The produce industry is bracing for the implementation of the Food and Drug Administration’s (FDA) landmark Food Safety Modernization Act (FSMA) Section 204 traceability rule, and companies are taking divergent approaches to preparedness. While some organizations have forged ahead with robust implementation and testing programs, others remain in the early planning stages. FSMA represented the most significant overhaul of U.S. food safety law in more than 70 years, and Section 204 is one of its most consequential traceability rules.
Though the industry recognizes the benefits of effective traceability, aligning complex global supply chains remains a challenge. As a result, companies have launched a flurry of pilot projects and exploratory initiatives to help ensure a smooth transition to the new regulatory landscape.
The FDA proposed a 30-month extension in August 2025, pushing the compliance deadline from January 2026 to July 2028, and Congress subsequently directed the FDA not to enforce the Food Traceability Rule prior to that same date. The extension gives the industry more time to prepare in a coordinated and practical way. Because FSMA 204 requires data sharing across supply chain partners, many companies depend on upstream and downstream readiness to fully comply.
The added runway has enabled companies to pilot solutions, align expectations, and avoid rushed or fragmented implementation, says Wendy Logan, manager of supply chain and sustainability for the International Fresh Produce Association (IFPA), Washington, DC.
“Companies subject to FSMA 204 are actively preparing by reviewing their operations against the rule’s requirements and identifying where changes are needed,” she says. “Many have formed cross‑functional teams spanning food safety, IT, operations, and supply chain to assess readiness.”
System Needs
To support the requirements, companies are implementing a range of systems depending on scale and complexity. Smaller operations may rely on structured spreadsheets and manual data entry, while larger or more complex businesses are investing in electronic data collection tools, barcode labeling systems, warehouse management systems, and enterprise resource planning enhancements.
Readiness across the produce supply chain is mixed but progressing. It varies by company size, role in the supply chain and level of technology adoption, with some suppliers and buyers implementing foundational traceability practices, particularly those who have adopted Produce Traceability Initiative (PTI) best practices. IFPA recommends industry members who have not started with implementation start as soon as possible so they will have time to pilot their implementation process, Logan says.
While the compliance date, now a little over two years away, may seem like an adequate deadline for some, it isn’t for others, food safety authorities advise. Most companies that will need to comply with the rule have already taken deep dives into the requirements, and most have assessed the capabilities and gaps in their current systems and processes, says Jennifer McEntire, founder of Food Safety Strategy, LLC.
“It’s clear that the supply chain could not have been ready in January of 2026,” says McEntire. “Whether a formal extension of the deadline was needed, whether it needed to be 30 months, or whether enforcement discretion could have been used is debatable. But, there is no question that it was impossible for all covered entities to flip the compliance switch in January 2026.”
Before the rule, many Western Growers members had already invested in traceability systems. After the rule, they still had to make operational changes to capture all required Key Data Elements (KDEs), even if they were already capturing most of them. The efforts include investments in new systems, adjustments to existing systems, revisions of operational practices and company policies, as well as training employees in new procedures, systems upgrades or new systems, explains Sonia Salas, the Irvine, CA, organization’s associate vice president of food safety and regulatory affairs.
As companies prepare for the enforcement of the rule, many growers and shippers are reviewing and updating existing systems to ensure they can capture and maintain all required KDEs at the relevant Critical Tracking Events (CTEs). For growers who rely on paper-based records, preparation will likely require more significant changes, including evaluating internal processes and potentially adopting new tools or systems to organize the required data. In contrast, companies that previously implemented PTI are generally focused on adjusting to meet the new requirements, she says.
“Based on what we see, there are active efforts among downstream operations (retailers primarily) to be ready, but there is considerable work to do, as they manage multiple products and suppliers and continue to navigate and explore different ways to comply with the rule,” says Salas. “Differences in readiness across the supply chain may create challenges for early or proactive adopters if there is no alignment among trading partners.”
Some companies may be ready or closer to being ready, but they may also face the risk of additional or new demands from produce buyers who may not yet possess a clear framework or system in place, she says.
