FDA sets new rules to avert bioterror

FDA sets new rules to avert bioterror

Starting Dec. 12, food importers must give advance online notification to the Food and Drug Administration of shipments entering U.S. borders. FDA also will require registration of all domestic and foreign food facilities to tighten security around the nation's food supply.


The new regulations let the agency quickly identify the processors in case of deliberate or accidental food contamination, Health and Human Services secretary Tommy Thompson said yesterday. FDA is an agency of HHS, which published the rules in today's Federal Register.

'We are providing critical new tools for FDA to identify potentially dangerous foods and better keep our food supply safe and secure,' Thompson said. They cover all facilities that process, pack or hold food for human or animal consumption.

The regulations activate key provisions of the 2002 Public Health Security and Bioterrorism Preparedness and Response Act, which gave FDA new authority to protect the nation's food supply against actual or threatened terrorist acts and other food-related emergencies.

Food importers must notify FDA of shipments two to eight hours before their shipments arrive, depending on truck, rail or air arrival, and must receive electronic confirmation before unloading. The notification times could be reduced in the future as FDA and the Customs and Border Protection Bureau better coordinate their border management activities.

The advance notification to FDA must be submitted through Customs' existing Automated Broker Interface/Automated Commercial System. FDA will operate a new Prior Notice System Interface to receive the notifications. It expects to receive about 25,000 notices of incoming shipments each day.

'Using the electronic data under these regulations and a sophisticated automated targeting system, CBP and FDA will be working side by side to make joint decisions about food shipments that could pose a potential threat to the United States,' Customs and Border Protection commissioner Robert Bonner said.

Food facilities can register with FDA via the Internet, surface mail or fax beginning Oct. 16. The agency expects about 420,000 registrations.

About the Author

Mary Mosquera is a reporter for Federal Computer Week.

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