Page:United States Statutes at Large Volume 116 Part 1.djvu/695

 PUBLIC LAW 107-188—JUNE 12, 2002 116 STAT. 669 such registrations, the Secretary shall ensure adequate authentication protocols are used to enable identification of the registrant and validation of the data as appropriate. (e) RULEMAKING; EFFECTIVE DATE. —Not later than 18 months Deadline. after the date of the enactment of this Act, the Secretary of Health and Human Services shall promulgate proposed and final regulations for the requirement of registration under section 415 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a) of this section). Such requirement of registration takes effect— (1) upon the effective date of such final regulations; or (2) upon the expiration of such 18-month period if the final regulations have not been made effective as of the expiration of such period, subject to compliance with the final regulations when the final regulations are made effective. 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. 21 USC 350c. "(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 Applicability, 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.

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