable to appeals taken under this sec- unique to it. The manufacturer shall tion. list on each of the two copies of the certificate given to the manufacturer § 381.131 Preparation of labeling or the number of each marking device au- other devices bearing official in- thorized by the certificate. The manu- spection marks without advance ap- facturer shall retain one copy of the proval prohibited; exceptions. certificate for the manufacturer’s (a) Except for the purposes of pre- records and return the remaining copy with the marking devices to the Pro- paring and submitting a sample or gram employee whose name and ad- samples of the same to the Adminis- dress are given on the certificate as the trator for approval, no brand manufac- recipient. turer, printer, or other person shall (4) In order that all such marking de- cast, print, lithograph, or otherwise vices bear identifying numbers, within make any marking device containing one year after June 24, 1985, an estab- any official mark or simulation there- lishment shall either replace each such of, or any label bearing any such mark marking device that does not bear an or simulation, without the written au- identifying number, or, under the di- thority therefor of the Administrator. rection of the inspector-in-charge, However, when any such sample label, mark such marking device with a per- or other marking device, is approved manent identifying number. by the Administrator, additional supplies of the approved label, or marking (Recordkeeping requirements approved by the Office of Management and Budget under device, may be made for use in accord- control number 0583–0015) ance with the regulations in this subchapter, without further approval by [50 FR 21423, May 24, 1985] the Administrator. The provisions of § 381.132 Labeling approval. this paragraph do not apply to marking devices containing the official inspec- (a) No final labeling shall be used on tion legend shown in Figure 5 of any product unless the sketch labeling of such final labeling has been sub- § 381.102. mitted for approval to the Food Label- (b) No brand manufacturer or other ing Division, Regulatory Programs, person shall cast or otherwise make, Food Safety and Inspection Service, without an official certificate issued in and approved by such division, accom- quadruplicate by a Program employee, panied by FSIS Form, Application for a marking device containing the offi- Approval of Labels, Marking, and De- cial inspection legend shown in Figure vices, except for generically approved 5 of § 381.102 or any simulation of that labeling authorized for use in legend. § 381.133(b) (2)–(9). The management of (1) The certificate is a Food Safety the official establishment or establish- and Inspection Service form for signa- ment certified under a foreign inspec- ture by a Program employee and the tion system, in accordance with sub- official establishment ordering the part T of this part, must maintain a marking device, bearing a certificate copy of all labeling used, along with serial number and a letterhead and the the product formulation and processing seal of the United States Department procedure, in accordance with subpart of Agriculture. The certificate author- Q of this part. Such records shall be izes the making of only the devices of made available to any duly authorized the type and quantity listed on the cer- representative of the Secretary upon tificate. request.

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(b) The Food Labeling Division shall (i) The proposed labeling would not permit submission for approval of only misrepresent the product; sketch labeling, as defined in (ii) The use of the labeling would not § 381.132(d), for all products, except as present any potential health, safety, or provided in § 381.133(b) (2)–(9) and except dietary problems to the consumer; for temporary use of final labeling as (iii) Denial of the request would cre- prescribed in paragraph (f) of this sec- ate undue economic hardship; and tion. (iv) An unfair competitive advantage (c) All labeling required to be sub- would not result from the granting of mitted for approval as set forth in the temporary approval. § 381.132(b) shall be submitted in dupli- (2) Extensions of temporary approv- cate to the Food Labeling Division, als may also be granted by the Food Regulatory Programs, Food Safety and Labeling Division, provided that the applicant demonstrates that new cir- Inspection Service, U.S. Department of cumstances, meeting the above cri- Agriculture, Washington, DC 20250. A teria, have developed since the original parent company for a corporation may temporary approval was granted. submit only one labeling application (in duplicate) for a product produced in [60 FR 67456, Dec. 29, 1995] other establishments that are owned by the corporation. § 381.133 Generically approved labeling. (d) ‘‘Sketch’’ labeling is a printer’s proof or equivalent which clearly (a)(1) An official establishment or an shows all labeling features, size, loca- establishment certified under a foreign tion, and indication of final color, as inspection system, in accordance with specified in subpart N of this part. subpart T of this part, is authorized to FSIS will accept sketches that are use generically approved labeling, as hand drawn, computer generated or defined in paragraph (b) of this section, other reasonable facsimiles that clear- without such labeling being submitted for approval to the Food Safety and In- ly reflect and project the final version spection Service in Washington or the of the labeling. Indication of final color field, provided the labeling is in accord may be met by: submission of a color with this section and shows all manda- sketch, submission of a sketch which tory features in a prominent manner as indicates by descriptive language the required in subpart N of this part, and final colors, or submission with the is not otherwise false or misleading in sketch of previously approved final la- any particular. beling that indicates the final colors. (2) The Food Safety and Inspection (e) Inserts, tags, liners, pasters, and Service shall select samples of generi- like devices containing printed or cally approved labeling from the graphic matter and for use on, or to be records maintained by official estab- placed within, containers and coverings lishments and establishments certified of product shall be submitted for ap- under foreign inspection systems, in proval in the same manner as provided accordance with subpart T of this part, for labeling in § 381.132(a), except that as required in § 381.132, to determine such devices which contain no ref- compliance with labeling require- erence to product and bear no mis- ments. Any finding of false or misleading feature shall be used without leading labeling shall institute the pro- submission for approval as prescribed ceedings prescribed in § 381.233. in § 381.133(b)(9). (b) Generically approved labeling is (f)(1) Consistent with the require- labeling which complies with the fol- ments of this section, temporary ap- lowing: proval for the use of a final label or (1) Labeling for a product which has other final labeling that may otherwise a product standard as specified in sub- be deemed deficient in some particular part 381 of this subchapter or the may be granted by the Food Labeling Standards and Labeling Policy Book Division. Temporary approvals may be and which does not contain any special granted for a period not to exceed 180 claims, such as quality claims, nutri- calendar days under the following con- ent content claims, health claims, neg- ditions: ative claims, geographical origin

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claims (except as provided by para- with its unit of measurement, e.g., graph (b)(9)(xxviii) of this section), or ‘‘lb.’’ for ‘‘pound,’’ or ‘‘oz.’’ for guarantees, or which is not a domestic ‘‘ounce,’’ or of the word ‘‘pound’’ for product labeled in a foreign language; ‘‘lb.’’ or ‘‘ounce’’ for ‘‘oz.’’; (2) Labeling for single-ingredient (iii) A master or stock label has been products (such as chicken legs or tur- approved from which the name and ad- key breasts) which does not contain dress of the distributor are omitted and any special claims, such as quality such name and address are applied be- claims, nutrient content claims, health fore being used (in such case, the words claims, negative claims, geographical ‘‘prepared for’’ or similar statement origin claims (except as provided by must be shown together with the blank paragraph (b)(9)(xxviii) of this section), space reserved for the insertion of the or guarantees, or which is not a domes- name and address when such labels are tic product labeled with a foreign lan- offered for approval); guage; (iv) Wrappers or other covers bearing (3) Labeling for containers of prod- pictorial designs, emblematic designs ucts sold under contract specifications or illustrations, e.g., floral arrange- to Federal Government agencies, when ments, illustrations of animals, fire- such product is not offered for sale to works, etc. are used with approved la- the general public, provided that the beling (the use of such designs will not contract specifications include specific make necessary the application of la- requirements with respect to labeling, beling not otherwise required); and are made available to the inspec- (v) A change in the language or the tor-in-charge; arrangement of directions pertaining (4) Labeling for shipping containers to the opening of containers or the which contain fully labeled immediate serving of the product; containers, provided such labeling (vi) The addition, deletion, or amend- complies with § 381.127; ment of a dated or undated coupon, a (5) Labeling for products not in- cents-off statement, cooking instruc- tended for human food, provided they tions, packer product code informa- comply with §§ 381.152(c) and 381.193, tion, or UPC product code information; and labeling for poultry heads and feet (vii) Any change in the name or ad- for export for processing as human food dress of the packer, manufacturer or if they comply with § 381.190(b); distributor that appears in the signa- (6) Poultry inspection legends, which ture line; comply with subpart M of this part; (viii) Any change in the net weight, (7) Inserts, tags, liners, pasters, and provided that the size of the net weight like devices containing printed or statement complies with § 381.121; graphic matter and for use on, or to be placed within containers, and coverings (ix) The addition, deletion, or amend- of products, provided such devices con- ment of recipe suggestions for the tain no reference to product and bear product; no misleading feature; (x) Any change in punctuation; (8) Labeling for consumer test prod- (xi) Newly assigned or revised estab- ucts not intended for sale; and lishment numbers for a particular es- (9) Labeling which was previously ap- tablishment for which use of the label- proved by the Food Labeling Division ing has been approved by the Food La- as sketch labeling, and the final label- beling Division, Regulatory Programs; ing was prepared without modification (xii) The addition or deletion of open or with the following modifications: dating information; (i) All features of the labeling are (xiii) A change in the type of pack- proportionately enlarged or reduced, aging material on which the label is provided that all minimum size re- printed; quirements specified in applicable reg- (xiv) Brand name changes, provided ulations are met and the labeling is that there are no design changes, the legible; brand name does not use a term that (ii) The substitution of any unit of connotes quality or other product char- measurement with its abbreviation or acteristics, the brand name has no geo- the substitution of any abbreviation graphic significance, and the brand

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name does not affect the name of the § 381.129(f) that complies with the re- product; quirements in that paragraph. (xv) The deletion of the word ‘‘new’’ [60 FR 67457, Dec. 29, 1995, as amended at 61 on new product labeling; FR 66201, Dec. 17, 1996; 73 FR 50703, Aug. 28, (xvi) The addition, deletion, or 2008; 76 FR 82079, Dec. 30, 2011] amendment of special handling statements, provided that the change is con- § 381.134 Requirement of formulas. sistent with § 381.125(a); Copies of each label submitted for ap- (xvii) The addition of safe handling proval, shall when the Administrator instructions as required by § 381.125(b); requires in any specific case, be accom- (xviii) Changes reflecting a change in panied by a statement showing, by the quantity of an ingredient shown in their common or usual names, the the formula without a change in the kinds and percentages of the ingredi- order of predominance shown on the ents comprising the poultry product label, provided that the change in the and by a statement indicating the quantity of ingredients complies with method or preparation of the product any minimum or maximum limits for with respect to which the label is to be the use of such ingredients prescribed used. Approximate percentages may be in subpart P of this part and § 424.21(c) given in cases where the percentages of of subchapter E; ingredients may vary from time to (xix) Changes in the color of the la- time, if the limits of variation are stat- beling, provided that sufficient con- ed. trast and legibility remain; (xx) A change in the product vi- [37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 59 FR 45196, Sept. 1, gnette, provided that the change does 1994. Redesignated at 60 FR 67457, Dec. 29, not affect mandatory labeling informa- 1995] tion or misrepresent the content of the package; § 381.136 Affixing of official identifica- (xxi) The addition, deletion, or sub- tion. stitution of the official USDA poultry (a) No official inspection legend or grade shield; (xxii) A change in the es- any abbreviation or other simulation tablishment number by a corporation thereof may be affixed to or placed on or parent company for an establish- or caused to be affixed to or placed on ment under its ownership; any poultry product or container (xxiii) Changes in nutrition labeling thereof, except by an inspector or that only involve quantitative adjust- under the supervision of an inspector ments to the nutrition labeling infor- or other person authorized by the Ad- mation, except for services sizes, pro- ministrator, and no container bearing vided the nutrition labeling informa- any such legend shall be filled except tion maintains its accuracy and con- under such supervision. sistency; (b) No official inspection legend shall (xxiv) Deletion of any claim, and the be used on any poultry product or deletion of non-mandatory features or other article which does not qualify for non-mandatory information; such mark under the regulations. (xxv) The addition or deletion of a direct translation of the English lan- § 381.137 Evidence of labeling and de- guage into a foreign language for prod- vices approval. ucts marked ‘‘for export only’’; and No inspector shall authorize the use (xxvi) The use of the descriptive term of any device bearing any official in- ‘‘fresh’’ in accordance with spection legend unless he or she has on § 381.129(b)(6)(i) of this subchapter. file evidence that such device has been (xxvii) The use of the descriptive approved in accordance with the provi- Term frozen as required by sions of this subpart. § 381.129(b)(6)(ii) of this subchapter. (xxviii) A country of origin state- [60 FR 67458, Dec. 29, 1995] ment on any product label described in

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§ 381.138 Unauthorized use or disposi- than an official establishment, is in tion of approved labeling or de- need of relabeling because the labeling vices. has become mutilated or damaged, or (a) Labeling and devices approved for for some other reason needs relabeling, use pursuant to § 381.115 shall be used the requests for relabeling the poultry only for the purpose for which ap- product shall be sent to the Adminis- proved, and shall not be disposed of trator and accompanied with a state- from the official establishment for ment of the reasons therefor and the which approved except with written ap- quantity of labeling required. Labeling proval of the Administrator. Any unau- material intended for relabeling in- thorized use or disposition of approved spected and passed product shall not be labeling or devices bearing official in- transported from an official establish- spection marks is prohibited and may ment until permission has been re- result in cancellation of the approval. ceived from the Administrator. The re- (b) Labeling and containers bearing labeling of inspected and passed prod- any official inspection marks, with or uct with official labels shall be done without the official establishment under the supervision of an inspector number, may be transported from one pursuant to the regulations in part 362 official establishment to any other of- of this chapter. The establishment ficial establishment, only if such ship- shall reimburse the Inspection Service ments are made with the prior author- for any cost involved in supervising the ization of the inspector in charge at relabeling of such product as provided point of origin, who will notify the in- in said regulations. spector in charge at destination concerning the date of shipment, quantity, §§ 381.141–381.143 [Reserved] and type of labeling material involved. Approved labeling and containers may § 381.144 Packaging materials. be moved without restriction under (a) Edible products may not be pack- this part between official establish- aged in a container which is composed ments operated by the same person if in whole or in part of any poisonous or such labeling and containers are ap- deleterious substances which may proved for use at all such establish- render the contents adulterated or in- ments. No such material shall be used jurious to health. All packaging mate- at the establishment to which it is rials must be safe for the intended use shipped unless such use conforms with within the meaning of section 409 of the requirements of this subpart. the Federal Food, Drug, and Cosmetic Act, as amended (FFDCA). § 381.139 Removal of official identifica- (b) Packaging materials entering the tions. official establishment must be accom- (a) Every person who receives any panied or covered by a guaranty, or poultry product in containers which statement of assurance, from the pack- bear any official inspection legend aging supplier under whose brand name shall remove or deface such legend or and firm name the material is mar- destroy the containers upon removal of keted to the official establishment. such articles from the containers. The guaranty shall state that the ma- (b) No person shall alter, detach, de- terial’s intended use complies with the face, or destroy any official identifica- FFDCA and all applicable food additive tions prescribed in subpart M that were regulations. The guaranty must iden- applied pursuant to the regulations, tify the material, e.g., by the distin- unless he is authorized to do so by an guishing brand name or code designa- inspector or this section; and no person tion appearing on the packaging mate- shall fail to use any such official iden- rial shipping container; must specify tification when required by this part. the applicable conditions of use, including temperature limits and other § 381.140 Relabeling poultry products. pertinent limits specified under the When it is claimed by the operator of FFDCA and food additive regulations; an official establishment that some of and must be signed by an authorized its labeled poultry product, which has official of the supplying firm. The been transported to a location other guaranty may be limited to a specific

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shipment of an article, in which case it request—a minimum of 30 days—any may be part of or attached to the inapplicable guaranty shall cease to be voice covering such shipment, or it effective and approval to continue may be general and continuing, in using the specified packaging material which case, in its application to any in official establishments may be de- article or other shipment of an article, nied. The Administrator may extend it shall be considered to have been this time where reasonable grounds for given at the date such article was extension are shown, as, for example, shipped by the person who gives the where data must be obtained from sup- guaranty. Guaranties consistent with pliers. the Food and Drug Administration’s (e) The Administrator may dis- regulations regarding such guaranties approve for use in official establish- (21 CFR 7.12 and 7.13) will be accept- ments packaging materials whose use able. The management of the establish- cannot be confirmed as complying with ment must maintain a file containing the FFDCA and applicable food addi- guaranties for all food contact pack- tive regulations. Before approval to use aging materials in the establishment. The file shall be made available to Pro- a packaging material is finally denied gram inspectors or other Department by the Administrator, the affected offi- officials upon request. While in the of- cial establishment and the supplier of ficial establishment, the identity of all the material shall be given notice and packaging materials must be traceable the opportunity to present their views to the applicable guaranty. to the Administrator. If the official es- (c) The guaranty by the packaging tablishment and the supplier do not ac- supplier will be accepted by Program cept the Administrator’s determina- inspectors to establish that the use of tion, a hearing in accordance with ap- material complies with the FFDCA and plicable rules of practice will be held to all applicable food additive regula- resolve such dispute. Approval to use tions. the materials pending the outcome of (d) The Department will monitor the the presentation of views or hearing use of packaging materials in official shall be denied if the Administrator de- establishments to assure that the re- termines that such use may present an quirements of paragraph (a) of this sec- imminent hazard to public health. tion are met, and may question the (f) Periodically, the Administrator basis for any guaranty described under will issue to inspectors a listing, by paragraph (b) of this section. Official distinguishing brand name or code des- establishments and packaging sup- ignation, of packaging materials that pliers providing written guaranties to have been reviewed and that fail to those official establishments will be meet the requirements of paragraph (a) permitted an opportunity to provide of this section. Listed materials will information to designated Department not be permitted for use in official es- officials as needed to verify the basis tablishments. If a subsequent review of for any such guaranty. The required in- any material indicates that it meets formation will include, but is not lim- the requirements of paragraph (a), the ited to, manufacturing firm’s name, material will be deleted from the list- trade name or code designation for the ing. material, complete chemical composi- (g) Nothing in this section shall af- tion, and use. Selection of a material fect the authority of Program inspec- for review does not in itself affect a tors to refuse a specific material if he/ material’s acceptability. Materials she determines the material may may continue to be used during the re- render products adulterated or inju- view period. However, if information rious to health. requested from the supplier is not provided within the time indicated in the [49 FR 2236, Jan. 19, 1984]

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Subpart O—Entry of Articles Into spected poultry products and proc- Official Establishments; Proc- essing and other operations with re- essing Inspection and Other spect thereto from the exempted arti- Reinspections; Processing Re- cles and operations with respect there- quirements to, complete cleanup of facilities and equipment between processing of in- § 381.145 Poultry products and other spected poultry products and the ex- articles entering or at official estab- empted articles and no commingling of lishments; examination and other inspected and exempted articles in re- requirements. ceiving, holding or storage areas. (a) No poultry product (including (b) All poultry products and all car- poultry broth for use in any poultry casses, parts thereof, meat and meat product in any official establishment) food products of cattle, sheep, swine, may be brought into any official estab- goats, or equines which enter any offi- lishment unless it has been processed cial establishment shall be identified in the United States only in an official by the operator of the official estab- establishment or imported from a for- lishment at the time of receipt at the eign country listed in § 381.196(b), and inspected and passed, in accordance official establishment. All poultry with the regulations; and unless the products, and all carcasses, parts container of such product is marked so thereof, meat and meat food products as to identify the product as so in- of such animals, which are processed or spected and passed, in accordance with otherwise handled at any official estab- § 381.115 or § 381.205, except that poultry lishment shall be subject to examina- products inspected and passed and tion by an inspector at the official es- identified as such under the laws of an tablishment in such manner and at ‘‘at least equal’’ State or territory list- such times as may be deemed necessary ed in § 381.187 may be brought into any by the inspector in charge to assure official establishment solely for stor- compliance with the regulations. Upon age and distribution therefrom without such examination, if any such article repackaging, relabeling, or processing or portion thereof is found to be adul- in such establishment. No carcass, part terated, such article or portion shall, thereof, meat or meat food product of in the case of poultry products, be con- cattle, sheep, swine, goats, or equines demned and disposed of as prescribed in may be brought into an official estab- § 381.95, unless by reprocessing they lishment unless it has been prepared in may be made not adulterated, and the United States only in an official meat packing establishment, or im- shall, in the case of such other articles ported, and inspected and passed, in ac- be disposed of according to applicable cordance with the Federal Meat Inspec- law. tion Act, and the regulations under Such examination may be accom- such Act (Subchapter A of this chap- plished through use of statistically ter) and is properly marked as so in- sound sampling plans that assure a spected and passed; or has been in- high level of confidence. The inspector spected and passed and is identified as in charge shall designate the type of such in accordance with the require- plan and the program employee shall ments of the law and regulations of a select the specific plan to be used in State not designated in § 331.2 of this accordance with instructions issued by chapter; or is present in the official es- the Administrator. 1 tablishment by reason of an exemption allowed in the Federal Meat Inspection Act and the regulations under such Act 1 (Subchapter A of this chapter) or the Further information concerning sampling plans which have been adopted for specific law and regulations of a State not so products may be obtained from the Circuit designated. However, such exempted Supervisor. These sampling plans are devel- articles may enter only under condi- oped for individual products by the Wash- tions approved by the Administrator in ington staff and will be distributed for field specific cases, including but not lim- use as they are developed. The type of plan ited to, complete separation of in- Continued

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(c) Applying for Total Plant Quality also be responsible for the quality con- Control. Any owner or operator of an trol system. official establishment preparing poul- (3) A list identifying those subparts try product who has a total plant qual- and sections of the poultry products in- ity control system or plan for control- spection regulations which are applica- ling such products, after ante-mortem ble to the operations of the establish- and post-mortem inspection, through ment applying for approval of a quality all stages of preparation, may request control system. This list shall also the Administrator to evaluate it to de- identify which part of the system will termine whether or not that system is serve to maintain compliance with the adequate to result in product being in applicable regulations. compliance with the requirements of (4) Detailed information concerning the Act and therefore qualify as a U.S. the manner in which the system will Department of Agriculture (USDA) function. Such information should in- Total Plant Quality Control Establish- clude, but not necessarily be limited ment. Such a request shall, as a min- to, questions of raw material control, imum, include: the critical check or control points, (1) A letter to the Administrator the nature and frequency of tests to be from the establishment owner or oper- made, the nature of charts and other ator stating the company’s basis and records that will be used, the length of purpose for seeking an approved qual- time such charts and records will be ity control system and willingness to maintained in the custody of the offi- adhere to the requirements of the sys- cial establishment, the nature of defi- tem as approved by the Department; ciencies the quality control system is that all the establishment’s data, anal- designed to identify and control, the yses, and information generated by its parameters of limits which will be used quality control system will be main- and the points at which corrective ac- tained to enable the Department to tion will occur, and the nature of such monitor compliance and available to corrective action—ranging from the Department personnel; that plant qual- least to most severe: Provided, That ity control personnel will have author- subsequent to approval of the total ity to halt production or shipping of plant quality control system by the product in cases where the submitted Administrator, the official establish- quality control systems require it; and ment may produce a new product for that the owner or operator (or his/her test marketing provided labeling for designee) will be available for consulta- the product has been approved by the tion at any time Department personnel Administrator, the inspector in charge consider it necessary. has determined that the procedures for (2) In the case of an establishment preparing the product will assure that having one or more full-time persons all Federal requirements are met, and whose primary duties are related to the the production for test marketing does quality control system, an organiza- not exceed 6 months. Such new product tional chart showing that such people shall not be produced at that establish- ultimately report to an establishment ment after the 6-month period unless official whose quality control respon- approval of the quality control system sibilities are independent of or not pre- for that product has been received from dominantly production responsibil- the Administrator. ities. In the case of a small establish- (d)–(e) [Reserved] ment which does not have full-time (f) Labeling Logo. Owners and opera- quality control personnel, information tors of official establishments having a indicating the nature of the duties and total plant quality control system ap- responsibilities of the person who will proved under the provisions of paragraph (c) of this section, may only use, as a part of any labeling, the following applicable depends on factors such as wheth- logo. Any labeling bearing the logo and er the product is in containers, stage of preparation, and procedures followed by the es- any wording of explanation with re- tablishment operator. The specific plan ap- spect to this logo shall be approved as plicable depends on the kind of product in- required by subparts M and N of this volved. part.

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within 30 days of the date of the letter. In those instances where there is a conflict of facts, a hearing, under applicable Rules of Practice, will be afforded to the establishment owner or operator, if requested, to resolve the conflict. The Administrator’s termination of quality control approval shall remain in effect pending the final determination of the proceeding. (3) If approval of the total establishment quality control system has been terminated in accordance with the provisions of this section, an application and request for approval of the same or modified total establishment quality control system will not be evaluated by the Administrator for at least 6 (g) Termination of Quality Control Sys- months from the termination date. tems. (1) The approval of a total plant (4) If approval of a quality control quality control system may be termi- system for irradiation facilities, as nated at any time by the owner or op- specified in section 381.149 of this sub- erator of the official establishment part, has been terminated in accord- upon written notice to the Adminis- ance with the provisions of this sec- trator. tion, a request for approval of the same (2) The approval of a total plant qual- or a modified quality control system ity control system or a quality control will be evaluated by the Administrator system for irradiation facilities may be upon receipt. terminated upon the establishment’s (h)(1) Operating Schedule Under Total receipt of a written notice from the Ad- Plant Quality Control. An official estab- ministrator under the following condi- lishment with an approved total plant tions: quality control system may request ap- (i) If adulterated or misbranded poul- proval for an operating schedule of up try product is found by the to 12 consecutive hours per shift. Per- Adminstrator to have been prepared for missions will be granted provided that: or distributed in commerce by the sub- (i) The official establishment has sat- ject establishment. In such case, oppor- isfactorily operated under a total plant tunity will be provided to the estab- quality control system for at least 1 lishment owner or operator to present year. views to the Administrator within 30 (ii) All products prepared and pack- days of the date of terminating the ap- aged, or processed after the end of 8 proval. In those instances where there hours of inspection shall only be a con- is a conflict of facts, a hearing, under tinuation of the processing monitored applicable Rules of Practice, will be af- by the inspector and being conducted forded to the establishment owner or during the last hour of inspection. operator, if requested, to resolve the (iii) All immediate containers of conflict, The Administrator’s termi- products prepared and packaged shall nation of approval shall remain in ef- bear code marks that are unique to any fect pending the final determination of period of production beyond the 8 hours the proceeding. of inspection. The form of such code (ii) If the establishment fails to com- marks will remain constant from day ply with the quality control system to to day, and a facsimile of the code which it has agreed after being notified marks and their meaning shall be pro- by letter from the Administrator or his vided to the inspector. designee. Prior to such termination, (2) Application. Applications shall be opportunity will be provided to the es- submitted to the Regional Director and tablishment owner or operator to shall specify how the conditions in present views to the Administrator § 381.145(h)(1) have been or will be met.

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(3) Monitoring by Inspectors. In order are prepared, except that, upon written to verify that an establishment is pre- request, and under such conditions as paring and shipping product in accord- may be prescribed by the Adminis- ance with the approved total plant trator in specific cases, such products quality control system and the Act and may be moved from the official estab- regulations after the 8 hours of inspec- lishment prior to freezing: Provided, tion, the official establishment may be That the official establishment and provided overtime inspectiom services freezer are so located and the necessary at the discretion of the circuit super- arrangements are made so that the In- visor and charged for such services. spection Service will have access to the (i) To ensure the safe use of prepara- freezing room and adequate oppor- tions used in poultry scald water, the tunity to determine that the products label or labeling on containers of such are being properly handled and frozen. preparations shall bear adequate directions to ensure use in compliance with § 381.150 Requirements for the produc- any limitations prescribed in 21 CFR tion of fully cooked poultry prod- Chapter I, Subchapter A or Subchapter ucts and partially cooked poultry B or 9 CFR Chapter III, Subchapter A breakfast strips. or Subchapter E. (a) Fully cooked poultry products (Recordkeeping requirements approved by must be produced using processes en- the Office of Management and Budget under suring that the products meet the fol- control number 0583–0015) lowing performance standards:

[37 FR 9706, May 16, 1972, as amended at 45 (1) Lethality. A 7-log10 reduction of FR 54323, Aug. 15, 1980; 46 FR 48904, Oct. 5, Salmonella or an alternative lethality 1981; 50 FR 6, Jan. 2, 1985; 51 FR 32304, Sept. that achieves an equivalent probability 11, 1986; 57 FR 43598, Sept. 21, 1992; 62 FR 45026, Aug. 25, 1997; 62 FR 54759, Oct. 22, 1997; that no viable Salmonella organisms re- 64 FR 72175, Dec. 23, 1999; 65 FR 34390, May 30, main in the finished product, as well as 2000] the reduction of other pathogens and their toxins or toxic metabolites nec- § 381.146 Sampling at official establish- essary to prevent adulteration, must be ments. demonstrated to be achieved through- Inspectors may take, without cost to out the product. The lethality process the Department, such samples as are must include a cooking step. Con- necessary of any poultry product, or trolled intermediate step(s) applied to other article for use as an ingredient of raw product may form part of the basis any poultry product, at any official es- for the equivalency. tablishment to determine whether it (2) Stabilization. There can be no mul- complies with the requirements of the tiplication of toxigenic microorga- regulations. nisms such as Clostridium botulinum, and no more than a 1 log multiplica- § 381.148 Processing and handling re- 10 quirements for frozen poultry prod- tion of Clostridium perfringens within ucts. the product. (b) Partially cooked poultry break- Procedures with respect to processing of frozen ready-to-heat-and-eat fast strips must be produced using poultry products or stuffed ready-to- processes ensuring that the products roast poultry shall be in accordance meet the performance standard listed with sound operating practices and car- in paragraph (a)(2) of this section. La- ried out in a manner which will assure beling for these products must comply freedom from adulteration of the prod- with § 381.125. In addition, the state- ucts. Products to be frozen shall be ment ‘‘Partially Cooked: For Safety, moved into the freezer promptly under Cook Until Well Done’’ must appear on such supervision by an inspector as is the principal display panel in letters no necessary to assure preservation of the smaller than 1⁄2 the size of the largest products by prompt and efficient freez- letter in the product name. Detailed ing. Adequate freezing facilities shall cooking instructions shall be provided be provided within the official estab- on the immediate container of the lishment where products to be frozen products.

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(c) For each product produced using a of the rooms and equipment and rinsed process other than one conducted in ac- with potable water before use. cordance with the Hazard Analysis and (c) Hermetically sealed containers of Critical Control Point (HACCP) system poultry product which have been con- requirements in part 417 of this chap- taminated by polluted water shall be ter, an establishment must develop and examined promptly by the official es- have on file, available to FSIS, a proc- tablishment under supervision of an in- ess schedule, as defined in § 381.1(b). spector and rehandled as follows: Each process schedule must be ap- (1) Separate and condemn all poultry proved in writing by a process author- products in damaged or extensively ity for safety and efficacy in meeting rusted containers. the performance standards established (2) Remove paper labels and wash the for the product in question. A process remaining containers in warm soapy authority must have access to an es- water, using a brush where necessary tablishment in order to evaluate and to remove rust or other foreign mate- approve the safety and efficacy of each rial. Disinfect these containers by ei- process schedule. ther of the following methods: (d) Under the auspices of a processing (i) Immerse in a solution of sodium authority, an establishment must vali- hypochlorite containing not less than date new or altered process schedules 100 p/m of available chlorine or other by scientifically supportable means, equivalent disinfectant approved by such as information gleaned from the the Administrator, 1 rinse in potable literature or by challenge studies con- water, and dry thoroughly; or ducted outside the plant. (ii) Immerse in 212 °F. water, bring temperature of the water back to 212 [64 FR 746, Jan. 6, 1999] °F. and maintain the temperature at 212 °F. for 5 minutes, then remove con- § 381.151 Adulteration of product by polluted water; procedure for han- tainers from water and cool them to 95 dling. °F. and dry thoroughly. (3) After handling as described in (a) In the event there is polluted paragraph (c)(2) of this section, the water (including but not limited to containers may be relacquered, if nec- flood water) in an official establish- essary, and then relabeled with ap- ment, all poultry products and ingredi- proved labels applicable to the product ents for use in the preparation of such therein. products that have been rendered adul- (4) The identity of the canned poultry terated by the water shall be con- product shall be maintained through- demned. out all stages of the rehandling oper- (b) After the polluted water has re- ations, to insure correct labeling of ceded from an official establishment, containers. all walls, ceilings, posts, and floors of the rooms and compartments involved, [38 FR 34456, Dec. 14, 1973] including the equipment therein, shall, under the supervision of an inspector, § 381.152 Preparation in an official establishment of articles not for be cleaned thoroughly by the official human food. establishment personnel. An adequate supply of hot water under pressure is (a) Requirements applicable when pre- essential to make such cleaning effec- pared in an edible products department. tive. After cleaning a solution of so- When an article (including, but not dium hypochlorite containing approxi- being limited to, animal food) that is mately one-half of 1 percent available not for use as human food is prepared chlorine (5,000 p/m) or other equivalent in any room or compartment, in an of- disinfectant approved by the Adminis- ficial establishment where poultry trator 1 shall be applied to the surface products are prepared or handled (such room or compartment being herein referred to as an ‘‘edible products depart- 1 A list of approved disinfectants is available upon request to Scientific Services, ment’’), sufficient space and equipment Meat and Poultry Inspection Program, Food shall be provided to assure that the Safety and Inspection Service, U.S. Depart- preparation of the article in no way ment of Agriculture, Washington, DC 20250. interferes with the preparation or

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other handling of the poultry products. shall be allotted and adequate equip- Where necessary, separate equipment ment and facilities provided so that the shall be provided for the preparation of preparation of the article does not the article. To assure the maintenance interfere with the preparation of poul- of the requisite sanitary conditions in try products or the maintenance of the the edible products department, the op- requisite sanitary conditions in the of- erations incident to the preparation of ficial establishment. The preparation the article shall be subject to the same of any such article shall be subject to sanitary requirements as apply to the supervision by an inspector. handling of poultry products in the edi- (c) Containers to be labeled. The imme- ble products department. Preparation diate container of any such article that of the article shall be limited to those is prepared in an official establishment hours during which the official estab- shall be conspicuously labeled so as to lishment operates under the super- distinguish it from human food. Such vision of an inspector. The ingredients articles are also subject to the require- used in the preparation of the article ments under the Federal Food, Drug, shall, unless otherwise approved by the and Cosmetic Act. Administrator in specific cases, be such as may be used in the preparation of a § 381.153 [Reserved] poultry product. The article may be stored in, and distributed from, the edi- Subpart P—Definitions and Stand- ble products department if the article ards of Identity or Composi- is properly identified. tion (b) Requirements applicable when prepared in an inedible products department. § 381.155 General. When an article (including, but not (a) Authorization to establish specifica- being limited to, animal food) that is tions. (1) The Administrator is author- not for use as human food, is prepared ized to establish specifications or defi- in any part of an official establishment nitions and standards of identity or other than an edible products depart- composition, covering the principal ment (such part of the establishment constituents of any poultry product being herein referred to as the ‘‘ined- with respect to which a specified name ible products department’’), the area in of the product or other labeling termi- which such article is prepared shall be nology may be used, whenever he de- distinctly separated from all edible termines such action is necessary to products departments. Poultry prod- prevent sale of the product under false ucts and inedible products may be or misleading labeling. Further, the brought from any edible products de- Administrator is authorized to pre- partment into any inedible products scribe definitions and standards of department, but no poultry product or identity or composition for poultry inedible product may be brought from products whenever he determines such an inedible products department into action is otherwise necessary for the an edible products department except protection of the public. The require- that any such articles as are in sealed ments of this subpart are hereby found containers or are handled under condi- to be necessary for these purposes and tions prescribed or approved by the Ad- standards are hereby established as set ministrator in specific cases may be forth in this subpart. brought into an edible products depart- (2) Where cooked poultry meat is ment. Diseased carcasses or diseased specified in this subpart as an ingre- parts of any carcass shall not be used dient of poultry products, this means in the preparation of any animal food poultry meat derived from poultry unless they have been treated in the processed, cooked, and cooled in a man- manner prescribed in § 381.95(a). Trucks ner approved by the Administrator in or containers used for the transpor- specific cases without use of liquid or tation of poultry products or inedible moisture in direct contact with the products into an inedible products de- poultry meat following the cooking partment shall be cleaned before being and cooling of the poultry. returned to or brought into an edible (3) If, following cooking and cooling products department. Sufficient space of poultry meat to be used in poultry

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products, liquid or moisture is used in beled ‘‘Boned (Kind)—Solid Pack,’’ but direct contact with such poultry meat may be added in quantities not in ex- and the percentage of solids, excluding cess of a total of 0.5 percent of the salt, in the poultry meat is found to be total ingredients in the preparation of below 34 percent when such poultry other canned boned poultry products meat is tested by acceptable methods, and in such cases the common name of the percentage of poultry meat re- the substance shall be included in the quired by this section for any poultry name of the product, e.g., ‘‘Boned product shall be increased in propor- Chicken with Broth—Gelatin Added.’’ tion to the deficiency, or the meat (b) Canned boned poultry, except shall be so processed as to raise the sol- poultry within paragraph (c) of this ids content, excluding salt, to 34 per- section, shall meet the requirements cent. The official establishment shall set forth in Table II. The percentages furnish adequate facilities for such in Table II shall be calculated on the testing. basis of the total ingredients used in (b) Any binder or antimicrobial agent the preparation of the product. that has been found to be safe and suit- (c) Canned boned poultry with nat- able by the Food and Drug Administra- ural juices (Boned (Kind) with natural tion and the Food Safety and Inspec- juices) shall be prepared from either tion Service may be used in the produc- raw boned poultry or a mixture of raw tion of poultry products with standards boned poultry and cooked boned poul- of identity in this part, where the prod- try and shall have no liquid added dur- uct standards and applicable Federal ing the preparation of the product. regulations already permit the use of (d) Canned shredded poultry (Shred- these types of ingredients. ded Kind), consists of poultry meat re- [37 FR 9706, May 16, 1972, as amended at 68 duced to a shredded appearance, from FR 22578, Apr. 29, 2003] the kind of poultry indicated, with meat, skin, and fat not in excess of the § 381.156 Poultry meat content stand- natural whole carcass proportions. ards for certain poultry products. Canned shredded poultry from specific Poultry products with labeling ter- parts may include skin or fat in excess minology as set forth in Table I shall of the proportions normally found on a comply with the specifications for per- whole carcass, but not in excess of the cent light meat and percent dark meat proportions of skin and fat normal to set forth in said table. the particular part or parts; and such product shall be labeled in accordance TABLE I with § 381.117(d). Percent light Percent dark (e) Canned boned poultry shall be Label terminology meat meat prepared as set forth in Table II, items 1, 2, 3, or 4, whichever is applicable. Natural proportions ...... 50–65 ...... 50–35. Light or white meat ...... 100 ...... 0. Dark meat ...... 0 ...... 100. TABLE II Light and dark meat ..... 51–65 ...... 49–35. Dark and light meat ..... 35–49 ...... 65–51. Minimum Mostly white meat ...... 66 or more ...... 34 or less. percent Mostly dark meat ...... 34 or less ...... 66 or more. cooked, deboned Maximum poultry meat percent liq- Product name of kind indi- uid that [37 FR 9706, May 16, 1972, as amended at 39 may be cated, with 1 FR 4569, Feb. 5, 1974] skin, fat, added and seasoning § 381.157 Canned boned poultry and baby or geriatric food. 1. Boned (Kind)—solid pack ...... 95 5 2. Boned (Kind) ...... 90 10 (a) Canned boned poultry shall, un- 3. Boned (Kind) with broth 2 ...... 80 20 less otherwise specified in this section, 4. Boned (Kind) (ll) percent be prepared from cooked deboned poul- broth 2,3 ...... 50 50 try meat and may contain skin and fat 1 Liquid may be in the form of, but is not limited to, broth or not in excess of natural whole carcass extractives. 2 Alternatively, product may be prepared from raw boned proportions. Gelatin, stabilizers, or poultry in combination with cooked boned poultry so long as similar solidifying or emulsifying the product complies with the specified standard. 3 Total amount of liquid added shall be included in the name agents shall not be added to product la- of the product; e.g., ‘‘Boned Chicken with 25 percent broth.’’

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(f) Poultry products intended for in- I, Subchapter A or Subchapter B. In ad- fant or geriatric use and represented as dition to the binders referred to in the having a ‘‘high meat’’ content shall preceding sentence, the following sub- contain not less than 18.75 percent stances are permitted for use as bind- cooked, deboned poultry meat of the ers in poultry rolls: transglutaminase kind indicated, with seasoning. enzyme at up to 65 ppm. When binding agents are added in excess of 3 percent TABLE IIA for cooked rolls and 2 percent for raw Minimum rolls, the common name of the agent or percent cooked, Maximum the term ‘‘Binders Added’’ shall be in- deboned, percent liq- cluded in the name of the product; e.g., Product name poultry meat uid that may be ‘‘Turkey Roll-Gelatin Added.’’ of kind indi- 1 cated, with added (b) With respect to heat processed seasoning rolls, 2 percent or less liquid based on 1. Strained or chopped (Kind) the weight of the finished product with broth 2,3 ...... 43 57 without liquid may remain with or be 2. High meat dinner 3 ...... 18.75 returned to product labeled as ‘‘(Kind) 1 Liquid may be in the form of, but not limited to, broth or extractives. Roll.’’ 2 Alternatively, product may be prepared from raw boned (c) Heat processed rolls which have poultry meat in combination with cooked bone poultry meat so long as the product complies with the specified standard. more than 2 percent liquid remaining 3 Label must indicate in some manner that product is for in- with or returned to the product shall fant or geriatric servings. be labeled as ‘‘(Kind) Roll with Natural [37 FR 9706, May 16, 1972, as amended at 39 Juices.’’ If more than 2 percent of any FR 4569, Feb. 5, 1974] liquid other than natural cookout juices is added, the product must be la- § 381.158 Poultry dinners (frozen) and beled to indicate that fact; e.g., ‘‘Tur- pies. key Roll with Broth.’’ Liquid shall not Poultry dinners (frozen) and pies be returned or added to product within shall meet the requirements set forth this paragraph graph in excess of the in Table III of this section and the per- amount normally cooked out during centage or weight specified therein preparation. shall be calculated on the basis of total ingredients used in the preparation of [37 FR 9706, May 16, 1972, as amended at 55 the poultry product. FR 34684, Aug. 24, 1990; 66 FR 54916, Oct. 31, 2001] TABLE III § 381.160 (Kind) burgers; (Kind) pat- Minimum cooked Minimum raw ties. deboned poultry deboned poultry meat of kind indi- meat of kind indi- Such product consists of 100 percent cated cated poultry of the kind indicated, with Per- Per- skin and fat not in excess of natural cent Weight cent Weight proportions. Product containing fillers (Kind) Pies ...... 14 or 11⁄8 oz. 25 or 2 oz. or binders shall be named ‘‘(Kind) Pat- per 8-oz. per 8-oz. pie 1 pie. 1 ties.’’ (Kind) Dinners ...... 18 or 2 oz.2,3 § 381.161 ‘‘(Kind) A La Kiev.’’ 1 14 percent or 11⁄8 oz., whichever is greater; or 25 percent or 2 oz., whichever is greater. Such product consists of poultry 2 Excluding weight of appetizers, desserts, etc. 3 18 percent or 2 oz., whichever is greater. A minimum of meat of the kind indicated, stuffed 45 percent, or 5 ounces per dinner, whichever is greater, of cooked poultry including bone and breading may be used in with butter which may be seasoned and lieu of minimum 18 percent or 2 ounces of cooked deboned the product may be wrapped in suffi- poultry meat and the cooked poultry including bone and breading shall not contain more than 30 percent breading. cient skin to cover the meat. It may be dipped in batter, fried, and frozen. § 381.159 Poultry rolls. (a) Binders or extenders may be § 381.162 ‘‘(Kind) steak or fillet.’’ added in accordance with a regulation Such product consists of a boneless in this subchapter, in 9 CFR Chapter slice or strip of poultry meat of the III, Subchapter E, or in 21 CFR Chapter kind indicated.

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§ 381.163 ‘‘(Kind) baked’’ or ‘‘(Kind) TABLE IV—Continued roasted.’’ Minimum Minimum Such product consists of ready-to- percent percent cooked cooked cook poultry of the kind indicated, Product name 1 deboned poultry of that has been cooked in dry source poultry meat kind indi- of kind indicated, indi- heat, e.g., oven roasted or oven baked. cated cating bone

§ 381.164 ‘‘(Kind) barbecued.’’ (Kind) Noodles or Dumplings 2 .. 15 30 (Kind) with Vegetables ...... 15 ...... Such product consists of ready-to- Gravy with sliced (Kind) ...... 15 ...... cook poultry of the kind indicated, (Kind) Tetrazzini ...... 15 ...... that has been cooked in dry heat and (Kind) chili with beans ...... 17 ...... Creamed (Kind) ...... 20 ...... basted with a seasoned sauce. (Kind) Cacciatore ...... 20 40 (Kind) Fricassee ...... 20 40 § 381.165 ‘‘(Kind) barbecued prepared (Kind) A-La-King ...... 20 ...... with moist heat.’’ (Kind) croquettes ...... 25 ...... Slice (Kind) with Gravy and Such product consists of ready-to- Dressing ...... 25 ...... cook poultry of the kind indicated that (Kind) Salad 3 ...... 25 ...... has been cooked by the action of moist (Kind) chili ...... 28 ...... (Kind) Hash ...... 30 ...... heat in a barbecue sauce. Sliced (Kind) with Gravy ...... 35 ...... Minced (Kind) Barbecue ...... 40 ...... § 381.166 Breaded products. 1 The product name may contain other appropriate descrip- ‘‘Breaded’’ is a term applicable to tive terms such as ‘‘noodle’’; e.g., ‘‘Chicken Noodle Soup.’’ 2 This standard also applies to products named (Kind) with any poultry product which is coated rice or similar starches. with breading or a batter and breading 3 The 25 percent-standard listed includes poultry meat plus proportions of skin and fat natural to the poultry used. in an amount not to exceed 30 percent of the weight of the finished breaded [37 FR 9706, May 16, 1972, as amended at 39 product. FR 4569, Feb. 5, 1974]

§ 381.167 Other poultry dishes and spe- § 381.168 Maximum percent of skin in cialty items. certain poultry products. Poultry dishes and specialty items The poultry products listed in Table listed in Table IV of this paragraph V shall have not more than the percent shall meet the requirements set forth of skin specified in the table, when raw in said table, irrespective of the type of and when cooked. packaging, and the percentages in Table IV shall be calculated on a TABLE V ready-to-serve basis, except that soup Percent skin bases in institutional packs which are Product name prepared for sale to institutional users Raw Cooked shall have a minimum of 15 percent Boneless Turkey Breast cooked deboned poultry meat based on or the weight of the soup base product. Boneless Turkey Breast Roll ...... 14 Boneless Turkey Thigh or TABLE IV Boneless Turkey Thigh Roll ...... 8 Boneless Turkey Minimum Minimum or percent percent cooked cooked Turkey Roll ...... 15 Product name 1 deboned poultry of Boneless Chicken Breast poultry meat kind indi- or of kind indicated, indi- Boneless Chicken Breast Roll ...... 18 20 cated cating bone Boneless Chicken or (Kind) Ravioli ...... 2 ...... Chicken Roll ...... 20 25 (Kind) Soup ...... 2 ...... Chop Suey with (Kind) ...... 2 ...... (Kind) Chop Suey ...... 4 ...... § 381.169 Ready-to-cook poultry prod- (Kind) Chow Mein without noo- ucts to which solutions are added. dles ...... 4 ...... (Kind) Tamales ...... 6 ...... (a) Butter alone, or solutions of poul- Noodles or Dumplings with try broth, poultry stock, water, or edi- (Kind) 2 ...... 6 ...... (Kind) Stew ...... 12 ...... ble fats, or mixtures thereof, in which (Kind) Fricassee of Wings ...... 40 are included functional substances

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such as spices, flavor enhancers, emul- turkey and proportionately smaller for sifiers, phosphates, coloring materials, other poultry products. The remainder or other substances, approved by the of the solution ingredients shall be de- Administrator in specific cases, may be clared in type at least one-eighth inch introduced by injection into the thick in height. The entire statement must muscles (breast and legs) of ready-to- be printed in a color that contrasts cook poultry carcasses and may be in- with the background and be displayed troduced by injection or marinating on the principal display panel. into any separate bone-in part there- (c) Approval for use of a label for from, for the purpose of providing a product under this section depends basting medium or similar function. upon the ability of the processor to The ingredients of the added materials control the finished product, within a and the manner of addition to the prod- range of three-tenths of 1 percent accu- ucts must be found acceptable by the racy, so that the average percent of Administrator, in all cases. The intro- basting material in each outgoing lot duction of the added materials shall in- is not greater than 3.3 percent or less crease the weight of the processed than 2.7 percent of basting material product by approximately 3 percent when tested by an approved plant con- over the weight of the raw product trol procedure would be in compliance. after washing and chilling in compli- As used in this section, ‘‘a lot’’ may be ance with § 381.66. The weight of the any reasonable portion of production added materials introduced into the designated by the operator of the offi- poultry products as provided in this cial establishment, with a maximum of paragraph shall be included as part of an entire shift’s production from one the weight of the poultry for purposes production line. The control procedures of the net weight labeling provisions in to be eligible for approval by the Ad- § 381.121(b). ministrator must: (b) A raw poultry product, into which (1) Assure compliance with all label- added materials are introduced as pro- ing requirements. vided in paragraph (a) of this section (2) Control the variability of the must be labeled with a conspicuous, amount of added approved solution legible, and descriptive name, includ- within the limits defined above. ing terms that concisely describe the (3) Provide for the disposition in ac- method of addition and function of the cordance with the regulations of all added material. All major terms in the products not in compliance with this product name must be printed with the section. same prominence, except that the (4) Incorporate a system of raw words which describe the function of weight identification of a sufficient the added materials (such as ‘‘Injected number of poultry and/or poultry parts for Flavored Basting’’) may be more to allow effective monitoring of the prominent, provided this does not de- system by Federal inspectors and offi- tract from the conspicuousness of the cial establishment employees. other terms in the product name (such [37 FR 9706, May 16, 1972, as amended at 39 as ‘‘Young Turkey’’). The label must FR 36000, Oct. 7, 1974] also bear a statement, in bold type, immediately below and adjacent to the § 381.170 Standards for kinds and product name, listing the common or classes, and for cuts of raw poultry. usual names of the added materials in (a) The following standards specify descending order of predominance. The the various classes of the specified first part of this statement must con- kinds of poultry, and the requirements sist of terms adequate to inform con- for each class: sumers about the amount and manner (1) Chickens—(i) Rock Cornish game of introduction of the solution (such as hen or Cornish game hen. A Rock Cor- ‘‘Injected with approximately 3 percent nish game hen or Cornish game hen is of a solution of lllll’’), and must a young immature chicken (usually 5 be printed at least one-fourth the size to 6 weeks of age) weighing not more of the most prominent letter in the than 2 pounds ready-to-cook weight, product name, with a minimum size of which was prepared from a Cornish one-fourth inch for a ready-to-cook chicken or the progeny of a Cornish

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chicken crossed with another breed of under 15 months of age) that is reason- chicken. ably tender-meated and with reason- (ii) Rock Cornish fryer, roaster, or hen. ably smooth-textured skin. Sex des- A Rock Cornish fryer, roaster, or hen is ignation is optional. the progeny of a cross between a pure- (iv) Mature turkey or old turkey (hen or bred Cornish and a purebred Rock tom). A mature or old turkey is an old chicken, without regard to the weight turkey of either sex (usually in excess of the carcass involved; however, the of 15 months of age) with coarse skin term ‘‘fryer,’’ ‘‘roaster,’’ or ‘‘hen’’ shall and toughened flesh. apply only if the carcasses are from (3) Ducks—(i) Broiler duckling or fryer birds with ages and characteristics duckling. A broiler duckling or fryer that qualify them for such designation duckling is a young duck (usually under paragraph (a)(1) (iii) or (iv) of under 8 weeks of age), of either sex, this section. that is tender-meated and has a soft (iii) Broiler or fryer. A broiler or fryer bill and soft windpipe. is a young chicken (usually under 13 (ii) Roaster duckling. A roaster weeks of age), of either sex, that is ten- duckling is a young duck (usually der-meated with soft, pliable, smooth- under 16 weeks of age), of either sex, textured skin and flexible breastbone that is tender-meated and has a bill cartilage. that is not completely hardened and a (iv) Roaster or roasting chicken. A bird windpipe that is easily dented. of this class is a young chicken (usu- (iii) Mature duck or old duck. A ma- ally 3 to 5 months of age), of either sex, ture duck or an old duck is a duck that is tender-meated with soft, pli- (usually over 6 months of age), of ei- able, smooth-textured skin and breast- ther sex, with toughened flesh, hard- bone cartilage that may be somewhat ened bill, and hardened windpipe. less flexible than that of a broiler or (4) Geese—(i) Young goose. A young fryer. goose may be of either sex, is tender- (v) Capon. A capon is a surgically meated, and has a windpipe that is eas- unsexed male chicken (usually under 8 ily dented. months of age) that is tender-meated (ii) Mature goose or old goose. A ma- with soft, pliable, smooth-textured ture goose or old goose may be of ei- skin. ther sex and has toughened flesh and (vi) Hen, fowl, or baking or stewing. A hardened windpipe. bird of this class is a mature female (5) Guineas—(i) Young guinea. A chicken (usually more than 10 months young guinea may be of either sex, is of age) with meat less tender than that tender-meated, and has a flexible of a roaster, or roasting chicken and breastbone cartilage. nonflexible breastbone tip. (ii) Mature guinea or old guinea. A ma- (vii) Cock or rooster. A cock or rooster ture guinea or an old guinea may be of is a mature male chicken with coarse either sex, has toughened flesh, and a skin, toughened and darkened meat, hardened breastbone. and hardened breastbone tip. (b) The following standards specify (2) Turkeys—(i) Fryer-roaster turkey. A the requirements for the specified cuts fryer-roaster turkey is a young imma- of poultry: ture turkey (usually under 16 weeks of (1) ‘‘Breasts’’ shall be separated from age), of either sex, that is tender- the back at the shoulder joint and by a meated with soft, pliable, smooth-tex- cut running backward and downward tured skin, and flexible breastbone car- from that point along the junction of tilage. the vertebral and sternal ribs. The ribs (ii) Young turkey. A young turkey is a may be removed from the breasts, and turkey (usually under 8 months of age) the breasts may be cut along the that is tender-meated with soft, pli- breastbone to make two approximately able, smooth-textured skin, and breast- equal halves; or the wishbone portion, bone cartilage that is somewhat less as described in paragraph (b)(3) of this flexible than in a fryer-roaster turkey. section, may be removed before cutting Sex designation is optional. the remainder along the breastbone to (iii) Yearling turkey. A yearling tur- make three parts. Pieces cut in this key is a fully matured turkey (usually manner may be substituted for lighter

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or heavier pieces for exact weight-mak- (8) ‘‘Backs’’ shall include the pelvic ing purposes and the package may con- bones and all the vertebrae posterior to tain two or more of such parts without the shoulder joint. The meat shall not affecting the appropriateness of the la- be peeled from the pelvic bones. The beling as e.g., ‘‘chicken breasts.’’ Neck vertebral ribs and/or scapula may be skin shall not be included with the removed or included without affecting breasts, except that ‘‘turkey breasts’’ the appropriateness of the name. Skin may include neck skin up to the whisk- shall be substantially intact. er. (9) ‘‘Stripped backs’’ shall include the (2) ‘‘Breasts with ribs’’ shall be sepa- vertebrae from the shoulder joint to rated from the back at the junction of the tail, and include the pelvic bones. the vertebral ribs and back. Breasts The meat may be stripped off of the with ribs may be cut along the breast- pelvic bones. bone to make two approximately equal (10) ‘‘Necks’’, with or without neck halves; or the wishbone portion, as de- skin, shall be separated from the car- scribed in paragraph (b)(3) of this sec- cass at the shoulder joint. tion, may be removed before cutting (11) ‘‘Halves’’ are prepared by making the remainder along the breastbone to a full-length back and breast split of an make three parts. Pieces cut in this eviscerated poultry carcass so as to manner may be substituted for lighter produce approximately equal right and or heavier pieces for exact weight-mak- left sides. ing purposes and the package may con- (12) ‘‘Quarters’’ consist of the entire tain two or more of such parts without eviscerated poultry carcass, which has affecting the appropriateness of the la- been cut into four equal parts, but ex- beling as ‘‘breasts with ribs.’’ Neck cluding the neck. skin shall not be included, except that (13) ‘‘Breast quarter’’ consists of half ‘‘turkey breasts with ribs’’ may include a breast with the wing and a portion of neck skin up to the whisker. the back attached. (3) ‘‘Wishbones’’ (Pulley Bones), with (14) ‘‘Breast quarter without wing’’ covering muscle and skin tissue, shall consists of a front quarter of a poultry be severed from the breast approxi- carcass, from which the wing has been mately halfway between the end of the removed. wishbone (hypocledium) and front (15) ‘‘Leg quarter’’ consists of a poul- point of the breastbone (cranial process try thigh and drumstick, with a por- of the sternal crest) to a point where tion of the back attached. the wishbone joins the shoulder. Neck (16) ‘‘Thigh with back portion’’ con- skin shall not be included with the sists of a poultry thigh with back por- wishbone. tion attached. (4) ‘‘Drumsticks’’ shall be separated (17) ‘‘Legs with pelvic bone’’ consists from the thigh by a cut through the of a poultry leg with adhering meat knee joint (femorotibial and patellar and skin and pelvic bone. joint) and from the hock joint (tarsal (18) ‘‘Wing drummette’’ consists of joint). the humerus of a poultry wing with ad- (5) ‘‘Thighs’’ shall be disjointed at hering skin and meat attached. the hip joint and may include the pel- (19) ‘‘Wing portion’’ consists of a vic meat, but shall not include the pel- poultry wing except that the vic bones. Back skin shall not be in- drummette has been removed. cluded. (20) ‘‘Cut-up Poultry’’ is any cut-up (6) ‘‘(Kind) legs’’ shall be the poultry or disjointed portion of poultry or any product which includes the thigh and edible part thereof, as described in this the drumstick, i.e., the whole leg, and section. may include the pelvic meat, but shall (21) ‘‘Giblets’’ consist of approxi- not include the pelvic bones. Back skin mately equal numbers of hearts, giz- shall not be included. zards, and livers, as determined on a (7) ‘‘Wings’’ shall include the entire count basis. wing with all muscle and skin tissue (22) ‘‘Major portions’’ of eviscerated intact, except that the wingtip may be poultry carcasses are either carcasses removed. from which parts may be missing, or

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the front or rear portions of trans- (iv) Mature or old (hen or tom) turkey. A versely-split carcasses. ‘‘mature turkey’’ or ‘‘old turkey’’ is an adult turkey (more than 15 months of age), of ei- [37 FR 9706, May 16, 1972, as amended at 39 ther sex, with coarse skin and toughened FR 4569, Feb. 5, 1974; 63 FR 48960, Sept. 11, flesh. Sex designation is optional. 1998] (3) Ducks—(i) Duckling. A ‘‘duckling’’ is a EFFECTIVE DATE NOTE: At 76 FR 68064, Nov. young duck (less than 8 weeks of age), of ei- 3, 2011, § 381.170 was amended by revising ther sex, that is tender-meated and has a paragraph (a), effective Jan. 1, 2014. For the soft bill and soft windpipe. convenience of the user, the revised text is (ii) Roaster duck. A ‘‘roaster duck’’ is a set forth as follows: young duck (less than 16 weeks of age), of either sex, that is tender-meated and has a bill § 381.170 Standards for kinds and classes, that is not completely hardened and a wind- and for cuts of raw poultry. pipe that is easily dented. (a) The following standards specify the var- (iii) Mature duck or old duck. A ‘‘mature ious classes of the specified kinds of poultry duck’’ or an ‘‘old duck’’ is an adult duck and the requirements for each class: (more than 6 months of age), of either sex, (1) Chickens—(i) Rock Cornish game hen or with toughened flesh, a hardened bill, and a Cornish game hen. A ‘‘Rock Cornish game hardened windpipe. hen’’ or ‘‘Cornish game hen’’ is a young, im- (4) Geese—(i) Young goose. A ‘‘young goose’’ mature chicken (less than 5 weeks of age), of is an immature goose, of either sex, that is either sex, with a ready-to-cook carcass tender-meated and has a windpipe that is weight of not more than 2 pounds. easily dented. (ii) Broiler or fryer. A ‘‘broiler’’ or ‘‘fryer’’ (ii) Mature goose or old goose. A ‘‘mature is a young chicken (less than 10 weeks of goose’’ or ‘‘old goose’’ is an adult goose, of age), of either sex, that is tender-meated either sex, that has toughened flesh and a with soft, pliable, smooth-textured skin and hardened windpipe. flexible breastbone cartilage. (iii) Roaster or roasting chicken. A ‘‘roaster’’ (5) Guineas—(i) Young guinea. A ‘‘young or ‘‘roasting chicken’’ is a young chicken guinea’’ is an immature guinea, of either sex, (between 8 and 12 weeks of age), of either sex, that is tender-meated and has a flexible with a ready-to-cook carcass weight of 5 breastbone cartilage. pounds or more, that is tender-meated with (ii) Mature guinea or old guinea. A ‘‘mature soft, pliable, smooth-textured skin and guinea’’ or ‘‘old guinea’’ is an adult guinea, breastbone cartilage that is somewhat less of either sex, that has toughened flesh and a flexible than that of a broiler or fryer. non-flexible breastbone. (iv) Capon. A ‘‘capon’’ is a surgically neutered male chicken (less than 4 months of * * * * * age) that is tender-meated with soft, pliable, smooth-textured skin. § 381.171 Definition and standard for (v) Hen, fowl, baking chicken, or stewing ‘‘Turkey Ham.’’ chicken. A ‘‘hen,’’ ‘‘fowl,’’ ‘‘baking chicken,’’ or ‘‘stewing chicken’’ is an adult female (a) ‘‘Turkey Ham’’ shall be fabricated chicken (more than 10 months of age) with from boneless, turkey thigh meat with meat less tender than that of a roaster or skin and the surface fat attached to roasting chicken and a nonflexible breast- the skin removed. The thighs shall be bone tip. (vi) Cock or rooster. A ‘‘cock’’ or ‘‘rooster’’ that cut of poultry described in is an adult male chicken with coarse skin, § 381.170(b)(5) of this part. toughened and darkened meat, and a non- (b) The product may or may not be flexible breastbone tip. smoked, and shall be cured using one (2) Turkeys—(i) Fryer-roaster turkey. A or more of the approved curing agents ‘‘fryer-roaster turkey’’ is an immature tur- as provided in a regulation permitting key (less than 12 weeks of age), of either sex, that use in this subchapter or 9 CFR that is tender-meated with soft, pliable, smooth-textured skin, and flexible breast- Chapter III, Subchapter E, or in 21 CFR bone cartilage. Chapter I, Subchapter A or Subchapter (ii) Young turkey. A ‘‘young turkey’’ is a B. The product may also contain cure turkey (less than 8 months of age), of either accelerators, phosphates, and flavoring sex, that is tender-meated with soft, pliable, agents as provided in a regulation per- smooth-textured skin and breastbone car- mitting that use in this subchapter or tilage that is less flexible than that of a 9 CFR Chapter III, Subchapter E, or in fryer-roaster turkey. (iii) Yearling turkey. A ‘‘yearling turkey’’ is 21 CFR Chapter I, Subchapter A or a turkey (less than 15 months of age), of ei- Subchapter B; common salt, sugars, ther sex, that is reasonably tender-meated spices, spice extractives, dehydrated with reasonably smooth-textured skin. garlic, and dehydrated onions; and

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water for purpose of dissolving and dis- § 381.172 Requirements for substitute persing the substances specified above. standardized poultry products (c) The cooked finished product named by use of an expressed nutri- weight shall be no more than the origi- ent content claim and a standard- nal weight of the turkey thigh meat ized term. used prior to curing. (a) Description. The poultry products (d) The product name on the label prescribed by this general definition shall show the word ‘‘Turkey’’ in the and standard of identity are those same size, style, color, and with the products that substitute, in accordance same background as the word ‘‘Ham’’ with § 381.413(d), for a standardized and shall precede and be adjacent to it. product defined in this subpart and use (e) The product name shall be quali- the name of that standardized product fied with the statement ‘‘Cured Turkey in their statements of identity, but Thigh Meat.’’ The qualifying statement that do not comply with the estab- shall be contiguous to the product lished standard because of a name, without intervening type or de- compositional deviation that results from reduction of a constituent that is signs, shall be not less than one-half described by an expressed nutrient con- the size of the product name but not tent claim that has been defined by less than one-eighth inch in height, regulation in this subpart. The ex- and shall be in the same style and color pressed nutrient content claim shall and with the same background as the comply with the requirements of product name. § 381.413 and with the requirements in (f) If the product is fabricated from subpart Y of this part which define the pieces of turkey thigh meat that result particular nutrient content claim that from the cutting through the muscle is used. The poultry product shall com- (as opposed the whole thighs intact or ply with the relevant standard in this whole thighs with some incidental sep- part in all other respects, except as aration of muscle tissue during re- provided in paragraphs (b) and (c) of moval of the bone), the product name this section. shall be further qualified by a descrip- (b) Performance characteristics. The tive statement. The product name of performance characteristics, such as product fabricated from such pieces of physical properties, functional prop- turkey thigh meat equivalent in size to erties, and shelf-life, of the poultry a one-half inch cube or greater shall be product shall be similar to those of the further qualified to specify that the standardized poultry product produced product is ‘‘Chunked and Formed.’’ The under subpart P of this part. If there is product name of product fabricated a significant difference in a perform- from such pieces of turkey thigh meat ance characteristic that materially smaller than the equivalent of a one- limits the use of the product compared half inch cube shall be further qualified to the use of the standardized product to specify that the product is ‘‘Ground defined in subpart P of this part, the and Formed’’ or ‘‘Chopped and label shall include a statement in ac- Formed’’ as appropriate. The quali- cordance with § 381.413(d)(1) and (2) of fying statement shall immediately fol- this part, that informs the consumer of low and be contiguous to the statement such differences (e.g., if appropriate, required in paragraph (e) of this sec- ‘‘not recommended for frozen storage’’ tion, and shall be not less than one-half or ‘‘not suitable for roller grilling’’). the size of the product name but not Deviations from the ingredient provisions of the standard must be the min- less than one-eighth inch in height, imum necessary to qualify for the nu- and shall be in the same style and color trient content claim, while maintain- and with the same background as the ing similar performance characteris- product name. tics. [44 FR 51190, Aug. 31, 1979; 64 FR 72175, Dec. (c) Ingredients used in substitute prod- 23, 1999] ucts. (1) Ingredients used in the product shall be those ingredients provided for in the standard as defined in subpart P

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of this part, except that safe and suit- ardized product) or ‘‘**Ingredients in able ingredients permitted for use in excess of amounts permitted in regular poultry products as provided in a regu- lllll’’ (the blank shall be filled in lation permitting that use in this sub- with the name of the traditional stand- chapter or in 9 CFR Chapter III, Sub- ardized product), or both, as appro- chapter E, or in 21 CFR Chapter I, Sub- priate, shall immediately follow the in- chapter A or Subchapter B, may be gredients statement in the same type used at the minimum level necessary and size. to improve texture and prevent syn- [70 FR 33818, June 10, 2005] eresis, so that the substitute product is not inferior in performance character- § 381.173 Mechanically Separated istics from the standardized product (Kind of Poultry). defined in subpart P of this part for (a) ‘‘Mechanically Separated (Kind of which it is a substitute. Poultry)’’ is any product resulting (2) An ingredient that is specifically from the mechanical separation and re- required by the standard prescribed in moval of most of the bone from at- subpart P of this part shall not be re- tached skeletal muscle and other tissue placed or exchanged with a similar in- of poultry carcasses and parts of car- gredient from another source, for ex- casses that has a paste-like form and ample, extruded turnips shall not re- consistency, that may or may not con- place noodles in poultry with noodles. tain skin with attached fat and meet- (3) An ingredient that is specifically ing the other provisions of this section. prohibited from use in any poultry Examples of such product are ‘‘Me- product by subpart P of this part shall chanically Separated Chicken’’ and not be added to the substitute poultry ‘‘Mechanically Separated Turkey.’’ product under this section. (b) ‘‘Mechanically Separated (Kind of (4) Unless otherwise specified in this Poultry)’’ shall not have a bone solids part, a substitute poultry product must content of more than 1 percent. At meet all other requirements of the ap- least 98 percent of the bone particles plicable standards of identity or com- present in ‘‘Mechanically Separated position. (Kind of Poultry) ‘‘ shall have a max- (5) Water and fat-replacers (e.g., bind- imum size no greater than 1.5 mm (mil- ers), in combination, may be added to limeter) in their greatest dimension replace fat in accordance with para- and there shall be no bone particles graph (c) of this section. larger than 2.0 mm in their greatest di- (6) Textured vegetable protein may mension. be used by itself or in combination (c) ‘‘Mechanically Separated (Kind of with other binders and water as a fat Poultry)’’ shall not have a calcium replacer in accordance with paragraph content exceeding 0.235 percent when (c) of this section. made from mature chickens or from (d) Nomenclature. The name of a sub- turkeys as defined in § 381.170(a)(l)(vi) stitute poultry product that complies and (vii) and (a)(2), respectively, or with this section is the appropriate ex- 0.175 percent when made from other pressed nutrient content claim and the poultry, based on the weight of product applicable standardized term. that has not been heat treated, as a (e) Label declaration. (1) Each of the measure of a bone solids content of not ingredients used in the substitute poul- more than 1 percent. try product shall be declared on the (d) ‘‘Mechanically Separated (Kind of label as required by this section and Poultry)’’ may be used in the formula- subpart N of this part. tion of poultry products in accordance (2) Ingredients not provided for, and with § 381.174 and meat food products in ingredients used in excess of those lev- accordance with subchapter A of this els provided for, by the standard as de- chapter. fined in subpart P of this part, shall be (e) Product resulting from the me- identified as such with an asterisk in chanical separation process that fails the ingredients statement. The state- to meet the bone particle size or cal- ment ‘‘*Ingredients not in regular cium content requirements for ‘‘Me- lllll’’ (the blank shall be filled in chanically Separated (Kind of Poul- with the name of the traditional stand- try)’’ shall be used only in producing

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poultry extractives, including fats, abled, or diseased poultry or parts of stocks, and broths and labeled as ‘‘Me- the carcasses of any poultry that died chanically Separated (Kind of Poultry) otherwise than by slaughter. for Further Processing.’’ (b) The required records are: (1) Records, such as bills of sale, in- [60 FR 55983, Nov. 3, 1995] voices, bills of lading, and receiving § 381.174 Limitations with respect to and shipping papers, giving the fol- use of Mechanically Separated lowing information with respect to (Kind of Poultry). each transaction in which any poultry (a) A poultry product required to be or poultry carcass, or part or product prepared from a particular kind of of a poultry carcass, is purchased, sold, poultry (e.g., chicken) shall not con- shipped, received, transported, or oth- tain ‘‘Mechanically Separated (Kind of erwise handled by said person in con- Poultry)’’ described in § 381.173, that is nection with any business subject to made from any other kind of poultry the Act. (e.g., Mechanically Separated Turkey). (i) The name or description of the (b) ‘‘Mechanically Separated (Kind of poultry or other articles; Poultry)’’ described in § 381.173 may be (ii) The net weight of the poultry or used in the formulation of any poultry other articles; or meat food product, provided such (iii) The number of outside con- use conforms with any applicable re- tainers; quirements of the definitions and (iv) The name and address of the standards of identity or composition in buyer of the poultry or other articles this subchapter or part 319 of this chap- sold by such person, and the name and ter, and provided that it is identified as address of the seller of the poultry or ‘‘Mechanically Separated (Kind of other articles purchased by such per- Poultry).’’ son; (v) The name and address of the con- [60 FR 55983, Nov. 3, 1995] signee or receiver (if other than the buyer); Subpart Q—Records, Registration, (vi) The method of shipment; and Reports (vii) The date of shipment; and (viii) The name and address of the § 381.175 Records required to be kept. carrier. (a) Every person within any of the (2) Guaranties provided by suppliers classes specified in paragraph (a) (1), of packaging materials under § 381.144. (2), or (3) of this section is required by (3) Records of canning as required by the Act to keep such records as are subpart X of this part 381, of sub- properly necessary for the effective en- chapter C, 9 CFR chapter III. forcement of the Act: (4) Records of irradiation as required (1) Any person that engages in the by sections 381.149 of this part. business of slaughtering any poultry or (5) Records of nutrition labeling as processing, freezing, packaging, or la- required by subpart Y of this part. beling any carcasses, or parts or prod- (6) Records of all labeling, along with ucts of carcasses, of any poultry, for the product formulation and processing commerce, for use as human food or procedures, as prescribed in §§ 381.132 animal food; and 381.133. (2) Any person that engages in the (Approved by the Office of Management and business of buying or selling (as a poul- Budget under control number 0583–0015) try products broker, wholesaler, or [37 FR 9706, May 16, 1972, as amended at 47 otherwise) or transporting, in com- FR 746, Jan. 7, 1982; 49 FR 2236, Jan. 19, 1984; merce, or storing in or for commerce, 51 FR 45633, Dec. 19, 1986; 57 FR 43600, Sept. or importing, any carcasses, or parts or 21, 1992; 58 FR 675, Jan. 6, 1993; 60 FR 67458, products of carcasses, of any poultry; Dec. 29, 1995] (3) Any person that engages in business, in or for commerce, as a renderer, § 381.176 Place of maintenance of or engages in the business of buying, records. selling, or transporting in commerce, Every person engaged in any business or importing, any dead, dying, dis- described in § 381.175(a) shall maintain

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the records required by § 381.175 at the the business as a public warehouseman place of business where such business is storing any such articles in or for com- conducted, except that, if such person merce, or engages in the business of conducts such business at multiple lo- buying, selling, or transporting in com- cations, he may maintain such records merce, or importing, any dead, dying, at his headquarters’ office. When not in disabled, or diseased poultry, or parts actual use, all such records shall be of the carcasses of any poultry that kept in a safe place at the prescribed died otherwise than by slaughter, shall location in accordance with good com- register with the Administrator, giving mercial practices. such information as is required, including his name, and the address of each § 381.177 Record retention period. place of business at which, and all (a) Every record required to be main- trade names under which he conducts tained under this subpart shall be re- such business. Such persons shall reg- tained for a period not to exceed 2 ister under this section by filing with years after December 31 of the year in the Administrator, Food Safety and In- which the transaction to which the spection Service, U.S. Department of record relates has occurred, and for Agriculture, Washington, DC 20250, a such further period as the Adminis- form containing such information, trator may require for purposes of any within 90 days after the effective date investigation or litigation under the hereof or after such later date as he be- Act, by written notice to the person required to keep such record under this gins to engage in such business if not subpart. engaged therein upon said effective (b) Records of canning as required by date. All information submitted shall subpart X of this part 381, subchapter be current and correct. The registra- C, 9 CFR chapter III, shall be retained tion form shall be obtained from Dis- as required in § 381.307; except that trict Enforcement Operations, Field records required by § 381.302 (b) and (c) Operations, Food Safety and Inspection shall be retained as required by those Service, U.S. Department of Agri- sections. culture, Washington, DC 20250 or by calling the District Office. [37 FR 9706, May 16, 1972, as amended at 51 (b) Whenever any change is made in FR 45633, Dec. 19, 1986] the name of, or address of any place of § 381.178 Access to and inspection of business at which, or any trade name records, facilities and inventory; under which a registrant conducts his copying and sampling. business, he shall report such change in Representatives of the Secretary af- writing to the Administrator within 15 forded access to a business specified in days after making the change. § 381.175 of this part (see § 300.6(b)(2) of (c) The registration requirements this chapter) also must be afforded any prescribed in this section shall not necessary facilities (other than repro- apply to persons conducting any of the duction equipment) for the examina- businesses specified in this section only tion and copying of records and the ex- at an official establishment. amination and sampling of inventory. [37 FR 9706, May 16, 1972, as amended at 39 [69 FR 255, Jan. 5, 2004] FR 4569, Feb. 5, 1974; 57 FR 53982, Nov. 16, 1992; 69 FR 255, Jan. 5, 2004] § 381.179 Registration. (a) Except as provided in paragraph § 381.180 Information and reports re- (c) of this section, every person that quired from official establishment operators. engages in business, in or for commerce, as a poultry products broker, (a) The operator of each official es- renderer, or animal food manufacturer, tablishment shall furnish to Program or engages in business in commerce as employees accurate information as to a wholesaler of any carcasses, or parts all matters needed by them for making or products of the carcasses, of any their daily reports of the amount of poultry, whether intended for human products prepared or handled in the de- food or other purposes, or engages in partments of the establishment to

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which they are assigned and such re- Subpart R—Cooperation With ports concerning sanitation, manda- States and Territories; Certifi- tory microbiological testing, and other cation of State and Territorial aspects of the operations of the estab- Programs as at Least Equal to lishment and the conduct of inspection Federal Program thereat, as may be required by the Ad- ministrator in special cases. § 381.185 Assistance to State and Terri- (b) The operator of each official es- torial programs. tablishment shall also make such other (a) The Administrator is authorized, reports as the Administrator may from under paragraph (a) of section 5 of the time to time require under the Act. Act, when he determines it would effectuate the purposes of the Act, to co- [37 FR 9706, May 16, 1972, as amended at 61 operate with any State (including FR 38868, July 25, 1996] Puerto Rico) or any organized territory § 381.181 Reports by consignees of al- in developing and administering the legedly adulterated or misbranded poultry product inspection program of products; sale or transportation as such jurisdiction, with a view to assur- violations. ing that it imposes and enforces requirements at least equal to those Whenever the consignee of any poul- under sections 2 through 4, 6 through try product which bears an official in- 10, and 12 through 22 of the Act, with spection legend refuses to accept deliv- respect to establishments at which ery of such product on the grounds that poultry are slaughtered or poultry it is adulterated or misbranded, the products are processed for use as consignee shall notify the appropriate human food, solely for distribution program supervisor, Meat and Poultry within such jurisdiction, and with re- Inspection Program, Food Safety and spect to the poultry products of such Inspection Service, U.S. Department of establishments. Such cooperation is Agriculture, of the kind, quantity, authorized if the jurisdiction has en- source and present location of the acted a mandatory law imposing ante product and the respects in which it is mortem and post mortem inspection, alleged to be adulterated or mis- reinspection, and sanitation require- branded, and it will be a violation of ments (at least equal to those under the Act for any person to sell or trans- the Federal Act), with respect to all or port, or offer for sale or transportation certain classes of persons engaged in slaughtering poultry or otherwise proc- or receive for transportation, in com- essing poultry products for use as merce, any such product which is capa- human food solely for distribution ble of use as human food and is in fact within such jurisdiction. adulterated or misbranded at the time (b) The Administrator is also author- of such sale, transportation, offer, or ized under paragraph (a) of section 5 of receipt: Provided, That any such alleg- the Act, to cooperate with any State edly adulterated or misbranded product (including Puerto Rico) or any orga- may be transported to any official es- nized territory in developing and ad- tablishment for reinspection. ministering programs under the laws of such jurisdiction containing authori- § 381.182 Reports of inspection work. ties at least equal to those provided in Reports of the inspection work car- section 11 of the Act (relating to ried on within official establishments records; registration of specified class- shall be forwarded to the Adminis- es of operators; dead, dying, disabled, or diseased poultry; and products not trator by the inspector in charge in intended for human food) when he de- such a manner as may be specified by termines that such cooperation would the Administrator. effectuate the purposes of the Act. (c) Such cooperation may include advisory assistance, technical and laboratory assistance and training, and financial aid. The Federal contribution to any State (or territory) for any year

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shall not exceed 50 percent of the esti- who will be an FSIS employee, to each mated total cost of the cooperative State that participates in a coopera- State (or territorial) program. A coop- tive interstate shipment program to erative program under this section is provide Federal oversight of the pro- called a State-Federal program. gram and enforcement of the program’s requirements. The Federal contribu- § 381.186 Cooperation of States and tion for inspection services provided by other jurisdictions in Federal pro- States that enter into a cooperative grams. interstate shipment program under Under the ‘‘Talmadge-Aiken Act’’ of this section will be at least 60 percent September 28, 1962 (7 U.S.C. 450), the of eligible State costs. Eligible State Administrator is authorized under costs are those costs that a State has stated conditions to utilize employees justified and FSIS has approved as nec- and facilities of any State in carrying essary for the State to provide inspec- out Federal functions under the Poul- tion services to selected establish- try Products Inspection Act. A cooper- ments in the State. ative program for this purpose is called (c) Subpart Z, of this part 381 pre- a Federal-State program. Under para- scribes conditions under which States graph (a) of section 5 of the Poultry and establishments may participate in Products Inspection Act, the Adminis- the cooperative interstate shipment trator is also authorized to conduct ex- program. aminations, investigations, and inspec- (d) The Administrator will terminate tions under the Act through any officer a cooperative interstate shipment or employee of any State or territory agreement with a State if the Adminis- or the District of Columbia commis- trator determines that the State is not sioned by him for such purpose. conducting inspection at selected establishments in a manner that com- § 381.187 Cooperation of States for the plies with the Act and the imple- interstate shipment of poultry prod- menting regulations in this chapter. ucts. [76 FR 24756, May 2, 2011] (a) The Administrator is authorized under 21 U.S.C. 472(b) to coordinate Subpart S—Transportation; Expor- with States that have poultry products tation; or Sale of Poultry or inspection programs as provided in § 381.185 of this subpart to select cer- Poultry Products tain establishments operating under § 381.189 Provisions inapplicable to these programs to participate in a co- specimens for laboratory examina- operative program to ship poultry tion, etc., or to naturally inedible products in interstate commerce. A co- articles. operative program for this purpose is The provisions of this subpart do not called a ‘‘cooperative interstate ship- apply: ment program.’’ (a) To dead, dying, disabled or dis- (b) Establishments selected to par- eased poultry and specimens of ticipate in a cooperative interstate undenatured, uninspected or adulter- shipment program described in this ated carcasses, parts, or products of section must receive inspection serv- poultry sent to or by the Department ices from designated State personnel of Agriculture or divisions thereof in that have been trained in the enforce- Washington, DC, or elsewhere, for lab- ment of the Act. If the designated per- oratory examination, exhibition pur- sonnel determine that the poultry poses, or other official use; products prepared in establishments se- (b) To dead, dying, disabled or dis- lected to participate in the cooperative eased poultry and specimens of interstate shipment program comply undenatured, uninspected or adulter- with all requirements under the Act, ated carcasses, parts, or products of these items will bear an official Fed- poultry thereof for educational, re- eral mark of inspection and may be search, or other nonfood purposes shipped in interstate commerce. The shipped under permit issued by the in- Administrator will assign an FSIS spector in charge upon his determina- ‘‘selected establishment coordinator,’’ tion that collection and movement

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thereof will not interfere with inspec- tablishment in an acceptable manner tion or sanitary conditions at the es- may be shipped from the official estab- tablishment, and the specimens are for lishment directly for export as human nonfood purposes. The person desiring food, if they have been examined and such specimens shall make a written found to be suitable for such purpose, application to the inspector in charge by an inspector and are labeled as pre- for such permit on Form MP–112 and scribed in this paragraph. shall obtain permission from the oper- (ii) The containers of all such prod- ator of the official establishment to ob- ucts shall bear a label showing: (A) The tain the specimens. Permits shall be name of the products; (B) the name and issued for a period not longer than one address of the packer or distributor, year. The permit may be revoked by and, when the name of the distributor the inspector in charge if he deter- is shown, it shall be qualified by such mines after notice and opportunity to terms as ‘‘packed for,’’ ‘‘distributed present views is afforded to the per- by,’’ or ‘‘distributors’’; and (C) the offi- mittee that any such specimens were cial establishment number of the es- not used as stated in the application, tablishment where packed. or if the collection or handling of the (iii) Such products shall not bear the specimens interferes with inspection or official inspection legend. the maintenance of sanitary conditions (3)(i) Poultry heads and feet that are in the establishment. The specimens collected and handled at an official es- referred to in this paragraph shall be tablishment in an acceptable manner collected and handled only at such may be shipped from the official estab- time and place and in such manner as lishment and in commerce directly to not to interfere with the inspection or another official establishment for proc- to cause any objectionable condition essing before export, provided the re- and shall be identified as inedible when ceiving establishment maintains they leave the establishment. records that: (c) To parts of poultry carcasses that (A) Identify the source of the incom- are naturally inedible by humans, such ing undenatured poultry product; as entrails and feathers in their nat- (B) Identify the location of the prod- ural state. uct at all times during processing and [40 FR 55310, Nov. 28, 1975] preparation for export; and (C) Contain a written certification § 381.190 Transactions in slaughtered from an official of the receiving estab- poultry and other poultry products lishment that the undenatured poultry restricted; vehicle sanitation re- product intended for export has not quirements. been, and will not be, commingled with (a) No person shall sell, transport, any product intended for consumption offer for sale or transportation, or rein the United States. ceive for transportation, in commerce (ii) The receiving establishment may or from any official establishment, any only ship the undenatured poultry slaughtered poultry from which the product intended for export in accord- blood, feathers, feet, head, or viscera ance with the inspection and labeling have not been removed in accordance requirements of paragraph (b)(2) of this with the regulations. section. (b)(1) No person shall sell, transport, (c) No person, engaged in the busi- offer for sale or transportation, or re- ness of buying, selling, freezing, stor- ceive for transportation, in commerce, ing, or transporting, in or for com- any slaughtered poultry or other poul- merce, poultry products capable of use try product which is capable of use as as human food, or importing such arti- human food and is adulterated or fails cles, shall transport, offer for transpor- to bear an official inspection legend or tation, or receive for transportation, in is otherwise misbranded at the time of commerce or in any State designated such sale, transportation, offer or re- under § 381.221, any poultry product ceipt, except as otherwise provided in which is capable of use as human food this paragraph (b) and subpart C or T. and is not wrapped, packaged, or other- (2)(i) Poultry heads and feet that are wise enclosed to prevent adulteration collected and handled at an official es- by airborne contaminants, unless the

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railroad car, truck, or other means of tors or jobbers may remove inspected conveyance in which the product is and passed non-consumer-packaged contained or transported is completely poultry carcasses or consumer-pack- enclosed with tight fitting doors or aged poultry products from shipping other covers for all openings. In all containers or immediate containers, cases, the means of conveyance shall be other than consumer packages, and reasonably free of foreign matter (such place them into other containers which as dust, dirt, rust, or other articles or do not bear an official inspection mark: residues), and free of chemical resi- Provided, That the individual non-con- dues, so that product placed therein sumer-packaged carcasses bear the of- will not become adulterated. Any ficial inspection legend and the official cleaning compound, lye, soda solution, establishment number of the establish- or other chemical used in cleaning the ment that processed the articles; and means of conveyance must be thor- the consumer-packaged articles are oughly removed from the means of con- fully labeled in accordance with sub- veyance prior to its use. Such means of part N: And provided further, That the conveyance onto which product is load- other container is marked with the ed, being loaded, or intended to be name and address of the distributor or loaded, shall be subject to inspection jobber and bears the statement ‘‘The by an inspector at any official estab- poultry product contained herein was lishment. The decision whether or not inspected by the U.S.D.A.’’ in the case to inspect a means of conveyance in a of poultry products processed in the specific case, and the type and extent United States, or the statement ‘‘The of such inspection shall be at the In- poultry products contained herein have spection Service’s discretion and shall been approved for importation under be adequate to determine if poultry P.P.I.A.’’ in the case of imported poul- product in such conveyance is, or when try products. moved could become, adulterated. Circumstances of transport that can be § 381.192 Penalties inapplicable to car- reasonably anticipated shall be consid- riers. ered in making said determination. No carrier shall be subject to the These include, but are not limited to, penalties of the Act, other than the weather conditions, duration and dis- penalties for violation of section 11, by tance of trip, nature of product cov- reason of his receipt, carriage, holding, ering, and effect of restowage at stops or delivery, in the usual course of busi- en route. Any means of conveyance ness, as a carrier, of poultry or poultry found upon such inspection to be in products, owned by another person, un- such condition that poultry product less the carrier has knowledge, or is in placed therein could become adulter- possession of facts which would cause a ated shall not be used until such condi- reasonable person to believe that such tion which could cause adulteration is poultry or poultry products were not corrected. Poultry product placed in inspected or marked in accordance any means of conveyance that is found with the provisions of the Act or where by the inspector to be in such condi- otherwise not eligible for transpor- tion that the poultry product may have tation under the Act, or unless the car- become adulterated shall be removed rier refuses to furnish on request of a from the means of conveyance and han- representative of the Secretary, the dled in accordance with § 381.145(b). name and address of the person from [37 FR 9706, May 16, 1972, as amended at 39 whom he received such poultry or poul- FR 4569, Feb. 5, 1974; 40 FR 42338, Sept. 12, try products, and copies of all docu- 1975; 41 FR 23700, June 11, 1976; 60 FR 43358, ments, if any there be, pertaining to Aug. 21, 1995] the delivery of the poultry or poultry products to such carrier. § 381.191 Distribution of inspected products to small lot buyers. § 381.193 Poultry carcasses, etc., not For the purpose of facilitating the intended for human food. distribution in commerce of inspected (a) Except as provided in paragraph poultry products to small lot buyers (b) of this section, poultry carcasses, (such as small restaurants), distribu- and parts and products thereof, that

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are not intended for use as human food the article, wherever it appears on the may, after they have been denatured as label, must be stated in letters at least prescribed in § 381.95, be bought, sold, twice as high, wide, and thick as the transported, offered for sale or trans- letters indicating the presence in the portation, or received for transpor- article of any ingredients derived from tation, in commerce, or imported, even carcasses of poultry. though they do not comply with all the (ii) Notwithstanding the provisions of provisions of the regulations, provided paragraph (i) of paragraph (b)(3) of this they are marked ‘‘Not fit for human section, the article’s name may be food.’’ These requirements do not apply stated on the label to show that it is or to parts of poultry carcasses that are contains poultry carcass-source mate- naturally inedible by humans, such as rial and that the article is for animals; entrails. (b)(1) Except as provided in para- e.g., ‘‘Chicken for Pets’’ or ‘‘Turkey graphs (b) (2), (3), and (4) of this sec- Dinner for Cats’’: Provided, That the tion, no animal food processed, in entire name of the article is stated, whole or in part, from materials de- wherever it appears on the label, as an rived from the carcasses of poultry in individual, contiguous unit, whether an official establishment or elsewhere, stated on a single line or more than shall be bought, sold, transported, of- one line, and the letters denoting the fered for sale or transportation, or re- article’s intended use for animal food ceived for transportation in commerce, are at least as high, wide, and thick as or imported, unless: the letters indicating the presence of (i) It is properly identified as animal material derived from any poultry car- food; cass. However, when the label bears on (ii) It is not represented as being a its principal display panel a vignette human food; and which pictures, in clearly recognizable (iii) It has been denatured as pre- form and size, one or more animals of scribed in § 381.95 so as to be readily the species for which the article’s name distinguishable from an article of indicates the article is intended, the human food. letters used to state the article’s in- (2) Notwithstanding the provisions of tended use shall be at least one-half as paragraph (b)(1) of this section, an ani- high, wide, and thick as the letters mal food that consists of less than 5 used in the article’s name or other let- percent of parts or products of the car- ters indicating the presence of mate- casses of poultry and that is not rep- rial derived from any poultry carcass, resented by labeling or appearance or 1 otherwise as being a human food or as but shall not be less than ⁄8 inch high. a product of the poultry industry need The letters used to state the article’s not be denatured in accordance with intended use may be separated from § 381.95. the article’s name by the vignette. (3) Notwithstanding the provisions of (iii) Letters used to denote the in- paragraph (b)(1) of this section, animal tended use of the article must contrast food packed in hermetically sealed, reas markedly with their background as tort processed, conventional retail-size the letters indicating the presence in containers, and retail-size packages of the article of poultry carcass-source semi-moist animal food need not be de- material contrast with their back- natured in accordance with § 381.95 if ground. the name of the article clearly conveys (4) The requirements of this part do the article’s intended use for animal not apply to livestock or poultry feed food and appears on the label in a con- manufactured from processed poultry spicuous manner. byproducts (such as poultry byproduct (i) Except as provided in paragraph meal, hydrolyzed poultry feathers, and (ii) of paragraph (b)(3) of this section, hydrolyzed poultry byproducts aggre- the name of the article must be stated gate), or to processed dry animal food. on the label as ‘‘Animal Food,’’ ‘‘Pet Food,’’ or ‘‘(name of species) Food’’ [49 FR 47479, Dec. 5, 1984] (e.g., ‘‘Dog Food’’ or ‘‘Cat Food’’). To be considered conspicuous, the name of

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§ 381.194 Transportation and other into another means of conveyance; but transactions concerning dead, in all such cases, the carrier shall im- dying, disabled, or diseased poultry, mediately report the facts by telegraph and parts of carcasses of poultry or telephone to the Director, Compli- that died otherwise than by slaugh- ance Staff, Meat and Poultry Inspec- ter. tion Program, Food Safety and Inspec- No person engaged in the business of tion Service, U.S. Department of Agri- buying, selling, or transporting in com- culture, Washington, DC 20250. merce, or importing any dead, dying, disabled, or diseased poultry or parts of [40 FR 55310, Nov. 28, 1975] the carcasses of any poultry that died otherwise than by slaughter shall: Subpart T—Imported Poultry (a) Sell, transport, offer for sale or Products transportation or receive for transportation, in commerce, any dead, dying, § 381.195 Definitions; requirements for disabled, or diseased poultry, or parts importation into the United States. of the carcasses of any poultry that (a) When used in this part, the fol- died otherwise than by slaughter, un- lowing terms shall be construed to less such poultry and parts are con- mean: signed and delivered, without avoidable delay, to establishments of animal food (1) Import (Imported). To bring within manufacturers, renderers, or collection the territorial limits of the United stations that are registered as required States whether that arrival is accom- by § 381.179, or to official establish- plished by land, air, or water. ments that operate under Federal in- (2) For product from eligible coun- spection, or to establishments that op- tries other than Canada: erate under a State or Territorial in- (i) Offer(ed) for entry. The point at spection system approved by the Sec- which the importer presents the im- retary as one that imposes require- ported product to the Program for rein- ments at least equal to the Federal re- spection. quirements for purposes of section 5(c) (ii) Entry (entered). The point at of the Act. which imported product offered for (b) Buy in commerce or import any entry receives reinspection and is dead, dying, disabled, or diseased poul- marked with the official mark of in- try or parts of the carcasses of any spection in accordance with § 327.26 of poultry that died otherwise than by this part. slaughter, unless he is an animal food (3) For product from Canada: manufacturer or renderer and is reg- (i) Offer(ed) for entry from establish- istered as required by § 381.179, or is the ments participating in the ‘‘stream- operator of an establishment inspected lined’’ inspection procedures. The point as required by paragraph (a) of this sec- at which an official of the Canadian in- tion and such poultry or parts of car- spection system contacts the Import casses are to be delivered to establishments eligible to receive them under Field Office for an inspection assign- paragraph (a) of this section. ment. (c) Unload en route to any establish- (ii) Offer(ed) for entry from non- ment eligible to receive them under participating establishments. The paragraph (a) of this section, any dead, point at which the importer presents dying, disabled, or diseased poultry or the imported product to the Program parts of the carcasses of any poultry for reinspection. that died otherwise than by slaughter, (iii) Entry (entered) for product not which are transported in commerce or subject to reinspection. When the con- imported by any such person: Provided, tainers or the products themselves if That any such dead, dying, disabled, or not in containers are marked with the diseased poultry, or parts of carcasses Canadian export stamp and upon the may be unloaded from a means of con- filing of Customs Form 7533 at the port veyance en route where necessary in of entry or at the nearest customs- case of a wreck or otherwise extraor- house in accordance with 19 CFR part dinary emergency, and may be reloaded 123.

