POULTRY PRODUCTS INSPECTION REGULATIONS

• Citation: 9 CFR Part 381
• Sections: 203

§ 381.1 Definitions.

(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,

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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.

§ 381.3 Administration.

(a) [Reserved]

(b) The Administrator may in specific classes of cases waive for limited periods any provisions of the regulations in order to permit appropriate and necessary action in the event of a public health emergency or to permit experimentation so that new procedures, equipment, and processing techniques may be tested to facilitate definite improvements: Provided, That such waivers of the provisions of the regulations are not in conflict with the purposes or provisions of the Act.

(c) Pursuant to section 6 of the Act, the Administrator believes that, in establishments processing poultry products at which inspection under the Act and regulations is required, the frequency with which and the manner in which poultry products made from poultry previously slaughtered and eviscerated in official establishments are reinspected by Inspection Service employees should be based on considerations relevant to effective regulation of poultry products and protection of the health and welfare of consumers. In order to test procedures for use in making such determinations and, in particular, for determining whether and, if so, to what extent the intensity of inspection coverage exceeds that which should be deemed necessary pursuant to section 6 of the Act, the Administrator is initiating experimentation of a new system of inspection for reviewing the performance of establishments and for designing the supervision and other conditions and methods of inspection coverage. For the period of such experimentation, the Administrator shall identify establishments for review, and the frequency and the manner of inspection by Inspection Service employees shall be determined on the basis of the results of those reviews and be otherwise in accordance with this section.

(d) The determinations referred to in paragraph (c) of this section shall be made by the Inspection Service and shall reflect evaluations of the performance and the characteristics of such establishments.

(1) In assessing the performance of an establishment, the following factors are appropriate for consideration:

(i) The history of compliance with applicable regulatory requirements by the person operating such establishment or by anyone responsibly connected with the business operating such establishment, as “responsibly connected” is defined in section 18(a) of the Act,

(ii) The competence of the person operating such establishment, as indicated by:

(A) Knowledge of appropriate manufacturing practices and applicable regulatory requirements,

(B) Demonstrated ability to apply such knowledge in a timely and consistent manner, and

(C) Commitment to correcting deficiencies noted by Inspection Service employees and otherwise assuring compliance with applicable regulatory requirements, and

(iii) The procedures used in such establishment to control the production process, environment, and resulting product in order to assure and monitor compliance with the requirements of the Act and the rules and regulations promulgated thereunder.

(2) In assessing the characteristics of an establishment, the following factors are appropriate for consideration:

(i) The complexity of the processing operation(s) conducted at such establishment,

(ii) The frequency with which each such operation is conducted at such establishment,

(iii) The volume of product resulting from each such operation at such establishment,

(iv) Whether and to what extent slaughter and evisceration operations also are conducted at such establishment,

(v) What, if any, food products not regulated under this Act or the Federal Meat Inspection Act also are processed at such establishment, and

(vi) The size of such establishment.

(e)(1) For the period of experimentation described in paragraph (c) of this section, the frequency of inspection by Inspection Service employees of operations other than slaughter and evisceration may be reduced in an establishment in which the procedures referred to therein are being tested if and only if the evaluation of the performance of such establishment described in paragraph (d)(1) indicates that there are:

(i) No instances, documented in records compiled no earlier than 10 years before, of substantial and recent noncompliance with applicable regulatory requirements (taking into account both the nature and frequency of any such noncompliance), and

(ii) The competence and control procedures needed to assure and monitor compliance with applicable regulatory requirements.

(2)(i) The frequency of Federal inspection and other conditions and methods of inspection coverage in any establishment in which the frequency of Federal inspection is reduced shall be based on:

(A) The evaluation of the characteristics of such establishment described in paragraph (d)(2) of this section,

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1 These evaluations will be based upon guidelines developed by FSIS and the complexity categorization in FSIS Directive 1030.2 (Documentation of Processing and Combination Assignments, 4/22/85). The guidelines and Directive will be available for public inspection and copying in the Policy Office, Room 3168, South Agriculture Building, 14th Street and Independence Avenue, SW., Washington, DC.

(B) The significance of potential public health consequences of noncompliance, and

(C) The availability of Inspection Service employees.

(ii) To the extent that frequency of inspection or other conditions and methods of inspection coverage are identified as conflicting with provisions of the regulations in this part, the Administrator will waive such provisions for the period of experimentation, in accordance with paragraph (b) of this section.

§ 381.4 Inspection in accordance with methods prescribed or approved.

Inspection of poultry products shall be rendered pursuant to the regulations and under such conditions and in accordance with such methods as may be prescribed or approved by the Administrator.

§ 381.5 Publications.

Publications under the Act and the regulations shall be made in the Federal Register and in such other media as the Administrator may designate.

§ 381.6 Establishments requiring inspection.

Inspection under the regulations is required at:

(a) Every establishment, except as provided in § 381.10 (a) and (b) or § 381.11, in which any poultry is slaughtered for transportation or sale in commerce, or in which any poultry products are wholly or in part, processed for transportation or sale in commerce, as articles intended for use as human food;

(b) Every establishment, except as provided in § 381.10 (a) and (b), (c), or (d), or § 381.11, within any State or organized territory which is designated pursuant to section 5(c) of the Act, at which any poultry is slaughtered or any poultry products are processed, for use as human food solely for distribution within such jurisdiction; and

(c) Except as provided in § 381.10 (a) and (b), or (c), or § 381.11, every establishment designated by the Administrator pursuant to section 5(c) of the Act as one producing adulterated poultry products which would clearly endanger the public health.

§ 381.7 Coverage of all poultry and poultry products processed in official establishments.

All poultry and poultry products processed in an official establishment shall be inspected, handled, processed, marked, and labeled as required by the regulations.

§ 381.10 Exemptions for specified operations.

(a) The requirements of the Act and the regulations for inspection of the processing of poultry and poultry products shall not apply to:

(1) Any retail dealer with respect to poultry products sold in commerce directly to consumers in an individual retail store, if the only processing operation performed by such retail dealer is the cutting up of poultry products on the premises where such sales to consumers are made: Provided, That such operation is conducted under such sanitary standards, practices, and procedures as result in the preparation of poultry products that are not adulterated: And provided further, That the poultry products sold in commerce are derived from poultry inspected and passed under the Act and such poultry products are not adulterated or misbranded at the time of sale (except that the official inspection legend shall not be used). (For the purposes of this subparagraph, a retail dealer is any person who sells poultry products directly to consumers as defined in paragraph (d)(2)(vi) of this section and whose sales of poultry products to household consumers constitute, in terms of dollar value, at least 75 percent of his total sales of poultry products.)

(2) The slaughter of poultry, and the processing of poultry products, by any person in any territory not organized with a legislative body, solely for distribution within such territory: Provided, That such poultry is sound and healthy and is slaughtered under such sanitary standards, practices, and procedures as result in the preparation of poultry products that are not adulterated: And provided further, That the poultry products are not adulterated or misbranded when so distributed (except that the official inspection legend shall not be used).

(3) The slaughtering by any person of poultry of his own raising, and the processing by him and transportation in commerce of the poultry products exclusively for use by him and members of his household and his nonpaying guests and employees: Provided, That in lieu of complying with all the adulteration and misbranding provisions of the Act, such poultry is healthy and is slaughtered and processed under such sanitary standards, practices, and procedures as result in the preparation of poultry products that are sound, clean, and fit for human food, and the shipping containers of such poultry products bear the producer's name and address and the statement “Exempted—P.L. 90-492.”

(4) The custom slaughter by any person of poultry delivered by the owner thereof for such slaughter, and the processing by such slaughterer and transportation in commerce of the poultry products exclusively for use, in the household of such owner, by him and members of his household and his nonpaying guests and the employees: Provided, That such custom slaughterer does not engage in the business of buying or selling any poultry products capable of use as human food: And provided further, That in lieu of complying with all the adulteration and misbranding provisions of the Act, such poultry is healthy and is slaughtered and processed under such sanitary standards, practices, and procedures as result in the preparation of poultry products that are sound, clean and fit for human food, and the shipping containers of such poultry products bear the owner's name and address and the statement “Exempted—P.L. 90-492.”

(5) The slaughtering of sound and healthy poultry and processing of poultry products therefrom in any State or territory or the District of Columbia by any poultry producer on his own premises with respect to poultry raised on his premises, and the distribution by any person solely within such jurisdiction of the poultry products derived from such operations: Provided, That (i) in lieu of complying with all the adulteration provisions of the Act, such poultry is slaughtered and otherwise processed and handled under such sanitary standards, practices, and procedures as result in the preparation of poultry products that are sound, clean, and fit for human food when so distributed; (ii) such poultry products when so distributed, bear (in lieu of labeling that would otherwise be required) the producer's name and address and the statement “Exempted—P.L. 90-492” and such poultry products are not otherwise misbranded; (iii) such producer and distributor do not engage in the current calendar year in the business of buying or selling any poultry or poultry products other than as specified in this paragraph (a) (5) or (6) of this section; and (iv) neither such producer or distributor slaughters or processes the products of more poultry than allowed by paragraph (b) of this section.

(6) The slaughtering of sound and healthy poultry or the processing of poultry products of such poultry in any State or territory or the District of Columbia by any poultry producer or other person for distribution by him solely within such jurisdiction directly to household consumers, restaurants, hotels, and boardinghouses, for use in their own dining rooms, or in the preparation of meals for sales direct to consumers: Provided, That (i) in lieu of complying with all the adulteration provisions of the Act, such poultry is slaughtered and otherwise processed and handled under such sanitary standards, practices, and procedures as result in the preparation of poultry products that are sound, clean, and fit for human food when distributed by such processor; (ii) such poultry products when so distributed bear (in lieu of labeling that would otherwise be required) the processor's name and address and the statement “Exempted—P.L. 90-492” and such poultry products are not otherwise misbranded; (iii) such processor does not engage in the current calendar year in the business of buying or selling any poultry or poultry products other than as specified in this paragraph (a) (6) or (5) of this section; and (iv) such processor does not exceed the volume limitation prescribed in paragraph (b) of this section.

(7) The operations and products of small enterprises (including poultry producers) not exempted under paragraphs (a) (1) through (6) of this section that are engaged in any State or territory or the District of Columbia in slaughtering and/or cutting up poultry for distribution as carcasses or parts thereof solely for distribution within such jurisdiction; Provided, That (i) such poultry is sound and healthy when slaughtered and is slaughtered and/or cut up and handled under such sanitary standards, practices and procedures as result in the preparation of poultry products that are not adulterated when so distributed; and (ii) when so distributed, such poultry products are not misbranded (except that the official inspection legend shall not be used).

