Unprecedented Agreement Between the Agencies Advances FDA's Implementation of the Bioterrorism Act.
The Food and Drug Administration (FDA) and the U.S. Customs and Border Protection (CBP) today signed a memorandum of understanding (MOU) that allows FDA to commission thousands of CBP officers in ports and other locations to conduct, on FDA's behalf, investigations and examinations of imported foods. This unprecedented FDA-CBP collaboration significantly strengthens the implementation of the Bioterrorism Act to assure the security of imported foods.
The MOU was signed by FDA Commissioner Mark B. McClellan, M.D., Ph.D., and CBP Deputy Commissioner Douglas Browning at U.S. Customs and Border Protection headquarters in Washington, D.C.
"This MOU is an important milestone in our extensive efforts to protect the safety and security of the national food supply," said Commissioner McClellan. "It enables us to work more efficiently with CBP, combining their strong resources with our own expertise in keeping on the alert for potentially hazardous foods and responding to possible threats. We are committed to using the Bioterrorism law to safeguard our food supply to the fullest extent possible, without imposing any unnecessary costs or restrictions on food imports."
"We are pleased to be an integral part of this new initiative to safeguard the country's food products," said Deputy Commissioner Browning. "This agreement reflects close cooperation and countless hours of discussion not only with FDA, but with our trade partners here and around the world. It also supports our twin goals of securing the border from terrorists and terrorist weapons while ensuring the movement of legitimate trade."
Building on FDA's and CBP's long history of close cooperation, the MOU upgrades the two agencies' teamwork in training, day-to-day operations, and information sharing. As part of the MOU, FDA can commission all the CBP officers the two agencies consider necessary to conduct examinations and investigations in accordance with the FDA's recently issued interim final rule requiring prior notice of food imported or offered for import to the United States. FDA and CBP will provide specialized training for the commissioned CBP employees who will carry out this work, and both agencies will expand their existing cooperative arrangements to directly share information affecting the safety and security of imported foods. The MOU goes into effect immediately.
FDA is already in the seventh week of implementing another of the four enabling regulations under the Bioterrorism Act, which requires registration of food facilities that manufacture, process, pack or hold food or feed for the U.S. market. To facilitate this massive undertaking, which involves more than 400,000 domestic and foreign firms, FDA created a new Internet system where these companies can log onto any time of the day or night, seven days a week, and register in just a few minutes. Both the prior notice and registration requirements were proposed by FDA on January 29 of this year, submitted for stakeholders' comments, and published as interim final rules on October 10. By using CBP's advanced ABI/ACS electronic communication systems and working with other agencies, FDA was able to reduce the length of the prior notice from at least 12 hours to 2-8 hours, depending on the mode of transportation.
FDA and CBP have conducted extensive domestic and foreign outreach jointly and independently, to explain the proposed rules to consumers and the food industry. In addition to holding three large public meetings via satellite downlink, FDA and CBP officials answered questions about the rules by attending six public meetings from coast to coast, delivered numerous presentations for trade groups and industry associations, and discussed the proposals with government and industry officials in Canada, Mexico, the European Union, and the Caribbean. By now, close to 100,000 firms -- most of them foreign -- have registered with FDA.
Finally, FDA announced today that it plans to finalize, by the end of March 2004, the last two critical rules under the Bioterrorism Act, both of which were proposed in May of this year. The proposals deal with the establishment and maintenance of records related to food, and administrative detention for food shipments that could harm the health of humans or animals. Both proposals received numerous substantive comments from concerned stakeholders that the agency needs to finish analyzing and consider before issuing the final regulations. While these two regulations are being completed, FDA can use authorities granted by the Bioterrorism Act to detain foods and obtain records in advance of issuing final rules.
"We want all FDA bioterrorism regulations to be examples of a government that communicates with stakeholders in order to craft clearly understood rules that protect consumers without creating undue burden on the industry," said Commissioner McClellan. "In the meantime, we have taken steps to make sure that food that presents a threat will be detained and all available records will be used to track down significant food risks."
The rulemaking for the provision dealing with the administrative detention of foods or animal feed that may pose a serious public health hazard has no mandated deadline. FDA emphasizes that section 303 of the Bioterrorism Act, which is in effect now, allows FDA to order the administrative detention of any food or feed if there is credible evidence or information indicating the article presents a threat of serious adverse health consequences or death to humans or animals.
Congress has directed that the other proposed rule, which requires domestic food firms and foreign transporters to establish and maintain records of food shipments, should be completed by December 12. While addressing the comments on this proposed rule, FDA underscores its readiness to make use, if necessary, of authorities in sections 414(a) and 704(a) of the Food, Drug and Cosmetic Act, as amended by the Bioterrorism Act, which are currently in effect. These provisions give the agency access to firms' existing records that identify the immediate previous sources and immediate subsequent recipients of food and feed, if FDA believes the products are adulterated and present a serious or deadly health hazard to humans or animals.