The Food and Drug Administration’s (FDA) voluntary pilot program seeks to evaluate alignment of private third-party food safety audit standards with the food safety requirements in two regulations under the Food Safety Modernization Act (FSMA) - the Preventive Controls for Human Food (PC Human Food) and 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 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, 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.
We are launching this pilot program because we expect that FDA alignment determinations would create efficiencies for industry if they have confidence that the third-party standards used to audit their suppliers adequately consider the FDA’s food safety requirements. Similarly, we expect that it would be helpful for FDA investigators to know that the standards used to audit a supplier were aligned with FDA regulations. This could help investigators more efficiently determine whether importers and receiving facilities are in compliance with the FSMA supply-chain verification requirements for audits. The pilot will assist the FDA in gathering information to determine whether these expectations are accurate.
Throughout this pilot program the FDA will monitor 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 a determination of alignment, and whether the FDA audit comparison templates are helpful in making alignment determinations.
How to Apply
To conduct this pilot, the FDA is seeking requests for voluntary participation from members of the public, including owners of third-party human food safety standards. Upon being selected to participate in the program, participants will submit the standards for assessment. The FDA plans to select and assess up to five private third-party standards for alignment with the food safety requirements in the PC Human Food and/or Produce Safety rules. The FDA will take into account the following considerations in selecting participants:
- the order in which the requests for participation are received;
- the desired diversity of third-party human food safety standards for assessment in the pilot (e.g., PC Human Food, Produce Safety); and
- the agency's determination of available resources to conduct the assessment given the level of effort and other priorities.
The FDA may request additional information or clarification from participants in the pilot; continued participation is contingent on promptly and accurately responding to these requests.
The pilot will be conducted over the course of one year. To allow for adequate time for the FDA to complete the assessments the agency is asking that requests to participate be submitted by 30 days after the date of publication in the Federal Register. We encourage electronic submission of these requests through emails sent to StandardsAlignmentPilot@fda.hhs.gov. Written requests can also be submitted to:
Center for Food Safety and Applied Nutrition (HFS-325)
Food and Drug Administration
5001 Campus Drive
College Park, MD 20740
The request to participate should include the company name, contact name, phone number, and email address. While not required for consideration, the FDA is particularly interested in whether the contact identified is the owner of the third-party food safety standard, and the type of food safety standard (produce safety, human processed food, etc.). The agency may ask those selected to participate to submit additional information, including an audit comparison template. Participants will also be asked to provide technical feedback on the pilot to the FDA.