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Customs Update by Susan Kohn Ross

FDA'S automatic detention rules

Updated 4:47 p.m. ET, Wed Jul 7, 2004

The JOURNAL of COMMERCE ONLINE  (edited for size)

The Food and Drug Administration's new automatic detention rules, published in the June 4 Federal Register, took effect July 6. Regretfully bearing the same name as the existing procedure for holding up goods if they are subject to an Import Alert, in implementing the 2002 Bioterrorism Act, FDA also must implement rules which allow it to hold food imports which have been reported through the prior notice system but may not yet have been offered for entry.

Detention in this context may be ordered by an FDA officer of any food found during an inspection, examination or investigation if there is "credible evidence or information indicating that the article of food presents a threat of serious adverse health consequences or death to humans or animals." FDA states the definition of serious adverse health consequences will be undertaken in a separate rulemaking.   FDA may order the shipment detained up to 30 days. Detained goods must be held in the location and under the conditions specified by FDA.  If FDA believes special transportation conditions must be followed, the detention order will contain those instructions as well. Failure to follow FDA's directions is considered a prohibited act which could result in criminal prosecution, a civil fine and/or debarment.

Importers may not take possession of detained food, although they may direct its storage in accord with FDA's directions. If shelf-life or other legitimate commercial reasons require a change to the ordered storage conditions, FDA provides a procedure allowing importers to seek a modification to an existing detention order, for example allowing food to move from refrigerated to frozen storage. Any such requests must be made in writing and directed to the FDA representative who approved the detention order.

The detained foodstuff is to be marked with a statement of detention; a statement that the food must not be consumed, moved, altered, or tampered with for the period stated; a statement that violation of a detention order or the removal of its tags or labels is a prohibited act punishable by a fine or imprisonment or both; the detention order number, date and hour of the order; the detention period, and the name of the FDA representative ordering the detention.  If FDA decides to seize detained food, it is required to send the paperwork to the Dept. of Justice within four (4) calendar days after the detention order is issued.  Detention orders expire when the detained goods are released by FDA. If no action is taken within the detention period, when that period expires, the detention is considered terminated.