May 27, 2004 (CIDRAP News) The Food and Drug Administration (FDA) today issued a final rule spelling out its procedures for detaining food suspected of being hazardous because of intentional or accidental contamination.
The Bioterrorism Act of 2002 authorized the FDA to detain food for up to 30 days if the agency has evidence that it poses a serious threat to humans or animals. That authority began when the act was passed, but the agency's procedures for using the power were not established until now.
In the past, the FDA generally relied on the states to detain hazardous food temporarily until the FDA could get court authority to deal with it, FDA officials said in a telephone news conference today. The bioterrorism law gives the agency authority to act immediately on its own, officials said.
"This rule describes how FDA can hold food in place while it initiates legal action in court to seize it and permanently remove it from commerce," Acting FDA Commissioner Dr. Lester M. Crawford stated in a news release. "Alternately, our experts can determine that the food is safe, and the detention order may be terminated."
The rule applies to all foods under FDA jurisdiction and to nonfood items that touch food, said Leslye M. Fraser, associate director for regulations at the FDA's Center for Food Safety and Applied Nutrition. (The FDA does not regulate meat, poultry, and eggs, which are under the US Department of Agriculture's jurisdiction.)
The owner or agent in charge of the food can appeal a detention order and request an informal hearing, the FDA said. The agency then must hold a hearing within 2 days and issue a written report of the hearing. Participants in the hearing will have 4 hours to review the report and comment on it, Fraser said. The FDA must issue a decision within 5 days after the hearing.
In response to a question, Fraser said the FDA does not have authority to reimburse the owner if the food goes bad while it is being detained. "We have to have credible evidence or information that we have a serious health threat here, so we want to make sure we err on the side of consumer safety while we hold the food to investigate whether there is a health threat," she said. The bioterrorism law doesn't provide for reimbursement, she added.
The FDA first proposed its "administrative detention" rule a year ago, and it generated more than 100 comments from the public, according to Crawford. Fraser said the agency made minor changes in the rule in response to the comments. One change was to add the requirement that the FDA hearing officer issue a written report of any appeal hearing, she said.
The standard for detaining a food item is "credible evidence" that it poses a threat of "serious adverse health consequences." Crawford said the agency will soon announce how it defines "serous adverse health consequences."
The administrative detention rule is one of four major pieces of the 2002 bioterrorism law that pertain to the FDA. Last October the agency published final rules requiring food firms and facilities to register with the government and to provide advance notice of shipments of imported food. The FDA said it will soon issue a fourth rule, dealing with record-keeping requirements designed to help the FDA track contaminated food.
See also:
May 27 FDA news release
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2004/ucm108305.htm
