Strategic Steps to Prepare for FSMA 204 Traceability Rule as Deadline Looms

By Liz Sertl

With the deadline for the U.S. FDA’s Food Safety Modernization Act (FSMA) Rule 204 rapidly approaching, food safety professionals across the food sector face an urgent need to implement effective traceability systems. The enhanced requirements for high-risk foods are not only transforming how organizations manage data but also underscoring the critical role of interoperability and data quality in meeting these new requirements.

As of January 20, 2026, businesses across the supply chain must be equipped to collect and share specific traceability data for designated high-risk foods, including leafy greens, seafood, cheeses, and many others. For processors, manufacturers, distributors, and retailers, the stakes are high.

Accurate identification

One of the primary challenges in meeting FSMA Rule 204 requirements is the need for sharing accurate data across complex and diverse supply chains. Standards like those provided by GS1 can help ensure that critical tracking events (CTEs) and key data elements (KDEs) can be shared in a consistent, actionable format. Without this, organizations risk data silos, delays, and errors that undermine traceability efforts.

By adopting standardized identifiers like Global Trade Item Numbers (GTINs), organizations can link product information across supply chain partners with increased efficiency. Additionally, standardized formats for recording and sharing KDEs—such as batch numbers, lot codes, and production dates—enable faster and more accurate responses to safety incidents.

Failing to implement effective traceability systems by the January 20, 2026,  can lead to costly recalls, supply chain delays, and reputational damage.

Capturing and sharing quality data

The success of any traceability initiative depends on the quality of the data being captured and shared. High-quality data ensures that information is accurate, complete, and readily accessible. Conversely, poor data quality can lead to costly errors, such as misidentification of products during recalls or delays in tracing the source of contamination.

The ability to rapidly access and share accurate traceability data is more critical than ever under FSMA Rule 204. A key feature of the U.S. FDA’s updated requirements is the mandate for businesses to provide records within 24 hours of an official request. This provision emphasizes the urgency of having robust, efficient traceability systems in place.

Key elements of data quality include:

• Accuracy: Correctly identifying and recording KDEs to minimize errors
• Consistency: Ensuring data remains uniform across all partners and platforms
• Timeliness: Capturing and sharing data in real-time to support rapid decision-making

Strategic steps for implementation

To meet FSMA Rule 204 requirements and ensure readiness before the deadline, food safety professionals should consider these strategic steps:

1. Evaluate Current Systems: Conduct a thorough assessment of existing traceability capabilities. Identify whether your current systems align with FSMA Rule 204’s requirements for tracking and sharing KDEs. Use this evaluation to pinpoint areas for improvement.

2. Implement Standards for Interoperability: Integrate standards into your operations to standardize data collection and sharing across supply chain partners. Standards can provide a common language for identifying, capturing, and sharing product information.

3. Collaborate Across the Supply Chain: Engage your supply chain partners early to ensure a shared understanding of FSMA Rule 204 requirements. Collaborative efforts, such as joint training sessions and shared digital tools, can improve alignment and efficiency.

4. Investigate Technology Solutions: Investigate digital solutions, such as blockchain platforms, ERP systems, or cloud-based traceability tools, to automate data collection and sharing. Electronic Product Code Information Services (EPCIS), a global standard that facilitates the seamless capture and sharing of event-based supply chain data, is a powerful tool that assures interoperability. By leveraging EPCIS, organizations can achieve unparalleled visibility into critical tracking events (CTEs) and key data elements (KDEs) across the entire supply chain.

5. Prioritize Training: Provide targeted training for your teams to drive understanding of the new traceability requirements and the importance of data quality. This helps ensure consistent implementation across your organization.

The risks of non-compliance

Failing to implement effective traceability systems by the January 20, 2026, deadline can have far-reaching consequences. Organizations may face supply chain delays, costly recalls, and other potential setbacks. Additionally, the reputational damage from being perceived as a weak link in the supply chain can have long-term impacts.

Moreover, without standardized, high-quality data, responding to food safety incidents becomes exponentially more difficult. Inaccurate or incomplete information can delay investigations, jeopardize public health, and erode consumer trust.

Beyond requirements: The business case for traceability

While meeting FSMA Rule 204 requirements is non-negotiable per the U.S. FDA, the benefits of enhanced traceability extend far beyond regulatory compliance. Organizations that invest in interoperable traceability systems gain a competitive edge in the global marketplace. They can respond more quickly to safety incidents, build stronger relationships with partners, and drive consumer confidence in their products.

A call to action for food safety professionals

With less than one year remaining until FSMA Rule 204 takes full effect, the urgency to act is clear. Food safety professionals across the industry — from processors and manufacturers to distributors and retailers — must prioritize the implementation of interoperable, high-quality traceability systems.

By embracing universal standards and focusing on data quality, organizations can navigate the path to compliance while building a stronger, more transparent global food system.

About the Author
Liz Sertl is Senior Director, Supply Chain Visibility, at GS1 US, the not-for-profit information standards organization, and has more than 20 years of experience in the CPG industry. Working closely with supply chain partners, Sertl facilitates collaboration best practices and guidelines that help companies improve product traceability and supply chain visibility through the adoption of GS1 Standards.