Page:United States Statutes at Large Volume 124.djvu/3927

 124 STAT. 3901 PUBLIC LAW 111–353—JAN. 4, 2011 based on known risks which may include a history and severity of foodborne illness outbreaks. ‘‘(b) FINAL REGULATION.— ‘‘(1) IN GENERAL.—Not later than 1 year after the close of the comment period for the proposed rulemaking under sub- section (a), the Secretary shall adopt a final regulation to provide for minimum science-based standards for those types of fruits and vegetables, including specific mixes or categories of fruits or vegetables, that are raw agricultural commodities, based on known safety risks, which may include a history of foodborne illness outbreaks. ‘‘(2) FINAL REGULATION.—The final regulation shall— ‘‘(A) provide for coordination of education and enforce- ment activities by State and local officials, as designated by the Governors of the respective States or the appropriate elected State official as recognized by State statute; and ‘‘(B) include a description of the variance process under subsection (c) and the types of permissible variances the Secretary may grant. ‘‘(3) FLEXIBILITY FOR SMALL BUSINESSES.—Notwithstanding paragraph (1)— ‘‘(A) the regulations promulgated under this section shall apply to a small business (as defined in the regulation promulgated under subsection (a)(1)) after the date that is 1 year after the effective date of the final regulation under paragraph (1); and ‘‘(B) the regulations promulgated under this section shall apply to a very small business (as defined in the regulation promulgated under subsection (a)(1)) after the date that is 2 years after the effective date of the final regulation under paragraph (1). ‘‘(c) CRITERIA.— ‘‘(1) IN GENERAL.—The regulations adopted under sub- section (b) shall— ‘‘(A) set forth those procedures, processes, and practices that the Secretary determines to minimize the risk of serious adverse health consequences or death, including procedures, processes, and practices that the Secretary determines to be reasonably necessary to prevent the introduction of known or reasonably foreseeable biological, chemical, and physical hazards, including hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced, including by acts of terrorism, into fruits and vegetables, including specific mixes or cat- egories of fruits and vegetables, that are raw agricultural commodities and to provide reasonable assurances that the produce is not adulterated under section 402; ‘‘(B) provide sufficient flexibility to be practicable for all sizes and types of businesses, including small businesses such as a small food processing facility co-located on a farm; ‘‘(C) comply with chapter 35 of title 44, United States Code (commonly known as the ‘Paperwork Reduction Act’), with special attention to minimizing the burden (as defined in section 3502(2) of such Act) on the business, and collec- tion of information (as defined in section 3502(3) of such Act), associated with such regulations; Applicability. Effective dates. Deadline.