124 STAT. 3905 PUBLIC LAW 111–353—JAN. 4, 2011 ‘‘(vv) The failure to comply with the requirements under section 419.’’. (d) NO EFFECT ON HACCP AUTHORITIES.—Nothing in the amendments made by this section limits the authority of the Sec- retary under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public Health Service Act (42 U.S.C. 201 et seq.) to revise, issue, or enforce product and category-specific regula- tions, such as the Seafood Hazard Analysis Critical Controls Points Program, the Juice Hazard Analysis Critical Control Program, and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards. SEC. 106. PROTECTION AGAINST INTENTIONAL ADULTERATION. (a) IN GENERAL.—Chapter IV (21 U.S.C. 341 et seq.), as amended by section 105, is amended by adding at the end the following: ‘‘SEC. 420. PROTECTION AGAINST INTENTIONAL ADULTERATION. ‘‘(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 vulner- able 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 the date of enactment of the FDA Food Safety Modernization Act, the Sec- retary, in coordination with the Secretary of Homeland Security and in consultation with the Secretary of Agriculture, shall promul- gate regulations to protect against the intentional adulteration of food subject to this Act. 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 con- sultation 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 Deadline. Determination. 21 USC 350i. 21 USC 350h note.
