US Code
SUBCHAPTER IV— FOOD
§ 350i. Protection against intentional adulteration

(a) Determinations(1) In generalThe 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 distributionIn 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) RegulationsNot 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) ApplicabilityRegulations 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) ExceptionThis section shall not apply to farms, except for those that produce milk.
(e) DefinitionFor 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).

Structure US Code

US Code

Title 21— FOOD AND DRUGS

CHAPTER 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IV— FOOD

§ 341. Definitions and standards for food

§ 342. Adulterated food

§ 343. Misbranded food

§ 343–1. National uniform nutrition labeling

§ 343–2. Dietary supplement labeling exemptions

§ 343–3. Disclosure

§ 343a. Repealed. , , , 2763A–73

§ 344. Emergency permit control

§ 345. Regulations making exemptions

§ 346. Tolerances for poisonous or deleterious substances in food; regulations

§ 346a. Tolerances and exemptions for pesticide chemical residues

§ 346b. Authorization of appropriations

§ 347. Intrastate sales of colored oleomargarine

§ 347a. Congressional declaration of policy regarding oleomargarine sales

§ 347b. Contravention of State laws

§ 348. Food additives

§ 349. Bottled drinking water standards; publication in Federal Register

§ 350. Vitamins and minerals

§ 350a. Infant formulas

§ 350a–1. Protecting infants and improving formula supply

§ 350b. New dietary ingredients

§ 350c. Maintenance and inspection of records

§ 350d. Registration of food facilities

§ 350e. Sanitary transportation practices

§ 350f. Reportable food registry

§ 350g. Hazard analysis and risk-based preventive controls

§ 350h. Standards for produce safety

§ 350i. Protection against intentional adulteration

§ 350j. Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report

§ 350k. Laboratory accreditation for analyses of foods

§ 350l. Mandatory recall authority

§ 350l–1. Annual report to Congress

§ 350m. Requirements for critical food