Earlier this month, FDA announced finalization of its food traceability rule, which the agency says is designed to more effectively trace contaminated food through the food supply, whether sourced in the U.S. or abroad.

The final rule establishes additional food traceability recordkeeping requirements for those that manufacture, process, pack, or hold certain foods, including fresh leafy greens, nut butters, fresh-cut fruits and vegetables, and ready-to-eat deli salads. In collaboration with industry, FDA says it will be able to more rapidly and effectively identify the origin and route of travel of certain contaminated foods to prevent or mitigate foodborne illness outbreaks, address credible threats of serious adverse health consequences or death, and minimize overly broad advisories or recalls that implicate unaffected food products.

“This rule lays the foundation for even greater end-to-end food traceability across the food system that we’re working on as part of the New Era of Smarter Food Safety initiative,” said Frank Yiannas, FDA’s deputy commissioner for food policy and response, in a November 15 statement. “This standardized, data-driven approach to traceability recordkeeping helps create a harmonized, universal language of food traceability that will help pave the way for industry to adopt and leverage more digital, interoperable and tech-enabled traceability systems both in the near term and the future.”

Foods subject to the final rule requirements appear on the Food Traceability List (FTL). To determine which foods should be included on the FTL, FDA developed a risk-ranking model for food tracing based on the factors that Congress identified in Section 204 of the FDA Food Safety Modernization Act (FSMA). These foods include fresh leafy greens, melons, peppers, sprouts, herbs, tomatoes, cucumbers, and tropical tree fruits, as well as shell eggs, nut butters, fresh-cut fruits and vegetables, ready-to-eat deli salads, cheeses (other than hard cheese), finfish, and crustaceans.

Key features of the final rule include:

• Critical tracking events: At specific points in the supply chain—such as at harvesting, cooling, initial packing, receiving, transforming, and shipping FTL foods—records containing key data elements are required.
• Traceability plan: This information is essential to help regulators understand an entity’s traceability program and includes a description of the procedures used to maintain required records, descriptions of procedures used to identify foods on the FTL, descriptions of how traceability lot codes are assigned, a point of contact for questions regarding the traceability plan, and a farm map for those that grow or raise a food on the FTL.
• Additional requirements: Maintaining records as original paper or electronic records, or true copies; providing requested records to FDA within 24 hours of a request (or within a reasonable time to which the agency has agreed); and providing records in an electronic sortable spreadsheet when necessary to assist FDA during an outbreak, recall, or other threat to public health.

FDA says that these enhanced recordkeeping requirements for FTL foods outlined in the final food traceability rule will allow for faster identification and rapid removal of potentially contaminated food from the market, ultimately resulting in fewer foodborne illnesses and deaths.

The compliance date for the recordkeeping requirements is January 20, 2026.

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Each year, foodborne illnesses sicken 48 million Americans (approximately 17% of people in the United States) and lead to 128,000 hospitalizations and 3,000 deaths, according to the CDC. “Although there have been great improvements in technologies to track and trace foods from farm to table, and remove recalled foods from the market, many are expensive to deploy and maintain,” says Emily R. Lyons, JD, senior associate attorney working in the food and agribusiness industry group at Husch Blackwell LLP, in Washington, DC. “This makes them cost prohibitive for smaller and medium-sized businesses.”

In light of this problem, FDA issued a New Era of Smarter Food Safety initiative in July 2020, to leverage technology and other tools to create a safer and more digital, traceable food system. Then, in June 2021, FDA asked stakeholders to recommend low-cost or no-cost options in its No-Cost Tech-Enabled Traceability Challenge so that approaches are inclusive of and viable for human and animal food operations of all sizes. “Democratizing the benefits of digitizing data will allow the entire food system to move more rapidly toward digital traceability systems,” says Frank Yiannas, FDA’s deputy commissioner of Food Policy and Response.

FDA’s challenge called on technology providers, public health advocates, entrepreneurs, and innovators from all disciplines worldwide to develop traceability hardware, software, or data analytics platforms that are low cost or no cost to end users.

Developing and deploying low-cost and no-cost traceability tools will benefit everyone by increasing organization participation, improving data capture and sharing, and accelerating foodborne illness outbreak response.—Bryan Hitchcock

The deadline for submissions is July 30. The tech-enabled solutions could be new or based on existing systems or datasets. Of those who scored the highest based on the evaluation criteria, up to 12 winners will be announced at a future date.

