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FSMA 204 General Summary

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According to the CDC, approximately 1 in 6 people get sick each year from foodborne diseases. To increase prevention of this public health burden, the FDA released the Final Rule for the Food Safety Modernization Act (FMSA 204) in November 2022. The rule is now in effect and will start to be enforced on January 20, 2026.

This rule requires companies across the fresh produce supply chain to track and share data with a goal to reduce investigation time from 5-6 weeks to 5-6 days.

The FDA has identified a list of foods that require additional traceability as delineated on the FTL (Food Traceability List). These include both fresh produce and non-produce items.

IFPA has created a list of PLUs (confirmed by FDA) that are on the FTL: https://www.freshproduce.com/resources/supply-chain-management/fsma-204-resources

Critical Tracking Events

The rule establishes CTEs (Critical Tracking Events) for which KDEs (Key Data Elements) must be established, maintained, and linked to a Traceability Lot Code (TLC) for any foods found on the FTL.

Key Data Elements for Each Critical Tracking Event

Traceability Lot Codes

Traceability Lot Codes are central to the rule’s operation and must be assigned at the initial packing or transformation. PTI has defined the TLC as the case GTIN and the Lot Number. The TLC Source (lot code source where the TLC is assigned) must also be included with the following details:

  • Name of Packing Facility or Ranch/Farm (field or greenhouse pack)
  • Address
  • Phone Number

This information must be exchanged between trading partners throughout the supply chain to the store or restaurant. Alternatively, the TLC Source Reference can include the following:

  • FDA Food Facility Registration Number
  • GS1 Global Location Number (GLN)
  • Web address with location description for the TLC source for a specific lot

Traceability Lots Codes (TLC) with Lot Numbers must be linked at each Critical Tracking Event (CTE). The graphic below shows the interaction between different CTEs and which KDEs are required.

Traceability Plan

As a part of the FSMA 204 rule, a Traceability Plan is required. This plan must be updated as needed to ensure that it reflects current practices. Records required under the rule must be maintained for two years from the date they were created and be made available within 24 hours of a request from FDA. This plan must include the following items:

  • A description of the procedures you use to maintain the required records, including the format and location of the records.
  • A description of the procedures you use to identify foods on the FTL that you manufacture, process, pack, or hold and how you assign Traceability Lot Codes to foods on the FTL, if applicable.
  • A description of how you assign Traceability Lot Codes.
  • A statement identifying a point of contact for questions regarding your traceability plan and records.
  • If you grow or raise a food on the FTL (other than eggs), a farm map showing the areas in which you grow or raise such foods, including the location and name of each field (or other growing area) in which you grow a food on the FTL, including geographic coordinates and any other information needed to identify the location of each field or growing is required.

Get FSMA 204 Ready with Famous Software!

Traceability has always been a cornerstone of the Famous Software platform. There are numerous key features built into Famous ERP that facilitate compliance with FSMA 204, and we are making adjustments over the next year to further enhance that compliance. Contact our support team to learn more. We are here to help you be FSMA 204 READY!

Support contact info: https://support.famoussoftware.com | 559-438-3600 | [email protected]

Glossary and Additional Resources

Food Traceability List (FTL): Identifies the foods for which additional traceability records are required. The additional recordkeeping requirements apply to the foods specifically listed on the FTL, and to foods that contain listed foods as ingredients, provided that the listed food that is used as an ingredient remains in the same form (e.g., fresh) in which it appears on the list. Link: https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list

Key Data Elements (KDE): Data elements that are required to be tracked within the supply chain. Link: https://www.fda.gov/media/163132/download

Traceability Lot Codes (TLC): A descriptor, often alphanumeric, used to identify a traceability lot within the records of the firm that assigned the traceability lot code. Link: https://www.fda.gov/food/food-safety-modernization-act-fsma/traceability-lot-code

Critical Tracking Events (CTE): Specific events that need to be tracked within the supply chain. Some examples include Harvesting, Cooling, Receiving, Packing, Transformation (Repacking), Shipping. Link: https://www.fda.gov/media/163132/download?attachment

Traceability Plan: Traceability plan with specific information including description of procedures used to maintain required records (format and location), description of procedures you use to identify foods on the FTL, description of how TLCs are assigned, statement identifying a point of contact for questions, map showing growing areas. Link: https://www.fda.gov/media/174057/download?attachment

Electronic Sortable Spreadsheet: Document containing relevant traceability information must be provided within 24 hours of a request by FDA.

FDA FSMA 204 Final Rule Website: https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods

IFPA FSMA 204 Resources: https://www.freshproduce.com/resources/supply-chain-management/fsma-204-resources/