21 U.S.C. § 467 — Inspection services

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.) Page 734 TITLE 21—FOOD AND DRUGS § 467a Editorial Notes AMENDMENTS 1968—Par. (a). Pub. L. 90–492 substituted provisions authorizing the Secretary to refuse or withdraw inspec- tion services subsequent to a hearing determining that the applicant or recipient is unfit to engage in any business requiring inspection under this chapter based upon the specified considerations, for provisions grant- ing the Secretary exclusive jurisdiction within the scope of this chapter and exempting poultry and poul- try products from the provisions of the Federal Food, Drug, and Cosmetic Act, as amended, to the extent of the application or the extension thereof of the provi- sions of this chapter. Par. (b). Pub. L. 90–492 substituted provisions grant- ing a hearing, upon request by the applicant or recipi- ent, to determine the merits and validity of the with- drawal or refusal of inspection services and continuing such withdrawal or refusal in effect, unless otherwise ordered by the Secretary, for provisions authorizing the Secretary to cooperate with other branches of gov- ernment and with State agencies and to conduct exami- nations, investigations, and inspections through any officer or employee of a State commissioned by the Secretary for such purpose. Par. (c). Pub. L. 90–492 added par. (c). 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. § 467a. Administrative detention; duration; pend- ing judicial proceedings; notification of gov- ernment authorities; release; removal of offi- cial marks Whenever any poultry product, or any product exempted from the definition of a poultry prod- uct, or any dead, dying, disabled, or diseased poultry is found by any authorized representa- tive of the Secretary upon any premises where it is held for purposes of, or during or after dis- tribution in, commerce or otherwise subject to this chapter, and there is reason to believe that any such article is adulterated or misbranded and is capable of use as human food, or that it has not been inspected, in violation of the provi- sions of this chapter or of any other Federal law or the laws of any State or Territory, or the Dis- trict of Columbia, or that it has been or is in- tended to be, distributed in violation of any such provisions, it may be detained by such rep- resentative for a period not to exceed twenty days, pending action under section 467b of this title or notification of any Federal, State, or other governmental authorities having jurisdic- tion over such article or poultry, and shall not be moved by any person, from the place at which it is located when so detained, until released by such representative. All official marks may be required by such representative to be removed from such article or poultry before it is released unless it appears to the satisfaction of the Sec- retary that the article or poultry is eligible to retain such marks. (Pub. L. 85–172, § 19, as added Pub. L. 90–492, § 17, Aug. 18, 1968, 82 Stat. 805.) § 467b. Seizure and condemnation (a) Proceedings in rem; libel of information; ju- risdiction; disposal by destruction or sale; proceeds into the Treasury; sales restric- tions; bonds; court costs and fees, storage, and other expenses against claimants; jury trial; United States as plaintiff (1) Any poultry product, or any dead, dying, disabled, or diseased poultry, that is being transported in commerce or otherwise subject to this chapter, or is held for sale in the United States after such transportation, and that (A) is or has been processed, sold, transported, or oth- erwise distributed or offered or received for dis- tribution in violation of this chapter, or (B) is capable of use as human food and is adulterated or misbranded, or (C) in any other way is in vio- lation of this chapter, shall be liable to be pro- ceeded against and seized and condemned, at any time, on a libel of information in any United States district court or other proper court as provided in section 467c of this title within the jurisdiction of which the article or poultry is found. (2) If the article or poultry is condemned it shall, after entry of the decree, (A) be distrib- uted in accordance with paragraph (5), or (B) be disposed of by destruction or sale as the court may direct and the proceeds, if sold, less the court costs and fees, and storage and other prop- er expenses, shall be paid into the Treasury of the United States, but the article or poultry shall not be sold contrary to the provisions of this chapter, or the laws of the jurisdiction in which it is sold: Provided, That upon the execu- tion and delivery of a good and sufficient bond conditioned that the article or poultry shall not be sold or otherwise disposed of contrary to the provisions of this chapter, or the laws of the ju- risdiction in which disposal is made, the court may direct that such article or poultry be deliv- ered to the owner thereof subject to such super- vision by authorized representatives of the Sec- retary as is necessary to insure compliance with the applicable laws. (3) When a decree of condemnation is entered against the article or poultry and it is released under bond, or destroyed, court costs and fees, and storage and other proper expenses shall be awarded against the person, if any, intervening as claimant of the article or poultry. (4) The proceedings in such libel cases shall conform, as nearly as may be, to the proceedings in admiralty, except that either party may de- mand trial by jury of any issue of fact joined in any case, and all such proceedings shall be at the suit of and in the name of the United States. (5)(A) An article that is condemned under paragraph (1) may as the court may direct, after entry of the decree, be distributed without charge to nonprofit, private entities or to Fed- eral, State, or local government entities en- gaged in the distribution of food without charge to individuals, if such article— (i) is capable of use as a human food; (ii) has been inspected under this chapter and found to be wholesome and not to be adul- terated within the meaning of paragraphs (1) through (7) of section 453(g) of this title and a determination is made at the time of the