Understanding FSMA 204: The Food Safety Modernization Act Rule for Food Traceability - An Introductory Guide
The Food Safety Modernization Act (FSMA) was signed into law in 2011 and enables the Food and Drug Administration (FDA) to better protect public health by strengthening the food safety system from farm (and the first land-based receiver from a fishing vessel) to retailer or restaurant. FSMA Section 204 defines the Food Traceability Final Rule passed on November 21, 2022 and establishes additional recordkeeping requirements for domestic or foreign entities that manufacture, process, pack, or hold foods on the Food Traceability List (FTL) destined for sale to U.S. consumers.
The purpose of FSMA 204 is to reduce the incidence of foodborne diseases in the U.S. by instituting a rigorous traceability framework that enables rapid detection and response to outbreaks of foodborne disease to help prevent them from happening and limit their effects on the population. This goal is to be accomplished with enhanced tracking, monitoring, and record keeping to limit the public’s exposure to unsafe food.
This article provides an overview of FSMA Section 204 to the affected entities involved in the food supply chain. Every entity that participates in the harvesting, packing, and transportation of foods covered by Section 204 needs to comply with the regulations. We will identify how FSMA Section 204 impacts companies in the food supply chain and what they need to do to meet its requirements.
While the methods used to implement FSMA are generally not prescribed by the FDA it is clear that use of automated identification systems (Auto ID) will be necessary in order to not incur huge increases in labor costs. A side effect of compliance with FSMA 204 is likely to be the deployment of a new generation of visibility platforms including those that use smart tags. While the bulk of this article will focus on what the new rule requires independent of any technologies used, we will explain how the latest generation of ambient Internet of Things (IoT) technology is proving to be an effective approach to implementing FSMA 204 record keeping as well as establishing an infrastructure that can be used for other applications such as on-shelf availability optimization, improving shelf life, waste reduction, and compliance with sustainability regulations.
Overview of FSMA 204
The main objective of FSMA 204 is to protect the food supply chain and ultimately food safety by increasing transparency via additional traceability records for certain foods on the FTL. Organizations that must comply with FSMA 204 include commercial farms, packing operations, and food processing facilities. Exemptions to the rule are available for small farms and companies. FSMA 204 goes into effect on January 20, 2026.
FSMA 204 applies to all food facilities except meat, poultry, and certain egg producers, which are regulated by the U.S. Department of Agriculture, and other items that normally undergo a killstep before human consumption. A key element of FSMA 204 is the creation of the Food Traceability List (FTL) that defines foods that require additional recordkeeping. Items on the FTL include:
Many fresh fruits and vegetables;
A variety of soft cheeses;
Shell eggs;
Nut butter;
Some categories of seafood;
Refrigerated and ready-to-eat deli salads.
Recordkeeping and Training
Documentation and training are critical components of FSMA 204. Documentation involves several complementary elements that facilitate tracking a commodity throughout the food supply chain.
This is accomplished by linking traceability lot codes (TLCs) that link foods to key data elements (KDEs) that are maintained for critical tracking events (CTEs) in the food handling process.
Traceability lots are batches of food subject to FSMA 204 that have been originally packaged, received by the first land-based receiver, or transformed.
Traceability lot codes are descriptors used to identify a traceability lot. The traceability lot code source is the location where a raw agricultural commodity (RAC) was assigned a traceability lot code.
TLCs are essential components of Rule 204. A TLC is typically an alphanumeric descriptor that identifies a traceability lot. Traceability lot codes are assigned to batches of food that have been initially packaged, received from a fishing vessel, or transformed. The TLC source is the place where the TLC was assigned.
The encoding of the TLC is not prescribed by the FDA so long as the number is unique. The most frequent format used is the GS1 SGTIN or Serial Global Trade Identification Number. Another viable format is the UUID (Universally Unique Identifier) defined by the Internet Engineering Task Force (IETF).
As food moves through the supply chain, organizations are required to collect Key Data Elements that allow the progress of food along the supply chain to be tracked and associated with a Traceability Lot Code. Each stage where this data collection is required is called a Critical Tracking Event.
The Critical Tracking Events are:
Harvesting encompasses the activity traditionally performed on farms by removing RACs and preparing them for use as food.
Cooling refers to the active temperature reduction of a RAC.
Initial packaging of RACs refers to the first time a RAC is packaged.
First land-based receiving speaks to the initial receiver of food from a fishing vessel.
Transformation is an event in the food supply chain that processes food or changes its packaging.
Shipping is any event in the food supply chain where products are transported from one physical location to another one.
Receiving refers to events in the food supply chain where commodities are received by an entity other than a consumer.
KDEs such as the traceability lot code, the number of goods shipped or received, where it came from, where it is being shipped to, data received, and where a product was transformed are collected at each CTE.
