A plain explanation of what the rule requires, how TracAssure helps you meet it, and how we handle the data behind it.
Last updated: July 2026
The FDA's Food Safety Modernization Act Section 204 rule requires businesses that manufacture, process, pack, or hold foods on the FDA's Food Traceability List (FTL) to capture and maintain structured traceability records, and to produce them to the FDA within 24 hours of a request, in a sortable electronic format.
Records must be tied to specific Critical Tracking Events (CTEs)—the points in the supply chain where traceability data has to be captured—and must include the Key Data Elements (KDEs) required at each one.
| Critical Tracking Event | What it covers |
|---|---|
| Growing / Harvesting | Initial harvest of FTL foods from a farm or growing area |
| Cooling | First cooling of raw agricultural commodities post-harvest |
| Receiving | Any receipt of an FTL food at a new location |
| Transforming | Combining, processing, or changing the form of FTL foods |
| Creating | Creating a new food item that includes an FTL ingredient |
| Shipping | Any shipment of an FTL food to another location |
Records generally cannot live in paper logs, disconnected spreadsheets, or email chains—the FDA requires a sortable electronic format, organized by traceability lot code, and genuinely retrievable within the 24-hour window, not after a manual search.
The FDA extended the original compliance date (January 20, 2026) to July 20, 2028, giving covered operators more time to implement a durable traceability system rather than a rushed one. The extension changes the timeline—it doesn't change what the rule requires.
TracAssure is built to capture CTE and KDE data at the point of work—receiving, putaway, picking, packing, and shipping—so traceability records exist because they were captured in the normal flow of operations, not reconstructed afterward.
Your traceability data is your data. TracAssure processes it solely to provide the platform and never claims ownership over it. We use encryption for data at rest and in transit, and restrict access by role. We're still formalizing and documenting the fuller details of our security program—see our Security page for where things currently stand, and email contact@3roots.net for anything more specific you need.
TracAssure is a tool designed to help your team capture, organize, and produce the traceability records FSMA 204 requires. It significantly reduces the operational risk of manual, paper-based, or disconnected recordkeeping—but using TracAssure alone does not itself guarantee full legal compliance with FSMA 204 or any other regulation.
Your organization remains responsible for its own regulatory compliance obligations, including how the platform is configured and used at your facility. If you're uncertain whether your operation is covered by FSMA 204, or need a legal compliance determination, consult the FDA or a qualified compliance professional.
For anything not covered here—including our Privacy Policy, Terms of Service, or Data Processing Agreement—reach out to contact@3roots.net and we'll get you what you need.