Food Traceability Rule Guide: How to Meet FSMA 204 Compliance in 8 Steps

Discover the 8 practical steps you can start taking today to get compliant with the Food Traceability Final Rule.

In January 2011, President Barack Obama signed the Food Safety Modernization Act (FSMA) into law. Now, the FSMA 204 final rule on food traceability has many businesses needing to adapt and update their food safety management systems.

The FSMA contains many sections but in this article, we'll cover Section 204(d), which outlines additional traceability record-keeping requirements for certain foods.

Food traceability refers to a business's ability to track the movement of food materials throughout the supply chain until they become finished products. In the context of FSMA 204, the traceability rule includes:

• Food Traceability List: Defines foods requiring enhanced recordkeeping and applies to both listed foods and those containing listed ingredients, provided they maintain the form specified on the FTL (e.g., fresh).
• Standardized food traceability system: Uses the FTL and Key Data Elements (KDEs) for consistent and accurate monitoring of specific foods across the supply chain.
• Enhanced recordkeeping requirements: Mandates detailed documentation of Critical Tracking Events (CTEs) for foods under regulation, ensuring a thorough audit trail.
• Food traceability plan: Requires companies to create and follow a traceability plan detailing the procedures for new recordkeeping rules, including assigning and documenting traceability lot codes along with other identifiers to trace food shipments within the supply chain.
  
  So let’s get into the what, why, when, and who of FSMA 204.

What is FSMA 204? 

FSMA 204, also known as the Food Traceability Rule, is Section 204 of the Food Safety Modernization Act, which requires the FDA to identify foods that require additional recordkeeping to protect public health.

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Why was FSMA 204 written into law?

FSMA 204 was written into law for many reasons, one of the primary ones being to more effectively minimize and mitigate food safety hazards (e.g., E. coli and Salmonella). In particular, these additional recordkeeping requirements are intended to identify and remove potentially contaminated food from the market even faster, resulting in fewer foodborne illnesses and worse, deaths.

Who does FSMA 204 apply to?

FSMA 204 applies to businesses that need to keep additional traceability records if they hold, process, pack, or manufacture foods that are specifically on the Food Traceability List. Additional record-keeping requirements include maintaining Key Data Elements and Critical Tracking Events and being able to forward these records to the Food and Drug Administration (FDA), ideally within 24 hours.

When is the FSMA 204 compliance date?

The FSMA 204 compliance date is Tuesday, January 20, 2026. It originally came into effect in January 2023, two months after the traceability final rule was published.

When does FSMA 204 enforcement start?

The FDA recognizes that food businesses will need to implement or update their traceability plans. This is something that should not and cannot happen overnight.

It's important to note that the FDA website states:

"We generally note that, while we aren’t initiating routine inspections until 2027, we may do inspections for compliance with the Food Traceability Rule on a for-cause basis, such as during an outbreak investigation, once the compliance date of January 20, 2026, is reached."

What key will terms help to standardize our understanding of FSMA 204?

Before we dive deeper into FSMA 204 compliance, let’s level set about the traceability rule terms and acronyms that we’ll be seeing a lot.

• Food Traceability List (FTL): A catalog of specific food items that require enhanced recordkeeping as stipulated by FSMA 204.
• Critical Tracking Events (CTE): A pivotal point within the food supply chain where capturing and documenting key information is essential.
• Key Data Elements (KDEs): Essential data associated with each CTE that businesses must maintain and disclose to partners in the supply chain and the FDA.
• Raw Agricultural Commodity: Typically refers to unprocessed fruits or vegetables.
• Retail Food Establishment: Locations such as stores or restaurants where food is sold directly to the public.
• Traceability Lot Code (TLC): A distinctive code allocated to a specific batch of food to facilitate its traceability throughout the supply chain, especially during recalls.
• TLC Source: The initial location or facility where a food batch is assigned its traceability lot code.

What's on the FSMA 204 food traceability list?

