Why the sprouter is both grower and TLC Source, and why seed suppliers are not covered.

FDA FSMA Supply Chain Examples, Sprouts (April 2024)

– Seed Grower, Seed Conditioner, Seed Supplier: Seeds are NOT on the FTL. These entities are not subject to the rule.
– Sprouter, Initial Packing CTE: The sprouter is both grower and initial packer. Must assign TLC and maintain: TLC, TLC source (packing facility location), commodity (fresh sprouts), variety, date of initial packing, quantity, growing location description, and certain KDEs related to the growing, conditioning, packing, and supplying of the seeds.
– Distributor / Retailer, Receiving & Shipping CTEs: All downstream recipients must maintain standard KDEs linked to the sprouter’s TLC.
– Traceability Plan: All covered entities must maintain a written Traceability Plan.