FSMA 204: A new approach to U.S. food traceability

What is FSMA 204?

FSMA 204 is part of the FDA’s effort to improve food safety and reduce foodborne illnesses. It specifically focuses on enhancing traceability systems for high-risk foods. The rule requires businesses to keep detailed records that can quickly trace food products back through the supply chain in the event of contamination.

This regulation is a response to the growing number of foodborne illness outbreaks, which have highlighted gaps in current traceability systems. FSMA 204 aims to close these gaps by enforcing better recordkeeping and faster information sharing. For compliance, businesses must be ready to provide accurate records whenever needed.

FSMA 204 also introduces a “Food Traceability List” for high-risk foods like leafy greens, tomatoes, soft cheeses, and seafood. These foods are more likely to become contaminated and can cause serious health issues during outbreaks. Businesses handling these items need to track and record key data points from the farm to the consumer, ensuring that any contamination can be quickly traced and addressed.

Key requirements of FSMA 204

To meet FSMA 204 requirements, businesses must implement systems to capture and store essential traceability information. Here are the key points:

1. Recordkeeping
   Businesses must maintain accurate records for products on the Food Traceability List. These records should include information like the product’s origin, handling dates, and processing steps. Records should be accessible and complete to ensure a fast response during investigations.

2. Rapid response
   FSMA 204 requires businesses to provide traceability information within 24 hours during a recall or investigation. Fast response times are crucial to minimizing the impact of contaminated products on consumers.

3. Data standardization
   The regulation emphasizes the need to standardize data so that it can be easily shared with the FDA. Businesses must ensure their traceability data is compatible with FDA systems to streamline investigations and recall processes.

Critical tracking events and key data elements

FSMA 204 requires businesses to track specific critical tracking events (CTEs) and key data elements (KDEs) for high-risk foods:

• CTEs include events like harvesting, initial packing, shipping, and transformation.

• KDEs for each event include details such as lot numbers, product descriptions, dates, quantities, and locations.

Businesses must also create a traceability plan, maintain electronic records in a sortable format, and be ready to provide this data to the FDA.

Why FSMA 204 matters

The goal of FSMA 204 is to improve response times during food contamination events. By strengthening traceability, the regulation helps reduce risks to public health and minimizes the financial damage from large recalls. Complying with FSMA 204 isn’t just about avoiding penalties—it’s about helping build a safer food system.

Non-compliance can lead to costly recalls, legal issues, and damaged reputations. FSMA 204 ensures that all businesses in the supply chain are prepared to trace and remove contaminated products quickly, which contributes to a more reliable food system.

How Datahex can help

At Datahex, we understand that staying on top of FSMA 204 compliance can be challenging. Our software solutions are designed to help businesses track and record the critical information required by FSMA 204, making compliance easier and more efficient.

• Paperless Forms
  Our system helps you capture real-time data for all the necessary traceability points. By moving away from paper records, you reduce the risk of errors and streamline data collection, making it easier to comply with FSMA 204.
  
  

• MyHaccpPlan
  This tool integrates hazard analysis with traceability requirements, giving you a comprehensive approach to food safety. It helps you build a robust food safety plan that aligns with FSMA 204’s requirements.
  
  

• Supplyline
  This software connects you with your suppliers and ensures that traceability data from your entire supply chain is consistent and compliant. By improving collaboration, Supplyline makes it easier to share traceability data and meet FSMA 204 standards.

With Datahex’s tools, you can simplify your compliance process while improving operational efficiency and enhancing food safety. We’re here to help you navigate the complexities of FSMA 204 and build a safer, more transparent supply chain.