Taking a step further in prioritizing technology and data modernization efforts, today the FDA announced the launch of a new Office of Digital Transformation. The office realigns the agency’s information technology, data management and cybersecurity roles into a central office that reports directly to the FDA commissioner. The reorganization will also help FDA further streamline its data and IT management processes, reducing duplication of processes, and promote best practices, technological efficiencies and shared services in a strategic and secure way.
“Good data management, built into all of our work, ultimately helps us meet and advance the FDA’s mission to ensure safe and effective products for American families,” said Acting FDA Commissioner Janet Woodcock, M.D., in an FDA news release. “The agency began these efforts because, as a science-based agency that manages massive amounts of data to generate important decisions and information for the public, innovation is at the heart of what we do. By prioritizing data and information stewardship throughout all of our operations, the American public is better assured of the safety of the nation’s food, drugs, medical devices and other products that the FDA regulates in this complex world. This reorganization strengthens our commitment to protecting and promoting public health by improving our regulatory processes with a solid data foundation built in at every level.”
Last year’s annual GFSI Conference was held in Seattle just weeks before the World Health Organization (WHO) declared COVID-19 a pandemic. This year’s event looked very different, as it joined the virtual event circuit—with hundreds of attendees gathering from across the globe, but from the comfort of their homes and offices. The 2021 GFSI Conference reflected on lessons learned over the past year, the fundamentals of building a better food system, and the idea that food safety is a collaborative effort that also encompasses training programs, effectively leveraging data and capacity building.
The pandemic provided the opportunity to reimagine safer, more resilient and sustainable food systems, said Dr. Naoki Yamamoto, universal health coverage, assistant director-general, UHC, Healthier populations at WHO. She also offered three clear messages that came out of the pandemic:
Food safety is a public health priority and a basic human right. Safe food is not a luxury.
Food safety is a shared responsibility. Everyone in the food chain must understand this responsibility and work towards a common goal.
Good public private partnership can bring new opportunities and innovative solutions for food safety. We need to seek more collaborative approaches when working across sectors to achieve foods safety.
During the session “Ready for Anything: How Resiliency and Technology Will Build Consumer Trust and Help Us Mitigate Disruption in the 21st Century”, industry leaders discussed how the pandemic reminded us that a crisis can come in many forms, and how applying the right strategy and technology can help us remain resilient and equipped to address the challenges, said Erica Sheward, GFSI director.
“When you think about business resiliency—it’s about our own, but most importantly, it’s about helping our customers become more resilient to those disruptions,” said Christophe Beck, president and CEO of Ecolab. He added that being able to predict disruptions, help customers respond to those disruptions, and provide real-time control to learn and prepare for the next pandemic or serious crisis is critical. Companies need to ensure their technology systems and contingency plans are ready to go, advised David Maclennan, chairman and CEO of Cargill. The key to a resilient food supply chain system is access and the ability to keep food moving across borders. And above all, whether dealing with a health crisis or a food safety crisis, consumers must always be front and center, said Natasa Matyasova, head of quality management at Nestle. “In short term, [it’s] first people, then business contingency, and then help the community as needed,” she said.
On January 25, 2021 Stop Foodborne Illness (STOP), in collaboration with Center for Science in the Public Interest, Consumer Reports, Consumer Federation of America and five STOP constituent advocates filed a petition with USDA Food Safety Inspection Service (FSIS) to reform and modernize poultry inspections. The goal of these reforms is to reduce the incidence of Salmonella and Campylobacter contamination in raw poultry thus drastically decreasing foodborne illnesses due to these pathogens.
According to the CDC, in 2019, these two pathogens combined were responsible for more than 70% of foodborne illnesses in the United States. As Mike Taylor, former FDA Deputy Commissioner for Foods and Veterinary Medicine, shares in his
Op-Ed, the time for change is now as the current regulatory framework is inadequate and has not delivered the desired results of reducing Salmonella and Campylobacter outbreaks.
Today, the USDA’s mark of inspection is stamped on poultry, although birds may exceed the performance standards; there are no clear consequences for establishments that do not meet the current guidelines. Without science-based standards or penalties for non-compliance, the burden of this problem falls upon consumers.
