SUBJECT: FDA’s New Food Bioterrorism Regulation: Interim Final Rule – Prior Notice of Imported Food Shipments

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) requires that FDA receive prior notice of food imported into the United States, beginning on December 12, 2003. Most of the prior notice information required by the interim final rule is data usually provided by importers or brokers to the Bureau of Customs and Border Protection (CBP) when foods arrive in the United States. Now, the Bioterrorism Act requires that this information also be provided to FDA in advance of an imported food’s arrival to the United States. FDA will use this information in advance of the arrival to review, evaluate, and assess the information, and determine whether to inspect the imported food. FDA and CBP have collaborated on the implementation of the prior notice interim final rule. Nearly all of the current imported food shipments can comply by using CBP’s Automated Broker Interface of the Automated Commercial System (ABI/ACS). Prior notice can be submitted either through ABI/ACS or FDA’s Prior Notice (PN) System Interface beginning December 12, 2003.

Customs and Border Protection contacts for the implementation of the FDA Bioterrorism Act are David Berry, Port Director, Huntsville @ 256 772-3404 or Howard Hodes, Supervisory Import Specialist, New Orleans @ 504 670-2161.