The Food Safety Modernization Act (FSMA) represents a significant shift in how food safety is managed in the United States. One of its key sections, FSMA Section 204, focuses on enhancing food traceability to address foodborne illness outbreaks more effectively. The compliance rules defined in FSMA 204—which were initially set to enter into force in January 2026—will apply from July 2028, placing new requirements on organizations that handle specific food items.
What is FSMA Section 204?
FSMA Section 204, also known as the FDA final rule on Requirements for Additional Traceability Records for Certain Foods, mandates capturing and reporting key data elements (KDEs) for specific foods. The regulation is designed to enable the FDA to identify and remove potentially contaminated food items from the market swiftly, thereby reducing the health risks associated with foodborne illnesses.
Key requirements for organizations involved in the food supply chain
The FSMA Section 204 regulation identifies seven Critical Tracking Events (CTEs) in the food supply chain. Organizations involved in these CTEs must maintain a traceability plan, capture related KDEs for each event, and enable data reporting to the FDA within 24 hours upon request. The CTEs include:
- Harvesting
- Cooling
- Initial packing
- First land-based receiver
- Shipping
- Receiving
- Transformation
For each CTE, organizations must capture specific KDEs, which vary depending on the event but often include information such as the location, date, and time of the event, the quantity and type of food involved, and the Traceability Lot Codes (TLCs) assigned to the food products.
Foods in scope of the regulation
To focus the regulatory efforts on foods that present the highest public health risks, the FDA maintains a Food Traceability List (FTL) that governs which foods are in scope for the FSMA 204 regulation. This list includes various high-risk foods such as:
- Fresh leafy greens
- Fresh-cut fruits and vegetables
- Soft cheeses
- Shell eggs
- Nut butters
- Certain seafood items
Foods that contain listed foods as ingredients are also subject to the additional recordkeeping requirements, provided the listed food remains in the same form (e.g., fresh) in which it appears on the list.
While the regulation covers a broad range of foods, it provides several exemptions that are listed in § 1.1305 of the final rule.
Steps to prepare for FSMA Section 204 compliance
While the compliance deadline was pushed out to July 2028, it is crucial to work on deployment plans already now. The extended deadline provides ample time for companies to understand the requirements and implement the necessary systems to ensure compliance. However, delays can lead to rushed implementations, increased costs, and potential non-compliance penalties.
Key steps that organizations should take as they prepare for FSMA Section 204 compliance include:
- Understand the requirements: Organizations must familiarize themselves with the FSMA Section 204 regulation, including the specific KDEs and CTEs they need to track.
- Develop a traceability plan: A comprehensive traceability plan should outline how the organization will capture, store, and report KDEs for each CTE.
- Implement technology solutions: Leveraging technology solutions that automate the capture and reporting of KDEs can streamline compliance efforts and improve overall supply chain performance.
- Train staff: Ensuring that all relevant staff members are trained on the new requirements and the organization’s traceability plan is essential for successful implementation.
- Collaborate with supply chain partners: Effective compliance requires collaboration across the supply chain. Organizations should work closely with their suppliers and customers to ensure seamless data exchange and traceability.
Benefits of enhanced food traceability
Complying with FSMA Section 204 offers several benefits beyond regulatory adherence. Implementing the required improvements in food traceability enable, for example:
- Enhanced food safety: Rapid identification and removal of contaminated products reduce the risk of foodborne illnesses.
- Efficient recalls: Targeted, precise recalls minimize the associated costs and impact on business operations.
- Operational efficiency: Enhanced traceability enables streamlined inventory management and optimized supply chain operations.
- Consumer trust: Transparency in the food supply chain enhances consumer trust and brand loyalty.
Partnering with OpenText to ensure FSMA Section 204 compliance
To efficiently meet the compliance requirements for FSMA Section 204, organizations should look to automatically capture the KDEs on all CTEs they participate in. OpenText Business Network offers a highly configurable solution for companies in the food supply chain to automate FSMA compliance while improving their overall supply chain performance.
By leveraging OpenText’s deep expertise and advanced technology portfolio, businesses can ensure seamless data exchange with supply chain partners and meet the FDA digital reporting requirements.
To learn more about FSMA Section 204 and how OpenText can help your organization, please read our InfoDoc: Food Safety Modernization Act (FSMA) – Section 204(d)
