The standards were mandated by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which was passed in response to concerns about terrorist attacks on the nation’s food supply.
Industry representatives met with officials from the Office of Management and Budget (OMB), which reviews and must approve all major rules, on numerous occasions in what appears to have been a successful effort to weaken the prior notice requirements. The original proposal, issued in February for public comment, required importers to notify the FDA by noon the day before a shipment was to arrive. The final standards, however, require just eight hours notice for shipments arriving by sea, four hours for those transported by air or rail, and only two hours for shipments coming by land.
“These regulations are critically needed to protect the food supply, but we’re concerned that the agency is requiring less advance notice for imported food shipments,”
said Caroline Smith DeWaal of the Center for Science in the Public Interest. “If trucks of food can arrive at our borders with just two hours notice, it might be easier for someone to avoid inspection.”
FDA also issued standards requiring facilities that manufacture, process, pack or store food to register with the agency. Both rules take effect December 12.