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(iv) Entry (entered) for product sub- ance with paragraph (a)(3) of this sec- ject to reinspection. When the con- tion shall be eligible, so far as the reg- tainers or the products themselves if ulations in this part are concerned, for not in containers are marked with the importation into the United States Canadian export stamp and the foreign from such foreign country after appli- inspection certificate accompanying cable requirements of this part have the product is stamped as ‘‘Inspected been met. and Passed’’ by the import inspector. (2) The determination of accept- (b) No slaughtered poultry, or parts ability of a foreign poultry inspection or products thereof, shall be imported system for purposes of this section into the United States unless they are shall be based on an evaluation of the healthful, wholesome, fit for human foreign program in accordance with the food, not adulterated, and contain no following requirements and procedures: dye, chemical, preservative, or ingre- (i) The system shall have a program dient which renders them unhealthful, organized and administered by the na- unwholesome, adulterated, or unfit for tional government of the foreign coun- human food and they also comply with try. The system as implemented must the regulations prescribed in this sub- provide standards equivalent to those part to assure that they comply with of the Federal system of poultry in- the standards provided for in the Act: spection in the United States with re- Provided, That the provisions of this spect to: subpart apply to such articles only if (A) Organizational structure and they are capable of use as human food. staffing, so as to insure uniform en- (c) Except as provided in § 381.207, forcement of the requisite laws and slaughtered poultry and other poultry regulations in all establishments products may be imported only if they throughout the system at which poul- were processed solely in countries list- try products are processed for export to ed in § 381.196(b). Slaughtered poultry the United States; may be imported only if it qualifies as (B) Ultimate control and supervision ready-to-cook poultry. by the national government over the [37 FR 9706, May 16, 1972, as amended at 40 official activities of all employees or FR 42338, Sept. 12, 1975; 54 FR 41049, Oct. 5, licensees of the system; 1989] (C) The assignment of competent, qualified inspectors; § 381.196 Eligibility of foreign coun- (D) Authority and responsibility of tries for importation of poultry national inspection officials to enforce products into the United States. the requisite laws and regulations gov- (a)(1) Whenever it shall be deter- erning poultry inspection and to cer- mined by the Administrator that the tify or refuse to certify poultry prod- system of poultry inspection main- ucts intended for export; tained by any foreign country, with re- (E) Adequate administrative and spect to establishments preparing prod- technical support; ucts in such country for export to the (F) The inspection, sanitation, qual- United States, insures compliance of ity, species verification, and residue such establishments and their poultry standards applied to products produced products, with requirements equivalent in the United States. to all the provisions of the Act and the (G) Other requirements of adequate regulations in this part which are ap- inspection service as required by the plied to official establishments in the regulations. United States, and their poultry prod- (ii) The legal authority for the sys- ucts, and that reliance can be placed tem and the regulations thereunder upon certificates required under this shall impose requirements equivalent subpart from authorities of such for- to those governing the system of poul- eign country, notice of that fact will be try inspection organized and main- given by including the name of such tained in the United States with re- foreign country in paragraph (b) of this spect to: section. Thereafter, poultry products (A) Ante mortem inspection of poul- processed in such establishments which try for slaughter, which shall be per- are certified and approved in accord- formed by veterinarians or by other

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employees or licensees of the system country for importation of poultry under the direct supervision of veteri- products into the United States de- narians; pends on the results of periodic reviews (B) Post mortem inspection of car- of the foreign poultry inspection sys- casses and parts thereof at time of tem in operation by a representative of slaughter, performed by veterinarians the Department, and the timely sub- or other employees or licensees of the mission of such documents and other system under the direct supervision of information related to the conduct of veterinarians; the foreign inspection system as the (C) Official controls by the national Administrator may find pertinent to government over establishment con- and necessary for the determinations struction, facilities, and equipment; required by this section. (D) Direct and continuous official su- (iv) The foreign inspection system pervision of slaughtering of poultry must maintain a program to assure and processing of poultry products, by that the requirements referred to in the assignment of inspectors to establishments certified under paragraph this section, equivalent to those appli- (a)(3) of this section to assure that cable to the Federal system in the adulterated or misbranded poultry United States, are being met. The pro- products are not processed for export gram as implemented must provide for to the United States; the following: (E) Complete separation of establish- (A) Periodic supervisory visits by a ments certified under subparagraph (3) representative of the foreign inspection of this paragraph from establishments system to each establishment certified not certified, and the maintenance of a in accordance with paragraph (a)(3) of single standard of inspection and sani- this section to ensure that require- tation throughout all certified estab- ments referred to in paragraphs lishments; (a)(2)(ii)(A) through (H) of this section (F) Requirements for sanitation at are being met: Provided, That such vis- certified establishments and for sani- its are not required with respect to any tary handling of poultry products; establishment during a period when the (G) Official controls over condemned establishment is not operating or is material until destroyed or removed not engaged in producing products for and thereafter excluded from the estab- exportation to the United States; lishment; (B) Written reports prepared by the (H) A Hazard Analysis and Critical representative of the foreign inspection Control Point (HACCP) system, as set system who has conducted a super- forth in part 417 of this chapter. visory visit, documenting his or her (I) Other matters for which require- findings with respect to the requirements are contained in the Act or the ments referred to in paragraphs regulations in this part. (a)(2)(ii)(A) through (a)(2)(ii)(H) of this (iii) Countries desiring to establish section, copies of which shall be made eligibility for importation of poultry available to the representative of the products into the United States may request a determination of eligibility Department at the time of the rep- by presenting copies of the laws and resentative’s review upon request by regulations on which the foreign poul- that representative to a responsible try inspection system is based and such foreign inspection official: Provided, other information as the Adminis- that such reports are not required dur- trator may require with respect to ing a period when the establishment is matters enumerated in paragraphs not operating or not engaged in pro- (a)(2) (i) and (ii). Determination of eli- ducing products for exportation to the gibility is based on a study of the docu- United States. ments and other information presented (C) Random sampling and testing at and an initial review of the system in the point of slaughter of carcasses, in- operation by a representative of the cluding internal organs and fat, for res- Department using the criteria listed in idues identified by the exporting coun- paragraphs (a)(2) (i) and (ii) of this sec- try’s inspection authorities or by this tion. Maintenance of eligibility of a Agency as potential contaminants, in

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accordance with sampling and analyt- Control numbers Name ical techniques approved by the Admin- Address istrator: Provided, that such testing is llllllllllllllllllllllll required only on samples taken of car- llllllllllllllllllllllll casses from which poultry or poultry llllllllllllllllllllllll products intended for importation into Datellllll. the United States are produced. llllllllllllll (3) Only those establishments that (Signature) are determined and certified to the De- llllllllllllll partment by a responsible official of (Official title) the foreign poultry inspection system (4) Poultry products from foreign as fully meeting the requirements of countries not listed in paragraph (b) of paragraphs (a)(2) (i) and (ii) of this sec- this section are not eligible for impor- tion are eligible to have their products tation into the United States, except imported into the United States. Eligi- as provided by §§ 381.207 and 381.209. The bility of certified establishments is listing of any foreign country under subject to review by the Department this section may be withdrawn when- (including observations of the estab- ever it shall be determined by the Ad- lishments by Program representatives ministrator that the system of poultry at times prearranged with the officials inspection maintained by such foreign of the foreign inspection system). Cer- country does not assure compliance tifications of establishments must be with requirements equivalent to all the renewed annually. Notwithstanding requirements of the Act and the regu- certification by a foreign official, the lations as applied to official establish- Administrator may, at his discretion, ments in the United States; or that re- terminate the eligibility of any foreign liance cannot be placed upon certifi- establishment for importation of its cates required under this subpart from poultry products into the United authorities of such foreign country; or States if he has information that such that, for lack of current information establishment does not comply with concerning the system of poultry in- the requirements listed in paragraphs spection being maintained by such for- (a)(2) (i) and (ii) of this section or if he eign country, such foreign country cannot obtain current information con- should be required to reestablish its cerning such establishment. The Ad- eligibility for listing. ministrator will provide reasonable no- (b) It has been determined that poul- tice to the foreign government of the try products from the following coun- proposed termination of eligibility of tries, covered by foreign poultry in- any foreign establishment for importa- spection certificates of the country of tion of its poultry products into the origin as required by § 381.197, are eligi- United States unless, in his judgment, ble under the regulations in this sub- delay in terminating its eligibility part for entry into the United States, could result in the importation of any after inspection and marking as re- adulterated or misbranded poultry quired by the applicable provisions of products. Certifications of official es- this subpart: 1 tablishments by the responsible official of the foreign poultry inspection sys- Australia (ratites only). tem shall be in the following form: Canada. Chile. FOREIGN OFFICIAL POULTRY ESTABLISHMENT France. CERTIFICATE Great Britain. Hong Kong. I hereby certify that the establishment(s) Israel. listed below fully complies (comply) with re- Mexico. 2 quirements of (specify foreign country) equivalent to all the provisions of the Poul- try Products Inspection Act and regulations 1 Listing of any country in this section issued thereunder, which apply to official es- does not relieve the poultry products of such tablishments in the United States, and their country from applicable requirements under poultry products, as provided in other Federal laws. § 381.196(a)(2)(i) and (ii) of the poultry prod- 2 May export to the United States only ucts inspection regulations of the United processed poultry products slaughtered States. under Federal inspection in the United

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New Zealand (ratites only). llllllllllllllllllllllll People’s Republic of China. 2 llllllllllllllllllllllll Identification marks on containers [37 FR 9706, May 16, 1972, as amended at 43 lllll FR 8117, Feb. 28, 1978; 52 FR 23021, June 17, Consignor llllllllllllllllll 1987; 54 FR 41049, Oct. 5, 1989; 54 FR 43951, Address lllllllllllllllllll Oct. 30, 1989; 60 FR 38668, July 28, 1995; 61 FR Consignee llllllllllllllllll 38868, July 25, 1996; 64 FR 49645, Sept. 14, 1999; Destination lllllllllllllllll 68 FR 37071, June 23, 2003; 71 FR 20871, Apr. Shipping marks lllllllllllllll 24, 2006; 71 FR 43961, Aug. 3, 2006; 72 FR 61796, (Signature) llllllllllllll Nov. 1, 2007] (Name of official of national foreign government authorized to issue inspection certifi- § 381.197 Imported products; foreign cates for poultry products exported to the inspection certificates required. United States) (a) Except as provided in §§ 381.207 (Official title) lllllllllllll and 381.209, each consignment con- [37 FR 9706, May 16, 1972, as amended at 40 taining any slaughtered poultry or FR 42338, Sept. 12, 1975] other poultry product consigned to the United States from a foreign country § 381.198 Importer to make application shall be accompanied with a foreign infor inspection of poultry products spection certificate substantially in offered for entry. the form illustrated in paragraph (b) of (a) Each person who wishes to offer this section. for entry any slaughtered poultry or (b) The form of foreign poultry prod- other poultry product shall make ap- uct inspection certificate shall be as plication for inspection to the import follows: supervisor of the import field office at the port where the poultry product is FOREIGN POULTRY PRODUCT INSPECTION to be offered for entry, or to the Ad- CERTIFICATE ministrator, Food Safety and Inspec- Place llllllllllllllllllll tion Service, U.S. Department of Agri- (City) culture, Washington, DC 20250, as long llllllllllllll (Country) as possible in advance of the antici- Date lllllllllllllllllllll pated arrival of each consignment of such product, except in the case of I hereby certify that the poultry products poultry product exempted from inspec- herein described were derived from poultry which received ante mortem and post tion by §§ 381.207 or 381.209. Each appli- mortem inspections at the time of slaughter; cation shall state the approximate date and that such poultry products are sound, on which the consignment is due to ar- healthful, wholesome, clean and otherwise rive in the United States, the name of fit for human food, and are not adulterated the ship or other carrier transporting and have not been treated with and do not it, the name of the country where the contain any dye, chemical, preservative, or product was processed, the name of the ingredient not permitted by the regulations country from which the product was governing the inspection of poultry and poultry products of the U.S. Department of Agri- shipped, the place of destination, the culture, filed with me, and that said poultry quantity and kind of product, whether products have been handled only in a sani- fresh, frozen, cured, or canned, and the tary manner in this country; and are other- point of first arrival in the United wise in compliance with requirements at States. least equal to those in the Poultry Products (b) For participating Canadian estab- Inspection Act and said regulations. lishments, an official of the Canadian KIND OF PRODUCT meat inspection system shall contact the Import Field Office for an inspec- llllllllllllllllllllllll llllllllllllllllllllllll tion assignment (see § 301.2(yyy)). llllllllllllllllllllllll (1) If the Automated Import Informa- tion System (AIIS) does not designate Number of pieces or packages Weight the consignment for reinspection, the llllllllllllllllllllllll consignment may be transported to its consignee for further distribution. States or in a country eligible to export (2) If the AIIS designates the consign- slaughtered poultry products to the United ment for reinspection, the official States. shall:

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(i) Select samples in accordance with (d) In addition to the provisions spec- USDA sampling tables. ified in paragraphs (a), (b), and (c) of (ii) Identify and place samples in the this section, the following require- vehicle for easy removal and reinspec- ments apply to imported canned prod- tion by a Program import inspector. uct. (3) In the event that any one of the (1) Imported canned products are re- requirements provided in paragraph quired to be sound, healthful, properly (d)(2) of this section is not met, inspec- labeled, wholesome, and otherwise not tion of the consignment shall be con- adulterated at the time the products duced by a Program import inspector are offered for importation into the in accordance with established proce- United States. Provided other require- dures provided for in the regulations ments of this part are met, the deter- for other imported products. mination of the acceptability of the [37 FR 9706, May 16, 1972, as amended at 39 product and the condition of the con- FR 4569, Feb. 5, 1974; 51 FR 37710, Oct. 24, 1986; tainers shall be based on the results of 54 FR 275, Jan. 5, 1989; 54 FR 41050, Oct. 5, an examination of a statistical sample 1989] drawn from the consignment as provided in paragraph (a) of this section. If § 381.199 Inspection of poultry prod- the inspector determines, on the basis ucts offered for entry. of the sample examination, that the (a)(1) Except as provided in product does not meet the require- §§ 381.198(b)(1) and 381.209 of this part, ments of the Act and regulations there- and paragraph (c) of this section, all under, the consignment shall be re- slaughtered poultry and poultry prod- fused entry. However, a consignment ucts offered for entry from any foreign rejected for container defects but oth- country shall be reinspected by a Pro- erwise acceptable may be reoffered for gram import inspector before they inspection under the following condi- shall be allowed entry into the United tions: States. (i) If the defective containers are not (2) Every lot of product shall rou- indicative of an unsafe or unstable tinely be given visual inspection for product as determined by the Adminis- appearance and condition, and checked trator; for certification and label compliance, except as provided in § 381.198(b)(1). (ii) If the number and kinds of con- (3) The computerized Automated Im- tainer defects found in the original port Information System (AIIS) shall sample do not exceed the limits speci- be consulted for reinspection instruc- fied for this purpose in FSIS guide- tions. The AIIS will assign inspection lines; and levels and procedures based on estab- (iii) If the defective containers in the lished sampling plans or established consignment have been sorted out and product and plant history and estab- exported or destroyed under the super- lished sampling plans. vision of an inspector. (b) Inspectors may take, without cost (2) Representative samples of canned to the United States, from each con- product designated by the Adminis- signment of poultry products offered trator in instructions to inspectors for entry, such samples of the products shall be incubated under the super- as are deemed necessary to determine vision of such inspectors in accordance the eligibility of the products for entry with § 381.309 (d)(1)(ii), (d)(1)(iii), into the commerce of the United (d)(1)(iv)(c), (d)(1)(v), (d)(1)(vii), and States. (d)(1)(viii) of this subchapter. The im- (c) Poultry products imported under porter or his/her agent shall provide § 381.207 shall not be sampled and in- the necessary incubation facilities in spected under this section unless there accordance with § 381.309(d)(1)(i) of this is reason for suspecting the presence subchapter. therein of a substance in violation of (3) Sampling plans and acceptance that section, and in such case they levels as prescribed in paragraphs (d)(1) shall be sampled and inspected in ac- and (d)(2) of this section may be ob- cordance with paragraph (a) of this sec- tained, upon request, from Inter- tion. national Programs, Food Safety and

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Inspection Service, U.S. Department of States, shall be maintained in a sani- Agriculture, Washington, DC 20250. tary condition.

[37 FR 9706, May 16, 1972, as amended at 49 § 381.202 Poultry products offered for FR 36819, Sept. 20, 1984; 51 FR 45633, Dec. 19, 1986; 54 FR 275, Jan. 5, 1989; 54 FR 41050, Oct. entry; reporting of findings to cus- 5, 1989] toms; handling of articles refused entry; appeals, how made; denatur- § 381.200 Poultry products offered for ing procedures. entry, retention in customs custody; (a)(1) Program inspectors shall report delivery under bond; movement their findings as to any product which prior to inspection; handling; facilities and assistance. has been inspected in accordance with this part, to the Director of Customs at (a) No slaughtered poultry or other the original port of entry. poultry product required by this sub- (2) When product has been identified part to be inspected shall be released as ‘‘U.S. refused entry,’’ the inspector from customs custody prior to inspec- shall request the Director of Customs tion, but such product may be delivered to the consignee, or his agent, to refuse admission to such product prior to inspection, if the consignee and to direct that it be exported by the shall furnish a bond, in form prescribed owner or consignee within the time by the Secretary of the Treasury, con- specified in this section, unless the ditioned that the product shall be re- owner or consignee, within the speci- turned, if demanded, to the collector of fied time, causes it to be destroyed by the port where the same is offered for disposing of it under the supervision of clearance through the customs. a Program employee so that the prod- (b) Except as provided in paragraph uct can no longer be used as human (a) of this section, no product required food, or by converting it to animal food by this subpart to be inspected shall be uses, if permitted by the Food and moved, prior to inspection, from the Drug Administration. The owner or port of arrival where first unloaded, consignee of the refused entry product and if arriving by water, from the shall not transfer legal title to such wharf where first unloaded at such product, except to a foreign consignee port, to any place other than the place for direct and immediate exportation, designated in accordance with this sub- or an end user, e.g., an animal food part as the place where the same shall manufacturer or a renderer, for de- be inspected; and no product shall be struction for human food purposes. conveyed in any manner other than in ‘‘Refused entry’’ product must be deliv- compliance with this subpart. ered to and used by the manufacturer (c) The consignee, or his agent, shall or renderer within the 45-day time furnish such facilities and shall provide limit. Even if such title is illegally such assistance for handling and mark- transferred, the subsequent purchaser ing poultry products offered for entry will still be required to export the as the inspector may require. product or have it destroyed as speci- [37 FR 9706, May 16, 1972, as amended at 51 fied in the notice under paragraph FR 37710, Oct. 24, 1986; 54 FR 41050, Oct. 5, (a)(4) of this section. 1989; 56 FR 65180, Dec. 16, 1991] (3) No lot of product which has been § 381.201 Means of conveyance and refused entry may be subdivided during equipment used in handling poultry disposition pursuant to paragraph products offered for entry to be (a)(2) of this section, except that re- maintained in sanitary condition. moval and destruction of any damaged Compartments of steamships, rail- or otherwise unsound product from a road cars, and other means of convey- lot destined for reexportation is per- ance transporting any poultry product mitted under supervision of USDA to the United States, and all chutes, prior to exportation. Additionally, platforms, racks, tables, tools, uten- such refused entry lot may not be sils, and all other devices used in mov- shipped for export from any port other ing and handling any poultry product than that through which the product offered for entry into the United came into the United States without

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the expressed consent of the Adminis- in this subpart require to be marked in trator, based on full information con- any way, unless the same has been cerning the product’s disposition, in- clearly and legibly marked in compli- cluding the name of the vessel and the ance with this subpart. date of export. For the purposes of this (d) Any person receiving inspection paragraph, the term ‘‘lot’’ shall refer service may, if dissatisfied with any to that product identified on MP Form decision of an inspector relating to any 410 in the original request for inspec- inspection, file an appeal from such de- tion for importation pursuant to cision: Provided, That such appeal is § 381.198. filed within 48 hours from the time the (4) The owner or consignee shall have decision was made. Any such appeal 45 days after notice is given by FSIS to from a decision of an inspector shall be the Director of Customs at the original made to his/her immediate supervisor port of entry to take the action re- having jurisdiction over the subject quired in paragraph (a)(2) of this sec- matter of the appeal, and such super- tion for ‘‘refused entry’’ product. Ex- visor shall determine whether the in- tension beyond the 45-day period may spector’s decision was correct. Review be granted by the Administrator when of such appeal determination, when re- extreme circumstances warrant it; e.g., quested, shall be made by the imme- a dock workers’ strike or an unforesee- diate supervisor of the employee of the able vessel delay. Department making the appeal deter- (5) If the owner or consignee fails to mination. The cost of any such appeal take the required action within the shall be borne by the appellant if the time specified under paragraph (a)(4) of Administrator determines that the ap- this section, the Department will take peal is frivolous. The charges for such such actions as may be necessary to ef- frivolous appeal shall be at the rate of fectuate its order to have the product $9.28 per hour for the time required to destroyed for human food purposes. make the appeal inspection. The poul- The Department shall seek court costs try or poultry products involved in any and fees, storage, and proper expenses appeal shall be identified by U.S. rein the appropriate forum. tained tags and segregated in a manner (6) No product which has been refused entry and exported to another country approved by the inspector pending pursuant to paragraph (a)(2) of this sec- completion of an appeal inspection. tion may be returned to the United (e) All condemned carcasses, or con- States under any circumstance. Any demned parts of carcasses, or other such product so returned to the United condemned poultry products, except States shall be subject to administra- those condemned for biological resi- tive detention in accordance with sec- dues, shall be disposed of by one of the tion 19 of the Act, and seizure and con- following methods, under the super- demnation in accordance with section vision of an inspector of the Inspection 20 of the Act. Service. (Facilities and materials for (b) Upon the request of the Director carrying out the requirements in this of Customs at the port where a product section shall be furnished by the offi- is offered for clearance through the cial establishments.) customs, the consignee of the product (1) Steam treatment (which shall be shall, at the consignee’s own expense, accomplished by processing the con- immediately return to the Director demned product in a pressure tank any product which has been delivered under at least 40 pounds of steam pres- to consignee under this subpart and sure) or thorough cooking in a kettle subsequently designated ‘‘U.S. Refused or vat, a sufficient time to effectively Entry’’ or found in any request not to destroy the product for human food comply with the requirements in this purposes and preclude dissemination of subpart. disease through consumption by ani- (c) Except as provided in § 381.200(a) mals. (Tanks and equipment used for or (b), no person shall remove or cause this purpose or for rendering or pre- to be removed from any place des- paring inedible products shall be in ignated as the place of inspection, any rooms or compartments separate from poultry product which the regulations those used for the preparation of edible

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products. There shall be no direct con- cial inspection legend shown in para- nection by means of pipes, or other- graph (b) of this section. Such inspec- wise, between tanks containing ined- tion legend shall be placed upon such ible products and those containing edi- products only after completion of offi- ble products.) cial import inspection and product ac- (2) Incineration or complete destruc- ceptance. tion by burning. (b) The official mark for marking (3) Chemical denaturing, which shall poultry products offered for entry as be accomplished by the liberal applica- ‘‘U.S. inspected and passed’’ shall be in tion to all carcasses and parts thereof, the following form, and any device ap- of: proved by the Administrator for apply- (i) Crude carbolic acid, ing such mark shall be an official de- (ii) Kerosene, fuel oil, or used crank- vice. 2 case oil, or (iii) Any phenolic disinfectant conforming to commercial standards CS 70–41 or CS 71–41 which shall be used in at least 2 percent emulsion or solution. (4) Any other substances or method that the Administrator approves in specific cases, which will denature the poultry product to the extent necessary to accomplish the purposes of this section. (5) Carcasses and parts of carcasses condemned for biological residue shall be disposed of in accordance with paragraph (e)(2) of this section or by burying under the supervision of an inspector. [37 FR 9706, May 16, 1972, as amended at 48 FR 15890, Apr. 13, 1983; 50 FR 19908, May 13, 1985; 51 FR 37709, Oct. 24, 1986; 53 FR 17015, May 13, 1988; 54 FR 50735, Dec. 11, 1989; 60 FR FIGURE 1 67458, Dec. 29, 1995] (c) When products are refused entry into the United States, the official § 381.203 Products offered for entry; mark to be applied to the products re- charges for storage, cartage, and fused entry shall be in the following labor with respect to products which are refused entry. form: All charges for storage, cartage, and labor with respect to any product offered for entry which is refused entry pursuant to the regulations shall be paid by the owner or consignee and, in default of such payment, shall constitute a lien against any other products offered for entry thereafter by or for such owner or consignee. FIGURE 2 [54 FR 41050, Oct. 5, 1989] (d) The import warning notice prescribed in § 381.200(c) is an official § 381.204 Marking of poultry products offered for entry; official import in- mark. spection marks and devices. 2 (a) Except for products offered for The number ‘‘I–42’’ is given as an example only. The establishment number of the offi- entry from Canada, poultry products cial establishment or official import inspec- which upon reinspection are found to tion establishment where the product was in- be acceptable for entry into the United spected shall be shown on each stamp im- States shall be marked with the offi- pression.

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(e) The ordering and manufacture of thereto. If the cancellation is oral, the brands shall be in accordance with the decision and the reasons therefor shall provisions contained in § 317.3(c) of the be confirmed in writing, as promptly as Federal meat inspection regulations. circumstances allow. Any person whose (f) The inspection legend may be controlled pre-stamping privilege has placed on containers of product before been cancelled may appeal the decision completion of official import inspec- to the Administrator, in writing, with- tion if the containers are being in- in ten (10) days after receiving written spected by an import inspector who re- notification of the cancellation. The ports to an Import Field Office Super- appeal shall state all of the facts and visor, the product is not required to be reasons upon which the person relies to held at the establishment pending the show that the controlled pre-stamping receipt of laboratory test results; and a was wrongfully cancelled. The Admin- written procedure for controlled istrator shall grant or deny the appeal, stamping, submitted by the import es- in writing, stating the reasons for such tablishment and approved by the Direc- decision, as promptly as circumstances tor, Import Inspection Division, is on allow. If there is a conflict as to any file at the import inspection facility material fact, a hearing shall be held where the inspection is to be per- to resolve such conflict. Rules of prac- formed. tice concerning such a hearing will be (1) The written procedure for con- adopted by the Administrator. The trolled pre-stamping should be in the cancellation of the controlled pre- form of a letter and shall include the stamping privilege will be in effect following: until there is a final determination in (i) That stamping under this subpart the proceeding. will be limited to those lots of product which can be inspected on the day that (Approved by the Office of Management and certificates for the product are exam- Budget under control number 0583–0015) ined; [51 FR 37710, Oct. 24, 1986, as amended at 53 (ii) That all products which have FR 17015, May 13, 1988; 54 FR 41050, Oct. 5, been pre-stamped will be stored in the 1989] facility where the import inspection will occur; § 381.205 Labeling of immediate con- (iii) That inspection marks applied tainers of poultry products offered for entry. under this part will be removed from any lot of product subsequently refused (a) Immediate containers of poultry entry on the day the product is re- products imported into the United jected; and States shall bear a label printed in (iv) That the establishment will English showing in accordance with maintain a daily stamping log con- subpart N of this part all information taining the following information for required by that section (except that each lot of product: the date of inspec- the inspection mark and establishment tion, the country of origin, the foreign number assigned by the foreign poultry establishment number, the product inspection system and certified to the name, the number of units, the ship- Inspection Service shall be shown in- ping container marks, and the MP–410 stead of the official dressed poultry number covering the product to be in- identification mark or other official inspected. The daily stamping log must spection legend, and official establish- be retained by the establishment in ac- ment number); and in addition the cordance with the requirements of label shall show the name of the coun- § 381.177. try of origin preceded by the words (2) An establishment’s controlled pre- ‘‘Product of,’’ which statement shall stamping privilege may be cancelled appear immediately under the name of orally or in writing by the inspector the product. who is supervising its enforcement (b) The labels shall not be false or whenever the inspector finds that the misleading in any respect. establishment has failed to comply (c) All marks and other labeling for with the provisions of this subpart or use on or with immediate containers any conditions imposed pursuant shall be approved for use by the Food

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Safety and Inspection Service in ac- is exclusively for the personal use of cordance with §§ 381.132 and 381.133 be- said consignee, or for display or labora- fore products bearing such marks and tory analysis by said consignee, and other labeling will be permitted for not for sale or distribution. entry into the United States. [37 FR 9706, May 16, 1972, as amended at 54 [37 FR 9706, May 16, 1972, as amended at 39 FR 41050, Oct. 5, 1989] FR 4569, Feb. 5, 1974; 54 FR 41050, Oct. 5, 1989; 60 FR 67458, Dec. 29, 1995] § 381.208 Poultry products offered for entry and entered to be handled § 381.206 Labeling of shipping containers of poultry products offered and transported as domestic; entry for entry. into official establishments; transportation. Shipping containers of imported poultry products are required to bear (a) All poultry products, after entry in a prominent and legible manner the into the United States in compliance name of the product, the name of the with this subpart, shall be deemed and country of origin, the foreign inspec- treated and, except as provided in tion system establishment number of § 381.207, shall be handled and trans- the establishment in which the product ported as domestic products, and shall was processed, and the inspection mark be subject to the applicable provisions of the country of origin. Labeling on of this part and to the provisions of the shipping containers shall be examined Poultry Products Inspection Act and at the time of inspection in the United the Federal Food, Drug, and Cosmetic States and if found to be false or mis- Act. leading, the product shall be refused (b) Poultry products entered in ac- entry. All labeling used with a shipping cordance with this subpart may, sub- container of imported poultry products ject to the provisions of the regula- must be approved in accordance with tions, be taken into official establish- subpart N of this part. ments and be mixed with or added to [37 FR 9706, May 16, 1972, as amended at 54 poultry products that are inspected FR 41050, Oct. 5, 1989; 60 FR 67458, Dec. 29, and passed or exempted from inspec- 1995] tion in such establishments. § 381.207 Small importations for con- (c) Imported poultry products which signee’s personal use, display, or have been inspected, passed, and laboratory analysis. marked under this subpart may be Any poultry product (other than one transported in commerce, only upon which is forbidden entry by other Fed- compliance with the applicable regula- eral law or regulation) from any coun- tions. try in quantities of less than 50 pounds [37 FR 9706, May 16, 1972, as amended at 54 net weight, exclusively for the personal FR 41050, Oct. 5, 1989] use of the consignee, or for display or laboratory analysis by the consignee, § 381.209 Returned United States in- and not for sale or distribution; which spected and marked poultry prod- is sound, healthful, wholesome, and fit ucts; exemption. for human food, and which is not adul- Poultry products which have been in- terated and contains no substance not spected and passed by the U.S. Depart- permitted by the Act or regulations, ment of Agriculture and are so marked, may be imported into the United and are returned from foreign coun- States without a foreign inspection certificate, and such product is not re- tries, may be imported if they are not quired to be inspected upon arrival in adulterated or misbranded at the time the United States and may be shipped of such return. Such products are ex- to the consignee without further re- empted from further requirements striction under this part, except as pro- under this part. Such returned ship- vided in § 381.199(c): And provided, That ments shall be reported to the Admin- the Department may with respect to istrator by letter prior to arrival at the any specific importation, require that United States port of entry. the consignee certify that such product

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Subpart U—Detention; Seizure and at the time of detention and if the Condemnation; Criminal Offenses owner, or owner’s agent, can be ascertained and notified, an authorized § 381.210 Poultry and other articles representative of the Secretary shall subject to administrative detention. furnish a copy of the completed ‘‘No- Any poultry carcass, or part thereof; tice of Detention’’ to the owner, or the or any product made wholly or in part owner’s agent. Such copy shall be from any poultry carcass or part there- served, as soon as possible, by deliv- of; or any dead, dying, disabled, or dis- ering the notification to the owner, or eased poultry is subject to detention the owner’s agent, or by certifying and for a period not to exceed 20 days when mailing the notification to the owner, found by any authorized representative or the owner’s agent, at his or her last of the Secretary upon any premises known residence or principal office or where it is held for purposes of, or dur- place of business. ing or after distribution in commerce or otherwise subject to the Act, and [55 FR 47843, Nov. 16, 1990] there is reason to believe that any such § 381.213 Notification of governmental poultry or other article is adulterated authorities having jurisdiction over or misbranded and is capable of use as article detained; form of written no- human food or has not been inspected, tification. in violation of the provisions of the Act, any other Federal law, or the laws Within 48 hours after the detention of of any State or territory, or the Dis- any poultry or other article pursuant trict of Columbia; or that it has been to § 381.211, an authorized representa- or is intended to be distributed in vio- tive of the Secretary shall give oral or lation of the provisions of the Act, any written notification of such detention other Federal law, or the laws of any to any Federal authorities not con- State or territory, or the District of nected with the Inspection Service, and Columbia. any State or other governmental authorities, having jurisdiction over such § 381.211 Method of detention; form of article. In the event notification is detention tag. given orally, it shall be confirmed in An authorized representative of the writing, as promptly as circumstances Secretary shall detain any poultry or permit. other article to be detained under this subpart, by affixing an official ‘‘U.S. § 381.214 Movement of poultry or other Detained’’ tag (FSIS Form 8400–2) to article detained; removal of official marks. such article. (a) No poultry or other article de- [55 FR 47843, Nov. 16, 1990] tained in accordance with the provi- § 381.212 Notification of detention to sions in this subpart shall be moved by the owner of the poultry or other any person from the place at which it article, or the owner’s agent, and is located when so detained, until re- person having custody. leased by an authorized representative (a) When any poultry or other article of the Secretary: Provided, That any is detained under this subpart, an au- such article may be moved from the thorized representative of the Sec- place at which it is located when so de- retary shall: tained, for refrigeration or freezing, or (1) Orally notify the immediate cus- storage purposes if such movement has todian of the poultry or other article been approved by an authorized rep- detained, and resentative of the Secretary and the (2) Promptly furnish a copy of a com- article so moved will be further de- pleted ‘‘Notice of Detention’’ (FSIS tained by an authorized representative Form 8080–1) to the immediate custo- of the Secretary after such movement. dian of the detained poultry or other (b) Upon terminating the detention article. of such article, an authorized rep- (b) If the owner of the detained poul- resentative of the Secretary shall: try or other article, or the owner’s (1) Orally notify the immediate cus- agent, is not the immediate custodian todian of the released article, and

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(2) Furnish copies of a completed § 381.217 Authority for condemnation ‘‘Notice of Termination of Detention’’ or seizure under other provisions of (FSIS Form 8400–1) to the persons noti- law. fied when the article was detained. The The provisions of this subpart relat- notice shall be served by either deliv- ing to detention, seizure, condemna- ering the notice to such persons or by tion and disposition of poultry or other certifying and mailing the notice to articles do not derogate from authority such persons at their last known resi- for retention, condemnation, or seizure dences or principal offices or places of conferred by other provisions of the business. Act, or other laws. (c) All official marks may be required by such representative to be removed § 381.218 Criminal offenses. from such article before it is released The Act contains criminal provisions unless it appears to the satisfaction of with respect to numerous offenses spec- the representative that the article is ified in the Act, including but not lim- eligible to retain such marks. ited to forcible assaults on, or other interference with, any person while en- [37 FR 9706, May 16, 1972, as amended at 55 gaged in, or on account of the perform- FR 47843, Nov. 16, 1990] ance of, his official duties under the Act. Criminal provisions with respect § 381.215 Poultry or other articles sub- to gifts or offers of bribes to such per- ject to judicial seizure and condemnation. sons and related offenses are contained in the general criminal code (18 U.S.C. Any poultry carcass, or part thereof, 201). or any product made wholly or in part from any poultry carcass or part there- Subpart V—Special Provisions for of; except those exempted from the definition of a poultry product in § 381.15, Designated States and Terri- or any dead, dying, disabled, or dis- tories; Criteria and Procedure eased poultry, that is being trans- for Designating Establishments ported in commerce or is otherwise With Operations Which Would subject to the Act, or is held for sale in Clearly Endanger the Public the United States after such transpor- Health; Disposition of Poultry tation, is subject to seizure and con- Products Therein demnation, in a judicial proceeding pursuant to section 20 of the Act if § 381.220 Definition of ‘‘State’’. such poultry or other article: For purposes of this subpart, the (a) Is or has been processed, sold, term ‘‘State’’ means any State (includ- transported, or otherwise distributed ing the Commonwealth of Puerto Rico) or offered or received for distribution or organized territory. in violation of the Act; or (b) Is capable of use as human food § 381.221 Designation of States under paragraph 5(c) of the Act. and is adulterated or misbranded; or (c) In any other way is in violation of Each of the following States has been the Act. designated, under paragraph 5(c) of the Act, as a State in which the provisions § 381.216 Procedure for judicial sei- of sections 1 through 4, 6 through 10, zure, condemnation, and disposi- and 12 through 22 of the Act shall apply tion. to operations and transactions wholly within the State. The Federal provi- Any poultry or other article subject sions apply, effective on the dates to seizure and condemnation under this shown below: subpart is liable to be proceeded against and seized and condemned, and Effective date of disposed of, at any time, on an appro- application of States Federal provi- priate pleading in any U.S. district sions court, or other proper court specified Alaska ...... July 31, 1999. in section 21 of the Act, within the ju- Arkansas ...... Jan. 2, 1971. risdiction of which the article is found. California ...... Apr. 1, 1976.

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Effective date of cases that the interconnections are application of such that transfer of inedible poultry States Federal provisions product into the official establishment would be difficult or unusual, and any Colorado ...... Jan. 2, 1971. Connecticut ...... Oct. 1, 1975. such transfers are strictly prohibited, Florida ...... Dec. 2, 1997. except as permitted under other provi- Georgia ...... Jan. 2, 1971. sions of the regulations. It is essential Guam ...... Jan. 21, 1972. that separation of facilities be main- Hawaii ...... Nov. 1, 1995. Idaho ...... Jan. 2, 1971. tained to the extent necessary to as- Kentucky ...... July 28, 1971. sure that inedible poultry product does Maryland ...... Mar. 31, 1991. not enter the official establishment Massachusetts ...... Jan. 12, 1976. Michigan ...... Jan. 2, 1971. contrary to the regulations. Nebraska ...... July 28, 1971. (c) Sections 381.49 and 381.51 shall Nevada ...... July 1, 1973. apply to such establishments, except New Hampshire ...... Aug. 6, 1978 that separate facilities for men and New Jersey ...... Do. New Mexico ...... Aug. 13, 2007. women workers will not be required New York ...... Apr. 10, 1977. when the majority of the workers in Northern Mariana Islands ...... Oct. 29, 1979. the establishment are related by blood Oregon ...... Jan. 2, 1971. Pennsylvania ...... Oct. 31, 1971. or marriage, provided that this will not Puerto Rico ...... Jan. 17, 1972. conflict with municipal or State re- Rhode Island ...... Oct. 1, 1981. quirements; and except that separation South Dakota ...... Jan. 2, 1971. of toilet soil lines from house drainage Tennessee ...... Oct. 1, 1975. Virgin Islands ...... Nov. 27, 1971. lines to a point outside the buildings Washington ...... June 1, 1973. will not be required in existing construction when positive acting back- [42 FR 2949, Jan. 14, 1977] flow devices are installed. (d) Subpart N of this part shall apply EDITORIAL NOTE: For FEDERAL REGISTER ci- to such establishments except as pro- tations affecting § 381.221, see the List of CFR Sections Affected, which appears in the vided in this paragraph (d). Finding Aids section of the printed volume (1) The operator of each such estab- and at www.fdsys.gov. lishment shall, prior to the inauguration of inspection, identify all labeling § 381.222 States designated under and marking devices in use, or pro- paragraph 5(c) of the Act; applica- posed for use (upon the date of inau- tion of regulations. guration of inspection) to the Circuit The provisions of the regulations in Supervisor in which the establishment this part apply to operations and trans- is located. Temporary approval, pend- actions wholly within each State des- ing formal approval under § 381.132, will ignated in § 381.221 under paragraph 5(c) be granted by the Circuit Supervisor of the Act, except as otherwise pro- for labeling and marking devices that vided in this section. (The provisions of he determines are neither false nor the regulations apply in all respects to misleading, provided the official in- operations and transactions in or for spection legend bearing the official es- commerce.) tablishment number is applied to the (a) Each establishment located in principal display panel of each label, such a designated State, shall be grant- either by a mechanical printing device ed inspection required under § 381.6(b) or a self-destructive pressure sensitive only if it is found, upon a combined sticker, and provided the label shows evaluation of its premises, facilities, the true product name, an accurate in- and operating procedures, to be capable gredient statement, the name and ad- of producing products that are not dress of the manufacturer, packer, or adulterated or misbranded. distributor, and any other features re- (b) Section 381.26 will apply to estab- quired by paragraph 4(h) of the Act. lishments required to have inspection (2) The Circuit Supervisor will for- under § 381.6(b), except that existing ward one copy of each item of labeling interconnections between official and and a description of each marking de- unofficial establishments or between vice for which he has granted tem- official establishments will be per- porary approval to the Washington, mitted if it is determined in specific DC; office of the Labels and Packaging

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Staff and will retain one copy in a tem- erations and transactions solely in or porary approval file for the establish- for intrastate commerce. ment. (3) The operator of the official estab- [37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 62 FR 45027, Aug. 25, lishment shall promptly forward a copy 1997] of each item of labeling and a description of each marking device for which § 381.223 Control and disposition of temporary approval has been granted nonfederally inspected poultry by the Circuit Supervisor (showing any products in States designated modifications required by the Circuit under paragraph 5(c) of the Act. Supervisor) to the Labels and Pack- Upon the effective date of designa- aging Staff, Meat and Poultry Inspec- tion of a State under paragraph 5(c) of tion Food Safety and Inspection Serv- the Act, no poultry products can be ice, U.S. Department of Agriculture, processed within the State unless they Washington, DC 20250, accompanied by are prepared under inspection pursuant the formula and details of preparation and packaging for each product. Within to the regulations or are exempted 90 days after inauguration of inspec- from the requirement of inspection tion, all labeling material and marking under § 381.10, and no unexempted poul- devices temporarily approved by the try products which were processed Circuit Supervisor must receive ap- without any inspection can lawfully be proval as required by § 381.132 or their distributed within the State. For a pe- use must be discontinued. riod of 90 days from the effective date (4) The Circuit Supervisor will also of such designation, poultry products review all shipping containers to insure which were processed in any State list- that they do not have any false or mis- ed in § 381.187 and inspected and passed leading labeling and are otherwise not under the supervision of a responsible misbranded. Modifications of unaccept- State or local inspection agency or ex- able information on labeling material empted from State inspection can be by the use of pressure sensitive tape of distributed solely within the State, a type that cannot be removed without provided they are not adulterated or visible evidence of such removal, or by misbranded, except that the official in- blocking out with an ink stamp will be spection legend shall not be used. Such authorized on a temporary basis to per- products may not enter official estab- mit the maximum allowable use of all lishments. After said 90-day period, labeling materials on hand. All unac- only federally inspected and passed ceptable labeling material which is not products may be distributed within the modified to comply with the require- designated State, except as provided in ments of the regulations must be de- § 381.10. stroyed or removed from the official establishment. § 381.224 Designation of States under (e) Sections 381.175 through 381.179 section 11 of the Act; application of apply to operations and transactions sections of the Act and the regula- not in or for commerce in a State des- tions. ignated under paragraph 5(c) only if Each of the following States has been the State is also designated under sec- designated, effective on the date shown tion 11 of the Act and if such provisions below, under section 11 of the Act, as a are applicable as shown in § 381.224. State in which the provisions of the (f) Section 381.185(a) will not apply to sections of the Act and regulations States designated under paragraph 5(c) specified below shall apply to operators of the Act. engaged, other than in or for com- (g) Provisions of this part relating to merce, in the kinds of business indi- exports and imports do not apply to op- cated below:

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Paragraphs of act and regulations Classes of operators State Effective date

Act, 11(b): §§ 381.175– Persons engaged (not in or for commerce) in (1) the busi- Alaska ...... July 31, 1999. 381.178. ness of slaughtering any poultry or processing, freezing, Arkansas ...... Apr. 1, 1976. packaging, or labeling any poultry carcasses, or parts or California ...... July 1, 1975. products thereof, for use as human food or animal food; Colorado ...... Oct. 1, 1975. (2) the business of buying or selling (as a poultry products Connecticut ...... Nov. 12, 1976. broker, wholesaler, or otherwise), transporting or storing Georgia ...... Nov. 19, 1976. any poultry carcasses, or parts or products thereof; or (3) Guam ...... Nov. 12, 1976. business as a renderer or in the business of buying, sell- Idaho ...... Apr. 18, 1973. ing, or transporting any dead, dying, disabled, or diseased Kentucky ...... Nov. 12, 1976. poultry or parts of carcasses of any poultry that died other- Maryland ...... Jan. 12, 1976. wise than by slaughter. Massachusetts ... Nov. 12, 1976. Michigan ...... Jan. 31, 1975. Nebraska ...... Jan. 31, 1975. Nevada ...... Oct. 29, 1979. New Hampshire .. July 1, 1975. New Jersey ...... July 16, 1975. New York ...... July 23, 1973. Northern Mariana Oct. 29, 1979. Islands. Jan. 31, 1975. Oregon ...... Pennsylvania ...... May 2, 1974. Puerto Rico ...... Nov. 19, 1976. Rhode Island ...... Mar. 29, 1982. South Dakota ..... Nov. 12, 1976. Tennessee ...... Oct. 1, 1975. Virgin Islands ...... Nov. 19, 1976. Washington ...... Jan. 31, 1975. Nov. 12, 1976. Act, 11(c); § 381.179 ...... Persons engaged (not in or for commerce) in business as a Alaska ...... July 31, 1999. poultry products broker; renderer; animal food manufac- Arkansas ...... Apr. 1, 1976. turer; wholesaler or public warehouseman of poultry car- California ...... July 1, 1975. casses, or parts or products thereof; or buying, selling, or Colorado ...... Oct. 1, 1975. transporting dead, dying, disabled, or diseased poultry or Connecticut ...... Nov. 12, 1976. parts of carcasses of any poultry that died otherwise than Georgia ...... Nov. 19, 1976. by slaughter. Guam ...... Nov. 12, 1976. Idaho ...... Apr. 18, 1973. Kentucky ...... Nov. 12, 1976. Maryland ...... Jan. 12, 1976. Massachusetts ... Nov. 12, 1976. Michigan ...... Jan. 31, 1975. Nebraska ...... Jan. 31, 1975. Nevada ...... Oct. 29, 1979. New Hampshire .. July 1, 1975. New Jersey ...... July 16, 1975. New York ...... July 23, 1973. Northern Mariana Oct. 29, 1979. Islands. Jan. 31, 1975. Oregon ...... Pennsylvania ...... May 2, 1974. Puerto Rico ...... Nov. 19, 1976. Rhode Island ...... Mar. 29, 1982. South Dakota ..... Nov. 12, 1976. Tennessee ...... Oct. 1, 1975. Virgin Islands ...... Nov. 19, 1976. Washington ...... Jan. 31, 1975. Nov. 12, 1976.

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Paragraphs of act and regulations Classes of operators State Effective date

Act, 11(d); 381.194 ...... Persons engaged (not in or for commerce) in the business of Alaska ...... July 31, 1999. buying, selling or transporting any dead, dying, disabled or Arkansas ...... Nov. 12, 1976. diseased poultry, or parts or carcasses of any poultry that Georgia ...... Nov. 19, 1976. died otherwise than by slaughter. Guam ...... Nov. 12, 1976. Idaho ...... Nov. 12, 1976. Maryland ...... Nov. 12, 1976. Michigan ...... Oct. 29, 1979. New Hampshire .. Oct. 29, 1979. Northern Mariana Nov. 19, 1976. Islands. Puerto Rico ...... Mar. 29, 1982. Rhode Island ...... Nov. 12, 1976. South Dakota ..... Nov. 19, 1976. Virgin Islands ...... Nov. 12, 1976.

[37 FR 9706, May 16, 1972; 65 FR 6888, Feb. 11, 2000]

EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 381.224, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

§ 381.225 Criteria and procedure for demned under subpart K at official es- designating establishments with op- tablishments; or erations which would clearly en- (iii) It has been prepared, packed or danger the public health; disposi- held under insanitary conditions tion of poultry products therein. whereby it may have become contami- (a) An establishment in any State nated with filth or may have been ren- not listed in § 381.221 that is preparing dered injurious to health (for example, poultry products solely for distribution if insects or vermin are not effectively within such State shall be designated controlled at the establishment, or in- as one producing adulterated products sanitary water is used in preparing which would clearly endanger the pub- poultry products for human food); or lic health, if: (iv) It is, in whole or in part, the (1) Any poultry product processed at product of poultry that died otherwise the establishment is adulterated in any than by slaughter; or of the following respects: (v) Its container is composed, in (i) It bears or contains a pesticide whole or in part, of any poisonous or chemical, food additive, or color addi- deleterious substance which may tive, that is ‘‘unsafe’’ within the mean- render the contents injurious to ing of section 408, 409, or 706 of the Fed- health; and eral Food, Drug, and Cosmetic Act or (2) Such adulterated articles are in- was intentionally subjected to radi- tended to be or are distributed from ation in a manner not permitted under the establishment while capable of use section 409 of said Act; or if it bears or as human food. contains any other added poisonous or (b) When any such establishment is added deleterious substance which may identified by an inspector as one pro- render it injurious to health or make it ducing adulterated poultry products unfit for human food; or which would clearly endanger public (ii) It consists in whole or in part of health under the criteria in paragraph any filthy, putrid or decomposed sub- (a) of this section, the following proce- stance or is for any other reason un- dure will be followed: sound, unhealthful, unwholesome, or (1) The inspector will informally ad- otherwise unfit for human food (for ex- vise the operator of the establishment ample, it was prepared from a poultry concerning the deficiencies found by carcass or other ingredients exhibiting him and report his findings to the ap- spoilage characteristics); or it is, or propriate Regional Director for the In- was prepared from, a poultry carcass spection Service. When it is deter- which would be required to be con- mined by the Regional Director that

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any establishment preparing poultry (d) No establishment designated products solely for distribution within under this section can lawfully prepare any State is producing adulterated any poultry products unless it first ob- poultry products for distribution with- tains inspection or qualifies for exemp- in such State which would clearly en- tion under § 381.10 of this subpart. All danger the public health, written noti- other provisions of the regulations fication thereof will be issued to the shall apply to establishments des- appropriate State officials, including ignated under this section to the same the Governor of the State and the ap- extent and in the same manner as if propriate Advisory Committee, for ef- they were engaged in commerce, except fective action under State or local law that the exceptions provided for in to prevent such endangering of the § 381.222 shall apply to such establish- public health. Such written notifica- ments. tion shall clearly specify the deficiencies deemed to result in the pro- Subpart X—Canning and Canned duction of adulterated poultry prod- Products ucts and shall specify a reasonable time for such action under State or SOURCE: 51 FR 45634, Dec. 19, 1986, unless local law. otherwise noted. (2) If effective action is not taken under State or local law within the § 381.300 Definitions. specified time, written notification (a) Abnormal container. A container shall be issued by the Regional Direc- with any sign of swelling or product tor to the operator of the establish- leakage or any evidence that the con- ment, specifying the deficiencies in- tents of the unopened container may be volved and allowing him 10 days to spoiled. present his views or make the nec- (b) Acidified low acid product. A essary corrections, and notifying him canned product which has been formu- that failure to correct such deficiencies lated or treated so that every compo- may result in designation of the estab- nent of the finished product has a pH of lishment and operator thereof as sub- 4.6 or lower within 24 hours after the ject to the provisions of sections 1 completion of the thermal process un- through 4, 6 through 10, and 12 through less data are available from the estab- 22 of the Act as though engaged in lishment’s processing authority dem- commerce. onstrating that a longer time period is (3) Thereafter the inspector shall sur- safe. vey the establishment and designate it (c) Bleeders. Small orifices on a retort if he determines, in consultation with through which steam, other gasses, and the Regional Director, that it is pro- condensate are emitted from the retort ducing adulterated poultry products, throughout the entire thermal process. which would clearly endanger the pub- (d) Canned product. A poultry food lic health, and formal notice of such product with a water activity above designation will be issued to the oper- 0.85 which receives a thermal process ator of the establishment by the Re- either before or after being packed in a gional Director. hermetically sealed container. Unless (c) Poultry products on hand at the otherwise specified, the term ‘‘prod- time of designation of an establish- uct’’ as used in this subpart G shall ment under this section are subject to mean ‘‘canned product.’’ retention or detention, and seizure and (e) Closure technician. The indi- condemnation in accordance with vidual(s) identified by the establish- § 381.145 or subpart U of this part: Pro- ment as being trained to perform spe- vided, That poultry products that have cific container integrity examinations been federally inspected and so identi- as required by this subpart and des- fied and that have not been further pre- ignated by the establishment to per- pared at any nonfederally inspected es- form such examinations. tablishment may be released for dis- (f) Code lot. All production of a par- tribution if the products appear to be ticular product in a specific size con- not adulterated or misbranded at the tainer marked with a specific con- time of such release. tainer code.

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(g) Come-up time. The elapsed time, thermal process cycle, of the contents including venting time (if applicable), of the coldest container to be proc- between the introduction of the heat- essed. ing medium into a closed retort and (m) Low acid product. A canned prod- the start of process timing. uct in which any component has a pH (h) Critical factor. Any characteristic, value above 4.6. condition or aspect of a product, con- (n) Process schedule. The thermal tainer, or procedure that affects the process and any specified critical fac- adequacy of the process schedule. Crit- tors for a given canned product re- ical factors are established by proc- quired to achieve shelf stability. essing authorities. (i) Headspace. That portion of a con- (o) Process temperature. The minimum tainer not occupied by the product. temperature(s) of the heating medium (1) Gross headspace. The vertical dis- to be maintained as specified in the tance between the level of the product process schedule. (generally the liquid surface) in an up- (p) Process time. The intended time(s) right rigid container and the top edge a container is to be exposed to the of the container (i.e., the flange of an heating medium while the heating me- unsealed can, the top of the double dium is at or above the process tem- seam on a sealed can, or the top edge of perature(s). an unsealed jar). (q) Processing authority. The person(s) (2) Net headspace. The vertical dis- or organization(s) having expert knowl- tance between the level of the product edge of thermal processing require- (generally the liquid surface) in an up- ments for foods in hermetically sealed right rigid container and the inside containers, having access to facilities surface of the lid. for making such determinations, and (j) Hermetically sealed containers. Air- designated by the establishment to per- tight containers which are designed form certain functions as indicated in and intended to protect the contents this subpart. against the entry of microorganisms (r) Program employee. Any inspector during and after thermal processing. or other individual employed by the (1) Rigid container. A container, the shape or contour of which, when filled Department or any cooperating agency and sealed, is neither affected by the who is authorized by the Secretary to enclosed product nor deformed by ex- do any work or perform any duty in ternal mechanical pressure of up to 10 connection with the Program (see pounds per square inch gauge (0.7 kg/ § 301.2(f)). cm2) (i.e., normal firm finger pressure). (s) Retort. A pressure vessel designed (2) Semirigid container. A container, for thermal processing of product the shape or contour of which, when packed in hermetically sealed con- filled and sealed, is not significantly tainers. affected by the enclosed product under (t) Seals. Those parts of a semirigid normal atmospheric temperature and container and lid or of a flexible con- pressure, but can be deformed by exter- tainer that are fused together in order nal mechanical pressure of less than 10 to hermetically close the container. pounds per square inch gauge (0.7 kg/ (u) Shelf stability. The condition 2 cm ) (i.e., normal firm finger pressure). achieved by application of heat, suffi- (3) Flexible container. A container, the cient, alone or in combination with shape or contour of which, when filled other ingredients and/or treatments, to and sealed, is significantly affected by render the product free of microorga- the enclosed product. nisms capable of growing in the prod- (k) Incubation tests. Tests in which the thermally processed product is uct at nonrefrigerated conditions (over ° ° kept at a specific temperature for a 50 F or 10 C) at which the product is specified period of time in order to de- intended to be held during distribution termine if outgrowth of microorga- and storage. Shelf stability and shelf nisms occurs. stable are synonymous with commer- (l) Initial temperature. The tempera- cial sterility and commercially sterile, ture, determined at the initiation of a respectively.

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(v) Thermal process. The heat treat- examinations shall be conducted with ment necessary to achieve shelf sta- sufficient frequency to ensure proper bility as determined by the establish- closure and should be conducted at ment’s processing authority. It is least every 30 minutes of continuous quantified in terms of: closing machine operation. Additional (1) Time(s) and temperature(s); or visual examinations shall be made by (2) Minimum product temperature. the closure technician at the beginning (w) Venting. The removal of air from of production, immediately following a retort before the start of process tim- every jam in the closing machine and ing. after closing machine adjustment (in- (x) Water activity. The ratio of the cluding adjustment for changes in con- water vapor pressure of the product to tainer size). the vapor pressure of pure water at the (2) Teardown examinations. Teardown same temperature. examinations of double seams formed by each closing machine head shall be § 381.301 Containers and closures. performed by a closure technician at a (a) Examination and cleaning of empty frequency sufficient to ensure proper containers. (1) Empty containers, clo- closure. These examinations should be sures, and flexible pouch roll stock made at intervals of not more than 4 shall be evaluated by the establish- hours of continuous closing machine ment to ensure that they are clean and operation. At least one container from free of structural defects and damage each closing head shall be examined on that may affect product or container the packer’s end during each regular integrity. Such an examination should examination period. Examination re- be based upon a statistical sampling sults along with any necessary correc- plan. tive actions, such as adjusting or re- (2) All empty containers, closures, pairing the closing machine, shall be and flexible pouch roll stock shall be promptly recorded by the closure tech- stored, handled, and conveyed in such a nician. The establishment shall have manner that will prevent soiling and container specification guidelines for damage that could affect the hermetic double seam integrity on file and avail- condition of the sealed container. able for review by Program employees. (3) Just before filling, rigid con- A teardown examination of the can tainers shall be cleaned to prevent in- maker’s end shall be performed on at corporation of foreign matter into the least one container selected from each finished product. Closures, semirigid closing machine during each examina- containers, preformed flexible pouches, tion period except when teardown ex- and flexible pouch roll stock contained aminations are made on incoming in original wrappings do not need to be empty containers or when, in the case cleaned before use. of self-manufactured containers, the (b) Closure examinations for rigid con- containers are made in the vicinity of tainers (cans). (1) Visual examinations. the establishment and the container A closure technician shall visually ex- plant records are made available to amine the double seams formed by Program employees. Additional tear- each closing machine head. When seam down examinations on the packer’s end defects (e.g., cutovers, sharpness, should be made at the beginning of pro- knocked down flanges, false seams, duction, immediately following every droops) are observed, necessary correc- jam in a closing machine and after tive actions, such as adjusting or re- closing machine adjustment (including pairing the closing machine, shall be adjustment for a change in container taken. In addition to the double seams, size). The following procedures shall be the entire container shall be examined used in teardown examinations of dou- for product leakage or obvious defects. ble seams: A visual examination shall be per- (i) One of the following two methods formed on at least one container from shall be employed for dimensional each closing machine head, and the ob- measurements of the double seam. servations, along with any corrective (a) Micrometer measurement. For cylin- actions, shall be recorded. Visual ex- drical containers, measure the fol- aminations shall be recorded. Visual lowing dimensions (Figure 1) at three

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points approximately 120 degrees apart ‘‘D’’-shaped, and irregularly-shaped) on the double seam excluding and at shall be conducted as described in para- least one-half inch from the side seam graphs (b)(2) (i), (ii), and (iii) of this juncture: section except that the required dimen- (1) Double seam length—W; sional measurements shall be made on (2) Double seam thickness—S; the double seam at the points listed in (3) Body hook length—BH; and the establishment’s container speci- (4) Cover hook length—CH. fication guidelines. Maximum and minimum values for (c) Closure examinations for glass con- each dimensional measurement shall tainers—(1) Visual examinations. A clo- be recorded by the closure technician. sure technician shall visually assess the adequacy of the closures formed by each closing machine. When closure defects, such as loose or cocked caps, fractured or cracked containers and low vacuum jars, are observed, necessary corrective actions, such as adjusting or repairing the closing machine, shall be taken and recorded. In addition to the closures, the entire container shall be examined for defects. Visual examinations shall be made with sufficient frequency to ensure proper closure and should be conducted at least every 30 minutes of continuous closing machine operation. Ad- ditional visual examinations shall be made by the closure technician and the observations recorded at the beginning of production, immediately following every jam in the closing machine, and after closing machine adjustment (including adjustment for a change in (b) Seamscope or seam projector. Re- container size). quired measurements of the seam in- (2) Closure examinations and tests. De- clude thickness, body hook, and over- pending upon the container and clo- lap. Seam thickness shall be obtained sure, tests shall be performed by a clo- by micrometer. For cylindrical con- sure technician at a frequency suffi- tainers, at least two locations, exclud- cient to ensure proper closure. These ing the side seam juncture, shall be examinations should be made either used to obtain the required measure- before or after thermal processing and ments. at intervals of not more than 4 hours of (ii) Seam tightness. Regardless of the continuous closing machine operation. dimensional measurement method used At least one container from each clos- to measure seam dimensions, at a mining machine shall be examined during imum, the seam(s) examined shall be each regular examination period. Ex- stripped to assess the degree of wrin- amination results along with any nec- kling. essary corrective actions, such as ad- (iii) Side seam juncture rating. Regard- justing or repairing the closing ma- less of the dimensional measurement chine, shall be promptly recorded by method used to measure seam dimen- the closure technician. The establish- sions, the cover hook shall be stripped ment shall have specification guide- to examine the cover hook droop at the lines for closure integrity on file and juncture for containers having side available for review by Program em- seams. ployees. Additional closure examina- (iv) Examination of noncylindrical con- tions should be made at the beginning tainers. Examination of noncylindrical of production, immediately following containers (e.g., square, rectangular, every jam in the closing machine and

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after closing machine adjustment (in- the hermetic condition of the con- cluding adjustment for a change in tainers. The accumulation of sta- container size). tionary containers on moving con- (d) Closure examinations for semirigid veyors should be minimized to avoid and flexible containers—(1) Heat seals— damage to the containers. (i) Visual examinations. A closure tech- (2) The maximum time lapse between nician shall visually examine the seals closing and initiation of thermal proc- formed by each sealing machine. When essing shall be 2 hours. However, the sealing defects are observed, necessary Administrator may specify a shorter corrective actions, such as adjusting or period of time when considered nec- repairing the sealing machine, shall be essary to ensure product safety and taken and recorded. In addition to ex- stability. A longer period of time be- amining the heat seals, the entire con- tween closing and the initiation of tainer shall be examined for product thermal processing may be permitted leakage or obvious defects. Visual ex- by the Administrator. aminations shall be performed before and after the thermal processing oper- (Approved by the Office of Management and Budget under control number 0583–0015) ation with sufficient frequency to ensure proper closure. These examina- § 381.302 Thermal processing. tions should be conducted at least in accordance with a statistical sampling (a) Process schedules. Prior to the plan. All defects noted and corrective processing of canned product for dis- actions taken shall be promptly re- tribution in commerce, an establish- corded. ment shall have a process schedule (as (ii) Physical tests. Tests determined defined in § 381.300(n) of this subpart) by the establishment as necessary to for each canned poultry product to be assess container integrity shall be con- packed by the establishment. ducted by the closure technician at a (b) Source of process schedules. (1) frequency sufficient to ensure proper Process schedules used by an establish- closure. These tests shall be performed ment shall be developed or determined after the thermal processing operation by a processing authority. and should be made at least every 2 (2) Any change in product formula- hours of continuous production. The tion, ingredients, or treatments that establishment’s acceptance guidelines are not already incorporated in a proc- for each test procedure shall be on file ess schedule and that may adversely af- and available for review by Program fect either the product heat penetra- employees. Test results along with any tion profile or sterilization value re- necessary corrective actions, such as quirements shall be evaluated by the adjusting or repairing the sealing ma- establishment’s processing authority. chine, shall be recorded. If it is determined that any such (2) Double seams on semirigid or change adversely affects the adequacy flexible containers shall be examined of the process schedule, the processing and the results recorded as provided in authority shall amend the process paragraph (b) of this section. Any addi- schedule accordingly. tional measurements specified by the (3) Complete records concerning all container manufacturer shall also be aspects of the development or deter- made and recorded. mination of a process schedule, includ- (e) Container coding. Each container ing any associated incubation tests, shall be marked with a permanent, leg- shall be made available by the estab- ible, identifying code mark. The mark lishment to the Program employee shall, at a minimum, identify in code upon request. the product (unless the product name (c) Submittal of process information. (1) is lithographed or printed elsewhere on Prior to the processing of canned prod- the container) and the day and year uct for distribution in commerce, the the product was packed. establishment shall provide the inspec- (f) Handling of containers after closure. tor at the establishment with a list of (1) Containers and closures shall be the process schedules (including alter- protected from damage which may nate schedules) along with any addi- cause defects that are likely to affect tional applicable information, such as

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the retort come-up operating proce- (b) Continuous rotary and batch agi- dures and critical factors. tating retorts. (1) Minimum headspace; (2) Letters or other written commu- and nications from a processing authority (2) Retort reel speed. recommending all process schedules (c) Hydrostatic retorts. (1) Chain or shall be maintained on file by the es- conveyor speed. tablishment. Upon request by Program (d) Steam/air retorts. (1) Steam/air employees, the establishment shall ratio; and make available such letters or written (2) Heating medium flow rate. communications (or copies thereof). If (Approved by the Office of Management and critical factors are identified in the Budget under control number 0583–0015) process schedule, the establishment shall provide the inspector with a copy § 381.304 Operations in the thermal of the procedures for measuring, con- processing area. trolling, and recording these factors, (a) Posting of processes. Process sched- along with the frequency of such meas- ules (or operating process schedules) urements, to ensure that the critical for daily production, including min- factors remain within the limits used imum initial temperatures and oper- to establish the process schedule. Once ating procedures for thermal proc- submitted, the process schedules and essing equipment, shall be posted in a associated critical factors and the pro- conspicuous place near the thermal cedures for measuring (including the processing equipment. Alternatively, frequency), controlling, and recording such information shall be available to of critical factors shall not be changed the thermal processing system oper- without the prior written submittal of ator and the inspector. the revised procedures (including sup- (b) Process indicators and retort traffic porting documentation) to the inspec- control. A system for product traffic tor at the establishment. control shall be established to prevent product from bypassing the thermal (Approved by the Office of Management and Budget under control number 0583–0015) processing operation. Each basket, crate or similar vehicle containing un- § 381.303 Critical factors and the appli- processed product, or at least one visi- cation of the process schedule. ble container in each vehicle, shall be plainly and conspicuously marked with Critical factors specified in the proc- a heat sensitive indicator that will vis- ess schedule shall be measured, con- ually indicate whether such unit has trolled and recorded by the establish- been thermally processed. Exposed ment to ensure that these factors re- heat sensitive indicators attached to main within the limits used to estab- container vehicles shall be removed be- lish the process schedule. Examples of fore such vehicles are refilled with un- factors that are often critical to proc- processed product. Container loading ess schedule adequacy may include: systems for crateless retorts shall be (a) General. (1) Maximum fill-in designed to prevent unprocessed prod- weight or drained weight; uct from bypassing the thermal proc- (2) Arrangement of pieces in the con- essing operation. tainer; (c) Initial temperature. The initial (3) Container orientation during ther- temperature of the contents of the mal processing; coldest container to be processed shall (4) Product formulation; be determined and recorded by the es- (5) Particle size; tablishment at the time the processing (6) Maximum thickness for flexible, cycle begins to assure that the tem- and to some extent semirigid con- perature of the contents of every containers during thermal processing; tainer to be processed is not lower than (7) Maximum pH; the minimum initial temperature spec- (8) Percent salt; ified in the process schedule. Thermal (9) Ingoing (or formulated) nitrite processing systems which subject the level (ppm); filled and sealed containers to water at (10) Maximum water activity; and any time before process timing begins (11) Product consistency or viscosity. shall be operated to assure that such

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water will not lower the temperature ment and made available to Program of the product below the minimum ini- employees. A mercury-in-glass ther- tial temperature specified in the proc- mometer that has a divided mercury ess schedule. column or that cannot be adjusted to (d) Timing devices. Devices used to the standard shall be repaired and test- time applicable thermal processing oped for accuracy before further use, or eration functions or events, such as replaced. process schedule time, come-up time (ii) Other devices. Temperature-indi- and retort venting, shall be accurate to cating devices used in lieu of mercury- assure that all such functions or events in-glass thermometers, such as resist- are achieved. Pocket watches and wrist ance temperature detectors, shall meet watches are not considered acceptable known, accurate standards for such de- timing devices. Analog and digital vices when tested for accuracy. The clocks are considered acceptable. If records of such testing shall be avail- such clocks do not display seconds, all able to FSIS program employees. required timed functions or events (2) Temperature/time recording devices. shall have at least a 1-minute safety Each thermal processing system shall factor over the specified thermal proc- be equipped with at least one tempera- essing operation times. Temperature/ ture/time recording device to provide a time recording devices shall correspond permanent record of temperatures within 15 minutes to the time of the within the thermal processing system. day recorded on written records re- This recording device may be combined quired by § 381.306. with the steam controller and may be a (e) Measurement of pH. Unless other recording/controlling instrument. methods are approved by the Adminis- When compared to the known accurate trator, potentiometric methods using indicating temperature device, the re- electronic instruments (pH meters) cording accuracy shall be equal to or shall be used for making pH determina- better than 1 °F (or 0.5 °C) at the proc- tions when a maximum pH value is ess temperature. The temperature re- specified as a critical factor in a proc- cording chart should be adjusted to ess schedule. agree with, but shall never be higher than, the known accurate indicating § 381.305 Equipment and procedures temperature device. A means of pre- for heat processing systems. venting unauthorized changes in the (a) Instruments and controls common to adjustment shall be provided. For ex- different thermal processing systems—(1) ample, a lock or a notice from manage- Indicating temperature devices. Each re- ment posted at or near the recording tort shall be equipped with at least one device warning that only authorized indicating temperature device that persons are permitted to make adjust- measures the actual temperature with- ments, are satisfactory means for pre- in the retort. The indicating tempera- venting unauthorized changes. Air-op- ture device, not the temperature/time erated temperature controllers shall recording device, shall be used as the have adequate filter systems to ensure reference instrument for indicating the a supply of clean, dry air. The recorder process temperature. timing mechanism shall be accurate. (i) Mercury-in-glass thermometers. A (i) Chart-type devices. Devices using mercury-in-glass thermometer shall charts shall be used only with the cor- have divisions that are readable to 1 °F rect chart. Each chart shall have a (or 0.5 °C) and whose scale contains not working scale of not more than 55 °F/ more than 17 °F/inch (or 4.0 °C/cm) of inch (or 12 °C/cm) within a range of 20 graduated scale. Each mercury-in-glass °F (or 11 °C) of the process tempera- thermometer shall be tested for accu- ture. Chart graduations shall not ex- racy against a known accurate stand- ceed 2 °F (or 1 °C) within a range of 10 ard upon installation and at least once °F (or 5 °C) of the process temperature. a year to ensure its accuracy. Records Multipoint plotting chart-type devices that specify the date, standard used, shall print temperature readings at in- test method, and the person or testing tervals that will assure that the pa- authority performing the test shall be rameters of the process time and proc- maintained on file by the establish- ess temperature have been met. The

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frequency of recording should not ex- provide steam for proper operation of ceed 1-minute intervals. the retort, and shall enter at a point to (ii) Other devices. Temperature/time facilitate air removal during venting. recording devices or procedures used in (iv) Crate supports. Vertical still re- lieu of chart-type devices must meet torts with bottom steam entry shall known accurate standards for such de- employ bottom retort crate supports. vices or procedures when tested for ac- Baffle plates shall not be used in the curacy. Such a device must be accurate bottom of retorts. enough for ensuring that process time (v) Steam spreader. Perforated steam and temperature parameters have been spreaders, if used, shall be maintained met. to ensure they are not blocked or oth- (3) Steam controllers. Each retort shall erwise inoperative. Horizontal still re- be equipped with an automatic steam torts shall be equipped with perforated controller to maintain the retort tem- steam spreaders that extend the full perature. This may be a recording/con- length of the retort unless the ade- trolling instrument when combined quacy of another arrangement is docu- with a temperature/time recording de- mented by heat distribution data or vice. other documentation from a processing (4) Air valves. All air lines connected authority. Such information shall be to the retorts designed for pressure maintained on file by the establish- processing in steam shall be equipped ment and made available to Program with a globe valve or other equivalent- employees for review. type valve or piping arrangement that will prevent leakage of air into the re- (vi) Bleeders and condensate removal. tort during the process cycle. Bleeders, except those for external (5) Water valves. All retort water lines wells of temperature devices, shall 1 that are intended to be closed during a have ⁄8 inch (or 3 mm) or larger open- process cycle shall be equipped with a ings and shall be wide open during the globe valve or other equivalent-type entire process including the come-up valve or piping arrangement that will time. For horizontal still retorts, prevent leakage of water into the re- bleeders shall be located within ap- tort during the process cycle. proximately 1 foot (or 30 cm) of the (b) Pressure processing in steam—(1) outermost locations of containers at Batch still retorts. (i) The basic require- each end along the top of the retort. ments and recommendations for indi- Additional bleeders shall be located cating temperature devices and tem- not more than 8 feet (2.4 m) apart along perature/time recording devices are de- the top. Bleeders may be installed at scribed in paragraphs (a) (1) and (2) of positions other than those specified this section. Additionally, bulb sheaths above, as long as the establishment has or probes of indicating temperature de- heat distribution data or other docu- vices and probes of temperature/time mentation from the manufacturer or recording devices shall be installed ei- from a processing authority dem- ther within the retort shell or in exter- onstrating that the bleeders accom- nal wells attached to the retort. Exter- plish removal of air and circulate the nal wells shall be connected to the re- steam within the retort. This informa- tort through at least a 3⁄4 inch (1.9 cm) tion shall be maintained on file by the diameter opening and equipped with a establishment and made available to 1⁄16 inch (1.6 mm) or larger bleeder Program employees for review. All opening so located as to provide a con- bleeders shall be arranged in a way stant flow of steam past the length of that enables the retort operator to ob- the bulb or probe. The bleeder for ex- serve that they are functioning prop- ternal wells shall emit steam continu- erly. Vertical retorts shall have at ously during the entire thermal proc- least one bleeder opening located in essing period. the portion of the retort opposite the (ii) Steam controllers are required as steam inlet. All bleeders shall be ar- described in paragraph (a)(3) of this ranged so that the retort operator can section. observe that they are functioning prop- (iii) Steam inlet. The steam inlet to erly. In retorts having a steam inlet each retort shall be large enough to above the level of the lowest container,

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a bleeder shall be installed in the bot- do not impede the removal of air from tom of the retort to remove conden- the retort. Such documentation shall sate. The condensate bleeder shall be consist of either heat distribution data so arranged that the retort operator or documentation from the muffler can observe that it is functioning prop- manufacturer or from a processing au- erly. The condensate bleeder shall be thority. This information shall be checked with sufficient frequency to made available to Program employees ensure adequate removal of conden- for review. sate. Visual checks should be per- (ix) Vents. (a) Vents shall be located formed at intervals of not more than 15 in that portion of the retort opposite minutes and the results recorded. the steam inlet and shall be designed, Intermittent condensate removal sys- installed, and operated in such a way tems shall be equipped with an auto- that air is removed from the retort be- matic alarm system that will serve as fore timing of the thermal process is a continuous monitor of condensate started. Vents shall be controlled by a bleeder functioning. The automatic gate, plug cock, or other full-flow valve alarm system shall be tested at the be- which shall be fully opened to permit ginning of each shift for proper func- rapid removal of air from retorts dur- tioning and the results recorded. If the ing the venting period. alarm system is not functioning prop- (b) Vents shall not be connected to a erly, it must be repaired before the re- closed drain system without an atmos- tort is used. pheric break in the line. Where a retort (vii) Stacking equipment. (a) Equip- manifold connects several pipes from a ment for holding or stacking con- single retort, the manifold shall be tainers in retorts. Crates, trays, gondolas, carts, and other vehicles for controlled by a gate, plug cock, or holding or stacking product containers other full-flow valve and the manifold in the retort shall be so constructed to shall be of a size such that the cross- ensure steam circulation during the sectional area of the manifold is larger venting, come-up, and process times. than the total cross-sectional area of The bottom of each vehicle shall have all connecting vents. The discharge perforations at least 1 inch (2.5 cm) in shall not be connected to a closed drain diameter on 2 inch (or 5 cm) centers or without an atmospheric break in the the equivalent unless the adequacy of line. A manifold header connecting another arrangement is documented by vents or manifolds from several still heat distribution data or other docu- retorts shall lead to the atmosphere. mentation from a processing authority The manifold header shall not be con- and such information is maintained on trolled by a valve and shall be of a size file by the establishment and made such that the cross-sectional area is at available to Program employees for re- least equal to the total cross-sectional view. area of all connecting retort manifold (b) Divider plates. Whenever one or pipes from the maximum number of re- more divider plates are used between torts to be vented simultaneously. any two layers of containers or placed (c) Some typical installations and op- on the bottom of a retort vehicle, the erating procedures are described below. establishment shall have on file docu- Other retort installations, vent piping mentation that the venting procedure arrangements, operating procedures or allows the air to be removed from the auxiliary equipment such as divider retort before timing of the thermal plates may be used provided there is process is started. Such documentation documentation that the air is removed shall be in the form of heat distribu- from the retort before the process is tion data or documentation from a started. Such documentation shall be processing authority. This information in the form of heat distribution data or shall be made available to Program other documentation from the equip- employees for review. ment manufacturer or processing au- (viii) Bleeder and vent mufflers. If muf- thority. This information shall be flers are used on bleeders or vent sys- maintained on file by the establish- tems, the establishment shall have on ment and made available to Program file documentation that the mufflers employees for review.

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(d) For crateless retort installations, cm), and for retorts 15 feet (4.6 m) and over the establishment shall have heat dis- in length, 3 inches (7.6 cm). tribution data or other documentation Venting method (Figure 2): The manifold from the equipment manufacturer or vent gate, plug cock, or other full-flow valve shall be wide open for at least 6 minutes and from a processing authority that dem- ° ° onstrates that the venting procedure to at least 225 F (or 107 C) or for at least 8 minutes and to at least 220 °F (or 104.5 °C). used accomplishes the removal of air and condensate. This information shall (iii) Venting through water spreaders. be maintained on file by the establishment and made available to Program employees for review. (e) Examples of typical installations and operating procedures that comply with the requirements of this section are as follows: (1) Venting horizontal retorts. (i) Venting through multiple 1 inch (2.5 cm) vents discharging directly to the atmosphere.

Specifications (Figure 3): Size of vent and vent valve. For retorts less than 15 feet (4.6 m) in length, 2 inches (or 5 cm); for retorts 15 feet (4.6 m) and over in length, 21⁄2 inches (6.4 cm). Size of water spreader (Figure 3): For retorts less than 15 feet (4.6 m) in length, 11⁄2 inches (3.8 cm); for retorts 15 feet (4.6 m) and over in length 2 inches (or 5 cm). The number of holes shall be such that their total cross-sectional area is equal to the cross-sectional area of the vent pipe inlet. Specifications (Figure 1): One, 1-inch (2.5 cm) Venting method (Figure 3): The gate, plug vent for every 5 feet (1.5 m) of retort length, cock, or other full-flow valve on the water equipped with a gate, plug cock, or other spreader vent shall be wide open for at least full-flow valve and discharging to atmos- 5 minutes and to at least 225 °F (or 107 °C), or phere. The end vents shall not be more than for at least 7 minutes and to at least 220 °F 1 2 ⁄2 feet (or 75 cm) from ends of retort. (or 104.5 °C). Venting method (Figure 1): Vent valves shall be wide open for at least 5 minutes and to at (iv) Venting through a single 21⁄2 inch least 225 °F (or 107 °C), or at least 7 minutes (6.4 cm) top vent for retorts not exceed- and to at least 220 °F (or 104.5 °C). ing 15 feet (4.6 m) in length. (ii) Venting through multiple 1 inch (2.5 cm) vents discharging through a manifold to the atmosphere.

Specifications (Figure 4): A 21⁄2 inch (6.4 cm) vent equipped with a 21⁄2 inch (6.4 cm) gate, plug cock, or other full-flow valve and lo- Specifications (Figure 2): One, 1-inch (2.5 cm) cated within 2 feet (61 cm) of the center of vent for every 5 feet (1.5 m) of retort length; the retort. vents not over 21⁄2 feet (or 75 cm) from ends Venting method (Figure 4): The vent valve of retort; size of manifold for retorts less shall be wide open for at least 4 minutes and than 15 feet (4.6 m) in length, 21⁄2 inches (6.4 to at least 220 °F (or 104.5 °C).

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(2) Venting vertical retorts. Specifications (Figure 5): A 11⁄2 inch (3.8 cm) 1 (i) Venting through a 11⁄2 inch (3.8 cm) overflow pipe equipped with a 1 ⁄2 inch (3.8 overflow. cm) gate, plug cock, or other full-flow valve and with not more than 6 feet (1.8 m) of 11⁄2 inch (3.8 cm) pipe beyond the valve before a break to the atmosphere or to a manifold header. Venting method (Figure 5): The vent valve shall be wide open for at least 4 minutes and to at least 218 °F (or 103.5 °C), or for at least 5 minutes and to at least 215 °F (or 101.5 °C). (ii) Venting through a single 1 inch (2.5 cm) side or top vent.

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Specifications (Figure 6 or 7): A 1 inch (2.5 shall emit steam continuously during cm) vent in lid or top side, equipped with a the entire thermal processing period. gate, plug cock, or other full-flow valve and (ii) Steam controllers are required as discharging directly into the atmosphere or described in paragraph (a)(3) of this to a manifold header. section. Venting method (Figure 6 or 7): The vent valve shall be wide open for at least 5 min- (iii) Steam inlet. The steam inlet to utes and to at least 230 °F (110 °C), or for at each retort shall be large enough to least 7 minutes and to at least 220 °F (or 104.5 provide steam for proper operation of °C). the retort and shall enter at a point(s) to facilitate air removal during vent- (2) Batch agitating retorts. (i) The ing. basic requirements for indicating tem- (iv) Bleeders. Bleeders, except those perature devices and temperature/time for external wells of temperature de- recording devices are described in para- vices, shall be 1⁄8 inch (or 3 mm) or larg- graphs (a) (1) and (2) of this section. er and shall be wide open during the Additionally, bulb sheaths or probes of entire process including the come-up indicating temperature devices and time. Bleeders shall be located within probes of temperature/time recording approximately 1 foot (or 30 cm) of the devices shall be installed either within outermost location of containers, at the retort shell or in external wells at- each end along the top of the retort. tached to the retort. External wells Additional bleeders shall be located shall be connected to the retort not more than 8 feet (2.4 m) apart along through at least a 3⁄4 inch (1.9 cm) di- the top. Bleeders may be installed at ameter opening and equipped with a 1⁄16 positions other than those specified (1.6 mm) or larger bleeder opening so above, as long as the establishment has located as to provide a constant flow of heat distribution data or other docu- steam past the length of the bulbs or mentation from the manufacturer or probes. The bleeder for external wells from a processing authority that the

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bleeders accomplish removal of air and speed changes on retorts shall be pro- circulate the steam within the retort. vided. For example, a lock or a notice This information shall be maintained from management posted at or near on file by the establishment and made the speed adjustment device warning available to Program employees for re- that only authorized persons are per- view. All bleeders shall be arranged in mitted to make adjustments are satis- a way that enables the retort operator factory means of preventing unauthor- to observe that they are functioning ized changes. properly. (vii) Bleeder and vent mufflers. If muf- (v) Venting and condensate removal. flers are used on bleeders or vent sys- The air in the retort shall be removed tems, the establishment shall have doc- before processing is started. Heat dis- umentation that the mufflers do not tribution data or other documentation impede the removal of air from the re- from the manufacturer or from the tort. Such documentation shall consist processing authority who developed the of either heat distribution data or doc- venting procedure shall be kept on file umentation from the muffler manufac- by the establishment and made avail- turer or from a processing authority. able to Program employees for review. This information shall be maintained At the time the steam is turned on, the on file by the establishment and made drain shall be opened to remove steam available to Program employees for re- condensate from the retort. A bleeder view. shall be installed in the bottom of the (3) Continuous rotary retorts. (i) The retort to remove condensate during re- basic requirements for indicating tem- tort operation. The condensate bleeder perature devices and temperature/time shall be so arranged that the retort op- recording devices are described in para- erator can observe that it is func- graphs (a) (1) and (2) of this section. tioning properly. The condensate Additionally, bulb sheaths or probes of bleeder shall be checked with sufficient indicating temperature devices and frequency to ensure adequate removal probes of temperature/time recording of condensate. Visual checks should be devices shall be installed either within performed at intervals of not more the retort shell or in external wells at- than 15 minutes and the results re- tached to the retort. External wells corded. Intermittent condensate re- shall be connected to the retort moval systems shall be equipped with through at least a 3⁄4 inch (1.9 cm) dian automatic alarm system that will ameter opening and equipped with a 1⁄16 serve as a continuous monitor of con- inch (1.6 mm) or larger bleeder opening densate bleeder functioning. The auto- so located as to provide a constant flow matic alarm system shall be tested at of steam past the length of the bulbs or the beginning of each shift for proper probes. The bleeder for external wells functioning and the results recorded. If shall emit steam continuously during the alarm system is not functioning the entire thermal processing period. properly, it must be repaired before the (ii) Steam controllers are required as retort is used. described in paragraph (a)(3) of this (vi) Retort or reel speed timing. The re- section. tort or reel speed shall be checked be- (iii) Steam inlet. The steam inlet to fore process timing begins and, if need- each retort shall be large enough to ed, adjusted as specified in the process provide steam for proper operation of schedule. In addition, the rotational the retort, and shall enter at a point(s) speed shall be determined and recorded to facilitate air removal during vent- at least once during process timing of ing. each retort load processed. Alter- (iv) Bleeders. Bleeders, except those natively, a recording tachometer can for external wells of temperature de- be used to provide a continuous record vices, shall be 1⁄8 inch (3.2 mm) or larg- of the speed. The accuracy of the re- er and shall be wide open during the cording tachometer shall be deter- entire process, including the come-up mined and recorded at least once per time. Bleeders shall be located within shift by checking the retort or reel approximately 1 foot (or 30 cm) of the speed using an accurate stopwatch. A outermost location of containers at means of preventing unauthorized each end along the top of the retort.

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Additional bleeders shall be located speed is maintained. Alternatively, a not more than 8 feet (2.4 m) apart along recording tachometer may be used to the top of the retort. Bleeders may be provide a continuous record of the installed at positions other than those speed. If a recording tachometer is specified above, as long as the estab- used, the speed shall be manually lishment has heat distribution data or checked against an accurate stopwatch other documentation from the manu- at least once per shift and the results facturer or a processing authority that recorded. A means of preventing unau- the bleeders accomplish removal of air thorized speed changes on retorts shall and circulate the steam within the re- be provided. For example, a lock or a tort. This information shall be main- notice from management posted at or tained on file by the establishment and near the speed adjustment device warn- made available to Program employees ing that only authorized persons are for review. All bleeders shall be ar- permitted to make adjustments are ranged so that the retort operator can satisfactory means of preventing unau- observe that they are functioning prop- thorized changes. erly. (vii) Bleeders and vent mufflers. If muf- (v) Venting and condensate removal. flers are used on bleeders or vent sys- The air in the retort shall be removed tems, the establishment shall have doc- before processing is started. Heat dis- umentation that the mufflers do not tribution data or other documentation impede the removal of air from the re- from the manufacturer or from the tort. Such documentation shall consist processing authority who developed the of either heat distribution data or venting procedure shall be kept on file other documentation from the muffler by the establishment and made avail- manufacturer or from a processing au- able to Program employees for review. thority. This information shall be At the time the steam is turned on, the maintained on file by the establish- drain shall be opened to remove steam ment and made available to Program condensate from the retort. A bleeder employees for review. shall be installed in the bottom of the (4) Hydrostatic retorts. (i) The basic re- shell to remove condensate during the quirements for indicating temperature retort operation. The condensate bleed- devices and temperature/time recorder shall be so arranged that the retort ing devices are described in paragraphs operator can observe that it is func- (a) (1) and (2) of this section. Addition- tioning properly. The condensate ally, indicating temperature devices bleeder shall be checked with sufficient shall be located in the steam dome frequency to ensure adequate removal near the steam/water interface. Where of condensate. Visual checks should be the process schedule specifies mainte- performed at intervals of not more nance of particular water temperatures than 15 minutes and the results rein the hydrostatic water legs, at least corded. Intermittent condensate re- one indicating temperature device moval systems shall be equipped with shall be located in each hydrostatic an automatic alarm system that will water leg so that it can accurately serve as a continuous monitor of con- measure water temperature and be eas- densate bleeder functioning. The auto- ily read. The temperature/time re- matic alarm system shall be tested at corder probe shall be installed either the beginning of each shift for proper within the steam dome or in a well at- functioning and the results recorded. If tached to the dome. Each probe shall the alarm system is not functioning have a 1⁄16 inch (1.6 mm) or larger bleed- properly, it must be repaired before the er opening which emits steam continu- retort is used. ously during the processing period. Ad- (vi) Retort speed timing. The rota- ditional temperature/time recorder tional speed of the retort shall be spec- probes shall be installed in the hydro- ified in the process schedule. The speed static water legs if the process sched- shall be adjusted as specified, and re- ule specifies maintenance of particular corded by the establishment when the temperatures in these water legs. retort is started, and checked and re- (ii) Steam controllers are required as corded at intervals not to exceed 4 described in paragraph (a)(3) of this hours to ensure that the correct retort section.

