21 U.S.C. § 661 — Federal and State cooperation

Page 760 TITLE 21—FOOD AND DRUGS § 643 firms, and corporations subject to such require- ments shall, at all reasonable times upon notice by a duly authorized representative of the Sec- retary, afford such representative access to their places of business and opportunity to ex- amine 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 persons, firms, or corporations that engage, for commerce, in the business of slaughtering any cattle, sheep, swine, goats, horses, mules, or other equines, or preparing, freezing, packaging, or labeling any carcasses, or parts or products of carcasses, of any such animals, for use as human food or animal food; (2) Any persons, firms, or corporations that engage in the business of buying or selling (as meat brokers, wholesalers or otherwise), or transporting in commerce, or storing in or for commerce, or importing, any carcasses, or parts or products of carcasses, of any such ani- mals; (3) Any persons, firms, or corporations that engage in business, in or for commerce, as ren- derers, or engage in the business of buying, selling, or transporting, in commerce, or im- porting, any dead, dying, disabled, or diseased cattle, sheep, swine, goats, horses, mules, or other equines, or parts of the carcasses of any such animals that died otherwise than by slaughter. (b) Period of maintenance Any record required to be maintained by this section shall be maintained for such period of time as the Secretary may by regulations pre- scribe. (Mar. 4, 1907, ch. 2907, title II, § 202, as added Pub. L. 90–201, § 14, Dec. 15, 1967, 81 Stat. 593.) § 643. Registration of business, name of person, and trade names No person, firm, or corporation shall engage in business, in or for commerce, as a meat broker, renderer, or animal food manufacturer, or en- gage in business in commerce as a wholesaler of any carcasses, or parts or products of the car- casses, of any cattle, sheep, swine, goats, horses, mules, or other equines, whether intended for human food or other purposes, or engage in busi- ness 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, dis- abled, or diseased animals of the specified kinds, or parts of the carcasses of any such animals 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. (Mar. 4, 1907, ch. 2907, title II, § 203, as added Pub. L. 90–201, § 14, Dec. 15, 1967, 81 Stat. 594.) § 644. Regulation of transactions, transportation, or importation of 4–D animals to prevent use as human food No person, firm, or corporation engaged in the business of buying, selling, or transporting in commerce, or importing, dead, dying, disabled, or diseased animals, or any parts of the car- casses of any animals that died otherwise than by slaughter, shall buy, sell, transport, offer for sale or transportation, or receive for transpor- tation, in commerce, or import, any dead, dying, disabled, or diseased cattle, sheep, swine, goats, horses, mules or other equines, or parts of the carcasses of any such animals that died other- wise than by slaughter, unless such transaction, transportation or importation is made in ac- cordance with such regulations as the Secretary may prescribe to assure that such animals, or the unwholesome parts or products thereof, will be prevented from being used for human food purposes. (Mar. 4, 1907, ch. 2907, title II, § 204, as added Pub. L. 90–201, § 14, Dec. 15, 1967, 81 Stat. 594.) § 645. Federal provisions applicable to State or Territorial business transactions of a local nature and not subject to local authority The authority conferred on the Secretary by section 642, 643, or 644 of this title with respect to persons, firms, and corporations engaged in the specified kinds of business in or for com- merce may be exercised with respect to persons, firms, or corporations 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 661 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 providing for the Secretary or his representative being afforded access to such places of business and the facili- ties, inventories, and records thereof, and the taking of reasonable samples, where he deter- mines necessary in carrying out his responsibil- ities under this chapter; and in such case the provisions of section 642, 643, or 644 of this title, respectively, shall apply to such persons, firms, and corporations to the same extent and in the same manner as if they were engaged in such business in or for commerce and the trans- actions involved were in commerce. (Mar. 4, 1907, ch. 2907, title II, § 205, as added Pub. L. 90–201, § 14, Dec. 15, 1967, 81 Stat. 594.) SUBCHAPTER III—FEDERAL AND STATE COOPERATION § 661. Federal and State cooperation (a) Congressional statement of policy It is the policy of the Congress to protect the consuming public from meat and meat food products that are adulterated or misbranded and to assist in efforts by State and other Govern- ment agencies to accomplish this objective. In furtherance of this policy— (1) Development and administration of State meat inspection program equal to sub- chapter I ante and post mortem inspection, reinspection, and sanitation requirements The Secretary is authorized, whenever he de- termines that it would effectuate the purposes Page 761 TITLE 21—FOOD AND DRUGS § 661 of this chapter, to cooperate with the appro- priate State agency in developing and admin- istering a State meat inspection program in any State which has enacted a State meat in- spection law that imposes mandatory ante mortem and post mortem inspection, reinspec- tion and sanitation requirements that are at least equal to those under subchapter I of this chapter, with respect to all or certain classes of persons engaged in the State