Key Requirements of Rule 5:
- Accreditation Bodies: Accreditation bodies must be recognized by the Food and Drug Administration (FDA) in order to accredit third-party auditors and certification bodies. These bodies must demonstrate that they have the necessary expertise, resources, and processes to effectively accredit auditors and certification bodies.
- Certification Bodies: Certification bodies must meet certain criteria to issue food safety certifications. They must be accredited by a recognized accreditation body, have qualified personnel, and use appropriate certification standards.
- Auditor Competency: Third-party auditors must be competent and qualified to conduct food safety audits. They must have the necessary knowledge, skills, and training to effectively assess food safety risks and preventive controls.
- Unannounced Audits: Rule 5 requires that at least one out of every three audits conducted by a third-party auditor be unannounced. This is to ensure that audits are conducted without prior notice, providing a more accurate assessment of the facility’s actual food safety practices.
- Audit Reports: Third-party auditors must provide the audit reports to the FDA upon request. The reports must include detailed information about the audited facility, the scope of the audit, and the findings and conclusions of the audit. The Rule also provides some exceptions. The mandatory import certification authority under FSMA does not apply to:
- Alcoholic beverages manufactured by foreign facilities under certain circumstances (detailed further within the white paper itself)
- Certain meat, poultry and egg products that are subject to U.S. Department of Agriculture oversight at the time of importation.
It is clear to see why the specific requirements of this Rule help to drive forward compliance. Importers rely on these certifications to verify the safety credentials of their foreign suppliers, and failure to comply with this Rule can result in the revocation of accreditation or certification, which can have significant financial and reputational consequences for both certification bodies and importers.