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November 17, 2008 

FDA Issues Final Rule on Prior Notice of Imported Food Products

The Food and Drug Administration has published a final rule in the Federal Register modifying the requirements for the prior notification of imported food that have been in effect since the issuance of an interim final rule in October 2003 that implemented the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 .

While the final rule made a number of changes to the interim final rule, the final rule did not make any changes to the method or deadlines for submitting the prior notice for imported food products.

The final rule, which will take effect on May 6, 2009, requires that the prior notice be submitted to FDA electronically via either U.S. Customs and Border Protection's Automated Broker Interface of the Automated Commercial System or the FDA Prior Notice System Interface (PNSI). The information must be submitted and confirmed electronically by the following deadlines:

  • For food arriving by water = 8 hours
  • For food arriving by air or land/rail = 4 hours
  • for food arriving by land/road = 2 hours
FDA has also issued a draft "Prior Notice Compliance Policy Guide" that provides detailed guidance to FDA's and CBP's staff on enforcement of the prior notice regulations. FDA is seeking public comments on the draft policy guide.

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