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FSMA 204

The Food Traceability Rule

Enhancing Food Safety Throughout the Supply Chain

FSMA 204, also known as the Food Traceability Rule, is a key part of the Food Safety Modernization Act (FSMA), which is transforming the United States food safety system by shifting the focus of food safety from reactive measures to a more preventative approach.

‘FSMA 204’ is informal shorthand for the FDA’s 2022 final rule, Requirements for Additional Traceability Records for Certain Foods, issued under Section 204(d) of the Food Safety Modernization Act (FSMA). FSMA 204 sets additional food traceability recordkeeping responsibilities for businesses who manufacture, process, pack, or hold foods on the Food Traceability List. 

The Food Traceability Rule is being implemented to increase safety and transparency in the food supply chain and protect against foodborne illness.

Each year, approximately 1-in-6 people in the United States suffer from a foodborne illness, with 128,000 requiring hospitalisation and 3,000 deaths. This is according to research by the U.S. Centers for Disease (CDC).

The original date for compliance was Tuesday, January 20, 2026. However, in March of 2025, the FDA announced a 30 month extension, pushing the new deadline to July 20th, 2028.

Ultimate Guide to FSMA 204

Who Must Comply?
The Food Traceability List

The Food Traceability List is a designated list of ‘high-risk’ foods for which additional food traceability records are required. These additional records are necessary not only for foods on the list but those that contain listed foods as ingredients, provided they are in the same form.

The FDA listed a total of 19 food types, which we have further divided into 6 broad categories. 

See Full List
Cheeses

Excluding hard cheeses, frozen or previously frozen, shelf stable, or those that are aseptically processed and packaged.

Nut Butters

Including, but not limited to, almond, cashew, chestnut, coconut, hazelnut, peanut, pistachio, and walnut butters.

Shell Eggs

‘Shell egg’ means the egg of the domesticated chicken.

Fresh Produce

This includes named fresh and fresh cut fruit, vegetables, leafy greens, herbs, and sprouts. 

Fish & Seafood

This includes finfish, smoked finfish, crustaceans, and molluscan shellfish (fresh, frozen, and previously frozen).

Ready-To-Eat Deli Salads

Includes all types of refrigerated ready-to-eat deli salads, including previously frozen salads. (excludes Meat salads)

Core Requirements of FSMA 204

Persons subject to the rule must carry out the following:

  • Maintain a record of Critical Tracking Events (CTEs).

  • Record Key Data Elements (KDEs) related to these events.

  • Assign a Traceability Lot Code (TLC) to designated foods.

  • Develop a Traceability Plan.

  • Maintain records for 24 months, and provide information to FDA within 24 hours when an outbreak occurs.

How to comply

Critical Tracking Events (CTEs)

FSMA 204 requires organizations to keep a record of a number of crucial stages along the food supply chain. These are known as Critical Tracking Events (CTEs) and include 7 key stages. 

  1. Harvesting: Removing foods from the place they were grown.

  2. Cooling: Temperature reduction of a raw agricultural commodity.

  3. Initial Packing: Packaging a commodity for the first time.

  4. First Land-Based Receiver (from a shipping vessel).

  5. Shipping: From one part of the supply chain to another. 

  6. Receiving: Someone receiving a product at another location. 

  7. Transformation: Manufacturing/processing or changing a food.

Full FDA Breakdown

Key Data Elements (KDEs)

Key Data Elements (KDEs) refers to the traceability data that an organization is required to maintain and provide to their supply chain partners related to each critical tracking event. This data will vary depending on the supply chain activity. 

A core part of the Food Traceability Rule is the assignment of a Traceability Lot Code. This is a unique identifier that follows a food product through the global supply chain and links it to its initial lot, batch or source. This allows the FDA to quickly identify the source of the food if an outbreak occurs. 

FAQs and resources

Developing a Traceability Plan

If you are subject to the requirements of the final rule, you must establish and maintain a traceability plan.

This includes details such as how you are maintaining a record of the required data; how you are identifying foods on the Food Traceability List; how you assign Traceability Lot Codes; a point of of contact; and a farm map if you grow or raise food yourself. 

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This is the most sweeping overhaul of our food safety system since 1906” 

Michael Taylor
Deputy Commissioner for Foods and Veterinary Medicine at the FDA

Need help complying with FSMA 204?
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