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 regulations. For the pilot, the 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.
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.
The findings from the reviews of aligned standards can be accessed by clicking on the links in each box of the table below.
|Third-Party Food Safety Audit Standard and Applicable Addendum||Scope Name|
|BRC Global Standard Food Safety plus the Global Standard Food Safety, Issue 9, Interpretation Guideline||Preventive Controls for Human Food (PCHF)|
|FSSC 22000 Scheme 5.1 for Food Manufacturing plus the FSSC 22000 Version 3 FSMA PCHF Report Addendum||Preventive Controls for Human Food (PCHF)|
|SQF Food Safety Code: Food Manufacturing, Edition 9 plus the SQF Addendum for the Preventive Controls for Human Food||Preventive Controls for Human Food (PCHF)|
|GLOBALG.A.P. Integrated Farm Assurance – All Farm Base-Crops Base – Fruit and Vegetables Checklist. Version 5.4-1-GFS plus the GLOBALG.A.P. Food Safety Modernization Act Produce Safety Rule Add-on Module Version 1.3||Produce Safety Rule (PSR)
*Did not include Subpart E, related to Agricultural Water (as applicable to non-sprout produce) or Subpart M, related to sprouts
Third-party audits under these food safety audit standards and applicable addenda are not a substitute for FDA or state regulatory inspections for compliance with FDA regulations, including the Preventive Controls for Human Food Rule or the Produce Safety Rule. FDA’s statements regarding alignment of the standards referenced in the table above apply only to the specified audit standards and addenda listed.
How the Pilot was Conducted
The FDA undertook the voluntary pilot 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 Produce Safety rules. This pilot program was launched to help both FDA and industry gain a better understanding of whether these standards align with FDA regulations, a goal that is consistent with the New Era of Smarter Food Safety Blueprint. The Blueprint, published on July 13, 2020, explains that the Agency is looking to explore how reliable third-party audits can help ensure food safety, including the use of audit data in risk prioritization for FDA regulatory activities.
Buyers and others in the food supply-chain often use third-party audits to assess the quality and safety of a product. Buyers, such as importers and receiving facilities, might stipulate an audit as part of a purchase agreement. In addition, three FSMA regulations - 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 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 results of a firm’s audits also could help inform the FDA in determining risk prioritization and resource allocation.
Throughout this pilot program the FDA monitored the resources required to review and assess third-party standards for alignment, the ability of the pilot participants to provide adequate information to enable FDA to make alignment findings, and whether the FDA audit comparison templates were helpful in developing such findings.
While the FDA sees value in the use of third-party food safety audit standards in facilitating industry's implementation of FSMA, and the potential of these audits to inform risk prioritization, the Agency does not currently have adequate resources to continue to review and evaluate the alignment of third-party food safety standards beyond this pilot. The FDA will continue to assess future opportunities to leverage third party audit standards to help meet the agency’s public health mission.