“This is why interoperability (systems being able to communicate with one another) and alignment across the supply chain are critical,” says Salas. “Pilot projects and coordinated approaches can help avoid duplication, unnecessary investments, and added costs, particularly when existing systems are not considered or leveraged.”
Grower-shippers may be better prepared than produce receivers. Many companies discovered their current systems get them part or most of the way there. Third-party software providers and/or upgrades to their current systems are being explored, points out McEntire.
Cost Factor
Costs associated with FSMA 204 implementation vary widely. Expenses may include labeling equipment, software upgrades, system integrations, training and process redesign.
“For some companies, particularly those already using traceability systems, incremental costs are modest,” says Logan. “For others, especially those starting from manual processes, upfront investments can be more significant.”
Given the flexibility the rule provides, the cost calculation remains difficult. Adoption shouldn’t be a heavy lift for some companies close to compliance, but it could be for others beginning the process, explains McEntire.
Major retailers, wholesalers and foodservice companies have started exploring ways they can comply with FDA requirements and, in most cases, exceed the rules in terms of the scope of what they’re requesting in data, says Randy Fields, chairman and chief executive of ReposiTrak, a Murray, UT, global food traceability and regulatory compliance network which connects food supply chain companies and wholesalers through an inventory management platform.
“We’re creating records at every level,” notes Fields. “So we know it can be done. At least the way we do it, the cost implication is probably not measurable. The big potential cost element here is if people can’t figure out a way to handle the product going through a distribution center, meaning they have to scan all the cases in, scan the cases out — that will be expensive.”
Save A Lot Food Stores has publicly commented on the rule. Strong traceability across the food supply chain is an important part of the discount grocer’s commitment to food safety and transparency in its nearly 700 stores across 29 states.
“FSMA 204 reinforces the importance of having clear, reliable data that allows products to be tracked throughout the supply chain, helping ensure issues can be identified and addressed quickly if they arise,” notes Mary Tegomoh, director of quality assurance for the Saint Ann, MO-based retailer. “At the same time, effective traceability depends on strong coordination between supply chain partners. From growers and manufacturers to distributors and retailers like us, each participant plays a critical role in capturing and sharing accurate information. When partners work together and align on how that data is exchanged, it helps create a more transparent and responsive food system that ultimately benefits retailers and consumers alike.”
Grower Experience
On the Food Traceability List (FTL) are numerous fruits and vegetables, including leafy greens, tomatoes, peppers, melons and fresh-cut items. While grapes aren’t on the list, some major retail customers still requested that grape supplier Pandol Bros. be compliant with the FSMA 204 traceability rule.
“It sounds like a lot of it involves some labeling to do with shipping, and electronic transfer of data that we already have,” observes Andrew Pandol, the Delano, CA, grower-shipper’s safety manager. “We know where on maps the crop is harvested, and it sounds like the rule is just taking all that information and passing it along to our retailers. So, our retailers will have all the traceability information of the product we’re selling to them, or at least the origin information of the product.”
With FSMA 204 initiatives, some of Pandol’s customers require labeling at the time of shipment and the electronic transfer of data — much of which Pandol was already collecting, he says.
“While we haven’t yet integrated all harvest locations into our ERP, they are available and, when fully implemented, we will be able to share comprehensive traceability information with our customers seamlessly,” says Pandol.
Pandol Bros.’ Enterprise Resource Planning (ERP) software system provider requires per-customer fees as well as ongoing fees to support the software that electronically transfers data to customers.
“It’s good that we are able to know where food comes from if there’s a problem,” says Pandol. “On the other hand, it’s super minimal cost, but it’s expensive. I see the value of it, but it’s almost like the reverse of buying a lottery ticket. You’re buying a little traceability insurance, but there’s such a low possibility that sometimes these costs are hard to justify.”
When there’s an issue, the priority is finding the source immediately, he says. “We’re confident in our current traceability and do regular testing, but more collaborators only strengthen that safety net,” notes Pandol. “However, there is the reality of the added expense and the resources required to maintain it.”
For early adopters, many growers describe preparation as a learning process that requires close coordination with packers, shippers and buyers. While initially complex, the process became more manageable once requirements were clearly mapped to daily operations.