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(iii) Steam inlet. The steam inlets ment and made available to Program shall be large enough to provide steam employees for review. for proper operation of the retort. (c) Pressure processing in water—(1) (iv) Bleeders. Bleeder openings 1⁄4 inch Batch still retorts. (i) The basic require- (or 6 mm) or larger shall be located in ments for indicating temperature de- the steam chamber(s) opposite the vices and temperature/time recording point of steam entry. Bleeders shall be devices are described in paragraphs wide open and shall emit steam con- (a)(1) and (2) of this section. Addition- tinuously during the entire process, in- ally, bulbs or probes of indicating tem- cluding the come-up time. All bleeders perature devices shall be located in shall be arranged in such a way that such a position that they are beneath the operator can observe that they are the surface of the water throughout functioning properly. the process. On horizontal retorts, the (v) Venting. Before the start of proc- indicating temperature device bulb or essing operations, the retort steam probe shall be inserted directly into chamber(s) shall be vented to ensure the retort shell. In both vertical and removal of air. Heat distribution data horizontal retorts, the indicating tem- or other documentation from the man- perature device bulb or probe shall ex- ufacturer or from a processing author- tend directly into the water a min- ity demonstrating that the air is re- imum of 2 inches (or 5 cm) without a moved from the retort prior to proc- separable well or sleeve. In vertical re- essing shall be kept on file at the es- torts equipped with a recorder/controller, the controller probe shall be lo- tablishment and made available to cated at the bottom of the retort below Program employees for review. the lowest crate rest in such a position (vi) The conveyor Conveyor speed. that the steam does not strike it di- speed shall be calculated to obtain the rectly. In horizontal retorts so required process time and recorded by equipped, the controller probe shall be the establishment when the retort is located between the water surface and started. The speed shall be checked and the horizontal plane passing through recorded at intervals not to exceed 4 the center of the retort so that there is hours to ensure that the correct con- no opportunity for direct steam im- veyor speed is maintained. A recording pingement on the controller probe. Air- device may be used to provide a contin- operated temperature controllers shall uous record of the conveyor speed. have filter systems to ensure a supply When a recording device is used, the of clean, dry air. speed shall be manually checked (ii) Pressure recording device. Each re- against an accurate stopwatch at least tort shall be equipped with a pressure once per shift by the establishment. A recording device which may be com- means of preventing unauthorized bined with a pressure controller. speed changes of the conveyor shall be (iii) Steam controllers are required provided. For example, a lock or a no- as described in paragraph (a)(3) of this tice from management posted at or section. near the speed adjustment device warn- (iv) Heat distribution. Heat distribu- ing that only authorized persons are tion data or other documentation from permitted to make adjustments are the equipment manufacturer or a proc- satisfactory means of preventing unau- essing authority demonstrating uni- thorized changes. form heat distribution within the re- (vii) Bleeders and vent mufflers. If muf- tort shall be kept on file at the estab- flers are used on bleeders or vent sys- lishment and made available to Pro- tems, the establishment shall have doc- gram employees for review. umentation that the mufflers do not (v) Crate supports. A bottom crate impede the removal of air from the re- support shall be used in vertical retort. Such documentation shall consist torts. Baffle plates shall not be used in of either heat distribution data or the bottom of the retort. other documentation from the muffler (vi) Stacking equipment. For filled manufacturer or from a processing au- flexible containers and, where applica- thority. This information shall be ble, semirigid containers, stacking maintained on file by the establish- equipment shall be designed to ensure

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that the thickness of the filled con- be maintained on file by the establish- tainers does not exceed that specified ment and made available to Program in the process schedule and that the employees for review. containers do not become displaced and (x) Water recirculation. When a water overlap or rest on one another during recirculation system is used for heat the thermal process. distribution, the water shall be drawn (vii) Drain valve. A nonclogging, from the bottom of the retort through water-tight drain valve shall be used. a suction manifold and discharged Screens shall be installed over all drain through a spreader that extends the openings. length or circumference of the top of (viii) Water level. There shall be a the retort. The holes in the water means of determining the water level spreader shall be uniformly distrib- in the retort during operation (i.e., by uted. The suction outlets shall be pro- using a gauge, electronic sensor, or tected with screens to keep debris from sight glass indicator). For retorts re- entering the recirculation system. The quiring complete immersion of containers, water shall cover the top layer pump shall be equipped with a pilot of containers during the entire come- light or a similar device to warn the up time and thermal processing periods operator when it is not running, and and should cover the top layer of con- with a bleeder to remove air when tainers during cooling. For retorts starting operations. Alternatively, a using cascading water or water sprays, flow-meter alarm system can be used the water level shall be maintained to ensure proper water circulation. The within the range specified by the retort adequacy of water circulation for manufacturer or processing authority maintaining uniform heat distribution during the entire come-up, thermal within the retort shall be documented processing, and cooling periods. A by heat distribution data or other doc- means to ensure that water circulation umentation from a processing author- continues as specified throughout the ity and such data shall be maintained come-up, thermal processing, and cool- on file by the establishment and made ing periods shall be provided. The re- available to Program employees for retort operator shall check and record view. Alternative methods for recir- the water level at intervals to ensure it culation of water in the retort may be meets the specified processing param- used, provided there is documentation eters. in the form of heat distribution data or (ix) Air supply and controls. In both other documentation from a processing horizontal and vertical still retorts, a authority maintained on file by the es- means shall be provided for introducing tablishment and made available to compressed air or steam at the pres- Program employees for review. sure required to maintain container in- (xi) Cooling water entry. In retorts for tegrity. Compressed air and steam processing product packed in glass jars, entry shall be controlled by an auto- the incoming cooling water should not matic pressure control unit. A non- directly strike the jars, in order to return valve shall be provided in the minimize glass breakage by thermal air supply line to prevent water from shock. entering the system. Overriding air or steam pressure shall be maintained (2) Batch agitating retorts. (i) The continuously during the come-up, ther- basic requirements and recommenda- mal processing, and cooling periods. If tions for indicating temperature de- air is used to promote circulation, it vices and temperture/time recording shall be introduced into the steam line devices are described in paragraphs (a) at a point between the retort and the (1) and (2) of this section. Additionally, steam control valve at the bottom of the indicating temperature device bulb the retort. The adequacy of the air cir- or probe shall extend directly into the culation for maintaining uniform heat water without a separable well or distribution within the retort shall be sleeve. The recorder/controller probe documented by heat distribution data shall be located between the water sur- or other documentation from a proc- face and the horizontal plane passing essing authority, and such data shall through the center of the retort so that

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there is no opportunity for steam to di- tort and the steam control valve at the rectly strike the controller bulb or bottom of the retort. The adequacy of probe. the air circulation for maintaining uni- (ii) Pressure recording device. Each reform heat distribution within the retort shall be equipped with a pressure tort shall be documented by heat dis- recording device which may be com- tribution data or other documentation bined with a pressure controller. from a processing authority, and such (iii) Steam controllers are required as data shall be maintained on file by the described in paragraph (a)(3) of this establishment and made available to section. Program employees for review. (iv) Heat distribution. Heat distribu- (ix) Retort or reel speed timing. The re- tion data or other documentation from tort or reel speed timing shall be the equipment manufacturer or a proc- checked before process timing begins essing authority shall be kept on file and, if needed, adjusted as specified in by the establishment and made avail- the process schedule. In addition, the able to Program employees for review. rotational speed shall be determined (v) Stacking equipment. All devices and recorded at least once during proc- used for holding product containers ess timing of each retort load proc- (e.g., crates, trays, divider plates) shall essed. Alternatively, a recording ta- be so constructed to allow the water to chometer can be used to provide a con- circulate around the containers during tinuous record of the speed. The accu- the come-up and thermal process peri- racy of the recording tachometer shall ods. be determined and recorded at least (vi) Drain valve. A nonclogging, once per shift by the establishment by water-tight drain valve shall be used. checking the retort or reel speed using Screens shall be installed over all drain an accurate stopwatch. A means of pre- openings. venting unauthorized speed changes on (vii) Water level. There shall be a retorts shall be provided. For example, means of determining the water level a lock or a notice from management in the retort during operation (i.e., by posted at or near the speed adjustment using a gauge, electronic sensor, or device warning that only authorized sight glass indicator). Water shall com- persons are permitted to make adjust- pletely cover all containers during the ments are satisfactory means of pre- entire come-up, thermal processing, venting unauthorized changes. and cooling periods. A means to ensure (x) Water recirculation. If a water re- that water circulation continues as circulation system is used for heat dis- specified throughout the come-up, tribution, it shall be installed in such a thermal processing, and cooling periods manner that water will be drawn from shall be provided. The retort operator the bottom of the retort through a suc- shall check and record the adequacy of tion manifold and discharged through a the water level with sufficient fre- spreader which extends the length of quency to ensure it meets the specified the top of the retort. The holes in the processing parameters. water spreader shall be uniformly dis- (viii) Air supply and controls. Retorts tributed. The suction outlets shall be shall be provided with a means for in- protected with screens to keep debris troducing compressed air or steam at from entering the recirculation sys- the pressure required to maintain con- tem. The pump shall be equipped with tainer integrity. Compressed air and a pilot light or a similar device to warn steam entry shall be controlled by an the operator when it is not running and automatic pressure control unit. A with a bleeder to remove air when nonreturn valve shall be provided in starting operations. Alternatively, a the air supply line to prevent water flow-meter alarm system can be used from entering the system. Overriding to ensure proper water circulation. The air or steam pressure shall be main- adequacy of water circulation for tained continuously during the come- maintaining uniform heat distribution up, thermal processing, and cooling pe- within the retort shall be documented riods. If air is used to promote circula- by heat distribution data or other doc- tion, it shall be introduced into the umentation from a processing author- steam line at a point between the re- ity and such data shall be maintained

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on file by the establishment and made pheric cooker (e.g., hot water bath) available to Program employees for re- shall be equipped with at least one view. Alternative methods for recir- temperature/time recording device in culation of water in the retort may be accordance with the basic require- used provided there is documentation ments described in paragraph (a)(2) of in the form of heat distribution data or this section. other documentation from a processing (2) Heat distribution. Each atmos- authority maintained on file by the es- pheric cooker shall be equipped and op- tablishment and made available to erated to ensure uniform heat distribu- Program employees for review. tion throughout the processing system (xi) Cooling water entry. In retorts for during the thermal process. Heat dis- processing product packed in glass jars, tribution data or other documentation the incoming cooling water should not from the manufacturer or a processing directly strike the jars, in order to authority demonstrating uniform heat minimize glass breakage by thermal distribution within the cooker shall be shock. kept on file by the establishment and (d) Pressure processing with steam/air made available to Program employees mixtures in batch retorts. (1) The basic for review. requirements for indicating tempera- (f) Other systems. All other systems ture devices and temperature/time re- not specifically delineated in this sec- cording devices are described in para- tion and used for the thermal proc- graphs (a) (1) and (2) of this section. essing of canned product shall be ade- Additionally, bulb sheaths or probes quate to produce shelf-stable products for indicating temperature devices and consistently and uniformly. temperature/time recording devices or (g) Equipment maintenance. (1) Upon controller probes shall be inserted di- installation, all instrumentation and rectly into the retort shell in such a controls shall be checked by the estab- position that steam does not strike lishment for proper functioning and ac- them directly. curacy and, thereafter, at any time (2) Steam controllers are required as their functioning or accuracy is sus- described in paragraph (a)(3) of this pect. section. (2) At least once a year each thermal (3) Recording pressure controller. A reprocessing system shall be examined by cording pressure controller shall be an individual not directly involved in used to control the air inlet and the daily operations to ensure the proper steam/air mixture outlet. functioning of the system as well as all (4) Circulation of steam/air mixture. A auxiliary equipment and instrumenta- means shall be provided for the circulation. In addition, each thermal proc- tion of the steam/air mixture to pre- essing system should be examined be- vent formation of low-temperature fore the resumption of operation fol- pockets. The efficiency of the circula- lowing an extended shutdown. tion system shall be documented by (3) Air and water valves that are in- heat distribution data or other docu- tended to be closed during thermal mentation from a processing authority, processing shall be checked by the es- and such data shall be maintained on tablishment for leaks. Defective valves file by the establishment and made shall be repaired or replaced as needed. available to Program employees for re- (4) Vent and bleeder mufflers shall be view. The circulation system shall be checked and maintained or replaced by checked to ensure its proper func- the establishment to prevent any re- tioning and shall be equipped with a duction in vent or bleeder efficiency. pilot light or a similar device to warn (5) When water spreaders are used for the operator when it is not func- venting, a maintenance schedule shall tioning. Because of the variety of exist- be developed and implemented to as- ing designs, reference shall be made to sure that the holes are maintained at the equipment manufacturer for de- their original size. tails of installation, operation and con- (6) Records shall be kept on all main- trol. tenance items that could affect the (e) Atmospheric cookers—(1) Tempera- adequacy of the thermal process. ture/time recording device. Each atmos- Records shall include the date and type

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of maintenance performed and the per- seal area, containers should not remain son conducting the maintenance. stationary on moving conveyors. All (h) Container cooling and cooling post-process container handling equip- water. (1) Potable water shall be used ment should be kept clean so there is for cooling except as provided for in no buildup of microorganisms on sur- paragraphs (h) (2) and (3) of this sec- faces in contact with the containers. tion. (Approved by the Office of Management and (2) Cooling canal water shall be Budget under control number 0583–0015) chlorinated or treated with a chemical approved by the Administrator as hav- [51 FR 45634, Dec. 19, 1986, as amended at 65 FR 34390, May 30, 2000] ing a bactericidal effect equivalent to chlorination. There shall be a measur- § 381.306 Processing and production able residual of the sanitizer in the records. water at the discharge point of the At least the following processing and canal. Cooling canals shall be cleaned production information shall be re- and replenished with potable water to corded by the establishment: Date of prevent the buildup of organic matter production; product name and style; and other materials. container code; container size and (3) Container cooling waters that are type; and the process schedule, includ- recycled or reused shall be handled in ing the minimum initial temperature. systems that are so designed, operated, Measurements made to satisfy the re- and maintained so there is no buildup quirements of § 381.303 regarding the of microorganisms, organic matter, control of critical factors shall be re- and other materials in the systems and corded. In addition, where applicable, in the waters. System equipment, such the following information and data as pipelines, holding tanks and cooling shall also be recorded: towers, shall be constructed and in- (a) Processing in steam—(1) Batch still stalled so that they can be cleaned and retorts. For each retort batch, record inspected. In addition, the establish- the retort number or other designa- ment shall maintain, and make avail- tion, the approximate number of con- able to Program employees for review, tainers or the number of retort crates information on at least the following: per retort load, product initial tem- (i) System design and construction; perature, time steam on, the time and (ii) System operation including the temperature vent closed, the start of rates of renewal with fresh, potable process timing, time steam off, and the water and the means for treating the actual processing time. The indicating water so that there is a measurable re- temperature device and the tempera- sidual of an acceptable sanitizer, per ture recorder shall be read at the same paragraph (h)(2) of this section, in the time at least once during process tim- water at the point where the water ing and the observed temperatures re- exits the container cooling vessel; corded. (iii) System maintenance including (2) Batch agitating retorts. In addition procedures for the periodic cleaning to recording the information required and sanitizing of the entire system; for batch, still steam retorts in para- and graph (a)(1) of this section, record the (iv) Water quality standards, such as functioning of the condensate bleed- microbiological, chemical and phys- er(s) and the retort or reel speed. ical, monitoring procedures including (3) Continuous rotary retorts. Record the frequency and site(s) of sampling, the retort system number, the approxi- and the corrective actions taken when mate total number of containers re- water quality standards are not met. torted, product initial temperature, (i) Post-process handling of containers. time steam on, the time and tempera- Containers shall be handled in a man- ture vent closed, time process tempera- ner that will prevent damage to the ture reached, the time the first can en- hermetic seal area. All worn and frayed ters and the time the last can exits the belting, can retarders, cushions, and retort. The retort or reel speed shall be the like shall be replaced with non- determined and recorded at intervals porous materials. To minimize con- not to exceed 4 hours. Readings of the tainer abrasions, particularly in the indicating temperature device(s) and

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temperature recorder(s) shall be made process timing and the observed tem- and recorded at the time the first con- peratures recorded. tainer enters the retort and thereafter (2) Batch agitating retorts. In addition with sufficient frequency to ensure to recording the information required compliance with the process schedule. in paragraph (b)(1) of this section, These observations should be made and record the retort or reel speed. recorded at intervals not exceeding 30 (c) Processing in steam/air mixtures. minutes of continuous retort oper- For each retort batch, record the re- ation. Functioning of the condensate tort number or other designation, the bleeder(s) shall be observed and re- approximate number of containers or corded at the time the first container number of retort crates per retort load, enters the retort and thereafter as product initial temperature, time specified in § 381.305(b)(3)(v). steam on, venting procedure, if applicable, the start of process timing, (4) Hydrostatic retorts. Record the re- maintenance of circulation of the tort system number, the approximate steam/air mixture, air flow rate or total number of containers retorted, forced recirculation flow rate (if crit- product initial temperature, time ical), overriding pressure maintained, steam on, the time and temperature time steam off, and actual processing vent(s) closed, time process tempera- time. The indicating temperature de- ture reached, time first containers vice and the temperature recorder shall enter the retort, time last containers be read at the same time at least once exit the retort, and, if specified in the during process timing and the observed process schedule, measurements of temperatures recorded. temperatures in the hydrostatic water (d) Atmospheric cookers—(1) Batch-type legs. Readings of the temperature indi- systems. For each cooker batch, record cating device, which is located in the the cooker number or other designa- steam/water interface, and the tem- tion and the approximate number of perature recording device shall be ob- containers. In addition, record all crit- served and the temperatures recorded ical factors of the process schedule at the time the first containers enter such as cooker temperature, initial the steam dome. Thereafter, these in- temperature, the time the thermal struments shall be read and the tem- process cycle begins and ends, hold peratures recorded with sufficient fre- time, and the final internal product quency to ensure compliance with the temperature. temperature specified in the process (2) Continuous-type systems. Record schedule and should be made at least the cooker number or other designa- every hour of continuous retort oper- tion, the time the first containers ation. Container conveyor speed, and enter and the last containers exit a for agitating hydrostatic retorts, the cooker, and the approximate total rotative chain speed, shall be deter- number of containers processed. In ad- mined and recorded at intervals of suf- dition, record all critical factors of the ficient frequency to ensure compliance process schedule such as the initial with the process schedule and should temperature, cooker speed, and final be performed at least every 4 hours. internal product temperature. (b) Processing in water—(1) Batch still (Approved by the Office of Management and retorts. For each retort batch, record Budget under control number 0583–0015) the retort number or other designation, the approximate number of con- § 381.307 Record review and mainte- tainers or number of retort crates per nance. retort load, product initial tempera- (a) Process records. Charts from tem- ture, time steam on, the start of proc- perature/time recording devices shall ess timing, water level, water recir- be identified by production date, con- culation rate (if critical), overriding tainer code, processing vessel number pressure maintained, time steam off, or other designation and other data as and actual processing time. The indi- necessary to enable correlation with cating temperature device and the the records required in § 381.306. Each temperature recorder shall be read at entry on a record shall be made at the the same time at least once during time the specific event occurs, and the

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recording individual shall sign or ini- available to Program employees within tial each record form. No later than 1 3 working days. working day after the actual process, (Approved by the Office of Management and the establishment shall review all Budget under control number 0583–0015) processing and production records to ensure completeness and to determine [51 FR 45634, Dec. 19, 1986, as amended at 65 FR 34390, May 30, 2000] if all product received the process schedule. All records, including the § 381.308 Deviations in processing. temperature/time recorder charts and critical factor control records, shall be (a) Whenever the actual process is signed or initialed and dated by the less than the process schedule or when any critical factor does not comply person conducting the review. All proc- with the requirements for that factor essing and production records required as specified in the process schedule, it in this subpart shall be made available shall be considered a deviation in proc- to Program employees for review. essing. (b) Automated process monitoring and (b) Deviations in processing (or proc- recordkeeping. Automated process mon- ess deviations) must be handled accord- itoring and recordkeeping systems ing to: shall be designed and operated in a (1)(i) A HACCP plan for canned prod- manner which will ensure compliance uct that addresses hazards associated with the applicable requirements of with microbial contamination, or, § 381.306. (ii) Alternative documented proce- (c) Container closure records. Written dures that will ensure that only safe records of all container closure exami- and stable product is shipped in com- nations shall specify the container merce; or code, the date and time of container (iii) Paragraph (d) of this section. closure examination, the measure- (2) Paragraph (d) of this section. ment(s) obtained, and any corrective (c) [Reserved] actions taken. Records shall be signed (d) Procedures for handling process or initialed by the container closure deviations where the HACCP plan for technician and shall be reviewed and thermally processed/commercially signed by the establishment within 1 sterile product does not address food working day after the actual produc- safety hazards associated with micro- tion to ensure that the records are bial contamination, where there is no complete and that the closing oper- approved total quality control system, ations have been properly controlled. or where the establishment has no al- All container closure examination ternative documented procedures for records required in this subpart shall handling process deviations. be made available to Program employ- (1) Deviations identified in-process. If a ees for review. deviation is noted at any time before (d) Distribution of product. Records the completion of the intended process shall be maintained by the establish- schedule, the establishment shall: ment identifying initial distribution of (i) Immediately reprocess the prod- the finished product to facilitate, if uct using the full process schedule; or, necessary, the segregation of specific (ii) Use an appropriate alternate production lots that may have been process schedule provided such a proc- contaminated or are otherwise unsound ess schedule has been established in ac- for their intended use. cordance with § 381.302 (a) and (b) and is (e) Retention of records. Copies of all filed with the inspector in accordance processing and production records re- with § 381.302(c); or, quired in § 381.306 shall be retained for (iii) Hold the product involved and no less than 1 year at the establish- have the deviation evaluated by a processing authority to assess the safety ment, and for an additional 2 years at and stability of the product. Upon com- the establishment or other location pletion of the evaluation, the establish- from which the records can be made ment shall provide the inspector the following:

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(a) A complete description of the de- ule, the reel shall be stopped and the viation along with all necessary sup- following actions shall be taken: porting documentation; (1) For temperature drops of less (b) A copy of the evaluation report; than 10 °F (or 5.5 °C) either (i) all con- and, tainers in the retort shall be given an (c) A description of any product dis- emergency still process (developed per position actions, either taken or pro- § 381.302(b)) before the reel is restarted; posed. (ii) container entry to the retort shall (iv) Product handled in accordance be prevented and an emergency agi- with paragraph (d)(1)(iii) of this section tating process (developed per shall not be shipped from the establish- § 381.302(b)) shall be used before con- ment until the Program has reviewed tainer entry to the retort is restarted; all of the information submitted and or (iii) container entry to the retort approved the product disposition ac- shall be prevented and the reel re- tions. started to empty the retort. The dis- (v) If an alternate process schedule is charged containers shall be reproc- used that is not on file with the inspec- essed, repacked and reprocessed, or de- tor or if an alternate process schedule stroyed. Product to be destroyed shall is immediately calculated and used, be handled as ‘‘U.S. Inspected and Con- the product shall be set aside for fur- demned’’, as defined in § 301.2(ee) of this ther evaluation in accordance with chapter, and disposed of in accordance paragraphs (d)(1) (iii) and (iv) of this with part 314 of this chapter. section. (2) For temperature drops of 10 °F (or (vi) When a deviation occurs in a con- 5.5 °C) or more, all containers in the re- tinuous rotary retort, the product shall tort shall be given an emergency still be handled in accordance with para- process (developed per § 381.302(b)). The graphs (d)(1) (iii) and (iv) of this sec- time the reel was stopped and the time tion or in accordance with the fol- the retort was used for a still retort lowing procedures: process shall be marked on the tem- (a) Emergency stops. perature/time recording device by the (1) When retort jams or breakdowns establishment and entered on the other occur during the processing operations, production records required in § 381.306. all containers shall be given an emer- Alternatively, container entry to the gency still process (developed per retort shall be prevented and the reel § 381.302(b)) before the retort is cooled restarted to empty the retort. The dis- or the retort shall be cooled promptly charged containers shall be either re- and all containers removed and either processed, repacked and reprocessed, or reprocessed, repacked and reprocessed, destroyed. Product to be destroyed or destroyed. Regardless of the proce- shall be handled as ‘‘U.S. Inspected and dure used, containers in the retort in- Condemned’’ as defined in § 301.2(ee) of take valve and in transfer valves be- this chapter, and disposed of in accord- tween retort shells at the time of a jam ance with part 314 of this chapter. or breakdown shall be removed and ei- (2) Deviations identified through record ther reprocessed, repacked and reproc- review. Whenever a deviation is noted essed, or destroyed. Product to be de- during review of the processing and stroyed shall be handled as ‘‘U.S. In- production records required by § 381.307 spected and Condemned’’, as defined in (a) and (b), the establishment shall § 301.2(ee) of this chapter, and disposed hold the product involved and the devi- of in accordance with part 314 of this ation shall be handled in accordance chapter. with paragraphs (d)(1) (iii) and (iv) of (2) The time the retort reel stopped this section. and the time the retort is used for an (e) Process deviation file. The estab- emergency still retort process shall be lishment shall maintain full records re- noted on the temperature/time record- garding the handling of each deviation. ing device and entered on the other Such records shall include, at a min- production records required in § 381.306. imum, the appropriate processing and (b) Temperature drops. When the reproduction records, a full description of tort temperature drops below the tem- the corrective actions taken, the eval- perature specified in the process sched- uation procedures and results, and the

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disposition of the affected product. time the sample containers were held Such records shall be maintained in a at the deviant temperature. If the incu- separate file or in a log that contains bation temperature is at or above 103 the appropriate information. The file °F (or 39.5 °C) for more than 2 hours, or log shall be retained in accordance the incubation test(s) shall be termi- with § 381.307(e) and shall be made nated, the temperature lowered to available to Program employees upon within the required range, and new request. sample containers incubated for the re- (Approved by the Office of Management and quired time. Budget under control number 0583–0015) (iii) Product requiring incubation. Shelf stable product requiring incuba- [51 FR 45634, Dec. 19, 1986, as amended at 62 tion includes: FR 45027, Aug. 25, 1997; 65 FR 34390, May 30, 2000; 65 FR 53533, Sept. 5, 2000] (a) Low acid products as defined in § 381.300(m); and § 381.309 Finished product inspection. (b) Acidified low acid products as de- (a) Finished product inspections fined in § 381.300(b). must be handled according to: (iv) Incubation samples. (a) From each (1) A HACCP plan for canned product load of product processed in a batch- that addresses hazards associated with type thermal processing system (still microbiological contamination; or or agitation), the establishment shall (2) An FSIS-approved total quality select at least one container for incu- control system; or bation. (3) Alternative documented proce- (b) For continuous rotary retorts, hy- dures that will ensure that only prod- drostatic retorts, or other continuous- uct that is safe and stable is shipped in type thermal processing systems, the commerce; or establishment shall select at least one (4) Paragraph (d) of this section. container per 1,000 for incubation. (b)–(c) [Reserved] (c) Only normal-appearing containers (d) Procedures for finished product shall be selected for incubation. inspections where the HACCP plan for (v) Incubation time. Canned product thermally processed/commercially requiring incubation shall be incubated sterile product does not address food for not less than 10 days (240 hours) safety hazards associated with micro- under the conditions specified in para- bial contamination, where there is no graph (d)(1)(ii) of this section. approved total quality control system, (vi) Incubation checks and record main- or where the establishment has no al- tenance. Designated establishment em- ternative documented procedures for ployees shall visually check all con- handling process deviations. tainers under incubation each working (1) Incubation of shelf stable canned day and the inspector shall be notified product—(i) Incubator. The establish- when abnormal containers are de- ment shall provide incubation facilities tected. All abnormal containers should which include an accurate tempera- be allowed to cool before a final deci- ture/time recording device, an indi- sion on their condition is made. For cating temperature device, a means for each incubation test the establishment the circulation of the air inside the in- shall record at least the product name, cubator to prevent temperature vari- container size, container code, number ations, and a means to prevent unau- of containers incubated, in and out thorized entry into the facility. The dates, and incubation results. The es- Program is responsible for the security tablishment shall retain such records, of the incubator. along with copies of the temperature/ (ii) Incubation temperature. The incu- time recording charts, in accordance bation temperature shall be main- with § 381.307(e). tained at 95±5 °F (35±2.8 °C). If the incu- (vii) Abnormal containers. The finding bation temperature falls below 90 °F (or of abnormal containers (as defined in 32 °C) or exceeds 100 °F (or 38 °C) but § 381.300(a)) among incubation samples does not reach 103 °F (or 39.5 °C), the is cause to officially retain at least the incubation temperature shall be ad- code lot involved. justed within the required range and (viii) Shipping. No product shall be the incubation time extended for the shipped from the establishment before

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the end of the required incubation pe- § 381.311 Recall procedure. riod except as provided in this para- Establishments shall prepare and graph or paragraph (b) or (c) of this maintain a current procedure for the section. An establishment wishing to recall of all canned product covered by ship product prior to the completion of this subpart. Upon request, the recall the required incubation period shall procedure shall be made available to submit a written proposal to the area Program employees for review. supervisor. Such a proposal shall include provisions that will assure that (Approved by the Office of Management and shipped product will not reach the re- Budget under control number 0583–0015) tail level of distribution before sample incubation is completed and that prod- Subpart Y—Nutrition Labeling uct can be returned promptly to the establishment should such action be SOURCE: 58 FR 675, Jan. 6, 1993, unless oth- deemed necessary by the incubation erwise noted. test results. Upon receipt of written approval from the area supervisor, § 381.400 Nutrition labeling of poultry product may be routinely shipped pro- products. vided the establishment continues to (a) Nutrition labeling shall be pro- comply with all requirements of this vided for all poultry products intended subpart. for human consumption and offered for (2) Container condition. (i) Normal con- sale, except single-ingredient, raw tainers. Only normal-appearing con- products, in accordance with the re- tainers shall be shipped from an estab- quirements of § 381.409, except as ex- lishment as determined by an appro- empted under § 381.500 of this subpart. priate sampling plan or other means (b) Nutrition labeling may be pro- acceptable to Program employees. vided for single-ingredient, raw poultry (ii) Abnormal containers. When abnor- products in accordance with the re- mal containers are detected by any quirements of §§ 381.409 and 381.445. Sig- means other than incubation, the es- nificant participation in voluntary nu- tablishment shall inform the inspector trition labeling shall be measured by and the affected code lot(s) shall not be the Agency in accordance with shipped until the Program has deter- §§ 381.443 and 381.444 of this subpart. mined that the product is safe and stable. Such a determination will take [58 FR 675, Jan. 6, 1993, as amended at 60 FR 197, Jan. 3, 1995] into account the cause and level of abnormals in the affected lot(s) as well EFFECTIVE DATE NOTE: At 75 FR 82166, Dec. as any product disposition actions ei- 29, 2010, § 381.400 was revised, effective Jan. 1, ther taken or proposed by the estab- 2012. At 76 FR 76890, Dec. 9, 2011, the effectiveness was delayed until Mar. 1, 2012. For lishment. the convenience of the user, the revised text (Approved by the Office of Management and is set forth as follows: Budget under control number 0583–0015) § 381.400 Nutrition labeling of poultry prod- [51 FR 45634, Dec. 19, 1986, as amended at 57 ucts. FR 37872, Aug. 21, 1992; 57 FR 55443, Nov. 25, (a) Nutrition labeling must be provided for 1992; 62 FR 45027, Aug. 25, 1997; 65 FR 34391, all poultry products intended for human con- May 30, 2000; 65 FR 53533, Sept. 5, 2000] sumption and offered for sale, except single- ingredient, raw poultry products that are § 381.310 Personnel and training. not ground or chopped poultry products de- All operators of thermal processing scribed in § 381.401 and are not major cuts of systems specified in § 381.305 and con- single-ingredient, raw poultry products identified in § 381.444, unless the product is ex- tainer closure technicians shall be empted under § 381.500. Nutrition labeling under the direct supervision of a person must be provided for the major cuts of sin- who has successfully completed a gle-ingredient, raw poultry products identi- school of instruction that is generally fied in § 381.444, either in accordance with the recognized as adequate for properly provisions of § 381.409 for nutrition labels, or training supervisors of canning oper- in accordance with the provisions of § 381.445 ations. for point-of-purchase materials, except as exempted under § 381.500. For all other products [51 FR 45634, Dec. 19, 1986] that require nutrition labeling, including

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ground or chopped poultry products de- any alternate panel that can be readily scribed in § 381.401, nutrition labeling must seen by consumers for the nutrition in- be provided in accordance with the provi- formation. In determining the suffi- sions of § 381.409, except as exempted under ciency of available space for the nutri- § 381.500. (b) Nutrition labeling may be provided for tion information, the space needed for single-ingredient, raw poultry products that vignettes, designs, and other non- are not ground or chopped poultry products mandatory label information on the described in § 381.401 and that are not major principal display panel may be consid- cuts of single-ingredient, raw poultry prod- ered. ucts identified in § 381.444, either in accordance with the provisions of § 381.409 for nutri- [58 FR 675, Jan. 6, 1993, as amended at 59 FR tion labels, or in accordance with the provi- 40215, Aug. 8, 1994] sions of § 381.445 for point-of-purchase materials. §§ 381.403–381.407 [Reserved]

* * * * * § 381.408 Labeling of poultry products with number of servings. § 381.401 Required nutrition labeling The label of any package of a poultry of ground or chopped poultry prod- product that bears a representation as ucts. to the number of servings contained in Nutrition labels must be provided for such package shall meet the require- all ground or chopped poultry (kind) ments of § 381.121(c)(7). with or without added seasonings (including, but not limited to, ground § 381.409 Nutrition label content. chicken, ground turkey, and (kind) (a) All nutrient and food component burgers) that are intended for human quantities shall be declared in relation consumption and offered for sale, in ac- to a serving as defined in this section. cordance with the provisions of (b)(1) The term ‘‘serving’’ or ‘‘serving § 381.409, except as exempted under size’’ means an amount of food custom- § 381.500. arily consumed per eating occasion by [75 FR 82166, Dec. 29, 2010] persons 4 years of age or older, which is expressed in a common household EFFECTIVE DATE NOTE: At 75 FR 82166, Dec. 29, 2010, § 381.401 was added, effective Jan. 1, measure that is appropriate to the 2012. At 76 FR 76890, Dec. 9, 2011, the effec- product. When the product is specially tiveness was delayed until Mar. 1, 2012. formulated or processed for use by infants or by toddlers, a serving or serv- § 381.402 Location of nutrition infor- ing size means an amount of food cus- mation. tomarily consumed per eating occasion (a) Nutrition information on a label by infants up to 12 months of age or by of a packaged poultry product shall ap- children 1 through 3 years of age, re- pear on the label’s principal display spectively. panel or on the information panel, ex- (2) Except as provided in paragraphs cept as provided in paragraphs (b) and (b)(8), (b)(12), and (b)(14) of this section (c) of this section. and for products that are intended for (b) Nutrition information for gift weight control and are available only packs may be shown at a location through a weight-control or weight- other than on the product label, pro- maintenance program, the serving size vided that the labels for these products declared on a product label shall be de- bear no nutrition claim. In lieu of on termined from the ‘‘Reference the product label, nutrition informa- Amounts Customarily Consumed Per tion may be provided by alternate Eating Occasion—General Food Sup- means such as product label inserts. ply’’ (Reference Amount(s)) that ap- (c) Poultry products in packages that pear in § 381.412(b) using the procedures have a total surface area available to described in this paragraph (b). For bear labeling greater than 40 square products that are both intended for inches but whose principal display weight control and available only panel and information panel do not through a weight-control program, a provide sufficient space to accommo- manufacturer may determine the serv- date all required information may use ing size that is consistent with the

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meal plan of the program. Such prod- (v) For products that have Reference ucts must bear a statement, ‘‘for sale Amounts of 100 grams (or milliliter) or only through the lll program’’ (fill larger and are individual units within a in the blank with the name of the ap- multi-serving package, if a unit con- propriate weight-control program, e.g., tains more than 150 percent but less Smith’s Weight Control), on the prin- than 200 percent of the Reference cipal display panel. However, the Ref- Amount, the manufacturer may decide erence Amounts in § 381.412(b) shall be whether to declare the individual unit used for purposes of evaluating wheth- as 1 or 2 servings. er weight-control products that are (vi) For products which consist of available only through a weight-con- two or more foods packaged and pre- trol program qualify for nutrition sented to be consumed together where claims. the ingredient represented as the main (3) The declaration of nutrient and ingredient is in discrete units (e.g., food component content shall be on the chicken wings and barbecue sauce), the basis of the product ‘‘as packaged’’ for serving size may be the number of dis- all products, except that single-ingre- crete units represented as the main in- dient, raw products may be declared on gredient plus proportioned minor in- the basis of the product ‘‘as consumed’’ gredients used to make the Reference as set forth in § 381.445(a)(1). In addition Amount for the combined product as to the required declaration on the basis determined in § 381.412(c). of ‘‘as packaged’’ for products other (vii) For packages containing several than single ingredient, raw products, individual single-serving containers, the declaration may also be made on each of which is labeled with all re- the basis of ‘‘as consumed,’’ provided quired information including nutrition that preparation and cooking instruc- labeling as specified in this section tions are clearly stated. (i.e., are labeled appropriately for indi- (4) For products in discrete units vidual sale as single-serving con- (e.g., chicken wings, and individually tainers), the serving size shall be 1 packaged products within a multi-serv- unit. ing package), and for products which (5) For products in large discrete consist of two or more foods packaged units that are usually divided for con- and presented to be consumed together sumption (e.g., pizza, pan of poultry where the ingredient represented as the lasagna), for unprepared products main ingredient is in discrete units where the entire contents of the pack- (e.g., chicken wings and barbecue age is used to prepare large discrete sauce), the serving size shall be de- units that are usually divided for con- clared as follows: sumption (e.g., pizza kit), and for prod- (i) If a unit weighs 50 percent or less ucts which consist of two or more foods of the Reference Amount, the serving packaged and presented to be con- size shall be the number of whole units sumed together where the ingredient that most closely approximates the represented as the main ingredient is a Reference Amount for the product cat- large discrete unit usually divided for egory. consumption, the serving size shall be (ii) If a unit weighs more than 50 per- the fractional slice of the ready-to-eat cent but less than 67 percent of the product (e.g., 1⁄8 quiche, 1⁄4 pizza) that Reference Amount, the manufacturer most closely approximates the Ref- may declare one unit or two units as erence Amount for the product cat- the serving size. egory. The serving size may be the (iii) If a unit weighs 67 percent or fraction of the package used to make more but less than 200 percent of the the Reference Amount for the unpre- Reference Amount, the serving size pared product determined in § 381.412(d) shall be one unit. or the fraction of the large discrete (iv) If a unit weighs 200 percent or unit represented as the main ingre- more of the Reference Amount, the dient plus proportioned minor ingredi- manufacturer may declare one unit as ents used to make the Reference the serving size if the whole unit can Amount of the combined product deter- reasonably be consumed at a single mined in § 381.412(c). In expressing the eating occasion. fractional slice, manufacturers shall

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use 1⁄2, 1⁄3, 1⁄4, 1⁄5, 1⁄6, or smaller fractions rounding indicated by the use of the that can be generated by further divi- term ‘‘about’’ (e.g., about 2.5 ounces). sion by 2 or 3. (iv) A description of the individual (6) For nondiscrete bulk products container or package shall be used for (e.g., whole turkey, turkey breast, single-serving containers and for indi- ground poultry), and for products vidually packaged products within which consist of two or more foods multi-serving containers (e.g., can, packaged and presented to be con- box, package, meal, or dinner). A de- sumed together where the ingredient scription of the individual unit shall be represented as the main ingredient is a used for other products in discrete bulk product (e.g., turkey breast and units (e.g., wing, slice, link, or patty). gravy), the serving size shall be the (v) For unprepared products where amount in household measure that the entire contents of the package is most closely approximates the Ref- used to prepare large discrete units erence Amount for the product cat- that are usually divided for consump- egory and may be the amount of the tion (e.g., pizza kit), the fraction or bulk product represented as the main portion of the package may be used. ingredient plus proportioned minor in- (vi) For products that consist of two gredients used to make the Reference or more distinct ingredients or compo- Amount for the combined product de- nents packaged and presented to be termined in § 381.412(c). consumed together (e.g., chicken wings (7) For labeling purposes, the term with a glaze packet), the nutrition in- ‘‘common household measure’’ or formation may be declared for each ‘‘common household unit’’ means cup, component or as a composite. The serv- tablespoon, teaspoon, piece, slice, frac- ing size may be provided in accordance with the provisions of paragraphs tion (e.g., 1⁄4 pizza), ounce (oz), or other common household equipment used to (b)(4), (b)(5), and (b)(6) of this section. (vii) For nutrition labeling purposes, package food products (e.g., jar or a teaspoon means 5 milliliters (mL), a tray). In expressing serving size in tablespoon means 15 mL, a cup means household measures, except as speci- 240 mL, and 1 oz in weight means 28 fied in paragraphs (b)(7)(iv), (v), and grams (g). (vi) of this section, the following rules (viii) When a serving size, determined shall be used: from the Reference Amount in (i) Cups, tablespoons, or teaspoons § 381.412(b) and the procedures described shall be used wherever possible and ap- in this section, falls exactly half way 1 propriate. Cups shall be expressed in ⁄4- between two serving sizes (e.g., 2.5 1 or ⁄3-cup increments, tablespoons in tbsp), manufacturers shall round the whole number of tablespoons for quan- serving size up to the next incremental 1 tities less than ⁄4 cup but greater than size. 1 or equal to 2 tablespoons (tbsp), 1, 1 ⁄3, (8) A product that is packaged and 11⁄2, or 12⁄3 tbsp for quantities less than sold individually and that contains less 2 tbsp but greater than or equal to 1 than 200 percent of the applicable Ref- tbsp, and teaspoons in whole number of erence Amount shall be considered to teaspoons for quantities less than 1 be a single-serving container, and the tbsp but greater than or equal to 1 tea- entire content of the product shall be spoon (tsp), and in 1⁄4-tsp increments labeled as one serving, except for prod- for quantities less than 1 tsp. ucts that have Reference Amounts of (ii) If cups, tablespoons or teaspoons 100 g (or mL) or larger, manufacturers are not applicable, units such as piece, may decide whether a package that slice, tray, jar, and fraction shall be contains more than 150 percent but less used. than 200 percent of the Reference (iii) If cups, tablespoons and Amount is 1 or 2 servings. Packages teaspoons, or units such as piece, slice, sold individually that contain 200 per- tray, jar, or fraction are not applicable, cent or more of the applicable Ref- ounces may be used. Ounce measure- erence Amount may be labeled as a sin- ments shall be expressed in 0.5-ounce gle-serving if the entire content of the increments most closely approxi- package can reasonably be consumed mating the Reference Amount with at a single-eating occasion.

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(9) A label statement regarding a tween 2 and 5 servings and random serving shall be the serving size ex- weight products. The number of pressed in common household measures servings between 2 and 5 servings shall as set forth in paragraphs (b)(2) be rounded to the nearest 0.5 serving. through (b)(8) of this section and shall Rounding should be indicated by the be followed by the equivalent metric use of the term ‘‘about’’ (e.g., about 2 quantity in parenthesis (fluids in milli- servings; about 3.5 servings). liters and all other foods in grams), ex- (ii) When the serving size is required cept for single-serving containers. to be expressed on a drained solids (i) For a single-serving container, the basis and the number of servings varies parenthetical metric quantity, which because of a natural variation in unit will be presented as part of the net size, the manufacturer may state the weight statement on the principal dis- typical number of servings per con- play panel, is not required except tainer (e.g., usually 5 servings). where nutrition information is re- (iii) For random weight products, a quired on a drained weight basis ac- manufacturer may declare ‘‘varied’’ for cording to paragraph (b)(11) of this sec- the number of servings per container tion. However, if a manufacturer vol- provided the nutrition information is untarily provides the metric quantity based on the Reference Amount ex- on products that can be sold as single pressed in ounces. The manufacturer servings, then the numerical value pro- may provide the typical number of vided as part of the serving size dec- servings in parenthesis following the laration must be identical to the met- ‘‘varied’’ statement (e.g., varied (ap- ric quantity declaration provided as proximately 8 servings per pound)). part of the net quantity of contents (iv) For packages containing several statement. individual single-serving containers, (ii) The gram or milliliter quantity each of which is labeled with all re- equivalent to the household measure quired information including nutrition should be rounded to the nearest whole labeling as specified in this section number except for quantities that are (i.e., are labeled appropriately for indi- less than 5 g (mL). The gram (mL) vidual sale as single-serving con- quantity between 2 and 5 g (mL) should tainers), the number of servings shall be rounded to the nearest 0.5 g (mL) be the number of individual packages and the g (mL) quantity less than 2 g within the total package. (mL) should be expressed in 0.1-g (mL) (v) For packages containing several increments. individually packaged multi-serving (iii) In addition, serving size may be units, the number of servings shall be declared in ounce, in parenthesis, fol- determined by multiplying the number lowing the metric measure separated of individual multi-serving units in the by a slash where other common house- total package by the number of hold measures are used as the primary servings in each individual unit. unit for serving size, e.g., 1 slice (28 g/ (11) The declaration of nutrient and 1 oz) for sliced chicken roll. The ounce food component content shall be on the quantity equivalent to the metric basis of product as packaged or pur- quantity should be expressed in 0.1-oz chased with the exception of products increments. that are packed or canned in water, (iv) If a manufacturer elects to use brine, or oil but whose liquid packing abbreviations for units, the following medium is not customarily consumed. abbreviations shall be used: tbsp for ta- Declaration of the nutrient and food blespoon, tsp for teaspoon, g for gram, component content of products that mL for milliliter, and oz for ounce. are packed in liquid which is not cus- (10) Determination of the number of tomarily consumed shall be based on servings per container shall be based the drained solids. on the serving size of the product de- (12) The serving size for meal-type termined by following the procedures products and main-dish products as de- described in this section. fined in § 381.413(l) and § 381.413 (m) in (i) The number of servings shall be single-serve containers will be the en- rounded to the nearest whole number tire edible content of the package. except for the number of servings be- Serving size for meal-type products and

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main-dish products in multi-serve con- nutrition label. Except as provided for tainers will be based on the reference in paragraph (f) or (g) of this section, amount applicable to the product in nutrient information shall be presented § 381.412(b) if the product is listed in using the nutrient names specified and § 381.412(b). Serving size for meal-type in the following order in the formats products and main-dish products in specified in paragraph (d) or (e) of this multi-serve containers that are not section. listed in § 381.412(b) will be based on the (1) ‘‘Calories, total,’’ ‘‘Total cal- reference amount according to ories,’’ or ‘‘Calories’’: A statement of § 381.412(c), (d), and (e). the caloric content per serving, ex- (13) Another column of figures may pressed to the nearest 5-calorie incre- be used to declare the nutrient and ment up to and including 50 calories, food component information in the and 10-calorie increment above 50 cal- same format as required by § 381.409(e), ories, except that amounts less than 5 (i) Per 100 grams, 100 milliliters, or 1 calories may be expressed as zero. En- ounce of the product as packaged or ergy content per serving may also be purchased. expressed in kilojoule units, added in (ii) Per one unit if the serving size of parenthesis immediately following the a product in discrete units in a multi- statement of the caloric content. serving container is more than one (i) Caloric content may be calculated unit. by the following methods. Where either (14) If a product consists of assort- specific or general food factors are ments of poultry products (e.g., variety used, the factors shall be applied to the packs) in the same package, nutrient actual amount (i.e., before rounding) of content shall be expressed on the en- food components (e.g., fat, carbo- tire package contents or on each indi- hydrate, protein, or ingredients with vidual product. specific food factors) present per serv- (15) If a product is commonly coming. bined with other ingredients or is (A) Using specific Atwater factors cooked or otherwise prepared before (i.e., the Atwater method) given in eating, and directions for such com- Table 13, page 25, ‘‘Energy Value of bination or preparations are provided, Foods—Basis and Derivation,’’ by A. L. another column of figures may be used Merrill and B. K. Watt, United States to declare the nutrient contents on the Department of Agriculture (USDA), basis of the product as consumed for Agriculture Handbook No. 74 (Slightly the product alone (e.g., a cream soup revised February 1973), which is incor- mix may be labeled with one set of porated by reference. Table 13 of the Daily Values for the dry mix (per serv- ‘‘Energy Value of Foods—Basis and ing), and another set for the serving of Derivation,’’ Agriculture Handbook No. the final soup when prepared (e.g., per 74 is incorporated as it exists on the serving of cream soup mix and 1 cup of date of approval. This incorporation by vitamin D fortified whole milk)): Pro- reference was approved by the Director vided, that the type and quantity of the of the Federal Register in accordance other ingredients to be added to the with 5 U.S.C. 552(a) and 1 CFR part 51. product by the user and the specific It is available for inspection at the of- method of cooking and other prepara- fice of the FSIS Docket Clerk, Room tion shall be specified prominently on 3171, South Building, 14th and Inde- the label. pendence Avenue, SW., Washington, (c) The declaration of nutrition infor- DC, or at the National Archives and mation on the label or in labeling of a Records Administration (NARA). For poultry product shall contain informa- information on the availability of this tion about the level of the following material at NARA, call 202–741–6030, or nutrients, except for those nutrients go to: http://www.archives.gov/ whose inclusion, and the declaration of federallregister/ amounts, is voluntary as set forth in codeloflfederallregulations/ this paragraph. No nutrients or food ibrllocations.html. Copies of the incor- components other than those listed in poration by reference are available this paragraph as either mandatory or from the Product Assessment Division, voluntary may be included within the Regulatory Programs, Food Safety and

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Inspection Service, U.S. Department of voluntarily, expressed to the nearest 5- Agriculture, Room 329, West End Court calorie increment, up to and including Building, Washington, DC 20250–3700; 50 calories, and the nearest 10-calorie (B) Using the general factors of 4, 4, increment above 50 calories, except and 9 calories per gram for protein, that amounts less than 5 calories may total carbohydrate, and total fat, re- be expressed as zero. This statement spectively, as described in USDA’s Ag- shall be indented under the statement riculture Handbook No. 74 (Slightly re- of calories from fat as provided in para- vised February 1973), pages 9–11, which graph (d)(5) of this section. is incorporated by reference. Pages 9– (2) ‘‘Fat, total’’ or ‘‘Total fat’’: A 11, Agriculture Handbook No. 74 is in- statement of the number of grams of corporated as it exists on the date of total fat per serving defined as total approval. This incorporation by ref- lipid fatty acids and expressed as erence was approved by the Director of triglycerides. Amounts shall be ex- the Federal Register in accordance pressed to the nearest 0.5 (1⁄2)-gram in- with 5 U.S.C. 552(a) and 1 CFR part 51. crement below 5 grams and to the near- (The availability of this incorporation est gram increment above 5 grams. If by reference is given in paragraph the serving contains less than 0.5 gram, (c)(1)(i)(A) of this section.); the content shall be expressed as zero. (C) Using the general factors of 4, 4, (i) ‘‘Saturated fat’’ or ‘‘Saturated’’: A and 9 calories per gram for protein, statement of the number of grams of total carbohydrate less the amount of saturated fat per serving defined as the insoluble dietary fiber, and total fat, sum of all fatty acids containing no respectively, as described in USDA’s double bonds, except that label dec- Agriculture Handbook No. 74 (Slightly laration of saturated fat content infor- revised February 1973), pages 9–11, mation is not required for products which is incorporated by reference in that contain less than 0.5 gram of total accordance with 5 U.S.C. 552(a) and 1 fat per serving if no claims are made CFR part 51. (The availability of this about fat or cholesterol content, and if incorporation by reference is given in ‘‘calories from saturated fat’’ is not de- paragraph (c)(1)(i)(A) of this section.); clared. Saturated fat content shall be or indented and expressed as grams per (D) Using data for specific food fac- serving to the nearest 0.5 (1⁄2)-gram in- tors for particular foods or ingredients crement below 5 grams and to the near- approved by the Food and Drug Admin- est gram increment above 5 grams. If istration (FDA) and provided in parts the serving contains less than 0.5 gram, 172 or 184 of 21 CFR, or by other means, the content shall be expressed as zero. as appropriate. (A) ‘‘Stearic Acid’’ (VOLUNTARY): A (ii) ‘‘Calories from fat’’: A statement statement of the number of grams of of the caloric content derived from stearic acid per serving may be de- total fat as defined in paragraph (c)(2) clared voluntarily, except that when a of this section per serving, expressed to claim is made about stearic acid, label the nearest 5-calorie increment, up to declaration shall be required. Stearic and including 50 calories, and the near- acid content shall be indented under est 10-calorie increment above 50 cal- saturated fat and expressed to the ories, except that label declaration of nearest 0.5 (1⁄2)-gram increment below 5 ‘‘calories from fat’’ is not required on grams and the nearest gram increment products that contain less than 0.5 above 5 grams. If the serving contains gram of fat per serving and amounts less than 0.5 gram, the content shall be less than 5 calories may be expressed as expressed as zero. zero. This statement shall be declared (B) [Reserved] as provided in paragraph (d)(5) of this (ii) ‘‘Polyunsaturated fat’’ or ‘‘Poly- section. unsaturated’’ (VOLUNTARY): A state- (iii) ‘‘Calories from saturated fat’’ or ment of the number of grams of poly- ‘‘Calories from saturated’’ (VOL- unsaturated fat per serving defined as UNTARY): A statement of the caloric cis,cis-methylene-interrupted poly- content derived from saturated fat as unsaturated fatty acids may be de- defined in paragraph (c)(2)(i) of this clared voluntarily, except that when section per serving may be declared monounsaturated fat is declared, or

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when a claim about fatty acids or cho- (5) ‘‘Potassium’’ (VOLUNTARY): A lesterol is made on the label or in la- statement of the number of milligrams beling of a product other than one that of potassium per serving may be de- meets the criteria in § 381.462(b)(1) for a clared voluntarily, except that when a claim for ‘‘fat free,’’ label declaration claim is made about potassium con- of polyunsaturated fat is required. tent, label declaration shall be re- Polyunsaturated fat content shall be quired. Potassium content shall be ex- indented and expressed as grams per pressed as zero when the serving con- serving to the nearest 0.5 (1⁄2)-gram in- tains less than 5 milligrams of potas- crement below 5 grams and to the near- sium, to the nearest 5-milligram incre- est gram increment above 5 grams. If ment when the serving contains 5 to the serving contains less than 0.5 gram, 140 milligrams of potassium, and to the the content shall be expressed as zero. nearest 10-milligram increment when (iii) ‘‘Monounsaturated fat’’ or the serving contains greater than 140 ‘‘Monounsaturated’’ (VOLUNTARY): A milligrams. statement of the number of grams of (6) ‘‘Carbohydrate, total’’ or ‘‘Total monounsaturated fat per serving de- carbohydrate’’: A statement of the fined as cis-monounsaturated fatty number of grams of total carbohydrate acids may be declared voluntarily, ex- per serving expressed to the nearest cept that when polyunsaturated fat is gram, except that if a serving contains declared, or when a claim about fatty less than 1 gram, the statement ‘‘Con- acids or cholesterol is made on the tains less than 1 gram’’ or ‘‘less than 1 label or in labeling of a product other gram’’ may be used as an alternative, than one that meets the criteria in or, if the serving contains less than 0.5 § 381.462(b)(1) for a claim for ‘‘fat free,’’ gram, the content may be expressed as label declaration of monounsaturated zero. Total carbohydrate content shall fat is required. Monounsaturated fat be calculated by subtraction of the sum content shall be indented and expressed of the crude protein, total fat, mois- as grams per serving to the nearest 0.5 ture, and ash from the total weight of (1⁄2)-gram increment below 5 grams and the product. This calculation method is to the nearest gram increment above 5 described in USDA’s Agriculture Hand- grams. If the serving contains less than book No. 74 (Slightly revised February 0.5 gram, the content shall be expressed 1973), pages 2 and 3, which is incor- as zero. porated by reference. Pages 2 and 3, Ag- (3) ‘‘Cholesterol’’: A statement of the riculture Handbook No. 74 is incor- cholesterol content per serving ex- porated as it exists on the date of ap- pressed in milligrams to the nearest 5- proval. This incorporation by reference milligram increment, except that label was approved by the Director of the declaration of cholesterol information Federal Register in accordance with 5 is not required for products that con- U.S.C. 552(a) and 1 CFR part 51. (The tain less than 2 milligrams of choles- availability of this incorporation by terol per serving and make no claim reference is given in paragraph about fat, fatty acids, or cholesterol (c)(1)(i)(A) of this section.). content, or such products may state (i) ‘‘Dietary fiber’’: A statement of the cholesterol content as zero. If the the number of grams of total dietary product contains 2 to 5 milligrams of fiber per serving, indented and ex- cholesterol per serving, the content pressed to the nearest gram, except may be stated as ‘‘less than 5 milli- that if a serving contains less than 1 grams.’’ gram, declaration of dietary fiber is (4) ‘‘Sodium’’: A statement of the not required, or, alternatively, the number of milligrams of sodium per statement ‘‘Contains less than 1 gram’’ serving expressed as zero when the or ‘‘less than 1 gram’’ may be used, and serving contains less than 5 milligrams if the serving contains less than 0.5 of sodium, to the nearest 5-milligram gram, the content may be expressed as increment when the serving contains 5 zero. to 140 milligrams of sodium, and to the (A) ‘‘Soluble fiber’’ (VOLUNTARY): nearest 10-milligram increment when A statement of the number of grams of the serving contains greater than 140 soluble dietary fiber per serving may milligrams. be declared voluntarily except when a

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claim is made on the label or in label- tone or aldehyde group and whose use ing about soluble fiber, label declara- in the food is listed by FDA (e.g., tion shall be required. Soluble fiber mannitol or xylitol) or is generally rec- content shall be indented under dietary ognized as safe (e.g., sorbitol). In lieu fiber and expressed to the nearest of the term ‘‘sugar alcohol,’’ the name gram, except that if a serving contains of the specific sugar alcohol (e.g., less than 1 gram, the statement ‘‘Con- ‘‘xylitol’’) present in the product may tains less than 1 gram’’ or ‘‘less than 1 be used in the nutrition label, provided gram’’ may be used as an alternative, that only one sugar alcohol is present and if the serving contains less than 0.5 in the product. Sugar alcohol content gram, the content may be expressed as shall be indented and expressed to the zero. nearest gram, except that if a serving (B) ‘‘Insoluble fiber’’ (VOLUNTARY): contains less than 1 gram, the state- A statement of the number of grams of ment ‘‘Contains less than 1 gram’’ or insoluble dietary fiber per serving may ‘‘less than 1 gram’’ may be used as an be declared voluntarily except when a alternative, and if the serving contains claim is made on the label or in label- less than 0.5 gram, the content may be ing about insoluble fiber, label declara- expressed as zero. tion shall be required. Insoluble fiber (iv) ‘‘Other carbohydrate’’ (VOL- content shall be indented under dietary UNTARY): A statement of the number fiber and expressed to the nearest of grams of other carbohydrate per gram, except that if a serving contains serving may be declared voluntarily. less than 1 gram, the statement ‘‘Con- Other carbohydrate shall be defined as tains less than 1 gram’’ or ‘‘less than 1 the difference between total carbo- gram’’ may be used as an alternative, hydrate and the sum of dietary fiber, and if the serving contains less than 0.5 sugars, and sugar alcohol, except that gram, the content may be expressed as if sugar alcohol is not declared (even if zero. present), it shall be defined as the dif- (ii) ‘‘Sugars’’: A statement of the ference between total carbohydrate and number of grams of sugars per serving, the sum of dietary fiber and sugars. except that label declaration of sugars Other carbohydrate content shall be in- content is not required for products dented and expressed to the nearest that contain less than 1 gram of sugars gram, except that if a serving contains per serving if no claims are made about less than 1 gram, the statement ‘‘Con- sweeteners, sugars, or sugar alcohol tains less than 1 gram’’ or ‘‘less than 1 content. Sugars shall be defined as the gram’’ may be used as an alternative, sum of all free mono- and disaccharides and if the serving contains less than 0.5 (such as glucose, fructose, lactose, and gram, the content may be expressed as sucrose). Sugars content shall be in- zero. dented and expressed to the nearest (7) ‘‘Protein’’: A statement of the gram, except that if a serving contains number of grams of protein per serving less than 1 gram, the statement ‘‘Con- expressed to the nearest gram, except tains less than 1 gram’’ or ‘‘less than 1 that if a serving contains less than 1 gram’’ may be used as an alternative, gram, the statement ‘‘Contains less and if the serving contains less than 0.5 than 1 gram’’ or ‘‘less than 1 gram’’ gram, the content may be expressed as may be used as an alternative, and if zero. the serving contains less than 0.5 gram, (iii) ‘‘Sugar alcohol’’ (VOLUNTARY): the content may be expressed as zero. A statement of the number of grams of When the protein in products rep- sugar alcohols per serving may be de- resented or purported to be for adults clared voluntarily on the label, except and children 4 or more years of age has that when a claim is made on the label a protein quality value that is a pro- or in labeling about sugar alcohol or tein digestibility-corrected amino acid sugars when sugar alcohols are present score of less than 20 expressed as a per- in the product, sugar alcohol content cent, or when the protein in a product shall be declared. For nutrition label- represented or purported to be for chil- ing purposes, sugar alcohols are defined dren greater than 1 but less than 4 as the sum of saccharide derivatives in years of age has a protein quality value which a hydroxyl group replaces a ke- that is a protein digestibility-corrected

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amino acid score of less than 40 ex- (grams) per serving multiplied by the pressed as a percent, either of the fol- amino acid score corrected for protein lowing shall be placed adjacent to the digestibility. If the corrected score is declaration of protein content by above 1.00, then it shall be set at 1.00. weight: The statement ‘‘not a signifi- The protein digestibility-corrected cant source of protein,’’ or a listing amino acid score shall be determined aligned under the column headed by methods given in sections 5.4.1, 7.2.1, ‘‘Percent Daily Value’’ of the corrected and 8 in ‘‘Protein Quality Evaluation, amount of protein per serving, as de- Report of the Joint FAO/WHO Expert termined in paragraph (c)(7)(ii) of this Consultation on Protein Quality Eval- section, calculated as a percentage of uation,’’ Rome, 1990, which is incor- the Daily Reference Value (DRV) or porated by reference. Sections 5.4.1, Reference Daily Intake (RDI), as appro- 7.2.1, and 8 of the ‘‘Report of the Joint priate, for protein and expressed as per- FAO/WHO Expert Consultation on Pro- cent of Daily Value. When the protein tein Quality Evaluation,’’ as published quality in a product as measured by by the Food and Agriculture Organiza- the Protein Efficiency Ratio (PER) is tion of the United Nations/World less than 40 percent of the reference Health Organization, is incorporated as standard (casein) for a product rep- it exists on the date of approval. This resented or purported to be for infants, incorporation by reference was ap- the statement ‘‘not a significant source proved by the Director of the Federal of protein’’ shall be placed adjacent to Register in accordance with 5 U.S.C. the declaration of protein content. Pro- 552(a) and 1 CFR part 51. It is available tein content may be calculated on the for inspection at the office of the FSIS basis of the factor of 6.25 times the ni- Docket Clerk, Room 3171, South Build- trogen content of the food as deter- ing, 14th and Independence Avenue, mined by appropriate methods of anal- SW., Washington, DC, or at the Na- ysis in accordance with § 381.409(h), ex- tional Archives and Records Adminis- cept when the procedure for a specific tration (NARA). For information on food requires another factor. the availability of this material at (i) A statement of the corrected NARA, call 202–741–6030, or go to: http:// amount of protein per serving, as de- www.archives.gov/federallregister/ termined in paragraph (c)(7)(ii) of this codeloflfederallregulations/ section, calculated as a percentage of ibrllocations.html. Copies of the incor- the RDI or DRV for protein, as appro- poration by reference are available priate, and expressed as percent of from the Product Assessment Division, Daily Value, may be placed on the Regulatory Programs, Food Safety and label, except that such a statement Inspection Service, U.S. Department of shall be given if a protein claim is Agriculture, Room 329, West End Court made for the product, or if the product Building, Washington, DC 20250–3700. is represented or purported to be for in- For products represented or purported fants or children under 4 years of age. to be for infants, the corrected amount When such a declaration is provided, it of protein (grams) per serving is equal shall be placed on the label adjacent to to the actual amount of protein the statement of grams of protein and (grams) per serving multiplied by the aligned under the column headed relative protein quality value. The rel- ‘‘Percent Daily Value,’’ and expressed ative protein quality value shall be de- to the nearest whole percent. However, termined by dividing the subject prod- the percentage of the RDI for protein uct’s protein PER value by the PER shall not be declared if the product is value for casein. If the relative protein represented or purported to be for in- value is above 1.00, it shall be set at fants and the protein quality value is 1.00. less than 40 percent of the reference (iii) For the purpose of labeling with standard. a percent of the DRV or RDI, a value of (ii) The corrected amount of protein 50 grams of protein shall be the DRV (grams) per serving for products rep- for adults and children 4 or more years resented or purported to be for adults of age, and the RDI for protein for chil- and children 1 or more years of age is dren less than 4 years of age, infants, equal to the actual amount of protein pregnant women, and lactating women

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shall be 16 grams, 14 grams, 60 grams, (B) Included in a product solely for and 65 grams, respectively. technological purposes and declared (8) Vitamins and minerals: A state- only in the ingredients statement. The ment of the amount per serving of the declaration may also include any of the vitamins and minerals as described in other vitamins and minerals listed in this paragraph, calculated as a percent paragraph (c)(8)(iv) of this section of the RDI and expressed as percent of when they are naturally occurring in Daily Value. the food. The additional vitamins and (i) For purposes of declaration of per- minerals shall be listed in the order es- cent of Daily Value as provided for in tablished in paragraph (c)(8)(iv) of this paragraphs (d) through (g) of this sec- section. (iii) The percentages for vitamins tion, products represented or purported and minerals shall be expressed to the to be for use by infants, children less nearest 2-percent increment up to and than 4 years of age, pregnant women, including the 10-percent level, the or lactating women shall use the RDI’s nearest 5-percent increment above 10 that are specified for the intended percent and up to and including the 50- group. For products represented or pur- percent level, and the nearest 10-per- ported to be for use by both infants and cent increment above the 50-percent children under 4 years of age, the per- level. Amounts of vitamins and min- cent of Daily Value shall be presented erals present at less than 2 percent of by separate declarations according to the RDI are not required to be declared paragraph (e) of this section based on in nutrition labeling but may be de- the RDI values for infants from birth clared by a zero or by the use of an as- to 12 months of age and for children terisk (or other symbol) that refers to under 4 years of age. Similarly, the another asterisk (or symbol) that is percent of Daily Value based on both placed at the bottom of the table and the RDI values for pregnant women that is followed by the statement and for lactating women shall be de- ‘‘Contains less than 2 percent of the clared separately on products rep- Daily Value of this (these) nutrient resented or purported to be for use by (nutrients).’’ Alternatively, if vitamin both pregnant and lactating women. A, vitamin C, calcium, or iron is When such dual declaration is used on present in amounts less than 2 percent any label, it shall be included in all la- of the RDI, label declaration of the nu- beling, and equal prominence shall be trient(s) is not required if the state- given to both values in all such label- ment ‘‘Not a significant source of ing. All other products shall use the llll (listing the vitamins or min- RDI for adults and children 4 or more erals omitted)’’ is placed at the bottom years of age. of the table of nutrient values. (ii) The declaration of vitamins and (iv) The following RDI’s and nomen- minerals as a percent of the RDI shall clature are established for the fol- include vitamin A, vitamin C, calcium, lowing vitamins and minerals which and iron, in that order, and shall in- are essential in human nutrition: clude any of the other vitamins and Vitamin A, 5,000 International Units minerals listed in paragraph (c)(8)(iv) Vitamin C, 60 milligrams of this section when they are added, or Calcium, 1.0 gram when a claim is made about them. Iron, 18 milligrams Other vitamins and minerals need not Vitamin D, 400 International Units be declared if neither the nutrient nor Vitamin E, 30 International Units the component is otherwise referred to Thiamin, 1.5 milligrams Riboflavin, 1.7 milligrams on the label or in labeling or adver- Niacin, 20 milligrams tising and the vitamins and minerals Vitamin B6, 2.0 milligrams are: Folate, 0.4 milligram (A) Required or permitted in a stand- Vitamin B12, 6 micrograms ardized food (e.g., thiamin, riboflavin, Biotin, 0.3 milligram and niacin in enriched flour) and that Pantothenic acid, 10 milligrams Phosphorus, 1.0 gram standardized food is included as an in- Iodine, 150 micrograms gredient (i.e., component) in another Magnesium, 400 milligrams product; or Zinc, 15 milligrams

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Copper, 2.0 milligrams inches as provided for in paragraph (g) (v) The following synonyms may be of this section. added in parenthesis immediately fol- (i) The nutrition information shall be lowing the name of the nutrient or die- set off in a box by use of hairlines and tary component: shall be all black or one color type, printed on a white or other neutral Vitamin C—Ascorbic acid contrasting background whenever prac- Thiamin—Vitamin B 1 tical. Riboflavin—Vitamin B2 Folate—Folacin (ii) All information within the nutri- Calories—Energy tion label shall utilize: (vi) A statement of the percent of vi- (A) A single easy-to-read type style, tamin A that is present as beta-caro- (B) Upper and lower case letters, tene may be declared voluntarily. (C) At least one point leading (i.e., When the vitamins and minerals are space between two lines of text) except listed in a single column, the state- that at least four points leading shall ment shall be indented under the infor- be utilized for the information required mation on vitamin A. When vitamins by paragraphs (d)(7) and (d)(8) of this and minerals are arrayed horizontally, section, and the statement of percent shall be pre- (D) Letters should never touch. sented in parenthesis following the dec- (iii) Information required in para- laration of vitamin A and the percent graphs (d)(3), (d)(5), (d)(7), and (d)(8) of of Daily Value of vitamin A in the this section shall be in type size no product (e.g., ‘‘Percent Daily Value: smaller than 8 point. Except for the Vitamin A 50 (90 percent as beta-caro- heading ‘‘Nutrition Facts,’’ the infor- tene)’’). When declared, the percent- mation required in paragraphs (d)(4), ages shall be expressed in the same in- (d)(6), and (d)(9) of this section and all crements as are provided for vitamins other information contained within the and minerals in paragraph (c)(8)(iii) of nutrition label shall be in type size no this section. smaller than 6 point. When provided, (9) For the purpose of labeling with a the information described in paragraph percent of the DRV, the following (d)(10) of this section shall also be in DRV’s are established for the following type no smaller than 6 point. food components based on the reference (iv) The headings required by para- caloric intake of 2,000 calories: graphs (d)(2), (d)(4), and (d)(6) of this Food component Unit of measurement DRV section (i.e., ‘‘Nutrition Facts,’’ ‘‘Amount Per Serving,’’ and ‘‘% Daily Fat ...... grams (g) ...... 65 Value*’’), the names of all nutrients Saturated fatty acids ...... do ...... 20 Cholesterol ...... milligrams (mg) ...... 300 that are not indented according to re- Total carbohydrate ...... grams (g) ...... 300 quirements of paragraph (c) of this sec- Fiber ...... do ...... 25 tion (i.e., Calories, Total fat, Choles- Sodium ...... milligrams (mg) ...... 2400 terol, Sodium, Potassium, Total carbo- Potassium ...... do ...... 3500 Protein ...... grams (g) ...... 50 hydrate, and Protein), and the percentage amounts required by paragraph (d)(1) Nutrient information specified (d)(7)(ii) of this section shall be high- in paragraph (c) of this section shall be lighted by bold or extra bold type or presented on products in the following other highlighting (reverse printing is format, except on products on which not permitted as a form of high- dual columns of nutrition information lighting) that prominently distin- are declared as provided for in para- guishes it from other information. No graph (e) of this section, on those prod- other information shall be highlighted. ucts on which the simplified format is (v) A hairline rule that is centered permitted to be used as provided for in between the lines of text shall separate paragraph (f) of this section, on prod- ‘‘Amount Per Serving’’ from the cal- ucts for infants and children less than orie statements required in paragraph 4 years of age as provided for in (d)(5) of this section and shall separate § 381.500(c), and on products in packages each nutrient and its corresponding that have a total surface area available percent of Daily Value required in to bear labeling of 40 or less square paragraphs (d)(7)(i) and (d)(7)(ii) of this

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section from the nutrient and percent tamins and minerals, shall be declared of Daily Value above and below it. as follows: (2) The information shall be pre- (i) The name of each nutrient, as sented under the identifying heading of specified in paragraph (c) of this sec- ‘‘Nutrition Facts’’ which shall be set in tion, shall be given in a column and a type size larger than all other print followed immediately by the quan- size in the nutrition label and, except titative amount by weight for that nu- for labels presented according to the trient appended with a ‘‘g’’ for grams format provided for in paragraph (d)(11) or ‘‘mg’’ for milligrams. of this section, unless impractical, (ii) A listing of the percent of the shall be set the full width of the infor- DRV as established in paragraphs mation provided under paragraph (d)(7) (c)(7)(iii) and (c)(9) of this section shall of this section. be given in a column aligned under the (3) Information on serving size shall heading ‘‘% Daily Value’’ established immediately follow the heading. Such in paragraph (d)(6) of this section with information shall include: the percent expressed to the nearest (i) ‘‘Serving Size’’: A statement of whole percent for each nutrient de- the serving size as specified in para- clared in the column described in paragraph (b)(9) of this section. graph (d)(7)(i) of this section for which (ii) ‘‘Servings Per Container’’: The a DRV has been established, except number of servings per container, ex- that the percent for protein may be cept that this statement is not re- omitted as provided in paragraph (c)(7) quired on single-serving containers as of this section. The percent shall be defined in paragraph (b)(8) of this sec- calculated by dividing either the tion. amount declared on the label for each (4) A subheading ‘‘Amount Per Serv- nutrient or the actual amount of each ing’’ shall be separated from serving nutrient (i.e., before rounding) by the size information by a bar. DRV for the nutrient, except that the (5) Information on calories shall im- percent for protein shall be calculated mediately follow the heading ‘‘Amount as specified in paragraph (c)(7)(ii) of Per Serving’’ and shall be declared in this section. The numerical value shall one line, leaving sufficient space be- be followed by the symbol for percent tween the declaration of ‘‘Calories’’ (i.e., %). and ‘‘Calories from fat’’ to allow clear (8) Nutrient information for vitamins differentiation, or, if ‘‘Calories from and minerals shall be separated from saturated fat’’ is declared, in a column information on other nutrients by a with total ‘‘Calories’’ at the top, fol- bar and shall be arrayed horizontally lowed by ‘‘Calories from fat’’ (in- (e.g., Vitamin A 4%, Vitamin C 2%, dented), and ‘‘Calories from saturated Calcium 15%, Iron 4%) or may be listed fat’’ (indented). in two columns, except that when more (6) The column heading ‘‘% Daily than four vitamins and minerals are Value,’’ followed by an asterisk (e.g., declared, they may be declared ‘‘% Daily Value*’’), shall be separated vertically with percentages listed from information on calories by a bar. under the column headed ‘‘% Daily The position of this column heading Value.’’ shall allow for a list of nutrient names (9) A footnote, preceded by an aster- and amounts as described in paragraph isk, shall be placed beneath the list of (d)(7) of this section to be to the left of, vitamins and minerals and shall be sep- and below, this column heading. The arated from that list by a hairline. column heading ‘‘Percent Daily (i) The footnote shall state: Percent Value,’’ ‘‘Percent DV,’’ or ‘‘% DV’’ may Daily Values are based on a 2,000 cal- be substituted for ‘‘% Daily Value.’’ orie diet. Your daily values may be (7) Except as provided for in para- higher or lower depending on your cal- graph (g) of this section, and except as orie needs. permitted by § 381.500(d)(2), nutrient in- Calories 2,000 2,500 formation for both mandatory and any voluntary nutrients listed in paragraph Total fat ...... Less than ...... 65 g 80 g Saturated fat ... Less than ...... 20 g 25 g (c) of this section that are to be de- Cholesterol ...... Less than ...... 300 mg 300 mg clared in the nutrition label, except vi- Sodium ...... Less than ...... 2400 mg 2400 mg

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Calories 2,000 2,500 graph (d)(7)(ii) of this section and set off by a line that distinguishes it and Total carbo- ...... 300 g 375 g hydrate. sets it apart from the percent of Daily Dietary fiber ...... 25 g 30 g Value information. The caloric conversion information provided for in para- (ii) If the percent of Daily Value is graph (d)(10) of this section may be pre- given for protein in the Percent of sented beneath either side or along the Daily Value column as provided in full length of the nutrition label. paragraph (d)(7)(ii) of this section, pro- (ii) If the space beneath the manda- tein shall be listed under dietary fiber, tory declaration of iron is not adequate and a value of 50 g shall be inserted on to accommodate any remaining vita- the same line in the column headed mins and minerals to be declared or the ‘‘2,000’’ and value of 65 g in the column information required in paragraph headed ‘‘2,500.’’ (d)(9) of this section, the remaining in- (iii) If potassium is declared in the formation may be moved to the right column described in paragraph (d)(7)(i) and set off by a line that distinguishes of this section, potassium shall be list- it and sets it apart from the percent of ed under sodium and the DRV estab- Daily Value information given to the lished in paragraph (c)(9) of this sec- left. The caloric conversion information shall be inserted on the same line tion provided for in paragraph (d)(10) of in the numeric columns. this section may be presented beneath (iv) The abbreviations established in either side or along the full length of paragraph (g)(2) of this section may be the nutrition label. used within the footnote. (iii) If there is not sufficient contin- (10) Caloric conversion information uous vertical space (i.e., approximately on a per-gram basis for fat, carbo- 3 inches) to accommodate the required hydrate, and protein may be presented components of the nutrition label up to beneath the information required in and including the mandatory declara- paragraph (d)(9), separated from that tion of iron, the nutrition label may be information by a hairline. This infor- presented in a tabular display in which mation may be presented horizontally the footnote required by paragraph (i.e., ‘‘Calories per gram: Fat 9, Carbo- (d)(9) of the section is given to the far hydrate 4, Protein 4’’) or vertically in right of the label, and additional vita- columns. mins and minerals beyond the four (11)(i) If the space beneath the infor- that are required (i.e., vitamin A, vita- mation on vitamins and minerals is not min C, calcium, and iron) are arrayed adequate to accommodate the informa- horizontally following declarations of tion required in paragraph (d)(9) of this the required vitamins and minerals. section, the information required in (12) The following sample label illus- paragraph (d)(9) may be moved to the trates the provisions of paragraph (d) right of the column required in para- of this section:

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(13)(i) Nutrition labeling on the outer changeably for the same type of food label of packages of poultry products (e.g., poultry salad containers) may use that contain two or more products in an aggregate display. the same packages (e.g., variety packs) (ii) Aggregate displays shall comply or of packages that are used inter- with format requirements of paragraph

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(d) of this section to the maximum ex- (d)(5) of this section with quantitative tent possible, except that the identity amounts declared in columns aligned of each food shall be specified to the under the column headings set forth in right of the ‘‘Nutrition Facts’’ title, paragraph (e)(1) of this section. and both the quantitative amount by (3) Quantitative information by weight (i.e., g/mg amounts) and the weight required in paragraph (d)(7)(i) of percent Daily Value for each nutrient this section shall be specified for the shall be listed in separate columns form of the product as packaged and under the name of each food. according to the label serving size (14) When nutrition labeling appears based on the Reference Amount in in a second language, the nutrition in- § 381.412(b). formation may be presented in a sepa- (i) Quantitative information by rate nutrition label for each language weight may be included for other forms or in one nutrition label with the infor- of the product represented by the addi- mation in the second language fol- tional column(s) either immediately lowing that in English. Numeric char- adjacent to the required quantitative acters that are identical in both lan- information by weight for the product guages need not be repeated (e.g., as packaged and according to the label ‘‘Protein/Proteinas 2 g’’). All required serving size based on the Reference information must be included in both Amount in § 381.412(b) or as a footnote. languages. (A) If such additional quantitative (e) Nutrition information may be pre- information is given immediately adja- sented for two or more forms of the cent to the required quantitative infor- same product (e.g., both ‘‘raw’’ and mation, it shall be declared for all nu- ‘‘cooked’’) or for common combina- trients listed and placed immediately tions of foods as provided for in para- following and differentiated from the graph (b) of this section, or for dif- required quantitative information ferent units (e.g., per 100 grams) as pro- (e.g., separated by a comma). Such in- vided for in paragraph (b) of this sec- formation shall not be put in a sepa- tion, or for two or more groups for which RDI’s are established (e.g., both rate column. infants and children less than 4 years (B) If such additional quantitative in- of age) as provided for in paragraph formation is given in a footnote, it (c)(8)(i) of this section. When such dual shall be declared in the same order as labeling is provided, equal prominence the nutrients are listed in the nutri- shall be given to both sets of values. tion label. The additional quantitative Information shall be presented in a for- information may state the total nutri- mat consistent with paragraph (d) of ent content of the product identified in this section, except that: the second column or the nutrient (1) Following the subheading of amounts added to the product as pack- ‘‘Amount Per Serving,’’ there shall be aged for only those nutrients that are two or more column headings accu- present in different amounts than the rately describing the forms of the same amounts declared in the required quan- product (e.g., ‘‘raw’’ and ‘‘roasted’’), titative information. The footnote the combinations of foods, the units, or shall clearly identify which amounts the RDI groups that are being declared. are declared. Any subcomponents de- The column representing the product clared shall be listed parenthetically as packaged and according to the label after principal components (e.g., 1⁄2 cup serving size based on the Reference skim milk contributes an additional 40 Amount in § 381.412(b) shall be to the calories, 65 mg sodium, 6 g total carbo- left of the numeric columns. hydrate (6 g sugars), and 4 g protein). (2) When the dual labeling is pre- (ii) Total fat and its quantitative sented for two or more forms of the amount by weight shall be followed by same product, for combinations of an asterisk (or other symbol) (e.g., foods, or for different units, total cal- ‘‘Total fat (2 g)*’’) referring to another ories and calories from fat (and cal- asterisk (or symbol) at the bottom of ories from saturated fat, when de- the nutrition label identifying the clared) shall be listed in a column and form(s) of the product for which quan- indented as specified in paragraph titative information is presented.

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(f)(1) Nutrition information may be (i.e., calories, total fat, sodium, total presented in a simplified format as set carbohydrate, and protein), are present forth herein when any required nutri- in insignificant amounts. An insignifi- ents, other than the core nutrients cant amount shall be defined as that

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amount that may be rounded to zero in (g) Foods in packages that have a nutrition labeling, except that for total total surface area available to bear la- carbohydrate, dietary fiber, sugars and beling of 40 or less square inches may protein, it shall be an amount less than modify the requirements of paragraphs 1 gram. (c) through (f) of this section and (2) The simplified format shall in- § 381.402(a) by one or more of the fol- clude information on the following nu- lowing means: trients: (1)(i) Presenting the required nutri- (i) Total calories, total fat, total car- tion information in a tabular or linear bohydrate, sodium, and protein; (i.e., string) fashion, rather than in (ii) Any of the following that are vertical columns if the product has a present in more than insignificant total surface area available to bear la- amounts: Calories from fat, saturated beling of less than 12 square inches, or fat, cholesterol, dietary fiber, sugars, if the product has a total surface area vitamin A, vitamin C, calcium, and available to bear labeling of 40 or less iron; and square inches and the package shape or (iii) Any vitamins and minerals list- size cannot accommodate a standard ed in paragraph (c)(8)(iv) of this section vertical column or tabular display on when they are added in fortified or fab- any label panel. Nutrition information ricated foods. may be given in a linear fashion only if (3) Other nutrients that are naturally the package shape or size will not ac- present in the product in more than in- commodate a tabular display. significant amounts may be volun- (ii) When nutrition information is tarily declared as part of the simplified given in a linear display, the nutrition format. information shall be set off in a box by (4) Any required nutrient, other than the use of a hairline. The percent Daily a core nutrient, that is present in an Value is separated from the quan- insignificant amount may be omitted titative amount declaration by the use from the tabular listing, provided that of parenthesis, and all nutrients, both the following statement is included at principal components and subcompo- the bottom of the nutrition label, ‘‘Not nents, are treated similarly. Bolding is a significant source of llll.’’ The required only on the title ‘‘Nutrition blank shall be filled in with the appro- Facts’’ and is allowed for nutrient priate nutrient or food component. Al- names for ‘‘Calories,’’ ‘‘Total fat,’’ ternatively, amounts of vitamins and ‘‘Cholesterol,’’ ‘‘Sodium,’’ ‘‘Total car- minerals present in insignificant bohydrate,’’ and ‘‘Protein.’’ amounts may be declared by the use of (2) Using any of the following abbre- an asterisk (or symbol) that is placed viations: at the bottom of the table of nutrient values and that is followed by the Serving size—Serv size Servings per container—Servings statement ‘‘Contains less than 2 per- Calories from fat—Fat cal cent of the Daily Value of this (these) Calories from saturated fat—Sat fat cal nutrient (nutrients).’’ Saturated fat—Sat fat (5) Except as provided for in para- Monounsaturated fat—Monounsat fat graph (g) of this section and in Polyunsaturated fat—Polyunsat fat § 381.500(c) and (d), nutrient informa- Cholesterol—Cholest tion declared in the simplified format Total carbohydrate—Total carb shall be presented in the same manner Dietary fiber—Fiber as specified in paragraphs (d) or (e) of Soluble fiber—Sol fiber this section, except that the footnote Insoluble fiber—Insol fiber required in paragraph (d)(9) of this sec- Sugar alcohol—Sugar alc tion is not required. When the footnote Other carbohydrate—Other carb is omitted, an asterisk shall be placed (3) Omitting the footnote required in at the bottom of the label followed by paragraph (d)(9) of this section and the statement ‘‘Percent Daily Values placing another asterisk at the bottom are based on a 2,000 calorie diet’’ and, if of the label followed by the statement the term ‘‘Daily Value’’ is not spelled ‘‘Percent Daily Values are based on a out in the heading, a statement that 2,000 calorie diet’’ and, if the term ‘‘DV’’ represents ‘‘Daily Value.’’ ‘‘Daily Value’’ is not spelled out in the

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heading, a statement that ‘‘DV’’ rep- available for inspection at the National resents ‘‘Daily Value.’’ Archives and Records Administration (4) Presenting the required informa- (NARA). For information on the avail- tion on any other label panel. ability of this material at NARA, call (h) Compliance with this section 202–741–6030, or go to: http:// shall be determined as follows: www.archives.gov/federallregister/ (1) A production lot is a set of food codeloflfederallregulations/ production consumer units that are ibrllocations.html. from one production shift. Alter- (3) Two classes of nutrients are de- natively, a collection of consumer fined for purposes of compliance: units of the same size, type, and style (i) Class I. Added nutrients in for- produced under conditions as nearly tified or fabricated foods; and uniform as possible, designated by a (ii) Class II. Naturally occurring (in- common container code or marking, digenous) nutrients. If any ingredient constitutes a production lot. which contains a naturally occurring (2) The sample for nutrient analysis (indigenous) nutrient is added to a shall consist of a composite of a min- food, the total amount of such nutrient imum of six consumer units, each from in the final food product is subject to a production lot. Alternatively, the Class II requirements unless the same sample for nutrient analysis shall con- nutrient is also added, which would sist of a composite of a minimum of six make the total amount of such nutri- consumer units, each randomly chosen ent subject to Class I requirements. to be representative of a production (4) A product with a label declaration lot. In each case, the units may be indi- of a vitamin, mineral, protein, total vidually analyzed and the results of the carbohydrate, dietary fiber, other car- analyses averaged, or the units would bohydrate, polyunsaturated or be composited and the composite ana- monounsaturated fat, or potassium lyzed. In both cases, the results, wheth- shall be deemed to be misbranded er an average or a single result from a under section 4(h) of the Poultry Prod- composite, will be considered by the ucts Inspection Act (21 U.S.C. 453(h)(4)) Agency to be the nutrient content of a unless it meets the following require- composite. All analyses shall be per- ments: formed by appropriate methods and (i) Class I vitamin, mineral, protein, procedures used by the Department for dietary fiber, or potassium. The nutri- each nutrient in accordance with the ent content of the composite is at least ‘‘Chemistry Laboratory Guidebook,’’ equal to the value for that nutrient de- or, if no USDA method is available and clared on the label. appropriate for the nutrient, by appro- (ii) Class II vitamin, mineral, propriate methods for the nutrient in ac- tein, total carbohydrate, dietary fiber, cordance with the 1990 edition of the other carbohydrate, polyunsaturated ‘‘Official Methods of Analysis’’ of the or monounsaturated fat, or potassium. AOAC International, formerly Associa- The nutrient content of the composite tion of Official Analytical Chemists, is at least equal to 80 percent of the 15th ed., which is incorporated by ref- value for that nutrient declared on the erence, unless a particular method of label; Provided, That no regulatory ac- analysis is specified in § 381.409(c), or, if tion will be based on a determination no USDA, AOAC, or specified method is of a nutrient value which falls below available and appropriate, by other re- this level by an amount less than the liable and appropriate analytical pro- variability generally recognized for the cedures as so determined by the Agen- analytical method used in that product cy. The ‘‘Official Methods of Analysis’’ at the level involved, and inherent nu- is incorporated as it exists on the date trient variation in a product. of approval. This incorporation by ref- (5) A product with a label declaration erence was approved by the Director of of calories, sugars, total fat, saturated the Federal Register in accordance fat, cholesterol, or sodium shall be with 5 U.S.C. 552(a) and 1 CFR part 51. deemed to be misbranded under section Copies may be purchased from the 4(h) of the Poultry Products Inspection AOAC International, 2200 Wilson Blvd., Act (21 U.S.C. 453(h)(4)) if the nutrient Suite 400, Arlington, VA 22201. It is also content of the composite is greater

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than 20 percent in excess of the value of servings per container need not be infor that nutrient declared on the label; cluded in nutrition labeling of single-ingre- Provided, That no regulatory action dient, raw poultry products that are not will be based on a determination of a ground or chopped poultry products de- nutrient value which falls above this scribed in § 381.401, including those that have level by an amount less than the varia- been previously frozen.’’; bility generally recognized for the ana- c. Amend paragraph (b)(11) by adding the lytical method used in that product at phrase ‘‘single-ingredient, raw products that are not ground or chopped poultry products the level involved, and inherent nutri- described in § 381.401 and’’ after ‘‘exception ent variation in a product. of’’; (6) The amount of a vitamin, mineral, d. Amend paragraph (d)(3)(ii) by removing protein, total carbohydrate, dietary the period and adding ‘‘or on single-ingre- fiber, other carbohydrate, polyunsat- dient, raw poultry products that are not urated or monounsaturated fat, or po- ground or chopped poultry products de- tassium may vary over labeled scribed in § 381.401.’’ at the end of the para- amounts within good manufacturing graph; practice. The amount of calories, sug- e. Amend paragraph (e)(3) by adding ‘‘, but ars, total fat, saturated fat, choles- may be on the basis of ‘as consumed’ for sin- terol, or sodium may vary under la- gle-ingredient, raw poultry products that are beled amounts within good manufac- not ground or chopped poultry products de- turing practice. scribed in § 381.401,’’ after ‘‘as packaged’’; and (7) Compliance will be based on the f. Amend paragraph (h)(9) by adding, ‘‘that metric measure specified in the label are not ground or chopped poultry products statement of serving size. described in § 381.401’’ after ‘‘products’’, by (8) The management of the establish- removing the phrase, ‘‘its published form, ment must maintain records to support the Agriculture Handbook No. 8 series’’, and the validity of nutrient declarations by adding, in its place, ‘‘its released form, contained on product labels. Such the USDA National Nutrient Database for Standard Reference’’, and by removing the records shall be made available to the period and adding the following at the end of inspector or any duly authorized rep- the paragraph: ‘‘, as provided in § 381.445(e) resentative of the Agency upon re- and (f).’’ quest. For the convenience of the user, the re- (9) The compliance provisions set vised text is set forth as follows: forth in paragraph (h)(1) through (8) of this section shall not apply to single- § 381.409 Nutrition label content. ingredient, raw poultry products, including those that have been pre- * * * * * viously frozen, when nutrition labeling is based on the most current represent- (b) * * * ative data base values contained in (3) The declaration of nutrient and food USDA’s National Nutrient Data Bank component content shall be on the basis of the product ‘‘as packaged’’ for all products, or its published form, the Agriculture except that single-ingredient, raw products Handbook No. 8 series. that are not ground or chopped poultry prod- (Paperwork requirements were approved by ucts as described in § 381.401 may be declared the Office of Management and Budget under on the basis of the product ‘‘as consumed.’’ control number 0583–0088.) For single-ingredient, raw products that are not ground or chopped poultry products de- [58 FR 675, Jan. 6, 1993; 58 FR 43788, Aug. 18, scribed in § 381.401, if data are based on the 1993, as amended at 58 FR 47628, Sept. 10, product ‘‘as consumed,’’ the data must be 1993; 59 FR 45196, Sept. 1, 1994; 60 FR 197, Jan. presented in accordance with § 381.445(d). In 3, 1995; 60 FR 10304, Feb. 24, 1995; 69 FR 58802, addition to the required declaration on the Oct. 1, 2004] basis of ‘‘as packaged’’ for products other EFFECTIVE DATE NOTE: At 75 FR 82166, Dec. than single-ingredient, raw products that are 29, 2010, § 381.409 was amended as follows, ef- not ground or chopped poultry products as fective Jan. 1, 2012. At 76 FR 76890, Dec. 9, described in § 381.401, the declaration may 2011, the effectiveness was delayed until Mar. also be made on the basis of ‘‘as consumed,’’ 1, 2012. provided that preparation and cooking in- a. Revise paragraph (b)(3); structions are clearly stated. b. Amend paragraph (b)(10) by adding the following new sentence at the end of the paragraph: ‘‘The declaration of the number * * * * *

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§§ 381.410–381.411 [Reserved] (iii) Serving sizes used by manufacturers and grocers; and § 381.412 Reference amounts custom- (iv) Serving sizes used by other coun- arily consumed per eating occasion. tries. (a) The general principles followed in (6) Because they reflect the amount arriving at the reference amounts cus- customarily consumed, the Reference tomarily consumed per eating occasion Amount and, in turn, the serving size (Reference Amount(s)), as set forth in declared on the product label are based paragraph (b) of this section, are: on only the edible portion of food, and (1) The Reference Amounts are cal- not bone, seed, shell, or other inedible culated for persons 4 years of age or components. older to reflect the amount of food cus- (7) The Reference Amount is based on tomarily consumed per eating occasion the major intended use of the product by persons in this population group. (e.g., a mixed dish measurable with a These Reference Amounts are based on cup as a main dish and not as a side data set forth in appropriate national dish). food consumption surveys. (8) The Reference Amounts for prod- (2) The Reference Amounts are cal- ucts that are consumed as an ingre- culated for an infant or child under 4 dient of other products, but that may years of age to reflect the amount of also be consumed in the form in which food customarily consumed per eating they are purchased (e.g., ground poul- occasion by infants up to 12 months of try), are based on use in the form pur- age or by children 1 through 3 years of chased. age, respectively. These Reference (9) FSIS sought to ensure that foods Amounts are based on data set forth in that have similar dietary usage, prod- appropriate national food consumption uct characteristics, and customarily surveys. Such Reference Amounts are consumed amounts have a uniform Ref- to be used only when the product is erence Amount. specially formulated or processed for (b) The following Product Categories use by an infant or by a child under 4 and Reference Amounts shall be used years of age. as the basis for determining serving (3) An appropriate national food con- sizes for specific products: sumption survey includes a large sample size representative of the demo- TABLE 1—REFERENCE AMOUNTS CUSTOMARILY graphic and socioeconomic characteris- CONSUMED PER EATING OCCASION—INFANT tics of the relevant population group AND TODDLER FOODS 1,2,3 and must be based on consumption Reference data under actual conditions of use. Product category amount (4) To determine the amount of food Infant & Toddler Foods: customarily consumed per eating occa- Dinner Dry Mix ...... 15 g sion, the mean, median, and mode of Dinner, ready-to-serve, strained type ...... 60 g the consumed amount per eating occa- Dinner, soups, ready-to-serve junior type ...... 110 g sion were considered. Dinner, stew or soup ready-to-serve toddlers 170 g (5) When survey data were insuffi- Plain poultry and poultry sticks, ready-to-serve 55 g cient, FSIS took various other sources 1 These values represent the amount of food customarily consumed per eating occasion and were primarily derived of information on serving sizes of food from the 1977–1978 and the 1987–1988 Nationwide Food into consideration. These other sources Consumption Surveys conducted by the U.S. Department of Agriculture. of information included: 2 Unless otherwise noted in the Reference Amount column, (i) Serving sizes used in dietary guid- the Reference Amounts are for the ready-to-serve or almost ready-to-serve form of the product (i.e., heat and serve). If not ance recommendations or rec- listed separately, the Reference Amount for the unprepared ommended by other authoritative sys- form (e.g., dehydrated cereal) is the amount required to make one Reference Amount of the prepared form. tems or organizations; 3 Manufacturers are required to convert the Reference Amount to the label serving size in a household measure (ii) Serving sizes recommended in most appropriate to their specific product using the proce- comments; dures established by the regulation.

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TABLE 2—REFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASION—GENERAL FOOD SUPPLY 1,2,3,4,5

Reference Amount Reference Amount Product category Ready-to-serve Ready-to-cook

Egg mixtures, (western style omelet, souffle, egg foo young with poul- 110 g n/a try). Salad and potato toppers; e.g., poultry bacon bits ...... 7 g n/a Bacon; e.g., poultry breakfast strips...... 15 g 26 g = bacon. 18 g = breakfast strips Dried; e.g., poultry jerky, dried poultry, poultry sausage products with a 30 g n/a moisture/protein ratio of less than 2:1. Snacks; e.g., poultry snack food sticks ...... 30 g n/a Luncheon products, poultry bologna, poultry Canadian style bacon, 55 g n/a poultry crumbles, poultry luncheon loaf, potted poultry products, poultry taco filings. Linked poultry sausage products, poultry franks, poultry Polish sausage, 55 g n/a smoked or pickled poultry meat, poultry smoked sausage. 69 g = uncooked sausage. Entrees without sauce, poultry cuts, ready to cook poultry cuts, includ- 85 g 114g ing marinated, tenderized, injected cuts of poultry, poultry corn dogs, poultry croquettes, poultry fritters, cured poultry ham products, adult pureed poultry. Canned poultry, canned chicken, canned 4 turkey ...... 55 g n/a Entrees with sauce, turkey and gravy ...... 140 g n/a Mixed dishes NOT measurable with a cup; 5 e.g., poultry burrito, poultry 140 g (plus 55 g for prod- n/a enchiladas, poultry pizza, poultry quiche, all types of poultry sand- ucts toppings) wiches, cracker and poultry lunch-type packages, poultry gyro, poultry stromboli, poultry frank on a bun, poultry burger on a bun, poultry taco, chicken cordon bleu, poultry calzone, stuffed vegetables with poultry, poultry kabobs. Mixed dishes, measurables with a cup; e.g., poultry casserole, maca- 1 cup n/a roni and cheese with poultry, poultry pot pie, poultry spaghetti with sauce, poultry chili, poultry chili with beans, poultry hash, creamed dried poultry, poultry ravioli in sauce, poultry a la king, poultry stew, poultry goulash, poultry lasagna, poultry-filled pasta. Salads—pasta or potato, potato salad with poultry, macaroni and poul- 140 g n/a try salad. Salads—all other, poultry salads, chicken salad, turkey salad ...... 100 g n/a Soups—all varieties ...... 245 g n/a Major main entree type sauce; e.g., spaghetti sauce with poultry ...... 125 g n/a Minor main entree sauce; e.g., pizza sauce with poultry, gravy ...... 1⁄4 cup n/a Seasoning mixes dry, freeze dry, dehydrated, concentrated soup mixes, bases, extracts, dried broths and stock/juice, freeze dry trail mix products with poultry. As reconstituted: Amount to make one Reference Amount of the final dish; e.g.— Gravy ...... 1⁄4 cup n/a Major main entree type sauce ...... 125 g n/a Soup ...... 245 g n/a Entree measurable with a cup ...... 1 cup n/a 1 These values represent the amount of food customarily consumed per eating occasion and were primarily derived from the 1977–78 and the 1987–88 Nationwide Food Consumption Surveys conducted by the U.S. Department of Agriculture. 2 Manufacturers are required to convert the Reference Amounts to the label serving size in a household measure most appropriate to their specific product using the procedures established by regulation. 3 Examples listed under Product Category are not all inclusive or exclusive. Examples are provided to assist manufacturers in identifying appropriate product Reference Amount. 4 If packed or canned in liquid, the Reference Amount is for the drained solids, except for products in which both the solids and liquids are customarily consumed. 5 Pizza sauce is part of the pizza and is not considered to be a sauce topping.

(c) For products that have no Ref- be determined using the following erence Amount listed in paragraph (b) rules: of this section for the unprepared or (1) For bulk products, the Reference the prepared form of the product and Amount for the combined product shall that consist of two or more foods pack- be the Reference Amount, as estab- aged and presented to be consumed to- lished in paragraph (b) of this section, gether (e.g., poultry lunch meat with for the ingredient that is represented cheese and crackers), the Reference Amount for the combined product shall

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as the main ingredient plus propor- (f) The Reference Amounts set forth tioned amounts of all minor ingredi- in paragraphs (b) through (e) of this ents. section shall be used in determining (2) For products where the ingredient whether a product meets the criteria represented as the main ingredient is for nutritional claims. If the serving one or more discrete units, the Ref- size declared on the product label dif- erence Amount for the combined prod- fers from the Reference Amount, and uct shall be either the number of small the product meets the criteria for the discrete units or the fraction of the claim only on the basis of the Ref- large discrete unit that is represented erence Amount, the claim shall be fol- as the main ingredient that is closest lowed by a statement that sets forth to the Reference Amount for that in- the basis on which the claim is made. gredient as established in paragraph (b) That statement shall include the Ref- of this section plus proportioned erence Amount as it appears in para- amounts of all minor ingredients. graph (b) of this section followed, in (3) If the Reference Amounts are in parenthesis, by the amount in common compatible units, they shall be household measure if the Reference summed (e.g., ingredients in equal vol- Amount is expressed in measures other umes such as tablespoons). If the Ref- than common household measures. erence Amounts are in incompatible (g) The Administrator, on his or her units, the weights of the appropriate own initiative or on behalf of any in- volumes should be used (e.g., grams of terested person who has submitted a one ingredient plus gram weight of ta- labeling application, may issue a pro- blespoons of a second ingredient). posal to establish or amend a Product (d) If a product requires further prep- Category or Reference Amount identi- aration, e.g., cooking or the addition of fied in paragraph (b) of this section. water or other ingredients, and if para- (1) Labeling applications and sup- graph (b) of this section provides a Ref- porting documentation to be filed erence Amount for the product in the under this section shall be submitted prepared form, then the Reference in quadruplicate, except that the sup- Amount for the unprepared product porting documentation may be sub- shall be determined using the following rules: mitted on a computer disc copy. If any part of the material submitted is in a (1) Except as provided for in para- foreign language, it shall be accom- graph (d)(2) of this section, the Ref- panied by an accurate and complete erence Amount for the unprepared product shall be the amount of the un- English translation. The labeling appli- prepared product required to make the cation shall state the applicant’s post Reference Amount for the prepared office address. product as established in paragraph (b) (2) Pertinent information will be con- of this section. sidered as part of an application on the (2) For products where the entire basis of specific reference to such infor- contents of the package is used to pre- mation submitted to and retained in pare one large discrete unit usually di- the files of the Food Safety and Inspec- vided for consumption, the Reference tion Service. However, any reference to Amount for the unprepared product unpublished information furnished by a shall be the amount of the unprepared person other than the applicant will product required to make the fraction not be considered unless use of such in- of the large discrete unit closest to the formation is authorized (with the un- Reference Amount for the prepared derstanding that such information may product as established in paragraph (b) in whole or part be subject to release of this section. to the public) in a written statement (e) The Reference Amount for an imi- signed by the person who submitted it. tation or substitute product or altered Any reference to published information product as defined in § 381.413(d), such should be accompanied by reprints or as a ‘‘low calorie’’ version, shall be the photostatic copies of such references. same as for the product for which it is (3) The availability for public disclo- offered as a substitute. sure of labeling applications, along

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with supporting documentation, sub- (vii) The population group for which the mitted to the Agency under this sec- product will be offered for use (e.g., infants, tion will be governed by the rules spec- children under 4 years of age); ified in subchapter D, title 9. (viii) The names of the most closely-related products (or in the case of foods for (4) Data accompanying the labeling special dietary use and imitation or sub- application, such as food consumption stitute foods, the names of the products for data, shall be submitted on separate which they are offered as substitutes); sheets, suitably identified. If such data (ix) The suggested Reference Amount (the has already been submitted with an amount of edible portion of food as con- earlier labeling application from the sumed, excluding bone, skin or other inedible applicant, the present labeling applica- components) for the population group for tion must provide the data. which the product is intended with full description of the methodology and procedures (5) The labeling application must be that were used to determine the suggested signed by the applicant or by his or her Reference Amount. In determining the Ref- attorney or agent, or (if a corporation) erence Amount, general principles and fac- by an authorized official. tors in paragraph (a) of this section should (6) The labeling application shall in- be followed. clude a statement signed by the person (x) The suggested Reference Amount shall be expressed in metric units. Reference responsible for the labeling applica- Amounts for foods shall be expressed in tion, that to the best of his or her grams except when common household units knowledge, it is a representative and such as cups, tablespoons, and teaspoons are balanced submission that includes un- more appropriate or are more likely to pro- favorable information, as well as favor- mote uniformity in serving sizes declared on able information, known to him or her product labels. For example, common house- pertinent to the evaluation of the la- hold measures would be more appropriate if beling application. products within the same category differ substantially in density such as mixed dishes (7) Labeling applications for a new measurable with a cup. Reference Amount and/or Product Cat- (A) In expressing the Reference Amount in egory shall be accompanied by the fol- grams, the following general rules shall be lowing data which shall be submitted followed: in the following form to the Director, (1) For quantities greater than 10 grams, Food Labeling Division, Regulatory the quantity shall be expressed in nearest 5 Programs, Food Safety and Inspection grams increment. Service, Washington, DC 20250: (2) For quantities less than 10 grams, exact gram weights shall be used. llllllllllllllllllllllll (B) [Reserved] (Date) (xi) A labeling application for a new subcategory of food with its own Reference The undersigned, llllll submits this Amount shall include the following addi- labeling application pursuant to 9 CFR tional information: 381.412 with respect to Reference Amount and/or Product Category. (A) Data that demonstrate that the new subcategory of food will be consumed in Attached hereto, in quadruplicate, or on a amounts that differ enough from the Ref- computer disc copy, and constituting a part erence Amount for the parent category to of this labeling application, are the fol- warrant a separate Reference Amount. Data lowing: must include sample size, and the mean, (i) A statement of the objective of the la- standard deviation, median, and modal con- beling application; sumed amount per eating occasion for the (ii) A description of the product; product identified in the labeling application (iii) A complete sample product label in- and for other products in the category. All cluding nutrition label, using the format es- data must be derived from the same survey tablished by regulation; data. (iv) A description of the form in which the (B) Documentation supporting the dif- product will be marketed; ference in dietary usage and product charac- (v) The intended dietary uses of the prod- teristics that affect the consumption size uct with the major use identified (e.g., tur- that distinguishes the product identified in key as a luncheon meat); the labeling application from the rest of the (vi) If the intended use is primarily as an products in the category. ingredient in other foods, list of foods or food (xii) In conducting research to collect or categories in which the product will be used process food consumption data in support of as an ingredient with information on the the labeling application, the following gen- prioritization of the use; eral guidelines should be followed.

