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FDA Issues Interim Final Rule on Information Required in Prior Notice of Imported Food

Food Basket

Center for Food Safety and Applied Nutrition - Food and Drug Administration

May 4, 2011

The Food and Drug Administration (FDA) and the U.S. Customs and Border Protection (CBP) today issued an interim final rule on “Information Required in Prior Notice of Imported Food”. The interim final rule is a requirement of the FDA Food Safety Modernization Act (FSMA) and it amends the regulation on prior notice of imported food.

FDA issued this interim final rule to require an additional element of information in a prior notice of imported food. This change requires a person submitting prior notice of imported food, including food for animals, to report the name of any country to which the article has been refused entry.

The interim final rule, which takes effect on July 3, 2011, can help FDA make better informed decisions in managing the potential risks of food imported into the United States.
The interim final rule does not otherwise change the existing prior notice rule, such as:

  • The timeframes for submitting prior notice; i.e., information must be submitted and confirmed electronically as facially complete by FDA for review no less than 8 hours (for food arriving by water), 4 hours (for food arriving by air or land/rail), and 2 hours (for food arriving by land/road) before the food arrives at the port of arrival.
  • The ability to submit prior notice no more than 15 calendar days before the anticipated date of arrival for submissions made through FDA's Prior Notice System Interface (PNSI) and no more than 30 calendar days before the anticipated date of arrival for submission made through CBP's Automated Broker Interface of the Automated Commercial System (ABI/ACS).
  • The exclusions from prior notice, such as the exclusion for food in diplomatic pouches based on the authority in Art. 27(3) of The Vienna Convention on Diplomatic Relations (1961), which states: "The diplomatic bag shall not be opened or detained."
  • When certain conditions are met, the submission of the express consignment operator or carrier tracking number in lieu of the anticipated arrival information, Bill of Lading or Airway Bill number, and flight number.

For additional information: