21 U.S.C. § 350i — Protection against intentional adulteration

(a) Determinations: (1) The Secretary^* must (A) assess how vulnerable the food^* system is to intentional contamination, considering the Department^* of Homeland Security's terrorism risk assessments; (B) weigh the best available understanding of the uncertainties, risks, costs, and benefits of guarding vulnerable points; and (C) decide what science-based mitigation strategies are needed to protect against intentional adulteration. (2) For national security reasons, the Secretary, consulting Homeland Security, may decide the time, manner, and form in which these determinations are made public.

(b) Regulations: Within 18 months of January 4, 2011, the Secretary — coordinating with the Secretary of Homeland Security and consulting the Secretary of Agriculture — must issue regulations to protect against intentional food adulteration. These regulations must (1) explain how a person^* is to assess whether they must adopt mitigation strategies, and (2) specify appropriate science-based mitigation strategies to prepare and protect the food supply chain at specific vulnerable points.

(c) Applicability: These regulations apply only to food the Secretary decides, in consultation with Homeland Security, has a high risk of intentional contamination that could cause serious harm or death — specifically food (1) with clear identified vulnerabilities, such as a short shelf life or exposure at critical control points, and (2) that is still in bulk or batch form, not yet packaged for the final consumer.

(d) Exception: This section doesn't apply to farms, except farms that produce milk.

(e) Definition: "Farm" has the meaning given in 21 C.F.R. § 1.227, or any regulation that replaces it.