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(A) Sampled population selected should be trator’s decision to deny the use of the representative of the demographic and socio- proposed Reference Amount and/or economic characteristics of the target popu- Product Category. lation group for which the food is intended. (i) If the applicant fails to accept the (B) Sample size (i.e., number of eaters) should be large enough to give reliable esti- determination of the Administrator mates for customarily consumed amounts. and files an answer and requests a (C) The study protocol should identify po- hearing, and the Administrator, after tential biases and describe how potential bi- review of the answer, determines the ases are controlled for or, if not possible to initial determination to be correct, the control, how they affect interpretation of re- Administrator shall file with the Hear- sults. ing Clerk of the Department the notifi- (D) The methodology used to collect or cation, answer, and the request for a process data including study design, sampling procedures, materials used (e.g., ques- hearing, which shall constitute the tionnaire, interviewer’s manual), procedures complaint and answer in the pro- used to collect or process data, methods or ceeding, which shall thereafter be con- procedures used to control for unbiased esti- ducted in accordance with the Depart- mates, and procedures used to correct for ment’s Uniform Rules of Practice. nonresponse, should be fully documented. (ii) The hearing shall be conducted (xiii) A statement concerning the feasi- before an administrative law judge bility of convening associations, corpora- with the opportunity for appeal to the tions, consumers, and other interested par- ties to engage in negotiated rulemaking to Department’s Judicial Officer, who develop a proposed rule. shall make the final determination for Yours very truly, the Secretary. Any such determination by the Secretary shall be conclusive Applicant lllllllllllllll unless, within 30 days after receipt of By lllllllllllllllllll notice of such final determination, the (Indicate authority) applicant appeals to the United States (8) Upon receipt of the labeling appli- Court of Appeals for the circuit in cation and supporting documentation, which the applicant has its principal the applicant shall be notified, in writ- place of business or to the United ing, of the date on which the labeling States Court of Appeals for the District application was received. Such notice of Columbia Circuit. shall inform the applicant that the la- (11) If the labeling application is not beling application is undergoing Agen- summarily denied by the Adminis- cy review and that the applicant shall trator, the Administrator shall publish subsequently be notified of the Agen- in the FEDERAL REGISTER a proposed cy’s decision to consider for further re- rule to amend the regulations to au- view or deny the labeling application. thorize the use of the Reference (9) Upon review of the labeling appli- Amount and/or Product Category. The cation and supporting documentation, proposal shall also summarize the la- the Agency shall notify the applicant, beling application, including where the in writing, that the labeling applica- supporting documentation can be re- tion is either being considered for fur- viewed. The Administrator’s proposed ther review or that it has been sum- rule shall seek comment from con- marily denied by the Administrator. sumers, the industry, consumer and in- (10) If the labeling application is dustry groups, and other interested summarily denied by the Adminis- persons on the labeling application and trator, the written notification shall the use of the proposed Reference state the reasons therefor, including Amount and/or Product Category. why the Agency has determined that After public comment has been re- the proposed Reference Amount and/or ceived and reviewed by the Agency, the Product Category is false or mis- Administrator shall make a determina- leading. The notification letter shall tion on whether the proposed Reference inform the applicant that the applicant Amount and/or Product Category shall may submit a written statement by be approved for use on the labeling of way of answer to the notification, and poultry products. that the applicant shall have the right (i) If the Reference Amount and/or to request a hearing with respect to Product Category is denied by the Ad- the merits or validity of the Adminis- ministrator, the Agency shall notify

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the applicant, in writing, of the basis § 381.413 Nutrient content claims; gen- for the denial, including the reason eral principles. why the Reference Amount and/or (a) This section applies to poultry Product Category on the labeling was products that are intended for human determined by the Agency to be false consumption and that are offered for or misleading. The notification letter sale. shall also inform the applicant that the (b) A claim which, expressly or by applicant may submit a written state- implication, characterizes the level of ment by way of answer to the notifica- a nutrient (nutrient content claim) of tion, and that the applicant shall have the type required in nutrition labeling the right to request a hearing with re- pursuant to § 381.409, may not be made spect to the merits or validity of the on a label or in labeling of that product Administrator’s decision to deny the unless the claim is made in accordance use of the proposed Reference Amount with the applicable provisions in this and/or Product Category. subpart. (A) If the applicant fails to accept (1) An expressed nutrient content the determination of the Adminis- claim is any direct statement about trator and files an answer and requests the level (or range) of a nutrient in the a hearing, and the Administrator, after product, e.g., ‘‘low sodium’’ or ‘‘con- review of the answer, determines the tains 100 calories.’’ initial determination to be correct, the (2) An implied nutrient content claim Administrator shall file with the Hear- is any claim that: ing Clerk of the Department the notifi- (i) Describes the product or an ingre- cation, answer, and the request for a dient therein in a manner that sug- hearing, which shall constitute the gests that a nutrient is absent or complaint and answer in the pro- present in a certain amount (e.g., ceeding, which shall thereafter be con- ‘‘high in oat bran’’); or ducted in accordance with the Depart- (ii) Suggests that the product, be- ment’s Uniform Rules of Practice. cause of its nutrient content, may be (B) The hearing shall be conducted useful in maintaining healthy dietary before an administrative law judge practices and is made in association with the opportunity for appeal to the with an explicit claim or statement Department’s Judicial Officer, who about a nutrient (e.g., ‘‘healthy, con- shall make the final determination for tains 3 grams (g) of fat’’). the Secretary. Any such determination (3) Except for claims regarding vita- by the Secretary shall be conclusive mins and minerals described in para- unless, within 30 days after receipt of graph (q)(3) of this section, no nutrient notice of such final determination, the content claims may be made on prod- applicant appeals to the United States ucts intended specifically for use by in- Court of Appeals for the circuit in fants and children less than 2 years of which the applicant has its principal age unless the claim is specifically pro- place of business or to the United vided for in subpart Y of this part. States Court of Appeals for the District (4) Reasonable variations in the spell- of Columbia. ing of the terms defined in applicable (ii) If the Reference Amount and/or provisions in this subpart and their Product Category is approved, the synonyms are permitted provided these Agency shall notify the applicant, in variations are not misleading (e.g., writing, and shall also publish in the ‘‘hi’’ or ‘‘lo’’). FEDERAL REGISTER a final rule amend- (c) Information that is required or ing the regulations to authorize the permitted by § 381.409 to be declared in use of the Reference Amount and/or nutrition labeling, and that appears as Product Category. part of the nutrition label, is not a nu- (Paperwork requirements were approved by trient content claim and is not subject the Office of Management and Budget under to the requirements of this section. If control number 0583–0088.) such information is declared elsewhere [58 FR 675, Jan. 6, 1993; 58 FR 43789, Aug. 18, on the label or in labeling, it is a nutri- 1993, as amended at 58 FR 47628, Sept. 10, ent content claim and is subject to the 1993; 59 FR 45198, Sept. 1, 1994; 60 FR 207, Jan. requirements for nutrient content 3, 1995] claims.

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(d) A ‘‘substitute’’ product is one identity and shall not be unduly promi- that may be used interchangeably with nent in type style compared to the another product that it resembles, i.e., statement of identity. that it is organoleptically, physically, (g) Labeling information required in and functionally (including shelf life) §§ 381.413, 381.454, 381.456, 381.460, 381.461, similar to, and that it is not nutrition- 381.462, and 381.480, whose type size is ally inferior to unless it is labeled as not otherwise specified, is required to an ‘‘imitation.’’ be in letters and/or numbers no less (1) If there is a difference in perform- than 1⁄16 inch in height, except as per- ance characteristics that materially mitted by § 381.500(d)(2). limits the use of the product, the prod- (h) [Reserved] uct may still be considered a substitute (i) Except as provided in § 381.409 or in if the label includes a disclaimer adja- paragraph (q)(3) of this section, the cent to the most prominent claim as label or labeling of a product may con- defined in paragraph (j)(2)(iii) of this tain a statement about the amount or section, informing the consumer of percentage of a nutrient if: such difference (e.g., ‘‘not rec- (1) The use of the statement on the ommended for frying’’). product implicitly characterizes the (2) This disclaimer shall be in easily level of the nutrient in the product and legible print or type and in a size no is consistent with a definition for a less than that required by § 381.121(c) claim, as provided in subpart Y of this for the net quantity of contents state- part, for the nutrient that the label ad- ment, except where the size of the dresses. Such a claim might be, ‘‘less claim is less than two times the re- than 10 g of fat per serving;’’ quired size of the net quantity of con- (2) The use of the statement on the tents statement, in which case the dis- product implicitly characterizes the claimer statement shall be no less than level of the nutrient in the product and one-half the size of the claim but no is not consistent with such a defini- smaller than 1⁄16-inch minimum height, tion, but the label carries a disclaimer except as permitted by § 381.500(d)(2). adjacent to the statement that the (e)(1) Because the use of a ‘‘free’’ or product is not ‘‘low’’ in or a ‘‘good ‘‘low’’ claim before the name of a prod- source’’ of the nutrient, such as ‘‘only uct implies that the product differs 200 milligrams (mg) sodium per serv- from other products of the same type ing, not a low sodium product.’’ The by virtue of its having a lower amount disclaimer must be in easily legible of the nutrient, only products that print or type and in a size no less than have been specially processed, altered, required by § 381.121(c) for the net quan- formulated, or reformulated so as to tity of contents, except where the size lower the amount of the nutrient in of the claim is less than two times the the product, remove the nutrient from required size of the net quantity of the product, or not include the nutri- contents statement, in which case the ent in the product, may bear such a disclaimer statement shall be no less claim (e.g., ‘‘low sodium chicken noo- than one-half the size of the claim but dle soup’’). no smaller than 1⁄16-inch minimum (2) Any claim for the absence of a nu- height, except as permitted by trient in a product, or that a product is § 381.500(d)(2); low in a nutrient when the product has (3) The statement does not in any not been specially processed, altered, way implicitly characterize the level of formulated, or reformulated to qualify the nutrient in the product and it is for that claim shall indicate that the not false or misleading in any respect product inherently meets the criteria (e.g., ‘‘100 calories’’ or ‘‘5 grams of and shall clearly refer to all products fat’’), in which case no disclaimer is re- of that type and not merely to the par- quired. ticular brand to which the labeling at- (4) ‘‘Percent fat free’’ claims are not taches (e.g., ‘‘chicken breast meat, a authorized by this paragraph. Such low sodium food’’). claims shall comply with § 381.462(b)(6). (f) A nutrient content claim shall be (j) A product may bear a statement in type size and style no larger than that compares the level of a nutrient in two times that of the statement of the product with the level of a nutrient

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in a reference product. These state- vided that the resulting labeling is in- ments shall be known as ‘‘relative ternally consistent (i.e., that the val- claims’’ and include ‘‘light,’’ ‘‘re- ues stated in the nutrition informa- duced,’’ ‘‘less’’ (or ‘‘fewer’’), and tion, the nutrient values in the accom- ‘‘more’’ claims. panying information, and the declara- (1) To bear a relative claim about the tion of the percentage of nutrient by level of a nutrient, the amount of that which the product has been modified nutrient in the product must be com- are consistent and will not cause con- pared to an amount of nutrient in an sumer confusion when compared), and appropriate reference product as speci- that the actual modification is at least fied in this paragraph (j). equal to the percentage specified in the (i)(A) For ‘‘less’’ (or ‘‘fewer’’) and definition of the claim. ‘‘more’’ claims, the reference product (2) For products bearing relative may be a dissimilar product within a claims: product category that can generally be (i) The label or labeling must state substituted for one another in the diet the identity of the reference product or a similar product. and the percent (or fraction) of the (B) For ‘‘light,’’ ‘‘reduced,’’ and amount of the nutrient in the reference ‘‘added’’ claims, the reference product product by which the nutrient has been shall be a similar product, and modified, (e.g., ‘‘50 percent less fat (ii)(A) For ‘‘light’’ claims, the ref- than ‘reference product’ ’’ or ‘‘1⁄3 fewer erence product shall be representative calories than ‘reference product’ ’’); and of the type of product that includes the (ii) This information shall be imme- product that bears the claim. The nu- diately adjacent to the most prominent trient value for the reference product claim in easily legible boldface print or shall be representative of a broad base type, in distinct contrast to other of products of that type; e.g., a value in printed or graphic matter, that is no a representative, valid data base; an less than that required by § 381.121(c) average value determined from the top for net quantity of contents, except three national (or regional) brands, a where the size of the claim is less than market basket norm; or, where its nu- two times the required size of the net trient value is representative of the quantity of contents statement, in product type, a market leader. Firms which case the referral statement shall using such a reference nutrient value be no less than one-half the size of the as a basis for a claim, are required to claim, but no smaller than 1⁄16-inch provide specific information upon minimum height, except as permitted which the nutrient value was derived, by § 381.500(d)(2). on request, to consumers and appro- (iii) The determination of which use priate regulatory officials. of the claim is in the most prominent (B) For relative claims other than location on the label or labeling will be ‘‘light,’’ including ‘‘less’’ and ‘‘more’’ made based on the following factors, claims, the reference product may be considered in order: the same as that provided for ‘‘light’’ in paragraph (j)(1)(ii)(A) of this section (A) A claim on the principal display or it may be the manufacturer’s reg- panel adjacent to the statement of ular product, or that of another manu- identity; facturer, that has been offered for sale (B) A claim elsewhere on the prin- to the public on a regular basis for a cipal display panel; substantial period of time in the same (C) A claim on the information panel; geographic area by the same business or entity or by one entitled to use its (D) A claim elsewhere on the label or trade name, provided the name of the labeling. competitor is not used on the labeling (iv) The label or labeling must also of the product. The nutrient values bear: used to determine the claim when com- (A) Clear and concise quantitative in- paring a single manufacturer’s product formation comparing the amount of to the labeled product shall be either the subject nutrient in the product per the values declared in nutrition label- labeled serving size with that in the ing or the actual nutrient values, pro- reference product; and

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(B) This statement shall appear adja- (i) Weighing at least 6 ounces per la- cent to the most prominent claim or to beled serving; and the nutrition information. (ii) Containing not less than 40 grams (3) A relative claim for decreased lev- of food, or combinations of foods, from els of a nutrient may not be made on two or more of the following four food the label or in labeling of a product if groups, except as noted in paragraph the nutrient content of the reference (m)(1)Iii)(E) of this section. product meets the requirement for a (A) Bread, cereal, rice, and pasta; ‘‘low’’ claim for that nutrient. (B) Fruits and vegetables; (k) The term ‘‘modified’’ may be used (C) Milk, yogurt, and cheese; in the statement of identity of a prod- (D) Meat, poultry, fish, dry beans, uct that bears a relative claim that eggs, and nuts; except that: complies with the requirements of this (E) These foods will not be sauces part, followed immediately by the (except for foods in the four food name of the nutrient whose content groups in paragraph (m)(1)(ii)(A) has been altered (e.g., ‘‘modified fat through (D) of this section, that are in ‘product’ ’’). This statement of identity the sauces), gravies, condiments, rel- must be immediately followed by the ishes, pickles, olives, jams, jellies, syr- comparative statement such as ‘‘con- ups, breadings, or garnishes; and tains 35 percent less fat than ‘reference (2) Is represented as, or is in a form product’ ’’ The label or labeling must commonly understood to be, a main also bear the information required by dish (e.g., not a beverage or a dessert). paragraph (j)(2) of this section in the Such representations may be made by manner prescribed. statements, photographs, or vignettes. (l) For purposes of making a claim, a (n) Nutrition labeling in accordance ‘‘meal-type’’ product will be defined as with § 381.409 shall be provided for any a product that: food for which a nutrient content claim (1) Makes a major contribution to the is made. diet by: (o) Compliance with requirements for (i) Weighing at least 10 ounces per la- nutrient content claims shall be in ac- beled serving; and cordance with § 381.409(h). (ii) Containing not less than three 40 (p)(1) Unless otherwise specified, the gram portions of food, or combinations reference amount customarily con- of foods, from two or more of the fol- sumed set forth in § 381.412(b) through lowing four food groups, except as (e) shall be used in determining wheth- noted in paragraph (l)(1)(ii)(E) of this er a product meets the criteria for a section: nutrient content claim. If the serving (A) Bread, cereal, rice, and pasta; size declared on the product label dif- (B) Fruits and vegetables; fers from the reference amount cus- (C) Milk, yogurt, and cheese; tomarily consumed, and the amount of (D) Meat, poultry, fish, dry beans, the nutrient contained in the labeled eggs, and nuts; except that: serving does not meet the maximum or (E) These foods will not be sauces minimum amount criterion in the defi- (except for foods in the four food nition for the descriptor for that nutri- groups in paragraph (l)(1)(ii)(A) ent, the claim shall be followed by the through (D) of this section, that are in criteria for the claim as required by the sauces), gravies, condiments, rel- § 381.412(f) (e.g., ‘‘very low sodium, 35 ishes, pickles, olives, jams, jellies, syr- mg or less per 55 grams’’). ups, breadings, or garnishes; and (2) The criteria for the claim shall be (2) Is represented as, or is in the form immediately adjacent to the most commonly understood to be, a break- prominent claim in easily legible print fast, lunch, dinner, meal, or entre`e. or type and in a size that is no less Such representations may be made by than that required by § 381.121(c) for net statements, photographs, or vignettes. quantity of contents, except where the (m) For purposes of making a claim, size of the claim is less than two times a ‘‘main-dish’’ product will be defined the required size of the net quantity of as a food that: contents statement, in which case the (1) Makes a major contribution to the criteria statement shall be no less than meal by: one-half the size of the claim but no

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smaller than 1/16-inch minimum the retailer provides nutrition labeling height, except as permitted by information for at least 90 percent of § 381.500(d)(2). the major cuts of single-ingredient, (q) The following exemptions apply: raw poultry products, listed in § 381.444, (1) Nutrient content claims that have that it sells, and if the nutrition label not been defined by regulation and that is consistent in content and format appear as part of a brand name that with the mandatory program, or nutri- was in use prior to November 27, 1991, tion information is displayed at point- may continue to be used as part of that of-purchase in an appropriate manner. brand name, provided they are not (c) To determine whether there is sig- false or misleading under section 4(h) nificant participation by retailers of the Act (21 U.S.C. 453(h)(4)). under the voluntary nutrition labeling (2) [Reserved] guidelines, FSIS will select a rep- (3) A statement that describes the resentative sample of companies allo- percentage of a vitamin or mineral in cated by type and size. the food, including foods intended spe- (d) FSIS will find that significant cifically for use by infants and children participation by food retailers exists if less than 2 years of age, in relation to at least 60 percent of all companies a Reference Daily Intake (RDI) as de- that are evaluated are participating in fined in § 381.409 may be made on the accordance with the guidelines. label or in the labeling of a food with- (e) FSIS will evaluate significant out a regulation authorizing such a participation of the voluntary program claim for a specific vitamin or mineral. every 2 years beginning in May 1995. (4) The requirements of this section (1) If significant participation is do not apply to infant formulas and found, the voluntary nutrition labeling medical foods, as described in 21 CFR guidelines shall remain in effect. 101.13(q)(4). (2) If significant participation is not (5) [Reserved] found, FSIS shall initiate rulemaking (6) Nutrient content claims that were to require nutrition labeling on those part of the name of a product that was products under the voluntary program. subject to a standard of identity as of November 27, 1991, are not subject to EFFECTIVE DATE NOTE: At 75 FR 82166, Dec. the requirements of paragraph (b) of 29, 2010, § 381.443 was removed, effective Jan. this section whether or not they meet 1, 2012. At 76 FR 76890, Dec. 9, 2011, the effec- the definition of the descriptive term. tiveness was delayed until Mar. 1, 2012. (7) Implied nutrient content claims § 381.444 Identification of major cuts may be used as part of a brand name, of poultry products. provided that the use of the claim has been authorized by FSIS. Labeling ap- The major cuts of single-ingredient, plications requesting approval of such raw poultry products are: Whole chick- a claim may be submitted pursuant to en (without neck and giblets), chicken § 381.469. breast, chicken wing, chicken drumstick, chicken thigh, whole turkey [58 FR 675, Jan. 6, 1993; 58 FR 43789, Aug. 18, (without necks and giblets; separate 1993, as amended at 58 FR 47628, Sept. 10, nutrient panels for white and dark 1993; 59 FR 40215, Aug. 8, 1994; 59 FR 45198, Sept. 1, 1994; 60 FR 208, Jan. 3, 1995; 69 FR meat permitted as an option), turkey 58802, Oct. 1, 2004] breast, turkey wing, turkey drumstick, and turkey thigh. §§ 381.414–381.442 [Reserved] § 381.445 Guidelines for voluntary nu- § 381.443 Significant participation for trition labeling of single-ingredient, voluntary nutrition labeling. raw products. (a) In evaluating significant partici- (a) Nutrition information on the cuts pation for voluntary nutrition labeling, of single-ingredient, raw poultry prod- FSIS will consider only the major cuts ucts, including those that have been of single-ingredient, raw poultry prod- previously frozen, shall be provided in ucts, as identified in § 381.444, including the following manner: those that have been previously frozen. (1) If a retailer or manufacturer (b) FSIS will judge a food retailer to chooses to provide nutrition informa- be participating at a significant level if tion on the label of these products,

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these products shall be subject to all (e) Nutrient data that are the most requirements of the mandatory nutri- current representative data base values tion labeling program, except that nu- contained in USDA’s National Nutrient trition labeling may be declared on the Data Bank or its published form, the basis of either ‘‘as consumed’’ or ‘‘as Agriculture Handbook No. 8 series, packaged.’’ In addition, the declaration may be used for nutrition labeling of of the number of servings per container single-ingredient, raw poultry prod- need not be included in nutrition label- ucts, including those that have been ing of single-ingredient, raw poultry previously frozen. These data may be products, including those that have composite data that reflect different been previously frozen. classes of turkey or other variables af- (2) A retailer may choose to provide fecting nutrient content. Alter- nutrition information at the point-of- natively, data that reflect specific purchase, such as by posting a sign, or classes or other variables may be used, by making the information readily except that if data are used on labels available in brochures, notebooks, or attached to a product which is labeled leaflet form in close proximity to the as to class of poultry or other vari- food. The nutrition labeling informa- ables, the data must represent the tion may also be supplemented by a product in the package when such data video, live demonstration, or other are contained in the representative media. If a nutrition claim is made on data base. When data are used on labels point-of-purchase materials all of the attached to a product, the data must requirements of the mandatory nutri- represent the edible poultry tissues tion labeling program apply. However, present in the package. if only nutrition information—and not (f) If the nutrition information is in a nutrition claim—is supplied on point- accordance with paragraph (e) of this of-purchase materials: section, a nutrition label or labeling (i) The requirements of the manda- will not be subject to the Agency com- tory nutrition labeling program apply, pliance review under § 381.409(h), unless but the nutrition information may be a nutrition claim is made on the basis supplied on an ‘‘as packaged’’ or ‘‘as of the representative data base values. consumed,’’ basis; (g) Retailers may use data bases that (ii) The listing of percent of Daily they believe reflect the nutrient con- Value for the nutrients (except vita- tent of single-ingredient, raw poultry mins and minerals specified in products, including those that have § 381.409(c)(8)) and footnote required by been previously frozen; however, such § 381.409(d)(9) may be omitted; and labeling shall be subject to the compli- (iii) The point-of-purchase materials ance procedures of paragraph (e) of this are not subject to any of the format re- section and the requirements specified quirements. in this subpart for the mandatory nu- (b) [Reserved] trition labeling program. (c) The declaration of nutrition infor- [58 FR 675, Jan. 6, 1993, as amended at 58 FR mation may be presented in a sim- 47628, Sept. 10, 1993; 60 FR 209, Jan. 3, 1995] plified format as specified in § 381.409(f) EFFECTIVE DATE NOTE: At 75 FR 82166, Dec. for the mandatory nutrition labeling 29, 2010, § 381.445 was amended as follows, ef- program. fective Jan. 1, 2012. At 76 FR 76890, Dec. 9, (d) The nutrition label data should be 2011, the effectiveness was delayed until Mar. based on either raw or cooked edible 1, 2012. portions of poultry cuts with skin. If a. Revise the section heading and para- data are based on cooked portions, the graph (a) and (c); methods used to cook the products b. Amend paragraph (d) by removing must be specified and should be those ‘‘should’’ and adding, in its place, ‘‘for prod- which do not add nutrients from other ucts covered in paragraphs (a)(1) and (a)(2) must’’; ingredients such as flour, breading, and c. Amend paragraph (e) by removing ‘‘its salt. Additional nutritional data may published form, the Agriculture Handbook be presented on an optional basis for No. 8 series’’ and by adding, in its place, ‘‘its the raw or cooked edible portions of released form, the USDA National Nutrient the skinless poultry meat. Database for Standard Reference.’’; and

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d. Amend paragraph (f) by adding ‘‘pro- §§ 381.446–381.453 [Reserved] vided’’ after ‘‘nutrition information is’’. For the convenience of the user, the re- § 381.454 Nutrient content claims for vised text is set forth as follows: ‘‘good source,’’ ‘‘high,’’ and ‘‘more.’’

§ 381.445 Nutrition labeling of single-ingre- (a) General requirements. Except as dient, raw poultry products that are not provided in paragraph (e) of this sec- ground or chopped products described in tion, a claim about the level of a nutri- § 381.401. ent in a product in relation to the Ref- (a)(1) Nutrition information on the major erence Daily Intake (RDI) or Daily Ref- cuts of single-ingredient, raw poultry prod- erence Value (DRV), established for ucts identified in § 381.444, including those that nutrient (excluding total carbo- that have been previously frozen, is required, hydrate) in § 381.409(c), may only be either on their label or at their point-of-pur- made on the label or in labeling of the chase, unless exempted under § 381.500. If nu- product if: trition information is presented on the label, (1) The claim uses one of the terms it must be provided in accordance with the defined in this section in accordance provisions of § 381.409. If nutrition information is presented at the point-of-purchase, it with the definition for that term; must be provided in accordance with the pro- (2) The claim is made in accordance visions of this section. with the general requirements for nu- (2) Nutrition information on single-ingre- trient content claims in § 381.413; and dient, raw poultry products that are not (3) The product for which the claim is ground or chopped poultry products de- made is labeled in accordance with scribed in § 381.401 and are not major cuts of § 381.409. single-ingredient, raw poultry products iden- (b) ‘‘High’’ claims. (1) The terms tified in § 381.444, including those that have ‘‘high,’’ ‘‘rich in,’’ or ‘‘excellent source been previously frozen, may be provided at of’’ may be used on the label or in la- their point-of-purchase in accordance with beling of products, except meal-type the provisions of this section or on their products as defined in § 381.413(l) and label, in accordance with the provisions of main-dish products as defined in § 381.409. § 381.413(m), provided that the product (3) A retailer may provide nutrition infor- contains 20 percent or more of the RDI mation at the point-of-purchase by various or the DRV per reference amount cus- methods, such as by posting a sign or by making the information readily available in tomarily consumed. brochures, notebooks, or leaflet form in (2) The terms defined in paragraph close proximity to the food. The nutrition la- (b)(1) of this section may be used on beling information may also be supple- the label or in labeling of a meal-type mented by a video, live demonstration, or product as defined in § 381.413(l) and other media. If a nutrition claim is made on main-dish product as defined in point-of-purchase materials, all of the for- § 381.413(m), provided that: mat and content requirements of § 381.409 (i) The product contains a food that apply. However, if only nutrition informa- meets the definition of ‘‘high’’ in para- tion—and not a nutrition claim—is supplied graph (b)(1) of this section; and on point-of-purchase materials, the require- (ii) The label or labeling clearly iden- ments of § 381.409 apply, provided, however: tifies the food that is the subject of the (i) The listing of percent of Daily Value for claim (e.g., ‘‘the serving of broccoli in the nutrients (except vitamins and minerals this meal is high in vitamin C’’). specified in § 381.409(c)(8)) and footnote required by § 381.409(d)(9) may be omitted; and (c) ‘‘Good Source’’ claims. (1) The (ii) The point-of-purchase materials are terms ‘‘good source,’’ ‘‘contains,’’ or not subject to any of the format require- ‘‘provides’’ may be used on the label or ments. in labeling of products, except meal- type products as described in § 381.413(l) and main-dish products as defined in * * * * * § 317.313(m), provided that the product (c) For the point-of-purchase materials, contains 10 to 19 percent of the RDI or the declaration of nutrition information may the DRV per reference amount custom- be presented in a simplified format as speci- arily consumed. fied in § 381.409(f). (2) The terms defined in paragraph (c)(1) of this section may be used on the * * * * * label or in labeling of a meal-type

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product as defined in § 381.413(l) and that of the reference product that it remain-dish product as defined in places is declared adjacent to the most § 381.413(m), provided that: prominent claim or to the nutrition in- (i) The product contains a food that formation (e.g., ‘‘fiber content of ‘ref- meets the definition of ‘‘good source’’ erence product’ is 1 g per serving; ‘this in paragraph (c)(1) of this section; and product’ contains 4 g per serving’’). (ii) The label or labeling clearly iden- (2) A relative claim using the terms tifies the food that is the subject of the ‘‘more’’ and ‘‘added’’ may be used on claim (e.g., ‘‘the serving of sweet pota- the label or in labeling to describe the toes in this meal is a good source of level of protein, vitamins, minerals, di- fiber’’). etary fiber, or potassium in meal-type (d) Fiber claims. (1) If a nutrient con- products as defined in § 381.413(l) and tent claim is made with respect to the main-dish products as defined in level of dietary fiber, i.e., that the § 381.413(m), provided that: product is high in fiber, a good source (i) The product contains at least 10 of fiber, or that the product contains percent more of the RDI or the DRV ‘‘more’’ fiber, and the product is not for protein, vitamins, minerals, dietary ‘‘low’’ in total fat as defined in fiber, or potassium (expressed as a per- § 381.462(b)(2) or, in the case of a meal- cent of the Daily Value) per 100 g of type product or in a main-dish product, product than an appropriate reference is not ‘‘low’’ in total fat as defined in product as described in § 381.413(j)(1); § 381.462(b)(3), then the labeling shall and disclose the level of total fat per la- (ii) As required in § 381.413(j)(2) for beled serving size (e.g., ‘‘contains 12 relative claims: grams (g) of fat per serving’’); and (A) The identity of the reference (2) The disclosure shall appear in im- product and the percent (or fraction) mediate proximity to such claim and that the nutrient is greater relative to be in a type size no less than one-half the RDI or DRV are declared in imme- the size of the claim. diate proximity to the most prominent (e) ‘‘More’’ claims. (1) A relative claim such claim (e.g., ‘‘contains 10 percent using the terms ‘‘more’’ and ‘‘added’’ more of the Daily Value for fiber per 3 may be used on the label or in labeling ounces (oz) than does ‘reference prod- to describe the level of protein, vita- uct’ ’’), and mins, minerals, dietary fiber, or potas- (B) Quantitative information com- sium in a product, except meal-type paring the level of the nutrient in the products as defined in § 381.413(l) and meal-type product or in a main-dish main-dish products as defined in product per specified weight with that § 381.413(m), provided that: of the reference product that it re- (i) The product contains at least 10 places is declared adjacent to the most percent more of the RDI or the DRV prominent claim or to the nutrition infor protein, vitamins, minerals, dietary formation (e.g., ‘‘fiber content of ‘ref- fiber, or potassium (expressed as a per- erence product’ is 2 g per 3 oz; ‘this cent of the Daily Value) per reference product’ contains 5 g per 3 oz’’). amount customarily consumed than an appropriate reference product as de- [60 FR 210, Jan. 3, 1995, as amended at 69 FR scribed in § 381.413(j)(1); and 58803, Oct. 1, 2004] (ii) As required in § 381.413(j)(2) for relative claims: § 381.455 [Reserved] (A) The identity of the reference product and the percent (or fraction) § 381.456 Nutrient content claims for ‘‘light’’ or ‘‘lite.’’ that the nutrient is greater relative to the RDI or DRV are declared in imme- (a) General requirements. A claim diate proximity to the most prominent using the terms ‘‘light’’ or ‘‘lite’’ to de- such claim (e.g., ‘‘contains 10 percent scribe a product may only be made on more of the Daily Value for fiber than the label or in labeling of the product ‘reference product’ ’’); and if: (B) Quantitative information com- (1) The claim uses one of the terms paring the level of the nutrient in the defined in this section in accordance product per labeled serving size with with the definition for that term;

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(2) The claim is made in accordance product meets the definition of ‘‘low with the general requirements for nu- fat’’ and ‘‘low calorie.’’ trient content claims in § 381.413; and (c)(1)(i) A product for which the ref- (3) The product for which the claim is erence product contains 40 calories or made is labeled in accordance with less and 3 g fat or less per reference § 381.409. amount customarily consumed may (b) ‘‘Light’’ claims. The terms ‘‘light’’ use the terms ‘‘light’’ or ‘‘lite’’ without or ‘‘lite’’ may be used on the label or in further qualification if it is reduced by labeling of products, except meal-type 50 percent or more in sodium content products as defined in § 381.413(l) and compared to the reference product; and main-dish products as defined in (ii) As required in § 381.413(j)(2) for § 381.413(m), without further qualifica- relative claims: tion, provided that: (A) The identity of the reference (1) If the product derives 50 percent product and the percent (or fraction) or more of its calories from fat, its fat that the sodium was reduced are de- content is reduced by 50 percent or clared in immediate proximity to the more per reference amount custom- most prominent such claim (e.g., ‘‘50 arily consumed compared to an appro- percent less sodium than the market priate reference product as described in leader’’); and § 381.413(j)(1); or (B) Quantitative information com- (2) If the product derives less than 50 paring the level of sodium per labeled percent of its calories from fat: serving size with that of the reference (i) The number of calories is reduced product it replaces is declared adjacent by at least one-third (331⁄3 percent) per to the most prominent claim or to the reference amount customarily con- nutrition information (e.g., ‘‘lite ‘this sumed compared to an appropriate ref- product’—500 milligrams (mg) sodium erence product as described in per serving; regular ‘reference prod- § 381.413(j)(1); or uct’—1,000 mg sodium per serving’’). (ii) Its fat content is reduced by 50 (2)(i) A product for which the ref- percent or more per reference amount erence product contains more than 40 customarily consumed compared to the calories or more than 3 g fat per ref- appropriate reference product as de- erence amount customarily consumed scribed in § 381.413(j)(1); and may use the terms ‘‘light in sodium’’ (3) As required in § 381.413(j)(2) for rel- or ‘‘lite in sodium’’ if it is reduced by ative claims: 50 percent or more in sodium content (i) The identity of the reference prod- compared to the reference product, pro- uct and the percent (or fraction) that vided that ‘‘light’’ or ‘‘lite’’ is pre- the calories and the fat were reduced sented in immediate proximity with are declared in immediate proximity to ‘‘in sodium’’ and the entire term is pre- the most prominent such claim (e.g., sented in uniform type size, style, ‘‘1⁄3 fewer calories and 50 percent less color, and prominence; and fat than the market leader’’); and (ii) As required in § 381.413(j)(2) for (ii) Quantitative information com- relative claims: paring the level of calories and fat con- (A) The identity of the reference tent in the product per labeled serving product and the percent (or fraction) size with that of the reference product that the sodium was reduced are de- that it replaces is declared adjacent to clared in immediate proximity to the the most prominent claim or to the nu- most prominent such claim (e.g., ‘‘50 trition information (e.g., ‘‘lite ‘this percent less sodium than the market product’—200 calories, 4 grams (g) fat; leader’’); and regular ‘reference product’—300 cal- (B) Quantitative information com- ories, 8 g fat per serving’’); and paring the level of sodium per labeled (iii) If the labeled product contains serving size with that of the reference less than 40 calories or less than 3 g fat product it replaces is declared adjacent per reference amount customarily con- to the most prominent claim or to the sumed, the percentage reduction for nutrition information (e.g., or ‘‘lite that nutrient need not be declared. ‘this product’—170 mg sodium per serv- (4) A ‘‘light’’ claim may not be made ing; regular ‘reference product’—350 mg on a product for which the reference per serving’’).

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(3) Except for meal-type products as clared in immediate proximity to the defined in § 381.413(l) and main-dish most prominent such claim; and products as defined in § 381.413(m), a (B) Quantitative information com- ‘‘light in sodium’’ claim may not be paring the level of sodium per labeled made on a product for which the ref- serving size with that of the reference erence product meets the definition of product it replaces is declared adjacent ‘‘low in sodium.’’ to the most prominent claim or to the (d)(1) The terms ‘‘light’’ or ‘‘lite’’ nutrition information. may be used on the label or in labeling (e) Except as provided in paragraphs of a meal-type product as defined in (b) through (d) of this section, the § 381.413(l) and main-dish product as de- terms ‘‘light’’ or ‘‘lite’’ may not be fined in § 381.413(m), provided that: used to refer to a product that is not (i) The product meets the definition of: reduced in fat by 50 percent, or, if ap- 1 (A) ‘‘Low in calories’’ as defined in plicable, in calories by ⁄3 or, when § 381.460(b)(3); or properly qualified, in sodium by 50 per- (B) ‘‘Low in fat’’ as defined in cent unless: § 381.462(b)(3); and (1) It describes some physical or (ii)(A) A statement appears on the organoleptic attribute of the product principal display panel that explains such as texture or color and the infor- whether ‘‘light’’ is used to mean ‘‘low mation (e.g., ‘‘light in color’’ or ‘‘light fat,’’ ‘‘low calories,’’ or both (e.g., in texture’’) so stated, clearly conveys ‘‘Light Delight, a low fat meal’’); and the nature of the product; and (B) The accompanying statement is (2) The attribute (e.g., ‘‘color’’ or no less than one-half the type size of ‘‘texture’’) is in the same style, color, the ‘‘light’’ or ‘‘lite’’ claim. and at least one-half the type size as (2)(i) The terms ‘‘light in sodium’’ or the word ‘‘light’’ and in immediate ‘‘lite in sodium’’ may be used on the proximity thereto. label or in labeling of a meal-type (f) If a manufacturer can dem- product as defined in § 381.413(l) and onstrate that the word ‘‘light’’ has main-dish product as defined in been associated, through common use, § 381.413(m), provided that the product with a particular product to reflect a meets the definition of ‘‘low in so- physical or organoleptic attribute to dium’’ as defined in § 381.461(b)(5)(i); the point where it has become part of and the statement of identity, such use of (ii) ‘‘Light’’ or ‘‘lite’’ and ‘‘in so- the term ‘‘light’’ shall not be consid- dium’’ are presented in uniform type size, style, color, and prominence. ered a nutrient content claim subject (3) The terms ‘‘light’’ or ‘‘lite’’ may to the requirements in this part. be used in the brand name of a product (g) The term ‘‘lightly salted’’ may be to describe the sodium content, pro- used on a product to which has been vided that: added 50 percent less sodium than is (i) The product is reduced by 50 per- normally added to the reference prod- cent or more in sodium content com- uct as described in § 381.413(j)(1)(i)(B) pared to the reference product; and (j)(1)(ii)(B), provided that if the (ii) A statement specifically stating product is not ‘‘low in sodium’’ as de- that the product is ‘‘light in sodium’’ fined in § 381.461(b)(4), the statement or ‘‘lite in sodium’’ appears: ‘‘not a low sodium food,’’ shall appear (A) Contiguous to the brand name; adjacent to the nutrition information and and the information required to accom- (B) In uniform type size, style, color, pany a relative claim shall appear on and prominence as the product name; the label or labeling as specified in and § 381.413(j)(2). (iii) As required in § 381.413(j)(2) for relative claims: [60 FR 210, Jan. 3, 1995, as amended at 69 FR (A) The identity of the reference 58803, Oct. 1, 2004] product and the percent (or fraction) that the sodium was reduced are de-

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§§ 381.457–381.459 [Reserved] uent containing an insignificant amount, as defined in § 381.409(f)(1), of § 381.460 Nutrient content claims for all nutrients per reference amount cus- calorie content. tomarily consumed, the per-50-g cri- (a) General requirements. A claim terion refers to the ‘‘as prepared’’ about the calorie or sugar content of a form). product may only be made on the label (ii) If the product meets these condi- or in labeling of the product if: tions without the benefit of special (1) The claim uses one of the terms processing, alteration, formulation, or defined in this section in accordance reformulation to lower the caloric con- with the definition for that term; tent, it is labeled to clearly refer to all (2) The claim is made in accordance products of its type and not merely to with the general requirements for nu- the particular brand to which the label trient content claims in § 381.413; and attaches. (3) The product for which the claim is (3) The terms defined in paragraph made is labeled in accordance with § 381.409. (b)(2) of this section may be used on (b) Calorie content claims. (1) The the label or in labeling of a meal-type terms ‘‘calorie free,’’ ‘‘free of calories,’’ product as defined in § 381.413(l) and ‘‘no calories,’’ ‘‘zero calories,’’ ‘‘with- main-dish product as defined in out calories,’’ ‘‘trivial source of cal- § 381.413(m), provided that: ories,’’ ‘‘negligible source of calories,’’ (i) The product contains 120 calories or ‘‘dietarily insignificant source of or less per 100 g of product; and calories’’ may be used on the label or (ii) If the product meets this condi- in labeling of products, provided that: tion without the benefit of special (i) The product contains less than 5 processing, alteration, formulation, or calories per reference amount custom- reformulation to lower the calorie con- arily consumed and per labeled serving tent, it is labeled to clearly refer to all size; and products of its type and not merely to (ii) If the product meets this condi- the particular brand to which it at- tion without the benefit of special taches. processing, alteration, formulation, or (4) The terms ‘‘reduced calorie,’’ ‘‘re- reformulation to lower the caloric con- duced in calories,’’ ‘‘calorie reduced,’’ tent, it is labeled to clearly refer to all ‘‘fewer calories,’’ ‘‘lower calorie,’’ or products of its type and not merely to ‘‘lower in calories’’ may be used on the the particular brand to which the label label or in labeling of products, except attaches. meal-type products as defined in (2) The terms ‘‘low calorie,’’ ‘‘few cal- § 381.413(l) and main-dish products as ories,’’ ‘‘contains a small amount of defined in § 318.413(m), provided that: calories,’’ ‘‘low source of calories,’’ or (i) The product contains at least 25 ‘‘low in calories’’ may be used on the percent fewer calories per reference label or in labeling of products, except amount customarily consumed than an meal-type products as defined in appropriate reference product as de- § 381.413(l) and main-dish products as scribed in § 381.413(j)(1); and defined in § 318.413(m), provided that: (i)(A) The product has a reference (ii) As required in § 381.413(j)(2) for amount customarily consumed greater relative claims: than 30 grams (g) or greater than 2 ta- (A) The identity of the reference blespoons (tbsp) and does not provide product and the percent (or fraction) more than 40 calories per reference that the calories differ between the two amount customarily consumed; or products are declared in immediate (B) The product has a reference proximity to the most prominent such amount customarily consumed of 30 g claim (e.g., lower calorie ‘product’—‘‘33 or less or 2 tbsp or less and does not 1⁄3 percent fewer calories than our reg- provide more than 40 calories per ref- ular ‘product’ ’’); and erence amount customarily consumed (B) Quantitative information com- and per 50 g (for dehydrated products paring the level of calories in the prod- that must be reconstituted before typ- uct per labeled serving size with that of ical consumption with water or a dil- the reference product that it replaces

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is declared adjacent to the most promi- product may not be labeled with such nent claim or to the nutrition informa- terms unless: tion (e.g., ‘‘calorie content has been re- (i) The product contains less than 0.5 duced from 150 to 100 calories per serv- g of sugars, as defined in ing’’). § 381.409(c)(6)(ii), per reference amount (iii) Claims described in paragraph customarily consumed and per labeled (b)(4) of this section may not be made serving size or, in the case of a meal- on the label or in labeling of products type product or a main-dish product, if the reference product meets the defi- less than 0.5 g of sugars per labeled nition for ‘‘low calorie.’’ serving size; (5) The terms defined in paragraph (ii) The product contains no ingre- (b)(4) of this section may be used on dient that is a sugar or that is gen- the label or in labeling of a meal-type erally understood by consumers to con- product as defined in § 381.413(l) and tain sugars unless the listing of the in- main-dish product as defined in gredient in the ingredients statement § 381.413(m), provided that: is followed by an asterisk that refers to (i) The product contains at least 25 the statement below the list of ingredi- percent fewer calories per 100 g of prod- ents, which states: ‘‘Adds a trivial uct than an appropriate reference prod- amount of sugar,’’ ‘‘adds a negligible uct as described in § 381.413(j)(1); and amount of sugar,’’ or ‘‘adds a dietarily (ii) As required in § 381.413(j)(2) for insignificant amount of sugar;’’ and relative claims: (iii)(A) It is labeled ‘‘low calorie’’ or (A) The identity of the reference ‘‘reduced calorie’’ or bears a relative product and the percent (or fraction) claim of special dietary usefulness la- that the calories differ between the two beled in compliance with paragraphs products are declared in immediate (b)(2), (b)(3), (b)(4), or (b)(5) of this sec- proximity to the most prominent such tion; or claim (e.g., ‘‘calorie reduced ‘product’, (B) Such term is immediately accom- 25% less calories per ounce (oz) (or 3 oz) panied, each time it is used, by either than our regular ‘product’ ’’); and the statement ‘‘not a reduced calorie (B) Quantitative information com- product,’’ ‘‘not a low calorie product,’’ paring the level of calories in the prod- or ‘‘not for weight control.’’ uct per specified weight with that of (2) The terms ‘‘no added sugar,’’ the reference product that it replaces ‘‘without added sugar,’’ or ‘‘no sugar is declared adjacent to the most promi- added’’ may be used only if: nent claim or to the nutrition informa- (i) No amount of sugars, as defined in tion (e.g., ‘‘calorie content has been re- § 381.409(c)(6)(ii), or any other ingre- duced from 110 calories per 3 oz to 80 dient that contains sugars that func- calories per 3 oz’’). tionally substitute for added sugars is (iii) Claims described in paragraph added during processing or packaging; (b)(5) of this section may not be made (ii) The product does not contain an on the label or in labeling of products ingredient containing added sugars if the reference product meets the defi- such as jam, jelly, or concentrated nition for ‘‘low calorie.’’ fruit juice; (c) Sugar content claims. (1) Terms (iii) The sugars content has not been such as ‘‘sugar free,’’ ‘‘free of sugar,’’ increased above the amount present in ‘‘no sugar,’’ ‘‘zero sugar,’’ ‘‘without the ingredients by some means such as sugar,’’ ‘‘sugarless,’’ ‘‘trivial source of the use of enzymes, except where the sugar,’’ ‘‘negligible source of sugar,’’ or intended functional effect of the proc- ‘‘dietarily insignificant source of ess is not to increase the sugars con- sugar’’ may reasonably be expected to tent of a product, and a functionally be regarded by consumers as terms insignificant increase in sugars results; that represent that the product con- (iv) The product that it resembles tains no sugars or sweeteners, e.g., and for which it substitutes normally ‘‘sugar free,’’ or ‘‘no sugar,’’ as indi- contains added sugars; and cating a product which is low in cal- (v) The product bears a statement ories or significantly reduced in cal- that the product is not ‘‘low calorie’’ ories. Consequently, except as provided or ‘‘calorie reduced’’ (unless the prod- in paragraph (c)(2) of this section, a uct meets the requirements for a ‘‘low’’

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or ‘‘reduced calorie’’ product) and that that the sugars differ between the two directs consumers’ attention to the nu- products are declared in immediate trition panel for further information proximity to the most prominent such on sugar and calorie content. claim (e.g., ‘‘reduced sugar ‘product’— (3) Paragraph (c)(1) of this section 25% less sugar than our regular ‘prod- shall not apply to a factual statement uct’ ’’); and that a product, including products in- (B) Quantitative information com- tended specifically for infants and chil- paring the level of the nutrient in the dren less than 2 years of age, is un- product per specified weight with that sweetened or contains no added sweet- of the reference product that it re- eners in the case of a product that con- places is declared adjacent to the most tains apparent substantial inherent prominent claim or to the nutrition in- sugar content, e.g., juices. formation (e.g., ‘‘sugar content has (4) The terms ‘‘reduced sugar,’’ ‘‘re- been reduced from 17 g per 3 oz to 13 g duced in sugar,’’ ‘‘sugar reduced,’’ ‘‘less per 3 oz’’). sugar,’’ ‘‘lower sugar,’’ or ‘‘lower in [60 FR 211, Jan. 3, 1995, as amended at 69 FR sugar’’ may be used on the label or in 58803, Oct. 1, 2004] labeling of products, except meal-type products as defined in § 381.413(l) and § 381.461 Nutrient content claims for main-dish products as defined in the sodium content. § 318.413(m), provided that: (a) General requirements. A claim (i) The product contains at least 25 about the level of sodium in a product percent less sugars per reference may only be made on the label or in la- amount customarily consumed than an beling of the product if: appropriate reference product as de- (1) The claim uses one of the terms scribed in § 381.413(j)(1); and defined in this section in accordance (ii) As required in § 381.413(j)(2) for with the definition for that term; relative claims: (2) The claim is made in accordance (A) The identity of the reference with the general requirements for nu- product and the percent (or fraction) trient content claims in § 381.413; and that the sugars differ between the two (3) The product for which the claim is products are declared in immediate made is labeled in accordance with proximity to the most prominent such § 381.409. claim (e.g., ‘‘this product contains 25 (b) Sodium content claims. (1) The percent less sugar than our regular terms ‘‘sodium free,’’ ‘‘free of sodium,’’ product’’); and ‘‘no sodium,’’ ‘‘zero sodium,’’ ‘‘without (B) Quantitative information com- sodium,’’ ‘‘trivial source of sodium,’’ paring the level of the sugar in the ‘‘negligible source of sodium,’’ or product per labeled serving size with ‘‘dietarily insignificant source of so- that of the reference product that it re- dium’’ may be used on the label or in places is declared adjacent to the most labeling of products, provided that: prominent claim or to the nutrition in- (i) The product contains less than 5 formation (e.g., ‘‘sugar content has milligrams (mg) of sodium per ref- been lowered from 8 g to 6 g per serv- erence amount customarily consumed ing’’). and per labeled serving size or, in the (5) The terms defined in paragraph case of a meal-type product or a main- (c)(4) of this section may be used on the dish product, less than 5 mg of sodium label or in labeling of a meal-type per labeled serving size; product as defined in § 381.413(l) and (ii) The product contains no ingre- main-dish product as defined in dient that is sodium chloride or is gen- § 381.413(m), provided that: erally understood by consumers to con- (i) The product contains at least 25 tain sodium unless the listing of the in- percent less sugars per 100 g of product gredient in the ingredients statement than an appropriate reference product is followed by an asterisk that refers to as described in § 381.413(j)(1); and the statement below the list of ingredi- (ii) As required in § 381.413(j)(2) for ents, which states: ‘‘Adds a trivial relative claims: amount of sodium,’’ ‘‘adds a negligible (A) The identity of the reference amount of sodium’’ or ‘‘adds a dietarily product and the percent (or fraction) insignificant amount of sodium;’’ and

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(iii) If the product meets these condi- small amount of sodium,’’ or ‘‘low tions without the benefit of special source of sodium’’ may be used on the processing, alteration, formulation, or label and in labeling of products, ex- reformulation to lower the sodium concept meal-type products as defined in tent, it is labeled to clearly refer to all § 381.413(l) and main-dish products as products of its type and not merely to defined in § 381.413(m), provided that: the particular brand to which the label (i)(A) The product has a reference attaches. amount customarily consumed greater (2) The terms ‘‘very low sodium’’ or than 30 g or greater than 2 tbsp and ‘‘very low in sodium’’ may be used on contains 140 mg or less sodium per ref- the label or in labeling of products, ex- erence amount customarily consumed; cept meal-type products as defined in or § 381.413(l) and main-dish products as (B) The product has a reference defined in § 381.413(m), provided that: amount customarily consumed of 30 g (i)(A) The product has a reference or less or 2 tbsp or less and contains 140 amount customarily consumed greater mg or less sodium per reference than 30 grams (g) or greater than 2 ta- amount customarily consumed and per blespoons (tbsp) and contains 35 mg or 50 g (for dehydrated products that must less sodium per reference amount cus- be reconstituted before typical con- tomarily consumed; or sumption with water or a diluent con- (B) The product has a reference taining an insignificant amount, as de- amount customarily consumed of 30 g fined in § 381.409(f)(1), of all nutrients or less or 2 tbsp or less and contains 35 per reference amount customarily con- mg or less sodium per reference sumed, the per-50-g criterion refers to amount customarily consumed and per the ‘‘as prepared’’ form); and 50 g (for dehydrated products that must (ii) If the product meets these condi- be reconstituted before typical con- tions without the benefit of special sumption with water or a diluent con- processing, alteration, formulation, or taining an insignificant amount, as de- reformulation to lower the sodium confined in § 381.409(f)(1), of all nutrients per reference amount customarily content, it is labeled to clearly refer to all sumed, the per-50-g criterion refers to products of its type and not merely to the ‘‘as prepared’’ form); and the particular brand to which the label (ii) If the product meets these condi- attaches. tions without the benefit of special (5) The terms defined in paragraph processing, alteration, formulation, or (b)(4) of this section may be used on reformulation to lower the sodium con- the label or in labeling of a meal-type tent, it is labeled to clearly refer to all product as defined in § 381.413(l) and products of its type and not merely to main-dish product as defined in the particular brand to which the label § 381.413(m), provided that: attaches. (i) The product contains 140 mg or (3) The terms defined in paragraph less sodium per 100 g of product; and (b)(2) of this section may be used on (ii) If the product meets these condi- the label or in labeling of a meal-type tions without the benefit of special product as defined in § 381.413(l) and processing, alteration, formulation, or main-dish product as defined in reformulation to lower the sodium con- § 381.413(m), provided that: tent, it is labeled to clearly refer to all (i) The product contains 35 mg or less products of its type and not merely to of sodium per 100 g of product; and the particular brand to which the label (ii) If the product meets this condi- attaches. tion without the benefit of special (6) The terms ‘‘reduced sodium,’’ processing, alteration, formulation, or ‘‘reduced in sodium,’’ ‘‘sodium re- reformulation to lower the sodium con- duced,’’ ‘‘less sodium,’’ ‘‘lower so- tent, it is labeled to clearly refer to all dium,’’ or ‘‘lower in sodium’’ may be products of its type and not merely to used on the label or in labeling of prod- the particular brand to which the label ucts, except meal-type products as de- attaches. fined in § 381.413(l) and main-dish prod- (4) The terms ‘‘low sodium,’’ ‘‘low in ucts as defined in § 381.413(m), provided sodium,’’ ‘‘little sodium,’’ ‘‘contains a that:

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(i) The product contains at least 25 (iii) Claims described in paragraph percent less sodium per reference (b)(7) of this section may not be made amount customarily consumed than an on the label or in labeling of products appropriate reference product as de- if the nutrient content of the reference scribed in § 381.413(j)(l); and product meets the definition for ‘‘low (ii) As required in § 381.413(j)(2) for sodium.’’ relative claims: (c) The term ‘‘salt’’ is not synony- (A) The identity of the reference mous with ‘‘sodium.’’ Salt refers to so- product and the percent (or fraction) dium chloride. However, references to that the sodium differs between the salt content such as ‘‘unsalted,’’ ‘‘no two products are declared in imme- salt,’’ ‘‘no salt added’’ are potentially diate proximity to the most prominent misleading. such claim (e.g., ‘‘reduced sodium (1) The term ‘‘salt free’’ may be used ‘product’, 50 percent less sodium than on the label or in labeling of products regular ‘product’ ’’); and only if the product is ‘‘sodium free’’ as (B) Quantitative information com- defined in paragraph (b)(1) of this sec- paring the level of sodium in the prod- tion. uct per labeled serving size with that of (2) The terms ‘‘unsalted,’’ ‘‘without the reference product that it replaces added salt,’’ and ‘‘no salt added’’ may is declared adjacent to the most promi- be used on the label or in labeling of nent claim or to the nutrition informa- products only if: tion (e.g., ‘‘sodium content has been (i) No salt is added during processing; lowered from 300 to 150 mg per serv- (ii) The product that it resembles and ing’’). for which it substitutes is normally (iii) Claims described in paragraph processed with salt; and (b)(6) of this section may not be made (iii) If the product is not sodium free, on the label or in labeling of a product the statement ‘‘not a sodium free prod- if the nutrient content of the reference uct’’ or ‘‘not for control of sodium in product meets the definition for ‘‘low the diet’’ appears adjacent to the nutri- sodium.’’ tion information of the product bearing (7) The terms defined in paragraph the claim. (b)(6) of this section may be used on (3) Paragraph (c)(2) of this section the label or in labeling of a meal-type shall not apply to a factual statement product as defined in § 381.413(l) and that a product intended specifically for main-dish product as defined in infants and children less than 2 years § 381.413(m), provided that: of age is unsalted, provided such state- (i) The product contains at least 25 ment refers to the taste of the product percent less sodium per 100 g of product and is not false or otherwise mis- than an appropriate reference product leading. as described in § 381.413(j)(l); and [60 FR 213, Jan. 3, 1995; 60 FR 5762, Jan. 30, (ii) As required in § 381.413(j)(2) for 1995, as amended at 69 FR 58803, Oct. 1, 2004] relative claims: (A) The identity of the reference § 381.462 Nutrient content claims for product and the percent (or fraction) fat, fatty acids, and cholesterol con- that the sodium differs between the tent. two products are declared in imme- (a) General requirements. A claim diate proximity to the most prominent about the level of fat, fatty acid, and such claim (e.g., ‘‘reduced sodium cholesterol in a product may only be ‘product’—30% less sodium per 3 oz made on the label or in labeling of than our ‘regular product’ ’’); and products if: (B) Quantitative information com- (1) The claim uses one of the terms paring the level of sodium in the prod- defined in this section in accordance uct per specified weight with that of with the definition for that term; the reference product that it replaces (2) The claim is made in accordance is declared adjacent to the most promi- with the general requirements for nu- nent claim or to the nutrition informa- trient content claims in § 381.413; and tion (e.g., ‘‘sodium content has been re- (3) The product for which the claim is duced from 220 mg per 3 oz to 150 mg made is labeled in accordance with per 3 oz’’). § 381.409.

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(b) Fat content claims. (1) The terms the per-50-g criterion refers to the ‘‘as ‘‘fat free,’’ ‘‘free of fat,’’ ‘‘no fat,’’ prepared’’ form). ‘‘zero fat,’’ ‘‘without fat,’’ ‘‘nonfat,’’ (ii) If the product meets these condi- ‘‘trivial source of fat,’’ ‘‘negligible tions without the benefit of special source of fat,’’ or ‘‘dietarily insignifi- processing, alteration, formulation, or cant source of fat’’ may be used on the reformulation to lower the fat content, label or in labeling of products, pro- it is labeled to clearly refer to all prod- vided that: ucts of its type and not merely to the (i) The product contains less than 0.5 particular brand to which the label at- gram (g) of fat per reference amount taches. customarily consumed and per labeled (3) The terms defined in paragraph serving size or, in the case of a meal- (b)(2) of this section may be used on type product or a main-dish product, the label or in labeling of a meal-type less than 0.5 g of fat per labeled serving product as defined in § 381.413(l) and size; main-dish product as defined in (ii) The product contains no added in- § 381.413(m), provided that: gredient that is a fat or is generally (i) The product contains 3 g or less of understood by consumers to contain total fat per 100 g of product and not fat unless the listing of the ingredient more than 30 percent of calories from in the ingredients statement is fol- fat; and lowed by an asterisk that refers to the (ii) If the product meets these condi- statement below the list of ingredients, tions without the benefit of special which states: ‘‘Adds a trivial amount of processing, alteration, formulation, or fat,’’ ‘‘adds a negligible amount of fat,’’ reformulation to lower the fat content, or ‘‘adds a dietarily insignificant it is labeled to clearly refer to all prod- amount of fat’’; and ucts of its type and not merely to the (iii) If the product meets these condi- particular brand to which the label at- tions without the benefit of special taches. processing, alteration, formulation, or (4) The terms ‘‘reduced fat,’’ ‘‘re- reformulation to lower the fat content, duced in fat,’’ ‘‘fat reduced,’’ ‘‘less fat,’’ it is labeled to clearly refer to all prod- ‘‘lower fat,’’ or ‘‘lower in fat’’ may be ucts of its type and not merely to the used on the label or in labeling of prod- particular brand to which the label at- ucts, except meal-type products as de- taches. fined in § 381.413(l) and main-dish prod- (2) The terms ‘‘low fat,’’ ‘‘low in fat,’’ ucts as defined in § 381.413(m), provided ‘‘contains a small amount of fat,’’ ‘‘low that: source of fat,’’ or ‘‘little fat’’ may be (i) The product contains at least 25 used on the label and in labeling of percent less fat per reference amount products, except meal-type products as customarily consumed than an appro- defined in § 381.413(l) and main-dish priate reference product as described in products as defined in § 381.413(m), pro- § 381.413(j)(1); and vided that: (ii) As required in § 381.413(j)(2) for (i)(A) The product has a reference relative claims: amount customarily consumed greater (A) The identity of the reference than 30 g or greater than 2 tablespoons product and the percent (or fraction) (tbsp) and contains 3 g or less of fat per that the fat differs between the two reference amount customarily con- products are declared in immediate sumed; or proximity to the most prominent such (B) The product has a reference claim (e.g., ‘‘reduced fat—50 percent amount customarily consumed of 30 g less fat than our regular ‘product’ ’’); or less or 2 tbsp or less and contains 3 and g or less of fat per reference amount (B) Quantitative information com- customarily consumed and per 50 g (for paring the level of fat in the product dehydrated products that must be re- per labeled serving size with that of the constituted before typical consumption reference product that it replaces is de- with water or a diluent containing an clared adjacent to the most prominent insignificant amount, as defined in claim or to the nutrition information § 381.409(f)(1), of all nutrients per ref- (e.g., ‘‘fat content has been reduced erence amount customarily consumed, from 8 g to 4 g per serving’’).

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(iii) Claims described in paragraph saturated fat,’’ ‘‘no saturated fat,’’ (b)(4) of this section may not be made ‘‘zero saturated fat,’’ ‘‘without satu- on the label or in labeling of a product rated fat,’’ ‘‘trivial source of saturated if the nutrient content of the reference fat,’’ ‘‘negligible source of saturated product meets the definition for ‘‘low fat,’’ or ‘‘dietarily insignificant source fat.’’ of saturated fat’’ may be used on the (5) The terms defined in paragraph label or in labeling of products, pro- (b)(4) of this section may be used on vided that: the label or in labeling of a meal-type (i) The product contains less than 0.5 product as defined in § 381.413(l) and g of saturated fat and less than 0.5 g main-dish product as defined in trans fatty acids per reference amount § 381.413(m), provided that: customarily consumed and per labeled (i) The product contains at least 25 serving size or, in the case of a meal- percent less fat per 100 g of product type product or a main-dish product, than an appropriate reference product less than 0.5 g of saturated fat and less as described in § 381.413(j)(1); and than 0.5 g trans fatty acids per labeled (ii) As required in § 381.413(j)(2) for serving size; relative claims: (ii) The product contains no ingre- (A) The identity of the reference dient that is generally understood by product and the percent (or fraction) consumers to contain saturated fat un- that the fat differs between the two less the listing of the ingredient in the products are declared in immediate ingredients statement is followed by an proximity to the most prominent such asterisk that refers to the statement claim (e.g., ‘‘reduced fat ‘product’, 33 below the list of ingredients, which percent less fat per 3 oz than our reg- states: ‘‘Adds a trivial amount of satu- ular ‘product’ ’’); and rated fat,’’ ‘‘adds a negligible amount (B) Quantitative information com- of saturated fat,’’ or ‘‘adds a dietarily paring the level of fat in the product insignificant amount of saturated fat;’’ per specified weight with that of the and reference product that it replaces is de- (iii) If the product meets these condi- clared adjacent to the most prominent tions without the benefit of special such claim or to the nutrition informa- processing, alteration, formulation, or tion (e.g., ‘‘fat content has been re- reformulation to lower saturated fat duced from 8 g per 3 oz to 5 g per 3 oz’’). content, it is labeled to clearly refer to (iii) Claims described in paragraph all products of its type and not merely (b)(5) of this section may not be made to the particular brand to which the on the label or in labeling of a product label attaches. if the nutrient content of the reference (2) The terms ‘‘low in saturated fat,’’ product meets the definition for ‘‘low ‘‘low saturated fat,’’ ‘‘contains a small fat.’’ amount of saturated fat,’’ ‘‘low source (6) The term ‘‘llllll percent fat of saturated fat,’’ or ‘‘a little saturated free’’ may be used on the label or in la- fat’’ may be used on the label or in labeling of products, provided that: beling of products, except meal-type (i) The product meets the criteria for products as defined in § 381.413(l) and ‘‘low fat’’ in paragraph (b)(2) or (b)(3) of main-dish products as defined in this section; § 381.413(m), provided that: (ii) The percent declared and the (i) The product contains 1 g or less of words ‘‘fat free’’ are in uniform type saturated fat per reference amount cus- size; and tomarily consumed and not more than (iii) A ‘‘100 percent fat free’’ claim 15 percent of calories from saturated may be made only on products that fat; and meet the criteria for ‘‘fat free’’ in para- (ii) If the product meets these condi- graph (b)(1) of this section, that con- tions without benefit of special proc- tain less than 0.5 g of fat per 100 g, and essing, alteration, formulation, or re- that contain no added fat. formulation to lower saturated fat con- (iv) A synonym for ‘‘lll percent tent, it is labeled to clearly refer to all fat free’’ is ‘‘lll percent lean.’’ products of its type and not merely to (c) Fatty acid content claims. (1) The the particular brand to which the label terms ‘‘saturated fat free,’’ ‘‘free of attaches.

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(3) The terms defined in paragraph label or in labeling of a meal-type (c)(2) of this section may be used on the product as defined in § 381.413(l) and label or in labeling of a meal-type main-dish product as defined in product as defined in § 381.413(l) and § 381.413(m), provided that: main-dish product as defined in (i) The product contains at least 25 § 381.413(m), provided that: percent less saturated fat per 100 g of (i) The product contains 1 g or less of product than an appropriate reference saturated fat per 100 g and less than 10 product as described in § 381.413(j)(1); percent calories from saturated fat; and and (ii) As required in § 381.413(j)(2) for (ii) If the product meets these condi- relative claims: tions without the benefit of special (A) The identity of the reference processing, alteration, formulation, or product and the percent (or fraction) reformulation to lower saturated fat that the saturated fat differs between content, it is labeled to clearly refer to the two products are declared in imme- all products of its type and not merely diate proximity to the most prominent to the particular brand to which the such claim (e.g., ‘‘reduced saturated fat label attaches. ‘product’, 50 percent less saturated fat (4) The terms ‘‘reduced saturated than our regular ‘product’ ’’); and fat,’’ ‘‘reduced in saturated fat,’’ (B) Quantitative information com- ‘‘saturated fat reduced,’’ ‘‘less satu- paring the level of saturated fat in the rated fat,’’ ‘‘lower saturated fat,’’ or product per specified weight with that ‘‘lower in saturated fat’’ may be used on the label or in labeling of products, of the reference product that it re- except meal-type products as defined in places is declared adjacent to the most § 381.413(l) and main-dish products as prominent claim or to the nutrition in- defined in § 381.413(m), provided that: formation (e.g., ‘‘saturated fat content (i) The product contains at least 25 has been reduced from 2.5 g per 3 oz to percent less saturated fat per reference 1.5 g per 3 oz’’). amount customarily consumed than an (iii) Claims described in paragraph appropriate reference product as de- (c)(5) of this section may not be made scribed in § 381.413(j)(1); and on the label or in labeling of a product (ii) As required in § 381.413(j)(2) for if the nutrient content of the reference relative claims: product meets the definition for ‘‘low (A) The identity of the reference saturated fat.’’ product and the percent (or fraction) (d) Cholesterol content claims. (1) The that the saturated fat differs between terms ‘‘cholesterol free,’’ ‘‘free of cho- the two products are declared in imme- lesterol,’’ ‘‘zero cholesterol,’’ ‘‘without diate proximity to the most prominent cholesterol,’’ ‘‘no cholesterol,’’ ‘‘trivial such claim (e.g., ‘‘reduced saturated fat source of cholesterol,’’ ‘‘negligible ‘product’, contains 50 percent less satu- source of cholesterol,’’ or ‘‘dietarily in- rated fat than the national average for significant source of cholesterol’’ may ‘product’ ’’); and be used on the label or in labeling of (B) Quantitative information com- products, provided that: paring the level of saturated fat in the (i) The product contains less than 2 product per labeled serving size with milligrams (mg) of cholesterol per ref- that of the reference product that it re- erence amount customarily consumed places is declared adjacent to the most and per labeled serving size or, in the prominent claim or to the nutrition in- case of a meal-type product as defined formation (e.g., ‘‘saturated fat reduced in § 381.413(l) and main-dish product as from 3 g to 1.5 g per serving’’). defined in § 381.413(m), less than 2 mg of (iii) Claims described in paragraph cholesterol per labeled serving size; (c)(4) of this section may not be made (ii) The product contains no ingre- on the label or in labeling of a product dient that is generally understood by if the nutrient content of the reference consumers to contain cholesterol, un- product meets the definition for ‘‘low less the listing of the ingredient in the saturated fat.’’ ingredients statement is followed by an (5) The terms defined in paragraph asterisk that refers to the statement (c)(4) of this section may be used on the below the list of ingredients, which

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states: ‘‘Adds a trivial amount of cho- (i)(A) If the product has a reference lesterol,’’ ‘‘adds a negligible amount of amount customarily consumed greater cholesterol,’’ or ‘‘adds a dietarily insig- than 30 g or greater than 2 tbsp: nificant amount of cholesterol’’; (1) The product contains 20 mg or less (iii) The product contains 2 g or less of cholesterol per reference amount of saturated fat per reference amount customarily consumed; and customarily consumed or, in the case (2) The product contains 2 g or less of of a meal-type product as defined in saturated fat per reference amount cus- § 381.413(l) and main-dish product as de- tomarily consumed; or fined in § 381.413(m), 2 g or less of satu- (B) If the product has a reference rated fat per labeled serving size; and amount customarily consumed of 30 g (iv) If the product meets these condi- or less or 2 tbsp or less: tions without the benefit of special (1) The product contains 20 mg or less processing, alteration, formulation, or of cholesterol per reference amount reformulation to lower cholesterol con- customarily consumed and per 50 g (for tent, it is labeled to clearly refer to all dehydrated products that must be re- products of its type and not merely to constituted before typical consumption the particular brand to which it at- with water or a diluent containing an taches; or insignificant amount, as defined in (v) If the product meets these condi- § 381.409(f)(1), of all nutrients per ref- tions only as a result of special proc- erence amount customarily consumed, essing, alteration, formulation, or re- the per-50-g criterion refers to the ‘‘as formulation, the amount of cholesterol prepared’’ form); and is reduced by 25 percent or more from (2) The product contains 2 g or less of the reference product it replaces as de- saturated fat per reference amount cus- scribed in § 381.413(j)(1) and for which it tomarily consumed. substitutes as described in § 381.413(d) (ii) If the product meets these condi- that has a significant (e.g., 5 percent or tions without the benefit of special more of a national or regional market) processing, alteration, formulation, or market share. As required in reformulation to lower cholesterol con- § 381.413(j)(2) for relative claims: tent, it is labeled to clearly refer to all products of its type and not merely to (A) The identity of the reference the particular brand to which the label product and the percent (or fraction) attaches; or that the cholesterol was reduced are (iii) If the product contains 20 mg or declared in immediate proximity to the less of cholesterol only as a result of most prominent such claim (e.g., ‘‘cho- special processing, alteration, formula- lesterol free ‘product’, contains 100 per- tion, or reformulation, the amount of cent less cholesterol than ‘reference cholesterol is reduced by 25 percent or product’ ’’); and more from the reference product it re- (B) Quantitative information com- places as described in § 381.413(j)(1) and paring the level of cholesterol in the for which it substitutes as described in product per labeled serving size with § 381.413(d) that has a significant (e.g., 5 that of the reference product that it re- percent or more of a national or replaces is declared adjacent to the most gional market) market share. As re- prominent claim or to the nutrition in- quired in § 381.413(j)(2) for relative formation (e.g., ‘‘contains no choles- claims: terol compared with 30 mg in one serv- (A) The identity of the reference ing of ‘reference product’ ’’). product and the percent (or fraction) (2) The terms ‘‘low in cholesterol,’’ that the cholesterol has been reduced ‘‘low cholesterol,’’ ‘‘contains a small are declared in immediate proximity to amount of cholesterol,’’ ‘‘low source of the most prominent such claim (e.g., cholesterol,’’ or ‘‘little cholesterol’’ ‘‘low cholesterol ‘product’, contains 85 may be used on the label or in labeling percent less cholesterol than our reg- of products, except meal-type products ular ‘product’’’); and as defined in § 381.413(l) and main-dish (B) Quantitative information com- products as defined in § 381.413(m), pro- paring the level of cholesterol in the vided that: product per labeled serving size with

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that of the reference product that it re- that of the reference product that it replaces is declared adjacent to the most places is declared adjacent to the most prominent claim or to the nutrition in- prominent claim or to the nutrition information (e.g., ‘‘cholesterol lowered formation (e.g., ‘‘cholesterol lowered from 30 mg to 5 mg per serving’’). from 55 mg to 30 mg per serving’’). (3) The terms defined in paragraph (iv) Claims described in paragraph (d)(2) of this section may be used on (d)(4) of this section may not be made the label or in labeling of a meal-type on the label or in labeling of a product product as defined in § 381.413(l) and if the nutrient content of the reference main-dish product as defined in product meets the definition for ‘‘low § 381.413(m), provided that: cholesterol.’’ (i) The product contains 20 mg or less (5) The terms defined in paragraph of cholesterol per 100 g of product; (d)(4) of this section may be used on (ii) The product contains 2 g or less the label or in labeling of a meal-type of saturated fat per 100 g of product; and product as defined in § 381.413(l) and (iii) If the product meets these condi- main-dish product as defined in tions without the benefit of special § 381.413(m), provided that: processing, alteration, formulation, or (i) The product has been specifically reformulation to lower cholesterol con- formulated, altered, or processed to re- tent, it is labeled to clearly refer to all duce its cholesterol by 25 percent or products of its type and not merely to more from the reference product it re- the particular brand to which the label places as described in § 381.413(j)(1) and attaches. for which it substitutes as described in (4) The terms ‘‘reduced cholesterol,’’ § 381.413(d) that has a significant (e.g., 5 ‘‘reduced in cholesterol,’’ ‘‘cholesterol percent or more of a national or re- reduced,’’ ‘‘less cholesterol,’’ ‘‘lower gional market) market share; cholesterol,’’ or ‘‘lower in cholesterol’’ (ii) The product contains 2 g or less may be used on the label or in labeling of saturated fat per 100 g of product; of products or products that substitute and for those products as specified in (iii) As required in § 381.413(j)(2) for § 381.413(d), excluding meal-type prod- relative claims: ucts as defined in § 381.413(l) and main- (A) The identity of the reference dish products as defined in § 381.413(m), product and the percent (or fraction) provided that: that the cholesterol has been reduced (i) The product has been specifically are declared in immediate proximity to formulated, altered, or processed to re- the most prominent such claim (e.g., duce its cholesterol by 25 percent or ‘‘25% less cholesterol than ‘reference more from the reference product it re- product’ ’’); and places as described in § 381.413(j)(1) and (B) Quantitative information com- for which it substitutes as described in paring the level of cholesterol in the § 381.413(d) that has a significant (e.g., 5 product per specified weight with that percent or more of a national or re- of the reference product that it regional market) market share; (ii) The product contains 2 g or less places is declared adjacent to the most of saturated fat per reference amount prominent claim or to the nutrition in- customarily consumed; and formation (e.g., ‘‘cholesterol content (iii) As required in § 381.413(j)(2) for has been reduced from 35 mg per 3 oz to relative claims: 25 mg per 3 oz). (A) The identity of the reference (iv) Claims described in paragraph product and the percent (or fraction) (d)(5) of this section may not be made that the cholesterol has been reduced on the label or in labeling of a product are declared in immediate proximity to if the nutrient content of the reference the most prominent such claim (e.g., product meets the definition for ‘‘low ‘‘25 percent less cholesterol than ‘ref- cholesterol.’’ erence product’ ’’); and (e) ‘‘Lean’’ and ‘‘Extra Lean’’ claims. (B) Quantitative information com- (1) The term ‘‘lean’’ may be used on the paring the level of cholesterol in the label or in labeling of a product, pro- product per labeled serving size with vided that the product contains less

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than 10 g of fat, 4.5 g or less of satu- saturated fat criteria for ‘‘extra lean’’ rated fat, and less than 95 mg of choles- in § 381.462. terol per 100 g of product and per ref- (2) The product shall not contain erence amount customarily consumed more than 60 milligrams (mg) of cho- for individual foods, and per 100 g of lesterol per reference amount custom- product and per labeled serving size for arily consumed, per labeled serving meal-type products as defined in size, and, only for foods with reference § 381.413(l) and main-dish products as amounts customarily consumed of 30 defined in § 381.413(m). grams (g) or less or 2 tablespoons (tbsp) (2) The term ‘‘extra lean’’ may be or less, per 50 g, and, for dehydrated used on the label or in labeling of a products that must be reconstituted product, provided that the product con- with water or a diluent containing an tains less than 5 g of fat, less than 2 g insignificant amount, as defined in of saturated fat, and less than 95 mg of § 381.409(f)(1), of all nutrients, the per- cholesterol per 100 g of product and per 50-g criterion refers to the prepared reference amount customarily conform, except that: sumed for individual foods, and per 100 (i) A main-dish product, as defined in g of product and per labeled serving § 381.413(m), and meal-type product, as size for meal-type products as defined defined in § 381.413(l), and including in § 381.413(l) and main-dish products as meal-type products that weigh more defined in § 381.413(m). than 12 ounces (oz) per serving (container), shall not contain more than 90 [60 FR 214, Jan. 3, 1995, as amended at 69 FR mg of cholesterol per labeled serving 58803, Oct. 1, 2004] size; and EFFECTIVE DATE NOTE: At 75 FR 82167, Dec. (ii) Single-ingredient, raw products 29, 2010, § 381.462 was amended by adding a may meet the cholesterol criterion for new paragraph (f), effective Jan. 1, 2012. At 76 ‘‘extra lean’’ in § 381.462. FR 76890, Dec. 9, 2011, the effectiveness was (3) The product shall not contain delayed until Mar. 1, 2012. For the conven- more than 480 mg of sodium per ref- ience of the user, the added text is set forth erence amount customarily consumed, as follows: per labeled serving size, and, only for § 381.462 Nutrient content claims for fat, foods with reference amounts custom- fatty acids, and cholesterol content. arily consumed of 30 g or less or 2 tbsp or less, per 50 g, and, for dehydrated * * * * * products that must be reconstituted with water or a diluent containing an (f) A statement of the lean percentage may insignificant amount, as defined in be used on the label or in labeling of ground § 381.409(f)(1), of all nutrients, the per- or chopped poultry products described in § 381.401 when the product does not meet the 50-g criterion refers to the prepared criteria for ‘‘low fat,’’ defined in form, except that: § 381.462(b)(2), provided that a statement of (i) A main-dish product, as defined in the fat percentage is contiguous to and in § 381.413(m), and meal-type product, as lettering of the same color, size, type, and on defined in § 381.413(l), and including the same color background, as the statement meal-type products that weigh more of the lean percentage. than 12 oz per serving (container), shall not contain more than 600 mg of so- § 381.463 Nutrient content claims for 1 ‘‘healthy.’’ dium per labeled serving size; and

(a) The term ‘‘healthy,’’ or any other 1 This regulation previously provided that, derivative of the term ‘‘health,’’ may after January 1, 2006, individual poultry be used on the labeling of any poultry products bearing the claim ‘‘healthy’’ (or product, provided that the product is any derivative of the term ‘‘health’’) must labeled in accordance with § 381.409 and contain no more than 360 mg of sodium and § 381.413. that meal-type products bearing the claim (b)(1) The product shall meet the re- ‘‘healthy’’ (or any other derivative of the term ‘‘health’’) must contain no more than quirements for ‘‘low fat’’ and ‘‘low 600 mg of sodium. Implementation of these saturated fat,’’ as defined in § 381.462, sodium level requirements for products bear- except that single-ingredient, raw ing the claim ‘‘healthy’’ (or any derivative of products may meet the total fat and Continued

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(ii) The requirements of this para- panied by an accurate and complete graph (b)(3) do not apply to single-in- English translation. The labeling appli- gredient, raw products. cation shall state the applicant’s post (4) The product shall contain 10 per- office address. cent or more of the Reference Daily In- (d) Pertinent information will be take or Daily Reference Value as de- considered as part of an application on fined in § 381.409 for vitamin A, vitamin the basis of specific reference to such C, iron, calcium, protein, or fiber per information submitted to and retained reference amount customarily con- in the files of the Food Safety and In- sumed prior to any nutrient addition, spection Service. However, any ref- except that: erence to unpublished information fur- (i) A main-dish product, as defined in nished by a person other than the ap- § 381.413(m), and including meal-type plicant will not be considered unless products that weigh less than 10 oz per use of such information is authorized serving (container), shall meet the (with the understanding that such in- level for two of the nutrients per la- formation may in whole or part be sub- beled serving size; and ject to release to the public) in a writ- (ii) A meal-type product, as defined ten statement signed by the person in § 381.413(l), shall meet the level for who submitted it. Any reference to three of the nutrients per labeled serv- published information should be ac- ing size. companied by reprints or photostatic [59 FR 24228, May 10, 1994, as amended at 60 copies of such references. FR 217, Jan. 3, 1995; 63 FR 7281, Feb. 13, 1998; (e) If nonclinical laboratory studies 64 FR 72492, Dec. 28, 1999; 68 FR 463, Jan. 6, accompany a labeling application, the 2003; 69 FR 58803, Oct. 1, 2004; 71 FR 1686, Jan. applicant shall include, with respect to 11, 2006] each nonclinical study included with the application, either a statement §§ 381.464–381.468 [Reserved] that the study has been, or will be, § 381.469 Labeling applications for nu- conducted in compliance with the good trient content claims. laboratory practice regulations as set (a) This section pertains to labeling forth in part 58 of chapter 1, title 21, or, applications for claims, express or im- if any such study was not conducted in plied, that characterize the level of any compliance with such regulations, a nutrient required to be on the label or brief statement of the reason for the in labeling of product by this subpart. noncompliance. (b) Labeling applications included in (f) If clinical investigations accom- this section are: pany a labeling application, the appli- (1) Labeling applications for a new cant shall include, with respect to each (heretofore unauthorized) nutrient con- clinical investigation included with the tent claim, application, either a statement that (2) Labeling applications for a syn- the investigation was conducted in onymous term (i.e., one that is con- compliance with the requirements for sistent with a term defined by regula- institutional review set forth in part 56 tion) for characterizing the level of a of chapter 1, title 21, or was not subject nutrient, and to such requirements in accordance (3) Labeling applications for the use with § 56.194 or § 56.105, and that it was of an implied claim in a brand name. conducted in compliance with the re- (c) Labeling applications and sup- quirements for informed consents set porting documentation to be filed forth in part 50 of chapter 1, title 21. under this section shall be submitted (g) The availability for public disclo- in quadruplicate, except that the sup- sure of labeling applications, along porting documentation may be sub- with supporting documentation, submitted on a computer disc copy. If any mitted to the Agency under this sec- part of the material submitted is in a tion will be governed by the rules spec- foreign language, it shall be accom- ified in subchapter D, title 9. (h) The data specified under this sec- the term ‘‘health’’) has been deferred indefi- tion to accompany a labeling applica- nitely due to technological barriers and con- tion shall be submitted on separate sumer preferences. sheets, suitably identified. If such data

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has already been submitted with an tended for a specific group within the popu- earlier labeling application from the lation, the analysis shall specifically address applicant, the present labeling applica- nutritional needs of such group, and sci- tion must provide the data. entific data sufficient for such purpose, and data and information to the extent necessary (i) The labeling application must be to demonstrate that consumers can be ex- signed by the applicant or by his or her pected to understand the meaning of the attorney or agent, or (if a corporation) term under the proposed conditions of use. by an authorized official. (iii) Analytical data that demonstrates the (j) The labeling application shall in- amount of the nutrient that is present in the clude a statement signed by the person products for which the claim is intended. responsible for the labeling applica- The assays should be performed on rep- tion, that to the best of his or her resentative samples in accordance with knowledge, it is a representative and 381.409(h). If no USDA or AOAC methods are available, the applicant shall submit the balanced submission that includes un- assay method used, and data establishing the favorable information, as well as favor- validity of the method for assaying the nu- able information, known to him or her trient in the particular food. The validation pertinent to the evaluation of the la- data shall include a statistical analysis of beling application. the analytical and product variability. (k)(1) Labeling applications for a new (iv) A detailed analysis of the potential ef- nutrient content claim shall be accom- fect of the use of the proposed claim on food panied by the following data which consumption, and any corresponding changes shall be submitted in the following in nutrient intake. The analysis shall specifically address the intake of nutrients that form to the Director, Food Labeling have beneficial and negative consequences in Division, Regulatory Programs, Food the total diet. If the claim is intended for a Safety and Inspection Service, Wash- specific group within the population, the ington, DC 20250: above analysis shall specifically address the dietary practices of such group, and shall in- llllllllllllllllllllllll clude data sufficient to demonstrate that the (Date) dietary analysis is representative of such The undersigned, llllll submits this group. labeling application pursuant to 9 CFR 381.469 with respect to (statement of the Yours very truly, claim and its proposed use). Applicant lllllllllllllll Attached hereto, in quadruplicate, or on a By lllllllllllllllllll computer disc copy, and constituting a part (Indicate authority) of this labeling application, are the following: (2) Upon receipt of the labeling appli- (i) A statement identifying the nutrient cation and supporting documentation, content claim and the nutrient that the the applicant shall be notified, in writ- term is intended to characterize with respect ing, of the date on which the labeling to the level of such nutrient. The statement application was received. Such notice shall address why the use of the term as pro- shall inform the applicant that the la- posed will not be misleading. The statement shall provide examples of the nutrient con- beling application is undergoing Agen- tent claim as it will be used on labels or la- cy review and that the applicant shall beling, as well as the types of products on subsequently be notified of the Agen- which the claim will be used. The statement cy’s decision to consider for further re- shall also specify the level at which the nu- view or deny the labeling application. trient must be present or what other condi- (3) Upon review of the labeling appli- tions concerning the product must be met cation and supporting documentation, for the appropriate use of the term in labels or labeling, as well as any factors that would the Agency shall notify the applicant, make the use of the term inappropriate. in writing, that the labeling applica- (ii) A detailed explanation supported by tion is either being considered for fur- any necessary data of why use of the food ther review or that it has been sum- component characterized by the claim is of marily denied by the Administrator. importance in human nutrition by virtue of (4) If the labeling application is sum- its presence or absence at the levels that marily denied by the Administrator, such claim would describe. This explanation the written notification shall state the shall also state what nutritional benefit to the public will derive from use of the claim reasons therefor, including why the as proposed and why such benefit is not Agency has determined that the pro- available through the use of existing terms posed nutrient content claim is false or defined by regulation. If the claim is in- misleading. The notification letter

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shall inform the applicant that the ap- approved for use on the labeling of plicant may submit a written state- poultry products. ment by way of answer to the notifica- (i) If the claim is denied by the Ad- tion, and that the applicant shall have ministrator, the Agency shall notify the right to request a hearing with re- the applicant, in writing, of the basis spect to the merits or validity of the for the denial, including the reason Administrator’s decision to deny the why the claim on the labeling was de- use of the proposed nutrient content termined by the Agency to be false or claim. misleading. The notification letter (i) If the applicant fails to accept the shall also inform the applicant that the determination of the Administrator applicant may submit a written state- and files an answer and requests a ment by way of answer to the notifica- hearing, and the Administrator, after tion, and that the applicant shall have review of the answer, determines the the right to request a hearing with re- initial determination to be correct, the spect to the merits or validity of the Administrator shall file with the Hear- Administrator’s decision to deny the ing Clerk of the Department the notifi- use of the proposed nutrient content cation, answer, and the request for a claim. hearing, which shall constitute the (A) If the applicant fails to accept complaint and answer in the pro- the determination of the Adminis- ceeding, which shall thereafter be con- trator and files an answer and requests ducted in accordance with the Depart- ment’s Uniform Rules of Practice. a hearing, and the Administrator, after review of the answer, determines the (ii) The hearing shall be conducted initial determination to be correct, the before an administrative law judge with the opportunity for appeal to the Administrator shall file with the Hear- Department’s Judicial Officer, who ing Clerk of the Department the notifi- shall make the final determination for cation, answer, and the request for a the Secretary. Any such determination hearing, which shall constitute the by the Secretary shall be conclusive complaint and answer in the pro- unless, within 30 days after receipt of ceeding, which shall thereafter be con- notice of such final determination, the ducted in accordance with the Depart- applicant appeals to the United States ment’s Uniform Rules of Practice. Court of Appeals for the circuit in (B) The hearing shall be conducted which the applicant has its principal before an administrative law judge place of business or to the United with the opportunity for appeal to the States Court of Appeals for the District Department’s Judicial Officer, who of Columbia Circuit. shall make the final determination for (5) If the labeling application is not the Secretary. Any such determination summarily denied by the Adminis- by the Secretary shall be conclusive trator, the Administrator shall publish unless, within 30 days after receipt of in the FEDERAL REGISTER a proposed the notice of such final determination, rule to amend the regulations to au- the applicant appeals to the United thorize the use of the nutrient content States Court of Appeals for the circuit claim. The proposal shall also summa- in which the applicant has its principal rize the labeling application, including place of business or to the United where the supporting documentation States Court of Appeals for the District can be reviewed. The Administrator’s of Columbia Circuit. proposed rule shall seek comment from (ii) If the claim is approved, the consumers, the industry, consumer and Agency shall notify the applicant, in industry groups, and other interested writing, and shall also publish in the persons on the labeling application and FEDERAL REGISTER a final rule amend- the use of the proposed nutrient con- ing the regulations to authorize the tent claim. After public comment has use of the claim. been received and reviewed by the Agency, the Administrator shall make (l)(1) Labeling applications for a syn- a determination on whether the pro- onymous term shall be accompanied by posed nutrient content claim shall be

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the following data which shall be sub- beling application is undergoing Agen- mitted in the following form to the Di- cy review and that the applicant shall rector, Food Labeling Division, Regu- subsequently be notified of the Agen- latory Programs, Food Safety and In- cy’s decision to consider for further re- spection Service, Washington, DC 20250: view or deny the labeling application. (3) Upon review of the labeling appli- llllllllllllllllllllllll (Date) cation and supporting documentation, the Agency shall notify the applicant, The undersigned, llllll submits this labeling application pursuant to 9 CFR in writing, that the labeling applica- 381.469 with respect to (statement of the syn- tion is either being considered for fur- onymous term and its proposed use in a nu- ther review or that it has been sum- trient content claim that is consistent with marily denied by the Administrator. an existing term that has been defined under (4) If the labeling application is sum- subpart Y of part 381). marily denied by the Administrator, Attached hereto, in quadruplicate, or on a the written notification shall state the computer disc copy, and constituting a part of this labeling application, are the fol- reasons therefor, including why the lowing: Agency has determined that the pro- (i) A statement identifying the synony- posed synonymous term is false or mis- mous term, the existing term defined by a leading. The notification letter shall regulation with which the synonymous term inform the applicant that the applicant is claimed to be consistent, and the nutrient may submit a written statement by that the term is intended to characterize the way of answer to the notification, and level of. The statement shall address why the that the applicant shall have the right use of the synonymous term as proposed will not be misleading. The statement shall pro- to request a hearing with respect to vide examples of the nutrient content claim the merits or validity of the Adminis- as it will be used on labels or labeling, as trator’s decision to deny the use of the well as the types of products on which the proposed synonymous term. claim will be used. The statement shall also (i) If the applicant fails to accept the specify whether any limitations not applica- determination of the Administrator ble to the use of the defined term are in- and files an answer and requests a tended to apply to the use of the synony- hearing, and the Administrator, after mous term. (ii) A detailed explanation supported by review of the answer, determines the any necessary data of why use of the pro- initial determination to be correct, the posed term is requested, including whether Administrator shall file with the Hear- the existing defined term is inadequate for ing Clerk of the Department the notifi- the purpose of effectively characterizing the cation, answer, and the request for a level of a nutrient. This explanation shall hearing, which shall constitute the also state what nutritional benefit to the complaint and answer in the pro- public will derive from use of the claim as ceeding, which shall thereafter be con- proposed, and why such benefit is not available through use of existing terms defined by ducted in accordance with the Depart- regulation. If the claim is intended for a spe- ment’s Uniform Rules of Practice. cific group within the population, the anal- (ii) The hearing shall be conducted ysis shall specifically address nutritional before an administrative law judge needs of such group, scientific data sufficient with the opportunity for appeal to the for such purpose, and data and information Department’s Judicial Officer, who to the extent necessary to demonstrate that shall make the final determination for consumers can be expected to understand the the Secretary. Any such determination meaning of the term under the proposed conditions of use. by the Secretary shall be conclusive unless, within 30 days after receipt of Yours very truly, notice of such final determination, the Applicant lllllllllllllll applicant appeals to the United States By lllllllllllllllllll Court of Appeals for the circuit in (Indicate authority) which the applicant has its principal (2) Upon receipt of the labeling appli- place of business or to the United cation and supporting documentation, States Court of Appeals for the District the applicant shall be notified, in writ- of Columbia Circuit. ing, of the date on which the labeling (5) If the claim is approved, the Agen- application was received. Such notice cy shall notify the applicant, in writ- shall inform the applicant that the la- ing, and shall publish in the FEDERAL

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REGISTER a notice informing the public shall inform the applicant that the la- that the synonymous term has been ap- beling application is undergoing Agen- proved for use. cy review and that the applicant shall (m)(1) Labeling applications for the subsequently be notified of the Agen- use of an implied nutrient content cy’s decision to consider for further re- claim in a brand name shall be accom- view or deny the labeling application. panied by the following data which (3) Upon review of the labeling appli- shall be submitted in the following cation and supporting documentation, form to the Director, Food Labeling the Agency shall notify the applicant, Division, Regulatory Programs, Food in writing, that the labeling applica- Safety and Inspection Service, Wash- tion is either being considered for fur- ington, DC 20250: ther review or that it has been sum- llllllllllllllllllllllll marily denied by the Administrator. (Date) (4) If the labeling application is sum- The undersigned, llllll submits this marily denied by the Administrator, labeling application pursuant to 9 CFR the written notification shall state the 381.469 with respect to (statement of the im- reasons therefor, including why the plied nutrient content claim and its proposed Agency has determined that the pro- use in a brand name). posed implied nutrient content claim is Attached hereto, in quadruplicate, or on a false or misleading. The notification computer disc copy, and constituting a part of this labeling application, are the fol- letter shall inform the applicant that lowing: the applicant may submit a written (i) A statement identifying the implied nu- statement by way of answer to the no- trient content claim, the nutrient the claim tification, and that the applicant shall is intended to characterize, the cor- have the right to request a hearing responding term for characterizing the level with respect to the merits or validity of such nutrient as defined by a regulation, of the Administrator’s decision to deny and the brand name of which the implied claim is intended to be a part. The statement the use of the proposed implied nutri- shall address why the use of the brand-name ent content claim. as proposed will not be misleading. The (i) If the applicant fails to accept the statement shall provide examples of the determination of the Administrator types of products on which the brand name and files an answer and requests a will appear. It shall also include data show- hearing, and the Administrator, after ing that the actual level of the nutrient in review of the answer, determines the the food would qualify the label of the product to bear the corresponding term defined initial determination to be correct, the by regulation. Assay methods used to deter- Administrator shall file with the Hear- mine the level of a nutrient shall meet the ing Clerk of the Department the notifi- requirements stated under labeling applica- cation, answer, and the request for a tion format in paragraph (k)(1)(iii) of this hearing, which shall constitute the section. complaint and answer in the pro- (ii) A detailed explanation supported by ceeding, which shall thereafter be con- any necessary data of why use of the proposed brand name is requested. This expla- ducted in accordance with the Depart- nation shall also state what nutritional ben- ment’s Uniform Rules of Practice. efit to the public will derive from use of the (ii) The hearing shall be conducted brand name as proposed. If the branded prod- before an administrative law judge uct is intended for a specific group within with the opportunity for appeal to the the population, the analysis shall specifi- Department’s Judicial Officer, who cally address nutritional needs of such group shall make the final determination for and scientific data sufficient for such purpose. the Secretary. Any such determination Yours very truly, by the Secretary shall be conclusive unless, within 30 days after receipt of Applicant lllllllllllllll notice of such final determination, the By lllllllllllllllllll applicant appeals to the United States (2) Upon receipt of the labeling appli- Court of Appeals for the circuit in cation and supporting documentation, which the applicant has its principal the applicant shall be notified, in writ- place of business or to the United ing, of the date on which the labeling States Court of Appeals for the District application was received. Such notice of Columbia Circuit.

