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Food Processing

Final Rule Issued on Records Needed to Protect Food Supply

The U.S. Food and Drug Administration (FDA) today issued final regulations on the establishment and maintenance of records to protect the U.S. human food and animal feed supply in the event of credible threats of serious adverse health consequences or death to humans or animals. FDA also issued draft guidance to FDA staff and industry, which details the internal procedures the agency will follow before requesting access to records.

This final regulation implements section 306 of the Bioterrorism Act, which directs the HHS Secretary to issue regulations requiring persons who manufacture, process, pack, transport, distribute, receive, hold, or import food to establish and maintain records. These records identify the immediate previous source of all food received, as well as, the immediate subsequent recipient of all food released.

The final regulation is the fourth regulation designed to increase the safety and security of the U.S. human and animal food supply under the authority of the "Public Health Security and Bioterrorism Preparedness and Response Act of 2002" (the Bioterrorism Act). The three other final regulations issued by FDA under the Bioterrorism Act that are in effect are:

  • Registration of foreign and domestic food facilities;
  • Prior notice of food shipments imported or offered for import into the U.S.; and
  • Administrative detention, so that food products that might pose a threat of serious adverse health consequences or death may be detained.

FDA will be holding four public meetings in January and February 2005 to explain the requirements of the final rule to interested parties and answer questions. Registration is on a first-come, first-served basis. Additional information on how to register for one of the public meetings or information about all four rules designed to protect the U.S. food supply is available at