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An interim final rule went into effect Jthat requires an additional element of information in a prior notice of imported food.

The amended regulations went into effect on May 6, 2009.Īn amendment to the regulations was also made as required by the FDA Food Safety Modernization Act (FSMA). To carry out the provisions of the Bioterrorism Act, FDA issued a final regulation amending the existing requirements in 21 CFR Part 1, Subpart I, which requires that FDA be given advance notice on shipments of imported food. food supply or other food-related emergencies. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) directs the Food and Drug Administration (FDA), as the food regulatory agency of the Department of Health and Human Services, to take additional steps to protect the public from a threatened or actual terrorist attack on the U.S.

This document also serves as FDA’s Small Entity Compliance Guide (SECG), in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121). This guide is intended to help any entity, regardless of size, to comply with the regulations that require the submission to FDA of prior notice of food, including animal feed, that is imported or offered for import into the United States. The Food and Drug Administration has prepared this guidance to restate the legal requirements set forth in 21 CFR 1.276 through 1.285 concerning prior notice of imported food under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. For this reason, FDA strongly recommends that affected parties consult the regulation at 21 CFR Part 1, Subpart I, in addition to reading this pamphlet. FDA notes, however, that the regulation that is the basis for this pamphlet establishes requirements for all covered activities. As guidance, it is not binding on either FDA or the public. This guidance document is a restatement of the Food and Drug Administration’s (FDA's) current requirements for prior notice of food presented in simplified format and language. Center for Food Safety and Applied Nutrition