Step 1: Determine if FSMA 204 Applies
- ☐ Identify all foods handled that appear on the Food Traceability List (FTL)
- ☐ Determine your role in the supply chain (farm, manufacturer, distributor, retailer)
- ☐ Check if any exemptions apply (very small businesses, farms below $1M in sales)
Step 2: Map Your Critical Tracking Events (CTEs)
- ☐ Identify all CTEs in your operations (receiving, transforming, creating, shipping)
- ☐ Document the flow of FTL foods through your facility
- ☐ Identify all Key Data Elements (KDEs) required at each CTE
Step 3: Implement Traceability Records
- ☐ Establish a Traceability Lot Code (TLC) system
- ☐ Implement records for all CTEs (receiving, transforming, shipping)
- ☐ Ensure records include all required KDEs
- ☐ Establish record retention for 2 years
Step 4: Establish Traceability Plan
- ☐ Develop a written Traceability Plan describing your traceability procedures
- ☐ Include a description of the foods subject to the rule
- ☐ Include a farm map (for farms) or facility map (for manufacturers)
- ☐ Make the Traceability Plan available to FDA within 24 hours upon request