21 U.S.C. § 350i Protection Against Intentional Adulteration

• Library: United States Statutes
• Edition: 2023
• Currency: Current through P.L. 118-34 (published on www.congress.gov on 12/26/2023), except for [P. L. 118-31]
• Year: 2023
• Citation: 21 U.S.C. § 350i

(a) Determinations

(1) In general

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) Limited distribution

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) Regulations

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) Applicability

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) Exception

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

(e) Definition

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).

Cite as 21 U.S.C. § 350i