Introduction: Understanding FSMA 204

Foodborne illness – illnesses caused by contaminated food – remains a major challenge for the food industry and public health systems. The U.S. Centers for Disease Control and Prevention (CDC) estimates that foodborne illnesses affect approximately 48 million Americans annually, resulting in 128,000 hospitalisations and 3,000 deaths.

To strengthen food safety protections, President Barack Obama signed the Food Safety Modernization Act (FSMA) into law in 2011. Michael Taylor, then FDA Deputy Commissioner for Foods and Veterinary Medicine, called FSMA “the most sweeping overhaul of our food safety system since 1906.”

In this guide we will provide a full breakdown of:

                            • The Food Safety Modernization Act (FSMA)
                            • The Importance of Food Traceability
                            • The Food Traceability Rule (Section 204(d) of FSMA)
                            • The Compliance Date
                            • Who Needs to Comply?
                            • The Food Traceability List 
                            • The New Traceability Data Requirements
FSMA 204 Food Traceability

The Food Safety Modernization Act

The Food Safety Modernization Act (FSMA), signed into law in 2011, represents the most significant reform of U.S. food safety laws in over a century. It shifts the focus from responding to foodborne illness to preventing it, introducing proactive controls across the food supply chain.

The Importance of Food Traceability

Food traceability is the ability to track a food product and its ingredients through each stage of the supply chain — from production and processing to storage and distribution, in both directions. Effective traceability requires maintaining accurate records at every key step, enabling rapid identification of a product’s source or destination.

Food traceability plays a key role in the Food Safety Modernization Act. Effective tracing of food enables faster identification and removal of affected food products, reducing the public’s potential exposure to contaminated food products. Implementing stricter food traceability protocols also creates a more transparent and secure food supply chain. 

FSMA 204 Shell Eggs

The Food Traceability Final Rule (AKA FSMA 204)

The Food Safety Modernization Act (FSMA) is a broad reform of U.S. food safety laws, signed into law in 2011. Section 204(d) of FSMA directed the U.S. Food and Drug Administration (FDA) to establish additional recordkeeping requirements for certain foods to enhance traceability throughout the supply chain. This section is formally known as the Food Traceability Final Rule and is commonly referred to in the industry as “FSMA 204”.

The FDA Food Traceability Rule sets additional food traceability recordkeeping responsibilities for businesses who manufacture, process, pack, or hold foods that are featured on the Food Traceability List. These are foods that are adjudged to be at higher risk of contamination and, thus, in greater need of tracking and tracing. The recordkeeping requirements outlined in FSMA 204 are beyond those in existing regulations. 

The overall objective of FSMA 204 is to make it easier for the FDA to identify the source of a foodborne illness outbreak and remove contaminated foods from the supply chain as fast as possible, to prevent further spread. In this way, the FDA can mitigate and contain the impact of future outbreaks. This can reduce the incidences of foodborne illnesses and save thousands of lives in the United States each year.

Compliance Date

The Food Traceability Rule is currently in effect. Businesses must comply by 20 January 2026, although the FDA has announced an intention to extend the compliance deadline by 30 months, pending final confirmation.

Who Needs to Comply?

The Food Traceability Rule applies to businesses that manufacture, process, pack, or hold foods listed on the Food Traceability List (FTL).

However, several exemptions apply:

                      • Small farms with food sales averaging less than $25,000 per year (over the previous three years).
                      • Very small food businesses (including manufacturers, processors, packers, or holders) with average sales of listed foods under $250,000 per year.
                      • Retail food establishments and restaurants if more than 50% of their food sales are direct-to-consumer.
                      • Certain farm activities where traceability requirements would duplicate existing produce safety requirements (e.g., harvesting shell eggs regulated separately under 21 CFR Part 118).
                      • Transporters who simply transport food and do not otherwise hold or transform it.
                      • Foods already subject to other FDA traceability regulations (e.g., molluscan shellfish under the National Shellfish Sanitation Program).

Businesses should carefully assess their activities and product types against the FDA’s published criteria to determine whether they qualify for an exemption.

Businesses should carefully assess their activities and product types against the FDA’s published criteria to determine whether they qualify for an exemption. A full list of exemptions can be found here and the FDA has made a easy to tool to assess whether or not you are exempt here.

FSMA 204 Food Service

What is the Food Traceability List?

The Food Traceability List is a central part of the FDA’s Food Traceability Rule (FSMA 204). As mentioned above, FSMA 204 applies to businesses who manufacture, process, pack, or hold foods on the list. Listed foods include certain soft cheeses, eggs, nut butters, fresh produce, seafood, and ready-to-eat deli salads. 

The foods selected to be on the list were decided by the FDA and the CDC. The factors considered in the risk ranking model determining whether a food is included in the list are:

                          • Frequency of outbreaks and occurrences of illnesses
                          • Severity of illness
                          • Likelihood of contamination
                          • The potential for pathogen growth, with consideration of shelf life
                          • Manufacturing process contamination probability and industry-wide intervention
                          • Consumption rate and amount consumed
                          • Cost of illness

Additional recordkeeping responsibilities apply to:

                          • Foods specifically listed on the Food Traceability List.
                          • Foods that contain listed foods as ingredients, provided that they remain in the same form (e.g. fresh) as they appear on the list. 

Additional Traceability Requirements – A Glossary of Terms

If you are subject to FSMA 204 you must track certain traceability data at key intervals along the food supply chain. Below are a few of the key features of the Food Traceability Rule, which will help you understand the core requirements. 

Critical Tracking Events (CTEs): Under FSMA 204, organizations must record key supply chain stages, including harvesting, cooling, initial packing, first land-based receipt, shipping, receiving, and transformation.

Key Data Elements (KDEs): This refers to the traceability data that an organization is required to maintain and provide to their supply chain partners. These key data elements are related to the 7 most crucial stages of the food supply chain. This data will vary depending on the supply chain activity. Examples include product description, supplier details, and location description for the immediate subsequent recipient. 

Traceability Lot: This is a specific batch or ‘lot’ of food that is grouped together for tracking purposes. As the foods were batched together they share many of the same key characteristics such as where and when they were produced, the production methods used, the ingredients used etc. Traceability lots include when a raw agricultural commodity is initially packed at a farm, when a fish product is taken in by a fishing vessel from the first land-based receiver, or when an ingredient is transformed from one food to another e.g. turning tomatoes into canned sauce.  

Traceability Lot Code: A core part of the Food Traceability Rule is the assignment of a Traceability Lot Code. This is a unique identifier that is like a serial number or social security number for food. This unique descriptor, which typically contains both letters and numbers, is used to uniquely identify and track a specific batch of food through the supply chain. The traceability lot code stays with a food product through the entire global food supply chain and links it to its initial lot, batch or source. 

Traceability Lot Source: The place where a food was assigned a traceability lot code. 

Traceability Plan: A food traceability plan outlines how a food business tracks its products throughout the food supply chain, typically one step forward (where it’s going to next on the supply chain) and one step back (where it came from). You must maintain a traceability plan that reflects your current food safety and traceability practices. Each updated plan must be retained for at least two years after it is replaced, as required by FSMA 204.

Looking to Comply With FSMA 204?

If you are part of an organization that is impacted by FSMA 204 and need help to comply, we are here to help.

We can answer any questions you may have about the Food Traceability Rule, starting with whether or not you need to comply and what you need to get ready for the July 20th 2028 compliance date.

Contact our FSMA 204 compliance specialists today to assess your traceability obligations and prepare for the upcoming regulatory deadline.

Book a consultation