What the Food Industry Needs to Know about the FDA Food Traceability Proposed Rule

By: Hilary Thesmar, PhD, RD CFS Chief Food and Product Safety Officer and Stephanie Harris, Chief Regulatory Officer & General Counsel, FMI 

On September 23, 2020, the Food and Drug Administration (FDA) published a proposed rule "Requirements for Additional Traceability Records for Certain Foods” (Food Traceability Proposed Rule).  As you likely know, the Food Safety Modernization Act (FSMA) represented a significant change in the way food is regulated and produced with over a dozen FSMA rules that have been promulgated within the past decade. The recently released traceability proposed rule was one of the few remaining rules to be published under FSMA and represents a significant change in the recordkeeping requirements for the food industry. 

The proposed rule on food traceability is in response to Section 204 of the Food Safety Modernization Act (FSMA) and applies to those who manufacture, process, pack or hold foods on the Food Traceability List. Specifically, the proposed rule requires the food industry to establish and maintain records containing Key Data Elements (KDE) associated with different Critical Tracking Events (CTE). Additionally, the rule proposes recordkeeping requirements for high risk items on the Food Traceability List that go well beyond standard industry practices. Due to the complexity and significant impact that the proposed rule will have on standard supply chain information sharing, we encourage all FMI members to review the rule and provide input to FMI during the comment period.  

To introduce the details of the proposed rule, a webinar was held on October 21, 2020 by FMI. Our goal was to explain the proposed rule to FMI members and begin the process for obtaining feedback to inform our comments. 

The FDA is holding three virtual public meetings in November and December. FMI will be sharing thoughts at the first public meeting on November 6 and monitoring the other meetings. Pre-registration is required to participate in the public meetings through this link.

• November 6, 2020, 8:30 a.m. – 4:30 p.m. EST
• November 18, 2020, 9:30 a.m. – 5:30 p.m. EST
• December 2, 2020, 11:30 a.m. – 7:30 p.m. EST

Comments are due on November 23, 2020 on the information collection and January 21, 2020 for the proposed rule. An extension to the comment deadlines will be submitted, but it will be critical for the food industry to provide meaningful feedback to FDA to ensure a final rule is workable. 

We welcome member input on this and all other regulatory issues.  

FMI Webinar Recording and slides