Food imports require electronic notice

FDA fact page on the new regulations

Beginning Dec. 12, companies importing food into the United States will have to electronically notify the Food and Drug Administration beforehand.

The new regulations announced today also require food manufacturers and handlers to register with the FDA. The rules, which implement several key provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, are intended to make it easier for agency and U.S. Bureau of Customs and Border Protection (CPB) officials to ensure food safety, officials said.

For notification, the FDA will be using its Prior Notification System Interface and the Automated Broker Interface (ABI) of the Automated Commercial System (ACS), run by the customs agency. This should make it easier for importers to comply with the new regulation since many are already using ACS, officials said.

The FDA expects to receive about 25,000 notifications on incoming shipments each day and estimates that more than 80 percent of the notices will go through the customs system.

"Using the electronic data required under these regulations and a sophisticated automated targeting system, CPB and the FDA will be working side-by-side to make joint decisions about food shipments that could pose a potential threat to the United States," CPB Commissioner Robert C. Bonner said at the announcement.

The registration requirement will allow the FDA to quickly identify and work with food companies affected by food contamination. The agency expects about 420,000 facilities to register under the new requirement. Electronic registration will open Oct. 16.

Registration may be done by mail or fax, but the FDA prefers registrations through the Internet or CD-ROM because of improved efficiency and cost savings for the agency and the user. In particular, the Internet system will not accept a registration until all necessary information is provided, thereby eliminating bad registrations.

FDA officials plan to hold several national and international meetings about the new rules. On Oct. 28, one meeting will be available by satellite downlink. Information about that meeting is available at www.fda.gov/OHRMS/DOCKETS/98fr/03-24921.htm.