FSMA 204: Shipping CTE and KDE’s

By Todd Baggett

President, Redline Solutions 

 
The FDA Final Rule on FSMA Section 204 published November 2022 requires suppliers Foods Included on The Food Traceability List (FTL) to capture and record Critical Tracking Events  

(CTE’s). The FDA defines a “Critical Tracking Event” to mean an event in the food supply chain involving the harvesting, pre-packing cooling, initial packing, shipping and receipt of a Raw Agricultural Commodity (RAC), “…not obtained from a fishing vessel, shipping, receiving, or transformation of the food.”  Each CTE required Key Data Elements (KDE’s) which are the specific things you need to capture and record when supplying food items on the FTL. 

 

Here we explore CTE’s and KDE’s for Shipping. 

 

The FDA defines Shipping as “…an event in a food’s supply chain in which a food is arranged for transport (e.g., by truck or ship) from one location to another location. Shipping does not include the sale or shipment of a food directly to a consumer or the donation of surplus food. Shipping does include sending an intracompany shipment of food from one location at a particular street address of a firm to another location at a different street address of the firm.” 

 

The new part of the regulation is the need to track intercompany transfers between addresses. If Receiving, Cooling, and Initial Packing, and shipping all occur from one physical address there is no extra tracking event. However, if the receipt and cooling happen at one location, are then transferred to another address for storage, and shipped again to a third address for initial packing and shipping you have had three separate CTE Shipping events, before the shipment going to your customer. Shipping a RAC to a Retail Food Establishment (RTE) is a CTE and as such requires the capture and reporting of Shipping KDE’s. 

 

The Required Key Data Elements in Shipping are: 

 

(1) The traceability lot code for the food; generally accepted as the current data in the GS1-128  Barcode on the PTI Harmonized case label including: 

1. The brand owners GS1 Company Prefix 
2. The product’s assigned GTIN 
3. The Traceability Lot Code 
4. The Pack Date is optional for the FDA, but is often required by your agreement with the Retail Food Establishment (RFE) 

 

2. (2) The quantity and unit of measure -i.e. 37 cases, 200 lbs.  

 

(3) The product description - i.e. Strawberries, 8- 1lb clamshells 

 

(4) The location description for the immediate subsequent recipient (other than a transporter)- of the food- This is the name of the business, or farm, that shipped you the food 

 

(5) The location description for the location from which you shipped the food- The address or GLN of the site that shipped the food  

 

(6) The date you shipped the food  

 

(7) The location description for the traceability lot code source, or the traceability lot code source reference – The location name of the initial packer or subsequent transformer 

 

(8) The reference document type and reference document number- i.e. The bill of lading (BOL) and its number, this could also include the Packing Slip and packing slip number, the ASN reference number and ASN data 

 

FSMA 204 brings new requirements to capture and record the details of FDA defined Key Data Elements of Critical Tracking Events for items on the FTL. Capturing and reporting this data is required by the FDA starting on January 20th, 2026.  Consistently doing this manually will be extremely challenging.  The good news is with software, barcoding and mobile data collection you can meet regulatory mandates, while improving the efficiency of your operations.  

 

 

 

About Todd Baggett 

Todd is the founder and CEO of RedLine Solutions. He has served the PTI Leadership Council as Co-Chair of the Technology Work Group for over 12 years. In this role he worked to develop many of the best practices surrounding case and pallet labeling and is an active member of the Industry FSMA 204 task Force. In 2014 Todd published the book “Produce Traceability for Dummies”.