FDA Issues Final Rule on Administrative Detention of Food

The Food and Drug Administration (FDA) has issued a final rule, effective July 6, 2004, which amends 21 CFR parts 1, 10, and 16 to provide procedures for the administrative detention (detention) of an article of food, if an officer or qualified employee of the FDA has credible evidence or information indicating that such article presents a threat of serious adverse health consequences or death to humans or animals.

According to the FDA, this final rule implements one of four key provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) that are primarily designed to ensure the safety and security of food. With respect to two of those provisions, the FDA has issued interim final rules requiring: (1) the registration of all foreign and domestic facilities that manufacture, process, pack or hold food that will be consumed in the U.S., and (2) the prior notice of all food imported or offered for import into the U.S.

FDA states that it plans to soon issue the fourth final rule, which will cover the establishment and maintenance of records to allow for the identification of the immediate previous sources and immediate subsequent recipients of food to help FDA track food implicated in future emergencies.

This is Part I of a multipart series of summaries of this final rule. Part I announces its availability and provides a brief overview of certain of the final rule's provisions, as follows (see future issues of ITT for additional summaries):

FDA May Detain Food as a Result of Inspection, Examination, or Investigation

Under the final rule, FDA may detain an article of food on the strength of credible evidence or information resulting from an inspection, examination, or investigation.

According to a press release, the final rule requires a detention order to be approved by the FDA District Director of the district where the detained article of food is located, or by a higher official.

FDA states that a copy of the detention order would be given to the owner, operator, and/or agent in charge of the place where the article of food is located, and to the owner of the food, provided the owner's identity can be determined readily.

The FDA adds that if it issues a detention order for an article of food located in a vehicle or other carrier, the agency must also provide a copy of the detention order to the shipper of record and the owner and operator of the vehicle or other carrier, provided the owner's identity can be determined readily.

Detained Food is Required to be Held in Secure Location, May Not be Moved Without Approval

An FDA press release states that the final rule requires detained articles of food to be held in secure locations, as determined by the FDA. The food may not be transferred from the place where it has been ordered detained, or from the place where the detained article has been removed without FDA approval, until FDA terminates the detention order, or the detention period expires.

FDA notes that a detention period may not exceed 30 days, and a violation of a detention order is a prohibited act.

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

See ITT's Online Archives or 11/10/03 and 10/15/03 news, 03111010 and (Ref: 03101510), for BP summaries of the interim final rules on prior notice and food facility registration, respectively. See ITT's Online Archives or 05/13/03 news, 03051305, for BP summary of the proposed rule on recordkeeping requirements.)

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

FDA Press Release (P04-60, dated 05/27/04) available at

http://www.fda.gov/bbs/topics/news/2004/NEW01073.html.

FDA Fact Sheet available at

http://www.cfsan.fda.gov/dms/fsbtac21.html.