21 USC 350m - Requirements for critical food

U.S Code last checked for updates: May 21, 2025

§ 350m.

Requirements for critical food

(a)

Notification of meaningful disruption for critical food

(1)

In general

(2)

Distribution of information

(3)

Confidentiality

(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.

(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

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

cite as: 21 USC 350m