Enforceable Codes of Conduct:Enforceable Codes of Conduct:Accredited Third-PartyAccredited Third-PartyCertification for FoodCertification for Food

U.S. Federal Trade CommissionNovember 29, 2012

Charlotte A. ChristinU.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