(b) No person qualifies for any exemption specified in paragraph (a)(5), (6), or (7) of this section if, in the current calendar year, such person:

(1) Slaughters or processes the products of more than 20,000 poultry, or

(2) Slaughters or processes poultry products at a facility used for slaughtering or processing poultry products by any other person, except when the Administrator grants such exemption after determining, upon review of a person's application, that such an exemption will not impair effectuating the purposes of the Act.

(c) The provisions of the Act and the regulations do not apply to any poultry producer with respect to poultry, of his own raising on his own farm, which he slaughters if:

(1) Such producer slaughters not more than 1,000 poultry during the calendar year for which this exemption is being determined;

(2) Such poultry producer does not engage in buying or selling poultry products other than those produced from poultry raised on his own farm; and

(3) None of such poultry moves in “commerce” (as defined in § 381.1).

(d)(1) The requirements of the Act and the regulations for inspection of the processing of poultry and poultry products do not apply to operations of types traditionally and usually conducted at retail stores and restaurants, when conducted at any retail store or restaurant or similar-retail-type establishment for sale in normal retail quantities or service of such articles to consumers at such establishments.

(2) For the purposes of paragraph (d)(1) of this section:

(i) Operations of types traditionally and usually conducted at retail stores and restaurants include any processing of poultry products except canning of poultry products and except slaughtering of poultry unless such slaughtering is conducted at a retail store with respect to live poultry purchased by the consumer at the retail store and processed by the retail store operator in accordance with the consumer's instructions.

(ii) A normal retail quantity is any quantity of a poultry product purchased by a household consumer from a retail supplier that in the aggregate does not exceed 75 pounds. A normal retail quantity sold by a retail supplier to other than a household consumer is any quantity that in the aggregate does not exceed 150 pounds.

(iii) A retail store is any place of business where:

( a ) The sales of poultry products are made to consumers only;

( b ) At least 75 percent, in terms of dollar value, of total sales of product represents sales to household consumers and the total dollar value of sales of product to consumers other than household consumers does not exceed the dollar limitation per calendar year set by the Administrator. This dollar limitation is a figure which will automatically be adjusted during the first quarter of each calendar year, upward or downward, whenever the Consumer Price Index, published by the Bureau of Labor Statistics, Department of Labor, indicates a change in the price of this same volume of product which exceeds $500. Notice of the adjusted dollar limitation will be published in the Federal Register.

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1 The dollar limitation currently in effect may be obtained by contacting Director, Slaughter Inspection Standards and Procedures Division, Technical Services, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250 [phone].

( c ) Only federally or State inspected and passed, or exempted (or, as provided in § 381.223, State or local agency inspected and passed or exempted) poultry products are handled or used in the preparation of any poultry products;

( d ) No sale of poultry products is made in excess of a normal retail quantity as defined in paragraph (d)(2)(ii) of this section; and

( e ) The processing of poultry products for sale is limited to traditional and usual operations as defined in paragraph (d)(2)(i) of this section.

(iv) Restaurants. ( a ) A restaurant is any establishment where:

( 1 ) Poultry products are processed only for sale or service in meals or as entrees directly to individual consumers at such establishments;

( 2 ) Only federally inspected and passed, or exempted (or, as provided in § 381.223, State or local agency inspected and passed or exempted) poultry products are handled or used in the preparation of any poultry products;

( 3 ) No sale of poultry products is made in excess of a normal retail quantity as defined in paragraph (d)(2)(ii) of this section; and

( 4 ) The processing of poultry products is limited to traditional and usual operations as defined in paragraph (d)(2)(i) of this section.

( b ) The definition of a restaurant includes a caterer which delivers or serves product in meals, or as entrees, only to individual consumers and otherwise meets the requirements of this paragraph.

( c ) For purposes of this paragraph, operations conducted as a restaurant central kitchen facility shall be considered as being conducted at a restaurant if the restaurant central kitchen prepares poultry products that are ready to eat when they leave such facility (i.e., no further cooking or other preparation is needed, except that they may be reheated prior to serving if chilled during transportation), transported directly to a receiving restaurant by its own employees, without intervening transfer or storage, maintained in a safe, unadulterated condition during transportation, and served in meals or as entrees only to customers at restaurants, or through vending machines, owned or operated by the same person that owns or operates such facility, and which otherwise meets the requirement of this paragraph: Provided, That the requirements of §§ 381.175 through 381.178 of this subchapter apply to such facility. Provided further, That the exempted facility may be subject to inspection requirements under the Act for as long as the Administrator deems necessary if the Administrator determines that the sanitary conditions or practices of the facility or the processing procedures or methods at the facility are such that any of its poultry products are rendered adulterated. When the Administrator has made such determination and subjected a restaurant central kitchen facility to such inspection requirements, the operator of such facility shall be afforded an opportunity to dispute the Administrator's determination in a hearing pursuant to rules of practice which will be adopted for this proceeding.

(v) A similar retail-type establishment is any establishment which is a combination retail store and restaurant; any delicatessen which meets the requirements for a retail store or restaurant as prescribed in paragraph (d)(2) (iii) or (iv) of this section; or other establishment as determined by the Administrator in specific cases.

(vi) A consumer is any household consumer, hotel, or restaurant, or similar institution as determined by the Administrator in specific cases.

(3) Whenever any complaint is received by the Administrator from any person alleging that any retail establishment or restaurant claiming exemption under this paragraph (d) in any State or organized territory designated under both sections 5(c) and 11 of the Act as a jurisdiction that does not have or is not exercising adequate authority with respect to recordkeeping requirements, has been operated in violation of the conditions prescribed in this paragraph (d) for such exemption, and the Administrator, upon investigation of the complaint, has reason to believe that any such violation has occurred, he shall so notify the operator of the retail establishment or restaurant and afford him reasonable opportunity to present his views informally with respect to the matter. Thereafter, if the Administrator determines that such a violation has occurred, and that a requirement that the operator keep records concerning the operations of the retail establishment or restaurant would effectuate the purposes of the Act, the Administrator shall order the operator to maintain complete, accurate, and legible records of his total monthly purchases and of his total monthly sales of poultry and poultry products. Such records shall separately show total sales to household consumers and total sales to other consumers, and shall be maintained for the period prescribed in § 381.177. If the operator maintains copies of bills of lading, receiving and shipping invoices, warehouse receipts, or similar documents which give the information required herein, additional records are not required by this subparagraph.

(4) The adulteration and misbranding provisions of the Act and the regulations other than the requirement of the official inspection legend, apply to articles which are exempted from inspection under this paragraph (d).

(e)(1) The requirements of the Act and the regulations in this subchapter for inspection of the preparation of products do not apply to poultry pizzas containing poultry product ingredients which were prepared, inspected, and passed in a cured or cooked form as ready-to-eat (i.e., no further cooking or other preparation is needed) in compliance with the requirements of the Act and these regulations; and the poultry pizzas are to be served in public or private nonprofit institutions, provided that the poultry pizzas are ready to eat (i.e., no further cooking or other preparation is needed, except that they may be reheated prior to serving if chilled during transportation), transported directly to the receiving institution by employees of the preparing firm, receiving institution, or a food service management company contracted to conduct food service at the public or private nonprofit institution, without intervening transfer or storage.

(2) The definitions at Chapter 1, 1-102, except 1-102(z) and the provisions of Chapters 2 through 8, except sections 2-102 (a) and (b), 2-302(d), 2-403(a), 2-403(c), 2-404, 2-405, 2-407, 2-502 through 2-506, 2-508, 2-509, 4-105, 4-201(c), 4-208, 5-101(a), 5-103, 5-104, 5-202(c), 5-203, and 6-105, Part IV, of the Food and Drug Administration's Food Service Sanitation Manual (1976 Recommendations), DHEW Publication No. (FDA) 78-2081, which is incorporated by reference, shall apply to the facilities and operations of businesses claiming this exemption. (These materials are incorporated as they exist on the date of approval. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be purchased from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402. It is also available for inspection at the FSIS Hearing Clerk, room 3171, South Building, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250 or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(3) Facilities and operations of businesses claiming this exemption shall also conform to the following requirements:

(i) Manual cleaning and sanitizing. (A) For manual washing, rinsing and sanitizing of utensils and equipment, a sink with not fewer than three compartments shall be provided and used. Sink compartments shall be large enough to permit the accommodation of the equipment and utensils, and each compartment of the sink shall be supplied with hot and cold potable running water. Fixed equipment and utensils and equipment too large to be cleaned in sink compartments shall be washed manually or cleaned through pressure spray methods.

(B) Drain boards or easily movable dish tables of adequate size shall be provided for proper handling of soiled utensils prior to washing and for cleaned utensils following sanitizing and shall be located so as not to interfere with the proper use of the dishwashing facilities.

(C) Equipment and utensils shall be preflushed or prescraped and, when necessary, presoaked to remove gross food particles and soil.

(D) Except for fixed equipment and utensils too large to be cleaned in sink compartments, manual washing, rinsing and sanitizing shall be conducted in the following sequence:

( 1 ) Sinks shall be cleaned prior to use.

( 2 ) Equipment and utensils shall be thoroughly washed in the first compartment with a hot detergent solution that is kept clean.

( 3 ) Equipment and utensils shall be rinsed free of detergent and abrasives with clean water in the second compartment.

( 4 ) Equipment and utensils shall be sanitized in the third compartment according to one of the methods prescribed in paragraph (e)(3)(i)(E) ( 1 ) through ( 4 ) of this section.

(E) The food-contact surfaces of all equipment and utensils shall be sanitized by:

( 1 ) Immersion for at least

1/2 minute in clean, hot water at a temperature of at least 170 °F; or

( 2 ) Immersion for at least 1 minute in a clean solution containing at least 50 parts per million of available chlorine as a hypochlorite and at a temperature of at least 75 °F; or

( 3 ) Immersion for at least 1 minute in a clean solution containing at least 12.5 parts per million of available iodine and having a pH not higher than 5.0 and at a temperature of at least 75 °F; or

( 4 ) Immersion in a clean solution containing any other chemical sanitizing agent allowed under 21 CFR 178.1010 that will provide the equivalent bactericidal effect of a solution containing at least 50 parts per million of available chlorine as a hypochlorite at a temperature of at least 75 °F for 1 minute; or

( 5 ) Treatment with steam free from materials or additives other than those specified in 21 CFR 173.310 in the case of equipment too large to sanitize by immersion, but in which steam can be confined; or

( 6 ) Rinsing, spraying, or swabbing with a chemical sanitizing solution of at least twice the strength required for that particular sanitizing solution under paragraph (e)(3)(i)(E)( 4 ) of this section in the case of equipment too large to sanitize by immersion.

