This development is notable because if the FDA determines that certain audit standards are in alignment with the relevant FDA regulations, this would give companies relying on audits conducted to assess compliance with such standards the confidence that use of these audits meets certain FDA requirements for supplier verification audits under the PCHF and Foreign Supplier Verification Program (FSVP) regulations. The FDA is seeking participants for this pilot program, with participation requests due by 25 November 2020.2 The pilot and its goals are discussed in more detail below.
As background, there are a variety of third-party food safety standards used by industry to assess a supplier’s performance. FSVP importers and receiving facilities under the PCHF rule may choose to rely on audits to these private standards as a supplier verification activity. However, the supply-chain verification provisions of the PCHF and FSVP rules require that audits consider applicable FDA food safety regulations, and currently there is no standard way to confirm that audits conducted to evaluate compliance with these third party standards do so. This pilot will assess whether some of these third-party food safety standards are aligned with the PCHF and Produce Safety regulations such that they consider the underlying food safety regulations. If alignment is achieved, this will provide importers and receiving facilities confidence that they can use audits conducted against these standards to fulfill the PCHF and FSVP requirements for supplier verification.
The FDA plans to assess up to five third-party human food safety standards during this pilot. The agency explains that it will “use its discretion in choosing participants for assessment based on (in no particular order):
- The order the requests for participation are received;
- The desired diversity of third-party human food safety standards for assessment in the pilot (e.g., PCHF, Produce Safety); and,
- The [a]gency’s determination of available resources to conduct the assessment given the level of effort and other priorities.”
The pilot will run for one year, concluding on 26 October 2021. By the conclusion of the pilot, participants will be notified as to whether the FDA determined their food safety standard to be in alignment with the relevant FDA regulation. The FDA will publish information on its website regarding those third-party standards the agency determines to be in alignment with FDA regulations.
The FDA’s Federal Register notice announcing this initiative explains that it offers several efficiencies, including allowing industry to know whether the third-party food safety standards used to audit their suppliers adequately consider the FDA’s corresponding food safety regulations, and enabling the FDA’s investigators to know if the standard against which a supplier was audited aligns with FDA’s regulations. The pilot also will help the FDA determine what resources are necessary for the agency to review and assess third-party standards for alignment with relevant FDA regulations. To these ends, the agency notes that the goals of the pilot align with the “FDA Strategy for the Safety of Imported Food” and the “New Era of Smarts Food Safety Blueprint.” Through the New Era initiative, the agency has expressed a desire to explore the increased use of reliable audit data in risk-prioritization for FDA regulatory activities, such as inspections.
We will continue to monitor FDA’s implementation of FSMA. Should you have any questions, please do not hesitate to contact us.
1 85 Fed. Reg. 67744 (26 October 2020).
2 Requests to participate should be submitted to Franciel Ikeji and sent to StandardsAlignmentPilot@fda.hhs.gov. The request to participate should include the following information: Company and contact name, contact phone number, and contact email address. Additionally, although not required for consideration, the FDA is particularly interested in whether applicants are the owners of a third-party food safety standard, and the type of food safety standard that has been developed (e.g., produce safety, human processed food).
Authored by Maile Hermida, Elizabeth Fawell, and Mary Lancaster.