21 U.S.C. § 454 — Federal and State cooperation in develop-

Page 722 TITLE 21—FOOD AND DRUGS § 454 (v) The term ‘‘capable of use as human food’’ shall apply to any carcass, or part or product of a carcass, of any poultry, unless it is denatured or otherwise identified as required by regula- tions prescribed by the Secretary to deter its use as human food, or it is naturally inedible by humans. (w) The term ‘‘processed’’ means slaughtered, canned, salted, stuffed, rendered, boned, cut up, or otherwise manufactured or processed. (x) The term ‘‘Federal Food, Drug, and Cos- metic Act’’ means the Act so entitled, approved June 25, 1938 (52 Stat. 1040) [21 U.S.C. 301 et seq.], and Acts amendatory thereof or supplementary thereto. (y) The terms ‘‘pesticide chemical’’, ‘‘food ad- ditive’’, ‘‘color additive’’, and ‘‘raw agricultural commodity’’ shall have the same meanings for purposes of this chapter as under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.]. (z) The term ‘‘poultry products broker’’ means any person engaged in the business of buying or selling poultry products on commission, or oth- erwise negotiating purchases or sales of such ar- ticles other than for his own account or as an employee of another person. (aa) The term ‘‘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 under this chapter. (bb) The term ‘‘animal food manufacturer’’ means any person engaged in the business of manufacturing or processing animal food de- rived wholly or in part from carcasses, or parts or products of the carcasses, of poultry. (Pub. L. 85–172, § 4, Aug. 28, 1957, 71 Stat. 441; Pub. L. 87–498, June 25, 1962, 76 Stat. 110; Pub. L. 90–492, § 4, Aug. 18, 1968, 82 Stat. 792; Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 102–571, title I, § 107(13), Oct. 29, 1992, 106 Stat. 4499.) Editorial Notes REFERENCES IN TEXT The Federal Food, Drug, and Cosmetic Act, referred to in pars. (x) and (y), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§ 301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables. AMENDMENTS 1992—Subsec. (g)(2)(D). Pub. L. 102–571 substituted ‘‘379e’’ for ‘‘376’’. 1968—Pub. L. 90–492 inserted definitions of ‘‘State’’, ‘‘territory’’, ‘‘United States’’, ‘‘misbranded’’, ‘‘official mark’’, ‘‘official inspection legend’’, ‘‘official certifi- cate’’, ‘‘official device’’, ‘‘capable of use as human food’’, ‘‘processed’’, ‘‘Federal Food, Drug, and Cosmetic Act’’, ‘‘pesticide chemical’’, ‘‘poultry products broker’’, ‘‘renderer’’, and ‘‘animal food manufacturer’’, revised definitions of ‘‘commerce’’, ‘‘poultry’’, ‘‘poultry prod- uct’’, ‘‘adulterated’’, ‘‘Secretary’’, ‘‘inspector’’, ‘‘con- tainer’’ or ‘‘package’’, ‘‘label’’, and ‘‘immediate con- tainer’’, reenacted without change definitions of ‘‘per- son’’, ‘‘official establishment’’, ‘‘inspection service’’, and ‘‘shipping container’’, and deleted definition of ‘‘wholesome’’, ‘‘unwholesome’’, and ‘‘official inspection mark’’. 1962—Par. (a). Pub. L. 87–498 struck out references to Territories or possessions, and inserted definition of ‘‘State’’. Statutory Notes and Related Subsidiaries CHANGE OF NAME ‘‘Secretary of Health and Human Services’’ sub- stituted for ‘‘Secretary of Health, Education, and Wel- fare’’ in par. (h)(10) pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education. 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. § 454. Federal and State cooperation in develop- ment and administration of State poultry product inspection programs (a) State laws; planning, technical and financial assistance; advisory committees It is the policy of the Congress to protect the consuming public from poultry products that are adulterated or misbranded and to assist in efforts by State and other government agencies to accomplish this objective. In furtherance of this policy— (1) The Secretary is authorized, whenever he determines that it would effectuate the pur- poses of this chapter, to cooperate with the ap- propriate State agency in developing and ad- ministering a State poultry product inspec- tion program in any State which has enacted a mandatory State poultry product inspection law that imposes ante mortem and post mortem inspection, reinspection and sanita- tion requirements that are at least equal to those under this chapter, with respect to all or certain classes of persons engaged in the State in slaughtering poultry or processing poultry products for use as human food solely for dis- tribution within such State. (2) The Secretary is further authorized, whenever he determines that it would effec- tuate the purposes of this chapter, to cooper- ate with appropriate State agencies in devel- oping and administering State programs under State laws containing authorities at least equal to those provided in section 460 of this title; and to cooperate with other agencies of the United States in carrying out any provi- sions of this chapter. In carrying out the pro- visions of this chapter, the Secretary may conduct such examinations, investigations, and inspections as he determines practicable through any officer or employee of any State or Territory or the District of Columbia com- missioned by the Secretary for such purpose. (3) Cooperation with State agencies under this section may include furnishing to the ap- propriate State agency (i) advisory assistance in planning and otherwise developing an ade- quate State program under the State law; and (ii) technical and laboratory assistance and training (including necessary curricular and instructional materials and equipment), and financial and other aid for administration of such a program. The amount to be contributed to any State by the Secretary under this sec- tion from Federal funds for any year shall not exceed 50 per centum of the estimated total cost of the cooperative program; and the Fed- eral funds shall be allocated among the States Page 723 TITLE 21—FOOD AND DRUGS § 454 desiring to cooperate on an equitable basis. Such cooperation and payment shall be con- tingent at all times upon the administration of the State