At STOP, we share the voices of consumers whose lives have been altered due to preventable problems such as this. Our constituent advocates share their journeys through severe foodborne illness to share the WHY of food safety. Real people, real lives are impacted when we do not demand action. STOP board member, Amanda Craten, shares her son Noah’s story:
“My toddler suddenly came down with a fever and diarrhea, but it wasn’t until weeks later that I learned that his symptoms, which nearly killed him, were caused by a multi-drug resistant strain of Salmonella.
After being admitted to the hospital, his doctors found abscesses in the front of his brain caused by infection and they were creating pressure on his brain. He underwent surgery and weeks of antibiotic treatments.
My 18-month son was seriously injured and permanently disabled as a result of Salmonella-contaminated chicken.” – Amanda Craten.
Because there are too many stories like Noah’s, STOP and its partner consumer advocacy organizations want to work with FSIS and industry to:
Develop real benchmarks that focus on reduction of known, harmful pathogens in poultry
Modernize standards to reflect current science
Implement on-farm control measures
Re-envision the standards to focus on the risk to public health
As a new administration begins, capitalizing on this opportunity to modernize poultry inspection that can benefit consumers and the food industry makes sense. STOP and its partners are hopeful that leadership at USDA/FSIS will take this opportunity to create consequential and relevant change. Ultimately, this transformation will reduce the incidence of foodborne illness due to contamination of poultry and increase consumer confidence in the USDA’s mark of inspection. Please comment on this petition.
At Stop Foodborne Illness, or STOP, we know about collaborative partnerships. For more than 26 years, affiliating with like-minded organizations to prevent foodborne disease is the mainstay of our success and continues to provide beneficial results today.
The mission to prevent illness and death due to contaminated food resonates with our allies and aligns with their goals to coordinate and expand efforts. At any given moment, STOP is working with a diverse spectrum of individuals and industries to move the needle on foodborne illness prevention. Today, STOP’s work is focused on constituent services and food safety policy with the overarching goal of public health. Below are examples of current collaborative projects that are uniquely effective.
Alliance to Stop Foodborne Illness
The Alliance to Stop Foodborne Illness (Alliance) is an initiative of STOP, leading food companies, and other organizations committed to the goal of preventing foodborne illness. For 25 years, Stop Foodborne Illness has communicated the compelling personal stories of people and families who have experienced serious foodborne illness or the death of loved ones. The goals of communicating these personal stories are to make clear why food safety must be a central value of the food system and to help motivate people in both the food industry and government to do their best every day to reduce hazards and prevent illness. Through the Alliance, STOP and leading food companies are collaborating to expand the reach and impact of personal stories to strengthen food safety cultures and prevent foodborne illness.
The Alliance to Stop Foodborne Illness has a mission to:
Forge partnerships between STOP and leading food companies to build trust and support strong food safety cultures.
Collaboratively design and implement innovative, well-tailored programs that make compelling personal stories an integral motivational element of food safety culture and training programs.
Expand the reach and impact of personal stories through outreach to the small- and medium-size companies that are key contributors to modern supply chains.
Current Alliance members: Costco, Cargill, Conagra Brands, Coca-Cola, Yum! Brands, Nestle USA, LGMA, Empirical Foods, Maple Leaf Foods, Mars, Walmart, Wegmans, and Amazon.
Working with those who have been impacted by severe foodborne illness is base to our prevention work. We engage our constituent/advocates in many projects and continually seek additional opportunities.
STOP’s new website houses a navigational map for anyone who is in crisis, post-crisis or managing the long-term consequences of surviving severe foodborne disease. This structured, informational composition was created by constituent/advocates that are sharing their lived experiences. This incisive work provides incredible insight into the journey that may lie ahead and how to manage the potential labyrinth.
With our partner, Center for Science in the Public Interest, we have created a national platform for survivors of salmonellosis and campylobacteriosis to speak about their experiences surviving these diseases.
The Alliance has created multiple working partnerships with individual constituent/advocates.
STOP’s speaker’s bureau provides opportunities for our constituent/advocates to share their personal stories with large groups in person or virtually.
A recent college graduate who is a constituent/advocate is leading the creation of a new program for the organization.
