Date: Aug 01, 2004
In its final rule under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), the U.S. Food and Drug Administration (FDA) details the procedures it will use to detain food products, or materials that may be used in or with food products (including packaging), that the Agency believes represent an imminent threat to health and safety.
Under the act, food is defined broadly to include packaged food products, food ingredients, food additives and even packaging materials for food. Any such article may be detained "based upon credible evidence or information" indicating that it presents a threat of serious adverse health consequences or death to human or animals.
In addition to giving FDA administrative detention authority, the Act requires all food facilities, both foreign and domestic, to register with the FDA and maintain certain records, as well as notify the Agency prior to importing any food into the U.S.
Unlike the registration and import notification requirements which exempt food-contact materials, the administrative detention rules do not. FDA did not accept the argument that packaging materials should be exempt from the administrative detention requirements, even if found to present a credible threat to human health or safety. The likelihood that a packaging material could present such a threat is virtually nil.
Significantly, in issuing the final rule, FDA rejected comments that its authority should be limited to situations involving intentional adulteration, that is, actual acts of terrorism. The Agency believes that threats of serious adverse health consequences, even if they arise from unintended situations, should be similarly addressed whenever they may come to the Agency's attention. FDA has also interpreted the statute to authorize it to detain foods that have been voluntarily recalled.
FDA has long been able to seize misbranded or adulterated food in domestic commerce. However, adulterated food could enter commerce and put consumers at risk during the time it takes to file a seizure action. Under the Bioterrorism Act, FDA is now authorized to detain a food product while a seizure order is being obtained.
Also, the statute permits FDA to detain a food product for "a reasonable period," which cannot exceed 20 calendar days after the detention order is issued. However, FDA may detain the food for an additional 10 calendar days if necessary to institute a seizure or injunction action.
FDA may specify the location and condition under which the detained product is to be held. FDA may also require the detained articles to be labeled or tagged accordingly, and prohibits movement or transfer of the food product to another without the Agency's approval.
Finally, the rules establish an appeals process for contesting the detention. Once filed, FDA will hear the appeal within two calendar days after the date the appeal is filed, and will issue a decision on appeal within five calendar days from the appeal filing date.
If FDA fails to act on the appeal within five days of its filing, the detention order is terminated. If the detention order is confirmed, the food will continue to be detained until the order is terminated or the detention period expires, whichever occurs first. However, confirmation of a detention order does constitute final Agency action and may then be appealed to a U.S. District Court.
FDA does not expect to use its new detention authority to any great extent and, indeed, it has seen no need to use it even once since passage of the Act in May of 2002. We can all only hope that circumstances will continue thus and that the Agency will have little reason or need to use its authority in the future.
Used with permission. Copyright FOOD & DRUG PACKAGING, August, 2004.
For further information about this article, please contact George G. Misko at 202-434-4170 or by email at email@example.com
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