FDA’s regulations implementing the FDA Food Safety Modernization Act requirements for Preventive Controls for Human Food, Preventive Controls for Animal Food, and Foreign Supplier Verification Programs permit the use of third-party audits as supplier verification activities.
FDA’s July 13, 2020 New Era of Smarter Food Safety Blueprint indicates that to the extent third-party audit data are reliable and align with FDA’s regulatory food safety standards, FDA may use such data in risk-prioritization for FDA regulatory activities, such as inspections of both imported and domestically produced foods.
In this regard, FDA has developed templates that may help determine how well third-party audit standards align with the requirements under the PCHF, PCAF, and FSVP rules.
On October 26, 2020, FDA published notice and invited requests for participation from owners of third-party human food safety standards and others interested in participating in a voluntary pilot program for assessing third-party food safety standards for alignment with FDA’s PCHF and/or FSVP rules.
Under the pilot program, FDA plans to select and assess up to five third-party food safety standards.
The resources required to review and assess third-party standards for alignment with the PCHF and FSVP;. The ability of the pilot participants to provide adequate information to enable FDA to make a determination of alignment; and.
FDA will publish information on its website regarding the third-party standards that FDA determines to be in alignment with FDA regulations.