(F) When hot water is used for sanitizing, the following facilities shall be provided and used:

( 1 ) An integral heating device or fixture installed in, on, or under the sanitizing compartment of the sink capable of maintaining the water at a temperature of at least 170 °F; and

( 2 ) A numerically scaled indicating thermometer, accurate to ±3 °F, convenient to the sink for frequent checks of water temperature; and

( 3 ) Dish baskets of such size and design to permit complete immersion of the tableware, kitchenware, and equipment in the hot water.

(G) When chemicals are used for sanitization, they shall not have concentrations higher than the maximum permitted under 21 CFR 178.1010 and a test kit or other device that accurately measures the parts per million concentration of the solution shall be provided and used.

(ii) Mechanical cleaning and sanitizing. (A) Cleaning and sanitizing may be done by spray-type or immersion dishwashing machines or by any other type of machine or device if it is demonstrated that it thoroughly cleans and sanitizes equipment and utensils. These machines and devices shall be properly installed and maintained in good repair. Machines and devices shall be operated in accordance with manufacturers' instructions, and utensils and equipment placed in the machine shall be exposed to all dishwashing cycles. Automatic detergent dispensers, wetting agent dispensers, and liquid sanitizer injectors, if any, shall be properly installed and maintained.

(B) The pressure of final rinse water supplied to spray-type dishwashing machines shall not be less than 15 nor more than 25 pounds per square inch measured in the water line immediately adjacent to the final rinse control valve. A

1/4 -inch IPS valve shall be provided immediately upstream from the final rinse control valve to permit checking the flow pressure of the final rinse water.

(C) Machine or water line mounted numerically scaled indicating thermometers, accurate to ±3 °F, shall be provided to indicate the temperature of the water in each tank of the machine and the temperature of the final rinse water as it enters the manifold.

(D) Rinse water tanks shall be protected by baffles, curtains, or other effective means to minimize the entry of wash water into the rinse water. Conveyors in dishwashing machines shall be accurately timed to assure proper exposure times in wash and rinse cycles in accordance with manufacturers' specifications attached to the machines.

(E) Drain boards shall be provided and be of adequate size for the proper handling of soiled utensils prior to washing and of cleaned utensils following sanitization and shall be so located and constructed as not to interfere with the proper use of the dishwashing facilities. This does not preclude the use of easily movable dish tables for the storage of soiled utensils or the use of easily movable dishtables for the storage of clean utensils following sanitization.

(F) Equipment and utensils shall be flushed or scraped and, when necessary, soaked to remove gross food particles and soil prior to being washed in a dishwashing machine unless a prewashcycle is a part of the dishwashing machine operation. Equipment and utensils shall be placed in racks, trays, or baskets, or on conveyors, in a way that food-contact surfaces are exposed to the unobstructed application of detergent wash and clean rinse waters and that permits free draining.

(G) Machines (single-tank, stationary-rack, door-type machines and spray-type glass washers) using chemicals for sanitization may be used: Provided, That,

( 1 ) The temperature of the wash water shall not be less than 120 °F.

( 2 ) The wash water shall be kept clean.

( 3 ) Chemicals added for sanitization purposes shall be automatically dispensed.

( 4 ) Utensils and equipment shall be exposed to the final chemical sanitizing rinse in accordance with manufacturers' specifications for time and concentration.

( 5 ) The chemical sanitizing rinse water temperature shall be not less than 75 °F nor less than the temperature specified by the machine's manufacturer.

( 6 ) Chemical sanitizers used shall meet the requirements of 21 CFR 178.1010.

( 7 ) A test kit or other device that accurately measures the parts per million concentration of the solution shall be available and used.

(H) Machines using hot water for sanitizing may be used provided that wash water and pumped rinse water shall be kept clean and water shall be maintained at not less than the following temperatures:

( 1 ) Single-tank, stationary-rack, dual-temperature machine:

Wash temperature

150 °F

Final rinse temperature

180 °F

( 2 ) Single-tank, stationary-rack, single-temperature machine:

Wash temperature

165 °F

Final rinse temperature

165 °F

( 3 ) Single-tank, conveyor machine:

Wash temperature

160 °F

Final rinse temperature

180 °F

( 4 ) Multitank, conveyor machine:

Wash temperature

150 °F

Pumped rinse temperature

160 °F

Final rinse temperature

180 °F

( 5 ) Single-tank, pot, pan, and utensil washer (either stationary or moving-rack):

Wash temperature

140 °F

Final rinse temperature

180 °F

(I) All dishwashing machines shall be thoroughly cleaned at least once a day or more often when necessary to maintain them in a satisfactory operating condition.

(iii) Steam. Steam used in contact with food or food-contact surfaces shall be free from any materials or additives other than those specified in 21 CFR 173.310.

(4) For purposes of this paragraph, the term “private nonprofit institution” means “a corporation, and any community chest, fund, or foundation, organized and operated exclusively for religious, charitable, scientific, testing for public safety, literary, or educational purposes, or to foster national or international amateur sports competition (but only if no part of its activities involve the provision of athletic facilities or equipment), or for the prevention of cruelty to children or animals, no part of the net earnings of which inures to the benefit of any private shareholder or individual, no substantial part of the activities of which is carrying on propaganda, or otherwise attempting, to influence legislation, and which does not participate in, or intervene in (including the publishing or distribution of statements), any political campaign on behalf of (or in opposition to) any candidate for public office.”

(5) The Administrator may withdraw or modify the exemption set forth in § 381.10(e)(1) for a particular establishment when he or she determines that such action is necessary to ensure food safety and public health. Before such action is taken, the owner or operator of the particular establishment shall be notified, in writing, of the reasons for the proposed action and shall be given an opportunity to respond, in writing, to the Administrator within 20 days after notification of the proposed action. The written notification shall be served on the owner or operator of the establishment in the manner prescribed in section 1.147(b) of the Department's Uniform Rules of Practice (7 CFR 1.147(b)). In those instances where there is conflict of any material fact, the owner or operator of the establishment, upon request, shall be afforded an opportunity for a hearing with respect to the disputed fact, in accordance with rules of practice which shall be adopted for the proceeding. However, such withdrawal or modification shall become effective pending final determination in the proceeding when the Administrator determines that an imminent threat to food safety or public health exists, and that such action is, therefore, necessary to protect the public health, interest or safety. Such withdrawal or modification shall be effective upon oral or written notification, whichever is earlier, to the owner or operator of the particular establishment as promptly as circumstances permit. In the event of oral notification, written confirmation shall be given to the owner or operator of the establishment as promptly as circumstances permit. This withdrawal or modification shall continue in effect pending the completion of the proceeding and any judicial review thereof, unless otherwise ordered by the Administrator.

(6) The adulteration and misbranding provisions of the Act and the regulations apply to articles which are exempted from inspection under § 381.10(e).

§ 381.11 Exemptions based on religious dietary laws.

(a) Any person who slaughters, processes, or otherwise handles poultry or poultry products which have been or are to be processed as required by recognized religious dietary laws may apply for exemption from specific provisions of the Act or regulations which are in conflict with such religious dietary laws. Any person desiring such an exemption shall apply in writing to the Meat and Poultry Inspection Program, Food Safety and Inspection Service, Department of Agriculture, Washington, DC 20250, setting forth the specific provisions of the Act and the regulations from which exemption is sought and setting forth the provisions of the religious dietary laws in support of the requested exemption. In addition, the applicant for such an exemption shall submit a statement from the clerical official having jurisdiction over the enforcement of the religious dietary laws with respect to the poultry or poultry products involved, which identifies the requirements of such laws pertaining to the slaughter of the poultry and the processing or other handling of the poultry products involved, and certifies that such requirements are in conflict with specific provisions of the Act and regulations from which the exemption is sought.

(b) The Administrator, upon a determination that an exemption should be granted, will grant such exemption to the extent necessary to avoid conflict with the religious requirements while still effectuating the purposes of the Act. He may impose such conditions as to sanitary standards, practices, and procedures in granting such exemption as he deems necessary to effectuate the purposes of the Act. Any person who processes poultry or poultry products under exemption from certain requirements as provided in this section shall be subject to all of the other applicable provisions of the Act and the regulations. Processing plants shall meet the sanitary requirements set forth in this part and unless exempted from inspection under the provisions of this subpart, shall be required to qualify for inspection and operate as official establishments. Slaughtered poultry which is prepared under an exemption authorizing the sale of noneviscerated poultry in commerce shall be individually identified with a label approved by the Administrator which identifies the clerical official under whose supervision the poultry was slaughtered.

§ 381.12 Effect of religious dietary laws exemptions on other persons.

Whenever a slaughterer or processor is granted an exemption under § 381.11 with respect to the slaughtering or processing of any poultry or poultry products under this part, under specified conditions, the sale, offer for sale, transportation and other handling in commerce by any person of such poultry and poultry products in accordance with such conditions is hereby authorized, except as restricted by the Act.

§ 381.13 Suspension or termination of exemptions.

(a) The Administrator may, by order, in accordance with the applicable rules of practice suspend or terminate any exemption under § 381.10(a) with respect to any person whenever he finds that such action will aid in effectuating the purposes of the Act. Failure to comply with the conditions of the exemption, including, but not limited to, failure to process poultry and poultry products under clean and sanitary conditions may result in termination of an exemption, in addition to any other penalties provided by law.

(b) Except as provided in § 381.10(c), the Administrator may extend the requirements of the Act to any establishment in any State or organized territory at which poultry products are processed for distribution solely within such jurisdiction if he determines in accordance with the provisions of subparagraph 5(c)(1) of the Act that the establishment is producing adulterated poultry products which would clearly endanger the public health.

§ 381.14 Inspection concerning purportedly exempted operations.

Inspectors of the Inspection Service are authorized to make inspections in accordance with law to ascertain whether any of the provisions of the Act or the regulations applying to producers, retailers, or other persons purporting to be exempted from any requirements under this subpart have been violated.

§ 381.15 Exemption from definition of “poultry product” of certain human food products containing poultry.

The following articles contain poultry ingredients only in a relatively small proportion or historically have not been considered by consumers as products of the poultry food industry. Therefore said articles are exempted from the definition of “poultry product” and the requirements of the Act and the regulations applicable to poultry products, if they comply with the conditions specified in this section.

