FSMA 204: Transformation CTE’s and KDE’s

By Todd Baggett, President
Redline Solutions

The FDA Final Rule on FSMA Section 204 published in November 2022 adds the requirement to capture and record Critical Tracking Events or CTE’s. The FDA defines a “Critical Tracking Event” to mean an event in the food supply chain involving the harvesting, pre-packing cooling, and initial packing of a Raw Agricultural Commodity (RAC), “…not obtained from a fishing vessel, shipping, receiving, or transformation of the food.”

In prior blogs we looked at the overall CTE requirements and explored harvesting, cooling, and Initial packing CTE’s. Today we will explore Transformations and the associated Key Data Elements (KDE’s) for that event.

The FDA defines Transformation as “…manufacturing/processing a food or changing a food (e.g., by commingling, repacking, or relabeling) or its packaging or packing, when the output is a food on the Food Traceability List. Transformation does not include the initial packing of a food or activities preceding that event…”

For produce, Transformation means a change is made to the initial packing of a raw agricultural commodity.  Transformation includes comingling of products, the repacking of products into another container, value-add processing like mixed greens or prepackaged salads, sandwiches, or other products which contain a product on the FDA’s Food Traceability List (FTL).

Whenever a product on the FTL list is transformed, a new Traceability Lot Code must be created, and a record must be maintained that includes:

    ·          The Traceability Lot Code for the transformed food

·         The location information of the location where the transformation event occurred

·         The date the Transformation was completed

·         The products description of the transformed food

·         The quantity and unit of measure of the transformed food 

·         The reference document type and reference document number for the transformation event

·         The lot description, unit of measure and amount, as well as the traceability lot number(s) of the source foods used in the transformation event

·         Food Traceability records must be maintained for two years from the date of creation

Repacking is a common practice in the produce industry and warrants further clarification.

If a repack is done within the same facility as the initial packing, there is no comingling with any other traceability lot codes, and remains the same pack style (i.e., a 40 lb. carton of cucumbers); the repack may continue to use the traceability lot code of the initial packing.

However, if there is any comingling of lots, the product pack style is changed (i.e., it changed from cartons to bags, or the repack was performed in a different facility than the initial packing, the repacker is required to maintain transformation records. If the product is relabeled, that is considered a transformation event and requires the appropriate record keeping.

The FDA clarified that Retail Food Establishments (RFE’s) and Restaurants are not required to keep transformation records because they do not ship products, they sell or send products directly to the consumer. Transformation records are not required for donated or disposed products by Retail Food Establishments (RFE’s) and Restaurants.

In FSMA Section 204 does provide Procedures for Modified Requirements and exemptions when “…we (the FDA) determine that applications of the requirements that would otherwise apply to the food or type of entity is not necessary to protect the public health.”

The data associated with FSMA 204’s critical tracking events are what enables traceability and therefore the improvement in food safety we all desire. The number of data points is not huge compared to some other industries, but enabling their acquisition and reporting is challenging, mostly since it is a new requirement. It also may require a significant investment in both hardware and software. Nevertheless, understanding the data requirements is crucial and easiest when tackled one bite at a time.