21 U.S.C. § 460 — Miscellaneous activities subject to regula-

Page 727 TITLE 21—FOOD AND DRUGS § 460 (1) forge any official device, mark, or certifi- cate; (2) without authorization from the Secretary use any official device, mark, or certificate, or simulation thereof, or alter, detach, deface, or destroy any official device, mark, or certifi- cate; (3) contrary to the regulations prescribed by the Secretary, fail to use, or to detach, deface, or destroy any official device, mark, or certifi- cate; (4) knowingly possess, without promptly no- tifying the Secretary or his representative, any official device or any counterfeit, simu- lated, forged, or improperly altered official certificate or any device or label or any car- cass of any poultry, or part or product thereof, bearing any counterfeit, simulated, forged, or improperly altered official mark; (5) knowingly make any false statement in any shipper’s certificate or other nonofficial or official certificate provided for in the regu- lations prescribed by the Secretary; or (6) knowingly represent that any article has been inspected and passed, or exempted, under this chapter when, in fact, it has respectively, not been so inspected and passed, or exempted. (Pub. L. 85–172, § 9, Aug. 28, 1957, 71 Stat. 445; Pub. L. 90–492, § 9, Aug. 18, 1968, 82 Stat. 800.) Editorial Notes AMENDMENTS 1968—Pub. L. 90–492 made revisions in form and phra- seology, added to the enumerated prohibited acts slaughtering poultry or processing any poultry prod- ucts capable of use as human food, except in compli- ance with the requirements of this chapter, selling and transporting adulterated or misbranded poultry prod- ucts or uninspected poultry products, adulterating or misbranding poultry products while they are being transported in commerce or held for sale after such transportation, treating carcasses not in accordance with regulations promulgated by the Secretary, pos- sessing, without notifying the Secretary, any official device or any counterfeit, simulated, etc., official cer- tificate, or any device or label bearing any counterfeit, simulated, etc., official mark, and making false rep- resentations and statements, and clarified application to brand manufacturers and printers of existing provi- sions prohibiting the counterfeiting of official marks, labels, or certificates. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1968 AMENDMENT Amendment by Pub. L. 90–492 effective Aug. 18, 1968, except that amendment of pars. (a)(2)(A) and (a)(3) ef- fective upon the expiration of sixty days after Aug. 18, 1968, see section 20 of Pub. L. 90–492, set out as a note under section 451 of this title. § 459. Compliance by all establishments (a) In general No establishment processing poultry or poul- try products for commerce otherwise subject to this chapter shall process any poultry or poultry product except in compliance with the require- ments of this chapter. (b) Notification Any establishment subject to inspection under this chapter that believes, or has reason to be- lieve, that an adulterated or misbranded poultry or poultry product received by or originating from the establishment has entered into com- merce shall promptly notify the Secretary with regard to the type, amount, origin, and destina- tion of the poultry or poultry product. (c) Plans and reassessments The Secretary shall require that each estab- lishment subject to inspection under this chap- ter shall, at a minimum— (1) prepare and maintain current procedures for the recall of all poultry or poultry prod- ucts produced and shipped by the establish- ment; (2) document each reassessment of the proc- ess control plans of the establishment; and (3) upon request, make the procedures and reassessed process control plans available to inspectors appointed by the Secretary for re- view and copying. (Pub. L. 85–172, § 10, Aug. 28, 1957, 71 Stat. 446; Pub. L. 90–492, § 10, Aug. 18, 1968, 82 Stat. 801; Pub. L. 110–234, title XI, § 11017(b), May 22, 2008, 122 Stat. 1370; Pub. L. 110–246, § 4(a), title XI, § 11017(b), June 18, 2008, 122 Stat. 1664, 2132.) Editorial Notes CODIFICATION Pub. L. 110–234 and Pub. L. 110–246 made identical amendments to this section. The amendments by Pub. L. 110–234 were repealed by section 4(a) of Pub. L. 110–246. AMENDMENTS 2008—Pub. L. 110–246, § 11017(b), inserted section catch- line, designated existing provisions as subsec. (a), in- serted heading, and added subsecs. (b) and (c). 1968—Pub. L. 90–492 substituted ‘‘otherwise subject to this chapter’’ for ‘‘in or for marketing in a designated major consuming area’’. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2008 AMENDMENT Amendment of this section and repeal of Pub. L. 110–234 by Pub. L. 110–246 effective May 22, 2008, the date of enactment of Pub. L. 110–234, see section 4 of Pub. L. 110–246, set out as an Effective Date note under section 8701 of Title 7, Agriculture. 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. § 460. Miscellaneous activities subject to regula- tion (a) Prohibition of inspection of articles not in- tended for use as human food; denaturation or other identification prior to distribution in commerce; inedible articles Inspection shall not be provided under this chapter at any establishment for the slaughter of poultry or the processing of any carcasses or parts or products of poultry, which are not in- tended for use as human food, but such articles shall, prior to their offer for sale or transpor- tation in commerce, unless naturally inedible by humans, be denatured or otherwise identified as prescribed by regulations of the Secretary to Page 728 TITLE 21—FOOD AND DRUGS § 460 deter their use for human food. No person shall buy, sell, transport, or offer for sale or transpor- tation, or receive for transportation, in com- merce, or import, any poultry carcasses or parts or products thereof which are not intended for use as human food unless they