Oct 30, 2023

How to Stay Compliant with FSMA Traceability Requirements

Food manufacturers working on food traceability

As a food company, you’re likely very familiar with The Food Safety Modernization Act (FSMA). Signed into law in 2011, its purpose is to shift the focus of the nation’s food safety system “from responding to foodborne illness to preventing it.” And while you’re likely well-versed in the many rules the FDA has finalized to implement FSMA throughout the past decade plus, you may be less familiar with its latest rule regarding traceability: Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule). With a required compliance date of Tuesday, January 20, 2026, it’s time to become familiar with the ins and outs of what this rule entails – from what FSMA 204 is to how it applies to food companies and what you need to do to be compliant to how food traceability software can help.

What is FSMA 204 and what do I need to do to be compliant?

The Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule) “is a key component of FDA’s New Era of Smarter Food Safety Blueprint and implements Section 204(d) of the FDA Food Safety Modernization Act (FSMA),” making it commonly referred to as FSMA 204. But how can you make sure you’re compliant with these new requirements? The first step in being compliant with the FSMA traceability requirements is understanding what they even are.

As an addition to the existing FSMA regulations, FSMA 204 was created to improve the speed, availability, and accuracy of the critical food traceability data needed for recalls. According to the FDA, it requires “that persons subject to the rule who manufacture, process, pack, or hold foods on the FTL [Food Traceability List], maintain records containing Key Data Elements (KDEs) associated with specific Critical Tracking Events (CTEs); and provide information to the FDA within 24 hours or within some reasonable time to which the FDA has agreed” and it applies to domestic and foreign companies that produce food for consumption in the United States. Additionally, a Traceability Plan is required for everyone covered by the rule.

To understand what this requirement means, we need to understand what the Food Traceability List, Key Data Elements, Critical Tracking Events, and records containing these refer to, as well as what the Traceability Plan entails – so let’s break it down:

The Food Traceability List includes but is not limited to most fresh fruit and vegetables, most fresh and frozen seafood, soft cheeses, shell eggs and nut butters.
Critical Tracking Events are critical points of transfer or transformation in a supply chain and include harvesting, cooling, initial packing, first land-based receiver, shipping, receiving, and transformation.
Key Data Elements refer to a specific set of data required to be collected at each CTE to maintain the ability to trace products and these sets of data vary depending on the CTE performed, however, some examples include event dates, lot codes, and product descriptions.
The final rule also requires records “be maintained as original paper or electronic records, or true copies” and “an electronic sortable spreadsheet containing relevant traceability information must be provided to the FDA within 24 hours of a request (or within some reasonable time to which the FDA has agreed) when necessary to assist the FDA during an outbreak, recall, or other threat to public health.”
The FDA requires establishing and maintaining a Traceability Plan which includes descriptions of record maintenance procedures, procedures used to identify foods on the Food Traceability List that you manufacture, process, pack, or hold, and how you assign traceability lot codes, in addition to a point of contact and more if you grow or raise a food on the Food Traceability List other than eggs.

Visual examples of the relevant CTEs and KDEs among various supply chains can be seen below, courtesy of the FDA.

Finally, the penalty for not complying with the final rule depends on the nature of the violation. The FDA may issue an advisory action letter, notifying you of the violation(s) and prompting voluntary compliance. If you still do not comply, “the Federal government may bring a civil action in Federal court to enjoin persons who commit a prohibited act. The Federal government may also bring a criminal action in Federal court to prosecute persons who commit a prohibited act.” Additionally, an article of food may be refused admission if it appears the recordkeeping requirements were not met.

To understand more about if and how FSMA 204 affects your company, you can visit the FDA’s frequently asked questions about the FSMA traceability rule.

How will adhering to the new FSMA requirements affect food companies?

Now that you have a basic understanding of what the FSMA 204 requirements are, you may still be confused as to how they apply to your food company and, more importantly, concerned over how becoming compliant will affect your business. You’re not alone.