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(5) If the labeling application is not unless, within 30 days after receipt of summarily denied by the Adminis- the notice of such final determination, trator, the Administrator shall publish the applicant appeals to the United a notice of the labeling application in States Court of Appeals for the circuit the FEDERAL REGISTER seeking a com- in which the applicant has its principal ment on the use of the implied nutrient place of business or to the United content claim. The notice shall also States Court of Appeals for the District summarize the labeling application, in- of Columbia Circuit. cluding where the supporting docu- (ii) If the claim is approved, the mentation can be reviewed. The Ad- Agency shall notify the applicant, in ministrator’s notice shall seek com- writing, and shall also publish in the ment from consumers, the industry, FEDERAL REGISTER a notice informing consumer and industry groups, and the public that the implied nutrient other interested persons on the label- content claim has been approved for ing application and the use of the im- use. plied nutrient content claim. After (Paperwork requirements were approved by public comment has been received and the Office of Management and Budget under reviewed by the Agency, the Adminis- control number 0583–0088.) trator shall make a determination on whether the implied nutrient content [58 FR 675, Jan. 6, 1993, as amended at 59 FR 45198, Sept. 1, 1994; 60 FR 217, Jan. 3, 1995] claim shall be approved for use on the labeling of poultry products. §§ 381.470–381.479 [Reserved] (i) If the claim is denied by the Ad- ministrator, the Agency shall notify § 381.480 Label statements relating to the applicant, in writing, of the basis usefulness in reducing or maintain- for the denial, including the reason ing body weight. why the claim on the labeling was de- (a) General requirements. Any product termined by the Agency to be false or that purports to be or is represented misleading. The notification letter for special dietary use because of use- shall also inform the applicant that the fulness in reducing body weight shall applicant may submit a written state- bear: ment by way of answer to the notifica- (1) Nutrition labeling in conformity tion, and that the applicant shall have with § 381.409 of this subpart, unless ex- the right to request a hearing with re- empt under that section, and spect to the merits or validity of the (2) A conspicuous statement of the Administrator’s decision to deny the basis upon which the product claims to use of the proposed implied nutrient be of special dietary usefulness. content claim. (b) Nonnutritive ingredients. (1) Any (A) If the applicant fails to accept product subject to paragraph (a) of this the determination of the Adminis- section that achieves its special die- trator and files an answer and requests tary usefulness by use of a nonnutri- a hearing, and the Administrator, after tive ingredient (i.e., one not utilized in review of the answer, determines the normal metabolism) shall bear on its initial determination to be correct, the label a statement that it contains a Administrator shall file with the Hear- nonnutritive ingredient and the per- ing Clerk of the Department the notifi- centage by weight of the nonnutritive cation, answer, and the request for a ingredient. hearing, which shall constitute the (2) A special dietary product may complaint and answer in the pro- contain a nonnutritive sweetener or ceeding, which shall thereafter be con- other ingredient only if the ingredient ducted in accordance with the Depart- is safe for use in the product under the ment’s Uniform Rules of Practice. applicable law and regulations of this (B) The hearing shall be conducted chapter. Any product that achieves its before an administrative law judge special dietary usefulness in reducing with the opportunity for appeal to the or maintaining body weight through Department’s Judicial Officer, who the use of a nonnutritive sweetener shall make the final determination for shall bear on its label the statement the Secretary. Any such determination required by paragraph (b)(1) of this sec- by the Secretary shall be conclusive tion, but need not state the percentage

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by weight of the nonnutritive sweet- §§ 381.481–381.499 [Reserved] ener. If a nutritive sweetener(s) as well as nonnutritive sweetener(s) is added, § 381.500 Exemption from nutrition la- the statement shall indicate the pres- beling. ence of both types of sweetener; e.g., (a) The following poultry products ‘‘Sweetened with nutritive sweetener(s) are exempt from nutrition labeling: and nonnutritive sweetener(s).’’ (1) Food products produced by small (c)‘‘Low calorie’’ foods. A product pur- businesses, provided that the labels for porting to be ‘‘low calorie’’ must com- these products bear no nutrition claims ply with the criteria set forth for such or nutrition information, foods in § 381.460. (i) A food product, for purposes of the small business exemption, is defined as (d) ‘‘Reduced calorie’’ foods and other a formulation, not including distinct A product pur- comparative claims. flavors which do not significantly alter porting to be ‘‘reduced calorie’’ or oth- the nutritional profile, sold in any size erwise containing fewer calories than a package in commerce. reference food must comply with the (ii) For purposes of this paragraph, a criteria set forth for such foods in small business is any single-plant facil- § 387.460(b) (4) and (5). ity or multi-plant company/firm that (e) ‘‘Label terms suggesting usefulness employs 500 or fewer people and pro- as low calorie or reduced calorie foods’’. duces no more than the following (1) Except as provided in paragraphs amounts of pounds of the product (e)(2) and (e)(3) of this section, a prod- qualifying the firm for exemption from uct may be labeled with terms such as this subpart: ‘‘diet,’’ ‘‘dietetic,’’ ‘‘artificially sweet- (A) During the first year of imple- ened,’’ or ‘‘sweetened with nonnutri- mentation of nutrition labeling, from tive sweetener’’ only if the claim is not July 1994 to July 1995, 250,000 pounds or false or misleading, and the product is less, labeled ‘‘low calorie’’ or ‘‘reduced cal- (B) During the second year of imple- orie’’ or bears another comparative cal- mentation of nutrition labeling, from orie claim in compliance with the ap- July 1995 to July 1996, 175,000 pounds or plicable provisions in this subpart. less, and (C) During the third year of imple- (2) Paragraph (e)(1) of this section mentation and subsequent years there- shall not apply to any use of such after, 100,000 pounds or less. terms that is specifically authorized by (iii) For purposes of this paragraph, regulation governing a particular food, calculation of the amount of pounds or, unless otherwise restricted by regu- shall be based on the most recent 2- lation, to any use of the term ‘‘diet’’ year average of business activity. that clearly shows that the product is Where firms have been in business less offered solely for a dietary use other than 2 years or where products have than regulating body weight, e.g., ‘‘for been produced for less than 2 years, low sodium diets.’’ reasonable estimates must indicate (3) Paragraph (e)(1) of this section that the annual pounds produced will shall not apply to any use of such not exceed the amounts specified. terms on a formulated meal replace- (2) Products intended for further ment or other product that is rep- processing, provided that the labels for resented to be of special dietary use as these products bear no nutrition claims a whole meal, pending the issuance of a or nutrition information, regulation governing the use of such (3) Products that are not for sale to terms on foods. consumers, provided that the labels for (f) ‘‘Sugar free’’ and ‘‘no added these products bear no nutrition claims or nutrition information, sugar’’. Criteria for the use of the (4) Products in small packages that terms ‘‘sugar free’’ and ‘‘no added are individually wrapped packages of sugar’’ are provided for in § 381.460(c). less than 1⁄2 ounce net weight, provided [58 FR 675, Jan. 6, 1993; 58 FR 43789, Aug. 18, that the labels for these products bear 1993, as amended at 58 FR 47628, Sept. 10, no nutrition claims or nutrition infor- 1993; 60 FR 217, Jan. 3, 1995] mation,

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(5) Products custom slaughtered or qualify for and use this exemption, an prepared, address or telephone number that a (6) Products intended for export, and consumer can use to obtain the re- (7) The following products prepared quired nutrition information (e.g., and served or sold at retail provided ‘‘For nutrition information call 1–800– that the labels or the labeling of these 123–4567’’). products bear no nutrition claims or (2) When such products bear nutri- nutrition information: tion labeling, either voluntarily or be- (i) Ready-to-eat products that are cause nutrition claims or other nutri- packaged or portioned at a retail store tion information is provided, all re- or similar retail-type establishment; quired information shall be in a type and size no smaller than 6 point or all (ii) Multi-ingredient products (e.g. upper case type of 1⁄16-inch minimum sausage) processed at a retail store or height, except that individual serving- similar retail-type establishment. size packages of poultry products that (b) Restaurant menus generally do have a total area available to bear la- not constitute labeling or fall within beling of 3 square inches or less may the scope of these regulations. provide all required information in a (c)(1) Foods represented to be specifi- type size no smaller than 1⁄32-inch min- cally for infants and children less than imum height. 2 years of age shall bear nutrition labeling as provided in paragraph (c)(2) of [58 FR 675, Jan. 6, 1993, as amended at 58 FR 47628, Sept. 10, 1993; 59 FR 45198, Sept. 1, 1994; this section, except such labeling shall 60 FR 217, Jan. 3, 1995] not include calories from fat, calories from saturated fat, saturated fat, ste- EFFECTIVE DATE NOTE: 1. At 75 FR 82167, aric acid, polyunsaturated fat, Dec. 29, 2010, § 381.500 was amended as follows, monounsaturated fat, and cholesterol. effective Jan. 1, 2012. At 76 FR 76890, Dec. 9, 2011, the effectiveness was delayed until Mar. (2) Foods represented or purported to 1, 2012. be specifically for infants and children a. Revising paragraph (a)(1) introductory less than 4 years of age shall bear nu- text; trition labeling except that: b. Amending paragraph (a)(1)(ii) by adding, (i) Such labeling shall not include ‘‘, including a single retail store,’’ after the declarations of percent of Daily Value phrase ‘‘single-plant facility,’’ and by adding for total fat, saturated fat, cholesterol, ‘‘,including a multi-retail store operation’’ sodium, potassium, total carbohydrate, after ‘‘company/firm’’; and dietary fiber; c. Amending paragraph (a)(7)(i) by removing the semi-colon and ‘‘and’’ and adding the (ii) Nutrient names and quantitative following at the end of the paragraph: ‘‘, pro- amounts by weight shall be presented vided, however, that this exemption does not in two separate columns; apply to ready-to-eat ground or chopped (iii) The heading ‘‘Percent Daily poultry products described in § 381.401 that Value’’ required in § 381.409(d)(6) shall are packaged or portioned at a retail estab- be placed immediately below the quan- lishment, unless the establishment qualifies titative information by weight for pro- for an exemption under (a)(1);’’; tein; d. Amending paragraph (a)(7)(ii) by remov- (iv) The percent of the Daily Value ing the period and adding the following at the end of the paragraph: ‘‘, provided, how- for protein, vitamins, and minerals ever, that this exemption does not apply to shall be listed immediately below the multi-ingredient ground or chopped poultry heading ‘‘Percent Daily Value’’; and products described in § 381.401 that are proc- (v) Such labeling shall not include essed at a retail establishment, unless the the footnote specified in § 381.409(d)(9). establishment qualifies for an exemption (d)(1) Products in packages that have under (a)(1); and’’; a total surface area available to bear e. Adding a new paragraph (a)(7)(iii); and labeling of less than 12 square inches f. Amending paragraph (d)(1) by removing are exempt from nutrition labeling, the period at the end of the sentence, and by adding the following to the end of the sen- provided that the labeling for these tence: ‘‘except that this exemption does not products bear no nutrition claims or apply to the major cuts of single-ingredient, other nutrition information. The man- raw poultry products identified in § 381.444.’’ ufacturer, packer, or distributor shall For the convenience of the user, the added provide, on the label of packages that and revised text is set forth as follows:

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§ 381.500 Exemption from nutrition labeling. Designated personnel. State inspection (a) * * * personnel that have been trained in the (1) Food products produced by small busi- enforcement of the Act and any addi- nesses other than the major cuts of single-in- tional State program requirements in gredient, raw poultry products identified in order to provide inspection services to § 381.444 produced by small businesses, pro- selected establishments. vided that the labels for these products bear Interstate commerce. ‘‘Interstate com- no nutrition claims or nutrition information, and ground or chopped products de- merce’’ has the same meaning as scribed in § 381.401 produced by small busi- ‘‘commerce’’ under § 381.1 of this part. nesses that bear a statement of the lean per- Selected establishment. An establish- centage and fat percentage on the label or in ment operating under a State coopera- labeling in accordance with § 381.462(f), pro- tive poultry products inspection provided that labels or labeling for these prod- gram that has been selected by the Ad- ucts bear no other nutrition claims or nutri- ministrator, in coordination with the tion information, State where the establishment is located, to participate in a cooperative * * * * * interstate shipment program. (7) * * * § 381.512 Purpose. (iii) Products that are ground or chopped at an individual customer’s request. This subpart Z prescribes the conditions under which States that admin- * * * * * ister cooperative State poultry products inspection programs and estab- 2. At 76 FR 76891, Dec. 9, 2011, the Dec. 29, lishments that operate under such pro- 2010 document was corrected on page 82167, grams may participate in a cooperative in the third column, in Part 381 Poultry Products Inspection Regulations, in amend- interstate shipment program. ment 17f, the instruction ‘‘Amending paragraph (d)(1) by removing the period at the § 381.513 Requirements for establish- end of the sentence, and by adding the fol- ments; ineligible establishments. lowing to the end of the sentence: ‘except (a) An establishment that operates that this exemption does not apply to the under a cooperative State poultry major cuts of single-ingredient, raw poultry products inspection program may products identified in § 381.444.’ ’’ is corrected apply to participate in a cooperative to read ‘‘Amending paragraph (d)(1) by re- interstate shipment program under moving the period at the end of the first sentence, and by adding the following to the end this subpart if: of the first sentence: ‘, except that this ex- (1) The establishment employs on av- emption does not apply to the major cuts of erage no more than 25 employees based single-ingredient, raw poultry products iden- on the standards described in para- tified in § 381.444.’ ’’, effective Mar. 1, 2012. graph (b) of this section, or (2) The establishment employed more Subpart Z—Selected Establish- than 25 employees but fewer than 35 ments; Cooperative Program employees as of June 18, 2008. If se- for Interstate Shipment of lected to participate in a cooperative interstate shipment program, an estab- Poultry Products lishment under this paragraph must employ on average no more than 25 em- SOURCE: 76 FR 24756, May 2, 2011, unless ployees as of July 1, 2014, or it must otherwise noted. transition to become an official establishment as provided in § 381.521 of this § 381.511 Definitions. subpart. Cooperative interstate shipment pro- (b) An establishment that has 25 or gram. A cooperative poultry products fewer employees based on the following inspection program described in standards is considered to have 25 or § 381.187 of this part. fewer employees on average for pur- Cooperative State poultry products in- poses of this subpart. spection program. A cooperative State- (1) All individuals, both supervisory Federal poultry products inspection and non-supervisory, employed by the program described in § 381.185 of this establishment on a full-time, part- part. time, or temporary basis whose duties

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involve handling the poultry products (7) Establishments that are in viola- prepared by the establishment are tion of the Act; counted when calculating the total (8) Establishments located in States number of employees. without a cooperative State poultry (2) All individuals employed by the products inspection program; and establishment from a temporary em- (9) Establishments located in a State ployee agency, professional employee whose agreement for a cooperative organization, or leasing concern whose interstate shipment program was ter- duties involve handling the poultry minated by the Administrator as pro- products prepared by the establishment vided in § 381.187(d) of this part. are counted when calculating the total (d) An establishment that meets the number of employees. conditions in paragraph (a) of this sec- (3) The average number of employees tion and that is not an ineligible estab- is calculated for each of the pay peri- lishment under paragraph (c) of this ods for the preceding 12 calendar section may apply for selection into a months. cooperative interstate shipment pro- (4) Part-time and temporary employ- gram through the State in which the ees are counted the same as full-time establishment is located. employees. (5) If the establishment has not been [76 FR 24756, May 2, 2011; 76 FR 81360, Dec. 28, in business for 12 months, the average 2011] number of employees is calculated for § 381.514 State request for cooperative each of the pay periods in which the es- agreement. tablishment has been in business. (6) Volunteers who receive no com- (a) State participation in a coopera- pensation are not considered employees tive interstate shipment program unless their duties involve handling under this subpart is limited to States the poultry products prepared by the that have implemented cooperative establishment. State poultry products inspection pro- (7) The total number of employees grams. can never exceed 35 individuals at any (b) To request an agreement for a co- given time, regardless of the average operative interstate shipment program number of employees. under this subpart, a State must sub- (c) The following establishments are mit a written request to the Adminis- ineligible to participate in a coopera- trator through the FSIS District Office tive interstate shipment program: for the FSIS District in which the (1) Establishments that employ more State is located. In the request the than 25 employees on average (except State must: as provided under paragraph (a)(2) of (1) Identify establishments in the this section); State that have requested to be se- (2) Establishments operating under a lected for the program that the State Federal-State program as provided in recommends for initial selection into § 381.186 of this part as of June 18, 2008; the program, if any; (3) Official establishments; (2) Demonstrate that the State is (4) Establishments that were official able to provide the necessary inspec- establishments as of June 18, 2008, but tion services to selected establish- that were re-organized on a later date ments in the State and conduct any re- by the person that controlled the es- lated activities that would be required tablishment as of June 18, 2008; under a cooperative interstate ship- (5) Establishments operating under a ment program established under this cooperative State poultry products in- subpart; and spection program that employed more (3) Agree that, if the State enters than 35 employees as of June 18, 2008, into an agreement with FSIS for a co- that were reorganized on a later date operative interstate shipment program, by the person that controlled the es- the State will: tablishment as of June 18, 2008; (i) Provide FSIS with access to the (6) Establishments that are the sub- results of all laboratory analyses con- ject of a transition under § 381.521 of ducted on product samples from se- this subpart; lected establishments in the State;

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(ii) Notify the selected establishment (5) Is in compliance with all require- coordinator for the State of the results ments under the Act and the imple- of any laboratory analyses that indi- menting regulations in this chapter. cate that a product prepared in a se- (b) To participate in a cooperative lected establishment may be adulter- interstate shipment program, an estab- ated or may otherwise present a food lishment that meets the conditions in safety concern; and paragraph (a) of this section must be (iii) When necessary, cooperate with selected by the Administrator, in co- FSIS to transition selected establish- ordination with the State where the es- ments in the State that have been tablishment is located. deselected from a cooperative inter- (c) If an establishment is selected to state shipment program to become offi- participate in a cooperative interstate cial establishments. shipment program as provided in para- (c) If the Administrator determines graph (b) of this section, the State is to that a State that has submitted a re- assign the establishment an official quest to participate in a cooperative number that reflects the establish- interstate shipment program qualifies ment’s participation in the cooperative to enter into a cooperative agreement interstate shipment program and ad- for such a program, the Administrator vise the FSIS selected establishment and the State will sign a cooperative coordinator for the State of the official agreement that sets forth the terms number assigned to each selected es- and conditions under which each party tablishment in the State. The official will cooperate to provide inspection numbers assigned to every selected es- services to selected establishments lo- tablishment must contain a suffix, e.g., cated in the State. ‘‘SE,’’ that identifies the establishment (d) After the Administrator and a as a selected establishment; that in- State have signed an agreement for a cludes the letter ‘‘P,’’ which identifies cooperative interstate shipment pro- the establishment as a poultry estab- gram as provided in paragraph (c) of lishment; and that identifies the State, this section, the Administrator will: e.g., ‘‘SEPND,’’ for ‘‘selected establish- (1) Appoint an FSIS employee as the ment poultry North Dakota.’’ FSIS selected establishment coordi- (d) Failure of a State to comply with nator for the State and paragraph (c) of this section will dis- (2) Coordinate with the State to se- qualify the State from participation in lect establishments to participate in the cooperative interstate shipment the program as provided in § 381.515(b) program. of this subpart. § 381.516 Commencement of a coopera- § 381.515 Establishment selection; offi- tive interstate shipment program; cial number for selected establish- inspection by designated personnel ments. and official mark. (a) An establishment operating under (a) A cooperative interstate shipment a cooperative State poultry products program will commence when the Ad- inspection program will qualify for se- ministrator, in coordination with the lection into a cooperative interstate State, has selected establishments in shipment program if the establish- the State to participate in the pro- ment: gram. (1) Has submitted a request to the (b) Inspection services for selected State to be selected for the program; establishments participating in a coop- (2) Has the appropriate number of erative interstate shipment program employees under § 381.513(a) of this sub- must be provided by designated per- part; sonnel, who will be under the direct su- (3) Is not ineligible to participate in pervision of a State employee. a cooperative interstate shipment pro- (c) Poultry products processed in a gram under § 381.513(c) of this subpart; selected establishment and inspected (4) Is in compliance with all require- and passed by designated State per- ments under the cooperative State sonnel must bear an official Federal poultry products inspection program; mark, stamp, tag, or label of inspection and in the appropriate form prescribed in

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subpart M of this part that includes manner that complies with the Act and the information specified in § 381.515(c) the implementing regulations in this of this subpart. chapter; (d) Poultry products processed in a (3) Verifying that that the State selected establishment that comply staffing levels for each selected estab- with the conditions in paragraph (c) of lishments are appropriate to carry out this section may be distributed in the required inspection activities; and interstate commerce. (4) Assessing each selected establishment’s compliance with the Act and § 381.517 Federal oversight of a coop- implementing regulations in this chap- erative interstate shipment pro- ter. gram. (c) If the selected establishment co- (a) The FSIS selected establishment ordinator determines that designated coordinator for a State that has en- personnel are providing inspection tered into an agreement for a coopera- services to selected establishments in tive interstate shipment program will the State in a manner that is incon- visit each selected establishment in sistent with the Acts and the imple- the State on a regular basis to verify menting regulations in this chapter, that the establishment is operating in the Administrator will provide an op- a manner that is consistent with the portunity for the State to develop and Act and the implementing regulations implement a corrective action plan to in this chapter. The frequency with address inspection deficiencies identi- which the SEC will visit selected estab- fied by the selected establishment co- lishments under the SEC’s jurisdiction ordinator. If the State fails to develop will be based on factors that include, a corrective action plan, or the se- but are not limited to, the complexity lected establishment coordinator for of the operations conducted at the se- the State determines that the correc- lected establishment, the establish- tive action plan is inadequate, the Ad- ment’s schedule of operations, and the ministrator will terminate the agree- establishment’s performance under the ment for the cooperative interstate cooperative interstate shipment pro- shipment program as provided in gram. If necessary, the selected estab- § 381.187(d) of this part. lishment coordinator, in consultation with the District Manager that covers § 381.518 Quarterly reports. the State, may designate qualified (a) The selected establishment coor- FSIS personnel to visit a selected es- dinator will prepare a report on a quar- tablishment on behalf of the selected terly basis that describes the status of establishment coordinator. each selected establishment under his (b) The selected establishment coor- or her jurisdiction. dinator, in coordination with the (b) The quarterly report required in State, will verify that selected estab- paragraph (a) of this section will: lishments in the State are receiving (1) Include the selected establish- the necessary inspection services from ment coordinator’s assessment of the designated personnel, and that these performance of the designated per- establishments are eligible, and remain sonnel in conducting inspection activi- eligible, to participate in a cooperative ties at selected establishments and interstate shipment program. The se- (2) Identify those selected establish- lected establishment coordinator’s ment that the selected establishment verification activities may include: coordinator has verified are in compli- (1) Verifying that each selected es- ance with the Act and implementing tablishment employs, and continues to regulations in this chapter, those that employ, 25 or fewer employees, on aver- have been deselected under § 381.520 of age, as required under § 381.513(a) of this subpart, and those that are this part, unless the establishment is transitioning to become official estab- transitioning to become an official es- lishments under § 381.521 of this sub- tablishment; part. (2) Verifying that the designated per- (c) The selected establishment coor- sonnel are providing inspection serv- dinator is to submit the quarterly re- ices to selected establishments in a port to the Administrator through the

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District Manager for the State where § 381.520 Deselection of ineligible es- the selected establishments identified tablishments. in the report are located. (a) The Administrator will deselect a selected establishment that becomes § 381.519 Enforcement authority. ineligible to participate in a coopera- (a) To facilitate oversight and en- tive interstate shipment program for forcement of this subpart, selected es- any reason listed under § 381.513(c) of tablishments operating under a cooper- this subpart. ative interstate shipment program (b) An establishment that has been must, upon request, give the FSIS se- deselected must transition to become lected establishment coordinator or an official establishment as provided in § 381.521 of this subpart. other FSIS officials access to all establishment records required under the § 381.521 Transition to official estab- Act and the implementing regulations lishment. in this chapter. The Administrator (a) If an establishment is deselected may deselect any selected establish- from a cooperative interstate shipment ment that refuses to comply with this program as provided in § 381.520 of this paragraph. subpart, FSIS, in coordination with the (b) Selected establishment coordina- State where the establishment is lo- tors may initiate any appropriate en- cated, will develop and implement a forcement action provided for in part plan to transition the establishment to 500 of this chapter if they determine become an official establishment. Ex- that a selected establishment under cept that an establishment that was their jurisdiction is operating in man- deselected from a cooperative inter- ner that is inconsistent with the Act state shipment program because it is and the implementing regulations in located in a State whose agreement for this chapter. Selected establishments such a program was terminated may ei- participating in a cooperative inter- ther transition to become an official establishment or transition to become state shipment program are subject to a State-inspected establishment under the notification and appeal procedures the cooperative State poultry products set out in part 500 of this chapter. inspection program. (c) If inspection at a selected estab- (b) An establishment that has been lishment is suspended for any of the deselected from a cooperative inter- reasons specified in § 500.3 or § 500.4 of state shipment program and success- this chapter, FSIS will: fully transitioned to become an official (1) Provide an opportunity for the es- establishment may withdraw from the tablishment to implement corrective Federal inspection program and resume actions and remain in the cooperative operations under the cooperative State interstate shipment program, or poultry products inspection program (2) Move to deselect the establish- after operating as an official establishment as provided in § 381.520 of this sub- ment in full compliance with the Act part. for a year. (d) The decision to deselect a selected § 381.522 Transition grants. establishment under a suspension will be made on a case-by-case basis. In (a) Transition grants are funds that a making this decision, FSIS, in con- State participating in a cooperative sultation with the State where the se- interstate shipment program under this subpart may apply for to reim- lected establishment is located, will burse selected establishments in the consider, among other factors: State for the cost to train one indi- (1) The non-compliance that led to vidual in the seven HACCP principles the suspension; for meat or poultry processing as re- (2) The selected establishment’s com- quired under § 417.7 of this chapter and pliance history; and associated training in the development (3) The corrective actions proposed of sanitation standard operating proce- by the selected establishment. dures required under part 416 of this chapter.

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(b) A State participating in a cooper- § 381.524 Voluntary withdrawal. ative interstate shipment program that A selected establishment that is in receives a transition grant must use grant funds to reimburse the training full compliance with the requirements costs of one employee per each selected in this part may voluntarily end its establishment in the State. Any other participation in a cooperative inter- use of such funds is prohibited. state shipment program and operate under the cooperative State poultry § 381.523 Separation of operations. products inspection program. Estab- A selected establishment may con- lishments that voluntarily end their duct operations under the cooperative participation in the cooperative may State poultry products inspection pro- re-apply for the program after oper- gram if the establishment implements ating under the cooperative State poul- and maintains written procedures for try products inspection program for complete physical separation of prod- one year. uct and process for each operation by time or space.

SUBCHAPTERS B–C [RESERVED]

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PART 390—FREEDOM OF INFOR- Governmental and Public Affairs, or at MATION AND PUBLIC INFORMA- established rates from the Super- TION intendent of Documents, U.S. Govern- ment Printing Office, Washington, Sec. 20402–9328. 390.1 Scope and purpose. 390.2 Published materials. § 390.3 Indexes, reference guide, and 390.3 Indexes, reference guide, and hand- handbook. book. (a) Pursuant to the regulations in 7 390.4 Facilities for inspection and copying. 390.5 Requests for records. CFR 1.4(c), FSIS will maintain and 390.6 Fee schedule. make available for public inspection 390.7 Appeals. and copying an index providing identi- 390.8 Agency response to requests. fying information regarding the mate- 390.9 Communications with State and other rials required to be published or made Federal government agencies. available under the Freedom of Infor- 390.10 Availability of Lists of Retail Con- signees during Meat or Poultry Product mation Act (5 U.S.C. 552(a)(2)). The Recalls. Agency will make the index available by computer telecommunications by AUTHORITY: 5 U.S.C. 301, 552; 21 U.S.C. 451– December 31, 1999. Quarterly publica- 471, 601–695; 7 CFR 1.3, 2.7. tion of the index is unnecessary and SOURCE: 64 FR 43903, Aug. 12, 1999, unless impractical, since the material is volu- otherwise noted. minous and does not change often § 390.1 Scope and purpose. enough to justify the expense of quarterly publication. The Agency will pro- This part is issued pursuant to the vide copies of any index, upon request, Freedom of Information Act (FOIA) as at a cost not to exceed direct cost of amended (5 U.S.C. 552), and in accord- duplication. ance with the directives of the Depart- (b) FSIS is responsible for preparing ment of Agriculture regulations in part reference material or a guide for re- 1, subpart A, of Title 7. The availability of records, including electronic questing records or information from records created on or after November 1, the Agency. This guide also will in- 1996, of the Food Safety and Inspection clude an index of all major information Service (FSIS), and the procedures by systems and a description of major in- which the public may request such information and record locator systems. formation, will be governed by the (c) FSIS will prepare a handbook for FOIA and by the Department regula- obtaining information from the Agen- tions as implemented and supple- cy. The handbook will be available on mented by the regulations in this part. paper and through electronic means, and will discuss how the public can use § 390.2 Published materials. it to access Agency FOIA annual re- FSIS rules and regulations relating ports. Similarly, the annual reports to its regulatory responsibilities and will refer to the handbook and how to administrative procedures are pub- obtain it. lished and made available to the public in the FEDERAL REGISTER and codified § 390.4 Facilities for inspection and in chapter III, title 9, of the Code of copying. Federal Regulations. FSIS also issues Facilities for public inspection and numerous publications relating to copying of the material described in Agency programs, which implement §§ 390.2 and 390.3 of this part will be pro- the laws listed in the Delegation of Au- vided by FSIS pursuant to 7 CFR 1.5(a) thority, 7 CFR 2.15(a). Most of these in a reading area, on business days be- publications are available free from the tween the hours of 8:30 a.m. and 4:30 USDA Publications Division, Office of p.m., upon request to the Freedom of

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Information Coordinator or designee at document will be released with the the following address: nondisclosable portions deleted. The Coordinator or designee may exercise Freedom of Information Act Coordinator (FOIA), Food Safety and Inspection Serv- discretion as limited by 7 CFR l.15 to ice, Department of Agriculture, Wash- release the entire document or make ington, DC 20250–3700 only a minimum number of deletions. If portions of a document in electronic § 390.5 Request for records. format have been redacted, the Agency (a) The FOIA Coordinator of FSIS is must indicate, on the released portion authorized to receive requests and to of the document, the amount of infor- exercise authority under 7 CFR 1.3(a) mation that has been deleted from a to— record, unless that indication would (1) Make determinations to grant or harm an interest protected by an appli- deny such requests, cable exemption. (2) Extend the 20-day deadline, (3) Make discretionary releases of ex- § 390.6 Fee schedule. empt records, except where disclosure Department regulations provide for a is specifically prohibited by Executive schedule of reasonable standard Order, statute, and applicable regula- charges for document search and dupli- tions, cation. See 7 CFR 1.17. Fees to be (4) Consider expedited processing charged are in 7 CFR part 1, subpart A, when appropriate, appendix A. (5) Make determinations regarding the charging of fees pursuant to the es- § 390.7 Appeals. tablished schedule, and (a) If the request for information or (6) Determine the applicability of 7 for a waiver of search or duplication is CFR 1.5 to requests for records. denied, in whole or in part, the FOIA (b) Requests for FSIS records or in- Coordinator or designee will explain in formation will be made in writing in the letter of response the grounds for accordance with 7 CFR 1.5 and sub- any denial of access and offer the remitted to the FSIS Freedom of Infor- quester an opportunity to file an ad- mation Act Coordinator at the fol- ministrative appeal, pursuant to 7 CFR lowing address: 1.3(a)(4). The appeal should be filed in Freedom of Information Act Coordinator writing within 45 days of the date of (FOIA Request), Food Safety and Inspec- denial (departmental regulations, 7 tion Service, Department of Agriculture, CFR 1.14) and addressed as follows: Washington, DC 20250–3700 Administrator, Food Safety and Inspection The submitter will identify each Service (FOIA Appeals), Department of Ag- record with reasonable specificity as riculture, Washington, DC 20250–3700 prescribed in 7 CFR 1.3. All requests to inspect or obtain copies of any record (b) The FSIS Administrator is au- or to obtain a fee waiver must be sub- thorized under 7 CFR 1.3(a)(4) to extend mitted in writing. the 20-day deadline, make discre- (c) In exercising authority under 7 tionary releases, and make determina- CFR 1.3(a)(3) to grant and deny re- tions regarding the charging of fees. quests, the Coordinator or designee will comply with subsection (b) of the § 390.8 Agency response to requests. Freedom of Information Act (5 U.S.C. (a) The response to Freedom of Infor- 552(b)), as amended, which requires mation requests and appeals by offi- that any reasonably segregated portion cials named in §§ 390.5 and 390.7 of this of a document will be provided to a per- part shall be governed by and made in son requesting the document after de- accordance with 7 CFR 1.7 and the reg- letion of any portions within the scope ulations in this part. of the request for which an exemption (b) If requests for records and infor- is being claimed under the Act. There- mation are received by field offices, the fore, unless the disclosable and field office will immediately notify the nondisclosable portions are so inex- FOIA Coordinator or designee by tele- tricably linked that it is not reason- phone and transmit the request to the ably possible to separate them, the FOIA office. In rare instances, the

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FOIA Coordinator or designee will au- § 390.10 Availability of Lists of Retail thorize a release of the requested Consignees during Meat or Poultry records to the field office receiving the Product Recalls. request. The request will be considered The Administrator of the Food Safe- as having been received on the date of ty and Inspection Service will make arrival in the office of the Coordinator publicly available the names and loca- or designee. Any person whose request tions of retail consignees of recalled for records has been granted may in- meat or poultry products that the spect and copy the records (or copies) Agency compiles in connection with a at the office listed in § 390.4 of this part recall where there is a reasonable prob- in accordance with the provisions of ability that the use of the product that section and with § 390.6. Copies also may be obtained by mail. could cause serious adverse health consequences or death. § 390.9 Communications with State [73 FR 40948, July 17, 2008] and other Federal government agencies. (a) The Administrator of the Food PART 391—FEES AND CHARGES Safety and Inspection Service (FSIS), FOR INSPECTION SERVICES AND or designee, may authorize the disclo- LABORATORY ACCREDITATION sure of distribution lists (records that show where and when product was Sec. shipped) obtained from a firm recalling 391.1 Scope and purpose. products, or incorporated into agency- 391.2 Basetime rate. prepared records, to State and other 391.3 Overtime and holiday rates. Federal government agencies to verify 391.4 Laboratory services rate. the removal of the recalled product, 391.5 Laboratory accreditation fees. provided that: AUTHORITY: 7 U.S.C. 138f; 7 U.S.C. 1622, 1627 (1) The State agency has provided and 2219a; 21 U.S.C. 451 et seq.; 21 U.S.C. 601– both a written statement establishing 695; 7 CFR 2.18 and 2.53. its authority to protect confidential distribution lists from public disclo- § 391.1 Scope and purpose. sure and a written commitment not to Fees shall be charged by the Agency disclose any information provided by for certain specified inspection services FSIS, without the written permission provided on a holiday, on an overtime of the submitter of the information or basis, and/or which are voluntary in- written confirmation by FSIS that the spection services. information no longer has confidential status. Federal government agencies [54 FR 6390, Feb. 10, 1989] must provide a written commitment not to disclose the information and to § 391.2 Basetime rate. refer any request for distribution lists (a) For each calendar year, FSIS will to FSIS for response; and calculate the basetime rate for inspec- (2) The Administrator of FSIS or des- tion services, per hour per program em- ignee determines that disclosure would ployee, provided pursuant to §§ 350.7, be in the interest of public health. 351.8, 351.9, 352.5, 354.101, 355.12, and (b) This provision does not authorize 362.5 of this chapter, using the fol- the disclosure to State or other Fed- lowing formula: The quotient of divid- eral government agencies of trade se- ing the Office of Field Operations plus cret information, unless otherwise pro- Office of International Affairs inspec- vided by law or pursuant to an express tion program personnel’s previous fis- written authorization provided by the cal year’s regular direct pay by the submitter of the information. previous fiscal year’s regular hours, (c) Information disclosed under this plus the quotient multiplied by the cal- section is not a disclosure of informa- endar year’s percentage of cost of liv- tion to the public. Disclosures made ing increase, plus the benefits rate, under this section do not waive any plus the travel and operating rate, plus FOIA exemption protection. the overhead rate, plus the allowance [67 FR 20013, Apr. 24, 2002] for bad debt rate.

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(b) FSIS will calculate the benefits, § 391.3 Overtime and holiday rates. travel and operating, overhead, and al- For each calendar year, FSIS will lowance for bad debt rate components calculate the overtime and holiday of the basetime rate, using the fol- rates, per hour per program employee, lowing formulas: provided pursuant to §§ 307.5, 350.7, (1) Benefits rate. The quotient of di- 351.8, 351.9, 352.5, 354.101, 355.12, 362.5, viding the previous fiscal year’s direct and 381.38 of this chapter, using the fol- benefits costs by the previous fiscal lowing formulas: year’s total hours (regular, overtime, (a) Overtime rate. The quotient of di- and holiday), plus the quotient multi- viding the Office of Field Operations plied by the calendar year’s percentage plus Office of International Affairs in- cost of living increase. Some examples spection program personnel’s previous of direct benefits are health insurance, fiscal year’s regular direct pay by the retirement, life insurance, and Thrift previous fiscal year’s regular hours, Savings Plan basic and matching con- plus the quotient multiplied by the cal- tributions. endar year’s percentage of cost of liv- (2) Travel and operating rate. The ing increase, multiplied by 1.5, plus the quotient of dividing the previous fiscal benefits rate, plus the travel and oper- year’s total direct travel and operating ating rate, plus the overhead rate, plus costs by the previous fiscal year’s total the allowance for bad debt rate. hours (regular, overtime, and holiday), (b) Holiday rate. The quotient of di- plus the quotient multiplied by the cal- viding the Office of Field Operations endar year’s percentage of inflation. plus Office of International Affairs in- (3) Overhead rate. The quotient of di- spection program personnel’s previous viding the previous fiscal year’s indi- fiscal year’s regular direct pay by the rect costs plus the previous fiscal previous fiscal year’s regular hours, year’s information technology (IT) plus the quotient multiplied by the cal- costs in the Public Health Data Com- endar year’s percentage of cost of liv- munication Infrastructure System ing increase, multiplied by 2, plus the Fund plus the previous fiscal year’s Of- benefits rate, plus the travel and oper- fice of Management Program cost in ating rate, plus the overhead rate, plus the Reimbursable and Voluntary Funds the allowance for bad debt rate. plus the provision for the operating (c) FSIS will calculate the benefits balance less any Greenbook costs (i.e., rate, the travel and operating rate, the costs of USDA support services pro- overhead rate, and the allowance for rated to the service component for bad debt rate using the formulas set which the fees are charged) that are forth in § 391.2(b), and the cost of living not related to food inspection, by the increases and percentage of inflation previous fiscal year’s total hours (reg- factors set forth in § 391.2(c). ular, overtime, and holiday) worked across all funds, plus the quotient mul- [76 FR 20227, Apr. 12, 2011] tiplied by the calendar year’s percent- § 391.4 Laboratory services rate. age of inflation. (4) Allowance for bad debt rate. Pre- (a) For each calendar year, FSIS will vious fiscal year’s allowance for bad calculate the laboratory services rate, debt (for example, debt owed that is per hour per program employee, pro- not paid in full by plants and establish- vided pursuant to §§ 350.7, 351.9, 352.5, ments that declare bankruptcy) di- 354.101, 355.12, and 362.5 of this chapter, vided by the previous fiscal year’s total using the following formula: The hours (regular, overtime, and holiday) quotient of dividing the Office of Pub- worked. lic Health Science (OPHS) previous fiscal year’s regular direct pay by OPHS (c) The calendar year’s cost of living previous fiscal year’s regular hours, increases and percentage of inflation plus the quotient multiplied by the cal- factors used in the formulas in this sec- endar year’s percentage cost of living tion are based on the Office of Manage- increase, plus the benefits rate, plus ment and Budget’s Presidential Eco- the travel and operating rate, plus the nomic Assumptions. overhead rate, plus the allowance for [76 FR 20227, Apr. 12, 2011] bad debt rate.

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(b) FSIS will calculate the benefits amend, or repeal a regulation adminis- rate, the travel and operating rate, the tered by FSIS. A request to issue, overhead rate, and the allowance for amend, or repeal a document that in- bad debt rate using the formulas set terprets a regulation administered by forth in § 391.2(b), and the cost of living FSIS may also be submitted by peti- increases and percentage of inflation tion. factors set forth in § 391.2(c). § 392.3 Required information. [76 FR 20228, Apr. 12, 2011] To be considered by FSIS, a petition § 391.5 Laboratory accreditation fees. must contain the following informa- (a) The annual fee for the initial action: creditation and maintenance of accred- (a) The name, address, telephone itation provided pursuant to § 439.5 of number, and e-mail address (if avail- this chapter shall be $4,500.00 for fiscal able) of the person who is submitting year 2011; and $5,000.00 for fiscal years the petition; 2012 and 2013. (b) A full statement of the action re- (b) Laboratories that request special quested by the petitioner, including onsite inspections shall pay FSIS the the exact wording and citation of the actual cost of reasonable travel and existing regulation, if any, and the pro- other expenses necessary to perform posed regulation or amendment re- the unscheduled or non-routine onsite quested; inspections. (c) A full statement of the factual and legal basis on which the petitioner [58 FR 65269, Dec. 13, 1993 as amended at 59 relies for the action requested in the FR 66449, Dec 27, 1994; 64 FR 19868, Apr. 23, petition, including all relevant infor- 1999; 71 FR 2143, Jan. 13, 2006; 76 FR 20228, Apr. 12, 2011] mation and views on which the petitioner relies, as well as information known to the petitioner that is unfa- PART 392—PETITIONS FOR vorable to the petitioner’s position. RULEMAKING The statement should identify the problem that the requested action is Sec. intended to address and explain why 392.1 Scope and purpose. 392.2 Definition of petition. the requested action is necessary to ad- 392.3 Required information. dress the problem. 392.4 Supporting documentation. 392.5 Filing procedures. § 392.4 Supporting documentation. 392.6 Public display. (a) Information referred to or relied 392.7 Comments. on in support of a petition should be in- 392.8 Expedited review. 392.9 Availability of additional guidance. cluded in full and should not be incorporated by reference. A copy of any ar- AUTHORITY: 5 U.S.C. 553(e), 7 CFR 1.28. ticle or other source cited in a petition SOURCE: 74 FR 16107, Apr. 9, 2009, unless should be submitted with the petition. otherwise noted. (b) Sources of information that are appropriate to use in support of a peti- § 392.1 Scope and purpose. tion include, but are not limited to: This part contains provisions gov- (1) professional journal articles, erning the submission of petitions for (2) research reports, rulemaking to the Food Safety and In- (3) official government statistics, spection Service (FSIS). The provisions (4) official government reports, in this part apply to all rulemaking pe- (5) industry data, and titions submitted to FSIS, except to (6) scientific textbooks. the extent that other parts or sections (c) If an original research report is of this chapter prescribe procedures for used to support a petition, the informa- submitting a request to amend a par- tion should be presented in a form that ticular regulation. would be acceptable for publication in a peer reviewed scientific or technical § 392.2 Definition of petition. journal. For purposes of this part, a ‘‘peti- (d) If quantitative data are used to tion’’ is a written request to issue, support a petition, the presentation of

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the data should include a complete sta- will consider the information to be tistical analysis using conventional confidential. statistical methods. (c) If FSIS determines that a petition, or any documentation submitted § 392.5 Filing procedures. in support of a petition, contains infor- (a) Any interested person may file a mation that is exempt from public dis- petition with FSIS. For purposes of closure under the Freedom of Informa- this part, an ‘‘interested person’’ is any tion Act (5 U.S.C. 552 et seq.) or any individual, partnership, corporation, other applicable laws or regulations, association, or public or private orga- and that the information would provide nization. the basis for granting the petition, FSIS will inform the petitioner in writ- (b) To file a petition with FSIS, a ing. FSIS will provide the petitioner an person should submit the petition to opportunity to withdraw the petition the FSIS Docket Clerk, Department of or supporting documentation, or mod- Agriculture, Food Safety and Inspec- ify the supporting documentation to tion Service, Room 2534 South Build- permit public disclosure. ing, 1400 Independence Ave., SW., Washington, DC 20250–3700. § 392.7 Comments. (c) Once a petition is submitted in ac- (a) Any interested person may sub- cordance with this part, it will be filed mit written comments on a petition by the FSIS Docket Clerk, stamped filed with FSIS. with the date of filing, and assigned a (b) Comments on a petition should be petition number. Once a petition has submitted within 60 days of the posting been filed, FSIS will notify the peti- date of the petition and should identify tioner in writing and provide the peti- the number assigned to the petition to tioner with the number assigned to the which the comments refer. petition and the Agency contact for (c) FSIS will consider all timely com- the petition. The petition number ments on a petition that are submitted should be referenced by the petitioner in accordance with this section as part in all contacts with the Agency regard- of its review of the petition. ing the petition. (d) All comments on a petition will (d) If a petitioner elects to withdraw become part of the petition file and a petition submitted in accordance will be available for public inspection with this part, the petitioner should in- in the FSIS docket room and posted on form FSIS in writing. Once a petition the FSIS Web site at http:// has been withdrawn, the petitioner www.fsis.usda.gov/. may re-submit the petition at any (e) Any interested person who wishes time. to suggest an alternative action to the action requested by the petition should § 392.6 Public display. submit a separate petition that com- (a) All rulemaking petitions filed plies with these regulations and not with FSIS, along with any documenta- submit the alternative as a comment tion submitted in support of a petition, on the petition. will be available for public inspection (f) If FSIS determines that a com- in the FSIS docket room and will be ment received on a petition is in fact a posted on the FSIS Web site at http:// request for an alternative action, the www.fsis.usda.gov/. Agency will inform the commenter in (b) If FSIS cannot readily determine writing. The Agency will take no fur- whether information submitted in sup- ther action on the requested alter- port of a petition is privileged or con- native action unless the commenter fidential business information, FSIS submits an appropriate petition for will request that the petitioner submit rulemaking. a written statement that certifies that the petition does not contain confiden- § 392.8 Expedited review. tial information that should not be put (a) A petition will receive expedited on public display. If the petitioner fails review by FSIS if the requested action to submit the certification within a is intended to enhance the public time specified by FSIS, the Agency health by removing or reducing

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foodborne pathogens or other potential (c) If FSIS determines that a petition food safety hazards that might be warrants expedited review, FSIS will present in or on meat, poultry, or egg review the petition ahead of other products. pending petitions. (b) For a petition to be considered for expedited review, the petitioner must § 392.9 Availability of additional guid- submit scientific information that ance. demonstrates that the requested action Information related to the submis- will reduce or remove foodborne patho- sion and processing of petitions for gens or other potential food safety haz- rulemaking may be found on the FSIS ards that are likely to be present in or Web site at http://www/fsis.usda.gov/. on meat, poultry, or egg products, and how it will do so.

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PART 416—SANITATION product in a manner that does not result in product adulteration or the cre- Sec. ation of insanitary conditions. 416.1 General rules. (2) Walls, floors, and ceilings within 416.2 Establishment grounds and facilities. establishments must be built of dura- 416.3 Equipment and utensils. ble materials impervious to moisture 416.4 Sanitary operations. and be cleaned and sanitized as nec- 416.5 Employee hygiene. 416.6 Tagging insanitary equipment, uten- essary to prevent adulteration of prod- sils, rooms or compartments. uct or the creation of insanitary condi- 416.11 General rules. tions. 416.12 Development of sanitation SOP’s. (3) Walls, floors, ceilings, doors, win- 416.13 Implementation of SOP’s. dows, and other outside openings must 416.14 Maintenance of Sanitation SOP’s. be constructed and maintained to pre- 416.15 Corrective Actions. vent the entrance of vermin, such as 416.16 Recordkeeping requirements. 416.17 Agency verification. flies, rats, and mice. (4) Rooms or compartments in which AUTHORITY: 21 U.S.C. 451–470, 601–695; 7 edible product is processed, handled, or U.S.C. 450, 1901–1906; 7 CFR 2.18, 2.53. stored must be separate and distinct SOURCE: 61 FR 38868, July 25, 1996, unless from rooms or compartments in which otherwise noted. inedible product is processed, handled, or stored, to the extent necessary to § 416.1 General rules. prevent product adulteration and the Each official establishment must be creation of insanitary conditions. operated and maintained in a manner (c) Light. Lighting of good quality sufficient to prevent the creation of in- and sufficient intensity to ensure that sanitary conditions and to ensure that sanitary conditions are maintained and product is not adulterated. that product is not adulterated must [64 FR 56417, Oct. 20, 1999] be provided in areas where food is processed, handled, stored, or examined; § 416.2 Establishment grounds and fa- where equipment and utensils are cilities. cleaned; and in hand-washing areas, (a) Grounds and pest control. The dressing and locker rooms, and toilets. grounds about an establishment must (d) Ventilation. Ventilation adequate be maintained to prevent conditions to control odors, vapors, and condensa- that could lead to insanitary condition to the extent necessary to prevent tions, adulteration of product, or inter- adulteration of product and the cre- fere with inspection by FSIS program ation of insanitary conditions must be employees. Establishments must have provided. in place a pest management program to (e) Plumbing. Plumbing systems must prevent the harborage and breeding of be installed and maintained to: pests on the grounds and within estab- (1) Carry sufficient quantities of lishment facilities. Pest control sub- water to required locations throughout stances used must be safe and effective the establishment; under the conditions of use and not be (2) Properly convey sewage and liquid applied or stored in a manner that will disposable waste from the establish- result in the adulteration of product or ment; the creation of insanitary conditions. (3) Prevent adulteration of product, (b) Construction. (1) Establishment water supplies, equipment, and utensils buildings, including their structures, and prevent the creation of insanitary rooms, and compartments must be of conditions throughout the establish- sound construction, be kept in good re- ment; pair, and be of sufficient size to allow (4) Provide adequate floor drainage in for processing, handling, and storage of all areas where floors are subject to

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flooding-type cleaning or where normal used for the same purpose provided operations release or discharge water that measures are taken to reduce or other liquid waste on the floor; physical, chemical, and micro- (5) Prevent back-flow conditions in biological contamination so as to pre- and cross-connection between piping vent contamination or adulteration of systems that discharge waste water or product. Reuse that which has come sewage and piping systems that carry into contact with raw product may not water for product manufacturing; and be used on ready-to-eat product. (6) Prevent the backup of sewer (4) Reconditioned water that has gases. never contained human waste and that (f) Sewage disposal. Sewage must be has been treated by an onsite advanced disposed into a sewage system separate wastewater treatment facility may be from all other drainage lines or dis- used on raw product, except in product posed of through other means suffi- formulation, and throughout the facil- cient to prevent backup of sewage into ity in edible and inedible production areas where product is processed, han- areas, provided that measures are dled, or stored. When the sewage dis- taken to ensure that this water meets posal system is a private system re- the criteria prescribed in paragraph quiring approval by a State or local (g)(1) of this section. Product, facili- health authority, the establishment ties, equipment, and utensils coming in must furnish FSIS with the letter of contact with this water must undergo a approval from that authority upon re- separate final rinse with non-recondi- quest. tioned water that meets the criteria (g) Water supply and water, ice, and so- prescribed in paragraph (g)(1) of this lution reuse. (1) A supply of running section. water that complies with the National (5) Any water that has never con- Primary Drinking Water regulations tained human waste and that is free of (40 CFR part 141), at a suitable tem- pathogenic organisms may be used in perature and under pressure as needed, edible and inedible product areas, pro- must be provided in all areas where re- vided it does not contact edible prod- quired (for processing product, for uct. For example, such reuse water cleaning rooms and equipment, uten- may be used to move heavy solids, to sils, and packaging materials, for em- flush the bottom of open evisceration ployee sanitary facilities, etc.). If an troughs, or to wash antemortem areas, establishment uses a municipal water livestock pens, trucks, poultry cages, supply, it must make available to picker aprons, picking room floors, and FSIS, upon request, a water report, similar areas within the establishment. issued under the authority of the State (6) Water that does not meet the use or local health agency, certifying or at- conditions of paragraphs (g)(1) through testing to the potability of the water (g)(5) of this section may not be used in supply. If an establishment uses a pri- areas where edible product is handled vate well for its water supply, it must or prepared or in any manner that make available to FSIS, upon request, would allow it to adulterate edible documentation certifying the pota- product or create insanitary condi- bility of the water supply that has been tions. renewed at least semi-annually. (h) Dressing rooms, lavatories, and toi- (2) Water, ice, and solutions (such as lets. (1) Dressing rooms, toilet rooms, brine, liquid smoke, or propylene gly- and urinals must be sufficient in num- col) used to chill or cook ready-to-eat ber, ample in size, conveniently lo- product may be reused for the same cated, and maintained in a sanitary purpose, provided that they are main- condition and in good repair at all tained free of pathogenic organisms times to ensure cleanliness of all per- and fecal coliform organisms and that sons handling any product. They must other physical, chemical, and micro- be separate from the rooms and com- biological contamination have been re- partments in which products are proc- duced to prevent adulteration of prod- essed, stored, or handled. uct. (2) Lavatories with running hot and (3) Water, ice, and solutions used to cold water, soap, and towels, must be chill or wash raw product may be replaced in or near toilet and urinal

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rooms and at such other places in the (c) Cleaning compounds, sanitizing establishment as necessary to ensure agents, processing aids, and other cleanliness of all persons handling any chemicals used by an establishment product. must be safe and effective under the (3) Refuse receptacles must be con- conditions of use. Such chemicals must structed and maintained in a manner be used, handled, and stored in a man- that protects against the creation of ner that will not adulterate product or insanitary conditions and the adultera- create insanitary conditions. Docu- tion of product. mentation substantiating the safety of a chemical’s use in a food processing [64 FR 56417, Oct. 20, 1999] environment must be available to FSIS inspection program employees for re- § 416.3 Equipment and utensils. view. (a) Equipment and utensils used for (d) Product must be protected from processing or otherwise handling edible adulteration during processing, han- product or ingredients must be of such dling, storage, loading, and unloading material and construction to facilitate at and during transportation from offi- thorough cleaning and to ensure that cial establishments. their use will not cause the adulteration of product during processing, han- [64 FR 56417, Oct. 20, 1999] dling, or storage. Equipment and uten- § 416.5 Employee hygiene. sils must be maintained in sanitary condition so as not to adulterate prod- (a) Cleanliness. All persons working in uct. contact with product, food-contact surfaces, and product-packaging materials (b) Equipment and utensils must not must adhere to hygienic practices be constructed, located, or operated in while on duty to prevent adulteration a manner that prevents FSIS inspec- of product and the creation of insani- tion program employees from inspect- tary conditions. ing the equipment or utensils to deter- (b) Aprons, frocks, and mine whether they are in sanitary con- Clothing. other outer clothing worn by persons dition. who handle product must be of mate- (c) Receptacles used for storing ined- rial that is disposable or readily ible material must be of such material cleaned. Clean garments must be worn and construction that their use will at the start of each working day and not result in the adulteration of any garments must be changed during the edible product or in the creation of in- day as often as necessary to prevent sanitary conditions. Such receptacles adulteration of product and the cre- must not be used for storing any edible ation of insanitary conditions. product and must bear conspicuous and (c) Disease control. Any person who distinctive marking to identify per- has or appears to have an infectious mitted uses. disease, open lesion, including boils, [64 FR 56417, Oct. 20, 1999] sores, or infected wounds, or any other abnormal source of microbial contami- § 416.4 Sanitary operations. nation, must be excluded from any op- (a) All food-contact surfaces, includ- erations which could result in product ing food-contact surfaces of utensils adulteration and the creation of insani- and equipment, must be cleaned and tary conditions until the condition is sanitized as frequently as necessary to corrected. prevent the creation of insanitary con- [64 FR 56417, Oct. 20, 1999] ditions and the adulteration of product. § 416.6 Tagging insanitary equipment, (b) Non-food-contact surfaces of fa- utensils, rooms or compartments. cilities, equipment, and utensils used When an FSIS program employee in the operation of the establishment finds that any equipment, utensil, must be cleaned and sanitized as fre- room, or compartment at an official es- quently as necessary to prevent the tablishment is insanitary or that its creation of insanitary conditions and use could cause the adulteration of the adulteration of product. product, he will attach to it a ‘‘U.S.

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Rejected’’ tag. Equipment, utensils, Sanitation SOP’s at the frequencies rooms, or compartments so tagged can- specified. not be used until made acceptable. (c) Each official establishment shall Only an FSIS program employee may monitor daily the implementation of remove a ‘‘U.S. Rejected’’ tag. the procedures in the Sanitation [64 FR 56417, Oct. 20, 1999] SOP’s.

§ 416.11 General rules. § 416.14 Maintenance of Sanitation SOP’s. Each official establishment shall develop, implement, and maintain writ- Each official establishment shall rou- ten standard operating procedures for tinely evaluate the effectiveness of the sanitation (Sanitation SOP’s) in ac- Sanitation SOP’s and the procedures cordance with the requirements of this therein in preventing direct contami- part. nation or adulteration of product(s) and shall revise both as necessary to § 416.12 Development of Sanitation keep them effective and current with SOP’s. respect to changes in facilities, equip- (a) The Sanitation SOP’s shall de- ment, utensils, operations, or per- scribe all procedures an official estab- sonnel. lishment will conduct daily, before and during operations, sufficient to prevent § 416.15 Corrective Actions. direct contamination or adulteration (a) Each official establishment shall of product(s). take appropriate corrective action(s) (b) The Sanitation SOP’s shall be when either the establishment or FSIS signed and dated by the individual with determines that the establishment’s overall authority on-site or a higher Sanitation SOP’s or the procedures level official of the establishment. This specified therein, or the implementa- signature shall signify that the estab- tion or maintenance of the Sanitation lishment will implement the Sanita- SOP’s, may have failed to prevent dition SOP’s as specified and will main- rect contamination or adulteration of tain the Sanitation SOP’s in accord- product(s). ance with the requirements of this (b) Corrective actions include proce- part. The Sanitation SOP’s shall be dures to ensure appropriate disposition signed and dated upon initially imple- of product(s) that may be contami- menting the Sanitation SOP’s and nated, restore sanitary conditions, and upon any modification to the Sanita- prevent the recurrence of direct con- tion SOP’s. tamination or adulteration of prod- (c) Procedures in the Sanitation uct(s), including appropriate reevalua- SOP’s that are to be conducted prior to tion and modification of the Sanitation operations shall be identified as such, SOP’s and the procedures specified and shall address, at a minimum, the therein or appropriate improvements cleaning of food contact surfaces of fa- in the execution of the Sanitation cilities, equipment, and utensils. SOP’s or the procedures specified (d) The Sanitation SOP’s shall speci- therein. fy the frequency with which each procedure in the Sanitation SOP’s is to be [61 FR 38868, July 25, 1996, as amended at 62 conducted and identify the establish- FR 26219, May 13, 1997] ment employee(s) responsible for the implementation and maintenance of § 416.16 Recordkeeping requirements. such procedure(s). (a) Each official establishment shall maintain daily records sufficient to § 416.13 Implementation of SOP’s. document the implementation and (a) Each official establishment shall monitoring of the Sanitation SOP’s conduct the pre-operational procedures and any corrective actions taken. The in the Sanitation SOP’s before the establishment employee(s) specified in start of operations. the Sanitation SOP’s as being respon- (b) Each official establishment shall sible for the implementation and moni- conduct all other procedures in the toring of the procedure(s) specified in

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the Sanitation SOP’s shall authen- § 417.1 Definitions. ticate these records with his or her ini- For purposes of this part, the fol- tials and the date. lowing definitions shall apply: (b) Records required by this part may be maintained on computers provided Corrective action. Procedures to be fol- the establishment implements appro- lowed when a deviation occurs. priate controls to ensure the integrity Critical control point. A point, step, or of the electronic data. procedure in a food process at which (c) Records required by this part control can be applied and, as a result, shall be maintained for at least 6 a food safety hazard can be prevented, months and made accesable available eliminated, or reduced to acceptable to FSIS. All such records shall be levels. maintained at the official establish- Critical limit. The maximum or min- ment for 48 hours following comple- imum value to which a physical, bio- tion, after which they may be main- logical, or chemical hazard must be tained off-site provided such records controlled at a critical control point to can be made available to FSIS within prevent, eliminate, or reduce to an ac- 24 hours of request. ceptable level the occurrence of the identified food safety hazard. § 416.17 Agency verification. Food safety hazard. Any biological, FSIS shall verify the adequacy and chemical, or physical property that effectiveness of the Sanitation SOP’s may cause a food to be unsafe for and the procedures specified therein by human consumption. determining that they meet the re- HACCP System. The HACCP plan in quirements of this part. Such operation, including the HACCP plan verification may include: itself. (a) Reviewing the Sanitation SOP’s; Hazard. SEE Food Safety Hazard. (b) Reviewing the daily records docu- Preventive measure. Physical, chem- menting the implementation of the ical, or other means that can be used Sanitation SOP’s and the procedures to control an identified food safety haz- specified therein and any corrective ac- ard. tions taken or required to be taken; Process-monitoring instrument. An in- (c) Direct observation of the imple- strument or device used to indicate mentation of the Sanitation SOP’s and conditions during processing at a crit- the procedures specified therein and ical control point. any corrective actions taken or re- Responsible establishment official. The quired to be taken; and individual with overall authority on- (d) Direct observation or testing to site or a higher level official of the es- assess the sanitary conditions in the tablishment. establishment. § 417.2 Hazard Analysis and HACCP Plan. PART 417—HAZARD ANALYSIS AND CRITICAL CONTROL POINT (a) Hazard analysis. (1) Every official establishment shall conduct, or have (HACCP) SYSTEMS conducted for it, a hazard analysis to determine the food safety hazards rea- Sec. sonably likely to occur in the produc- 417.1 Definitions. 417.2 Hazard Analysis and HACCP plan. tion process and identify the preven- 417.3 Corrective actions. tive measures the establishment can 417.4 Validation, Verification, Reassess- apply to control those hazards. The ment. hazard analysis shall include food safe- 417.5 Records. ty hazards that can occur before, dur- 417.6 Inadequate HACCP Systems. ing, and after entry into the establish- 417.7 Training. ment. A food safety hazard that is rea- 417.8 Agency verification. sonably likely to occur is one for which AUTHORITY: 7 U.S.C. 450; 21 U.S.C. 451–470, a prudent establishment would estab- 601–695; 7 U.S.C. 1901–1906; 7 CFR 2.18, 2.53. lish controls because it historically has SOURCE: 61 FR 38868, July 25, 1996, unless occurred, or because there is a reason- otherwise noted. able possibility that it will occur in the

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particular type of product being proc- contamination if the product is pro- essed, in the absence of those controls. duced in accordance with the require- (2) A flow chart describing the steps ments of part 318, subpart G, or part of each process and product flow in the 381, subpart X, of this chapter. establishment shall be prepared, and (c) The contents of the HACCP plan. the intended use or consumers of the The HACCP plan shall, at a minimum: finished product shall be identified. (1) List the food safety hazards iden- (3) Food safety hazards might be ex- tified in accordance with paragraph (a) pected to arise from the following: of this section, which must be con- (i) Natural toxins; trolled for each process. (ii) Microbiological contamination; (2) List the critical control points for (iii) Chemical contamination; each of the identified food safety haz- (iv) Pesticides; ards, including, as appropriate: (v) Drug residues; (i) Critical control points designed to (vi) Zoonotic diseases; control food safety hazards that could (vii) Decomposition; be introduced in the establishment, (viii) Parasites; and (ix) Unapproved use of direct or indi- (ii) Critical control points designed rect food or color additives; and to control food safety hazards intro- (x) Physical hazards. duced outside the establishment, in- (b) The HACCP plan. (1) Every estab- cluding food safety hazards that occur lishment shall develop and implement before, during, and after entry into the a written HACCP plan covering each establishment; product produced by that establishment whenever a hazard analysis re- (3) List the critical limits that must veals one or more food safety hazards be met at each of the critical control that are reasonably likely to occur, points. Critical limits shall, at a min- based on the hazard analysis conducted imum, be designed to ensure that appli- in accordance with paragraph (a) of cable targets or performance standards this section, including products in the established by FSIS, and any other re- following processing categories: quirement set forth in this chapter per- (i) Slaughter—all species. taining to the specific process or prod- (ii) Raw product—ground. uct, are met; (iii) Raw product—not ground. (4) List the procedures, and the fre- (iv) Thermally processed—commer- quency with which those procedures cially sterile. will be performed, that will be used to (v) Not heat treated—shelf stable. monitor each of the critical control (vi) Heat treated—shelf stable. points to ensure compliance with the (vii) Fully cooked—not shelf stable. critical limits; (viii) Heat treated but not fully (5) Include all corrective actions that cooked—not shelf stable. have been developed in accordance (ix) Product with secondary inhibi- with § 417.3(a) of this part, to be fol- tors—not shelf stable. lowed in response to any deviation (2) A single HACCP plan may encom- from a critical limit at a critical con- pass multiple products within a single trol point; and processing category identified in this (6) Provide for a recordkeeping sys- paragraph, if the food safety hazards, tem that documents the monitoring of critical control points, critical limits, the critical control points. The records and procedures required to be identi- shall contain the actual values and ob- fied and performed in paragraph (c) of servations obtained during monitoring. this section are essentially the same, (7) List the verification procedures, provided that any required features of and the frequency with which those the plan that are unique to a specific procedures will be performed, that the product are clearly delineated in the establishment will use in accordance plan and are observed in practice. with § 417.4 of this part. (3) HACCP plans for thermally proc- (d) Signing and dating the HACCP essed/commercially sterile products do plan. (1) The HACCP plan shall be not have to address the food safety haz- signed and dated by the responsible es- ards associated with microbiological tablishment individual. This signature

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shall signify that the establishment ac- or other unforeseen hazard should be cepts and will implement the HACCP incorporated into the HACCP plan. plan. (c) All corrective actions taken in ac- (2) The HACCP plan shall be dated cordance with this section shall be doc- and signed: umented in records that are subject to (i) Upon initial acceptance; verification in accordance with (ii) Upon any modification; and § 417.4(a)(2)(iii) and the recordkeeping (iii) At least annually, upon reassess- requirements of § 417.5 of this part. ment, as required under § 417.4(a)(3) of this part. § 417.4 Validation, Verification, Reas- (e) Pursuant to 21 U.S.C. 456, 463, 608, sessment. and 621, the failure of an establishment (a) Every establishment shall vali- to develop and implement a HACCP date the HACCP plan’s adequacy in plan that complies with this section, or controlling the food safety hazards to operate in accordance with the re- identified during the hazard analysis, quirements of this part, may render and shall verify that the plan is being the products produced under those con- effectively implemented. ditions adulterated. (1) Initial validation. Upon completion [61 FR 38868, July 25, 1996, as amended at 62 of the hazard analysis and development FR 61009, Nov. 14, 1997] of the HACCP plan, the establishment shall conduct activities designed to de- § 417.3 Corrective actions. termine that the HACCP plan is func- (a) The written HACCP plan shall tioning as intended. During this identify the corrective action to be fol- HACCP plan validation period, the es- lowed in response to a deviation from a tablishment shall repeatedly test the critical limit. The HACCP plan shall adequacy of the CCP’s, critical limits, describe the corrective action to be monitoring and recordkeeping proce- taken, and assign responsibility for dures, and corrective actions set forth taking corrective action, to ensure: in the HACCP plan. Validation also en- (1) The cause of the deviation is iden- compasses reviews of the records them- tified and eliminated; selves, routinely generated by the (2) The CCP will be under control HACCP system, in the context of other after the corrective action is taken; validation activities. (3) Measures to prevent recurrence (2) Ongoing verification activities. On- are established; and going verification activities include, (4) No product that is injurious to but are not limited to: health or otherwise adulterated as a re- (i) The calibration of process-moni- sult of the deviation enters commerce. toring instruments; (b) If a deviation not covered by a (ii) Direct observations of monitoring specified corrective action occurs, or if activities and corrective actions; and another unforeseen hazard arises, the (iii) The review of records generated establishment shall: and maintained in accordance with (1) Segregate and hold the affected § 417.5(a)(3) of this part. product, at least until the require- (3) Reassessment of the HACCP plan. ments of paragraphs (b)(2) and (b)(3) of Every establishment shall reassess the this section are met; adequacy of the HACCP plan at least (2) Perform a review to determine the annually and whenever any changes acceptability of the affected product occur that could affect the hazard anal- for distribution; ysis or alter the HACCP plan. Such (3) Take action, when necessary, with changes may include, but are not lim- respect to the affected product to en- ited to, changes in: raw materials or sure that no product that is injurious source of raw materials; product for- to health or otherwise adulterated, as a mulation; slaughter or processing result of the deviation, enters com- methods or systems; production vol- merce; ume; personnel; packaging; finished (4) Perform or obtain reassessment product distribution systems; or, the by an individual trained in accordance intended use or consumers of the fin- with § 417.7 of this part, to determine ished product. The reassessment shall whether the newly identified deviation be performed by an individual trained

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in accordance with § 417.7 of this part. (c) Prior to shipping product, the es- The HACCP plan shall be modified im- tablishment shall review the records mediately whenever a reassessment re- associated with the production of that veals that the plan no longer meets the product, documented in accordance requirements of § 417.2(c) of this part. with this section, to ensure complete- (b) Reassessment of the hazard anal- ness, including the determination that ysis. Any establishment that does not all critical limits were met and, if ap- have a HACCP plan because a hazard propriate, corrective actions were analysis has revealed no food safety taken, including the proper disposition hazards that are reasonably likely to of product. Where practicable, this re- occur shall reassess the adequacy of view shall be conducted, dated, and the hazard analysis whenever a change signed by an individual who did not occurs that could reasonably affect produce the record(s), preferably by whether a food safety hazard exists. someone trained in accordance with Such changes may include, but are not § 417.7 of this part, or the responsible limited to, changes in: raw materials establishment official. or source of raw materials; product for- (d) Records maintained on computers. mulation; slaughter or processing The use of records maintained on com- methods or systems; production vol- puters is acceptable, provided that ap- ume; packaging; finished product dis- propriate controls are implemented to tribution systems; or, the intended use ensure the integrity of the electronic or consumers of the finished product. data and signatures. (e) Record retention. (1) Establish- § 417.5 Records. ments shall retain all records required (a) The establishment shall maintain by paragraph (a)(3) of this section as the following records documenting the follows: for slaughter activities for at establishment’s HACCP plan: least one year; for refrigerated product, (1) The written hazard analysis pre- for at least one year; for frozen, prescribed in § 417.2(a) of this part, includ- served, or shelf-stable products, for at ing all supporting documentation; least two years. (2) The written HACCP plan, includ- (2) Off-site storage of records re- ing decisionmaking documents associ- quired by paragraph (a)(3) of this sec- ated with the selection and develop- tion is permitted after six months, if ment of CCP’s and critical limits, and such records can be retrieved and pro- documents supporting both the moni- vided, on-site, within 24 hours of an toring and verification procedures se- FSIS employee’s request. lected and the frequency of those pro- (f) Official review. All records required cedures. by this part and all plans and proce- (3) Records documenting the moni- dures required by this part shall be toring of CCP’s and their critical lim- available for official review and copy- its, including the recording of actual ing. times, temperatures, or other quantifi- able values, as prescribed in the estab- § 417.6 Inadequate HACCP Systems. lishment’s HACCP plan; the calibration A HACCP system may be found to be of process-monitoring instruments; inadequate if: corrective actions, including all ac- (a) The HACCP plan in operation tions taken in response to a deviation; does not meet the requirements set verification procedures and results; forth in this part; product code(s), product name or iden- (b) Establishment personnel are not tity, or slaughter production lot. Each performing tasks specified in the of these records shall include the date HACCP plan; the record was made. (c) The establishment fails to take (b) Each entry on a record main- corrective actions, as required by § 417.3 tained under the HACCP plan shall be of this part; made at the time the specific event oc- (d) HACCP records are not being curs and include the date and time re- maintained as required in § 417.5 of this corded, and shall be signed or initialed part; or by the establishment employee making (e) Adulterated product is produced the entry. or shipped.

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§ 417.7 Training. Subpart C—Food Ingredients and Sources of Radiation (a) Only an individual who has met the requirements of paragraph (b) of 424.21 Use of food ingredients and sources of this section, but who need not be an radiation. employee of the establishment, shall be 424.22 Certain other permitted uses. permitted to perform the following 424.23 Prohibited uses. functions: AUTHORITY: 7 U.S.C. 450, 1901–1906; 21 U.S.C. (1) Development of the HACCP plan, 451–470, 601–695; 7 CFR 2.18, 2.53. in accordance with § 417.2(b) of this SOURCE: 64 FR 72175, Dec. 23, 1999, unless part, which could include adapting a otherwise noted. generic model that is appropriate for the specific product; and Subpart A—General (2) Reassessment and modification of the HACCP plan, in accordance with § 424.1 Purpose and scope. § 417.3 of this part. This part of the regulations pre- (b) The individual performing the scribes rules for the preparation of functions listed in paragraph (a) of this meat and the processing of poultry section shall have successfully com- products. The rules in this part further pleted a course of instruction in the ap- the purposes of the Federal Meat In- plication of the seven HACCP prin- spection Act (FMIA) and the Poultry ciples to meat or poultry product proc- Products Inspection Act (PPIA) by, essing, including a segment on the de- among other things, preventing the velopment of a HACCP plan for a spe- adulteration or misbranding of meat cific product and on record review. and poultry products at official establishments. 9 CFR Chapter III, Sub- § 417.8 Agency verification. chapter A, Parts 318 and 319, Subpart C of this part, and 21 CFR Chapter I, Sub- FSIS will verify the adequacy of the chapter A or Subchapter B, specify HACCP plan(s) by determining that rules for the use of certain food ingre- each HACCP plan meets the require- dients (e.g., food additives and color ments of this part and all other appli- additives) and sources of radiation that cable regulations. Such verification may render meat or poultry products may include: adulterated or misbranded. (a) Reviewing the HACCP plan; (b) Reviewing the CCP records; Subpart C—Food Ingredients and (c) Reviewing and determining the Sources of Radiation adequacy of corrective actions taken when a deviation occurs; § 424.21 Use of food ingredients and (d) Reviewing the critical limits; sources of radiation. (e) Reviewing other records per- (a)(1) General. No meat or poultry taining to the HACCP plan or system; product shall bear or contain any food (f) Direct observation or measure- ingredient that would render it adul- ment at a CCP; terated or misbranded, or which is not (g) Sample collection and analysis to approved in this part, part 318 or part determine the product meets all safety 319 of this chapter, or by the Adminis- standards; and trator in specific cases. (h) On-site observations and record (2)(i) Poultry products and poultry review. broth used in the processing of poultry products shall have been processed in the United States only in an official es- PART 424—PREPARATION AND tablishment or imported from a foreign PROCESSING OPERATIONS country listed in § 381.196(b), and have been inspected and passed in accord- Subpart A—General ance with the regulations. Detached Sec. ova and offal shall not be used in the 424.1 Purpose and scope. processing of any poultry products, except that poultry feet may be processed

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for use as human food in a manner ap- products in 21 CFR chapter I, sub- proved by the Administrator in specific chapter A or subchapter B, shall be cases and detached ova may be used in listed for such use under this chapter, the processing of poultry products if subject to declaration requirements in the processor demonstrates that such parts 316 and 317, or subparts M and N, ova comply with the requirements of of part 381 of this chapter, unless pre- the Federal Food, Drug, and Cosmetic cluded from such use or further re- Act. stricted in parts 318 or 319, or subparts (ii) Liquid, frozen, and dried egg O and P, of part 381 of this chapter, or products used in the processing of any unless such use otherwise results in the poultry product shall have been pre- adulteration or misbranding of meat or pared under inspection and be so poultry products. Food ingredients and marked in accordance with the Egg sources of radiation listed or approved Products Inspection Act. for use in the production of meat or (3)(i) Carcasses, parts thereof, and poultry products in 21 CFR Chapter I, products of cattle, sheep, swine, goats, subchapter A or subchapter B, may be or equines may be used in the proc- listed or approved for such use under essing of poultry products only if they this chapter by the Administrator in were prepared in the United States in § 424.21, subject to declaration require- an official meat packing establishment ments in parts 316 and 317, or subparts or imported from a foreign country M and N, of part 381 of this chapter. listed in § 327.2(b), were inspected and (2) No food ingredients or sources of passed in accordance with the Federal radiation may be used in the prepara- Meat Inspection Act and the regulation of any meat or poultry product, tions under such Act (subchapter A of for any purpose, unless the use is listed this chapter), and are so marked. or approved in 21 CFR chapter I as a di- (ii) Pork from carcasses or carcass rect food additive (21 CFR part 172), a parts used as an ingredient in poultry secondary direct food additive (21 CFR products that has been found free of part 173), indirect food additive (21 CFR trichinae, as described under § 318.10 parts 174–178), radiation source (21 CFR (a)(2), (e) and (f) of the Federal meat part 179), an interim-listed direct food inspection regulations (9 CFR 318.10 additive (21 CFR part 180), a prior-sanc- (a)(2), (e) and (f)), is not required to be tioned substance (21 CFR part 181), a treated for the destruction of Generally Recognized As Safe (GRAS) trichinae. substance (21 CFR parts 182 or 184), or (iii) Poultry products containing by a regulation in this chapter. Part pork muscle tissue which the Adminis- 319 of this chapter also specifies other trator determines at the time the la- food ingredients that are acceptable in beling for the product is submitted for preparing specified products. approval in accordance with part 381 of (3) No food ingredient, the intended the regulations in subchapter A or use of which is to impart color in any upon subsequent reevaluation of the meat or poultry product, shall be used product would be prepared in such a unless such use is approved in 21 CFR manner that the product might be chapter I as a color additive (21 CFR eaten rare or without thorough cook- parts 73, 74, 81, and 82) or in a regula- ing because of the appearance of the tion in this chapter. finished product or otherwise, shall be (4) Petitions to amend 21 CFR chap- effectively heated, refrigerated, or ter I to provide for uses of food addi- cured to destroy any possible live tives, or other substances or sources of trichinae, as prescribed in § 318.10(c) of radiation necessary in the preparation this chapter, at the official establish- of meat or poultry products, or food in- ment where such products are pre- gredients used to impart color to prod- pared. In lieu of such treatment of uct, should be sent to the Food and poultry products containing pork, the Drug Administration, in accordance pork ingredient may be so treated. with the provisions of 21 CFR parts 71 (b)(1) Food ingredients and sources of or 171, as appropriate. radiation. Food ingredients and sources (5) Inquiries concerning the regu- of radiation listed or approved for use latory status under the Federal Food, in the production of meat or poultry Drug, and Cosmetic Act of any articles

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intended for use as components of, or Development and Evaluation, Wash- in contact with, meat or poultry prod- ington, DC 20250–3700. ucts, may be addressed to the Food and (c) The food ingredients specified in Drug Administration, Center for Food the following chart are approved for Safety and Applied Nutrition, 200 C use in the preparation of meat prod- Street, SW, Washington, DC 20204, or ucts, provided they are used for the the Department of Agriculture, Food purposes indicated, within the limit of Safety and Inspection Service, Office of the amounts stated, and under other Policy, Program Development and conditions specified in this part and Evaluation, Washington, DC 20250–3700. part 317 of this chapter. Part 319 of this (6) Inquiries concerning the use in chapter specifies other food ingredients specific meat or poultry products of that are acceptable in preparing speci- substances that are not affirmed by the fied meat products. This chart also Food and Drug Administration as Gen- contains food ingredients that are ac- erally Recognized as Safe (GRAS) or ceptable for use in poultry products, otherwise listed in 21 CFR part 182 or provided they are used for the purpose part 184, or of food or color additives indicated, within the limits of the listed in 21 CFR regulations for general amounts stated and under other condi- use in foods or for use in meat, or poul- tions specified in this part. No meat or try products, generally, including mix- poultry product shall bear or contain tures of such substances or additives, any food ingredient that would render should be addressed to the Department it adulterated or misbranded, or which of Agriculture, Food Safety and Inspec- is not approved in this part, or by the tion Service, Office of Policy, Program Administrator in specific cases.

Class of substance Substance Purpose Products Amount

Acidifiers ...... Acetic acid ...... To adjust acidity ..... Various meat and poultry Sufficient for purpose. 3 products 2. Citric acid ...... do ...... do ...... Do. Glucono delta-lac- ...... do ...... do ...... Do. tone. Lactic acid ...... do ...... do ...... Do. Phosphoric acid ...... do ...... do ...... Do. Tartaric acid ...... do ...... do ...... Do. Anti-coagulants ...... Citric acid ...... To prevent clotting .. Fresh blood of livestock ...... 0.2 percent with or without water. When water is used to make a solution of citric acid added to the blood of livestock, not more than 2 parts of water to 1 part of citric acid shall be used. Sodium citrate ...... do ...... do ...... Not to exceed 0.5 percent based on the ingoing weight of the product. When water is used to make a solution of sodium citrate added to livestock blood, not more than 2 parts of water to 1 part of sodium citrate shall be used. Antifoaming agent .... Methyl polysilicone To retard foaming ... Soups (meat and poultry) ... 10 ppm...... do ...... Rendered fats (meat and Do. poultry)...... do ...... Curing pickle (meat and 50 ppm. poultry). Antimicrobial Agents Potassium lactate ... To inhibit microbial Various meat and poultry 4.8% by weight of total for- growth. products, except infant mulation. formulas and infant food. Sodium diacetate ...... do ...... do ...... 0.25% by weight of total formulation. Sodium lactate ...... do ...... do ...... 4.8% by weight of total formulation.

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Class of substance Substance Purpose Products Amount

Trisodium phos- To reduce microbial Raw, chilled poultry car- 8 to 12 percent; solution to phate. levels. casses. be maintained at 45 °F. to 55 °F. and applied by spraying or dipping carcasses for up to 15 seconds when used in accordance with 21 CFR 182.1778. Antioxidants and oxy- Ascorbyl palmitate .. To retard rancidity .. Margarine or oleomargarine 0.02 percent (by wt. of fin- gen interceptors. ished product) individually or in combination with other antioxidants approved for use in margarine. Ascorbyl stearate. BHA (butylated hydroxyanisole)...... do ...... Dry sausage ...... 0.003 based on total weight 0.006 percent in combination with other antioxidants for use in meat...... do ...... Rendered animal fat 0.01 percent ...... 0.02 percent in combination or a combination with other anti-oxidants of such fat and for use in meat. vegetable fat...... do ...... Fresh pork, sau- 0.01 percent based on fat 0.02 percent in combination sage, brown and content. with other anti-oxidants serve sausages, for use in meat, based on fresh Italian sau- fat content. sage products, pregrilled beef patties, fresh sausage made from beef or beef and pork, cooked or raw pizza topping and cooked or raw meatballs...... do ...... Dried meats ...... 0.01 percent based on total 0.01 percent in combination weight. with other anti-oxidants for use in meat...... do ...... Margarine or oleo- 0.02 percent (by wt. of the margarine. finished product) individually or in combination with other antioxidants approved for use in margarine...... do ...... Various poultry 0.01 percent based on fat products. content (0.02 percent in combination with any other antioxidant for use in poultry) based on fat content.. BHT (butylated hy- ...... do ...... Dry sausage ...... 0.003 percent based on droxytoluene). total weight 0.006 percent in combination with other anti-oxidants for use in meat...... do ...... Rendered animal fat 0.01 percent ...... 0.02 percent in combination or a combination with other anti-oxidants of such fat and for use in meat. vegetable fat.

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Class of substance Substance Purpose Products Amount

...... do ...... Fresh pork, sau- 0.01 percent based on fat 0.02 percent in combination sage, brown and content. with other anti-oxidants serve sausages, for use in meat, based on fresh Italian sau- fat content. sage products, pregrilled beef patties, fresh sausage made from beef or beef and pork, cooked or raw pizza topping and cooked or raw meatballs...... do ...... Dried meats ...... 0.01 percent based on total 0.01 percent in combination weight. with other anti-oxidants for use in meat...... do ...... Margarine or oleo- 0.02 percent (by wt. of the margarine. finished product) individually or in combination with other antioxidants approved for use in margarine...... do ...... Various poultry 0.01 percent based on fat products. content (0.02 percent in combination with any other antioxidant for use in poultry) based on fat content.. Dodecyl gallate ...... do ...... Margarine or oleomargarine 0.02 percent (by wt. of the finished product) individually or in combination with other antioxidants approved for use in margarine. Glycine ...... do ...... Rendered animal fat or a 0.01 percent 0.02 percent in combination of such fat combination with other and vegetable fat. anti-oxidants for use in meat. Octyl gallate ...... do ...... Margarine or oleomargarine 0.02 percent (by wt. of the finished product) individually or in combination with other antioxidants approved for use in margarine. Propyl gallate ...... do ...... Dry sausage ...... 0.003 percent based on total weight 0.006 percent in combination with other anti-oxidants for use in meat...... do ...... Rendered animal fat 0.01 percent ...... 0.02 percent in combination or a combination with other anti-oxidants of such fat and for use in meat. vegetable fat...... do ...... Fresh pork, sau- 0.01 percent based on fat 0.02 percent in combination sage, brown and content. with other anti-oxidants serve sausages, for use in meat, based on fresh Italian sau- fat content. sage products, pregrilled beef patties, fresh sausage made from beef or beef and pork, cooked or raw pizza topping and cooked or raw meatballs...... do ...... Dried meats ...... 0.01 percent based on total 0.01 percent in combination weight. with other anti-oxidants for use in meat.

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Class of substance Substance Purpose Products Amount

...... do ...... Margarine or oleo- 0.02 percent (by wt. of the margarine. finished product) individually or in combination with other antioxidants approved for use in margarine...... do ...... Various poultry 0.01 percent based on fat products. content (0.02 percent in combination with any other antioxidant for use in poultry, except TBHQ, based on fat content).. Resin guaiac ...... do ...... Rendered animal fat or a 0.02 percent in combination combination of such fat with other antioxidants for and vegetable fat 0.01 use in meat. percent. TBHQ (tertiary ...... do ...... Dry sausage 0.003 percent 0.006 percent in combina- butylhydroquinon- based on weight. tion only with BHA and/or e). BHT...... do ...... Rendered animal fat 0.01 percent ...... 0.02 percent in combina- or a combination tion only with BHA or of such fat and BHT. vegetable fat...... do ...... Fresh pork, sau- 0.01 percent based on fat 0.02 percent in combin- sage, brown and content. ation only with BHA and/ serve sausages, or BHT, based on fat con- fresh Italian sau- tent. sage products, pregrilled beef patties, fresh sausage made from beef or beef and pork, cooked or raw pizza topping and cooked or raw meatballs...... do ...... Dried meats ...... 0.01 percent based on total 0.01 percent in combina- weight. tion only with BHA and/or BHT...... do ...... Margarine or oleo-mar- 0.02 percent alone or in garine. combination only with BHA and/or BHT, based on oil or fat content...... do ...... Various poultry products ..... 0.01 percent based on fat content (0.02 percent in combination only with BHA and/or BHT, based on fat content). Tocopherols ...... do ...... Rendered animal fat or a 0.03 percent. A 30 percent combination of such fat concentration of and vegetable fat. tocopherols in vegetable oils shall be used when added as an antioxidant to products designated as ‘‘lard’’ or ‘‘rendered pork fat.’’ ...... do ...... Dry sausage, semidry sau- Not to exceed 0.03 percent sage, dried meats, based on fat content. Not uncooked or cooked fresh used in combination with sausage made with beef other antioxidants. and/or pork, uncooked or cooked Italian sausage products, uncooked or cooked meatballs, uncooked or cooked meat pizza toppings, brown and serve sausages, pregrilled beef patties, and restructured meats.

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Class of substance Substance Purpose Products Amount

...... do ...... Various poultry products ..... 0.03 percent based on fat content (0.02 percent in combination with any other antioxidant for use in poultry, except TBHQ, based on fat content). Artificial Sweeteners Saccharin ...... To sweeten product Bacon ...... 0.01 percent. Binders and Extend- Agar-agar ...... To stabilize and Thermally processed 0.25 percent of finished ers. thicken. canned and jellied meat product. food products. Algin ...... To extend and sta- Breading mix; sauces (meat Sufficient for purpose in ac- bilize product. only) and various poultry cordance with 21 CFR products. 172.5. A mixture of sodium To bind meat pieces Restructured meat food Sodium alginate not to ex- alginate, calcium products. ceed 1.0 percent; calcium carbonate and carbonate not to exceed calcium lactate/ 0.2 percent; and lactic lactic acid (or acid/calcium lactate (or glucono delta lac- glucono delta-lactone) not tone). to exceed 0.3 percent of product formulation. Added mixture may not exceed 1.5 percent of product at formulation. Mixture ingredients must be added dry. A mixture of sodium To bind poultry Ground and formed raw or Sodium alginate not more alginate, calcium pieces. cooked poultry pieces. than 0.8 percent, calcium carbonate, lactic carbonate not more than acid, and calcium 0.15 percent; lactic acid lactate. and calcium lactate, in combination, not more than 0.6 percent of product formulation. Added mixture may not exceed 1.55 percent of product at formulation. The mixture must be added in dry form. Bread ...... To bind and extend Bockwurst ...... 3.5 percent individually or product. collectively with other binders for use in meat...... do ...... Chili con carne, chili con 8 percent individually or col- carne with beans. lectively with other binders for use in meat...... do ...... Spaghetti with meat balls 12 percent individually or and sauce, spaghetti with collectively with other meat and sauce and simi- binders for use in meat. lar products. Carboxymethyl cel- To extend and sta- Baked pies (meat only) and Sufficient for purpose in ac- lulose (cellulose bilize product. various poultry products. cordance with 21 CFR gum). 172.5. Carrageenan ...... To extend and sta- Breading mix; sauces (meat Sufficient for purpose in ac- bilize product. only) and various poultry cordance with 21 CFR products. 172.5. To prevent purging Cured pork products as pro- Not to exceed 1.5 percent of brine solution. vided in 9 CFR of product formulation; 319.104(d). permitted in combination only with soy protein concentrate, combination not to exceed 1.5 percent of product formulation; in accordance with 21 CFR 172.620, 172.623, and 172.626.

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Class of substance Substance Purpose Products Amount

Carrageenan, Lo- ...... do ...... do ...... In combination, not to ex- cust bean gum, ceed 0.5 percent of for- and Xanthan gum mulation; not permitted in blend. combination with other binders approved for use in cured pork products; in accordance with 21 CFR 172.620, 172.623, 172.626, 184.1343, and 172.695. Cereal ...... To bind and extend Sausages as provided in 9 3.5 percent individually or product. CFR Part 319, bockwurst. collectively with other binders for use in meat...... do ...... Chili con carne, chili con 8 percent individually or col- carne with beans. lectively with other binders for use in meat. Dried milk ...... do ...... Sausages as provided for in 3.5 percent individually or 9 CFR Part 319. collectively with other binders for use in meat Dried skim milk, cal- ...... do ...... Sausages as provided in 9 Do. cium reduced. CFR 9 CFR Part 319...... do ...... Chili con carne, chili con 8 percent individually or col- carne with beans. lectively with other binders for use in meat. Enzyme (rennet) ...... do ...... Sausages as provided for in 3.5 percent total finished treated with cal- 9 CFR Part 319. product (calcium lactate cium reduced required at rate of 10 per- dried skim milk cent of binder.) and calcium lactate...... do ...... Imitation sausages; nonspe- Sufficient for purpose in ac- cific loaves; soups, stews cordance with 21 CFR (meat only) and various 172.5 (calcium lactate re- poultry products. quired at a rate of 10 percent of binder). Enzyme (rennet) ...... do ...... Imitation sausages; nonspe- Sufficient for purpose in ac- treated with so- cific loaves; soups, stews cordance with 21 CFR dium caseinate (meat only) and various 172.5 (calcium lactate re- and calcium lac- poultry products. quired at a rate of 25 per- tate. cent of binder). Food starch modi- To prevent purging Cured pork products as pro- Not to exceed 2 percent of fied. of brine solution. vided for in 9 CFR product formulation in 319.104(d). ‘‘Ham Water Added’’ and ‘‘Ham with Natural Juices’’ products; not to exceed 3.5 percent of product formulation in ‘‘Ham and Water Prod- uct—X percent of Weight is Added Ingredients’’ products; permitted in combination only with soy protein concentrate, with combination of modified food starch at 3 percent of product formulation and soy protein concentrate at 0.5 percent of product formulation; in accordance with 21 CFR 172.892. Gelatin ...... To bind and extend Various poultry products ..... Sufficient for purpose in ac- product. cordance with 21 CFR 172.5. Gums, vegetable ...... do ...... Egg roll (meat only) and Sufficient for purpose in ac- various poultry products. cordance with 21 CFR 172.5. Isolated soy protein ...... do ...... Sausage as provided for in 2 percent. 9 CFR Part 319, bockwurst.

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Class of substance Substance Purpose Products Amount

...... do ...... Imitation sausages; nonspe- Sufficient for purpose in ac- cific loaves; soups; stews cordance with 21 CFR (meat only) and various 172.5. poultry products...... do ...... Chili con carne, chili con 8 percent individually or col- carne with beans. lectively with other binders for use in meat...... do ...... Spaghetti with meatballs 12 percent individually or and sauce, spaghetti with collectively with other meat and sauce and simi- binders and extenders for lar products. use in meat. To prevent purging Cured pork products as pro- Not to exceed 2 percent of of brine solution. vided for in 9 CFR product formulation, not 319.104(d). permitted in combination with other binders approved for use in cured pork products. Methyl cellulose ...... To extend and sta- Meat and vegetable patties; 0.15 percent. bilize product various poultry products. (also carrier). Sodium caseinate ... To bind and extend Imitation sausages, nonspe- Sufficient for purpose in ac- product. cific loaves, soups, stews cordance with 21 CFR (meat only). 182.1748 and 21 CFR 172.5...... do ...... Sausages as provided for in 2 percent in accordance 9 CFR Part 319. with 21 CFR 182.1748...... do ...... Chili con carne, chili con 8 percent individually or col- carne with beans. lectively with other binders and extenders for use in meat in accordance with 21 CFR 182.1748...... do ...... Spaghetti with meatballs 12 percent individually or and sauce, spaghetti with collectively with other meat and sauce and simi- binders and extenders for lar products. use in meat in accordance with 21 CFR 182.1748. To prevent purging Cured pork products as pro- Not to exceed 2 percent of of brine solution. vided for in 9 CFR product formulation; not 319.104(d). permitted in combination with other binders approved for use in cured pork products, in accordance with 21 CFR 182.1748. To bind and extend Various poultry products ..... 3 percent in cooked prod- product. uct, 2 percent in raw product, in accordance with 21 CFR 172.5 and 182.1748. Soy flour ...... do ...... Sausages as provided for in 3.5 percent individually or 9 CFR Part 319, collectively with other bockwurst. binders and extenders for use in meat...... do ...... Chili con carne, chili con 8 percent individually or col- carne with beans. lectively with other binders and extenders for use in meat...... do ...... Spaghetti with meatballs 12 percent individually or and sauce, spaghetti with collectively with other meat and sauce and simi- binders and extenders for lar products. use in meat. Soy protein con- ...... do ...... Sausage as provided for in 3.5 percent individually or centrate. 9 CFR Part 319, collectively with other bockwurst. binders and extenders for use in meat...... do ...... Chili con carne, chili con 8 percent individually or col- carne with beans. lectively with other binders and extenders for use in meat...... do ...... Spaghetti with meatballs 12 percent individually or and sauce, spaghetti with collectively with other meat and sauce and simi- binders and extenders for lar products. use in meat.

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Class of substance Substance Purpose Products Amount

To prevent purging Cured pork products as pro- Not to exceed 3.5 percent of brine solution. vided for in 9 CFR of product formulation; 319.104(d). permitted in combination only with modified food starch, with combination of modified food starch at 3 percent of product formulation and soy protein concentrate at 0.5 percent of product formulation; in combination only with carrageenan, combination not to exceed 1.5 percent of product formulation. Starchy vegetable To bind and extend Sausage as provided for in 3.5 percent individually or flour. product. 9 CFR Part 319, collectively with other bockwurst. binders and extenders for use in meat...... do ...... Chili con carne, chili con 8 percent individually or col- carne with beans. lectively with other binders and extenders for use in meat. Tapioca dextrin ...... do ...... Sausage as provided for in 3.5 percent individually or 9 CFR Part 319, collectively with other bockwurst. binders and extenders for use in meat, in accordance with 21 CFR 184.1277...... do ...... Chili con carne, chili con 8 percent individually or col- carne with beans. lectively with other binders and extenders for use in meat, in accordance with 21 CFR 184.1277...... do ...... Spaghetti with meatballs 12 individually or collectively and sauce, spaghetti with with other binders and ex- meat and sauce and simi- tenders for use in meat, lar products. in accordance with 21 CFR 184.1277...... do ...... Various poultry products ..... Sufficient for purpose in accordance with 21 CFR 184.1277. Vegetable starch ...... do ...... Sausage as provided for in 3.5 percent individually or 9 CFR Part 319, collectively with other bockwurst. binders and extenders for use in meat...... do ...... Chili con carne, chili con 8 percent individually or col- carne with beans. lectively with other binders and extenders for use in meat. Wheat gluten ...... To bind and extend Sausage as provided for in 3.5 percent individually or product. 9 CFR Part 319, collectively with other bockwurst. binders and extenders for use in meat, in accordance with 21 CFR 184.1322...... do ...... Chili con carne, chili con 8 percent individually or col- carne with beans. lectively with other binders for use in meat, in accordance with 21 CFR 184.1322...... do ...... Spaghetti with meatballs 12 percent individually or and sauce, spaghetti with collectively with other meat and sauce and simi- binders and extenders for lar products. use in meat, in accordance with 21 CFR 184.1322...... do ...... Various poultry products ..... Sufficient for purpose in accordance with 21 CFR 184.1322.

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Class of substance Substance Purpose Products Amount

Whey, Dry or dried To bind or thicken .. Sausage as provided for in 3.5 percent individually or 9 CFR Part 319, collectively with other bockwurst. binders and extenders for use in meat...... do ...... Imitation sausages, nonspe- 8 percent individually or col- cific loaves, soups, stews lectively with other bind- (meat only). ers and extenders for use in meat...... do ...... Chili con carne, chili con 8 percent individually or col- carne with beans, pork or lectively with other bind- beef with barbecue sauce. ers and extenders for use in meat...... do ...... Various poultry products ..... Sufficient for purpose in accordance with 21 CFR 184.1322. Whey, Reduced lac- To bind or thicken .. Sausage as provided for in 3.5 percent individually or tose. 9 CFR Part 319, collectively with other bockwurst. binders and extenders for use in meat...... do ...... Imitation sausages, nonspe- Sufficient for purpose in ac- cific loaves, soups, stews cordance with 21 CFR (meat only). 172.5...... do ...... Chili con carne, chili con 8 percent individually or col- carne with beans, pork or lectively with other bind- beef with barbecue sauce. ers and extenders for use in meat. Whey, Reduced ...... do ...... Sausage as provided for in 3.5 percent individually or minerals. 9 CFR Part 319, collectively with other bockwurst. binders and extenders for use in meat...... do ...... Imitation sausages, nonspe- Sufficient for purpose in ac- cific loaves, soups, stews cordance with 21 CFR (meat only). 172.5...... do ...... Chili con carne, chili con 8 percent individually or col- carne with beans, pork or lectively with other bind- beef with barbecue sauce. ers and extenders for use in meat. Whey protein con- ...... do ...... Sausage as provided in 9 3.5 percent individually or centrate. CFR Part 319, bockwurst. collectively with other binders and extenders for use in meat, in accordance with 21 CFR 184.1979c...... do ...... Imitation sausages, nonspe- Sufficient for purpose in ac- cific loaves, soups, stews. cordance with 21 CFR 184.1979c...... do ...... Chili con carne, chili con 8 percent individually or col- carne with beans, pork or lectively with other bind- beef with barbecue sauce. ers and extenders for use in meat, in accordance with 21 CFR 184.1979c To bind meat pieces Restructured meat food 3.5 percent individually or products, whole muscle collectively with other meat cuts. binders and extenders for use in meat, in accordance with 21 CFR 184.1979c. Xanthan gum ...... To maintain: uniform Meat sauces, gravies or Sufficient for purpose in ac- viscosity; suspen- sauces and meats, cordance with 21 CFR sion of particulate canned or frozen and/or 172.5. matter, emulsion refrigerated meat salads, stability; freeze- canned or frozen meat thaw stability. stews, canned chili or chili with beans, pizza topping mixes and batter or breading mixes...... do ...... Various poultry products, Sufficient for purpose except uncooked products or sausages or other products with a moisture limitation established by Subpart P of Part 381.