are denatured or otherwise identified as required by the regula- tions of the Secretary or are naturally inedible by humans. (b) Recordkeeping requirements; persons liable; scope of disclosure; access to places of busi- ness; examination of records, facilities, and inventories; copies; samples The following classes of persons shall, for such period of time as the Secretary may by regula- tions prescribe, not to exceed two years unless otherwise directed by the Secretary for good cause shown, keep such records as are properly necessary for the effective enforcement of this chapter in order to insure against adulterated or misbranded poultry products for the American consumer; and all persons subject to such re- quirements shall, at all reasonable times, upon notice by a duly authorized representative of the Secretary, afford such representative access to their places of business and opportunity to examine the facilities, inventory, and records thereof, to copy all such records, and to take reasonable samples of their inventory upon pay- ment of the fair market value therefor— (1) Any person that engages in the business of slaughtering any poultry or processing, freezing, packaging, or labeling any carcasses, or parts or products of carcasses, of any poul- try, for commerce, for use as human food or animal food; (2) Any person that engages in the business of buying or selling (as poultry products bro- kers, wholesalers or otherwise), or trans- porting, in commerce, or storing in or for com- merce, or importing, any carcasses, or parts or products of carcasses, of any poultry; (3) Any person that engages in business, in or for commerce, as a renderer, or engages in the business of buying, selling, or trans- porting, in commerce, or importing, any dead, dying, disabled, or diseased poultry or parts of the carcasses of any poultry that died other- wise than by slaughter. (c) Registration of business, name of person, and trade names No person shall engage in business, in or for commerce, as a poultry products broker, ren- derer, or animal food manufacturer, or engage in business in commerce as a wholesaler of any carcasses, or parts or products of the carcasses, of any poultry, whether intended for human food or other purposes, or engage in business as a public warehouseman storing any such articles in or for commerce, or engage in the business of buying, selling, or transporting in commerce, or importing, any dead, dying, disabled, or diseased poultry, or parts of the carcasses of any poultry that died otherwise than by slaughter, unless when required by regulations of the Secretary, he has registered with the Secretary his name, and the address of each place of business at which, and all trade names under which, he con- ducts such business. (d) Regulation of transactions, transportation, or importation of dead, dying, disabled or dis- eased poultry or carcasses to prevent use as human food No person engaged in the business of buying, selling, or transporting in commerce, or import- ing, dead, dying, disabled, or diseased poultry, or any parts of the carcasses of any poultry that died otherwise than by slaughter, shall buy, sell, transport, offer for sale or transportation, or re- ceive for transportation, in commerce, or im- port, any dead, dying, disabled, or diseased poul- try or parts of the carcasses of any poultry that died otherwise than by slaughter, unless such transaction, transportation or importation is made in accordance with such regulations as the Secretary may prescribe to assure that such poultry, or the unwholesome parts or products thereof, will be prevented from being used for human food. (e) Federal provisions applicable to State or Ter- ritorial business transactions of a local na- ture and not subject to local authority The authority conferred on the Secretary by paragraph (b), (c), or (d) of this section with re- spect to persons engaged in the specified kinds of business in or for commerce may be exercised with respect to persons engaged, in any State or organized territory, in such kinds of business but not in or for commerce, whenever the Sec- retary determines, after consultation with an appropriate advisory committee provided for in section 454 of this title, that the State or terri- tory does not have at least equal authority under its laws or such authority is not exercised in a manner to effectuate the purposes of this chapter, including the State or territory pro- viding for the Secretary or his representative being afforded access to such places of business and the facilities, inventories, and records thereof, and the taking of reasonable samples, where he determines necessary in carrying out his responsibilities under this chapter; and in such case the provisions of paragraph (b), (c), or (d) of this section, respectively, shall apply to such persons to the same extent and in the same manner as if they were engaged in such business in or for commerce and the transactions in- volved were in commerce. (Pub. L. 85–172, § 11, Aug. 28, 1957, 71 Stat. 446; Pub. L. 90–492, § 11, Aug. 18, 1968, 82 Stat. 801.) Editorial Notes AMENDMENTS 1968—Pub. L. 90–492 designated existing provisions as par. (b), added pars. (a), and (c) to (e), and in par. (b), as so designated, extended the types of persons required to maintain records necessary for the enforcement of this chapter, required such persons to give representa- tives of the Secretary access to their places of business, and opportunity to examine records, facilities, and in- ventories and to copy records and take inventory sam- ples upon payment. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1968 AMENDMENT Amendment by Pub. L. 90–492 effective Aug. 18, 1968, except that par. (d) effective upon the expiration of sixty days after Aug. 18, 1968, see section 20 of Pub. L. 90–492, set out as a note under section 451 of this title. Page 729 TITLE 21—FOOD AND DRUGS § 463 § 461. Offenses and punishment (a) Violations; liability of agents, employees, and employers Any person who violates the provisions of sec- tion 458, 459, 460, 463, or 466 of this title shall be fined not more than $1,000 or imprisoned not more than one year, or both; but if such viola- tion involves intent to defraud, or any distribu- tion or attempted distribution of an article that is adulterated (except as defined in section 453(g)(8) of this title), such person shall be fined not more than $10,000 or imprisoned not more than three years, or both. When construing or enforcing the provisions of said sections the act, omission, or failure of any person acting for or employed by any individual, partnership, cor- poration, or association within the scope of his employment or office shall in every case be deemed the act, omission, or failure of such indi- vidual, partnership, corporation, or association, as well as of such person. (b) Liability of carrier No carrier shall be subject to the penalties of this chapter, other than the penalties for viola- tion of section 460 of this title, by reason of his receipt, carriage, holding, or delivery, in the usual course of business, as a carrier, of poultry or poultry products, owned by another person unless the carrier has knowledge, or is in posses- sion of facts which would cause a reasonable person to believe that such poultry or poultry products were not inspected or marked in ac- cordance with the provisions of this chapter or were otherwise not eligible for transportation under this chapter or unless the carrier refuses to furnish on request of a representative of the Secretary the name and address of the person from whom he received such poultry or poultry products, and copies of all documents, if any there be, pertaining to the delivery of the poul- try or poultry products to such carrier. (c) Assaulting, resisting, or impeding certain per- sons; murder; punishments Any person who forcibly assaults, resists, op- poses, impedes, intimidates, or interferes with any person while engaged in or on account of the performance of his official duties under this chapter shall be fined not more than $5,000 or imprisoned not more than three years, or both. Whoever, in the commission of any such acts, uses a deadly or dangerous weapon, shall be fined not more than $10,000 or imprisoned not more than ten years, or both. Whoever kills any person while engaged in or on account of the performance of his official duties under this chapter shall be punished as provided under sec- tions 1111 and 1114 of title 18. (Pub. L. 85–172, § 12, Aug. 28, 1957, 71 Stat. 446; Pub. L. 90–492, § 12, Aug. 18, 1968, 82 Stat. 802.) Editorial Notes AMENDMENTS 1968—Par. (a). Pub. L. 90–492, § 12(a), inserted ref- erence to violations of section 463 of this title, and sub- stituted provisions that violators of the enumerated sections shall be fined not more than $1,000 or impris- oned not more than one year, or both, but that in cases involving intent to defraud, or any distribution or at- tempt to distribute adulterated articles, except as de- fined in section 453(g) of this title, the violators shall be fined not more than $10,000 or imprisoned not more than three years, or both, for provisions that violators shall be guilty of a misdemeanor and subject to impris- onment for not more than six months or a fine of not more than $3,000, or both, with increased fines and im- prisonment for any subsequent violations. Par. (b). Pub. L. 90–492, § 12(b), substituted ‘‘of poul- try’’ for ‘‘of slaughtered poultry’’, ‘‘such poultry’’ for ‘‘such slaughtered poultry’’, and ‘‘otherwise not eligi- ble’’ for ‘‘not otherwise eligible’’, and inserted provi- sion that no carrier shall be subject to punishment un- less the carrier refuses to furnish the name and address of the person from whom he received such poultry or poultry products, and copies of any documents per- taining to the delivery of the poultry or poultry prod- ucts to such carrier. Par. (c). Pub. L. 90–492, § 12(c), 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. § 462. Reporting of violations; notice; opportunity to present views Before any violation of this chapter is re- ported by the Secretary to any United States at- torney for institution of a criminal proceeding, the person against whom such proceeding is con- templated shall be given reasonable notice of the alleged violation and opportunity to present his views orally or in writing with regard to such contemplated proceeding. Nothing in this chapter shall be construed as requiring the Sec- retary to report for criminal prosecution viola- tions of this chapter whenever he believes that the public interest will be adequately served and compliance with the chapter obtained by a suit- able written notice or warning. (Pub. L. 85–172, § 13, Aug. 28, 1957, 71 Stat. 447.) § 463. Rules and regulations (a) Storage and handling of poultry products; violation of regulations The Secretary may by regulations prescribe conditions under which poultry products capable of use as human food, shall be stored or other- wise handled by any person engaged in the busi- ness of buying, selling, freezing, storing, or transporting, in or for commerce, or importing, such articles, whenever the Secretary deems such action necessary to assure that such arti- cles will not be adulterated or misbranded when delivered to the consumer. Violation of any such regulation is prohibited. (b) Other necessary rules and regulations The Secretary shall promulgate such other rules and regulations as are necessary to carry out the provisions of this chapter. (c) Oral presentation of views In applying the provisions of section 553(c) of title 5 to proposed rule making under this chap- ter, an opportunity for the oral presentation of views shall be accorded all interested persons. (Pub. L. 85–172, § 14, Aug. 28, 1957, 71 Stat. 447; Pub. L. 90–492, § 13, Aug. 18, 1968, 82 Stat. 803.)