• We reported on FDA’s October 26, 2020 notice of a voluntary pilot program under which FDA would assess whether private third-party food safety audit standards submitted in the study are aligned with food safety requirements in two FDA Food Safety Modernization Act (FSMA) regulations – the Preventive Controls for Human Food (PC Human Food) and the Produce Safety rules.  From this 2021 pilot study, FDA planned to determine whether alignment determinations could create efficiencies for industry and FDA investigators. 
  • In a July 17, 2023, Constituent Update, FDA announced the release of the findings from the voluntary pilot program.  FDA found that the three audit standards submitted in the pilot program are in alignment with the existing requirements of the PC Human Food Rule and one audit standard is in alignment with the requirements of the Produce Safety Rule, other than the requirements for agricultural water for non-sprout produce, which were not reviewed because the rule was under reconsideration when pilot submissions were received.  FDA’s finding of alignment means that while specific elements of the third-party food safety standards and the FSMA implementing regulations may not be identical, the relevant technical components of the PC Human Food Rule or Produce Safety Rule have been addressed in the submitted audit standards.  Findings from FDA’s reviews of aligned standards can be accessed on the website, The FDA Concludes Voluntary Pilot Program to Evaluate Alignment of Third-Party Food Safety Standards with FSMA Rules.  FDA notes that the findings from this pilot study do not constitute an endorsement of any one food safety audit standard, or audits conducted under such standards. 
  • FDA’s announcement reiterates that a finding of third-party audit standards alignment could help give importers and receiving facilities confidence that the standards used to audit their suppliers adequately address applicable FDA food safety requirements and, along with results of a firm’s audits, could help FDA determine risk prioritization and resource allocation.  Nevertheless, FDA concluded that it does not currently have adequate resources to continue to review and evaluate the alignment of third-party food safety standards beyond this pilot.