(a) Any human food product (in a consumer package) not provided for in paragraph (c) of this section, if:

(1) It contains less than 2 percent cooked poultry meat (deboned white or dark poultry meat, or both) and/or “Mechanically Separated (Kind of Poultry)” as defined in § 381.173;

(2) It contains less than 10 percent of cooked poultry skins, giblets, or fat, separately, and less than 10 percent of cooked poultry skins, giblets, fat, and meat (as meat is limited in paragraph (a)(1) of this section) or “Mechanically Separated (Kind of Poultry)” as defined in § 381.173, in any combination;

(3) The poultry ingredients used in the product were prepared under inspection as defined in § 381.1, or were inspected under a foreign inspection system approved under § 381.196(b) and imported in compliance with the Act and the regulations;

(4) The immediate container of the product bears a label which shows the name of the product in accordance with this section; and

(5) The product is not represented as a poultry product. The aforesaid percentages of ingredients shall be computed on the basis of the moist, deboned, cooked poultry in the ready-to-serve product when prepared according to the serving directions on the consumer package.

(b) Any human food product (in an institutional pack), not provided for in paragraph (c) of this section, if:

(1) It is prepared for sale only to institutional users, such as hotels, restaurants, and boardinghouses, for use as a soup base or flavoring;

(2) It contains less than 15 percent cooked poultry meat (deboned white or dark poultry meat or both) and/or “Mechanically Separated (Kind of Poultry)” as defined in § 381.173, computed on the basis of the moist deboned, cooked poultry meat and/or “Mechanically Separated (Kind of Poultry)” in such product; and

(3) It complies with the provisions of paragraphs (a)(3), (4), and (5) of this section in all respects.

(c) Bouillon cubes, poultry broths, gravies, sauces, seasonings, and flavorings if:

(1) They contain poultry meat and/or “Mechanically Separated (Kind of Poultry)” as defined in § 381.173 or poultry fat only in condimental quantities;

(2) They comply with the provisions of paragraphs (a)(3), (4), and (5) of this section in all respects; and

(3) In the case of poultry broth, it will not be used in the processing of any poultry product in any official establishment.

(d) Fat capsules and sandwiches containing poultry products if they comply with the provisions of paragraphs (a)(3), (4), and (5) of this section in all respects.

(e) Products of the types specified in this section except those specified in paragraphs (c) and (d) of this section will be deemed to be represented as poultry products if the kind name of the poultry (chicken, turkey, etc.) is used in the product name of the product without appropriate qualification. For example, a consumer-packaged noodle soup product containing less than 2 percent chicken meat on a ready-to-serve basis may not be labeled “Chicken Noodle Soup” but, when appropriate, could be labeled as “Chicken Flavored Noodle Soup.” Products exempted under this section are subject to the requirements of the Federal Food, Drug, and Cosmetic Act.

§ 381.16 How application shall be made.

The operator of each establishment of the kind required by § 381.6 to have inspection shall make application to the Administrator for inspection service. In cases of change of name, ownership, or location, a new application shall be made.

§ 381.17 Filing of application.

Every application for inspection at any establishment shall be made by the operator on a form furnished by the Meat and Poultry Inspection Program, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250, and shall include all information called for by that form, including the name of any subsidiary corporation that will prepare any poultry product or conduct any other operation at the establishment for which inspection is requested. The applicant for inspection will be held responsible for compliance by all its subsidiaries with the requirements of the regulations at such establishments if inspection is granted. Processing of poultry products and other operations at the establishment for which inspection is granted may be conducted only by the applicant, except that such a subsidiary of the grantee, may conduct such operations at such establishment.

§ 381.18 Authority of applicant.

Any person applying for inspection service may be required at the discretion of the Administrator to demonstrate that the operator of the establishment authorized him to do so.

§ 381.20 Survey and grant of inspection.

(a) Before inspection is granted, FSIS shall survey the establishment to determine if the construction and facilities of the establishment are in accordance with the regulations. FSIS will grant inspection, subject to § 381.21, when these requirements are met.

(b) FSIS shall give notice in writing to each applicant granted inspection and shall specify in the notice the establishment, including the limits of the establishment's premises, to which the grant pertains.

§ 381.21 Refusal of inspection.

(a) Any application for inspection in accordance with this part may be denied or refused in accordance with the rules of practice in part 500 of this chapter.

(b)(1) Any applicant for inspection at an establishment where the operations thereof may result in any discharge into the navigable waters of the United States is required by subsection 21(b) of the Federal Water Pollution Control Act, as amended, to provide the Administrator with a certification as prescribed in said subsection that there is reasonable assurance that such activity will be conducted in a manner which will not violate the applicable water quality standards. No grant of inspection can be issued after April 3, 1970 (the date of enactment of the Water Quality Improvement Act), unless such certification has been obtained, or is waived because of failure or refusal of the State, interstate agency, or the Administrator of the Environmental Protection Agency to act on a request for certification within 1 year after receipt of such request. Further, upon receipt of an application for inspection and a certification as required by subsection 21(b) of the Federal Water Pollution Control Act, the Administrator (as defined in § 381.1) is required by paragraph (2) of said subsection to notify the Administrator of the Environmental Protection Agency for proceedings in accordance with that paragraph. No grant of inspection can be made until the requirements of said paragraph (2) have been met.

(2) However, certification under subsection 21(b) of the Federal Water Pollution Control Act is not initially required in connection with an application for inspection granted after April 3, 1970, for facilities existing or under construction on April 3, 1970, although certification for such facilities is required to be obtained within the 3-year period immediately following April 3, 1970. Failure to obtain such certification or to meet the other requirements of subsection 21(b) prior to April 3, 1973, will result in the termination of inspection at such facilities on that date.

(3) Further, any application for inspection pending on April 3, 1970, and granted within 1 year thereafter shall not require certification for 1 year following the grant of inspection but such grant of inspection shall terminate at the end of 1 year after its issuance unless prior thereto such certification has been obtained and the other requirements of subsection 21(b) are met.

(4) In the case of any activity which will affect water quality but for which there are no applicable water quality standards, no certification is required prior to the grant of inspection but such grant will be conditioned upon a requirement of compliance with the purpose of the Federal Water Pollution Control Act as provided in paragraph 21(b)(9) of said Act.

§ 381.22 Conditions for receiving inspection.

(a) Before being granted Federal inspection, an official establishment or an official import inspection establishment, must have developed written Sanitation Standard Operating Procedures, as required by part 416 of this chapter, and written recall procedures as required by part 418 of this chapter.

(b) Before being granted Federal inspection, an establishment shall have conducted a hazard analysis and developed and validated a HACCP plan, in accordance with §§ 417.2 and 417.4 of this chapter. A conditional grant of inspection shall be issued for a period not to exceed 90 days, during which period the establishment must validate its HACCP plan.

(c) Before producing new product for distribution in commerce, an establishment shall have conducted a hazard analysis and developed a HACCP plan applicable to that product in accordance with § 417.2 of this chapter. During a period not to exceed 90 days after the date the new product is produced for distribution in commerce, the establishment shall validate its HACCP plan, in accordance with § 417.4 of this chapter.

§ 381.25 Official establishment numbers.

An official establishment number shall be assigned to each establishment granted inspection service. Such number shall be used to identify all containers of inspected poultry products prepared in the establishment. An establishment shall not have more than one establishment number.

§ 381.26 Separation of establishments.

Each official establishment shall be separate and distinct from any other official establishment and from any unofficial establishment except an establishment preparing meat products under the Federal Meat Inspection Act or under State meat inspection. Further, doorways, or other openings, may be permitted between establishments at the discretion of the Administrator and under such conditions as he may prescribe.

§ 381.27 Inauguration of service; notification concerning regulations; status of uninspected poultry products.

The inspector in charge or his supervisor shall, upon or prior to the inauguration of service, inform the operator of the establishment of the requirements of the regulations. If the establishment at the time service is inaugurated contains any poultry product which has not been inspected and marked in compliance with the regulations, its identity shall be maintained, and it shall not be represented or dealt with as a product which has been inspected. Such products may not be shipped in commerce unless such products are eligible for such shipment under an exemption from inspection under subpart C and comply with all requirements of said subpart.

§ 381.28 Report of violations.

Each inspector, agent, representative, or employee of the Inspection Service shall report, in the manner prescribed by the Administrator, all violations of the Act and noncompliance with the regulations of which he has knowledge.

§ 381.32 Access to establishments.

[See § 300.6 of this chapter regarding access to establishments and other places of business.]

§ 381.33 Identification.

Each inspector will be furnished with a numbered official inspection badge, which shall remain in his or her possession at all times, and which shall be worn in such manner and at such times as the Administrator may prescribe.

§ 381.34 Financial interest of inspectors.

(a) No inspector shall inspect any poultry or poultry product in which he, his spouse, minor child, partner, organization in which he is serving as officer, director, trustee, partner, or employee, or any person with whom he is negotiating or has any arrangement concerning prospective employment, is financially interested.

(b) All inspectors are subject to statutory restrictions with respect to political activities; e.g., 5 U.S.C. 7324 and 1502.

(c) Violation of the provisions of paragraph (a) of this section or the provisions of applicable statutes referenced in paragraph (b) of this section will constitute grounds for dismissal in the case of appointees and for revocation of licenses in the case of licensees.

(d) Inspectors are subject to all applicable provisions of law and regulations and instructions of the Department and the Food Safety and Inspection Service and other authority concerning employee responsibilities and conduct. The setting forth of certain prohibitions in this part in no way limits the applicability of such general or other regulations or instructions.

§ 381.35 Appeal inspections; how made.

Any person receiving inspection service may, if dissatisfied with any decision or action of an inspector or other Agency employee relating to any inspection, file an appeal from such decision or action in accordance with 9 CFR 500.9.

§ 381.36 Facilities required.

(a) Inspector's Office. Office space, including, but not being limited to furnishings, light, heat, and janitor service, shall be provided rent free in the official establishment, for the use of Government personnel for official purposes. The room or space set apart for this purpose must meet the approval of the Inspection Service and be conveniently located, properly ventilated, and provided with lockers or file cabinets suitable for the protection and storage of supplies and with facilities suitable for inspectors to change clothing. At the discretion of the Administrator, small plants requiring the services of less than one full-time inspector need not furnish facilities for Program employees as prescribed in this section, where adequate facilities exist in a nearby convenient location. Each official establishment shall provide commercial laundry service for inspectors' outer work clothing, or disposable outer work garments designed for one-time use, or uniform rental service garments which are laundered by the rental service.

(b) Facilities for ante mortem inspection. A suspect pen is required for adequate ratite inspection.

(c) Facilities for the Streamlined Inspection System (SIS). The following requirements for lines operating under SIS are in addition to the normal requirements to obtain a grant of inspection. The requirements for SIS in § 381.76(b) also apply.

(1) The following provisions shall apply to every inspection station:

(i) The conveyor line shall be level for the entire length of the inspection station. The vertical distance from the bottom of the shackles to the top of the adjustable platform (paragraph (c)(1)(iv) of this section) in its lowest position shall not be less than 60 inches.

