How Growers and Packer-Shippers Can Collect KDEs and Comply with FSMA Rule 204
By iFoodDS Team
October 17, 2022
Note: This content has been updated to reflect the final version of FSMA Rule 204.
FSMA Rule 204 was finalized in November 2022, and it will enforce a new set of traceability regulations for much of the food industry. Notable changes to the final Rule include new Critical Tracking Events (CTEs) that better reflect the typical growing and harvesting workflows. This article will briefly define these different Critical Tracking Events (CTEs), the Key Data Elements (KDEs) associated with them, and ideas for efficiently capturing that information.
FSMA Rule 204 Requirements for Farms
Farms are subject to FSMA Rule 204 if they handle any of the foods on the Food Traceability List (FTL). In addition to keeping and sharing all relevant KDEs, farms must:
- Keep a traceability plan – learn more about creating a traceability plan here.
- Maintain a farm map showing the location and name of each field in which foods on the Food Traceability List are grown, including geographic coordinates and any information needed to identify the location of each field.
If you only grow foods on the FTL and do not harvest, cool, or pack them, you will not have to record any KDEs. However, you will still need to maintain a traceability plan and farm map. Farms don’t need to share this map with anyone in the supply chain but must make it available to the FDA during an investigation.
Note that there are exemptions for certain types of farms. Use the FDA’s free online tool to see if you’re exempt.
Harvesting, Cooling, and Initial Packing Critical Tracking Events
While the proposed Rule only contained a “growing” CTE, the final Rule has eliminated growing and instead focuses on harvesting, cooling, and initial packing.
Harvesting
The FDA defines harvesting as “activities that are traditionally performed on farms for the purpose of removing raw agriculture commodities (RACs) from the place they are grown or raised and preparing them for use as food.” In addition to capturing their Key Data Elements, harvesters must share these KDEs, their business name, and their phone number with the initial packer.
Harvesting KDEs
- Location description for the immediate subsequent recipient (other than a transporter) of the food
- Commodity and, if applicable, variety of the food
- Quantity and unit of measure of the food
- Location description for the farm where the food was harvested
- For produce:
- Name of the field or other growing area from which the food was harvested (must correspond to the name used by the grower), or
- Other information identifying the harvest location at least as precisely as field or growing area name
- For aquacultured food:
- Name of the container (e.g., pond, pool, tank, cage) from which the food was harvested (must correspond to the container name used by the aquaculture farmer), or
- Other information identifying the harvest location at least as precisely as the container name
- Date of harvesting
- Reference document type and reference document number
Cooling (Before Initial Packing)
According to the FDA, “Cooling means active temperature reduction of a raw agricultural commodity (RAC) using hydrocooling, icing (except icing of seafood), forced air cooling, vacuum cooling, or a similar process.” Coolers need to capture their KDEs and also share them with the initial packer.
Cooling KDEs
- Location description for the immediate subsequent recipient (other than a transporter) of the food
- Commodity and, if applicable, variety of the food
- Quantity and unit of measure of the food
- Location description for where you cooled the food
- Date of cooling
- Location description for the farm where the food was harvested
- Reference document type and reference document number
Initial Packing
The FDA states that “Initial Packing means packing a raw agricultural commodity (RAC), other than a food obtained from a fishing vessel, for the first time.” Unlike harvesters and coolers, initial packers are required to assign a traceability lot to the food they pack.
Initial Packing KDEs
- Commodity and, if applicable, variety of the food received
- Date you received the food
- Quantity and unit of measure of the food received
- Location description for the farm where the food was harvested
- For produce:
- Name of the field or other growing area from which the food was harvested (must correspond to the name used by the grower), or
- Other information identifying the harvest location at least as precisely as field or growing area name
- For aquacultured food:
- Name of the container (e.g., pond, pool, tank, cage) from which the food was harvested (must correspond to the container name used by the aquaculture farmer), or
- Other information identifying the harvest location at least as precisely as the container name
- Business name and phone number for the harvester of the food
- Date of harvesting
- Location description for where the food was cooled (if applicable)
- Date of cooling (if applicable)
- Traceability lot code you assigned
- Product description of the packed food
- Quantity and unit of measure of the packed food
- Location description for where you initially packed the food (i.e., traceability lot
- code source), and (if applicable), the traceability lot code source reference
- Date of initial packing
- Reference document type and reference document number
Shipping Critical Tracking Event
This CTE may or may not apply to farms, but will always apply to packer-shippers whenever they send out shipments – even if they are just sending product to another location in their company.
According to the FDA, shipping means “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.” This includes “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.” However, the FDA has clarified that shipping food before initial packing, donating surplus food, and sending food directly to consumers do not fall under the shipping CTE.
