FDA Finalizes Prior Notice Rule and Issues Draft CPG

By Diane B. McColl & Ricardo Carvajal –  

FDA has published a final rule and a draft Compliance Policy Guide (“CPG”) on prior notice of imported food shipments under the Bioterrorism Act of 2002 (“BT Act”).  The final rule and draft CPG are available here.  The BT Act added § 801(m) to the FDC Act to require that FDA receive prior notice for food imported or offered for import into the United States.  Inadequate prior notice can lead to refusal of admission.  FDA and the U.S. Customs and Border Protection ("CBP") have operated under the terms of an Interim Final Rule (“IFR”) that they jointly issued on October 20, 2003.  The final rule will introduce some significant changes.  For example, under the IFR, prior notice cannot be submitted more than 5 calendar days before the anticipated date of arrival at the anticipated port of arrival.  Under the final rule, this period will be lengthened to 15 days for submissions made through the Prior Notice System Interface (“PNSI”), and 30 calendar days for submissions made through the Automated Broker Interface of the Automated Commercial System (“ABI/ACS”) (this change will not affect the timeframes for prior notice for food arriving by international mail).

The final rule will appear in the Federal Register on November 7, 2008, and will become effective on May 8, 2009.  FDA does not plan to adopt a phased-in approach to enforcement as it did with the IFR.  Thus, FDA can be expected to begin enforcing the final rule on May 8, 2009.  The draft CPG sets out a number of factors that FDA and CBP may consider in deciding not to take regulatory action when a food is imported or offered for import without prior notice.  These include evidence that the food is imported for non-commercial purposes, for research and analysis purposes only, or, in the case of seed, for cultivation.  Comments on the draft CPG should be submitted to Docket No. 2003D-0554 by December 8, 2008 to ensure that they receive full consideration.