Ever wondered where that apple or deli salad you’re noshing on came from (and where it’s been)? We may soon have more clarity on questions like these, thanks to a new federal regulation known as FSMA 204.
Ben Ames has spent 20 years as a journalist since starting out as a daily newspaper reporter in Pennsylvania in 1995. From 1999 forward, he has focused on business and technology reporting for a number of trade journals, beginning when he joined Design News and Modern Materials Handling magazines. Ames is author of the trail guide "Hiking Massachusetts" and is a graduate of the Columbia School of Journalism.
The next time you pick up a snack—say, an apple or a jar of almond butter—at a local store, take a moment to see if you can figure out where that item was grown or produced. If you’re in a supermarket, you might glance at the label, but that often just tells you the name of the distributor. Bar codes aren’t much help either—they typically provide little more information than the item’s price or SKU (stock-keeping unit) number.
But just over two years from now, the picture will be much clearer—at least for players in the food supply chain—thanks to a federal regulation known as FSMA 204. FSMA 204, which stands for Section 204 of the U.S. Food and Drug Administration (FDA) Food Safety Modernization Act, establishes new, tightened traceability recordkeeping requirements for “persons who manufacture, process, pack, or hold foods included on the [agency’s] Food Traceability List”—a roster that includes many fresh fruits and vegetables, a variety of soft cheeses, shell eggs, nut butter, herbs, some categories of seafood, and refrigerated and ready-to-eat deli salads.
The FDA’s goal is to better protect the public from foodborne diseases by strengthening the food tracking system from farm to retailer, according to a white paper from Wiliot, an Illinois-based provider of cloud services and internet of things (IoT) technologies. The end goal is a stronger tracking system that will allow for faster identification and rapid removal of potentially contaminated food from the market, the FDA says on its website.
THE NUTS AND BOLTS
Though it’s part of a much broader food safety initiative, FSMA 204 at its core is simply about recordkeeping—recordkeeping by every entity that participates in the “harvesting, packing, and transportation of foods covered by Section 204,” according to the Wiliot white paper. That includes commercial farms, packing operations, and food processing facilities as well as a host of logistics-sector players. While carriers are exempt from FSMA 204, warehouses, food suppliers, wholesalers/distributors, grocery and convenience stores, and retail food establishments of all stripes come under the new rule’s purview.
As for the records themselves, parties subject to the rule must “maintain records containing key data elements (KDEs) associated with specific critical tracking events (CTEs) in the food handling process,” according to the FDA’s website. Examples of CTEs include harvesting, cooling, initial packing, shipping, and receiving. KDEs vary according to the CTE, but in the case of harvesting, for instance, the data elements would include the location of the farm (or even field) and date of harvest. Each affected company must store all of that information for 24 months. And if an outbreak of foodborne illness occurs, the company must be able to share all of it with federal regulators on 24 hours’ notice.
What makes this all the more complicated is that these companies must be able to share the data not just with the FDA, but also with suppliers, wholesalers, distributors, stores, and restaurants.
“Historically, the industry was only required to track where product came from and directly where it was shipped. That’s all changed with FSMA 204,” Brian Piancino, COO of Texas-based wholesaler Affiliated Foods Inc., said in a release describing his company’s response to the new requirements. “Now everyone from the grower in the field, to the processor, to the warehouse must have electronic data tracking in place and the ability to provide that data to the next person in line in the supply chain all the way to the backroom of the retail store.”
The FDA doesn’t dictate the type of technology required for compliance, but Wiliot says any company looking to meet the new requirements will almost certainly have to use automatic identification(auto ID) technologies such as smart tags and IoT sensors, all linked to interoperable online databases, to avoid incurring huge increases in labor costs.
NO TIME TO WASTE
The new traceability regulations took effect on Jan. 20 of this year, but the FDA has set a three-year grace period for adopting new processes, so enforcement begins on Jan. 20, 2026. While that might sound like a lot of breathing room, experts say it’s actually a pretty aggressive timeline for an IT project of this scope.
