Keeping food safe by improving traceability is high on the agenda of government and industry groups for 2020. The reasons why likely come as no surprise: It took health officials six weeks to trace the source of an E. coli outbreak in romaine lettuce in 2018. Some outbreaks, like the 2019 one involving blackberries, are difficult to trace because a distribution center may not keep records of where its various fruit shipments originate. Additionally, some outbreaks simply can’t be traced.
Two initiatives by FDA this year aim to improve traceability. One, the “New Era of Smarter Food Safety Blueprint,” is expected to be rolled out in the first quarter and includes recommendations for using digital technology to improve traceability and food safety. The other initiative would create a list of high-risk foods, along with additional recordkeeping for those foods, by September, with a final rule due by November 2022. Both initiatives fall under the Food Safety Modernization Act (FSMA).
Industry experts see the increased focus on traceability as a way of moving from merely tracking an outbreak to potentially preempting a crisis by bringing technology to bear in both recording data and then analyzing it efficiently and effectively. “This is going to be the biggest year for traceability in a very long time. It will be one of those landmark years,” says Dr. Jennifer McEntire, PhD, vice president of food safety and technology at the United Fresh Produce Association, an industry group in Washington, D.C. “If you can’t get to the source of the problem, it will continue to happen.”
Tejas Bhatt, senior director of food safety innovations at Walmart in Bentonville, Ark., agrees. “Traditional traceability is viewed as a reactive tool used after the problem has occurred,” he says. “It can [also] be a preventive tool, to prevent an outbreak. Technology is one thing that’s missing.”
And the complexity of tracing foods today is something FDA recognizes. In a statement last April on the Smarter Food Safety initiative, acting FDA Commissioner Ned Sharpless, MD, and Deputy Commissioner Frank Yiannas, said, “Today’s technology-focused world has morphed the way our society operates, creating a highly complex and globally interconnected landscape that is fundamentally changing the way foods move from farm to table. We’ve evolved from a system that sources foods from ‘around the corner’ to ‘around the world’ and are now redefining the ‘last mile’ with the emergence of various direct-to-home food delivery models.”
In addition to genetics tools already in use, FDA is expected to leverage emerging technologies, including distributed ledgers, sensors, the Internet of Things, and artificial intelligence to improve food safety.
The main areas FDA is focusing on include:
1. Technology-enabled traceability and foodborne outbreak response. This initiative will examine technologies, data streams, and processes to reduce the time it takes to track and trace the origin of a contaminated food and respond to public health risks.
2. Smarter tools and prevention approaches. The goal is to enhance the use of new knowledge from traceback, data streams, and tools for rapidly analyzing data. Using new data analysis tools and predictive analytics will help FDA and stakeholders better identify and mitigate potential food safety risks and advance the preventive controls framework that FSMA established.
3. Adapting to new business models and retail food safety modernization. This initiative will focus on advancing the safety of both new business models, such as e-commerce and home delivery of foods, and traditional business models, including retail food establishments.
4. Food safety culture. FDA wants to promote and recognize the role of food safety culture in farms and facilities. This will involve doing more to influence what employees and companies think about food safety and how they demonstrate a commitment to this work. FDA also is working to educate consumers on safe food handling practices.
“We will assess how these technologies could create a more digital, transparent, and safer food system while also addressing consumer demands for quick access to information about where their foods come from, how they’re produced, and if the food is the subject of an ongoing recall,” the commissioners said in their statement.
Bryan Hitchcock, senior director of Food Chain and executive director of the Institute of Food Technologists’ Global Food Traceability Center in Chicago, says he’s already seeing consumer preferences drive some of the new traceability goals. “We’re seeing a lot more interest and awareness by consumers of how food is manufactured, its traceability, and chain of custody,” he says. “There’s a disruption in the distribution channels in how food is delivered and consumed. Sometimes delivery is by bicycle. This is all causing people to rethink supply chains.”
Learning From the Past
Before producers, distributors, and retailers can move too far ahead with technology, issues that are holding back progress must be addressed. Those include many parts of the supply chain still using paper records and other parts simply not inputting data that would be useful during recalls.
