(Trace)back to the Future

In the animated television show Futurama, there is a scene in which aliens, attempting a hostile takeover of Planet Express, exhort Professor Farnsworth to aid them by working, “Faster, faster!” Under duress of laser gunpoint, Farnsworth furiously keys in data on his computer, exclaiming, “I’m sciencing as fast as I can!” While there is still more than two years left for certain food industry players to come into compliance with the U.S. Food and Drug Administration’s (FDA) final Food Traceability Rule (FTR), the nearly 600-page document is so complex that many experts are urging food supply chain stakeholders to get planning as fast as they can.

The final rule, which implements Section 204(d) of the FDA Food Safety Modernization Act (FSMA), is designed to reduce the incidence of foodborne illnesses by instituting additional traceability recordkeeping requirements for high-risk foods. The rule, which carries a compliance deadline of January 20, 2026, applies to manufacturers, processors, packers, and entities that hold foods and multicomponent products containing foods specified on the Food Traceability List (FTL). The list includes soft and semi-soft cheeses, shell eggs, leafy greens, shellfish, crustaceans, ready-to-eat deli salads, and fresh and fresh-cut fruits and vegetables. To achieve faster identification and removal of potentially contaminated food from the market, the FTR mandates those on the FTL to take several steps, including using FDA-designated Critical Tracking Events (CTEs) as points in the supply chain from which to gather Key Data Elements (KDEs) for recordkeeping, assigning traceability lot codes (TLCs), and establishing a traceability plan.

Although the FTR, also dubbed FSMA Section 204, applies only to FTL listed foods, FDA has signaled that it will use the rule as a foundation to encourage the entire food industry to adopt end-to-end traceability as part of the agency’s New Era of Smarter Food Safety Initiative. To do that, FDA is working to construct financial models that will support food companies, no matter the size, to achieve full, scalable, and cost-effective traceability through tech-enabled trace-and-track solutions. For example, in 2021, the agency launched its Low- or No-Cost Tech-Enabled Traceability Challenge, which invited technology providers, public health advocates, and innovators from all disciplines to develop traceability hardware, software, or data analytics platforms that are low-cost or no-cost to the end user. Of the 90 participants, 12 were named Challenge winners the following September, touting technologies ranging from batch-tracking and cloud-based software, to geospatial, machine learning, and Internet of Things (IoT) technologies, to blockchain platform tools.

Even so, as Professor Farnsworth might say, there is still a lot of “sciencing” to do—and quickly—to resolve some of the immediate challenges of identifying and implementing tech-enabled traceability technologies by the January 2026 compliance date.

Tech Challenges

In May, the Institute of Food Technologists (IFT) released a report commissioned by FDA that evaluates food traceability trends based on submissions from participants in FDA’s 2021 Low- or No-Cost Tech-Enabled Traceability Challenge. The independent report analyzes recent technological hardware, software, and data analytics developments for traceability end users. IFT determined that the knowledge, means, and technology have been developed to make end-to-end tech-enabled traceability a reality, but it will not be realized without collective action and continued innovation among the diverse food industry community.

Blake Harris, technical director of IFT’s Global Food Traceability Center (GFTC), says that the potential challenges related to tech-enabled traceability solutions revolve around interoperability, support and infrastructure, operation size/capability, usability, and cost. One of the biggest considerations for industry outlined in the report is a current lack of interoperability between supply-chain partners, he notes, especially since the FTR does not standardize or prescribe what technologies to use.

“In the rule, FDA has provided a good starting foundation by defining the data points that industry needs to track, collect, and keep records on, but there is no data standard around interoperability, which is basically how that data is collected and formatted for everyone, and how that data is communicated between software products,” Harris says. “Our report insights showed that there is a need for broad stakeholder engagement in order to create these data standards and move towards interoperability to really make a positive impact on the traceability landscape.”

Report coauthor Sara Bratager, IFT food traceability and food safety scientist, notes that infrastructure and usability also present practical challenges for food companies working to incorporate tech-enabled traceability technologies into their programs.

“Our food systems were built to move products, but they were not necessarily built to move data. [Food companies] don’t want to have to change operational processes, so they’re always looking for digital systems that are going to work with their existing operations,” Bratager explains. “[So], trying to identify a system that’s going to work as closely as possible with the processes that you’ve already got in place is very difficult and may seem like an impossible task for some, especially smaller- or even medium-sized operations.”

In addition, Bratager notes that food companies and their supply chain partners will need to consider potentially challenging environments in which tech-enabled traceability solutions are deployed. For example, processing located in concrete buildings that are typically wet and cold may be inhospitable for some IoT devices used to collect data, such as tablets or cell phones. Similarly, if data collection is expected to take place on the farm at the point of harvest, producers that are not equipped with Wi-Fi will face challenges collecting and transmitting vital data.

“So, finding the technology that works with the infrastructure you’ve got, or having to build that infrastructure so that you can host the technology that you need to collect and share data is a huge challenge,” Bratager says.

Global food lawyer Melanie Neumann, founder of Neumann Advisory Services, whose experience includes in-house counsel positions with Hormel Foods and The Schwan Co., adds that she anticipates some specific challenges in the initial application of the FTR’s traceability lot code requirement and the circumstances under which it may be changed. She notes that it is current industry practice for facilities to change the lot code from its suppliers to one its own system recognizes.

