Just about everybody involved in the food industry is about to feel the fallout from the 2001 terrorist attacks. New government rules designed to enhance the security of the U.S. food supply take effect this month.
The two rules, which were issued in October by the Food and Drug Administration (FDA), were mandated by the Bioterrorism Act of 2002. The first requires all domestic and foreign facilities that manufacture, process, hold or pack food intended for consumption by humans or animals in the United States to register with the agency. The second requires importers to provide the FDA with advance electronic notice of any food imports.
Though the new rules are less stringent than the version first proposed last February, David French, senior vice president of government relations for the International Food Distributors Association (IFDA), warns food importers to expect some glitches—and some delays—when the import notice rule takes effect. "When an importer has to file notice, a lot of things could go wrong," he says. "If I were running a company importing product, I'd be anxious."
While complying with the import notification rule's various provisions could prove complicated, compliance with the registration rule, which covers tens of thousands of businesses, should be a relatively straightforward matter. Facilities covered by the registration rule can register online at www.access.fda.gov; by mailing or faxing the completed form to the FDA; or by sending a CD-ROM with the required information to the FDA. The FDA expects as many as 400,000 facilities to apply for a registration number, which will be required to do business in the United States. French says that while he understands that the registration process has proceeded relatively smoothly so far, a few companies have experienced problems— largely as a result of corporate firewalls preventing online registration.
Companies that clear the registration and import notification hurdles will soon face another regulatory challenge, however. The FDA has yet to issue a third rule outlining the record-keeping requirements for all parties involved in the food industry. Food businesses are worried that the rule, which is expected to be issued this month, will require them to keep track of lot numbers, according to French. "Lot numbers are really the domain of manufacturing, and nobody keeps lot numbers after products leave the manufacturer's door," he explains. IFDA and other groups have asked the FDA to consider using purchase order numbers instead.