Date: Wednesday, November 5, 2008 Re:  FDA Revises Regulations on Prior Notice for Food Imports 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). 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. Following are some of the more notable changes the FDA has made to the prior notice regulations. * adds the term "manufacturer" and revises definitions for the following terms: country from which the article is shipped, food, international mail, no longer in its natural state, port of arrival, registration number and shipper * revises the period within which prior notice may be submitted from no more than five calendar days before the anticipated date of arrival to no more than (a) 15 calendar days before the anticipated date of arrival for submissions made through PNSI and (b) 30 calendar days before the anticipated date of arrival for submissions made through ABI * clarifies that prior notice must be submitted via PNSI for articles of food that have been refused under section 801(m)(1) of the BTA until such time as the Automated Commercial System or its successor system can accommodate such transactions * removes the provision stating that a registration number is not required for a facility associated with an article of food if the article is imported or offered for import for transshipment, storage and export or for further manipulation and export * removes the requirement that the identity of the anticipated border crossing within the port of arrival be provided in the prior notice * establishes the actual date the article arrived as a required data element with respect to post-refusal submissions so that the FDA knows how long it has been since the refused food shipment arrived in the U.S. and how to connect the refused prior notice to the post-refusal prior notice * adds provisions stating that for food arriving by express consignment operator or carrier when neither is the submitter or transmitter and the prior notice is submitted via PNSI, the express consignment operator or carrier tracking number may be submitted in lieu of (a) the anticipated arrival information and (b) the bill of lading or the airway bill number and flight number * deletes the requirement to provide the Harmonized Tariff Schedule number in the prior notice * clarifies that refused food must be moved under appropriate custodial bond unless immediately exported under U.S. Customs and Border Protection supervision * clarifies that refused food may be held at the port or at a secure facility outside the port and revises the timeframe for notifying the FDA of the hold location from within 24 hours of refusal to before the food is moved to the hold location The FDA has also made available a draft compliance policy guide that provides written guidance to FDA and CBP staff on the enforcement the prior notice requirement. Comments on this draft guide are due by Dec. 8.