FDA's Final Rule on Administrative Detention of Food Under the Bioterrorism Act (Part II)

This is Part II of a multi-part series of summaries of this final rule. Part II focuses on, among other things, the distinction between administrative detention provided for in section 304(h) of Food Drug and Cosmetic Act (FD&C Act) and the authority to refuse the admission of imported merchandise under section 801(a) of the FD&C Act. (See future issues of ITT for additional summaries).

FDA's Final Rule Implements Section 303 of the Bioterrorism Act

FDA explains that the final rule implements section 303 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act), which amends the seizure provision at section 304 of the FD&C Act by adding paragraph (h) to that section. This amendment grants FDA the authority to detain (i.e. prevent the further movement of) any article of food that is found during an inspection, examination, or investigation if FDA has credible evidence or information indicating that such article presents a threat of serious adverse health consequences or death to humans or animals.

(It should be noted that FDA intends to define "serious adverse health consequences" in a separate rulemaking.)

Final Rule is Not Related to FD&C Act Provisions for Refusal of Admission of Imported Food

FDA states that its authority to detain food administratively under section 304(h) of the FD&C Act is separate and distinct from its authority to refuse admission of imported food under section 801(a) of the FD&C Act.

As a result, this final rule is not related to, and does not implement, section 801(a) of the FD&C Act.

Section 801(a) of the FD&C Act provides that an article of imported food is subject to refusal of admission if it "appears, from physical examination or otherwise": (1) to have been manufactured, processed, or packed under unsanitary conditions; (2) to be forbidden or restricted in sale in the country in which it was produced or from which it was exported; or (3) to be adulterated or misbranded.

FDA Does Not Anticipate Frequent Use of Administrative Detention

FDA adds that, at this time, it does not foresee frequently using administrative detention under section 304(h) of the FD&C Act to control the movement of imported food subject to section 801 of the FD&C Act.

Moreover, when FDA determines it is appropriate to bring imported food under FDA control using the authority under section 304(h) of the FD&C Act, the standard for administrative detention will be the same as it is for other products (i.e., FDA 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).

Final Rule Reflects Changes Regarding CBP Terminology

In the preamble to its final rule, the FDA details changes made between the proposed and final versions of this rule. Among other things, the final rule reflects changes to the proposed rule in order to avoid confusion with U.S. Customs and Border Protection (CBP) terminology and requirements, as follows:

Term "limited conditional release" dropped. FDA explains that the proposed rule used the term "limited conditional release" to refer to the process whereby FDA grants a request to modify a detention order to permit movement of a detained article of food. The term "limited conditional release" has a different meaning as used by CBP. In order to avoid confusion, FDA has eliminated the use of this term, and instead uses the term "request for modification of a detention order."

Customs bond does not prohibit movement of detained articles at FDA's direction. The FDA has also made a change to proposed 21 CFR 1.381(a). FDA explains that this section could have been misinterpreted to prohibit delivery of an article to a storage facility just because it is under a customs bond (as opposed to a penal bond). In the final rule, 21 CFR 1.381(a) has been revised to make clear that the existence of an appropriate customs bond required by Customs law and regulations does not prohibit movement of a detained article at FDA's direction.

Bioterrorism Act's Provision for Temporary Hold at Ports is Not Addressed in this Final Rule

According to the FDA, section 303 of the Bioterrorism Act also includes a provision authorizing temporary holds at ports of entry that is not addressed in this final rule. FDA explains that the temporary hold provision authorizes FDA to ask the Secretary of the Treasury to institute a temporary hold for up to 24 hours on an article of food offered for import at a U.S. port of entry if FDA has credible evidence or information indicating that an article of food presents a threat of serious adverse health consequences or death to humans or animals, and the FDA is unable immediately to inspect, examine, or investigate such article.

FDA states that it has received comments on the temporary hold provision in the public docket of this final rule and notes that it plans to consider these comments as it develops an approach on how best to implement this provision of the Bioterrorism Act.

(See ITT's Online Archives or 06/07/04 news, 04060715, for Part I of BP summary of this final rule.)

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