New Standards for FSMA 204 Compliance

Overview of FSMA 204

The Food Safety Modernization Act (FSMA) 204 establishes enhanced traceability requirements for foods listed on the FDA’s Food Traceability List (FTL). Manufacturers handling FTL items must maintain records of Key Data Elements (KDEs) and Critical Tracking Events (CTEs) to ensure rapid response during recalls or food safety investigations.

The compliance deadline for FSMA 204 is July 20, 2028. Collecting this information now allows manufacturers to assess supplier readiness, identify potential compliance gaps, and implement necessary traceability measures ahead of enforcement.

To support industry compliance, TraceGains convened a working group that developed new Supplier-Level and Item-Level Standards, now integrated into the Supplier and Item Questionnaires.

Supplier-Level Standards

These standards improve supply chain transparency and regulatory compliance by capturing essential FSMA 204 related-data, including:

1. Facility Compliance Status – Identifies whether suppliers are fully or partially subject to FSMA 204 or qualify for exemptions.
2. Traceability Measures – Confirms traceability plans, KDE/CTE documentation, record retention (2+ years), employee training, and internal audit practices.
3. Traceability Systems – Identifies whether suppliers use internal systems, third-party software, or manual record keeping managing traceability.
4. Data Accessibility – Verifies whether sortable traceability data can be provided within 24 hours to support regulatory requests.
5. Point of Contact – Ensures a designated traceability lead for direct compliance communication.

Item-Level Standards

These standards help manufacturers gather critical traceability information for FTL items by:

1. Determining FTL Status & Exemptions – Clarifies if an item or its ingredients are fully or partially subject to FSMA 204 including any applicable exemptions.
2. Classifying by FTL Category – Ensures items are categorized correctly (e.g., soft cheeses, shell eggs, nut butters) for regulatory alignment.
3. Supplier Traceability Documentation – Confirms availability of one-step-back records from immediate suppliers.
4. KDE Communication – Establishes how traceability data will be shared with customers.

The updated Supplier and Item Questionnaires are now available within the TraceGains platform, enabling users to seamlessly collect and assess traceability data in alignment with FSMA 204 requirements.