section_id,title_number,title_name,chapter,subchapter,part_number,part_name,subpart,subpart_name,section_number,section_heading,agency,authority,source_citation,amendment_citations,full_text 9:9:2.0.2.1.35.1.40.1,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,A,Subpart A—Definitions,,§ 381.1 Definitions.,FSIS,,,"[37 FR 9706; May 16, 1972, as amended at 39 FR 4568, Feb. 5, 1974; 40 FR 42338, Sept. 12, 1975; 48 FR 6091, Feb. 10, 1983; 49 FR 2236, Jan. 19, 1984; 49 FR 3643, Jan. 30, 1984; 49 FR 47478, Dec. 5, 1984; 51 FR 37709, Oct. 24, 1986; 64 FR 745, Jan. 6, 1999; 64 FR 56416, Oct. 20, 1999; 66 FR 1770, Jan. 9, 2001; 66 FR 22905, May 7, 2001; 67 FR 13258, Mar. 22, 2002; 69 FR 255, Jan. 5, 2004; 79 FR 56233, Sept. 19, 2014]","(a) For the purposes of the regulations in this part, unless otherwise required by the context, the singular form shall also import the plural and the masculine form shall also import the feminine, and vice versa. (b) For the purposes of such regulations, unless otherwise required by the context, the following terms shall be construed, respectively, to mean: Acceptable. “Acceptable” means suitable for the purpose intended and acceptable to the Administrator. Act. “Act” means the Poultry Products Inspection Act (71 Stat. 441, as amended by the Wholesome Poultry Products Act, 82 Stat. 791; 21 U.S.C. 451 et seq. ). Adulterated. “Adulterated” applies to any poultry product under one or more of the following circumstances: (i) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health; (ii)( a ) If it bears or contains (by reason of administration of any substance to the live poultry or otherwise) any added poisonous or added deleterious substance (other than one which is a pesticide chemical in or on a raw agricultural commodity; a food additive; or a color additive) which may, in the judgment of the Administrator, make such article unfit for human food; ( b ) If it is, in whole or part, a raw agricultural commodity and such commodity bears or contains a pesticide chemical which is unsafe within the meaning of section 408 of the Federal Food, Drug, and Cosmetic Act; ( c ) If it bears or contains any food additive which is unsafe within the meaning of section 409 of the Federal Food, Drug, and Cosmetic Act; ( d ) If it bears or contains any color additive which is unsafe within the meaning of section 706 of the Federal Food, Drug, and Cosmetic Act: Provided, That an article which is not otherwise deemed adulterated under paragraphs (b)(4)(ii) ( b ), ( c ), or ( d ) of this section shall nevertheless be deemed adulterated if use of the pesticide chemical, food additive, or color additive in or on such article is prohibited by the regulations in this part in official establishments; (iii) If it consists in whole or in part of any filthy, putrid, or decomposed substance or is for any other reason unsound, unhealthful, unwholesome, or otherwise unfit for human food; (iv) If it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; (v) If it is, in whole or in part, the product of any poultry which has died otherwise than by slaughter; (vi) If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; (vii) If it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 409 of the Federal Food, Drug, and Cosmetic Act; or (viii) If any valuable constituent has been in whole or in part omitted or abstracted therefrom; or if any substance has been substituted, wholly or in part therefor; or if damage or inferiority has been concealed in any manner; or if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is. Animal food. Any article intended for use as food for dogs, cats, or other animals, derived wholly, or in part, from carcasses or parts or products of the carcass of poultry, except that the term animal food as used herein does not include (i) processed dry animal food or (ii) livestock or poultry feeds manufactured from processed poultry byproducts (such as poultry byproduct meal, hydrolyzed poultry feathers, and hydrolyzed poultry byproducts aggregate). Animal food manufacturer. “Animal Food Manufacturer” means any person engaged in the business of manufacturing or processing animal food. Applicant. “Applicant” means any person who requests inspection service, exemption, or other authorization under the regulations. Biological residue. “Biological Residue” means any substance, including metabolites, remaining in poultry at the time of slaughter or in any of its tissues after slaughter, as the result of treatment or exposure of the live poultry to a pesticide, organic compound, metallic or other inorganic compound, hormone, hormone-like substance, growth promoter, antibiotic, anthelmintic, tranquilizer, or other agent that leaves a residue. Capable of use as human food. The term “capable of use as human food” applies to any carcass, or part or product of a carcass of any poultry, unless it is denatured or otherwise identified as required by the regulations, or it is naturally inedible by humans. Carcass. This term means all parts, including viscera, of any slaughtered poultry. Commerce. “Commerce” means commerce between any State, any territory, or the District of Columbia, and any place outside thereof; or within any territory not organized with a legislative body, or the District of Columbia. Consumer package. “Consumer package” means any container in which a poultry product is enclosed for the purpose of display and sale to household consumers. Container. The term “container” includes any box, can, tin, cloth, plastic, or any other receptacle, wrapper, or cover. Edible. This term means that an article is intended for use as human food. Egg Products Inspection Act. “Egg Products Inspection Act” means the Act so entitled, approved December 29, 1970 (84 Stat. 1620, 21 U.S.C. 1031 et seq. ). Federal Food, Drug, and Cosmetic Act. “Federal Food, Drug, and Cosmetic Act” means the Act so entitled, approved June 25, 1938 (52 Stat. 1040), and acts amendatory thereof or supplementary thereto (21 U.S.C. 301 et seq. ). Federal Meat Inspection Act. “Federal Meat Inspection Act” means the Act so entitled, approved March 4, 1907, 34 Stat. 1260, as amended by the Wholesome Meat Act, 81 Stat. 584 (21 U.S.C. 601 et seq. ). Free from protruding pinfeathers. “Free from protruding pinfeathers” means that the carcass is free from protruding pinfeathers which are visible to an inspector during an examination of the carcass at normal operating speeds. However, a carcass may be considered as being free from protruding pinfeathers if it has a generally clean appearance (especially on the breast), and if not more than an occasional protruding pinfeather is in evidence during a more careful examination of the carcass. Giblets. “Giblets” means the liver from which the bile sac has been removed, the heart from which the pericardial sac has been removed, and the gizzard from which the lining and contents have been removed: Provided, That each such organ has been properly trimmed and washed. Immediate container. “Immediate container” includes any consumer package; or any other container in which poultry products, not consumer packaged, are packed. Inedible. This term means any carcass or any part of a carcass that is either naturally inedible by humans or is rendered unfit for human food by reason of adulteration or denaturing. Inspected for wholesomeness. This term means that the poultry product so identified has been inspected and was found at the time of such inspection to be not adulterated. Inspection. “Inspection” means any inspection required by the regulations to determine whether any poultry or poultry products comply with the requirements of the Act and the regulations. Label. This term applies to any display of written, printed, or graphic matter upon any article or the immediate container (not including package liners) of any article. Labeling. This term applies to all labels and other written, printed, or graphic matter (i) upon any article or any of its containers or wrappers, or (ii) accompanying such article. Misbranded. This term applies to any poultry product under one or more of the following circumstances: (i) If its labeling is false or misleading in any particular; (ii) If it is offered for sale under the name of another food; (iii) If it is an imitation of another food, unless its label bears, in type of uniform size and prominence, the word “imitation” and immediately thereafter, the name of the food imitated; (iv) If its container is so made, formed, or filled as to be misleading; (v) If in a package or other container, unless it bears a label showing: ( a ) The name and place of business of the manufacturer, packer, or distributor; and ( b ) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; except as otherwise provided in § 381.121(a) with respect to the quantity of contents; (vi) If any word, statement, or other information required by or under authority of the Act to appear on the label or other labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use; (vii) If it purports to be or is represented as a food for which a definition and standard of identity or composition is prescribed by the regulations in subpart P of this part unless: ( a ) It conforms to such definition and standard, and ( b ) Its label bears the name of the food specified in the definition and standard, and insofar as may be required by such regulations, the common names of optional ingredients (other than spices, flavoring, and coloring) present in such food. (viii) If it purports to be or is represented as a food for which a standard or standards of fill of container have been prescribed by regulations of the Secretary, 2 and falls below the standard of fill of container applicable thereto, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard; 2 No such standards are currently in effect. However, § 381.129 prohibits the use of false or misleading containers. (ix) If it is not subject to the provisions of paragraph (b)(vii) of this section, unless its label bears: ( a ) The common or usual name of the food, if any there be, and ( b ) In case it is fabricated from two or more ingredients, the common or usual name of each ingredient, except as otherwise provided in § 381.118(c); (x) If it purports to be or is represented for special dietary uses, unless the label bears such information concerning its vitamin, mineral, and other dietary properties as is required by § 381.124; (xi) If it bears or contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears a label stating that fact; except as otherwise provided in § 381.119, or (xii) If it fails to bear, directly thereon or on its containers, when required by § 381.123, the official inspection legend and the official establishment number of the establishment where the product was processed; and unrestricted by any of the foregoing; such other information as the Administrator may require in the regulations to assure that it will not have false or misleading labeling and that the public will be informed of the manner of handling required to maintain the article in a wholesome condition. Nonfood compounds. Any substance proposed for use in official establishments, the intended use of which will not result, directly or indirectly, in the substance becoming a component or otherwise affecting the characteristics of poultry or poultry products, excluding labeling and packaging materials as covered in subpart N of this part. Official certificate. This term means any certificate prescribed in subpart M of this part relating to poultry or poultry products. Official device. This term means any label or other device prescribed in subpart M of this part for use in applying any official mark. Official establishment. “Official establishment” means any establishment as determined by the Administrator at which inspection of the slaughter of poultry, or the processing of poultry products, is maintained pursuant to the regulations. Official import inspection establishment. This term means any establishment, other than an official establishment as defined in this definition where inspections are authorized to be conducted as prescribed in § 381.199. Official inspection legend. This term means the official inspection mark prescribed in § 381.96 or the official poultry identification mark prescribed in § 381.97, showing that an article was inspected for wholesomeness and passed in accordance with the Act. Official mark. This term means any symbol prescribed in subpart M of this part to identify the status of any article or poultry under the Act. Packaging material. Any cloth, paper, plastic, metal, or other material used to form a container, wrapper, label, or cover for poultry products. Pesticide chemical, food additive, color additive, raw agricultural commodity. These terms shall have the same meanings for the purposes of the Act and the regulations as under the Federal Food, Drug, and Cosmetic Act. Poultry. “Poultry” means any domesticated bird (chickens, turkeys, ducks, geese, guineas, ratites, or squabs, also termed young pigeons from one to about thirty days of age), whether live or dead. Poultry product. (i) This term means any poultry carcass or part thereof; or any product which is made wholly or in part from any poultry carcass or part thereof, excepting those exempted from definition as a poultry product in § 381.15. Except where the context requires otherwise (e.g., in paragraph (b)(42) of this section), this term is limited to articles capable of use as human food. (ii) Poultry food product. This term means any product capable of use as human food which is made in part from any poultry carcass or part thereof, excepting those exempted from definition as a poultry product in § 381.15. Poultry products broker. “Poultry products broker” means any person engaged in the business of buying or selling poultry products on commission, or otherwise negotiating purchases or sales of such articles other than for his own account or as an employee of another person. Process. Process used as a verb means to conduct any operation or combination of operations, whereby poultry is slaughtered, eviscerated, canned, salted, stuffed, rendered, boned, cut up, or otherwise manufactured or processed. The term “process” does not refer to freezing of poultry products, except when freezing is incidental to operations otherwise classed as “processing” under this paragraph. Process authority. A person or organization with expert knowledge in poultry production process control and relevant regulations. Process schedule. A written description of processing procedures, consisting of any number of specific, distinct, and ordered operations directly under control of the establishment employed in the manufacture of a specific product, including the control, monitoring, verification, validation, and corrective action activities associated with production. Ready-to-cook poultry. “Ready-to-cook poultry” means any slaughtered poultry free from protruding pinfeathers and vestigial feathers (hair or down), from which the head, feet, crop, oil gland, trachea, esophagus, entrails, and lungs have been removed, and from which the mature reproductive organs and kidneys may have been removed, and with or without the giblets, and which is suitable for cooking without need of further processing. Ready-to-cook poultry also means any cut-up or disjointed portion of poultry or other parts of poultry, such as reproductive organs, head, or feet that are suitable for cooking without need of further processing. Regulations. “Regulations” means the provisions of this entire part. Renderer. “Renderer” means any person engaged in the business of rendering carcasses, or parts or products of the carcasses, of poultry, except rendering conducted under inspection or exemption pursuant to the regulations. Shipping container. “Shipping container” means any container used or intended for use in packaging the product packed in an immediate container. Slaughter. “Slaughter” means the act of killing poultry for human food. State. Except as otherwise provided in § 381.220 “State” means any State of the United States and the Commonwealth of Puerto Rico. Supervision. This term means the controls, as prescribed in instructions to Inspection Service employees, to be exercised by them over particular operations to insure that such operations are conducted in compliance with the Act and the regulations in this part. Territory. The term “territory” means Guam, the Virgin Islands of the United States, American Samoa, and any other territory or possession of the United States, excluding the Canal Zone. United States. This term means the States, the District of Columbia, and the territories of the United States. U.S. Condemned. This term means that the poultry carcass, or part or product of a poultry carcass, so identified was inspected and found to be adulterated and is condemned. U.S. Detained. This term is applicable to poultry, poultry products, and other articles which are held in official custody in accordance with section 19 of the Act and § 381.210, pending disposal as provided in said section 19. U.S. Refused Entry. This term means that the slaughtered poultry or other poultry product so identified was presented for inspection for entry into the United States and was found not to comply with the requirements of the Act. U.S. Rejected. This term means that the equipment or facility so identified is prohibited from being used in the processing of any poultry or poultry product until such equipment or facility is found by an inspector to be sanitary and otherwise eligible for use under the regulations. U.S. Retained. This term means that the poultry or carcass, or part or product of a carcass, of poultry so identified is held at an official establishment by the inspection service for further determination as to its disposal. (c) For the purposes of the standard for cooked, smoked sausage (§ 319.180 of this chapter), the term “poultry byproduct” means the skin, fat, gizzard, heart, or liver, or any combination thereof, of any poultry." 9:9:2.0.2.1.35.10.40.1,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,J,Subpart J—Ante Mortem Inspection,,§ 381.70 Ante mortem inspection; when required; extent.,FSIS,,,"[37 FR 9706, May 16, 1972, as amended at 66 FR 22906, May 7, 2001]","(a) An ante mortem inspection of poultry shall, where and to the extent considered necessary by the Administrator and under such instructions as he may issue from time to time, be made of poultry on the day of slaughter in any official establishment. (b) The examination and inspection of ratites will be on the day of slaughter, except: (1) When it is necessary for humane reasons to slaughter an injured animal at night or on a Sunday or holiday, and the FSIS veterinary medical officer cannot be obtained; or (2) In low volume establishments, when ante mortem inspection cannot be done on the day of slaughter, and the birds to be slaughtered have received ante mortem inspection in the last 24 hours, provided the establishment has an identification and control system over birds that have received ante mortem inspection." 9:9:2.0.2.1.35.10.40.2,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,J,Subpart J—Ante Mortem Inspection,,§ 381.71 Condemnation on ante mortem inspection.,FSIS,,,"[37 FR 9706, May 16, 1972, as amended at 66 FR 22906, May 7, 2001; 67 FR 13258, Mar. 22, 2002]","(a) Birds plainly showing on ante mortem inspection any disease or condition, that under §§ 381.80 to 381.93, inclusive, would cause condemnation of their carcasses on post mortem inspection, shall be condemned. Birds which on ante mortem inspection are condemned shall not be dressed, nor shall they be conveyed into any department of the official establishment where poultry products are prepared or held. Poultry which has been condemned on ante mortem inspection and has been killed or died otherwise shall under the supervision of an inspector of the Inspection Service, be disposed of as provided in § 381.95. (b) Dead-on-arrival ratites and ratites condemned on ante mortem inspection will be tagged “U.S. Condemned” by an establishment employee under FSIS supervision and disposed of by one of the methods prescribed in § 381.95. (c) All seriously crippled ratites and non-ambulatory ratites, commonly termed “downers,” shall be identified as “U.S. Suspects.” (d) Ratites exhibiting signs of drug or chemical poisoning shall be withheld from slaughter. (e) Ratites identified as “U.S. Suspects” or “U.S. Condemned” may be set aside for treatment. The “U.S. Suspect” or “U.S. Condemned” identification device will be removed by an establishment employee under FSIS supervision following treatment if the bird is found to be free of disease. Such a bird found to have recovered from the condition for which it was treated may be released for slaughter or for purposes other than slaughter, provided that in the latter instance permission is first obtained from the local, State, or Federal sanitary official having jurisdiction over movement of such birds. (f) When it is necessary for humane reasons to slaughter an injured ratite at night or Sunday or a holiday, and the Agency veterinary medical officer cannot be obtained, the carcass and all parts shall be kept for inspection, with the head and all viscera except the gastrointestinal tract held by the natural attachment. If all parts are not so kept for inspection, the carcass shall be condemned. If on inspection of a carcass slaughtered in the absence of an inspector, any lesion or other evidence is found indicating that the bird was sick or diseased, or affected with any other condition requiring condemnation of the animal on ante mortem inspection, or if there is lacking evidence of the condition that rendered emergency slaughter necessary, the carcass shall be condemned. Ratites that are sick, dying, or that have been treated with a drug or chemical and presented for slaughter before the required withdrawal period, are not covered by emergency slaughter provisions." 9:9:2.0.2.1.35.10.40.3,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,J,Subpart J—Ante Mortem Inspection,,§ 381.72 Segregation of suspects on ante mortem inspection.,FSIS,,,"[66 FR 22906, May 7, 2001]","(a) All birds, except ratites, that on ante mortem inspection do not plainly show, but are suspected of being affected with, any disease or condition that under §§ 381.80 to 381.93 of this Part may cause condemnation in whole or in part on post mortem inspection, shall be segregated from the other poultry and held for separate slaughter, evisceration, and post mortem inspection. The inspector shall be notified when such segregated lots are presented for post mortem inspection, and inspection of such birds shall be conducted separately. Such procedure for the correlation of ante mortem and post mortem findings by the inspector, as may be prescribed or approved by the Administrator, shall be carried out. (b) All ratites showing symptoms of disease will be segregated, individually tagged as “U.S. Suspects” by establishment personnel under FSIS supervision with a serially numbered metal or plastic leg band or tag bearing the term “U.S. Suspect,” and held for further examination by an FSIS veterinarian. Depending upon the findings of the veterinarian's examination, these birds will either be passed for regular slaughter, slaughtered as suspects, withheld from slaughter, or condemned on ante mortem. Those ratites affected with conditions that would be readily detected on post mortem inspection need not be individually tagged on ante mortem inspection with the “U.S. Suspect” tag provided that such ratites are segregated and otherwise handled as “U.S. Suspects.” All ratites identified as “U.S. Condemned” shall be tagged by establishment personnel, under FSIS supervision, with a serially numbered metal or plastic leg band or tag bearing the term “U.S. Condemned.”" 9:9:2.0.2.1.35.10.40.4,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,J,Subpart J—Ante Mortem Inspection,,§ 381.73 Quarantine of diseased poultry.,FSIS,,,,"If live poultry, which is affected by any contagious disease which is transmissible to man, is brought into an official establishment, such poultry shall be segregated. The slaughtering of such poultry shall be deferred and the poultry shall be dealt with in one of the following ways: (a) If it is determined by a veterinary inspector that further handling of the poultry will not create a health hazard, the lot shall be slaughtered separately, subject to ante mortem and post mortem inspection pursuant to the regulations. (b) If it is determined by a veterinary inspector that further handling of the poultry will create a health hazard, such poultry may be released for treatment under the control of an appropriate State or Federal agency. If the circumstances are such that release for treatment is impracticable, a careful bird-by-bird ante mortem inspection shall be made, and all birds found to be, or which are suspected of being, affected with a contagious disease transmissible to man shall be condemned." 9:9:2.0.2.1.35.10.40.5,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,J,Subpart J—Ante Mortem Inspection,,§ 381.74 Poultry suspected of having biological residues.,FSIS,,,"[47 FR 41336, Sept. 20, 1982]","When any poultry at an official establishment is suspected of having been treated with or exposed to any substance that may impart a biological residue that would make their edible tissues adulterated, they shall, at the option of the operator of the establishment, be processed at the establishment and the carcasses and all parts thereof retained under U.S. Retained tags, pending final disposition in accordance with § 381.80, of this part, and other provisions in subpart K; or they shall be slaughtered at the establishment and buried or incinerated in a manner satisfactory to the inspector. Alternatively, such poultry may be returned to the grower, if further holding is likely to result in their not being adulterated by reason of any residue. The Inspection Service will notify the other Federal and State agencies concerned of such action. To aid in determining the amount of residue present in the poultry, officials of the Inspection Service may permit the slaughter of any such poultry for the purpose of collecting tissues for analysis of the residue. Such analysis may include the use of inplant screening procedures designed to detect the presence of antimicrobial residues in any species of poultry." 