The idea of a designated high-risk foods list goes back to 2014 when, as required by the FSMA law, the FDA requested comments, scientific data, and information help them implement one.

Today, the food traceability list we have is a result of thorough analyses of outbreak investigations and recall data over time. The amount and frequency of outbreaks and recalls helped to determine which foods — from cheeses to popular produce — appear on the food traceability list as outlined in FSMA Section 204.

Food Traceability List items and descriptions

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In her Food Safety Fridays talk for the ISFQN community, Radojka Barycki, Owner and CEO of RDR Global Partners, shared that the FDA will review the food traceability list every five years. Since the FTL was updated in 2022, the food industry can expect an updated list of foods for inclusion sometime in 2027.

Now that you’re aware of what’s included in the Food Traceability List, you’ve got to know your CTEs and KDEs, which help to form the foundation for more safe and holistic food traceability throughout the entire supply chain.

You can see the original comprehensive list with more in-depth examples of food on the FDA's Food Traceability List page.

What are Critical Tracking Events?

Critical Tracking Events are important aspects of a food item's journey that help to decrease likelihood of contamination and reduce risk of foodborne diseases.

There are 7 critical tracking events which include:

1. Harvesting: Activities performed at farms to remove and prepare raw agricultural commodities for food use, including both growing and raising processes.
2. Cooling (before Initial Packing): The process of actively reducing the temperature of a raw agricultural commodity using methods such as hydro-cooling, icing (excluding seafood), forced air, or vacuum cooling.
3. Initial Packing (raw agricultural commodities aka RACs): The first packing of a raw agricultural commodity, excluding seafood from fishing vessels, into containers for further handling or transport.
4. First Land-Based Receiver: The first business entity on land to take possession of food directly from a fishing vessel.
5. Shipping: The act of arranging food for transport from one location to another, which includes intracompany shipments to different addresses but not direct sales or donations to consumers.
6. Receiving: The act of accepting food shipments at a new location, including intracompany transfers, but not direct consumer deliveries.
7. Transformation: Involves significantly altering the food through processes like manufacturing, commingling, repacking, or relabeling, specifically when the result is a food on the Food Traceability List.

What are Key Data Elements?

Key Data Elements are different pieces of data that are determined by the specific CTEs which businesses have to keep track of. These details should answer the who (parties involved), what (activities that occurred to the food item), when (date of the event), and where (location).

Different key data elements are required for each critical tracking event. But some common KDEs include:

• Location description of the food for where it was either harvested, cooled, packed, shipped, etc. (other than a transporter)
• Commodity (and variety of food, if relevant)
• Food quantity and unit of measurement
• Location description for the location from which you shipped the food
• Traceability lot code you assigned or traceability lot code source
• Date of harvesting/cooling/initial packing/landing/shipping/receiving/transformation completion
• Reference document type and number

For exact details and wording of what key data elements are needed for each critical tracking event, reference the FDA USDA's CTE and KDE document. (Yes, that was a lot of acronyms...)

What are Traceability Lot Codes?

Traceability Lot Codes or TLCs are unique identifiers (usually alphanumeric) assigned to items on the food traceability list to increase supply chain transparency You must assign a TLC to a food on the Food Traceability List (FTL) when you:

• Initially pack a RAC (excluding foods obtained from fishing vessels)
• Perform the first land-based receiving of food obtained from a fishing vessel
• Transform a food

What records are necessary to keep when shipping or receiving food on the Food Traceability List?

What types of food businesses are exempt from the FSMA 204 rule?

A number of businesses are exempt from food traceability with either full exemptions, partial exemptions, or full and partial exemptions. You can find the exact answer to “What foods and persons are exempt from this subpart?” in Section 1.1305 in the Code of Federal Regulations.

