The U.S. Food and Drug Administration (FDA) is launching a voluntary pilot program to evaluate alignment of private third-party food safety audit standards with the food safety requirements in two regulations under the FDA Food Safety Modernization Act (FSMA)—the Preventive Controls for Human Food (PC Human Food) and the Produce Safety rules. This pilot program will help both FDA and industry better understand how to determine 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 FDA 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. For example, 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, Preventive Controls for Animal Food (PC Animal Food), and Foreign Supplier Verification Programs (FSVP) rules—allow for third-party audits to be used as supplier verification activities.
FDA understands that determinations that third-party audit standards align with the FSMA regulations could provide importers and receiving facilities with confidence that the standards used to audit their suppliers adequately consider FDA’s food safety requirements. In addition, alignment determinations could help FDA’s investigators more efficiently determine whether importers and receiving facilities are in compliance with the FSMA supplier verification requirements.
As part of the pilot the FDA plans to select and assess up to five third-party food safety standards for alignment with the requirements in the PC Human Food and/or Produce Safety rules. The pilot will evaluate the resources required to review and assess third-party standards for alignment with the PC Human Food and Produce Safety rules, the ability of the pilot participants to provide adequate information to enable FDA to make a determination of alignment, and whether FDA audit comparison templates, available at FDA.gov, are helpful in making alignment determinations.
Alignment determinations would give those relying on audits conducted to those standards confidence that they are meeting certain FDA requirements for supplier verification audits. In addition, the pilot will enable FDA to gain information and experience that will allow the agency to evaluate the resources and tools required to conduct alignment reviews.
The pilot will be conducted over the course of 1 year. To allow for adequate time for FDA to assess the standards during the pilot period, FDA is are asking members of the public, including owners of third-party food safety standards, to submit their requests to participate by 30 days after the date of publication in the Federal Register via email to StandardsAlignmentPilot@fda.hhs.gov. Additional information about the pilot program and how to apply can be found on our website.