FDA Issues Revised Regulations on Food Imports To Help Protect Safety of U.S. Food Supply
The FDA on Thursday issued two regulations intended to protect the nation's food supply from terrorist attack by requiring all food importers to give the agency prior notice of shipments and all food manufacturers and distributors to register with the agency, the Washington Post reports (Kaufman, Washington Post, 10/10). The regulations, which were mandated by the Bioterrorism Act of 2002, were first proposed earlier this year, but they drew heavy criticism from food manufacturers and importers, who said that they would raise costs and slow trade without significantly improving safety (California Healthline, 1/30). However, the regulations have been revised since the FDA met with food industry leaders to discuss their concerns, and "food producers and distributors embraced the new rules yesterday," the Post reports (Washington Post, 10/10).
Under the former proposal, food importers would have had to inform the FDA at least one day before a food shipment arrived in the United States, explain the contents of the shipment and estimate the time of arrival. The FDA could have held food products at the port of entry in the event that importers did not comply with the requirements, and importers would have had to pay the agency for required storage or transportation costs (California Healthline, 1/30). Under the new regulations to be implemented Dec. 12, importers who ship nearly any type of food -- excluding those regulated by the U.S. Department of Agriculture, such as meat, poultry and eggs -- must notify the FDA two hours before shipments arrive by truck, four hours before arrival by air and eight hours before arrival by boat. In response to industry concerns about excessive additional paperwork, the FDA said that it will coordinate reporting efforts with the U.S. Customs Service to let companies electronically submit more than 80% of their notices to both agencies (Foley/Wilde Mathews, Wall Street Journal, 10/10). The reporting system will analyze more than 100 risk factors, including the type of food being shipped, its country of origin and the histories of the importer and food producers involved, to determine whether shipments should be inspected (Washington Post, 10/10). The FDA expects to receive about 25,000 shipment notifications each day (HHS release, 10/9).
The second regulation will create a registry of about 400,000 food manufacturers and distributors and their products, which is expected to cost the industry $336 million during its first year (Gersema, AP/Las Vegas Sun, 10/9). The registry is intended to facilitate the process of identifying and locating affected food processors and other establishments if food is contaminated. The FDA will begin accepting electronic registrations on Oct. 16 (HHS release, 10/9). The agency is accepting comments on the regulations for 75 days, but FDA officials do not expect any major changes when the final rules take effect. The regulations will be implemented using "enforcement discretion" for four months to allow flexibility for companies as they try to meet compliance (Wall Street Journal, 10/10). Two final food supply regulations will be issued later this year that will require paperwork tracing where food is grown and processed and will give the FDA "clear authority" to halt shipments at U.S. borders, according to FDA Commissioner Dr. Mark McClellan, the Post reports (Washington Post, 10/10).
HHS Secretary Tommy Thompson said, "By requiring advance notice for imported food shipments and registering domestic and foreign food facilities, we are providing critical new tools for the FDA to identify potentially dangerous foods and better keep our food supply safe and secure," adding that FDA officials "listened carefully" to the food industry's concerns to develop "workable and feasible" rules that will make "the food supply safer and more secure without hindering trade" (HHS release, 10/9). John Cady, president and CEO of the National Food Processors Association, said, "The changes not only maintain the effectiveness of these new regulations but also increase their workability." However, officials for the Center for Science in the Public Interest criticized the FDA for weakening advance notice requirements that might facilitate avoiding inspections in the face of "food industry pressure" (Washington Post, 10/10).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.