FSMA 204: Critical Tracking Events (CTE’s) and Key Data Elements (KDE’s) for Harvesting and Cooling

When the FDA released the Final Rule on FSMA Section 204 in November one of the biggest changes was the addition of the requirement to capture and record Critical Tracking Events or CTE’s. The FDA defines a CTE as 

    “Critical Tracking Event to mean an event in the supply chain of a food involving the
    harvesting, cooling (before initial packing), initial packing of a RAC other than a food obtained
    from a fishing vessel, … shipping, receiving, or transformation of the food.”

Each of these were defined in further detail in our previous blog post. Here we will explore the Key Data Elements (KDE’s) associated with each of the Critical Tracking Events.

Harvesting and Cooling KDE’s

If you grow  food on the FDA's Food Traceability List (FTL) you must maintain records that link the items harvested to the geo coordinates of where that food came from. In produce, this is being referred to as the field map. While the grower must maintain this information, the packer of products on the FTL list is required to maintain a refence to the harvest location field map and link that to packed products traceability lot code. This traceability lot code is commonly referred to as the pack lot. The reference to the harvest location can be a web link to the farm map, or other references such as the grower’s name and block ID that uniquely identifies where the product came from.

The packer must also keep records of the harvesting and cooling of the product on the FTL, as these records need to be available in case of a foodborne illness outbreak investigation. Specific record keeping requirements by entity include:

The Harvester:

· The name of the field, including geo coordinates from where the product was harvested

· The commodity

· The variety (if applicable)

· The quantity and unit of measure

· The date of harvest

· Reference document type and number (such as the harvest order number)

· The business name and phone number

The Cooler:

· The location where product was cooled

· The commodity

· The variety (if applicable)

· The quantity and unit of measure

· The date of cooling

· The location description from the farm that harvested the product

· Reference document type and number (such as the harvest order number)

· The business name and phone number

The Harvester does not need to provide the Farm Map directly to the Packer, if they provide a reference document or web link that does have the actual farm map and geo coordinates.