Enforceable Codes of Conduct: Accredited Third-Party Certification for Food

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