The QA Director's Guide to FSMA Rule 204.

What is FSMA Rule 204?

FSMA Rule 204, formally titled the "Requirements for Additional Traceability Records for Certain Foods" (21 CFR Part 1, Subpart S), is a final rule issued by FDA under the authority of the FDA Food Safety Modernization Act (FSMA). It requires covered entities in the supply chain for high-risk foods to establish and maintain electronic traceability records that enable rapid, lot-level trace-back in the event of a foodborne illness outbreak or recall.

The rule took effect in January 2026. It applies to all entities that manufacture, process, pack, or hold food on the Food Traceability List — regardless of size or sales volume, with limited exceptions for farms growing produce below certain thresholds.

Food Traceability List (FTL)

The FTL identifies foods that pose a higher risk of causing serious adverse health consequences or death. Foods on the FTL include:

• Fresh and cut leafy greens (romaine, spinach, kale, arugula, and others)
• Fresh tomatoes, cucumbers, and peppers
• Shell eggs
• Nut butter and tree nut spreads
• Ready-to-eat deli salads with meat, poultry, or seafood
• Fresh herbs
• Cut melons and tropical tree fruits
• Certain fresh-cut fruits and vegetables
• Certain finfish, crustaceans, and molluscan shellfish

This is not an exhaustive list — review the full FDA Food Traceability List to determine if your products are covered.

Critical Tracking Events (CTEs)

CTEs are the specific points in the supply chain where records must be created and maintained. FSMA Rule 204 identifies five CTEs:

• Initial packing: When a food on the FTL is packed into a case, container, or immediate package. This is where the first traceability lot code is assigned.
• First land-based receiver (seafood only): For fish and seafood, the first entity to receive the food after harvest from the sea or an aquaculture facility.
• Shipping: When a covered food is shipped from any location (manufacturer, processor, distributor, etc.) to the next recipient in the supply chain.
• Receiving: When a covered food is received at any location — a manufacturer, processor, distributor, or retail food establishment.
• Transformation: When a food on the FTL is changed in any way — processed, repacked, relabeled, cut, blended — creating a new lot code from input lot codes.

Key Data Elements (KDEs)

For each CTE, specific KDEs must be captured and maintained. The required KDEs vary by CTE type, but at minimum include:

• The traceability lot code (TLC) of the food
• Quantity and unit of measure
• Product description (commodity, variety)
• Location description of the immediate subsequent recipient
• Date and time of the CTE
• Reference document type and reference document number

Records must be electronic and must be provided to FDA within 24 hours of a request, in a sortable and searchable format.

Compliance Timeline

• November 2022: Final rule published in the Federal Register
• January 2026: Compliance date — all covered entities must maintain required traceability records
• Now: FDA enforcement is active. Trace-back requests are being issued to covered entities.

FSMA 204 Compliance Checklist