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21 U.S.C. § 601 — Definitions

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21 U.S.C. § 601 — Definitions

§ 601. Definitions As used in this chapter, except as otherwise specified, the following terms shall have the meanings stated below: (a) The term ‘‘Secretary’’ means the Secretary of Agriculture of the United States or his dele- gate. (b) The term ‘‘firm’’ means any partnership, association, or other unincorporated business organization. (c) The term ‘‘meat broker’’ means any per- son, firm, or corporation engaged in the business of buying or selling carcasses, parts of carcasses, meat, or meat food products of cattle, sheep, swine, goats, horses, mules, or other equines on commission, or otherwise negotiating purchases or sales of such articles other than for his own account or as an employee of another person, firm, or corporation. (d) The term ‘‘renderer’’ means any person, firm, or corporation engaged in the business of rendering carcasses or parts or products of the carcasses, of cattle, sheep, swine, goats, horses, mules, or other equines, except rendering con- ducted under inspection or exemption under this subchapter. (e) The term ‘‘animal food manufacturer’’ means any person, firm, or corporation engaged in the business of manufacturing or processing animal food derived wholly or in part from car- casses, or parts or products of the carcasses, of cattle, sheep, swine, goats, horses, mules, or other equines. (f) The term ‘‘State’’ means any State of the United States and the Commonwealth of Puerto Rico. (g) The term ‘‘Territory’’ means Guam, the Virgin Islands of the United States, American Samoa, and any other territory or possession of the United States, excluding the Canal Zone. (h) The term ‘‘commerce’’ means commerce between any State, any Territory, or the Dis- trict of Columbia, and any place outside thereof; or with