Traceability plans
Organizations in the food supply chain need to develop a traceability plan that includes the following elements:
A description of how records are maintained including their format and location;
A description of the procedures used to identify foods on the FTL;
How traceability lot codes are assigned;
Contact information for questions regarding the plan and record keeping.
Traceability plans must be updated when necessary and old plans need to be retained for two years. All records required by Rule 204 need to be maintained for two years after creation. The records can be stored offsite but must be made available within 24 hours at the request of the FDA. Records need to be provided in an electronic, sortable spreadsheet format when requested by the FDA.
Organizations must create a traceability plan that documents the procedures used to maintain required records. This includes describing the procedure used to identify foods on the FTL and how traceability lot codes are assigned. The plan also needs to provide contact information for answering questions about the plan and records.
In summary, each participant in the supply chain will need to be prepared to provide the FDA, upon 24 hours notice, with a spreadsheet that connects the food items they deliver to the next party in the chain. This connection is achieved using a traceability lot number, which ultimately links every case of food in a retailer back to the field from which it was harvested.
Triggers for sharing
The sharing of data under FSMA Section 204 can be triggered by several factors, such as:
Foodborne illness outbreak: If there is an outbreak of foodborne illness linked to a specific product, the FDA may require information from all stakeholders involved in the supply chain to trace the source of contamination and prevent further distribution of the contaminated product.
Recall: In the event of a recall, the FDA may require companies to provide information about the affected products, including the source, distribution, and location of the products, to ensure a swift and effective recall.
Inspection and Compliance: The FDA may request data from food facilities during routine inspections or as part of an investigation to verify compliance with FSMA regulations and identify potential risks in the food supply chain.
Suspected adulteration or misbranding: If there is a reasonable belief that a food product may be adulterated or misbranded, the FDA may require information from companies to determine the source of the issue and take necessary action.
Information requests: The FDA may require food facilities to provide specific information, such as production, distribution, and location data, to aid in the tracking and tracing of food products and enhance the overall food safety system.
Companies involved in the food supply chain must provide employee training that stresses food safety and minimizes risks to the food supply. Employees are the first line of defense against food contamination. Promoting a culture of safe food throughout the organization is highly recommended and provides a foundation on which FSMA compliance can be built.
How Wiliot can Help with FSMA 204 Compliance
Wiliot is the leader in the latest generation of what is called ambient IoT or Internet of Things technology. It uses smart tags and cloud services that harness the latest advances in artificial intelligence to bring automation to the everyday things that surround us, including food, medicine and clothing. This automation reduces the need for a major increase in labor costs for FSMA compliance and ensures higher degrees of compliance than legacy technologies such as barcodes and RFID tags that frequently require use of hand held scanners and expensive infrastructure.
Wiliot’s smart tags, known as IoT Pixels, in combination with the company’s cloud platform, enable companies to comply with FSMA 204. The IoT Pixels are flexible, battery-free, devices (the size of a postage stamp) that can communicate location and temperature information about a food supply chain component directly to the cloud platform. The data they make available can be used to address multiple aspects of FSMA 204 compliance. The following examples illustrate how IoT Pixels can be used to address a wide range of issues related to food safety and FSMA compliance.
Record keeping and Documentation - Documenting compliance initiatives and keeping reliable records related to food safety and the supply chain are essential components of FSMA, specifically Section 204 and the Food Traceability Final Rule. IoT Pixels facilitate these activities by:
Automating the collection of data at each stage of food production and handling;
Reducing staff overhead and manual errors associated with record keeping;
Enabling effortless access to pertinent data to provide evidence during inspections or audits.
Inventory Management - Inventory management is crucial to maintaining food safety. IoT Pixels can be used to:
Track the location of products within a facility;
Enable traceability and efficient recalls when necessary;
Reduce the risk of cross-contamination when issues are identified.
Supply Chain Visibility - Visibility throughout each stage of the supply chain is essential to maintaining food safety. Implementing IoT Pixels enhances this visibility in multiple ways including:
Providing full product traceability from farm to store;
Promoting enhanced communication and collaboration between food suppliers, manufacturers, and distributors;
Identifying potential food safety hazards in the supply chain so they can be proactively addressed.
Temperature and Humidity Monitoring - IoT Pixels can be used to monitor the temperature and humidity of food shipments throughout the supply chain, providing additional information that can be used to ensure food safety. Specifically, IoT Pixels can:
Ensure perishable items are stored at the proper temperature and humidity;
Monitor temperatures during each phase of transportation and delivery;
Generate real-time alerts when temperature breaches occur.