(ii) Floor space shall consist of 4 feet along the conveyor line for the inspector, and 4 feet for the establishment helper. A total of at least 8 feet along the conveyor line shall be supplied for one inspection station and 16 feet for two-inspection stations.

(iii) Selectors or “kickouts” shall be installed in establishments with two inspection stations on a line so each inspector will receive birds on 12-inch centers with no intervening birds to impede inspection. The selector must move the bird to the edge of the trough for the inspector and establishment helper. The selectors must be smooth, steady, and consistent in moving the birds parallel and through the inspection station. Birds shall be selected and released smoothly to avoid swinging when entering the inspection station.

(iv) Each inspector's station shall have a platform that is slip-resistant and can be safely accessed by the inspector. The platform shall be designed so that it can be easily and rapidly adjusted for a minimum of 14 inches vertically while standing on the platform. The platform shall be a minimum length of 4 feet and have a minimum width of 2 feet; the platform shall be designed with a 42-inch high rail on the back side and with

1/2 -inch foot bumpers on both sides and front to allow safe working conditions. The platform must have a safe lift mechanism and be large enough for the inspector to sit on a stool and to change stations during breaks or station rotation.

(v) Conveyor line stop/start switches shall be located within easy reach of each inspector.

(vi) A trough or other facilities shall extend beneath the conveyor at all places where processing operations are conducted from the point where the carcass is opened to the point where the trimming has been performed. The trough must be of sufficient width to preclude trimmings, drippage, and debris from accumulating on the floor or platforms. The clearance between the suspended carcasses and the trough must be sufficient to preclude contamination of carcasses by splash.

(vii) A minimum of 200-footcandles of shadow-free lighting with a minimum color rendering index value of 85 where the birds are inspected to facilitate inspection.

(viii) Online handrinsing facilities with a continuous flow of water must be provided for and within easy reach of each inspector and each establishment helper. The hand-contact element must be rinsed automatically with a sufficient volume of water to remove all fat, tissue, debris, and other extraneous material from the hand contact element after each use. Both hot and cold running water shall be available at each inspection station on the eviscerating line and shall be delivered through a suitable mixing device controlled by the inspector. Alternatively, water for hand washing shall be delivered to such inspection stations at a minimum temperature of 65 degrees F.

(ix) Hangback racks shall be provided for and positioned within easy reach of the establishment helpers.

(x) Each inspection station shall be provided with receptacles for condemned carcasses and parts. Such receptacles shall comply with the performance standards in § 416.3(c) of this chapter.

(2) The following provisions shall apply only to prechill and postchill reinspection stations:

(i) Floor space shall consist of a minimum of 3 feet along each conveyor line and after each chiller to allow carcasses to be removed for evaluation. The space shall be level and protected from all traffic and overhead obstructions.

(ii) The vertical distance from the bottom of the shackles to the floor shall not be less than 48 inches.

(iii) A table, at least 2 feet wide, 2 feet deep, and 3 feet high designed to be readily cleanable and drainable shall be provided for reinspecting the sampled birds.

(iv) A minimum of 200-footcandles of shadow-free lighting with a minimum color rendering index of 85 on the table surface shall be provided.

(v) A separate clip board holder shall be provided for holding the recording sheets.

(vi) Handwashing facilities shall be provided for and shall be within easy access of persons working at the stations.

(vii) Hangback racks designed to hold 10 carcasses shall be provided for and positioned within easy reach of the person at the station.

(d) Facilities for the New Line Speed (NELS) inspection system. The following requirements for lines operating under the NELS inspection system are in addition to the normal requirements to obtain a grant of inspection and to the requirements for NELS in § 381.76 (b) and (c).

(1) The following provisions shall apply to every inspection station:

(i) The conveyor line shall be level for the entire length of the inspection station. The vertical distance from the bottom of the shackles to the top of the adjustable platform (paragraph (d)(1)(iv) of this section) in its lowest position shall not be less than 60 inches.

(ii) Floor space shall consist of 6 feet along the conveyor line for the establishment employee presenting the birds, 4 feet for the inspector, and 4 feet for the establishment helper. A total of at least 42 feet along the conveyor line shall be supplied for three inspection stations.

(iii) Selectors or “kickouts” shall be installed so the three inspection stations will receive birds on 18-inch centers with no intervening birds to impede inspection. The selector must move the bird to the end of the trough for the presenter, inspector, and establishment helper. The selectors must be smooth, steady, and consistent in moving the birds parallel and through the inspection station. Birds shall be selected and released smoothly to avoid splashing the mirror (paragraph (d)(1)(vii) of this section) and swinging when entering the inspection station. Guide bars shall not extend in front of the inspection station mirror to avoid obstructing the inspector's view.

(iv) Each inspector's station shall have an easily and rapidly adjustable platform, with a minimum of 14 inches of vertical adjustment, which covers the entire length of the station (4 feet) and has a minimum width of 2 feet. The platform shall be designed with a 42-inch high rail on the back side and with

1/2 -inch foot bumpers on both sides and front to allow safe working conditions.

(v) Conveyor line stop/start switches shall be located within easy reach of each inspector.

(vi) A trough shall extend beneath the conveyor at all places where processing operations are conducted from the point where the carcass is opened to the point where the trimming has been performed. The trough must be of sufficient width to preclude trimmings, drippage, and debris from accumulating on the floor or platforms. The clearance between the suspended carcasses and the trough must be sufficient to preclude contamination of carcasses by splash.

(vii) A distortion-free mirror, at least 3 feet wide and 2 feet high, shall be mounted at each inspection station so that it can be adjusted between 5 and 15 inches behind the shackles, tilt up and down, tilt from side to side, and be raised and lowered. The mirror shall be positioned in relation to the inspection platform so that the inspector can position himself/herself opposite it 8 to 12 inches from the downstream edge. The mirror must be maintained abrasion free.

(viii) A minimum of 200-footcandles of shadow-free lighting with minimum color rendering index value of 85

1

where the birds are inspected to facilitate inspection. A light shall also be positioned above and slightly in front of the mirror to facilitate the illumination of the bird and mirror surfaces.

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

(ix) “One-line” handrinsing facilities with a continuous flow of water shall be provided for and within easy reach of each inspector and each establishment presenter and helper.

(x) Hangback racks shall be provided for and positioned within easy reach of the establishment helpers.

(xi) Each inspection station shall be provided with receptacle for condemned carcasses and parts. Such receptacles shall comply with the performance standards in § 416.3(c) of this chapter.

(2) The following provisions shall apply only to the reinspection station:

(i) Floor space shall consist of 6 feet along the conveyor line. The space shall be level and protected from all traffic and overhead obstructions.

(ii) The vertical distance from the bottom of the shackles to the floor shall not be less than 48 inches.

(iii) A table, at least 3 feet wide and 2 feet deep, shall be provided for reinspecting the sample birds.

(iv) A minimum of 200-footcandles of shows free lighting with a minimum color rendering index of 85

1 on the table surface.

(v) A separate clip board holder shall be provided for holding the recording sheets.

(vi) Handwashing facilities shall be provided for and shall be within easy reach of persons working at the station.

(vii) Hangback racks designed to hold 10 carcasses shall be provided for and positioned within easy reach of the person at the station.

(e) Facilities for the New Turkey Inspection (NTI) System. The following requirements for lines operating under the NTI System are in addition to the normal requirements to obtain a grant of inspection and to the requirements for the NTI System in § 381.76 (b) and (c).

(1) The following provisions apply to every inspection station:

(i) The conveyor line must be level for the entire length of the inspection station. The vertical distance from the bottom of the shackles to the top of the adjustable platform (paragraph (e)(1)(iii) of this section) in its lowest position shall not be less than 60 inches.

(ii) Floor space shall consist of 8 feet along the conveyor line; at least 4 feet for the inspector, and at least 4 feet for the establishment helper.

(iii) The inspector's station shall have an easily and rapidly adjustable platform with a minimum width of 2 feet which covers the entire length of the station (4 feet). The platform must adjust vertically a minimum of 14 inches, and must have a 42-inch rail on the back side and

1/2 -inch foot bumpers on the sides and the front to allow safe working conditions.

(iv) Conveyor line stop/start switches shall be located within easy reach of each inspector.

(v) A trough or other facilities shall extend beneath the conveyor at all places where processing operations are conducted from the point where the carcass is opened to the point where the trimming has been performed. The trough must be wide enough to prevent trimmings, drippage, and debris from accumulation on the floor or platforms. The clearance between suspended carcasses and the trough must be sufficient to prevent contamination of carcasses by splash.

(vi) A minimum of 200 foot-candles of shadow-free lighting with a minimum color rendering index value of 85

1

where the birds are inspected to facilitate inspection is required. The minimum lighting requirement for inspection stations in § 381.52(b) shall not apply.

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

(vii) On-line handrinsing facilities with a continuous flow of water shall be provided for and within easy reach of each inspector and each establishment helper.

(viii) Hangback racks shall be provided for and within easy reach of the establishment helper.

(ix) Each inspection station shall be provided with receptacles for condemned carcasses and parts. Such receptacles shall comply with the performance standards in § 416.3(c) of this chapter.

(2) The following provisions shall apply only to the reinspection station:

(i) Floor space shall consist of a minimum of 3 feet along the conveyor line so carcasses can be removed from each line for evaluation. The space shall be level and protected from all traffic and overhead obstructions.

(ii) The vertical distance from the bottom of the shackles to the floor must not be less than 48 inches.

(iii) A table at least 3 feet wide and 2 feet deep designed to be readily cleanable and drainable shall be provided for reinspecting the sampled birds.

(iv) A minimum of 200 foot-candles of shadow-free lighting with a minimum color rendering index of 85

1 at the table surface is required.

(v) A clipboard holder shall be provided for holding the recording sheets.

(vi) Handwashing facilities shall be provided for and within easy reach of persons working at the station.

(vii) Hangback racks designed to hold 10 carcasses shall be provided for and positioned within easy reach of the person at this station.

(f) Facilities for post-mortem inspection under the New Poultry Inspection System. The following facilities requirements apply to establishments operating under the New Poultry Inspection System and are in addition to the requirements for obtaining a grant of inspection.

(1) The following provisions apply to the online carcass inspection station:

(i) On each production line, at a point before the chiller and after the establishment has completed all sorting, trimming, and reprocessing activities necessary to comply with § 381.76(b)(6)(ii), at least 4 feet of floor space along the conveyor line must be provided for one online carcass inspection station.

(ii) The conveyor line must be level for the entire length of the online carcass inspection station. The vertical distance from the bottom of the shackles to the top of the platform (paragraph (f)(1)(iii) of this section) must not be less than 60 inches.