Yiannas believes that a number of technologies can be employed to track and trace foods. But because the food system is large, distributed, and decentralized, traceability solutions that are simple to use, cost-effective, and interoperable are more likely to be rapidly adopted. “By having an open challenge, FDA may become aware of new technologies and business models that they didn’t previously consider,” he says. “If FDA limited participants to a specific type of technology or problem to solve, it would most likely restrict the range of ideas brought forth.”

Possible Solutions

Tejas Bhatt, MS, CFS, senior director of U.S. and Global Food Safety Innovation at Walmart Inc., in Bentonville, Ark., supports FDA’s choice not to be too prescriptive when it comes to the types of technologies that might be suitable, because, he says, the solution won’t be one-size-fits-all. “We need the industry to innovate and solve this problem collectively, instead of having data sit in silos using proprietary standards and be closed off to commercial solutions,” he says. “Data should flow from one technology solution that might work for a farmer to another technology solution that might work for a larger company like Walmart.”

Lyons says current options could be expanded for use in the food system. The key elements of a good solution are automation of data collection and the ability to collect consistent information (known as key data elements) at many different points in the supply chain (known as critical tracking events).

The types of innovations that are necessary will largely depend upon an entity’s specific role in a supply chain. Food producers may be more interested in how to generate real-time data regarding their crops and the inputs used to produce them and how to generate that information in a way that can be easily communicated up the supply chain, Lyons says. Manufacturers may desire additional innovations in blockchain, robotics, the Internet of Things, and in-line sensor technology. Meanwhile, retailers may want tools that help meet brand or consumer expectations for products and ways to communicate that to consumers at the point of purchase.

Consumers are looking for information, such as the raising conditions of, labor conditions for farmworkers, information about the farmer who produced the product, or details about an ingredient and its purpose in a product, to be presented and shared in a single application, Lyons adds.

Synchronizing Platforms

In addition to addressing the specific needs of primary producers, importers, manufacturers, processors, distributors, retailers, and foodservice establishments, solutions will have to allow for data sharing across platforms used by various segments of the food supply chain, which could be challenging, Yiannas says.

Although synchronizing platforms is not an entirely new concept, it is new in the food sector, Bhatt says. For example, financial institutions synchronize across platforms, allowing consumers to use ATM cards in any ATM worldwide. Telecommunication organizations synchronize the transfer of voice, text, and data across platforms, enabling people to communicate with family, friends, and colleagues around the globe. For the food sector, there will need to be a similar process to develop global open standards.

Benefits Abound

Digitizing the supply chain will enable small- and medium-sized organizations to participate in the food ecosystem. After data is digitized, the next step will be to create transparency. “Retailers such as Walmart and its customers want to know where the food we sell comes from,” Bhatt says. “Simultaneously, growers can benefit from knowing where their food ends up in the supply chain, which will give them better market access.”

Finally, supply chain optimization will occur, through increased shelf life, reduced waste, improved quality, and ultimately, better customer satisfaction. “The important paradigm shift here is that instead of one type of stakeholder gaining all the benefits, the benefits can be shared across the supply chain or ecosystem,” Bhatt says.

Bryan Hitchcock, senior director of food chain and executive director of the Global Food Traceability Center at the Institute of Food Technologists in Chicago, Ill., says the ability to improve public health by reducing foodborne illnesses will be one of traceability’s greatest benefits. “Developing and deploying low-cost and no-cost traceability tools will benefit everyone by increasing organization participation, improving data capture and sharing, and accelerating foodborne illness outbreak response,” he says.

Lyons says that the availability of more tools for traceability will assist food manufacturers of all sizes to track and trace foods in instances where a recall is necessary. These tools can also help pinpoint exactly what products should be recalled depending upon the depth of the traceability tools (i.e., specific ingredient tracing as well as finished product tracing). These traceability tools will also have the ancillary benefit of increasing transparency within the food system to benefit consumers.

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<h3>Examining the Blueprint for Smarter Food Safety</h3>

FDA’s New Era of Smarter Food Safety created a blueprint for the application of technology and smarter tools, while harnessing the collective power of people. “Our food system is evolving rapidly, challenging all stakeholders to adapt,” says Bryan Hitchcock, senior director of food chain and executive director of the Global Food Traceability Center at the Institute of Food Technologists in Chicago, Ill. “Creating an enduring regulatory framework which leverages and embraces the latest technology, while also addressing the human aspect of food safety, are critical to ensuring a safe and abundant future food supply.”

