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U.S. FDA Recognizes ANAB for FSMA

08 Oct 2018

IAF Member ANAB is the first accreditation body to gain recognition by the FDA for its voluntary Accredited Third-Party Certification Program.

The ANSI-ASQ National Accreditation Board (ANAB) is the first accreditation body to gain recognition by the U.S. Food and Drug Administration (FDA) for the FDA’s voluntary Accredited Third-Party Certification Program, which was established by the Food Safety Modernization Act (FSMA) to expand FDA’s oversight of imported foods.


As an FDA recognized accreditation body, ANAB has the authority to accredit third-party certification bodies (CBs) that will conduct food safety audits of foreign food entities using FDA’s safety standards and, based on their audit findings, may issue certifications of foreign food facilities and the foods they produce for people and animals.


“With the announcement of the ANSI-ASQ National Accreditation Board as the first accrediting board to be recognized, we are moving forward in our efforts to ensure parity between domestic and foreign food producers,” FDA Commissioner Dr. Scott Gottlieb said in remarks to the National Association of State Departments of Agriculture. “These certifications will be used for two purposes. First, they will establish eligibility for participation in the Voluntary Qualified Importer Program, known as VQIP, that offers expedited review and entry of food for importers who achieve and maintain a high level of control over the safety and security of their supply chains. And second, they will require that an imported product be certified in certain circumstances to keep a potentially harmful food from entering the country.”


The official recognition came about after ANAB was evaluated by FDA and successfully demonstrated conformance with all FDA requirements. ANAB has been added to the FDA Accredited Body Public Registry at https://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Importing/ucm594398.htm.

Additional information about FDA’s Voluntary Qualified Importer Program can be found at https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm361903.htm.


“We look forward to working with FDA to improve the safety of imported food. ANAB provides further credibility by incorporating the requirements of ISO/IEC 17021-1, the international standard for certification bodies providing audit and certification of management systems, as base requirements for this program in addition to FDA requirements,” Lori Gillespie, ANAB Vice President of Management Systems, said. “This will allow accreditation oversight to be combined with any of ANAB’s existing management systems accreditation programs.”


The FSMA Final Rule on Accredited Third-Party Certification establishes requirements for accreditation of third-party CBs. FSMA certifications issued under the 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.


While U.S. federal agencies such as FDA typically provide their own oversight, ANAB has advocated for government recognition of the existing conformity assessment infrastructure.


For more information about ANAB's accreditation or the FDA FSMA program, contact Natalia Larrimer at nlarrimer@anab.org or +1 414-501-5445.