9:9:2.0.2.1.35.10.40.6,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,J,Subpart J—Ante Mortem Inspection,,§ 381.75 Poultry used for research.,FSIS,,,"[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974]","(a) No poultry used in any research investigation involving an experimental biological product, drug, or chemical shall be eligible for slaughter at an official establishment unless the operator of such establishment, the sponsor of the investigation, or the investigator has submitted to the Inspection Service, or the Veterinary Biologics unit of Veterinary Services, Animal and Plant Health Inspection Service of the Department or the Environmental Protection Agency, or the Food and Drug Administration of the Department of Health, Education, and Welfare, data or a summary evaluation of the data which demonstrates that the use of such biological product, drug, or chemical will not result in the products of such poultry being adulterated, and the Administrator has approved such slaughter." 9:9:2.0.2.1.35.11.40.1,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,K,Subpart K—Post Mortem Inspection; Disposition of Carcasses and Parts,,"§ 381.76 Post-mortem inspection under Traditional Inspection, the Streamlined Inspection System (SIS), the New Line Speed (NELS) Inspection System, the New Poultry Inspection System (NPIS), the New Turkey Inspection System (NTI), and Ratite Inspection.",FSIS,,,"[47 FR 23435, May 28, 1982, as amended at 49 FR 42555, Oct. 23, 1984; 50 FR 37513, Sept. 16, 1985; 50 FR 38097, Sept. 20, 1985; 51 FR 3574, Jan. 29, 1986; 53 FR 46861, Nov. 21, 1988; 62 FR 5143, Feb. 4, 1997; 65 FR 34390, May 30, 2000; 66 FR 22906, May 7, 2001; 79 FR 49635, Aug. 21, 2014; 88 FR 55913, Aug. 17, 2023]","(a) A post-mortem inspection shall be made on a bird-by-bird basis on all poultry eviscerated in every official establishment. Each carcass, or all parts comprising such carcass, must be examined by an inspector, except for parts that are not needed for inspection purposes and are not intended for human food and are condemned. Each carcass eviscerated shall be prepared as ready-to-cook poultry. (b)(1) There are six systems of post-mortem inspection: the New Poultry Inspection System (NPIS), which may be used for young chickens and turkeys; the Streamlined Inspection System (SIS) and the New Line Speed Inspection System (NELS), both of which may be used only for broilers and cornish game hens; the New Turkey Inspection (NTI) System, which may be used only for turkeys; Traditional Inspection, which may be used for all poultry, except for ratites; and Ratite Inspection. (i) The SIS shall be used only for broilers and cornish game hens if: ( a ) The Administrator determines that SIS will increase inspector efficiency; or ( b ) The operator requests SIS and the Administrator determines that the system will result in no loss of inspection efficiency. (ii) The NELS Inspection System shall be used only for broilers and cornish game hens if: ( a ) The operator requests the NELS Inspection System, and ( b ) The Administrator determines that the establishment has the intent and capability to operate at line speeds greater than 70 birds per minute, and meets all the facility requirements in § 381.36(d). (iii) The NTI System shall be used only for turkeys if: ( a ) The operator requests it, and ( b ) The Administrator determines that the establishment meets all the facility requirements in § 381.36(e). (iv) The NPIS may be used for young chickens and turkeys if the official establishment requests to use it and meets or agrees to meet the requirements of paragraph (b)(6) of this section and the Administrator approves the establishment's request. The Administrator may permit establishments that slaughter classes of poultry other than young chickens and turkeys to operate under the New Poultry Inspection System under a waiver from the provisions of the regulations as provided in § 381.3(b). (v) Traditional Inspection shall be used for turkeys when neither the NTI System nor the NPIS is used. For other classes of poultry, Traditional Inspection shall be used when SIS, NELS, and the NPIS are not used. (2) Official establishments that operate under Traditional Inspection, SIS, NELS, NTI, or Ratite Inspection must meet the following requirements: (i) No viscera or any part thereof may be removed from any poultry processed in any official establishment, except at the time of post-mortem inspection, unless its identity with the rest of the carcass is maintained in a manner satisfactory to the inspector until such inspection is made. (ii) Each carcass to be eviscerated must be opened so as to expose the organs and the body cavity for proper examination by the inspector. (iii) If a carcass is frozen, it must be thoroughly thawed before being opened for examination by an inspector. (3) The following requirements are applicable to SIS: (i) Definitions. For purposes of this paragraph, the following definitions shall apply: ( a ) Cumulative sum (CUSUM). A statistical concept used by the establishment and monitored by the inspector whereby compliance is determined based on sample results collected over a period of time. For purposes of determining compliance with the finished product standards, the CUSUM is equal to the sum of prior test results plus the weighted result of the current test minus the tolerance, with the condition that the resulting CUSUM cannot go below zero. ( b ) Tolerance number. A weighted measure that equates to product being produced at a national product quality level. See Table 2. ( c ) Action number. A level reached by the CUSUM where the process is out of control and product action is required by the establishment or the inspector. See Table 2. ( d ) “Start number”. A value halfway between zero and the action number. The start number is used to determine the starting CUSUM for the first subgroup of a shift and to reset the CUSUM value if the CUSUM is equal to or greater than the action number. See Table 2. ( e ) Subgroup. A 10-bird sample collected before product enters the chiller and after product leaves the chiller. ( f ) Subgroup absolute limit. The tolerance number plus 5. See Table 2. ( g ) Prechill testing. Testing conducted by the establishment to determine the CUSUM on consecutive 10-bird subgroup samples collected prior to product entering the chilling system. ( h ) Postchill testing. Testing conducted by the establishment to determine the CUSUM on consecutive 10-bird subgroup samples collected as the product leaves the chilling system. ( i ) Rework. Reprocessing the product to correct the condition or conditions causing the nonconformances listed in Table 1. (ii) General. (a ) Under SIS, one inspector inspects the outside, inside, and viscera of each bird. There may be two inspectors on one processing line, each inspecting every other bird. For the establishment to run its processing line(s) at maximum speed, optimal conditions must be maintained so that inspection may be conducted efficiently. The inspector in charge determines the speed at which each processing line may be operated to permit inspection. A variety of conditions may affect this determination including the health of each flock and the manner in which birds are being presented to the inspector for inspection. ( b ) SIS may be performed by one inspector (SIS-1) or two inspectors (SIS-2). SIS-1 requires that the establishment provide one inspection station for each line and adequate reinspection facilities so carcasses can be removed from each line for evaluation. The maximum line speed for SIS-1 is 35 birds per minute. SIS-2 requires that the establishment provide two inspection stations for each line and adequate reinspection facilities so carcasses can be removed from each line for evaluation. The maximum line speed for SIS-2 is 70 birds per minute. ( c ) Under all inspection systems, including SIS, inspectors conduct post-mortem inspection and look for a number of conditions, as specified elsewhere in this subpart, which may indicate adulteration. Adulterated product is condemned and destroyed, except that carcasses and parts which may be made unadulterated by reprocessing (reworking) may be so reprocessed under the supervision of an inspector and reinspected. Under SIS, inspectors also reinspect product by sampling finished birds (both before and after chilling) for nonconformances with finished product standards (see Table 1). If such nonconformances are present at certain statistical levels, it may indicate process difficulties requiring corrective action by the establishment. If the establishment does not take adequate corrective action, the inspector shall initiate corrective actions such as conducting closer post-mortem inspections and requiring reprocessing and reinspection of previously processed carcasses and parts. Thus, SIS is conducted in two phases—a post-mortem inspection phase and a reinspection phase. The following paragraphs describe the inspection requirements (not addressed elsewhere in this subpart) under each. (iii) Post-mortem inspection. ( a ) Facilities: Each inspection station must comply with the facility requirements in § 381.36(c). ( b ) Presentation: Each inspector shall be flanked by an establishment employee assigned to be the inspector's helper. The one inspector on the SIS-1 line shall be presented every bird. Each inspector on the SIS-2 line shall be presented every other bird on the line. An establishment employee shall present each bird to the inspector properly eviscerated with the back side toward the inspector and the viscera uniformly trailing or leading. Each inspector shall inspect the inside, viscera, and outside of all birds presented. ( c ) Disposition: The inspector shall determine which birds shall be salvaged, reprocessed, condemned, retained for disposition by the veterinarian, or allowed to proceed down the line as a passed bird subject to trim and reinspection. Carcasses with certain defects not requiring condemnation of the entire carcass shall be passed by the inspector, but shall be subject to reinspection to ensure the physical removal of the defects. The helper, under the supervision of the inspector, shall mark such carcasses for trim when the defects are not readily observable. Trimming of birds passed subject to reinspection shall be performed by: ( 1 ) The helper, time permitting, and ( 2 ) One or more plant trimmers positioned after all giblets are harvested and prior to reinspection. (iv) Reinspection. ( a ) Facilities: Reinspection stations are required at both the prechill and postchill locations. The Agency will determine the number of stations needed in those establishments having more than one processing line or more than one chiller. One or more prechill reinspection stations shall be conveniently located at the end of the line or lines prior to chilling. One or more postchill stations must be conveniently located at the end of the chiller or chillers. The prechill and postchill reinspection stations must meet the following provisions: ( 1 ) Floor space shall consist of 3 feet along each conveyor line. The space shall be level and protected from all traffic and overhead obstructions. ( 2 ) A table at least 2 feet wide and 2 feet deep and 3 feet in height designed to be readily cleanable and drainable shall be provided for reinspecting the sampled birds. ( 3 ) A minimum of 200 foot-candles of shadow-free lighting with a minimum color rendering index of 85 on the table surface. ( 4 ) A separate clip board holder shall be provided for holding the recording sheets. ( 5 ) Hangback racks designed to hold 10 carcasses shall be provided for and positioned within easy reach of the person at the station. ( b ) Disposition: An inspector shall monitor the establishment's application of the Finished Product Standards program and shall take corrective action including retaining product to prevent adulterated product from leaving the establishment when the inspector determines that the establishment has failed to apply the program as prescribed in paragraph (b)(3)(iv)( c ) of this section). ( c ) Finished Product Standards: Finished Product Standards (FPS) are criteria applied to processed birds before and after chill to ensure that the product being produced is consistently wholesome and unadulterated. These criteria consist of nonconformances (listed in Table 1), the incidence of which is determined from 10 bird subgroup samples, reduced to a CUSUM number, and measured against the standards (Table 2). The standards are applied to permit the Agency to estimate when the production process is in control and when it is out of control. The establishment is responsible for maintaining FPS which, in turn, is monitored by the inspector. FPS is applied in two separate parts. The first is called prechill testing. It is designed to ensure that the slaughter and evisceration procedures are in control. Compliance is measured by determining the CUSUM on consecutive 10-bird subgroup samples collected prior to product entering the chilling system. The second part of the FPS is called postchill testing. It is designed to monitor the production through the chill system to ensure that it meets the postchill FPS. This test is independent of the prechill test. Compliance is measured by determining the CUSUM on consecutive 10-bird subgroup samples as they exit the chilling system. When the system is operating within compliance, the establishment applies the FPS to product samples at the prechill reinspection station. Testing time and time between tests are such that birds represented by the test are still within the chiller. If an out-of-compliance condition is found, the product leaving the chiller is segregated for rework and retested before it may proceed into commerce. A second 10 bird subgroup sample of the birds is taken after they leave the chiller to ensure that the product meets the postchill FPS. Since the product is closer to the end of processing, the controls on releasing reworked product are stricter than controls under prechill testing, again to ensure that no adulterated product enters into commerce. ( d ) Prechill testing. The prechill FPS have been divided into processing and trim categories. The processing category is designed to monitor the output of the dressing and evisceration procedures. The trim category monitors the establishment's ability to remove unwholesome lesions and conditions from inspected and passed carcasses. Each category is monitored independently of the other category using a separate CUSUM for each category. ( 1 ) Actions to be taken when the process is in control. If the CUSUM is less than the action number and the subgroup absolute limit is not exceeded, the process is judged to be in control. ( i ) Establishment Actions. The establishment shall: ( A ) Randomly select and record subgroup sampling times for each production unit of time before product reaches the prechill reinspection station on the production line. In no case shall the time between tests exceed 1 hour of production time. ( B ) Conduct a 10-bird subgroup test at a random time on each poultry slaughter line. These times are preselected by the establishment and available to the inspector prior to the start of the shift/day's operations. All 10 samples of the subgroup shall be collected at the random time. ( C ) Obtain the weighted value of each nonconformance by multiplying the number recorded for each nonconformance by the “factor” in Table 1, sum the total of all the nonconformances, and calculate the CUSUM value for that test. ( ii ) Inspector Actions. The inspector shall: ( A ) Select random times for monitoring subgroup tests for each half-shift on the evisceration line. In establishments that have multiple evisceration lines on a production shift, monitor all lines of product at the random times. ( B ) Collect the subgroup samples to be monitored at preselected times. All 10 samples of the subgroup shall be collected at the random time selected in paragraph (b)(3)(iv)( d )( 1 )( ii )( A ) of this section. ( C ) Conduct the 10-bird monitoring subgroup test. ( 2 ) Actions to be taken when the subgroup absolute limit is exceeded. If either an inspector or establishment subgroup test exceeds the subgroup absolute limit of tolerance plus 5 (T + 5), the establishment shall determine if any of the immediate past 5 plant prechill subgroups for that category (processing or trim) resulted in a CUSUM above the start number. ( i ) If all of the past 5 plant prechill subgroups are at or below the start number, the establishment shall immediately conduct a retest subgroup on that category of prechill to determine sample validity. If retest subgroup total equals tolerance or less, the establishment resumes random time testing. If the retest subgroup total exceeds tolerance, the establishment shall proceed as if CUSUM reaches the action number and shall begin process actions as set forth in paragraph (b)(3)(iv)( d )( 4 ) of this section. In either case, the prechill retest results will be used to calculate CUSUM. ( ii ) If any of the past 5 plant prechill subgroups resulted in a CUSUM above the start number, the establishment shall proceed as if CUSUM reaches the action number and shall begin process actions as set forth in paragraph (b)(3)(iv)( d )( 4 ) of this section. ( 3 ) Actions to be taken when a trimmable lesion/condition is found. If either inspection or plant monitoring finds any trimmable lesion or condition as specified in item B(7) of Table 1 during a prechill subgroup test, the establishment shall immediately conduct an additional prechill subgroup test for the same trimmable lesion/condition category. This is a requirement on the subgroup testing for the prechill trim nonconformance that is in addition to the CUSUM test described in paragraph (b)(3)(iv)( d )( 1 ) of this section. ( i ) If no additional item in the same category is found on retest, the establishment shall resume random time sampling. ( ii ) If an additional item in the same category is found on retest, the establishment shall proceed as if CUSUM reaches the action number and shall initiate corrective action set forth in paragraph (b)(3)(iv)( d )( 4 ) of this section for this category only. ( 4 ) Actions to be taken when the CUSUM reaches the action number. Once CUSUM reaches the action number, the process is judged to be not in control. ( i ) Establishment Actions. The establishment shall: ( A ) Immediately notify the inspector in charge and the production supervisor responsible for the affected evisceration line. ( B ) Suspend random time prechill testing of the affected nonconformance category (processing or trim). Suspend random time postchill subgroup testing when the processing category is the affected nonconformance category. ( C ) Conduct subgroup retests on carcasses leaving the chill system. Apply the prechill criteria in Table 1 (A) or (B), depending upon which category caused the action, and apply prechill Finished Product Standards as listed in Table 2 to determine product compliance. In no case shall the time between retests exceed 30 minutes of production time. Apply prechill standard criteria at the postchill location after notifying the establishment's production supervisor. If any of these subgroup retests on product leaving the chill system result in a subgroup total exceeding tolerance, identify for rework subsequent product at the postchill location. All noncomplying product will be brought into compliance prior to release into commerce. Product from the chiller will continue accumulating for rework until a subsequent subgroup test results in a subgroup total equal to or less than tolerance. ( D ) Conduct additional subgroup tests at the prechill reinspection station to determine the adequacy of production corrective action. If the prechill tests results in a subgroup total exceeding the tolerance, notify the production supervisor. The number of additional tests at the postchill reinspection station using prechill standards is increased as required to include the product in the chiller represented by this additional prechill test. ( E ) After two consecutive additional prechill subgroup tests result in subgroup totals equal to or less than tolerance: —Resume random time prechill subgroup testing as set forth in actions to be taken when the process is in control at paragraph (b)(3)(iv)( d )( 1 ) of this section. —Identify product entering the chill system that will mark the end of the retest action upon arrival at the postchill sampling location. Such identification may include tagging or empty space in chillers, depending upon the establishment's identification method. —Once all product identified as needing retesting has arrived at the postchill sampling location, random time postchill FPS testing resumes. —If two consecutive additional prechill subgroup tests demonstrate process control with subgroup totals equal to or less than tolerance, but they do not cause CUSUM to fall to the start line or below, reset CUSUM at the start number. —Resume random time prechill subgroup testing as set forth in actions to be taken when the process is in control at paragraph (b)(3)(iv)( d )( 1 ) of this section. —Identify product entering the chill system that will mark the end of the retest action upon arrival at the postchill sampling location. Such identification may include tagging or empty space in chillers, depending upon the establishment's identification method. —Once all product identified as needing retesting has arrived at the postchill sampling location, random time postchill FPS testing resumes. —If two consecutive additional prechill subgroup tests demonstrate process control with subgroup totals equal to or less than tolerance, but they do not cause CUSUM to fall to the start line or below, reset CUSUM at the start number. ( ii ) Inspector Actions. The inspector shall monitor product and process actions by making spot-check observations to ensure that all program requirements are met. ( e ) Postchill testing. Postchill subgroups shall be collected after the product leaves the chiller but before the product is divided into separate processes. Each bird sampled shall be observed and its conformance measured against the postchill criteria. The subgroup nonconformance weights shall be totaled and the CUSUM calculated by subtracting the tolerance from the sum of the subgroup total and the starting CUSUM. ( 1 ) Actions to be taken when the process is in control. If the CUSUM is less than the action number and the subgroup absolute limit is not exceeded, the process is judged to be in control. ( i ) Establishment Actions. The establishment shall conduct a 10-bird subgroup test for each chiller system at a randomly selected time of production. In no case shall the time between tests exceed 2 hours of production time. ( ii ) Inspector Actions. The inspector shall: ( A ) Select random times for postchill monitoring. ( B ) Monitor each chill system twice per shift. ( C ) Conduct subgroup tests at preselected random times. ( 2 ) Actions to be taken when the subgroup absolute limit is exceeded. If either an inspector or establishment subgroup test exceeds the subgroup absolute limit of tolerance plus 5(T + 5), the establishment shall determine if any of the last 5 postchill monitoring subgroups resulted in a CUSUM above the start number. ( i ) If all of the past 5 postchill monitoring subgroups resulted in a CUSUM at or below the start number, the establishment shall immediately retest a subgroup to determine sample validity. If this retest subgroup total exceeds tolerance, the establishment shall proceed as if CUSUM reaches the action number and shall begin process actions as set forth in paragraph (b)(3)(iv)( e )( 3 ) of this section. ( ii ) If any of the past 5 postchill monitoring subgroups resulted in a CUSUM above the start number, the establishment shall proceed as if CUSUM reaches the action number and shall begin process actions as set forth in paragraph (b)(3)(iv)( e )( 3 ) of this section. ( 3 ) Actions to be taken when the CUSUM reaches the action number. Once CUSUM reaches the action number, the process is judged to be not in control. ( i ) Establishment Actions. The establishment shall: ( A ) Notify the inspector in charge and the production supervisor responsible for product in the chiller. ( B ) Suspend random time postchill subgroup testing. ( C ) Immediately conduct an additional postchill subgroup test. If the retest subgroup total exceeds tolerance, the establishment shall identify subsequent product for rework. Product will continue accumulating for rework until a subsequent subgroup test results in a subgroup total equal to or less than tolerance. ( D ) After two consecutive additional postchill subgroup tests results in subgroup totals equal to or less than tolerance: —Resume random time postchill subgroup testing as set forth in actions to be taken when the process is in control at paragraph (b)(3)(iv)( e )( 1 ) of this section. —If the two consecutive additional postchill subgroup totals equal to or less than tolerance do not cause CUSUM to fall to the start number or below, reset CUSUM at the start number. —Resume random time postchill subgroup testing as set forth in actions to be taken when the process is in control at paragraph (b)(3)(iv)( e )( 1 ) of this section. —If the two consecutive additional postchill subgroup totals equal to or less than tolerance do not cause CUSUM to fall to the start number or below, reset CUSUM at the start number. ( ii ) Inspector Actions. The inspector shall monitor product and process actions to ensure that program requirements are met. (v) When the prechill or postchill product has been identified as having been produced when the process was not in control, additional online subgroup testing by the establishment is required to determine its conformance to the standard. If any of the additional plant subgroup testing results in a subgroup total exceeding tolerance, offline product corrective actions must take place. The responsibilities of the establishment and the inspector change depending on the CUSUM. All corrective actions such as identifying affected product, segregating product, and maintaining control through rework actions are the establishment's responsibility. Corrective actions by the inspector depends upon the establishment's ability to control rework of affected product. If the establishment fails in its responsibilities, the inspector will identify, segregate, and retain affected product to prevent adulterated product from reaching consumers. ( a ) Offline product. The establishment shall identify the affected product so that it may be segregated and accumulated offline for rework. The inspector shall spot check the establishment's identification, segregation, and control of reworked product to ensure that program requirements are met. ( b ) Reworked product. Reworked product must be tested by the establishment with a randomly selected subgroup test of the accumulated reworked lot. Before product is released, the random subgroup test must result in a subgroup total equal to or less than tolerance. If the subgroup test of a reworked lot results in a subgroup total exceeding tolerance, the lot must be reworked again before another subgroup is selected. The following actions are required. ( 1 ) Establishment Actions. The establishment shall: ( i ) Select