Here’s a high-level overview of the business types that fall under these exemption categories:

Full exemptions

• Small producers: Certain producers of small scale are fully exempt
• Direct-to-consumer farms: Farms selling or donating food directly to consumers
• Low-risk produce: Produce typically not consumed raw
• Seafood: Raw bivalve molluscan shellfish
• USDA-regulated entities: Entities that manufacture, process, pack, or hold foods regulated by USDA
• Transport entities: Companies that transport food
• Nonprofit organizations: Nonprofit food service establishments
• Personal use: Individuals who handle food for personal consumption
• Research food: Food designated for research or educational purposes

Partial exemptions

• Mixed commodities: Commingled raw agricultural commodities
• Small food services: Small retail food outlets and eateries
• Direct purchase restaurants: Restaurants buying directly from farms
• Cross-purchasing retailers: Retail food entities buying from other retail locations
• Educational programs: Farm to school and other institutional programs
• Fishing vessels: Individuals or entities managing fishing operations

It’s important to note that exemptions aren't always clear-cut. Sometimes, a company might not need to keep certain records for some types of food but will need to keep them for others.

Also, a company might be exempt from some rules at one stage of moving food from place to place, but later stages could still require following those rules. This shows how some foods that usually don't need detailed records might still need them when they reach someone else down the line.

Want to see whether or not your business is exempt from FSMA 204 regulations, use the FDA’s Exemptions to the Food Traceability Rule interactive flow chart.

(If you’d like, try the exemption tool above to clarify if you will have to seek FSMA 204 compliance before jumping into the steps below.)

8 Steps to get compliant with FSMA 204

Below, we’ll get into the practical steps you can start taking to ensure your food business is ready for FSMA 204 compliance in time for January 20, 2026:

1. Create an FSMA 204 compliance team
2. Get familiar with FSMA 204 requirements
3. Establish the scope of implementation
4. Assess your operation’s traceability and data compatibility
5. Conduct internal gap and risk assessments
6. Implement the FSMA 204 compliance plan
7. Assign traceability tasks and start tracking
8. Prioritize continuous improvement

1. Create an FSMA 204 compliance team

To ensure your business aligns with FSMA 204 regulations, start by forming a compliance team. This group should be composed of key personnel who understand the complexities of your food operations.

Including a mix of roles, such as operations managers, quality assurance specialists, and IT staff, is beneficial to cover all aspects of the compliance process. Importantly, the team should be led by a Preventive Controls Qualified Individual (PCQI), who brings essential knowledge of FSMA requirements.

When assembling your team, consider the scope of your operations and the specific needs related to FSMA 204 compliance, such as traceability and preventive controls, ensuring each member is clear on their roles and responsibilities. In a typical food business, for example, an FSMA 204 compliance team could look like this:

This structured approach will not only facilitate smoother implementation but also enhance ongoing compliance efforts. If you’ve already got a PCQI to generally maintain FSMA compliance, you’ll be off to a good start.

2. Get familiar with FSMA 204 requirements

Knowledge is power and knowing what the food traceability rule expects of you will make the compliance journey much easier. Start by reviewing the official final rule and lean on resources like the one you’re reading now. Build a comprehensive resource list that includes eBooks, webinars, and presentations from the FDA and other experts to deepen your understanding.

Here’s a starter list:

• FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods
• Food Traceability Rule Resources Walkthrough on FDA.gov
• The FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods
• FSMA 204 Food Traceability List poster
• FSMA 204 Compliance eBook

Also, refer back to the glossary section earlier in this article to familiarize yourself with key terms like FTL, CTE, KDE, and TLC, ensuring that all team members have a solid foundation in the terminology and requirements of FSMA 204.

3. Establish the scope of implementation

Understanding the traceability rule's impact on your specific business operations is crucial. Take these steps to help determine the scope of FSMA 204 compliance:

• Begin by reviewing the Food Traceability List to identify which of your products or ingredients are affected.
• Document your current traceability processes to determine how you manage and track these FTL items.
• Next, develop or refine your strategy for capturing the necessary data, such as lot or batch numbers, dates, and quantities.

Essentially, assess your existing food traceability program to ensure it meets the transparency and safety requirements throughout your supply chain.

