Determine if you are covered

• Do you manufacture, process, pack, or hold any foods on the FDA Food Traceability List (FTL)?
• Common FTL foods: leafy greens, tomatoes, cucumbers, melons, peppers, sprouts, fresh herbs, fresh-cut produce, seafood, shell eggs, soft cheeses, nut butters, ready-to-eat deli salads.

Result: ☐ Covered – full requirements apply   ☐ Not covered – still recommended to stay informed

Critical Tracking Events (CTEs)

Mark which events apply to your operation:

• Harvesting / cooling
• Initial packing
• Receiving
• Transformation (processing, repacking, blending, cooking, etc.)
• Shipping

Key Data Elements (KDEs): record at every CTE

• Traceability Lot Code (TLC) assigned
• Product description (including variety/brand)
• Quantity and unit of measure
• Location where the event occurred (full address)
• Date and time of the event
• Business name and contact information of supplier/receiver
• Reference documents (invoice #, bill of lading, PO #, etc.)

Written Traceability Plan

• Do you have a documented Traceability Plan?
• Does it include a description of your traceability system?
• A designated Traceability Point of Contact?
• Procedures for assigning lot codes?
• A process for providing records to FDA within 24 hours?

Records & accessibility

• Records are maintained for at least 2 years
• Records can be provided to FDA within 24 hours upon request
• Mock traceability exercises conducted (recommended quarterly)

Additional best practices

• Staff trained on FSMA 204 requirements
• Suppliers and receivers informed of your traceability requirements
• System tested with a full forward + backward trace
• Corrective action procedures documented for traceability issues