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Dec 22, 2023
FDA Finds Four Major Third
Image credit: Sora Shimazaki via Unsplash 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
Image credit: Sora Shimazaki via Unsplash
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:
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.