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21 U.S.C. § 466 — Imports

Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 466 — Imports

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 unl

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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), Page 733 TITLE 21—FOOD AND DRUGS § 467 Dec. 8, 1993, 107 Stat. 2123; Pub. L. 103–465, title IV, § 431(k), Dec. 8, 1994, 108 Stat. 4969.) Editorial Notes REFERENCES IN TEXT The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (a), 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 1994—Subsec. (d)(1). Pub. L. 103–465, § 431(k)(1), amend- ed par. (1) generally. Prior to amendment, par. (1) read as follows: ‘‘Notwithstanding any other provision of law, except as provided in paragraph (2), all poultry, or parts or products thereof, capable of use as human food offered for importation into the United States shall— ‘‘(A) be subject to the same inspection, sanitary, quality, species verification, and residue standards applied to products produced in the United States; and ‘‘(B) have been processed in facilities and under conditions that are the same as those under which similar products are processed in the United States.’’ Subsec. (d)(2)(A). Pub. L. 103–465, § 431(k)(2)(A), amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows: ‘‘Notwithstanding any other provision of law, all poultry, or parts or products of poultry, capable of use as human food offered for im- portation into the United States from Canada and Mex- ico shall— ‘‘(i) comply with paragraph (1); or ‘‘(ii)(I) be subject to inspection, sanitary, quality, species verification, and residue standards that are equivalent to United States standards; and ‘‘(II) have been processed in facilities and under conditions that meet standards that are equivalent to United States standards.’’ Subsec. (d)(2)(B), (C). Pub. L. 103–465, § 431(k)(2)(B), (C), redesignated subpar. (C) as (B) and struck out former subpar. (B) which read as follows: ‘‘The Sec- retary may treat as equivalent to a United States standard a standard of Canada or Mexico described in subparagraph (A)(ii) if the exporting country provides the Secretary with scientific evidence or other infor- mation, in accordance with risk assessment methodolo- gies agreed to by the Secretary and the exporting coun- try, to demonstrate that the standard of the exporting country achieves the level of protection that the Sec- retary considers appropriate.’’ 1993—Subsec. (d). Pub. L. 103–182, in par. (1), inserted ‘‘except as provided in paragraph (2),’’ before ‘‘all poul- try’’ in introductory provisions, added par. (2), and re- designated former pars. (2) and (3) as (3) and (4), respec- tively. 1985—Par. (d). Pub. L. 99–198 added par. (d). Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1994 AMENDMENT Amendment by Pub. L. 103–465 effective, except as otherwise provided, on the date of entry into force of the World Trade Organization Agreement with respect to the United States (Jan. 1, 1995), see section 451 of Pub. L. 103–465, set out as an Effective Date note under section 3601 of Title 19, Customs Duties. EFFECTIVE DATE OF 1985 AMENDMENT Pub. L. 99–198, title XVII, § 1701(b), Dec. 23, 1985, 99 Stat. 1633, provided that: ‘‘The amendment made by this section [amending this section] shall become effec- tive 6 months after the date of enactment of this Act [Dec. 23, 1985].’’ § 467. Inspection services (a) Refusal or withdrawal; hearing; business unfitness based upon certain convictions; persons responsibly connected with the busi- ness The Secretary may (for such period, or indefi- nitely, as he deems necessary to effectuate the purposes of this chapter) refuse to provide, or withdraw, inspection service under this chapter with respect to any establishment if he deter- mines, after opportunity for a hearing is ac- corded to the applicant for, or recipient of, such service, that such applicant or recipient is unfit to engage in any business requiring inspection upon this chapter because the applicant or re- cipient or anyone responsibly connected with the applicant or recipient, has been convicted, in any Federal or State court, within the pre- vious ten years of (1) any felony or more than one misdemeanor under any law based upon the acquiring, handling, or distributing of adulter- ated, mislabeled, or deceptively packaged food or fraud in connection with transactions in food; or (2) any felony, involving fraud, bribery, extor- tion, or any other act or circumstances indi- cating a lack of the integrity needed for the con- duct of operations affecting the public health. For the purpose of this paragraph a person shall be deemed to be responsibly connected with the business if he was a partner, officer, director, holder, or owner of 10 per centum or more of its voting stock or employee in a managerial or ex- ecutive capacity. (b) Hearing to determine validity of withdrawal or refusal of inspection services; continu- ation of withdrawal or refusal Upon the withdrawal of inspection service from any official establishment for failure to de- stroy condemned poultry products as required under section 455 of this title, or other failure of an official establishment to comply with the re- quirements as to premises, facilities, or equip- ment, or the operation thereof, as provided in section 456 of this title, or the refusal of inspec- tion service to any applicant therefor because of failure to comply with any requirements under section 456 of this title, the applicant for, or re- cipient of, the service shall, upon request, be af- forded opportunity for a hearing with respect to the merits or validity of such action; but such withdrawal or refusal shall continue in effect unless otherwise ordered by the Secretary. (c) Finality and conclusiveness of determination; judicial review; record The determination and order of the Secretary when made after opportunity for hearing, with respect to withdrawal or refusal of inspection service under this chapter shall be final and con- clusive unless the affected applicant for, or re- cipient of, inspection service files application for judicial review within thirty days after the effective date of such order in the United States Court of Appeals as provided in section 457 of this title. Judicial review of any such order shall be upon the record upon which the deter- mination and order are based. The provisions of section 194 of title 7 shall be applicable to ap- peals taken under this section. (Pub. L. 85–172, § 18, Aug. 28, 1957, 71 Stat. 448; Pub. L. 90–492, § 16, Aug. 18, 1968, 82 Stat. 805.)

