The Interplay of GDST and FSMA Rule 204

Seafood businesses today are facing growing consumer demand for transparency and sustainability, buyer requirements, and regulations. The Food Safety Modernization Act (FSMA) Rule 204 mandates specific traceability requirements for high-risk foods, including seafood, sold in the U.S. market. Meanwhile, the Global Dialogue on Seafood Traceability (GDST) provides a framework for standardizing how the industry collects and shares traceability data, while promoting responsible sourcing practices across international markets. Both aim to enhance food safety, mitigate risks, and improve consumer trust.

Understanding the synergies and distinctions between GDST and FSMA Rule 204 can help businesses in the seafood industry ensure compliance with evolving regulatory standards, enhance operational efficiency, strengthen market credibility, support long-term sustainability goals, and seize opportunities in today’s competitive market. Below are the key points of comparison:

1. Scope and Focus:

• GDST: Developed through a collaborative process that engaged a wide range of stakeholders across the seafood industry, this initiative aimed to establish unified standards for seafood traceability to improve transparency, sustainability, and regulatory compliance. From the beginning, the GDST emphasized inclusive participation from diverse stakeholders, including: seafood industry representatives, NGOs, governmental and intergovernmental organizations, technology providers, and academic and subject experts.

• FSMA Rule 204: Part of the broader FSMA regulations in the United States, Rule 204 specifically addresses traceability requirements for high-risk foods, including seafood, sold in the U.S. market. (See the rule’s complete Food Traceability List (FTL) )

2. Standards and Guidelines:

• GDST: Based on GS1 standards to ensure effective seafood traceability across the supply chain. GS1 is the global standards organization that developed the Universal Barcode, Global Trade Item Number (GTIN), Global Location Number (GLN), and Serial Shipping Container Code (SSCC), which serve as a common language for identifying products and locations. The GDST incorporates these standards to establish consistency and interoperability among various stakeholders. The GDST emphasizes technology neutrality, allowing businesses to implement GS1 standards using various technologies like RFID and QR codes according to their needs.

• FSMA Rule 204: Establishes mandatory requirements for record-keeping and traceability, specifying how certain foods must be tracked and documented to facilitate rapid and effective responses to foodborne illness outbreaks and recalls.

3. Implementation and Compliance:

• GDST: Encourages adoption of its standards through voluntary industry participation and collaboration, aiming to improve overall traceability practices. A business can adopt these standards by implementing a GDST-capable solution that integrates Key Data Elements (KDEs) and ensures interoperability with other traceability systems. Wholechain is a solution that enables real-time data sharing and compliance with both GDST and regulatory requirements like FSMA Rule 204, enhancing transparency and food safety in the seafood supply chain.

• FSMA Rule 204: Mandates compliance with its traceability requirements for covered entities within the U.S. food supply chain, enforced by the FDA (Food and Drug Administration). The FSMA Rule 204 compliance deadline is January 20, 2026, by which covered entities must have traceability plans in place that meet the rule’s requirements. Enforcement will be carried out by the FDA through inspections, audits, and reviews of traceability records to ensure compliance with the enhanced recordkeeping standards. If audited, a company must provide traceability information to the FDA within 24 hours of a request.

4. Market Demand and Competitive Advantage:

• GDST: Increasingly adopted by seafood suppliers worldwide in response to growing market demands for enhanced transparency and sustainability. Retailers are requiring GDST compliance from their suppliers, recognizing the importance of robust traceability to support sustainability claims and prevent product recalls. By adhering to GDST standards, suppliers can differentiate themselves in the market, ensuring access to retail channels and bolstering consumer trust through verifiable data. This voluntary adoption also facilitates global market access, appealing to multinational companies seeking standardized traceability practices across diverse regulatory environments.

• FSMA Rule 204: Mandates compliance for businesses handling seafood in the U.S., necessitating strict traceability and recordkeeping standards to enhance food safety and regulatory compliance. Compliance with FSMA Rule 204 is not just a legal requirement but also a strategic advantage, ensuring suppliers meet rigorous U.S. market entry criteria and mitigate risks associated with foodborne illnesses and regulatory penalties. Suppliers adhering to FSMA standards can differentiate themselves by providing robust traceability data that supports recall prevention and reinforces consumer confidence in product safety, thereby safeguarding public health and maintaining market competitiveness.

