FDA Issues Final Rule on Food Supply Records

Early this month, the FDA 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 FDA also issued draft guidance to FDA staff and industry, which details the internal procedures the agency will follow before requesting access to records.

"Publication of this record-keeping rule represents a milestone in U.S. food safety and security," said Secretary of Health and Human Services, Tommy G. Thompson. "There is more work to do yet, but our nation is now more prepared than ever before to protect the public against threats to the food supply."

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.

"These records will be crucial for FDA to deal effectively with food-related emergencies, such as deliberate contamination of food by terrorists," said Dr. Lester M. Crawford, Acting FDA Commissioner. "The ability to trace back will enable us to get to the source of contamination. The records also enable FDA to trace forward to remove adulterated food that poses a significant health threat in the food supply."

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).