How to Comply with FDA’s FSMA Section 204

By Todd Gilliam, North America Industry Leader, Consumer Packaged Goods (CPG), Rockwell Automation

Are you ready to comply with the U.S. Food and Drug Association’s Food Safety Modernization Act (FSMA) requirements for Section 204?

As a food and beverage manufacturer, you know the importance of food safety, but this new rule takes it a step further. Food and beverage firms are now required to maintain records containing key data elements for critical tracking events along a food product’s life cycle.

As part of Section 204, the final rule on “Requirements for Additional Traceability Records for Certain Foods” has been published and requires compliance by Jan. 20, 2026.

This affects domestic and foreign firms producing food for U.S. consumption and requires a traceability plan (see Figure 1) for all entities throughout the food supply chain. While many larger companies may be compliant in keeping with industry best practices, smaller or mid-size companies may not have everything in place yet to track food products on the Food Traceability List (FTL), from farm to table.

Foods on the FTL include:

• Soft cheeses
• Eggs
• Nut butters
• Cucumbers
• Herbs
• Leafy greens
• Melons
• Peppers
• Sprouts
• Tomatoes
• Tropical tree fruits
• Fruits and vegetables (cut)
• Finfish
• Crustaceans
• Mollusks, bivalves
• Ready-to-eat deli salads

After confirming you manufacture, process, pack or hold a food on the FTL, confirm if you are exempt.

If you handle food on the FTL and you are not exempt, you’ll want to evaluate whether you are monitoring and capturing key data elements (KDE) at critical tracking events (CTE).

These CTEs and associated KDEs (see Figure 2) are essential data for the “sortable spreadsheets” the FDA will request in the event of contamination in a food product you handled. You will need to provide the FDA with the requested information within 24 hours, so having systems in place is imperative.

Working with your supply chain partners as you develop your traceability plan and associated processes and systems will help you figure out how to best meet the requirements together.

So, how can you connect with your partners to improve recordkeeping?

Combining equipment and solutions from Rockwell Automation, including moment-by-moment traceability using the Plex MES platform™ and collaborating with digital ID software company Kezzler, can help connect suppliers, manufacturers, logistics and consumers in one real-time traceability platform.

For a deeper dive into the requirements and information on how the Plex solution and Kezzler work together to meet food and beverage producers’ needs, sign up for the webinar from Rockwell Automation.

^{The Journal From Rockwell Automation and Our PartnerNetwork™ is published by Endeavor Business Media.}