in slaugh- tering cattle, sheep, swine, goats, or equines, or preparing the carcasses, parts thereof, meat or meat food products, of any such animals for use as human food solely for distribution with- in such State. (2) Development and administration of State program with authorities equal to sub- chapter II authorities; cooperation with Federal agencies The Secretary is further authorized, when- ever he determines that it would effectuate the purposes of this chapter, to cooperate with appropriate State agencies in developing and administering State programs under State laws containing authorities at least equal to those provided in subchapter II of this chap- ter; and to cooperate with other agencies of the United States in carrying out any provi- sions of this chapter. (3) Scope of cooperation: advisory assistance, technical and laboratory assistance and training, and financial and other aid; limi- tation on amount; equitable allocation of Federal funds; adequacy of State program to obtain Federal cooperation and pay- ments Cooperation with State agencies under this section may include furnishing to the appro- priate State agency (i) advisory assistance in planning and otherwise developing an ade- quate State program under the State law; and (ii) technical and laboratory assistance and training (including necessary curricular and instructional materials and equipment), and financial and other aid for administration of such a program. The amount to be contributed to any State by the Secretary under this sec- tion from Federal funds for any year shall not exceed 50 per centum of the estimated total cost of the cooperative program; and the Fed- eral funds shall be allocated among the States desiring to cooperate on an equitable basis. Such cooperation and payment shall be con- tingent at all times upon the administration of the State program in a manner which the Secretary, in consultation with the appro- priate advisory committee appointed under paragraph (4), deems adequate to effectuate the purposes of this section. (4) Advisory committees The Secretary may appoint advisory com- mittees consisting of such representatives of appropriate State agencies as the Secretary and the State agencies may designate to con- sult with him concerning State and Federal programs with respect to meat inspection and other matters within the scope of this chapter, including evaluating State programs for pur- poses of this chapter and obtaining better co- ordination and more uniformity among the State programs and between the Federal and State programs and adequate protection of consumers. (b) Single State agency; subordinate govern- mental unit as part of State agency The appropriate State agency with which the Secretary may cooperate under this chapter shall be a single agency in the State which is primarily responsible for the coordination of the State programs having objectives similar to those under this chapter. When the State pro- gram includes performance of certain functions by a municipality or other subordinate govern- mental unit, such unit shall be deemed to be a part of the State agency for purposes of this sec- tion. (c) State meat inspection requirements (1) Notice to Governor of nondevelopment or nonenforcement; designation of State as sub- ject to subchapters I and IV; delay and rev- ocation of designation; publication in Fed- eral Register; notice of production of adul- terated meat or meat food products; designa- tion of State If the Secretary has reason to believe, by thir- ty days prior to the expiration of two years after December 15, 1967, that a State has failed to de- velop or is not enforcing, with respect to all es- tablishments within its jurisdiction (except those that would be exempted from Federal in- spection under subparagraph (2)) at which cat- tle, sheep, swine, goats, or equines are slaugh- tered, or their carcasses, or parts or products thereof, are prepared for use as human food, solely for distribution within such State, and the products of such establishments, require- ments at least equal to those imposed under subchapter I and IV of this chapter, he shall promptly notify the Governor of the State of this fact. If the Secretary determines, after con- sultation with the Governor of the State, or rep- resentative selected by him, that such require- ments have not been developed and activated, he shall promptly after the expiration of such two- year period designate such State as one in which the provisions of subchapters I and IV of this chapter shall apply to operations and trans- actions wholly within such State: Provided, That if the Secretary has reason to believe that the State will activate such requirements within one additional year, he may delay such designa- tion for said period, and not designate the State, if he determines at the end of the year that the State then has such requirements in effective operation. The Secretary shall publish any such designation in the Federal Register and, upon the expiration of thirty days after such publica- tion, the provisions of subchapters I and IV shall apply to operations and transactions and to per- sons, firms, and corporations engaged therein in the State to the same extent and in the same manner as if such operations and transactions were conducted in or for commerce. Thereafter, upon request of the Governor, the Secretary shall revoke such designation if the Secretary determines that such State has developed and will enforce requirements at least equal to those imposed under subchapter I and subchapter IV of Page 762 TITLE 21—FOOD AND DRUGS § 661 1 See References in Text note below. this chapter: And provided further, That, not- withstanding any other provision