FDA finalizes food detention rule

WASHINGTON, (May 31, 2004) — The U.S. Food and Drug Administration has announced the final rule under Bioterrorism Preparedness and Response Act for establishing procedures for the detention of U.S.-bound food suspected of containing “a threat of serious adverse health consequences.”

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

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. 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 is one of four key provisions of the Bioterrorism Act. Two others — the requirements that all domestic and foreign facilities that manufacture, process, pack or hold food register with the FDA, and that the agency receive a prior notification of all food imported — have already been implimented. 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.

Click on the link below to read the official rule:


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