FSMA 204 Technical Guide

CTEs and KDEs Explained

A practical guide to the 7 Critical Tracking Events and Key Data Elements your system must capture for FDA FSMA 204 compliance.

April 202612 min read

What Are CTEs and KDEs?

The FDA FSMA 204 rule requires food businesses to capture and maintain specific data at critical moments in their supply chain. The rule defines two essential components:

Critical Tracking Events (CTEs): Seven specific supply chain events where you must capture and record traceability data
Key Data Elements (KDEs): The specific fields of information required at each CTE

The 7 Critical Tracking Events

The FDA identifies seven specific points in the supply chain where traceability data must be captured. Your system must be configured to capture a specific set of Key Data Elements at each CTE.

Harvesting

For raw agricultural commodities (produce, grains, etc.), the point where the commodity is harvested from the growing environment.

Required KDEs:
• Traceability Lot Code
• Product Description
• Harvest Date & Location
• Quantity & Unit of Measure
• Grower Information

Implementation note: Capture harvest location using GPS coordinates or facility identifier. Lot code must be traceable to specific field/lot/planting date combinations.

Initial Cooling

If applicable, the first cooling step applied to produce (hydrocooling, air cooling, etc.) before further processing.

Required KDEs:
• Traceability Lot Code (from Harvesting)
• Cooling Date & Time
• Cooling Location
• Cooling Method
• Lot Code After Cooling

Implementation note: Link to harvest lot code via traceability lot code. Record facility temperature controls and cooling duration for audit readiness.

Initial Packing

The first packing operation for raw agricultural commodities or first use of a traceability lot code for all food categories.

Required KDEs:
• Traceability Lot Code
• Product Description
• Quantity & Unit of Measure
• Packing Date & Time
• Packing Location
• Packaging Information

Implementation note: This is often the first CTE for processed foods. Assign unique traceability lot code if not inherited from harvest.

Transformation

Processing that changes the identity or characteristics of food, such as cooking, mixing, drying, fermentation, or any value-added process.

Required KDEs:
• Source Traceability Lot Codes (input ingredients)
• Input Ingredient Details
• Transformation Date & Location
• Processing Method
• New Traceability Lot Code (output)
• Output Product Description & Quantity

Implementation note: Record all input ingredients with their original lot codes. Map transformation recipe/process to new lot code. Critical for backward traceability.

Shipping

The point where you transfer food to a recipient (customer, distributor, retailer). This includes both outbound shipments and inter-facility transfers.

Required KDEs:
• Traceability Lot Code
• Shipped Quantity & Unit
• Ship Date & Time
• Shipping Location (from)
• Receiving Location (to)
• Recipient Information
• Shipping Container ID (optional but recommended)

Implementation note: Capture recipient name, address, and contact info. This is critical for the 24-hour recall response requirement.

Receiving

When you receive food from your suppliers. All food received (whether from suppliers or in-house transfers) must be tracked at receipt.

Required KDEs:
• Traceability Lot Code (from supplier)
• Product Description
• Quantity Received & Unit
• Receive Date & Time
• Receiving Location
• Supplier Information
• Condition Upon Receipt (optional but recommended)

Implementation note: Match received lot codes to supplier traceability lot codes. Flag discrepancies. This is your first point of control for incoming food safety.

First Land-Based Receiving

Per §1.1335, this CTE applies only to food obtained from a fishing vessel: the first land-based receiver of seafood landed by a vessel. Non-seafood imports follow the §1.1345 Receiving CTE instead, not this one.

Required KDEs (per §1.1335):
• Traceability Lot Code (assigned at first land-based receiving)
• Species and harvest date range
• NMFS Ocean Geographic Area of harvest
• Vessel name (and unique vessel ID, if applicable)
• Date of landing
• Quantity and unit of measure
• Reference Document Type and Number

Implementation note: If you are an importer of non-seafood Food Traceability List items, your obligation is §1.1345 Receiving (subject to the §1.1305(j) restaurant/RFE exemption when selling food directly to consumers), not §1.1335.