“That leaves only [28] months for an estimated 1.5 million-plus grocery stores, restaurants, convenience stores, and the entire supply chains of the products on the Food Traceability List to get traceability processes and traceability data management and recordkeeping systems in place,” says Derek Hannum, chief customer officer for ReposiTrak, a provider of supply chain risk mitigation and compliance management solutions. “In short, there is an enormous amount of work to get done and not very much time to do it.”
According to Hannum, the protocols needed to comply with the new traceability requirements will be a big step up from current recordkeeping practices, like the common “one forward/one back” approach, where each company keeps its own records on who it receives product from and who it ships product to. A big part of the challenge will be finding ways to share detailed information swiftly with so many other parties.
“It’s the sharing of the data between suppliers, wholesalers, distributors, stores, and restaurants that is new, and virtually no one has systems or processes in place today to make this data-sharing easy and routine in the complex network of players that comprise the U.S. food supply chain,” Hannum says.
Savanna Holt, a transportation manager with supply chain consulting and technology services firm enVista, agrees. “Based on [what we’re seeing with] the clients, organizations, and other industry stakeholders we’ve been working with, [almost] no one is compliant with FSMA 204 standards yet,” she says. “The majority of the industry is still in the initial stages of trying to wrap their heads around FSMA 204’s requirements and determine what best practices are for compliance.”
The chief hurdle is that the new rule requires a far more granular level of data tracking than current practices like one step forward/one step back, Holt says. Complying with the new standards will likely require significant technology investments, a burden that will probably fall most heavily on the parties closest to consumers. “FSMA 204 is not the first FSMA ruling. Previous rulings were more focused on suppliers, so they would likely already have more practices in place for becoming compliant with this new ruling,” Holt says. “Because of this, FSMA 204 is impacting those toward the middle and end of the supply chain, like distributors and[retailers], the most.”
FOCUS ON THE TECHNOLOGY
That’s not to say everybody has yet to leave the starting gate. Some companies, like Affiliated Foods Inc., are well underway on their compliance journey. Affiliated, which serves more than 800 member stores across the Southwest, recently adopted the ReposiTrak Traceability Network, an online portal that enables its suppliers to exchange the “key data element” information required by the FDA for every critical tracking event in the food handling process.
But Affiliated may be more the exception than the rule. As the enforcement deadline draws near, many players in the food supply chain will have to significantly up their tracking game, which will likely mean investing in more robust auto ID, IoT, and other data-management and -sharing technologies.
For those starting out on their journey, ReposiTrak’s Hannum offers a word to the wise. For all its complexities, he says, FSMA 204 compliance is fundamentally an IT matter—and organizations should approach it that way.
“As more companies start to realize that FSMA 204 traceability is not actually a food safety project, but rather a supply chain data management project, they can then begin to mobilize the people and resources required for compliance,” he says.
For the past seven years, third-party service provider ODW Logistics has provided logistics support for the Pelotonia Ride Weekend, a campaign to raise funds for cancer research at The Ohio State University’s Comprehensive Cancer Center–Arthur G. James Cancer Hospital and Richard J. Solove Research Institute. As in the past, ODW provided inventory management services and transportation for the riders’ bicycles at this year’s event. In all, some 7,000 riders and 3,000 volunteers participated in the ride weekend.
Photo courtesy of Dematic
For the past four years, automated solutions provider Dematic has helped support students pursuing careers in the STEM (science, technology, engineering, and mathematics) fields with its FIRST Scholarship program, conducted in partnership with the corporate nonprofit FIRST (For Inspiration and Recognition of Science and Technology). This year’s scholarship recipients include Aman Amjad of Brookfield, Wisconsin, and Lily Hoopes of Bonney Lake, Washington, who were each awarded $5,000 to support their post-secondary education. Dematic also awarded $1,000 scholarships to another 10 students.