program in a manner which the Secretary, in consultation with the appro- priate advisory committee appointed under subparagraph (4), deems adequate to effectuate the purposes of this section. (4) The Secretary may appoint advisory committees consisting of such representatives of appropriate State agencies as the Secretary and the State agencies may designate to con- sult with him concerning State and Federal programs with respect to poultry product in- spection and other matters within the scope of this chapter, including evaluating State pro- grams for purposes of this chapter, and obtain- ing better coordination and more uniformity among the State programs and between the Federal and State programs and adequate pro- tection of consumers. (b) Appropriate State agency; performance of functions by subordinate governmental unit The appropriate State agency with which the Secretary may cooperate under this chapter shall be a single agency in the State which is primarily responsible for the coordination of the State programs having objectives similar to those under this chapter. When the State pro- gram includes performance of certain functions by a municipality or other subordinate govern- mental unit, such unit shall be deemed to be a part of the State agency for purposes of this sec- tion. (c) Intrastate activities; designation of State for regulation; publication of designation; ex- empted operations; termination of designa- tion; review of operations in nondesignated States; annual report (1) If the Secretary has reason to believe, by thirty days prior to the expiration of two years after August 18, 1968, that a State has failed to develop or is not enforcing, with respect to all establishments within its jurisdiction (except those that would be exempted from Federal in- spection under subparagraph (2) of this para- graph (c)) at which poultry are slaughtered, or poultry products are processed for use as human food, solely for distribution within such State, and the products of such establishments, re- quirements at least equal to those imposed under sections 451 to 453, 455 to 459, 461 to 467d of this title, he shall promptly notify the Gov- ernor of the State of this fact. If the Secretary determines, after consultation with the Gov- ernor of the State, or representative selected by him, that such requirements have not been de- veloped and activated, he shall promptly after the expiration of such two-year period designate such State as one in which the provisions of said sections of this chapter shall apply to oper- ations and transactions wholly within such State: Provided, That if the Secretary has reason to believe that the State will activate such re- quirements within one additional year, he may delay such designation for said period, and not designate the State, if he determines at the end of the year that the State then has such require- ments in effective operation. The Secretary shall publish any such designation in the Fed- eral Register and, upon the expiration of thirty days after such publication, the provisions of said sections of this chapter shall apply to oper- ations and transactions and to persons engaged therein in the State to the same extent and in the same manner as if such operations and transactions were conducted in or for commerce. However, notwithstanding any other provision of this section, if the Secretary determines that any establishment within a State is producing adulterated poultry products for distribution within such State which would clearly endanger the public health he shall notify the Governor of the State and the appropriate advisory com- mittee provided for by subparagraph (a)(4) of this section of such fact for effective action under State or local law. If the State does not take action to prevent such endangering of the public health within a reasonable time after such notice, as determined by the Secretary, in light of the risk to public health, the Secretary may forthwith designate any such establish- ment as subject to the provisions of said sec- tions of this chapter, and thereupon the estab- lishment and operator thereof shall be subject to such provisions as though engaged in com- merce until such time as the Secretary deter- mines that such State has developed and will en- force requirements at least equal to those im- posed under said sections. (2) The provisions of this chapter requiring in- spection of the slaughter of poultry and the processing of poultry products shall 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 nor- mal retail quantities or service of such articles to consumers at such establishments if such es- tablishments are subject to such inspection pro- visions only under this paragraph (c). For the purposes of this subparagraph, operations con- ducted at a restaurant central kitchen facility shall be considered as being conducted at a res- taurant if the restaurant central kitchen pre- pares poultry products that are ready to eat when they leave such facility and are served in meals or as entrees only to customers at res- taurants owned or operated by the same person owning or operating such facility: Provided, That such facility shall be subject to the provi- sions of section 460(b) of this title: Provided fur- ther, That the facility may be subject to the in- spection requirements of this chapter for as long as the Secretary deems necessary, if the Sec- retary determines that the sanitary conditions or practices of the facility or the processing pro- cedures or methods at the facility are such that any of its poultry products are rendered adulter- ated. (3) Whenever the Secretary determines that any State designated under this paragraph (c) has developed and will enforce State poultry products inspection requirements at least equal to those imposed under the aforesaid sections of this chapter, with respect to the operations and transactions within such State which are regu- lated under subparagraph (1) of this paragraph (c), he shall terminate the designation of