Here’s a closer look at the blueprint’s four pillars.

1. Tech-enabled traceability eventually will be a “system of systems” where each stakeholder in the food system will be free to choose whatever traceability solution works for them. However, Tejas Bhatt, MS, CFS, senior director of U.S. and Global Food Safety Innovation at Walmart Inc., in Bentonville, Ark., says that all solutions will need to speak the same language, allowing the data to flow from one system to another (with adequate protections) as food moves through the supply chain.
2. Smarter tools for prevention will use the data from tech-enabled traceability and other sources to better predict failure before it happens. “The aerospace and automotive industries already do this; there is no reason to believe that it can’t also be done in the food industry,” Bhatt says.
3. Retail modernization is happening now and was accelerated by the pandemic. “More of Walmart’s customers are shopping online and having their groceries picked up or delivered via the Walmart and Sam’s club app,” Bhatt says. “We’re better able to connect customers with the supply chain that served them their food, making epidemiological interviews and outbreak investigations easier and more accurate.”
4. A tech-enabled food safety culture can deliver the promise of creating awareness for, educating, and modifying the behaviors of all stakeholders of the food system, including customers, to ensure food safety. “Whether it’s through social media platforms or home automation, the ability to reach the population in a manner they want to be reached has never been easier,” Bhatt says.

Emily R. Lyons, JD, senior associate attorney working in the food and agribusiness industry group at Husch Blackwell LLP, in Washington, DC, sees the blueprint as two-fold. First, it’s a call for FDA and industry to implement existing technology and develop new technology to enhance food safety and communicate the safety of the U.S. food system. Second, it’s a chance for FDA to learn how to adapt its regulatory schemes and innovative business models such as the proliferation of food meal delivery companies.

“We’re at a point where there is still a lot to learn about how FDA plans to use this blueprint to influence policy, but we’re already seeing that FDA is encouraging technology adoption, even without explicitly requiring it, through the FSMA Proposed Rule for Food Traceability,” Lyons says.

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A group of food industry organizations has released a report that outlines four months of leafy green traceability pilot programs with supply chain partners, including growers, distributors, and independent and chain retailers. The researchers found that investigations into foodborne illness outbreaks could be streamlined and conducted more effectively when supply chain members provide extended product information during tracebacks.

Additionally, the investigators found that use of a standard template to exchange pertinent product information enhanced the speed of tracing procedures. All of the pilots were successful in tracing the source of the affected product.

The pilots tracked romaine lettuce through three separate supply chains, starting with actual consumer purchases made with loyalty cards or credit cards. Small teams of industry experts mimicked FDA’s role in conducting the traceback, including determining which data was to be requested and how to format the requests for such data. Supply chain members used the template to provide key data elements that allowed an item to be traced back to its source.

Notably, the data that enabled each of the teams to independently and successfully identify the finished product lot purchased by the consumer is not currently captured by the template, according to a statement released by the organizations. “These data included business intelligence such as sales data, stock rotation, inventory controls, and delivery schedules. These were critical in bracketing the scope of the traceback.”

“The pilots provided valuable insights that will inform future outbreak response and recall protocols, helping industry to work together to support the FDA’s focus on tech-enabled traceability,” said Bryan Hitchcock, executive director of the Institute of Food Technologists Global Food Traceability Center, in the statement.

The organizations that led this activity included FMI-The Food Industry Association, GS1 US, the International Foodservice Distributors Association, the Institute of Food Technologists, the Produce Marketing Association, and the United Fresh Produce Association.

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Frank Yiannas, FDA’s deputy commissioner for food policy and response, says that the first 100 days since the FDA released its blueprint for the “New Era of Smarter Food Safety” has been a success.

In a webinar that took place on Oct. 26, Yiannas joined with other FDA leaders to discuss the highlights of the program so far, including advancements and achievements made in food safety and leveraging technology and other tools to create a safer and more digital, traceable food system. “Smarter food safety is people led. It requires smart, innovative people and increasingly technology enabled,” Yiannas said. “This has proven to be a collaborative, action-oriented blueprint.”

Speakers discussed the work done by FDA team members on the four core elements of the New Era of Smarter Food Safety blueprint—tech-enabled traceability, smarter approaches to prevention and outbreak response, new business model and retail modernization, and food safety culture.

