FDA's Final Rule on Administrative Detention of Food Under the Bioterrorism Act
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.
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This is Part VI, the final installment of a multipart series of summaries of this final rule. Part VI lists the subtitles and sections of new Subpart K to 21 CFR Part 1, which is entitled, "Administrative Detention of Food for Human or Animal Consumption."
Highlights of Regulations Contained in New Subpart K to 21 CFR Part 1
This final rule adds a new Subpart K to 21 CFR Part 1. The subtitles (in bold) and sections contained in this new subpart consist of the following:
General Provisions -
Section 1.377. What definitions apply to this subpart?
Section 1.378. What criteria does FDA use to order a detention?
Section 1.379. How long may FDA detain an article of food?
Section 1.380. Where and under what conditions must the detained article of food be held?
Section 1.381. May a detained article of food be delivered to another entity or transferred to another location?
Section 1.382. What labeling or marking requirements apply to a detained article of food?
Section 1.383. What expedited procedures apply when FDA initiates a seizure action against a detained perishable food?
Section 1.384. When does a detention order terminate?
How Does FDA Order a Detention -
Section 1.391. Who approves a detention order?
Section 1.392. Who receives a copy of the detention order?
Section 1.393. What information must FDA include in the detention order?
What is the Appeal Process for a Detention Order -
Section 1.401. Who is entitled to appeal?
Section 1.402. What are the requirements for submitting an appeal?
Section 1.403. What requirements apply to an informal hearing?
Section 1.404. Who serves as the presiding officer for an appeal, and for an informal hearing?
Section 1.405. When does FDA have to issue a decision on an appeal?
Section 1.406. How will FDA handle classified information in an informal hearing?
(See ITT's Online Archives or 06/18/04 news, 04061810, for Part V of BP's summary of this final rule, with links to earlier summaries.)
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