Dr. McEntire says that the Produce Traceability Initiative has been in use for a decade, but not everyone uses it on labels. This industry-led initiative aims to implement traceability across the entire produce supply chain by using common industry standards such as the GS1 US barcode and electronic storage and retrieval of that data. The GS1 US barcode includes the brand owner, lot number, and processing date for the produce. “One of the long-standing challenges is getting owners in the supply chain to capture that information, which remains on the box—but the box gets thrown away,” she says.
Yiannas, who formerly was vice president of food safety at Walmart, outlined some of the challenges of traceback in a statement last December about the various romaine lettuce recalls in 2018 and 2019. Calling traceback investigations “resource and time-intensive,” he said they cannot begin until someone reports being ill. “Once the initial evidence is laid out, a traceback investigation includes investigating retail establishments, suppliers and distributors and working our way back to the farm or farms that may have grown the lettuce that ended up in consumers’ meals and homes,” he wrote. “It’s a labor-intensive task requiring collecting and evaluating thousands of records while also trying to accurately document how the contaminated lettuce moved through the food supply chain to grocery stores, restaurants, and other locations where it was sold or served.” But because of the expansive nature of the romaine lettuce E. coli outbreaks, “our investigation remains a complicated work in progress, and it is too soon to draw definitive conclusions,” he added.
What has helped FDA make progress in its investigations to detect and even link cases of foodborne illness are whole genome sequencing DNA-fingerprinting technology, coordination among federal and state agencies, and the voluntary adoption by many companies of best-practice labels.
The labeling is one change that was made in the past few months, spearheaded by a group of major grocery companies, Dr. McEntire says. The Leafy Greens Safety Group comprises Walmart, Kroger, Costco, Wegmans, and Yum! Brands.
Last October the group endorsed the recommendations of the Romaine Task Force, which itself was formed by United Fresh and the Produce Marketing Association at FDA’s request following the November 2018 E. coli outbreak in romaine lettuce that sickened 62 people and sent 25 to the hospital. That outbreak followed one of the largest and most deadly romaine E. coli outbreaks in the spring of 2018 that resulted in 210 cases of sickness across 36 states, five deaths, and 96 hospitalizations, according to CDC. There also was an outbreak around Thanksgiving of 2019.
This group of five companies came together to support the Romaine Task Force recommendations on traceability, boost their own company’s traceability, and work with the supply chain to improve the capture of data for traceback, Dr. McEntire says. One result from the task force is that the group initiated labels that carry the origin location of romaine lettuce—for example, Yuma or Salinas, two areas of California that produce romaine. And while Dr. McEntire says more granular information such as the barcode that can track products to the individual grower and field is needed for traceability, the regions on labels can help consumers, including herself. “During the Thanksgiving 2018 E. coli outbreak in romaine lettuce, FDA said don’t eat any romaine lettuce. But [in the 2019 outbreak, FDA] knew it was OK to eat romaine from Yuma, but not from Salinas,” she says. “I had romaine hearts in my refrigerator that had a sticker saying they were from Salinas and thus were subject to the alert.”
Dr. McEntire says a lot of data is available that companies don’t use, but the collaboration of the five major produce retailers could change that. “The five companies are influential and have peer pressure. And FDA is increasingly vocal about the challenges they face when investigating outbreaks,” she adds.
Yiannas wrote that the labeling practices and technology-enabled traceability now in use by some companies “help to target consumer advice to a defined growing region, compared to [2018’s] advisory, which was to avoid romaine lettuce nationwide regardless of where it was grown.”
Even if there is an advisory and not a recall, the product can’t be sold and needs to be discarded. “There are economic consequences for everyone in the supply chain,” says Dr. McEntire.
New Technologies
Bhatt of Walmart is eager to push ahead with new technologies that improve transparency and traceability throughout the retailer’s extensive supply chain. “I refuse to accept these continuous outbreaks with romaine lettuce in the last few years as the new norm,” he says. “The industry and agencies don’t want that to become the new normal. So, what can we do to push industry to do better to protect customers? I believe they’re going to embrace technology.”