the random subgroup from throughout the lot only after the total lot has been reworked. ( ii ) Conduct the subgroup test using the same criteria (prechill or postchill) that resulted in the rework action. ( iii ) Release the lot if the reworked subgroup test resulted in a subgroup total equal to or less than tolerance. ( iv ) Identify and control the lot to be reworked if the reworked subgroup total again exceeds tolerance. ( 2 ) Inspector Actions: The inspector shall spot check the rework procedure to ensure that plant monitoring and production meet the requirements of the program. (vi) After the 10 bird subgroup tests are completed, the prechill and postchill processing nonconformances shall be corrected on all bird samples prior to returning the samples to the product flow. Samples with trim nonconformances shall be returned to the trim station for correction prior to their return to the product flow. Table 1—Definitions of Nonconformances Table 2—Finished Product Standards (4) The following requirements are also applicable to NELS inspection: (i) Inspection under NELS is conducted in two phases, as post-mortem inspection phase and a reinspection phase. ( a ) Post-mortem inspection. The establishment shall provide three inspection stations on each eviscerating line in compliance with the facility requirements § 381.36(d)(1). The three inspectors shall inspect the inside, viscera, and outside of all birds presented. Each inspector shall be flanked by two establishment employees—the presenter and the helper. The presenter shall ensure that the bird is properly eviscerated and presented for inspection and the viscera uniformly trailing or leading. The inspector shall determine which birds shall be salvaged, reprocessed, condemned, retained for disposition by the veterinarian, or allowed to proceed down the line as a passed bird subject to reinspection. Poultry carcasses with certain defects not requiring condemnation of the entire carcass shall be passed by the inspector, but shall be subject to reinspection to ensure the physical removal of the specified defects. The helper, under the supervision of the inspector, shall mark such carcasses for trim when the defects are not readily observable. Trimming or birds passed subject to reinspection shall be performed by: ( 1 ) The helper, time permitting, and ( 2 ) One or more plant trimmers positioned after giblet harvest and prior to reinspection. ( b ) A reinspection station shall be located at the end of each line. This station shall comply with the facility requirements in § 381.36(d)(2). The inspector shall ensure that the establishment has performed the indicated trimming of carcasses passed subject to reinspection by visually monitoring, checking data, or gathering samples at the station or at other critical points on the line. (ii)-(iii) [Reserved] (iv) The maximum inspection rate for NELS shall be 91 birds per minute per eviscerating line. (5) The following requirements are also applicable to the NTI System: (i) Inspection under the NTI System is conducted in two phases, a post-mortem inspection phase and a reinspection phase. The NTI-1 Inspection System requires that the establishment provide one inspection station for each line and adequate reinspection facilitiates so carcasses can be removed from each line for evaluation. The NTI-2 Inspection System requires that the establishment provide two inspection stations for each line and adequate reinspection facilities so carcasses can be removed from each line for evaluation. ( a ) Post-mortem inspection. Each inspection station must comply with the facility requirements in § 381.36(e)(1). Each inspector shall be flanked by and establishment employee assigned to be the inspector's helper. The one inspector on an NTI-1 Inspection System shall be presented every bird. Each inspector on an NTI-2 Inspection System line shall be presented every other bird on the line. An establishment employee shall present each bird to the inspector properly eviscerated with the back side toward the inspector and the viscera uniformly trailing or leading. Each inspector shall inspect the inside, viscera, and outside of all birds presented. The inspector shall determine which bird shall be salvaged, reprocessed, condemned, retained for disposition by a veterinarian, or allowed to proceed down the line as a passed bird subject to reinspection. Turkey carcasses with certain defects not requiring condemnation of the entire carcass shall be passed by the inspector, but shall be subject to reinspection to ensure the physical removal of the specified defects. The helper, under the supervision of the inspector, shall mark such carcasses for trim when the defects of birds passed subject to reinspection shall be performed by: ( 1 ) The helper, time permitting, and ( 2 ) One or more plant trimmers positioned after the giblet harvest and prior to reinspection. ( b ) Reinspection. A reinspection station shall be located at the end of the lines. This station shall comply with the facility requirements in § 381.36(e)(2). The inspector shall ensure that establishments have performed the indicated trimming of each carcass passed subject to reinspection by visually monitoring, checking data, and/or sampling product at the reinspection station and, if necessary, at other points, critical to the wholesomeness of product, on the eviscerating line. (ii)-(iii) [Reserved] (6) The following requirements are applicable to the NPIS: (i) Facilities. The establishment must comply with the facilities requirements in § 381.36(f). (ii) Carcass sorting and disposition. (A) The establishment must conduct carcass with associated viscera sorting activities, dispose of carcasses and parts exhibiting condemnable conditions, and conduct appropriate trimming and reprocessing activities before carcasses are presented to the online carcass inspector. (B) Any carcasses removed from the line for reprocessing activities or salvage must be returned to the line before the online carcass inspection station. The establishment must include in its written HACCP plan, or sanitation SOP, or other prerequisite program a process by which parts, other than parts identified as “major portions” as defined in § 381.170(b)(22), are available for inspection offline after reprocessing or salvage. (C) The establishment must develop, implement, and maintain written procedures to ensure that poultry carcasses contaminated with septicemic and toxemic conditions do not enter the chiller. The establishment must incorporate these procedures into its HACCP plan, or sanitation SOP, or other prerequisite program. These procedures must cover, at a minimum, establishment sorting activities required under paragraph (b)(6)(ii) of this section. (D) The establishment must maintain records to document that the products resulting from its slaughter operation meet the definition of ready-to-cook poultry in § 381.1. These records are subject to review and evaluation by FSIS personnel. (iii) Presentation for online carcass inspection. To ensure the online carcass inspector may properly inspect every carcass, the establishment must present carcasses as follows: (A) Each carcass, except carcasses and parts identified as “major portions” under 9 CFR 381.179(b)(22), must be held by a single shackle; (B) Both hocks of each carcass must be held by the shackle; (C) The back side of the carcass must be faced toward the inspector; (D) There must be minimal carcass swinging motion; (E) The establishment must ensure that it can sufficiently identify viscera and parts corresponding with each carcass inspected by the online carcass inspector so that if the carcass inspector condemns a carcass all corresponding viscera and parts are also condemned." 9:9:2.0.2.1.35.11.40.10,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,K,Subpart K—Post Mortem Inspection; Disposition of Carcasses and Parts,,§ 381.85 Special diseases.,FSIS,,,,"Carcasses of poultry showing evidence of any disease which is characterized by the presence, in the meat or other edible parts of the carcass, or organisms or toxins dangerous to the consumer, shall be condemned." 9:9:2.0.2.1.35.11.40.11,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,K,Subpart K—Post Mortem Inspection; Disposition of Carcasses and Parts,,§ 381.86 Inflammatory processes.,FSIS,,,,"Any organ or other part of a carcass which is affected by an inflammatory process shall be condemned and, if there is evidence of general systemic disturbance, the whole carcass shall be condemned." 9:9:2.0.2.1.35.11.40.12,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,K,Subpart K—Post Mortem Inspection; Disposition of Carcasses and Parts,,§ 381.87 Tumors.,FSIS,,,"[88 FR 55913, Aug. 17, 2023]","(a) Tumors, including those possibly caused by avian leukosis complex, may be trimmed from any affected organ or other part of a carcass where there is no evidence of metastasis or that the general condition of the bird has been affected by the size, position, or nature of the tumor. Trimmed carcasses otherwise found to be not adulterated shall be passed as human food. (b) Any organ or other part of a carcass which is affected by a tumor where there is evidence of metastasis or that the general condition of the bird has been affected by the size, position, or nature of the tumor, must be condemned." 9:9:2.0.2.1.35.11.40.13,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,K,Subpart K—Post Mortem Inspection; Disposition of Carcasses and Parts,,§ 381.88 Parasites.,FSIS,,,,"Organs or other parts of carcasses which are found to be infested with parasites, or which show lesions of such infestation shall be condemned and, if the whole carcass is affected, the whole carcass shall be condemned." 9:9:2.0.2.1.35.11.40.14,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,K,Subpart K—Post Mortem Inspection; Disposition of Carcasses and Parts,,§ 381.89 Bruises.,FSIS,,,,"Any part of a carcass which is badly bruised shall be condemned and, if the whole carcass is affected as a result of the bruise, the whole carcass shall be condemned. Parts of a carcass which show only slight reddening from a bruise may be passed for food." 9:9:2.0.2.1.35.11.40.15,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,K,Subpart K—Post Mortem Inspection; Disposition of Carcasses and Parts,,§ 381.90 Cadavers.,FSIS,,,,Carcasses of poultry showing evidence of having died from causes other than slaughter shall be condemned. 9:9:2.0.2.1.35.11.40.16,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,K,Subpart K—Post Mortem Inspection; Disposition of Carcasses and Parts,,§ 381.91 Contamination.,FSIS,,,"[37 FR 9706, May 16, 1972, as amended at 43 FR 12847, Mar. 28, 1978; 79 FR 49636, Aug. 21, 2014]","(a) Carcasses of poultry contaminated by volatile oils, paints, poisons, gases, scald vat water in the air sac system, or other substances which render the carcasses adulterated shall be condemned. Any organ or other part of a carcass which has been accidentally multilated in the course of processing shall be condemned, and if the whole carcass is affected, the whole carcass shall be condemned. (b) Any carcass of poultry accidentally contaminated during slaughter with digestive tract contents need not be condemned if promptly reprocessed under the supervision of an inspector and thereafter found not to be adulterated. Contaminated surfaces that are cut must be removed only by trimming. Contaminated inner surfaces that are not cut may be cleaned by trimming alone or may be re-processed as provided in subparagraph (b)(1) or (2) of this section. (1) Online reprocessing. Poultry carcasses accidentally contaminated with digestive tract contents may be cleaned by applying an online reprocessing antimicrobial intervention to all carcasses after evisceration and before the carcasses enter the chiller if the parameters for use of the antimicrobial intervention system have been approved by the Administrator. Establishments must incorporate procedures for the use of any online reprocessing antimicrobial intervention system into their HACCP plans, or sanitation SOPs, or other prerequisite programs. (2) Offline reprocessing. Contaminated inner surfaces that are not cut may be cleaned at an approved reprocessing station away from the main processing line by any method that will remove the contamination, such as vacuuming, washing, and trimming, singly or in combination. All visible specks of contamination must be removed, and if the inner surfaces are reprocessed other than solely by trimming, all surfaces of the carcass must be treated with chlorinated water containing 20 ppm to 50 ppm available chlorine or another approved antimicrobial substance in accordance with the parameters approved by the Administrator. Establishments must incorporate procedures for the use of any offline reprocessing into their HACCP plans, or sanitation SOPs, or other prerequisite programs." 9:9:2.0.2.1.35.11.40.17,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,K,Subpart K—Post Mortem Inspection; Disposition of Carcasses and Parts,,§ 381.92 Overscald.,FSIS,,,,"Carcasses of poultry which have been overscalded, resulting in a cooked appearance of the flesh, shall be condemned." 9:9:2.0.2.1.35.11.40.18,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,K,Subpart K—Post Mortem Inspection; Disposition of Carcasses and Parts,,§ 381.93 Decomposition.,FSIS,,,,"Carcasses of poultry deleteriously affected by post mortem changes shall be disposed of as follows: (a) Carcasses which have reached a state of putrefaction or stinking fermentation shall be condemned. (b) Any part of a carcass which is green struck shall be condemned and, if the carcass is so extensively affected that removal of affected parts is impracticable, the whole carcass shall be condemned. (c) Carcasses affected by types of post mortem change which are superficial in nature may be passed for human food after removal and condemnation of the affected parts." 9:9:2.0.2.1.35.11.40.19,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,K,Subpart K—Post Mortem Inspection; Disposition of Carcasses and Parts,,§ 381.94 Contamination with microorganisms; process control verification criteria and testing; pathogen reduction standards for establishments that slaughter ratites.,FSIS,,,"[61 FR 38866, July 25, 1996, as amended at 62 FR 26218, May 13, 1997; 62 FR 61009, Nov. 14, 1997; 64 FR 66553, Nov. 29, 1999; 67 FR 13258, Mar. 22, 2002; 79 FR 49636, Aug. 21, 2014]","(a) Criteria for verifying process control; E. coli testing. (1) Each official establishment that slaughters ratites shall test for Escherichia coli Biotype I ( E. coli ). Establishments that slaughter ratites and livestock, shall test the type of ratites or livestock slaughtered in the greatest number. The establishment shall: (i) Collect samples in accordance with the sampling techniques, methodology, and frequency requirements in paragraph (a)(2) of this section; (ii) Obtain analytic results in accordance with paragraph (a)(3) of this section; and (iii) Maintain records of such analytic results in accordance with paragraph (a)(4) of this section. (2) Sampling requirements. (i) Written procedures. Each establishment that slaughters ratites shall prepare written specimen collection procedures which shall identify employees designated to collect samples, and shall address location(s) of sampling, how sampling randomness is achieved, and handling of the sample to ensure sample integrity. The written procedure shall be made available to FSIS upon request. (ii) Sample collection. The establishment must collect samples from whole ratites at the end of the chilling process. Samples from ratites may be collected by sponging the carcass on the back and thigh or samples can be collected by rinsing the whole carcass in an amount of buffer appropriate for that type of bird. (iii) Sampling frequency. Establishments that slaughter ratites, except very low volume ratite establishments as defined in paragraph (a)(2)(v) of this section, must take samples at a frequency proportional to the establishment's volume of production at the following rate: 1 sample per 3,000 carcasses, but at a minimum one sample each week of operation. (iv) Sampling frequency alternatives. An establishment operating under a validated HACCP plan in accordance with § 417.2(b) of this chapter may substitute an alternative frequency for the frequency of sampling required under paragraph (a)(2)(iii) of this section if, (A) The alternative is an integral part of the establishment's verification procedures for its HACCP plan and, (B) FSIS does not determine, and notify the establishment in writing, that the alternative frequency is inadequate to verify the effectiveness of the establishment's processing controls. (v) Sampling in very low volume ratite establishments. (A) Very low volume ratite establishments annually slaughter no more than 6,000 ratites. Very low volume ratite establishments that slaughter ratites in the largest number must collect at least one sample during each week of operation after June 1 of each year, and continue sampling at a minimum of once each week the establishment operates until June of the following year or until 13 samples have been collected, whichever comes first. (B) Upon the establishment's meeting the requirements of paragraph (a)(2)(v)(A) of this section, weekly sampling and testing is optional, unless changes are made in establishment facilities, equipment, personnel or procedures that may affect the adequacy of existing process control measures, as determined by the establishment or by FSIS. FSIS determinations that changes have been made requiring resumption of weekly testing shall be provided to the establishment in writing. (3) Analysis of samples. Laboratories may use any quantitative method for analysis of E. coli that is approved as an AOAC Official Method of the AOAC International (formerly the Association of Official Analytical Chemists) or approved and published by a scientific body and based on the results of a collaborative trial conducted in accordance with an internationally recognized protocol on collaborative trials and compared against the three tube Most Probable Number (MPN) method and agreeing with the 95 percent upper and lower confidence limit of the appropriate MPN index. (4) Recording of test results. The establishment shall maintain accurate records of all test results, in terms of colony forming units (CFU)/ml of rinse fluid. Results shall be recorded onto a process control chart or table showing at least the most recent 13 test results. Records shall be retained at the establishment for a period of 12 months and shall be made available to FSIS upon request. (5) Establishments shall evaluate E. coli test results using statistical process control techniques. (6) Failure to meet criteria. Test results that do not meet the criteria described in paragraph (a)(5) of this section are an indication that the establishment may not be maintaining process controls sufficient to prevent fecal contamination. FSIS shall take further action as appropriate to ensure that all applicable provisions of the law are being met. (7) Failure to test and record. Inspection will be suspended in accordance with rules of practice that will be adopted for such proceeding, upon a finding by FSIS that one or more provisions of paragraphs (a) (1) through (4) of this section have not been complied with and written notice of same has been provided to the establishment. (b) [Reserved]" 9:9:2.0.2.1.35.11.40.2,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,K,Subpart K—Post Mortem Inspection; Disposition of Carcasses and Parts,,§ 381.77 Carcasses held for further examination.,FSIS,,,,"Each carcass, including all parts thereof, in which there is any lesion of disease, or other condition which might render such carcass or any part thereof adulterated and with respect to which a final decision cannot be made on first examination by the inspector, shall be held for further examination. The identity of each such carcass, including all parts thereof, shall be maintained until a final examination has been completed." 9:9:2.0.2.1.35.11.40.3,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,K,Subpart K—Post Mortem Inspection; Disposition of Carcasses and Parts,,§ 381.78 Condemnation of carcasses and parts: separation of poultry suspected of containing biological residues.,FSIS,,,"[37 FR 9706, May 16, 1972, as amended at 48 FR 22899, May 23, 1983; 48 FR 23807, May 27, 1983]","(a) At the time of any inspection under this subpart each carcass, or any part thereof, which is found to be adulterated shall be condemned, except that any such articles which may be made not adulterated by reprocessing, need not be so condemned if so reprocessed under the supervision of an inspector and thereafter found to be not adulterated. (b) When a lot of poultry suspected of containing biological residues is inspected in an official establishment, all carcasses and any parts of carcasses in such lot which are condemned shall be kept separate from all other condemned carcasses or parts." 9:9:2.0.2.1.35.11.40.4,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,K,Subpart K—Post Mortem Inspection; Disposition of Carcasses and Parts,,§ 381.79 Passing of carcasses and parts.,FSIS,,,,Each carcass and all organs and other parts of carcasses which are found to be not adulterated shall be passed for human food. 9:9:2.0.2.1.35.11.40.5,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,K,Subpart K—Post Mortem Inspection; Disposition of Carcasses and Parts,,§ 381.80 General; biological residues.,FSIS,,,,"(a) The carcasses or parts of carcasses of all poultry inspected at an official establishment and found at the time of post mortem inspection, or at any subsequent inspection, to be affected with any of the diseases or conditions named in other sections in this subpart, shall be disposed of in accordance with the section pertaining to the disease or condition. Owing to the fact that it is impracticable to formulate rules for each specific disease or conditions and to designate at just what stage a disease process results in an adulterated article, the decision as to the disposal of all carcasses, organs or other parts not specifically covered by the regulations, or by instructions of the Administrator issued pursuant thereto, shall be left to the inspector in charge, and if the inspector in charge is in doubt concerning the disposition to be made, specimens from such carcasses shall be forwarded to the Inspection Service laboratory for diagnosis. (b) All carcasses, organs, or other parts of carcasses of poultry shall be condemned if it is determined on the basis of a sound statistical sample that they are adulterated because of the presence of any biological residues." 9:9:2.0.2.1.35.11.40.6,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,K,Subpart K—Post Mortem Inspection; Disposition of Carcasses and Parts,,§ 381.81 Tuberculosis.,FSIS,,,,Carcasses of poultry affected with tuberculosis shall be condemned. 9:9:2.0.2.1.35.11.40.7,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,K,Subpart K—Post Mortem Inspection; Disposition of Carcasses and Parts,,§ 381.82 [Reserved],FSIS,,,, 9:9:2.0.2.1.35.11.40.8,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,K,Subpart K—Post Mortem Inspection; Disposition of Carcasses and Parts,,§ 381.83 Septicemia or toxemia.,FSIS,,,,"Carcasses of poultry showing evidence of any septicemic or toxemic disease, or showing evidence of an abnormal physiologic state, shall be condemned." 9:9:2.0.2.1.35.11.40.9,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,K,Subpart K—Post Mortem Inspection; Disposition of Carcasses and Parts,,§ 381.84 Airsacculitis.,FSIS,,,"[40 FR 14297, Mar. 31, 1975]",Carcasses of poultry with evidence of extensive involvement of the air sacs with airsacculitis or those showing airsacculitis along with systemic changes shall be condemned. Less affected carcasses may be passed for food after complete removal and condemnation of all affected tissues including the exudate. 9:9:2.0.2.1.35.12.40.1,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,L,Subpart L—Handling and Disposal of Condemned or Other Inedible Products at Official Establishments,,§ 381.95 Disposal of condemned poultry products.,FSIS,,,,"All condemned carcasses, or condemned parts of carcasses, or other condemned poultry products, except those condemned for biological residues shall be disposed of by one of the following methods, under the supervision of an inspector of the Inspection Service. (Facilities and materials for carrying out the requirements in this section shall be furnished by the official establishment.) (a) Steam treatment (which shall be accomplished by processing the condemned product in a pressure tank under at least 40 pounds of steam pressure) or thorough cooking in a kettle or vat, for a sufficient time to effectively destroy the product for human food purposes and preclude dissemination of disease through consumption by animals. (Tanks and equipment used for this purpose or for rendering or preparing inedible products shall be in rooms or compartments separate from those used for the preparation of edible products. There shall be no direct connection by means of pipes, or otherwise, between tanks containing inedible products and those containing edible products.) (b) Incineration or complete destruction by burning. (c) Chemical denaturing, which shall be accomplished by the liberal application to all carcasses and parts thereof, of: (1) Crude carbolic acid, (2) Kerosene, fuel oil, or used crankcase oil, or (3) 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. (d) Any other substance 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. (e) Carcasses and parts of carcasses condemned for biological residue shall be disposed of in accordance with paragraph (b) of this section or by burying under the supervision of an inspector." 9:9:2.0.2.1.35.13.40.1,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,M,"Subpart M—Official Marks, Devices, and Certificates; Export Certificates; Certification Procedures",,§ 381.96 Wording and form of the official inspection legend.,FSIS,,,"[66 FR 22906, May 7, 2001]","Except as otherwise provided in this subpart, the official inspection legend required to be used with respect to inspected and passed poultry products shall include wording as follows: “Inspected for wholesomeness by U.S. Department of Agriculture.” This wording shall be contained within a circle. The form and arrangement of such wording shall be exactly as indicated in the example in Figure 1, except that the appropriate official establishment number shall be shown, and if the establishment number appears elsewhere on the labeling material in the manner prescribed in § 381.123(b), it may be omitted from the inspection mark. The administrator 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 official inspection legend, or the approved abbreviation thereof, shall be printed on consumer packages and other immediate containers of inspected and passed poultry products, or on labels to be securely affixed to such containers of such products and may be printed or stenciled thereon, but shall not be applied by rubber stamping. When applied by a stencil, the legend shall not be less than 4 inches in diameter. An official brand must be applied to inspected and passed carcasses and parts of ratites that are shipped unpacked." 