FSMA 204 requires grocery stores and quick service restaurants to track the receipt of cases, totes and pallets of food that are tracked by a TLC. In the past receipt of items was often inferred based on the shipping records of distributors. This is not sufficient to comply with the recording of key data elements at the critical tracking events specified by the FDA. Hiring additional staff to use hand held scanners to record the receipt of every case of food is generally cost prohibitive. Likewise the cost of large scanning gates represents a prohibitive capital cost. Low cost Bluetooth ambient IoT readers that cost tens of dollars rather than thousands, allow TLCs and KDEs to be captured without more staff or expensive infrastructure.
Conclusion
FSMA 204 was designed to protect the food supply chain from contamination that could put public health at risk.. It involves extensive recordkeeping regarding lot traceability codes that track the movement of commodities through the food supply chain.
Companies are encouraged to implement strategies that put them in a position to comply with FSMA 204. There is still time to put the necessary procedures in place before FSMA 204 goes into full effect on January 20, 2026.
Additional resources regarding FSMA 204 are available from the following sources. Companies should make use of these resources to ensure that they are ready to perform the necessary recordkeeping and documentation the rule requires.
FDA provides documentation regarding the specifics of Rule 204.
Extensive information about FSMA training is provided by the FDA.
FAQ
What is the purpose of FSMA 204?
The purpose of FSMA 204 is to reduce the incidence of foodborne diseases in the U.S. by instituting a rigorous traceability framework that enables rapid detection and response to outbreaks of foodborne disease to help prevent them from happening and limit their effects on the population. These measures are designed to increase food safety and protect public health from foodborne diseases.
Who needs to comply with FSMA 204?
All domestic and foreign companies that manufacture, process, pack, or hold foods on the Food Traceability List destined for sale to U.S. consumers need to comply with FSMA 204. This includes every entity from the farm through packers and transportation companies to the grocery stores that sell the products to consumers.
How does FSMA 204 differ from other FSMA rules?
FSMA 204 differs from other FSMA rules in the degree of recordkeeping and documentation organizations need to perform to attain compliance. Failure to comply with FSMA 204 can result in re-inspection costs, product recalls, and the suspension of a facility’s registration to participate in the food supply chain.
When is the compliance deadline for FSMA 204?
The compliance deadline for FSMA Rule 204, which specifically relates to food traceability is Tuesday, January 20, 2026. Compliance with the rule is backed by the FDA’s power to revoke a business’ license to sell food. Any enterprise that is part of the supply chain for foods covered by FSMA 204 should be preparing for this date now.
What is a vulnerability assessment, and how is it conducted?
Conducting a vulnerability assessment is a requirement of FSMA 204. The assessment needs to identify potential vulnerabilities in their facility that may pose a risk to food safety. Each vulnerability has to be evaluated to determine the potential impact on public health. The goal is to determine the ability of internal or external entities to contaminate food and pose a threat to the public.
What are the recordkeeping requirements for FSMA 204 compliance?
Recordkeeping requirements for FSMA 204 include:
Developing a food traceability plan;
Tracking traceability lot codes throughout the food supply chain and gathering key data elements at all critical tracking events;
Providing records to the FDA within 24 hours of a request.
What are the penalties for non-compliance with FSMA 204?
The FDA can impose the following penalties for non-compliance with FSMA 204 on offending entities.
Hourly re-inspection fees are required to verify vulnerabilities have been addressed.
Product recalls may be initiated to maintain public safety.
Suspension of a facility’s registration, essentially putting them out of business.
Are there any exemptions or modified requirements for small businesses under FSMA 204?
There are exemptions and modified requirements for FSMA 204 that apply to small farms and businesses or facilities that grow produce for personal consumption. The FDA offers an interactive tool to help organizations determine if they are exempt from FSMA 204.
FSMA 204 terms and acronyms list:
FSMA 204: Food Safety Modernization Act, Section 204.
FTL: Food Traceability List.
CTE: Critical Tracking Events, which include harvesting, cooling, packing, receiving, shipping, and processing items on the FTL.
KDE: Key Data Elements. Depending on the CTE being performed there will need to be KDE records for each CTE (linked to a traceability lot).
Traceability lots: are batches of food subject to FSMA 204 that have been originally packaged, received by the first land-based receiver, or transformed.
TLC: Traceability Lot Code. Typically an alphanumeric descriptor that identifies a traceability lot. Traceability lot codes are assigned to batches of food that have been initially packaged, received from a fishing vessel, or transformed. The traceability lot code source is the location where a raw agricultural commodity (RAC) was assigned a traceability lot code.
RAC: Raw Agricultural Commodity (usually fresh produce).
For related insights, checkout Wiliot’s podcast interview with Ed Tracy of International Fresh Produce Association, and Frank Yiannas, ex FDA/Disney/Walmart architect of the FSMA 204 Rule
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