FDA finalizes bioterrorism food safety rules


ROCKVILLE, MD. - Termed by Health and Human Services (HHS) Secretary Tommy Thompson as “a milestone in U.S. food safety and security,” the Food and Drug Administration (FDA; is now requiring that food producers and distributors establish and maintain records to further protect the human and animal food supply.

The fourth and final FDA rule under section 306 of the Bioterrorism Act 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 that identify the immediate previous source and subsequent recipient of its food products.

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

The required record retention for human foods ranges from six months to two years depending on shelf life, while animal food records-including pet food-must be retained for one year. For transporters, the maximum record retention requirement is one year.

Companies may keep their records in paper or electronic format. Except for the smallest businesses, compliance must occur within one year from the date the rule is published in the Federal Register. Small businesses (11 to 499 full-time employees) must comply within eighteen months, and very small businesses (10 or fewer full-time employees) must comply within two years.

The three other FDA regulations under the Bioterrorism Act already in effect are registration of foreign and domestic food facilities; prior notice of food shipments imported or offered for import in the U.S.; and administrative detention-allowing the right to detain food products that might pose a threat of serious health consequences.