9:9:2.0.2.1.35.13.40.10,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,M,"Subpart M—Official Marks, Devices, and Certificates; Export Certificates; Certification Procedures",,§ 381.105 Marking products for export.,FSIS,,,"[81 FR 42234, June 29, 2016]","When authorized by inspection personnel, establishments must mark the outside container of any inspected and passed product for export, the securely enclosed pallet within the consignment, or closed means of conveyance transporting the consignment, with a mark that contains a unique identifier that links the consignment to the export certificate or an official mark as described in § 381.104. Ship stores, small quantities exclusively for the personal use of the consignee and not for sale or distribution, and shipments by and for the U.S. Armed Forces, are exempt from the requirements of this section." 9:9:2.0.2.1.35.13.40.11,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,M,"Subpart M—Official Marks, Devices, and Certificates; Export Certificates; Certification Procedures",,§ 381.106 Export certification.,FSIS,,,"[81 FR 42234, June 29, 2016]","(a) Exporters must apply for export certification of inspected and passed products to any foreign country. Exporters may apply for an export certificate using a paper or electronic application. FSIS will assess exporters that submit an electronic application the charge in § 362.5(e) of this chapter. (b) FSIS will issue only one certificate for each consignment, except in the case of error in the certificate or loss of the certificate originally issued. A request for a replacement certificate, except in the case of a lost certificate, must be accompanied by the original certificate. The new certificate will carry the following statement: “Issued in replacement of ______”, with the numbers of the certificates that have been superseded. (c) FSIS will deliver a copy of the certificate to the person who requested such certificate or his agent. Such persons may duplicate the certificate as required in connection with the exportation of the product. (d) FSIS will retain a copy of the certificate. (e) Exporters may request inspection personnel to issue certificates for export consignments of product of official establishments not under their supervision, provided the consignments are first identified as having been “U.S. inspected and passed,” are found to be neither adulterated nor misbranded, and are marked as required by § 381.105." 9:9:2.0.2.1.35.13.40.12,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,M,"Subpart M—Official Marks, Devices, and Certificates; Export Certificates; Certification Procedures",,§ 381.107 Special procedures as to certification of poultry products for export to certain countries.,FSIS,,,"[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 41 FR 23702, June 11, 1976]","When export certificates are required by any foreign country for poultry products exported to such country, the Administrator shall in specific cases prescribe or approve the form of export certificate to be used and the methods and procedures he deems appropriate with respect to the processing of such products, in order to comply with requirements specified by the foreign country regarding the export products. Inspectors shall satisfy themselves that all such requirements are met before issuing such an export certificate. It shall be the responsibility of the exporter to provide any unofficial documentation needed to meet the foreign requirements, before the export certificate will be issued. Such certificates may also cover articles exempted from definition as a poultry product under § 381.15 if they have been inspected and are certified under the regulations in part 362 of this chapter." 9:9:2.0.2.1.35.13.40.13,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,M,"Subpart M—Official Marks, Devices, and Certificates; Export Certificates; Certification Procedures",,§ 381.108 Official poultry inspection certificates; issuance and disposition.,FSIS,,,"[37 FR 9706, May 16, 1972, as amended at 39 FR 36000, Oct. 7, 1974]","(a) Upon the request of an interested party, any veterinary inspector is authorized to issue an official poultry inspection certificate with respect to any lot of slaughtered poultry inspected by him. At any official establishment each such certificate shall be signed by the inspector who made the inspection covered by the certificate, and if more than one inspector participated in the inspection of the lot of poultry, each such inspector shall sign the certificate with respect to such lot. If the inspection of a lot covered by a certificate was made by a food inspector, such certificate shall also be signed by the inspector in charge when such inspection was made. Any inspector is authorized to issue a poultry inspection certificate with respect to any other poultry product inspected by him. (b) The original and one copy of each poultry inspection certificate shall be issued to the applicant who requested such certificate, and one copy shall be retained by the inspector for filing. The inspector who issues any inspection certificate is authorized to furnish an additional copy of such certificate upon the request of an interested party. The person who sold the live poultry involved to the official establishment is an interested party for purposes of this section." 9:9:2.0.2.1.35.13.40.14,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,M,"Subpart M—Official Marks, Devices, and Certificates; Export Certificates; Certification Procedures",,§ 381.109 Form of official poultry inspection certificate.,FSIS,,,,"(a) The official poultry inspection certificate authorized by this subpart is a paper certificate (Form MP-505) for signature by an inspector, bearing the legend 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 Regulations 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 receiver or buyer and the net weight in pounds of amount passed, amount rejected or condemned, type of poultry, lot number and class, and such other information as the Administrator may prescribe or approve in specific cases." 9:9:2.0.2.1.35.13.40.15,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,M,"Subpart M—Official Marks, Devices, and Certificates; Export Certificates; Certification Procedures",,§ 381.110 Erasures or alterations made on certificates.,FSIS,,,,"Erasures or alterations not initialed by the issuing inspector shall not be permitted on any official certificate or any copy thereof. All certificates rendered useless through clerical error or otherwise and all certificates canceled for whatever cause shall be voided and initialed, and one copy shall be retained in the inspector's file; and the original and all other copies shall be forwarded to the appropriate program supervisor." 9:9:2.0.2.1.35.13.40.16,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,M,"Subpart M—Official Marks, Devices, and Certificates; Export Certificates; Certification Procedures",,§ 381.111 Data to be entered in proper spaces.,FSIS,,,,All certificates shall be so executed that the data entered thereon will appear in the proper spaces on each copy of the certificate. 9:9:2.0.2.1.35.13.40.17,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,M,"Subpart M—Official Marks, Devices, and Certificates; Export Certificates; Certification Procedures",,§ 381.112 Official mark for maintaining the identity and integrity of samples.,FSIS,,,"[52 FR 41958, Nov. 2, 1987]","The official mark for use in sealing containers of samples submitted under any requirements in this part and section 11(b) of the Poultry Products Inspection Act shall bear the designation “Sample Seal” accompanied by the official USDA logo as shown below. Any seal approved by the Administrator for applying such mark shall be deemed an official device for purposes of the Act. Such device shall be supplied to inspectors, compliance officers, and other designated Agency officials by the United States Department of Agriculture." 9:9:2.0.2.1.35.13.40.2,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,M,"Subpart M—Official Marks, Devices, and Certificates; Export Certificates; Certification Procedures",,§ 381.97 [Reserved],FSIS,,,, 9:9:2.0.2.1.35.13.40.3,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,M,"Subpart M—Official Marks, Devices, and Certificates; Export Certificates; Certification Procedures",,§ 381.98 Official seal.,FSIS,,,,"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." 9:9:2.0.2.1.35.13.40.4,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,M,"Subpart M—Official Marks, Devices, and Certificates; Export Certificates; Certification Procedures",,§ 381.99 Official retention and rejection tags.,FSIS,,,"[64 FR 56417, Oct. 20, 1999]","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. Retained” for use on poultry or poultry products under this section. (b) A paper tag (another portion of Form C&MS 510) bearing the legend “U.S. Rejected” for use on equipment, utensils, rooms and compartments under this section." 9:9:2.0.2.1.35.13.40.5,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,M,"Subpart M—Official Marks, Devices, and Certificates; Export Certificates; Certification Procedures",,§ 381.100 Official detention tag.,FSIS,,,,The detention tag prescribed in § 381.211 is an official device. 9:9:2.0.2.1.35.13.40.6,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,M,"Subpart M—Official Marks, Devices, and Certificates; Export Certificates; Certification Procedures",,§ 381.101 Official U.S. Condemned mark.,FSIS,,,,The term “U.S. Condemned” as shown below is an official mark and the devices used by the Department for applying such mark are official devices. 9:9:2.0.2.1.35.13.40.7,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,M,"Subpart M—Official Marks, Devices, and Certificates; Export Certificates; Certification Procedures",,§ 381.102 [Reserved],FSIS,,,, 9:9:2.0.2.1.35.13.40.8,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,M,"Subpart M—Official Marks, Devices, and Certificates; Export Certificates; Certification Procedures",,§ 381.103 Official poultry condemnation certificates; issuance and form.,FSIS,,,,"Upon request by the operator of the establishment, the inspector in charge shall issue a poultry condemnation certificate (Form MP-514-1), showing the total number of poultry in the lot and the numbers condemned and the reasons for such condemnations. The official poultry condemnation certificate authorized by this subpart is a paper certificate (Form MP-514-1), for signature by an inspector, bearing the legend and the seal of the United States Department of Agriculture, with a certification that the poultry enumerated on the form were inspected and condemned for the listed causes in compliance with the regulations of the Department. A statement to the effect that certain figures on the certificate were derived from information supplied by plant management, and a signature line for an authorized plant official is also shown." 9:9:2.0.2.1.35.13.40.9,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,M,"Subpart M—Official Marks, Devices, and Certificates; Export Certificates; Certification Procedures",,§ 381.104 Export inspection marks.,FSIS,,,"[81 FR 42234, June 29, 2016]","The export inspection mark required in § 381.105 must be either a mark that contains a unique identifier that links the consignment to the export certificate or an official mark with the following form: 1 1 The number “1234567” is given as an example only. The number on the mark will correspond to the printed number on the export certificate." 9:9:2.0.2.1.35.14.40.1,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,N,Subpart N—Labeling and Containers,,§ 381.115 Containers of inspected and passed poultry products required to be labeled.,FSIS,,,,"Except as may be authorized in specific cases by the Administrator with respect to shipment of poultry products between official establishments, each shipping container and each immediate container of any inspected and passed poultry product shall at the time it leaves the official establishment bear a label which contains information, and has been approved, in accordance with this subpart." 9:9:2.0.2.1.35.14.40.10,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,N,Subpart N—Labeling and Containers,,§ 381.123 Official inspection mark; official establishment number.,FSIS,,,"[47 FR 29515, July 7, 1982]","The immediate container of every inspected and passed poultry product shall bear: (a) The official inspection legend; and (b) The official establishment number of the official establishment in which the product was processed under inspection and placed as follows: (1) Within the official inspection legend in the form required by subpart M of this part; or (2) Outside the official inspection legend elsewhere on the exterior of the container or its labeling, e.g., the lid of a can, if shown in a prominent and legible manner in a size sufficient to insure easy visibility and recognition and accompanied by the prefix “P”; or (3) Off the exterior of the container, e.g., on a metal clip used to close casings or bags, or on the back of a paper label of a canned product, or on other packaging or labeling in the container, e.g., on aluminum pans and trays placed within containers, when a statement of its location is printed contiguous to the official inspection legend, such as “Plant No. on Package Closure” or “Plant No. on Pan”, if shown in a prominent and legible manner in a size sufficient to ensure easy visibility and recognition; or (4) On an insert label placed under a transparent covering if clearly visible and legible and accompanied by the prefix “P”." 9:9:2.0.2.1.35.14.40.11,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,N,Subpart N—Labeling and Containers,,§ 381.124 Dietary food claims.,FSIS,,,,"If a product purports to be or is represented for any special dietary use by man, its label shall bear a statement concerning its vitamin, mineral, and other dietary properties upon which the claim for such use is based in whole or in part and shall be in conformity with regulations (21 CFR part 125) established pursuant to sections 403 and 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343, 371)." 9:9:2.0.2.1.35.14.40.12,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,N,Subpart N—Labeling and Containers,,§ 381.125 Special handling label requirements.,FSIS,,,"[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 59 FR 14540, Mar. 28, 1994; 64 FR 746, Jan. 6, 1999]","(a) Packaged products which require special handling to maintain their wholesome condition shall have prominently displayed on the principal display panel of the label the statement: “Keep Refrigerated,” “Keep Frozen,” “Keep Refrigerated or Frozen,” “Perishable—Keep Under Refrigeration,” or such similar statement as the Administrator may approve in specific cases. The immediate containers for products that are frozen during distribution and intended to be thawed prior to or during display for sale shall bear the statement “Shipped/Stored and Handled Frozen for Your Protection, Keep Refrigerated or Freeze.” For all canned perishable products, the statement shall be shown in upper case letters one-fourth inch in height for containers having a net weight of 3 pounds or less, and for containers having a net weight over 3 pounds, the statement shall be shown in letters one-half inch in height. (b) Safe handling instructions shall be provided for all poultry products not processed in accordance with the provisions of § 381.150(a) or that have not undergone other processing that would render them ready-to-eat, except as exempted under paragraph (b)(4) of this section. (1) (i) Safe handling instructions shall accompany the poultry products, specified in this paragraph (b), destined for household consumers, hotels, restaurants, or similar institutions and shall appear on the label. The information shall be in lettering no smaller than one-sixteenth of an inch in size and shall be prominently placed with such conspicuousness (as compared with other words, statements, designs or devices in the labeling) as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. (ii) The safe handling information shall be presented on the label under the heading “Safe Handling Instructions” which shall be set in type size larger than the print size of the rationale statement and handling statements as discussed in paragraphs (b)(2) and (b)(3) of this section. The safe handling information shall be set off by a border and shall be one color type printed on a single color contrasting background whenever practical. (2) (i) The labels of the poultry products, specified in this paragraph (b) and prepared from inspected and passed poultry, shall include the following rationale statement as part of the safe handling instructions, “This product was prepared from inspected and passed meat and/or poultry. Some food products may contain bacteria that could cause illness if the product is mishandled or cooked improperly. For your protection, follow these safe handling instructions.” This statement shall be placed immediately after the heading and before the safe handling statements. (ii) The labels of the poultry products, specified in this paragraph (b) and prepared pursuant to § 381.10(a) (2), (5), (6), and (7), shall include the following rationale statement as part of the safe handling instructions, “Some food products may contain bacteria that could cause illness if the product is mishandled or cooked improperly. For your protection, follow these safe handling instructions.” This statement shall be placed immediately after the heading and before the safe handling statements. (3) Poultry products, specified in this paragraph (b), shall bear the labeling statements. (i) Keep refrigerated or frozen. Thaw in refrigerator or microwave. (Any portion of this statement that is in conflict with the product's specific handling instructions may be omitted, e.g., instructions to cook without thawing.) (A graphic illustration of a refrigerator shall be displayed next to the statement.); (ii) Keep raw meat and poultry separate from other foods. Wash working surfaces (including cutting boards), utensils, and hands after touching raw meat or poultry. (A graphic illustration of soapy hands under a faucet shall be displayed next to the statement.); (iii) Cook thoroughly. (A graphic illustration of a skillet shall be displayed next to the statement.); and (iv) Keep hot foods hot. Refrigerate leftovers immediately or discard. (A graphic illustration of a thermometer shall be displayed next to the statement.) (4) Poultry products intended for further processing at another official establishment are exempt from the requirements prescribed in paragraphs (b)(1) through (b)(3) of this section." 9:9:2.0.2.1.35.14.40.13,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,N,Subpart N—Labeling and Containers,,§ 381.126 Date of packing and date of processing; contents of cans.,FSIS,,,"[37 FR 9706, May 16, 1972, as amended at 39 FR 28516, Aug. 8, 1974; 39 FR 35784, Oct. 4, 1974]","(a) Either the immediate container or the shipping container of all poultry food products shall be plainly and permanently marked by code or otherwise with the date of packing. If calendar dating is used, it must be accompanied by an explanatory statement, as provided in § 381.129(c)(2). (b) The immediate container for dressed poultry shall be marked with a lot number which shall be the number of the day of the year on which the poultry was slaughtered or a coded number. (c) All canned products shall be plainly and permanently marked, by code or otherwise, on the containers, with the identity of the contents and date of canning, except that canned products packed in glass containers are not required to be marked with the date of canning if such information appears on the shipping container. If calendar dating is used, it must be accompanied by an explanatory statement, as provided in § 381.129(c)(2). (d) If any marking is by code, the inspector in charge shall be informed as to its meaning." 9:9:2.0.2.1.35.14.40.14,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,N,Subpart N—Labeling and Containers,,§ 381.127 Wording on labels of shipping containers.,FSIS,,,,"(a) Each label for use on a shipping container for inspected and passed poultry products shall bear, in distinctly legible form, the following information: (1) The official inspection legend. (2) The official establishment number of the official establishment in which the poultry product was inspected, either within the official inspection mark, or elsewhere on the container clearly visible and in proximity to the official inspection mark." 9:9:2.0.2.1.35.14.40.15,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,N,Subpart N—Labeling and Containers,,§ 381.128 Labels in foreign languages.,FSIS,,,,"Any label to be affixed to a container of any dressed poultry or other poultry product for foreign commerce may be printed in a foreign language. However, the official inspection legend and establishment number shall appear on the label in English, but in addition, may be literally translated into such foreign language. Each such label shall be subject to the applicable provisions of §§ 381.115 to 381.141, inclusive. Deviations from the form of labeling required under the regulations may be approved by the Administrator in specific cases and such modified labeling may be used for poultry products to be exported: Provided, (a) That the proposed labeling accords to the specifications of the foreign purchaser, (b) that it is not in conflict with the Act or the laws of the country to which it is intended for export, and (c) that the outside of the shipping container is labeled to show that it is intended for export; but if such product is sold or offered for sale in domestic commerce, all the requirements of the regulations shall apply." 9:9:2.0.2.1.35.14.40.16,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,N,Subpart N—Labeling and Containers,,§ 381.129 False or misleading labeling or containers.,FSIS,,,"[37 FR 9706, May 16, 1972, as amended at 39 FR 28516, Aug. 8, 1974; 39 FR 42339, Dec. 5, 1974; 55 FR 5977, Feb. 21, 1990; 60 FR 44412, Aug. 25, 1995; 61 FR 66200, Dec. 17, 1996; 61 FR 68821, Dec. 30, 1996; 66 FR 54916, Oct. 31, 2001; 73 FR 50703, Aug. 28, 2008; 76 FR 82078, Dec. 30, 2011; 78 FR 66838, Nov. 7, 2013; 79 FR 49637, Aug. 21, 2014; 89 FR 19495, Mar. 18, 2024]","(a) No poultry product subject to the Act shall have any false or misleading labeling or any container that is so made, formed, or filled as to be misleading. However, established trade names and other labeling and containers which are not false or misleading and which are approved by the Administrator in the regulations or in specific cases are permitted. (b) No statement, word, picture, design, or device which is false or misleading in any particular or conveys any false impression or gives any false indication of origin, identity, or quality, shall appear on any label. For example: (1) Official grade designations such as the letter grades A, B, and C may be used in labeling individual carcasses of poultry or containers of poultry products only if such articles have been graded by a licensed grader of the Federal or Federal-State poultry grading service and found to qualify for the indicated grade. (2) Statements, words, pictures, designs, or devices having geographical significance with reference to a particular locality must be made in accordance with § 317.8(b)(1) of this chapter. (3) “Fresh frozen”, “quick frozen”, “frozen fresh”, and terms of similar import apply only to ready-to-cook poultry processed in accordance with § 381.66(f)(1). Ready-to-cook poultry handled in any other manner and dressed poultry may be labeled “frozen” only if it is frozen in accordance with § 381.66(f)(2) under Department supervision and is in fact in a frozen state. “Individually quick frozen (Kind)” and terms of similar import are applicable only to poultry products that are frozen as stated on the label and whose component parts can be easily separated at time of packing. (4) Poultry products labeled with a term quoted in any paragraph of § 381.170(b) shall comply with the specifications in the applicable paragraph. However, parts of poultry may be cut in any manner the processor desires as long as the labeling appropriately reflects the contents of the container of such poultry. (5) The terms “All,” “Pure,” “100%,” and terms of similar connotation shall not be used on labels for products to identify ingredient content, unless the product is prepared solely from a single ingredient. (6)(i) A raw poultry product whose internal temperature has ever been below 26 °F may not bear a label declaration of “fresh.” A raw poultry product bearing a label declaration of “fresh” but whose internal temperature has ever been below 26 °F is mislabeled. The temperature of individual packages of raw poultry product within an official establishment may deviate below the 26 °F standard by 1 degree (i.e., have a temperature of 25 °F) and still be labeled “fresh.” The temperature of individual packages of raw poultry product outside an official establishment may deviate below the 26 °F standard by 2 degrees (i.e., have a temperature of 24 °F) and still be labeled “fresh.” The average temperature of poultry product lots of each specific product type must be 26 °F. Product described in this paragraph is not subject to the freezing procedures required in § 381.66(f)(2) of this subchapter. (ii) Raw poultry product whose internal temperature has ever been at or below 0°F must be labeled with the descriptive term “frozen,” except when such labeling duplicates or conflicts with the labeling requirements in § 381.125 of this subchapter. The word “previously” may be placed next to the term “frozen” on an optional basis. The descriptive term must be prominently displayed on the principal display panel of the label. If additional labeling containing the descriptive term is affixed to the label, it must be prominently affixed to the label. The additional labeling must be so conspicuous (as compared with other words, statements, designs, or devices in the labeling) that it is likely to be read and understood by the ordinary individual under customary conditions of purchase and use. Product described in this paragraph is subject to the freezing procedures required in § 381.66(f)(2) of