4. Assess your operation’s traceability and data compatibility

Start by pinpointing your company's role in the supply chain to understand your specific responsibilities under FSMA 204. Do you hold, process, pack, or manufacture foods? Is it a combination?

Examine your current systems for tracking and managing traceability data to see how well they align with FSMA requirements. Check how you currently receive, or plan to receive, traceability data from your suppliers.

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Engage in discussions with your customers, trading partners, and technology providers to gather insights on their FSMA 204 compliance strategies. In addition to creating an FSMA compliance statement of your own, request to see your supplier’s statement to make sure their food safety compliance goals align with your company’s.

Evaluate whether your trading partners are prepared for FSMA compliance, ensuring that all links in your supply chain are ready to meet these regulatory requirements. You can start with your approved suppliers list and based on their FSMA compliance (or lack thereof), you can decide whether you’ll need to source new ones.

This holistic approach will help you identify any gaps in your current system and facilitate a smoother transition to full FSMA 204 compliance.

5. Conduct internal gap and risk assessments

Compare your current systems to FSMA 204 requirements to uncover any discrepancies. Common gaps might include inadequate data capture capabilities or insufficient traceability measures for items on the Food Traceability List.

Review the impact of these gaps on your systems, hardware, and operational procedures.

• Systems: Non-compliant systems may lead to inefficient tracking and reporting, potentially causing delays in identifying and addressing food safety issues.
• Hardware: Inadequate hardware could fail to support new software requirements for data logging and real-time tracking, limiting your ability to maintain continuous oversight.
• Operational procedures: Gaps might result in flawed procedures that do not ensure all key data elements are captured, leading to incomplete records that could jeopardize both compliance and responses to food safety incidents.

You should also assess potential risks in your traceability system, such as the vulnerabilities of a paper-based system versus the benefits of adopting food traceability software. Searching through piles of paper for specific food safety monitoring records when the FDA gives you just 24 hours to provide the recall data becomes a lot more stressful and difficult. With digital traceability logs, you can share the information with the FDA in seconds.

6. Implement the FSMA 204 compliance plan

To effectively implement your FSMA 204 compliance plan:

• Start by identifying the Critical Tracking Events that pertain to your operations.
• Establish a system for consistently collecting and managing Key Data Elements associated with these CTEs.
• Standardize your Traceability Lot Code system to ensure uniformity across all products and processes.
• Develop FSMA 204-specific Standard Operating Procedures (SOPs) to guide your team's daily activities.
• Provide comprehensive training for your team, which could include in-person sessions, video courses, or step-by-step instructions integrated within your software applications.

7. Assign traceability tasks and start tracking

For effective traceability management, assign role-based traceability tasks using your chosen system — paper-based or digital. Here's a list of typical traceability monitoring tasks in a food business:

• Logging incoming raw materials with batch numbers and source details.
• Tracking processing and packaging activities with time or temperature stamps.
• Recording storage conditions and durations.
• Documenting shipments with destination and carrier information.

Managing these tasks with a paper system can be challenging due to the manual effort required, the potential for human error, and difficulties in quickly accessing specific data during audits or inspections.

Transitioning to a digital traceability system offers significant benefits, such as real-time data updates, improved accuracy, and easier access to traceability records, enhancing overall food safety compliance and operational efficiency.

8. Prioritize continuous improvement

Regularly monitor and review your food traceability program and FSMA 204 compliance, establishing a review cadence that aligns with your business operations.

Incorporate training sessions and mock audits as part of this ongoing process to keep your team sharp and prepared. You can use the FSMA compliance checklist and place a particular focus on the final Recall section.

Be prepared to re-assess your compliance strategies, particularly when significant operational changes occur or when new regulations are introduced, such as the FDA's updates to the Food Traceability List every five years. This approach ensures that your compliance measures evolve and improve continuously, staying effective and relevant.

January 2026 seems far away, but in the context of food safety and the change management inevitably involved in implementing a plan and system that works for your team, it will approach faster than you think.