“The lessons we learned in the months following the pandemic accelerated the needs for many of these goals,” Yiannas said. “For example, we learned enhanced real-time traceability could provide greater supply chain traceability that could help FDA and the industry to anticipate the types of market checks and balances that we saw during the pandemic.”

Another example is that, during the pandemic, FDA started remote inspections. The pandemic also shined a light on other aspects of the food safety culture, and this helped FDA make its blueprint a reality. “There won’t be a New Era without the commitment and involvement of invaluable partnership of government agencies, industry associations, academic institutions, and consumer advocates,” Yiannas said.

Kari Irvin, deputy director of the Office of Coordinated Outbreak Response and Evaluation in the Center for Food Safety and Applied Nutrition (CFSAN), spoke about establishing a tech-enabled traceability system that would create a harmonized system of traceability from farm to fork. She talked about how this new data will help shape the current investigational tools, especially when applied to food outbreaks and identifying causes.

“The first 100 days has been really eventful for us; we were pleased to launch the Leafy Greens Tracing pilot, where we were able to partner with the leafy green industry to create scenarios for testing methods to collect and report traceability data,” Irvin said.

Additionally, in August, an independent response outbreak process review was initiated to seek input from consumer groups, academia, government agencies and industry to open a dialogue on FDA’s current outbreak response process, with a particular focus on traceability.

Next up was Mark Moorman, director of the office of food safety, who spoke about the Core 2 segment of smarter tools and approaches, and emphasized the importance of information sharing, both within industry and government, to learn from adverse effects. He also noted how data analysis will help predict future outbreaks.

Andreas Keller, FDA’s director of multi-commodity foods in the office of food safety, examined the new business models and retail modernization, and spoke on FDA’s recent efforts to evaluate the effectiveness of retail food regulatory programs. Conrad Choiniere, director of the office of analytics and outreach, addressed food safety culture, noteing that FDA’s role is to study the issues and provide advice so that those in the industry can develop their own food safety cultures tailored to their specific needs.

Looking at the road ahead for 2021 and 2022, Irvin said that a key FDA goal is to finalize the food traceability rule.

Additionally, FDA looks to implement the following:

• Build a platform to rapidly receive electronic tractability data;
• Initiate discussions with domestic and internationals stakeholders related to integrating traceability efforts;
• Expand traceability pilot activities beyond leafy greens;
• Make changes to digital trace back requests; and
• Encourage the development of simple, low-cost solutions to promote tech-enabled traceability and to meet the requirements of the FSMA Food Traceability Rule when finalized.

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FDA has proposed a new rule that lays the foundation for end-to-end food traceability across the food industry as part of the New Era of Smarter Food Safety initiative.

While limited to certain foods, the proposed rule is designed to create a first-of-its-kind standardized approach to traceability record keeping, paving the way for the food industry to adopt and leverage more digital, tech-enabled traceability systems in the future.

“At a high level, what this is really trying to achieve is to lay the foundation for a more standardized approach to food traceability by harmonizing and identifying what are the records that need to be care, and in turn, serving as a catalyst for greater end-to-end digital food transparency,” Frank Yiannas, FDA deputy commissioner, tells Food Quality & Safety.

The proposed rule is looking to correct what he notes is often “one step up and one step back” with regard to other countries’ proposals for food traceability, where people are keeping records in different ways with no standardized data.

“What the FDA has done here is require people to ‘speak in the same or similar language,’ which will allow us to make those connections and show how food travels from farm to table,” he says. “This is a game changer in food traceability in that it identifies very appropriately and astutely in a 21st century fashion the key data elements and the critical tracking events that are needed.”

Yiannas notes that the proposal is aimed at all food manufacturers, processors, packers, and those who hold foods on the Food Traceability List (FTL).

“Working together, we will advance food traceability and usher in a new era of smarter food safety that benefits producers and consumers,” he said. “Over the course of the next 100 days, you should expect significant announcements about our plan.”

There will be a series of public meetings about the proposal before a final rule is approved.

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The two-year grace period allowing automatic on-board recording devices (AOBRDs) in place of electronic logging device (ELD)-compliant devices for electronically tracking hours of service in commercial trucking fleets expired in December 2019. This means that food manufacturers with distribution fleets that did not upgrade to ELD-compliant devices but were operating under the AOBRD extension should have already made a commitment to an ELD provider and service.

