Records inspection
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 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.
Use of or exposure to food of concern
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.
Application
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.
Regulations concerning recordkeeping
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.
Protection of sensitive information
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.
Limitations
June 25, 1938, ch. 675, § 414Pub. L. 107–188, title III, § 306(a)116 Stat. 669Pub. L. 111–353, title I, § 101(a)124 Stat. 3886(, as added , , ; amended , , .)
Editorial Notes
References in Text
act Mar. 4, 1907, ch. 2907Pub. L. 90–20181 Stat. 584Pub. L. 110–246, title XI, § 11015(a)122 Stat. 2124section 601 of this titleThe Federal Meat Inspection Act, referred to in subsec. (d)(2), is titles I to V of , as added , , , and , , , 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 and Tables.
Pub. L. 85–17271 Stat. 441section 451 of this titleThe Poultry Products Inspection Act, referred to in subsec. (d)(2), is , , , 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 and Tables.
Pub. L. 91–59784 Stat. 1620section 1031 of this titleThe Egg Products Inspection Act, referred to in subsec. (d)(2), is , , , 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 and Tables.
Amendments
Pub. L. 111–3532011—Subsec. (a). 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)116 Stat. 670
Construction of 2011 Amendment
Pub. L. 111–353Nothing in amendment by 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 sections 2206, 2251, and 2252 of this title.