Ask the Experts: FDA Compliance and the Role of Aptean EDI for Streamlining Food and Beverage Traceability

The clock is ticking—July 2028 marks the compliance date for the Food and Drug Administration’s (FDA) Traceability Final Rule under the Food Safety Modernization Act (FSMA). This critical milestone is fast approaching, and beyond costly legal penalties, non-compliance could damage brand reputation if you don’t take proactive actions in streamlining your company’s record-keeping processes.

Now is the time to prepare and integrate necessary solutions such as electronic data interchange (EDI) to help ensure your traceability practices are up to standard—so you can avoid hefty fines and maintain consumer trust.

In this interview, Aptean industry experts provide invaluable insights about the Food Traceability Final Rule and how Aptean EDI can help food and beverage organizations adhere to the new stringent regulations.

Industry Experts Tackle the New Regulation’s Impact and How Aptean EDI Can Facilitate Compliance

Drew Pogones, a seasoned professional with 18 years of experience in food and beverage manufacturing, brings deep expertise in regulatory compliance and navigating complex markets like FDA, USDA and TTB-regulated industries. In the conversation, Drew provides valuable insights into the impact of the FDA's traceability regulations under FSMA, emphasizing the importance of key data elements (KDEs) and critical tracking events (CTEs) in maintaining compliance.

Lindsey Wheeler, a dynamic force in Aptean’s EDI division, brings three years of specialized experience that have already made her a go-to expert for enhancing operational efficiencies. Known for her unmatched ability to streamline EDI processes, Lindsey ensures seamless integration and flawless data accuracy. Her deep understanding of customer needs, coupled with her drive to optimize EDI solutions, positions her as a trusted advisor—one who consistently delivers game-changing improvements in response times and operational outcomes, especially in the high-stakes world of food and beverage safety.

Q: How Do the New FDA Traceability Regulations Under the FSMA Impact the Food and Beverage Industry and Why Is Compliance Essential?

Drew Pogones (DP): FSMA has been active since 2011. We're dealing with the last rollout here, which is the food traceability rule.

One of the areas I really wanted to talk about is the new advancement of record-keeping requirements. Under these record-keeping requirements, there are some new acronyms we all have to learn to love. They are called KDEs, which are key data elements, and CTEs, which are critical tracking events. These are the detailed records that need to be updated at all times and passed throughout the supply chain—helping you comply with the new traceability standards. So, businesses now have to develop these and maintain a traceability plan to ensure that they can meet those requirements, consistently.

Another thing is the whole goal behind this push for the traceability plan. What this does is it increases supply chain visibility. We really need that transparency to allow for faster identification and trace back. The regulations are going to push for this transparency across the whole supply chain. They also want to make sure that manufacturers know their supply chains better—know who they're buying their products from, how to get in touch with them and their key contact information including address, phone number and email. Additionally, they’ll need a relationship where they can trust them as far as quality. Food manufacturers need to ensure they and their suppliers adhere to the same standards asking, "What are the standards that we are holding you to? Have you passed the GMP (good manufacturing process) audit? Where's the proof behind that?" and “If there's an issue, how do we get back to you as fast as possible?”

A significant area that's going to hit food manufacturers is the uptick in FDA inspections. Inherently, every time the FDA and USDA come up with a new regulation, that prompts inspections. They make the rules, give you a publication of what the rule is and give you time to go in and make sure your SOPs (standard operating procedures) match with that expectation. Then they'll give you a couple years of hand-to-hand communication to help educate while you regulate. I would expect an uptick in inspections, and every food and beverage manufacturer facility needs to be ready for that.

The other thing is there are possible technology upgrades that might be needed. This means companies may need to invest in technologies like EDI, RFID, maybe some IoT (Internet of Things) sensors and other tracking systems. Being able to have all these and integrate them will be a big push by the FDA here in the next 10 years.

Adhering to these new regulations is crucial for protecting public health. Businesses need to be able to respond quicker when food safety issues arise. This also helps companies avoid legal fees, costly recalls and most importantly, potential damage to reputation and brand. Staying compliant ensures companies can continue to operate without disruptions and maintain access to key markets domestically and internationally.

Q: What Are the Challenges That Food and Beverage Companies Face When Trying to Maintain Real-Time Accurate Traceability Across Their Supply Chain?

DP: When we take a look at the full supply chain, we also have to consider the varying sizes of each supplier. One may be a small business, one may be a large business, one may be doing business still on pen and paper and one may be all digital. This is something that companies need to keep in mind. We need to understand how we're going to extrapolate the information from beginning to end.

Another part of that is data integration issues. The way you pass that information from one chain to the next is another area that manufacturers are trying to solve. That's where these integrations are key. This is where an integration into an EDI and QMS (quality management system) is helpful—anything like that within your ERP will help you grab the information you need beforehand, when you make your product and when you hand it off to the next person in that supply chain.

Q: Why Are CTEs and KDEs Important for FDA Compliance?

DP: These are crucial when it comes to the new food traceability rule. Basically, the CTEs and KDEs are the foundation and the backbone of this food traceability rule. What they're doing is defining very specific points in the supply chain for each manufacturer where data needs to be captured and passed on. The goal is to ensure that every step of the finished good products' journey is traceable from production through distribution.

To give you a couple of examples of what KDEs and CTEs are, in case you're not familiar with them yet: KDEs are the things that our systems are already capturing, but our clients have to call out, "Hey, these are our KDEs, this is where we store them and this is how we have them readily available for not only an FDA audit but for anybody in the supply chain." Examples of KDEs include location IDs, product IDs, lot and batch numbers, quantities, unit of measurements, dates and times and source information, which is all your supplier information. These are the things we can capture in a centralized, real-time way with our ERP and EDI software.

