Are You Prepared for FSMA Rule 204? Here’s What You Need to Know
By iFoodDS Team
June 6, 2022
The FDA is set to finalize FSMA proposed Rule 204 on November 7, 2022. What are you doing to prepare for compliance with the new requirements? Have you thought about how you can leverage traceability as a competitive advantage and brand differentiator?
Companies who focus merely on compliance and on their single link in the supply chain are missing out on the opportunity to shape the future of food safety. Furthermore, they are exposing their company to potential risks such as reduced consumer trust and limited visibility into their supply chain that could hinder product quality and safety. Read on to learn about the background of Rule 204 and why you should start thinking beyond compliance.
What Is FSMA Rule 204?
In 2011, the Food Safety Modernization Act (FSMA) was signed into law. Section 204 of FSMA, the Food Traceability Proposed Rule, calls for the FDA to create a list of foods (the Food Traceability List) that need additional recordkeeping and establish those recordkeeping requirements.
What Is the Food Traceability List?
The Food Traceability List (FTL) is a list of the foods that will be subject to additional recordkeeping requirements under FSMA Rule 204. The FDA released a draft list in 2014 and will finalize it when the final rule is published. So far, the FTL includes:
- Many fresh fruits and vegetables, including all leafy greens, melons, sprouts, cucumbers, tomatoes, peppers, fresh herbs, tropical tree fruits, and all fresh-cut items.
- Soft ripened and semi-soft cheeses
- Shell eggs
- Nut butter
- Some categories of seafood
- RTE deli salads
What Are the FDA Food Traceability Requirements?
If you grow, ship, pack, process, manufacture, or sell any of the foods on the Food Traceability List, you are required to keep additional records on these items. The FDA has defined a set of metrics called Key Data Elements (KDEs) that correspond to different events in the supply chain known as Critical Tracking Events (CTEs). The CTEs are:
To determine what KDEs and CTEs relate to your company, consult the FDA’s resource guide, Which Key Data Elements Would Apply to Me? Depending on the details of your business operation, you may need to capture multiple sets of KDEs. For example, a processor could be considered a receiver and a transformer since they take physical possession of product from a grower or supplier and they also cut, repack, or otherwise transform the product.
It’s also important to note that the FDA has created a distinct role known as first receiver. A first receiver is defined as “the first person (other than a farm) who purchases and takes physical possession of a listed food.” The FDA clarifies that the first receiver role is designed to accommodate on-farm activities where product may be moved but not sold (e.g., sent to a cooler on the farm).
In addition to capturing these KDEs, the FDA has outlined these requirements:
- Maintain records as original paper records, electronic records, or true copies (must be legible and stored to prevent deterioration or loss).
- Provide traceability records to the FDA no later than 24 hours after a request is made.
- Provide an electronic sortable spreadsheet containing relevant traceability information to the FDA within 24 hours of a request when necessary to assist during an outbreak, recall, or other public health threat.
When Does FSMA 204 Go Into Effect?
FSMA Rule 204 will go into effect in January 2023, 60 days after the final rule is published in November 2022. The FDA will give companies a period of two years to comply, so you will have until the year 2025 to become fully compliant. However, it is imperative for companies to start preparing now since vetting and implementing a food traceability solution takes time and careful consideration. If you wait until after the rule is published to start preparing, you may find it difficult to meet the 2025 deadline.
What Can I Do to Prepare for FSMA Rule 204?
Here are 6 steps you can take now to prepare for FSMA Rule 204:
- Identify any of your commodities – or ingredients that go into your products – that are on the current draft of the Food Traceability List.
- Familiarize yourself with the Critical Tracking Events and understand what Key Data Elements you’re required to track and store based on your role in the supply chain.
- Ensure these Key Data Elements are captured and stored in a way that’s easily accessible.
- Talk to your supply chain partners about what they are doing to prepare for Rule 204.
- Harmonize your labels across all suppliers and consider using labels that align with PTI standards.
