21 U.S.C. § 612 — Notification

Page 751 TITLE 21—FOOD AND DRUGS § 612 merce, (1) any such articles which (A) are ca- pable of use as human food and (B) are adul- terated or misbranded at the time of such sale, transportation, offer for sale or transpor- tation, or receipt for transportation; or (2) any articles required to be inspected under this subchapter unless they have been so inspected and passed; (d) Adulteration or misbranding do, with respect to any such articles which are capable of use as human food, any act while they are being transported in commerce or held for sale after such transportation, which is intended to cause or has the effect of causing such articles to be adulterated or mis- branded. (Mar. 4, 1907, ch. 2907, title I, § 10, formerly 8th par., 34 Stat. 1262; renumbered § 10 and amended Pub. L. 90–201, §§ 1, 7, Dec. 15, 1967, 81 Stat. 584, 589; Pub. L. 95–445, § 3, Oct. 10, 1978, 92 Stat. 1069.) Editorial Notes REFERENCES IN TEXT Act of August 27, 1958, referred to in subsec. (b), is Pub. L. 85–765, Aug. 27, 1958, 72 Stat. 862, which is classi- fied generally to chapter 48 (§ 1901 et seq.) of Title 7, Ag- riculture. For complete classification of this Act to the Code, see Tables. Sections 1903 and 1905 of Title 7, included within ref- erence to Act of August 27, 1958, were repealed by Pub. L. 95–445, § 5(b), Oct. 10, 1978, 92 Stat. 1069, effective as set forth in section 7 of Pub. L. 95–445, set out as an Ef- fective Date of 1978 Amendment note under section 603 of this title. CODIFICATION Section was formerly classified to section 78 of this title. AMENDMENTS 1978—Subsecs. (b) to (d). Pub. L. 95–445 added subsec. (b) and redesignated former subsecs. (b) and (c) as (c) and (d), respectively. 1967—Pub. L. 90–201, § 7, included the list of animals and prohibited, except in compliance with require- ments of this chapter, slaughtering animals or prepara- tion of articles capable of use as human food, sales, transportation, and other transactions, and acts of adulteration or misbranding, incorporating in subsec. (b)(2) existing prohibition on distributions in interstate or foreign commerce of noninspected articles. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1978 AMENDMENT Amendment by Pub. L. 95–445 effective one year after Oct. 10, 1978, and an additional eighteen month period thereafter in hardship cases, see section 7 of Pub. L. 95–445, set out as an Effective Date of 1978 Amendment note under section 603 of this title. EFFECTIVE DATE OF 1967 AMENDMENT Amendment by Pub. L. 90–201 effective Dec. 15, 1967, except that subsecs. (b)(1) and (c) of this section effec- tive upon expiration of sixty days after Dec. 15, 1967, see section 20(a) of Pub. L. 90–201, set out as an Effec- tive Date note under section 601 of this title. § 611. Devices, marks, labels, and certificates; simulations (a) Devices to be made under authorization of Secretary No brand manufacturer, printer, or other per- son, firm, or corporation shall cast, print, litho- graph, or otherwise make any device containing any official mark or simulation thereof, or any label bearing any such mark or simulation, or any form of official certificate or simulation thereof, except as authorized by the Secretary. (b) Other misconduct No person, firm, or corporation shall— (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 animal, 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. (Mar. 4, 1907, ch. 2907, title I, § 11, formerly 9th par., 34 Stat. 1263; renumbered § 11 and amended Pub. L. 90–201, §§ 1, 8, Dec. 15, 1967, 81 Stat. 584, 589.) Editorial Notes CODIFICATION Section was formerly classified to section 79 of this title. AMENDMENTS 1967—Pub. L. 90–201, § 8, clarified application to brand manufacturers and printers of existing prohibition against counterfeiting official marks, labels or certifi- cates, the provisions with respect to forgery, unauthor- ized use or failure to use official marks, or similar items, and similar offenses, and existing prohibitions with respect to false statements in official or nonoffi- cial certificates, and added restriction upon possession of official devices, or devices, labels, meat, or other ar- ticles bearing counterfeit official marks, counterfeit official certificates, or similar items, and prohibition against false representations. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1967 AMENDMENT Amendment by Pub. L. 90–201 effective Dec. 15, 1967, except that with respect to equines (other than horses) and their carcasses and parts thereof, meat, and meat food products thereof, amendment effective upon expi- ration of sixty days after Dec. 15, 1967, see section 20(b) of Pub. L. 90–201, set out as an Effective Date note under section 601 of this title. § 612. Notification Any establishment subject to inspection under this chapter that believes, or has reason to be- Page 752 TITLE 21—FOOD AND DRUGS § 613 lieve, that an adulterated or misbranded meat or meat food 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 meat or meat food product. (Mar. 4, 1907, ch. 2907, title I, § 12, as added Pub. L. 110–234, title XI, § 11017(a), May 22, 2008, 122 Stat. 1370, and Pub. L. 110–246, § 4(a), title XI, § 11017(a), June 18, 2008, 122 Stat. 1664, 2132.) Editorial Notes CODIFICATION Pub. L. 110–234 and Pub. L. 110–246 enacted identical sections. Pub. L. 110–234 was repealed by section 4(a) of Pub. L. 110–246. PRIOR PROVISIONS A prior section 612, acts Mar. 4, 1907, ch. 2907, title I, § 12, formerly 10th par., 34 Stat. 1263; renumbered § 12 and amended Pub. L. 90–201, §§ 1, 3(b), 12(a), Dec. 15, 1967, 81 Stat. 584, 588, 592, related to inspection of animals for export, prior to repeal by Pub. L. 107–171, title X, § 10418(a)(19), May 13, 2002, 116 Stat. 508. Section was for- merly classified to section 80 of this title. Statutory Notes and Related Subsidiaries EFFECTIVE DATE Enactment 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 a note under section 8701 of Title 7, Agriculture. § 613. 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 meat or meat food 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. (Mar. 4, 1907, ch. 2907, title I, § 13, as added Pub. L. 110–234, title XI, § 11017(a), May 22, 2008, 122 Stat. 1370, and Pub. L. 110–246, § 4(a), title XI, § 11017(a), June 18, 2008, 122 Stat. 1664, 2132.) Editorial Notes CODIFICATION Pub. L. 110–234 and Pub. L. 110–246 enacted identical sections. Pub. L. 110–234 was repealed by section 4(a) of Pub. L. 110–246. PRIOR PROVISIONS A prior section 613, acts Mar. 4, 1907, ch. 2907, title I, § 13, formerly 11th par., 34 Stat. 1263; renumbered § 13 and amended Pub. L. 90–201, §§ 1, 3(b), 12(a), Dec. 15, 1967, 81 Stat. 584, 588, 592, related to inspectors of animals for export and certificates of condition, prior to repeal by Pub. L. 107–171, title X, § 10418(a)(19), May 13, 2002, 116 Stat. 508. Section was formerly classified to section 81 of this title. Statutory Notes and Related Subsidiaries EFFECTIVE DATE Enactment 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 a note under section 8701 of Title 7, Agriculture. § 614. Repealed. Pub. L. 107–171, title X, § 10418(a)(19), May 13, 2002, 116 Stat. 508 Section, acts Mar. 4, 1907, ch. 2907, title I, § 14, for- merly 12th par., 34 Stat. 1263; renumbered § 14 and amended Pub. L. 90–201, §§ 1, 3(b), 12(a), Dec. 15, 1967, 81 Stat. 584, 588, 592, prohibited clearance to vessel car- rying animals for export without inspector’s certifi- cate. Section was formerly classified to section 82 of this title. § 615. Inspection of carcasses, meat of which is intended for export The Secretary shall also cause to be made a careful inspection of the carcasses and parts thereof of all amenable species, the meat of which, fresh, salted, canned, corned, packed, cured, or otherwise prepared, is intended and of- fered for export to any foreign country, at such times and places and in such manner as he may deem proper. (Mar. 4, 1907, ch. 2907, title I, § 15, formerly 13th par., 34 Stat. 1263; renumbered § 15 and amended Pub. L. 90–201, §§ 1, 3(b), 12(a), Dec. 15, 1967, 81 Stat. 584, 588, 592; Pub. L. 109–97, title VII, § 798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.) Editorial Notes CODIFICATION Section was formerly classified to section 83 of this title. AMENDMENTS 2005—Pub. L. 109–97 substituted ‘‘amenable species’’ for ‘‘cattle, sheep, swine, goats, horses, mules, and other equines’’. 1967—Pub. L. 90–201, §§ 3(b), 12(a), struck out ‘‘of Agri- culture’’ after ‘‘Secretary’’ and included horses, mules, and other equines in the list of animals, respectively. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2005 AMENDMENT Amendment by Pub. L. 109–97 effective the day after 120 days after Nov. 10, 2005, see section 798(b) of Pub. L. 109–97, set out as a note under section 601 of this title. EFFECTIVE DATE OF 1967 AMENDMENT Amendment by Pub. L. 90–201 effective Dec. 15, 1967, except that with respect to equines (other than horses) and their carcasses and parts thereof, meat, and meat food products thereof, amendment effective upon expi- ration of sixty days after Dec. 15, 1967, see section 20(b) of Pub. L. 90–201, set out as an Effective Date note under section 601 of this title. § 616. Inspectors of carcasses, etc., meat of which is intended for export; certificates of condi- tion For the purpose of section 615 of this title the Secretary may appoint inspectors who shall be authorized to give an official certificate stating the condition in which said cattle, sheep, swine, goats, horses, mules, or other equines, and the meat thereof, are found.