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 also provide 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.
In October 2020, FDA published in the Federal Register a Notice of Pilot Program: Alignment of Third-Party Food Safety Standards with Food Safety Regulations (the Notice)1 that solicited participation in a pilot program that would assess whether several third-party audit standards were aligned with certain FDA food safety regulations. Specifically, FDA said that it would assess over the course of a year up to five third-party standards, notify participants whether their standard was aligned with the relevant FDA regulation, and post on FDA’s website information regarding those standards the agency determined to be in alignment with the regulations. This initiative was aligned with FDA’s New Era of Smarter Food Safety goal of leveraging reliable audit data in risk prioritization for FDA regulatory activities.2
Pilot Program Conclusions
FDA announced the conclusion of the voluntary pilot program on July 17, 2023, nearly three years after the Notice soliciting participation was published.3 As explained by FDA, “[a]lthough 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 [PCHF] or Produce Safety rules have been addressed.” The agency’s review did not focus on the overall quality of the programs or the auditors. For example, FDA did not evaluate the general auditing policies and practices such as auditor training.
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 the existing requirements of the Produce Safety rule, excluding Subpart E related to agricultural water and Subpart M related to sprouts.
Note that 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.
In its announcement, FDA noted 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 also 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.”
Significantly, FDA does not plan to engage in further alignment evaluations, explaining that 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.” Accordingly, these four audit standards are the only ones that will have FDA-acknowledged alignment with the applicable regulation.
Why it Matters
The conclusion of the pilot program is significant because receiving facilities and importers now have confidence that they can rely on these specific audit standards when evaluating compliance with the PCHF and Produce Safety rule. In general, audits conducted according to these standards should be acceptable to meet the audit requirements in the PCHF and FSVP rules, given that they have been recognized to align with applicable FDA food safety regulations.
It also is notable that the pilot program took three years for the agency to complete, rather than the predicted one year. With that extended timeline, it is not surprising that the agency does not plan to conduct any similar evaluations for other third-party audit standards. Without the benefit of FDA’s detailed evaluation, receiving facilities and FSVP importers that rely on other audit standards do not have clear assurance that the standards are aligned with the requirements under the rule. While other standards certainly also could be aligned, further evaluation would be needed for confirmation.
Finally, it is worth keeping an eye on whether and how FDA uses the results of a firm’s audits to inform the agency in determining risk prioritization and resource allocation for purposes of regulatory inspections.
The conclusion of FDA’s pilot program is a good reminder of the requirement that supplier audits used for purposes of PCHF or FSVP compliance must evaluate compliance with FDA’s food safety regulations. Receiving facilities under PCHF and FSVP importers may want to consider reviewing their supplier audit programs in light of this announcement.
1 85 Fed. Reg. 67744 (Oct. 26, 2020). See also, HL Update, FSMA Update: FDA Announces Pilot Program to Evaluate Third-Party Food Safety Standards (Oct. 29, 2020), https://www.engage.hoganlovells.com/knowledgeservices/news/fsma-update-fda-announces-pilot-program-to-evaluate-third-party-food-safety-standards.
2 U.S. Food and Drug Administration, “New Era of Smarter Food Safety” (July 2020), https://www.fda.gov/media/139868/download.
3 U.S. Food and Drug Administration, “The FDA Concludes Voluntary Pilot Program to Evaluate Alignment of Third-Party Food Safety Standards with FSMA Rules” (Jul. 17, 2023), https://www.fda.gov/food/new-era-smarter-food-safety/fda-concludes-voluntary-pilot-program-evaluate-alignment-third-party-food-safety-standards-fsma