Thursday, November 16, 2023

FSMA 204: Receiving CTE and KDE’s

By Todd Baggett                                                                                                                  11/16/23

President, Redline Solutions

The FDA Final Rule on FSMA Section 204 requires suppliers of foods included on The Food Traceability List (FTL) to capture and record Critical Tracking Events (CTEs). The FDA’s CTE are events in the food supply chain requiring the capture and recording additional traceability information. 

Each CTE requires Key Data Elements (KDEs) which are the specific data elements you need to capture and record when supplying food items on the FTL .

Here we will explore KDE’s for Receiving, as described in section 1.1345 of FSMA 204 Regulations.

The FDA does not include the receiving of a RAC prior to packing in the requirement for KDE’s. This is covered by the initial packer’s requirement to identify the farm and harvest location from which the RAC originated. It does require anyone who takes physical possession of a packed RAC on the FTL to maintain Receiving KDEs.

The Required Key Data Elements in Receiving 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:

a.      The brand owners GS1 Company Prefix

b.      The products assigned GTIN

c.       The Traceability Lot Code

d.      The Harvest or Pack Date is optional for the FDA, but is often required by your agreement with the Retail Food Establishment (RFE)


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 previous source (other than a transporter) for the food- This includes the name of the business, or farm, that shipped the food you received.


5.       The location description for the location of where the food was received- The complete address, global location number (GLN), or Federal Food Registry number of the site that received the food.


6.       The date you received 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 and accurately manually capturing and recording all required data will be extremely challenging. The good news is that with software, barcoding, and mobile data collection you can meet regulatory mandates, while simultaneously improving the efficiency of your operations.

There are some exemptions for certain produce shippers, the key exemptions include

  1. The shipper sales of produce and market value of what they manufacture, process, pack, or hold without sale during prior three years is no more than $25,000.
  2.  When the produce is sold or donated directly to the consumer by the owner.
  3.  Food that is produced and packed on the farms with

a.      Packaging that maintains the integrity of the product and prevents subsequent contamination or adulteration (like a sealed bag without vents); and

b.      The labeling that reaches the consumer includes the name, complete address with state and zip code of the farm that produced and packed the food, and business phone number. Note the FDA will waive the business phone number, as appropriate, to accommodate religious beliefs of the individual in charge of the farm.

            4. Foods that receive commercial processing that adequately reduces the presents of microorganisms of public health significance. This includes:

a.      Processes that have a kill step, provided you maintain records of the kill step(s)

b.      Foods that you receive that have already had a kill step applies.

c.       The nature of the food has been changed in a way that it is no longer on the FTL.


If you receive food from an entity with one of these exemptions you must assign a Traceability Lot Code, if one has not already been assigned as well as the items 2-8 listed as Receiving KDE’s above.

The goal of the Food Safety Modernization Act is to increase safety, the increased data collection requirements also serve to provide for more surgical recalls. This limits the financial losses down the road and makes it worth the effort and up-front expense.

Tuesday, August 22, 2023