New The final rule establishing procedures for administrative detention of food under the authority of the Bioterrorism Act has been issued by FDA and is to be published in the June 4 Federal Register. It differs in several ways from the proposed rule. To see a summary of these changes, click here. FDA Release, Fact Sheet Final Rules

FDA announced in a Compliance Policy Guide there will be an eight-month transition period during which the prior notice requirement for imported foods will be phased in. Until Mar. 12, 2004, FDA and Customs will not refuse admission to articles of food offered for import simply because FDA has not received an adequate prior notice for the article of food. They will refuse admission, and Customs may levy civil monetary penalties, only if there is credible evidence that an article of food presents a threat of serious adverse health consequences of death to humans or animals. The transition period will end on Aug. 12, 2004. Click Here For An Analysis of the Guide, Click Here for FDA's Prior Notice Compliance Policy Guide

Highlights of the FDA interim final rule on registration of food facilities and notice prior to import by Olsson, Frank & Weeda P.C. for U.S.A. Food Agents, LLC.

FDA Registration of Food Facilities Fact Sheet

View the entire Federal Register Notice containing FDA's interim final rule on Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. -

FDA Food Facility Registration Form (Form 3537) and Cancellation of Food Facility Registration (Form 3537a). Click here to view (PDF)

HHS Press Release on two new interim final bioterrorism rules

View the entire Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

INFORMATION ON OTHER PROPOSED RULES UNDER THE BIOTERRORISM ACT

Prepublished Prior Notice of Imported Food Shipments Interim Final Rule

FDA Prior Notice of Imported Food Shipments Fact Sheet

FDA Actions on New Bioterrorism Legislation as of January 2003 (also available in Spanish, French, Bulgarian (PDF), Croatian (PDF), Czech (PDF), Hungarian (PDF), Polish (PDF), Romanian (PDF), Russian (PDF), Serbian (Cyrillic) (PDF), Slovak (PDF), Slovene (PDF) and Ukrainian (PDF))

A proposed rule on Establishment, Maintenance, and Availability of Records Under the Bioterrorism Act would require that persons who manufacture, process, pack, transport, distribute, receive, hold or import food intended for human or animal consumption in the U.S. establish and maintain records sufficient to identify the immediate previous source and immediate subsequent recipient of such food. The Food Institute's counsel, Olsson, Frank & Weeda PC, has summarized the proposed rule, click here to view.

FDA's proposed rule, Administrative Detention of Articles of Food Under the Bioterrorism Act establishes procedures for FDA to detain an article of food, if an FDA officer or qualified employee has credible evidence or information indicating that the article presents a threat of serious adverse health consequences or death to humans or animals. Read an analysis of the proposed rule prepared for The Food Institute by Olsson, Frank & Weeda PC. Click here for analysis.


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