New FDA rules require advance approval for food imports
By Staff -- Logistics Management, 1/1/2004
The federal security juggernaut continues to roll on. On December 12, all domestic and foreign facilities that manufacture, process, pack, or store food, drink, and dietary supplements for human or animal consumption in the United States were required to comply with new security rules issued under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act).
Those rules mandate that all such facilities register with the Food and Drug Administration (FDA). Retail establishments that primarily sell directly to consumers, such as grocery stores and restaurants, are exempt. Warehouses and distribution centers that serve them, though, must register.
Foreign facilities that supply food products to the United States also must designate an agent to communicate with the FDA on their behalf. Additionally, the FDA must receive an electronic notice of any food import and approve its release at least 2 to 8 hours prior to its arrival in the United States, depending on the mode of transportation.
The FDA will train thousands of Bureau of Customs and Border Protection (CBP) officers to examine imports for compliance with the new rules, more than tripling the FDA's inspection and enforcement resources on the borders. Both agencies will phase in enforcement until August 12, 2004, when non-compliant shipments will be refused entry.
The prior notice requirement is a little tricky, says Jack Rafferty, managing director, trade and regulatory services, for forwarder PBB Global Logistics in Fort Erie, Ont. Notices can be electronically submitted to CBP via the Automated Commercial System, which will automatically forward them to the FDA. But the data required by both agencies is not identical.
The Food and Drug Administration, moreover, requires separate notices for each FDA-specified product code. Those codes can differ depending on packaging and other factors. Six-ounce and 12-ounce cans of tuna, for example, would require separate notifications, he notes.
Food industry groups say they've been educating their members about the upcoming changes in the rules for months and don't anticipate major problems with facility registration, although they still question some aspects of that requirement.
"I believe our industry will be well ahead of the game," says Michael Mason, public affairs director for the National Grocers Association, which represents independent food retailers and wholesalers.
At press time, the FDA had received nearly 100,000 online registrations—an impressive number, but still far below the 400,000 facilities the agency estimates must comply with the law.
Those same groups are even more worried about the prior notice requirement. The FDA expects to receive as many as 20,000 electronic notices a day, says David French, senior vice president of government relations for the International Food Service Distributors Association. He worries that the agency's information systems may not be able to handle that volume, creating backlogs and potentially leading to costly losses of time-sensitive perishables. "These rules threaten to swamp the FDA with a volume of information the FDA will find very difficult to process in a timely fashion," he says.
There were indeed some "glitches" with the FDA's electronic approvals system in the first days, Rafferty says, but he expects them to be resolved quickly. Still, he recommends that any company that buys, sells, or distributes imported foods prepare for possible delays. That may include building extra time into order processing and shipment scheduling, as well as reconfiguring packaging and documentation to minimize the number of prior notices that would be required for each shipment.
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