(iii) Each online carcass inspection station must have a platform that is slip-resistant and can be safely accessed by the inspector. The platform must be designed so that it can be easily and rapidly adjusted for a minimum of 14 inches vertically while standing on the platform. The platform must be a minimum length of 4 feet and have a minimum width of 2 feet. The platform must be designed with a 42-inch high rail on the back side and with

1/2 -inch foot bumpers on both sides and front to allow safe working conditions. The platform must have a safe lift mechanism and be large enough for the inspector to sit on a stool and to change stations during breaks or station rotation.

(iv) Conveyor line stop/start switches must be located within easy reach of the online carcass inspector.

(v) A minimum of 200 foot-candles of shadow-free lighting with a minimum color rendering index value of 85 must be provided where the birds are inspected to facilitate online carcass inspection.

(vi) Hand rinsing facilities must be provided for use by and within easy reach of the online carcass inspector. The hand rinsing facilities must have a continuous flow of water or be capable of being immediately activated and deactivated in a hands-free manner, must minimize any splash effect, and must otherwise operate in a sanitary manner that prevents contamination of carcasses and inspector clothing. The hand rinsing facilities must provide water at a temperature between 65 and 120 degrees Fahrenheit.

(vii) A separate clipboard holder for holding recording sheets must be provided for and within easy reach of the online carcass inspector.

(viii) Receptacles for condemned carcasses and parts that comply with the performance standards in § 416.3(c) of this chapter must be provided at each online carcass inspection station.

(ix) Hangback racks designed to hold at least 10 carcasses must be provided and positioned within easy reach of the online carcass inspector.

(x) A buzzer shall be located within easy reach of the online carcass inspector to be used by the carcass inspector to alert the inspector-in-charge, offline inspectors, or establishment management of conditions that require their attention.

(2) The following provisions apply to pre-chill and post-chill offline verification inspection stations:

(i) One or more offline verification inspection stations must be located at the end of the line or lines prior to the chiller. One or more offline verification inspection stations must also be located after the chiller or chillers. The Agency will determine the total number of offline verification inspection stations needed in establishments having more than one processing line or more than one chiller.

(ii) Floor space for all offline verification inspection stations must consist of a minimum of 3 feet along each conveyor line and after each chiller, as applicable, to allow carcasses to be removed for evaluation by the verification inspector. The space must be level and protected from all traffic and overhead obstructions.

(iii) At the pre-chill location, the vertical distance from the bottom of the shackles to the floor must not be less than 48 inches.

(iv) At each offline verification inspection station, a table designed to be readily cleanable and drainable must be provided for offline verification inspectors to conduct offline verification activities. At turkey slaughter establishments, the table must be at least 3 feet wide, 2 feet deep, and 3 feet high. At all other poultry slaughter establishments, the table must be at least 2 feet wide, 2 feet deep, and 3 feet high

(v) A minimum of 200 foot-candles of shadow-free lighting with a minimum color rendering index of 85 on the table surface must be provided.

(vi) The establishment must provide a separate clipboard holder for holding recording sheets; or alternatively, the establishment may provide electronic means for the offline verification inspector to record inspection results.

(vii) Hangback racks designed to hold at least 10 carcasses must be provided and positioned within easy reach of the offline verification inspector.

(viii) Hand washing facilities must be provided within easy access of all offline verification inspection stations.

(3) [Reserved]

(4) A trough or other similar drainage facility must extend beneath the conveyor at all places where processing operations are conducted from the point where the carcass is opened to the point where trimming has been performed. The trough must be of sufficient width to preclude trimmings, drippage, and debris from accumulating on the floor or platforms. The clearance between suspended carcasses and the trough must be sufficient to preclude contamination of carcasses by splashing.

§ 381.37 Schedule of operations.

(a) No operations requiring inspection shall be conducted except under the supervision of an Inspection Service employee. All eviscerating of poultry and further processing shall be done with reasonable speed, considering the official establishment's facilities.

(b) A shift is a regularly scheduled operating period, exclusive of mealtime. One lunch period is the only official authorized interruption in the inspector's tour of duty once it begins. Lunch periods may be 30 minutes, 45 minutes, or in any case may not exceed one hour in duration. Once established, the lunch period must remain relatively constant as to time and duration. Lunch periods for inspectors shall not, except as provided herein, occur prior to 4 hours after the beginning of scheduled operations nor later than 5 hours after operations begin. In plants where a company rest break of not less than 30 minutes is regularly observed, approximately midpoint between start of work and the lunch period, and the inspector is allowed this time to meet his personal needs, the lunch period may be scheduled as long as 5

1/2 hours after the beginning of scheduled operations.

(c) Official establishments, importers, and exporters shall be provided inspection service, without charge, up to 8 hours per shift during the basic workweek subject to the provisions of § 381.38: Provided, That any additional shifts meet requirements as determined by the Administrator or his designee. The basic workweek shall consist of 5 consecutive 8-hour days within the administrative workweek Sunday through Saturday, except that, when possible, the Department shall schedule the basic workweek so as to consist of 5 consecutive 8-hour days Monday through Friday. The 8-hour day excludes the lunch period but shall include activities deemed necessary by the Agency to fully carry out an inspection program, including the time for FSIS inspection program personnel to put on required gear, pick up required forms and walk to a work station; and the time for FSIS inspection program personnel to return from a work station, drop off required forms, and remove required gear; and to conduct duties scheduled by FSIS, including administrative duties. The Department may depart from the basic workweek in those cases where maintaining such a schedule would seriously handicap the Department in carrying out its functions. These provisions are applicable to all official establishments except in certain cases as provided in § 381.145(h) of this subchapter.

(d)(1) Each official establishment shall submit a work schedule to the area supervisor for approval. In consideration of whether the approval of an establishment work schedule shall be given, the area supervisor shall take in account the efficient and effective use of inspection personnel. The work schedule must specify the workweek, daily clock hours of operation, and lunch periods for all departments of the establishment requiring inspection.

(2) Establishments shall maintain consistent work schedules. Any request by an establishment for a change in its work schedule involving changes in the workweek or an addition or elimination of shifts shall be submitted to the area supervisor at least 2 weeks in advance of the proposed change. Frequent requests for change shall not be approved: Provided, however, Minor deviations from a daily operating schedule may be approved by the inspector in charge if such request is received on the day preceding the day of change.

(3) Requests for inspection service outside an approved work schedule shall be made as early in the day as possible for overtime work to be performed within that same workday; or made prior to the end of the day's operation when such a request will result in overtime service at the start of the following day: Provided, That an inspector may be recalled to his assignment after the completion of his daily tour of duty under the provisions of § 381.39(b).

§ 381.38 Overtime and holiday inspection service.

(a) The management of an official establishment, an importer, or an exporter shall reimburse the Program, at the rate specified in § 391.3, for the cost of the inspection service furnished on any holiday specified in paragraph (b) of this section; or for more than 8 hours on any day, or more than 40 hours in any administrative workweek Sunday through Saturday.

(b) Holidays for Federal employees shall be New Year's Day, January 1; Birthday of Martin Luther King, Jr., the third Monday in January; Washington's Birthday, the third Monday in February; Memorial Day, the last Monday in May; Independence Day, July 4; Labor Day, the first Monday in September; Columbus Day, the second Monday in October; Veterans' Day, November 11; Thanksgiving Day, the fourth Thursday in November; Christmas Day, December 25. When any of the above-listed holidays falls outside the basic workweek, the nearest workday within that week shall be the holiday.

§ 381.39 Basis of billing for overtime and holiday services.

(a) Each recipient of overtime or holiday inspection service, or both, shall be billed as provided for in § 381.38(a) and at the rate specified in § 391.3, in increments of quarter hours. For billing purposes, 8 or more minutes shall be considered a full quarter hour. Billing will be for each quarter hour of service rendered by each Inspection Service employee.

(b) Official establishments, importers, or exporters requesting and receiving the services of an Inspection Service employee after he has completed his day's assignment and left the premises, or called back to duty during any overtime or holiday period, shall be billed for a minimum of 2 hours overtime or holiday inspection service at the established rate.

(c) Bills are payable upon receipt and become delinquent 30 days from the date of the bill. Overtime or holiday inspection will not be performed for anyone having a delinquent account.

§ 381.45 Attestation requirements.

Each establishment that participates in the New Poultry Inspection System (NPIS) shall submit on an annual basis an attestation to the management member of the local FSIS circuit safety committee stating that it maintains a program to monitor and document any work-related conditions of establishment workers, and that the program includes the following elements:

(a) Policies to encourage early reporting of symptoms of injuries and illnesses, and assurance that it has no policies or programs in place that would discourage the reporting of injuries and illnesses.

(b) Notification to employees of the nature and early symptoms of occupational illnesses and injuries, in a manner and language that workers can understand, including by posting in a conspicuous place or places where notices to employees are customarily posted, a copy of the FSIS/OSHA poster encouraging reporting and describing reportable signs and symptoms.

(c) Monitoring on a regular and routine basis of injury and illness logs, as well as nurse or medical office logs, workers' compensation data, and any other injury or illness information available.

§ 381.46 Severability.

Should a court of competent jurisdiction hold any provision of this part 381, subpart H to be invalid, such action shall not affect any other provision of this part 381.

§ 381.65 Operations and procedures, generally.

(a) Operations and procedures involving the processing, other handling, or storing of any poultry product must be strictly in accord with clean and sanitary practices and must be conducted in a manner that will result in sanitary processing, proper inspection, and the production of poultry and poultry products that are not adulterated.

(b) Poultry must be slaughtered in accordance with good commercial practices in a manner that will result in thorough bleeding of the carcasses and ensure that breathing has stopped prior to scalding. Blood from the killing operation must be confined to a relatively small area.

(c) When thawing frozen ready-to-cook poultry in water, the establishment must use methods that prevent adulteration of, or net weight gain by, the poultry.

(d) The water used in washing the poultry must be permitted to drain freely from the body cavity.

(e) Detached ova may be collected for human food and handled only in accordance with 9 CFR 590.44 and may leave the establishment only to be moved to an official egg product processing plant for processing. Ova from condemned carcasses must be condemned and treated as required in § 381.95.

(f) Procedures for controlling visible fecal contamination. Official poultry slaughter establishments must develop, implement, and maintain written procedures to ensure that poultry carcasses contaminated with visible fecal material do not enter the chiller. Establishments must incorporate these procedures into their HACCP plans, or sanitation SOPs, or other prerequisite programs.

(g) Procedures for controlling contamination throughout the slaughter and dressing operation. Official poultry slaughter establishments must develop, implement, and maintain written procedures to prevent contamination of carcasses and parts by enteric pathogens and fecal contamination throughout the entire slaughter and dressing operation. Establishments must incorporate these procedures into their HACCP plans, or sanitation SOPs, or other prerequisite programs. At a minimum, these procedures must include sampling and analysis for microbial organisms in accordance with the sampling location and frequency requirements in paragraphs (g)(1) and (2) of this section to monitor their ability to maintain process control.

