FSMA 204 Compliance
Comprehensive guides to the FDA Food Traceability Rule — compliance deadlines, requirements by industry, and what you need to do.
FSMA 204 Food Traceability Rule: The Complete Guide
Everything you need to know about FDA FSMA 204. Compliance deadline July 2028, Food Traceability List, Critical Tracking Events, and industry-specific requirements.
What Must Restaurants Do to Comply with FSMA 204?
Restaurants with annual food sales over $250,000 must comply with FSMA 204 by July 2028. The only requirement is recording 8 data points at every FTL delivery.
How Does FSMA 204 Affect Cold Chain Operations?
Cold chain operators face the Cooling CTE — the one FSMA 204 requirement where IoT temperature sensors directly automate compliance documentation.
FSMA 204 Frequently Asked Questions
Comprehensive FAQ covering FSMA 204 basics, Food Traceability List, compliance requirements, CTEs, KDEs, exemptions, penalties, and temperature monitoring.
What Is FSMA 204?
FSMA 204 is an FDA regulation requiring businesses handling high-risk foods to maintain detailed traceability records. Compliance deadline: July 20, 2028.
When Does FSMA 204 Go Into Effect?
The FSMA 204 compliance deadline is July 20, 2028. The original January 2026 deadline was extended by 30 months. The rule has not been repealed.
What Foods Are on the Food Traceability List?
The FDA Food Traceability List includes leafy greens, tomatoes, shell eggs, finfish, crustaceans, soft cheeses, melons, fresh herbs, sprouts, and more.
What Are Critical Tracking Events (CTEs)?
FSMA 204 defines 7 Critical Tracking Events: Harvesting, Cooling, Initial Packing, First Land-Based Receiving, Shipping, Receiving, and Transformation.
What Is the Cooling CTE?
The Cooling CTE requires documenting active temperature reduction before initial packing. This is where IoT temperature sensors directly support FSMA 204 compliance.
Who Must Comply with FSMA 204?
Any business with food sales exceeding $250,000 that handles FTL foods must comply. Small businesses under $250K are exempt.
What Are the FSMA 204 Exemptions?
Businesses with annual food sales under $250,000 are fully exempt. Partial exemptions exist for mid-size businesses. Waivers available for economic hardship.
What Are the Penalties for FSMA 204 Non-Compliance?
FSMA 204 enforcement includes warning letters, import alerts, injunctions, civil monetary penalties, and criminal prosecution in severe cases.
What Is the Receiving CTE?
The Receiving CTE requires recording 8 Key Data Elements for every delivery of FTL food. This is the only CTE that applies to restaurants.
What Is a Traceability Lot Code (TLC)?
A Traceability Lot Code is a unique descriptor assigned at initial packing, first land-based receiving, or transformation. TLCs follow food through the supply chain.
What Is a Traceability Plan?
Every covered entity must maintain a written traceability plan describing record-keeping procedures, FTL food identification, TLC assignment, and a designated contact.
How Does FSMA 204 Affect Food Distributors?
Food distributors must maintain Receiving and Shipping CTE records for all FTL foods. High transaction volume effectively mandates electronic record systems.
What Is the Shipping CTE?
The Shipping CTE requires recording 8 Key Data Elements for every shipment of FTL food, including Traceability Lot Codes and recipient information.
What Is the Transformation CTE?
The Transformation CTE applies when FTL food is manufactured, processed, or commingled. Input TLCs must be linked to new output TLCs.
How Does FSMA 204 Affect Produce Farms?
Produce farms bear the heaviest upstream burden with up to three CTEs: Harvesting, Cooling, and Initial Packing. Farm maps with GPS coordinates required.
How Does FSMA 204 Affect the Seafood Industry?
Seafood businesses must track the First Land-Based Receiving CTE. Fresh, frozen, and previously frozen finfish, crustaceans, and bivalves are all covered.
How Does FSMA 204 Affect Food Processors?
Food processors and manufacturers must track the Transformation CTE — linking input TLCs to output TLCs when food is manufactured, processed, or commingled.