The Food Safety Modernization Act (FSMA) continues to reshape food safety regulations, and Rule 204—finalized by the FDA in 2022 and effective January 2026—is one of the most significant updates for food manufacturers and processors.

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

Who Needs to Comply?
Rule 204 applies to most domestic and foreign businesses that manufacture, process, pack, or hold foods on the FDA’s FTL, such as:

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

Exemptions
Certain businesses and situations are partially or fully exempt from Rule 204, including:

• Very small farms
• Retail food establishments with minimal direct sales
• Certain commingled raw agricultural commodities
• Foods that undergo a kill step
• Some transporters

Understanding these exemptions ensures that businesses don’t overestimate their compliance obligations while staying within regulatory requirements.

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

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

Records must be retained for two years and be provided to the FDA within 24 hours if requested.


How to Prepare
1. Identify Products on the FTL
Check the FDA’s Food Traceability List (FTL) to confirm which of your products are subject to Rule 204.
2. Map Your Supply Chain CTEs
Understand every point where your products are harvested, transformed, or moved to ensure accurate recordkeeping.
3. Implement Efficient Traceability Systems
While manual logs are still acceptable if they can be sorted and produced electronically upon request, digital traceability systems are highly recommended for efficiency. Systems that can generate reports in Excel or XML formats streamline compliance and reduce operational delays.
4. Train Your Team
Staff responsible for shipping, receiving, or processing must understand how to capture KDEs accurately.
5. Run Mock Recall Drills
Test how quickly your team can retrieve and present traceability data to identify gaps before a real recall occurs.

Recommended Tool
To simplify compliance, consider a smart traceability solution such as IQOps. Designed for food businesses, it helps:

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

Look for a system that is cloud-based, audit-ready, and adaptable to your operations.


Enforcement Timeline

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

Rule 204 is enforceable under the Federal Food, Drug, and Cosmetic Act, meaning non-compliance can result in product holds, recalls, or facility shutdowns.

Final Thoughts
FSMA Rule 204 is more than a regulatory update—it represents a shift toward a transparent and responsive food supply chain. Early preparation is the best way to ensure your facility remains compliant, efficient, and competitive.
For complete guidance, visit the FDA’s official FSMA 204 page: FDA FSMA Traceability Rule.