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

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; consider the best available understanding of uncertainties, risks, costs, and benefits associated with guarding against intentional adulteration of food at vulnerable points; and determine the types of science-based mitigation strategies or measures that are necessary to protect against the intentional adulteration of food. 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. 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 specify appropriate science-based mitigation strategies or measures to prepare and protect the food supply chain at specific vulnerable points, as appropriate. for which the Secretary has identified clear vulnerabilities (including short shelf-life or susceptibility to intentional contamination at critical control points); and in bulk or batch form, prior to being packaged for the final consumer. This section shall not apply to farms, except for those that produce milk. 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). 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). 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); include examples of mitigation strategies or measures described in subsection (b)(2) of such section; and specify situations in which the examples of mitigation strategies or measures described in subsection (b)(2) of such section are appropriate. 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.”