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FDA Sets User Fees for Third-Party Certification Program for Food

The Food and Drug Administration amended its regulations to allow the collection of user fees to cover the costs of amending the Food Safety Modernization Act third-party certification program. The final rule (here) sets fees on third-party accreditation bodies that will accredit third-party certifiers. It also sets fees for when FDA directly accredits third-party certifiers, though FDA has said it will only do so if no third-party accreditation bodies have been accepted. FDA also issued a separate notice setting program user fees for fiscal year 2017 (here). FDA has said it anticipates importers will use third-party certifiers to verify their suppliers’ compliance for Foreign Supplier Verification Program purposes (see 1511190058), and will require use of third-party certifiers for importers participating in the Voluntary Qualified Importer Program (see 1611100028). This final rule on user fees, along with a recently issued guidance document (see 1612060025), were seen as final steps before the third-party certifier program could begin.

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(Federal Register 12/14/16)