When speaking with Louis-Jean Vixamar, Founder and President of Food Safety Resource Group, he indicated that the top two concerns the companies he works with have over these new requirements boil down to competency and cost. First, do they have the competency internally to understand and build what they need to comply and second, what will it cost them to implement new systems and procedures to be compliant? In his work with these companies, Vixamar has found a lot of confusion around what the requirements are, who’s exempt and what it means for critical tracking events. For companies who repack or import product without further processing the confusion can be even greater as they don’t know where to start because they didn’t historically have traceability requirements or a designated quality person as this is the first strict regulation on traceability for companies like this. And, while a lot of FSR Group’s clients have current systems they use for traceability, having someone competent enough to understand the requirements of FSMA and their system to match the two is of concern. This is why FSR Group’s initial recommendation is for companies to do a risk analysis to see where they’re at today, which they help with, and then they help their clients understand what data they need to be tracking. As such, Vixamar believes from his experience that it’s likely most companies will have to create a new position to support traceability compliance, which he says is in line with the general consensus across the industry.

How can food traceability software help?

While FSMA 204 does not require the use of digital solutions, in order to meet the record-keeping requirements, most will require a traceability solution to collect and exchange data, according to the FSMA 204 Compliance and the Importance of Interoperable Traceability webinar. Vixamar echoed this sentiment as he explained the new requirements are seemingly pushing companies away from manual record-keeping, which further compounds food companies’ concerns as they need new tools they can implement digitally and they worry about the competency to implement these systems and, once implemented, getting the training, support, and functionality they need to understand how to use them to their full extent.

Moreover, remaining compliant to FSMA is not the only traceability concern food companies may have. Although FSMA has some exemptions, frozen tomatoes for example, and it may not ask for certain data points, that doesn’t mean your customers don’t want it. Customer expectations may often be higher than FSMA’s, meaning they may want data quicker than 24 hours and they may want more data tracked and accessible via labeling. As such, the Global Dialogue on Seafood Traceability combined with the Global Food Traceability Center (GFTC) and the Institute of Food Technologists (IFT) note that the additional benefits of traceability beyond FSMA compliance include improved, quality assurances, increased consumer trust, supports core business needs, data verifiability, helps ensure legal origins of food, easier regulatory compliance, seamless data sharing, and cost savings.

All of these benefits and concerns can be aided with the help of food traceability software. According to the National Fisheries Institute, though not required by the rule, “using computer software will help reduce the burden on data and record management.” This is because to meet the new FSMA traceability requirements in a manageable way, you need to collect data in an efficient way to be able to analyze and sort it very quickly and accurately, without a lot of manual effort.

With NorthScope ERP software for food companies, you can stop spending time on administrative tasks and start focusing on strategic planning, all while adhering to the FSMA. As a single source of truth, NorthScope helps you master the compliance standards by providing the ability to track your product no matter where/how you bought it or where it’s going. Whether it’s farm to fork, dock to delivery, you’re buying from a vessel, blending ingredients, repacking, etc., NorthScope provides a comprehensive traceability system with:

Tracking across multiple sites at the granular lot level detail.
Perpetual inventory balances that allow you to trace today or last month/year to see what inventory was where at any point in time.
One-click forward backward trace report to show where product went and where it came from.
Quality data recording and analyzing that can be related to lot traceability.
Lot certification assignments.
A dedicated team and process built to hold your hand through implementation and beyond, all while sticking to budget.

Where do you go from here?

While you may think that because you already have a comprehensive electronic system to assign and track lots from receiving to shipping you don’t need to be concerned with the new Traceability Rule, NFI explains, “The Traceability Rule has requirements not typically covered in the traditional traceability program such as the Traceability Lot Code (TLC) and TLC Source, and Traceability Plan just to name a few. It is important to check the details in the rule to see if you meet all the requirements.” After reading this summary, you may have a better idea of what the requirements are and how they apply to you, but where do you go from here? Getting a system in place that can capture all the necessary traceability data for your records would be a good place to start. Book a NorthScope demo today to see how we can help.

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