124 STAT. 3895 PUBLIC LAW 111–353—JAN. 4, 2011 food was manufactured or processed, on a label, poster, sign, placard, or documents delivered contempora- neously with the food in the normal course of business, or, in the case of Internet sales, in an electronic notice. ‘‘(B) NO ADDITIONAL LABEL.—Subparagraph (A) does not provide authority to the Secretary to require a label that is in addition to any label required under any other provision of this Act. ‘‘(m) AUTHORITY WITH RESPECT TO CERTAIN FACILITIES.—The Secretary may, by regulation, exempt or modify the requirements for compliance under this section with respect to facilities that are solely engaged in the production of food for animals other than man, the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or proc- essing, or the storage of packaged foods that are not exposed to the environment. ‘‘(n) REGULATIONS.— ‘‘(1) IN GENERAL.—Not later than 18 months after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall promulgate regulations— ‘‘(A) to establish science-based minimum standards for conducting a hazard analysis, documenting hazards, imple- menting preventive controls, and documenting the implementation of the preventive controls under this sec- tion; and ‘‘(B) to define, for purposes of this section, the terms ‘small business’ and ‘very small business’, taking into consideration the study described in subsection (l)(5). ‘‘(2) COORDINATION.—In promulgating the regulations under paragraph (1)(A), with regard to hazards that may be intentionally introduced, including by acts of terrorism, the Secretary shall coordinate with the Secretary of Homeland Security, as appropriate. ‘‘(3) CONTENT.—The regulations promulgated under para- graph (1)(A) shall— ‘‘(A) provide sufficient flexibility to be practicable for all sizes and types of facilities, including small businesses such as a small food processing facility co-located on a farm; ‘‘(B) 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 facility, and collection of information (as defined in section 3502(3) of such Act), associated with such regulations; ‘‘(C) acknowledge differences in risk and minimize, as appropriate, the number of separate standards that apply to separate foods; and ‘‘(D) not require a facility to hire a consultant or other third party to identify, implement, certify, or audit preventative controls, except in the case of negotiated enforcement resolutions that may require such a consultant or third party. ‘‘(4) RULE OF CONSTRUCTION.—Nothing in this subsection shall be construed to provide the Secretary with the authority to prescribe specific technologies, practices, or critical controls for an individual facility. Deadline.