CTEs, on the other hand, capture phases throughout the supply chain. This includes growing, receiving, transformation of products (like making one product into a different one, such as a salad kit), creating products, shipping and cooling. These are examples of CTEs. These are key acronyms to know, learn, live and love because they're the backbone of the food traceability rule. That's going to be the first thing the FDA asks you when they come in to inspect your facility.

Q: In What Ways Does Real-Time Visibility Into the Supply Chain Help Food and Beverage Companies Manage Safety Issues Like Product Recalls?

DP: Yes, real-time visibility is huge. Having real-time information is going to help you with many things throughout your day. One of the biggest things it's going to help with is recalls. It's going to help you identify any contaminated products, rapidly. As a manufacturer, if there’s an issue, the last thing you want is to not know where your products are. Real-time data will allow facilities to seamlessly trace the origin of contamination, be able to identify the exact batch, supplier or even a point in the supply chain where the issue occurred, and then lock that product down.

It also helps you target your recall. One of the biggest things is losing money, right? If you can't minimize the scope of the recall, instead of broad, costly recalls, facilities can now narrow it down to a product at a time, which will reduce waste and minimize financial losses.

From a quality point of view, real-time data gives you the chance to be proactive with risk management. Continuous monitoring can help detect potential food safety issues before they escalate, allowing you to correct the problem before having to put the product on hold. It can also help you halt production and implement a corrective and preventive action plan.

Real-time visibility also enhances collaboration within the supply chain. I preach this a lot with food manufacturing facilities. The supplier approval program itself is the most important thing you can do to have a good end product and make your logo stand out. You can't put garbage in and get quality out. You need to ensure that you're buying the best, you know the best and you trust the best. The best way to do that is to ensure they have real-time visibility to your stuff, and you have visibility to theirs. This helps with communication between suppliers, distributors and even regulators. They'll come in and say, "Alright, you know your suppliers very well. You have all the proof. You're good to go."

When you have this visibility and confidence throughout the supply chain, people are going to trust your product. They're not going to see you out there for recalls or food safety issues. It really protects your brand. If you know you can effectively manage a recall or any food safety incident, companies will trust that and be more willing to do business with you.

How Aptean EDI Facilitates FSMA Compliance and Operational Efficiency

Aptean EDI plays a crucial role in improving FSMA compliance and operational efficiency for food and beverage manufacturers. Lindsey Wheeler answered some key questions on how Aptean EDI can expedite response times in a recall scenario and offers practical steps for a smooth integration.

Q: Can You Describe a Scenario Where Aptean's Integrated EDI Would Significantly Improve Response Time to an FDA Inquiry or Emergency?

Lindsey Wheeler (LW): To piggyback off Drew’s mention of a recall scenario or public health outbreak, Aptean EDI would be critical in helping a food or beverage manufacturer improve their response time. Let's say there’s a product recall event. The information that we could pull from Aptean EDI include lot tracking information in the EDI advanced shipping notice (ASN/856) document. Food and beverage manufacturers could leverage this information to begin identifying which carriers shipped the contaminated product so that they can begin working to understand if proper storage protocols and shipping procedures were followed. Aptean EDI works in conjunction with the food safety functionality your food and beverage ERP provides to ensure that you have complete and accurate visibility into your supply chain.

Q: What Steps Should a Food and Beverage Business Take to Implement Aptean EDI to Enhance Compliance and Operational Efficiency?

LW: As a best practice, the first step you should take in tandem with exploring Aptean EDI would be to work on migrating your ERP system to the cloud. A cloud migration will ensure that your ERP will meet the minimum compatibility requirements for deploying Aptean EDI and provide you with the maximum amount of data security overall. As a secondary step in implementing Aptean EDI, I recommend reaching out to any suppliers and vendors you’re considering onboarding with Aptean EDI to ask them for the required EDI specs. The more information our team has in terms of trading partner requirements the smoother the EDI implementation will tend to go. Having access to all requirements allows us to ensure that mappings are set up correctly on the first go around, which saves you time and eliminates any potential trading partner non-compliance.

Aptean EDI Streamlines Traceability in Food and Beverage

Aptean EDI is a fully-managed solution that facilitates the seamless exchange of documents in a standard electronic format. It replaces error-prone and time-consuming, paper-based documents used by organizations in most transactions. The solution seamlessly integrates with Aptean’s industry-specific enterprise resource planning (ERP) systems such as Aptean Food & Beverage ERP.

Expanding food and beverage businesses integrate EDI to streamline connections with vendors, manufacturers, suppliers and retail customers. This seamless integration strengthens relationships with larger trading partners, helps ensure compliance with new regulations while opening doors to new markets and growth opportunities.

Aptean EDI Helps You Adhere With Regulatory Standards

With the FDA’s Traceability Final Rule compliance date on the horizon, it’s essential to consider how Aptean EDI can streamline your approach to meeting these new regulatory standards. Aptean EDI offers a practical solution for navigating complex regulatory requirements while improving your overall operational efficiency. This supports your efforts in maintaining compliance and optimizing traceability processes.

Integrating a fully-managed EDI goes beyond just meeting regulatory demands—it enhances your ability to manage supply chain operations effectively. By integrating this solution, you gain improved record-keeping capabilities, reduced errors and stronger connections across your supply chain. As you prepare for the new regulations, Aptean EDI serves as a valuable asset in ensuring smooth and efficient compliance.

Find out how Aptean’s fully-managed, integrated EDI can help ensure compliance, schedule your personalized demo today or get in touch with our team of EDI experts.