What Is the Shipping CTE?
The Shipping CTE is the Critical Tracking Event triggered when a business arranges for Food Traceability List (FTL) food to be transported from one location to another. It requires recording 8 Key Data Elements and passing 7 of those forward to the recipient (Source: 21 CFR 1.1340).
The Shipping CTE applies to distributors, packing houses, processors, and any other entity that ships FTL food through the supply chain.
What are the 8 required Key Data Elements?
| # | Key Data Element | Example | |---|-----------------|---------| | 1 | Traceability Lot Code (TLC) | "LOT-2028-0315-A" | | 2 | Quantity and unit of measure | "6 cases" | | 3 | Product description | "Romaine hearts, 3-pack, 12oz" | | 4 | Immediate subsequent recipient location | Restaurant name, address, phone number | | 5 | Shipping location description | Warehouse name and address | | 6 | Date shipped | "2028-03-16" | | 7 | TLC source location or TLC source reference | Packing facility name or GS1 GLN | | 8 | Reference document type and number | "Bill of Lading #B-789" |
The shipper uses the existing TLC -- they do not create a new one. TLCs are only assigned at initial packing, first land-based receiving, or transformation.
What information must be passed forward to the recipient?
Shippers must provide items 1 through 7 to the immediate subsequent recipient (not a transporter) in electronic, paper, or other written form. This means every delivery of FTL food must include:
- The TLC
- Quantity
- Product description
- Recipient location
- Shipping location
- Ship date
- TLC source
The reference document (item 8) is retained by the shipper but does not need to be passed forward.
When does the Shipping CTE NOT apply?
The Shipping CTE has three important exclusions:
- Before initial packing: Shipments of raw agricultural commodities (not from a fishing vessel) that have not yet been packed for the first time are not tracked as Shipping CTEs
- Direct-to-consumer sales: Selling food directly to consumers (e.g., farmers market sales, restaurant takeout) does not trigger a Shipping CTE
- Surplus food donations: Donating surplus food is excluded from Shipping CTE requirements
Who typically performs the Shipping CTE?
| Business Type | Performs Shipping CTE? | |--------------|------------------------| | Food distributors | Yes -- high volume, every outbound FTL shipment | | Packing houses | Yes -- shipping packed produce to distributors or retailers | | Food processors | Yes -- shipping transformed products downstream | | Farms (post-packing) | Yes -- if shipping packed RACs | | Seafood first receivers | Yes -- shipping received seafood to next handler | | Restaurant commissaries | Yes -- shipping to satellite locations | | Restaurants (direct service) | No -- selling directly to consumers | | Transport carriers | No -- carriers do not perform CTEs |
Transport carriers are not responsible for Shipping CTE documentation. The entity that arranges the shipment is responsible, not the entity that physically moves it.
How does the Shipping CTE connect to the Receiving CTE?
The Shipping CTE and Receiving CTE are mirror events. The shipper's outbound record corresponds to the receiver's inbound record. The 7 data elements passed forward by the shipper become the basis for the receiver's Receiving CTE documentation.
SHIPPER RECEIVER
Records 8 KDEs --> Records 8 KDEs
Passes 7 forward --> Uses shipper's data as input
Retains reference doc Adds own reference doc
If the data the shipper passes forward is incomplete or missing (for example, no TLC on the invoice), the receiver must still record what is available and note any gaps.
How long must Shipping CTE records be kept?
All Shipping CTE records must be retained for 2 years (24 months) from the date created (Source: 21 CFR 1.1455).
For high-volume distributors handling thousands of FTL shipments daily, the combination of 2-year retention and the 24-hour FDA response requirement effectively mandates electronic record-keeping systems.