On Friday FDA announced a voluntary pilot program to help the agency and industry better understand whether private third-party food safety audit standards align with the requirements in FSMA’s Preventive Controls for Human Food and Produce Safety Rules. The program, which will be conducted over one year, is part of the goals established under the New Era of Smarter Food Safety Blueprint, which states that FDA is exploring the reliability of third-party audits in ensuring food safety.
“The FDA understands that determinations that third-party audit standards align with the FSMA regulations could provide importers and receiving facilities with confidence that the standards used to audit their suppliers adequately consider FDA’s food safety requirements,” the agency stated in a constituent email update. “In addition, alignment determinations could help the FDA’s investigators more efficiently determine whether importers and receiving facilities are in compliance with the FSMA supplier verification requirements.”
During the pilot, FDA will assess up to five third-party food safety standards for alignment with the above-mentioned FSMA rules—including what resources are needed to review and assess those standards, and whether the pilot participants can provide adequate information allow FDA to determine alignment. “Alignment determinations would give those relying on audits conducted to those standards confidence that they are meeting certain FDA requirements for supplier verification audits,” FDA stated. “In addition, the pilot will enable FDA to gain information and experience that will allow the Agency to evaluate the resources and tools required to conduct alignment reviews.”
FDA is requesting those who want to participate in the program, both the public as well as owners of third-party food safety standards, submit requests in the Federal Register within 30 days.