this subchapter. (iii) Raw poultry product whose internal temperature has ever been below 26 °F, but is above 0 °F, is not required to bear any specific descriptive term. Raw poultry product whose internal temperature has ever been below 26 °F, but is above 0 °F, may bear labeling with an optional, descriptive term, provided the optional, descriptive term does not cause the raw poultry product to become misbranded. If used, an optional, descriptive term must be prominently displayed on the principal display panel of the label. If additional labeling containing the optional, descriptive term is affixed to the label, it must be prominently affixed on the label. The additional labeling must be so conspicuous (as compared with other words, statements, designs, or devices in the labeling) that it is likely to be read and understood by the ordinary individual under customary conditions of purchase and use. (iv) Handling and relabeling of products. (A) Except as provided under paragraph (b)(6)(iii)(C) of this section, when any inspected and passed product has become misbranded under this subpart after it has been transported from an official establishment, such product may be transported in commerce to an official establishment after oral permission is obtained from the Area Supervisor of the area in which that official establishment is located. The transportation of the product may be to the official establishment from which it had been transported or to another official establishment designated by the person desiring to handle the product. The transportation shall be authorized only for the purpose of the relabeling of the product. The Area Supervisor shall record the authorization and other information necessary to identify the product and shall provide a copy of the record to the inspector at the establishment receiving the product. The shipper shall be furnished a copy of the authorization record upon request. (B) Upon the arrival of the shipment at the official establishment, a careful inspection shall be made of the product by the inspector, and if it is found that the product is not adulterated, it may be received into the establishment; but if the product is found to be adulterated, it shall at once be condemned and disposed of in accordance with § 381.95 of this subchapter. Wholesome product will be relabeled in accordance with paragraph (b)(6) (i) or (ii) of this section, as appropriate. (C) When any inspected and passed product has become misbranded under this subpart after it has been transported from an official establishment, the owner may transport the product in commerce to a retail entity for relabeling in accordance with paragraph (b)(6) (i) or (ii) of this section, as appropriate, or to other end users, such as hotels, restaurants or similar institutions; or, relabel the product in accordance with paragraph (b)(6) (i) or (ii) of this section, as appropriate if the product is already at a retail entity. A hotel, restaurant or similar institution is not required to relabel product misbranded under this subpart; Provided, That the product is prepared in meals or as entrees only for sale or service directly to individual consumers at such institutions, and that the mark of inspection is removed or obliterated. Oral permission shall be obtained from the Area Officer-in-Charge of the Compliance Program for the area in which the product is located prior to such transportation or relabeling. The Area Officer-in-Charge shall record the authorization and other information necessary to identify the product, and shall furnish a copy of the authorization record upon request. Before being offered for sale at a retail entity, such product shall be relabeled. (v) Ready-to-cook chicken may bear the claim “air chilled” or “air chilling” on its label only if the product was chilled under a process that meets the definition of air chilling in § 381.66(e). (c) A calendar date may be shown on labeling when declared in accordance with the provisions of this paragraph: (1) The calendar date shall express the month of the year and the day of the month for all products and also the year in the case of products hermetically sealed in metal or glass containers, dried or frozen products, or any other products that the Administrator finds should be labeled with the year because the distribution and marketing practices with respect to such products may cause a label without a year identification to be misleading. (2) Immediately adjacent to the calendar date will be a phrase explaining the meaning of such date in terms of “packing” date, “sell by” date, or “use before” date, with or without a further qualifying phrase, e.g., “For Maximum Freshness” or “For Best Quality.” (d) When sodium alginate, calcium carbonate, lactic acid, and calcium lactate are used together in a dry binding matrix in ground or formed poultry products, as permitted in § 424.21(c) of subchapter E, there shall appear on the label contiguous to the product name a statement to indicate the use of sodium alginate, calcium carbonate, lactic acid, and calcium lactate. (e) When transglutaminase enzyme is used to bind pieces of poultry to form a cut of poultry, or to reform a piece of poultry from a multiple cuts of poultry, there shall appear on the label, as part of the product name, a statement that indicates that the product has been “formed” or “reformed,” in addition to other preparation steps, e.g., “Formed Turkey Thigh Roast” or “Reformed and Shaped Chicken Breast.” (f) A country of origin statement on the label of any poultry product “covered commodity” as defined in 7 CFR part 65, subpart A, that is to be sold by a “retailer,” as defined in 7 CFR 65.240, must comply with the requirements in 7 CFR 65.300 and 65.400." 9:9:2.0.2.1.35.14.40.17,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,N,Subpart N—Labeling and Containers,,§ 381.130 False or misleading labeling or containers; orders to withhold from use.,FSIS,,,,"If the Administrator has reason to believe that any marking or other labeling or the size or form of any container in use or proposed for use with respect to any article subject to the Act is false or misleading in any particular, he may direct that the use of the article be withheld unless it is modified in such manner as the Administrator may prescribe so that it will not be false or misleading. If the person using or proposing to use the labeling or container does not accept the determination of the Administrator, he may request a hearing, but the use of the labeling or container shall, if the Administrator so directs, be withheld pending hearing and final determination by the Secretary in accordance with applicable rules of practice. Any such determination with respect to the matter by the Secretary 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 Columbia 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." 9:9:2.0.2.1.35.14.40.18,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,N,Subpart N—Labeling and Containers,,§ 381.131 Preparation of labeling or other devices bearing official inspection marks without advance approval prohibited; exceptions.,FSIS,,,"[50 FR 21423, May 24, 1985]","(a) Except for the purposes of preparing and submitting a sample or samples of the same to the Administrator for approval, no brand manufacturer, printer, or other person shall cast, print, lithograph, or otherwise make any marking device containing any official mark or simulation thereof, or any label bearing any such mark or simulation, without the written authority therefor of the Administrator. However, when any such sample label, or other marking device, is approved by the Administrator, additional supplies of the approved label, or marking device, may be made for use in accordance with the regulations in this subchapter, without further approval by the Administrator. The provisions of this paragraph do not apply to marking devices containing the official inspection legend shown in Figure 5 of § 381.102. (b) No brand manufacturer or other person shall cast or otherwise make, without an official certificate issued in quadruplicate by a Program employee, a marking device containing the official inspection legend shown in Figure 5 of § 381.102 or any simulation of that legend. (1) The certificate is a Food Safety and Inspection Service form for signature by a Program employee and the official establishment ordering the marking device, bearing a certificate serial number and a letterhead and the seal of the United States Department of Agriculture. The certificate authorizes the making of only the devices of the type and quantity listed on the certificate. (2) After signing the certificate, the Program employee and the establishment shall each keep a copy, and the remaining two copies shall be given to the marking device manufacturer. (3) The manufacturer of the marking devices shall engrave or otherwise mark each marking device with a permanent identifying serial number unique to it. The manufacturer shall list on each of the two copies of the certificate given to the manufacturer the number of each marking device authorized by the certificate. The manufacturer shall retain one copy of the certificate for the manufacturer's records and return the remaining copy with the marking devices to the Program employee whose name and address are given on the certificate as the recipient. (4) In order that all such marking devices bear identifying numbers, within one year after June 24, 1985, an establishment shall either replace each such marking device that does not bear an identifying number, or, under the direction of the inspector-in-charge, mark such marking device with a permanent identifying number." 9:9:2.0.2.1.35.14.40.19,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,N,Subpart N—Labeling and Containers,,§§ 381.132-381.133 [Reserved],FSIS,,,, 9:9:2.0.2.1.35.14.40.2,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,N,Subpart N—Labeling and Containers,,§ 381.116 Wording on labels of immediate containers.,FSIS,,,"[37 FR 9706, May 16, 1972, as amended at 40 FR 11347, Mar. 11, 1975; 59 FR 40214, Aug. 8, 1994]","(a) Each label for use on immediate containers for inspected and passed poultry products shall bear on the principal display panel (except as otherwise permitted in the regulations), the items of information required by this subpart. Such items of information shall be in distinctly legible form. Except as provided in § 381.128, all words, statements and other information required by or under authority of the Act to appear on the label or labeling shall appear thereon in the English language: Provided, however, That in the case of products distributed solely in Puerto Rico, Spanish may be substituted for English for all printed matter except the USDA inspection legend. (b) The principal display panel shall be the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for sale. The principal display panel shall be large enough to accommodate all the mandatory label information required to be placed thereon by the regulations with clarity and conspicuousness and without being obscured by design or vignettes, or crowding. Where packages bear alternate principal display panels, information required to be placed on the principal display panel shall be duplicated on each principal display panel. The area that is to bear the principal display panel shall be: (1) In the case of a rectangular package, one entire side, the area of which is the product of the height times the width of that side. (2) In the case of a cylindrical or nearly cylindrical container: (i) An area on the side of the container that is 40 percent of the product of the height of the container times the circumference, or (ii) A panel, the width of which is one-third of the circumference and the height of which is as high as the container: Provided, however, That there is, immediately to the right or left of such principal display panel, a panel which has a width not greater than 20 percent of the circumference and a height as high as the container, and which is reserved for information prescribed in §§ 381.118, 381.122, and 381.123. Such panel shall be known as the “20 percent panel” and such information may be shown on that panel in lieu of showing it on the principal display panel as provided in this § 381.116. (3) In the case of a container of any other shape, 40 percent of the total surface of the container. In determining the area of the principal display panel, exclude tops, bottoms, flanges at tops and bottoms of cans, and shoulders and necks of bottles or jars. (c) (1) The information panel is that part of a label that is the first surface to the right of the principal display panel as observed by an individual facing the principal display panel, with the following exceptions: (i) If the first surface to the right of the principal display panel is too small to accommodate the required information or is otherwise unusable label space, e.g., folded flaps, tear strips, opening flaps, heat-sealed flaps, the next panel to the right of this part of the label may be used. (ii) If the package has one or more alternate principal display panels, the information panel is to the right of any principal display panel. (iii) If the top of the container is the principal display panel and the package has no alternate principal display panel, the information panel is any panel adjacent to the principal display panel. (2) (i) Except as otherwise permitted in this part, all information required to appear on the principal display panel or permitted to appear on the information panel shall appear on the same panel unless there is insufficient space. In determining the sufficiency of the available space, except as otherwise prescribed in this part, any vignettes, designs, and any other nonmandatory information shall not be considered. If there is insufficient space for all required information to appear on a single panel, it may be divided between the principal display panel and the information panel, provided that the information required by any given provision of this part, such as the ingredients statement, is not divided and appears on the same panel. (ii) All information appearing on the information panel pursuant to this section shall appear in one place without intervening material, such as designs or vignettes." 9:9:2.0.2.1.35.14.40.20,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,N,Subpart N—Labeling and Containers,,§ 381.134 Requirement of formulas.,FSIS,,,"[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 59 FR 45196, Sept. 1, 1994. Redesignated at 60 FR 67457, Dec. 29, 1995]","Copies of each label submitted for approval, shall when the Administrator requires in any specific case, be accompanied by a statement showing, by their common or usual names, the kinds and percentages of the ingredients comprising the poultry product and by a statement indicating the method or preparation of the product with respect to which the label is to be used. Approximate percentages may be given in cases where the percentages of ingredients may vary from time to time, if the limits of variation are stated." 9:9:2.0.2.1.35.14.40.21,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,N,Subpart N—Labeling and Containers,,§ 381.136 Affixing of official identification.,FSIS,,,,"(a) No official inspection legend or any abbreviation or other simulation thereof may be affixed to or placed on or caused to be affixed to or placed on any poultry product or container thereof, except by an inspector or under the supervision of an inspector or other person authorized by the Administrator, and no container bearing any such legend shall be filled except under such supervision. (b) No official inspection legend shall be used on any poultry product or other article which does not qualify for such mark under the regulations." 9:9:2.0.2.1.35.14.40.22,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,N,Subpart N—Labeling and Containers,,§ 381.137 Evidence of labeling and devices approval.,FSIS,,,"[60 FR 67458, Dec. 29, 1995]",No inspector shall authorize the use of any device bearing any official inspection legend unless he or she has on file evidence that such device has been approved in accordance with the provisions of this subpart. 9:9:2.0.2.1.35.14.40.23,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,N,Subpart N—Labeling and Containers,,§ 381.138 Unauthorized use or disposition of approved labeling or devices.,FSIS,,,,"(a) Labeling and devices approved for use pursuant to § 381.115 shall be used only for the purpose for which approved, and shall not be disposed of from the official establishment for which approved except with written approval of the Administrator. Any unauthorized use or disposition of approved labeling or devices bearing official inspection marks is prohibited and may result in cancellation of the approval. (b) Labeling and containers bearing any official inspection marks, with or without the official establishment number, may be transported from one official establishment to any other official establishment, only if such shipments are made with the prior authorization of the inspector in charge at point of origin, who will notify the inspector in charge at destination concerning the date of shipment, quantity, and type of labeling material involved. Approved labeling and containers may be moved without restriction under this part between official establishments operated by the same person if such labeling and containers are approved for use at all such establishments. No such material shall be used at the establishment to which it is shipped unless such use conforms with the requirements of this subpart." 9:9:2.0.2.1.35.14.40.24,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,N,Subpart N—Labeling and Containers,,§ 381.139 Removal of official identifications.,FSIS,,,,"(a) Every person who receives any poultry product in containers which bear any official inspection legend shall remove or deface such legend or destroy the containers upon removal of such articles from the containers. (b) No person shall alter, detach, deface, or destroy any official identifications prescribed in subpart M that were applied pursuant to the regulations, unless he is authorized to do so by an inspector or this section; and no person shall fail to use any such official identification when required by this part." 9:9:2.0.2.1.35.14.40.25,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,N,Subpart N—Labeling and Containers,,§ 381.140 Relabeling poultry products.,FSIS,,,,"When it is claimed by the operator of an official establishment that some of its labeled poultry product, which has been transported to a location other than an official establishment, is in need of relabeling because the labeling has become mutilated or damaged, or for some other reason needs relabeling, the requests for relabeling the poultry product shall be sent to the Administrator and accompanied with a statement of the reasons therefor and the quantity of labeling required. Labeling material intended for relabeling inspected and passed product shall not be transported from an official establishment until permission has been received from the Administrator. The relabeling of inspected and passed product with official labels shall be done under the supervision of an inspector pursuant to the regulations in part 362 of this chapter. The establishment shall reimburse the Inspection Service for any cost involved in supervising the relabeling of such product as provided in said regulations." 9:9:2.0.2.1.35.14.40.26,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,N,Subpart N—Labeling and Containers,,§§ 381.141-381.143 [Reserved],FSIS,,,, 9:9:2.0.2.1.35.14.40.27,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,N,Subpart N—Labeling and Containers,,§ 381.144 Packaging materials.,FSIS,,,"[49 FR 2236, Jan. 19, 1984]","(a) Edible products may not be packaged in a container which is composed in whole or in part of any poisonous or deleterious substances which may render the contents adulterated or injurious to health. All packaging materials must be safe for the intended use within the meaning of section 409 of the Federal Food, Drug, and Cosmetic Act, as amended (FFDCA). (b) Packaging materials entering the official establishment must be accompanied or covered by a guaranty, or statement of assurance, from the packaging supplier under whose brand name and firm name the material is marketed to the official establishment. The guaranty shall state that the material's intended use complies with the FFDCA and all applicable food additive regulations. The guaranty must identify the material, e.g., by the distinguishing brand name or code designation appearing on the packaging material shipping container; must specify the applicable conditions of use, including temperature limits and other pertinent limits specified under the FFDCA and food additive regulations; and must be signed by an authorized official of the supplying firm. The guaranty may be limited to a specific shipment of an article, in which case it may be part of or attached to the invoice covering such shipment, or it may be general and continuing, in which case, in its application to any article or other shipment of an article, it shall be considered to have been given at the date such article was shipped by the person who gives the guaranty. Guaranties consistent with the Food and Drug Administration's regulations regarding such guaranties (21 CFR 7.12 and 7.13) will be acceptable. The management of the establishment must maintain a file containing guaranties for all food contact packaging materials in the establishment. The file shall be made available to Program inspectors or other Department officials upon request. While in the official establishment, the identity of all packaging materials must be traceable to the applicable guaranty. (c) The guaranty by the packaging supplier will be accepted by Program inspectors to establish that the use of material complies with the FFDCA and all applicable food additive regulations. (d) The Department will monitor the use of packaging materials in official establishments to assure that the requirements of paragraph (a) of this section are met, and may question the basis for any guaranty described under paragraph (b) of this section. Official establishments and packaging suppliers providing written guaranties to those official establishments will be permitted an opportunity to provide information to designated Department officials as needed to verify the basis for any such guaranty. The required information will include, but is not limited to, manufacturing firm's name, trade name or code designation for the material, complete chemical composition, and use. Selection of a material for review does not in itself affect a material's acceptability. Materials may continue to be used during the review period. However, if information requested from the supplier is not provided within the time indicated in the request—a minimum of 30 days—any applicable guaranty shall cease to be effective and approval to continue using the specified packaging material in official establishments may be denied. The Administrator may extend this time where reasonable grounds for extension are shown, as, for example, where data must be obtained from suppliers. (e) The Administrator may disapprove for use in official establishments packaging materials whose use cannot be confirmed as complying with the FFDCA and applicable food additive regulations. Before approval to use a packaging material is finally denied by the Administrator, the affected official establishment and the supplier of the material shall be given notice and the opportunity to present their views to the Administrator. If the official establishment and the supplier do not accept the Administrator's determination, a hearing in accordance with applicable rules of practice will be held to resolve such dispute. Approval to use the materials pending the outcome of the presentation of views or hearing shall be denied if the Administrator determines that such use may present an imminent hazard to public health. (f) Periodically, the Administrator will issue to inspectors a listing, by distinguishing brand name or code designation, of packaging materials that have been reviewed and that fail to meet the requirements of paragraph (a) of this section. Listed materials will not be permitted for use in official establishments. If a subsequent review of any material indicates that it meets the requirements of paragraph (a), the material will be deleted from the listing. (g) Nothing in this section shall affect the authority of Program inspectors to refuse a specific material if he/she determines the material may render products adulterated or injurious to health." 