In the June 16, 2016, Federal Register, the FDA released a final industry guidance titled "Prior Notice of Imported Food Questions and Answers (Edition 3)." Before publishing Edition 3, FDA had issued two rules. First, a final rule in 2008 requires the submission to FDA of prior notice of food, including animal feed, imported or offered for import into the United States. Second, a final rule in 2013, in accordance with the Food Safety Modernization Act ("FSMA"), requires disclosure in the "prior notice" of the name of any country to which an article had been refused entry. The third edition addresses industry questions, clarifies previous responses, updates previous responses to reflect the 2008 rule, and includes information about FSMA's new prior notice requirement. The final guidance largely resembles the draft guidance released by the Agency on March 31, 2014.
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