Understanding Key Data Elements

Common KDEs across CTEs

These KDEs recur across most CTEs, though the exact set required at each event differs across §§1.1325 to 1.1350. Confirm the specific KDE list against the section that governs the event at your operation:

Traceability Lot Code: Unique identifier for the traceable food lot. Must link all CTEs in the supply chain.
Product Description: Name of food, including brand, form (fresh/processed), variety, and other identifiers.
Quantity and Unit of Measure: Amount and unit (cases, pounds, units, etc.).
Location Name/ID: Facility name and address or identifier where the event occurred.
Event Type: The CTE name (Harvesting, Packing, Receiving, etc.).
Event Date/Time: When the CTE occurred (ISO 8601 format: 2026-02-05T08:30:00Z).
Supplier/Recipient Information: Name and contact for the entity providing or receiving the food.

EPCIS 2.0 Data Format

EPCIS 2.0 can support trading-partner interoperability, and some buyers may request it. FDA records requests may require records, including an electronic sortable spreadsheet under 21 CFR 1.1455(c)(3), unless an exemption or agreed alternative applies. Here is a simplified EPCIS-style example:

EPCIS 2.0 Event Example (JSON-LD)

{
  "@context": "https://ref.gs1.org/standards/epcis",
  "type": "EPCISDocument",
  "version": "2.0",
  "events": [{
    "type": "ObjectEvent",
    "eventID": "urn:uuid:a1b2c3d4-...",
    "eventTime": "2026-02-05T08:30:00Z",
    "eventTimeZoneOffset": "-08:00",
    "action": "RECEIVE",
    "bizLocation": "urn:epc:id:sgln:00012345.00001.0",
    "readPoint": "urn:epc:id:sgln:00012345.00001.1",
    "epcList": [
      "urn:epc:id:sgtin:00012345.00001.LOT-2026-001"
    ],
    "quantityList": [{
      "epcClass": "urn:epc:class:sgtin:00012345.00001.1",
      "quantity": 500,
      "uom": "case"
    }],
    "bizTransactionList": [{
      "type": "po",
      "bizTransaction": "urn:epc:id:biz:po:supplier123"
    }],
    "extension": {
      "traceabilityLotCode": "00012345678901-LOT-2026-001",
      "productDescription": "Romaine Lettuce",
      "receivingLocation": "Distribution Center #4"
    }
  }]
}

Note: Your system should generate EPCIS-compliant events automatically from CTE capture forms. The key is ensuring all required KDEs are captured and properly formatted.

Building Your CTE/KDE System

Step 1: Map Your CTEs

Identify which of the 7 CTEs apply to your business. Most food businesses won't need all 7:

Growers: Harvesting + Cooling + Initial Packing + Shipping
Processors: Initial Packing + Transformation + Shipping
Distributors: Receiving + Shipping (+ optional Transformation if repackaging)
Importers: First Land-Based Receiving + optional downstream CTEs

Step 2: Design Data Capture Forms

Create forms for each CTE that capture required KDEs. Build validation rules (lot code format, date format, required fields, etc.). Integrate with your ERP or inventory system to auto-populate supplier/location data.

Step 3: Implement Lot Code Tracking

Design your traceability lot code format. It should be:

Unique: No two lots can have the same code
Traceable: Code must be linkable across all CTEs
Consistent: Format stays the same throughout supply chain (or mapped clearly)

Step 4: Build Backward/Forward Traceability Queries

Your system must be able to answer: "What suppliers provided ingredients in this lot?" (backward) and "What customers received this lot?" (forward). Test these queries monthly.

Step 5: Establish 24-Hour Response Protocol

Document your process for responding to FDA requests within 24 hours. You must be able to identify affected lots, notify customers, and provide traceability records rapidly.

Key Takeaways

The 7 CTEs are fixed by regulation. Your job is identifying which apply to your business and capturing KDEs at each one.
KDEs are the actual data fields (lot code, date, location, etc.). You must capture all 7 universal KDEs at every CTE.
Traceability lot code is the thread linking all CTEs. If you can't trace a lot through harvest → receiving → shipping → customer, your system is incomplete.
EPCIS 2.0 can support trading-partner interoperability; confirm buyer and retailer format requirements directly.
Your 24-hour response time depends on real-time traceability queries. Test your backward/forward traceability monthly.

Next Steps

Understanding CTEs and KDEs is foundational, but implementation is where traceability work becomes operational. Start by mapping your CTEs, then build data capture workflows that integrate with your existing systems. RegEngine helps capture and review FSMA 204 traceability data in minutes instead of months.

Ready to implement FSMA 204 traceability in your business? See how RegEngine handles CTE/KDE capture, validation, and EPCIS-oriented export workflows.

Get Your Readiness Score Read FSMA 204 Overview

Questions? Contact our team for technical guidance on CTE/KDE implementation.