FDA proposes food record-keeping rules under bioterrorism law

May 6, 2003 (CIDRAP News) – The Food and Drug Administration (FDA) today proposed rules that would require most food-related businesses to keep detailed records on all food products so that the government could trace a product's path through production and distribution in case of a contamination episode, the FDA announced today.

The FDA is proposing the rules under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Another proposed rule announced today sets out the FDA's procedures for detaining potentially contaminated food.

The record-keeping rule would require food companies to keep records on the source, nature, and quantity of all food products handled and on where they shipped them to, the FDA said. Farms, restaurants, fishing boats, and concerns regulated only by the US Department of Agriculture (USDA) would be exempt from the rule, and retail stores would not have to record who bought the food.

"Improving FDA's food safety inspection, detention, and monitoring capabilities is a top priority of the department," said Tommy Thompson, secretary of the Department of Health and Human Services (HHS), in announcing the rules.

The detention and record-keeping rules are the last of four sets of regulations proposed under the new law. Last January the FDA proposed rules on the registration of food facilities and on advance notice of imported food shipments.

The proposed regulations say that if a food item were believed to pose a danger to humans or animals, firms would have to provide relevant records to the FDA within 4 hours during business hours or 8 hours at other times. Companies could keep the records in any form they prefer. Records on perishable foods and food for animals would have to be kept for a year; records for all other foods would be kept for 2 years.

The FDA said it will take comments for 60 days and will issue a final rule on record-keeping 6 months from when the proposed rule is published in the Federal Register. However, small businesses (from 11 to 499 full-time workers) will have a year to comply with the rule, and very small businesses (10 or fewer workers) will have 2 years.

The detention regulation is "self-executing and already in effect," but the FDA will take comments on it for 60 days, the agency said. The regulation authorizes the FDA to hold a food item for up to 30 days if it has credible evidence that the food could cause serious harm. Affected firms can appeal a detention order, and the FDA is required to decide the appeal within 5 days.

The detention regulation does not cover meat, poultry, and egg products, which are under the USDA's exclusive jurisdiction, the FDA said.

Comments on either of the proposed rules can be sent to the FDA at Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments should include docket number 02N-0277 for the record-keeping proposal and docket number 02N-0275 for the detention proposal.

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