(1) Sampling locations. Establishments, except for very small establishments operating under Traditional Inspection or very low volume establishments operating under Traditional Inspection must collect and analyze samples for microbial organisms at the pre-chill and post-chill points in the process. Very small establishments operating under Traditional Inspection and very low volume establishments operating under Traditional Inspection must collect and analyze samples for microbial organisms at the post-chill point in the process.

(i) Very small establishments are establishments with fewer than 10 employees or annual sales of less than $2.5 million.

(ii) Very low volume establishments annually slaughter no more than 440,000 chickens, 60,000 turkeys, 60,000 ducks, 60,000 geese, 60,000 guineas, or 60,000 squabs.

(2) Sampling frequency. (i) Establishments, except for very low volume establishments as defined in paragraph (g)(1)(ii) of this section, must, at a minimum, collect and analyze samples at a frequency proportional to the establishment's volume of production at the following rates:

(A) Chickens. Once per 22,000 carcasses, but a minimum of once during each week of operation.

(B) Turkeys, ducks, geese, guineas, and squabs. Once per 3,000 carcasses, but at a minimum once each week of operation.

(ii) Very low volume establishments as defined in paragraph (g)(1)(ii) of this section must collect and analyze samples at least once during each week of operation starting June 1 of every year. If, after consecutively collecting 13 weekly samples, a very low volume establishment can demonstrate that it is effectively maintaining process control, it may modify its sampling plan.

(iii) Establishments must sample at a frequency that is adequate to monitor their ability to maintain process control for enteric pathogens. Establishments must maintain accurate records of all test results and retain these records as provided in paragraph (h) of this section.

(h) Recordkeeping requirements. Official poultry slaughter establishments must maintain daily records sufficient to document the implementation and monitoring of the procedures required under paragraph (g) of this section. Records required by this section may be maintained on computers if the establishment implements appropriate controls to ensure the integrity of the electronic data. Records required by this section must be maintained for at least one year and must be accessible to FSIS.

§ 381.66 Temperatures and chilling and freezing procedures.

(a) General. Temperatures and procedures that are necessary for chilling and freezing ready-to-cook poultry, including all edible portions thereof, must be in accordance with operating procedures that ensure the prompt removal of the animal heat, preserve the condition and wholesomeness of the poultry, and assure that the products are not adulterated.

(b) Chilling performance standards, except for ratites. (1)(i) Each official poultry slaughter establishment must ensure that all poultry carcasses, parts, and giblets are chilled immediately after slaughter operations so that there is no outgrowth of pathogens, unless such poultry is to be frozen or cooked immediately at the official establishment.

(ii) Previously chilled poultry carcasses and major portions must be kept chilled so that there is no outgrowth of the pathogens, unless such poultry is to be packed and frozen immediately at the official establishment.

(2) After product has been chilled, the establishment must prevent the outgrowth of pathogens on the product as long as the product remains at the establishment.

(3) The establishment must develop, implement, and maintain written procedures for chilling that address, at a minimum, the potential for pathogen outgrowth, the conditions affecting carcass chilling, and when its chilling process is completed. The establishment must incorporate these procedures into its HACCP plan, or sanitation SOP, or other prerequisite program.

(c) Ice and water chilling. (1) Only ice produced from potable water may be used for ice and water chilling, except that water and ice used for chilling may be reused in accordance with § 416.2(g). The ice must be handled and stored in a sanitary manner.

(2)(i) Poultry chilling equipment must be operated in a manner consistent with meeting the applicable pathogen reduction performance standards for raw poultry products as set forth in § 381.94 and the provisions of the establishment's HACCP plan.

(ii) Major portions of poultry carcasses, as defined in § 381.170(b)(22), may be chilled in water and ice.

(d) Water absorption and retention. (1) Poultry washing, chilling, and draining practices and procedures must be such as will minimize water absorption and retention at time of packaging.

(2) The establishment must provide scales, weights, identification devices, and other supplies necessary to conduct water tests.

(e) Air chilling. Air chilling is the method of chilling raw poultry carcasses and parts predominately with air. An antimicrobial intervention may be applied with water at the beginning of the chilling process, provided that its use does not result in any net pick-up of water or moisture during the chilling process. The initial antimicrobial intervention may result in some temperature reduction of the product, provided that the majority of temperature removal is accomplished exclusively by chilled air.

(f) Freezing. (1) Ready-to-cook poultry which is to be or is labeled with descriptive terms such as “fresh frozen,” “quick frozen” or “frozen fresh” or any other term implying a rapid change from a fresh state to a frozen state shall be placed into a freezer within 48 hours after initial chilling in accordance with paragraph (b) of this section. During this period, if such poultry is not immediately placed into a freezer after chilling and packaging, it shall be held at 36 °F. or lower.

(2) Ready-to-cook poultry shall be frozen in a manner so as to bring the internal temperature of the birds at the center of the package to 0 °F. or below within 72 hours from the time of entering the freezer. Such procedures shall not apply to raw poultry product described in § 381.129(b)(6)(i) of this subchapter.

(3) Upon written request, and under such conditions as may be prescribed by the Administrator, in specific cases, ready-to-cook poultry which is to be frozen immediately may be moved from the official establishment prior to freezing: Provided, That the plant and freezer are so located and such necessary arrangements are made that the Inspection Service will have access to the freezing room and adequate opportunity to determine compliance with the time and temperature requirements specified in paragraph (f)(2) of this section.

(4) Warm packaged ready-to-cook poultry which is to be chilled by immediate entry into a freezer within the official establishment shall within 2 hours from time of slaughter be placed in a plate freezer or a freezer with a functioning circulating air system where a temperature of −10 °F. or lower is maintained.

(5) Frozen poultry shall be held under conditions which will maintain the product in a solidly frozen state with temperature maintained as constant as possible under good commercial practice.

§ 381.67 Young chicken and squab slaughter inspection rate maximums under traditional inspection procedure.

The maximum number of birds to be inspected by each inspector per minute under the traditional inspection procedure for the different young chicken and squab slaughter line configurations are specified in the following table. These maximum rates will not be exceeded. The inspector in charge will be responsible for reducing production line rates where in the inspector's judgment the prescribed inspection procedure cannot be adequately performed within the time available, either because the birds are not presented by the official establishment in such a manner that the carcasses, including both internal and external surfaces and all organs, are readily accessible for inspection, or because the health conditions of a particular flock dictate a need for a more extended inspection procedure. The standards in 381.170(a) of this part specify which classes of birds constitute young chickens and squabs. Section 381.76(b) specifies when either the traditional inspection procedure or the modified traditional inspection procedure can or must be used.

Maximum Production Line Rates—Chickens and Squabs-Traditional Inspection Procedures

Line configuration 1

Number of inspection stations

Birds per inspector per minute

6-1

1

25

12-1

2

23

12-2

2

21

18-1

3

19

18-2

3

19

18-3

3

18

24-1

4

16 1 ⁄ 2

24-2

4

16

24-4

4

15 1 ⁄ 2

1 Birds are suspended on the slaughter line at 6-inch intervals. The first number indicates the interval in inches between the birds that each inspector examines. The second number indicates how many of the birds presented, the inspector is to inspect, i.e., “1” means inspect every bird. “4” means inspect every fourth bird, etc.

§ 381.68 Maximum inspection rates—New turkey inspection system.

(a) The maximum inspection rates for one inspector New Turkey Inspection (NTI-1 and NTI-1 Modified) and two inspectors New Turkey Inspection (NTI-2 and NTI-2 Modified) are listed in the table below. The line speeds for NTI-1 and NTI-2 are for lines using standard 9-inch shackles on 12-inch centers with birds hung on every shackle and opened with J-type or Bar-type opening cuts. The line speeds for NTI-1 Modified and NTI-2 Modified are for Bar-type cut turkey lines using a shackle with a 4-inch by 4-inch selector (or kickout), a 45 degree bend of the lower 2 inches, an extended central loop portion of the shackle that lowers the abdominal cavity opening of the carcasses to an angle of 30 degrees from the vertical in direct alignment with the inspector's view, and a width of 10.5 inches. Maximum rates for those establishments having varying configurations will be established by the Administrator but will not exceed those in the table. Neither the rates in the table nor those established for establishments with varying configurations shall be exceeded under any circumstances.

(b) There are two categories of turkeys for determining inspection rates, “light turkeys” and “heavy turkeys”. Light turkeys are all turkeys weighing less than 16 pounds. Heavy turkeys are all turkeys weighing 16 pounds or more. The weights refer to the bird at the point of post-mortem inspection, with blood, feathers and feet removed.

(c) The inspector in charge may reduce inspection line rates when in his/her judgment the prescribed inspection procedure cannot be adequately performed within the time available because the health conditions of a particular flock or other factors, including the manner in which birds are being presented to the inspector for inspection and the level of contamination among the birds on the line, dictate a need for a more extended inspection.

Maximum Turkey Inspection Rates

Inspection system

Line configuration

Number of inspectors

Birds/minute

J-Type

Bar-Type

(<16#) light

(>16#) 1 heavy

(<16#) light

(>16#) 1 heavy

NTI-1

12-1

1

32

30

25

21

NTI-2

2 24-2

2

51

41

45

35

NTI-1 Modified

12-1

1

—

—

32

30

NTI-2 Modified

2 24-2

2

—

—

51

41

1 This weight refers to the bird at the point of post-mortem inspection without blood or feet.

2 The turkeys are suspended on the slaughter line at 12-inch intervals with two inspectors each looking at alternating birds at 24-inch intervals.

§ 381.69 Maximum line speed rates under the New Poultry Inspection System.

(a) The maximum line speed for young chicken slaughter establishments that operate under the New Poultry Inspection System is 140 birds per minute.

(b) The maximum line speed for turkey slaughter establishments that operate under the New Poultry Inspection System is 55 birds per minute.

(c) Notwithstanding paragraphs (a) and (b) of this section, establishments that operate under the New Poultry Inspection System must reduce their line speed as directed by inspectors-in-charge. Inspectors-in-charge are authorized to direct establishments to operate at a reduced line speed when in their judgment a carcass-by-carcass inspection cannot be adequately performed within the time available due to the manner in which the birds are presented to the online carcass inspector, the health conditions of a particular flock, or factors that may indicate a loss of process control.

(d) Establishments operating under the line speed limits authorized in this section shall comply with all other applicable requirements of the laws, including, but not limited to, 29 U.S.C. 654(a).

§ 381.70 Ante mortem inspection; when required; extent.