Getting buy-in at every level of the business, sourcing new or better compliant suppliers, and making other necessary changes in your organization can take several months or even over a year.

And why wouldn't you? If you're a business that's directly impacted by FSMA Rule 204, getting compliant will help to:

• Protect your customers from a foodborne illness outbreak
• Reduce the risk of financial loss
• Ensure compliance with regulations
• Protect your business's brand reputation

Look at that, those four bullet points create an apt acronym: PREP. And on that note...

How do you choose the right FSMA 204 food traceability software?

Regarding having what you need, many businesses choose to digitize their food safety system. Leveraging the right food safety software will help your team:

• Meet and maintain compliance with the standards of your choice
• Complete monitoring and traceability logs with less human error
• Safely store and gain instant access to food safety records at all times

Regardless of what food traceability software you choose, make sure it's able to support the specifics outlined earlier in FSMA Section 204's key features: critical tracking events and key data elements, traceability lot codes, traceability plan, as well as additional requirements.

How FoodDocs helps you manage FSMA 204 compliance

Would you like to make traceability logging and recall management easier? FoodDocs’ software is built so you can log your traceability within seconds, saving time on repetitive activities and making the whole traceability process easy to trace in case of a recall.

• Intuitive and simple: FoodDocs' traceability system is easy to use and applies to all traceability needs.
• Quick and efficient logging: Create traceability logs within seconds to save time and effort on repetitive activities.
• Easy recall management: Instantly access detailed recall information about products and ingredients to ensure quick and effective responses.

Using FoodDocs' smart Food Safety Management System equipped with an all-in-one effective Traceability System fulfills your production and traceability needs.

In addition to the most critical and primary features of a food safety management platform, our smart software features a Traceability System with the following benefits:

Traceability System for accurate tracking of ingredient and product movement

You can create traceability logs with just three clicks. Enter all product information, including:

1. Product name
2. Ingredients
3. Batch number/ Production dates
4. Target amount
5. Expiry date

All essential information needed to track the movement of your ingredients and products and for recalls is conveniently presented in one custom food traceability software.

Managers can attach monitoring tasks to traceability information, such as cooling temperature or dispatch records, to further support record-keeping. They can also attach receiving temperature tasks to ingredients using the monitoring feature and, based on batch numbers, still access relevant traceability data.

In case of a recall or inspection, you can find historical traceability logs in seconds using the advanced search filter. This will give you instant access to information based on entry date, expiry date, product batch, and ingredient batch data. And if you want to further analyze specific batches of food information, simply download the data as a CSV or XSLS file.

While food safety teams can log traceability information on desktop, logs are much easier to complete with the FoodDocs mobile app — available on both Apple iOS and Android.

Digital recipe book for organizing all recipes and instructions

Ensure that all of your recipes are organized in cloud storage with the help of our Digital Recipe Book. With this feature, you can log all recipe information, including the following, to our system:

1. Recipe name
2. Ingredient amounts
3. Preparation steps
4. Allergen information
5. Shelf-life information
6. Image of the final product

The information logged into our Digital Recipe Book is also used to automatically calculate how much food you're preparing and the expiration dates of products.

Use this smart solution to ensure food handlers have access to proper food preparation and reference for the correct business processes.

Track shelf-life automatically based on information provided in recipes

Once you log individual product or ingredient shelf-life information in our Digital Recipe Book, you can receive intuitive alerts about shelf-life reminders.

With this feature, you can access accurate data for labels and ensure that all food ingredients and products are optimized before spoilage to reduce food waste.

With the help of our comprehensive food traceability software system, you can be confident that all ingredient and product information is well-organized and can be accessed easily in case of future recall events or inspections.

Whether you're holding, manufacturing, processing or packing items on the Food Traceability List, you can gain a competitive advantage by using food traceability software. Give FoodDocs' a try with a 14-day free trial and take your next step toward FSMA 204 compliance.

Frequently asked questions about FSMA 204, the food traceability rule