Constituent Update

July 17, 2023

Today, the U.S. Food and Drug Administration (FDA) is announcing the findings from the voluntary pilot program to evaluate alignment of private third-party food safety audit standards with the food safety requirements in two regulations issued to implement the FDA Food Safety Modernization Act (FSMA) - the Preventive Controls for Human Food (PC Human Food) and the Produce Safety rules.

Buyers and others in the food supply-chain often use third-party audits to assess the quality and safety of a product. For example, buyers, such as importers and receiving facilities, might stipulate an audit as part of a purchase agreement. In addition, under FSMA, the PC Human Food rule, Preventive Controls for Animal Food (PC Animal Food) rule, and Foreign Supplier Verification Programs (FSVP) rule – allow for third-party audits to be used as supplier verification activities.

The FDA understands that a finding of third-party audit standards alignment with the FSMA regulations could help give importers and receiving facilities confidence that the standards used to audit their suppliers adequately address applicable FDA food safety requirements. This information, along with results of a firm’s audits, also could help inform the FDA in determining risk prioritization and resource allocation.

As part of the pilot the FDA selected and assessed third-party food safety standards for alignment with the requirements in the PC Human Food or Produce Safety rules. Although the specific elements of the third-party food safety standards and the FSMA implementing regulations may not be identical, a finding of alignment indicates that the relevant technical components of the PC Human Food or Produce Safety rules have been addressed. The reviews focused on assessing third-party food safety standards and not the overall quality of the audit programs or qualifications of auditors. The FDA’s review and the findings from this pilot do not constitute an endorsement of any one food safety audit standard, nor do they constitute an endorsement of audits conducted under such standards.

For more information about the findings and to learn more about how the pilot was conducted, visit: The FDA Concludes Voluntary Pilot Program to Evaluate Alignment of Third-Party Food Safety Standards with FSMA Rules.