A key piece of the regulatory jigsaw puzzle as FDA moves ahead with implementing the Food Safety Modernization Act (FSMA) is the voluntary, user-fee based program for the accreditation of third-party certification bodies to conduct food safety audits of foreign food facilities and issue food and facility certifications.
When this program is up and running, U.S. importers will be able to use the certifications of foreign entities to secure expedited entry of shipments under the Voluntary Qualified Importer Program (VQIP).
The final rule on Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications, published in the Federal Register on November 27, 2015, went into effect on January 26, 2016. However, the agency says it will implement the program after it releases separate Model Accreditation Standards guidance and a final user fee rule.
In July 2015, the agency issued Model Accreditation Standards draft guidance containing draft recommendations on the education and experience needed by third-party auditors and their agents. In the same month, the agency issued a separate proposed rule establishing user fees for accreditation bodies and certification bodies.
FDA does not generally plan to directly accredit third-party certification bodies. Instead, it will recognize accreditation bodies to perform that task. An accreditation body could be a foreign government agency or a private third party. The accreditation bodies will have to monitor the performance of the third-party auditors and submit reports to FDA. They must also maintain records and provide FDA access to the records.
Third-party auditors accredited under the program must conduct unannounced facility audits and notify FDA of any serious public health risk and must ensure that their agents are competent and objective.
The voluntary program allows for two kinds of audits – regulatory and consultative. Only a regulatory audit can be used for certification. A consultative audit is for internal use.
For regulatory audits, the auditor must submit an audit report to the FDA within 45 days. No report is required for a consultative audit, but any potential serious risk to public health identified in a consultative audit must be reported to FDA. All reports and notifications required to be submitted to the FDA must be submitted in English, the rule says.
FDA may grant recognition for an accreditation body of up to five years. Four years is the maximum accreditation period for certification bodies.
With many competing demands from other high-profile FSMA regulations and now with the real possibility of reduced funding in fiscal year 2017 and beyond, FDA may find itself in triage mode in terms of the speed of implementation of the various FSMA rules. But this program could play a significant future role in improving the international oversight of food safety.