Food Traceability Rule or part 204 of Food Safety Modernization Act is the newest part of FSMA and not yet subject to enforcement. Compliance date was initially established for January 26th 2026 but in July of 2025 compliance date was extended by 30 months. New compliance date for Traceability Rule is now July of 2028.
Food Traceability Rule is included in 21 CFR Part 1 Subpart S and requires that covered facilities or individuals develop and implement traceability system that meets regulatory requirements. This regulation introduces additional traceability expectations to what is currently required by Bioterrorism Act of 2002, HACCP regulations or Food Drug Cosmetics Act.
Food Traceability Rule pertains to all foods that are included in Food Traceability List (FTL). The list is detailed and includes only certain foods that are regulated by FDA. FDA under direction of Congress compiled the list using risk based assessment. Number of factors related to foodborne illness outbreaks, recalls, costs and others were considered when developing the list. Among others foods included in the list are fruits, vegetables, soft cheese, nut butters or seafood. FDA developed a detailed list that exactly explains the type of food covered along with many exemptions.
Regulation requires that entities that handle covered food write a Food Traceability Plan that identifies Critical Tracking Events (CTE) and collect Key Data Elements (KDE) for each event. Regulation outlines the types of Critical Tracking events which include harvesting, cooling, receiving, transformation and shipping, Based on the type of operation the entity would need to determine which CTEs pertain to them and keep records with KDEs and in certain situations assign a lot number. It is important to note that food service and retail establishments are also covered by the rule, not only farms, processing, repacking or storage facilities.
FSPCA in cooperation with FDA developed standardized curriculum that explains regulatory requirements and provides formats to document required information. Bart Dobek @BDFoodSafetyConsultants recently completed Lead Instructor’s training and we are preparing to deliver public Food Traceability Training courses later this year. Stay tunned for posted dates. We will offer this training in classroom and online live formats. Additionally our team of experts can help to develop compliant Food Traceability Program. Contact us for more details.