FDA, U.S. Customs Issue Policy Guide for Bioterrorism Act

WASHINGTON--The Food and Drug Administration (FDA) and the U.S. Bureau of Customs and Border Protection (CBP) issued a compliance policy guide Dec. 11 describing their strategy for maintaining the safety and uninterrupted flow of food imports in accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

The policy guide (www.cfsan.fda.gov/~pn/cpgpn.html) deals with the enforcement of the act, which becomes effective Dec. 12. As the rule becomes effective, FDA and CBP expect a "good faith" effort with compliance. The policy guide clarifies that during the phase-in period, the two agencies will primarily be educating affected firms and individuals. During this period, the agencies will also impose civil monetary penalties in increasing amounts for companies and individuals not meeting the new regulations, and will ultimately begin refusing shipments. For food mailed, brought or accompanied into the United States by individuals for non-personal use, FDA and CBP will continue their education efforts and will not refuse admission because of inadequate or lack of prior notice. This phase-in period will end on Aug. 12, 2004.

"The goal of the transition policy is to provide complete clarity and education about the new import requirements, and achieve a higher level of U.S. food security without disrupting trade, said FDA Commissioner Mark B. McClellan, M.D., Ph.D. I am satisfied that this policy guide presents a realistic strategy for facilitating the flow of this essential commerce, as well as holiday food packages, while countering the threat of terrorism."

During the eight-month transitional period, the two agencies plan to take the following steps:

* Gather data to track compliance of the prior notice requirements and to determine how to best use FDA's and CBP's resources to educate industry and the public to comply with the Bioterrorism Act.

* Provide industry and the public with summary information about the level of compliance with the prior notice rules, including data on the types of errors in submitted prior notices.

* Use the data and summary information to assist the industry and the public in improving the submission of prior notice.

*Use civil monetary penalties and refusals only in response to repetitive, flagrant and other serious violations during the phase-in period.

* Post the summary information on FDA's Web site (www.fda.gov).