Food Safety Modernization Act (FSMA) 204

FSMA Rule 204 is a critical component of the U.S. Food Safety Modernization Act. It intends to create a more transparent supply chain that ensures safer food for all Americans. Want to know how to navigate these requirements?

How Walmart’s Enhanced Food Traceability Requirements Impact Suppliers

How Walmart’s Enhanced Food Traceability Requirements Impact Suppliers

Learn how to meet the new Walmart food traceability requirements with Kezzler’s Connected Products Platform for enhanced FSMA 204 compliance.

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How to Implement the FSMA 204 Traceability Rule

How to Implement the FSMA 204 Traceability Rule

Learn how to implement the FSMA 204 Traceability Rule by identifying critical tracking events, collecting key data elements, and leveraging technology for compliance and efficiency.

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Kezzler Named as an IDC Innovator in Food Traceability Technology

Kezzler Named as an IDC Innovator in Food Traceability Technology

We are proud to announce Kezzler has been named as an IDC Innovator in the IDC Innovators: Food Traceability, 2024 report.

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Unlocking the value beyond FSMA 204  compliance

Unlocking the value beyond FSMA 204 compliance

Unlock the value of FSMA 204 compliance by enhancing traceability, improving operational efficiency, and fostering consumer trust. Explore strategies for leveraging compliance into a competitive advantage.

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From Compliance to Opportunity: FSMA 204

From Compliance to Opportunity: FSMA 204

Ensure FSMA 204 compliance with Kezzler. Learn how traceability enhances food safety and efficiency.

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food traceability list

What foods are subject to the FSMA 204 rule?

The FSMA Section 204 Food Traceability List designates the initial foods subject to enforcement. The extensive list can be found on the FDA’s website and will evolve. 

foods are subject to the FSMA 204 rule: cheeses

Cheeses

foods are subject to the FSMA 204 rule: shell eggs

Shell eggs

foods are subject to the FSMA 204 rule: nut butters

Nut butters

foods are subject to the FSMA 204 rule: leafy greens

Leafy greens

foods are subject to the FSMA 204 rule: tomatoes

Tomatoes

foods are subject to the FSMA 204 rule: tropical fruits

Tropical fruits

foods are subject to the FSMA 204 rule: finfish

Finfish

foods are subject to the FSMA 204 rule: crustaceans

Crustaceans

foods are subject to the FSMA 204 rule: mollusks

Mollusks

and more…

KDEs and CTEs

Key Data Elements (KDEs) refer to the critical information required to trace food products, such as lot numbers, dates, and supplier details. Critical Tracking Events (CTEs) are the points in the supply chain where KDEs must be captured. These are essential for creating end-to-end traceability from farm to table.

Traceability challenges

Implementing a traceability system involves overcoming complex challenges that require flexible, scalable solutions

Variety of product data across SKUs

Managing different Key Date Element (KDE) requirements for a wide range of products (often within the same company) necessitates flexible metadata systems to accommodate each SKU’s unique needs.

Data acquisition from traditionally data-poor environments

Growers face significant challenges related to costs, technical complexities, and infrastructure. FSMA 204 requires data acquisition from these growers, who are often in data-poor and digitally immature environments, making initial KDE collection difficult.

Fragmented systems and data silos

Data required by FSMA 204 is often spread across multiple systems that don’t communicate with each other – no one system has all the data needed for compliance. This necessitates a unified traceability layer to create a cohesive framework, ensuring compliance and data accessibility.

Trade network data interoperability

Achieving system interoperability is crucial as FSMA 204 mandates information sharing across trading partners, but many systems are incompatible and unable to communicate effectively.

Exponential increase in data points

Linking diverse SKUs and widespread distribution channels leads to a rapid increase in data points, necessitating robust systems to manage and link these points for accurate traceability.

24-hour data collation deadline

The information must be ready to be collated and presented electronically to the FDA upon request. Considering data fragmentation and the large volume of unique data points across many SKUs, meeting this 24-hour deadline is challenging for any organization under current systems.

Value beyond compliance

How can you create a competitive advantage with traceability?

While FSMA 204 compliance is mandatory, forward-thinking companies can leverage traceability to gain a competitive edge.

Enhanced Brand Trust

Transparent traceability can boost consumer confidence in your brand.

Improved Operational Efficiency

Real-time tracking can optimize inventory management and reduce waste.

Faster Crisis Response

Quick access to accurate data enables rapid recalls and issue resolution.

Data-Driven Insights

Comprehensive supply chain data can inform strategic business decisions.

Sustainability Claims

Traceability supports verifiable sustainability and ethical sourcing claims.

RESOURCES

Essential resources for FSMA 204 readiness

  • How to Implement the FSMA 204 Traceability Rule

    How to Implement the FSMA 204 Traceability Rule

    Learn how to implement the FSMA 204 Traceability Rule by identifying critical tracking events, collecting key data elements, and leveraging technology for compliance and efficiency.

    Read more

Next Steps

Start achieving more in food & beverage

Discover how Kezzler’s Connected Products Platform can revolutionize your product data management and compliance processes. Contact us today to schedule a demo or stay informed about the latest updates and innovations. We’re here to help you achieve greater transparency, efficiency, and value across your supply chain.

Contact us

Experience how the Kezzler traceability platform can streamline your compliance with FSMA 204 and enhance your supply chain visibility. Get in touch to see our solution in action and understand how it can be tailored to meet the needs of your food and beverage operations.

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FAQs

Have questions? We’ve got answers.

How does Kezzler’s platform help with FSMA 204 compliance?

Kezzler’s Connected Products Platform simplifies compliance with the FDA’s FSMA 204 by enabling real-time, item-level traceability across your entire supply chain.

Our platform captures Key Data Elements (KDEs) and Critical Tracking Events (CTEs) at every stage, helping your business meet the record-keeping requirements and provide traceability lot codes quickly to ensure food safety.

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What are the record-keeping requirements under FSMA 204?

Companies must keep records of KDEs and CTEs for at least two years. Records should be maintained in a format that is easily accessible and can be shared with the FDA upon request in a timely manner (typically within 24 hours in the case of a foodborne illness investigation).

What are the penalties for non-compliance with FSMA 204?

Non-compliance with FSMA 204 can lead to FDA enforcement actions, including warning letters, fines, product recalls, and potentially suspension of facility registration. These penalties underscore the importance of adhering to FSMA guidelines to maintain compliance and protect public health.

How can Kezzler’s platform improve product recall management?

Our platform enables fast, targeted recalls by tracking products at both the batch and item levels. When a recall is necessary, you can quickly identify the affected products, pinpoint their exact location in the supply chain, and remove them efficiently to minimize risks and costs.

When does FSMA 204 go into effect?

FSMA 204 has a phased compliance timeline, with larger companies expected to comply sooner than smaller businesses. The final rule was published in November 2022, and businesses typically have 2 years to comply, meaning full compliance is expected by January 2026.

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