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21 U.S.C. § 350m — Requirements for critical food
Federal law — U.S. Code and appendices · legal_authorities
**(a) Notification of meaningful disruption for critical food**
(1) **In general** — A manufacturer of a critical food (as defined in [section 321(ss) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section321/ss&num=0&edition=prelim)) shall notify the Secretary of a permanent discontinuance in the manufacture or an interruption of the manufacture of such food that is likely to lead to a meaningful disruption in the supply of such food in the United States, and the reasons for such discontinuance or interruption, as soon as practicable, but not later than 5 business days after such discontinuance or such interruption.
(2) **Distribution of information** — Not later than 5 calendar days after receiving a notification under paragraph (1), if the Secretary has determined that such discontinuance or interruption has resulted, or is likely to result, in a shortage of such critical food, the Secretary shall distribute, to the Secretary of Agriculture and to the maximum extent practicable to the appropriate entities, as determined by the Secretary through such means as the Secretary determines appropriate, information on such shortage.
(3) **Confidentiality** — Nothing in this subsection authorizes the Secretary to disclose any information that is a trade secret or confidential information subject to [section 552(b)(4) of title 5](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552/b/4&num=0&edition=prelim) or [section 1905 of title 18](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title18-section1905&num=0&edition=prelim).
(4) **Meaningful disruption** — In this subsection, the term “meaningful disruption”—
(A) means a change in production that is reasonably likely to lead to a significant re
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Source location: Title 21, Chapter 9, § 350m; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(a) Notification of meaningful disruption for critical food**
(1) **In general** — A manufacturer of a critical food (as defined in [section 321(ss) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section321/ss&num=0&edition=prelim)) shall notify the Secretary of a permanent discontinuance in the manufacture or an interruption of the manufacture of such food that is likely to lead to a meaningful disruption in the supply of such food in the United States, and the reasons for such discontinuance or interruption, as soon as practicable, but not later than 5 business days after such discontinuance or such interruption.
(2) **Distribution of information** — Not later than 5 calendar days after receiving a notification under paragraph (1), if the Secretary has determined that such discontinuance or interruption has resulted, or is likely to result, in a shortage of such critical food, the Secretary shall distribute, to the Secretary of Agriculture and to the maximum extent practicable to the appropriate entities, as determined by the Secretary through such means as the Secretary determines appropriate, information on such shortage.
(3) **Confidentiality** — Nothing in this subsection authorizes the Secretary to disclose any information that is a trade secret or confidential information subject to [section 552(b)(4) of title 5](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552/b/4&num=0&edition=prelim) or [section 1905 of title 18](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title18-section1905&num=0&edition=prelim).
(4) **Meaningful disruption** — In this subsection, the term “meaningful disruption”—
(A) means a change in production that is reasonably likely to lead to a significant reduction in the supply of a critical food by a manufacturer that affects the ability of the manufacturer to meet expected demand for its product; and
(B) does not include interruptions in manufacturing due to matters such as routine maintenance, changes or discontinuance of flavors, colors, or other insignificant formulation characteristics, or insignificant changes in manufacturing so long as the manufacturer expects to resume operations in a short period of time.
**(b) Risk management plans** Each manufacturer of a critical food shall develop, maintain, and implement, as appropriate, a redundancy risk management plan that identifies and evaluates risks to the supply of the food, as applicable, for each establishment in which such food is manufactured. A risk management plan under this subsection—
(1) may identify and evaluate risks to the supply of more than one critical food, or critical food category, manufactured at the same establishment;
(2) may identify mechanisms by which the manufacturer would mitigate the impacts of a supply disruption through alternative production sites, alternative suppliers, stockpiling of inventory, or other means; and
(3) shall be subject to inspection and copying by the Secretary pursuant to an inspection under [section 374 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section374&num=0&edition=prelim).
**(c) Failure to meet requirements**
(1) **In general** — If a person fails to submit information required under, and in accordance with, subsection (a)—
(A) the Secretary shall issue a letter to such person informing such person of such failure; and
(B) not later than 45 calendar days after the issuance of a letter under subparagraph (A), subject to paragraph (2), the Secretary shall make available to the public on the website of the Food and Drug Administration, with appropriate redactions made to protect the information described in subsection (a)(3)—
(i) the letter issued under subparagraph (A); and
(ii) at the request of such person, any response to such letter such person submitted to the Secretary.
(2) **Exception** — If the Secretary determines that the letter under paragraph (1) was issued in error or, after review of such response, the person had a reasonable basis for not submitting a notification as required under subsection (a), the requirements of paragraph (1)(B) shall not apply.
