On November 15, 2022, the Food and Drug Administration (FDA) finalized FSMA Rule 204. If your organization deals with foods including cheeses, nut butters, fin fish, bivalves/mollusks, domesticated chicken eggs, certain vegetables and more, you need to be aware of what FSMA Rule 204(d) means for you.
This article will guide you on how to engage your entire team in the food traceability process, including some of the risks of non-compliance and the benefits of leveraging a bespoke supply chain and compliance solution.
The Challenge of Implementing Comprehensive Food Traceability
Under FSMA Rule 204(d), any organization that manufactures, processes, packs, or holds foods included on what is known as the Food Traceability List (FTL) must adhere to additional traceability recordkeeping and data sharing requirements. This allows for faster identification and the rapid removal of potentially contaminated food from the market. However, complying with FSMA Rule 204 presents a challenge for many organizations.
Consider that data needs to be collected each time an FTL food product changes hands or changes form. In other words, the flow of information needs to be fluid as the item moves along the supply chain. But that’s not something most shipping, receiving or warehouse management systems are configured to do.
And what if the FDA suddenly asks to be sent sortable, electronic records; would you be able to comply in 24 hours using the information contained in your disparate systems or paper records?
Now imagine a scenario where you only keep track of FTL foods for your link in the overall supply chain? Would you be confident that your suppliers are in compliance and keeping the necessary records?
Enforcement will begin on January 20, 2026. Isn’t it better to be ahead of the game and have complete confidence in your traceability solutions?
Food Traceability Is Not Just Your Food Safety Team’s Responsibility
Your QA/QC and Food Safety teams might be the ones championing your FSMA 204 compliance project and may be the ones to shoulder the consequences should non-compliance occur. But, true FSMA 204 preparedness requires involvement from your total organization. Food traceability is a supply chain problem.
The key data elements (KDE’s) around all of the critical tracking events (CTE’s) occur upstream from you, throughout your own operations, and you must share data downstream, your new food traceability initiatives are going to impact numerous departments throughout your organization. It’s necessary to get the rest of your company’s teams involved from the outset of your FSMA Rule 204(d) compliance journey to achieve the best results.
The Importance of Team Involvement in Food Traceability
As with any significant business change, it’s important to secure buy-in from every individual and department at the very start of your enhanced food traceability project. By doing so, you’ll facilitate a smoother implementation process. Furthermore, departments that are on board are more likely to embrace change, adapt to new ways of working and support the necessary transition activities.
Capturing, creating and exchanging information requires involvement from operations, information technology (IT) and merchandising, all the way up to the chief financial officer (CFO) and CEO. Buy-in from the CFO and CEO is crucial for success because they determine the course of any business and budget.
Here are some examples of how different teams could be impacted by new food traceability requirements:
- Operations – How would your operations team react if you told them that some, but not all, incoming cases have additional traceability data gathering requirements, that the cases may not be marked as such, that the format of this data may be different by vendor and/or category, and that if you rely primarily on labels every individual case may need to be scanned in and scanned out
- Merchandising – When legal requirements and brand reputation demand more traceability from suppliers than ever before, how will that impact your relationships?
- IT – Your suppliers will inevitably send cases with their own labels; are your systems ready to receive and process the information in that format, and transform it into a format/language that’s usable inside your organization?
Understanding the Risks of FSMA Rule 204(d) Non-compliance and the Need for Change
The ultimate goal of FSMA Rule 204(d) is to make food safer for everyone by having a fully transparent and trackable supply chain. Should a foodborne illness outbreak occur, the FDA can more quickly and efficiently determine the source of the contamination and prevent it from doing any further harm, and only disrupting the involved/affected parts of the supply chain.
The FDA may choose to bring a civil action or even a criminal action in federal court against individuals and organizations who don’t take prompt and voluntary action in the face of traceability non-compliance.
But aside from the possible legal and financial consequences of non-compliance, consider the cost of the associated reputational damage and loss of trust. Can you even begin to put a figure on that?
Leveraging ReposiTrak’s Solutions for a Smooth Transition
For more than 20 years, ReposiTrak has been solving supply chain collaboration challenges. Our proven supply chain and compliance platform enables farm-to-shelf traceability.
- Is easy to implement
- Meets and exceeds the FDA’s FSMA 204(d) guidelines
- Is the lowest cost with little impact to consumer pricing
Interested in learning more about the benefits of food traceability? Visit our resource page and schedule time to talk about how food traceability will revolutionize the food supply chain industry and how your company can benefit from adopting traceability practices now.