of this section, if the Secretary determines that any establish- ment within a State is producing adulterated meat or meat food products for distribution within such State which would clearly endanger the public health he shall notify the Governor of the State and the appropriate Advisory Com- mittee provided by section 661 of this title of such fact for effective action under State or local law. If the State does not take action to prevent such endangering of the public health within a reasonable time after such notice, as determined by the Secretary, in light of the risk to public health, the Secretary may forthwith designate any such establishment as subject to the provisions of subchapters I and IV of this chapter, and thereupon the establishment and operator thereof shall be subject to such provi- sions as though engaged in commerce until such time as the Secretary determines that such State has developed and will enforce require- ments at least equal to those imposed under subchapter I and subchapter IV of this chapter. (2) Exemptions of retail stores, restaurants, and similar retail-type establishments; operations conducted at a restaurant central kitchen fa- cility The provisions of this chapter requiring in- spection of the slaughter of animals and the preparation of carcasses, parts thereof, meat and meat food products shall not apply to oper- ations of types traditionally and usually con- ducted at retail stores and restaurants, when conducted at any retail store or restaurant or similar retail-type establishment for sale in nor- mal retail quantities or service of such articles to consumers at such establishments if such es- tablishments are subject to such inspection pro- visions only under this paragraph (c). For the purposes of this subparagraph, operations con- ducted at a restaurant central kitchen facility shall be considered as being conducted at a res- taurant if the restaurant central kitchen pre- pares meat or meat food products that are ready to eat when they leave such facility and are served in meals or as entrees only to customers at restaurants owned or operated by the same person, firm, or corporation owning or operating such facility: Provided, That such facility shall be subject to the provisions of section 642 of this title: Provided further, That the facility may be subject to the inspection requirements under subchapter I of this chapter for as long as the Secretary deems necessary, if the Secretary de- termines that the sanitary conditions or prac- tices of the facility or the processing procedures or methods at the facility are such that any of its meat or meat food products are rendered adulterated. (3) Termination of designation of State upon de- velopment and enforcement of minimum re- quirements; redesignation; designation for nonenforcement of minimum requirements: notice and publication in Federal Register Whenever the Secretary determines that any State designated under this paragraph (c) has developed and will enforce State meat inspec- tion requirements at least equal to those im- posed under subchapters I and IV, with respect to the operations and transactions within such State which are regulated under paragraph (1), he shall terminate the designation of such State under this paragraph (c), but this shall not pre- clude the subsequent redesignation of the State at any time upon thirty days notice to the Gov- ernor and publication in the Federal Register in accordance with this paragraph, and any State may be designated upon such notice and publica- tion at any time after the period specified in this paragraph whether or not the State has theretofore been designated upon the Secretary determining that it is not effectively enforcing requirements at least equal to those imposed under subchapters I and IV. (4) Periodic review; report to Congressional com- mittees The Secretary shall promptly upon December 15, 1967, and periodically thereafter, but at least annually, review the requirements, including the enforcement thereof, of the several States not designated under this paragraph (c), with re- spect to the slaughter, and the preparation, storage, handling and distribution of carcasses, parts thereof, meat and meat food products, of such animals, and inspection of such operations and annually report thereon to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate in the report re- quired under section 691 1 of this title. (d) ‘‘State’’ defined As used in this section, the term ‘‘State’’ means any State (including the Commonwealth of Puerto Rico) or organized Territory. (Mar. 4, 1907, ch. 2907, title III § 301, as added Pub. L. 90–201, § 15, Dec. 15, 1967, 81 Stat. 595; amended Pub. L. 98–487, § 1, Oct. 17, 1984, 98 Stat. 2264; Pub. L. 103–437, § 8(2), Nov. 2, 1994, 108 Stat. 4588.) Editorial Notes REFERENCES IN TEXT Section 691 of this title, referred to in subsec. (c)(4), was omitted from the Code. CODIFICATION In subsec. (c)(1), (4), ‘‘December 15, 1967’’ substituted for ‘‘enactment of the Wholesome Meat Act’’. AMENDMENTS 1994—Subsec. (c)(4). Pub. L. 103–437 substituted ‘‘Agri- culture, Nutrition, and Forestry’’ for ‘‘Agriculture and Forestry’’. 1984—Subsec. (c)(2). Pub. L. 98–487 inserted provisions relating to operations conducted at a restaurant cen- tral kitchen facility. Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section effective Dec. 15, 1967, see section 20 of Pub. L. 90–201, set out as a note under section 601 of this title. TERMINATION OF ADVISORY COMMITTEES Advisory committees in existence on Jan. 5, 1973, to terminate not later than the expiration of the 2-year Page 763 TITLE 21—FOOD AND DRUGS § 672 period following Jan. 5, 1973, and advisory committees established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless in the case of a committee established by the President or an officer of the Federal Government, such committee is renewed by appropriate action prior to the expiration of such 2- year period, or in the case of a committee established by Congress, its duration is otherwise provided by law. See section 1013 of Title 5, Government Organization and Employees. 