Page:United States Statutes at Large Volume 124.djvu/3957

 124 STAT. 3931 PUBLIC LAW 111–353—JAN. 4, 2011 (A) evaluate domestic and international product tracing practices in commercial use; (B) consider international efforts, including an assess- ment of whether product tracing requirements developed under this section are compatible with global tracing sys- tems, as appropriate; and (C) consult with a diverse and broad range of experts and stakeholders, including representatives of the food industry, agricultural producers, and nongovernmental organizations that represent the interests of consumers. (c) PRODUCT TRACING SYSTEM.—The Secretary, in consultation with the Secretary of Agriculture, shall, as appropriate, establish within the Food and Drug Administration a product tracing system to receive information that improves the capacity of the Secretary to effectively and rapidly track and trace food that is in the United States or offered for import into the United States. Prior to the establishment of such product tracing system, the Secretary shall examine the results of applicable pilot projects and shall ensure that the activities of such system are adequately supported by the results of such pilot projects. (d) ADDITIONAL RECORDKEEPING REQUIREMENTS FOR HIGH RISK FOODS.— (1) IN GENERAL.—In order to rapidly and effectively identify recipients of a food to prevent or mitigate a foodborne illness outbreak and to address credible threats of serious adverse health consequences or death to humans or animals as a result of such food being adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act or misbranded under section 403(w) of such Act, not later than 2 years after the date of enactment of this Act, the Secretary shall publish a notice of proposed rulemaking to establish recordkeeping require- ments, in addition to the requirements under section 414 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350c) and subpart J of part 1 of title 21, Code of Federal Regulations (or any successor regulations), for facilities that manufacture, process, pack, or hold foods that the Secretary designates under paragraph (2) as high-risk foods. The Secretary shall set an appropriate effective date of such additional requirements for foods designated as high risk that takes into account the length of time necessary to comply with such requirements. Such requirements shall— (A) relate only to information that is reasonably avail- able and appropriate; (B) be science-based; (C) not prescribe specific technologies for the mainte- nance of records; (D) ensure that the public health benefits of imposing additional recordkeeping requirements outweigh the cost of compliance with such requirements; (E) be scale-appropriate and practicable for facilities of varying sizes and capabilities with respect to costs and recordkeeping burdens, and not require the creation and maintenance of duplicate records where the information is contained in other company records kept in the normal course of business; Deadline. Publication. Notice. Consultation.