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Class of substance Substance Purpose Products Amount

Bleaching Agent ...... Hydrogen peroxide To remove color ..... Tripe (substance must be Sufficient for purpose. removed from product by rinsing with clear water). Catalysts (sub- Nickel ...... To accelerate chem- Rendered animal fats or a Do. stances must be ical reaction. combination of such fats eliminated during and vegetable fats. process). Sodium amide ...... Rearrangement of ...... do ...... Do. fatty acid radicals. Sodium methoxide ...... do ...... do ...... Chilling Media ...... Salt (NaCl) ...... To aid in chilling ..... Raw poultry products ...... 700 lbs. to 10,000 gallons of water. Coloring Agents (arti- Coal tar dyes To color products ... Various poultry products ..... Sufficient for purpose. ficial). (FD&C certified). Color additives list- To color casings or Sausage casings, oleo- Sufficient for purpose (may ed in 21 CFR Part rendered fats; margarine, shortening, be mixed with approved 74, Subpart A of marking and marking or branding ink natural coloring matters Part 82, Subpart branding product. on product (meat only). or harmless inert material B (operator must such as common salt and furnish evidence sugar). to inspector in charge that color additive has been certified for use in connection with foods by the Food and Drug Admin- istration). Titanium oxide ...... To whiten ...... Canned ham salad spread 0.5 percent. and creamed-type canned meat products. Poultry salads and poultry spreads. Coloring Agents (nat- Alkanet, annatto, To color casings or Sausage casings, oleo- Sufficient for purpose (may ural). carotene, cochi- rendered fats; margarine, shortening, be mixed with approved neal, green chlo- marking and marking or branding ink artificial dyes or harmless rophyll, saffron branding product. on product (meat only). inert material such as and tumeric. common salt and sugar). Annatto, carotene ... To color products ... Various poultry products ..... Sufficient for purpose. Curing accelerators Ascorbic acid ...... To accelerate color Cured pork and beef cuts, 75 oz to 100 gal pickle at (must be used only fixing or preserve cured poultry, cured 10 percent pump level; 3⁄4 in combination with color during stor- comminuted poultry and oz to 100 lb meat, meat curing agents). age. meat food products. byproduct or poultry product; 10 percent solution to surfaces of cured meat cuts or poultry products prior to packaging. (The use of such solution shall not result in the addition of a significant amount of moisture to the product). Citric acid or sodium To accelerate color Cured pork and beef cuts, May be used in cured meat citrate. fixing or preserve cured comminuted meat products or in 10 percent color during stor- food product, cured solution used to spray age. comminuted poultry or surfaces of cured meat poultry products. cuts prior to packaging to replace up to 50 percent of the ascorbic acid, erythorbic acid, sodium ascorbate, or sodium erythorbate that is used. May be used in cured poultry products to replace 50 percent of the ascorbic acid or sodium ascorbate that is used.

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Class of substance Substance Purpose Products Amount

Erythorbic acid ...... To accelerate color Cured pork and beef cuts, 75 oz to 100 gal pickle at fixing or preserve cured poultry, cured 10 percent pump level; 3/ color during stor- comminuted poultry and 4 oz to 100 lb meat, meat age. meat food products. byproduct or poultry product; 10 percent solution to surfaces of cured meat cuts or poultry products prior to packaging. (The use of such solution shall not result in the addition of a significant amount of moisture to the product). Fumaric acid ...... do ...... Cured, comminuted meat, 0.065 percent (or 1 oz to poultry or meat and poul- 100 lb) of the weight of try products. the meat, poultry or the meat or poultry byproducts before processing. Glucono delta lac- ...... do ...... Cured, comminuted meat or 8 oz to each 100 lb of meat tone. meat food product. or meat byproduct...... do ...... Genoa salami ...... 16 oz to 100 lb of meat (1.0 percent). Sodium acid ...... do ...... Frankfurters, wieners, vi- Not to exceed alone or in pyrophosphate. enna, bologna, garlic bo- combination with other logna, knockwurst and curing accelerators for similar products. use in meat the following: 8 oz in 100 lb of meat, or meat and meat byproducts, content of the formula; nor 0.5 percent in the finished product. Sodium ascorbate .. To accelerate color Cured pork and beef cuts, 87.5 oz to 100 gal pickle at fixing or preserve cured comminuted meat 10 percent pump level; 7⁄8 color during stor- food product, cured oz to 100 lb meat, meat age. comminuted poultry or byproduct or poultry prod- poultry products. uct; 10 percent solution to surfaces of cured meat cuts or poultry products prior to packaging. (The use of such solution shall not result in the addition of a significant amount of moisture to the product). Sodium erythorbate To accelerate color Cured pork and beef cuts, 87.5 oz to 100 gal pickle at fixing or preserve cured comminuted meat 10 percent pump level; 7⁄8 color during stor- food products, cured oz to 100 lb meat, meat age. comminuted poultry or byproduct or poultry prod- poultry products. uct; 10 percent solution to surfaces of cured meat cuts or poultry products prior to packaging. (The use of such solution shall not result in the addition of a significant amount of moisture to the product.) Curing Agents ...... Sodium or potas- Source of nitrite ...... Cured meat products other 7 lb to 100 gal pickle; 31⁄2 sium nitrate. than bacon. Nitrates may oz to 100 lb meat or poul- not be used in baby, jun- try product (dry cure); 23⁄4 ior, and toddler foods. oz to 100 lb chopped Cured, comminuted poul- meat or poultry. try or poultry products.

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Class of substance Substance Purpose Products Amount

Sodium or potas- To fix color ...... Cured meat and poultry 2 lb to 100 gal pickle at 10 sium nitrite (sup- products. Nitrites may not percent pump level; 1 oz plies of sodium ni- be used in baby, junior, to 100 lb meat or poultry trite and potas- or toddler foods. product (dry cure); 1⁄4 oz sium nitrite and to 100 lb chopped meat, mixtures con- meat byproduct or poultry taining them must product. The use of be kept under the nitrites, nitrates or com- care of a respon- bination shall not result in sible employee of more than 200 ppm of ni- the establishment. trite, calculated as sodium The specific nitrite nitrite in finished product, content of such except that nitrites may supplies must be be used in bacon only in known and clearly accordance with para- marked accord- graph (b) of this section. ingly). Denuding Agents Lime (calcium oxide, To denude mucous Tripe ...... Sufficient for purpose. (may be used in calcium hydrox- membranes. combination. Must ide). be removed from tripe by rinsing with potable water.). Sodium carbonate ...... do ...... do ...... Do. Sodium citrate ...... do ...... do ...... Do. Sodium gluconate ...... do ...... do ...... Do. Sodium hydroxide ...... do ...... do ...... Do. Sodium persulfate ...... do ...... do ...... Do. Sodium silicates ...... do ...... do ...... Do. (ortho, meta, and sesqui). Trisodium phos- ...... do ...... do ...... Do. phate. Emulsifying Agents .. Actylated To emulsify product Shortening and various Sufficient for purpose. monoglycerides. poultry products. Diacetyl tartaric acid ...... do ...... do ...... Do. esters of mono- and diglycerides. Glycerol-lacto stea- ...... do ...... do ...... Do. rate, oleate, or palmitate. Lecithin ...... To emulsify product Oleomargarine, shortening, 0.5 percent in oleo- (also as an anti- various meat and poultry margarine, use in other oxidant). products. products—sufficient amount for emulsification. Mono and To emulsify product Rendered animal fat or a Sufficient for purpose in lard diglycerides (glyc- combination of such fat and shortening; 0.5 per- erol palmitate, with vegetable fat; oleo- cent in oleomargarine. etc.). margarine...... do ...... Various poultry products ..... Sufficient for purpose. Mono and ...... do ...... Margarine or oleomargarine 0.5 percent. diglycerides of fatty acids esterified with any of the following acids: acetic, acetyltartaric, citric, lactic, tartaric, and their sodium and calcium salts; the sodium sulfoacetate derivatives of these mono and diglycerides.

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Class of substance Substance Purpose Products Amount

Polyglycerol esters ...... do ...... Rendered animal fat or a Sufficient for purpose for of fatty acids combination of such fat rendered animal fat or (polyglycerol with vegetable fat when combination with vege- esters of fatty use is not precluded by table fat; 0.5 percent for acids are re- standards of identity of oleomargarine. stricted to those composition; oleo- up to and includ- margarine. ing the decaglycerol esters and otherwise meeting the requirements of § 172.854(a) of the Food Additive Regulations). Polysorbate 60 ...... do ...... Shortening for use in non- 1 percent when used alone. (polyoxyethylene standardized baked If used with polysorbate (20) sorbitan goods, baking mixes, 80 the combined total monostearate). icings, fillings, and top- shall not exceed 1 per- pings and in the frying of cent. foods (meat only). Ren- dered poultry fat or a combination of such fat with vegetable fat. Polysorbate 80 ...... do ...... Shortening for use in non- 1 percent when used alone. (polyoxyethylene standardized baked If used with polysorbate (20) sorbitan goods, baking mixes, 60 the combined total monooleate). icings, fillings, and top- shall not exceed 1 per- pings and in the frying of cent. foods (meat only). Var- ious poultry products. 1,2-propylene glycol ...... do ...... Margarine or oleomargarine 2.0 percent. esters of fatty acids. Propylene glycol ...... do ...... Rendered animal or poultry Sufficient for purpose. mono and fat or a combination of diesters of fats such fat with vegetable and fatty acids. fat. Stearyl-2-lactylic ...... do ...... Shortening to be used for 3.0 percent. acid. cake icings and fillings (meat only). Stearyl ...... do ...... Shortening ...... Sufficient for purpose monoglyceridyl citrate. Film Forming Agents A mixture consisting To reduce cooler Freshly dressed meat car- Formulation may not ex- of water, sodium shrinkage and casses. Such carcasses ceed 1.5 percent of hot alginate, calcium help protect sur- must bear a statement carcass weight when ap- chloride, sodium face. ‘‘Protected with a film of plied. Chilled weight may carboxymethyl- water, corn syrup solids, not exceed hot weight. cellulose, and sodium alginate, calcium corn syrup solids. chloride and sodium carboxymethyl-cellulose.’’. Flavoring Agents; Artificial smoke fla- To flavor product .... Various (meat and poultry) 2 Sufficient for purpose. Protectors and De- voring. velopers. Autolyzed yeast ex- ...... do ...... do ...... Do. tract. Benzoic acid (so- To retard flavor re- Margarine or oleomargarine 0.1 percent individually, or if dium, potassium version. used in combination with and calcium salts). other flavoring agents for use in meat or with sorbic acid and its salts, 0.2 percent (expressed as the acids in the wt. of the finished foods). Calcium lactate ...... To protect flavor ..... Cooked semi-dry and dry 0.6 percent in product for- products including sau- mulation. sage, imitation sausage, and nonspecific meat food sticks. Citric acid ...... do ...... Various poultry products ..... Sufficient for purpose. Flavoring ...... Chili con carne ...... Do.

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Class of substance Substance Purpose Products Amount

Corn syrup solids; To flavor product .... Various poultry products, Do. corn syrup; glu- sausage, hamburger, cose syrup. meat loaf, luncheon meat, chopped or pressed ham. Dextrose ...... do ...... Sausage, ham and cured Do. products. Diacetyl ...... do ...... Oleomargarine ...... Do. Disodium guanylate ...... do ...... Various meat and poultry products. 2 Disodium inosinate ...... do ...... do ...... Do. Harmless bacteria To develop flavor .... Dry sausage, pork roll, 0.5 percent. starters of the aci- thuringer, lebanon bolo- dophilus type, lac- gna, cervelat, and salami. tic acid starter or culture of Pediococcus cerevisiae. Harmless lactic acid To prevent the Bacon ...... Sufficient for purpose. producing bacteria. growth of Clos- tridium botulinum. Hydrolyzed plant To flavor product .... Various meat and poultry Do. protein. products. 2 Isopropyl citrate ...... To protect flavor ..... Oleomargarine ...... 0.02 percent. Malt syrup ...... To flavor product .... Cured meat products ...... 2.5 percent...... do ...... Various poultry products ..... Sufficient for purpose. Milk protein hydroly- ...... do ...... Various meat and poultry Do. sate. products. 2 Monoammonium ...... do ...... do ...... Do. glutamate. Monosodium glu- ...... do ...... do ...... Do. tamate. Potassium lactate ...... do ...... Various meat and meat Not to exceed 2 percent of food products, poultry and formulation; in accord- poultry food products, ex- ance with 21 CFR cept infant formula and 184.1639. infant food. 2 Smoke flavoring ...... To flavor product .... Various meat and poultry Sufficient for purpose. products. Sodium acetate ...... To flavor products .. Various meat and poultry Not to exceed 0.25% of for- products. mulate in accordance with 21 CFR 184.1721. Sodium diacetate ...... do ...... do ...... Not to exceed 0.25% of formulate in accordance with 21 CFR 184.1754. Sodium lactate ...... do ...... Various meat and meat Not to exceed 2 percent of food products, poultry and formulation in accordance poultry food products, ex- with 21 CFR 184.1768. cept infant formula and infant food. 2 Sodium sulfoacetate ...... do ...... Various meat and poultry 0.5 percent. derivative of mono products. 2 and diglycerids. Sodium To help protect fla- ‘‘Fresh Beef,’’ 2 ‘‘Beef for 0.5 percent of total product. tripolyphosphate. vor. further cooking, ‘‘Cooked Beef,’’ Beef Patties, Meat Loaves, Meat Toppings, and similar products derived from pork, lamb, veal, mutton, and goat meat which are cooked or frozen after processing. Sodium ...... do ...... do ...... Do. tripolyphosphate and sodium mixtures, metaphosphate, insoluble; and sodium polyphosphates, glassy.

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Class of substance Substance Purpose Products Amount

Sorbitol ...... To flavor, to facili- Cooked sausage labeled Not to exceed 2 percent of tate the removal frankfurter, frank, furter, the weight of the formula of casings from wiener, and knockwurst; excluding the formula product, and to cured pork and pork prod- weight of water or ice, reduce ucts, as provided for in 9 when used in accordance caramelization CFR Part 319. with 21 CFR 184.1835. and charring. Starter distillate ...... To help protect fla- Oleomargarine ...... Sufficient for purpose. vor. Stearyl citrate ...... do ...... do ...... 0.15 percent. Sugars (sucrose To flavor product .... Various meat and poultry Sufficient for purpose. and dextrose). products. Gases ...... Carbon dioxide liq- Contact freezing ..... Various poultry products ..... Do. uid. Carbon dioxide solid To cool product ...... Chopping of meat, packing Sufficient for purpose. (dry ice). of product. To cool product or Various poultry products ..... Do. facilitate chopping or packaging. Nitrogen ...... To exclude oxygen Various meat and poultry Do. from sealed con- products. tainers. Nitrogen, liquid ...... Contact freezant ...... do ...... Do. Hog Scald Agents Caustic soda ...... To remove hair ...... Hog carcasses ...... Sufficient for purpose. (must be removed by subsequent cleaning operations). Dicotyl sodium ...... do ...... do ...... Do. sulfosuccinate. Dimethylpolysiloxan- ...... do ...... do ...... Do. e. Disodium-calcium ...... do ...... do ...... Do. ethylenediaminet- etra-acetate. Disodium phosphate ...... do ...... do ...... Do. Ethylenediaminetetr- ...... do ...... do ...... Do. a-acetic acid (sodium salts). Lime (calcium oxide, ...... do ...... do ...... Do. calcium hydroxide). Potassium hydrox- Do. ide. Propylene glycol ...... do ...... do ...... Do. Soap (prepared by ...... do ...... do ...... Do. the reaction of calcium, potassium, or sodium with rosin or fatty acids of natural fats and oils). Sodium acid ...... do ...... do ...... Do. pyrophosphate. Sodium carbonate ...... do ...... do ...... Do. Sodium ...... do ...... do ...... Do. dodecylbenzene sulfonate. Sodium gluconate ...... do ...... do ...... Do. Sodium ...... do ...... do ...... Do. hexametaphosph- ate. Sodium lauryl sul- ...... do ...... do ...... Do. fate. Sodium mono and ...... do ...... do ...... Do. dimethylnaphthal- ene sulfonate (molecular weight 245–260).

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Class of substance Substance Purpose Products Amount

Sodium n- ...... do ...... do ...... Do. alkylbenzene sulfonate (alkyl group predomi- nantly C12 and C13 and not less than 95 percent C10 and C16). Sodium ...... do ...... do ...... Do. pyrophosphate. Sodium silicates ...... do ...... do ...... Do. (ortho, meta, and sesqui). Sodium sulfate ...... do ...... do ...... Do. Sodium ...... do ...... do ...... Do. tripolyphosphate. Sucrose ...... do ...... do ...... Do. Triethanolamine ...... do ...... do ...... Do. dodecylbenzene sulfonate. Trisodium phos- ...... do ...... do ...... Do. phate. Miscellaneous ...... Adipic acid ...... To acidify ...... Margarine or oleomargarine Sufficient for purpose. Ascorbic acid, To delay discolora- Fresh beef cuts, fresh lamb Not to exceed, singly or in erythorbic acid, tion. cuts, and fresh pork cuts. combination, 500 ppm or citric acid, sodium 1.8 mg/sq inch of product ascorbate and so- surface of ascorbic acid dium citrate, sin- (in accordance with 21 gly or in combina- CFR 182.3013), tion. erythorbic acid (in accordance with 21 CFR 182.3041), or sodium ascorbate (in accordance with 21 CFR 182.3731); and/or not to exceed, singly or in combination, 250 ppm or 0.9 mg/sq inch of product surface of citric acid (in accordance with 21 CFR 182.6033), or sodium citrate (in accordance with 21 CFR 182.6751). Calcium disodium, To preserve product Margarine or oleomargarine 75 ppm by weight of the fin- EDTA (calcium di- and to protect fla- ished oleomargarine or sodium ethylene- vor. margarine. diaminetetra- acetate. Calcium propionate To retard mold Pizza crust ...... 0.32 percent alone or in growth. combination based on weight of the flour brace used...... do ...... Fresh pie dough (poultry 0.3 percent of calcium pro- only). pionate or sodium propionate alone, or in combination, based on weight of flour used. Citric acid ...... To preserve cured Cured pork cuts ...... Not to exceed 30 percent in color during stor- water solution used to age. spray surfaces of cured cuts, prior to packaging, in accordance with 21 CFR 184.1033. (The use of such solution shall not result in the addition of a significant amount of moisture to the product and shall be applied only once to product). Citric acid (sodium To acidify ...... Margarine and oleo- Sufficient for purpose. and potassium margarine. salts). d- and dl-alpha-to- To inhibit nitrosa- Pump-cured bacon ...... 500 ppm; by injection or copherol. mine formation. surface application.

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Class of substance Substance Purpose Products Amount

Dipotassium phos- To decrease the Meat food products except For meat food products, 5 phate. amount of cooked where otherwise prohib- percent of phosphate in out juices. ited by the meat inspec- pickle at 10 percent pump tion regulations and poul- level; 0.5 percent of phos- try food products except phate in meat food prod- where otherwise prohib- uct (only clear solution ited by the poultry prod- may be injected into meat ucts inspection regula- food product). For poultry tions.. food products, 0.5 percent of total product. Disodium phosphate ...... do ...... do ...... Do. Glycerine ...... Humectant ...... Shelf stable meat snacks ... Not to exceed 2 percent of the formulation weight of the product in accordance with 21 CFR 182.1320. Hydrochloric acid .... To acidify ...... Margarine or oleomargarine Sufficient for purpose. Lactic acid (sodium ...... do ...... do ...... Do. and potassium salts). L-Tartaric acid (so- ...... do ...... do ...... Do. dium and sodium potassium salts). Monopotassium To decrease the Meat food products except For meat food products, 5 phosphate. amount of cooked where otherwise prohib- percent of phosphate in out juices. ited by the meat inspec- pickle at 10 percent pump tion regulations and poul- level; 0.5 percent of phos- try food products except phate in meat food prod- where otherwise prohib- uct (only clear solution ited by the poultry prod- may be injected into meat ucts inspection regula- food product). For poultry tions.. products, 0.5 percent of total product. Monosodium phos- ...... do ...... do ...... Do. phate. Phosphoric acid ...... To acidify ...... Margarine or oleomargarine Sufficient for purpose. Potassium bicarbon- To alkalize ...... Margarine or oleomargarine Sufficient for purpose. ate. Potassium car- ...... do ...... do ...... Do. bonate. Potassium To decrease the Meat food products except 5 percent of phosphate in pyrophosphate. amount of cooked where otherwise prohib- pickle at 10 percent pump out juices. ited by the meat inspec- level; 0.5 percent of phos- tion regulations and poul- phate in meat food prod- try food products except uct (only clear solution where otherwise prohib- may be injected into meat ited by the poultry prod- food product). For poultry ucts inspection regula- food products, 0.5 per- tions.. cent of total product. Potassium sorbate .. To retard mold Dry sausage ...... 10 percent in water solution growth. may be applied to casings after stuffing or casings may be dipped in solution prior to stuffing. Potassium To decrease the Meat food products except 5 percent of phosphate in tripolyphosphate. amount of cooked where otherwise prohib- pickle at 10 percent pump out juices. ited by the meat inspec- level; 0.5 percent of phos- tion regulations and poul- phate in meat food prod- try food products except uct (only clear solution where otherwise prohib- may be injected into meat ited by the poultry prod- food product). For poultry ucts inspection regula- food products, 0.5 per- tions. cent of total product. Propyl paraben To retard mold Dry sausage ...... 3.5 percent in water solution (propyl p-hydroxy- growth. may be applied to cas- benzoate). ings after stuffing or casings may be dipped in solution prior to stuffing. Silicon dioxide ...... Processing aid/dis- Tocopherol containing At level not to exceed 4.0 persant. bacon curing mixes. percent in the dry mix.

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Class of substance Substance Purpose Products Amount

Sodium acid To decrease the Meat food products except For meat food products, 5 pyrophosphate. amount of cooked where other prohibited by percent of phosphate in out juices. the meat inspection regu- pickle at 10 percent pump lations and poultry food level; 0.5 percent of phos- products except where phate in meat food prod- otherwise prohibited by uct (only clear solution the poultry products in- may be injected into meat spection regulations.. food product). For poultry products, 0.5 percent of total product. Sodium bicarbonate To neutralize excess Rendered fats, soups, cur- Sufficient for purpose. acidity, cleaning ing pickle (meat and poul- vegetables. try). To alkalize ...... Margarine or oleomargarine Do. Sodium carbonate ...... do ...... do ...... Do. Sodium citrate To inhibit the growth Cured and uncured, proc- Not to exceed 1.3 percent buffered with citric of micro-orga- essed whole muscle meat of the formulation weight acid to a pH of nisms and retain and poultry food products, of the product in accord- 5.6. product flavor dur- e.g., ham, chicken ance with 21 CFR ing storage. breasts. 184.1751. Sodium hydroxide ... To alkalize ...... Margarine or oleomargarine Sufficient for purpose. To decrease the Poultry food products con- May be used only in com- amount of cooked taining phosphates. bination with phosphate in out juices. a ratio not to exceed one part sodium hydroxide to four parts phosphate...... do ...... Meat food products con- May be used only in com- taining phosphates. bination with phosphates in a ratio not to exceed one part sodium hydroxide to four parts phosphate; the combination shall not exceed 5 percent in pickle at 10 percent pump level; 0.5 percent in product. Sodium ...... do ...... Meat food products except For meat food products, 5 metaphosphate, where other prohibited by percent of phosphate in insoluble. the meat inspection regu- pickle at 10 percent pump lations, and poultry food level; 0.5 percent of phos- products except where phate in meat food prod- otherwise prohibited by uct (only clear solution the poultry products in- may be injected into meat spection regulations. food product). For poultry products, 0.5 percent of total product. Sodium ...... do ...... do ...... Do. polyphosphate, glassy. Sodium proprionate To retard mold Pizza crust ...... 0.32 percent alone or in growth. combination based on weight of the flour brace used...... do ...... Fresh pie dough (poultry 0.3 percent of calcium only). proprionate or sodium proprionate alone, or in combination, based on weight of flour used. Sodium To decrease the Meat food products except For meat food products, 5 pryophosphate. amount of cooked where otherwise prohib- percent of phosphate in out juices. ited by the meat inspec- pickle at 10 percent pump tion regulations and poul- level; 0.5 percent of phos- try food products except phate in meat food prod- where otherwise prohib- uct (only clear solution ited by the poultry prod- may be injected into meat ucts inspection regula- food product). For poultry tions. products, 0.5 percent of total product. Sodium ...... do ...... do ...... Do. tripolyphosphate.

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Class of substance Substance Purpose Products Amount

Sorbic acid (sodium, To preserve product Margarine or oleomargarine 0.1 percent individually, or if potassium, and and to retard mold used in combination or calcium salts). growth. with benzoic acid or its salts, 0.2 percent (expressed as the acids in the wt. of the finished foods). Tricalcium phos- To preserve product Mechanically deboned Not to exceed 2 percent of phate. color during dehy- chicken to be dehydrated. the weight of the me- dration process. chanically deboned chicken prior to dehydration, in accordance with 21 CFR 182.1217. Poultry scald agents Alpha-hydro-omega- To remove feathers Poultry carcasses ...... Not to exceed 0.05 percent (must be removed hydroxy-poly (oxy- by weight in scald water. by subsequent ethylene) poly cleaning oper- (oxypropylene) ations). (minimum 15 moles) poly (oxy- ethylene) block copolymer (poloxamer). Dimethylpolysiloxan- ...... do ...... do ...... Sufficient for purpose. e. Dioctyl sodium ...... do ...... do ...... Do. sulfosuccinate. Dipotassium phos- ...... do ...... do ...... Do. phate. Ethylenediaminetetr- ...... do ...... do ...... Do. a-acetic acid (sodium salts). Lime (calcium oxide, ...... do ...... do ...... Do. calcium hydroxide). Polyoxyethylene ...... do ...... do ...... Not to exceed 0.0175 per- (20) sorbitan cent in scald water. monooleate. Potassium hydrox- ...... do ...... do ...... Sufficient for purpose. ide. Propylene glycol ...... do ...... do ...... Do. Sodium acid phos- ...... do ...... do ...... Do. phate. Sodium acid ...... do ...... do ...... Do. pyrophosphate. Sodium bicarbonate ...... do ...... do ...... Do. Sodium carbonate ...... do ...... do ...... Do. Sodium ...... do ...... do ...... Do. dodecylbenzene- sulfonate. Sodium-2-ethylhexyl ...... do ...... do ...... Do. sulfate. Sodium ...... do ...... do ...... Do. hexametaphosph- ate. Sodium hydroxide ...... do ...... do ...... Do. Sodium lauryl sul- ...... do ...... do ...... Do. fate. Sodium phosphate ...... do ...... do ...... Do. (mono-, di-, tribasic). Sodium ...... do ...... do ...... Do. pyrophosphate. Sodium ...... do ...... do ...... Do. sesquicarbonate. Sodium sulfate ...... do ...... do ...... Do. Sodium ...... do ...... do ...... Do. tripolyphosphate. Tetrasodium ...... do ...... do ...... Do. pyrophosphate.

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Class of substance Substance Purpose Products Amount

Proteolytic Enzymes Aspergillus flavus To soften tissue ...... Raw poultry muscle tissue Solutions consisting of oryzae group. of hen, cock, mature tur- water and approved key, mature duck, mature proteolytic enzyme ap- goose, and mature guin- plied or injected into raw ea, and raw meat cuts. meat or poultry tissue shall not result in a gain of more than 3 percent above the weight of the untreated product. Aspergillus oryzae ...... do ...... do ...... Do. Bromelin ...... do ...... do ...... Do. Ficin ...... do ...... do ...... Do. Papain ...... do ...... do ...... Do. Refining Agents Acetic acid ...... To separate fatty Rendered fats (meat only) .. Sufficient for purpose. (must be elimi- acids and glycerol. nated during process of manufacturing). Bicarbonate of soda ...... do ...... do ...... Do. Carbon (purified To aid in refining of ...... do ...... Do. charcoal). animal fats. Caustic soda (so- To refine fats ...... do ...... Do. dium hydroxide). Diatomaceous earth; ...... do ...... do ...... Do. Fuller’s earth. Sodium carbonate ...... do ...... do ...... Do. Tannic acid ...... do ...... do ...... Do. Rendering agents ..... Tricalcium phos- To aid rendering ..... Animal fats ...... Do. phate. Trisodium phos- ...... do ...... do ...... Do. phate. Synergists (used in Citric acid ...... To increase effec- Any meat product permitted Not to exceed 0.01 percent combination with tiveness of anti- to contain antioxidants as based on fat content. antioxidants). oxidants. provided for in this part...... do ...... Poultry fats ...... 0.01 percent alone or in combination with antioxidants in poultry fats. Malic acid ...... do ...... Lard and shortening ...... 0.01 percent based on total weight in combination with antioxidants for use in meat products only...... do ...... Poultry fats ...... 0.01 percent alone or in combination with antioxidants in poultry fats. Monoglyceride cit- ...... do ...... Lard, shortening, fresh pork 0.02 percent. rate. sausage, dried meats and poultry fats. Monoisopropyl cit- ...... do ...... Lard, shortening, oleo- Do. rate. margarine, fresh pork sausage, dried meats...... do ...... Poultry fats ...... 0.01 percent poultry fats. Phosphoric acid ...... do ...... Lard, shortening, and poul- 0.01 percent. try fats. Tenderizing agents .. Aspergillus flavus To soften tissue ...... Raw poultry muscle tissue Solutions consisting of oryzae group. of hen, cock, mature tur- water and approved key, mature duck, mature proteolytic enzyme ap- goose, and mature guin- plied or injected into raw ea, and raw meat cuts. meat or poultry tissue shall not result in a gain of more than 3 percent above the weight of the untreated product. Aspergillus oryzae ...... do ...... do ...... Not more than 3 percent of a 0.8 molar solution. Bromelin ...... do ...... do ...... Do. Calcium chloride ...... do ...... do ...... Do. Magnesium chloride ...... do ...... do ...... Do.

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Class of substance Substance Purpose Products Amount

Papain ...... To soften tissue ...... Raw poultry muscle tissue Solutions consisting of of hen, cock, mature tur- water and approved key, mature duck, mature proteolytic enzyme ap- goose, and mature guin- plied or injected into raw ea, and raw meat cuts. meat or poultry tissue shall not result in a gain of more than 3 percent above the weight of the untreated product. Potassium chloride ...... do ...... do ...... Not more than 3 percent of a 2.0 molar solution. Potassium, magne- ...... do ...... do ...... A solution of approved inor- sium or calcium ganic chlorides injected chloride. into or applied to raw meats or poultry cuts shall not result in a gain of more than 3 percent above the weight of the untreated product. 1 [Reserved] 2 Information as to the specific products for which use of this additive is approved may be obtained upon inquiry addressed to the Labeling and Additives Policy Division, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250. 3 Provided, that its use is functional and suitable for the product and it is permitted for use at the lowest level necessary to accomplish the desired technical effect as determined in specific cases prior to label approval under §§ 317.4 or 381.32. 4 Special labeling requirements are prescribed in 381.120 for raw poultry chilled in a medium with more than 70 lbs. of salt to 10,000 gals. of water.

[64 FR 72175, Dec. 23, 1999, as amended at 65 FR 3123, Jan. 20, 2000; 65 FR 34391, May 30, 2000]

§ 424.22 Certain other permitted uses. in specific cases. When any coloring matter or dye is applied to casings, (a) Under appropriate declaration as there shall be no penetration of color- required in parts 316 and 317 of this ing into the product. chapter, the following substances may (b) Use of nitrite and sodium ascorbate be added to meat: or sodium erythorbate (isoascorbate) in (1) General. Common salt, approved bacon—(1) Pumped bacon. With respect sugars (sucrose, cane or beet sugar), to bacon injected with curing ingredi- maple sugar, dextrose, invert sugar, ents and massaged bacon, sodium ni- honey, corn syrup solids (corn syrup, trite shall be used at 120 parts per mil- glucose syrup and fructose), wood lion (ppm) ingoing or an equivalent smoke, vinegar, flavorings, spices, so- amount of potassium nitrite shall be dium nitrate, sodium nitrite, potas- used (148 ppm ingoing); and 550 ppm of sium nitrate, potassium nitrite, and sodium ascorbate or sodium other food and color additives specified erythorbate (isoascorbate) shall be in the chart in paragraph (c) of this used. Sodium ascorbate or sodium section may be added to meat under erythorbate have a molecular weight of conditions, if any, specified in this part approximately 198. Hydrated forms of or in part 317 of this chapter. these substances shall be adjusted to (2) Artificial flavorings. Other harm- attain the equivalent of 550 ppm of so- less artificial flavorings may be added dium ascorbate or sodium erythorbate. to meat, with the approval of the Ad- (i) The Department shall collect sam- ministrator in specific cases. ples of pumped bacon from producing (3) Coloring matter and dyes. Coloring plants and analyze them for the level matter and dyes, other than those of nitrosamines by the Thermal Energy specified in a regulation permitting Analyzer (TEA). In the event that a that use in this chapter or in 21 CFR TEA analysis indicates that a confirm- Chapter I, Subchapter A and Sub- able level of nitrosamines might be chapter B, may be applied to meat present, additional samples shall be mixed with rendered fat, applied to collected and analyzed by gas chroma- natural and artificial casings, and ap- tography. Presumptive positive results plied to such casings enclosing prod- must be confirmed by mass spectrom- ucts, if approved by the Administrator etry before being considered positive. If

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during the interval required for the De- product and laboratory results ob- partment to analyze the confirmatory tained by TEA analysis of samples samples by gas chromatography and from five consecutive normal sized lots mass spectrometry, changes are made of pumped bacon indicates that the in processing procedures which are ex- product being produced contains no pected to result in no confirmable lev- confirmable levels of nitrosamines. els of nitrosamines in pumped bacon These tests from five consecutive nor- produced by these new procedures, an mal sized lots of pumped bacon shall be establishment may submit samples to conducted by the Department. How- USDA for analysis upon prior notifica- ever, if the establishment furnishes the tion and arrangements with USDA. If, Department with the results of tests however, an establishment furnishes conducted under the methodology and USDA with laboratory results from procedures used by the Department, testing five consecutive lots of pumped such test results will be utilized in bacon produced under the new proce- making the determination concerning dures and the testing is performed by the nitrosamine content of the prod- the USDA methodology and proce- uct. All tests of pumped bacon for dures, those results will be utilized in nitrosamines under this paragraph making the determination concerning (b)(1)(i) shall be made on pumped bacon the product produced under the new cooked at 340 degrees F. for 3 minutes procedures. Should the results of these on each side. In order to determine tests reveal that confirmable levels of that no confirmable levels of nitrosamines are not indicated in any nitrosamines are present in a sample of the five consecutive lots, the con- tested, the testing must be performed firmation analysis by USDA shall be by methodology and procedures that terminated and the establishment shall would detect the presence of any revert to normal monitoring status. In nitrosamines at 10 ppb. the event the test results continue to (ii) Notwithstanding the provisions of indicate nitrosamines, however, USDA paragraph (b)(1)(i) of this section, so- shall proceed in its confirmation anal- dium nitrite may be used at: ysis on the original samples taken for (A) 100 ppm ingoing (potassium ni- confirmation. If any one of the original trite at 123 ppm ingoing); and 550 ppm samples collected by USDA for con- sodium ascorbate or sodium firmation is found to contain confirm- erythorbate (isoascorbate) shall be able levels of nitrosamines, all pumped used; or bacon in the producing establishment (B) A predetermined level between 40 and all future production will be re- and 80 ppm (potassium nitrite at a tained. The Department shall sample level between 49 and 99 ppm); 550 ppm and analyze such retained pumped sodium ascorbate or sodium bacon for nitrosamines on a lot by lot erythorbate (isoascorbate); and addi- basis. A production lot shall be that tional sucrose or other similar fer- pumped bacon produced by the estab- mentable carbohydrate at a minimum lishment in any single shift. Samples of 0.7 percent and an inoculum of lactic from any lot of pumped bacon under re- acid producing bacteria such as tention found to contain nitrosamines Pediococcus acetolactii or other bacteria at a confirmable level shall cause the demonstrated to be equally effective in lot of pumped bacon to be disposed of preventing the production of botu- in a manner to ensure it will not form linum toxin at a level sufficient for the nitrosamines when cooked. Such dis- purpose of preventing the production of posal may include incorporation of the botulinum toxin. uncooked pumped bacon as an ingre- (C) The Department shall collect dient of another meat provided it is samples of bacon from establishments processed for eating without further producing under paragraph (b)(1)(ii) of preparation in a manner to preclude this section and analyze them for the the formation of nitrosamines. Bacon level of nitrosamines. Samples shall be subsequently produced shall not be re- randomly selected throughout the pro- tained because of nitrosamines if the duction of a lot. The actual sampling operator of the establishment makes plans and methods of analysis that are adjustments in the processing of the used will result in approximately the

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same likelihood as under paragraph (iii) Calibration and accountability (b)(1)(i) of this section of having a pre- criteria for verifying the traceability sumptive positive result when the true and accuracy of dosimeters for the in- mean level of nitrosamines in a produc- tended purpose, and the verification of tion lot is 10 ppb. In the event of a pre- calibration at least every 12 months. sumptive positive result, the establish- To confirm traceability, establishment shall become subject to the pro- ments must relate, through docu- visions of paragraph (b)(1)(i) of this mentation, the end point measurement section. of a dosimeter to recognized standards. (2) Immersion cured bacon. Immersion (iv) Procedures for ensuring that the cured bacon may be placed in a brine product unit is dose mapped to identify solution containing salt, nitrite and the regions of minimum and maximum flavoring material or in a container absorbed dose and such regions are con- with salt, nitrite and flavoring mate- sistent from one product unit to an- rial. Sodium nitrite shall not exceed other of like product. 120 ppm ingoing or an equivalent (v) Procedures for accounting for the amount of potassium nitrite (148 ppm total absorbed dose received by the ingoing) based on the actual or esti- product unit (e.g., partial applications mated skin-free green weight of the of the absorbed dose within one produc- bacon bellies. tion lot). (3) Bacon made with dry curing mate- (vi) Procedures for verifying routine rials. With respect to bacon made with dosimetry, i.e., assuring each produc- dry curing materials, the product shall tion lot receives the total absorbed be cured by applying a premeasured dose. Establishments may either posi- amount of cure mixture to the bacon tion one dosimeter at the regions of belly surfaces, completely covering the minimum and maximum absorbed dose surfaces. Sodium nitrite shall not ex- (or at one region verified to represent such) on at least the first, middle, and ceed 200 ppm ingoing or an equivalent last product unit in each production amount of potassium nitrite (246 ppm lot or use statistically based validation ingoing) in dry cured bacon based on and dose mapping to determine the the actual or estimated skin-free green number and placement of dosimeters in weight of the bacon belly. each production lot. (c) Irradiation of meat food and poul- (vii) Procedures for verifying the re- try products. lationship of absorbed dose as meas- (1) General requirements. Meat food ured by the dosimeter to time exposure and poultry products may be treated to of the product unit to the radiation reduce foodborne pathogens and to ex- source. tend product shelf-life by the use of (viii) Procedures for verifying the in- sources of ionizing radiation as identi- tegrity of the radiation source and fied in 21 CFR 179.26(a). Official estab- processing procedure. Aside from ex- lishments must irradiate meat food pected and verified radiation source ac- and poultry products in accordance tivity decay for radionuclide sources, with 21 CFR 179.26(b), the Hazard Anal- the radiation source or processing pro- ysis and Critical Control Point cedure must not be altered, modified, (HACCP) system requirements in part replenished, or adjusted without re- 417 of this chapter, and the provisions peating dose mapping of product units of this section. to redefine the regions of minimum (2) Dosimetry. Official establishments and maximum absorbed dose. that irradiate meat food and poultry (3) Documentation. Official establish- products must have the following pro- ments that irradiate meat food or poul- cedures in place: try products must have the following (i) Laboratory operation procedures documentation on premises, available for determining the absorbed dose to FSIS: value from the dosimeter. (i) Documentation that the irradia- (ii) Calibration criteria for verifying tion facility is licensed or possesses the accuracy and consistency of any gamma radiation sources registered means of measurement (e.g., time with the Nuclear Regulatory Commis- clocks and weight scales). sion (NRC) or the appropriate State

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government acting under authority granted by the NRC. (ii) Documentation that the machine radiation source irradiation facility is registered with the appropriate State government, if applicable. (iii) Documentation that a worker safety program addressing OSHA regulations (29 CFR chapter XVII) is in place. (iv) Citations or other documents that relate to incidences in which the (ii) For meat food or poultry prod- establishment was found not to comply ucts that have been irradiated in their with Federal or State agency require- entirety, but that are not sold in pack- ments for irradiation facilities. ages, the required logo must be dis- (v) A certification by the operator played to the purchaser with either the that the irradiation facility personnel labeling of the bulk container plainly will only operate under supervision of a in view or a counter sign, card, or person who has successfully completed other appropriate device bearing the a course of instruction for operators of information that the product has been food irradiation facilities. treated with radiation. In either case, (vi) A certification by the operator the information must be prominently that the key irradiation personnel, who and conspicuously displayed to pur- monitor or control daily operations, chasers. Unless the word ‘‘Irradiated’’ have been trained in food technology, is part of the product name, the label- irradiation processing, and radiation ing counter sign, card, or other device health and safety. also must bear a statement such as (vii) Guarantees from the suppliers of ‘‘Treated with radiation’’ or ‘‘Treated all food-contact packaging materials by irradiation.’’ The logo must be that may be subject to irradiation that placed in conjunction with the required those materials comply with the Fed- statement, if the statement is used. eral Food, Drug, and Cosmetic Act (21 (iii) The inclusion of an irradiated U.S.C. 301 et seq.). meat food or poultry product ingredient in any multi-ingredient meat (4) Labeling. (i) The labels on pack- food or poultry product must be re- ages of meat food and poultry products flected in the ingredient statement on irradiated in their entirety, in con- the finished product labeling. formance with this section and with 21 (iv) Optional labeling statements CFR 179.26(a) and (b), must bear the about the purpose for radiation proc- logo shown at the end of this paragraph essing may be included on the product (c)(4)(i). Unless the word ‘‘Irradiated’’ label in addition to the stated require- is part of the product name, labels also ments elsewhere in this section, pro- must bear a statement such as ‘‘Treat- vided that such statements are not ed with radiation’’ or ‘‘Treated by irra- false or misleading. Statements that diation.’’ The logo must be placed in there has been a specific reduction in conjunction with the required state- microbial pathogens must be substan- ment, if the statement is used. The tiated by processing documentation. statement is not required to be more prominent than the declaration of in- [64 FR 72175, Dec. 23, 1999, as amended at 64 FR 72165, Dec. 23, 1999; 65 FR 34391, May 30, gredients required under § 317.2(c)(2). 2000] Any label bearing the logo or any wording of explanation with respect to § 424.23 Prohibited uses. this logo must be approved as required (a) Substances that conceal damage or by Section 317.4. of this chapter or sub- inferiority or make products appear better parts M and N of part 381. or of greater value. No substance may be used in or on any meat if it conceals damage or inferiority or makes the

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product appear to be better or of great- product that has the effect of super value than it is. Therefore: pressing or limiting the growth of a (1) Paprika or oleoresin paprika may microorganism, such as L. not be used in or on fresh meat, such as monocytogenes, in the product through- steaks, or comminuted fresh meat, out the shelf life of the product. such as chopped and formed steaks or Deli product. A ready-to-eat meat or patties; or in any other meat con- poultry product that typically is sisting of fresh meat (with or without sliced, either in an official establish- seasoning). ment or after distribution from an offi- (2) Paprika or oleoresin paprika may cial establishment, and typically is as- be used in or on chorizo sausage and sembled in a sandwich for consump- other meat in which paprika or oleo- tion. resin paprika is permitted as an ingre- Hotdog product. A ready-to-eat meat dient in a standard of identity or com- or poultry frank, frankfurter, or wie- position in part 319 of this subchapter. ner, such as a product defined in 9 CFR (3) Sorbic acid, calcium sorbate, so- 319.180 and 319.181. dium sorbate, and other salts of sorbic Lethality treatment. A process, includ- acid shall not be used in cooked sau- ing the application of an antimicrobial sages or any other meat; sulfurous acid agent, that eliminates or reduces the and salts of sulfurous acid shall not be number of pathogenic microorganisms used in or on any meat; and niacin or on or in a product to make the product nicotinamide shall not be used in or on safe for human consumption. Examples fresh meat product; except that potas- of lethality treatments are cooking or sium sorbate, propylparaben (propyl p- the application of an antimicrobial hydroxybenzoate), calcium propionate, agent or process that eliminates or re- sodium propionate, benzoic acid, and duces pathogenic microorganisms. sodium benzoate may be used in or on Post-lethality exposed product. Ready- any product, only as provided in 9 CFR to-eat product that comes into direct Chapter III. contact with a food contact surface (b) Nitrates. Nitrates shall not be used after the lethality treatment in a post- in curing bacon. lethality processing environment. Post-lethality processing environment. PART 430—REQUIREMENTS FOR The area of an establishment into SPECIFIC CLASSES OF PRODUCT which product is routed after having been subjected to an initial lethality Sec. treatment. The product may be ex- 430.1 Definitions. posed to the environment in this area 430.4 Control of Listeria monocytogenes in as a result of slicing, peeling, re-bag- post-lethality exposed ready-to-eat prod- ging, cooling semi-permeable encased ucts. product with a brine solution, or other AUTHORITY: 7 U.S.C. 450; 7 U.S.C. 1901–1906; procedures. 21 U.S.C. 451–470, 601–695; 7 CFR 2.18, 2.53. Post-lethality treatment. A lethality SOURCE: 68 FR 34224, June 6, 2003, unless treatment that is applied or is effective otherwise noted. after post-lethality exposure. It is applied to the final product or sealed § 430.1 Definitions. package of product in order to reduce Antimicrobial agent. A substance in or or eliminate the level of pathogens re- added to an RTE product that has the sulting from contamination from post- effect of reducing or eliminating a lethality exposure. microorganism, including a pathogen Prerequisite program. A procedure or such as L. monocytogenes, or that has set of procedures that is designed to the effect of suppressing or limiting provide basic environmental or oper- growth of L. monocytogenes in the prod- ating conditions necessary for the pro- uct throughout the shelf life of the duction of safe, wholesome food. It is product. Examples of antimicrobial called ‘‘prerequisite’’ because it is con- agents added to RTE products are po- sidered by scientific experts to be pre- tassium lactate and sodium diacetate. requisite to a HACCP plan. Antimicrobial process. An operation, Ready-to-eat (RTE) product. A meat or such as freezing, applied to an RTE poultry product that is in a form that

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is edible without additional prepara- tablishment must document, either in tion to achieve food safety and may re- its HACCP plan or in its Sanitation ceive additional preparation for palat- SOP or other prerequisite program, ability or aesthetic, epicurean, gastro- that the antimicrobial agent or proc- nomic, or culinary purposes. RTE prod- ess, as used, is effective in suppressing uct is not required to bear a safe-han- or limiting growth of L. monocytogenes. dling instruction (as required for non- (2) Alternative 2. Use of either a post- RTE products by 9 CFR 317.2(l) and lethality treatment (which may be an 381.125(b)) or other labeling that directs antimicrobial agent) that reduces or that the product must be cooked or eliminates microorganisms on the otherwise treated for safety, and can product or an antimicrobial agent or include frozen meat and poultry prod- process that suppresses or limits ucts. growth of L. monocytogenes. If an establishment chooses this alternative: § 430.4 Control of Listeria (i) The post-lethality treatment must monocytogenes in post-lethality ex- be included in the establishment’s posed ready-to-eat products. HACCP plan. The antimicrobial agent (a) Listeria monocytogenes can con- or process used to suppress or limit taminate RTE products that are ex- growth of the pathogen must be in- posed to the environment after they cluded in either the establishment’s have undergone a lethality treatment. HACCP plan or its Sanitation SOP or L. monocytogenes is a hazard that an es- other prerequisite program. tablishment producing post-lethality (ii) The establishment must validate exposed RTE products must control the effectiveness of a post-lethality through its HACCP plan or prevent in treatment incorporated in its HACCP the processing environment through a plan in accordance with § 417.4. The es- Sanitation SOP or other prerequisite tablishment must document in its program. RTE product is adulterated if HACCP plan or in its Sanitation SOP it contains L. monocytogenes or if it or other prerequisite program that the comes into direct contact with a food antimicrobial agent or process, as used, contact surface which is contaminated is effective in suppressing or limiting with L. monocytogenes. growth of L. monocytogenes. (b) In order to maintain the sanitary (iii) If an establishment chooses this conditions necessary to meet this re- alternative and chooses to use only an quirement, an establishment producing antimicrobial agent or process that post-lethality exposed RTE product suppresses or limits the growth of L. must comply with the requirements in- monocytogenes, its sanitation program cluded in one of the three following al- must: ternatives: (A) Provide for testing of food con- (1) Alternative 1. Use of a post- tact surfaces in the post-lethality proc- lethality treatment (which may be an essing environment to ensure that the antimicrobial agent) that reduces or surfaces are sanitary and free of L. eliminates microorganisms on the monocytogenes or of an indicator orga- product and an antimicrobial agent or nism; process that suppresses or limits the (B) Identify the conditions under growth of L. monocytogenes. If an estab- which the establishment will imple- lishment chooses this alternative: ment hold-and-test procedures fol- (i) The post-lethality treatment must lowing a positive test of a food-contact be included in the establishment’s surface for L. monocytogenes or an indi- HACCP plan. The antimicrobial agent cator organism; or process used to suppress or limit the (C) State the frequency with which growth of the pathogen must be in- testing will be done; cluded in either the establishment’s (D) Identify the size and location of HACCP plan or its Sanitation SOP or the sites that will be sampled; and other prerequisite program. (E) Include an explanation of why the (ii) The establishment must validate testing frequency is sufficient to en- the effectiveness of the post-lethality sure that effective control of L. treatment incorporated in its HACCP monocytogenes or of indicator orga- plan in accordance with § 417.4. The es- nisms is maintained.

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(iv) An establishment that chooses are necessary to ensure the effective- this alternative and uses a post- ness of the corrective actions. lethality treatment of product will (B) During this follow-up testing, if likely be subject to more frequent the establishment obtains a second verification testing by FSIS than if it positive test for L. monocytogenes or an had chosen Alternative 1. An establish- indicator organism, the establishment ment that chooses this alternative and must hold lots of product that may uses an antimicrobial agent or process have become contaminated by contact that suppresses or limits the growth of with the food contact surface until the L. monocytogenes will likely be subject establishment corrects the problem in- to more frequent FSIS verification dicated by the test result. testing than if it uses a post-lethality (C) Further, in order to be able to re- treatment. lease into commerce the lots of prod- (3) Alternative 3. Use of sanitation uct that may have become contami- measures only. nated with L. monocytogenes, the estab- (i) If an establishment chooses this lishment must sample and test the lots alternative, its sanitation program for L. monocytogenes or an indicator or- must: ganism using a sampling method and (A) Provide for testing of food con- frequency that will provide a level of tact surfaces in the post-lethality proc- statistical confidence that ensures that essing environment to ensure that the each lot is not adulterated with L. surfaces are sanitary and free of L. monocytogenes. The establishment must monocytogenes or of an indicator orga- document the results of this testing. nism; Alternatively, the establishment may (B) Identify the conditions under rework the held product using a proc- which the establishment will imple- ess that is destructive of L. ment hold-and-test procedures fol- monocytogenes or the indicator orga- lowing a positive test of a food-contact nism. surface for L. monocytogenes or an indi- (iii) An establishment that chooses cator organism; Alternative 3 is likely to be subject to (C) State the frequency with which more frequent verification testing by testing will be done; FSIS than an establishment that has (D) Identify the size and location of chosen Alternative 1 or 2. An establish- the sites that will be sampled; and ment that chooses Alternative 3 and (E) Include an explanation of why the that produces deli meat or hotdog testing frequency is sufficient to en- products is likely to be subject to more sure that effective control of L. frequent verification testing than one monocytogenes or of indicator orga- that does not produce such products. nisms is maintained. (c) For all three alternatives in para- (ii) An establishment producing a graph (b): deli product or a hotdog product, in ad- (1) Establishments may use dition to meeting the requirements of verification testing that includes tests paragraph (b)(3)(i) of this section, must for L. monocytogenes or an indicator or- meet the following requirements: ganism, such as Listeria species, to (A) The establishment must verify verify the effectiveness of their sanita- that the corrective actions that it tion procedures in the post-lethality takes with respect to sanitation after processing environment. an initial positive test for L. (2) Sanitation measures for control- monocytogenes or an indicator organism ling L. monocytogenes and procedures on a food contact surface in the post- for antimicrobial agents or processes lethality processing environment are that suppress or limit the growth of effective by conducting follow-up test- the pathogen may be incorporated ei- ing that includes a targeted test of the ther in the establishment’s HACCP specific site on the food contact sur- plan or in its Sanitation SOP or other face area that is the most likely source prerequisite program. When these con- of contamination by the organism and trol procedures are incorporated into such additional tests in the sur- the Sanitation SOP or prerequisite pro- rounding food contact surface area as gram, and not as a CCP in the HACCP

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plan, the establishment must have doc- PART 439—ACCREDITATION OF umentation that supports the decision NON-FEDERAL CHEMISTRY LAB- in its hazard analysis that L. ORATORIES monocytogenes is not a hazard that is reasonably likely to occur. Sec. (3) The establishment must maintain 439.1 Definitions. sanitation in the post-lethality proc- 439.5 Applications for accreditation. essing environment in accordance with 439.10 Criteria for obtaining accreditation. part 416. 439.20 Criteria for maintaining accredita- (4) If L. monocytogenes control meas- tion. ures are included in the HACCP plan, 439.50 Refusal of accreditation. the establishment must validate and 439.51 Probation of accreditation. 439.52 Suspension of accreditation. verify the effectiveness of measures for 439.53 Revocation of accreditation. controlling L. monocytogenes included 439.60 Notifications and hearings. in its HACCP plan in accordance with § 417.4. AUTHORITY: 7 U.S.C. 138f, 450, 1901–1906; 21 U.S.C. 451–470, 601–695; 7 CFR 2.18, 2.53. (5) If L. monocytogenes control measures are included in the Sanitation SOURCE: 73 FR 52196, Sept. 9, 2008, unless SOP, the effectiveness of the measures otherwise noted. must be evaluated in accordance with § 439.1 Definitions. § 416.14. (6) If the measures for addressing L. (a) Accreditation—Determination by monocytogenes are addressed in a pre- FSIS that a laboratory is qualified to requisite program other than the Sani- analyze official samples of raw or proc- tation SOP, the establishment must in- essed meat and poultry products, be- clude the program and the results pro- cause it has met the requirements for accreditation specified in this part, for duced by the program in the docu- the presence and amount of all four mentation that the establishment is food chemistry analytes (protein, mois- required to maintain under 9 CFR 417.5. ture, fat, and salt); or a determination (7) The establishment must make the by FSIS that a laboratory is qualified verification results that demonstrate to analyze official samples of raw or the effectiveness of the measures it processed meat and poultry products, employs, whether under its HACCP because it has met the requirements plan or its Sanitation SOP or other for accreditation in this part, for the prerequisite program, available upon presence and amount of a specified request to FSIS inspection personnel. chemical residue of any one of several (d) An establishment that produces classes of chemical residues. A labora- post-lethality exposed RTE product tory may hold more than one accredi- shall provide FSIS, at least annually, tation. or more often, as determined by the (b) Accredited laboratory—A non-Fed- Administrator, with estimates of an- eral analytical laboratory that has met nual production volume and related in- the requirements for accreditation formation for the types of meat and specified in this Part and, therefore, at poultry products processed under each an establishment’s discretion, may be of the alternatives in paragraph (b) of used in lieu of an FSIS laboratory for this section. analyzing official regulatory samples. (e) An establishment that controls L. Payment for the analysis of official samples is to be made by the establish- monocytogenes by using a post-lethality ment using the accredited laboratory. treatment or an antimicrobial agent or (c) Accredited Laboratory Program process that eliminates or reduces, or (ALP)—The FSIS program in which suppresses or limits the growth of the non-Federal laboratories are accredited organism may declare this fact on the as eligible to perform analyses on offi- product label provided that the estab- cial regulatory samples of raw or proc- lishment has validated the claim. essed meat and poultry products, and through which a check sample program for quality assurance is conducted.

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(d) Chemical residue misidentification— (2) Negative systematic laboratory see ‘‘Correct chemical residue identi- difference CUSUM (CUSUM–N)—mon- fication’’ definition. itors how consistently an accredited (e) Coefficient of variation (CV)—The laboratory gets numerically smaller standard deviation of a distribution of results than the comparison mean; analytical values multiplied by 100 and (3) Variability CUSUM (CUSUM–V)— divided by the mean of those values. monitors the average ‘‘total deviation’’ (f) Comparison mean—The average re- (i.e., the combination of the random sult, for a sample, obtained from all fluctuations and systematic dif- submitted results that have a large de- ferences) between an accredited labora- viation measure of zero. When only two tory’s results and the comparison laboratories perform the analysis and mean; and the large deviation measure is not zero, (4) Individual large deviation CUSUM alternative procedures for establishing (CUSUM–D)—monitors the magnitude a comparison mean may be employed and frequency of large differences be- by FSIS. For purposes of computing tween the results of an accredited lab- the comparison mean, a laboratory’s oratory and the comparison mean. ‘‘result’’ for a food chemistry analyte (i) Food chemistry—For the purposes is the obtained analytical value; a lab- of part 439, ‘‘food chemistry’’ will refer oratory’s ‘‘result’’ for a chemical res- to analysis of raw or processed meat or idue is the logarithmic transformation poultry products for the analytes mois- of the obtained analytical value. ture, protein, fat, and salt. All four (g) Correct chemical residue identifica- analytes must be determined when a tion—Reporting by a laboratory of the food chemistry analysis is conducted, presence and analytical value of a unless otherwise advised by the ALP. chemical residue that was included in the ALP check sample above the min- (j) Individual large deviation—An ana- imum reporting level. Failure of a lab- lytical result that differs from the oratory to report the presence of such sample comparison mean by more than a chemical residue is considered a would be expected assuming normal misidentification. In addition, report- laboratory variability. ing the presence of and analytical (k) Initial accreditation check sample— value for a residue that was not in- A sample provided by the ALP to a cluded in the ALP check sample above non-Federal laboratory to determine the minimum reporting level is consid- whether the laboratory’s analytical ca- ered a misidentification. pability meets the standards for grant- (h) CUSUM—A class of statistical ing accreditation. procedures for assessing whether or not (l) Inter-laboratory accreditation main- a process is ‘‘in control.’’ Each CUSUM tenance check sample—A sample pro- value is constructed by accumulating vided by FSIS to an accredited labora- incremental values obtained from ob- tory to assist in determining whether served results of the process, and then the laboratory is maintaining accept- determined to either exceed or fall able levels of analytical capability. within acceptable limits for that proc- (m) Large deviation measure—A meas- ess. The initial CUSUM values for each ure that quantifies an unacceptably laboratory whose application for ac- large difference between a laboratory’s creditation is accepted are set at zero. analytical result and the sample com- The CUSUM values are reset to zero at parison mean. the beginning of each year; that is, the (n) Minimum proficiency level (MPL)— CUSUM values associated with the The minimum concentration of a res- first maintenance check sample each idue at which an analytical result will year are set equal to the CUSUM incre- be used to assess a laboratory’s quan- ment for that sample. The four CUSUM tification capability. This concentra- procedures are: tion is an estimate of the smallest con- (1) Positive systematic laboratory centration for which the average coef- difference CUSUM (CUSUM–P)—mon- ficient of variation (CV) for reproduc- itors how consistently an accredited ibility (i.e., combined within and be- laboratory gets numerically greater re- tween laboratory variability) does not sults than the comparison mean; exceed 20 percent.

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(o) Minimum reporting level (MRL)— is applying for accreditation is denied The number such that if any obtained the accreditation. analytical value for a residue in a (w) Responsibly connected—Any indi- check sample or official sample equals vidual, or entity, that is a partner, offi- or exceeds this number, then the res- cer, director, manager, or owner of 10 idue is reported together with the ob- percent or more of the voting stock of tained analytical value. the applicant or recipient of accredita- (p) Official sample—A sample selected tion or an employee in a managerial or by an inspector or inspection service executive capacity or any employee employee in accordance with FSIS pro- who conducts or supervises the chem- cedures for regulatory use. ical analysis of FSIS official samples. (q) Probation—The period com- (x) Revocation of accreditation—An ac- mencing with official notification to tion taken by FSIS against a labora- an accredited laboratory that its check tory, removing the laboratory’s right sample results no longer satisfy the to analyze official samples. performance requirements specified in (y) Standardizing constant—A number this rule, and ending with official noti- that results from a mathematical ad- fication that accreditation either is justment to the ‘‘standardizing value’’ fully restored, is suspended, or is re- and is used to compute the standard- voked. (r) QA (See Quality assurance recov- ized difference for a check sample re- ery). sult. The number takes into consider- (s) QC (See Quality control recovery). ation the expected variance of the dif- (t) Quality assurance (QA) recovery— ference between the accredited or ap- The ratio of a laboratory’s analytical plying laboratory’s result(s) and the value for a check sample residue to the comparison mean for a sample, the established level of the analyte in the standardizing value, the correlation check sample, multiplied by 100. As and number of repeated results by a dictated by the procedures for the laboratory on a sample, and the num- analyte, the analytical value may be ber of laboratories that analyzed a adjusted prior to the recovery com- sample. putation. (z) Standardized difference—The (u) Quality control (QC) recovery—The quotient of the difference between a ratio of a laboratory’s analytical value laboratory’s result on a sample and the of a quality control standard to the es- comparison mean of the sample divided tablished level of the analyte in the by the standardizing constant. standard, multiplied by 100. As dictated (aa) Standardizing value—A number by the procedures for the analyte, the representing the performance standard analytical value may be adjusted prior deviation of an individual result. The to the recovery computation. number is given, or computed by, the (v) Refusal of accreditation—An action information provided in Tables 1 and 2 taken by FSIS when a laboratory that to this paragraph (aa).

TABLE 1 TO PARAGRAPH (aa)—STANDARDIZING VALUES FOR FOOD CHEMISTRY [By product class and analyte]

Fat 1 Salt 1 Product/class Moisture Protein 1 <12.5% ≥12.5% <1% 1–4% ≥4% 2

Cured Pork/ Canned Ham ..... 0.50 0.060 (X 0.65) 0.26 (X 0.25) 0.30 (X 0.25) 0.127 0.127 (X 0.25) 0.22 Ground Beef ...... 0.71 0.060 (X 0.65) N/A 0.35 (X 0.25) 0.127 0.127 (X 0.25) 0.22 Other Meat Prod- ucts ...... 0.57 0.060 (X 0.65) 0.26 (X 0.25) 0.30 (X 0.25) 0.127 0.127 (X 0.25) 0.22 Poultry Products .... 0.57 0.060 (X 0.65) 0.26 (X 0.25) 0.30 (X 0.25) 0.127 0.127 (X 0.25) 0.22

1 The standardizing value is either the value given in the table or is computed by the formula set forth in the table, where X is the comparison mean of the sample. Standardizing values are provided for different percentages of fat and salt as indicated in the table. 2 For dry salami and pepperoni products.

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TABLE 2 TO PARAGRAPH (aa)—STANDARDIZING the ALP or may be submitted elec- VALUES FOR CHEMICAL RESIDUES tronically when so provided for by FSIS. The application shall specify the Class of residues Standard- izing value 3 kinds of accreditation that are wanted by the owner or manager of the labora- Chlorinated Hydrocarbons: 1 tory. A laboratory whose accreditation Aldrin ...... 0.20 Benzene Hexachloride ...... 0.20 has been refused or revoked may re- Chlordane ...... 0.20 apply for accreditation after 60 days Dieldrin ...... 0.20 from the effective date of that action, DDT ...... 0.20 DDE ...... 0.20 and must provide written documenta- TDE ...... 0.20 tion specifying what corrections were Endrin ...... 0.20 made. Heptachlor ...... 0.20 Heptachlor Epoxide ...... 0.20 (b) At the time that an Application Lindane ...... 0.20 for Accreditation is filed with the ALP, Methoxychlor ...... 0.20 the management of a laboratory shall, Toxaphene ...... 0.20 for each accreditation sought, submit a Hexachlorobenzene ...... 0.20 Mirex ...... 0.20 check, bank draft, or money order in Nonachlor ...... 0.20 the amount specified in 9 CFR 391.5, Polychlorinated Biphenyls: 0.20 made payable to the U.S. Department Arsenic 2 ...... 0.25 Sulfonamides 2 ...... 0.25 of Agriculture, along with the com- Volatile Nitrosamine 2 ...... 0.25 pleted application for the accredita- 1 Laboratory statistics are computed over all results (exclud- tion(s). When so provided for by FSIS, ing PCB results), and for specific chemical residues. electronic transfer of funds may be ac- 2 Laboratory statistics are only computed for specific chemical residues. cepted. 3 The standardizing value of all initial accreditation and pro- (c) Accreditation will not be granted bationary check samples computations is 0.15. or continued, without further proce- (bb) Suspension of accreditation—Ac- dure, for failure to pay the accreditation taken by FSIS against a labora- tion fee(s). The fee(s) paid will be non- tory that temporarily removes the lab- refundable and will be credited to the oratory’s right to analyze official sam- account from which the expenses of the ples. Suspension of accreditation ends laboratory accreditation program are when accreditation either is fully re- paid. stored or is revoked. (d) Annually on the anniversary date (cc) Systematic laboratory difference— of each accreditation, FSIS will issue a A comparison of one laboratory’s re- bill in the amount specified in 9 CFR sults with the comparison mean for 391.5 for each accreditation held. Bills samples that show, on average, a con- are payable upon receipt by check, sistent relationship. A laboratory that bank draft, or money order made pay- is reporting, on average, numerically able to the U.S. Department of Agri- greater results than the comparison culture and become delinquent 30 days mean has a positive systematic labora- from the date of the bill. tory difference. Conversely, numeri- (e) Accreditation will be terminated cally smaller results indicate a nega- without further procedure for having a tive systematic laboratory difference. delinquent account. The fee(s) paid will (dd) Variability—Random fluctuations be nonrefundable and will be credited in a laboratory’s processes that cause to the account from which the expenses its analytical results to deviate from a of the ALP are paid. true value. (ee) Variance—The expected average § 439.10 Criteria for obtaining accredi- of the squared differences of sample re- tation. sults from an expected sample mean. (a) Analytical laboratories may be accredited for the analyses of food § 439.5 Applications for accreditation. chemistry analytes, as defined in § 439.1 (a) Application for accreditation of this part, or a specific chemical res- shall be made on designated paper or idue or a class of chemical residues in electronic forms provided by FSIS, or raw or processed meat and poultry otherwise in writing, by the owner or products. manager of a non-Federal analytical (b) Accreditation will be given only if laboratory. The forms shall be sent to the applying laboratory successfully

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satisfies the requirements presented means at or above the logarithm of the below. For food chemistry accredita- minimum proficiency level are avail- tion, the requirements must be satis- able.] fied for all four analytes. (3) Round all check sample statis- (c) This accreditation authorizes offi- tical computations to the nearest cial FSIS acceptance of the analytical tenth, except where otherwise noted. test results provided by these labora- (4) Complete a second set of the req- tories on official samples. uisite number of check samples if the (d) To obtain FSIS accreditation, an results of the first set of check samples analytical laboratory must: do not meet the criteria for obtaining (1) Be supervised by a person holding, accreditation. at a minimum, a bachelor’s degree in (i) The second set of check samples chemistry, food science, food tech- will be provided within 30 days fol- nology, or a related field. lowing the date of receipt by FSIS of a (i) For food chemistry accreditation, request from the applying laboratory. the supervisor must also have one The second set of food chemistry check year’s experience in food chemistry samples will be analyzed for only the analysis, or equivalent qualifications, analyte(s) for which unacceptable ini- as determined by the Administrator. tial results had been obtained by the (ii) For chemical residue accredita- laboratory. tion, either the supervisor or the ana- (ii) If the results of the second set of lyst assigned to analyze the sample check samples do not meet the criteria must also have three years’ experience for obtaining accreditation, the labora- determining analytes at or below part tory may reapply after a 60-day wait- per million levels, or equivalent quali- ing period, commencing from the date fications, as determined by the Admin- of refusal of accreditation by FSIS. At istrator. that time, a new application, all fees, (2) Demonstrate an ability to achieve and all documentation of corrective ac- quality assurance levels that are with- tion required for accreditation must be in acceptable limits for systemic lab- submitted. oratory difference, variability, and in- (5) Allow inspection of the laboratory dividual large deviations, in the by FSIS officials prior to the deter- analyte category for which accredita- mination of granting accredited status. tion is sought, using analytical proce- (6) Pay the accreditation fee by the dures designated by the FSIS ALP as date required. being acceptable. An applying laboratory will successfully demonstrate (e) Quality assurance levels—(1) Sys- these capabilities for: tematic laboratory difference: The abso- (i) Food chemistry if its results from lute value of the average standardized a 36 check sample accreditation study difference must not exceed the fol- each satisfy the criteria presented in lowing: paragraph (e) of this section. (i) For food chemistry, 0.73 minus the (ii) Chemical residues if its analyt- product of 0.17 and the standard devi- ical results for each specific chemical ation of the standardized differences; residue provided in a check sample ac- and creditation study containing a min- (ii) For chemical residues, 1.67 (2.00 if imum of 14 check samples satisfy the there are less than 12 analytical re- criteria presented in paragraph (e) of sults) minus the product of 0.29 and the this section, including criteria for QA standard deviation of the standardized and QC recovery and for residue identi- differences. fication. In addition, if the laboratory (2) Variability: The estimated stand- is requesting accreditation for the ard deviation of the standardized dif- analysis of chlorinated hydrocarbons, ference must not exceed the following: all analytical results for the residue (i) For food chemistry, 1.15; and class must collectively satisfy the cri- (ii) For chemical residues, a com- teria. [Conformance to criteria in para- puted limit that is a function of the graph (e) of this section will only be de- number of analytical results used in termined when six or more analytical the computation of the standard devi- results with associated comparison ation, and of the amount of variability.

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(3) Individual large deviations: One Supporting documentation must be hundred times the average of the large made available to FSIS upon request. deviation measures of the individual (c) Records. An accredited laboratory samples must be less than 5.0. A result must: will have a large deviation measure (1) Maintain laboratory quality con- equal to zero when the absolute value trol records for the most recent three of the result’s standardized difference, years that samples have been analyzed (d), is less than 2.5 and otherwise a under this Program. measure equal to 1–(2.5/d). (2) Maintain complete records of the (4) For residue analyses, the fol- receipt, analysis, and disposition of of- lowing additional quality assurance re- ficial samples for the most recent three quirements must be met. years that samples have been analyzed (i) QA recovery: The average of the under this Program. QA recoveries of the individual check (3) Maintain in a secure electronic sample analytical results must lie format or in a standards book, which is within ranges established by FSIS. preferably a permanently bound book (ii) QC recovery: All QC recoveries with sequentially numbered pages, all must lie within ranges established by records, readings, and calculations for FSIS. Supporting documentation must standard solutions. All entries are to be made available to FSIS upon re- be dated and signed by the analyst im- quest. mediately upon completion of the (iii) Correct identification: There must entry, and by the supervisor, or in the be correct identification of all chem- absence of the supervisor by the super- ical residues in all samples. visor’s designee, before use of the standard solution but no later than § 439.20 Criteria for maintaining ac- within one week. The standards book is creditation. to be retained for three years after the (a) To maintain accreditation, an an- last recorded entry. alytical laboratory must fulfill the re- (4) Maintain records and supervisor quirements of paragraphs (b) through approvals of recoveries, and of instru- (i) of this section. ment maintenance and calibration. The (b) Official samples. (1) An accredited records are to be retained for three laboratory must expeditiously report years after the last recorded entry. analytical results, in the analyte cat- (5) As provided in paragraph (f) of egory for which accreditation was this section, records should be avail- granted, of official samples on des- able for review by any duly authorized ignated forms to the Data Center Staff, representative of the Secretary of Agri- USDA/FSIS Eastern Laboratory, Rus- culture, including ALP personnel or sell Research Center, P.O. Box 6085, their designees. Athens, GA 30604 (for U.S. Postal Serv- (d) Check samples. (1) An accredited ice delivery), or Data Center Staff, laboratory must analyze interlabora- USDA/FSIS Eastern Laboratory, Rus- tory accreditation maintenance check sell Research Center, 950 College Sta- samples and return the results to FSIS tion Road, Athens, GA 30605 (for com- within three weeks of sample receipt. mercial carrier delivery). When so pro- This must be done whenever requested vided for by FSIS, analytical results by FSIS and at no cost to FSIS. may be reported to the Data Center (2) Results must be those of the ac- Staff by facsimile at (706) 546–3589, or credited laboratory. Analyses of main- electronically. The Federal inspector tenance check samples shall not be at any establishment may assign the contracted out by the accredited lab- analysis of official samples to an FSIS oratory. laboratory if, in the inspector’s judg- (3) As provided by the requirements ment, there are delays in receiving test in paragraph (h) of this section, a results on official samples from an ac- check sample report will be considered credited laboratory. complete only if laboratories report all (2) Every QC recovery associated analytes present in the check sample with reporting of official samples must for the analyte category in which ac- lie within ranges established by FSIS. creditation was granted.

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(e) Corporate changes. The ALP must check sample is used to determine two be informed within 30 days of any CUSUM values, designated as CUSUM– change of address or in the laboratory’s P and CUSUM–N. ownership, officers, directors, super- (i) When determining compliance visory personnel, or other responsibly with this criterion for all chlorinated connected individual or entity. hydrocarbon results in a sample collec- (f) On-site review. An accredited lab- tively, the following statistical proce- oratory must permit any duly author- dure must be followed to account for ized representative of the Secretary to the correlation of analytical results perform both announced and unan- within a sample: The average of the nounced on-site laboratory reviews of standardized differences of the analyt- facilities and records, both hard copy ical results within the sample, divided and electronic, during normal business by a constant, is used in place of a sin- hours, and to copy any records per- gle standardized difference to deter- taining to the laboratory’s participa- mine the CUSUM–P (or CUSUM–N) tion in the ALP. value for the sample. The constant is a (g) Analytical procedures. An accred- function of the number of analytical ited laboratory must use analytical results used to compute the average procedures designated by the FSIS standardized difference. ALP as being acceptable. (ii) Positive systematic laboratory (h) Quality assurance levels. (1) An ac- difference: This value is computed and credited laboratory must demonstrate evaluated as follows: an ability to maintain quality assur- (A) Determine the CUSUM–P incre- ance levels that are within acceptable ment for the sample. limits for systematic laboratory dif- (1) The CUSUM–P increment for food ference, variability, and individual chemistry, as defined in § 439.1 of this large deviations in the analysis of part, is set equal to: interlaboratory check samples for the 2.0, if the standardized difference is analyte category for which accredita- greater than 2.4, tion was granted. An accredited labora- ¥2.0, if the standardized difference is tory will successfully demonstrate the less than ¥1.6, or maintenance of these capabilities if its the standardized difference minus 0.4, analytical results from interlaboratory if the standardized difference lies be- accreditation maintenance check sam- tween ¥1.6 and 2.4, inclusive. ples satisfy the criteria presented in (2) The CUSUM–P increment for this paragraph (h). All statistical com- chemical residues is set equal to: putations are to be rounded to the 2.0, if the standardized difference is nearest tenth, except where otherwise greater than 2.5, noted. ¥2.0, if the standardized difference is (2) In addition, a laboratory accred- less than ¥1.5, or ited for a specific chemical residue or a the standardized difference minus 0.5, chemical residue class: if the standardized difference lies be- (i) Must satisfy criteria presented in tween ¥1.5 and 2.5, inclusive. this paragraph for chemical residue re- (B) Compute the new CUSUM–P coveries and proper identification; value. The new CUSUM–P value is ob- (ii) Must demonstrate the mainte- tained by adding, algebraically, the nance of its capabilities by reporting CUSUM–P increment to the last pre- its analytical results for each specific viously computed CUSUM–P value. If chemical residue found above the min- this computation yields a value small- imum proficiency level; and er than 0, the new CUSUM–P value is (iii) Must, if accredited for the anal- set equal to 0. ysis of chlorinated hydrocarbons, ob- (C) Evaluate the new CUSUM–P tain analytical results that collec- value. The new CUSUM–P value must tively satisfy the criteria. not exceed: (3) Systematic laboratory difference: (1) 5.2 for food chemistry. The standardized difference between (2) 4.8 for chemical residues. the accredited laboratory’s result and (iii) Negative systematic laboratory the comparison mean for each interlab- difference: This value is computed and oratory accreditation maintenance evaluated as follows:

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(A) Determine the CUSUM–N incre- (ii) The variability value is computed ment for the sample. and designated as follows: (1) The CUSUM–N increment for food (A) Determine the CUSUM–V incre- chemistry is set equal to: ment for the sample. The CUSUM in- 2.0, if the standardized difference is crement is set equal to the larger of greater than 1.6, ¥0.4 or the absolute value of the stand- ¥2.0, if the standardized difference is ardized difference minus 0.9. If this less than ¥2.4, or computation yields a value larger than the standardized difference plus 0.4, if 1.6, the increment is set equal to 1.6. the standardized difference lies be- (B) Compute the new CUSUM–V tween ¥2.4 and 1.6, inclusive. value. The new CUSUM–V value is ob- (2) The CUSUM–N increment for tained by adding, algebraically, the chemical residues is set equal to: CUSUM–V increment to the last previously computed CUSUM–V value. If 2.0, if the standardized difference is this computation yields a value less greater than 1.5, than 0, the new CUSUM–V value is set ¥2.0, if the standardized difference is equal to 0. less than ¥2.5, or (C) Evaluate the new CUSUM–V the standardized difference plus 0.5, if value. The new CUSUM–V value must the standardized difference lies be- not exceed 4.3. ¥ tween 2.5 and 1.5, inclusive. (5) Large deviations: The large devi- (B) Compute the new CUSUM–N ation measure of the accredited labora- value. The new CUSUM–N value is ob- tory’s result for each interlaboratory tained by subtracting, algebraically, accreditation maintenance check sam- the CUSUM–N increment from the last ple is used to determine a CUSUM previously computed CUSUM–N value. value, designated as CUSUM–D. If this computation yields a value (i) A result will have a large devi- smaller than 0, the new CUSUM–N ation measure equal to zero when the value is set equal to 0. absolute value of the result’s standard- (C) Evaluate the new CUSUM–N ized difference, (d), is less than 2.5, and value. The new CUSUM–N value must otherwise a measure equal to 1¥(2.5/d). not exceed: (ii) The large deviation value is com- (1) 5.2 for food chemistry. puted and evaluated as follows: (2) 4.8 for chemical residues. (A) Determine the CUSUM–D incre- (4) Variability: The absolute value of ment for the sample. The CUSUM in- the standardized difference between crement is set equal to the value of the the accredited laboratory’s result and large deviation measure minus 0.025. the comparison mean for each interlab- (B) Compute the new CUSUM–D oratory accreditation maintenance value. The new CUSUM–D value is ob- check sample is used to determine a tained by adding, algebraically, the CUSUM value, designated as CUSUM– CUSUM–D increment to the last pre- V. viously computed CUSUM–D value. If (i) When determining compliance this computation yields a value less with this criterion for all chlorinated than 0, the new CUSUM–D value is set hydrocarbon results in a sample collec- equal to 0. tively, the following statistical proce- (C) Evaluate the new CUSUM–D dure must be followed to account for value. The new CUSUM–D value must the correlation of analytical results not exceed 1.0. within a sample: The square root of the (6) For chemical residues: sum of the within sample variance and (i) Each QC recovery must lie within the average standardized difference of ranges established by FSIS. the sample, divided by a constant, is Supporting documentation must be used in place of the absolute value of made available to FSIS upon request. the standardized difference to deter- (ii) Not more than one residue mine the CUSUM–V value for the sam- misidentification may be made in any ple. The constant is a function of the two consecutive check samples. number of analytical results used to (iii) Not more than two residue compute the average standardized dif- misidentifications may be made in any ference. eight consecutive check samples.

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(i) Fees. An accredited laboratory (3) Any misdemeanor based upon a must pay the required accreditation fee false statement to any governmental when it is due. agency. (j) Probation. An accredited labora- (4) Any misdemeanor based upon the tory must meet the following require- offering, giving or receiving of a bribe ments if placed on probation pursuant or unlawful gratuity. to § 439.51 of this part: (1) Send all official samples that have § 439.51 Probation of accreditation. not been analyzed as of the date of Upon a determination by the Admin- written notification of probation to a istrator, a laboratory will be placed on specified FSIS laboratory by certified probation for the following reasons: mail or private carrier or, as an alter- (a) If the laboratory fails to complete native and as directed by FSIS, to a more than one interlaboratory accredi- laboratory accredited by FSIS for the tation maintenance check sample anal- designated analyte(s). Mailing expenses ysis as required by § 439.20(d) of this will be paid by FSIS. part within 12 consecutive months, un- (2) Analyze a set of check samples less written permission is granted by similar to those used for initial accred- the Administrator. itation, and submit the analytical re- (b) If the laboratory fails to meet any sults to FSIS within three weeks of re- of the criteria set forth in §§ 439.20(d) ceipt of the samples. and 439.20(h) of this part. (3) Satisfy criteria for accreditation § 439.52 Suspension of accreditation. check samples specified in § 439.10 of this part. The accreditation of a laboratory will be suspended if the laboratory or § 439.50 Refusal of accreditation. any individual or entity responsibly connected with the laboratory is in- Upon a determination by the Admin- dicted or has charges on information istrator, a laboratory will be refused brought against them in a Federal or accreditation for the following reasons: State court for any of the following (a) A laboratory will be refused ac- violations of law: creditation for failure to meet the re- (a) Any felony. quirements of § 439.5 or § 439.10 of this (b) Any misdemeanor based upon ac- part. quiring, handling, or distributing of (b) A laboratory will be refused sub- unwholesome, misbranded, or decep- sequent accreditation for failure to re- tively packaged food or upon fraud in turn to an FSIS laboratory, by cer- connection with transactions in food. tified mail or private carrier, or, as an (c) Any misdemeanor based upon a alternative and as directed by FSIS, to false statement to any governmental a laboratory accredited by FSIS for the agency. designated analytes, all official sam- (d) Any misdemeanor based upon the ples that have not been analyzed as of offering, giving or receiving of a bribe the notification of a loss of accredita- or unlawful gratuity. tion. (c) A laboratory will be refused ac- § 439.53 Revocation of accreditation. creditation if the laboratory or any in- The accreditation of a laboratory dividual or entity responsibly con- will be revoked for the following rea- nected with the laboratory has been sons: convicted of, or is under indictment (a) An accredited laboratory that is for, or has charges on an information accredited to perform analysis under brought against them in a Federal or §§ 439.5, 439.10 and 439.20 of this part will State court concerning any of the fol- have its accreditation revoked for fail- lowing violations of law: ure to meet any of the requirements of (1) Any felony. § 439.20 of this part, except for the fol- (2) Any misdemeanor based upon ac- lowing circumstances. If the accredited quiring, handling, or distributing of laboratory fails to meet any of the cri- unwholesome, misbranded, or decep- teria set forth in §§ 439.20(d) and tively packaged food or upon fraud in 439.20(h) of this part and it has not connection with transactions in food. failed during the 12 months preceding

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its failure to meet the criteria, it shall sion, or revocation will be effective be placed on probation, but if it has upon the receipt by the laboratory of failed at any time during those 12 the notification and will continue in months, its accreditation will be re- effect until final determination of the voked. matter by the Administrator. (b) An accredited laboratory will have its accreditation revoked if the PART 441—CONSUMER PROTEC- Administrator determines that the laboratory or any responsibly connected TION STANDARDS: RAW PROD- individual or any agent or employee UCTS has: (1) Altered any official sample or an- AUTHORITY: 21 U.S.C. 451–470, 601–695; 7 alytical finding; or U.S.C. 450, 1901–1906; 7 CFR 2.18, 2.53. (2) Substituted any analytical result SOURCE: 66 FR 1771, Jan. 9, 2001, unless oth- from any other laboratory and rep- erwise noted. resented the result as its own. (c) An accredited laboratory will § 441.10 Retained water. have its accreditation revoked if the laboratory or any individual or entity (a) Raw livestock and poultry car- responsibly connected with the labora- casses and parts will not be permitted tory is convicted in a Federal or State to retain water resulting from post- court of any of the following violations evisceration processing unless the es- of law: tablishment preparing those carcasses (a) Any felony. and parts demonstrates to FSIS, with (b) Any misdemeanor based upon ac- data collected in accordance with a quiring, handling, or distributing of written protocol, that any water re- unwholesome, misbranded, or decep- tained in the carcasses or parts is an tively packaged food or upon fraud in unavoidable consequence of the process connection with transactions in food. used to meet applicable food safety re- (c) Any misdemeanor based upon a quirements. false statement to any governmental (b) Raw livestock and poultry car- agency. casses and parts that retain water from (d) Any misdemeanor based upon the post-evisceration processing and that offering, giving or receiving of a bribe are sold, transported, offered for sale or or unlawful gratuity. transportation, or received for transportation, in commerce, must bear a § 439.60 Notification and hearings. statement on the label in prominent Accreditation of any laboratory will letters and contiguous to the product be refused, suspended, or revoked under name or elsewhere on the principal dis- the conditions previously described in play panel of the label stating the max- this Part 439. The owner or operator of imum percentage of water that may be the laboratory will be sent written no- retained (e.g., ‘‘up to X% retained tice of the refusal, suspension, or rev- water,’’ ‘‘less than X% retained water,’’ ocation of accreditation by the Admin- ‘‘up to X% water added from proc- istrator. In such cases, the laboratory essing’’). The percent water statement owner or operator will be provided an need not accompany the product name opportunity to present, within 30 days on other parts of the label. Raw live- of the date of the notification, a state- stock and poultry carcasses and parts ment challenging the merits or valid- that retain no water may bear a state- ity of such action and to request an ment that no water is retained. oral hearing with respect to the denial, (c)(1) An establishment subject to suspension, or revocation decision. An paragraph (a) of this section must oral hearing will be granted if there is maintain on file and available to FSIS any dispute of material fact joined in its written data-collection protocol. such responsive statement. The pro- The protocol must explain how data ceeding will be conducted thereafter in will be collected and used to dem- accordance with the applicable rules of onstrate the amount of retained water practice, which will be adopted for the in the product covered by the protocol proceeding. Any such refusal, suspen- that is an unavoidable consequence of

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the process used to meet specified food time allowed for dripping. Any special safety requirements. apparatus, such as a mechanism for (2) The establishment must notify squeezing excessive water from chilled FSIS as soon as it has a new or revised birds, should be explained. protocol available for review by the (5) Description of variable factors in the Agency. Within 30 days after receipt of chilling system. The protocol should de- this notification, FSIS may object to scribe variable factors that affect or require the establishment to make water absorption and retention. In changes in the protocol. poultry processing, such factors are (d) Expected elements of a protocol typically considered to be the time in for gathering water retention data: chiller water, the water temperature, (1) Purpose statement. The primary and agitation. The protocol should con- purpose of the protocol should be to de- sider air agitation, where applicable. termine the amount or percentage of Additional factors that may affect water absorption and retention that is water absorption and retention are unavoidable using a particular chilling scalding temperature and the pressure system while achieving the regulatory or amount of buffeting applied to birds pathogen reduction performance stand- by feather removal machinery, and the ard for Salmonella as set forth in the resultant loosening of the skin. An- PR/HACCP regulations (9 CFR 310.25(b), other factor that should be considered 381.94(b)) and the time/temperature re- is the method used to open the bird for quirements set forth in 9 CFR 381.66. evisceration. Additional purposes that could be in- (6) Standards to be met by the chilling cluded are determining chilling system system. For example, the chilling sys- efficiency and evaluating product qual- tem may be designed simply to achieve ity. a reduction in temperature of ready-to- (2) Type of washing and chilling system cook poultry to less than 40 °F within used by the establishment. Any post-evis- the time limit specified by the regula- ceration washing or chilling processes tions, or in less time. As to the stand- that affect water retention levels in ard for pathogen minimization, the Sal- and microbial loads on raw products monella pathogen reduction standards, should be described. For poultry estab- as set forth in the PR/HACCP final lishments, the main chiller types, iden- rule, have been suggested. Although tified by the mechanism used to trans- there is not yet an applicable Sal- port the birds through the chiller or to monella standard for turkeys, establish- agitate the water in the chiller, are the ments are free to adopt practicable cri- drag-through, the screw type, and the teria for use in gathering data on tur- rocker-arm type. keys under the protocols here sug- (3) Configuration and any modifications gested. Additional microbiological tar- of the chiller system components. A de- gets, such as E. coli or Campylobacter scription of chiller-system configura- levels, or reductions in numbers of tions and modifications should be pro- other microorganisms, may also be vided. The description should include used. the number and type of chillers in a se- (7) Testing methods to be employed. The ries and arrangements of chilling sys- protocol should detail the testing tem components, and the number of methods to be used both for measuring evisceration lines feeding into a chiller water absorption and retention and for system. If there is a pre-chilling step in sampling and testing product for the process, its purpose and the type of pathogen reductions. The protocol equipment used should be accurately should call for water retention and described. Any mechanical or design pathogen reduction tests at various changes made to the chilling equip- chilling equipment settings and ment should be described. chilling time-and-temperature com- (4) Special features in the chilling proc- binations. The method to be used in ess. Any special features in the chilling calculating water absorption and reprocess, such as antimicrobial treat- tention should be reproducible and sta- ments, should be described. Also, the tistically verifiable. With respect to length and velocity of the dripping line the pathogen-reduction aspect of the should be described, as well as the total testing, FSIS recommends the methods

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used for E. coli and Salmonella testing porated by reference. The Director of under the PR/HACCP regulations. The the Federal Register approves this in- number of samples, the type of sam- corporation by reference in accordance ples, the sampling time period, and the with 5 U.S.C. 552(a) and 1 CFR part 51. type of testing or measurement should Copies of NIST Handbook 133 may be be included in the protocol. purchased from the Superintendent of (8) Reporting of data and evaluation of Documents, U.S. Government Printing results. The protocol should explain Office, 732 N. Capitol Street, NW., how data obtained are to be reported Washington, DC, 20401. You may con- and summarized. The criteria for eval- tact the Government Printing Office uating the results and the basis for Toll-Free at 1–866–512–1800 or go to: conclusions to be drawn should be ex- http://bookstore.gpo.gov. You may in- plained. spect a copy of NIST Handbook 133 at (9) Conclusions. The protocol should the FSIS Docket Room, U.S. Depart- provide for a statement of what the ment of Agriculture, Food Safety and data obtained demonstrate and what Inspection Service, 1400 Independence conclusions were reached. Avenue, SW., Room 2534, Washington, DC 20250. You can contact the FSIS PART 442—QUANTITY OF CON- Docket room by calling 202–720–0344 or TENTS LABELING AND PROCE- 202–720–3813. The NIST Handbook 133 is DURES AND REQUIREMENTS FOR also available for inspection at the Na- tional Archives and Records Adminis- ACCURATE WEIGHTS tration (NARA). For information on the availability of this material at Sec. 442.1 Quantity of contents labeling NARA, call 202–741–6030, or go to:http:// 442.2 Definitions and procedures for deter- www.archives.gov/federallregister/ mining net weight compliance codeloflfederallregulations/ 442.3 Scale requirements for accurate ibrllocations.html. weights, repairs, adjustments, and re- (b) The following NIST Handbook 133 placement after inspection requirements are not incorporated by 442.4 Testing of scales reference. 442.5 Handling of failed product

AUTHORITY: 21 U.S.C. 451–470, 601–695; 7 CFR CHAPTER 2—BASIC TEST PROCEDURE— 2.18, 2.53. GRAVIMETRIC TESTING

SOURCE: 73 FR 52192, Sept. 9, 2008, unless 2.3 Basic Test Procedure—Tare Proce- otherwise noted. dures—Wet Tare 2.3 Basic Test Procedure—Moisture Al- § 442.1 Quantity of contents labeling. lowances—What moisture allowance is used with wet tare when testing packages bearing a This part prescribes the procedures USDA seal of inspection? to be followed for determining net 2.4 Borax weight compliance and prescribes the reasonable variations allowed from the CHAPTER 3—TEST PROCEDURES—FOR declared net weight on the labels of im- PACKAGES LABELED BY VOLUME mediate containers of products in ac- 3.5 Mayonnaise and Salad Dressing cordance with 9 CFR 317.2(c)(4), 3.7 Pressed and Blown Glass Tumblers and 317.2(h), and 381.121. Stemware 3.8 Volumetric Test Procedures for Paint, § 442.2 Definitions and procedures for Varnish, and Lacquers—Non Aerosol determining net weight compliance. 3.9 Testing Viscous Materials—Such as Caulking Compounds and Pasters (a) For the purpose of § 442.1 of this 3.10 Peat Moss part, the reasonable variations al- 3.11 Mulch and Soils Labeled by Volume lowed, and the definitions and the pro- 3.12 Ice Cream Novelties cedures to be used, in determining net 3.13 Fresh Oysters Labeled by Volume weight and net weight compliance are 3.14 Determining the Net Contents of presented in the National Institute of Compressed Gas Cylinders 3.15 Volumetric Test Procedures for Pack- Standards and Technology (NIST) aged Firewood with a Labeled Volume of 133 Handbook 133, ‘‘Checking the Net Con- L (4 Cu Ft) or Less tents of Packaged Goods,’’ Fourth Edi- 3.16 Boxed Firewood tion, January 2005, which is incor- 3.17 Crosshatched Firewood

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3.18 Bundles and Bags of Firewood be of sufficient capacity to weigh the entire unit or package. CHAPTER 4—TEST PROCEDURES—PACKAGES (c) No scale will be used at a feder- LABELED BY COUNT, LINEAR MEASURE, AREA, THICKNESS, AND COMBINATIONS OF ally inspected establishment to deter- QUANTITIES mine the net weight of meat or poultry products unless it has been found upon 4.5 Paper Plates and Sanitary Paper Prod- test and inspection, as specified in ucts 4.6 Special Test Requirements for Pack- NIST Handbook 44 to provide accurate ages Labeled by Linear or Square Measure weight. If a scale is inspected or tested (Area) and found to be inaccurate, or if any 4.7 Polyethylene sheeting repairs, adjustments, or replacements 4.8 Packages Labeled by Linear or Square are made to a scale, it shall not be used (Area) Measure until it has been reinspected and re- 4.9 Bailer Twine—Test Procedure for tested by a USDA official, or a State or Length local government weights and meas- 4.10 Procedure for Checking the Area Measurement of Chamois Appendix C Glos- ures official, or a State registered or li- sary—wet tare censed scale repair firm or person, and it must meet all accuracy require- § 442.3 Scale requirements for accu- ments as specified in NIST Handbook rate weights, repairs, adjustments, 44. If a USDA inspector has put a ’’Re- and replacements after inspection. tain’’ tag on a scale, the tag can only (a) All scales used to determine the be removed by a USDA inspector. As net weight of meat and poultry prod- long as the tag is on the scale, it shall ucts sold or otherwise distributed in not be used. commerce in federally inspected meat and poultry establishments will be in- § 442.4 Testing of scales. stalled, maintained, and operated in a (a) The operator of each official es- manner that ensures accurate weights. tablishment that weighs meat or poul- Such scales shall meet the applicable try food products will cause such scales requirements contained in National In- to be tested for accuracy in accordance stitute of Standards and Technology with the technical requirements of (NIST) Handbook 44, ’’Specifications, NIST Handbook 44, at least once during Tolerances, and Other Technical Re- the calendar year. In cases where the quirements for Weighing and Meas- scales are found not to maintain accu- uring Devices,’’ 1999 Edition, November racy between tests, more frequent tests 1988, which is incorporated by ref- may be required and verified by an au- erence. This incorporation was ap- thorized USDA program official. proved by the Director of the Federal (b) The operator of each official es- Register in accordance with 5 U.S.C. tablishment shall display on or near 552(a) and 1 CFR part 51. (These mate- each scale a valid certification of the rials are incorporated as they exist on scale’s accuracy from a State or local the date of approval.) A notice of any government’s weights and measures change in the Handbook cited here will authority or from a State registered or be published in the FEDERAL REGISTER. licensed scale repair firm or person, or Copies may be purchased from the Su- shall have alternative documented pro- perintendent of Documents, Govern- cedures showing that the scale has ment Printing Office, Washington, DC been tested for accuracy in accordance 20402. The incorporation information with the requirements of NIST Hand- also is available for inspection at the book 44. Office of the Federal Register Informa- tion Center, 800 North Capitol Street, § 442.5 Handling of failed product. NW., suite 700, Washington, DC 20408. Any lot of product that is found to be (b) All scales used to determine the out of compliance with net weight re- net weight of meat or poultry products quirements upon testing in accordance sold or otherwise distributed in com- with the methods prescribed in § 442.2 merce or in States designated under of this subchapter shall be handled as section 301(c) of the Federal Meat In- follows: spection Act and section 5(c) of the (a) A lot tested in an official estab- Poultry Products Inspection Act shall lishment and found not to comply with

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net weight requirements may be re- (1) Insanitary conditions or practices; processed and must be reweighed and (2) Product adulteration or mis- remarked to satisfy the net weight re- branding; quirements of this section in accord- (3) Conditions that preclude FSIS ance with the requirements of this from determining that product is not part. adulterated or misbranded; or (b) A lot tested outside an official es- (4) Inhumane handling or slaugh- tablishment and found not to comply tering of livestock. with net weight requirements must be reweighed and remarked with a proper (b) If a regulatory control action is net weight statement, provided that taken, the program employee will im- such reweighing and remarking will mediately notify the establishment not deface, cover, or destroy any other orally or in writing of the action and marking or labeling required under the basis for the action. this subchapter, and the net quantity (c) An establishment may appeal a of contents is shown with the same regulatory control action, as provided prominence as the most conspicuous in §§ 306.5 and 381.35 of this chapter. feature of a label. § 500.3 Withholding action or suspen- PART 500—RULES OF PRACTICE sion without prior notification. (a) FSIS may take a withholding ac- Sec. tion or impose a suspension without 500.1 Definitions. providing the establishment prior noti- 500.2 Regulatory control action. fication because: 500.3 Withholding or suspension of inspection without prior notification. (1) The establishment produced and 500.4 Withholding action or suspension of shipped adulterated or misbranded inspection with prior notification. product as defined in 21 U.S.C. 453 or 21 500.5 Notification, appeals, and actions held U.S.C. 602; in abeyance. (2) The establishment does not have a 500.6 Withdrawal of inspection. 500.7 Refusal to grant inspection. HACCP plan as specified in § 417.2 of 500.8 Procedures for rescinding or refusing this chapter; approval of marks, labels, sizes, and con- (3) The establishment does not have tainers. Sanitation Standard Operating Proce- AUTHORITY: 21 U.S.C. 451–470, 601–695; 7 dures as specified in §§ 416.11–416.12 of U.S.C. 450, 1901–1906; 7 CFR 2.18, 2.53. this chapter; SOURCE: 64 FR 66546, Nov. 29, 1999, unless (4) Sanitary conditions are such that otherwise noted. products in the establishment are or would be rendered adulterated; § 500.1 Definitions. (5) The establishment violated the (a) A ‘‘regulatory control action’’ is terms of a regulatory control action; the retention of product, rejection of (6) An establishment operator, offi- equipment or facilities, slowing or cer, employee, or agent assaulted, stopping of lines, or refusal to allow threatened to assault, intimidated, or the processing of specifically identified interfered with an FSIS employee; or product. (7) The establishment did not destroy (b) A ‘‘withholding action’’ is the refusal to allow the marks of inspection a condemned meat or poultry carcass, to be applied to products. A with- or part or product thereof, in accord- holding action may affect all product ance with part 314 or part 381, subpart in the establishment or product pro- L, of this chapter within three days of duced by a particular process. notification. (c) A ‘‘suspension’’ is an interruption (b) FSIS also may impose a suspen- in the assignment of program employ- sion without providing the establish- ees to all or part of an establishment. ment prior notification because the establishment is handling or slaugh- § 500.2 Regulatory control action. tering animals inhumanely. (a) FSIS may take a regulatory control action because of:

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§ 500.4 Withholding action or suspen- (3) Identify the products or processes sion with prior notification. affected by the proposed action; FSIS may take a withholding action (4) Advise the establishment of its or impose a suspension after an estab- right to contact FSIS to contest the lishment is provided prior notification basis for the proposed action or to ex- and the opportunity to demonstrate or plain how compliance has been or will achieve compliance because: be achieved; and (5) Advise the establishment that it (a) The HACCP system is inadequate, will have three business days from reas specified in § 417.6 of this chapter, ceipt of the written notification to re- due to multiple or recurring non- spond to FSIS unless the time period is compliances; extended by FSIS. (b) The Sanitation Standard Oper- (c) An establishment may appeal the ating Procedures have not been prop- withholding action or suspension, as erly implemented or maintained as provided in §§ 306.5 and 381.35 of this specified in §§ 416.13 through 416.16 of chapter. this chapter; (d) If FSIS suspends inspection and (c) The establishment has not main- does not hold the suspension action in tained sanitary conditions as pre- abeyance as provided in paragraph (e) scribed in §§ 416.2–416.8 of this chapter of this section, the establishment may due to multiple or recurring non- request a hearing pursuant to the Uni- compliances; form Rules of Practice, 7 CFR Subtitle (d) The establishment did not collect A, part 1, subpart H. Upon such re- and analyze samples for Escherichia coli quest, the Administrator will file a Biotype I and record results in accord- complaint that will include a request ance with § 310.25(a) or § 381.94(a) of this for an expedited hearing. chapter; (e) FSIS may hold a suspension in (e) The establishment did not meet abeyance and allow the establishment the Salmonella performance standard to operate under the conditions agreed requirements prescribed in § 310.25(b) or to by FSIS and the establishment. § 381.94(b) of this chapter. § 500.6 Withdrawal of inspection. § 500.5 Notification, appeals, and actions held in abeyance. The FSIS Administrator may file a complaint to withdraw a grant of Fed- (a) If FSIS takes a withholding ac- eral inspection in accordance with the tion or imposes a suspension, the es- Uniform Rules of Practice, 7 CFR sub- tablishment will be notified orally and, title A, part 1, subpart H because: as promptly as circumstances permit, (a) An establishment produced and in writing. The written notification shipped adulterated product; will: (b) An establishment did not have or (1) State the effective date of the ac- maintain a HACCP plan in accordance tion(s), with part 417 of this chapter; (2) Describe the reasons for the ac- (c) An establishment did not have or tion(s), maintain Sanitation Standard Oper- (3) Identify the products or processes ating Procedures in accordance with affected by the action(s), part 416 of this chapter; (4) Provide the establishment an op- (d) An establishment did not main- portunity to present immediate and tain sanitary conditions; corrective action and further planned (e) An establishment did not collect preventive action; and and analyze samples for Escherichia coli (5) Advise the establishment that it Biotype I and record results as pre- may appeal the action as provided in scribed in § 310.25(a) or § 381.94(a) of this §§ 306.5 and 381.35 of this chapter. chapter; (b) The prior notification provided (f) An establishment did not comply for in § 500.4 of this part will: with the Salmonella performance (1) State the type of action that FSIS standard requirements as prescribed in may take; §§ 310.25(b) and 381.94(b) of this chapter; (2) Describe the reason for the pro- (g) An establishment did not slaugh- posed action; ter or handle livestock humanely;

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(h) An establishment operator, offi- provided the opportunity for a hearing cer, employee, or agent assaulted, in accordance with the Uniform Rules threatened to assault, intimidated, or of Practice, 7 CFR Subtitle A, part 1, interfered with an FSIS program em- subpart H. ployee; or (i) A recipient of inspection or any- § 500.8 Procedures for rescinding or one responsibly connected to the re- refusing approval of marks, labels, cipient is unfit to engage in any busi- and containers. ness requiring inspection as specified (a) FSIS may rescind or refuse ap- in section 401 of the FMIA or section proval of false or misleading marks, la- 18(a) of the PPIA. bels, or sizes or forms of any container for use with any meat or poultry prod- § 500.7 Refusal to grant inspection. uct under section 7 of the FMIA or (a) The FSIS Administrator may under section 8 of the PPIA. refuse to grant Federal inspection be- (b) FSIS will provide written notifi- cause an applicant: cation that: (1) Does not have a HACCP plan as (1) Explains the reason for rescinding required by part 417 of this chapter; or refusing the approval; (2) Does not have Sanitation Stand- ard Operating Procedures as required (2) Provides an opportunity for the by part 416 of this chapter; establishment to modify the marking, (3) Has not demonstrated that ade- labeling, or container so that it will no quate sanitary conditions exist in the longer be false or misleading; and establishment as required by part 308 (3) Advises the establishment of its or part 381, subpart H, and part 416 of opportunity to submit a written state- this chapter; ment to respond to the notification and (4) Has not demonstrated that live- to request a hearing. stock will be handled and slaughtered (c) If FSIS rescinds or refuses ap- humanely; or proval of false or misleading marks, la- (5) Is unfit to engage in any business bels, or sizes or forms of any container requiring inspection as specified in sec- for use with any meat or poultry prod- tion 401 of the FMIA or section 18(a) of uct, an opportunity for a hearing will the PPIA. be provided in accordance with the (b) If the Administrator refuses to Uniform Rules of Practice, 7 CFR sub- grant inspection, the applicant will be title A, part 1, subpart H.

