The Food Safety Modernization Act (FSMA) of 2013 established a voluntary program for the accreditation of third-party certification bodies (CBs), which is now reaching milestones for enactment.
This program authorizes CBs to conduct food safety audits and issue certifications of foreign facilities and the foods produced for humans and animals. The requirements help ensure the competence and independence of CBs that participate in the program.
The facility certifications issued by CBs are used by importers to establish eligibility to participate in the Voluntary Qualified Importer Program (VQIP), which offers expedited review and entry of food products into the United States. While participation in the VQIP is voluntary, there are benefits to facilities and importers that become certified. VQIP provides a Food and Drug Administration (FDA)-recognized route for foreign food suppliers to demonstrate FSMA compliance to their U.S. importers. It also provides limited sampling of VQIP food entries to “for cause,” provides expedited testing (if required), and an Importers Help Desk for VQIP importers.
A facility certification also may be used by a facility as supporting evidence that the facility has a program in place to evaluate risks as required by several FDA preventive control rules. FSMA certification is valid for one year and can be re-audited by the CB and renewed annually.
To achieve accreditation by ANAB to audit and provide certification for FSMA, CBs need to meet the requirements of ISO/IEC 17021-1 or ISO/IEC 17065 and FDA’s 21 CFR Subpart M. The CB requirements include demonstration of legal authority, auditor competence, impartiality, training, self-assessments, and record keeping and reporting.
