Feds Reschedule Bioterrorism Enforcement

The agencies began full enforcement of all aspects of interim prior notice rules on August 13, except for certain omissions and errors within prior notice submissions – inaccurate or missing registration numbers, invalid airway or bill of lading numbers and inaccurate consignee information, among others. For these errors, FDA and CBP will continue to use discretion in holding up shipments until November 1st.

The agencies are also delaying the projected date for issuing final prior notice rules. Originally they had intended to issue the rules in March 2005. That date has now been pushed back to June 2005.

In using discretion, FDA and CBP are paying close attention to the validity and consistency of data received. In instances where errors occur, the agencies work with submitters to improve compliance. Further, by examining areas of omission or error, the agencies hope to identify and work toward improving compliance rates through reaching out to and educating industry until the end of October.

An updated prior notice compliance summary and new “Guidance for Industry: Prior Notice of Imported Food Contingency Plan for System Outages” is available at the FDA web site, www.fda.gov

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