FDA final ruling on Bioterrorism Act

The Food and Drug Administration today announced the final rule establishing procedures for administrative detention of food under the authority of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). This new authority applies to food for which the agency has credible evidence or information that it presents a threat of serious adverse health consequences or death to humans or animals.

"These regulations lend an additional layer of protection to our defenses against bioterrorism," said Secretary of Health and Human Services Tommy G. Thompson. "The rule strengthens the security of our food supply by enabling us to act more quickly and effectively to prevent potentially contaminated food from reaching consumers."

The Bioterrorism Act authorized the FDA to administratively detain suspect food as soon as it was enacted. The final regulation, which goes on display today at the Office of the Federal Register, clarifies the agency's administrative detention procedures and the process for appealing the detention order.

"Identifying and removing contaminated food from the food supply is an essential part of responding to terrorist acts," said Dr. Lester M. Crawford, Acting FDA Commissioner. "This rule describes how the FDA can hold food in place while it initiates legal action in court to seize it and permanently remove it from commerce. Alternately, our experts can determine that the food is safe, and the detention order may be terminated. Either way, consumers are protected."

Under the final rule, FDA may detain an article of food on the strength of credible evidence or information resulting from an inspection, examination, or investigation. The rule requires a detention order to be approved by the FDA District Director of the district where the detained article of food is located, or by a higher official. A copy of the detention order would be given to the owner, operator, and/or agent in charge of the place where the article of food is located, and to the owner of the food provided the owner's identity can be determined readily. If FDA issues a detention order for an article of food located in a vehicle or other carrier, the agency also must provide a copy of the detention order to the shipper of record and the owner and operator of the vehicle or other carrier provided the owner's identity can be determined readily.

The final rule requires detained articles of food to be held in secure locations, as determined by FDA. The food may not be transferred from the place where it has been ordered detained, or from the place where the detained article has been removed without FDA approval, until FDA terminates the detention order, or the detention period expires. A detention may not exceed 30 days, and violation of a detention order is a prohibited act.

The new rule implements one of four key provisions of the Bioterrorism Act that are primarily designed to ensure the safety and security of food. Two other important regulations implementing the Act were issued by the FDA on October 10, 2003. These two interim final rules require that all domestic and foreign facilities that manufacture, process, pack or hold food that will be consumed in the U.S. to register with the FDA, and that the agency receive a prior notification of all food imported or offered for import into the U.S. regardless of whether it will be consumed in the U.S. FDA plans to issue shortly the fourth final rule, which will cover the establishment and maintenance of records to allow for the identification of the immediate previous sources and immediate subsequent recipients of food to help FDA track food implicated in future emergencies.

These rules are part of the FDA's continuing effort to ensure the safety and security of the nation's food supply. While the administrative detention authority applies to both domestic and imported food, FDA envisions using it primarily for food already in domestic commerce, since the agency and CBP have other authorities that also apply to imported food.