Food and Drug Administration’s ability to respond to bioterrorism and other potential food-related emergencies. The Bioterrorism Act represents the largest expansion of the FDA’s regulatory authority with respect to foods in at least 50 years. For the first time in U.S. history, all manufacturers, processors, packers and holders of food under FDA jurisdiction must register with the agency and keep records with respect to the food they receive and release. In addition, those importing food into the United States must provide the FDA with prior notice of the food’s entry.
These new obligations represent an enormous change in the way food is regulated in the United States. Moreover, because Congress established very short timelines for compliance with the new requirements, the pace of that change is rapid.
The Bioterrorism Act expanded FDA authority in four key areas: 1) registration of food facilities; 2) prior notice of imported food shipments; 3) record keeping; and 4) detention of any food that credible evidence indicates presents a “threat of serious adverse health consequences or death to humans or animals.” The agency’s interim final rules on registration and prior notice took effect Dec. 12, 2003. Final rules regarding record keeping and administrative detention are expected sometime this spring.
Throughout the rulemaking process, the FDA has demonstrated a willingness to listen and respond to industry concerns. The agency has also demonstrated a commitment to enforcement discretion. In written guidance to its field operations staff, the FDA stated that its intention in the coming months is to inform and educate industry with respect to the new requirements, not to pursue punitive enforcement actions.
In general, detention has not been controversial. The Act gives the FDA authority to detain food for up to 30 days if the agency has credible evidence indicating that the food presents a threat.
Record keeping has sparked greater concern. The agency’s proposed rule, published May 9, 2003, would require all facilities that manufacture, process, pack, hold, transport, distribute, receive or import food (including foreign facilities, if required to register with FDA) to keep records with regard to all food they release and receive. Farms, restaurants, and facilities that handle food under the exclusive jurisdiction of the U.S. Department of Agriculture’s Food Safety and Inspection Service would be exempt. The FDA’s proposal does not specify the form in which records would have to be kept, and the agency makes clear that companies could use existing commercial records to satisfy the record-keeping obligation. However, the records would have to contain certain information, as detailed in the proposal.
Concerns about the proposed record keeping requirements center around the apparent need to track lot and code numbers to the individual retail store level—a practice that is not in place today and could not be implemented without incurring enormous costs. The final rule, expected soon, should reveal the agency’s position on lot/code number tracking to the store level.
The FDA’s new Bioterrorism Act requirements are detailed and complex. Fortunately, a great deal of explanatory information is available—from the FDA itself, trade associations and consultants. If you believe your business is affected by the new rules, use these sources to familiarize yourself with the general requirements.
If you missed the Dec. 12, 2003, deadline for registration, take advantage of the FDA’s widely announced period of enforcement discretion and register the facilities online at www.fda.gov. If you import finished foods and/or food ingredients, make sure everyone in your supply chain is registered, if required. Failure to register could lead to delays at the U.S. border. Finally, be aware that your customers may demand—if they have not already done so—proof of your business’ compliance with the new requirements. Ask yourself whether and how your business can demonstrate that compliance, and be ready to respond when asked.
Andrea Bruce, [email protected], is a partner in the Washington, D.C., office of the law firm Hogan & Hartson LLP. She focuses her practice on U.S. food regulatory issues.
