FDA puts food record-keeping rules in place

Dec 10, 2004 (CIDRAP News) – The Food and Drug Administration (FDA) has put the finishing touches on record-keeping rules designed to help the agency trace the sources and travels of contaminated food, but food businesses have at least a year to comply.

The new regulations, published Dec 9 in the Federal Register, require a wide range of food-handling businesses to keep records on where they receive food from and where they send it. The rules are a result of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

"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, in a Dec 6 news release. "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."

Large businesses have a year to comply with the new requirements; small and very small businesses (11 to 499 employees and 10 or fewer employees) have 18 months and 2 years, respectively.

Health and Human Services (HHS) Secretary Tommy Thompson said the rule represents a "milestone" in US food security. "There is more work to do yet, but our nation is now more prepared than ever to protect the public against threats to the food supply," he said in the news release.

The FDA announcement came 3 days after Thompson, in comments Dec 3 about his plans to leave HHS, said contamination of the food supply by terrorists was one of his two biggest worries and that he was surprised that no serious incidents had happened recently.

In a Dec 7 teleconference on HHS plans to buy influenza vaccine from abroad, Thompson qualified somewhat his earlier statements. He said the number of food-import inspectors had doubled to 1,500 since 2001 and inspections had increased from 12,000 to 98,000 per year. "But I'm still concerned because we still have only about 4 to 5% of food being inspected."

He added, "The food supply is safe. But that doesn't mean that somebody, somewhere, sometime couldn't put some kind of adulterated additives into food that could cause problems."

The record-keeping rule applies to businesses that "manufacture, process, pack, transport, distribute, receive, hold, or import" human food or animal feed, the FDA said. Firms must keep records on human food from 6 months to 2 years, depending on the shelf life of the food. Records on animal feed and pet food must be kept for a year.

Records can be kept in paper or electronic form, the FDA said. They must be available for inspection or copying within 24 hours of receipt of an FDA request. The agency has issued draft guidance on the procedures it will follow before requesting records.

The record-keeping rule is one of four food-related requirements in the 2002 bioterrorism law. The other three deal with registration of food facilities, prior notice of imported food shipments, and administrative detention of potentially contaminated food. The final regulations for those rules all were published previously.

The FDA said it would hold seven public meetings in January and February to explain the details of the record-keeping rule and answer questions. Meetings are scheduled Jan 13 in College Park, Md.; Jan 25 in Chicago and Seattle; Jan 27 in San Francisco and Orlando; and Feb 1 in Philadelphia and Boston.

See also:

Dec 6 FDA news release, with links to the final rule and draft guidance
http://www.fda.gov/Food/GuidanceRegulation/Recordkeeping/ucm061631.htm

FDA notice of public meetings
http://www.fda.gov/OHRMS/DOCKETS/98fr/02n-0277-nm00002.pdf

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