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Federal law — U.S. Code and appendices · legal_authorities
Whoever, being an officer or employee of the United States or of any department or agency thereof, any person acting on behalf of the Federal Housing Finance Agency, or agent of the Department of Justice as defined in the Antitrust Civil Process Act ([15 U.S.C. 1311–131](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1311–131&num=0&edition=prelim)4), or being an employee of a private sector organization who is or was assigned to an agency under chapter 37 of title 5, publishes, divulges, discloses, or makes known in any manner or to any extent not authorized by law any information coming to him in the course of his employment or official duties or by reason of any examination or investigation made by, or return, report or record made to or filed with, such department or agency or officer or employee thereof, which information concerns or relates to the trade secrets, processes, operations, style of work, or apparatus, or to the identity, confidential statistical data, amount or source of any income, profits, losses, or expenditures of any person, firm, partnership, corporation, or association; or permits any income return or copy thereof or any book containing any abstract or particulars thereof to be seen or examined by any person except as provided by law; shall be fined under this title, or imprisoned not more than one year, or both; and shall be removed from office or employment.
Source: Supplied U.S. Code snapshot — release unconfirmed · 18 U.S.C. § 1905
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Right of agents to enter; scope of inspection; notice; promptness; exclusions**
(1) For purposes of enforcement of this chapter, officers or employees duly designated by the Secretary, upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge, are authorized (A) to enter, at reasonable times, any factory, warehouse, or establishment in which food, drugs, devices, tobacco products, or cosmetics are manufactured, processed, packed, or held, for introduction into interstate commerce or after such introduction, or to enter any vehicle being used to transport or hold such food, drugs, devices, tobacco products, or cosmetics in interstate commerce; and (B) to inspect, at reasonable times and within reasonable limits and in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling therein. In the case of any person (excluding farms and restaurants) who manufactures, processes, packs, transports, distributes, holds, or imports foods, the inspection shall extend to all records and other information described in [section 350c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350c&num=0&edition=prelim), when the standard for records inspection under paragraph (1) or (2) of [section 350c(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350c/a&num=0&edition=prelim) applies, subject to the limitations established in [section 350c(d) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350c/d&num=0&edition=prelim). In the case of a facility (as defined in [section 364 of this title](https://uscode.house.gov/vi
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 374
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Definitions**
(1) **In general** — In this section, the term “infant formula” has the meaning given such term in section 201(z) of the Federal Food, Drug, and Cosmetic Act ([21 U.S.C. 321(z)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section321/z&num=0&edition=prelim)).
(2) **Omitted**
**(b) Office of Critical Foods**
(1) **In general** — The Secretary shall establish within the Center for Food Safety and Applied Nutrition an office to be known as the Office of Critical Foods. The Secretary shall appoint a Director to lead such Office.
(2) **Duties** — The Office of Critical Foods shall be responsible for oversight, coordination, and facilitation of activities related to critical foods, as defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 321(ss)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section321/ss&num=0&edition=prelim)], as added by subsection (a)(2).
**(c) Omitted**
**(d) Report** Not later than one year after December 29, 2022, the Secretary shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives that includes—
(1) the number of premarket submissions for new infant formula the Secretary has received under section 412(d) of the Federal Food, Drug, and Cosmetic Act ([21 U.S.C. 350a(d)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350a/d&num=0&edition=prelim)) each year since 2012;
(2) how many of such submissions received requests from the Secretary for additional information;
(3) how long after receiving such submissions the Secretary sent such requests for additional information;
(4) what additional information the Secre
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 350a–1
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Federal law — U.S. Code and appendices · legal_authorities
Page 155
TITLE 21—FOOD AND DRUGS
§ 351
tion of an article of food that was the subject
of a recall under section 350l(b) of this title or
a public health advisory described in para-
graph (1).
(Pub. L. 111–353, title II, § 206(f), Jan. 4, 2011, 124
Stat. 3943.)
Editorial Notes
REFERENCES IN TEXT
Subsection (a), referred to in par. (1), means subsec.
(a) of section 206 of Pub. L. 111–353.
CODIFICATION
Section was enacted as part of the FDA Food Safety
Modernization Act, and not as part of the Federal
Food, Drug, and Cosmetic Act which comprises this
chapter.
Statutory Notes and Related Subsidiaries
CONSTRUCTION
Nothing in this section to be construed to alter juris-
diction 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 2251 and 2252 of this title.
§ 350m. Requirements for critical food
(a) Notification of meaningful disruption for crit-
ical food
(1) In general
A manufacturer of a critical food (as defined
in section 321(ss) of this title) shall notify the
Secretary of a permanent discontinuance in
the manufacture or an interruption of the
manufacture of such food that is likely to lead
to a meaningful disruption in the supply of
such food in the United States, and the rea-
sons for such discontinuance or interruption,
as soon as practicable, but not later than 5
business days after such discontinuance or
such interruption.
(2) Distribution of information
Not later than 5 calendar days after receiv-
ing a notification under paragraph (1), if the
Secretary has determined that such dis-
continuance or interruption has resulted, or is
likely to result, in a shortage of such critical
food, the Secretary shall distribute, to t
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 350m
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