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Page 741 TITLE 21—FOOD AND DRUGS § 601 Sec. SUBCHAPTER II—MEAT PROCESSORS AND RELATED INDUSTRIES 641. Prohibition of subchapter I inspection of arti- cles not intended for use as human food; de- naturation or other identification prior to distribution in commerce; inedible articles. 642. Recordkeeping requirements. 643. Registration of business, name of person, and trade names. 644. Regulation of transactions, transportation, or importation of 4–D animals to prevent use as human food. 645. Federal provisions applicable to State or Ter- ritorial business transactions of a local na- ture and not subject to local authority. SUBCHAPTER III—FEDERAL AND STATE COOPERATION 661. Federal and State cooperation. SUBCHAPTER IV—AUXILIARY PROVISIONS 671. Inspection services; refusal or withdrawal; hearing; business unfitness based upon cer- tain convictions; other provisions for with- drawal of services unaffected; responsible connection with business; finality of Sec- retary’s actions; judicial review; record. 672. Administrative detention; duration; pending judicial proceedings; notification of govern- mental authorities; release. 673. Seizure and condemnation. 674. Federal court jurisdiction of enforcement and injunction proceedings and other kinds of cases; limitations of section 607(e) of this title. 675. Assaulting, resisting, or impeding certain persons; murder; protection of such persons. 676. Violations. 677. Other Federal laws applicable for administra- tion and enforcement of chapter; location of inquiries; jurisdiction of Federal courts. 678. Non-Federal jurisdiction of federally regu- lated matters; prohibition of additional or different requirements for establishments with inspection services and as to marking, labeling, packaging, and ingredients; rec- ordkeeping and related requirements; con- current jurisdiction over distribution for human food purposes of adulterated or mis- branded and imported articles; other mat- ters. 679. Application of Federal Food, Drug, and Cos- metic Act. 679a. Safe Meat and Poultry Inspection Panel. 679b. Pasteurization of meat and poultry. 679c. Expansion of Food Safety Inspection Service activities. 680. Authorization of appropriations. SUBCHAPTER IV–A—INSPECTIONS BY FEDERAL AND STATE AGENCIES 683. Interstate shipment of meat inspected by Federal and State agencies for certain small establishments. SUBCHAPTER V—MISCELLANEOUS PROVISIONS 691. Omitted. 692. Inspection extended to reindeer. 693. Inspection of dairy products for export. 694. Authorization of appropriations. 695. Payment of cost of meat-inspection service; exception. SUBCHAPTER I—INSPECTION REQUIRE- MENTS; ADULTERATION AND MIS- BRANDING § 601. Definitions As used in this chapter, except as otherwise specified, the following terms shall have the meanings stated below: (a) The term ‘‘Secretary’’ means the Secretary of Agriculture of the United States or his dele- gate. (b) The term ‘‘firm’’ means any partnership, association, or other unincorporated business organization. (c) The term ‘‘meat broker’’ means any per- son, firm, or corporation engaged in the business of buying or selling carcasses, parts of carcasses, meat, or meat food products of cattle, sheep, swine, goats, horses, mules, or other equines on commission, or otherwise negotiating purchases or sales of such articles other than for his own account or as an employee of another person, firm, or corporation. (d) The term ‘‘renderer’’ means any person, firm, or corporation engaged in the business of rendering carcasses or parts or products of the carcasses, of cattle, sheep, swine, goats, horses, mules, or other equines, except rendering con- ducted under inspection or exemption under this subchapter. (e) The term ‘‘animal food manufacturer’’ means any person, firm, or corporation engaged in the business of manufacturing or processing animal food derived wholly or in part from car- casses, or parts or products of the carcasses, of cattle, sheep, swine, goats, horses, mules, or other equines. (f) The term ‘‘State’’ means any State of the United States and the Commonwealth of Puerto Rico. (g) The term ‘‘Territory’’ means Guam, the Virgin Islands of the United States, American Samoa, and any other territory or possession of the United States, excluding the Canal Zone. (h) The term ‘‘commerce’’ means commerce between any State, any Territory, or the Dis- trict of Columbia, and any place outside thereof; or within any Territory not organized with a legislative body, or the District of Columbia. (i) The term ‘‘United States’’ means the States, the District of Columbia, and the Terri- tories of the United States. (j) The term ‘‘meat food product’’ means any product capable of use as human food which is made wholly or in part from any meat or other portion of the carcass of any cattle, sheep, swine, or goats, excepting products which con- tain meat or other portions of such carcasses only in a relatively small proportion or histori- cally have not been considered by consumers as products of the meat food industry, and which are exempted from definition as a meat food product by the Secretary under such conditions as he may prescribe to assure that the meat or other portions of such carcasses contained in such product are not adulterated and that such products are not represented as meat food prod- ucts. This term as applied to food products of equines shall have a meaning comparable to that provided in this paragraph with respect to cattle, sheep, swine, and goats. Page 742 TITLE 21—FOOD AND DRUGS § 601 (k) The term ‘‘capable of use as human food’’ shall apply to any carcass, or part or product of a carcass, of any animal, 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. (l) The term ‘‘prepared’’ means slaughtered, canned, salted, rendered, boned, cut up, or oth- erwise manufactured or processed. (m) The term ‘‘adulterated’’ shall apply to any carcass, part thereof, meat or meat food