such State under this paragraph (c), but this shall not preclude the subsequent redesignation of the Page 724 TITLE 21—FOOD AND DRUGS § 455 1 See References in Text note below. State at any time upon thirty days’ notice to the Governor and publication in the Federal Register in accordance with this paragraph, and any State may be designated upon such notice and publication, at any time after the period specified in this paragraph whether or not the State has theretofore been designated, upon the Secretary determining that it is not effectively enforcing requirements at least equal to those imposed under said sections. (4) The Secretary shall promptly upon August 18, 1968, and periodically thereafter, but at least annually, review the requirements, including the enforcement thereof, of the several States not designated under this paragraph (c), with re- spect to the slaughter, and the processing, stor- age, handling, and distribution of poultry prod- ucts, and inspection of such operations, and an- nually report thereon to the Committee on Agri- culture of the House of Representatives and the Committee on Agriculture, Nutrition, and For- estry of the Senate in the report required in sec- tion 470 1 of this title. (d) ‘‘State’’ defined As used in this section, the term ‘‘State’’ means any State (including the Commonwealth of Puerto Rico) or organized territory. (Pub. L. 85–172, § 5, Aug. 28, 1957, 71 Stat. 443; Pub. L. 90–492, § 5, Aug. 18, 1968, 82 Stat. 796; Pub. L. 98–487, § 2, Oct. 17, 1984, 98 Stat. 2264; Pub. L. 103–437, § 8(1), Nov. 2, 1994, 108 Stat. 4588.) Editorial Notes REFERENCES IN TEXT Section 470 of this title, referred to in subsec. (c)(4), was omitted from the Code. CODIFICATION In par. (c)(1), (4), ‘‘August 18, 1968’’ substituted for ‘‘enactment of the Wholesome Poultry Products Act’’. AMENDMENTS 1994—Subsec. (c)(4). Pub. L. 103–437 substituted ‘‘Agri- culture, Nutrition, and Forestry’’ for ‘‘Agriculture and Forestry’’. 1984—Par. (c)(2). Pub. L. 98–487 inserted provisions re- lating to operations conducted at a restaurant central kitchen facility. 1968—Pub. L. 90–492 substituted provisions author- izing the Secretary to cooperate with the appropriate state agency in the development and administration of state poultry product inspection programs in those states having mandatory poultry product inspection laws and those states having laws at least equal to the provisions of section 460 of this title, provisions author- izing planning, technical and financial assistance and the appointment of advisory committees, provisions designating the appropriate state agency with which the Secretary may cooperate, provisions authorizing the Secretary to designate states as subject to the reg- ulatory provisions of this chapter when the require- ments of the specified section have not been complied with or when the specified intrastate activities are present, provisions exempting from the requirements of this chapter operations of the types traditionally and usually conducted at retail stores and restaurants, pro- visions authorizing the Secretary to terminate the aforementioned designation of states as subject to the regulatory provisions of this chapter, and provisions authorizing the Secretary to review the operations in nondesignated states and make an annual report there- on, for provisions authorizing the Secretary, upon ap- plication by any appropriate state or local official or agency or by any appropriate local poultry industry group and after public hearing, to designate major con- suming areas as subject to the regulatory provisions of this chapter where the Secretary finds that poultry or poultry products are handled or consumed in such vol- ume as to affect, burden or obstruct the movement of inspected poultry products in interstate commerce. 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. § 455. Inspection in official establishments (a) Ante mortem inspection For the purpose of preventing the entry into or flow or movement in commerce of, or the bur- dening of commerce by, any poultry product which is capable of use as human food and is adulterated, the Secretary shall, where and to the extent considered by him necessary, cause to be made by inspectors ante mortem inspec- tion of poultry in each official establishment processing poultry or poultry products for com- merce or otherwise subject to inspection under this chapter. (b) Post mortem inspection; quarantine, segrega- tion, and reinspection The Secretary, whenever processing oper- ations are being conducted, shall cause to be made by inspectors post mortem inspection of the carcass of each bird processed, and at any time such quarantine, segregation, and reinspec- tion as he deems necessary of poultry and poul- try products capable of use as human food in each official establishment processing such poultry or poultry products for commerce or otherwise subject to inspection under this chap- ter. (c) Condemnation; appeal; reprocessing All poultry carcasses and parts thereof and other poultry products found to be adulterated shall be condemned and shall, if no appeal be taken from such determination of condemna- tion, be destroyed for human food purposes under the supervision of an inspector: Provided, That carcasses, parts, and products, which may by reprocessing be made not adulterated, need not be so condemned and destroyed if so reproc- essed under the supervision of an inspector and thereafter found to be not adulterated. If an ap- peal be taken from such determination, the car- casses, parts, or products shall be appropriately marked and segregated pending completion of an appeal inspection, which appeal shall be at the cost of the appellant if the Secretary deter- mines that the appeal is frivolous. If the deter- mination of condemnation is sustained the car- casses, parts, and products shall be destroyed for human food purposes under the supervision of an inspector. (Pub. L. 85–172, § 6, Aug. 28, 1957, 71 Stat. 443; Pub. L. 90–492, § 6, Aug. 18, 1968, 82 Stat. 798.)