Additionally, food manufacturers and distributors operating under the AOBRD extension for the last two years are now faced with the same decisions that fleets had to make when the ELD mandate was initially put into place: Who do I select as my provider? It is now even more important that companies not make hasty decisions that can set them back with regard to data and technology.

The ELD conversation for food manufacturers and their distributors is larger than just an hours-of-service (HOS) determination, especially for time-sensitive and temperature-sensitive operations, due to the passing of the Food Safety Modernization Act (FSMA). ELDs are also part of a broader discussion about telematics and on-board computers and the use of telematics to optimize data that comes from the truck, as well as the use of that data for overall fleet compliance, analytics, and operations.

ELDs can be a different technology than an AOBRD. ELDs are not required to capture all the operating data that your AOBRD may have been capturing. ELD data requirements are focused and governed based on the HOS rules; what this means is that food manufacturers and their distributors need to be careful in their selection to ensure they do not focus only on ELD compliance. Food manufacturing and fleet executives need to also determine what data they need in order to continue to manage their food distribution fleet efficiently and in compliance with FSMA. For example, they may select a compliant ELD but may lose important operational data, including load data, maintenance data, and fuel data, used to monitor total cost of ownership.

Data Rich

AOBRDs have been around for several years and can capture an extensive amount of data. Many telematics providers have upgraded their technology to maintain their data collection and monitoring capacities and enhance them with the ELD mandate compliant functionality. These devices will continue to record the same data as the AOBRD; however, newer ELD devices and services may not be collecting the same rich data set.

The ELD mandate opened a vast market of opportunity that attracted several new providers claiming to be ELD-compliant. Many of these providers are focused on ELD compliancy and not the valuable fuel, diagnostic and fault code data, or load-specific data that might be needed for food distributors under FSMA.

When switching to ELDs, food manufacturers and their distribution fleets need a few key questions answered: Are they giving up or did they give up access to critical data they have been historically using, and are they giving up access to data that would help with FSMA compliance in the future? This depends on the viability of the technology platform offered by the provider. If fleet managers are not careful, they may lose out on critical truck data they can use, or have been using, for performance optimization via data analytics.

This additional data could be of further use to food distributors with time- and temperature-sensitive loads. These organizations rely on identifying longer idling times and, when combined with temp-sensitive orders, can greatly impact fuel expenditure and critical routing data that can also impact perishable deliveries. What’s more, FSMA mandates that sanitary transportation of food requires temperature monitoring and control to prevent refrigerated/frozen food from becoming unsafe during transportation. This information can be monitored with the right ELD telematics solution.

Food distributors need to have more stringent routing plans in place for deliveries, as data extracted from the ELD might make it more difficult for time- and temperature-sensitive operations to remain compliant. A real scenario is a load time- and temperature-sensitive load being stranded because the driver is out of hours, not only delaying it but also potentially putting the whole load at risk.

Choosing a Vendor

Do food distributors view the telematics mandate as a “necessary evil” and spend the least amount to meet compliance, or do they go “all-in” and realize the value of the data that the entire ecosystem provides to the operational bottom line?

Amid the overload of applications, hardware, and services available in the ever-changing telematics world, deciding on the range of system functionality and associated costs can be overwhelming. Pricing for hardware can range from free to several thousand dollars per truck, while functionality can range from basic GPS tracking to a fully integrated mobile asset management system. With options that include vendors, applications, features, and costs, where do fleets begin?

Fleet managers must look beyond ELD compliance and think strategically about the data they need to manage their food distributor’s compliance and performance, their drivers’ behaviors, and their vehicle lifecycles that will ultimately pay off in improved fuel economy, enhanced preventative maintenance, lower operating costs, and improved driver retention.

The hardware is just the first decision. Fleets must also choose a provider/partner that is there for the long haul, that can support the organization and fleet well into the future. A short-sighted decision to simply meet the ELD mandate without understanding the “actionable data potential” for greatly reducing operating costs is still ill advised. The incremental costs to acquire systems and services that provide additional data and applications to modernize the fleet are minimal, and the return on investment is substantial.

By attempting to minimize this step and focusing strictly on ELD compliance, fleets will find they have lost substantial operational savings and competitive advantage and will experience increased costs that could have been avoided with access to actionable decision-making data that can assist in optimizing the food distributor’s fleet performance.

What does a good partner/vendor look like?

