Final food security rule issued by FDA under Bioterrorism Act

Published 8 December 2005

New rule covers record-keeping related to human and animal food

The FDA yesterday released the fourth and final rule to protect the security of human and animal food supply falling under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The rule, which implements section 306 of the act, addresses establishment and maintenance of record-keeping by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food.

Under the new rule, any organization that handles food must keep records about the immediate source and immediate destination of that food, keeping such records on file for a period determined by the shelf life of the product and whether it is destined for humans or animals. Records can be electronic or paper-based and must be kept easily accessible, and record-holders will be liable to civil and criminal penalties for non-compliance. The FDA also issued draft guidance on how it will access such records in case of a suspected food safety incident.

The FDA has issued three other regulations under the Bioterrorism Act, concerning registration of foreign and domestic food facilities, prior notice of food shipments imported or offered for import into the United States, and administrative detention, so that food products that might pose a threat of serious adverse health consequences or death may be detained. The agency plans to hold a series of seven public meetings in January and February of next year to explain requirements of the new rule to interested parties and answer questions.

-read the FDA press release