Farms/Harvesters/
Coolers/Packers
The final published language under FSMA 204, for upstream roles like Farms, Harvesters, Coolers, and Packers has been well articulated and from a compliance perspective, pretty logical for companies to work with. This is especially true for parts of the produce industry that worked on the Produce Traceability Initiative (PTI).
Helping the Food Industry Address FSMA 204
At TagOne, we believe comprehensive supply chain traceability is a journey where each company should choose its own path to its final destination. But this path should ideally start with small, baby steps.
In our view, the FSMA 204 ruling, via its industry-wide compliance mandate, will empower impacted companies to take this first small step. The word we use is empowered because post-FSMA 204, companies will have the choice to continue pushing towards their end-to-end traceability goal and set up for future success or not.
FSMA 204 Harvesting KDEs
As per the ruling, Harvesting KDEs for Raw Agricultural Commodities (RACs) not obtained from a fishing vessel, include the following:
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Location description for the immediate subsequent recipient (other than a transporter) of the food
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Commodity and, if applicable, variety of the food
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Quantity and unit of measure of the food
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Location description for the farm where the food was harvested
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Date of harvesting
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Reference document type and reference document number
The Harvester needs to provide to the Initial Packer the following information:
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Business name
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Phone number
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Harvesting KDEs (See above - except the last line item that is reference document type and reference document number)
For aquacultured food:
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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
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Other information identifying the harvest location at least as precisely as the container name
For produce:
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Name of the field or other growing area from which the food was harvested (must correspond to the name used by the grower), OR
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Other information identifying the harvest location at least as precisely as field or growing area name
FSMA 204 Cooling KDEs
As per the ruling, the Cooling KDEs for Raw Agriculture Commodities (RAC’s) not obtained from a fishing vessel include the following:
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Location description for the immediate subsequent recipient (other than a transporter) of the food
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Commodity and, if applicable, variety of the food
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Quantity and unit of measure of the food
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Location description for where you cooled the food
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Date of cooling
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Location description for the farm where the food was harvested
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Reference document type and reference document number Provide to the Initial Packer
The Cooler needs to provide to the Initial Packer the following information:
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Cooling KDEs (except the reference document type and reference document number)
FSMA 204 Initial Packing KDEs
As per the ruling, Initial Packing KDEs of Raw Agricultural Commodities (RACs), other than a food obtained from a fishing vessel should cover the following:
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Commodity and, if applicable, variety of the food received
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Date you received the food
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Quantity and unit of measure of the food received
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Location description for the farm where the food was harvested
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Business name and phone number for the harvester of the food
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Date of harvesting
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Location description for where the food was cooled (if applicable)
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Date of cooling (if applicable)
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Traceability lot code you assigned
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Product description of the packed food
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Quantity and unit of measure of the packed food
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Location description for where you initially packed the food (i.e., traceability lot code source), and (if applicable), the traceability lot code source reference
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Date of initial packing
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Reference document type and reference document number
KDEs must be linked to the traceability lot you assign for the food that you pack
For aquacultured food:
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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
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Other information identifying the harvest location at least as precisely as the container name
For produce:
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Name of the field or other growing area from which the food was harvested (must correspond to the name used by the grower) OR
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Other information identifying the harvest location at least as precisely as the field or growing area name
How TagOne Helps Farms/Harvesters/Coolers/Packers
Address FSMA 204
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TagOne’s comprehensive first mile solution, TagOne Cultivate is set up to help you capture, store and upload relevant upstream KDE’s via multiple options:
- Desktop
- Mobile
- Tablet
- Directly from your existing systems via our open API framework (in case you are capturing data at different locations using different systems)
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In addition, TagOne will work with you to help incorporate missing KDEs (if any) to your existing business i.e., make changes to your existing processes/systems or other
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TagOne Cultivate Desktop, gives you the following 2 options to capture, store and upload the relevant first mile KDEs:
- GUI where you can directly enter the data in the system
- Macros enabled, pre-built excel sheets. Whenever you are ready to input the transaction data, all you need to do is to download the excel sheet, populate the relevant fields, and then upload in bulk to the TagOne system. All in a matter of minutes.
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TagOne Cultivate is an advanced farm traceability solution and besides the specific KDE’s outlined in FSMA 204, has the ability to capture hundreds of additional attributes that will help you run your farm operations better
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Pre-built connecters to leading industry solutions like SAP, QuickBooks, Shopify, Big commerce
TagOne FSMA 204 Compliance Packages
Basic Compliance Pack
Our Basic Compliance pack is your low-cost option to successfully address the FSMA 204 ruling as it stands today. Key features include:
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Self-setup of your company account on the TagOne traceability cloud
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Digitization and store your specific CTEs and KDEs in the TagOne cloud via pre-built excel sheets or via the TagOne mobile app
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One-click FDA reporting in a matter of seconds
Compliance+ Pack
Our Compliance+ pack will give you all the functionality of your basic pack PLUS you'll get the following features:
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Inventory Management
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Master Data Management
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Document Management
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Ability to add supporting info beyond the KDEs to each transaction (Documents/Pictures/Data)
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Traceability reports (one up/one down)
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Recalls and Returns
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Audit Logs
TagOne FSMA 204 Advisory + Roadmap Services
The TagOne team fully understands that comprehensive traceability is a journey and we will support you every step of the way.
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Our traceability process consultants will work with you to map your existing processes to the Critical Tracking Events (CTEs) outlined in the proposed rule and identify all their supporting KDEs.
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We will work with your team to identify any process gaps and work to come up with pragmatic solutions to address them.
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We will conduct onboarding sessions for your TagOne users to ensure they fully understand the workings of the system and are easily able to capture the relevant KDEs against the mapped CTEs.
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We will ensure that this information is securely stored on our AWS cloud so you can access it on an “as needed” basis.
The TagOne Value
Central Regulatory Repository
TagOne is your Single source of truth for all FDA-related traceability data and documents.
Traceability Data Digitization
TagOne will enable you to Capture, Store, and Share relevant traceability data on an “as-needed” basis.
Traceability Reports in Seconds
On a button-click, fetch the TagOne Traceability Map view or Table view report based on Item name/Lot#. This is all you will need in the case of an FDA inquiry.
Traceability Consulting
TagOne is not only your tech traceability platform of choice but our traceability experts will help you navigate this traceability journey every step of the way.