Dave Theno Fellowship
Dave Theno Fellowship is a partnership with Michigan State University (MSU) that provides a recent public health, food science, animal science or political science graduate (undergraduate or graduate degree) the opportunity to conduct two distinct research projects, engage in STOP programming, participate on coalition calls and earn a certificate in food safety from MSU.
STOP is working with MSU to create a new course for its Online Food Safety Program that focuses on food safety failures and the impact of those system breakdowns on consumers.
Early Detection of Foodborne Illness Research
In conjunction with North Carolina State University, Michigan State University, Eastern Carolina University and University of Michigan, STOP is engaging in research to identify gaps in knowledge and application of the 2017 Infectious Disease Society of America Clinical Practice Guidelines of the Diagnosis and Management of Infectious Diarrhea (IDSA) for healthcare workers. Our early findings have identified that most healthcare workers do not know about nor follow the IDSA guidelines, which include reporting of cases of infectious diarrhea and identification of the pathogen for identification and prevention of potential widespread outbreaks.
To support this research, STOP is completing a systematic literature review with the intent to publish.
Recall Modernization Working Group
STOP has been convening a group of experts comprised of individuals from academia, Alliance members, external industry partners, food industry associations, public health organizations, and industry consultants to deep dive into food recalls to define the current landscape, discuss systemic changes necessary for expedient and efficient execution of recalls for both industry and consumers and develop recommendations on how to accomplish those changes.
Everyone is susceptible to foodborne illness; thus, we need a varied, coordinated approach. Each of these partnerships helps our colleagues meet their goals while promoting prevention of foodborne illness by straddling both industry and consumer focused work. Executing our mission takes many forms and that requires diversity in partnerships, a shared vision and tangible, sustainable results.
To say that COVID-19 has been disruptive would be putting it mildly. The pandemic’s sudden and seismic impact has brought major upheaval across industries—the food industry and its supply chain included.
There was the initial panic buying that drove upticks in consumer demand for which few manufacturers and grocers were prepared, resulting in widespread product shortages. With restaurants closed, distributors and suppliers were left with considerable excess inventory—most of which ended up as waste and losses. Inside production sites and plants, many had to try and maintain their output with a reduced workforce, even as demand continued to climb. Meanwhile, some plants unfortunately have had to shut down operations on account of employees testing positive for COVID-19.
In the time since the outbreak, the food supply chain has stabilized to an extent. Store shelves are continuously being replenished with products. Restaurants have started reopening with new health and safety measures. Yet even as the industry takes gradual steps toward recovery, the underlying problem that led to the magnitude of COVID-19’s impact persists: Lack of visibility. There was lack of visibility into supply and demand and what was happening upstream and downstream across the supply chain, which prevented timely, proactive action to optimize operations in face of disruption.
Looking ahead, participants across the food supply chain will need enhanced end-to-end visibility so that they can work together to get ahead of the curve. As part of gaining this visibility, they will need the transparent exchange of information and cohesive collaboration to adapt especially as the food industry continues to see shifts in consumer behavior and the marketplace in the wake of COVID-19—particularly in the following three key areas.
While food producers have been working tirelessly to keep grocery store shelves and restaurant kitchens well stocked, there continues to be fluctuating availability on certain products, such as eggs, dairy, poultry and meat. This has led distributors and suppliers to increase their prices when selling these goods to stores and restaurants, who have had to then pass the additional costs on to consumers through their own price increases and surcharges, respectively. One report from CoBank, a cooperative bank part of the Farm Credit System, notes there could be as much as a 20% increase in the price of pork and beef this year due to supply issues.1 Many grocers have also implemented purchase limitations on consumers to combat shortages.
These downstream implications stem largely to uncertainty in the supply chain, with stores and restaurants unsure about available supply upstream and when they can expect to receive shipments. But if there was clearer visibility and transparency between production, distribution, transportation, food service and retail, then all parties could better anticipate and plan for supply shortages or delays. For instance, if a meat processing plant has to temporarily close due to cases of COVID-19, they can immediately communicate to the rest of the supply chain so that parties downstream can readily find alternative sources and minimize any necessary price inflations or other implications to consumers.
