Proposed Rule Accreditation of Third-Party Auditors/Certification Bodies .

Proposed RuleAccreditation of Third-Party

Auditors/Certification Bodies

http://www.fda.gov/fsma

Key Principles

• A credible third-party program will:

– Allow the agency to leverage industry audits

– help to facilitate entry of certain imported food

– create a new path for working with foreign governments

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Overview• FDA must establish voluntary program for

accrediting third-party auditors to conduct food safety audits of foreign facilities and their foods

• Key points:– Voluntary, targeted program– Certifications used for two purposes under

FSMA– Food includes pet food and non-medicated

animal feed

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Current Landscape of Food Safety Audits

• Many accreditation bodies (ABs) accredit third-party auditors/certification bodies (CBs) for food safety audits

• Many third-party CBs are auditing farms and facilities using private food safety schemes and buyer-specific requirements– Some CBs are accredited, some are not

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How FDA’s FSMA Program Would Work

FDAFDA would recognize accreditation bodies based on certain criteria

such as competency and impartiality.

Accreditation BodiesAccreditation bodies would in turn accredit qualified third-party

auditors. 

Third-Party Auditors or Certification Bodies Third-party auditors/certification bodies would audit and issue

certifications for foreign facilities and foods.

Foreign FacilityForeign facilities may choose to be audited by an accredited

auditor/certification body.5

Are Third-Party Certifications Required?

• Importers will not generally be required to obtain certifications

• In certain circumstances FDA would use certifications in determining whether:– to admit certain imported food into the U.S. that FDA

has determined, based on FSMA criteria, poses a food safety risk, or

– an importer is eligible to participate in the Voluntary Qualified Importer Program (VQIP)

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Requirements for Recognition and for Accreditation

Eligibility for Recognition: Accreditation Bodies (ABs)

• Foreign government agencies or private organizations

• Must meet requirements on authority, competency, capacity, impartiality, quality assurance, and records

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FDA Requirements for Recognized ABs

• Assessing certification bodies (CBs) for accreditation

• Monitoring performance of CBs it accredits• Monitoring its own performance• Submitting reports and notifications to FDA• Protecting against conflicts of interest• Maintaining and providing access to records

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Eligibility for Accreditation: Third-Party Auditors/CBs

• Foreign government or government agency; a foreign cooperative or other private third party

• Must meet requirements regarding authority, competency, capacity, conflict of interest, quality assurance and records

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Requirements for Accredited Auditors/CBs

• Audit agent competency

• Audit protocols– Audit against FDA (public) standards

• Notifications

• Audit reports – Consultative audit– Regulatory audits (not FDA inspections)

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FSMA Requires Notification• If, while conducting any food safety audit

under FSMA Section 307, an accredited certification body (CB) or its audit agent discovers a condition that could cause or contribute to a serious risk to the public health, the CB must notify FDA of:– The eligible entity/facility (name, address,

registration number)– The condition that led to notification

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No CB Conflicts of Interest • CB cannot own, have financial interest in,

manage, or control eligible entity seeking certification (or affiliate, parent or subsidiary)

• Financial interests of the immediate family of an officer, employee, or agent of the CB will be imputed to the officer, employee, or agent

• Audit agent cannot conduct an audit of an eligible entity the audit agent owns or operates (or affiliate, parent or subsidiary)

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FDA Oversight• Monitor performance of each AB and auditor• Removal of an AB or auditor from the program• Receive reports of every regulatory audit• Routine access to records of regulatory audits• Access to records of consultative audits (414)• Immediate notification of serious risk to public

health• Access to annual conflict of interest disclosure• May audit facility holding a certificate at any time

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Using Accredited Third-Party Auditors Under FSMA

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Use of Certifications Issued Under FSMA §307

• In meeting eligibility requirements for VQIP for expedited review and entry of food

• In providing certification or other assurances of compliance as a condition of entry for food determined by FDA to pose a safety risk under FSMA criteria

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FSVP Audits Under FSMA §301

• Neither the Third-Party nor the FSVP proposed rules would require the use of accredited auditors/CBs for §301 audits

• §301 audit would not be subject to the FSMA requirements for audits under§307– E.g., notification

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Other Opportunities

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Input from FSMA Partners Is Vital

• Proposals are opportunity for government, industry, and the public to partner with FDA in putting FSMA regulations in place

• Your comments and feedback are important to us!

• Please provide your views, questions. and concerns to help FDA finalize the rules

How to Comment on the Proposed Rules

• Go to www.regulations.gov or www.fda.gov/fsma

• Published July 29, 2013; comments due Nov. 26, 2013 (120 days)

• Comment period on produce and preventive controls proposed rules extended to Nov. 15 to enable comment on how the rules can best work together

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How to Comment on the Regulatory Impact Analysis

• Comments are being accepted separately on the Preliminary Regulatory Impact Analysis (PRIA)

• The PRIA is available at:− http://www.fda.gov/AboutFDA/

ReportsManualsForms/Reports/

EconomicAnalyses/default.htm.

Web Page: http://www.fda.gov/fsma

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