ANAB is recognized by the U.S. Food and Drug Administration (FDA) as an accreditation body under the Food Safety Modernization Act (FSMA) Accredited Third-Party Certification Program.
The FSMA Final Rule on Accredited Third-Party Certification establishes requirements for accreditation of third-party CBs. FSMA certifications issued under the U.S. Food and Drug Administration (FDA) third-party program are used:
- By importers for establishing eligibility of foreign suppliers for expedited review of food entry in the United States.
- For supplier verification activities under the Food Safety Verification Program and Preventive Controls rules.
- When required by FDA as a condition of entry under specific circumstances related to safety risks.
See the FDA website for compliance date of the Food Safety Verification Program.
Through the ANAB accreditation process, CBs can demonstrate conformance with and implementation of the requirements that meet stipulations under FDA's accredited third-party certification program. ANAB's program provides credibility by incorporating the requirements of ISO/IEC 17021-1 as base requirements for this program.
Please refer to the information about the accreditation process at How to Become an ANAB-Accredited Certification Body.
Accreditation oversight can be combined with any of ANAB's existing accreditation programs.
You can view the FDA FSMA application in .pdf format to understand specific requirements but the application process must be completed online via ANAB's EQM database; first-time EQM users must register to create an account.
Accreditation Requirements for Management Systems CBs
ANAB Accreditation Rule 55
CL 5316, FDA FSMA Supplemental Requirements Matrix
There are various FDA requirements for accreditation bodies to make information publicly available, including but not limited to accreditation status and information on the dates that accredited CB fees are paid. This page will be updated as CBs progress through the accreditation process with ANAB.
CB Fee Payments
CB Scope Reductions
Foreign Supplier Verification Programs
The FDA FSMA rule on Foreign Supplier Verification Programs for Importers of Food for Humans and Animals requires importers to perform certain risk-based activities to verify that food imported into the United States was produced in a manner meeting applicable safety standards.
The use of on-site audits is an option when conducting supplier verification activities under the Foreign Supplier Verification Programs and Preventive Controls rules. These audits must be conducted by "qualified auditors."
A certification body accredited by a recognized AB, such as ANAB, and listed on the FDA public registry, meets the definition of “qualified auditor” in 21 CFR 1.500, which lists the definitions applicable to FSVP.
For more information about FSMA accreditation or to obtain a quote, contact Natalia Larrimer at email@example.com.
Key Facts About the Accredited Third-Party Certification Program
Industry Resources on Third-Party Audit Standards and FSMA Supplier Verification Requirements - Includes links to templates that can be used to help receiving facilities, importers, and other stakeholders (e.g., audit programs) compare the standards used in third-party audits to FDA food safety requirements.