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FDA Announces Proposed Rule and Draft Guidance on Safety of Imported Foods

Thursday, July 30, 2015

(North American Meat Institute)

The Food and Drug Administration (FDA) published a proposed rule and draft guidance document to support a new third-party accreditation program under the Food Safety Modernization Act (FSMA) that aims to help eligible foreign entities demonstrate that imported food meets U.S. food safety requirements. The proposed rule would establish a program to accredit third-party auditors to conduct food safety audits of eligible foreign entities and to issue food and facility certifications. The rule also would institute a user fee program to assess fees and reimburse FDA for its work in implementing and administering the third-party accreditation program. Under this program, audits and certifications for eligible foreign entities will be used by importers applying for expedited review through the Voluntary Qualified Importer Program, and may be required by FDA as a condition of granting imported food admission into the U.S. when certain food safety risks have been identified. The draft guidance document provides a set of model accreditation standards containing recommendations on the qualifications that third-party auditors and their auditing agents should possess in terms of education and experience. Public comments on the proposed rule and draft guidance are due by October 7, 2015.

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