product under one or more of the following cir- cumstances: (1) if it bears or contains any poisonous or deleterious substance which may render it in- jurious to health; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health; (2)(A) if it bears or contains (by reason of ad- ministration of any substance to the live ani- mal or otherwise) any added poisonous or added deleterious substance (other than one which is (i) a pesticide chemical in or on a raw agricultural commodity; (ii) a food additive; or (iii) a color additive) which may, in the judgment of the Secretary, make such article unfit for human food; (B) if it is, in whole or in part, a raw agricul- tural commodity and such commodity bears or contains a pesticide chemical which is unsafe within the meaning of section 346a of this title, (C) if it bears or contains any food additive which is unsafe within the meaning of section 348 of this title, (D) if it bears or contains any color additive which is unsafe within the meaning of section 379e of this title: Provided, That an article which is not adulterated under clause (B), (C), or (D) shall nevertheless be deemed adulter- ated if use of the pesticide chemical, food ad- ditive, or color additive in or on such article is prohibited by regulations of the Secretary in establishments at which inspection is main- tained under this subchapter; (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance or is for any other reason unsound, unhealthful, un- wholesome, or otherwise unfit for human food; (4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; (5) if it is, in whole or in part, the product of an animal which has died otherwise than by slaughter; (6) if its container is composed, in whole or in part, of any poisonous or deleterious sub- stance which may render the contents inju- rious to health; (7) if it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 348 of this title; (8) if any valuable constituent has been in whole or in part omitted or abstracted there- from; or if any substance has been substituted, wholly or in part therefor; or if damage or in- feriority has been concealed in any manner; or if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of great- er value than it is; or (9) if it is margarine containing animal fat and any of the raw material used therein con- sisted in whole or in part of any filthy, putrid, or decomposed substance. (n) The term ‘‘misbranded’’ shall apply to any carcass, part thereof, meat or meat food product under one or more of the following cir- cumstances: (1) if its labeling is false or misleading in any particular; (2) if it is offered for sale under the name of another food; (3) if it is an imitation of another food, un- less its label bears, in type of uniform size and prominence, the word ‘‘imitation’’ and imme- diately thereafter, the name of the food imi- tated; (4) if its container is so made, formed, or filled as to be misleading; (5) if in a package or other container unless it bears a label showing (A) the name and place of business of the manufacturer, packer, or distributor; and (B) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count: Provided, That under clause (B) of this subparagraph (5), reasonable variations may be permitted, and exemptions as to small packages may be es- tablished, by regulations prescribed by the Secretary; (6) if any word, statement, or other informa- tion required by or under authority of this chapter to appear on the label or other label- ing is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordi- nary individual under customary conditions of purchase and use; (7) if it purports to be or is represented as a food for which a definition and standard of identity or composition has been prescribed by regulations of the Secretary under section 607 of this title unless (A) it conforms to such def- inition and standard, and (B) its label bears the name of the food specified in the definition and standard and, insofar as may be required by such regulations, the common names of op- tional ingredients (other than spices, fla- voring, and coloring) present in such food; (8) if it purports to be or is represented as a food for which a standard or standards of fill of container have been prescribed by regula- tions of the Secretary under section 607 of this title, and it falls below the standard of fill of container applicable thereto, unless its label bears, in such manner and form as such regu- lations specify, a statement that it falls below such standard; (9) if it is not subject to the provisions of subparagraph (7), unless its label bears (A) the common or usual name of the food, if any Page 743 TITLE 21—FOOD AND DRUGS § 601 there be, and (B) in case it is fabricated from two or more ingredients, the common or usual name of each such ingredient; except that spices, flavorings, and colorings may, when authorized by the Secretary, be designated as spices, flavorings, and colorings without nam- ing each: Provided, That to the extent that compliance with the requirements of clause (B) of this subparagraph (9) is impracticable, or results in deception or unfair competition, exemptions shall be established by regulations promulgated by the Secretary; (10) if it purports to be or is represented for special dietary uses, unless its label bears such information concerning its vitamin, mineral, and other dietary properties as the Secretary, after consultation with the Secretary of Health and Human Services, determines to be, and by regulations prescribes as, necessary in order fully to inform purchasers as to its value for such uses; (11) if it bears or contains any artificial fla- voring, artificial coloring, or chemical pre- servative, unless it bears labeling stating that fact: Provided, That, to the extent that compli- ance with the requirements of this subpara- graph (11) is impracticable, exemptions shall be established by regulations promulgated by the Secretary; or (12) if it fails to