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

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

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

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

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

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

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