FSMA Rule 204: The New 2028 Deadline and How it Affects Your Production

What does this 30-month extension mean for you? Whether you produce in the U.S. or export items on the Food Traceability List (FTL), you will be mandated to introduce a formal track-and-trace system. This delay isn't a "pass"—it is a window of opportunity to modernize your production before the mandate takes hold.

What is FSMA 204?

The Food Safety Modernization Act (FSMA) shifts the industry focus from reacting to foodborne illness to proactive prevention. Rule 204 specifically requires businesses to maintain detailed records to enable "field to fork" traceability.

Is Your Production Affected?

If you manufacture, process, pack, or store items on the Food Traceability List, you must comply. The list includes:

• Fresh Produce: Leafy greens, melons, tomatoes, peppers, and sprouts.
• Seafood: All finfish, crustaceans, and molluscan shellfish.
• Dairy & Deli: Soft/semi-soft cheeses, nut butters, and refrigerated deli salads.
• Eggs: Shell eggs.

Core Compliance Requirements

To meet the 2028 deadline, your production must capture Critical Tracking Events (CTEs) using specific Key Data Elements (KDEs).

• Traceability Lot Code (TLC): The essential identifier that must follow the food through every step of the supply chain.
• FDA Requests: You must be able to provide a sortable electronic spreadsheet of your traceability data within 24 hours of an FDA request.
• Traceability Plan: A written plan detailing how you assign lot codes and identify FTL foods within your facility is mandatory.
• Retention: Records must be maintained for two years.

Your Partner in the Traceability Revolution

A transition of this magnitude—moving from legacy systems to digital, interoperable tracking—requires more than just new software; it requires a foundation of experience.

With over two decades of expertise in the world of track and trace, we at FractureCode Corporation understand the technical and operational hurdles of global supply chains. The 30-month extension is the perfect time to ensure your transition is seamless, compliant, and efficient.

Don't navigate the revolution alone. Let us help you build a future-proof production line.

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