FDA FSMA Supply Chain Examples (June 2023)
Scenario A, Aquacultured Tilapia Transformed into Fillets
– When a seafood processor transforms live tilapia (a RAC not previously packed) directly into fillets, they must maintain Initial Packing KDEs, not Transformation KDEs. The processor assigns the TLC and is the TLC Source. KDEs include: location, commodity (fresh tilapia fillets), quantity, date of initial packing, and harvest/growing location.
Scenario B, Canned Tomatoes (FTL Food Exiting the FTL)
– The produce processor must maintain Receiving KDEs for fresh tomatoes (FTL food).
– Since canned tomatoes are NOT on the FTL, the processor does NOT need Shipping KDEs for the canned product.
– Subsequent receivers of canned tomatoes are NOT subject to the rule.
– Written Agreements Exception: If written agreements are in place stating tomatoes will be canned (per 21 CFR 1.1305(d)(6)), entities do not need to maintain KDEs for the fresh tomatoes, but all must still maintain a Traceability Plan.
– Same rules apply to canned salmon and aquacultured canned salmon.
Scenario C, Fresh Tomatoes in Sandwich Wraps vs. Meal Kits
– Sandwich wraps (sliced fresh tomatoes + other ingredients): Processor must maintain Receiving KDEs, Transformation KDEs, and Shipping KDEs. Processor becomes new TLC Source.
– Meal kits (whole fresh tomatoes shipped directly to consumers): Processor must maintain Receiving KDEs but does NOT need Shipping KDEs, meal kits go directly to consumers, not a covered entity.
Scenario D, Imported Mangoes
– Importer does NOT take physical possession: Not covered by the rule. No KDEs required.
– Importer DOES take physical possession: Covered by the rule. Must maintain Receiving KDEs and Shipping KDEs.
Scenario E, Shell Egg Operations (three types)
– In-line operation (eggs packed where laid, no commingling): Farm is TLC Source. Maintains Initial Packing and Shipping KDEs.
– In-line farm with on-site USDA plant (all eggs processed): Exempt from the rule under 21 CFR 1.1305(d)(2).
– Off-line processor (some eggs to USDA plant, others to table market): Eggs to USDA plant are exempt. Table market eggs require full KDE compliance.
– Commingled eggs with written agreements (21 CFR 1.1305(h)(2)): Exempt from KDE requirements for commingled eggs, but Traceability Plan still required. – Registered food facilities must maintain immediate previous source / subsequent recipient records for 2 years.
– Off-line production, same company management: Not eligible for commingling exemption, full KDE compliance required.