It contains recommendations on their qualifications for accreditation to conduct audits and issue food and/or facility certifications under the voluntary third-party certification program under the Food Safety Modernization Act (FSMA).
The FDA issued a draft version of the guidance in July 2015.
In November 2015, the FDA final rule “Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications” established a program for the accreditation of third-party certification bodies to conduct audits and certify foreign facilities and food produced by them meet FDA requirements.
The guidance describes the standards for accreditation of third-party certification bodies as required by FSMA and the final rule.
FDA looked to existing standards to avoid duplication so refers to International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC) recommendations.
Guidance documents do not establish legally enforceable responsibilities but describe the agency’s current thinking and are only recommendations.
Certifications may be used by importers to establish eligibility for the Voluntary Qualified Importer Program (VQIP).
FDA can also require a food for import be accompanied by a certification from an accredited third-party certification body.