Motive, an artificial intelligence (AI)-powered integrated operations platform, has launched an initiative with PGA Tour pro Jason Day to support the Navy SEAL Foundation (NSF). For every birdie Day makes on tour, Motive will make a contribution to the NSF, which provides support for warriors, veterans, and their families. Fans can contribute to the mission by purchasing a Jason Day Tour Edition hat at https://malbongolf.com/products/m-9189-blk-wht-black-motive-rope-hat.
MTS Logistics Inc., a New York-based freight forwarding and logistics company, raised more than $120,000 for autism awareness and acceptance at its 14th annual Bike Tour with MTS for Autism. All proceeds from the June event were donated to New Jersey-based nonprofit Spectrum Works, which provides job training and opportunities for young adults with autism.
The logistics process automation provider Vanderlande has agreed to acquire Siemens Logistics for $325 million, saying its specialty in providing value-added baggage and cargo handling and digital solutions for airport operations will complement Netherlands-based Vanderlande’s business in the warehousing, airports, and parcel sectors.
According to Vanderlande, the global logistics landscape is undergoing significant change, with increasing demand for efficient, automated systems. Vanderlande, which has a strong presence in airport logistics, said it recognizes the evolving trends in the sector and sees tremendous potential for sustained growth. With passenger travel on the rise and airports investing heavily in modernization, the long-term market outlook for airport automation is highly positive.
To meet that growing demand, the proposed transaction will significantly enhance customer value by providing accelerated access to advanced technologies, improving global presence for better local service, and creating further customer value through synergies in technology development, Vanderlande said.
In a statement, Nuremberg, Germany-based Siemens Logistics said that merging with Vanderlande would “have no operational impact on ongoing or new projects,” but that it would offer its current customers and employees significant development and value-add potential.
"As a distinguished provider of solutions for airport logistics, Siemens Logistics enjoys a first-class reputation in the baggage and air-cargo handling areas. Together with Vanderlande and our committed global teams, we look forward to bringing fresh impetus to the airport industry and to supporting our customers' business with future-oriented technologies," Michael Schneider, CEO of Siemens Logistics, said in a release.
The initiative is the culmination of the companies’ close working relationship for the past five years and represents their unified strength. “We recognized that going to market under a cadre of names was not helping our customers understand our complete turn-key services and approach,” Scott Lee, CEO of Systems in Motion, said in a release. “Operating as one voice, and one company, Systems in Motion will move forward to continue offering superior industrial automation.”
Systems in Motion provides material handling systems for warehousing, fulfillment, distribution, and manufacturing companies. The firm plans to complete a rebranded web site in January of 2025.
I recently came across a report showing that 86% of CEOs around the world see resiliency problems in their supply chains, and that business leaders are spending more time than ever tackling supply chain-related challenges. Initially I was surprised, thinking that the lessons learned from the Covid-19 pandemic surely prepared industry leaders for just about anything, helping to bake risk and resiliency planning into corporate strategies for companies of all sizes.
But then I thought about the growing number of issues that can affect supply chains today—more frequent severe weather events, accelerating cybersecurity threats, and the tangle of emerging demands and regulations around decarbonization, to name just a few. The level of potential problems seems to be increasing at lightning speed, making it difficult, if not impossible, to plan for every imaginable scenario.
What is it Mike Tyson said? Everyone has a plan until they get punched in the mouth.
It has never been more important to be able to pivot and adjust to challenges that can throw you off your game. The report I referenced—the “2024 Supply Chain Barometer” from procurement, supply chain, and sustainability consulting firm Proxima—makes the case for just that. The company surveyed 3,000 CEOs from the United Kingdom, Europe, and the United States and found that the growing complexities in global supply chains necessitate a laser-sharp focus on this area of the business. One example: Rightshoring, which is the process of moving business operations to the best location, means companies are redesigning and reconfiguring their supply chains like never before. The study found that large numbers of CEOs are grappling with the various subsets of rightshoring: 44% said they are planning to or have already undertaken onshoring, for instance; 41% said they are planning to or have undertaken nearshoring; 41% said they are planning to or have undertaken friendshoring; and 35% said they are planning to or have undertaken offshoring.