“Start now, even if systems are not perfect,” advises IFPA’s Logan. “Focus on understanding your role, documenting processes, communicating openly with trading partners and piloting your implementation plan. Small steps taken early can prevent larger challenges later. FSMA 204 compliance is not a single event, but an ongoing process.”
Any advantage gained by early adopters, which would have been two years ago, lies in the quality and accuracy of the data originating from suppliers. “Traceability begins with the supplier,” says Fields. “Most people just ship data. If you’re naive and you get the data and you don’t have a way of detecting the errors, you just accept it as truth and then you run that through your systems.
“We found that most suppliers, when they first get started with traceability, have error rates in the 40 to 60% range. It’s the learning curve. When you are amongst the people who can do it, you find that there’s value in the data way beyond traceability. There are operational implications, expiration dates, quantity shift, ordering and supply chain.”
The supply side of the industry is in some ways farther ahead than the buying side, notes Food Safety Strategy’s McEntire. However, outbreak investigations start at the buying side, looking into what people ate and where they ate or purchased the food, then move back to find that common grower or processor. “As an individual company, saying ‘I have great traceability’ is not enough if there are kinks in the supply chain,” says McEntire.
Lack of ERP Consistency
For effective traceability systems, all parties across the supply chain must synchronize and comply. At the start of the supply chain, grower-shippers play a critical role in capturing KDEs.
However, if that information is not accurately and efficiently tracked and transferred by other entities (including brokers, distributors and retailers), the value of traceability is diminished and the system cannot achieve its intended purpose, says Western Growers’ Salas.
“For companies in the produce industry that already had traceability systems in place through the Produce Traceability Initiative, the extension did not make a significant difference,” she says. “The ongoing challenge continues to be alignment across the supply chain and the presence of diverse approaches among trading partners. Additional time may help support better alignment.”
However, data compatibility among service providers isn’t uniform. “Every one of the receivers says, ‘I want you to send me the information I need for traceability like this.’ ‘And send me that stuff as well.’ So, in other words, there’s no homogeneity of what people are asking for, and therefore no capability to do it,” says Fields.
“Interoperability is a pipe dream. The reason is that there are too many different systems that have data in too many different ways. And 70% or 80% of the suppliers have no IT department. So how are they going to figure out how to homogenize data? They can barely get out of their systems.”
Service providers need to up their game as well. “Service providers shouldn’t be deluded into thinking that their system alone will be the sole provider to the industry,” says McEntire. “The best thing service providers can do to support the industry is demonstrate interoperability with other systems.”
Efficient traceability is dependent on coordination between supply chain partners and receivers. McEntire uses a telephone system analogy to portray the chaos that could arise with different systems: Imagine if callers were required to carry 10 different phones — different combinations of hardware and service providers — with the callers’ combination needed to match who they were calling.
“Today, the supply chain has not aligned on how to communicate with each other, and this will challenge the process,” says McEntire. Service providers can support the industry by working together and avoiding multiple or unnecessary investments by individual companies.
As Salas explains, “This can be challenging, as service providers may focus more on promoting their own platforms than on ensuring interoperability across systems, that is, enabling different platforms to communicate with each other. Coordination, alignment and interoperability are critical for the system to work.”
The rule represents a missed opportunity to standardize a set of options to collect digitized cold chain control data at all scales of production, which could prevent illness and outbreaks by achieving a broader and deeper database for AI-assisted analytics, observes Trevor Suslow, professor of applied research and extension emeritus of the UC Davis Department of Plant Sciences.
“It is always counterintuitive to provide exemptions in traceability for small producers and ‘stealth’ produce items on the FTL, which may complicate rapid identification of food vehicles in outbreak traceback and trace forward epidemiology and investigations,” he explains.
“Direct farm to end user off-ramp exemption, if ‘packaged on the farm,’ has the potential to be misunderstood by some growers and their contracting shippers or buyers unaware of the FDA definition of allowed packaging.
“Direct farm to end-user packaging and packing for distribution typically/rarely meet the FDA definition intended to prevent contamination potential during off-farm handling.”
The clock is ticking for produce firms to navigate a complex web of operational, technological and regulatory hurdles to bring the industry’s traceability systems into the 21st century.