- Start vetting traceability solutions now, keeping in mind what features you will need and which solutions offer that.
Although the FDA permits paper records, many companies will turn to technology to help them meet FSMA Rule 204 requirements. If you’re considering a digital traceability solution, look for a platform that automates KDE collection and stores the data securely so you can access it as needed. Another important feature is on-demand traceback and traceforward. You’ll want the ability to trace a product down to the lot level in case of an investigation or recall.
Why Compliance Isn’t Enough
FSMA Rule 204 appears to be a concerted effort to get the industry on the same page when it comes to traceability. However, companies who focus merely on their own link in the supply chain will be left behind in the coming years as the top companies in the industry embrace full supply chain visibility.
The industry needs to work together to solve major food safety issues. Foodborne illness outbreaks harm public health, erode trust, and cost companies billions of dollars. With the finalization of Rule 204, we have a chance to make meaningful progress on these deeply entrenched issues. Going beyond compliance is the best way for companies across the supply chain to pursue this. We envision a future where companies align together to provide end-to-end supply chain traceability.
The True Intent of Rule 204
iFoodDS believes the ultimate intent of FSMA Rule 204 is to create a fully transparent supply chain that ensures safer food for all. This kind of transparency comes from two core components:
- Having real-time food safety data available on-demand
- Having the capability to trace any item all the way through the supply chain, forward and backward (grower to retail/foodservice and vice versa)
Companies can’t afford to focus on their single link in the chain. The stakes are simply too high. Here are a few things to consider.
Lack of visibility could put you at risk
Doing the bare minimum to comply with Rule 204 could leave you vulnerable. Imagine if you keep paper records and then need to provide the FDA with an electronic sortable spreadsheet in 24 hours. Would your team be able to achieve this on such a tight deadline?
Now imagine a scenario where you only keep the records for your link in the supply chain but need to trace product back to the lot level. Do you want to find out your suppliers aren’t in compliance when it matters most – during an outbreak investigation? By ensuring full traceability across your suppliers, you’ll gain visibility into the entire supply chain. This not only shields you from many food safety risks but also helps you make better sourcing decisions, improving your supplier mix. Protect your brand and limit your recall exposure by embracing end-to-end traceability.
The Food Traceability List will likely grow
It makes sense to adopt detailed record keeping across all your products so you’re already prepared if more commodities are added to the Food Traceability List in the future. This also makes your processes more efficient and ensures consistency across all products.
You’ll gain a competitive advantage by embracing traceability
Consumers are demanding more transparency in the food they purchase. They want to know their food is safe, high-quality, and sustainable. One survey found that 71% of consumers feel traceability is important and would even pay a premium for traceable products.1
In response to growing consumer demands, buyers are raising the bar on their standards to protect their brand reputation. You can gain buyer preference over your competitors by going beyond compliance and enabling full supply chain transparency.
Is a Network Traceability Approach the Key?
The biggest obstacle to improving outbreak response has been the complexity of the supply chain. Even though the technology for full supply chain traceability exists, it’s virtually impossible to get every participant in the supply chain to agree on a single vendor. Interoperability is a necessary feature for any traceability solution.
A network approach may be the most efficient and effective way to bring the whole industry into compliance. In a network approach, the biggest players in the industry vet traceability solutions for their own supply chain partners and use their resources to assist with implementation. Smaller companies receive support, resources, and guidance as they navigate FSMA Rule 204 requirements. Large retailers, processors, manufacturers, distributors, and foodservice operators get an effective traceability solution to ensure compliance across their supplier network.
iFoodDS has developed a network traceability solution that benefits you as well as your network of suppliers. If you’re exploring options for traceability technology and would like to learn more, reach out to iFoodDS for a no-cost traceability consultation.
FDA Resource Links:
1. IBM, “Meet the 2020 consumers driving change,” 2020, https://www.ibm.com/downloads/cas/EXK4XKX8