The U.S. Food and Drug Administration (FDA) has released the findings of its voluntary pilot program to evaluate the alignment of private third-party food safety audit standards with the requirements set forth in both the Preventive Controls for Human Foods Rule (PCHF) and the Produce Safety Rule (PSR). The two rules were previously issued by FDA as part of Food Safety Modernization Act (FSMA) implementation.
Buyers and other stakeholders along the food supply chain often rely on third-party audits to assess the quality and safety of a product. Under FSMA, third-party audits are allowed to be used for supplier verification.
Knowing the extent to which third-party audit standards align with FSMA regulations could help give importers and receiving facilities confidence that supplier audit standards adequately address applicable FDA food safety requirements. This information, along with results of a firm’s audits, also could help inform FDA in determining risk prioritization and resource allocation.
As part of the pilot, FDA selected and assessed third-party food safety standards for alignment with the requirements in PCHF and PSR. Although the specific elements of third-party food safety standards and FSMA-implementing regulations may not be identical, alignment indicates that the relevant technical components of PCHF and PSR are being addressed.
The third-party standards reviewed by FDA and the agency’s findings are as follows:
- BRC Global Standard Food Safety and the Global Standard Food Safety, Issue 9, Interpretation Guideline: In alignment with PCHF
- FSSC 22000 Scheme 5.1 for Food Manufacturing and the FSSC 22000 V5.1 FSMA PCHF Report Addendum: In alignment with PCHF
- SQF Food Safety Code: Food Manufacturing, Edition 9 and the SQF Addendum for the Preventive Controls for Human Food: In alignment with PCHF
- GLOBALG.A.P. Integrated Farm Assurance—All Farm Base-Crops Base—Fruit and Vegetables Checklist Version 5.4-GFS and the GLOBALG.A.P. Food Safety Modernization Act Produce Safety Rule Add-On Module Version 1.2: In alignment with PSR.
FDA’s reviews focused on assessing third-party food safety standards and not the overall quality of the audit programs or the qualifications of auditors. FDA’s findings from the 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.FDA stated that, although the agency sees value in the use of third-party food safety audit standards in facilitating industry's implementation of FSMA, as well as the potential of third-party audits to inform risk prioritization, FDA does not currently have adequate resources to continue to review and evaluate the alignment of third-party food safety standards beyond the pilot.