In all likelihood, the Bioterrorism Preparedness and Response Act of 2002, which was passed last June, is under your radar. But it can't stay that way if your operation is one of some 400,000 domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. All of those processing and warehousing facilities must be registered with the FDA by December 12, 2003.

Under regulations proposed by the FDA, facility owners would provide basic information about the location of their facilities, the parent company, emergency contact information, and detailed information about the product categories handled in the facility. The FDA, in turn, will issue each facility a unique registration number. What's happened since June? According to the FDA, the first step toward registration took place in January 2003, when the FDA published proposed regulations to implement the provisions of the act, including a sample registration form.

That was followed by a 60-day public comment period. Final regulations will be published on October 12. By then, an electronic registration system should be operational. Food facility owners will then have 60 days to register.

But whether or not the electronic registry is up and running, all food facilities doing business in the US must register by the Dec. 12, deadline, even if the FDA has not issued final regulations. Failure to register can result in a civil or criminal action in federal court, and detention at the port of entry of any food from unregistered foreign facilities. For more information, visit http://www.fda.gov/oc/bioterrorism/bioact.html.