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UPDATED: 5/7/05

FDA Final Rule on Detention

Per Federal Register June 4, 2004

An officer or qualified employee of FDA may order the detention of food articles for up to 30 days after the importation if they have "credible" evidence or information to believe that the article presents a threat of serious harm 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;

The Final Rule will cover all food products, whether in intrastate or interstate commerce;

Domestic or imported food may be detained for up to a period of 30 days;

FDA may specify that the detained merchandise be held in a specific, secure location and may require that the detained food articles be labeled with official FDA tags and labels to include, among other information, a statement that the 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 and criminal act;

FDA will state in the detention order, among other things, the name of the authorized

FDA representative who approved the detention, the location and any applicable conditions under which the food is to be held;

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 article, or any other purpose that FDA believes is appropriate;

Any person with an interest in the food article may request an informal hearing and file an appeal against the detention;

If a hearing is granted, an FDA Regional Director or another official senior to an FDA District Director will serve as the presiding officer of the hearing;

Subsequent to the hearing, the presiding officer must issue a written report of the hearing, including a proposed decision with a statement of reasons. The hearing participant may review the report and suggest changes before the presiding officer issues a final agency decision;

Time frames for filing an appeal will vary depending on whether or not the food articles are "perishable," yet other procedural timeframes surrounding the appeal are uniform for both perishable and non-perishable items;

There are expedited procedures for initiating certain enforcement actions regarding perishable foods; and

Confirmation of a detention order by FDA's presiding officer is considered final agency action.

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