FSMA 204 Guide: Final Rule, Food Traceability List, Compliance Date, and More

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.mThe FSMA contains many sections but in this article, we'll be covering 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. Traceability systems allow business owners to track the flow of food ingredients and products in the entire supply chain. This creates more transparency among supply chain partners for a food product's state and safety throughout the production process.

So what's different about FSMA 204?

What is FSMA 204? Who needs to follow it?

FSMA 204, also known as the Food Traceability Rule, 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 (FTL). Additional record-keeping requirements include maintaining Key Data Elements (KDEs) and Critical Tracking Events (CTEs) and being able to forward these records to the Food and Drug Administration (FDA), ideally within 24 hours.

Key features of the Food Traceability Final Rule

The FDA outlines four key features of FSMA 204:

1. Critical tracking events and key data elements

CTEs and KDEs help to form the foundation for more safe and holistic food traceability throughout the entire supply chain.

In the context of the FDA's Food Traceability List (which we include in full below), 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.

Critical tracking events include:

• Harvesting
• Cooling (before Initial Packing)
• Initial Packing (raw agricultural commodities aka RACs)
• First Land-Based Receiver
• Shipping
• Receiving
• Transformation

Key Data Elements are different pieces of data that are determined by the specific CTEs which businesses have to keep track of.

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, e.g., 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...)

Historically, the FDA has defined "traceability" as the point at which you receive raw materials to the time you process and ship a food product. But in light of continued recalls and a need for faster identification when it comes to the source of contamination, the FDA's addition to the FSMA makes it clear that the traditional one-step-forward, one-step-backward record-keeping rule is insufficient for accomplishing true food traceability.

That's why, in order to go more than one step forward or backward, the FDA is placing greater emphasis on stricter documentation and record-keeping of those critical tracking events.

2. Traceability Lot Codes (TLCs)

To increase supply chain transparency, a TLC, usually alphanumeric, is a unique identifier assigned to items on the food traceability list. 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 a food obtained from a fishing vessel
• Transform a food

3. Traceability plan details

As a business that's subject to FSMA 204 requirements, your traceability plan must include details covering:

• Procedures for maintaining traceability records (including format and location)
• Procedures for identifying FTL items that you hold, manufacture, process, or pack
• Procedures for assigning traceability lot codes to those FTL items
• Information outlining your point of contact for company traceability-related questions
• Maps that detail where you grow or raise food, e.g., the name and location of each field or container (if you're a farm that doesn't produce eggs)

4. Additional FSMA 204 requirements

FSMA 204 also requires that businesses must:

• Maintain their chain of traceability records on paper or digitally, so long as records are legible
• Make those records available to the FDA within 24 hours of a request (or within a reasonable time agreed upon with the FDA)
• Provide the FDA with an electronic sortable spreadsheet containing relevant traceability information with the same timeframe to assist the FDA during an outbreak, recall, or other public health threat (unless exempt)

What is the FSMA 204 not?

In an effort improve food supply chain visibility and transparency, FSMA 204 mandates the what, i.e., improved record-keeping and reporting of traceability lot codes. But what FSMA 204 does not do is mandate the how. Specifically, it doesn't require food businesses to fulfill these new requirements in a particular way (i.e., paper records vs electronic records).

However, given that the FDA requires you to submit traceability data with 24 hours (unless you establish another agreed upon timeline), paper records could pose more challenges that prevent you from doing it in time, such as:

• Damaged records due to tears, creases, or stains
• Misplaced records due to loose or disorganized filing
• Illegible or incorrect traceability logs due to human error

Frank Yiannis, former FDA Deputy Commissioner, also notes monitoring records that the Traceability Rule doesn't require, including:

• Certified compliances
• Climate data
• Collateralized debt obligations
• Costing data
• Inventory utilization (e.g., warehouse optimization, storage scheduling)
• Positional data (i.e., geographic coordinates)

The reality is food safety software can help teams more accurately and securely store records, and access them in the case of a recall that requires rapid removal of food. FoodDocs' Traceability software allows teams like yours to:

• Create traceability logs within seconds
• Automate shelf-life date tracking and smart reminders
• Quickly and easily access detailed recall data — by lot numbers — about products and ingredients, and more

Now you know what FSMA 204 is, what this traceability rule is not, and what's required of businesses. But...

