Is Your Business Ready for FSMA 204, The Food Traceability Rule?
Prepare your business for the Food Traceability Rule by downloading our free 7-Step Compliance Checklist.
FSMA 204, aka The Food Traceability Rule, sets additional food traceability recordkeeping responsibilities for businesses who manufacture, process, pack, or hold specific ‘high-risk’ foods that are named on FDA’s Food Traceability List. These traceability requirements are being introduced to allow for rapid identification and removal of contaminated foods.
Food manufacturers who work with foods included on the Food Traceability List will need to log KDEs and CTEs at each production stage, and must do so before the compliance deadline of July 20th, 2028.
Critical Tracking Events (CTEs): Businesses impacted by FSMA 204 need to monitor activities at certain points throughout the food supply chain, where foods are handled, moved, transformed, and may be at risk of contamination. The FDA has listed 7 CTEs in total. This includes harvesting, cooling, initial packing, first land-based receiver, shipping, receiving, and transformation.
Key Data Elements (KDEs): Organizations are required to keep a record of specific traceability data (i.e. KDEs) related to the associated critical tracking events. The data you need to provide will vary depending on the activity.
Food Manufacturers are the first line of the food supply chain. In many ways, this means that accurate food traceability recordkeeping and enhanced food transparency starts with them.
Under the Food Traceability Rule, food manufacturers may be required to document KDEs at each of the Critical Tracking Events—from harvesting to shipping and transformation.
Food manufacturers must coordinate with their suppliers to receive accurate traceability information.
It is also the responsibility of the food manufacturer to create new traceability lot codes each time a new food product is created. This lot code must link back to the original lot codes of each ingredient within it. This allows for simple and fast product recalls when an outbreak of a foodborne illness occurs.
Prepare your business for the Food Traceability Rule by downloading our free 7-Step Compliance Checklist.
Learn about the rule and the core requirements Understand your own specific food traceability duties Put a plan in place to help you comply Be part of creating a safer, more transparent supply chain 