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Implementing Enforceable Codes of Conduct: Third-Party Certification for Food Safety

This article discusses the importance of accredited third-party certification for food safety and the need for enforceable codes of conduct. It also covers the Federal Trade Commission's guidelines and the Food Safety Modernization Act's requirements for third-party auditors and laboratories. The article emphasizes the need to address conflicts of interest and ensure transparency in the certification process.

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Implementing Enforceable Codes of Conduct: Third-Party Certification for Food Safety

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  1. Enforceable Codes of Conduct:Accredited Third-PartyCertification for Food U.S. Federal Trade Commission November 29, 2012 Charlotte A. Christin U.S. Food and Drug Administration

  2. Food Safety Modernization Act (2011) • Third-Party Auditors • Establish program for accreditation of third-party auditors (CBs) to conduct food safety audits and to issue food and facility certifications • Issue model standards to qualify CBs for accreditation • Laboratories • Establish program for recognition of laboratory accreditation bodies • Issue model standards

  3. FSMA Third Parties: Conflicts of Interest • CB cannot be owned, managed, or controlled by a person that owns or operates an entity (facility) to be certified • CB must have procedures to ensure against using officer or employee with financial conflict of interest re: facility • CB must annually disclose to FDA its compliance with conflict of interest requirements

  4. FSMA Third Parties: Conflicts of Interest • Audit agent may not conduct a regulatory (certification) audit or consultative audit at a facility the agent owns or operates • Audit agent must follow procedures to no financial conflict of interest with the facility to be audited • Audit agent must annually disclose its compliance with conflict of interest requirements • Audit agent may not conduct a certification audit for a facility within 13 months of conducting another audit there; waiver allowed

  5. FSMA Third Parties: Conflicts of Interest • Implementing regulations must • Require unannounced audits • Include structure to decrease the potential for conflicts of interest, including timing and public disclosure, for fees paid • Contain appropriate limits on financial affiliations

  6. FSMA Third Parties: Transparency • Audit reports • Submitted in a manner/form determined by FDA (certification audit) • Records access • Depends on type of audit: for certification or consultative purposes • Publicly available registry • Recognized accreditation bodies • Accredited third-party auditors

  7. FSMA Third Parties: Implementation • Statutory mandate • Voluntary program • Existing standards • Global reach • Diverse stakeholders/interests • Existing programs • Previous experiences • FDA mission

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