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 301 — Short title

This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 301 — Short title

Page 30 TITLE 21—FOOD AND DRUGS § 301 Sec. 398. Notices to States regarding imported food. 399. Grants to enhance food safety. 399a. Office of the Chief Scientist. 399b. Office of Women’s Health. 399c. Improving the training of State, local, terri- torial, and tribal food safety officials. 399d. Employee protections. 399e. Nanotechnology. 399f. Ensuring adequate information regarding pharmaceuticals for all populations, par- ticularly underrepresented subpopulations, including racial subgroups. 399g. Food and Drug Administration Intercenter Institutes. 399h. National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufac- turing. 399i. Food and Drug Administration Working Cap- ital Fund. SUBCHAPTER I—SHORT TITLE § 301. Short title This chapter may be cited as the Federal Food, Drug, and Cosmetic Act. (June 25, 1938, ch. 675, § 1, 52 Stat. 1040.) Statutory Notes and Related Subsidiaries EFFECTIVE DATE; POSTPONEMENT IN CERTAIN CASES Act June 23, 1939, ch. 242, §§ 1, 2, 53 Stat. 853, 854, pro- vided that: ‘‘[SEC. 1] (a) The effective date of the following provi- sions of the Federal Food, Drug, and Cosmetic Act is hereby postponed until January 1, 1940: Sections 402(c) [342(c) of this title]; 403(e)(1) [343(e)(1) of this title]; 403(g), (h), (i), (j), and (k) [343(g) to (k) of this title]; 501(a), (4) [351(a)(4) of this title]; 502(b), (d), (e), (f), (g), and (h) [352(b), (d) to (h) of this title]; 601(e) [361(e) of this title]; and 602(b) [362(b) of this title]. ‘‘(b) The Secretary of Agriculture shall promulgate regulations further postponing to July 1, 1940[,] the ef- fective date of the provisions of sections 403(e)(1) [343(e)(1) of this title]; 403(g), (h), (i), (j), and (k) [343(g) to (k)]; 502(b), (d), (

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 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, wholesome, fit for human food, not adulterated, and contain no dye, chemical, preservative, or ingredient which renders them unhealthful, un­wholesome, adulterated, or unfit for human food and unless they also comply with the rules and regulations made by the Secretary of Agriculture to assure that imported poultry or poultry 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 treated as domestic slaughtered poultry, or parts or products thereof, within the meaning and subject to the provisions of this chapter and the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 301](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section301&num=0&edition=prelim) et seq.], and Acts amendatory of, supplemental to, or in substitution for such chapter and Act. **(b) Rules and regulations; destruction and exportation of refused imports** The Secretary of Agriculture is authorized to make rules and regulations to carry out the purposes of this section and in such rules and regulations the Secretary of Agriculture may prescribe the terms and conditions for the destruction of all slaughtered poultry, or parts or products thereof, offered for entry and refused admission into the United States unless such slaughtered poultry, or parts or products thereof, be exported by the consignee within the time fixed therefor in such rules and regulations. **(c) Storage, cartage and labor charges fo

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