bear, directly thereon or on its container, as the Secretary may by regula- tions prescribe, the inspection legend and, un- restricted by any of the foregoing, such other information as the Secretary may require in such regulations to assure that it will not have false or misleading labeling and that the public will be informed of the manner of han- dling required to maintain the article in a wholesome condition. (o) The term ‘‘label’’ means a display of writ- ten, printed, or graphic matter upon the imme- diate container (not including package liners) of any article. (p) The term ‘‘labeling’’ means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article. (q) The term ‘‘Federal Food, Drug, and Cos- metic Act [21 U.S.C. 301 et seq.]’’ means the Act so entitled, approved June 25, 1938 (52 Stat. 1040), and Acts amendatory thereof or supplementary thereto. (r) 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.]. (s) The term ‘‘official mark’’ means the offi- cial inspection legend or any other symbol pre- scribed by regulations of the Secretary to iden- tify the status of any article or animal under this chapter. (t) The term ‘‘official inspection legend’’ means any symbol prescribed by regulations of the Secretary showing that an article was in- spected and passed in accordance with this chap- ter. (u) The term ‘‘official certificate’’ means any certificate prescribed by regulations of the Sec- retary for issuance by an inspector or other per- son performing official functions under this chapter. (v) The term ‘‘official device’’ means any de- vice prescribed or authorized by the Secretary for use in applying any official mark. (w) The term ‘‘amenable species’’ means— (1) those species subject to the provisions of this chapter on the day before November 10, 2005; (2) all fish of the order Siluriformes; and (3) any additional species of livestock that the Secretary considers appropriate. (Mar. 4, 1907, ch. 2907, title I, § 1, as added Pub. L. 90–201, § 2, Dec. 15, 1967, 81 Stat. 584; amended Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 102–571, title I, § 107(14), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 109–97, title VII, § 798[(a)](2), Nov. 10, 2005, 119 Stat. 2166; Pub. L. 110–234, title XI, § 11016(b)(1)(A), May 22, 2008, 122 Stat. 1369; Pub. L. 110–246, § 4(a), title XI, § 11016(b)(1)(A), June 18, 2008, 122 Stat. 1664, 2130; Pub. L. 113–79, title XII, § 12106(a)(1), Feb. 7, 2014, 128 Stat. 980.) Editorial Notes REFERENCES IN TEXT The Federal Food, Drug, and Cosmetic Act, referred to in pars. (q) and (r), 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. 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 2014—Subsec. (w)(2). Pub. L. 113–79 added par. (2) and struck out former par. (2) which read as follows: ‘‘cat- fish, as defined by the Secretary; and’’. 2008—Subsec. (w)(2), (3). Pub. L. 110–246, § 11016(b)(1)(A), added par. (2) and redesignated former par. (2) as (3). 2005—Par. (w). Pub. L. 109–97 added par. (w). 1992—Par. (m)(2)(D). Pub. L. 102–571 substituted ‘‘379e’’ for ‘‘376’’. 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. (n)(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 2014 AMENDMENT Pub. L. 113–79, title XII, § 12106(c), Feb. 7, 2014, 128 Stat. 982, provided that: ‘‘This section [amending this section, sections 606 and 625 of this title, and section 1622 of Title 7, Agriculture, and enacting and repealing provisions set out as notes under this section] and the amendments made by this section shall take effect as if enacted as part of section 11016(b) of the Food, Con- servation, and Energy Act of 2008 (Public Law 110–246; 122 Stat. 2130) [amending this section, enacting sections 606 and 625 of this title, repealing former section 606 of this title, and enacting provisions set out as notes below].’’ 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 Page 744 TITLE 21—FOOD AND DRUGS § 601 date of enactment of Pub. L. 110–234, except as other- wise provided, see section 4 of Pub. L. 110–246, set out as an Effective Date note under section 8701 of Title 7, Agriculture. Pub. L. 110–234, title XI, § 11016(b)(2)(A), May 22, 2008, 122 Stat. 1369, and Pub. L. 110–246, § 4(a), title XI, § 11016(b)(2)(A), June 18, 2008, 122 Stat. 1664, 2131, pro- vided that the amendments made by section 11016(b)(1) of Pub. L. 110–234 and section 11016(b)(1) of Pub. L. 110–246 (enacting sections 606 and 625 of this title, amending this section, and repealing former section 606 of this title) would not apply until the date on which the Secretary of Agriculture issued final regulations to carry out such amendments, prior to repeal by Pub. L. 113–79, title XII, § 12106(b)(4), Feb. 7, 2014, 128 Stat. 981, effective as if enacted as part of section 11016(b) of the Food, Conservation, and Energy Act of 2008 (Public Law 110–246; 122 Stat. 2130), see Effective Date of 2014 Amendment note above. [Pub. L. 110–234 and Pub. L. 110–246 enacted identical provisions. Pub. L. 110–234 was repealed by section 4(a) of Pub. L. 110–246, set out as a note under section 8701 of Title 7, Agriculture.] EFFECTIVE DATE OF 2005 AMENDMENT Pub. L. 109–97, title VII, § 798(b), Nov. 10, 2005, 119 Stat. 2166, provided that: ‘‘The amendments made by subsection (a) [amending this section and sections 603 to 605, 608, 609, 615, and 617 to 621 of this title] shall take effect on the day after the effective date of section 794 of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2006 [section 794 of Pub. L. 109–97, 119 Stat. 2164, ef- fective 120 days after Nov. 10, 2005].’’ EFFECTIVE DATE Pub. L. 90–201, § 20, Dec. 15, 1967, 81 Stat. 601, provided that: ‘‘This Act [see Short Title note below] shall be- come effective upon enactment [Dec. 15, 1967] except as provided in paragraphs (a) through (d): ‘‘(a) The provisions of paragraph (b)(1) and (c) of sec- tion 10 and the provisions of section 20 of the Federal Meat Inspection Act, as amended by sections 7 and 10 of this Act [sections 610 and 620 of this title], and the provisions of section 18 of this Act repealing paragraph (b) of section 306 of the Tariff Act of 1930 [section 1306(b) of Title 19, Customs Duties], shall become effec- tive upon the expiration of sixty days after enactment [Dec. 15, 1967], hereof. ‘‘(b) The provisions of title I of the Federal Meat In- spection Act, as amended by this Act [this subchapter], shall become effective with respect to equines (other than horses) and their carcasses and parts thereof, meat, and meat food products thereof upon the expira- tion of sixty days after enactment [Dec. 15, 1967] hereof. ‘‘(c) Section 11 of this Act, amending section 23, of the Federal Meat Inspection Act [section 623 of this title], shall become effective upon the expiration of sixty days after enactment hereof [Dec. 15, 1967]. ‘‘(d) Section 204 of the Federal Meat Inspection Act, as added by section 14 of this Act [section 644 of this title], shall become effective upon the expiration of sixty days after enactment hereof [Dec. 15, 1967].’’ SHORT TITLE OF 1986 AMENDMENT Pub. L. 99–641, title IV, § 401, Nov. 10, 1986, 100 Stat. 3567, provided that: ‘‘This title [amending sections 606, 609, 621, 671, and 676 of this title and enacting provisions set out as notes under sections 606, 609, 621, 671, and 676 of this title] may be cited as the ‘Processed Products Inspection Improvement Act of 1986’.’’ SHORT TITLE OF 1978 AMENDMENT Pub. L. 95–445, § 1, Oct. 10, 1978, 92 Stat. 1069, provided: ‘‘That this Act [amending sections 603, 610, and 620 of this title and sections 1902 and 1904 of Title 7, Agri- culture, repealing sections 1903 and 1905 of Title 7, and enacting provisions set out as notes under this section and section 603 of this title] may be cited as the ‘Hu- mane Methods of Slaughter Act of 1978’.’’ SHORT TITLE Pub. L. 90–201, § 1, Dec. 15, 1967, 81 Stat. 584, provided in part: ‘‘That this Act [enacting this section and sec- tions 602, 624, 641 to 645, 661, 671 to 680, and 691 of this title, amending sections 603 to 623 of this title, repeal- ing section 96 of this title and section 1306(b) of Title 19, Customs Duties, and enacting provisions set out as notes under this section] may be cited as the ‘Whole- some Meat Act’.’’ Pub. L. 90–201, § 1, Dec. 15, 1967, 81 Stat. 584, provided in part that the provisions of act Mar. 4, 1907, as amended, classified to subchapters I to IV–A of this chapter, are designated as the ‘‘Federal Meat Inspec- tion Act’’. REGULATIONS Pub. L. 113–79, title XII, § 12106(b)(1)–(3), Feb. 7, 2014, 128 Stat. 981, provided that: ‘‘(1) IN GENERAL.—The Secretary shall— ‘‘(A) not later than 60 days after the date of enact- ment of this Act [Feb. 7, 2014], issue final regulations to carry out the amendments made by section 11016(b)(1) of the Food, Conservation, and Energy Act of 2008 (Public Law 110–246; 122 Stat. 2130) [amending this section, enacting sections 606 and 625 of this title, and repealing former section 606 of this title], as further clarified by the amendments made by this section [amending this section, sections 606 and 625 of this title, and section 1622 of Title 7, Agriculture, and enacting and repealing provisions set out as notes under this section]; and ‘‘(B) not later than 1 year after the date of enact- ment of this Act, implement the amendments de- scribed in subparagraph (A). ‘‘(2) NOTIFICATION.—Beginning 30 days after the date of enactment of this Act and every 30 days thereafter until the date of full implementation of the amend- ments described in paragraph (1)(A), the Secretary shall submit a report describing the status of imple- mentation to— ‘‘(A) the Committee on Agriculture of the House of Representatives; ‘‘(B) the Committee on Agriculture, Nutrition and Forestry of the Senate; ‘‘(C) the Subcommittee on Agriculture, Rural De- velopment, Food and Drug Administration, and Re- lated Agencies of the Committee on Appropriations of the House of Representatives; and ‘‘(D) the Subcommittee on Agriculture, Rural De- velopment, and Related Agencies of the Committee on Appropriations of the Senate. ‘‘(3) PROCEDURE.—Section 1601(c)(2) [7 U.S.C. 9091(c)(2)] applies to the promulgation of the regula- tions and administration of this section and the amend- ments made by this section.’’ Pub. L. 110–246, title XI, § 11016(b)(2), as added by Pub. L. 113–79, title XII, § 12106(b)(4), Feb. 7, 2014, 128 Stat. 981, provided that: ‘‘(A) REGULATIONS.—Not later than 60 days after the date of enactment of the Agricultural Act of 2014 [Feb. 7, 2014], the Secretary [of Agriculture], in consultation with the Commissioner of Food and Drugs, shall issue final regulations to carry out the amendments made by paragraph (1) [amending this section, enacting sections 606 and 625 of this title, and repealing former section 606 of this title] and section 12106 of that Act [amending this section, sections 606 and 625 of this title, and sec- tion 1622 of Title 7, Agriculture, and enacting and re- pealing provisions set out as notes under this section] in a manner that ensures that there is no duplication in inspection activities. ‘‘(B) INTERAGENCY COORDINATION.—Not later than 60 days after the date of enactment of the Agricultural Act of 2014, the Secretary shall execute a memorandum of understanding with the Commissioner of Food and Drugs for the following purposes: ‘‘(i) To improve interagency cooperation on food safety and fraud prevention, building upon any other prior agreements, including provisions, performance metrics, and timelines as appropriate. Page 745 TITLE 21—FOOD AND DRUGS § 603 ‘‘(ii) To maximize the effectiveness of limited per- sonnel and resources by ensuring that— ‘‘(I) inspections conducted by the Department satisfy requirements under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); ‘‘(II) inspections of shipments and processing fa- cilities for fish of the order Siluriformes by the De- partment and the Food and Drug Administration are not duplicative; and ‘‘(III) any information resulting from examina- tion, testing, and inspections conducted is consid- ered in making risk-based determinations, includ- ing the establishment of inspection priorities.’’ Pub. L. 110–234, title XI, § 11016(b)(2)(B), May 22, 2008, 122 Stat. 1370, and Pub. L. 110–246, § 4(a), title XI, § 11016(b)(2)(B), June 18, 2008, 122 Stat. 1664, 2131, re- quired the Secretary of Agriculture, in consultation with the Commissioner of Food and Drugs, to issue final regulations to carry out the amendments made by section 11016(b)(1) of Pub. L. 110–234 and section 11016(b)(1) of Pub. L. 110–246 (enacting sections 606 and 625 of this title, amending this section, and repealing former section 606 of this title) not later than 18 months after June 18, 2008, prior to repeal by Pub. L. 113–79, title XII, § 12106(b)(4), Feb. 7, 2014, 128 Stat. 981, effective as if enacted as part of section 11016(b) of the Food, Conservation, and Energy Act of 2008 (Public Law 110–246; 122 Stat. 2130), see Effective Date of 2014 Amendment note above. [Pub. L. 110–234 and Pub. L. 110–246 enacted identical provisions. Pub. L. 110–234 was repealed by section 4(a) of Pub. L. 110–246, set out as a note under section 8701 of Title 7, Agriculture.] SEPARABILITY Pub. L. 90–201, § 19, Dec. 15, 1967, 81 Stat. 601, provided that: ‘‘If any provision of this Act or of the amend- ments made hereby [see Short Title note above] or the application thereof to any person or circumstances is held invalid, the validity of the remainder of the Act and the remaining amendments [see Short Title note above] and of the application of such provision to other persons and circumstances shall not be affected there- by.’’ § 602. Congressional statement of findings Meat and meat food products are an important source of the Nation’s total supply of food. They are consumed throughout the Nation and the major portion thereof moves in interstate or for- eign commerce. It is essential in the public in- terest that the health and welfare of consumers be protected by assuring that meat and meat food products distributed to them are whole- some, not adulterated, and properly marked, la- beled, and packaged. Unwholesome, adulterated, or misbranded meat or meat food products im- pair the effective regulation of meat and meat food products in interstate or foreign commerce, are injurious to the public welfare, destroy mar- kets for wholesome, not adulterated, and prop- erly labeled and packaged meat and meat food products, and result in sundry losses to live- stock producers and processors of meat and meat food products, as well as injury to con- sumers. The unwholesome, adulterated, mis- labeled, or deceptively packaged articles can be sold at lower prices and compete unfairly with the wholesome, not adulterated, and properly la- beled and packaged articles, to the detriment of consumers and the public generally. It is hereby found that all articles and animals which are regulated under this chapter are either in inter- state or foreign commerce or substantially af- fect such commerce, and that regulation by the Secretary and cooperation by the States and other jurisdictions as contemplated by this chapter are appropriate to prevent and elimi- nate burdens upon such commerce, to effectively regulate such commerce, and to protect the health and welfare of consumers. (Mar. 4, 1907, ch. 2907, title I, § 2, as added Pub. L. 90–201, § 2, Dec. 15, 1967, 81 Stat. 587.) § 603. Examination of animals prior to slaughter; use of humane methods (a) Examination of animals before slaughtering; diseased animals slaughtered separately and carcasses examined For the purpose of preventing the use in com- merce of meat and meat food products which are adulterated, the Secretary shall cause to be made, by inspectors appointed for that purpose, an examination and inspection of all amenable species before they shall be allowed to enter into any slaughtering, packing, meat-canning, ren- dering, or similar establishment, in which they are to be slaughtered and the meat and meat food products thereof are to be used in com- merce; and all amenable species found on such inspection to show symptoms of disease shall be set apart and slaughtered separately from all other cattle, sheep, swine, goats, horses, mules, or other equines, and when so slaughtered the carcasses of said cattle, sheep, swine, goats, horses, mules, or other equines shall be subject to a careful examination and inspection, all as provided by the rules and regulations to be pre- scribed by the Secretary, as provided for in this subchapter. (b) Humane methods of slaughter For the purpose of preventing the inhumane slaughtering of livestock, the Secretary shall cause to be made, by inspectors appointed for that purpose, an examination and inspection of the method by which amenable species are slaughtered and handled in connection with slaughter in the slaughtering establishments in- spected under this chapter. The Secretary may refuse to provide inspection to a new slaugh- tering establishment or may cause inspection to be temporarily suspended at a slaughtering es- tablishment if the Secretary finds that any cat- tle, sheep, swine, goats, horses, mules, or other equines have been slaughtered or handled in connection with slaughter at such establish- ment by any method not in accordance with the Act of August 27, 1958 (72 Stat. 862; 7 U.S.C. 1901–1906) until the establishment furnishes as- surances satisfactory to the Secretary that all slaughtering and handling in connection with slaughter of livestock shall be in accordance with such a method. (Mar. 4, 1907, ch. 2907, title I, § 3, formerly 1st par., 34 Stat. 1260; renumbered § 3 and amended Pub. L. 90–201, §§ 1, 3, 12(a), (b), Dec. 15, 1967, 81 Stat. 584, 588, 592; Pub. L. 95–445, § 2, Oct. 10, 1978, 92 Stat. 1069; Pub. L. 109–97, title VII, § 798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.) 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-

