Page:United States Statutes at Large Volume 124.djvu/3961

 124 STAT. 3935 PUBLIC LAW 111–353—JAN. 4, 2011 manufactures, processes, packs, or holds such food, is required to register with the Secretary under section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d) with respect to the manufacturing, processing, packing, or holding of the applicable food, the Secretary shall require such person to maintain records that identify the immediate previous source of such food and the imme- diate subsequent recipient of such food. (G) GROCERY STORES.—With respect to a sale of a food described in subparagraph (H) to a grocery store, the Secretary shall not require such grocery store to main- tain records under this subsection other than records docu- menting the farm that was the source of such food. The Secretary shall not require that such records be kept for more than 180 days. (H) FARM SALES TO CONSUMERS.—The Secretary shall not require a farm to maintain any distribution records under this subsection with respect to a sale of a food described in subparagraph (I) (including a sale of a food that is produced and packaged on such farm), if such sale is made by the farm directly to a consumer. (I) SALE OF A FOOD.—A sale of a food described in this subparagraph is a sale of a food in which— (i) the food is produced on a farm; and (ii) the sale is made by the owner, operator, or agent in charge of such farm directly to a consumer or grocery store. (7) NO IMPACT ON NON-HIGH-RISK FOODS.—The record- keeping requirements established under paragraph (1) shall have no effect on foods that are not designated by the Secretary under paragraph (2) as high-risk foods. Foods described in the preceding sentence shall be subject solely to the record- keeping 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). (e) EVALUATION AND RECOMMENDATIONS.— (1) REPORT.—Not later than 1 year after the effective date of the final rule promulgated under subsection (d)(1), the Comp- troller General of the United States shall submit to Congress a report, taking into consideration the costs of compliance and other regulatory burdens on small businesses and Federal, State, and local food safety practices and requirements, that evaluates the public health benefits and risks, if any, of lim- iting— (A) the product tracing requirements under subsection (d) to foods identified under paragraph (2) of such sub- section, including whether such requirements provide ade- quate assurance of traceability in the event of intentional adulteration, including by acts of terrorism; and (B) the participation of restaurants in the record- keeping requirements. (2) DETERMINATION AND RECOMMENDATIONS.—In con- ducting the evaluation and report under paragraph (1), if the Comptroller General of the United States determines that the limitations described in such paragraph do not adequately pro- tect the public health, the Comptroller General shall submit Time period.