FDA Source
Source: FDA.gov
Four advanced scenarios covering processed products, non-FTL ingredients, food hub aggregation, and dual FDA/USDA jurisdiction.

FDA FSMA Supply Chain Examples (March 2025)

Scenario A, Peanut Butter Crackers

– Peanuts and salt are NOT on the FTL. No KDEs required for these inputs.
– Peanut butter processor: Must maintain Transformation KDEs (peanuts → peanut butter = new FTL food), assign TLC, and maintain Shipping KDEs.
– Cracker manufacturer: Must maintain Receiving KDEs for peanut butter (FTL ingredient), and Transformation + Shipping KDEs for the finished peanut butter crackers (also on the FTL because they contain nut butter in the same form).
– Downstream receivers: Standard Receiving KDEs linked to the cracker manufacturer’s TLC.

Scenario B, Fresh-Cut Apples (Non-FTL Ingredient → FTL Finished Product)

– Whole apples are NOT on the FTL. No KDEs required moving through the supply chain.
– When a processor cuts the apples, fresh-cut fruit (FTL food) is created. Transformation CTE is triggered under 21 CFR 1.1350(a)(2).
– Processor must maintain Transformation KDEs and Shipping KDEs, and assign a new TLC.
– All subsequent receivers must maintain Receiving and Shipping KDEs.

Scenario C, Fresh Melons Aggregated at a Food Hub

– Small farms grow, harvest, and cool melons, sending them unpacked to the food hub.
– Farms must maintain Growing and Cooling KDEs.
– Food Hub, Initial Packing CTE: The food hub is the initial packer and TLC Source. Must assign TLC, maintain Initial Packing KDEs, and include growing location descriptions from all farms whose melons were aggregated into each lot.
– Grocery Store, Receiving CTE: Must maintain Receiving KDEs linked to the food hub’s TLC.

Scenario D, FTL Food in a Dual Jurisdiction Facility (FDA + USDA)

– Facility receives soft cheese and makes both a fruit-and-cheese plate (FDA-regulated) and a meat-and-cheese plate (USDA-regulated).
– Single receiving room (not under exclusive USDA jurisdiction): Must maintain Receiving KDEs for ALL soft cheese received.
– FDA-regulated area (fruit and cheese plate): Must maintain Transformation KDEs and Shipping KDEs.
– USDA exclusive jurisdiction area (meat and cheese plate): Exempt under 21 CFR 1.1305(g). No records required for the USDA product.

Key Insights: Traceability obligations begin at the point of transformation, not at the origin of the raw ingredient. For food hubs: if you aggregate and pack, you own the TLC assignment and Initial Packing obligations. For dual-jurisdiction facilities: the USDA exemption only applies during and after the time the food is within exclusive USDA jurisdiction, a shared receiving point is not exempt.
How Commport Automates This: Commport's platform handles multi-SKU and multi-format supply chains, maintaining TLC linkages between peanut butter receiving records and cracker production lots, capturing Transformation KDEs the moment an EDI 856 ASN is generated for fresh-cut product, and configuring dual-jurisdiction facilities to apply traceability rules only to FDA-covered product lines.