1. 1. How long has the organization been providing fleet telematics? Fleets need a provider with a legacy of providing solid telematic technology and services. Telematics and transportation technology encompass a lifetime of lessons learned. These go beyond the technology and involve understanding how the technology impacts the operation of the fleet. No two fleets are the same.
   2. What does the organization’s technology roadmap look like? What is its strategy for the advancement of technology in the future, and how will that strategy impact the collection and interpretation of data? Remember, this is a long-term investment, and it is unwise for fleets to jump between providers frequently. The operational disruptions/costs alone will deplete any realized savings. Fleets also don’t want to lose any competitive edge due to their competitors’ actionable data strategies.
   3. How good is the organization at deployment and support services? It is important to find a partner that understands all complexities involved, from planning to execution, and is there to work with fleet management teams to overcome any unforeseen challenges.

Choosing the right business intelligence partner can help fleets interpret the abundance of data that’s collected by the AOBRD and ELD. Beyond this critical interpretation, the right partner offers its own technology resources that can help fleets make sense of data from many different platforms and sources—a difficult action when fleets try to make sense of data on their own. With the right partner selection, fleets can be compliant and obtain business intelligence and analytics, allowing them to maximize the value of the data they extract from each truck to create both operational and bottom-line financial efficiencies that provide significant return on the investment into the technology itself, as well as their partnership with the data purveyor.

Griffin is chief operations officer and chief technology officer for Fleet Advantage. Reach him at info@fleetadvantage.

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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.”

The post A Look At the New Technologies in Traceability appeared first on Food Quality & Safety.

According to a report by the U.S. Public Interest Research Group, the total number of food recalls in the U.S. increased by 10 percent between 2013 and 2018. In the last year alone, the USDA Food Safety and Inspection Service recalled over 10,000 tons of food. Food quality issues have contributed to the roughly 48 million who people get sick, 128,000 who are hospitalized, and 3,000 who die from foodborne diseases each year in the U.S., based on estimates by the U.S. Centers for Disease Control and Prevention.

One of the key challenges that food manufacturers face in preventing recalls is how to ensure their suppliers maintain effective quality management procedures. This includes monitoring food supplies that come from foreign countries; there are more than 200 countries or territories (and roughly 125,000 food facilities and farms) that supply 32 percent of the fresh vegetables, 55 percent of the fresh fruit, and 94 percent of the seafood that Americans consume annually.

Unfortunately, many importers still rely on manual processes that are limiting their ability to keep track of supplier data and quality processes. This not only puts consumer safety at risk but can also inhibit a company’s ability to comply with FDA regulations. Organizations that struggle to locate data because they’re forced to sift through paper records are likely to be flagged during an inspection. Instead of relying on manual methods, importers should look for a software solution that can house all their critical quality data in one central, easy-to-access location. Not only does centralizing data make it easier for importers to address the FDA’s questions, but it also enables them to more efficiently and effectively manage suppliers.

Finding a Solution for Food Suppliers

By investing in a supplier quality management tool, importers will have direct access to critical compliance and quality data, such as materials, testing and sampling records, audit findings, and corrective actions. Additionally, with the right tool, importers will be able to update data in real-time and require their suppliers to do the same. As an added bonus, this level of automation will significantly streamline previously manual processes, giving both importers and suppliers the resources they need to focus on what matters most: the safety and quality of the product.

The most effective supplier quality management tools can ensure finished product quality with automated control and visibility over all elements in an organization’s supply chain—from local manufacturers to global suppliers. Importers should look for solutions that can track suppliers and materials, build qualitative and quantitative supplier ratings, and trigger actions to improve supplier quality, all from one, easy-to-use interface. Ideally, the solution will be able to automatically:

• Track and evaluate the quality of supplier goods in real-time.
• Identify scenarios that may warrant supplier corrective action, such as nonconforming material, missed or delayed delivery, and investigation of a customer complaint.
• Manage the approval process for changes to products and processes made by suppliers.
• Generate reports for suppliers categorized by commodity and date.

For one global provider, leveraging a sophisticated quality management solution that incorporated the above features was critical to its success. With the right software in place to automate contract management processes, the organization was able to achieve a 5,000 percent return on investment and significant productivity gains. Another national fast-food chain centralized and automated its vendor approval system, which allowed it to shave weeks off its vendor approval process and get new products to market faster without sacrificing food safety.

