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Guidance Issuing OfficeCenter for Food Safety and Applied NutritionCenter for Veterinary MedicineOffice of Regulatory Affairs
This guidance is intended to assist industry and the Food and Drug Administration (FDA) staff by recommending standards for accrediting third-party certification bodies for the voluntary third-party certification program established under the FDA Food Safety Modernization Act (FSMA). The guidance serves as a companion document to the implementing regulations in 21 CFR parts 1, 11, and 16 that establish the framework, procedures, and requirements for accreditation bodies and third-party certification bodies for this program.
By way of background, section 307 of FSMA, Accreditation of Third-Party Auditors, amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to add section 808 (21 U.S.C. 384d) under the same name. Section 808 of the FD&C Act directs FDA to establish a voluntary program for the recognition of accreditation bodies that accredit third-party certification bodies to conduct food safety audits and issue food and facility certifications to eligible foreign entities, (including registered foreign food facilities) for the purposes specified in sections 801(q) and 806 of the FD&C Act. The statute specifies that foreign governments, agencies of foreign governments, foreign cooperatives, and other third parties meeting the eligibility criteria in the statute and FDA regulations may be accredited under the third-party certification program by an FDA-recognized accreditation body, except in limited circumstances when FDA may directly accredit third-party certification bodies.
Pursuant to section 808(b)(2) of the FD&C Act, FDA must develop Model Accreditation Standards that recognized accreditation bodies shall use to qualify third-party certification bodies for accreditation, and in so doing, look to existing standards for certification bodies (as of the date of enactment of FSMA) to avoid unnecessary duplication of efforts and costs.
On November 27, 2015, we finalized the implementing regulations establishing the framework, procedures, and requirements of the third-party certification program, including conflict of interest safeguards and other requirements necessary to ensure the competency and independence of recognized accreditation bodies and of accredited third-party certification bodies, which will help ensure the validity and reliability of certifications and other information resulting from the food safety audits conducted by accredited third-party certification bodies (80 FR 74569) (implementing regulations).
This final guidance document fulfills the statutory mandate under section 808(b)(2) of the FD&C Act that FDA must develop Model Accreditation Standards that recognized accreditation bodies shall use to qualify third-party certification bodies for accreditation. As part of these recommendations, we looked to voluntary consensus standards on accreditation that are widely used in determining the qualifications of third-party bodies that audit and certify the food industry. Specifically, we refer to International Organization for Standardization (ISO)/ International Electrotechnical Commission (IEC) recommendations contained in the ISO/IEC 17021:2011, ISO/IEC 17021: 2015, ISO/IEC 17065:2012, and/or ISO/IEC 17065:2015. In instances where recommendations that are contained in the ISO/IEC 17021:2011, ISO/IEC 17021: 2015, ISO/IEC 17065:2012, and/or ISO/IEC 17065:2015, conflict with the requirements in the statute or implementing regulations, the requirements in the statute and regulations apply.
The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.
- Accredited Third-Party Certification Program
- Accredited Third-Party Certification Program User Fees
- Imports & Exports Guidance Documents & Regulatory Information
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2011-N-0146.