记录的维护和检查(Federal Food, Drug, and Cosmetic Act Sec. 350c - Maintenance and inspection of records)

　　Sec. 414. [21 USC §350c] 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.

　　（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 USC 601 et seq.）, the Poultry Products Inspection Act （21 USC 451 et seq.）, or the Egg Products Inspection Act （21 USC 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）.

更多有关《联邦食品、药品和化妆品法》的内容，请点击《联邦食品、药品和化妆品法》第II章及第IV章食品法规汇总。