FSMA Food Traceability Rule

Companies that manufacture, process, pack or hold foods on the Food Traceability List, such as leafy greens, fresh-cut fruits, shell eggs, finfish, soft cheeses and nut butters, must keep key data elements for critical tracking events including receiving, shipping and transformation, linked by traceability lot codes. They must keep a traceability plan and give FDA an electronic sortable spreadsheet within 24 hours of a request. The original January 2026 compliance date moved to 20 July 2028, and Congress directed FDA not to enforce it earlier.

The traceability rule makes lot-level data a requirement for warehouses that hold listed foods, including 3PLs and cold storage operators. Shipping and receiving events need recorded lot codes and locations that systems can export quickly. For example, a cold storage 3PL handling fresh-cut produce for grocery delivery will need to capture traceability lot codes on receiving and shipping, link them in its WMS, and produce a 24-hour sortable spreadsheet for FDA by July 2028, so system changes should be planned well ahead.

• Lot TrackingRecording batch numbers so units can be traced
• Temperature-Controlled StorageStorage kept in a set temperature range
• Warehouse Management SystemWMSSoftware that runs warehouse operations

• Food Safety Modernization Act (FSMA)2011 · 2011 law shifting FDA food safety to prevention
• Sanitary Transportation Rule2016, compliance from 2017 · FDA rule for safe transport of human and animal food

1. FDA: FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods fda.gov
2. eCFR: 21 CFR Part 1, Subpart S ecfr.gov