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PART 590—INSPECTION OF EGGS 590.130 Basis of billing plants. 590.132 Access to plants. AND EGG PRODUCTS (EGG 590.134 Accessibility of product and cooler PRODUCTS INSPECTION ACT) rooms. 590.136 Facilities and equipment to be fur- DEFINITIONS nished by official plants for use of inspectors in performing service. Sec. 590.1 Meaning of words. APPLICATION FOR SERVICE 590.5 Terms defined. 590.140 How application shall be made. ADMINISTRATION 590.142 Filing of application. 590.144 Authority of applicant. 590.10 Authority. 590.146 Application for continuous inspec- 590.13 Federal and State cooperation. tion in official plants; approval. 590.17 Nondiscrimination. 590.148 Order of service. 590.18 OMB control numbers assigned pursuant to the Paperwork Reduction Act. INAUGURATION OF SERVICE

SCOPE OF INSPECTION 590.150 Official plant numbers. 590.155 Inauguration of service. 590.20 Inspection in accordance with methods prescribed or approved. DENIAL OF SERVICE 590.22 Basis of service. 590.24 Egg products plants requiring contin- 590.160 Refusal, suspension, or withdrawal uous inspection. of service. 590.26 Egg products entering or prepared in 590.161 Termination of plant approval. official plants. RECORDS AND RELATED REQUIREMENTS FOR 590.28 Other inspections. EGGS AND EGG PRODUCTS HANDLERS AND RELATION TO OTHER AUTHORITIES RELATED INDUSTRIES 590.30 At official plants. 590.200 Records and related requirements. 590.35 Eggs and egg products outside official 590.220 Information and assistance to be fur- plants. nished to inspectors.

EGGS AND EGG PRODUCTS NOT INTENDED FOR ADMINISTRATIVE DETENTION HUMAN FOOD 590.240 Detaining product. 590.40 Continuous inspection not provided. 590.45 Prohibition on eggs and egg products APPEAL OF AN INSPECTION OR DECISION not intended for use as human food. 590.300 Who may request an appeal inspection or review of an inspector’s decision. REFRIGERATION OF SHELL EGGS 590.310 Where to file an appeal. 590.50 Temperature and labeling require- 590.320 How to file an appeal. ments. 590.330 When an application for an appeal inspection may be refused. EXEMPTIONS 590.340 Who shall perform the appeal. 590.100 Specific exemptions. 590.350 Procedures for selecting appeal sam- 590.105 Suspension or termination of exemp- ples. tions. 590.360 Appeal inspection certificates. 590.370 Cost of appeals. PERFORMANCE OF SERVICE CERTIFICATES 590.110 Licensed inspectors. 590.112 Suspension of license or authority; 590.400 Form of certificates. revocation. 590.402 Egg products inspection certificates. 590.114 Surrender of license. 590.404 Erasures or alterations made on offi- 590.116 Activities of inspectors. cial certificates. 590.118 Identification. 590.406 Disposition of official certificates. 590.119 Political activity. IDENTIFYING AND MARKING PRODUCT 590.120 Financial interest of inspectors. 590.122 Time of inspection. 590.410 Shell eggs and egg products required 590.124 Schedule of operation of official to be labeled. plants. 590.411 Requirement of formulas and ap- 590.126 Overtime inspection service. proval of labels for use in official egg 590.128 Holiday inspection service. products plants.

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590.412 Form of official identification sym- 590.575 Heat treatment of dried whites. bol and inspection mark. 590.414 Products bearing the official inspec- LABORATORY tion mark. 590.580 Laboratory tests and analyses. 590.415 Use of other official identification. 590.417 Unauthorized use or disposition of EXEMPTED EGG PRODUCTS PLANTS approved labels. 590.600 Application for exemption. 590.418 Supervision of marking and pack- 590.610 Criteria for exemption. aging. 590.620 Authority of applicant. 590.419 Reuse of containers bearing official 590.630 Filing of application. identification prohibited. 590.640 Application for exemption; approval. 590.650 Exempted plant registration num- INSPECTION, REINSPECTION, CONDEMNATION, ber. AND RETENTION 590.660 Inspection of exempted plants. 590.420 Inspection. 590.670 Termination of exemption. 590.422 Condemnation. 590.680 Approval of labeling for egg products 590.424 Reinspection. processed in exempted egg products proc- 590.426 Retention. essing plants.

ENTRY OF MATERIALS INTO OFFICIAL EGG IDENTIFICATION OF RESTRICTED EGGS OR EGG PRODUCTS PLANTS PRODUCTS NOT INTENDED FOR HUMAN CON- 590.430 Limitation on entry of material. SUMPTION 590.435 Wholesomeness and approval of ma- 590.800 Identification of restricted eggs. terials. 590.840 Identification of inedible, unwhole- 590.440 Processing ova. some, or adulterated egg products. 590.860 Identification wording. SANITARY, PROCESSING, AND FACILITY REQUIREMENTS IMPORTS 590.500 Plant requirements. 590.900 Requirements for importation of egg 590.502 Equipment and utensils; PCB-con- products or restricted eggs into the taining equipment. United States. 590.504 General operating procedures. 590.905 Importation of restricted eggs or 590.506 Candling and transfer-room facili- eggs containing more restricted eggs ties and equipment. than permitted in the official standards 590.508 Candling and transfer-room oper- for U.S. Consumer Grade B. ations. 590.910 Eligibility of foreign countries for 590.510 Classifications of shell eggs used in importation of egg products into the the processing of egg products. United States. 590.515 Egg cleaning operations. 590.915 Foreign inspection certification re- 590.516 Sanitizing and drying of shell eggs quired. prior to breaking. 590.920 Importer to make application for in- 590.520 Breaking room facilities. spection of imported eggs and egg prod- 590.522 Breaking room operations. ucts. 590.530 Liquid egg cooling. 590.925 Inspection of imported egg products. 590.532 Liquid egg holding. 590.930 Imported egg products; retention in 590.534 Freezing facilities. customs custody; delivery under bond; 590.536 Freezing operations. movement prior to inspection; sealing; 590.538 Defrosting facilities. handling; facilities, and assistance. 590.539 Defrosting operations. 590.935 Means of conveyance and equipment 590.540 Spray process drying facilities. used in handling egg products to be 590.542 Spray process drying operations. maintained in sanitary condition. 590.544 Spray process powder; definitions 590.940 Marking of egg products offered for and requirements. importation. 590.546 Albumen flake process drying facili- 590.945 Foreign egg products offered for im- ties. portation; reporting of findings to cus- 590.547 Albumen flake process drying oper- toms; handling of products refused entry. ations. 590.950 Labeling of containers of eggs or egg 590.548 Drying, blending, packaging, and products for importation. heat treatment rooms and facilities. 590.955 Labeling of shipping containers of 590.549 Dried egg storage. eggs or egg products for importation. 590.550 Washing and sanitizing room or area 590.956 Relabeling of imported egg products. facilities. 590.960 Small importations for consignee’s 590.552 Cleaning and sanitizing require- personal use, display, or laboratory anal- ments. ysis. 590.560 Health and hygiene of personnel. 590.965 Returned U.S. inspected and marked 590.570 Pasteurization of liquid eggs. products; not importations.

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590.970 Charges for storage, cartage, and (2) If it is, in whole or in part, a raw labor with respect to products imported agricultural commodity and such com- contrary to the Act. modity bears or contains a pesticide AUTHORITY: 21 U.S.C. 1031–1056. chemical which is unsafe within the meaning of section 408 of the Federal SOURCE: 36 FR 9814, May 28, 1971, unless otherwise noted. Redesignated at 42 FR 32514, Food, Drug, and Cosmetic Act; June 27, 1977 and 46 FR 63203, Dec. 31, 1981. (3) If it bears or contains any food ad- Further redesignated at 63 FR 72353, Dec. 31, ditive which is unsafe within the mean- 1998. ing of section 409 of the Federal Food, Drug, and Cosmetic Act; DEFINITIONS (4) If it bears or contains any color additive which is unsafe within the § 590.1 Meaning of words. meaning of section 706 of the Federal Under these regulations, words in the Food, Drug, and Cosmetic Act: Pro- singular shall be deemed to mean the vided, that an article which is not oth- plural and vice versa, as the case may erwise deemed adulterated under para- demand. graph (b)(2), (3), or (4) of this definition shall nevertheless be deemed adulter- § 590.5 Terms defined. ated if use of the pesticide chemical, food additive, or color additive, in or For the purpose of these regulations, on such article, is prohibited by regula- unless the context otherwise requires, tions of the Secretary in official the following terms shall be construed, plants; respectively, as follows: (c) If it consists in whole or in part of Acceptable means suitable for the pur- any filthy, putrid, or decomposed sub- pose intended and acceptable to the stance, or if it is otherwise unfit for Administrator. human food; Act means the applicable provisions (d) If it has been prepared, packaged, of the Egg Products Inspection Act or held under insanitary conditions (Pub. L. 91–597, 84 Stat. 1620 et seq.). whereby it may have become contami- Administrator means the Adminis- nated with filth, or whereby it may trator of the Agricultural Marketing have been rendered injurious to health; Service of the Department or any other (e) If it is an egg which has been sub- officer or employee of the Department jected to incubation or the product of to whom there has heretofore been del- any egg which has been subjected to in- egated, or to whom there may here- cubation; after be delegated the authority to act (f) If its container is composed, in in his stead. whole or in part of any poisonous or Adulterated means any egg or egg deleterious substance which may product under one or more of the fol- render the contents injurious to lowing circumstances: health; (a) If it bears or contains any poi- (g) If it has been intentionally sub- sonous or deleterious substance which jected to radiation, unless the use of may render it injurious to health; but the radiation was in conformity with a in case the substance is not an added regulation or exemption in effect pur- substance, such article shall not be suant to section 409 of the Federal considered adulterated under this Food, Drug, and Cosmetic Act; or clause if the quantity of such sub- (h) If any valuable constituent has stance in or on such article does not been, in whole or in part, omitted or ordinarily render it injurious to health; abstracted therefrom; or if any sub- (b)(1) If it bears or contains any stance has been substituted, wholly or added poisonous or added deleterious in part therefor; or if damage or inferi- substance (other than one which is (i) a ority has been concealed in any man- pesticide chemical in or on a raw agri- ner; or if any substance has been added cultural commodity; (ii) a food addi- thereto or mixed or packed therewith tive; or (iii) a color additive) which so as to increase its bulk or weight, or may in the judgment of the Secretary, reduce its quality or strength, or make make such article unfit for human it appear better or of greater value food; than it is.

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Ambient temperature means the air (b) Clean and sound shell egg means temperature maintained in an egg stor- any egg whose shell is free of adhering age facility or transport vehicle. dirt or foreign material and is not Applicant means any person who re- cracked or broken. quests any inspection service as au- (c) Dirty egg or Dirties means an thorized under the Act or the regula- egg(s) that has a shell that is unbroken tions of this part. and has adhering dirt, foreign material, Capable of use as human food means or prominent stains. any egg or egg product, unless it is de- (d) Incubator reject means an egg that natured, or otherwise identified, as re- has been subjected to incubation and quired by these regulations to deter its has been removed from incubation dur- use as human food. ing the hatching operations as infertile Chief of the Grading Branch means or otherwise unhatchable. Chief of the Poultry Grading Branch, (e) Inedible means eggs of the fol- Poultry Division, Agricultural Mar- lowing descriptions: Black rots, yellow keting Service. rots, white rots, mixed rots, sour eggs, Class means any subdivision of a eggs with green whites, eggs with product based on essential physical stuck yolks, moldy eggs, musty eggs, characteristics that differentiate be- eggs showing blood rings, and eggs con- tween major groups of the same kind, taining embryo chicks (at or beyond type, or method of processing. the blood ring stage). Commerce means interstate, foreign, (f) Leaker means an egg that has a or intrastate commerce. crack or break in the shell and shell membranes to the extent that the egg Condition means any condition (in- contents are exposed or are exuding or cluding, but not being limited to, the free to exude through the shell. state of preservation, cleanliness, (g) Loss means an egg that is unfit for soundness, wholesomeness, or fitness human food because it is smashed or for human food) of any product which broken so that its contents are leak- affects its merchantability; or any con- ing; or overheated, frozen, or contami- dition, including but not being limited nated; or an incubator reject; or be- to, the processing, handling, or pack- cause it contains a bloody white, large aging which affects such product. meat spots, a large quantity of blood, Container or Package includes for egg or other foreign material. products, any box, can, tin, plastic, or (h) Restricted egg means any check, other receptacle, wrapper, or cover and dirty egg, incubator reject, inedible, for shell eggs, any carton, basket, case, leaker, or loss. cart, pallet, or other receptacle. Egg handler means any person, ex- (a) Immediate container means any cluding the ultimate consumer, who package or other container in which engages in any business in commerce egg products or shell eggs are packed that involves buying or selling any for household or other ultimate con- eggs (as a poultry producer or other- sumers. wise), or processing any egg products, (b) Shipping container means any con- or otherwise using any eggs in the tainer used in packing an immediate preparation of human food. container. Egg product means any dried, frozen, Department means the U.S. Depart- or liquid eggs, with or without added ment of Agriculture. ingredients, excepting products which Dirty egg or Dirties means an egg(s) contain eggs only in a relatively small that has an unbroken shell with adher- proportion or historically have not ing dirt or foreign material. been, in the judgment of the Secretary, Egg means the shell egg of the do- considered by consumers as products of mesticated chicken, turkey, duck, the egg food industry, and which may goose, or guinea. Some of the terms ap- be exempted by the Secretary under plicable to shell eggs are as follows: such conditions as he may prescribe to (a) Check means an egg that has a assure that the egg ingredients are not broken shell or crack in the shell but adulterated and such products are not has its shell membranes intact and represented as egg products. For the contents not leaking. purposes of this part, the following

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products, among others, are exempted Interested party means any person fi- as not being egg products: Freeze-dried nancially interested in a transaction products, imitation egg products, egg involving any inspection or appeal in- substitutes, dietary foods, dried no- spection of any product, or the decision bake custard mixes, egg nog mixes, of an inspector. acidic dressings, noodles, milk and egg Label means a display of any printed, dip, cake mixes, French toast, and graphic, or other method of identifica- sandwiches containing eggs or egg tion upon the shipping container, if products, provided, such products are any, or upon the immediate container, prepared from inspected egg products including but not limited to, an indi- or eggs containing no more restricted vidual consumer package of eggs and eggs than are allowed in the official egg products, or accompanying such standards for U.S. Consumer Grade B product. shell eggs. Balut and other similar eth- Misbranded means any egg products nic delicacies are also exempted from which are not labeled and packaged in inspection under this part. accordance with the requirements pre- Eggs of current production means shell scribed by regulations of the Adminis- eggs which have moved through the trator under this part. usual marketing channels since the National Supervisor means: time they were laid and are not in ex- (a) The officer in charge of the in- cess of 60 days old. spection service; and Fair Packaging and Labeling Act (b) Such other employee of the Serv- means the Act so entitled, approved ice as may be designated by him. November 3, 1966 (80 Stat. 1296), and Nest-run eggs means eggs which are Acts amendatory thereof or supple- packed as they come from the produc- mentary thereto. tion facilities without having been washed, sized and/or candled for qual- Federal Food, Drug, and Cosmetic Act ity, with the exception that some means the Act so entitled, approved checks, dirties, or other obvious under- June 25, 1938 (52 Stat. 1040), and Acts grades may have been removed. amendatory thereof or supplementary Official certificate means any certifi- thereto. cate prescribed by regulations of the Inspection means the application of Administrator for issuance by an in- such inspection methods and tech- spector or other person performing offi- niques as are deemed necessary by the cial functions under this part. responsible Secretary to carry out the Official device means any device pre- provisions of the Egg Products Inspec- scribed or authorized by the Secretary tion Act and the regulations under this for use in applying any official mark. part. Official identification means the offi- Inspection service means the official cial inspection mark or any other sym- service within the Department having bol prescribed by regulations of this the responsibility for carrying out the part to identify the status of any arti- provisions of the Egg Products Inspec- cle. tion Act. Inspection service also means Official inspection mark means any the activities performed, including offi- symbol prescribed by the regulations of cial reporting by such official service. the Administrator showing that egg Inspector/Grader means: products were inspected in accordance (a) Any employee or official of the with this part. United States Government authorized Official standard means the standards to inspect eggs or egg products under of quality, grades, and weight classes the authority of this part; or for eggs. (b) Any employee or official of the Office of inspection means the office of government of any State or local juris- any inspector. diction authorized by the Secretary to Pasteurize means the subjecting of inspect eggs or egg products under the each particle of egg products to heat or authority of this part, under an agree- other treatments to destroy harmful ment entered into between the Sec- viable microorganisms by such proc- retary and the appropriate State or esses as may be prescribed by these other agency. regulations.

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Person means any individual, part- inspections as required in § 590.28 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. shall have the same meaning for pur- Sanitize means the application of a poses of this part as under the Federal bactericidal treatment which is ap- Food, Drug, and Cosmetic Act. proved as being effective in destroying Plant means any place of business microorganisms, including pathogens. where egg products are processed: Secretary means the Secretary of Ag- (a) Exempted plant means any plant riculture or his delegate. where the Administrator has deter- Service means the Agricultural Mar- mined the facilities and operating pro- keting Service (AMS) of the Depart- cedures meet such standards as may be ment. prescribed by this part, and where the Shell egg packer (grading station) eggs received or used in the manufac- means any person engaged in the sort- ture of egg products contain no more ing of eggs from sources other than or restricted eggs than are allowed by the in addition to his own production into official standards of U.S. Consumer their various qualities, either mechani- Grade B for shell eggs, and where an cally or by other means. exemption has been granted. Stabilization means the subjection of any egg product to a desugaring proc- (b) Official plant means any plant in ess. which the plant facilities, methods of State means any State of the United operation and sanitary procedures have States, the Commonwealth of Puerto been found suitable and adequate by Rico, the Virgin Islands of the United the Administrator for the continuous States, and the District of Columbia. inspection of egg products in accord- Ultimate consumer means any house- ance with this part and in which in- hold consumer, restaurant, institution, spection service is carried on. or any other party who has purchased Potable water means water that has or received shell eggs or egg products been approved by a State health au- for consumption. thority or other agency or laboratory United States means the States. acceptable to the Administrator as safe Washed ungraded eggs means eggs for drinking and suitable for food proc- which have been washed but not sized essing. or segregated for quality. Processing means manufacturing of White or albumen means, for the pur- egg products, including breaking eggs pose of this part, the product obtained or filtering, mixing, blending, pasteur- from the egg as broken from the shell izing, stabilizing, cooling, freezing or and separated from the yolk. drying, or packaging egg products at official plants. [36 FR 9814, May 28, 1971] Producer-packer means any producer EDITORIAL NOTE: For FEDERAL REGISTER ci- who sorts eggs only from his own pro- tations affecting § 590.5, see the List of CFR duction and packs them into their var- Sections Affected, which appears in the ious qualities. Finding Aids section of the printed volume and at www.fdsys.gov. Quality means the inherent properties of any product which determine ADMINISTRATION its relative degree of excellence. Regional Director means any employee § 590.10 Authority. of the Department in charge of inspec- The Administrator shall perform, for tion service in a designated geo- and under the supervision of the Sec- graphical region. retary, such duties as the Secretary Regulations means the provisions in may require in the enforcement or ad- this part. ministration of the provisions of the Regulatory inspector means any em- Act, and this part. The Administrator ployee of the U.S. Government, or may waive for a limited period any par- State or local jurisdiction, who is au- ticular provisions of the regulations to thorized by the Secretary to make such permit experimentation so that new

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procedures, equipment, and processing the Paperwork Reduction Act of 1980, techniques may be tested to facilitate Pub. L. 96–511. definite improvements and at the same (b) Display. time to maintain full compliance with 7 CFR section where identified and de- Current OMB the spirit and intent of the regulations. scribed control number The Agricultural Marketing Service and its officers and employees shall not § 590.10 ...... 0581–0113 § 590.13 ...... 0581–0113 be liable in damages through acts of § 590.22 ...... 0581–0113 commission or omission in the admin- § 590.28(a)(1) ...... 0581–0113 istration of this part. § 590.40 ...... 0581–0113 § 590.45(c)(1) ...... 0581–0113 [42 FR 2971, Jan. 14, 1977. Redesignated at 42 § 590.45(c)(3) ...... 0581–0113 FR 32514, June 27, 1977, and further redesig- § 590.45(d) ...... 0581–0113 nated at 46 FR 63203, Dec. 31, 1981] § 590.110(a) ...... 0581–0113 § 590.112 ...... 0581–0113 § 590.122 ...... 0581–0113 § 590.13 Federal and State coopera- § 590.124 ...... 0581–0113 tion. § 590.126 ...... 0581–0113 The Secretary shall, whenever he de- § 590.128(a) ...... 0581–0113 § 590.140 ...... 0581–0113 termines that it would effectuate the § 590.144 ...... 0581–0113 purposes of the Act, authorize the Ad- § 590.146(b) ...... 0581–0113 ministrator to cooperate with appro- § 590.146(d) ...... 0581–0113 § 590.155 ...... 0581–0113 priate State and other governmental § 590.160(c) ...... 0581–0113 agencies in carrying out any provisions § 590.160(d) ...... 0581–0113 of the Egg Products Inspection Act and § 590.160(f)(3) ...... 0581–0113 § 590.160(f)(4) ...... 0581–0113 these regulations. In carrying out the § 590.200(a) ...... 0581–0113 provisions of the Act and the regula- § 590.200(b) ...... 0581–0113 tions, the Secretary may conduct such § 590.220 ...... 0581–0113 examinations, investigations, and in- § 590.240 ...... 0581–0113 § 590.320 ...... 0581–0113 spections as he determines practicable § 590.402(a) ...... 0581–0113 through any officer or employee of any § 590.411(a) ...... 0581–0113 such agency commissioned by him for § 590.411(b) ...... 0581–0113 § 590.411(e) ...... 0581–0113 such purpose. The Secretary shall re- § 590.411(f) ...... 0581–0113 imburse the States and other agencies § 590.418(c) ...... 0581–0113 for the services rendered by them in § 590.430(b) ...... 0581–0113 § 590.435(b) ...... 0581–0113 such cooperative programs as agreed to § 590.435(c) ...... 0581–0113 in the cooperative agreements as § 590.440(c) ...... 0581–0113 signed by the Administrator and the § 590.500(h) ...... 0581–0113 duly authorized agent of the State or § 590.504(c) ...... 0581–0113 § 590.504(d) ...... 0581–0113 other agency. § 590.504(h) ...... 0581–0113 § 590.504(k) ...... 0581–0113 § 590.17 Nondiscrimination. § 590.504(o)(1) ...... 0581–0113 § 590.504(o)(2) ...... 0581–0113 The conduct of all services and the li- § 590.504(o)(3)(i) ...... 0581–0113 censing of graders and inspectors under § 590.504(o)(3)(iii) ...... 0581–0113 these regulations shall be accom- § 590.504(o)(3)(iv) ...... 0581–0113 § 590.504(o)(3)(v) ...... 0581–0113 plished without discrimination as to § 590.515(a)(8) ...... 0581–0113 race, color, religion, sex, national ori- § 590.520(h) ...... 0581–0113 gin, age, or disability. § 590.522(f) ...... 0581–0113 § 590.522(x) ...... 0581–0113 [40 FR 20057, May 8, 1975. Redesignated at 42 § 590.522(aa)(2) ...... 0581–0113 FR 32514, June 27, 1977. Further redesignated § 590.530(d) ...... 0581–0113 at 46 FR 63203, Dec. 31, 1981, and amended at § 590.534(a) ...... 0581–0113 § 590.544(b) ...... 0581–0113 60 FR 49169, Sept. 21, 1995] § 590.544(c) ...... 0581–0113 § 590.544(d) ...... 0581–0113 § 590.18 OMB control numbers as- § 590.552(a)(3) ...... 0581–0113 signed pursuant to the Paperwork § 590.552(b)(1)(i) ...... 0581–0113 Reduction Act. § 590.552(b)(2) ...... 0581–0113 § 590.570(c) ...... 0581–0113 (a) Purpose. This section collects and § 590.575(b)(3) ...... 0581–0113 displays the control numbers assigned § 590.575(d) ...... 0581–0113 to information collection requirements § 590.580(c) ...... 0581–0113 § 590.600 ...... 0581–0113 by the Office of Management and Budg- § 590.610(a) ...... 0581–0113 et contained in 7 CFR 590 pursuant to § 590.620 ...... 0581–0113

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7 CFR section where identified and de- Current OMB marked, and labeled as required by scribed control number these regulations. § 590.640(b)(1) ...... 0581–0113 § 590.680(a) ...... 0581–0113 § 590.28 Other inspections. § 590.800 ...... 0581–0113 (a) Periodic inspections shall be § 590.840 ...... 0581–0113 § 590.905(a) ...... 0581–0113 made of: § 590.915(a) ...... 0581–0113 (1) The records of all persons engaged § 590.915(b) ...... 0581–0113 in the business of transporting, ship- § 590.920 ...... 0581–0113 ping, or receiving any eggs or egg prod- § 590.930(f) ...... 0581–0113 § 590.950(a) ...... 0581–0113 ucts. § 590.960 ...... 0581–0113 (2) Exempted plants to determine § 590.965 ...... 0581–0113 that such plants are operating pursuant to these regulations. [48 FR 34238, July 28, 1983, as amended at 50 (b) Inspections shall be made of im- FR 23270, June 3, 1985; 54 FR 37290, Sept. 8, ported eggs and egg products as re- 1989] quired in this part.

SCOPE OF INSPECTION [36 FR 9814, May 28, 1971, as amended at 40 FR 20057, May 8, 1975. Redesignated at 42 FR § 590.20 Inspection in accordance with 32514, June 27, 1977, and further redesignated methods prescribed or approved. at 46 FR 63203, Dec. 31, 1981, as and amended at 60 FR 49169, Sept. 21, 1995; 63 FR 45675, Inspection of eggs and egg products Aug. 27, 1998; 63 FR 69971, Dec. 17, 1998] shall be rendered pursuant to these regulations and under such conditions RELATION TO OTHER AUTHORITIES and in accordance with such methods as may be prescribed or approved by § 590.30 At official plants. the Administrator. (a) Requirements within the scope of the Act with respect to premises, fa- § 590.22 Basis of service. cilities, and operations of any official These regulations provide for inspec- plant which are in addition to or dif- tion services pursuant to the Egg Prod- ferent than those made under this part ucts Inspection Act. Eggs and egg prod- may not be imposed by any State or ucts shall be inspected in accordance local jurisdiction except that any such with such standards, methods, and in- jurisdiction may impose recordkeeping structions as may be issued or ap- and other requirements within the proved by the Administrator. Inspec- scope of § 590.200, if consistent there- tion services shall be subject to super- with, with respect to any such plant. vision at all times by the applicable (b) Labeling, packaging, or ingre- Federal-State supervisor, egg products dient requirements in addition to or supervisor, Regional Director, and Na- different than those made under this tional Supervisor. part, the Federal Food, Drug, and Cos- metic Act and the Fair Packaging and § 590.24 Egg products plants requiring Labeling Act may not be imposed by continuous inspection. any State or local jurisdiction with re- No plant in which egg products proc- spect to egg products processed at any essing operations are conducted shall official plant in accordance with the process egg products without contin- requirements under this part and such uous inspection under these regula- Acts. tions, except as expressly exempted in § 590.100. § 590.35 Eggs and egg products outside official plants. § 590.26 Egg products entering or pre- Any State or local jurisdiction may pared in official plants. exercise jurisdiction with respect to Eggs and egg products processed in eggs and egg products for the purpose an official plant shall be inspected, of preventing the distribution for processed, marked, and labeled as re- human food purposes of any such arti- quired by these regulations. Egg prod- cles which are outside of the official ucts entering an official plant shall plant and are in violation of this part have been inspected, processed, or any of said Federal Acts or any

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State or local law consistent there- not denatured or decharacterized may with. be exported to foreign countries for industrial use or animal food under the [36 FR 9814, May 28, 1971. Redesignated at 42 FR 32514, June 27, 1977, and further redesig- following provisions: nated at 46 FR 63203, Dec. 31, 1981, as amend- (1) Authorized government official of ed at 63 FR 69971, Dec. 17, 1998] the foreign country shall approve the importation of such products into that EGGS AND EGG PRODUCTS NOT INTENDED country. FOR HUMAN FOOD (2) The egg products shall be shipped under U.S. Government seal and identi- § 590.40 Continuous inspection not fied as required in § 590.840. provided. (3) Provisions for the control of such Continuous inspection shall not be inedible product in the foreign country provided under this part at any plant to preclude its use as human food must for the processing of any egg products be established and approved by the Ad- which are not intended for use as ministrator. Such control may consist human food, but such articles prior to of, but not be limited to, receipt and their offer for sale or transportation in inspection by an appropriate U.S. Gov- commerce shall be denatured or ernment official, an official of an ap- decharacterized unless shipped under proved meat, poultry, or egg products seal as authorized in §§ 590.504(c), and inspection system of the foreign gov- identified as prescribed by the regula- ernment, or, when acceptable to the tions in this part to prevent their use Administrator, a foreign government for human food. Periodic inspections official including other foreign health shall be made of such operations and authorities. records to assure compliance with the (d) Foreign governments may peti- Act and the regulations in this part. tion the Administrator for approval to [37 FR 6657, Apr. 1, 1972. Redesignated at 42 import into this country egg products FR 32514, June 27, 1977, and further redesig- which are unwholesome, adulterated, nated at 46 FR 63203, Dec. 31, 1981, as amend- or otherwise unfit for human food pur- ed at 63 FR 69971, Dec. 17, 1998] poses that are not denatured or decharacterized for industrial use or § 590.45 Prohibition on eggs and egg animal food requirements. Such prod- products not intended for use as human food. ucts shall be subject to the provisions of this part and other applicable laws (a) No person shall buy, sell, or trans- and regulations for importation into port or offer to buy or sell, or offer or the United States. receive for transportation in commerce, any eggs or egg products which [48 FR 34238, July 28, 1983] are not intended for use as human food, unless they are denatured or REFRIGERATION OF SHELL EGGS decharacterized, unless shipped under seal as authorized in paragraphs (c) and § 590.50 Temperature and labeling requirements. (d) of this section or in §§ 590.504(c) and 590.720(a) and identified as required by (a) No shell egg handler shall possess the regulations in this part. any shell eggs that are packed into (b) No person shall import or export containers destined for the ultimate shell eggs classified as loss, inedible, or consumer unless they are stored and incubator rejects or any egg products transported under refrigeration at an which are unwholesome, adulterated, ambient temperature of no greater or are otherwise unfit for human food than 45°F (7.2°C). purposes, except as provided in para- (b) No shell egg handler shall possess graphs (c) and (d) of this section, unless any shell eggs that are packed into they are denatured or decharacterized containers destined for the ultimate and identified as required by the regu- consumer unless they are labeled to in- lations in this part. dicate that refrigeration is required. (c) Egg products which are unwhole- (c) Any producer-packer with an an- some, adulterated, or are otherwise nual egg production from a flock of unfit for human food purposes that are 3,000 or fewer hens is exempt from the

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temperature and labeling requirements § 590.105 Suspension or termination of of this section. exemptions. [63 FR 45675, Aug. 27, 1998] (a) The Administrator may immediately suspend or terminate any ex- EXEMPTIONS emption under § 590.100(b) at any time with respect to any person, if the con- § 590.100 Specific exemptions. ditions of exemption prescribed by this The following are exempt to the ex- section are not being met. The Admin- tent prescribed as to the provision for istrator may modify or revoke any reg- continuous inspection of processing op- ulation of this part, granting exemp- erations in section 5(a) of the Act: Pro- tions whenever he determines such ac- vided, That the conditions for exemption appropriate to effectuate the pur- tion and provisions of these regulations poses of the Act. are met: (b) Failure to comply with the condition of the exemptions contained in (a) [Reserved] § 590.100 shall subject such person to (b) Subject to the approval of the Ad- the penalties provided for in the Act ministrator as provided in §§ 590.600 and in this part. through 590.670, the processing of egg products without continuous inspec- [36 FR 9814, May 28, 1971, as amended at 40 tion at any plant where the facilities, FR 20057, May 8, 1975. Redesignated at 42 FR sanitation, and operating procedures 32514, June 27, 1977, and further redesignated at 46 FR 63203, Dec. 31, 1981] are the same as are required in this part for official plants and where the PERFORMANCE OF SERVICE eggs received or used in the manufacture of egg products contain no more § 590.110 Licensed inspectors. restricted eggs than are allowed by the (a) Any person who is a Federal or official standards for U.S. Consumer State employee, or the employee of a Grade B shell eggs, and the egg prod- local jurisdiction possessing proper ucts processed at such plant; qualifications as determined by an ex- (c)–(d) [Reserved] amination for competency and who is (e) The processing and sale of egg to perform services pursuant to this products by any poultry producer from part, may be licensed by the Secretary eggs of his own flock’s production when as an inspector. sold directly to a household consumer (b) Licenses issued by the Secretary exclusively for use by such consumer are to be countersigned by the Admin- and members of his household and his istrator or by any other designated of- nonpaying guests and employees; ficial of the Service. (f) [Reserved] (c) No person may be licensed to in- (g) The processing in nonofficial spect any product in which he is finan- plants, including but not limited to cially interested. bakeries, restaurants, and other food [36 FR 9814, May 28, 1971; 36 FR 10841, June 4, processors, without continuous inspec- 1971. Redesignated at 42 FR 32514, June 27, tion, of certain categories of food prod- 1977, and further redesignated at 46 FR 63203, ucts which contain eggs or egg prod- Dec. 31, 1981] ucts as an ingredient, and the sale and possession of such products: Provided, § 590.112 Suspension of license or au- That such products are manufactured thority; revocation. from inspected egg products processed Pending final action by the Sec- in accordance with this part or from retary, any person authorized to coun- eggs containing no more restricted tersign a license to perform inspection eggs than are allowed in the official services may, whenever he deems such standards for U.S. Consumer Grade B action necessary to assure that any in- shell eggs; spection service is properly performed, suspend any license to perform inspec- [36 FR 9814, May 28, 1971, as amended at 40 FR 20057, May 8, 1975. Redesignated at 42 FR tion services issued pursuant to this 32514, June 27, 1977, and further redesignated part by giving notice of such suspen- at 46 FR 63203, Dec. 31, 1981, as amended at 63 sion to the respective licensee, accom- FR 69971, Dec. 17, 1998] panied by a statement of the reasons

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therefor. Within 7 days after the re- leave of absence with or without pay. ceipt of the aforesaid notice and state- Willful violation of this section or ment of reasons by the licensee, he § 590.120 will constitute grounds for dis- may file an appeal in writing, with the missal in the case of appointees and Secretary, supported by any argument revocation of licenses in the case of li- or evidence that he may wish to offer censees. as to why his license should not be sus- [36 FR 9814, May 28, 1971, as amended at 42 pended or revoked. After the expiration FR 2971, Jan. 14, 1977. Redesignated at 42 FR of the aforesaid 7-day period and con- 32514, June 27, 1977, and further redesignated sideration of such argument and evi- at 46 FR 63203, Dec. 31, 1981] dence, the Secretary will take such action as he deems appropriate with re- § 590.120 Financial interest of inspec- spect to such suspension or revocation. tors. When no appeal is filed within the pre- No inspector shall inspect any prod- scribed 7 days, the license is revoked or uct in which he is financially inter- suspended. ested.

§ 590.114 Surrender of license. § 590.122 Time of inspection. Upon termination of his services as The inspector who is to perform the an inspector or whenever his license inspection in an official plant shall be has been suspended or revoked, the li- given reasonable advance notice by censee shall surrender his license and plant management of the hours when other items of identification furnished such inspection will be required. by the Department immediately to the inspection service. [60 FR 49169, Sept. 21, 1995]

§ 590.116 Activities of inspectors. § 590.124 Schedule of operation of official plants. Inspectors at official plants shall confine their activities to those duties Operating schedules for an official necessary in the rendering of inspec- plant shall be subject to approval of tion service and such closely related the Administrator. The normal oper- activities as may be approved by the ating schedule shall consist of a con- Administrator. tinuous 8-hour period per day and shall include the time for FSIS inspection § 590.118 Identification. program personnel to put on required Inspectors shall have in their posses- gear and to walk to a work station, and sion at all times while on duty, and the time for FSIS inspection program present upon request, the means of personnel to return from a work sta- identification furnished by the Depart- tion and remove required gear (exclud- ment to such persons. ing not to exceed 1 hour for lunch), 5 consecutive days per week, within the [36 FR 9814, May 28, 1971; 36 FR 10841, June 4, administrative workweek, Sunday 1971. Redesignated at 42 FR 32514, June 27, through Saturday, for each full shift 1977, and further redesignated at 46 FR 63203, Dec. 31, 1981] required. Clock hours of daily operations need not be specified in a sched- § 590.119 Political activity. ule, although as a condition of continu- Inspectors are forbidden during the ance of approval of a schedule, the period of their respective appoint- hours of operation must be reasonably ments, or licenses, to take an active uniform from day to day. part in political management or in po- [48 FR 20683, May 9, 1983, as amended at 76 litical campaigns. Political activity in FR 33980, June 10, 2011] city, county, State, or national elec- tions, whether primary or regular, or § 590.126 Overtime inspection service. in behalf of any party or candidate, ex- When operations in an official plant cept as authorized by law or regulation require the services of inspection per- of the Department, is prohibited. This sonnel beyond their regularly assigned applies to all appointees, including but tour of duty on any day or on a day not being limited to temporary and co- outside the established schedule, such operative employees and employees on services are considered as overtime

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work. The official plant must give rea- mulas set forth in § 592.510(b), and the sonable advance notice to the inspector cost of living increases and percentage of any overtime service necessary and of inflation factors set forth in must pay for such overtime. For each § 592.510(c) of this chapter. calendar year, FSIS will calculate the (b) The term ‘‘holiday’’ shall mean overtime rate for inspection service, the legal public holidays specified by per hour per program employee, using the Congress in paragraph (a) of sec- the following formula: The quotient of tion 6103, title 5 of the United States dividing the Office of Field Operations Code. Information on legal holidays plus Office of International Affairs in- may be obtained from the supervisor. spection program personnel’s previous fiscal year’s regular direct pay by the [37 FR 6657, Apr. 1, 1972. Redesignated at 42 FR 32514, June 27, 1977, as amended at 46 FR previous fiscal year’s regular hours, 9, Jan. 2, 1981. Redesignated at 46 FR 63203, plus the quotient multiplied by the cal- Dec. 31, 1981, as amended at 47 FR 46071, Oct. endar year’s percentage of cost of liv- 15, 1982; 59 FR 52637, Oct. 18, 1994; 65 FR 60095, ing increase, multiplied by 1.5, plus the Oct. 10, 2000; 67 FR 3430, Jan. 24, 2002; 68 FR benefits rate, plus the travel and oper- 37957, June 26, 2003; 71 FR 2143, Jan. 13, 2006; ating rate, plus the overhead rate, plus 76 FR 20228, Apr. 12, 2011] the allowance for bad debt rate. FSIS calculates the benefits rate, the travel § 590.130 Basis of billing plants. and operating rate, the overhead rate, Overtime and/or holiday services and the allowance for bad debt rate shall be billed to the official plant on using the formulas set forth in the basis of each 15 minutes of over- § 592.510(b) and the cost of living in- time and/or holiday service performed creases and percentage of inflation fac- by each inspector providing such serv- tors set forth in § 592.510(c) of this chap- ice to the plant, except that when an ter. official plant requires the services of [71 FR 2143, Jan. 13, 2006, as amended at 76 an inspector after he has completed his FR 20228, Apr. 12, 2011] day’s assignment and left the plant or when he is called back to duty on a day § 590.128 Holiday inspection service. outside the established normal oper- (a) When an official plant requires in- ating schedule or on a holiday, the offi- spection service on a holiday or a day cial plant shall pay for a minimum of 2 designated in lieu of a holiday, such hours service at the applicable estab- service is considered holiday work. The lished rate. Extra travel expense in- official plant must, in advance of such curred while rendering overtime or hol- holiday work, request the inspector in iday service shall be billed to the offi- charge to furnish inspection service cial plant. Bills are payable upon re- during such period and must pay the ceipt and become delinquent 30 days Agency for such holiday work at the from date of billing. Overtime or holi- hourly rate. For each calendar year, day inspection service will not be per- FSIS calculates the holiday rate for informed at any plant that is delinquent, spection service, per hour per program and processing operations shall be con- employee, using the following formula: fined to the regular operating schedule The quotient of dividing the Office of of the plant. In addition, fees will be Field Operations plus Office of Inter- charged and collected for certifications national Affairs inspection program requested by and provided for the offi- personnel’s previous fiscal year’s reg- cial plant that are not within the scope ular direct pay by the previous fiscal of these regulations. year’s regular hours, plus the quotient [36 FR 9814, May 28, 1971. Redesignated at 42 multiplied by the calendar year’s per- FR 32514, June 27, 1977, and further redesig- centage of cost of living increase, mul- nated at 46 FR 63203, Dec. 31, 1981, as amend- tiplied by 2, plus the benefits rate, plus ed at 60 FR 49169, Sept. 21, 1995; 65 FR 44950, the travel and operating rate, plus the July 20, 2000] overhead rate, plus the allowance for bad debt rate. FSIS will calculate the § 590.132 Access to plants. benefits rate, the travel and operating Access shall not be refused to any rate, the overhead rate, and the allow- representative of the Secretary to any ance for bad debt rate using the for- plant, place of business, or transport

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vehicle subject to inspection under the APPLICATION FOR SERVICE provisions of this part upon presentation of proper credentials. § 590.140 How application shall be made. [63 FR 45675, Aug. 27, 1998] The proprietor or operator of each § 590.134 Accessibility of product and plant processing egg products, unless cooler rooms. exempted by § 590.100, shall make application to the Administrator for inspec- (a) Each product for which inspection tion service. The application shall be service is required shall be so placed as made in writing on forms furnished by to disclose fully its class, quality, the inspection service. In cases of quantity, and condition as the cir- change of name or ownership or change cumstances may warrant. of location, a new application shall be (b) The perimeter of each cooler made. room used to store shell eggs packed in containers destined for the ultimate § 590.142 Filing of application. consumer shall be made accessible in An application for inspection service order for the Secretary’s representa- shall be regarded as filed only when it tives to determine the ambient tem- has been filled in completely and perature under which shell eggs are signed by the applicant and has been stored. received in the office of the Chief of the [36 FR 9814, May 28, 1971. Redesignated at 42 Grading Branch. FR 32514, June 27, 1977, and further redesig- [36 FR 9814, May 28, 1971. Redesignated at 42 nated at 46 FR 63203, Dec. 31, 1981, as amend- FR 32514, June 27, 1977, as amended at 43 FR ed at 63 FR 45675, Aug. 27, 1998] 60138, Dec. 26, 1978. Redesignated at 46 FR 63203, Dec. 31, 1981] § 590.136 Facilities and equipment to be furnished by official plants for § 590.144 Authority of applicant. use of inspectors in performing service. Proof of authority of any person applying for inspection service may be re- (a) Such facilities and equipment quired at the discretion of the Admin- shall include but not be limited to a istrator. room or area suitable for sampling product, and acceptable candling light, § 590.146 Application for continuous flashlight, heavy duty, high speed drill inspection in official plants; ap- with an eleven sixteenths-inch or larg- proval. er bit of sufficient length to reach the Any person desiring to process egg bottom of containers used for frozen products under continuous inspection eggs, metal stem thermometer(s), test service must receive approval of such thermometer(s), stop watch, test plant and facilities as an official plant weighing scale(s) and test weight(s), prior to the installation of such serv- test kit for determining the bacteri- ice. An application for continuous in- cidal strength of sanitizing solutions, spection service to be installed in an and stationary or adequately secured official plant shall be approved accord- storage box or cage (capable of being ing to the following procedure: locked only by the inspector) for hold- (a) Initial survey: When an applica- ing official samples. tion for continuous inspection in a (b) Furnished office space and equip- plant has been filed, a supervisory egg ment, including but not being limited products inspector will make a survey to a desk (equipped with a satisfactory and inspection of the premises and locking device), lockers or cabinets plant to determine if the facilities and suitable for the protection and storage methods of operation therein are suit- of supplies, and facilities suitable for able and adequate for service in accord- inspectors to change clothing. ance with: [36 FR 9814, May 28, 1971. Redesignated at 42 (1) These regulations, and FR 32514, June 27, 1977, and further redesig- (2) Such other administrative in- nated at 46 FR 63203, Dec. 31, 1981, as amend- structions as may be issued from time ed at 60 FR 49169, Sept. 21, 1995] to time by the Service and which are in

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effect at the time of the aforesaid sur- ucts storage rooms (including coolers, vey and inspection. freezers, hot rooms), drying rooms, toi- (b) Drawings and specifications to be let and dressing rooms, storerooms for furnished: supplies, and all other rooms, compart- (1) Applicants may obtain informa- ments, or passageways where products tion or assistance as to the require- or any ingredients to be used in the ments before submitting prints of preparation of products under this drawings, specifications, and supple- service will be handled or kept and mental information from the inspec- may include other rooms located in the tion service. building comprising the official plant. (2) Three copies of each print drawing Except in public warehouses, all rooms, as specified in this section of the com- compartments, etc., of the building not plete floor plan, plot plan, supple- to be considered as part of the official mental information, and specifications plant shall not have direct access into shall be submitted. Sheet size of the any part of the official plant. print shall not exceed 34 by 44 inches, (7) Supplemental information may be the wording shall be legible, all lines shown as notations on the drawings or sharp and clear, and properly drawn to on supplemental sheets. Supplemental scale. Each print shall show the scale information shall include clarifying in- used, north point of the compass, and formation such as sequence of proc- the firm name, street, city, state, and essing edible products, handling of in- zip code or an accurate description of edible product, shell disposal, handling the location. of packaging material, liquid pumping (3) Plot plan of entire premises shall systems, cleaned-in-place systems, de- include location of all buildings, rail- scription of pasteurizer, description of roads, roadways, alleys, wells, res- drier, type and efficiency of air filtra- ervoirs, drains, catch basins, nearby tion, hot water facilities, sewage dis- buildings adjoining property, drainage posal, and such other notations as may and slope of terrain, character and sur- be required. facing of roadways, driveways, and ve- (8) Specification sheets shall include hicular loading areas. The plot plan height of ceilings and type construc- may be drawn to a scale of one-thirty- tion, type of floors, and wall construc- second inch per foot. tion, wall and partition material, and (4) Floor plan prints shall include all number of employees who will use each space on each floor of the official toilet room and facilities. plant, accurately illustrating and de- (c) Upon approval of the prints of scribing the facilities. Detailed draw- drawing, supplemental information, ings of processing area shall be drawn and specifications, the application for to a scale of one-fourth inch per foot. service may be approved. Prints showing only nonprocessing (d) Changes and revisions of official areas may be drawn to a scale of one- plant: When changes are planned in of- eighth inch per foot. ficial plant construction, facilities, and (5) Floor plans shall show the loca- equipment covered by previously ap- tion of such features as walls, parti- proved prints, revised prints shall be tions, posts, doorways, windows, floor submitted for review and approval drains and channel drains, air systems, prior to making the changes by: A ventilation fans, principal pieces of completely revised sheet(s) showing equipment, storage tanks, hose connec- proposed alterations and additions or tions for cleaning purposes, hand-wash- an overlay print drawn to same scale ing facilities, lockers, and toilets. The as print to be modified or revised. A prints shall show slope of floors to final survey of the completed alter- drains. ations and additions shall be made by (6) The official plant shall include all the supervisory egg products inspector processing rooms and other rooms used to determine if the changes are in ac- in the official plant, including but not cordance with approved drawings and being limited to the breaking room, the regulations. equipment washing and sanitizing (e) Final survey and plant approval: rooms, shell egg washing rooms, pack- Prior to the inauguration of contin- aging rooms, shell egg and egg prod- uous inspection service, a final survey

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of the plant and premises shall be made ice, that such applicant or recipient is by the supervisory egg products inspec- unfit to engage in any business requir- tor to determine if the plant is con- ing inspection under the Act or this structed and facilities are installed in part, because the applicant or recipient accordance with the approved drawings or anyone responsibly connected with and these regulations. The plant may such person has been convicted in any be approved only when these require- Federal or State court, within the pre- ments have been met. vious 10 years, of (1) any felony or more than one misdemeanor under any law [36 FR 9814, May 28, 1971; 36 FR 10841, June 4, 1971. Redesignated at 42 FR 32514, June 27, based upon the acquiring, handling, or 1977, and further redesignated at 46 FR 63203, distributing of adulterated, mislabeled, Dec. 31, 1981] or deceptively packaged food or fraud in connection with transactions in food § 590.148 Order of service. or (2) any felony, involving, fraud, brib- Inspection service shall be per- ery, extortion, or any other act or cir- formed, insofar as practicable, in the cumstances indicating a lack of the in- order in which applications therefor tegrity needed for the conduct of oper- are made. ations affecting the public health. (b) For the purpose of this section, a [36 FR 9814, May 28, 1971, as amended at 42 person shall be deemed to be respon- FR 2971, Jan. 14, 1977. Redesignated at 42 FR 32514, June 27, 1977, and further redesignated sibly connected with the business if he at 46 FR 63203, Dec. 31, 1981] is a partner, officer, director, holder, or owner of 10 percentum or more of its INAUGURATION OF SERVICE voting stock, or employee in a managerial or executive capacity. § 590.150 Official plant numbers. (c) The determination and order of An official plant number shall be as- the Administrator with respect thereto signed to each plant granted inspection under this section shall be final and service. Such plant number shall be conclusive unless the affected appli- used to identify all containers of in- cant for, or recipient of, inspection spected products prepared in the plant service files application for judicial re- which are capable of use as human view within 30 days after the effective food. A plant shall not have more than date of such order in the U.S. Court of one plant number. Appeals for the circuit in which such applicant or recipient has its principal § 590.155 Inauguration of service. place of business or in the U.S. Court of Prior to the inauguration of service, Appeals for the District of Columbia the proprietor or operator of the plant Circuit. Judicial review of any such shall be knowledgeable of the require- order shall be upon the record upon ments of these regulations. which the determination and order are based. The provisions of section 204 of [36 FR 9814, May 28, 1971. Redesignated at 42 the Packers and Stockyards Act, 1921, FR 32514, June 27, 1977, and further redesignated at 46 FR 63203, Dec. 31, 1981, as amend- as amended (7 U.S.C. 194) shall be applied at 60 FR 49169, Sept. 21, 1995] cable to appeals taken under this section. This section shall not affect in DENIAL OF SERVICE any way other provisions of the Act or these regulations for refusal of inspec- § 590.160 Refusal, suspension, or with- tion services. drawal of service. (d) Any applicant for inspection at a (a) The Administrator (for such pe- plant where the operations thereof may riod, or indefinitely, as he deems nec- result in any discharge into the navi- essary to effectuate the purposes of the gable waters in the United States is re- Act) may refuse to provide or may quired by subsection 401(a)(1) (33 U.S.C. withdraw inspection service under this 1341) of the Clean Water Act as amend- part with respect to any plant if he de- ed (86 Stat. 816, 91 Stat. 1566; 33 U.S.C. termines after opportunity for a hear- 1251 et seq.), to provide the Adminis- ing (following the procedures of 7 CFR, trator with a certification, as pre- part 1, subpart H) is accorded to the ap- scribed in said subsection, that any plicant for, or recipient of, such serv- such discharge will comply with the

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applicable provisions of sections 301, processing egg products shall also be- 302, 303, 306, and 307 of the Act (33 come terminated. U.S.C. 1311, 1312, 1313, 1316, and 1317). No (3) The operator shall be notified of grant of inspection can be issued unless the withdrawal action and the reasons such certification has been obtained, or therefor and afforded an opportunity to is waived, because of failure or refusal present his views informally prior to of the State, interstate agency, or the the effective date of such withdrawal, Administrator of the Environmental and upon written request, he shall be Protection Agency to act on a request afforded an opportunity for a hearing for certification within a reasonable in accordance with the applicable rules period (which shall not exceed 1 year of practice (7 CFR, part 1, subpart H), after receipt of such request). Further, with respect to the merits or validity upon receipt of an application for in- of the withdrawal, but such a suspen- spection and a certification as required sion or other withdrawal shall continue by subsection 401(a)(1) of the Clean in effect pending the outcome of any Water Act, the Administrator (as de- such hearing unless otherwise ordered fined in § 590.5) is required by subpara- by the Administrator. graph (2) of said subsection to notify the Administrator of the Environ- (4) In any case where inspection serv- mental Protection Agency for pro- ice is suspended under this paragraph ceedings in accordance with that sub- (f) of this section, such service, after section. No grant of inspection can be appropriate corrective action is taken, made until the requirements of 401(a) will be restored immediately, or as (1) and (2) have been met. soon thereafter as an inspector can be (e) Inspection may be suspended or made available. In any case where in- revoked and plant approval terminated spection service is withdrawn for a as provided in subsection 401(a) (4) and specified period under this paragraph (5) of the Clean Water Act, as amended (f) of this section, the person concerned (33 U.S.C. 1341(a) (4) and (5)). may, after said specified period has ex- (f) Suspension of plant approval and pired, apply for inspection service as withdrawal of service: provided in §§ 590.140 through 590.146. (1) Any plant approval given pursu- [36 FR 9814, May 28, 1971, as amended at 37 ant to these regulations may be sus- FR 6657, Apr. 1, 1972. Redesignated at 42 FR pended by the Administrator for (i) 32514, June 27, 1977, as amended at 43 FR failure to maintain premises, facilities, 60138, Dec. 26, 1978; 45 FR 23640, Apr. 8, 1980. and equipment in a satisfactory state Redesignated at 46 FR 63203, Dec. 31, 1981] of repair; (ii) the use of operating procedures or practices which are not in § 590.161 Termination of plant ap- accordance with the regulations; (iii) proval. the alterations of buildings, facilities, When inspection service is not per- or equipment which have not been ap- formed at any plant for a period of at proved in accordance with the regula- least 90 days, plant approval shall ter- tions; or (iv) assaulting, intimidating, minate upon notice by the Adminis- impeding, obstructing, or interfering trator without further proceedings; with any person engaged in or on ac- provided, however, that this section count of the performance of his official shall not apply to any plant where the duties. Administrator determines that such a (2) During such period of suspension, plant operates on a seasonal basis and no processing of egg products for com- the inspection service has not been merce shall be carried on in the official used as a result of such seasonal oper- plant. If the plant facilities or methods ation, or where operations have ceased of operation are not brought into com- due to extraordinary circumstances de- pliance within a reasonable period of termined by the Administrator as not time, to be specified by the Adminis- warranting termination of plant ap- trator, inspection service shall be with- proval. drawn from the official plant. Upon withdrawal of inspection service in an [45 FR 23641, Apr. 8, 1980. Redesignated at 46 official plant, the plant approval for FR 63203, Dec. 31, 1981]

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RECORDS AND RELATED REQUIREMENTS retary upon any premises, and there is FOR EGGS AND EGG PRODUCTS HAN- reason to believe that they are or have DLERS AND RELATED INDUSTRIES been processed, bought, sold, possessed, used, transported, or offered or re- § 590.200 Records and related require- ceived for sale or transportation in vio- ments. lation of the Act or the regulations in (a) Persons engaged in the business of this part, or that they are in any other transporting, shipping, or receiving way in violation of the Act, such arti- any eggs or egg products in commerce, cles may be detained by such rep- or holding such articles so received, resentative for a period not to exceed and all egg handlers, including hatch- 20 days, as more fully provided in sec- eries, shall maintain records showing, tion 19 of the Act. A detention tag or for a period of 2 years, to the extent other similar device shall be used to that they are concerned therewith, the identify detained product, and the cus- receipt, delivery, sale, movement, and todian or owner shall be given a writ- disposition of all eggs and egg products ten notice of such detention. Only au- handled by them, and shall, upon the thorized representatives of the Sec- request of an authorized representative retary shall affix or remove detention of the Secretary, permit him, at rea- identification. The provisions of this sonable times, to have access to and to section shall in no way derogate from copy all such records. authority for condemnation or seizure (b) Production records by categories conferred by other provisions of the of eggs such as graded eggs, nest-run Act, the regulations in this part, or eggs, dirties, checks, leakers, loss, in- other laws. edible, etc., bills of sale, inventories, receipts, shipments, shippers, receiv- [37 FR 6658, Apr. 1, 1972. Redesignated at 42 ers, dates of shipment and receipt, car- FR 32514, June 27, 1977, and further redesig- rier names, etc., as determined by the nated at 46 FR 63203, Dec. 31, 1981, as amended at 63 FR 69972, Dec. 17, 1998] Administrator, shall be maintained by all egg processing operations, except APPEAL OF AN INSPECTION OR DECISION that, official egg products plants which use all shell eggs received and do not § 590.300 Who may request an appeal reship any shell eggs need only to inspection or review of an inspec- maintain records indicating the tor’s decision. amount of eggs received, date received, Any appeal inspection may be re- and the name and address of the ship- quested by any interested party who is per. dissatisfied with the determination by [37 FR 6657, Apr. 1, 1972. Redesignated at 42 an inspector of the class, quantity, or FR 32514, June 27, 1977, and further redesig- condition of any product, and a review nated at 46 FR 63203, Dec. 31, 1981, as amend- may be requested by the operator of an ed at 47 FR 745, Jan. 7, 1982; 63 FR 69971, Dec. official plant with respect to an inspec- 17, 1998] tor’s decision or on any other matter § 590.220 Information and assistance related to inspection in the official to be furnished to inspectors. plant. When inspection service is performed [36 FR 9814, May 28, 1971. Redesignated at 42 at any plant, the plant operator shall FR 32514, June 27, 1977, and further redesig- furnish the inspector such information nated at 46 FR 63203, Dec. 31, 1981, as amend- and assistance as may be required for ed at 60 FR 49169, Sept. 21, 1995] the performance of inspection func- § 590.310 Where to file an appeal. tions, preparing certificates, reports, and for other official duties. (a) Appeal of resident inspector’s inspection or decision in an official plant. ADMINISTRATIVE DETENTION Any interested party who is not satisfied with the determination of the § 590.240 Detaining product. class, quantity, or condition of product Whenever any eggs or egg products which was inspected by an inspector in subject to the Act are found by any au- an official plant and has not left such thorized representative of the Sec- plant, and the operator of any official

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plant who is not satisfied with a deci- shall be promptly notified of the rea- sion by an inspector on any other mat- son(s) for such refusal. ter relating to inspection in such plant [60 FR 49169, Sept. 21, 1995, as amended at 63 may request an appeal inspection or re- FR 69972, Dec. 17, 1998] view of the decision by the inspector by filing such request with the inspector’s § 590.340 Who shall perform the ap- immediate supervisor. peal. (b) All other appeal requests. Any in- (a) An appeal inspection or review of terested party who is not satisfied with a decision requested under § 590.310(a) the determination of the class, quan- shall be made by the inspector’s imme- tity, or condition of product which has diate supervisor or by a licensed in- left the official plant where it was inspector assigned by the immediate suspected may request an appeal inspec- pervisor other than the inspector whose inspection or decision is being tion by filing such request with the Re- appealed. gional Director in the region where the (b) The assignment of the inspec- product is located or with the Chief of tor(s) who will make the appeal inspec- the Grading Branch. tion under § 590.310(b) shall be made by [36 FR 9814, May 28, 1971. Redesignated at 42 the Regional Director or the Chief of FR 32514, June 27, 1977, as amended at 43 FR the Grading Branch, Poultry Division, 60138, Dec. 26, 1978. Redesignated at 46 FR Agricultural Marketing Service. 63203, Dec. 31, 1981, as amended at 60 FR 49169, Sept. 21, 1995; 63 FR 69972, Dec. 17, 1998] § 590.350 Procedures for selecting appeal samples. § 590.320 How to file an appeal. (a) Prohibition on movement of product. The request for an appeal inspection Products shall not have been moved or review of an inspector’s decision from the place where the inspection may be made orally or in writing. If being appealed was performed and must have been maintained under adequate made orally, written confirmation may refrigeration when applicable. be required. The applicant shall clearly (b) Laboratory analyses. The appeal state the identity of the product, the sample shall consist of product taken decision which is questioned, and the from the original sample containers reason(s) for requesting the appeal plus an equal number of containers se- service. If such appeal request is based lected at random. When the original on the results stated on an official cer- sample containers cannot be located, tificate, the original and all copies of the appeal sample shall consist of prod- the certificate available at the appeal uct taken at random from double the inspection site shall be provided to the number of original sample containers. inspector assigned to make the appeal (c) Condition inspection. The appeal inspection. sample shall consist of product taken from the original sample containers [60 FR 49169, Sept. 21, 1995] plus an equal number of containers se- § 590.330 When an application for an lected at random. A condition appeal appeal inspection may be refused. cannot be made unless all originally sampled containers are available. When it appears to the official with whom an appeal request is filed that [36 FR 9814, May 28, 1971. Redesignated at 42 FR 32514, June 27, 1977, and further redesig- the reasons given in the request are nated at 46 FR 63203, Dec. 31, 1981, as amend- frivolous or not substantial, or that ed at 60 FR 49169, Sept. 21, 1995] the condition of the product has undergone a material change since the origi- § 590.360 Appeal inspection certifi- nal inspection, or that the original lot cates. has changed in some manner, or the Immediately after an appeal inspec- Act or the regulations in this part have tion is completed, an appeal certificate not been complied with, the applicant’s shall be issued to show that the origi- request for the appeal inspection may nal inspection was sustained or was not be refused. In such case, the applicant sustained. Such certificate shall super- sede any previously issued certificate

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for the product involved and shall an inspection certificate covering prod- clearly identify the number and date of uct inspected in whole or in part by an- the superseded certificate. The other inspector when the inspector has issuance of the appeal certificate may knowledge that the product is eligible be withheld until any previously issued for certification based on personal ex- certificate and all copies have been re- amination of the product or official in- turned when such action is deemed nec- spection records. essary to protect the interest of the (b) Each egg products inspection cer- Government. When the appeal inspec- tificate shall show the name and ad- tor assigns a different class to the lot dress of the processor, the class and or determines that a net weight short- quantity of the egg products covered age exists, the lot shall be retained by such certificate, such shipping pending correction of the labeling or marks as are necessary to identify such approval of the product disposition by products, all pertinent information the National Supervisor. concerning the wholesomeness thereof, [36 FR 9814, May 28, 1971. Redesignated at 42 and such other information as the Ad- FR 32514, June 27, 1977, and further redesig- ministrator may prescribe or approve. nated at 46 FR 63203, Dec. 31, 1981, as amended at 60 FR 49169, Sept. 21, 1995] § 590.404 Erasures or alterations made on official certificates. § 590.370 Cost of appeals. Erasures or alterations shall be ini- (a) There shall be no cost to the ap- tialed by the issuing inspector on the pellant when the appeal inspection dis- original certificate and any copy there- closes a material error was made in the of. All certificates made useless original determination. through clerical error or otherwise and (b) The costs of an appeal shall be all certificates canceled for whatever borne by the appellant at an hourly cause shall be voided and initialed and rate of $27.36, including travel time and the original and all other copies shall expenses if the appeal was frivolous, in- be forwarded as prescribed by the Ad- cluding but not being limited to the ministrator. following: The appeal inspection discloses that no material error was made § 590.406 Disposition of official certifi- in the original inspection, the condi- cates. tion of the product has undergone a The original and up to two copies of material change since the original in- each official certificate shall be issued spection, the original lot has changed to the applicant or person designated in some manner, or the Act or these by him. Other copies shall be filed and regulations have not been complied retained in accordance with the dis- with. position schedule for inspection program records. [36 FR 9814, May 28, 1971. Redesignated at 42 FR 32514, June 27, 1977, as amended at 46 FR IDENTIFYING AND MARKING PRODUCT 49571, Oct. 7, 1981. Redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 58 FR 57539, Oct. 26, 1993; 59 FR 52636, Oct. 18, 1994] § 590.410 Shell eggs and egg products required to be labeled. CERTIFICATES (a) All shell eggs packed into containers destined for the ultimate con- § 590.400 Form of certificates. sumer shall be labeled to indicate that All certificates shall be issued on refrigeration is required, e.g., ‘‘Keep forms approved by the Administrator. Refrigerated,’’ or words of similar meaning. § 590.402 Egg products inspection cer- (b) Containers and portable tanks of tificates. edible egg products, prior to leaving (a) Upon request of the applicant or the official plant, shall be labeled in the Service, any inspector is author- accordance with §§ 590.411 through ized to issue an egg products inspection 590.415 and shall bear the official iden- certificate with respect to any lot of tification shown in Figure 2 of § 590.412 egg products inspected by him. In addi- or Figure 3 or 4 of § 590.415. Bulk trans- tion, an inspector is authorized to issue port shipments of liquid pasteurized

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egg products to nonofficial outlets need clude the percentage of ingredients in not be sealed. Bulk shipments of liquid both liquid and dried form. egg products transported from one offi- (2) When required, scientific data cial plant to another shall be sealed demonstrating that the substance or and accompanied by an official certifi- mixture is safe and effective for its in- cate. tended use and does not promote decep- [40 FR 20058, May 8, 1975. Redesignated at 42 tion or cause the product to be other- FR 32514, June 27, 1977, and further redesig- wise adulterated or misbranded. nated at 46 FR 63203, Dec. 31, 1981, as amend- (c) Containers of product bearing of- ed at 63 FR 45675, Aug. 27, 1998] ficial identification shall display the following information: § 590.411 Requirement of formulas and approval of labels for use in official (1) The common or usual name, if egg products plants. any, and if the product is comprised of (a) No label, container, or packaging two or more ingredients, such ingredi- material which bears official identi- ents shall be listed in the order of de- fication may bear any statement that scending proportions by weight in the is false or misleading. Any label, conform in which the product is to be mar- tainer, or packaging material which keted (sold), except that ingredients in bears any official identification shall dried products (other than dry blended) be used only in such manner as the Ad- may be listed in either liquid or dried ministrator may prescribe. No label, form. When water (excluding that used container, or packaging material bear- to reconstitute dehydrated ingredients ing official identification may be used back to their normal composition) is unless it is approved by the Adminis- added to a liquid or frozen egg product trator in accordance with paragraph (b) or to an ingredient of such products (in of this section. The use of finished la- excess of the normal water content of bels must be approved as prescribed by that ingredient), the total amount of the Administrator. If the label is print- water added, including the water con- ed on or otherwise applied directly to tent of any cellulose or vegetable gums the container or packaging material, used, shall be expressed as a percentage the principal display panel thereof of the total product weight in the in- shall be considered as the label. gredient statement on the label. (b) No label, container, or packaging (2) The name, address, and ZIP code material bearing official identification of the packer or distributor. When the may be printed or prepared for use distributor is shown, it shall be quali- until the printers’ or other final proof fied by such terms as ‘‘packed for,’’ has been approved by the Adminis- ‘‘distributed by,’’ or ‘‘distributors’’; trator in accordance with the regula- (3) The lot number or approved alter- tions in this part, the Egg Products In- native code number indicating date of spection Act, the Federal Food, Drug, production; and Cosmetic Act, the Fair Packaging (4) The net contents; and Labeling Act, and the regulations (5) Official identification and plant promulgated under these acts. Copies of each label submitted for approval number; shall be accompanied by: (6) Egg products which are produced (1) A statement showing by their in an official plant from edible shell common or usual names the kinds and eggs of other than current production percentages of the ingredients com- or from other egg products produced prising the egg product. A range may from shell eggs of other than current be given in cases where the percentages production, shall be clearly and dis- may vary from time to time. Formulas tinctly labeled in close proximity to are to be expressed in terms of a liquid the common or usual name of the prod- product except for products which are uct, e.g., ‘‘Manufactured from eggs of dry blended. Also, for products to be other than current production’’; dried, the label may show the ingredi- (7) Egg products produced from edible ents in the order of descending propor- shell eggs or the egg product produced tions by weight in the dried form. How- from such shell eggs of the turkey, ever, the formula submitted must in- duck, goose, or guinea shall be clearly

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and distinctly labeled as to the com- with nutrition labeling, if the nutri- mon or usual name of the product indi- ent(s) is otherwise not referred to in la- cating the type of eggs or egg products beling or in advertising. All labels used in the product, e.g., ‘‘Frozen showing nutrition information or whole turkey eggs,’’ ‘‘Frozen whole claims are subject to review by the chicken and turkey eggs.’’ Egg prod- Food and Drug Administration prior to ucts labeled without qualifying words approval by the Department. as to the type of shell egg used in the (f) If the Administrator has reason to product shall be produced only from believe that the statement on formula- the edible shell egg of the domesticated tion shows the product to be adulter- chicken or the egg product produced ated or misbranded or that any label- from such shell eggs. ing, or the size or form of any con- (d) Liquid or frozen egg products tainer in use or proposed for use in re- identified as whole eggs and prepared spect to egg products at any official other than in natural proportions, as plant is false or misleading in any way, broken from the shell, shall have a he may direct that such use be with- total egg solids content of 24.20 percent held unless the labeling or container is or greater. modified in such a manner as he may (e) Nutrition information may be in- prescribe so that it will not be false or cluded on labels used to identify egg misleading, and/or the formulation of products, providing such labeling com- the product is altered in such a manner plies with the provisions of 21 CFR part that he may prescribe so that it is not 101, promulgated under the Federal adulterated, or would not cause mis- Food, Drug, and Cosmetic Act and the branding. Any person so denied the ap- Fair Packaging and Labeling Act. proval of any label shall be notified Since these regulations have different promptly of the reasons for the denial requirements for consumer packaged on a form approved by the Adminis- products than for bulk packaged egg trator. If the person using or proposing products not for sale or distribution to to use the label does not accept the de- household consumers, label submission termination of the Administrator, he shall be accompanied with information may request a hearing by filing with indicating whether the label covers the Administrator within 10 days after consumer packaged or bulk packaged receiving the notice of denial, a writ- product. Nutrition labeling is required ten application for a hearing setting when nutrients, such as proteins, vita- forth specifically, the errors alleged to mins, and minerals are added to the have been made by the Administrator product, or when a nutritional claim or in denying approval of the label. The information is presented on the label- use of the label shall be withheld pending, except for the following which are ing hearing and final determination by exempt from nutrition labeling re- the Administrator if the Administrator quirements: so directs. Hearings held pursuant to (1) Egg products shipped in bulk form this subsection shall be presided at by for use solely in the manufacture of the Administrator. The applicant shall other food and not for distribution to be given the opportunity to present household consumers in such bulk form evidence both oral and written in sup- or containers. port of his allegation that the Adminis- (2) Products containing an added vi- trator erred in denying approval of the tamin, mineral, or protein, or for label. The notice of denial together which a nutritional claim is made on with all other available data and infor- the label, or in advertising, which is mation used as a basis for such denial supplied for institutional food use only: shall be considered part of the record. Provided, That the manufacturer or dis- The Administrator may take official tributor provides the required nutri- notice of such matters as are judicially tion information directly to those in- noticed by the Courts of the United stitutions. States and of any other matter of tech- (3) Any nutrient(s) included in prod- nical, scientific, or commercial fact of uct solely for technological purpose established character. The Adminis- may be declared solely in the ingredi- trator shall make his final determina- ents statement, without complying tion with respect to the matter upon

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the basis of evidence before him. Such determination shall be conclusive unless, within 30 days after the receipt of notice of such final determination, the person adversely affected thereby appeals to the U.S. Court of Appeals for the circuit in which he has his principal place of business, or to the U.S. Court of Appeals for the District of Co- lumbia Circuit. The provisions of section 204 of the Packers and Stockyards Act of 1921, as amended, shall be applicable to appeals taken under this section. [37 FR 6658, Apr. 1, 1972, as amended at 40 FR 20058, May 8, 1975. Redesignated at 42 FR 32514, June 27, 1977, as amended at 45 FR 23641, Apr. 8, 1980. Redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 53 FR 23751, June 24, 1988; 60 FR 49169, Sept. 21, 1995]

§ 590.412 Form of official identification symbol and inspection mark. (a) The shield set forth in Figure 1 containing the letters ‘‘USDA’’ shall be the official identification symbol for purposes of this part and, when used, imitated, or simulated in any manner in connection with a product, shall be deemed to constitute a representation that the product has been officially inspected. (b) The inspection mark which is to be used on containers of edible egg products shall be contained within the outline of a shield and with the wording and design set forth in Figure 2 of [36 FR 9814, May 28, 1971, as amended at 40 this section, except the plant number FR 20058, May 8, 1975. Redesignated at 42 FR may be preceded by the letter ‘‘P’’ in 32514, June 27, 1977, and further redesignated lieu of the word ‘‘plant’’. Alternatively, at 46 FR 63203, Dec. 31, 1981, as amended at 60 it may be omitted from the official FR 49170, Sept. 21, 1995] shield if applied on the container’s § 590.414 Products bearing the official principal display panel or other promi- inspection mark. nent location and preceded by the letter ‘‘P’’ or the word ‘‘Plant’’. Egg products which are permitted to bear the inspection mark shall be processed in an official plant from edible shell eggs or other edible egg products and may contain other edible ingredients. The official mark shall be printed or lithographed and applied as a part of the principal display panel of the container but shall not be applied to a detachable cover.

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§ 590.415 Use of other official identification. Other official identification as shown in this section shall be printed or lithographed and applied as a part of the principal display panel, but shall not be applied to a detachable cover. The plant number may be omitted from the identification if applied elsewhere on the container’s principal display panel or other prominent location and preceded by the letter ‘‘P’’ or the word [36 FR 9814, May 28, 1971; 36 FR 10841, June 4, ‘‘plant’’. Such products shall meet all 1971. Redesignated at 42 FR 32514, June 27, requirements for egg products which 1977, and further redesignated at 46 FR 63203, are permitted to bear the official in- Dec. 31, 1981, as amended at 60 FR 49170, Sept. spection mark shown in § 590.412, except 21, 1995] for pasteurization, heat treatment, or § 590.417 Unauthorized use or disposi- other such methods of treatment ap- tion of approved labels. proved by the Administrator. Such products shall not be released into con- (a) Containers or labels which bear suming channels until they have been official identification approved for use pursuant to § 590.411 shall be used only subjected to pasteurization, heat treat- for the purpose for which approved. ment, or other approved methods of Any unauthorized use or disposition of treatment. approved containers or labels which (a) All nonpasteurized egg products, bear any official identification may re- except as provided in paragraph (b) of sult in cancellation of the approval and this section, shipped from an official denial of the use of containers or labels plant in packaged form shall be bearing official identification and may marked with the identification set subject such violator to the penalties forth in Figure 3 of this section. After and denial of the benefits of the Act; pasteurization or treatment, the prod- (b) The use of simulations or imita- uct may bear the official inspection tions of any official identification by mark as shown in § 590.412. any person is prohibited; (c) Upon termination of inspection service in an official plant pursuant to these regulations, all labels or packaging materials indicating product packed by the plant which bear official identification shall either be destroyed under the supervision of the Service or, if used in another location, modified in a manner acceptable to the Service before use. [36 FR 9814, May 28, 1971, as amended at 40 (b) All nonpasteurized egg products, FR 20059, May 8, 1975; 42 FR 2971, Jan. 14, containing 10 percent or more added 1977. Redesignated at 42 FR 32514, June 27, salt, shipped from an official plant in 1977, and further redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 60 FR 49170, Sept. packaged form to an acidic dressing 21, 1995] manufacturer shall be marked with the identification set forth in Figure 4 of § 590.418 Supervision of marking and this section. packaging. (a) Evidence of label approval. No inspector shall authorize the use of official identification on any inspected product unless he has on file evidence that such official identification or

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packaging material bearing such offi- some egg product under this part, shall cial identification has been approved in be made pursuant to the voluntary egg accordance with the provisions of products inspection service (part 55 of § 590.411. this chapter). (b) Affixing of official identification. No (b) Any food manufacturing estab- official identification shall be, or lishment or institution which uses any caused to be affixed to or placed on any eggs that do not meet the requirements product or container except by an in- of § 590.100(a) in the preparation of any spector or under the supervision of an articles for human food shall be inspector or other person authorized by deemed to be a plant processing egg the Administrator. All such products products requiring continuous inspec- shall have been inspected in accord- tion under this part. ance with these regulations. The in- (c) Any product which is prepared spector shall have supervision over the under inspection in an official plant use and handling of all material bear- shall be inspected in such plant as ing any official identification. often as the inspector deems necessary (c) Labels for products sold under Gov- in order to ascertain if the product is ernment contract. The inspector in the unadulterated, wholesome, properly la- official plant may approve use of labels beled, and fit for human food at the for containers of product sold under a time it leaves the plant. Upon any such contract specification to governmental inspection, if any product or portion agencies when such product is not of- thereof is found to be adulterated, un- fered for resale to the general public: wholesome, or otherwise unfit for Provided, That the contract specifica- human food, such product or portion tions have been approved by the Ad- thereof shall be condemned and shall ministrator and include complete spe- receive such treatment as provided in cific requirements with respect to la- § 590.422. beling and are made available to the inspector. § 590.422 Condemnation. Eggs and egg products found to be § 590.419 Reuse of containers bearing adulterated at official plants shall be official identification prohibited. condemned and, if no appeal be taken The reuse, by any person, of con- from such determination of condemna- tainers bearing official identification is tion, such articles shall be destroyed prohibited unless such identification is for human food purposes under the su- applicable in all respects to product pervision of an inspector: Provided, being packed therein. In such in- That articles which may by reprocess- stances, the container and label may be ing be made not adulterated need not used provided the packaging is accom- be condemned and destroyed if so re- plished under the supervision of an in- processed under the supervision of an spector and the container is in compli- inspector and thereafter found to be ance with § 590.504(k). not adulterated. If an appeal is requested, the eggs or egg products shall INSPECTION, REINSPECTION, be appropriately marked and seg- CONDEMNATION, AND RETENTION regated pending completion of an appeal inspection. The appeal shall be at § 590.420 Inspection. the cost of the appellant if the Admin- (a) Continuous inspection shall be istrator determines that the appeal is made, pursuant to these regulations, of frivolous, as defined in § 590.370. the processing of egg products in each official plant processing egg products § 590.424 Reinspection. for commerce unless exempted under (a) No egg product may be brought § 590.100. Inspections, certifications, or into an official plant except as pro- specification-type gradings, and other vided in § 590.430(b) unless it has been inspections which may be requested by prepared and handled in accordance the official plant and are in addition to with these regulations, and the con- the normal inspection requirements tainer of such product is marked so as and functions for the processing, pro- to identify the article as so inspected duction, or certification of a whole- in accordance with this part.

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(b) All egg products shall be rein- when no edible product is being proc- spected by an inspector at the time essed. All equipment and processing they are brought into the official areas must be thoroughly cleaned and plant. Upon reinspection, if any such sanitized prior to processing any edible product or portion thereof is found to product. be unsound, unwholesome, adulterated, [36 FR 9814, May 28, 1971, as amended at 40 or otherwise unfit for human food, such FR 20059, May 8, 1975. Redesignated at 42 FR product or portion thereof, shall be 32514, June 27, 1977, and further redesignated condemned and shall receive such at 46 FR 63203, Dec. 31, 1981] treatment as provided in § 590.422, and shall, in the case of other products be § 590.435 Wholesomeness and approval disposed of according to applicable law. of materials. (a) Substances and ingredients used § 590.426 Retention. in the manufacture or preparation of Retention tags or other devices and any egg product capable of use as methods as may be approved by the Ad- human food shall be clean, wholesome, ministrator shall be used for the iden- and unadulterated. tification and control of products (b) The use of chemical additives in which are not in compliance with the egg products shall be permitted only regulations or are held for further ex- when they are approved by the Admin- amination, and any equipment, uten- istrator. The Administrator may re- sils, rooms or compartments which are quire, in addition to listing the ingredi- found to be unclean or otherwise in ents, a declaration of the additive, and violation of the regulations. No prod- the purpose of its use. uct, equipment, utensil, room, or com- (c) Chemical additives to be used in partment shall be released for use until the preparation of egg products will be it has been made acceptable. Such approved only if they comply with the identification shall not be removed by following criteria: anyone other than an inspector. (1) The additive shall be safe under the conditions of its intended use. ENTRY OF MATERIAL INTO OFFICIAL EGG (2) The additive shall not promote de- PRODUCTS PLANTS ception or cause the product to be otherwise adulterated or unwholesome. § 590.430 Limitation on entry of mate- Scientific data acceptable to the Ad- rial. ministrator showing that the additive (a) The Administrator shall limit the meets the criteria specified in this entry of eggs and egg products and paragraph (c) shall be submitted by the other materials into official plants person interested in having the addi- under such conditions as he may pre- tive approved. scribe to assure that allowing the (d) Containers and packing or pack- entry of such articles will be consistent aging materials in which shell eggs are with the purposes of the Act and these received into the official plant shall be regulations. free from odors and materials which (b) Inedible egg products may be could contaminate or adulterate the brought into an official plant for stor- eggs or egg products. age and reshipment: Provided, they are handled in such a manner that ade- § 590.440 Processing ova. quate segregation and inventory con- (a) Ova from slaughtered poultry trols are maintained at all times. Ined- may be brought into the official plant ible egg products may be processed in for processing: Provided, That the ova official plants: Provided, That prior ap- is from wholesome poultry inspected in proval is obtained from the Adminis- a plant operating under the Poultry trator and under such conditions and Products Inspection Act (21 U.S.C. 451 time limitations as the Administrator et seq.) and such product is harvested in may specify. The processing of inedible a sanitary manner, properly handled, egg products shall be done under condi- cooled, packaged and labeled: And pro- tions which will not affect the proc- vided further, That such product is essing of edible products, such as proc- wholesome and the containers of such essing in separate areas, or at times product bear official identification

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which assures the provisions of this drains shall be equipped with traps, paragraph have been met. and constructed so as to minimize clog- (b) The ova and products containing ging. In new or remodeled construction ova shall be processed, cooled, and pas- the drainage systems from toilets and teurized in the official plant in the laboratories shall not be connected same manner as liquid, frozen, or dried with other drainage systems within the yolk products. plant. (c) The labeling for all products con- (h) The water supply (both hot and taining ova shall be approved by the cold) shall be ample, clean, and pota- Administrator prior to use. ble, with adequate pressure and facilities for its distribution throughout the SANITARY, PROCESSING, AND FACILITY plant or portion thereof utilized for egg REQUIREMENTS processing and handling operations and § 590.500 Plant requirements. protected against contamination and pollution. A water report, issued under (a) The plant shall be free from objec- the authority of a State or municipal tionable odors, dust, and smokeladen health agency, certifying to the pota- air. bility of the water supply shall be ob- (b) The premises shall be free from tained by the applicant and furnished refuse, rubbish, waste, and other mate- to the Administrator whenever such re- rials and conditions which constitute a port is required by the Administrator. source of odors or a harbor for insects, (i) The floors, walls, ceiling, parti- rodents, and other vermin. tions, posts, doors, and other parts of (c) The buildings shall be of sound all structures shall be of such mate- construction and kept in good repair to rials, construction, and finish to per- prevent the entrance or harboring of mit their ready and thorough cleaning. vermin. The floors and curbing shall be water- (d) Rooms shall be kept free from tight. refuse, rubbish, waste materials, odors, insects, rodents, and from any condi- (j) Each room and each compartment tions which may constitute a source of in which any shell eggs or egg products odors or engender insects and rodents. are handled or processed shall be so de- Materials and equipment not currently signed, constructed, and maintained to needed shall be handled or stored in a insure processing and operating condi- manner so as not to constitute a sani- tions of a clean and orderly character, tary hazard. free from objectionable odors and va- (e) Doors and windows that open to pors, and maintained in a clean and the outside shall be protected against sanitary condition. the entrance of flies and other insects. (k) Every precaution shall be taken Doors and windows serving rooms to exclude dogs, cats, and vermin (in- where edible product is exposed shall cluding, but not being limited to, ro- be so designed and installed to prevent dents and insects) from the plant, or the entrance of dust and dirt. Doors portion thereof utilized in which shell leading into rooms where edible prod- eggs or egg products are handled or uct is processed shall be of solid con- stored. struction and such doors, other than (l)(1) There shall be a sufficient num- freezer and cooler doors, shall be fitted ber of adequately lighted dressing with self-closing devices. rooms and toilet rooms, ample in size, (f) Doors and other openings which conveniently located and separated are accessible to rodents shall be of ro- from the rooms and compartments in dent-proof construction. which shell eggs or egg products are (g) There shall be an efficient drain- handled, processed, or stored. The age and plumbing system for the plant dressing rooms and toilet rooms shall and premises. Drains and gutters shall be separately ventilated, and shall be properly installed with approved meet all requirements as to sanitary traps and vents. The sewage system construction and equipment. shall have adequate slope and capacity (2) The following formula shall serve to readily remove waste from the var- as a basis for determining the toilet fa- ious processing operations. Floor cilities required:

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Toilet an efficient, clean, and satisfactory Persons of same sex bowls re- manner; quired (2) Permit easy access to all parts to 1 to 15, inclusive ...... 1 insure thorough cleaning and sani- 16 to 35, inclusive ...... 2 tizing. So far as is practicable, all such 1 36 to 55, inclusive ...... 3 equipment shall be made of metal or 56 to 80, inclusive ...... 1 4 For each additional 30 persons in excess of 80 ... 1 1 other impervious material which will not affect the product by chemical ac- 1 Urinals may be substituted for toilet bowls but only to the extent of one-third of the total number of bowls stated. tion or physical contact. (b) Except as authorized by the Ad- (m) Lavatory accommodations (in- ministrator, in new or remodeled cluding, but not being limited to, hot equipment and equipment installa- and cold running water, single service tions, the equipment and installation towels, and soap which does not impart shall comply with the applicable 3–A or an odor which interferes with accurate E–3–A Sanitary Standards and accepted evaluation of the product) shall be practices currently in effect for such placed at such locations in the plant to equipment. assure cleanliness of each person han- (c) New or replacement equipment or dling any shell eggs or egg products. machinery (including any replacement The hand washing facilities in the parts) brought onto the premises of processing areas shall be operated by any official plant shall not contain liq- other than hand operated controls and uid polychlorinated biphenyls (PCBs) the drains shall be trapped and con- in concentrations above 50 parts per nected to the plumbing system. million by weight of the liquid me- (n) Suitable facilities for cleaning dium. This provision applies to both and sanitizing utensils and equipment food processing and nonfood processing shall be provided at convenient loca- equipment and machinery, and any re- tions throughout the plant. placement parts for such equipment (o) Refuse rooms shall be provided for and machinery. Totally enclosed ca- the accumulation and storage of shells, pacitors containing less than 3 pounds trash, and other refuse. They shall be of PCBs are exempted from this prohi- separate rooms completely enclosed bition. without doorways opening into breaking rooms or rooms where egg products [36 FR 9814, May 28, 1971. Redesignated at 42 or packaging materials are handled or FR 32514, June 27, 1977, as amended at 45 FR 68919, Oct. 17, 1980. Redesignated at 46 FR stored and have concrete floors with 63203, Dec. 31, 1981, as amended at 60 FR approved drains, facilities for cleaning, 49170, Sept. 21, 1995] and an approved exhaust system vented to the outside. Alternative systems of § 590.504 General operating proce- handling shells, trash, and other refuse dures. may be approved by the Administrator (a) Operations involving processing, when such systems adequately contain storing, and handling of shell eggs, in- all refuse and provide equivalent sani- gredients, and egg products shall be tary methods for the handling and re- strictly in accord with clean and sani- moval of refuse. tary methods and shall be conducted as [36 FR 9814, May 28, 1971; 36 FR 10841, June 4, rapidly as practicable. Pasteurization, 1971, as amended at 40 FR 20059, May 8, 1975. heat treatment, stabilization, and Redesignated at 42 FR 32514, June 27, 1977, as other processes shall be in accord with amended at 45 FR 23641, Apr. 8, 1980. Redesig- this part and as approved by the Ad- nated at 46 FR 63203, Dec. 31, 1981] ministrator. Processing methods and temperatures in all operations shall be § 590.502 Equipment and utensils; such as will prevent a deterioration of PCB-containing equipment. the egg products. (a) Equipment and utensils used in (b) Shell eggs and egg products proc- processing shell eggs and egg products essed in official plants shall be sub- shall be of such design, material, and jected to constant and continuous in- construction as will: spection throughout each and every (1) Enable the examination, segrega- processing operation. Any shell egg or tion, and processing of such products in egg product which was not processed in

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accordance with these regulations or is within 72 hours from time of breaking not fit for human food shall be removed for egg products other than whites and segregated. which are to be desugared. (c) All loss and inedible eggs or egg (f) Each person who is to handle any products shall be placed in a container exposed or unpacked egg products or clearly labeled ‘‘inedible’’ and con- any utensils or container which may taining a sufficient amount of approved come into contact with egg product, denaturant or decharacterant, such as shall wash his hands and maintain FD&C brown, blue, black, or green col- them in a clean condition. ors, meat and fish by-products, grain (g) No product or material which cre- and milling by-products, or any other ates an objectionable condition shall substance, as approved by the Adminis- be processed, stored, or handled in any trator, that will accomplish the pur- room, compartment, or place where poses of this section. Shell eggs shall any shell eggs or egg products are proc- be crushed and the substance shall be essed, stored or handled. dispersed through the product in (h) Only germicides, insecticides, amounts sufficient to give the product rodenticides, detergents, or wetting a distinctive appearance or odor. Not- agents or other similar compounds withstanding the foregoing, and upon which will not deleteriously affect the permission of the Inspector, the appli- eggs or egg products when used in an cant may hold inedible product in con- approved manner and which have been tainers clearly labeled inedible which approved by the Administrator, may be do not contain a denaturant if such in- used in an official plant. The identi- edible product is denatured or fication, storage, and use of such com- decharacterized prior to shipment from pounds shall be in a manner approved the official plant: Provided, That such by the Administrator. product is properly packaged, labeled, segregated, and inventory controls are (i) Utensils and equipment which are maintained. In addition, product contaminated during the course of shipped from the official plant for in- processing any shell eggs or egg prod- dustrial use or animal food need not be ucts shall be removed from use imme- denatured or decharacterized, provided, diately and shall not be used again that such product is properly pack- until cleaned and sanitized. aged, labeled, segregated, and inven- (j) Any substance or ingredient added tory controls are maintained, and that in the processing of any egg products such product is shipped under Govern- shall be clean and fit for human food. ment seal and certificate and received (k) Packages or containers for egg at the destination location by an in- products shall be of sanitary design spector or grader as defined in this and clean when being filled with any part. egg products; and all reasonable pre- (d) The inspector may, prior to re- cautions shall be taken to avoid soiling ceipt of laboratory results for sal- or contaminating the surface of any monella, or for other reasons such as package or container liner which is, or labeling as to solids content, permit will be, in direct contact with such egg egg products to be shipped from the of- products. Only new containers or used ficial plant when he has no reason to containers that are clean, in sound suspect noncompliance with any of the condition and lined with suitable inner provisions of this part. However, such liners shall be used for packaging edi- shipments shall be made under cir- ble egg products. Fiber containers used cumstances which will assure the re- without liners require the approval of turn of the product to the plant for re- the Administrator. processing, relabeling, or under such (l) Egg products shall be inspected to other conditions as the Administrator determine the wholesomeness of the may determine to assure compliance finished product. with this part. (m) Egg products shall be processed (e) Pasteurizing, stabilizing, or dry- in such a manner as to insure the im- ing operations shall start as soon as mediate removal of blood and meat practicable after breaking to prevent spots, shell particles, and foreign mate- deterioration of product, preferably rials.

