FDA Revises Regulations on Prior Notice for Food Imports

(World Trade Interactive)

The Food and Drug Administration has issued a final rule that makes a number of changes to its regulations on the submission of prior notice for food that is imported or offered for import into the U.S. Prior notice has been required under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) since Dec. 12, 2003. This final rule will be effective approximately May 7, 2009 (180 days after Nov. 7, the date on which the rule will be published in the Federal Register). FDA Prior Notice (259 pages PDF)

According to the FDA, the final rule requires prior notice to be submitted electronically via either the Automated Broker Interface or the FDA’s Prior Notice System Interface. As is already the case, the information must be electronically submitted and confirmed as facially complete by the FDA for review no less than 8 hours (for food arriving by vessel), 4 hours (for food arriving by air or rail) or 2 hours (for food arriving by truck) before the food arrives at the port of arrival. Food that is imported or offered for import without adequate prior notice is subject to refusal and, if refused, must be held.