4 Myths About FSMA 204 Dispelled
August 11, 2023
There are misconceptions about how to comply with FSMA 204—FDA’s Final Food Traceability Rule—that make the rule appear more complicated than it actually is. In previous articles, we’ve looked at many different topics from the basics of what you need to know about FSMA rule 204, common questions about FSMA 204, and what to consider when choosing a supply chain traceability solution partner. Today, we’re going to look at and debunk the most common myths about these regulations.
It’s important to remember that the rule established by the Food Safety Modernization Act does not take a one-size-fits-all approach to compliance, recognizing that each organization in our food supply chain is unique in its own way. The traceability plan you develop to comply with FSMA 204 can incorporate the processes and requirements you already have in place.
We want to ease your concerns about four of the most common myths that have surfaced in recent months and provide facts and resources to consider as you look towards the January 20, 2026 compliance deadline.
MYTH #1: You must require all your suppliers to send their data via the same method, such as an Advance Shipping Notice (ASN).
The bottom line is that your suppliers can use whatever system and tools best fit their operation as long as they enable you to capture, store and share Key Data Elements (KDEs).
There are multiple ways data can be shared: CSV flat file, ASN/Electronic Data Interchange (EDI), API, or a cloud-based tool like the iFoodDS applications.
You will need visibility into your supplier networks to make sure they are collecting and sharing KDEs. Read our blog “Are Your Suppliers Sending You the Information You Need to Comply with FSMA 204?” to learn more.
Evaluate your current systems, too. Are you capturing the required KDEs? Can you receive and ingest your suppliers’ data?
ASNs are a great way to share traceability data, but are by no means the only way. Their electronic format makes sending the information easy and quick. Other benefits include accurate transfer of data, improved inventory management, and warehouse efficiency.
There are limitations in using ASNs. For example, when adapted to capture the required KDEs, ASNs still only cover part of the rule. You will need other systems and/or processes to ensure full compliance across all Critical Tracking Events (CTEs) if you are responsible for sharing more than just shipping KDEs.
There is no requirement to use a solution provider or even to use a digital solution at all, but it is something to consider. Look for a solution provider that can receive and store data from multiple sources and in multiple formats so that you can have it readily available.
A food tracebility solution provider like iFoodDS offers program management, technical and communication support, and onboarding services to help your suppliers quickly and efficiently comply with your FSMA 204 requirements.
MYTH #2: You must scan every case that leaves your distribution center to trace it forward to the restaurant or store.
There are no requirements in the rule about scanning cases leaving the distribution center. You must capture the required KDEs for each shipment, but the rule does not specify how you need to do that.
Technology solutions can work together to minimize the impact that tracking outgoing product can have on information technology (IT) and quality control resources. For example, a Produce Traceability Initiative (PTI) case label includes a Voice Pick Code that can help facilitate tracking from the DC to the store without scanning.
It’s important to make sure you have processes and systems in place to accurately track what is in your shipment. Your pallet label should reflect the contents of the pallet, including number of cases for each unique product. An ASN will also contain information about what is in the order. If you adopt using ASNs to send to your customers, make sure the ASN captures all relevant Shipping KDEs.
Evaluate your current systems to see what data is currently being captured and how it can be pulled together. Does it meet FSMA 204 compliance requirements and can it be pulled into an electronic sortable spreadsheet? If not, you’ll need to outline you plan to correct this to ensure all the data you’re responsible for is being captured.
Grocery retailers have been concerned that key processes or receipt at the store will be slowed by tracking requirements. Read our blog “The Benefits of Early Rule 204 Compliance for Grocery Retailers” to take a deeper dive into these tracking concerns.
MYTH #3: Complying with FSMA Rule 204 requires a massive IT effort.
Complying with Rule 204 can be a massive IT effort if an organization tries to do it all on its own. However, the right partner can smooth the path to compliance.
This is another reason to consider engaging a solution provider. The right one will have an in-depth understanding of the rule and how to leverage data that is already in existing systems to create an electronic sortable spreadsheet. Check out our solution provider checklist to make sure the one you choose meets minimum requirements.
The right partner will be able to help identify any data gaps and recommend tools for capturing the missing data that can be used with existing workflows. Additionally, you will want to organize requirements for your IT department ahead of time so their involvement is minimal and ensure your solution provider will handle ongoing training and technical support.
Selecting a partner experienced in the fresh food supply chain is essential to secure you’re confidence that they understand your business and workflows.
MYTH #4: My vendor has it handled. I don’t need to do anything.
The faulty logic: You can relinquish legal liability for capturing KDEs to a vendor if they are managing traceability for you.
You may have another entity establish and maintain the required records, but you are responsible for ensuring that such records can be retrieved and provided onsite within 24 hours of request for official review by FDA.
First, you must ensure providers are credible and reliable in capturing and storing data (for at least two years), and that you can quickly access your electronic sortable spreadsheet when required to do so. You cannot simply rely on solution providers who state “trust us, we have it handled.” Hold them accountable and be confident you can quickly and easily access your data.
No matter what your situation is, you are still liable for the required data and record keeping outlined in FSMA 204.
Demystifying FSMA 204
While we’ve covered the most common myths we see concerning FMSA 204, these will not be the last misconceptions to darken your door in the coming months. The best defense is to educate yourself and draw on resources provided by FDA, iFoodDS, and our colleagues at New Era Partners.
At fda.gov you’ll find the rule itself on the page entitled FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods, as well as information on key components of the rule and how to prepare for compliance.
iFoodDS has a FSMA Rule 204 Information Hub that is designed to be an educational resource for the full supply chain.
View the FSMA 204 Timeline prepared by New Era Partners to start learning about and planning for FSMA 204 compliance.
Now is the time to work on getting your internal processes in place and defining those processes with your supply chain partners. It’s important to start now as it can take months (or longer) to get your organization and full supply chain onboard.
Remember that you do not have to do this alone. Food traceability technology solutions like iFoodDS can help grocery retailers, foodservice operators and distributors comply with FSMA 204 more easily. We’re in this together.