He said Walmart wants to protect customers from outbreaks and retain their trust by being more proactive and less reactive. One of its strategies is using blockchain technology, which uses blocks of information stored in a shared database. Blockchain technology for traceability is available from companies including IBM, Hyperledger Fabric, and FoodLogiQ Connect. “We looked at several technologies, including traditional traceback,” Bhatt says. “Blockchain was relatively new and we weren’t sure there was something behind the hype. That’s why we decided to do two pilot studies, one in mango in North America and one in pork in China.”
The two proof-of-concept pilots convinced him that there is value to blockchain technology that goes beyond the traditional approach to traceability. Among other things, Walmart discovered it could trace the origin of the mangoes it was selling within 2.2 seconds, much faster than the prior timeline of seven days.
Walmart subsequently launched a one-year pilot and invited its large buyers and some competitors to participate. It spent a full year testing, learning, and scaling blockchain technology with the partners across two dozen SKUs before it officially launched a Walmart initiative with leafy green suppliers in September 2018 using blockchain technology. “The Yuma romaine lettuce outbreak from March 2018 was fresh in our minds,” Bhatt says. “That was before we knew there would be another large advisory in November 2018 as well as November 2019.”
Walmart gave its three dozen leafy green suppliers one year to onboard to the blockchain platform. “What that means is that before they ship leafy green products from their facilities to our distribution centers, we need to know which farms they came from and when they were harvested,” Bhatt says. “With the success of that launch, we expanded the initiative to our green bell pepper suppliers in July 2019.” There are approximately 40 suppliers of bell peppers that have until July 2020 to adopt blockchain technology from the farms to the retail store.
Hitchcock of IFT said big retailers have a major voice in the requirements for traceability in the supply chain. Some of the advantages of blockchain technology are its speed and the fact that the documentation of transactions can’t be changed after they are posted.
“One of the key strengths is the fact that blockchain is an immutable ledger where the data can’t be changed. That improves the quality of the data,” says Bhatt. “And blockchain is a consensus mechanism. If there’s a shipment event there needs to be a receiving event. The quantity must be aligned. Reducing disputes creates efficiencies in the supply chain. You don’t want to be identifying inconsistencies during a crisis.”
He adds that he considers blockchain to be “democratic” in that it is not controlled by one company, so it’s faster to get to the root cause of a problem. “There are efficiency gains that reduce the overall cost of technology and traceability,” he says.
This is important because the number of recalls is increasing, according to Hitchcock. “That’s less tied to the ability to track them and more to the increased ability to detect issues,” he says. “We’re getting more data in sharable form with new handheld data collection devices and blockchain or cloud software.”
There has been an uptick in the use of blockchain technology, says Kevin Otto, MBA, senior director of community engagement GS1 US, a nonprofit offering voluntary standards for barcodes based in Ewing, N.J. “We’re seeing more blockchain software players,” he says. “IPC-Subway uses our standard so it can send push notifications to only the impacted restaurants.” That allows food service companies to track batch lots and throw away only the affected food rather than all food. “It’s faster and safer,” he adds. “Blockchain also can enhance other business practices.”
Coming Regulations
Dr. McEntire of United Fresh says industry participants are eagerly awaiting FDA’s announcement of the high-risk foods and what additional recordkeeping for traceability will be needed. “I expect they will be aligned with the Produce Traceability Initiative,” she says.
Hitchcock says that, while it still isn’t clear which foods will be included, any food without a final microbial kill step could be considered high risk. That includes raw foods such as fish, vegetables, fresh foods, and items in quick restaurant buffets.
Some are concerned FDA’s smarter food safety initiative may become a de facto requirement, says Dr. McEntire. “But, from my perspective, many companies are already adopting technology,” she adds. “For blockchain, you need good quality data and data that are relatable to each other between supply chain partners.”
Bhatt says that with its blueprint, FDA is intent on elevating the baseline for food safety across the industry. “There will always be leaders like Walmart, but FDA will send a strong message to the rest of the industry that they need to do better,” he says.
One of the key questions is what to do with all of the data that will be collected. “The industry needs education and training as it brings new digital technologies to the workforce,” Hitchcock says. “We need knowledge to handle large data sets and make business decisions based on the information.”
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