What FSMA 204 Really Requires

And Why Most Systems Aren’t Ready…

The FDA’s Food Traceability Rule (FSMA 204) is prompting food companies to re-evaluate how they manage and share supply chain data. While many companies assume they’re prepared, the reality is that most systems in place today don’t meet the rule’s full requirements, especially when it comes to data sharing across supply chain partners.

FSMA 204 goes beyond basic recordkeeping. It requires that companies handling foods on the Food Traceability List (FTL) collect specific traceability data—known as Key Data Elements (KDEs)—at every Critical Tracking Event (CTE), such as receiving, transformation, shipping, and more. This data must be stored electronically, in a sortable format, and be made available to the FDA within 24 hours of request. The data must also be retained for two years.

On the surface, this may sound manageable, especially for companies already using digital tools. But the real challenge lies in how fragmented most supply chains are. In many operations, different systems are used for procurement, inventory management, transportation, and food safety. Each might track part of the required information, but they often don’t connect, and they rarely share data in the same format.

In many cases, companies find it difficult to share traceability data smoothly with their partners, including retailers and distributors. Manual file uploads, spreadsheets, and email attachments are still common. And when it comes time to respond to a regulatory request or trace a product during a recall, gathering all the necessary data quickly becomes difficult.

Most companies don’t need new systems—they need their existing systems to work together. That’s exactly what Starfish is designed to do.

Starfish helps companies and technology providers meet FSMA 204 requirements without changing the systems they already use. As a neutral connectivity layer, it enables systems to exchange traceability data in a consistent format. Once data has been translated to a consistent format, Starfish automates the task of data sharing with rules that ensure that only the right data is shared with the right partner. This provides food companies with a secure and efficient means of exchanging supply chain data, based on product movement, business relationships, and regulatory needs.

For example, if a grower ships product through a distributor to a retailer, Starfish helps ensure that each party gets the traceability data they need at the right time, without having to manually request or reformat it. And if the FDA initiates a request, the data is already organized and accessible in a compliant format so that each party can easily pull the required report.

The food industry is under increasing pressure to modernize how it tracks and shares product data. FSMA 204 makes this urgency clear. While most companies have parts of the puzzle in place, few have the ability to connect the dots across their supply chain to achieve full compliance. That’s the gap Starfish fills, quietly, in the background, making the systems already in place work together.

FSMA 204 compliance isn’t just about keeping good records. It’s about making sure those records can move with speed, clarity, and control. Most companies aren’t there yet. Starfish helps them get there.