Administrative Detentention Rule Issued

 

Bioterrorism Act:
Final Administrative Detention Rule Differs Slightly From Proposal

The final rule establishing procedures for administrative detention of food under the authority of the Bioterrorism Act has been issued by FDA and will be published in the June 4 Federal Register -- FDA Release, FDA Fact Sheet. FDA plans to issue the fourth final rule on recordkeeping shortly. The 2002 Bioterrorism Act authorized the FDA to “administratively detain” suspect food but this final regulation details the procedures. Among the changes from the proposed rule summarized for The Food Institute by Olsson, Frank & Weeda, P.C.:

• If a detention order is appealed, FDA must hold a hearing within two calendar days after the appeal is filed for both perishable and non-perishable foods. Under the proposed rule, FDA would have had three calendar days in the case of non-perishable foods.

 

 

 

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• The final rule requires the presiding officer at the hearing to issue a written report of the hearing, and gives the participants four hours to comment on the report before the officer issues a decision. This was not in the proposed rule.

• FDA has changed the term “limited conditional release” used in the proposed rule to avoid confusion with Customs terminology.

NOTE: The final rule authorizes FDA to detain any food under FDA jurisdiction. The definition of “food” for purposes of detention includes food contact substances. This differs from the registration and prior notice rules.

The National Food Processors Association called the rule a "powerful tool for protecting the public" but urged that it be used sparingly. "We believe that the request for a voluntary recall still represents the most viable option for a majority of these situations, with detention being considered as a second option," the association said in a statement

Leslye Fraser, of the FDA's Center for Food Safety and Applied Nutrition, said the rule applies to all food, perishable or not, animal feed and supplements – “anything you would think of as food or anything that would touch food.” She said the rule could apply to imports, but other rules allow FDA to seize imported food so it would more likely be used for domestic commerce. “We have to have credible evidence or information that we have a serious health threat here,” Fraser said. If the food goes bad during the 30 days it is being held, there is no mechanism for compensating the owners, she told said.

Source: The Food Institute, 1 Broadway, Elmwood Park, NJ 07407, phone (201)791-5570, Fax: (201)791-5222