§350i — Title 21 Food and Drugs | U.S. Code

Summary

The Secretary must check the food system for weak spots where someone could intentionally contaminate food. The Secretary must use Homeland Security risk work, weigh uncertainties, risks, costs, and benefits, and decide what science-based steps are needed to prevent contamination. For national security, the Secretary and Homeland Security can choose how and when to make these findings public. Within 18 months after January 4, 2011, the Secretary, working with Homeland Security and consulting Agriculture, must create rules to protect food from intentional contamination. The rules must tell people how to decide if they need to use prevention steps and must list appropriate science-based measures to guard vulnerable points. The rules only cover foods judged high-risk by the Secretary and Homeland Security — ones that could cause serious illness or death, have clear vulnerabilities (like short shelf life or weak control points), or are in bulk or batch form before final packaging. Farms are not covered except those that produce milk. “Farm” means the term in 21 CFR 1.227 (or any successor regulation).

Title 21, §350i

Food and Drugs — Source: USLM XML via OLRC

(a)(1)The Secretary shall—

(A)conduct a vulnerability assessment of the food system, including by consideration of the Department of Homeland Security biological, chemical, radiological, or other terrorism risk assessments;

(B)consider the best available understanding of uncertainties, risks, costs, and benefits associated with guarding against intentional adulteration of food at vulnerable points; and

(C)determine the types of science-based mitigation strategies or measures that are necessary to protect against the intentional adulteration of food.

(2)In the interest of national security, the Secretary, in consultation with the Secretary of Homeland Security, may determine the time, manner, and form in which determinations made under paragraph (1) are made publicly available.

(b)Not later than 18 months after January 4, 2011, the Secretary, in coordination with the Secretary of Homeland Security and in consultation with the Secretary of Agriculture, shall promulgate regulations to protect against the intentional adulteration of food subject to this chapter. Such regulations shall—

(1)specify how a person shall assess whether the person is required to implement mitigation strategies or measures intended to protect against the intentional adulteration of food; and

(2)specify appropriate science-based mitigation strategies or measures to prepare and protect the food supply chain at specific vulnerable points, as appropriate.

(c)Regulations promulgated under subsection (b) shall apply only to food for which there is a high risk of intentional contamination, as determined by the Secretary, in consultation with the Secretary of Homeland Security, under subsection (a), that could cause serious adverse health consequences or death to humans or animals and shall include those foods—

(1)for which the Secretary has identified clear vulnerabilities (including short shelf-life or susceptibility to intentional contamination at critical control points); and

(2)in bulk or batch form, prior to being packaged for the final consumer.

(d)This section shall not apply to farms, except for those that produce milk.

(e)For purposes of this section, the term “farm” has the meaning given that term in section 1.227 of title 21, Code of Federal Regulations (or any successor regulation).

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Construction

Nothing in this section 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. Guidance Documents Pub. L. 111–353, title I, § 106(b), Jan. 4, 2011, 124 Stat. 3906, provided that: “(1) In general.—Not later than 1 year after the date of enactment of this Act [Jan. 4, 2011], the Secretary of Health and Human Services, in consultation with the Secretary of Homeland Security and the Secretary of Agriculture, shall issue guidance documents related to protection against the intentional adulteration of food, including mitigation strategies or measures to guard against such adulteration as required under section 420 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 450i], as added by subsection (a). “(2) Content.—The guidance documents issued under paragraph (1) shall—“(A) include a model assessment for a person to use under subsection (b)(1) of section 420 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a); “(B) include examples of mitigation strategies or measures described in subsection (b)(2) of such section; and “(C) specify situations in which the examples of mitigation strategies or measures described in subsection (b)(2) of such section are appropriate. “(3) Limited distribution.—In the interest of national security, the Secretary of Health and Human Services, in consultation with the Secretary of Homeland Security, may determine the time, manner, and form in which the guidance documents issued under paragraph (1) are made public, including by releasing such documents to targeted audiences.” Periodic Review Pub. L. 111–353, title I, § 106(c), Jan. 4, 2011, 124 Stat. 3906, provided that: “The Secretary of Health and Human Services shall periodically review and, as appropriate, update the

Regulations

under section 420(b) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 450i(b)], as added by subsection (a), and the guidance documents under subsection (b) [section 106(b) of Pub. L. 111–353, set out above].”

§350i Protection Against Intentional Adulteration