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 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 subchapter I of this chapter with respect to any establish- ment if he determines, after opportunity for a hearing is accorded to the applicant for, or re- cipient of, such service, that such applicant or recipient is unfit to engage in any business re- quiring inspection under subchapter I because the applicant or recipient, or anyone responsibly connected with the applicant or recipient, has been convicted, in any Federal or State court, of (1) any felony, or (2) more than one violation of any law, other than a felony, based upon the ac- quiring, handling, or distributing of unwhole- some, mislabeled, or deceptively packaged food or upon fraud in connection with transactions in food. This section shall not affect in any way other provisions of this chapter for withdrawal of inspection services under subchapter I from establishments failing to maintain sanitary con- ditions or to destroy condemned carcasses, parts, meat or meat food products. For the purpose of this section 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. The determination and order of the Secretary with respect thereto under this section shall be final and conclusive unless the affected appli- cant for, or recipient of, inspection service files application for judicial review within thirty days after the effective date of such order in the appropriate court as provided in section 674 of this title. Judicial review of any such order shall be upon the record upon which the deter- mination and order are based. (Mar. 4, 1907, ch. 2907, title IV, § 401, as added Pub. L. 90–201, § 16, Dec. 15, 1967, 81 Stat. 597; amended Pub. L. 99–641, title IV, § 403(b), Nov. 10, 1986, 100 Stat. 3568.) Editorial Notes AMENDMENTS 1986—Subsec. (a). Pub. L. 99–641, § 403(b)(1), (2)(B), (C), temporarily designated provisions which related to au- thority to refuse or withdraw inspection service as sub- sec. (a), struck out ‘‘any felony, or (2)’’ after ‘‘of (1)’’, and inserted ‘‘or (2) any felony’’ after ‘‘transactions in food’’. See Effective and Termination Dates of 1986 Amendment note below. Pub. L. 99–641, § 403(b)(2)(A), which directed that sub- sec. (a) be amended by substituting ‘‘applicant for’’ for ‘‘applicant, for’’, could not be executed because ‘‘appli- cant, for’’ does not appear. Subsecs. (b) to (e). Pub. L. 99–641, § 403(b)(6), tempo- rarily added subsecs. (b) to (e). See Effective and Ter- mination Dates of 1986 Amendment note below. Subsec. (f). Pub. L. 99–641, § 403(b)(3), temporarily des- ignated provisions which related to other provisions for withdrawal of inspection services as subsec. (f). See Ef- fective and Termination Dates of 1986 Amendment note below. Subsec. (g). Pub. L. 99–641, § 403(b)(4), temporarily des- ignated provisions which related to responsible connec- tion with business as subsec. (g). See Effective and Ter- mination Dates of 1986 Amendment note below. Subsec. (h). Pub. L. 99–641, § 403(b)(5), temporarily des- ignated provisions which related to finality of deter- mination by Secretary and to judicial review as subsec. (h), substituted ‘‘Except as provided in subsection (e)(2) of this section, the determination’’ for ‘‘The determina- tion’’ and ‘‘subsection (e) of this section’’ for ‘‘this sec- tion’’. See Effective and Termination Dates of 1986 Amendment note below. Statutory Notes and Related Subsidiaries EFFECTIVE AND TERMINATION DATES OF 1986 AMENDMENT Pub. L. 99–641, title IV, § 403(b), Nov. 10, 1986, 100 Stat. 3568, provided that the amendment made by that sec- tion is effective only during the 6-year period beginning Nov. 10, 1986. EFFECTIVE DATE Subchapter effective Dec. 15, 1967, see section 20 of Pub. L. 90–201, set out as a note under section 601 of this title. CONSTRUCTION AND EFFECT OF AMENDMENTS BY PUB. L. 99–641 For provisions relating to construction and effect of temporary amendments by section 403 of Pub. L. 99–641, see sections 403(e) and 404 of Pub. L. 99–641, set out as notes entitled ‘‘Inspection Services for Establishments Not Participating in Total Plant Quality-Control Pro- gram’’ and ‘‘Savings Provision’’, respectively, under section 609 of this title. § 672. Administrative detention; duration; pend- ing judicial proceedings; notification of gov- ernmental authorities; release Whenever any carcass, part of a carcass, meat or meat food product of cattle, sheep, swine, goats, horses, mules, or other equines, or any product exempted from the definition of a meat food product, or any dead, dying, disabled, or diseased cattle, sheep, swine, goat, or equine is found by any authorized representative of the Secretary upon any premises where it is held for purposes of, or during or after distribution in, commerce or otherwise subject to subchapter I or II of this chapter, and there is reason to be- lieve that any such article is adulterated or mis- branded and is capable of use as human food, or that it has not been inspected, in violation of the provisions of subchapter I of this chapter or of any other Federal law or the laws of any State or Territory, or the District of Columbia, or that such article or animal has been or is in- tended to be, distributed in violation of any such provisions, it may be detained by such rep-