Marketing Communications Manager
May 23, 2022
min read

FDA reworks FSMA section 204 to enhance traceability of potentially contaminated food

The Food and Drug Administration (FDA) is currently developing additional recordkeeping requirements for businesses along the supply chain to enhance the traceability of potentially contaminated food products.

These practices shall intensify the tracking and tracing of certain foods to ensure fast and effective traceability processes in case of potential recalls. The FDA aims to foster the rapid and effective identification of the contaminated foods’ recipients to mitigate or prevent foodborne illness outbreaks or serious adverse health consequences for consumers.

The updated rules of section 204 of the Food Safety Modernization Act (FSMA) are expected to be published by 7 November this year (1). Once in effect, the affected food businesses, such as manufacturers, processors, packers and storers, will have time until 2025 to implement the new tracking requirements for critical tracking events involving food products such as dairy, seafood or ready-to-eat products.

Additional Traceability Records for Foods listed on the FTL

The new traceability rules will become mandatory for all foods and ingredients that are listed on the Food Traceability List (FTL, see figure 1). However, the FDA encourages an industry-wide voluntary adoption of these practices.

The FDA developed a risk-ranking model for food tracing to determine which foods to include on the Food Traceability List. In total, 200 commodities in 47 categories, as well as100 hazards, were identified as food hazard pairs for the risk-ranking model. Hazards were classified into three categories: microbial hazards, chemical hazards and undeclared allergens that focus on the eight major food allergens.

Based on that risk-ranking model, the following food products and ingredients were included in this Food Traceability List:

FDA Food Traceability List

Figure 1: Summary of the FDA Food Traceability List (FTL)

The new rule features two main elements:

1.     Critical tracking events

2.     Traceability Program Records

1.    Critical Tracking Events

Food manufacturers, processors, packers and storers along the food supply chain will be required to create and maintain tracking records containing various additional Key Data Elements (KDEs) in case of so-called Critical Tracking Events (CTEs).  

These CTEs can happen at any stage along the supply chain related to growing, receiving, transforming, creating, and shipping those foods on the Food Traceability List. Those required key data points would vary depending on the critical tracking event. However, all records must contain and link the traceability lot code of the food to the relevant KDEs. For details on those KDE see the FDA website.

2.    Traceability Program Records

In addition to the required KDE records, all organizations and individuals who manufacture, process, pack or hold foods that are on the food traceability list need to maintain records of their traceability program. These records need to include information on:

-         Relevant reference records

-         Shipped foods that are on the FTL

-         How traceability lot codes are assigned

-         Additional information needed to understand the provided data


Increased efficiencies with digital traceability solutions offer  

Food manufacturers will have to establish additional record-keeping for those identified high-risk foods in a central and easily accessible location to rapidly and effectively identify potential recipients of potentially contaminated food products.

While the new rule for food traceability won’t require food companies to maintain electronic records, the FDA demands an answer from the involved businesses within24 hours in case of a food recall. This might pose a challenge for those food businesses who need to collate various paper forms in such a case. The FDA, therefore, encourages businesses to implement appropriate technologies that enhance the tracking and tracing of food.

Digitizing their traceability records gives businesses a good opportunity to increase efficiencies and also streamline their internal traceability exercises and audit preparations. If you want to learn more about digitizing your traceability records, contact us today.


1) Bhattacharyya, S.(2022). FDA Official Says New Rule Could Boost Blockchain-Based Food Tracking.

2) US Food and Drug Administration.(2021). Food Traceability List.

3) US Food and Drug Administration. (2020). Which Key Data Elements Would Apply to Me?

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