Shippers must record their Key Data Elements and link them to the traceability lot for the food, as well as send them to the next recipient in the supply chain (the entity they are shipping to).
Shipping KDEs
- Traceability lot code for the food
- Quantity and unit of measure of the food
- Product description for the food
- Location description for the immediate subsequent recipient (other than a transporter) of the food
- Location description for the location from which you shipped the food
- Date you shipped the food
- Location description for the traceability lot code source or the traceability lot code source reference
- Reference document type and reference document number (maintain only)
*Note: The FDA also defines a receiving CTE with KDEs that closely align with the shipping KDEs. However, the receiving CTE does not apply to receipt of a food that occurs before the food is initially packed. Therefore, farms and packer-shippers would never be considered receivers, except in cases where packed product is shipped to a different location within the same company.
What Is the Best Way to Record KDEs?
You have multiple options for recording your Key Data Elements. The FDA doesn’t mandate a particular technology or platform, and it even states that records “must be maintained as original paper or electronic records, or true copies.” It’s possible to keep paper records of your KDEs, traceability plan, and farm map and be fully compliant with Rule 204.
However, consider these other requirements from the Rule that may make keeping paper records nearly impossible:
- “All records required under this rule, along with any information required to understand the records, must be made available to the FDA within 24 hours after a request is made (or within a reasonable time to which the FDA has agreed).”
- “Unless exempt from this requirement, an electronic sortable spreadsheet containing relevant traceability information must be provided to the FDA within 24 hours of a request (or within some reasonable time to which the FDA has agreed) when necessary to assist the FDA during an outbreak, recall, or other threat to public health.”
Technology Makes It Easier to Record and Access KDEs
While the FDA requirements don’t mandate technology, they do make it challenging to comply with Rule 204 if you don’t have a technology solution. Paper recordkeeping makes it hard to pull traceability records within 24 hours. It will also be difficult to transfer the information from paper to an electronic sortable spreadsheet in that same timeframe.
Technology makes it easier to comply with the Rule. There are generally three options for keeping traceability records electronically.
Excel Spreadsheets
Excel spreadsheets are an option that may work for some farms and packer-shippers. The Excel application is commonly used and will be familiar to many users.
The main downside to Excel sheets is the limited functionality. Using spreadsheets requires manual analysis, which makes it hard to identify larger trends. Excel sheets make it difficult to scale records since data still needs to be manually entered. They also lack many of the features that come with a dedicated traceability software solution. Lastly, they are more difficult and less secure to share.
Your ERP Software
Some ERP platforms offer traceability as an add-on or standard feature. Even if your ERP doesn’t offer traceability, you may be able to record and store all your KDEs within the platform and then export data to share it.
Traceability Software Solution
There are a variety of traceability platforms available, and features vary depending on the vendor. Some offer little beyond basic digital data capture and storage, while others provide detailed analytics to help you gain insights from your data. Larger farms and packing-shipping operations will benefit from a digital platform that is searchable and makes it easy to sort records from any commodity, location, or timeframe.
iFoodDS offers a comprehensive traceability solution that includes case and pallet level options. We make it easy to create PTI and SSCC labels and get your traceability data into an electronic format.
The Importance of Providing Shipping Data in an Electronic Format
As a shipper, you’ll be required to share your KDEs with your buyers (the “receivers” you’re shipping to). The best way to do this is in a digital format. This ensures seamless sharing and full visibility. There are multiple ways to do this:
- Export the data from your ERP system in a flat file (e.g., Excel or CSV file) and send it to your buyers through a secure file transfer service.
- Use a traceability software solution that allows you to send KDEs securely.
- Send Key Data Elements through Advance Ship Notices, if your buyers currently require an ASN. Talk to your buyers about their ASN requirements and see if they will be updated to include KDEs.
Another best practice is to include GS1-128 barcodes on your labels. This helps your buyers verify the physical products they receive from you match their electronic traceability records on every shipment.
Why Farms and Packer-Shippers Need to Record KDEs
It’s critical for farms and packer-shippers to maintain records of the required traceability information. Not only does this make it easier for the next entity in the supply chain to record their KDEs, but it also helps record key food safety data that can improve our response to foodborne illness outbreaks. The more data we have, the easier it will be to conduct root cause analysis. This will ultimately improve food safety knowledge for the entire industry so that we can make fresh food safer.
Reach out to iFoodDS for a free consultation on our traceability solution. We make it easy to record your KDEs as you create labels and ship to your buyers, and we help you keep track of your shipments with our traceback/traceforward dashboard.
This material is for informational purposes only and not for the purpose of providing legal advice. You should contact your attorney to obtain advice with respect to any particular issue or problem.