Even with the reopening of restaurants, people will likely choose to cook more of their meals at home. It was a trend that began with restaurant closures and will continue for the foreseeable future as consumers remain cautious of dining out. While this may bring tough times ahead for the food service industry, the grocery sector is seeing a huge lift in business. Research from restaurant management platform Crunchtime shows that, towards the end of June, restaurants were only seeing 64.5% of their pre-COVID-19 sales levels.2 At the same time, a study by Brick Meets Click and Mercatus reveals U.S. online grocery sales reached a record $7.2 billion in June, up nearly 10% over May.3
For food companies and brands, growth in the grocery sector has presented a challenge in the way of demand planning and forecasting. I’ve personally spoken with several company executives who have seen significant upticks in orders from their grocery channel partners—an increase for which they didn’t forecast—and are now struggling to adjust production levels accordingly to avoid the risk of excess production that would lead to unnecessary costs, wastes and losses. In such instances, real-time visibility into transactional activity and stock levels at the retail level would help production planners improve the accuracy of their forecasts and enable them to think steps ahead before orders come in and thereby optimally balance supply with demand. Stores would remain well stocked and the supply chain could flow in a more efficient and profitable way for all participants.
Without question, public health is the number one priority right now. Participants at each point in the food supply chain today need to communicate with each other, as well as to consumers, that they’re following best practices for social distancing, disinfecting and other precautions. It’s not to prevent the possible transfer of the virus via actual products, as the FDA notes there is currently no evidence of transmission through food or packaging. But rather, it’s to build greater confidence in the food supply chain—that everyone is doing their part to support individual and collective health and safety, which in turn prevents possible facility closures or other case-related bottlenecks that would inhibit consistent supply to the market.
There also has to be confidence that, amid these countermeasures for COVID-19, companies are still upholding their commitments to food safety, integrity and proper handling. What can support that confidence is data—shared data from every point in a product’s journey from source to shelf. The data should be transparent and available to all supply chain participants as well as immutable so that it is tamperproof and fully traceable should there be any problem, such as mislabeling or a foodborne illness. The data ultimately holds everyone accountable for their role in ensuring a safe food supply chain.
To achieve the level of visibility outlined above, the food industry will have to break away from legacy processes involving the siloed management of operational systems and databases. Instead, the disruption seen during COVID-19 and ongoing shifts in the marketplace should encourage companies to consider digital transformation and technologies that can enable a more cohesive and nimble food supply chain. These are technologies like blockchain, which provides a decentralized, distributed ledger to publish and share data in real time. Moreover, artificial intelligence that can leverage incoming real-time data to guide next-best actions, even when the unexpected occurs. Personally, I always return to the notion that the supply chain is a team sport. You need visibility to know what each team member is doing on the field and how to align everyone on a gameplay. The digital solutions available today offer that visibility and insight, as well as the agility to pivot as needed to obstacles along the journey from source to shelf.
Last week USDA’s FSIS issued a public health alert concerning ready-to-eat meat and poultry products that contain the onions recalled by Thomson International, Inc. (see below news brief). The products have been distributed by retail establishments that include Walmart, Kroger, HEB and Amana Meat Shop & Smokehouse. The USDA has made available the full list of products subject to the public health alert.
A multistate outbreak of Salmonella Newport has been traced back to red onions from Thomson International, Inc. a company based in Bakersfield, CA. As of July 31, 396 illnesses were reported in the United States, with 59 hospitalized across 34 states. In Canada, 120 cases have been confirmed, according to the Public Health Agency of Canada.
As a result, Thomson International is recalling all varieties of its onions (red, white, yellow and sweet) that “could have come in contact with potentially contaminated red onions”, according to an FDA alert.
The FDA, CDC, state and local agencies, as well as the Public Health Agency of Canada are investigating the outbreak. FDA recommends that consumers, restaurants and retailers refrain from eating, selling or serving any onions from Thomson International. The agency also states that any surfaces, containers or storage areas that may have come into contact with these products be cleaned and sanitized.
During the past year, the headlines have been filled with stories of foodborne illness, product recalls, and consumers becoming sick from tainted food. In a Q&A with Food Safety Tech, Sean O’Leary, CEO at FoodLogiQ, talks food safety, traceability, and how small percentages can translate into big victories for the food industry and for the people they serve.