This type of solution is especially helpful when navigating the complexities of the FDA’s recently enforced Foreign Supplier Verification Program (FSVP), a key compliance and safety rule under its Food Safety Modernization Act (FSMA). With the number of food recalls increasing and the threat they represent to U.S. consumers, manufacturers, and the economy, it’s no surprise that the FDA is cracking down by enforcing one of its key regulations around imported goods. Foreign food suppliers and U.S. importers that are uncertain about whether they’re ready for the inspections should first take a step back and review their quality processes to ensure they—and the other companies operating in their supply chain—are meeting every one of the FDA’s compliance and safety rules.

Getting to Know the FSVP

The FSMA has been referred to as the most sweeping reform of U.S. food safety laws in more than 70 years. The focus of the act is to ensure more effective prevention of safety issues in the U.S. food supply by taking a comprehensive overhaul of every segment of the supply chain, from farm to fork. It was signed into law by then-President Obama on Jan. 4, 2011, and in the years since the FDA has been working to develop the final rules.

One of those rules is the FSVP, which at its most basic level requires that the same food safety standards are applied to all foods sold in the U.S., whether they’re produced in Minnesota, Mexico, Morocco, or Montenegro. The program puts the onus on U.S. importers to verify that their foreign suppliers are producing food in a manner that provides public health protection and to ensure that the supplier’s food isn’t adulterated or misbranded with respect to allergen labeling.

The rule was formally finalized in 2015 and the first compliance date was set in May 2017, with compliance dates extending throughout 2020. According to the FDA, compliance dates for FSVP are based on:

• The foreign supplier’s size: Companies will have a longer amount of time to comply with FSVP rules when suppliers qualify as small or very small businesses. The FDA has helpfully provided a Small Entity Compliance Guide
• The company’s role in the food supply chain: Importers that are also manufacturers and subject to supply-chain provisions of preventive control rules should refer to compliance dates in those established rules. If this is applicable, then those rules may provide more time for compliance than the FSVP dates outlined on the FDA website.
• Whether suppliers are subject to other rules: Importers whose suppliers are already subject to preventive control or produce safety rules may also have more time to demonstrate compliance.

Evaluating Foreign Food Suppliers

Under the FSVP, importers are responsible for leading the evaluation of their foreign suppliers, which includes taking actions such as:

• Determining known or reasonably foreseeable hazards with each food.
• Evaluating the risk posed by a food, based on the hazard analysis and the foreign supplier’s performance.
• Using that evaluation of the risk posed by an imported food and the supplier’s performance to approve suppliers and determine appropriate supplier verification activities.
• Conducting supplier verification activities.
• Conducting corrective actions.

“Hazards” are anything defined as being reasonably likely to cause illness or injury that occur naturally, are unintentionally introduced, or are intentionally introduced for the purposes of economic gain, such as substituting a less-costly ingredient. This could include:

• Biological hazards, such as parasites and disease-causing bacteria.
• Chemical hazards, including radiological hazards, pesticide and drug residues, natural toxins, food decomposition, unapproved food or color additives, and food allergens.
• Physical hazards, such as glass or metal.

If an importer finds that one of their foreign suppliers is at risk for nonconformity or is using processes and procedures that might put public health at risk, the importer must promptly take corrective actions. These actions could include discontinuing the use of that supplier until the cause of noncompliance has been addressed. Importers are also subject to their own set of conformities that ensure their quality and safety standards adhere to the FDA’s regulations.

Beyond investing in software, importers should also identify ways to prepare their suppliers for FSVP inspections, such as performing a mock inspection. By taking the time to walk through all the FSVP criteria ahead of time, importers will be able to pinpoint any challenges or quality concerns that need to be addressed before the FDA inspectors arrive.

While FSVP preparedness is undoubtedly time-consuming for suppliers and importers alike, it’s also critical to ensuring the safety of our products and, ultimately, our consumers. And although it’s essential that importers get themselves and their foreign suppliers ready for inspection as soon as possible, it’s even more important that they establish quality management best practices to consistently ensure the quality of the products they deliver to the public, support more efficient supply chain management, and instill consumer trust. Thankfully, with the right tools and processes in place, every company will be able to easily maintain compliance and product quality year-round.

Isaacson is senior director of product marketing at ETQ. Reach him at disaacson@etq.com.

The post Using Software to Make Sure Food Suppliers Are FDA Compliant appeared first on Food Quality & Safety.

