FDA Finalizes Foreign Country Refusal Prior Notice Requirement, Clarifies Definitions
The Food and Drug Administration finalized its requirement that prior notice submissions for imported food name any countries where the food shipment has been refused entry. The final rule adopts a May 2011 interim rule, without change, amending 21 CFR 1.281 (see 11050516). The requirement has been in effect since July 3, 2011, as required by Section 304 of the Food Safety Modernization Act.
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According to FDA, the fact that another country has refused admission of a human or animal food shipment can help the agency make its own decisions about admissibility into the U.S. “When the article of food has been refused entry by another country, it may have been for a reason that would also constitute a violation of U.S. law,” FDA said. “Even if it is not, this fact will be considered with other information in determining whether a product is subject to refusal of admission into the United States.”
FDA Clarifies Terms in Regulation
Although it didn’t make any changes to the interim rule, FDA did clarify some aspects of the nearly two-year-old regulation. Several comments had asked the agency to explain the scope of “any country to which the article has been refused entry,” as required by the new regulation.
Refused entry. In the preamble to the final rule, FDA said only refusals for food safety reasons, like intentional or unintentional contamination, should be reported. Commenters had expressed concern that refusal for other reasons, like labeling or noncompliance with wood packing materials, would require prior notice reporting. FDA said it will further explain its interpretation of “refused entry” in its guidance on the prior notice rule.
Article of food. Also in the preamble, FDA said it considers the term “article” to refer only to the specific food item for which prior notice is being submitted. Commenters had said FDA should clarify whether “article of food” refers to a specific shipment, or to food within the same lot or batch numbers that may be sent to other countries. FDA said it will not require reporting of refusals for food from the same batch or lot that is not being imported or offered for import into the U.S., and for which prior notice will not be submitted.
(Federal Register 05/30/13)