To: Seafood Community
The third of four new food bioterrorism regulations under the Bioterrorism
Act of 2002 was announced today: Administrative Detention. Here's a
summary from the FDA web site that describes this new rule:
"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."
Source: http://www.fda.gov/bbs/topics/news/2004/NEW01073.html
A fact sheet is on the web and provides answers to several questions about
this new regulation: http://www.cfsan.fda.gov/~dms/fsbtac21.html
The rule is posted as a .pdf file and is 250 pages:
http://www.fda.gov/OHRMS/DOCKETS/98fr/02n-0275-nfr0001.pdf
Regards,
Pamela Tom
University of California
Sea Grant Extension Program
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