- Apr 29
- 4 min read
FDA’s Pilot Program on Third-Party Food Safety Standards:
What Importers Need to Know.
The U.S. Food and Drug Administration recently concluded a voluntary pilot program designed to evaluate whether widely used third-party food safety audit standards align with requirements under the Food Safety Modernization Act (FSMA). The results provide important clarity for importers, receiving facilities, and foreign suppliers that rely on third-party audits as part of their food safety and compliance programs.
Purpose of the Pilot Program
Launched under FDA’s “New Era of Smarter Food Safety,” the pilot sought to answer a critical industry question: Do third-party audit standards adequately cover FSMA requirements? FDA evaluated alignment with two foundational FSMA rules: 1) the Preventive Controls for Human Food Rule (PCHF) and 2) the Produce Safety Rule (PSR).
The intent was not to replace regulatory oversight, but to determine whether existing audit frameworks could serve as reliable tools to support FSMA compliance and supplier verification.
What “Alignment” Means
A finding of “alignment” does not mean that a standard is identical to FSMA. Rather, it indicates that the core FSMA food safety principles are addressed and the standard can function as a credible benchmarking tool. It is important to note that FDA did not evaluate auditor performance or certification bodies and alignment does not constitute FDA approval or endorsement.
Key Findings
FDA identified several globally recognized audit schemes as aligned, when paired with FSMA-specific addenda, including: BRCGS Global Standard Food Safety, FSSC 22000, Safe Quality Food (SQF) Program, and GLOBALG.A.P. for produce, with limitations. For produce operations, FDA noted that alignment may be partial, particularly in areas such as: Agricultural water, Biological soil amendments, and Sprouts. This reinforces that scope and applicability must be carefully reviewed.
What This Means for Industry
Greater Confidence in Supplier Verification. Aligned standards provide increased assurance that supplier audits address key FSMA elements, making them more useful in risk-based verification programs.
Potential Operational Efficiencies. Companies may reduce duplication between internal reviews and third-party audits, streamlining supplier approval processes.
No Replacement for FDA Oversight. Third-party audits do not replace FDA inspections or regulatory requirements. Firms remain fully responsible for compliance.
FSVP Implications: Practical Takeaways for Importers
While the pilot does not change legal obligations under the Foreign Supplier Verification Program (FSVP), it provides valuable direction on how audits can be used within an effective FSVP program.
Third-Party Audits Gain Strategic Value. Audits conducted under aligned standards can play a stronger role in supplier verification—but only when the scope matches the product and hazard profile and FSMA-specific addenda are included where applicable. Audits must be actively evaluated, not simply accepted.
Hazard Analysis Remains the Foundation. FSVP verification must still be based on known or reasonably foreseeable hazards and the supplier's performance and risks. Importers must confirm that all relevant hazards are addressed and any gaps are supplemented with additional controls or verification activities.
Alignment Does Not Equal Compliance. Certification to an aligned standard does not mean a supplier is FSMA-compliant. Importers remain responsible for conducting their own FSVP evaluation, ensuring compliance with U.S. regulatory requirements, not just certification criteria.
Scope Gaps Must Be Managed. Where alignment is partial (e.g., produce), importers should identify excluded FSMA requirements and implement gap assessments and supplemental controls.
Documentation Is Critical. FDA will expect clear records demonstrating why the audit was relied upon, how it was evaluated, and how findings were incorporated into supplier approval and monitoring.
Efficiency Is Possible—With Discipline. When properly applied, aligned audits can streamline supplier onboarding, reduce redundant verification activities, and support a more risk-based FSVP program. However, efficiency gains depend on rigorous internal review and documentation.
Strategic Value for FDA
FDA indicated that aligned audit data may help inform risk-based inspection planning, optimize allocation of regulatory resources, and enhance oversight of imported foods. This reflects FDA’s broader shift toward data-driven, preventive food safety systems.
Program Limitations
FDA has noted that it does not currently have resources to expand or continue the alignment program beyond this pilot. As a result, only evaluated standards have alignment findings. No ongoing review program is currently planned.
Key Takeaways
Third-party audits can strengthen FSVP programs, but do not replace regulatory responsibilities
Audit scope and FSMA coverage must be verified
Importers must maintain independent oversight and documentation
FDA is increasingly leveraging audit data within a risk-based framework
How We Support Our Clients
United Safety Agents helps importers move beyond “check-the-box” compliance by:
Evaluating third-party audits against FSMA requirements
Conducting FSVP gap assessments
Developing defensible, audit-ready documentation
Serving as your FSVP Importer of Record, where needed
Our goal is to ensure that your supplier verification program is not only efficient—but fully aligned with FDA expectations.
– Useful Links & Resources –
QUESTIONS & GUIDANCE
We stand ready to assist.
Email: info@unitedsafetyagents.com
Call: +1 (888) 551-7403
This material is provided for informational purposes only. The provision of this material does not constitute legal advice. Do not take action in reliance on the contents of this material without seeking the advice of appropriate council. United Safety Agents is a private, United States-based, Limited Liability Company and is not affiliated with the United States Food and Drug Administration.
Comments