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21 U.S.C. § 301 — Short title

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

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21 U.S.C. § 301 — 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), (e), (f), (g), and (h) [352(b), (d) to (h) of this title]; and 602(b) [362(b) of this title] of such Act with respect to lithographed labeling which was manu- factured prior to February 1, 1939, and to containers bearing labeling which, prior to February 1, 1939, was lithographed, etched, stamped, pressed, printed, fused or blown on or in such containers, where compliance with such provisions would be unduly burdensome by reason of causing the loss of valuable stocks of such la- beling or containers, and where such postponement would not prevent the public interest being adequately served: Provided, That in no case shall such regulations apply to labeling which would not have complied with the requirements of the Food and Drugs Act of June 30, 190

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21 U.S.C. § 601 — Definitions

As used in this chapter, except as otherwise specified, the following terms shall have the meanings stated below: **(a)** The term “Secretary” means the Secretary of Agriculture of the United States or his delegate. **(b)** The term “firm” means any partnership, association, or other unincorporated business organization. **(c)** The term “meat broker” means any person, firm, or corporation engaged in the business of buying or selling carcasses, parts of carcasses, meat, or meat food products of cattle, sheep, swine, goats, horses, mules, or other equines on commission, or otherwise negotiating purchases or sales of such articles other than for his own account or as an employee of another person, firm, or corporation. **(d)** The term “renderer” means any person, firm, or corporation engaged in the business of rendering carcasses or parts or products of the carcasses, of cattle, sheep, swine, goats, horses, mules, or other equines, except rendering conducted under inspection or exemption under this subchapter. **(e)** The term “animal food manufacturer” means any person, firm, or corporation engaged in the business of manufacturing or processing animal food derived wholly or in part from carcasses, or parts or products of the carcasses, of cattle, sheep, swine, goats, horses, mules, or other equines. **(f)** The term “State” means any State of the United States and the Commonwealth of Puerto Rico. **(g)** The term “Territory” means Guam, the Virgin Islands of the United States, American Samoa, and any other territory or possession of the United States, excluding the Canal Zone. **(h)** The term “commerce” means commerce between any State, any Territory, or the District of Columbia, and any place outside thereof; or within any Territory not organized with a legisl

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7 U.S.C. § 1901 — Findings and declaration of policy

The Congress finds that the use of humane methods in the slaughter of livestock prevents needless suffering; results in safer and better working conditions for persons engaged in the slaughtering industry; brings about improvement of products and economies in slaughtering operations; and produces other benefits for producers, processors, and consumers which tend to expedite an orderly flow of livestock and livestock products in interstate and foreign commerce. It is therefore declared to be the policy of the United States that the slaughtering of livestock and the handling of livestock in connection with slaughter shall be carried out only by humane methods.