But that’s not all. CEOs are also struggling to deal with the rise of artificial intelligence (AI) and its application to business processes, the potential for abuse and labor rights issues in their supply chains, and a growing number of barriers to their companies’ decarbonization efforts. For instance:
Nearly all of those surveyed (99%) said they are either using or considering the use of AI in their supply chains, with 82% saying they are planning new initiatives this year;
More than 60% said they are concerned about the potential for human or labor rights issues in their supply chains;
And virtually all (99%) said they face barriers to decarbonization, with 30% pointing to the complexity of the work required as the biggest barrier.
Those are big issues to contend with, so it’s no surprise that 96% of the CEOs Proxima surveyed said they are dedicating equal (41%) or more time (55%) to supply chain issues this year than last year. And changing economic conditions are adding to the complexity, according to the report.
“As inflation fell throughout last year, there were glimmers of markets stabilizing,” the authors wrote. “The reality, though, has been that global market dynamics are shifting. With no clear-set position for them to land in, CEOs must continue to navigate their organizations through an ever-changing landscape. Just 4% of CEOs foresee the amount of time spent on supply chain-related topics decreasing in the year ahead.”
Simon Geale, executive vice president and chief procurement officer at Proxima, added some perspective.
“It’s fair to say that the complexities of global supply chains continue to have CEOs around the world scratching their heads,” he wrote. “The results of this year’s Barometer show that business leaders are spending more and more time tackling supply chain challenges, reflecting the multiple challenges to address.”
Perhaps the extra focus on supply chain issues will help organizations improve their ability to roll with the punches and overcome resiliency challenges in the year ahead. Only time will tell.
Investing in artificial intelligence (AI) is a top priority for supply chain leaders as they develop their organization’s technology roadmap, according to data from research and consulting firm Gartner.
AI—including machine learning—and Generative AI (GenAI) ranked as the top two priorities for digital supply chain investments globally among more than 400 supply chain leaders surveyed earlier this year. But key differences apply regionally and by job responsibility, according to the research.
Twenty percent of the survey’s respondents said they are prioritizing investments in traditional AI—which analyzes data, identifies patterns, and makes predictions. Virtual assistants like Siri and Alexa are common examples. Slightly less (17%) said they are prioritizing investments in GenAI, which takes the process a step further by learning patterns and using them to generate text, images, and so forth. OpenAI’s ChatGPT is the most common example.
Despite that overall focus, AI lagged as a priority in Western Europe, where connected industry objectives remain paramount, according to Gartner. The survey also found that business-led roles are much less enthusiastic than their IT counterparts when it comes to prioritizing the technology.
“While enthusiasm for both traditional AI and GenAI remain high on an absolute level within supply chain, the prioritization varies greatly between different roles, geographies, and industries,” Michael Dominy, VP analyst in Gartner’s Supply Chain practice, said in a statement announcing the survey results. “European respondents were more likely to prioritize technologies that align with Industry 4.0 objectives, such as smart manufacturing. In addition to region differences, certain industries prioritize specific use cases, such as robotics or machine learning, which are currently viewed as more pragmatic investments than GenAI.”
The survey also found that:
Twenty-six percent of North American respondents identified AI, including machine learning, as their top priority, compared to 14% of Western Europeans.
Fourteen percent of Western European respondents identified robots in manufacturing as their top choice compared to just 1% of North American respondents.
Geographical variances generally correlated with industry-specific priorities; regions with a higher proportion of manufacturing respondents were less likely to select AI or GenAI as a top digital priority.
Digging deeper into job responsibilities, just 12% of respondents with business-focused roles indicated GenAI as a top priority, compared to 28% of IT roles. The data may indicate that GenAI use cases are perceived as less tangible and directly tied to core supply chain processes, according to Gartner.
“Business-led roles are traditionally more comfortable with prioritizing established technologies, and the survey data suggests that these business-led roles still question whether GenAI can deliver an adequate return on investment,” said Dominy. “However, multiple industries including retail, industrial manufacturers and high-tech manufacturers have already made GenAI their top investment priority.”