FDA Source
Source: FDA.gov
Two scenarios showing how FTL ingredient mixing and canning affect traceability obligations.

FDA FSMA Supply Chain Examples, Deli Salads (October 2023)

Scenario A, Deli Salad with FTL Ingredients (Fresh-Cut Celery and Onions)

– Processor must maintain Receiving KDEs for all FTL ingredients (fresh-cut celery, fresh-cut onions), including their TLCs from suppliers.
– Processor must maintain Transformation KDEs for the finished deli salad: new TLC, location, date, quantity, and TLCs of all FTL input ingredients.
– Processor must maintain Shipping KDEs when the deli salad is shipped to retail.
– All covered entities must maintain a written Traceability Plan.

Scenario B, Tuna Salad with Canned Tuna (Non-FTL Ingredient)

– Fresh tuna is on the FTL. When the seafood processor cans the tuna, it becomes a non-FTL food. The seafood processor must maintain Receiving KDEs for the fresh tuna but does NOT need Transformation or Shipping KDEs for the canned product.
– The deli salad processor does NOT need Receiving KDEs for canned tuna (not FTL). But since the finished deli salad IS on the FTL, the processor must maintain – – Transformation KDEs and Shipping KDEs for the deli salad.

Key Insight: Even when non-FTL ingredients are used, if the finished product is on the FTL, the creating entity has full traceability obligations for the finished product.
How Commport Automates ThisCommport automates receipt of TLC data from FTL ingredient suppliers via EDI 856 ASN, stores incoming TLCs as Receiving KDE records, generates a new TLC for each deli salad production lot at Transformation, and transmits that TLC and all shipping KDEs via EDI 856 ASN to retail. Commport's GDSN Datapool maintains product data for all finished deli salad SKUs.