21 U.S.C. § 350m — Requirements for critical food

submitted 88 years ago by Pub. L. 117-328 to r/title-21-FOOD-AND-DRUGS · 585 words · no verdicts yet

in plain englishAI-generated · not legal advice

Manufacturers of "critical food" must tell the FDA about production stops likely to cause a supply shortage. They must also keep a written plan for managing supply risks at each factory. If a manufacturer fails to notify the FDA, the FDA can publish that failure publicly.

(a) A manufacturer of a "critical food" must tell the Secretary about certain changes. This includes any permanent stop in making the food. It also includes any interruption in making the food. The manufacturer must give notice only if the change is likely to cause a "meaningful disruption" in the food's supply. The manufacturer must notify the Secretary within 5 business days. The manufacturer must also explain the reason for the change. Suppose the Secretary decides a shortage is likely. Then the Secretary must share information about it. This information goes to the Department of Agriculture. It also goes to other appropriate groups, within 5 days. This section does not let the Secretary disclose trade secrets. It also does not allow disclosure of other confidential business information. A "meaningful disruption" means a production change. This change is likely to significantly cut supply. It must affect the manufacturer's ability to meet expected demand. This term does not include routine maintenance. It also does not include minor formula changes, if production resumes quickly.

(b) Each manufacturer of a critical food must create a redundancy risk management plan. The manufacturer must maintain and follow this plan for each place where it makes the food. The plan identifies and evaluates supply risks. One plan may cover more than one critical food made at the same site. The plan may describe backup measures. These include alternate factories, alternate suppliers, or extra inventory. The Secretary may inspect and copy this plan during a regular inspection.

(c) Suppose a manufacturer fails to submit the required notice. Then the Secretary must send a letter explaining the failure. Within 45 days after that letter, the Secretary must generally publish the letter online. Confidential information gets redacted first. The Secretary must also publish the manufacturer's response, if the manufacturer asks. This publication is not required in two cases: if the Secretary decides the letter was an error, or if the manufacturer had a reasonable basis for not reporting.

facts

- Codified at 21 U.S.C. § 350m, titled "Requirements for critical food," part of the Federal Food, Drug, and Cosmetic Act. - Originally enacted as § 424 of the Act of June 25, 1938, ch. 675, and added by Pub. L. 117–328, div. FF, title III, § 3401(k), Dec. 29, 2022, 136 Stat. 5844. - Contains a single source-credit reference reflecting one amendment (its addition in 2022). - The statute spans 585 words and is organized into three subsections: (a) notification requirements, (b) risk management plans, and (c) failure to meet requirements.

the actual law source: uscode.house.gov ↗public domain

(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) 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 or section 1905 of title 18.

(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.

(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.

Source credit: (June 25, 1938, ch. 675, § 424, as added Pub. L. 117–328, div. FF, title III, § 3401(k), Dec. 29, 2022, 136 Stat. 5844.)

history & why it existsrecord from the source credit

1938Enacted · Pub. L. 117-328 · 136 Stat. 5844

The record. According to the source credit, this section was enacted as § 424 of the Federal Food, Drug, and Cosmetic Act (act of June 25, 1938, ch. 675), added by Public Law 117-328, Division FF, Title III, § 3401(k), enacted December 29, 2022, and published at 136 Stat. 5844. The source credit reflects only this single enactment, with no subsequent amendments noted. Historical context. Public Law 117-328 was the Consolidated Appropriations Act, 2023, a large year-end omnibus spending measure that included, in Division FF, an assortment of food and drug policy provisions commonly referred to as the Food and Drug Omnibus Reform Act. The addition of a critical-food notification and risk-management framework is generally understood to reflect congressional concern, heightened in 2022, about disruptions to the supply of essential foods—most notably infant formula, following a major manufacturing shutdown and recall that produced a well-publicized nationwide shortage that year. The commonly cited purpose of provisions like this one was to give the Food and Drug Administration earlier warning of supply interruptions in critical foods and to encourage manufacturers to plan for redundancy, so that shortages could be anticipated and mitigated. Beyond this general legislative and historical backdrop, the record does not establish the specific deliberations or rationale Congress applied to the particular terms of this section.

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