July 23, 2015
The FDA has published a proposed rule and a draft guidance document to support a new program under the FDA Food Safety Modernization Act (FSMA) that will help eligible foreign entities demonstrate that imported food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 (VQIP), and may also be required by FDA as a condition of granting imported food admission into the United States when certain food safety risks have been identified.
- The proposed rule would establish user fees for participation in the program created by the Accreditation of Third-Party Auditors/Certification Bodies proposed rule scheduled to become final this fall. The Accreditation of Third-Party Auditors/Certification Bodies proposed rule, as its title indicates, would establish a program through which the FDA would recognize the entities that would accredit third-party auditors (also known as certification bodies) to conduct food safety audits and issue certifications.
- The draft guidance is a set of model standards containing recommendations on the qualifications that third-party auditors/certification bodies, and their auditing agents, should have in such areas as education and experience.
Participation in the third-party accreditation program will facilitate food safety protections, benefit trade, improve efficiency of FDA oversight of imported foods, and increase efficiency and reduce costs for importers with a high level of control over the safety and security of their supply chains.
The landmark food safety law requires that a user fee program be established to assess fees and reimburse the FDA for its work in establishing and administering the third-party accreditation program. Participation in the program is voluntary for third-party auditors/certification bodies and the accreditation bodies that accredit them to audit food facilities. If the user fee proposed rule becomes final, both third-party auditors/certification bodies and accreditation bodies participating in the program would be assessed fees based on the average cost to the FDA of performing certain activities for the program (such as application review and monitoring).
FSMA also requires that the FDA issue model accreditation standards. To avoid unnecessary duplication of efforts and costs with standards already in place, in developing these draft model standards, the FDA looked at existing international standards and current practices of existing accreditation bodies.
The proposed rule and draft guidance are announced in the Federal Register and will be available for public comment for 75 days.
For More Information
- Federal Register Notice: FSMA Proposed Rule on User Fee Program to Provide for Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications
- Federal Register Notice: Draft Guidance for Industry and Food and Drug Administration Staff: Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards
- FSMA Proposed Rule on Accreditation of Third-Party Auditors