Traceability requirements are costly. The financial risks and costs associated with food safety are increasing due to trade wars and retaliatory uncertainty. The stakes are rising for food suppliers in a landscape of continuously evolving food safety challenges, technologies, and regulations. An increasingly complex food chain with many touch points and value-added products has increased the potential points of contact and opportunities for contamination. It has also increased the complexity of traceability.

Often, the requirement for lot traceability drives manufacturers to incur a higher cost than anticipated. By avoiding additional labeling during receiving and finished goods creation, effective, lean processes are implemented; on the receiving side, food manufacturers leverage barcodes coming in the door. If that is not possible, license plate (LP) barcodes can be used to meet the traceability requirement without labeling each case or component. Advanced technology allows for reliable traceability throughout the food supply chain and enables faster identification of food safety issues.

License Plates and Food Production

WithoutWire Inventory Sciences defines a license plate number as any object that holds items. Although LPs are associated with containers, they do not need to represent a physical entity, such as a box. Food safety and operations managers define an LP as a collection of items enabled for tracking, transacting, and nesting.

LPs have specific functionality to support detailed chain-of-custody requirements; they identify how to receive, store, and pick material by LP as well as viewing on-hand balances. Traceability challenges vary from basic queries of accurate inventory on hand, location of inventory, where it was sourced (including country of origin labeling). Additional information must include where inventory was moved throughout the day. Automating this data ensures the right mix of SKUs based on history and compliance issues.

Single-scan functionality results in 99 percent-plus accurate data and adds value throughout the supply chain as well as downstream for the customer. Organizations must be able to track inventory expiration dates and eliminate physical errors to improve accuracy and order fulfillment. As more retailers enforce compliance, distributors will now be equipped with the tools needed to reduce the risk of rejected shipments. Standardized electronic traceability across the supply chain will allow each handler to support internal traceability solutions.

The Industrial Internet of Things (IIoT) supports traceability to course-correct business performance. Access to these advanced analytics allows food scientists to identify and remove suspect product from the marketplace as soon as possible to safeguard public health. Simultaneously, product not implicated in an outbreak can stay on the market, and business can return to “normal” as soon as possible.

The Case for License Plate Traceability

When it comes to finished goods, license plates and item and IIoT barcodes are both options that reduce the total number of scans. When creating goods with an expiration date, it is best to automatically set the expiration date with an item-level, shelf-life setting. Proper planning, along with smart item tracking, drives the difference between making or losing money.

Because QC/QA professionals can view LP contents in real time, the LPs can be used to perform transactions, print labels and reports for referencing container contents, and track nested LPs (for example, cartons on a pallet). Inventory control is tightly managed for packing, unpacking, consolidating, splitting, and updating LPs.

Shelf-life settings auto-generate expiration dates upon receiving and finished-good production, allowing food safety leadership to take advantage of GS1 barcodes during receiving for rapid data collection.

LP inventory avoids over-labeling products. A Global Trade Item Number (GTIN) will identify the “manufacturer” (the owner of the brand that appears on the product case) and the type of product inside that case.

This information will appear in both human-readable form and in a machine readable GS1 barcode. The GS1 barcode provides each trading partner in the supply chain with the ability to scan and maintain the encoded information. The GTIN is a globally unique product identification number based on GS1 global standards. These product identification standards are time tested and market proven, having been used in grocery stores for more than 40 years in the form of Universal Product Code (UPC) barcodes.

The cost of traceability technology tools is significantly lower than the violation of regulatory non-compliance. Understanding the risks of food safety incidents, the costs associated with them, and risk mitigation strategies are increasingly important for profitability and long-term economic sustainability. As always, traceability is the first line of corrective action and integral to meeting the Hazard Analysis Critical Control Points requirements.

Smith is the CTO and founder of WithoutWire Inventory Sciences, providing supply chain-based consulting and product strategy for a variety of industries. Reach him at traviss@withoutwire.com.

The post How License Plates Can Be Used To Meet The Food Traceability Requirement appeared first on Food Quality & Safety.

(Editor’s Note: This is an online-only article attributed to the April/May 2019 issue.)

Food safety is one industry that stands to gain significantly from cloud computing and storage, mainly because this approach to handling data leads to more accurate traceability for continually improving food safety through its ability to accumulate data and make it readily available for analysis and response. Given the endless number of variables in food processing from the loading dock to the receiving dock, cloud computing enables the process of keeping food safe to go to more of a granular level. This ability gives significant opportunities to analyze product status en route and to intercede the moment adverse conditions are detected.

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