Page:United States Statutes at Large Volume 124.djvu/3925

 124 STAT. 3899 PUBLIC LAW 111–353—JAN. 4, 2011 date that is 6 months after the effective date of such regulations; and (B) the amendments made by this section shall apply to a very small business (as defined in such regulations) beginning on the date that is 18 months after the effective date of such regulations. SEC. 104. PERFORMANCE STANDARDS. (a) IN GENERAL.—The Secretary shall, in coordination with the Secretary of Agriculture, not less frequently than every 2 years, review and evaluate relevant health data and other relevant information, including from toxicological and epidemiological studies and analyses, current Good Manufacturing Practices issued by the Secretary relating to food, and relevant recommendations of rel- evant advisory committees, including the Food Advisory Committee, to determine the most significant foodborne contaminants. (b) GUIDANCE DOCUMENTS AND REGULATIONS.—Based on the review and evaluation conducted under subsection (a), and when appropriate to reduce the risk of serious illness or death to humans or animals or to prevent adulteration of the food under section 402 of the Federal Food, Drug, or Cosmetic Act (21 U.S.C. 342) or to prevent the spread by food of communicable disease under section 361 of the Public Health Service Act (42 U.S.C. 264), the Secretary shall issue contaminant-specific and science-based guid- ance documents, including guidance documents regarding action levels, or regulations. Such guidance, including guidance regarding action levels, or regulations— (1) shall apply to products or product classes; (2) shall, where appropriate, differentiate between food for human consumption and food intended for consumption by ani- mals other than humans; and (3) shall not be written to be facility-specific. (c) NO DUPLICATION OF EFFORTS.—The Secretary shall coordi- nate with the Secretary of Agriculture to avoid issuing duplicative guidance on the same contaminants. (d) REVIEW.—The Secretary shall periodically review and revise, as appropriate, the guidance documents, including guidance docu- ments regarding action levels, or regulations promulgated under this section. SEC. 105. STANDARDS FOR PRODUCE SAFETY. (a) IN GENERAL.—Chapter IV (21 U.S.C. 341 et seq.), as amended by section 103, is amended by adding at the end the following: ‘‘SEC. 419. STANDARDS FOR PRODUCE SAFETY. ‘‘(a) PROPOSED RULEMAKING.— ‘‘(1) IN GENERAL.— ‘‘(A) RULEMAKING.—Not later than 1 year after the date of enactment of the FDA Food Safety Modernization Act, the Secretary, in coordination with the Secretary of Agriculture and representatives of State departments of agriculture (including with regard to the national organic program established under the Organic Foods Production Act of 1990), and in consultation with the Secretary of Homeland Security, shall publish a notice of proposed rule- making to establish science-based minimum standards for the safe production and harvesting of those types of fruits Deadline. Publication. Notice. 21 USC 350h. Applicability. Deadline. 21 USC 2201.