Integrating Traceability Using GDST and Complying with FSMA Rule 204:

As seafood stakeholders strive to meet evolving traceability standards, integrating these requirements into supply chains can seem daunting. However, achieving compliance with the Global Dialogue on Seafood Traceability (GDST) and the Food Safety Modernization Act (FSMA) Rule 204 does not require a complete overhaul. By leveraging existing resources and making strategic, incremental changes, businesses can enhance their traceability practices without significant additional time or resource commitments. The following steps outline practical ways to integrate traceability into current systems efficiently and cost-effectively:

1. Leverage Existing Software and Tools: Many seafood businesses currently utilize warehouse management (WMS) or enterprise resource planning (ERP) systems, but it’s important to assess whether these systems offer comprehensive traceability features that align with FSMA requirements. While some modern ERP systems may include built-in traceability modules, achieving true end-to-end traceability compliant with FSMA often requires more than just internal features. Businesses need to adopt traceability systems that use data standards, allowing them to integrate with existing ERP and WMS systems, and to simplify data exchange with suppliers and buyers also using traceability systems aligned with data standards, ensuring robust traceability throughout the supply chain. Wholechain’s flexible templating system and integrations are designed to help stakeholders across the supply chain collect the right data for buyers, FSMA compliance and other needs, while reducing repetitive data entry.

2. Implement Incremental Changes: Start by integrating traceability in the most critical areas of your supply chain. Focus on high-risk points such as initial sourcing and final distribution. Once these areas are compliant, gradually extend traceability measures to other parts of your supply chain.

3. LOT ID and Traceability Technology: Implementing a Lot ID system is a straightforward and effective way to enhance traceability. Start by assigning unique Lot IDs to each batch of seafood at the point of origin, which should be maintained throughout the entire supply chain. Use barcoding or RFID technology to track these Lot IDs, ensuring that each stage of the process, from production to distribution, is documented accurately. They provide a simple yet effective way to capture and record essential data points.

4. Adopt Cloud-Based Solutions: Cloud-based traceability solutions, such as Wholechain, are built on robust data standards, facilitating swift implementation with user-friendly interfaces. These solutions enable seamless real-time data access and sharing among diverse locations and stakeholders, significantly boosting supply chain transparency.

5. Engage with Technology Partners: Work with technology providers who specialize in traceability solutions for the seafood industry. These partners can offer tailored solutions that fit your specific needs and help integrate new systems with minimal disruption to your current operations.

6. Train and Support Your Staff: Ensure that your staff is well-trained in using new traceability tools and technologies. Provide ongoing support and resources to help them adapt to the new systems. Clear communication and training can significantly reduce the time and resources required for a smooth transition.

These steps provide a framework to get started in integrating traceability into current systems and supply chains. This approach ensures alignment with GDST and FSMA Rule 204 compliance, while maintaining operational efficiency and enhancing overall supply chain transparency.

The integration of GDST and FSMA Rule 204 represents a significant step forward in the quest for transparency, safety, and sustainability in the seafood industry. By understanding and leveraging the strengths of both frameworks, seafood business owners can not only comply with current regulations but also position themselves as leaders in responsible sourcing and consumer trust. As the industry evolves, the collaboration between GDST and FSMA 204 will likely play a pivotal role in shaping the future of seafood traceability, ensuring safer, more transparent, and sustainable supply chains for generations to come.

Collaborative Potential of GDST and FSMA 204:

In the future, GDST and FSMA 204 could collaborate to establish more integrated and robust traceability guidelines for the seafood industry; aligning voluntary global standards with mandatory U.S. regulations would enhance their effectiveness synergistically. This collaboration could lead to harmonized protocols that simplify compliance for both international exporters and U.S. importers. Specifically, GDST-aligned traceability technologies enable seamless data exchange among different systems, allowing suppliers and buyers to manage a single traceability system while easily sharing relevant data for regulatory compliance, including FSMA and retailer requirements. Moreover, integrating advanced technologies like blockchain, satellite monitoring, sensors, and AI can further streamline data sharing and verification processes, ensuring swift responses to food safety issues. Joint efforts in training and capacity-building would also benefit small and medium-sized enterprises, fostering inclusivity and sustainability across the seafood supply chain.