Under the Food Safety Modernization Act ("FSMA") proposed rule on Accreditation of Third-Party Auditors, FDA issued a draft guidance on model accreditation standards and a proposed rule on user fees for participation in the program created by the third-party auditors/certification bodies proposed rule. By these means, FDA would recognize the entities that would accredit third-party auditors to conduct food safety audits and to issue certifications. Audits and certifications for eligible foreign entities under this program will allow food importers to apply for expedited review through the Voluntary Qualified Importer Program. FDA may also require the same audits and certifications when certain food safety risks have been identified.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.