FDA's Final Rule on Administrative Detention of Food Under the Bioterrorism Act
The Food and Drug Administration (FDA) has issued a final rule, effective July 6, 2004, which amends 21 CFR Parts 1, 10, and 16 to provide procedures for the administrative detention of an article of food, if an officer or qualified employee of the FDA has credible evidence or information indicating that such article presents a threat of serious adverse health consequences or death to humans or animals.
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This is Part III of a multi-part series of summaries of this final rule. Part III highlights those what the FDA has identified as "key' features of the final rule. (See future issues of ITT for additional summaries).
Highlights of Key Features of the Final Rule on Administrative Detention
In the preamble, FDA states that the following are key features of the final rule on administrative detention of food (partial list):
An officer or qualified employee of the FDA may order the detention of food for up to 30 calendar days if FDA has credible evidence or information that the food presents a threat of serious adverse health consequences or death to humans or animals.
FDA's District Director in the district in which the article of food is located, or an FDA official senior to such director, must approve a detention order.
FDA may require that the detained article of food be labeled or marked as detained with official FDA tags or labels. FDA's tag or label will include, among other information, a statement that the article of food must not be consumed, moved, altered, or tampered with in any manner for the period shown, without the written permission of an authorized FDA representative.
A violation of a detention order or the removal or alteration of the tag or label is a prohibited act.
FDA will state in the detention order the location and any applicable conditions under which the food is to be held.
If FDA determines that removal to a secure facility is appropriate, the article of food must be removed to a secure facility. An article of food moved to a secure facility remains under detention before, during, and after such movement.
FDA may approve a request for modification of a detention order to permit movement of a detained article of food for purposes of destruction, movement to a secure facility, preservation of the detained article of food, or any other purpose that FDA believes is appropriate. In any of these circumstances, an article of food may be transferred but remains under detention before, during, and after the transfer.
Any transfer of a detained article of food in violation of a detention order is a prohibited act.
Any person who would be entitled to be a claimant for the article of food, if seized, may appeal a detention order and, as part of that appeals process, may request an informal hearing. If a hearing is granted, an FDA Regional Food and Drug Director (RFDD) or another official senior to an FDA District Director will serve as the presiding officer at this hearing.
This final rule includes appeal and hearing timeframes for both perishable and nonperishable detained articles of food. (According to this final rule, "perishable food" means food that is not heat-treated; not frozen; and not otherwise preserved in a manner so as to prevent the quality of the food from being adversely affected if held longer than 7 calendar days under normal shipping and storage conditions.)
(See ITT's Online Archives or 06/08/04 news, 04060815, for Part II of BP summary of this final rule, which contains a link to Part I.)
FDA Contact - Kelli Giannattasio (301) 436-1432
FDA Final Rule (D/N 2002N-0275, FR Pub 06/04/04) available at http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/pdf/04-12366.pdf