November 30, 2020

Volume X, Number 335


FDA Announces a One Year Pilot Program to Evaluate Third-Party Food Safety Standards and Invites Requests to Participate

FDA’s regulations implementing the FDA Food Safety Modernization Act (FSMA) requirements for Preventive Controls for Human Food (PCHF), Preventive Controls for Animal Food (PCAF), and Foreign Supplier Verification Programs (FSVP) permit the use of third-party audits as supplier verification activities.  Additionally, FDA’s July 13, 2020 New Era of Smarter Food Safety Blueprint (discussed on our blog) 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.  FDA will evaluate:

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

Whether the audit standard comparison templates that FDA developed are helpful in making alignment determinations.

The pilot program will run through October 26, 2021 or longer, as needed.  Applications to participate are due by November 25, 2020.  FDA will publish information on its website regarding the third-party standards that FDA determines to be in alignment with FDA regulations.

© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 300



About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...