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7 U.S.C. § 1901 — Findings and declaration of policy

§ 1901. Findings and declaration of policy The Congress finds that the use of humane methods in the slaughter of livestock prevents needless suffering; results in safer and better working conditions for persons engaged in the slaughtering industry; brings about improve- ment of products and economies in slaughtering operations; and produces other benefits for pro- ducers, processors, and consumers which tend to expedite an orderly flow of livestock and live- stock products in interstate and foreign com- merce. It is therefore declared to be the policy of the United States that the slaughtering of livestock and the handling of livestock in con- nection with slaughter shall be carried out only by humane methods. (Pub. L. 85–765, § 1, Aug. 27, 1958, 72 Stat. 862.) Statutory Notes and Related Subsidiaries SHORT TITLE OF 1978 AMENDMENT For citation of Pub. L. 95–445, Oct. 10, 1978, 92 Stat. 1069, as the ‘‘Humane Methods of Slaughter Act of 1978’’, see Short Title of 1978 Amendment note set out under section 601 of Title 21, Food and Drugs. ENFORCEMENT OF HUMANE METHODS OF SLAUGHTER ACT OF 1958 Pub. L. 107–171, title X, § 10305, May 13, 2002, 116 Stat. 493, provided that: Page 1052 TITLE 7—AGRICULTURE § 1902 ‘‘(a) SENSE OF CONGRESS.—It is the sense of Congress that the Secretary of Agriculture should— ‘‘(1) continue tracking the number of violations of Public Law 85–765 (7 U.S.C. 1901 et seq.; commonly known as the ‘Humane Methods of Slaughter Act of 1958’) and report the results and relevant trends annu- ally to Congress; and ‘‘(2) fully enforce Public Law 85–765 by ensuring that humane methods in the slaughter of livestock— ‘‘(A) prevent needless suffering; ‘‘(B) result in safer and better working conditions for persons engaged in slaughtering

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7 U.S.C. § 9091 — Supplemental agricultural disaster assistance

**(a) Definitions** In this section: (1) **Covered producer** — The term “covered producer” means an eligible producer on a farm that is— (A) as determined by the Secretary— (i) a beginning farmer or rancher; (ii) a socially disadvantaged farmer or rancher; or (iii) a limited resource farmer or rancher; or (B) a veteran farmer or rancher, as defined in [section 2279(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title7-section2279/a&num=0&edition=prelim). (2) **Eligible producer on a farm** (A) *In general* — The term “eligible producer on a farm” means an individual or entity described in subparagraph (B) that, as determined by the Secretary, assumes the production and market risks associated with the agricultural production of crops or livestock. (B) *Description* — An individual or entity referred to in subparagraph (A) is— (i) a citizen of the United States; (ii) a resident alien; (iii) an Indian tribe or tribal organization (as those terms are defined in [section 5304 of title 25](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title25-section5304&num=0&edition=prelim)); (iv) a partnership of citizens of the United States; or (v) a corporation, limited liability corporation, or other farm organizational structure organized under State law. (3) **Farm-raised fish** — The term “farm-raised fish” means any aquatic species that is propagated and reared in a controlled environment. (4) **Livestock** — The term “livestock” includes— (A) cattle (including dairy cattle); (B) bison; (C) poultry; (D) sheep; (E) swine; (F) horses; and (G) other livestock, as determined by the Secretary. (5) **Secretary** — The term “Secretary” means the Secretary of Agric

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

7 U.S.C. § 9091 — Administration generally

§ 9091. Administration generally (a) Use of Commodity Credit Corporation The Secretary shall use the funds, facilities, and authorities of the Commodity Credit Cor- poration to carry out this chapter. (b) Determinations by Secretary A determination made by the Secretary under this chapter shall be final and conclusive. (c) Regulations (1) In general Except as otherwise provided in this sub- section, not later than 90 days after February 7, 2014, the Secretary and the Commodity Credit Corporation, as appropriate, shall pro- mulgate such regulations as are necessary to implement this chapter and the amendments made by this chapter. (2) Procedure The promulgation of the regulations and ad- ministration of this chapter and the amend- ments made by this chapter, sections 11003 and 11017, title I of the Agriculture Improvement Act of 2018 and the amendments made by that title, and section 10109 of that Act shall be made without regard to— (A) the notice and comment provisions of section 553 of title 5; and (B) chapter 35 of title 44 (commonly known as the ‘‘Paperwork Reduction Act’’). (3) Congressional review of agency rulemaking In carrying out this subsection, the Sec- retary shall use the authority provided under section 808 of title 5. (d) Adjustment authority related to trade agree- ments compliance (1) Required determination; adjustment If the Secretary determines that expendi- tures under this chapter that are subject to the total allowable domestic support levels under the Uruguay Round Agreements (as de- fined in section 3501 of title 19) will exceed such allowable levels for any applicable re- porting period, the Secretary shall, to the maximum extent practicable, make adjust- ments in the amount of such expenditures dur- ing that pe

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