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By Tom Karst (Dec. 15) Providing an eight-month learning curve, the U.S. Food and Drug Administration on Dec. 11 issued a compliance policy guide that promises lots of education before import shipments are refused because of violations of bioterrorism act regulations. The document details the federal strategy for maintaining commerce while enforcing rules associated with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. A news release from the FDA said the guide addresses details related to the enforcement of the prior notice of food shipments provision of the law, which was to take effect Dec. 12. The FDA said the phase-in period would end Aug. 12. OPTIMISTIC RECEPTION Lee Frankel, president of the Fresh Produce Association of the Americas, Nogales, Ariz., said he was pleased with the spirit of the policy. However, he said it’s important that shippers not be penalized too severely for repeated violation as they try to adjust to the rules. “The policy guide still allows room for serious problems, but if they follow the spirit of this, it looks fairly reasonable,” Frankel said. The prior-notice rule states that the FDA must receive a prior notification of all human and animal food, drinks and dietary supplements imported or offered for import to the U.S. Another regulation from the bioterrorism act requires all facilities that manufacture, process, pack or hold food for consumption in the U.S. be registered with FDA. The FDA said the registration requirement for foreign facilities will be enforced primarily through the prior-notice provision. In October, the FDA and Customs and Border Patrol jointly published an interim final rule that specified that, among other requirements, prior notice must be received by the FDA between two and eight hours — depending on the mode of transportation — before each shipment’s arrival at the border. GOOD-FAITH EFFORT As the rule takes effect, the FDA and CBP expect a good-faith effort at compliance, the news release said. The policy guide issued Dec. 11 makes clear that during the next eight months, the two agencies plan to educate the affected firms and individuals. During this period, the agencies will use communication and education initiatives, escalating imposition of civil monetary penalties, and ultimately refusal of shipments. The FDA and CBP generally will continue their education efforts and will not refuse admission of product before Aug. 12 because of inadequate prior-notice compliance, the release said. “Our intention all along has been to implement the Bioterrorism Act in a way that would protect consumers without obstructing the food imports, on which we depend for 20% of all fresh produce and up to 60% of all the seafood consumed in the U.S.,” said FDA Commissioner Mark McClellan in the release. The FDA said the agencies were embarking on an extensive educational campaign that will include seminars and written materials to help the food chain comply with the regulations.
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