MAINTENANCE AND INSPECTION OF RECORDS FOR FOODS.

SEC. 306. MAINTENANCE AND INSPECTION OF RECORDS FOR FOODS. (a) In General.—Chapter IV of the Federal Food, Drug, and Cosmetic Act, as amended by section 305 of this Act, is amended by inserting before section 415 the following section: “SEC. 414. MAINTENANCE AND INSPECTION OF RECORDS. “(a) Records Inspection.—If the Secretary has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, each person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports such article shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials and a written notice to such person, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to such article that are needed to assist the Secretary in determining whether the food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals. The requirement under the preceding sentence applies to all records relating to the manufacture, processing, packing, distribution, receipt, holding, or importation of such article maintained by or on behalf of such person in any format (including paper and electronic formats) and at any location. “(b) Regulations Concerning Recordkeeping.—The Secretary, in consultation and coordination, as appropriate, with other Federal departments and agencies with responsibilities for regulating food safety, may by regulation establish requirements regarding the establishment and maintenance, for not longer than two years, of records by persons (excluding farms and restaurants) who manufacture, process, pack, transport, distribute, receive, hold, or import food, which records are needed by the Secretary for inspection to allow the Secretary to identify the immediate previous sources and the immediate subsequent recipients of food, including its packaging, in order to address credible threats of serious adverse health consequences or death to humans or animals. The Secretary shall take into account the size of a business in promulgating regulations under this section. “(c) Protection of Sensitive Information.—The Secretary shall take appropriate measures to ensure that there are in effect effective procedures to prevent the unauthorized disclosure of any trade secret or confidential information that is obtained by the Secretary pursuant to this section.116 STAT. 670 “(d) Limitations.—This section shall not be construed— “(1) to limit the authority of the Secretary to inspect records or to require establishment and maintenance of records under any other provision of this Act; “(2) to authorize the Secretary to impose any requirements with respect to a food to the extent that it is within the exclusive jurisdiction of the Secretary of Agriculture pursuant to the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.); “(3) to have any legal effect on section 552 of title 5, United States Code, or section 1905 of title 18, United States Code; or “(4) to extend to recipes for food, financial data, pricing data, personnel data, research data, or sales data (other than shipment data regarding sales).”. (b) Factory Inspection.—Section 704(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)) is amended— (1) in paragraph (1), by inserting after the first sentence the following new sentence: “In the case of any person (excluding farms and restaurants) who manufactures, processes, packs, transports, distributes, holds, or imports foods, the inspection shall extend to all records and other information described in section 414 when the Secretary has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, subject to the limitations established in section 414(d).”; and (2) in paragraph (2), in the matter preceding subparagraph (A), by striking “second sentence” and inserting “third sentence”. (c) Prohibited Act.—Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended— (1) in paragraph (e)— (A) by striking “by section 412, 504, or 703” and inserting “by section 412, 414, 504, 703, or 704(a)”; and (B) by striking “under section 412” and inserting “under section 412, 414(b)”; and (2) in paragraph (j), by inserting “414,” after “412,”. (d) Expedited Rulemaking.—Not later than 18 months after the date of the enactment of this Act, the Secretary shall promulgate proposed and final regulations establishing recordkeeping requirements under subsection 414(b) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)).