Second half of FDA bioterror rules to be finalized in May
The U.S. Food and Drug Administration plans to publish in May final rules implementing recordkeeping and administrative detention regulations under the 2002 Bioterrorism Prevention Act, spokesman Sebastian Cianci said.
The rules originally were supposed to be completed in March.
The law requires manufacturers, processors, distributors, importers and others involved in the food chain to maintain records on the source of food received and the subsequent recipient of outbound food shipments so the government can trace the food back to its origin in the event of a food emergency, such as a disease outbreak or terrorism-related contamination. The FDA can request records from a company, but until regulations are issued spelling out exactly what types of records must be kept, a company could not be held accountable if it doesn't have a particular document.
Similarly, the FDA has authority under the law to hold food in place if a danger is suspected. The new regulations will support exactly how the FDA will carry out administrative detentions.
FDA is phasing in compliance of the requirement that all food foreign and domestic food facilities that manufacture, process, pack or hold food for U.S. consumption register with the agency. Since the rule went into effect in December, 198,000 warehouses and other facilities have registered, including 102,000 overseas locations, Cianci said. That figure is less than half of the 420,000 facilities the agency estimated are covered by the rule.
The rate of registration dropped off in December after the FDA announced that enforcement would be implemented gradually, and officials are hoping registrations will start to increase. Officials suspect that many companies do not realize the law applies to them, Cianci said.