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FDA Affirms Rule Requiring Prior Notice for Food to Identify Countries Refusing Entry

Wednesday, May 29, 2013
STR Client Advisory

The Food and Drug Administration has adopted as final, without change, a regulation requiring persons submitting a prior notice of imported food, including food for animals, to report the name of any country to which the food has been refused entry for food safety reasons. Failure to comply with this requirement, which was mandated by the Food Safety Modernization Act and became effective July 3, 2011, could result in the food being refused admission into the U.S.

The Bioterrorism Act of 2002 added a requirement that the FDA receive certain information about imported foods before their arrival in the U.S. The May 2011 interim final rule amended the FDA regulations implementing the BTA to add the requirement that prior notices include notice of any prior refusals. The FDA has explained that with the volume of prior notices being submitted, adding this data element would allow the agency to better identify imported food shipments that may pose safety and security risks to U.S. consumers.

The FDA has provided the following clarifying information in responses to comments made on the interim final rule.

- The reason for refusal is not required to be submitted along with the identity of the refusing country.

- “Article of food” refers only to the specific food item for which prior notice is being submitted and does not refer to food from the same batch or lot that is not being imported or offered for import into the U.S.

- While there are no specific requirements regarding documentation supporting a declaration or non-declaration of refusal of entry, in some circumstances the FDA may request documents or other information pertaining to the refusal to facilitate its review of the prior notice.

For more information on this final rule, please contact Shelly Garg at (305) 894-1043.

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