21 U.S.C. § 464 — Exemptions

Page 730 TITLE 21—FOOD AND DRUGS § 464 Editorial Notes AMENDMENTS 1968—Pub. L. 90–492 designated existing provisions as par. (b), added pars. (a) and (c), and in par. (b), as so designated, substituted ‘‘such other rules’’ for ‘‘such rules’’. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1968 AMENDMENT Amendment by Pub. L. 90–492 effective Aug. 18, 1968, see section 20 of Pub. L. 90–492, set out as a note under section 451 of this title. § 464. Exemptions (a) Persons exempted The Secretary shall, by regulation and under such conditions as to sanitary standards, prac- tices, and procedures as he may prescribe, ex- empt from specific provisions of this chapter— (1) retail dealers with respect to poultry products sold directly to consumers in indi- vidual retail stores, if the only processing op- eration performed by such retail dealers is the cutting up of poultry products on the premises where such sales to consumers are made; (2) for such period of time as the Secretary determines that it would be impracticable to provide inspection and the exemption will aid in the effective administration of this chapter, any person engaged in the processing of poul- try or poultry products for commerce and the poultry or poultry products processed by such person: Provided, however, That no such exemp- tion shall continue in effect on and after Janu- ary 1, 1970; and (3) persons slaughtering, processing, or oth- erwise handling poultry or poultry products which have been or are to be processed as re- quired by recognized religious dietary laws, to the extent that the Secretary determines nec- essary to avoid conflict with such require- ments while still effectuating the purposes of this chapter. (b) Territorial exemption The Secretary may, under such sanitary con- ditions as he may by regulations prescribe, ex- empt from the inspection requirements of this chapter the slaughter of poultry, and the proc- essing of poultry products, by any person in any Territory not organized with a legislative body, solely for distribution within such Territory, when the Secretary determines that it is im- practicable to provide such inspection within the limits of funds appropriated for administra- tion of this chapter and that such exemption will aid in the effective administration of this chapter. (c) Personal slaughtering; custom slaughtering; name and address of the poultry producer or processor in lieu of other labeling require- ments; small enterprises; slaughterers or processors of specified number of turkeys; poultry producers raising poultry on own farms (1) The Secretary shall, by regulation and under such conditions, including sanitary stand- ards, practices, and procedures, as he may pre- scribe, exempt from specific provisions of this chapter— (A) the slaughtering by any person of poul- try 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 non- paying guests and employees; (B) 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 mem- bers of his household and his nonpaying guests and 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; (C) the slaughtering and processing of poul- try products in any State or Territory or the District of Columbia by any poultry producer on his own premises with respect to sound and healthy poultry raised on his premises and the distribution by any person solely within such jurisdiction of the poultry products derived from such operations, if, in lieu of other label- ing requirements, such poultry products are identified with the name and address of such poultry producer, and if they are not other- wise misbranded, and are sound, clean, and fit for human food when so distributed; and (D) 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 pro- ducer or other person for distribution by him solely within such jurisdiction directly to household consumers, restaurants, hotels, and boarding houses, for use in their own dining rooms, or in the preparation of meals for sales direct to consumers, if, in lieu of other label- ing requirements, such poultry products are identified with the name and address of the processor, and if they are not otherwise mis- branded and are sound, clean, and fit for human food when distributed by such proc- essor. The exemptions provided for in clauses (C) and (D) above shall not apply if the poultry producer or other person engages in the current calendar year in the business of buying or selling any poultry or poultry products other than as speci- fied in such clauses. (2) In addition to the specific exemptions pro- vided herein, the Secretary shall, when he deter- mines that the protection of consumers from adulterated or misbranded poultry products will not be impaired by such action, provide by regu- lation, consistent with subparagraph (3), for the exemption of the operation and products of small enterprises (including poultry producers), not exempted under subparagraph (1), which are engaged in any State or Territory or the Dis- trict of Columbia in slaughtering and/or cutting up poultry for distribution as carcasses or parts thereof solely for distribution within such juris- diction, from such provisions of this chapter as he deems appropriate, while still protecting the public from adulterated or misbranded products, under such conditions, including sanitary re- quirements, as he shall prescribe to effectuate the purposes of this chapter. Page 731 TITLE 21—FOOD AND DRUGS § 464 (3) No exemption under subparagraph (1)(C) or (D) or subparagraph (2) shall apply to any poul- try producer or other person who, in the current calendar year— (A) slaughters or processes the products of more than 20,000 poultry; or (B) slaughters or processes the products of poultry at a facility used for slaughtering or processing of the products of poultry by any other poultry producer or person. Notwithstanding clause (B), the Secretary may grant such exemption to any poultry producer or other person if the Secretary determines, upon application of such poultry producer or other person, that granting such exemption will not impair effectuating the purposes of this chapter. (4) The provisions of this chapter shall not apply to poultry producers with respect to poul- try of their own raising on their own farms if (i) such producers slaughter not more than 1,000 poultry during the calendar year for which this exemption is being determined; (ii) such poultry producers do not engage in buying or selling poultry products other than those produced from poultry raised on their own farms; and (iii) none of such poultry moves in commerce (as de- fined in section 453(a) of this title). (d) Pizzas containing poultry products (1) Under such terms and conditions as the Secretary shall prescribe through rules and reg- ulations issued under this section that may be necessary to ensure food safety and protect pub- lic health such as special handling procedures, the Secretary shall exempt pizzas containing a poultry product from the inspection require- ments of this chapter if— (A) the poultry product components of the pizzas have been prepared, inspected, and passed in a cured or cooked form as ready-to- eat in compliance with the requirements of this chapter; and (B) the pizzas are to be served in public or private nonprofit institutions. (2) The Secretary may withdraw or modify any exemption under this subsection whenever the Secretary determines such action is necessary to ensure food safety and to protect public health. The Secretary may reinstate or further modify any exemption withdrawn or modified under this subsection. (e) Applicability of adulteration and mis- branding provisions to articles exempted from inspection The adulteration and misbranding provisions of this chapter, other than the requirement of the inspection legend, shall apply to articles which are exempted from inspection under this section, except as otherwise specified under paragraphs (a) and (d). (f) Suspension or termination of exemption The Secretary may by order suspend or termi- nate any exemption under this section with re- spect to any person whenever he finds that such action will aid in effectuating the purposes of this chapter. (Pub. L. 85–172, § 15, Aug. 28, 1957, 71 Stat. 447; Pub. L. 90–492, § 14, Aug. 18, 1968, 82 Stat. 803; Pub. L. 97–206, June 30, 1982, 96 Stat. 136; Pub. L. 102–237, title X, § 1016(b), Dec. 13, 1991, 105 Stat. 1903.) Editorial Notes AMENDMENTS 1991—Subsecs. (d) to (f). Pub. L. 102–237 added subsec. (d), redesignated former subsec. (d) as (e) and sub- stituted ‘‘(d)’’ for ‘‘(c)’’, and redesignated former sub- sec. (e) as (f). 1982—Par. (c)(3). Pub. L. 97–206, § 1, substituted provi- sions that no exemption would be given to persons who during the current calendar year either slaughter or process the products of more than 20,000 poultry, or slaughter or process such poultry at a facility of an- other poultry producer or person, but that, in the latter case, the Secretary may grant the exemption upon ap- plication of such poultry producer or person if granting such exemption would not impair the purposes of this chapter, for provisions that an exemption would not be granted to those who slaughter or process the products of more than 5,000 turkeys or an equivalent number of poultry of all species in the current calendar year (four birds of other species being deemed equivalent of one turkey). Par. (c)(4)(i). Pub. L. 97–206, § 2, substituted ‘‘1,000 poultry during the calendar year for which this exemp- tion is being determined’’ for ‘‘250 turkeys, or not more than an equivalent number of birds of all species during the calendar year for which this exemption is being de- termined (four birds of other species being deemed the equivalent of one turkey)’’. 1968—Par. (a). Pub. L. 90–492, § 14(a), (b), redesignated subpars. (2) to (4) as (1) to (3), respectively, and in sub- par. (2), as so redesignated, substituted ‘‘January 1, 1970’’ for ‘‘July 1, 1960’’. Former subpar. (1), which ex- empted poultry producers with respect to poultry of their own raising on their own farms which they sold directly to household consumers, hotels, etc., for use in their own dining rooms or in the preparation of meals for sales direct to consumers only, provided that such producers did not engage in buying or selling poultry products other than those produced from poultry raised on their own farms, was struck out. Pars. (b) to (e). Pub. L. 90–492, § 14(c), added pars. (b) to (d) and redesignated former par. (b) as (e). Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1968 AMENDMENT Amendment by Pub. L. 90–492 effective upon the expi- ration of sixty days after Aug. 18, 1968, see section 20(b) of Pub. L. 90–492, set out as a note under section 451 of this title. REGULATIONS Pub. L. 102–237, title X, § 1016(c), Dec. 13, 1991, 105 Stat. 1903, provided that: ‘‘No later than August 1, 1992, the Secretary of Agriculture shall issue final rules, through prior notice and comment rulemaking procedures, to implement the exemption authorized by section 23(c) of the Federal Meat Inspection Act [21 U.S.C. 623(c)] (as added by subsection (a)) and the exemption authorized by section 15(d) of the Poultry Products Inspection Act [21 U.S.C. 464(d)] (as added by subsection (b)). Prior to the issuance of the final rules, the Secretary shall hold at least one public hearing examining the public health and food safety issues raised by the granting of each of the exemptions.’’ STUDIES CONCERNING GRANT OF FUTURE EXEMPTIONS FOR POULTRY AND MEAT FOOD PRODUCTS Pub. L. 102–237, title X, § 1016(d), Dec. 13, 1991, 105 Stat. 1903, directed Secretary of Agriculture in con- sultation with National Academy of Sciences to con- duct a study on meat food and poultry products inspec- tion exemptions under Federal Meat Inspection Act and Page 732 TITLE 21—FOOD AND DRUGS § 465 Poultry Products Inspection Act and a study on an ex- emption from requirements of such Acts for certain wholesale meat outlets selling to hotels and other simi- lar institutional users not later than 24 months after Dec. 13, 1991, and on completion of each study to pro- vide the results to Committee on Agriculture of House of Representatives and Committee on Agriculture, Nu- trition, and Forestry of Senate. § 465. Limitations upon entry of poultry products and other materials into official establish- ments The Secretary may limit the entry of poultry products and other materials into any official establishment, under such conditions as he may prescribe to assure that allowing the entry of such articles into such inspected establishments will be consistent with the purposes of this chapter. (Pub. L. 85–172, § 16, Aug. 28, 1957, 71 Stat. 448; Pub. L. 90–492, § 15, Aug. 18, 1968, 82 Stat. 805.) Editorial Notes AMENDMENTS 1968—Pub. L. 90–492 substituted provisions author- izing the Secretary to limit the entry of poultry prod- ucts and other materials into any official establish- ment for provisions that any person distributing un- wholesome or adulterated exempted poultry or poultry products intended for human consumption shall be guilty of a misdemeanor and subject to penalties upon conviction thereof. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1968 AMENDMENT Amendment by Pub. L. 90–492 effective Aug. 18, 1968, see section 20 of Pub. L. 90–492, set out as a note under section 451 of this title. § 466. Imports (a) Compliance with standards and regulations; status after importation No slaughtered poultry, or parts or products thereof, of any kind shall be imported into the United States unless they are healthful, whole- some, fit for human food, not adulterated, and contain no dye, chemical, preservative, or ingre- dient which renders them unhealthful, un- wholesome, adulterated, or unfit for human food and unless they also comply with the rules and regulations made by the Secretary of Agri- culture to assure that imported poultry or poul- try products comply with the standards provided for in this chapter. All imported, slaughtered poultry, or parts or products thereof, shall after entry into the United States in compliance with such rules and regulations be deemed and treat- ed as domestic slaughtered poultry, or parts or products thereof, within the meaning and sub- ject to the provisions of this chapter and the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], and Acts amendatory of, supple- mental to, or in substitution for such chapter and Act. (b) Rules and regulations; destruction and expor- tation of refused imports The Secretary of Agriculture is authorized to make rules and regulations to carry out the pur- poses of this section and in such rules and regu- lations the Secretary of Agriculture may pre- scribe the terms and conditions for the destruc- tion of all slaughtered poultry, or parts or prod- ucts thereof, offered for entry and refused ad- mission into the United States unless such slaughtered poultry, or parts or products there- of, be exported by the consignee within the time fixed therefor in such rules and regulations. (c) Storage, cartage and labor charges for im- ports refused admission All charges for storage, cartage, and labor with respect to any product which is refused ad- mission pursuant to this section shall be paid by the owner or consignee, and in default of such payment shall constitute a lien against any other products imported thereafter by or for such owner or consignee. (d) Domestic standards and processing facilities applicable; enforcement (1) Notwithstanding any other provision of law, all poultry, or parts or products of poultry, capable of use as human food offered for impor- tation into the United States shall— (A) be subject to inspection, sanitary, qual- ity, species verification, and residue standards that achieve a level of sanitary protection equivalent to that achieved under United States standards; and (B) have been processed in facilities and under conditions that achieve a level of sani- tary protection equivalent to that achieved under United States standards. (2)(A) The Secretary may treat as equivalent to a United States standard a standard of an ex- porting country described in paragraph (1) if the exporting country provides the Secretary with scientific evidence or other information, in ac- cordance with risk assessment methodologies determined appropriate by the Secretary, to demonstrate that the standard of the exporting country achieves the level of sanitary protec- tion achieved under the United States standard. For the purposes of this subsection, the term ‘‘sanitary protection’’ means protection to safe- guard public health. (B) The Secretary may— (i) determine, on a scientific basis, that the standard of the exporting country does not achieve the level of protection that the Sec- retary considers appropriate; and (ii) provide the basis for the determination in writing to the exporting country on re- quest. (3) Any such imported poultry article that does not meet such standards shall not be per- mitted entry into the United States. (4) The Secretary shall enforce this subsection through— (A) random inspections for such species verification and for residues; and (B) random sampling and testing of internal organs and fat of carcasses for residues at the point of slaughter by the exporting country, in accordance with methods approved by the Sec- retary. (Pub. L. 85–172, § 17, Aug. 28, 1957, 71 Stat. 448; Pub. L. 99–198, title XVII, § 1701(a), Dec. 23, 1985, 99 Stat. 1633; Pub. L. 103–182, title III, § 361(e),