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(n) Utensils and equipment, except mission from the Administrator to re- drying units, powder conveyors, sifters, ceive and use unpasteurized egg prod- blenders, and mechanical powder cool- ucts. The applicant shall sign a written ers shall be clean and sanitized at the statement containing the specification start of processing operations. Equip- for the treatment of the nonpasteur- ment and utensils shall be kept clean ized egg product in a manner that will and sanitary during all processing op- insure that viable salmonella micro- erations. organisms are destroyed, and such (o) Egg products prior to being reprocessing treatment shall be approved leased into consuming channels shall by the Administrator prior to use. be pasteurized in accordance with (ii) Product shall be shipped under § 590.570 except that dried whites pre- seal from the official plant, accom- pared from nonpasteurized liquid shall panied by an official USDA certificate be heat treated in accordance with stating that the product is nonpasteur- § 590.575. ized and for use in acidic dressings (1) To assure adequate pasteuriza- only. tion, egg products shall be sampled and (iii) The applicant shall acknowledge tested for the presence of salmonella. receipt of each shipment by indicating Sampling for the presence of sal- on the reverse side of the USDA certifi- monella shall be in accordance with cate. ‘‘The quantity of nonpasteurized § 590.580 and product found to be sal- egg product stated on this certificate monella positive shall be reprocessed, was received at lllll,’’ the blank pasteurized, and analyzed for the pres- being filled in with the name and ad- ence of salmonella, or denatured. dress of the receiving company and the (2) Nonpasteurized or salmonella date and signature of the person com- positive egg product may be shipped pleting the form. The certificate shall from an official plant only when it is to be returned to the USDA inspector at be pasteurized, repasteurized, or heat the origin plant. treated in another official plant. Ship- (iv) The acidic dressing manufacturer ments of products from one official plant to another for pasteurization, re- shall maintain processing records indi- pasteurization, or heat treatment shall cating the use of each shipment of be in sealed cars or trucks with an ac- unpasteurized salted product and the companying certificate stating that code lots of acidic dressing into which the product is not pasteurized or is sal- it was processed. Records of the pH and monella positive. If nonpasteurized or the acidity expressed as percent acetic salmonella positive products are to be acid of each code lot shall be main- stored in other than the official plant tained. The records shall also dem- facilities, the inspector at the con- onstrate that the acidic dressing was signee’s and consignor’s plants shall be held 72 hours prior to shipment. These given full knowledge of the disposition records shall be maintained for 2 years of the product, including warehouse in- and shall be available for inspection by ventory receipts, until such time as a representative of the Department. product is pasteurized, repasteurized, (v) Each container of salted egg prod- or heat treated. The containers of such uct shipped from the official plant nonpasteurized or salmonella positive shall be labeled as required in § 590.411, product shall be marked with the iden- and shall bear the words ‘‘Caution— tification mark shown in Figure 3 of this egg product has not been pasteur- § 590.415. ized or otherwise treated to destroy (3) Notwithstanding the provision of viable salmonella microorganisms,’’ paragraph (o)(2) of this section, nonpas- and shall bear the official identifica- teurized salted egg products containing tion shown in figure 4 of § 590.415. 10 percent or more salt added may be (p) Air which is to come in contact shipped from an official plant directly with product or with product contact to a manufacturer of acidic dressings surfaces shall come from approved fil- only under the following provisions: tered outside air sources. (i) Before such shipment is made, the (q) All liquid and solid waste mate- manufacturer of the acidic dressing rial in the official plant shall be dis- shall apply in writing and receive per- posed of in a manner approved by the

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Administrator to prevent product con- § 590.508 Candling and transfer-room tamination and in accordance with ac- operations. ceptable environmental protection (a) Candling and transfer rooms and practices. equipment shall be kept clean, free [36 FR 9814, May 28, 1971, as amended at 37 from cobwebs, dust, objectionable FR 6658, Apr. 1, 1972; 40 FR 20059, May 8, 1975. odors, and excess packing materials. Redesignated at 42 FR 32514, June 27, 1977, (b) Containers for trash and inedible and further redesignated at 46 FR 63203, Dec. eggs shall be removed from the can- 31, 1981, as amended at 47 FR 745, Jan. 7, 1982; dling rooms as often as necessary but 60 FR 49170, Sept. 21, 1995] at least once daily; and shall be cleaned and treated in such a manner § 590.506 Candling and transfer-room as will prevent off odors or objection- facilities and equipment. able conditions in the plant. (a) The room shall be so constructed (c) Shell eggs shall be handled in a that it can be adequately darkened to manner to minimize sweating prior to assure accuracy in removal of inedible breaking. or loss eggs by candling. Equipment (d) Shell eggs with extensively damaged shells, unless prohibited under shall be arranged so as to facilitate § 590.510(d), shall be placed into leaker cleaning and the removal of refuse and trays and shall be broken promptly. excess packing material. (b) The construction of the floor shall § 590.510 Classifications of shell eggs allow thorough cleaning. The floors used in the processing of egg prod- shall be of water-resistant composition ucts. and provided with proper drainage. (a) The shell eggs shall be sorted and (c) An approved exhaust system shall classified into the following categories be provided for the continuous removal in a manner approved by the National directly to the outside of any steam, Supervisor: vapors, odors, or dust in the room. The (1) Eggs listed in paragraph (d) of this room shall be maintained at reasonable section. working temperatures during oper- (2) Dirty. ations. (3) Leakers as described in paragraph (d) Candling devices of an approved (c)(2) of this section. (4) Eggs from other than chicken; type shall be provided to enable can- duck, turkey, guinea, and goose eggs. dlers to detect loss, inedible, dirty (5) Other eggs—satisfactory for use as eggs, and eggs other than chicken eggs. breaking stock. (e) Leaker trays shall be made of a (b) Shell eggs having strong odors or material and of such design that is con- eggs received in cases having strong ducive to easy cleaning and sanitizing. odors shall be candled and broken sepa- (f) Containers made of a material and rately to determine their accept- of such design that are conducive to ability. easy cleaning shall be provided for in- (c) Shell eggs, when presented for edible eggs. All such containers shall breaking, shall be of edible interior be conspicuously marked. quality and the shell shall be sound (g) Containers made of a material and free of adhering dirt and foreign and of such design that are conducive material, except that: to easy cleaning shall be provided for (1) Checks and eggs with a portion of trash unless clean, disposable con- the shell missing may be used when the tainers are furnished daily. shell is free of adhering dirt and for- (h) Shell egg conveyors shall be con- eign material and the shell membranes are not ruptured. structed so that they can be thor- (2) Eggs with clean shells which are oughly cleaned. damaged in candling and/or transfer [36 FR 9814, May 28, 1971, as amended at 37 and have a portion of the shell and FR 6659, Apr. 1, 1972. Redesignated at 42 FR shell membranes missing may be used 32514, June 27, 1977, and further redesignated only when the yolk is unbroken and at 46 FR 63203, Dec. 31, 1981, as amended at 60 the contents of the egg are not exuding FR 49170, Sept. 21, 1995] over the outside shell. Such eggs shall

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be placed in leaker trays and be broken shall be maintained throughout the promptly. cleaning cycle. (3) Eggs with meat or blood spots (3) An approved cleaning compound may be used if the spots are removed in shall be used in the wash water. (The an acceptable manner. use of metered equipment for dis- (d) All loss or inedible eggs shall be pensing the compound into solution is placed in a designated container and be recommended.) handled as required in § 590.504(c). Ined- (4) Wash water shall be changed ap- ible and loss eggs for the purpose of proximately every 4 hours or more this section and § 590.522 are defined to often if needed to maintain sanitary include black rots, white rots, mixed conditions and at the end of each shift. rots, green whites, eggs with diffused Remedial measures shall be taken to blood in the albumen or on the yolk, prevent excess foaming during the egg crusted yolks, stuck yolks, developed washing operation. embryos at or beyond the blood ring (5) Replacement water shall be added state, moldy eggs, sour eggs, any eggs continuously to the wash water of that are adulterated as such term is de- washers to maintain a continuous over- fined pursuant to this part, and any flow. Rinse water and chlorine sani- other filthy and decomposed eggs in- tizing rinse may be used as part of the cluding the following: replacement water. Iodine sanitizing (1) Any egg with visible foreign mat- rinse may not be used as part of the re- ter other than removable blood and placement water. meat spots in the egg meat. (6) Waste water from the egg washing (2) Any egg with a portion of the operation shall be piped directly to shell and shell membranes missing and drains. with egg meat adhering to or in con- (7) The washing operation shall be tact with the outside of the shell. continuous and shall be completed as (3) Any egg with dirt or foreign mate- rapidly as possible. Eggs shall not be rial adhering to the shell and with allowed to stand or soak in water. Im- cracks in the shell and shell mem- mersion-type washers shall not be branes. used. (4) Liquid egg recovered from shell (8) Prewetting shell eggs prior to egg containers and leaker trays. washing may be accomplished by (5) Open leakers made in the washing spraying a continuous flow of water operation. over the eggs in a manner which per- (6) Any egg which shows evidence mits the water to drain away, or by that the contents are or have been ex- other methods which may be approved uding prior to transfer from the case. by the Administrator. (e) Incubator reject eggs shall not be (b) Shell eggs shall not be washed in brought into the official plant. the breaking room or any room where [36 FR 9814, May 28, 1971, as amended at 40 edible products are processed. FR 20059, May 8, 1975. Redesignated at 42 FR [36 FR 9814, May 28, 1971, as amended at 40 32514, June 27, 1977, and further redesignated FR 20059, May 8, 1975. Redesignated at 42 FR at 46 FR 63203, Dec. 31, 1981] 32514, June 27, 1977, and further redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 60 § 590.515 Egg cleaning operations. FR 49170, Sept. 21, 1995] (a) The following requirements shall be met when washing shell eggs to be § 590.516 Sanitizing and drying of shell presented for breaking: eggs prior to breaking. (1) Shell egg cleaning equipment (a) Immediately prior to breaking, shall be kept in good repair and shall all shell eggs shall be spray rinsed with be cleaned after each day’s use or more potable water containing an approved frequently if necessary. sanitizer of not less than 100 ppm nor (2) The temperature of the wash more than 200 ppm of available chlo- water shall be maintained at 90 °F or rine or its equivalent. Alternative pro- higher, and shall be at least 20 °F cedures may be approved by the Ad- warmer than the temperature of the ministrator in lieu of sanitizing shell eggs to be washed. These temperatures eggs washed in the plant.

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(b) Shell eggs shall be sufficiently by automatic, closed packaging sys- dry at time of breaking to prevent con- tems. tamination or adulteration of the liq- [36 FR 9814, May 28, 1971, as amended at 37 uid egg product from free moisture on FR 6659, Apr. 1, 1972. Redesignated at 42 FR the shell. 32514, June 27, 1977, and further redesignated at 46 FR 63203, Dec. 31, 1981] [60 FR 49170, Sept. 21, 1995] § 590.522 Breaking room operations. § 590.520 Breaking room facilities. (a) The breaking room shall be kept (a) The breaking room shall have at in a dust-free clean condition and free least 30 foot-candles of light on all from flies, insects, and rodents. The working surfaces except that light in- floor shall be kept clean and reason- tensity shall be at least 50 foot-candles ably dry during breaking operations at breaking and inspection stations. and free of egg meat and shells. Lights shall be protected with ade- (b) All breaking room personnel shall quate safety devices. wash their hands thoroughly with odor- (b) The surface of the ceiling and less soap and water each time they walls shall be smooth and made of a enter the breaking room and prior to water-resistant material. receiving clean equipment after break- (c) The floor shall be of water-proof ing an inedible egg. (c) Paper towels or tissues shall be composition, reasonably free from used at breaking tables, and shall not cracks or rough surfaces, sloped for be reused. Cloth towels are not per- adequate drainage, and the intersec- mitted. tions with walls and curbing shall be (d) Breakers shall use a complete set impervious to water. of clean equipment when starting work (d) Ventilation shall provide for: and after lunch periods. All table (1) A positive flow of outside filtered equipment shall be rotated with clean air through the room; equipment every 21⁄2 hours. (2) Air of suitable working tempera- (e) Cups shall not be filled to over- ture during operations. flowing. (e) There shall be provided adequate (f) Each shell egg shall be broken in hand washing facilities which are eas- a satisfactory and sanitary manner and ily accessible to all breaking per- inspected for wholesomeness by smell- sonnel, an adequate supply of warm ing the shell or the egg meat and by water, clean towels or other facilities visual examination at the time of for drying hands, odorless soap, and breaking. All egg meat shall be reex- containers for used towels. Hand wash- amined by a person qualified to perform such functions before being ing facilities shall be operated by other emptied into the tank or churn, except than hand operated controls. as otherwise approved by the National (f) Containers for packaging egg Supervisor. products are not acceptable as liquid (g) Shell particles, meat and blood egg buckets. spots, and other foreign material acci- (g) A suitable container conspicu- dentally falling into the cups or trays ously identified shall be provided for shall be removed with a spoon or other the disposal of rejected liquid. approved instrument. (h) Strainers, filters, or centrifugal (h) Whenever an inedible egg is bro- clarifiers of approved construction ken, the affected breaking equipment shall be provided for the effective re- shall be cleaned and sanitized. moval of shell particles and foreign (i) Inedible and loss eggs as defined in material, unless specific approval is ob- § 590.510 apply to this section. tained from the National Supervisor (j) The contents of any cup or other for other mechanical devices. liquid egg receptacle containing one or (i) A separate drawoff room with a more inedible or loss eggs shall be re- filtered positive air ventilation system jected. shall be provided for packaging liquid (k) Contents of drip trays shall be emptied into a cup and smelled care- egg product, except product packaged fully before pouring into liquid egg

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bucket. Drip trays shall be emptied at shall be cleaned and sanitized each least once for each 15 dozen eggs or time it is necessary to change such every 15 minutes. equipment, but at least once each 4 (l) Edible leakers as defined in hours of operation. § 590.510(c)(2) and checks which are lia- (w) Breaking room processing equip- ble to be smashed in the breaking oper- ment shall not be stored on the floor. ation shall be broken at a separate sta- (x) Metal containers and lids for tion by specially trained personnel. other than dried products shall be thor- (m) Ingredients and additives used in, oughly washed, rinsed, sanitized, and or for, processing egg products, shall be drained immediately prior to filling. handled in a clean and sanitary man- The foregoing sequence shall not be re- ner. quired if equally effective measures ap- (n) Liquid egg containers shall not proved by the National Supervisor in pass through the candling room. writing are followed to assure clean (o) Test kits shall be provided and and sanitary containers at the time of used to determine the strength of the filling. sanitizing solution. (See §§ 590.515(a)(9) (y) Liquid egg holding vats and con- and 590.552.) tainers (including tank trucks) used for (p) Leaker trays shall be washed and transporting liquid eggs shall be sanitized whenever they become soiled cleaned after each use. Such equipment and at the end of each shift. shall be clean and sanitized imme- (q) Shell egg containers whenever diately prior to placing in use. dirty shall be cleaned and drained; and shall be cleaned, sanitized, and drained (z) Tables, shell conveyors, and con- at the end of each shift. tainers for inedible egg product shall (r) Belt-type shell egg conveyors be cleaned at the end of each shift. shall be cleaned and sanitized approxi- (aa) Mechanical egg breaking ma- mately every 4 hours in addition to chines shall be operated at a rate to continuous cleaning during operation. maintain complete control and accu- When not in use, belts shall be raised rately inspect and segregate each egg to permit air drying. to insure the removal of all loss and in- (s) Cups, knives, racks, separators, edible eggs. The machine shall be oper- trays, spoons, liquid egg pails, and ated in a sanitary manner. other breaking equipment, except for (1) When an inedible egg is encoun- mechanical egg breaking equipment, tered on mechanical egg breaking shall be cleaned and sanitized at least equipment, the inedible egg and con- every 21⁄2 hours. This equipment shall taminated liquid shall be removed. The be cleaned at the end of each shift and machine shall be cleaned and sanitized, shall be clean and sanitized imme- or contaminated parts replaced with diately prior to use. clean ones in the manner prescribed by (t) Utensils and dismantled equip- the Administrator for the type of ined- ment shall be drained and air dried on ible egg encountered and the kind of approved self-draining metal racks and egg breaking machine. shall not be nested. (2) Systems for pumping egg liquid (u) Dump tanks, drawoff tanks, and directly from egg breaking machines churns shall be cleaned approximately shall be of approved sanitary design every 4 hours. All such equipment and and construction, and designed to min- all other liquid handling equipment, imize the entrance of shells into the unless cleaned by acceptable cleaned system and be disconnected when ined- in-place methods, shall be dismantled ible eggs are encountered. The pipe- and cleaned after each shift. Pasteur- lines of the pumping system shall be ization equipment shall be cleaned at cleaned or flushed as often as needed to the end of each day’s use or more often maintain them in a sanitary condition, if necessary. All such equipment shall and they shall be cleaned and sanitized be clean and shall be sanitized prior to at the end of each shift. Other pumping placing in use. system equipment shall be cleaned and (v) Strainers, clarifiers, filtering and sanitized approximately every 4 hours other devices used for removal of shell or as often as needed to maintain it in particles and other foreign material a sanitary condition. All liquid egg

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pumped directly from egg breaking ma- § 590.530 Liquid egg cooling. chines shall be reexamined, except as (a) Liquid egg storage rooms, includ- otherwise prescribed and approved by ing surface coolers and holding tank the Administrator. rooms, shall be kept clean and free (3) Mechanical egg breaking equip- from objectionable odors and condensa- ment shall be clean and sanitized prior tion. Surface coolers and liquid holding to use, and during operations the ma- vats containing product shall be kept chines shall be cleaned and sanitized covered while in use. Liquid cooling approximately every 4 hours or more units shall be of approved construction often if needed to maintain them in a and have sufficient capacity to cool all sanitary condition. This equipment liquid eggs to the temperature require- shall be cleaned at the end of each ments specified in this section. shift. (b) Compliance with temperature requirements applying to liquid eggs [36 FR 9814, May 28, 1971, as amended at 37 shall be considered as satisfactory only FR 6659, Apr. 1, 1972; 40 FR 20059, May 8, 1975; if the entire mass of the liquid meets 40 FR 20941, May 14, 1975. Redesignated at 42 the requirements. FR 32514, June 27, 1977, and further redesignated at 46 FR 63203, Dec. 31, 1981] (c) The cooling and temperature requirements for liquid egg products shall be as specified in Table I of this section.

TABLE I—MINIMUM COOLING AND TEMPERATURE REQUIREMENTS FOR LIQUID EGG PRODUCTS [Unpasterurized product temperature within 2 hours from time of breaking]

Liquid (other Liquid (other than salt prod- than salt prod- Temperature Temperature Product uct) to be held uct) to be held Liquid salt within 2 hours within 3 hours 8 hours or in excess of 8 product after pasteur- after stabiliza- less hours ization tion

Whites (not to be stabilized) ...... 55 °F. or lower 45 °F. or lower ...... 45 °F. or lower. Whites (to be stabilized) ...... 70 °F. or lower 55 °F. or lower ...... 55 °F. or lower (1) All other product (except product with 10 45 °F. or lower 40 °F. or lower ...... If to be held 8 If to be held 8 percent or more salt added). hours or hours or less 45 °F. less, 45 °F. or lower. If or lower. If to be held in to be held in excess of 8 excess of 8 hours, 40 hours, 40 °F. or lower. °F. or lower. Liquid egg product with 10 percent or ...... If to be held 65 °F. or more salt added. 30 hours or lower 2. less, 65 °F. or lower. If to be held in excess of 30 hours, 45 °F. or lower. 1 Stabilized liquid whites shall be dried as soon as possible after removal of glucose. The storage of stabilized liquid whites shall be limited to that necessary to provide a continuous operation. 2 The cooling process shall be continued to assure that any salt product to be held in excess of 24 hours is cooled and maintained at 45 °F. or lower.

(d) Upon written request and under into the egg meat, the source of the ice such conditions as may be prescribed must be certified by the local or State by the National Supervisor, liquid cool- board of health. Such liquid shall be ing and holding temperatures not oth- dried. All ice shall be handled in a sani- erwise provided for in this section may tary manner. be approved. (g) Previously frozen egg or egg prod- (e) Agitators shall be operated in uct cannot be added to liquid product such a manner as will minimize foaming. (f) When ice is used as an emergency refrigerant by being placed directly

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for the purpose of complying with liq- (3) The temperature of the products uid cooling requirements. not solidly frozen shall be taken at the center of the container to determine [36 FR 9814, May 28, 1971. Redesignated at 42 FR 32514, June 27, 1977 and further redesig- compliance with this section. nated at 46 FR 63203, Dec. 31, 1981, as amend- (c) Containers shall be stacked so as ed at 47 FR 745, Jan. 7, 1982; 60 FR 49170, Sept. to permit circulation of air around the 21, 1995] containers. (d) The outside of liquid egg con- § 590.532 Liquid egg holding. tainers shall be clean and free from (a) Tanks and vats used for holding evidence of liquid egg. liquid eggs shall be of approved con- (e) Frozen egg products shall be ex- struction, fitted with covers, and lo- amined by organoleptic examination cated in rooms maintained in a sani- after freezing to determine their fit- tary condition. Notwithstanding the ness for human food. Any such prod- foregoing, tanks designed for installa- ucts which are found to be unfit for tion partially outside of a room or human food shall be denatured and any building are acceptable, providing all official identification mark which ap- openings into the tanks terminate in pears on any container thereof shall be the processing room. removed or completely obliterated and (b) Liquid egg holding tanks or vats the containers identified as required in shall be equipped with suitable ther- §§ 590.840 and 590.860. mometers and agitators. § 590.538 Defrosting facilities. (c) Inlets to holding tanks or vats shall be such as to prevent excessive (a) Approved metal defrosting tanks foaming. or vats constructed so as to permit (d) Gaskets, if used, shall be of a san- ready and thorough cleaning shall be itary type. provided. (b) Frozen egg crushers, when used, [36 FR 9814, May 28, 1971. Redesignated at 42 shall be of approved metal construc- FR 32514, June 27, 1977, as amended at 45 FR tion. The crushers shall permit ready 23641, Apr. 8, 1980. Redesignated at 46 FR and thorough cleaning and the bearings 63203, Dec. 31, 1981] and housing shall be fabricated in such § 590.534 Freezing facilities. a manner as to prevent contamination of the egg products. (a) Freezing rooms, either on or off (c) Service tables shall be of approved the premises, shall be capable of freez- metal construction without open seams ing all liquid egg products in accord- and the surfaces shall be smooth to ance with the freezing requirements as allow thorough cleaning. set forth in § 590.536. Use of off-premise freezing facilities is permitted only § 590.539 Defrosting operations. when prior approval in writing from (a) Frozen egg products which are to the National Supervisor is on file. be defrosted shall be defrosted in a san- (b) Adequate air circulation shall be itary manner. provided in all freezing rooms. (b) Each container of frozen eggs shall be checked for condition and odor § 590.536 Freezing operations. just prior to being emptied into the (a) Freezing rooms shall be kept crusher or receiving tank. Frozen eggs clean and free from objectionable which have objectionable odors and are odors. unfit for human food (e.g., sour, musty, (b) Requirements. (1) Nonpasteurized fermented, or decomposed odors) shall egg products which are to be frozen be denatured. shall be solidly frozen or reduced to a (c) Frozen whites to be used in the temperature of 10 °F or lower within 60 production of dried albumen may be hours from time of breaking. defrosted at room temperature. All (2) Pasteurized egg products which other whites shall be defrosted in ac- are to be frozen shall be solidly frozen cordance with paragraph (d) of this sec- or reduced to a temperature of 10 °F or tion. lower within 60 hours from time of pas- (d) Frozen whole eggs, whites and teurization. yolks, and yolks may be tempered or

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partially defrosted for not to exceed 48 shall be equipped with approved air fil- hours at a room temperature no higher ters at blower intake. than 40 °F. or not to exceed 24 hours at (f) High-pressure pump heads and a room temperature above 40 °F.: Pro- lines shall be of stainless steel con- vided, That no portion of the defrosted struction or equivalent which will liquid shall exceed 50 °F. while in or allow for thorough cleaning. out of the container. (g) Preheating units, if used, shall be (1) Frozen eggs packed in metal or of stainless steel construction, or plastic containers may be placed in equivalent which will allow thorough running tap water (70 F° or lower) cleaning. without submersion to speed (h) Powder conveying equipment defrosting. shall be so constructed as will facili- (2) The defrosted liquid shall be held tate thorough cleaning. at 40 °F. or less, except for product to (i) Sifters shall be constructed of an be pasteurized or stabilized by glucose approved metal or metal lined interior. removal as provided in § 590.530. De- The sifting screens and frames shall be frosted liquid shall not be held more of an approved metal construction. than 16 hours prior to processing or Sifters shall be so constructed that ac- drying. cumulations of large particles or lumps (e) Sanitary methods shall be used in of dried eggs can be removed continu- handling containers and removing egg ously while the sifters are in operation. product. [36 FR 9814, May 28, 1971; 36 FR 10841, June 4, (f) Crushers and other equipment 1971. Redesignated at 42 FR 32514, June 27, used in defrosting operations shall be 1977, and further redesignated at 46 FR 63203, dismantled at the end of each shift and Dec. 31, 1981] shall be washed, rinsed, and sanitized. (1) Where crushers are used intermit- § 590.542 Spray process drying oper- tently, they shall be flushed after each ations. use and again before being placed in (a) The drying room shall be kept in use. a clean condition and free of flies, in- (2) Floors and work tables shall be sects, and rodents. kept clean. (b) Low-pressure lines, high-pressure lines, high- and low-pressure pumps, [36 FR 9814, May 28, 1971. Redesignated at 42 FR 32514, June 27, 1977, as amended at 43 FR homogenizers, and pasteurizers shall be 60138, Dec. 26, 1978. Redesignated at 46 FR cleaned by acceptable inplace cleaning 63203, Dec. 31, 1981, as amended at 60 FR methods or dismantled and cleaned 49170, Sept. 21, 1995] after use or as necessary when operations have been interrupted. § 590.540 Spray process drying facili- (1) Spray nozzles, orifices, cores, or ties. whizzers shall be cleaned immediately (a) Driers shall be of a continuous after cessation of drying operations. discharge type and so constructed and (2) Equipment shall be sanitized equipped to prevent an excess accumu- within 2 hours prior to resuming oper- lation of powder in the drier, bags, and ations. powder conveyors. (c) Drying units, conveyors, sifters, (b) Driers shall be of approved con- and packaging systems shall be cleaned struction and materials, with welded whenever wet powder is encountered or seams, and the surfaces shall be when other conditions occur which smooth to allow for thorough cleaning. would adversely affect the product. The (c) Driers shall be equipped with ap- complete drying unit, including sifters, proved air intake filters. conveyors, and powder coolers shall be (d) Air shall be drawn into the drier either wet washed or dry cleaned. A from sources free from foul odors, dust, combination of wet washing and dry and dirt. cleaning of the complete drying unit (e) Indirect heat or the use of an ap- shall not be permitted unless that seg- proved premixing device or other ap- ment of the unit to be cleaned in a dif- proved devices for securing complete ferent manner is completely detached combustion in direct-fired units is re- or disconnected from the balance of the quired. A premix-type burner, if used, drying unit.

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(1) Sifters and conveyors used for practices and such procedures as may other than dried albumen shall be be prescribed by the Administrator. cleared of powder when such equipment (d) Any edible dried egg powder may is not to be used for a period of 24 hours be reconstituted, repasteurized, and or longer. redried when accomplished in a clean, (2) Collector bags shall be cleaned as sanitary manner and in accordance often as needed to maintain them in an with such procedures as may be pre- acceptable clean condition. scribed by the Administrator. (d) Powder shall be sifted and the (e) Edible dried egg powder obtained screen shall be replaced whenever torn from the sweep down, screenings, brush or worn. bag (except for brush bag powder from (e) Accumulations of large particles albumen driers), and improperly dried or lumps of dried eggs shall be removed or scorched powder shall be reconsti- from the sifter screens continuously. tuted, repasteurized, and redried. (f) All openings into the drier around (f) Approximately the first and last ports, augers, high-pressure lines, etc., 175 pounds of powder from the main shall be closed to the extent possible driers for each continuous operation during the drying operation to prevent shall be checked for improperly dried entrance of nonfiltered air. or scorched powder. (g) Openings into the drying unit § 590.546 Albumen flake process dry- shall be closed when the drier is not in ing facilities. use, except when the drying unit has been completely emptied of powder and (a) Drying facilities shall be con- wet washed. This includes, but is not structed in such a manner as will allow limited to, openings, for the air intake thorough cleaning and be equipped and exhaust systems, nozzle openings, with approved intake filters. ports, augers, etc. (b) The intake air source shall be free from foul odors, dust, and dirt. § 590.544 Spray process powder; defini- (c) Premix-type burners, if used, shall tions and requirements. be equipped with approved air filters at blower intake. (a) Definition of product: (d) Fermentation tanks, drying pans, (1) Primary powder is that powder trays or belts, scrapers, curing racks, which is continuously removed from and equipment used for pulverizing pan the primary or main drying chamber dried albumen shall be constructed of while the drying unit is in operation. approved materials in such a manner (2) Secondary powder is that powder as will permit thorough cleaning. which is continuously and automati- (e) Sifting screens shall be con- cally removed from the secondary structed of approved materials in such chamber and/or bag collector chamber a manner as will permit thorough while the drying unit is in operation. cleaning and be in accordance with the (3) Sweep-down powder is that powder specification for the type of albumen which is recovered in the brush-down produced. process from the primary or secondary chamber and conveyors. § 590.547 Albumen flake process dry- (4) Brush bag powder is that powder ing operations. which is brushed from the collector (a) The fermentation, drying, and bags. curing rooms shall be kept in a dust- (b) Secondary powder shall be con- free clean condition and free of flies, tinuously discharged and mixed with insects, and rodents. the primary powder by methods ap- (b) Drying units, racks, and trucks proved by the Administrator. shall be kept in a clean and sanitary (c) Edible dried egg products, includ- condition. ing edible ingredients which may be (c) Drying pans, trays, belts, scrap- added to such dried products, may be ers, or curing racks, if used, shall be dry-blended: Provided, That the blend- kept in a clean condition. ing is done in a room as provided in (d) Oils and waxes used in oiling dry- § 590.548 or in a closed blending system ing pans or trays shall be of edible and in accordance with clean, sanitary quality.

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(e) Equipment used for pulverizing or sanitary cabinets or racks provided for sifting dried albumen shall be kept in a this purpose. clean condition. (5) Automatic container fillers shall be of a type that will accurately fill § 590.548 Drying, blending, packaging, given quantities of product into the and heat treatment rooms and fa- containers. Scales shall be provided to cilities. accurately check the weight of the (a) General. Processing rooms shall be filled containers. All equipment used in maintained in a clean condition and mechanically packaging dried egg free of flies, insects, and rodents. The products shall be vacuum cleaned drying, blending, and packaging rooms daily. shall be well-lighted and have ceilings (c) The heat treatment room shall be and walls of a tile surface, enamel of an approved construction and be paint, or other water-resistant mate- maintained in a clean condition. The rial. room or rooms shall be of sufficient (1) The floors shall be free from size so that product to be heat treated cracks or rough surfaces where water can be so spaced to assure adequate or dirt could accumulate. heat and air circulation. The room (2) The intersections of the walls and shall have an adequate heat supply and floors shall be impervious to water and a continuous air circulation system. the floor shall be sloped for adequate § 590.549 Dried egg storage. drainage. (3) Metal storage racks or cabinets Dried egg storage shall be sufficient to adequately handle the production of shall be provided for storing of tools the plant and shall be kept clean, dry, and accessories. and free from objectionable odors. (b) Dry blending of edible egg products, including adding edible dry ingre- § 590.550 Washing and sanitizing room dients, and/or packaging of spray-dried or area facilities. products shall be done in a room sepa- (a) This room or area shall be well rate from other processing operations. lighted, and of sufficient size to permit Dry blending may also be done in other operators to properly wash and sanitize areas: Provided, That it is accomplished all equipment at the rate required by in an approved closed blending system. the size of the operation. Adequate ex- (1) Blending and packaging rooms for haust shall be provided to assure the pasteurized products shall be provided prompt removal of odors and vapors with an adequate positive flow of ap- and the air flow shall be away from the proved outside filtered air. breaking room. If the washing and (2) Blending and packaging equip- sanitizing is not done in a separate ment and accessories which come into room, it shall be in an area well seg- contact with the dried product shall be regated from the breaking areas and be of an approved construction without well ventilated with air movement di- open seams and of materials that can rected away from the breaking oper- be kept clean and which will have no ations so that odors and vapors do not deleterious effect on the product. Serv- permeate the breaking areas. ice tables shall be of approved metal (b) Ceiling and walls shall have a sur- construction without open seams and face of tile, enamel paint, or other surfaces shall be smooth to permit water-resistant material. thorough cleaning. (c) Floors shall be adequately sloped (3) Package liners shall be inserted in for proper drainage, be free from a sanitary manner, and equipment and cracks or rough surfaces where water supplies used in the operation shall be and dirt could accumulate and the kept off the floor. intersections with walls shall be imper- (4) Utensils used in packaging dried vious to water. eggs shall be kept clean at all times and whenever contaminated shall be § 590.552 Cleaning and sanitizing re- cleaned and sanitized. When not in use, quirements. scoops, brushes, tampers, and other (a) Cleaning. (1) Equipment used in similar equipment shall be stored in egg processing operations which comes

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in contact with liquid eggs or exposed rooms shall be adequate and meet edible products shall be cleaned to State and local requirements for food eliminate organic matter and inor- processing plants. ganic residues. This may be accom- (b) Toilets and dressing rooms shall plished by any sanitary means but it is be kept clean and adequately venti- preferable (unless high pressure clean- lated to eliminate odors and kept ade- ing is used) to flush soiled equipment quately supplied with soap, towels, and with clean cool water, dismantle it tissues. Toilet rooms shall be venti- when possible, wash by brushing with lated to the outside of the building. warm water containing a detergent and (c) No person affected with any com- followed by rinsing with water. It is es- municable disease in a transmissible sential to have the equipment surfaces stage or a carrier of such disease, or thoroughly clean if effective sanitizing with boils, sores, infected wounds, or is to be attained. wearing cloth bandages on hands shall (2) Equipment shall be cleaned with be permitted to come in contact with such frequency as is specified else- eggs in any form or with equipment where under the sanitary requirements used to process such eggs. for the particular kind of operation and (d) Workers coming into contact with type of equipment involved. liquid or dried eggs, containers, or (3) C.I.P. (cleaned-in-place) shall be equipment shall wear clean outer uni- considered to be acceptable only if the forms. methods and procedures used accom- (e) Plant personnel handling exposed plish cleaning equivalent to that ob- edible product shall wash their hands tained by thorough manual washing before beginning work, and upon re- and sanitizing of dismantled equip- turning to work after leaving the work ment. The Administrator shall deter- room. mine the acceptability of C.I.P. clean- (f) Expectorating, or other unsani- ing procedures and may require bac- tary practices, shall not be permitted. teriological tests and periodic disman- (g) Use of tobacco in any form or the tling of equipment as a basis for such wearing of jewelry, nail polish, or per- determination. fumes shall not be permitted in any (b) Sanitizing. (1) Sanitizing shall be area where edible products are exposed. accomplished by such methods as ap- (h) Hair nets or caps shall be properly proved by the Administrator. worn by all persons in breaking and (i) Chemicals and compounds used for packaging rooms. sanitizing shall have approval by the Administrator prior to use. § 590.570 Pasteurization of liquid eggs. (ii) Sanitizing by use of hypochlorites (a) Pasteurization facilities: The fa- or other approved sanitizing solutions cilities for pasteurization of egg prod- shall be accomplished by subjecting ucts shall be adequate and of approved the equipment surfaces to such sani- construction so that all products will tizing solution containing a maximum be processed as provided for in this sec- strength of 200 p.p.m. of available chlo- tion. Pasteurization equipment for liq- rine or its equivalent. These solutions uid egg product shall include a holding shall be changed whenever the strength tube, an automatic flow diversion drops to 100 p.p.m. or less of available valve, thermal controls, and recording chlorine or its equivalent. devices to determine compliance for (2) Shell eggs which have been sani- pasteurization as set forth in para- tized and equipment which comes in graph (b) of this section. The tempera- contact with edible products shall be ture of the heated liquid egg product rinsed with clean water after sanitizing shall be continuously and automati- if other than hypochlorites are used as cally recorded during the process. sanitizing agents unless otherwise ap- (b) Pasteurizing operations: Every proved by the Administrator. particle of all products must be rapidly heated to the required temperature and § 590.560 Health and hygiene of per- held at that temperature for the re- sonnel. quired minimum holding time as set (a) Personnel facilities, including toi- forth in this section. The temperatures lets, lavatories, lockers, and dressing and holding times listed in Table I of

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this section are minimum. The product the lot number or production code may be heated to higher temperatures number. and held for longer periods of time. (b) The minimum requirements for Pasteurization procedures shall assure heat treatment of spray or pan dried complete pasteurization, and holding, albumen shall be as follows: packaging, facilities and operations (1) Spray dried albumen shall be shall be such as to prevent contamina- heated throughout to a temperature tion of the product. not less than 130 °F and held continuously at such temperature not less TABLE I—PASTEURIZATION REQUIREMENTS 1 than 7 days and until it is salmonella negative. Minimum Minimum tempera- holding (2) Pan dried albumen shall be heated Liquid egg product ture re- time re- throughout to a temperature of not quire- quire- ° ments ments less than 125 F and held continuously (°F.) (Minutes) at such temperature not less than 5 days and until it is salmonella nega- Albumen (without use of chemicals) 134 3.5 132 6.2 tive. Whole egg ...... 140 3.5 (3) Methods of heat treatment of Whole egg blends (less than 2 per- spray dried or pan dried albumen, other cent added nonegg ingredients) .... 142 3.5 than listed in paragraphs (b) (1) and (2) 140 6.2 Fortified whole egg and blends (24– of this section, may be approved by the 38 percent egg solids, 2–12 per- Administrator upon receipt of satisfac- cent added nonegg ingredients) .... 144 3.5 tory evidence that such methods will 142 6.2 result in salmonella negative products. Salt whole egg (with 2 percent or more salt added) ...... 146 3.5 (c) Dried whites which have been 144 6.2 heat treated in the dried form shall be Sugar whole egg (2–12 percent sampled and analyzed for the presence sugar added) ...... 142 3.5 of Salmonellae as required in § 590.580. 140 6.2 Plain yolk ...... 142 3.5 (d) Records shall be maintained for 1 140 6.2 year of the following: Sugar yolk (2 percent or more sugar (1) Types of product; added) ...... 146 3.5 (2) Lot number; 144 6.2 Salt yolk (2–12 percent salt added) .. 146 3.5 (3) Heat treatment room tempera- 144 6.2 tures; 1 Pasteurization of egg products not listed in this table shall (4) Product temperatures; be in accordance with paragraph (c) of this section. (5) Length of time product is held in heat treatment room; (c) Other methods of pasteurization (6) Results of all laboratory analyses may be approved by the Administrator made for the presence of Salmonellae. when such treatments give equivalent (e) Dried whites processed and tested effects to those specified in paragraph in accordance with all of the applicable (b) of this section for those products or requirements specified in this section other products and results in a sal- may be labeled ‘‘Pasteurized.’’ monella negative product. [36 FR 9814, May 28, 1971. Redesignated at 42 § 590.575 Heat treatment of dried FR 32514, June 27, 1977, and further redesig- whites. nated at 46 FR 63203, Dec. 31, 1981, as amended at 47 FR 745, Jan. 7, 1982; 60 FR 49169, Sept. Heat treatment of dried whites is an 21, 1995; 60 FR 58199, Nov. 27, 1995] approved method for pasteurization and the product shall be heated LABORATORY throughout for such times and at such temperatures as will result in sal- § 590.580 Laboratory tests and anal- monella negative product. yses. (a) The product to be heat treated The official plant, at their expense, shall be held in the heat treatment shall make tests and analyses to deter- room in closed containers and shall be mine compliance with the Act and the spaced to assure adequate heat pene- regulations. tration and air circulation. Each con- (a) Samples shall be drawn from liq- tainer shall be identified as to type of uid, frozen or dried egg products and product (spray or pan dried) and with analyzed for compliance with the

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standards of identity (if any) and with ject to other provisions applicable to the product label. official plants which shall include (b) To assure adequate pasteuriza- maintaining records such as pasteur- tion, pasteurized egg products and heat ization temperatures and holding treated dried egg whites shall be sam- times, laboratory records, egg products pled and analyzed for the presence of testing procedures, and making all Salmonellae in accordance with such such records available for review. sequence, frequency, and approved lab- (b) The eggs received or used in the oratory methods as prescribed by the manufacture of egg products contain AMS Science Division Director. The no more restricted eggs than are al- samples of pasteurized egg products lowed by the official standards for U.S. and heat treated dried egg whites shall Consumer Grade B shell eggs. be drawn from the final packaged form. [36 FR 9814, May 28, 1971. Redesignated at 42 (c) Results of all analyses and tests FR 32514, June 27, 1977, and further redesig- performed under paragraphs (a) and (b) nated at 46 FR 63203, Dec. 31, 1981, as amend- of this section shall be provided to the ed at 47 FR 745, Jan. 7, 1982] inspector promptly upon receipt by the plant. If samples of pasteurized prod- § 590.620 Authority of applicant. ucts or heat treated dried egg whites, Proof of authority of any person ap- in addition to those described in para- plying for exemption from continuous graphs (a) and (b) of this section, are inspection may be required by the Ad- analyzed for the presence of Sal- ministrator. monella, the plant shall immediately advise the inspector of any such sam- § 590.630 Filing of application. ples which are determined to be Sal- An application for exemption shall be monella positive. regarded as filed only when it has been (d) USDA will draw confirmation filled in completely and signed by the samples and submit them to a AMS applicant and has been received in the Science Division laboratory at USDA’s office of the inspection service. expense to determine the adequacy of the plant’s tests and analyses. § 590.640 Application for exemption; approval. [36 FR 9814, May 28, 1971. Redesignated at 42 FR 32514, June 27, 1977, and further redesig- Any person desiring to process egg nated at 46 FR 63203, Dec. 31, 1981, as amend- products pursuant to the exemption ed at 58 FR 42413, Aug. 9, 1993; 60 FR 49170, provision of the Act and these regula- Sept. 21, 1995; 60 FR 58199, Nov. 27, 1995] tions must receive approval of such plant, facilities, and operating proce- EXEMPTED EGG PRODUCTS PLANTS dures as an exempted plant. An application for exemption shall be according § 590.600 Application for exemption. to the following: An application for exemption from (a) Initial survey. When an application the continuous inspection require- for exemption of a plant has been filed, ments must be made in writing on a Supervisory Egg Products Inspector forms approved by the Administrator will make a survey and inspection of and filed with the inspection service. the premises and plant to determine if [36 FR 9814, May 28, 1971. Redesignated at 42 the facilities, methods of operation, FR 32514, June 27, 1977, and further redesig- and eggs received or used therein are nated at 46 FR 63203, Dec. 31, 1981, as amend- suitable and adequate in accordance ed at 47 FR 745, Jan. 7, 1982] with: (1) Section 590.610; and § 590.610 Criteria for exemption. (2) Such other administrative in- Any plant processing egg products structions as may be issued, from time may qualify for exemption where: to time, by the Service and which are (a) The facility, operating procedures in effect at the time of the aforesaid and practices, and sanitation meet the survey and inspection. standards required for official egg (b) Final survey and exemption ap- products plants as are contained in proval. Upon notification by the appli- §§ 590.500 through 590.580, and such ex- cant for exemption that all the criteria empted plants shall thereafter be sub- for exemption required in § 590.610 are

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in effect and an initial survey has been § 590.680 Approval of labeling for egg performed, the applicant shall: products processed in exempted (1) Submit drawings and specifica- egg products processing plants. tions in accordance with the same re- (a) The labels for egg products which quirements as official plants as speci- are capable for use as human food shall fied in § 590.146(b); be submitted to the Administrator for (2) Submit labels for approval as approval. The submission and approval specified in § 590.680; shall be the same as for official plants (3) Request a final survey be made by as required in § 590.411 except the labels a Supervisory Egg Products Inspector or containers shall not bear official to determine if the plant is constructed identification. and the facilities are installed in ac- (b) The label or container shall leg- cordance with the approved drawings ibly and conspicuously bear the state- and these regulations. ment: ‘‘Exempted—E.P.I.A. Registra- (c) The plant will be approved for ex- tion No. lll.’’ The registration num- emption only when all the require- ber shall be that assigned to the ex- ments of this section have been met. empted plant as provided in § 590.650.

[36 FR 9814, May 28, 1971; 36 FR 10841, June 4, IDENTIFICATION OF RESTRICTED EGGS OR 1971. Redesignated at 42 FR 32514, June 27, EGG PRODUCTS NOT INTENDED FOR 1977, and further redesignated at 46 FR 63203, HUMAN CONSUMPTION Dec. 31, 1981]

§ 590.650 Exempted plant registration § 590.800 Identification of restricted number. eggs. Each plant processing egg products The shipping container of restricted which receives the Administrator’s ap- eggs shall be determined to be satisfac- torily identified if such container bears proval for exemption shall be assigned the packer’s name and address, the an ‘‘Exempted Registration Number’’ quality of the eggs in the container at the time the exemption approval is (e.g., dirties, checks, inedibles, or loss), provided. or the statement ‘‘Restricted Eggs— § 590.660 Inspection of exempted For Processing Only In An Official plants. USDA Egg Products Plant,’’ for checks or dirties, or ‘‘Restricted Eggs—Not To Duly authorized representatives of Be Used As Human Food,’’ for the Administrator shall make such inedibles, loss, and incubator rejects, periodic inspections of exempted plants or ‘‘Restricted Eggs—To Be Regraded’’ and records thereof as the Adminis- for graded eggs which contain more re- trator may require to ascertain if any stricted eggs than are allowed in the of the provisions of the Act or these official standards for U.S. Consumer regulations applicable to exempted Grade B shell eggs. The size of the let- plants have been violated. Such rep- ters of the identification wording shall resentatives shall be afforded access, at be as required in § 590.860. any reasonable time, to any plant or place of business subject to inspection [40 FR 20060, May 8, 1975. Redesignated at 42 under the provisions of the Act. FR 32514, June 27, 1977, and further redesignated at 46 FR 63203, Dec. 31, 1981, as amend- § 590.670 Termination of exemption. ed at 60 FR 49171, Sept. 21, 1995; 63 FR 69972, Dec. 17, 1998] The Administrator may suspend or terminate any exemption if the cri- § 590.840 Identification of inedible, un- teria for exemption required in § 590.610 wholesome, or adulterated egg are not being met. In addition, if any products. violation has been committed, the ap- All inedible, unwholesome, or adul- plicable penalties provided in this part terated egg products shall be identified may be enforced as provided in the Act. with the name and address of the processor, the words ‘‘Inedible Egg Prod- ucts—Not To Be Used as Human Food.’’

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§ 590.860 Identification wording. and controlled upon arrival at the destination breaking plant. The letters of the identification wording shall be legible and con- [36 FR 9814, May 28, 1971, as amended at 37 spicuous. FR 6659, Apr. 1, 1972. Redesignated at 42 FR 32514, June 27, 1977, and further redesignated [37 FR 6659, Apr. 1, 1972. Redesignated at 42 at 46 FR 63203, Dec. 31, 1981, as amended at 60 FR 32514, June 27, 1977, and further redesig- FR 49171, Sept. 21, 1995; 63 FR 69972, Dec. 17, nated at 46 FR 63203, Dec. 31, 1981] 1998]

IMPORTS § 590.910 Eligibility of foreign countries for importation of egg prod- § 590.900 Requirements for importa- ucts into the United States. tion of egg products or restricted (a) Whenever it is determined by the eggs into the United States. Administrator that the system of egg (a) Egg products and restricted eggs products inspection maintained by any may be imported into the United foreign country is such that the egg States from any foreign country only products produced in such country are in accordance with these regulations. processed, labeled, and packaged in ac- The term United States means any cordance with, and otherwise comply State of the United States, the Com- with, the standards of the Act and monwealth of Puerto Rico, the Virgin these regulations including, but not Islands of the United States, and the limited to the same sanitary, proc- District of Columbia. The importation essing, facility requirements, and con- of any egg or egg product in violation tinuous Government inspection as re- of the regulations of this part is pro- quired in §§ 590.500 through 590.580 ap- hibited. plicable to inspected articles produced (b) All such imported articles shall within the United States, notice of that fact will be given by listing the upon entry into the United States be name of such foreign country in para- deemed and treated as domestic arti- graph (b) of this section. Thereafter, cles and be subject to the other provi- egg products from the countries so list- sions of the Act, these regulations, and ed shall be eligible, subject to the pro- other Federal or State requirements. visions of this part and other applicable laws and regulations, for importa- § 590.905 Importation of restricted eggs or eggs containing more re- tion into the United States. Such prod- stricted eggs than permitted in the ucts to be imported into the United official standards for U.S. Con- States from these foreign countries sumer Grade B. must meet, to the extent applicable, the same standards and requirements No containers of restricted egg(s) that apply to comparable domestic other than checks or dirties shall be products as set forth in these regula- imported into the United States. The tions. Egg products from foreign coun- shipping containers of such eggs shall tries not listed herein are not eligible be identified with the name, address, for importation into the United States, and country of origin of the exporter, except as provided by § 590.960. In deter- and the date of pack and quality of the mining if the inspection system of a eggs (e.g., checks, or dirties) preceded foreign country is the equivalent of the by the word ‘‘Imported’’ or the state- system maintained by the United ment ‘‘Imported Restricted Eggs—For States, the Administrator shall review Processing Only In An Official USDA the inspection regulations of the for- Plant,’’ or ‘‘Restricted Eggs—Not To eign country and make a survey to de- Be Used As Human Food.’’ Such identi- termine the manner in which the in- fication shall be legible and con- spection system is administered within spicuous. Alternatively, for properly the foreign country. The survey of the sealed and certified shipments of shell foreign inspection system may be expe- eggs imported for breaking at an offi- dited by payment by the interested cial egg products plant, the shipping Government agency in the foreign containers need not be labeled, pro- country of the travel expenses incurred vided that the shipment is segregated in making the survey. After approval

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of the inspection system of a foreign § 590.920 Importer to make application country, the Administrator may, as for inspection of imported eggs and often and to the extent deemed nec- egg products. essary, authorize representatives of the Each person importing any eggs or Department to review the system to egg products shall make application determine that it is maintained in such for inspection to the Chief, Poultry a manner as to be the equivalent of the Grading Branch, Poultry Division, Ag- system maintained by the United ricultural Marketing Service, U.S. De- States. partment of Agriculture, Washington, (b) It has been determined that each DC 20250, or to the Poultry Division, of the following foreign countries Poultry Grading Branch office at the maintain an egg products inspection port where the product is to be offered system that is the equivalent of the for importation. Application shall be system maintained by the United made as long as possible prior to the States: Canada, The Netherlands. arrival of each consignment of product, [36 FR 9814, May 28, 1971. Redesignated at 42 except in the case of product exempted FR 32514, June 27, 1977, as amended at 42 FR from inspection by § 590.960. Each appli- 48327, Sept. 23, 1977. Redesignated at 46 FR cation shall state the approximate date 63203, Dec. 31, 1981, as amended at 52 FR of product arrival in the United States, 42426, Nov. 5, 1987] the name of the ship or other carrier, the country from which the product § 590.915 Foreign inspection certification required. was shipped, the destination, the quantity and class of product, whether (a) Except as provided in § 590.960, fresh, frozen, or dried, and the point of each consignment of egg products, as first arrival in the United States. defined in this part, shall be accompanied by a foreign egg products in- [36 FR 9814, May 28, 1971. Redesignated at 42 spection certificate, which, unless oth- FR 32514, June 27, 1977, as amended at 43 FR erwise approved by the Administrator, 60138, Dec. 26, 1978. Redesignated at 46 FR 63203, Dec. 31, 1981, as amended at 47 FR contains the following information: 46070, Oct. 15, 1982; 47 FR 54421, Dec. 3, 1982; (1) Country exporting product; 63 FR 69972, Dec. 17, 1998] (2) City and date where issued; (3) Kind of product, number of con- § 590.925 Inspection of imported egg tainers, and weight; products. (4) Production date(s) of product; (a) Except as provided in § 590.960, egg (5) Identification marks on con- products offered for importation from tainers; any foreign country shall be subject to (6) Name and address of exporter; inspection in accordance with estab- (7) Name, address, and plant number lished inspection procedures, including of processing plant; the examination of the labeling infor- (8) Name and address of importer; mation on the containers, by an inspec- (9) A certification that the egg prod- tor before the product shall be admit- ucts were produced under the approved ted into the United States. Importers regulations, requirements, and contin- will be advised of the point where in- uous Government inspection of the ex- spection will be made, and in case of porting country and; small shipments (less than carload (10) Name (including signature) and lots), the importer may be required to official title of person authorized to move the product to the location of the issue inspection certificates for egg nearest inspector. products exported to the United States. (b) Inspectors may take samples, (b) [Reserved] without cost to the United States, of any product offered for importation [36 FR 9814, May 28, 1971, as amended at 37 which is subject to analysis or quality FR 6659, Apr. 1, 1972. Redesignated at 42 FR 32514, June 27, 1977, and further redesignated determination, except that samples at 46 FR 63203, Dec. 31, 1981, as amended at 60 shall not be taken of any products of- FR 49171, Sept. 21, 1995; 63 FR 45675, Aug. 27, fered for importation under § 590.960, 1998; 63 FR 69972, Dec. 17, 1998] unless there is reason for suspecting

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the presence therein of a substance in (Name of Truck Line or Carrier) violation of that section. NOTICE [36 FR 9814, May 28, 1971. Redesignated at 42 This package of lllll must be deliv- FR 32514, June 27, 1977, and further redesig- ered intact to an inspector of the Poultry Di- nated at 46 FR 63203, Dec. 31, 1981, as amend- vision, U.S. Department of Agriculture. ed at 63 FR 69972, Dec. 17, 1998] WARNING § 590.930 Imported egg products; re- Failure to comply with these instructions tention in customs custody; delivery will result in penalty action being taken under bond; movement prior to in- against the holder of the customs entry spection; sealing; handling; facili- bond. ties, and assistance. If the product is found to be acceptable upon inspection, the product may be released (a) No egg products required by this to the consignee, or his agent, and this warn- part to be inspected shall be released ing notice defaced. from customs custody prior to required inspections, but such product may be (d) No person shall affix, break, alter, delivered to the consignee, or his deface, mutilate, remove, or destroy any special import seal of the U.S. De- agent, prior to inspection if the con- partment of Agriculture, except cus- signee shall furnish a bond, in the form toms officers or inspectors, or as pro- prescribed by the Secretary of the vided in paragraph (f) of this section. Treasury, conditioned that the product (e) No product shall be removed from shall be returned, if demanded, to the any means of conveyance or package collector of the port where the same is sealed with a special import seal of the offered for clearance through customs. U.S. Department of Agriculture, except (b) Notwithstanding paragraph (a) of under the supervision of an inspector this section, no product required by or a customs officer, or as provided in this part to be inspected shall be paragraph (f) of this section. moved prior to inspection from the (f) In case of a wreck or similar export of arrival where first unloaded, traordinary emergency, the special im- and if arriving by water from the wharf port seal of the U.S. Department of Ag- where first unloaded at such port, to riculture on a car, truck, or other any place other than the place des- means of conveyance may be broken by ignated in accordance with this part as the carrier and, if necessary, the arti- the place where the same shall be in- cles may be reloaded into another spected; and no product shall be con- means of conveyance for transpor- veyed in any manner other than in tation to destination. In all such cases, compliance with this part. the carrier shall immediately report (c) Means of conveyance or packages the facts by telegraph to the Chief of in which any product is moved in ac- the Grading Branch. cordance with this part, prior to in- (g) The consignee or his agent shall spection, from the port or wharf where provide such facilities and assistance first unloaded in the United States, as the inspector may require for the in- shall be sealed with special import spection and handling and marking of seals of the U.S. Department of Agri- products offered for importation. culture or otherwise identified as pro- [36 FR 9814, May 28, 1971, as amended at 37 vided herein, unless already sealed FR 6660, Apr. 1, 1972; 40 FR 20060, May 8, 1975. with customs or consular seals in ac- Redesignated at 42 FR 32514, June 27, 1977, as cordance with the customs regulations. amended at 43 FR 60138, Dec. 26, 1978. Redes- Such special seals shall be affixed by ignated at 46 FR 63203, Dec. 31, 1981, as amended at 47 FR 46070, Oct. 15, 1982; 47 FR an inspector or, if there is no inspector 54421, Dec. 3, 1982; 63 FR 69972, Dec. 17, 1998] at such port, by a customs officer. In lieu of sealing packages, the carrier or § 590.935 Means of conveyance and importer may furnish and attach to equipment used in handling egg each package of product a warning no- products to be maintained in sani- tice on bright yellow paper, not less tary condition. than 5×8 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

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States, and all chutes, platforms, has been clearly and legibly marked in racks, tables, tools, utensils, and all compliance with this part. other devices used in moving and han- [36 FR 9814, May 28, 1971, as amended at 37 dling such product offered for importa- FR 6660, Apr. 1, 1972. Redesignated at 42 FR tion, shall be maintained in a sanitary 32514, June 27, 1977, and further redesignated condition. at 46 FR 63203, Dec. 31, 1981, as amended at 60 FR 49171, Sept. 21, 1995; 63 FR 69972, Dec. 17, § 590.940 Marking of egg products of- 1998] fered for importation. § 590.950 Labeling of containers of Egg products which, upon inspection, eggs or egg products for importa- are found to be acceptable for importation. tion into the United States, and are properly labeled and bear the inspec- (a) Immediate containers of product offered for importation shall bear a tion mark of the country of origin, label, printed in English, showing: need no further identification. (1) The name of product; [40 FR 20060, May 8, 1975. Redesignated at 42 (2) the name of the country of origin FR 32514, June 27, 1977, and further redesig- of the product, and for consumer pack- nated at 46 FR 63203, Dec. 31, 1981, as amend- aged products, preceded by the words ed at 60 FR 49171, Sept. 21, 1995] ‘‘Product of,’’ which statement shall appear immediately under the name of § 590.945 Foreign egg products offered the product; for importation; reporting of findings to customs; handling of prod- (3) [Reserved] ucts refused entry. (4) For shell eggs, the words, ‘‘Keep Refrigerated,’’ or words of similar (a) Inspectors shall report their find- meaning; ings to the collector of customs at the (5) for egg products, the word ‘‘Ingre- port where products are offered for dients’’ followed by a list of the ingre- entry, and shall request the collector dients in order of descending propor- to refuse entry to egg products which tions by weight; are marked or designated ‘‘U.S. Re- (6) the name and place of business of fused Entry’’ or otherwise are not in manufacturer, packer, or distributor, compliance with the regulations in this qualified by a phrase which reveals the part. Unless such products are exported connection that such person has with by the consignee within a time speci- the product; fied by the collector of customs (usu- (7) an accurate statement of the ally 30 days), the consignee shall cause quantity; the destruction of such products for (8) for egg products, the inspection human food purposes under the super- mark of the country of origin; and vision of an inspector. If products are (9) The date of production and plant destroyed for human food purposes number of the plant at which the egg under the supervision of an inspector, product was processed and/or packed. he shall give prompt notice thereof to (b) For properly sealed and certified the District Director of Customs. shipments of shell eggs imported for (b) Consignees shall, at their own ex- breaking at an official egg products pense, return immediately to the col- plant, the immediate containers need lector of customs, in means of convey- not be labeled, provided that the ship- ance or packages sealed by the U.S. De- ment is segregated and controlled upon partment of Agriculture, any egg prod- arrival at the destination breaking ucts received by them under this part plant. which in any respect do not comply (c) The labels shall not be false or with this part. misleading in any respect. (c) Except as provided in § 590.930(a), no person shall remove or cause to be [36 FR 9814, May 28, 1971. Redesignated at 42 FR 32514, June 27, 1977, as amended at 45 FR removed from any place designated as 23641, Apr. 8, 1980. Redesignated at 46 FR the place of inspection, any egg prod- 63203, Dec. 31, 1981, as amended at 60 FR ucts which the regulations require to 49171, Sept. 21, 1995; 63 FR 45675, Aug. 27, 1998; be marked in any way, unless the same 63 FR 69972, Dec. 17, 1998]

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§ 590.955 Labeling of shipping con- § 590.960 Small importations for containers of eggs or egg products for signee’s personal use, display, or importation. laboratory analysis. (a) Shipping containers of foreign Any egg products which are offered product which are shipped to the for importation, exclusively for the United States shall bear in a promi- consignee’s personal use, display, or nent and legible manner: laboratory analysis, and not for sale or (1) The common or usual name of the distribution; which is sound, healthful, product; wholesome, and fit for human food; and (2) The name of the country of origin; which is not adulterated and does not (3) The plant number of the plant in contain any substance not permitted which the egg product was processed by the Act or regulations, may be ad- and/or packed; mitted into the United States without (4) The inspection mark of the coun- a foreign inspection certificate. Such try of origin; product is not required to be inspected (5) [Reserved] upon arrival in the United States and (6) For shell eggs, the words ‘‘Keep refrigerated’’ or words of similar mean- may be shipped to the consignee with- ing. out further restriction under this part: (b) Labeling on shipping containers Provided, That the Department may, examined at the time of inspection in with respect to any specific importa- the United States, if found to be false tion, require that the consignee certify or misleading, shall be cause for the that such product is exclusively for the product to be refused entry. consignee’s personal use, display, or (c) [Reserved] laboratory analysis and not for sale or (d) In the case of products which are distribution. The amount of such prod- not in compliance solely because of uct imported shall not exceed 30 misbranding, such products may be pounds of liquid or frozen eggs, or 50 brought into compliance with the regu- pounds of dried egg products, unless lations only under the supervision of otherwise authorized by the Adminis- an authorized representative of the Ad- trator. ministrator. [37 FR 6660, Apr. 1, 1972. Redesignated at 42 [36 FR 9814, May 28, 1971. Redesignated at 42 FR 32514, June 27, 1977, and further redesig- FR 32514, June 27, 1977, and further redesignated at 46 FR 63203, Dec. 31, 1981, as amend- nated at 46 FR 63203, Dec. 31, 1981, as amended at 63 FR 69972, Dec. 17, 1998] ed at 60 FR 49171, Sept. 21, 1995; 63 FR 45675, Aug. 27, 1998; 63 FR 69972, Dec. 17, 1998] § 590.965 Returned U.S. inspected and marked products; not importations. § 590.956 Relabeling of imported egg products. Products which have been inspected (a) Egg products eligible for importa- by the United States Department of tion may be relabeled with an approved Agriculture and so marked, and which label under the supervision of an in- are returned from foreign countries are spector at an official egg products not importations within the meaning plant or other location. The new label of this part. Such returned shipments for such product shall indicate the shall be reported to the Administrator country of origin except for products by letter. which are reprocessed (repasteurized, or in the case of dried products, dry § 590.970 Charges for storage, cartage, blended with products produced in the and labor with respect to products United States) in an official egg prod- imported contrary to the Act. ucts plant. All charges for storage, cartage, and (b) The label for relabeled products labor with respect to any product must state the name, address, and zip which is imported contrary to this part code of the distributor, qualified by an shall be paid by the owner or con- appropriate term such as ‘‘packed for’’, signee, and in default of such payment ‘‘distributed by’’ or ‘‘distributors’’. shall constitute a lien against such [60 FR 49171, Sept. 21, 1995]

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product and any other product there- 592.330 Unauthorized use or disposition of after imported under the Act by or for approved labels. such owner or consignee. 592.340 Supervision of marking and packaging. [36 FR 9814, May 28, 1971. Redesignated at 42 592.350 Accessibility of product. FR 32514, June 27, 1977, and further redesig- 592.360 Certificates. nated at 46 FR 63203, Dec. 31, 1981, as amend- 592.370 Certificate issuance. ed at 47 FR 46071, Oct. 15, 1982; 47 FR 54421, 592.380 Disposition of certificates. Dec. 3, 1982] 592.390 Advance information.

APPEALS PART 592—VOLUNTARY 592.400 Who may request an appeal inspec- INSPECTION OF EGG PRODUCTS tion or review of an inspection program employee’s decision. Sec. 592.410 Where to file an appeal. 592.1 Meaning of words. 592.420 How to file an appeal. 592.2 Terms defined. 592.430 When an application for an appeal 592.5 Designation of official certificates, inspection may be refused. memoranda, marks, other identifica- 592.440 Who shall perform the appeal. tions, and devices for purposes of the Ag- 592.450 Procedures for selecting appeal sam- ricultural Marketing Act. ples. 592.460 Appeal certificates. ADMINISTRATION 592.10 Authority. FEES AND CHARGES 592.500 Payment of fees and charges. GENERAL 592.510 Basetime rate. 592.20 Kinds of services available. 592.520 Overtime rate. 592.22 Where service is offered. 592.530 Holiday rate. 592.24 Basis of service. SANITARY AND PROCESSING REQUIREMENTS PERFORMANCE OF SERVICES 592.600 General. 592.70 Identification. 592.650 Inspection. 592.80 Political activity. AUTHORITY: 7 U.S.C. 1621–1627. 592.90 Authority and duties of inspection program personnel performing service. SOURCE: 69 FR 1648, Jan. 12, 2004, unless 592.95 Facilities and equipment to be fur- otherwise noted. nished for use of inspection program personnel in performing service. DEFINITIONS 592.96 Schedule of operation of official plants. § 592.1 Meaning of words.

APPLICATION FOR SERVICE Under the regulations in this part words in the singular shall be deemed 592.100 Who may obtain service. to import the plural and vice versa, as 592.120 Authority of applicant. 592.130 How application for service may be the case may demand. made. 592.140 Application for inspection in official § 592.2 Terms defined. plants; approval. For the purpose of the regulations in 592.150 When application may be rejected. this part, unless the context otherwise 592.160 When application may be withdrawn. requires, the following terms shall be 592.170 Order of service. 592.180 Suspension of plant approval. construed, respectively: Act means the applicable provisions DENIAL OF SERVICE of the Agricultural Marketing Act of 592.200 Debarment. 1946 (60 Stat. 1087; 7 U.S.C. 1621 et seq.), 592.220 Other applicable regulations. or any other Act of Congress conferring 592.240 Report of violations. like authority. 592.260 Reuse of containers bearing official Administrator means the Adminis- identification prohibited. trator of the Food Safety and Inspec- IDENTIFYING AND MARKING PRODUCTS tion Service (FSIS) of the Department or any other officer or employee of the 592.300 Approval of official identification. 592.310 Form of official identification sym- Department to whom there has been bol and inspection mark. delegated, or to whom there may be 592.320 Products that may bear the inspec- delegated the authority to act in the tion mark. Administrator’s stead.

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Applicant means any interested party Interested party means any person fi- who requests any inspection service, or nancially interested in a transaction appeal inspection, with respect to any involving any inspection or appeal in- product. spection of any product. Class means any subdivision of a Official plant means any plant in product based on essential physical which the facilities and methods of op- characteristics that differentiate be- eration therein have been found by the tween major groups of the same kind, Administrator to be suitable and ade- species, or method of processing. quate for inspection in accordance with Condition means any condition (in- this part and in which such service is cluding, but not being limited to, the carried on. state of preservation, cleanliness, Person means any individual, part- soundness, wholesomeness, or fitness nership, association, business trust, for human food) of any product which corporation, or any organized group of affects its merchantability; or any con- persons, whether incorporated or not. dition, including, but not being limited Product or products means eggs to, the processing, or packaging which (whether liquid, frozen, or dried), egg affects such product. products, and any food product that is Department means the United States prepared or manufactured and contains Department of Agriculture. eggs as an ingredient. District Manager means the manager Program employee means any person in charge of a district, which is a des- employed by the Department or any ignated geographical area. cooperating agency who is authorized Eggs of Current Production means by the Secretary to do any work or shell eggs that have moved through the perform any duty in connection with usual marketing channels since the the program. date of lay and are not in excess of 60 Quality means the inherent prop- days old. erties of any product that determine Holiday or Legal holiday means the its relative degree of excellence. legal public holidays specified by the Regulations mean the provisions in Congress in paragraph (a) of section this part. 6103, Title 5, of the United States Code. Sampling means the act of taking Inspection means the act by inspec- samples of any product for inspection. Secretary means the Secretary of the tion program personnel of: Department or any other officer or em- (1) Determining, according to these ployee of the Department to whom regulations, the class, quality, quan- there has heretofore been delegated, or tity, or condition of any product by ex- to whom there may hereafter be dele- amining each unit thereof or a rep- gated, the authority to act in the Sec- resentative sample drawn by inspection retary’s stead. program personnel; Service means: (1) Any inspection, in (2) Issuing a certificate; or accordance with the Agriculture Mar- (3) Identifying, when requested by keting Act and the regulations in this the applicant, any product by means of part, of any product, official identification pursuant to the (2) Supervision, in any official plant, Act and this part. of the processing, packaging and iden- Inspection certificate or certificate tification, or means a statement, either written or (3) Any appeal inspection of any pre- printed, issued by inspection program viously inspected product. personnel pursuant to the Act and this Shell eggs mean the shell eggs of the part, relative to the class, quality, domesticated chicken, turkey, duck, quantity, and condition of products. goose, and guinea. Inspection program personnel (employee) means employees of the Depart- § 592.5 Designation of official certifi- ment authorized by the Secretary to cates, memoranda, marks, other investigate and certify, in accordance identifications, and devices for pur- with the Act and this part, to shippers poses of the Agricultural Marketing of products and other interested par- Act. ties the class, quality, quantity, and Subsection 203(h) of the Agricultural condition of such products. Marketing Act of 1946, as amended by

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Public Law 272, 84th Congress, provides ADMINISTRATION criminal penalties for various specified offenses relating to official certifi- § 592.10 Authority. cates, memoranda, marks or other The Administrator shall perform, for identifications, and devices for making and under the supervision of the Sec- such marks or identifications, issued or retary, such duties as the Secretary authorized under section 203 of said may require in the enforcement or ad- Act, and certain misrepresentations ministration of the provisions of the concerning the inspection of agricul- Act and this part. The Administrator is tural products under said section. For authorized to waive for a limited pe- the purposes of said subsection and the riod any particular provisions of the provisions in this part, the terms listed regulations in this part to permit ex- below shall have the respective mean- perimentation so that new procedures, ings specified: equipment, and processing techniques (a) Official certificate means any form may be tested to facilitate definite im- of certification, either written or print- provements and at the same time to ed, used under this part to certify with determine full compliance with the respect to the sampling, inspection, spirit and intent of the regulations in class, quality, quantity, or condition of this part. The Food Safety Inspection Service and its officers and employees products (including the compliance of shall not be liable in damages through products with applicable specifica- acts of commission or omission in the tions). administration of this part. (b) Official memorandum means any initial record of findings made by an GENERAL authorized person in the process of inspecting, or sampling pursuant to this § 592.20 Kinds of services available. part, any processing or plant-operation The regulations in this part provide report made by an authorized person in for the following kinds of services: connection with inspecting, or sam- (a) Inspection of the processing in of- pling under this part and any report ficial plants of products containing made by an authorized person of serv- eggs; ices performed pursuant to this part. (b) Sampling of products; and (c) Official mark means the inspection (c) Quantity and condition inspection mark, and any other mark or symbol of products. formulated pursuant to the regulations in this part, stating that the product § 592.22 Where service is offered. was inspected, or for the purpose of Any product may be inspected wher- maintaining the identity of the prod- ever inspection program personnel are uct. available and the facilities and the (d) Official identification means any conditions are satisfactory for the con- United States (U.S.) standard designa- duct of the service. tion of class, quality, quantity, or condition specified in this part or any § 592.24 Basis of service. symbol, stamp, label, or seal indicating (a) Products shall be inspected in ac- that the product has been officially in- cordance with such standards, meth- spected or indicating the class, quality, ods, and instructions as may be issued quantity, or condition of the product or approved by the Administrator. All approved by the Administrator and au- service shall be subject to supervision thorized to be affixed to any product, at all times by the applicable FSIS des- or affixed to or printed on the pack- ignated supervisor. Whenever the su- aging material of any product. pervisor of an inspection program per- (e) Official device means a printed son has evidence that such inspection label, or other method as approved by program employee incorrectly in- the Secretary for the purpose of apply- spected a product, such supervisor ing any official mark or other identi- shall take such action as is necessary fication to any product of the pack- to correct the inspection and to cause aging material thereof. any improper official identification

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that appears on the product or con- sonal supervision, any official identi- tainers thereof to be corrected prior to fication from any package containing shipment of the product from the place products whenever the program em- of the initial inspection. ployee determines that such products (b) Whenever service is performed on were not processed in accordance with a sample basis, such sample shall be the regulations in this part or are not drawn in accordance with the instruc- fit for human food; tions as issued by the Administrator. (5) To issue a certificate upon request on any product processed in the official PERFORMANCE OF SERVICES plant; and § 592.70 Identification. (6) To use retention tags or other de- All inspection program personnel and vices and methods as may be approved supervisors shall have in their posses- by the Administrator for the identi- sion at all times while on duty and fication and control of products that present upon request the means of are not in compliance with the regula- identification furnished by the Depart- tions in this part or are held for fur- ment to such person. ther examination, and any equipment, utensils, rooms or compartments that § 592.80 Political activity. are found to be unclean or otherwise in All inspection program personnel are violation of any of the regulations in forbidden during the period of their re- this part. No product, equipment, uten- spective appointments, to take an ac- sil, room, or compartment shall be re- tive part in political management or in leased for use until it has been made political campaigns. Political activity acceptable. Such identification shall in city, county, State, or national elec- not be removed by anyone other than tions, whether primary or regular, or inspection program personnel. in behalf of any party or candidate is (b) Inspection program personnel prohibited, except as authorized by law shall prepare such reports and records or regulation of the Department. This as may be prescribed by the Adminis- applies to all appointees, including, but trator. not being limited to, temporary and cooperative employees and employees on § 592.95 Facilities and equipment to be leave of absence with or without pay. furnished for use of inspection pro- Willful violation of this section will gram personnel in performing serv- constitute grounds for dismissal. ice. § 592.90 Authority and duties of in- (a) Facilities and equipment for prop- spection program personnel per- er sampling, weighing, examination of forming service. products, and monitoring processing (a) Inspection program personnel are procedures shall be furnished by the of- authorized: ficial plant for use by inspection pro- (1) To make such observations and gram personnel. Such facilities and inspections as they deem necessary to equipment shall include but not be lim- enable them to certify that products ited to a room or area suitable for sam- have been prepared, processed, stored, pling product and stationary or ade- and otherwise handled in conformity quately secured storage box or cage with the regulations in this part; (capable of being locked only by in- (2) To supervise the marking of pack- spection program personnel) for hold- ages containing products that are eligi- ing official samples. ble to be identified with official identi- (b) Acceptable furnished office space fication; and equipment, including but not being (3) To retain in their custody, or limited to, a desk, lockers or cabinets under their supervision, labels with of- (equipped with a satisfactory locking ficial identification, marking devices, device) suitable for the protection and samples, certificates, seals, and reports storage of supplies, and with facilities of inspection program personnel; for inspection program personnel to (4) To deface or remove, or cause to change clothing. be defaced or removed under their per-

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§ 592.96 Schedule of operation of offi- § 592.130 How application for service cial plants. may be made. Inspection operating schedules for (a) On a fee basis. An application for services performed pursuant to this service may be made with any inspec- part shall be requested in writing and tion program personnel at or nearest approved by the appropriate District the place where the service is desired. Office. Normal operating schedules for Such application for service may be made orally (in person or by tele- a full-week consist of a continuous 8- phone), in writing or by transmission. hour period per day (excluding but not If an application for inspection service to exceed 1 hour for lunch), 5 consecu- is made orally, the inspection program tive days per week, within the adminis- personnel with whom such application trative workweek, Sunday through is made, or the Administrator, may re- Saturday, for each shift required. Less quire that the application be confirmed than 8-hour schedules may be rein writing. quested and will be approved if inspec- (b) Form of application. Each appli- tion program personnel are available. cation for inspection of a specified lot Clock hours of daily operations need of any product shall include such infor- not be specified in the request, al- mation as may be required by the Ad- though as a condition of continued ap- ministrator in regard to the product proval, the hours of operation shall and the premises where such product is consist of a continuous 10-hour period to be inspected. per day (excluding but not to exceed 1 hour for lunch), 4 consecutive days per § 592.140 Application for inspection in official plants; approval. week, within the administrative workweek, Sunday through Saturday for Any person desiring to process prod- each full shift required. Inspection pro- ucts under inspection service must re- gram personnel are to be given reason- ceive approval of such plant and facilities as an official plant prior to the in- able advance notice by management of stallation of such service. The initial any change in the hours the inspection survey, drawings, and specifications to service is requested. be submitted, changes and revisions in the official plant, and final survey and APPLICATION FOR SERVICE procedure for plant approval shall be in § 592.100 Who may obtain service. accordance with and conform to the applicable provisions of Part 590 of this (a) An application for service may be chapter. made by any interested person, including, but not being limited to, the § 592.150 When an application may be United States, any State, county, mu- rejected. nicipality, or common carrier, and any (a) Any application for service may authorized agent of the foregoing. be rejected by the Administrator: (b) Where service is offered: Any (1) Whenever the applicant fails to product may be inspected, wherever an meet the requirements of the regula- inspection program employee is avail- tions in this part prescribing the condi- able and the facilities and the conditions under which the service is made tions are satisfactory for the conduct available; of the service. (2) Whenever the product is owned by (c) The applicant must have a tax or located on the premises of a person currently denied the benefits of the identification number for billing pur- Act; poses. (3) Where any individual holding office or a responsible position with or § 592.120 Authority of applicant. having a substantial financial interest Proof of the authority of any person or share in the applicant is currently applying for any service may be re- denied the benefits of the Act or was quired at the discretion of the Admin- responsible in whole or in part for the istrator. current denial of the benefits of the Act to any person;

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(4) Where the Administrator deter- § 592.180 Suspension of plant approval. mines that the application is an at- (a) Any plant approval pursuant to tempt on the part of a person currently the regulations in this part may be sus- denied the benefits of the Act to obtain pended for: service; (1) Failure to maintain plant and (5) Whenever the applicant, after an equipment in a satisfactory state of re- initial survey has been made in accord- pairs; ance with Part 590, fails to bring the (2) The use of operating procedures plant, facilities, and operating proce- that are not in accordance with the dures into compliance with the regula- regulations in this part; or tions in this part within a reasonable (3) Alterations of buildings, facilities, period of time; or equipment that cannot be approved (6) Notwithstanding any prior ap- in accordance with the regulations in proval whenever, before inauguration this part. of service, the applicant fails to fulfill (b) During such period of suspension, commitments concerning the inau- inspection service shall not be ren- guration of the service; dered. However, the other provisions of (7) When it appears that to perform the regulations in this part pertaining the services specified in this part would to providing service will remain in ef- not be to the best interests of the pub- fect unless service is terminated in ac- lic welfare or of the Government; or cordance with the terms thereof. If the (8) When it appears to the Adminis- plant facilities or methods of operation trator that prior commitments of the are not brought into compliance within Department necessitate rejection of a reasonable period of time to be speci- the application. fied by the Administrator, the applica- (b) Each such applicant shall be tion and service shall be terminated. promptly notified by registered mail of Upon termination of service in an offi- the reasons for the rejection. A written cial plant pursuant to the regulations petition for reconsideration of such rein this part, the plant approval shall jection may be filed by the applicant also become terminated, and all labels, with the Administrator if postmarked seals, tags, or packaging material bear- or delivered within 10 days after re- ing official identification shall, under ceipt of notice of the rejection. Such the supervision of a person designated petition shall state specifically the er- by the Administrator, either be de- rors alleged to have been made by the stroyed, or if to be used at another lo- Administrator in rejecting the applica- cation, modified in a manner accept- tion. Within 20 days following the re- able to the Agency. ceipt of such a petition for reconsider- DENIAL OF SERVICE ation, the Administrator shall approve the application or notify the applicant § 592.200 Debarment. by registered mail of the reasons for (a) The following acts or practices or the rejection thereof. the causing thereof may be deemed suf- § 592.160 When an application may be ficient cause for the debarment by the withdrawn. Administrator of any person, including any agents, officers, subsidiaries, or af- An application for service may be filiates of such person, from any or all withdrawn by the applicant at any benefits of the Act for a specified pe- time before the service is performed riod. upon payment, by the applicant, of all (1) Misrepresentation, or deceptive or expenses incurred by the Agency in fraudulent act or practice. Any willful connection with such application. misrepresentation or any deceptive or fraudulent act or practice found to be § 592.170 Order of service. made or committed by any person in Service shall be performed, insofar as connection with: practicable, in the order in which ap- (i) The making or filing of an appli- plications therefor are made except cation for any service or appeal; that precedence may be given to any (ii) The making of the product acces- application for an appeal. sible for sampling or inspection;

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(iii) The making, issuing, or using, or by the Administrator, all violations attempting to issue or use, any certifi- and noncompliance under the Act and cate, symbol, stamp, label, seal, or this part of which such inspection pro- identification authorized pursuant to gram employee has knowledge. the regulations in this part; (iv) The use of the terms ‘‘United § 592.260 Reuse of containers bearing States,’’ ‘‘U.S.,’’ ‘‘U.S. Inspected,’’ official identification prohibited. ‘‘Government Inspected,’’ or terms of The reuse, by any person, of con- similar import in the labeling or adver- tainers bearing official identification is tising of any product; prohibited unless such identification is (v) The use of any official stamp, applicable in all respects to product symbol, label, seal, or identification in being packed therein. In such in- the labeling or advertising of any prod- stances, the container and label may be uct. used provided the packaging is accom- (2) Use of facsimile forms. Using or at- plished under the supervision of inspec- tempting to use a form that simulates tion program personnel or program em- in whole or in part any certificate, ployee, and the container is in clean, symbol, stamp, label, seal, or identi- sound condition and lined with a suit- fication authorized to be issued or used able inner liner. under the regulations in this part. (3) Willful violation of the regula- IDENTIFYING AND MARKING PRODUCTS tions. Any willful violation of the regulations in this part or of the Act. § 592.300 Approval of official identi- (4) Interfering with inspection pro- fication. gram personnel or program employee Labeling procedures, required infor- of the Agency. Any interference with mation on labels, and method of label or obstruction or any attempted inter- approval, shall be in accordance with ference or obstruction of or assault and conform to the applicable provi- upon any inspection program personnel sions of part 590 of this chapter. or program employee of the Agency in the performance of their duties. The § 592.310 Form of official identification giving or offering, directly or indi- symbol and inspection mark. rectly, of any money, loan, gift, or any- (a) The shield set forth in Figure 1, thing of value to a program employee containing the letters ‘‘USDA,’’ shall of the Agency, or the making or offer- be the official identification symbol for ing of any contribution to or in any the purposes of this part and when way supplementing the salary, com- used, imitated, or simulated in any pensation or expenses of a program em- manner in connection with a product ployee of the Agency, or the offering or shall be deemed to constitute a rep- entering into a private contract or resentation that the product has been agreement with a program employee of officially inspected for the purpose of the Agency for any services to be ren- § 592.5. dered while employed by the Agency. (5) Miscellaneous. The existence of any of the conditions set forth in § 592.150 constituting the basis for the rejection of an application for inspection service.

§ 592.220 Other applicable regulations. Compliance with the regulations in this part shall not excuse failure to comply with any other Federal or any State or municipal applicable laws or regulations.

§ 592.240 Report of violations. Each inspection program employee shall report, in the manner prescribed

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(b) The inspection marks that are (b) The use of simulations or imita- permitted to be used on products shall tions of any official identification by be contained within the outline of a any person is prohibited; shield and with the wording and design (c) Upon termination of inspection set forth in Figure 2 of this section, ex- service in an official plant pursuant to cept the plant number may be followed the regulations in this part, all labels by the letter ‘‘G’’ in lieu of the word or packaging material bearing official ‘‘plant.’’ Alternatively, it may be omit- identification to be used to identify ted from the official shield if applied product packed by the plant shall ei- on the container’s principal display ther be destroyed, or have the official panel or other prominent location and identification completely obliterated preceded by the word ‘‘Plant’’ or fol- under the supervision of a USDA rep- lowed by the letter ‘‘G.’’ resentative, or, if to be used at another location, modified in a manner acceptable to the Agency.

§ 592.340 Supervision of marking and packaging. (a) Evidence of label approval. In- spection program personnel shall authorize the use of official identification on any inspected product when they have evidence that such official identification or packaging material bearing such official identification has been approved in accordance with the provisions of § 592.300. (b) Affixing of official identification. No official identification may be affixed to or placed on or caused to be affixed to or placed on any product or § 592.320 Products that may bear the container thereof except by an inspec- inspection mark. tion program employee or under the Products that are permitted to bear supervision of an inspection program the inspection mark shall be processed employee or other person authorized by in an official plant from edible shell the Administrator. All such products eggs or other edible egg products eligi- shall have been inspected in accord- ble to bear the inspection mark and ance with the regulations in this part. may contain other edible ingredients. Inspection program personnel shall The official mark, when used, shall be have supervision over the use and han- printed or lithographed and applied as dling of all material bearing any offi- a part of the principal display panel of cial identification. the container, but shall not be applied (c) Labels for products sold under to a detachable cover. Government contract. Inspectors-in- charge may approve labels for con- § 592.330 Unauthorized use or disposi- tainers of product sold under a con- tion of approved labels. tract specification to governmental (a) Containers or labels that bear of- agencies when such product is not official identification approved for use fered for resale to the general public: pursuant to § 592.300 shall be used only Provided, that the contract specifica- for the purpose for which approved. tions include complete specific require- Any unauthorized use or disposition of ments with respect to labeling, and are approved containers or labels that bear made available to inspection program any official identification may result personnel. in cancellation of the approval and denial of the use of containers or labels § 592.350 Accessibility of product. bearing official identification or denial Each product for which service is re- of the benefits of the Act pursuant to quested shall be so placed as to disclose the provisions of § 592.200; fully its class, quality, quantity, and

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condition as the circumstances may fied with the determination of the warrant. class, quality, quantity, or condition of product that was inspected by inspec- § 592.360 Certificates. tion program personnel in an official Certificates (including appeal certifi- plant and has not left such plant, and cates) shall be issued on forms ap- the operator of any official plant who proved by the Administrator. is not satisfied with a decision by inspection program personnel on any § 592.370 Certificate issuance. other matter relating to inspection in When performing inspection service such plant, may request an appeal in- at locations other than an official es- spection or review of the decision by tablishment, inspection program per- the inspection program employee by sonnel shall issue a certificate covering filing such request with the inspection each product inspected. An applicant program employee’s immediate super- may request issuance of a certificate visor. for each production lot inspected. (b) All other appeal requests. Any interested party who is not satisfied with § 592.380 Disposition of certificates. the determination of the class, quality, The original and a copy of each cer- quantity, or condition of product that tificate issued pursuant to § 592.370, and has left the official plant where it was not to exceed two additional copies inspected or inspected other than in an thereof if requested by the applicant official plant may request an appeal in- prior to issuance, shall, immediately spection by filing such request with the upon issuance, be delivered or mailed District Manager in the district where to the applicant or designee. Other cop- the product is located. ies shall be filed and retained in accordance with the disposition schedule § 592.420 How to file an appeal. for inspection program records. The request for an appeal inspection or review of an inspection program em- § 592.390 Advance information. ployee’s decision may be made orally Upon request of an applicant, all or or in writing. If made orally, written part of the contents of any certificate confirmation may be required. The ap- issued to such applicant may be tele- plicant shall clearly state the identity phoned or transmitted to the applicant of the product, the decision which is or designee, at the applicant’s expense. questioned, and the reasons for requesting the appeal service. If such ap- APPEALS peal request is based on the results stated on an official certificate, the § 592.400 Who may request an appeal original and all copies of the certifi- inspection or review of an inspec- cate available at the appeal inspection tion program employee’s decision. site shall be provided to the appeal in- An appeal inspection may be re- spection program employee assigned to quested by any interested party who is make the appeal inspection. dissatisfied with the determination by an inspection program employee of the § 592.430 When an application for an class, quality, quantity, or condition of appeal inspection may be refused. any product, as evidenced by the USDA When it appears to the official with inspection mark and accompanying whom an appeal request is filed that label, or as stated on a certificate and the reasons given in the request are a review may be requested by the oper- frivolous or not substantial, class, ator of an official plant with respect to quality, quantity, or that the condition an inspection program personnel deci- of the product has undergone a mate- sion or on any other matter related to rial change since the original inspec- inspection in the official plant. tion, or that the original lot has changed in some manner, or the Act or § 592.410 Where to file an appeal. the regulations in this part have not (a) Appeal of inspection program per- been complied with, the applicant’s re- sonnel decision in an official plant. quest for the appeal inspection may be Any interested party who is not satis- refused. In such case, the applicant

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shall be promptly notified of the rea- for the product involved and shall son(s) for refusal. clearly identify the number and date of the superseded certificate. The § 592.440 Who shall perform the ap- issuance of the appeal certificate may peal. be withheld until any previously issued (a) An appeal inspection or review of certificate and all copies have been re- a decision requested under § 592.410(a) turned when such action is deemed nec- shall be made by the inspection pro- essary to protect the interest of the gram employee’s immediate supervisor Government. When the appeal inspec- or by an inspection program employee tion program employee assigns a dif- assigned by the immediate supervisor ferent class to the lot or determines other than the inspection program em- that a net weight shortage exists, the ployee whose inspection or decision is lot shall be retained pending correction being appealed. of the labeling or approval of the prod- (b) Appeal inspections requested uct disposition by the District Office. under § 592.410(b) shall be performed by an inspection program employee other FEES AND CHARGES than the inspection program employee who originally inspected the product. § 592.500 Payment of fees and charges. (c) Whenever practical, an appeal in- (a) Fees and charges for voluntary spection shall be conducted jointly by base time rate, overtime inspection two inspection program employees. service, and holiday inspection service The assignment of the inspection pro- shall be paid by the interested party gram personnel who will make the ap- making the application for such serv- peal inspection under § 592.410(b) shall ice, in accordance with the applicable be made by the District Manager. provisions of this section and § 592.510 through § 592.530, both inclusive. If so § 592.450 Procedures for selecting ap- required by the Inspection program peal samples. personnel, such fees and charges shall (a) Prohibition on movement of product. be paid in advance. Products shall not have been moved (b) Fees and charges for any service from the place where the inspection shall, unless otherwise required pursu- being appealed was performed and must ant to paragraph (c) of this section, be have been maintained under adequate paid by check, draft, or money order refrigeration, when applicable. payable to the Food Safety Inspection (b) Laboratory analyses. The appeal Service and remitted promptly to sample shall consist of product taken FSIS. from the original sample containers (c) Fees and charges for any service plus an equal number of containers se- under a cooperative agreement with lected at random. When the original any State or person shall be paid in ac- sample containers cannot be located, cordance with the terms of such coop- the appeal sample shall consist of prod- erative agreement. uct taken at random from double the number of original sample containers. § 592.510 Basetime rate. (c) Condition inspection. The appeal (a) For each calendar year, FSIS will sample shall consist of product taken calculate the basetime rate for inspec- from the original sample containers tion services, per hour per program em- plus an equal number of containers se- ployee, using the following formula: lected at random. A condition appeal The quotient of dividing the Office of cannot be made unless all originally Field Operations plus Office of Inter- sampled containers are available. national Affairs inspection program personnel’s previous fiscal year’s reg- § 592.460 Appeal certificates. ular direct pay by the previous fiscal Immediately after an appeal inspec- year’s regular hours, plus the quotient tion is completed, an appeal certificate multiplied by the calendar year’s per- shall be issued to show that the origi- centage of cost of living increase, plus nal inspection was sustained or was not the benefits rate, plus the travel and sustained. Such certificate shall super- operating rate, plus the overhead rate, sede any previously issued certificate plus the allowance for bad debt rate.

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(b) FSIS will calculate the benefits, § 592.520 Overtime rate. travel and operating, overhead, and al- When operations in an official plant lowance for bad debt rate components require the services of inspection per- of the basetime rate, using the fol- sonnel beyond their regularly assigned lowing formulas: tour of duty on any day or on a day (1) Benefits rate. The quotient of di- outside the established schedule, such viding the previous fiscal year’s direct services are considered as overtime benefits costs by the previous fiscal work. The official plant must give rea- year’s total hours (regular, overtime, sonable advance notice to the inspector and holiday), plus the quotient multi- of any overtime service necessary. For plied by the calendar year’s percentage each calendar year, FSIS will calculate cost of living increase. Some examples the overtime rate for inspection serv- of direct benefits are health insurance, ice, per hour per program employee, retirement, life insurance, and Thrift using the following formula: The Savings Plan basic and matching con- quotient of dividing the Office of Field tributions. Operations plus Office of International (2) Travel and operating rate. The Affairs inspection program personnel’s quotient of dividing the previous fiscal previous fiscal year’s regular direct year’s total direct travel and operating pay by previous fiscal year’s regular costs by the previous fiscal year’s total hours, plus the quotient multiplied by hours (regular, overtime, and holiday), the calendar year’s percentage of cost plus the quotient multiplied by the cal- of living increase multiplied by 1.5, endar year’s percentage of inflation. plus the benefits rate, plus the travel (3) Overhead rate. The quotient of di- and operating rate, plus the overhead viding the previous fiscal year’s indi- rate, plus the allowance for bad debt rect costs plus the previous fiscal rate. FSIS calculates the benefits rate, year’s information technology (IT) the travel and operating rate, the over- costs in the Public Health Data Com- head rate, and the allowance for bad munication Infrastructure System debt using the formulas set forth in Fund plus the previous fiscal year’s Of- § 592.510(b), and the cost of living in- fice of Management Program cost in creases and percentage of inflation fac- the Reimbursable and Voluntary Funds tors set forth in § 592.510(c). plus the provision for the operating balance less any Greenbook costs (i.e., [71 FR 2143, Jan. 13, 2006, as amended at 76 costs of USDA support services pro- FR 20228, Apr. 12, 2011] rated to the service component for § 592.530 Holiday rate. which fees are charged) that are not related to food inspection, by the pre- When an official plant requires in- vious fiscal year’s total hours (regular, spection service on a holiday or a day overtime, and holiday) worked across designated in lieu of a holiday, such all funds, plus the quotient multiplied service is considered holiday work. The by the calendar year’s percentage of in- official plant must, in advance of such flation. holiday work, request that the inspec- (4) Allowance for bad debt rate. Pre- tor in charge furnish inspection serv- vious fiscal year’s allowance for bad ices during such period and must pay debt (for example, debt owed that is the Agency for such holiday work at not paid in full by plants and establish- the hourly rate. For each calendar ments that declare bankruptcy) di- year, FSIS will calculate the holiday vided by the previous fiscal year’s total rate for inspection service, per hour per hours (regular, overtime, and holiday) program employee, using the following worked. formula: The quotient of dividing the Office of Field Operations plus Office of (c) The calendar year’s cost of living International Affairs inspection pro- increases and percentage of inflation gram personnel’s previous fiscal year’s factors used in the formulas in this sec- regular direct pay by previous fiscal tion are based on the Office of Manage- year’s regular hours, plus the quotient ment and Budget’s Presidential Eco- multiplied by the calendar year’s per- nomic Assumptions. centage of cost of living increase, mul- [76 FR 20228, Apr. 12, 2011] tiplied by 2, plus the benefits rate, plus

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the travel and operating rate, plus the wholesome, unadulterated, and prop- overhead rate, plus the allowance for erly labeled product. Such examina- bad debt rate. FSIS calculates the ben- tions include, but are not being limited efits rate, the travel and operating to: rate, the overhead rate, and the allow- (a) Sanitation checks of plant prem- ance for bad debt using the formulas ises, facilities, equipment, and proc- set forth in § 592.510(b), and the cost of essing operations. living increases and percentage of in- (b) Checks on ingredients and addi- flation factors set forth in § 592.510(c). tives used in products to ensure that [71 FR 2143, Jan. 13, 2006, as amended at 76 they are not adulterated, are fit for use FR 20229, Apr. 12, 2011] as human food, and are stored, handled, and used in a sanitary manner. SANITARY AND PROCESSING (c) Examination of the eggs or egg REQUIREMENTS products used in the products to ensure they are wholesome, not adulterated, § 592.600 General. and comply with the temperature, pas- Except as otherwise approved by the teurization, or other applicable re- Administrator, the sanitary, proc- quirements. essing, and facility requirements, as (d) Inspection during the processing applicable, shall be the same for the and production of the product to deter- product processed under this part as mine compliance with any applicable for egg products processed under part standard or specification for such prod- 590 of this chapter. uct. (e) Examination during processing of § 592.650 Inspection. the product to ensure compliance with Examinations of the ingredients, approved formulas and labeling. processing, and the product shall be (f) Test weighing and organoleptic made to ensure the production of a examinations of finished product.

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