Food and beverage companies face a December 12 compliance date with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Importers of raw materials and finished goods are seen as bearing the brunt of the implementation regulations, but all processors are affected by the registration and product tracking requirements.

While the FDA estimates 200,000 U.S. food facilities and an equal number of foreign plants will be registered in a central database, “that number may be understated by a factor of 10,” predicts Clay Detlefsen, counsel and regulatory affairs vice president of the International Dairy Foods Association. Not only processors by transport companies, packaging material suppliers, equipment manufacturers of food-contact surfaces and others would be required to register, and that could create a database too large and unwieldy to be useful, he says.

More problematic is the level of detail being discussed for product tracking, including lot or code numbers for all ingredients and packaging supplies. “Some companies have told me they think they can handle the backward and forward tracing being required,” Detlefsen says, but small and mid-sized firms may have to scrap existing systems to comply with the forward-tracing requirements. IDFA advocates using the existing Class I recall system to quickly and efficiently remove any suspect food products, rather than impose detailed record-keeping requirements.

Under the Act, companies must be able to implement a recall within four hours, or eight hours on weekends.