21 CFR 1 Subpart S

21 CFR Part 1 Subpart S implements Section 204 of FSMA. (Subpart L is the separate Foreign Supplier Verification Programs rule.) It applies to any person who manufactures, processes, packs, or holds foods on the Food Traceability List (FTL) — leafy greens, fresh-cut fruits and vegetables, sprouts, melons, fresh herbs, fresh tropical fruits, shell eggs, nut butters, fresh and frozen finfish and crustaceans, ready-to-eat deli salads, soft and semi-soft cheese, and others. For each Critical Tracking Event (CTE) — harvesting, cooling, initial packing, shipping, receiving, transformation — the firm must capture defined Key Data Elements (KDEs) including the Traceability Lot Code (TLC), reference document identifiers, dates, quantities, and location identifiers (in many cases including geo-coordinates).

Records must be kept for two years as original paper or electronic records or true copies (21 CFR 1.1455), and made available to FDA within 24 hours of a request or within a reasonable time FDA agrees to. In outbreak, recall or other public-health situations, FDA can require certain information as an electronic sortable spreadsheet, with exemptions for some smaller entities. FDA has proposed extending the compliance date from 20 January 2026 to 20 July 2028, and Congress has directed FDA not to enforce the rule before 20 July 2028. Importers of FTL foods are also covered; foreign supplier verification is the separate Subpart L.