21 U.S.C. § 350c — Maintenance and inspection of records

Page 133 TITLE 21—FOOD AND DRUGS § 350c be expected to be safe because the article may be, or may contain, an anabolic steroid or an analogue of an anabolic steroid, the Secretary shall notify the Drug Enforcement Adminis- tration of such determination. Such notifica- tion by the Secretary shall include, at a min- imum, the name of the dietary supplement or article, the name of the person or persons who marketed the product or made the submission of information regarding the article to the Secretary under this section, and any contact information for such person or persons that the Secretary has. (2) Definitions For purposes of this subsection— (A) the term ‘‘anabolic steroid’’ has the meaning given such term in section 802(41) of this title; and (B) the term ‘‘analogue of an anabolic ster- oid’’ means a substance whose chemical structure is substantially similar to the chemical structure of an anabolic steroid. (d) ‘‘New dietary ingredient’’ defined For purposes of this section, the term ‘‘new di- etary ingredient’’ means a dietary ingredient that was not marketed in the United States be- fore October 15, 1994 and does not include any di- etary ingredient which was marketed in the United States before October 15, 1994. (June 25, 1938, ch. 675, § 413, as added Pub. L. 103–417, § 8, Oct. 25, 1994, 108 Stat. 4331; amended Pub. L. 111–353, title I, § 113(a), Jan. 4, 2011, 124 Stat. 3920.) Editorial Notes AMENDMENTS 2011—Subsecs. (c), (d). Pub. L. 111–353 added subsec. (c) and redesignated former subsec. (c) as (d). Statutory Notes and Related Subsidiaries GUIDANCE Pub. L. 111–353, title I, § 113(b), Jan. 4, 2011, 124 Stat. 3921, provided that: ‘‘Not later than 180 days after the date of enactment of this Act [Jan. 4, 2011], the Sec- retary shall publish guidance that clarifies when a die- tary supplement ingredient is a new dietary ingredient, when the manufacturer or distributor of a dietary in- gredient or dietary supplement should provide the Sec- retary with information as described in section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350b(a)(2)], the evidence needed to document the safety of new dietary ingredients, and appropriate methods for establishing the identify [sic] of a new dietary ingre- dient.’’ CONSTRUCTION OF 2011 AMENDMENT Nothing in amendment by Pub. L. 111–353 to be con- strued to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under cer- tain other Acts, or in a manner inconsistent with inter- national agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title. § 350c. Maintenance and inspection of records (a) Records inspection (1) Adulterated food If the Secretary has a reasonable belief that an article of food, and any other article of food that the Secretary reasonably believes is like- ly to be affected in a similar manner, is adul- terated and presents a threat of serious ad- verse health consequences or death to humans or animals, each person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports such article shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presen- tation of appropriate credentials and a written notice to such person, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to such article, and to any other arti- cle of food that the Secretary reasonably be- lieves is likely to be affected in a similar man- ner, that are needed to assist the Secretary in determining whether the food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals. (2) Use of or exposure to food of concern If the Secretary believes that there is a rea- sonable probability that the use of or exposure to an article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals, each person (ex- cluding farms and restaurants) who manufac- tures, processes, packs, distributes, receives, holds, or imports such article shall, at the re- quest of an officer or employee duly des- ignated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials and a written notice to such per- son, at reasonable times and within reasonable limits and in a reasonable manner, to have ac- cess to and copy all records relating to such article and to any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, that are need- ed to assist the Secretary in determining whether there is a reasonable probability that the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals. (3) Application The requirement under paragraphs (1) and (2) applies to all records relating to the manufac- ture, processing, packing, distribution, re- ceipt, holding, or importation of such article maintained by or on behalf of such person in any format (including paper and electronic formats) and at any location. (b) Regulations concerning recordkeeping The Secretary, in consultation and coordina- tion, as appropriate, with other Federal depart- ments and agencies with responsibilities for reg- ulating food safety, may by regulation establish requirements regarding the establishment and maintenance, for not longer than two years, of records by persons (excluding farms and res- taurants) who manufacture, process, pack, transport, distribute, receive, hold, or import food, which records are needed by the Secretary for inspection to allow the Secretary to identify the immediate previous sources and the imme- diate subsequent recipients of food, including its packaging, in order to address credible threats Page 134 TITLE 21—FOOD AND DRUGS § 350d of serious adverse health consequences or death to humans or animals. The Secretary shall take into account the size of a business in promul- gating regulations