9:9:2.0.2.1.35.14.40.3,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,N,Subpart N—Labeling and Containers,,§ 381.117 Name of product and other labeling.,FSIS,,,"[37 FR 9706, May 16, 1972, as amended at 60 FR 55983, Nov. 3, 1995; 66 FR 40845, Aug. 6, 2001; 79 FR 79061, Dec. 31, 2014]","(a) The label shall show the name of the product, which, in the case of a poultry product which purports to be or is represented as a product for which a definition and standard of identity or composition is prescribed in subpart P, shall be the name of the food specified in the standard, and in the case of any other poultry product shall be the common or usual name of the food, if any there be, and if there is none, a truthful descriptive designation. (b) The name of the product required to be shown on labels for fresh or frozen raw whole carcasses of poultry shall be in either of the following forms: The name of the kind (such as chicken, turkey, or duck) preceded by the qualifying term “young” or “mature” or “old”, whichever is appropriate; or the appropriate class name as described in § 381.170(a). The name of the kind may be used in addition to the class name, but the name of the kind alone without the qualifying age or class term is not acceptable as the name of the product, except that the name “chicken” may be used without such qualification with respect to a ready-to-cook pack of fresh or frozen cut-up young chickens, or a half of a young chicken, and the name “duckling” may be used without such qualification with respect to a ready-to-cook pack of fresh or frozen young ducks. The class name may be appropriately modified by changing the word form, such as using the term “roasting chicken”, rather than “roaster.” The appropriate names for cut-up parts are set forth in § 381.170(b). When naming parts cut from young poultry, the identity of both the kind of poultry and the name of the part shall be included in the product name. The product name for parts or portions cut from mature poultry shall include, along with the part or portion name, the class name or the qualifying term “mature.” The name of the product for cooked or heat processed poultry products shall include the kind name of the poultry from which the product was prepared but need not include the class name or the qualifying term “mature.” (c) Poultry products containing light and dark chicken or turkey meat in quantities other than the natural proportions, as indicated in Table 1 in this paragraph, must have a qualifying statement in conjunction with the name of the product indicating, as shown in Table 1, the types of meat actually used, except that when the product contains less than 10 percent cooked deboned poultry meat or is processed in such a manner that the character of the light and dark meat is not distinguishable, the qualifying statement will not be required, unless the product bears a label referring to the light or dark meat content. In the latter case, the qualifying statement is required if the light and dark meat are not present in natural proportions. The qualifying statement must be in type at least one-half the size and of equal boldness as the name of the product; e.g., Boned Turkey (Dark Meat). Table 1 (d) Boneless poultry products shall be labeled in a manner that accurately describes their actual form and composition. The product name shall specify the form of the product (e.g., emulsified, finely chopped, etc.), and the kind name of the poultry, and if the product does not consist of natural proportions of skin and fat, as they occur in the whole carcass, shall also include terminology that describes the actual composition. If the product is cooked, it shall be so labeled. For the purpose of this paragraph, natural proportions of skin, as found on a whole chicken or turkey carcass, will be considered to be as follows: Boneless poultry product shall not have a bone solids content of more than 1 percent, calculated on a weight basis. (e) On the label of any “Mechanically Separated (Kind of Poultry) “ described in § 381.173, the name of such product shall be followed immediately by the phrase: “with excess skin” unless such product is made from poultry product that does not include skin in excess of the natural proportion of skin present on the whole carcass, as specified in paragraph (d) of this section. Appropriate terminology on the label shall indicate if heat treatment has been used in the preparation of the product. The labeling information described in this paragraph shall be identified on the label before the product leaves the establishment at which it is manufactured. (f) The labels of sausages encased in natural casings made from meat or poultry viscera shall identify the type of meat or poultry from which the casings were derived, if the casings are from a different type of meat or poultry than the encased meat or poultry. The identity of the casing, if required, may be placed on the principal display panel or in the ingredient statement. Establishments producing, manufacturing, or using natural sausage casings are to maintain records documenting the meat or poultry source in accordance with subpart Q of this part. (g) The labels of sausages encased in regenerated collagen casings shall disclose this fact on the product label. The fact that the sausage is encased in collagen may be placed on the principal display panel or in the ingredient statement. (h) The product name for a raw poultry product that contains added solution and does not meet a standard of identity in this part must contain a descriptive designation that includes: (1) The percentage of added solution (total weight of the solution ingredients divided by the weight of the raw poultry without solution or any other added ingredients multiplied by 100). The percentage of added solution must appear as a number (such as, 15, 20, 30) and the percent symbol (%). The percentage of added solution may be declared by the words “containing” or “contains” (such as, “contains 15% added solution of water and salt,” or “containing 15% added solution of water and teriyaki sauce”). (2) The common or usual name of all individual ingredients or multi-ingredient components in the solution listed in descending order of predominance by weight. (3) When the descriptive designation includes all ingredients in the solution, a separate ingredients statement is not required on the label. When the descriptive designation includes multi-ingredient components and the ingredients of the component are not declared in the product name, all ingredients in the product must be declared in a separate ingredients statement on the label as required in § 381.118. (4) The product name and the descriptive designation must be printed in a single easy-to-read type style and color and must appear on a single-color contrasting background. The print may appear in upper and lower case letters, with the lower case letters not smaller than one-third ( 1/3 ) the size of the largest letter. (5) The word “enhanced” cannot be used in the product name." 9:9:2.0.2.1.35.14.40.4,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,N,Subpart N—Labeling and Containers,,§ 381.118 Ingredients statement.,FSIS,,,"[37 FR 9706, May 16, 1972, as amended at 55 FR 7294, Mar. 1, 1990; 55 FR 26422, June 28, 1990; 58 FR 38049, July 15, 1993; 59 FR 40215, Aug. 8, 1994; 63 FR 11360, Mar. 9, 1998; 76 FR 82078, Dec. 30, 2011]","(a)(1) The label shall show a statement of the ingredients in the poultry product if the product is fabricated from two or more ingredients. Such ingredients shall be listed by their common or usual names in the order of their descending proportions, except as prescribed in paragraph (a)(2) of this section. (2)(i) Product ingredients which are present in individual amounts of 2 percent or less by weight may be listed in the ingredients statement in other than descending order of predominance: Provided, That such ingredients are listed by their common or usual names at the end of the ingredients statement and preceded by a quantifying statement, such as “Contains __________ percent or less of __________ ,” or “Less than __________ percent of __________ .” The percentage of the ingredient(s) shall be filled in with a threshold level of 2 percent, 1.5 percent, 1.0 percent, or 0.5 percent, as appropriate. No ingredient to which the quantifying statement applies may be present in an amount greater than the stated threshold. Such a quantifying statement may also be utilized when an ingredients statement contains a listing of ingredients by individual components. Each component listing may utilize the required quantifying statement at the end of each component ingredients listing. (ii) Such ingredients may be adjusted in the product formulation without a change being made in the ingredients statement on the labeling, provided that the adjusted amount complies with subpart P of this part and § 424.21(c) of subchapter E, and does not exceed the amount shown in the quantifying statement. Any such adjustments to the formulation shall be provided to the inspector-in-charge. (b) For the purpose of this paragraph, the term “chicken meat,” unless modified by an appropriate adjective, is construed to mean deboned white and dark meat; whereas the term “chicken” may include other edible parts such as skin and fat not in excess of their natural proportions, in addition to the chicken meat. If the term “chicken meat” is listed and the product also contains skin, giblets, or fat, it is necessary to list each such ingredient. Similar principles shall be followed in listing ingredients of poultry products processed from other kinds of poultry. (c) The terms spice, natural flavor, natural flavoring, flavor or flavoring may be used in the following manner: (1) The term “spice” means any aromatic vegetable substance in the whole, broken, or ground form, with the exceptions of onions, garlic and celery, whose primary function in food is seasoning rather than nutritional and from which no portion of any volatile oil or other flavoring principle has been removed. Spices include the spices listed in 21 CFR 182.10, and 184. (2) The term “natural flavor,” “natural flavoring,” “flavor” or “flavoring” means the essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product of roasting, heating or enzymolysis, which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or any other edible portions of a plant, meat, seafood, poultry, eggs, dairy products, or fermentation products thereof, whose primary function in food is flavoring rather than nutritional. Natural flavors include the natural essence or extractives obtained from plants listed in 21 CFR 182.10, 182.20, 182.40, 182.50 and 184, and the substances listed in 21 CFR 172.510. The term natural flavor, natural flavoring, flavor or flavoring may also be used to designate spices, powdered onion, powdered garlic, and powdered celery. (i) Natural flavor, natural flavoring, flavor or flavoring as described in paragraph (c)(1) and (2) of this section, which are also colors shall be designated as “natural flavor and coloring,” “natural flavoring and coloring,” “flavor and coloring” or “flavoring and coloring” unless designated by their common or usual name. (ii) Any ingredient not designated in paragraphs (c) (1) and (2) of this section whose function is flavoring, either in whole or in part, must be designated by its common or usual name. Those ingredients which are of livestock or poultry origin must be designated by names that include the species and livestock and poultry tissues from which the ingredients are derived. (d) On containers of frozen dinners, entrees, and pizzas, and similarly packaged products in cartons, the ingredient statement may be placed on the front riser panel: Provided, That the words “see ingredients,” followed immediately by an arrow pointing to the front riser panel, are placed on the principal display panel immediately above the location of such statement, without intervening printing or designs. (e) The ingredients statement may be placed on the information panel, except as otherwise permitted in this subchapter. (f) Establishments may interchange the identity of two kinds of poultry (e.g., chicken and turkey, chicken meat and turkey meat) used in a product formulation without changing the product's ingredient statement or product name under the following conditions: (1)(i) The two kinds of poultry used must comprise at least 70 percent by weight of the poultry and the poultry ingredients [e.g. giblets, skin or fat in excess of natural proportions, or mechanically separated (kind)] used; and, (ii) Neither of the two kinds of poultry used can be less than 30 percent by weight of the total poultry and poultry ingredients used; (2) The word “and” in lieu of a comma must be shown between the declaration of the two kinds of poultry in the ingredients statement and in the product name." 9:9:2.0.2.1.35.14.40.5,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,N,Subpart N—Labeling and Containers,,§ 381.119 Declaration of artificial flavoring or coloring.,FSIS,,,,"(a) When an artificial smoke flavoring or a smoke flavoring is added as an ingredient in the formula of any poultry product, there shall appear on the label, in prominent letters and contiguous to the name of the product, a statement such as “Artificial Smoke Flavoring Added” or “Smoke Flavoring Added,” as applicable, and the ingredient statement shall identify any artificial smoke flavoring or smoke flavoring added as an ingredient in the formula of the poultry product. (b) Any poultry product which bears or contains any artificial flavoring other than an artificial smoke flavoring or a smoke flavoring, or bears or contains any artificial coloring shall bear a statement stating that fact on the immediate container or, if there is none, on the product." 9:9:2.0.2.1.35.14.40.6,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,N,Subpart N—Labeling and Containers,,§ 381.120 Antioxidants; chemical preservatives; and other additives.,FSIS,,,"[37 FR 9706, May 16, 1972, as amended at 45 FR 58820, Sept. 5, 1980; 49 FR 18999, May 4, 1984; 64 FR 72175, Dec. 23, 1999]","When an antioxidant is added to a poultry product, there shall appear on the label in prominent letters and contiguous to the name of the product, a statement showing the name of the antioxidant and the purpose for which it is added, such as “BHA added to help protect the flavor.” Immediate containers of poultry products packed in, bearing, or containing any chemical preservative shall bear a label stating that fact and naming the additive and the purpose of its use. Immediate containers of poultry products packed in, bearing or containing any other chemical additive shall bear a label naming the additive and the purpose of its use when required by the Administrator in specific cases. When approved proteolytic enzymes as permitted in a regulation permitting that use in this subchapter or 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B of this subchapter are used in mature poultry muscle tissue, there shall appear on the label, in a prominent manner, contiguous to the product name, the statement “Tenderized with [approved enzyme],” to indicate the use of such enzymes. Any other approved substance which may be used in the solution shall also be included in the statement. When approved inorganic chlorides as permitted in a regulation permitting that use in this subchapter or 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B of this subchapter are used in mature poultry muscle tissue, there shall appear on the label, in a prominent manner, contiguous to the product name, the statement, “Tenderized with (name of approved inorganic chloride(s))” to indicate the use of such inorganic chlorides. Any other approved substance which may be used in the solution shall also be included in the statement." 9:9:2.0.2.1.35.14.40.7,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,N,Subpart N—Labeling and Containers,,§ 381.121 Quantity of contents.,FSIS,,,"[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 53 FR 28635, July 29, 1988; 55 FR 49835, Nov. 30, 1990; 87 FR 50556, Aug. 17, 2022]","(a) The label shall bear a statement of the quantity of contents in terms of weight or measures as provided in paragraph (c)(5) of this section. However, the Administrator may approve the use of labels for certain types of consumer packages which do not bear a statement of the net weight that would otherwise be required under this subparagraph: Provided, That the shipping container bears a statement “Net weight to be marked on consumer packages prior to display and sale”: And provided further, That the total net weight of the contents of the shipping container is marked on such container: And provided further, That the shipping container bears a statement “Tare weight of consumer package” and in close proximity thereto, the actual tare weight (weight of packaging material), weighed to the nearest one-eighth ounce or less, of the individual consumer package in the shipping container. The above-specified statements may be added to approved shipping container labels upon approval by the inspector in charge. (b) When a poultry product and a nonpoultry product are separately wrapped and are placed in a single immediate container bearing the same name of both products, the net weight on such immediate container may be the total net weight of the products, or such immediate container may show the net weights of the poultry product and the nonpoultry product separately. Notwithstanding the other provisions of this paragraph, the label on consumer size retail packages of stuffed poultry and other stuffed poultry products must show the total net weight of the poultry product, and in close proximity thereto, a statement specifying the minimum weight of the poultry in the product. (c)(1) The statement of net quantity of contents shall appear (except as otherwise permitted under this paragraph (c)), on the principal display panel of all containers to be sold at retail intact, in conspicuous and easily legible boldface print or type, in distinct contrast to other matter on the container, and shall be declared in accordance with the provisions of this paragraph (c). An unused tare weight, as defined in section 381.121b of this subchapter, may be printed adjacent to the statement of net quantity of contents when the product is packaged totally with impervious packaging material and is packed with a usable medium. (2) The statement shall be placed on the principal display panel within the bottom 30 percent of the area of the panel, in lines generally parallel to the base: Provided, That on packages having a principal display panel of 5 square inches or less, the requirement for placement within the bottom 30 percent of the area of the label panel shall not apply when the statement meets the other requirements of this paragraph. The declaration may appear in more than one line. (3) The statement shall be in letters and numerals in type size established in relationship to the area of the principal display panel of the package and shall be uniform for all packages of substantially the same size by complying with the following type specifications: (i) Not less than one-sixteenth inch in height on containers, the principal display panel of which has an area of 5 square inches or less; (ii) Not less than one-eighth inch in height on containers, the principal display panel of which has an area of more than 5 but not more than 25 square inches; (iii) Not less than three-sixteenth inch in height on containers, the principal display panel of which has an area of more than 25 but not more than 100 square inches; (iv) Not less than one-quarter inch in height on containers, the principal display panel of which has an area of more than 100 but not more than 400 square inches; (v) Not less than one-half inch in height on containers, the principal display panel of which has an area of more than 400 square inches. (vi) The ratio of height to width of letters and numerals shall not exceed a differential of 3 units to 1 unit (no more than 3 times as high as it is wide). This height standard pertains to upper case or capital letters. When upper and lower case or all lower case letters are used, it is the lower case letter “o” or its equivalent that shall meet the minimum standards. When fractions are used, each component numeral shall meet one-half the height standards. (4) The statement shall appear as a distinct item on the principal display panel and shall be separated, from other label information appearing to the left or right of the statement, by a space at least equal in width to twice the width of the letter “N” of the style of type used in the quantity of contents statement and shall be separated from other label information appearing above or below the statement by a space at least equal in height to the height of the lettering used in the statement. (5) The terms “net weight” or “net wt.” shall be used when stating the net quantity of contents in terms of weight, and the term “net contents” or “contents” when stating the net quantity of contents in terms of fluid measure. Except as provided in § 381.128, the statement shall be expressed in terms of avoirdupois weight or liquid measure. Where no general consumer usage to the contrary exists, the statement shall be in terms of liquid measure, if the product is liquid, or in terms of weight if the product is solid, semi-solid, viscous, or a mixture of solid and liquid. On packages containing less than 1 pound or 1 pint, the statement shall be expressed in ounces or fractions of a pint, respectively. On packages containing 1 pound or 1 pint or more, and less than 4 pounds or 1 gallon, the statement shall be expressed in ounces or in pounds with any remainder in terms of ounces or common or decimal fraction of the pound, or in the case of liquid measure, in the largest whole units with any remainder in terms of fluid ounces or common or decimal fraction of the pint or quart. For example, a declaration of three-fourths pound avoirdupois weight shall be expressed as “Net Wt. 12 oz.”; a declaration of 1 1/2 pounds avoirdupois weight shall be expressed as “Net Wt. 24 oz.,” “Net Wt. 1 lb. 8 oz.,” “Net Wt. 1 1/2 lb.,” or “Net Wt. 1.5 lbs.”. However, on random weight packages the statement shall be expressed in terms of pounds and decimal fractions of the pound, for packages over 1 pound, and for packages which do not exceed 1 pound the statement may be in decimal fractions of the pound in lieu of ounces. The numbers may be written in provided the unit designation is printed. Paragraphs (c)(8) and (9) of this section permit certain exceptions to this paragraph (c)(5) for multi-unit packages, and random weight consumer size and small packages (less than 1/2 ounce), respectively. (6) The statement as it is shown on a label shall not be false or misleading and shall express an accurate statement of the quantity of contents of the container. Reasonable variations caused by loss or gain of moisture during the course of good distribution practices or by unavoidable deviations in good manufacturing practices will be recognized. Variations from stated quantity of contents shall be as provided in section 381.121b of this subchapter. The statement shall not include any term qualifying a unit of weight, measure, or count such as “jumbo quart,” “full gallon,” “giant quart,” “when packed,” “minimum,” or words of similar importance except as provided in paragraph (b) of this section. (7) Labels for containers which bear any representation as to the number of servings contained therein shall bear, contiguous to such representation, and in the same size type as is used for such representation, a statement of the net quantity of each such serving. (8) On a multiunit retail package, a statement of the quantity of contents shall appear on the outside of the package and shall include the number of individual units, the quantity of each individual unit, and, in parentheses, the total quantity of contents of the multiunit package in terms of avoirdupois or fluid ounces. “A multiunit retail package” is a package containing two or more individually packaged units of the identical commodity and in the same quantity, with the individual packages intended to be sold as part of the multiunit retail package but capable of being sold individually. Open multiunit retail packages that do not obscure the number of units and the labeling thereon are not subject to this paragraph (c) (8) if the labeling of each individual unit complies with the requirements of this paragraph (c). (9) The following exemptions from the requirements contained in this section are hereby established: (i) Individually wrapped, random weight consumer size packages of poultry products (as specified in paragraph (c)(10) of this section) and poultry products that are subject to shrinkage through moisture loss during good distribution practices and are designated as gray area type of products as defined in NBS handbook 133, section 3.18.2, need not bear a net weight statement when shipped from an official establishment provided a net weight shipping statement which meets the requirements of paragraph (c)(6) of this section is applied to the shipping container prior to shipping it from the official establishment. Net weight statements so applied to the shipping container are exempt from the type size and placement requirements of this paragraph if an accurate statement of net weight is shown conspicuously on the principal display panel of the shipping container. The net weight also shall be applied directly to random weight consumer size packages prior to retail display and sale. The net weight statement of random weight consumer size packages for retail sale shall be exempt from the type size and placement requirements of this paragraph if an accurate statement of net weight is shown conspicuously on the principal display panel of the package. (ii) Individually wrapped and labeled packages of less than 1/2 ounce net weight and random weight consumer size packages shall be exempt from the requirements of this paragraph if they are in a shipping container and the statement of net quantity of contents on the shipping container meets the requirements of paragraph (c)(6) of this section; (iii) Individually wrapped and labeled packages of less than 1/2 ounce net weight bearing labels declaring net weight, price per pound, and total price, shall be exempt from the type size and placement requirements of this paragraph if an accurate statement of net weight is shown conspicuously on the principal display panel of the package. (10) As used in this section a “random weight consumer size package” is one of a lot, shipment or delivery of packages of the same product, with varying weights and with no fixed weight pattern." 9:9:2.0.2.1.35.14.40.8,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,N,Subpart N—Labeling and Containers,,§§ 381.121a-381.121e [Reserved],FSIS,,,, 9:9:2.0.2.1.35.14.40.9,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,N,Subpart N—Labeling and Containers,,"§ 381.122 Identification of manufacturer, packer or distributor.",FSIS,,,"[37 FR 9706, May 16, 1972, as amended at 59 FR 40215, Aug. 8, 1994]","The name and address, including zip code, of the manufacturer, packer, or distributor shall be shown on the label and if only the name and address of the distributor is shown, it shall be qualified by such term as “packed for,” “distributed by,” or “distributors.” The name and place of business of the manufacturer, packer, or distributor may be shown on the principal display panel, on the 20-percent panel of the principal display panel reserved for required information, on the front riser panel of frozen food cartons, or on the information panel." 