(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.

§ 381.71 Condemnation on ante mortem inspection.

(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.

§ 381.72 Segregation of suspects on ante mortem inspection.

(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.”

§ 381.73 Quarantine of diseased poultry.

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.

§ 381.74 Poultry suspected of having biological residues.

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.

§ 381.75 Poultry used for research.

(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.

§ 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.

(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.

( 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.

( 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

A Processing Nonconformances

1 Extraneous material ≤ 1 ⁄ 16 ″

—Include any specks, tiny smears, or stains of material that measure 1 ⁄ 16 ″ or less in the greatest dimension.

Examples: Ingesta, unattached feathers, grease, bile remnants, and/or whole gall bladder or spleen, embryonic yolk, etc.

—Factor is one.

—1 to 5 = 1 defect: 6 to 10 = 2 defects; 11 or more = 3 defects. A maximum of three incidents per carcass.

2 Extraneous material > 1 ⁄ 16 ″ to 1″

—The same material as line 1, but measuring > 1 ⁄ 16 ″ to 1″ in the longest dimension.

—Factor is one.

—A maximum of three incidents per carcass.

3 Extraneous material >1″

—The same material as lines 1 to 2, but measuring greater than one inch.

—Factor is two.

—A maximum of two incidents per carcass.

4 Oil glands remnant—less than two whole glands

—Recognizable fragment(s) of one or both oil glands equals one incident.

—Factor is one.

—Maximum of one incident per carcass.

5 Oil glands—two whole glands

—Both whole oil glands with no missing fragments equals one incident. If the oil glands are cut, but no fragment is removed, consider them to be whole. But if even a small fragment is removed, use line 4.

—Factor is two.

—A maximum of one incident per carcass.

6 Lung ≥ 1 ⁄ 4 ″ whole

—Any portion less than a whole lung, and equal to or greater than 1 ⁄ 4 ″ at the greatest dimension, equals one incident.

—Factor is one.

—A maximum of two incidents per carcass.

7 Lung—whole

—Each whole lung equals one incident.

—Factor is two.

—A maximum of two incidents per carcass.

8 Intestine

—Any identifiable portion of the terminal portion of the intestinal tract with a lumen (closed circle) present, or split piece of intestine large enough to be closed to form a lumen.

—Factor is five.

—A maximum of one incident per carcass.

9 Cloaca

—Any identifiable portion of the terminal portion of the intestinal tract with mucosal lining.

—Factor is five.

—A maximum of one incident per carcass.

10 Bursa of Fabricius

—A whole rosebud, or identifiable portion with two or more mucosal folds.

—Factor is two.

—A maximum of one incident per carcass.

11 Esophagus

—Any portion of the esophagus with identifiable mocosal lining.

—Factor is two.

—A maximum of one incident per carcass.

12 Crop—partial—with mucosa

—Any portion of the crop that includes the mucosal lining.

—Factor is two.

—A maximum of one incident per carcass.

13 Crop—whole

—Any complete crop.

—Factor is five.

—A maximum of one incident per carcass.

14 Trachea ≤1″

—Identifiable portion of trachea less than or equal to one inch long.

—Factor is one.

—A maximum of one incident per carcass.

15 Trachea >1″

—Identifiable portion of trachea greater than one inch.

—Factor is two.

—A maximum of one incident per carcass.

16 Hair ≥ 1 ⁄ 4 ″ 26 or more.

—Hair which is one-fourth inch long or longer measured from the top of the follicle to the end of the hair. 26 or more hairs equal one incident.

—Factor is one.

—A maximum of one incident per carcass.

17 Feather and/or Pinfeathers ≤1″

—Attached feathers or protruding pinfeathers less than or equal to one inch long. Scored 5 to 10 per carcass as one incident, 11 to 15 per carcass as two incidents, and 16 or more as three incidents.

—Factor is one.

—A maximum of three incidents per carcass.

18 Feathers >1″

—Attached feathers longer than one inch. Scored 1 to 3 per carcass as one incident 4 to 6 per carcass as two incidents, and 7 or more as three incidents.

—Factor is one.

—A maximum of three incidents per carcass.

19 Long Shank—both condyles covered

—If the complete tibiotarsal joint is covered, it equals one incident.

—Factor is two.

—A maximum of two incidents per carcass.

B Trim nonconformances

1 Breast blister

—Inflammatory tissue, fluid, or pus between the skin and keel must be trimmed if membrane “slips” or if firm nodule is greater than 1 ⁄ 2 ″ in diameter (dime size).

—Factor is two.

—A maximum of one incident per carcass.

2 Breast blister—partially trimmed

—All inflammatory tissue, including that which adheres tightly to the keel bone, must be removed.

—Factor is two.

—A maximum of one incident per carcass.

3 Bruise 1 ⁄ 2 ″ to 1″

—Blood clumps or clots in the superficial layers of tissue, skin, muscle or loose subcutaneous tissue may be slit and the blood completely washed out. When the bruise extends into the deeper layers of muscle, the affected tissue must be removed. Very small bruises less than 1 ⁄ 2 ″ (dime size) and areas showing only slight reddening need not be counted as defects.

—Factor is one.

—A maximum of five incidents per carcass.

4 Bruise >1″

—Same criteria as in line three, but greater than one inch in greatest dimension.

—Factor is two.

—A maximum of three incidents per carcass.

5 Bruise black/green 1 ⁄ 4 ″ to 1″

—Bruises 1 ⁄ 4 ″ to 1″ that have changed from red to a black/blue or green color due to age.

—Factor is two.

—A maximum of three incidents per carcass.

6 Bruise Black/green >1″

—Same as line 5, but measuring greater that 1″ in greatest dimension.

—Factor is five.

—A maximum of two incidents per carcass.

7 Trimmable lesions/Condition

—A trimmable tumor or identifiable portion of a tumor on any part of the carcass.

—Trimmable Synovitis/airsacculitis (saddle/frog) lesions that have not been removed.

—Lesion/condition subject to removal following an approved cleanout process. Examples: airsacculitis, salpingitis, nephritis, spleen, or liver conditions requiring removal of the kidneys.

Note: All establishments shall develop and maintain a permanent marking system that identifies carcasses with removable lesions/conditions on the inside surfaces. When removable lesions/conditions are identified inside the carcass by the inspector, the helper will be notified to apply the permanent mark. When removable inside lesions/conditions are found on a subgroup sample without the permanent mark, the error is not recorded in line 7. The affected carcass(s) will be hungback for IIC disposition and corrective action.

—Factor is five.

—A maximum of one incident per carcass.

8 Failure to complete task as indicated by marking system.

Example: Synovitis, airsacculitis, inflammatory process, contamination, etc.

—The helper, under the inspector's direction, will apply a mark to the carcass, indicating to the trimmer(s) that specific action must be taken on that carcass. When airsac and kidney cleanout, or synovitis part removal, or carcass removal from the line is not completed, or only partially completed, this occurrence is recorded as one defect.

—Factor is five. It will also be recorded as a line 7 defect for a total factor of 10.

—A maximum of one incident per carcass.

9 Compound fracture

—Any bone fracture (i.e., leg or wing) that has caused an opening through the skin. May be accompanied with a bruise, but not always. Do not count the bruise in line 3 or 4 if it is associated with the compound fracture.

—Factor is two.

—A maximum of three incidents per carcass.

10 Wingtip compound fracture

—Same criteria as line 9, but only for wingtips.

Note: Bruises not associated with the fracture should be recorded in the appropriate lines.

—Factor is one.

—A maximum of two incidents per carcass.

11 Untrimmed short hock

—When no cartilage of the hock surface is present and no tendons are attached to the bone.

—Factor is two.

—A maximum of two incidents per carcass.

12 Sores, scabs, inflammatory process, etc. ≤ 1 ⁄ 2 ″

—Any defects such as sores, abscesses, scabs, wounds, dermatitis, inflammatory process, that measure less than or equal to 1 ⁄ 2 ″ in the greatest dimension.

—Factor is two.

—A maximum of two incidents per carcass.

13 Sores, scabs, inflammatory process, etc. > 1 ⁄ 2 ″

—Same as line 12, but greatest dimension is greater than 1 ⁄ 2 ″, or a cluster of smaller lesions in close proximity > 1 ⁄ 2 ″, this category also includes turkey leg edema.

—Factor is five.

—A maximum of one incident per carcass.

14 External mutilation

—Mutilation to the skin and/or muscle that is caused by the slaughter, dressing or eviscerating processes. Skinned elbows (bucked wings) do not trim require unless affected wing joint capsule is also opened.

—Factor is one.

—A maximum of three incidents per carcass.

C Postchill nonconformances—(Designed to monitor those nonconformances added to product during the chilling process)

1 Extraneous material ≤ 1 ⁄ 16 ″

—Include specks, grease, or unidentifiable foreign material that measure 1 ⁄ 16 ″ or less in the greatest dimension.

—Example: Ingesta, grease, or unidentifiable foreign material.

—Factor is one.

—3 to 7 = 1 defect; 8 to 12 = 2 defects; 13 or more = 3 defects. A maximum of three incidents per carcass.

2 Extraneous material > 1 ⁄ 16 ″ to 1″

—This includes ingesta, grease, or unidentifiable foreign material measureing > 1 ⁄ 16 ″ to 1″ longest dimension.

—Factor is one.

—A maximum of three incidents per carcass.

3 Extraneous material >1″

—The same material as line 2, but measuring greater than one inch.

—Factor is two.

—A maximum of two incidents per carcass.

Table 2—Finished Product Standards

SIS

Prechill Processing Nonconformance

Tolerance number (T)

25

Subgroup Absolute Limit (T + 5)

30

Action number

22

Start number

11

Prechill Trim Nonconformance

Tolerance number (T)

12

Subgroup Absolute Limit (T + 5)

17

Action number

15

Start number

8

Postchill Nonconformance

Tolerance number (T)

5

Subgroup Absolute Limit (T + 5)

10

Action number

10

Start number

5

(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.

(Recordkeeping requirements approved by the Office of Management and Budget under control number 0583-0008)

§ 381.77 Carcasses held for further examination.

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.

§ 381.78 Condemnation of carcasses and parts: separation of poultry suspected of containing biological residues.

(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.

§ 381.79 Passing of carcasses and parts.

Each carcass and all organs and other parts of carcasses which are found to be not adulterated shall be passed for human food.

§ 381.80 General; biological residues.

(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.

§ 381.81 Tuberculosis.

Carcasses of poultry affected with tuberculosis shall be condemned.

§ 381.83 Septicemia or toxemia.

Carcasses of poultry showing evidence of any septicemic or toxemic disease, or showing evidence of an abnormal physiologic state, shall be condemned.