under this section. (c) Protection of sensitive information The Secretary shall take appropriate meas- ures to ensure that there are in effect effective procedures to prevent the unauthorized disclo- sure of any trade secret or confidential informa- tion that is obtained by the Secretary pursuant to this section. (d) Limitations This section shall not be construed— (1) to limit the authority of the Secretary to inspect records or to require establishment and maintenance of records under any other provision of this chapter; (2) to authorize the Secretary to impose any requirements with respect to a food to the ex- tent that it is within the exclusive jurisdic- tion of the Secretary of Agriculture pursuant to the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.); (3) to have any legal effect on section 552 of title 5 or section 1905 of title 18; or (4) to extend to recipes for food, financial data, pricing data, personnel data, research data, or sales data (other than shipment data regarding sales). (June 25, 1938, ch. 675, § 414, as added Pub. L. 107–188, title III, § 306(a), June 12, 2002, 116 Stat. 669; amended Pub. L. 111–353, title I, § 101(a), Jan. 4, 2011, 124 Stat. 3886.) Editorial Notes REFERENCES IN TEXT The Federal Meat Inspection Act, referred to in sub- sec. (d)(2), is titles I to V of act Mar. 4, 1907, ch. 2907, as added Pub. L. 90–201, Dec. 15, 1967, 81 Stat. 584, and Pub. L. 110–246, title XI, § 11015(a), June 18, 2008, 122 Stat. 2124, which are classified generally to subchapters I to IV–A (§ 601 et seq.) of chapter 12 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 601 of this title and Tables. The Poultry Products Inspection Act, referred to in subsec. (d)(2), is Pub. L. 85–172, Aug. 28, 1957, 71 Stat. 441, which is classified generally to chapter 10 (§ 451 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under sec- tion 451 of this title and Tables. The Egg Products Inspection Act, referred to in sub- sec. (d)(2), is Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to chapter 15 (§ 1031 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under sec- tion 1031 of this title and Tables. AMENDMENTS 2011—Subsec. (a). Pub. L. 111–353 reenacted heading without change, designated existing provisions as par. (1) and inserted heading, substituted ‘‘If the Secretary has a reasonable belief that an article of food, and any other article of food that the Secretary reasonably be- lieves is likely to be affected in a similar manner, is’’ for ‘‘If the Secretary has a reasonable belief that an ar- ticle of food is’’, inserted ‘‘, and to any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner,’’ after ‘‘relating to such article’’, struck out at end ‘‘The requirement under the preceding sentence applies to all records re- lating to the manufacture, processing, packing, dis- tribution, receipt, holding, or importation of such arti- cle maintained by or on behalf of such person in any format (including paper and electronic formats) and at any location.’’, and added pars. (2) and (3). Statutory Notes and Related Subsidiaries EXPEDITED RULEMAKING Pub. L. 107–188, title III, § 306(d), June 12, 2002, 116 Stat. 670, provided that: ‘‘Not later than 18 months after the date of the enactment of this Act [June 12, 2002], the Secretary shall promulgate proposed and final regulations establishing recordkeeping require- ments under subsection 414(b) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350c(b)] (as added by subsection (a)).’’ CONSTRUCTION OF 2011 AMENDMENT Nothing in amendment by Pub. L. 111–353 to be con- strued to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under cer- tain other Acts, or in a manner inconsistent with inter- national agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title. § 350d. Registration of food facilities (a) Registration (1) In general The Secretary shall by regulation require that any facility engaged in manufacturing, processing, packing, or holding food for con- sumption in the United States be registered with the Secretary. To be registered— (A) for a domestic facility, the owner, op- erator, or agent in charge of the facility shall submit a registration to the Secretary; and (B) for a foreign facility, the owner, oper- ator, or agent in charge of the facility shall submit a registration to the Secretary and shall include with the registration the name of the United States agent for the facility. (2) Registration An entity (referred to in this section as the ‘‘registrant’’) shall submit a registration under paragraph (1) to the Secretary con- taining information necessary to notify the Secretary of the name and address of each fa- cility at which, and all trade names under which, the registrant conducts business, the e- mail address for the contact person of the fa- cility or, in the case of a foreign facility, the United States agent for the facility, and, when determined necessary by the Secretary through guidance, the general food category (as identified under section 170.3 of title 21, Code of Federal Regulations, or any other food categories as determined appropriate by the Secretary, including by guidance) of any food manufactured, processed, packed, or held at such facility. The registration shall contain an assurance that the Secretary will be per- mitted to inspect such facility at the times and in the manner permitted by this chapter. The registrant shall notify the Secretary in a timely manner of changes to such informa- tion. (3) Biennial registration renewal During the period beginning on October 1 and ending on December 31 of each even-num-