FDA delays food record-keeping and holding rules

Mar 31, 2004 (CIDRAP News) – The Food and Drug Administration (FDA) is delaying the implementation of food security rules that would require most food businesses to keep detailed records on their handling of food products and would allow the FDA to hold potentially contaminated food.

The agency previously hoped to make the rules final in March, but it was unable to meet that deadline, said Sebastian Cianci, a spokesman for the FDA's Center for Food Safety and Applied Nutrition. The new estimated completion date is sometime in May, he told CIDRAP News.

The agency received about 200 letters on the record-keeping rule and more than 100 letters on the holding, or "administrative detention," rule, he said. The letters all raised multiple issues.

The two sets of rules are designed to implement parts of the wide-ranging Bioterrorism Act of 2002 and were first proposed by the FDA in May 2003. The record-keeping rule would require food companies to keep data on the source, nature, quantity, and shipping destination of all food products handled. The aim is to allow the FDA to trace a product's history from raw materials through production and distribution in case of a contamination episode.

Though the rules are not in place, Cianci noted, "In the event of a public health emergency, the FDA currently does have the authority to access existing records or administratively detain food. That took effect when the [bioterrorism] act was signed in 2002."

FDA seeks quick response to records requests
If the FDA suspected that a food item was dangerous, the rule as originally proposed would require firms to provide requested records to the agency within 4 hours during business hours or 8 hours at other times. The proposal exempts farms, restaurants, fishing boats, and firms regulated by the US Department of Agriculture, and retail stores would not have to keep records on food buyers.

The seizure rule, as proposed, would allow the FDA to hold a food item for up to 30 days if it had evidence that the food could be harmful. An affected firm could appeal the action, and the FDA would have to decide the appeal within 5 days.

The proposed record-keeping rule has drawn objections from the food industry. For example, the Grocery Manufacturers of America told the FDA that keeping records on the movement of food items by lot or code number "is neither feasible nor necessary," according to comments posted on the group's Web site. The group also said the proposed time periods for responding to FDA requests for records are "entirely unreasonable."

According to a recent Associated Press report, Caroline Smith de Waal, head of food safety at the Center for Science in the Public Interest (CSPI), said the food industry is capable of meeting the proposed requirements, but that many firms don't want to take the time and effort. CSPI is a food industry watchdog group.

Cianci noted that the official comment period for the record-keeping and detention rules is closed, but the FDA accepts comments on its regulations at any time.

FDA to take more comments on import rules
Cianci also reported that the FDA plans to reopen the comment period for two other sets of regulations under the 2002 bioterrorism law, dealing with prior notice of food imports and registration of food facilities. Those rules officially took effect last December, but the FDA is not yet fully enforcing them.

Under the prior notice rule, food importers are supposed to give the FDA at least 2 hours of advance notice of shipments arriving by road, 4 hours' notice of air and rail shipments, and 8 hours' notice of water shipments. The rules are intended to help the FDA decide which food shipments to inspect. They cover both human and animal food.

The registration rule requires all US and foreign firms that produce, process, or hold food to be consumed in the United States to register with the FDA. The purpose, officials have said, is to provide a complete roster of food companies so the agency can quickly find affected firms in case of food contamination.

Cianci said the comment period would be reopened sometime in the next few weeks. At the same time, the FDA will publish a document detailing how its prior-notice requirements will be coordinated with some similar requirements of the Bureau of Customs and Border Patrol (CBP), he reported. "The CBP has some other timelines they're supposed to follow for giving certain information to them, so this is going to address the different time frames that exist right now," he said.

When the two rules took effect in December, the FDA said it would invite another round of comments in March (2004). The agency also said it would wait 4 months before beginning to enforce the rules.

Cianci said about 196,000 domestic and foreign food facilities have registered with the FDA so far. The agency has estimated that about 400,000 facilities are required to register.

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