Food Safety Tech: From your perspective, what is the current sentiment of consumers with regard to food safety?
Sean O’Leary: Over the last few years, the consumer mindset has changed about food in general. We’ve watched fad diets come and go; however, the interest in healthy ingredients and the concern about where food comes from has graduated from a passing trend to a full shift into the public consciousness. Consumers are much more discerning about what they eat; they also demand to know where their food comes from, how it was produced, and how it got to their table. We are living in the age of transparency, and consumer expectations are high.
And who can blame them? CDC statistics tell us that approximately 48 million people get sick every year from foodborne illnesses—and that’s just in the United States; 128,000 of them end up in the hospital. When a person is admitted to the hospital, it affects more than just that one individual. If the patient is the sole breadwinner of their family, their illness affects the entire family. If the person who gets sick is a child, there can be long-term consequences that trickle down to his or her whole community. And when you consider that 3,000 people die every year from foodborne illness—that’s one 9/11 every year. That’s unacceptable, because this is a preventable issue, and unfortunately, these illnesses are an underreported public health problem.
My challenge to the food industry is simple: What if we made just a 1% improvement in the number of cases of foodborne illness? That seems like such a small percentage, but when you do that math, that’s 480,000 people who don’t get sick this year; 1,280 people who aren’t admitted to the hospital; and 30 people who don’t die. Those are significant numbers.
FST: To help shed additional light on this subject, FoodLogiQ conducted a national survey to tap into how U.S. consumers feel about issues related to food transparency. What did you learn from those consumer responses?
O’Leary: We polled more than 2,000 people to gauge their sentiment around food traceability and their expectations for food companies regarding foodborne illness and product recalls. The survey also posed questions around consumer preferences regarding their food sources and how they are identified on food labels and menus. The results were enlightening, to say the least.
We learned that a brand or restaurant will pay a high price in terms of customer loyalty if they experience a food recall due to consumer illness. And those customers have some strong opinions regarding how quickly the brand or restaurant should address a food safety issue.
35% of survey respondents told us they would avoid an affected brand or restaurant for a few months, and maybe they would return after the issue had been resolved. Meanwhile, nearly 25% admitted they would never use the brand or visit the restaurant again.
Of the respondents who say they care about the quality of the food they eat, 55% say they expect a recall to be executed within 24 to 48 hours.
In reality, it sometimes takes weeks for a product to be pulled from the store or restaurant. This is frequently due to communication issues, since everyone along the supply chain—the grower, supplier, packing and distribution centers, corporate office, and the retailer or restaurant—all must be notified, and a recall plan must be set in motion. Unfortunately, that communication process takes time. When that communication takes place via email or by phone call, the people responsible for pulling product may not have the information they need or may have received misinformation. This can result in lag time, and potentially unsafe product can still get into the hands of consumers.
The faster a food company can address a recall situation and return to business as usual, the faster customers will come back. But comprehensive supply chain transparency is needed to be able to make swift, accurate decisions during this time of crisis. By having a robust end-to-end traceability program and technology that provides real-time data and visibility, companies facing a recall can isolate and surgically withdraw the tainted product out of the supply chain without recalling more items than necessary. That limits the disruption and the waste of good food, which saves the company money.
O’Leary: FoodLogiQ was honored to have the opportunity to share our intricate knowledge of the food supply chain, as well as best practices regarding whole chain traceability during this monumental meeting with the FDA with more than 250 food industry leaders.
In retrospect, one thing is clear—we’re in the midst of a pivotal time of change for the world’s food supply chain. In the United States, the food industry remained status quo for decades, but the introduction of FSMA has brought increased scrutiny and accountability; I think it’s made every food company pause and evaluate where they are with regard to food safety, and that’s a good thing. And now, with the launch of the “New Era” campaign, we’re coming together in a collaborative fashion to map out how technology tools, prevention measures, new business models, and an evolving culture of food safety can be merged as a framework for a long term food safety solution. I agree with the FDA; ‘Smarter Food Safety’ is people-led, FSMA-based, and technology-enabled. It will take all of us working together to reach that goal.
