FDA's Final Rule on Administrative Detention of Food Under the Bioterrorism Act

This is Part IV of a multi-part series of summaries of this final rule. Part IV highlights certain comments received in response to FDA's proposed rule on administrative detention as well as FDA's answers to those comments. (See future issues of ITT for additional summaries).

Highlights of Comments on FDA's Proposed Rule & FDA's Responses

In its final rule, FDA has summarized those comments received in response to its May 2003 proposed rule on administrative detention. The following are highlights of comments received and FDA's responses (partial list):

Comment 7 - FDA should work with CBP to immediately control detained shipments. One comment states that with respect to detained shipments of imported food, FDA should work with U.S. Customs and Border Protection (CBP) to immediately control these foods, and also to program CBP's Automated Commercial System (ACS) and Automated Broker Interface (ABI) to not issue a CBP release for any such shipment.

In response, FDA states that when imported food at the border is found to warrant administrative detention under section 304(h) of the Food, Drug and Cosmetic Act (FD&C Act), FDA will continue to work with CBP as the agency currently does with respect to section 801(a) of the FD&C Act.

FDA states that it will issue a detention order under 21 CFR 1.392 and 1.393, which will specify the terms of the detention. Under 21 CFR 1.393(b)(9), the order will include a statement that "the article of food is not to be consumed, moved, altered, or tampered with in any manner during the detention period, unless the detention order is first modified under 21 CFR 1.381." Accordingly, FDA does not believe it is necessary to communicate detentions through ACS or ABI.

Comment 8 - Location where imported food will be administratively detained. One comment describes FDA's current procedures of only detaining imported food at the port where the consumption entry is filed with CBP, which may not be the port of arrival. This comment states that, currently, imported food is detained at the port where the consumption entry is filed after FDA receives the declaration and the Operational and Administrative System Import Support declaration is made. This commenter wants this procedure to continue unchanged.

According to FDA, this comment describes FDA's current procedures for refusing admission under section 801(a) of the FD&C Act. FDA explains that in the event that imported food is detained administratively under section 303 of the Bioterrorism Act, the product would be detained as soon as FDA has credible evidence or information that the food product posed a threat of serious adverse health consequences or death.

FDA explains that this could presumably occur while the product was still at the port of entry where the goods arrived in the U.S. Thus, it is conceivable that FDA could administratively detain a food product at the port of entry where the arrival took place, the port of destination, or any location in between.

FDA notes that this is consistent with the purpose of administrative detention, which is to hold in place, and protect against any movement that could lead to further distribution of, the food that poses the threat of serious adverse health consequences or death to humans or animals. FDA adds that, under 21 CFR 1.393(b)(7), the detention order will specify the address and location where the article of food is to be detained and the appropriate storage conditions.

Comment 12 - Concerns over 24-hour temporary hold provisions of proposed rule. In Comment 12, FDA summarizes numerous comments received concerning the 24-hour temporary hold provisions that appeared in the May 2003 proposed rule. These comments concerned the temporary hold provision with respect to perishable food, potential wait time for trucks and drivers subject to a temporary hold, the need for guidance on the temporary hold provisions, etc.

In response to these various concerns, FDA states that the temporary hold provisions authorized in section 303 of the Bioterrorism Act are outside the scope of this final rule. FDA states that it will consider the above-described comments as it develops its approach on how best to implement this provision of the Bioterrorism Act.

Comment 17 - Need for FDA and industry to work together. FDA states that it received many comments expressing industry's motivation to cooperate with FDA and the need for FDA and industry to work together.

In response, FDA states that while these comments are outside the scope of the final rule, it agrees that it is imperative for FDA and industry to work together to protect the U.S. food supply. According to FDA, one such example of industry and FDA partnering to protect the U.S. food supply is the development of a Food Security Guidance that food producers can use if they choose to improve the protection of their products against tampering or terrorist actions. Security guidance documents for food producers, processors, importers, transporters, etc. are available at www.cfsan.fda.gov/dms/fsterr.html in addition to other food safety and terrorism resources.

Comment 22 - Publicizing issuance of administrative detention orders. Two comments state that every effort should be made to ensure that information regarding the detention of a product is accurate and publicized only when necessary in an effort to protect public health. Among other things, the comments note that such publicity could damage a company's reputation.

FDA explains that it has no plans to routinely publicize the issuance of detention orders. However, in the event of a public health emergency, FDA may issue a Talk Paper or Press Release with information regarding a detained article of food that presents a threat of serious adverse health consequences or death to humans or animals.

FDA states that in such an emergency, it may also inform other departments, agencies, or governments. In addition, administrative detentions can be precursors to enforcement action in Federal court, particularly seizures, which are public filings in the courts. FDA states that information regarding a detention could be included in the complaint for forfeiture. FDA adds that information regarding administrative detentions also may be released under a Freedom of Information Act (FOIA) request after FDA has removed any information that is protect from disclosure to the public.

(See ITT's Online Archives or 05/14/03 news, (Ref:03051410), for BP summary of the proposed rule on administrative detention.

See ITT's Online Archives or 06/09/04 news, 04060910, for Part III of BP summary of this final rule, with links to earlier installments)

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