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Critical Tracking Events (CTEs) Explained

Critical Tracking Events (CTEs) Explained

Learn about the FDA's Critical Tracking Events and why automated no-code solutions are essential for capturing this critical information efficiently.

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Table of Contents

What Are Critical Tracking Events?

Critical Tracking Events (CTEs) are specific activities in the supply chain where traceability information must be captured to effectively track food products. They represent key points where food is transformed or changes hands, creating potential traceability gaps if not properly documented.

Under the FDA’s Food Traceability Rule, businesses handling foods on the Food Traceability List (FTL) must maintain records of these events and their associated Key Data Elements (KDEs).


The Five Critical Tracking Events

The FDA identifies five primary Critical Tracking Events that require documentation:

1. Growing 🌱

When a food is grown or raised before initial packing

Applies to: Farms, ranches, aquaculture operations

Examples: Harvesting leafy greens, collecting shell eggs, catching fish

2. Initial Packing πŸ“¦

When a raw agricultural commodity is first packaged

Applies to: Farms, packing houses, fishing vessels

Examples: Placing tomatoes in boxes, bagging fresh peppers, packaging shellfish

3. Processing/Manufacturing 🏭

When a food is transformed or created from one or more ingredients

Applies to: Food processors, manufacturers

Examples: Creating yogurt from milk, producing nut butter, making fresh-cut produce

4. Shipping 🚚

When a food is arranged for transport from one location to another

Applies to: All entities in the supply chain that ship food

Examples: Distributor sending products to retailer, manufacturer shipping to distributor

5. Receiving πŸ“₯

When a food is accepted at a new location after transport

Applies to: All entities in the supply chain that receive food

Examples: Retailer accepting delivery, restaurant receiving ingredients


When CTEs Occur in Your Supply Chain

Different businesses will encounter different Critical Tracking Events based on their role in the supply chain:

For Farms

  • Growing (when harvesting)
  • Initial Packing (when first packaging products)
  • Shipping (when sending products to buyers)

For Processors/Manufacturers

  • Receiving (when accepting raw materials)
  • Processing/Manufacturing (when transforming ingredients)
  • Shipping (when sending finished products)

For Distributors

  • Receiving (when accepting products)
  • Shipping (when sending products to customers)

For Retailers/Restaurants

  • Receiving (when accepting deliveries)
  • May also have Processing if preparing foods on-site

Required Information for Each CTE

Each Critical Tracking Event requires specific Key Data Elements to be recorded:

For Growing Events

  • Location description
  • Traceability lot code
  • Commodity and variety
  • Date of harvest
  • Growing area coordinates or address

For Initial Packing Events

  • Location of packing
  • Traceability lot code assignment
  • Date of packing
  • Quantity and unit of measure
  • Reference to growing information

For Processing/Manufacturing Events

  • Location of processing
  • Traceability lot code assignment
  • Date of processing
  • Description of the food
  • Quantity and unit of measure
  • References to incoming ingredients and their lot codes

For Shipping Events

  • Location shipping from
  • Location shipping to
  • Date of shipping
  • Traceability lot code(s) being shipped
  • Quantity and unit of measure
  • Reference to transporter information

For Receiving Events

  • Location receiving at
  • Location received from
  • Date of receipt
  • Traceability lot code(s) received
  • Quantity and unit of measure

Documenting CTEs Effectively

To ensure compliance with FDA requirements, follow these best practices:

1. Standardize Your Documentation

  • Create consistent templates for each CTE
  • Use the same format for dates, lot codes, and product descriptions

2. Embrace No-Code Automation Solutions

  • Implement ready-to-use traceability platforms instead of custom development
  • Use barcode or QR code scanning to eliminate manual data entry errors
  • Choose solutions with built-in FDA compliance validation

3. Avoid the Custom Coding Trap

  • Custom-coded solutions often fail to adapt to regulatory changes
  • Development delays can put compliance deadlines at risk
  • Maintenance costs for custom code typically exceed expectations

4. Automate Data Collection at CTEs

  • Deploy IoT sensors and automated scanning stations at key points
  • Integrate scale systems and production equipment with traceability software
  • Eliminate paper-based processes that introduce human error

5. Train Staff on CTE Recognition

  • Ensure employees can identify when CTEs occur
  • Provide clear procedures for using automated systems
  • Focus training on exception handling rather than routine data entry

6. Establish Record Verification Processes

  • Use automated data validation to ensure completeness
  • Implement real-time alerts for missing or inconsistent data
  • Verify that lot codes are properly maintained throughout the chain

7. Conduct Mock Traceability Exercises

  • Test your ability to connect CTEs across your operations
  • Practice tracing products forward and backward through your supply chain
  • Measure response time improvements from automation

Common Challenges with CTEs

❓ What if multiple CTEs happen at the same location?

Each CTE still requires its own documentation, even if they occur at the same facility or on the same day.

❓ Do I need to record CTEs for non-FTL foods?

The FDA only requires enhanced records for foods on the Food Traceability List, but maintaining similar records for all products is a best practice.

❓ What if I don’t have all the information from my suppliers?

The rule requires you to maintain records of the information provided to you. You should request all required KDEs from your suppliers.


Need Help Implementing CTE Documentation?

Properly documenting Critical Tracking Events is essential for FDA compliance and effective traceability. Our team can help you develop systems and procedures tailored to your specific operations.

πŸ‘‰ Contact us today for a consultation or system assessment.


Additional Resources

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