December 7, 2004

FDA Issues Final Rule on the Establishment and Maintenance of Records to Enhance the Security of the U.S. Food Supply Under the Bioterrorism Act

This week, FDA announced publication in the Federal Register on December 9, 2004, of 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. The final rule is available on FDA's website.

This final rule implements section 306 on recordkeeping 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.

This 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 Bioterrorism Act. FDA has already issued three other final regulations under the Bioterrorism Act, which are in effect. They cover:

• Registration 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FDA also issued draft guidance to FDA staff and industry, which details the internal procedures the agency will follow before requesting access to records. The guidance is available on FDA's website.

FDA will hold seven public meetings in January and February 2005 to explain the requirements of the final rule to interested parties and answer questions.

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 on the FDA website.