Meeting the November 7, 2022 deadline, the U.S. Food and Drug Administration (FDA) has submitted the Food Safety Modernization Act (FSMA) Final Rule on Requirements for Additional Traceability Records for Certain Foods to the Office of the Federal Register (OFR). Publication is managed by OFR, and FDA anticipates publication of the Traceability Final Rule within one to two weeks.

The announcement was made shortly ahead of the upcoming Food Safety Magazine webinar with FDA on the contents of the Traceability Final Rule. The webinar, which will also explore tech-enabled traceability, is the second installment of Food Safety Magazine's series with FDA, titled, “Evolution of New Era: Advancing Strategies for Smarter Food Safety.” Featuring leading voices from FDA and industry, the webinar series is an in-depth exploration of FDA's New Era of Smarter Food Safety.

During the upcoming webinar on the Traceability Final Rule, attendees will hear about the envisioned future of food traceability with the creation of standards, as well as other work by FDA to advance traceability as part of the New Era. The webinar will address topics such as:

  • What is the need for improved transparency and traceability throughout the food supply chain?
  • How will the standards set by FDA's Traceability Rule encourage greater transparency throughout the food system?
  • How can improved traceability provide real-time insight into food safety and quality, as well as supply chain efficiency?
  • How is assigning a digital identity to food products achieved, and what can industry do to mobilize these changes?
  • How can faster, more widespread adoption of traceability initiatives and technologies by industry be facilitated?
  • What other work is FDA doing to advance traceability under the New Era of Smarter Food Safety?

The webinar will take place November 29, 2022 at 2:00 P.M. ET. Speakers include Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response; Captain Kari Irvin, M.S., Deputy Director of the Office of Coordinated Outbreak Response and Evaluation (CORE) at FDA’s Center for Food Safety and Applied Nutrition (CFSAN); Katherine Vierk, M.P.H., Director of Division of Public Health Informatics and Analytics at FDA; Angela Fernandez, Vice President of Community Engagement at GS1 US; and Ed Treacy of the Produce Traceability Initiative Core Team and the International Fresh Produce Association (IFPA).

Register for the November 29 traceability webinar here.

Details of the Proposed Rule

The proposed rule is a key component of FDA's New Era of Smarter Food Safety Blueprint and would implement Section 204(d) of FSMA. The proposed requirements would help FDA rapidly and effectively identify recipients of those foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death.

At the core of the proposal is a requirement for those who manufacture, process, pack, or hold foods on the Food Traceability List (FTL) to establish and maintain records containing Key Data Elements associated with different Critical Tracking Events.  While the proposed requirements would only apply to foods on the FTL, they were designed to be suitable for all FDA-regulated food products.

The full FTL, answers to frequently asked questions, an overview of the Traceability Proposed Rule, and supplemental materials can be found on FDA's website.

Update, November 8, 2022: Details about the Food Traceability Proposed Rule were included.

Update, November 15, 2022: The Food Traceability Final Rule has been issued.