FDA Results of Pilot Program on Third Party Food Safety Standards

The Food and Drug Administration (FDA) has concluded the voluntary pilot program to evaluate alignment of private third-party food safety audit standards with applicable FDA Preventive Controls for Human Food (PCHF) and Produce Safety regulations.

FDA concluded that three third-party audit standards are in alignment with the relevant PCHF regulations and one audit standard is in alignment with select portions of the Produce Safety regulations. This development is notable because FDA’s determination gives companies in the food and beverage supply chain confidence that the third-party audits identified as aligned through this pilot are sufficient to use for compliance with the audit requirements in the PCHF and Foreign Supplier Verification Program (FSVP) regulations.

The pilot consisted of FDA selected and assessed third-party food safety standards for alignment with the requirements in the Preventive Controls for 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.

Three of the FSMA regulations – PCHF, Preventive Controls for Animal Food (PCAF), and FSVP – allow for, and sometimes require, audits to be used as a supplier verification activity. However, the rules say that audits used for this purpose must evaluate compliance with applicable FDA food safety regulations. Until now, there was no standard way to confirm that a third-party audit standard aligned with the requirements under FDA’s regulations.

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 or audits conducted under such standards.

FDA found that the following three third-party food safety audit standards are in alignment with the existing requirements of the PCHF rule:

FDA found that one third-party food safety audit standard is in alignment with existing requirements of the Produce Safety rule, excluding Subpart E related to agricultural water and Subpart M related to sprouts.

For all of these standards, the agency defined alignment based on both the main standard and an FDA-regulation specific addendum. Accordingly, only an audit that uses both of these standards would have alignment with the applicable regulation.

FDA stated in its announcement that the alignment determinations neither constitute an endorsement of any food safety audit standard, nor are the audits a substitute for FDA or state regulatory inspections for compliance with FDA regulations.

However, the agency acknowledged the findings of alignment “could create efficiencies for industry and help give importers and receiving facilities confidence that, in general, the third-party standards used to audit their suppliers adequately address applicable FDA food safety requirements. This information, along with the results of a firm’s audits also could help inform the FDA in determining risk prioritization and resource allocation.”