9:9:2.0.2.1.35.15.40.1,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,O,Subpart O—Entry of Articles Into Official Establishments; Processing Inspection and Other Reinspections; Processing Requirements,,§ 381.145 Poultry products and other articles entering or at official establishments; examination and other requirements.,FSIS,,,"[37 FR 9706, May 16, 1972, as amended at 45 FR 54323, Aug. 15, 1980; 46 FR 48904, Oct. 5, 1981; 50 FR 6, Jan. 2, 1985; 51 FR 32304, Sept. 11, 1986; 57 FR 43598, Sept. 21, 1992; 62 FR 45026, Aug. 25, 1997; 62 FR 54759, Oct. 22, 1997; 64 FR 72175, Dec. 23, 1999; 65 FR 34390, May 30, 2000; 78 FR 66838, Nov. 7, 2013; 84 FR 65268, Nov. 27, 2019; 90 FR 27227, June 26, 2025]","(a) No poultry product (including poultry broth for use in any poultry product in any official establishment) may be brought into any official establishment unless it has been processed in the United States only in an official establishment or imported from a foreign country eligible to export such poultry and poultry products to the United States under § 381.196(b), and inspected and passed, in accordance with the regulations; and unless the container of such product is marked so as to identify the product as so inspected and passed, in accordance with § 381.115 or § 381.205, except that poultry products inspected and passed and identified as such under the laws of an “at least equal” State or territory listed in § 381.187 may be brought into any official establishment solely for storage and distribution therefrom without repackaging, relabeling, or processing in such establishment. No carcass, part thereof, meat or meat food product of cattle, sheep, swine, goats, or equines may be brought into an official establishment unless it has been prepared in the United States only in an official meat packing establishment, or imported, and inspected and passed, in accordance with the Federal Meat Inspection Act, and the regulations under such Act (Subchapter A of this chapter) and is properly marked as so inspected and passed; or has been inspected and passed and is identified as such in accordance with the requirements of the law and regulations of a State not designated under section 301(c) of the Act; or is present in the official establishment by reason of an exemption allowed in the Federal Meat Inspection Act and the regulations under such Act (Subchapter A of this chapter) or the law and regulations of a State not so designated. However, such exempted articles may enter only under conditions approved by the Administrator in specific cases, including but not limited to, complete separation of inspected poultry products and processing and other operations with respect thereto from the exempted articles and operations with respect thereto, complete cleanup of facilities and equipment between processing of inspected poultry products and the exempted articles and no commingling of inspected and exempted articles in receiving, holding or storage areas. (b) All poultry products and all carcasses, parts thereof, meat and meat food products of cattle, sheep, swine, goats, or equines which enter any official establishment shall be identified by the operator of the official establishment at the time of receipt at the official establishment. All poultry products, and all carcasses, parts thereof, meat and meat food products of such animals, which are processed or otherwise handled at any official establishment shall be subject to examination by an inspector at the official establishment in such manner and at such times as may be deemed necessary by the inspector in charge to assure compliance with the regulations. Upon such examination, if any such article or portion thereof is found to be adulterated, such article or portion shall, in the case of poultry products, be condemned and disposed of as prescribed in § 381.95, unless by reprocessing they may be made not adulterated, and shall, in the case of such other articles be disposed of according to applicable law. Such examination may be accomplished through use of statistically sound sampling plans that assure a high level of confidence. The inspector in charge shall designate the type of plan and the program employee shall select the specific plan to be used in accordance with instructions issued by the Administrator. 1 1 Further information concerning sampling plans which have been adopted for specific products may be obtained from the Circuit Supervisor. These sampling plans are developed for individual products by the Washington staff and will be distributed for field use as they are developed. The type of plan applicable depends on factors such as whether the product is in containers, stage of preparation, and procedures followed by the establishment operator. The specific plan applicable depends on the kind of product involved. (c) Applying for Total Plant Quality Control. Any owner or operator of an official establishment preparing poultry product who has a total plant quality control system or plan for controlling such products, after ante-mortem and post-mortem inspection, through all stages of preparation, may request the Administrator to evaluate it to determine whether or not that system is adequate to result in product being in compliance with the requirements of the Act and therefore qualify as a U.S. Department of Agriculture (USDA) Total Plant Quality Control Establishment. Such a request shall, as a minimum, include: (1) A letter to the Administrator from the establishment owner or operator stating the company's basis and purpose for seeking an approved quality control system and willingness to adhere to the requirements of the system as approved by the Department; that all the establishment's data, analyses, and information generated by its quality control system will be maintained to enable the Department to monitor compliance and available to Department personnel; that plant quality control personnel will have authority to halt production or shipping of product in cases where the submitted quality control systems require it; and that the owner or operator (or his/her designee) will be available for consultation at any time Department personnel consider it necessary. (2) In the case of an establishment having one or more full-time persons whose primary duties are related to the quality control system, an organizational chart showing that such people ultimately report to an establishment official whose quality control responsibilities are independent of or not predominantly production responsibilities. In the case of a small establishment which does not have full-time quality control personnel, information indicating the nature of the duties and responsibilities of the person who will also be responsible for the quality control system. (3) A list identifying those subparts and sections of the poultry products inspection regulations which are applicable to the operations of the establishment applying for approval of a quality control system. This list shall also identify which part of the system will serve to maintain compliance with the applicable regulations. (4) Detailed information concerning the manner in which the system will function. Such information should include, but not necessarily be limited to, questions of raw material control, the critical check or control points, the nature and frequency of tests to be made, the nature of charts and other records that will be used, the length of time such charts and records will be maintained in the custody of the official establishment, the nature of deficiencies the quality control system is designed to identify and control, the parameters of limits which will be used and the points at which corrective action will occur, and the nature of such corrective action—ranging from the least to most severe: Provided, That subsequent to approval of the total plant quality control system by the Administrator, the official establishment may produce a new product for test marketing provided labeling for the product has been approved by the Administrator, the inspector in charge has determined that the procedures for preparing the product will assure that all Federal requirements are met, and the production for test marketing does not exceed 6 months. Such new product shall not be produced at that establishment after the 6-month period unless approval of the quality control system for that product has been received from the Administrator. (d)-(e) [Reserved] (f) Labeling Logo. Owners and operators of official establishments having a total plant quality control system approved under the provisions of paragraph (c) of this section may only use, as a part of any label, the following logo. (g) Termination of Quality Control Systems. (1) The approval of a total plant quality control system may be terminated at any time by the owner or operator of the official establishment upon written notice to the Administrator. (2) The approval of a total plant quality control system or a quality control system for irradiation facilities may be terminated upon the establishment's receipt of a written notice from the Administrator under the following conditions: (i) If adulterated or misbranded poultry product is found by the Adminstrator to have been prepared for or distributed in commerce by the subject establishment. In such case, opportunity will be provided to the establishment owner or operator to present views to the Administrator within 30 days of the date of terminating the approval. 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 approval shall remain in effect pending the final determination of the proceeding. (ii) If the establishment fails to comply with the quality control system to which it has agreed after being notified by letter from the Administrator or his designee. Prior to such termination, opportunity will be provided to the establishment owner or operator to present views to the Administrator 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 months from the termination date. (4) If approval of a quality control system for irradiation facilities, as specified in section 381.149 of this subpart, has been terminated in accordance with the provisions of this section, a request for approval of the same or a modified quality control system will be evaluated by the Administrator upon receipt. (h)(1) Operating Schedule Under Total Plant Quality Control. An official establishment with an approved total plant quality control system may request approval for an operating schedule of up to 12 consecutive hours per shift. Permissions will be granted provided that: (i) The official establishment has satisfactorily operated under a total plant quality control system for at least 1 year. (ii) All products prepared and packaged, or processed after the end of 8 hours of inspection shall only be a continuation of the processing monitored by the inspector and being conducted during the last hour of inspection. (iii) All immediate containers of products prepared and packaged shall bear code marks that are unique to any period of production beyond the 8 hours of inspection. The form of such code marks will remain constant from day to day, and a facsimile of the code marks and their meaning shall be provided to the inspector. (2) Application. Applications shall be submitted to the Regional Director and shall specify how the conditions in § 381.145(h)(1) have been or will be met. (3) Monitoring by Inspectors. In order to verify that an establishment is preparing and shipping product in accordance with the approved total plant quality control system and the Act and regulations after the 8 hours of inspection, the official establishment may be provided overtime inspectiom services at the discretion of the circuit supervisor and charged for such services. (i) To ensure the safe use of preparations used in poultry scald water, the label or labeling on containers of such preparations shall bear adequate directions to ensure use in compliance with any limitations prescribed in 21 CFR Chapter I, Subchapter A or Subchapter B or 9 CFR Chapter III, Subchapter A or Subchapter E." 9:9:2.0.2.1.35.15.40.2,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,O,Subpart O—Entry of Articles Into Official Establishments; Processing Inspection and Other Reinspections; Processing Requirements,,§ 381.146 Sampling at official establishments.,FSIS,,,,"Inspectors may take, without cost to the Department, such samples as are necessary of any poultry product, or other article for use as an ingredient of any poultry product, at any official establishment to determine whether it complies with the requirements of the regulations." 9:9:2.0.2.1.35.15.40.3,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,O,Subpart O—Entry of Articles Into Official Establishments; Processing Inspection and Other Reinspections; Processing Requirements,,§ 381.148 Processing and handling requirements for frozen poultry products.,FSIS,,,,"Procedures with respect to processing of frozen ready-to-heat-and-eat poultry products or stuffed ready-to-roast poultry shall be in accordance with sound operating practices and carried out in a manner which will assure freedom from adulteration of the products. Products to be frozen shall be moved into the freezer promptly under such supervision by an inspector as is necessary to assure preservation of the products by prompt and efficient freezing. Adequate freezing facilities shall be provided within the official establishment where products to be frozen are prepared, except that, upon written request, and under such conditions as may be prescribed by the Administrator in specific cases, such products may be moved from the official establishment prior to freezing: Provided, That the official establishment and freezer are so located and the necessary arrangements are made so that the Inspection Service will have access to the freezing room and adequate opportunity to determine that the products are being properly handled and frozen." 9:9:2.0.2.1.35.15.40.4,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,O,Subpart O—Entry of Articles Into Official Establishments; Processing Inspection and Other Reinspections; Processing Requirements,,§ 381.150 Requirements for the production of fully cooked poultry products and partially cooked poultry breakfast strips.,FSIS,,,"[64 FR 746, Jan. 6, 1999]","(a) Fully cooked poultry products must be produced using processes ensuring that the products meet the following performance standards: (1) Lethality. A 7-log 10 reduction of Salmonella or an alternative lethality that achieves an equivalent probability that no viable Salmonella organisms remain in the finished product, as well as the reduction of other pathogens and their toxins or toxic metabolites necessary to prevent adulteration, must be demonstrated to be achieved throughout the product. The lethality process must include a cooking step. Controlled intermediate step(s) applied to raw product may form part of the basis for the equivalency. (2) Stabilization. There can be no multiplication of toxigenic microorganisms such as Clostridium botulinum, and no more than a 1 log 10 multiplication of Clostridium perfringens within the product. (b) Partially cooked poultry breakfast strips must be produced using processes ensuring that the products meet the performance standard listed in paragraph (a)(2) of this section. Labeling for these products must comply with § 381.125. In addition, the statement “Partially Cooked: For Safety, Cook Until Well Done” must appear on the principal display panel in letters no smaller than 1/2 the size of the largest letter in the product name. Detailed cooking instructions shall be provided on the immediate container of the products. (c) For each product produced using a process other than one conducted in accordance with the Hazard Analysis and Critical Control Point (HACCP) system requirements in part 417 of this chapter, an establishment must develop and have on file, available to FSIS, a process schedule, as defined in § 381.1(b). Each process schedule must be approved in writing by a process authority for safety and efficacy in meeting the performance standards established for the product in question. A process authority must have access to an establishment in order to evaluate and approve the safety and efficacy of each process schedule. (d) Under the auspices of a processing authority, an establishment must validate new or altered process schedules by scientifically supportable means, such as information gleaned from the literature or by challenge studies conducted outside the plant." 9:9:2.0.2.1.35.15.40.5,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,O,Subpart O—Entry of Articles Into Official Establishments; Processing Inspection and Other Reinspections; Processing Requirements,,§ 381.151 Adulteration of product by polluted water; procedure for handling.,FSIS,,,"[38 FR 34456, Dec. 14, 1973]","(a) In the event there is polluted water (including but not limited to flood water) in an official establishment, all poultry products and ingredients for use in the preparation of such products that have been rendered adulterated by the water shall be condemned. (b) After the polluted water has receded from an official establishment, 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 establishment personnel. An adequate supply of hot water under pressure is essential to make such cleaning effective. After cleaning a solution of sodium hypochlorite containing approximately one-half of 1 percent available chlorine (5,000 p/m) or other equivalent disinfectant approved by the Administrator 1 shall be applied to the surface of the rooms and equipment and rinsed with potable water before use. 1 A list of approved disinfectants is available upon request to Scientific Services, Meat and Poultry Inspection Program, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250. (c) Hermetically sealed containers of poultry product which have been contaminated by polluted water shall be examined promptly by the official establishment under supervision of an inspector and rehandled as follows: (1) Separate and condemn all poultry products in damaged or extensively rusted containers. (2) Remove paper labels and wash the remaining containers in warm soapy water, using a brush where necessary to remove rust or other foreign material. Disinfect these containers by either of the following methods: (i) Immerse in a solution of sodium hypochlorite containing not less than 100 p/m of available chlorine or other equivalent disinfectant approved by the Administrator, 1 rinse in potable water, and dry thoroughly; or (ii) Immerse in 212 °F. water, bring temperature of the water back to 212 °F. and maintain the temperature at 212 °F. for 5 minutes, then remove containers from water and cool them to 95 °F. and dry thoroughly. (3) After handling as described in paragraph (c)(2) of this section, the containers may be relacquered, if necessary, and then relabeled with approved labels applicable to the product therein. (4) The identity of the canned poultry product shall be maintained throughout all stages of the rehandling operations, to insure correct labeling of containers." 9:9:2.0.2.1.35.15.40.6,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,O,Subpart O—Entry of Articles Into Official Establishments; Processing Inspection and Other Reinspections; Processing Requirements,,"§ 381.152 Manufacture of uninspected, inedible products at official establishments.",FSIS,,,"[84 FR 40227, Aug. 14, 2019]","(a) Official establishments may manufacture pet food or similar uninspected, inedible products in areas where edible products also are produced, provided that the manufacture of uninspected, inedible products does not: (1) Adulterate edible products; (2) Create insanitary conditions in the official establishment whereby edible products may be adulterated; or (3) Prevent or interfere with inspection or other program tasks performed by FSIS personnel in the official establishment. (b) The immediate container of uninspected, inedible products manufactured in an official establishment shall be conspicuously labeled so as to distinguish them from human food in accordance with § 381.193 of this subchapter." 9:9:2.0.2.1.35.15.40.7,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,O,Subpart O—Entry of Articles Into Official Establishments; Processing Inspection and Other Reinspections; Processing Requirements,,§ 381.153 [Reserved],FSIS,,,, 9:9:2.0.2.1.35.16.40.1,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,P,Subpart P—Definitions and Standards of Identity or Composition,,§ 381.155 General.,FSIS,,,"[37 FR 9706, May 16, 1972, as amended at 68 FR 22578, Apr. 29, 2003]","(a) Authorization to establish specifications. (1) The Administrator is authorized to establish specifications or definitions and standards of identity or composition, covering the principal constituents of any poultry product with respect to which a specified name of the product or other labeling terminology may be used, whenever he determines such action is necessary to prevent sale of the product under false or misleading labeling. Further, the Administrator is authorized to prescribe definitions and standards of identity or composition for poultry products whenever he determines such action is otherwise necessary for the protection of the public. The requirements of this subpart are hereby found to be necessary for these purposes and standards are hereby established as set forth in this subpart. (2) Where cooked poultry meat is specified in this subpart as an ingredient of poultry products, this means poultry meat derived from poultry processed, cooked, and cooled in a manner approved by the Administrator in specific cases without use of liquid or moisture in direct contact with the poultry meat following the cooking and cooling of the poultry. (3) If, following cooking and cooling of poultry meat to be used in poultry products, liquid or moisture is used in direct contact with such poultry meat and the percentage of solids, excluding salt, in the poultry meat is found to be below 34 percent when such poultry meat is tested by acceptable methods, the percentage of poultry meat required by this section for any poultry product shall be increased in proportion to the deficiency, or the meat shall be so processed as to raise the solids content, excluding salt, to 34 percent. The official establishment shall furnish adequate facilities for such testing. (b) Any binder or antimicrobial agent that has been found to be safe and suitable by the Food and Drug Administration and the Food Safety and Inspection Service may be used in the production of poultry products with standards of identity in this part, where the product standards and applicable Federal regulations already permit the use of these types of ingredients." 9:9:2.0.2.1.35.16.40.10,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,P,Subpart P—Definitions and Standards of Identity or Composition,,§ 381.164 “(Kind) barbecued.”,FSIS,,,,"Such product consists of ready-to-cook poultry of the kind indicated, that has been cooked in dry heat and basted with a seasoned sauce." 9:9:2.0.2.1.35.16.40.11,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,P,Subpart P—Definitions and Standards of Identity or Composition,,§ 381.165 “(Kind) barbecued prepared with moist heat.”,FSIS,,,,Such product consists of ready-to-cook poultry of the kind indicated that has been cooked by the action of moist heat in a barbecue sauce. 9:9:2.0.2.1.35.16.40.12,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,P,Subpart P—Definitions and Standards of Identity or Composition,,§ 381.166 Breaded products.,FSIS,,,,“Breaded” is a term applicable to any poultry product which is coated with breading or a batter and breading in an amount not to exceed 30 percent of the weight of the finished breaded product. 9:9:2.0.2.1.35.16.40.13,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,P,Subpart P—Definitions and Standards of Identity or Composition,,§ 381.167 Other poultry dishes and specialty items.,FSIS,,,"[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974]","Poultry dishes and specialty items listed in Table IV of this paragraph shall meet the requirements set forth in said table, irrespective of the type of packaging, and the percentages in Table IV shall be calculated on a ready-to-serve basis, except that soup bases in institutional packs which are prepared for sale to institutional users shall have a minimum of 15 percent cooked deboned poultry meat based on the weight of the soup base product. Table IV 1 The product name may contain other appropriate descriptive terms such as “noodle”; e.g., “Chicken Noodle Soup.” 2 This standard also applies to products named (Kind) with rice or similar starches. 