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.
Foodservice and hospitality businesses who work with foods included on the Food Traceability List must take proactive steps to comply with the new rules before the enforcement deadline on the 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.
The Food Traceability Rule applies to all hospitality and foodservice providers that handle foods listed on the FLC and generate more than $250,000 per annum.
Food businesses must store key traceability data for a period of up to 24 months. When outbreaks of foodborne illnesses occur, they need to be able to provide this data to the FDA within 24 hours so accurate and well-organized recordkeeping is key.
Foodservice providers will generally be receiving foods from their suppliers and therefore must maintain key data elements related to the ‘Receiving’ CTE. Unless a supplier is exempt from complying from FSMA, this food traceability information will be provided to the foodservice provider by the supplier.
For foods that are prepared in the restaurant and sold directly to the consumer, neither Transformation nor Shipping KDEs are required.
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 