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.

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 some time in 2027.

Food Traceability List items and descriptions

Download the FSMA Food Traceability List poster as a free 3-page PDF.

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

FSMA 204 compliance date: when does enforcement start?

Mark your calendars: the FSMA 204 compliance date is Tuesday, January 20, 2026.

FSMA 204 went into effect on January 20, 2023 but 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."

Recent FSMA 204 developments (as of May 2024)

A group of U.S. politicians recently introduced a legislation called the Food Traceability Enhancement Act. It proposes implementation changes which aim to “strengthen compliance” with the Food Traceability Final Rule.

If the bill ends up passing, it would lessen the TLC and record-keeping requirements for restaurants, food retailers, and warehouse facilities. Specifically, these types of businesses would no longer be required to maintain TLC data nor send the data to supply chain partners or to the Secretary of the U.S. Department of Health and Human Services (the Secretary).

Another change in particular includes delaying the compliance date to at least two years after the completion of the pilot projects, of which the bill proposes nine or more that the Secretary would have to conduct.

The proposed pilot projects would seek to gauge the effectiveness of foodborne illness investigations without available traceability lot code data, as well as evaluate low-cost food traceability technologies.

For more information about the Food Traceability Enhancement Act, here's the official proposed bill.

Check out our free customizable FSMA Compliance Checklist.

FSMA 204 sentiment: a pulse on how food safety workers are feeling

The sentiment among food safety workers isn't the most positive. There are many people who are unsure of how to properly move forward, and not for lack of trying. The IFSQN forum saw a recent topic titled "Is anyone else struggling with the FSMA204 Final Rule regulations?"

People who responded shared legitimate concerns, such as:

• "We are struggling with our GDST (Global Dialogue on Seafood Traceability) and syncing it to our current ERP and feels like we're doing it blind."
• "I also forecast we'll have some struggles with our smaller farms and packing houses to sort through whatever hodgepodge they come up with for sending the KDE's to us."
• "I really struggle to figure out how to get out of the weeds and have some traction to this data while higher-ups are demanding implementation plans and presentations... we are just not there yet."

This is not a one-dimensional issue. It involves management, the state of food safety technology, those who are writing and enforcing FSMA 204, and more.

These concerns are exactly why, if in this moment, regardless of whether or not the FSMA 204 compliance date gets delayed, you know that you're food traceability plan is non-existent or not where it needs to be, our message is this: do not wait.

January 2026 seems far away but, in the context of food safety and the change management inevitably comes with 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 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...

3 Important questions you need to start asking if you want to meet FSMA 204 compliance in time

1. Do we understand how FSMA 204 applies to our food business? Determine whether or not you're you a packer, processor, holder, or manufacturer of anything on the Food Traceability List. Get crystal clear on the critical tracking events and accompanying key data elements you need to track and keep records of on an ongoing basis.
2. Do we know how we're going to meet FSMA 204 traceability requirements? Align on your business's method of record-keeping (i.e., will you be keeping paper or digital food safety records?). Check if your traceability plan currently covers what's required by the the updated law, or if your business needs to adjust its processes and tools to, for example, provide the FDA with traceability records within 24 hours.
3. Do we have what we need in order to successfully be FSMA 204 compliant? Based on your answers to questions one and two, examine where gaps or questions still exist. You might determine that you need an FSMA 204 consultant, or that your existing paper-based records pose too high a risk to your compliance.

Choosing the right FSMA 204 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 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 the additional requirements.

How FoodDocs is helping food businesses get compliant for FSMA 204

Using FoodDocs' smart Food Safety Management System equipped with a 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

With our Traceability System, 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 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 and take your next step toward FSMA 204 compliance.