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

FSMA 204: Shipping CTE and KDE’s

A forklift in a warehouse

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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 asan 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 products 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) 

 

  1. (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”. 

FSMA 204: Receiving CTE and KDE’s

By Todd Baggett                                                                                                                         11/1...