Is your business ready for the FSMA 204 traceability tsunami?

In the ever-changing landscape of food safety and traceability, another shift is on the horizon. The US Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA) Section 204 is set to revolutionize how the food industry tracks and traces products. This isn’t just another regulation – it's a game-changer that will reshape the entire supply chain.

It is worth noting that if your small business is under the threshold for compliance, you may be indirectly affected if your larger customers require traceability information to maintain their own compliance.

Key requirements to meet FSMA 204

The rule centers around four main components:

1. Food Traceability List (FTL): a comprehensive list of foods subject to the new requirements. FTL in detail
2. Key Data Elements (KDEs) and Critical Tracking Events (CTEs): specific data points that must be recorded at crucial stages of the supply chain. CTEs & KDEs in detail
3. 24-hour documentation requirement: Businesses must be able to provide required records within 24 hours of an FDA request
4. Assignment, recording and sharing of traceability lot codes (TLCs) for FTL foods

The FDA is implementing these changes to enhance food safety, expedite the tracing of contaminated products and minimize the impact of foodborne illness outbreaks.

Global perspective: FSMA 204 vs EU and other traceability requirements

The breadth of FSMA 204 underscores its potential to influence future regulations and industry practices globally.  Other countries may follow suit, creating a ripple effect across the international food industry.

For businesses already operating globally, compliance with FSMA 204 may position you to meet or exceed many international traceability requirements. To ensure any changes you make to meet compliance it is important to understand the nuances of each market you operate in.

GS1 standards and barcodes: the universal language of traceability

Enter GS1 Standards – the global language of business. These standards play a crucial role in supply chain management, providing a consistent system for identifying, capturing, and sharing supply chain data.

GS1 Standards align seamlessly with FSMA 204 requirements, facilitating the recording of KDEs through standardized barcodes such as GS1-128 and DataBar, the two most relevant for the food industry.

Using standardized barcodes offers numerous benefits:

• Improved accuracy in data capture
• Enhanced interoperability across the supply chain
• Easier compliance with FSMA 204 and other regulations

By adopting GS1 Standards, businesses contribute to a globally consistent traceability system, paving the way for smoother international trade and improved food safety worldwide.

Benefits of digital systems beyond compliance

While the idea of shifting current systems for record keeping and tracking to a more digital system may seem daunting, the shift brings substantial benefits to your business outside of compliance requirements.

Comparison of manual approach to digital approach of record keeping

From ocean to plate: why seafood processors are feeling the heat

The seafood industry faces unique challenges in FSMA 204 compliance, with nearly all seafood products refrigerated, fresh, frozen or previously frozen, on the FDA FTL, including:

• Finfish
• Smoked finfish
• Crustaceans
• Molluscan shellfish, bivalves

The interlinking, international nature of seafood supply chains combines with its perishable nature to add another level of complexity to meeting FSMA 204 compliance.

Five or more stops in a seafood supply chain is not uncommon, with inventory churn needing to be measured in minutes and hours rather than days or weeks. Seamlessly passing information between players requires shared standards and protocols.  However, even with these challenges, forward-thinking businesses can leverage the introduction of FSMA 204 compliance for their competitive advantage.

Interoperable seafood traceability systems: introducing CATCH

Building on EU General Food Law traceability requirements, as of January 10, 2024, with full compliance required by January 10, 2026, fisheries that import to the EU are required to upload detailed catch certification and related documents onto the IUU regulatory IT system CATCH; including:

• Fishing vessel identity
• Species caught
• Catch dates and areas
• Quantities landed

The use of CATCH is mandatory. It streamlines the certification process with a fully digitalized workflow, thus facilitating the exchange of data, information and documents between trading parties and authorities. The aim of the improved, digital system is to prevent, deter and eliminate illegal, unreported and unregulated fishing.

Case study

Observing the rapid development of technologies over the last few years in the fish processing industry, Icelandic whitefish producer Brim digitalized their product processing in 2022. Brim products are now traceable from ocean to shelf simplifying tracking and ensuring greater food safety. Real-time monitoring and order management has maximized raw material use and made production scheduling according to market demand much easier. “With Marel Software, we have more information about the product than ever before and a clear overview of the status of every order,” says Gísli Kristjánsson, Director of Production at Brim.

The clock is ticking and waiting could cost you 

The challenges in meeting these new regulations will be significant for a number of reasons:

• Many businesses still rely on paper-based systems
• Digital transformation requires careful change management
• Seafood supply chains are often long and complex
• Hiring or training employees in necessary skills will cost time and money

The biggest hurdle is often not the technology but managing the internal cultural shift towards digital processing.

Partnering for success: your FSMA 204 compliance journey and beyond

Navigating the complexities of FSMA 204 doesn’t have to be a solo journey. By partnering with the right software provider, you’re not just buying a solution, you’re investing in a long-term relationship that will guide you through compliance and propel your business into a digital future with confidence.

We develop solutions tailored to address the unique challenges and objectives of businesses in the industry:

1. Expert consultation to create the right roadmap for your specific business needs
2. Software for seamless compliance: built-in features address FSMA 204 requirements, ensuring you’re always ahead of regulatory changes
3. Growth-ready: as your business evolves, our scalable solutions grow with you, adapting to new industry challenges and opportunities
4. Future-proofed: regular updates keep you aligned with emerging industry standards and technological advancements
5. Operational excellence: beyond compliance, gain real-time insights to optimize your operations and boost profitability