Title 21 — Food and DrugsRelease 119-73not60
§350c Maintenance and Inspection of Records
Title 21 › Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IV— FOOD › § 350c
Summary
Requires companies (not farms or restaurants) that make, process, pack, ship, receive, hold, or import food to let officials appointed by the Secretary see and copy records when the Secretary has a reasonable belief the food is contaminated or unsafe and could cause serious illness or death, or when there is a reasonable probability the food’s use or exposure will do so. The official must show ID and give written notice. Access must be at reasonable times, within reasonable limits, and can cover records in any format and at any location that are needed to decide if the food is dangerous. The Secretary may make rules, with other agencies as needed, that require these businesses to keep records for up to two years showing where food came from and where it went next, including packaging, and must consider business size when doing so. The Secretary must protect trade secrets and confidential information. The rules do not limit other inspection powers, do not apply to foods under the exclusive authority of the Secretary of Agriculture (meat, poultry, eggs), do not change federal open‑records or confidentiality laws, and do not require recipes, financial, pricing, personnel, research, or sales data (except shipment data).
Full Legal Text
Title 21, §350c
Food and Drugs — Source: USLM XML via OLRC
(a)(1)If the Secretary has a reasonable belief that an article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, is adulterated and presents a threat of serious adverse 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 presentation 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 article of food that the Secretary reasonably believes is likely to be affected in a similar manner, 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)If the Secretary believes that there is a reasonable 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 (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 presentation 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 article of food that the Secretary reasonably believes is likely to be affected in a similar manner, that are needed 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)The requirement under paragraphs (1) and (2) applies to all records relating to the manufacture, processing, packing, distribution, receipt, 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)The Secretary, in consultation and coordination, as appropriate, with other Federal departments and agencies with responsibilities for regulating 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 restaurants) 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 immediate subsequent recipients of food, including its packaging, in order to address credible threats of serious adverse health consequences or death to humans or animals. The Secretary shall take into account the size of a business in promulgating regulations under this section.
(c)The Secretary shall take appropriate measures to ensure that there are in effect effective procedures to prevent the unauthorized disclosure of any trade secret or confidential information that is obtained by the Secretary pursuant to this section.
(d)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 extent that it is within the exclusive jurisdiction 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).
Legislative History
Notes & Related Subsidiaries
Editorial Notes
References in Text
The Federal Meat Inspection Act, referred to in subsec. (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 section 451 of this title and Tables. The Egg Products Inspection Act, referred to in subsec. (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 section 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 believes is likely to be affected in a similar manner, is” for “If the Secretary has a reasonable belief that an article 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 relating to the manufacture, processing, packing, distribution, receipt, 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.”, 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 requirements 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 AmendmentNothing in amendment by Pub. L. 111–353 to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see section 2206, 2251, and 2252 of this title.
Reference
Citations & Metadata
Citation
21 U.S.C. § 350c
Title 21 — Food and Drugs
Last Updated
Apr 5, 2026
Release point: 119-73not60