“Under the new rule, facilities will need to honor the previously applied TLC unless certain criteria exist that allow it to change the TLC,” Neumann says. “This is a challenge because there are numerous and disparate traceability systems in use today, many of which are ‘home-grown,’ meaning internally developed by the food company. Hence, harmonizing systems across the supply chain by 2026 seems to be a rather high hurdle to leap.”

A Universe of Opportunity

Even with these challenges, there are some important benefits of advancing tech-enabled traceability solutions for the entire food industry, not just the supply chain stakeholders on the FTL, Bratager says. First and foremost is the opportunity to improve outbreak responses and execute faster recalls afforded by utilizing traceability technologies. “Because that’s what the traceability rule was created for,” Bratager explains. “There’s a lot of other benefits to traceability, but this rule is specifically designed to reduce the time it takes to have a recall, a withdrawal, or any kind of traceback event and get more accurate data [as a result], so that’s going to be the biggest benefit.”

Bratager also notes that companies that are successful in implementing effective tech-enabled traceability will be able to use that traceability data to assure other food safety outcomes, as well. “The more data that you have on your customers, the more visibility you’ve got in your supply chain, and the more opportunities you have to make improvements. These technologies enable you to have better supply chain management, better tracking of customer and consumer complaints, and better insight into food safety issues,” she says. “Then, you can start to consider, ‘Okay, who’s having these issues in my supply chain, where are the issues happening, what are the weak points, and what kind of preventative measures can I take to keep those from happening in the future?’”

Attorney Neumann agrees, noting that in addition to expediting traceback investigations to determine the root source of a recall or outbreak, achieving the traceability outcomes envisioned by the FTR provides food facilities with the documented evidence to demonstrate whether they played a role in or caused  the event, which can help the facility in a legal or contract-law situation. “For example, maintaining robust traceability records will help facilities determine if an issue was supplier-caused, and hence, aid in a request for indemnification for losses caused by the supplier’s error,” Neumann says.

Preparing for Launch

At the end of the day, getting your food operation into tech-enabled traceability mode in time to meet the FTR deadline of January 20, 2026, is going to take resourceful, focused, and advance planning. And that planning needs to start now, suggests Neumann.

“Implement your solution well in advance, allowing time for troubleshooting and pressure testing to ensure your tech-enabled traceability enhancements can actually answer the compliance call,” she says. “I recommend that project completion or go-live dates be set for at least six months prior to the compliance date to allow sufficient time to resolve any last-minute issues.”

Bratager agrees, noting that getting started on an implementation strategy right away is excellent advice, given the timeframe for compliance. “The best advice I can give is to say get started now, because this is by no means an impossible effort,” she explains. “It’s doable to achieve compliance, but it’s going to be time-sensitive because implementation takes time, identifying technology takes time, and training people takes time. To be successful, companies cannot wait until six months prior to the deadline to consider how they will comply.”

A good first step toward making a tech-enabled traceability system a reality is to gain support and buy-in from company leadership, adds Harris. “It’s crucial that leadership not only understand the implications of noncompliance with this rule, but also the reality of both the investment that needs to be made and the work that needs to get done to comply with this rule.”

After achieving buy-in, companies can begin talking with technology providers to ascertain whether they have the capabilities needed to help facilitate compliance with the FTR and reflect costs inherent to implementing, scaling, and maintaining tech-enabled traceability systems. “With regard to an individual company’s consideration for investment in traceability software, the fact is that not necessarily everybody needs to get a blockchain-based system,” Harris advises. “Get a system that works for your specific operation. And ask potential technology solution providers whether they follow any existing data standards, because there are some out there that are widely used and having that conversation with solution providers ensures that everyone is pushing in the same direction.”

For companies on the FTL, IFT’s traceability experts also recommend taking a two-pronged approach to gathering information and planning for implementation. First, food companies and their supply chain partners should engage with their communities through their commodity-specific or trade associations, whether by participating in relevant FTR-focused working groups, working with peers to develop category-specific guidelines, or sharing best practices. Doing so, says Bratager, gets everyone in a specific supply chain on the same page toward a common goal.

“If everyone has a slightly different process, then you’re going to have to translate what each partner is doing as you go down the supply chain, and that gets costly and complex,” she explains. “But if you’ve got everyone rallied around, ‘Okay, here’s the process, here’s the data we’re going to collect, here’s how we’re going to format that data, and here’s how we’re going to communicate that data, and we’re all going to do it the same way,’ it reduces cost and complexity.”

The second prong involves seeking out authoritative educational resources to learn more about the FTR and how it will impact specific companies and supply chain nodes. IFT, which offers commodity-specific videos that cover the key sections of the FTR for each of the foods listed on FDA’s Food Traceability List, webinars, a white paper, and other tools and training modules, is a good example of this type of resource, say Harris and Bratager, who suggest that food companies looking for traceability technology solutions, particularly those on the FTL, review IFT’s Low- or No-Cost Traceability report.

“[The report] gives a good overview of what’s available in the field of traceability solutions right now,” Bratager says, “and provides guidance on what to consider when you are evaluating or purchasing a traceability solution. It looks at cost considerations beyond the sticker price, including factors that you want to think about before you choose to invest in technology. That should be very helpful for supply chain actors working to move their systems from paper to digital.”

TO LEARN MORE

To download a copy of IFT’s Tech-Enabled Traceability Insights Report please visit content.ift.org/traceability