By Trustwell

In the dynamic landscape of the food supply chain, regulatory compliance is not just a legal necessity; it is a cornerstone of consumer trust and brand integrity. The Food Safety Modernization Act (FSMA) Rule 204, known as the Food Traceability Final Rule, marks a significant step forward in ensuring transparency and safety in the food industry. For businesses grappling with the complexities of FSMA 204, Trustwell emerges as a guiding force, offering unmatched expertise and solutions for the food supply chain.

FSMA 204: What Is It?

In summary, the Food Traceability Rule mandates that businesses involved in manufacturing, processing, packing, or holding foods on the Food Traceability List (FTL) maintain records with key data elements (KDEs) for specific supply chain activities, which the U.S. Food and Drug Administration (FDA) has defined as critical tracking events (CTEs). This information must be captured, stored, and maintained for 24 months, and event data must be made available to FDA within 24 hours, upon request. Additionally, lot-level shipping event data must be shared with supply chain partners.

The Traceability Rule also requires that businesses establish and maintain a traceability plan that outlines procedures for record maintenance under the new requirements, identifies FTL foods handled, and assigns traceability lot codes to FTL foods.

Key Components of Planning and Implementation

With the January 20, 2026, compliance deadline now less than two years away, it is crucial for companies and professionals in the food industry to start preparing accordingly. This includes having the necessary procedures and protocols documented, employee and supplier training programs developed, and the proper tools and software systems implemented. As businesses think about their FSMA 204 journey, it is important to consider the following elements.

Strategic Planning. The cornerstone of successful FSMA 204 implementation is comprehensive planning. This encompasses all aspects of traceability and recordkeeping. Key activities in the planning phase include:

• Responsibility Identification: Assigning accountable individuals or teams is crucial for oversight and execution of FSMA 204-related tasks.
• Standard Operating Procedures (SOPs) Development: Establishing SOPs is vital to ensure uniform practices across the handling and documenting of raw materials, processing, packaging, and storage.
• Traceability Plan Formulation: Businesses must craft a traceability plan that complies with FSMA 204, detailing recordkeeping, identification methods for FTL items, assignment of traceability lot codes (TLCs), contacts for plan inquiries, and, where applicable, farm maps for producers of listed foods.
• TLC Creation: The introduction of a unique TLC, integrating a Global Trade Item Number (GTIN) with the product lot code, is the industry’s recommendation to achieve distinct traceability within a firm’s records.
• Solution Provider Partnership: Choosing a solution provider that offers tech-enabled traceability solutions is about forming a partnership that aligns with the organization’s strategic compliance needs.

Implementation.Collaborating with solution providers to put the traceability plan into action is a key step. Key activities in the implementation phase include:

• Enhanced Training: Developing and executing a continuous training program is imperative to ensure that all supply chain participants comprehend their roles and responsibilities within the FSMA 204 framework.
• Data Capture: Companies need to ensure the capability to capture and store the required KDEs for the traceability events they manage. Additionally, companies must be able to receive traceability data from their suppliers. When it comes to shipping products, coordination with trading partners is crucial to understanding their system capabilities, enabling the seamless sharing of shipping CTEs.
• Documentation Updates: Revising related food safety plans and protocols (e.g., supplier approval programs, recall plans, training protocols, etc.) is necessary to integrate the new traceability elements.
• Compliance Testing: Conducting mock recalls and traceability exercises is essential to validate the functionality of the FSMA 204 program and readiness of the team.

Leveraging Technology for Compliance and Beyond

While software is not a requirement for the implementation of FSMA 204, adopting tech-enabled traceability solutions can streamline compliance with FSMA 204’s rigorous tracking and reporting requirements. When evaluating traceability solution providers, stakeholders should consider the following:

• End-to-End Traceability: It should provide complete traceability from the point of origin (like farms or fisheries) to the end consumers. This includes tracking the production, processing, packaging, and distribution phases. Although this is not required for FSMA 204, many companies are implementing beyond the basic requirements to meet their brand promise for a transparent supply chain.
• Data Integration and Sharing: Adopt platforms that facilitate seamless data integration and sharing across different stakeholders in the supply chain. This ensures that all parties, from suppliers and distributors to grocers and foodservice operators, are able to capture, store, and share FSMA 204-compliant traceability data, promoting transparency and accountability.
• Mobile Compatibility: Mobile compatibility allows for tracking and managing the supply chain with a native app or integration into your existing mobile tools, enhancing flexibility and responsiveness.
• Customization and Flexibility: The software should be customizable to fit the specific needs and workflows of different businesses.
• Robust Reporting and Analytics: The ability to generate comprehensive reports and analytics is vital for insights into supply chain operations, identifying trends and anomalies, and making informed decisions.
• Scalability: The software should be scalable to accommodate business growth and changes in supply chain operations.
• Mock Recalls: It should have features that allow for simulated recall exercises to test the traceability system, showing your traceability plan in action.

Leveraging such technologies can help businesses not only comply with FSMA 204, but also improve overall supply chain efficiency and food safety.

Trustwell’s Role in FSMA 204 Compliance

Trustwell, leveraging its deep-rooted knowledge and innovative tools like FoodLogiQ Traceability, offers an integrated approach to comply with FSMA 204’s new traceability recordkeeping requirements. Trustwell’s heritage in the pilots and development of FSMA 204, through to the enhanced traceability functionality in the FoodLogiQ platform, underscores its expertise in traceability and food safety compliance.

In collaboration with FDA and GS1 US, Trustwell participated in pilot programs employing the FoodLogiQ software to demonstrate the practical application of traceability standards. These programs have helped shape regulatory expectations and provided Trustwell with unique insights into the operationalization of FSMA 204 compliance measures.

Educational Resources, Tailored Consulting, Trusted Partnership

Understanding FSMA 204 is crucial for effective compliance. Trustwell offers comprehensive educational resources, including detailed analysis and guidelines on the Food Traceability Final Rule, accessible through its website. These resources demystify the requirements of FSMA 204, making it easier for businesses to align their operations with the new regulations.

“Our mission at Trustwell is to empower businesses to not just meet, but exceed FSMA 204 requirements,” states Julie McGill, Vice President of Supply Chain Strategies and Insights at Trustwell. “We provide the tools and expertise needed to build a robust traceability plan that enhances food safety and quality across the supply chain.”

In addition, Trustwell’s FSMA 204 consulting services provide personalized support. From FSMA 204 education and supply chain assessments to the implementation of traceability systems, Trustwell’s experts work closely with businesses to develop and refine strategies that meet the unique needs of each entity in the fresh food supply chain.

Ready to Take the Next Step?

For businesses eager to embrace FSMA 204 and enhance their traceability capabilities, Trustwell invites you to arrange a discovery call. This initial conversation is a step toward personalized support, ensuring that your business not only meets, but thrives under the new regulatory landscape.

To learn more about Trustwell’s FSMA 204 consulting services or to arrange a discovery call, visit Trustwell’s FSMA 204 Consulting Page.

For a deeper understanding of FSMA 204 and how Trustwell can guide your compliance journey, explore Trustwell’s FSMA 204 Resources.