FSMA Rule 204 Guide
The FDA's Food Traceability Final Rule establishes requirements for tracking foods throughout the supply chain to protect public health during foodborne illness outbreaks.
What is FSMA Rule 204?
The Food Safety Modernization Act (FSMA) Section 204(d) requires companies that manufacture, process, pack, or hold foods on the Food Traceability List (FTL) to maintain records containing Key Data Elements (KDEs) associated with specific Critical Tracking Events (CTEs).
This rule creates a more standardized approach to traceability across the food industry, enabling the FDA to rapidly identify and remove potentially contaminated food from the market.
1 Food Traceability List (FTL)
A comprehensive list of foods that require additional recordkeeping, including fresh leafy greens, melons, sprouts, soft cheeses, seafood, shell eggs, nut butters, and more. The list covers high-risk foods that are frequently associated with outbreaks.
2 Critical Tracking Events (CTEs)
Specific events in the supply chain where records must be maintained: growing, receiving, transforming (creating a new food), creating (packaging), and shipping. Each CTE requires capturing specific Key Data Elements.
3 Key Data Elements (KDEs)
Required information for each CTE including: traceability lot code, quantity and unit of measure, product description, location descriptions, date and time, and reference document numbers. This data creates an unbroken chain of custody.
4 Electronic Sortable Spreadsheet
Within 24 hours of an FDA request, companies must provide an electronic sortable spreadsheet containing all relevant traceability information. This rapid response capability is critical during foodborne illness investigations.
Compliance Timeline
Final Rule published in Federal Register
Compliance deadline — All covered entities must be fully compliant with recordkeeping requirements
Who Must Comply?
How Xpired Supports Traceability
Lot Code Tracking
Automatically capture and store traceability lot codes for all FTL items entering your inventory.
Digital Recordkeeping
Maintain all required KDEs in a centralized, searchable database with automatic backups.
Rapid Response Reports
Generate FDA-compliant electronic sortable spreadsheets within minutes, not hours.
Supply Chain Visibility
Track products from receipt through sale, maintaining complete chain of custody records.