The Food and Drug Administration has published a proposed rule and a draft guidance document to support a new program under the FDA Food Safety Modernization Act that will help eligible foreign entities demonstrate that imported food meets U.S. food safety requirements. Audits and certifications for eligible foreign entities under this program will be used by importers applying for expedited review through the Voluntary Qualified Importer Program and may also be required by the FDA as a condition of granting admission into the U.S. when certain food safety risks have been identified.

Specifically, the FDA is proposing to (1) amend a July 2013 proposed rule on the accreditation of third-party auditors and certification bodies to conduct food safety audits of eligible foreign entities (including registered foreign food facilities) and issue food and facility certifications, and (2) establish a reimbursement (user fee) program to assess fees and require reimbursement for the work performed to establish and administer the system for the accreditation of third-party auditors. Comments on this proposal may be submitted by Oct. 7.

Under the July 2013 proposed rule, the FDA would recognize accreditation bodies to accredit certification bodies, except for limited circumstances in which the agency may directly accredit CBs. Among other things, the proposal includes eligibility requirements for ABs to qualify for recognition and requirements that ABs participating in the FDA program must meet as well as eligibility requirements for CBs to qualify for accreditation and requirements that CBs choosing to participate in the FDA program must meet.

The comment period on the July 2013 proposed rule closed on Jan. 27, 2014, and the FDA is currently working on the final rule. The agency indicates that because that rule has not yet been finalized, the new user fee proposed rule is based on the accreditation of third-party auditors proposed rule. When the user fee proposal is finalized, it will be aligned with the accreditation of third-party auditors final rule. The user fee proposal includes provisions on parties subject to a user fee, computation of the user fee, FDA notification to the public of annual fee rates, collection of the user fee, and consequences derived from the failure to pay a user fee.

The FDA has also issued a draft guidance document for industry and FDA staff on third-party auditor/certification body qualifications for accreditation to conduct food safety audits and issue food and/or facility certifications. In developing the draft guidance, the FDA considered several voluntary consensus standards for their relevance to the qualifications of third-party auditors/certification bodies that would certify foreign food facilities and/or their foods for conformance with the requirements of the FD&C Act. The agency also sought to identify the standards most commonly used by stakeholders (e.g., other governments, public and private accreditation bodies, the food industry and the international standards community) in qualifying third-party auditors/certification bodies for conducting food safety audits. Comments on this draft guidance document may also be submitted by Oct. 7.

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