3 The 25 percent-standard listed includes poultry meat plus proportions of skin and fat natural to the poultry used." 9:9:2.0.2.1.35.16.40.14,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,P,Subpart P—Definitions and Standards of Identity or Composition,,§ 381.168 Maximum percent of skin in certain poultry products.,FSIS,,,,"The poultry products listed in Table V shall have not more than the percent of skin specified in the table, when raw and when cooked. Table V" 9:9:2.0.2.1.35.16.40.15,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,P,Subpart P—Definitions and Standards of Identity or Composition,,§ 381.169 [Reserved],FSIS,,,, 9:9:2.0.2.1.35.16.40.16,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,P,Subpart P—Definitions and Standards of Identity or Composition,,"§ 381.170 Standards for kinds and classes, and for cuts of raw poultry.",FSIS,,,"[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 63 FR 48960, Sept. 11, 1998; 76 FR 68064, Nov. 3, 2011; 81 FR 21709, Apr. 13, 2016]","(a) The following standards specify the various classes of the specified kinds of poultry and the requirements for each class: (1) Chickens —(i) Rock Cornish game hen or Cornish game hen. A “Rock Cornish game hen” or “Cornish game hen” is a young, immature chicken (less than 5 weeks of age), of either sex, with a ready-to-cook carcass weight of not more than 2 pounds. (ii) Broiler or fryer. A “broiler” or “fryer” is a young chicken (less than 10 weeks of age), of either sex, that is tender-meated with soft, pliable, smooth-textured skin and flexible breastbone cartilage. (iii) Roaster or roasting chicken. A “roaster” or “roasting chicken” is a young chicken (less than 12 weeks of age), of either sex, with a ready-to-cook carcass weight of 5.5 pounds or more, that is tender-meated with soft, pliable, smooth-textured skin and breastbone cartilage that is somewhat less flexible than that of a broiler or fryer. (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. (v) Hen, fowl, baking chicken, or stewing chicken. A “hen,” “fowl,” “baking chicken,” or “stewing chicken” is an adult female chicken (more than 10 months of age) with meat less tender than that of a roaster or roasting chicken and a nonflexible breastbone tip. (vi) Cock or rooster. A “cock” or “rooster” is an adult male chicken with coarse skin, toughened and darkened meat, and a nonflexible breastbone tip. (2) Turkeys —(i) Fryer-roaster turkey. A “fryer-roaster turkey” is an immature turkey (less than 12 weeks of age), of either sex, that is tender-meated with soft, pliable, smooth-textured skin, and flexible breastbone cartilage. (ii) Young turkey. A “young turkey” is a turkey (less than 8 months of age), of either sex, that is tender-meated with soft, pliable, smooth-textured skin and breastbone cartilage that is less flexible than that of a fryer-roaster turkey. (iii) Yearling turkey. A “yearling turkey” is a turkey (less than 15 months of age), of either sex, that is reasonably tender-meated with reasonably smooth-textured skin. (iv) Mature or old (hen or tom) turkey. A “mature turkey” or “old turkey” is an adult turkey (more than 15 months of age), of either sex, with coarse skin and toughened flesh. Sex designation is optional. (3) Ducks —(i) Duckling. A “duckling” is a young duck (less than 8 weeks of age), of either sex, that is tender-meated and has a soft bill and soft windpipe. (ii) Roaster duck. A “roaster duck” is a young duck (less than 16 weeks of age), of either sex, that is tender-meated and has a bill that is not completely hardened and a windpipe that is easily dented. (iii) Mature duck or old duck. A “mature duck” or an “old duck” is an adult duck (more than 6 months of age), of either sex, with toughened flesh, a hardened bill, and a hardened windpipe. (4) Geese —(i) Young goose. A “young goose” is an immature goose, of either sex, that is tender-meated and has a windpipe that is easily dented. (ii) Mature goose or old goose. A “mature goose” or “old goose” is an adult goose, of either sex, that has toughened flesh and a hardened windpipe. (5) Guineas —(i) Young guinea. A “young guinea” is an immature guinea, of either sex, that is tender-meated and has a flexible breastbone cartilage. (ii) Mature guinea or old guinea. A “mature guinea” or “old guinea” is an adult guinea, of either sex, that has toughened flesh and a non-flexible breastbone. (b) The following standards specify the requirements for the specified cuts of poultry: (1) “Breasts” shall be separated from the back at the shoulder joint and by a cut running backward and downward from that point along the junction of the vertebral and sternal ribs. The ribs may be removed from the breasts, and the breasts may be cut along the breastbone to make two approximately equal halves; or the wishbone portion, as described in paragraph (b)(3) of this section, may be removed before cutting the remainder along the breastbone to make three parts. Pieces cut in this manner may be substituted for lighter or heavier pieces for exact weight-making purposes and the package may contain two or more of such parts without affecting the appropriateness of the labeling as e.g., “chicken breasts.” Neck skin shall not be included with the breasts, except that “turkey breasts” may include neck skin up to the whisker. (2) “Breasts with ribs” shall be separated from the back at the junction of the vertebral ribs and back. Breasts with ribs may be cut along the breastbone to make two approximately equal halves; or the wishbone portion, as described in paragraph (b)(3) of this section, may be removed before cutting the remainder along the breastbone to make three parts. Pieces cut in this manner may be substituted for lighter or heavier pieces for exact weight-making purposes and the package may contain two or more of such parts without affecting the appropriateness of the labeling as “breasts with ribs.” Neck skin shall not be included, except that “turkey breasts with ribs” may include neck skin up to the whisker. (3) “Wishbones” (Pulley Bones), with covering muscle and skin tissue, shall be severed from the breast approximately halfway between the end of the wishbone (hypocledium) and front point of the breastbone (cranial process of the sternal crest) to a point where the wishbone joins the shoulder. Neck skin shall not be included with the wishbone. (4) “Drumsticks” shall be separated from the thigh by a cut through the knee joint (femorotibial and patellar joint) and from the hock joint (tarsal joint). (5) “Thighs” shall be disjointed at the hip joint and may include the pelvic meat, but shall not include the pelvic bones. Back skin shall not be included. (6) “(Kind) legs” shall be the poultry product which includes the thigh and the drumstick, i.e., the whole leg, and may include the pelvic meat, but shall not include the pelvic bones. Back skin shall not be included. (7) “Wings” shall include the entire wing with all muscle and skin tissue intact, except that the wingtip may be removed. (8) “Backs” shall include the pelvic bones and all the vertebrae posterior to the shoulder joint. The meat shall not be peeled from the pelvic bones. The vertebral ribs and/or scapula may be removed or included without affecting the appropriateness of the name. Skin shall be substantially intact. (9) “Stripped backs” shall include the vertebrae from the shoulder joint to the tail, and include the pelvic bones. The meat may be stripped off of the pelvic bones. (10) “Necks”, with or without neck skin, shall be separated from the carcass at the shoulder joint. (11) “Halves” are prepared by making a full-length back and breast split of an eviscerated poultry carcass so as to produce approximately equal right and left sides. (12) “Quarters” consist of the entire eviscerated poultry carcass, which has been cut into four equal parts, but excluding the neck. (13) “Breast quarter” consists of half a breast with the wing and a portion of the back attached. (14) “Breast quarter without wing” consists of a front quarter of a poultry carcass, from which the wing has been removed. (15) “Leg quarter” consists of a poultry thigh and drumstick, with a portion of the back attached. (16) “Thigh with back portion” consists of a poultry thigh with back portion attached. (17) “Legs with pelvic bone” consists of a poultry leg with adhering meat and skin and pelvic bone. (18) “Wing drummette” consists of the humerus of a poultry wing with adhering skin and meat attached. (19) “Wing portion” consists of a poultry wing except that the drummette has been removed. (20) “Cut-up Poultry” is any cut-up or disjointed portion of poultry or any edible part thereof, as described in this section. (21) “Giblets” consist of approximately equal numbers of hearts, gizzards, and livers, as determined on a count basis. (22) “Major portions” of eviscerated poultry carcasses are either carcasses from which parts may be missing, or the front or rear portions of transversely-split carcasses." 9:9:2.0.2.1.35.16.40.17,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,P,Subpart P—Definitions and Standards of Identity or Composition,,§ 381.171 Definition and standard for “Turkey Ham.”,FSIS,,,"[44 FR 51190, Aug. 31, 1979; 64 FR 72175, Dec. 23, 1999]","(a) “Turkey Ham” shall be fabricated from boneless, turkey thigh meat with skin and the surface fat attached to the skin removed. The thighs shall be that cut of poultry described in § 381.170(b)(5) of this part. (b) The product may or may not be smoked, and shall be cured using one or more of the approved curing agents as provided in a regulation permitting that use in this subchapter or 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B. The product may also contain cure accelerators, phosphates, and flavoring agents as provided in a regulation permitting that use in this subchapter or 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B; common salt, sugars, spices, spice extractives, dehydrated garlic, and dehydrated onions; and water for purpose of dissolving and dispersing the substances specified above. (c) The cooked finished product weight shall be no more than the original weight of the turkey thigh meat used prior to curing. (d) The product name on the label shall show the word “Turkey” in the same size, style, color, and with the same background as the word “Ham” and shall precede and be adjacent to it. (e) The product name shall be qualified with the statement “Cured Turkey Thigh Meat.” The qualifying statement shall be contiguous to the product name, without intervening type or designs, shall be not less than one-half the size of the product name but not less than one-eighth inch in height, and shall be in the same style and color and with the same background as the product name. (f) If the product is fabricated from pieces of turkey thigh meat that result from the cutting through the muscle (as opposed the whole thighs intact or whole thighs with some incidental separation of muscle tissue during removal of the bone), the product name shall be further qualified by a descriptive statement. The product name of product fabricated from such pieces of turkey thigh meat equivalent in size to a one-half inch cube or greater shall be further qualified to specify that the product is “Chunked and Formed.” The product name of product fabricated from such pieces of turkey thigh meat smaller than the equivalent of a one-half inch cube shall be further qualified to specify that the product is “Ground and Formed” or “Chopped and Formed” as appropriate. The qualifying statement shall immediately follow and be contiguous to the statement required in paragraph (e) of this section, and shall be not less than one-half the size of the product name but not less than one-eighth inch in height, and shall be in the same style and color and with the same background as the product name." 9:9:2.0.2.1.35.16.40.18,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,P,Subpart P—Definitions and Standards of Identity or Composition,,§ 381.172 Requirements for substitute standardized poultry products named by use of an expressed nutrient content claim and a standardized term.,FSIS,,,"[70 FR 33818, June 10, 2005]","(a) Description. The poultry products prescribed by this general definition and standard of identity are those products that substitute, in accordance with § 381.413(d), for a standardized product defined in this subpart and use the name of that standardized product in their statements of identity, but that do not comply with the established standard because of a compositional deviation that results from reduction of a constituent that is described by an expressed nutrient content claim that has been defined by regulation in this subpart. The expressed nutrient content claim shall comply with the requirements of § 381.413 and with the requirements in subpart Y of this part which define the particular nutrient content claim that is used. The poultry product shall comply with the relevant standard in this part in all other respects, except as provided in paragraphs (b) and (c) of this section. (b) Performance characteristics. The performance characteristics, such as physical properties, functional properties, and shelf-life, of the poultry product shall be similar to those of the standardized poultry product produced under subpart P of this part. If there is a significant difference in a performance characteristic that materially limits the use of the product compared to the use of the standardized product defined in subpart P of this part, the label shall include a statement in accordance with § 381.413(d)(1) and (2) of this part, that informs the consumer of such differences ( e.g. , if appropriate, “not recommended for frozen storage” or “not suitable for roller grilling”). Deviations from the ingredient provisions of the standard must be the minimum necessary to qualify for the nutrient content claim, while maintaining similar performance characteristics. (c) Ingredients used in substitute products. (1) Ingredients used in the product shall be those ingredients provided for in the standard as defined in subpart P of this part, except that safe and suitable ingredients permitted for use in poultry products as provided in a regulation permitting that use in this subchapter or in 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B, may be used at the minimum level necessary to improve texture and prevent syneresis, so that the substitute product is not inferior in performance characteristics from the standardized product defined in subpart P of this part for which it is a substitute. (2) An ingredient that is specifically required by the standard prescribed in subpart P of this part shall not be replaced or exchanged with a similar ingredient from another source, for example, extruded turnips shall not replace noodles in poultry with noodles. (3) An ingredient that is specifically prohibited from use in any poultry product by subpart P of this part shall not be added to the substitute poultry product under this section. (4) Unless otherwise specified in this part, a substitute poultry product must meet all other requirements of the applicable standards of identity or composition. (5) Water and fat-replacers ( e.g. , binders), in combination, may be added to replace fat in accordance with paragraph (c) of this section. (6) Textured vegetable protein may be used by itself or in combination with other binders and water as a fat replacer in accordance with paragraph (c) of this section. (d) Nomenclature. The name of a substitute poultry product that complies with this section is the appropriate expressed nutrient content claim and the applicable standardized term. (e) Label declaration. (1) Each of the ingredients used in the substitute poultry product shall be declared on the label as required by this section and subpart N of this part. (2) Ingredients not provided for, and ingredients used in excess of those levels provided for, by the standard as defined in subpart P of this part, shall be identified as such with an asterisk in the ingredients statement. The statement “*Ingredients not in regular __________” (the blank shall be filled in with the name of the traditional standardized product) or “**Ingredients in excess of amounts permitted in regular __________” (the blank shall be filled in with the name of the traditional standardized product), or both, as appropriate, shall immediately follow the ingredients statement in the same type and size." 9:9:2.0.2.1.35.16.40.19,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,P,Subpart P—Definitions and Standards of Identity or Composition,,§ 381.173 Mechanically Separated (Kind of Poultry).,FSIS,,,"[60 FR 55983, Nov. 3, 1995]","(a) “Mechanically Separated (Kind of Poultry)” is any product resulting from the mechanical separation and removal of most of the bone from attached skeletal muscle and other tissue of poultry carcasses and parts of carcasses that has a paste-like form and consistency, that may or may not contain skin with attached fat and meeting the other provisions of this section. Examples of such product are “Mechanically Separated Chicken” and “Mechanically Separated Turkey.” (b) “Mechanically Separated (Kind of Poultry)” shall not have a bone solids content of more than 1 percent. At least 98 percent of the bone particles present in “Mechanically Separated (Kind of Poultry) “ shall have a maximum size no greater than 1.5 mm (millimeter) in their greatest dimension and there shall be no bone particles larger than 2.0 mm in their greatest dimension. (c) “Mechanically Separated (Kind of Poultry)” shall not have a calcium content exceeding 0.235 percent when made from mature chickens or from turkeys as defined in § 381.170(a)(l)(vi) and (vii) and (a)(2), respectively, or 0.175 percent when made from other poultry, based on the weight of product that has not been heat treated, as a measure of a bone solids content of not more than 1 percent. (d) “Mechanically Separated (Kind of Poultry)” may be used in the formulation of poultry products in accordance with § 381.174 and meat food products in accordance with subchapter A of this chapter. (e) Product resulting from the mechanical separation process that fails to meet the bone particle size or calcium content requirements for “Mechanically Separated (Kind of Poultry)” shall be used only in producing poultry extractives, including fats, stocks, and broths and labeled as “Mechanically Separated (Kind of Poultry) for Further Processing.”" 9:9:2.0.2.1.35.16.40.2,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,P,Subpart P—Definitions and Standards of Identity or Composition,,§ 381.156 Poultry meat content standards for certain poultry products.,FSIS,,,"[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974]","Poultry products with labeling terminology as set forth in Table I shall comply with the specifications for percent light meat and percent dark meat set forth in said table. Table I" 9:9:2.0.2.1.35.16.40.20,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,P,Subpart P—Definitions and Standards of Identity or Composition,,§ 381.174 Limitations with respect to use of Mechanically Separated (Kind of Poultry).,FSIS,,,"[60 FR 55983, Nov. 3, 1995]","(a) A poultry product required to be prepared from a particular kind of poultry (e.g., chicken) shall not contain “Mechanically Separated (Kind of Poultry)” described in § 381.173, that is made from any other kind of poultry (e.g., Mechanically Separated Turkey). (b) “Mechanically Separated (Kind of Poultry)” described in § 381.173 may be used in the formulation of any poultry or meat food product, provided such use conforms with any applicable requirements of the definitions and standards of identity or composition in this subchapter or part 319 of this chapter, and provided that it is identified as “Mechanically Separated (Kind of Poultry).”" 9:9:2.0.2.1.35.16.40.3,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,P,Subpart P—Definitions and Standards of Identity or Composition,,§ 381.157 Canned boned poultry and baby or geriatric food.,FSIS,,,"[37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974]","(a) Canned boned poultry shall, unless otherwise specified in this section, be prepared from cooked deboned poultry meat and may contain skin and fat not in excess of natural whole carcass proportions. Gelatin, stabilizers, or similar solidifying or emulsifying agents shall not be added to product labeled “Boned (Kind)—Solid Pack,” but may be added in quantities not in excess of a total of 0.5 percent of the total ingredients in the preparation of other canned boned poultry products and in such cases the common name of the substance shall be included in the name of the product, e.g., “Boned Chicken with Broth—Gelatin Added.” (b) Canned boned poultry, except poultry within paragraph (c) of this section, shall meet the requirements set forth in Table II. The percentages in Table II shall be calculated on the basis of the total ingredients used in the preparation of the product. (c) Canned boned poultry with natural juices (Boned (Kind) with natural juices) shall be prepared from either raw boned poultry or a mixture of raw boned poultry and cooked boned poultry and shall have no liquid added during the preparation of the product. (d) Canned shredded poultry (Shredded Kind), consists of poultry meat reduced to a shredded appearance, from the kind of poultry indicated, with meat, skin, and fat not in excess of the natural whole carcass proportions. Canned shredded poultry from specific parts may include skin or fat in excess of the proportions normally found on a whole carcass, but not in excess of the proportions of skin and fat normal to the particular part or parts; and such product shall be labeled in accordance with § 381.117(d). (e) Canned boned poultry shall be prepared as set forth in Table II, items 1, 2, 3, or 4, whichever is applicable. Table II 1 Liquid may be in the form of, but is not limited to, broth or extractives. 2 Alternatively, product may be prepared from raw boned poultry in combination with cooked boned poultry so long as the product complies with the specified standard. 3 Total amount of liquid added shall be included in the name of the product; e.g., “Boned Chicken with 25 percent broth.” (f) Poultry products intended for infant or geriatric use and represented as having a “high meat” content shall contain not less than 18.75 percent cooked, deboned poultry meat of the kind indicated, with seasoning. Table IIa 1 Liquid may be in the form of, but not limited to, broth or extractives. 2 Alternatively, product may be prepared from raw boned poultry meat in combination with cooked bone poultry meat so long as the product complies with the specified standard. 3 Label must indicate in some manner that product is for infant or geriatric servings." 9:9:2.0.2.1.35.16.40.4,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,P,Subpart P—Definitions and Standards of Identity or Composition,,§ 381.158 Poultry dinners (frozen) and pies.,FSIS,,,,"Poultry dinners (frozen) and pies shall meet the requirements set forth in Table III of this section and the percentage or weight specified therein shall be calculated on the basis of total ingredients used in the preparation of the poultry product. Table III 1 14 percent or 1 1/8 oz., whichever is greater; or 25 percent or 2 oz., whichever is greater. 2 Excluding weight of appetizers, desserts, etc. 3 18 percent or 2 oz., whichever is greater. A minimum of 45 percent, or 5 ounces per dinner, whichever is greater, of cooked poultry including bone and breading may be used in lieu of minimum 18 percent or 2 ounces of cooked deboned poultry meat and the cooked poultry including bone and breading shall not contain more than 30 percent breading." 9:9:2.0.2.1.35.16.40.5,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,P,Subpart P—Definitions and Standards of Identity or Composition,,§ 381.159 Poultry rolls.,FSIS,,,"[37 FR 9706, May 16, 1972, as amended at 55 FR 34684, Aug. 24, 1990; 66 FR 54916, Oct. 31, 2001]","(a) Binders or extenders may be added in accordance with a regulation in this subchapter, in 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B. In addition to the binders referred to in the preceding sentence, the following substances are permitted for use as binders in poultry rolls: transglutaminase enzyme at up to 65 ppm. When binding agents are added in excess of 3 percent for cooked rolls and 2 percent for raw rolls, the common name of the agent or the term “Binders Added” shall be included in the name of the product; e.g., “Turkey Roll-Gelatin Added.” (b) With respect to heat processed rolls, 2 percent or less liquid based on the weight of the finished product without liquid may remain with or be returned to product labeled as “(Kind) Roll.” (c) Heat processed rolls which have more than 2 percent liquid remaining with or returned to the product shall be labeled as “(Kind) Roll with Natural Juices.” If more than 2 percent of any liquid other than natural cookout juices is added, the product must be labeled to indicate that fact; e.g., “Turkey Roll with Broth.” Liquid shall not be returned or added to product within this paragraph graph in excess of the amount normally cooked out during preparation." 9:9:2.0.2.1.35.16.40.6,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,P,Subpart P—Definitions and Standards of Identity or Composition,,§ 381.160 (Kind) burgers; (Kind) patties.,FSIS,,,,"Such product consists of 100 percent poultry of the kind indicated, with skin and fat not in excess of natural proportions. Product containing fillers or binders shall be named “(Kind) Patties.”" 9:9:2.0.2.1.35.16.40.7,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,P,Subpart P—Definitions and Standards of Identity or Composition,,§ 381.161 “(Kind) A La Kiev.”,FSIS,,,,"Such product consists of poultry meat of the kind indicated, stuffed with butter which may be seasoned and the product may be wrapped in sufficient skin to cover the meat. It may be dipped in batter, fried, and frozen." 9:9:2.0.2.1.35.16.40.8,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,P,Subpart P—Definitions and Standards of Identity or Composition,,§ 381.162 “(Kind) steak or fillet.”,FSIS,,,,Such product consists of a boneless slice or strip of poultry meat of the kind indicated. 9:9:2.0.2.1.35.16.40.9,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,P,Subpart P—Definitions and Standards of Identity or Composition,,§ 381.163 “(Kind) baked” or “(Kind) roasted.”,FSIS,,,,"Such product consists of ready-to-cook poultry of the kind indicated, that has been cooked in dry source heat, e.g., oven roasted or oven baked." 9:9:2.0.2.1.35.17.40.1,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,Q,"Subpart Q—Records, Registration, and Reports",,§ 381.175 Records required to be kept.,FSIS,,,"[37 FR 9706, May 16, 1972, as amended at 47 FR 746, Jan. 7, 1982; 49 FR 2236, Jan. 19, 1984; 51 FR 45633, Dec. 19, 1986; 57 FR 43600, Sept. 21, 1992; 58 FR 675, Jan. 6, 1993; 60 FR 67458, Dec. 29, 1995; 78 FR 66838, Nov. 7, 2013; 83 FR 25308, May 31, 2018]","(a) Every person within any of the classes specified in paragraph (a) (1), (2), or (3) of this section is required by the Act to keep such records as are properly necessary for the effective enforcement of the Act: (1) Any person that engages in the business of slaughtering any poultry or processing, freezing, packaging, or labeling any carcasses, or parts or products of carcasses, of any poultry, for commerce, for use as human food or animal food; (2) Any person that engages in the business of buying or selling (as a poultry products broker, wholesaler, or otherwise) or transporting, in commerce, or storing in or for commerce, or importing, any carcasses, or parts or products of carcasses, of any poultry; (3) Any person that engages in business, in or for commerce, as a renderer, or engages in the business of buying, selling, or transporting in commerce, or importing, any dead, dying, disabled, or diseased poultry or parts of the carcasses of any poultry that died otherwise than by slaughter. (b) The required records are: (1) Records, such as bills of sale, invoices, bills of lading, and receiving and shipping papers, giving the following information with respect to each transaction in which any poultry or poultry carcass, or part or product of a poultry carcass, is purchased, sold, shipped, received, transported, or otherwise handled by said person in connection with any business subject to the Act. (i) The name or description of the poultry or other articles; (ii) The net weight of the poultry or other articles; (iii) The number of outside containers; (iv) The name and address of the buyer of the poultry or other articles sold by such person, and the name and address of the seller of the poultry or other articles purchased by such person; (v) The name and address of the consignee or receiver (if other than the buyer); (vi) The method of shipment; (vii) The date of shipment; and (viii) The name and address of the carrier. (2) Guaranties provided by suppliers of packaging materials under § 381.144. (3) Records of canning as required by part 431 of this chapter. (4) Records of irradiation as required by sections 381.149 of this part. (5) Records of nutrition labeling as required by subpart Y of this part. (6) Records of all labeling, along with the product formula, processing procedures, and any additional documentation needed to support that the labels are consistent with the Federal meat and poultry regulations and policies on labeling, as prescribed in § 412.1 of this chapter." 9:9:2.0.2.1.35.17.40.2,9,Animals and Animal Products,III,A,381,PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS,Q,"Subpart Q—Records, Registration, and Reports",,§ 381.176 Place of maintenance of records.,FSIS,,,,"Every person engaged in any business described in § 381.175(a) shall maintain the records required by § 381.175 at the place of business where such business is conducted, except that, if such person conducts such business at multiple locations, he may maintain such records at his headquarters' office. When not in actual use, all such records shall be kept in a safe place at the prescribed location in accordance with good commercial practices."