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Dear Colleague:
On May 27, 2004, the U.S. Food and Drug Administration (FDA), Department of Health and Human Services, issued a final regulation, entitled Administrative Detention. This final rule implements Section 303, Administrative Detention, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). This new regulation specifies procedures that FDA will use to administratively detain an article of food for human or animal consumption for which there is credible evidence or information indicating such article presents a threat of serious adverse health consequences or death to humans or animals.
This authority to administratively detain food took effect in June 2002 when the Bioterrorism Act was enacted. The Bioterrorism Act also requires FDA to provide, by regulation, procedures for instituting on an expedited basis certain enforcement actions against perishable foods subject to a detention order. FDA has now issued a final rule that includes these expedited procedures for perishable foods as well as procedures describing how FDA will detain an article of food and the process for appealing a detention order. In establishing and implementing this final rule, FDA believes it has complied fully with the U.S.'s international trade obligations, including the applicable World Trade Organization agreements and the North American Free Trade Agreement.
What is the difference between an import detention and administrative detention?
Our authority to detain food administratively under section 304(h) of the Federal Food, Drug,
and Cosmetic Act is separate and distinct from our authority to refuse admission of imported
food under section 801(a) of that act, even though refusal under section 801(a) is preceded by
an action referred to as "detention and hearing."
In section 304(h), Congress gave FDA the authority to detain food administratively where we have credible evidence or information that the article of food presents a threat of serious adverse health consequences or death to humans or animals so that we can bring such food under FDA control.
FDA's evaluation of imported foods under section 801(a) largely focuses on whether the article of food appears to have been safely produced, packed, and held; contains no contaminants or illegal additives or residues; and is properly labeled. If FDA determines that refusal under section 801(a) appears appropriate, FDA, as set out in its regulations, gives written notice to the owner or consignee (see 21 CFR 1.94(a)). In guidance dating back many years, FDA refers to this written notice as the notice of detention and hearing.
We do not, at this time, foresee frequently using administrative detention under section 304(h) to control the movement of imported food subject to section 801. When FDA determines it is appropriate to bring imported food under FDA control using the authority under section 304(h), the standard for administrative detention of imported food will be the same as it is for other food, i.e., we must have credible evidence or information that the article of food presents a threat of serious adverse health consequences or death to humans or animals.
If you have any questions regarding this correspondence, please contact Beverly Corey, D.V.M., Director, International Relations, Office of International Programs, FDA. Dr. Corey may be reached at (301) 827-4480.
Sincerely,
Melinda K. Plaisier
Assistant Commissioner for International Programs
