The Food Safety Modernization Act (FSMA) has been shaping the regulatory landscape for years, but Rule 204, finalized by the FDA in 2022 and going into effect in January 2026, is one of the most impactful updates for food manufacturers and processors.

What is FSMA Rule 204?
FSMA Rule 204, formally known as the Food Traceability Final Rule, requires businesses to maintain additional traceability records for foods on the FDA’s Food Traceability List (FTL). These include fresh produce, cheeses, ready-to-eat deli salads, and more.
The goal: enable faster identification and removal of potentially contaminated food from the market to prevent foodborne illness outbreaks.

Who Needs to Comply?
Rule 204 applies to most domestic and foreign firms that manufacture, process, pack, or hold foods on the FDA’s FTL. This includes:

• Food manufacturers
• Co-packers
• Cold storage and distribution centers
• Importers

Some exemptions apply, such as very small farms or retail food establishments with minimal direct sales.

What Are the Requirements?
Companies must track Key Data Elements (KDEs) at each Critical Tracking Event (CTE) in their supply chain:

• Harvesting: location, date, grower
• Receiving: traceability lot code, quantity, date
• Shipping: lot code, receiving party, shipping date

You must retain these records for 2 years and be able to provide them to the FDA within 24 hours upon request.

How to Prepare
1.Identify if your products are on the FTL:

• FDA Food Traceability List (FTL)

2.Map your supply chain CTEs

• Understand every point where your products are harvested, transformed, or moved.

3.Implement or upgrade digital traceability systems

• Manual logs won’t cut it. Digital systems that can export traceability reports in XML or Excel are key.

4.Train your team

• All staff responsible for shipping, receiving, or processing need to understand KDE capture.

5.Run mock recall drills

• Test how fast your team can retrieve and present traceability data.

Recommended Tool
To comply efficiently and avoid operational delays, consider using a smart traceability solution like IQOps. IQOps is designed specifically for food businesses and helps:

• Capture KDEs in real time
• Automate traceability logs
• Generate FSMA-compliant audit reports instantly
• Connect traceability with HACCP, recall, and supplier workflows

Make sure your system is cloud-based, audit-ready, and adaptable to your operation.

Enforcement Timeline

• Final Rule Published: November 21, 2022
• Compliance Deadline: January 20, 2026

The rule is enforceable under the Federal Food, Drug, and Cosmetic Act, meaning non-compliance could result in product holds, recalls, or facility shutdowns.

Final Thoughts
FSMA Rule 204 is not just another regulatory hurdle—it's a major shift toward a more transparent and responsive food supply chain. Early preparation is the best way to ensure your facility remains compliant and competitive.
For complete guidance, visit the FDA’s official FSMA 204 page:

• FDA FSMA Traceability Rule