FDA Releases Final FSMA Rule on Accredited Third-Party Certification
On November 13, 2015, the U.S. Food and Drug Administration (FDA) released a final rule on Accredited Third-Party Certification. This rule is part of FDA’s implementation of the Food Safety Modernization Act (FSMA) and provides a means for foreign food facilities to obtain certification of their food safety controls. The certifications will serve two purposes:
- Importers may use the certifications to establish eligibility for participation in the Voluntary Qualified Importer Program (VQIP), which will grant expedited importation to importers that demonstrate a high level of control over the safety of their supply chain.
- FDA may require certification of certain potentially harmful foods before they may be imported into the United States.
Under FDA’s Accredited Third-Party Certification program, FDA will recognize accreditation bodies. Recognized accreditation bodies will then accredit qualified third-party certification bodies. Once accredited, certification bodies will audit and issue certifications for foreign facilities and the foods they produce.
The Third-Party Certification rule requires accreditation bodies to:
- Assess third-party certification bodies for accreditation and monitor the performance of those they accredit
- Submit monitoring reports to FDA
- Maintain and provide the FDA access to records required to be kept under the program
The rule requires certification bodies to:
- Ensure their audit agents are competent and objective
- Perform unannounced facility audits
- Notify FDA on discovering a condition that could cause or contribute to a serious risk to public health
- Verify the effectiveness of facilities’ corrective actions to address identified deficiencies
- Submit regulatory audit reports
- Maintain consultative audit reports in records, accessed only under section 414
Both accreditation bodies and certification bodies must also evaluate their own performance, correct any problems, and maintain and provide FDA access to self-assessment reports and other records.
FDA plans to implement the Third-Party Certification program as soon as possible after the agency publishes two additional documents: the final Model Accreditation Standards guidance and the final user fee rule. Once FDA implements the program, accreditation bodies will be able to apply for recognition. Certification bodies will be able to seek accreditation as soon as an FDA-recognized accreditation body begins accepting applications. If FDA does not recognize an accreditation body within two years of implementing the Third-Party Certification program, the agency may directly accredit certification bodies.
Registrar Corp assists food facilities and importers to comply with U.S. FDA regulations. We offer a Mock FDA Inspection service to help food facilities prepare for an unannounced inspection by FDA or a third-party certification body. Registrar Corp’s Food Safety Specialists will inspect everything from employee habits to the conditions of equipment and provide a detailed report to help bring your facility into compliance.
If you have questions about FDA’s Third-Party Certification rule or any other FSMA rules, contact Registrar Corp at +1-757-224-0177. Regulatory Advisors are available to chat 24-hours a day at www.registrarcorp.com/livehelp.