Rodents are vectors of more than 50 pathogens, including plague.1 While plague may be considered a problem of the past, according to the World Health Organization, between 2010 and 2015, there were 3,248 cases of reported plague worldwide and 584 deaths. While it is clearly not the 1300’s when the plague killed millions, the CDC confirms, “plague occurs in rural and semi-rural areas of the western United States, primarily in semi-arid upland forests and grasslands where many types of rodent species can be involved.” While the fact that plague is still lurking is a bit surprising, it should be no surprise that rodents can spread more than 50 diseases. Not the least of these diseases is Salmonella braenderup, the cause of recall of approximately 206,749,248 eggs in 2018. The good news: In the age of IoT, new technology can enable an immediate response to help prevent infestations from growing out of control.
With rodent populations on the rise due to climate change and the resultant public health issues in major cities across the United States, public health officials and pest managers face unimaginable challenges in staying ahead of rapidly growing and spreading rodent infestations. Earlier this year, Los Angeles had a typhus outbreak that resulted from a rat infestation near an encampment for those experiencing homelessness. The unsanitary conditions created a harborage for rats that spread the flea-borne illness. Cases of typhoid have doubled in the area since 2012. When and where will the next pathogen outbreak from rodent activity hit?
If that’s not frightening enough, it is important to highlight that once an infected, flea-carrying rodent enters a facility, eliminating the rodent does not always necessarily mean eliminating the presence of plague pathogens. The World Health Organization explains that once vectors have been introduced through rodents and their fleas, it is not enough to eliminate rodents. Vector control must take place before rodent control because “killing rodents before vectors will cause the fleas to jump to new hosts.”
Controlling the spread of pathogens via rodents is becoming increasingly important, particularly in sensitive environments like food processing and manufacturing facilities. Effective management begins with early and accurate detection and sustained through continuous monitoring. However, the traditional method of manual rodent inspection by its very nature cannot provide facility and pest managers with either early detection or continuous monitoring.
Thanks to IoT, monitoring systems can now be used in a wide variety of rodent monitoring devices inside and outside a facility. The systems transmit messages in real time over wireless networks and provide pest managers, facility management and public health officials with 24/7 visibility of rodent activity in a monitored location, which will enable more timely responses and help improve the effectiveness of mitigation efforts. Digital IoT technologies are rapidly becoming the modern proactive tool used to help predict and control rodent issues before they occur in an age when traditional, reactive methods are insufficient.
Over the course of three years, wholesale meat fraudsters in Brooklyn, NY, removed the USDA stamp on “Choice” beef and applied a counterfeit USDA “Prime” stamp to sell the fraudulently labeled meat at a premium price. A conviction can get the defendants a prison sentence of up to 20 years, even public health was not endangered, however, the USDA is taking integrity and quality of food very seriously.
Palmer A. Orlandi, Jr., Ph.D., senior science officer and research director in FDA’s Office of Foods and Veterinary Medicine, has been promoted to the rank of Rear Admiral and the U.S. Assistant Surgeon General. Orlandi received the flag-grade promotion during a ceremony held Thursday afternoon in the FDA Wiley Building.
“As the senior ranking officers in the Commissioned Corps, flag officers exemplify the core values for which Commissioned Officers of the U.S. Public Health Service are held in high esteem. Flag officers provide executive-level leadership within the Department and within the Agencies in which they serve. Our flag officers also carry the title of Assistant Surgeon General and, as such, we rely on them to support special initiatives and exhibit the highest caliber of public health leadership.” – Commissioned Corps of the U.S. Public Health Service
Orlandi joined FDA 20 years ago, beginning his work at a research lab for CFSAN. It was there that he developed rapid and molecular detection methods for Cyclospora and Cryptosporidia and the Microsporidia (emerging food-and waterborne protozoan parasites). In 2008 he became the science coordinator in the Division of Field Science in FDA’s Office of Regulatory Affairs (ORA) where he oversaw collaborative analytical methods programs for ORA and the Food Emergency Response Network. In 2012 Orlandi took on the role of senior science advisor to the chief scientist officer at the Office of Food and Veterinary Medicine. He played an active role in integrating science and research efforts across the agency’s foods program, and working to align research and lab programs to regulatory field lab needs.
Orlandi received a Commission as an officer in the U.S. Army in 1981. He has been an officer in the Commission Corps of the Public Health Service since 1991.
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